id|nct_id|description
1|NCT03057197|"~     Caudal epidural injections have been commonly performed in patients with low back pain and~     radiculopathy. Conventional caudal epidural injections, which the needle is advanced into~     the sacral canal, present a potential risk of penetration of the epidural venous plexus or~     dura. The investigators hypothesized that a new caudal injection technique, which the needle~     only penetrates the sacrococcygeal ligament without being inserted into the sacral canal,~     might represent a safe alternative, with a lower incidence of intravascular injections and~     patient's discomfort during the procedure than the conventional technique. The study is~     designed to investigate the influence of the depth of the inserted needle on successful~     epidurogram and clinical outcome in caudal epidural injections under the ultrasound and~     digital subtraction angiography.~   "
2|NCT03057184|"~     Adult Day Care Centers (ADCC) offer important relief and rest services for family~     caregivers. However, some caregivers report that behavioral and psychological symptoms of~     dementia (BPSD) arise when they prepare dependents for the ADC, especially when they have~     dementia. This issue increases stress for caregivers and contributes to a worsening of their~     mental health and quality of life. The present study evaluates the effectiveness of a~     behavioral intervention program aimed at reducing the reluctance of the dependent to attend~     the ADCC. We hope that reducing resistance will have a positive influence on the mental~     health of caregivers.~   "
3|NCT03057171|"~     Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which~     is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid~     tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced~     immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key~     post-transcriptional regulators of gene expression, differentiation. The investigators had a~     preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and~     PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced~     inflammatory cascade. However, there wasn't a previous study about expression of THRIL,~     PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of~     THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.~   "
4|NCT03057158|"~     Millions of women suffer from overactive bladder, and the changes in bladder function affect~     their quality of life. The study team believes that it needs to be better understand why~     women get overactive bladder in the first place so that better treatments can eventually be~     offered.~      The purpose of this study is to determine why women with insulin resistance are more likely~     to get overactive bladder. Overactive bladder is a type of bladder control problem that can~     cause some women to have bladder leakage. This problem is more common in women with diabetes~     and pre-diabetes, but it isn't known why.~   "
5|NCT03057145|"~     This research study is studying a combination of targeted therapies as a possible treatment~     for Advanced Solid Tumors.~      The study interventions involved in this study are:~        -  LY2606368~        -  Olaparib~   "
6|NCT03057132|"~     The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™~     Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to~     caustic body fluids from an ostomy, drain site or fistula.~   "
7|NCT03057119|"~     Substance misuse is a common problem among HIV+ individuals. Research suggests that a~     Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing~     substance misuse in the general older adult population; however these findings have not been~     verified in the more vulnerable HIV+ older adult population. The present study seeks to~     address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for~     older HIV+ adults in a in a primary care setting.~   "
8|NCT03057106|"~     Durvalumab is a new type of drug for many kinds of cancer. It is considered immunotherapy~     and not chemotherapy. Laboratory tests show that it works by allowing the immune system to~     detect cancer and reactivate the immune response. This may help to slow down the growth of~     cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in~     animals and has been studied in more than 5000 people and seems promising.~      Tremelimumab is a new type of drug for various types of cancers. It works in a similar way~     to durvalumab and may improve the effect of durvalumab. Tremelimumab may also help slow the~     growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink~     tumours in animals and has been studied in over 1200 people and seems promising.~   "
9|NCT03057093|"~     Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at~     elevated risk.~   "
10|NCT03057080|"~     The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the~     management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at~     the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive~     parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was~     performed and a PTA was carried out when feasible during the same session. All patients were~     followed until healing, amputation, death, or for at least two years. Short-term and~     long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients~     with worsening ulcers after PTA underwent bypass grafting or amputation.~   "
11|NCT03057067|"~     Results of recent systematic reviews suggest favorable results of embolization for the~     treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for~     several outcomes, including pain reduction, overall patient satisfaction, and technical~     feasibility. Reported complication rates appears relatively low.~      Pelvic vein embolization is a relatively new technology and the results may provide~     background for an evidence based decision to offer embolization of pelvic varicosities for~     women with PCS in Norway.~   "
12|NCT03057054|"~     This randomized clinical trial studies how well Lactobacillus plantarum works in preventing~     acute graft versus host disease in children undergoing donor stem cell transplant.~     Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus~     host disease in children, adolescents, and young adults undergoing donor stem cell~     transplant.~   "
38|NCT03056716|"~     In thoracic surgery, it is usual to place apical and basal drains for complete drainage of~     air and fluid out of the pleural cavity. The routinely used drains are mainly made of~     plastic. Recently silastic drains of smaller size are used without any complication. We~     designed a prospective randomized trial to compare the draining properties of the two types~     of drains following various resections in thoracic surgery.~   "
13|NCT03057041|"~     Intranasal fentanyl has been found to be safe and effective in the reduction of pain among~     pediatric and adult populations. The investigators hypothesize that patients who receive 100~     mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will~     report lower pain scores than those who receive placebo. The investigators will test this~     hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain~     reported during uterine aspiration between patients who receive either intranasal fentanyl~     or intranasal saline prior to the procedure.~   "
14|NCT03057028|"~     Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death.~     Anakinra has been used in patients with left sided heart failure, and the present study~     looks to determine if anakinra is safe and effective in patients with PAH. To accomplish~     this goal, we plan to evaluate for exercise improvement (as assessed by cardiopulmonary~     exercise testing) in 10 patients with PAH on anakinra.~   "
15|NCT03057015|"~     Total knee arthroplasty (knee replacement) is a common orthopedic procedure for~     osteoarthritis. This procedure is performed either under general anesthesia or spinal~     anesthesia; after the procedure in the recovery room, these patients undergo adductor canal~     block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this~     nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve~     the quality of pain control as well as the duration of pain relief. The primary local~     anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are~     epinephrine and dexamethasone.~      There is conflicting data available in the literature regarding efficacy of addition of~     clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data~     assessing the efficacy of this medication in adductor canal blocks.~      Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of~     surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be~     given to the acute pain service staff performing the nerve block. This will be mixed with~     local anesthetic solution and injected in the adductor canal under ultrasound guidance.~      The primary outcome measure will be the duration of analgesia, which will be assessed as the~     time interval between placement of adductor canal block to the first request of opioid~     analgesic by patients (which will be obtained from hospital electronic medical records).~     Secondary outcomes will include:~        1. Duration of sensory block, which will be assessed as the time interval between~          injection of local anesthetic and report of postoperative pain of 3 or more on an 11~          point scale (0=no pain; 10= worst pain imaginable) by the patient (this will be~          assessed every 4 hours).~        2. Duration of motor block, which will be assessed as the time interval between the onset~          of motor block to complete recovery of motor block by assessing straight leg raise~          strength (this will be assessed every 4 hours).~        3. Cumulative 24 and 48 hour opioid analgesic use.~        4. Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done~          every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24~          hours.~   "
16|NCT03057002|"~     In this study the investigators propose to detect early mitochondrial metabolic changes in~     the heart in patients with a positive genotype and phenotype for Hypertrophic Cardiomyopathy~     (HCM) using a novel hyperpolarized [1-13C]pyruvate Magnetic Resonance Imaging (MRI)~     methodology.~   "
17|NCT03056989|"~     Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult~     subjects with cystic fibrosis.~   "
18|NCT03056976|"~     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture~     retained by one and two implants and the mandibular fixed prosthesis retained by four~     implants, based on a randomized clinical trial.~   "
19|NCT03056963|"~     The purpose of this study is to examine the efficacy of a guided imagery paradigm for~     reducing negative ways of thinking about the self. There will be at least 60 participants~     enrolled at the University of Texas at Austin. Participants will be randomly selected to~     receive one of two types of trainings, each over the course of two weeks. Participants will~     undergo the training exercises at home. The training exercises will help them to think~     differently about themselves.~   "
20|NCT03056950|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet,~     leads to beneficial changes in muscle strength at low resistance and minimal stress on the~     nearby joint. This novel resistance training has the potential to greatly improve muscle~     strength gains in individuals who are unable, for medical reasons, to perform the high~     resistance exercises typically required to improve strength. Our study will examine the~     effect of this technique on strength recovery following distal radius fracture treated with~     cast immobilization (non-operatively). The primary objective of the intervention is to~     achieve accelerated recovery of forearm, wrist and hand function as assessed using measures~     such as grip/pinch strength, validated questionnaires, and functional outcome testing.~     Occlusion training can potentially serve as a specialty intervention for rehabilitation~     patients, reduce the cost of care, and improve the treatment options for both patients and~     providers.~   "
21|NCT03056937|"~     The hypothesis of this study is that reductions in body weight could improve inspiratory~     muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese~     individuals and obese individuals with metabolic syndrome.~   "
22|NCT03056924|"~     Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with~     medications that suppress the immune system. These patients are therefore at increased risk~     for developing infections, such as influenza, pneumonia, and hepatitis B, which may be~     prevented by vaccination. While awareness is increasing among gastroenterologists of the~     importance of vaccinations in the IBD patient, there continues to be some question of the~     effectiveness of vaccination in immunosuppressed patients. It has been previously shown that~     patients on immunosuppressive therapy with certain biologic medications (the TNF-blockers:~     infliximab and adalimumab) had an impaired immune response to vaccination as compared to~     healthy controls, as the mechanism of immunosuppression for these agents is systemic.~     Vedolizumab, a biologic medication for CD and UC approved in May 2014, targets the α4β7~     integrin, a key component of gut immunity, and as such it has been hypothesized that with~     this agent effects are gut specific. There is limited data that suggests that in healthy~     patients given vedolizumab do not have an altered response to parentally administered~     vaccines, however there are no studies in the CD and UC population describing this.~     Additionally, IBD patients treated with vedolizumab are frequently also on concomitant~     therapy with an immunomodulator (6-mercaptopurine, azathioprine, or methotrexate), and these~     patients ability to mount an immune response has not been demonstrated.~   "
23|NCT03056911|"~     The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as~     therapeutic substance for nucleolysis application in the patients with cervical disc hernia~     who had chronic pain and weakness on the neck, shoulders and arms~   "
37|NCT03056729|"~     The primary objective of the study is to evaluate the safety and tolerability of~     single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and~     participants with Alzheimer's disease (AD). A secondary objective of the study for both~     healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK)~     profile of BIIB076 after single-dose administration. Another secondary objective is to~     evaluate the immunogenicity of BIIB076 in serum after single-dose administration.~   "
24|NCT03056898|"~     Health professionals attending the American Association for Family Physicians (AAFP) meeting~     at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM booth will be invited~     to complete an omega-3 dietary intake survey and have a drop of blood taken by finger stick~     by a health professional for blood fatty acid analysis. Dried blood samples on filter paper~     will be sent to an outside laboratory (OmegaQuant LLC) for analysis. Within 2 weeks,~     participants will receive an Omega-3 Index Test report by email from OmegaQuant LLC. After~     removing personal information, OmegaQuant LLC will share blood fatty acid and omega-3~     dietary intake results with the sponsor.~   "
25|NCT03056885|"~     This study evaluates the local cytokine inflammatory response during one lung ventilation in~     patients undergoing pulmonary lobectomy or wedge resection. We compare two different~     ventilation strategies: a conventional strategy with a protective strategy.~   "
26|NCT03056872|"~     Alcohol dependence is among the most common and costly public health problems affecting the~     nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a~     co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months~     following AUD treatment. Dysregulation of biological stress-mood systems predict and~     correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation~     correlates with improved AUD treatment outcomes but has not been examined with respect to~     AUD recovery and relapse in co-occurring AUD+AnxD.~      The objectives of the proposed research are to 1) evaluate the effect of co-occurring AnxD~     on the severity of biological stress-mood system dysregulations in AUD inpatients at~     pre-treatment, 2) evaluate the effect of co-occurring AnxD on the persistence of stress-mood~     system dysregulations in AUD inpatients in the months following treatment, 3) evaluate the~     effects of treatment on biological stress-mood system re-regulation among AUD patients with~     co-occurring AnxD, and 4) evaluate the effect of re-regulation change in biological~     stress-mood system function on AUD clinical outcomes.~   "
27|NCT03056859|"~     This is a single-arm observational trial of a device (Compass Vascular Access, Centurion~     Medical Products, Williamston MI). The device is a compact, sterile, single-use~     extravascular blood pressure transducer. This pressure measurement aids in confirmation of~     appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI~     ≥35 who require central venous catheterization for clinical reasons independent of the~     existence of this study. The primary outcome is operator satisfaction.~   "
28|NCT03056846|"~     The purpose of this research study is to evaluate the effect of a daily supplement of~     probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium~     longum MM-2) on stress-associated gastrointestinal function in university students during~     the time of semester exams.~   "
29|NCT03056833|"~     Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance~     the response to platinum-based therapy and maintenance therapy will slow ovarian cancer~     tumor growth leading to prolongation in progression free survival.~   "
30|NCT03056820|"~     The purpose of this study is to compare the effect of the 25° head-up position versus the~     55° head-up position on tolerable apnea time (TAT) after induction of general anesthesia in~     patients with a body mass index (BMI) of 30-40.~   "
31|NCT03056807|"~     The purpose of this study is to compare the effect of the 25° head-up position versus the~     55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for~     laparoscopic adjustable gastric band surgery following maximum preoxygenation and~     rapid-sequence induction (RSI) of anesthesia.~   "
32|NCT03056794|"~     Children and adults with pyruvate dehydrogenase complex (PDC) deficiency are participating~     in a research study seeking to better understand the genetic causes, symptoms, usefulness of~     current treatments, and outcomes for these disorders. The research project involves~     completing a questionnaire about the individual or family's medical history and experiences~     with PDC deficiency, review of medical records by the researchers, and in some cases,~     advanced genetic testing. A blood draw will be requested, and an optional skin biopsy is~     part of the study for some participants.~   "
33|NCT03056781|"~     The purpose of this research is to understand how the emotions of people with different~     mental health concerns (e.g., people with schizophrenia, people with major depressive~     disorder) differ from individuals without mental health concerns. A large body of literature~     suggests that people with mental illnesses have emotional abnormalities compared to healthy~     individuals, but a number of these abnormalities are not well understood. For example, often~     people with schizophrenia report on questionnaires that they experience fewer pleasant~     emotions when talking with other people, but some evidence suggests these individuals report~     a similar amount of pleasant emotion when they are actually engaged in a pleasant activity.~     Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more~     real-world setting. In the tasks in the current proposal, participants will engage in a~     series of tasks designed to assess their emotional functioning. These tasks involve viewing~     emotional stimuli on the computer, engaging in social interactions, and consuming small~     amounts of food. In all tasks, participants will make ratings of their experiences of~     pleasure (and displeasure). We will then compare the experiences of patient groups to those~     of healthy individuals to test how emotional ratings might differ across these tasks.~   "
34|NCT03056768|"~     Objectives: 1-year multidomain health promotion on prevention of physical and cognitive~     decline for community-living older people.~      Design:~      Methods: Randomized controlled trial~      Setting:~      Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or~     older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health~     promotion (physical, cognitive, nutritional intervention)~      Measurements:~      Primary outcome includes frailty status and cognitive performance. Secondary outcomes~     include depressive symptoms, nutrition assessment, and functional capacity; All the~     variables were measured at 0, 6, 12 months. The effect of intervention was investigated by~     intention-to-treat analysis.~   "
35|NCT03056755|"~     Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+,~     HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6~     treatment with an aromatase inhibitor (AI) or fulvestrant~   "
36|NCT03056742|"~     This study is being conducted as an extension of the phase II clinical trial~     SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued~     clinical study in consultation with ICMR, as per recommendation of Cellular biology based~     therapeutic drug evaluation committee (CBBTDEC).~   "
39|NCT03056703|"~     The primary objective of this study is to compare the bioavailability of a single dose of a~     new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a~     commercially available 500 mg fast release tablet and to test for bioequivalence of the new~     versus the commercial product in healthy adult subjects.~   "
40|NCT03056690|"~     The purpose of this study is to assess analgesic efficacy of ASP0819 relative to placebo as~     well as the safety and tolerability.~      This study will also assess treatment differences in physical function as well as the~     improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning)~     of ASP0819 relative to placebo.~   "
41|NCT03056677|"~     After meals, the level of glucose rises in the circulation. In some individuals who are~     overweight and older, blood glucose can rise to levels which can damage tissues and cause~     health problems. Usually the hormone insulin, released from the pancreas, effectively lowers~     blood glucose. However, in overweight and older people insulin is less effective. Certain~     foods can lower the rise in blood glucose, particularly proteins. This works by increasing~     the release of a hormone from the gut called Glucagon-Like Peptide 1 (GLP-1), which in turn~     increases the release of insulin. A Component of milk left over after cheese making, termed~     Whey protein, is particularly good at releasing GLP-1. Whey protein is used as a food~     additive and taken as a supplement to help build muscle. Whey protein is a mixture of~     proteins which the investigators have modified to be more effective at lowering blood~     glucose. Using laboratory tests the investigators identified a protein present in Whey that~     does not increase levels of GLP-1 and removed it. It's removal raises the levels of other~     proteins which are more effective. In this study, the investigators would like to test the~     effectiveness of the modified whey protein. To do this, 30 older, overweight volunteers~     will be recruited and given the modified whey protein, a normal whey protein or a mixture of~     amino acids and then a breakfast meal to raise their blood glucose levels. These drinks will~     be given in a randomised sequence 1 week apart. On each visit, blood samples to measure~     blood glucose and related hormone levels will be taken. As GLP-1 can also have an effect on~     appetite, the investigators will measure the effect of the modified whey protein on~     subsequent appetite in the volunteers by asking them how hungry they feel.~   "
42|NCT03056664|"~     Here investigators will carry out this phase II clinical trial to explore a effective~     therapeutic regimen of MSC in the Crohn's perianal fistula.~   "
43|NCT03056651|"~     The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an~     observational study on selected patients with advanced refractory heart failure. The purpose~     of the study was to examine the comprehensive management of HF in the day-care unit in terms~     of the safety and its impact on the rehospitalization and mortality rates in patients with~     advanced refractory HF.~   "
44|NCT03056638|"~     Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that~     allows the physician to deliver more radiation dose in a single session. Because of this,~     the number of radiation sessions can be reduced from the typical 45-48 sessions, as in~     conventional daily session radiation, to 5 sessions given every other day over a week and a~     half. Giving the radiation at a higher dose during each treatment may be more effective in~     killing the prostate cancer cells than the standard way of using external radiation therapy~     where a small amount of radiation is given over many sessions.~      Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat~     intermediate risk prostate cancer. This therapy works by reducing the level of testosterone~     and stopping them from affecting your cancer. The ADT used in this study is known as~     Degarelix. Degarelix is an approved medication that reduces the body's production of~     testosterone; this medication is usually given to all men with intermediate risk prostate~     cancer getting external radiation.~      This study is a randomized study to find out whether combining stereotactic (also known as~     precision) radiation to the prostate cancer combined with a short course of Degarelix will~     result in a greater likelihood of killing the cancer in the prostate compared to~     stereotactic radiation therapy given alone. It has been shown that the combination of~     radiation with medications that interfere with testosterone production and its effects makes~     prostate cancer cells more sensitive to the radiation.~   "
45|NCT03056625|"~     Vitamin A deficiency (VAD) remains a public health problem that occurs in children and~     women. WHO estimates that 190 million preschool age children (under five years of age) and~     19.1 million pregnant women have inadequate concentrations of retinol . VAD may increase~     risk of morbidity and mortality during childhood, pregnancy and postpartum period . In~     developing countries, vitamin A status in lactating women is not optimal. Even in the United~     States, vitamin A status of low income pregnant women is marginal. Therefore, women of~     reproductive age are at risk of vitamin A depletion which compromises the vitamin A status~     of breastfed infants. Vitamin A is transferred to milk from both retinol binding protein~     bound and chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A,~     the transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This~     results in all infants born with very low stores of vitamin A . Therefore human milk is~     still the best vitamin A source for infants. The concentration of vitamin A in breast milk~     is highest in the first 21 days postpartum (colostrum in the first 4-6 days and transitional~     milk in the next 7-21 days. Breast milk vitamin A concentrations and an infant's vitamin A~     status are based on maternal dietary intake. Breast milk retinol concentrations are a useful~     tool and a unique indicator for lactating women and represents extrapolations of vitamin A~     status of breastfed infant.~      In high risk vitamin A deficiency areas, prior recommendation for lactating women was to~     give two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of~     impact evidence of this regimen led to the WHO's withdrawal of such recommendation as a~     public health policy .~      Food-based intervention has been regarded as a sustainable approach to improve population~     vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid~     maize resulted in significant increase in liver stores in nursing piglets and significant~     higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin~     A supplement .~      Previous efforts to fortify staples or common vehicles with vitamin A offer promising~     solution to prevention of vitamin A deficiency in vulnerable population . Food fortified~     with vitamin A has potentials to improve women's vitamin A status and to increase the~     vitamin A concentrations of breast milk . Rice as the most important staple food in~     Thailand, represents the culture of consumption and lifestyle of Thai people . Recent study~     in Thai school children fed with extruded rice grains fortified with zinc, iron and vitamin~     A every weekday for 2 months, significantly increased liver stores of vitamin A, as assessed~     with a stable isotope technique . Likewise, fortification of rice with vitamin A may also~     benefit mothers during lactation.~      The outcomes of this study will be useful to guide the promotion of food-based strategies to~     improve vitamin A status of mother and infant during lactation.~   "
46|NCT03056612|"~     The aim of this study is to assess prospectively the critical period prior to the~     development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and~     pathophysiological processes associated with the development and clinical course of ACLF (2)~     and to identify the precipitating events of ACLF (3).~   "
47|NCT03056599|"~     This is a feasibility study in patients with localized or metastatic soft tissue sarcoma~     undergoing surgery to determine how sarcoma in situ responds to injected microdoses of~     anti-cancer therapeutics.~   "
565|NCT03049787|"~     This study aims to evaluate physical therapy (standard of care) and home exercise vs. home~     exercise alone for the treatment of adhesive capsulitis.~   "
48|NCT03056586|"~     Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or~     cystocele or rectocele, or mixed. About half of them will require surgical repair for the~     prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence~     of the prolapse, which in some cases requires second operation.~      In this study the investigators want to investigate whether a vaginal pessary inserting in~     the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.~   "
49|NCT03056573|"~     Expand the indication of the Portico TF Delivery System and obtain approval of the~     Alternative Access Delivery System~   "
50|NCT03056560|"~     This study will evaluate an innovative video bystander program, which has the potential to~     be implemented broadly and cost-effectively across college campuses. Half of the~     participants will receive the video bystander program, and the other half will not.~   "
51|NCT03056547|"~     To explore biological mechanisms in human model of induced dyspnea, in order to remove the~     source of dyspnoea, to modify cerebral impact and to allow the development of targeted~     therapies.~   "
52|NCT03056534|"~     R3 Delta Post-Approval Study U.S.~   "
53|NCT03056521|"~     Patients are randomized into 2 groups. The intervention group which receives preoperative~     counseling about pain and a control group which does not receive this counseling.~      The patients are followed up looking at pain scores and pain experience and satisfaction~     with pain management for 2 days post operative.~   "
54|NCT03056508|"~     This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to~     exercise alone (EX) intervention, on brain structure and function as well as blood~     biomarkers in older adults with subjective cognitive decline (SCD) and vascular risk~     factors. The overall hypotheses are that a combined EX+NUTR, relative to EX, intervention~     will evoke more positive changes in brain structure (e.g. hippocampal volume), neural~     activity (e.g. task associated functional activations monitored through fMRI), and cognitive~     performance. These changes will be associated with an improved metabolic profile, reductions~     in inflammatory cytokines and oxidative burden, and greater intervention compliance.~   "
55|NCT03056495|"~     This Clinical Trial is an open, non-randomized Phase Ib study to determine the maximal~     tolerable dose (MTD) of Vorinostat in Alzheimer disease (AD) patients between (including) 55~     and 90 years with mild symptoms. The MTD in this study is defined as the dose that leads to~     maximum toxicity with Common Toxicity Criteria (CTC) grade 1 symptoms.The safety and~     tolerability of Vorinostat in this group of study participants should be tested.~   "
56|NCT03056482|"~     Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is~     expected to increase in prevalence with continuing liberalization of marijuana and~     recognition of the disease. Regardless of whether the association with heavy cannabis use is~     recognized, there is well-documented resistance to traditional anti-emetic treatment. Given~     promising reports of the use of intravenous haloperidol, a randomized controlled trial~     comparing it to the commonly administered anti-emetic ondansetron will contribute to the~     management of CHS~   "
57|NCT03056469|"~     This study investigates if integration of patient-reported outcomes in the follow-up of~     patients with newly diagnosed, not curable, chronic hematological cancer changes the number~     and kind of supportive care interventions. Furthermore, this study investigates if the~     patients feel that they are more involved in a positive way when patient-reported outcomes~     are integrated in the follow-up of their cancer.~   "
58|NCT03056456|"~     The study will be conducted in participants with type 1 diabetes mellitus to investigate how~     the human body processes LY900014, a new blood sugar lowering insulin, and its effect on~     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability~     will be documented. The study will last about 4 to 11 weeks for each participant.~   "
59|NCT03056443|"~     The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP)~     initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure~     patients on reducing 30-day hospital readmission rate through a clinical trial.~   "
60|NCT03056430|"~     The purpose of this study is to determine whether intensive slackline training improves~     spatial orientation abilities, balancing skills and causes neuroplasticity in related brain~     cortical regions.~   "
61|NCT03056417|"~     The current project will use the Complete Health Improvement Program (CHIP) as an~     intervention for patients with chronic pain. CHIP is a nationally recognized program that~     encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and~     social support. Patients with chronic pain who enroll in CHIP classes will be monitored and~     compared to patients with chronic pain who are not enrolled in CHIP classes. It is~     hypothesized that patients who complete CHIP will have increased telomerase activity and~     longer relative telomere length at follow-up when compared to those who do not enroll in the~     program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and~     telomeres are the caps on these chromosomes that protect them from damage. Telomere~     shortening occurs normally with aging and once they are too short to replicate cellular~     death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by~     extending the ends of chromosomes. Research has shown that patients with chronic pain may~     have shorter telomeres relative to others of the same age. This study will investigate this~     association further.~   "
62|NCT03056404|"~     This study aims at identifying bird proteins useful for diagnostic tests to determine the~     cause of Bird Fancier's Lung (BFL).~   "
94|NCT03055988|"~     The objectives of the study are to explore the effect of treatment with tiotropium +~     olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC~     on:~        -  reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic~          resonance (CMR) imaging,~        -  measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA),~        -  reduction of hyperinflation assessed with body plethysmography and~        -  post dose spirometry.~   "
95|NCT03055975|"~     Sampling of accessed root canals with endodontic paper points during treatment and~     immediately pre-obturation of endodontic root canals was carried out.~   "
96|NCT03055962|"~     Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study~     conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50~     milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged~     50 to 85 years.~   "
63|NCT03056391|"~     Acute kidney injury is a common complication of severe Plasmodium knowlesi malaria, and an~     important contributor to mortality.~      The exact pathogenic mechanisms of AKI in knowlesi malaria are not known, however it is~     hypothesised that haemolysis of red blood cells and subsequent release of cell-free~     haemoglobin leads to oxidative stress and lipid peroxidation in the renal tubules.~      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol acts as~     a potent inhibitor of hemoprotein-catalyzed lipid peroxidation. In a proof of concept trial,~     paracetamol at therapeutic levels was shown to significantly decrease oxidative kidney~     injury and improve renal function by inhibiting the hemoprotein-catalyzed lipid peroxidation~     in a rat model of rhabdomyolysis-induced renal injury.~      The investigators hypothesize that this novel inhibitory mechanism of paracetamol may~     provide renal protection in adults with knowlesi malaria by reducing the hemoprotein-induced~     lipid peroxidation that occurs in haemolytic conditions. As there is currently no consensus~     that exists concerning adequate medical treatment for severe malaria complicated by~     intravascular haemolysis and AKI, the potential application of paracetamol would be of~     benefit, especially as it is safe and widely available.~   "
64|NCT03056378|"~     The purpose of the study is to determine the safety of pooled red blood cells (RBCs)~     compared to standard leukoreduced RBC products stored in additive solution. The primary~     objective is to determine if there is no significant difference in transfusion associated~     adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to~     determine if there are no significant differences in new antibody and new positive direct~     antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product~     groups.~   "
65|NCT03056365|"~     The SAMBA study aims to assess the safety and cost comparison of the management of~     outpatient alcohol detoxification, between an advanced nurse protocol on the one hand~     (experimental group), and a GP-based treatment on the other hand (standard-of-care group).~      In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol~     based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores,~     which are calculated at every consultation, advanced nurse can adjust the diazepam dosing.~     In case of any serious adverse event or uncontrolled withdrawal complication, an addiction~     specialist stands in back-up and can be appealed to decide whether the outpatient detox can~     be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage~     patients as they wish.~   "
66|NCT03056352|"~     Post-traumatic headache is common. We are determining short and longer-term outcomes among~     patients treated for post-traumatic headache with IV metoclopramide.~   "
67|NCT03056339|"~     The goal of this clinical research study is to learn if giving genetically changed immune~     cells, called NK cells, after chemotherapy will improve the disease in stem cell transplant~     patients with relapsed (has returned) and/or refractory (has not responded to treatment)~     B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of~     CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia.~     The safety of this treatment will also be studied.~   "
68|NCT03056326|"~     Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic~     lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable~     inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed~     to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in~     healthy male subjects.~      The study will comprise two parts:~      Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.~      Part 2 will consist of four sequential cohorts of healthy male subjects to assess the~     safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333~   "
69|NCT03056313|"~     The duration of labor is decisive for maternal and fetal health. Poor progression often~     results in tired mothers, bad experience, delivery complications and a demand for cesarean~     section in next pregnancy. Proactive support of labor is a method originally from the~     Netherlands.~      The main idea is to define start of active labor earlier than the traditional 3-4 cm~     opening of the cervix and regular contractions to be cervix < 0.5 cm in length, and 1 cm~     opening and painful contractions. From this point, it is expected to be a progress of~     1cm/hour opening of cervix. If not, progress is supported by amniotomy or stimulation of~     contractions.~      This method is embraced by several clinics with great enthusiasm. However, there are no~     randomized controlled trials to prove that this method is better than others.~   "
70|NCT03056300|"~     The primary objective of this trial is to demonstrate the effectiveness of the powered~     vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during~     Video-Assisted Thoracoscopic Lobectomy.~   "
71|NCT03056287|"~     This project will assess the effects of aerobic exercise training (AET), repetitive~     transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well~     as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are~     established stand-alone treatments for non-stroke related depression, though neither has~     been adequately studied post-stroke. Furthermore, substantive research indicates that AET~     improves post-stroke locomotor function, thus offering a novel approach for treating PSD as~     well as an established vehicle to study the effects of PSD on response to rehabilitation.~      The purpose of this project is to determine the impact of AET, rTMS and their combination~     (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to~     guide the development of a future clinical trial. A total of 40 depressed post-stroke~     subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET~     and rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed~     with mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects~     will complete 8 weeks of AET so as to allow us to determine the effects of PSD on response~     to training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week~     period, three times per week on non-consecutive days. Measures of depression (HRSD17) as~     well as self-selected walking speed (SSWS) will be performed prior to the initial treatment~     session of each week as well as 8 weeks following cessation of treatment. Additional~     measures of locomotor function (walking endurance and amount of daily community stepping)~     will be assessed prior to training (pre), following 4 weeks of training (mid), upon~     completion of 8 weeks of training (post) as well as 8 weeks following cessation of training~     (follow-up), allowing determination of the efficacy (and persistence) of training on these~     outcomes.~   "
72|NCT03056274|"~     This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid~     in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three~     NHS hospital sites, over an 18 month period.~   "
97|NCT03055949|"~     The purpose of this study is to determine whether an early rehabilitation program in~     surgical intensive care unit is safe and effective in preventing critical care illness and~     intensive care unit acquired weakness.~   "
98|NCT03055936|"~     This is a phase I PK study in healthy males.~   "
73|NCT03056261|"~     Sixty neonates and infants will be enrolled and randomised into two groups of n=30 each .~     For their surgical procedures, one group general (GA) anaesthesia the second group will~     receive a combined general and epidural anaesthesia (CGEA).~      Anaesthetic technique:~      Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and~     fentanyl (2-4 µg.kg-1) and will receive rocuronium bromide (0.5 mg.kg-1) to facilitate~     endotracheal intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an~     air/oxygen mixture as well as intravenous fentanyl as required.~      In the (CGEA) 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter,~     followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up~     to 48 hours postoperatively. Assessment of anaesthetic efficacy will be measured~     Intraoperative care vital signs. And will continuously be monitored with a Datex AS/3~     (Engestrom®, Helsinki, Finland) monitor.~      The use of antibiotic prophylaxis will be determined by the degree of bowel contamination~     during surgery, with the commonest regimen consisting of penicillin, gentamicin and~     metronidazole will be administered. Antibiotics will be continued for 36-48 hours~     postoperatively to prevent infection arising from the disturbed bowel flora.~      Postoperative care, following surgery, will be conducted. The feeding volume will be~     increased in steps as long as the volume of regurgitated fluid will be less than 20% of the~     administered breast milk or formula volume. Full feeding will define as oral tolerance of at~     least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding~     will withheld until symptom resolution. The nasogastric tube will be removed on bowel~     function restoration The CRIES score will be use to assess the severity and duration of~     postoperative pain during the patients' NICU stay. If the CRIES score is ≥4, fentanyl will~     be continuously intravenously infused in both study group. Fentanyl will be also~     administered to CGEA patients who experienced pain despite a continuous epidural infusion at~     1-5 µg.kg-1.h-1. The amount of fentanyl required for adequate postoperative pain relief will~     be recorded in both groups.~   "
74|NCT03056248|"~     A growing body of pre-clinical evidence suggests that glycogen synthase kinase 3β (GSKβ) is~     implicated in the development and progression of acute kidney injury (AKI). Lithium is a~     naturally occurring standard inhibitor of GSKβ. The purpose of this study is to examined if~     low dose lithium carbonate is able to reduce the incidence of AKI in patients undergoing~     cardiac surgery who are placed on cardiopulmonary bypass during surgery. We hypothesize that~     low dose lithium might reduce the incidence and duration of AKI in patients undergoing~     cardiac surgery who are on cardiopulmonary bypass.~   "
75|NCT03056235|"~     The study is designed to evaluate the efficacy of two formulations of a cross-linked~     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred~     to as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered~     as intradermal implants.~   "
76|NCT03056222|"~     The aim of the study is to compare the acute procedure and safety outcomes as well as long~     term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically~     Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated~     Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D~     Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).~   "
77|NCT03056209|"~     The purpose of this First In Human study is to investigate the safety and tolerability of~     KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of~     KL1333 after a single oral dose.~   "
78|NCT03056196|"~     Introduction~      Undiagnosed deep vein thrombosis (DVT) can lead to significant morbidity and mortality,~     including death from DVT-associated massive pulmonary embolism (PE). While several validated~     clinical prediction rules, blood test and imaging modalities exist to investigate a~     potential DVT, there is currently a lack of rapid, accessible and reliable methods to~     exclude the possibility of DVT without resorting to formal venous duplex scanning.~      Currently, the use in the ED of a validated clinical prediction rule combined with~     high-sensitivity D-dimer test has a poor predictive value, as 75-90% of patients suspected~     of DVT have a negative formal venous duplex scan.~      Compression bedside ultrasound has however recently been shown to be a safe, rapid and~     accurate method for the diagnosis of proximal DVT in the emergency department with a high~     sensitivity and specificity (combined sensitivity and specificity of 96.1% and 96.8%,~     respectively1).~      Research Question~      In the present study, the investigators will primarily assess whether two-site compression~     POCUS combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED~     patients regardless of the Wells criteria.~      Methods~      This is a single-center, prospective, observational study carried out over one year in the~     Emergency Department of the Jewish General Hospital in Montreal, Quebec. The investigators~     aim to enroll a convenience sample of 475 patients aged 18 years and older presenting to the~     ED with symptoms suggestive of a DVT. All enrolled patients will receive the standard of~     care required for a lower leg DVT presentation. After calculating Patients DVT risk using~     modified wells criteria, all patients will undergo POCUS for DVT followed by a D-dimer test.~     Based on their results, patients will either undergo formal duplex scanning, or will be~     discharged without further testing and receive a three-month phone follow-up.~      A true negative lower leg DVT will be defined as follows:~        1. Negative follow-up phone questionnaire for patients who were sent home with no formal~          duplex venous scanning.~        2. Negative formal duplex venous scanning for patients who were deemed likely to have~          lower leg DVT using the Wells score, with a negative D-dimer and POCUS~      Age-adjusted DVT was added to account for below knee DVT and avoid the need for patients to~     return for fellow up duplex study in 1 week.~      To estimate our technique's sensitivity with a 4% margin of error with 95% confidence~     intervals, 92 confirmed DVT patients are needed. The investigators expect to recruit a total~     475 patients within one-year period at the JGH (95 DVT-positive patients and 380~     DVT-negative patients).~      Impact~      The use of compression bedside ultrasound with a negative age-adjusted D-dimer test to rule~     out DVT in the ED may accelerate the decision regarding patient disposition and~     significantly decrease the length of patient stay in the ED. In addition, it may help avoid~     unnecessary medical interventions and diagnostic tests, thus representing potential quality~     of care and cost-saving improvements as well.~   "
79|NCT03056183|"~     Aim 1: To collect data on a Depression Care Transition (DCT) program's association with~     self-care behaviors as measured by medication adherence and clinic visit attendance, after~     discharge. Hypothesis 1: Compared with usual care, patients who receive the DCT intervention~     will have significantly greater medication adherence and clinic visit attendance, at 30, 90,~     and 365 days after discharge.~      Aim 2: To collect data on DCT's association with clinical/health outcomes as measured by~     depression severity, functional status, and overall physical and mental health, after~     discharge. Hypothesis 2: Compared with usual care, patients who receive the DCT intervention~     will have significantly larger improvements in depression severity, functional status, and~     overall physical & mental health at 30, 90, and 365 days after discharge.~      Aim 3: To collect data on DCT's association with utilization outcomes as measured by~     readmissions, length of subsequent hospital stays, and cost of care, after discharge.~     Hypothesis 3: Compared with usual care, patients who receive the DCT intervention will have~     significantly lower hospital readmissions, shortened length of subsequent hospital stays and~     lower cost of care, at 30, 90, and 365 days of discharge.~      Leading the research team are a psychiatrist (Dr. IsHak - PI) and a hospitalist (Dr. Nuckols~     - Co-I) with an advanced and well-established track record of health services~     research/scholarship in the fields of depression, outcome measurement, and economic~     implications of improving the quality and safety of health care.~   "
80|NCT03056170|"~     tDCS is a technique emerging as a prospective therapy for neurologic, psychiatric and~     addictive disorders. Specifically, fronto-temporal tDCS, with anodal stimulation over the~     left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the left~     temporo-parietal junction (TPJ), has been reported to reduce treatment-resistant auditory~     hallucinations (AH), negative symptoms and insight of the illness in schizophrenia. However,~     despite an increasing use in clinical settings, tDCS suffers from limitations, especially~     regarding the strength and the duration of therapeutic effects.~      Some imaging reports suggest that tDCS effects are not restricted to the brain areas located~     under the electrodes, but spread through distributed cortical networks functionally~     connected with the targets and reach subcortical areas. Overall, these studies suggest that~     tDCS modulates functional connectivity within and across resting-state networks and brain~     activity. However, these effects are currently described at different levels depending on~     the imaging technique used. Moreover, the majority of studies have focused on motor cortex~     stimulation, while the specific effects of fronto-temporal tDCS are scarce. Finally, effects~     of the stimulation applied online are rarely inspected.~      According to the therapeutic effects of fronto-temporal tDCS on schizophrenia and the~     dopaminergic pathophysiological hypothesis of schizophrenia, the effect of fronto-temporal~     tDCS on dopaminergic transmission is of major interest. As the cortex is densely connected~     with basal ganglia areas, tDCS effects are probably capable to reach subcortical~     dopaminergic areas. Indeed, recent fMRI studies highlighted subcortical effects of tDCS~     applied at the cortical level including modulations of cortico-striatal and thalamo-cortical~     functional connectivity. In addition, some studies suggest that cortical stimulation by~     other approaches, such as transcranial magnetic stimulation (rTMS) modulates dopaminergic~     transmission. However, tDCS effects on dopaminergic transmission have been investigated only~     indirectly.~      Finally, information about biological effects of tDCS is scattered and creating a coherent~     ensemble is a mandatory and critical step to understand the mechanisms of action of tDCS.~      According to the hypothesis that fronto-temporal tDCS modulates brain activity, connectivity~     and dopaminergic transmission, the aim of this project is to reveal the combined~     neurobiological impact of an online single session of fronto-temporal tDCS in a unique~     experiment by developing a simultaneous multimodal imaging approach (PET-MRI). The online~     implementation of the stimulation will allow deciphering changes induced during and after~     stimulation. As a first step before investigating patients with schizophrenia, healthy~     subjects will be involved in the present study.~      The distributed changes will be explored at rest through:~        -  Spontaneous functional connectivity assessed by functional magnetic resonance imagery~          (fMRI).~        -  Brain activity assessed by cerebral blood flow quantitatively and directly measured by~          arterial spin labelling (ASL).~        -  Connectivity assessed by diffusion tensor imaging (DTI).~        -  Specific and localized dopaminergic transmission evaluated by positron emission~          tomography (PET) using dopaminergic D2 subtype receptor availability via~          [11C]raclopride binding.~      The pioneering aspects of the project are to use an innovative simultaneous multimodal~     imaging system, adopt the tDCS montage used in our validated therapeutic context and apply~     tDCS online. We expect that our unique approach will provide an imaging biomarker essential~     to improve our understanding of:~        1. the normal brain and further deficient mechanisms underlying schizophrenia as well as~          neurological disorders.~        2. neurobiological effects of tDCS in order to:~             -  Bring key element of the proof of concept of tDCS~             -  Optimize tDCS in a therapeutic context~             -  Suggest a marker of the therapeutic response~   "
81|NCT03056157|"~     The aim of this study is to determine the efficacy of Adaptive Disclosure for Moral Injury~     and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral~     Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL~     will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive~     Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting~     psychological and behavioral obstacles to occupational, relationship, and family~     functioning, as well as quality of life. PCT is a manualized evidenced-based PTSD treatment~     used in several large-scale PTSD trials. The primary end-point is psychosocial functioning~     (improvements in social, educational and occupational functions and improvements in quality~     of life). Secondary end-points include PTSD, depression, and shame and guilt. The~     investigators will also explore the impact of AD-MIL on anger and aggressive behaviors,~     suicidal ideation, and alcohol abuse.~   "
82|NCT03056144|"~     Spinal muscular atrophy (SMA) are one of the common physical disabilities in childhood. For~     SMA, progressive muscle weakness and early fatigue hamper the mobility of the sufferers.~     Osteopenia is common for this population group due to poor bone growth and muscle disuse. As~     a result, non-traumatic related fractures and bone pain are common. Recently, whole body~     vibration therapy (WBVT) has been proven to improve bone health and muscle function in~     healthy adults and post-menopausal women. Among the limited studies on the WBVT for children~     with muscular dystrophies, promising results have been shown on gross motor function,~     balance, and muscle strength and the WBVT appears to be safe for children with SMA.~      The present pilot study is designed to investigate if WBVT is safe and feasible for~     individuals with SMA and if WBVT can improve muscle function, functional abilities, postural~     control and bone mineral density in children with SMA. Convenience samples of 10 individuals~     with SMA type III will be recruited. The participants will receive the WBVT of 25 Hertz and~     a peak-to-peak amplitude of 4mm for a session of about 18 minutes, 3 days per week for 4~     weeks. Assessment will be performed at the baseline and the completion of the intervention~     to examine the muscle function, functional abilities, postural control and bone mineral~     density of the participants.~      It is anticipated that the outcomes of this pilot study for SMA may show if this~     intervention is safe, feasible and beneficial for children with SMA type III regarding to~     muscle function, functional abilities, postural control and bone mineral content and if~     there may be any related practical issues of this intervention to this population group. The~     outcomes also provide research evidence to clinicians if this intervention should be~     recommended to individuals of similar problems.~   "
111|NCT03055728|"~     The purpose of this study is to determine if the rapid antigen detection test for Group A~     streptococcal pharyngitis diagnosis might yield higher rates of false positive results in~     patients who have been treated for GAS pharyngitis within 28 days of the test.~   "
83|NCT03056131|"~     Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5~     worldwide). Individuals with TTH typically present pericraneal tenderness and an increased~     cervical muscle tone.~      The most common treatment in primary care consists mainly on analgesic medication. However,~     different techniques of manual therapy have been shown to be effective in the treatment of~     these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of~     tension type headache, but there is no scientific evidence that analyzes this effects.~      The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the~     usual conservative treatment has beneficial effects on different variables of the headache.~      The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity,~     frequency, duration of headache and cervical function in patients with tension type~     headache.~      A randomized controlled clinical trial has been designed to evaluate the effectiveness of~     diacutaneous fibrolysis technique compared to usual general practicioner care in patientes~     with tension type headache.~      The study protocol has been approved by the Clinical Research Ethics Committee from the~     Aragon Community and all patients provided written consent.~      Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group~     or a control group. Intervention group received three sessions of Diacutaneous Fibrolysis,~     while control group was advised to maintain their usual pharmacologic treatment. Pain~     intensity (VAS), frecuency, location, cervical range of motion, head forward position and~     pressure pain thresholds (PPTs) were measured at baseline, postintervention, and 1 month~     follow-up after treatment. The Spanish version of the HIT-6 Questionnaire was used to~     measure disability/function at baseline and follow-up.~   "
84|NCT03056118|"~     Investigators try to assess the safety of 6-months or 12-months maintenance of dual~     antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous~     coronary intervention using the Zotarolimus-eluting, Resolute Integrity™ stent (Medtronic~     Vascular Inc, Santa Rosa, CA) or the BioMatrix™ stent (Biosensors. Singapore).~   "
85|NCT03056105|"~     The purpose of this study was to examine how participation in a 1 month intensive Insight~     (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social~     affiliation, and inflammation, which are important for physical health, longevity, and~     behavior, and (b) to relate observed biological changes to baseline levels and changes in~     psychological traits, which may underlie improvements in personal adaptive functioning.~   "
86|NCT03056092|"~     Objective: To determine the association between baseline aqueous cytokine levels and~     treatment intervals for patients under a variable dosing regimen with intravitreal~     ranibizumab in patients with neovascular age-related macular degeneration (nAMD), macular~     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).~      Methods: A prospective, single-centre study will be performed containing 3 sub-studies~     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion~     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD,~     macular edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse~     than counting fingers, with macular pathologies causing any structural changes to the~     retina, have received anti-VEGF injections or photocoagulation therapy 6 months prior to~     study, intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or~     ocular inflammation in the study eye, use of systemic or topical anti-inflammatory or~     steroids, patients on dialysis for renal failure, allergy to the study drug or fluorescein,~     <18 years old, women who are pregnant. All patients will be treated with ranibizumab~     intravitreal injections on a variable dosing regimen: Patients with DME will be examined~     monthly and receive mandatory injection for the first three months (baseline, weeks 4 and~     8). Afterwards, they will continue to be seen monthly and the need for new injections will~     be decided upon the clinical findings at each visit. An anterior chamber (AC) tap will be~     done if an injection is required at the visit. Patients with nAMD and RVO will be examined~     monthly and receive mandatory injection for the first three months. From weeks 12 until 72~     (month 18), the visits will be scheduled at increasing 2-weeks intervals based on the~     stability of the ocular condition and response to treatment. At each visit, an injection and~     AC tap will be performed. The maximum interval in between injections is 12 weeks. If the~     disease becomes unstable, the interval in between injections is shortened and, once it~     stabilizes, the treatment frequency is extended again. In all patients, baseline aqueous~     humour specimens will be obtained prior to the first ranibizumab intravitreal injection and~     follow-up samples will be taken immediately prior to subsequent injections based on the~     treatment regimens for cytokine analysis in the end of the follow-up.~   "
87|NCT03056079|"~     Objective: To determine the association between baseline aqueous cytokine levels and~     treatment intervals for patients under a variable dosing regimen with intravitreal~     aflibercept in patients with neovascular age-related macular degeneration (nAMD), macular~     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).~      Methods: A prospective, single-centre study will be performed containing 3 sub-studies~     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion~     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD,~     macular edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse~     than counting fingers, with macular pathologies causing any structural changes to the~     retina, have received anti-VEGF injections or photocoagulation therapy 6 months prior to~     study, intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or~     ocular inflammation in the study eye, use of systemic or topical anti-inflammatory or~     steroids, patients on dialysis for renal failure, allergy to the study drug or fluorescein,~     <18 years old, women who are pregnant. All patients will be treated with aflibercept~     intravitreal injections on a variable dosing regimen: Patients with DME will be examined~     monthly and receive mandatory injection for the first three months (baseline, weeks 4 and~     8). Afterwards, they will continue to be seen monthly and the need for new injections will~     be decided upon the clinical findings at each visit. An anterior chamber (AC) tap will be~     done if an injection is required at the visit. Patients with nAMD and RVO will be examined~     monthly and receive mandatory injection for the first three months. From weeks 12 until 72~     (month 18), the visits will be scheduled at increasing 2-weeks intervals based on the~     stability of the ocular condition and response to treatment. At each visit, an injection and~     AC tap will be performed. The maximum interval in between injections is 12 weeks. If the~     disease becomes unstable, the interval in between injections is shortened and, once it~     stabilizes, the treatment frequency is extended again. In all patients, baseline aqueous~     humour specimens will be obtained prior to the first aflibercept intravitreal injection and~     follow-up samples will be taken immediately prior to subsequent injections based on the~     treatment regimens for cytokine analysis in the end of the follow-up.~   "
88|NCT03056066|"~     The purpose of this study is to assess the accuracy of FRC and airway resistance calculate~     values of Spircare device as compared to the conventional body plethysmograph in healthy~     adults and patients with obstructive and restrictive pulmonary diseases/disorders.~   "
89|NCT03056053|"~     The main study objective is to assess the content validity and the psychometric~     characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).~   "
90|NCT03056040|"~     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients~     with PNH who are clinically stable on eculizumab for at least 6 months~   "
91|NCT03056027|"~     Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will~     be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before~     and after surgery in order to rule out the potential impact of the surgical procedure on~     testicular arterial and venous blood flow~   "
92|NCT03056014|"~     Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces~     malformation rates in embryos of diabetic animals. However, human trials exploring the~     benefits of these antioxidant vitamins have produced unsatisfactory results in trials~     designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in~     pregnancies. The investigators hypothesize that more potent, and better-targeted~     antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be~     successful in preventing birth defects in the offspring of women with diabetes.~   "
93|NCT03056001|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of~     doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable~     soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study~     treatment.~   "
1170|NCT03041896|"~     To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2~     levels with the coflex® Interlaminar Technology or decompression with or without fusion.~   "
99|NCT03055923|"~     This Pilot study evaluates the use of a new device called Inflammacheck and whether it can~     consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also~     assess whether exhaled breath condensate hydrogen peroxide levels as measured by~     Inflammacheck can differentiate people with asthma and COPD from healthy individuals.~   "
100|NCT03055910|"~     The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry~     to analyze the use of fractional flow reserve (FFR) measurements in clinical practice in~     cardiac catheterization laboratories in Germany. The registry aims to collect the data of~     2000 patients who underwent FFR recordings for clinical reasons. The main outcome parameter~     is the frequency of coronary revascularization following FFR. Secondary outcome parameters~     include the distribution of quantitative FFR results in clinical practice, the influence of~     intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of~     complications as a result of FFR measurements, the average number of FFR wires needed per~     patient. Since the study will include a large number of patients who undergo i.c.~     administration of adenosine and a large number of patients who undergo i.v. administration~     of adenosine, it will be possible to analyze whether the route of adenosine administration~     is an independent predictor of the FFR result.~   "
101|NCT03055884|"~     The purpose of this study is to investigate whether it is possible to accelerate learning~     and improve associative memory performance in healthy subjects, by (1) applying transcranial~     Direct Current Stimulation (tDCS) during a verbal paired-associate learning task and by (2)~     optimizing the learning method with repeated retrieval practice.~   "
102|NCT03055871|"~     The purpose of this study is to examine physical activity habit formation in parents and if~     this can increase moderate to vigorous physical activity behavior in their children over six~     months.The Primary Research Question is:~      Does the habit formation condition result in increased moderate-vigorous intensity physical~     activity of the child compared to the control (education) and education + planning~     conditions at six months? Hypothesis: Child physical activity will be higher for the habit~     formation condition in comparison to the more standard physical activity education and~     planning conditions at six months.~   "
103|NCT03055845|"~     A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to~     investigate the safety, local tolerability and transformation of nucleus pulposus following~     intradiscal injection of STA363 or placebo in patients with discogenic low back pain.~      15 patients will participate in either of 3 dose groups, each comprising 5 patients:~        -  Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)~        -  Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)~        -  Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)~   "
104|NCT03055819|"~     The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a~     browlift for patients with age-related brow ptosis. It is a single arm, open label~     multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20~     subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used~     to confirm the device safety and efficacy and provide inputs to further refine the device~     design and procedure technique for future device iterations~   "
105|NCT03055806|"~     A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the~     effect of 3 different dose levels of IX 01 on IELT and patient-reported outcome in men with~     lifelong PE.~      Men with self-reported lifelong PE (ISSM definition) and in stable heterosexual relationship~     will undergo a 4-week run-in period during which they will be asked to attempt intercourse~     at least 4 times. Men with IELT ≤ 1 minute on at least 75% of attempts at intercourse during~     the no-treatment run-in period will be randomized for the double-blind phase of the study.~      In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours~     prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of~     8 times during the 8 week double-blind study treatment. The patient or partner will record~     the IELT on each occasion by use of a stopwatch.~   "
106|NCT03055793|"~     The greater efficacy of combination therapy led to the development of fixed combination~     devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable~     combinations of fluticasone-salmeterol, budesonide-formoterol).~      Fixed combinations are easier to use for patients, potentially increasing compliance, and~     ensure that the LABA always accompanied by glycocorticosteroeides1. From the available~     combinations of the combination of budesonide-formoterol can be used both in maintenance~     therapy and for the relief of symptoms due to the rapid onset of action of formoterol~     compared with salmeterol. Both components of budesonide-formoterol combination when~     administered on demand contribute to strengthening protection from severe exacerbations in~     patients receiving combination therapy for maintenance, and enable improvement of asthma~     control at relatively low doses of ICS.~   "
107|NCT03055780|"~     The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to~     detect functionally significant coronary stenosis.~   "
108|NCT03055767|"~     The purpose of the research is to examine the outcomes of pediatric patients receiving~     Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature~     on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric~     patients, specifically in the treatment of migraines.~   "
109|NCT03055754|"~     Bariatric surgery procedures have consistently been demonstrated to reduce long-term~     co-morbidities and mortality. Despite its benefits, weight regain is common, usually~     initiating around two years after the initial procedure, the underlying mechanism often~     being an enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass. Although~     a reduction in the anastomosis diameter has been reported in association with endoscopic~     argon plasma coagulation, to our knowledge this therapy has not been formally tested in a~     randomized controlled trial. the objective of this study is to conduct a randomized,~     parallel controlled trial comparing endoscopic argon plasma coagulation to reduce the~     enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass versus control with~     an initial diagnostic endoscopic followed by observation. The investigators hypothesize that~     the argon coagulation arm will achieve greater weight reduction, with a low incidence of~     adverse events.~   "
110|NCT03055741|"~     The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients~     with mild-moderate Alzheimer's disease treated with donepezil~   "
17958|NCT02822300|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
112|NCT03055715|"~     The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before~     initiation of radiotherapy and its changes during radiotherapy and to correlate them with~     retrospectively recorded patient data, as well as with prognostic and therapeutic outcome~     after definite radiotherapy of locally advanced NSCLC in stage UICC III.~   "
113|NCT03055702|"~     A randomized controlled trial of patients with type 2 diabetes mellitus with multiple~     appointments into short message service group and control group. The attendance rate of~     these two groups of patients will be compared.~   "
114|NCT03055689|"~     This trial will evaluate the efficacy in colon cleansing of a nurse-led educational~     telephone intervention 24-48 hours before a colonoscopy, in selected participants with a~     previous inadequate bowel preparation.~   "
115|NCT03055676|"~     The aim of this randomized prospective multicenter study is to demonstrate the hypothesis~     that early removal of drain can reduce the incidence of pancreatic fistula and~     intra-abdominal infection after pancreaticoduodenectomy , when compared with later removal~     of drain.~   "
116|NCT03055663|"~     During spinal anesthesia, sedation is performed using intravenous sedative for the patient's~     comfort and appropriate surgical environment. However, side effects of medications such as~     respiratory depression, hypotension, bradycardia and desaturation cannot be avoided.~     Recently, there have been developed a virtual reality experience equipment and a variety of~     virtual reality programs including visuo-haptic computer technology. There have been~     clinical studies that apply this technology to the pain medicine, sedation and medical~     education. However, no study has been reported for the purpose of replacing sedation during~     spinal anesthesia.~      Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality~     meditation program during spinal anesthesia for urologic surgery.~   "
117|NCT03055637|"~     Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus~     two-flap palatoplasty for cleft palate repair.~   "
118|NCT03055624|"~     Investigator-initiated study to evaluate the safety and efficacy of prostate artery~     embolization for the treatment lower urinary tract symptoms in patients with benign~     prostatic hyperplasia~   "
119|NCT03055611|"~     Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation~     factor products. The purpose of this non-interventional study is to describe the real-world~     usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia~     A and B.~   "
120|NCT03055598|"~     This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is~     the last stage of chronic kidney disease. Anemia is very common in ESRD patients and require~     erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not~     enough red blood cells in your body. ESAs work by helping the bone marrow to produce red~     blood cells. There are two ESAs licensed for the treatment of anemia of CKD in the Unites~     States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major~     adverse effects should be acknowledged, including an increased risk of death, thromboembolic~     complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To~     minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with~     adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is~     recommended.~      Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA~     usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce~     the body's absorption of phosphate. In a prior study, it was seen that some laboratory~     values, such as iron levels, changed positively in response to Auryxia. In this study we~     want to see if using Auryxia will cause a change in laboratory values and lower the use of~     ESAs in ESRD patients.~   "
121|NCT03055585|"~     This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi~     mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia~   "
122|NCT03055572|"~     Persons with a loss of sense of smell, who agree to participate in this study, will be~     assigned to one of three groups: two groups will have smell training and the third group~     will not do smell training. Participants assigned to one of the smell training groups will~     be asked to smell four different odors in rotation for five minutes two times per day, a~     total of 10 minutes of participation per day, for 12 weeks. One smell training group will be~     given odors made of fragrance oils to use for smell training. The other smell training group~     will be given odors made of essential oils to use. Participants in all groups will continue~     taking all medications and nasal rinses for sinusitis as prescribed by their doctor.~   "
123|NCT03055559|"~     The haemoglobin level of the patients with iron deficiency should be increased clinical~     relevant after 12 weeks treatment with GlobiFer Forte.~   "
124|NCT03055546|"~     The aim is to examine whether intranasal oxytocin will influence the individuals' emotion~     regulation ability and related neural mechanisms.~   "
125|NCT03055533|"~     Headsprout is a commercially available computer-based reading program that teaches children~     fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout~     reading intervention has been shown to be effective with children with various levels of~     reading skills, but it has not been rigorously tested in children with autism spectrum~     disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in~     a pilot sample of 18 children with ASD and reading delays to serve as a foundation for a~     larger, future randomized clinical trial (RCT).~      Eighteen participants will be included in the study and randomly assigned to one of two~     groups; the first group will immediately receive treatment with the Headsprout reading~     program and the second treatment group will receive treatment after 12 weeks. Treatment~     sessions will occur for one to two hours, two to four days a week, for twelve weeks. The~     participants who do not receive treatment immediately will be asked to come in for reading~     assessments periodically throughout their wait time.~   "
136|NCT03055390|"~     A case control trial Patients who meet the inclusion criteria were asked to participate in~     the study and a written consent was obtained from each patient after explaining thoroughly~     the nature and the scope of the study.~      Patients were divided into three equal groups:~      Group A: included 40 pregnant patients. They received two ml of normal saline intravenously~     as a placebo.~      Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml~     HBB+ one ml saline) intravenously.~      Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide~     intravenously (HBB).~   "
126|NCT03055520|"~     A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an~     errorless learning method for improvement of cognition in schizophrenia. Outpatients were~     included after signing an informed consent. The trial consisted of 48 sessions of arithmetic~     training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The~     patients were evaluated with a neuropsychological battery at baseline, after 6 months (end~     of intervention) and after 12 months after baseline. The Positive and Negative Syndrome~     Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline,~     after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the~     performance on three cognitive domains (attention, executive functions and working memory).~   "
127|NCT03055507|"~     Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the~     US, with about 250,000 cases performed annually. Currently, there is no consensus,~     evidence-based post-operative pain regimen; with the majority of practitioners opting for a~     combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs~     due to decreased platelet aggregation and the theoretical risk of increased post-operative~     bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following~     ESS. Additionally, there is a lack of information regarding the average narcotic requirement~     following ESS.~      The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in~     sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This~     investigation will help to gain understanding of current opioid use in post-op sinus~     patients and assess the safety and effectiveness of post-operative ibuprofen administration~     on pain. The investigators aim to quantify the average narcotic use following ESS, as well~     as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on~     pain scores and post-operative epistaxis. The investigators hypothesize that the use of~     ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with~     individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid~     use in the post-operative period. Additionally, the investigators hypothesize no increase in~     post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding~     events.~      In summary, this will be the first study to the investigators knowledge to examine the~     effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and~     epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the~     investigators will be equipped to design and perform the optimal prospective, randomized~     study evaluating the effect of NSAID in ESS during the post-operative period. The~     overarching goal of this investigation is to decrease opioid use in post-operative pain~     control following ESS.~   "
128|NCT03055494|"~     This study will provide a comparison of secukinumab to placebo with respect to skin~     inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and~     blood sample analyses.~   "
129|NCT03055481|"~     The aim of this trial is to show that the low irradiance level is not worse than the high~     irradiance level in the phototherapy for neonatal jaundice.~   "
130|NCT03055468|"~     Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About~     30% of DM patients suffer from Depression. Depression in DM patients is associated with~     adverse outcomes including poor medication adherence, poor glycaemic control, and early~     death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are~     high and staff shortages rife, peer support has been suggested as a means of delivering~     psychosocial care for persons with chronic illnesses in order to improve patient's outcomes.~     However, little has been done to examine the efficacy of peer support on clinical outcomes.~      Project aims: The main study objective will be developing a peer support model of depression~     care for patients with DM and testing its efficacy on clinical outcomes.~      Methods: This study will employ both qualitative and quantitative measures. First, the~     investigators will present the peer support model to health workers within the DM clinic,~     and ask them about the feasibility of using such a model for DM patients with depression.~     The investigators will then identify 10 DM patients with major depression and initiate them~     on antidepressants. Once the patients are in clinical remission, the investigators will~     interview them to assess their perceptions about the feasibility of using peer support for~     DM patients newly diagnosed with depression. The investigators will also interview health~     care workers and hospital administrators to assess their perception about using peer support~     within the clinics, and potential barriers that need to be addressed before implementation~     of the model.~      Based on the data from the qualitative interviews, the investigators will refine and adapt~     the peer support model, and then train 10 DM patients who have received antidepressants and~     are in clinical remission to deliver peer support to newly diagnosed patients with~     depression. Newly diagnosed depressed patients will be randomly assigned to receive either~     antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants~     will be followed for 48 weeks and assessed for, glycaemic control, depression severity,~     mental illness stigma, depression treatment uptake and adherence.~      Result: the investigators anticipate that the findings about the efficacy of peer support on~     DM and depression outcomes will be useful in generating data about effect sizes necessary~     for calculating a sample size for a cluster randomized trial (CRT).~   "
131|NCT03055455|"~     In critically ill children with severe sepsis, neurophysiologic derangements often proceed~     undetected and can lead to irreversible brain injury causing neurocognitive and behavioral~     deficits. The etiology of these impairments is unclear, however, it is likely that some of~     this neural injury is preventable. The overarching goal for this study is to show that acute~     acquired structural and microstructural brain injury occurs in critically ill children with~     severe sepsis, and that this injury is related to neuropsychological deficits and impaired~     cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within~     2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation~     of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood~     pressure with middle cerebral artery flow velocity measured by transcranial doppler~     ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will~     also participate in a neuropsychological evaluation 6 months after enrollment to evaluate~     multiple domains of behavior and cognition.~   "
132|NCT03055442|"~     Considering the importance assumed by follicular microenvironment for a proper oocyte~     development, this study is a prospective observational clinical trial which aims to evaluate~     whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and~     D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study~     includes egg donors and egg receiving couples participating in the oocyte donation program.~     MI/DCI is calculated in FF and related with blastocyst grade.~   "
133|NCT03055429|"~     The mission of corrections is to provide custody, control and care for incarcerated~     individuals. United States prisons are required by constitutional law to provide adequate~     care for growing numbers of older inmates who will likely spend their final days in prison.~     This Phase II project focuses on the correct users accessing correct learning strategies in~     the correct setting (i.e., interdisciplinary prison staff accessing high quality products~     designed to educate and lead practice change initiatives within the walls of prisons), by~     continuing research and development of a learning system that promotes an integrated systems~     approach to enhancing the care of the aged and dying in prisons.~   "
134|NCT03055416|"~     African American men are at risk of developing chronic disease partly due to low levels of~     regular physical activity. Studies have been effective in increasing physical activity~     levels in African American men; however for the health benefits of exercise to be maintained~     continued physical activity is necessary. The purpose of the current study is to develop a~     mobile phone application for African American men that will help them maintain their~     physical activity levels.~   "
135|NCT03055403|"~     This Phase I first-in-human is designed to evaluate the safety, tolerability and~     pharmacokinetics of single ascending doses of M201-A administered by single continuous~     intravenous injection in Healthy Japanese subjects.~   "
1196|NCT03041558|"~     This project will evaluate the implementation and efficacy of a domestic violence~     intervention module for parents receiving child welfare home visitation services.~   "
137|NCT03055377|"~     This is a 12-week randomized, placebo-controlled trial of N-acetylcysteine for cannabis use~     disorder (CUD) in youth (N=192). Participants will be randomized to double-blind NAC or PBO,~     yielding two equally-allocated treatment groups. All participants will receive brief weekly~     cannabis cessation counseling and medication management. The primary efficacy outcome will~     be the proportion of negative urine cannabinoid tests during the 12-week active treatment,~     compared between groups.~   "
138|NCT03055364|"~     In this study, the investigators propose to evaluate cognitive function and determine the~     feasibility of neurocognitive assessment using a select CogState test battery in patients~     with primary intracranial malignancies receiving photon- or proton-based cranial irradiation~     with curative intent. The investigators will use the CogState software to quantify changes~     in verbal learning, memory, and executive function over the initial months and years~     following radiation treatment. Cognitive changes and temporal patterns of function will be~     compared to baseline performance for each patient. Data regarding cognitive function,~     fatigue, quality of life, and standard patient reported outcomes will be collected to~     characterize the daily impact of treatment. In addition, observed outcomes will be~     correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.~   "
139|NCT03055351|"~     Stop&Go is an intervention program aimed at promoting a healthy and physically active~     lifestyle for patients requiring inpatient detoxification treatment. The program includes~     two different phases. Phase I is aimed at understanding the variables related with adherence~     to healthy lifestyle interventions. Phase II will use the knowledge obtained in Phase I to~     develop and evaluate an intervention based on Self-determination theory to promote healthy~     and physically active lifestyles for patients admitted to an inpatient detoxification~     centre. The Stop&Go intervention is hypothesized to help patients move towards a healthy~     lifestyle and thus, may bring about changes in patients' (1) knowledge acquired, (2)~     indicators of healthy habits (e.g., exercise motivation) and (3) psychological well-being~     and ill-being.~   "
140|NCT03055338|"~     This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind~     trial of MK-8189 compared with placebo, using Risperidone as an active control. The~     participants will be adult subjects experiencing an acute episode of schizophrenia,~     according to the criteria specified in the Diagnostic and Statistical Manual of Mental~     Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site~     visits for each participant. The study will consist of a Screening/tapering period (up to~     one week long), a 4-week treatment period, and a 14-day follow-up period. The primary~     objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and~     tolerability during treatment and post-treatment follow-up. The secondary objective will be~     to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189~     is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the~     mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score~     after 4 weeks of treatment.~   "
141|NCT03055325|"~     The aim is to map the inflammatory response after surgery and further investigate the~     mechanisms by which inflammation is regulated. The inflammatory cascade is pivotal in~     protecting organisms against invading pathogens and in enabling healing of damaged tissues,~     yet the cascade itself may be harmful to the organism when excessive (e g septic chock).~      The increased immune-reactivity after trauma, such as surgery, is furthermore associated~     with post-operative declines in memory and learning capacity, a condition likely related to~     the notion of sickness behavior. The effects on the brain after surgery and the associated~     neuro-immune crosstalk will now be investigated with focus on changes in immune reactivity~     in peripheral blood after surgery.~   "
142|NCT03055312|"~     Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of~     Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative~     breast~   "
143|NCT03055299|"~     The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility,~     tolerability and adherence of this novel video-based intra-dialytic chair exercise program~     for hemodialysis patients over 3 months.~   "
144|NCT03055286|"~     This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess~     safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C~     in subjects with relapsed or refractory AML. Based on the poor prognosis of~     relapsed/refractory AML, exploration of alternative doses and regimens will be evaluated and~     approved by a Safety Review Committee (SRC).~   "
145|NCT03055273|"~     This research is being done to find out the best ways to help people with end stage kidney~     disease take care of their daily lives and improve their social functioning.~      Investigators want to learn whether services in the Community Aging in Place, Advancing~     Better Living for Elders (CAPABLE) study such as help with medications, muscle~     strengthening, balance training, pain management, changes to houses and improved social~     support can be tailored to fit the needs of older adults with kidney disease to help improve~     their ability to balance, walk, and take care of themselves.~      People aged 60 years and older who have end stage kidney disease and have been receiving~     dialyses for at least 6 months, may join.~   "
146|NCT03055260|"~     The particpant will complete baseline testing by measuring subjects' quadriceps muscle~     thickness (cm) via ultrasound technology, as well as have them complete a one repetition~     maximum (1RM) test on the leg press machine and an isometric knee extension using a~     dynamometer - strength measures will be calculated for both right and left legs. After~     baseline testing, subjects will complete 6 weeks of the testing protocol that will consist~     of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a~     cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that~     does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will~     take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session.~     After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be~     re-tested and compared to the initial measurements.~   "
147|NCT03055247|"~     This is a phase II exploratory study conducted to evaluate the safety and efficacy of the~     combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients~     affected by X-CGD.~   "
566|NCT03049774|"~     The aim of this retrospective study is to review and describe the safety and the efficacy of~     recombinant human interleukin-11 (I) i (Baijieyi), using information already recorded in 20~     medical records, The time periods include May 8th of 2008 to december 31st of 2016.~   "
148|NCT03055234|"~     This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind,~     placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening)~     study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects~     will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study.~     Subjects will be permitted to enter a 48-week open-label extension period if they experience~     a PH clinical worsening event.~   "
149|NCT03055221|"~     This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated~     Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study~     RIV-PH-402 were eligible to enroll.~   "
150|NCT03055208|"~     Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free~     survival time after addition of an early gamma knife boost to areas of residual tumor to~     standard-of-care (surgery, chemo-radiotherapy, chemotherapy).~   "
151|NCT03055195|"~     Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on~     Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment,~     activation, and survival of eosinophils; thereby reducing the production and survival of~     eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study~     will investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous~     [SC] administered every 4 weeks) compared with placebo in adult subjects with moderate to~     severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or~     mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4~     weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16~     weeks with the last dose of study treatment at Week 12) and follow-up period of up to~     4-week. The total duration of subject participation will be approximately 26 weeks. (Note:~     For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and~     Screening period may last up to 20 weeks and total duration of participation in the study~     may be up to 40 weeks).~   "
152|NCT03055182|"~     The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and~     healthy people during an original and standardized isokinetic protocol.~      The aim of this study is to determine a potential alteration of muscular aerobic metabolism~     in low back pain patients, in order to establish the underlying cause of pain and muscular~     fatigability characterizing low back pain patients. Then, the aim is to determine if~     functional rehabilitation program can improve it.~      the unit of care have access to metabolic adaptations in measuring the muscular oxygenation~     and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.~   "
153|NCT03055169|"~     This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of~     TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay~   "
154|NCT03055156|"~     The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e.,~     airweave®) on sleep and sleep-related symptoms.~      The study will compare effects of use of high rebound mattress toppers versus use of low~     rebound mattress toppers on sleep and sleep related symptoms and core body temperature~     during diagnostic sleep studies.~   "
155|NCT03055143|"~     This was a randomized, multi centre, open label, two treatment, two period, two sequence,~     single dose, crossover study, with at least 28 days washout between doses, conducted under~     fed (normal breakfast) conditions.~   "
156|NCT03055130|"~     The associations between female inflammatory bowel disease (IBD) patients and human~     papilloma virus (HPV) infection and cervical neoplasia (dysplasia or cancer) were unclear.~     Especially there was no data for Chinese IBD population. So we investigated the incidence~     and risk factors of HPV infection and cervical neoplasia (dysplasia or cancer) in female IBD~     patient.~   "
157|NCT03055117|"~     Degenerative shoulder disorders are frequent in the Danish population and often cause~     disability and sick leave. After hospital discharge patients are often referred to~     physiotherapy rehabilitation as part of the treatment, and it is often assumed that~     one-on-one sessions will yield better results than group-based sessions, because individual~     needs can be better meet and targeted~      The project aims to evaluate the effect and cost-effectiveness of group- based exercise~     rehabilitation as compared to individual exercise rehabilitation in patients with~     degenerative shoulder disorders.~   "
158|NCT03055104|"~     Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of~     micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia~     nervosa. The refeeding phase of these high-risk patients bears a further threat to health~     and potentially fatal complications (such as refeeding syndrome, infection and severe~     arrhythmia). The objective of this study is to investigate complications due to refeeding of~     patients with severe malnutrition, as well as their mortality rate, establish and modify the~     guideline for management of severe malnutrition in Peking University Third Hospital.~   "
159|NCT03055091|"~     This is a randomized controlled trial of regular daily use of xylitol (or birch sugar), a~     natural sweetener that has antimicrobial properties, for the prevention of acute otitis~     media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries~     (the two secondary outcomes) in preschool aged children. This trial will be conducted~     through the TARGet Kids! research network.~   "
160|NCT03055078|"~     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem~     Cells transplantation in aplastic anemia.~   "
161|NCT03055065|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
162|NCT03055052|"~     This study evaluates the effects of infant formula with higher protein level and improved~     fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will~     receive a standard infant formula, while the other half will receive a infant formula with a~     higher protein level and improved fat blend.~   "
176|NCT03054870|"~     Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to~     Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas~     compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory~     distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per~     medical needs followed by Technegas ventilation imaging per study protocol.~   "
20222|NCT02792504|"~     To evaluate safety and efficacy of CE/BZA in real practice in Korea~   "
163|NCT03055039|"~     The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy.~     During the delivery the baby is exposed to multiple exterior factors and he is capable to~     memorize the pain .Recent epidemiologic studies showed that the coverage of pain was~     insuffcient and also an increase of analgesic means. Normally the pain coverage have to be~     managed and group every painful gesture. In fact all these recommandations are not followed~     by medical team.~      The aim of the study is to evaluate the prevalence of this type of pain as to set up an~     adequate coverage.~   "
164|NCT03055026|"~     Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery~     for colorectal cancer: a randomized, double blind, placebo-controlled study.~   "
165|NCT03055013|"~     This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of~     a kidney) with or without nivolumab in treating patients with kidney cancer that is limited~     to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may~     interfere with the ability of tumor cells to grow and spread. Giving nivolumab before~     nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to~     be removed, and after nephrectomy to increase survival. It is not yet known whether~     nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with~     kidney cancer.~   "
166|NCT03055000|"~     Mosquito-borne diseases continue to cause significant morbidity and mortality worldwide~     despite on-going control efforts. In 2015, there were >200 million cases of malaria~     worldwide, causing nearly half a million deaths, with most of the deaths occurring among~     children under the age of 5 years 1. Mosquitos also transmit arboviruses, including dengue,~     yellow fever, West Nile virus, chikungunya, Rift Valley fever, Japanese encephalitis, and~     Zika virus. The current new outbreak of Zika virus in Central and South America, as well as~     the Caribbean, serves as a reminder of how quickly these viruses can spread and how~     difficult they can be to control.~      In this protocol we plan to perform a phase I study of a novel universal mosquito-borne~     disease vaccine. Through modulation of the immune system after a mosquito feeding, this~     vaccine targets the vector saliva and may provide prophylaxis against multiple arboviral and~     protozoal diseases. In addition the vaccine potentially leads to a reduced mosquito lifespan~     after feeding therefore also reducing transmission of these diseases.~      In this protocol we hope to demonstrate the safety of this vaccine similar to SEEK s other~     peptide based vaccines Flu-v and HIV-v that have been found to have very good safety~     profiles in previous phase I trials. We also hope to demonstrate immunomodulation after a~     controlled clean Aedes aegypti mosquito feeding to demonstrate proof of concept efficacy of~     the vaccine. With the current rise of Zika in the Americas and the threat of local mosquito~     transmission in the U.S. and the rest of the world, a successful universal mosquito-borne~     disease vaccine offers the benefit of targeting this emerging disease as well as the many~     established infections such as dengue and malaria that make dealing with this newly emerging~     epidemic a challenge.~   "
167|NCT03054987|"~     The purpose of this study is to compare the need to use mechanical lithotripsy between~     patients undergoing POC-LL and EBS for removal of difficult bile duct stones~   "
168|NCT03054974|"~     The purpose of this study is to determine the effectiveness,safety and Input-output ratio of~     chinese traditional treatment in spasm after stroke,both in massage and herbal medicine~     bathing.~   "
169|NCT03054961|"~     The purpose of this pilot study is to describe the relationship of regional cerebral~     oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity~     in the periictal period in children with epilepsy.~   "
170|NCT03054948|"~     Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US.~     Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be~     associated with a number of complications including inflammation, abnormal liver function~     tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the~     FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain~     triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to~     omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of~     intolerance to soybean oil IVFE. This study is designed to investigate the impact of~     SMOFlipid in prolonged use.~   "
171|NCT03054935|"~     The aim of this study is to investigate the effect disease activity on resting energy~     expenditure (REE), body composition, inflammatory markers, food intake and quality of life~     in subjects affected by Crohn's Disease (CD)~   "
172|NCT03054922|"~     During major surgical procedures, intravascular volume is maintained with the administration~     of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All~     three of these fluids are in common clinical use for this purpose. As large volumes of NS~     may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical~     decision making when resuscitative efforts are guided by acid-base status on routine~     arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in~     acid-base and electrolyte (sodium, potassium, calcium) status with the use of various~     isotonic fluids for intraoperative resuscitation.~   "
173|NCT03054909|"~     This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex~     (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy~     for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.~   "
174|NCT03054896|"~     This research study is evaluating the combination of a study drug, venetoclax, and a~     standard chemotherapy regimen, EPOCH-R, as a possible treatment for Richter's Syndrome.~      The drugs involved in this study are:~        -  Venetoclax~        -  EPOCH-R:~        -  Etoposide~        -  Prednisone~        -  Vincristine Sulfate (Oncovin)~        -  Cyclophosphamide~        -  Doxorubicin Hydrochloride (Hydroxydaunomycin)~        -  Rituximab~   "
175|NCT03054883|"~     This is an observational study aimed to analyze the effectiveness of treatment of patients~     with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem~     cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab,~     cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin):~     R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the~     previously published data in the younger patients, which demonstrated improved outcome after~     implementation of Ara-C into induction.~   "
567|NCT03049761|"~     Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different~     Pressure Settings~   "
177|NCT03054857|"~     Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing~     postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use~     cardiopulmonary bypass machine (CPB).~      Materials and Methods: This study was double-blinded, randomized controlled trial. Patients~     scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups,~     dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless~     test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined~     as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for~     IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1),~     arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of~     POCD and the secondary outcomes were inflammatory response, other postoperative~     complications, ICU and hospital stay.~   "
178|NCT03054844|"~     Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population~     for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and~     distressing procedures, such as laceration repairs. Intranasal midazolam is both effective~     and safe in children. However, due to the acidic nature of midazolam, there is a burning~     sensation that is associated with the intranasal administration of midazolam. The use of IN~     lidocaine has been shown to decrease the pain associated with the administration of IN~     midazolam and other acidic solutions. The IN lidocaine can be given as a premedication~     (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then~     followed by the administration of the IN midazolam. Lidocaine can also be given concurrently~     with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined~     mixture administered. Both methods have been shown to be effective in decreasing the pain~     associated with the intranasal administration of acidic solutions, such as midazolam,~     although the PREMIX method could have the advantage of requiring less number of sprays, and~     be tolerated better by children. Although both methods have been shown to work, it is not~     known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and~     distress associated with administering IN midazolam. Therefore, the investigators aim to~     determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to~     decrease the pain and distress associated with the administration of IN midazolam in~     children.~   "
179|NCT03054831|"~     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of~     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely~     used in adults and children to relieve post-operative pain. However, its pharmacokinetics~     (what it does in the body) and pharmacodynamics (how it works) have not been well~     established in children. Some children, because of their specific genetic make-up, may~     metabolize the drug more quickly and therefore may be at risk for more side effects in the~     commonly prescribed dose. The investigators would like to find out more about how general~     anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In~     order to study these aspects, the investigators would like to give oxycodone to surgical~     patients (group one will receive oxycodone at the beginning of GA and group two will receive~     oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic~     activity and also perform a specific genetic analysis.~   "
180|NCT03054818|"~     This is a post-marketing drug safety monitoring study in a prospective manner, and data~     collection will be performed in a registration-follow-up manner. Safety information about~     patients who have received intravitreal injection of Conbercept Ophthalmic Injection in~     medical institutions involved in the study during research will be actively monitored~     without intervening in diagnosis and treatment. All patients enrolled will be followed up~     for one year.~   "
181|NCT03054805|"~     To compare the differences of fecal microflora between constipated and non-constipated~     healthy children, and evaluate the efficacy of probiotics in reducing symptoms of~     constipation and the influence of intestinal microflora in children with functional~     constipation.~   "
182|NCT03054792|"~     This study will test the feasibility of using novel/existing imaging technologies focused on~     hypoxia measurements to determine response to therapy in pediatric soft tissue sarcomas as~     a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen~     Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, Magnetic Resonance Spectroscopy (MRS)~     and 18F-FAZA PET-MRI with that of conventional MRI to detect measurement changes between the~     start and completion of neoadjuvant therapy (response to therapy) in children and~     adolescents (7-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use~     results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic~     schemes to patients on a personalized basis.~   "
183|NCT03054779|"~     Building on the findings from the investigators previous study, COMIT I, the purpose of the~     COMIT II study is to supplement the DEXA measurement of body composition with a~     supplementary DEXA measurement of visceral adipose tissue and to specifically target the~     impact of oleic acid consumption on body composition as the primary objective. COMIT II also~     will include analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate~     the mechanisms by which canola oil may be modifying body composition, measurement of~     endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and~     genetic analyses.~   "
184|NCT03054766|"~     To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal~     injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long~     term.~   "
185|NCT03054753|"~     The postoperative shoulder rehabilitation in an abduction brace after rotator cuff~     reconstruction of the shoulder is crucial for a successful healing of the reconstruction.~      In this study we want to analyse the abduction brace-wearing time using a electronic sensor,~     which is implanted in the abduction brace. The patient´s will be informed about the sensor~     after completion of the abduction brace rehabilitation 6 weeks postoperatively.~   "
186|NCT03054740|"~     The primary purpose of this study is to determine if by offering a vapocoolant (cold spray)~     to hospital outpatients prior to an intravenous catheter (IV) insertion will increase~     patient satisfaction of IV insertion as well as determine if pain of insertion is decreased.~   "
233|NCT03054116|"~     In a prospective, observational study the investigators compared resistance values measured~     using the airway perturbation device (APD) to impulse oscillometry and spirometry. The~     investigators also created reference equations for normal APD resistance ranges using the~     data from clinically normal volunteers.~   "
187|NCT03054727|"~     Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein~     thrombosis (DVT). In the absence of curative treatment of established PTS, its management is~     based on the prevention of its occurrence thanks to anticoagulants and compression~     stockings.~      So far, predictors of disabling PTS are unknown precluding from optimally selecting patients~     for invasive (early thrombus removal) or innovative/expensive treatments. In addition,~     little is known on the incidence of PTS in the very long-term.~      Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event,~     Primary objective: incidence and severity of PTS after a lower limb DVT.~      Main Secondary objectives:~        1. Incidence and severity of PTS according to VTE initial presentation (isolated distal~          DVT, isolated proximal DVT, PE + DVT).~        2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12~          years) of patients recruited in the large, multicentre, prospective, observational~          OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests~          (Clinical Trials NCT00670540).~      All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients~     without any history of VTE after the 3 years of follow-up) will first benefit from a~     phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a~     selection of controls will undergo a clinical follow-up visit with clinical and Compleat~     Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of~     life.~      Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of~     usual treatment. Better selecting patients eligible for invasive/innovative/expensive~     preventative procedures.~   "
188|NCT03054714|"~     Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed~     replacement, versus exchange over a guidewire to treat catheter related blood stream~     infection~   "
189|NCT03054701|"~     Patellofemoral pain (PFP) is highly prevalent in both adolescent and adult populations and~     as much as 91% of those affected experience ongoing knee pain for up to 20 years after the~     initial diagnosis.~      Exercise-based treatment focusing on strengthening the muscles around the hip and knee is~     usually effective when treating patient with PFP. However, this approach has proven~     ineffective in a subgroup of females who have suffered from PFP for multiple years.~      This group was found to have a significantly lower tolerance for pressure stimuli compared~     to healthy controls. This indicating that central mechanisms within the nervous system~     rather than the problem being the knee itself.~      Exercising a non-painful muscle distant to a painful part of the body has previously been~     effective in deceasing pain in affected area. This mechanism has been investigated in~     patients with long-standing musculoskeletal pain as well as healthy populations.~      Related research has suggested that a possible link between patients perception of painful~     stimuli an the pain-reducing effect of exercise exists. As such, patients witch experienced~     a pain reducing effect of exercise was found to be able to tolerate more pain than before~     the intervention.~      The aim of this study is to assess if exercising a distant non-painful muscle around the hip~     has a larger acute pain-reducing effect on knee pain compared to knee specific exercises in~     female patients with long-standing PFP.~   "
190|NCT03054688|"~     Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.~   "
191|NCT03054675|"~     Aim of this study was to prospectively investigate the correlation between postoperative~     spirometry values and pulmonary complications after anatomic lung resections. In addition,~     the investigators compared postoperative pulmonary function changes between open and~     minimally invasive approaches.~   "
192|NCT03054662|"~     This study aims to make an inventory of the condition and care of patients with haemophilia~     and carriers for haemophilia in Ivory Coast and to promote the use non substitutive~     strategies that are not costly and available in Ivory Coast, to improve the management of~     haemophilia in this country. The purpose of this project is to evaluate the extent to which~     the active promotion of these various measures will improve the care of patients with~     haemophilia and carriers in Ivory Coast.~   "
193|NCT03054636|"~     The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data~     from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information~     on device performance in a real-world setting.~   "
194|NCT03054623|"~     Our study seeks to define the effect of each component of the distal revascularization~     interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with~     ischemic steal, and to determine whether the interval ligation component of the DRIL~     procedure is necessary or not.~   "
195|NCT03054610|"~     Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in~     people 40 years of age or older, overweight, sedentary or with intense physical activity. It~     is caused by the over-stretching of the plantar fascia, which is a band of connective tissue~     that extends to the base of the phalanges. This produces micro-tears more commonly in its~     origin in the medial tuberosity of the calcaneus which causes an inflammatory process and~     pain. This pain usually occurs when the person gets up in the morning after sleeping or~     after sitting for a long time. That is when the fascia is stretched after being in a~     contraction position.~      There are a great variety of treatments for this pathology, of these, one of the most common~     is the use of intralesional steroids, which a weighing that reduces symptomatology in many~     cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar~     fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are~     extracorporeal shock waves, application of platelet-rich plasma and application of botulinum~     toxin A intralesional. All of them are accompanied by insoles, night splints and stretching~     exercises of the Achilles tendon and the plantar fascia.~      Recent studies have shown that the application of botulinum toxin A intralesional in~     patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both~     intensity and presentation time. Decreased inflammation of the plantar fascia has also been~     demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is~     applied regularly in the muscles to block the release of acetylcholine in the neuromuscular~     plaque and obtain its relaxation and not directly in the pain points. We believe that the~     botulinum toxin can be applied intralesional currently, since there is information that the~     toxin has analgesic and anti-inflammatory effect and not just muscle relaxation.~      The aim of our work demonstrate that the use of botulinum toxin A and intralesional~     stretching exercises is superior to intralesional steroids and stretching trying to~     establish a safer and less painful therapy avoiding complications prior to the application~     of steroid application.~   "
196|NCT03054597|"~     Children in the United States watch an average of twenty-eight hours of television and play~     around thirteen hours of video games per week. The objective of this experiment was to see~     if a specific eye exercises could strengthen the eye muscles and improve the peripheral~     vision range of children and adults.~   "
494|NCT03050723|"~     In this study, eligible patients with the medical indications (facial lipoatrophy,~     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®~     FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the~     treatment. A touch-up treatment may be done 2 weeks after the treatment.~   "
31155|NCT02649296|"~     The purpose is to find out the effect of Skanlab at knee arthrosis.~   "
197|NCT03054584|"~     The objective of this protocol is to further elucidate the genetic mutations that drive~     melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole~     genome, whole exome, or targeted sequencing of de-identified specimens.~      Herein, we plan to isolate DNA from de-identified skin biopsy specimens and blood samples:~        1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the~          tissue will be submitted for routine diagnostic dermatopathology and investigational~          histomorphologic and immunohistochemical analysis.~        2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a~          normal control when analyzing sequencing data to identify somatic mutations in lesional~          tissue.~   "
198|NCT03054571|"~     This investigation seeks to build upon existing evidence that a relationship exists between~     body mass and timing and the number of erupted teeth.~   "
199|NCT03054558|"~     Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living~     babies who had performed all investigations for recurrent miscarriage (RM) including :~     laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy~     and all results were free,will be scheduled for three dimensional trans-vaginal ultrasound~     (3D TVS) in the midluteal phase for measuring the impedance of uterine artery blood flow( by~     two dimensional Power Doppler TVS).Also by using 3D power Doppler the sub-endometrial blood~     flow will be assessed. In addition to the thickness of Junctional Zone (JZ) by using coronal~     view of 3 D TVS. To be compared with patients who had at least one full term living baby~     through normal vaginal delivery with no history of early pregnancy loss.~   "
200|NCT03054545|"~     This study is to evaluate the efficacy and safety of a novel chemical synthetic agent~     iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one~     failed immunosuppressive treatment and suffer active nephritis at the screening stage. The~     study period is 52 week. All the subject will receive therapy of iguratimod combined with~     steroids.~   "
201|NCT03054532|"~     This is a multi-center, open-label, phase II study of durvalumab in combination with~     lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will~     employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance~     level) of 5%. Stage 1 will involve 8 patients and will require at least 2 patients to~     achieve the primary end point of overall response in order to proceed onto to stage 2, which~     will have a target enrolment of 14 patients.~   "
202|NCT03054519|"~     The PERMET trial will determine whether metformin daily for six months improves walking~     performance in individuals with peripheral artery disease compared to placebo.~   "
203|NCT03054506|"~     Constipation is a common gastrointestinal motility disorder that is often chronic,~     negatively affects patients' daily lives. Constipation occurs when bowel movements become~     difficult or less frequent.This study is being done to study the effectiveness of the~     hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo~     (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic~     constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).~   "
204|NCT03054493|"~     1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged~          3-8 years old in Giza Governorate.~        2. Assessment of factors associated with NNSH.~   "
205|NCT03054480|"~     Because of the limiting data about an efficacy and safety of fractional radiofrequency for~     the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis~     Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and~     intradermal Botulinum toxin type A injection for the treatment of primary axillary~     hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch~     test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's~     satisfaction and their quality of life by Dermatology Life Quality Index and side effect~     between the groups.~   "
206|NCT03054467|"~     The aim of the present study is to compare the effects of CCB and CCB+ high dose of statin~     therapy on the symptoms, function, and quality of life assessed by validated angina-specific~     questionnaire (Short-form Seattle Angina Questionnaire (SAQ-7)), endothelial function as~     measured by FMD of the brachial artery, endothelial progenitor cells (EPC) and coronary flow~     reserve (CFR) in patients with VSA.~   "
207|NCT03054454|"~     Observational studies clearly show that people with diabetes and end-stage kidney failure~     have an increased risk of foot ulceration and leg amputation. However, there is very little~     evidence on addressing this problem.~      Diabetes foot care teams have been shown to reduce hospital admissions, length of stay and~     leg amputation in people with diabetes. Since their introduction at The James Cook~     University Hospital (JCUH) major diabetes-related leg amputation rates have fallen by 86~     percent (1995 to 2010).~      People with diabetes and end-stage kidney failure require haemodialysis (blood cleaning) 3~     times per week for several hours each time. This time commitment makes it difficult to~     attend other clinical appointments. An audit at JCUH shows that this population fails to~     attend the normal diabetes foot services.~      This project aims to reduce the incidence of foot disease in people with diabetes and~     end-stage kidney failure on dialysis. The investigators will set up a podiatry-led~     intervention within the dialysis unit to prevent and promptly treat foot disease in this~     population. This will involve foot risk assessment, risk reduction and treatment during~     dialysis. The intervention will involve diabetes consultants, podiatrists, vascular and~     orthopaedic surgeons . In this way the investigators hope to reduce leg amputation, hospital~     admission, procedures to unblock arteries and death in this high risk group.~      The study will run in the dialysis unit at JCUH. Patients will be divided into two groups:~     those attending for dialysis on a Monday, Wednesday and Friday will form the treatment group~     and those attending on a Tuesday, Thursday and Saturday will continue to be managed as at~     present. The investigators will collect data from patient health care records looking in~     particular at leg amputations, hospital admissions due to foot problems, foot surgery and~     operations to unblock arteries.~   "
208|NCT03054441|"~     In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could~     overcome the limitation of many outcome measures in which scores are dependent on the~     experience and training of the therapist. The main aim of this study was to determine the~     validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during~     the Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged~     5-19 years, compared to age-matched typically developing subjects (TD).~   "
209|NCT03054428|"~     To demonstrate the efficacy of dupilumab as a monotherapy in patients ≥12 years to <18 years~     of age with moderate-to-severe atopic dermatitis (AD)~   "
413|NCT03051776|"~     Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current~     therapies have modest results for this condition. Compression garments (CG) prevent the~     worsening of lymphedema and even improve it, during periods between treatments of physical~     therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence~     backs it. The aim of this study is to compare the reduction of lymphedema volume with both~     therapies.~   "
210|NCT03054415|"~     This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in~     healthy subjects.~      The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells.~     There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB~     together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut~     functions. The characteristics and the phenotype of the ENS also change according to age and~     environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal~     data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to~     assess abnormality of these items in patients with neurological disease including Spina~     Bifida.~   "
211|NCT03054402|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845~     using a placebo controlled, randomized, single center design.~   "
212|NCT03054389|"~     The purpose of this study is to seek to understand the patient's perspective around deciding~     to participate in a clinical trial for a Hemophilia therapy~   "
213|NCT03054376|"~     The study includes healthy young habitually active subjects. All subjects are subjected to~     two weeks of immobilization of one leg followed by four weeks of training of both legs. The~     subjects are randomized to either one-leg training of the non-immobilized leg during the~     two-week immobilization period or to no training of the non-immobilized leg during the~     immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis~     and apoptosis, muscle metabolic markers, vascular function, vascular proteins and~     performance.~   "
214|NCT03054363|"~     This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug~     combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib~     and aromatase inhibitor letrozole) as a first or second line of therapy in patients with~     metastatic hormone receptor positive and HER2-positive breast cancer.~   "
215|NCT03054350|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to~     assess the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in~     Japanese subjects with anemia secondary to DD-CKD.~   "
216|NCT03054337|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to~     assess the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in~     Japanese subjects with anemia secondary to NDD-CKD.~   "
217|NCT03054324|"~     Coronary fraction flow reserve (FFR), the ratio of the mean coronary pressure distal to a~     coronary stenosis to the mean aortic pressure during maximal coronary blood flow~     (hyperemia), defines the hemodynamic significance of coronary artery narrowing. Noninvasive~     assessment of FFR via a combination of computational fluid dynamics (CFD) and coronary CT~     angiography CCTA (the so-called FFRCT) has potential. Coronary computed tomographic~     angiography is a noninvasive test for diagnosis of anatomic coronary stenosis (i.e.,~     narrowing of a blood vessel). A new analytical model of FFR from the general Bernoulli~     equation (conservation of energy) (FFRB) is simple and has potential. A collaborator group~     has recently developed a new analytical model to quantify pressure drop, and hence FFR,~     based on lesion dimensions (i.e., the cross-section area along the lesion and the length of~     lesion) and coronary flow, with no empirical parameters. The investigators hypothesize that~     this new model will allow quantification of FFR (FFRB) in a cohort of human patients with~     intermediate coronary stenosis. The study will compare FFRB with invasive FFR measurements~     from invasive coronary angiography (ICAG).~   "
218|NCT03054311|"~     Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to~     get the most out of life. The intervention is based on an American model of health promotion~     called Lifestyle Redesign. This was found to be highly effective in enhancing the physical~     and mental health, occupational functioning and life satisfaction of community living older~     adults in Los Angeles, USA.~      Weekly group meetings provide older people with the space, time and opportunity to share~     their experiences. Through a process of peer exchange and guidance, participants have the~     opportunity to reflect upon the range of activities that they engage with. They are then~     helped to begin to understand how these activities might impact on their health and~     well-being. However this approach alone cannot meet the complex needs of individual older~     people, and their specific and personal concerns. In recognition of this, the programme also~     includes monthly individual sessions with one of the group facilitators. The older person in~     partnership with the facilitator identifies a tailored programme to meet their individual~     needs, including the means by which they might work towards their personal goals. The~     individual programme is updated and refreshed in subsequent meetings over the months.~      During 2004/5 researchers at Sheffield Hallam University in partnership with other~     researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility~     of delivering this intervention to older people living in the UK. The project was funded~     through the Sheffield Health and Social Research Consortium. The summary below is an account~     of the process and outcomes of delivering a Lifestyle Matters programme to two groups of~     community living older people during 2004/5.~   "
219|NCT03054298|"~     Phase I study to establish safety and feasibility of intravenous or intrapleural~     administered lentiviral transduced huCART-meso cells with or without lymphodepletion.~     Intravenous administration of huCART-meso cells is planned with or without cyclophosphamide~     as lymphodepleting chemotherapy.~   "
220|NCT03054285|"~     The primary objective of this study is to prospectively assess in randomized fashion whether~     short term anti-seizure prophylaxis in traumatic brain injured patients decreases the~     incidence of seizures in the early post-injury period. A secondary objective is to evaluate~     whether there are differences in mortality, hospital length of stay, functional outcome at~     hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.)~     for patients who receive and do not receive anti-seizure prophylaxis.~   "
221|NCT03054272|"~     Using eye-tracking technology, the aim of this observational study is to compare the visual~     interests between attending physicians and residents watching a Cannot Intubate/Cannot~     Oxygenate (CICO) scripted and simulated scenario~   "
495|NCT03050710|"~     In this study, eligible subjects with moderate to severe nasolabial folds will be treated~     with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36~     weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate~     by the investigator.~   "
48694|NCT02419703|"~     Registry collecting data on use of The STAR™ Tumor Ablation System.~   "
222|NCT03054259|"~     This is a feasibility study to test a new trial design for an important drug in Systemic~     Lupus Erythematosus (SLE or lupus).~      SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of~     the body may be affected, but most commonly lupus causes a rash and arthritis, this affects~     patients' quality of life.~      Lupus is usually treated with steroids or drugs that suppress the immune system. Although~     these help, many patients don't respond well enough and there is also concern for long term~     side effects. There is a new type of treatment called biologics. These target individual~     cells or molecules rather than the whole immune system and may be more effective with fewer~     side-effects. B cells are a part of the immune system that are known to play a role in~     lupus. There is already a biologic that removes these, called rituximab. In rheumatoid~     arthritis and vasculitis (similar to lupus), rituximab has been proven to be effective in~     clinical trials. However, in lupus clinical trials it did not seem to show any benefit. But~     many doctors and patients found that rituximab is effective, but the trials couldn't show~     this because of the way the drug's effects were measured. Therefore it is important that we~     test whether it truly is effective for lupus.~      In this 6 month clinical study the investigators will look at lupus patients who have skin~     disease and arthritis as these are very common and randomise them to receive either~     rituximab or a placebo. Patients will have a careful clinical examination and undergo~     different methods to measure the effectiveness of the treatment. There are new versions to~     rituximab called biosimilars. In this study biosimilar GP2013 will be used.~      If this trial is successful a larger definitive study will be designed based on its results.~   "
223|NCT03054246|"~     The study is aimed to investigate if chewing side preference (CSP) can be used as another~     indicator of hemispheric laterality in healthy adults. Healthy volunteers with no~     oral/dental problems with Angle I occlusion relationship and without any missing teeth will~     be included in the study. The CSP will be determined with the visual analog scale (VAS),~     which is the highly reliable method. Laterality test will be used to determine the preferred~     side for hands, feet, ears and eyes.~   "
224|NCT03054233|"~     The study aimed to compare successful spinal needle insertion between obese and non-obese~     pregnant women in crossed leg sitting position undergoing cesarean section~   "
225|NCT03054220|"~     CYP2D6 is characterized by a huge variability in the general population, mainly because of~     genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an~     impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs~     extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both~     used to describe the phenomenon by which a given subject changes his phenotype to another~     due external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the~     phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can~     be modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be~     dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which~     represents about 60 to 70% of the general population. The aim of the study is to determine~     whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the~     CYP2D6 enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles~     and carriers of one non-functional and one functional allele. In order to elucidate this~     question, CYP2D6 activity will be measured on healthy volunteers by administration of single~     low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine,~     two known CYP2D6 inhibitors.~   "
226|NCT03054207|"~     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit~     multiple risk factors by the nature of their pathology. In addition, the long term~     exposition to antiretroviral drugs has been associated to an increased risk for CVD. HIV~     patients can thus potentially receive antiplatelet therapy concomitantly with their~     antiretroviral treatment. Clopidogrel and prasugrel are thienopyridine antiplatelet agents~     indicated to prevent the recurrence of ischemic events after coronary arteries stenting.~     These pro-drugs are mainly bioactivated by cytochromes P450 (CYP) 3A and 2B6 for prasugrel~     and CYP2C19, CYP3A and CYP2B6 for clopidogrel. Ritonavir is commonly used to boost the~     bioavailability of other HIV drugs through inhibition of CYP3A4 as well as CYP2B6 and~     CYP2C9. This interaction could therefore reduce clopidogrel and prasugrel efficacy by~     reducing the formation of their active metabolites. The aim of the present study is to~     assess the potential drug-drug interaction between clopidogrel/prasugrel and ritonavir. Two~     groups of 12 male subjects will be constituted (12 HIV patients under ritonavir boosted~     therapy and 12 healthy volunteers) in a randomized cross-over clinical trial. All subjects~     will also be genotyped for the CYP2C19. The pharmacokinetics of clopidogrel active~     metabolite and prasugrel active metabolite will be assessed. Furthermore, the~     pharmacodynamic response will be evaluated by two gold standard platelet inhibition tests,~     namely VAsodilator-Stimulated Phosphoprotein Assay (VASP) and VerifyNow® assays. The primary~     endpoint of this study is to compare the pharmacodynamic response to clopidogrel and~     prasugrel in HIV patients to that of healthy volunteers.~   "
227|NCT03054194|"~     Study E2730-A001-001 is a first-in-human, sequential ascending single dose,~     placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of~     a single oral dose of E2730 in healthy participants.~   "
228|NCT03054181|"~     Long-term observational study on the utilisation and outcomes of HyQvia (a product~     consisting of recombinant human hyaluronidase and a human normal immunoglobulin 10%~     solution) under everyday clinical practice conditions.~   "
229|NCT03054168|"~     This study evaluates the effect of increase in testosterone levels in older males and the~     effects of decrease in testosterone levels in young males on muscle protein synthesis.~   "
230|NCT03054155|"~     Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be~     treated on one side with the Alexandrite hair removal laser. The other side will serve as~     the control.~   "
231|NCT03054142|"~     Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the~     hospital. AKI has become a huge medical burden in China. Little information is available~     about this disease burden in our country. The investigators aimed to evaluate the burden of~     AKI and to analyze the related risk factors.~   "
232|NCT03054129|"~     The purpose of the study is to determine whether balance training is effective in patients~     with rotator cuff disease.~   "
1889|NCT03032458|"~     A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine~     gel as analgesics for pain control in shockwave lithotripsy.~   "
234|NCT03054103|"~     Background: Phacoemulsification is the most common surgical procedure performed in the~     United States and European Union and sedation is commonly used during phacoemulsification to~     help alleviate patient anxiety and prevent the patient from interfering with the procedure.~     The investigators have administered ketamine in addition to midazolam in this regard. To~     study the effectiveness of this technique, The investigators proposed a study to determine~     if adding low-dose ketamine to midazolam has any beneficial (or negative) effects on~     operating conditions, patient satisfaction, and recovery during and after unilateral~     phacoemulsification procedures performed using topical anesthesia and intravenous (IV)~     conscious sedation.~      Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a~     randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam~     with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured~     a single surgeon's assessment of surgical conditions, self-reported patient satisfaction,~     postoperative pain score, and duration of postoperative stay. The investigators also~     analyzed the dose of midazolam required to meet subjective anxiolysis in each group.~   "
235|NCT03054090|"~     Most care for chronic conditions is provided by primary care clinicians. Although Virginia~     ranks 4th among the 50 states in average income, it ranks 27th in mortality due to heart~     attacks and strokes. The scope and focus of this project will materially improve the rates~     of screening and treatment of risk factors for heart attacks and strokes, and will give~     primary care clinicians the tools and training to improve the care of other chronic~     illnesses and the delivery of preventive services.~   "
236|NCT03054077|"~     This is a small pilot, feasibility study designed as a quality improvement project. The~     purpose is to identify anxiety in children aged 4-12 years who will receive a sedated~     procedure and to see if the use of an iPad as a focused activity will decrease the level of~     anxiety through a small randomized control trial in the Children's Perioperative Unit.~   "
237|NCT03054064|"~     The purpose of this study is to evaluate the safety and effectiveness of the Indego~     exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular~     Accident (CVA).~   "
238|NCT03054051|"~     This project will test the feasibility of an electronic game to prevent HIV among African~     preadolescents, delivered via inexpensive Android smart phones. In order to collect~     feasibility data for a future randomized controlled trial, this study involves the~     pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya,~     where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be~     carried out with the Kenya Medical Research Institute (KEMRI).~   "
239|NCT03054038|"~     This phase I trial studies the side effects and best dose of afatinib and necitumumab and to~     see how well they work in treating patients with EGFR mutation positive non-small cell lung~     cancer that has spread to other places in the body. Afatinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving~     afatinib and necitumumab may work better in treating patients with EGFR mutation positive~     non-small cell lung cancer.~   "
240|NCT03054025|"~     This pilot clinical trial studies how well a smart phone application works in increasing~     physical activity in breast cancer survivors. A smart phone application that increases~     physical activity may help reduce the likelihood of cancer coming back in breast cancer~     survivors.~   "
241|NCT03054012|"~     Background:~      Functional and aesthetic reconstruction of mandibular defects due to tumour invasion,~     osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good~     anatomic and symmetric reconstruction with stable occlusion and condylar position.~     Classically this was obtained by (pre)bending a reconstruction plate, and providing~     osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM~     software enabling a preoperative planning based on 3D models. This computer-assisted surgery~     (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce~     ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as~     well as the effective reduction in operating time and financial implication.~      Study design:~      Retrospective study.~      All patients undergoing bony reconstruction by free vascularised flap between January 2013~     and August 2016 will be included. Accuracy will be measured between the planned and actual~     result, through segmentation of the mandible in Brainlab software. Parameters regarding~     ischemic time and financial cost will be obtained from the medical files.~   "
242|NCT03053999|"~     The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH)~     who undergo surgery.~   "
243|NCT03053986|"~     Apple polyphenols are mostly acknowledged for their hypoglycaemic properties, but represent~     an apple active fraction with many pharmacological functions. The study aim was to examine~     their effect on uricemia and endothelial function in a sample of overweight subjects. This~     was a two-phases study. The in vitro experiment aimed to evaluate the apple polyphenols'~     ability to lower uric acid in comparison with allopurinol. The in vivo study consisted in a~     randomized, double-blind, parallel placebo-controlled clinical trial involving 62 overweight~     volunteers with suboptimal values of fasting plasma glucose (100 mg/dL≤FPG≤125 mg/dL),~     randomized to be treated with 300 mg apple polyphenols or placebo for 8 weeks.~   "
281|NCT03053492|"~     This study has 2 parts: In one part of this study, people with stroke will either play a~     custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the~     shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will~     determine whether or not one computer game improved arm movement more than the other. In the~     second part of the study, people with stroke, caregivers of people with stroke and stroke~     rehabilitation therapists will meet in several focus groups to design a useful and~     informative Duck Duck Punch performance report.~   "
282|NCT03053479|"~     Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very~     little is known about the factors associated with surgical failure. Studies have identified~     a variety of risk factors: younger age, high body mass index and advanced preoperative~     prolapse (grade III-IV) have been associated with an increased risk of reoperation in some~     studies. According to some studies patients had poorer anatomical outcome after traditional~     repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery~     or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the~     efficacy of these three procedures in a randomized controlled trial.~   "
244|NCT03053973|"~     Rationale:~      Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary~     disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently~     been shown to improve outcomes. However, the mechanism behind these improvements are~     unknown. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and~     repair pathways in patients with COPD. In the present study we aim to investigate, in COPD~     patients with CHRF,~        1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as~          compared to standard care~        2. the relationship between FEV1 change and modification of systemic and airway~          inflammation and remodelling, lung hyperinflation, and airway morphology.~        3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study~          design: multicentre randomised controlled study investigating the effects of NIV on~          airway morphology, airway inflammation and remodelling in hypercapnic COPD patients~          including a control group that will postpone the initiation of NIV for 3 months. In~          addition we will investigate how patient demographics, patient and disease~          characteristics and systemic and airway inflammation predict the response to chronic~          NIV in severe stable COPD. To do this, all patients will be followed for 6 months after~          NIV initiation.~      Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months.~     Furthermore, as we recognise that FEV1 might not be the most important patient-related~     outcome, we will assess which parameters affect health-related quality of life after 3 and 6~     months.~   "
245|NCT03053960|"~     This clinical trial studies how well helical computed tomography (CT), positron emission~     tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography~     (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw~     bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI,~     and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence~     or absence of jaw invasion may help create a better surgical treatment plan for patients~     with oral cancer.~   "
246|NCT03053947|"~     Lacerations are one of most common trauma in children presenting to the emergency department~     (ED). Currently, there are wide variations regarding sedation and analgesia practices when~     suture are required. Even though topical anesthesia is very useful to reduce pain, it does~     not obviate the use of pharmacologic agents to decrease stress in anxious children~     undergoing laceration repairs in the ED.~      There is a growing interest in the intranasal (IN) route of administration in the pediatric~     population. It bypasses the first hepatic passage and thus provides medications direct~     access to the systemic circulation leading to higher and faster serum concentrations than~     would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain~     associated with it and the need for nursing time and procedure delay. IN fentanyl and~     midazolam are two agents that can be combined for this procedure, but respiratory depression~     is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural~     sedation, and can offer potent analgesia and sedation while maintaining respiratory drive~     and protective airway reflexes. Few studies have evaluated IN ketamine for procedural~     sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the~     question as what is the lowest possible dosage that can be used to successfully repairs~     laceration in children with minimal restrain and no adverse events, as described by the~     Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research~     Network (PECARN) consensus.~   "
247|NCT03053934|"~     The objective of the study is to establish whether online video counselling is at least~     equally acceptable and equally as effective to clients and clinicians of the Veterans and~     Veterans Families Counselling Service (VVCS) as in-person counselling. If this is confirmed~     by the evaluation then online video counselling can be made more widely available to support~     the veteran and ex-service community, especially for those who may otherwise be unable to~     attend therapy and for clients who would prefer such web-based services over in-person~     sessions.~   "
248|NCT03053921|"~     Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally~     advanced flap in covering single and multiple Miller's class I and II gingival recession~     defects.~   "
249|NCT03053908|"~     Alzheimer's disease (AD) is a common neurodegenerative disease characterized by the~     accumulation of amyloid plaques and neurofibrillary tangles. Current consensus is that the~     AD pathological process begins decades before clinical symptoms occur. This long~     preclinical phase of AD might first become detectable in middle-age as deposits of~     hyperphosphorylated tau (P-tau) in the transentorhinal cortex and subcortical nuclei such as~     the locus coeruleus (LC) and the nucleus basalis of Meynert. There is strong preliminary~     evidence showing that cerebrospinal fluid (CSF) levels of orexin-A (OxA) are associated with~     increased P-tau (r=.52, p<.01) and total-tau (T-tau) (r=.42, p<.01) in cognitively normal~     older adults (mean age: 69.6±8.6 years).~      This study poses that onset of tauopathy in the LC results in down regulation of orexin~     receptors, leading to a homeostatic increase of OxA production by the hypothalamus, which~     results in changes in core body temperature (CBT) and sleep disruption that cause further~     neurodegeneration. This hypothesis will be tested by demonstrating that increases in CSF~     P-tau are associated in vivo with tau PET uptake, and that tau binding in the LC is~     associated with increases in CSF OxA (Aim 1); and second, by analyzing the downstream~     consequences of increased central nervous system (CNS) OxA on sleep architecture and CBT~     (Aim 2). To test these hypotheses, 30 older adults (age 55-75) balanced by sex, will first~     perform a full clinical evaluation and MRI (visits 1-2). Subjects will later undergo 7 days~     of actigraphy followed by nocturnal polysomnography (NPSG) for 2 consecutive nights (N1-2)~     during which we will measure CBT (visits 3-4). A morning lumbar puncture (LP) will be~     performed after N2 to obtain CSF. Tau burden will be analyzed by PET-MR using 18F-THK5351,~     which will be performed 1-4 weeks after the LP (visit 5).~   "
283|NCT03053466|"~     The purpose of this study is to determine the safety, tolerability, and recommended dose of~     CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.~   "
284|NCT03053453|"~     The purpose of this study will be to evaluate and compare patients undergoing total knee~     arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient~     will be assessed for the difference between passive, soft tissue controlled, pressure~     balance and muscle activated pressure balance.~   "
285|NCT03053440|"~     This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib~     in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.~   "
286|NCT03053427|"~     The objective of this study is to assess the efficacy of once-daily oral administration of~     Gabapentin enacarbil versus placebo, based on the change in International Restless Legs~     Syndrome Rating Scale (IRLS) score in subjects with moderate-to-severe primary Restless Legs~     Syndrome. This study will also assess the safety of Gabapentin enacarbil.~   "
250|NCT03053895|"~     DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)~      CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue~     compression leading to neurological complications. One of the most common risk factors~     contributing to CSDH is head trauma, which is usually in the form of a minor head injury.~     Older individuals are at increased risk of CSDH due to brain atrophy that occurs with~     advancing age as well as their tendency to fall and sustain minor head traumas. Chronic~     alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased~     risk of falls, and liver failure which results in increased bleeding risk. Also many drugs~     used today like anticoagulants, antithrombotics, and antiplatelets for certain health~     conditions are other common risk factors for CSDH.~      The overall goal of this multi-centered trial in the USA and Canada is to assess the~     surgical management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness~     of bedside drainage and its safety as it bypasses the perioperative risk associated with~     anesthetic especially among the elderly.~      Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of~     two procedures. One group will receive the twist drill procedure which can be performed at~     the bedside. The second group will undergo the burr-hole drainage procedure in the operating~     room usually under general anesthetic. Typically, the twist drill procedure can occur sooner~     as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be~     assessed over a period of 6 months following drainage. Timing of procedure, risk of~     infection, adverse side effects and neurological functioning will also be measured.~      Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled.~     Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the~     two procedures and will be followed for study outcomes at 1, 3 and 6 months following the~     procedure.~      Primary analysis will be to compare the surgical procedures, assessing the recurrence rate~     of CSDH within 6 months of initial CSDH drainage.~      The ultimate goal of this study is to standardize bedside drainage as the treatment of~     choice for CSDH management.~      This trial is important in the ongoing search for more efficient and safe intervention~     strategies.~   "
251|NCT03053882|"~     Background:~      Herbal remedies can have the role of prevention and control of bad breath Since in the~     previous studies, therapeutic and antibacterial effect of green tea and peppermint had been~     proven .we studied and compared the effects of green tea and peppermint mouthwashes on~     halitosis.~      Materials and Methods:~      This single-blind clinical trial study with cross over design total of 88 volunteer dental~     students who complained bad breath and had organoleptic score (>= 2) and higher average test~     scores were enrolled. The students were divided randomly into two groups Green Tea -~     Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21~     measured after rinsing the mouthwashes .As well as the satisfaction of both plants on the~     last day was considered. Data analysis was performed using tests; Wilcoxon signed rank test,~     Mann Whithney u, GEE (Generalized Estimating Equation -ordinal logistic regression).~   "
252|NCT03053869|"~     The purpose of this research study is to find out if a cardiac anesthesia policy that uses~     alternatives to benzodiazepine medications is better at preventing delirium after cardiac~     surgery when compared with a cardiac anesthesia policy that uses benzodiazepine medications.~   "
253|NCT03053856|"~     This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive~     non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent~     chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg~     every 3 weeks for up to 24 months.~      The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab~     treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid~     Tumors (RECIST) 1.1 as assessed by the investigator).~      The baseline assessment is part of the screening procedures and should be performed within 0~     to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1~     assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients~     will be assessed every 12 weeks for the first year, every 16 weeks for the second year,~     every 6 months for the third year, and every year thereafter. In subjects who discontinued~     study therapy without documented recurrence, every effort should be made to continue~     monitoring their disease status.~      If an unscheduled assessment is performed, and the patient has not progressed, every attempt~     should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1~     scans will be analyzed by the investigator on site; a central review will not be conducted.~      Following completion or discontinuation of study drug, patients will enter a follow-up~     period.~      Once a patient has had objective relapse recorded and has discontinued study drug, the~     patient will be followed for survival status every 3 months until death, withdrawal of~     consent or the end of the study.~      Patients will also be requested to provide tumor samples from diagnostic (obtained before~     neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision~     is not optional, subject to a specific consent.~   "
254|NCT03053843|"~     Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents~     a high priority public health problem, as in a few decades it will become a possibly~     unsustainable load for the national health system. Preventive and therapeutic strategies~     based on the best possible scientific evidence are required. Ablation therapy, despite being~     the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An~     intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective~     in primary prevention and reduced the incidence of AF in high-risk subjects in a recent,~     large, randomized trial (PREDIMED).~      Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients~     with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1)~     intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary~     objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At~     least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of~     0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12,~     18 and 24 months. In addition to the in-person visits, event monitors will be used to~     document episodes. Dietary intervention will be carried out by nutritionists who will use~     methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per~     week will be provided for free in the intervention arm. Inflammatory markers will be~     analyzed in both groups during follow-up. Cox models will be used to estimate adjusted~     hazard ratios.~   "
255|NCT03053830|"~     Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up~     to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will~     occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the~     longer term effects of ketamine.~   "
256|NCT03053817|"~     Exercise programs that combine resistance exercise with aerobic training yield optimal~     health benefits for people with HIV. The global aim of this study is to contribute evidence~     for the impact potential of a comprehensive exercise program on brain health in people with~     HIV.~      This study is part of a larger project based upon a cohort multiple randomized controlled~     design. Within a fully characterized cohort which is followed over time, people meeting the~     specific criteria for an exercise intervention will be identified. The sample will be~     randomly selected to receive the intervention; the remaining eligible persons will serve as~     controls. The intervention group will receive a 45 minute structured exercise program 3~     times a week consisting of aerobic exercise and resistance training for a total of 12 weeks.~   "
257|NCT03053804|"~     It is a study that hypothesize that MR/PET can have better information than current CT image~     study, about the medical or surgical treatment outcome of lung cancer~   "
1344|NCT03039621|"~     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon~     in the treatment of acute respiratory viral infections in children aged from 6 months to 6~     years.~   "
258|NCT03053791|"~     Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the~     spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face~     a life in the wheelchair. Besides conventional rehabilitation, no prominsing further~     treatment options exist. One of the most plastic systems involved in locomotion is the~     pontomedullary reticulospinal tract, which is the oldest locomotor command system existing~     in most vertebrates, including primates. Muscle activation patterns for limb movements are~     programmed in the spinal cord and have to be activated and coordinated through commands from~     the so called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the~     lower mesencephalic tegmentum sending uni- and bilateral signals through the medullary~     reticulospinal tracts. Classical physiological studies showed that electrical stimulation of~     the MLR induce locomotion. For the first time this approach was transferred and recently~     published in a model of induced incomplete spinal cord injury by the Schwab group. Rats~     severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered~     with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even~     rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a~     clinical standard treatment option in patients with movement disorders but does not relieve~     all symptoms. Therefore, small studies of MLR stimulations have been safely used in~     Parkinsonian patients showing freezing of gait and frequent falls with variable results. In~     a translational approach, we aim at performing a multidisciplinary phase one clinical trial~     with 5 patients and incomplete spinal cord injury. With the means of our established~     universitary setup for DBS treatments the operations will be performed unilaterally under~     local anaesthesia in the Division of Neurosurgery, USZ, with perioperative~     electrophysiological recordings, clinical assessments and gait analysis under test~     stimulation in the Spinal Cord Injury Center Balgrist.~   "
259|NCT03053778|"~     This study aims to explore and reduce readmission rates, while improving health-related~     quality of life through patient-reported outcomes (PROs) and after Heart Valve Surgery. This~     will be investigated through surveys and by a trial investigating the effect of an early~     rehabilitation effort in a Heart Valve Clinic format.~   "
260|NCT03053765|"~     The study is designed to develop and validate an instrument to measure quality and adherence~     to IPT for research and training purposes. The measure is now being used to evaluate~     training in IPT.~   "
261|NCT03053752|"~     Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This~     case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on~     acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and~     3 of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for~     Parkinson's Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints,~     with the current Burst. We used the paired sample t-test, considering p ≤ 0.05.~   "
262|NCT03053739|"~     The study will be carried out on 50 consecutive consenting patients of systemic sclerosis~     with PAH recruited from outpatient department of internal medicine and rheumatology clinic~     of PGIMER, Chandigarh, India It is a single centre double blind randomised controlled trial~     evaluating the effect of upfront dual therapy (sildenafil and bosentan) vs monotherapy~     (sildenafil) Participants will be randomised in 1:1 ratio to one of treatment arms. Placebo~     and PDE-5 inhibitors 20 mg BD to 60 mg if patient tolerates the drug well to one study arm~     and PDE-5 inhibitors plus ER antagonist 62.5 to max of 125 to other study group~   "
263|NCT03053726|"~     In the VFS paradigm the stimulation frequency was set to alternate between high and low~     frequencies, where the frequency of stimulation or frequency combinations can be changed~     instantaneously according to damage of the moment rhythms. Variable frequency stimulation is~     a novel dynamic therapy which breaks through the existing single high-frequency stimulation~     paradigms. It is the world's first VFS therapy for the brain.~   "
264|NCT03053713|"~     The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the~     intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of~     this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and~     the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to~     determine if the MDP results in changes to the intestinal bacteria or immune system.~   "
265|NCT03053700|"~     This is an interventional and prospective study. The study is designed to evaluate the~     additional benefits of a combination of IPL treatment and local application of Bromonide~     0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).~   "
266|NCT03053687|"~     The Proposed study is a double blind, randomized, placebo controlled study The aim of the~     study is to evaluate the effect of combined Growth Hormone (GH) treatment & nutritional~     formula supplementation versus GH & placebo on growth parameters in 64 children with~     Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.~      In this trial GH is a background treatment (non-investigational medicinal product.~     Participants may be treated with any of the commercial GH products approved in Israel for~     the indication of IGHD.~      Participants will be randomly assigned either to the intervention group or the placebo~     control group. Randomization for the two study groups will be made in a ratio of 1:1. Both~     participants and study team will be blinded to the type of treatment that each patient will~     receive during the study. The randomization will be done according to gender and tanner~     stage.~      Participants in the intervention groups will be treated with the study formulas and~     participants in the control group will be treated with a placebo low caloric formulas~     (Powder added to water) The study will continue for 6 months of intervention versus active~     placebo, with additional 6 months (an extension period), in which participants at both~     groups, the intervention and the placebo, will be offered to continue their participation in~     the study with the active study supplement.~   "
267|NCT03053674|"~     The aim of this study is to determine whether an explanation to parents for the need for~     post-partum influenza vaccination will influence their compliance.~   "
268|NCT03053661|"~     The IRECT trial is a non-interventional, prospective clinical trial using modern immune~     monitoring techniques over the course of the standard of care for HNSCC. The dynamics of~     host/tumor immune interactions during the conventional standard treatment will be analyzed~     to find the most promising target antigen and to develop a strategy how and when specific~     immunotherapy should be added to the current treatment schedule.~      The results from this trial will help to understand how state of the art treatment can be~     complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to~     improve the outcome of head and neck cancer patients.~   "
308|NCT03053141|"~     The objective of the RHAPSODY study is to evaluate the performance of new software features~     in subjects undergoing standard of care catheter-based endocardial mapping for atrial or~     ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this~     study will be used to guide development and refinement of new software features that may be~     implemented in future commercial software releases.~   "
269|NCT03053648|"~     Abstract~      Objectives: To explore the clinical effects of self-acupressure for treating insomnia~     delivered by a training course.~      Hypothesis: Subjects who have participated in the self-acupressure training course will have~     greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene~     education control group at 4 and 8 weeks.~      Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be~     recruited from the community. 30 subjects will be randomized to self-acupressure and sleep~     hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index~     (ISI) will be used to assess insomnia symptoms and daytime impairment.~      Interventions: Subjects in the self-acupressure group will attend two training sessions to~     learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects~     in the sleep hygiene education control group will receive two training sessions to learn~     sleep hygiene practice.~      Main outcome measures: The primary outcome measure is the ISI score. Other measures include~     sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and~     SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be~     evaluated.~      Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be~     examined using a mixed-effects model.~   "
270|NCT03053635|"~     This is a phase Ib, open-label, single-arm, single-center study conducted in Canada.~     Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical~     cystectomy will be eligible for participation in the study. BCG intolerance or refractory~     disease are defined as inability to tolerate or failure to achieve a tumour-free state after~     at least one induction (a minimum of 5 instillations) followed by either a second induction~     (a minimum of 5 instillations) or at least 2 maintenance instillations. Subjects~     experiencing disease relapse within 12 months or less after finishing the second course of~     BCG therapy are also considered refractory. The study will consist of 2 phases. In the first~     phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35 mg/cm^2 (maximum~     recommended starting dose) TLD1433. If treatment with the maximum recommended starting dose~     does not raise significant safety concerns as determined by the safety monitoring committee,~     an additional 6 subjects will receive PDT with 0.70 mg/cm^2 (therapeutic dose) TLD1433.~   "
271|NCT03053622|"~     This study is conducted to compare how much LY3074828, in two different formulations, is~     absorbed into the bloodstream and how long the body takes to get rid of it, when given as an~     injection under the skin or into the veins. Side effects of the injection will be collected.~     Each participant will be in the study for about 18 weeks, including screening.~   "
272|NCT03053609|"~     Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal~     Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.~      Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the~     temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events~     in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms~     and, whether this association is significant, to clarify the impact of GER on CR events.~   "
273|NCT03053596|"~     The main purpose of this registry is to assess liver toxicity, treatment efficacy, and~     safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with~     unresectable hepatocellular carcinoma allocated to TACE treatment.~   "
274|NCT03053583|"~     The purpose of this study is to compare straight blades in obtaining best glottic view in~     children. The investigators will compare size 1 Classical Miller, size 1 Wis-Hipple, and~     size 1 C-MAC straight blades in young children.~   "
275|NCT03053570|"~     The purpose of this study is to perform a prospective, randomised study investigating the~     safety and efficacy of cryoballoon catheter ablation compared with radiofrequency~     ablation(contact force), in the treatment of persistent AF.~   "
276|NCT03053557|"~     This study aims to test a new device called the Social Skills Coach that is being created to~     help mental health consumers with social skills and community functioning. People diagnosed~     with schizophrenia and clinicians will be included as participants in this study. Mental~     health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the~     new device or to participate in a social skills training course. Data will be collected from~     participants through surveys before participants either use the device or participate the~     course and afterwards. Individual interviews will be conducted with a sub sample of mental~     health consumers and clinicians. The study looks to test the credibility and acceptability~     of the new device to help mental health consumers and clinicians. it will also influence~     future research.~   "
277|NCT03053544|"~     This internal pilot will be the first prospective study to assess the feasibility and~     efficacy of adding metformin in non‐diabetic rectal patients who undergo standard of care~     neoadjuvant chemoradiation therapy (CRT). The translational aim of the study will inform on~     predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). Metformin~     has been used for decades in patients with type 2 diabetes and has an extremely safe~     toxicity profile. With current interest in the use of metformin as a cancer therapeutic in~     non‐diabetics, this study is expected to provide proof‐of principle data for a larger study.~   "
278|NCT03053531|"~     The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot),~     gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED.~     Since the HERO-ED Pilot does not involve random assignment (no control group), it will not~     test device effectiveness. However, the HERO-ED Pilot will test device acceptability and~     use. It will also provide preliminary data on, and allow us to fine-tune, the measures of~     effectiveness that we plan to use in HERO-ED~   "
279|NCT03053518|"~     This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a~     North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage,~     single-group feeding study in 20 individuals, including 10 participants managed with~     lifestyle alone, and 10 managed with lifestyle plus metformin.~   "
280|NCT03053505|"~     This study is a two-arm, interventional, prospective, open-label, multi-center clinical~     trial with randomized and non-randomized study groups to evaluate the safety and~     effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients~     suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel,~     standardized microbiota transplantation system.~   "
2607|NCT03023085|"~     The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel~     preparation prior to colonoscopy in adult patients.~   "
287|NCT03053414|"~     Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease~     (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is~     thought to result from a complex interaction between genetic, immune, microbial and~     environmental factors. There is emerging data suggesting Vitamin D may not only play a role~     in bone health but may also be involved in gut health as well. While there are guidelines~     regarding the recommending doses of Vitamin D for supplementation and maintenance in bone~     health, these strategies are unknown in those with inflammatory bowel disease. The~     investigators seek to determine a dosing strategy for this population using doses within the~     recommended guidelines for bone health.~   "
288|NCT03053401|"~     Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been~     used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge,~     no comparison has been made between these blocks in relation to postoperative quadriceps~     muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL~     repair in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee~     surgery comparable to FNB, it has the potential to improve the postoperative outcome as it~     will lead to less quadriceps muscle weakness and early mobilization, both of which are very~     important in the early postoperative period.~   "
289|NCT03053388|"~     Double blind, randomized multi-center, evaluation of the efficacy, safety and tolerability~     of Nitric Oxide (NO) given intermittently via inhalation to subjects with acute~     bronchiolitis.~      Bronchiolitis is defined as an infection of the small airways. It is also the most common~     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the~     leading cause of global child mortality.~      Nitric Oxide (NO) has been shown to play a critical role in various biological functions,~     including in the vasodilatation of smooth muscle, neurotransmission, regulation of wound~     healing and during immune responses to infection with a microbicidal action directed toward~     various organisms. In the airways, NO is considered to play a key role in the innate immune~     system in which the first-line of host defense against microbes is built.~      The beneficial effect of NO has been shown in different diseases with several options of~     doses and regimens; newborn with primary pulmonary hypertension showed improvement in~     oxygenation after 30 minutes of NO treatment at 10-20 ppm, while subjects with adult~     respiratory distress syndrome demonstrated clinical improvement during NO treatment at 18~     and 36 ppm.~      In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses~     antimicrobial and anti-viral activity against a wide variety of phyla including bacteria,~     viruses, helminthes and parasites.~      Safety and tolerability of 160 ppm NO given intermittently via inhalation were shown in a~     phase II study performed on 2-12 month infants hospitalized with bronchiolitis. According to~     data no difference in the proportion of adverse events and serious adverse events were~     detected between subjects treated with NO and subjects treated with standard supportive~     treatment.~      In this study the investigators wish to assess the efficacy of 160 ppm NO given~     intermittently via inhalation to 0-12 months-old infants hospitalized due to acute~     bronchiolitis.~      Primary objective: Asses the difference in hospital Length of Stay (LOS) between subjects~     treated with 160 ppm NO combined with standard supportive treatment and subjects treated~     with standard supportive treatment.~      Secondary objectives: Asses the difference in the time required to achieve clinical~     improvement, a clinical score ≤5 (Modified Tal score) between subjects treated with 160 ppm~     NO combined with standard supportive treatment and subjects treated with standard supportive~     treatment. Assess the difference in the time required to achieve sustained 92% oxygen~     saturation in room air between subjects treated with 160 ppm NO combined with standard~     supportive treatment and subjects treated with standard supportive treatment. Characterize~     the safety and tolerability of 160 ppm NO intermittent inhalation treatment as measure by~     the rate of adverse events.~      In this prospective double-blind, randomized multi-Center study the investigators will~     enroll up to 120 (no less than 80) subjects aged 0-12 months-old, diagnosed with acute~     bronchiolitis and requiring in-patient hospitalization.~      Enrolled subjects will be randomized into 2 groups. Group 1 -Treatment group - Will receive~     160 ppm NO given intermittent via inhalation in addition to standard treatment for up to 5~     days. Group 2 - will receive ongoing inhalation of the standard treatment for up to 5 days.~     Between study and after completing all study inhalations the subject will continue to~     receive the standard treatment. Oxygen (O2), NO, nitrogen dioxide (NO2) and fraction of~     inspired oxygen (FiO2) delivered to the patient will be continuously monitored.~      Treatment administration: Treatment blindness will be kept by separating between un-blinded~     team members (giving the actual treatment) and blinded team members, and by hiding the NO~     container and all study related equipment behind a curtain.~      All subjects will return for follow-up visits on day 14(+5), 21(+5) days and will be~     contacted on day 30 (+5) from day of admission to the department.~   "
290|NCT03053375|"~     This study will examine the effects of a portable of pulsed electromagnetic field (PEMF)~     device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of~     pain and function in patients with either acute/subacute or chronic low back pain (LBP).~   "
291|NCT03053362|"~     The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring~     change in cognitive deficits in individuals with MDD after receiving vortioxetine.~      Vortioxetine is used in this study as an antidepressant to improve mood, cognition and~     quality of life. Cognition refers to intellectual functions such as thinking,~     understanding, learning and remembering. Vortioxetine is approved by Health Canada for the~     treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on~     cognitive areas such as executive function, attention/speed of processing, and memory, that~     are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in~     the EU and many other countries as having a benefit on cognitive dysfunction (loss of~     intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent,~     pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.~      It has also been shown that among adults with MDD who are gainfully employed, measures of~     cognition are a greater determinant of overall workplace performance than is total~     depression symptom severity. Several lines of evidence indicate that cognitive deficits that~     persist between episodes of depression are critical determinants of functional recovery in~     the workplace. The functional implications associated with cognitive impairment provide the~     impetus for systematic evaluation, measurement and assessment of the domains of cognition~     expected to be impaired in this patient population.~      To date, no measurement tool has been sufficiently validated and/or determined to be~     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of~     available comprehensive psychometric tools include relative lack of availability, cost, lack~     of access to most healthcare providers, and above all else, the lengthy time to administer.~     Moreover, the need for a psychometrist to interpret the results adds to the complexity and~     the costliness of such an endeavor.~      It is imperative that any tool recommended for clinical utility be aligned with the busy~     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the~     presence of cognitive dysfunction in MDD in the clinical environment should include, but not~     be limited to, features such as good conceptual coverage of cognitive domains affected in~     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture~     effects and practice effects. The tool would also need to be brief, easy to administer and~     interpret, and complement busy clinical practice.~      It is anticipated that the THINC-it tool will be free of charge and downloadable from the~     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will~     be accessible via computers/tablets, will take 20 minutes to self-administer in a clinical~     setting, and the performance results will be immediately available.~   "
292|NCT03053349|"~     Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor~     pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical~     practice at the most active transplant centers in North America and Europe.~      The aim of this observational prospective monocentric study is to prove the safety and~     efficacy of EVLP performed in the setting of Bergamo lung transplant program.~      A statistically estimated sample size would not fit with the small numbers of Italian lung~     transplant activity, so the investigators decided to enrol 10 consecutive recipients of~     grafts subjected to EVLP.~      Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and~     standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP.~      The donor lung procurement operation will be done in the usual manner. The EVLP procedure~     will be performed in the operating theater of Papa Giovanni XXIII Hospital. The~     investigators decided to adopt Toronto protocol since it involves some lung protective~     strategies. EVLP will proceed over a period of at least 4 and not more than 6 hours.~      After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be~     evaluated:~        -  ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen~          (PO2/FiO2, mmHg)~        -  Pulmonary Vascular Resistance (PVR, dine*s/cm5)~        -  Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)~        -  dynamic lung Compliance (Cpldyn, ml/ cmH2O)~        -  ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240~          minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.~      The lung graft will be accepted for transplantation if, after 240 minutes from the start of~     EVLP, the following conditions are fulfilled:~        -  PO2/FiO2 >350 mmHg~        -  stability or reduction of PVR compared with the measurement at the baseline assessment~          time point~        -  stability or reduction of PIP and Pawm compared with the measurement at the baseline~          assessment time point~        -  stable or better Cpldyn compared with the measurement at the baseline assessment time~          point~        -  ΔPO2 >400 mmHg~        -  improvement of X-ray imaging compared with that at the baseline assessment time point~        -  exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the~          recipients will be followed-up for 1 year according to a scheduled timetable.~      Data about the EVLP and transplant procedure and about the characteristics of donors and~     recipients will be collected in a dedicated electronic Case report form (eCRF) according to~     Good Clinical Practice.~   "
293|NCT03053336|"~     The aim of this study is to investigate the effect of using new app-based technology to~     improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis~     is that the intervention, i.e. using the new technology, will have a greater positive effect~     on physical activity levels and outcomes of HbA1c than usual care.~   "
294|NCT03053323|"~     The purpose of the Preconception and Pregnancy Obesity Treatment and Prevention Among Women~     with A History of Depression preliminary study is to provide a lifestyle intervention for~     women with a history of depression who are trying to conceive or are pregnant in order to~     prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to~     improve other markers of metabolic health. The treatment program consists of 10 private~     sessions with a trained clinician at no cost to participants.~   "
309|NCT03053128|"~     Coronary heart disease (CHD) is a public health care challenge. There are three types of~     treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery~     bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those~     treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients,~     which is used in tens of countries all over the world. Safety, invasiveness, effectiveness~     is its advantage. Ischemia condition can be improved after CSWT. There are only three cities~     in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators~     designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.~   "
686|NCT03048201|"~     The primary objective of this study is to obtain long-term implant survivorship (out to 10~     years) and to assess clinical, patient-reported outcome measures, and radiographic data for~     the commercially available Physica system.~   "
295|NCT03053310|"~     Background Approximately half of head and neck cancer patients are 65 years or older at~     diagnosis. Treatment decisions in this older HNCA population are challenging, because of the~     lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA~     setting where curative treatment is intended. Though chronological age per se has not been~     reported as a contraindication for surgery, data are limited and often the result of~     retrospective studies. Measurement of functional age, through a comprehensive geriatric~     assessment, has been suggested by several international cancer organizations to be a better~     prognostic indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a~     geriatric assessment is part of routine preoperative staging for patients of 70 years old or~     older.~      Objectives The investigators aim to determine the value of G8 to predict 30-day~     postoperative comorbidity in an older HNCA population undergoing elective curative surgery.~     Moreover, they aim to examine the vulnerability profile of patients undergoing elective head~     and neck surgery for an oncology diagnosis.~      Study design All patients of 70 years and older, presenting at the divisions of~     maxillofacial surgery and otorhinolaryngology for curative surgery of a solid head and neck~     tumour undergo a geriatric consult as part of routine preoperative staging. The presence of~     postoperative morbidity and mortality within the first 30 days after surgery will be~     collected as a primary endpoint.~      At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA.~     Patient' quality of life will also be re-examined within 30 days postoperative and again at~     6 and 12 months postoperative.~      Conclusion There is still no consensus whether older HNCA patients should receive a~     different treatment compared to younger patients. Data related to the vulnerability profile~     of older patients requiring HN surgery, and the predictive value of geriatric screening for~     postoperative morbidity could enable better patient selection in the future.~   "
296|NCT03053297|"~     This is an observational cohort study of patients with locally advanced or metastatic NSCLC~     (non-small cell lung cancer).~      Patients will be recruited from participating sites in Europe, Asia, and Canada. The study~     will include 2 patient cohorts.~   "
297|NCT03053284|"~     This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on~     preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and~     insulinoma.~   "
298|NCT03053271|"~     This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101~     to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous~     Cushing's syndrome. Following wash-out, all eligible subjects will undergo a 6-week~     open-label dose escalation with ATR-101. Subjects who continue to be eligible will then~     undergo a 4-week randomized withdrawal period. It is anticipated that the overall duration~     of the study per subject will range from approximately 14-20 weeks.~   "
299|NCT03053258|"~     Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to~     identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in~     previous animal models.~      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis~     System in the early detection of VOC's associated with VAP.~   "
300|NCT03053245|"~     The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative~     critical care recovery program from acute respiratory failure (ARF) survivors in~     accomplishing the Institute of Healthcare Improvement's triple aims of better health, better~     care, at lower cost.~   "
301|NCT03053232|"~     Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of~     gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic~     mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers.~     Endoscopic procedure associated gastrointestinal perforation is one of the the most severe~     complications, which is associated with high morality and needs timely detection and~     effective treatment in clinical practice.Over 90% procedure associated gastrointestinal~     perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been~     widely used in closing the immediate gastrointestinal perforations, but the location of the~     endoclips could influence the effective rate, limiting its application. In addition,~     multiple endoclips should be placed under endoscopy for a relatively large perforation,~     which could increase the medical cost and the procedure time. At recent, a new purse string~     suture device (LeoMed, China) has been developed by us and introduced to the~     clinicalmanagement of such patients with procedure associated gastrointestinal perforations.~     Clinical data validated that the usage of this new purse string suture in treating immediate~     procedure associated perforations was greatly convenient and effective with very low~     reoperation rate and postoperative complication rate. A specially designed loop was equipped~     in this device, which could be tightened under endoscopy. Thus, compared with the placement~     of endoclips, this device could be more convenient and effective in completely closing the~     gastrointestinal perforations.This study will test whether purse string suture device will~     increase the effectiveness of closingimmediate procedure associated gastrointestinal~     perforationsunder endoscopyin a randomized controlled trialby comparing the use of purse~     string suture deviceand endoclips.~   "
302|NCT03053219|"~     The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced~     NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and~     excretion) trial and subsequent receiving AC0010 treatment~   "
303|NCT03053206|"~     One-third to one-half of patients with AML relapse and in general relapsed AML patients have~     a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed~     by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage~     chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be~     significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active~     agents in AMLand have been used as monotherapy and in combination in refractory and relapsed~     AML patients. According to previous studies the present CR rate of different regimens ranges~     from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML~     patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the~     CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy~     and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.~   "
304|NCT03053193|"~     The FLEX Registry will be implemented to operate as a large-scale, population based,~     prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®~     and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX~     Registry, which is intended to enable additional study arms at low incremental effort and~     cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies~     and arms can be added after the initial study is opened.~   "
305|NCT03053180|"~     This prospective, multi-center, observational study is designed to assess the real world~     effectiveness and safety of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting~     antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) in participants with chronic~     hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in~     Russia.~   "
306|NCT03053167|"~     Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through~     different mechanisms, and have only partially overlapping toxicity profiles. The purpose of~     this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line~     treatment in advanced colorectal cancer patients.~   "
307|NCT03053154|"~     The purpose of this study is to assess and determine the influence of pelvic inclination on~     sit to stand task in stroke patients.~   "
621|NCT03049046|"~     Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to~     1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are~     required to stay in the Clinic for approximately 9 hours following the first and last dose.~     Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5~     days after the last dose.~   "
310|NCT03053115|"~     The aim of the study is to evaluate the peripheral tissue response to the combined~     administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with~     residual thyroid function virtually absent (thyroidectomized). Cases will be treated with~     LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian~     rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and~     placebo. Treatment duration: 24 weeks.~      The primary endpoint will be the peripheral effect of thyroid hormones, measuring tissue~     markers levels, such as thyroid stimulating hormone(TSH), sex hormone binding globulin~     (SHBG), total cholesterol, LDL cholesterol, lipoprotein A, osteocalcin, urinary~     N-telopeptide, ferritin, myoglobin, creatine kinase, glucose 6 phosphate dehydrogenases,~     angiotensin-converting enzyme (ACE). The secondary endpoints are bone and metabolic~     modifications, evaluated by DEXA, quality of life, tissue specific miRNA expression,~     polymorphisms of genes involved in thyroid hormones metabolism.~   "
311|NCT03053102|"~     The purpose of this study is to determine the safety and effectiveness of ACH-0144471 in~     currently untreated patients with PNH.~   "
312|NCT03053089|"~     AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This is a safety and~     tolerability study to obtain safety and exposure data as well as information on the~     biological activity of the investigational drug.~      This is a two-stage, sequential, single and multi-dose study of AGT-181 in patients with MPS~     I. The first stage will be an open-label, single-dose, dose-escalation cohort study and the~     second stage will be an open-label, multi dose, adaptive dose escalation cohort study.~   "
313|NCT03053076|"~     To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells~     transfusion on clinical outcome in preterm infants~   "
314|NCT03053063|"~     The primary objective of this study is to evaluate whether selonsertib (SEL) can cause~     fibrosis regression and reduce associated complications in adults with cirrhosis due to~     NASH.~   "
315|NCT03053050|"~     The primary objective of this study is to evaluate whether selonsertib (SEL) can cause~     fibrosis regression and reduce progression to cirrhosis and associated complications in~     adults with NASH and bridging (F3) fibrosis.~   "
316|NCT03053037|"~     This study is looking into two different ways to perform a root canal treatment. The study~     will look at differences and compare the two different treatment options over a 2-year~     period.More specifically, this study evaluates a small skinny root canal shape compared to~     a larger broad root canal shape and if this affects the success of the root canal~     treatment. Both types of treatment are standard of care and aim to treat the infection~     inside your tooth. When a tooth is infected with bacteria, we can see a dark area on the~     radiograph around the roots of the infected tooth. If this dark area becomes smaller or goes~     away completely after root canal treatment and you do not feel any pain or other symptoms,~     then we know that the treatment was successful and there is no need for further treatment on~     this tooth. To measure the size of the dark area around the tooth (i.e. volume) before and~     after the treatment we will need to take two limited volume three-dimensional radiographs~     (cone beam computed tomography-CBCT), one prior to treatment and one at two years after the~     root canal treatment is completed. These radiographs are more accurate in detecting changes~     in lesion size than the regular periapical radiographs. We will assess the changes in lesion~     volume for all teeth included in the study and that will help us find differences in success~     between the two root canal treatment protocols, We are specifically looking for persons that~     have been diagnosed with a necrotic permanent mandibular molar with an evident radiographic~     lesion (i.e. dark area around the tooth) that can be retained in the mouth with root canal~     treatment and permanent restoration. This study place participants in different treatment~     groups after randomization. Randomization means that you are placed by chance (like flipping~     a coin) into a treatment group. For this study, there are two treatment groups (protocol)~     and they are listed below.~      Protocol 1: Group S: Root canal treatment will be performed in 2-visits using hand files and~     rotary instruments to a final canal shape of size #25.~      Protocol 2: Group L: Root canal treatment will be performed in 2-visits using hand files and~     rotary instruments to a final canal shape of size #35~   "
317|NCT03053024|"~     The purpose of the study (retrospective and prospective) is to describe participant and~     disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma~     (MCL) participants in China.~   "
318|NCT03053011|"~     As part of developing a relay alarm project, the aim of the study is to test a sleeper's~     capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).~   "
319|NCT03052998|"~     Many studies have reported an association between epilepsy, including Nodding Syndrome (NS),~     and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted~     particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or~     insufficiently controlled with mass Ivermectin distribution. There is evidence that~     increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal~     evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy~     (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in~     these patients will have major consequences.~      Objective~      To assess whether Ivermectin treatment decreases the frequency of seizures and leads to~     seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate~     such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and~     that therefore we should increase our efforts to eliminate onchocerciasis.~      Methods~      We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to~     compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate~     Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants~     will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for~     epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during~     the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction~     compared to baseline seizure frequency. Reduction of seizures will be compared between~     Ivermectin and non-Ivermectin arms.~      Current status~      Start of enrolment is planned from March 2017 and we expect to have enrolled all 110~     participants by August 2017. Results are expected early 2018.~      Discussion~      If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or~     significantly reduces seizure frequency in OAE patients this will have major consequences~     for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free,~     and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of~     epilepsy will have a major impact on quality of life and socio-economic status of families~     with affected members in Africa.~   "
320|NCT03052985|"~     Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women~     Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital~     prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.~   "
321|NCT03052972|"~     This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451)~     in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals~     (BIOCARD) study at Johns Hopkins University.~   "
330|NCT03052855|"~     Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000~     suicide attempts every year. SB management is therefore a major public health issue.~      Evidence associated dysregulation of the serotonergic system and the~     hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these~     abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity.~     There is a need to better understand the physiopathology and develop diagnostic and~     therapeutic tools in SB.~      The investigators hypothesize that increased peripheral biomarkers of inflammation would~     correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA,~     especially in suicidal patients.~      Our aim is to compare rates of cerebral metabolites, in particular the complex~     glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior~     cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with~     and without suicidal attempt.~   "
322|NCT03052959|"~     The BETTER intervention consists of supportive meetings between a specially trained~     prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic~     disease prevention and screening activities (CDPS). The prevention practitioner nurse will~     assist participants to identify goals for accomplishing CDPS activities in the next 6~     months. Promotion, recruitment of participants and delivery of the BETTER intervention will~     be adapted to meet the needs of the residents through the use of participatory research~     methods and community engagement strategies. The study population consists of individuals~     aged 40-64 years living in 10 designated areas or clusters within Durham Region in Oshawa~     and Whitby.~      Objectives:~        1. Help people in the designated areas identify personal goals related to chronic disease~          prevention and screening activities.~        2. Evaluate whether the prevention practitioner was effective in helping people achieve~          their goals and explore whether this type of intervention could work in other settings.~        3. Share what the investigators learn with government and other public health units in~          Ontario and across Canada.~      Some clusters will receive the BETTER intervention right away and other clusters will be in~     a wait-list control group to receive the intervention 6 months later. Our main outcome is~     the change in a score that considers the number of preventive health items a person has~     achieved during the 6 months. The investigators will also be doing in-depth interviews and~     focus groups with health care providers, community organizations and people who live in the~     designated areas to understand whether the primary practitioner was effective.~   "
323|NCT03052946|"~     Randomized trial with a estimated number of 60 patients with mild or moderate anal~     incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of~     the University of São Paulo (HC-FMUSP).~        -  Exclusion criteria: symptoms of anal incontinence for less than six months, with severe~          anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy,~          evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel~          disease, malignant disease Congenital formation, scleroderma, Parkinson's disease,~          immunosuppression and ongoing gestation. In addition, those patients who do not agree~          to participate in the survey will be excluded.~        -  The study will have 4 phases: preoperative, surgical, recent postoperative and later~          postoperative~   "
324|NCT03052933|"~     COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment~     for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol,~     which would be expected to be feasible and effective in this group of patients.~      Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with~     sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in~     relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.~      Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell~     lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited~     extramedullary toxicities.~      Considering the evidence of activity for both agents against PTCLs, the investigators~     propose that targeted therapy with copanlisib in combination with gemcitabine will exhibit~     early elimination of rapidly growing tumor cells and be a rational therapeutic modality for~     use in relapsed or refractory PTCLs, if the overlapping toxicities can be managed.~   "
325|NCT03052920|"~     This longitudinal study evaluates the possible benefit of cochlear implantation in the poor~     ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better~     hearing ear.~   "
326|NCT03052907|"~     The investigators will expand BSPan's reach and sustainability by systematizing how to~     enable counties to assume responsibility for one or two of the components while~     Moncrief/uTSW continues to provide centralized financial review and reimbursement as the~     Texas BCCS contractor. The investigators will prospectively identify which counties have the~     necessary program capacity, then test whether implementation of BSPan tailored to a county's~     capacity and local needs can lead to equivalent program success in an additional 12 rural~     counties. Findings will be used to develop a model by which BSPan benefits can be brought to~     rural communities across the country.~      The investigators will use a readiness assessment criteria (RaC) to gauge county capacity~     and readiness for BSPan program implementation. The goal of our evaluation is to demonstrate~     whether a regional decentralized delivery (hub-and-spoke) model can be sustained and~     increase program reach to underserved rural women. The RaC tool serves two purposes: 1) to~     determine county capacity and 2) harness program data to facilitate communication during~     operations between a central BSPan hub and each county partner (spokes).~      Our evaluation will analyze county training and implementation of BSPan program components,~     and comprehensive screening processes of the hub and spoke model. The investigators will use~     county site visits and selected interviews of participants and staff to gain insight into~     factors at the participant and county levels that facilitate adoption and implementation of~     comprehensive screening processes, in conjunction with key quantitative metrics and process~     outcomes.~      The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan~     program component implementation in each county. Re-aiM specifies dimensions at the~     participant and organizational levels. Dimensions are defined as the intervention's: 1)~     Reach into the target population, 2) effectiveness in modifying risk, 3) adoption by target~     settings, 4) consistent implementation, and 5) Maintenance of its effects among participants~     and target settings. our mixed-methods approach will enable focus at both the individual and~     organizational levels and has been successfully used to assess other similar screening and~     health promotion programs.~   "
327|NCT03052894|"~     The objective of this study is to determine the accuracy of a hydraulically coupled twitch~     monitor compared to the kinemyographic twitch monitor in current use to measure the extent~     of neuromuscular blockade in patients undergoing general anesthesia.~   "
328|NCT03052881|"~     The purpose of the study is to determine whether use of a robotic system improves the~     precision and therefore safety of high precision steps in retinal surgery. Two common~     surgical scenarios (ERM/ILM peel and sub retinal haemorrhage displacement surgery) that~     require a high degree of precision to avoid damage to the retina have been chosen for this~     trial. These steps also have been selected because they allow a clearly definable outcome~     measure e.g. time taken to complete a specific step in the operation. The main issue here is~     that the patients will be undergoing this procedure regardless of enrolment in the trial -~     the only difference being that for study participants the surgeon will perform parts of the~     operation with the assistance of the robot.~   "
329|NCT03052868|"~     Data for this study will be obtained from the University of Texas Southwestern Medical~     Center Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons~     Cancer Center. One hundred female breast cancer patients who have completed adjuvant~     chemotherapy will be enrolled. In order to reach this number, it is estimated that up to 125~     eligible participants will need to be recruited. The study will last approximately two~     years. Participants will undergo one cognitive testing session, and each subject's total~     participation time will last no more than two hours.~   "
331|NCT03052842|"~     Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can~     effectively kill the bacteria in the oral cavity that cause dental caries..~   "
32464|NCT02632383|"~     A multicenter randomized controlled trial testing the app Young with Diabetes~   "
332|NCT03052829|"~     The benefits of regular physical activity are well-established. Furthermore, the~     investigators have previously shown that in a population of patients with implanted~     pacemakers, those who exercise more than 2 hours daily have improved survival compared with~     those who exercise less than 2 hours daily. In this study, the aim f the investigators is to~     determine whether the offering subjects with pacemakers who have low levels of physical~     activity at baseline counseling to increase physical activity levels is effective as~     measured by their implanted device as well as by an external pacemaker.~      The investigators seek to enroll about 30 patients into a 6-month 1:1 randomized~     interventional trial comparing the levels of physical activity in 2 groups, those who~     receive physical activity counseling versus usual care. The activity levels will be measured~     with external pedometers and with accelerometers embedded within the pacemaker device.~   "
333|NCT03052816|"~     The purpose of this randomized controlled trial is to determine whether, ICE-T, a novel~     multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and~     tylenol, has improved pain control intake compared to the standard postoperative pain~     regimen in patients undergoing vaginal pelvic floor reconstructive surgery.~   "
334|NCT03052803|"~     The aim of the study is to compare different devices available to measure fractional flow~     reserve (FFR) in coronary arteries.~   "
335|NCT03052790|"~     The purpose of this study is to compare the outcomes and accuracy of implant positioning in~     robotic assisted total knee arthroplasty with traditional manually instrumented total knee~     arthroplasty.~   "
336|NCT03052777|"~     This study evaluates the impact of a 12-week theory-based exercise telephone counselling~     program (versus a self-directed exercise group) on closing the exercise intention-behavior~     gap in a sample of hematologic cancer survivors.~   "
337|NCT03052764|"~     This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®),~     compared to placebo, when injected into the bladder using an alternative injection paradigm~     in reducing the number of daily urinary incontinence episodes in patients with overactive~     bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with~     an anticholinergic.~   "
338|NCT03052751|"~     The purpose of the study is to evaluate the clinical efficacy of UCB7665 as an on-demand~     treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate~     to severe.~   "
339|NCT03052738|"~     This study proposes to do a prospective observational cohort study evaluating the quality of~     life (QOL) of children with Central Nervous System (CNS) tumors and their families who~     choose to self-medicate with marijuana-derived products while undergoing treatment at~     Children's Hospital Colorado (CHCO).~   "
340|NCT03052725|"~     This is a multicenter, open-label (OL) extension study to obtain additional long-term safety~     data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed~     dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who~     completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The~     study consists of a screening/baseline visit followed by a 36-week OL treatment period and a~     15-week follow-up period.~   "
341|NCT03052712|"~     The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's~     disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic~     brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers~     to a large group of emotional and cognitive abilities regulating inter-individuals~     relationships and it includes mainly theory of mind, emotional information processing and~     empathy. However, assessment of socio-emotional processes is still largely based on~     experimental tests that are not validated for clinical purpose. In addition their long~     duration of administration is not adapted to clinical examination. Finally these tests have~     not been standardized and normalized in French-speaking population.~   "
342|NCT03052699|"~     This database has for objective to include the medical data of patients which underwent a~     vaginal Cesarean Section in our establishment. This collection will allow to determine the~     risk factors of the maternal morbi-mortality and to estimate the long-term results~   "
343|NCT03052686|"~     This study has for objective to collect medical data from patients with uterine rupture at~     the childbirth.~   "
344|NCT03052673|"~     The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve~     gastrectomy are collectively covered under the term `bariatric surgery`. The growth of~     bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure~     patient safety and facilitate post-surgery outcome. Conventionally, balanced general~     anaesthesia techniques routinely use opioids peri-operatively for intra-operative~     haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese~     patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the~     same technique when employed in the morbidly obese patients hampers early and intermediate~     postoperative recovery due to the occurrence of side effects, such as, sedation, PONV,~     respiratory depression, depressed GI-mobility. The above stated side effects, have lead to~     increased propensity for postoperative cardiac and pulmonary complications. Obese patients~     are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be~     employed judiciously in these patients. On the other hand, the reduction in opioid use may~     result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore,~     we need to minimise opioid use and employ some other drugs which besides having analgesia,~     has a opioid-sparing effect also.~      Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in~     sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic,~     anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a~     key advantage of ketamine is that it can reduces post-operative pain and use of opioid when~     used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely~     to decrease opioid-related postoperative morbidity in these patients undergoing bariatric~     surgery.In view of the above, a clinical research is highly desirable to study techniques to~     decrease the use of opioids in obese surgical patients.This prospective randomised two-arm~     study aims to assess the effect of low-dose ketamine on postoperative pain relief and~     opioid-sparing ability in obese patients undergoing bariatric surgery.~   "
345|NCT03052660|"~     We aim to assess, if placebo compared to preoperative administration of midazolam in elderly~     patients is equal in regard to the global postoperative patient satisfaction~   "
346|NCT03052647|"~     The objective of this study was to compare the an adhesive latch device ( Dermaclip) to~     subcuticular skin closure at the time of cesarean section. Currently, no studies exist~     comparing these two closure techniques. The hypothesis is dermaclip closure is faster than~     subcuticular closure. The null hypothesis is there is no difference in closure times. There~     is a study (see reference at bottom) that compares staples closure to subcuticular closure,~     but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed~     and is expected to be as fast as staples closure compared to subcuticular as noted in the~     prior study referenced below.~   "
347|NCT03052634|"~     A significance,safety and pharmacokinetic of open-label and multicentric Phase Ib/II Study~     of RC48-ADC Administered Subcutaneously to Subjects With HER2-Positive in Advanced Breast~     Cancer~   "
348|NCT03052621|"~     Locally advance breast cancer and extensive locoregional recurrence are still considered as~     complexity of reconstruction. Although previous studies concluded that omental transposition~     was considerably indicated in poor vascularity in irradiated tissue, secondary infection and~     large defect become the obstacles of local tissue flaps. While some centres showed the~     excellent healing of omental transposition. Meanwhile, many studies showed the preferable~     outcome in escalating radiotherapy in term of locoregional control. In the investigators'~     institute, omental transposition in breast cancer has been developed for twenty years. The~     only institute in Thailand enhanced using this procedure in order to closure of large~     primary breast cancer and chest wall recurrence. This procedure is undertaken by single~     surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including~     preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of~     breast cancer centre committee, and meticulous wound care including vacuum assisted wound~     dressing, non-adhesive dressing. As a result, survival time could be improved.~   "
349|NCT03052608|"~     A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to~     crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC~     patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to~     overall survival in the same population~   "
350|NCT03052595|"~     Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central~     nervous system (CNS) and is one of the most common neurological diseases, often leading to~     disability of the patients. The MS pathogenesis includes vascular and inflammatory~     components, however recently also the role of mitochondrial dysfunction being a hot topic in~     neurodegeneration.~   "
351|NCT03052582|"~     The aim of the project is to investigate the effects in humans of a daily intake of whole~     milk compared to skimmed milk primarily and secondarily respectively on:~        -  Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides~        -  Risk markers of diabetes type 2: plasma glucose and insulin~   "
352|NCT03052569|"~     Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations~     who have not received TKIs that target RET alterations, who do not qualify for participation~     in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.~   "
353|NCT03052556|"~     Background The main risk factor for cervical cancer is the infection by human papillomavirus~     (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical~     screening with pap smear test and HPV vaccination are effective preventions. A high~     frequency of HPV carriage and of cervical dysplasia have been described in transplanted~     women.~      The majority of women with cystic fibrosis reach adulthood and some will face~     transplantation. Particular attention should therefore be paid to cervical screening.~     However, low adherence to screening recommendations was noted. In addition, preliminary data~     has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in~     women with cystic fibrosis.~      Objectives of the study The main objective of the study is to determine the prevalence of~     HPV carriage in a cohort of women with cystic fibrosis~      The secondary objectives are:~        -  To study the factors associated with the prevalence of HPV (transplantation, smoking,~          age at first intercourse, number of sexual partners in the year, contraception,~          gravidity and parity, HPV vaccination)~        -  To describe and to compare with data in the general population, in hospital-based~          population, (and with data in transplanted population for transplanted women)~             1. the prevalence of HPV (and of different genotypes) infection, of cervical~               dysplasia, of vulvar/vaginal/cervical condylomatosis~             2. the rate of HPV persistence (> 12 months), the mean time of HPV clearance; rates~               of spontaneous regression / persistence / worsening of cervical dysplasia~      Study design:~      The study will last 24 months. Includable patients are adult women, transplanted or not,~     followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap~     smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection~     of 35 different HPV genotypes will be performed.~      Patients with an initial abnormal pap smear or a positive HPV test will be monitored:~        -  In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will~          be renewed every 6 months during the study period~        -  In case of an abnormal smear:~      Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on~     the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade~     squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL),~     Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC)~     , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed~      Expected results This study will help to determine the frequency of HPV infection and the~     pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis~     This data will help to sensitize health professionals on the importance of gynecological~     care and regular cervical screening, and on the importance of HPV vaccination.~      In case of a high frequency of genital diseases linked to HPV, recommendations on~     gynecological monitoring procedures for women with cystic fibrosis could evolve.~   "
354|NCT03052543|"~     This pilot study is being conducted to determine whether the intraoperative presence of a~     Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and~     postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to~     the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in~     adult and pediatric studies it has been shown to decrease time to emergence, decrease~     volatile anesthesia requirement, decrease recovery time and in some cases, decrease~     post-operative morbidity (REFS). The effect on intra-operative and post-operative~     parameters, when BIS is present but not specifically designated to be used as a monitor to~     guide anesthesia delivery, has not been specifically examined. This will be the first~     pediatric study which applies BIS on all patients and randomizes the anesthesiologists to~     either be or not be privy to seeing the BIS values during intra-operative period.~   "
355|NCT03052530|"~     A prospective, open label, multi-center, single arm, observational study designed to~     evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25~     mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts~     during percutaneous coronary intervention.~      Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters~     1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts~     during their index procedure. All subjects will be screened according to the protocol~     inclusion and exclusion criteria and will be followed through hospital discharge.~   "
356|NCT03052517|"~     This study is a 2-treatment period, randomized, multicenter parallel-group study. The~     overall purpose of this study is to provide long- term safety data for fevipiprant (QAW039)~     (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma~     (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with~     moderate-to- severe asthma.~   "
357|NCT03052504|"~     The study will examine which differences there are in comorbidity and complications~     collected retrospectively from medical records compared with data collected prospectively in~     two groups of patients undergoing either radical cystectomy or radical nephrectomy.~      Hypothesis is that he prevalence of registered comorbidity and minor complications in~     patients who have undergone radical cystectomy or nephrectomy, will increase if the data~     collection is focused and prospective, compared with retrospectively collected data.~      The study will be conducted as a single-blind randomized controlled trial. Patients included~     in the study will be randomized to either control or intervention in the ratio 1:1. There~     are two groups of patients: Patients admitted to radical cystectomy and patients admitted to~     radical nephrectomy, due to cancer.~   "
358|NCT03052491|"~     This open-label field trial evaluates the effects of treatment with a multi-pathway dietary~     supplement (Stem Cell 100+) that has been commercially available for several years. The~     objective of the intervention trial is to determine if normal subjects over 35 years of age~     experience any observable health benefits from the dietary supplement as to their blood~     pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported~     changes in markers of overall health and life expectancy.~   "
359|NCT03052478|"~     There is no accepted standard therapy for patients with advanced gastric cancer who have~     progressed during or after second-line therapy. The role of 3rd line treatment in advanced~     gastric cancer has not been proven.~      As a novel target of gastric cancer, SMO overexpression is chosen in this study, and the~     investigators plan this study to evaluate the efficacy and safety of vismodegib in gastric~     cancer. The doses of vismodegib are based on trials of basal cell carcinoma.~   "
360|NCT03052465|"~     Crohn's disease (CD) is becoming more common. One of the main features of this disease is~     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems~     have a strong negative effect on the patients' quality of life but the causes of these~     problems are not well understood. Enteroendocrine cells are nutrient sensors in the bowel~     that secrete special chemicals (called hormones) that control appetite and the movements all~     the gut. The investigators think that this control mechanism goes wrong in Crohn's patients~     and they have set off to do more research on this. Looking at the inside work of the gut has~     always been difficult and at times unpleasant for patients, however recent developments in~     magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the~     gut in greater detail and without discomfort for the patients.~      Our main objective is to investigate the difference in small bowel motility between CD~     patients with active ileal disease and healthy volunteers.~   "
361|NCT03052452|"~     The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in~     tracking their food intake and linking diet to symptoms.~      The investigators will test this app for developmental purposes among a sample of 100~     participants who are patients of dieticians at Cedars-Sinai Medical Center (CSMC) and the~     University of Michigan (UM) with varying presentation of GI symptoms and suspected food~     intolerances. The MNH app will be used as a data collection platform for this study and can~     be utilized by any device supporting iOS (tablets, ipads, iphones, and Android. The~     investigators will use the data collected in the app testing to develop population level~     FAST scores.~      The MNH app includes two integrated functions:~        1. Patient Symptom and Food Consumption Reporting~        2. FAST Score calculation It is important to note that, per this protocol, the MNH app~          will only be evaluated for developmental purposes. It is currently not meant to serve~          as a diagnostic tool, nor to provide referrals for patients with food and symptom~          patterns that may suggest a food intolerance. In this respect, our test app is not~          governed by FDA or other regulatory bodies, as it does not make diagnoses or offer~          specific guidance. The purpose of this study is only to develop normative scoring~          distributions of FAST within the context of patients visiting GI dieticians as part of~          routine care.~   "
362|NCT03052439|"~     Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of~     the US population and up to 20% of the population worldwide. This is a condition that is~     diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as~     the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea,~     abdominal cramping, and bloating, it also significantly affects quality of life, overall~     functioning, and work productivity.~      The cause of IBS is likely multifactorial, which makes it a difficult disease to treat.~     However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS~     patients restrict their diet to prevent or improve their symptoms, and patients are~     increasingly interested in more holistic approaches to disease management. At present, the~     most persuasive evidence that dietary changes can treat IBS supports a diet low in~     fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and~     polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve~     IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and~     quite restrictive. In addition, this diet is not meant to be used as a maintenance diet;~     patients undergo an elimination phase followed by a reintroduction phase of specific~     carbohydrate groups as they monitor their symptoms. From the results of our proposed study,~     the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP~     diet that is equally effective, and also create a standard protocol that patients can use~     during this reintroduction phase.~      Patients with non-constipated IBS will be recruited into a 12-week trial that would help~     determine the optimal way in which high FODMAP foods should be introduced. After consent,~     patients would start on a low FODMAP diet for 14 days, and if their symptoms improve, they~     would be invited to continue in the study and enter the reintroduction period. During this~     period, subjects would introduce different groups of FODMAPs in a blinded fashion while~     remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms. At the end of~     the study period, subjects would be informed of the FODMAPs to which they were sensitive and~     would meet with a dietitian. At the completion of the study, the investigators would compile~     the data and determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus~     providing the construct for a modified low FODMAP diet, or low FODMAP-Light. It is hoped~     that this modified, less restrictive version of the low FODMAP diet would be equally~     effective for the majority of IBS patients.~   "
363|NCT03052426|"~     The aim of this study is to combat the growing global health issue of sedentary behavior and~     the associated health consequences of prolonged sitting in the workplace. The population of~     desk-based workers makes up a relatively large population and are an important target for~     this health promoting initiative with a focus on improving posture, encouraging movement,~     and fostering a more active and healthy business community. It's important to recognize that~     occupational therapy practitioners can contribute to community health promotion/disease~     prevention programs by the skill-set of practitioners to understand habits and routines that~     influence the adoption and maintenance of healthy behaviors.~   "
364|NCT03052413|"~     The objective of this study is to assess the safety and effectiveness of a nutraceutical~     supplement for the treatment of hair loss and thinning in females over the course of six~     months of continuous daily use.~   "
365|NCT03052400|"~     Randomized, double blind, placebo-controlled clinical trial examining the efficacy and~     safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not~     associated with Cushing's syndrome, and sub-optimally controlled on oral anti-hyperglycemic~     agents~   "
366|NCT03052387|"~     Using autogenous Chin block for vertical augmentation with simultaneous implant placement at~     anterior maxilla region comparing between the Onlay and Inlay grafting techniques.~   "
504|NCT03050580|"~     This is cluster randomized control trial, that aims to evaluate the effectiveness of the~     treatment group model for abused women in enhancing their self-esteem and reducing the level~     of depression, in three shelters for abused women of Po Leung Kuk (a social service~     organization in Hong Kong). It is hypothesized that subjects in the Treatment Group would~     report significant improvement in self-esteem, social support, quality of life; reduction in~     the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service~     delivery.~   "
367|NCT03052374|"~     Postpartum depression (PPD) is a major public health issue. Known as the thief that steals~     motherhood since symptoms obstruct a mother's capacity for understanding and enjoying her~     baby, PPD affects approximately 1 in 5 moms. Built via serve and return interactions (e.g.~     baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for~     healthy child development but are diminished by PPD, resulting in interactions that place~     children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful;~     stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress~     hormone (cortisol) release, which, in turn, negatively affects developing infant brains by~     decreasing brain volume. Infants' critical periods of brain development are vulnerable to~     long-term effects of cortisol, explaining some of the problematic developmental outcomes~     observed in children of depressed mothers.~      How can the investigators support depressed mothers and their infants? Successfully treating~     PPD does not always benefit mother-child relationships; however, this research builds on a~     successful pilot that demonstrated that nurse-guided video feedback improved mother-infant~     interactions in the context of PPD. By improving interaction quality, depressed mothers may~     be motivated to engage in more play and, in turn, infants who appear interested and ready to~     interact are more likely to elicit positive, enjoyable experiences from mothers. Building on~     the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback~     Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants)~     on maternal-infant interaction and infant cortisol patterns as well as infant development,~     maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful,~     future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health;~     and 2) commercialize VID-KIDS for dissemination.~   "
368|NCT03052361|"~     The investigators aim to assess whether ondansetron given at triage can reduce the number of~     patients requiring emergency department observation in children with acute gastroenteritis.~     The investigators will also assess the improvement of patient comfort and total length of~     stay~   "
369|NCT03052348|"~     Staphylococcus Aureus is a common pathogen colonising the skin of Atopic Dermatitis patients~     and is responsible for the frequent relapses and complications associated with the disease.~     Synalar cream; Supiroban 2% and Cetamacrogol, are frequently used separately in the~     treatment of AD. However the use of Supiroban 2%, in a mixture of Synalar cream and~     Cetamacrogol cream as a combined formulation, has not been studied in children suffering~     from severe AD. The aim of this trial is to determine the efficacy of combination therapy~     which includes a topical antibiotic, a topical steroid cream and a moisturizing cream over a~     3 to 4 month period in children.~      Trial Design: A two-center, single blinded, randomized parallel group, superiority trial.~      Type of control: Active controls without placebo~      Study population and Setting:~      A sample of 44 subjects will be recruited from Red Cross Children's Hospital and Umtata~     Hospital.~      Estimated duration of trial: 6 months.~      Duration of participation: Each subject will participate in the trial for a maximum of 90~     days.~      Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and~     improvement in the quality of life at 90 days.~      Benefit/Significance~      A simple and effective approach to the management of atopic eczema.~   "
370|NCT03052335|"~     Main objective is to improve colorectal cancer (CRC) screening programme in the Czech~     Republic and decrease the disease incidence and mortality. The secondary aim is to verify~     the effectiveness of incorporation of the new minimally invasive device in the prevention~     programme.~   "
371|NCT03052322|"~     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022~     and Humira® in adult subjects with rheumatoid arthritis.~   "
372|NCT03052309|"~     The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and~     clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical~     practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in~     popliteal arteries~   "
373|NCT03052296|"~     The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and~     clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long~     atherosclerotic femoropoliteal artery lesions in daily clinical practice~   "
374|NCT03052283|"~     Development, validation and evaluation of a new multimodal questionnaire to assess and~     quantify the abdominal involvement in patients with the inherited life shortening~     multi-organ disease Cystic fibrosis.~   "
375|NCT03052270|"~     1. This will be a randomized prospective and open-label study with no placebo control or~          blinding of the participants and the research team members. The study is to compare the~          effectiveness of vaginal progesterone versus combination of vaginal progesterone and~          Arabin cervical pessary in the prevention of preterm delivery among patients with~          incidental shortened cervical length.~        2. As part of standard clinical care, all pregnant patients usually have cervical length~          measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the~          GE ultrasound Volusion 8 using the vaginal probe.~             1. Patients with short cervix will be counseled and offered the opportunity to~               participate in the study.~             2. All participants will be taught how to use the vaginal progesterone once daily~               prior to bedtime. In addition, those in the combination group will have the~               cervical pessary placed in the clinic right away or within a week if they request~               for more time to brood over their diagnosis and weigh on the option of inserting~               Arabin pessary.~             3. All participants will be followed up in the high-risk obstetric clinic as per~               standard prenatal care. Frequency of follow up visits will be individualized~               depending on patient's need and comorbidities. , Participants will be requested to~               bring the remnant of the vaginal progesterone to the clinic to assess compliance.~             4. Participants in the study will continue their prenatal care with UIC high-risk~               obstetric clinic until delivery.~             5. The study recruitment will occur for a period of 2 years starting from November~               2016 to October 2018 or until all the anticipated numbers of study subjects have~               been attained.~             6. There will be 10 % over-sampling to cater for those who will drop out from the~               study or loss to follow up after randomization, and those who delivered in another~               hospital.~             7. Participants will have access to one of the investigators or the high- risk clinic~               nurse for any complaints related to their conditions.~             8. Participants can opt out at any stage of the study if they do not want to continue~               further or if there are any adverse effects.~   "
376|NCT03052257|"~     The proposed study is a randomized controlled trial enrolling Veterans with medically~     treated glaucoma who report less than 100% adherence to the prescribed glaucoma therapy.~     Participants will be randomized to receive either a one-on-one session with a member of the~     research team discussing the disease process and strategies for administering eye drops~     (intervention) or a one-on-one session with a member of the research team discussing general~     eye health (control). All participants will be provided with a smart bottle to house their~     glaucoma medications. The smart bottle records the date and time that the bottle is opened.~     For participants in the intervention arm only, a reminder function will be activated. The~     proportion or prescribed doses taken according to the monitor will be compared for the two~     groups.~   "
377|NCT03052244|"~     Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be~     applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS~     treatment will be coupled with a video of a man walking (creating a visual illusion) in~     order to enhance functional ability and reduce pain~   "
512|NCT03050476|"~     Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute~     kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.~   "
34229|NCT02609035|"~     ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to~     improve~   "
378|NCT03052231|"~     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains~     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic~     saline. Programs to enhance adherence, including comprehensive behavioral interventions with~     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,~     and data capture technology offer the potential for enhancing adherence by providing~     immediate and more frequent feedback to the patient regarding his or her fidelity to the~     prescribed treatment regimen. The investigators propose to evaluate a systematic yet~     technically simple approach to linking treatment and feedback components to enhance~     adherence in a real-work CF clinic setting that treats a significant minority patient~     population.~      This is the first trial assessing the impact of a collaborative active intervention program~     of a multi disciplinary team in improving adherence to specific chronic medications and~     improving clinical outcomes in CF patients. The PI has implemented the texting service~     (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide~     both English and Spanish language content relevant to these participants and their standard~     treatment protocols.~   "
379|NCT03052218|"~     Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice~     per hour in children having received tramadol as a pain killer as part of his/her routine~     care.~      Pupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score~   "
380|NCT03052205|"~     This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate~     promising clinical or biological activity.~   "
381|NCT03052192|"~     In this study, the investigators will investigate and characterize acute medical patients in~     order to optimize patient courses in the acute care departments, especially with regard to~     polypharmacy and undernourishment. In addition, the investigators will investigate~     underlying immunological mechanisms of chronic inflammation and biological aging in this~     population to improve the current knowledge and possibilities for preventing chronic~     diseases and acute hospitalization.~   "
382|NCT03052179|"~     Oral Lichen Planus (OLP) is an inflammatory disease of mucosal and skin with unknown~     etiology. The prevalence rate in England is reported to be between 1-2.4%. OLP contributed~     to around 40% of all visits or 1,200 appointments in 2014 at the Eastman Dental Hospital.~     Pain, discomfort, long-standing use of medications, lesion recurrence and adverse side~     effects of therapy are commonly associated with OLP, eventually leading to a significant~     reduction in a patient quality of life. In addition, there is also increased risk of~     developing oral cancer in patients with OLP. The current gold standard treatment for OLP is~     corticosteroid, which can result in adverse side effects including increased risk of~     infections and skin cancer, reduced systemic immune system, and hepatotoxicity with~     long-term usage.~      Alternatively, a probiotic food supplement, VSL#3, has shown evidence of been able to induce~     and maintain remission in Intestinal Bowel Disease (IBD), with no adverse effect a part than~     bloating, reported. Additionally, a preliminary report shown that probiotics treatment in~     Behcet's disease and Recurrent Aphthous Stomatitis (RAS) lesion resulted in reducing the~     number of oral ulcerations and subjective relief of oral discomfort.~      Investigator designed a clinical trial with 30 participants allocated to one of two~     interventions, VSL#3 or placebo. Individuals with biopsy-confirmed OLP who experience~     painful symptoms will be recruited from a single site research site (Eastman Dental Hospital~     (EDH)). Either the active VSL#3 or the placebo, provided by Ferring Pharmaceuticals Limited,~     will be consume twice a day over a 30 days period. Questionnaires that will determine pain~     levels, disease activity and quality of life will be completed before the study begins, on~     days 15, 30 and 30 days after the last supplement intake. In addition saliva and blood~     samples will be taken before therapy begin, at 30 days of therapy, and 30 days after the~     last supplement intake. The levels of pro-inflammatory cytokines and the oral microbiota~     will be investigated using these samples. A blinded clinician will assess the clinical~     effects between groups of active VSL #3 and placebo and the results will analyze by~     statistician.~   "
383|NCT03052166|"~     Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed~     ultrasound plane waves through the breast, as well as collects reflected ultrasound output.~     As the patient lays prone on a table, the breast is submerged in a warm water bath. The~     transmitter and receiver assembly moves around the suspended breast to record data for~     successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear~     transducer's array encircle the breast to gather data from the tissue structures of the~     breast, from nipple to chest wall. Information gathered from this automated QT scan~     encompasses the entire breast which is currently not commercially available using any other~     ultrasound technology.~   "
384|NCT03052153|"~     This study will evaluate if an association exists between levels of blood flow through the~     pulmonary veins and the incidence of graft dysfunction post operatively.~   "
385|NCT03052140|"~     Single-blind, randomised, single centre, 2-way crossover study to collect post-market~     clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.~   "
386|NCT03052127|"~     The primary objective is to assess the safety, immunogenicity and preliminary efficacy of a~     single treatment of one of two dose levels of Light-activated AU-011 for the treatment of~     subjects with primary choroidal melanoma.~   "
387|NCT03052114|"~     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can~     produce reproducible and accurate images in people with stroke or head injury compared to~     existing standards such as MRI, CT.~      Electrical Impedance Tomography is a relatively new medical imaging method, which has the~     potential to provide novel images of brain function. It is fast, portable, safe and~     inexpensive, but currently has a relatively poor spatial resolution. It produces images of~     the internal electrical impedance of a subject with stroke or head injury using rings of ECG~     like electrodes on the skin. EIT recording will take place as early as possible, usually~     within 24 hours of admission. Following completion of the recording, the EIT images will~     subsequently be analysed and compared to other imaging data for accuracy.~   "
388|NCT03052101|"~     The aim of this study is to conduct survey-based assessments for the safety of air travel in~     patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients~     through the clinic network at Rare Lung Disease Consortium (RLDC) and through the~     Histiocytosis Association website. Patients will have access to the questionnaire via REDCap~     (an online data management system) and each patient will be provided with a link to complete~     the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the~     purpose of this study. Secondary aims of this study include further characterization of the~     clinical aspects of disease and to establish a contact registry for these patients, in order~     to facilitate future studies.~   "
513|NCT03050463|"~     The investigators hope to gain a better understanding of the influence of affect reactivity~     and regulation on the decision of newly diagnosed breast cancer patients to choose bilateral~     mastectomy. The information gained can help develop an intervention to enable management of~     cancer-related anxiety by non-surgical means.~   "
389|NCT03052088|"~     This is a prospective clinical validation study of a novel regulatory approved (CE-IVD)~     diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study~     aims to externally validate the tool's diagnostic accuracy and estimate the potential~     improvement in health and economic outcomes following the usage of ImmunoXpert™.~     Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to~     current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of~     requisition. Enrolled patients will be managed according to the current standard of care and~     per standard institutional procedures.~   "
390|NCT03052075|"~     The primary objective of this study is to estimate the percent change in baseline bone~     mineral density (BMD) starting at one year after parathyroidectomy and all the following~     available dates in patients presenting with primary hyperparathyroidism. The secondary~     objective is to identify patient factors associated with change in BMD.~   "
391|NCT03052062|"~     The objectives of this clinical study are to determine the tolerance of dietary supplement~     Lipidrive through the evaluation of several parameters :~        -  Various blood biological parameters~        -  Urinary parameters~        -  Hemodynamic indicators~        -  Cardiac function~        -  Anthropometric variables~   "
392|NCT03052049|"~     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate~     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to~     benign prostatic hyperplasia (BPH).~   "
393|NCT03052036|"~     SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting~     with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to~     compare time to cardiovascular death or non-fatal MI within one year from randomization.~   "
394|NCT03052023|"~     This study designed to compare the new laparoscopic dual approach to inguinal hernia repair~     with trans-abdominal prepreitonal (TAPP) and lichtenstien repair (open procedure)~   "
395|NCT03052010|"~     An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention~     methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure~     prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy~     will be introduced into 24 public HIV-1 care centers in central and western Kenya according~     to national guidelines using a stepped wedge design, stratified by region.~   "
396|NCT03051997|"~     The purpose of this study is to test a prize-based contingency management intervention for~     increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and~     for achieving the ultimate outcomes of reduced substance use and delinquent behavior among~     drug court-involved youth.~   "
397|NCT03051984|"~     Total knee replacement, or arthroplasty, is the final clinical intervention available to~     relieve pain and functional limitations related to advanced stage knee osteoarthritis.~     Despite its beneficial effects, the early post-surgical period is characterized by the~     erosion of lower extremity muscle size and strength that cause further disability and slow~     functional recovery. While the detrimental effects of this period on muscle are widely~     recognized, the mechanisms underlying these adaptations are poorly understood and there are~     currently no widely-accepted clinical interventions to counter them~   "
398|NCT03051971|"~     Delivery of inhaled short-acting bronchodilators (SABD) is standard of care in the emergency~     department (ED) for exacerbation of COPD, the goal of such being rapid reversal of airflow~     obstruction. However, current guidelines for the delivery of SABDs in spontaneously~     breathing patients make no distinction whether these medications should be delivered via~     metered dose inhaler (MDI) or jet nebulizer (JN), the specific medication delivery device~     having no significant effect on hospital admission or reversal of flow obstruction. However,~     advancements in nebulizer design, namely FDA-approved vibrating mesh technology, have~     demonstrated significant improvements relative to JNs and metered dose inhalers in~     efficiency and amount of drug delivered in in vivo and in vitro studies. Currently there are~     no clinical trials comparing the use of vibrating mesh nebulizers (VMN) to JNs and their~     effect on clinically important outcomes. This prospective randomized controlled pilot trial~     seeks to determine if there are differences in hospital admission due to COPD when a~     vibrating mesh nebulizer is used versus a jet nebulizer.~   "
399|NCT03051958|"~     Atopic dermatitis (AD) is highly prevalent and leads to suffering for the individual,~     increased risk of depressive symptoms and anxiety, and high societal costs. A few~     psychological treatment have been tested for AD, but to our knowledge none of them have been~     built on recently developed methods for optimizing exposure treatment. In addition, access~     to psychological treatment is limited and there is a need for new methods that could be~     easily disseminated. One possible solution to this problem is to deliver psychological~     treatment via the Internet, which has been tested in more than 100 randomized trials with~     good results for other clinical disorders than AD. The aim of this study was to test the~     effects of Internet-delivered mindfulness and exposure treatment (I-MET) for AD in a~     randomized controlled trial. We hypothesized that I-MET would lead to larger reductions of~     AD symptoms as well as psychological symptoms compared to treatment as usual.~   "
400|NCT03051945|"~     Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in~     humans.~   "
401|NCT03051932|"~     This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100~     patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be~     randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100~     mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.~   "
402|NCT03051919|"~     Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with~     acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement~     methods are used.~   "
412|NCT03051789|"~     A 4-armed cluster randomised controlled trial conducted among secondary schoolgirls in~     Siaya, western Kenya, where clusters are the unit of allocation and schoolgirls the unit of~     measurement. The overall aim of the trial is to inform evidence-based policy to develop~     intervention programmes which improve adolescent girls' health, school equity and~     life-chances. The primary objective is to determine the impact of menstrual cups or cash~     transfer alone, or in combination, compared against controls, on a composite of deleterious~     outcomes (HIV, HSV-2 infection, and school dropout) over 3 schoolyears follow-up.~   "
632|NCT03048903|"~     Random grouping by computer, divided into two groups, a group of rhubarb treatment group,~     another group for the placebo group.~   "
403|NCT03051906|"~     In over 60% of cases, squamous cell carcinoma of the head and neck (SCCHN) is discovered at~     a loco-regionally advanced stage that requires a combined multimodal strategy in order to~     pursue a curative intent. Bonner et al demonstrated that the combination of radiation (RT)~     with Cetuximab (CTX), a chimeric mouse IgG1 monoclonal anti-EGFR antibody, results in better~     median locoregional control and overall survival compared with RT alone without an increased~     rate of > G3 acute toxicity or detrimental effect on compliance and quality of life.~     However, subsequent negative trials (RTOG 0522) led to the hypothesis that in unselected~     patient populations the benefit of CTX may be diluted due to the molecular heterogeneity of~     SSCHN. Moreover, the absence of biomarkers predictive of response to anti-EGFR treatment may~     in part be explained by the observation that other factors play a role in favoring its~     anticancer effect, namely immunologic mechanisms. It has been demonstrated that SCCHN is an~     immunosuppressive disease characterized by prominent immuno-escape mechanisms, such as~     induction of a tumor-permissive cytokine profile and qualitative/quantitative lymphocyte~     deficiencies, occurrence of anergy in major immune effector cells and poor antigen~     presentation. Given these observations, it has been postulated that SCCHN may benefit from~     immunotherapeutic strategies, primarily aimed at PD-L1/PD1 checkpoint blockade. Segal et al~     (Asco 2015) reported preliminary results on the use of Durvalumab in pretreated patients~     with recurrent/metastatic SCCHN. Durvalumab is a humanized monoclonal IgG1 antibody that~     blocks PD-L1 binding to PD-1 and CD80 with high affinity and selectivity, thereby promoting~     activity of tumor-specific effector T cells and global anti-tumor immune response. Out of 64~     treated patients, 51 patients were available for the preliminary efficacy analysis:~     promisingly, the overall response rate was 12% (25% in PD-L1 positive patients). To date, no~     clinical trial, specifically designed for SCCHN, testing PD-L1 targeted agents has been~     completed, nor have been initiated combination strategies of CTX, RT and PD1/PD-L1~     antibodies in the curative setting. Taken all data together, a strong rationale may support~     the combination of Durvalumab, anti-EGFR therapy such as CTX and RT in order to revert the~     SCCHN-induced immune suppression and maximize treatment efficacy, ultimately through~     enhanced, CTX-mediated immune mechanisms and maximized RT-specific cytotoxicity.~   "
404|NCT03051893|"~     This was an open label, randomised, single dose study, comprising Part A (undertaken in two~     separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one~     four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers.~     The washout interval in both Part A and Part B was 1-week in between each treatment period.~   "
405|NCT03051880|"~     The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for~     dermatologic adverse events related to EGFR inhibitors.~   "
406|NCT03051867|"~     The purpose of the present study is to understand the effect of pregnancy on vitamin D~     metabolism and requirements as well as the modulatory role of the placenta in vitamin D~     metabolism during pregnancy. In addition, a human placental cell culture model will be~     employed to examine vitamin D metabolic flux in human trophoblast cells. The impact of~     maternal vitamin D status on maternal and fetal bone health during gestation will also be~     examined.~   "
407|NCT03051854|"~     Beside the home, the school is often the second important setting for the development and~     education of children and adolescents. Students spend a large part of their life at school.~     However, there is recurrent occurrence of violence against children and of harsh discipline~     measures used in home and school settings. These may result into negative consequences.~     Hence, prevention strategies against the use of harsh discipline use in schools become a~     priority.~      In the baseline of this study the investigators will therefore examine the prevalence and~     consequences of violence against children in Southwestern Uganda. The study will be~     conducted in schools and common disciplinary measures used by teachers, and the perceptions~     of teachers' and students' in relation to commonly used and experienced disciplinary~     measures we will be investigated.~      In the second phase, the investigators then will implement and assess the effectiveness of~     an intervention aimed at reducing the use of harsh and violent disciplinary measures in~     schools. ICC-T training in the long-term aims at fostering better relations amongst students~     and teachers. Based on feasibility studies, ICC-T intervention is expected to result into~     better teacher-student relationships, change in teachers' attitudes and behaviors concerning~     the use of violent disciplinary measures in the school setting.~   "
408|NCT03051841|"~     This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT),~     safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination~     with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.~   "
409|NCT03051828|"~     The data collection of physical evaluations after regular practice of the fencing at~     patients having surgically been treated for breast cancer highlighted encouraging results~     both on the functional drawing, and on the improvement of the quality of life.~   "
410|NCT03051815|"~     Apart from obesity, craniofacial factors are well recognized in the pathogenesis of~     obstructive sleep apnea (OSA) and are likely to play an important role in influencing the~     response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged~     Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much~     lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of~     OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial~     bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway~     have shown that a shorter distance between maxillary projection from the cranial base, a~     smaller posterior airway space, less mandibular protrusion, a narrower space between the~     hard palate and cranial base, and a more caudally placed hyoid bone predispose to a higher~     apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as~     measured by lateral cephalometry was associated with a greater fall in AHI after weight~     loss. Another study using craniofacial computed tomography (CT) scans to evaluate the~     maxillomandibular bony volume found that craniofacial restriction influenced the~     relationship between weight loss and OSA improvement. Collectively, these studies suggest~     that the effect on AHI with weight loss is likely to be more pronounced in those with a~     smaller craniofacial skeleton. However, the effect of the craniofacial restriction on the~     degree of rebound in OSA following weight gain after the weight loss intervention is~     unknown.~      The study aims to investigate the change in weight and OSA severity following cessation of a~     lifestyle modification program (LMP) and examine the relationship between craniofacial~     restriction and the degree of OSA reoccurrence.~   "
411|NCT03051802|"~     The scope of this clinical trial is to assess the clinical feasibility of this procedure,~     optimize the protocol and perform an initial comparison of the positional accuracy of~     navigated endoscopy and applicator insertion versus the standard of care 2D fluoroscopy~     protocol.~   "
559|NCT03049865|"~     The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a~     patient about to be discharged after a hospital stay for an acute illness, is related to the~     risk of readmission.~   "
18842|NCT02810756|"~     The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done~     in a patient cohort of n = 12.~   "
414|NCT03051763|"~     The aim of this study is to 1) descriptively report possible in flight events and 2) to~     provide regression analysis if the number of events are statistically significant in their~     prevalence and thus are useful in finding possible parameters in echocardiography, right~     heart catheterization, laboratory findings, spiroergometry as well as six minute walk test~     to produce a risk assessment for possible expected in flight adverse events as well as a~     recommendation concerning the need of supplemental oxygen for each individual patient.~      The investigators therefore want to find out:~        1. In which subgroup (if applicable) of PH patients in flight adverse events are more~          frequent.~        2. Whether there are parameters (from blood samples, blood gas analysis, World Health~          Organization-Functional Class (WHO-FC), Six Minute Walk (SMW), echocardiography, right~          heart catheter (RHC)) that are able to predict in flight need for additional oxygen~          and/or possible adverse events.~   "
415|NCT03051750|"~     This crossover study compares two different treatment techniques for Breast Cancer-Related~     Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.~      2. Kinesio Taping.~   "
416|NCT03051737|"~     The main objective of this retrospective study is to validate a prediction system of~     emergencies department (ED) attendance on a wide range of time and the need for~     hospitalization, at various levels of perimeter (with all emergency departments or one ED in~     particular), with all patients or with one sub-group of patients (age, gravity, care).~   "
417|NCT03051724|"~     Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure~     (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is~     complex. New communication technologies and the current health challenges, such as aging and~     high health care costs have encouraged the interest in new strategies.~      As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that~     use internet and mobile technologies usually. However, there is a significant percentage of~     patients that does not use Internet and mobile technologies, only the 58% of patients over~     65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is~     conflicting, it suggest that it's applicability depends in patient's characteristics and it~     is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med~     2012). That's why the investigators believe that the next step should be to choose those~     patient's that doesn't use Internet or mobile technologies and to verify the applicability~     of a telematic system that could facilitate the extra hospital management of this patient's.~      The aim of the study is to evaluate the telematic management of various outcomes that are~     emitted by CPAP machine, and by an app where the patient's will answer different questions~     regarding their treatment during the three months of study period.~   "
418|NCT03051711|"~     To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic~     conditions, at Day 15 compared to Baseline.~   "
419|NCT03051698|"~     The purpose of this proof-of-concept study is to determine the effect of Intestinal~     Microbiota Depletion or Intravenous Administration of C1-inhibitor on Inflammation and~     Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide~     in Allergic Asthma Patients~   "
420|NCT03051685|"~     Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to~     determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions~   "
421|NCT03051672|"~     This research study is studying radiation therapy in combination with an immunotherapy as a~     possible treatment for metastatic hormone receptor (HR) positive, HER2-negative breast~     cancer.~      The interventions involved in this study are:~        -  Palliative Radiotherapy~        -  Pembrolizumab~   "
422|NCT03051659|"~     This research study is exploring chemotherapy in combination with immunotherapy (a therapy~     that uses the body's own immune system to control cancer) as a possible treatment for~     metastatic hormone receptor positive breast cancer.~   "
423|NCT03051646|"~     Exercise has many benefits for people with multiple sclerosis (MS), such as improved~     physical symptoms, mood, fatigue, and cognition. However, many people with MS refrain from~     exercising because of the discomfort of exhaustion and overheating that they experience.~     This study investigates the use of aspirin before exercise as a treatment to reduce~     overheating and exhaustion, thereby availing many more people with MS the opportunity to~     benefit from exercise.~      The investigators recently published the first-ever report of elevated body temperature in~     relapsing-remitting MS (RRMS) patients relative to healthy controls, and elevated~     temperature was linked to worse fatigue. This finding that body temperature is elevated and~     linked to fatigue in RRMS lays the groundwork for a paradigm shift in our understanding and~     treatment of fatigue. That is, the focus shifts from exogenous to endogenous temperature,~     and from stimulant medication to cooling treatments.~      A recent study comparing healthy adults to adults with MS showed that whereas exercise~     increased body temperature in both groups, only in the MS group was it correlated with~     exhaustion. The reason for this may relate to the elevation in resting body temperature in~     relapsing-remitting MS (RRMS) patients relative to healthy controls. The finding is~     clinically meaningful, as elevated body temperature was correlated with worse fatigue in~     patients. Exercise Aim: To determine whether pretreatment with ASA (compared to placebo:~     within subject crossover design) before exercise results in improved exercise performance~     (i.e., increased time-to-exhaustion). The investigators hypothesize that participants will~     tolerate exercise for longer after taking ASA than placebo. This hypothesis is based on a)~     demonstrated efficacy of antipyretic for reducing body temperature during exercise in~     healthy controls, b) demonstrated efficacy of antipyretic for reducing fatigue in~     non-exercising MS patients, and c) demonstrated efficacy of elaborate (unblinded) cooling~     treatments (e.g., cooling garments, cooling hand chamber) for improving exercise performance~     in MS patients. Note that this project is especially important for MS patients, who have a~     disease-specific body temperature elevation and sensitivity to heat (i.e., Uhthoff's).~   "
424|NCT03051633|"~     The goal of this project is to test the effectiveness of a successful anti-drug~     communications campaign (Be Under your Own Influence) to lower substance use among AI 7th~     graders. The campaign uses messages that support youths' personal autonomy and future~     aspirations, and these messages are delivered to 7th graders using high school students. Our~     goal is to develop a turnkey package for the broader population of AI youth and schools and~     to develop components that can incorporate flexibility and creativity in their delivery.~   "
425|NCT03051620|"~     The study is a cohort study comprising 140 patients with osteoporosis stopping treatment~     with alendronate. The study will contribute with new knowledge about biochemical markers of~     bone turnover as predictors of bone loss after stopping treatment with alendronate.~   "
426|NCT03051607|"~     Phase 3, international, multicenter, open-label 12 month safety study.~   "
460|NCT03051165|"~     This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different~     measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People~     with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study~     site will be told about the study at their 2-week post-operative appointment. Those who~     decide to participate will have blood drawn and vascular function measurements taken before~     HGNS activation, during treatment, and after a temporary treatment withdrawal period.~     Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.~   "
427|NCT03051594|"~     1. Three dentinal carious lesions will be chosen in this study and will be in the same~          patient.~        2. Using local anaesthesia and rubber dam, the operative field will disinfected with 1%~          hypochlorite, and the dentine lesions should be exposed with a high-speed diamond bur~          by removing covering enamel.~        3. Before the excavation dentine samples are collected for baseline bacteriological~          assessment .~        4. Excavation will be carried out using new slow speed round burs and hand excavators.~        5. The excavation end point of one cavity will be determined using visual tactile method.~          The two other cavities will be inspected with fluorescent camera or caries detector dye~          (CDD) methods to determine excavation endpoint respectively.~        6. After excavation, dentine samples from the three cavities will be collected using a~          sterile excavator for the bacteriological assessment.~             -  Number of visits & follow up period: all procedures will be done at the same visit~               and there is no follow up period.~      Direct benefit of the research to the human volunteer: to determine the excavation endpoint~     to ensure complete caries removal and prevent it's recurrence in the future.~      Scientific value and social benefits: to reach the best method to determine the excavation~     endpoint.~      Expected risk to the human subjects: the ordinary side effects associated with any~     restorative treatment and no of the study variable has side effect on the patient and in~     case of any side effect due to the restorative treatment, the participant will directly~     contact the operator.~   "
428|NCT03051581|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     PTCL can predict disease progression~   "
429|NCT03051568|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using~     the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease~     progression during chemotherapy or survival in PTCL.~   "
430|NCT03051555|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     NK/T-cell lymphoma can predict disease progression~   "
431|NCT03051542|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using~     the liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease~     progression during chemotherapy or survival in NK/T-cell lymphoma.~   "
432|NCT03051529|"~     This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent~     non cardiac surgery in the lower half of the body under the effect of combined spinal~     epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring~     including invasive blood pressure, heart rate, and CVP was established, in addition to pre~     and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic~     peptide measurement were done .~      This study tried to assess the safety of this anesthetic technique on such group of cardiac~     patients along over the hospital stay period and up to 6 months postoperatively, in addition~     to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the~     major adverse cardiac events and cardiac mortality for these group of patients .~   "
433|NCT03051516|"~     This randomized phase IV trial studies how well human papillomavirus (HPV) vaccine therapy~     works in interrupting progression in patients with high-grade vulvar or anal lesions.~     Vaccines made from HPV peptides or antigens may help the body build an effective immune~     response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress~     or come back.~   "
434|NCT03051503|"~     to determine the safety, efficacy and tolerability of transdermal fentanyl in patients~     undergoing mastectomy, as well as the postoperative consumption of analgesic.~   "
435|NCT03051490|"~     Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived~     lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to~     evaluate the non-inferiority of liprotamase compared with porcine-derived,~     enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy~     endpoint of the study will be comparative efficacy measured as the change from baseline in~     the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic~     insufficiency (EPI).~   "
436|NCT03051477|"~     This study will seek to determine the safety and toxicity profile as well as the maximum~     tolerated dose of Helixor® M in patients with advanced solid tumors.~   "
437|NCT03051464|"~     A pilot study of 40 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be~     randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or~     Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard~     chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a~     brachytherapy boost of 30 Gy in 3 fractions).~   "
438|NCT03051451|"~     Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel~     groups, randomized treatment to assess the efficacy and safety using a fixed dose~     combination of metformin hydrochloride with fluoxetine as adjunctive treatment in patient~     with obesity or overweight in order to generate new knowledge and give a greater number of~     therapeutic options to the clinicians, one group will receive metformin 1700 mg and 40 mg of~     fluoxetine; Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a~     third group called control will receive placebo.~      The above described treatments will be administered according to the Dosage Schedule The~     three groups will receive tablets of physical characteristics equal to the reference drug to~     preserve the blinding.~   "
439|NCT03051438|"~     Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising~     and exciting approach for minimally invasive thoracic surgery. However, nearly all reported~     uniportal VATS lobectomies have been performed via the intercostal route, and chest wall~     trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique~     involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and~     advantages.~   "
440|NCT03051425|"~     To investigate the impact of consuming dairy yogurt on immun function including natural~     killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in~     elderly.~   "
475|NCT03050970|"~     The purpose of this study is to validate a clinical decision rule for the management of~     minor head trauma in infants aged less than two years, constructed with the intention of~     minimizing the rate of computed tomography scans ordering.~   "
633|NCT03048890|"~     VascTrac is a mobile medical application that tracks users' physical activity levels in~     order to predict endovascular failure of patients with Peripheral Artery Disease.~   "
441|NCT03051412|"~     Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females,~     which is associated with decreased quality of life and physical activity levels. PFP is~     highly persistent, with up to 50% of adolescents reporting persistent pain at both one and~     two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older~     individuals with chronic pain, however, less is known about this in conditions such as PFP,~     which is common in younger populations. Additionally it is unknown if these characteristics~     return to similar values as healthy controls, when symptoms resolve.~      The aim of this study will be to compare pain sensitivity in individuals with PFP, compared~     to those with a previous history of PFP who currently are pain-free, and a control group~     with no history of knee pain.~   "
442|NCT03051399|"~     Previous in vitro studies suggest that EpiCor is well fermented in the colon and has~     prebiotic potential. The repeated long-term administration of low doses of EpiCor in the~     Simulator of the Human Intestinal Microbial Ecosystem (SHIME) has shown that this product is~     able to induce gradual changes in the colonic environment by: i) being selectively~     fermented, leading to butyrate increase in the colon; ii) stimulating Lactobacilli growth in~     the lumen and adherence to the mucosal surface, and iii) decreasing potential pathogens. In~     addition, the fermentation-derived metabolites produced in the colon were shown to~     potentially benefit the host by decreasing cytokine levels in vitro. As a result, the~     investigators hypothesize that EpiCor may help to improve bowel function and generally~     contribute to enhanced gut health. Therefore, this pilot study is intended to assess the~     effects of long-term administration of EpiCor on a population with mild symptoms of~     intestinal dysfunction.~      The primary objective of this exploratory pilot study is to assess the effect of long term~     administration of EpiCor on bowel function and gastrointestinal well-being, by means of~     validated questionnaires.~      This study has 4 secondary objectives: 1) The first secondary objective of this study is to~     assess the protective effects of EpiCor on intestinal barrier function, by performing a gut~     sugar permeability test in combination with indomethacin challenge; 2) The second secondary~     objective is to assess the effects of EpiCor on intestinal barrier function, by measuring~     blood Zonulin and endotoxin levels in combination with indomethacin challenge; 3) The third~     secondary objective of this study is to assess the prebiotic properties of EpiCor by~     collecting fecal samples. The microbial community composition, lactate and SCFA profiles and~     proteolytic activity markers in feces will be determined. Proteolytic activity markers will~     also be measured in urine samples; 4) The fourth secondary objective of this study is to~     assess the effects of EpiCor on local and systemic immune system performance by measuring~     secretory IgA levels in feces and cytokines in blood.~   "
443|NCT03051386|"~     The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live,~     Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of~     occupational VEE virus infection in vaccinated personnel.~   "
444|NCT03051373|"~     Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients~     with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even~     if clinical benefits and survival remains limited.~      The purpose of this study is to test in a randomized trial enrolling patients for comparing~     the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order~     to determine the most promising agents as the first line treatment of advanced and/or~     metastatic transitional cell carcinoma of urothelial tract.~   "
445|NCT03051360|"~     Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower~     lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis,~     through a randomized controlled trial.~   "
446|NCT03051347|"~     This is designated to validate patient-reported outcomes (PRO) measures in itch-specific~     pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified~     stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis~     and other potentially stigmatizing conditions.~   "
447|NCT03051334|"~     This study sought to evaluate changes in ascending aorta size after transcatheter aortic~     valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with~     patients with tricuspid aortic valve (TAV).~   "
448|NCT03051321|"~     The inability to independently manage perineal hygiene after toileting is a common issue for~     those in assisted living and nursing home environments. It is associated with skin breakdown~     (dermatitis), increased nursing costs, and loss of patient self-esteem and independence.~     Water-based toileting has been evaluated as a possible adjunct to patient care, but its~     uptake has been limited by ineffective cleansing and drying.~      40 subjects with limitations in independent capacity for perineal hygiene that require~     assistance with toileting will be recruited from a continued care retirement center.~     Subjects will be assessed for incontinence, and skin breakdown or irritation. Subjects will~     be provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to~     be applied in cases of dermatitis.~      Investigators hypothesize that subjects given the device will remain more independent, with~     higher quality of life. Secondary hypotheses are that subjects will experience improved~     relationships with their caregivers, and that active dermatitis will be treated in those~     already with the condition, and prevented in those at risk.~   "
449|NCT03051308|"~     Compare the functionality of new parathyroid transport solution (NPTS) with University of~     Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability,~     parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR)~     levels during cold ischemia.~   "
450|NCT03051295|"~     There is little evidence on how best to present diagnostic and treatment effect information~     to dentists and whether this makes any difference to their understanding of the information~     given and clinical management. The objective of this study is to assess the influence of~     different formats for presenting diagnostic test results and treatment efficacy on dentists'~     understanding and on their reported clinical management. The hypothesis is that presenting~     diagnostic test and treatment effectiveness results using natural frequencies influences the~     threshold for treatment and improves interpretation of tests results compared to conditional~     probabilities and percentage differences. A group of dentists recruited from postgraduate~     courses were randomized to two of four arms, being two arms of a hypothetical realistic~     diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1)~     diagnostic test results presented in conditional probabilities; a2) diagnostic test results~     presented in natural frequencies; b1) treatment efficacy presented in percentages; b2)~     treatment efficacy presented in natural frequencies. The main outcome measures were the~     correct answer as to whether disease was actually present (post-test probability) and the~     correct answer as the number of patients that would benefit from the treatment (efficacy).~     Secondary outcome measures included the decision whether to treat or not treat the~     hypothetical patient.~   "
493|NCT03050736|"~     The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the~     maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation~     regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the~     methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be~     explored and tumor responses to treatment will be evaluated.~   "
451|NCT03051282|"~     Angiotensin-converting enzyme inhibitors (ACEIs) are among the most frequently prescribed~     medications worldwide for the treatment of essential hypertension, left ventricular systolic~     dysfunction, acute myocardial infarction, and prevention of the progression of diabetic~     nephropathy. However, the outcome of ACEI treatment varies significantly between individuals~     and selected populations. Suboptimal response, therapeutic failure, and significant side~     effects are commonly documented in patients receiving ACEI therapy. Approximately 80% of the~     ACEIs available for use in the US are synthesized as esterified prodrugs in order to improve~     otherwise poor oral bioavailability of the active molecule. The activation of ACEI prodrugs~     primarily occurs in the liver via metabolic de-esterification of the parent drug. The~     critical activation step is essential in delivering a successful therapeutic outcome since~     the active metabolites are approximately 10-1000 times more potent relative to their~     respective parent compounds. Carboxylesterase 1 (CES1), the most abundant hydrolase in the~     liver, is responsible for the activation of ACEI prodrugs in humans. Marked interindividual~     variability in CES1 expression and activity has been documented, which results in varied~     therapeutic efficacy and tolerability of many drugs serving as substrates of CES1. Genetic~     variation of CES1 is considered to be a major factor contributing to variability in CES1~     function. The study team proposes to conduct a multiple-dose healthy volunteer study to~     evaluate the impact of CES1 genetic variation on the activation, pharmacokinetics, and~     pharmacodynamics of enalapril, a model ACEI prodrug activated by CES1. The completion of~     this study will represent a major step towards the establishment of an evidence base from~     which a more individualized use of ACEI prodrugs can emerge.~   "
452|NCT03051269|"~     In a phase I protocol to primarily investigate the safety of using calcium combined with~     electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on~     PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation,~     biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to~     electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC~     QLQ C-30 and H&N35 (european organisation for research and treatment of cancer).~   "
453|NCT03051256|"~     This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to~     assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as~     adjunctive therapy in the treatment of patients diagnosed with major depressive disorder~     (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have~     experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant~     medication. This population will provide the opportunity to compare the safety and efficacy~     effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the~     effects of an antidepressant alone. This study includes in-patient and out-patient periods.~   "
454|NCT03051243|"~     Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85~     years old with known with history of DM for more than 3 months and an average of two~     consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral~     antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1~     ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with~     basal insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine~     once daily and glulisine (Apidra; sanifi) before meals.~      Patient will be discharged according to discharged protocol. Follow-up visits will take~     place at 3 and 6 months post discharged.~   "
455|NCT03051230|"~     Introduction: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic phenomenon, poorly~     understood and difficult to predict, complicating intense ovarian stimulation cycle. The~     most severe symptoms, which associate vascular permeability disorders and~     hypercoagulability, occur in 0.2 to 1% of the cases and often require intensive care.~      Activation of endothelial, platelet, erythrocyte or leukocyte cells trigger the release of~     small specific vesicles, called microparticles, used as markers.~      Classically leading to endothelial dysfunction and hypercoagulability, the endothelial~     activation phenomenon could constitute the main cause of OHSS or help predict its severity,~     as established for various other diseases (cerebral stroke, infarct and lupus…). However, so~     far, this endothelial activation role has never been studied.~      Objectives:~      Evaluate the serum level of microparticles as a predictor of adverse outcomes; correlate it~     to hypercoagulability and changes of endothelial permeability associated with this syndrome.~      Methodology: Prospective Pilote Cohort study, evaluating before and throughout the ovarian~     stimulation cycle (6 samples/patient), the serum modulation of:~        -  Endothelial activation markers (endothelial-derived microparticles, E-selectin)~        -  Procoagulant markers (microparticles from platelet, erythrocyte or leukocyte origin,~          Von Willbrand factor, thrombin-antithrombin complex, prothrombin fragment 1+2)~        -  Endothelial disjunction marker (soluble CD 146) A group of 50 patients will be assessed~          Techniques: Flow cytometry for measurement of microparticles expressing non specific~          (Annexin V) and cell specific surface determinants (CD 31, CD 41, CD 45 or glycophorin~          A). Use of commercial kits for other serum markers.~   "
456|NCT03051217|"~     The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol~     (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese~     subjects.~   "
457|NCT03051204|"~     Study Aims:~      To analyze stool specimens to test and validate the CalproLab assay against the predicate~     PhiCal in order to determine performance characteristics.~      And to correlate Calpro levels to the gut microbiome composition.~   "
458|NCT03051191|"~     Subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared to~     general population. We hypothesized that shared molecular mechanism play a pivotal role in~     the pathogenesis of CVD including heart failure (HF) and cancers. To address this~     hypothesis, we are going to explore the expression pattern of micro RNA (miRNA) and cell~     free DNA (cfDNA) derived from host, gut microbiota and gut microbiota composition~     extensively in patients with or without CVD, non-ischemic HF (NIHF), and cancers. These~     patients will be recruited from the outpatient clinic in Sakakibara Heart Institute or~     Japanese Foundation for Cancer Research. By comparing the expression pattern of miRNA,~     cfDNA, or gut microbiota composition, we are seeking to find the pathogenic mechanisms~     shared by those diseases.~   "
459|NCT03051178|"~     The purpose of this study is evaluate the effectiveness and safety of a possible new~     treatment for Essential Tremor (ET) using external wearable sensors, which have the~     capability of recording acceleration and Electromyography (EMG). This therapy is called~     Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer,~     and apply stimulation when the computer detects patterns associated with tremor. This~     detection will suppress pathological activity and improve or alleviate the tremor.~      Currently, DBS is approved for the treatment of ET; however, stimulation is delivered~     continuously even when tremor or other symptoms are absent. Continuous DBS can lead to~     unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS~     will turn on only if activity associated with ET from the external sensors is detected.~   "
461|NCT03051152|"~     Background: Literature often shows limited and discordant data regarding the prognostic~     value of age in gastric-cancer patients. Generally, disease-specific survival does not seem~     to be worse in the elderly when compared with younger patients, and therefore gastrectomy~     with extended lymphadenectomy for non-early tumors is considered the standard surgical~     therapy for all of operable patients, despite any age- or comorbidity-related limitations.~     Recent trials reported a survival benefit for extended nodal dissection compared with the~     more limited method, but some Authors found age (and comorbidities) to be a relevant~     predictor of postoperative complications, conditioning the safety of the surgical procedure~     itself.~      Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk~     Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All~     patients >75 years and with Charlson Comorbidity Score >5 with resectable M0 gastric cancer~     are eligible for inclusion and randomization. The primary endpoint is 5-year~     Disease-Specific Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS)~     and postoperative complications classified according to Clavien-Dindo. Assuming an alpha~     (two-sided) of 5%, 232 patients per group are necessary to achieve an 80% power to detect a~     13% survival difference (from 56% to 69%) between groups.~      Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal~     extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric~     cancer patients.~   "
462|NCT03051139|"~     The primary objective of this study is to evaluate whether a multi-component implementation~     strategy/quality improvement intervention comprised of 1) clinical decision support that~     couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS)~     recognition tool with a clinician alert system, and 2) audit and feedback improves the~     implementation of low tidal volume ventilation (LTVV) for patients with the acute~     respiratory distress syndrome (ARDS). This will be accomplished with a cluster randomized~     controlled trial comparing the implementation strategy to usual care~   "
463|NCT03051126|"~     To develop a tissue bank library for patients with parathyroid disease who have undergone~     surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer~     Center or outside centers, and/or all patients seen through the Parathyroid Center at~     participating sites, whether or not the patients undergo treatment for their disease. The~     tissue bank will contain both normal parathyroid tissue and diseased tissue, and will~     provide a resource for the ongoing study of parathyroid disease and management.~   "
464|NCT03051113|"~     Neuromas are frequent after trauma and surgery, including amputation and can be identified~     by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is~     uncertain. In this observational cohort study, the investigators wish to explore if the~     prevalence of neuromas are higher in patients with pain after peripheral nerve injury and~     amputation, than in patients with the same conditions but without pain.~   "
465|NCT03051100|"~     The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002)~     180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in~     patients with elevated LDL cholesterol.~   "
466|NCT03051087|"~     to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in~     infertility women for assisted reproductive technologies~   "
467|NCT03051074|"~     The studies proposed in this protocol aim to explore the anxiolytic properties of floating~     as it relates to the central and autonomic nervous system.~   "
468|NCT03051061|"~     The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with~     Atrial Fibrillation (AF) is the hotspot at present. Although the European and American~     guidelines have given a hand for us, however,there is absence of solid evidence-based data~     on the safety of antithrombotic therapy in Asian populations. A vailable clinical trials and~     registries provide remarkably little evidence to guide difficult clinical decision making in~     patients with combined AF and CHD，we highlight the lack of sound evidence to guide clinical~     decision making and the need for the rapid development of clinical trials to close the large~     gaps in evidence.~      Our research aims to know the real-world use of antithrombotic treatment and clinical~     prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.~   "
469|NCT03051048|"~     Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom~     treatment was delayed. However, repercussion time was limited in previous studies. To~     evaluate the system delay and clinical outcomes among China patients with AMI,12,000~     consecutive inpatient case prospectively collected from 2004 to 2016. Basic data and~     innovative evidence will accelerate evidence-based clinical practice and policy making, and~     improve AMI patients outcomes finally.~   "
470|NCT03051035|"~     This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated~     dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed~     and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a~     recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific~     extension cohorts may be conducted to further characterize the safety and tolerability of~     KO-947 and provide preliminary evidence of anti-tumor activity.~   "
471|NCT03051022|"~     The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an~     adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower~     extremities.~   "
472|NCT03051009|"~     Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of~     subjects with nocturia due to nocturnal polyuria, for up to 1 year~   "
473|NCT03050996|"~     Urinary continence recovery remains one of the most bothersome side effect of modern radical~     prostate surgery and several technical modifications, especially in Robotic assisted radical~     prostatectomy procedures, have been reported in order to improve early urinary continence~     recovery.~      With the aim to improve the urinary continence recovery after robotic prostatectomy, we~     evaluate the impact of the use of a 6-branch retropubic suburethral autologous sling,~     created and placed during the procedure, in association with intraoperative evaluation of~     the retrograde leak point pressure by means of retrograde perfusion sphincterometry for~     proper sling tensioning.~   "
474|NCT03050983|"~     Single site prospective observational nested study of bedside CS20p monitor on the GCF~     impeded into a retrospective review of the frequency of escalation of care with intermittent~     vitals signs compared to continuous respiratory monitoring.~   "
476|NCT03050957|"~     Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (>70~     years) and has been recently recognized as a geriatric syndrome. The main features of OD~     are: a high prevalence and severe complications either related with the decreased swallowing~     efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50%~     prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50%~     of mortality rate. However, there is no specific pharmacologic treatment for OD in older~     patients yet. Treatments are now evolving from compensation to active treatments aiming to~     restore the swallowing dysfunction and some groups have been looking for new therapeutic~     strategies. The main goal of this study is to evaluate the effect of administering menthol~     in bolus on the swallowing response in elderly and neurogenic patients with OD. In addition,~     this study will also assess the side effects of this pharmacological strategy.~   "
477|NCT03050944|"~     Infertility affects one of every six couples and one out of ten couples may seek fertility~     treatment such as ovulation induction and assisted reproductive technologies. With respect~     to diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups,~     have been associated with the risk of subfertility; however, more information is needed on~     the role of dietary factors in reproductive functions. However, evidence concerning the~     association between dietary patterns, such as the Mediterranean diet (MD) pattern, and~     fertility is scarce. The aim of this study is to investigate the relationship between~     preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF)~     outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular~     fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and~     follistatin concentrations will be measured on each day of the ovarian stimulation protocol.~     Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation,~     clinical pregnancy and live birth rates.~   "
478|NCT03050931|"~     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can~     produce reproducible and accurate images in people with epilepsy compared to existing~     standards such as MRI, CT or EEG.~      Electrical Impedance Tomography is a relatively new medical imaging method, which has the~     potential to provide novel images of brain function. It is fast, portable, safe and~     inexpensive, but currently has a relatively poor spatial resolution. It produces images of~     the internal electrical impedance of a subject with epilepsy using rings of ECG like~     electrodes on the skin, intracranial electrode mats or deep electrodes implemented~     surgically as part of clinical assessment. EIT recording will take place in parallel with~     the routine recording on the ward. Following completion of the recording, the EIT images~     will subsequently be analysed and compared to other imaging data for accuracy.~   "
479|NCT03050918|"~     The goal of this project is to quantify the impact of post-hospital discharge follow-up~     phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a~     general medicine inpatient population. We will obtain exploratory information on patient~     sub-groups at high risk for hospital readmission and on those experiencing high benefit from~     the follow-up phone call intervention. In addition, we will obtain data on discharge plan~     implementation assistance needed to support a successful transition from inpatient to~     outpatient care among those reached by the intervention phone call.~   "
480|NCT03050905|"~     HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular~     carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype~     displays a different geographic distribution.~      Since different HCV genotypes react differently on available antiviral therapies, the~     correct identification of HCV genotype serves as a marker of responsiveness and an indicator~     for duration of treatment.~      The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.~      A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical~     laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This~     assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these~     findings, the number of patients with 2k/1b may be underestimated.~      AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3~     DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV~     proteins essential for viral replication. The high efficacy of the 3D regimen was proven in~     registration clinical trials and RW for 1b population.~      3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective~      • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an~     interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.~      Study Design:~      .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to~     label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects~     will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for~     antiviral response, clinical outcomes, patient reported adverse events and presence and~     emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of~     treatment and extra 24 weeks of follow up. Scheduled visits will include: physician~     assessment and blood tests including HCV resistance mutations.~   "
481|NCT03050892|"~     Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day~     recipient mortality in order to improve graft screening.~   "
482|NCT03050879|"~     The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer~     using in laparoscopic gastrectomy with lymph node dissection for gastric~     adenocarcinoma（cT1-4a, N-/+, M0）.~   "
483|NCT03050866|"~     After failure on docetaxel, which has been the standard first line therapy for patients with~     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are~     currently available.~      In retrospective studies, resistance has been described to two of the treatment options,~     enzalutamide and abiraterone, when a splice variant of the Androgen Receptor (AR-V7) is~     present on circulating tumor cells (CTCs). The investigators hypothesize that patients with~     AR-V7 positive CTCs do have a meaningful response to cabazitaxel.~   "
484|NCT03050853|"~     This study will evaluate behavioral and psychological appeal, toxicity, and effect of~     e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious~     mental illness (SMI) who have failed to quit smoking. We will enroll 240 participants and~     randomly assign them to either receive a supply of e-cigarettes for 8 weeks plus assessments~     (baseline & weeks 2, 4, 6, 8, 13, & 26) or assessments only. This single-blinded study will~     provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred~     from carefully assessed use of e-cigarettes and reduction in combustible tobacco. We will~     also collect qualitative data from participants assigned to e-cigarettes, given that~     unanticipated issues will almost certainly arise in connection with their use that can only~     be captured within a qualitative debriefing at the conclusion of participants' time in the~     study.~   "
655|NCT03048604|"~     The study is designed as a prospective, open-label, multicentre, non-randomized, single arm~     treatment study to assess the safety, performance and initial efficacy trends of the GenioTM~     System in patients with Obstructive Sleep Apnoea (OSA).~   "
485|NCT03050840|"~     Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the~     United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile~     or ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and~     physical activity, but change in these behaviors requires self-monitoring and support, and~     weight loss is not always successful.~      Parent involvement and parent weight-loss can help their children to lose weight and~     successfully change their behavior. Guidance from pediatricians can also help to facilitate~     weight loss among obese adolescents. That said, treatment of obesity through behavior change~     within the time constraints of a Pediatric practice visit is limited by treatment adherence~     and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep~     adolescents with severe obesity engaged in therapy outside of standard practice is a~     critical need.~      The effects of monetary incentives through games (gamification), and a comprehensive remote~     digital monitoring system on sleep, physical activity, and dietary intake, has been~     successful in adults, but has not been tested in adolescents with obesity.~   "
486|NCT03050827|"~     Investigators propose a placebo controlled, double blinded study to examine efficacy of~     topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type~     2 diabetic subjects with established peripheral neuropathy. This site most clearly~     demonstrated efficacy of topiramate in reversing IENF loss within 18 weeks in our prior~     study. Subjects will also undergo quantitative sensory testing (QST) and assays of laser~     Doppler skin blood flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life~     (Norfolk QOL-DN), along with standard measures of physiology and fasting blood chemistry.~     Subjects with IENF loss of between 20-75% of normative values and thus amenable to~     therapy-induced recovery, will be randomized into placebo (N=30) or active drug (N=30) arms~     and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2~     region of skin adjacent to the initial biopsy site, as per the manufacturers instructions~     (http://www.gelnique.com/gel3/). Treatment will continue daily for 20 weeks, with monthly~     phone calls to monitor compliance. After 20 weeks, subjects will return for a second series~     of measurements and 3 mm skin biopsy from the treated region of skin.~   "
487|NCT03050814|"~     Background:~      Colorectal cancer is a common cancer in the U.S. It causes the second most cancer-related~     deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer.~      Objective:~      To test if avelumab and Ad-CEA plus standard therapy treats colorectal cancer that has~     spread to other sites better than standard therapy alone.~      Eligibility:~      People ages 18 and older with untreated colorectal cancer that has spread in the body~      Design:~      Participants will be screened with:~      Test to see if their cancer has a certain deficiency~      Blood, urine, and heart tests~      Scans~      Medical history~      Physical exam~      Tumor sample. This can be from a previous procedure.~      A small group of participants will get Ad-CEA and avelumab plus standard therapy. This is~     FOLFOX plus bevacizumab for up to 24 weeks then capecitabine plus bevacizumab.~      The others will have treatment in 2-week cycles. They will be Arm A or B:~      Arm A: FOLFOX and bevacizumab by IV days 1 and 2 for 12 cycles. After that, capecitabine by~     mouth twice a day and bevacizumab by IV on day 1.~      Arm B: Ad-CEA injection every 2 12 weeks. Avelumab by IV on day 1 of each cycle. FOLFOX and~     bevacizumab by IV days 2 and 3 for 12 cycles. Then, capecitabine by mouth twice a day and~     bevacizumab through IV on day 2.~      Participants will repeat screening tests during the study.~      Participants will be treated until their disease gets worse or they have bad side effects.~     Arm A participants can join Arm B. They will have a visit 4 5 weeks after they stop therapy.~   "
488|NCT03050801|"~     Background:~      Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to~     problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help~     improve connections between brain areas in healthy people. Researchers want to see if it can~     be useful in patients with memory problems after TBI.~      Objective:~      To see how repetitive transcranial magnetic stimulation can be used to improve the~     connections between parts of the brain and whether this will lead to changes in memory.~      Eligibility:~      Adults 18 50 years old with TBI who can speak and write in English.~      Healthy volunteers the same age and English ability.~      Design:~      Participants will be screened with a neurological exam and may have a urine pregnancy test.~      Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8.~      At the visits, participants will have all or some of the following:~      MRI for about 1 hour. They will lie in a machine that takes pictures in a magnetic field.~     They will do some memory tasks.~      Memory and attention tasks with pictures and with a computer~      Questions about their mental state and well-being~      TMS: A wire coil is held on the scalp and a short electrical current passes through it.~     Participants will hear a click and feel a pulling or twitch. They may be asked to make~     simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this for~     about 20 minutes.~      A week after the last visit, some participants will return for a memory test.~   "
489|NCT03050788|"~     The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS)~     that may be eventually deployed with portable, point-of-care techniques. This approach~     features confocal microscopy. The investigators will compare this new approach with the gold~     standard of histology from a traditional skin punch biopsy (which is standard of care) to~     determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.~   "
490|NCT03050775|"~     The purpose of this study is to evaluate patients' temperatures after using one of two~     ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™~     system) or the standard ventilator circuit with a heat-moisture exchanger (standard~     ventilator). The ANAPOD™ system will provide additional heat and humidity to patients~     through their breathing tube while the standard ventilator will not. The investigators are~     doing this research study to find out if the ventilator circuit providing additional heat~     and humidity will keep patients warmer during surgery and after surgery.~   "
491|NCT03050762|"~     The goal of this data review study is to collect data to learn more about thyroid,~     parathyroid, and adrenal disease.~   "
492|NCT03050749|"~     In this study, eligible patients with the medical indications (facial lipoatrophy,~     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®~     VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the~     treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed~     appropriate by the Investigator.~   "
496|NCT03050684|"~     Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in~     term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and~     associated with this, vaginal infections rates increase. With the vaginal application of~     Propess, the preparate remains in the vagina for a long time, with controlled~     release,creating a film layer against bacteria and especially fungal infections and it was~     thought that this could be a reason for unsuccessful birth induction by preventing release~     of this ovule.~      The aim of this study is to observe whether or not the rate of caesareans with the~     indication of unsuccessful induction was reduced in patients by reducing the density of~     vaginal bacteria and fungi with vaginal lavage and thereby increasing the effect of the drug~     and decreasing the rate of unsuccessful inductions.~   "
497|NCT03050671|"~     This study aims to compare two different external calf compression devices applied in~     healthy individuals. These devices are commonly used in medical care in order to prevent the~     formation of blood clots, for example during immobilization after surgery. We aim to comfirm~     the effects of external cyclic compression on healing and blood clotting and also to~     identify the one which is more effective.~   "
498|NCT03050658|"~     Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and~     increasing prevalence in Westernized countries. Current well newborn guidelines for washing~     babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence~     of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL)~     in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy~     development by age 2 years. Risk for AD in babies was also linked to decreased skin~     colonization with certain skin microflora, such as staphylococcal organisms. Together, these~     data raise the question of whether newborn skincare guidelines have the potential to modify~     a baby's risk for allergy development. Our current practice of washing babies with soap may~     alter TEWL or other natural factors in skin that protect babies from development of AD and~     allergy. More knowledge is needed about the impact of infant skincare practices on allergy~     development.~      The objective of this pilot study is to determine the impact of a baby's first bath on~     his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include~     collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first~     bath in healthy term newborns at UVA. This data will serve as preliminary data for future~     studies.~   "
499|NCT03050645|"~     Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several~     metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of~     later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by~     the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of~     HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.~      In this study, women with previous GDM and a control group matched on age, time of birth and~     BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post~     partum examination (GDM only) will be used to identify risk factors for later development of~     DM. Further, life-style factors and mental health according to diabetes status will be~     studied.~   "
500|NCT03050632|"~     The investigators are interested about the degree to which individuals can persist with~     individualized treatment goals when their cues (external such as food, or internal such as~     anxiety) are high for impulsive/maladaptive behavior (e.g., purging, not eating, etc.). The~     investigators want to find specific high-difficulty situations in which to assess whether~     participants remain mindful of the big picture and are willing to work toward therapeutic~     goals. Also, the investigators want to rate the participants degree of success (e.g.,~     proportion of calories eaten) assessed more objectively.~      The theory is that working memory capacity (WMC) modulates the ability to keep longer-term~     goals in mind when faced by current stress/temptations. For example, the ability to control~     drinking when one has an implicit urge to drink is predicted by WMC. The ability to apply a~     novel emotional regulation skill at a time of stress is also predicted by WMC. Indeed, the~     generic ability to pursue goals in the future (as assessed by the discounting of the value~     of future goals) is reliably predicted by WMC. There is also evidence that activation of~     brain regions associated with WMC (by direct activation of the dorsolateral prefrontal~     cortex via transcranial magnetic stimulation (TMS), or by having a person complete a~     relevant cognitive task) improves delay discounting.~      Accordingly, the investigators are proposing a study that both assesses the link between WMC~     and relevant the clinical measures noted above, as well as changes in these measures~     following activation of WM with a cognitive prime (WM task). The overall design calls for an~     initial WMC assessment, followed by randomization to complete 3 days of a WM prime and then~     3 days of a no prime group, or vice versa. The investigators then assess the clinical~     outcomes noted above across the following 6 days, with a WM prime first or no prime first~     occurring prior to the targeted behaviors. The investigators will prime WM prior to~     participant's evening meal, with the WM intervention offered during the free time before~     this meal.~   "
501|NCT03050619|"~     Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the~     United Kingdom (UK) in August 2014. It can be expected that patients initiating~     empagliflozin may differ in their characteristics from patients initiating other glucose~     lowering drugs (GLDs) that have been on the market longer (e.g. patients may have poorer~     glucose control). Therefore, the proposed study aims to characterize patients with T2DM in~     the UK initiating empagliflozin in terms of baseline characteristics, concomitant~     medications, and comorbidities compared to patients with type 2 diabetes mellitus (T2DM)~     initiating other SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action,~     some patients taking empagliflozin have experienced weight loss in clinical trials. A~     theoretical possibility exists that empagliflozin may be used by patients without T2DM.~     Therefore, this study also aims to assess the potential off-label use of empagliflozin~     compared to other non-insulin GLDs.~   "
502|NCT03050606|"~     Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain,~     hyperalgesia and allodynia. Physical exercises are recommended as the first choice of~     non-pharmacological therapy. Thus, the purpose of this study is to evaluate the~     effectiveness and cost-effectiveness of modified Pilates method exercises compared to~     aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that~     Pilates exercises will be as effective as aerobic exercise in the improvement of clinical~     outcomes, and that this improvement will be maintained over the medium to long term. It is~     also expected that aerobic exercises will be more cost-effective.~   "
503|NCT03050593|"~     The investigators wish to test a hypothesis that patients with HFpEF have different~     characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to~     HFrEF and healthy volunteers.~   "
560|NCT03049852|"~     1. CBT-001 administered three times daily (TID) for 4 weeks has an acceptable safety~          profile when used in pterygium patients~        2. CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing~          pterygium vascularity and inhibiting pterygium lesion growth~        3. CBT-001 administered as topical ocular dosing displays negligible systemic drug~          exposure~   "
505|NCT03050567|"~     Hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques'~     is a common cause of strokes. Over time plaques can burst or may lead to a severe narrowing~     (stenosis) of the neck artery. When plaques burst, small clots or fatty particles (called~     microemboli) break off, block brain vessels and lead to a stroke. Researchers have an~     incomplete understanding of the processes that cause hardening of the arteries, development~     of small clots and are unable to predict who will have a stroke. At present, the only~     ultrasound scan that evaluates circulation in the head and detects these small clots is~     called the Transcranial Doppler ultrasound. The aim of the study is to test this simple~     ultrasound technique to see if it can detect signals that may correspond to these small~     clots or fatty particles. The other objective is to see how repeatable the ultrasound~     technique is. This may help to identify patients with hardened neck arteries who are at~     higher risk of a recurrent stroke. This could also potentially improve patients selection to~     a targeted surgical or future novel pharmacological therapy.~   "
506|NCT03050554|"~     The purpose of the study is to determine whether avelumab has an effect on cancer and body~     in combination with SBRT, a standard treatment for early stage non-small cell lung cancer~     (NSCLC).~      Avelumab is considered experimental because it is not approved by the United States (U.S.)~     Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called~     a monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize,~     target and bind to specific proteins on the cells that make up your tissues. Avelumab is~     designed to block the interaction between PD-1, a known immune checkpoint, and PD-L1. By~     blocking this interaction, the immune system may be stimulated, allowing it to more~     effectively recognize and attack the cancer.~      Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise~     targeting to deliver a high dose of radiation to the tumor over a short period of time. A~     positioning cushion such as Vac-lok will be used during radiation treatment that is custom~     made. This custom mold forms to the contours of your body to allow for proper positioning~     comfort and stability.~   "
507|NCT03050541|"~     The purpose of this study is to examine the effects of MDMA on encoding and retrieval of~     emotional and social memories in healthy young adults. The study will explore the effects on~     memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.~   "
508|NCT03050528|"~     The aim of this study is to evaluate the effectiveness of a combined Exercise and Acceptance~     and Commitment Therapy (ACT) programme, compared to a standalone supervised exercise~     intervention for patients with chronic pain. Chronic pain is a common problem, which can~     have a significant impact on quality of life. While there are many treatments available for~     chronic pain, research has shown that improvements are often modest and short-term.~      Exercise therapy is known to be helpful for many chronic conditions and is recommended in~     clinical guidelines for the management of chronic pain. Acceptance and Commitment Therapy~     (ACT) is a form of psychological therapy, which focuses on improvement of function, rather~     than symptom reduction. There is an emphasis on psychological flexibility, values and~     mindfulness. This approach may be well suited to chronic pain, where symptoms can be beyond~     a person's control, but there is a need for further research, particularly with regards to~     combining ACT with a physical intervention.~      This study will take place in a Dublin University hospital. Patients will be randomly~     allocated to a combined exercise and ACT treatment group or a standalone exercise group.~     Both groups will have weekly treatment for eight weeks and will be assessed before and after~     treatment, and again twelve weeks later. Questionnaires will be used to measure the effects~     of the treatment on the degree to which pain interferes with various aspects of daily life.~     Activity trackers will be worn to measure daily physical activity levels. A purposeful~     sample of participants from both groups will also be invited to participate in a qualitative~     study following treatment.~   "
509|NCT03050515|"~     Recurrent urinary tract infections are quickly becoming a public health obstacle in our~     aging population. Almost 50% of women have at least one urinary tract infection in their~     lifetime; following this first infection, there is a 25-35% chance that she will have~     another infection in the subsequent 3-6 months. With each documented infection, a patient~     receives anywhere from a three to seven day course of antibiotics for treatment. Repeated~     courses of antibiotics often lead to the development of multi-drug resistant infections that~     are difficult to treat with our arsenal of oral medications. It is theorized that most, if~     not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If~     there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will~     likely be difficult to ever adequately treat repeat urinary tract infections. This same~     theory led to the development and utilization of fecal microbiota transplantation in the~     treatment of refractory Clostridium difficile diarrhea. There are now several studies that~     have reported on the efficacy of fecal transplantation in the treatment of C.difficile~     infections as well as the correction of gut dysbiosis. Given this positive response in~     treatment of refractory infectious diarrhea, the investigators propose that the correction~     of gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore,~     the investigators propose this pilot study to determine the effectiveness of fecal~     transplantation in the treatment of refractory, recurrent urinary tract infections.~   "
510|NCT03050502|"~     Chest injuries are common in patients with polytrauma and are responsible for approximate~     25% of all trauma-related mortalities. Traumatic injuries to the thorax often result in the~     accumulation of blood within the chest (i.e. a hemothorax (HTX)). The management of HTX~     remains a clinical dilemma when the volume of blood is small to moderate and the patient is~     hemodynamically stable. The East American Association of Trauma guidelines suggest that all~     HTXs should be considered for chest tube drainage. However, a prospective observational~     study suggested small to moderate HTXs could be absorbed without intervention. Although HTXs~     are effectively managed with chest tube drainage of the blood (i.e. tube thoracostomy), this~     intervention is associated with numerous potential major complications, including injury and~     infection in up to 22% of patients. The purpose of this study is therefore to conduct a~     randomized controlled study to compare patients with traumatic HTX managed by chest tube~     drain or expectant management (close monitoring), to determine when a chest tube is needed~     and when it is not to treat hemothoraces. The results from this study will inform the care~     of future trauma patients who present with this common injury throughout the globe.~   "
511|NCT03050489|"~     Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.~   "
514|NCT03050450|"~     Independently, both lenalidomide and vorinostat have shown promising activity in pediatric~     central nervous system tumors. These are both agents that are not typically part of~     first-line studies, although both agents are of serious interest and are currently in~     clinical trials for further investigation. This study is to evaluate the combination of~     lenalidomide and vorinostat in high grade or progressive central nervous system tumors in~     children.~   "
515|NCT03050437|"~     It has not been established whether platinum-based doublets is better than single agent~     chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.~      In this prospective trial, the investigators try to evaluate whether the progression-free~     survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P)~     regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.~   "
516|NCT03050424|"~     This phase II single centre, double blind, placebo-controlled, randomised trial aims to test~     the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive~     Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.~   "
517|NCT03050411|"~     Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib~     demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients~     with EGFR mutations. However, patients who are initially sensitive to the drugs eventually~     become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the~     angiogenesis of tumor efficiently. In this study, the investigators aim to explore the~     efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous~     non-small cell lung cancer with EGFR-TKI resistance.~   "
518|NCT03050398|"~     This study will allow for the collection of tumor tissue samples to better understand~     relevant mutations and the mechanisms responsible for resistance to treatment.~   "
519|NCT03050385|"~     The purpose of this study is to explore whether active transcranial direct current~     stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without~     severe side effects in mild cognitive impairment or mild dementia patients.~   "
520|NCT03050372|"~     Participants will be recruited and screened through ongoing studies in the sleep and anxiety~     disorders clinic. Participants with insomnia will be consented to complete several~     questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of~     active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study.~     Each of the two treatment conditions (active versus sham) will be conducted on two~     consecutive nights. There will be no more than 7 days between the adaptation night and the~     first treatment condition and no more than 7 nights between each of the two-night treatment~     conditions . Thus, each participant who completes the full study will spend a total of 5~     nights in the sleep laboratory and the time interval from the first adaptation night to~     completion of the study may range from 5-19 days for any particular individual.~   "
521|NCT03050359|"~     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus~     lansoprazole in the treatment of participants with duodenal ulcer.~   "
522|NCT03050346|"~     This is a clinical trial to test the clinical feasibility and safety of a novel CMR~     protocol, combined with a specific breathing maneuver to identify myocardial regions exposed~     to severe coronary artery stenosis.~   "
523|NCT03050333|"~     An observational, prospective, multicentre and international study. This will be a~     non-interventional study to evaluate the efficacy and safety of endoscopic resection of~     gastrointestinal lesions and to determine what are the factors related to complications, and~     to describe these lesions according to the different morphologic and histologic~     classifications.~   "
524|NCT03050320|"~     The purpose of this study is to examine the impact of an OA-specific aerobic and~     strengthening exercise program, delivered within the workplace, on mobility, pain, physical~     capacity, and resilience among workers with knee or hip OA as well as those with no joint~     pain. We hypothesize that exercise designed for OA, delivered at work, will improve all of~     these outcomes.~   "
525|NCT03050307|"~     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus~     lansoprazole in the treatment of participants with gastric ulcer.~   "
526|NCT03050294|"~     Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a~     significant amount of patients in most dermatological practices. Topical corticosteroid~     agents are often prescribed for treatment of both these conditions, especially when they are~     localized rather than wide spread. The development of resistance to treatment is termed~     tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary~     cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to~     determine, under conditions designed to assure good adherence, whether topical 0.25%~     desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory~     skin disease defined by failure of previous topical steroid treatment.~   "
527|NCT03050281|"~     Background: The use of simulation and cadaveric laboratory training are highly beneficial~     for faculty and advanced trainees, but its usefulness for third-year medical students~     rotating through OB-GYN or general surgery is unknown.~      Objective: To determine if a two-day intensive, cost-effective review of procedural skills~     and anatomy using the simulation laboratory and cadaver-based dissection improves~     performance of third-year medical students on the National Board of Medical Examiners (NBME)~     Shelf and USMLE Step 2 board examination and during pre- and post-test demonstrations.~      Significance: If proven effective, implementation of a short, inexpensive, and comprehensive~     course highlighting anatomical and procedural skills during the third year of medical school~     could be implemented.~      Design Methods: The investigators will conduct a 1:1 randomization of third-year medical~     students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students~     will either participate in traditional education (N=20) as is currently taking place or~     traditional education plus cadaver-based/simulation-based learning (N=20). Third-year~     medical students rotating in OB-GYN or surgery will be eligible to enroll.~      Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes~     will be improved and procedural skills and overall satisfaction will be increased.~   "
656|NCT03048591|"~     Through the research to confirm the effectiveness and safety of using electroacupuncture in~     the treatment of chemotherapy-induced peripheral neuropathy.~   "
2608|NCT03023072|"~     The purpose of this study is to determine if the sponsor's Incontinence Product reduces~     patient exposure time to a wet and/or soiled incontinence pad.~   "
528|NCT03050268|"~     While it is well recognized that hereditary factors contribute to the development of a~     subset of human cancers, the cause for many cancers remains unknown. The application of next~     generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary~     cancer predisposition. Currently, more than 100 cancer predisposing genes have been~     identified, and it is now estimated that approximately 10% of all cancer patients have an~     underlying genetic predisposition.~      The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic~     variants. For this study, the investigators will establish a Data Registry linked to a~     Repository of biological samples. Health information, blood samples and occasionally~     leftover tumor samples will be collected from individuals with familial cancer. The~     investigators will use NGS approaches to find changes in genes that may be important in the~     development of familial cancer. The information gained from this study may provide new and~     better ways to diagnose and care for people with hereditary cancer.~      PRIMARY OBJECTIVE:~        -  Establish a registry of families with clustering of cancer in which clinical data are~          linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues~          from the proband and other family members.~      SECONDARY OBJECTIVE:~        -  Identify novel cancer predisposing genes and/or genetic variants in families with~          clustering of cancer for which the underlying genetic basis is unknown.~   "
529|NCT03050255|"~     Although exercise-induced desaturation is frequently observed in patients with idiopathic~     pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not~     been investigated yet. Given, that walking ability is the most important activity of daily~     life, the aim of our study is to investigate the effects of supplemental oxygen on endurance~     walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance~     shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air~     (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a~     double-blinded fashion and random order.~      Since there are only limited pharmacological treatment options for IPF patients, this study~     may help to provide novel information about the short-term effects of supplemental oxygen.~     Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to~     facilitate patients´ participation in activities of daily life and not at least to improve~     patients´ quality of life.~   "
530|NCT03050242|"~     This study is intended to evaluate the efficacy and safety of glycopyrrolate as an~     antisialagogue prior to intubation with the rigid-videostylet(Optiscope®) in the general~     anesthesia settings. Upper airway secretions limit the use of the videostylet during during~     endotracheal intubation. Therefore, in this study, patients will be allocated to either of~     the two groups according to the administration of glycopyrrolate and the effect of~     glycopyrrolate in reducing oral secretions will be assessed by the observer while intubating~     with the rigid-videostylet. The efficacy of the antisialagogic effect on the view during~     endotracheal intubation will be evaluated.~   "
531|NCT03050229|"~     To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo +~     ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension~   "
532|NCT03050216|"~     This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted,~     ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after~     lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute~     myelogenous leukemia (AML).~   "
533|NCT03050203|"~     Recent evidence suggests the efficacy of custom pack procedure on the operators reduction~     time and on the contamination risk due to the opening of many sterile packs. Nevertheless~     ,the studies available are sponsored by the industry and their results are very few. The aim~     of this study is to evaluate the correlation and reliability of spine surgery custom pack~     efficacy in adult patients obtained in the reduction of surgery time, relative risks, and~     materials wasted compared with the standard surgical field procedure practice .~   "
534|NCT03050190|"~     The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor~     gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies.~     Clinical response and development of a standardized lentiviral vector and cell production~     protocol will be investigated. This is a phase I/II trial enrolling patients from multiple~     clinical centers.~   "
535|NCT03050177|"~     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence~     Study. During each session, the subjects will be administered a single dose of 250mg~     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of~     AstraZeneca) under fed conditions.~   "
536|NCT03050164|"~     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence~     Study. During each session, the subjects will be administered a single dose of 250mg~     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of~     AstraZeneca) under fasting conditions.~   "
537|NCT03050151|"~     To collect data on actual-use to assess technical performance and user injections of~     dupilumab auto-injection device by patients with atopic dermatitis (AD).~   "
538|NCT03050138|"~     The primary objective in this cross-sectional study is to assess the prevalence of~     post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin~     versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta~     (PRV) Score.~      Secondary objectives: to assess in both treatment arms the~        1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study~          treatment.~        2. Prevalence of PTS determined by the standard Villalta score.~        3. Health related Quality of Life (HRQoL).~   "
539|NCT03050125|"~     This pilot study will investigate the impact of sterile saline drops that are formulated at~     hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of~     symptomatic CL wearers.~   "
561|NCT03049839|"~     The main aim of this study is to evaluate the feasibility and effectiveness of a program for~     modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk~     factors in adults with different categories of risk from the primary health care strategy.~      The project will show the effect of these interventions for the first time in people With~     different risk of developing type 2 diabetes throughout the life in populations living in~     Colombia Located in 2 different cities, one of them in the interior of the country~     (districts of Bogota) and another in the north coast (districts of Barranquilla) .~   "
540|NCT03050112|"~     Adults with a congenital heart disease, having undergone a surgical intervention or a re-do~     surgery in adulthood, are a growing group of subjects in the general population. This~     increase is explained by improved medical and surgical techniques, with a better survival~     rate as outcome.~      There is nowadays a growing interest in the quality of life of this group of subjects.~     However, studies give contradictory results. This can be explained on one hand by the vast~     majority of pathologies within this population, and on the other hand by the absence of a~     cardio-specific tool for quality of life measurement.~      The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life~     based on the exploration of three domains: physical, emotional and social.~      The aim of this study is:~        -  to evaluate the quality of life of these patients, by using the MacNew questionnaire~        -  to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up~        -  to assess the mortality within this group of patients.~   "
541|NCT03050099|"~     A multi-protein test using mass spectrometry (MS) for multiplexed protein quantitation is~     being developed. This test and the accompanying decision-aid software will provide Transient~     Ischemic Attack (TIA) results rapidly for a fraction of the price of neuroimaging. With~     guidance provided by this test, Emergency Department (ED) physicians can manage medical~     imaging questions such as the use of Computed Tomography Angiography (CTA) prior to ED~     discharge and appropriate (timely) referral to stroke clinics for consultation and follow-up~     care. The right patients will receive the right treatment, reduce unwarranted imaging risks~     and costs, and reduce the burden of stroke.~   "
542|NCT03050086|"~     An open label feasibility study using BPX-01 topical minocycline gel in papulopustular~     rosacea.~   "
543|NCT03050073|"~     A chinese study shows that chinese population eyes with a primary angle closure have a~     greater choroidal thickness than normal eyes.The increase of choroidal thickness would be~     associated to this primary angle closure.~   "
544|NCT03050060|"~     This phase II trial studies how well image guided hypofractionated radiation therapy works~     with nelfinavir mesylate and nivolumab in treating patients with melanoma, lung cancer, or~     kidney cancer that has spread. Hypofractionated radiation therapy delivers higher doses of~     radiation therapy over a shorter period of time and may kill more tumor cells and have fewer~     side effects. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with~     the ability of tumor cells to grow and spread. Giving hypofractionated radiation therapy,~     nelfinavir mesylate, and nivolumab may work better in treating patients with melanoma, lung,~     or kidney cancer.~   "
545|NCT03050047|"~     A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics,~     Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients~     with Advanced Solid Tumors~   "
546|NCT03050034|"~     The present study was planned to provide clinical data on the impact of acute and critically~     ill patients in Internal Medicine Unit activity and economic data enabling to quantify the~     relative cost of acute patients management during ordinary hospitalization. In these~     critically ill complex patients the vital parameters continuous monitoring could help in~     improving the quality of care. Therefore, the study will check how the wireless continuous~     monitoring in acute selected patients is able to reduce major complications improving the~     patient's outcome and the quality of care and reducing costs compared to traditional~     monitoring performed at regular intervals by the nursing staff.~   "
547|NCT03050021|"~     Delirium is characterized by changes in mental status, inattension, disorganized thinking,~     and altered consciousness. Prevalence of delirium in critically ill patients has varied from~     20~80% depending on the severity of illness. Despite its high prevalence, delirium is often~     under-recognized by clinicians due to the difficulties in diagnosis and no interest.~     Delirium is associated with increased mechanical ventilation days, hospital length of stay,~     and mortality. The purpose of this study is to analyze the prevalence of delirium and risk~     factors for delirium in critically ill surgical patients.~   "
548|NCT03050008|"~     Despite the advantages already demonstrated by FLACS, these surgeries still require~     ultrasonic devices for fragmentation of the lens. The ultrasonic energy used during~     phacoemulsification may induce complications such as reduction of endothelial cells and~     corneal edema. In this sense, it would be beneficial to develop surgical techniques that~     eliminate the need for ultrasound. The group of surgeons of Alfredo Tranjan Ophthalmic~     Center, recently developed a surgical technique of cataract that optimizes the use of the~     laser, eliminating the need for ultrasound during the surgical procedure. Thus, the~     crystalline fragmentation process does not involve ultrasound being performed by the laser~     itself. It is expected that this procedure will reduce the complexity of cataract surgery,~     and be safer in terms of potential corneal lesions. The present study intends to evaluate~     the benefit and safety of FLACS without use of ultrasound (USFREE), compared to traditional~     phacoemulsification surgery using ultrasound in patients with senile cataract. In this~     sense, it is intended to primarily compare the volume of balanced saline solution (BSS)~     between surgeries.~   "
562|NCT03049826|"~     Background: There are few studies about nutrition to children and adolescents with cancer,~     and in particular during stem cell transplantation (SCT). Studies from other countries~     suggest that malnutrition is common on admission; the situation decline during treatment and~     may persist for a long time.~      Aim: This project aims to improve the nutritional therapy to children being treated for~     cancer and children undergoing stem cell transplantation~   "
563|NCT03049813|"~     This is a randomized controlled trial to evaluate the community-based effectiveness of~     virtual reality job interview training (VR-JIT). Northwestern University is partnering with~     Thresholds Inc. to evaluate the effectiveness of VR-JIT at improving interviewing skills and~     access to employment. In addition, we will evaluate the cost effectiveness of VR-JIT and the~     process for implementing VR-JIT at Thresholds.~   "
564|NCT03049800|"~     The purpose of this study is to perform longitudinal high-resolution 7T MRI in participants~     with first-episode psychosis (FEP) enrolled in our ongoing randomized controlled clinical~     trial (RCT) of cognitive training. The investigators seek to determine whether a 12-week~     course of intensive cognitive training of auditory processing in young FEP patients~     delivered remotely as a stand-alone treatment is neuroprotective against neural tissue loss~     in auditory cortex (superior temporal gyrus, STG), and possibly in other cortical regions.~     The investigators will also observe the effects of training on white matter integrity in the~     brain.~   "
549|NCT03049995|"~     Background: Stress echocardiography (SE) has an established role in evidence-based~     guidelines, but recently the breadth and variety of applications has extended well beyond~     coronary artery disease (CAD). Purpose: To establish a prospective research study of SE~     applications, in and beyond CAD, also considering a variety of signs in addition to regional~     wall motion abnormalities. Methods: In a prospective, multicenter, international,~     observational study design, > 100 certified high-volume SE labs will be networked with an~     organized system of clinical, laboratory and imaging data collection at the time of physical~     or pharmacological SE, with structured follow-up information. The study is endorsed by the~     Italian Society of Echocardiography and organized in 10 subprojects focusing on: contractile~     reserve for prediction of cardiac resynchronization or medical therapy response; stress~     B-lines in heart failure; hypertrophic cardiomyopathy; heart failure with preserved ejection~     fraction; mitral regurgitation after either transcatheter or surgical aortic valve~     replacement; outdoor SE in extreme physiology; right ventricular contractile reserve in~     repaired tetralogy of Fallot; suspected or initial pulmonary arterial hypertension; coronary~     flow velocity, left ventricular elastance reserve and B-lines in known or suspected CAD;~     identification of subclinical familial disease in phenotype-negative healthy relatives of~     inherited disease (such as hypertrophic cardiomyopathy). Expected Results:To collect about~     10,000 patients over a 5-year period (2016-2020), with sample sizes ranging from 5,000 for~     known or suspected CAD to around 250 for hypertrophic cardiomyopathy or repaired Fallot.~     This data base will allow to investigate technical questions such as feasibility and~     reproducibility of various SE parameters and to assess their prognostic value in different~     clinical scenarios. Conclusions: The study will create the cultural, informatic and~     scientific infrastructure connecting high-volume, accredited SE labs, to obtain original~     safety, feasibility, and outcome data in evidence-poor diagnostic fields, also outside the~     established core application of SE in CAD based on regional wall motion abnormalities. The~     study will standardize procedures, validate emerging signs, and integrate the new~     information with established knowledge, helping to build a next-generation SE lab without~     inner walls.~   "
550|NCT03049982|"~     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner~     in its intended setting. Participants with obstructive sleep apnea will use the device to~     determine their eligibility for oral appliance therapy and provide feedback on usability of~     the device.~   "
551|NCT03049969|"~     The proposed study will test the feasibility and tolerability of transcranial direct current~     stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 20~     cognitive remediation sessions, participants will receive 20 minutes of active tDCS~     stimulation (up to 2.0 mA, dorsolateral prefrontal cortex or DLPFC montage) while they~     complete the cognitive training tasks.~   "
552|NCT03049956|"~     Myasthenia gravis is an autoimmune disorder of neuromuscular transmission, characterized by~     fluctuating muscle weakness and fatigability. In isolated ocular myasthenia, when only the~     extraocular muscles are involved, most common ancillary tests, such as acetylcholine~     receptor autoantibodies and repetitive nerve stimulation, are often negative.~      A simple, quick and non-invasive test for ocular myasthenia based on ocular vestibular~     evoked myogenic potentials (oVEMP) was recently developed.~      The main goal of the study is to validate repetitive oVEMP stimulation in a blinded~     diagnostic accuracy study in order to facilitate early and accurate diagnosis of ocular~     myasthenia.~   "
553|NCT03049943|"~     The aim of this study was to compare the effects of different wave lengths of LLLT on~     salivation in participants suffering from hyposalivation.~      This study included 30 participants whose major salivary glands were treated with low~     intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10~     consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and~     treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and~     stimulated saliva was measured each day during 10 days, before and after laser treatment and~     10th day after treatment was ended.~   "
554|NCT03049930|"~     The purpose of this study is to determine whether a low-dose ketamine infusion can be used~     as the main intra-operative analgesic in different burn patients, and thereby reduce the~     total intra-operative opioid requirement. Secondary objectives are to determine whether this~     low-dose ketamine infusion will lengthen the amount of time to the first narcotic given in~     the recovery room or ICU, and whether pain scores for awake patients will be lower~     post-operatively.~   "
555|NCT03049917|"~     The purpose of this study is to determine whether giving small financial incentives will~     motivate parents to test their children for HIV.~   "
556|NCT03049904|"~     This is a pilot study of the feasibility of the virtually reality, online, culturally~     grounded HIV prevention intervention for Native American men who have sex with men. The~     project will include 90 Native American men who have sex with men (MSM) from across the~     continental United States as well as Alaska and Hawaii.~      The investigators will use a randomized clinical trial with a waitlist control condition to~     evaluate the intervention's impact on HIV / Sexually Transmitted Infections (STI) testing~     behavior, condom use, and substance use harm reduction. Specifically, investigators will ask~     participants to spend 3 weeks exploring a virtual reality environment hosted in the Second~     Life® platform. The island consists of 3 levels: Learning Level, Skills building level, and~     Experiential level.~      In the Learning level the participant's avatar will have the opportunity to attend up to 2~     free Motivational Interviewing sessions to establish their goals for their time on the~     island. Additionally, they will explore 4 learning paths each covering a knowledge~     objective: HIV Testing, Condom Use & Condom Use Negotiation, Safer Sex, and Harm Reduction.~     Each path will present knowledge via videos, interactive games, stories, and teachings.~     After completing level 1, participants will move on to the Skills building level. Here~     participants will have the opportunity to role play scenarios (e.g., obtaining an HIV test,~     requesting PrEP from their doctor, negotiating condom use) with pre-program virtual actors.~     All scenarios are based on the knowledge gained in the Learning Level. Participants will~     also engage on mini-quests for additional knowledge and in-world rewards. Finally, in the~     third level participants will be able to practice the skills learned in interactions with~     other participants' avatars.~      If efficacious, this online HIV prevention intervention has the potential for widespread~     dissemination and could be particularly helpful for rural and reservation-based Native MSM~     who often have difficulty accessing services and support.~   "
557|NCT03049891|"~     The decentralization study will describe children taking antiretroviral therapy (ART) at a~     larger health facility in the Eastern Cape province of South Africa, between the years of~     2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure~     how many children stay in care and how many die, as well as their health status. The study~     will also compare whether children do better if they stay in care a large hospitals or if~     they get health care at smaller clinics. A second part of the study will find children in~     the community who have stopped coming for health care and find out what happened to them and~     what their health status is.~   "
558|NCT03049878|"~     Objectives:~      The aim of this study was to determine the effectiveness of preoperative administration of~     single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the~     surgical removal of an impacted mandibular third molar.~      Materials and Methods:~      The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral~     symmetrical impacted mandibles. Patients were randomized in two experimental groups to~     receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo~     (placebo group) at the first and second surgeries. Study participants were asked to record~     pain intensity scores during the operation and the next 2 days, the time of the first~     request for rescue analgesic, and the total number of postoperative-supplement~     paracetamol-codeine tablets.~   "
568|NCT03049748|"~     The purpose of this study is to evaluate the use of VAD Care App in an out-patient~     mechanical circulatory support program. The specific aim for this pilot study is to obtain~     preliminary efficacy data of the VAD Care App as a self-management tool for patients with~     long-term LVADs. A randomized control trial will be employed to establish preliminary~     estimates of the effects of the App on the following outcomes: (1) patients' and caregivers'~     self-efficacy and (2) adherence to the LVAD care regimen; (3) LVAD-related complications and~     health care utilization [e.g., hospital re-admission]; and (4) the patients' overall health~     status and (5) quality of life. The duration of the study is 6 months.~   "
569|NCT03049735|"~     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once~     daily co-administered with low dose estradiol and norethindrone acetate compared with~     placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.~     Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily~     for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low~     dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same~     population.~   "
570|NCT03049722|"~     The purpose of this study is to collect clinical data for the development and evaluation of~     a new device feature for automatic AV-delay (AVD) optimization.~   "
571|NCT03049709|"~     There is growing evidence that central blood pressure is a better predictor of hypertensive~     end-organ damage and cardiovascular outcome than routine brachial readings.~      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive~     determination of central blood pressure based on automated oscillometric radial pulse wave~     analysis.~   "
572|NCT03049696|"~     The primary objective of the study is to determine whether participation in a pre-bariatric~     surgery physical activity and behavior modification/education program (ENCOURAGEING START)~     that is tailored to the unique needs of obese bariatric surgery patients, improves physical~     fitness, surgical outcomes, patient health and quality of life. Short- (one year) and long-~     (five year) term outcomes will be compared to matched historical controls (1:1) based on~     age, gender, and body mass index (BMI) from the existing Manitoba Centre for Metabolic and~     Bariatric Surgery (CMBS) database. Our findings will determine whether a pre-bariatric~     surgery physical activity and behavior modification/education program results in improve~     surgical and patient outcomes and inform the development of evidence-based physical activity~     (PA) guidelines for bariatric surgery patients and improved CMBS program delivery.~   "
573|NCT03049683|"~     To lower the threshold for clinical application by reducing the testing time for recording~     vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording~     of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved~     without a loss in diagnostic sensitivity.~   "
574|NCT03049670|"~     Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The~     aim of this study is to elaborate the effectiveness and safety of this solution.~   "
575|NCT03049657|"~     Clinical trial with an European Community marked medical device in patients with ischemic~     heart disease and clinical indication of coronary revascularization with drug-eluting stent.~      Clinical follow-up will be done according to this way: first month telephone or face-to-face~     interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)~      A randomized clinical trial to compare the efficacy of Angiolite Stent versus a~     second-generation drug-eluting stent such as Xience stent.(non-inferiority design)~   "
576|NCT03049644|"~     Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated~     efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study~     will allow for comparison of these two treatment modalities in a clinical setting. The~     purpose of this study is to demonstrate the feasibility of recruiting, enrolling and~     collecting outcome data on CLBP patients utilizing the POC methodology.~   "
577|NCT03049631|"~     The primary objective aims are to assess the effects of regular consumption of red~     raspberries (RRB) with and without fructooligosaccharide (FOS) on the composition of the gut~     microbiota after 4 week intake and in parallel characterize plasma and urine metabolite~     profiles examining qualitative and quantitative intervention associated changes.~   "
578|NCT03049618|"~     This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab~     work in treating patients with non-small cell lung cancer that has spread to other places in~     the body or head and neck squamous cell cancer that has come back or spread to other places~     in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving~     recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients~     with non-small cell lung or head and neck squamous cell cancer.~   "
579|NCT03049605|"~     This study are to:~        -  Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.~        -  Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.~        -  Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy~          in diabetic patients.~   "
580|NCT03049592|"~     High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the~     Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS)~     is a collaborative study utilizing qualitative methods to assess the acceptability including~     a family planning specialist's postpartum contraception counseling during and after prenatal~     care among Latina obstetric women with pre-gestational diabetes. The investigators will~     compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting~     Reversible Contraception (LARC) use at 3 months postpartum.~   "
657|NCT03048578|"~     This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo~     over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y~     gastric bypass (RYGB) who are experiencing weight regain. This study will assess the~     efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum~     lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient~     Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are~     experiencing weight regain as well as the safety of liraglutide in this patient population.~   "
658|NCT03048565|"~     This is a pilot feasibility study testing a mindfulness based intervention with caregivers~     of people with chronic illnesses~   "
581|NCT03049579|"~     The purpose of this study is to investigate the effects of a probiotic supplementation on~     adult volunteers with having caught the common cold more than 4 times in the past year. This~     study is a single center, double-blind, randomized, controlled, parallel-designed,~     prospective trial. Subjects received a probiotic drink containing probiotics of~     Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431®~     (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without~     probiotics for a 12-week study period.~      The incidence of flue and cold during the study period were compared between study groups.~      Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal~     samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was~     drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin~     A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.~   "
582|NCT03049566|"~     This study aims to assess independent factors associated with the clinical decision to~     discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.~   "
583|NCT03049553|"~     In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering~     the cervical screening program. These women are expected to be better protected against~     cervical cancer. It has not yet been decided how to screen these women.~      This method study will investigate a possible screening scheme that could provide a reduced~     burden of screening for HPV-vaccinated birth cohorts.~   "
584|NCT03049540|"~     This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot~     trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function,~     exercise capacity and neurohumoral activation in adults with congenital heart disease and a~     right ventricle in subaortic position over a 3-year follow-up period.~   "
585|NCT03049527|"~     The objective of this research project is to investigate specific behaviors and exposures~     related to sugarcane work and their association with non-communicable diseases, specifically~     Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over~     the course of the 6-month sugarcane harvest the investigators will assess risk factors for~     declining kidney function, and also changes in biomarkers of kidney function pre and post~     work shift of field and factory workers and their possible relationships with dehydration~     and heat stress. The investigators will also evaluate the effectiveness of an intervention~     aimed at increasing hydration and reducing heat stress. Finally the investigators will~     measure biomarkers of exposure and environmental samples for heavy metals, agrochemicals,~     and infectious disease (Leptospira).~   "
586|NCT03049514|"~     Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at~     the retinal level. They share the same risk factors and common pathology. Their incidence is~     lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with~     visual acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden~     occurrence of a decrease in deep visual acuity with fundamentally signs of reactive~     ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the~     relationship between early recanalization (spontaneous or post-thrombolysis) and visual~     prognosis.~   "
587|NCT03049501|"~     The prevalence of family caregivers is projected to increase in concert with the projected~     increase in number of AD patients. The focus of the study is to gather systematic data on~     the acceptability and efficacy of a unique technology-based, culturally- tailored~     psycho-social intervention program that targets ethnically/culturally diverse family~     caregivers of patients with Alzheimer's Disease. The overall goal of the project is to~     improve the lives of family caregivers as well as their ability to provide care to their~     loved one and to reduce disparities in access to needed services and support among caregiver~     populations.~   "
588|NCT03049488|"~     Background:~      RSV is a virus that infects the lungs and breathing passages. Healthy adults who are~     infected generally have mild cold symptoms for a week or two. But it can also be serious,~     especially for infants and older adults. It can be spread by direct or indirect contact with~     respiratory secretions. Researchers want to study a new vaccine to prevent RSV.~      Objective:~      To see if a vaccine for RSV is safe and if it causes side effects.~      Eligibility:~      Healthy adults 18 50 years old~      Design:~      Participants will be screened in a different protocol.~      Participants will have 13 visits over 1 year.~      Some participants will receive just vaccine. Some will receive vaccine mixed with alum,~     which could make the body respond to the vaccine better.~      All will receive their dose by injection in the upper arm. They will receive two doses, one~     at the beginning of the study and another 12 weeks later.~      Participants will be watched for 1 hour after injection. They will be called 1 day after.~      They will keep track of their temperature and side effects for 7 days after.~      Participants will receive a ruler to measure any changes on their skin at the injection~     site.~      At all visits, participants will be checked for health changes or problems. They may have~     blood drawn.~      At some visits, participants will have samples taken from their nose and mouth.~   "
589|NCT03049475|"~     Background:~      Sickle Cell Disease (SCD) is a blood disorder that occurs mainly in people of African~     descent. Researchers want to learn more about the painful attacks and complications~     associated with SCD. They want to look for a relationship between SCD and specific changes~     in the blood. They want to study the role of genetics, inflammation, and blood clotting~     factors in SCD. They will do this with blood samples collected during an acute painful~     attack and in between attacks.~      Objective:~      To learn more about the painful attacks and complications associated with SCD.~      Eligibility:~      People ages 18-80 with SCD or who are healthy Africans or African Americans without SCD~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Healthy participants will have one visit.~        -  Participants with SCD will have their first visit when they are not having a pain~          attack. They will have their next visit during a pain attack. About 3-4 months after~          this attack, they will have a final visit.~        -  Visits will include a physical exam, and blood and urine tests.~        -  Participants may have their blood samples used for genetic testing for research.~   "
672|NCT03048383|"~     The purpose of this study is to compare the effectiveness of three commercially available~     botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported~     outcome measures.~   "
3330|NCT03013634|"~     The purpose of this study was to evaluate the protective effect of dexmedetomidine on~     myocardial injury during liver transplantation~   "
590|NCT03049462|"~     Background:~      Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve~     insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body~     burn energy.~      Objective:~      To learn more about how BAT works to burn energy.~      Eligibility:~      Healthy people ages 18 40 with a body mass index between 18 and 40~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Dietitian interview~      Participants will have an overnight baseline visit. This includes:~      Repeats of screening tests~      Exercise test~      Scans. For one scan, a radioactive substance is injected into the arm.~      FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are~     injected in one arm. Blood glucose and insulin levels are measured from the other.~      Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate.~     Monitors on the body measure heart rate, movement, and temperature.~      Optional fat biopsy: A small piece of tissue is removed with a needle.~      Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron.~     Men will be randomly get either the drug or a placebo.~      All participants will have a visit after 2 weeks of the pills. They will repeat the~     screening tests.~      Participants will have an overnight visit 2 weeks later. They will repeat the baseline~     tests.~      Participants will keep food and medication diaries.~      Participants will have a follow-up visit 2 weeks after stopping the pills. This includes~     heart tests.~   "
591|NCT03049449|"~     Background:~        -  Improved treatments for a variety of treatment-resistant, CD30-expressing malignancies~          including Hodgkin lymphoma, anaplastic large cell lymphoma, and other CD30- expressing~          lymphomas are needed.~        -  T cells can be genetically modified to express chimeric antigen receptors (CARs) that~          specifically target malignancy-associated antigens.~        -  Autologous T cells genetically modified to express CARs targeting the B-cell antigen~          CD19 have caused complete remissions in a small number of patients with lymphoma. These~          results demonstrate that CAR-expressing T cells can have anti-lymphoma activity in~          humans.~        -  CD30 expression can be easily detected by immunohistochemistry on lymphoma cells, which~          allows selection of CD30-expressing malignancies for treatment.~        -  CD30 is not known to be expressed by normal cells except for a small number of~          activated lymphocytes and decidual cells in the pregnant uterus.~        -  We have constructed a novel fully-human anti-CD30 CAR that can specifically recognize~          CD30-expressing target cells in vitro and eradicate CD30-expressing tumors in mice.~        -  This particular CAR has not been tested before in humans.~        -  Possible toxicities include cytokine-associated toxicities such as fever, hypotension,~          and neurological toxicities. Elimination of a small number of normal activated~          lymphocytes is possible, and unknown toxicities are also possible.~      Objectives:~      Primary~      -Determine the safety and feasibility of administering T-cells expressing a novel fullyhuman~     anti-CD30 CAR to patients with advanced CD30-expresssing lymphomas.~      Eligibility:~        -  Patients must have Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell~          lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise~          specified, primary mediastinal B-cell lymphoma, grey zone lymphoma,~          enteropathyassociated T-cell lymphoma, or extranodal NK/T-cell lymphoma, nasal type~        -  Patients must have malignancy that is both measurable on a CT scan with a largest~          diameter of at least 1.5 cm and possessing increased metabolic activity detectable by~          PET scan. Alternatively patients with lymphoma detected by flow cytometry of bone~          marrow~      are eligible.~        -  Patients must have a creatinine of 1.4 mg/dL or less and a normal cardiac ejection~          fraction.~        -  An ECOG performance status of 0-1 is required.~        -  No active infections are allowed including any history of HIV, hepatitis B, or~          hepatitis C. Patients must be seronegative for CMV by blood PCR.~        -  Absolute neutrophil count greater than or equal to 1000/micro L, platelet count greater~          than or equal to 45,000/micro L, hemoglobin greater than or equal to 8g/dL~        -  Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal~          unless liver involvement by malignancy is demonstrated.~        -  At least 14 days must elapse between the time of any prior systemic treatment~          (including corticosteroids) and initiation of protocol enrollment.~        -  Clear CD30 expression must be detected on 75% or more of malignant cells from either~          bone marrow or lymphoma mass by flow cytometry or immunohistochemistry. The patient s~          malignancy will need to be assessed for CD30 expression by flow cytometry or~          immunohistochemistry performed at the NIH. If unstained, paraffin-embedded bone marrow~          or lymphoma sections are available from prior biopsies, these can be used to determine~          CD30 expression by immunohistochemistry; otherwise, patients will need to come to the~          NIH for a biopsy to determine CD30 expression. The sample for CD30 expression can come~          from a biopsy obtained at any time before enrollment, unless the patient has received a~          prior anti-CD30 monoclonal antibody, in which case the sample must come from a biopsy~          following completion of the most recent anti-CD30 monoclonal antibody treatment.~        -  Eligible patients with Hodgkin lymphoma must fulfill one of the following criteria: 1)~          have received two prior therapies, one of which must be an autologous stem cell~          transplant, or 2) have received three prior lines of therapy. Eligible patients with~          any of the listed peripheral T cell lymphomas or non-Hodgkin lymphomas must have~          received two lines of prior therapy, at least one of which must contain cytotoxic~      chemotherapyPatients with diffuse large B-cell lymphoma or primary mediastinal B-cell~     lymphoma must have received 2 prior treatment regimens at least 1 of which included an~     anthracycline and an anti-CD20 monoclonal antibody.~        -  Patients who have never had an allogeneic hematopoietic stem cell transplant as well as~          patients who have had an HLA-matched sibling or a 8/8 HLA-matched unrelated donor~          hematopoietic stem cell transplant are potentially eligible.~        -  Women who are pregnant or plan to become pregnant will be excluded. Due to the risk of~          damage to normal uterine tissue during the secretory phase of menstruation, w......~   "
592|NCT03049436|"~     Physical activity has demonstrated efficacy in cancer prevention and improves quality of~     life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those~     with advanced disease, may have symptoms leading to inactivity. Adapted physical activity~     (APA) among those patients could improve their tolerance to the treatment, and thereby their~     quality of life. APA could be beneficial to patients with curable disease as well as~     patients undergoing palliative chemotherapy. Some studies suggest that fighting against loss~     of muscle mass could lead to a survival benefit. However, APA is not established in daily~     practice and has not yet been evaluated in a chemotherapy ambulatory care unit.~      Primary aim of the study is to assess feasibility of an APA program in a chemotherapy~     ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary~     aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip~     strength in patients beginning chemotherapy or targeted therapy for a digestive, lung,~     hematological or dermatological cancer, of any stage.~   "
593|NCT03049423|"~     To compare the results of multi-position MRI scans for ankle ligaments and tendons to~     clarify how to obtain imaging data of different ankle ligaments and define severity of~     injuries to calculate the rate of correct diagnosis, thereby developing a reasonable~     surgical treatment in clinical practice.~   "
594|NCT03049410|"~     This is a prospective multicentre randomised controlled trial comparing the outcomes from~     Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder~     cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or~     muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment~     of bladder cancer. The time of interest for measurement of the primary outcomes will be 90~     days post-surgery.~      Eligible patients will include those receiving neo-adjuvant chemotherapy (typically~     gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder~     reconstruction.~      Patients who have selected radical cystectomy after appropriate counselling and following a~     specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to~     consent for this study.~      Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be~     followed for a minimum of 90 days post-surgery.~      The study will be conducted in NHS Trusts designated as Cancer Centres. Patients will be~     stratified by~        -  Type of urinary diversion (Continent diversion or ileal conduit)~        -  Performance status~        -  Centre Trial assessments will be conducted at baseline (before surgery), whilst~          participants are on admission and then 5, 12, 24 weeks and 1 year post surgery.~   "
595|NCT03049397|"~     This pilot clinical trial studies how well the Enhancing Connections program improves family~     adjustment in patients with incurable cancer. Participating in an educational program with a~     co-parent to learn about ways to talk to a child about cancer may help parents and~     co-parents support their child with the parent's cancer and may help families communicate~     and function better.~   "
596|NCT03049384|"~     Fatigue is a common and distressing symptom in cancer survivors. Cancer-related fatigue is~     relieved with physical activity but the mechanisms for this are not well understood. The~     investigators hypothesize that a tailored and individualized exercise intervention will~     reduce cancer-related fatigue more than a classical exercise intervention. This study is~     designed to investigate the causes of fatigue with whole-body exercise and their relation to~     self-reported measures of fatigue before and after an exercise intervention.~   "
597|NCT03049371|"~     The current study will explore behavioral, surgical and biological neovaginal and rectal HIV~     transmission risks and feasibility of collection of blood and ano-genital samples (rectal,~     genital and neo-vaginal, including urine) for microbiological, immunological and cytological~     characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV~     infection in TGW. This includes the feasibility of home self-collection of ano-genital~     samples prior to habitual cleansing of the anatomical collection site.~   "
598|NCT03049358|"~     This randomized phase I trial studies how well olfactory training works in improving sense~     of smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.~     Olfactory training may improve smell function after radiation therapy in patients with~     paranasal sinus or nasopharyngeal cancer.~   "
673|NCT03048370|"~     This study aims to determine if individuals with schizophrenia have greater reactivity to~     vestibular stimulation than healthy controls. The physiological response of vestibular~     stimulation will be assessed with electronystagmography, which provides a measure of the~     intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular~     system reactivity to vestibular stimulation may be a biomarker of schizophrenia.~     Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect~     abnormal vestibular function or impaired central suppression of the vestibular ocular~     reflex.~   "
3531|NCT03011021|"~     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo~     expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune~     diabetes.~   "
599|NCT03049345|"~     Gastric cancer has an incidence in North America of over 24,000 new cases annually, of which~     approximately 15% are diagnosed at an early stage. Standard of care for early gastric cancer~     (EGC) treatment has historically included anatomical resection with regional~     lymphadenectomy. However, with the recent emergence of organ-sparing techniques, select~     patients with a very low risk of lymph node metastases are able to avoid anatomical~     resection and its inherent short and long term consequences. Despite this advance, EGC~     patients with high risk features continue to require anatomical resection to achieve~     adequate lymph node staging, despite the fact that 75-95% of these patients ultimately are~     found to have node negative disease. Due to the inadequacy of standard imaging modalities to~     reliably detect nodal metastases in EGC patients, sentinel lymph node sampling for gastric~     cancer was developed using principals similar to those used broadly for breast and melanoma~     patients. Early reports from Asia suggest this technique has very high success rates,~     accuracy and sensitivity, however it has never been verified in a North American context.~     This study aims to test SLN sampling for North American gastric cancer patients at a high~     volume regional treatment centre, with an aim to expand the application of organ sparing~     resection to EGC patients.~      This project aims to determine the sensitivity and accuracy of sentinel lymph node sampling~     for early gastric cancer patients at a high volume, North American, tertiary care centre.~   "
600|NCT03049332|"~     This project is to develop a culturally sensitive and feasible self- and family-management~     intervention that will assist HIV+ Chinese women and their families to manage the illness~     and improve quality of life and clinical outcomes.~   "
601|NCT03049319|"~     Psoriasis affects 2-3% of the American population. While a wide variety of therapies~     currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant~     and retinoid agents a better understanding of phototherapy is needed. Given the prevalence~     of localized psoriasis and dissatisfaction with treatment, investigation of localized~     treatment should be a priority for researchers with goals to improve the current standard of~     care.~   "
602|NCT03049306|"~     The primary objective in this study is to test whether propranolol lowers glucose and free~     fatty acid levels during sleep in obstructive sleep apnea (OSA), and preserves vascular~     function (EndoPAT) versus placebo. The secondary objective is to test whether propranolol~     influences sleep quality, architecture, and hemodynamics in OSA. OSA will be elicited by~     temporarily discontinuing CPAP therapy in patients with a history OSA accustomed to CPAP~     therapy (CPAP withdrawal).~   "
603|NCT03049293|"~     To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and~     morpho-genetics.~      The reason to measure Midazolam levels in larger size follicles in this study is to maximize~     the chances to get a mature oocyte and therefore develop into a potential embryo to be~     analyzed.~   "
604|NCT03049267|"~     Study design: A double-blind randomised placebo-controlled trial~      Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen~     patients will be randomized to apremilast and five patients to placebo. The total duration~     of the treatment period per subject is 16 weeks.~      Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS~     lesional skin at week four (t=4) and week sixteen (t=16):~        -  of patients receiving apremilast compared to placebo;~        -  within both groups relative to baseline (t=0).~      Secondary objectives:~        -  To prospectively evaluate the clinical efficacy of apremilast.~        -  To assess the effect of apremilast on patient reported outcomes measures.~        -  To assess the short-term safety and tolerability of apremilast in patients with~          hidradenitis suppurativa.~   "
605|NCT03049254|"~     Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the~     heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or~     death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very~     difficult as the disease process can be subtle, but sufficient enough, so that the first~     event is sudden death.~      The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and~     Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to~     enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from~     the US and UK. Family members who are blood-relatives will also be invited, including those~     who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI,~     Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.~      Objectives of the study:~        1. Discover new genes or altered genes (variants) which cause AVC~        2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c)~          and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial~          fibrillation)~        3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally~          using clinical, electrocardiographic and imaging data.~        4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with~          gold-standard endomyocardial biopsies~   "
606|NCT03049241|"~     Potential factors involved in neuromuscular fatigue were classified into two categories: 1)~     central factors involving the central nervous system and neural pathways, and 2) peripheral~     factors occurring within the muscle beyond the neuromuscular junction. In adults, it has~     been shown that peripheral factors contribute to a large part of the fatigue induced by~     repeated maximal contractions. However in children, central factors could account for the~     development of fatigue to a greater extent. Force-generating capacity and musculotendinous~     stiffness could be two of the discriminatory factors accounting for the differences in the~     neuromuscular fatigue between children and adults.~      Force production capacity and musculotendinous stiffness vary as function of muscle length.~     Naturally, they could differ depending on the muscle groups studied. The main aim of the~     present protocol is to compare the effect of knee extensors and ankle plantarflexors length~     on the development and aetiology of neuromuscular fatigue, in children and adults. The~     investigators formulated the hypotheses that at short muscle length force and low~     musculotendinous stiffness, differences in force between children and adults would be~     reduced. Thus neuromuscular fatigue development and aetiology would be similar between both~     groups. The results of the present protocol will allow to better understanding of the~     aetiology of neuromuscular fatigue in children and help improving training or rehabilitation~     programs.~   "
674|NCT03048357|"~     Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated~     Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours~     on a standard Hospital Bed.~   "
607|NCT03049228|"~     It has been suggested that mitochondrial dysfunction might play a role in the development of~     diabetic cardiomyopathy. From animal studies, it has been suggested that an altered PPAR and~     PGC1 expression is involved in the reduced cardiac mitochondrial function, however human~     data on cardiac mitochondrial function and PPAR regulation is scarce. The latter is due to~     the fact that there is no validated measurement for assessing cardiac mitochondrial function~     non-invasively in vivo. It has been suggested that measuring PCr/ATP ratio with 31P-MRS in~     the heart reflects cardiac mitochondrial function. However, so far no direct validation of~     this method has been performed. The aim of this study will be to validate in vivo 31P-MRS~     with ex vivo measurements of mitochondrial function. To this end, the hypothesis is that in~     vivo 31P-MRS is a valid method for measuring cardiac mitochondrial function when compared~     with ex vivo mitochondrial respirometry.~   "
608|NCT03049215|"~     The study hypothesis is that placement of LAMS plus an overlapping double pigtail stent for~     endoscopic transmural drainage of PFCs with solid debris will result in improved drainage~     and require fewer endoscopic interventions compared to placement of LAMS alone.~   "
609|NCT03049202|"~     Obstructive lung disease is an increasing global health problem of pandemic proportions,~     with COPD alone affecting >10% of the population. Smoking is the main and most well studies~     risk factor for developing COPD. However, chronic airway obstruction also in never-smoking~     populations has recently been recognized as an increasing health problem.~      In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national~     SCAPIS study will be clinically well characterized in one of the six Swedish University~     Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders~     Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all~     never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the~     groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers~     with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the~     Bronchoscopy segment, were sampling will be performed from a number of anatomical locations,~     including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage.~     Serum, plasma, and urine samples will also be collected.~      In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the~     epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from~     multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and~     bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific~     mediators and molecular pathways critical in the pathological mechanisms of obstructive lung~     disease related to never-smoker disease phenotypes will be identified.~      In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of~     relevance for disease pathology will be investigated in bronchial biopsies collected from~     the 300 subjects in the Bronchoscopy segment.~   "
610|NCT03049189|"~     The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide~     Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus~     in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+),~     neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).~   "
611|NCT03049176|"~     This is a prospective, non-randomized, open-label study to look at the uptake, adherence to,~     and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing,~     and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception~     in Zimbabwe.~   "
612|NCT03049163|"~     Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar~     anesthesia. However, both methods have potential complications that can vary from minor to~     severe.~      Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other~     vitreoretinal surgeries.~      Hence, the investigators compared the effect of topical anesthesia (with eye drops) and~     retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.~   "
613|NCT03049150|"~     To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection~     within urine to predict postoperative (after an operation) kidney damage in adults who have~     undergone emergency hip fracture surgery?~   "
614|NCT03049137|"~     Using bone ring grafts with simultaneous implant placement after three-dimensional~     augmentation of severely defective bone ridges using computer-guided surgical templates. The~     study compares accuracy effectiveness by mimics software~   "
615|NCT03049124|"~     Currently, there is no clear indication if exercise is safe and if it confers health~     benefits for adults undergoing preoperative neoadjuvant chemoradiation for rectal cancer - a~     population who may have limited exercise tolerance and who may be at an increased risk for~     adverse events associated with exercise. In this prospective single-arm feasibility trial,~     we aim to examine the safety and feasibility of a 12-week exercise intervention for adults~     undergoing preoperative neoadjuvant chemoradiation for rectal cancer to inform the~     development of a large-scale randomized controlled trial that will assess the efficacy of~     exercise administered during preoperative neoadjuvant chemoradiation for rectal cancer.~     Adults diagnosed with rectal cancer and scheduled for preoperative neoadjuvant~     chemoradiation will be recruited over a 12-month period into a supervised exercise~     intervention consisting of aerobic and strength training to be done 3 times per week.~     Feasibility, safety, patient-reported outcomes, and physical tests will be performed~     pre-intervention, post-intervention, and at follow-up (i.e., 6 weeks post-intervention).~     This study will provide data on the feasibility of an exercise intervention and will help~     determine if it is safe to progress with a large-scale randomized controlled trial to test~     the benefits of exercise for adults undergoing preoperative neoadjuvant chemoradiation for~     rectal cancer. It will also provide initial estimates of the parameters for patient-reported~     outcomes, which are required to calculate the sample size for the large-scale randomized~     controlled trial to ensure it is sufficiently powered.~   "
616|NCT03049111|"~     This study is designed to identify Dermatophagoides farinae, or Der f, sensitive asthmatics~     who demonstrate a late phase asthmatic response after Der f inhalation. These subjects may~     be invited to participate in a planned future study investigating novel asthma treatments.~   "
617|NCT03049098|"~     The aim of this observational study is to compare the visual interests between residents in~     high-fidelity simulation practice~   "
618|NCT03049085|"~     Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass~     Grafting. A double-blind, placebo-controlled, randomized trial.~   "
619|NCT03049072|"~     The purpose of the study is the prospective and standardized data collection of patients~     treated with ion therapy at MedAustron.~   "
620|NCT03049059|"~     A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without~     Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma~   "
1229|NCT03041116|"~     This study will investigate whether fosmetpantotenate (RE-024), a phosphopantothenate~     replacement therapy, is safe and effective in treating patients with Pantothenate~     Kinase-Associated Neurodegeneration (PKAN).~   "
622|NCT03049033|"~     Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow~     movements, small movements, difficulty with movement initiation and disruptions in timing.~     Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday~     tasks such as writing, self-care, and fine object manipulation. These activity limitations~     can lead to disability, social isolation, and a reduced quality of life. In a series of~     breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT)~     and found it can address many gross motor impairments and improve gait and balance. The~     underlying idea is that rhythm is the essential component relating music specifically to~     motor behavior. The mechanism of action is called rhythmic entrainment where one system's~     motion or signal frequency entrains the frequency of another system. The effect of NMT on~     fine motor function has not been investigated yet. Music activities are important in the~     lives of many older adults. Notably, the use of music has been associated with increased~     well-being for older adults, as it fosters social connection and mood regulation.~     Furthermore, many musical activities have limited physical demands, making them attainable~     for individuals who are living with mobility impairments or other physical restrictions.~     Based on the literature and the investigators preliminary studies, the investigators propose~     to test the efficacy of Neurologic Music Therapy in comparison to Occupational Therapy (OT)~     as standards of care on adults in the Parkinson's spectrum. The investigators have defined a~     working plan using different musical instruments and growing tempo to specifically improve~     fine motor movements.~   "
623|NCT03049020|"~     Based on a prospective study, to evaluate how pre-operative pelvic floor status - the~     presence of injury to the musculus levator ani - may influence the results of laparoscopic~     sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the~     presence of such injury increases the risk of post-operative prolapse recurrence~   "
624|NCT03049007|"~     The objective of this project is to prepare healthcare services to use the diagnosis of~     prolonged grief disorder (PGD). The project aims to determine the frequency of PDG in a~     population sample of bereaved spouses and their adult children. It will also identify early~     predictors of PGD and common trajectories of natural and prolonged grief. The mapping of~     grief trajectories may turn out to be a potential prognostic tool to identify individuals~     with high versus low risk of developing PGD. Given the project's large, population-based~     sample and prospective design, this research will inform bereavement research and expand our~     knowledge of PGD considerably both nationally and internationally.~   "
625|NCT03048994|"~     Severe sepsis is a common condition with high mortality and morbidity. A previous~     meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of~     mortality and morbidity benefits in critically ill patients. But there is lack of evidence~     to recommend the use of intravenous glutamine supplementation in this population group. A~     randomized controlled trial which is adequately powered will resolve this issue and can be~     included in future international nutrition guidelines for the critically ill. This pilot~     study is done prior to a proposed local multi-center study to investigate the effects of~     glutamine supplementation.~   "
626|NCT03048981|"~     Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has~     been reported to increase bleeding in patients through inhibiting platelet aggregation and~     prolonging of clot formation time. The Swedish Medical Products Agency recommends that~     patients stop taking the naturopathic medicines including fish oil two weeks prior planed~     surgery. The aim of this study is to examine the effects of fish oil given to healthy~     volunteers using point of care coagulation assessment and flow dependent Cellix instrument~     before and after intake of fish oil.~   "
627|NCT03048968|"~     The purpose of this study was to investigate the effects of the new wearable hip assist~     robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of~     Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and brain~     activity in elderly adults and stroke patients.~   "
628|NCT03048955|"~     PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical~     Success of the study group receiving the Superion® IDS is not inferior to the success rate~     observed in the study group treated by direct decompression at 60 months follow-up.~     Secondarily, the trial is intended to establish that Composite Clinical Success of the study~     group receiving the Superion® IDS at 24 months is not inferior to the success rate observed~     at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly,~     the trial is intended to establish that Composite Clinical Success of the population~     receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate~     observed at 24 months in patients treated with direct decompression.~   "
629|NCT03048942|"~     90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of~     chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly~     Paclitaxel to determine the difference in progression free survival between the 2 groups. If~     results at that stage suggest a potential benefit then the trial will be developed further~     to accrue 70 more patients.~   "
630|NCT03048929|"~     The overall goals of this study are to examine the relationship between chronic inflammation~     and threat and reward sensitivity, and to determine the effects of acute inflammation on~     threat sensitivity, in individuals with and without moderate to severe PTSD symptoms. The~     investigators will first conduct an observational study to examine the relationship between~     chronic inflammation and neural and behavioral measures of threat sensitivity. Then, the~     investigators will conduct a randomized, double-blind, placebo-controlled, between-subjects~     study to examine the effects of acute inflammation on neural and behavioral measures of~     threat sensitivity.~   "
631|NCT03048916|"~     Dysphagia after stroke is associated to increased pulmonary complications and mortality. The~     swallowing therapies could decrease the pulmonary complications and improve the quality of~     life after stroke. The swallowing therapies include dietary modifications, thermal~     stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers~     used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing~     therapies. Some authors performed functional magnetic resonance imaging (fMRI) to~     investigate the brain neuroactivity during swallowing with tasks in normal adults and~     unilateral hemispheric stroke patients. The aim of this study is to explore the effect of~     swallowing therapies not only in clinical swallowing function but also brain plasticity of~     acute stroke patients with dysphagia by videofluoroscopy and fMRI.~   "
634|NCT03048877|"~     Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge~     in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and~     lenvatinib which have been approved by food and drug administration (FDA), could not be~     affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor~     and reduces the angiogenesis of tumor efficiently, which had been proven effective in many~     solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor~     receptor (VEGFR). A phase II study aims to assess the efficacy and safety of apatinib in~     RAIR-DTC was enrolled 20 patients, and 10 of them had obtained a shout-term efficacy,the~     study demonstrate the peculiar potential in treatment of RAIR-DTC. In this study, the~     investigators aim to further explore the efficacy and safety of apatinib in RAIR-DTC.~   "
635|NCT03048864|"~     The purpose of this study is to determine if kidney stone patients who should have received~     metabolic tests (urine collection over 24-hours that determines the composition of urine)~     based on Canadian Urologic Association (CUA) guidelines did in fact receive them, and if~     these results were explained to them by their doctor.~   "
636|NCT03048851|"~     Immediate and maintaining Efficacy of new protocols in the treatment of upper limb~     dysfunctions in patients with cerebral palsy.~   "
637|NCT03048838|"~     Epidemiological studies have attributed the source of many new HIV and STI infections among~     MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious~     interventions for Latino male couples have yet to be tested. The proposed study builds on~     the PI's post-doctoral research in which he adapted evidence based intervention for Black~     MSM couples, Connect `n Unite, for Latino male couples using methodologically rigorous~     adaptation procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands~     the prevention alternatives offered in previous interventions by incorporating biomedical~     prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care,~     adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV~     testing if appropriate given the couple's serostatus. The investigators will conduct a~     randomized control trial (RCT) to examine whether participants assigned to CLP report an~     increase in the proportion of HIV protected anal sex acts (operationalized as using condoms,~     PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention~     control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA~     and randomly assign them to CLP or WP. Participants will complete ACASIs to assess~     behavioral and psychosocial factors and be tested for sexually transmitted infections (STI)~     at baseline, 3 and 6 month post intervention. The investigators will conduct optional~     HIV/STI testing at baseline, 3, and 6 month post intervention. The primary study activities~     will be conducted at a large Latino serving CBO in North Philadelphia. To our knowledge,~     this study will be the first to examine the impact of a couple-based intervention to~     increase HIV protected anal sex acts for Latino male couples capable of being scaled up and~     replicated in various communities to provide continuous support and protection for this~     heavily impacted group.~   "
638|NCT03048825|"~     The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to~     treat ST elevation myocardial infarction. These treatments address both the culprit artery~     (PCI with SYNERGY Stent) as well as the non-culprit arteries (randomization to routine~     colchicine and spironolactone).~   "
639|NCT03048812|"~     Dental implants are often the preferred treatment option and in some clinical scenarios they~     are considered the standard of care to restore missing or damaged teeth, due to the~     limitations of conventional treatments. For fully edentulous subjects, conventional~     tissue-supported dentures in some cases are associated with severe subjective complaints and~     difficult adaptation, mainly the mandibular denture, resulting in limited function and~     detrimental effects on oral health-related quality of life, especially for older patients.~     The use of implants to retain a mandibular denture (overdenture) has been recommended as a~     suitable and low-cost alternative to improve denture stability, with positive effects on~     oral comfort and function. The two-implant mandibular overdenture has been considered an~     effective design to achieve clinical benefits for patients. However, the main problem facing~     two-implant overdenture is the high cost of implantation and the relative complexity of the~     surgical intervention, so the use of a single midline implant to retain a mandibular~     overdenture was suggested as a more viable solution for reducing costs and complexity of~     treatment with similar benefits compared to solutions with higher number of implants.~     Nevertheless, there are few studies that compared the performance of different retention~     systems and their effects on patient-centered outcomes, such as satisfaction with the~     dentures, oral health-related quality of life, individual preferences and other subjective~     ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a~     crossover design is to investigate the changes in clinical and patient-reported outcomes~     following the use of different retention systems for a single implant-retained mandibular~     overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a~     single-implant mandibular overdenture is dependent on the type of retention system, and~     patients have distinct preferences in relation to different attachments~   "
640|NCT03048799|"~     Post-prostatectomy urinary incontinence (IUPP) is a difficult to treat complication that~     causes a profound negative impact on the individual's quality of life, as well as seriously~     disrupts the physician-patient relationship and is a substantial public health problem .~     Urinary incontinence (UI) can occur both in the treatment of benign prostatic hyperplasia~     (BPH) and in the treatment of prostate cancer.~      In the treatment of benign disease, this complication is associated with a very low~     prevalence, initially of 9% and about 1% in 12 months postoperatively. In radical~     prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the~     populations and sites studied, the definitions used, the different methodologies employed in~     the evaluation of incontinence, and also the different degrees of intensity of the disease .~     Several authors have evaluated the incidence of incontinence after robotic radical~     prostatectomy, open and laparoscopically. With these techniques, the reported total UI~     incidence varies from 4% to 40% .~      With the high prevalence of IUPP, accelerating the recovery of urinary control is an~     important priority for patients and their caregivers, and the search for effective and~     low-risk treatments is a constant. Thus, the possibility of treatment with the~     radiofrequency (RF) feature arises.~   "
641|NCT03048786|"~     Despite the availability of a variety of effective treatments for smoking cessation, uptake~     of treatments is low. The increasing use of smartphone technology presents an exceptional~     opportunity to expand access to low-cost smoking cessation services. In this pilot study,~     the investigators will use a text-messaging platform to test peer mentoring for smoking~     cessation, delivered by former smokers. While peer mentoring is a common approach to health~     behavior change, it has rarely been used to maximum effect by smoking cessation programs.~     The text-messaging platform serves as the basis for a randomized controlled trial to test~     the effectiveness of peer mentoring for smoking cessation.~      This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned~     to a peer mentor or not. Participants in the control group will receive automated text~     messages used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National~     Cancer Institute (NCI) in which users receive one to five automated messages per day for up~     to eight weeks. Smokers in the intervention group will receive a modified version of the~     same automated messages from SmokefreeTXT, but with additional personalized messages from an~     assigned peer mentor. Mentors will provide responses to specific questions or comments a~     smoker may have after receiving the automated messages.~      The intervention will last 8 weeks. The study includes primary outcomes to measure the~     acceptability, engagement, user experience, and early efficacy of the intervention.~   "
1230|NCT03041103|"~     Acceptability and tolerance of a new food product in adults and children.~   "
642|NCT03048773|"~     Knee osteoarthritis is a common disease that causes joint pain, stiffness, and movement~     limitation. Nearly 50% in those 75 years and above are affected. In Taiwan, the reported~     prevalence was more than 6000 per year. The cause of pain is joint instability and structure~     changed, including hyaline articular cartilage lost, bony remodeling, capsular stretching~     and periartcular muscle weakness. Current guidelines for treatment of symptomatic knee~     osteoarthritis include exercise, anti-inflammatory drugs, transcutaneous electrical~     stimulation(TENS) and magnetic fields(MF) which reduce pain and improve the patient's~     quality of life.~      However, conservative therapies and oral supplements have been evaluated but are without~     clear efficacy. Prolotherapy is an injection therapy for chronic musculoskeletal pain. One~     of the hypotheses is stimulating local healing and current study demonstrated clinical~     benefit for pain and improvement of function. The effects of multi-point injections were~     more pronounced in several studies than single-point injection.~      Extracorporeal shock wave is common treatment for kidney stones, has been widely used in~     soft tissue diseases, such as calcified tendon lesions and plantar fasciitis. The theory of~     extracorporeal shock wave is energy of high-frequency vibration caused destruction of stones~     and other hard material and by increasing the rate of vascular regeneration in the injured~     area and increasing the rate of autologous tissue repair, possible biological processes~     include increased mesenchymal stem cell proliferation and differentiation, slowing the~     inflammatory response and antimicrobial efficacy. Current studies have shown equivalent~     clinical outcomes on calcific rotator cuff tendinopathy among extracorporeal shock wave~     therapy, sono-guided acupuncture and arthroscopic surgery and the extracorporeal shock wave~     has the advantage of non-invasive treatment.~      Taking the advantages of non-invasive treatment of extracorporeal shockwave. We want to~     design a randomized control trial by multi-point shockwave therapy and physical therapy~     compared with placebo shockwave therapy and physical therapy. Two randomized controlled~     trial (RCT) reported improvement in outcomes in response to shockwave therapy but were not~     methodologically rigorous. The investigators therefore conducted a two-arm RCT to assess the~     hypothesis that adults with symptomatic knee pain receiving shockwave therapy will report~     greater improvement in knee-related quality-of-life than sham shockwave therapy.~   "
643|NCT03048760|"~     The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic~     consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the~     end of 2017. The MRL allows MR images of patients to be acquired before, during and~     following radiotherapy (RT). One area where The Christie is taking the lead within the~     consortium is the application of the MRL for lung imaging and treatment, an area where MRI~     has hardly been used.~      MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate~     delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment.~     In addition, MRI can provide real time imaging which can aid in the accurate motion~     characterisation of these volumes. The addition of functional diffusion weighted imaging~     (DWI) has also proven to be useful in the discrimination of malignant from benign lesions;~     for lymph node detection and for the differentiation of tumour from atelectasis.~      Auto-contouring has the potential to speed workflows at various points in the clinical~     pathway. This may be inter-patient contour propagation used pre-treatment for plan creation,~     or may be during online or offline adaptive workflows propagating contours through imaging~     acquired as treatment progresses. In collaboration with industry the investigators will be~     testing such algorithms on these images retrospectively.~      In addition, the investigators would also like to evaluate patients' experiences of CT and~     MRI scans and determine which scanning method is preferred. Other studies have explored~     patient experiences of MRI compared to CT but not in the lung cancer patient population.~   "
644|NCT03048747|"~     The objective of this study is to investigate the efficacy and safety of tolvaptan based on~     the change in serum sodium concentration following administration of tolvaptan oral tablets~     at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.~   "
645|NCT03048734|"~     This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's~     current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the~     results show that uncontrolled systolic hypertension is independent determinantal of~     nocturia in African American men.~      We now went to pursue this correlation by designing a new NIH grant Proposal to determine~     whether replacing short acting with long acting drugs and dosing them at bed time rather~     than in the morning will:~      A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better~     sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to~     nocturia in some patients.~   "
646|NCT03048721|"~     Transcriptomics is the study of how RNA is expressed under specific conditions.~     Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient~     responds to a drug and separate out drug responders from non-responders. However, biopsies~     are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such~     as tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our~     capabilities to monitor patients on treatment and potentially help us predict if the drug~     will be effective sooner. However, it is not known how well tape-harvesting can capture~     transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to~     address how well tape-harvesting captures the transcriptomic changes that are occurring in~     psoriatic skin.~   "
647|NCT03048708|"~     This study is expected to provide novel data regarding potential structural and functional~     changes of the thyroid gland in morbidly obese adults following significant weight loss~     through bariatric surgery. These data will complement evidence from epidemiological studies~     regarding the association of obesity and alterations in thyroid function. Potentially this~     study may justify further longer-term studies regarding the effects of weight gain and/or~     weight loss on the morphology of the thyroid gland and could help to form recommendations~     regarding follow-up investigations for the thyroid in morbidly obese patients.~   "
675|NCT03048344|"~     Part 1 will be conducted as an open-label, non-randomized, non-placebo-controlled dose~     escalation study using pre-specified doses. Subjects with the following advanced~     hematological disorders and no available therapies, and who satisfy all inclusion/exclusion~     criteria will be enrolled.~      Part 2 will consist of an initial randomized, open-label, 3-sequence, 3-period, crossover~     study to evaluate the bioavailability of a single dose of oral ORH-2014 administered in the~     fed or fasted state (at the MTD or recommended dose identified in Part 1) compared to a~     single dose of IV Trisenox administered at a dose of 0.15 mg/kg.~      Part 3 will be an expansion phase conducted as a single-arm, open-label study to further~     evaluate the safety and tolerability of ORH-2014 at the MTD or recommended dose. Subjects~     with the same disease types as in Part 1 will be enrolled. All subjects will receive oral~     ORH-2014 at the MTD or recommended dose for an initial period of up to 12 weeks.~   "
687|NCT03048188|"~     Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn~     wounds aim at reducing infection and improving reepithelialization. The aim of this study is~     to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey~     dressings with second-degree burn wounds and split-skin grafted burn wounds.~   "
648|NCT03048695|"~     About 85% of patients with schizophrenia have cognitive impairments, executive functions~     being particularly affected. Executive dysfunction, and cognitive deficits in general, are~     important predictors of functional outcomes, including social problem solving, activities of~     daily living, life satisfaction, and the ability to return to work or school.The main~     objective of the current study is to examine the efficacy of group-based Goal Management~     Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk~     individuals with executive deficits. The short term goals are to investigate whether GMT can~     improve participants' ability to organize and achieve goals in everyday life in addition to~     improving aspects of emotional health. A long-term goal would be to establish an evidence~     base for nonpharmacological interventions for patients with broad schizophrenia spectrum~     disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT~     delivered to patients with broad schizophrenia spectrum disorders or high risk for~     schizophrenia result in improved executive functioning, measured by self-reported and/or~     objective measures of executive functions? (2) Does GMT result in improved goal attainment~     in everyday life, social- and real world functioning? (3) Does GMT have a positive impact on~     the patients' emotional health? (4) Are there specific characteristics in patients with~     broad schizophrenia spectrum disorders or high risk for schizophrenia that are associated~     with better treatment benefit from GMT?~   "
649|NCT03048682|"~     This study is a randomized controlled trial designed to assess the rate of failure of~     voiding trials in the early and late post-operative period within patients who underwent~     outpatient pelvic floor surgery that failed initial same day voiding trials. Based on the~     Hakvoort et al. study this study would require 90 subjects. This study would be powered to~     detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out~     rate, 100 total subjects should be enrolled in the study.~      All patients that meet the appropriate inclusion criteria and are scheduled for outpatient~     pelvic floor surgery will be considered for the study. Patients will be counseled about the~     study either in the office during a surgical planning office visit, over a pre-operative~     telephone call, or in the pre-operative area just prior to surgery. Consents will be signed~     in the pre-operative area.~      After surgery, the patient will be given a standardized voiding trial as per the usual~     protocol. If the patient is un-successful in emptying her bladder she will be discharged~     home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the~     patient will be re-assessed for meeting eligibility requirements and will be called and~     randomized to either the early voiding trial group (EVT) or the late voiding trial group~     (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas~     those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are~     unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for~     another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley~     catheter replaced and will return for another office VT after waiting an additional 5-7 days~     or will be started on clean intermittent self-catheterization.~      Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will~     be tested via in-office urinalysis at each office visit, including pre-operatively, and will~     be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine~     cultures that grow out a single organism >10,000 CFU will be treated with appropriate~     antibiotics. In addition, patients will complete quality of life questionnaires at the time~     of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.~   "
650|NCT03048669|"~     Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children~     continue to be infected with HIV perinatally because of sub-optimal adherence to the~     continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal~     eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to~     be implemented to improve adherence to the HIV continuum. The aim of this open label,~     parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous~     Quality Improvement (CQI) interventions implemented at facility and health district level to~     improve retention in care and virological suppression through 24 months postpartum among~     pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic~     Republic of Congo. Prior to randomization, the current monitoring and evaluation system will~     be strengthen to enable collection of high quality individual patient-level data necessary~     for the timely production of indicators and monitoring of program outcomes to inform CQI~     interventions. Following randomization, in health districts randomized to CQI, quality~     improvement (QI) teams will be established at the district level and at MCH clinics level.~     For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in~     the care delivery system using data from the monitoring system, develop an action plan to~     address those bottlenecks, and implement the action plan at the level of their district or~     clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC~     and other resource-limited settings to accelerate progress towards the goal of an AIDS free~     generation.~   "
651|NCT03048656|"~     The structural leg-length inequality caused by the shortening of a segment of an extremity,~     results in an altered position of lower limb joints, the pelvis and the spine in static as~     well as dynamic conditions. That may induce a disturbance of the postural control.~      The objective of this study is to investigate the effect of the structural LLD on the~     control of the posture.~   "
652|NCT03048643|"~     Hospitalizations for severe infections associated with opioid use disorder (OUD), such as~     infective endocarditis (IE), have doubled in the US over the past decade and are frequently~     prolonged and resource-intensive. Once medically stabilized, persons with IE but without~     drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons~     with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more)~     largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD~     infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine~     or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug~     use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT~     (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional~     outpatient care program supporting MAT, may support provision of outpatient IV antibiotic~     therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to~     evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE~     due to opioid use disorder in the hospital for the full duration of antibiotic treatment)~     compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically~     stable).~   "
653|NCT03048630|"~     In this intervention study, the investigators engage Vietnamese American nail salon owners~     to train workers within their salons on how to reduce workplace chemical exposures. The~     long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote~     worker health and safety in this vulnerable worker population.~   "
654|NCT03048617|"~     This is an observational study of patients with Primary Mitochondrial Disease with either~     signs or symptoms suggestive of myopathy. The Investigator will identify potential patients~     through existing medical records and one on-site visit.~   "
710|NCT03047889|"~     To study the epidemiological trends and characteristics for advanced breast cancer patients,~     to analyze these trends and report the results~   "
659|NCT03048552|"~     Developed from adapting and combining two evidence-based programs, Project CONNECT (a~     linkage-to-services program that targets barriers within the probation and substance abuse~     treatment systems) and TIES (a program that teaches family engagement skills to providers),~     Family CONNECT is a linkage-to-services program that targets both family and system-level~     factors to increase youth use of and retention in substance use services. Using Linkage~     Specialists embedded within probation departments, Family CONNECT will be implemented in two~     NYS probation departments. This proposed study will evaluate the impact of Family CONNECT on~     (1) youth referral from probation to substance abuse treatment, (2) youth and family~     engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse~     treatment, and (4) youth substance use and recidivism. This study will also identify family~     and probation organizational factors influencing Family CONNECT implementation in probation~     settings. 50 (+2 pre-pilot) caregiver-youth dyads and up to 36 probation officers will be~     recruited as participants in the study. Caregiver-youth dyads will be evaluated at baseline,~     2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at~     baseline, 6, 12, and 18 months. Counts of youth referred, youth who start treatment, and~     youth retained in treatment will be obtained from the juvenile justice agency at~     pre-implementation, baseline, 2 and 6 months, counts of youth recidivism will be obtained at~     2 and 6 months.~   "
660|NCT03048539|"~     The purpose of this study is to determine the quality of life of transoral endoscopic~     thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will~     be assessed, also.~   "
661|NCT03048526|"~     Patients with mild to moderate dry eye disease will be randomized to receive either~     NovaTears® or Hydrabak® eye drops as control.~   "
662|NCT03048513|"~     Melioidosis in head and neck was observed including clinical presentation, diagnosis with~     titer, and result of treatment.~   "
663|NCT03048500|"~     The purpose of this study is to find the benefits of combining nivolumab with metformin in~     advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We~     will also be looking at the safety of the combination. Nivolumab is currently approved in~     certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by~     the US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is~     being used to treat cancer. This use is not approved by the FDA; therefore, in this study,~     it is considered experimental. Experimental means the U.S. FDA has not approved the drug for~     use in your type of cancer. Nivolumab is an antibody (a human protein that sticks to a part~     of the tumor and/or immune cells) designed to allow the body's immune system to work against~     tumor cells. It is believed that metformin has immune modifying properties, meaning it can~     boost your immune system. As a result, it may help certain cancer treatments, known as~     immunotherapy, to work better.~   "
664|NCT03048487|"~     A retrospective study of protein intake and needs as well as outcomes in critically ill~     adult patients. Data will be collected for up to 7 days of ICU stay.~   "
665|NCT03048474|"~     This is a prospective, monocenter, single arm, phase II trial in 33 patients with~     unresectable MPM, who experience disease progression or recurrence after at least one~     previous line of platinum-based systemic treatment.~      Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be~     given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior~     to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The~     patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21~     thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 1 year~     or until disease progression or unacceptable toxicity occurs.~   "
666|NCT03048461|"~     The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP)~     in the treatment of androgenetic alopecia.~      This is a randomized clinical trial to evaluate the effect of autologous platelet rich~     plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be~     randomized into the study. The study is designed as an 18-month study consisting of 2~     phases. This study was a pilot study designed to determine feasibility of this procedure.~   "
667|NCT03048448|"~     This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of~     QAW039 in patients with hepatic impairment compared to healthy matched control subjects.~   "
668|NCT03048435|"~     Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care~     for patients with locally advanced cervical cancer. Although curative, this treatment is~     challenging and leaves a significant proportion of women with severe toxicity, negatively~     impacting their quality of life. Although most recover over time, a proportion of women do~     not. Therefore, evaluation of quality of life becomes increasingly more important as cancer~     specific outcomes improve. One such method is through patient-reported outcomes (PROs),~     defined as any report coming directly from the patient about a health condition and its~     treatment. This prospective multi-institutional study, involving the Princess Margaret~     (PM), Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH),~     will assess to feasibility and acceptability of integrating a cervical cancer specific PRO~     measurement tool into clinical practice. Cervical cancer patients coming for follow-up~     appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer~     specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed~     by participating patients and health care providers to obtain their perspectives regarding~     the feasibility and acceptability of incorporating the instrument into clinical practice.~     Future directions include designing an electronic platform and expanding its use in cervical~     cancer clinics provincially and nationally. The data collected should help identify~     disease-related symptoms, treatment-related toxicities, facilitate patient-physician~     communication, shared treatment planning and target intervention strategies.~   "
669|NCT03048422|"~     The purpose of this study is to compare the virologic efficacy and safety of three~     antiretroviral (ARV) regimens in HIV-1-infected pregnant women and to compare the safety of~     these regimens for their infants.~   "
670|NCT03048409|"~     A retrospective chart review to assess feeding tolerance in adults who had been switched~     from an intact protein formula to a peptide-based formula due to feeding intolerance in a~     complex continuing care facility.~   "
671|NCT03048396|"~     Transplantation of an uterus~   "
3532|NCT03011008|"~     The purpose of this study is to investigate the therapeutic effect of Liraglutide on~     autoimmune diabetes.~   "
676|NCT03048331|"~     FES is a common and established method in the rehabilitation of persons with spinal cord~     injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding~     disuse and denervation atrophy, improving muscle force, power output and endurance changing~     muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass,~     activation of nerve sprouting, reducing spasticity and motor learning.~      Most of the studies investigated the impact of FES in the lower limbs. For the upper~     extremities fewer studies exist. However, it is supposed that the effects of FES are~     similar.~      In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the~     upper extremities triggered by electromyography (EMG) is an established method to generally~     improve hand and arm function. However, none of those studies has investigated the effect of~     FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is~     supposed to improve the functional outcome in participation. Additionally, FES could~     increase the motor learning process. Supported by the clinical observation we hypothesize~     that FES has a positive influence on the outcome of surgical reconstruction of tendon and/or~     nerve transfers.~   "
677|NCT03048318|"~     Arterial flushing is a standard recommendation in deceased donor liver transplantation but~     not in living donor liver transplantation due to the risk of arterial intimal injury and~     short cold ischaemia time. There is recent evidence on benefit of retrograde arterial~     perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis.~     However there is no data on antegrade arterial flushing.~   "
678|NCT03048305|"~     The investigators collect nasopharyngeal epithelium samples from healthy individuals and~     analyze for biomarkers compared with tumor tissues from another clinical research project.~     The goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal~     carcinoma.~   "
679|NCT03048292|"~     Endovascular treatment has recently become the recommended therapy for acute stroke after~     the publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4,~     REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated~     stroke care guidelines, and many hospitals are not appropriately equipped for~     neurointerventional procedures. Decreased time to treatment is associated with favorable~     clinical outcomes, and best practices to optimize workflow between comprehensive stroke~     centers and secondary hospitals have become an important area of study. This prospective~     study is being conducted on acute stroke cases within the Mount Sinai Health System from 1~     June 2016 up until 31 December 2018. The researchers would like to evaluate how variable~     methods of interventional service delivery for acute stroke affect clinical measures and~     outcomes.~      More specifically, the researchers are conducting this study in order to determine whether~     outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting~     to and receiving treatment at a comprehensive stroke center, will be superior to that~     delivered by a mobilized intervention team at a central satellite hospital. In particular,~     the hypothesis is that factors affecting outcome include presentation to secondary hospital,~     delays with transfer including traffic conditions and time of day, and the acquisition of~     complex imaging within secondary hospitals.~   "
680|NCT03048279|"~     Objectives:~      To contribute new and prospective data to our existing database library for patients with~     MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.~   "
681|NCT03048266|"~     Objectives:~      The aim of the present study is to assess the significance of metabolomics and genetics in~     diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients.~      Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent~     development of aggressive PNET and evaluate patients survival in a nested case-control study~     of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have~     developed non-aggressive PNETs (controls).~      Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have~     developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using~     a targeted metabolomics approach.~      Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing~     in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have~     developed non-aggressive PNETs (controls).~      Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who~     have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive~     PNETs, using a targeted qRT-PCR approach (in serums), as well as to see the relationship of~     potential miRNA biomarkers with patients survival.~   "
682|NCT03048253|"~     Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically~     engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV)~     as the carrier insert GM-CSF gene therapy drug.After gene recombination technology~     successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site~     of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug~     after tumor site local injections of dosing, on the one hand, because of the soluble tumor~     characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the~     injection site specific soluble tumor kill tumor cells;Viral vector expressed in tumor~     site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor~     immune function, play beside the destruction effect, have inhibition effect on the distant~     metastases.~   "
683|NCT03048240|"~     The study pilot evaluate the feasibility of a 5-ALA- PpIX (protoporhyrin IX) mediated~     per-PDT protocol in patients with glioblastoma accessible for complete surgical removal of~     contrast. This treatment will be carried out in addition to the current reference treatment~     of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the~     protocol Stupp~   "
684|NCT03048227|"~     During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM)~     in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will~     participate in two period of 3 months separated by a 3 months washout. During one period,~     they will use CGM to adapt their insulin therapy while during the other period, they will~     manage their diabetes with their usual capillary blood glucose meter. We except to observe~     an increase of time spent in glucose safe range when using CGM.~   "
685|NCT03048214|"~     This study aims to investigate whether infraclavicular nerve block improves acute~     postoperative pain after distal radial fracture surgery.~   "
3533|NCT03010995|"~     The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in~     E-Cigarette users and also study the mechanism involved particularly with vascular~     impairment.~   "
688|NCT03048175|"~     Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry.~     Nevertheless, little is known about the level of general body inflammation of subjects with~     impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal~     of wisdom teeth on the overall health are not known.~      Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by~     bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group~     comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth~     without pathology associated to or history of previous extraction of both wisdom teeth.~      In both groups a medical and dental examination will be performed at the baseline and 3~     months after baseline for the control group or after the second third molar extraction in~     the control group. Blood will be also withdrawn to assess systemic inflammation and other~     systemic parameters.~      Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen,~     oxidative stress and endothelial function analysis.~   "
689|NCT03048162|"~     This study is aimed to assess the effects of intravenously administered three fluid types on~     perfusion index and pulse variability index in patients during preoperative period. Patients~     will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th~     min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion~     index and pulse variability index will be measured and recorded.~   "
690|NCT03048149|"~     This study is retrospective. It focuses on hazelnut allergic patients with a clinical~     history and a positive specific immunoglobulin E (sIgE) against hazelnut and its~     recombinants that have followed a hazelnut oral tolerance induction at the allergy Unit of~     Saint Vincent Hospital of Lille (France) since 2011.~   "
691|NCT03048136|"~     A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent~     Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab~   "
692|NCT03048123|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial~     infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in~     patients with large and unresectable hepatocellular carcinoma staged BCLC A/B.~   "
693|NCT03048110|"~     Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of~     BAY1841788 (ODM-201)~   "
694|NCT03048097|"~     In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based~     on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET~     study will be considered for this study. The study will test the following Aims:~      Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG~     uptake.~      Changes in incubation time can affect imaging target:background ratios and study~     sensitivity/specificity. For the study-directed exam, all patients will undergo sequential~     cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging~     variables will be evaluated as below.~      Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown~     whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients~     will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from~     initial clinical scan.~   "
695|NCT03048084|"~     Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians'~     preference, as there are no studiessupporting the use of one specific anticonvulsant in~     glioma patients. The overall aim of this randomized controlled trial is to directly compare~     the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a~     first seizure.~   "
696|NCT03048071|"~     Congenital heart diseases are nowadays frequently treated in newborns. These congenital~     heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes~     indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a~     Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of~     ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then~     constituted the gold standard in conduit replacement between the right ventricle and the~     pulmonary artery (VD-AP).~      The increasing demand for homografts currently induces a shortage and unmet demands. This~     lack of availability, and the durability of homografts in young patients, has encouraged the~     search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein~     xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for~     RVOT reconstruction. This duct naturally has a central valve with three valvules, and there~     is on both sides of the valve a generous duct length allowing unique adaptation options.~     This conduit, however, is not perfect.~      Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this~     study is to compare operative morbidity and mortality when replacing Contegra® or homograft.~   "
697|NCT03048058|"~     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema~     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All~     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to~     apply it once daily per package insert. Adherence will be assessed using weekly internet~     surveys to document how often the medication is being used, as well as reminders about~     rosacea triggers and general use of brimonidine.~   "
698|NCT03048045|"~     Patients who had had systematic periodontal treatment (antiinfective treatment with~     subgingival debridement under local anaesthesia and if required periodontal surgery) at the~     Dept. of Periodontology starting from October 2004 are re-examined 10 years +/- 12 months~     after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of~     supportive periodontal treatment) until 100 patients have been enroled. Radiographs~     (periapicals or panoramics) from start of treatment should be available.~   "
719|NCT03047772|"~     The benefit of current stem cell transplantation therapy for myocardial infarction is~     limited by low survival rate for stem cell. The purpose of this study is to test whether~     intensive Atorvastatin therapy can improve the outcome of patients with impaired left~     ventricle function after acute myocardial infarction who underwent intracoronary transfer of~     autologous bone marrow mesenchymal stem cells.~   "
720|NCT03047759|"~     Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.~   "
721|NCT03047746|"~     This is a single arm pilot study using TCR alpha/beta+ T cell-depleted peripheral blood stem~     cells (PBSC) from closely matched unrelated donors or partially matched/haploidentical~     related donors for hematopoietic stem cell transplant (HSCT) in patients with acquired and~     inherited bone marrow failure (BMF) syndromes.~   "
699|NCT03048032|"~     LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective~     observational cohort multicenter clinical study. Project is carried out by Vilnius~     University together with a partner Lithuanian University of Health Sciences, in conjunction~     with a research protocol of international GREAT consortium (Global Research on Acute~     Conditions Team). The aim of this project is to find the specific novel biomarkers of acute~     heart failure (AHF), to evaluate their diagnostic and prognostic role in association with~     echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and~     rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2)~     post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1~     and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular~     mortality and rehospitalization.~      During the project a sizeable national database (2000 Lithuanian patients) will be~     integrated into database of GREAT network. Novel cardiac biomarkers together with ultrasound~     parameters of right ventricular (RV) function are in the focus of the study. During the~     acute phase of heart failure, up to 15 novel cardiac, vascular, renal impairment and~     inflammation biomarkers in plasma samples will be investigated in Lithuania and France~     (INSERM laboratory). Plasma samples will be taken during 4 hours after admission and frozen~     at -80ºC to allow batch analysis. The extensive evaluation of innovative ultrasound~     parameters of right ventricular structure and function will be performed in the early~     hospitalization period, along with standard echocardiography examination. The first database~     of AHF patients in Lithuania will provide demographic data and trends of morbidity and~     mortality, as well as analysis of diagnostic and prognostic value of novel biomarkers and~     echocardiography parameters in the Baltic region. Quantitative parameters of RV systolic~     function and deformation will be measured. It is expected that optimal use of novel~     biomarkers and reproducible echocardiography parameters in the setting of emergency and~     critical care would reduce unnecessary hospitalizations, cost and hospital length of stay~     without decrease in the quality of diagnostics and treatment. An estimation of correlation~     of echocardiographic parameters and biomarkers could help create an accurate algorithm for~     risk stratification and diagnosis of AHF in an emergency setting.~   "
700|NCT03048019|"~     Immediate potent inhibition of platelet function is critical for the prevention of~     periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial~     infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI).~     Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with~     loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition~     of platelet aggregation is not possible even with the newer oral agents, prasugrel and~     ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor~     (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will~     provide more desired antiplatelet effects in the setting of PCI. This study will measure and~     compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with~     N-STEMI and undergoing PCI.~   "
701|NCT03048006|"~     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic~     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The~     aim of this study, which was conducted in accordance with section 67, paragraph 6 of the~     German drug regulation, Arzneimittelgesetz, was to gain additional insights into the~     diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most~     up-to-date MRI techniques and application methods.~   "
702|NCT03047993|"~     The goal of this clinical research study is to learn if CB-839 given in combination with~     azacitidine can help to control the disease in patients with myelodysplastic syndrome (MDS).~     The safety of this drug combination will also be studied.~   "
703|NCT03047980|"~     The purpose of this research study is to gain a preliminary understanding of the safety of~     sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess~     the utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber~     syndrome.~   "
704|NCT03047967|"~     Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on~     smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although~     environnemental tobacco smoke exposure effects are well known, consequences of prenatal~     tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our~     group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal~     epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings~     support the hypothesis that α7-nAChR are involved in the process of deleterious effects of~     tobacco smoking on respiratory epithelium development. The purpose of the present clinical~     study is to compare PTSE neonates with controls according to lung function and respiratory~     epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will~     be obtained from gentle nasal brushing performed under antalgic premedication according to~     the method we previously published. Epithelium samples will be used for in vitro studies of~     α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing~     will be performed, by means of baby-body plethysmography.~   "
705|NCT03047954|"~     The objective of this pilot double-blind study was to evaluate the efficacy and the safety~     of Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the~     evolution of the disease in children suffering from Atopic Dermatitis (AD).~   "
706|NCT03047941|"~     The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA,~     STOP-Bang, P-SAP, and OSA50.~      The aim of this study is to evaluate the optimal cutoff value of these four scores to detect~     specifically serve OSA patients with hypoxemia.~   "
707|NCT03047928|"~     Combination therapy is becoming more and more general in the treatment of oncological~     diseases. In this clinical trial combination the standard immunotherapeutic treatment; the~     programmed death 1 (PD-1) regulatory antibody Nivolumab and a peptide vaccine consisting of~     programmed death ligand 1 (PD-L1) and Indoleamine 2,3-dioxygenase (IDO) peptides will be~     tested in patients with metastatic melanoma. Patients will be treated with Nivolumab every~     second week as long as there is clinical benefit. The PD-L1/IDO peptide vaccine is given~     from start of Nivolumab and every second week for the first 6 vaccines and thereafter every~     fourth week up to 1 year.~   "
708|NCT03047915|"~     This will be a randomized controlled study evaluating the effect of a music-listening~     intervention compared to standard care (control) during patient visit to the emergency~     department (ED). Randomization will be done with consecutive sealed envelopes.~      Data collection will be prospective with administration of the State Trait Anxiety Inventory~     and collection of physiologic parameters (pain level, heart rate, blood pressure).~     Retrospective data will also be collected for covariate analysis (age, race/ethnicity,~     emergency severity index (ESI), pain medications administered during the ED visit, pain~     scores throughout ED visit, chief complaint, and ED discharge diagnosis).~   "
709|NCT03047902|"~     This is an exploratory randomised matched cohort pilot study. It is hypothesised that~     adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma~     clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without~     a parent present and if advised that they will have biological validation of their smoking~     status using a carbon monoxide monitor. It is a study of 30 subjects, who will be recruited~     over a period of 6 months.~   "
711|NCT03047876|"~     Many neonates and infants who undergo complex cardiac surgery are affected by neurological~     developmental delays. Whilst catastrophic events are immediately identifiable from clinical~     examination or by macro changes on MRI or CT scans, smaller changes are often not~     immediately visible or detected.~      This is an observational pilot study examining brain vascular reaction to hypothermic~     circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during~     aortic arch surgery in neonates and infants. A combination of duplex ultrasound and~     transcranial doppler will be used to record in-depth information on the cerebrovascular~     changes that occur during the entire length of the surgical procedure and during the early~     postoperative period. The proposed techniques and equipment are non-invasive and are in use~     clinically to evaluate brain perfusion in a similar age group.~      During aortic arch surgery, the patient's body and brain temperature is reduced to values~     between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a~     form of metabolic protection. However, there is no consensus within the clinical community~     regarding the optimal temperature at which to perform surgery. Moreover, in order to improve~     cerebral perfusion, the brain is perfused via the right internal carotid artery with cold~     blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but,~     due to clinical preference, differs in relation to the temperature at which surgery is~     undertaken. This provides the opportunity to observe the impact of different temperatures on~     cerebral vascular reactivity in neonates and young infants The arguments for future~     comparisons and a larger randomised study will be made based on the information gained from~     this observational study.~   "
712|NCT03047863|"~     The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for~     dermatologic adverse events related to EGFR inhibitors.~   "
713|NCT03047850|"~     Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This~     study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and~     Delta Down.~   "
714|NCT03047837|"~     Epidemiological studies and cardiovascular prevention trials have shown that low-dose~     aspirin (ASA) can inhibit colorectal cancer (CRC) incidence and mortality, including~     inhibition of distant metastases. Metformin (MET) has also been associated with decreased~     CRC incidence and mortality in meta-analyses of epidemiological studies in diabetics and has~     been shown to decrease by 40% colorectal adenoma recurrence in a randomized trial. Recent~     studies have shown that ASA is an inhibitor of mTOR/S6K1 and an activator of AMPK, targeting~     regulators of intracellular energy homeostasis and metabolism, and that the combination of~     ASA and MET, another AMPK activator and S6K1 inhibitor, has a striking additive effect on~     AMPK activation and mTOR inhibition, with increased autophagy and decreased cell growth in~     CRC cell lines. While both drugs are being tested as single agents, their combination has~     not been tested in trials.~      This is a randomized, placebo-controlled, double blind, 2x2 biomarker trial of ASA and MET~     to test the activity of either agent alone and the potential synergism of their combination~     on a set of surrogate biomarkers of colorectal carcinogenesis. After surgery 160 patients~     with stage I-III colon cancer will randomly be assigned in a four-arm trial to either ASA,~     100 mg day, MET 850 mg bid, their combination, or placebo for one year. The primary endpoint~     biomarker is the change, defined as the difference between pre- and post-treatment~     expression of nuclear factor kappa-B (NFκB), in the unaffected mucosa of proximal and distal~     colon obtained by multiple biopsies in two paired colonoscopies one year apart. Additional~     biomarkers will include: 1) the genomic profile of candidate genes, pathways, and overall~     genomic patterns in tissue biopsies by genome wide gene expression arrays; 2) the IHC~     expression of tissue pS6K, p53, beta-catenin, PI3K; 3) the associations of mutations and~     SNPs with treatment response by next generation sequencing of primary tumors; 4) the~     measurement of circulating IL-6, CRP and VEGF and 5) plasma and colonic MET concentrations~     and their correlation with biomarker profiles.~   "
715|NCT03047824|"~     After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion~     Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate~     treatment cohort will then be consecutively enrolled, followed by the tight glycemic control~     cohort.~      After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory~     evaluations will be determined.~      Subjects enrolled in the standard of care cohort will be treated according to the~     institution's protocol for measuring glucose and managing insulin. These subjects will be~     monitored on a GlucoClear System but they will not be managed based on the values or trends~     of the GlucoClear system.~      Subjects enrolled in the treatment cohorts will be monitored and managed with a special~     version of the GlucoClear continuous monitoring system. This system contains the GlucoClear~     Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to~     manage patient glucose within pre-specified target levels. These recommendations are~     presented on screen for a clinical professional to approve or override.~      Subjects in the moderate treatment cohort will have their glucose managed in the range of~     120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in~     the range of 80 - 120 mg/dl.~      After discharge from the ICU, subjects will followed for adverse events and mortality at 30~     days, either by telephone contact or office visit.~   "
716|NCT03047811|"~     The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells~     treatment of advanced solid tumors~        1. The main purpose - security and ORR;~        2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years~          survival rate;The quality of life.~   "
717|NCT03047798|"~     This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo~     salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque.~     Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica~     extracts and the same participants will also use placebo for tooth brushing by cross-over~     design.~   "
718|NCT03047785|"~     Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin~     assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile~     value is the recommended value to use when diagnosing patients with an acute myocardial~     infarction. With the advent of the new highly sensitive troponin assays it has become clear~     that many patients have a troponin level above the 99th percentile when they have not~     suffered a myocardial infarction. We believe part of the problem with interpreting the the~     troponin values for patients is that the 99th percentile value which determines the ULN has~     been derived from population that is very different to the hospital population of patients.~     This study aims to demonstrate what the 99th percentile is for the population of people who~     use the hospital services who are traditionally older and have more comorbidities when~     compared to the population traditionally used to define the 99th percentile of a troponin~     assay.~   "
853|NCT03046017|"~     Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of~     transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream~     as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine~     separate days not requiring an overnight stay in the hospital.~   "
722|NCT03047733|"~     OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the~     conventional continuous excimer laser treatment.~      DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was~     performed in two tertiary health care centers in Korea.~      PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than~     5 years' disease duration were enrolled.~      INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the~     continuous or the cyclic on-off treatment. All lesions were treated twice weekly for~     9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total~     3 cycles). Topical tacrolimus was applied throughout the trial.~      OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with~     clinical photographs. The primary outcome was mean difference of repigmentation rates and~     the non-inferiority margin was set at 10%. During intermission period, the clinical changes~     such as loss of repigmentation or worsening of the vitiligo lesions were assessed.~   "
723|NCT03047720|"~     This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any~     effect on benign nocturnal enuresis.~   "
724|NCT03047707|"~     The purpose of this multi-center prospective study is to evaluate the diagnostic performance~     of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of~     hepatic fibrosis.~   "
725|NCT03047694|"~     Lexical semantic disorders are described in Alzheimer's disease, and their incidence in~     everyday life is important to the extent that these disorders affect expression and~     comprehension.~      Providing a tactile tablet stimulation, independent and complementary to speech therapy,~     could help to maintain certain abilities and reinforce the feeling of autonomy of the~     patients.~   "
726|NCT03047681|"~     An association between mast cells and outcomes of patients undergoing transcatheter aortic~     valve replacement (TAVR) has not been studied to our knowledge. We aim to characterize~     tryptase levels dynamics during TAVR; Demonstrate whether tryptase level post-TAVR can be~     used as a prognostic marker.~   "
727|NCT03047668|"~     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.~     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted~     by pharmacological intervention, although lifestyle modification and dietary treatment would~     be favourable.~      The researchers therefore investigate dietary strategies such as low-carb and very-low~     calory diets regarding their potential to improve metabolism and body weight in (mostly)~     long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published~     elsewhere).~      POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements~     from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.~   "
728|NCT03047655|"~     A growing number of cross-sectional studies is investigated the role of the human lipidome~     as a new biomarker for metabolic diseases. However, data on this issue is still sparse and~     especially interventional data is not available up to now.~      GesundLeben will provide data on 100 human subjects with metabolic syndrome, undergoing~     distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will~     be covered with routine laboratory parameters and oral glucose tolerance test as well as~     non-radiologic anthropometric measurements.~   "
729|NCT03047642|"~     This project aims to evaluate the performance characteristics of rapid tests to~     differentiate bacterial from non-bacterial infection in febrile adults and children~     presenting at OPDs (outpatient departments) i.e.(fever triage assays) in three LMICs. The~     evaluation will include a different commercial biomarker combinations as well as individual~     biomarkers to assess their individual or combined value in the target population. Markers~     will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to~     contribute to a centralized biobank of well-characterized specimens for use by IVD companies~     and academic institutions for the development and evaluation of emerging assays.~   "
730|NCT03047629|"~     This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of an orally-administered medication to relieve symptoms of constipation~     associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be~     studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be~     studied over an 8-10 week period. All subjects will receive the study drug during one of the~     observational periods of the study.~   "
731|NCT03047616|"~     Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with~     clinical trials showing an approximately 20% durable response in unselected patients with~     advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to~     accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly~     discover and evaluate the utility of blood based biomarkers for use in measuring and~     predicting response to immunotherapy in patients with lung cancer.~   "
732|NCT03047603|"~     The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of~     HCC cases were at advanced stage when the diagnosis established.Early diagnosis improves the~     prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by~     Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter~     study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants~     including healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver~     cirrhosis are consecutively recruited into the cohort. All the serum samples are collected~     before any treatments and will be tested in single center in order to decrease bias. Serum~     samples were tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine~     aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl~     transferase(GGT),alpha-l-fucosidase(AFU),etc.~   "
733|NCT03047590|"~     This study will evaluate adherence to four types of walking programs. Participants will be~     randomized to walking programs that included either (1) affect-based exercise intensity, (2)~     self-selected (or choice-based) exercise intensity, (3) heart-rate based exercise~     intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective~     benefits.~   "
874|NCT03045744|"~     The investigators have recently shown in two pilot incomplete SCI patients that long-term~     paired associative stimulation is capable of restoring voluntary control over some paralyzed~     muscles and enhancing motor output in the weak muscles (1). In this study, the investigators~     will administer long-term paired associative stimulation to incomplete SCI patients in a~     long-term manner, keeping each patient in the study for as long as continuous improvement is~     observed.~   "
734|NCT03047577|"~     Patients non-electively admitted to intensive care units (ICUs) will be screened for~     eligibility. The investigators will include adult patients with risk level alcohol use,~     defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained~     from the patient in the end or shortly after the ICU treatment, when they have regained~     sufficient cognitive function. 600 patients will be randomized to receive either routine~     treatment or a brief intervention (BI). The BI includes a 20 minute discussion with~     pre-educated study personnel, option to discussion with a social worker and written~     material. Primary outcome measure is the amount of alcohol used during the preceding week~     (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an~     interview by a study team member blinded for the intervention arm at 6 months 2) A letter of~     a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded.~   "
735|NCT03047564|"~     Metal ion release from metal implants may have side effects. It can be reduced by coating of~     the implant. This study compares coated and uncoated TKA.~   "
736|NCT03047551|"~     The investigator will perform a multicenter, randomized controlled trial in practices that~     routinely use transvaginal sonography (TVS) to compare how often clinicians order additional~     testing prior to medical abortion after the use of either TVS or transabdominal ultrasound~     (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either~     TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care~     from about 30 providers over 6-8 months.~      The primary study outcome will be the proportion of women that requires additional~     evaluation after sonography, prior to determination of medical abortion eligibility. The~     second primary outcome will be patient satisfaction, determined by a patient satisfaction~     questionnaire utilizing a visual analog scale.~   "
737|NCT03047538|"~     The aim of this study is to compare the effect of fixed and free combination of~     atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.~   "
738|NCT03047525|"~     Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and~     Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop~     cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment~     will improve the prognosis of advanced solid tumors.~      Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy~     with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.~      Study treatment:~      Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK~     treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy~     are available in both groups.~   "
739|NCT03047512|"~     Major depression is a highly prevalent and severe mental disease that negatively alters the~     lives of people, their families, and their social environment.~      Organizations that promote mental health policies have recognized the potential of new~     information technologies for the prevention and treatment of mental disorders. In this~     direction, information and communication technologies (ICTs) generate opportunities for~     increasing patient well-being through the use of on-line software. Such programs often~     include interactivity, self-monitoring, information materials (sometimes in multimedia~     format), and exercises on problem solving, recognition and challenging of dysfunctional~     thoughts, scheduling of activities, behavioral experiments, and other psycho-educational~     activities.~      In Colombia, there are few preventive mental health interventions scientifically oriented~     and seeking to demonstrate efficacy in context.~      The purpose of this study is to determine whether an internet-based program is effective to~     prevent and to intervene early the depression in adolescents between 11 and 20 years of age~     in 2 schools in the Antioquia Region, Colombia.~   "
740|NCT03047499|"~     Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of~     complete unilateral cleftlip repair by modified millard cheiloplasty~   "
741|NCT03047486|"~     The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin~     pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which~     allows the continuous measure of interstitial glucose rate. The results are available in~     real time to the user, who can so use them to optimize the adjustment of its treatment by~     insulin pump. Since a few years, several research programs aim for finalizing an automated~     system using the data of real time interstitial glucose to adjust automatically, via an~     algorithm, the release of insulin by the pump. This type of closed-loop system is for the~     moment only experimental, not still widely available in routine. On the other hand,~     rudimentary regulation systems partially automated already exist and can be used in common~     clinical practice. One of these systems, Smartguard ®, allows this type of regulation to~     decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo~     minimizer which interrupts the basal output when the algorithm embarked on the pump~     determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The~     efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric~     and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes~     Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published~     data concerning the method of use of this system (sensor et pump initial configuration;~     patient education), nor the evolution of the sensor and pump parameters during the use.~      The aim of this observationnelle study is to collect the data of efficiency, safety and use~     of the system Smartguard ® in common clinical practice in an adult population of subjects~     DT1.~   "
742|NCT03047473|"~     This is a safety and tolerability study looking at the addition of avelumab, an immune~     checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with~     newly diagnosed glioblastoma multiforme.~      All patients will be receiving active therapy. Patients will begin the avelumab within 3~     weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every~     2 weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total~     of 52 weeks.~   "
743|NCT03047460|"~     The establishment of a biomarker(s) that can predict a clinical response to therapy over the~     course of a 1-2 year clinical trial is critical for the expeditious development of~     treatments for Multiple Sclerosis (MS). Identification of this biomarker would enable~     shorter and smaller clinical trials resulting in the faster development of much needed~     treatments for MS, specifically neuro-reparative therapies. The etiology of disease~     progression is conduction block, demyelination and axonal degeneration. Evoked potentials~     provide a direct assessment of the underlying etiologies of disease progression in MS. They~     are a functional assessment of multiple pathways, including visual, motor and sensory,~     evaluating the integrity of myelin and axons.~      The variability of motor evoked potentials (MEP) measures has limited multimodal evoked~     potential (mmEP) use in international, multicenter clinical trials. MEP evaluation does~     significantly contribute to the predictive value of mmEP's. Recent advances in technology~     and establishment of standardized protocols for MEP reduces the variability associated with~     this procedure. The objective of this study is to evaluate the reliability and feasibility~     of MEP and SSEP in an international, multicenter trial so that mmEP can be further evaluated~     as a biomarker for disease progression. The rationale for this study is to explore the~     feasibility and reliability of MEP's and somatosensory evoked potentials (SSEP's) in a~     multicenter clinical trial for potential use as a biomarker that can predict clinical~     progression/improvement in international clinical trials evaluating remyelinating therapies.~      Study Objectives and Endpoints:~      Objective:~      The primary objective of the study is to evaluate the feasibility and test-retest~     reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and~     subjects with MS.~      Endpoints:~      The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the~     following evoked potential parameters~      Motor Evoked parameters that will be measured:~        -  MEP latency~        -  Central motor conduction time (CMCT) root latency methods~        -  MEP amplitude~        -  MEP amplitude to compound motor amplitude ratio (MEP-M ratio) for the right and left~          abductor digiti minimi (ADM) and the right and left tibialis anterior (TA)~        -  Somatosensory evoked potential parameters will include Evoked potential latencies for~          both upper and lower limbs bilaterally.~      Study Design:~      This multinational, multicenter study will be conducted in healthy adult volunteers and MS~     patients to establish the feasibility and reliability of mmEP's. A total of 40 subjects, 10~     (5 healthy and 5 MS) from each of the 4 sites will be enrolled.~      The study will consist of two visits, 1-30 days apart, during which subjects will be~     screened to confirm eligibility and will complete all specified study assessments.~      Study Locations:~      Canada, Germany, Switzerland and Italy, with 1 site in each country.~      Number of Planned Subjects:~      A minimum of 40 subjects are planned for this study. Subjects who withdraw from the study~     prior to completion of the second visit may be replaced at the discretion of the~     investigator.~      Study Population:~      This study will be conducted in subjects 25 to 58 years of age, inclusive, who are either~     healthy volunteers (HV) or have been diagnosed with clinically definite MS who have a~     detectable lesion by MEP or SSEP.~      Study Groups:~      Two groups, healthy volunteers and clinically definite MS will be included.~      Duration of Study Participation:~      Study duration for each subject will be two visits, the second visit schedule >24 hours-30~     days from the first visit~      Criteria for Evaluation:~      Key Study Assessments:~      Electrophysiological. MEP's and SSEPs will be measured in both upper and lower limbs~     bilaterally. All studies will be read locally and reviewed by a blinded reader at another~     center. The ICC of every measured evoked potential parameter will be determined on both the~     central and local reads.~   "
827|NCT03046368|"~     Several studies indicate that a survey that adapts personalized design features achieves~     higher participation rates. A feature can be a personalized cover letter which appears more~     relevant and interesting for the sample member. In the spirit of adaptive design, this study~     seeks to establish whether it can be advantageous for participation overall to use cover~     letters with targeted content and whether the effect on participation of different versions~     of the cover letter varies in sample subgroups in order to optimize design features in~     future surveys.~   "
744|NCT03047447|"~     Original research article entitled Induced and Controlled Dietary Ketosis as a Regulator of~     Obesity and Metabolic Syndrome by Madeline Gibas for consideration for publication in a~     clinical journal. This research manuscript builds on previous landmark studies that report~     that major weight and fat mass loss in type II (T2D) patients who were fed a very low~     carbohydrate, ketogenic diet. In this manuscript, the investigators outline our research~     study that showed statistically significant (p < 0.05) changes over time in hemoglobin A1c,~     weight, BMI, body fat percentage and ketones for patients with metabolic syndrome who were~     fed a very low carbohydrate diet, ketogenic diet.~   "
745|NCT03047434|"~     2.1Purpose: The purpose of this study is to describe the chronology of postoperative pain in~     patients undergoing shoulder, knee, ankle arthroscopy. Further, within this population the~     predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for~     persistent post surgical pain.~      2.2 Research Design: This is a prospective descriptive correlational design looking to~     characterize postoperative pain variables across various procedures that historically have~     significant levels of persistent post-surgical pain. Further, bivariate correlations at~     different time points will be examined to see how DVPRS along with Pain Assessment Screening~     Tool and Outcomes Registry (PASTOR) correlates with other measures.~      2.3 Methodology/Technical Approach A total goal of 250 participants will be queried~     regarding their postoperative pain experience following shoulder arthroscopy and knee~     arthroscopy. Descriptive multidimensional tools (the DVPRS and the electronic Pain~     Assessment Screening Tool and Outcomes Registry (PASTOR)) will be used preoperative either~     during their preoperative surgical visit or the day of surgery and extending to 6 months~     postoperatively. As these tools have been utilized in previous studies for the prediction of~     persistent post surgical pain, the DVPRS will additionally be evaluated for its predictive~     validity as it is a short, easy-to-administer, bedside tool.~   "
746|NCT03047421|"~     DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).~      One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this~     study is to compare the influence of different methods of neck circumference measurement in~     the accuracy of DES-OSA and P-SAP scores to detect OSA.~   "
747|NCT03047408|"~     About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a~     parasomnia characterized by partial or complete loss of REM sleep muscle atonia and~     dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia~     is the polysomnographic hallmark of RBD, and its quantification is necessary for the~     diagnosis.~      RBD in PD is believed to be a marker of a more widespread degenerative process and a marker~     of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired~     in both motor and non-motor domains, compared to those without RBD, with an increased risk~     of dementia. However, little is know about the relationship between the evolution of RBD,~     clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD~     symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in~     PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal~     vPSG study has been performed in PD-RBD population.~      Thus, the main objective of this study is to longitudinally evaluate clinical and~     video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in~     patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain~     whether RBD features remain stable over time. The possible remission of RBD with the~     progression of PD would question indeed its reliability as prognostic bio-marker.~   "
748|NCT03047395|"~     The purpose of this study is to investigate the long-term safety and efficacy of~     risankizumab in the treatment of moderate to severe chronic plaque psoriasis.~   "
749|NCT03047382|"~     Around a third of patients who develop acute kidney injury (AKI) do so after a hospital~     admission (hospital-acquired - HA-AKI).~      The primary aim of the study is to prospectively test whether introducing a complex~     intervention (a 'care package' - comprising a clinical prediction rule incorporating an~     electronic alert which generates a checklist for patient management to relevant health~     professionals) can identify patients on admission to hospital who are at risk of developing~     HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to~     be put in place.~      The investigators will introduce the care package in one acute hospital and evaluate its~     effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to~     a sister hospital within the same Trust (which will act as a control site). The~     investigators will extend evaluation for a further ten months to assess sustainability on~     the first site and introduce the package at the control hospital to assess generalisability.~     The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes~     associated with HA-AKI, management of patients already with AKI on admission to hospital~     (whose care may also benefit from the checklist) and a cost-effectiveness analysis.~   "
750|NCT03047369|"~     This is an observational designed to:~        -  Aim 1: Define novel homogeneous groups of patients with unclassified leukodystrophy and~          work toward finding the cause of these disorders;~        -  Aim 2: Assess the validity and utility of next-generation sequencing in the diagnosis~          of leukodystrophies;~        -  Aim 3: Establish disease mechanisms in selected known leukodystrophies;~        -  Aim 4: Track current care and natural history of these patients to define the~          longitudinal course and determinants of outcomes in these disorders.~      These objectives will be achieved by collecting, and subsequently analyzing, data and~     samples in a longitudinal fashion across leukodystrophies.~   "
751|NCT03047356|"~     A trial that tests whether implementation intentions improve sleep among adoelescents.~   "
764|NCT03047187|"~     Objectives:~        1. To examine the ability of ACLR patients at discharge from rehabilitation to perform a~          single-hop for distance.~        2. To examine isometric muscle strength of ACLR patients at discharge from rehabilitation.~        3. To examine ACLR patients' self-reported knee function at discharge from rehabilitation~        4. To assess the psychological factors for ACLR patients at discharge from rehabilitation.~        5. To correlate single-hop for distance with self-reported knee function, strength and~          psychological factors for ACLR patients at discharge from rehabilitation to discover~          whether any of these factors can predict the others.~   "
828|NCT03046355|"~     The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can~     improve the baby's health at birth when compared with delivery at a later point in the~     pregnancy.~   "
752|NCT03047343|"~     Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment~     to newborns suffering from congenital heart defects, characterized by an increase in blood~     flow and pulmonary blood pressure.~      The intervention consists of placing a band around the pulmonary artery. This band causes an~     artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It~     acts as a first step, preparing the ground for a future definitive repair intervention.~      It is mainly used in the context of septal defects, atrio-ventricular canal defects or~     uni-ventricular hearts.~      The complications linked to strapping include, among others, the erosion of the band in the~     artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary~     valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping.~      The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and~     13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the~     mortality is linked to the nature of the cardial malformation (uni-ventricular or~     bi-ventricular) rather than the procedure itself.~      This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality~     rate of pulmonary artery strapping, as well as the readjustment rate within two groups of~     patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting~     from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality~     rate of the intervention and the incidence of complications within the hospital, within the~     two groups.~   "
753|NCT03047330|"~     This study aims to investigate the impact of menopause-related sleep fragmentation on~     metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep~     fragmentation will result in an adverse leptin response as a metabolic biomarker for body~     fat gain.~   "
754|NCT03047317|"~     This is an open label study of MABp1 in six healthy volunteers. Participants will receive a~     single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling~     for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr,~     1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In~     addition to pharmacokinetic data, participants will be monitored for the development of~     treatment emergent adverse events.~   "
755|NCT03047304|"~     Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of~     gestation. High concentration of Magnesium in the blood stream known as cause of conduction~     abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our~     work is to evaluate the PR intervals in embryos after maternal treatment with magnesium~     during preterm labor.~   "
756|NCT03047291|"~     Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus~     reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or~     periimplantitis, as a coadjuvant treatment of mechanical therapy.~   "
757|NCT03047278|"~     This study aims to investigate the influence of the glycemic control of type 2 diabetes~     (DM2) and of cetirizine (OCT2 inhibitor) on gabapentin kinetics disposition and~     pharmacokinetics-pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus,~     non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=10) and~     patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in~     pain visual analog scale (0-10) are being investigated.~   "
758|NCT03047265|"~     This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent~     Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally~     Advanced Nasopharyngeal Carcinoma~   "
759|NCT03047252|"~     The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system~     - SWORD Phoenix- in the rehabilitation after total knee replacement .~      SWORD Phoenix allows the patients to perform independent rehabilitation sessions at home,~     under remote monitoring from the clinical team.~      The investigators hypothesize that the clinical outcomes of a home-based rehabilitation~     program will be at least similar to the outcomes of a traditional home-based rehabilitation~     with face-to-face sessions.~      This is a randomized controlled trial with active comparator. Patients will be enrolled and~     randomized pre-operatively into 2 groups: intervention group and control group. Both groups~     will perform 8 weeks of rehabilitation starting on day 7 after surgery.~      The intervention group will perform daily rehabilitation sessions at home using SWORD~     Phoenix, under remote monitoring from a physical therapist. The control group will perform~     1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.~      Outcomes will be measured at weeks 4 and 8. The primary outcome is the performance in the~     Timed-up-and-Go (TUG) test between in each patient in comparison with the pre-operative~     score. Secondary outcomes will be measured in term of: a) range of motion of the knee joint~     (flexion/extension); b) Knee Osteoarthritis Outcome Score); c) quality of life, as measured~     by the SF-36 scale.~   "
760|NCT03047239|"~     Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural~     vision tests measured prospectively every 3 months over a 2-year period, will be used to~     model TF's ability to serve as a risk factor for individual progression rates.~   "
761|NCT03047226|"~     The purpose of this study is to determine the proportion of patients diagnosed with Lynch~     syndrome in colorectal cancer patients with the loss of staining by immunohistochemistry~     (IHC) of any of the mismatch repair (MMR) proteins. Besides, this study aims to test the~     specificity and the sensitivity of detecting microsatellite instability (MSI) by~     next-generation sequencing, and to find out the consistency between IHC and MSI in~     colorectal cancer patients in China. In addition, researchers want to analyze the clinical~     characteristics and germline mutation of Lynch syndrome in Chinese population.~   "
762|NCT03047213|"~     This pilot phase II trial studies how well sapanisertib works in treating patients with~     bladder cancer that has spread from where it started to nearby tissue or lymph nodes~     (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1~     and/or TSC2 mutations (changes in deoxyribonucleic acid [DNA]).Sapanisertib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
763|NCT03047200|"~     The purpose of this study is to further test islet cell transplant in patients who have had~     a kidney transplant. This study will also evaluate the safety and effectiveness of the~     anti-rejection medications used to prevent rejection after your islet cell transplant.~   "
4104|NCT03003585|"~     In this study, the investigators aimed to compare the effects of direct laryngoscopic and~     fiberoptic endotracheal intubation on intraocular pressure.~   "
765|NCT03047174|"~     The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to~     compare the new dressing with the standard skin care. 168 patients receiving radiotherapy~     alone or radiochemotherapy for locally advanced head-and-neck cancer will be included. The~     primary aim is to investigate the rate of patients experiencing severe, stressful radiation~     dermatitis. The skin status will daily be inspected and assessed by specially trained~     doctors and nursing staff.~      It is expected that the new self-adhesive dressing is superior to standard care with respect~     to prevention of grade 2 radiation dermatitis in patients receiving radiotherapy or~     radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to~     become a new standard procedure at the skin care of patients with a head-neck tumor.~   "
766|NCT03047161|"~     Fetal research and clinical practice has been hampered by a lack of suitable investigational~     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy~     and physiology, but it has significant limitations for assessment of cardiac rhythm. The~     proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as~     a new tool for the study of normal and abnormal fetal heart rate and rhythm.~   "
767|NCT03047148|"~     Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory~     and hemodynamic parameters as well as subjective signs of well-being such as absence of~     nausea, vomiting and a low pain level. This investigation intends to compare the rate of~     postoperative complications in the 2 groups from pair matched patient records after regional~     anesthesia with otherwise similar patients after general anesthesia.~   "
768|NCT03047135|"~     Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate~     cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA~     response, and every patient with a radiographic response also had a PSA5 response.~      Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing~     promise in these initial studies, reserving its use for end-stage patients may not be the~     optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in~     roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional~     regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease~     states for prostate cancer.~   "
769|NCT03047122|"~     Mammography is considered the standard imaging method for breast cancer screening, and is~     known to result in reduced mortality from breast cancer. However, the diagnostic yield of~     mammography depends particularly on breast tissue density, with sensitivity as low as 30-48%~     in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as~     it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition~     of hand-held ultrasound to mammography has been demonstrated to significantly increase~     breast cancer detection in women with dense breasts. It is however dependent on the~     expertise and skill of the operator.~      In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for~     use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is~     relatively simple to use, necessitating less technical training, and results in higher~     reproducibility.~      The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the~     detection and classification of breast lesions, compared to hand-held ultrasound, according~     to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS)~     classification. The investigator will also evaluate parameters regarding patients' comfort,~     workflow, and duration of image interpretation.~   "
770|NCT03047109|"~     Spinal anesthesia is widely used as the procedure of choice for cesarean delivery. In~     comparison to epidural anesthesia it is faster, easier to perform, patients are more~     comfortable, complication rates are lower, and it is more cost effective. Spinal anesthesia~     is an accepted technique in elective cesarean sections. However, hypotension, resulted from~     sympathectomy is a common problem, especially in pregnant women.~      Spinal block causes peripheral vasodilation and venous pooling, which may result in maternal~     hypotension. Maternal hypotension after spinal anesthesia for cesarean delivery, without~     prophylactic measures, has a very high incidence (80%-100%). Even though highly~     investigated, spinal induced hypotension remains a major concern, and it has been referred~     to as the Holy Grail of obstetric anesthesia. The detrimental effects of the spinal~     induced hypotension are maternal and fetal. Maternal effects are nausea, vomiting and~     dizziness. Hypotension results in reduced uterine and intervillous blood flow with potential~     fetal hypoxia and acidosis.~      Treatment and prevention of hypotension has been the subject of much investigation and~     controversy. Prophylactic measures include: 1) left lateral tilt, 2) fluid preload, 3)~     vasopressors,4) low dose spinal anesthesia. A 15° left lateral tilt is used routinely during~     cesarean section, to prevent aorto-caval compression, however it is not sufficient as a sole~     method. Left uterine displacement is achieved by tilting the operating table or by placing a~     wedge under the woman's hip. Aorto-caval compression also may increase the spread of spinal~     anesthesia. Among the non-pharmacological interventions studied to minimize the incidence of~     hypotension sitting the patient up for up to 7 min after CSE anesthesia for cesarean section~     reduced intraoperative ephedrine requirement without affecting the success of the spinal~     anesthetic. In contrast, sitting up for 9 min resulted in the need for rescue epidural~     anesthesia without additional benefit.~      Phenylephrine Treatment of vascular failure in shock, shock-like states, drug-induced~     hypotension or hypersensitivity; correction of paroxysmal supraventricular tachycardia;~     prolongation of spinal anesthesia; vasoconstriction in regional analgesia; maintenance of~     adequate level of BP during spinal and inhalation anesthesia. It has a number of important~     attributes for treating spinal hypotension: (i) as an alpha-adrenergic agonist, its~     mechanism of action directly addresses the decrease in systemic vascular resistance~     following spinal anesthesia;(ii) phenylephrine has a faster onset of action compared with~     ephedrine; (iii) ephedrine is associated with a ﬁve-fold increased risk of fetal acidosis;~     and (iv) ephedrine is more likely to cross the placenta and increase concentrations of~     lactate, glucose, and catecholamines in the fetal circulation compared with phenylephrine.~     However, phenylephrine used alone may be accompanied by maternal bradycardia and does not~     beneﬁt from widespread clinical experience, as does ephedrine do. Thus, phenylephrine has~     not yet become popular, particularly for prophylactic use. Clinical experience suggests that~     phenylephrine may be useful in addition to ephedrine when the latter fails to correct~     hypotension.~      Ephedrine sulphate is a potent sympathomimetic that stimulates both α and β receptors and~     has clinical uses related to both actions. Its peripheral actions, which it owes in part to~     the release of norepinephrine, simulate responses that are obtained when adrenergic nerves~     are stimulated. These include an increase in blood pressure, stimulation of heart muscle,~     constriction of arterioles.~   "
771|NCT03047096|"~     The aim of present study is to to investigate whether the combined injection of HA and CS~     was superior than HA alone in the treatment of knee OA.~   "
772|NCT03047083|"~     The purpose of this study is to retrospectively evaluate the treatment patterns and~     AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation~     status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.~   "
773|NCT03047070|"~     Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known~     that bleeding during FESS can affect directly to the visibility of safe landmarks and~     surgical outcomes.~   "
774|NCT03047057|"~     Radical cystectomy remains the gold standard for treatment of patients with muscle invasive~     bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Postoperative~     ileus is the most frequent reason for prolonged hospital stay following cystectomy.~   "
775|NCT03047044|"~     The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use~     additional analgesics as well as a patient controlled analgesia (PCA). The most common pain~     control method of this surgery is the intravenous (IV) PCA. but, if it is relatively~     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce~     the pain intensity effectively. Consequently, it may result in the a lot of rescue~     analgesics requirement, which leads to the adverse effects in patients who are very~     sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be~     low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', we~     can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus~     dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal~     infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be~     increased or decreased according to the patient's use of bolus button. Therefore, this PCA~     device can be implemented to the conventional mode, and added the function of automatically~     controlling the basal rate and administered amount of drug according to the use demand of~     the patient. However, since there are few studies related to this new mode of PCA, more~     research is needed in patients with postoperative pain.~   "
776|NCT03047031|"~     This is an active surveillance study to monitor the real world safety of nintedanib in~     Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been~     assessed in clinical trials. Since only 20 patients from India were enrolled in the INPULSIS~     trials, the safety data on Indian patients is limited. In this active surveillance, the~     safety of nintedanib in IPF patients will be examined in Indian real world setting~   "
829|NCT03046342|"~     Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending~     on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE~     in Pediatric population of Qatar~   "
21930|NCT02770131|"~     Review of clinical characteristics of patients who are prescribed Repatha® and how their~     treatment is managed.~   "
777|NCT03047018|"~     The purpose of this study is to determine if a program can help children with autism who are~     overweight. Specifically, this study will look to see if changes in a child's eating habits~     and exercise can help with weight loss. Investigators also want to see how parents feel~     about the program and if they will complete the entire program.~      Twenty children with autism spectrum disorder (ASD) who are also overweight will participate~     in this study at the Marcus Autism Center. All children who enroll will receive the The~     Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE)~     program. This involves 16 sessions over six months. After the six months, participants will~     come back every month for three months for a follow up visit. Therefore the study will last~     a total of nine months.~   "
778|NCT03047005|"~     This study will test the effectiveness and relative efficacy of naltrexone/bupropion~     medication as a maintenance therapy for the treatment of binge eating disorder (BED) in~     patients with obesity. This is a controlled test of whether, amongst responders to acute~     treatments, naltrexone/bupropion medication results in superior maintenance and longer-term~     outcomes compared with placebo.~   "
779|NCT03046992|"~     YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase~     inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while~     sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain~     metastasis due to good blood brain barrier (BBB) penetration property as well as for the~     treatment of primary lung lesion and extracranial lesions. This study will be conducted to~     evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic~     NSCLC patients with EGFR mutations.~   "
780|NCT03046979|"~     The purpose of this study is to evaluate the efficacy and safety of apatinib in patients~     with advanced HCC.~   "
781|NCT03046966|"~     This study evaluates a new approach to the instruction of pediatric residents in the skill~     of neonatal intubation. Half of the participants will receive focused simulation training~     and cognitive instruction while the other half will not. The collected data from both groups~     will be compared.~   "
782|NCT03046953|"~     The AVAIL-T trial is a trial to find out how effective avelumab is at treating patients with~     primary T-cell lymphoma that is refratory to or has relapsed following initial treatment.~   "
783|NCT03046940|"~     The experiment aims at investigating whether the doctor-patient communication has an~     influence on patients' willingness to take medication. Patients' attitude towards the~     medication is manipulated via a critical film sequence. Afterwards patients of the two~     experimental groups have a communication with one of the investigators of the study.~     Patients are told that the investigator is a medical doctor. The doctors either~     communicate in a patient-centered or doctor-centered style with the patient. Patients in the~     control group do not have the possibility to talk to a medical doctor. Afterwards patients~     are offered the aforementioned pill that is supposed to be a cognitive enhancer (actually~     placebo pill). Pill intake is voluntary. The investigators hypothesize that patients in the~     experimental group with the patient-centered style of communication are more likely to take~     the pill than patients in the experimental group with the doctor-centered style of~     communication or patients in the control group.~   "
784|NCT03046927|"~     This project is designed to study the role of vitamin D supplementation on the honeymoon~     phase of type 1 diabetes in children who are on standardized insulin treatment. The results~     could lead to significant changes in the approach to the early phase of type 1 diabetes with~     a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these~     patients on a standardized insulin regimen. The overall goal is to reduce the long-term~     complications of type 1 diabetes.~   "
785|NCT03046914|"~     Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition.~     Previous reports have reported that HLA-B*5801 is an important genetic risk factor~     significantly associated with the development of allopurinol-induced SCAR. However, there~     has been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening~     before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of~     this prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will~     significantly reduce the risk of allopurinol-induced SCAR development compared to the~     historical control.~   "
786|NCT03046901|"~     The purpose of the study is to investigate the safety and efficacy of oral vancomycin in~     patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation.~     The primary endpoint is looking at the effect of the drug on liver function tests, an~     important surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints~     include a decrease in liver function tests at 1 year, changes in bilirubin and adverse~     events. Effective treatment at the onset of PSC recurrence may lead to decreases in disease~     progression, recurrent liver failure, and repeat liver transplantation.~   "
787|NCT03046888|"~     Prospectively randomized study in patients with renal pelvic stones who are candidate to~     standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly~     allocated into two groups, 20 patients in each group. Group A will be scheduled to receive~     routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.~   "
788|NCT03046875|"~     To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord~     Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate~     increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength~     testing of post-injury dominant-side knee extension. Subjects will be tested in both~     Transcutaneous Spinal Cord Stimulation and sham conditions.~   "
789|NCT03046862|"~     <Research Hypothesis> The dynamics of immune systems by cytotoxic chemotherapy and its~     changes by combination with immuno-oncology agents will be uncovered.~      The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is~     feasible and efficacious in chemo-naïve biliary tract cancer.~      <Purpose of the study> To assess the effect of Durvalumab/Tremelimumab in combination with~     gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer~     patients.~   "
790|NCT03046849|"~     The purpose of this study is to find out the proportion of patients diagnosed with Lynch~     syndrome in colorectal cacner patients meeting Chinese Lynch syndrome criteria. Besides,~     this study is aimed to analyze the clinical characteristics and germline mutation of Lynch~     syndrome in Chinese population.~   "
46093|NCT02453672|"~     Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of~     Bevacizumab~   "
791|NCT03046836|"~     Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There~     are significant health and economic burdens associated with AUD and co-occurring IPA, and~     little empirical data to guide treatment efforts. The neuropeptide oxytocin may help~     mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human~     aggression is scant. The proposed study is designed to address these gaps in the literature~     by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and~     aggression among couples with AUD and co-occurring IPA.~   "
792|NCT03046823|"~     The study aims to:~        1. Characterize coronary artery disease (CAD) using CT Angiography (CTA) and scaling power~          law in 100 patients with obesity~        2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity~        3. Compare the differences of cardiac and vascular remodeling in patients with metabolic~          syndrome and those without~   "
793|NCT03046810|"~     Incontinence and the skin irritation (dermatitis) associated with it are common problems.~     Treatment of dermatitis is effective, but requires effective cleaning and application of a~     barrier substance to prevent further contact between urine or feces and the skin. Water~     based cleansing with the addition of a pH balanced cleanser is more effective than standard~     abrasive cleansing with paper or a cloth, and is better tolerated by those with skin~     irritation. Zinc oxide based barriers effectively promote healing and prevent further skin~     damage. Spray forms are less cumbersome and generally preferred, but are difficult to for~     the patient to apply independently given the challenge of accessing the perineum.~      40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center~     will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each~     use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks~     1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will~     be measured using a visual analog scale derived from the quality of life in incontinence~     scale.~      The investigators hypothesize that the device will 1) effectively treat incontinence~     associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.~   "
794|NCT03046797|"~     In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly~     obese patients is maintained through the ventilator, will be studied. Researchers suggest~     that the technique will allow more time for intubation trial rather than conventional~     techniques of intubation without ventilation. the Primary outcome will be the decrease of~     desaturation events during intubation. Secondary variables will include; stress response to~     intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful~     intubation, the time required to intubation and operator satisfaction.~   "
795|NCT03046784|"~     This prospective and observational trial over 55 pregnant women (third trimester) compares~     non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic~   "
796|NCT03046771|"~     Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by~     Emergency Medical Technicians while transporting a patient home from the hospital, can~     improve transitions of care and improve patient safety following hospitalization as measured~     by decreased rates of falls and reduced rates of return to the hospital.~   "
797|NCT03046758|"~     The objective of this trial is to evaluate the safety of the intraperitoneal administration~     of the combination of fosfomycin, metronidazole, and granulocyte-macrophage~     colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated~     appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of~     fosfomycin and metronidazole after intraperitoneal administration.~   "
798|NCT03046745|"~     This study is a multi-center, prospective cohort study which are planned to enroll the 6000~     patients who diagnosed the primary gastric cancer and 12,000 healthy normal cohort~     participants for 5 years. All participants who enrolled in this registry, the participants~     were questioned by the gastric cancer survey and the serum and tissue of these participants~     were analyzed.~      The main aim of this study is~        1. To evaluate the optimal interval of endoscopic screening for early detection of gastric~          cancer and risk factors in Korean.~        2. To evaluate the diagnostic validity of serum biomarker (combining pepsinogen, H pylori~          IgG Antibody, and TFF3) as a screening test for detection of GC in Korean.~   "
799|NCT03046732|"~     Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in~     order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT~     has been associated with better quality of life (QOL) [1-3], reduced morbidity and~     mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients~     receiving tailored transplant education were more likely to complete the transplant~     evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET)~     education program designed by Dr. Waterman, were more knowledgeable about KT and more likely~     to complete KT evaluation than control patients. Currently, there is a lack of standardized~     KT education in Ontario. Traditional approaches have been insufficient in providing the~     necessary education and information to enable patients to make an informed decision about~     their care. To address this issue, the study will assess the impact of kidney transplant~     related education using the Explore Transplant Ontario (ETO) education program on kidney~     transplant-related knowledge and on readiness to consider KT, readiness to consider living~     donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.~      In order to comprehensively measure this impact, 5 variables will be explored.~        1. Readiness to consider DDKT~        2. Readiness to consider LDKT~        3. KT related knowledge in patients~        4. Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after~          administration of ETO~        5. Proportion of patients who have identified at least one potential living donor at 6 and~          12 months after administration of ETO~      The hypotheses are as follows:~        1. Readiness to consider DDKT will be higher in the intervention group compared to the~          control group at follow up.~        2. Readiness to consider LDKT will be higher in the intervention group compared to the~          control group at follow up.~        3. The KT related knowledge of the patients will be higher in the intervention group~          compared to the control group at follow up.~        4. The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after~          the KT education will be higher in the intervention group compared to the control~          group.~        5. The proportion of patients who have at least one potential living donor at 6 and 12~          month after the KT education will be higher in the intervention group compared to the~          control group.~   "
800|NCT03046719|"~     The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative~     analgesia in intravitreal silicone evacutaion surgery~   "
801|NCT03046706|"~     The accepted recommendation after removal of vocal cord lesion is voice rest.This~     recommendation leads to great tension among the patients, loss of working days and need to~     practice speech therapy.The investigators hypothesize that voice rest after surgery does not~     affect the quality of the patient's voice. The investigators will divide the patients into 2~     groups: the first group will be instructed for a postoperative voice rest and the second~     group will not. Later the investigators will compare the results and conclude whether voice~     rest had any significance.~   "
802|NCT03046693|"~     Clinical trial.gov~      Brief summary :~      Non-arteritic anterior ischemic optic neuropathy (NAION) is an optic neuropathy due to acute~     or subacute ischemic event of anterior optic nerve axons retrolaminar part that was~     vascularized by posterior ciliary brevis artery. The incidence of ischemia will be followed~     by axonal edema and causing compartment syndrome and heighten the incidence of ischemic.~      In NAION, the main pathology occurs at the level of the optical nerve, the axons of retinal~     ganglion cells. Initial damage is on the optic disc ischemia resulting hypoxic injury of~     axons and manifest as disc edema. Axonal edema cause disturbances of retrograde axonal~     transport of neurotrophic factors, especially brain derived neurotrophic factor, to the~     retinal ganglion cells. This will trigger a secondary toxicity and apoptosis. In addition,~     the presence of oxidative stress, calcium influx and mitochondrial damage will also triggers~     apoptosis. After the apoptosis of retinal ganglion cells, there was a thinning of the~     retinal nerve fiber layer (RNFL) through Wallerian degeneration. Thinning of the RNFL will~     manifest as visual field defects and the decline in visual acuity in patients with chronic~     phase NAION.~      Though NAION include disease entity that has long existed, but until now, there has been no~     evidence-based study on medical or surgical procedures that is effective enough to overcome~     NAION. The main treatment is to manage the risk factor such as hypertension, dyslipidemia,~     diabetes mellitus, hypercoagulable state. In general, if the patient is in the acute phase~     (edema of optic nerve head), methylprednisolone administration may be considered, but if the~     patient is already on chronic phase (atrophy disc) which generally occurs 6-11 weeks after~     the onset, then steroids are no longer indicated. Neuroprotective agent was considered as~     treatment in NAION given primary pathology NAION is the retinal ganglion cell axons. Among~     the various neuroprotective substance, Citidine diphosphocoline (CDP-choline~     5'-diphosphocholine or Citicoline) is a therapeutic option NAION.~      Citicoline is an endogenous mononucleotide consisting of ribose, cytosine, pyrophosphate,~     and choline. Citicoline is a component intermediates in the synthesis of phospholipids in~     cell membranes, ie phosphatidylcholine. Exogenous citicoline administered orally or~     intravenously, will be split into citidine and choline. Citicoline via oral administration~     can be absorbed completely and have a similar bioavailability in the blood compared to~     parenteral administration such as intravenous. Once absorbed, citicoline will be distributed~     throughout the body and enter the blood-brain barrier and the blood retinal barrier~     penetrate into the central nervous system. If there is damage to neurons, exogenous~     citicoline will participate in the synthesis of phospholipids in the neuronal cell membrane.~     Some studies show that citicoline may have a neuroprotective effect on retinal ganglion~     cells and supporting regeneration of damaged neurons in vitro. Previous research on the~     citicoline effect in chronic phase NAION give satisfactory results. Dopaminergic~     neurotransmitter systems known to occur in vast numbers in the retina and post-retinal~     visual pathway. Retinal ganglion cells using certain subtypes of dopamine as a means of~     communication with the visual cortex. Rejdak et al in animal models showed that citicoline~     administration could improve and strengthen the dopamine transmission in the retina.~     Citicoline also a safe medicine, without serious adverse effect.~      Electroretinogram (ERG) is a tool to measure the function of the retina. ERG examination can~     measure electrical changes in the retina after light stimulus. ERG examination that can~     detect changes in the activity of retinal ganglion cell is a pattern ERG. Spectral-domain~     optical coherence tomography is a tool that can measure the thickness of retinal ganglion~     cells.~      Thinning of the RNFL will manifest as visual field defects in patients with NAION. The~     typical visual field defects of NAION is altitudinal defects associated with segmental edema~     optic nerve head.~      Based on these descriptions question arises whether the citicoline supplementation can~     repair damage to the neurons of the retina, especially the retinal ganglion cells, in NAION~     resulting in improved retinal function which can be judged from the improvement of the value~     of the amplitude of the wave of P50 and N95 in the examination pattern ERG (PERG) when~     compared with placebo ? In addition whether citicoline supplementation can increase the~     thickness of retinal ganglion cells assessed using SD-OCT? Does citicoline supplementation~     give the effect of improving visual field defects in patients with NAION?~   "
851|NCT03046043|"~     The purpose of this study is to evaluate the efficacy of additional ablation targeting~     complex fractionated atrial electrogram area within low voltage zone identified by high~     resolution mapping in patients with persistent atrial fibrillation.~   "
803|NCT03046680|"~     Hypertension is a multifactorial clinical condition, it may not cause symptoms and its~     diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage~     an adequate blood pressure.~      There are several hypotheses for the non-control of blood pressure, among them the~     difficulty of lifestyle change, irregular treatment with antihypertensive drugs,~     non-individualized treatment. Studies haven shown that tools such as multiprofessional team~     and hypertension leagues are important strategies to obtain a better outcome in the~     hypertension treatment, but new approaches are still necessary. Health Coaching is an~     individualized form of follow-up, promoting better adherence, better nutrition, smoking~     cessation, regular physical exercise and regular use of drugs, thus reducing cardiovascular~     mortality.~   "
804|NCT03046667|"~     The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of~     both genders with frequent occurrence of stomach trouble.This intervention trial with 6~     weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and~     a control beverage without β-glucans. The primary aim is to investigate whether β-glucans~     from barley has an effect on stomach and intestinal health, including stool volume and~     frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate,~     acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and~     exhaled hydrogen and methane, before and after the intervention, subjective perception of~     gastrointestinal problems and digestion as well as the participants' attitudes towards~     functional foods are measured using Visual Analog Scale (VAS).~      Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic~     metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed~   "
805|NCT03046654|"~     Cervical cerclage is an obstetric intervention used in women with poor obstetric histories.~     After recruiting the participant, Trans vaginal sonography will be used to examine cervical~     length and funneling. In addition vaginal examination will be performed to evaluate the~     cervix. After placing the cerclage, the participant will be invited every 4 weeks for a~     follow up evaluation session in order to examine the cervix and cerclage position. .~   "
806|NCT03046641|"~     Duration of exercise is an important factor among the medical guides for weight loss.~     However, there is still little knowledge about other its models in middle-aged and older~     men. The present study aimed to determine the effects of the interval training on weight~     loss and lipid profile, and to compare its efficiency with the continuous training.~   "
807|NCT03046628|"~     The aim of this study is to test the feasibility of using polarised green laser and CMOS~     camera in order to assess the tissue perfusion of lower extremity ulcers in patients~     suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen~     tension examination which is currently the gold standard examination.~   "
808|NCT03046615|"~     For procedures involving proximity to the nerves responsible for eye movement, the need to~     monitor eye movement exists. The current solution is to place needles in the muscles~     surrounding the eye. The Investigators have invented a non-invasive electrode and software~     designed to monitor eye movements non-invasively. The electrode is placed on the skin on the~     corner of the eye and using the natural dipole of the eye, detects the horizontal and~     vertical movements of the eye. The Investigators would like to prove efficacy compared to~     the standard monitoring.~   "
809|NCT03046602|"~     The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for~     parents.This anxiety could have repercussion on parents adaptation on their new environment,~     on parent's role and also on their relaional interaction with the baby. As StJoseph hospital~     receives an important number of premature babies, the neonatology service aim to evaluate~     the real life experience of mothers during the transfer to set up improvement axes with~     hospital departments upstream.~   "
810|NCT03046589|"~     Primary Objectives:~        1. To determine the safety and tolerability of single and multiple oral doses of DP13 in~          healthy male subjects~        2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as~          dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects~      Secondary Objectives:~        1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male~          subjects~        2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male~          subjects~   "
811|NCT03046576|"~     Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset~     atherosclerosis, and our previous study has found that the DPP4a was significantly lower in~     MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is~     associated with no-reflow and major bleeding events in STEMI patients during hospital stay.~     As no-reflow phenomenon and major bleeding events independently associates with a worse~     in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with~     long-term follow-up adverse cardiovascular events in these patients.The hypothesis was~     tested in this study.~   "
812|NCT03046563|"~     Experimental research design with two-group repeated-measure design. The investigators~     estimate there are recruit fifty patients from related rehabilitation hospital of a medical~     center in Taichung, central Taiwan, using randomization put patients in experimental group~     and control group. Experimental group Pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST~     25) and abdominal massage for eight minutes total, press once in the morning and afternoon,~     seven days total and two days for follow the trail. Research tools to self semi-structured~     questionnaire collected data on patient's diet, activity, medication, defecation patterns,~     subjective defecation feelings, and auscultation bowel sounds like. The investigators~     expected the results of this study can provide clinical nursing care for stroke patients of~     reference, to improve quality of care, and increase acupressure to improve the empirical~     data of stroke in patients with constipation.~   "
813|NCT03046550|"~     This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.~   "
814|NCT03046537|"~     Detection of metabolic state of women with polycystic ovary using NA-Nose.~   "
815|NCT03046524|"~     Objectives:~        1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical~          neoplasms~        2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and~          have a different impact on the health of the patients~   "
5285|NCT02988115|"~     The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe~     versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.~   "
816|NCT03046511|"~     An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis.~     Catheter insertion has been associated with infectious complication such as Exit Site~     Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the~     technique because the need of catheter removal. Most of international guidelines recommends~     the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous~     single injection before the procedure. For the last 25 years our unit gives a single~     intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this~     study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure~     intraperitoneal single dose administration of the same drug.~   "
817|NCT03046498|"~     Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP)~     into WellConnect.~   "
818|NCT03046485|"~     120 Patients with visual acuity <6/12 will be randomized to receive either usual care or~     participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We~     hypothesize that a structured self-management low-vision rehabilitation program provides a~     greater improvement in participation in daily activities, and improves quality of life in~     vision-impaired people compared to the provision of the usual low vision rehabilitation~     services. We also plan to document barriers that prevent patients with low vision (visual~     acuity <6/12) from participating in self-management course.~   "
819|NCT03046472|"~     Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from~     32% to 66%. This prevalence gets higher with age and among 17 years old it`s equal to~     prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to~     the next one, hence we should do preventative care at a young age, even before the first~     attack occur. Poor posture was found as one of the risk factors for Low Back Pain in~     children. Adolescence with neutral posture had less prevalence of Low Back Pain then those~     with poor posture. Prolong slouch sitting was associated with Low Back Pain. Prevention~     education programs, focusing on knowledge, did not show effective change in posture~     behavior. Hence, the researchers concluded that it`s better if they focus on exercise.~      Research Goal: comparison between physical therapy treatment for good posture once a week~     versus once a month, on postural behavior, thorax curve angle and Low Back Pain.~      Research type: randomize, Interventional, blinded. Methods and Procedures Population: the~     study will include 50 children and adolescents age 10-18 years suffering from poor back~     posture, with or without Low Back Pain.~      Procedure: The study will consist of two groups: both groups will get personal meeting once~     a month and a program of exercising at home every day. Treatment group will have in addition~     group meeting once a week and control group not. The intervention program will include~     physical awareness and practice for good posture, and exercises for flexibility, strength~     and muscle endurance.~      Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural~     observation for measuring postural habits. Back pain and postural habits questionnaire for~     measuring postural knowledge and habits of participant, including demographic data. Parents'~     questionnaire for measuring parents' knowledge and ideas.~      Research hypothesis: postural behavior, thorax curve angle and Low Back Pain will get better~     in both groups but more in the treatment group.~   "
820|NCT03046459|"~     This is an open-label, single ascending dose study to characterize the safety and PK/PD~     profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2~     family.~   "
821|NCT03046446|"~     This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to~     Patients with Osteoarthritis of the Knee~   "
822|NCT03046433|"~     This study is a multicenter and prospective cohort study of children diagnosed with asthma.~     Clinical symptoms and signs, quality of life, blood test, and lung function were detected~     every three months. FeNO detection, chest imaging, and induced sputum smear were detected~     when necessary. Biological samples will be collected when recruiting and finishing~     follow-up.~   "
823|NCT03046420|"~     This study is exploratory in nature and seeks to describe hypertension diagnosis and~     management among patients in long-term care (LTC) facilities.~      Specifically, the primary objective is to:~      • Identify LTC patients who are diagnosed with hypertension and assess the management and~     different outcomes of proper control of BP regarding to incidence of falls, cognitive~     decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents~      The secondary objectives are to:~      Describe treatment patterns of hypertension in LTC facilities~        -  Identify patients who are receiving non-pharmacological treatment and effectiveness of~          this modality of treatment.~        -  Identify different classes of drugs used to treat hypertension in patients staying at~          LTC facility~        -  Identify different drug adverse effects encountered by patients receiving medical~          treatment.~        -  Identify patients who achieved normal blood pressure according to current guidelines~   "
824|NCT03046407|"~     This project intends to transplant the clinical grade human embryonic stem cells derived~     retinal pigment epitheliums into subretinal space of patients to treat dry age-related~     macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants~     to treat dry AMD.~   "
825|NCT03046394|"~     One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet~     will be tried six times in random order by the patient. The patient will be an active~     prosthetic foot user who walks several kilometers per day and was amputated at the~     trans-tibial level because of injury. Gait pattern will be rated in comparison with the~     patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the~     patient. One-leg standing and 10-meter walking tests will also be performed.~   "
826|NCT03046381|"~     Schnitzler's Syndrome (SchS) is a late-onset multifactorial autoinflammatory disease~     characterized by chronic urticarial skin lesions and a monoclonal gammopathy usually~     belonging to the immunoglobulin M (IgM) or IgG class. Symptoms associated with SchS are~     recurrent fever attacks, bone and muscle pain, arthralgia or arthritis, fatigue and~     lymphadenopathy. SchS is a rare disease with approximately 300 cases reported in the~     literature. The nature of SchS is chronic without known reports about spontaneous~     remissions. Disease onset occurs around the age of 50. About 15% of patients eventually~     develop a lymphoproliferative disorder, most often Waldenström's macroglobulinemia. The~     pathogenesis of SchS is still not well defined. Functional ex vivo studies showed excessive~     cytokine production (IL-1ß, IL-6 and IL-18) of peripheral blood monocytes (PBMCs) in SchS as~     compared to healthy controls. In addition to excessive IL-6 secretion from PBMCs IL-6 has~     repeatedly been reported to be elevated in the serum of SchS patients too. As IL-6 plays a~     major role in the development of multiple myeloma, IL-6 may also be associated with the~     formation of lymphoproliferative disorders in SchS.~      Until now, there is no approved standard therapy available for the treatment of SchS.~     Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and other immunosuppressive~     agents have been reported to provide variable relief from symptoms of bone pain and~     arthralgia. Case reports and small studies about successful treatment of SchS with anti-IL-1~     blockers (anakinra, rilonacept and canakinumab) accumulate. However, there have been~     complete and partial treatment failures to anti-IL-1 blockade in SchS. In these patients,~     anti-IL-6 treatment (tocilizumab [TCZ]) demonstrated to be very effective in reducing the~     clinical symptoms and inflammation markers in SchS. TCZ treatment has proved to be very~     effective, well-tolerated and safe in other acquired autoinflammatory disorders, systemic~     juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease that share many~     clinical features (rash, fever, joint involvement, lymphadenopathy, fatigue) and excessive~     cytokine production with SchS. The study consists of a run-in baseline period of 1-4 weeks~     followed by an open-label 20-week TCZ treatment phase with weekly s.c. injections (TCZ~     162mg), followed by an optional study extension up to a total of 1 year with ongoing once~     weekly TCZ 162mg injections and a 4 week period of follow-up.~   "
830|NCT03046329|"~     The overarching objective of this study is to evaluate the symptom assessment and management~     behaviors used by multiple myeloma (MM) providers for alignment with evidence-based~     practices, and to explore changes in these symptom care behaviors from baseline to following~     use of the Carevive Care Planning System (CPS). The overarching goal of the larger program~     of research is to evaluate the impact of the platform on symptom assessment and management~     strategies with individuals receiving treatment for multiple myeloma. The current study is~     focused on determining feasibility of research methods and effect size finding so as to~     gather the requisite data needed to design fully powered hypothesis testing studies.~   "
831|NCT03046316|"~     This is an open randomized control clinical study, which aims to investigate the overall~     benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who~     do not progress after front line systemic therapy (chemotherapy or target therapy).~   "
832|NCT03046303|"~     This study is a prospective, single-center, randomized controlled trial. The study protocol~     was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is~     combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with~     advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group~     and conventional pathway group . Inter-group differences were evaluated for clinical~     recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term~     survival, etc.~   "
833|NCT03046290|"~     The authors study the efficacy of the pudendal versus penile block for the relief of~     postoperative pain in children receiving ambulatory circumcision.~      In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited~     during the anesthesia consultation will be allocated a general anesthesia with a pudendal~     block (PUD group) or a penile block (PEN group).~      Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).~   "
834|NCT03046277|"~     Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease~     in patients undergoing lung transplantation~   "
835|NCT03046264|"~     There is growing evidence that central blood pressure is a better predictor of hypertensive~     end-organ damage and cardiovascular outcome than routine brachial readings.~      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive~     determination of central blood pressure based on automated oscillometric radial pulse wave~     analysis.~   "
836|NCT03046251|"~     The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery,~     is effective in preventing postpartum relapses.~   "
837|NCT03046225|"~     Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a~     prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the~     postoperative period of TKA, the pain is intense and limits the mobility of patients, so the~     analgesia is one of the goals of the physical therapy. One of the alternatives available for~     pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by~     the application of an electric pulsed current through electrodes positioned on the skin.~     Therefore, the present study aims to evaluate the acute effects of TENS associated with~     conventional physical therapy compared with conventional physical therapy on the pain level,~     knee range of motion and administration of morphine in the rehabilitation of patients after~     TKA.~   "
838|NCT03046212|"~     Transcutaneous electrical nerve stimulation (TENS) is characterized by the application of an~     electric pulsed current through electrodes positioned on the skin. It can be an alternative~     for pain management after surgery for total hip arthroplasty (THA), since it is a safe and~     cost-effective therapeutic tool, allowing the patient to move early due to pain relief.~     Therefore, the study aims to evaluate the acute effects of TENS associated with standard~     physical therapy compared with standard physical therapy on the intensity of pain, hip range~     of motion and morphine consumption in the rehabilitation of patients after THA.~   "
839|NCT03046199|"~     Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant~     medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people~     over 40 in France. COPD is responsible for a significant impairment of quality of life and~     was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.~      However, about 75% of patients with COPD are not diagnosed. Spirometry is the only~     examination for the diagnosis of COPD. Patients identified at risk for COPD are~     insufficiently using spirometry and general practitioners (GPs) underestimate the severity~     of COPD when they do not practice spirometry in their patients. COPD is often diagnosed too~     late, the disease being discovered at the stage of complications requiring hospitalization.~     The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in~     accessing a specialist performing spirometry, their reluctance to perform spirometry, and~     the insufficient involvement of general practitioners.~      Currently in France, targeted screening for COPD and diagnosis in primary care is a major~     challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not~     indicate a systematic screening in the general population for COPD but advocate targeted~     screening of patients by five questions to identify risk factors and symptoms of COPD. The~     presence of at least one of these factors in an adult over the age of 40 requires~     spirometry.~      Recent studies suggest the relevance of finding primary care variables for smoking and~     respiratory symptoms in order to identify new cases of COPD.~      However, the impact of the use of these questionnaires on the prevalence of diagnoses of~     COPD in general practice has not been demonstrated. Moreover, the heterogeneity of the~     provision of care according to the territories limits a fast or easy access (distance) to~     the spirometry.~      It is therefore necessary to evaluate in primary care the interest of a targeted screening~     of COPD and the interest of a coordination of care for the realization of a spirometry, in~     order to improve the rate of diagnosis of the disease.~   "
840|NCT03046186|"~     After gastric sleeve patients undergo a substantial weight loss, but the physiological~     mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone~     secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however~     to which extent is not fully established and furthermore, the mechanisms behind an altered~     secretion are unclear. The purpose of this study is to investigate absorption and~     postprandial metabolism of glucose and protein in addition to gut hormonal responses after~     gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI.~     Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI,~     current BMI, sex and age will be included for comparison.~   "
841|NCT03046173|"~     To investigate the effects of concentrated growth factors applied in maxillary sinus floor~     elevation via a lateral window approach with simultaneous implant placement on repair of~     bone defects and new bone formation.~   "
852|NCT03046030|"~     The aim of this proposal is to investigate brain response and connectivity changes evoked by~     video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy~     and patient populations to elucidate the underlying brain mechanisms of mind-body~     interaction, imagery, and acupuncture.~   "
5862|NCT02980445|"~     The purpose of this study is to determine whether improved outdoor time has an effect on the~     onset and progression of myopia in children.~   "
842|NCT03046160|"~     Background: Dyskinesia has been referred to as a major manifestation of affected muscle~     performance and neuromuscular control of the scapular stabilizers. Alterations around the~     scapula with muscular imbalances could facilitate or emphasize dysfunction in its~     surrounding structures through compressive and shear stresses created by abnormal pull~     through attachments. No studies have investigated the effect of scapular mobilization with~     movement on neck mobility and pain. Objective: To quantify the effects of utilizing a~     scapular mobilization with movement on cervical pain and range of motion as compared to~     conventional treatment under the presence of scapular dyskinesia. Design: an experimental~     case-control study. Setting: Dammam Medical Complex. Methods: thirty-four patients with~     chronic non-specific neck pain. Participants will be allocated to one of two groups:~     experimental group where treatment will involve conventional and manual interventions or the~     control group where treatment will consist of the conventional approach only. The manual~     intervention will consist of a sustained corrective scapular glide during neck movement in~     all directions. Measurements will include: Visual Analog Scale, pressure pain threshold,~     neck range of motion, scapular rotation measure and Neck Disability Index. Statistical~     analysis: all will be done using SPSS version 22.0 for Mac. Means and standard deviations~     will be given as descriptive statistics. Paired t-test will be used to study the effects of~     scapulothoracic mobilization and exercises on neck range of motion and pain intensity.~     Independent t-test will be used to compare the effects of the two interventions on pain~     intensity Key words: Pressure pain threshold; Scapula; Intervention, Manual therapy,~     mobilization.~   "
843|NCT03046147|"~     Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether~     RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to~     investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing~     (forearm) regions before and after maximal weight loss at 1 year and after weight~     stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be~     studied at fasting and during oral glucose tolerance test.~   "
844|NCT03046134|"~     Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and~     mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death.~     Community-acquired pneumonia (CAP) represents not only a frequent complication but also a~     deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD~     patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13~     (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population~     has not been studied yet.~      Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high~     pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior~     pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients.~     However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were~     evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial~     effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age~     group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in~     COPD patients because COPD is the disease of old ages and mortality rate increases~     exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the~     waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the~     best option for the prevention of pneumococcal pneumonia in COPD patients, there are few~     available studies supporting it.~      In this study, we will conduct prospective, multi-center trial with the collaboration of~     Korean pulmonologists in five university-affiliated hospitals. In this study, we will~     evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia~     severity, and clinical outcomes of hospitalized pneumonia patients with COPD.~      If successfully accomplished, this study will enhance the awareness of the preventive use of~     PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to~     protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and~     deadly complication.~   "
845|NCT03046121|"~     This study will address the effectiveness of Family-centered Function Focused Care~     (Fam-FFC). Fam-FFC is a theoretically-based approach to care in which family caregivers~     partner with nurses to prevent functional decline and other complications related to~     hospitalization in older adults with Alzheimer's disease and related dementias. A systematic~     care pathway promotes information-sharing and decision-making that promotes physical~     activity, function, and cognitive stimulation during the hospitalization and immediate~     post-acute period. Our goal in this work is to establish a practical and effective way to~     optimize function and physical activity; decrease neuropsychiatric symptoms, delirium, and~     depression; prevent avoidable post-acute care dependency; and prevent unnecessary~     rehospitalizations and long-stay nursing home admissions, while mitigating family caregiver~     strain and burden.~   "
846|NCT03046108|"~     The aim of this work trial is to compare the effectiveness of blind and ultrasound guided~     injection for Morton neuroma in order to determine which is more appropriate as the initial~     procedure in conservative treatment~   "
847|NCT03046095|"~     It is well known that periods of weight training lead to increases in skeletal muscle size~     and strength. In contrast, periods of inactivity such as bed rest or immobilization result~     in losses of skeletal muscle size and strength. However, individuals experience variable~     magnitudes of muscle size change in response to changes in mechanical tension, such that~     certain individuals experience large changes in muscle mass whereas others do not. What is~     not currently known, and will be the primary goal of the present investigation, is to~     determine whether individuals who gain the most muscle mass with exercise training also lose~     the most muscle when they are immobilized. The investigators hypothesize that individuals~     who gain the most muscle with training will also lose the most with immobilization.~   "
848|NCT03046082|"~     Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU~     with pneumonia.~   "
849|NCT03046069|"~     Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease~     (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting),~     long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled~     corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these~     three classes of medication is recommended. This study aims to explore the potential utility~     of a device called single inhaler triple combination or Trelegy ELLIPTA inhaler containing~     all three groups of compound. This is a mixed methods study with a qualitative phase and a~     quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages:~     qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of~     the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany~     and approximately 573 subjects with COPD will be included. ELLIPTA is a registered trademark~     of the GlaxoSmithKline (GSK) group of companies.~   "
850|NCT03046056|"~     The primary objective of this study is to evaluate the efficacy of filgotinib, when compared~     to placebo, in establishing clinical remission in participants with Crohn's disease~     involving the small bowel. Participants will have the option to enter a separate long-term~     extension study if they meet eligibility requirements.~   "
25163|NCT02727816|"~     The aim of this non-dispensing study is to evaluate the clinical performance of different~     hydrogel contact lens designs.~   "
854|NCT03046004|"~     The aim of this study is to assess the effect of receiving information about the benefits~     and harms of mammography screening on informed choice, decisional conflict, intention to~     participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The~     primary outcome is informed choice about breast screening (adequate knowledge, and~     consistency between attitudes and intentions). The sample of participants is composed by 400~     women from Catalonia and the Canary Islands (Spain) who will receive their first invitation~     to participate in the EDBCP of the Public Health Service in a period of 2-4 months.~   "
855|NCT03045991|"~     The purpose of this study is to determine the treatment effects of sequential combination of~     aerobic exercise and cognitive training on cognitive function, physiological markers, daily~     function, physical function, social participation and quality of life in stroke patients~     with cognitive decline.~   "
856|NCT03045978|"~     To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1,~     IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in~     children with feeding difficulty, and further to evaluate their regulation with feeding~     difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical~     conditions).~   "
857|NCT03045965|"~     HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to~     examine if opportunistic salpingectomy compared with no salpingectomy, at the time of~     hysterectomy for a benign reason~        -  has no increased risk of complications~        -  has no negative side effects on ovarian function and subsequent cardiovascular disease~          or incidence of fractures~        -  implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be~          conducted within national registers.~   "
858|NCT03045952|"~     Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with~     favorable long-term outcomes.Butthe results are mainly from single center reports.A larger~     scale data need to be analyzed to evaluate the technique. This study is designed to~     investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer~     (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and~     December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA~     as a primary treatment will be enrolled from at least ten Chinese institutions with~     different levels of MWA experience. All the patients will be closely followed up until June~     2019. Clinicopathologic data, recurrence and survival estimates, complications and~     prognosis-relative factors will be measured.~   "
859|NCT03045939|"~     This study will evaluate the insertion of double balloon device (DBD) for cervical ripening~     for 12 h vs 6 hours.~   "
860|NCT03045926|"~     The main purpose of this study is to assess the concentration of elemental impurities in~     blood and urine after chronic administration of Smecta® in subjects with chronic functional~     diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel~     microbiote composition will be investigated.~   "
861|NCT03045913|"~     This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
862|NCT03045900|"~     There is a deficiency in literature which compares the blending effect and color matching of~     translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in~     this research color matching and blending effect will be instrumentally measured the by a~     spectrophotometer. A visual assessment also will be done in-vivo and ex-vivo.~   "
863|NCT03045887|"~     This study is the first administration of GSK2292767 to humans. The study will evaluate the~     safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat~     inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient~     confidence in the safety of the molecule and preliminary information on target engagement to~     allow progression to further repeat dose and proof of mechanism studies. This is a two part,~     single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will~     consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and~     pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder~     inhalation. Part B is planned to follow Part A and progression will be based on an~     acceptable safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat~     doses of GSK2292767 once daily for 14 days during Part B.~   "
864|NCT03045874|"~     The purpose of this study is to conduct community-engaged research (CEnR) with families and~     pediatric providers caring for the children in those families to address the following~     specific aims:~        1. Examine parents' knowledge and perceptions about their 6-36 month old children's sleep~          and objective characteristics of sleep, including (1a) self-reported and~          actigraph-recorded characteristics of sleep, sleep habits, and difficulty; (1b) the~          contributions of sleep habits and individual, family, community, cultural/social, and~          health-related factors to sleep characteristics and sleep difficulty; (1c) consequences~          of sleep difficulty; (1d) successful and unsuccessful strategies used to promote~          children's sleep and sleep habits; (1e) preferences regarding sleep promotion~          interventions for their children; and perceptions of the optimal timing to begin sleep~          promotion intervention~        2. Examine pediatric primary care providers' perceptions about (2a) the importance of~          sleep and sleep habits for 6-36 month old children; (2b) factors that contribute to~          sleep habits and sleep difficulty; (2c) successful and unsuccessful approaches to~          promote healthy sleep habits, adequate duration and good quality sleep and assessment~          and management of sleep difficulty in young children within the context of their~          families; and (2c) barriers, facilitators, and preferences regarding sleep-promoting~          interventions for families with young children;~        3. Collaborate with families and providers to use the information obtained in Aims 1 and 2~          to develop and refine a feasible, relevant, and acceptable sleep promotion program,~          including procedures, protocols, patient materials, intervention fidelity plans, and~          delivery methods.~   "
875|NCT03045731|"~     The purpose of this study is to establish an ultrasound mathematical model using acoustic~     radiation force impulse (ARFI) and contrast-enhanced ultrasonography (CEUS) for diagnosing~     the status of renal allografts.~   "
968|NCT03044522|"~     This multicenter randomized (block randomization) controlled parallel arm pilot study~     comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that~     treat chronic non cancer pain patients with opioid analgesics. Subjects who are either~     opioid naïve or opioid experienced will be enrolled into the study.~   "
865|NCT03045861|"~     GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the~     treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This~     study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study.~     This study will be conducted in two Parts (Part A and Part B) consisting single daily doses~     of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study~     will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the~     relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered~     across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects~     will be studied in Part I followed by interim (go/no-go) analysis of Part A data. On~     completion of an interim analysis of part A data, further cohorts of 8 subjects will then be~     studied in Part B in a parallel design in two or more cohorts (depending upon the data~     obtained in Part A). Approximately 34 HIV-1 infected treatment-naive subjects will be~     enrolled during the study. Subjects in both parts will have a screening visit within 30 days~     prior to first dose and a follow-up visit 7-14 days after the last dose. Maximum duration of~     study participation will be approximately 6 Weeks.~   "
866|NCT03045848|"~     LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent~     (Biofreedom, Biosensors International Technologies, Singapore) in patients with high~     bleeding risk. But, there are limited clinical evidences for extending these findings to~     generalized patients who are eligible to PCI. Therefore, the purpose of this registry is to~     evaluate the safety and efficacy of Biofreedom stent in patients with coronary artery~     disease.~   "
867|NCT03045835|"~     Baska mask is a new novel supraglottic airway device with many salient features. The~     investigators aim to determine the benefit of BASKA mask as an effective airway device for~     laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order~     to smoothen the surgery and anaesthesia process in ambulatory care setting as well as reduce~     perioperative complications.~   "
868|NCT03045822|"~     There are an increase number of patients with cardiac implantable electronic devices (CIEDs)~     such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The~     current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this~     group of patients to avoid any electromagnetic interference. These recommendations restrict~     the use of BIA in many patients with heart failure in whom BIA might be of great interest in~     detecting peripheral congestion and in guidance of treatment. However, it is not well known~     whether BIA can affect the function of cardiac devices. Investigators aimed to test the~     incidence of electromagnetic interference between BIA and CIEDs.~   "
869|NCT03045809|"~     The current standard of care for urogenital infections in Rwanda is syndromic management.~     Many urogenital infections are asymptomatic and therefore completely missed, and the~     management of vaginal discharge syndrome is known to be suboptimal. The primary objective of~     this study is to evaluate whether it is feasible to improve urogenital infection care in~     high risk women in Kigali, Rwanda, using point of care (POC) diagnostic testing for HIV,~     Trichomonas vaginalis (TV), and bacterial vaginosis (BV) in all women; POC testing for~     Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and syphilis in pregnant women and~     women assessed to be at high risk for these infections using a risk scoring questionnaire;~     and management of vaginal candidiasis, urinary tract infection (UTI), genital~     ulcers/inguinal bubos, and lower abdominal pain in women reporting relevant symptoms. The~     secondary objectives of this study are 1) to evaluate the performance and 2) cost~     effectiveness of the POC tests for CT/NG, TV and BV; and 3) to obtain the opinions of~     Rwandan stakeholders.~   "
870|NCT03045796|"~     Previous research has shown that many patients with kidney failure undergoing chronic~     hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease~     during dialysis treatments. This may be due to a variety of factors including anemia,~     compromised pulmonary function, and chronic fluid volume overload. Previous studies have~     shown that low venous oxygen concentrations may increase the risk of cardiovascular events,~     cognitive deficits, and mortality in HD patients.~      The purpose of this study is to identify patients with hypoxemia during HD treatments and~     characterize the extent of and implications of their hypoxemia. Specifically, the~     investigators aim to examine the relationship between central venous oxygen concentration~     and hemodynamic changes during dialysis treatment. The investigators will evaluate the~     relationship between cardiac output as measured by the Task Force Monitor and central venous~     oxygen saturation as measured by the Crit-Line Monitor and Wrist0x2 in HD patient. Data from~     this study will provide insight into potential mechanisms responsible for side effects~     associated with dialysis treatment, such as drops in blood pressure and cognitive~     dysfunction.~   "
871|NCT03045783|"~     The purpose of the study is to evaluate the efficacy and safety of prophylactic use of~     antibiotics in endoscopic injection of tissue adhesive in gastric varices.~   "
872|NCT03045770|"~     The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and~     FOLFPTX as first-line treatment in AGC or EGJA.~   "
873|NCT03045757|"~     The overall goal of this study is to describe the oral motor skills of neonates born with~     congenital heart defects, both before and after cardiac surgery, and to evaluate current~     measures of feeding motor skills and feeding readiness in this population using the Neonatal~     Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale.~      The specific aims are to:~        1. Describe the oral motor skills of infants with CHD before surgery as compared with~          normal full-term newborn (>37 weeks) using the NOMAS~        2. Describe the oral motor skills of infants with CHD after surgery as compared with those~          same infants before surgery using the NOMAS.~        3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies~          which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B.~          Quality of Nippling Scale at the 1st post- operative feeding evaluation)~        4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide~          jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have~          dysfunctional sucking patterns before surgical repair as compared to normal newborns.~          This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery~          as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be~          utilized to predict that many infants with CHD will not be ready for oral feedings,~          however most of those patients will go on to successfully take oral feedings.~   "
876|NCT03045718|"~     The objective of this study is to determine whether horticultural therapy would improve the~     psychological well-being older adults who are at risk of memory (cognitive) decline. 100~     elderly subjects who are at risk of cognitive decline will be randomized into the active~     horticultural therapy or to the waitlist control group. Sessions will be conducted weekly~     for 9 months, and participants will be assessed at 3 time-points: at the start of the study,~     at 3 months and at 9 months.~      It is hypothesized that participants who undergo horticultural therapy will perform better~     on neuropsychological tests when compared to control, and that they will have improved~     psychological well-being and functional outcomes.~   "
877|NCT03045705|"~     In the current study the investigators wish to evaluate the effect the doctors and midwives~     in the delivery room have on the timing and modality of analgesia chosen by the~     participants. The participants will be randomly divided into 2 groups. Both groups will be~     advised of the different modalities of analgesia available during labor. One group will be~     managed in the delivery room the same as if not part of the study, meaning the doctors and~     midwives will treat the participants the way they usually do regarding analgesia. The second~     group of participants will not be asked by the doctors and midwives about analgesia at all~     but will be able to receive analgesia by a modality of choice at the timing of choice.~   "
878|NCT03045692|"~     The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute~     to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill~     patients. In control group, colistin maintenance dosage will be decided using serum~     creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be~     decided using 4hr CrCl.~   "
879|NCT03045679|"~     The aim of this prospective randomized controlled trial is to compare the two procedures~     One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass~     (RYGB) in relation to intraoperative and postoperative complications (classification of~     Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus,~     hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life,~     operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.~   "
880|NCT03045666|"~     48 patients, over the age of 18, with pulmonary arterial hypertension classified as WHO~     III-IV, that are all stable under Macitentan therapy, will be recruited to the study through~     the pulmonary hypertension clinic at Soroka Medical Center. The patients will be randomly~     divided into an intervention group, which will exercise twice a week for 12 weeks,~     supervised by physiotherapists, and a control group, which will only receive the medication.~     Tests will be performed before the beginning of the intervention program, 6 weeks after it~     has begun, at the end of the 12 week program, and 3 months after finishing the program.~   "
881|NCT03045653|"~     Background: Endocrine therapy is an effective and safe treatment for hormone receptor~     positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is~     an urgent need for treatment alternative. Laboratory researches and clinical case reports~     indicate that hormone receptor-high expressed breast cancer patients may potentially benefit~     from high-dose Tamoxifen therapy, providing a new option for treatment strategy.~      Aim: To explore the efficacy and safety of high-dose Tamoxifen to advanced hormone~     receptor-high expressed endocrine therapy resisted breast cancer.~      Methods: Eligible patients will be treated with tamoxifen 100 mg/d. Blood and tumor samples~     will be obtained from the patients.~      Primary endpoint: clinical benefit rate at 16 weeks(CBR)~   "
882|NCT03045640|"~     Study activities were carried out to adapt and test a family-strengthening intervention to~     improve child development outcomes among families facing adversity in Rwanda.~   "
883|NCT03045627|"~     Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite~     induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen~     ) has been widely used in China for the treatment of acute myeloid leukemia (AML).~     Strategies to reduce the toxicity associated with intensive chemotherapy include the~     attenuated doses of standard regimens and myeloid growth factors. Granulocyte~     colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of~     chemotherapy-induced neutropenia，but requires daily administration because of its short~     half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting~     reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of~     Shandong University and other well-known hospitals in China.In order to report the efficacy~     and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute~     Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).~   "
884|NCT03045614|"~     Evaluation of the prevalence of kidney disease, hemodynamic predictors and long-term renal~     outcome in patients with pulmonary hypertension.~   "
885|NCT03045601|"~     Invasive coronary angiography is currently considered gold standard in the assessment of~     coronary artery disease although the method has limitations. Most importantly invasive~     angiography only depicts coronary anatomy without determining its physiological significance~     i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional~     flow reserve (FFR) is a catheterization technique for assessing the physiological~     significance of a coronary artery lesion during invasive coronary angiography. Coronary~     computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an~     alternative route to diagnosis for patients with suspected coronary artery disease.~     Computational fluid dynamics combined with anatomical models based on CCTA scans allows~     determination of coronary flow and pressure, and has emerged as a promising diagnostic~     modality called CT-FFR. In this Project New Mathematical algorithms are developed for~     computation of CT-FFR. The main objective of this study is to determine the diagnostic~     accuracy of CT-FFR values obtained by the new method compared with invasive coronary~     angiography with fractional flow reserve and state-of-the-art dobutamin stress~     echocardiography.~   "
886|NCT03045588|"~     The investigators will examine the long-term effects of a combined training and diet~     intervention that, acutely, increases fat oxidation during exercise. This is done with a 4~     week intervention study with moderately trained cyclists. Performance is tested pre and post~     intervention and muscle biopsies are obtained.~   "
896|NCT03045458|"~     The present study was compared the level of alveolar bone loss, clinical parameters and~     IL-1β in PICF in one- or two-stage surgical procedures. Half of the patients were performed~     tissue level implant while other half were performed bone level implant.~   "
887|NCT03045575|"~     This is a prospective observational study designed to determine the feasibility and~     acceptability of objectively measuring physical activity, sedentary time, and sleep using~     the Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and~     are planning to initiate chemotherapy will be invited to participate in this study, and we~     will measure general and breast-specific quality-of-life using PROMIS measures for 3-6~     months after completion of chemotherapy.~   "
888|NCT03045562|"~     To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion~     in subjects with STEMI who underwent primary PCI~   "
889|NCT03045549|"~     The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system~     - SWORD Phoenix- in the rehabilitation after total hip replacement . SWORD Phoenix allows~     the patients to perform independent rehabilitation sessions at home, under remote monitoring~     from the clinical team. The investigators hypothesise that the clinical outcomes of a~     home-based rehabilitation program will be at least similar to the outcomes of a traditional~     home-based rehabilitation with face-to-face sessions. This is a randomised controlled trial~     with active comparator. Patients will be enrolled and allocated pre-operatively into 2~     groups: intervention group and control group. Both groups will perform 8 weeks of~     rehabilitation starting on day 7 after surgery. The intervention group will perform daily~     rehabilitation sessions at home using SWORD Phoenix, under remote monitoring from a physical~     therapist. The control group will perform 1h rehabilitation sessions 3 times a week, at~     home, given by a physical therapist. Outcomes will be measured at weeks 4 and 8. The primary~     outcome is the performance in the Timed-up-and-Go (TUG) test between in each patient in~     comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a)~     range of motion of the hip joint (flexion/extension/abduction/adduction/internal and~     external rotation); b) Hip Osteoarthritis Outcome Score; c) quality of life, as measured by~     the SF-36 scale.~   "
890|NCT03045536|"~     Several surgical options for the reconstruction of massive bone defects have been described~     and include biologic methods with autografts and allografts, and the use of tumor~     endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available,~     but nevertheless unpredictable outcomes and high complication rates have been described from~     most authors. The aim of the present study was to compare complication rates after TFR~     performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with~     and without malignant disease.~   "
891|NCT03045523|"~     This clinical study is a phase IIa, multi-center, randomized, double-blind,~     placebo-controlled, parallel group study to evaluate two doses of orally administered~     GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR~     mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.~      Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must~     be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days~     at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active~     doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days.~     Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from~     screening until the follow-up visit.~   "
892|NCT03045510|"~     Myelodysplastic syndrome (MDS) is widely recognized as a clonal hematopoietic stem cell~     disorder. Decitabine has been approved for the treatment of all subtypes of myelodysplastic~     syndrome (MDS). However, the use of decitabine is often limited by its severe toxicity~     represented by myelosuppression even at relatively low doses. In lower-risk patients~     (including IPSS low and int-1 risk groups), treatment mainly aims at improving cytopenias,~     especially anemia. However, although several drugs may improve anemia, sometimes durably,~     most of lower risk MDS eventually require red blood cell (RBC) transfusions during their~     disease course. Long term RBC transfusions lead to iron overload mainly due to an increase~     in reticulo-endothelial iron recycling.Cardiac, liver and endocrine (diabetes mellitus)~     dysfunction due to iron overload and often leading to fatal outcome has been reported in~     heavily transfused lower risk MDS patients.~      To date, the optimal regimen for decitabine treatment is not well established. In this~     study, we perform a prospective analysis to explore the decitabine schedule for the~     treatment of lower risk myelodysplastic syndrome patients with transfusion dependent.~   "
893|NCT03045497|"~     This pilot clinical trial compares the use of contrast-enhanced ultrasound to~     contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in~     predicting treatment response in patients with liver cancer receiving transarterial~     chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before~     and after transarterial chemoembolization may help doctors predict a patient's response to~     treatment and help plan the best treatment. It is not yet known if contrast-enhanced~     ultrasound works better than contrast-enhanced MRI in predicting treatment response in~     patients with liver cancer.~   "
894|NCT03045484|"~     Background:Although concurrent chemoradiotherapy is effective for improving disease-free~     survival and overall survival in patients with locally advanced nasopharyngeal carcinoma.~     However,the oral mucositis pain evoked by the chemoradiotherapy itself reduces food intake~     and frequently halts the treatment. Thus, pain control is an important problem in~     chemoradiotherapy for nasopharyngeal carcinoma.We performed to examine whether early~     induction of low-dose, opioid from moderate pain reduced total dose of Oxycodone during~     chemoradiotherapy, while improves the quality of life and reduce weight loss.~      Objective:Present clinical trial to investigate the early introduction of opioids suppressed~     the transient increase in the numeric rating scales(NRS) score for pain and compared with~     conventional treatment.~      Methodology:The subjects will recruit 130 patients who were hospitalized for nasopharyngeal~     carcinoma. 130 patients were divided into two groups, depending on whether the pain was~     moderate or severe when an opioid was introduced.Differences between groups were compared~     using T test protected least significant difference for one-factor analysis of variance. All~     statistical analyses were performed using SPSS(Statistic Package for Social Science)~     software.P-values < 0.05 were considered statistically significant.~   "
895|NCT03045471|"~     1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated~     CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for~     patients with AIDS associated CD20+ diffuse large B lymphoma.~   "
7550|NCT02958384|"~     The overall purpose of this study is to explore the therapeutic effect of LeY-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of myeloid malignancies.~   "
897|NCT03045445|"~     Hypothesis: double low-dose protocol provide better lesion conspicuity than standard~     protocol CT in patients at high-risk of HCC.~      patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this~     study and allocated to either standard protocol or double-low dose protocol using spectral~     CT with low radiation dose and low dose of contrast media, within clinically accpetable~     range.~   "
898|NCT03045432|"~     Several factors associated with the hemiplegic shoulder pain after stroke includes rotator~     cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of~     shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and~     brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency~     ultrasound to evaluate the relationship between stroke patients with poor shoulder motor~     function and shoulder tendon injury. Also, assumed that performing passive range of motion~     and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder~     pain in either acute or chronic stage of stroke.~   "
899|NCT03045419|"~     It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide~     additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to~     reduce the necessity of biopsy in patients with high risk of HCC.~      Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced~     MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.~   "
900|NCT03045406|"~     Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective~     randomized open blinded end-point (PROBE) study~   "
901|NCT03045393|"~     The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects~     the amount and activity of folate receptor alpha proteins in tumor cells of patients who~     have completed standard neoadjuvant treatment and are scheduled to have their tumors~     surgically removed.~   "
902|NCT03045380|"~     The study was designed to investigate the effect of video games based physical activity~     training on upper extremity functions, walking, balance and cognitive functions in persons~     with multiple sclerosis (MS). For this aim, the participants with MS will be divided into~     three groups: game based physical activity training, conventional rehabilitation, and no~     intervention groups. The experimental groups will receive therapy sessions once a week for 8~     weeks. The no intervention group will receive no intervention, they will be assessed at~     baseline and after 8 weeks.~   "
903|NCT03045367|"~     This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge~     vitrectomy and phacoemulsification with intraocular lens implant in patients with~     metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All~     30 patients recruited underwent complete ocular examination, visual acuity measurement with~     ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness~     evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.~   "
904|NCT03045354|"~     The purpose of this study is to determine the effect of carbohydrates of familiar breakfast~     meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and~     overweight or obese (OW/OB) children.~   "
905|NCT03045341|"~     This study will test the effectiveness and relative efficacy of behavioral and pharmacologic~     treatments, alone and in combination, for the treatment of binge eating disorder (BED) in~     patients with obesity. This is an acute treatment comparing behavioral weight loss alone or~     in combination with naltrexone/bupropion medication.~   "
906|NCT03045328|"~     This phase I/II trial studies the side effects and best dose of venetoclax when given~     together with ibrutinib and to see how well they work in treating patients with chronic~     lymphocytic leukemia or small lymphocytic lymphoma that has come back or does not respond to~     treatment. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
907|NCT03045315|"~     Previous studies in animal model showed clearly that lipid homeostasis influence oocyte~     meiosis resumption. However Liver X Receptors pathway has never been investigated in human~     ovocyte~   "
908|NCT03045302|"~     The purpose of the protocol is evaluate the safety, the pharmacodynamics and the~     pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.~   "
909|NCT03045289|"~     This research will examine the feasibility of conducting a strict whole-food, plant-based~     dietary intervention with intensive group education in women with stable metastatic breast~     cancer currently undergoing conventional treatments. In addition, this research will provide~     preliminary data on dietary intakes and the effect of plant-based nutrition on numerous~     outcomes reflecting cancer prognosis and overall health using advanced imaging, various~     blood biomarkers linked to cancer progression, and numerous symptom questionnaires.~   "
910|NCT03045276|"~     The overarching goal of this five-year, phase II, randomized clinical trial is to improve~     poor long-term health outcomes in both adolescents and young adults (AYA) with either a~     kidney transplant (KT) or spina bifida (SB), respectively. More specifically, this study~     will focus on decreasing premature allograft loss in subjects with kidney transplant (KT)~     due to medication nonadherence and kidney damage in subjects with SB due to urinary~     non-continence. To achieve these goals, this study will implement a real-time feedback~     system, Way to Health (WTH), that will provide education and support, increase awareness and~     incentivize positive health behavior, in addition to standard of care. Further, this study~     will investigate the mechanisms of behavior change by examining the role of financial~     incentives, positive feedback and the relationship between the two. The study will compare~     two cohorts of KT and SB subjects, which will undergo varied levels of financial incentives~     and positive feedback. Data from KT and SB subjects will be analyzed jointly and separately.~     This innovative mobile health (mhealth) strategy will improve our current measures of~     adherence and increase our understanding of factors that influence adherence for two AYA~     populations, KT and SB subjects, respectively. The study will contribute novel insight to~     inform the design of future interventions targeting persistence of behavior change and can~     be used in other centers and for other chronic disease groups.~      The study intervention will use the WTH web-based platform to support AYA with KT or SB as~     they navigate their daily treatment burdens. This will be achieved via bi-directional text~     messaging, including the sending of reminders and positive feedback by WTH and the messaging~     of pictures of medication or catheter in hand at time of treatment by the participant. This~     intervention will assess sustainability of this novel bi-directional messaging system and~     the impact of providing education and support, increasing awareness and incentivizing~     positive health behavior in real-time.~   "
969|NCT03044509|"~     1. The primary objective is to improve the sensitivity of novel immunodiagnostic tests for~          detection of TB disease in children.~        2. The secondary objective is to determine biomarkers that discriminate children with TB~          infection and disease.~   "
1171|NCT03041883|"~     The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen~     crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the~     graft used as a support for the Boston keratoprosthesis (KPro) type I against corneal~     melting (keratolysis or sterile necrosis).~   "
911|NCT03045263|"~     The purpose of this study is to evaluate the application of a modified version of PRT~     designed specifically as a parent-training model via telemedicine, with the goal of~     increasing access to empirically validated care. The project will feature an 18-week trial~     of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children~     with ASD. Intervention will focus on enhancing the following developmental skills:~     expressive and receptive language, play, and social interaction. Outcome measures will~     address changes in the aforementioned domains during structured observation and standardized~     assessment.~   "
912|NCT03045250|"~     Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in~     subjects with Type 1 Diabetes.~   "
913|NCT03045237|"~     Sporty Bellies is an intervention program with pregnant women, based on the promotion of~     healthy lifestyles. It aims to evaluate the impact of the program in the health of both~     pregnant and newborn. This trial is being conducted with 313 pregnant women, divided into~     control and intervention group. Are performed 3 assessment periods: 1 - beginning of the~     program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of~     3 weekly physical exercise classes and the control group has the basic information that is~     usually provided by health professionals. With this program, it is expected to contribute~     with evidence to the best practice in the field of interventions in pregnancy and improve~     health outcomes of both pregnant and newborn.~   "
914|NCT03045224|"~     The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and~     follow-up patients with peripheral arterial disease undergoing endovascular peripheral~     intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists,~     and radiologists contributed actively to this registry.~   "
915|NCT03045211|"~     When postural imbalance and gait difficulties emerge in subjects with Parkinson disease,~     patients are typically referred for a number of physical therapy sessions. However, there is~     a critical gap in clinical practice on what to do once patients have completed their therapy~     sessions. To fill this gap, the study team has developed a standing table with a tabletop~     system that encourages weight shifting during upright standing (dynamic standing table),~     and therefore may be a unique means to increase daily physical activity by integrating the~     system with routine desktop activities of daily living. The purpose of this study is to~     determine whether a post-physical therapy in-home physical activity program using the~     dynamic standing table (as an adjunct to post-physical therapy standard of care—weekly~     physical activity group sessions) is effective in sustaining the mobility benefits of~     physical therapy in individuals with Parkinson disease.~   "
916|NCT03045198|"~     In collaboration with Dr.Birgit Alteheld, Institute of Nutrional Sciences of the university~     of Bonn, Germany the following effect is explored: Effect of a 4 week therapy with AZT on~     synthesis of lipoproteins as well as Docosahexaen and other fatty acids in patients with~     Cystic Fibrosis (CF). Moreover proinflammatory cytokines in blood and sputum are of~     interest.~   "
917|NCT03045185|"~     Aim: The aim of this prospective study was to evaluate the treatment outcomes of~     regenerative endodontic technique (RET) for the management of traumatised non-vital immature~     teeth in children. Methodology: This study aims to recruit 25-30 healthy children with~     traumatised non-vital immature upper incisors to be treated with bi-antibiotic regenerative~     endodontic technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years~     and radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments,~     clinical reviews and standardised radiographic exposures. Radiographic analysis will be~     carried out by two calibrated experienced clinicians. Standardised photographs will be taken~     at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised~     validated methodology.~   "
918|NCT03045172|"~     Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS~     causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which~     may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop~     vulvar cancer.~      The current gold standard treatment for lichen sclerosus is potent steroids creams. When~     used correctly, steroid creams help to decrease the symptoms of itching and burning and can~     prevent further vulvar scarring. In addition, proper treatment reverses the underlying~     inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams~     may have serious side effects that include thinning of the skin, fungal infections, and~     lowering the immune system.~      Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing,~     without serious side effects, in a very wide range of medical conditions such as diabetic~     foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP~     works because of its high level of proteins that help with wound healing. It is also~     apparent from the majority of published studies that PRP therapy has minimal risk of scar~     tissue formation or significant bad side effects.~      Recently, there was an exploratory study of twelve subjects that used PRP for the study~     treatment of lichen sclerosus. While this study showed good success, the study was limited~     because of its small size and lack of placebo (a drug or study treatment that contains no~     active ingredient) control.~   "
919|NCT03045159|"~     The purpose of this research is to evaluate the efficacy of the Strong Families Strong~     Forces Parenting Program compared to a parental self-care (Strong Parents) condition in a~     sample of 150 Active Duty Families with children ages birth to 5 years.~   "
920|NCT03045146|"~     FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a~     prospective multi-center study to determine if multimodal imaging could identify patients~     who may and those who may not benefit from an endovascular clot removal procedure within 6~     hours after stroke onset.~   "
939|NCT03044899|"~     STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult~     surgical patients in Africa.~      STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study~     of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum~     of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study~     design.~      The primary outcome is in-hospital postoperative complications in adult surgical patients in~     Africa. Secondary outcomes include in-hospital mortality and the relationship between~     postoperative complications and postoperative mortality.~      The intention is to present a representative sample of surgical outcomes across all African~     countries. This study will run between February and March 2016.~   "
921|NCT03045133|"~     Introduction. Despite the advantages associated with the use of remifentanil during total~     intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of~     postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated~     with the administration of this opioid. There is evidence that NMDA receptors are involved~     in the development of these changes. Methadone is an opioid that exhibits analgesic potency~     similar to that of morphine but has NMDA antagonist activity and longer duration of action~     as additional features. The objective of the study was to evaluate the quality of recovery~     (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received~     morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years,~     physical status ASA I and II, submitted to total venous anesthesia (propofol and~     remifentanil) for laparoscopic cholecystectomy and eligible to participate in this~     prospective and randomized clinical study will be evaluated. After induction of anesthesia,~     patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1~     methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness,~     presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be~     recorded at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale~     (ENV) from 0 to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group)~     will be administered every 15 minutes to obtain the score below 3. After discharge from the~     PACU, all patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6~     hours. For cases where the patient considers the analgesic regimen insufficient, tramadol~     (100 mg) will be administered intravenously at 8-hour intervals. The consumption of~     analgesics, the intensity of pain, the occurrence of nausea, vomiting and other~     complications in the ward will be recorded. The application of the questionnaire (QoR40)~     will be performed in the ward the morning after the surgery by a medical student.~   "
922|NCT03045120|"~     This non-interventional, prospective study will characterize the impact of three approved~     first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and~     metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and~     initiating first-line TKIs in routine clinical practice in the US. All treatment decisions~     will be determined at the discretion of the treating physician(s) and data identifying the~     cardiovascular and metabolic risk factors will be collected. Additional fasting blood~     samples (collected following 8 hours of fasting) will be collected during standard of care~     (SOC)/routine office visits. Additional research imaging will be performed and will be~     reviewed by core imaging laboratory. As the study is collecting data on management of CML,~     this study will not influence the prescribing or management practices at participating~     sites.~   "
923|NCT03045107|"~     During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic~     anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with~     extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However,~     the level of evidence coming from the currently available literature is low, based on the~     results of a few small and heterogeneous retrospective non-randomized studies. A randomised~     controlled trial is warranted to challenge these two procedures. The aim of this randomized~     controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right~     colectomy for right colon tumors.~   "
924|NCT03045094|"~     This study evaluates the effect of head and neck movement in children on endotracheal tube~     (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be~     measured using flexible fiberoptic bronchoscope.~   "
925|NCT03045081|"~     To develop and test a web-based patient empowerment platform, PainTracker Self-Manager~     (PTSM), that can support integrated multimodal care in a variety of specialty and primary~     care settings. The investigators will adapt PainTracker, a web-based outcome and treatment~     tracking tool already deployed in multiple University of Washington clinics to create the~     PTSM self-management tool that helps assess, engage, activate, and support patients' efforts~     to self-manage their chronic pain in collaboration with their clinicians. PTSM design will~     be based on 4-phase patient engagement strategy derived from Acceptance and Commitment~     Therapy. Phase 1 focuses on achieving consensus on the clinical problem definition,~     treatment goals and timeline. Phase 2 focuses on promoting values-based action and~     acceptance of pain. Phase 3 focuses on providing skills in chronic pain self-management with~     close monitoring of patient reported outcomes and actigraphy. Phase 4 focuses on providing~     autonomy support to promote maintenance of self-management behaviors. Phase 5 involves~     generating a patient registry with the above data for use in quality improvement research.~     The investigators will engage patients, providers and investigators in designing PTSM,~     reviewing prototypes, and conducting usability testing. In a 6-month clinical trial, the~     investigators will compare 50 intervention patients from the UW Center for Pain Relief who~     receive PTSM to 50 historical control patients who have received the basic PainTracker. The~     primary outcome will be patient activation, with secondary outcomes of: chronic pain~     self-efficacy, chronic pain acceptance, perceived efficacy in physician-patient~     interactions, patient and provider satisfaction. Development of the PTSM platform will~     support the dissemination of the multimodal interdisciplinary care for chronic pain that is~     recommended in the National Pain Strategy, and may help chronic pain care meet the goals of~     the Triple Aim: better patient experience, better patient outcomes, with lower costs.~   "
926|NCT03045068|"~     Hypothesis:~      Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and~     administration of donor apheresis platelets just prior to termination of bypass will assist~     in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood~     products after cardiac surgery.~      Background:~      What is the Problem? - Bleeding, Transfusion and Outcomes~        1. Excessive bleeding after neonatal cardiac surgery has been independently associated~          with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal~          open-heart surgery has multiple etiologies such as immaturity of the building blocks of~          coagulation, effects of deep hypothermia, longer CPB times, altered flow states and~          dilutional state induced by being on CPB leading to low platelet count, low platelet~          function, low fibrinogen levels, altered fibrinogen polymerization, complement~          activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass~          in children was deemed to be the CPB circuit volume and the effect of hemodilution.4~        2. The dilutional coagulopathy after neonatal CPB requires intense damage control~          resuscitation with massive transfusion of platelets, packed red blood cells (PRBC),~          cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a~          previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in~          neonates undergoing open-heart surgery there was a significant drop in platelet counts~          after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated~          with this drop , the average intraoperative transfusion load in neonates undergoing~          cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51±~          21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10~          ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex~          concentrate (Bebulin®). Although this throw the kitchen sink approach is effective in~          achieving hemostasis, it comes with significant effects on post CPB hemodynamics,~          constantly changing hematocrit, variable blood volume with inability to achieve steady~          state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary~          hypertension.~      Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass~     has distinct advantages of reducing transfusions and improving outcomes.~   "
940|NCT03044886|"~     The object of the study was to evaluate the direct effect of high dose vitamin D~     supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.~   "
941|NCT03044873|"~     The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the~     systemic exposure of rosuvastatin in healthy participants.~   "
942|NCT03044860|"~     Investigation of the anatomical distribution of enteroendocrine cells by a systematic~     approach along the entire human intestinal tract in healthy individuals and patients with~     type 2 diabetes.~   "
943|NCT03044847|"~     The purpose of this study is to establish the large COPD cohort and biological database in~     China, aiming for precision medicine to optimize diagnosis and treatment choices and to~     monitor and improve clinical outcomes in this disease.~   "
8425|NCT02946944|"~     Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in~     the treatment of patients with intermediate-high risk of pulmonary embolism~   "
927|NCT03045055|"~     Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly~     90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug~     or endovascular treatment is the most effective strategy to reduce brain damage. However,~     after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may~     not only weaken the therapeutic effects of timely reperfusion but also impede patients'~     recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have~     been proved to be unsuccessful in clinical trials. Therefore, effective strategies are~     urgently needed to prevent and treat cerebral reperfusion injury and further improve the~     prognosis of acute ischemic stroke.~      Researchers applied remote ischemic conditioning to mouse model of focal cerebral~     reperfusion injury and found that it could reduce cerebral infarct size. And clinical~     researches demonstrated that remote ischemic conditioning was an effective strategy to~     improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke.~     However, whether remote ischemic conditioning is safe and effective in protecting patients~     with large-vessel ischemic stroke and undergoing endovascular treatment is still unknown.~     The investigators' hypothesis is that RIC is a safe, feasible and effective strategy to~     reduce cerebral reperfusion injury after endovascular treatment.~   "
928|NCT03045042|"~     This study aims to analyze serum and plasma samples from patients with late onset Pompe~     disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA~     that could be specific of the disease. The investigators will correlate the concentration of~     these microRNA with several muscle function tests and quantitative muscle MRI to know~     whether they are good biomarkers of progression.~   "
929|NCT03045029|"~     This is a prospective, observational, multicenter, patient registry to observe and assess~     the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly~     initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who~     transition from another prostacyclin therapy will be evaluated for 52 weeks to observe~     dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and~     clinical outcomes of interest.~   "
930|NCT03045016|"~     After a traumatic event such as an accident or an assault, victims may experience intense~     stress symptoms that may evolve into post-traumatic stress disorder (PTSD). It is a~     frequent and serious pathology, which can be complicated by depression, addiction or~     suicide. Few means are available to prevent PTSD in people who have just undergone trauma.~     Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to~     stop the vicious circle of stress and prevent the development of the disease. The objective~     of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who~     visit an emergency department after trauma.~   "
931|NCT03045003|"~     The aim of this phase II study is to test by feasibility and efficacy of two~     interprofessional supportive care interventions with different intensities to facilitate~     resilience in patients and thereby to reduce their unmet supportive care needs.~   "
932|NCT03044990|"~     Several epidemiologic studies reported that patients with renal insufficiency might have~     increased cardiovascular disease-related mortality rates after Percutaneous coronary~     intervention (PCI) . The increased risk in this population may be related to the less use of~     standard guideline-based treatment and the resulting inability to perform PCI effectively.~     Recently, with the technology improvement and the progress in clinical trials, Chinese~     guidelines have made new recommendations about the patients with acute coronary~     syndrome(ACS) in different states of renal function. However, scant epidemiologic~     information exists on the prognosis of those patients, especially in Henan. And there is~     still some uncertainty whether those patients are using the latest guideline recommended~     treatment.~      This multicenter, prospective, observational study is aimed to evaluate the long prognosis~     in patients with acute coronary syndrome complicated with renal insufficiency, and to~     analysis its related factors that influence the outcomes.~   "
933|NCT03044977|"~     This study is designed to identify the best tolerated doses of [131]Iodine-MIBG and~     [90]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs~     (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently,~     the safest and best tolerated doses of these drugs (when combined together) is unknown.~   "
934|NCT03044964|"~     The post-marketing study is designed to evaluate the activity level and exercise tolerance~     of patients with deferred percutaneous intervention due to FFR (fractional flow reserve)~     greater or equal to 0.81 and treatment with Ranolazine versus placebo.~   "
935|NCT03044951|"~     It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon~     versus radiofrequency ablation for paroxysmal atrial fibrillation.~   "
936|NCT03044938|"~     Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and~     healthy subjects. To prevent these symptoms frequently they have to use Short-Acting~     Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise~     remain poorly known.~      Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during~     exercise in patients with moderate or severe asthma and healthy individuals.~      Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals~     with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59~     years.~      Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg~     Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn.~     During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory~     flow will be monitored.~   "
937|NCT03044925|"~     Compare the safety and efficacy of remote magnetic navigation-guided ablation and~     cryoablation for patients with persistent atrial fibrillation.~   "
938|NCT03044912|"~     Recent phase III trials have confirmed the efficacy and safety of mirabegron in the~     treatment of overactive bladder (OAB) in Europeans, Australians, North Americans, Japanese~     and Asians. Whether mirabegron 25mg or 50mg should be used as the first line treatment for~     OAB has not been determined yet. The dose effectiveness relationship between 25mg and 50mg~     mirabegron has also not been investigated yet. Hence, investigators have conducted this post~     marketing study in order to evaluate the efficacy and safety between mirabegron 25mg and~     50mg in Taiwanese people with symptoms of OAB.~   "
966|NCT03044548|"~     This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to~     improve health outcomes and quality of care of children with malnutrition~   "
944|NCT03044834|"~     Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent~     malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma~     Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were~     identified in 2009.~      Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid.~     Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is~     possible from type 1 to type 2 or 3 in 10% of the cases.~      Since 2009, DICER 1 mutations research is proposed systematically to all families.~      PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows~     bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can~     be difficult because of the proximity with congenital cystic adenomatoid malformation.~      The French society of paediatric oncology recommends surgery at first instance. PPB type 1~     remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy~     depends on the PPB type and the quality of the resection. There is a real interest to~     analyse the French series.~      The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1~     survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48%~     in type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary~     invasion and quality of surgery.~      Early local relapses are possible and late ones concern more often type 2 and 3 with more~     cerebral metastasis.~      In 2009, the french cases were collected, but no update has been performed since. The aim of~     this retrospective review of the cases since 2000, is to audit the care of PPB patients in~     France and update the French rare tumour database.~      Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no~     radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion~     and PPB type 1. Radiological presentation is however overlapping. Another aim of this study~     will be to look for a predictive sign of type 1 PPB.~   "
945|NCT03044821|"~     Spina bifida is a neurological abnormality characterized by an opening in the skin and~     exposure of the spinal cord on the back of the baby at the time of birth. The complete~     closure and separation of the spinal cord from the skin occurs in the first month of~     pregnancy.~      This form of spina bifida is associated with leg weakness, sensation loss, and bowel and~     bladder incontinence. The majority of patients (>80%) also develop increased fluid in the~     brain, called hydrocephalus, and require additional surgery to treat this problem. Standard~     treatment of myelomeningocele (MMC) involves closing the opening in the back within the~     first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin~     edges together to prevent infection and injury to the exposed nerves. Of note, this type of~     surgery does not improve function.~      The investigators want to study the open in-utero fetal surgery technique in patients who~     are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of~     35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the~     United States.~   "
946|NCT03044808|"~     Single center double blind RCT. 60 subjects. Giving lidocaine IV or saline to patients due~     to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at~     24 hours.~   "
947|NCT03044795|"~     In tumors with a defect in the homologous recombination (HR) pathway, double-strand break~     repair is partly impaired. Patients with HR deficient tumors benefit from therapies that~     induce DNA lesions requiring HR for repair. These therapies include platinum compounds and~     inhibitors of the enzyme PARP-1. At this moment, selection for PARP inhibitor treatment~     relies on detection of germ-line or somatic mutations in the HR pathway genes BRCA1 or~     BRCA2. However, not all HR deficient tumors have a BRCA gene mutation, the BRCA genes can~     also be silenced by promoter methylation. Moreover, the HR pathway can be defective due to~     mutations in other HR genes. In addition, the presence of a BRCA gene mutation does not~     guarantee defective HR since mutations in other genes (e.g. TP53BP1) can restore HR despite~     the presence of a BRCA1 mutation. Since all patients with tumors that are HR deficient may~     benefit from PARP inhibition, better tools are required to identify these patients.~     Recently, a functional ex vivo test for HR deficiency (the RAD51 assay) became available for~     clinical use. The RAD51 assay can identify patients with functional defects in HR-repair and~     may predict which cancer patients are likely to benefit from PARP inhibition. The purpose of~     this study is to investigate whether the RAD51 assay can select patients who will benefit~     from treatment with the PARP-inhibitor veliparib.~   "
948|NCT03044782|"~     The purpose of the current project is twofold; first to determine what personal, historical,~     logistical, and environmental factors preclude women from obtaining medical care for CCCA~     hair loss. Because damage from CCCA is irreversible, early identification and treatment is~     paramount to limiting the negative ramifications of the disease. Second, to investigate how~     CCCA hair loss, a common occurrence in the Black population, can be a significant~     psychological impediment to lives of affected Black women. Based on previous research on the~     psychosocial impact of generalized hair loss in Black women, it is fair to consider that~     CCCA hair loss also leads to problems with self-esteem and participation in daily life~     activities. This research, the first of its kind, will add to existing knowledge of CCCA by~     investigating the quality of life and barriers to care of patients with this condition. The~     goal of this study is to illuminate what stands in the way of secondary and tertiary~     prevention of CCCA patients and tailor treatment strategies to address their needs. The~     results of this study will be instrumental in modifying dermatology resident training,~     adding to existing dermatology management guidelines, and even developing public health~     advocacy programming.~   "
949|NCT03044769|"~     Congenital lung anomalies include different pathologies such as congenital cystic~     adenomatoid malformation, pulmonary sequestration, bronchial atresia, emphysema,~     bronchogenic cyst. They concern less than 1/10000 births and their physiopathological origin~     is still poorly understood. The main goal of this project is to pool the cases from~     different swiss centers on a prospective cohort study, first to increase knowledge of~     clinical and radiological evolution and their correlation with histological data, and second~     to analyse the pathological embryological mechanism underlying these malformations.~   "
950|NCT03044756|"~     Omitting the GnRH antagonist on the day of the trigger can be cost effective and more~     convenient to the women. We will study the impact of omitting the antagonist dose in a~     prospective randomized trial~   "
951|NCT03044743|"~     This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV~     (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be~     collected for research purposes.~   "
967|NCT03044535|"~     The purpose of this study is to develop a measurement system to assess adjustment to~     mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD])~     and health-related quality of life (HRQOL) in patients with advanced heart failure who~     receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory~     Support: Adjustment and Quality of Life (MCS A-QOL).~   "
8426|NCT02946931|"~     To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under~     Japanese clinical condition~   "
952|NCT03044730|"~     The purpose of this study is to see whether a combination of two different drugs -~     pembrolizumab and capecitabine - is safe, and if it might be effective in treating triple~     negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains~     an antibody. Antibodies are the part of your immune system that finds things that don't~     belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and~     blocks a protein, which allows your immune system to target and destroy cancer cells.~     Pembrolizumab is Food and Drug Administration (FDA) approved for other types of cancer. It~     is not approved for breast cancer, meaning that it is an experimental or investigational~     treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and~     FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.~   "
953|NCT03044717|"~     The purpose of this research study is to assess comfort of cardiology fellows and faculty~     with nutrition and its role in cardiovascular disease and to determine if increasing~     education in this arena will change clinical practice.~   "
954|NCT03044704|"~     The study is a prospective-observational, explorative single-centre cohort study aimed to~     examine the influence of hemodynamic and geometric parameters on the progression of~     atherosclerotic alterations in peripheral vessels (carotids, femoral artery).~     Atherosclerotic alterations (IMT, plaque volume) will be measured with a ultrasound (IMT~     measurements and 3D quantitative plaque volumetry) and magnetic resonance imaging (MRI).~     Geometric parameters (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation~     area) are assessed with magnetic resonance imaging (MRI) and also 3D ultrasonography.~      A total of 100 patients with an asymmetrical plaque distribution in carotid and femoral~     arteries will be tested. Only patients who are already enrolled in the Correlation of~     Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin~     (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be~     included in this study. MRI will be performed once whereas ultrasound imaging will be be~     repeated once per year (up to five times) to assess changes in these parameters over time.~     Also plasma samples will be collected once yearly and tested for traditional and novel~     cardiovascular risk factors.~      The primary endpoint of the planned study will be the correlation between geometrical and~     hemodynamic parameters as stated above and the progression of atherosclerosis as measured by~     plaque volume and IMT in the carotid and femoral arteries, respectively.~      Secondary endpoints will include the correlation of geometrical and hemodynamic parameters~     with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors~     (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion~     molecule-1 (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, plaque~     localization, plaque morphology and the additional predictive value of geometrical~     parameters compared to an established risk score (SCORE card).~   "
955|NCT03044691|"~     The primary purpose of our study is to conduct a pilot, practice-based intervention focused~     on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1)~     Anticipate (future use), (2) Ask (about tobacco use), (3) Advise (advise the patient~     to quit using tobacco), (4) Assess (the patient's readiness to quit using tobacco), (5)~     Assist (by setting a quit date, providing materials on quitting tobacco, providing tobacco~     cessation medications, and referring the patient for additional services and/or counseling)~     , and (6) Arrange (by re-contacting the patient after their quit date and arranging a~     follow-up visit).~   "
956|NCT03044678|"~     This study was designed to conceptualize a school-based prevention program or childhood~     anxiety.~   "
957|NCT03044665|"~     The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and~     more emphasized. However, there are also growing concerns that high-intensity statin would~     be related to increased risk of adverse effects. In addition, there was an inconsistency of~     efficacy of statin according to ethnic population. Asian population showed more profound LDL~     reduction not only from high potent statin but from moderate to low potent statin.~     Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore~     doubling of previously described dose of statin would be common way in patients with~     inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative~     strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of~     high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will~     evaluate whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy~     in terms of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin~     monotherapy.~   "
958|NCT03044652|"~     The aim of the study is to gain further experience with regard to the performance of the~     medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.~   "
959|NCT03044639|"~     The randomized, double-blind, multi-centric study performed in four parallel groups to~     compare all lipid emulsions, which can be used as a part of PN. Patients with home~     parenteral nutrition due to stable intestinal failure, were randomly assigned to receive~     parenteral nutrition with one the following lipid emulsions:~        -  Long-chained triglycerides (LCT group)~        -  Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))~        -  Olive oil/ LCT (80:20, OO group))~        -  SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)~   "
960|NCT03044626|"~     AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic~     non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in~     2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous~     NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study~     Group B.~   "
961|NCT03044613|"~     Anti-PD-1 (nivolumab) or Anti-PD-1/CTLA-4 (ipilimumab) administration in the pre-operative~     setting and nivolumab combined with chemoradiation will be safe and feasible in patients~     with resectable distal esophageal/gastroesophageal junction cancer and will change cellular~     and molecular characteristics of the tumor microenvironment that will improve survival.~   "
962|NCT03044600|"~     Objectives:~        1. To better define the differences in molecular genetics of parathyroid tumors in~          patients with MEN1, single gland parathyroid disease in patients less than 50 years old~          and single gland disease in patients greater than 50 years old.~        2. To better define the incidence of HRPT2 mutation in young patients with primary~          hyperparathyroidism and determine whether routine testing in these patients is~          indicated.~   "
963|NCT03044587|"~     AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II~     trial~   "
964|NCT03044574|"~     The aim of the study is to evaluate efficacy and safety of VTE prophylaxis by the~     combination of graduated compression stockings (GCS), standard doses of low-molecular-weight~     heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical~     patients at high and extremely high risk for venous thromboembolism.~   "
965|NCT03044561|"~     The aim of this study is to evaluate the effect of sildenafil citrate on endometrial~     development in women with history of recurrent implantation failure after IVF~   "
25342|NCT02725476|"~     The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related~     Disease (RD) activity~   "
970|NCT03044496|"~     Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular~     changes causing increased arterial blood flow and venodilatation .~      Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing~     oxygen saturation by detecting the absorption and reflection of near-infrared light .~      The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula~     revision has not yet been examined. We postulate an increase in tissue oxygenation by~     sympathicolysis caused by peripheral regional anesthesia that might be the reason for~     beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular~     plexus block in this group of patients.~   "
971|NCT03044483|"~     When infection strikes, the body's immune system reacts by producing chemicals in the~     bloodstream and changes in white blood cells to attack the infecting organism (bacteria,~     viruses or other organisms) and prevent it spreading. This is termed the 'inflammatory~     response'. Though beneficial in fighting infection, this response can sometimes be~     excessive, causing harmful effects on body organs. This is termed the 'systemic inflammatory~     response syndrome' and when linked to infection is termed 'sepsis'.~      Previous research has shown that in patients who have sepsis, the small blood vessels~     supplying oxygen and nutrients to muscles and other organs (the microcirculation) become~     abnormal and do not function as they would in health. However, it is difficult to assess the~     function of microcirculation in clinical practice, and we want to find new, easier ways of~     doing so.~      The aim of this study is to test a new method for assessing the function of these small~     blood vessels, by directly visualising them using a highly sensitive microscope, the size of~     a pen, placed under the tongue. By understanding the flow of blood in these vessels in~     healthy individuals, we will gain a better understanding of how these vessels are affected~     in illness.~   "
972|NCT03044470|"~     AIM : To determine the efficacy of cold saline irrigation in reduction of post operative~     pain following root canal therapy.~      METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth~     were included. The patients were assigned randomly into two groups of 20 patients each. The~     teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group~     2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft~     Parker visual analog scale was used to measure pre-operative pain and post-obturation pain~     at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were~     used for statistical analysis.~   "
973|NCT03044457|"~     A new operation technique was established (reversed gap technique for implantation of~     total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical~     outcome shall be evaluated using the conventional gap technique as control in a RCT study.~   "
974|NCT03044444|"~     In this study, the effect of citrus extract on exercise performance will be investigated.~     The study consists of three groups: one group will receive a high dose citrus extract, one~     group will receive a low dose citrus extract and the last group will receive a placebo.~     After four and eight weeks the effects on performance are measured through a Triple Wingate~     cycling test, handgrip strength, vertical jump and 1600m run trial. It is expected that~     exercise performance will increase in the citrus extract groups, compared to the placebo~     group.~   "
975|NCT03044431|"~     The purpose of the Lung Institute is to collect and isolate a patient's own cells and~     platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung~     Institute's treatment is limited to self-funded patients with chronic lung disease- chronic~     obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary~     fibrosis (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich~     plasma are harvested through venous or bone marrow collection techniques.~      The hypothesized outcomes of therapy are safety and minimization of adverse events, a~     perceived improvement in the patient's lung condition (to be determined by their perceived~     quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce~     supplemental oxygen use, the ability to function well without the use of rescue inhalers,~     reduction of secondary pulmonary infections, reduction in emergency room visits and~     exacerbations related to their disease.~   "
976|NCT03044418|"~     The study examines the special endotracheal laser tube during anesthesia of endolaryngeal~     laser surgery.~   "
977|NCT03044405|"~     The aims of the study are:~        1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;~        2. To assess diagnostic value of different focussed echocardiography parameters to define~          fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after~          major abdominal surgery.~   "
978|NCT03044392|"~     The current standard of practice for the maintenance of epidural analgesia is through use of~     a continuous infusion pump. Enhanced technology now supports the use of programmed~     intermittent bolus (PIEB) administration. This novel drug delivery system provides small~     boluses of local anesthetic and opioid at programmed intervals. Several studies suggest that~     administration of PIEB allows a more extensive spread of local anesthetic in the epidural~     space and provides superior labour analgesia compared to traditional continuous epidural~     infusions. PIEB is associated with lower anesthetic consumption, a shorter second stage of~     labour and greater patient satisfaction.~      The authors are focusing on a PIEB setting known as the Next Bolus. Next Bolus (NB)~     determines when the first PIEB bolus is given after the initiation of the epidural and~     starting the PIEB pump. Currently we set this to be 15-45 minutes. In an attempt to optimize~     resources, authors hope to determine the optimal NB interval that will provide adequate~     analgesia but limit overall drug consumption. An optimally timed next bolus should minimize~     drug costs and limit nurse and physician intervention by decreasing the need for manual~     boluses.Increased local anesthetic consumption can cause undesirable side effects such as~     itchiness, decreased blood pressure and motor blockade. By assigning patients to receive the~     NB at 15, 30 or 45 minutes the authors hope to find the interval that provides analgesia~     while minimizing side effects, improving patient safety. If the bolus is given too late then~     there may be increased pain, less patient satisfaction, and the need for more analgesia in~     the form of Patient Controlled Epidural Anesthesia or a manual bolus.The authors hope that~     determining the NB will result in an institutional change to improve patient outcomes and~     facilitate knowledge transfer. This information will be the first available research to help~     guide other obstetrical centres using PIEB technology in determining the optimal NB~     interval.~   "
979|NCT03044379|"~     Dapivirine Gel Rectal Safety and PK Study~   "
980|NCT03044366|"~     Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of~     rudimentary build, many medical and physical problems have shown in treatment of disease~     such as complications, airway problems, temperature disregulation and deficient drug~     metabolism. This retrospective study evaluates the perioperative management and~     postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for~     retinopathy of prematurity (ROP).~   "
9352|NCT02934815|"~     To test the feasibility of supportive-expressive group intervention (SEGT) for women with~     primary breast cancer and to provide a preliminary test of its efficacy.~   "
981|NCT03044353|"~     The study is intended to evaluate whether monthly repeated courses of administration of~     GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in~     patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and~     echocardiography (ECHO), and whether this is associated with an improvement in cardiac~     function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with~     immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post~     chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy.~     Primary objectives for the study are assessment of reduction in cardiac amyloid load after~     repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and~     assessment of safety & tolerability of repeated administration of Anti-SAP treatment,~     including compatibility with chemotherapy treatment in patients with AL systemic~     amyloidosis. This is an open label, non-randomised, three-group, monthly repeat Anti-SAP~     treatment study in systemic amyloidosis patients with cardiac dysfunction caused by cardiac~     amyloidosis. Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total~     duration for a subject in the study is approximately 18 months.~   "
982|NCT03044340|"~     Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve~     by crisis when the feet extremities become red hot and painful. There are several types of~     EM but this study concern the adult primitive form. For a long time, the physiopathology was~     not described but now we know that there is a vascular form, with microcirculatory~     dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic~     form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an~     electromyography. Thermotest, a medical device which measure the thermic sensitivity is used~     to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to~     chloride ions detect small nervous fiber in diabetic patients with good correlation with~     Thermotest.~      The purpose of this study is to analyze the vascular side and the neurologic side on~     patients consulting for Erythromelalgy.~   "
983|NCT03044327|"~     The aim of this study is to further profile and develop the Lipopolysaccharide, endotoxin~     (LPS) challenge models (both by instillation and inhalation) by investigating the utility of~     various non-invasive monitoring methods.~   "
984|NCT03044314|"~     This study will compare the clinical efficacy of inhaled iloprost as an invasive, selective~     vasodilator in the cardiac catheterization laboratory in patients with pulmonary~     hypertension to the gold standard of inhaled nitric oxide. It will also examine whether~     echocardiographic estimates of response to inhaled iloprost can predict responsiveness to~     invasive vasodilator testing in patients with pulmonary hypertension.~   "
985|NCT03044301|"~     The aim of this study is to evaluate the performance of the ZENEO needle free device in~     subcutaneous functioning limits (low performance limit and high performance limit) and for~     intramuscular injections.~   "
986|NCT03044288|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive~   "
987|NCT03044275|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive with topfilm and a standard adhesive with a topfilm.~   "
988|NCT03044262|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive~   "
989|NCT03044249|"~     A ten-week study to assess MP-101 in the treatment of psychosis in participants with~     Alzheimer's Disease, as compared to placebo.~   "
990|NCT03044236|"~     To examine and compare the effect of a novel stretching technique and traditional stretching~     on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject~     satisfaction in overhead athletes with glenohumeral internal rotation deficits through a~     randomized clinical study.~   "
991|NCT03044223|"~     The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of~     the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory)~     phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and~     whether the severity of sepsis and outcome is associated with distinct monocyte phenotype~     and function.~   "
992|NCT03044210|"~     Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs~     to the family of Nucleotide Excision Repair. It is an autosomal recessive multisystemic~     disorder characterized by mental retardation, microcephaly, severe growth failure with~     lipoatrophia, sensorial impairment, cutaneous photosensitivity, dental decay, enophtalmios.~     The disease is progressive causing severe impairments but there's currently no therapeutics~     for the disease.~      Growth failure, feeding difficulties and lipoatrophia are prognostic keys of CS but~     physiopathology is unknown.~      According to preliminary assays, our goal is to test the hypothesis that cachexia is due to~     hypometabolism. We also want to test the potential link between this basal metabolism~     modification and mitochondrial dysfunction and somatotrope axis, and correlation between the~     basal metabolism degree and global severity of the disease.~   "
993|NCT03044197|"~     Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many~     biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With~     multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of~     increasing the detection of detecting clinically significant prostate cancer (csPCa) while~     decreasing the detection of non-significant PCa. The goals and the objective of this study~     are as follows keeping this in mind.~   "
1023|NCT03043807|"~     To assess the safety of treating men with oligometastatic prostate cancer with the following~     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant~     androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor~     control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to~     oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.~     Androgen blockade will be the same throughout the course of treatment.~   "
1024|NCT03043794|"~     This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk~     breast cancer.~   "
1025|NCT03043781|"~     This study evaluates the use of intermittent epidural boluses compared to continuous~     infusion in maintaining epidural pain relief in labor.~      The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in~     both groups.~   "
994|NCT03044184|"~     This study aims to explore the effectiveness of tranexamic acid (also known as trans amine~     or TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the~     acute phase.~      METHODOLOGY~      This will be a Phase III, parallel-group double-blind randomised placebo control trial.~     Patients allocated to the control group will receive standard care for hemorrhagic stroke~     according to the 2015 American Heart Association guidelines. Patients allocated to the~     intervention group will receive, in addition to standard care, a loading dose of intravenous~     TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.~     Timing and dosing are in accordance to previous established study protocols. Patients in the~     intervention group will only receive a single treatment course of TXA.~      Study subjects will be identified by either the on-duty clinicians from the Department of~     Neurosurgery of this institution or by the study investigators. Should the patient meet~     study eligibility criteria consent will be obtained either from the patient or from his/her~     next of kin. 1:1 block randomization will be performed by a remote internet randomization~     service by accessing a website. Patients allocated to the intervention arm will have 1gm of~     TXA added to 100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This~     is then followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic~     solution infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control~     arm will have an equal volume of normal saline (0.9%) infused as a placebo. The patient and~     the outcome assessor will be blinded to study group allocation.~      The primary endpoint of this study will be to assess the percentage change in brain blood~     clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and~     at 1 week.~   "
995|NCT03044171|"~     To investigate the effects of desensitizing agents on the dental bleaching process, testing~     the hypothesis that they may prevent dental sensitivity.~   "
996|NCT03044158|"~     The study proposes to conduct a pragmatic, parallel cluster-randomized trial with nested~     mixed methods, health economic and modeling studies to evaluate the effectiveness,~     implementation and costs of the intervention strategy relative to standard TB diagnostic~     evaluation at community health centers that are part of Xpert referral networks in Uganda.~     The effectiveness of the intervention strategy will be assessed using routine data collected~     as part of mandatory reporting to the Uganda NTLP on consecutive patients who present to~     participating health centers during the 2-year trial period and meet eligibility criteria.~     Selected patients and providers who provide informed consent will also be surveyed,~     interviewed, and/or participate in focus groups to identify reasons for its success or~     failure across study sites (Aim 2), and to collect relevant cost data for cost-effectiveness~     analyses (Aim 3).~   "
997|NCT03044145|"~     This study consists of two projects:~      Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and~     9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician~     feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by~     reading over the CFI-EA treatment manual and practicing how they can use it in behavioral~     simulations, and then check whether participants think they can do it (feasibility) and like~     it (acceptability) through standard measures. Following this the study team will revise the~     CFI-EA based on their feedback for the comparative open trial in Phase 2.~      Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot~     trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study~     team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment~     manual and practicing how they can use it in behavioral simulations. Then, the study team~     will check whether participants think they can do it (feasibility) and like it~     (acceptability) through standard measures, and in addition will also explore any initial~     effects on communication behaviors among patients and clinicians and treatment engagement~     based on treatment retention.~      The specific aims are:~      For Project 1:~        1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open~          trial that explores communication mechanisms of action in terms of communication~          behavior and cultural content, and~        2. To revise the CFI-EA intervention based on patient and clinician feedback on its~          feasibility and acceptability.~      As real-world community stakeholders for whom the CFI-EA is being developed, patients and~     clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor~     treatment plans around patient cultural views and treatment preferences to keep patients in~     care. The CFI-EA will be revised around areas of maximal agreement among patients and~     clinicians with the help of health disparities and communication experts.~      For Project 2:~        1. To test the revised CFI-EA's feasibility and acceptability among patients and~          clinicians in a pilot open trial against treatment as usual, and~        2. To explore the relationship between the revised CFI-EA's effects on patient-clinician~          communication and treatment engagement.~      The study team hypothesize that clinicians using the revised CFI-EA will show more positive~     communication behaviors compared to clinicians delivering treatment as usual and that CFI-EA~     patients will stay in treatment longer. Communication behaviors will be assessed through~     communication analysis techniques such as the Roter Interaction Analysis System.~   "
998|NCT03044132|"~     This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes~     of DermACELL AWM in dermal regeneration.~   "
999|NCT03044119|"~     The Primary Objectives of the present study are :~        -  To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood~          mesenchymal stem cells (PBMSCs) on implant stability.~        -  To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood~          mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on~          implant stability.~   "
1000|NCT03044106|"~     Purpose: To conduct a pilot study of the effect of Cranial Laser Reflex Technique (CLRT)~     compared with sham laser on hamstring muscle flexibility, strength, and pain pressure~     threshold.~      Participants: Active, young adults ages 18 to 35.~      Procedures: In a single, blinded crossover fashion, subjects will complete three functional~     hamstring tests after CLRT and after sham laser treatment. Subjects will also complete~     questionnaires to assess their expectations and perceptions of the interventions.~   "
1001|NCT03044093|"~     Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion -~     a Double Blinded Randomized Controlled Trial~   "
1002|NCT03044080|"~     Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated~     use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in~     three successive infiltrations at 6-month intervals, checking if the sustainability of the~     effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).~   "
1003|NCT03044067|"~     Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This~     condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a~     female to male ratio of 3:1) over 50 years of age with low education level and low~     socioeconomic status, living in rural areas. High direct medical costs and significant~     indirect costs of this condition can't be ignored.~   "
1004|NCT03044054|"~     This study evaluates the efficacy and the safety of the HIFU for the treatment of breast~     fibroadenoma.~   "
1005|NCT03044041|"~     The purpose of this study is to compare blood loss between using low dose (500 mg) and high~     dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in~     double-blind RCT~   "
1037|NCT03043625|"~     Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in~     the region between the superior nuchal line and the spinal process of the first thoracic~     vertebra, without association with any specific systemic disease provided by multifactorial~     and/or little known causes.~      Objective: The objective of the present study will be to verify the clinical effects of MV~     through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.~      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)~     will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control~     group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and~     liver wile CG received placebo treatment. The immediate effects and 7 days after treatment~     will be evaluated through pain, cervical range, and electromyographic activity of the upper~     trapezius.~   "
1006|NCT03044028|"~     The current standard for rehabilitation after TKA consists of guided exercise therapy for up~     to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The~     surgery and rehabilitation are highly successful at reducing or eliminating pain experienced~     preoperatively. However, QFM strength, overall function, and knee range of motion are often~     worse than preoperative levels for as long as 6 months after surgery and in some cases may~     persist for many years after that. Such quadriceps strength impairments after TKA have been~     largely attributed to voluntary activation deficits and can lead to a decrease in functional~     performance such as decreased gait speed, decreased balance which can lead to falls, and~     decreased stair climbing & chair rise abilities.~      Since therapy alone does not adequately restore or improve upon the preoperative functional~     capabilities in a consistent and timely manner, it has been suggested that NMES used~     adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle~     activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag,~     increase walking speed, and improve QFM strength, knee range of motion, and function.~     However, NMES initiated one month after TKA did not lead to improved QFM strength or~     function beyond the standard benefits gained from exercise alone, thus suggesting that the~     timing of NMES application after TKA is important.~      It has previously been shown that preoperative QFM strength is predictive of postoperative~     function [6] but the benefit of prehabilitation remains in question. To date, there has only~     been one pilot study assessing the benefits of NMES when initiated preoperatively. This~     study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative~     NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important~     to assess the benefits of NMES both preoperatively and postoperatively in order to determine~     how it will be most beneficial to TKA patients.~   "
1007|NCT03044015|"~     BACKGROUND Recent evidence has been published about the effectiveness for the secondary~     prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.~      AIM To assess the effectiveness of a primary care based intervention in the secondary~     prevention of OF.~      METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT)~     level. Total study follow-up 3 years. Sample size 1800 patients.~      DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a~     primary care based intervention about lifestyle, diet and drug prescription, if needed, with~     an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.~      ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will~     be analyzed through Cox proportional hazard regression model stratified by age groups.~      Outcomes :~        -  new OF ratio in intervention vs control areas.~        -  maintenance of the adherence to the pharmacological and non pharmacological~          interventions proposed~        -  assessment of cost-effectivity of the intervention~   "
1008|NCT03044002|"~     Controlled, multicenter, non-inferiority trial to compare the rate of access site~     complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular~     interventions.~   "
1009|NCT03043989|"~     This clinical trial is being conducted to recommend a safe and tolerable phase 2 dose of~     docetaxel or cabazitaxel when combined with clarithromycin in men who have developed~     castrate-resistant prostate cancer.~      In the castrate-resistant setting, resistance to taxane therapy inevitably develops. Men who~     develop resistance to taxanes have a very poor prognosis, and few treatment options.~      It is believed that CYP enzymes contribute to docetaxel and cabazitaxel resistance in~     metastatic prostate cancer, and this resistance can be mitigated through pharmacologic CYP~     inhibition. In this study a potent CYP3A inhibitor, clarithromycin, will be co-administered~     concurrently with either docetaxel or cabazitaxel, whose systemic metabolism is dependent of~     CYP3A4, with the intent to overcome resistance to taxanes.~   "
1010|NCT03043976|"~     This study will collect information about physical activity in patients affected by~     pulmonary hypertension, through a specific device that can be worn on the wrist, and which~     measures daily step count. The purpose of the study is to demonstrate whether providing~     patients with their daily step count can increase their levels of daily activity if they~     have some basic targets to achieve. Investigators also wish to compare the effects of this~     approach in increasing daily physical activity, with the benefit gained when a drug therapy~     for pulmonary hypertension is initiated, in patients that have just been diagnosed.~   "
1011|NCT03043963|"~     The main purpose of this study is to learn about the influence of two different behavioral~     interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study~     the mechanisms involved. There is research evidence that healthy sleep promotes heart-health~     and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may~     be influenced by sex. This research will compare two interventions that are each designed to~     improve sleep health, and will investigate sex differences in response. The project includes~     3 in-hospital stays with biological measurements to evaluate the underlying mechanisms~     associated with the effectiveness of two different blood pressure lowering behavioral~     interventions.~   "
1012|NCT03043950|"~     A safety and efficacy study of first line therapy with Vectibix® in combination with~     irinotecan, 5‑fluorouracil, and folinic acid (FOLFIRI) to validate a prognostic score in~     adult patients with RAS wild-type metastatic colorectal cancer in a real world setting~     (VALIDATE)~   "
1013|NCT03043937|"~     The aim of this work is to demonstrate the variation of cardiac diseases among pregnant~     ladies in our localities, detect maternal & fetal complications and to predict the risk~     factors for poor maternal, fetal & neonatal outcomes~   "
1014|NCT03043924|"~     The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is~     associated with transient microstructural and metabolic changes in the female hypothalamus~     using MRI approaches to assess water diffusion and measure proton magnetic resonance~     spectra.~   "
1015|NCT03043911|"~     The investigator intend to perform an observational study, by adding Respiratory Rate~     monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and~     PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be~     deactivated. Retrospective analysis of the observational data collected will be utilized to~     evaluate the potential benefits of additional continuous respiratory rate monitoring.~   "
1038|NCT03043612|"~     The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to~     reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for~     urolithiasis.~   "
1039|NCT03043599|"~     The purpose of the safety run in Phase I portion of this study is to confirm the recommended~     Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic~     radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard~     treatment with 4-6 cycles of platinum-based chemotherapy.~      The purpose of the Phase II portion of this study is to estimate the 6-month Progression~     Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with~     thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6~     cycles of platinum based chemotherapy.~   "
9353|NCT02934802|"~     This post-market clinical follow-up study intends to investigate the survival rate at 5~     years of the e.motion® PS Pro System.~   "
1016|NCT03043898|"~     This study addresses the question, how does sound propagate from a source in the chest to~     the chest wall? Using sound recorded at the chest as a diagnostic technique has the~     advantage of being non-invasive and non-radioactive, but compared to other techniques it~     cannot currently differentiate well between different diseases. Our aim is to improve our~     ability to differentiate between different diseases using sound recorded at the chest by~     improving our fundamental understanding of mechanisms by which sound propagates through the~     chest.~      Examples of conditions that could be diagnosed using audible lung sounds are bronchomalacia,~     asthma, lung cancer, interstitial lung disease and chronic obstructive pulmonary disease.~     The methodology of the study will be to place a sound source at a known location in the~     chest and measure the acoustic response on the chest wall with a microphone array.~      The sound source will be created by playing sound down the working channel of a bronchoscope~     and located anatomically using direct imaging. By placing a sound source inside the chest we~     will be able to generate an acoustic map of the chest and test the relative importance of~     different propagation mechanisms. This will be an advance on previous work, which placed a~     sound source at the mouth.~      Subjects will be selected for the study by asking patients undergoing a bronchoscopy~     procedure whether they would be willing to take part in the experiment in addition to their~     standard procedure.~      Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge.~     The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease,~     asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally~     significant interventional bronchoscopy service.~      A subsidiary part of the study will collect sound recordings from healthy volunteers and~     patients with common respiratory diseases using the same microphone array. This is to create~     a database of lung sounds and quantify inter-subject variability.~      The study will last approximately 18 months.~   "
1017|NCT03043885|"~     Improved predictability and quality of bone healing after a tooth is removed is clinically~     relevant, in that, it improves our ability to achieve successful implant placement at~     edentulous sites. Currently, a variety of grafting materials and biologic agents are~     utilized clinically to improve bone healing and provide sufficient dimensions of bone to~     support a dental implant. Platelet rich fibrin (PRF) is one such product that can be used~     for this application. PRF is a concentrated blood product attained from the patient's own~     blood consisting of a natural bioscaffold with integrated growth factors capable of~     sustained release. Once processed, PRF is implanted back into the patient at the wound or~     defect site to encourage healing. The literature regarding PRF is currently dominated by~     heterogeneous applications of PRF for reparative and regenerative therapies without a~     consensus of its clinical efficacy and appropriate application. In this clinical study, PRF~     will be evaluated to ascertain its clinical efficacy in improving bone formation and~     alveolar dimensional stability after tooth extraction. A classic bone grafting material used~     for this purpose, freeze dried bone allograft (FDBA), will be incorporated with the PRF or~     compared directly to PRF alone. It is hypothesized that the natural scaffold and~     incorporated growth factors of PRF augmented with the solubility resistance of FDBA will~     function as an ideal bioscaffold to promote bone healing to a greater extent compared to~     PRF, FDBA, or blood clot alone.~   "
1018|NCT03043872|"~     This is a phase III, randomized, open-label, multicenter, global study to determine the~     efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy~     (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line~     treatment in patients with extensive-stage small-cell lung cancer.~   "
1019|NCT03043859|"~     In Canada, there is a growing burden of type 2 diabetes (T2D). Approaches to implement~     nutrition recommendations and promote sustainable eating behaviours are required. The~     investigating research team developed an educational curriculum that includes practical~     information about Eating Well with Canada's Food Guide, portion control and food label~     reading. The research team also developed a cookbook, Pure Prairie Eating Plan which~     translates the Canadian Diabetes Association Clinical Practice Guidelines into a practical~     menu plan with recipes, grocery lists and cooking tips. These resources promote behaviour~     change and skill development to independently manage diabetes. These resources have been~     successfully employed in a clinical study trial conducted at the University of Alberta and~     in a pilot project at the community (Pure Prairie Living Program -PPLP), and showed~     beneficial effects in management of diabetes among participants. The objective of this study~     is to implement and evaluate the PPLP in a community level, to promote healthy lifestyle~     among people with T2D in the general community. To meet the study objective, 60 adult~     participants with diagnosed T2D will be recruited from three different primary care networks~     (total of 180 participants) and at each site 30 participants will be randomized into the~     education intervention (PPLP) and 30 will be the wait-listed controls (CON) receiving usual~     care. PPLP participants will attend 5, biweekly education sessions and a grocery store tour~     scheduled over a period of 3 months.The benefits of the lifestyle intervention on~     physiological indicators (BMI, Haemoglobin A1C, blood lipids, blood pressure) and lifestyle~     choices (adherence to dietary recommendations, self-efficacy and participation in physical~     activity) will be examined.~   "
1020|NCT03043846|"~     This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate~     the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e.~     usual care) in patients with axial spondyloarthritis.~   "
1021|NCT03043833|"~     This study represents Phase II of a research program involving an international~     collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based~     cognitive behavior therapy for the treatment of anxiety and depression in French-speaking~     Canadians from the Atlantic Provinces.~      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided~     format version of the Wellbeing Course by conducting a randomized-control trial where an~     experimental group will be compared to a waitlist control group. A secondary objective is to~     demonstrate the course's acceptability through participants' satisfaction with the course.~   "
1022|NCT03043820|"~     There is increasing clinical and molecular evidence for the role of hormones and~     specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor~     modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition~     in older adults. The present study will test the extent to which adjunctive raloxifene~     treatment improved cognition and reduced symptoms in young to middle-age men and women with~     schizophrenia.~      154 patients with a schizophrenia spectrum disorder will be recruited in a multicenter~     twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive~     120mg raloxifene treatment in addition to their usual antipsychotic medications.~      The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in~     addition to antipsychotic treatment improves cognition, reduces psychotic symptoms,~     increases social and personal functioning and reduces health care costs, as compared to~     placebo.~   "
1056|NCT03043378|"~     The goal of this research study is to learn how frequently cancer patients in the Supportive~     Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is~     neither related to cancer nor its treatment and lasts beyond the normal tissue healing time~     of 3 months.~   "
1026|NCT03043768|"~     In Parkinson's disease (PD), alpha-synuclein accumulation in cutaneous autonomic pilomotor~     and sudomotor nerve fibers has been linked to autonomic nervous system disturbances even in~     the early stages of the disease. The investigators recently introduced a non-invasive~     technique to assess autonomic adrenergic fiber function using the quantitative pilomotor~     axon-reflex test (QPART). In the present study the investigators aim to assess the~     association between alpha-synuclein mediated structural autonomic nerve fiber damage and~     nerve function in PD, elucidate the role of neuropathy progression during the early disease~     stages, and test reproducibility and external validity of pilomotor function assessment~     using quantitative pilomotor axon-reflex test (QPART) and sudomotor function via~     quantitative direct and indirect test of sudomotor function (QDIRT).~      A prospective controlled study will be conducted in four sites (Dresden, Germany; Berlin,~     Germany; Budapest, Hungary; Boston, USA). A total of 52 male and female patients with~     idiopathic PD (Hoehn&Yahr 1-2) and 52 age- and sex-matched healthy controls will be~     recruited. Pilomotor function will be evaluated after iontophoresis of phenylephrine on the~     dorsal forearm to elicit a cutaneous axon-reflex mediated response (goosebumps). Silicone~     impressions of the stimulated area will be obtained, scanned and quantified for pilomotor~     muscle impressions by number, impression size and area of axon-reflex pilomotor erection~     spread. Sudomotor function will be evaluated after axon-reflex stimulation via iontophoresis~     of acetylcholine on the dorsal forearm. Stained sweat droplets will be captured using~     repeated digital photography and will be quantified over time for droplet number and~     axon-reflex spread. Sympathetic skin responses following deep inspiration will be analyzed~     using skin conductance quantification. Testing and evaluation of autonomic and motor~     symptoms will be performed at baseline, after 2 weeks, 1 year, 2 years and 3 years. Skin~     biopsies will be obtained at baseline and after 3 years and will be analyzed for nerve fiber~     density and alpha-synuclein accumulation.~      The investigators expect that this study will unveil whether progression of autonomic nerve~     dysfunction assessed via pilomotor and sudomotor axon-reflex tests is related to progression~     of autonomic symptom severity and alpha-synuclein deposition in PD. Additionally, potential~     applications of the used techniques include interventional studies evaluating~     disease-modifying approaches and clinical assessment of autonomic dysfunction in patients~     with PD.~   "
1027|NCT03043755|"~     Propose to evaluate efficacy of association between US guide parasternal block and pectorals~     nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and~     simple mastectomy).~      All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will~     be observed.~      All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine~     0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.~      During surgery patients receive light sedation with continuous infusion of propofol~      Will be observed:~      Additional local anesthetic infiltration from surgeon. Pain at rest and during movement~     quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.~      Eventual side effects such as nausea/vomiting.~   "
1028|NCT03043742|"~     Assess the safety and effectiveness of stem cell application with regard to improvement in~     regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization~     (TMR) and stem cells.~   "
1029|NCT03043729|"~     Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with~     MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 +~     aflibercept (Arm B) followed by surgery.~   "
1030|NCT03043716|"~     Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and~     maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy~     on long-term outcomes.~   "
1031|NCT03043703|"~     Detecting mild forms of obstructive sleep apnea (OSA) easily and efficiently might help to~     identify and improve care for patients suffering from wake reactions at night. The AirSense~     10 for Her is able to detect respiratory effort related arousals (RERAs) through changes in~     the flow of air. The algorithm of the AirSense 10 will be compared with scoring via~     polysomnography (PSG). 129 patients shall be observed in a sleep facility under suboptimal~     Treatment (i.e. low pressure) with positive airway pressure (PAP) therapy.~   "
1032|NCT03043690|"~     This study is a pooled statistical analysis of the data from 2 studies concerning efficacy~     of ammonium-succinate based dietary supplement. In both studies group 1 took the~     ammonium-succinate based dietary supplement and the group 2 took placebo.~   "
1033|NCT03043677|"~     To characterize circulating DC subsets from healthy controls and IBD patients and to assess,~     following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and~     golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab)~     immunomodulators on both the GI production of soluble immune mediators and the mucosal~     capacity to alter the recruitment capacity of circulating DC subsets. It is expected that~     such approach will provide further information on the action mechanisms of such therapies on~     IBD patients, allowing a better understanding of the pathophysiology of this disease and the~     identification of tissue-specific therapeutic targets, thus avoiding collateral problems~     associated with systemic immunomodulation.~   "
1034|NCT03043664|"~     This study is for patients with non-resectable, recurrent, or metastatic well or moderately~     differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).~      The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort.~        1. Safety run-in: The first stage will include a safety run-in of 6 patients treated with~          pembrolizumab 200 mg intravenous (IV) every 3 weeks and lanreotide depot 90mg~          subcutaneous (SQ) every 3 weeks. Up to 6 patients at the Duke Cancer Institute will be~          accrued at the starting dose level. If one or less subject meets treatment-related~          discontinuation criteria (as specified in the protocol) during Cycle 1, then the study~          will proceed to the second stage, Expanded Cohort.~        2. Expanded Cohort: Patients will be treated with pembrolizumab 200mg IV every 3 weeks and~          lanreotide depot 90mg SQ every 3 weeks as determined by the Safety Run-In Cohort.~   "
1035|NCT03043651|"~     This is an open-label study to evaluate the safety of continued therapy with oral~     treprostinil in subjects who have completed Study TDE-HF-301. This study will provide~     long-term, open-label data regarding the effect of continued long-term oral treprostinil~     therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with~     preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,~     24, and every 12 weeks thereafter until either oral treprostinil becomes commercially~     available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.~   "
1036|NCT03043638|"~     The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP)~     combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in~     the treatment of multiple adjacent gingival recessions (MAGRs).~      12 patients with 84 Miller Class I or II recession defects were participated. Sites were~     randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD),~     recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root~     coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical~     attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months~     postoperatively. The data were analyzed statistically.~   "
1383|NCT03039114|"~     The purpose of this study is to evaluate the safety and efficacy of INCB050465 when combined~     with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular~     lymphoma (FL).~   "
1040|NCT03043586|"~     This is a human, prospective and retrospective, single-center study of patients who have~     undergone treatment for acromegaly in New York City since 1981. The project will~     characterize, among other factors, the treatment methods received by patients, who~     administered the treatments and the success of this therapy in terms of biochemical control.~   "
1041|NCT03043573|"~     The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare~     Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.~     Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,~     affective, and functioning outcomes.~   "
1042|NCT03043560|"~     This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a~     novel treatment target for mood disorders through the administration of the KCNQ-selective~     channel opener ezogabine (Potiga, GlaxoSmithKline; FDA-approved for the treatment of seizure~     disorders).~   "
1043|NCT03043547|"~     is an open label, randomized, multicenter phase II trial~   "
1044|NCT03043534|"~     This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with~     symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will~     be divided into two groups: the Control group of 20 subjects and the Experimental group of~     20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.~      All subjects will use their normal razors and shave products during the six week study. The~     Experimental group of subjects will also be given the study product Pre-Shave Gel and~     Cleansing Brush.~   "
1045|NCT03043521|"~     The purpose of this study is to compare and evaluate impact on pharmacodynamic~     characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male~     volunteers~   "
1046|NCT03043508|"~     OBJECTIVES:~      The primary objective of this study is to evaluate the effect of estrogen on the development~     of the PNET in MEN1 patients.~      The secondary objective is to evaluate the overall survival and disease specific survival in~     patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor~     in relation to their hormone status. The secondary objective is to evaluate~     clinicopathologic features in relation to hormone status.~   "
1047|NCT03043495|"~     A dose-ranging study to test various doses of Dexamethasone (2, 4 & 8 mg) to be used as an~     adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial~     plexus block to find the best balance between valuable effects (mainly duration of analgesic~     Effect) and side-effects (mainly increased random blood sugar levels)~   "
1048|NCT03043482|"~     The purpose of the study is to evaluate the safety, tolerability, and PK following single~     and multiple ascending dose administration of VS-105 in healthy subjects and patients with~     chronic kidney disease stage 5D (CKD-5D) on hemodialysis.~   "
1049|NCT03043469|"~     Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal~     breathing pattern, among other complaints, that can occur either in the absence of other~     pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary~     disease (secondary DB), e.g. asthma. As a consequence, patients may experience~     breathlessness and present with periods of increased ventilation or erratic breathing,~     interspersed with episodes of breath holding or deep sighs. In addition to respiratory~     symptoms, DB also generates non- respiratory symptoms (e.g. dizziness and increased heart~     rate). It is estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB~     remains poorly understood, with no standardised approach to diagnosis and assessment.~      The purposes of this study are:~      Study 1) To identify physiological, functional and psychological characteristics of~     participants with DB compared to healthy participants.~      Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory~     muscle function, respiratory motion, level of physical activity, quality of life and anxiety~     & depression scores will be assessed in 20 participants with primary DB, 20 with secondary~     DB and compared to 20 healthy participants.~      Study 2) To develop an assessment tool based on physiological, functional or psychological~     variables found to be different between any of the 3 groups in Study 1.~      In order to do that, 54 people with DB (between primary and secondary) and 27 people~     presenting with breathlessness secondary to restrictive lung disease will be assessed.~     Analysis of these data will determine whether these variables can be used as a diagnostic~     tool capable of distinguishing DB from restrictive lung diseases characterised by~     breathlessness.~      The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day~     on site testing, plus 7-day home activity monitoring, and 1 day to return the activity~     monitor (which will happen whenever the participant needs to return to the site).~   "
1050|NCT03043456|"~     In this research, the investigators are comparing the new thermoplastic material side by~     side with the conventional poly methyl methacrylate for fully edentulous patients measuring~     their satisfaction and microbiological count.~   "
1051|NCT03043443|"~     A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol~     use disorder and sleep problems will be recruited and assigned randomly to the active~     treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for~     demographics. Sleeping problems will be the primary outcome of the study, and it will be~     measured by the Pittsburgh sleep quality index (PSQI) scale.~   "
1052|NCT03043430|"~     Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric~     patients requiring minor procedures in the Emergency Department setting. Patients will be~     randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam~     0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale~     Preoperative Anxiety Scale (mYPAS).~   "
1053|NCT03043417|"~     This project is measuring the effectiveness of an anti-stigma intervention among primary~     care providers. Both staff and clients will be asked to complete survey data in order to~     measure the effectiveness. This is a randomized control trial in that three health centres~     will receive the intervention and three will not. Results will determine if this~     intervention reduces stigma among staff toward people with a mental health problem and/or~     substance use problem.~   "
1054|NCT03043404|"~     To confirm the acute performance and safety of the Lotus™ Valve Flex System for~     transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific~     aortic stenosis who are considered high risk for surgical valve replacement.~   "
1055|NCT03043391|"~     The purpose of the study is to confirm the optimal dose and potential toxicity of oncolytic~     poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade~     III or IV malignant glioma, but evidence for efficacy will also be sought. The primary~     objective is to confirm the safety of the optimal dose of PVSRIPO when delivered~     intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade~     III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic~     oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant~     glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival~     (OS) in this population.~   "
25643|NCT02721537|"~     Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain~     as measured by 31P MRS?~   "
1057|NCT03043365|"~     Background:~      Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3~     fatty acid is the most known fish oil available in the market. LCMUFA (long-chain~     monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a~     diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched~     fish oil and understand it s effect on cardiovascular health.~      Objective:~      To understand the effects of LCMUFA from fish oil on cardiovascular health.~      Eligibility:~      Healthy volunteers ages 18 and older with no history of cardiovascular disease~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Fasting blood and urine tests~      Optional stool sample~      Questions about their diet, exercise, and the types of medicines and dietary supplements~     they take~      7-day food diary~      Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The heart~     is monitored.~      After the screening visit, participants will take 4 gel capsules, 3 times a day after meals,~     for 8 10 weeks.~      Participants will have 3 additional visits. All include repeats of the screening tests.~      Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for~     8 weeks after this visit.~      Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4~     capsules, 3 times a day after meals, for 8 weeks after this visit.~      Visit 4 is 8 weeks after starting the second supplement.~   "
1058|NCT03043352|"~     HYPOTHESIS:~      Investigators hypothesize that by provision of care at household level in a community~     through lady health workers will as effective (recovery rate, burden of SAM, cost effective,~     coverage) as through health care providers at facility level. OBJECTIVES~        1. To evaluate the effectiveness (rate of recovery, burden & coverage), of SAM standard~          management of children 06-59 months delivered at household level by first level health~          care providers (Lady health workers) compared with the standard CMAM program delivered~          at health facility by Govt./ACF staff.~        2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community~          level versus treatment delivered at health facility by Govt/ACF staff.~      STUDY DESIGN:~      Cluster randomized controlled trial~      SAMPLE SIZE & RANDOMIZATION:~      Investigators took 6% prevalence to calculate the sample size with an expected reduction of~     20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY~     METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute~     malnutrition (SAM) as per the study eligibility criteria (MUAC < 11.5 cm) and manage all~     cases of SAM without complications at home following the national CMAM guidelines. Control~     (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC < 11.5 cm) and will refer~     all cases to the health facility (ACF) for further management and counselling by health~     workers at facility.~   "
1059|NCT03043339|"~     This is a hypothesis-generating pilot study. The intent is to model the impact of~     perioperative practices on the gut microbiome and possibly associate these conditions with~     the final microbiome status (e.g., number of resistance genes and density associated with~     perioperative practices and preoperative microbiome status). Participants will include~     individuals who are having surgery to either receive or donate a kidney. To determine the~     diversity change of the intestinal microbiota over time, rectal swabs will be collected~     before surgery and at several time points after surgery, with the last swab collected 30~     days after surgery.~      The goal of this pilot study is to provide data about gut microbiota diversity in the~     setting of renal transplant surgery, for both kidney recipients and donors. Data from this~     study will guide the design of future clinical trials.~   "
1060|NCT03043326|"~     The purpose of the study is to evaluating the acceptability, use and adherence of a~     pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil~     fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health~     facilities and one community-based organization providing health care services for MSM and~     transgender women.~      This is an Observational, longitudinal, multicenter, open-label study to evaluate the~     acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with~     men and transgender women at substantial high risk of acquiring HIV, who were prescribed for~     PrEP , following the clinical guidelines to prevent HIV infection of the U.S. Centers for~     Disease Control and Prevention (2014) and the World Health Organization (2015).~      Follow-up: Participants will be followed for 96 weeks (approximately two years) after the~     start of prophylactic treatment.~      Implementation Target Population: Adults (≥18 years of age), without HIV infection~     diagnosis, and who were prescribed with PrEP and have a substantial risk of acquiring HIV~     infection according to the international guidelines for HIV prevention.~      Sample Size: 1,000 participants~      Implementation Sites:~        1. Asociación Civil Impacta Salud y Educación, Barranco study site~        2. Asociación Civil Impacta Salud y Educación, San Miguel study site~        3. Asociación Civil Selva Amazónica, ACSA study site~        4. Asociación Vía Libre, Vía Libre study site~        5. Espacio Común, Epicentro study site~      Primary Objectives:~        1. Describing the acceptability and its socio-demographic and sexual behavior correlates~          for the use of PrEP.~        2. Evaluate the persistence of the use of PrEP and its correlates with risk behaviors~        3. Evaluating the adherence to the PrEP using self-reporting and pill counts~      Secondary Objectives:~        1. Describing the changes over time in risky sexual behavior among study participants.~        2. Describing the number of participants who acquire HIV infection.~        3. Evaluate the deviation of the indication of use of PrEP through self- reporting of its~          sale or sharing with third parties.~   "
1061|NCT03043313|"~     This is a phase II trial that will study how well tucatinib (ONT-380) and trastuzumab work~     in treating patients with colorectal cancer with a specific genetic marker (human epidermal~     growth factor receptor 2 - HER2) that has spread to other places in the body or has come~     back and cannot be removed by surgery. Tucatinib has been found to specifically target and~     inhibit HER2.~   "
1062|NCT03043300|"~     This prospective, observational pilot study is designed to assess feasibility, refine the~     target population, and quickly test qualitative and quantitative changes in the microbiome~     after short-term travel to South or Southeast Asia, regions where rates of travelers'~     diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.~      To measure the diversity change of the intestinal microbiota, participants will complete a~     questionnaire and provide a stool specimen at three different time points: prior to~     traveling, two weeks after returning from traveling, and 14 weeks after returning from~     traveling.~   "
1063|NCT03043287|"~     This study is a retrospective chart review of patients treated with onabotulinumtoxinA~     (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE)~     cutoff ratios that predict post-procedure urinary retention requiring catheterization.~   "
1064|NCT03043274|"~     This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI~     in patients with ST-elevation myocardial infarction randomized to receive cangrelor during~     their percutaneous coronary intervention and compares them to patients randomized to not~     receive cangrelor.~   "
1240|NCT03040973|"~     The rollover study will provide continued treatment and assessment of long-term safety~     follow-up in patients receiving capmatinib (INC280) in a Novartis sponsored study and in the~     opinion of the Investigator would benefit from continued treatment.~   "
1065|NCT03043261|"~     EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility,~     usability, effectiveness and relevance of an integrated psycho-behavioral intervention on~     heart failure patients in order to increase support, outreach and general well-being of~     these patients following hospitalization due to heart failure exacerbation.~   "
1066|NCT03043248|"~     This study comprises 2 cohorts, and in each cohort, the study will be conducted as an~     open-label add-on study.~      The purpose of the study is to investigate the pharmacokinetics of each substrate in~     concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort~     A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in~     healthy adult males.~   "
1067|NCT03043235|"~     This research study will examine how ethnic/racial background, body composition (%body fat),~     and the location of body fat affect the ability of the hormone insulin to promote uptake of~     blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in~     promoting blood sugar uptake, this condition is termed insulin resistance. Insulin~     resistance plays a major role in the development of chronic metabolic diseases (such as type~     2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous~     studies suggest that insulin resistance is higher in African-Americans (AA) vs.~     European-Americans (EA). However, results from these studies remain unclear due to different~     testing measures used for insulin resistance as well as differences in body fat between~     individuals. Results from this research study may help explain why insulin resistance~     differs with genetic background and may guide development of personalized treatment~     strategies with implications for several chronic metabolic diseases (e.g., type 2 diabetes,~     cardiovascular disease, and cancer).~   "
1068|NCT03043222|"~     For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues:~     the onset of bothersome urinary symptoms attributable to prostate enlargement and~     diminishing ability to maintain normal sexual activity and function; both issues are~     important to men, yet often the treatment of the former has adverse effects on the latter.~     Current medical and surgical treatments offer symptomatic improvement of urinary symptoms.~     However long recovery times, degradation of sexual function and incontinence may negatively~     affect a patient's QoL.~      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving~     techniques with contrasting mechanisms of action (mechanical decompression vs angiographic~     embolization). Both are minimally invasive, yield relief of urinary symptoms and have~     similar safety profiles. More importantly neither causes degradation of sexual function or~     urinary continence. Although multiple studies are being reported on PUL and PAE alike,~     currently there are no prospective clinical trials comparing these two technologies. We aim~     to prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study~     could have a great impact on patient outcomes in men opting for minimally invasive, sexual~     function sparing treatment options for symptom relief from prostate enlargement.~   "
1069|NCT03043209|"~     Investigators aim to use comparative exome and/or genome sequencing to discover causative~     molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this~     study, investigators have targeted hypertrophic cardiomyopathy.~   "
1070|NCT03043196|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of~     Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic~     Periodontitis (CP) patients.~   "
1071|NCT03043183|"~     This study is a prospective, single-center, randomized controlled trial. The study protocol~     was approved by the Ethics Committee at the First Hospital of Jilin University.The~     perioperation nutritional status will be assessed in gastric cancer patients within ERAS~     protocols.The ERAS patients were randomly divided into perioperational nutrition support~     group and conventional pathway group . Inter-group differences were evaluated for~     nutritional index,clinical recovery index, complications etc.~   "
1072|NCT03043170|"~     Background to the research Patients present to Emergency Departments (ED) with a spectrum of~     illness, many of which are life- threatening. The body has the ability to compensate in the~     early stages when things go wrong so that on the surface patients do not appear as sick as~     they really are. Under-diagnosis of severity of illness leads to under-treatment,~     unnecessary mortality, and unnecessary hospital costs. Earlier diagnosis and consequent~     treatment will result in prudent healthcare, cost-benefit and better patient outcomes.~      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power~     and peripheral pressures gives vital clues to the hidden seriousness of illness and is a~     guide to better management. Few EDs in the world assess such haemodynamics. After evaluating~     a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic~     shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if~     applied across EDs in Wales. However, before we can do that we need to strengthen our~     understanding of haemodynamics, and of relevant protocols and non-invasive devices that help~     us to acquire such information.~      Study Design After ethics and institutional approval is obtained from we will conduct a~     prospective, single-centre, cohort study on 354 adult patients with possible shock~     associated with an acute illness or injury who present to the Emergency Department of the~     University Hospital of Wales, and follow them up for 7 days. 354 is a credible number to~     confirm that the strategy works.~      Written consent will be obtained either from the patient or a relative wherever possible but~     a waiver of consent apply to patients who, because of confusion, unconsciousness or severe~     disability, may be unable to give consent. In these cases, consent will first be sought from~     a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a~     relative as soon as practically possible.~      What you hope to discover~      We expect to discover that:~        -  Uscom variables predict 7-day survival and ICU admission~        -  Uscom variables improve the detection and classification of shock~        -  The LiPS definition can be improved.~        -  The objective definition is better than doctors experience~        -  Patients have a good experience and are satisfied with care~   "
1073|NCT03043157|"~     This is an adaptative study where each participant's rocuronium dose will depend on the~     previous patient's response, being higher if it was not enough and lower if it was more than~     enough.~   "
1074|NCT03043144|"~     Malnutrition is an important complication of advanced kidney disease and impairment in smell~     and taste may affect nutritional status. This study will examine the association between~     impairment in smell and taste and nutritional and functional markers among patients with end~     stage renal disease, as well as risk factors for smell and taste impairment.~   "
1086|NCT03042988|"~     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low~     blood pressure on standing), and at least half of them also have high blood pressure while~     lying down (supine hypertension). Exposure to heat, such as in hot environments, often~     worsens their orthostatic hypotension. The causes of this are not fully understood. The~     purpose of this study is to evaluate whether applying local heat over the abdomen of~     patients with autonomic failure and supine hypertension during the night would decrease~     their nocturnal high blood pressure while lying down. This will help us better understand~     the mechanisms underlying this phenomenon, and may be of use in the treatment of supine~     hypertension.~   "
1075|NCT03043131|"~     Metabolic acidosis is a frequent problem in cardiopulmonary bypass. The cause is poorly~     understood, but it appears to be multifactorial. It is assumed to be result of hypoperfusion~     with resultant lactatemia. And other theories include bicarbonate dilution to excessive~     proton activity and diluting fluid.The main three contributors for the development of~     metabolic acidosis are stress of anaesthesia, surgery and Cardio Pulmonary Bypass(CPB)~     prime.Even after research discussion and debate, there is no agreement upon ideal prime.The~     literature is extensive, comparing different types of colloids, colloids versus~     crystalloids, synthetic versus organic, and inclusion of numerous additions in an attempt to~     make a grossly unphysiological state the least disruptive to the body as possible~   "
1076|NCT03043118|"~     Studies have shown that when exposed to a variety of food and flavor options people tend to~     consume more than when only one item is presented. This strategy has been used to increase~     vegetable intake in adults and during snacktime in children. Increasing vegetable~     consumption in children is important because higher vegetable intake has been associated~     with reduced risk of disease and because vegetables can help prevent weight gain by lowering~     the energy density of a meal. The purpose of this study was to investigate the effects of~     using herb and spice blends to create flavor variety in carrots as a model vegetable in a~     laboratory test meal. We predict that children will consume more vegetables and that the~     energy density of the meal will be lower when a variety of seasoned carrots are presented in~     comparison to a single flavor. A secondary goal of the study was to determine other~     influences that may predict children's liking and intake of seasoned vegetables, such as~     previous exposure, infant feeding practices, and genetic bitter sensitivity.~   "
1077|NCT03043105|"~     To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP~     regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.~   "
1078|NCT03043092|"~     Transcranial Doppler ultrasound is bedside tool use to assess cerebral blood perfusion in~     critically ill patients. We sought to conduct a prospective, single centre study aiming to~     determine whether chronic vascular diseases may be a confounder in transcranial Doppler~     ultrasound assessment in critically ill patients.~   "
1079|NCT03043079|"~     Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess~     ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using~     shear wave velocity values measured with ultrasound will identify features of the abdominal~     wall that differ between healthy volunteers and subjects scheduled to have ventral hernia~     repair. Through the use of ultrasound including shear wave velocity measurements, the~     abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to~     those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia~     affects abdominal wall elasticity and effect surgical outcomes.~   "
1080|NCT03043066|"~     To compare the effect of non-surgical periodontal therapy with or without systemic~     administration of amoxicillin and metronidazole on the concentration of serum levels of~     TRAP-5b in patients with generalized chronic periodontitis.~   "
1081|NCT03043053|"~     This is a randomized, double blind, placebo-controlled study of the effects of intranasal~     oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of~     intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study~     visits include screening to determine eligibility, a 2-part baseline visit, and visits every~     2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose~     of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine~     assessments.~   "
1082|NCT03043040|"~     This is a multicenter controlled intervention study that aims to assess the efficacy of a~     telephone follow-up program for the prevention of suicidal behavior in adults discharged~     from general hospitals after a suicide attempt.~      The hypothesis is that the implementation of this program is associated with reduced rates~     of suicide reattempts in these patients and also with delayed reattempts in them.~   "
1083|NCT03043027|"~     Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper~     urinary tract calculus disease. Despite being minimally invasive, it is associated with~     significant postoperative pain, often necessitating inpatient hospitalization and narcotic~     pain medications. Additionally, one of a number of catheters is often left protruding from~     the access tract for a period of time following the procedure, adding to patient discomfort.~     Attempts have been made to study peri-tubular or access tract analgesic installation, which~     have shown promise.1-2 However, no studies, to our knowledge, have examined the use of~     liposomal bupivacaine preparations in this regard. In this study we hope to prospectively~     analyze the use of liposomal bupivacaine injected to the access tract site at the time of~     PCNL and determine its effects on postoperative narcotic requirement and pain scores.~      Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual~     care, which involves no injection of local anesthesia. Patients will then be followed during~     their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using~     Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge~     criteria will not change during the course of this study.~   "
1084|NCT03043014|"~     Surgical abortion is one of the most frequently surgery of women in the world. 43 millions~     are annually performed in the world.~      90% of the abortions are performed during the first trimester of pregnancy before 13 weeks.~     Legal surgical abortion during the first trimester of pregnancy is a low risk intervention~     with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3~     % to 3.4 %.~   "
1085|NCT03043001|"~     Since memantine may not only inhibit overactivity of microglial cell, but also repair the~     damaged neurons and neurogenesis through activation of astroglial cell and release of~     neurotrophic factors, the investigators propose that the neurotrophic effect of memantine~     may benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol~     dependence. In the current study, the investigator will investigate whether add-on memantine~     at a dose of 5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.~   "
1139|NCT03042299|"~     The purpose of this study is to evaluate the bio-equivalence of a single oral administration~     of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial~     formulation in Japanese healthy adult male participants in an open label, 2-period,~     2-treatment, cross-over design.~   "
28797|NCT02680184|"~     A Multicenter, Open-Label, Phase 1b Clinical Study of CMP-001 in Combination with~     Pembrolizumab in Subjects with Advanced Melanoma~   "
1087|NCT03042975|"~     The contribution of genetic risk factors to the development of focal dystonias is evident.~     However, understanding of how variations in the causative gene expression lead to variations~     in brain abnormalities in different phenotypes of dystonia (e.g., familial, sporadic)~     remains limited. The research program of the investigators is set to determine the~     relationship between brain changes and genetic risk factors in spasmodic dysphonia (or~     laryngeal dystonia). The researchers use a novel approach of combined imaging genetics,~     next-generation DNA sequencing, and clinico-behavioral neurotesting. The use of a~     cross-disciplinary approach as a tool for discovery of the mediating neural mechanisms that~     bridge the gap from DNA sequence to pathophysiology of dystonia holds a promise for the~     understanding of the mechanistic aspects of brain function affected by risk gene variants,~     which can be used reliably for discovery of associated genes and neural integrity markers~     for this disorder. The expected outcome of this study may lead to better clinical management~     of this disorder, including its improved detection, accurate diagnosis, and assessment of~     the risk to develop spasmodic dysphonia in family members.~   "
1088|NCT03042962|"~     Task-specific focal dystonias are characterized by selective activation of dystonic~     movements during performance of highly learned motor tasks, such as writing or playing a~     musical instrument. To date, there is only limited knowledge about the distinct neural~     abnormalities that lead to the development of task-specificity in focal dystonias, which~     affect similar muscle groups but result in different clinical manifestations, such as~     writer's cramp vs. pianist's dystonia or spasmodic dysphonia vs. singer's dystonia. Our goal~     is to dissect the pathophysiological mechanisms underlying the phenomenon of task~     specificity in isolated focal dystonias using multi-level brain network analysis in~     conjunction with neuropathological examination of postmortem brain tissue from patients with~     dystonia. Rather than viewing these disorders as interesting curiosities, understanding the~     biology of task-specific activation of motor programs is central to understanding dystonia.~   "
1089|NCT03042949|"~     An assesment of an optical system that measures blood pressure on the finger -Elfor 1~     device. The system is based on a small optical sensor that emits coherent light into the~     skin and collects the reflected light from the red blood cells in the blood vessels in the~     skin under the sensor. The sensor is able to detect the pulse wave and blood pressure can be~     measured.~      The investigators plan to measure blood pressure with the new sensor in patients who are~     attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to~     validate the sensor.~   "
1090|NCT03042936|"~     The purpose of this study is to test the effectiveness of an out-of-school diabetes~     prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2~     diabetes.~   "
1091|NCT03042923|"~     The objective of this project will be to determine whether patients with a surgical~     diagnosis of endometriosis have impaired intestinal permeability as compared with healthy~     controls. This would suggest the presence of an environmentally triggered and intestinally~     mediated association in the etiology of endometriosis. This would be a proof of concept~     trial to establish whether there is in fact a relationship worthy of future research.~   "
1092|NCT03042910|"~     This study is designed to evaluate the effects of talazoparib on cardiac repolarization in~     patients with advanced solid tumors with no available standard treatment options.~   "
1093|NCT03042897|"~     This pilot clinical trial studies exercise and diet intervention in promoting weight loss in~     obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and~     minimize the risk of gynecologic surgery related to being overweight in patients with~     endometrial cancer.~   "
1094|NCT03042884|"~     The goal of this research study is to learn how useful a wearable exercise tracker watch is~     to monitor participant's physical activity and learn if it can help to increase~     participant's physical activity.~   "
1095|NCT03042871|"~     The purpose of this study is to compare the efficacy (times of injection, change of visual~     acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different~     dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological~     myopia choroidal neovascularization (PM-CNV).~   "
1096|NCT03042858|"~     This will be a multi-center prospective observational study of all patients who undergo~     laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their~     18th birthday through annual phone calls or emails to determine the incidence and timing of~     subsequent inguinal hernia.~   "
1097|NCT03042845|"~     The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo~     Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co)~     catheters, in coronary angiography via the right transradial route. This is a prospective,~     randomized, study of parallel design. Consecutive patients with acute coronary syndrome~     (ACS), eligible for non-urgent coronary angiography, are randomized after successful~     cannulation of right radial artery and informed consent to either Tigger II or Judkins~     3.5L/4R catheters.~   "
1098|NCT03042832|"~     This study will test the effects of the Leadership and Organizational Change for~     Implementation (LOCI) intervention in facilitating evidence-based practice (EBP)~     implementation in substance use disorder (SUD) and HIV services settings. LOCI improves~     implementation leadership and organizational support to develop strategic climate for EBP~     implementation. Greater efficiency and effectiveness of EBP implementation will improve the~     public health impact of evidence-based health and allied healthcare innovations and lead to~     greater effectiveness of SUD and HIV services.~      Project Terms:~   "
1099|NCT03042819|"~     This is a phase 1b study of investigational drug selinexor in combination with doxorubicin~     in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this~     study is to determine how safe and tolerable the combination is, as well as the best dose of~     the study drugs in this patient population.~      Selinexor (also called KPT-330), works by trapping tumor suppressor proteins within the~     cell and thus causing the cancer cells to die or stop growing.~   "
1158|NCT03042052|"~     Aims of this study were to assess the long-term outcomes of detrusor injection of~     OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization~     (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk~     factors for failure.~   "
1447|NCT03038269|"~     The purpose of this study is to improve arm function in adults with hemiplegic cerebral~     palsy. Participants will receive transcranial direct current stimulation (or sham) in~     combination with upper extremity robotic therapy.~   "
1100|NCT03042806|"~     Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary~     rehabilitation in terms of exercise capacity, symptoms and health-related quality of life~     whereas the effect on physical activity is still not clear. Some studies have investigated~     the effect of exercise training on daily physical activity. However, there is considerable~     variability in study findings, data are discordant and the effect of exercise training on~     physical activity is unclear. There are probably a number of reasons to account for this.~      First of all, the choice of the method for evaluating physical activity. Although direct~     observation, double-labelled water and calorimetry are considered the gold standard for~     assessing physical activity, they are too time consuming and expensive to be used in large~     population studies .The Physical Activity (PA) of patients with COPD can be assessed using~     questionnaires. A variety of questionnaires exist that capture different aspects of physical~     activity such as amount, type, intensity, symptom experience and limitations in the~     performance of ''activities of daily life''. Up to now, it still does not exist an~     instrument that evaluates the physical activity of COPD patients in Italian language that~     takes in account Italian people' lifestyle. Since this is strongly influenced by the~     environment, cultural and social conditions in which we live, it is essential to have an~     instrument specifically tailored for the population under study.~      Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in~     COPD patients pointing to assess self-perceived physical activity.~   "
1101|NCT03042793|"~     Title: Vaccination with PD-L1 peptide with Montanide against multiple myeloma after high~     dose chemotherapy with stem cell support. A phase I first-in-human study.~      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy~     targeting the immune checkpoint molecule PD-L1 to investigate the potential of vaccination~     against PD-L1 as a possible anticancer target.~   "
1102|NCT03042780|"~     The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with~     gastroenteropancreatic high-grade neuroendocrine carcinomas.~      This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high~     grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus~     beyond first-line).~   "
1103|NCT03042767|"~     The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in~     children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care~     treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT).~     Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in~     treatment compared to placebo.~   "
1104|NCT03042754|"~     Early diagnosis can contribute to good treatment outcomes and isolate infection control.~   "
1105|NCT03042741|"~     Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical~     trials. It has shown significant improvement in lipid profile in patients with overweight or~     obesity~   "
1106|NCT03042728|"~     In this study the investigators hypothesize that the presence of a dog will provide~     additional benefits above typical therapy for patients suffering from fibromyalgia.~   "
1107|NCT03042715|"~     This research study is evaluating a psychological intervention for caregivers of patients~     undergoing stem cell transplantation.~      Phase 1 will include a qualitative phase to refine the intervention to specifically target~     the needs of caregivers~      Phase 2 of the trial will transition to an interventional randomization clinical trial~   "
1108|NCT03042702|"~     Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an~     anti-proliferative p53 activator pharmacological class, for the treatment of cancer.~     Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild~     type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.~      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be~     evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to~     evaluate the pharmacokinetics of Kevetrin when administered to subjects with~     platinum-resistant/refractory ovarian cancer.~   "
1109|NCT03042689|"~     This research study is studying a drug as a possible treatment for advanced myeloid~     malignancies including AML (acute myeloid leukemia), MDS (myelodysplastic syndrome) and MPN~     (myeloproliferative neoplasms)~      The intervention involved in this study is:~      -Regorafenib (Stivarga)~   "
1110|NCT03042676|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of~     acute leukemias. The most important post-transplant complication is graft vs host disease~     (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin~     (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any~     increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number,~     NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease~     in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of~     ATG (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the~     setting of acute leukemias in any remission, receiving peripheral blood stem cells from an~     HLA identical sibling donor after myeloablative preparative regimen. In particular, the GVHD~     extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a~     minimum follow up of 2 years from transplant. The investigators would like to evaluate the~     longer term follow up of this study.~   "
1111|NCT03042663|"~     To evaluate the value of US-guided Stellate ganglion block for improving radial arterial~     blood flow and peripheral perfusion in Septic shock patients on vasopressor support with an~     indwelling radial arterial cannula, which can result in reduced incidence premature failure~     of the catheter (due to vasospasm or thrombosis) and incidence of ischemic complications in~     the cannulated arm.~   "
1112|NCT03042650|"~     The purpose of this study is to determine if Intensive Referral Intervention increases~     motivation to quit cigarette smoking and quitting-related behaviors in probationers and also~     to determine if Intensive Referral Intervention improves short-term substance use outcomes~     in probationers with substance use disorder.~   "
1113|NCT03042637|"~     The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem~     for investigators in part because of the wide array of pathogenic mechanisms that contribute~     to these disorders as well as the lack of adequately powered, controlled trials. While~     glucocorticoids remain the primary therapy for many forms of protein uric glomerular~     diseases, prolonged use is associated with significant morbidities including steroid induced~     diabetes, metabolic bone disease, and excessive weight gain.~   "
1114|NCT03042624|"~     This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of~     atopic dermatitis (AD).~      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,~     Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to~     the list of microorganisms with qualified presumption of safety compiled by the European~     Food Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in~     accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic~     polymerase chain reaction.~      Using a repeated-measure cohort design, the investigators have recently shown that the~     administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was~     associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.~      The present randomized, double-blind, controlled trial is aimed at testing whether the~     fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing~     SCORAD in children with moderate to severe AD using placebo as comparator.~   "
1115|NCT03042611|"~     The purpose of this study is to evaluate the clinical benefit and safety of Apatinib plus~     Best Supportive Care in comparison to Placebo plus Best Supportive Care in patients with~     advanced or metastatic gastric cancer~   "
1116|NCT03042598|"~     Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves~     patient safety (avoiding hypoxia) during emergency rapid sequence intubation .~   "
1117|NCT03042585|"~     Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an~     autologous transplant are likely to suffer a relapse because standard myeloablative~     preparative regimens are unable to produce a cure. The majority of these participants do not~     have a stem cell donor available, are too frail to undergo an allogeneic transplant, or~     refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma~     have had a very poor outcome.~      To take advantage of the low transplant related mortality associated with an autologous~     transplantation, the investigators propose modifying the preparative regimen to make it more~     effective without increasing toxicity. By increasing the dose of radiation while~     administering the protective growth factor palifermin (Kepivance), the investigators hope to~     decrease the risk of relapse without increasing transplant related mortality.~      Three prospective randomized trials have studied different radiation schemes as a part of~     the TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients~     with AML or CML. As a group these trials showed that higher doses of TBI in these older~     studies decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three~     retrospective studies have also postulated that higher dose radiation led to less risk of~     relapse.~   "
1118|NCT03042572|"~     The primary objective of this trial is to investigate whether intramuscular administration~     of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as~     a composite outcome of mortality, limb status, clinical status (Rutherford classification)~     and pain score (visual analogue scale), in patients with no-option severe limb ischemia~     (SLI).~      The investigators will conduct a double-blind, placebo-controlled randomized clinical trial~     to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI,~     who are not eligible for conventional surgical or endovascular therapies. The investigators~     intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections~     with either BM-MSC (30 injection sites with 5*10^6 MSCs each) or placebo in the lower leg of~     the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome~     considering mortality, limb status, clinical status (Rutherford classification) and changes~     in pain score, will be assessed at six months.~   "
1119|NCT03042559|"~     To compare the effect of Protonics knee brace and Hamstring Resisted Exercise (HRE) on~     anterior pelvic tilt, hip internal rotation and adduction, and knee pain in subjects with~     Patellofemoral pain symptoms (PFPS) and examine the reliability and validity of self-report~     patellofemoral disability index (PDI) as a measure of functional performance in subjects~     with PFPS.~   "
1120|NCT03042546|"~     Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing~     in these sub-segmental bone defects.~   "
1121|NCT03042533|"~     The investigators will compare the three methods of seating a tibial nail - Backslapping or~     Backslapping with Dynamic Locking or Internal Compression.~   "
1122|NCT03042520|"~     Primary Objective:~      To evaluate the long-term outcomes including liver related morbidity, mortality and~     hepatocellular carcinoma (HCC) development as compared to those of historical control with~     interferon(IFN)-based treatment.~      Secondary Objective:~        1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based~          treatment.~        2. To investigate the long-term outcomes of extrahepatic manifestations of the~          sofosbuvir-based treated cohort as compared to their pretreatment status.~   "
1123|NCT03042507|"~     Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention~     for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to~     psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS~     or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group~     now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of~     the CBIT protocol for use across a broader range of ages and treatment settings.~      The goal of the this project is to develop a downward extension of the CBIT therapist guide~     and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR~     manual/workbook will be pilot tested in five children at each of the three study sites~     (UCLA, UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility~     and acceptability as well as our ability to implement the new intervention, along with~     relevant quality control procedures, consistently across sites. These pilot data will then~     be used to seek R01 support for a larger controlled multisite trial examining the efficacy~     of CBIT-JR.~      Although arguably more complex than a single-site design, we have opted for a multsite study~     in order: 1) to take advantage of the established productive collaborative relationship and~     collective expertise in childhood tic disorders and psychosocial treatment development~     across our three sites, 2) to collect the proposed feasibility data in a much shorter period~     of time than otherwise possible, and as noted above 3) to demonstrate the cross-site~     portability of the treatment - which will be necessary if we are to obtain subsequent~     funding for a larger-scale efficacy trial.~   "
10096|NCT02925104|"~     Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food~     in patients with cMET dysregulated advanced solid tumors.~   "
1124|NCT03042494|"~     In recent years, the importance of the gut microbiota to human health has been demonstrated.~     In adulthood, the microbial profile is relatively stable, yet can be transiently altered by~     factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut~     microbiota has been shown to differ in normal versus disease states including inflammatory~     bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,~     there is intense interest in designing interventions that positively influence the gut~     microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides~     that alter the colonic environment in favour of health-promoting bacterial species, such as~     bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to~     beneficially alter the microbial profile, there is a need to identify the dosing~     requirements to positively modulate the gut microbiota. This study will test the effect of~     two doses of prebiotic on gut microbiota taxonomy and diversity.~   "
1125|NCT03042481|"~     Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF)~     are current recommended first-line antiviral therapies for chronic hepatitis B (CHB).~     Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of~     having a potent antiviral effect, and good tolerance without side effect. The long-term~     safety and efficacy of ETV and TDF therapy had also been identified. However, poor~     durability of the effectiveness after stopping NUC therapy are encountered in the majority~     of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg-~     positive CHB patients treated with lamivudine. A recent study investigating the~     post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB~     patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is~     another recommended first line NUC with high potency and high genetic barrier. Although the~     efficacy of long-term TDF therapy had been identified, there is lack of data regarding the~     off-therapy response in CHB patients with TDF therapy currently. Only a small scale of~     patients treated with TDF were included in a recent study investigating off-therapy relapse~     in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In~     addition, the factors associated with off-therapy response are also still uncertain.~      The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy~     ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria~     of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse~     including virological and clinical relapse in all and between patients with ETV and TDF~     therapy, and to identify the predictive factors of relapse.~   "
1126|NCT03042468|"~     The purpose of this study is to find the highest dose level of the study drug,~     177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.~   "
1127|NCT03042455|"~     This study was designed to establish the clinical evidence for effect of Robot-Assisted~     upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function~     of subacute stroke patients.~        -  Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive~          Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to~          conventional occupational therapy~        -  Subjects : total 99 patients with stroke whose upper limb functions are impaired~        -  Intervention : 4 weeks of therapy (5 days per week)~        -  Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion~          analysis~        -  Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks~          of intervention, 4) 4 weeks after end of intervention~   "
1128|NCT03042442|"~     The purpose of this study is to determine the interrelationship between cachexia, neural~     invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to~     identify the protein expression levels of Activin and Midkine in plasma of patients with~     different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate~     the possible correlation with diabetes, tumor size and tumor stage.~   "
1129|NCT03042429|"~     Improvement of event free survival of high-risk neuroblastoma patients by introduction of~     two additional topotecan containing chemotherapy cycles into the multimodal standard~     treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated,~     and consolidation therapy).~   "
1130|NCT03042416|"~     Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific~     patient populations:~        1. Pediatric patients with congenital hyperinsulinism~        2. Pediatric patients with neuroblastoma~        3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor~        4. Adult patients with a clinical suspicion of Parkinson's disease~        5. Pediatric or Adult patients with primary brain tumors~      This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton~     PET Centre.~   "
1131|NCT03042403|"~     This study aims to Analyze and compere the hemodynamic and respiratory variables before,~     during and after the applying of technic as well as evaluate respiratory pressures generated~     during applying of this same technic and correlate them with the effort noticed by device~     user.~   "
1132|NCT03042390|"~     This is a retrospective observational study of patients who have taken a regimen containing~     DRV / c at least 24 weeks prior to study initiation~   "
1133|NCT03042377|"~     The purpose of this randomized clinical trial was to evaluate the incidence of postoperative~     pain after retreatment using different techniques. Patients whom need retreatment were~     included. The presence of postoperative pain was assessed after retreatment cases at 1, 6,~     12, 24 and 48 hrs.~   "
1134|NCT03042364|"~     This study investigates the impact of endometrial scratching on endometrial secretion, when~     correlated to pregnancy.~   "
1135|NCT03042351|"~     Non invasive study to improve the urinary incontinence, through pelvic floor muscles~     exercises~   "
1136|NCT03042338|"~     Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current~     project is to develop and assess the feasibility, acceptability, engagement, and usability~     of a novel, central executive (CE) working memory training intervention.~   "
1137|NCT03042325|"~     The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when~     given as monotherapy or add on therapy in participants who are on standard care for~     management of Type 2 Diabetes Mellitus (T2DM).~   "
1138|NCT03042312|"~     Studies will assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic~     castration resistant prostate cancer.~   "
1140|NCT03042286|"~     To find out the pharmacokinetic and genetic risk factors involved in muscular side effects~     (myalgia) associated with statin therapy. To learn better ways of identifying risk factors~     associated with muscle side effects during statin therapy. To perform laboratory analysis to~     identify factors predicting future outcomes. The genetic material, in combination with other~     medical information and blood tests, will be available to researchers studying genetic and~     other factors that contribute to myalgia caused in some patient population on statin~     medication.~      Patients on statin are selected for this study. This study will recruit 1500 subjects from~     National heart Centre Singapore over a period of 2.5 years.~      Participation in the full study includes the donation of genetic material. However, subjects~     have the option of not having blood subjected to genetic analysis and still participate in~     the study. In this case, blood samples will only be analyzed for the statin drug content.~   "
1141|NCT03042273|"~     This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind,~     parallel-arm study to evaluate the efficacy and safety of High Strength Cranberry (500mg~     Pacran®) in preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).~   "
1142|NCT03042260|"~     The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective~     in preventing serious infectious complications (those that require hospitalization or lead~     to death) in patients with lupus erythematosus that receive intermediate or high dose~     steroids.~   "
1143|NCT03042247|"~     According to the most recent guidelines, total-body imaging techniques are an indispensable~     element in the staging and post-treatment re-evaluation in patients with lymphoma.~     Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the~     gold-standard for the assessment of the disease in these patients. The use of alternative~     methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a~     valid alternative; this would result an advantage, considering the young age of the majority~     of patients at diagnosis and the need to undergo to serial assessments. The recent~     introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate~     morphological information with the high resolution of MRI with the metabolic activity of~     PET, through the uptake of FDG, for a more accurate definition of the extent of disease in~     patients with lymphoma.~   "
1144|NCT03042234|"~     According to the literature, high-intensity interval training (HIIT) emerges as a potential~     training strategy capable of promoting positive adaptations to the health of obese children~     and adolescents, as it demands less execution time (less volume) and can be considered~     motivationally, More attractive to this audience. However, few studies have adopted the~     anaerobic threshold concept and high intensity interval cardiorespiratory training to~     evaluate the oxidation of energetic substrates during and after physical activity in obese~     adolescents with and without insulin resistance.~      In this context, this study aims to analyze the effects of high intensity interval training~     on lipid and glycemic profile, cardiorespiratory parameters, metabolism of substrates, and~     functional capacity of obese adolescents with and without insulin resistance.~   "
1145|NCT03042221|"~     A comparison of baseline tumor characteristics in EGFR mutant lung cancers to tumor~     characteristics after early response of EGFR-TKI targeted treatment to allow identification~     of early adaptive mechanisms of cell survival in the setting of oncogene-targeted therapy.~     This identification will facilitate targeting and termination of these survival/resistance~     pathways before they develop with rational combination of therapeutic agents to improve~     outcomes.~   "
1146|NCT03042208|"~     Research suggests that when one spouse loses weight, the other spouse does too. This study~     will examine whether a ripple effect is observed in untreated spouses and children of~     individuals participating in a nationally available weight loss program. Participants will~     be randomly assigned to either receive Weight Watchers immediately or at the end of a~     6-month waiting period. Participants and untreated spouses (and any children in the home)~     will be assessed at baseline, 3, and 6 months.~   "
1147|NCT03042195|"~     The purpose of the study is to examine whether postoperative nutrition with endeavours of~     100% coverage of the patient's estimated energy and protein needs, can reduce the incidence~     of postoperative complications.~   "
1148|NCT03042182|"~     Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells~     lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer,~     after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile~     duct cancer each year. One-year survival is less than 25% and no effective and safe systemic~     treatments are currently available. Last year the completion of open-label phase 2 trial~     (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that~     two-third of Mongolian patients with advanced HCC had a favorable clinical response,~     including complete remissions and with overall survival over 90% after 1 year. So far a few~     patients with CCA were treated with V5, but it appeared that their response rate was~     somewhat inferior to patients with HCC since two (both with hemochromatosis) out six~     patients died within 6 months. In one patient who had improved clinically, the improvement~     was correlated with decrease in CA19-9 tumor marker, but no marker profile information is~     available in regard to other CCA patients. As V5 tablets are made from pooled blood of~     patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of~     this project is to manufacture an immunotherapeutic formulation made from pooled heat- and~     chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20~     cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the~     National Cancer Center.~   "
1167|NCT03041935|"~     Surgical intervention to treat undescended testis is a very common pediatric surgical~     procedure, often performed using an inguinal incision or subscrotal incision approach.~     Children who undergo orchiopexy can suffer from a significant degree of discomfort~     postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided~     caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve~     block in achieving post operative analgesia following a orchiopexy repair. It is~     hypothesized that US guided IIG/IHG nerve block leads to more effective pain control~     post-operatively while in hospital relative to an US guided CE block for orchiopexy surgery.~   "
1168|NCT03041922|"~     Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting~     positions by using ultrasound device. the elasticity of fat and muscle tissues will be~     measured.~      May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to~     continuous sitting.~   "
1149|NCT03042169|"~     Due to the late onset of symptoms, gastric cancer is frequently diagnosed at an advanced~     stage and therefore in an incurable situation.~      Standard treatment for these patients is palliative chemotherapy, combining 2 or 3 drugs~     (Wagner et al) However chemotherapy efficacy remains insufficient, while exposing patients~     to severe toxicity.~      Taking into account the low complication rates of gastric surgery today, chemotherapy alone~     therefore may not be sufficient for stage IV gastric cancer patients.~      The purpose of palliative gastrectomy is to relieve the symptoms associated with cancer, to~     prevent subsequent tumour complications which are likely to occur, and to improve quality of~     life. In addition reducing the tumour burden, may be associated with a prolonged survival~     time.~      This study is designed as a multicentre trial. Patients with diagnosis of a primary stage IV~     gastric adenocarcinoma who are willing to participate in the trial will be randomized to the~     surgical (gastric resection with peri-operative chemotherapy) or the control (chemotherapy~     only) group.~      Primary objective will be overall survival and secondary objectives will be quality of life,~     progression free survival, surgical related postoperative morbidity and mortality,~     chemotherapy related toxicities, overall duration of hospitalization and number of~     interventional palliative procedures~   "
1150|NCT03042156|"~     Immunotherapy includes a class of medication called checkpoint inhibitors, which are a~     relatively new medication therapy for many types of cancer which are metastatic, meaning it~     has spread to other parts of the body.Immune therapy medication may be given safely with~     radiation treatment, and in rare cases it may even make radiotherapy more effective. When~     radiation therapy is given in the palliative setting it is given to treat pain/discomfort~     and not necessarily shrink or get rid of the tumour. Palliative radiotherapy may be given~     for many reasons, but common examples include painful bone or liver tumours, brain~     metastases, or symptoms from a chest tumour such as feeling breathless, cough, or bleeding.~     Palliative radiotherapy is usually given in smaller amounts and less frequently than other~     types of radiation therapy. Because checkpoint inhibitors are relatively new there is not a~     huge amount of evidence looking at how patients respond when the treatments are combined, or~     in which patients immune therapy may make radiation therapy even more effective. This study~     is looking at the way patients who are on or about to start immune therapy and who have been~     recommended for palliative radiotherapy, respond to the combination of these two treatments.~      The purpose of this study is to describe the treatment outcomes in patients with cancer that~     has spread who are managed with a combination of immune therapy medication and radiotherapy.~     This research is being done because there is limited information about the outcomes of~     combined immune therapy and radiotherapy treatment from a patient's perspective, but also in~     terms of which patients may have a better response to combined treatment. In particular, the~     study aims to describe how combined treatment affects cancer not only in the area where~     radiotherapy is given, but also outside the part of the body that receives radiotherapy~     (which is called abscopal effect).~   "
1151|NCT03042143|"~     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of~     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive~     Care Units and is associated with a high mortality and a high morbidity in those who~     survive. There is a large economic burden with direct healthcare costs, but also indirectly~     due to the impact on the carer and patient through the patients inability to return to full~     time employment. There is little evidence for effective drug (pharmacological) treatment for~     ARDS. There is increasing information that mesenchymal stem cells (MSCs) might be important~     in treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the~     treatment of ARDS. The first step will be to first of all determine what dose of MSCs is~     safe and then divide patients suffering from ARDS into two groups, one of which will get~     MSCs and the other a harmless dummy (or placebo) infusion, who will then be followed up to~     determine if lung function improves. If effective this may lead to further research to~     determine if MSCs are effective in patients with ARDS. This project will also provide new~     information about mechanisms in the development of ARDS leading, potentially, to other new~     treatments~   "
1152|NCT03042130|"~     Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be~     randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The~     control group will receive standard of care alone. The study will test for the effects of~     the additional IV iron on the symptoms, clinical picture and quality of life of the treated~     patients.~   "
1153|NCT03042117|"~     Cardiovascular disease is one of the leading causes of death in the United States and the~     world. Many interventions relating to prevention have been emphasized as more risk factors~     for this devastating disease are discovered. Periodontal disease is known to have a close~     association with cardiovascular disease, but its role as a risk factor is still not well~     understood. Inflammation is a driving force in both of these diseases, creating a potential~     bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction~     in the body, which may predispose or even directly contribute to atheroma formation in the~     coronary arteries. In this study, the investigators will study the link between the~     inflammatory state of the body and will search for a correlation with levels of coronary~     artery disease and periodontal disease. Inflammatory markers such as high-sensitivity~     C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G~     (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment~     loss measured via pocket depth measurement, the distance from the gingival margin to the~     base of the pocket. A definitive link between these disease processes will allow preventive~     measures to be taken earlier to prevent this lifelong disease.~   "
1154|NCT03042104|"~     This clinical trial is a prospective, randomized, controlled, multi-center study. Patients~     will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with~     the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or~     not they are able to perform a treadmill stress test. Patients who have a positive stress~     test will be followed in a registry to collect data on subsequent treatment and mortality,~     as applicable.~   "
1155|NCT03042091|"~     This randomized clinical trial studies how well neomycin and metronidazole hydrochloride~     with or without polyethylene glycol work in reducing infection in patients undergoing~     elective colorectal surgery. Polyethylene glycol, may draw water from the body into the~     colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole~     hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to~     give preoperative neomycin and metronidazole hydrochloride with or without polyethylene~     glycol in reducing surgical site infection after colorectal surgery.~   "
1156|NCT03042078|"~     This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic~     approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus~     fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.~   "
1157|NCT03042065|"~     Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in~     children presenting with acute moderate to severe asthma.~   "
42160|NCT02505113|"~     To observe the etiology, diagnosis, management and prognosis of cavernous transformation of~     portal vein.~   "
1159|NCT03042039|"~     CareWell will enable the delivery of integrated healthcare to frail elderly patients in a~     pilot setting through comprehensive multidisciplinary integrated care programmes where the~     role of ICTs can foster the coordination and patient centered delivery care. Carewell will~     focus in particular complex, multi-morbid elderly patients, who the patients most in need of~     health and social care resources (35% the total cost of Health Care System) and more complex~     interventions due to their frailty and comorbidities (health and social care coordination,~     monitoring, self-management of the patient and informal care giver). ICT platforms and~     communication channels that allow sharing information between healthcare and social care~     professionals involved in the delivery care of these patients, facilitating their~     coordination, increasing their resoluteness and avoiding duplicities when tackling patients´~     diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based~     platforms can improve the adherence to treatment, enhance self-care and increase patient~     awareness about their health status , as well as, improve the empowerment of informal~     caregivers, who usually take care of these patients.~      According to this, it is hypothesized that the benefit of integrated care programmes based~     on (1) integrated care coordination and (2) patient empowerment & home support pathways~     supported by ICT is greater and essential for these patients. Care pathways will cut across~     organisational boundaries and will activate the most appropriate resources across the entire~     spectrum of healthcare and social care services available for both scheduled and emergency~     care. CareWell aims to scale up the services in pioneer regions and share their approach,~     learning from and supporting the other pilot sites which are at different levels of maturity~     in respect to designing, developing and implementing new ways of providing integrated care~     services.~   "
1160|NCT03042026|"~     We will compare the features of 3D stereophotography of acromegaly patients with that of~     healthy people. We hope to develop a computerized model to help screening acromegaly~     patients for early detection and treatment.~   "
1161|NCT03042013|"~     The purpose of the study is to evaluate long-term safety and tolerability of continuous~     treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273~     study which has completed, at a minimum, the primary analysis or have completed the~     individual study evaluation period and for whom the investigator feels the subject may have~     potential to continue to derive clinical benefit from treatment with ASP8273.~   "
1162|NCT03042000|"~     At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy~     (NCRT) followed by radical surgery has become the standard of care for the locally advanced~     mid/low rectal cancer, having been proved to substantially improve the local control of the~     disease, whereas not being able to improve the long-term survival. According to present~     clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal~     cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent~     5FU based chemotherapy, followed by the radical resection of the tumor. After surgery,~     adjuvant chemotherapy (ACT) is recommended for all these patients without considering the~     postoperative pathological results. Recently, however, some authors proposed that different~     strategy of combined modality therapy should be applied in different patients according to~     their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the~     basis of investigator's previous clinical practice and researches, investigators plan to~     stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several~     subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy~     will be applied in different groups, at the aim of improving the overall therapeutic~     effects, as well as reducing the treatment adverse effects.~      This research consists of four trials.~   "
1163|NCT03041987|"~     This study aimed to explore underlying mechanisms of chronic kidney disease progression and~     its association with adverse consequences. It will enroll approximately 5000 pre-dialysis~     chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up~     for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and~     biomaterials will be collected at baseline and annually. The principal clinical outcomes of~     the study consist of renal disease events, cardiovascular events, and death.~   "
1164|NCT03041974|"~     During storage, red blood cells (RBCs) undergo changes collectively termed Storage~     lesions. these changes may have an impact of the outcomes of transfused patients. One of~     these changes is the release of microparticles by RBCs and other blood cells types. The aim~     of the study is to (1) quantify red cell- and platelet-derived microparticles in RBC~     concentrates, and (2) evaluate the impact of transfused microparticles (MPs) on survival and~     post-transfusion complications in critical care patients participating in the ABLE trial~     (ISRCTN44878718).~   "
1165|NCT03041961|"~     There is an increasing interest in the effects of various food derived polyphenols on~     vascular function. Arguably the most well-established vascular benefits are attributed to~     flavanols from cocoa beans and this has been supported by a successful health claim through~     the European Food Safely Authority in 2012. Berry fruits are another rich source of~     polyphenols that have vasoactive properties, and there is a growing body of research~     exploring these effects in various berries (blueberries, cranberries, strawberries) and~     other fruit products with similar polyphenol composition. A key (poly)phenol in berries and~     other fruits believed to provide much of the benefit is anthocyanins. When given as an~     isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both~     acutely and in response to chronic consumption over 12 weeks.~      Aronia berries are a native North American berry with high naturally occurring anthocyanins~     among other polyphenols. Based on their polyphenol composition, there is growing interest in~     the potential for Aronia berries to elicit health promoting cardio-metabolic effects.~     Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may~     improve blood vessel function.~      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts~     of differing polyphenol dose on vascular endothelial function.~   "
1166|NCT03041948|"~     Surgical intervention to treat a inguinal hernia is a very common pediatric surgical~     procedure, often performed using an inguinal incision. Children who undergo hernia repair~     can suffer from a significant degree of discomfort postoperatively. The investigators are~     evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US~     guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative~     analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block~     leads to more effective pain control post-operatively while in hospital relative to an US~     guided CE block for inguinal hernia surgery.~   "
1169|NCT03041909|"~     This is an open label, single arm study which will enroll up to 16 subjects with SCD who~     previously participated in the GBT440-001 study.~      Dosing of study drug will be for 2 to 6 months, depending on subject's dose assignment in~     the last administration of study drug in GBT440-001.~      The primary objective of the study is to evaluate the safety and tolerability of up to a~     total of 6 months dosing of subjects with SCD who participated in the GBT440-001 study.~   "
45641|NCT02459600|"~     Assessment of refraction measurements in children under general anesthesia, with or without~     cyclopelgic eye-drops~   "
1172|NCT03041870|"~     Previous studies have already revealed the involvement of the serotoninergic system in the~     social behavior process. For example, more serotonin (5HT) was found in dominant male adult~     monkeys. Little is known about the serotoninergic implication in human's social behavior.~     The project aims to clarify the role of the serotoninergic system in social behavior in~     relation to the process of social hierarchical information. In order to determine how~     serotoninergic system is involved, the investigator will use a new technic TEP-fMRI. This~     technic allows us to measure the brain activity and the serotoninergic transporter occupancy~     (using the [C11]-DASB) at the same time. The current study aims to investigate whether~     serotonin transporter (5-HTT) activity correlates with the neural response (BOLD) during the~     detection of social dominance in facial expressions or other measures of social information~     processing. Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and~     neuropsychological questionnaires will give at the investigator more information and allow~     to investigate whether performance on social information processing is modulated by~     personality trait and genotype.~   "
1173|NCT03041857|"~     The objective of this research project is to perform a comparative study on the in vivo~     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed~     Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and~     downhill walking by means of videofluoroscopy.~   "
1174|NCT03041844|"~     The purpose of this study is to evaluate the effect of low frequency, low intensity~     ultrasound treatment on wound healing and health-related quality of life with a randomized~     clinical trial of patients with venous ulcers or diabetic ulcers.~   "
1175|NCT03041831|"~     This qualitative study seeks to assess whether mobile health technologies are helpful for~     older adults. It is the first in a series of four studies whose overarching goal is to~     conduct a program of pilot research aimed at developing and evaluating a technology-assisted~     wellness intervention for older adults with obesity who may or may not live in a rural area.~   "
1176|NCT03041818|"~     The purpose of this study is to develop healing riding algorithm applicable in rural riding~     centers and to apply this to children with cerebral palsy.~   "
1177|NCT03041805|"~     The aim of the study is to make a validation of Caprini score in patients undergoing~     varicose veins surgery, especially endovascular procedures (endovascular laser treatment -~     EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to~     identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will~     benefit from prophylactic anticoagulation.~   "
1178|NCT03041792|"~     This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,~     methodology study to assess the effect of 6 weeks of liraglutide administration on food~     intake in obese subjects.~   "
1179|NCT03041779|"~     To assess the prevalence of pain score for perineum pain following childbirth followed by~     phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal~     suppository in postpartum perineum pain secondary to perineal trauma.~   "
1180|NCT03041766|"~     The clinical trial phase 2a is designed to assess the safety of the active ingredient~     (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49~     years of age with a history of infection with intestinal and urinary schistosomiasis, living~     in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in~     the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in~     adults is considered to be a preliminary step in safety before starting trials in children~     in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.~   "
1181|NCT03041753|"~     Background: stroke is a major cause of death and disability. Intravenous thrombolysis and~     mechanical thrombectomy are able to re-open occluded vessels and save the ischemic tissue~     from death. However, recanalization of the occluded vessel may trigger activation of~     detrimental molecular pathways and exacerbate blood brain barrier (BBB) disruption,~     eventually determining hemorrhagic transformation (HT) or cerebral edema (CE), causing the~     so-called reperfusion injury. There is increasing evidence that a number of factors~     measurable as circulating biomarkers, particularly metalloproteinases (MMP), contribute to~     reperfusion brain injury. Preliminary data show that BBB disruption can be traced in vivo by~     Computed Tomography Perfusion (CTP) imaging. The aim of this study is to evaluate the~     effects of circulating and imaging biomarkers in relation to reperfusion injury.~      Methods: consecutive patients presenting with acute ischemic stroke in the anterior~     circulation territory, scoring≥7 on NIHSS, candidates to intravenous thrombolysis or to~     endovascular treatment, will be enrolled in one hospital centre. Circulating levels of pro-,~     anti-inflammatory, immunomodulatory factors, metalloproteinases and their~     inductors/inhibitors, factors of endothelial dysfunction and fibrin resistance to lysis will~     be measured in blood samples taken from each patients pre-thrombolysis and 24 hours after~     thrombolysis. Biomarker levels will be studied in relation to CTP measures of BBB~     permeability and in relation to imaging signs of reperfusion injury after acute~     interventions, such as hemorrhagic transformation and cerebral edema.~      Results: enrollment started on October 2015. As of January 2017, 70 patients have been~     included. Results are expected by the end of 2018 with an estimated sample size of 140~     patients. Using a definite protocol, a prospective collection of data, and an adequate~     number of patients assuring statistically powered data, this study will integrate clinical~     information with imaging and biological factors involved in reperfusion injury after~     cerebral ischemia.~   "
1182|NCT03041740|"~     The primary study objective is to assess the safety and feasibility of PFOB as a liquid~     breathing medium for up to ten days in subjects with severe Bronchopulmonary Dysplasia~     (BPD).~   "
1183|NCT03041727|"~     The study purpose is to compare the effects of Fascial Manipulation added to standard~     exercises protocol versus the simple exercises protocol.~   "
1192|NCT03041610|"~     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically~     inactive participants with chronic heart failure with reduced ejection fraction will be~     randomly assigned to intervention or control arms.~      The six-month intervention will consist of an individualized pedometer-based walking program~     with weekly step goals, monthly face-to-face sessions with the physician, and monthly~     telephone calls with the research nurse. The intervention will be based on effective~     behavioral principles (goal setting, self-monitoring, personalized feedback).~      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes~     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,~     average daily step count measured by accelerometry, anthropometric measures, symptoms of~     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.~   "
1193|NCT03041597|"~     To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed~     versus immediate loading, using abutments with the SynCone® concept for implant-supported~     detachable dental prosthesis (ISDDP) in the edentulous upper jaw.~   "
10230|NCT02923336|"~     The purpose of this study is to evaluate the influence of non betablockers in~     gastrointestinal motility (transit time) in patients with liver cirrhosis.~   "
1184|NCT03041714|"~     Background:~      Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic~     tremor is when a person also has dystonia. Dystonia is a condition in which muscle~     contraction causes changes in posture. Researchers do not fully know what areas of the brain~     cause these tremors, or how the types differ. They also do not know what tests can identify~     the differences.~      Objective:~      To look at differences between essential tremor and dystonic tremor.~      Eligibility:~      People ages 18 and older with or without tremor~      Design:~      Participants will be screened with medical history, physical exam, and urine tests. Those~     with tremor will complete questionnaires about how tremor affects them.~      The screening and study visits can be done on the same day or on separate days.~      Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI)~     and tremor testing.~      For MRI, participants will lie on a table that slides in and out of a cylinder that takes~     pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes~     about 2 hours.~      Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation~     of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire~     coils will be held on the scalp and a brief magnetic field will be produced. A brief~     electrical current will pass through the coils. For the other tests, small sticky pad~     electrodes will be put on the skin. Participants will move their hand when they hear a~     sound. They will get weak electrical shocks to their fingers. These tests will take 3-4~     hours.~      Participants can take part in either or both parts of the study.~   "
1185|NCT03041701|"~     Background:~      Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two types are~     embryonal RMS (ERMS) and alveolar RMS (ARMS). Dasatinib may block over-expression of a~     certain enzyme. Ganitumab may block a certain growth factor, which might suppress tumor~     growth. This drug combination may help slow tumor growth in people with ERMS and ARMS.~      Objective:~      To see if dasatinib combined with ganitumab is safe and shrinks or slows the growth of~     tumors in people with ERMS and ARMS.~      Eligibility:~      People any age who have ERMS or ARMS that did not respond to previous treatment and who can~     swallow tablets~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and heart tests~        -  Scans/x-rays~        -  Tissue sample: This can be from previous surgery or biopsy.~        -  Optional biopsy: A small piece of the tumor is removed with a needle.~      Participants will be asked to co-enroll in another protocol.~      Participants will get a drug interaction handout and wallet card that show what foods and~     medications to avoid.~      Participants will be treated in cycles. The first cycle is 35 days and the rest are 28 days.~     Participants will take dasatinib by mouth daily. They will get ganitumab through an IV every~     2 weeks. They will have a physical exam every 1-2 weeks, and urine and heart tests before~     most cycles.~      Participants will continue treatment as long as they do not have severe side effects or~     their tumors do not get worse.~      After ending treatment, participants will have a visit. This includes repeats of the~     screening tests.~   "
1186|NCT03041688|"~     This phase Ib trial studies the side effects and best dose of murine double minute~     chromosome 2 (MDM2) inhibitor AMG-232 when given together with decitabine in treating~     patients with acute myeloid leukemia that has come back, does not respond to treatment, or~     is newly diagnosed. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving MDM2 inhibitor~     AMG-232 together and decitabine together may work better in treating patients with acute~     myeloid leukemia.~   "
1187|NCT03041675|"~     Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus~     include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less~     and less effective over time. Some study revealed that Moxibustion and Acupuncture are~     effective in Paralytic ileus. Investigators try to find other treatment except of medicine.~     Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of~     Laser Acupuncture on Paralytic ileus.~   "
1188|NCT03041662|"~     This observational study of a national cohort of 600 Swedish PSC patients include yearly~     MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions,~     symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC~     patients and provide future possibilities to evaluate biomarkers for prognosis and early~     cancer detection.~   "
1189|NCT03041649|"~     The objective of this study is to compare two low profile balloon gastrostomy button enteral~     feeding devices, both currently used as standard of medical care. The investigators aim to~     compare family preference and rate of complications between the two devices in a prospective~     cohort of children. This is the first step in comparing initial and long-term outcomes along~     with the need for seeking medical advice for gastrostomy site-related complications.~      The secondary aim of this study is to follow this population long term (4 years) to document~     the prevalence of: granulation tissue, infection, skin breakdown, and how long the~     gastrostomy tube balloon remains functional (does not lose water).~   "
1190|NCT03041636|"~     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can delay,~     lower the amount of therapy you may need in the future, or possibly eliminate the need for~     future therapy in recently diagnosed CLL patients.~   "
1191|NCT03041623|"~     An objective of JIPS Registry is to examine disease prevalence of idiopathic interstitial~     pneumonias (IIPs), considering classification, background, and diagnostic methods based on~     American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory~     Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the~     ATS/ERS classification of 2002 and 2013.~   "
1194|NCT03041584|"~     To assess implant outcomes, both clinical and radiological, in a randomized study on guided~     implant placement after 3-year follow-up, compared to non-guided treatment.~   "
1195|NCT03041571|"~     A qualitative study assessing the impact of early narrative medicine practice on Medical~     Honors Program (MHP) students' attitudes regarding patient-centered interactions, through~     interviewing patients with chronic or life-limiting illnesses to obtain their illness~     stories.~      MHP students will develop a patient narrative for the patients interviewed. These narratives~     will be edited by the patient, and, with the permission of the patients, may be published as~     a collection of stories.~   "
1197|NCT03041545|"~     Physical activity during chemotherapy has been shown to increase patient health and~     wellbeing as well as improve outcomes in breast cancer patients. The primary aim of this~     project is to determine the feasibility of incorporating wearable sensors into clinical care~     by having breast cancer patients, undergoing chemotherapy, wear a commercially available~     monitor (Fitbit) that tracks physical activity, sleep, and heart rate monitor.~   "
1198|NCT03041532|"~     Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in~     the Western world. The decrease in incidence and mortality by CRC in the population~     undergoing screening has been observed. Colonoscopy is the recommended method for detecting~     tumors in early stages, as well as identifying and resecting adenomatous polyps, which are~     the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease~     incidence and mortality by CRC and avoid interval cancer. The literature shows that~     colonoscopy does not prevent right colon lesions in the same way as the left colon lesions,~     with most of the interval cancers located in the right colon. Studies published so far show~     an increase in the adenomas detection rate (ADT) in the right colon in a second~     visualization of this segment and an increase between 2 and 10% if this second examination~     is performed with the proximal retroflexion maneuver .Retroflexion is a safe maneuver in~     expert endoscopists. The aim of our study is to evaluate the ADT in right colon by means of~     a second visualization by performing proximal retroflexion or second frontal visualization~     at random in the CCR screening population.~   "
1199|NCT03041519|"~     This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy~     approach using Ensite NavX as the only imaging modality with conventional fluoroscopic~     approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional~     fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging~     modality.~   "
1200|NCT03041506|"~     Shoulder dislocation is the most common joint dislocation presented to the emergency room~     (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are~     often very painful and require some form of sedation, pain relief and muscle relaxation for~     reduction maneuvers. Several sedation protocols for reduction maneuver are described in the~     literature, and each institution is guided by its own protocol to optimize patient comfort~     and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam~     are the mainstay form of sedation for shoulder dislocation reduction.~      Sedation is not without risk, it is time consuming for the medical staff, and need personal~     supervision. Sedation under busy ER conditions can cause a burden to the medical team which~     can end up in treatment insufficiency and patient safety failure.~      Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an~     effective method for perioperative analgesia. However, there is limited data on performance~     of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic~     modalities Both techniques (block and sedation) for shoulder dislocation procedure are being~     performed for two years at the TLVMC, however no study was done to evaluate these two~     analgesic modalities.~      The current study compares sedation vs. US guided ISCB for the treatment of shoulder~     dislocation in the ER at the TLVMC.~      Study objective:~      Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder~     dislocation reduction in our institution.~      Study design:~      This is a prospective, randomized, interventional, open-label study with two arms- Sedation~     group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who~     is certified to perform sedation and the US guided ISCB will be conducted by a certified~     anesthesiologist.~      Primary outcome:~      Time frame measured from the beginning of reduction procedure until readiness for dismissal~     from the ER according to the physician decision.~      Secondary outcomes [short list]:~      Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and~     sedation failure rate, overall reduction success rate, readmission rate to the ER, daily~     activity level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome~     measure.~   "
1201|NCT03041493|"~     The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that~     we see in blood vessels of traditional cigarettes (TC) users. The investigators will also~     enroll non-smokers as controls, against which they will measure changes in blood vessels~     in TC and EC users.~   "
1202|NCT03041480|"~     To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2~     level in systemically healthy Chronic Periodontitis subjects and healthy controls.~   "
1203|NCT03041454|"~     Despite advances in the conduct and reporting of traditional systematic reviews, current~     evidence suggests that they are used infrequently by health care managers and policy makers~     in decision making. Managers and policy makers have suggested that concise presentation~     positively affects the use of systematic reviews. The purpose of this randomized controlled~     trial is to assess the impact of a traditional systematic review format compared with the~     innovative format on the ability of health care managers and policy makers to understand the~     evidence in the review and apply it to a relevant health care decision making scenario.~      The two end-user groups have different formatting needs and will therefore run 2 parallel~     studies, randomizing each group separately. Once participants have consented to participate,~     a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio).~     Unequal block randomization will be used and allocation will be concealed through central~     assignment. Outcomes assessors will be blinded and participants will be blinded to the~     citation of the review so that the traditional version will not be easily accessible in its~     original format from the relevant journal.~      This study will be the first study to engage health care managers and policy makers in the~     testing of formats for presentation of research evidence relevant to their needs. The~     results of the project will help increase the uptake of systematic review results in health~     care management policy decision-making, ultimately leading to informed decision making and~     positively impacting the health of Canadians.~   "
1204|NCT03041441|"~     The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in~     your head) in subjects with intracranial hypotension (a condition caused by leakage of the~     fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging~     (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment~     of this condition.~   "
1205|NCT03041428|"~     Mechanical ventilation, in spite of being a life-saving technique, can also induce lung~     injury (VILI) mediated by an inflammatory response, thus having a profound impact in the~     course of critically ill patients. Ventilatory strategies aimed to minimize this VILI have~     reduced mortality rates. Patients suffering cardiogenic pulmonary edema may need~     venoarterial extracorporeal oxygenation, at the same time they are being mechanically~     ventilated. The objective of this study is to analyze changes induced by the use of~     utraprotective ventilatory strategies in the inflammatory lung response of these patients~     and their impact on outcomes.~   "
1215|NCT03041298|"~     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic~     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from~     September 2011 to December 2013. The aim of this study, which was conducted in accordance~     with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to~     generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in~     Magnetic Resonance (MR) mammography.~   "
1206|NCT03041415|"~     While low-income midlife and older adults are disproportionately affected by chronic~     diseases that can be alleviated by regular physical activity, few physical activity programs~     have been developed specifically with their needs in mind. Those programs that are available~     typically do not address the recognized local environmental factors that can impact physical~     activity. This research aims to evaluate the added effects on two-year physical activity~     levels of a novel citizen science neighborhood engagement program (called Our Voice) when~     combined with an evidence-based, individually-focused physical activity program (Active~     Living Every Day), relative to the individually-focused program alone. The programs will be~     delivered in affordable housing settings, and represent a potentially scalable means for~     promoting physical activity across broader income groups in the US.~   "
1207|NCT03041402|"~     Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and~     cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted~     Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal,~     i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance,~     improves patient-ventilator interaction. A specific setting to generate neurally controlled~     Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators~     here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood~     gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.~      Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after~     extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory~     support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi~     (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper~     airway pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We~     assessed EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime),~     pressure-time product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds~     after initiation of patient effort, patient comfort, inspiratory trigger delay~     (DelayTR-insp), and the rate of asynchrony, as assessed by the Asynchrony Index (AI%).~   "
1208|NCT03041389|"~     The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and~     are often based on pharmacological treatments. It has been shown that the cognitive~     behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the~     effect of computerized cognitive behavioural therapy on insomnia in PD has not been~     evaluated before. The aim of this study is to demonstrate the beneficial effects of 6-weeks~     of computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in~     Parkinson's disease patients.~   "
1209|NCT03041376|"~     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically~     inactive participants with chronic heart failure with preserved or mid-range ejection~     fraction will be randomly assigned to intervention or control arms.~      The six-month intervention will consist of an individualized pedometer-based walking program~     with weekly step goals, monthly face-to-face sessions with the physician, and monthly~     telephone calls with the research nurse. The intervention will be based on effective~     behavioral principles (goal setting, self-monitoring, personalized feedback).~      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes~     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,~     average daily step count measured by accelerometry, anthropometric measures, symptoms of~     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.~   "
1210|NCT03041363|"~     To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of~     triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed~     with glucose transporter type 1 deficiency disorder (G1D).~   "
1211|NCT03041350|"~     Direct medical control using video conferencing capabilities of smartphones has never been~     conducted in out-of-hospital cardiac arrest patients. This study was conducted to~     investigate its feasibility and treatment effectiveness in out-of-hospital cardiac arrest~     (OHCA) patients using a real-time smartphone video call.~   "
1212|NCT03041337|"~     The aim of this registry will be to compare the pathophysiological response of the~     morphology and function of the right heart and pulmonary circulation assessed with resting~     and stress-echocardiography in patients with various cardiovascular diseases, to compare~     them to healthy individuals. The physiological response in healthy individuals as well as~     elite athletes, defined as athletes participating at national and international~     competitions, will also be evaluated. Patients will be enrolled both prospectively as well~     as retrospectively and the will be evaluated by resting and stress echocardiography, which~     are part of the routine clinical practice.~      All clinical outcome measures will be collected as part of routine examinations. The~     measurements will include systolic and diastolic pump function of the right and left~     ventricles and other echocardiographic parameters. Moreover, a comparison of these~     parameters among different groups will be performed. Other optional assessments will~     include: exercise capacity assessed with 6-minute walking distance, World Health~     Organization functional class (WHO functional class), peak oxygen uptake assessed by~     spiroergometry. Patients will be evaluated at baseline and each year with the aforementioned~     procedures according to the sites clinical routine.~   "
1213|NCT03041324|"~     The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and~     plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913. SB-913 is~     an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It~     inserts a correct copy of the IDS gene into the Albumin locus in hepatocytes with the goal~     of lifelong therapeutic production of the IDS enzyme.~   "
1214|NCT03041311|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing antitumor efficacy when~     administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line~     treatment for patients with newly diagnosed extensive-stage SCLC.~      The study is a randomized, double-blinded, placebo-controlled design. The study will include~     3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and~     Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study~     treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be~     enrolled in the study.~   "
1216|NCT03041285|"~     The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in~     combination with palliative radiotherapy for metastatic prostate cancer~   "
1217|NCT03041272|"~     The purpose of this study is to identify the incidence rate and characteristics of~     aggressive behavior perpetrated by patients and visitors in inpatient medical units and to~     understand the role of missed care events, professional quality of life and self-efficacy in~     relationship to aggressive events.~   "
1218|NCT03041259|"~     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of~     Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia~     Patients with Rutherford Class 4, 5 and 6 Disease~   "
1219|NCT03041246|"~     Pregnancy and vaginal delivery are considered as the main risk factors for damage to the~     pelvic floor. There are various ways to measure the strength of the pelvic floor and to~     evaluate functional problems. Manual mobilization of the pelvic floor is a well-known~     treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and~     exercise for improvement of pelvic floor function and strength. The aim of this study is to~     analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function~     and strength of the pelvic floor muscles as well as parameters presumed to be influenced by~     the strength of the pelvic floor in pregnant women.~   "
1220|NCT03041233|"~     The purpose of this registry is to assess the performance and clinical effectiveness of a~     combination of SJM mapping and ablation products in the treatment of subjects with atrial~     fibrillation (AF).~   "
1221|NCT03041220|"~     Retrospective chart review using both out patient and inpatient records of obese patients~     (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate~     the patient's BMI, their skin incision type at time of c-section, their co-morbidities,~     number of previous c-sections and post partum follow up for wound infection, wound~     separation and wound breakdown. We will also review operative notes to evaluate blood loss,~     length of surgery and complications during surgery. We will obtain maternal characteristics~     and information about the pregnancy.~   "
1222|NCT03041207|"~     This is a prospective study with three specific aims: (1) To convene a consensus conference~     to develop a guideline for antibiotic use in infants (age < 3 yrs) with suspected~     ventilator-associated infection; (2) To evaluate outcomes before and after implementation of~     the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course~     of mechanical ventilation~   "
1223|NCT03041194|"~     This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the~     dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is~     to determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.~   "
1224|NCT03041181|"~     This is a randomized phase II study assessing the activity of docetaxel combined with~     nivolumab compared to docetaxel alone in metastatic or recurrent non-squamous non-small cell~     lung cancer (NSCLC) subjects who recently progressed on single-agent nivolumab.~      Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with~     docetaxel alone or docetaxel in combination with nivolumab, and stratified according to~     Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 vs 2.~   "
1225|NCT03041168|"~     The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed~     by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will~     compare a new application of a technology, the CSS device, to reference standards for~     assessment of carotid disease.~   "
1226|NCT03041155|"~     The research protocol is a Randomized Clinical Trial that has the effectiveness of a given~     respiratory muscle training protocol over the indicative variables: Pulmonary function;~     Markers of oxidative stress and inflammation, endothelial markers and Quality of life in~     patients with chronic kidney disease undergoing hemodialysis. According to the~     Investigators, this topic was proposed since it is known that several pulmonary~     complications occur as a consequence of chronic kidney disease due to uremic myopathy.~     Therefore, the hypothesis is that the application of a respiratory muscle training protocol~     will contribute positively pulmonary functionality and a decrease in oxidative stress and~     inflammation in chronic kidney patients, consequently, will bring improvement in the quality~     of life for these patients. The Patients will be divided into two groups: control group - No~     intervention of the Muscular Training (CG) And Intervention Group (GI). The intervention~     protocol will be composed of respiratory muscle training And lasts for two (2) months, with~     three (3) visits per week. It will be carried out through Threshold PeP appliance. The~     twelve (12) first training sessions will have a total duration of 30 minutes 15 minutes with~     inspiratory load of 20 cmH2O and 15 minutes with expiratory load of 20 CmH 2 O; and the~     others (12) twelve sessions will last 40 minutes each, with 20 minutes with an inspiratory~     load of 20 CmH2O and 20 minutes with expiratory load of 20 cmH2O. The variables evaluated~     will be: muscular strength Respiratory (maximum inspiratory pressure and maximum expiratory~     pressure - Pimáx and Pemáx); Lung function (Slow Vital Capacity - CVL, forced expiratory~     volume in the first minute - VEF1, Vital Capacity Forced - CVF and Maximum Voluntary~     Ventilation - VVM); Serum levels of oxidative stress markers, Inflammatory markers and~     endothelial markers.~   "
1227|NCT03041142|"~     Obesity has been considered as one of the primary factors for the development of pathologies~     and cardiovascular risk factors. In the child it has been mediator for the development of~     these comorbidities still in childhood, in the adolescence and more strongly in the adult~     age, at the time of most cardiovascular events with death records. Objective: To analyze the~     effects of an interdisciplinary intervention program on the cardiovascular risk factors of~     overweight and obese children. Methods: It was conducted a physical activity program,~     nutritional and psychological orientations, lasting ten weeks with overweighed children and~     their mothers. Thirty-three children with BMI considered overweight and obese participated~     in the study, they were divided into two groups, experimental (n=14) and control (n=19).~     Physical activities occurred 3 times a week with children and once a week with mothers.~     Nutritional and psychological counseling occurred once a week with both children and~     mothers. BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory~     fitness, systolic and diastolic blood pressure, lipid profile, glucose, left ventricular~     mass, daily energy intake and parental perception of children's weight were analyzed. For~     the statistical analysis it was first verified the normality of the data by the Shappiro~     Wilk test, with the variables that presented normality the possible differences were~     verified through the Anova test of mixed design with the post hoc of Bonferroni, for the~     normal variables, but that presented significant difference in the initial moment of the~     research, it was resorted to the Ancova, finally, for the non-normal variables the U tests~     of Mann Whitney and Wilcoxon.~   "
1228|NCT03041129|"~     The Investigators will measure if hepatic glucose metabolism is upregulated towards de novo~     lipogenesis (DNL) via multiple intrahepatic pathways in obese girls with PCOS and hepatic~     steatosis (HS), compared to PCOS without HS and obese controls without HS. HS will be~     correlated to relative post-prandial hyperglycemia. Post-prandial hyperglycemia will be~     worse or remain unchanged in youth treated with oral contraceptives and better with~     metformin.~   "
48649|NCT02420288|"~     The aim of this study is to examine the effect of a supervised physical exercise program~     during pregnancy on fetoplacental growth.~   "
1231|NCT03041090|"~     PET (Positron Emission Tomography) images are used to help make patient management decisions~     in staging and treatment assessment, often after a cancer diagnosis.~      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is~     known as extravasation or infiltration, and it compromises the doctor's ability to read the~     PET image. Often, the site where the tracer is injected into the vein (usually in the inside~     of the elbow) are not in the images taken, so reading physicians are unaware that an~     extravasation or infiltration has occurred.~      Technology exists to capture time activity curves (amount of tracer in a location over a~     period of time) during the PET tracer uptake period (usually once the tracer is injected,~     the tracer circulates for 60 minutes prior to images), which can enable physicians to~     accurately detect extravasations and infiltration. This information is currently unavailable~     to physicians reading routine PET/CT (computed tomography) scans.~      Time activity curves information gathered from these sensors during the circulation period~     appear to match the brief pictures taken approximately 70 minutes after the tracer~     injection.~      This study will determine if these time activity curves correspond to PET images of the~     injection site taken during the tracer uptake period. If time activity curves correspond to~     PET images, they can be used to determine if the tracer was properly injected. If there was~     an improper injection, clinicians can be alerted to this fact and interpret the image with~     this additional information.~   "
1232|NCT03041077|"~     Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the~     most common site of joint discomfort regardless of age. Nearly half of people with knee~     joint discomfort use natural supplements to alleviate symptoms, but more research is needed~     to determine their effectiveness. In a previous study, we measured the effect of 8-weeks~     ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support,~     Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and~     function in adults with self-reported joint discomfort (Nutr J. 2013;12:154). This study~     will be repeated using Instaflex Advanced, with a longer 12-week time period. The Instaflex~     Advanced supplement includes six products: turmeric, resveratrol, Boswellia serrata,~     collagen, hyaluronic acid, and black pepper extract. This unique blend may improve joint~     function and increase mobility, but has not yet been tested in humans using a randomized,~     double-blinded, placebo-controlled research design. The primary purpose of this study is to~     assess the effect of 12-weeks ingestion of the Instaflex Advanced supplement compared to~     placebo in improving knee function in adults with self-reported knee joint discomfort.~   "
1233|NCT03041064|"~     This is a randomized, double-blinded, single-center, split body and split face, multiple~     natural sunlight exposure evaluation of two marketed sunscreens under actual use conditions~     in healthy volunteers. Eligible subjects will be randomized to two treatment randomization~     groups: Left SPF (Sun Protection Factor) 100+/Right SPF 50+ or Left SPF 50+/Right SPF 100+.~     Assessment of erythema and pigmentation will be performed at baseline and after all natural~     sunlight exposure periods which will occur on at the same beach location over the course of~     5 consecutive days. Subjects will be suspended from further natural light exposure periods~     following the observation of sunburn at any exposed body site.~   "
1234|NCT03041051|"~     The purpose of this study is to determine the effect of a combined vaccination schedule of~     the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine~     (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.~   "
1235|NCT03041038|"~     The ichthyoses are a group of lifelong genetic disorders which share characteristics of~     generalized skin thickening, scaling and underlying cutaneous inflammation. There are no~     therapies based on growing understanding of what causes the disease. However, there have~     been recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and~     IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the~     inflammation. Investigators propose that IL-17-targeting therapeutics will safely suppress~     the inflammation and possibly the other features of ichthyosis, improving quality of life.~   "
1236|NCT03041025|"~     GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis~     (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no~     approved disease modifying therapies and it is an area of high unmet medical need.~     GSK2330811 has been shown to bind and neutralize Oncostatin M (OSM) that has been associated~     with fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,~     randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will~     be the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female~     participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a~     disease duration of <= 60 months will be enrolled. Approximately 24 to 40 participants will~     be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted~     to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is~     planned to consist of at least 4 participants, randomized such that 3 participants will~     receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to~     consist of at least 20 participants, randomized such that participants will receive~     GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up~     to 34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and~     follow-up period of 16 weeks.~   "
1237|NCT03041012|"~     To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or~     administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent~     HIV-1 reservoir in treatment naïve HIV-1 patients initiating antiretroviral therapy (ART)~   "
1238|NCT03040999|"~     The purpose of this study is to determine the efficacy and safety of pembrolizumab given~     concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT~     in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The~     primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in~     combination with CRT with respect to event-free survival (EFS) per Response Evaluation~     Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).~   "
1239|NCT03040986|"~     This phase II trial studies how well selumetinib sulfate works in treating patients with~     pancreatic cancer with KRAS G12R mutations that has spread from where it started to nearby~     tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
1241|NCT03040960|"~     The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic~     surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not~     well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over~     the years and risk factors of these infections in a french University Hospital.~   "
1242|NCT03040947|"~     The purpose of this study is to develop imaging protocols when using cardiovascular magnetic~     resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The~     National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to~     support the numerous investigator initiated projects in patients with various cardiac~     pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be~     shortened for patients with underlying cardiac diseases.~   "
1243|NCT03040934|"~     This study is a prospective, multi-center, open-label, randomized controlled clinical~     trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting~     coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™)~     comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects~     with total coronary occlusion lesion(s).~   "
1244|NCT03040921|"~     This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of~     performing uterine transposition before chemoradiation for rectal cancer and uterine~     reimplantation after the treatment.~   "
1245|NCT03040908|"~     The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of~     chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global~     response of various physiological systems (respiratory, cardio-vascular, neurologic,~     metabolic and musculosquelettic) in a situation simulating a daily life activity. In~     children with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a~     low level of fetal hemoglobin and low red cell deformability. Our team previously reported~     that in a population of children with sickle cell disease, highly treated with hydroxyurea,~     the sole factor which was independently linked to the 6MWT was the presence of silence~     infarct.~      As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly~     correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of~     endothelial and inflammation parameters and new hemolysis markers and b) if the presence of~     silent infarct and the 6MWT are correlated with this biological markers.~      This cross-sectional study will include sickle cell disease patients regularly followed for~     more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier~     Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre,~     Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell~     disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent.~     Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe~     cognitive disability, femoral osteonecrosis with functional impairment), hospitalization~     and/ or transfusion in the last 3 months for acute event.~      Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT~     will be performed in steady state. Studied analysis will be: coagulation factors, free~     hemoglobin, Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein~     (HS-CRP), Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and~     Selectins.~      With this study, the investigators expect to validate new predictive markers for~     cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop~     these complications.~   "
1246|NCT03040895|"~     This study evaluate if a parental guidance programme based on the International Child~     Development Programme (ICDP) offered to the general Norwegian population, has an effect on~     caregivers, the relationship between caregiver and child, and on children's Development.~   "
1247|NCT03040882|"~     The post-operative treatment of pediatric patients operated for the correction of flat foot,~     sees today the use of preformed leg-foot splint (Walker) as an alternative to the~     application of plaster casts. The change of the immobilization system has led to the~     appearance of problems of tolerability in particular in the skin. The problems persist also~     after placing a polyurethane foam dress at the heel in the immediate postoperative period.~     The aim of this study is to evaluate the effectiveness of a cotton sock applied inside the~     leg-foot splint in children operated vs the Elastic Compression Wraps in reducing the~     incidence of cutaneous lesions.~   "
1248|NCT03040869|"~     Coronary heart disease (CHD) is the leading global cause of human death. Over the past~     decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the~     progression of clinical research and development of technical means and the mortality of CHD~     has decreased by nearly 50% in western countries [1]. However, there are surveys shows that~     with the improvement of living standards and changes in lifestyle, the incidence of CHD is~     still rising in China and other developing countries, and the prevalence trend is obvious~     younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less~     than or equal to 45 years. Compared with other age-group CHD, young CHD has the following~     characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and~     incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary~     syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two~     extremes often exists in coronary lesions: mild or no atherosclerosis and severe~     triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in~     the same site repeated after interventional treatment, rapid progress of lesion in~     non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or~     bypass surgery, but the rate of revascularization is significantly higher in following 10~     years.~   "
1249|NCT03040856|"~     Omega-3 fatty acids are good fats, and are among the most important nutrients lacking in~     Western diets today. The average person in developing countries consumes less than 100 mg of~     DHA daily. With increasing awareness of the importance of DHA, many people realize that they~     need to make a change in their diet by adding DHA-rich foods or supplements.~      The aim of this study is to learn the effect of different supplementations from the omega 3~     group on the maternal and fetal fatty acid profile during pregnancy and to study their~     epigenetic influence.~   "
1250|NCT03040843|"~     Altered mental status (AMS) is common in older patients. However there is a lack of~     standardization in the definition and documentation of this compliant. Different perception~     of AMS can cause negative impact on interpretation and obtaining scientific data. Although~     definition of AMS is so complicated, clinical documentation can be detected in these~     patients with AMS.~   "
1251|NCT03040830|"~     The study aims to know whether starting progesterone luteal support in intra cytoplasmic~     sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of~     embryo transfer compared with starting luteal support on day of embryo transfer~   "
1299|NCT03040206|"~     This study is to investigate the prognostic significance of enhanced International~     Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed~     nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal~     PTCL patients.~   "
1252|NCT03040817|"~     Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary~     pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is~     limited medical therapeutic options for these diseases. Gastric peroral endoscopic~     pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a~     minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases~     are rarely explored. So, there is a cooperative group composed of five clinical centers for~     clinical research in G-POEM.~   "
1253|NCT03040804|"~     To establish the safety of radiotherapy in the treatment of advanced hidradenitis~     suppurativa. Patients will receive radiotherapy treatment over one week and then they will~     be followed for the next three months.~   "
1254|NCT03040791|"~     Prostate Cancer (PC) is the most frequent cancer in men, accounting for 21% of new cases of~     cancer in men in the United States. Among the four most incident tumors (breast, lung and~     colorectal cancer); prostate cancer is the only that does not have any predictive biomarker~     to guide the treatment. Even though the molecular heterogeneity of PC is well-documented,~     treatment has not been molecularly stratified and the need for genetic prognostic and~     predictive markers is critical.~      DNA repair defects (DRD), mainly in the Homologous Recombination (HR) pathway (such as~     BRCA1, BRCA2, ATM and CHEK2) are emerging as potential biomarkers in prostate cancer. It is~     well known BRCA1 and BRCA2 carriers have better Progression-Free Survival (PFS) and Overall~     Survival (OS) than non-carriers in ovarian cancer. Differently than ovarian tumors that BRCA~     mutations provides a good prognosis, PC patients who harbor HR defects have a higher Gleason~     score 6, an increased risk of recurrence and poor prognosis. The predictive role of DRD in~     PC was demonstrated in a recent trial using Olaparib, a PARP inhibitor, in DRD carriers.~     This trial showed 88% of response rate with Olaparib, a PARP inhibitor that acts in HR~     pathway by synthetic lethality.~      Recent data demonstrated important association between HR deficient high-grade serous~     ovarian cancer (HGSOC), high neoantigen load and high expression of PD-1/PD-L1 compared with~     HR proficient HGSOCs 10. This study showed that BRCA1 and BRCA2 mutations increase the~     number of tumor-infiltrating lymphocytes (TILs) and confer a better prognosis. The~     unprecedented success of immunotherapy in malignant disorders has provided evidence that the~     patient's immune system can be improved to attack established tumors, mainly melanoma,~     non-small cell lung cancer and kidney cancer. A high mutational burden increases the~     likelihood of the development of specific neoepitopes that would confer clinical benefit~     from CTLA-4 and PD-1 blockade.~      These data showed that specific DNA repair defects increase the mutational burden, the~     expression of PD-1/PD-L1 and TILs; and could improve the response to immunotherapy in~     cancer. This rationale was already tested in a trial that evaluated the PD-1 checkpoint~     inhibitor Pembrolizumab in mismatch-repair deficient patients, a kind of DNA repair defect~     by definition. This important trial showed that this DRD predicted clinical benefit of~     immune checkpoint blockade in many types of cancer, especially colorectal cancer.~   "
1255|NCT03040778|"~     The overall purpose of this project is to answer the following clinical question: Among~     Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with~     the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to~     those treated with standard of care alone, have decreased areas of exposed bone after one~     year of treatment?~   "
1256|NCT03040765|"~     This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With~     Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce~     osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray~     absorptiometry scan as a standard of care by the radiology department, then a blood test for~     bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the~     chemistry lab.~      Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and~     willing to participate in the study will be enrolled after consenting by the primary~     investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of~     the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be~     done to compare the response of the two medications. The potential risks include the~     drug-related side effects~   "
1257|NCT03040752|"~     A randomized controlled double blinded study included 200 women with preterm contractions.~     After successful arrest of contractions women were randomized into 2 equal groups: GI women~     received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets~     every 6 hours. The primary outcome was gestational age at delivery and the secondary~     outcomes include episodes of recurrent preterm labor, mode of delivery, maternal side~     effects and neonatal outcome~   "
1258|NCT03040739|"~     Acetabulum fracture are high energy trauma in young people as it can be the result of a~     simple fall in elder people. This fracture generates an incongruity between acetabulum and~     femoral head. So surgery is recognized as the best treatment even if technically difficult~     because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .~      The aim of the study is to evaluate the effect of peroperative navigation system on~     reduction of the acetabulum articular surface~   "
1259|NCT03040726|"~     The goal of this clinical research study is to learn if netupitant/palonosetron can help to~     decrease chronic nausea and vomiting in patients with cancer. The safety of the study drug~     will also be studied.~      Some participants will receive the study drug and some will receive a placebo. A placebo is~     not a drug. It looks like the study drug but is not designed to treat any disease or~     illness. It is designed to be compared with a study drug to learn if the study drug has any~     real effect.~   "
1260|NCT03040713|"~     This study is designed to assess the usefulness of 18F-AV-1451 in Positron Emission~     Tomography imaging for subjects diagnosed with Frontotemporal Dementia.~   "
1261|NCT03040700|"~     The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three~     different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A~     total of 600 patients will be included and followed for 5 years. Patients will be randomly~     allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm~     will be followed by regular medical visits only every 6 months; patients in the functional~     arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be~     subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless~     symptoms every 2 years after the first year post-surgery. The primary outcome will be the~     incidence of death, acute myocardial infarction or myocardial revascularization.~   "
1262|NCT03040687|"~     Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and~     therapeutics are under development to prevent ETEC disease in children and travelers. One~     approach is to use passive protection (antibodies) to prevent infection. The purpose of this~     study are to assess the safety of serum-derived bovine immunoglobulins in healthy adult~     subjects when orally administered and to estimate protective efficacy of those preparations~     against moderate-severe diarrhea upon challenge with the ETEC strain B7A.~   "
1384|NCT03039101|"~     The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4~     integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited~     by pretreatment with an FDA approved leukotriene antagonist (montelukast).~   "
1263|NCT03040674|"~     The purpose of the Lung Institute is to collect and isolate a patient's own cells and~     platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung~     Institute's treatment is limited to self- funded patients with chronic lung disease -~     chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The~     patient's cells and platelet rich plasma are collected through venous or bone marrow~     harvesting techniques.~      The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse~     events, a perceived improvement in the patient's lung condition (to be determined by their~     ability to be more physically active; walking greater distances with or without oxygen and~     improved quality of life scales), an improvement in the FEV1 among COPD patients, the~     ability to reduce their use of oxygen and possibly to stop it., the ability to function well~     without the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections,~     reduction in emergency room visits and exacerbations related to their disease.~   "
1264|NCT03040661|"~     Patients who undergo ablation for AF typically have 2 sheaths placed in each groin,~     including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During~     the procedure, heparin is administered to maintain a target ACT > 300 seconds. At the~     conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained.~     There are at least 2 ways of obtaining hemostasis after venous access. In the manual~     hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked~     20 later, and if < 220 msec, the sheaths are pulled and hemostasis is achieved with manual~     pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around~     the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore~     obviate the need for assessment of the ACT, protamine administration, and manual pressure~     (Figure of 8 Group).~   "
1265|NCT03040648|"~     Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to~     treat spinal radicular pain. However, inadvertent intravascular injection can lead to severe~     neurologic complications. Digital subtraction angiography (DSA) during epidural block might~     increase the detection rate of intravascular penetration, compared to real-time fluoroscopy~     (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and~     participants and the high cost of the new and upgraded fluoroscopic equipment. In this~     study, it was designed to compare DSA and RTF for detection of intravascular penetration in~     the same participant who underwent cervical TFEB.~      The investigators prospectively examined the participants who received cervical TFEB. The~     needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media~     was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic~     contrast media was injected at the rate of 0.5 ml/sec under DSA.~   "
1266|NCT03040635|"~     This is a randomized, placebo-controlled study to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single oral doses of RO7034067 in healthy Japanese~     participants.~   "
1267|NCT03040622|"~     This study will evaluate thrombogenicity in patients undergoing left atrial appendage~     closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well~     as other bio-markers, will be measure before, during, and after WATCHMAN implantation at~     several follow up visits.~   "
1268|NCT03040609|"~     The main objective of this study is to develop and validate a visio-behavioral scale of~     visual abilities for subjects with profound multiple intellectual disabilities.~      The secondary objectives of the study are:~        -  to validate the structure of the scale.~        -  to evaluate the reproducibility of scale with the intra- and inter-examiners, and the~          influence of the different professions of examiners.~        -  to evaluate the feasibility of visio-behavioral scale.~        -  to evaluate the sensitivity to change.~        -  to study the uniformity of use of the scale depending on the type of patients (age,~          disability level, pathology).~        -  to study the prevalence of the visual disorder in profound multiple intellectual~          disabilities subjects.~   "
1269|NCT03040596|"~     Voice disorders are the most common communication disorder across the lifespan and vocal~     fold nodules are the most frequent pathology affecting voice in children. The goal of the~     present study is to determine the safety and feasibility of a short-course of inhaled~     corticosteroids in addition to standard voice therapy for treating vocal fold nodules.~   "
1270|NCT03040583|"~     The ASSESS national multi-center prospective cohort (Assessment of Systemic complications~     (Signs) and Evolution in Sjögren's Syndrome SS) was set up in 2006 thanks to a grant of~     the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively~     included consecutive patients with Primary Sjögren's Syndrome pSS fulfilling~     American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by~     the Ethics Committee of Bichat Hospital and the Commission Nationale Informatique et~     Libertés in 2006. All patients gave their informed written consent. This study was followed~     for 5 years by the programme hospitalier de recherche clinique (PHRC) and this study will be~     extended for 20 years by Société Française de Rhumatologie (SFR). On an annual basis for a~     duration of 20 years, a thorough standardized paper case report form (CRF) was filled~     prospectively by clinicians.~   "
1271|NCT03040570|"~     A feasibility study to determine if it is possible to perform a safe, adequately powered,~     and affordable multi-centre study in critically ill children comparing current practice of~     liberal targets for systemic oxygen levels with more conservative targets.~   "
1279|NCT03040466|"~     Reusable flexible ureteroscopes are widely used to treat various upper urinary tract~     diseases including urinary stones. However, they require a long turnover time between~     procedures because of the sterilization process. Moreover, repeated use of a scope~     ultimately deteriorates its image quality which leads to a high maintenance cost in the~     long-term. A disposable digital flexible ureteroscope was released in the United States in~     January 2016, offering an improved image resolution, new scope performance characteristics~     with every case, and no need for sterilization and repair. Preliminary data from our center~     has demonstrated that disposable scopes shorten operative time by 25% compared to reusable~     fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate.~     Therefore, treatment with disposable scopes may be more effective for patients and~     facilitate cost management within the hospital.~      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes~     between disposable digital, reusable fiberoptic, and reusable digital flexible~     ureteroscopes.~   "
1272|NCT03040557|"~     The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main~     cause of heel pain and functional disability. The mechanical stress, stretching of plantar~     fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP,~     especially when exposed to repetitive activities, such as walking. Another extrinsic~     etiologic factor of great influence is inadequate shoes that can lead to a deterioration and~     progression of the disease. One of the great difficulties of their conservative treatment is~     long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles~     stand out as one of the effective mechanical treatments to improve the immediate pain~     symptoms, in the short term. Other literary evidence, not specific to FP, has shown the~     benefits, the short and long term, a flexible footwear promotes more flexible feet and~     overload reduction. Objective: Verify therapeutic effect in the long term, a flexible~     footwear and low cost and orthopedic insole on the clinical aspect, functional and~     biomechanics of the gait of women with acute FP and chronic with presence of heel spur. It~     will be conducted a randomized controlled trial with blinded evaluator, in which 75 women~     with plantar fasciitis will be randomized and allocated to the intervention group with~     flexible footwear (GIC, acute n=15 and chronic=15) or the intervention group with orthopedic~     insole (GIP, acute n=15 and chronic n=15) or control group (CG, n=15). The intervention will~     have duration six months, six hours a day, seven days a week (42 hours/week). For all groups~     will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of~     two grams daily. The primary outcome will be the symptom of pain verified by visual analogue~     scale (VAS), and the secondary: the inability to areas of the feet by the total score of the~     FFI (Foot Function Index), health feet by FHSQ-Br questionnaire (Foot Health Questionnaire~     Status), the distance traveled by the six-minute walk test (6MWT), paracetamol consumption~     and the joint angles of the lower limbs, plantar pressure and ground reaction force during~     gait. The effects of time (Start, 3 and 6 months), group (GIC and GIP CG) and interaction~     (time and group) are calculated by means of ANOVA case-wise two factors. A 5% alpha to~     significant differences and Cohen coefficient for describing the size effect of the~     intervention is assumed.~   "
1273|NCT03040544|"~     Background: Laparoscopic surgical procedures have become increasingly established in~     operative medicine. They require special motor, haptic, and spatial-visual skills to perform~     the interventions safely and effectively. The basic skills are often learned in the~     operating room on the patient. This is economically inefficient and can be improved with~     regard to patient safety. Against the background of this problem, various simulators were~     developed in order to train laparoscopic basic skills outside the surgery. The Lübecker~     Toolbox (LTB) curriculum is a video-based trainer, which - unlike the other trainees on the~     market - has standardized and validated exercises with concrete targets, based on the skills~     of experts in minimally invasive surgery (MIC). Against the background of different,~     non-validated training programs and simulators with ambiguous objectives, it is not known~     how training programs and simulators improve the skills of the advanced physicians in~     performing laparoscopic-assisted operations. An evidence of effectiveness in the practice~     transfer could have a considerable relevance with regard to the integration of the training~     programs into the specialist doctoral training.~      Aim of the study: The aim of the study is to investigate whether physicians in the first~     years of further education are able to improve laparoscopic skills required to perform~     laparoscopic operations, if they have successfully completed the LTB curriculum.~      In the prospective study, the subjects are randomized into two groups, one group completing~     the LTB curriculum after the first own laparoscopic cholecystectomy and the other not. After~     2 months, both groups will perform their first laparoscopic cholecystectomy again. The~     laparoscopic video recordings will be analysed and compared using the Global Operational~     Assessment of Laparoscopic Skill (GOALS) score.~   "
1274|NCT03040531|"~     Prolonged glucocorticoid therapy affects bone fragility, cardiovascular health, glucidic and~     lipidic metabolism, thyroid and brain function. Glucocorticoid-induced osteoporosis is~     characterized by low bone turnover and fractures, which occur in 30-50% of patients.~     Glucocorticoids affect predominantly cancellous or trabecular bone, increasing the risk of~     vertebral fractures, which may be asymptomatic and occur early during the first months of~     glucocorticoid treatment. Genistein exerts biological effects by several potential~     mechanisms. Besides protective effects on bone loss, genistein reduces cardiovascular risk~     markers, improves endothelial function and ameliorates glucose and lipid metabolism. This~     study is aimed at demonstrating genistein efficacy in glucocorticoid-induced osteoporosis in~     a cohort of caucasian post-menopausal women.~   "
1275|NCT03040518|"~     In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes.~     This study looks at whether two interventions which show promise can help obese men lose~     weight and keep it off.~      INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though~     they come from other men who are also losing weight and include 'how to do it' diet and~     physical activity tips, combined with friendly humour and support.~      INTERVENTION 2: The same texts plus promising men money at the start contingent on weight~     loss achievement. The money will vary over a year according to whether weight targets are~     met. This is called an endowment incentive and is based on research showing that modest~     payment helps people change their diet and physical activity. At the 3, 6 and 12 month~     weighing appointments, men will have the option of continuing with the original weight loss~     targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5%~     at 12 months. This is to maintain motivation and hope for men who do not meet the more~     ambitious weight loss targets.~      This study examines if the texts work better with incentives than alone. Both interventions~     are delivered from a computer and have potential to reach large numbers, including men who~     don't use health services. This work is done together with obese men and a charity for men~     to help us find the best ways to deliver the interventions to as many men as possible,~     including men in difficult life situations.~      This study will examine whether it is acceptable and feasible to randomise obese men to~     three groups: texts only; texts and incentive; or to a 'control group' who wait a year and~     then get the texts for 3 months. The feasibility of recruiting 105 obese men from two~     regions of Scotland will be assessed. Half of the men will get an invitation letter from~     their GP. The other half will be approached in the community, given information about the~     study and invited to take part. Men can take part if their waist circumference is 40 inches~     and more or their Body Mass Index is 30 or higher. The study examines how long it takes to~     find 105 obese men who want to take part, how many come back to suitable venues at 3, 6 and~     12 months to get weighed and answer questions about their quality of life, lifestyle and~     motivation. At the end participants will report about their experiences of weight loss and~     of being in the study.~   "
1276|NCT03040505|"~     The aim of the study is to investigate temporal organization of future thinking in patients~     with schizophrenia. Patients and control participants will be asked to envision and briefly~     describe ten personal future events using a cue-words list. Then they will be asked to~     describe everything that came to their minds (i.e. to think aloud) while they attempted to~     determine when an event will likely occur. The investigators will compare the proportion of~     several predefined strategies mentioned by the two groups of participants to locate future~     events in time. The investigators predict that patients will envision less personal future~     events and will rely to a lesser extent on strategies to locate events in time, than control~     participants.~   "
1277|NCT03040492|"~     The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene~     polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)~     and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant~     demographic information such as physical characteristics (e.g., ethnicity), family history,~     and cancer diagnosis will be collected in order to determine if there are relationships~     between the gene polymorphisms, cancer diagnosis, and these characteristics.~   "
1278|NCT03040479|"~     This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This~     study will enroll up to 24 subjects and will include 2 hepatic impaired subject groups and~     one group of control subjects with normal hepatic function.~   "
1401|NCT03038880|"~     This is a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to~     investigate the efficacy, safety and pharmacokinetics of RO6867461 (RG7716) administered~     with extended dosing regimens in treatment-naive participants with nAMD. Only one eye will~     be chosen as the study eye.~   "
1280|NCT03040453|"~     Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not~     eligible for liver transplant or liver resection. At our Hospital two different methods are~     used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible~     electroporation, where the tumor cells are exposed to an electrical field and nano-pores are~     formed in the cell membranes and the cells go into apoptosis (programed cell death).~      Previous studies have shown effects on the immune system after ablative therapies.~      The purpose of this study is to compare the immunological response after the wo different~     methods of killing the tumor cells.~   "
1281|NCT03040440|"~     The purpose of this study was to compare the cuff pressure between cylindrical and~     TaperGuard endotracheal tube during laparoscopic cholecystectomy.~   "
1282|NCT03040427|"~     The investigators postulate that F-18 florbetapir will show improved detection of cardiac~     amyloidosis over conventional non-invasive imaging techniques, particularly in early~     disease.~   "
1283|NCT03040414|"~     Adolescents and young adults with type 1 diabetes often have a difficult time achieving good~     glucose control which is so important in reducing the risk for diabetes complications.~     Despite the use of multiple daily injections or insulin pumps and glucose sensors there is~     still a need for many individuals to further improve glucose levels but do so without~     causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with~     diabetes. Today an insulin pump can receive glucose readings from a continuous glucose~     monitor and adjust the insulin delivery up or down in an attempt to keep glucose levels in a~     more optimal range. These systems are called hybrid closed loop meaning while much of the~     insulin delivery is automated the patient still interacts regularly with the system~     particularly to help determine the insulin dose to deliver to cover a meal. Results of early~     studies using hybrid closed loop systems in adolescents and adults with type 1 diabetes are~     very encouraging. This study will compare the FDA-approved hybrid closed loop system by~     Medtronic (670G) to a next-generation Medtronic system programmed to further improve glucose~     control, particularly around mealtime, which is currently one of the biggest challenges with~     all hybrid closed loop systems. One hundred adolescents and young adults (ages 14-30) will~     test each system for three months in a crossover fashion. The investigators will compare how~     effective each hybrid closed loop system is at preventing high blood glucose readings during~     day. The investigators will also evaluate the safety of each system and how participants~     adjust to the daily use of the technology.~   "
1284|NCT03040401|"~     Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2~     (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6~     week rest periods.~      All subjects will be assigned to one of three consecutive cohorts, each comprising five~     patients.~      Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the~     assessment of short-term impact of HDC alone on clonal and immunological markers. For all~     remaining cycles the combination of HDC and IL-2 will be given.~      Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all~     patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical~     response and toxicity will be evaluated. On the basis of the results for the first 4 cycles~     of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the~     combination of HDC/IL-2 or HDC alone.~      In case of a beneficial response* after 4 cycles, treatment may be continued to a total of~     10 cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.~      IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during~     treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or~     a family member/significant other will be instructed to administer injections of both study~     drugs to allow safe treatment at home.~   "
1285|NCT03040388|"~     The main purpose of this study is to determine whether electroconvulsive therapy (ECT)~     causes any structural or functional brain changes and thus indicating its mechanism of~     action. The second aim is to find predictors of an immediate response, sustained remission,~     relapse and side-effects. Thirdly, this study aims to explore whether ECT causes any changes~     in blood-brain barriers permeability and whether these changes correlate to memory problems.~     The fourth objective is to examine whether ECT causes any brain tissue damage.~   "
1286|NCT03040375|"~     Undernutrition and poor cognitive development affect many children under 5 in developing~     countries, who are exposed to multiple risk factors including poverty, malnutrition, poor~     health, and unstimulating home environments. The optimum development and growth of young~     children requires affection and responsiveness from the mother/caregiver, cognitive~     stimulation, good nutrition and infection control. In Bangladesh, stimulation at home is~     generally poor and contributes to children's poorer development. It is important to show~     that psychosocial stimulation programmes through home visits integrated into the feeding~     programmes can benefit children's growth and development. This study will help to fill this~     evidence gap about effective interventions to improve infant and young child growth and~     development in Bangladesh. Considering the high prevalence of undernutrition and low~     prevalence of stimulating environments in Bangladesh, it is important to show evidence that~     integrating infant feeding counselling and psychosocial stimulation activities result in~     optimum child growth & development. To determine if combined infant feeding counselling and~     psychosocial stimulation programme (promoting mothers positive parenting) starting in the~     3rd trimester of pregnancy, further improves: children's cognitive, motor and language~     development along with growth and mothers' child rearing and child-feeding knowledge and~     practices compared to peer counselling alone or usual health messages only. We used a~     community-based CRCT to examine the impact of a peer counselling infant feeding education~     program with psychosocial stimulation starting in the third trimester of pregnancy to one~     year after delivery, to improve child growth and cognition, language, behaviour and~     psychomotor development compared to a control group receiving usual health messages. The~     outcome assessments were made on a cohort of infant-mother dyads measured at baseline and at~     follow up visits. Outcome assessments were conducted with all the mother-infant pairs~     recruited in the community clusters in the study, with an expected total of 334~     mother-infant dyads (167 in each treatment group).The main outcomes are children's growth,~     cognition, language, behaviour and psychomotor development~   "
1287|NCT03040362|"~     This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study~     of [14C]-lasmiditan administered as a 200-mg (approximately 100 µCi) oral solution to 8~     healthy male and female subjects, following at least a 10 hour fast from food to assess the~     pharmacokinetics (PK), metabolism, and routes and extent of elimination of a single oral~     dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in healthy male and female subjects.~   "
1297|NCT03040232|"~     The purpose of this study is to identify predictors of future injury and disability~     following LPD. The investigators' long term goal is to improve longitudinal outcomes of~     athletes with LPD following surgical and non-surgical management. Currently, there is~     limited information available to clinicians regarding appropriate criteria for returning~     athletes to sports participation following LPD. The evidence produced by this study will~     provide necessary information to develop appropriate rehabilitation strategies that may~     reduce the risk for future patellar instability and associated patellofemoral joint~     dysfunction and pain.~   "
1298|NCT03040219|"~     Folic acid as a appetizer in organic and inorganic faltering growth~   "
1288|NCT03040349|"~     The overall aim of the TiTAN Greece & Cyprus project is to expand the Global Bridges Tobacco~     Treatment Training Network in the WHO Europe region through a focus on primary health care~     providers in Greece and Cyprus. A robust evaluation will be conducted alongside the TiTAN~     program. A pre-post evaluation will be used to examine the impact on the TiTAN program on:~        1. Provider engagement (number of providers attending training), number of local~          champions;~        2. Provider knowledge, beliefs, perceived behavioral control, and intentions related to~          the delivery of tobacco treatment;~        3. Rates of evidence-based tobacco treatments (5As) are delivered to patients who smoke;~        4. Provider satisfaction with training program, resources, and network outreach activity~          and areas for improvement; and~        5. Estimates on the impact on patient-level outcomes including number of patient quit~          smoking at 1 and 3-month follow-up.~      All PHC providers will be surveyed before and after the intervention program is delivered.~     We will randomly select a sub-sample of providers and will survey patients from their~     practice before and after the intervention program in order to validate changes in 5As~     delivery. Qualitative interviews will be completed with a sub-sample of providers at the end~     of year 1.~   "
1289|NCT03040336|"~     Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran~     population grows older and more frail, there is a critical need to identify effective~     strategies for reducing surgical risks for these patients. Prior research shows that~     inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and~     improve outcomes by building strength and improving nutrition. We believe that similar~     improvements may be obtained by using similar interventions before surgery to~     prehabilitate patients' capacity to tolerate the stress of surgery. The proposed research~     will examine the feasibility of a new, prehabilitation intervention aimed at improving~     postoperative surgical outcomes through preoperative exercise training and nutritional~     supplementation. Findings from the study will inform the design of a larger randomized~     controlled trial of the prehabilitation intervention. If proven effective, prehabilitation~     could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery~     each year.~   "
1290|NCT03040323|"~     We plan to compare complication and success rates between two methods of ultrasound guidance~     for biopsy of liver lesions, contrast-enhanced and our current protocol without contrast.~   "
1291|NCT03040310|"~     The prevalence and disability associated with discogenic low back pain are significant, and~     there is a general lack of widely accepted conservative treatments for the condition. A~     majority of previous studies that have assessed the efficacy of self-directed exercise-based~     rehabilitation programs did not include comprehensive metrics to confirm whether~     participants actually participated in the exercises prescribed. In this pilot study, the~     investigators hope to determine whether proxies of compliance with a daily, self-directed~     rehabilitation program for discogenic low back pain are correlated with participant-reported~     improvements in pain and function. The feasibility of a mobile interface designed to help~     patients with chronic low back pain track the daily management of their conditions will also~     be evaluated.~   "
1292|NCT03040297|"~     The study investigates if there are benefits (better oxygenation, minimized work of breath)~     from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to~     provide respiratory support in tracheostomized patients and avoid mechanical ventilation.~   "
1293|NCT03040284|"~     In patients at risk of increased intracranial pressure (ICP), ICP measurements require~     invasive transducers, usually with insertion of a catheter into the cranium, or through a~     spinal tap. These invasive modalities involve risks and pain and they can be done only in~     specialized care units, with a high associated cost.~      A novel method for detecting changes in ICP has developed recently. The auditory hair cells~     emit sounds and electric signals in response to sound, which can be easily detected and~     measured non-invasively with the help of a microphone probe placed in the external ear canal~     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)~     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within~     seconds.~      The evaluation of intracranial hypertension by increased ICP (invasive) is not~     systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using~     routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in~     combination with a standard imaging method (TDM).~      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another~     disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes~     patient clinical worsening and / or imaging.~   "
1294|NCT03040271|"~     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to~     promote healthy eating and physical activity with school children ages 9 to 11 years in~     Lebanon.~   "
1295|NCT03040258|"~     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to~     promote healthy eating and physical activity with school children ages 9 to 11 years in~     Lebanon.~   "
1296|NCT03040245|"~     Whiplash trauma and the resulting whiplash associated disorders have been the subject of~     much attention in the scientific literature and remain a major public health problem.~      The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder~     pain, as well as visual impairment. It is not unusual for neck pain to become chronic, and~     when this occurs, there may be serious consequences on a social, professional and financial~     level.~      Even though the role of the initial episode should not be ignored, progression to chronic~     pain is probably multifactorial and, like non-specific low back pain, psycho-social factors,~     and in particular patient fears and belief, seem to play a relevant role, as do~     environmental factors. The professional consensus is that it is useful to provide targeted~     information at an early stage in whiplash settings in order to reduce mistaken fears and~     beliefs. A preliminary study enabled the investigators to validate a French version of an~     information booklet that draws on validated data from evidence-based medicine. The booklet~     was Le guide du coup de fouet cervical, the French version of The Whiplash Book. This~     study showed that fears and beliefs were considerably high in a population without neck~     problems who were working in hospitals. It also revealed that simply providing information~     could help lessen them.~      Management following whiplash injury can make use of the recommendations as published in the~     literature. Healthcare professionals must reassure and educate their patients that~     post-traumatic pain is normal, and that they need to remain active and maintain physical~     activity in order to improve their prognosis.~      Only very few studies have evaluated the adherence of physicians or healthcare professionals~     to the guidelines and to ways of changing their approach to treatment.~      The main aim of this study was to determine what fears and beliefs physicians have about the~     consequences of whiplash. The secondary aim was to measure the impact of a validated~     information booklet on emergency physicians' approach to management following a whiplash~     injury.~   "
1443|NCT03038321|"~     Compare the different supposed clinical treatment of side effects associated with~     intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs~     lornoxicam (NSAID)~   "
1300|NCT03040193|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of~     various bronchopulmonary diseases. Most patients tolerate the procedure well although cough~     is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy~     would be significantly improved with control of cough. Use of sedation during bronchoscopy~     has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy~     is routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of lignocaine delivered with the nebulized route during~     awake flexible bronchoscopy. This study would help to determine the utility of nebulized~     lignocaine in airway anaesthesia during flexible bronchoscopy.~   "
1301|NCT03040180|"~     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant~     electrochemotherapy on locally advanced rectal cancer (UICC II-III) in an intended curative~     clinical setting, using an endoscopic electroporation device (EndoVE).~   "
1302|NCT03040167|"~     The pectoral block is a recently developed regional anesthetic technique that can be used~     for the treatment of postoperative pain after breast surgery. Injection of local anesthetic~     between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.~     This block has not been well characterized in terms of its blocking effects on motor and~     sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical~     trial is divided into two sections: a volunteer study and a patient study.~      For the volunteer study, the aim is to assess the sensory territory affected by injection of~     local anesthetics through a PEC 1 block and to assess motor function in terms of strength of~     adduction of the affected limb using a dynamometer.~      In a prospective, randomized, controlled and double blind study, the aim is to assess the~     postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral~     breast augmentation surgery.~   "
1303|NCT03040154|"~     The objective of this community-based randomized controlled trial is to evaluate the~     outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video)~     aimed at promoting the participation of Filipino parents and grandparents in an~     evidence-based preventive parenting intervention.~   "
1304|NCT03040141|"~     This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir~     vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen~     support.~   "
1305|NCT03040128|"~     To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral~     hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for~     (1) safety/ tolerability and (2) evaluate for clinical efficacy~   "
1306|NCT03040115|"~     The aim of this study is to conduct survey-based assessments for the safety of air travel in~     patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the~     clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation~     website. Patients will have access to the questionnaire via REDCap (an online data~     management system) and each patient will be provided with a link to complete the survey. The~     investigators plan on enrolling approximately 100 patients with BHD for the purpose of this~     study. Secondary aims of this study include further characterization of the clinical aspects~     of disease and to establish a contact registry for these patients, in order to facilitate~     future studies.~   "
1307|NCT03040102|"~     The purpose of this research study is to compare two ways to educate patients with cancer~     and their caregivers about hospice care services~   "
1308|NCT03040089|"~     This is a prospective, multi-center, split-face, controlled clinical trial that aims to~     investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet~     laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial~     will be performed by two Korean institutions on 45 subjects.~   "
1309|NCT03040076|"~     The purpose of this study to test a computerized treatment designed to help people with high~     levels of emotional eating, which is when people eat to cope with negative emotions and/or~     stressful situations. The investigators are interested in comparing two different ways of~     coping with negative emotions, relaxation training or training in how to think differently~     about such situations. Additionally, the researchers' study seeks to understand more about~     the psychological factors that may contribute to someone having difficulty with emotional~     eating.~   "
1310|NCT03040063|"~     Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral~     flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and~     subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg~     blood stream - will lead to a comparable or better outcome in treatment of patients with the~     popliteal artery aneurysm and acute critical limb ischaemia, compared to currently~     prevailing use of surgical treatment.~   "
1311|NCT03040050|"~     The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive~     either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or~     standard of care (control) prostate biopsy. The subjects will have a rectal culture swab~     performed prior to the prostate biopsy. One rectal culture swab will be used for rapid~     multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The~     subjects randomized to the intervention group will have the qPCR results shared with the~     physician to determine if additional standard of care antibiotics are needed at time of~     standard of care prostate biopsy. The subjects randomized to the control group will not have~     the qPCR results shared with the physician to determine if additional standard of care~     antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days~     after the prostate biopsy, the research staff will conduct a chart review and/or telephone~     call to ask about any prostate biopsy infections and complications.~   "
1312|NCT03040037|"~     This is a prospective registry of atrial fibrillation cryoablation in the Russian~     Federation. This study is observational, prospective, multicenter, open-label~   "
1313|NCT03040024|"~     The goal of this prospective randomized double blinded placebo controlled study is to~     investigate if a single dose of ketamine in addition to standard anesthesia will reduce the~     risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on~     post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will~     be utilized during the surgical procedure to evaluate its potential as a possible predictive~     device for delirium.~   "
1314|NCT03040011|"~     To test the hypothesis that preoperative injections along the levator ani muscles and~     pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical~     reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total~     of 75 women will be performed.~      The study population will be adult women (>18 years of age) with uterovaginal or vaginal~     vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery~     which includes an apical support procedure. Participants will be enrolled prior to surgery.~     The procedure will involved four injection sites: the bilateral levator ani muscles via a~     transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random~     assignment will occur to one of three study arms: combined arm (20 milliliters~     bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm~     (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20~     milliliters saline divided between the 4 injection sites).~   "
1315|NCT03039998|"~     The main objective of project is to compare validity of sampling methods performed routinely~     (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological~     agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to~     bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis~     using bronchial secretion sampling in HAP diagnostics and detection of the most common~     etiological agents in patients with HAP are other priorities of the project. Aiming to~     confirm or exclude the diagnosis of HAP, determine the sources and possible routes of~     bacterial pathogens transmission molecular biology analysis of etiological agents is~     performed. Finally, percentage of HAP etiological agents resistant to initial empiric~     antibiotic therapy will be observed.~   "
1316|NCT03039985|"~     The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns~     in patients with or without bruxism.~   "
1317|NCT03039972|"~     Cross-sectional evaluation of hydration status and kidney function in patients with~     pulmonary hypertension~   "
1318|NCT03039959|"~     Evaluation of renal function in patients with pulmonary hypertension undergoing right heart~     catheterization~   "
1319|NCT03039946|"~     The aim of this study is to compare hemodynamic variables and outcome in patients undergoing~     laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an~     automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow~     monitoring or a restrictive fluid therapy of 4ml/kg/h.~   "
1320|NCT03039933|"~     The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)~     is to address the critical need of identifying and decreasing fear of hypoglycemia, which~     will be accomplished by conducting a pilot randomized clinical trial to evaluate the~     efficacy of Blood Glucose Awareness Training, which has been adapted for, but never~     evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.~   "
1321|NCT03039920|"~     Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine~     its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO)~     concentration, both acutely and after 1 month of use.~   "
1322|NCT03039907|"~     The main purpose of this study is to examine the factors that allow patients that undergo~     total knee arthroplasty to return to recreational sports and/or work activities, and to~     achieve recommended physical activity levels.~   "
1323|NCT03039894|"~     School engagement is associated with children's long-term health and success. Students who~     are engaged in school have better academic outcomes and lower rates of risky health~     behaviors. The investigators partnered with Alliance College-Ready Middle Academy 12~     (Alliance 12), a charter school in Los Angeles, to develop the gradebook game, an~     intervention that aims to improve academic achievement, peer support, and school engagement.~     The game involves frequent feedback on students' school performance, team-based competition~     aligned with the school mission, and peer mentorship by team captains. For the 2016-2017~     academic year, the investigators will assist Alliance 12 in implementing the gradebook game~     in two of its five 6th grade homerooms. The investigators plan to evaluate whether the game,~     as hypothesized, is effective in increasing school engagement, including academic~     performance and positive behavior.~      In order to conduct this evaluation, the investigators plan to enroll 6th grade students by~     obtaining parental consent and student assent at the beginning of the school year. Students~     will be enrolled for the entire 2016-2017 academic year. All study procedures except for~     parental recruitment will occur during the school day. Participation in the study involves~     completing 2 student surveys and permitting the collection and analysis of student data from~     the online gradebook and behavior system. The investigators plan to use an interrupted time~     series design that will analyze student gradebook and behavior data at multiple time points~     before and after the game starts. The surveys will be completed at the beginning and end of~     the study period. Surveys will include measures of self-reported school engagement, age,~     gender, race/ethnicity, primary language at home, social and emotional well-being, social~     status, and peer support. Surveys will be administered via iPad.~      If the pilot study demonstrates that the gradebook game is effective in promoting school~     engagement and academic achievement, it is anticipated that it could be widely adopted and~     more rigorously evaluated in a larger study. Because the gradebook game is a low-resource~     intervention, it could easily and sustainably be replicated, providing a much-needed tool~     for schools with low engagement.~   "
1324|NCT03039881|"~     This observational study investigates the validity and utility of a new, non-significant~     risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients~     undergoing elective surgery under general anesthesia. The study patients will be monitored~     before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for~     the first post-operative night. The physiologic data will not be used or influence the~     standard of care for subjects. It is anticipated that this monitor may be able to improve~     perioperative care in the future.~   "
1325|NCT03039868|"~     SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer.~   "
1326|NCT03039855|"~     To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve~     with the Tiara Transapical Delivery System.~   "
1342|NCT03039647|"~     Premature and accelerated brain aging trajectories have been observed among people with~     metabolic dysfunction, but mechanisms of these altered trajectories are not understood.~     Insulin resistance (IR) is known to change with age and affect cognition in older and~     elderly adults as well as in patients with mood disorders. The main purpose of the study is~     to describe the developmental trajectory of cognitive and neural biomarkers across the~     spectrum of metabolic dysfunction in overweight/obese adults younger than 50 years of age.~     The innovative study design will allow the investigators to examine cognitive outcome~     development over a 25-year span without an investment into the longitudinal observation of~     changes in cognition and neural function.~   "
1343|NCT03039634|"~     This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical~     silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with~     a laser for the treatment of Acne Vulgaris.~   "
1327|NCT03039842|"~     This is a research clinical trial of double-blind, stratified randomized, parallel group,~     two-centre study. It will be conducted in a total of 250~300 male and female subjects from~     the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects~     will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric~     evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion~     and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place~     will commence at randomization for while patients continue open-label valproate. Subjects~     will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1)~     30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3)~     dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine~     medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or~     insomnia during the study. For the consideration of the less influence to immune-system,~     resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the~     treatment response and side effect to clarify the curative effect of DM and memantine add-on~     therapy to valproate in the treatment of bipolar disorders. This study is being performed to~     investigate the possibly significant beneficial effects on the subtypes of bipolar disorders~     psychopathology.~   "
1328|NCT03039829|"~     This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses~     will differentially affect hemodynamic variables compared to a placebo.~   "
1329|NCT03039816|"~     Background: A nasally applied cellulose powder is increasingly used in many countries as a~     remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children~     showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen~     counts. The present study in grass pollen-allergic adults used the same basic design.~     Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients~     with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were~     used as reminders of treatment and reporting of symptom scores.~   "
1330|NCT03039803|"~     In recent decades, the rate of cesarean section delivery has steadily increased worldwide~     ranging at 30% of deliveries, thus long-term risks after cesarean section need to be~     evaluated. Postoperative risks include, among others, uterine scar rupture and placental~     complications such as placenta previa and accreta- complications, which are possibly~     associated with uterine scar dehiscence.~      The prevalence of lower-segment uterine scar deficiency has previously been described as~     63%. One recent systematic review and meta analysis investigated closure techniques of low~     transverse cesarean. No significant difference in risk of uterine scar defect comparing~     single layer versus double layer closure could be detected (RR 0.53), whereas in women with~     single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,~     the authors do conclude that data is insufficient to determine the risk of uterine rupture,~     dehiscence or gynecological outcomes due to insufficient power of available studies. A~     recently published Randomized Controlled Trial concluded that double-layer closure with~     unlocked first layer showed a better scar healing than locked single layer.~      The investigators main objective is to identify if single-layer suture of the uterus during~     cesarean section results in a higher rate of cesarean scar deficiency than double-layer~     suture.~      Interventions~      Single- layer versus double- layer uterine closure Two different techniques of uterine~     closure in cesarean section will be compared: single- layer versus double- layer continuous~     uterotomy suture.~      Standardized transvaginal sonography~      Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound~     machine used for all examinations is GE Voluson E10.~      Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after~     CS (yes/no).~      Secondary outcome: Myometrial thickness at the site of uterine scar (mm).~   "
1331|NCT03039790|"~     The purpose of this study is to evaluate descriptively the long-term immunogenicity of at~     least 1 Norovirus GI.1/GII.4 bivalent VLP vaccine (NoV) vaccine administration.~   "
1332|NCT03039777|"~     Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI).~     Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its~     role as a surrogacy marker in CRBSI.~   "
1333|NCT03039764|"~     To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly~     diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their~     hand in supplementation with conventional occupational therapy to assess whether it improves~     motor function and speed recovery during inpatient rehabilitation versus conventional~     occupational therapy alone. Also, what impact does this have on quality of life.~   "
1334|NCT03039751|"~     The purpose of the study is to evaluate the safety and efficacy of catheter mediated~     endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative~     gene transfer in patients with refractory angina to whom revascularisation cannot be~     performed.~   "
1335|NCT03039738|"~     The purpose of the study is to evaluate the impact of surveillance monitoring versus~     telemetry monitoring on clinical, healthcare economics, resource utilization, and~     qualitative outcomes.~   "
1336|NCT03039725|"~     Retrospective study to assess a single Clinic on Immunization Practices (ACIP)~     recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV~     and pneumococcal disease~   "
1337|NCT03039712|"~     The primary purpose of the study is to meet the CMS mandated Coverage with Evidence~     Development requirement in the National Coverage Determination for Leadless Pacemakers as~     they apply to Medtronic Micra devices. The study uses administrative claims data of the~     Medicare population implanted with single-chamber ventricular pacemakers~   "
1338|NCT03039699|"~     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon~     in the treatment of viral intestinal infections in inpatient children~   "
1339|NCT03039686|"~     This is a multi-center, randomized, double-blind, placebo-controlled study to assess the~     efficacy, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory~     boys with Duchenne Muscular Dystrophy (DMD).~   "
1340|NCT03039673|"~     MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1),~     placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2~     safety and clinical efficacy on survival and functional decline in newly diagnosed ALS~     patients treated for 18 months. Randomization will be stratified according to (i) country (n~     = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).~      The primary objective to evaluate the clinical efficacy and safety of the experimental drug~     (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that~     modifying immune responses through the enhancement of regulatory T cells modifies the rate~     of ALS disease progression.~   "
1341|NCT03039660|"~     This study aims to investigate the feasibility and efficacy of online student wellness~     courses for improving medical student mental health and well-being.~   "
11125|NCT02911571|"~     This will be a prospective, case-only, study to measure the impact of MMprofiler on~     treatment intention decisions in active Multiple Myeloma patients.~   "
1345|NCT03039608|"~     The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial~     esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently~     these years especially in Asian countries. However, besides of perforation and bleeding,~     another complication postoperative esophageal stricture is frequently observed after the~     removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative~     stricture substantially decreases the patient's quality of life, requiring further therapy.~     Although the exact incidence is unknown, esophageal stricture is supposed to be related to~     the extent of the circumference being resected. In previous study by Ono et al，it is~     reported that 90% of patients with lesions of circumferential extension of more than~     three-fourths experienced postoperative stricture after esophageal ESD. There were some~     reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral~     prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only~     collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture~     formation. Some studies reveled that just oral prednisolone oral is effective option for the~     prevention of post-ESD stricture. However, most of the reported studies were non RCTs with~     small sample. In the primary study, the investigators search a new method of combination of~     both oral and local injection to prevent esophageal stricture，as a result，stricture at 8~     weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of~     34 in the corticosteroid group. Unfortunately，the study was also retrospective. So, the~     investigators plan to undertake a prospective, randomized controlled trial to evaluate the~     prophylactic effects of combination of local steroid injection with oral steroid~     administration for esophageal stenoses complicating extensive ESD.~   "
1346|NCT03039595|"~     Early rectal cancer can be removed by minimally-invasive surgery, and the standard~     pathological assessment of the removed tumour gives valuable information about how advanced~     the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and~     patient can decide on the most appropriate further treatment and follow-up. However there is~     still much uncertainty in these predictions about recurrence. This study will assess two~     further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results~     with outcome. This will determine whether these two tests provide additional value in~     predicting outcome. If so, clinicians would be better able to advise patients with early~     rectal cancer about their prognosis and further management.~   "
1347|NCT03039582|"~     Anovaginal distance measured by palpation and perineal ultrasound are similar.~   "
1348|NCT03039569|"~     In this proposed project the investigators will (1) examine the impact of diabetes~     self-management education using text messaging on increasing awareness of CVD risk~     perception, dietary intake, physical activity, diabetes self-management, and quality of life~     among adults with type 2 diabetes; and (2) determine whether diabetes self-management~     education using text messages improve HA1C among adults with Type 2 diabetes. The study~     sample will include 100 adult type 2 diabetes patients (30 years or older). The recruited~     adult type 2 diabetes patients will be randomly assigned into the intervention group (50~     participants) and control group (50 participants). The intervention group will receive 3~     messages weekly consisting of nutrition education and diabetes self-management information~     and skills for 3 months (12 weeks). The messages will consist of information on how to~     increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the~     availability of fruits and vegetables and reduce high-fat and sugary foods in the home,~     strategies to increase diabetes self-management skills, and awareness of cardiovascular~     disease risk perception and knowledge. The text messages will be derived from the American~     Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy~     Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise) Text~     messages will be positive and motivating and will include a link to a specific AADE7 handout~     that allows participants to open and retrieve the specific AADE7 handout. The control group~     will not receive text messages. The participants (both intervention and control group) will~     complete surveys at baseline (before study begins) and at the conclusion of the study (at~     three month of the intervention) about their dietary and lifestyle habits, diabetes~     self-care management, awareness of cardiovascular diseases, home food environment and~     quality of life. We will also collect patient's self-report Hemoglobin A1C values at~     baseline and at the conclusion of the study (at three month of the intervention). If test~     effective, the proposed text messaging intervention will help type 2 diabetes patients to~     manage diabetes and have a healthier lifestyle.~   "
1349|NCT03039556|"~     This study investigates the effects of two weeks of reduced daily ambulation and a~     subsequent return to normal physical activity on metabolic health of older adults.~   "
1350|NCT03039543|"~     Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the~     mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia~     for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and~     the use of sugammadex as a reversal agent may be associated with better endoscopic surgical~     condition and recovery profile compared with moderate NMB during TURB.~      This study was designed to compare patients with deep neuromuscular blockade (NMB) with~     moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical~     condition and postoperative recovery.~   "
1351|NCT03039530|"~     Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have~     profound effects on mothers, their children, and their families. The cost of one case of PPD~     exceeds $150,000, a significant proportion of which is related to its impact on offspring.~     However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer~     than 15% of women receiving care. While Public Health Units have played an important role in~     PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver~     evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group~     format is effective for treating depression in the perinatal period, and as PHNs are often~     the first point of contact for women experiencing PPD, with specialized training it is~     likely that they can deliver high-quality CBT.~      The primary objective of this study is to determine if PHNs can be trained to deliver group~     Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence,~     improve mother-infant attachment and parenting and optimize infant emotional functioning.~   "
1352|NCT03039517|"~     This is a two arm, prospective, single center, randomized clinical trial. Subjects will be~     randomly assigned into one of two groups using block randomization technique in a 1:1 ratio.~     The control group will receive care using elastic compression stocking and the intervention~     group will use the ACTitouch device. Stratified randomization will occur based on whether~     the Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed~     for 2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.~   "
1353|NCT03039504|"~     This is a randomized, double blind, placebo-controlled, comparative, prospective study~     (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men~     with mild to moderate erectile dysfunction.~   "
1385|NCT03039088|"~     This is a prospective observational national (France) study with 2 visits 3 months apart~     (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is~     500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF~     alpha blocker.~      The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on~     the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and~     pre-exposed patients.~   "
1386|NCT03039075|"~     Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is~     approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are~     equal to Glucophage is unclear.~   "
1387|NCT03039062|"~     This is an open , multicenter, interventional clinical trial to conform the role of of~     miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.~   "
1354|NCT03039491|"~     The investigators hypothesized that pneumococcal vaccination with either the 23-valent~     pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent~     pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar~     antibody levels/functional antibody activity and induce similar pneumococcal polysaccharide~     (PPS)-specific B cell response in HIV positive individuals > 50 years of age, HIV positive~     individuals 21-40 years of age as compared to HIV negative > 50 years of age. The~     investigators immunized the study groups HIV+ persons >50, HIV+ persons 21-40 and controls~     (HIV negative) with PCV 13 followed by PPV23 and HIV>50 with PPV alone and examined immune~     responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide~     specific ELISA and opsonophagocytic assays (OPA). Pre- and post-immunization peripheral~     blood samples were obtained. Extensive B cell phenotype analysis using fluorescent~     antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated~     with antibody levels and OPA and compared to populations immunized with PPV~   "
1355|NCT03039478|"~     Xylitol and erythritol have become increasingly popular as sugar substitutes in the food~     industry. Both substances are freely available. While glucose ingestion stimulates satiation~     hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as~     aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g~     xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation~     hormones and induces a significant retardation in gastric emptying. The concentrations used~     to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating~     and diarrhea in 60-70% of all subjects two hours after administration. The aim of the~     present study is to find an effective concentration of xylitol and erythritol still~     stimulating satiation hormone release without any gastrointestinal adverse events.~   "
1356|NCT03039465|"~     This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a~     novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy~     patients. 30 patients will be enrolled as an inpatient or outpatient.~      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and~     trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have~     undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP~     insertion would be recruited to the study. Insertion of the TEP will be done in primary~     setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be~     evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the~     procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same~     day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.~     All the patients will be evaluated clinically for a fluid leak (through and around the TEP)~     on the same days of voice analysis by giving test feeds under supervision.~   "
1357|NCT03039452|"~     Purpose: The purpose of this study will be to examine the feasibility and acceptability of a~     6-week high intensity interval training (HIIT) program in patients with knee OA symptoms~     ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body~     metabolism induced by 6-weeks of HIIT.~      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA~      Procedures (methods): All participants will be assigned to the single-arm of the study in~     which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will~     be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,~     feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary~     outcomes will include whole body metabolism markers, inflammation, and a set of physical~     function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory~     fitness, isometric knee extensor and flexor strength (factors associated with physical~     function and symptomatic knee OA progression), and body composition.~   "
1358|NCT03039439|"~     This is a pilot biomarker study designed to compare frequencies of mutations between groups~     of malignant, benign and normal tissue or blood of patients with parathyroid disease and~     identify the potential genes showing molecular aberrations as other types of cancer.~   "
1359|NCT03039426|"~     This randomized controlled trial, compared postoperative pain score in patient undergoing~     cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and~     diclofenac intramuscular injection~   "
1360|NCT03039413|"~     This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography~     (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing~     surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor~     cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect~     urothelial cancer.~   "
1361|NCT03039400|"~     Physical activity is a crucial component to wellness and is associated with multiple health~     benefits. Persons with MS may find it challenging to participate in regular physical~     activity or exercise, which is activity done to improve health and/or fitness. This research~     will test an innovative web-based intervention to help persons with moderate-to-severe~     disability manage their condition through a maintenance exercise program with specialized~     physiotherapist guidance and support. The researchers will examine adherence to the~     web-based physiotherapy program compared to standard physiotherapy care. Forty-five people~     with MS will be randomly assigned to the web group or standard care group at a rate of 2:1.~     Participants in the web group will receive supported and individualized web-based~     physiotherapy. Participants in the standard care group will receive a written exercise~     program. Regular participation (adherence) in the exercise programs will be evaluated in~     both groups over six months. The research will also examine participant satisfaction with~     the programs, safety, MS symptoms, and physical function. A web-based approach may be widely~     accessible to persons with MS in their own homes and could support long-term participation~     in physical activity important to wellness.~   "
1388|NCT03039049|"~     Purpose:The aim of this project is to prospectively determine whether a single dose of~     GnRH-agonist administered at the time of implantation increases or not the reproductive~     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm~     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic~     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.~   "
1444|NCT03038308|"~     The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist~     ropinirole for the treatment of hyperprolactinemia in patients with idiopathic~     hyperprolactinemia and prolactinomas.~   "
1362|NCT03039387|"~     Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies~     (ERS) are both central characteristics of major depression. Both are associated with reduced~     activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current~     stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the~     cortical excitability. The goal of this randomized, sham-controlled, double blind clinical~     trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC~     and ERS in depressed patients compared to healthy subjects. Overall, the study will include~     44 participants (22 depressed Patients and 22 healthy subjects). Each participant will~     complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other~     session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting~     phase by means of a questionnaire and psychophysiological measures (heart rate variability).~     The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use~     of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall~     this experiment will provide new and reliable data for the development of new treatment~     methods.~   "
1363|NCT03039374|"~     There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in~     Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter~     lesion after birth can be challenging the total amount of women having obtained a sphincter~     lesion could be even grater.~      The aim of our study is to compare different tools in the diagnosis of obstetric anal~     sphincter injury. In doing so we hope to achieve early diagnosis of this pathology and thus~     facilitate early treatment of a possible sphincter defect.~   "
1364|NCT03039361|"~     The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD~     symptoms in veterans with PTSD as compared with existing care.~      The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms~     following participation in a 6-week Equine Assisted Psychotherapy program.~   "
1365|NCT03039348|"~     The purpose of this study is to investigate the factors influencing the decision about~     breast reconstruction after breast amputation for breast cancer.~      The study will be conducted at the University Hospital in Brussels using only a~     questionnaire. The results might help us to evaluate and improve the satisfaction among~     patients about the received information and guidance.~   "
1366|NCT03039335|"~     The objective of this study is to prospectively assess whether there is any interval between~     first symptom and initial diagnosis that is experienced by patients with newly diagnosed~     alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is~     associated with worsened clinical status at the time of initial diagnosis.~   "
1367|NCT03039322|"~     This case-control study was conducted on 90 patients who were equally divided into two~     groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical~     or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed~     to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured~     using ELISA technique~   "
1368|NCT03039309|"~     Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of~     early gastrointestinal neoplasia.~   "
1369|NCT03039296|"~     In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive~     therapy should be examined in (approximately 150) adult patients with low back pain positive~     for facet joint pain component.~   "
1370|NCT03039283|"~     The aim of this retrospective study is to collect and assess hearing performance data that~     have been measured by five clinics in Germany as part of their clinical routine in~     recipients implanted with a commercial CI532.~   "
1371|NCT03039270|"~     This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted~     aiming to assess the absolute risk of sensitivity with and without sonic activation of a~     desensitizing gel previously to the in-office bleaching in adults.~   "
1372|NCT03039257|"~     The primary objective of this study is to establish that single dose vitamin A~     supplementation is feasible and safe in pediatric and young adult bone marrow transplant~     recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.~   "
1373|NCT03039244|"~     The study proposes to assess the effect of multiple applications of antimicrobial~     Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in~     smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic~     periodontitis will be treated in a split-mouth design study to either aPDT associated with~     scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light~     source with 690 nm wavelength associated with a phenothiazine photosensitizer. The~     applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be~     monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding~     on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after~     the (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days~     after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA~     checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0,~     14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor~     Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be~     evaluated at baseline. Data obtained will be statistically analyzed.~   "
1374|NCT03039231|"~     This study will test the efficacy of the Freespira Breathing System in adults with post~     traumatic stress disorder (PTSD).~   "
1375|NCT03039218|"~     This protocol allows for treatment of 100 men in two groups (placebo and active treatment)~     of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile~     dysfunction of at least 6 months duration with low intensity extracorporeal shock wave~     therapy utilizing the Dornier Aries 2 device.~   "
1400|NCT03038893|"~     This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep~     venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with~     suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of~     Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was~     submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.~   "
1445|NCT03038295|"~     The purpose of this study is to evaluate the safety and efficacy of oral/local propranolol~     in preterm newborns who diagnosed as early phase of retinopathy of prematurity (ROP).~   "
1376|NCT03039205|"~     About 35% of patients hospitalized with Acute Coronary Syndromes (ACS) have some degree of~     renal dysfunction. Chronic kidney disease (CKD) is not only associated to worse prognosis in~     ACS patients, but leads also to an increased risk of bleeding, which may importantly~     influence the risk-benefit ratio of antiplatelet therapy in this population. The responsible~     mechanisms for increased rate of ischemic events in this population are not completely~     elucidated.~      Antiplatelet therapy is of paramount importance in the treatment of ACS, but its benefit in~     CKD patients is not well established. This population is often excluded or underrepresented~     in large clinical trials, and the indication of antiplatelet therapy is often extrapolated~     from studies in patients with preserved renal function. In recent meta-analysis, Palmer et~     al. sought to evaluate the benefits and risks of antiplatelet agents in patients with CKD~     and concluded that in patients with ACS or scheduled for angioplasty already taking aspirin,~     the addition of clopidogrel or glycoprotein IIb / IIIa inhibitors have little or no impact~     in reducing the incidence of myocardial infarction, death or need for revascularization.~      In the PLATO trial, ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster~     onset of action and greater platelet inhibition) was compared to clopidogrel in patients~     with high risk ACS and was associated to a 16% risk reduction on the occurrence of death~     from vascular causes, myocardial infarction, or stroke. In a pre-specified sub-analysis,~     data from patients with CKD were compared to those obtained from the population with normal~     renal function and suggests that the benefit of ticagrelor may be even greater in patients~     with CKD. Two hypotheses were considered to explain these results:~        1. Greater and more consistent platelet inhibition achieved with ticagrelor would be more~          effective in reducing ischemic events in this population at increased thrombotic risk;~        2. Pleiotropic effects of ticagrelor besides inhibition of the P2Y12 receptor. Ticagrelor~          might be associated with an elevation in serum levels of adenosine. This could improve~          myocardial perfusion through coronary vasodilation, and this effect would be more~          pronounced in patients with renal dysfunction.~      This project aims to validate (or not) these hypotheses, analyzing platelet aggregation and~     circulating adenosine levels in patients taking dual antiplatelet therapy with aspirin and~     clopidogrel or ticagrelor.~   "
1377|NCT03039192|"~     The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram~     (mg) compared with intranasal placebo in addition to comprehensive standard of care in~     reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in~     participants who are assessed to be at imminent risk for suicide, as measured by the change~     from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24~     hours post first dose.~   "
1378|NCT03039179|"~     The post-operative treatment of pediatric patients operated for the correction of flat foot,~     sees today the use of preformed leg-foot splint (Walker) as an alternative to the~     application of plaster casts. The change of the immobilization system has led to the~     appearance of problems of tolerability in particular in the skin. The aim of the study is to~     assess whether by placing a polyurethane foam dress at the heel in the immediate~     postoperative period until removal of the Walker, the rate of skin lesion and pain is~     reduced.~   "
1379|NCT03039166|"~     the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD)~     as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact~     on functional dysfunction not directly related to each disease, but that could induce common~     syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.~      The objective here is to test this hypothesis and provides better understandings on~     pathophysiological processes affecting those highly connected regions in 'diffuse' and~     'focal' neurological diseases.~      The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS,~     cognitive rehabilitation ...).~      Practically, the investigators will explore 200 patients classified in 5 cohorts of 40~     patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to~     assess structural and functional brain connectivity implemented on the human 7T MR scanner~     equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).~      In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium)~     mapping will complement the MR protocol to characterize the pathophysiological processes of~     hub injury. Sixty healthy controls will also be explored wih the same protocol for normal~     database.~      The proposal aims at characterizing and comparing from a morphological-functional point of~     view, the hub regions of patients suffering from these five diseases, to demonstrate the~     pertinence to preserve hub integrity as a major therapeutic target whatever the disease.~   "
1380|NCT03039153|"~     From the point of view of nursing to know exactly the different risk factors for the onset~     of pressure ulcers is very important as it allows to accurately orient preventive care~     interventions.~      All the variable that could influence the development of pressure ulcer in patients~     undergoing knee replacement surgery are identified and collected: age, sex, body max index,~     risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers~     (typology of the devices used, such as air mattresses with alternating or static pressure,~     heel drains, frequency of mobilization carried out by both the patient care), management of~     eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of~     analgesia, length of stay, the ASA physical status classification system (ASA score),~     comorbidity, cancer, use of devices for controlling the position of the operated limb (foam~     valve), the number of physical therapy sessions actually carried out.~   "
1381|NCT03039140|"~     This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory~     fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause~     of death of women in both the general population and the breast cancer survivor population.~     There are many risk factors common to both heart disease and breast cancer development,~     including physical inactivity. A cardiac rehabilitation program may help improve~     cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality~     of life among breast cancer survivors.~   "
1382|NCT03039127|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has~     previously been characterized in breast cancer patients after receiving imILT treatment ,~     and presumed abscopal effects induced by imILT have also been described in a malignant~     melanoma patient.~      The purpose of this trial is to investigate the functionality and safety of the imILT~     treatment method in patients diagnosed with breast cancer.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic~     T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor~     border. Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Five breast cancer patients~     will be treated in this trial, which is estimated to be carried out during a time period of~     9 months.~   "
1389|NCT03039036|"~     Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However,~     the timing is highly variable. The purpose of this study is to determine if first time~     mothers undergoing induction of labor with a Foley catheter experience a decrease in their~     labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley~     catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least~     4 hours after Foley catheter removal). Other aims include the relationship between timing of~     amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal~     Apgar score <7 at 5 minutes, neonatal need for intensive care.~      The investigators hypothesize that induction of labor with Foley catheters followed by early~     amniotomy will result in a decreased duration of labor compared to those who undergo delayed~     amniotomy.~   "
1390|NCT03039023|"~     The investigators are interested in learning more about choline, a nutrient required by the~     body. The body does make some choline, but it does not make enough to support health and the~     rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary~     source of choline. Choline can also be given as a dietary supplement. Ingestion of choline~     supplements has been linked to an increased concentration of a compound called TMAO~     (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease~     risk. With this study, the investigators hope to learn whether there is a difference in the~     way your body responds to the ingestion of a choline supplement versus the choline found~     within eggs.~   "
1391|NCT03039010|"~     Swedish Quality Registry for dental health care (SKaPa) is a national registry that has~     since year 2008 gathered dental data. The data is automatically extracted from the patients'~     electronical dental data records. A vast majority of the public dental health care clinics~     deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop~     the quality of care and patient outcomes for both prevention and reparative/restorative~     methods concerning caries and periodontal disease. For children and adolescents, it is above~     all information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has~     published seven annual reports. In the report for year 2013 a limited information about the~     status of children was given, due to uncertainty in the quality of the information that is~     passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the~     data supplied to SKaPa.~      Tooth decay is the most common disease in children and adolescents that often lead to~     invasive interventions and pain. There are reports of great social disparities in dental~     health in children and adolescents in Sweden (The National Board of Health and Welfare,~     Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important~     to be able to monitor the occurrence of the disease and also examine how it differs across~     various groups of children and adolescents. This is now possible through the several~     registries that are available in the dental and health care. Register-based research will be~     an important tool to ensure that children and adolescents receive oral health and dental~     care on the same premise as others, provided the data in the registries are valid.~     Furthermore, register-based research is important for development and quality assurance of~     dental care.~   "
1392|NCT03038997|"~     To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in~     children who received anthracycline based chemotherapy (ABC).~   "
1393|NCT03038984|"~     This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.~     The purpose of this study is to determine if the IBD patients doing home monitoring~     (screening themselves on demand (OD) or every 3 months) have relative reduced rates of~     colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD~     patients are self-monitoring by web apps consisting of a short disease activity~     questionnaire (DA) and fecal calprotectin (FC) on any smart phone.~   "
1394|NCT03038971|"~     A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic~     injections of 2 different dose levels of the investigational short and tall ragweed product.~     Biomarkers will be assessed at baseline and at multiple time points post-treatment.~   "
1395|NCT03038958|"~     This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric~     prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side~     effects~   "
1396|NCT03038945|"~     Total laparoscopic hysterectomy is a procedure that is performed each time more often. One~     of the problems described for this procedure has to do with the closure of the vaginal~     vault, increased surgical time when suture laparoscopically, complications such as~     dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be~     conducted to compare two different techniques for closure of the vaginal vault.~   "
1397|NCT03038932|"~     Atopic dermatitis, also called eczema, is a disease with dry, scaly, itchy skin. Those with~     atopic dermatitis may have complications from skin infections such as eczema herpeticum~     after herpes simplex virus (HSV) infection. Symptoms of eczema herpeticum include fever and~     clusters of itchy blisters which crust over and form sores. Although exposure to HSV is~     widespread, most people clear the virus and only a subset of individuals with atopic~     dermatitis develop eczema herpeticum.~      The purpose of this study is to determine why some individuals with atopic dermatitis are at~     higher risk for recurrent skin infections with HSV. The study team will compare how people~     with atopic dermatitis with a history of recurrent eczema herpeticum, people with atopic~     dermatitis without a history of eczema herpeticum, and people without atopic dermatitis~     respond to HSV.~   "
1398|NCT03038919|"~     The researchers intend to investigate possible anabolic effects of bi-weekly exogenous~     testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control~     group will receive standard ICU management and will also be followed during ICU stay.~   "
1399|NCT03038906|"~     The proposed work will determine the effect of neuromuscular blockade on physical function~     and recovery in patients with ARDS. The investigators will conduct a prospective ancillary~     study at five PETAL clinical centers that will evaluate the neuromuscular structure and~     function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and~     after critical illness, including in-person assessments at 6 months after hospital~     discharge. The investigators hypothesize that patients randomized to NMB will have an~     increase in ICU-acquired neuromuscular dysfunction during and after critical illness.~   "
1804|NCT03033563|"~     The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or~     severe oligozoospermia after use of ejaculated versus extracted testicular sperms in~     different cycles for the same patient.~   "
1402|NCT03038867|"~     The investigators are conducting a placebo-controlled, randomized control trial with~     duloxetine in healthy, fertile men not previously on any antidepressants. Participants will~     be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will~     assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes~     measured will include semen parameters (sperm concentration, motility, morphology), hormone~     levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)~     surveys.~   "
1403|NCT03038854|"~     The purpose of this study is to determine the nutritional and cognitive effects of consuming~     Growing Up Milks (GUMs) and cow's milk.~   "
1404|NCT03038841|"~     To test the potential and acceptance of wireless activity tracking in palliative care~     patients leaving hospital care. Explorative study, collaboration project of the Clinic of~     Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss~     Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in~     order to gather objective physical activity parameters as step count, sleep duration, heart~     rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and~     distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations~     between patients' physical activity patterns and the pain and distress level assessed from~     electronic scales as well as QoL-questionnaire will be performed. Acceptance will be~     evaluated by quantitative questionnaires and interviews. The proposed study is meant to be~     preparatory work for an intervention study to test the effect of wireless monitoring of~     palliative care patients on fostering early interventions for symptom relief and support of~     QoL.~   "
1405|NCT03038828|"~     Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts.~     Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2~     weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are~     noted in cohort A patients, ten participants will be treated in cohort B. Cohort B~     participants will be treated the same as cohort A participants except that dose will be~     increased to 400IU Multikine per day.~   "
1406|NCT03038815|"~     After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects~     ankle support limit the range of motion in the joint, help pain relief, control loading of~     the injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied~     in orthopedics, sport science and rehabilitation. Numerous measure systems and methods~     enable accurate analysis of human movement.~      The study is set to describe and compare the gait analysis of two modifiable stability boots~     (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions~     (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.~   "
1407|NCT03038802|"~     This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B~     virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV~     infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has~     confirmed this vaccine to be more effective at inducing seroconversion as measured by~     development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the~     standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be~     able to induce HBV viral control and/or seroconversion in chronically infected subjects~   "
1408|NCT03038789|"~     This is a local, prospective, non-interventional, regulatory postmarketing surveillance~     study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as~     indicated by the Ministry of Food and Drug Safety (MFDS) will be included.~   "
1409|NCT03038776|"~     Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human~     clinical trials. This study will test approaches to improve the immunogenicity of H7~     vaccine, namely use of a three dose regimen, use of a modified H7 HA sequence from which the~     Tregitope has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the~     vaccine~   "
1410|NCT03038763|"~     We aim to determine the prevalence of hepatitis C in the adult children of female baby~     boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was~     either not available or was not standard of care. Because of this, their children may be~     unaware of their risk of hepatitis C.~   "
1411|NCT03038750|"~     The risk of cardiovascular disease is determined by the complex interplay between an~     individual's genetic make-up, lifestyle, and the environment. We are investigating three~     potential genetic risk factors in this observational, cross-sectional, epidemiology pilot~     study to investigate if and how functional variants identified in large-scale genome wide~     association studies can explain a predisposition to cardiovascular disease. By determining~     the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we~     hope to translate findings from this study into the clinical setting for better diagnosis,~     prevention and treatment for patients suffering with cardiovascular disease. Volunteers will~     enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1),~     PNPLA3 locus (Arm 2), or PROCR locus (Arm 3).~      Members of the Cambridge Bioresource who match for the target alleles will be invited to~     participate and will enter into one of the three study arms. All study assessment visits~     will take place at Addenbrooke's Hospital in collaboration with the University of Cambridge.~      Volunteers will participate in the study for a maximum of 12 months and depending on study~     arm they are assigned to, they will complete procedures including a medical, demographic and~     lifestyle factors questionnaire; height, weight and body fat assessments; in addition to~     blood pressure/heart rate measurements. Minimally invasive procedures including forearm~     blood flow and venepuncture will be performed to assess the primary objectives of the study.~      The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene~     locus alters the function of the endothelin receptor A leading to an increased risk of~     coronary artery disease and large artery stroke.~      For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will~     increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart~     Disease.~      For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR~     locus triggers molecular events that potentially increase the risk of Venous~     Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to~     investigate the anti-inflammatory effects to see if there is an effect on explaining reduced~     risk of CHD.~      This study has backing from the BHF Cambridge Center of Excellence and the Wellcome Trust~     Institutional Strategic Support Fund.~   "
1412|NCT03038737|"~     The aim of the present study is to evaluate the biting force of upper removable partial~     denture constructed from two different flexible thermoplastic materials.~   "
1413|NCT03038724|"~     A randomised, single-blind study (the study investigator will not know which arm each~     patient is assigned to) conducted to examine the most effective strategy for conducting HIV~     testing in the Emergency Department (ED) using an electronic tablet. The study will take~     place in the ED at Lausanne University Hospital (LUH) between August and December 2015 in~     the context of the Masters project of a medical student studying at the Faculty of Medicine~     at Lausanne University.~   "
1414|NCT03038711|"~     The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and~     well tolerated in healthy patients.~   "
1415|NCT03038698|"~     Pulmonary function testing is the most widely used tool for the diagnosis, severity~     assessment, management, risk factor categorization and follow-up of individuals with chronic~     lung disease. Africa has a high burden of infectious respiratory diseases which include~     tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with~     this is an increasing burden of non-communicable respiratory diseases; which include chronic~     obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of~     lung function testing is the determination of normal values; which are determined for age,~     gender, height and ethnicity for the relevant population. It is well recognised that the~     comparison of an individual patients' results to an ethnically inappropriate population may~     lead to the under or -over diagnosis of disease, inappropriate treatments and result in~     increased burden on individuals, their families and the healthcare system.~      We therefore propose to conduct a prospective well-designed study to include a~     representative sample of both adults and children (4000); to verify the validity of the~     retrospective pilot data, in a South African population.~   "
1416|NCT03038685|"~     The Belgian Stroke Council initiated a project to improve risk factor control and medication~     adherence in ischemic stroke patients by developing an individualized in-hospital initiated~     and post- discharge, digital coaching program addition to standard practice~     (strokecoach.be).~   "
1417|NCT03038672|"~     This randomized phase II trial studies how well nivolumab with or without varlilumab works~     in treating patients with aggressive B-cell lymphomas that have come back or do not respond~     to treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by~     stimulating the immune system to attack cancer tumor cells.~   "
1418|NCT03038659|"~     Erectile dysfunction.~   "
1419|NCT03038646|"~     -  To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of~          modified release (MR) formulations of MIN-l0l in healthy male and female subjects~        -  To select 1 MR formulation for use in fed state~        -  To evaluate the effect of food on the bioavailability of MIN-l0l selected MR~          formulation~   "
1420|NCT03038633|"~     This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel~     medical food utilizing a nutritional strain of yeast for management of Iron Deficiency~     Anemia.~   "
1421|NCT03038620|"~     This study is a clinical study to investigate the efficacy of liraglutide compared to~     placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at~     high risk for cardiovascular disease after 40 weeks on-treatment.~   "
1422|NCT03038607|"~     Intrauterine growth restriction refers to a fetus that has failed to get a specific measures~     by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal~     sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,~     because these fetuses may have fetal or neonatal complications.~      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The~     role of low-dose aspirin therapy in management of intrauterine growth restriction is~     controversial. It has been used, in many studies, in prevention of intrauterine growth~     restriction especially in women at high risk of pre-eclampsia or obstetrical~     antiphospholipid syndrome.~   "
1423|NCT03038594|"~     The investigators have previously demonstrated that thermal injury causes severe muscle~     wasting, weight and height retardation, and systemic protein catabolism in pediatric and~     adult burned patients. The persistent loss of muscle impairs the quality of life of the~     burned patients, and it also delays autonomy and reintegration into the community. In 2009,~     the investigators showed that the daily injection of recombinant human growth hormone (GH)~     for nine months post discharge significantly increased height and weight, as well as lean~     body mass, in pediatric burned subjects. Our long-term goal is to improve the quality of~     life of burn patients by preventing height, weight, and muscle loss that may occur from~     severe protein catabolism. The objectives of this application are to a) attenuate height and~     weight in burned patients with the administration of GH, b) prevent or reverse loss of~     muscle and strength in these patients, and c) collect pilot data about cardiopulmonary~     parameters, scar assessments, and muscle metabolism. Our central hypothesis is that the~     administration of GH will restore depleted levels of growth hormone and will lead to~     prevention of lean body mass loss and bone mineral content, improve rehabilitation, and~     accelerate reintegration of severely burned patients. The investigators will administer~     either placebo or GH (daily subcutaneous injections of 0.05 mg/kg/day of GH [somatropin,~     Genotropin, Pfizer, New York, NY] to adult burn subjects (n=31 per group, 18-85 years, >30%~     total body surface burns) for nine months beginning one week prior to discharge. Both groups~     will be studied for a total of two years. The following aims will be tested: 1) determine~     the effects of GH supplementation on body composition, such as lean body mass loss, muscle~     strength, and exercise endurance; and 2) assess whether rehabilitation and subsequent~     reintegration of severely burned patients into society can be accelerated. Investigators~     will measure changes in lean body mass, muscle strength and exercise endurance during the~     acute hospital stay, discharge, and long-term follow-up visits (6, 12, 18, and 24 months~     after discharge), as well as secondary endpoints such as cardiopulmonary variables (resting~     energy expenditure, resting heart rate, cardiac output, stroke volume, and liver size),~     hypertrophic scar development, muscle protein synthesis and breakdown rates, and~     concentrations of relevant hormones, cytokines, and oxidative stress markers. The proposed~     research is innovative because the administration of growth hormone in adult burned patients~     has not been explored.~   "
1424|NCT03038581|"~     Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills.~     There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries~     and compare them to traumatic wrist injuries.~   "
1425|NCT03038568|"~     The purpose of the study is to see how measurements of tumor differences vary with slight~     changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal~     tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even~     in the setting of variable scan parameters and variable contrast timing. Participants will~     be consented to undergo an additional CT of their abdomen.~   "
1426|NCT03038555|"~     Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy~     (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and~     proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal~     anomaly and systemic multi-system organs damage. Several complications, such as eclamptic~     seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic~     failure, kidney failure, placental abruption and disseminated intravascular coagulation~     (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of~     the core issues that cause the maternal and perinatal death. Morbidity of PE is~     approximately 3% to 5%. Morbidity has significant differences between different populations.~     According to the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was~     5.78%, and in the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22%~     and 27.78% respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to~     5.57% (1989 to 1998).~      In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new~     classification of HDCP based on the characteristic of disease symptoms, divide into five~     groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated~     with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far.~     The frequent sight is that PE caused by multiple reactions by a number of factors affect.~     Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular~     spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney,~     liver and brain. The research theory includes abnormal trophoblast invasion, immune response~     abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia,~     abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase~     of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However,~     there are numbers of epidemiologic study have analyzed high risk factor of PE which provides~     significant medical evidence of prevention, early diagnosis and early treatment for PE,~     there is only little study focus on susceptibility gene and pathogenic genetic variation.~     Nowadays, there are numerous clinical phenotype are considered to exist, different phenotype~     gives different inheritance and epigenetics. Thus, our group will examine the onset of type~     and characteristics of PE by a retrospective cohort study to discuss if susceptibility gene~     and pathogenic genetic variation were existing in PE patients, also to find the relativity~     between clinical phenotype and genotype. Moreover, this study is trying to reach the effect~     of PE on the patients' health as well as their children. Thus, can predict the health status~     of PE patients and their children, and so can prevent (avoid or delay) of the patients from~     late complications and disease in their children.~   "
1427|NCT03038542|"~     This study evaluates a text messaging intervention through a smokers' quitline. Smokers will~     either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored,~     standard care text messages, both combined with standard quitline treatment. We hypothesize~     that the gain-framed text message intervention will increase cessation rates at 30 weeks as~     compared to standard care text messages.~   "
1428|NCT03038529|"~     Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset~     amelioration of symptoms, with a sustained duration pain relief in low back pain.~      Does change of injection approach make a difference?~   "
1429|NCT03038516|"~     To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer~     patients can decrease opioid consumption, fatigue and infectious burden and increase quality~     of life.~   "
1446|NCT03038282|"~     The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial.~     The hypothesis of the study is to evaluate the effect of supplementing the AD individuals~     with Chromium combined with exercise and assessing the effect of the supplementation on~     glucose metabolism.~   "
1430|NCT03038503|"~     The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6~     hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid~     resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate~     with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock~     with catecholamine resistance has been studied such as terlipressin, methylene blue~        -  Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C,~          and increases intracellular Ca2+ concentration~        -  Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme~          guanylate cyclase (GC)~   "
1431|NCT03038490|"~     To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine~     and HMB for a maximum period of four weeks is more beneficial than the standard dietary~     approach to the healing of pressure ulcers, and to examine whether the use of it can reduce~     admissions and length of hospitalizations for these patients.~   "
1432|NCT03038477|"~     This is a two-arm, open-label, phase II study of in adult patients who have successfully~     undergone R0/R1 resection of PDAs following neoadjuvant chemotherapy and completion of~     adjuvant chemotherapy. Within 1-3 months of treatment completion, patients will be enrolled~     and randomized at a 1:1 ratio to receive durvalumab versus observation.~   "
1433|NCT03038464|"~     The two-stage protocol is gold standard in terms of infection control treating prosthetic~     joint infections of total hip and total knee arthroplasty. The antibiotic pause for~     diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of~     infection and development of resistant bacterial strains. Serological markers and synovial~     analysis are common use to exclude persistence of infection.~      The investigators therefore asked 1) is the serological testing of c-reactive protein and~     leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of~     synovial aspiration of PMMA Spacers on hip and knee joints.~   "
1434|NCT03038451|"~     s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any~     hypertension treatment before or have received any of anti-hypertensive mono-therapy for the~     first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be~     administered for the last four weeks (4-8 weeks).~   "
1435|NCT03038425|"~     This is a randomized, double-blinded pilot study to determine whether patients undergoing~     ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the~     addition of a continuous adductor canal nerve block (cACB) catheter along with an existing~     multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of~     Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days,~     functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction,~     patient's rating of catheter effectiveness, and complications.~   "
1436|NCT03038412|"~     The purpose of this study was to evaluate the applicability of auto-fluorescence imaging~     system to detect and quantify caries and dental plaque. Participants were advised to rinse~     their mouth with distilled water to exclude any chance of fluorescence from food debris. A~     well trained physicist majored in optical spectroscopy captured auto-fluorescence images of~     buccal aspects of two maxillary central incisors and occlusal aspects of four first molars~     from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley~     Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also~     required to brush their teeth for 3min, then International Caries Detection and Assessment~     System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an~     experienced dentist using a mouth mirror and explorer. The Spearman rank correlation~     coefficient between colorimetric parameters of fluorescence image and the plaque index and~     ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence~     imaging system.~   "
1437|NCT03038399|"~     This long-term extension study is an open-label, multiple‑dose study to evaluate the~     long‑term safety, tolerability, efficacy and PD of vamorolone administered once daily by~     liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who~     participated in the VBP15‑002 Phase IIa and VBP15-003 Phase IIa extension core studies.~   "
1438|NCT03038386|"~     Rationale: Gout is a disease with growing incidence and complexity due to increased life~     expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy,~     demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi~     (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis~     is difficult to ascertain due to sampling error (no synovial fluid acquired because the~     needle was not exactly placed in the affected joint, or the location of the gout might have~     been extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g.~     infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This~     technique allows the visualization and quantification of MSU. Although imaging modalities~     such as DECT show promise in the classification of gout, the studies to date have been small~     and have primarily involved people with established disease.~      A study with cross-sectional design in which patients for whom the clinical questions does~     this patient have gout? are referred for participation may contribute to assess the value~     of DECT scan in diagnosing acute arthritis caused by gout.~      Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.~      Study design: Prospective Study population: Patients with acute mono or oligo arthritis~     without prior diagnosis, the rheumatologist has an indication for diagnostic needle~     aspiration.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without~     prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by~     blind aspiration or ultra sound guided aspiration depending on the judgement of the~     rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to~     detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been~     established and is therefore not used in daily practice. In this study all patients undergo~     DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If~     the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained~     prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound~     guided aspiration will take place, with knowledge of DECT results, followed by repeat~     microscopy~   "
1439|NCT03038373|"~     The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes~     in the morbid obese patients after laparoscopic sleeve gastrectomy.~   "
1440|NCT03038360|"~     CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a~     novel predictive model and a diagnostic tool, for the risk stratification of AMI patients~     undergoing PCI, with a one year follow-up.~   "
1441|NCT03038347|"~     The purpose of this study is to determine whether a web-based training program with~     text-based information as well as practical exercises can improve cross-cultural~     competencies in therapists.~   "
1442|NCT03038334|"~     This study is to examine the possible effect of supplementing Magnesium sulfate on patients~     with Alzheimer Disease (AD) in controlling or reducing the amount of amyloid present in the~     brain, and increasing cognitive ability in individuals that have amyloid deposits.~   "
11164|NCT02911051|"~     The clinical study evaluates the safety of a new catheter for Urinary Intermittent~     Catheterisation in self catheterized patients~   "
1448|NCT03038256|"~     The purpose of this study was to evaluate the effect of 4 Cycles XELOX Pre- and post-a~     delayed TME compared with 8 Cycles XELOX post-a Regular Timing TME after Continuous Infusion~     Fluorouracil with Long-term Radiotherapy for patients with high-risk rectal cancer defined~     by MRI.~   "
1449|NCT03038243|"~     This is a research study about an experimental (investigational) oral inactivated whole cell~     Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT. Sf2aWC is a killed~     vaccine that is being made to prevent disease from Shigella., which causes bloody, watery~     diarrhea. An adjuvant is something that is added to a vaccine to make it work better. The~     purpose of the study is to see if the vaccine will protect people from Shigella infection~     with or without an adjuvant called dmLT. About 72 healthy adults, ages 18-45, will~     participate in this study. The study will compare 2 different vaccination groups and 1~     control group. Volunteers have an equal chance to be in any of the 3 groups. Study~     procedures include: stool samples, blood samples and documenting side effects. Participants~     will be involved in study related procedures for about 6 months.~   "
1450|NCT03038230|"~     This is a First-in-Human, single arm, open-label, multi-national study designed to determine~     the safety, tolerability and preliminary efficacy of MCLA 117.~   "
1451|NCT03038217|"~     In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in~     the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal~     cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical~     specimens, and observation of patients undergoing radical resection of the tumor with or~     without adjuvant chemo- and/or radiotherapy.~   "
1452|NCT03038204|"~     Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty~     for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of~     these procedures is the papillary muscles approximation. However, the safety and the~     positive impact of this method are still in doubt.~   "
1453|NCT03038191|"~     Epilepsy is a group of neurological disorders characterized by propensity for spontaneous~     epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell~     activity in the brain. About 0.7-1% of the world population suffers from seizures. The most~     common treatment is based on seizure medications that enables about 2/3 of the patients to~     control their seizures. However, about 20 million patients worldwide, suffer from~     unpredictable seizures without remedy, and are resistant to medication.~      In this study EEG and other physiologic signals are collected using wearable sensors, from~     Epilepsy patients who are at risk of experiencing seizures. The collected signals will be~     used for developing algorithms that may identify pre-seizure and seizure related periods.~   "
1454|NCT03038178|"~     The proposed study will assess the efficacy, safety and tolerability of once daily dosing of~     Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC)~     mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines, for~     treatment of mycobacterium abscessus lung disease.~   "
1455|NCT03038165|"~     While the exact pathogenesis of Intradialytic hypertension remains to be determined, several~     mechanisms were proposed to be involved. The main factors to determine the arterial blood~     pressure are the peripheral vascular resistance and cardiac output. The assumption is that~     the increase of blood pressure is related to the increase in peripheral vascular resistance~     during the dialysis session, due to fluid removal and fast reduction of the intravascular~     volume reduction.~      Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients~     with intradialytic hypertension will be evaluated~   "
1456|NCT03038152|"~     The goal of this clinical research study is to learn more about the safety and effectiveness~     of a marker called Magseed that is used to help participant's doctor locate lymph nodes that~     contain cancer under participant's arm during surgery. The Magseed marker is a small~     metallic marker (smaller than a grain of rice) which is placed in or near the lymph node by~     participant's radiologist.~   "
1457|NCT03038139|"~     The purpose of this study is to investigate the changes of spinal muscle activation in~     cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after~     application of two correction programs; a conventional one including cervical and thoracic~     spine, and a second program involving lumbosacral segment.~   "
1458|NCT03038126|"~     Home telehealth monitoring of veterans with chronic kidney disease, with a disease~     management protocol and safety-specific decision support, will increase the detection of~     adverse safety events, and in turn, reduce the need for urgent health resource utilization~     and associated poor outcomes.~   "
1459|NCT03038113|"~     This randomized study will be conducted in two parts to evaluate the safety, tolerability,~     pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1~     will include only healthy participants and Part 2 will include only participants with~     chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an~     adaptive dose-escalating schedule to determine the best dose to be evaluated in participants~     with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts~     which will be used to further refine the dose and dosing regimen.~   "
1460|NCT03038100|"~     This is a Phase III, global, double-blind, two-arm, randomized study designed to evaluate~     the efficacy and safety of atezolizumab administered with paclitaxel + carboplatin +~     bevacizumab compared with placebo + paclitaxel + carboplatin + bevacizumab in participants~     with Stage III or Stage IV ovarian (OC), fallopian tube (FTC), or primary peritoneal cancer~     (PPC) who have macroscopic residual disease postoperatively (i.e., after primary tumor~     reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.~   "
1461|NCT03038087|"~     The purpose of this research study is to find out whether a device for monitoring bleeding~     in patients with acute hemorrhagic stroke will show similar findings as CT scans performed~     to evaluate the stroke.~   "
1462|NCT03038074|"~     The objective of this clinical investigation is to collect high-resolution pulse oximetry,~     RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to~     build a database of representative pulse oximetry and respiratory signal profiles for~     patients in this population.~   "
1555|NCT03036852|"~     The primary objectives of this study are to evaluate safety, efficacy and tolerability of~     treatment with sofosbuvir (Sovaldi®)/velpatasvir (SOF/VEL) for 12 weeks in adults with~     chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease~     (ESRD).~   "
1463|NCT03038061|"~     Position of diaphragm in the region of electrical impedance tomography measurement is to be~     determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to~     be obtained at three phases at supine horizontal position (during spontaneous breathing, at~     mechanically ventilated patient under general anesthesia with muscle relaxation and at~     mechanically ventilated patient under general anesthesia with muscle relaxation during~     capnoperitoneum).~   "
1464|NCT03038048|"~     We are comparing the patient experience between the standard 30 g needle to the smaller 33 g~     needle for intravitreal injections of ranabizumab or aflibercept for age related macular~     degeneration, diabetic macular edema, or retina vein occlusions.~   "
1465|NCT03038035|"~     MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and~     neuroproliferative properties in cellular and animal models of brain injury. It contains 9~     herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601,~     containing only the 9 herbal components yet showing the same efficacy has become available.~      This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together~     with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901)~     helps in slowing down the Alzheimer's disease progression.~      This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by~     an open extension study in which all subjects who completed the main 6 month trial~     (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6~     months.~   "
1466|NCT03038022|"~     The primary objective of this study is to determine the effect of once-daily oral MGL-3196~     on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in~     patients with Heterozygous Familial Hypercholesterolemia (HeFH).~   "
1467|NCT03038009|"~     The purpose of this study is to determine whether 12-month prophylactic treatment with~     pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE)~     increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper~     gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The~     potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by~     esophagogastroduodenoscopy (EGD).~   "
1468|NCT03037996|"~     Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take~     care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of~     needs; human's pleasure is classified as physiological, safety, belonging, esteem and~     self-actualization. Since defining and measuring quality of healthcare service is an~     inevitable challenge for all institutes in medical fields, a questionnaire is developed to~     assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire~     (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and~     convenience, Communication and Information, Process of care, Technical Quality,~     Psychological support, Physical support and Royalty.~   "
1469|NCT03037983|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) is effective in remediating cognitive deficits while also improving~     functionality in Veterans with schizophrenia.~   "
1470|NCT03037970|"~     ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth~     factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE~     is under development for the treatment of chronic and acute wounds. This study investigates~     the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).~   "
1471|NCT03037944|"~     This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine~     device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy~     menstrual bleeding and Dysmenorrhea caused by Adenomyosis.~   "
1472|NCT03037931|"~     The primary objective of this study is to determine the efficacy and safety of iron therapy~     using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of~     participants in heart failure with iron deficiency and with a reduced ejection fraction.~   "
1473|NCT03037918|"~     Participants will be randomly allocated to either Yakult ingestion or a control group. For~     the first 20 days, subjects will consume their normal diet (keeping a detailed food diary~     throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.~      The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will~     alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic~     inflammation as well as decreasing whole body insulin sensitivity (as we have shown~     previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days~     before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and~     prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action /~     insulin sensitivity.~   "
1474|NCT03037905|"~     Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods~     to reduce anxiety in the operating room itself. STERIS Corporation has developed an~     automated surgical suite environmental system, called SignatureSuite™, that controls the~     level of lighting, images on OR monitors, and ambient background audio via preset,~     computerized automation for use before and after anesthesia. This study aims to determine if~     this new type of operating room environment decreases anxiety, as measured by patient~     reports, vital signs, and postoperative analgesic use. The proposed study will be a mixed~     method, two-arm, randomized controlled trial comparing anxiety levels for patients that have~     thyroid or parathyroid surgery in the SignatureSuite room at Cleveland Clinic Marymount~     Hospital versus the standard operating room environment. Randomization will occur at the~     surgeon level. There will be a maximum 100 patients divided equally between the experimental~     and control arms of the study. Staff perceptions of the room will also be assessed at the~     conclusion of the study.~   "
1556|NCT03036839|"~     The primary objectives of this study are to evaluate the safety, efficacy and tolerability~     of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus~     (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).~   "
1557|NCT03036826|"~     Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost~     renal function and continuous renal replacement therapy is nearly impossible without~     measuring the drug concentration in blood samples. In many hospitals that is not an option.~     The investigators aim to show, that computer based calculation can avoid over- or~     under-dosing.~   "
1558|NCT03036813|"~     A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440~     Administered Orally to Patients With Sickle Cell Disease~   "
1475|NCT03037892|"~     Colonoscopy is one of the most commonly performed outpatient procedure for diagnosis and~     treatment of lower gastrointestinal tract disorders. It has been largely accepted as an~     effective tool for colorectal cancer(CRC) screening, given its ability to detect and remove~     identified polyps. Increased colonoscopy utilization is associated with the observed decline~     in the incidence of CRC and its diagnosis at earlier stages. Diagnostic and therapeutic~     colonoscopy can successfully be performed using moderate sedation in the ambulatory setting.~     Techniques of sedation must guarantee the comfort and safety of patients, and at the same~     time allow a rapid turnover of patients.. An anaesthetic agent with rapid onset and offset~     of action, and convenient titration of anaesthetic/analgesic depth as well as rapid recovery~     to enable discharge from the endoscopy unit as soon as possible would be ideal as most such~     procedures are performed in the Non-Operating Room Anaesthesia(NORA) settings.~      There is recent interest in the use of Remifentanil, in endoscopic units as it might have~     advantages over other drugs because of its profound analgesic effects, rapid onset and~     offset time and rapid titration to the individual patient's requirements and intermittent~     pain during colonoscopy.~      The aim of this randomized study is to test the hypothesis that a colonoscopy of good~     quality in terms of pain relief, patient comfort and discharge times with less~     cardiorespiratory side effects can be performed using Remifentanil as a sole agent as~     compared with the standard midazolam/fentanyl protocol. The second group combining~     Remifentanil with Midazolam is taken to evaluate if there is any advantage of adding an~     anxiolytic amnesic drug as used in the standard Midazolam/Fentanyl Protocol.~   "
1476|NCT03037879|"~     Multiple studies in the spinal cord injury (SCI) population have documented deficits in~     learning and memory (LM) and processing speed (PS) that adversely impact daily life and the~     ability to benefit from rehabilitation. The investigators have previously attributed the~     cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and~     cerebral blood flow (CBF) and are currently conducting a study to determine the effect of a~     30-day elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and~     cognitive performance compared to placebo in hypotensive individuals with SCI. In addition,~     the investigators believe that cognitive behavior therapy (CBT) may improve cognition~     independent of changes in BP and CBF in individuals with SCI. The current randomized~     clinical trial (RCT) will examine the efficacy of 2 treatment protocols shown to be~     effective in improving cognitive performance in other neurologically impaired populations~     for use in persons with SCI demonstrating (1) LM impairment and/or (2) PS impairment on~     objective measures of cognitive functioning during a complete Neuropsychological assessment.~     Two methods of outcome assessment will be used to examine treatment impact: (1) a~     traditional Neuropsychological assessment (NP) and (2) an assessment of global functioning~     (AGF) composed of broader outcome measures that examine the impact of the treatment on~     everyday life activities. In this way, the investigators will be able to objectively~     evaluate the presence or absence of changes in memory performance through a NP assessment,~     while also evaluating the impact of this treatment protocol on everyday life through the~     AGF. While most studies evaluating the efficacy of cognitive retraining usually employ a~     pre- and post-training evaluation, such evaluations have been criticized for their lack of~     ecological validity (i.e., real world generalizability). The present design allows the~     assessment of the efficacy of these treatment techniques within an SCI population using~     traditional measures, as well as the assessment of the impact that treatment has on everyday~     life. The investigators will additionally evaluate the long-term efficacy by including a~     6-month post-treatment follow-up. Few studies examine long-term effects, but given the time,~     labor and expense involved, it is critical to demonstrate long-term efficacy.~   "
1477|NCT03037866|"~     This project is designed to address the urgent need for an effective primary prevention~     approach to the problem of sexual violence among college students. The project involves~     developing, feasibility testing, and testing for effectiveness an innovative new approach to~     the primary prevention of sexual violence, alcohol, and drug abuse among college students~     utilizing both online e-learning and small group facilitator-led intervention modalities.~     The intervention is an adaptation of the successful evidence-based substance abuse and~     violence prevention approach called Life Skills Training (LST). The adapted intervention is~     designed to address the relationship between sexual violence and substance abuse; positively~     change social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to~     identify and appropriately respond to problematic situations; and build social,~     self-regulation, and relationship skills through interactive learning and behavioral~     rehearsal scenarios. At the conclusion of the study, the investigators expect to be able to~     widely disseminate and market a new evidence-based primary prevention intervention for~     sexual violence for use in a variety of higher educational settings.~   "
1478|NCT03037853|"~     The goal is the constitution of a statistical atlas of the human being morphology~     variability.~      This work would be a significant step forward in the field of anatomy and biomechanical~     simulation.~   "
1479|NCT03037840|"~     Studies have shown that tumor specific amplitude-modulated frequencies of radiofrequency~     electromagnetic fields that is associated with biofeedback upon exposure to in cancer~     patients. However, such discovery in other cancer patients are rare. And whether tumor~     specific frequencies can be found in Asian cancer patients remains unclear. The purpose of~     this study is to detect the tumor specific frequencies of Asian cancer patients in vivo.~   "
1480|NCT03037827|"~     A multicenter clinical randomized controlled trial, comparing of three different regimens of~     endovenous laser ablation with equal linear endovenous energy density in patients with~     insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED)~     is the main value for standardization EVLA. From many studies, it is known the optimum value~     of the LEED. However, the same LEED may be obtained by varying the ratio between the laser~     power and the fiber pullback speed. Power decrease can allow to reduce the incidence of~     adverse effects of endovenous laser ablation, but keep high efficiency.~   "
1481|NCT03037814|"~     The purpose of this study is to evaluate and compare the clinical performance of dental~     restorative materials in Class II cavities of primary molar teeth~   "
1482|NCT03037801|"~     Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit~     suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure~     Ventilation. The patient population will be divided into two groups, one group will receive~     conventional treatment and the other group will receive conventional treatment and three~     times a day of physiotherapy using Intrapulmonary Percussive Ventilation.~   "
1483|NCT03037788|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and~     efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.~   "
1603|NCT03036228|"~     The primary objective of this study is to determine safety and tolerability of Karonudib for~     the treatment of cancer.~      Secondary objectives are to determine a recommended RP2D and schedule for further~     development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for~     evidence of treatment efficacy. Overall survival will also be recorded.~   "
3027|NCT03017586|"~     The purpose of this study is to evaluate the safety and effectiveness of deep brain~     stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for~     primary dystonia.~   "
1484|NCT03037775|"~     It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from~     tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion~     criteria are medical history of stroke, coronary artery disease, chronic heart failure,~     hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity~     (BMI> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will~     actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18~     mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random~     allocation to groups exposed to electronic or traditional cigarette smoke in cross-over~     scheme. The primary endpoint is the maximum change in heart rate compared to mean values~     prior to exposure. Secondary end points is the maximum change in the measured parameters~     (hemodynamic and autonomic values) compared to the average values before exposure. The~     measurements will be performed using the Task Force Monitor system for non-invasive~     measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic~     activity will be tested with microneurography. A periodic analysis is planned after~     examining 15 and 35 patients.~   "
1485|NCT03037762|"~     Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological~     deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular~     diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most~     frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of~     the efficacy and safety of swallowing, determination of appropriate feeding strategies and~     assessment of the efficacy of different swallowing manoeuvres. The literature furthermore~     indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at~     evaluating findings and side effects of FEES in a heterogeneous collective of patients with~     neurogenic dysphagia.~   "
1486|NCT03037749|"~     Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per~     year with over $6 billion in direct medical and mental health costs alone. Alcohol is~     present in most incidents of IPV, and contributes to more frequent and severe IPV incidents.~     These facts, coupled with the fact that there are no effective interventions for IPV, make~     understanding mechanisms through which alcohol is associated with IPV critical.~   "
1487|NCT03037736|"~     This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil~     subconjunctival injections vs placebo for the recurrence of pterygia after excision using~     conjunctival autograft.~   "
1488|NCT03037723|"~     Radiation therapy to the breast has remained a standard practice for breast conserving~     therapy. Because of the location of the heart and lungs when patients are positioned~     face-up, whole breast radiation therapy has been reported to increase the risk of damage to~     the heart a few years after treatment until at least 20 years after exposure, and may affect~     cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an~     increased risk for development of secondary lung malignancies. Recent studies have~     demonstrated a significant reduction in dose to the heart and lungs when treated in the~     face-down position. Similarly, correcting for the movement of breathing (respiratory gating)~     in the face-up position has also become an available option for reducing unwanted dose to~     the heart and lungs, particularly in left sided breast cancers. No study to date has~     compared these newer organ-sparing techniques head-to-head for early stage breast cancer.~      It is institutional policy to perform CT simulation in left-sided breast cancer patients~     with and without the respiratory gating (this is one CT scan), in the face-up position. It~     is also standard of care to perform the face-down CT simulation in large breasted women.~     Both of these simulations are meant to reduce the exposure of the heart and lungs to~     radiation.~      In this study, all left-sided breast cancer patients that consent will receive face-up CT~     simulation with and without gating AND face-down CT simulation, regardless of breast size;~     thus, each patient is their own control.~      The treating physician will determine which of the two simulations, if any, offers better~     protection to each patients' heart and lungs. Two dosimetrists will be required to~     independently verify planned dosimetry with all treatment setups. Treatment will be planned~     in standard fashion using the best of the two plans.~   "
1489|NCT03037710|"~     This is a multi-center, non-randomized, non-interventional study to evaluate the accuracy of~     a remote monitoring and analytical platform for prediction of heart failure exacerbation.~     The platform acquires continuous multivariate vital signs from HF patients using a new~     ambulatory wearable (attached by an adhesive) multi-sensor device and analyzes the data~     using a novel machine learning algorithm.~   "
1490|NCT03037697|"~     The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and~     strapping system on increasing axial stability that will reflect on improving balance and~     walking performance in children with dyskinetic cerebral palsy.~   "
1491|NCT03037684|"~     The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain~     phenomena in neuropathic pain and chronic postoperative pain.~   "
1492|NCT03037671|"~     This study is designed to determine feasibility of using a continuous glucose monitor in~     pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients,~     and to identify the incidence and risk factors for malglycemia in primary admission for~     pediatric, adolescent and young adult HSCT patients as well as to characterize the~     relationship between outcomes and malglycemia in this population.~   "
1493|NCT03037658|"~     In this study, the investigators will test responsiveness of young, middle-aged, and older~     adults to a range of incentives, some of which provide rewards for the individual~     participants and others that offer rewards to other people or groups. The investigators~     hypothesize that incentives are differentially effective for different age groups.~   "
1494|NCT03037645|"~     Phase 1b (Dose Escalation) in primarily CLL/SLL patients will evaluate safety and~     pharmacology of self-administered twice a day oral doses beginning at 25 mg/dose for 4 weeks~     with succeeding cohorts at escalating doses until establishing dose limiting toxicity or,~     recommended Phase 2 dose. Patient data will be assessed before authorizing dose escalation~     cohorts. Phase 2 (Cohort Expansion) will follow in cohorts using the recommended dose to~     explore clinical activity, safety, pharmacology of SNS-062 as monotherapy.~   "
1495|NCT03037632|"~     The study aim of the DCM Precision Medicine Study is to test the hypothesis that DCM has a~     substantial genetic basis and to evaluate the effectiveness of a family communication~     intervention in improving the uptake and impact of family member clinical screening.~   "
1604|NCT03036215|"~     The purpose of this pilot project is to determine the feasibility of methods and estimate~     the preliminary efficacy of a tailored self-management program to decrease pain and prevent~     chronic pain in patients with temporomandibular disorders compared with traditional~     self-care. This program is designed to educate and engage patients in an 8-week personalized~     program of exercise and behavioral changes implemented through web-based on-line program~     supported by a health coach~   "
1605|NCT03036202|"~     To determine the pharmacokinetics of epinephrine during cardiac arrest.~   "
1606|NCT03036189|"~     This is a group randomized trial of an intervention to improve chronic illness~     self-management.~   "
1496|NCT03037619|"~     Patients undergoing knee replacement typically report improved health-related quality of~     life, increased physical function, and reduced pain. Despite these improvements, physical~     activity levels remain unchanged, or only minimally increase from pre-operative levels, yet~     do not reach the same level of activity observed among healthy populations. Knee replacement~     patients often expect their activity levels and function to improve following surgery, but~     the majority of patients' activity levels 5 years post-operatively did not meet their~     pre-operative expectations. Even though improvements are observed in pain and function,~     reasons for the maintenance of low levels of activity are unknown. Technology has the~     potential to increase physical activity levels in these patients, particularly as 81% of~     knee replacement patients in our recent study had a smartphone, and 40% were willing to wear~     a wrist-worn physical activity monitor. As the average age of knee replacement continues to~     decrease, we anticipate that the percent of patients with a smartphone and willingness to~     wear an activity monitor will increase. In addition to technology, social support is~     associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn~     physical activity monitor and providing additional opportunities for social support via the~     technology may increase physical activity levels in these patients. The current pilot study~     aims to gain preliminary data on the influence of wearables and social support on physical~     activity in knee replacement patients following surgery. Specifically, we aim to recruit 20~     patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support.~     Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4~     months. Participants in the Fitbit+Support group will be asked to identify a buddy. Both~     the participant and buddy will be given a Fitbit and they will be asked to friend each~     other via Fitbit and wear the monitor for 4 months.~   "
1497|NCT03037606|"~     It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed~     release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in~     patients with Gastroesophageal Reflux Disease (GERD).~   "
1498|NCT03037593|"~     Demonstrate dose-dependent relationship between vitamin D supplementation and rates of~     gestational diabetes.~   "
1499|NCT03037580|"~     This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,~     placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary~     hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).~     Once randomized, subjects will take the initial dose of study drug at the study site on the~     day of randomization. Subjects will return to the study site for visits scheduled at Weeks~     6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.~   "
1500|NCT03037567|"~     The purpose of this study is to examine the acceptability and efficacy of a modified Weight~     Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.~   "
1501|NCT03037554|"~     A home-based, sham-controlled, double-blind, crossover study evaluating the effects of~     wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep~     measures, proximal skin temperature, and sternal skin moisture in menopausal women~     complaining of sleep disturbance and vasomotor symptoms.~   "
1502|NCT03037541|"~     Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as~     tolerated, though local irritation often occurs within the first week of treatment and~     increases in a dose-dependent manner. In this study, the investigators will examine the~     combination of standard cryosurgery treatment followed by a shortened course of topical~     fluorouracil cram. The investigators anticipate that a one week treatment course will~     maintain overall effectiveness when combined with previous cryosurgery, but will reduce the~     overall adverse effects of topical therapy due to the reduced treatment time and the~     presence of fewer baseline lesions to treat. This treatment approach may provide a more~     acceptable risk/benefit ratio option for patients with more extensive disease and simplify~     standard combination treatment options. The primary objective is to evaluate the efficacy of~     combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery~     and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination~     therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter~     will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.~   "
1503|NCT03037528|"~     The goal of the research is to optimize an online and mobile multicomponent 12-month diet~     and lifestyle intervention for improving the blood glucose control of individuals with type~     2 diabetes.~   "
1504|NCT03037515|"~     The purpose of this project is to compare the effectiveness of two different but well~     accepted routes of administration of tranexamic acid in order to reduce blood loss and need~     for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks~     to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing~     blood loss and need for transfusion.~   "
1505|NCT03037502|"~     If the investigators are to adequately address the health needs of African American and~     Latino men, both culture and gender must be considered when developing and implementing~     strategies to increase their healthy eating and physical activity and decrease tobacco~     use.The aim of this project is to develop and test gendered, culturally and contextually~     relevant messages that will be used in a future, web- based tailored intervention to~     encourage tobacco cessation and increase healthy eating and physical activity in African~     American men. This study is part of a larger research agenda that for a decade has focused~     on understanding and reducing chronic disease risk among African American and Latino men.~     Because men are more likely than women to engage in over 30 behaviors known to increase~     their risk of injury, morbidity, and mortality, improving men's health requires~     understanding the social and cultural factors that help explain sex differences in health.~     Operationalizing gender in individually-tailored health communications has great potential~     to unlock the potential of health communications and interventions to engage and improve the~     health of men and particularly African American and Latino men. To date, no community-based~     intervention has produced clinically significant improvements in weight loss, healthy eating~     or physical activity in Latino and African American men. It also is unclear how technology~     can be used to promote these behaviors in this population. Thus, there is a need to develop~     healthy eating, physical activity and weight loss interventions specifically targeted and~     tailored to African American and Latino men that explores the utility of technology. This~     intervention content and focus represents a novel strategy to promote health equity by using~     technology-based health care innovations to improve healthy eating and active living by~     addressing a root cause of unhealthy behavior in men: notions of manhood. The investigators~     focus on gender and manhood because they are under-explored factors that shape men's health~     behaviors.~   "
1506|NCT03037489|"~     This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety~     and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).~   "
1507|NCT03037476|"~     This research will adapt an evidence based intervention for alcohol and other drugs and~     evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in web-based and~     in-person formats for use with college students who have misused PSMs.~   "
1508|NCT03037463|"~     The purpose of this study is to assess whether tear secretion in patients with Parkinson's~     disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that~     will be reflected in changes in the protein composition of tear fluid, which can be measured~     relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be~     collected from Parkinson's patients, and through biochemical assays, the profile of proteins~     in tears will be characterized and compared to that from control subjects. The profiles will~     be analyzed with respect to any differences between Parkinson's patients and control~     subjects. If differences appear, the levels of these potential biomarkers in Parkinson's~     patients will be compared to the severity of their disease.~   "
1509|NCT03037450|"~     Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of~     the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several~     corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring,~     neovascularization, thinning, perforation or infection. An important and permanent visual~     loss of is frequently associated with the condition. NK can be congenital or acquired. Its~     acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or~     iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction~     techniques of sensory neurotizations have recently been described in young patients~     suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory~     donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a~     healthy donor nerve segment into a tissue to reestablish either motor or sensory~     innervation. The aim of the present study is to assess the outcomes of a novel sensory~     neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of~     Mackie classification). Corneal neurotizations will be performed using either ipsilateral~     supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve~     as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft.~     Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and~     an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve.~     Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with~     unilateral NK due to infectious, traumatic or iatrogenic causes will be included.~   "
1510|NCT03037437|"~     The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when~     compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ~     would lead to disease stability in patients with advanced hepatocellular cancer (HCC).~   "
1511|NCT03037424|"~     This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded,~     non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian~     hospitals will participate, and the trial will require up to 2 years for patient~     recruitment.~      Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen~     supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will~     be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or~     cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation~     and deems it to be in accordance with accepted clinical standards. Thereafter, patients will~     be treated according to their assigned group each time fibrinogen supplementation is ordered~     during the treatment period (24 hours after termination of CPB). No other aspects of care~     will be modified.~      The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red~     blood cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first~     24 hours after termination of CPB. Safety outcomes will be measured for the first 28 days~     after surgery, which is the duration of participation of each patient in the trial.~     Comparisons will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis.~     One interim analysis will be conducted after 600 patients have been treated to determine~     whether the study should be terminated for safety reasons, demonstrated non-inferiority or~     futility reasons.~   "
1512|NCT03037411|"~     The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up~     (PMCF) trial providing additional data including health economics data to support the use of~     the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.~   "
1513|NCT03037398|"~     The objective of this study is to evaluate the performance of novel DBS programming methods~     compared to traditional programming methods.~   "
1514|NCT03037385|"~     This is a Phase 1, open-label, first-in-human study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic~     activity of BLU-667 administered orally in patients with NSCLC, thyroid cancer and other~     solid tumors.~   "
1515|NCT03037372|"~     This study will determine whether 36 months of daily atorvastatin or rosuvastatin have~     equivalent effects in reduction of immune activation, inflammation and immune aging, when~     given as adjunct therapy among patients receiving antiretroviral therapy in an African~     cohort~   "
1516|NCT03037359|"~     This is a safety study to evaluate the risk of low blood pressure in subjects with Primary~     Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under~     real world conditions. No study medication will be provided to subjects in this study. Study~     physicians will make all treatment decisions according to their usual practice and will~     provide prescriptions for his/her subjects, as appropriate. The only addition is the~     collection and structured documentation of data generated through usual practice.~   "
1517|NCT03037346|"~     The goal of this research study is to learn how well MD Anderson helps patients and their~     families select and prepare an MPOA. Researchers want to find out if social work counseling~     and education help to increase the number of patients who complete MPOA documents. They also~     want to study how counseling and education affects attitudes about medical decision-making,~     and willingness to take part in these kinds of conversations for patients and their family~     members and/or caregivers.~   "
1518|NCT03037333|"~     A lot of questions about use of temporary transvenous pacing still remain obscure and there~     is no effective comparison between use of fluoroscopy versus~     electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to~     evaluate how long does it take to start the correct cardiac stimulation with transvenous~     pacing in patients with bradicardias comparing use of fluoroscopy versus~     electrocardiogram/echocardiogram and compare rates of complications between two methods.~   "
1519|NCT03037320|"~     Comparison of Coronally advanced flap with semilunar vestibular incision technique for root~     coverage in patients with multiple gingival recession in maxillary teeth.~   "
1520|NCT03037307|"~     The objective of this study will be to compare bite force (BF) measurements over a 12-hour~     period of a currently marketed denture adhesive cream based on carbomer technology (test),~     with a positive control and a negative/no treatment control.~   "
1640|NCT03035747|"~     Ongoing registration of patients with varicose veins disease treated by means of~     conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal~     methods~   "
1641|NCT03035734|"~     Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to~     healthy female subjects of non-childbearing potential and healthy males.~   "
1521|NCT03037294|"~     Rationale: Osteoarthritis (OA) of the knee is a common cause of pain and disability,~     especially in people over the age of 65. In the current health care system both conservative~     (e.g. intra-articular injections with corticosteroids) and surgical (total knee replacement,~     TKR) treatment are applied. Although frequently used, certain effects of these treatments on~     protein metabolism remain unclear. It is well known that maintenance of different tissues is~     determined by a dynamic balance between protein synthesis and breakdown rates, with~     temporary changes in either protein synthesis or breakdown allowing net protein accretion or~     loss. However, intra-articular injections with corticosteroids as a conservative treatment~     are thought to have several negative consequences thereby potentially affecting protein~     metabolism of different musculoskeletal tissues. In addition, though protein supplementation~     has shown to be an effective nutritional strategy in stimulating muscle protein synthesis,~     it remains unclear to what extent other musculoskeletal tissues are able to respond to~     dietary protein supplementation. Therefore, the current study assesses the impact of~     intra-articular corticosteroid injections and preoperative protein supplementation on~     protein synthesis in different musculoskeletal tissues of the knee.~      Objective: To investigate the effect of preoperative protein supplementation and~     corticosteroid injections on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament,~     menisci, and cartilage protein synthesis of the OA knee.~      Study design: Randomized, parallel (three groups) study design. Each of the two intervention~     groups will be compared to the control group separately.~      Study population: 36 adults (45-75 y) with OA of the knee undergoing TKR. Intervention:~     Intra-articular injection of betamethasone (2ml; 4mg/ml) and bupivacaine (8ml; 5mg/ml) or~     daily 40 g of pre-sleep protein two weeks before TKR, or no intervention.~      Main study parameters/endpoints: Primary study parameters include protein synthesis rates~     and enrichments of Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and~     cartilage. Secondary parameters include whole-body protein synthesis, breakdown, oxidation,~     and net balance.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks involved in participating in this study are minimal. There are no~     potential effects known for the ingestion of protein. The corticosteroid injection is~     standard care in conservative treatment of osteoarthritis. Risks are small and limited to~     the knee itself, such as cartilage degeneration or joint destruction. Muscle biopsies and~     tissue collection will be performed during the surgical procedure.~   "
1522|NCT03037281|"~     Nociceptin is a protein found in the body, with a number of functions in the central nervous~     system, blood vessels and the gut. There is evidence that it may have a role in controlling~     the immune response to infection, and may act as a link between the brain and immune system.~      In infection, or after surgery, there is an increase in nociceptin, and subjects greater~     elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune~     system may produce nociceptin, although it is not yet known which cells are capable of~     producing it, and what switches on production.~      This study aims to determine~        1. Which cells of the immune system can produce nociceptin~        2. If there is a difference in the ability to produce nociceptin between healthy~          volunteers and patients with severe infections~   "
1523|NCT03037268|"~     1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the~          grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy~          Trials Outcomes in the Emergency Department (FOTO-ED) Study.~        2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked~          image reviewers' quality measurements and findings to images obtained with a~          commercially available ocular fundus camera and documented exam findings~   "
1524|NCT03037255|"~     This study aims to determine the extent to which pre-existing long-term conditions are~     associated with survival following a heart attack (acute myocardial infarction) using~     observational data from the UK's national heart attack register.~   "
1525|NCT03037242|"~     The results of this study will optimize the care for patients with a meniscus root tear.~     Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout~     technique is an effective treatment and will identify potential risk factors for poor~     clinical outcomes. In addition, investigators will determine if MRR is successful in~     delaying the radiographic progression of arthritis in the involved compartment.~   "
1526|NCT03037229|"~     Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in~     the identification of STEMI (ST Elevation Myocardial Infarction).~   "
1527|NCT03037216|"~     The purpose of this study is to find out whether exercise training leads to changes in the~     blood that are produced by exercised muscles and if these changes produce new hormones that~     affect the body's regulation of sugar and body weight.~   "
1528|NCT03037203|"~     This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending~     dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and~     PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult~     subjects with idiopathic PD.~   "
1529|NCT03037190|"~     The overall aim of this project is to investigate whether a gluten free diet after the onset~     of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same~     time prevent the development of Celiac Disease (CD) in these patients.~      Specific aims~      • To study whether gluten free diet during one year after the onset of diabetes influence~     the appearance and duration of clinical remission in children with Type 1 diabetes.~      New data show that a gluten free diet is beneficial concerning the insulin production after~     the onset of diabetes. The investigators want to investigate if gluten is a triggering~     protein for the destruction of the beta cell function after the onset of diabetes by~     comparing children who have a normal diet compared to children with a gluten free diet~     during one year after the onset of the disease.~        -  To study whether a gluten free diet during one year after the onset of diabetes prevent~          the development of Celiac Disease in these children and the impact of having two~          diseases It is known that it is almost 10 times more common that children with Type 1~          Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most~          of these children (6-7 %) develop CD after the onset of Diabetes and within 5 years.~          Based on our new data that CD is preventable to some extent the investigators plan to~          perform randomized controlled studies if it is possible to prevent or postpone CD by~          means after the onset of IDDM.~        -  To investigate the impact of gluten free diet on the regulation of autoimmune responses~          The investigators will test the hypothesis that gluten free diet in children with~          recent onset T1D will implement immune regulation and inhibit the activation of~          potentially autoreactive T cells.~   "
1530|NCT03037177|"~     Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between~     classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described~     in the literature. Investigators report the clinical characteristics and outcomes of a large~     retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a~     consensus established for the diagnosis.~   "
1642|NCT03035721|"~     This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy~     full-term infants by investigating effects on growth and gastrointestinal tolerance and by~     identifying any adverse effects.~   "
3041|NCT03017404|"~     To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection~     combination with cyclophosphamide and sequential treatment of docetaxel for patients with~     locally advanced breast cancer~   "
1531|NCT03037164|"~     Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood~     Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult~     patients who require RBC transfusion support.~      Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in~     regions where a substantial proportion of the population has been infected or is at risk of~     infection by the Zika virus (ZIKV), and the risk of asymptomatic infection among qualified~     blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV,~     the intent of the study is also to reduce the risk of transfusion-transmitted infections~     (TTI) in general, including transfusion related sepsis and other emerging or concurrent~     endemic pathogens (e.g. Dengue and Chikungunya), and to reduce the risk of TA-GVHD.~      As part of this treatment use study, additional data will be provided on the safety of~     INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.~   "
1532|NCT03037151|"~     This study will evaluate the safety and efficacy of combination treatment with grazoprevir +~     elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6~     (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV)~     infection.~   "
1533|NCT03037138|"~     Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling.~     The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis~     washed-out state.~   "
1534|NCT03037125|"~     Split crest technique is a technique for horizontal bone augmentation used in case of narrow~     alveolar ridges as an alternative to the more aggressive techniques such as onlay bone~     grafting, guided bone regeneration (GBR) and distraction osteogenesis~      The study goal is to evaluate whether if there will be any benefit of using platelet rich~     fibrin (PRF) with the split crest technique regarding bone width gain and healing response~     in comparison with split crest technique alone, where PRF is considered an autologous,~     growth factor containing material which is easy to collect and is of low cost.~   "
1535|NCT03037112|"~     Antibiotic overuse and misuse contributes to the development of antibiotic resistant~     infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in~     outpatient settings; most of which are for respiratory illnesses. It is estimated that 50%~     of these prescriptions are unnecessary. The most important factor that leads to~     overprescribing is inadequate parent-provider communication. This study will recruit~     providers and eligible parents of children 1-5 years of age. Parents in both arms will~     receive identical brief antibiotic education via tablet computers. Providers will be~     randomized to the parent-provider education or communication skills intervention arm and~     trained accordingly. Parent data will be collected via a tablet computer RedCap survey~     administered in the exam room prior and immediately following the child's visit. Additional~     data will be garnered from the medical record (antibiotic prescribing) and a 2-week~     follow-up telephone call with parents (re-visits and adverse drug reactions).~   "
1536|NCT03037099|"~     The main purpose of this study is to examine the effectiveness of enhanced GI-targeted~     nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.~     Sixty-six eligible participants will be randomized into two equal groups using a pragmatic~     randomized controlled trial design.~   "
1537|NCT03037086|"~     MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1~     expression and to assess the clinical characteristics and outcomes among NSCLC patients~   "
1538|NCT03037073|"~     For >60 years, succinylcholine is still being administered as a selective relaxant for rapid~     sequence intubation by anesthesiologists in many countries. It has been shown to possess~     unique features such as low cost, fast-acting, short half-life, safe metabolites, and~     causing excellent muscle relaxation for intubation. It has many side effects as well.~     Postoperative myalgia (POM), with an incidence rate of ~41%-92%, is one of the most common~     side effects of this drug and can take several days to cause significant discomfort in~     patients. However, its effect is felt more in the throat, neck, shoulder, and abdominal~     muscles and is common among patients with outpatient surgery. Due to its unknown real~     context of pathogenesis and in an effort to reduce the incidence and severity of~     succinylcholine-induced myalgia, various medications including nondepolarizing muscle~     relaxants, benzodiazepines, magnesium sulfate, opioids, gabapentin, and nonsteroidal~     anti-inflammatory drugs have been tested, with varying degrees of success.~      Duloxetine is an US Food and Drug Administration-approved analgesic used for various pain~     syndromes, including diabetic peripheral neuropathy and fibromyalgia. The underlying~     mechanism for duloxetine against these pain syndromes remains unclear, but it may involve~     three major central nervous system (CNS) targets: (1) serotonin transporter (Ki, 4.6 nM),~     (2) norepinephrine transporter (Ki, 16 nM), and (3) dopamine transporter (Ki, 370 nM). In~     the past, the antidepressant action was often thought to be the primary mechanism for its~     analgesic efficacy. This theory was addressed later by Path Analysis, and the result~     showed that duloxetine affects pain directly rather than indirectly through mood~     improvement. In addition to these multiple CNS targets, duloxetine, like the antidepressant~     amitriptyline and the local anesthetic bupivacaine, blocks voltage-gated Na+ channels.~     Because neuronal Na+ channels are present in both CNS and peripheral nervous systems, such a~     finding expands the possible analgesic action and locus of duloxetine.~   "
1539|NCT03037060|"~     There is a need to better understand the mechanisms underlying alcohol use and dependence in~     order to advance the clinical treatment of alcohol dependence. Here, the investigators will~     use Positron Emission Tomography to determine if there is an up-regulation of D3 receptors~     in the brains of subjects with alcohol use disorders. The investigators will also~     investigate the relationship between D3 binding and major phenotypes associated with alcohol~     use disorders, namely: alcohol cue induced craving and motivation to self-administer alcohol~     in the laboratory.~   "
1540|NCT03037047|"~     This parallel, double blind, randomized, controlled, multi-center study will evaluate the~     efficacy and safety of salvianolate injection in elderly patients with unstable angina~     pectoris.~   "
1541|NCT03037034|"~     Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive~     patients who had clinical indications for lesion removal. Following the injection around a~     submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled~     away to form a tent. The tissue was dissected using an electrocoagulating current. In~     brief, the tumor was dissected from the muscularis propria layer and then carefully removed~     using forceps. Demographic data, indication for intervention, safety of the procedure and~     follow‐up will be assessed.~   "
1643|NCT03035708|"~     This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study~     designed to assess the effects of varenicline as compared with placebo on responses to in~     vivo alcohol cue exposure in the human laboratory setting.~   "
3065|NCT03017092|"~     Pilot study to test feasibility of delivering a motivational smoking cessation intervention~     to low income smokers via a computer tablet.~   "
1542|NCT03037021|"~     The overall goal of this proposed project is to 1) increase co-management between sickle~     cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU)~     which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death;~     3) identify and link patients not receiving primary or SCD specialty care to care, and 4)~     shift healthcare use from EDs and hospitalizations to primary and specialty co-management.~     Many persons with SCD experience a poor quality of life, serious medical complications and~     frequent painful events that require treatment from SCD specialty care, primary care and~     emergency department (ED) providers. There are two dominating models of care in the United~     States; neither are ideal. Many people with SCD have all of their healthcare needs addressed~     by sickle cell specialists who do not typically provide primary care and are often~     geographically distant from the patients' home. Other sickle cell patients receive all of~     their care in EDs. Both models are inadequate and result in an alarmingly high number of ED~     visits for many patients. Current care models are neither cost efficient nor promoting~     optimal patient outcomes. To improve outcomes, the investigators will implement a new model~     of care for SCD using nurse care managers, web based-interactive algorithms, and test if~     additional patient provided coaching can improve outcomes.~   "
1543|NCT03037008|"~     Prospective study to evaluate a new technique. Comparison of perineal sonography in men~     before and after radical prostatectomy and in incontinent men after radical prostatectomy~     before and after operative treatment with male sling and comparison with pre- and~     postoperative functional MRI~      Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history~     of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).~      Exclusion: Patients with history of urinary incontinence before radical prostatectomy.~     Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.~   "
1544|NCT03036995|"~     Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is~     an acquired pigmentary disorder of the skin and mucous membranes that is characterized by~     circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4)~     inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and~     psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading~     to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes.~     Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for~     promoting melanogenesis and for inducing the differentiation and the proliferation of~     melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of~     Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo~     therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo.~     Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or~     slowly progressive for 3 months , seeking for treatment in the Department of Dermatology,~     University Hospital of Nice, France will be recruited into the study. The Patients are seen~     in consultation by the investigator, selection criteria are checked. All patients will~     receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks.~      From W24 to W48~        -  All responders* will receive narrow UVB treatment according the French clinical use~          i.e.twice weekly sessions of narrowband UVB for 24 weeks.~        -  All responders* will be randomized to receive either apremilast** 30mg BID or placebo.~             -  Response is defined as an increase of at least 30 % in the VASI score at W24~               compare to baseline **Responders initially randomized in the placebo arm will~               benefit of the titration At week 24, the non responders patients will stop the~               treatment and the study after the 4 weeks observationnal follow-up (W28).~      Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all~     subjects who complete the study (responders and non responders) or discontinue the study~     early.~   "
1545|NCT03036982|"~     This study will assess whether adaption of the Asthma Control Test (ACT) and childhood~     Asthma Control Test (cACT) for mobile devices improves rate of completion and improves~     control of asthma in children and adolescents~   "
1546|NCT03036969|"~     EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent~     conditions:~      Emergency Departments (EDs) are an important interface between primary and secondary health~     care sectors in Germany. The number of outpatient visits in the ED´s is still increasing.~     The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in~     Germany and will be investigated in this project.~   "
1547|NCT03036956|"~     The Precious study is likely to help determine the frequency (percentage) of subclinical~     hypothyroidism among pregnant women in Pakistan It will also help to determine the risk~     factors for developing subclinical hypothyroidism during pregnancy~   "
1548|NCT03036943|"~     The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine~     (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the~     differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform~     further work to investigate its use in breast cancer management.~   "
1549|NCT03036930|"~     This clinical trial studies how well recombinant human papillomavirus nonavalent vaccine~     works in preventing human papillomavirus-related cancer in adult women after kidney~     transplant. Vaccines made from peptides of human papillomavirus may help the body build an~     effective immune response to kill tumor cells. Giving booster vaccinations may make a~     stronger immune response and prevent or delay the recurrence of cancer.~   "
1550|NCT03036917|"~     This study aims to investigate the cognitive function of patients in the opioid reduction~     programme at the multidisciplinary pain centre at Zealand University Hospital Køge.~      The patients will be tested before, halfway through, and after the programme.~   "
1551|NCT03036904|"~     This is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in~     combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.~   "
1552|NCT03036891|"~     The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid~     receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of~     gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis~     symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The~     hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who~     are taking opioids as well as improves their gastric emptying while maintaining control of~     patient's pain. This study will entail an initial double-blind, randomized,~     placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with~     opioid-related gastroparesis followed by a 4-week open label period to demonstrate the~     improvement in symptoms and gastric emptying with naloxegol.~   "
1553|NCT03036878|"~     To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for~     osteochondral lesions~   "
1554|NCT03036865|"~     Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial~     conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single~     ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy~     adult male and female participants.~   "
1559|NCT03036800|"~     A two year, parallel, two phase, two group, open-label, randomized controlled trial design~     for patients with severe and complex obesity who are referred to Tier 3 obesity service~     (including patients who are referred to Tier 3 service as part of the bariatric surgery~     pathway). This first phase of the study (first 52 weeks after randomization) will determine~     whether the targeted use of LIRA 3 mg in combination with the standard care provided in Tier~     3 setting will result in more participants attaining ≥15% weight loss compared to the~     standard care alone in a Tier 3 service. The second phase of the study will aim to provide~     some evidence whether the patients who will achieve ≥15% weight loss of baseline weight~     during the first phase of the study, will be able to maintain ≥15% weight loss for another~     52 weeks with the use of standard care plus LIRA 3mg compared to the standard care alone.~     Further, budget impact, cost-effectiveness, improvement in obesity-related co-morbidities,~     complementary aspects of safety, effectiveness and treatment satisfaction of both treatment~     groups will be assessed and compared.~   "
1560|NCT03036787|"~     Infant born preterm have an increased risk of adverse long-term developmental outcomes.The~     risk associated with preterm birth increase as gestational age decreases, and vulnerability~     remains in extremely- very preterm (<32 weeks) and moderate- late preterm (>32 weeks). There~     are many studies in the literature showed that the prevalence of developmental delay~     increases with premature birth. However, there is no study in the literature investigates~     long term follow up motor and cognitive development in subgroups of preterm infants . Hence~     the aim of this study is to evaluate the differences in motor and cognitive development in~     moderate-late (>32 weeks) and extremely-very preterm infants.~   "
1561|NCT03036774|"~     The main objective is to compare the frequency of a  full stomach  in diabetic patients~     compared with a control population, all the patients having followed the instructions of~     preoperative fast.~   "
1562|NCT03036761|"~     The aim of the study is to show that auriculotherapy decreases the number of days with~     painful episodes of migraines and not migrainous headaches after 3 months of treatment~   "
1563|NCT03036748|"~     The aim of this study is to determine if amiloride, a diuretic drug, is capable of~     increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney~     transplant recipients with proteinuria compared to normoalbuminuric transplant patients.~   "
1564|NCT03036735|"~     The study is designed to evaluate if addition of the steroid to the spacer / stent will~     improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.~   "
1565|NCT03036722|"~     This proposed randomized double blinded, placebo-controlled, parallel trial; with two arms,~     in females aged 50-70 years, volunteers will be postmenopausal with a BMI between 25-35~     kg/m2. This study aims to determine the benefits of phytoestrogen-rich flaxseeds on~     decreasing bone turnover in postmenopausal women aged over 50 years.~   "
1566|NCT03036709|"~     This is a placebo-controlled clinical trial of VRC01 administration and analytic treatment~     interruption (ATI) in adults who began antiretroviral therapy (ART) during early acute HIV~     infection (Fiebig stage I to III). Eligible volunteers will be randomized in a 3:1 ratio to~     either VRC01 or placebo, with randomization stratified by Fiebig stage. Volunteers who are~     receiving ART with a non-nucleoside reverse transcriptase inhibitor (NNRTI) will undergo 4~     weeks of protease inhibitor (PI) substitution for their NNRTI prior to randomization. ATI~     will begin the day of the first dose of either VRC01 or placebo. Participants will be~     monitored closely for HIV viremia and other pre-defined criteria for ART resumption.~     Administration of the study agent (VRC01) every three weeks will be discontinued after 24~     weeks or if ART is resumed, whichever occurs first. Volunteers who remain virally suppressed~     without laboratory or clinical indication for ART resumption at 24 weeks will continue~     intensive monitoring for ART resumption criteria for an additional 24 weeks, during which~     time no VRC01 or placebo will be administered.~   "
1567|NCT03036696|"~     Interview pregnant and lactating mothers in the Gainesville, FL area to optimize; clinical~     study recruitment and retention, patient-centered outcomes, and stool collection procedures.~   "
1568|NCT03036683|"~     This study investigates the effect of upregulating prefrontal cortex activity on~     risk-taking, and antisocial and aggressive behavior in violent offenders. In the~     double-blind, randomized controlled trial, using a within-subject crossover design, each~     participant will undergo anodal transcranial direct current stimulation of the right~     dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural~     activity and behavioral responses to tasks assessing risk-taking and aggressive behavior~     will be recorded. The effect of tDCS on violent offenders will also be assessed in~     comparison to age and gender-matched healthy controls.~   "
1569|NCT03036670|"~     EGPA (Eosinophilic Granulomatosis with Polyangiitis, previously Churg-Strauss syndrome) is a~     rare vasculitis, characterised by asthma, rhinosinusitis and eosinophilia. There has~     previously been confusion around diagnostic criteria, with multiple sets of classification~     criteria being used inappropriately for diagnosis. The ERS formed a taskforce to produce~     specific diagnostic criteria, and these divided the Churg-Strauss Syndrome cohort into two~     groups - vasculitic EGPA and tissular Hypereosinophilic Asthma with Systemic Manifestations~     (HASM). It is not known if the groups separated by the diagnostic criteria are also~     separated in clinical symptomatology, or if their disease course varies, and this could have~     significant impact on management and further research.~   "
1570|NCT03036657|"~     Thus study aims to characterize the local, nerve-specific effects of acupuncture on the~     median and ulnar nerves in the forearm, using nerve conduction studies and quantitative~     sensory testing. All participant will have carpal tunnel syndrome and the affected median~     nerve will be compared to the healthy ulnar nerve. Additionally, we aim to compare the~     local, nerve-specific effect of manual acupuncture to that of low-frequency~     electroacupuncture and of high-frequency electroacupuncture.~   "
1644|NCT03035695|"~     The aim of this study was to evaluate the efficacy and safety to use external haemostatic~     between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as~     a pre hospital acute hemorrhagic control in trauma in ambulance settings.~   "
1645|NCT03035682|"~     The purpose of this study is to determine the impact a mobile health application has on~     adherence to a physical therapy home exercise program and its effect on functional outcomes.~   "
1646|NCT03035669|"~     The present study will investigate the effects of a mindfulness training on emotion~     regulation and social cognition, using several psychological, behavioral,~     psychophysiological and neuroimaging methods.~   "
1571|NCT03036644|"~     Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a~     liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,~     nicotine to form an aerosol (vapor) that is inhaled (i.e. vaped). Scarce and conflicting~     data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to~     determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization~     at high temperature in comparison to tobacco cigarette smoking on several advanced~     cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.~     Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be~     quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative~     stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the~     first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco~     cigarette smoking on the cardiovascular system in relation to vaporization temperature,~     nicotine delivery and oxidative stress.~      Aims of the study: This study tests the following hypotheses: 1) acute high temperature~     vaporization of propylene glycol and vegetable glycerin has no deleterious effects on~     cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma~     and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes~     vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers~     increases superoxide anion production.~   "
1572|NCT03036631|"~     The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions~     whether sedation with intubation and paralytics is feasible and whether it delays the time~     to recanalization in comparison with conscious sedation alone. As a pilot registry, it is~     anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18~     months. Following enrollment, data will be collected prospectively from medical records and~     from patients' visits.~   "
1573|NCT03036618|"~     Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and~     possible properties against cardiovascular diseases and for improving gut health. There are~     some animal studies to suggest that some important class of compounds like fibre,~     antioxidants and protein, found naturally in quinoa, have beneficial effects against markers~     of cardiovascular diseases. However, the effects of quinoa on humans has rarely been~     investigated. This study will investigate the effects of daily consumption of quinoa for~     four weeks on markers of cardiovascular risk, including blood cholesterol and resting blood~     pressure, and on gut health in a randomised cross-over study design.~   "
1574|NCT03036605|"~     Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,~     prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to~     pain, therefore the most common problems after surgery are postoperative pain and anxiety~     during removal of the nasal packing. Lots of methods have been tried to control this pain~     (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,~     local anesthetics infiltration into nasal packing).~      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.~     Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong~     analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces~     postoperative nausea and vomiting incidance.~   "
1575|NCT03036592|"~     The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B)~     single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the~     deleterious effect in a vulnerable population with regular exposure to concurrent high~     melatonin and food intake as late night eaters (those having dinner within 2.5 h before~     their usual bed time). With the results from this study, we expect to advance our~     understanding of the role of endogenous melatonin on glucose metabolism in late night eaters~     and carriers of the MTNR1B risk allele, with potential implications on the guidelines to~     mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk~     allele.~   "
1576|NCT03036579|"~     This investigation will be a clinical trial to study the performance of a newly developed~     high strength ceramic material for crowns. The ceramic has been approved by the FDA for~     patient treatment. A computer technique will be used to fabricate the crowns in a single~     appointment without the need for a temporary crown or second appointment. Two adhesive resin~     cement techniques will be used to hold the crown to the tooth and they will be evaluated for~     creating sensitivity to the tooth. The purpose of the study is to measure how well the high~     strength crowns function over an extended period of time.~   "
1577|NCT03036566|"~     This investigation will be a clinical trial to study the performance of a high strength~     ceramic material for bridges to replace missing teeth. The ceramic material has been~     approved by the FDA for patient treatment. A computer technique will be used to make the~     bridges. The bridges will be cemented using an adhesive resin cement (MultiLink~     Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months,~     1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the~     study is to measure how well the high strength bridges function over an extended period of~     time.~   "
1578|NCT03036553|"~     Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high~     socio-economic costs, with many negative effects on quality of life. CMP affects the ability~     to perform work, social, recreational and domestic tasks, changing the mood and~     concentration of this population. Despite the worldwide prevalence and socioeconomic burden~     of CMP, a clear understanding of its etiology and pathogenesis remains elusive.~      Aims:~      (i) to analyze the possible level of association between pain-related fear, fear of~     movement, self-efficacy, and pain acceptance with pain intensity and disability at the start~     of the study and prospectively evaluate its predictive function; (ii) to evaluate the~     possible mediating role of fear of movement and self-efficacy in the relationship between~     pain-disability in patients with CMP.~   "
1579|NCT03036540|"~     The patients admitted in hospital who had midline catheter inserted in upper limb are~     followed-up for the presence of complications related to catheter introductions. The~     symptoms and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by~     sonography examination. In the selected group of asymptomatic patients sonography~     examination is done 8 to 10 days after cathether insertion in order to detect the incidence~     of the asymptomatic thrombosis~   "
2157|NCT03028974|"~     The purpose of the study is to get a better understanding of the natural and adaptive immune~     response to the flu virus and to compare the immune cell responses to FDA-licensed flu~     vaccines in nasal mucosal cells and in blood.~   "
1580|NCT03036527|"~     Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting~     quality of life after spinal cord injury. The insights of how activity-based training~     affects bladder function may prove to be useful to other patient populations with bladder~     and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as~     stimulate investigations of training's effects within other systems such as bowel~     dysfunction. Locomotor training could help promote functional recovery and any insights~     gained from these studies will enhance further investigation of the effect of bladder~     functioning after spinal cord injury. In addition, as suggested by a study of one of our~     initial participants, a reduction in the use and/or dosage of medication to enhance sexual~     function is a possible outcome, medications which carry risks and side effects.~   "
1581|NCT03036514|"~     In this study, numeric rating scale (NRS) and side effects are measured after usage of a~     sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled~     analgesia (PCIA).~   "
1582|NCT03036501|"~     This is an open-label, non-randomized study investigating the excretion balance, PK and~     metabolism of a single oral dose of [14C]-labeled RO7034067 in healthy male participants.~     This study will assess the characterize mass balance, routes and rates of elimination of~     [14C]-labeled RO7034067, using conventional analytical methods and assess the~     pharmacokinetics of total drug related [14C]-radioactivity, RO7034067 and its metabolite(s).~   "
1583|NCT03036488|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)~     plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs~     placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).~      After a screening phase of approximately 28 days, each participant will receive neoadjuvant~     study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the~     randomization schedule for approximately 24 weeks (8 cycles). Each participant will then~     undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant~     study treatment. After definitive surgery, each participant will receive adjuvant study~     treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following~     adjuvant study treatment, each participant will be monitored for safety, survival and~     disease recurrence.~      The primary study hypothesis is that pembrolizumab is superior to placebo, in combination~     with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or~     Event-free Survival (EFS), in participants with locally advanced TNBC.~   "
1584|NCT03036475|"~     The aim of this study is to evaluate a new method for the localization of breast cancer~     sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard~     techniques with radio-isotopes.~   "
1585|NCT03036462|"~     International, prospective, multi-centre, double-blind, parallel group, randomised,~     controlled, interventional trial.~      After initial screening period (up to 30 months) eligible patients will be randomised (1:1)~     to i.v. FCM or i.v. placebo (0.9 % NaCl-solution) administration on top of usual care.~   "
1586|NCT03036449|"~     The purpose of this study is to determine whether an educational program for caregivers~     associated with convenient tools is effective to reduce medication preparation and~     administration errors in the Neonatal Intensive Care Units (NICU).~   "
1587|NCT03036436|"~     Participants will take part in a 12 week intervention, with at least one follow up at 24 +/-~     2 weeks. Each participant will be provided with support, motivation and professional~     guidance about improving physical activity (PA) levels and will be given a commercially~     available PA tracker. The PA tracker will also include a smartphone or web-based~     application, where participants can upload their exercise performed each day, and keep up to~     date with their goals using their smartphone or by logging on to their computer. The aim of~     the study is to find out how useful and effective technology with support from a healthcare~     professional is in helping cancer survivors to become more physically active.~      This study will measure objective PA levels of the participants at the start of the study~     and at the end. The acceptability of using this intervention to promote PA in cancer~     survivors will also be investigated.~   "
1588|NCT03036423|"~     The purpose of this study is to test whether certain brain training activities can promote~     cognitive, emotional, and physical health in caregivers of a spouse with dementia. Numerous~     studies show that family dementia caregiving can be stressful, and can increase mental and~     physical health risks. This study aims to understand how to reduce those risks.~   "
1589|NCT03036410|"~     Communication on telephone is challenging for people with hearing loss. For hearing aid~     users, for instance, the inventions for improving speech intelligibility on the phone range~     from an integrated tele coil and individual hearing programs to specially designed phone~     devices. No formal studies involving these devices have been carried out with CI users.~      Thus, this comparative study includes hearing aid as well as CI and bimodal users to~     evaluate different hearing solutions for communication on telephone in terms of~     intelligibility and ease of use.~   "
1590|NCT03036397|"~     Background:~      Arginine vasopressin (AVP) is a hormone made in the body. It can make negative feelings~     stronger. The way AVP is regulated may be abnormal in people who have mood and anxiety~     disorders. SRX246 is a new drug that can block a receptor for AVP on brain cells.~     Researchers want to study how this drug affects the way people respond to threat and~     anxiety.~      Objectives:~      To see if the new drug SRX246 affects how people respond to the threat of an unpleasant~     shock.~      Eligibility:~      Healthy adults ages 21-50~      Design:~      Participants will be screened in another protocol.~      Participants will have 4 visits over 4 weeks.~      At visit 1, participants will have small electrodes taped to their arm to give shocks.~     Electrodes on the arm, chest, and face will measure sweat, heart rate, and blinking.~     Participants will hear loud noises and get test shocks for about 15 minutes.~      At the other 3 visits, participants will have some or all of these tests:~        -  Blood and urine tests~        -  Heart tests~        -  Suicide screen~      At each visit, participants will answer questions about their mood and anxiety. They will~     identify emotions in pictures. They will have shock testing for 40 minutes: they will hear~     loud sounds through headphones and get shocks.~      Participants will take the study pill 2 times a day for a week after visit 1 and a week~     after visit 3. One week it will be SRX246. The other week it will be a placebo.~      Participants may be contacted daily to remind them to take the medicine.~      Participants will have either a follow-up visit or follow-up phone call.~   "
1591|NCT03036384|"~     Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most~     commonly used for spinal injection in cesarean section. Nevertheless, its use often results~     in a long duration of motor nerve block and a haemodynamical instability. Recently~     developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good~     alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric~     prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants~     potentiate the effect of the local anesthetics while decreasing their dose-related side~     effects, the aim of this study is to determine the ED95 of hyperbaric prilocain 2% with~     sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual~     Reassessment Method (CRM)~   "
1592|NCT03036371|"~     The goal of this pilot study is to test the procedural aspects of the behavioral tests and~     the exercise components of the study. This includes establishing typical scores for anxiety~     patients in these behavioral tests, and administering and coaching anxiety patients in an~     at-home exercise regimen. This pilot study will produce the information necessary to design~     a larger future study including both patients and healthy control participants.~   "
1593|NCT03036358|"~     The effect of teledermatology on length of hospital admission, length of stay, 30 day~     readmission rate, and antibiotic use in patients presenting with cellulitis vs~     pseudocellulitis in an academic emergency department setting.~   "
1594|NCT03036345|"~     Surgery to the shoulder may be performed with patients seated upright in a position known as~     the Beach Chair Position (BCP). This position has certain advantages compared to~     alternative surgical positions (e.g. side lying) in some situations. However, it has been~     found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as~     a result of the combined effects of gravity and anaesthesia. This can result in~     complications following surgery such as some memory loss and confusion. Rarely, more serious~     complications have been reported in the past including death and stroke.~      Due to these reported complications the use of cerebral oximetry during shoulder surgery~     in the BCP has become more common. Before and during surgery, a monitor placed on the~     patients forehead measures the amount of oxygen present in the brain to help control this to~     an acceptable level. A number of monitors are now commercially available. Two monitors are~     commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However,~     the actual relationship between the supply of oxygen to the brain during surgery and the~     chance of later developing problems with memory and thinking (known as post operative~     cognitive decline - POCD) is not clear. It is also not known if one monitor is more~     accurate than another at predicting these complications.~      Therefore, the main aim of this study is to examine the relationship between cerebral oxygen~     levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and~     thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to~     measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of~     other key clinical variables (e.g. blood pressure, nausea, body fat etc).~   "
1595|NCT03036332|"~     The present study aimed to determine the effects of 16 weeks of aerobic interval training on~     quality of life and a set of clinical biomarkers.~   "
1596|NCT03036319|"~     As individuals grow older, a number of factors can reduce our cognitive (or thinking)~     abilities such as normal aging, neurodegenerative diseases, and cardiovascular disease.~     This study will evaluate whether cognitive rehabilitation and transcranial electrical~     stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to~     methods that are used to improve tasks people have trouble doing in everyday life.~     Transcranial electrical stimulation uses small amounts of electricity to try to alter brain~     functioning. These approaches may help improve cognitive abilities like attention, learning,~     memory, finding words, and problem solving as well as everyday functioning. The goal of this~     study is to identify how to best use these methods, either alone or in combination.~   "
1597|NCT03036306|"~     The purpose of this study is to assess the safety and local tolerability of two different~     concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a~     day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition,~     the absorption and elimination of profiles of this topically applied product will be~     determined through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo~     will be done but are considered exploratory.~   "
1598|NCT03036293|"~     The purposes of this study are:~        -  To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in~          patients with somatoform, stress-related and other neurotic disorders.~        -  To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8~          tablets daily, both for 12 weeks) in the treatment of anxiety in patients with~          somatoform, stress-related and other neurotic disorders.~   "
1599|NCT03036280|"~     The name of this trial is MissionAD2. This 24-month treatment, multicenter, double-blind,~     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's~     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early~     stages of mild AD will be conducted to evaluate the efficacy and safety of E2609~     (elenbecestat).~   "
1600|NCT03036267|"~     Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured~     adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn~     may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A~     brief shared decision-making intervention for use by primary care providers in Federally~     Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve~     asthma control in this high-risk patient group.~   "
1601|NCT03036254|"~     An urgent need exists to identify effective interventions to arrest or reverse dementia and~     cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will~     investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive~     functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive~     impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen~     therapy effects on cognition in diabetes. The potential to preserve, or even enhance,~     cognition in elderly at high risk of cognitive decline and dementia has major implications~     for the affected individuals and their support systems that bear the social and financial~     burdens of long-term caregiving.~   "
1602|NCT03036241|"~     The purpose of this study is to determine whether the use of drug-eluting balloons is~     effective in the treatment of (re)stenosis in dialysis fistulae.~   "
1607|NCT03036176|"~     Children with severe acute malnutrition (SAM) are at serious risks that compromise their~     growth and development. Studies have shown the benefits of psychosocial intervention in~     mitigating the negative consequences of SAM. However, such intervention studies have~     targeted the critical period in child development and thus focused on children under three~     years of age. Dietary rehabilitation is usually included as part of the intervention~     package. Moreover, these young children in such studies customarily obtain more care than~     older ones and have access to breast milk, more frequent interaction with mother and other~     caregivers in the family. Therefore, effects of psychosocial interventions targeting such~     age groups may be different for older children. Much is not known if children older than~     three years of benefit from similar interventions, and if family-based~     psychomotor/psychosocial intervention can benefit SAM children in low income contexts such~     as Ethiopia where access to balanced diet remains hardly possible. In Ethiopia, one of the~     poorest countries in the world, many children are admitted to hospital for treatment due to~     SAM. The nutritional rehabilitation unit at hospitals provide dietary treatment to the SAM~     children who are also treated for related illnesses and complications. Once discharged from~     hospital, however, the SAM children return to the same poor home environments with~     inadequate care and unbalanced diets. The main objective of this study was to evaluate the~     effect of play-based family-centered psychomotor/psychosocial stimulation on linear growth,~     nutritional status and developmental outcomes of under-six SAM children in the Jimma Zone,~     south west Ethiopia. This was done by randomly assigning the SAM children admitted to Jimma~     University's Specialized Referral Teaching Hospital into control and intervention groups.~     Both groups were receiving the routine medical and dietary treatment services. The~     intervention group additionally received play-based psychomotor/psychosocial stimulation.~     Caregivers, supported by periodic visits made to their homes, continued the simulation.~     Measurements were taken after six months of home follow-up. It was hypothesized that the~     intervention would significantly improve some of the developmental skills of these children,~     and that the effect may be age-dependent.~   "
1608|NCT03036163|"~     Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending~     dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after~     single and multiple oral administration~   "
1609|NCT03036150|"~     The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and~     cardiovascular mortality in patients with chronic kidney disease~   "
1610|NCT03036137|"~     Relating the electroencephalogram findings of patients with tinnitus before and after a~     therapeutic modality is still scarce in the literature, especially with neuromodulatory~     methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study~     is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on~     patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with~     tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS~     in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and~     the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n~     = 18) will be recruited for comparative purposes of brain electrical activity with and~     without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial~     direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be~     assessed before and after intervention by electroencephalogram, Acuphenometry, Visual~     Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of~     volunteers will also be performed after 1 month of the end of treatment with tDCS.~   "
1611|NCT03036124|"~     The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of~     worsening heart failure or cardiovascular death in patients with chronic heart failure with~     reduced ejection fraction.~   "
1612|NCT03036111|"~     Trimebutine acts through smooth muscle relaxation. It is presumed that the topical~     application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure~     by relaxing the internal anal sphincter spasm.~   "
1613|NCT03036098|"~     The purpose of this study is to determine whether an investigational immunotherapy nivolumab~     in combination with ipilimumab is more effective than standard of care chemotherapy in~     treating patients with previously untreated inoperable or metastatic urothelial cancer.~   "
1614|NCT03036085|"~     The aims of the study are to compare the effectiveness and postoperative outcomes of~     liposomal bupivacaine vs plain bupivacaine following video-assisted thoracoscopic surgery.~     The investigators' hypothesis is that liposomal bupivacaine will decrease the postoperative~     pain and will be associated with more favorable postoperative outcomes when compared to~     plain bupivacaine following video-assisted thoracoscopic surgery.~   "
1615|NCT03036072|"~     This is an unblinded, single center, randomized study of infants with congenital heart~     disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed~     rewarming intervention or to the standard of care (strict normothermia).~   "
1616|NCT03036059|"~     The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation~     sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6~     rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is~     Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In~     Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many~     areas, transmission has persisted in some implementation units that had experienced 15 or~     more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and~     sleeping under insecticidal nets have significantly accelerated transmission interruption in~     some settings of high transmission intensity. Thus, it is evident that new intervention~     strategies could eliminate residual infection in areas of persistent transmission and speed~     up the LF elimination process. This study therefore seeks to test the hypothesis that~     biannual treatment of LF endemic communities will accelerate interruption of LF~     transmission.~      Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The~     interventions will be yearly or twice-yearly MDA delivered to entire endemic communities.~     Allocation to study group will be by clusters identified using the prevalence of LF.~     Clusters will be randomised to one of two groups: receiving either (1) annual treatment with~     IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The~     primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional~     surveys. Entomological assessments will also be undertaken to evaluate the transmission~     intensity of the disease in the study clusters. Costs and cost-effectiveness will be~     evaluated. Among a random subsample of participants, microfilaria prevalence will be~     assessed longitudinally. A nested process evaluation, using semi-structured interviews,~     focus group discussions and a stakeholder analysis, will investigate the community~     acceptability, feasibility and scale-up of each delivery system.~   "
1617|NCT03036046|"~     Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.~      A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for~     chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for~     >10 days will be treated. F901318 will be given in conjunction with fluconazole or~     posaconzaole in order to assess safe treatment regimens for both combinations.~   "
1618|NCT03036033|"~     This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation~     device in the treatment of patients who have reduced ability to open their hand due to~     weakness after an acute stroke.~   "
1659|NCT03035500|"~     This clinical trial studies how well a long-term follow-up works in patients with prostate~     cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical~     questions, describe health-related quality of life and long-term complications related, and~     facilitate future studies focusing on interventions to improve health status and~     health-related quality of life in prostate cancer survivors.~   "
1619|NCT03036020|"~     The main aim of the NASPP study is to assess the efficacy and safety of the prehospital~     diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate~     that anesthesiologists trained in pre-hospital critical care may perform acute stroke~     diagnostics by clinical assessment and CT scan interpretation and integrating these skills~     in the already existing organizational frame of the Norwegian prehospital EMS system.~      NASPP will systematically explore the Norwegian model of prehospital acute stroke~     diagnostics prior to the implementation of prehospital thrombolytic stroke treatment. NASSP~     will equip a regular ambulance staffed with a specially trained anesthesiologist and a~     specialized nurse. NASPP will perform the clinical part of the study in close co-operation~     with Østfold Hospital, Fredrikstad.~   "
1620|NCT03036007|"~     Background: Patients suffering residual disability after anterior decompression and fusion~     (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or~     neck-specific exercises (NSE). Currently, we lack data for the success of either approach.~     There is also a knowledge-gap concerning the use of internet-based care for chronic neck~     pain, inclusive of cervical disc disease. The scarcity of these data, and the high~     proportion of patients with various degrees of incapacity following ACDF, warrants increased~     efforts to investigate and improve cost-effective rehabilitation.~      Objective: To investigate the effectiveness of a structured, internet-based NSE program,~     versus PPA following ACDF surgery.~      Methods: This is a prospective, randomised, experimental, longitudinal multicentre study,~     that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI)~     following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs~     following attendance at routine clinical appointments, scheduled for 3-months post-surgery.~     Patients are then randomised to one of two groups (70 patients/group), scheduled for a~     3-month treatment of either internet-based NSE or PPA. Questionnaires on background data,~     pain and discomfort, physical and mental capacity, satisfaction with care, and health and~     workplace factors are completed, with physical measurements of neck-related function~     performed by independent test leaders blinded to randomisation. Measurements are performed~     at inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up.~     Radiography will be completed at the 2-year follow-up. Preoperative data will be collected~     from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and~     sick leave will be requested from the relevant national registers.~   "
1621|NCT03035994|"~     Altered loading is a causative factor for the development of knee osteoarthritis following~     anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an~     effective intervention to manipulate altered mechanical loading about the knee. The purpose~     of this study is to 1) determine if ACLR participants are able to acquire and retain various~     loading patterns using real-time biofeedback, 2) determine the effect of altered loading on~     lower extremity biomechanics during walking gait, and 3) determine the effect of altered~     loading on biochemical markers of collagen turnover and inflammation during walking gait.~   "
1622|NCT03035981|"~     Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,~     due to rapid digestion of starch into glucose. The specific properties of starch within~     these foods has been studied for the purpose of slowing their digestion rate and improving~     related physiological outcomes, such as gastric emptying rate. The current study~     investigated the relationship among starch digestion, gastric emptying rate and satiety in~     white and brown rice.~   "
1623|NCT03035968|"~     Stroke is the major cause for permanent disability in adults. It is still unclear, which~     physiotherapeutic approaches are most effective. The Bobath-concept is one of the most~     widely used approaches in stroke rehabilitation within the western world, although several~     studies have failed to demonstrate superiority and showed partially even inferiority~     compared to other physiotherapy approaches. The Vojta therapy is based on a completely~     different approach - the reflex locomotion. However to date no study has been performed for~     stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional~     physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT~     will be the first trial to investigate improvement of postural control due to Vojta therapy~     in early rehabilitation of stroke patients, which is a very new approach in~     stroke-rehabilitation.~   "
1624|NCT03035955|"~     The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum~     counts and disease condition via a split face design in approximately twenty patients with~     mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with~     azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement~     in lesion count and redness.~   "
1625|NCT03035942|"~     The aim of this study is to evaluate not only the occurrence of side effects, but the~     quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia~     with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment~     of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg),~     dexamethasone (8mg) or placebo.~   "
1626|NCT03035929|"~     In this pilot study, the investigators will determine the response of the natriuretic~     peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid~     medication). The goal of the proposed project is to generate preliminary data that will be~     used to develop power calculations, inform cutoff ranges, and inform the timing of the NP~     response for larger subsequent studies aimed at developing a diagnostic test for NP~     deficiency, which has important implications for cardiometabolic risk. The investigators~     propose a pilot study in 10 healthy lean individuals.~      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)~     responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.~      Hypothesis: Determination of the NP responses (the range and time course of changes in NP~     levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency~     of blood sampling in a definitive prospective study designed to understand the diagnostic~     values/cutoffs of a diagnostic test, as well as enable investigators to perform a sample~     size calculation for a definitive prospective study.~   "
1627|NCT03035916|"~     This study evaluates the effect of transversus abdominis plane(TAP) block combined with~     general anesthesia on perioperative stress response in patients undergoing radical~     gastrectomy. One third of participants will receive TAP block combined with general~     anesthesia, another one third of participants will receive epidural anesthesia combined with~     general anesthesia, while the rest will receive only general anesthesia.~   "
1628|NCT03035903|"~     The goal of this clinical protocol is to perform a randomized crossover study to determine~     the energy cost of holding the MedGem® device above a person's normal resting metabolic rate~     (RMR) compared to not holding the MedGem® device.~   "
1629|NCT03035890|"~     This study includes the additional use of radiation therapy in combination immunotherapy in~     order to determine whether the radiation may improve the response of non-small cell lung~     cancer to immunotherapy and to monitor any side effects.~   "
1630|NCT03035877|"~     This study's purpose is to examine the effectiveness of a promising intervention for~     emerging adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in~     achieving the ultimate outcome of reduced criminal activity. The study will also examine~     that effect on intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful~     activity (increased educational success, employment and housing stability; decreased~     antisocial peer involvement and relationship conflict); 3) and greater improvement in~     self-regulation (self-efficacy, goal directedness and responsibility taking). The~     intervention to be tested is Multisystemic Therapy-Emerging Adults (MST-EA). MST-EA is an~     adaptation of MST, a well-established, effective intervention for antisocial behavior in~     adolescents.~   "
1631|NCT03035864|"~     The proposed phase II study is a single-centre, randomized, double masked, parallel arm,~     vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF~     eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who~     underwent cataract and corneal refractive surgery, both known to damage the corneal sensory~     nerve plexus.~      After confirmation of inclusion and exclusion criteria all eligible patients will be~     randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study~     treatments administration with 4 weeks Follow-up.~   "
1632|NCT03035851|"~     The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative~     economic burden of $800 billion by 2038. Effective prevention of dementia at a population~     level will need to include lifestyle factors such as promoting higher levels of physical~     activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and~     cognitive decline, but the mechanisms by which physical activity exerts its protective~     effect on the brain remain unknown. Motivated by the need to develop strategies to prevent~     and treat AD and related dementias (ADRD), the investigators' overall research goal is to~     discover why the aging brain develops ADRD. To achieve this goal the investigators adopt a~     translational physiology approach (i.e., study of physiology from molecule/cell to~     population) to investigate how exercise improves cognitive performance, and the underlying~     mechanisms by which exercise prevents and/or slows down age-related declines in brain health~     and cognition. This approach allows the investigators to determine how physiological~     function is related to ADRD, with important implications for health. The investigators'~     prior work demonstrated a significant relationship between fitness, vascular regulation and~     cognition in older adults free of overt disease. These findings have implications for~     vascular cognitive impairment and ADRD, in which hypoperfusion and dysregulation of cerebral~     blood flow are thought to be important pathophysiological factors. The investigators'~     central hypothesis is that regular aerobic exercise mitigates age-related decreases in~     vascular function and cerebrovascular reserve, which in turn benefits cognition. Work by the~     investigators and others has provided the necessary data justifying a randomized controlled~     trial to evaluate the role of exercise in the prevention of ADRD.~      The investigators are well equipped to undertake this trial; the investigators have~     dedicated institutional support and necessary expertise in vascular regulation, cognition,~     aging, neuroimaging and genetics.~      The overall objective of this proposal is to test an exercise intervention for secondary~     prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD~     (with memory impairment symptoms but without dementia). The rationale for this trial is the~     urgent need for dementia prevention: an exercise intervention, which harnesses a~     translational physiology framework, holds such promise. The investigators will conduct this~     trial to determine the effects of aerobic exercise on the development of age-associated~     cognitive decline and dementia. The exercise intervention is designed with input from~     Alberta Health Services, the universal healthcare provider for Albertans, so that the~     intervention can be readily adopted into clinical practice if this trial is successful. The~     trial will address three specific aims.~      SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in~     previously inactive older adults at increased risk of ADRD. The investigators hypothesize~     that participants randomized to our six-month aerobic exercise intervention will perform~     better on cognitive tests, compared to control participants randomized to a~     stretching-toning exercise group.~      SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive~     performance after exercise training. The investigators hypothesize that exercise improves~     cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow,~     cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep~     quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk~     scores, reflective of targeted genetic variants, moderate exercise-related cognitive and~     brain outcomes.~      SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood~     flow and cerebrovascular reserve persist 12 months after participants complete a 6-month~     exercise training intervention. The investigators hypothesize that the effects of improved~     aerobic fitness will be maintained over time as a function of persistent lifestyle changes~     and behavioural support programs. This trial will provide evidence needed to make clinical~     recommendations for exercise programs in adults at risk for ADRD, with the goal of~     preventing dementia. Given the investigators' extensive stakeholder input, this intervention~     will be easily translated to other jurisdictions. This research into the mechanisms of~     effect for exercise will identify patient subgroups most likely to benefit, surrogate~     outcome markers for use in future trials to refine intervention dose/duration, and new~     therapeutic targets for future interventions.~   "
1633|NCT03035838|"~     Traumatic brain (TBI) injury is the major cause of morbidity and mortality worldwide~     especially in population under 40 years of age and has a significant socioeconomic impact.~     TBI results from the head impacting with an object or from acceleration/deceleration forces~     that produce vigorous movement of the brain within the skull, with the resultant mechanical~     forces potentially damaging neurones and blood vessels and causing irreversible, primary~     brain injury. Primary injury leads to activation of cellular and molecular responses which~     lead to disruption of the blood-brain barrier causing the brain to swell. As the~     intracranial space is not expandable (i.e. is fixed), this swelling leads to increase in~     intracranial pressure (ICP) compromising blood supply to the rest of the brain leading to~     secondary brain injury. As we are unable to reverse the primary injury, current protocols~     use supportive measures to control the ICP and ensure optimal blood supply to the brain in~     an attempt to minimize secondary injury. Our understanding of the factors involved in the~     initiation and propagation of brain swelling in TBI is growing and the role of~     neuroinflammatory cytokines in this process is increasingly recognized. In preclinical~     models of TBI, a specific inflammatory cytokine termed substance P (SP) is found to be~     associated with blood-brain barrier disruption and development of brain oedema in the~     immediate phase following injury. The aim of this study is to examine the role of SP in the~     genesis of cerebral oedema and elevation of ICP and thus secondary injury following human~     TBI. This would be achieved by blocking SP function with a SP receptor antagonist~     Fosaprepitant (IVEMEND®, Merck) in the first 24 hours following TBI and then continuously~     measuring ICP and assessing the evolvement of TBI using magnetic resonance imaging.~   "
1634|NCT03035825|"~     This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in~     head and neck cancer patients with xerostomia.~   "
1635|NCT03035812|"~     Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could~     be useful. This therapeutic intervention has been said to increase extracellular volume~     leading to rising blood pressure. No prospective data has been published in clinical~     routine. Here, investigators propose to follow patients in which an oral alkalinization is~     indicated: blood pressure, body weight, and a clinical evaluation of the extracellular~     compartment will be performed at the beginning and during the follow-up of participants. The~     principal criterion of evaluation will be the variation in the extracellular compartment.~   "
1636|NCT03035799|"~     This pilot study proposes to gain a better understanding of the health benefits of the~     popular paleo-diet in patients with irritable bowel syndrome (IBS) and explore underlying~     mechanisms of benefit.~   "
1637|NCT03035786|"~     This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic~     help to manage acute airway crises in the hospital (out of theatre, out of Surgical~     Intensive Care Unit, SICU).~      The anaesthetists are doctors trained in advance airway management. Patients in the hospital~     may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion~     of breathing tube) for various reasons. The on call SICU anaesthetists responds to the~     airway code by attending the patient in need and managing the patient at their own~     discretion.~      Airway management will depend on the anaesthetist's knowledge, skills and experience. it~     will also depend on the available airway equipment.~      We plan to evaluate airway codes for a 24 month period. Parameters include: type of~     incident; patient factors (including airway assessment); type of equipment used; anaesthetic~     drugs used; airway management chosen by the attending anaesthetist; and, airway~     complications.~   "
1638|NCT03035773|"~     OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered,~     effective in promoting appropriate survivorship care and can be successfully implemented for~     patients with different types of cancer who are being treated in a broad range of clinical~     settings. There is a need for research related to SCP that prioritizes outcomes that are~     most highly valued by patients, caregivers and clinical stakeholders.~   "
1639|NCT03035760|"~     This Phase I study is an open label multiple ascending dose evaluation of the safety and PK~     of oxfendazole given orally daily to healthy adult men and nonpregnant women aged 18-45~     followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a~     single dose of oxfendazole given following an 8 hour fast or following a high fat meal. The~     study duration will be approximately 12 months with each subject participation lasting~     approximately 6 weeks. In the first phase of this study, between 8 and 24 subjects will be~     enrolled; each dose group will be comprised of 8 volunteers. To enhance safety, one sentinel~     subject will be dosed for five days and monitored for 7 days from the time of the first dose~     for predefined adverse events. If there are no predefined safety events, a second sentinel~     subject will be enrolled and followed for a total of 7 days. If there are no predefined~     safety signals identified for either of these two sentinel subjects, the remaining subjects~     in the group will be enrolled. After all eight subjects have completed the 10 day follow up~     period, a safety review of the electronic data will be performed. If none of the predefined~     safety events have occurred DMID will approve enrollment into the second dose group and will~     be monitored for a total of 7 days each for predefined adverse events prior to enrolling the~     remaining subjects in the group. After the 10 day follow up period has been completed for~     group 2, a safety review will be completed and if no predefined events have occurred two~     sequential subjects will be enrolled into the third dose group and will be monitored for a~     total of 7 days each for predefined safety events prior to enrolling the remaining subjects~     in the group. In the second phase of the study evaluating the effects of food on drug~     absorption, 12 subjects will be enrolled into the single dose cross over study where half of~     the subjects will initially receive a single dose of oxfendazole following an 8 hour fast~     and the other half will receive a single dose of oxfendazole following a high fat meal.~     Subjects will then cross over to receive a single dose following a high fat breakfast or~     fasting period. All subjects will have received a dose of oxfendazole following both a~     fasting period and a meal. The primary objectives are: 1) To assess the safety of~     oxfendazole administered daily for five days; and 2) To assess the safety of oxfendazole~     administered as a single dose with or without food.~   "
1685|NCT03035136|"~     Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.~   "
1647|NCT03035656|"~     The following is a double blinded, randomized controlled clinical trial to test the~     hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single~     intra-operative epidural injection of Ropivaciane® will result in decreased postoperative~     pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2)~     Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if~     there are differences in pain management between MIS and open surgical procedures. The~     proposed study will add novel information to current knowledge by 1) exploring of the~     effects of intra-operative single epidural injection analgesic on patients receiving MIS~     compared to open surgery, and 2) investigate potential immediate and short-term functional~     improvements gained from intra-operative single injection of Ropivaciane®.~   "
1648|NCT03035643|"~     This study is for participants who have been diagnosed with an acute aortic~     dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/~     intramural hematoma). In a healthy aorta (the vessel that supplies blood to most of the~     body) the blood flows freely through the main lumen (a space inside the vessel where blood~     flows). The participants involved in this study have a tear that has separated the inner~     layer of the aorta wall and created a secondary channel (false lumen) in addition to the~     main channel (true lumen). The blood is now flowing through both channels.~      The purpose of this study is to investigate the feasibility and safety of the AMDS (stent).~     The use of this device may allow healing of the false lumen (separated channel). If the AMDS~     together with conventional surgery is effective, it is believed that this could lead to the~     repair of the dissection (tear) in the treated aorta,~   "
1649|NCT03035630|"~     This is an open label, randomized phase II trial. Eligible subjects will be randomized in a~     1:1 ratio and stratified for known prognostics variables to one of two first-line medication~     treatment arms. Once disease progression has been documented, and following a required~     inter-line washout period, subjects will receive either second-line medication treatment or~     discontinue treatment, per discretion of treating investigator.~   "
1650|NCT03035617|"~     Early post-operative pain and discomfort after laparoscopic repair remains a concern for~     patients requiring hospital stay and parenteral narcotic analgesics . This quite often~     proves to be a hindrance in early ambulation, enhances patient discomfort and prevents early~     discharge from hospital.~      Local anesthetics infiltration at wound site after various procedures is known to be~     effective in reducing immediate post-operative pain , . In case of laparoscopic ventral~     hernia repair, delivering local anesthetic at site of mesh application can be achieved by~     soaking the mesh in local anesthetic solution before application. To date there is no~     evidence regarding impact of soaking mesh in bupivacaine solution before application in case~     of laparoscopic ventral hernia repair.~      OBJECTIVE:~      Primary Objective:~      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal~     saline solution on post-operative pain after laparoscopic ventral hernia repair.~      Secondary Objective:~      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline~     solution on length of hospital stay after laparoscopic ventral hernia repair.~      Study Sample:~      Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery~     clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility~     criteria of inclusion into trial.~      SETTINGS:~      Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi.~      Patients will be evaluated in clinic at the time of presentation regarding eligibility to~     participate in study. Written informed consent will be taken in clinic. A copy of the~     consent form will be handed over to the patient. Clinical Trial Unit will be informed of the~     scheduled date and time of the operation. Allocation will be done by the staff at clinical~     trial unit which will be kept undisclosed to the investigators, patients and outcome~     assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form~     according to treatment arm allocation. After the operation first assessment of pain will be~     done six hours post-operatively using VAS. Second assessment will be done at twenty four~     hours from end of operation. This assessment will be done directly if patient is admitted in~     the hospital or will be done on telephone if patient is discharged home.~      FOLLOW UP:~      Pain assessment will be done using visual analogue scale (VAS). This is validated score to~     measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten~     means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.~   "
1651|NCT03035604|"~     The goal of this research study is to learn about ways to check for malnutrition (loss of~     weight/appetite that may result in health problems) that is due to cancer or cancer~     treatment.~   "
1652|NCT03035591|"~     This is a first-in-man study to assess the safety and tolerability and to characterise the~     pharmacokinetics of ODM-207.~   "
1653|NCT03035578|"~     This research aims to study what the baby's body does with morphine and how morphine works~     in the baby's body. One hundred newborn babies will be enrolled in this study. With a better~     understanding of the drug doctors and nurses will have more information and better~     administer the drug in case of pain, stress or discomfort.~   "
1654|NCT03035565|"~     Cognitive Intervention to Improve Memory in Heart Failure patients~   "
1655|NCT03035552|"~     The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)~     using contingent positive reinforcement with mother's voice can improve the feeding outcomes~     of infants with congenital heart defect (CHD) at high risk for oral motor problems.~   "
1656|NCT03035539|"~     The purpose of this study is to investigate whether a rehabilitation programme can improve~     the quality of life and reduce morbidity in patients with atrial fibrillation.~      In addition, the study will map the economic costs and benefits of such a rehabilitation~     programme.~   "
1657|NCT03035526|"~     In this study, our aim is to show the relation between sex hormones and PAT and to confirm~     whether PAT is associated with coronary artery calcification (CAC) in different testosterone~     levels in the males.~   "
1658|NCT03035513|"~     Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic~     encephalopathy. Even if the correlation between the severity of the epilepsy and the~     cognitive consequences is well established, the mechanisms involved in epileptic cognitive~     degradation are complex and poorly understood. In CSWS, there are many arguments for the~     implication of cortical and subcortical cerebral structures. Among them the thalamus seems~     to play a crucial role. In fact it is strongly implicated in the sleep and this function is~     determining for learning. Moreover, it is part of the propagation pathway of generalized~     forms of epilepsy like absences in animal studies. Unfortunately there is no animal model~     for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries~     but most of the time conventional MRI is normal. Despite few literature on CSWS, some~     studies reported abnormal functional connectivity especially in the thalamus.~      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)~     and tractography will be useful in CSWS to confirm the implication of a~     cortico-thalamo-cortical network showing an abnormal structural connectivity. The~     investigators will try to determinate if a particular thalamic nucleus is concerned and~     demonstrate a link between the disease severity (duration and cognitive consequences) and~     the importance of structural abnormalities.~      Using resting state functional MRI (fMRI), the investigators will also try to investigate~     the default mode network. Its implication was also suggested in the literature.~   "
1660|NCT03035487|"~     The investigational protocol describes a small case series designed to compare three imaging~     modalities for use in visualizing prostate cancer.~      The three modalities to be tested are: transrectal micro-ultrasound , and conventional~     resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the~     multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI~     (mpMRI).~      These modalities will be used for guiding systematic (standard, random, extended sextant)~     plus image-guided targeted prostate biopsies among men with known cancer and an indication~     for prostate biopsy.~      In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the~     radiology report used for targeting.~   "
1661|NCT03035474|"~     CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the~     effect of 2 quality improvement (QI) initiatives compared with usual care on heart failure~     (HF) outcomes and HF quality of care metrics at 1 year after discharge for participants~     hospitalized with acute HF and reduced ejection fraction (EF). The interventions will~     include both a health-system engagement group (direct) and a participants engagement group~     (digital).~   "
1662|NCT03035461|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly~     population of the industrialized world. AMD is a progressive degenerative disease affecting~     the central area of the retina, responsible for distinct vision. Vision loss arises from~     aberrant new vessel growth which causes the accumulation of blood or fluid within the~     retina's thickness and eventually leads to permanent scarring. The two major forms of AMD~     are exudative, or neovascular or wet, and non-exudative, or dry.~      Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic~     process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat~     wet-AMD.~      After diagnosis and explanations of the practionner, the patients and their close relatives~     have still frequently many questions about the treatment, the intravitreal injections, the~     prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of~     diagnosis announcement and the understanding of the patients on the disease course.~      The aim of this study is to evaluate the feelings and the understanding of the patients~     after the diangosis of AMD as well as the understanding of the patient care.~   "
1663|NCT03035448|"~     The goal of this research study is to learn about advanced cancer patients' preferences~     about how psychology services are introduced.~   "
1664|NCT03035435|"~     In the last years, a lot of surgical fast track programs (SFTP) have been created and~     developed. This is due to the steady growing number of interventions on knee and hip; after~     the surgical treatment, a period of physical rehabilitation (PR) is established to be useful~     and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM),~     independence, the reduction of pain and disability are the aims of PR. With the SFTP and a~     specific rehabilitation program named fast track rehabilitation (FTR) these times can be~     reduced. First of all because the length of stay (LOS) it's also caused by organizational~     problems of the hospitals, not only for the factors related to the patient. It's already~     been demonstrated that an early mobilization decreases the risk of thromboembolic~     complications and of pain, furthermore an early rehabilitation increase the patient autonomy~     and reduces the lost of residual abilities. Moreover a PR program studied for fast track~     patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts~     that are always a problem for all the countries. The aim of this study is therefore to~     propose a fast track rehabilitation program based on an 8 days program for hip and knee~     arthroplasty being operated with an SFTP.~   "
1665|NCT03035422|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option~     with a significant chance of healing in acute myeloid leukemia (AML) or refractory multiple~     relapses after chemotherapy. However, all patients with an indication of allo-HSC can not~     benefit because of two limitations: the toxicity of the treatment and graft shortage~     available.~   "
1666|NCT03035409|"~     The goal of this clinical research study is to learn if anamorelin can help to decrease~     cancer-related fatigue in patients with advanced cancer.~      The safety of this drug in combination with physical activity will also be studied.~   "
1667|NCT03035383|"~     Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of~     wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed~     purse-string suture for the first time for the closure of skin defect after thyroidectomy of~     large thyroid tumors which resulted in better cosmetics as compared to the conventional~     suturing method.~   "
1668|NCT03035370|"~     The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and~     immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the~     cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or~     50 mcg PT protein compared to Viaskin placebo.~      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be~     assessed throughout the 10-week study and its immunogenicity will be assessed at regular~     intervals with collection of blood samples for immunological analyses.~      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will~     receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the~     optimal recall of their immunity against pertussis.~   "
1669|NCT03035357|"~     The goal of this clinical research study is to learn about biomarker changes in patients who~     have primary prostate cancer after receiving Darzalex (daratumumab) and then have a~     prostatectomy (the surgical removal of the prostate) as part of their standard care.~     Biomarkers are found in the blood/tissue and may be related to your reaction to the study~     drug.~   "
1670|NCT03035344|"~     Study of the intermediate metabolism in children diagnosed with ALL compared to healthy~     matched controls.~   "
1671|NCT03035331|"~     This phase I/II trial studies the best dose and side effects of dendritic cell therapy,~     cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such~     as dendritic cell therapy made from a person's tumor cells and white blood cells may help~     the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer~     cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the~     ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and~     pembrolizumab may work better at treating non-Hodgkin lymphoma.~   "
12273|NCT02896543|"~     This study evaluates the relationship of change of dendritic cells fractalkine and~     P-selectin in patients with acute myocardial infarction.~   "
1672|NCT03035305|"~     SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August~     and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.~      The objective of this study is to determine whether the association SMC and LNS reduces the~     number of confirmed malaria cases among children 6-59 months during the monthly SMC~     distribution sessions.~   "
1673|NCT03035292|"~     Sensitivity and specificity of current screening methods for congenital cataracts in~     neonates is poor. This results in delayed diagnosis and management which can decrease the~     visual prognosis following cataract surgery. It also results in many false positives with~     resultant unnecessary healthcare costs in specialist paediatric ophthalmology services. The~     investigator has developed a new digital technique to improve the accuracy of screening for~     congenital cataract and this study will compare this new test with the current test~     performed.~   "
1674|NCT03035279|"~     This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer~     (CRC), and consists of Part A (dose regimen finding), followed by Part B (dose expansion).~     Part A (dose regimen finding) will involve dose escalation and possible dose interval~     modification to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose~     (RP2D) and schedule. Part B (dose expansion) will enroll additional participants who will be~     treated with a study drug dose at or below the MTD determined in Part A.~   "
1675|NCT03035266|"~     The investigators will compare differences in quadriceps strength, leg girth, and functional~     outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months~     following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight~     bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One~     group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by~     the standard protocol progression for the remainder of the treatment program. The other~     group will receive standard post-operative rehabilitation without BFR for the duration of~     treatment program.~   "
1676|NCT03035253|"~     The purpose of this study is to test the safety and efficacy of an experimental drug,~     OMP-305B83, when given in combination with FOLFIRI. OMP-305B83 is a humanized bispecific~     monoclonal antibody and was developed to target cancer stem cells. Based on preclinical~     studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may~     also impair the productive growth of new blood vessels, which tumors need to grow and~     spread.~      The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the~     Sponsor.~   "
1677|NCT03035240|"~     The purpose of this prospective, randomized, controlled three-year study is to compare the~     effect of a year-long financial education program versus usual care on health outcomes in~     single mother low income households.~   "
1678|NCT03035227|"~     The purpose of this study is to test if catheter ablation is better than medication therapy~     at treating arrhythmias originating from the upper and/or lower chambers of the heart in~     order to allow the heart to beat properly.~   "
1679|NCT03035214|"~     Most preterm babies require supplemental oxygen for a variable period of time, up to several~     weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply~     to the tissues without causing oxygen toxicity and oxidative stress. The current routine~     monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying~     pathology, as lung parenchyma and pulmonary vascular disease can be contributed in~     pathophysiology at variable degrees.~      Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have~     adverse neurodevelopmental outcome. Available data are conflicting and inconclusive;~     clinicians must use their own clinical judgment to balance the adverse effects of~     Bronchopulmonary dysplasia with the potential adverse effects of treatments for each~     individual patient. Very low birth weight infants who remain on mechanical ventilation after~     1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.~      When considering corticosteroid therapy for such an infant, clinicians might conclude that~     the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia~     are warranted.~   "
1680|NCT03035201|"~     The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized~     clinical trial of cocoa extract supplement (containing a total of 600 mg/d flavanols,~     including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the~     risk of cardiovascular disease and cancer among men aged 60 years and older and women aged~     65 years and older. This ancillary study is being conducted among participants in COSMOS and~     will examine whether the cocoa extract supplement or the multivitamin supplement improves~     cognitive function and reduces risk of cognitive impairment, including AD and other forms of~     dementia.~   "
1681|NCT03035188|"~     In this study patients with resectable basal cell carcinoma (BCC) who usually undergo~     surgery without prior anticancer treatment will be treated with antitumor medication. But~     since BCC is mainly localized in clearly visible regions of the body, as e.g. the face,~     there is also a need to reduce scars as a consequence of surgery which will be accomplished~     by neoadjuvant therapy.~      The used medication - vismodegib - displays controllable adverse events and shows a good~     efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead~     to minor surgical intervention thus minimising surgical risks and scars for the patients.~   "
1682|NCT03035175|"~     This study examines the effectiveness of utilizing video laryngoscopy to give real-time~     guidance during neonatal intubations to improve residents' success at performing~     intubations.~   "
1683|NCT03035162|"~     The aim of the present study is to evaluate the possible effect of using dual-tDCS combined~     with conventional physical therapy on lower limb function in stroke patients.~   "
1684|NCT03035149|"~     Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the~     effects of weight loss on dyspnea are not completely understood. The objectives of this~     study were to examine the relationships between exercise parameters and dyspnea in obesity~     and assess the effects of weight loss.~      The investigators compared pulmonary function, exercise performance and dyspnea in 34~     patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched~     controls. The study also assessed within-group changes in physiology and symptoms in a~     subset of patients following participation in a weight management program.~      Because obesity is a heterogeneous condition, with variable genetic associations,~     co-morbidities and distributions of adipose tissue, the study focused on patients with~     abdominal obesity who met diagnostic criteria for metabolic syndrome.~   "
1686|NCT03035123|"~     The EduStra-HF study will examine the impact of an intensive therapeutic education on~     patients discharged from hospital after an episode of acute heart failure (HF).~      Patients will be randomized into two groups: one will receive usual care monitoring and~     one will receive a specific educational monitoring programme for 1 year.~      All patients will meet with a specialized therapeutic education nurse before discharge.~      The effect of the intensive education on HF rehospitalization and quality of life will be~     examined.~   "
1687|NCT03035110|"~     The current research is being undertaken as part of a professional doctorate in clinical~     psychology, which aims to evaluate the feasibility of a group programme to address self-harm~     within 23 days, to provide evidence for a controlled trial. The intervention will include~     four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.~     Specifically the aims are to determine 1) means and a standard deviation for two pre and~     post treatment outcome measures in order to estimate sample size for the main study, 2) the~     need for an inpatient intervention for self-harm measured by number of participants eligible~     and accepting of the treatment, 3) retention of participants for 4 groups given the~     predicted short stays of patients on wards, and 4) the acceptability of the research process~     for this client group through feedback.~   "
1688|NCT03035097|"~     The purpose of this research study is to establish a research database and biorepository for~     patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or~     Operation Enduring Freedom (OEF). This study will also include civilian contractors who~     worked as part of these military operations in Iraq or Afghanistan. The biorepository would~     store blood samples obtained from these patients during a clinic visit. The research~     database would store prospectively and retrospectively collected clinical and exposure data~     that would enable us to comprehensively characterize each case.~   "
1689|NCT03035084|"~     Several studies have demonstrated that D2 treatment is associated with a decrease in~     25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising~     total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease~     in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being~     specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in~     25(OH)D2 level.~      The investigators plan to conduct a double-blind placebo-controlled trial to examine the~     effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve~   "
1690|NCT03035071|"~     The MIOMIE trial is a prospective randomized controlled study comparing open and~     laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to~     compare the minimally invasive approach with the standard open procedure regarding morbidity~     and mortality.~   "
1691|NCT03035058|"~     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous~     (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying~     inflammatory bowel disease (IBD).~   "
1692|NCT03035045|"~     This randomized controlled trial, compares perioperative and postoperative pain score by~     using visual analog scale in pregnant women undergoing amniocentesis. The experimental group~     will be given oral paracetamol premedication whereas the controlled group will be given oral~     placebo premedication.~   "
1693|NCT03035032|"~     The objective of this study is to evaluate the safety, efficacy, and impact on quality of~     life (QoL) of ELIGARD® in hormone-dependent prostate cancer patients in Asia.~   "
1694|NCT03035019|"~     Stress and anxiety can worsen quality of life in patients seen in primary care practices.~     This project is set in UPMC primary care practices (CMI) to evaluate how the availability of~     a virtual stress management program can help patients reduce stress and anxiety and improve~     their quality of life. The project will analyze the efficacy of the virtual stress~     management program at these practices so that it can then be utilized effectively in other~     medical settings where it can be offered as a part of clinical care to reduce stress and~     anxiety and improve the quality of life of medical patients who could benefit from a~     reduction in stress. This research is being piloted at these sites in the hopes of~     publishing results that show that it can be implemented in other practices throughout the~     country.~   "
1695|NCT03035006|"~     This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy~     in hepatocellular carcinoma with portal vein tumor thrombosis.~   "
1696|NCT03034993|"~     The purpose of this study is to determine if an automated text message intervention is~     beneficial for homeless patients in reducing their hospital visits, increasing their primary~     care appointments, and help them increase medication adherence.~   "
1697|NCT03034980|"~     Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the~     coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia~     are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass~     grafting (CABG). Following hospitalisation, the patients are offered to attend a classical~     rehabilitation program with moderate exercise intensity. Current exercise program for~     cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to~     improve the exercise capacity and risk profile even more if the exercise program includes~     more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or~     CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are~     excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are~     determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the~     aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training~     load during rehabilitation.~      The research goal is to investigate the influence of training intensity on the exercise~     capacity and risk profile of CAD patients.~   "
1735|NCT03034460|"~     Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using~     intra-individual comparison involving subjects with acne vulgaris on face to evaluate the~     efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.~   "
1829|NCT03033238|"~     The purpose of this study is to investigate opportunities for prevention and treatment of~     knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and~     poor pain and physical function outcomes especially among those with early or mild knee~     symptoms. The goal of the study is to find novel strategies to prevent disease at an early~     stage and to limit the impact of disease once it has occurred.~   "
1698|NCT03034967|"~     Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as~     a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2,~     randomized, double-blind (Sponsor Open) study. The primary objective of the study is to~     evaluate the clinical activity and safety of danirixin compared with placebo in participants~     with COPD. Following baseline assessments collected over a 7 day period participants will be~     randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram~     [mg], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally~     twice daily for 24 weeks. Participants will continue with their standard of care inhaled~     medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while~     receiving study treatment. Follow up will continue up to 28 days post last dose.~     Approximately 700 participants will be screened with a target of 540 participants completing~     24 weeks of treatment and key study assessments.~   "
1699|NCT03034954|"~     As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study~     will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of~     electricity to modulate brain functioning, can improve cognitive abilities. Here, the~     effects of TES on working memory, learning, and memory, will be evaluated in a group of~     healthy older adults.~   "
1700|NCT03034941|"~     The aim of this study was to evaluate the impact of short-term weight reduction achieved~     with 12-week intervention with metformin alone or in combination with liraglutide on oocyte~     maturity and embryo quality in infertile obese PCOS population.~   "
1701|NCT03034915|"~     COPD is characterized by an airflow limitation, which is not fully reversible, usually~     progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a~     major cause of disability and anxiety associated with the disease. In addition, COPD is~     associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used~     to improve lung function, reduce symptoms, reduce the frequency and severity of~     exacerbations, and also to improve health status and exercise tolerance.~      This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study~     to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5~     mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD.~     The primary purpose of this study is to demonstrate improvements in lung function for~     subjects treated with UMEC/VI compared with UMEC for 24 weeks.~      Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio.~     Subjects will be stratified based on long-acting bronchodilator usage during the run-in~     period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either~     UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA®~     dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once~     daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol~     (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via~     ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening~     period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up~     period of 1 week.~      ELLIPTA and DISKUS are trademarks of GSK group of companies.~   "
1702|NCT03034889|"~     The infantile brain has to pass essential, mayor steps in the first 36 months of life.~     During that period of development it is particularly vulnerable to toxic, exogenic~     influences. This study wants to review the long-term effects of children who were exposed to~     anesthesia in the first three years of their life. Therefore the investigators will examine~     children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive~     capacity to children who did not have any exposure to anesthesia. The investigators plan on~     measuring the intelligence quotient using standardized tests which will be performed by a~     trained psychologist. In addition there will be a questionnaire concerning behavioral~     characteristics and educational development which is filled by the parents. The exposed~     children will be recruited from our preexisting database, the control group will be~     recruited from practitioners and the pediatric walk-in-clinic.~   "
1703|NCT03034876|"~     Acute Kidney Injury is common in critically ill children and is associated with high~     morbidity and mortality in pediatric intensive care unit. The serum creatinine is still a~     gold standard test for diagnosis of AKI, but it rises after 1 to 3 days of injury . However,~     Neutrophil Gelatinase-Associated Lipocalcin (NGAL) is an emerging biomarker in identifying~     AKI at an early stages, which may in future help us in promptly instituting reno-protective~     interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of~     euvolemia and perfusion pressure which will not only preventing kidney from further failing,~     decrease the use of very expensive and complicated renal supportive therapy like continuous~     renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to~     AKI.~   "
1704|NCT03034863|"~     The management of suicide risk is a pressing national public health issue especially among~     Veterans, and there exist no guidelines of how best to involve family members in this~     effort. This proposal will integrate family and couples communication skills training with~     suicide safety planning. The goal is for the sharing of Veteran suicide safety plans with~     family members and the construction of a parallel family member safety plan, in efforts to~     mobilize and support family involvement.~   "
1705|NCT03034850|"~     Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy~     (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological~     malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on~     platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is~     phase dependent. This study demonstrates the combined use of ROTEM (rotational~     thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test)~     assays during CRS and HIPEC with a follow-up of 7 days postoperative.~   "
1760|NCT03034135|"~     This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor~     effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their~     routine standard of care with TMZ therapy for approximately 6 months. Patients will be~     evaluated for response every 8 weeks. Patients will be followed up 2 years after the last~     dose of DSF-Cu.~   "
1761|NCT03034122|"~     The aim of the study is to establish if caffeine consumption is associated with the~     evolution of the disease in premanifest HD.~   "
1762|NCT03034109|"~     The purpose of this study is to test the effects of tDCS (Transcranial Direct Current~     Stimulation) on stroke patients with working memory problems.~   "
1706|NCT03034837|"~     Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high~     occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure~     caries in this tooth is therefore of great importance for the preservation of a healthy~     dentition in one's life long time.~      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly~     effective method to prevent pit and fissure caries. It has also been shown that the~     performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,~     classification type 2 GIC material) using finger press method used in the atraumatic~     restoration method is as significant as that of using the traditional resin sealant material~     and technique.~      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the~     two sealing materials in the prevention of pits and fissures caries in young permanent~     molars of schoolchildren in a dental public health program to be held in primary schools.~     The findings will provide valuable information for decision making on the election of proper~     material and method for use in dental public program, especially for child population in the~     rural or social-economically deprived areas.~   "
1707|NCT03034824|"~     The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and~     tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical~     periodontal parameters following the treatment with~     Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to~     scalling and root planning (SRP) in patients with generalized aggressive periodontitis~     (GAgP). Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was~     designed as a split-mouth study. In each patient, three quadrants were randomly determined~     as SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were~     recorded at the baseline and third month after the treatment. Cytokines levels in GCF were~     determined by enzyme-linked immunosorbent assay (ELISA).~   "
1708|NCT03034811|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for the commercially available Persona Partial Knee System.~   "
1709|NCT03034798|"~     The purpose of the study is to determine the effects of insulin suspension at start of~     exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for~     this project. The first will be a familiarization session that requires completed informed~     consent, anthropometric measurements (height, weight, body fat percentage), questionnaires,~     and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic~     exercise as well as circuit exercise.~   "
1710|NCT03034785|"~     The morbidities associated with very low birth weight (VLBW) infants constitute a major~     health problem and a significant emotional and financial burden for families and our nation.~     The key to reducing this burden is early diagnosis. This research will be the first step~     towards intervention for cerebral growth and long-term neurodevelopmental morbidities of~     VLBW infants.~      The proposed research is to design and fabricate a new technological innovation in wearable~     soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the~     hand (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they~     plan to engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure~     planning and force modulation. Additionally, the investigators plan to have the~     parent/guardian wear the gloves so they can determine the relative contributions of the~     child and the adult to the child's learning. In the same way that the adult assists learning~     to walk, they may assist in learning during play. The force data may be analyzed in the same~     way as the child's data.~      The investigators' new flexi-mitt technology has the potential to provide a new diagnostic~     technology and the development of clinical assessment norms. With additional trials of the~     technology in large numbers of young children, it may be possible for clinicians and day~     care providers to eventually make measurements of planning and force modulation in play~     settings.~   "
1711|NCT03034772|"~     A previous pilot study demonstrated that commonly available glaucoma drops~     (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet~     age-related macular degeneration who have been receiving anti-vascular endothelial growth~     factor (VEGF) injections. This will be a larger study where subjects are randomly assigned~     to receive the glaucoma drops or a placebo (artificial tears) in order to confirm whether~     this previous finding is valid. Subjects will continue to receive the normally scheduled~     anti-VEGF injections at regular intervals as done prior to enrollment. The only addition to~     the regimen will be the daily use of eye drops (dorzolamide-timolol or artificial tears)~     twice daily for the duration of the study. At the end of the study, the swelling in the~     retina will be compared to the amount before starting the drops to see if there is any~     difference between the group using dorzolamide-timolol versus artificial tears.~   "
1712|NCT03034759|"~     We aim to test the efficacy of a new method for determining individual insulin sensitivity~     (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to~     carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D).~      To date, the individual insulin sensitivity (IS) could only be investigated by intensive and~     invasive research techniques that are not feasible to perform in an outpatient setting for~     pediatric patients with diabetes.~      Recently published studies have demonstrated the efficacy of an algorithm to calculate the~     patient specific insulin sensitivity to customize the CR for adult patients with T1D. The~     algorithm has been validated in adult patients, however not yet investigated in the~     pediatric population with T1D.~      The aims of our study are:~        1. to customize the CR of pediatric subjects with T1D using the individualized insulin~          sensitivity index (ISind) to improve post-prandial blood glucose control after a~          standard meal.~        2. to test, under free living condition (at home), the efficacy of the customized CR in~          improving post-prandial glycemic control for pediatric subjects with T1D.~      This approach would have at least two potential benefits for pediatric patients with T1D:~        1. To provide a non-invasive tool for individualizing their home insulin therapy;~        2. To offer a reliable instrument for adjusting the meal bolus of the current hybrid~          closed loop (HCL) systems to account for the inter-subject variability in insulin~          action.~   "
1763|NCT03034096|"~     This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with~     total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,~     or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.~   "
1713|NCT03034746|"~     Emerging literature suggests that vascular factors might be involved in the pathogenesis of~     Alzheimer's disease (AD). Other recent studies demonstrate the positive effects of physical~     activity on cognitive and behavioral disturbances of patients with AD. Therefore, it has~     been postulated that exercise enchantment in cerebral circulation is the physiological~     mechanism that link physical exercise and reduction of AD symptoms. Consequently, a program~     of physical activity could be considered one approach to counteract dementia by improving~     cerebrovascular health.~      However at this moment, it is not clear if the progressive brain vascular dysfunction and~     hypoperfusion, associated with the β-amyloid deposition, might be reversed or stabilized by~     an exercise intervention.~      The aim of this study is to assess, in patients with AD, the influence of physical exercise,~     compared to cognitive stimulation, on:~        -  Cognitive function;~        -  Independence in daily living and behavioral symptoms;~        -  Vascular function Finally, to investigate the physiological processes on the basis of~          the motor parameters' changes, the performances of the patients will be compared with~          the performances of healthy young and old subjects.~      MAIN OBJECTIVE: Investigate, in patients with Mild Cognitive Impairment (MCI) and AD, the~     effects of a physical activity program, or cognitive stimulation on global cognitive~     function.~      SECONDARY OBJECTIVES: Investigate the effects of the two treatments on:~        -  cognitive and motor performances,~        -  independence in activities of daily living,~        -  behavioral symptoms,~        -  peripheral vascular function.~   "
1714|NCT03034733|"~     The purpose of this study is to examine, if a single-dose of dexamethasone given during the~     operation, alleviates pain after knee replacement surgery.~   "
1715|NCT03034720|"~     SPECIFIC AIMS~      While post-concussive symptoms following sports-related concussion are typically transient~     and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who~     sustain concussion experience significant morbidity that can persist well beyond the normal~     disease course.Furthermore, post-concussive symptoms commonly co-occur with affective~     symptoms including depression and anxiety which when present can prolong recovery from~     primary post-concussive symptoms. Together, persistent physical and psychological symptoms~     confer protracted functional impairment and create a significant burden for affected youth,~     their family, and school. Currently, there are no evidence-based guidelines to inform~     treatment of persistent post-concussive symptoms in youth and adolescents.~      In response to the dearth of evidence-based treatment approaches for youth with persistent~     post-concussive symptoms, the investigators developed a novel collaborative care treatment~     model that simultaneously targets post-concussive symptoms and co-occurring depression and~     anxiety. Athletes and their family members receive patient navigator care management~     services that bridge post-injury care across acute care, specialist and primary care health~     service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who~     remain symptomatic after initial treatment efforts receive stepped-up care that may include~     psychopharmacologic consultation. The Investigators have demonstrated feasibility of the~     intervention model through a pilot randomized-control trial of 49 adolescents with~     persistent post-concussive symptoms recruited from a regional children's hospital.~     Participants assigned to the intervention condition demonstrated significant and~     clinically-meaningful reductions in post-concussive and depressive symptoms as well as~     health-related quality of life as compared to adolescents in the usual care arm of the~     trial.~      The proposed study will expand upon the pilot trial in order to further develop, implement,~     and test the impact of an innovative collaborative care approach tailored to the needs of a~     patient population who currently have no evidence-based options. The investigators propose a~     broad reach intervention strategy that is designed to be readily implemented in acute,~     specialty and primary care medical settings, as well as over the telephone. The~     investigators will conduct a randomized comparative effectiveness trial with 200 youth, ages~     11-18, suffering from ≥ 3 post-concussive symptoms at least 1 month after their~     sports-related injury. Athletes will be randomized to collaborative care (intervention) or~     post-sports injury care as usual (control group) conditions. The study is designed with the~     following aims:~      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in~     reducing post-concussive and co-occurring psychological symptoms in youth with persistent~     post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative~     care intervention will demonstrate clinically and statistically significant reductions in~     post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month~     study, compared to usual care control group athletes Aim 2. To examine the effectiveness of~     the intervention in improving function and health-related quality of life amongst youth with~     persistent symptoms after sports-related concussion H2: Adolescents who receive a~     collaborative care intervention will exhibit a clinically meaningful improvement in function~     and health-related quality life Exploratory Aim 3. To explore differences in school~     performance between groups H3: Adolescents who receive the collaborative care intervention~     will receive individualized treatment and community resource linkages which will improve~     their school performance as compared to adolescents receiving treatment as usual~      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological~     symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral~     health providers, the collaborative care health services intervention could accelerate the~     rate of recovery from persistent post-concussive symptoms and attenuate the degree and~     duration of disability during adolescence, a critical period for healthy development.~     Validation of this treatment through a scaled up clinical trial will serve as a foundation~     for broader dissemination of this collaborative care treatment model. The multidisciplinary~     sports concussion research team will simultaneously work nationally and internationally to~     ensure study results are expediently translated into effective policy for youth athletes~     suffering from enduring symptoms and functional impairments in the wake of sports-related~     concussions.~   "
1716|NCT03034707|"~     The B vitamin biotin is widely available as an over the counter supplement, often advertised~     and used to promote health of hair, skin and nails. Commercially available over the counter~     biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the~     recommended dietary allowance). The biotin molecule is also sometimes used as part of the~     lab technology to measure hormone and protein levels in the blood. It is possible that high~     doses of ingested biotin may interfere with accurate hormone or protein measurement using~     biotin related in vitro measurement systems. Such interference, if present, could lead to~     misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin~     assay systems while ingesting biotin in currently available high dose supplements. The data~     will be compared to measurements obtained prior to and one week after stopping the biotin~     supplement.~   "
1717|NCT03034694|"~     The effect of teledermatology on length of hospital admission, length of stay, 30 day~     readmission rate, and antibiotic use in patients presenting with cellulitis vs~     pseudocellulitis in an academic emergency department setting.~   "
1718|NCT03034681|"~     This pilot pre-post quasi-experimental study evaluates for the first time the~     effectiveness of Vojta Therapy in treating lumbosciatic and compares it with the~     transcutaneous electrical nerve stimulation (TENS) procedure. Patients who agree will be~     distributed alternately in order of arrival to a Physiotherapy Unit, in such a way that half~     of the sample will be treated using TENS and the other half with Vojta.~   "
1719|NCT03034668|"~     Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength,~     muscle function, and lean body mass~      Participants: The acute phase will include 30 participants, and the chronic phase will~     include 84 participants. All participants must be healthy recreationally active males~     between the ages of 18 and 35 years.~      Procedures (methods):~      Acute phase: Participants will complete three testing visits as part of as part of a~     cross-over design, during which strength and muscle function will be assessed prior to and~     following consumption of a supplement. The experimental supplement is a blend of the~     botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half~     dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).~      Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and~     metabolic panel, subjective surveys, and strength will be measured prior to and following an~     8-week supervised resistance training program, in conjunction with daily supplementation of~     FULL, HALF, or PLA.~   "
1720|NCT03034655|"~     The aim of this study is to evaluate and compare the effectiveness of vestibular~     rehabilitation developed using computerized dynamic posturography or a mobile posturographic~     system with vibrotactile stimulation, to improve the balance in older people and reduce the~     number of falls.~   "
1721|NCT03034642|"~     The long-term goals of this study are (a) to understand the biological underpinnings for the~     increased incidence of community-acquired pneumonia in patients with chronic obstructive~     pulmonary disease (COPD) who are treated with inhaled corticosteroids; and (b) to develop~     novel therapies to treated this problem using over-expression of micro-RNAs (miRNAs).~   "
1722|NCT03034629|"~     The overall goal of this proposed study is to assess the reliability of plasticity measured~     by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst~     stimulation plasticity measures and to assess the influence of an acute bout of aerobic~     exercise on TMS plasticity measures.~   "
1723|NCT03034616|"~     The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients~     undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will~     perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the~     pathologist as to the depth of cuts and proximity to blood vessels and later.~   "
1724|NCT03034603|"~     This triple-blinded randomized placebo control trial aims to investigate the safety and~     efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The~     primary outcome measure includes adverse events and health-related quality of life. The~     secondary outcome includes tumor response and functional status.~   "
1725|NCT03034590|"~     This study will translate an English case definition of poststroke fatigue and validate it~     against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale~   "
1764|NCT03034083|"~     The purpose of this study is to determine whether the healthy marriage and relationship~     education program Elevate: Taking Your Relationship to the Next Level results in improved~     couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect~     potential.~   "
1830|NCT03033225|"~     The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a~     photodynamic therapy (PDT) to evaluate response of tumor.~   "
1726|NCT03034577|"~     Trial summary: deep neuromuscular block is proposed as a technique to improve operative~     conditions for laparoscopy. Early clinical data would suggest that there may also be patient~     benefits beyond the operative period related to lower intra-abdominal pressure, and improved~     surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential~     to use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide~     moderate neuromuscular block and reverse with neostigmine. It is not possible to safely~     reverse deep neuromuscular block using neostogmine, as the majority of block must have worn~     off for neostigmine to be effective. in order to identify whether deep neuromuscular block~     improves quality of recovery after surgery, the investigators will conduct a randomised~     trial of deep versus moderate neuromuscular block, whilst minimising variance in other~     anaesthetic techniques and drugs used. the outcome measured will be the post-operative~     quality of recovery over multiple time periods using the Postoperative Quality of Recovery~     Scale (PostopQRS). 350 patients will be enrolled over 4 centres.~   "
1727|NCT03034564|"~     This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo~     for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's~     Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well~     as the impact of fatigue on daily functioning and activities, including socialization.~     Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's~     disease-specific health related quality over the last month in 8 different dimensions of~     function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8~     situations for which the subject will rate the likelihood of falling asleep. There will be a~     screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and~     telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of~     informed consent, concomitant medication review, adverse event review, pill counts, vital~     signs (including supine blood pressure), and outcome measurements. Telephone visits will~     include review of informed consent, concomitant medication review, and adverse event review.~   "
1728|NCT03034551|"~     The goal of this study is to test the efficacy of a financial incentives-based telehealth~     intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and~     increasing adherence to patient self-care - specifically by incentivizing adherence to~     prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the~     treatment arm will be given a cellular-connected scale to use at home, as well as a mobile~     app on their smartphone that tracks their adherence to daily self-weighing through the scale~     and cardiac medications via patient photo submission. The health care team will intervene if~     a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of~     $150 are offered for full adherence over 90 days. Each day where the patient does not step~     on the scale and complete a medication check-in will result in a deduction of $2 per day~     from the incentive amount to be paid out. The control group will receive the usual discharge~     instructions as prescribed by their health care team.~   "
1729|NCT03034538|"~     In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with~     Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate~     clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined~     by number of subjects able to complete the study on their originally assigned dosage.~     Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised~     of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week~     measurements. Additional analysis of the effect of Zonisamide on quality of life will be~     measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).~   "
1730|NCT03034525|"~     Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and~     mortality. The clinical presentation of APE has many faces but it is acceptable to suspect~     this disease when the patient presenting with at least one of the following: shortness of~     breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.~      The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a~     systematic process for the exclusion / confirmation of APE all patients hospitalized for a~     first investigation of syncope. In this study APE was diagnosed in about 17% of the~     patients. In 12.7% of patients with an alternative explanation for syncope APE was~     diagnosed. Interestingly, 25% of the patients had no other manifestation of pulmonary~     embolism apart from the syncope itself.~      According to the updated clinical guidelines, APE should not be routinely tested as an~     etiology for syncope and not systematically excluded. According to the new data presented by~     Prandoni et al, this means that a significant percentage of patients hospitalized for an~     investigation of syncope are discharged when they are suffering from APE (in most cases~     probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants,~     making them particularly prone to PE recurrence.~      Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE~     (venous thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.~   "
1731|NCT03034512|"~     This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed~     over time to assess clinical symptoms for the purpose of expanding knowledge of this~     disorder in the medical community.~   "
1732|NCT03034499|"~     A prospective randomized controlled study intended to compare the efficacy of 2 methods of~     robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:~        1. Via single-port.~        2. Via multi-port.~   "
1733|NCT03034486|"~     This study is a single sequence, 3-period, multiple-dose study to evaluate the~     pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of~     D930 in healthy male volunteers.~   "
1734|NCT03034473|"~     The objective of the TransValid-KFO179/GRCSG-Trial-A is the validation of potential~     biomarkers. These are predictive (Prediction of probability of response to a certain~     therapy) / prognostic (predicting long-term outcome) microarray-based gene expression~     signatures and immunohistochemically evaluated biomarkers. The evaluation was done within~     the KFO179 (www.kfo179.de) - the validation is implemented in this trial.~      Therefore tumor material of patients undergoing standard radiochemotherapy will be analyzed~     from pretreatment biopsies an residual tissue from the resection specimen after surgery.~     This validation and the biomaterial asservation will be incorporated into clinical routine~     in all participating centers as a model for the treatment of solid tumors. The obtained~     biomarkers with a predictive and prognostic power will be used to develop an algorithm to~     predict patients at high risk of local and distant cancer recurrence.~   "
1736|NCT03034447|"~     Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who~     suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma~     more difficult to control.~      As girls usually have a more severe asthma than boys, the investigators believe that girls~     have a higher risk of sleep apnea.~      To test if asthmatic girls have more sleep apnea than boys, the investigators are going to~     ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators~     are going test the lung function and how many times they stop breathing during the sleep.~     The sleep test is going to be performed in children's home.~      In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when~     they have an asthma attack. We also are going to look if sleep apnea increases the number of~     hospitalizations and asthma attacks in the past 12 months.~   "
1737|NCT03034434|"~     Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine~     the process of cervical recuperation post delivery.~   "
1738|NCT03034421|"~     Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low~     interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment~     approach, it is associated with complications the most common of which is pneumothorax with~     a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours~     after valve implantation may reduce the risk of post-interventional pneumothorax.~   "
1739|NCT03034408|"~     Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for~     alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this~     indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on~     impulsivity.~      Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as~     measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control~     subjects.~      Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk~     taking (as measured by the Balloon Analogue Risk Task) and on the preference for small~     immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To~     compare subjects with alcohol use disorder and healthy control subjects on these tasks.~      Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary~     study outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps~     delivered in the Balloon Analogue Risk Task~      Study Design: Randomized, placebo control, cross-over, single-dose~   "
1740|NCT03034395|"~     This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who~     are candidates for surgical resection. The primary objective is to determine the feasibility~     of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm~     versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant~     melanoma after surgical treatment with 1cm versus 2cm margins.~   "
1741|NCT03034382|"~     the aim of this study is to evaluate the duration of analgesia when either morphine or~     nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block~     for arthroscopic rotator cuff repair.~   "
1742|NCT03034369|"~     The goal of this study is to identify outcomes associated with Behavioral Health Integration~     (BHI) that matter to patients, to compare changes in outcome over time to measure the impact~     of different BHI models on different patients, and to create and maintain an Integration~     Learning Collaborative.~   "
1743|NCT03034356|"~     This study plans to learn more about the effects of levetiracetam (LEV) on brain activity~     and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an~     anti-seizure drug, also called an anticonvulsant.~   "
1744|NCT03034343|"~     The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks)~     psychological intervention for the treatment of depression in Primary Care between different~     groups: a mindfulness intervention applied face to face in group format, a control group~     that will receive treatment as usual (TAU) consisting of medical treatment and the same~     mindfulness intervention applied by Information and Communication Technologies (ICTs). The~     principal hypothesis is that face to face intervention will be more effective than TAU~   "
1745|NCT03034330|"~     This study intends to develop a family-based care management intervention with primary aims~     to provide time-limited support for family caregivers affected by stroke and to empower~     caregivers through enhancing the family adaptation and functioning and increasing their~     capacity of stroke care. The objectives include:~        1. To examine the effectiveness of the proposed family-based intervention to improve~          family, caregiver, and service outcome.~        2. To examine the cost-effectiveness of the proposed family intervention.~      It is hypothesized that comparing to the control group, the experimental group participants~     will have more and significant outcome.~   "
1746|NCT03034317|"~     The purpose of this research study is to collect more information about the use, safety, and~     effectiveness of the NeuRx DPS® in ALS patients.~   "
1747|NCT03034304|"~     The purpose of this study is to determine whether the MASCT-I alone and in combination with~     chemotherapy drug are safe and effective in the treatment of advanced bladder cancer and~     soft tissue sarcoma~   "
1765|NCT03034070|"~     This study will assess and compare the diagnostic performances and image quality of two WB~     3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate~     cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main~     feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE~     sequence, reducing the exam's acquisition time, patient discomfort and increasing machine~     availability.~   "
1766|NCT03034057|"~     A one-year evaluation of Sayana Press self injection in women of reproductive age in the~     United Kingdom (UK).~   "
1788|NCT03033771|"~     Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It~     is designed to evaluate safety and performance of the MFM for the treatment of chronic type~     B aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened~     per the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed~     patients. For early demonstration of safety and performance, an interim analysis report will~     be performed after all patients included will complete their 6-month follow-up.~      The study purpose is to determine the safety and performance of the MFM for the endovascular~     treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark~     approval for aortic and peripheral artery aneurysms treatment.~   "
1748|NCT03034291|"~     Metabolic syndrome (MS) is a clinical entity that includes several disorders that predispose~     to imbalance in lipid metabolism: hypertension, insulin resistance, hypertriglyceridemia,~     obesity and low levels of high density lipoprotein. The SM itself has a great impact on~     morbidity and mortality and is also related to increased cerebrovascular risk and Diabetes~     Mellitus 2 (DM2). In Colombia, DM2 is one of the 10 leading causes of illness and death in~     people over 45 years. It is accepted that insulin resistance is a stage that precedes the~     onset of DM2, but there are few alternatives to reverse it or prevent its progression to~     diabetes.~      The control of insulin resistance requires increased physical activity, reduced body weight~     and changes in eating patterns, measures that are not easily adopted in modern Western~     society.~      There is evidence of the effect of chocolate consumption on increasing insulin sensitivity~     in both hypertensive diabetic patients as well as in normal individuals, apparently because~     of the ability of cocoa polyphenols to increase the bioavailability of nitric oxide,~     Formation of reactive species of oxine, optimizing carbohydrate metabolism and modulating~     insulin-related cellular signaling events.~      A prospective, double-blind, placebo-controlled, double-blind clinical trial evaluating the~     effect of 50 g of chocolate with 70% cocoa solids, which contributes at least 430 mg of~     polyphenols, is conducted for 8 weeks in The reduction of insulin resistance defined by the~     reduction of the HOMA-IR index. In addition, there was an increase in arterial reactivity in~     non-diabetic individuals with central obesity and insulin resistance. Likewise, to infer the~     effect of this food intervention in the modification of the total cardiometabolic risk of~     the participants.~   "
1749|NCT03034278|"~     The primary objective of this study is to better understand post-discharge utilization of~     prescribed opioid analgesic medications following surgery. A secondary objective of this~     study is to gain a better understanding of prevailing modes of storage for opioid~     medications.~   "
1750|NCT03034265|"~     The purpose of this study is to determine the concentration and interindividual variability~     of urinary exosomal sodium channels and of plasma angiotensins in patients with~     difficult-to-treat arterial hypertension and to investigate their dependency on clinical~     sampling conditions and other related laboratory parameters.~   "
1751|NCT03034252|"~     Retrospective Evaluation of Survival after Liposarcoma~   "
1752|NCT03034239|"~     Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks~     of resistance training.~      Hypothesis: Insect protein supplementation enhances the effect of resistance training on~     muscle mass and muscle strength.~      Primary outcome: Muscle hypertrophy and muscle strength~      Design: Two groups of healthy young men (age: 18-30 years) with resistance training~     experience, but no structural resistance training performed for the last 12 months.~     Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric~     carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week)~     aiming to induce muscle hypertrophy.~   "
1753|NCT03034226|"~     This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in~     healthy control subjects with and without antecedent hypoglycemia~   "
1754|NCT03034213|"~     The hypothesis for this study is complex incisional hernia repair using the separation of~     components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will~     lead to fewer incisional hernia recurrences and fewer wound complications compared to the~     same incisional hernia repair techniques reinforced with other prosthetic or~     biologically-derived mesh.~   "
1755|NCT03034200|"~     The purpose of this study is to learn if a new drug, ONC201 can make tumors become smaller~     or go away completely. Investigators also want to learn if ONC201 can prevent new deposits~     of cancer from appearing in new places in participants (metastases). A phase 2 study of~     ONC201 in PC-PG (pheochromocytoma-paraganglioma) and other neuroendocrine tumors will~     determine whether inhibition of DRD2 (a member of the dopamine receptor family) is safe in~     neuroendocrine cancers including PC-PG.~      ONC201 is an investigational (experimental) agent and has a favorable safety profile in~     phase 1 and early phase 2 clinical trials in advanced cancers. This study design has been~     chosen to see whether ONC201 is associated with reduction of anti-hypertension medications,~     safety and significant efficacy against neuroendocrine tumors, especially PC-PG.~   "
1756|NCT03034187|"~     The goal is to gain insight in the development and course of the toxicity after a curative~     treatment of prostate cancer~   "
1757|NCT03034174|"~     The objective of this study is to describe the pharmacokinetics of tigecycline in critically~     ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the~     frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy~     (200 mg loading dose and 100 mg/12h).~   "
1758|NCT03034161|"~     40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in~     this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be~     included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages~     of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal~     distribution can be identified which can then be applied to identify patients at risk of~     developing pressure ulcers at an earlier stage in their hospital course.~   "
1759|NCT03034148|"~     In human purified platelets, only thrombin, and not the other platelet agonists, leads to a~     transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of~     its bona fide substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an~     interesting marker of thrombin action on platelets. Indeed platelet and coagulation~     interplay, though undoubtedly present in atherosclerosis and atherothrombosis, remains~     difficult to assess. Our group showed that atherosclerotic mice (SRBI/Apolipoprotein E~     knock-out) had higher platelet P-ACC compared to corresponding control mice (C57BL6). In~     agreement with these data, preliminary results showed increased platelet P-ACC in a small~     cohort of patients admitted for coronary angiogram, with demonstrated coronary artery~     disease (CAD).~      In the light of our preliminary results, we sought to analyze platelet P-ACC in a large~     prospective clinical trial (ACCTHEROMA) in patients admitted for coronary angiogram. The aim~     of the study is to compare platelet P-ACC in platelets of patients with CAD and more~     particularly in unstable CAD patients to non-CAD patients. This study could potentially~     identify patients at high risk of future ischemic cardiovascular events, because of a higher~     level of thrombin generation.~   "
1767|NCT03034044|"~     This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe~     in the setting of routine practice. The primary objective is to detect medically significant~     events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy~     and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In~     this open-label, non-comparative, observational, non-interventional, retrospective and~     multi-center study, post-marketing surveillance data will be collected retrospectively for~     up to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe~     injected into patients who have been administered the Xyntha Solofuse prefilled syringe.~      As specified in the product approval issued by the Ministry of Food and Drug Safety, the~     study will be conducted for 4 years from the approval date. At least 600 study subjects will~     be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number~     of study subjects, the number of cases will be adjusted considering the actual number of~     enrolled subjects after the study start day.~   "
1768|NCT03034031|"~     This project will combine the data collected from structural and functional MRI scans and~     neuropsychology performance post-TBI in children. Patients will be followed for a year, in~     order to examine the brain and cognitive recovery post head injury.~   "
1769|NCT03034018|"~     The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-~     and postmenopausal women who are experiencing sleep difficulties related to nighttime hot~     flashes.~   "
1770|NCT03034005|"~     This study aims to assess the effect of inhaled corticosteroids (ICS) on airway smooth~     muscle (ASM) Na+, K+ pumps in patients with asthma.We wish to investigate differences in~     Na+, K+ pump content in healthy versus asthmatic patients, whether a reduction in airway~     hyper-responsiveness observed in asthmatic patients treated with ICS is attributable to an~     increase in Na+, K+ pump content in ASM cells and compare this in patients with~     non-eosinophilic asthma versus eosinophilic asthma.~   "
1771|NCT03033992|"~     This feasibility trial studies how well the Optune device works in treating younger patients~     with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. The~     TTFields generated by Optune device may inhibit the growth of tumor.~   "
1772|NCT03033979|"~     The investigators conclude that use of the LMA ProSealTM for prolonged procedures is~     feasible. In principle, it should be safer and more effective than the LMA ClassicTM~     provided basic guidelines are followed.~   "
1773|NCT03033966|"~     Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes~     following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage~     literature. How the brain injury affects cerebral oxygenation in patients with CVT is not~     currently known. Some of the factors that can affect cerebral oxygenation in patients with~     CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in~     Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how~     these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the~     cerebral oxygenation.~   "
1774|NCT03033953|"~     The aim of this study is to investigate the long term adaptations to 11 (elderly) or 12~     (young) weeks of strength training when supplemented with native whey or milk. The~     investigators hypothesize that native whey will give greater increases in muscle hypertrophy~     and strength than milk.~   "
1775|NCT03033940|"~     The primary objective is to quantify and compare the three-dimensional kinematics of the~     cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma~     Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily~     activities.~      The secondary objective is to describe the kinematics in terms of range of motion, patterns~     of anterior-posterior motion of the nearest medial and lateral points (posterior femoral~     rollback) and tibio-femoral internal/external rotation as well as the kinetics during daily~     activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto~     a chair, standing up from a chair and stair descent by means of video-fluoroscopy.~      Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and~     to the Center for Orthopaedic Engineering of the University of Denver, where it will be used~     within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and~     changes in the musculoskeletal system due to the TKA.~   "
1776|NCT03033927|"~     The purpose of this phase II study is to develop a test to predict response of pancreatic~     cancer to different chemotherapy regimens.~   "
1777|NCT03033914|"~     The aim of this study is to improve the chance of cure for people with higher risk Hodgkin~     lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study~     drug called Nivolumab when combined with ABVD for the front-line treatment of HL.~   "
1778|NCT03033901|"~     Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury~     and affect recovery and negatively influence participation in rehabilitation. Sleep apnea is~     a breathing problem while persons sleep and causes further brain damage and problems with~     thinking, daily functioning, and overall health. Earlier diagnosis and treatment is~     important for TBI survivors to maximize the recovery process. There is little information~     that guides TBI doctors on how to identify sleep apnea during inpatient TBI rehabilitation,~     a phase in which people experience the potential for a rapid pace of improvement. The Agency~     for Healthcare Research has highlighted gaps in best methods for identifying sleep apnea and~     separately in helping consumers with TBI rehabilitation choices. Partnering with survivors,~     caregivers, and administrators, investigators developed this study to compare sleep apnea~     screening and diagnostic tools in TBI rehabilitation settings. This information will provide~     clinicians, providers, and patients with the best information for early identification of~     sleep apnea to remove negative influence on the pace of recovery in early phases after TBI.~      The Goal: Investigators will compare existing screening (Aim 1) and diagnostic tools (Aim 2)~     in TBI patients undergoing inpatient rehabilitation. For the second aim, investigators will~     determine if a more accessible diagnostic test is sufficient to diagnose sleep apnea~     compared to the traditional method used which is less accessible to consumers. If the more~     accessible test is good enough, this will increase recognition of this problem and increase~     patient access to earlier sleep apnea treatment.~      Stakeholders and Products. TBI survivors, caregivers, researchers, and policymakers working~     together on this study helped develop the study questions. Idea exchanges included ways to~     reach clinicians and TBI survivors/caregivers via existing educational programming and~     online tools for consumers such as fact sheets and patient/caregiver-focused videos. Other~     traditional methods will include targeting professional magazines, conferences, and research~     journals that reach professionals working with TBI survivors and their families at the time~     of admission to rehabilitation and during the recovery process. This study will occur at~     rehabilitation hospitals around the country who enroll TBI survivors into a lifetime study~     called the TBI Model System funded by the Dept. of Health and Human Services and VA.~   "
1789|NCT03033758|"~     This study will be conducted in Greek population. The patients who will be selected for~     study enrollment will receive inhaled combination of budesonide and formoterol fumarate~     dihydrate at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study~     end points will be efficacy and safety in patients with asthma.Additional study objectives~     will be quality of life, patient satisfaction, severe exacerbation and comorbidities.~   "
1779|NCT03033888|"~     The long-term goal is to build a sustainable, community-based outreach program to promote~     cervical cancer screening among women living with HIV (WLH), thereby reducing related~     morbidity and mortality. The strategy for achieving this goal is to develop an intervention~     incorporating health literacy approaches and principles of community-based participatory~     research. Health literacy is a relatively new concept that has been applied mainly toward~     identifying high-risk individuals rather than toward changing health behaviors and outcomes.~     The proposed intervention is the first to integrate health literacy into educating WLH to~     promote cervical cancer screening. Community Health Workers (CHW) support has also rarely~     been incorporated into cancer screening interventions targeting WLH, making the proposed~     intervention a uniquely comprehensive approach. Building on recent successful testing by the~     investigators of a health literacy-focused intervention to promote cervical cancer screening~     in recent immigrant women, the investigators will test whether health literacy-focused~     interventions delivered by trained CHWs will be effective in promoting health literacy and~     increasing Pap test rates in a new population, WLH. The investigators hypothesize that,~     compared to WLH in the control group, WLH who receive the health literacy-focused CHW~     intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health~     literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.~   "
1780|NCT03033875|"~     The purpose of this study is to test the psychoeducational program Tele-Savvy. Tele-Savvy~     is an internet based, group education program developed from an in person program called~     Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group~     (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving~     healthy lifestyle education and then Tele-Savvy education 6 months later). Each program~     takes 43 days to complete.~   "
1781|NCT03033862|"~     Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen,~     C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor,~     p-selectin) will be measured and compared following the implantation of Bioreabsorbable~     Vascular Scaffolds and Drug Eluting Stents.~   "
1782|NCT03033849|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care~     GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott~     Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini~     Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed~     by study personnel (with the same reagent system lot used by subjects).~   "
1783|NCT03033836|"~     Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or~     lamivudine (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).~      The primary objective of this pilot study is to determine the retention in care of TGW~     treated with DTG-TDF-FTC or 3TC~      Secondary objectives:~        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;~        -  To describe the safety and tolerability of this regimen;~        -  To evaluate adherence across 48 weeks;~        -  To determine the patient satisfaction with this regimen;~        -  To identify individual, social and contextual factors associated with adherence and~          retention.~   "
1784|NCT03033823|"~     This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for~     decreasing intensity of alcohol withdrawal symptoms among inpatients requiring~     pharmacological treatment of their AWS. This double blind randomized multicenter clinical~     trial planned to treat half of participants as usal plus placebo and the other half as usual~     plus magnesium.~   "
1785|NCT03033810|"~     The study will compare two invasive methods (FFR -fractional flow reserve and~     iFR—instantaneous wave free ratio) for assessment of hemodynamic impact of coronary stenosis~     on myocardial perfusion. There is a very good correlation between these methods for the~     assessment of hemodynamic significance in a broad spectrum of lesions. However, this~     correlation decreases significantly near the cut off points for each method. The~     investigators will try to find possible explanations for these differences by detailed~     morphology assessment of coronary stenosis using optical coherence tomography (OCT),~     analysis of gene polymorphisms that play a role in vasodilatation, and by shear stress~     analysis. The head-to-head comparison between FFR and iFR is not simple, because there is no~     gold standard for assessment of hemodynamic significance. Studies comparing these methods~     have used hyperemic stenosis resistance (HSR). For this kind of measurement it is necessary~     to measure the speed of blood flow. This is usually done by a Doppler analysis of flow.~     Unfortunately, the Doppler signal can yield many artificial or erroneous indicators, and~     obtaining a good quality signal is frequently time-consuming. These are the reasons that HSR~     has not been used in routine practice. The investigators have developed a new console and~     software that can provide real time analysis of the Doppler signal. It allows us to easily~     measure HSR, and to differentiate between the FFR and iFR measures through intrabeat~     analysis of microvascular resistance (lowest microvascular resistance is an essential~     condition for proper pressure measurement). Using this tool, it is possible to automatically~     identify the point of lowest microvascular resistance during each cardiac beat. The pressure~     gradient can then be measured at that point. This approach can eliminate almost all~     uncertainties in assessment of the pressure gradient produced by coronary stenosis. This~     tool can potentially improve the existing methods used to precisely reveal a significant~     stenosis. This should increase the number of hemodynamic guided procedures.~   "
1786|NCT03033797|"~     Background: Games using motion capture from webcam have become increasingly popular. A~     population that lacks much stimulus in the teaching-learning process has under-explored the~     benefits of this kind of games: The Intellectually Disabled. The aim of this study is to~     analyse the effectiveness of games with virtual reality in the total reaction time. Method:~     A convenience sample of 165 Intellectually Disabled participants will have their performance~     measured using a virtual reality game. The intervention is to play two different games~     twice, in two sessions with an interval of, at least, seven days between the sessions.~     Participants will be randomized between two raters, both master students.~   "
1787|NCT03033784|"~     The main goal of the study is to look at the effects of intranasal oxytocin on the brain in~     Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and~     the brain. It affects a wide range of social behaviors and emotions. Investigators also seek~     to study how the effects of oxytocin treatment can be affected by genetic, immune and~     environmental factors.~   "
1803|NCT03033576|"~     This randomized phase II studies how well ipilimumab with or without nivolumab work in~     treating patients with melanoma that is stage IV or stage II and cannot be removed by~     surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the~     ability of tumor cells to grow and spread.~   "
1790|NCT03033745|"~     This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate~     safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary~     immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric~     subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of~     ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three~     cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),~     volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly~     infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push~     Flow Rate Cohort (5 to 7 infusions per week), flow rate per injection site of 25 to 30~     mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute).~     Each cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate~     cohort), repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate~     cohort). After the fourth infusion of each level, subjects may switch to the next infusion~     parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose will remain~     unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per week~     range); only the respective infusion parameter under evaluation will change.~   "
1791|NCT03033732|"~     This trial evaluates two standard of care treatments for opioid addiction: methadone and~     buprenorphine/naloxone. In order to improve patient care, the study will address real-world~     treatment conditions, including patient engagement, strict regulations for methadone dosing~     (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home~     dosing for buprenorphine/naloxone, and treatment adherence, among others. The OPTIMA study~     is designed with the intention to support patient-provider decision-making and evaluate~     health related outcomes with the overall aim of improving treatment outcomes through~     enhancing patient-centered approaches in clinical care.~   "
1792|NCT03033719|"~     The purpose of this study is to compare the postoperative global morbidity between patients~     who have been operated on for a colon cancer by laparotomy and those operated on by~     laparoscopy~   "
1793|NCT03033706|"~     Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients~     undergoing supratentorial mass excision. The investigators hypothesize that in these~     procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient~     hemodynamics intra and postoperatively.~   "
1794|NCT03033693|"~     Recent studies have shown that deep anesthesia is associated with poor outcome. There is~     still lack of randomized controlled trials with large sample size on the effect of depth of~     anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The~     investigators are performing a randomized and parallel group trial. The aim of the study is~     to determine whether there is a causal relationship between the depth of anesthesia and~     postoperative clinical outcome in patients undergoing supratentorial tumor surgery.~   "
1795|NCT03033680|"~     The specific aims of the study are:~      Primary: To determine the presence and regional distribution of microglial activation, as~     assessed by [F-18]PBR06 PET, in subjects with MSA as compared to healthy controls, at~     baseline and at 9 months follow-up.~      Secondary:~      To assess the relationship between microglial activation and clinical progression at~     baseline and follow-up.~      Hypothesis: Our working hypothesis is that there is microglial activation in Multiple System~     Atrophy and that the presence and regional distribution of microglial activation is~     different in MSA versus healthy controls and correlates with disease severity and~     comorbidities.~   "
1796|NCT03033667|"~     Comparative study between conventional fasting versus overnight infusion of lipid or~     carbohydrate on free fatty acids and insulin in obese patients undergoing elective first~     time on-pump coronary artery bypass grafting.~   "
1797|NCT03033654|"~     The investigators aim to investigate how much two consecutive applications of sunscreen~     before sun exposure can increase the quantities of sunscreen applied and decrease the skin~     area left without sunscreen compared to a single application. Volunteers wearing swimwear~     applied sunscreen in a laboratory environment twice and had pictures taken in black light~     before and after. As sunscreens absorb black light the darkness of the skin increased with~     increasing amounts of sunscreen applied. The investigators conducted a standard curve~     establishing a link between picture darkness and applied sunscreen quantity. Participants~     were asked to apply sunscreen the way they would normally do but two consecutive times. No~     other advice was given. The level of protection was determined by picture analysis as~     measurements of darkness of selected skin sites as well as the percentages of skin area left~     without sunscreen in different body regions and in total.~   "
1798|NCT03033641|"~     The purpose of this feasibility study is to further explore characteristics of ablation~     targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial~     fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the~     termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.~   "
1799|NCT03033628|"~     The aim of this study is to compare pain during maxillary infiltration local anesthesia~     injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration~     injection alone in pediatric dental patients.~   "
1800|NCT03033615|"~     This study will compare the quality of CT images acquired with very low-dose radiation and~     processed with commercially available software vs. PixelShine processed images. It would~     potentially allow imaging facilities to acquire CT scans using lower doses of radiation~     without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose~     radiation has the potential to enhance patient safety and has significant implications in~     imaging practices.~   "
1801|NCT03033602|"~     The primary goal of this study is to examine whether a brief treatment approach for PTSD is~     equally efficacious in the treatment of active duty service members relative to a first line~     treatment approach that requires much greater treatment dose.~   "
1802|NCT03033589|"~     All patients over the age of 16 undergoing primary or revision anterior cruciate ligament~     reconstruction with the use of bone-patellar-bone autograft are eligible for the study.~     Patients will be randomized pre-operatively to receive either an adductor canal nerve block~     (single injection) or a femoral nerve block (single injection). Post-operatively, the~     primary outcome measures of pain level using visual analog scale as well as narcotic and~     non-narcotic analgesic requirements will be measured.~   "
1805|NCT03033550|"~     The purpose of this study is to determine whether a mobile health educational intervention~     for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in~     Primary Care settings is a feasible behavioral intervention to integrate as a primary and~     secondary cervical cancer prevention approach.Study Design: The investigators will conduct~     an open feasibility proof-of-concept trial using a single experimental group with all~     subjects receiving the behavioral intervention being studied.~      Outcome measures. The primary outcome of interest is receipt of the first dose and~     completion of the three-dose series of HPV vaccine within 6 month of intervention, this will~     be evaluated by Electronic medical review review.~   "
1806|NCT03033537|"~     Introduction: Erectile dysfunction is a common condition with a significant effect on~     quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which~     relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation.~   "
1807|NCT03033524|"~     Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial~      Study objective:~        1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.~        2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent~          glioblastoma.~        3. Exploratory~             -  To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with~               recurrent glioblastoma~             -  To evaluate pharmacodynamic (PD) parameters by clinical biomarker test~      Study Methodology~      Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next~     arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma~     or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to~     determine the patient's safety with a decision on enrollment into the next arm or change in~     dosing frequency of study drug in the above case.~      A patient who is withdrawn from the study before the completion of the 1st cycle can be~     replaced with another patient. Patients will be treated for up to 1 year, unless a cause for~     termination occurs, such as progression of disease (PD) or the withdrawal of consent.~   "
1808|NCT03033511|"~     This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and~     multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy~     following first-line platinum-based chemotherapy.~   "
1809|NCT03033498|"~     The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of~     single, ascending doses of ABBV-951 administered by subcutaneous infusion in subjects with~     Parkinson's disease.~   "
1810|NCT03033485|"~     The purpose of this study is to assess the dosimetric properties of the positron emission~     tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily~     evaluate its diagnosis value in melanoma patients.~   "
1811|NCT03033472|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical~     periodontitis.~   "
1812|NCT03033459|"~     Breastfeeding is good for the health of both mother and baby, but many women do not~     breastfeed, or do not breastfeed for as long as they would like. The purpose of this study~     is to compare two types of interventions on how they impact breastfeeding. The interventions~     will be given during the third trimester of pregnancy, and the intervention is individual~     (i.e., one therapist and one participant). The first intervention is Motivational~     Interviewing, a type of counseling. The second intervention, or control group, is~     education on how babies grow and develop. There general aims of this study are to compare~     women in the Motivational Interviewing group and control group on how they plan to feed~     their babies, how much they learn about and their opinions about breastfeeding, and how much~     they learn about how babies grow and develop. In addition, the groups will be compared as to~     whether they start breastfeeding, and how they are feeding their baby when the baby is one~     month old.~   "
1813|NCT03033446|"~     The purpose of this study is to evaluate the effect of liver-localised radioembolization and~     nivolumab on liver cancer.~   "
1814|NCT03033433|"~     An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three~     Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on~     Treatment in Type 2 Diabetes Mellitus (T2DM) Patients~   "
1815|NCT03033420|"~     Unipolar and bipolar disorder combined account for nearly half of all morbidity and~     mortality due to mental and substance use disorders, and burden society with the highest~     health care costs of all psychiatric and neurological disorders. Among these, costs due to~     psychiatric hospitalization is a major burden. Smartphones comprise an innovative and unique~     platform for monitoring and treatment of depression and mania.~      The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients~     with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital~     Region of Denmark are invited to participate. Patients are at discharge from the psychiatric~     hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial~     consists of two separate trials according to diagnosis, bipolar disorder or unipolar~     disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback~     loop between patients and clinicians and b) context-aware CBT modules (intervention group)~     or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started~     in March 2017. The outcomes are 1) differences in the number and duration of re-admissions~     between the intervention group and the control group (primary), 2) differences in severity~     of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder);~     differences in psychosocial functioning; and differences in number of affective episodes~     between the intervention group and the control group (secondary), and 3) differences in~     perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms~     (only for patients with bipolar disorder), recovery, empowerment, adherence to medication,~     well-being, ruminations, worrying, and satisfaction between the intervention group and the~     control group (tertiary).~   "
1816|NCT03033407|"~     The aim of this study is to investigate whether adding tailored mobile coaching system to~     present community primary care for diabetes management would result in better glycemic~     control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared~     with maintaining usual diabetes management only.~   "
1817|NCT03033394|"~     Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide~     antimicrobial agents, given fears over the narrow therapeutic window of these agents and the~     serious adverse events associated with toxicity. However, in critical care the role of TDM~     for optimisation of therapy has been demonstrated to help optimise dosing of patients who~     tend to have variable pharmacokinetic parameters (J. A. Roberts et al,). This is of growing~     importance given that low concentrations of antimicrobial agents, below a micro-organisms~     minimum inhibitory concentration (MIC) is believed to be a major driver of AMR. The~     investigators set out to explore whether similar observations in PK-PD target variability~     are currently being observed across the secondary care setting (outside of critical care)~     and whether these appear to be impacting on clinical outcomes.~   "
1818|NCT03033381|"~     Here, investigators aimed to evaluate the effect of inguinal operations performed with a~     modified Ferguson technique upon testicular volume and blood flow. This study involved 23~     patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler~     ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a~     modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood~     flow were compared with the contralateral testes. Statistical Package for the Social~     Sciences (SPSS) software was used to statistically analyze the data arising; the~     Mann-Whitney U test and Friedman test were used to compare samples, and P < 0.05 was~     accepted as statistically significant.~   "
1819|NCT03033368|"~     To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from~     EFV to RPV in virologically suppressed adolescents~   "
1820|NCT03033355|"~     The purpose of this prospective research study is to evaluate higher neural changes~     following intradetrusor injection of Botulinum toxin-A (BTX-A) in patients with Multiple~     Sclerosis (MS). Concurrent Urodynamic and Functional Magnetic Resonance (fMRI) data will be~     recorded pre- and post- intravesical injection of BTX-A in patients with Multiple Sclerosis~     (MS) and neurogenic detrusor activity (NDO).~      Other objectives are to evaluate the role of urinary biomarkers such as brain-derived~     neurotropic factor (BDNF) and nerve growth factor (NGF) associated with bladder overactivity~     and, to determine whether the common validated urgency questionnaires correlate with fMRI~     findings and urinary biomarker concentration pre- and post- BTX-A injection in patients with~     MS and NDO.~   "
1821|NCT03033342|"~     A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone~     antibiotic. Cohorts of healthy adults (female and male) will participate in:~      single dose escalation study of increasing doses of MRX-4 given by mouth others will~     participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.~      other cohorts of subjects will participate in the study to evaluate the impact of~     concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4~   "
1822|NCT03033329|"~     A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone~     antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation~     study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will~     participate in a multiple dose escalation study of increasing intravenous doses of MRX-4~     given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a~     comparable intravenous dose of MRX-4 to determine bioavailability.~   "
1823|NCT03033316|"~     Oncocort Dexamethasone sodium phosphate encapsulated in so-called 'long-circulating'~     PEGylated liposomes is in development with the prospect of providing enhanced and prolonged~     lesion uptake of dexamethasone and therefore increased therapeutic benefit over existing~     formulations of dexamethasone in Multiple Myeloma. The current trial is a first-in-man study~     with Oncocort monotherapy with the objective to assess safety, tolerability, efficacy and~     dose response after short-term treatment with repeated infusions.~   "
1824|NCT03033303|"~     The purpose of this study is to test see the combined effects of the study drug called~     Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor~     (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also~     cause side effects.~   "
1825|NCT03033290|"~     Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30%~     and gradually increased annually. However, symptom relapse still bothered the majority of~     patients though there were certain advances in western medicine. In addition, side effects~     of western medicine, such as lethargy, mouth dryness were noted. Traditional Chinese~     medicine, especially qi-tonifying regimen has been used and proved benefit to the allergic~     diseases by many researchers.This study will provide the evidences of gut microbiota changes~     and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.~   "
1826|NCT03033277|"~     There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One~     of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't~     work well, and it has been shown to increase the risk of blood clots in the veins, ovarian~     cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has~     been previously documented. Herein the purpose of this work is to evaluate the therapeutic~     potential of cell therapy in women suffering from POI.~   "
1827|NCT03033264|"~     Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor~     to 4 groups depending on the mode of labor induction and BMI value:~        1. Dinoprostone in women with a BMI>30.~        2. Dinoprostone in women with a BMI<30.~        3. Cervical ripening balloon in women with a BMI>30.~        4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until~          labor, and information regarding the success of induction, mode of delivery and time of~          delivery will be collected from patients` electronic files.~   "
1828|NCT03033251|"~     Chronic obstructive lung disease is a disabling disease that affects people usually after~     several years of smoke tobacco exposure and affects millions of patients worldwide. The~     disease is marked by multiples episode of worsening, termed exacerbations necessitating~     frequent hospitalizations. During these exacerbations, patients present breathless, and in~     the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory~     assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal~     mask (referred to non-invasive ventilation, NIV), that helps patients to cope with their~     breathless. The mask is not always well tolerated and the ventilator sessions are delivered~     intermittently. In the past decade, a new technique that provides air-oxygen with high flow~     has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver~     from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal~     cannula. Recent studies have shown that the technique is very efficient to treat patients~     presenting with acute respiratory failure who don't have any underlying chronic pulmonary~     disease. Whether the technique would be also efficient in patients with COLD presenting with~     severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it~     is thought that the comfort of the patient would be much better in comparison to NIV and~     could potentially help to treat many patients with the disease. The objective of the present~     study is to study the physiological effect of HFNC as compared to NIV in patients with~     severe exacerbations of COPD and to show that it is non-inferior to NIV.~   "
1831|NCT03033212|"~     This investigation will assess how the timing and type of rehabilitation after a~     transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.~     The efficacy of the procedure will be evaluated through patients' quality of life, measured~     by health-related quality of life questionnaires up to 24 months following the procedure.~     These measures will be compared to the patients' baseline value.~   "
1832|NCT03033199|"~     Primary immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder,~     accounting for about 1/3 of clinical hemorrhagic diseases. Loss of immune tolerance leading~     to increased platelet destruction and decreased platelet production is the main pathogenesis~     of ITP. Dysbiosis of the gut microbiota was found in many autoimmune diseases like rheumatic~     arthritis(RA),inflammatory bowel disease(IBD),multiple sclerosis and probiotic treatment or~     fecal microbiota transplantation(FMT) which can regulate the gut microbiota has good~     clinical efficacy in those disorders. One ITP patient with ulcerative colitis(UC) was~     treated with FMT and got progressive but significant increase in platelet level and lasted~     for several years.~   "
1833|NCT03033186|"~     Metastatic (HR-positive, HER2-negative) breast cancer (BC), advanced or unresectable~     neuroendocrine tumours of pancreatic (pNET), gastrointestinal or lung origin and metastatic~     renal cell carcinoma (mRCC) are diseases with poor outcome. Everolimus increases patients'~     median progression-free survival (PFS) with 4.6 months in metastatic BC (mBC), 7 months in~     (p)NET and 3 months in mRCC. However, serious adverse events (AEs) occur frequently. This~     reduces effectiveness of everolimus, because AEs are managed with dose reductions, treatment~     interruptions or even complete discontinuation of everolimus.~      Therapeutic-drug-monitoring (TDM) is used to adjust the prescribed daily dose, to maintain~     effective everolimus whole blood concentrations, with the lowest possible risk of AEs. While~     everolimus TDM has been common in transplantation medicine, it has not been implemented in~     oncology.~      The importance of TDM in oncology is supported by previous research which showed that a~     2-fold increased everolimus whole blood trough concentration was associated with a~     short-term risk of grade ≥ 3 pneumonitis, stomatitis and metabolic events. Moreover, an~     exposure-toxicity relationship of everolimus in patients with thyroid cancer was observed,~     since initial everolimus concentrations could be associated with early toxicity (< 12 weeks,~     e.g. stomatitis). However, the association between initial everolimus measurements and~     long-term AEs (≥12 weeks, e.g. pneumonitis, anorexia and anemia) of any grade and the need~     for everolimus dose reductions could not be made. Since levels ±>18 µg/L were associated~     with toxicity, the investigators assume that the upper therapeutic window of everolimus in~     the oncologic setting will be ±18 µg/L. Similarly, a tendency to improved PFS and overall~     survival was observed when Cmin in steady state was above 14.1 μg/L. This seems to be the~     lower limit of the therapeutic window.~      Before consensus about the feasibility of everolimus TDM in the oncologic setting can be~     achieved, a number of questions (the knowledge gaps) need to be answered: 1. It is unknown~     whether everolimus whole blood trough levels (over time) predict long-term AEs. 2. The~     optimal concentration range for everolimus, with the treatment of mBC, mRCC, or (p)NET is~     unknown, especially the upper limit associated with toxicity. 3. It is unknown what~     everolimus concentration level is associated with the need for everolimus dose reductions.~   "
1834|NCT03033173|"~     An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and~     compared between carpal tunnel syndrome patients and healthy volunteers.~   "
1835|NCT03033160|"~     The specific aim of this protocol is to determine whether vaginal estrogen is an effective~     treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators~     hypothesize that women who use vaginal estrogen for three months will be more likely to have~     resolution of their asymptomatic microscopic hematuria compared with women who do not use~     vaginal estrogen.~   "
1836|NCT03033147|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative~     pain and swelling in adult patient with symptomatic apical periodontitis.~   "
1837|NCT03033134|"~     The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in~     Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism~     in Japanese Clinical environment~   "
1838|NCT03033121|"~     Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered~     daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is~     often not complied. The auxological effect of three injections per week (TIW) regimen is~     controversial, while the metabolic effects were never evaluated in children. The objective~     of this study was to evaluate whether two different regimens of weekly injections could lead~     to similar auxological and metabolic effects in children with GHD.~   "
1839|NCT03033108|"~     This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy~     secondary to Stargardt disease.~   "
1840|NCT03033095|"~     The aim of this trial is the caracterisation of a predicting algorithm of the answering~     response for patients with etanercept treatment in spondyloarthritis disease.~      This algorithm will help to target patients patients who have a risk / benefit important for~     etanercept treatment.~   "
1841|NCT03033082|"~     Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the~     persistent inability to obtain and/or maintain a penile erection that is hard enough for~     satisfactory sexual intercourse. The number of reported patients with ED is increasing and~     it is becoming a real medical problem.~   "
1842|NCT03033069|"~     To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as~     monotherapy or combination therapy (Zoloft) in adults with PTSD.~   "
1843|NCT03033056|"~     Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One~     central, yet largely understudied, abnormality in anxiety disorders is the heightened~     tendency to display fear and avoidance in reaction to benign or safe events that resemble~     feared situations. The current project maps brain circuits associated with this abnormality~     in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.~   "
1844|NCT03033043|"~     This clinical trial is a prospective, multicenter, non-blinded, non-randomized study~     designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated~     type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days~     post-procedure.~   "
1890|NCT03032445|"~     Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are~     eligible, based on inclusion criteria, to participate in this research study that is seeking~     to determine whether supplementation of beer (alcohol) immediately following a long distance~     ultramarathon race can positively impact exercise-associated hyponatremia [EAH].~   "
2015|NCT03030820|"~     This will be a prospective study of cirrhotics and healthy controls comparing their oral~     microbiota, endotoxemia and systemic inflammation at baseline and at 10 and 30 days after~     clinically indicated systematic oral cleansing and interventions as well as 3-month and 6~     month hospitalizations post-cleaning.~   "
11054|NCT02912494|"~     The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa~     and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease~     (CKD).~   "
1845|NCT03033030|"~     Breast cancer remains a worldwide big killer with a rate of deaths compared with newly~     diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the~     early detection of clinically occult breast cancer. Mammography is established as the~     primary investigation for population-based breast cancer screening. Advances in mammographic~     technique regarding both hardware and software applications are still not sufficient to~     overcome mammography's limitation with regard to both sensitivity and specificity. Depending~     on several factors, such as age and breast density, mammography screening is associated with~     a false-negative rate of 10-20 %.~      Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast~     using 3D reconstructions of the tissue from multiple low-dose digital mammographic images~     acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the~     number of lesion visible due to the reduction of overlapping breast tissue.~      In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow~     the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of~     discrete projection images while the breast remains in compression. The individual~     projection images are extremely low in dose, so the composite dose incurred during a TS~     acquisition may be similar to that of a standard 2D mammography. The radiologically dense~     breasts are associated with decreased sensitivity of mammography, both in the clinical and~     screening setting as well as its established association with breast cancer risk. The~     systematic application of ultrasound (US) in women with radiologically dense breasts and~     negative mammogram has been shown to be associated with an additional cancer detection rate~     [7,8,9]. Incremental ultrasound detection of cancer may be considered in the range of 0.27%~     to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the~     main limitation of US in breast screening is represented by false- positive findings. These~     findings result in additional investigation or unnecessary surgical biopsy [10].~   "
1846|NCT03033017|"~     This is a two-center study of 30 HIV-infected participants who have been on antiretroviral~     therapy (ART) for at least two years.~      Participants will be asked to undergo LN and GALT biopsies both before and after a closely~     monitored analytic treatment interruption (ATI).~   "
1847|NCT03033004|"~     Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three~     treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion~     Cryolipolysis. The region will be treated according to the individual need, in the region of~     abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60~     and 90 days after randomization. Blood collections will also be performed at baseline and~     between 14 and 21 days after randomization for evaluation of lipid profile and liver~     function.~   "
1848|NCT03032991|"~     The prospective multicenter study GD-Brain provides a better knowledge on the basis of~     neurological impairment in children born to mothers with gestational diabetes (GDM). GDM~     modifies placental structure and affect materno-fetal nutrient transfer. Docosahexaenoic~     acid (DHA) play an important role on neurodevelopment, and it is reduced in venous cord~     blood of newborns born to GDM. In previous studies, we have already demonstrated impaired~     DHA fetal levels not only using label fatty acids with stable isotopes administrated to~     pregnant women, but also in observational studies in GDM as the prevention of obesity study~     (PREOBE study) in Granada and other similar study in Murcia. The impaired cord DHA levels~     were associated to disturbed neurodevelopment in these children during the first year of~     life. However, it is uncertain the mechanisms underlying this impaired materno-fetal DHA~     transfer and implications for later life.~      The recent publication in Nature Journal of a selective transmembrane carrier for DHA in~     brain named major facilitator superfamily domain 2a (MFSD2a) open new expectations. We~     detected disturbed MFSD2a levels in placentas from GDM which could be due to structural~     problems in this organ; inflammation, oxidation and metabolic changes related to diabetes~     might affect MFSD2a activity. Moreover, it is difficult to know whether disturbed MFSD2a~     levels in placenta may also indicate altered levels of this carrier in the brain from~     children born to GDM mothers, which could contribute to neurodevelopment impairment in these~     subjects. Recent studies also indicate that obesity alters the biosynthesis of eicosanoids~     derived from DHA, with a decrease of protectins and resolvin of D-series, which have~     powerful anti-inflammatory properties.~      The main aim of this study is to analyse potential differences on neurodevelopment, and~     brain structure and functioning, in children 8 years old born to GDM respect to those born~     to healthy normoweight mothers, as well as to identify early biomarkers consistently related~     to neurodevelopment from early stages of life.~   "
1849|NCT03032978|"~     Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in~     two-step indirect pulp treatment: Randomized clinical trial~   "
1850|NCT03032965|"~     The purpose of this study is to determine if additional ablation during the first procedure~     as the result of the ability to medically induce quiet atrial arrhythmias will improve~     clinical outcome in patients with atrial fibrillation thus decreasing the need for~     additional ablation procedures.~   "
1851|NCT03032952|"~     This was a 12-week, parallel randomised controlled trial, including a 6-week follow-up. The~     trial compared a group of university students (N = 84) receiving a mobile CBT application~     intervention (Feel Stress Free) to a wait-list control group (N = 84) receiving no~     intervention. Participants were asked to complete the Hospital Anxiety and Depression Scale~     (HADS) and the Patient Health Questionnaire (PHQ-9) at baseline (as part of the screening~     questionnaire) and then fortnightly for the 12 weeks. Although blinding was not possible~     owing to the nature of a wait list control group, researchers did not have any face-to-face~     contact with the participants, as recruitment and participation in the study was entirely~     completed online.~   "
1852|NCT03032939|"~     Intraoperative stress responses (vasoconstriction and changes in heart rate) and~     postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes~     in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter~     (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious~     stimuli-induced stress responses (vasoconstriction) have not been studied on the DC~     component of PPG. The aim of this study was to investigate the effect of a known noxious~     stimulus (endotracheal intubation) on both the AC and DC components of PPG.~   "
1853|NCT03032926|"~     The goal of this proposed study is to identify a potential biobehavioral marker of CBT~     outcome in the most common child and adolescent anxiety disorders, including separation~     anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to~     replicate in a clinical sample the previous finding from animal and non-clinical human~     samples that a difference exists in extinction learning across development.~   "
1854|NCT03032913|"~     The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis~     of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry~     the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will~     examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of~     patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.~   "
1855|NCT03032900|"~     This study aims to describe incidence of right ventricular dysfunction after major lung~     resection with echocardiography criteria.~   "
1918|NCT03032081|"~     The investigators will assess the efficacy and safety of utilizing high-intensity interval~     training in stable heart failure patients on functional outcomes. Specifically, an~     assessment of baseline peak oxygen uptake and peak cardiac output will be assessed before~     and 8 weeks after intense interval training. Measurements of quality of life will be~     assessed before and after training as well as the number of arrhythmic events before and~     after training. The control group will be a group that will follow a moderate exercise~     training protocol over a similar period.~   "
1856|NCT03032887|"~     The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response~     syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is~     steadily rising in Germany. The hands of the staff and visitors are the most important~     transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures~     for the prevention of hospital infections. The different measures of hand hygiene serve to~     protect against the spread of contamination of the skin with obligate or potentially~     pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited~     extent (especially in pregnant women and neonates in perinatal care centers) the primary~     prophylactic measures are of great importance.~      While the importance of hand disinfection in the staff has been undisputed, there is no data~     on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these~     stations are common non-compliant persons (especially children!). On the other hand,~     pregnant women and young mothers and newborn babies are exposed to a large number of~     visitors compared to other stations.~      The investigators examine whether special measures (such as voice prompts) have a positive~     effect on the rate of performed hand disinfections or consecutively on the infection rate.~   "
1857|NCT03032874|"~     Patient age 45 year old and above who presented with rectal bleeding at three tertiary~     hospitals in South West Nigeria were invited for colonoscopy. The clinical information of~     the patients and the colonoscopy data were analyzed~   "
1858|NCT03032861|"~     This study aimed investigate the chronic effect of orange juice consumption on gut~     microbiota and in the bioavailability of flavanones and metabolites by feces, blood and~     urine analysis.~   "
1859|NCT03032848|"~     To evaluate the difference of three vaginal estrogens creams comparative with placebo on~     improvement of hormonal cytology, local and systemic climacteric complaints, as well as its~     endometrial security.~   "
1860|NCT03032835|"~     Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder~     characterized by calcification of dermal arterioles.~      There are significant gaps in the understanding of the pathophysiology and risk factors for~     calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare~     incidence and lack of collaborative approach have been some of the major limiting factors~     towards treating calciphylaxis.~      The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within~     calciphylaxis research by utilizing existing and, when necessary, developing new~     infrastructure to support the consent of patients and the collection of dedicated samples~     for a calciphylaxis repository.~   "
1861|NCT03032822|"~     At the Ohio State University, and across the country, surgical patients admitted to the~     hospital are over-prescribed a significant amount of opioid medications upon discharge to~     home. Recent studies reveal that a large percentage of patients prescribed opioid~     medications after surgery have approximately half of the prescribed medication left over.~     This study aims to evaluate reported opioid use after surgery in patients undergoing~     cystectomy in order to better approach the issue with current opioid use and abuse trends~     while still providing adequate medical care and pain management to patients.~   "
1862|NCT03032809|"~     The aims of this study are to optimize MR imaging and MR angiography sequences and image~     reconstruction for 3T magnetic resonance imaging system scanners, which are already used in~     the clinical environment on patients with or with suspected intracranial vasculopathies.~     Improvements in these areas will have positive implications for medical diagnosis and~     treatment.~   "
1863|NCT03032796|"~     The primary goal of this project is to evidence potential synergistic benefits on cognitive~     control processes using a video game (Body-Brain Trainer, or BBT) that integrates~     cognitive and physical challenges in a complimentary fashion. Healthy adults will be~     recruited for a longitudinal experiment and randomly assigned to one of four study groups to~     mechanistically tease apart the possible presence of any synergistic effects on cognitive~     abilities through the combination of cognitive & physical challenges.~   "
1864|NCT03032783|"~     This phase II trial studies the how well donor stem cell transplant works in treating~     patients with high risk hematologic malignancies. Giving total-body irradiation and~     chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone~     marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may~     also replace the patient's immune cells and help destroy any remaining cancer cells.~   "
1865|NCT03032770|"~     Placenta accreta is a substantially life threatening condition and one of the causes of~     maternal morbidity and mortality in the world. According to study done in United Kingdom,~     The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities~     overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta~     previa. in a tertiary south Italian center, The incidence increased from 0.12% during the~     1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of~     placenta accreta was 3.7 per 1000 deliveries.~   "
1871|NCT03032692|"~     The study was designed to evaluate the impact of a novel kinematic biofeedback system -~     SWORD - in the motor performance of patients after stroke. The SWORD system combines~     inertial motion trackers and a mobile app, allowing digitization of patient motion and~     providing real-time audiovisual biofeedback.~      The investigators hypothesize that the biofeedback feedback provided by the SWORD system~     improves patient performance, defined as an increase in the number of correct movements.~      The design of the study is a cross-over randomized clinical trial. Patients will be~     randomized into two groups. Both will perform two separate sessions consisting of one~     exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both~     experimental settings: with and without biofeedback. Group 1 will perform the exercise with~     biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform~     the exercise in the opposite order. The SWORD system will be used to record movement data in~     both sessions, but the feedback was only active in one of them.~   "
1937|NCT03030859|"~     This randomized pilot clinical trial studies how well the self-care program works in head~     and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote~     self-care activities for managing chronic swelling and tough/tight tissues in the head and~     neck region.~   "
1866|NCT03032757|"~     Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with~     functional impairment and physical disability in the elderly. Maintenance or growth of~     muscle mass is mainly driven by increased muscle protein synthesis (i.e. the generation of~     new muscle protein) in response to exercise and feeding. However, several investigations~     have shown that elderly individuals have a blunted protein synthetic response following~     protein intake. This inability of the elderly to properly respond to growth stimuli has been~     termed anabolic resistance and plays a significant role in the development of sarcopenia.~     However, the precise mechanisms underpinning anabolic resistance are unknown.~      It is well established that muscle protein synthesis at the molecular level is regulated by~     a cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been~     shown to associate with lysosomes, i.e. the intracellular organelles responsible for the~     breakdown of cellular proteins, and subsequently moving towards the cell periphery.~      This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the~     activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1~     activation in response to amino acids. Thus, dysregulation of lysosomal movement in ageing~     muscle may represent an underlying mechanism in the development of anabolic resistance.~     However, this area of research is unexplored in the context of human skeletal muscle. The~     investigators hypothesize that dysregulation of lysosomal movement plays a central role in~     the development of age-associated skeletal muscle anabolic resistance.~   "
1867|NCT03032744|"~     Project IMPACT is a school-based health center intervention program that institutes~     guideline-based chronic asthma care and provides supervised administration with daily~     preventive asthma medications to improve asthma symptoms and lung function, reduce emergency~     visits, and decrease missed days of school among children from communities with health~     disparities.~   "
1868|NCT03032731|"~     Many healthy lifestyle interventions have been developed to help people change their~     activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes~     (T2DM) and cardiovascular disorders (CVD). However, these interventions often fail to engage~     their target audience, which undermines their effectiveness in changing behaviour and health~     outcomes.~      The purpose of this study is to investigate the efficacy of a self-directed, website-based~     intervention to promote physical activity and healthy dietary behaviours. The intervention~     frames health information from a novel perspective, which our previous work has indicated~     can help to promote interest in the health information and improve attitudes, self-efficacy~     and motivation towards physical activity and healthy dietary behaviours.~      The intervention comprises a website of information resources and personal recording areas~     to set goals and monitor activity and diet, weekly emails and pedometers. In this trial we~     aim to see whether the intervention has any impact on people's physical activity and diet,~     as well as their risk of developing CVD and T2DM. The intervention will be compared with a~     control condition in which participants will be shown standard resources available on NHS~     websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be~     recruited from the community. The active intervention will last 6 weeks (during this period~     participants will receive weekly emails from the research team) and there will be a 6-week~     follow-up phase (in which participants will still have access to the website but contact~     from the research team). Activity, diet, disease risk markers and psychological antecedents~     of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up~     (12- weeks).~   "
1869|NCT03032718|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically~     meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic~     agents, causing severe sensory and/or motor deficits such as pain, altered sensation,~     reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and~     higher risk of falling. It is associated with significant disability and poor recovery, not~     only reducing patients' autonomy and quality of life but also limiting medical cancer~     therapy, which subsequently may affect the clinical outcome and compromise survival. To~     date, CIPN cannot be prevented and approved and effective treatment options are lacking.~      Promising results regarding CIPN have recently been achieved with exercise. Own preliminary~     work revealed that patients profit from sensorimotor training (SMT), experiencing~     significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated~     whole body vibration training, a further neuromuscular stimulating exercise intervention.~     Results suggest that whole body vibration (WBV) is not only feasible and safe for~     neuropathic cancer patients but can attenuate motor and sensory deficits.~      We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a~     follow-up period), including 44 patients with neurologically confirmed CIPN, in order to~     evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the~     patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will~     include compound muscle action potentials, distal motor latency, conduction velocity, and~     F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction~     studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of~     mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and~     biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as~     pain, quality of life and the level of physical activity. Patients will be assessed before~     and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will~     be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up.~      We hypothesize that individually tailored whole body vibration training will reduce relevant~     symptoms of CIPN. Our results could contribute to improve supportive care in oncology,~     thereby enhancing patients' quality of life and coincidentally enabling the optimal medical~     therapy.~   "
1870|NCT03032705|"~     The purpose of this study is to compare esthetic, functional and biological properties of~     two restoration materials used to fill cavities. One material is called Herculite™ Ultra,~     which is a traditional tooth colored resin composite that is placed in the cavity in layers~     and hardened with UV light. The second material is called SonicFill™ 2, which is a bulk~     fill composite that uses an ultrasonic hand piece (SonicFill 2010) to change the material~     from a solid into a liquid in order to place it into the cavity. This material can be placed~     in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA~     approved as non-significant risk devices for filling cavities, but Herculite™ Ultra is more~     widely used in dental clinics.~      In each subject, one tooth with a cavity will be randomly selected to receive one filling~     material, and a second tooth with a cavity will be randomly selected to receive the second~     material. The fillings will be observed over a two year period to determine clinical~     acceptability.~   "
1887|NCT03032484|"~     Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.~   "
1888|NCT03032471|"~     The primary objective of this multicenter observational study is to determine the effect~     size of the relationship between DCI and neuropsychological impairment 14-28 days and 3~     months after aSAH.~      Secondary objectives are the feasibility to administer and the validity of the MoCA in an~     intensive care unit setting, as well as the test/retest reliability of the MoCA in patients~     with acute brain damage in absence of aSAH.~   "
1872|NCT03032679|"~     After Institutional Review Board approval, adult patients scheduled for total knee~     arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a~     24 month period. Interim analyses of cases who have completed the 6 month follow up as on~     31st October, 2017 will be analyzed as part of the co- principle investigator's thesis. All~     consenting patients will be assessed for pain preoperatively, the first 3 post-operative~     days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the~     Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute~     Pain Service team as per standard protocols.~      The Brief pain inventory (BPI) (short form with translations, obtained with permission from~     MD Anderson), which assesses pain severity and its impact on daily functions will be~     administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6~     months postoperatively.~      The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition~     (impairment) after completed tumour treatment will be estimated at the end of 6 months from~     the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable~     screening tool to identify the likelihood of a neuropathic pain component in patients and~     validated in various languages including Hindi and Marathi will be administered~     preoperatively and at 1, 4 and 6 months after surgery.~      Details of postoperative chemotherapy and radiation will also be obtained from patient's~     notes and the electronic medical record. If the patient cannot follow up at the said~     intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in~     prepaid envelopes would be given to them at discharge which they would have to duly fill in~     and post them to the given address at the appropriate intervals if they cannot visit the~     pain clinic. At the 6th month of follow up, they would be requested to visit the pain clinic~     for an assessment of MSTS score and completing the BPI and PD-Q.~      INCLUSION CRITERIA:-~        -  Adult patients above 18 years of age, undergoing TKR~        -  Literate: able to read and write in at least one of the following languages English,~          Hindi and Marathi~        -  Willing to fill forms and post them and/or answer questions on phone~      EXCLUSION CRITERIA:-~        -  Refusal of consent~        -  Cognitively impaired~        -  Revision TKRs (including cases with wound wash and nail spacer cementing)~   "
1873|NCT03032666|"~     Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in~     transfusion-dependent patients with HCV genotype 1-6~      Secondary Objective(s):~      Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs.~     relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1,~     F2 by elastography~   "
1874|NCT03032653|"~     This single-centre historical control group comparative study will compare outcomes of~     surgically-treated rotational ankle fractures and the current routine practice of early~     protected weightbearing and range of motion with immediate unprotected weightbearing as~     tolerated and range of motion after ankle open reduction and internal fixation.~   "
1875|NCT03032640|"~     The purpose of this study is to collect data to examine whether short-term consumption of~     non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood~     sugar levels and in the composition of the bacteria in the large intestine.~   "
1876|NCT03032627|"~     The purpose of the research is to help researchers understand changes in metabolism in~     patients that develop heart failure.~   "
1877|NCT03032614|"~     This is a phase II clinical trial of the combination of carboplatin, eribulin, and~     Veliparib.~   "
1878|NCT03032601|"~     Multiple Sclerosis (MS) is a disease in which the myelin surrounding the nerve cells is~     damaged which affects functioning. MS usually is treated with medications designed to reduce~     the occurrence of future MS events. Evidence suggests that an important part of the disease~     process is damage to the myelin and brain caused by too much oxygen (sometimes called~     oxidative stress) or too much inflammation (or swelling).~      The overall goal of this study will be to determine whether NAC will help to support~     cerebral function in patients with Multiple Sclerosis (MS). This PET-MRI study will utilize~     FDG PET to measure cerebral metabolism, along with MRI analysis, to measure metabolism and~     structural effects of NAC in patients with MS.~   "
1879|NCT03032588|"~     The main purpose of this study is to assess the safety and tolerability of a single dose of~     JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on~     PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine~     produced from Salk poliovirus strains (cIPV) as reference.~   "
1880|NCT03032575|"~     1. To determine the prevalence and incidence of anal HSIL and associated risk factors among~     MSM who initiate ART during AHI.~   "
1881|NCT03032562|"~     Using an extensive set of both volitional and non-volitional tests of respiratory muscle~     function and strength it is the aim of this study to~        -  identify disease-specific patterns of respiratory muscle impairment in different NMD~          and COPD~        -  establish which set of tests is predictive of sleep-disordered breathing or daytime~          hypercapnia in patients with NMD or COPD, respectively.~        -  to investigate the decline of respiratory muscle function in patients with progressive~          NMD and COPD along with sleep studies and capnography~   "
1882|NCT03032549|"~     This study will examine a Ready to Drink (RTD) supplement.~   "
1883|NCT03032536|"~     This is an open-label, randomized, multi-part study to evaluate the relative oral~     bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under~     fasted and fed conditions (Parts 1 and 2) and the drug-drug interaction between AL-3778 and~     entecavir or tenofovir disoproxil fumarate (Part 3).~   "
1884|NCT03032523|"~     Hypoglycemia is the most common metabolic problem faced after birth. We will be studying the~     utility of using a continuous glucose monitoring(CGM) system to more closely monitor low~     blood sugars in newborns. We will evaluate the number of hypoglycemic events detected using~     CGM and compare it to those detected using current standard of care screening methods.~   "
1885|NCT03032510|"~     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of~     eravacycline compared to ertapenem in treating participants with complicated urinary tract~     infections (cUTI).~   "
1886|NCT03032497|"~     The feasibility study proposed here will primarily examine the sensitivity of an~     electroencephalogram (EEG)-based Brain Computer Interface (BCI) in detecting significant~     differences in brain signals in patients with chronic low back pain (N=10), lower limb pain~     (N=10) and healthy controls (N=10) through perceived movements via a video and during actual~     movements. The BCI device has been approved for use in previous trials (e.g. NNI-IRB/07/001,~     DSRB Domain D/09/608, DSRB Domain D/10/072) and the safety and effectiveness of this~     non-invasive EEG-based BCI device validated through these trials. However, the validation~     has not been specific to its use in pain. Related to the primary objective of the study, we~     will develop and validate an adaptive and participant-specific pain detection and analysis~     program by exploring and identifying discriminative and robust patterns in spontaneous EEG~     from our study sample.~      For the secondary objective, we will develop and validate a BCI and computer based pain and~     attention diversion training system with interactive audio-visual feedbacks for Phase 2 of~     the study. These feedbacks will inform the user about the current brain activation level and~     attention level, and guide the user in learning to modulate the EEG characteristics and~     develop skills to manage attention to alleviate perceived fear-related pains. The BCI system~     captures EEG signals and decodes the underlying brain states in relation to cognition and~     fear-related pain perception. Such decoded brain states are then presented to the~     participant in visual or other form to guide the participant to learn to regulate the brain~     states towards better pain management. For example, the participant may over a few sessions~     learn to focus on the visual feedback while inhibiting the brain function activity in~     relation to fear-related pain perception. With practice, the user is encouraged to achieve~     brain activity modulation without external feedback so fear-related pain can be reduced in~     realistic situations.~   "
1891|NCT03032432|"~     The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed~     rotator cuff tendinosis, will have their pain and function improved when treated with daily~     use of a dynamic elastic garment along with a corticosteroid injection, when compared to~     those patients who receive a corticosteroid injection alone. To our knowledge this is the~     first study to evaluate the use of a dynamic elastic garment on shoulders.~        -  Group A: Control group, will receive and ultrasound-guided corticosteroid injection~          alone.~        -  Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of~          a dynamic elastic garment.~      Up to 60 patients will participate and be randomized in this study, both male and female~     between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES,~     Simple Shoulder test, these will take place at the initial visit and Then again at your 4~     week and 6 week visit.~      This is a single center study, investigator initiated. 60 subjects will participate in the~     study at Loma Linda University.~   "
1892|NCT03032419|"~     The trial is a phase III, non-inferiority, observer-blind, randomised, controlled,~     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and~     IPV SSI (reference vaccine)~   "
1893|NCT03032406|"~     To evaluate the feasibility of administering HCQ, EVE or the combination in patients who~     have completed primary therapy for breast cancer and harbor bone marrow disseminated tumor~     cells.~   "
1894|NCT03032393|"~     This study determines the effects of posture on time up and go test. Half of the subjects~     will assume a high-power posture, while the other half will assume a low-power posture.~   "
1895|NCT03032380|"~     To compare all-cause mortality at Day 14 of S-649266 with that of the comparator, meropenem,~     in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial~     pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by~     Gram-negative pathogens.~   "
1896|NCT03032367|"~     This is a randomized, open-label, cross-over study comparing the bioequivalence of~     bedaquiline administered in whole tablet form versus bedaquiline administered in crushed~     (experimental) form in healthy adult volunteers.~   "
1897|NCT03032354|"~     They are major genera of bacteria that make up the colon flora in human, constitute~     intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal~     barrier and modulate local and systemic immune responses. Changes in gut microbiota can~     influence the immune system by increasing gut permeability, intestinal inflammation, and~     impaired oral tolerance in type 1 diabetes.Taken together, the data imply that~     bacteriotherapy may potentially be used as a tool to modulate the immune system for~     preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and~     Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women~     and reduced the frequency of gestational diabetes mellitus~      Aim of the study:~      The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell~     function in children with newly diagnosed type 1 diabetes: a randomized, double blind,~     placebo-controlled trial.~      Primary end point:~      Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min~     following the start of the meal~      Intervention:~      Included patients will be randomly assigned to receive a combination of Lactobacillus~     rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group )~     during six months.~      The expected results:~      Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell~     function shown in the properly performed, methodologically accurate study would create a~     rationale for its routine use in patients with newly diagnosed type 1 diabetes.~   "
1898|NCT03032341|"~     The purpose of this research study is to find out if mobility (the ability to move around)~     can be reliably assessed by having the family or care giver caregiver take a video based~     test for the patient. If this study shows that mobility can be assessed by family or~     caregiver, this information can be used in situations where mobility cannot be measured~     directly in patients. A total of 60 patients and 60 family/caregivers at Wake Forest Baptist~     Medical Center will take part in this study. Patients physical function will be assessed~     using a test that uses short movie clips to assess mobility. Patients will be asked to watch~     ten short (~10 seconds each) movie clips that describe various tasks such as climbing up~     hills or walking and estimate if they can perform the tasks. The familymember/caregiver will~     be also asked to answer the questions on behalf of the patient. The family member/caregiver~     will be asked to return to take the same test in the next 1-14 days. The patient will be in~     the study for one day. There is no intervention, this is observational.~   "
1899|NCT03032328|"~     In previous work the investigator identified a group of children between the ages of 10-18~     years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic~     tests has unexpectedly revealed underlying cardiovascular instability manifesting as~     orthostatic intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS)~     (88%). While this is an atypical initial presentation for orthostatic intolerance in~     general, the investigator believes that the cardiovascular problem is serious and represents~     a cause of the nausea in a majority of these individuals, as treatment of the POTS with~     fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates~     the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct~     the tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an~     elevation in MAP in supine position, which may lead to future cardiovascular problems such~     as early onset hypertension and cardiac hypertrophy. This argues for a different treatment~     approach. The investigator presents preliminary data in this application revealing that OI~     subjects tend to have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.~   "
1900|NCT03032315|"~     randomized, open-label, single dose, replicate crossover clinical trial to compare the~     pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of~     telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers~   "
1938|NCT03030846|"~     The purpose of this study was to evaluate the effects of stabilization exercises on pain,~     disability and pelvic floor muscles function in patients with lumbopelvic pain.~   "
1939|NCT03030833|"~     The purpose of the study is to assess device performance in the presence of carbon monoxide.~   "
1940|NCT03031834|"~     Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were~     randomized to receive quinapril or no treatment for 2 years.~   "
1901|NCT03032302|"~     Traumatic brain injury (TBI) refers to neuronal damage occurring as the result of an~     external force being applied to brain tissue. In the United Kingdom annual figures~     (2013-2014) show 449,000 hospital admittances with a diagnosis of head injury with males up~     to five times more likely to sustain a head injury than females. Traumatic brain injury~     (TBI) causes life-long disability, with no significant reduction in life expectancy,~     affecting a diverse range of cognitive and social functions including memory, task planning~     and execution, impulse control, social interactions, personality changes and depression.~     Following traumatic brain injury acquired deficits can lead to problems with resumption of~     aspects of daily life, particularly in terms of returning to work and interpersonal~     relationships.~      The initial injury triggers a secondary cascade of metabolic, neurochemical and cellular~     changes within the brain, primarily aimed at limiting damage and stimulating repair.~     Paradoxically prolonged secondary cascade mechanisms, including haemorrhage, oedema,~     neuroinflammation and axonal injury, results in exacerbation of deficits observed. The~     heterogeneous on-going nature of the secondary cascade presents clinicians with~     opportunities to intervene in an attempt to limit neuronal damage. A large body of~     nutritional research has been focused on addressing the hypermetabolic and catabolic states~     created by secondary cascade processes in the acute stage. Addressing these demands has~     played a significant role in reducing mortality and infection rates following head injury,~     however there has not been the same depth of research investigating the post-acute period~     (once individuals are discharged from hospital).~   "
1902|NCT03032289|"~     This study aims to investigate the association between active transport and the incidence of~     acute myocardial infarction in England.~   "
1903|NCT03032276|"~     Primary objective of the study is to measure the impact of a comprehensive package of~     interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on~     neonatal mortality in three Upazila of Chandpur district, Bangladesh~   "
1904|NCT03032263|"~     Nasal intubation is frequently used for dental procedures to promote an unimpeded view of~     the oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal~     tube (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits~     upward toward the forehead. This unique shape ensures that the tube will not interfere with~     surgical exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the~     trachea using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this~     is possible without an adjuvant, but frequently a pair of specially shaped forceps, known as~     Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to~     the curvature of these ETT. Magill forceps are introduced into the mouth and are used to~     grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the~     current literature suggests, it has been our experience that nasal intubations using the~     C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL.~     This technique may improve the time and ease to intubation because of not having to use the~     Magill forceps. The use of Magill forceps can be awkward for the clinician, with poor~     visualization due to obstruction of the view by this tool in the airway, and small working~     space within the posterior oropharynx. For these reasons, the possibility of not having to~     use Magill forceps because the investigators are using a C-Mac as the only tool to intubate~     is a potentially inviting one.~   "
1905|NCT03032250|"~     This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver~     support in patients with stage I-IV head and neck cancer. Prepare to Care kit may increase~     knowledge about head and neck cancer and enhance stress-management skills.~   "
1906|NCT03032237|"~     Rationale: Undernutrition risk among community-dwelling older adults in developed countries~     is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well~     as efficacious to reduce undernutrition in community-dwelling older adults. A promising~     strategy to increase protein intake among older adults, is to offer dietary solutions with~     normal foods that fit their current daily eating patterns. For this reason, home-delivered~     protein-rich readymade meals and protein-rich dairy products will be studied in this~     research.~      Objective: The primary objective is to study the effectiveness of commercially available~     protein-rich readymade meals and protein-rich dairy products in increasing protein intake of~     older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary~     objectives include: studying effects of these meals and dairy products on total daily energy~     intake. Further, studying the acceptance of and compliance to the meals and dairy products.~      Study design: The study will be performed as a single-blind randomized, controlled,~     four-week trial in a real-life setting: in community-dwelling older adults' own homes.~      Study population: The target group of this study are community-dwelling older adults who use~     a meal-delivery service.~      Intervention: Both groups will receive readymade meals for each day during 4 weeks. They~     will also receive dairy products to freely consume during the intervention period. The~     intervention groups receives protein-rich meals and protein-rich dairy products, the control~     receives standard meals and food products.~      Main study parameters/endpoints: Difference in daily protein intake between intervention and~     control group. Secondary parameters: energy intake and acceptance (liking).~   "
1907|NCT03032224|"~     The occurrence of dysphagia is a well-known early feature of esophageal cancer that may~     reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a~     consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in~     patients with esophageal cancer before and after surgery is not well known and its possible~     consequences have been debated.~      Aim: The aim of this study was to prospectively explore body composition and function in a~     cohort of patients with esophageal cancer before and after surgery with curative intent. In~     particular, to investigate the prevalence and development of sarcopenia and body composition~     as a consequence to surgery for esophageal cancer and the possible relation to morbidity,~     length of stay and quality of life (QoL).~      Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned~     for surgery with a curative intent, data on body-composition measured with bioimpedance,~     working capacity (cardiac stress test), grip strength and QoL (European Organisation for~     Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version~     3.0) were prospectively collected. Data regarding dysphagia was derived from an esophagus~     related quality of life form (EORTC QLQ-OES18). Data on tumour stage and type,~     complications, length of stay and preoperative weight loss were collected from medical~     charts.~   "
1908|NCT03032211|"~     1. Summary of Clinical Investigation~      A summary of the clinical investigation is provided below and includes the primary objective~     of the study, the safety and feasibility endpoints, the number of subjects to be enrolled,~     the study duration, the subject follow-up and the inclusion/exclusion criteria.~        1. Primary Objective~           The primary objective of the study is to evaluate the safety and feasibility of the~          alfapump® System indication for use in the management of fluid in NYHA Class III and~          ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60~          mL/min/1.73m2.~        2. Study Endpoints~             1. Primary Safety Endpoint~                The primary safety endpoint will be an assessment of the occurrence of adverse~               events (AEs) and serious adverse events (SAEs) related to:~                  1. Surgical implant of the alfapump®~                  2. Device malfunctions~                  3. Dialysate infusion~             2. Secondary Safety Endpoints~                The secondary endpoint will be an assessment of:~                  1. Time to first hospitalization related to fluid management after the~                    activation of the alfapump® System and initiation of dialysate infusion has~                    occurred~                  2. Rate of occurrence of re-hospitalizations related to fluid management~                  3. All-cause mortality~             3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The~               feasibility of the alfapump® System for management of fluid in NYHA Class III and~               ambulatory NYHA Class IV heart failure patients with renal dysfunction will be~               assessed by the net fluid balance as measured by the ability of the alfapump®~               System to move more fluid to the bladder than dialysate instilled.~   "
1909|NCT03032198|"~     Thyroid Feasibility Study~   "
1910|NCT03032185|"~     Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all~     women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes,~     urogenital pain, headache and pains in the musculoskeletal system. That happens due to the~     decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused~     by a complex autonomic activity. For pain management, a therapeutic electrical stimulation~     of the peripheral nervous system promotes modulation of nociceptive incentives and release~     of endogenous opioids. According to reviewed studies, the use of transcutaneous electrical~     nerve stimulation (TENS), by directly stimulating the central nervous system, has presented~     results of manipulation of the autonomic system, being observed change in heart rate and~     cognitive improvement in dementia. Given this possibility, the present study aims to~     investigate whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency~     can generate autonomic and psychophysical changes in healthy postmenopausal women.~      Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on~     autonomic and psychophysical parameters in postmenopausal women.~      Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected~     according to inclusion and exclusion criteria previously established. The autonomic and~     psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned~     Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively),~     as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep~     Quality Index). After application of the scales, the participants will be subject to active~     Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as~     randomization. All the research subjects will be invited to participate in the study and~     sign an Informed Consent and Informed (ICI). This study will be registered in the Clinical~     Trials.~   "
1911|NCT03032172|"~     This is a multi-center, exploratory, non-comparative and open-label study to investigate the~     safety, tolerability, pharmacokinetic (PK) and PK/pharmacodynamic (PD) relationship of~     RO7034067 in adults and children with Type 2 and Type 3 Spinal Muscular Atrophy (SMA) who~     have been previously treated with a survival of motor neuron 2 (SMN2)-targeting therapy.~   "
1912|NCT03032159|"~     Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between~     parents and their children's' primary care providers about asthma. The overarching goal of~     this study is to reduce disparities among a population with high rates of pediatric asthma~     morbidity. The investigators are testing the efficacy of a short message service~     (SMS)-enhanced health communication (HC) intervention (Text2Breathe) designed to equip~     urban, low-income parents with tools for communicating effectively with their children's~     primary care provider (PCP).~   "
1913|NCT03032146|"~     The aim of this study is to examine the contribution of a cardiac rehabilitation program on~     the active participation in daily life six months after an acute coronary event.~      100 patients will be recruited for the study, 3-10 months after a myocardial infarction and~     hospitalization in the Emek Medical Center in Afula, Israel.~      50 patients recruited for the study who had participated in cardiac rehabilitation will be~     the experimental group. 50 patients who have not participated in rehabilitation- will be the~     control group. The groups will be matched for diagnosis, sex and age. Sociodemographic data~     on patients will be taken from the medical records of the cardiology department and the~     Cardiac Rehabilitation Institute of the Emek Medical Center..~      Course of study: Participants will sign an informed consent form and fill out questionnaires~     that evaluate active participation in the community. In addition, the physical function and~     muscle strength of the participants will be evaluated with designated tests. The duration of~     each meeting will be 60 minutes.~      HYPOTHESES~        1. Patients who participate in a cardiac rehabilitation program will exhibit higher~          indices of participation in the community than patients who do not participate.~        2. Patients who participate in a cardiac rehabilitation program will display higher levels~          of physical activity when compared with patients who do not participate.~   "
1914|NCT03032133|"~     Patients are randomized to receive pain control after Total Knee Arthroplasty with either a~     regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and~     mobility is asessed.~   "
1915|NCT03032120|"~     This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ),~     processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on~     postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin),~     anti-oxidatant status, and prospective food intake in lean and obese subjects.~   "
1916|NCT03032107|"~     This research study is studying a combination of drugs as a possible treatment for~     metastatic breast cancer.~      The interventions involved in this study are:~        -  Pembrolizumab~        -  Trastuzumab emtansine (also called T-DM1)~   "
1917|NCT03032094|"~     The purpose of this study is to test if the thickness of the graft taken from the roof of~     the mouth, has a significant effect on the amount of attached tissue and the amount of root~     coverage that are attained when treating a single tooth with gingival recession.~   "
1941|NCT03031821|"~     This is a multi-centre, double-blind, randomized phase III trial comparing metformin to~     placebo in patients with advanced prostate cancer starting intermittent androgen deprivation~     therapy.~   "
14397|NCT02868814|"~     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained~     release tablets versus placebo for fibromyalgia~   "
1919|NCT03032068|"~     Home monitoring technologies have recently emerged in many different areas of healthcare.~     These technologies are being used to provide rehabilitation to patients, and to prevent,~     identify, and manage complications. The investigators are proposing a method to monitor and~     communicate with patients during the first 12 weeks after total knee arthroplasty (TKA)~     using an electronic home-based patient monitoring system with unique connectivity~     capabilities and prescriptive controls. The investigators will prospectively, electronically~     capture range of motion and gait parameters at specified intervals using Bluetooth sensors~     worn by the patient. The unique in-home patient monitoring platform will be utilized by 10~     TKA patients once they return home following surgery. The investigators hypothesize that the~     use of an internet based home patient monitoring technology platform will reliably provide~     information related to the patients' pain and function and enhance patient feedback and~     communication after TKA. The hypothesis will be tested with the following aim: 1) To test~     the reliability of all technology utilized within the patient's home including but not~     limited to the sensors, the communication controller, the patient interface (Android tablet)~     and the internet by prospectively comparing between data collected through the home~     monitoring technology and traditional clinical measurements taken during physical therapy~     and surgical follow-up visits.~   "
1920|NCT03032055|"~     Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is~     the first cause of death, particularly when complicated by an acute chest syndrome (ACS).~      The PRESEV score could help the physicians to better manage VOC and could be used for future~     therapeutic trials. This predictive score of secondary ACS has to be validated in a~     multicenter international study.~   "
1921|NCT03032042|"~     Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond~     targeted PCR testing to next generation sequencing techniques. In addition, the current~     state of monitoring for soil-transmitted helminth infections is moving increasingly from~     microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted~     helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool~     samples are logistically challenging and time-intensive to collect, thus participation is~     often far from optimal. Rectal swabs are more efficient and may result in higher~     participation. In this study, children will be randomized to either albendazole,~     azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be~     collected. The investigators will compare the PCR test for soil transmitted helminth~     infections using both the rectal swabs and the bulk stool samples. In addition, the~     investigators will analyze the gut microbiome of the children using next generation~     sequencing techniques to gain insight into effects of mass drug administration.~   "
1922|NCT03032029|"~     The European ASV Registry (short name) will investigate the use of Adaptive~     Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of~     ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with~     regards to patient characteristics and to document adverse events related to therapy for a~     therapy safety analysis. A pilot phase will enrol at least 200 patients to test the~     feasibility of the registry. After the pilot phase will be completed and an intermediate~     data analysis had been performed, the registry will be expanded over several countries~     across Europe with the goal of enrolling up to 1000 patients over a period of 5 years.~   "
1923|NCT03032016|"~     Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe~     Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of~     haematopoietic stem cell transplantation (HSCT), the pharmaceutical company that~     manufactures Defitelio® (Gentium, a Jazz Pharmaceuticals Company) - as a specific obligation~     (SOB) - has been required by PRAC to set up a disease registry to collect safety and outcome~     data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This~     registry is a Post Authorization Safety Study (PASS), which is being coordinated through the~     European Society for Blood and Marrow Transplantation (EBMT). Following appropriate consent,~     data from patients who undergo haematopoietic stem cell transplantation are routinely~     collected at the local centre for the EBMT database. For this study, the sites are being~     asked to collect additional anonymised clinical data from patients who develop this~     complication or who have been treated with Defitelio® for other reasons than sVOD. The study~     simply requires collection of data which is already recorded in the patient charts, but not~     routinely collected.~      The study DOES NOT involve decisions about treatment, which are clinical decisions, but~     merely collection of data for patients who develop this complication, whether or not they~     receive treatment and for patients who are treated with Defitelio® for any other reasons.~   "
1924|NCT03032003|"~     To investigate if oral administration of 240mg PAC of cranberries can reduce the number of~     episodes of acute bacterial cystitis and improve general QoL in women with recurrent~     bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the~     adverse effect profile of the drug will be reported.~      Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from~     the outpatient population who present to their family physician or specialist with~     symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will~     be divided in groups according to their age. Urinary culture, vaginal and rectal swab will~     be taken from all the patients. Antibiotic treatment will be prescribed (using the drug of~     choice according to the urine culture and the treating physician choice). Subsequently, they~     will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean~     240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment~     and after a negative urinary culture patients will continue to receive per os, daily, one~     capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.~      Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine~     collection, vaginal swabs and rectal swab will be taken at study entry and at the month 3,~     6, 9 and 12 visits.~      Participants will be asked about medication usage, any side effects they may be experiencing~     at each study visit. If participants develop a UTI at any time during the study, they will~     be asked to visit the study site within 24 hours.~   "
1984|NCT03031262|"~     In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML)~     patients who have reached CR are randomised into two groups and receive high-dose cytarabine~     (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is~     evaluated.~   "
1925|NCT03031990|"~     Psychological stress and its sources differ among the population and can be reduced in~     various ways. The practice of yoga has been shown to be an effective stress reducing agent.~     IVF processes have also been shown to increase stress levels, particularly in patients with~     multiple failed IVF cycles. Less is known about stress levels in patients undergoing~     elective egg freezing for fertility preservation. The investigators demonstrated in a pilot~     project that yoga postures with a yoga focused discussion session decreases stress in~     infertility patients compared to controls. The goal of this study is to further explore the~     capability of yoga practice to reduce stress in a specific subset of infertility patients,~     those with a history of at least one failed IVF cycle and those undergoing elective oocyte~     cryopreservation. Additionally, the investigators are aiming to understand which aspect of~     the intervention (discussion vs. yoga) had the most impact and whether route of~     administration of the intervention (in person vs online) effects results.~   "
1926|NCT03031977|"~     The aim of the present study was to evaluate the effect of visceral mobilization on symptoms~     of functional constipation and static balance in stroke survivors.~   "
1927|NCT03031964|"~     This study will evaluate patients receiving a multihole revision acetabular implant for~     total hip arthroplasty and will be followed for 10 years to collect data on survivorship of~     the implanted prosthesis.~   "
1928|NCT03031951|"~     Given the lack of support for lifestyle management in post-career and considering the high~     rates of physical inactivity and overweight in former elite athletes, the aim of this~     research project is to analyze the efficacy and effectiveness of a lifestyle intervention in~     former athletes.~   "
1929|NCT03031938|"~     A4091065 is a multicenter, prospective, cohort study with enhance physical an~     neurodevelopmental surveillance to characterize the outcomes related to the development of~     infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or~     comparator via maternal exposure or in utero in any tanezumb study.~   "
1930|NCT03031925|"~     There is substantial clinical and biological intra and inter-patient variability in SLE.~     Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening,~     leading to increased morbidity and mortality.~      Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE~     patients.~      Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models~     and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic~     cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines~     and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR~     expression in SLE is significantly higher and significantly correlated with disease~     activity.~      Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or~     heterotetramer and is implicated in several biological processes. Most notably, it binds to~     ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling~     pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated~     with SLE.~      ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with~     ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out~     in Amiens' University Hospital showed that vascular lesions in lupus nephritis were~     associated with a significant increase in vascular expression of ANXA2.~   "
1931|NCT03031912|"~     This is a randomized, placebo-controlled, multi-site, double-blind trial of V920~     (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be~     conducted in conformance with Good Clinical Practices. The study will take place at 2~     Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital)~     and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le~     Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including~     screening.~   "
1932|NCT03031899|"~     Abstract~      Objective:~      To study the diagnostic efficiency of Rose Bengal with Toluidine blue in detecting the~     biopsy sites and thus establish an accurate diagnosis in oral premalignant lesions.~      Materials and method:~      In our study 27 patients with 41 lesions were included. Since one patient had not quit the~     habit in the two weeks following initial examination and another lesion disappeared in the~     waiting period, 2 patients (3 lesions) were not included in the study. Out of 38 lesions~     diagnosed based on clinical criteria, 32 were leukoplakia, 5 lichen planus and 1 SCC. After~     initial examination they were subjected to Rose Bengal and Toluidine blue stain. If stained~     positive they were subjected to biopsy.~   "
1933|NCT03031886|"~     Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose~     profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.~   "
1934|NCT03031873|"~     Brain arteriovenous malformations are abnormal communications between brain arteries and~     veins with an intervening tangle of abnormal arteries (nidus). Brain AVMs may be~     asymptomatic or symptomatic, presenting with acute hemorrhage or neurological symptoms.~     Brain AVMs that have not bled carry a yearly risk of intracranial hemorrhage of~     approximately 4% (Ondra et al.).~      The management is multidisciplinary involving neurosurgeons, interventional~     neuroradiologists, radiation physicians, neurologists and allied health care personnel.~     Patients may be treated with open neurosurgery, endovascular embolization, radiation therapy~     or any combination of these treatments. The goal of the treatment is to eliminate the brain~     AVM while preserving normal flow to the surrounding normal arteries. This involves~     obliteration of the shunting of blood via the AVM arteries to veins by a variety of~     treatments. The treatment regimen is individualized dependent on natural history, the~     angioarchitecture, location, risk of treatment(s) and patient wishes.~   "
1935|NCT03031860|"~     Cough strength score will give true prediction of Extubation outcome~   "
1936|NCT03031847|"~     This pilot will enroll 50 HF patients (age ≥ 80 years) undergoing CRT device implantation at~     the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State~     University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P~     versus CRT-D and followed until study end. Rates of patient screening, enrollment,~     randomization, and retention as well as cost of care will be examined. The results of this~     pilot study will inform the design of a large pivotal non-inferiority trial and will be~     necessary for its success. Patients who refuse participation in the randomized pilot trial~     will be asked to enroll in a prospective observational cohort. Characteristics of patients~     who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their~     device decision will be measured.~   "
1942|NCT03031808|"~     When a surgical procedure is performed under general anesthesia, the Airways are often~     secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies~     have shown a reduction of these side effects when by use of muscle relaxants or a lidocain~     spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the~     two methods or nothing. These methods will be studied systematically.~      Heart rate and blood pressure rise during the intubation procedure. The investigators will~     also study the differences between the groups.~   "
1943|NCT03031795|"~     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is~     used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after~     surgical procedures. When taken orally, it should not cause sedation. The purpose of this~     study is to determine if oral ketorolac is effective at reducing pain during IUD placement~     versus a placebo tablet.~   "
1944|NCT03031782|"~     This is a double-blind, placebo-controlled, event-driven randomized withdrawal study to~     investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic~     Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related~     Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period)~     consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a~     randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment~     Period 2.~   "
1945|NCT03031769|"~     An observational, multinational, cross sectional study to describe 24-hs symptoms, physical~     activity and their relationship in stable COPD patients in Europe~   "
1946|NCT03031756|"~     The aim of this clinical study was to evaluate the clinical efficacy of using perio flow~     adjunctively with mechanical instrumentation on periodontal parameters and halitosis.~      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the~     study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control~     groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile~     sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately~     after treatment, and at 7 days, 14 days and 1 month.~   "
1947|NCT03031743|"~     This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial~     in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition~     and diversity of infants who do (control) and do not (case) demonstrate immune~     seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose,~     age and breast-feeding practices.~   "
1948|NCT03031730|"~     This phase I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 when~     given together with carfilzomib, lenalidomide, and dexamethasone in treating patient with~     multiple myeloma that has come back of has not responded to previous treatment. Drugs used~     in chemotherapy, such as MDM2 inhibitor AMG-232, carfilzomib, lenalidomide, and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading.~   "
1949|NCT03031717|"~     Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence~     of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased~     intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and~     stagnant flow.~      Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS)~     is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will~     review the safety and outcomes of this approach.~   "
1950|NCT03031704|"~     Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be~     removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this~     technique, albeit less dangerous than surgery, is associated with complications such as~     haemorrhages, perforations, and more relapse than that can be observed for colorectal~     adenomas. As no prospective data have been published this French multicenter study aim to~     analyze results of this technique under standardized and secured procedure.~      All investigators are expert in therapeutic endoscopy in tertiary centers and are member of~     a group of clinical researcher involved in that field ( GRAPHE  (Groupe de Recherche et~     d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly~     expected among the international society of gastroenterologists who need to confirm the~     efficacy of endoscopy and define optimal conditions for performing adenomas resection in~     this location Primary End Point is the two years recurrence rate. Secondary End Points are~     frequency and type of complication after standardized endoscopic mucosectomy of duodenal~     adenomas, frequency and type of complications after a second endoscopic mucosectomy and~     patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm~     requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients~     with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions,~     familial adenomatous polyposis and use of antiplatelet agent during the five last days.~      Hundred and twenty patients will be included and followed 2 years after mucosectomy.~   "
1951|NCT03031691|"~     A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in~     Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal~     Cancer.~   "
1952|NCT03031678|"~     The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were~     enrolled in the pivotal study to assess long-term safety and device performance.~   "
1953|NCT03031665|"~     Using an innovative multi-modal imaging approach, this study investigates the role of the~     neurochemical gamma-aminobutyric acid (GABA), brain activity, as well as hormones in~     understanding sex differences in Major Depressive Disorder (MDD). Further, the investigators~     will link these markers to symptoms of depression.~   "
1954|NCT03031652|"~     Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia~     between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h~     after surgery was assessed and compared using a visual analog scale.~   "
1955|NCT03031639|"~     The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This~     registry tries to collect the outcomes including quality of life and complication for both~     endoscopic and conventional thyroidectomy methods.~   "
2223|NCT03028116|"~     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial~     that explored the safety and immunogenicity of single dose a allantoic split inactivated~     seasonal influenza vaccine in healthy adults.~   "
1956|NCT03031626|"~     The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air)~     compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the~     central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome.~      Despite the vast amount of research investigating the cause of central sleep apnea, there~     remain gaps in knowledge, lending to further research efforts. The decision to compare~     oxygen to medical air is based on several theorized mechanisms. The first of which is the~     supposition that provision of medical air may act as an arousal stimulus for the~     hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic~     challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response~     in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen~     really plays a significant role in treating CSA. Lastly, the delivery of medical air via~     nasal prongs may provide sufficient arousal to terminate the cycle of events leading to~     central apnea, as described by Urquhart et al.~      A deeper understanding of central sleep apnea is essential to ameliorating its adverse~     sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and~     academic difficulties.~   "
1957|NCT03031613|"~     To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral~     pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted~     laparoscopic radical prostatectomy (RALRP)~   "
1958|NCT03031600|"~     The objective of this study is to determine the accuracy of estimating patient blood volume~     using field-expedient point-of-care measurement of hematocrit before and after hemodilution~     with a standardized volume of intravenous solution, in comparison to determining patient~     blood volume by radiodilution. A total of 33 healthy adult male subjects aged 18-35 years~     will undergo determination of blood volume in a fixed order: first by radiodilution, then by~     hemodilution. Blood volume as measured by radiodilution will be correlated with blood volume~     as estimated with hemodilution to assess the potential validity of hemodilution as means of~     estimating blood volume.~   "
1959|NCT03031587|"~     Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias~     resistant to medication. However, the absence of assessment of injury creation during~     radiofrequency application is an important issue. One of the objectives of the Institut~     Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is~     to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on~     thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time~     visualization of tissue temperature in all the myocardium with sufficient spatial and~     temporal resolution to characterize the induced thermal lesion. Today, investigators have~     developed and validated a new method for cardiac thermometry, associating rapid MRI~     acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and~     correction algorithms against residual motion, magnetic susceptibility, drift of the~     magnetic field, etc... Recent preclinical studies showed a precision of 1°Celsius in the~     myocardium, largely sufficient to characterize a thermal treatment induced by radiofrequency~     where typical temperature rises of 40°C are observed during ablation. Temporal evolution of~     the temperature in each pixel provides access to calculation of the accumulated thermal dose~     that is a relevant indicator of the induced necrosis.~      This imaging method must now be evaluated in humans in order to test its robustness under~     real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize~     acquisition parameters and image processing. The aim of this research is thus to obtain~     specific MRI sequence of images of patients, on which will be evaluated the different~     algorithms of reconstruction and processing for temperature imaging. This study is a~     mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under~     MRI.~   "
1960|NCT03031574|"~     The purpose of the study is to evaluate the effect of food, gender, and age on the~     single-dose pharmacokinetics (PK) of SUVN-D4010.~   "
1961|NCT03031561|"~     This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting~     breast microcalcifications in patients undergoing biopsy for a breast abnormality.~     Ultrasound sends sound waves into the body, and the sound waves reflected back are~     interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the~     brightness and gives color to the ultrasound images, which may allow doctors to better~     identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast~     that cannot be felt but can be detected by imaging. A group of microcalcifications may~     indicate that cancer is present.~   "
1962|NCT03031548|"~     Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube~     (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all~     intubations result in inappropriate ETT placement. An adult study has shown that ultrasound~     point-of-care is superior to auscultation in determining the location of ETT. This study~     aims to determine if point-of-care is useful in determining ETT position in children.~   "
1963|NCT03031535|"~     The purpose of the study is to investigate the drug octreotide acetate in a new intranasal~     formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The~     two octreotide acetate formulations will be evaluated following separate administrations for~     safety and tolerability including any side effects, the speed at which the drug is absorbed~     and eliminated in the body, and the ability of the drug to lower the levels of growth~     hormone (GH) and insulin-like growth factor 1 (IGF-1).~   "
1964|NCT03031522|"~     The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive~     and repeatable detecting EGFR-activating mutational status.~   "
1965|NCT03031509|"~     The purpose of this study is to evaluate the efficacy and safety of human amniotic~     epithelial cells transplant in nonunion of limb fracture patients.~   "
1985|NCT03031249|"~     In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated~     acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The~     control group receive high-dose cytarabine(HDAC) regimen while the experimental group~     receive high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The~     safety and efficacy of ATRA and ATO is evaluated.~   "
2012|NCT03030898|"~     The idea of this work came during a carotid surgery, when we noticed a respiratory variation~     of the right internal jugular vein. Also, because of the interest of evaluating the preload~     dependence during an intervention or reanimation where it is difficult to access the other~     monitoring methods . The aim of the study was to test the hypothesis that respiratory~     changes in right internal jugular vein diameter are similar to respiratory changes in~     superior and inferior vena cava in mechanically ventilated patients and therefore help to~     predict fluid responsiveness.~   "
2013|NCT03030885|"~     The main purpose of this study to determine the safety of an experimental medicine called~     131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by~     the U.S. Food & Drug Administration (FDA).~   "
1966|NCT03031496|"~     The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide~     (HCTZ) (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure~     and hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed~     to determine whether the test product GSK3542503 is bioequivalent to the reference (ref)~     hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult~     participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a~     phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling~     approximately 42 healthy participants at a single center. Study participants will be~     randomized to one of two treatment sequences (A-B or B-A) in accordance with the~     randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a~     hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B~     (Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed~     dose combination), will be administered on Day 1, in each treatment period. Each participant~     will participate in both treatment periods and receive a single dose of each treatment. The~     treatment periods will be separated by a washout period of at least 7 days and no more than~     14 days. The total duration in the study for each participant is expected to be 5 to 7~     weeks, from screening to his or her last visit. A maximum of 42 participants will be~     randomized such that at least 32 evaluable participants complete the study.~   "
1967|NCT03031483|"~     Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard~     treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy~   "
1968|NCT03031470|"~     Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of~     different origin, as well as for a number of inborn metabolism disorders and liver tumors.~     The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1~     million population per year.~      Experimental and clinical evidence demonstrate the harmful short and long-term effects of~     ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention~     performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main~     reasons for the increased length of hospitalization, the high cost of treating patients~     during the post- surgery period, the development of persistent early allograft dysfunction~     or loss, frequent crises of acute rejection, acute renal and multiple organ failure, and~     mortality of the operated patients.~      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin,~     which is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8), as an~     agent to prevent early allograft dysfunction caused by ischemia-reperfusion injury in~     patients undergoing orthotopic liver transplantation.~   "
1969|NCT03031457|"~     Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis~     (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.~     Significant morbidity and mortality is associated with VTE events. This disease entity~     represents the most common cause of preventable in-hospital death as evidenced by over~     100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,~     with annual costs to the U.S. healthcare system in excess of $7 billion.~      Cancer patients have been identified as a particularly vulnerable patient population. Of~     these, breast cancer patients represent the largest group treated by plastic surgeons. An~     increasing number of breast reconstructions are performed in the U.S. with a documented 35%~     increase in the annual number of breast reconstructions since 2000. Over 106,000 breast~     reconstructions were performed in 2015 alone.~      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is~     associated with the highest risk for VTE. We believe that a key element rendering these~     patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This~     is supported by the observation that VTE risk remains elevated for up to 12 weeks~     postoperatively. We hypothesize that lower extremity deep venous system stasis is a~     procedure-specific key contributing factor to postoperative VTE risk.~      This study examines the duration of postoperative lower extremity venous stasis to identify~     patients who might benefit from extended chemoprophylaxis. First, we will use Duplex imaging~     technology to examine the lower extremity deep venous system preoperatively, on~     postoperative day 1, and on the day of discharge to determine if patients display~     radiographic evidence of lower extremity venous stasis at the time of hospital discharge.~     Next, we will determine if the use of bridging mesh repair of abdominal fascia will decrease~     the degree and duration of postoperative lower extremity venous stasis. Finally, we will~     examine the association between bridging mesh repair of abdominal fascia and abdominal bulge~     and hernia rate at 1 year.~      A better understanding of pathophysiologic mechanisms that contribute to the development of~     VTE as well as surgical means that reduce VTE risk factors have the potential to optimize~     VTE prophylaxis, thus, favorably impacting clinical outcome in a large patient population.~   "
1970|NCT03031444|"~     This study was designed to analyze the prognosis and recurrence predictive factors of high~     risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.~      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was~     compared for these patients.~   "
1971|NCT03031431|"~     Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care~     (KMC) is a safe and effective method of warming; however, it is not always feasible, and not~     possible in settings such as resuscitation or clinical instability. Electric warmers are the~     standard of care in developed countries, but are extremely costly, complicated with risk of~     causing both hypo and hyperthermia with misuse, and often not feasible in settings without~     stable electricity. Through a multi-institutional collaboration, the investigators have~     developed an electricity-free infant warmer. After laboratory based prototype testing for~     safety and efficacy, the investigators aim to study the supervised use of the warmer under~     routine implementation conditions in a resource-limited setting.~   "
1972|NCT03031418|"~     The purpose of this research study is investigate a new and validated urine test which~     predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The~     current protocol has two objectives; one is to further assess and evaluate the performance~     of the urine test in men already scheduled for initial prostate needle biopsy (cohort~     (group) 1) and two, to evaluate how the results of the urine test influences the decision~     process for determining whether to perform a prostate biopsy (cohort (group) 2).~   "
1973|NCT03031405|"~     The purpose of the study is to examine whether oxytocin and oxytocin receptor gene~     polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.~   "
1998|NCT03031080|"~     The BOND study is a prospective, randomised single blinded controlled trial to assess the~     effect of night splinting in patients who have had collagenase injection and manipulation~     therapy for Dupuytren's Contracture.~   "
2014|NCT03030872|"~     The objective of this study is to compare the diagnostic value of MR DSC-Perfusion~     (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM~     Vue PACS (investigational device) to the Olea Sphere PACS with Perfusion and DWI Modules~     (predicate device). Therefore, there will be several separate objectives depending on the~     type of acquisition:~   "
11983|NCT02900586|"~     The purpose of this study is to contribute to the evaluation of SIOUX study by adding data~     about the choices of the observant patients, the mis-observant ones or the protocol~     deviations.~   "
1974|NCT03031392|"~     Bleeding on probing demonstrated to have high specificity with certain level of sensitivity~     to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the~     implant surface is imperative to discern on the probe penetration extent and subsequent~     bleeding. In the presence of inflammation, bleeding should be present indicating high~     sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition~     does not seem to translate high specificity. In this sense, it is noteworthy to mention that~     the mucogingival shift after implant placement often decreases the presence of keratinized~     mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon,~     bleeding on probing, although might reliably indicate presence of disease, it does not seem~     to be a suitable diagnostic parameter. On the other side, suppuration characterizes the~     necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a~     sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in~     early stages where bone resorption has not occurred yet, it might be a consequence of a~     foreign body reaction (i.e., residual cement or floss).~      Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always~     incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this~     case-control study was to assess the diagnostic accuracy of peri-implantitis-related~     clinical parameters compared to otherwise healthy dental implants.~   "
1975|NCT03031379|"~     Randomized controlled trial assessing the safety and benefits of shortening preoperative~     fasts on intubated ICU patients undergoing tracheotomy.~   "
1976|NCT03031366|"~     TIPS creation has been widely used to treat the complications associated with portal~     hypertension. In association with increased operator experience and the ongoing development~     of imaging modalities, the rate of major complications associated with TIPS has decreased~     signifcantly in the past decades. However, the passage of a curved needle from the hepatic~     vein into the portal vein still remains a challenging and time-consuming part of the~     procedure and is associated with puncture-related complications that are potentially~     fatal.Three-dimensional raodmap guidance has been widely applied in various inverventions.~     The aim of the present study is to prospectively assess the feasibility and effcacy of~     real-time 3D roadmap guidance during TIPS creation.~   "
1977|NCT03031353|"~     Neonatal respiratory distress may occur in either term or preterm newborns with a higher~     relative risk in preterm, and whether born vaginally or through caesarean section, but in a~     higher percentage after elective caesarean section whose rate is rising.~      Prostaglandins may be given about one hour before an elective caesarean section after~     excluding the presence of contraindication to their use to decrease the neonatal respiratory~     diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that~     occurs frequently in children who had previously TTN will diminish.~   "
1978|NCT03031340|"~     To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses~     postoperative) will reduce the postoperative opiate requirements of patients undergoing~     spinal fusion surgeries of two or more vertebrae.~   "
1979|NCT03031327|"~     A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.~      Patients with ocular discomfort following refractive surgery procedure (within 6 months from~     enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day~     15±2 days) and at Week 3 follow-up visit (day 22±2, or early exit).~   "
1980|NCT03031314|"~     Barbed suture use has been gaining increased acceptance and has been reported to offer~     potential advantages in wound closure of hip and knee replacement surgeries.~      The goal of this study is to compare joint replacement patient outcomes who receive a~     knotless barbed suture versus a traditional suture (randomized into two arms). The~     traditional suture used at our joint replacement program is defined as: interrupted sutures~     to close the retinaculum followed by running monocryl sutures for skin closure. Both~     knotless barbed suture and the traditional sutures have similar suture size.~      Patient outcomes examined will be patient range of motion (recorded daily) and complications~     with wound healing (evaluated periodically in-person at post-operative visits).~      Secondary outcomes examined will include wound drainage on dressings by surface area and~     weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.~   "
1981|NCT03031301|"~     The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled~     study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation~     in subjects with functional constipation.~      Two arms will be assessed:~        -  Vibrant Capsule administered 5 times per week~        -  Sham Capsule administered 5 times per week~      Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 8 weeks.~      Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.~      Subjects will be asked to refrain from taking any medication or supplement to relieve their~     constipation, during the entire study period.~      After the 14 days of run-in period, the subjects will return and eligibility will be~     re-assessed. Subjects will be trained on how to use the base unit and will swallow the first~     capsule on site the day of baseline visit. They will activate and ingest the rest of the~     capsules at home by themselves, using the base unit.~      Subjects will be instructed to complete a simple subject eDiary each day throughout the~     duration of the study. A final visit will take place at the end of the 8 week treatment~     period.~      Subjects will receive phone calls at least once a week and subject compliance will be~     monitored during the 8 weeks of the study.~   "
1982|NCT03031288|"~     Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow~     patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of~     gastroesophageal reflux disease (GERD).~      In this crossover-randomized study, we compared the effects of standard feeding bottles (A)~     versus vented base feeding bottles (B) on a group of patients with at least 2 clinical GERD~     symptoms. 24 hours of synchronized cardiorespiratory (CR) and Esophageal Multichannel~     intraluminal impedance (MII/pH) monitoring were evaluated for each patient. During this~     period, patients were fed alternatively with feeding bottle A and B.~   "
1983|NCT03031275|"~     Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center~     Karolinska.~      Patients: adult survivors treated with ECMO for severe refractory respiratory failure at~     least 5 years earlier.~      Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary~     function testing, exercise tolerance, quality of life and mood disorder screening.~   "
1986|NCT03031236|"~     Background (brief):~        1. Burden: The uniqueness of each child is tremendously influenced by interaction between~          nature and nurture during critical period of brain development that promotes foundation~          of brain architecture through neuronal connections.~        2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and~          psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental~          illiteracy, maternal depression and lack of stimulation, all of which are preventable.~          Little is reported about any comprehensive package of development that addresses most~          of these early childhood risks and promotes optimum early childhood development (ECD).~        3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost,~          and feasible center based approach that focuses on positive parenting of children~          during early life that will promote early stimulation, minimize childhood maltreatment,~          boost up of maternal self-esteem and healthy thinking and improve health and~          nutritional (HN) status of children.~      Hypothesis (if any):~      This integrated intervention will promote maternal child-care practices and mental health~     that will finally improve their children's growth, micro-nutrient status, early brain~     development compared to control group.~      Objectives:~      To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,~     child development along with effect on maternal child-care practices and mental health.~      Methods:~      Randomly selected 2 groups will be identified as intervention and control (150 mothers'~     from15 clusters in each group). Mothers of 8-23 months old children living in slums and~     practice harsh child-disciplining will be identified as study population. The mothers of~     intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will~     include combined messages on a) psycho-social stimulation, b) positive parenting to prevent~     child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d)~     health and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of~     over 6 month-period). The control group will only receive the usual health messages provided~     by the government.~      Outcome measures/variables:~        -  Children's cognitive, motor, language and socio-emotional development; anthropometry;~          hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)~        -  Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.~   "
1987|NCT03031223|"~     Spinal cord injuries have become increasingly frequent due mainly to the increase in urban~     violence. The growing number of automobile collisions and violence-related events merits~     particular attention, as such occurrences can lead to death or disability stemming from a~     spinal injury. The severity of the consequences depends on the location affected and degree~     of destruction of afferent and efferent spinal cord pathways, with higher, more extensive~     injuries leading to less physical fitness and functional independence. Unfortunately,~     injured neurons of the central nervous system are unable to regenerate following a spinal~     injury and spinal cord regeneration is therefore a major challenge to researchers in the~     fields of neuroscience and neurologia. Upon receiving an external stimulus, the central~     nervous system is believed to adapt and reorganize itself using mechanisms to compensate for~     neuronal loss and promote, even if partially, the remodeling of remaining synaptic~     connections, leading to new neuronal sprouting. Low-level laser therapy (LLLT) has proven to~     be a possible option for the stimulation of the repair process in the central nervous~     system. It is plausible that this type of therapy can offer the same benefits previously~     established in other types of tissues, the stimulation of bone formation, neovascularization~     and the regeneration of peripheral nerves. Research groups have investigated the efficacy of~     LLLT for the treatment of spinal cord injuries and have demonstrated that laser therapy~     administered simultaneously to an injured sciatic nerve and corresponding segment of the~     spinal cord accelerates the regeneration process of the injured peripheral nerve.~   "
1988|NCT03031210|"~     The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is~     non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired~     pneumonia in children presenting at a paediatric Emergency Department (ED).~   "
1989|NCT03031197|"~     The small RCT will assess feasibility, acceptability, and impact of a real-time intervention~     on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a~     wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a~     personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when~     they miss a dose, and engage in monthly counseling sessions informed by their adherence~     data. Comparison subjects will receive usual care and an offer of counseling at monthly~     clinic visits.~   "
1990|NCT03031184|"~     This clinical trial evaluates whether Mirtazapine or Carbamazepine are more effective than~     placebo in treating agitation in people with dementia. The trial will assess the safety,~     clinical and cost effectiveness of each treatment. Participants will be randomised to~     receive one of the treatments for 12 weeks and will be followed up for up to one year, in~     this blinded trial.~   "
1991|NCT03031171|"~     The goal of the project is to increase colorectal cancer screening within the priority~     population of female and male adults age 50 to 85 in Northern Nevada. A successful~     community-based cancer patient navigator program will be modified in partnership with the~     community into a multi-level screening intervention.~   "
1992|NCT03031158|"~     Low back pain (LBP) is extremely common in older adults and is associated with a host of~     negative consequences, including decreased physical function and increased healthcare~     utilization. Among older adults with LBP, hip impairments indicative of hip joint disease~     are more prevalent and associated with greater disability than among older adults without~     LBP. This study will investigate a novel intervention designed to improve LBP-related~     disability by combining a typical spine-focused exercise program with a hip-focused~     intervention.~   "
1993|NCT03031145|"~     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation~     following nasal application of felis domesticus, or cat, extract in e-cigarette users,~     cigarette smokers, and non-smokers.~   "
1994|NCT03031132|"~     The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the~     consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein~     beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep~     quality in young adults.~   "
1995|NCT03031119|"~     Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for~     14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919~     co-administration at low and high doses on the PK of atorvastatin in a single cohort.~   "
1996|NCT03031106|"~     The aim of this study is to adjust and test an existing internet-based tool for collecting~     patient-reported outcome measures and to use the internet-based tool in an multidisciplinary~     follow-up of patients treated for malignant hematological diseases. The patient-reported~     outcome measurements will be used in describing the patients' health-related quality of life~     (HRQoL) and to investigate whether the HRQol will increase due to participation in~     multidisciplinary follow-up.~   "
1997|NCT03031093|"~     This study has the objective to clarify the factors that directly influence the~     effectiveness of inhaled drug deposition in obese patients with chronic obstructive~     pulmonary disease (COPD) and suggest the use of epap valve during their inhalation therapy.~   "
1999|NCT03031067|"~     One of the major challenge in the field of organ transplantation is the shortage of donor~     organs. Many patients waiting for organ transplantation die during the waiting time and many~     patients wait for organ transplantation many years with a detrimental effect on their~     quality of life, and increasing morbidity and the costs related to. Effective strategies,~     which safely extends the donor pool, are therefore advocated. During the last 20 years the~     two main policies to gain this purpose were the living donation and the utilization of~     extended donor's criteria (ECD). These donors are supposed to yield a lower outcome than the~     conventional donors and many research protocols were developed to reduce the preservation~     injury (PI) and PI-related complications. Static cold storage (SCS) has been the standard~     technique in clinical practice for liver and kidney preservation using particular solutions~     (Wisconsin, Custodiol and Celsior) able to prevent cellular swelling. Recently, graft~     preservation with hypothermic machine perfusion (HMP) is developing, because it seems to~     improve early graft function due to increased tissue ATP concentrations upon reperfusion and~     due to the continual flush of the microcirculation which removes waste products.~      The addition of oxygen during the perfusion represents an innovation in the methods of~     preservation in approved clinical setting seems to add further improvements of the graft.~     The present study was designed in order to assess the impact of hypothermic oxygenated~     perfusion (PIO) of marginal human kidney and liver compared with SCS.~   "
2000|NCT03031054|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. The hydrodissection~     could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic~     acid was proved to decrease adhension of soft tissue and nerve during operation. The~     investigators design a randomized, double-blind, controlled trial to assess the effect after~     ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.~   "
2001|NCT03031041|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. The hydrodissection~     could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection~     was pervasively used in clinical practice, current researches contain small participant~     without control group or randomized leading to foreseeable selection bias. The investigators~     design a randomized, double-blind, controlled trial to assess the effect of different method~     of ultrasound-guided hydrodissection in patients with CTS.~   "
2002|NCT03031028|"~     This study will consider the effectiveness of the ketogenic diet (high-fat,~     low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group~     of eligible epileptic children and adolescent who have been referred from epilepsy center to~     our clinic and prescribe them ketogenic diet.~   "
2003|NCT03031015|"~     To introduce a novel external-fixation technique using the combination of K-wires and~     cement. For comparison, we also included another group of patients who were treated using a~     mini plate and screw system. Bone healing, range of motion of the fingers, costs of~     treatments, and patient satisfaction were assessed.~   "
2004|NCT03031002|"~     Patients with anxiety disorders oftentimes express fear responses to more than only one~     fear-inducing object. The principal aim of this study is to examine whether the beneficial~     effects of exposure on fear reduction in spider phobia can extend to stimuli which are~     conceptually similar to spiders (i.e. cockroaches), but have never been presented during the~     respective treatment.~   "
2005|NCT03030989|"~     This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after~     hematopoietic stem cell transplant in prevention of central line associated blood stream~     infections. Half of the participants will use 2% CHG washcloths and other half will use~     placebo washcloths.~   "
2006|NCT03030976|"~     CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has~     been hailed for its promising remission rates after early stage clinical trials for acute~     lymphoblastic leukemia. However, CAR-T therapy is seldom used for autoimmune diseases.~     Researchers only use it for the treatment of multiple sclerosis (MS, an autoimmune disease~     of the central nervous system). SLE is a kind of autoimmune diseases which involving~     multiple systems, organs and with the present of a variety of autoantibodies. In the~     conventional treatment options, SLE could be treated with chemotherapy drugs or hormone~     drugs. But chemotherapy and hormone drugs could barely cured SLE. And now, chimeric antigen~     receptor modified T cell infusion maybe an effective treatment to solve these problems. The~     investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat~     patients with SLE. The purpose of this study is to assess the safety and efficacy of this~     2nd CAR-T cells in the treatment of SLE.~   "
2007|NCT03030963|"~     Ventilator mode change was associated with decrease in blood loss during posterior lumbar~     interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose~     of this study was to determine the effect of equal ratio ventilation (ERV), which sets the~     I:E ration of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood~     loss during PLIF. We hypothesized that ERV would decrease surgical blood loss due to~     decrease in the PIP~   "
2008|NCT03030950|"~     This study is designed to explore the effects of peri-neural dexmedetomidine on the duration~     and motor sparing potentials of adductor canal block in adult patients undergoing~     arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators~     ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps~     muscle strength to promote safe and early ambulation.~   "
2009|NCT03030937|"~     The purpose of this study is to determine whether apatinib plus irinotecan can improve~     progression free survival compared with single irinotecan in patients with advanced gastric~     cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.~   "
2010|NCT03030924|"~     This study is prospectively enrolling a cohort of adolescent patients who present to the~     Emergency Department with acute suicidality.~   "
2011|NCT03030911|"~     The aim of this study is to compare the effect of dexmedetomidine on resting energy~     expenditure in relation to the midazolam in critically ill patients using indirect~     calorimetry~   "
11984|NCT02900573|"~     Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical~     dilemmas among health care providers, despite clinical guidelines.~   "
2016|NCT03030807|"~     The investigation serves the identification of pulmonary hypertension (PH) among patients~     with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data~     from South America indicate that the prevalence of pre-capillary PH amongst patients with HP~     is higher than 20%. There are no reliable data from Europe so far. According to our previous~     analysis, more than 400 HP patients have participated in pulmonary rehabilitation at least~     once in the past 10 years at Klinikum Bad Gleichenberg (Rehabilitation Center for~     Agricultural Workers in Austria). This collective of patients is to be invited to~     participate in the study.~      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical~     suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the~     determination of the prevalence of PH in patients with HP we aim to assess the reliability~     of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.~   "
2017|NCT03030794|"~     This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS)~     on Gulf War illness related headaches and pain.~   "
2018|NCT03030781|"~     Specific and objective guidelines for choosing endobronchial tube size for main-stem~     intubation in pediatric patients are lacking. The objective criteria for choosing an ETT~     size for OLV are likely to increase the safety and success. The primary aims of this study~     were to define the relationship between cricoid and mainstem bronchi (right and left) in~     children of various ages and to determine the effects of age, height and weight.~   "
2019|NCT03030768|"~     The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial~     proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships.~     Such couples face a difficult dilemma when considering their desire to have children: forego~     condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and~     relinquish their childbearing desires. Based on evidence from rigorous clinical trials~     demonstrating the strong efficacy of individual interventions for HIV-1 prevention and~     formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1~     prevention and reproductive health in the Kenyan context, this study pilots a safer~     conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART]~     taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1~     uninfected partner) and timed condomless sex. Additional strategies for couples include~     diagnosis and treatment of STIs and male circumcision.~      mHealth tools, including SMS and mobile applications are novel and very popular among~     Kenyans to ease the burden of addressing health problems. This safer conception intervention~     incorporates mHealth tools to improve couples' experiences tracking fertility indicators and~     communicating with providers about their readiness to practice safer conception. SMS surveys~     to collect daily information from women about their fertility signs and SMS messages are~     used to reinforce HIV-1 prevention, including condom use for couples during periods that do~     not have a high likelihood of fertility. An in-clinic mobile application is used to improve~     clinician-patient counseling and assessments of couple readiness to practice safer~     conception. To inform future engagement of mHealth tools, the investigators will~     prospectively evaluate clinician and patient experiences using SMS surveys and the tablet~     application. Couples with immediate fertility intentions will be followed longitudinally,~     allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika,~     Kenya.~   "
2020|NCT03030755|"~     The goal of this research is to develop measurement tools and simulation technology for~     characterizing and predicting individual responses to corneal treatments and for advancing~     understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and~     are being evaluated for corneal crosslinking or 2) have refractive error and are being~     evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to~     assess their mechanical properties and will have computational simulations performed to~     predict the response to treatment. One aim of the study is to test the hypothesis that~     computational models can predict the cornea's shape changes within clinically acceptable~     limits of error.~   "
2021|NCT03030742|"~     This study seeks to investigate the prescribing patterns and patient utilization of opioid~     pain medication in the postpartum setting. Postpartum women will be surveyed prior to~     hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid~     tablets they used (in relation to the number prescribed), pain satisfaction, and~     storage/disposal of any remaining opioid tablets.~   "
2022|NCT03030729|"~     Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a~     commercial OCT (Optical Coherence Tomography)~   "
2023|NCT03030716|"~     Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral~     complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that~     adaptation to similar antinutritional factors is possible when consumed over time.~     Limitations in current studies include short (single meal) duration, and use of incongruent~     tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins~     does happen, it may be due to salivary proline-rich proteins, which have been found to be~     protective of iron status in animal models. The primary objectives of this study are: 1) To~     determine whether condensed tannins impact iron bioavailability or status when consumed in~     multi-dose, multiple daily supplements and 2) to test whether salivary protein production~     may impact iron bioavailability with tannin supplementation. Secondary objectives included~     assessment of the reliability of astringency as a measure of salivary protein production and~     iron absorption.~      The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old,~     to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95%~     proanthocyanidin rich grape seed extract before and after regular, three times daily~     supplementation for four weeks. Each participant consumed all three concentrations of~     supplement over the 26-week study, with a two-week washout between interventions. Direct~     iron absorption was measured using area under the curve. Iron status was measured by changes~     in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels.~     Salivary samples were collected before and after supplement consumption during meal~     challenges, and analyzed on HPLC. Astringency testing was conducted at the end of each meal~     challenge. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling~     followed by pairwise comparison by least significant differences. Pearson's correlations~     were used to correlated salivary proteins and astringency with iron bioavailability.~      The present study will provide important information regarding the approximate influence of~     condensed tannin consumption on iron bioavailability and storage over time, at different~     doses. Data will also help to delineate possible physiological mechanisms underlying tannin~     adaptation and possible ways to detect individuals who better adapt than others.~   "
2024|NCT03030703|"~     Phytic acid is a known inhibitor of iron bioavailability, although long term studies have~     suggested possibly exaggerated findings compared to single meal studies, pointing to phytic~     acid adaptation over time. Salivary proline-rich proteins have been found to reduce~     tannin-iron chelation, but studies have not explored changes in salivary proteins that may~     result in phytic acid adaptation. The primary objectives of this study are: 1) To determine~     whether phytic acid impacts iron bioavailability or status when consumed over time 2) to~     test whether salivary protein production may impact iron bioavailability with phytic acid~     supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary~     objectives included assessment of the reliability of astringency as a measure of salivary~     protein production and iron absorption.~      The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to~     determine iron bioavailability with supplementation of 350 mg phytic acid before and after~     regular, three times daily supplementation for four weeks. Direct iron absorption was~     measured using area under the curve. Iron status was measured by changes in hemoglobin and~     ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were~     collected before and after supplement consumption during meal challenges, and analyzed on~     HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In~     vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron~     absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by~     pairwise comparison by least significant differences. Pearson's correlations were used to~     correlated salivary proteins and astringency with iron bioavailability.~      The present study will provide important information regarding the approximate influence of~     phytic acid consumption on iron bioavailability and storage over time in regards to salivary~     proteins. It will also give context to the role of salivary proteins with phytic acid~     consumption over time. Data will also help to delineate possible physiological mechanisms~     underlying phytic acid adaptation and possible ways to detect individuals who better adapt~     than others.~   "
2025|NCT03030690|"~     This study will evaluate the clinical performance of glass carbomer cement restorations in~     restoring proximal lesions in primary molars compared to that of resin modified glass~     ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of~     the three restoration groups and the restorations will be evaluated clinically and~     radiographically every six months.~   "
2026|NCT03030677|"~     The investigators are trying to establish an easy technique for insertion of a catheter for~     continuous infusion while performing pectoral type 2 (serratus) block, as a post operative~     pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence~   "
2027|NCT03030664|"~     A randomized, multicenter, placebo-controlled, double blind study in two parallel groups~     testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938~     compared to placebo in increasing the number of spontaneous bowel movements in infants and~     children with functional constipation.~   "
2028|NCT03030651|"~     The purpose of this study is to develop and test Breastfeeding Education and Support~     Intervention for improving timely initiation and Exclusive Breastfeeding rate.~      Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the~     simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does~     not meet the international recommendation for exclusive breastfeeding (EBF) for the first~     six months of life. Community-based educational and support interventions provided~     prenatally and postnatally are effective in increasing BF rates. However, there is paucity~     of such information in Ethiopia.~   "
2029|NCT03030638|"~     This study aims to characterise the use of single-agent olodaterol and single-agent~     indacaterol, the only marketed LABAs authorised for COPD, but not for asthma, in clinical~     practice.~   "
2030|NCT03030625|"~     The aim of this study was to determine the efficacy and safety of the implementation of a~     program of  image-guided focal Intensification dose to intraprostatic dominant lesion  in~     men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)~     eligible to receive radiotherapy in the Department of Radiation Oncology of HUP within the~     established dose escalation protocol with intensity modulated image-guided radiotherapy~     (IMRT / IGRT).~   "
2031|NCT03030612|"~     The purpose of this Phase I/II study is to investigate the safety and tolerability (Phase I)~     and the efficacy/clinical benefits (Phase II, proof-of-concept) of ARGX-110 in combination~     with standard doses of azacytidine (AZA) in subjects with previously untreated acute myeloid~     leukemia (AML) or high risk myelodysplastic syndrome (MDS) who are eligible for AZA~     treatment.~   "
2032|NCT03030599|"~     This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the~     efficacy and safety of JZP-258.~   "
2033|NCT03030586|"~     The objective of the ADDIA clinical Proof-of-Performance study is to validate the~     performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease.~      ADDIA clinical study is a multi-centre, non-interventional, prospective,~     proof-of-performance study with only one visit.~      About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely~     patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD)~     and 200 control subjects (healthy as compared to their age).~        -  400 patients with Alzheimer's disease (AD),~        -  200 patients with non-Alzheimer's neurodegenerative diseases (NAD),~        -  200 controls (healthy as compared to their age).~   "
2034|NCT03030573|"~     The investigators developed a new surgical technique in order to reconstruct the bile duct~     with the round ligament~   "
2035|NCT03030560|"~     The purpose of this study is to evaluate the effect of intraoperative use of lidocaine~     intravenous infusion on the postoperative analgesic consumption after adult spine surgery.~   "
2036|NCT03030547|"~     To evaluate physical activity levels and factors associated with physical activity levels in~     adult patients with muscle diseases.~   "
2037|NCT03030534|"~     The purpose of this study is to adopt an operational research approach that seeks to design,~     develop and pilot-test the health-promotion lifestyle model that will enhance~     health-promoting behaviour and lifestyle modification of university staff in Nigeria. The~     following are the hypotheses of the study:~        1. There will be a significant difference in the pre and post intervention practices of~          health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN~          staff~        2. There will be significant association between the health promoting lifestyle behaviours~          (behavioural outcome) and health status of NOUN staff~        3. There will be a significant difference in the pre-and post-intervention health~          promoting lifestyle behaviours (behavioural outcome) of staff of NOUN~        4. There will be a significant difference in the pre-and post-intervention health status~          measure (specific health measurement indicators) of staff of NOUN~   "
2038|NCT03030521|"~     Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why~     some aortic dissection are limited in extent while other aortic dissection extend~     extensively. The investigators hypothesize that the medial layers are separated as a result~     of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis~     is ture, dilation is necessary to the development of aortic dissection. In this study, an in~     vitro experiment was performed to test whether dilation is essential to the development of~     aortic dissection.~      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart~     Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.~     Firstly, the dissected aortic wall is sampled for routine pathological examination.~     Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on~     the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly,~     the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and~     tissue sheet of the experimental group was bound by a band to restrict its dilation in the~     next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is~     performed. Fifthly, for the experimental group, the band is removed, and the syringe is~     filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is~     released and cut into several parts to show whether the inner and outer media layers are~     separated by the blue stain or the red stain.~   "
2224|NCT03028103|"~     This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to~     characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID~     continuously in 28-day cycles in both study parts.~   "
2039|NCT03030508|"~     At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer~     patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the~     effect is not good enough, the adverse reaction is serious, and the individual differences~     were significant. The present study shows that these problems are related to the differences~     in the exposure of capecitabine and its metabolites in different patients. The genetic~     biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly~     affect the expression of metabolic enzymes involved in capecitabine and control the~     concentration of capecitabine and its metabolites. However, these markers have been obtained~     through clinical trials in the United States, and their role in predicting the effectiveness~     or safety of capecitabine and its metabolites has not been validated in Chinese cancer~     patients.The study was based on a case study of patients with colorectal cancer in China,~     and capecitabine as the primary postoperative chemotherapy regimen to verify whether the~     available biomarkers can be used to predict the effectiveness and safety of capecitabine. To~     clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of~     its effect, so as to discover new biomarkers.~   "
2040|NCT03030495|"~     1. To compare the risk of atherosclerotic lesion progression and subsequent~          patient-oriented composite outcomes (all-cause mortality, any MI, or any~          Ischemia-driven repeat revascularization) between deferred lesions with or without over~          microvascular disease, defined as physiological classification~        2. To explore independent predictors of atherosclerotic lesion progression in deferred~          lesions based on fractional flow reserve-guided strategy and treated by contemporary~          medical treatment~   "
2041|NCT03030482|"~     Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its~     occurrence can be related to several causes, mainly dominated by invasive procedures.~      anxiety management is typically based on a combination of prevention, evaluation, and~     therapeutic agents. However, it appears important to develop adjuvant approaches. Touch~     massage is one of them and that has been evaluated in various medical conditions.~      The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill~     patients during potentially painful nursing procedures.~   "
2042|NCT03030469|"~     The goal of this research is to investigate the impact of changing opioid analgesic~     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in~     adult dentistry settings. We will change prescribing defaults for select short-acting opioid~     analgesics including immediate release oxycodone and hydrocodone as well as codeine and~     tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial~     of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this~     intervention on patient-level outcomes using 18 months of data (6 months pre-intervention~     and 12 months post-intervention).~   "
2043|NCT03030456|"~     This study is a randomized clinical trial that has as objective to evaluate the effects of~     training with a vibratory platform on body composition, muscular strength functional~     capacity, flexibility and biochemical profile on elderly women. It will be done in the city~     of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80~     years-old, within the municipal limits and nearby areas selected randomly by a brown~     envelope in which a note will be stating if they belong to the control or vibratory platform~     group, in which the participant will be receiving whole body vibrations on the platform. The~     recruiting will be done by the institution through e-mail or by public call.~      Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied,~     in order to evaluate if they don´t have counterindications for the vibratory platform. They~     will be evaluated in their general health, socio-economical status, and history of physical~     activity. Participants will have their doubts cleared about the study, and a written consent~     will be signed. Before the intervention with whole body vibrations, nutritional and physical~     activity aspects will be evaluated. The treatment period on the vibratory platform will be~     of 8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility,~     palmar prehension strength, metabolic basal load, and functional capacity measurements will~     be taken. Before and after every session on the vibratory platform, heart rate, respiratory~     rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The~     interventional procedure will be done with a vibratory platform (Power Plate®, model my7™,~     UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will~     last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training,~     and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee~     flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the~     amplitude of 2 mm.~      The study aims to contribute with reducing the body mass index and body fat percentage, to~     improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and~     flexibility, also obtaining better biochemical profiles after the training period.~   "
2044|NCT03030443|"~     This study will use semi-structured interviews with participants in a prospective cohort~     study to explore women's experiences of pain and preferences in pain management during first~     trimester surgical abortion to create a more patient centered experience. We will analyze~     two study cohorts of women undergoing first trimester surgical abortion: women choosing oral~     anesthesia and women choosing nitrous oxide.~   "
2045|NCT03030430|"~     The purpose of this study is to establish PK similarity in the treatment of BAT1706 and~     comparators.~   "
2046|NCT03030417|"~     Background:~      The new drug LMP744 damages DNA. This causes cell death. Researchers want to see if it can~     treat certain kinds of cancer. They want to understand how the drug works and how it affects~     the body.~      Objective:~      To test the safety of LMP744 and find out the dose of the drug that can be safely given to~     humans.~      Eligibility:~      Adults at least 18 years old who have metastatic solid tumors or lymphoma, which have~     progressed after other treatment.~      Design:~      Participants will be screened with:~        -  Vital signs taken~        -  Blood and urine tests~        -  Heart tests~        -  Scans or ultrasound~      Some participants will have a tumor sample taken 2 times. A small piece of tumor is removed~     by a small needle. A scan or ultrasound will guide the process.~      The study will be done in 28-day cycles.~      Each cycle, participants will get the study drug in a vein for 60 minutes once a day for 5~     days.~      For day 1 of cycle 1, participants will be admitted to the clinic and have blood and urine~     taken several times.~      At the beginning of each cycle, participants will have a clinic visit and repeat some~     screening tests. They will also do this twice in the middle of cycle 1 and once in the~     middle of cycle 2.~      After participants stop taking the study drug, they will be followed for 30 days. They may~     give blood samples. They will be contacted by phone to see how they are doing.~   "
2058|NCT03030261|"~     Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for~     multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT,~     the natural next step is to evaluate maintenance/continuation therapy following second ASCT.~      Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide,~     making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab~     may increase efficacy and also the durability of responses which is essential to improving~     outcomes following second ASCT.~   "
2047|NCT03030404|"~     Background:~      Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child.~     Researchers want to gather data about hereditary gastric cancers. They want to learn about~     changes these cause in the body and about the genes involved.~      Objective:~      -To gather data about hereditary gastric cancer.~      Eligibility:~        -  People at least 2 years old with personal or family history with a hereditary gastric~          cancer.~        -  People at least 2 years old with gene changes that lead to such cancer or a lesion that~          may be hereditary.~      Design:~        -  Participants will be screened in a separate protocol.~        -  Participants will have:~             -  Physical exam~             -  Medical history~             -  Blood tests~             -  Scans~             -  Photos of skin lesions and other findings~             -  Gynecology consultation for women~             -  Cheek swab (some participants)~        -  For some participants, their relatives will be asked to join the study.~        -  Some participants will be asked to allow the study to get stored tissue samples for~          relatives who have died.~        -  Some samples will be sent to outside labs. All personal data will be protected. Samples~          will be destroyed when the study ends.~        -  Participants will get the results of genetic testing.~        -  Participants who cannot come to the NIH clinic may just give a cheek swab and have~          genetic testing done.~        -  Some participants will be contacted for more testing.~   "
2048|NCT03030391|"~     Background:~      The new drug 18F-PF-06445974 has a little radioactivity. This can be seen by a positron~     emission tomography (PET) scan. The drug helps researchers see a protein, PDE4B, in the~     brain. Looking at PDE4B in the living brain might show how it is involved in psychiatric and~     neurological disorders. One part of the study will look at how the study drug is distributed~     in the brain. Another part will study how brain measures vary.~      Objectives:~      To measure the protein PDE4B in the brain. To test how a new radioactive chemical,~     18F-PF-06445974, is distributed in the body.~      Eligibility:~      Healthy adults ages 18 and older~      Design:~      Participants will have 1-3 visits over a year. Each will be 2-5 hours.~      Women will have a pregnancy test each time.~   "
2049|NCT03030378|"~     This phase I trial studies the side effects and best dose of pembrolizumab and recombinant~     interleukin-12 in treating patients with solid tumors. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Recombinant~     interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating~     white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12~     may work better in treating patients with solid tumors.~   "
2050|NCT03030365|"~     Despite the high prevalence of Alzheimer's disease (AD), its underlying mechanisms remain~     poorly understood. An emerging body of evidence supports disorientation as an early marker~     for AD-related neurodegeneration. In this study we intend to collect, coregister and analyze~     Positron Emission Tomography (PET) and , functional and structural magnetic resonance~     imaging (MRI, fMRI) data from AD-spectrum patients to establish orientation as core~     disturbance in AD.~   "
2051|NCT03030352|"~     The objectives of the How-to parenting program are 1) to improve optimal parenting style,~     and 2) to foster children mental health (i.e. decrease in internalized and externalized~     problems, and well-being). The investigators expect that parents assigned to experimental~     groups will show improvements in parenting over time (i.e improvements in parental~     affiliation, parental structure and parental attitude toward autonomy), whereas parents in~     control groups will not show such improvements (i.e., stable or declining parenting~     quality). The investigators also expect children of parents in experimental groups to~     experience improvements in child mental health (i.e., fewer internalized and externalized~     psychological problems and increased well-being), whereas children whose parents are on the~     wait list will not show improvements over time (i.e., stable or deteriorating mental health~     and well-being).~   "
2052|NCT03030339|"~     The goal of this study is to assess whether children 12-18 months of age who are exposed to~     multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above~     the tolerable upper intake level (UL), have higher total body vitamin A stores and~     biomarkers of excessive vitamin A status, compared to children 12-18 months of age who have~     adequate vitamin A intake.~   "
2053|NCT03030326|"~     Twenty patients with a history of treatment, within the past year, of both asthma and either~     depression or an anxiety disorder will be recruited for this study. Patients will be~     recruited from their doctors and from advertisements. The investigators will randomly assign~     patients to two groups, using a crossover design. One group will first receive three months~     with four biweekly sessions of heart rate variability biofeedback treatment, and then will~     be followed for three months with a daily symptom diary. The other group will first be~     followed for three months, and then given the three months of treatment. In both treatment~     and following procedures, patients will receive psychophysiological testing sessions at the~     beginning and end of the three month period. The investigators will assess symptoms of~     asthma, anxiety, and depression as well as pulmonary function and will measure heart rate~     (from electrodes on the wrists), respiration (through a belt around the waist), end tidal~     carbon dioxide (through a cannula in the nose).~   "
2054|NCT03030313|"~     Assess the feasibility of using remote respiration rate monitoring as a component of home~     care, how respiration rate data may be used in combination with other data to potentially~     improve response to symptoms, and to generate data to inform the endpoints and effect sizes~     of future studies.~   "
2055|NCT03030300|"~     To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in~     newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to~     the remission rate.~   "
2056|NCT03030287|"~     The purpose of this study is to test the efficacy and safety of an experimental drug,~     OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal~     antibody and was developed to target cancer stem cells. Based on preclinical studies, it is~     believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the~     productive growth of new blood vessels, which tumors need to grow and spread.~   "
2057|NCT03030274|"~     This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with~     HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved~     ejection fraction)~   "
2255|NCT03027700|"~     The goal of this study is to learn more about liver fibrosis and methods to detect it. We~     will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and~     without liver disease.~   "
2059|NCT03030248|"~     There is good evidence that randomizing C. difficile NAAT(+), toxin(-) patients to~     non-treatment represents an ethically tolerable risk-benefit, even in cancer patients and~     hematopoetic stem cell transplant (HSCT) recipients. Actually, detection of free toxin in~     the stool was the standard of care for the diagnosis of C. difficile infection (CDI) from~     1983 through 2010. Since then, NAAT became the standard diagnostic test for over 60% of US~     hospitals (National Healthcare Safety Network, unpublished data). However, there is growing~     evidence that symptomatic patients who are NAAT(+), toxin(-) have outcomes similar to~     patients who are NAAT(-), toxin(-); some of these outcomes include 30-day mortality, ICU~     admission, and hospital readmission triggered by C. difficile. Furthermore, the United~     Kingdom has successfully used a similar two step diagnostic algorithm with a confirmatory~     toxin EIA since 2012.~      The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-)~     patients may be particularly important in transplant recipients. The usual treatment~     prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While~     this drug has excellent activity against C. difficile and commonly suppresses its growth to~     non-detection, it does not eradicate carriage and its use results in marked and prolonged~     disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal~     microbiota disruption at the time of HSCT engraftment has been demonstrated to be an~     independent predictor (controlling for other markers of underlying disease) of overall and~     transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow~     suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin~     (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All~     these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile~     patients might have significant negative repercussions without a clear clinical benefit.~   "
2060|NCT03030235|"~     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared~     with placebo, on heart failure, disease specific biomarkers, symptoms, health status and~     quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure~     with preserved systolic function.~   "
2061|NCT03030222|"~     The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared~     with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients~     with type 2 diabetes and heart failure (reduced or preserved ejection fraction, ischemic or~     non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related~     clinical reasons.~   "
2062|NCT03030209|"~     Glucose homeostasis changes after distal pancreatectomy are not well understood. This study~     aim to identify the incidence of and risk factors for, a change in glucose homeostasis in~     patients who underwent distal pancreatic resection.~   "
2063|NCT03030196|"~     To determine the significance of systemic RANKL inhibition for male reproduction, conducting~     a clinical controlled randomized double blinded intervention study on infertile men, to~     investigating whether Denosumab (Prolia) can increase semen quality and to investigate what~     subgroup of infertile men that might benefit from treatment.~   "
2064|NCT03030183|"~     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with~     Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab.~     Patients will be treated with RA101495 for 12 weeks.~   "
2065|NCT03030170|"~     Despite an improvement regarding morbidity and mortality since 30 years, especially in~     expert centers, pancreatic surgery remains currently associated to a significant~     postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the~     main complication following surgery is the occurrence of postoperative pancreatic fistula~     (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a~     longer hospital stays. The main risk factors associated to the occurrence of pancreatic~     fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the~     caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence~     of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue.~     Currently, no formal recommendations concerning the optimal technical for closure of the~     distal stump in DP are available. In fact, manual closing by elective suturing or stapling~     of the main pancreatic duct give similar results. The use of a reinforcing stapling~     potentially represents a simple way to decrease the occurrence of pancreatic fistula and~     requires evaluation by a prospective randomized study.~   "
2066|NCT03030157|"~     Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy~     for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection,~     which is associated with costs of treatment and potential poor prognosis. Although several~     randomized controlled trial have shown that prophylactic intravesical chemotherapy could~     prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown.~     The investigators want to determine the efficiacy of single instillation versus long-term~     intravesical instillation of pirarubicin for bladder recurrence after radical~     nephrouretectomy for primary upper tract urothelial carcinoma.~   "
2067|NCT03030144|"~     The international literature emphasizes the vast benefits of the effective implementation of~     evidence based nursing recommendations in improving patient care processes and enhancing~     health outcomes. The key role of nurses in the prevention, treatment and care of~     incontinence is highlighted. Studies have shown that UI is a neglected nursing care problem~     in Austria e.g. regarding diagnosis and nursing interventions. Nursing recommendations may~     enhance the frequency of diagnosis, the use of nursing interventions as well as decrease the~     frequency of daily UI in nursing home residents. Beside that little is known about nursing~     recommendations implementation regarding urinary incontinence in the nursing home setting,~     especially in the Austrian context.~      The aim of this study is to measure the effectiveness of the implementation of evidence~     based nursing recommendations regarding UI in Austrian nursing homes.~   "
2068|NCT03030131|"~     Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall~     all-stage 5-year survival of approximately 17%. The primary treatment of early stage~     (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a~     better prognosis, the 5-year survival for patients treated with surgery alone remains low,~     ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing~     postoperative chemotherapy versus no chemotherapy have shown a significant overall survival~     benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II~     and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy~     improves survival and recently the analyses also based on individual patients data of 15~     randomized trials showed a significant benefit of preoperative chemotherapy on survival with~     the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also~     become accepted in many countries.~      Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an~     attractive therapeutic option in the early stage NSCLC, which may reactivate host immune~     responses and enable longterm tumor control.~   "
2069|NCT03030118|"~     This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial~     that is designed to test whether treating patients who are at risk for development of lupus~     with hydroxychloroquine can slow accumulation of disease features. Effects on clinical~     progression of symptoms, patient-reported outcomes and changes in the immune markers of~     response will be measured and toxicity of the treatment will be assessed. This trial is a~     first step in testing a prevention strategy for lupus.~   "
2070|NCT03030105|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to~     evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive~     impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and~     additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also~     be evaluated.~   "
2071|NCT03030092|"~     One group will receive today's standard rehabilitation program following hip fracture~     surgery. The intervention group will have maximal strength training incorporated in their~     program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over~     4 sets for leg press and abduction resistance exercise at 85% of maximal strength is carried~     out. Oxygen consumption of walking, muscle mass, strength, balance and bone density will be~     compared between the groups following the 8-week rehabilitation period.~   "
2072|NCT03030079|"~     The goal of this pilot study is to assess the effectiveness of an electrical stimulation~     therapy option for the treatment of chronic phantom limb pain in upper-limb amputees. This~     therapy has been previously used for sports and joint injuries and is marketed for~     relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,~     increased local blood circulation, and maintaining or increasing range of motion. The~     investigators would like to explore the idea that physically exercising the muscles of the~     residual limb and increasing blood flow to the site of amputation through the promotion of~     motor contraction using electrical stimulation decreases chronic phantom limb pain.~   "
2073|NCT03030066|"~     This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics~     (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132~     mutations.~   "
2074|NCT03030053|"~     A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy~     older adults will be conducted to determine the effect of a flavonoid-rich supplement on~     cognitive function, peripheral arterial health and brain mechanisms. It is predicted that~     chronic flavonoid supplementation will result in cognitive benefits and that these may be~     due to beneficial effects of flavonoids on vascular and brain function.~   "
2075|NCT03030040|"~     This study examines whether a mindfulness-based self-help book is effective at reducing~     healthcare workers' levels of stress and improving their wellbeing.~   "
2076|NCT03030027|"~     The purpose of the present study is to examine the effects of perspective-taking~     reappraisals on the well-being of adult-child dementia caregivers.~   "
2077|NCT03030014|"~     assess the effect of dental educational program on oral hygiene among institutionalized~     hearing impaired and mute children in Cairo, Egypt.~   "
2078|NCT03030001|"~     This is a single-arm, open-label, one center, dose escalation clinical study, to determine~     the safety and efficacy of infusion of autologous T cells engineered to express immune~     checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients~     with mesothelin positive, recurrent or refractory malignant tumors.~   "
2079|NCT03029988|"~     This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in~     subjects with known active liver metastasis from colorectal carcinoma by comparing~     previously acquired (within 30 days of tilmanocept injection) FDG PET images .~   "
2080|NCT03029975|"~     Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in~     cognitive function. It is not quite clear why this happens; however, it is known that the~     loss of muscle and strength can increase risk for physical and mental health risks and~     impair the ability of older people to remain physically independent. Weight lifting and~     proper nutrition, particularly eating high quality protein at the proper time and quantity,~     may help prevent these losses when a person gets older. To determine if regular beef~     consumption as part of a higher protein diet aids the muscle adaptive response to resistance~     training and improvements in cognition, seventy healthy individuals will be recruited to~     lift weights 3 times a week for 10 weeks. One group (n=36) will consume the Recommended~     Dietary Allowance (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume~     an amount twice the RDA (1.6g/kg/day), which is in agreement with recommendations from the~     American College of Sports Medicine. Participants will have their muscle strength tested and~     samples of blood and muscles will be collected before and after training to determine how~     the muscle adaptive response to resistance exercise is affected by higher protein intake. In~     addition, participants will undergo cognitive assessments at baseline and follow-up to~     determine the influence of improving muscle strength on attention and memory. Overall, the~     investigators proposed study will use sensitive methodology to determine if providing~     protein above the RDA and at optimal times during the day in combination with a weight~     lifting program can help make someone stronger and build larger muscles than someone~     consuming the RDA, as well as what processes may be responsible for helping the muscles to~     get bigger and stronger.~   "
2081|NCT03029962|"~     The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text~     messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB~     women ages 14-18 years, nation-wide. The guiding theoretical model is the~     Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is~     associated with increases in TPP behavior.~   "
2082|NCT03029949|"~     The purpose of this study is to examine the effectiveness of acceptance and commitment~     therapy with vestibular rehabilitation in addition to clinical management for chronic~     dizziness, in comparison with treatment-as-usual(TAU) which is self-treatment vestibular~     rehabilitation in addition to clinical management for chronic dizziness.~   "
2158|NCT03028961|"~     The purpose of the proposed research study is to evaluate whether bone marrow transplant~     patients prefer the Stanford letter advance care planning tool to the standard Advance~     directive.~      Completion of advance care planning prior to BMT is very important, but not often done. The~     investigators believe that the Stanford Letter will be preferred by patients and will allow~     them to feel more comfortable and share more of their wishes with family members and the~     medical team.~   "
2083|NCT03029936|"~     Obesity and asthma share changes that may begin in the fetal development phase. The~     endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory~     response different from the habitual Th2 profile of cytokines. In these obese patients,~     possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary~     ventilation significantly.~      Due to the importance of the diaphragm in pulmonary ventilation, this study will be~     performed to verify possible alteration in the excursion and diaphragmatic thickness of~     adolescents with endophenotype obesity-asthma. In parallel, the possible underlying~     etiopathogenic substrate of this endophenotype will be explored through the dosing of muscle~     enzymes and inflammatory cytokines and obesity hormones.~   "
2084|NCT03029923|"~     Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However,~     depression and smoking are highly co-morbid and depressed mood may interfere with cessation~     and independently predicts mortality. Thus, a single, integrated treatment for both smoking~     and depression could be highly effective in reducing post-acute coronary syndrome mortality.~     Behavioral Activation (BA) is a well established treatment for depression and has recently~     shown promise as a treatment for smoking cessation. The investigators systematically~     developed an intervention integrating gold standard smoking cessation counseling with~     existing BA based mood management techniques for post-ACS smokers; Behavioral Activation~     Treatment for Cardiac Smokers (BAT-CS).~      Objective: For this R56 the investigators will conduct a vanguard trial to pilot all~     methods, materials, and systems for the later fully powered BAT-CS vs. attention control~     trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12~     weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be~     offered the nicotine patch if medically safe.~   "
2085|NCT03029910|"~     The purpose of this study is to determine the effectiveness of eccentric exercise combined~     with vibration or cryotherapy in Achilles tendon pathology.~      The investigators hypothesis is that the combined eccentric exercise is better than the~     results presented by the exclusive eccentric exercise.~      This intervention differs from the classic studies in that we maintain the intensity~     throughout the treatment.~   "
2086|NCT03029897|"~     Adverse drug reactions are collected exhaustively during the experimental development phase~     of the drug, but the trial population is not representative. In post-marketing~     authorization, the use in the real life of medicines requires to specify the profile of~     adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of~     adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the~     multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was~     reported by physicians, none by patients, for approximately 7,800 patients treated with~     Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.~      The investigators propose a study measuring the impact of the deployment of e-reporting to~     patients in a population suffering from multiple sclerosis in initiation of first line drug~     therapy. The study design will be a randomized controlled trial. Twenty-four direct or~     indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without~     intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal~     neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5~     patients, a total of 180 patients will be included. The expected duration of this study is~     12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each~     patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire~     will be made by telephone call to each patient.~      The study is part of the pharmacovigilance system in place in France and aims to improve its~     efficiency by increasing declarations and therefore earlier detection of signals in order to~     prevent and minimize risks.~      The comparison of the two arms should make it possible to decide on the usefulness of~     national support for e-reporting, while respecting a good integration with the French~     pharmacovigilance system.~   "
2087|NCT03029884|"~     This study evaluates invasive deep brain stimulation (DBS) in the treatment of chronic~     neuropathic pain. Half of the participants will be assigned to a group with recording /~     stimulation to one pain-related circuit of the brain while the other half of participants~     will be assigned to recording / stimulation to a different pain-related circuit of the~     brain. Relief of pain symptoms with stimulation will be studied in both groups. It is~     hypothesized that neural signals will correlate with pain states and that DBS can disrupt~     these pain states in both groups.~   "
2088|NCT03029871|"~     The primary objective of this phase 1 trial is to determine the dose-dependent toxicity and~     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic gene therapy in~     combination with SBRT in medically inoperable stage I (T1b - T2a) NSCLC. To accomplish this~     objective, 9 subjects will be enrolled in the study. We hypothesize that the combined~     treatment will demonstrate acceptable toxicity, and that it will be feasible to quantify~     adenovirus-mediated HSV-1 TK gene expression in the lung by PET. This phase 1 trial will lay~     the foundation for a follow-up phase 2 trial designed to examine efficacy.~   "
2089|NCT03029858|"~     The study will investigate whether PD-L1 and other immuno-markers will be influenced by~     osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive~     advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers~     can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the~     time of PD due to osimertinib resistance.~   "
2090|NCT03029845|"~     The purpose of the study to evaluate the feasibility of using low dose propranolol for~     people with fibromyalgia.~   "
2091|NCT03029832|"~     This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to~     evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo~     and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma~     (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting~     and who are ineligible to receive cisplatin-based therapy.~   "
2092|NCT03029819|"~     The purpose of this study is to investigate text messaging as a way to enhance~     mindfulness-based treatment for smoking cessation.~   "
2093|NCT03029806|"~     The purpose of this study is to investigate the role dietary salt plays in epigenetic~     regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme~     Lysine-specific demethylase 1.~   "
2094|NCT03029793|"~     The purpose of this study is to determine whether combination of molecular and biomarkers~     with functional imaging can predict pathologic response and clinical outcomes in squamous~     esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant~     chemoradiotherapy and surgery~   "
2095|NCT03029780|"~     The purpose of this study is to evaluate safety and efficacy of different administration~     regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.~   "
2516|NCT03024268|"~     Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure~     caused iatrogenic arterial septal defect (iASD) and the functional changes after~     interventional iASD closure in a randomized setting.~   "
2096|NCT03029767|"~     Hypertension is the most common risk factor for development of stroke, congestive heart~     failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The~     prevalence of hypertension will increase by 2025 in most parts of the world including~     Ethiopia according to World Health Organization.~      Physical inactivity has been identified as a stronger predictor of chronic diseases such as~     hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health~     conditions, specific to hypertension; the benefits of exercise have been promoted by a~     number of organizations and agencies including World Health Organization.~      According to the knowledge of the investigator there are no research works in relation to~     aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia,~     and particularly in the area selected for the present research. Therefore the aim of this~     study is to assess the effect of aerobic and resistance exercises on selected~     anthropometric, biochemical and physiological variables among hypertensive patients in~     Hawassa University Referral Hospital.~   "
2097|NCT03029754|"~     The investigators wish to determine whether passive leg raise allows for easier peripheral~     vascular access in the pediatric population. The investigators hypothesize that pediatric~     anesthesiologists will have higher rates of successful intravenous catheterization in~     children where a passive leg raise is employed.~   "
2098|NCT03029741|"~     The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque~     psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin~     covered with silvery scales. It occurs when skin cells are replaced more quickly than usual.~     The seriousness of psoriasis varies greatly from person to person. For some people it is a~     minor irritation, but for others it can have a major impact on their quality of life. .~      The purpose of the study is to determine how much of AZD0284 is taken up by the body. The~     safety and tolerability of the drug will also be assessed. It is hoped that the study drug~     will improve the management of psoriasis.~   "
2099|NCT03029728|"~     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis~     of hereditary angioedema disease type 1 from plasma~   "
2100|NCT03029715|"~     Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous~     anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is~     still unclear which anaesthesia regimen is better for this group of patients. The present~     study was carried out to compare the use of inhalation anaesthesia technique using~     desflurane and TIVA using propofol and dexmedetomidine.~      Methods: This randomized controlled trial was carried out on 100 morbidly obese patients~     undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal~     groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received~     general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In~     inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in~     TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion.~     Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative~     nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and~     post-anaesthetic care unit (PACU) stay were studied for both groups.~   "
2101|NCT03029702|"~     Gestational diabetes (GDM) is a significant clinical and public health burden, affecting~     over 400,000 pregnant women in the United States each year. Without adequate treatment,~     women with GDM and their infants are at risk for substantial morbidity. Because of this,~     experts recommend treatment focused on normalization of hyperglycemia to improve outcomes.~     However, providers have limited capacity to predict which treatment will achieve glycemic~     goals. This results in a choice based on provider and patient preference and a trial and~     error approach, which can create delays in glycemic control within the short (8-10 weeks)~     window between diagnosis and delivery. Maternal and fetal morbidity may be related to a~     mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering~     agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%,~     insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as~     underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical~     outcomes supports the use of an individualized treatment approach. The overall goal of this~     project is to investigate an individualized treatment approach for GDM where treatment is~     based on each woman's GDM mechanism. The study will employ the same treatment in both arms,~     but choice of treatment will differ based on study arm (matched or unmatched to GDM~     mechanism).~   "
2102|NCT03029689|"~     The project presented here will be the first prospective, randomized evaluation of the~     effect of ART on the structure and function of the gut microbiome. This study provides a~     unique opportunity to understand the benefits of ART with high intestinal penetration on the~     gut microbiome. It is thus a key study to understand the bidirectional interactions between~     the microbiome and the host in people living with HIV/AIDS.~   "
2103|NCT03029676|"~     This study evaluates the influence of premedication on cognitive functions in patients~     undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of~     premedication are anxiolysis, analgesia and the reduction of perioperative risk among the~     patients with comorbidities. The patients will be randomly allocated to receive~     premedication either with opioid solely or with benzodiazepine combined with opioid. The~     anesthetic technique is standardized.~   "
2104|NCT03029663|"~     This is a prospective study enrolling consecutive patients who undergo transurethral~     resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure.~     Study end-points are incidence, severity and predictive factors of surgical complications.~     The study secondary aim is a validation of Clavien Dindo scoring system for reporting~     complication of TURBT.~   "
2105|NCT03029650|"~     The study to be performed will utilize already FDA-approved marketed products in healthy~     adults for the purpose to generate data for establishing rate of drug delivery of Transderm~     Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of~     individuals utilizing these types of products.~   "
2159|NCT03028948|"~     This clinical trial studies how well an interactive tailored website works in promoting sun~     protection and skin self-check behaviors in patients with stage 0-III melanoma. An~     internet-based program may help individuals to perform skin self-checks and engage in sun~     protection behaviors.~   "
2517|NCT03024255|"~     This study is being conducted to assess the safety and efficacy of 3 concentrations of~     BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary~     hyperhidrosis.~   "
2106|NCT03029637|"~     Tooth replacement is a significant issue in the World. Such replacement is considered~     important by patients to improve aesthetics, function and quality of life. Tooth replacement~     is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and~     cost-effective tooth replacement option that involves minimal tooth preparation and are~     secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth.~     Clinical reports of these prostheses at the University of Hong Kong shows some of the~     highest success rate and greatest longevity in the dental literature. However, a problem~     with this type of prosthesis in that it still needs some tooth preparation to accommodate~     the framework thickness of the bridge. In some patients with tooth wear, this may mean~     cutting through the enamel crown down into dentine which will weaken the tooth. In light of~     the tooth preparation some patients will refuse this treatment, in particular patients with~     dental drill phobias.~      The aim of this study is to investigate RBBs with tooth preparation and with no tooth~     preparation for the replacement of single missing teeth in a randomized controlled trial.~     However, a significant consequence of a no preparation RBB will mean that after cementation~     the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand~     high. This will take time for the patient's original occlusion to re-establish itself by the~     movement of the tooth supporting the bridge. Despite the success of supra-occluding~     restoration has been reported in some studies, currently neither no preparation nor~     supraoccluding dental bridges are the standard of care for general dental practitioners and~     have not been reported on as a clinical trial in the literature. Most symptoms reported for~     supraoccluding restorations were transient and are reversible. The findings of this research~     will have significant impact on the teaching and practice for clinical prosthodontics and~     patient care worldwide. Patients will have a dental prosthesis that requires no dental~     drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that~     should have greater longevity. More patients, in particular phobic patients will therefore~     seek treatment for tooth replacement with this conservative treatment option.~   "
2107|NCT03029624|"~     The study is a single arm, prospective study of the safety and effectiveness of the Valencia~     Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with~     refractory urgency urinary incontinence.~   "
2108|NCT03029611|"~     This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA)~     vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage~     III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is~     a protein found in the blood and tumor cells of most who have been diagnosed with ovarian~     cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from~     DNA may help the body build an effective immune response to kill tumor cells that express~     IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination~     chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube,~     or primary peritoneal cancer undergoing surgery.~   "
2109|NCT03029598|"~     This phase I/II trial studies how well pembrolizumab and carboplatin work in treating~     patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back or~     has not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as carboplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving pembrolizumab and carboplatin may work better in treating patients with ovarian,~     fallopian tube, or primary peritoneal cancer.~   "
2110|NCT03029585|"~     This study will evaluate NanoPac administered intraperitoneally (IP) immediately post-second~     cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in~     women with with platinum-sensitive recurrent ovarian cancer. The study will compare four~     concentrations of IP NanoPac (plus IV chemotherapy) with SOC IV chemotherapy alone.~   "
2111|NCT03029572|"~     An intervention study design in 90 obese patients will be used. Nutritional, metabolic and~     psychological status as well as gut microbiota will be evaluated before gastric bypass and 6~     months post surgery. During this period of 6 months, all patients will receive a specific~     diet according to recommendation with regard to bariatric surgery.~      Subjects will be than randomized in 2 sub-groups:~      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.~     patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids~     vitamin and mineral supplementation~   "
2112|NCT03029559|"~     Rehabilitation approaches introduce a stimulus to a motor system, with the goal to enhance~     motor function to patients. For example, exposure to brief and intermittent episodes of mild~     hypoxia has shown to strengthen synaptic pathways to respiratory and skeletal muscle motor~     neurons. In humans with spinal cord injury, exposure to intermittent hypoxia (IH) alone or~     in combination with rehabilitative strategies has shown enhanced motor function. Another~     strategy known as inspiratory threshold loading, which involves breathing against pressure~     threshold loads, results in improved inspiratory muscle strength. Although there is evidence~     supporting the use of IH alone or in combination with other rehabilitative strategies in~     improving motor function in humans, the impact of exposure to IH or IH with inspiratory~     threshold loading on inspiratory muscle function and ventilation in humans is unknown.~   "
2113|NCT03029546|"~     The investigator's main objective is to analyze the effects of a routine prenatal care~     screening tool (glucola test for gestational diabetes) on maternal inflammation through~     assessment of maternal circulatory biomarkers and blood pressure. Improving knowledge about~     routine prenatal care and how a variety of screening factors affect maternal physiology~     allows the investigators to be educated and informed when caring for mothers with medical~     co-morbidities.~        -  Determine if an acute glucose load (50g) is associated with an in-vivo and in-vitro~          increase in the concentration of Advanced Glycation End Products (AGEP's) that, in~          turn, can impact vascular endothelial reactivity and induce an acute increase in blood~          pressure. Previous studies generated in the investigators' laboratory showed that~          circulating soluble Receptor for Advanced Glycation End Products (sRAGE) and Tumor~          Necrosis Factor (TNF)-a (mediator of acute inflammation) are considered markers of the~          extent of maternal RAGE activation and/or systemic inflammation, respectively.~        -  Determine how an acute glucose load (50g) at the time of normal screening for~          gestational diabetes induces an acute increase in the level of sRAGE and TNF-a. If the~          investigators' hypothesis is confirmed, the investigators will have strong confirmation~          of the involvement of glycation products and TNF-a in generating the acute negative~          clinical symptoms of women experiencing a glucose tolerance test, such as headache,~          nausea, sweating, and bloating.~   "
2114|NCT03029533|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of~     DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients~     with prostate cancer~   "
2187|NCT03028584|"~     This is a two part observational study evaluating the feasibility of implementing an~     EHR-based model within a community oncology practice.~   "
2115|NCT03029520|"~     The aim of this study was to evaluate and compare postoperative pain and overextension of~     root canal filling after root canal treatment using a carrier-based obturation system and~     two different sealers.~      In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160~     patients were treated. Patients with vital and devital teeth were assigned to four groups~     using a randomized block design with block sizes of 10 patients each. The groups were~     composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth~     treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus~     sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator~     prepared root canals and filled them with sealer using the carrier-based obturation~     technique. Radiographs were taken and obturation length was recorded. Patients recorded pain~     scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6,~     6-12, 12-24, and 24-72 h..~   "
2116|NCT03029507|"~     The proposed study is a cohort-randomized controlled trial of Acceptance and Commitment~     Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for~     overweight or obese Navy personnel.~   "
2117|NCT03029494|"~     The objective of this study is to quantify salivary oxidative stress biomarkers in patients~     with temporomandibular disorders and to quantify recently isolated endogenous peptide~     opiorphin in saliva of these patients. As chronic exposure to stress may cause hyperalgesia~     as a result of the stress response in the hypothalamic-pituitary-adrenal axis, aim is to~     test this as an underlying mechanism by correlating opiorphin and oxidative stress markers~     to salivary cortisol levels. The aim is to assess the association of oxidative stress~     salivary biomarkers with muscle and joint pain and to measure opiorphin, a potential~     biomarker of different pathological states.~   "
2118|NCT03029481|"~     Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with~     relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy~     options. A large body of preclinical data supports a role for IGF-1R inhibition in the~     treatment of Ewing sarcoma.~      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-~     agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human~     monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded~     access IND to provide our patient the opportunity to benefit from this treatment after~     having developed progressive disease after multiple lines of prior therapy.~   "
2119|NCT03029468|"~     The primary aim of this study is to test the feasibility and acceptability of implementing a~     multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain~     symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40~     SCD patients with chronic pain or on chronic opioid pain treatment to receive 8 sessions of~     cCBT through our Web- and smartphone-based iCanCope with SCD program and weekly follow-up~     with a care coach. Participants will also use the iCanCope smartphone app to track daily~     pain intensity, pain interference and mood. The primary outcomes of the trial include~     feasibility (recruitment, retention, provider and patient feedback) and acceptability~     (sessions completed) of the iCanCope SCD program.~   "
2120|NCT03029455|"~     Evaluate the safety and tolerability of VX-659 in healthy subjects~   "
2121|NCT03029442|"~     The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent~     the loss of bone in participants legs due to SCI. This drug is FDA approved to treat~     osteoporosis in women after menopause who have an increased risk for fractures, to treat~     women receiving certain treatments for breast cancer who have an increased risk of~     fractures, and to treat bone loss in men receiving certain treatments for prostate cancer~     who have increased risk for fractures. This drug is considered experimental for the purpose~     of this study. Study participation will last for approximately 12 months (6 study visits~     total), visits will range from1-4.5 hours depending on the number of tests that need to be~     completed. The study is a double-blinded placebo trail in which the participant will be~     randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt~     solution injections.~   "
2122|NCT03029429|"~     Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have~     early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2~     clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in~     pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight~     loss, improve glucose tolerance and slow growth plate closure in children and young adults.~   "
2123|NCT03029416|"~     30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic~     outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the~     radiation oncologist) with respect to disease control and toxicity.~   "
2124|NCT03029403|"~     This is a phase 2 study whose purpose is to see whether the combination of of pembrolizumab,~     DPX-Survivac vaccine and low-dose cyclophosphamide has anti-tumor activity in patients with~     advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.~      DPX-Survivac is an investigational vaccine. A vaccine is a substance that is often given to~     stimulate the body's immune system (the structure and processes in the body that protects~     against harmful substances) to help prevent against certain diseases. DPX-Survivac is a~     vaccine that may teach the immune system to recognize cancer cells and to kill them.~      Pembrolizumab is a drug that is approved for the treatment of a certain type of melanoma (a~     type of skin cancer) and non-small cell lung cancer. Pembrolizumab blocks the function of a~     protein called programmed cell death receptor-1 (PD-1). PD-1 works by keeping the immune~     system from destroying cancer cells. Stopping PD-1 from working may help the immune system~     to fight cancer cells.~      Cyclophosphamide is chemotherapy drug that is approved for the treatment of various cancers~     alone and in combination with other drugs.~   "
2142|NCT03029169|"~     Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their~     presence and management are related to patient´s prognosis. 1c class antiarrhythmics are~     seldom administered in intensive care due to a dose dependent toxicity published in case~     reports and unfavourable outcome reported in a few prospective trials done on cardiology~     patients. The papers on 1c class antiarrhythmics do not take into consideration a complex~     haemodynamic assessment using echocardiography. The authors have recently presented a~     retrospective study on SV arrhythmias in septic shock patients demonstrating favourable~     effect and safety of propafenone which showed higher antiarrhythmic efficacy than~     amiodarone.~   "
2125|NCT03029390|"~     Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including~     impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher~     risk to develop type 2 diabetes mellitus (T2DM) in 10 years.~      The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has~     been demonstrated, the first line of pharmacology treatment is metformin, on the other hand,~     the traditional Chinese and Ayurverica medicine offer potential active substances for the~     treatment of hyperglucemia like berberine.~      Berberine is an extract with hypoglycemic effects in animal models as well as in clinical~     trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing~     it's activity against metformin in prediabetes would provide impact information on a new~     alternative treatment and compare with the standard pharmacological treatment.~      The aim of the study evaluate the effect of administration of berberine versus metaformine~     on glycemic control, insulin secretion and insulin sensitivity in patients with pre~     diabetes.~      The investigators hypothesis is that the administration of berberine versus metformin~     modifies glycemic control, insulin sensitivity and insulin secretion in patients with~     prediabetes.~   "
2126|NCT03029377|"~     The objective of this study is to measure sympathetic nervous system function and stress~     responses in patients with clinically documented and self-reported chronic fatigue that is~     worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and~     stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS)~     and who self-identify with stress induced worsening fatigue, will be compared to data from~     normal individuals pre and post-stress.~   "
2127|NCT03029364|"~     The ability to upregulate fat oxidation at appropriate times such as during fasting, low to~     moderate intensity exercise and after a high fat meal, is an important marker of health and~     a determinant of optimal endurance performance.~      Maximal fat oxidation reportedly occurs at an exercise intensity between 45 - 65% of maximal~     oxygen capacity with large between-subject variability apparent. Numerous factors have been~     associated with maximal fat oxidation, but a large amount of variance remains unexplained.~     Additionally, the within-subject variability of maximal fat oxidation has not been~     systematically evaluated, but may partially account for the reported between-subject~     variability and thus, only once measured can determinants of maximal fat oxidation be more~     precisely determined.~      The investigators want to further explore determinants of and investigate the within-subject~     variability of fat oxidation during exercise in a wide range of 'healthy' and 'at risk of~     metabolic disease' adults. By investigating these processes this work will explore how~     nutrition and exercise can be optimised to improve health and weight loss.~   "
2128|NCT03029351|"~     This is a prospective study to evaluate effect of Exenatide extended release treatment for 1~     year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to~     placebo.~   "
2129|NCT03029338|"~     In this single-center, open-label, no control, prospective clinical trial, a total of 10~     relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be~     enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused~     to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2.~     The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T~     cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.~   "
2130|NCT03029325|"~     Investigators use a genome-wide approach within a case-control design to identify SNPs that~     show evidence of association with lung cancer risk and survival.~   "
2131|NCT03029312|"~     Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak~     muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from~     muscle training that leads to secondary improvement in bone strength (osteogenic treatment).~     Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration~     Training (WBVT) improves mobility and also bone strength. No randomized controlled trials~     exist in OI children. This randomized controlled pilot study assesses the effect of 5 months~     WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children >5~     years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into~     a WBVT group and a control group matched by gender and pubertal stage. Main outcome measure~     is the change in tibial volumetric BMD, secondary outcomes include a variety of bone,~     mobility and dynamic muscle function variables.~   "
2132|NCT03029299|"~     BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed~     molecular-based in vitro diagnostic platform for infectious disease testing known as the~     FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the~     FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral~     microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)~     specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived~     classification by the FDA in October 2016 and is the first highly-multiplexed molecular test~     to receive this designation.~      The purpose of this study is to measure patient outcomes following implementation of the RP~     EZ test and to also gather data about physician office workflow and user interactions with~     the device. These data will be used to understand how the adoption of such tests may~     influence patient care in the CLIA-waived setting.~   "
2133|NCT03029286|"~     This trial will test a decision support web based intervention for women at increased risk~     for breast cancer due to breast density and other risk factors (age, race/ethnicity, family~     history of breast cancer, history of prior breast biopsies), and to consider MRI and/or~     chemoprevention to manage their breast cancer risk.~   "
2154|NCT03029013|"~     The study is the single arm and single center clinical trials，We conduct the phase II~     clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy~     sequential treatment with advanced recurrence of metastatic cervical cancer~   "
2155|NCT03029000|"~     A, multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen~     of 10 μg/kg of tbo-filgrastim administered sc daily on the mobilization of CD34+ cells in at~     least 60 healthy male and female donors. The pharmacokinetics, pharmacodynamics, safety,~     tolerability, and immunogenicity of tbo-filgrastim will be assessed .~   "
2636|NCT03022708|"~     This is a multi-center prospective, single-arm, non-randomized, open label study to assess~     feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right~     Ventricular Outflow Tract correction or reconstruction due to congenital heart~     malformations.~   "
2134|NCT03029273|"~     TCR-T cell therapy experienced a breakthrough for treating tumors in recent years. Phase I /~     II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma conducted by~     the Rosenberg team at the National Cancer Institute showed that 61% Synovial cell sarcoma~     and 55% melanoma had therapeutic responses. Another report of a phase I / II clinical trial~     for multiple myeloma showed that 20 patients received high affinity anti-NY-ESO-1 and LAGE-1~     specific TCR-T treatment, 16 of them (80%) had the average progression-free survival of 19.1~     months with minor side effect. These achievements indicate that TCR-T cell therapy can~     target a variety of tumors including solid tumors without any severe side effects found in~     CAR-T trials.~      This study is mainly focused on tumor testis antigen (Cancer-Testis Antigen), because it is~     not expressed in normal cells. NY-ESO-1 antigen is commonly expressed in 10-50% of melanoma,~     lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of~     multiple myeloma cases, and 70-80% of synovial cell sarcoma. Approximately 700,000 new cases~     of lung cancer are identified each year in China, 70% of them die within one to two years~     after diagnosis due to the lack of effective treatment. To address that unmet needs, our~     TCR-T treatment targets non-small cell lung cancer with NY-ESO-1 antigen expression.~      This study will investigate the safety and tolerability of TAEST16001 (TAEST: TCR Affinity~     Enhancing Specific T cell Therapy, autologous T cells transduced with affinity enhanced~     NY-ESO-1 TCR) cell therapy in subjects with NSCLC who have received prior therapy for their~     disease but their disease has progressed or relapsed.~   "
2135|NCT03029260|"~     This study aims to compare the effect of tension neural mobilization versus sliding neural~     mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain~     threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and~     the non-dominant lower limb (not subjected to mobilization) in healthy young participants.~   "
2136|NCT03029247|"~     This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD)~     subjects with anemia associated with chronic kidney disease (CKD), designed to compare the~     effects of daprodustat to epoetin alfa on blood pressure (BP).~      After a 4-week screening and a 4-week erythropoesis-stimulating agent (ESA) washout period,~     on Day 1 subjects will be randomized 1:1 and stratified by prior ESA dose before they~     undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the~     highest planned once-daily maintenance dose of daprodustat (24 milligrams [mg]) to the~     highest starting dose of epoetin alfa (100 international units [IU]/kilograms [kg]). This~     will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either~     daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance~     period, on Day 57 an Acute Challenge (number 2) will be repeated utilizing the same~     treatment as of Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after~     completing treatment. The total duration of subject involvement is up to 18 weeks (Screening~     to Follow-up).~   "
2137|NCT03029234|"~     The purpose of this study is to evaluate the safety, tolerability and overall response rate~     of carfilzomib in combination with dexamethasone for the treatment of multiple myeloma in~     China.~   "
2138|NCT03029221|"~     This project evaluates Real Relationships, a program provided by the Children's Aid Society~     (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible~     Fatherhood) program. Research questions focus on recruitment and retention of participants,~     and short- and long-term participant outcomes associated with different formats for offering~     the program.~   "
2139|NCT03029208|"~     The study will evaluate the safety and efficacy of daprodustat compared to rhEPO for~     treatment of anemia associated with CKD in subjects who are starting dialysis or who have~     recently started dialysis. Previous trial in dialysis subjects with anemia associated with~     CKD demonstrated that daprodustat could maintain hemoglobin up to 24 weeks with minimal~     effects on plasma erythropoietin (EPO) concentration. Daprodustat is postulated to be~     associated with fewer major adverse cardiovascular events by raising hemoglobin without the~     supraphysiologic EPO concentrations associated with intravenous (IV) rhEPO therapy,~     potentially avoiding blood pressure (BP) elevations and other adverse effects of high EPO~     levels. This randomized, open-label (sponsor blind) study will comprise three study periods:~     a screening period of 2 weeks (can be extended by an additional 4 weeks as needed), a~     52-week active treatment period, and a follow-up period of 4 to 6 weeks. Approximately 300~     subjects or 150 subjects per treatment group will be randomized 1:1 to receive daprodustat~     or rhEPO (darbepoetin alfa).~   "
2140|NCT03029195|"~     The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar~     molding (NAM) therapy has emerged in the management of CLP as an early presurgical~     intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to~     the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment~     of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of~     secondary surgeries. Despite that NAM therapy is becoming the treatment option for early~     cleft care, there is growing debate about its efficacy due to lack of quantitative~     assessment of these findings. To provide the highest levels of clinical evidence on NAM~     therapy, there has been international call for Randomized Controlled Clinical Trials.~      Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy~     for unilateral CLP.~      Aim of the study: is to develop a standardized non-invasive quantitative assessment for two~     different techniques of the NAM therapy in Egyptian infants that involves 3D laser~     scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis.~      Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The~     RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will~     be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry),~     and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM~     therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry~     that will be performed to age matched Egyptian norms).~      Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allocated to study~     groups (Group I, n=15) that will undergo NAM therapy before the primary surgical repair, and~     control group (n=15) that will undergo the primary surgical repair without NAM therapy. And~     15 Egyptian infants will act as norm group.~      Follow-up: (phase I- T0: before NAM, T1: after 1 month and T2: before surgery). (Phase II-~     T0: 10 days after surgery, and T1: 6 months after surgery).~   "
2141|NCT03029182|"~     The study will evaluate the utility of hypoxic exercise training to improve cardiovascular~     and metabolic health among obese breast cancer survivors. While participants exercise, a~     lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach~     removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity~     which is believed to support exercise tolerance. Participants are randomized to either the~     treatment (walking+simulated-altitude) or control (walking under normoxic conditions).~   "
2156|NCT03028987|"~     The purpose of this study is provide a better understanding of the adaptive immune response~     to the licensed flu vaccines. The investigators hope the information learned from this study~     will help identify and describe important factors of influenza immunity especially of or~     specific proteins associated with the T-cell immune response.~   "
2143|NCT03029156|"~     Background: The bronchodilator therapy is an essential component of the management of asthma~     exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is~     usually achieved through nebulization (creating small particles to be inhaled). The commonly~     used nebulizer device is a small volume jet nebulizer which has not been consistently~     reliable in delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA~     approved device which produces consistently respirable sized particles which could~     potentially result in better bronchodilator effect than the standard jet nebulizer.~      Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet~     nebulizer in delivering bronchodilators during a severe asthma exacerbation.~      Experimental design: Patients will be randomized (like a flip of a coin) to receive~     bronchodilator therapy as per the emergency room protocol either via small volume jet~     nebulizer or Aeroneb nebulizer.~      Subjects: Adult patients between age of 18 and 55 years who present to the emergency room~     with severe asthma exacerbation with peak expiratory flow rate <50% of predicted.~      Study procedure: When enrolled in the study and after randomization, we will then collect~     data that is standard for the hospital like heart rate, blood pressure and breathing indices~     and also some non-routine things like some scoring scales for shortness of breath and serial~     measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be~     more effective in delivering bronchodilator medication and thus more effective in managing~     asthma exacerbations.~   "
2144|NCT03029143|"~     The purpose of this study is to investigate the effect of vedolizumab intravenous (IV) dose~     optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen at~     Week 30 in participants with ulcerative colitis (UC) and high vedolizumab clearance, based~     on a Week 5 predefined serum vedolizumab concentration threshold (< 50 µg/mL) and who are~     Week 6 non-responders.~   "
2145|NCT03029130|"~     This study evaluates the use of extending time of continual urinary drainage (using~     transurethral foley catheter) for patients with early failures of vesicovaginal fistula~     repairs. Half of those included will be randomized to replacement of foley catheter for a~     length of 14 additional days, while the other half will be discharged (no intervention).~     Both groups will be examined for outcomes at 3 months post-repair.~   "
2146|NCT03029117|"~     It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females~     between corrected and uncorrected rheumatic valve lesions~   "
2147|NCT03029104|"~     This study will assess changes in visual acuity and corneal symmetry after corneal collagen~     cross-linking (CXL) of asymmetric corneas.~   "
2148|NCT03029091|"~     The purpose of this study is to test the safety and effectiveness of Losartan potassium in~     subjects with Eosinophilic Esophagitis (EoE), both those with a connective tissue disorder~     (CTD) and those without a CTD.~   "
2149|NCT03029078|"~     Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug~     Resistant (XDR) bacteria by performing a fecal transplantation.~   "
2150|NCT03029065|"~     This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and~     to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment~     efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring~     tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.~   "
2151|NCT03029052|"~     Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of~     patients. This risk may be linked with discontinuity of care between hospital physicians and~     Primary Care Physician (PCP). The investigators aim to assess in this study the impact of~     medication reconciliation at discharge associated with a patient's counseling session, both~     provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of~     medication reconciliation at discharge we expect a reduction by 15% of the number of~     prescription changes not maintained by the PCP after discharge.~   "
2152|NCT03029039|"~     Sepsis represents a serious public health issue characterized by a complex inflammatory~     response. In addition to their hemostatic role, platelets display inflammatory functions by~     secreting a variety of immunomodulatory factors and interacting with circulating immune~     cells. The investigators postulate that, in severe sepsis, platelets become activated and~     release amounts of different soluble inflammatory molecules that contribute to~     sepsis-associated inflammation. First, the investigators propose to assess whether severe~     sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful~     platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented~     infection, ICU patients with documented infection involving other bacterial species,~     compared to ICU patients with inflammation of noninfectious origin and healthy blood donors.~     Then, the investigators wish to assess whether the bacterial species affects the release of~     platelet sCD40L and by an extensive screening of platelet soluble factors, the investigators~     propose to set up profiles of inflammatory molecules associated with the type of infection.~     Finally, the investigators will analyze platelets' activation state and their association~     with circulating immune, according to the type of infection. Therefore, this project is~     expected to assess to which extent the platelet inflammatory function is super-activated in~     severe sepsis and to identify new platelet-related biomarkers of sepsis.~   "
2153|NCT03029026|"~     Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe~     AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic~     valve implantation (TAVI). Transthyretin amyloid (ATTR) deposits are common in the heart~     muscle in up to 25% of octogenarians, and after an asymptomatic period of unknown duration,~     cause overt heart failure and arrhythmias in a proportion of cases. The prevalence and~     impact of covert ATTR amyloidosis in elderly individuals with AS are unknown. Detection~     would avoid misdiagnosis, guide treatment and, potentially, improve outcomes. Recent data~     have shown that echocardiography, cardiovascular magnetic resonance (CMR), computed~     tomography (CT), and DPD scintigraphy, can identify ATTR amyloid deposits, but the clinical~     performance of these various tests is unknown.~      This study will investigate elderly patients with symptomatic severe AS using imaging to~     explore ATTR amyloid in AS and determine its prevalence and impact on outcome.~      The investigators aim to recruit a total of 250 patients aged 75 or older being considered~     for intervention for severe AS. The prevalence of cardiac amyloid will be assessed in three~     arms (sAVR, TAVI and medical therapy, with a likely patient ratio of 50:150:50), using five~     investigation modalities - all cohorts (echocardiography and DPD scintigraphy); sAVR cohort~     (biopsy and CMR); TAVI cohort (EqCT); medical therapy only cohort (as per work-up/trial~     prior to no intervention decision).~      The primary outcome measure is patient mortality. Secondary outcomes measures are major~     adverse cardiovascular events, length of stay, pacemaker implantation, ECV measured by EqCT~     and CMR.~      Follow up will be at 1-year with clinical echocardiogram (for sAVR and TAVI patients) and/or~     telephone interview for all patients (if not carried out in person at the time of the~     echocardiogram).~   "
2160|NCT03028935|"~     This randomized pilot clinical trial studies how well an evidence-based exercise and~     nutrition program adapted for Latinas will work in improving physical activity and dietary~     behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition~     program may reduce the risk for developing certain cancers, obesity, and chronic health~     conditions in Latinas who are non-active, overweight, or obese.~   "
2161|NCT03028922|"~     This clinical investigation is a prospective, multi-centre study to evaluate bone gain after~     horizontal augmentation using creos xenogain bone graft substitute. Patients included in the~     study are in need of a GBR procedure prior to implant placement in the premolar and~     posterior region of the mandible.~   "
2162|NCT03028909|"~     The purposes of this study are to determine if MEDI8852 administered with standard of care~     (oseltamivir) will reduce the time to normalization of respiratory function for adults who~     are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an~     acceptable safety profile in adults who are hospitalized with influenza caused by Type A~     strains.~   "
2163|NCT03028896|"~     The 90° rotation technique is known to improve the success rate of conventional LMA but its~     effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could~     increase the first attempt success rate of the insertion of LMA FlexibleTM compared to~     standard technique.~   "
2164|NCT03028883|"~     In this retrospective cohort study, we plan to examine the relationship between~     buprenorphine dose adjustments, gestational age, urine buprenorphine levels and the rate of~     neonatal abstinence syndrome in opioid-maintained pregnant women~   "
2165|NCT03028870|"~     The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily~     compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.~   "
2166|NCT03028857|"~     The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to~     pregnant women improves early brain development with improved brain-related development~     during the first four years of life. Participating pregnant women will receive either~     phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The~     primary outcome is the child's behavior at four years of age as reported by the primary~     caregiver. Secondary outcomes include motor development, socio-emotional development,~     language development, and cognitive development. Potential contributors beyond the~     supplement, including maternal stress and placental function will also be assessed.~   "
2167|NCT03028844|"~     Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and~     sucrose versus sucrose on stress~   "
2168|NCT03028831|"~     Alaska native people (AN) have the highest recorded incidence and death rate from colon~     cancer in the world (>90:100,000). We hypothesize that the AN, despite their high~     consumption of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of~     colon cancer because of colonic butyrate deficiency resulting from their remarkably low~     consumption of fiber-containing foods. We hypothesize that fiber supplementation of their~     usual diet will result in a bloom of butyrate producing microbes in the colon, resulting in~     increased butyrate production, which will suppress their high microbial secondary bile acid~     production, antagonize the actions of other food (smoked fish) and environmental carcinogens~     (tobacco, alcohol), and interact with the high circulating levels of n-3 fish oils to~     suppress colonic inflammation and cancer risk. In order to investigate this, we will conduct~     a randomized double-blinded 4-week clinical trial in up to 100 randomizable healthy,~     middle-aged AN undergoing screening colonoscopy, with the objective of obtaining 60~     completed interventions. The interventions will consist of either a high-dose soluble fiber~     supplement given as a drink, together with their usual diet which currently contains about~     15g total fiber/d, or to a control digestible starch drink plus their usual diet. The~     primary endpoint will be a clinically significant reduction in Ki67 proliferative colonic~     mucosal biomarkers of cancer risk. Microbiome and metabolome mechanisms responsible for the~     anticipated changes in mucosal biomarkers will also be investigated. Our results in extreme~     risk AN will be further evaluated by comparison to similar measurements previously made in~     minimal risk rural Africans and intermediate risk African Americans. Our results will be~     used to provide the scientific basis for a definitive large-scale high-fiber supplementation~     study (to achieve >50g total fiber/d) to suppress adenomatous polyp recurrence following~     colonoscopy.~   "
2169|NCT03028818|"~     To inform the feasibility of conducting a study to test different temperature thresholds at~     which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in~     critically ill children with fever due to infection.~   "
2170|NCT03028805|"~     This is a fully automated randomized trial with two randomization branch-points. The first~     is inclusion of disease-specific orders in the admission orders based on a predictive model~     using real-time data. The second is the use of dynamic orders that are end-user tested~     rather than static orders designed by a committee. The primary hypothesis is that automatic~     inclusion of disease specific orders with admission orders will improve adherence to~     guidelines for patients with COPD. The secondary hypothesis is that clinical and operational~     outcomes will improve, thereby improving value.~   "
2171|NCT03028792|"~     This study aims to test the efficacy and feasibility of administering a computerized~     attention training program targeting clinical levels of anxiety in Latino youth between the~     ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will~     be randomized to receive either 1) a 12-session attention modification program (AMP) or 2)~     an attention condition program (non-active treatment). Clinical assessment of symptom~     severity will be conducted before, during, and after treatment. We hypothesize that at the~     end of treatment, children who receive the active intervention (AMP) will show (1) decreased~     attention bias to anxiety-related triggers using an independent measure of attention bias to~     assess change and (b) reduced anxiety severity. We also hypothesize that this study will be~     feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This~     study is an initial step towards demonstrating the feasibility of implementing a novel~     computerized attention training program in anxiety in underserved community samples.~   "
2172|NCT03028779|"~     Implementation of Fast-track surgery for total hip replacement and total knee replacement~     and evaluation of the risks and benefits for the patients.~   "
2173|NCT03028766|"~     This trial is to determine what dose of a drug called AZD1775 can safely be given in~     combination with cisplatin before surgery and with chemo-radiotherapy after surgery in~     patients with Head and Neck Cancer. The Investigators will also get some preliminary~     information regarding the effectiveness of this combined treatment.~   "
2188|NCT03028571|"~     The investigators will test the null hypothesis that there will be no changes in the~     insulin-mediated suppression of endogenous glucose production (EGP) in response to autonomic~     blockade. To test this hypothesis, the investigators propose to determine the role of the~     autonomic nervous system in hepatic insulin resistance.~   "
2174|NCT03028753|"~     The investigators are trying to determine if using a bladder scanner (type of ultrasound) to~     check how much urine is left in the bladder is the same as checking that volume with a~     catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery,~     the investigators perform a voiding trial. Water is put into the participant's bladder~     through the catheter (tube draining your bladder). The catheter is then removed and the~     participant is asked to empty their bladder. After that, the investigators will use the~     bladder scanner (ultrasound) to see how much urine is left in the participant's bladder.~     After the ultrasound, the investigators will pass a very small catheter (tube) into the~     bladder to take out the remaining urine. The investigators will then compare the amount~     obtained from the catheter to the ultrasound amount. This will also help the investigators~     to figure out if they need to check how much urine is left in a patient's bladder after the~     voiding trial.~   "
2175|NCT03028740|"~     The STELLARIS study will be conducted to confirm the efficacy and safety of cenicriviroc~     (CVC) for the treatment of liver fibrosis in adult subjects with NASH.~   "
2176|NCT03028727|"~     Laser therapy has been proposed as a novel treatment option in controlling subgingival~     microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm~     diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic~     periodontitis (CP).~   "
2177|NCT03028714|"~     Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in~     adulthood and are prevalent in many university students. Increasing the knowledge about~     healthy nutrition and physical activity can positively impact students' lifestyle and~     prevent weight gain. This study aims to investigate the impact of online educational methods~     on nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university~     students in the UK. Anthropometric measurements will be assessed and questionnaires will be~     completed at the beginning and at the end of the study. Written consent will be sought, the~     voluntary nature of participation will be emphasized while anonymity and confidentiality~     will be strictly maintained.~   "
2178|NCT03028701|"~     The overall objective is to asses the bronchodilator effect of single dose of~     Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with~     COPD.~      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different~     times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2~     hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).~   "
2179|NCT03028688|"~     Millions of patients undergo upper GI endoscopy in the United States each year. A large~     number of these patients have anesthesia to assist with their comfort during the procedure.~     The majority of patients do not have a protected airway during the procedure, meaning there~     is no endotracheal tube. Instead the current standard of care is to give supplementary~     oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia~     there is a risk for low oxygen saturation during the procedure, which presents a significant~     patient safety issue. The purpose of the clinical trial is compare the current anesthesia~     standard of care against high flow nasal cannula oxygen delivery during anesthesia. The~     investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the~     frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.~   "
2180|NCT03028675|"~     Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for~     this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical~     Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a~     1-hour brain scan for both patients and controls. In the first 6 months of the study,~     investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement~     and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air~     and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia~     MRI, pH-weighted imaging will be validated for its robustness and reproducibility.~   "
2181|NCT03028662|"~     This is an experimental study in which the efficacy of three psychophysiological~     intervention modalities based on retrieval-extinction procedures is analyzed.~   "
2182|NCT03028649|"~     The purpose of this study was to verify the effect of 12-week with~     β-hydroxy-β-methylbutyrate (HMB) and a placebo (PLA) supplementation on body composition,~     anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood~     markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover~     trial.~   "
2183|NCT03028636|"~     A prospective, open label post market registry to collect Patient Reported Outcomes in an~     online data capture registry, maintained by Pelvalon, of women with fecal incontinence~     exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel~     control.~   "
2184|NCT03028623|"~     The objective of this study is to evaluate the feasibility and safety of salpingectomy~     versus standard tubal ligation in women undergoing surgical sterilization at the time of a~     planned cesarean delivery. Salpingectomy is currently being investigated as a potential~     strategy for ovarian cancer prevention. While this procedure is currently performed during~     hysterectomies, its feasibility at the time of cesarean delivery is not well established.~      This randomized, prospective clinical trial will compare the two sterilization methods to~     demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean~     delivery will not result in increased operative time, blood loss or other complications.~     This study is necessary to promote salpingectomy as a standard sterilization method during~     cesarean deliveries.~   "
2185|NCT03028610|"~     Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate~     pregnancies following the Acessa™ treatment of uterine myomas in women who desire future~     childbearing~   "
2186|NCT03028597|"~     The objective of this study is to reduce the effects of stereotype threat on the adherence~     of African American patients with hypertension.~      The specific aims of this study, which employs a values affirmation intervention, are to:~        1. Compare the effects of the values-affirmation exercise to a control condition on~          antihypertensive medication adherence in African American patients with uncontrolled~          hypertension across three clinical settings,~        2. Compare the effects of the values-affirmation exercise on antihypertensive medication~          adherence in African American patients and white patients with uncontrolled~          hypertension and similar socioeconomic characteristics, and~        3. Evaluate the intervention for widespread dissemination using the RE-AIM (reach,~          effectiveness, adoption, implementation and maintenance) framework~   "
2189|NCT03028558|"~     Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize~     nicotine and other flavor constituents. Despite the increasing use of EC, little attention~     has been paid to their possible adverse effects on human health. Theoretically, the risk~     relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The~     hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the~     oral epithelium, the first cell population exposed to inhaled EC vapors. Using a~     cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and~     ethnicity-matched never smokers, the investigators propose to assess the oral epithelium~     obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC~     study cohort will be restricted to young adults (age 21-35 yr) with no prior history of~     tobacco smoking, but who have smoked EC for >6 months.~   "
2190|NCT03028545|"~     In the recent context of deinstitutionalization and longitudinal studies pointing to a large~     number of positive long-term outcommes for people affected by a psychiatric disorder~     (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the~     possibility of overcoming the consequences of a psychiatric pathology emerges as a solid~     fact. Therefore, the existence of this possibility calls for the identification of the~     determinants underlying of the various outcomes over time of those affected by a severe~     psychiatric disorder, in particular those likely to underpin the most positive developments.~      While it is well known from a medical point of view that certain dimensions affect the~     prognosis of persons affected by a severe psychiatric disorder (such as the persistence of~     negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a~     purely medical perspective (and putting aside the role of the person and his environment)~     seems to be able to account only for a modest proportion of the prognosis of people affected~     by a serious psychiatric disorder.~      It is this fact that has gradually led to the emergence of complementary models capable of~     enriching the understanding of the determinants of the future of people affected by a severe~     psychiatric disorder, in particular models inviting to separate becoming of the person~     from the  psychiatric disorder to take into account the personal role of the person in~     his or her own healing. This perspective is the recovery perspective.~      Recovery process is defined as a personal trajectory which includes the person's experiences~     and the reactions of his / her environment following the installation of a psychiatric~     disorder, which can support a mode of release of the status of psychiatric patient.~     Recovery thus implies an approach underpinned by the understanding of the human response to~     pathology (Noiseux) and, one might add, of its environment.~      This definition of recovery is also subjective because it is tied to very personal~     experiences and related to the person's own norms as to what it means to be~     re-established. The subject engages in a long, progressive process, without return to the~     previous state. In a dynamic response to an equilibrium perturbed by the disease, we are~     interested in restoring a new equilibrium rather than the factor triggering its loss.~     Recovery is seen as a trajectory punctuated by decisive moments on a background of~     progressive change, this process oscillates between awareness, ambivalence and forward~     shift.~      However, while these studies point to a number of crucial dimensions involved in the~     recovery of a severe psychiatric disorder, one of the important limitations of these studies~     is the distance from any psychopathological consideration, thus setting aside the~     possibility of specific processes of recovery depending of the pathology. The identification~     of recurrent experiential logics specific to the various psychiatric disorders therefore~     appears to be an important field of investigation. It would potentially be able to guide the~     development of new therapeutic devices based on the recovery model.~   "
2191|NCT03028532|"~     Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often~     used by men in an off-label setting to both treat male infertility and in a multitude of~     sports disciplines to increase performance.~      Study Objectives:~        -  Determine detection windows for clomiphene and its metabolites in urine following a~          medium-term administration~        -  Understand the effect of clomiphene administration on luteinizing hormone (LH),~          follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a~          longitudinal manner~        -  Identify changes in current steroidal module of Athlete Biological Passport~   "
2192|NCT03028519|"~     This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of~     diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D~     receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin~     D repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity~     in these patients.~   "
2193|NCT03028506|"~     The purpose of the proposed study is to assess the distribution of carbohydrates and fat in~     the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at~     the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The~     carbohydrate distribution and fat content of the meal will be compared to maternal glucose~     control, preprandial glucose levels, and the percentile for weight of the infant at birth.~     In addition, each meal and snack will be classified as low-moderate fat or high fat.~   "
2194|NCT03028493|"~     This study serves to test a previously evaluated falls prevention intervention recommended~     by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in~     the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the~     intervention is accessible to older adults with low vision receiving services from the~     Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version~     of the SAFE intervention that has been adapted to be accessible for individuals with low~     vision at SBRC.~   "
2195|NCT03028480|"~     This study is a special drug use investigation program of NUCALA (a brand name for~     Mepolizumab) administered subcutaneously (SC). In this study the information regarding the~     safety and effectiveness of long term use of NUCALA after subcutaneous injection will be~     collected from Asthma subjects in daily clinical practice. The observation period per~     subject will be 52 weeks from the initiation of NUCALA treatment with follow-up~     investigation for 2 years after the observation period. NUCALA is a registered trademark of~     the GlaxoSmithKline [GSK] group of companies~   "
2196|NCT03028467|"~     This is a randomized, double-blind, parallel group, 3 dosage level, placebo-controlled,~     Phase 1/2 study designed to evaluate the pharmacokinetics, safety, tolerability, and~     efficacy of the monoclonal antibody GSK3196165, in Japanese subjects with active~     moderate-severe rheumatoid arthritis (RA) despite treatment with methotrexate(MTX). The~     subjects will receive GSK3196165 in combination with methotrexate therapy for the 12 weeks~     of treatment period. Approximately 55 subjects will be screened to achieve 40 randomized~     subjects, so as to have approximately 10 subjects in each treatment group.~   "
2197|NCT03028454|"~     The objective of the study is to determine whether five days of ginger (Zingiber officinale)~     supplementation is effective at reducing muscle soreness and improving muscle function~     following downhill running. Long-distance running is often associated with acute muscle~     pain, swelling, and reduced muscle functioning, and consequently, many runners utilize~     non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal~     side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and~     symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is~     Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from~     osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is~     effective at reducing general pain and muscle soreness. Therefore, this study will~     supplement 60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior~     to, the day of, and 2 days after downhill running. Participants will be evaluated for muscle~     soreness and function before and after the downhill run.~   "
2198|NCT03028441|"~     This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose~     comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage~     levels and 3 immunization schedules will be evaluated. This study will enroll up to 180~     healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject~     participation duration is approximately 8-13 months. The primary objectives are to evaluate~     the safety and tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo~     following two consecutive intramuscular injections and to assess the CHIKV serum plaque~     reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5~     TCID50 of MV-CHIK or placebo on day 29 following the first dose.~   "
2199|NCT03028428|"~     In this study, researchers want to determine the safety of MSCs that a patient can tolerate~     without causing side effects. Moreover researchers will also be looking at the function of~     the knee over time, which may give them some insight on the usefulness of MSCs as a~     treatment option.~   "
2200|NCT03028415|"~     To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in~     a population indicated for single, double, or triple hindfoot arthrodesis or ankle~     arthrodesis surgery with supplemental graft material.~   "
2201|NCT03028402|"~     This study aims to determine to what extent patient-specific factors, iatrogenic factors,~     and biomechanical factors influence cervical spine mechanics after single-level and~     two-level arthrodesis.~   "
2202|NCT03028389|"~     To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the~     incidence of delirium in elderly patients after non-cardiac surgery.~   "
2203|NCT03028376|"~     The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and~     GFAP measurements in prediction of need for neurosurgical observation and/or intervention in~     moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will~     benefit from neuro surgical expertise in specialized departments and thereby possibly better~     patient outcome. Hopefully also minimize treatment delay, secure optimal resource~     consumption and streamline patient courses by predicting the presence of neurotrauma.~      Hypotheses:~        1. A prehospital serum S100B level > 10 microgram g/L and expectedly above a certain and~          currently unknown cut-off value indicates the need for neurosurgical observation and/or~          intervention in moderate TBI patients.~        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can~          significantly predict a need for urgent neurosurgical observation and/or intervention~          in moderate TBI patients.~        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and~          GFAP can significantly predict a need for urgent neurosurgical observation and/or~          intervention.~        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and~          GFAP can significantly predict hospital course and outcome of patients with moderate~          TBI.~   "
2204|NCT03028363|"~     The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil~     Gel compared to vehicle in patients with acne vulgaris~   "
2205|NCT03028350|"~     The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for~     the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that~     involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other~     nonsteroidal anti-inflammatory drugs.~   "
2206|NCT03028337|"~     The goal of this clinical research study is to learn whether delivering spine radiosurgery~     in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.~      Researchers also want to learn about the effects of a single dose on participant's symptoms,~     pain, and quality-of-life.~   "
2207|NCT03028324|"~     The purpose of this study is to assess the influence of transcranial magnetic stimulation~     (TMS) on speech performance in individuals with primary progressive apraxia of speech.~   "
2208|NCT03028311|"~     The goal of this clinical research study is to learn about the safety of giving SIR-Spheres~     treatment to patients with liver cancer in the same session rather than over 2 sessions,~     which is the standard of care.~   "
2209|NCT03028298|"~     Each year, approximately 30,000 people in the United States suffer an intra-cranial~     hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will~     go on to have further neurological injury secondary to stroke (delayed cerebral ischemia)~     caused by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that~     the medication sildenafil, given intravenously, improves vasospasm, but has an associated~     degree of hypotension. The degree of hypotension was well within safety thresholds for these~     patients.~      Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V).~     The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does~     not result in as much hypotension. Specifically, the investigators look to show that~     comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an~     intravenous dose while the degree of hypotension is reduced. Additionally, using~     measurements of cerebral blood flow regulation acquired using transcranial Doppler~     ultrasound, the investigators look to show that oral sildenafil produces the same degree of~     improvement in vasospasm and blood flow regulation.~   "
2210|NCT03028285|"~     Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its~     effects include vasodilation, protection of inner layer of blood vessels and improvement of~     blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability~     of Unifusol infusions in healthy volunteers.~   "
2211|NCT03028272|"~     The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical~     and functional outcomes as fascia when used for tympanoplasties while offering benefits~     including reduced operative time, better patient satisfaction, and fewer complications.~   "
2212|NCT03028259|"~     A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected~     prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,~     typically up to 1 week after deliver) will be conducted. These women are of any age and all~     ethnic backgrounds delivering at St. Mary's Health Center.~   "
2213|NCT03028246|"~     The goal of this prospective, non-randomized, single-arm, feasibility study is to develop~     data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign~     intracranial tumors which require clinical intervention in pediatric and young adult~     subjects.~      Indication of Use: Ablation of benign intracranial tumors in children and young adults which~     are ExAblate accessible.~   "
2214|NCT03028233|"~     The study will test the impact of a community health worker (CHW)-delivered intervention~     aimed at helping families overcome barriers to childhood obesity prevention. Barriers~     include social, environmental, and family issues.~      This intervention will be compared to a control condition consisting of a community health~     worker (CHW)-delivered intervention aimed at helping families improve positive parenting~     skills.~   "
2215|NCT03028220|"~     Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes~     complications and self monitoring of glucose levels is an important component of achieving~     and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall~     glucose control in all age groups when used continuously, and reduces the incidence of low~     blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of~     the commonest metabolic complications of type 1 diabetes and, if it occurs frequently,~     people can become less aware of it. This reduced aware of hypoglycaemia has significant~     risks including seizures, coma and even death, and has an impact on people's ability to~     drive and function.~      The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of~     retrospective continuous glucose monitoring data to users when the monitor is waved in~     proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for~     14 days and is non-adjunctive (does not require calibration to capillary blood glucose).~      This clinical study proposes to assess the impact of Libre on frequency, duration and~     severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people~     with impaired awareness of hypoglycaemia.~   "
2216|NCT03028207|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality~     worldwide and hence, estimating its prevalence is important. Since 2007, there are few data~     on the prevalence of COPD in the general population in Spain. The main objective of this~     epidemiological observational study is to estimate the prevalence of COPD in residents of~     Spain among the population over 40 years of age. The subjects will be distributed in two~     groups depending on the presence and absence of COPD. The study will have a single visit in~     which a brief interview will take place and subjects will need to complete the medical tests~     the case report form with a series of questionnaires. No drugs will be administered in this~     study.~   "
2217|NCT03028194|"~     Use of Postpartum uterine curettage in reducing hospitalization time or in improving the~     clinical evolution of the patient with preeclampsia/eclampsia.~   "
2218|NCT03028181|"~     The study aims to assess and analyze some selected antioxidants and laboratory parameters~     during hospitalization of the patients with acute pancreatitis. It will allow to better~     understanding of the mechanisms of disease and the development of better diagnostic,~     treatment and monitoring.~      It is an observational diagnostic study and does not involve any additional administration~     of medicinal substances, modification of treatment or dropping the use of routine methods of~     treatment of a disease. The study procedure includes detailed personal medical history as~     separate document like as a routine medical interview, and three times taking a small amount~     of venous blood (together about 15 ml), in the first, third, and seventh day of~     hospitalization (in the case of longer hospital treatment).~   "
2219|NCT03028168|"~     Current therapies for heart failure (HF) bring together strategies to improve quality of~     life and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients~     present changes in the musculoskeletal system and inspiratory muscle weakness, which may be~     restored by inspiratory muscle training, thus increasing respiratory muscle strength and~     endurance, maximum oxygen consumption (VO2), functional capacity, respiratory responses to~     exercise, and quality of life. Yoga therapies have been shown to improve quality of life,~     inflammatory markers, and VO2 peak in HF patients, mostly with reduced ejection fraction~     (HFrEF). However, the effect of different yoga breathing techniques in patients with HF with~     preserved ejection fraction (HFpEF) has yet to be assessed.~   "
2220|NCT03028155|"~     Colorectal Cancer (CRC) is the third most common cancer and the fourth most common cause of~     cancer-related death worldwide. CRC frequently gives rise to transcoelomic spread of tumor~     cells in the peritoneal cavity, which ultimately leads to Peritoneal Carcinomatosis (PC). A~     new loco-regional treatment modality combines Cytoreductive Surgery (CRS) and Hyperthermic~     Intraperitoneal Peroperative Chemotherapy (HIPEC). The current HIPEC dosing regimens for the~     treatment of colorectal PC can be divided into body surface area (BSA)-based protocols and~     concentration-based protocols. Most groups currently use a drug dose based on calculated BSA~     (mg/m2) in analogy to systemic chemotherapy regimens. These regimens take BSA as a measure~     for the effective contact area, represented as the peritoneal surface in the formula for~     dose intensification. However, an imperfect correlation exists between actual peritoneal~     surface area and calculated BSA. Sex differences, but also altered pathophysiological~     characteristics or frequent complications in patients (ascites) are responsible for~     differences in peritoneal surface areas, which in turn affect absorption characteristics.~     This takes us away from the initial homogenous drug concentration desired, increasing the~     variability in the systemic and tumor exposure to the drug. Pharmacokinetic changes induced~     by the volume of chemotherapy solution with constant drug dose, administered~     intraperitoneally, have already been reported. This resulted in less precise predictions of~     the toxicity associated with the treatment. By contrast, some groups use a totally different~     dosimetry regimen based on concentration. From a pharmacologic point of view, the big~     advantage of a concentration-based system is that the residual tumor nodules after CRS are~     exposed to a constant diffusional force and, thus, cytotoxicity. Unfortunately the prize to~     be paid for a better prediction of the efficacy of the IP chemotherapy is a high~     unpredictability of the levels of plasmatic cancer chemotherapy and, thus, toxicity. This~     randomised non-blinded phase III clinical trial will be the first trial to pharmacologically~     evaluate the two dosing regimens, BSA-based and concentration-based, both applied as~     standard of care in current practice.~   "
2221|NCT03028142|"~     This is a phase II, randomised, double blind, placebo controlled, complete block, three way~     crossover study to investigate treatment with nebulised RPL554 and tiotropium together in~     patients with moderate to severe chronic obstructive pulmonary disease (COPD). The purpose~     of this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when~     used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium)~     whilst dosing the RPL554 to steady state blood levels. It is planned to randomise up to 30~     patients to have 24 evaluable patients at one study centre. In each treatment period,~     patients will receive an open label dose of tiotropium from a dry power inhaler (DPI)~     followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo~     (depending on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3.~     The dose of RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will~     not be an evening dose on Day 3.~   "
2222|NCT03028129|"~     The purpose of this study is to determine if the combination rifapentine + isoniazid is~     effective in the prevention of tuberculosis in a prison population, exposed to the high~     endemicity of the disease.~   "
2225|NCT03028090|"~     This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip~     Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central~     catheter (PICC) tip confirmation technology. The study was to promote the development of a~     software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform.~     All study participants received PICCs as their standard of care.~   "
2226|NCT03028077|"~     This study was conducted to investigate the effects of daily supplementation of GS-3K8 or~     GINst15 on acute respiratory illness (ARI) in healthy subjects.~   "
2227|NCT03028064|"~     Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing~     population, antiplatelet drugs are increasingly being prescribed for treatment and~     prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet~     dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the~     management of patients on antiplatelet drugs or anticoagulants is a challenge. One has to~     carefully balance the bleeding against thrombo-embolic risks. Therefore measuring platelet~     function should be integral in the management plan. A quantitative measurement allows~     titration of platelet function in accordance with bleeding or thromboembolic risk. Platelet~     function has not been studied in a large cohort of patients with acute upper~     gastrointestinal bleeding. As a first step, the study will determine if platelet dysfunction~     is associated with clinical outcome. In this prospective, observational single centre cohort~     study of consecutive patients with overt signs of acute upper gastrointestinal bleeding,~     their platelet function by point of care tests (light transmittance aggregometry, verify now~     p2y12,the platelet function analysis system (PFA-100) upon their admissions. Patients will~     be followed up for 30 days after trial enrollment. The primary endpoint is defined as~     significant bleeding that requires interventions (endoscopic, radiologic or surgery).~     Secondary end points include cardio- and cerebrovascular thrombo-embolic events and all~     cause deaths. A receiver operating characteristic (ROC) curve analysis is calculated for~     each point-of-care test to evaluate if individual test can distinguish between patients with~     and without primary end point. This study aims to evaluate the capability of platelet~     function tests to predict clinical outcome in patients with AUGIB. Logistic regression~     models will then be built in search for independent correlates to the primary and secondary~     endpoints and to adjust for confounding variables.~   "
2228|NCT03028051|"~     Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that~     aims to analyze life style factors, socioeconomic and psychometric properties, metabolic~     problems, drug use, quality of life and biochemical variables in chronic non-cancer pain~     patients. The life style factors will be compared to those of normal population. At~     baseline, the study patients fill in questionnaires (A-E), the patients´ weight, length,~     waist and blood pressure are measured, pain-related factors are recorded and blood samples~     taken. Changes in the quality of life of the study patients will be evaluated by~     questionnaires during follow-up at 2 years and 5 years.~   "
2229|NCT03028038|"~     The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is~     effective in reducing alveolar bone loss that happens after each rapid maxillary expansion~     (RME) on the buccal aspect of the posterior teeth.~      16 patients with a skeletal maxillary constriction aged between 10-16 years old will get~     into orthodontic treatment to widen the maxilla using Hyrax appliance.~      An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will~     be injected in one half of each patient mouth in a split-mouth design, beneath the buccal~     periosteal of the first molars and first premolars, the halves will be chosen randomly.~      High resolution CBCT images will be taken before and after orthodontic treatment to analyze~     buccal bone thickness and height changes.~   "
2230|NCT03028025|"~     The primary objectives of this study are to evaluate the performance of StatSeal Advanced~     used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB)~     relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or~     24 hours, whichever occurs first, and the Time to Hemostasis (TTH).~   "
2231|NCT03028012|"~     Hypothesis~      The main hypothesis of this study is that anti-inflammatory medications (ketorolac or~     dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in~     trigger point injections where a local twitch response is evoked at the time of the~     injection.~      Purpose/Specific Aims~      The primary objective of this study is to compare the efficacy of three substances used in~     TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID~     (ketorolac), or only a local anesthetic (lidocaine).~   "
2232|NCT03027999|"~     Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium~     joints and, in the absence of appropriate background therapy, leads to progressive joint~     destruction, functional, psychological, social and occupational repercussions.~      Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to~     evaluate the therapeutic response to RTX and re-administer it from the 24th week when the~     goal of remission has not been achieved. However, the optimal modality for reprocessing~     remains to be determined.~      To this end, different approaches have been explored, such as lymphocyte typing or~     ultrasound monitoring. The pace of these examinations, however, remains wide and their cost~     is not negligible. This is why we propose here to explore the track of a tight follow-up~     nurse DAS28.~      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier~     than the current medical follow-up.~      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier~     than the current medical follow-up~   "
2233|NCT03027986|"~     Urinary incontinence (UI) is defined by the International Continence Society as any~     involuntary loss of urine complained by the patient. The anatomical and histological~     specificities of the pelvic floor muscles (PFM) give them a key role in the control of~     urination but also in the control of postural stability. These activities are involuntary~     automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence~     are not only due to the loss of voluntary contraction of the pelvic floor muscles. The~     mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep~     muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is~     recommended in the treatment of urinary incontinence after prostatectomy (Grade A), but~     there is a lack of evidence to define the best treatment regimen for PFM rehabilitation.~      Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.~        -  The first one is made in individual box, in supine position. By analytic contractions~          of the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback.~          This method used voluntary contractions of MPP.~        -  The second is realized in various positions following a gravity progression, in~          individual and /or common room. This technique aims to restore a stabilization of the~          entire lumbo-pelvic region by postural recruitment involving synergistic contractions~          of the PFM.~      These trials propose to compare these two rehabilitation programs on populations with~     postoperative follow-up of more than 12 months.~      We chose to objectify the urine leaks with the pad test (weighing of the protections urinary~     over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad~     of 3 times in 24 hours has been used by numerous studies and its reproducibility and~     reliability are established.~      Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental~     health and decreased of physical fitness. We therefore wish to observe these parameters for~     each of our two randomized groups~   "
2234|NCT03027973|"~     This study compares two treatments for the management of heavy menstrual bleeding,~     ulipristal acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half~     of the participants will receive UPA and a placebo, and the other half will receive TEA and~     a placebo.~   "
2235|NCT03027960|"~     The investigators propose a small pilot proof of concept study to not only prove the~     existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin~     in patients with heart failure. The investigators propose a 50 patient randomized,~     double-blind, placebo-controlled crossover study with patients with stable HF, type II~     diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.~   "
2236|NCT03027947|"~     The goals of this study are to provide sensory information to amputees and reduce phantom~     limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal~     nerves convey sensory information from peripheral nerves to higher order centers in the~     brain. These structures still remain intact after amputation and electrical stimulation of~     the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated~     to generate paresthetic sensory percepts referred to portions of the distal limb. Further,~     there is recent evidence that careful modulation of stimulation parameters can convert~     paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in~     amputees. However, it is currently unclear whether it is possible to achieve this same~     conversion when stimulating the spinal nerves, and if those naturalistic sensations can have~     positive effects on phantom limb pain. As a first step towards those goals, in this study,~     the investigators will quantify the sensations generated by electrical stimulation of the~     spinal nerves, study the relationship between stimulation parameters and the quality of~     those sensations, measure changes in control of a prosthesis with sensory stimulation, and~     quantify the effects of that stimulation on the perception of the phantom limb and any~     associated pain.~   "
2237|NCT03027934|"~     The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples~     obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in~     a cross-over design.~   "
2238|NCT03027921|"~     The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic~     liver diseases. The early detection of fibrosis is important for determining disease~     progression and postponing the evolution of chronic hepatitis into cirrhosis via the~     implementation of prompt and specific treatment. However, as chronic liver disease can~     remain asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly,~     when life-threatening complications start appearing.~      Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade.~     In this setting, blood fibrosis tests and transient elastography have been shown to be~     accurate, and are now commonly used as first-intention tests for liver fibrosis diagnosis in~     chronic liver diseases. However, these tests are usually performed by a hepatologist to whom~     the patient has been referred following the appearance of symptoms suggestive of chronic~     liver disease. Thus the number of patient diagnosed early by these new tools, that is in the~     period before symptoms start appearing and during which preventative measures may be~     particularly beneficial, remains quite low in relation to the prevalence of the disease.~     This prevalence has been estimated to 0.5 to 2.8 % in general population.~      Many studies have identified the value of hemodynamic and morphological ultrasound parameter~     in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely~     used for various symptoms, and thus could be an excellent way to detect patients with signs~     evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for~     confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be~     feasible during a nonspecific US examination, and by any radiologist, these signs should be~     easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase~     the screening interest of ultrasound examination.~      The main aim of the present study was thus to validate 3 simple US signs in patients~     referred for ultrasound abdominal examination for reasons other than suspicion of liver~     disease.~   "
2239|NCT03027908|"~     This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240~     healthy female and male participants aged over 18 years will participate. The participants~     will be randomised into two groups. Participants will be randomly assigned to the test~     groups according the allocation table prepared by the Statistician.~      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.~     After enrollment participants will have their teeth cleaned using a professional prophylaxis~     polish by the study hygienist. The participants will then be provided with a standard~     cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to~     four weeks. After this time, they will return to the test site and have the baseline dental~     assessments. Participants will then be randomly allocated to one of the two test products~     which they will use at home, twice a day for the duration of the study. Dental assessments~     will be conducted after 13 and 26 weeks of product use at the study site.~   "
2240|NCT03027895|"~     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and~     tubular metal stent on the drainage of pancreatic pseudocyst, mainly to observe the~     complication rate after treatment.~   "
2241|NCT03027882|"~     The purpose of this study is to examine the inter/intra rater reliability as well as the~     validity of the Swing Test in asymptomatic adults . In addition, this study will examine if~     there are musculoskeletal predictors to the movement quality of the swing test.~      The Swing Test is a movement test used by physical therapists to identify movement problems~     during a simulated running stride~   "
2242|NCT03027869|"~     Healthy volunteers will be recruited. All subjects will be tested a battery of~     neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET)~     and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with~     transcranial direct current stimulation (tDCS) for 15 minutes. Half of subjects will receive~     real tDCS and the other half will receive sham tDCS.~   "
2243|NCT03027856|"~     The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS~     for treatment of coronary bifurcation lesions.~   "
2256|NCT03027687|"~     Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over~     the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time~     till smoking the first cigarette after the intervention. More interesting however, is to~     study whether actual cigarette consumption decreases after repetitive tDCS. The current~     study will explore this by means of EMA in a large sample of 60 smokers. Participants will~     receive twice daily sessions of real tDCS or sham for three days in one week. Furthermore,~     electrophysiological responses (ERPs) will be measured at baseline, one day after the last~     tDCS session and at three months follow up to study the working mechanism behind the effects~     of tDCS.~   "
2257|NCT03027674|"~     Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in~     patients with secondary Raynaud's phenomenon (RP).~      Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10~     patients with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the~     other hand were applied. The thumbs didn't receive any cream and served as a control group.~     The primary outcome was the improvement of blood flow and vessel diameter of the digital~     arteries measured by high frequency color Doppler ultrasound before and 1 hour after~     treatment.~   "
2244|NCT03027843|"~     Assisted reproduction treatment in patients with low ovarian reserve is a big difficult~     clinical problem. Growth hormone (GH) is crucial in the development of follicles since~     preantral follicle to ovulation and can promote steroid hormones and gamete formation,~     increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research~     shows that GH can improve egg quality through regulating mitochondrial function of the~     oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion~     of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of~     assisted reproduction 30 years experience of applicable people, but drug dosage, drug~     intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation~     medicine expert consensus recommend joint GH for poor ovarian response, repeated~     implantation failure patients and older patients assisted fertility treatment, but not on~     the specific use time limit, the daily dose of drugs and curative effect. How to maximize~     growth hormone potential advantage in improving the egg quality bothers the clinical~     doctors. We had a self-controlled retrospective analyses in growth hormone application and~     found that the average daily injections of GH dose 2 iu for 45 days can significantly~     improve the embryo quality in patients with low ovarian reaction. And now long-acting~     recombinant human growth hormone is available, which make it convenient for patients. A~     forward-looking experimental is expected to answer clinical practical problems and provide~     proper GH regimen for low ovarian responder.~   "
2245|NCT03027830|"~     Even in the era of drug-eluting stents, bifurcation lesions remain one of the most~     challenging lesion subsets in coronary intervention practice. This study was performed to~     evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch~     intervention strategy.~   "
2246|NCT03027817|"~     Positioning a patient in prone position under anaesthesia significantly alters~     cardiovascular physiology. Cervical myelopathy patients are known to have autonomic~     dysfunction. Such patients when positioned in prone position under anaesthesia carry a~     higher risk of developing hemodynamic changes and this can compromise spinal cord perfusion.~      This prospective observational study was conducted on 30 patients with cervical myelopathy~     who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive~     cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic~     parameters. The hemodynamic parameters were recorded at baseline, post induction, post~     intubation, prior to prone position, post prone position, and every five minutes thereafter~     upto 20mins.~      The hemodynamic parameters that were recorded using the NICOM monitor:~        -  HR - Heart rate (beats /min)~        -  NIBP - non invasive blood pressure (mmHg)~        -  MAP - mean arterial pressure(mmHg)~        -  CO - cardiac output (l/min)~        -  CI - cardiac index (l/min/m2)~        -  SV - Stroke volume (ml/beat)~        -  SVV -stroke volume variability (%)~        -  TPR - total peripheral resistance (dynes. sec/cm5)~   "
2247|NCT03027804|"~     A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure~     phenomenon and feed more complex biomechanical models to be integrated with clinical imaging~     with the final aim to predict Ross operation's outcomes and define strategies to ameliorate~     its results.~   "
2248|NCT03027791|"~     Subjects will participate in a 12-week church-based intervention with five separate~     components: 1) participation in weekly group sessions; 2) daily use of Fitbit activity~     tracker; 3) daily, twice a day blood pressure monitoring; 4) daily online food tracking; and~     5) daily use of VR at home (starting at week 6). Participants will also receive phone~     contacts from nurse coaches (twice a week during the first 4 weeks, then once a week for the~     remaining 8 weeks), who will answer questions and provide support.~   "
2249|NCT03027778|"~     The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling~     exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and~     2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic~     parameters 4 months after finishing the exercise intervention (8 months after study~     initiation).~      The investigators also aim to examine the impact of intradialytic pedaling exercise on~     general health, anthropometric measures, physical function, and routine laboratory blood~     markers as secondary outcome measures, as well as to assess feasibility, safety and adverse~     events associated with the intradialytic pedalling exercise.~      Qualitative assessments will be conducted among participants to evaluate the acceptability,~     feasibility and sustainability of intradialytic pedalling exercise.~      Recruitment of more participants in the future will be considered if warranted.~   "
2250|NCT03027765|"~     The purpose of the study is~        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and~          Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.~        -  To assess the knowledge, attitude and awareness of constructed space maintainers for~          pediatric patients' guardians at Pediatric Dentistry and Dental Public Health~          Department, Faculty of Oral and Dental Medicine, Cairo University.~      and~      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space~     maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty~     of Oral and Dental Medicine, Cairo University.~   "
2251|NCT03027752|"~     Comparison of two methods for revascularization of the bifurcation of common carotid artery:~     carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty~     compared with new technique of carotid endarterectomy with autoarterial remodeling of~     bifurcation of the common carotid artery~   "
2252|NCT03027739|"~     CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses~     in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the~     safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of~     relapse as defined by MRD+ status.~   "
2253|NCT03027726|"~     Background: The global pandemic obesity has led to increased risk for prediabetes and type 2~     diabetes (T2D).~      Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program~     including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To~     identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear~     cells in pre-adolescents with high risk to develop T2D and its response to a~     multidisciplinary intervention program including exercise.~   "
2254|NCT03027713|"~     The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in~     healthy lung patients due to obtain a reference to guide the weaning in those patients~   "
2258|NCT03027661|"~     This is a prospective randomized controlled trial in which patients that are scheduled to~     undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical~     block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using~     block randomization. The intervention would be performed after the patient is under general~     anesthesia, prior to starting the surgery. Patients would be consented in the office or~     preoperative area (before receiving sedatives). As far as the intervention itself, it would~     consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,~     which is standard technique for para-cervical block. The remainder of the procedure will~     then continue in a regular fashion. Alternatively, patients in the control group will be~     injected with 5 mL of normal saline. The surgeon would be blinded as to patient allocation.~     Research staff will have previously prepared the formulations (saline or bupivacaine) and~     have sent them to the operating room prior to beginning the procedure depending on assigned~     group. At the end of the case, pain will be assessed using a visual analogue scale with a~     range from 0 to 10 by one of the researches who will also be blinded to the group. This will~     be done at 30 and 60 minutes after surgical stop time. Additional pain control in the~     postanesthesia care unit (PACU) will be standardized to all patients.~      Hypothesis:~      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy~     significantly reduces pain after the procedure~   "
2259|NCT03027648|"~     Objective: To investigate the effects of levonorgestrel-releasing intrauterine system~     (LNG-IUS) for symptomatic adenomyosis.~      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis~     diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or~     inpatient clinics of Peking Union Medical College Hospital were given the treatment of~     LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the~     parameters were recorded prospectively, including carrying status of IUS, symptoms and~     scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters,~     menstruation patterns and adverse effects.~      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea~      Second outcome measures: carrying status of IUS~   "
2260|NCT03027635|"~     Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small~     volume fluid drainage at home. The treatment may improve the management of ascites and have~     a beneficial effect on the quality of life.~      This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter~     (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic~     resistant ascites.~      The trial is an investigator initiated, randomised, single blind, parallel arm, controlled~     trial.~      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will~     receive ciprofloxacin to prevent spontaneous bacterial peritonitis.~      We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total~     duration of follow up is six months. The primary outcome is paracentesis free survival.~   "
2261|NCT03027622|"~     The complications that could occur during or after the extraction of the mandibular third~     molar teeth with pericoronitis affect patient's life quality considerably. Various scales~     are used to reveal how much the life quality of patients is affected this treatment. The aim~     of this study is to identify the long term life quality of patients through the OHIP-14 TR~     scale without removing the mandibular third molar teeth with mild pericoronitis.~   "
2262|NCT03027609|"~     Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic~     of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia~     caused by P. aeruginosa.~   "
2263|NCT03027596|"~     Burned skin areas, which were initially vital, can be irreversibly damaged by wound~     progression. The aim of the present study is to evaluate the feasibility of ischemic~     conditioning to reduce secondary wound progression.~   "
2264|NCT03027583|"~     This trial is a single-site, randomised, double blind, placebo-controlled, two-armed~     parallel-group trial in healthy adult volunteers. The trial will investigate the effect of~     oral supplementation of the probiotic strain Bif195 on the ability to attenuate~     exercise-induced deterioration of intestinal barrier function and gastrointestinal symptoms.~   "
2265|NCT03027570|"~     80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of~     overweight children.The intervention group will use the app Just Dance Now and The control~     group will be exposed to the usual program without the app. Measurements will be performed~     at the beginning of the program, the end and 3 months after completion of the intervention.~   "
2266|NCT03027557|"~     The only known cure for primary hyperparathyroidism is surgical removal of one or more~     parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not~     want to undergo a procedure due to fear of the associated risks. Therefore a medical~     alternative is warranted.~      This study aims to evaluate the effects of Denosumab alone, and in combination with~     Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism,~     with mild osteoporosis. To the best of our knowledge no previously reported randomized~     controlled trial has investigated the use of denosumab in primary hyperparathyroidism.~      60 patients will be enrolled in three different treatment-groups: 20 receiving both~     Denosumab and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients~     included do not meet the criteria for, or have no wish for a surgical procedure.~      By combining the two drugs, this study could possibly contribute to the discovery of a~     realistic medical alternative to surgery. It is expected that the therapy will be able to~     both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance~     bone-structure. The therapy thus has the potential of preventing fractures and possibly~     other long-term effects of primary hyperparathyroidism such as formation of kidney stones,~     and coronary calcification. Another objective of this project is to investigate whether the~     combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby~     de facto cure the disease.~   "
2267|NCT03027544|"~     This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy~     for refractory brain metastases.~   "
2268|NCT03027531|"~     This study is a randomized controlled trial to test acceptability, feasibility and~     preliminary efficacy of an interactive computer-based intervention with individualized~     feedback to promote sexual health in adolescents and young adults with assessment of~     behavioral and biomarker outcomes.~   "
2269|NCT03027518|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College~     students. This program is called WILD 5 Wellness: A 30-Day Intervention. Results for this~     study will be quantified through the use of standardized self-report questionnaires~     administered prior to and after students complete the WILD 5 program (Group 1) or 30 days of~     inactive participation (Group 2), and again approximately 30 days later when the initially~     inactive group (Group 2) will have just completed their active participation in the WILD 5~     program and the first WILD 5 group (Group 1) will be approximately 30 days out from~     completion of their WILD 5 active portion. Data will be collected to evaluate participants'~     adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention.~     It is expected that this 30-day integrated, prescriptive, and trackable program will be~     found to be an efficacious wellness intervention for Beloit College students as compared to~     the control (inactive) group of students not participating in the Active program.~   "
2270|NCT03027505|"~     MUAC only is a non-inferiority trial with external control carried out between January 2017~     and December 2017 in the Yako district (northern region), Burkina Faso.~      The objective of this study is to evaluate an integrated protocol for acute malnourished~     children without medical complication. The hypotheses of the integrated protocol include :~        1. A global treatment of acute malnutrition (moderate and severe) with a single treatment~          (RUTF) would improve the functioning of the program through early identification of~          acutely malnourished children, while achieving a better coverage and using a single~          supply chain.~        2. A gradual reduction of RUTF dosage according to a child's MUAC status could~          significantly increase the number of children on treatment without increasing overall~          RUTF quantity while maintaining similar recovery rates.~   "
2271|NCT03027492|"~     In the last few years, a new clinical entity has emerged which includes patients who~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have celiac disease (CD) or wheat allergy. This clinical condition~     has been named non-celiac gluten sensitivity (NCGS), although in a recent article, the~     investigators suggested the term non-celiac wheat sensitivity (NCWS), because it is not~     known to date what component of wheat actually causes the symptoms. The clinical picture of~     NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea~     and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis)~     and very different extra-intestinal and systemic manifestations (headache, depression,~     anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle~     pain, leg or arm numbness, and anemia). Nowadays, there no data about a possible~     relationship between gynaecological disorders and food ingestion and food~     allergy/intolerance. Therefore, the aims of the present study are to investigate 1) the~     prevalence and characteristics of gynaecological disorders in NCWS patients compared to CD~     and irritable bowel syndrome (IBS) controls, and 2) the modification of such disorders in~     NCWS patients after a gluten (wheat)-free diet.~   "
2272|NCT03027479|"~     the aim is to study skeletal muscle metabolism alterations métaboliques associated with~     weight loss in women with ovarian and/or endometrial cancer according to BMI.~   "
2273|NCT03027466|"~     Background:~      Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as~     a threat if they think it suggests that they are unable to meet the challenges of stopping.~     When people feel such a threat to their sense of self-identity, they may get defensive. They~     may want to downplay the importance of quitting. This could make them try to quit less.~     Self-affirmation is a process of focusing on strengths and values. This can offset threats~     to the self and promote healthier behavior.~      Objective:~      To explore people s values, smoking attitudes, and smoking behavior.~      Eligibility:~      People ages 18 and older who smoke~      Design:~      The study takes place entirely on a mobile device.~      Participants will give their age, gender, data about their smoking habits, and desired quit~     date.~      Then they will get different texts about quitting.~      Participants will answer follow-up surveys 1 and 3 months later.~   "
2274|NCT03027453|"~     The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific~     Treatments such as endovascular treatment. It will also enable the participating hospitals~     to compare the quality of care of their facility. At the same time, B-SPATIAL will provide~     an opportunity of scientific evaluation of new therapeutic procedures or specific treatments~     in stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous~     thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will~     allow for an identification of key quality indicators that assure valid quality assessment~     aiming at a reduced documentation load for future quality management.~   "
2275|NCT03027440|"~     Background:~      Suicide rates are rising. In 2013, it was the third leading cause of death in children ages~     10 14. It was the second leading cause of death for ages 15 24. Many risk factors for~     suicide have been found. But it is hard to predict. Evidence is growing that some factors~     that may make people vulnerable to suicide can be identified before birth or in early~     childhood. Researchers want to study vulnerability to suicide. They want to look at~     different kinds of development. These include prenatal, social, behavioral, cognitive, and~     neurologic. They will do this by linking data from the United States Collaborate Perinatal~     Project (CPP) to the National Death Index (NDI). The CPP data are from about 50,000 children~     born to mothers who enrolled in the 1960s. The CPP observed and examined about 60,000~     pregnancies. Then it followed the babies from when they were born through age 7. The CPP~     collected data on things like family and medical history, economic status, and behavior. The~     NDI has data on the date and cause of death.~      Objective:~      To link data from the CPP to the NDI in order to study certain precursors to suicide.~      Eligibility:~      Children born to women who enrolled in the CPP in 1959 1966 and known to be alive at age 7~      Design:~      Data on children from the CPP will be submitted electronically to the NDI. It will be~     encrypted and data from the NDI will be deidentified to protect confidentiality. It will~     then be merged with existing CPP data. Researchers will analyze the data.~   "
2297|NCT03027128|"~     The purpose of this study is to determine whether haNK™ for Infusion is safe and effective~     in the treatment of metastatic or locally advanced solid tumors.~   "
14398|NCT02868801|"~     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained~     release tablet versus placebo for postherpetic neuralgia.~   "
2276|NCT03027427|"~     Background:~      Certain stomach cancers are rare, but they have high mortality rates. Researchers want to~     learn more about gastric (stomach) tumors. In this study, they want to collect data from~     people who have stomach cancer or are at risk to get it. This data will be used to see if~     the people can be in other studies.~      Objective:~      To study tissue from stomach tumors and find people eligible for more studies on gastric~     cancer.~      Eligibility:~      Adults at least 18 years old who have or may have stomach cancer, lesions that may be~     related to stomach cancer, or an inherited disorder that leads to stomach cancer.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Heart tests~      Scans or ultrasound.~      For the scans, participants lie in a machine that takes pictures. For some scans, they will~     swallow or be injected with a small amount of radioactive material. Special cameras will~     show the material in the body.~      Tumor sample taken with a needle or surgery~      Some participants will have an endoscopy. A long, flexible tube with a camera will be~     inserted through the mouth into the stomach. The tube will collect tissue from the stomach.~      Some participants may have follow-up visits. Some may be invited to join other studies.~     Others will be contacted by phone to see how they are doing.~   "
2277|NCT03027414|"~     Background:~      Researchers want to better understand brain processes related to fear and anxiety. They want~     to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can~     reduce anxiety.~      Objective:~      To see how TMS affects fear and anxiety through memory and attention tasks.~      Eligibility:~      Healthy people ages 18 50 who are right-handed~      Design:~      Participants will be screened through another protocol.~      Participants in the pilot study will have 1 visit. This includes:~      Urine tests~      Questionnaires about mood and thinking~      Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will~     be shocked to find out what level of shock is uncomfortable but tolerable. They will hear~     loud, sudden noises through headphones.~      TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they~     might receive fake TMS. This feels the same as real TMS. They will perform simple tasks.~     Participants in the main study will have 2 visits within 2 weeks.~      The first visit includes:~      Urine tests~      Questionnaires about mood and thinking~      MRI: Participants lie on a table that slides into a scanner. They will be in the scanner~     about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.~      The second visit includes:~      Shock and startle workup~      TMS~   "
2278|NCT03027401|"~     Background:~      Saliva, blood, tissue, and cancer contain DNA. DNA makes the instruction book for the~     cells in the body. Cancer is caused by changes in DNA that affect cell function. Researchers~     want to test DNA of people with tumors. They want to look for genetic changes in tumors that~     could be targets for treatment. Because DNA can change as cancer changes, more testing may~     be done at different times.~      Objectives:~      To find the DNA changes in cancer that may help guide treatment. To collect samples and data~     to be used in future studies.~      Eligibility:~      People any age with cancer or a pre-cancerous tumor~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          Participants will give a sample of their tumor. This is usually from a previous~          procedure. Participants will give a saliva or blood sample. They cannot eat, drink,~          smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon~          of saliva into a tube.~        -  Some participants may have a punch biopsy instead. A small instrument will take a small~          piece of skin.~        -  Researchers will collect data from participants medical records.~        -  Participants will answer questions about their family health history. They will also~          answer questions about their views on the study, including possible unexpected results.~        -  Extra blood or tissue samples may be taken at other times during the participants~          treatment. All samples will be saved in secure ClinOmics freezers to be used in future~          studies.~        -  Participants will be told by their doctors if any test results affect their health or~          their cancer treatment.~   "
2279|NCT03027388|"~     Background:~      The brain is separated from the rest of the blood stream by the blood-brain barrier. This is~     like a filter that protects the brain. But is also a challenge when medicines need to get~     into the brain. Researchers want to give the new drug LB100 to people before brain tumor~     surgery. They will measure how much LB100 is in the blood and how much gets into the brain.~     This may help with the use of LB100 to treat brain tumors in the future.~      Objective:~      To see if LB100 can pass into the brain.~      Eligibility:~      People at least 18 years old with a brain tumor that requires surgery~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Neurosurgery evaluation~      Scans~      Heart tests~      Tumor sample. This can be from a previous procedure.~      Participants will have their brain surgery at the Clinical Center.~      Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours~     during surgery.~      Participants will have blood taken 7 times in the 8 hours after getting the study drug.~      Tumor samples will be taken during surgery.~      Participants will have a heart test after getting the study drug. Sticky pads on the skin~     will measure electrical activity of the heart.~      Two weeks after leaving the hospital, participants will have a follow-up visit. They will~     have a physical exam and blood tests.~      One month after surgery, they will be contacted in person or by phone to see how they are~     doing.~   "
2280|NCT03027375|"~     This trial will assess the efficacy and safety of QSG in CHF.~   "
2281|NCT03027362|"~     The goals of this study are: 1) to investigate the efficacy of combining ketamine with~     intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of~     ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to~     explore the relationship between any ketamine-induced changes in learning and memory and~     duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a~     diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen~     to pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the~     study.~   "
2298|NCT03027115|"~     Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor~     antagonist affects the likelihood of male patients developing post-operative urinary~     retention following hernia repair.~   "
2637|NCT03022695|"~     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate~     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.~   "
2282|NCT03027349|"~     Background:~      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the~     diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.~      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be~     considered a good candidate tool in the diagnosis of PHPT.~      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the~     diagnosis of PHPT.~      Study design: Retrospective, observational, cross-sectional, case-control clinical trial~     will be carried out.~      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.~   "
2283|NCT03027336|"~     The overall objective of the study is to assess the efficacy of Coleosoma formulation~     (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic~     patients.~   "
2284|NCT03027323|"~     Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops~     to critical levels due to several possible reasons. The medical staff treating the patient~     will need to find out the reason for your drop in blood pressure as soon as possible. When~     treating low blood pressure, the medical staff typically performs a procedure called central~     venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under~     the collarbone) by inserting a needle into the vein. By doing this, the medical staff can~     measure the pressures in the patient's veins or give medicine to the patient while they are~     in the hospital.~      The purpose of this study is to compare the time needed to complete CVC using the AxoTrack~     device to CVC guided by landmarks on a patient's body. The investigators expect that there~     will be a maximum of 30 patients enrolled in this study.~   "
2285|NCT03027310|"~     Objectives:~      The purpose of this protocol is to study the phenotypic spectrum and the pathophysiology of~     tremor syndromes by performing small behavioral, electrophysiological and neuroimaging~     sub-studies. The protocol includes techniques with minimal risk (standard clinical~     evaluation, MRI, EEG, peripheral nerve stimulation, single and paired pulse TMS) and certain~     sub-studies may involve healthy volunteers. This protocol aims to study neurophysiological~     and behavioral outcomes in defined groups of patients with action tremor syndromes, to~     inform future hypothesis-driven and confirmatory studies, which will be developed and~     submitted as separate protocols. For this purpose, we aim to conduct 1) pilot sub-studies,~     2) individual patient investigations, 3) training studies for investigators, as well as 4)~     technical development studies.~      Study population:~      We intend to up to 300 patients with essential tremor and other isolated action tremor~     syndromes, as well as 150 healthy volunteers.~      Design:~      This is a non-hypothesis driven study involving standardized phenotyping as well as thematic~     sub-studies. After patients and healthy volunteers complete a screening visit, patients will~     undergo a standardized phenotyping visit including clinical rating scales as well as~     electrophysiological tremor-workup. Patient and healthy controls may then be enrolled in~     sub-studies, which are pertinent to the theme of this protocol. If a sub-study leads to~     results of interest, a separate protocol will be submitted with a priori hypotheses,~     specific study design and power analysis adapted from the pilot or exploratory sub-studies~     performed in the present protocol. At any given time, no more than 5 sub-studies can be~     actively accruing subjects concurrently.~      Outcome measures:~      Outcome measures applied in this protocol involve methods for tremor phenotyping such as~     clinical rating scales and questionnaires, electrophysiological tremor studies, videotaped~     exam, as well as digitizing based tasks. During the thematic studies focused on the~     neurophysiological characterization of tremor syndromes, the following outcome measures will~     be applied: EMG: we will analyze tremor signals using spectral analyses, coherence analyses,~     and in combination with accelerometry, EEG, MEG, and TMS to explore tremor-networks. MRI: we~     will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between~     seed and target regions of interest (using DTI); morphometry of brain regions (using VBM);~     and different neurotransmitter levels in brain regions of interest (using MRS). EEG and MEG:~     we will quantify measures such as corticomuscular coherence, event- or task-related~     potentials, synchronization/desynchronization, and coherence between sensors or sources~     located close to the brain areas of interest. TMS: we will analyze measures such as MEP~     amplitude and central conduction time, as well as measures of cortical excitability and~     inhibition paradigms. Behavioral measures: we will quantify measures of voluntary movement~     involving tremor, reaction times to initiate movements, EMG patterns, movement kinematics~     (position, velocity, acceleration, curvature), eye movement. Actigraphy: We will quantify~     continuous recordings of motion sensors involving multiaxial accelerometers and gyroscopes.~     Furthermore, we may measure autonomic data during the course of experiments (such as blood~     pressure, skin conductance, and respiratory rate) which would correlate to the outcome~     measures.~   "
2286|NCT03027284|"~     The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in~     combination with other anti-cancer agents in Japanese participants with advanced and/or~     metastatic cancer.~   "
2287|NCT03027258|"~     The investigators propose to adopt sustainable community networks (in this case churches) to~     implement an integrated community-based screening that incorporates mobile health technology~     (mHealth) to make prenatal results available at the point-of-delivery and a simplified~     medical decision algorithm to guide medical management.~   "
2288|NCT03027245|"~     Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective,~     multicenter cohort study conducted to characterize and determine the incidence of~     eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of~     eribulin-induced PN in participants treated with eribulin in a real-life setting for locally~     advanced or metastatic breast cancer following one or two prior chemotherapeutic regimens~     for advanced disease.~   "
2289|NCT03027232|"~     The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The~     aims of these in vitro studies are to determine the cellular and intracellular mechanisms by~     which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.~   "
2290|NCT03027219|"~     Objective: flow change of arterial anastomosis site during free flap surgery in diabetic~     patients Background: No research was published about flow change of arterial anastomosis~     site of free flap during surgery Plan: Using Duplex sonography, various parameters related~     flap perfusion will be evaluated before and after the administration of alprostadil~   "
2291|NCT03027206|"~     Objective to evaluate the effects of vibration techniques and acceleration of expiratory~     flow on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the~     Intensive Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and~     interventional study, in which 28 PTNB were randomly divided into two groups: Group 1~     submitted to the vibration technique and Group 2 - to the acceleration of the expiratory~     flow, both techniques were applied in an interval of up to ten minutes, for Three~     consecutive days. The pain indicators were evaluated according to the PIPP scale in three~     moments. For statistical analysis, the Friedman tests and Variance Analysis were applied,~     the level of significance adopted was 5%.~   "
2292|NCT03027193|"~     A phase I dose escalation study to assess the safety and immunogenicity of the candidate~     vaccine ChAdOx2 HAV in healthy volunteers.~      Volunteers will be recruited and vaccinated in Oxford, England.~      All vaccinations will be administered intramuscularly. Three different doses will be tested~     (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).~      The total duration of the study will be 52 weeks from the day of enrolment for all~     volunteers.~   "
2293|NCT03027180|"~     Question: What level of noninvasive positive airway pressure is able to expand the lungs of~     people with pleural drainage? Design: Cross-sectional, experimental and randomized study.~     Participants: Four consecutive people with pleural effusion drained within 24 hours, with~     controlled pain and without contraindications to use of noninvasive positive pressure.~     Intervention: Each person will be randomly subjected to three levels of noninvasive positive~     airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography.~     Outcome measures: Lung area.~   "
2294|NCT03027167|"~     The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical~     compression devices versus aspirin alone for venous thromboprophylaxis following knee and~     hip arthroplasty.~   "
2295|NCT03027154|"~     In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases~     non-TB participants with lung disease who all meet the standard are divided into different~     groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10~     and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by~     blind method. Specific gama-interferon (γ-IFN) detection is needed before the~     injection.Measure the induration and (or) redness of longitudinal diameter size and~     transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At~     the same time, we observe all kind of adverse events in order to assess the safety of drug.~   "
2296|NCT03027141|"~     The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to~     investigate how a change in facial appearance is initially represented in brain circuits and~     then alters over time, as the new face becomes recognized as me.~      Investigators will try to identify areas of the brain responsible for processing and storing~     information about self-facial recognition; Examine how these areas of the brain respond to~     images of self and non-self and; Investigate how the brain responds, over time, to~     changes in facial recognition, particularly at time points: i) prior to facial injury, ii)~     post-injury but prior to facial transplantation, and iii) after receiving facial~     transplantation.~   "
2299|NCT03027102|"~     This study aims to determine the safety and toxicity of incremental doses of Double Negative~     T (DNT) cells in human subjects with high risk acute myeloid leukemia (AML). DNT cells are~     mature T lymphocytes that comprise ~1% of white blood cells in humans. Injection of DNTs~     from healthy donors has been demonstrated to be effective against AML cells. DNT cells will~     be collected from healthy volunteers and injected into patients.~   "
2300|NCT03027089|"~     Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)~   "
2301|NCT03027076|"~     This research is being done to learn more about the bacteria that live in the genito-urinary~     tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).~   "
2302|NCT03027063|"~     This research is being done to determine whether exercise while receiving doxorubicin or~     Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this~     treatment on the heart and improve other outcomes related to cancer such as tumor markers,~     nausea, fatigue and the ability to tolerate chemotherapy.~   "
2303|NCT03027050|"~     It was aimed to evaluate the contributions of T-PRF treatment combined with open flap~     debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis~     patients. 29 patients (58 sites) with chronic periodontitis were treated either with~     autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG~     ratio at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical~     parameters such as probing depth (PD), relative attachment level (RAL) and gingival margin~     level (GML) at baseline and 9 months after surgery were compromised.~   "
2304|NCT03027037|"~     This study, funded by the John Templeton Foundation, will examine birth and the early~     postpartum period (BEPP) as a transformative life experience that may shift women's~     experience of emotion in such ways as to a) support enhanced other-oriented emotions and b)~     underlie risk or resilience from psychopathology.~   "
2305|NCT03027024|"~     This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market~     clinical follow up study whereby patient undergoing routine cataract surgery will have~     bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority,~     Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The~     primary and secondary effectiveness data for visual acuity, defocus curves, contrast~     sensitivity and any adverse events will be collected.~   "
2306|NCT03027011|"~     This is a randomized controlled trial designed to test an intervention (Remote ischemic~     preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic~     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,~     cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to~     evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury~     in patients undergoing carotid endarterectomy compared to control intervention.The outcomes~     of interest include neurocognitive function,clinical outcomes,and biomarkers of brain~     injury.~   "
2307|NCT03026998|"~     The purpose of this study is to assess the benefit of MR screening for asymptomatic head &~     neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients~     previously treated by external beam radiation therapy (EBRT).~   "
2308|NCT03026985|"~     The purpose of this study is to describe the changes in quadriceps muscle size and quality~     over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound~     imaging. This study will also examine the relationship between those changes and muscle~     strength and level of physical function at day 10 and day 20 after ECMO commencement.~   "
2309|NCT03026972|"~     There are three populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried~     (AEC/BC02) phase I clinical research. The clinical study adopt randomized and open research~     design.~      Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD)~     skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative~     ;Population II have 75 subjects who received Tuberculin purified protein derivative(TB-PPD)~     and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection~     whose results are all negative.75 subjects whose three kinds of detection results are all~     positive(specific gamma interferon detection (γ-IFN),TB-PPD and ESAT6-CFP10 ) are named as~     population III. Three populations are screened at the same time.~      After filtrating, injecting of population I start firstly.After ensure the safety of the~     population I population II and population III carry out the implementation at the same time.~   "
2310|NCT03026959|"~     There is preliminary empirical support for the use of mindfulness interventions during the~     perinatal period; suggesting that mindfulness training may be an effective treatment~     approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety,~     stress, and psychological distress during the postpartum period. To extend on these~     findings, the purpose of this research is to evaluate the effectiveness of a brief~     mindfulness-based program in protecting maternal mental health and well-being using a~     randomized controlled trial.~   "
2311|NCT03026946|"~     The purpose of this study is to compare the efficacy of alitretinoin and cyclosporine in the~     treatment of patients with severe recurrent vesicular hand eczema.~   "
2312|NCT03026933|"~     To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.~   "
2313|NCT03026920|"~     It was reported that satisfactory postoperative outcome was difficult to obtain for the~     pelvic or acetabular fracture in old people. The less invasive surgical method was conducted~     in this study. Then, the clinical results were compared with the patients treated using~     traditional methods to assess the less invasive method.~   "
2314|NCT03026907|"~     The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the~     treatment of patients with severe chronic non-hyperkeratotic hand eczema.~   "
2315|NCT03026894|"~     To investigate the residual ridge resorption at anterior and posterior maxillary and~     posterior mandibular ridges among conventional complete dentures and implant overdenture~     wearers, and determine its association with the relative occlusal forces distribution,~     treatment groups and other patient variables.~   "
2344|NCT03026517|"~     The purpose of this study is to test whether it is safe to give phenformin with the standard~     drug combination of dabrafenib + trametinib. The combination of dabrafenib plus trametinib~     is a standard treatment for patients with metastatic melanoma whose melanoma has a mutation~     in a gene called BRAF.~   "
2316|NCT03026881|"~     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral~     selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the~     tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and~     to see how well this three drugs work together in the treatment of patients with recurrent~     and metastatic gastric cancer who progress following first-line therapy. The safety and~     efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.~   "
2317|NCT03026868|"~     The novel plate could be used to manage acetabular fractures involving quadrilateral surface~     and posterior column, which may lower the intraoperative blood loss and reduce complication~     rate.~   "
2318|NCT03026855|"~     The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection~     in combination with topical application of PRP gel in treating chronic or non-healing ulcers~     on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's~     bedside.~   "
2319|NCT03026842|"~     Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients~     with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients~     with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is~     the standard consolidation therapy for these patients with a 5-year overall survival~     approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for~     consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation,~     maintenance therapy is performed with conventional chemotherapy with a 5-year overall~     survival approximately 60% as well. However, continuous chemotherapy may cause toxicities~     and inhibit patients' immune response. Exploring new drug for maintenance therapy is~     urgently needed. Decitabine has a potent ability to inhibit proliferation and induce~     apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect~     of decitabine was also reported by several studies. In this study, the investigators plan to~     carry out a prospective, multicenter, randomized, controlled trail to compare decitabine~     versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21).~     Results of this trial may optimize the treatment for AML patients with t(8;21) in the~     setting of intermediate dose cytarabine consolidation.~   "
2320|NCT03026829|"~     The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy~     for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a~     combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief~     from Tinnitus (CART) firmware.~   "
2321|NCT03026816|"~     Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a~     new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic~     pain with established medical device platforms. The purpose of this study is to investigate~     and establish the use of SCS for volitional movement. Specifically, establishing the~     disinhibitory effect of SCS in a greater population with inherent greater variability.~      In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to~     explore the parameter space of the spinal cord stimulator platforms in order to optimize~     stimulation settings for patients through the creation of a clinical decision support system~     (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also~     begins to explore the effects of SCS on cardiovascular function, urinary function,~     psychiatric outcomes, and quality of life, which all offer significant potential for~     patients suffering from chronic spinal cord injury.~   "
2322|NCT03026803|"~     This phase II trial is studying how well giving oxaliplatin and capecitabine together works~     in treating patients with liver cancer.~   "
2323|NCT03026790|"~     Background and significance: Treatment with opioid pain medications (like hydrocodone and~     morphine) is common for severe pain, but studies show these medications may not always help~     and can cause serious problems. High daily doses of opioids can be especially unsafe. To~     help patients with chronic pain have better quality of life and avoid medication toxicity,~     health care teams need to manage pain while helping patients reduce opioid medication doses~     to safer levels.~      Study aims: This study will test which of two pain treatment strategies is better for~     managing pain and helping patients improve safety of opioid medication. For patients on high~     opioid doses who want to reduce, this study will also test whether offering an extra option~     for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine~     patients' and clinicians' experiences with the interventions.~      Study description: The study will compare two treatment strategies among patients with pain~     who are taking long-term opioid pain medications prescribed by VA healthcare facilities~     across the country. Patients who wish to enter the study will be assigned by chance to~     telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a~     pharmacist and supervising physician working together to find the best medication options~     for each individual patient. In IPT, a team of clinicians focuses on non-medication pain~     management options, in addition to pain medication.~      All participants will be asked to stay in the study for 12 months. Patients for whom it~     would be unsafe to participate will not be invited to join. With either treatment strategy,~     TCM or IPT, participants will have individualized pain care tailored to their needs and~     preferences. Participants on high opioid medication doses who want to reduce their opioid~     medication dose will be assigned by chance to get either a regular step-wise taper or a~     choice between a regular taper or switching to a different medication~     (buprenorphine-naloxone).~      At the end of the study, the two treatment strategies will be compared to see which worked~     better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes~     important to patients will also be tracked. These include quality of life, sleep, fatigue,~     depression, anxiety, and side effects.~   "
2324|NCT03026777|"~     Endotracheal intubation is common in the care of critically ill patients. Complications of~     airway management in this setting are frequently encountered and may be associated with an~     increased risk of death. The prevention of complications during urgent and emergent~     endotracheal intubation is a key focus for airway management research. Post-intubation~     hypotension (PIH), a common complication of endotracheal intubation in the critically ill,~     may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but~     this approach has not been examined in a prospective trial. There are no randomized trials~     of intravenous fluid administration to prevent PIH in critically ill adults. The~     investigators propose a randomized trial of fluid loading to prevent PIH in critically ill~     adults.~   "
2325|NCT03026764|"~     This study is a pragmatic randomized clinical trial comparing standard inpatient total hip~     arthroplasty with same day discharge. Patients who are medically well and have a good~     support structure at home will be randomized to inpatient or same day discharge. The~     investigators will compare patient costs from the perspective of the Ministry of Health, the~     institution, society and the patient. The investigators will also record complications,~     patient satisfaction, functional ability and quality of life.~   "
2345|NCT03026504|"~     This study will evaluate the safety and effectiveness of baricitinib in the treatment of~     giant cell arteritis. All participants will be taking prednisone at the start of the study.~     The prednisone will be reduced according to a standardized tapering schedule while~     participants continue to take one tablet of baricitinib daily for 52 weeks.~   "
2326|NCT03026751|"~     10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are~     for cytopenias.~      The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have~     mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence~     a panel of known MDS-associated genes in patient material (bone marrow and blood) that is~     sent routinely to the diagnostic service where conventional techniques have failed to~     establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to~     determine their survival, blood counts and development of acute leukaemia and other~     haematological malignancies. The clinical outcomes will be correlated with any mutations~     detected.~   "
2327|NCT03026738|"~     Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and~     Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of~     operative time, intraoperative blood loss , intraoperative organ injury, overall length of~     hospital stay, recurrence,and improvement of incontinence and constipation.~   "
2328|NCT03026725|"~     Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri~     calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity~     associated with At-Home vital tooth whitening using 20% carbamide peroxide~   "
2329|NCT03026712|"~     The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A~     stroke with involvement of motor function leads to a reduced excitability in affected~     hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might~     impair interhemispheric balance, leading to a decreased inhibition of contralesional~     hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of~     ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere~     hyperactivation in chronic phase after stroke is usually index of little functional recovery~     and is correlated with a greater ipsilateral structural damage.~      Robot-mediated physical therapy is an innovative rehabilitation technique that is effective~     in stroke patients. In this study, the investigators will add a non-invasive brain~     stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic~     treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique~     that is able to modulate cortical excitability. The hypothesis is that dual t-DCS~     (ipsilesional excitation and concomitant contralesional inhibition) could restore~     interhemispheric balance improving the benefits of robotic therapy with Armeo Power®.~   "
2330|NCT03026699|"~     The purpose of the study is to learn more about neuro-oncology caregivers' quality of life~     and how friends and families help neuro-oncology cancer caregivers at different times during~     treatment.~   "
2331|NCT03026686|"~     This is a retrospective chart review of women who labored and delivered in a single health~     care center. From that large group the investigators will evaluate women who were~     re-admitted in the post partum period for a hypertensive disorder. The study will also look~     at Controls, a group of women with similar risk factors but did not require readmission.~   "
2332|NCT03026673|"~     Chart review of women who have delivered an infant in a single health care system to~     determine if NSAID use increases blood pressures in the postpartum period.~   "
2333|NCT03026660|"~     The purpose of this study is to determine the effects of Moringa Oleifera on the structure~     and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily~     for 12 weeks.~   "
2334|NCT03026647|"~     Retrospective chart review evaluating different suture types on surgical outcomes for~     cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures~     are used.~   "
2335|NCT03026634|"~     Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart~     failure patients and the presence of sleep-disordered breathing has been associated with~     increased mortality. This study is designed to investigate prevalence and dynamics of~     sleep-disordered breathing in end-stage heart failure patients pre and post heart~     transplantation.~   "
2336|NCT03026621|"~     The purpose of this study is to determine whether or not 'Restore' lignite extract mineral~     supplement impacts the microbiome composition of the mouth and gut. Additionally,~     participant urine samples will be examined to determine whether or not 'Restore' mineral~     supplement impacts the composition urine biomarkers and toxins.~   "
2337|NCT03026608|"~     The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce~     market on access to healthy food and fruit and vegetable intake in 12 lower-income~     communities using a cluster-randomized design.~   "
2338|NCT03026595|"~     Depression is considered to be the most common neuropsychiatric disturbance of PD. In this~     study, investigators will summarize the treatment profile of PD depression to see if PD~     depression is properly treated according to guideline.~   "
2339|NCT03026582|"~     Objectives: To assess the predictive value of IUS in children with IBD.~      Design: A prospective longitudinal cohort study.~      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's~     Hospital.~      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with~     either CD or UC.~      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year~     follow-up according to therapeutic regimen.~      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,~     serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other~     radiologic measures performed as part of routine care.~   "
2340|NCT03026569|"~     This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C,~     may contribute to the treatment of patients with chronic hepatitis C.~   "
2341|NCT03026556|"~     The purpose of this study is to assess the safety and effectiveness of newly initiated~     dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in~     comparison to newly initiated rivaroxaban users and newly initiated apixaban users~   "
2342|NCT03026543|"~     This prospective, blinded, randomized clinical trial investigates the effect on~     postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a~     laparoscopic cholecystectomy.~   "
2343|NCT03026530|"~     The purpose of this prospective, blinded, randomized clinical trial is to investigate~     whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce~     overall postoperative pain and nausea.~   "
16423|NCT02842346|"~     The aim of our study was to investigate the correlation between the umbilical resistance~     index and weight gain during the third trimester of low-risk pregnancies.~   "
2346|NCT03026491|"~     The investigators aim to evaluate chewing function in children with repaired esophageal~     atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated~     for age, sex, type of atresia. Each child will be required to bite and chew a standardized~     biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale~     (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to~     determine the tolerated food texture of children.~   "
2347|NCT03026478|"~     Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease~     characterized by pain and burning sensation. The major types of OLP are the following:~     reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains~     unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of~     autoimmunity. Numerous treatment options of OLP include topical and systemic agents~     depending on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and~     are widely accepted as the primary treatment of choice.Hence this study is designed to~     evaluate and compare the clinical efficacy of topical Clobetasol 0.05% in orabase and~     Betamethasone 0.05% in orabase in combination with Clotrimazole 1% in the management of~     symptomatic Oral Lichen Planus.~   "
2348|NCT03026465|"~     The objective of the present study is to determine the relation between vascular injury~     induced by the stent and strut thickness.~   "
2349|NCT03026452|"~     To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation~     for liver tumors, the investigators used preoperative and postoperative~     US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests~     including the tumor markers to evaluate the general condition of patients. Intraoperative~     US/CEUS/CT would be applied to monitor ablation lesions.~   "
2350|NCT03026439|"~     The aim of this study is to determine if presence of dyspnea identifies differences in the~     6-min walk test performance among smokers with normal or mild spirometric obstruction,~     accounting for the confounding effect of heart failure on dyspnea with stress~     echocardiography.~   "
2351|NCT03026426|"~     Background: Depression is a common comorbidity of physical chronic diseases such as diabetes~     and/or hypertension and constitutes an important public health problem. It correlates~     negatively with the patients' quality of life and self-care, as well as compliance with~     medical treatment. In low- and middle-income countries depression often goes unrecognized~     and untreated, and there are limited human resources to treat depression and other mental~     problems.~      Aim: The present study aims to test a 6-week low-intensity psychological intervention~     (CONEMO - CONtrol EMOcional) delivered by a smartphone application to people with depressive~     symptoms and co-morbid diabetes and/or hypertension recruited in primary health care centers~     and public hospitals in Lima, Peru.~   "
2352|NCT03026413|"~     To compare the efficacy and safety of circumferential pulmonary vein isolation without~     contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial~     fibrillation.~   "
2353|NCT03026400|"~     While some studies have suggested that subumbilical and transumbilical incisions have a~     similar clinical efficiency and safety, no study has yet evaluated their respective impact~     on patient's postoperative aesthetic satisfaction.~      The objective of this randomised trial is to compare patient's postoperative aesthetic~     satisfaction depending on the type of incision which is performed during surgeries.~   "
2354|NCT03026387|"~     Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides~     (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated~     by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime~     SA. In addition, SBs are common among young people and are the second leading cause of death~     among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of~     predictive models. These are currently imprecise and prevent the development of consensual~     recommendations for the management of suicidal patients.~      Most suicide attempters are evaluated in the emergency room where it is imperative to~     identify people with a high risk of relapse. Risk assessment is generally based on the~     experience of the practitioner who uses psychometric scales as support for clinical~     decisions. This assessment could be improved and supplemented by other sources of~     information. Thus, we aim to develop a short and specific tool that combines:~        1. Neurocognitive measures carried out using computer software on domains strongly~          associated with SB: impulsivity, affective dysregulation, alterations in~          decision-making (risky choices), selective attention and verbal fluency.~        2. Clinical and psychological assessment including the most predictive items of future SA:~          life events (environment) and personality traits (vulnerability). Suicide attempters~          will be assessed for SB and suicidal ideation in the emergency department. These~          measures will be repeated during a 12-month follow-up. We will use the data obtained to~          provide a more accurate measure of risk.~   "
2355|NCT03026374|"~     Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new~     malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with~     breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide.~     Additionally, 30% of early breast cancer turns metastatic, which is often incurable.~     Different from women with early breast cancer, women with metastatic breast cancer(MBC)must~     receive lifelong treatment, experience higher levels of emotional/physical distress, and~     feel frequent uncertainty about their health/possible death. They are also challenged to~     manage distressing adverse effects induced by different adjuvant treatments and experience~     heavy self-care demands during the transition period from being a patient to being a~     survivor. Thus, specific interventions to help women with metastatic breast cancer to~     recover from this traumatic event have been designed, and one of these is~     supportive-expressive group therapy(SEGT).SEGT has been found to achieve improvement in~     anxiety, depression, quality of life (QoL), family functioning, and satisfaction with~     treatment. However, the effect of SEGT on survival is inconsistent. Initial studies~     examining SEGT have reported a mean survival advantage of 18 months, however, these findings~     could not later be replicated.Yet, no study has reported a survival disadvantage for those~     given SEGT. In addition, we found no published articles on the application of SEGT among~     women with MBC in China. Owing to this dearth of previous research, it is unclear whether~     this therapy would exhibit positive effects within Chinese culture. Thus, we developed a Be~     Resilient to Breast Cancer(BRBC) program that is culturally tailored for Chinese females~     with MBC. This program was adapted from SEGT and is designed to increase resilience(defined~     as the capacity to bounce back after encountering a traumatic event) and QoL, decrease~     emotional and physical distress(allostatic load), and eventually prolong longevity. To~     better adapt to Chinese culture, we added education hosted by professional staff (e.g.,~     clinical psychologists, dietician, Chinese medicine practitioner, etc.)in an effort to~     foster self-efficacy to combat symptoms (such as pain, fatigue, intrusive thoughts, etc.)~     through knowledge and technics (such as breath control, meditation, etc.),and to help~     patients gain a sense of control in their life. Second, trained mentors, who were breast~     cancer survivors themselves, were added to the group discussion to create non-hierarchical,~     reciprocal relationships through the sharing of experiences with those facing similar~     challenges. These mentors also provided women with first-hand information about treatment~     and offered suggestions to combat barriers to recovery.~   "
2356|NCT03026361|"~     The aim of this study was to examine molecular alterations on the protein level in lesions~     of oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global~     protein profiling methods based on liquid chromatography coupled to mass spectrometry were~     used, with a special emphasis on evaluation of deregulated extracellular matrix molecules~     expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like~     growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by~     comparative semiquantitative immunohistochemistry.~      Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and~     accompanied histologically unaltered tissues, respectively) identified 55 extracellular~     matrix proteins. Twenty among identified proteins were common to all groups of samples.~     Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to~     IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a~     negative regulator of IGF2 activity.~   "
2357|NCT03026348|"~     This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300~     eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into~     multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will~     be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions~     of subjects in various strata will not be pre-specified and the goal will be to achieve an~     approximately equal distribution of subjects with these characteristics across the treatment~     groups. Serology measures consistent with the study outcomes will be reported.~   "
2358|NCT03026335|"~     The purpose of the study is to use existing school resources and improve identification,~     referral and local support for children that exhibit exposure to childhood trauma resulting~     from environmental violence in Belize City. The Ministry of Education has identified the~     goals of the project to reduce violent behaviors in primary school children and supporting~     those children that have been exposed to violence or other malicious behavior that would~     inhibit normal school functioning. In addition, the MOE is supporting additional resources~     and data collection for a comprehensive evaluation of student behavior and academic~     performance.~   "
2359|NCT03026322|"~     Complications are common during endotracheal intubation of critically ill adults. Manual~     ventilation between induction and intubation (bag-valve-mask ventilation) has been~     proposed as a means of preventing hypoxemia, the most common complication of intubation~     outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a~     randomized trial comparing manual ventilation between induction and laryngoscopy to no~     manual ventilation between induction an laryngoscopy during endotracheal intubation of~     critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen~     saturation. The primary safety endpoints will be the lowest oxygen saturation, highest~     fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours~     after the procedure.~   "
2360|NCT03026309|"~     Main objectives: Comparing levels of F-DOPA reuptake rate as an indicator for Dopamine~     metabolism of un-medicated Depressed patients to healthy individuals in the~     Mesocorticolimbic System (VTA-NAc-PFC) and assessing structural differences between the two~     groups in the Hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic System~     (VTA-NAc-PFC) and resting state fMRI.~      Secondary objectives: 1. Comparing the differences of DNA Methylation in the plasma and~     serum of patients compared to healthy controls. 2.Assessing the correlation between~     symptoms' severity score (evaluated based on Hamilton Rating Scale) at base line and 6~     months following treatmnt to PET 18F-DOPA uptake repertoire in the Mesocorticolimbic System,~     structural measurements and DNA Methylation.~      Methodology: Study Design: A prospective, pilot study. 30 un medicated Depressed patients~     and 30 Healthy volunteers will perform a [18F] FDOPA PET/MRI scans following a HAM-D~     questionnaire (Hamilton rating scale of depression) and blood tests.~      PET-MR (Biograph mMR, Siemens AG, Erlangen, Germany) scans will be performed using the~     tracer of dopamine precursor 3,4-dihydroxy-6-[18F]-fluoro-l-phenylalanine ([18F] FDOPA) that~     reflects L-dopa transport, L-aromatic amino acid decarboxylase activity, vesicular uptake~     and the number of dopamine nerve terminals. Measurements of dynamic F-DOPA parameters (Ki)~     and quantitative measurements of static F-DOPA ( SUVmax and SUVmean) will be performed in~     the ventral tagmental area (VTA), nucleus accombens (NAc) and pre-frontal cortex (PFC)which~     comprise the Mesocorticolimbic System, bilaterally. MRI sequences of T1, T2 3D measurements~     (assessing Volume) of the hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic~     system, DTI measurements in the mesocorticolimbic dopaminergic tract and BOLD (resting-state~     f-MRI) in those brain networks. whole genome DNA Methylation from whole blood will be~     performed.~      To date there is no quantative standard of care evaluation tool that serves psychiatrists~     when assigning medication for newly diagnosed depressed patients. The manner in which~     medications are assigned are threw symptom evaluation and trial and error. Only a third of~     the patients achieve remission after the first line of treatment. SSRI's are most common~     type of medication used to treat Major Depression today. One third of patients remains un~     responsive even after the fourth line of treatment (of different types of medications). Anti~     depression medications way of action requires time to reach its effect and in many patients~     with no avail or even causing symptom's severity. The PET-MR multimodality imaging tool~     offers a cutting edge technology ideally fitted to measure brain disorders. The use of~     F-DOPA radio-ligand with the PET-MR constitutes a novelty in the imaging of the depressed~     brain. Dopamine is one of three of the monoamine neurotransmitters targeted by~     anti-depressive medication, sharing metabolistic agents. dopamine has been proven to be~     connected to the processing of emotion, motivation, hedonism and reward threw its action in~     the Meso-cortico-limbic system. Epigenetics is a regulatory system that determines gene~     expression. It is heritable in the one hand and reacts to environmental changes on the~     other. It has been shown to be involved in psychiatric disorders.~      PET-MR scans will be performed. DNA samples will be extracted from subject's whole blood~     samples taken prior to scans. Then it will be analyzed for whole genome DNA methylation.~     Taken together this novelty imaging technique and epigenetic mapping of peripheral markers~     can be used to better understand and personalize anti-depressive treatment compatibility.~   "
2361|NCT03026296|"~     A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service~     providing lifestyle support programs for physical activity, smoking cessation and diet, to~     inhabitants with increased risk for development of non-communicable diseases. HLCs intention~     is to reach physically inactive people who need guidance to get more physically active, and~     offer them a lifestyle program for three months or more.~      The main aim of this study is to study whether the HLCs, organized according to the~     Norwegian Directorate of Health`s guidelines for municipal healthy life centers, affects the~     participants short term (3 months) and long term (15 months) physical activity level. Also~     changes in diet, tobacco use, health related quality of life, physical fitness,~     anthropometry, self-efficacy, motivation, drug use, use of health services and work~     participation will be assessed. Secondary aim is to study whether there are any moderators,~     such as HLCs capacity, expertise, and collaboration with other services, that have~     significance for participants' change. Also it will be studied whether the HLCs result in~     larger changes in some subgroups (e.g. socioeconomic) of participants than in others.~   "
2362|NCT03026283|"~     Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has~     high sensitivity and negative predictive value for the detection of coronary artery disease~     (CAD). The main limitations of CCTA are its poor specificity and positive predictive value,~     as well as its inherent lack of physiologically relevant data on hemodynamic significance of~     coronary stenosis, a data that is provided either by non-invasive stress tests such as~     myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow~     Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard~     CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging~     (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary~     purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in~     triaging chest pain patients in outpatient settings who are found to have obstructive CAD~     upon CCTA (> 30% and < 90% stenosis). Invasive FFR and short term clinical outcomes (90~     days) will be correlated with each diagnostic modality in order to evaluate positive and~     negative predictive value of each when used incrementally with CCTA.~      Patients will undergo a CCTA, as part of routine care. If the patient consents to~     participate in the study and is found to have coronary stenosis of 30% to 90%, based on the~     cardiologist's reading, the CCTA study will be sent to HeartFlow, a vendor that will provide~     a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis~     indicates obstructive disease, the patient will undergo cardiac catheterization with~     invasive FFR.~      As CCTA utilization increases, the need to train additional imaging specialists will~     increase. This study will assess the capability of FFR-CT to enhance performance on both~     negative and positive predictive value for less experienced readers by providing feedback~     based on CT-FFR evaluation. CCTA readers will be grouped in two categories: those with more~     than 10 years reading experience and those with less than 10 years reading experience. Each~     CCTA will be read by a less experienced and a more experienced reader. Results from each~     reader will be correlated with each other and with the CT-FFR and invasive FFR results.~   "
2363|NCT03026270|"~     Effect of therapeutical paraffin wax bath in the malleability of burned skin~   "
2364|NCT03026257|"~     The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses~     cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the~     control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual~     multi-purpose solution (MPS) for cholesterol uptake.~   "
2365|NCT03026244|"~     Rationale: The immune system in the ageing population becomes compromised with age (termed~     Immunosenescence). Therefore, elderly people have a decreased ability to respond to~     infection and vaccination. Furthermore, many of the health issues associated with ageing are~     linked to inflammation (Inflammaging). It has been suggested that this compromised immune~     function is in part due to reduced Toll-like receptor (TLR) function, which is part of the~     innate immune system. Milk and dairy based products have been shown to have beneficial~     effects on inflammation and immunity. This effect may be mediated via support of the innate~     immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).~     Also prebiotics have been suggested to influence markers of innate immune function.~     Furthermore, TLR function has been suggested to be correlated to vitamin D status.~     Therefore, in the current pilot study, the potential of milk protein, prebiotics and vitamin~     D to support innate immune function in elderly will be investigated.~      Objective: Aim of the current study is to evaluate the effect of milk protein on the innate~     immune response in elderly in a pilot study. Furthermore, support of this effect by~     prebiotics and Vitamin D will be studied.~      Study design: The study will be a double-blind placebo-controlled pilot study. Study~     population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1:~     Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk~     protein + prebiotics + Vitamin D or placebo.~   "
2366|NCT03026231|"~     The purpose of this study is to characterize the intestinal flora in subjects with~     Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of~     colonic microbiome following fecal microbiota transplantation.~   "
2391|NCT03025906|"~     Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency,~     evidence-based data to guide initial drug treatment choices are lacking in the Chinese~     population. The investigators conducted this prospective randomized controlled trial to~     evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and~     valproate (VPA) in patients with GCSE.~   "
3128|NCT03016260|"~     RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with~     rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate~     combination therapy.~   "
2367|NCT03026218|"~     A critical variation in the provision of prenatal care to women with GDM is the need to keep~     patients engaged with their care between visits by tracking glucose levels using finger~     sticks and making dietary and other lifestyle modifications to keep these levels at or close~     to normal. Multiple studies have demonstrated that the use of mobile devices can improve~     medical outcomes. In order to keep patients engaged between appointments and improve~     self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition~     therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with~     GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give~     the user positive feedback and rewards for using the system. This model of group care with~     mobile phone monitoring and reminders for women with GDM has not been previously studied. A~     randomized control trial is purposed to determine if this approach improves patient care.~     The investigators hypothesize that group prenatal care along with inter-session mobile~     therapy will increase dietary compliance and therefore reduce the number of individuals~     requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group~     prenatal care (GPC) will provide a community foundation to improve learning and increase the~     motivation of patients to learn and change. This motivation will be further strengthened by~     the use of the GlucoseMama monitoring system which will provide each patient with glucose~     tracking and individualized nutritional support.~   "
2368|NCT03026205|"~     This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that~     incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three~     sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a~     repeat pharmacokinetic study during the final oral dose administered as the first dose on~     day 7 to ascertain CPC accumulation.~   "
2369|NCT03026192|"~     Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in~     preterm infants after completing medical treatment for a hemodynamically significant PDA.~   "
2370|NCT03026179|"~     To determine if a brief primary care intervention can educate under-resourced and minority~     parents about discipline in a way that is culturally sensitive.~   "
2371|NCT03026166|"~     The purpose of this multicenter, Phase 1/2, open-label, study is to assess the safety and~     efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab~     and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).~   "
2372|NCT03026153|"~     Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic~     condition that impairs quality of life as much or more than other major medical conditions.~     Biopharmaceuticals are medications which are are isolated from biological sources including~     microorganisms, animals or humans. These medications generally function to decrease~     inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about~     choosing a biologic medication over other options due to anxiety regarding the need for~     regular injections, leaving the patient undertreated and continuing to suffer with~     psoriasis. Reducing fears of injections may improve adherence to treatment and may improve~     treatment outcomes. Fear of injection is inherently subjective and may be easily modified.~     Anchoring is the tendency for humans to rely on a specific value when making decisions and~     to make judgments relative to that value. Patients who have never taken an injection will~     subjectively view the idea of taking an injection relative to the not taking any injection~     baseline. This comparison is scary and represents a considerable hurdle to taking a new~     injectable medication that may be otherwise optimal for their treatment. Resetting the~     anchor may be all that is needed to help patients overcome fear of injection. The objective~     is to assess whether patients offered a once monthly injectable biologic would be more~     likely to accept that biologic medication if they are first counseled about a daily~     injection.~   "
2373|NCT03026140|"~     In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs~     of distant metastases will be treated with short-term immunotherapy + COX2-inhibitors. This~     treatment will be given during the window period until surgical resection of the tumor. The~     duration of treatment will be approximately 6 weeks.~   "
2374|NCT03026127|"~     The goal of this project is to refine and test a novel emotion-regulation based psychosocial~     intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years~     old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal~     ideation or suicide attempt). Suicide rates in this group are alarmingly high, and reducing~     suicide rates in at-risk populations is a major NIMH priority.~   "
2375|NCT03026114|"~     The TURKHEF registry is the one of the first to include a large sample of patients with HF~     from different regions in Turkey. To describe the demographic, clinical, and~     echocardiographic characteristics and management of outpatients with Heart Failure (HF)~     followed by a representative setting of cardiology centres. Scarce data are available in the~     middle-east populations in general and Turkish patients in particular, who have different~     etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The~     aim of this study was to study Turkish patients with HF, and define their clinical~     characteristics and the signs and symptoms of heart failure, echocardiographic findings and~     medications at admission. With this national study, we will evaluate how recommendations of~     most recent European guidelines regarding pharmacological and non-pharmacological treatments~     are adopted in clinical practice. We will also evaluate the prevalence of the clinical~     profiles of patients with HF, according to the definitions proposed by the European Society~     of Cardiology, and to investigate their appropriateness in characterizing patients with~     different clinical presentations and needs. Assessed outcomes included the causes of~     decompensation, use of medications, care quality indicators. Clinical Characteristics and~     Management of TURKish Adult Outpatients With HEart Failure (TURKHEF) study aims to~     characterize baseline characteristics of patients with heart failure in Turkey.~   "
2392|NCT03025893|"~     In this study the investigators will evaluate the effect of high-dose, intermittent~     sunitinib versus treatment with lomustine in patients with recurrent glioblastoma~     multiforme. The investigators hypothesize that sunitinib, when given in a high-dose,~     intermittent schedule, will achieve adequate concentration levels in the tumor and will,~     besides its anti-angiogenic properties, inhibit gliomagenesis by inhibition of multiple~     kinases.~   "
3898|NCT03006185|"~     Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser~     versus microdermabrasion combined with large-area photodynamic therapy with methyl~     aminolevulinate for actinic keratoses~   "
2376|NCT03026101|"~     Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males.~     Emergency room visits, physician consults, hospitalizations, medications, and indirect costs~     such as lost work days and decreased productivity place the global economic burden of~     migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone.~     Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea,~     vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced~     functionability, have lost time at work, and 1/3 of patients require bed rest to manage the~     symptoms. The health-related impact on quality of life was comparable with that experienced~     by patients with congestive heart failure, hypertension, or diabetes.~      While the burden of migraines on our society is clear, the pathophysiology of migraines~     remains largely unknown. The trigeminovascular system, including the external and internal~     carotid arteries and their associated sensory fibers which subserve the head have long been~     implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in~     1953, was the first to posit that migraine headache pain is the caused by dilation or~     circumferential expansion of the extracranial carotid artery. He demonstrated that~     migraineurs had twice the pulse amplitude in their external carotid arteries compared to~     control subjects and these changes were directly correlated to migraine symptoms. In a 2008~     study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20~     minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent~     dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and~     transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels.~     Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it~     is a selective extracranial vessel constrictor which does not cross the blood brain barrier.~      The goal of this current work is to utilize the direct, real-time angiography, which~     provides a high resolution map of vasculature, and demonstrate changes in vessel flow in~     patients who have migraine headache attacks. This information may guide therapeutic~     interventions in the future in order to better treat these migraine patients.~   "
2377|NCT03026088|"~     This is a single-arm, open label, interventional, multi-center, phase IV pilot study.~   "
2378|NCT03026075|"~     The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating~     the performance and safety of a colon cleansing device during a colonoscopy procedure in a~     poorly prepared colons.~      Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in~     the Netherlands).~      Subjects who meet the eligibility criteria will be screened for study participation at a~     baseline visit(visit 1). Subject who is eligible to the study will required to follow a~     specific preparation instruction starting 2 days prior to the colonoscopy with the Motus~     Cleansing System (MCS) procedure.~      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and~     14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse~     Events (AE).~   "
2379|NCT03026062|"~     The goal of this clinical research study is to test 2 types of dosing schedules of~     tremelimumab and durvalumab to learn if one is more effective in patients with high-grade,~     platinum-resistant epithelial ovarian, peritoneal, or fallopian tube cancer. The safety of~     the dosing schedules will also be studied.~   "
2380|NCT03026049|"~     Patients will be randomised between deep venous stenting or conservative management~   "
2381|NCT03026036|"~     This study investigates stress-related signaling of glutamate and dopamine within the~     reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used~     to predict depressive symptoms in the future. This will be achieved through various~     neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.~   "
2382|NCT03026023|"~     This is a proof of concept, single center study for the donation of HCV-positive hearts to~     HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks~     of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon~     transplantation.~   "
2383|NCT03026010|"~     The aim of the study is to check standard screening blood pressure in the arm and central~     blood pressure, the blood pressure at the heart in pregnant women. The standard brachial~     pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to~     distinguish preeclampsia from other types of hypertension or to predict preeclampsia in~     those at risk. Central aortic pressure monitoring has become a valuable clinical tool and~     preliminary studies suggest that measuring of central blood pressure may be better predictor~     of preeclampsia. It is non invasive and doesn't require undressing. It involves using a~     standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure~     with an ultrasound and taking measurements of the person neck to torso. With this knowledge~     it will be a useful screening tool to identify these patients at higher risk and hopefully~     lead to closer monitoring, earlier treatment and reduced morbidity and mortality~   "
2384|NCT03025997|"~     This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt~     snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject~     receives two treatments (active, and placebo) on two different days, following a randomized~     cross-over design.~   "
2385|NCT03025984|"~     Diabetes is a common complication of pregnancy that increases risks for both the mother and~     baby. Poorly controlled diabetes has been associated with very large babies, congenital~     heart defects, stillbirth, birth trauma, and maternal infections among other complications.~     Patients with diabetes in pregnancy require more frequent prenatal visits and fetal~     evaluation, and must shoulder the burden of mastering management of a complicated care~     regimen. With the ever-expanding world of technology, more healthcare practices are using~     cell phones, texting, and social media to interact with patients. Use of this technology has~     been successful in management of chronic diseases and as reminder systems. The investigators~     propose a randomized clinical trial to investigate patient adherence to recommended care~     regimen after intervention of a text message reminder and education system.~   "
2386|NCT03025971|"~     A prospective, multicenter, nonrandomized, single-arm, controlled target value study,~     designed to include no less than 82 patients in at least two (2) clinical centers in China.~   "
2387|NCT03025958|"~     Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced~     Nasopharyngeal Carcinoma~   "
2388|NCT03025945|"~     Prospective, randomized, double-masked, placebo-controlled clinical study to define the~     effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use~     after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular~     edema.~   "
2389|NCT03025932|"~     Patients who underwent laparoscopic repair of large hiatal hernias and anterior~     fundoplication with mesh are examined for their recurrence rate one year after surgery.~   "
2390|NCT03025919|"~     Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in~     diabetes screening in Chinese natural population~   "
2393|NCT03025880|"~     Study Design and Treatment:~      This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate~     the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with~     HER2-negative ABC that have previously received anthracyclines and taxanes (unless~     clinically contraindicated). In hormone receptor positive patients, previous treatment with~     2 or more lines of hormone therapy will also be required. Patients must have at least one~     measurable lesion that can be accurately assessed at baseline and is suitable for repeated~     assessment by CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65~     patients depending on the results of the run-in-phase) will be included in this trial.~   "
2394|NCT03025867|"~     This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian~     Cancer.~      This program is designed to provide access to niraparib prior to approval by the US Food and~     Drug Administration (FDA).~      To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete~     response (CR) to their most recent platinum-based chemotherapy and must have experienced a~     PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6~     months without disease progression after this chemotherapy.~   "
2395|NCT03025854|"~     The purpose of this clinical research project is to explore potential biomarkers and~     validate the predictive and prognostic value of molecular signature in nasopharyngeal~     carcinoma.~   "
2396|NCT03025841|"~     Pneumonia is the most frequent infection in critically ill patients and remains a~     significant challenge to intensivists world-wide due to persisting high mortality and~     morbidity. Compelling evidence suggests that appropriate antibiotic therapy remains the most~     important intervention to improve patients' outcome, including the administration of a~     suitable molecule at an optimized dosage regimen. A vast array of pathophysiological changes~     can occur in critically ill patients that can complicate antibiotic dosing. Knowledge of the~     pharmacokinetic and pharmacodynamic properties of the antibiotics used for the management of~     critically ill patients is essential for selecting the antibiotic dosing regimens, which~     will optimize patient outcomes. Changes in volume of distribution (Vd) and clearance (CL) of~     antibiotics have been noted in these patients, which may affect the antibiotic concentration~     at the target site. It follows that the pharmacodynamic parameters that determine antibiotic~     efficacy, which can vary between antibiotic classes, may also be affected. Optimization of~     these parameters is necessary to maximize the rate of response through patient recovery and~     minimized antibiotic resistance.~      In a multicenter observational study in critically ill patients with normal plasma renal~     indices at admission, about 65% of patients manifested augmented creatinine clearance on at~     least one occasion in the first seven study days. Augmented creatinine clearance may~     significantly impact drug pharmacokinetics for a variety of renally eliminated~     pharmaceuticals (such as low-molecular weight heparins, aminoglycosides, glycopeptides, and~     β-lactams), leading to subtherapeutic concentrations and potentially adverse clinical~     outcomes. Currently little data exist that describe the consequences of augmented creatinine~     clearance on antibiotics PK.~      Ceftaroline (600 mg bid) is a cephalosporin with expanded gram-positive activity, including~     MRSA and penicillin-resistant streptococcus, which was approved by the US Food and Drug~     Administration (FDA) on October 29, 2010 for the treatment of acute bacterial SSSIs and~     community-acquired bacterial pneumonia. Ceftaroline showed also good activity against some~     of the common gram-negative respiratory pathogens (eg, Haemophilus influenzae, Moraxella~     catarrhalis, Neisseria meningitidis, and Pasteurella multocida). However, it does not~     display clinically relevant activity against Pseudomonas aeruginosa, Stenotrophomonas~     maltophilia, or Acinetobacter baumannii. Ceftaroline also lacks activity against~     gram-negative organisms with extended-spectrum β-lactamases. Importantly, because~     ceftaroline appears to induce AmpC β-lactamases despite MIC values in susceptible range,~     ittheoretically should be avoided in gram-negative bacteria known to harbor inducible AmpC~     β-lactamases (eg, Serratia, Proteus, Citrobacter, Morganella, Enterobacter, Providencia, and~     P. aeruginosa). In patients, ceftaroline is given as a prodrug, ceftaroline fosamil. After~     intravenous administration, the prodrug is rapidly transformed by plasma phosphatase enzymes~     to its bioactive metabolite. The pharmacokinetics of ceftaroline has been evaluated in~     single and multiple dose studies in healthy volunteers, in subjects with various degrees of~     renal impairment and in healthy elderly subjects. The volume of distribution is equal to~     20.3 L, which corresponds to extracellular fluid volume. The protein binding is low (20%).~     The main route of elimination is via renal excretion, with a clearance estimated to160~     mL/min close to the creatinine clearance. The elimination half-live is 2.6 h in adults with~     normal renal function. Unfortunately, no PK study has been performed in infected critically~     ill patients with augmented creatinine clearance. The best PK-PD index predicting drug~     efficacy is %Time>CMI. A bacteriostatic effect is achieved when free drug concentrations~     exceed the MIC for 30 to 40% of the dose administration interval (30 to 40%T>MIC). Near~     maximum organism kill is achieved at 50 to 60%T>MIC (30%T>MIC for Staphylococcus aureus).~      This project aims to characterize ceftaroline PK in patients with early-onset pneumonia and~     augmented creatinine clearance. The choice of ceftaroline is justified by its spectrum~     suitable for micro-organisms commonly encountered in early onset pneumonia, including~     methicillin-resistant Staphylococcus aureus. Secondary main objective is to predict the~     probably of reaching PK-PD targets using Monte Carlo simulations under various scenario in~     order to identify optimal ceftaroline administration schemes in critical care patients with~     various degrees of renal impairment.~   "
2397|NCT03025828|"~     The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,~     Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous~     nephropathy. Acthar is a hormone that stimulates steroid production from small glands above~     the kidneys. It has direct protective effects on the kidney and is currently approved by the~     FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of~     action are not entirely understood and will be studied in the present trial.~   "
2398|NCT03025815|"~     The purpose of this study is to determine whether oral stimulation program are effective to~     improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized~     classification of the subjects into to experimental and a control group.~   "
2399|NCT03025802|"~     The FAPIC project will develop a diagnostic system that will identify pathogens and~     charachterize virulence and resistance. A prospective study will be performed in which blood~     samples will be collected of patients with suspected sepsis in order to evaluate the~     diagnostic system. In routine care, blood is drawn of these patients for culture in order to~     identify the causative pathogen. This process takes 3-5 days. During the study, one extra~     blood sample will be collected with the same venipuncture, with each blood culture.~     Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to~     the research laboratories for determination of sensitivity and specificity. The system will~     not be used in the clinic.~   "
2400|NCT03025789|"~     This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT~     at all stages of the disease. The aim of the present study is to provide additional~     information on the effectiveness and safety of fexinidazole and to assess its use under~     conditions as close as possible to those in real life, both in patients treated on an~     out-patient basis and in the hospital setting, depending on clinical status~   "
2401|NCT03025776|"~     To further develop interventions, the investigators need a better understanding of which~     task requirements (i.e. size or weight of object, location in workspace, etc.) drive a~     person after stroke to use 2 hands (as opposed to 1), and how the severity of their injury~     impacts this relationship. A better understanding of this relationship will promote more~     informed development of rehabilitative interventions. This study proposes to explore in~     people after stroke: i.) how specific functional tasks requirements relate to 1 vs. 2 handed~     use, and ii.) how stroke severity impacts this arm use. We are proposing to study 15~     individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour~     session of task-related reaching in sitting . The investigators will systematically vary~     task requirements (i.e. object size or weight, location in workspace, etc.), and record use~     of 1 versus 2 hands using videotaping as well as recording of quality of arm movement~     (kinematics) and muscle activity (EMG) in both arms.~   "
2402|NCT03025763|"~     Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in~     which the sutures between skull bones close too early, causing long-term problems with brain~     and skull growth. Infants with CS typically require extensive surgical treatment and may~     experience many perioperative complications, including hemorrhage and re-synostosis. Even~     with successful surgery, children can experience developmental and learning disabilities or~     vision problems. Most often, CS appears as isolated nonsyndromic CS (NSC). Of the several~     subtypes of CS, unilateral or bilateral fusion of the coronal suture is the second most~     common form of CS accounting for 20-30% of all NSC cases. The etiology of coronal NSC (cNSC)~     is not well understood, although the published literature suggests that it is a~     multifactorial condition. About 5-14% of coronal craniosynostosis patients have a positive~     family history, with a specific genetic etiology identified in >25% of cNSC cases,~     suggesting a strong genetic component in the pathogenesis of this birth defect. The causes~     for cNSC and its phenotypic heterogeneity remain largely unknown. An international team of~     investigators will generate large genomic and gene expression datasets on samples from~     patients with cNSC. State-of-the-art imaging, genetic, and developmental and systems biology~     approaches will be used to quantitatively model novel pathways and networks involved in the~     development of cNSC. Novel variant-, gene- and network-level analyses will be performed on~     the genomic data obtained from cNSC cases, their relatives, and controls to identify novel~     variants and genetic regions associated with cNCS. Quantitative, analytical, and functional~     validations of these predictions will provide insights into the etiology and possible~     therapeutic targets for CS and potentially other bone-related disorders.~   "
2403|NCT03025750|"~     The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled,~     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and~     IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.~   "
2404|NCT03025737|"~     The aim of the present proposal is to investigate the development of distinct morphological,~     functional, biochemical and molecular aspects of short- and long-term sport-induced changes~     in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The~     main goal of our research is to deepen our knowledge on the proper differentiation between~     beneficial (physiological) and harmful (pathological) consequences of professional sport,~     thereby effectively preventing potential cardiovascular complications of athletes.~   "
3236|NCT03014856|"~     This study provides a sound basis towards a better understanding of the biochemical~     mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great~     importance towards the development of more personalized prevention and treatment in future.~   "
2405|NCT03025724|"~     This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment~     of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for~     treating SCCis. This study will also secondarily evaluate the tolerability of using~     photodynamic therapy for treatment of SCCis.~      Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria~     include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction~     to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue~     light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6~     skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to~     porphyrins.~      Age, gender, size, and location of the SCCis will be recorded. All subjects will receive~     surgical treatment of their SCCis. The control group will undergo a surgical excision of the~     tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The~     intervention group will receive PDT plus surgical treatment. Photographs of the lesion will~     be taken at each study visit. Subjects in the intervention group will then undergo the study~     procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to~     the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA~     incubation and blue light exposure. At 6 months after the last treatment, subjects in the~     intervention group will return for clinical follow-up and surgical excision of the lesion.~     After excision, the specimen will be sent for processing by pathology and subjects will be~     asked to fill out a satisfaction visual analog scale. All slides will be read by a~     board-certified dermatopathologist. Side effects will also be monitored using the same~     graded scale described previously. Mild adverse events that have been associated with PDT,~     including erythema, skin crusting, superficial blistering, hypopigmentation, and~     hyperpigmentation. These reactions usually occur during or immediately after the PDT~     treatment.~   "
2406|NCT03025711|"~     The overall study objective is to evaluate the effectiveness and safety of Trastuzumab~     emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and~     specifically in patients treated under compassionate use or early access program~   "
2407|NCT03025698|"~     This is a phase II, open label, multi-center, intra-patient dose escalation study to~     characterize the pharmacokinetics after oral administration of eltrombopag in combination~     with immunosuppressive therapy in pediatric patients with previously untreated or~     relapsed/refractory severe aplastic anemia or recurrent aplastic anemia.~      All patients will be treated with eltrombopag for the 26-week Treatment Period, followed by~     a 52-week Follow-Up Period. Patients who have been previously untreated with~     immunosuppressive therapy will be treated according to the standard of care,~     hATG/cyclosporine, in addition to eltrombopag. Patients with relapsed/refractory SAA or~     recurrent AA will be enrolled into one of two treatment options: hATG/cyclosporine plus~     eltrombopag or cyclosporine plus eltrombopag, depending on prior treatment with~     immunosuppressive therapy.~      After initiating treatment with eltrombopag, patients will have their dose assessed and~     modified as tolerated, until the targeted platelet count or maximum dose is achieved.~     Pharmacokinetic assessments will be performed at time points intended to capture steady~     state PK of the starting dose and highest dose achieved.~      Upon completion of the Treatment and Follow-Up Periods, all patients will be offered the~     opportunity to enroll in an additional 3 year Long Term Follow-Up Period.~   "
2408|NCT03025685|"~     Adequate support is required for challenging percutaneous coronary interventions (PCI). The~     Radial Ultra Support (RUS)technique is a new support technique that provides active~     support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right~     ventricle-RV) or aorta.~   "
2409|NCT03025672|"~     Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode~     of transmission and its resistance in the environment.~      Nosocomiality is defined by the apparition of an infection 48 hours after the patient's~     hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted~     directly through the hand or from the contaminated environment (during care or not). By~     implementing prevention and optimal treatment, nosocomial infections are preventable.~      A clostridium difficile infection causes an additional cost of patient care for the~     hospital. This additional cost is principally due to the increase of the length of the stay.~     It varies according to patient risk factors,and also according to the reason of the~     hospitalization and can vary from 300 euros (~317$) to more than 25.000 euros (26.460$).~      By determining the increase in the length of the stay and the additional cost due to a~     clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut~     Catholique de Lille), prevention will be valued and measures against those infections should~     be easier to set up.~      The main objective of this study is to evaluate the additional cost of an infection by~     clostridium difficile.~   "
2410|NCT03025659|"~     This is a single-center, observational study. Investigators aim to characterize the~     metabolism of lactate in children over the first forty-eight hours following cardiac~     surgery. Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for~     concentration of pyruvate. Results will be compared to standard of care laboratory results~     for lactate and other direct and indirect measures of cardiac output.~   "
2411|NCT03025646|"~     Background (brief):~      The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the~     estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism~     Spectrum Disorder (ASD) have reported higher level of depression than mothers of children~     with other developmental disorder and the prevalence of ASD is high in Asian countries. In~     Bangladesh 16% of adults suffer from depression and a recent study conducted in Bangladesh~     has documented a high prevalence of depression among mothers of children with ASD (45%).~     Mothers are the life time care givers of children with ASD, and a high burden of depression~     is likely negatively impact on the ability of the mothers to provide care to children at~     home. Mental health is not addressed in Bangladesh and there is scarcity of qualified~     providers.~      Objectives:~      The investigators propose to pilot the feasibility of a package intervention including~     implementation of mental health care and home based training program for the mothers of~     children with ASD integrated in the regular activities of the special schools that offer ASD~     care in Dhaka city in Bangladesh.~      Methods:~      The study will be conducted in 2 selected special schools over 15 months. In the first~     stage, the investigators will set up the study in two schools and identify various~     stakeholders for qualitative assessment of the barriers of implementing the intervention at~     the institutional level, individual level, family level, provider level, policy maker level~     and at the level of the state. Research staff will identify mothers 18 years of age or older~     who has a child with ASD between 3 and 17 years of age enrolled in the school. Following~     consent, data collector will obtain data and assess current major depressive episode (MDE)~     of the eligible mothers following a standard diagnostic tool (SCID-I). All mothers diagnosed~     as having MDE will be invited to participate in the intervention (intervention mothers) and~     the investigators will assess the performances in children with ASD by applying ASD~     Diagnostic Check-list (ADCL).~      In the second stage, investigators will implement interventions over 4-6 months, including~     (a) implementing mental health care services at the selected schools targeting the~     intervention mothers, and (b) organizing training sessions of the intervention mothers for~     supporting child care at home for enhancing child performances. Every month a psychiatrist~     will visit each school for providing necessary advice and treatment to the intervention~     mothers or suggest referral to hospital care, if necessary.~      One special educator will be deployed at each school who will organize structured training~     sessions for educating the intervention mothers by using BCC materials developed and~     validated by icddr,b in the local setting. The special educators will conduct multiple group~     sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time,~     and follow up intervention mothers at home every month for conducting refresher's training,~     documenting the need of additional training supports, and linking mother with an ASD expert~     for helping mothers taking a decision.~      In stage 3, investigators will conduct post intervention qualitative survey with various~     stakeholders who would be involved with implementing the intervention and participated in~     the baseline qualitative survey. End line assessment will be conducted of current major~     depressive episode (MDE) among all mothers and assess the performance of the children of~     intervention mothers in order to assess the impact of the training at home.~      Outcome measures/variables:~      The primary outcome of the study is to assess the feasibility of institutionalizing the~     combined intervention of mental health care supports and the home based training program of~     the mothers who would be diagnosed as having major current major depressive episode. The~     primary outcome will be assessed by obtaining the perspectives of various stakeholders. The~     following parameters will be assessed for measuring feasibility of the proposed~     intervention.~      Acceptability, Adaptability, Demands, Practicality, Implementation, Integration~      The secondary outcomes will include estimating the impact of the combined interventions on~     the prevalence rate of maternal depression (MDE), individual performances of children, and~     cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers~     of children with ASD become skilled workforces for filling in the gap of the special~     educators in resource poor settings, and extension of these services to more children with~     ASD.~   "
2412|NCT03025633|"~     Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side~     effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged.~     Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The~     technique used requires patients to maintain full bladder and empty bowel because they are~     next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose~     received to healthy organs and tissues as this will reduce side effects. PEARL is commercial~     interactive PC software that shows realistic and functional 3D models of Linac's (machines~     that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient~     treatments including how an individual would be laid on a treatment couch and how the~     machine will move and sound during treatment. Additionally PEARL provides the opportunity to~     look inside the body to view internal anatomy and show where the radiotherapy treatment is~     directed.~      Information prior to treatment in radiotherapy is normally given verbally one to one. The~     investigators believe this information can be more easily understood if PEARL is used in~     conjunction with this verbal exchange. PEARL gives visual and audio representation of the~     treatment experience, and demonstrates the reasons behind required preparations.~      Research aim is to demonstrate patients who receive information using PEARL have greater~     understanding, reduced anxiety and reduced radiation dose. This will be tested using two~     groups of patients receiving radiotherapy to the prostate. Group A - Verbal information,~     Group B - Verbal information and PEARL demonstration. Data collection is via patient~     questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken~     prior to each radiotherapy treatment as standard practice. CBCT's are used to locate the~     treatment area and assess bladder and bowel status and ensure all of these are suitable to~     deliver treatment accurately.~   "
2413|NCT03025620|"~     The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential~     of an adequate intake of alpha-linolenic acid in elderly.~   "
2427|NCT03025438|"~     Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint~     cytology is difficult due not only to its various cytomorphologic features but also clinical~     rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,~     and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not~     always present. In order to find clues for cytological diagnosis of angiosarcoma, we~     collected cases of hepatic angiosarcoma to study their cytological features. And then~     compared these features with those in their histopathological biopsy or resection.~   "
2414|NCT03025607|"~     Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical~     activity, yet its prevalence continues to rise. This trend may be due in part to low rates~     of participation in evidence-based lifestyle change programs such as the Diabetes Prevention~     Program (DPP). New strategies are needed to promote healthy behaviors among individuals at~     risk for T2DM, and mobile health technologies may be an effective and scalable approach to~     achieve this. One promising tool is JOOL Health, a mobile phone-based application that~     leverages principles from Self-Determination Theory to help individuals understand how~     certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue~     their core values and purpose in life. Through personalized messaging and feedback, JOOL~     Health aims to increase autonomous motivation, a form of motivation closely associated with~     the initiation and maintenance of healthy behaviors.~      In this mixed methods pilot randomized controlled trial, we will test whether the JOOL~     Health mobile phone-based application -- used alone and in conjunction with other mobile~     health technologies to track weight and physical activity -- can increase autonomous~     motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who~     previously declined participation in a Diabetes Prevention Program (DPP).~   "
2415|NCT03025594|"~     The aim of this study is to demostrate the eficcacy in pain control management after total~     knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before~     wound closure can achieved better pain control and lower morphin use during hospital stay~     compared to local administration of chirocaine, ketorolac and epinephrine~   "
2416|NCT03025581|"~     Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the~     onset of regular uterine contractions.~      PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to~     80% of cases occurring at term. Approximately 90% of patients' experience PROM enter~     spontaneous labor within 24 hours, but disagreement exists among health care providers on~     the optimal management of women with PROM, particularly the need for and timing of~     inductions.~      Nipple stimulation is a non-medical natural method for induction of labor. Previous studies~     demonstrated its effectiveness for initiating labor within 72 hours in women with favorable~     cervices. The actual mechanism by which such a technique results in cervical ripening is not~     well understood.~      In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with~     term PROM choosing expectant management.~   "
2417|NCT03025568|"~     Evaluation of the retention of upper removable partial denture constructed from two~     different flexible thermoplastic materials.(BRE-FLEX and PEEK).~   "
2418|NCT03025555|"~     Evaluation the patient satisfaction and dimensional stability of upper removable partial~     denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).~   "
2419|NCT03025542|"~     This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to~     investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in~     adult subjects with moderate to severe chronic plaque psoriasis~   "
2420|NCT03025529|"~     The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be~     used to help study brain function in healthy people and in those with neurological diseases~     like essential tremor. This portion of the study is being done to establish the optimal~     methods for stimulating the brain to measure its responses.~   "
2421|NCT03025516|"~     This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy~     of two TB breath-based technologies independently of the manufacturers. Assay error and~     failure rates and device operational characteristics will also be assessed during this~     study. Participants will be enrolled in this study in line with FIND sample banking~     activities. Results from index tests will not be used to make clinical decisions.~     Participation in this study will not alter the standard of care.~   "
2422|NCT03025503|"~     This study will examine the use of nipple stimulation for cervical ripening in women who~     present to the labor and delivery ward after their water has broken but have a~     contraindication to prostaglandins.~   "
2423|NCT03025490|"~     The study sets out to assess whether in the context of nurse administered procedural~     sedation in the electrophysiology suite, the routine use of capnography and Integrated~     Pulmonary Index results in lower incidence of severe adverse respiratory events.~   "
2424|NCT03025477|"~     CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian~     advanced cancer.~   "
2425|NCT03025464|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace~     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA~     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter~     OSA screening tool would allow greater screening of at-risk individuals, especially in~     underserved communities with low socioeconomic status, hopefully encouraging a greater~     proportion of such individuals to seek treatment for their condition. Over the past year,~     this investigative team has engineered a small screening device (Zerify®) for OSA and~     obtained preliminary evidence of its efficacy in a clinical population under a~     NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a~     small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,~     transfer these data to a computer, and detect non-clinical simulated apnea events with a~     specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the~     preliminary psychometric performance data of the screening device in a clinical sample of 52~     patients (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard~     polysomnography. Phase II proposal aims to optimize the engineered hardware and associated~     OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,~     and compare the efficacy of this screening device to the most commonly utilized sleep apnea~     screener, the home sleep apnea test (HSAT).~   "
2426|NCT03025451|"~     Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to~     evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household~     member participated in the class with them.~      Participants had health screens before and after completing the class. The data from the~     health screens that will be utilized for comparison will include: body mass index (BMI),~     blood pressure, and fasting blood sugar and lipid levels.~   "
2452|NCT03025113|"~     The purpose of this study is to evaluate the safety and efficacy of an association with one~     anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent~     isolated in the treatment of osteomuscular pain in adults.~   "
2428|NCT03025425|"~     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea~     in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure.~     Subjects are recruited from the local respiratory ward. The main outcomes are the compliance~     of the subjects with the treatment and alleviation of dyspnea during the treatment period.~   "
2429|NCT03025412|"~     Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite~     this, as many as 44 % of achilles tendinopathy patients do not respond to exercise~     treatment.~      Surgery for midportion achilles tendinopathy has for many years been done as an open~     procedure. New knowledge resulted in a variety of minimally invasive procedures and the~     development of endoscopic surgery.~      In this study, the effect of non-open surgery and conservative treatment (physiotherapy and~     exercises) will be compared.~   "
2430|NCT03025399|"~     This study include 384 Participants with diabetic non-proliferative retinopathy~      Design Method: Randomized, double blind, placebo controlled and multicenter clinical study.~     Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of~     tang wang prescription improve degree of retinal microvascular disease of patients with~     diabetic non-proliferative retinopathy.~   "
2431|NCT03025386|"~     A cochlear implant is a device for the rehabilitation of severe to profound hearing loss.~     Despite the standardization of surgical procedures and rehabilitation, speech discrimination~     performance varied significantly in cochlear implant users and could be improved by early~     individualized cares. However, there is no objective method yet to evaluate phonemes~     discrimination, especially in infants, which account for more than half of the indications~     for implantation. In electroencephalography (EEG), it is possible to highlight the~     discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this~     work, this study propose to use the MMN as an objective vocal audiometry method to evaluate~     the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear~     implant users.~   "
2432|NCT03025373|"~     An observational study will be conducted in the ICU (Intensive care unit) including patients~     with heart surgery (< 5 days) and prolonged ICU stay (> 5 days). Patients will receive 5 min~     Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses~     (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the~     virtual world to patients. An integrated eye tracker will measure oculomotor responses that~     will be synchronized with the physiological data recording. All participants will undergo~     neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of~     life prior to the ICU stay will be enquired from relatives. Main outcome variable is the~     explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive~     functioning.~   "
2433|NCT03025360|"~     Larotrectinib (LOXO-101) expanded access is for patients with cancer with a NTRK1, NTRK2, or~     NTRK3 gene fusion who are ineligible for an ongoing larotrectinib (LOXO-101) clinical trial~     or have other considerations that prevent access to larotrectinib (LOXO-101) through an~     existing clinical trial. Expanded access is intended to treat individual patients with~     different types of cancers with a NTRK gene fusion.~   "
2434|NCT03025347|"~     Using a database of individuals with FTO genetic data, the study aims to assess the~     appetite, energy intake and gut hormone responses to a bout of moderate- to high intensity~     exercise in individuals with genetic variations in the FTO gene.~   "
2435|NCT03025334|"~     Parkinson's disease (PD) has been classically regarded as a movement disorder, so earlier~     work has focused on treating motor symptoms only. As PD patients now have longer life~     expectancy, the relatively slowly progressing cognitive deficits (compared to their motor~     deficits) have become one of the major challenges. Approximately 80% of PD patients~     eventually become demented. Therefore cognitive dysfunction is one of the most significant~     factors affecting the quality of life of patients with PD. While dementia in Parkinson's~     disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and~     rivastigmine), their efficacy on mild cognitive impairment found in non-demented PD is~     questionable. Alternative approaches have been proposed including transcranial direct~     current stimulation (tDCS) but no consensus has been reached. This can be attributed mainly~     to: (1) imprecise knowledge of the underlying functional circuitry mediating this disease~     manifestation and (2) inter-individual variability. Here, the investigators will utilize a~     novel personalized network analysis approach to elucidate on the underlying mechanisms of~     the effect of tDCS on cognitive dysfunction in non-demented PD patients.~      It has been well documented that the caudate nucleus plays an important role in cognitive~     dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic~     resonance imaging (fMRI) study, they have shown that the connectivity of the left caudate~     nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive~     Assessment (MoCA). The investigators hypothesize that tDCS on the left dorsolateral~     prefrontal cortex may restore the functional connectivity of the left caudate nucleus which~     may in turn improve patients' cognitive performance.~   "
2436|NCT03025321|"~     Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation~     (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and relapse~     risk. However, little is known about the relapse rates in cocaine addiction after tDCS,~     despite the need for new treatment interventions to reduce the high relapse rates in cocaine~     addiction. The investigators aim to explore the effects of repetitive tDCS in a larger~     sample (N=80) of cocaine addicted patients on number of relapse days after three months. In~     addition, the underlying working mechanism will be explored (e.g. cognitive control~     functioning). Ecological momentary assessment (EMA) will be used to measure relapse, craving~     and mood since retrospective self-reports seem to be less reliable in this respect.~   "
2437|NCT03025308|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     filgotinib in participants who have completed one of the parent studies of filgotinib in~     rheumatoid arthritis (RA).~   "
2438|NCT03025295|"~     The current study is designed to investigate the difference of plasma orexin A levels~     between Dexmedetomidine group and controlled group at emergence time from total intravenous~     anesthesia who will undergo elective lumbar surgery.~   "
3233|NCT03014895|"~     The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,~     single intravenous ascending dose study conducted in Japanese healthy adult males to~     evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single~     intravenous dose of E3112.~   "
2439|NCT03025282|"~     This is an exploratory, single-centre, investigator blinded, randomized, controlled,~     intra-individual study, involving subjects with psoriasis vulgaris.~      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the~     safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once~     daily application.~   "
2440|NCT03025269|"~     This is a Phase IV, prospective, open-label, single-center, observational, longitudinal,~     single blinded study. The investigators will examine the effects of Ocrelizumab on~     cognitive, patient reported outcomes (PROs), quality of life (QoL), multiple sclerosis~     functional composite (MSFC), working status and magnetic resonance imaging (MRI) outcomes~     across 12 and 24 months.~   "
2441|NCT03025256|"~     This clinical research study consists of 2 phases: dose escalation (Phase 1) and dose~     expansion (Phase 2).~      The goal of Phase 1 of this research study is to find the highest tolerable dose level of~     nivolumab that can be given both by intravenous (IV) infusion and intrathecal (IT) injection~     to patients with leptomeningeal disease (LMD). IV infusions are given by vein, while IT~     injections are given directly into the cerebrospinal fluid (CSF).~      The goal of Phase 2 of this research study is to learn if the highest tolerable dose level~     combination found during Phase 1 can help to control the disease.~      The safety of the drug combination will also be studied in both phases.~   "
2442|NCT03025243|"~     The purpose of this study is to evaluate the effect of printing layer thickness on accuracy~     of computer aided surgical guide~   "
2443|NCT03025230|"~     Hypothesis The application of intramuscular electrostimulation will be more effectiveness~     than the dry needling in myofascial trigger points treatment.~      Objetives:~      To determine the effectiveness of intramuscular electrostimulation in the treatment of~     trigger points of the levator scapula muscle for the improvement of pain in mechanical~     cervicalgia.~      Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and~     active trigger points in levator scapulae muscle, randomly assigned to experimental or~     control group.~      Intervention: Control group: one session of dry needling in active trigger points;~     experimental group: one session of intramuscular stimulation in active trigger points.~      Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion~     and strength muscle . The measures will be taken before, after and one week after the~     interventions.~   "
2444|NCT03025217|"~     The investigators aim to develop, pilot and evaluate a new Total Lifestyle Coaching (TLC)~     program, that will address both information and behavior-change aspects of nutrition~     education for patients whose body mass index (BMI) exceeds 25.~   "
2445|NCT03025204|"~     Approaches and objectives related to the treatment of patients with aggressive periodontitis~     are not markedly different compared patients with the chronic form. However, the large bone~     loss related to young age in this aggressive form, justify a well-founded strategy,~     intending to further stabilization of disease progression. For this, should make use of~     regenerative therapies in the advanced stages of treatment. Noteworthy is the use of~     proteins derived from the enamel matrix (EMD) in patients with chronic periodontitis, but~     there is little evidence about the effects of this material in aggressive periodontitis.~     Thus, the present study aims to evaluate the use of EMD in patients with aggressive~     periodontitis, comparing them to individuals with chronic periodontitis. Will then be~     selected 45 subjects, among patients with generalized chronic periodontitis (GCP) and~     generalized aggressive periodontitis (GAP), with one or more intra-bony defects in~     radiographic examination, with a minimum size of 4 mm deep and 2 mm horizontal, associated~     with a probing depth (PD) ≥6mm, to be treated according to the groups: GAP+OFD (n = 15) GAP~     patients which will receive open flap debridement; GAP+OFD/EMD (n=15) GAP patients which~     will receive open flap debridement and application of EMD; GCP+OFD/EMD (n=15) GCP patients~     which will receive open flap debridement and application of EMD. Clinical evaluations will~     be performed at baseline, 3, 6 months and 1 year after. At baseline, 7, 15, 45 days, 3, 6~     months and 1 year after will be collect samples of gingival fluid to detect bone markers by~     Luminex / MAGpix technology. For the periods baseline, 3, 6 months and 1 year will be~     collected subgingival biofilm for the detection and quantification of periodontal pathogens~     by real-PCR. Will still be carried x-rays on baseline, 6 months and 1 year after, and~     questionnaires about patient satisfaction and perception of therapy at baseline, 7 days and~     6 months. To compare the parameters evaluated, ANOVA, Tukey, chi-square, Spearman and Person~     tests will be used (α = 5%).~   "
2446|NCT03025191|"~     The purpose of this study is to adapt an existing couples-level HIV prevention intervention~     for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among~     couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and~     acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and~     their community-dwelling committed female partners.~   "
2447|NCT03025178|"~     We previously performed a study to create formula for the optimal insertion depth of left~     internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found~     that two calculation methods using height and the distance between landmarks (0.11 × height~     (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the~     most prominent point of the sternal head of the left clavicle, and B was the midpoint of the~     perpendicular line drawn between the sternal head of the right clavicle and an imaginary~     line between the nipples) were clinically feasible to determine the insertion depth of left~     internal jugular vein catheter. In this study, we will compare the actual insertion depth~     with the insertion depth determined from above two calculation methods in other 46 infants.~   "
2448|NCT03025165|"~     The purpose of this study is to compare the virological and clinical outcomes of patients~     participating in community models of ART delivery to the standard of care in an urban~     setting in Zambia.~   "
2449|NCT03025152|"~     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving~     symptoms and indicators in patients with spleen qi deficiency and radical gastrectomy for~     gastric cancer.~   "
2450|NCT03025139|"~     This randomized phase III trial studies how well mindfulness meditation or survivorship~     education work in improving behavioral symptoms in younger stage 0-III breast cancer~     survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help~     patients change the way they react to environmental triggers that may cause a negative~     reaction. Survivorship education after treatment may reduce stress and improve the~     well-being and quality of life of patients with breast cancer. Mindfulness meditation or~     survivorship education may help improve the health behaviors of younger breast cancer~     survivors.~   "
2451|NCT03025126|"~     Congenital or acquired neurological disorders could lead to consistent motor and cognitive~     disabilities. The continuity and persistency of a tailored home rehabilitation protocol~     after recovery is crucial to prevent disease aggravation or relapses. The integration of a~     web-based new technology in home rehabilitation programme can constitute a functional low~     cost resource by offering patients off-line (and on-line) monitoring and by proposing new~     motivating ways of rehabilitation through high tech tools such as serious games.~   "
2453|NCT03025100|"~     Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes~     mobility evaluation. Mobility is a key component of risk stratification. Poor mobility~     evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis.~     The investigators aim is to propose to determine whether level of mobility during~     hospitalization is being used to influence use and duration of VTE prophylaxis among~     medically ill hospitalized elders. To achieve this aim, the investigator will collect~     prospective observational data to objectively measure inpatient mobility using patient~     mounted accelerometers during patient hospital stays.~      The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among~     those in which the risks of harm may outweigh the benefit. Results from this study will~     provide important insights about use of risk assessment, and the relationship between~     patient mobility and VTE prophylaxis. These results are critical to understanding how to~     take the next steps toward improving the appropriate use and safety of anticoagulants in~     hospitalized older adults. Information from this study could be used in future proposals to~     study interventions to ultimately improve hospital practice in the care of older adults.~   "
2454|NCT03025087|"~     The purpose of this study is to determine whether hydroxychloroquine decreases the relative~     leakage of the brain barrier after surgery.~   "
2455|NCT03025074|"~     The purpose of establishing a biorepository is to provide high quality specimens (serum,~     plasma, buffy coat and liver tissue) for future researchers who are studying the effects~     that fatty liver and viral diseases have on the liver.~   "
2456|NCT03025061|"~     Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in~     Children With Moderate or Severe Asthma is an observational prospective study in outpatient~     clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and~     Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR),~     Italy.~      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the~     level of airway inflammation for different respiratory diseases, especially in children. To~     date, there are no data on the within-day and the between-day repeatability of the breath~     pattern in healthy children and in children with moderate or severe asthma.~      The breath pattern will be analyzed by collecting, for each child, three samples of the~     breath through the E-nose. Within-day repeatability will be assessed using two consecutive~     measurements (the second one after 30 minutes). Between-day repeatability will be assessed~     using a third measurement repeated after 7 days.~      The study is expected to provide information about the accuracy of E-nose measurements for a~     child population.~   "
2457|NCT03025048|"~     People with spinal cord injury are at increased risk for overweight and obesity, type 2~     diabetes, cardiovascular disease and decreased quality of life compared With able bodied.~      This pilot aims to assess the impact of a nutrition intervention that combines several~     methods to help people change their lifestyle.~      The pilot project combines individual interviews and personal lifestyle goals (diet) with~     group classes for people with long-standing spinal cord injury.~      In addition to nutrition theory and practical exercises for diet-planning, motivational~     interviewing and mindfullness are incorporated into the course. The course is~     interdisciplinary, but is led primarily by a dietitian. Data is collected before the course~     starts and right after the 9-week course ends. The measurements involves self-perceived~     quality of life, food diary, weight, waist circumference and body composition (measured by~     BIA and DXA).~   "
2458|NCT03025035|"~     This trial will evaluate the use of immunotherapy in a population with incurable advanced~     breast cancer associated with a germline BRCA mutation. The main objective is to examine~     overall response rate of pembrolizumab (immunotherapy) single agent therapy in advanced~     BRCA-mutated breast cancer.~   "
2459|NCT03025022|"~     The objective of this study is to evaluate the absorption, distribution, metabolism, and~     excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40~     milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability~     will also be assessed.~   "
2460|NCT03025009|"~     The main purpose of this study is to investigate the side effects related to LY3192767 when~     given as an injection under the skin to healthy participants. Blood tests will be done to~     check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to~     get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and~     Part B. Each participant will enroll in one part. For each participant, Part A will last up~     to about 32 days after last dose and Part B will last up to about 49 days after last dose.~     Screening must be completed prior to study start.~   "
2461|NCT03024996|"~     This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to~     evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who~     are at high risk of disease recurrence following nephrectomy.~   "
2462|NCT03024983|"~     Carbohydrate-based products can influence the post-prandial glycemic response differently~     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta~     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature~     describe a lower glycemic response after the consumption of pasta compared with other~     wheat-based products, such as bread. Among the factors affecting post-prandial glycemia~     after consumption of carbohydrate-based products, the technological process represents a~     central one.In fact, the different technological processes alter the food matrix which can~     affect the post-prandial metabolism of glucose differently. Thus, the present study aims at~     investigating the effect induced by the principal steps of the process of pasta production~     on the reduction of post-prandial glycemic response (post-prandial glucose, insulin, GLP-1,~     GIP plasma concentrations).~   "
2463|NCT03024957|"~     this work aims to investigate the effect of intrathecal administration of Morphine,~     Dexmedetomidine or both in combination on cellular immunity and cytokine production in~     patients undergoing major abdominal cancer surgeries.~   "
2504|NCT03024424|"~     The goals of this study are:~      To assess the impact of genetic testing based on how it alters behaviors, to assess the~     utility of serum biomarker measurement in combination with genetic testing, to assess the~     utility of genetic counseling in personal analysis of risk for age-related macular~     degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal~     neovascularization (CNV).~   "
3912|NCT03006003|"~     The study will be conducted to assess the depressive symptoms and related markers in the~     postmenopausal female after anti-osteoporosis treatment.~   "
2464|NCT03024944|"~     The purpose of this project is to study brain imaging of a substance called tau, which is~     found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for~     live imaging of tau in the brain. The main goal of this proposal is to study whether~     diabetes status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with~     normal glucose tolerance [NGT]), is associated with increased tau accumulation in the brain,~     one of the culprits of Alzheimer's disease, in a community-based group of middle aged~     Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau~     positron emission tomography (PET) imaging in 30 middle aged Hispanics.~   "
2465|NCT03024931|"~     Severe burn patients are some of the most challenging critically ill patients with an~     extreme and continuous state of physiological stress. Patients tends to stay for a long~     period of time in intensive care unit to treat burns as well as dealing with complications~     that arises from the initial burns injury. Severe burns patients are notoriously known to~     loose weight. The word 'catabolism' is used medically. This theory of catabolism after a~     trauma was hypothesised in 1942 by Professor Curthberston and based on animal models. Since~     this date, despite medical technological advancement, there has been no research that~     confirms Professor Curthberston's theory. Investigators still do not know the exact~     mechanism by which the body changes from conserving energy to becoming catabolic.~     Furthermore, it remains unclear whether this change in catabolism is necessary to heal from~     burns injury.~      This theoretical catabolism in burns patients is currently treated with nutritional~     supplement, use of medications including beta-blockers (suppresses heart rate and decreases~     blood pressure) and oxandrolone (formula which is similar to testosterone to build up~     muscles).~      There are evidences to suggest that increase in weight loss worsens the outcome in burns~     injury. Both overfeeding or underfeeding patients can be detrimental. In this research, the~     exact changes in metabolic rate will be measured in the first 72 hours of the study using a~     calorimetry machine. In addition to the metabolic rate, the response to the heart, liver,~     kidneys and hormonal levels will be measured. By looking into these dynamic changes the~     investigator will be able to elucidate whether there is a real increase in metabolic rate.~     If there is, the investigator would also be able to tell the response of different organs~     and whether there are any hormones that could be responsible to inflicting the metabolic~     changes.~   "
2466|NCT03024918|"~     This is an observational study in 3 cohorts of monochorionic diamniotic (MCDA) twins. The~     aim of the study is to assess whether unequal placental sharing can be predicted in~     pregnancy and whether it is predictive of pregnancy outcome.~   "
2467|NCT03024905|"~     The purpose of this trial is to establish if several interventions will help women in rural~     Tanzania access health care services during pregnancy and at the time of delivery. The~     interventions include education about the importance of attending antenatal care visits with~     nurses and facility deliveries, a voucher for transport to access the health facility at the~     time of delivery, and supplies to be used either at the health facility, or on route if the~     women does not make it to the health facility.~   "
2468|NCT03024892|"~     The investigators will collect the pre-operative medical history and arrange physical~     examination, life quality evaluation, blood and biochemical test. The Patients with acute~     cholecytitis, gallstone or gallbladder polyp without interventional treatment or~     cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.~     Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established.~     In study group , ICG was give by intra-gallbladder injection or systemic injection, the~     cholecystectomy were performed . In control group, no ICG was given and traditional~     cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the~     ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before~     cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was~     started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded.~     Conversion rate, post-operative morbidity and mortality will be recorded as well .~   "
2469|NCT03024879|"~     In this study, the investigators aimed at evaluating the role of motilin in the regulation~     of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy~     volunteers and is significantly increased in obese patients. Its role in food intake~     regulation might contribute to the pathogenesis of obesity.~   "
2470|NCT03024866|"~     This is a retrospective-prospective study design. Patients who completed treatment~     approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be~     identified and any existing data in the patient's record will be collected in addition to~     conducting office visits for long-term follow-up.~   "
2471|NCT03024853|"~     The aim of this study is to analyze the efficacy of several variations of an already~     validated Positive Psychology Intervention (PPI) called Best Possible Self, using~     Information and Communication Technologies (ICT) in general population. Participants are~     randomly assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS~     FUTURE condition, and CONTROL condition (daily activities).~   "
2472|NCT03024840|"~     To study the effect of different anaesthetic methods on pediatric neurocognitive development~     and cerebral injury during pediatric living related liver transplantation .~   "
2473|NCT03024827|"~     This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal~     Extract in a small group of children with refractory epileptic encephalopathy. The dosage of~     Cannabis Herbal Extract will be gradually increased over a four month time period.~   "
2474|NCT03024814|"~     The purpose of this study is to determine whether acetaminophen is effective in prevention~     or reducing the severity of IVH in premature infants.~   "
2475|NCT03024801|"~     To analyze the effectiveness of intra-articular injection of autologous PRP on knee~     cartilage repair and evaluating functional recovery of the knee joint in knee cartilage~     injury patients.~   "
2476|NCT03024788|"~     Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence:~     determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China~   "
2505|NCT03024411|"~     Data are lacking regarding the use of music and video games for the management of pain in~     labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks~     will be approached for participation in the study. Patients will be randomized to a~     music/video games group and a non-music/video games group. Those randomized to group with~     music/video games will be given an iPod for those purposes.The primary outcome will be the~     time for patients to request pain medications after Foley bulb placement. The two groups~     will be compared for differences in pain outcomes.~   "
2527|NCT03024125|"~     This study evaluates the effect of different types of diets (high and normal protein) on~     lean and fat mass, and strength in postmenopausal women practitioners of resistance~     exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal~     protein (0.8 protein g/body mass/day). The same training will be performed for both groups.~   "
2477|NCT03024775|"~     Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal~     symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat~     allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.~     Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine~     inhibitors, ATIs) can cause the symptoms, and therefore the term non-celiac wheat~     sensitivity (NCWS) has been proposed instead of NCGS. It is believed that this condition is~     worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats~     with high gluten content), and that ancient wheats are better tolerated by NCWS patients~     than the modern ones. Therefore, the aim of the study is to determine whether the common~     belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the~     modern ones is confirmed by scientific data, and to identify the wheat kernel components~     triggering this pathology. The availability of wheat materials with opposite~     characteristics, such as the period of development (ancient vs. modern), or the~     technological properties (cultivars with weak glutens vs. strong gluten), or the~     presence/absence of specific ATIs polypeptides, will allow to define the role played by~     these factors. Therefore, the study has two objectives: 1) extraction and testing of total~     kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten~     proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the~     rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two~     wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest~     and the lowest in vitro inflammatory response, in order to verify their effect in triggering~     NCWS symptoms.~   "
2478|NCT03024762|"~     The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability,~     feasibility and effectiveness of the targeted provider-initiated-testing and counseling~     (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC)~     among children and adolescents in Cameroon. The new knowledge generated will inform~     programming of more suitable strategies to identify HIV-infected children and adolescents~     and this will contribute to reducing the current global gap in HIV treatment among this~     subpopulation group.~   "
2479|NCT03024749|"~     Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex~     neurosurgical lesions that are very challenging to manage. Spinal vascular malformations~     account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our~     understanding of these lesions has dramatically increased thanks to neuroimaging technology~     (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities~     including conservative observation, endovascular embolization, microsurgical resection,~     radiation therapy, and combined therapies have been reported. The treatment for these AVMs~     and AVFs depends on their location, the type of malformation, the area of the spine~     involved, and the condition of the patient at the time of treatment. Due to the rarity of~     these spinal vascular lesions, reports of their management and outcomes have been limited to~     small series and case reports. And the rates of obliteration and outcomes are not~     satisfactory, especially the spinal AVMs. Spinal vascular lesions are rare but represent a~     formidable challenge for the treating neurosurgeon.The purpose of this study is to establish~     multimodality treatment mode and evaluate the anatomical cure rate and functional~     preservation rate.~   "
2480|NCT03024736|"~     In this retrospective chart review, the investigators plan to analyze the effects of~     buprenorphine compared to methadone in opioid-maintained pregnant women. The investigators~     will evaluate both maternal and neonatal outcomes, with a primary outcome of infant hospital~     length of stay. The investigators will evaluate patients receiving care in a single setting.~   "
2481|NCT03024723|"~     The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities~     with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal~     continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway~     patent with near 100% success in patients with OSA. Obesity is a major risk factors for~     obstructive sleep apnea and obese patients have a higher prevalence of UAO during~     anesthesia. The investigators hypotheses that nCPAP should eliminate airway obstruction in~     obese patients under anesthesia. The investigators propose to test this hypothesis and~     determine the efficacy of nCPAP on maintaining airway patency in obese patients who require~     general anesthesia compared with CPAP administering face mask.~   "
2482|NCT03024710|"~     Infant feeding practices and nutritional status among children is interrelated and link is~     well established. Incidence of malnutrition sharply rises during 6-9 months of age in most~     of the developing countries which coincide with the period of complimentary feeding (CF).~     This prospective randomized trial will be implemented in ongoing health and demographic~     surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child~     health services area. Area of community health workers (four blocks) will be divided into~     two pairs and each pair will be randomly assigned into intervention or control groups. The~     eligible and consented mother-infant newborn will be recruited either into an intervention~     or control groups based on the areas of the paired block. The mothers and family members of~     the intervention area will receive intensive counseling on complementary feeding practices~     through community health workers. In total about 360 mother-infant pair will be recruited in~     the study for each site. Data on children's anthropometry (weight and lengths), information~     on complementary feeding practices and related covariates will be collected through trained~     research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting,~     underweight, wasting) and complimentary feeding index between intervention and control~     groups.~   "
2483|NCT03024697|"~     In this proposed study, the investigators are looking to conduct a prospective, randomised,~     double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks~     versus continuous local anaesthetic infusion analgesia versus a combination of PECs blocks~     and local anaesthetic infusion analgesia, when it comes to providing analgesia for most~     forms of breast surgery.~      Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques~     involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are~     growing in popularity, as they reduce the amount of opioid medications used. Opioids are~     associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as~     such, opioid-sparing analgesic regimens postoperatively are becoming more common. These~     regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug),~     and a local anaesthetic technique.~      Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations~     within the chest wall, typically done after the patient undergoes general anaesthesia, but~     before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion~     of a catheter into the wound at the end of surgery, before the patient emerges from general~     anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each~     technique is considered extremely safe, and is considered acceptable as a form of pain~     relief in patients undergoing breast surgery.~      There are no published works comparing pectoral plane blocks with local anaesthetic infusion~     pump analgesia, and the investigators see a gap in the knowledge base that can be addressed.~     This study will allow efficacy, safety and cost of the three techniques to be compared. The~     investigators feel the study design is robust, and statistical analysis based on previously~     published works in the area of postoperative analgesia has allowed the study to be powered~     appropriately.~      Patients undergoing breast surgery are a vulnerable group, and this is recognised via the~     provision of a comprehensive Patient Information Leaflet and a commitment to respecting the~     process of Informed Consent. The investigators also recognise this is a stressful period in~     a woman's life, and the study will be conducted in a sensitive and compassionate manner.~      The study has been designed to be prospective, randomised, and double-blinded. The~     anaesthetic will be standardised in relation to analgesic and anti-emetic agents~     administered, in order to minimise variables. Chronic post-surgical pain is a growing area~     of research, and the follow-up telephone interview at 3-months will allow investigation of~     this.~      A Data Record Form will be utilised for data collection, which will subsequently be analysed~     statistically. Data will be handled sensitively, securely, and by the minimum number of~     researchers. A plan is in place for destruction of data at an appropriate time.~      While there will be no direct benefit to participants, including monetary considerations,~     this research study will add to the knowledge-base surrounding analgesia for breast surgery.~   "
2484|NCT03024684|"~     The purpose of this study is to evaluate whether statin could prevent recurrence of~     hepatocellular carcinoma after curative treatment~   "
2485|NCT03024671|"~     The dermatological testing of cosmetic products which are new on the market, or existing~     products with novel formulations is common and a useful procedure, yet necessary to~     alleviate common irritants and contact allergic reactions. Cosmetic products contain a range~     of substances that may be considered as potential irritants or contact allergens. In order~     to estimate that risk, cosmetics are tested by applying patch tests.~   "
2515|NCT03024281|"~     Primary objectives:~        1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates~          collected in participating hospitals in Taiwan~        2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates~          in Taiwan~        3. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in~          Taiwan~        4. To investigate the clonality of Aspergillus clinical and environmental isolates in~          Taiwan~        5. To describe the genetic relationships between local resistant strains with global~          strains~      Secondary objective:~        1. To describe the clinical characteristics and treatment outcome of patients with proven~          or probable invasive aspergillosis~        2. To evaluate the clinical impact of azole resistance in patients with proven or probable~          invasive aspergillosis in a case-control study~   "
2486|NCT03024658|"~     Background: Positive end expiratory pressure (PEEP) at the time of induction increases~     oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all~     cases. Factors affecting the action of PEEP have not been elucidated well and remain~     controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been~     proven in previous studies. Thus this study was planned to evaluate the action of PEEP on~     the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily~     measured by trans-thoracic echocardiography.~      Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA~     grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic~     bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated~     in the study. Thirty patients received no PEEP at the time of induction while other 30~     patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at~     the time of intubation, 5 min after intubation and 10 min after intubation. Patients were~     then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP~     or > 30 mm Hg~   "
2487|NCT03024645|"~     The main goal of the research is to apply and evaluate the web-based preventive intervention~     (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's~     adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial~     (RCT), the investigators will conduct a pilot trial to evaluate the preliminary version of~     the Be a Mom program in high-risk women (random assignment to the intervention or to the~     control condition).~      The RCT will be a three-arm prevention trial. Women who have had a child during the prior~     month will be enrolled in the study. A minimum number of 1000 women will be enrolled in the~     study. After agreeing to participate in the study, the women will be screened for the~     presence of risk factors for PPD and early-onset PPD symptoms (using self-report~     questionnaires) by a researcher (licensed psychologist). In case of a negative screen,~     women's participation in the study will end. In case of a positive screen (high-risk women),~     women will be randomly assigned to one of the conditions: the Be a Mom program, the Be a Mom~     program with partner (the partner will be invited to assist the program with the woman), or~     the control condition. The sample will be recruited at the maternities of Coimbra University~     Hospitals-CHUC, EPE.~      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.~     Participants in both conditions will be invited by the researchers via email to complete~     baseline, post-intervention and follow-up (4-months and 12-months after childbirth)~     assessments. Assessments will include self-report questionnaires to assess several~     indicators (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding,~     and maternal confidence), mechanisms that may be involved in the treatment response (e.g.,~     negative automatic thoughts, psychological flexibility, emotional regulation) and user's~     acceptability and satisfaction.~   "
2488|NCT03024632|"~     This is a retrospective chart review. The purpose is to look at the outcomes for women and~     newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.~   "
2489|NCT03024619|"~     This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis~     (IC) pain, with emphasis placed on exploring the type and severity of pain.~   "
2490|NCT03024606|"~     The investigators propose an 18-month, randomized, open-label evaluation of the impact of~     texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients~     will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years~     of age, are in the preparation stage of change and willing to set a quit date within 30 days~     and before 35 weeks gestation, and have a cellular phone that is capable of receiving text~     messages. Patients will be randomized to either the texting group or control group. A~     baseline carbon monoxide level will be obtained. The patient, regardless of group, will have~     the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem~     that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy~     patches or bupropion free of charge in 2-week intervals. Patients in the intervention group~     will receive text messages focused on smoking cessation and pregnancy. Patients will be seen~     on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet~     with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be~     continued until the pharmacotherapy course is complete.~   "
2491|NCT03024593|"~     The purpose of the current study is to examine the effects of health-related internet use on~     affect, health anxiety and symptom severity in individuals with pathological levels of~     health anxiety. The present randomized controlled study compares an online medical searching~     condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus.~     After an induction of health anxiety using the Autobiographical Emotional Memory Task the~     participants in the searching condition go online and search for subjectively relevant~     health information (external focus of attention). Individuals in the waiting (i.e.~     non-searching) condition are requested to do nothing and not to distract themselves~     (internal focus of attention).~   "
2492|NCT03024580|"~     This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors~     in advanced breast cancer.~   "
2493|NCT03024567|"~     To perform a randomized, double-blind clinical study on the effects of an increased salt~     intake on metabolic, cardiovascular and immunological parameters and the gut microbiota~   "
2494|NCT03024554|"~     To determine the safety and efficacy of the BMFM® kit in the use for the endovascular~     treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of~     the aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic~     MFM® has CE mark approval for the aortic aneurysm treatment.~   "
2495|NCT03024541|"~     Anticholinergic and sedative drugs are frequently prescribed to older people, despite their~     negative impact on older people's physical and cognitive function. To estimate the~     cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug~     Burden Index (DBI) in 2007. The present study aims to complement previous study findings~     showing higher DBI values to be associated with physical and cognitive impairment. Most~     previously conducted studies of the DBI were either cross-sectional or were longitudinal but~     with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra~     risks for patients with dementia. Finally, relatively little is known about the stability of~     DBI values over time. The current project therefore aims to examine (1) longitudinal~     relationships between long-term cumulative exposure to anticholinergic and sedative drugs as~     measured with the DBI and cognitive and physical function, (2) to examine interaction~     effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure,~     i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These~     project aims will be studied with longitudinal data from eligible participants > 60 years~     from the LASA study with participants being followed-up during two decades, and the~     longitudinal data from the InterRAI consortium. Various clinical outcomes regarding~     cognitive and physical function will be studied. Data will be analysed with generalised~     linear mixed models and Latent Class Growth Analysis.~   "
2496|NCT03024528|"~     Pain experienced by critically ill patients is a major problem affecting nearly 50% of the~     patients. Assessing pain in critically ill patients is a challenge even in an intensive care~     unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to~     self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation~     Tool.~      Aim: The aim of this study was to validate the Polish version of a behavioural pain~     assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus~     self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious~     patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).~      Method: A prospective observational cohort study will include 70 patients. The patients will~     be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure~     (turning). Patients will be observed 5 minutes before, during, and 15 min after the two~     interventions (six assessments). Each CPOT assessment will be carried out by two observers~     blinded to each other. To validate the Polish CPOT translation calculations of interrater~     reliability, criterion validity and discriminant validity will be performed.~   "
2497|NCT03024515|"~     Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild~     pain can usually be controlled with simple analgesics, more severe pain may require~     initiation of opioid analgesics. The World Health Organization (WHO) has developed a~     specific guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who~     have severe pain despite non-opioid and weak opioid analgesics are advised to step up to~     level 3 - Strong Opioids. Morphine is the most common opioid strong analgesic prescribed~     in Hong Kong. To the best of our knowledge, there is no formal opioid pain control guideline~     developed for cancer patients in Hong Kong. The prescription practices of various physicians~     who treat advance cancer patients, including oncologists and palliative care physicians have~     never been audited or standardized.~      Furthermore, there are inherent issues with the administration of oral morphine. Currently,~     only one fixed concentration is available in a liquid formulation. Patients are known to~     have difficulties in receiving the appropriate dose. Accurate measurement of the volume~     required is extremely difficult, and many a times patients will report to have spilled the~     oral morphine during decanting, or will report that they have not been taking adequate doses~     because they are worried that they will decant too much into a spoon or syringe and overdose~     themselves.~      Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to~     Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release~     (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include~     ease of administration; different groups have previously reported less adverse effects and~     better treatment compliance. However, to date, there has been no prospective 'head-to-head'~     comparison have ever been carried out comparing this with the traditional, well-accepted~     methods.~      The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR~     may be superior to traditional medication choices and schedules in terms of time required~     for onset of pain control, the side effect profile, patients' tolerability and compliance to~     treatment. Interestingly, through this randomized open-label prospective study, we also aim~     to capture information on current opioid prescription practices by clinicians who manage~     patients with advanced cancers, which will be useful for us to consider the establishment of~     territory-wide treatment guidelines at a later juncture.~   "
2498|NCT03024502|"~     The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis~     standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies~     with both propolis gels will be performed in comparison with clotrimazole cream in patients~     presenting vulvovaginal candidiasis.~   "
2499|NCT03024489|"~     Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle.~     Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many~     cancers. Several mechanisms have been described: (i) Amplification or overexpression of~     cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of~     the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous~     cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the~     CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53~     functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need.~      Palbococlib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with~     ability to block Rb phosphorylation in the low nanomolar range. The most advanced~     development is in a treatment of metastatic breast cancer. In addition, palbociclib showed a~     radiosensitization property. Since combination of cetuximab and radiation improved PFS and~     overall survival (OS) in locally advanced unresectable SCCHN when compared with radiation~     alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab,~     and radiation for locally advanced unresectable SCCHN. Because many genetic alterations in~     SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of~     palbociclib in this combination will be explored.~      Thus, the investogators propose a non-randomized, dose escalation, phase I study designed to~     determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT~     for locally advanced unresectable SCCHN.~   "
2500|NCT03024476|"~     BOSS-Trial I is a phase 2 clinical trial with the following objectives;~        1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world~          clinical practice and wireless connection to the main server;~        2. to prove the feasibility of the BP management strategy, including the pre-specified BP~          range, BP management algorithm, and behavioral; and~        3. to gather information for the phase 3 trial including BP variability indices and their~          potentials as a treatment guidance.~   "
2501|NCT03024463|"~     In addition to axillary lymph node (ALN), internal mammary lymph node (IMLN) chain is also~     the first-echelon nodal drainage site for metastasis and it provides important prognostic~     information in breast cancer patients. However, decision about local treatment of IMLN is~     still being made based on ALN status. The 2016 National Comprehensive Cancer Network~     Guidelines recommend internal mammary lymph node irradiation for patients with more than 4~     positive ALNs (category 1), and strongly consider irradiation for patients with 1 to 3~     positive ALNs (category 2A). Therefore, there will be patients in positive ALN subgroup who~     just face complications of an unnecessary radiation to IMLN and there will be patients in~     negative ALN subgroup who do not receive adjuvant radiation therapy they really need. Thus,~     these inclusion criteria of National Comprehensive Cancer Network might lead to~     over-treatment and under-treatment. Internal mammary sentinel lymph node biopsy (IM-SLNB)~     provides a less invasive method of assessing the IMLN than surgical dissection. However, low~     visualization rate of IM-SLN has been a restriction of IM-SLNB. A modified radiotracer~     injection technique was established in our previous study. This technique could~     significantly improve the IM-SLN detection rate. The investigators have validated the~     accurate of the hypothesis and the modified radiotracer injection technique in the previous~     study.~      Recently, the investigators propose that if IM-SLN is the only metastatic lymph node and~     there would be no positive node else in IMLN chain, the radiotherapy and its associated~     complications could be avoided in these patients. On the other hand, if there is the~     presence of metastatic non-sentinel lymph node (NSLN) in IMLN chain after IM-SLNB, it is~     important to predict the risk of IM-NSLN metastasis in IM-SLN positive patients. As there is~     currently no such model, a predictive model for IM-SLN positive patients to avoid~     radiotherapy is needed in this situation. Therefore, a new study will be conducted to verify~     the issues above.~      In the current study, all the participants (18~70 years of age) would have the preoperative~     pathology of invasive breast cancer and positive fine-needle aspiration result in their~     clinical or ultrasonic suspicious axillary lymph node. 99mTc-labeled sulfur colloid was~     injected into the parenchyma under the ultrasound guidance 3 to 18 hours before surgery. Two~     syringes of 9.25 to 18.5MBq 99mTc-labeled sulfur colloid in 0.5 to 0.7mL volume were~     injected at the 6 and 12 o'clock positions 0.5 to 1.0 cm from areola (about 2.0~4.0 cm from~     the nipple). IM-SLNB was performed in all participants with IMSLN visualized on preoperative~     lymphoscintigraphy and/or detected by the intra-operative gamma probe. All hotspots in the~     internal mammary basin were harvested and intra-operative identification of the IM-SLN was~     based on gamma probe detection. The IM-SLN was sectioned along the long axis into two blocks~     and all blocks were tested by the frozen section and the touch imprint cytology~     intra-operatively. Those participants with positive intra-operative results received IMLN~     dissection. Finally, all the IM-SLN blocks and IM-NSLN dissected were assessed~     post-operatively by H&E and Cytokeratin 19 stained immunohistochemistry. The conclusion~     would be drawn through the results mentioned above.~   "
2502|NCT03024450|"~     Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric~     cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with~     clinicopathologic factors remain unclear. The object of the study is to determine whether~     the addition of trastuzumab to first-line chemotherapy improves efficacy compared with~     chemotherapy alone in HER2 positive AGC.~   "
2503|NCT03024437|"~     This study will assess the immunomodulatory activity of entinostat in patients with advanced~     renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is~     that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1~     inhibition by suppressing Treg function. We have chosen renal cell carcinoma that has been~     reported to respond to PD1/PD-L 1 inhibition. The schedule of entinostat is based on our~     previous experience with this agent. Based on our working hypothesis that low dose HDAC~     inhibitors will have a suppressive function on Tregs but not on T effector cells, the~     starting dose of entinostat will be 1 mg and will be escalated up to 5 mg rather than the 10~     mg dose. The combination also with bevacizumab will provide an effective VEGF inhibition~     that may potentiate the immune response and anti-tumor effect induced by atezolizumab. The~     proposed dose and schedule for atezolizumab and bevacizumab has been shown to be well~     tolerated in prior Phase/I/II studies and is currently tested in a Phase III randomized~     study in patients with renal cell carcinoma with sunitinib as a control arm. The highest~     proposed dose level for entinostat (5 mg) represents 50% of the recommended Phase II dose~     for this compound as a single agent.~   "
2506|NCT03024398|"~     Selective lymphadenectomy Sentinel (LSS). This technique is already well established in~     breast cancer and melanoma and more recently in vulvar and cervical cancer.~      Compared to lymphadenectomy, it has several theoretical advantages:~        -  this is a sensitive technique with a detection rate of> 90% and a false negative rate~          of <5%.~        -  the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin~          antibodies, serial sections) are more sensitive than the standard histological analysis~          of lymphadenectomy, which allows an improvement in the detection of metastases~          (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to~          detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in~          15% of intermediate-risk patients.~        -  it avoids short-term and long-term operative and post-operative morbidity of~          lymphadenectomy.~      Early studies of LSS in endometrial cancer demonstrated superior efficacy of the~     colorimetric method coupled with the Technetium 99m isotopic method with an overall~     detection rate of 78% [95% CI: 73-84]. The fluorescent green of indocyanine appears to give~     better results with an overall detection rate of 94% and a bilateral detection rate of 80%.~      It seemed useful to take stock of this technique using this new dye.~   "
2507|NCT03024385|"~     This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low~     Birth Weight Infant through Continuous Quality Improvement Techniques) Network~     (collaboration of academic family medicine providers). The project involves assessing~     maternal risk behaviors that significantly affect subsequent birth outcomes: specifically~     smoking cessation, maternal depression, family planning and preconception folic acid~     supplementation during well child (WCC) visits. There is evidence that screening mothers for~     depression can be done at WCC. Data from IMPLCIT network has demonstrated increased~     screening and referral rates as well as decreased rates of prematurity. This is the first~     collaborative effort between Pediatrics and Family Medicine.~   "
2508|NCT03024372|"~     The purpose of this study is to investigate a promising strategy to improve maturation and~     patency rates following creation of AV fistulas and assess whether an anastomosis performed~     with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or~     patency than one performed with conventional suturing techniques.~   "
2509|NCT03024359|"~     Considering the high prevalence of obesity its comorbidities in Brazil and in the world,~     different therapeutic measures have been suggested. It is currently known that brown/beige~     adipose tissue plays an important role in body weight control and there is strong evidence~     that its activity is inversely associated with obesity and metabolic diseases. Recent~     studies have shown an important role foods and nutrients in the activation of brown/beige~     adipose tissue, almost exclusively in animal models. The benefits of monounsaturated fatty~     acids to metabolism have been described in several studies, however, the effects of~     consuming large amounts of olive oil in the activity of brown/beige adipose tissue in humans~     have not been explored. The aim of the study is to evaluate the impact of the consumption of~     large amounts of extra virgin olive oil in the activity of brown/beige adipose tissue in~     lean and obese humans. This will be a clinical trial with a total duration of 4 weeks. Obese~     and controls (normal weight) participants will undergo a dietary intervention for 4 weeks~     with extra virgin olive oil. Before and after the intervention period several data will be~     collected: dietary intake and physical activity data, evaluation of brown/beige adipose~     tissue (with 18F-fluorodeoxyglucose positron emission tomography and magnetic resonance~     imaging - PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory~     markers as well as hypothalamic inflammation (functional magnetic resonance imaging) and~     brown adipose tissue biopsies in a subsample of 20 participants. The data will be expressed~     as mean and standard deviation and the variables compared by the Student t test or ANOVA for~     repeated measures.~   "
2510|NCT03024346|"~     Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway~     Volumes and Resistance With Moderate to Severe COPD.~   "
2511|NCT03024333|"~     This study is aimed to establish and identify the normal pattern of swallowing sounds and~     analyze swallowing sounds of different textured foods and viscous liquids in healthy~     subjects to provide clinical evidence to update dysphagia patients' food.~   "
2512|NCT03024320|"~     The study uses a theory-driven eHealth platform and innovative physical activity (PA)~     program referred to as movement-to-music (M2M) to deliver a customized, home-based PA~     intervention for adults with physical disability (PWD). Participants will be recruited~     through a large physical medicine and rehabilitation network of clinics specializing in~     treating patients with physical disability. Clinicians and their patients will be cluster~     randomized to one of three groups: a) M2M; b) M2M plus social networking (M2Mplus); and c)~     attention control (AC). Participants will be followed for 48 weeks to obtain objective~     measures on physical activity, fitness and self-reported measures on health at four time~     points. Participant physicians will receive information on their patients' progress (i.e.,~     adherence and outcomes) across the 48-week study period. The study will compare the~     effectiveness of M2M and M2Mplus in increasing physical activity and adherence compared to~     the AC group, estimate the improvements in health of M2M and M2Mplus compared to the AC~     group, and examine the mediators and moderators of the hypothesized treatment effect to~     understand for whom and how the intervention is effective. This multi-level, scalability~     study will strengthen our understanding of the potential benefits of eHealth to eliminate~     barriers to PA participation among PWD.~   "
2513|NCT03024307|"~     This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services~     Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic~     diseases.The purpose of this study is to evaluate:~        1. rates of medication adherence in the OPCSP program compared with usual care in an~          integrated health care system.~        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care~          in an integrated health care system.~   "
2514|NCT03024294|"~     The goal of this study is to create a unified SOP for care of subjects undergoing VATS~     lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic~     centers have created standardized algorithms for the care of their subjects and this enables~     the centers to determine which subjects can be placed on an accelerated pathway to discharge~     and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in~     what may be unnecessary tests to simplify patient care and likely accelerate them towards~     safe and more timely discharge from the hospital.~   "
2518|NCT03024242|"~     Bivalve vaginal speculum insertion is a basic final step of vaginal examination.~     Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow~     vagina, women with vaginismus or patients with a history of previous vaginal surgery. In~     such cases, the value of vaginoscopy (examination of the vagina without speculum) is~     evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected~     vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal~     wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic~     review, the effectiveness and feasibility of using hysteroscopy for exploration of the~     immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and~     treatment of gynecologic disorders in adolescent patients with an intact hymen, limited~     vaginal access, or a narrow vagina. Another recent systematic review highlighted the~     importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an~     important tool with which to diagnose and treat vaginal lesions.~      In practice, we notice leakage of excessive irrigating fluid per vagina with poor~     visualization during vaginoscopy. To the best of our knowledge, no study addressed a~     solution to improve visualization and success of vaginoscopic surgery. This study aims to~     test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy~     if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic~     surgery in patients with vaginal or cervical lesions.~   "
2519|NCT03024229|"~     The quality of the renal transplant prior to transplantation is essential for the recovery~     of graft function in the days following transplantation and its long-term survival. When the~     kidneys are perfused on perfusion machines before transplantation, the resistance parameters~     as well as the histological score on the pre-implantation biopsy participate in the~     evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could~     provide additional evidence.~   "
2520|NCT03024216|"~     The purpose of the study is to compare the safety and tolerability of sequential~     atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm~     2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not~     previously treated with docetaxel or cabazitaxel.~   "
2521|NCT03024203|"~     Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for~     individuals with psychosis, however, there is no gold standard method of cognitive~     remediation available. Cognitive training refers to the training component of CR in which~     people practice computerized exercises that train specific cognitive abilities. There is no~     agreed upon approach within the field as to the type of training that is most effective with~     some studies, training higher level cognitive abilities, some training perceptual abilities,~     and others training general cognitive skills. This study will directly compare two competing~     methods of cognitive training on measures of neurophysiology, neurocognition, functional~     competence, and real-world functional performance.~   "
2522|NCT03024190|"~     Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a~     brain injury leading to limbs weakness and impaired coordination between agonist and~     antagonist contraction. PSS leads some physical impairments and functional deficits. The~     clinical managements for PSS are stretching and range of motion (ROM) exercises,~     antispasticity splint, neuromuscular electrical stimulation, oral medications, local~     injection with phenol or botulism, or surgery. Recently, some investigators tried to use~     Kinesiotaping (KT) for spasticity management or postural control. They found some benefits~     in walking ability and upper extremity function facilitation after stroke.~      40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40~     patients will be randomly divided into the experimental and control groups. In experimental~     group (n=20), the patients will perform combined KT and 15- min stretching exercise for~     upper extremity twice daily and regular rehabilitation program for 3 weeks. In the control~     group (n=20), the patients will perform 15- min stretching exercise for upper extremity~     twice daily and regular rehabilitation program for 3 weeks. Before intervention, immediately~     and 2 week post intervention, all patients will receive associated physical examinations,~     hand function evaluations, and sonography.~   "
2523|NCT03024177|"~     This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of~     laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in~     allogeneic and autologous stem cell transplant subjects. The aim of this study is to~     evaluate the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract~     infection in HSCT patients, as measured by viral load changes, worsening of upper~     respiratory tract infection (URTI) to lower respiratory tract infection (LRTI), duration of~     clinical symptoms, the occurrence of supplemental oxygen use, duration of viral shedding,~     hospital admission and duration of hospitalization, incidence of secondary bacterial~     infection, and mortality rates. Additionally, the safety and tolerability of vapendavir, and~     the vapendavir plasma levels achieved in the HSCT population, and the profile of viral~     resistance development will also be assessed.~   "
2524|NCT03024164|"~     The main purpose of this study is to build the study cohort of young ischemic stroke~     population in China, and to compare the prognosis of patients with different ischemic stroke~     subtypes.~   "
2525|NCT03024151|"~     The goal of this research is to compare the effects on psychological distress between T4~     mono replacement group and T4/T3 combination replacement group after total thyroidectomy in~     thyroid cancer patients.~        1. Subjects:~             -  Psychologically distressed patients, such as depression, anxiety, and fatigue~               patient after total thyroidectomy with thyroid cancer are considered for~               participation. Screening of distress after total thyroidectomy is used HADS~               (Hospital Anxiety and Depression Scale) ≥ 8 for depression and anxiety, and~               MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.~        2. Randomization:~             -  Using the table of random sampling numbers, patients assign to T4 mono replacement~               group or T4/T3 combination replacement group.~        3. Evaluation for distress:~             -  Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate~               change of psychological distress (depression, anxiety, and fatigue). Level of~               distress after thyroidectomy will determine using Hospital Anxiety and Depression~               Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for~               depression and anxiety, and Brief Fatigue Inventory (BFI) for fatigue.~   "
2526|NCT03024138|"~     Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment~     of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer,~     and (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for~     the treatment to be effective. However, this accuracy is compromised by tumour and organ~     motion. Radiotherapy treatment planning is typically performed on a planning-CT scan~     recorded several days prior to commencement of radiotherapy. Inter-fraction set up~     variations and organ motion during treatment can lead to differences between the calculated~     dose distribution on the planning-CT and the radiation dose actually received by the tumour~     and normal organs. Accurate assessment of these effects is essential to determine optimal~     margins in order to irradiate the tumour adequately while minimizing the dose to the organs~     at risk (OARs).~      In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non)~     Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables~     marked reductions of the radiation dose to the OARs and thus decreasing the risk of~     radiation induced cardiac and lung toxicity. However, for PBT using pencil beam scanning~     (PBS), knowledge of tumour and organ motion will be even more important. The potential major~     advantages of PBS for tumours in the thoracic region are challenged by the respiratory~     motion of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors~     and inter- and intra-fraction organ motion cause geometric displacement of the tumours and~     normal tissues, which can cause underdosage of the target volumes and overdosage of the~     organs at risk. Furthermore, it can result in changes in tissue densities in the beam path,~     which can alter the position of the Bragg peaks and lead to distorted dose distributions. If~     pencil beam scanning techniques are used to treat moving tumours, there is interplay between~     the dynamic pencil beam delivery and target motion. This phenomenon can cause additional~     deterioration of the delivered dose distribution, usually manifesting as significant local~     under and/or over dosage. It is therefore essential to incorporate motion-related~     uncertainties during treatment planning.~      The main objective of this study is to evaluate the impact of inter-fraction tumour and~     organ motion - while taking into account intra-fraction movements appropriately - on photon~     and proton radiotherapy treatment planning in order to yield robust intensity modulated~     photon and/or proton treatment plans.~      Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation~     for moving tumours on photon and proton radiotherapy treatment plans in order to create~     robust intensity modulated photon- and/or proton treatment plans.~      Study design: Pilot-study (80 patients).~      Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer~     ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with~     radiotherapy (with or without chemotherapy) with curative intent.~      Intervention (if applicable): Not applicable.~      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of~     clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose,~     MHD) and the lungs (mean lung dose, MLD).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat~     planning CT scans in treatment position without contrast agents in order to evaluate the~     impact of inter-fraction tumour and organ motion.~      Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the~     intra-fraction motion.~      The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10~     x 7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose~     (40-60Gy). The risks are therefore negligible and the burden is low.~   "
2528|NCT03024112|"~     The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on~     the rate of post-operative pulmonary complications in thoracic surgical patients. The~     Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen~     treatment, will reduce the incidence of postoperative pulmonary complications, improve~     post-operative pulmonary function, and reduce ICU and hospital length of stay.~   "
2529|NCT03024099|"~     The hippotherapy is considered a therapeutic modality that provides numerous benefits in the~     rehabilitation process and has often been recommended by doctors for children with cerebral~     palsy. Despite being in frank ascent, this therapy still lacks scientific evidence.~     Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a~     week in gross motor function, trunk balance and functional performance of children with~     cerebral palsy.~   "
2530|NCT03024086|"~     The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of~     Functional Dyspepsia.~   "
2531|NCT03024073|"~     Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses~     implantation are supposed to have sufficient uncorrected vision capacity for activities of~     daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is~     known that light intensity and temperature has a great impact on near vision capacity.~     Primary objective of this study is to identify the optimal task lighting conditions (in~     terms of light intensity and temperature) for ADLs that demand near vision acuity for a~     sample oa patients who underwent presbyopic correction with bilateral bifocal intraocular~     lenses implantation~   "
2532|NCT03024060|"~     The purpose of this study is to prove the safety and efficacy of Levulan Kerastick~     (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light~     delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the~     face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.~   "
2533|NCT03024047|"~     Background:~      Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness~     of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may~     be lifesaving.~      AV-block in younger can be seen along with structural or ischemic heart disease, congenital~     heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases,~     sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen~     in conditions, primarily localized to the AV-node without other cardiac disease at~     diagnosis.~      This form of AV-block is often hereditary and can be seen in families where relatives have~     another types of heart disease in form of fore example, cardiomyopathy, ion channel disease~     or sudden death. The different forms of presentation are due to the same gene mutation being~     expressed differently within the same family. Thus, early onset of AV-block (<50 years) may~     indicate hereditary AV-conduction disorder but it can also be the first manifestation of~     severe ion channel disease or cardiomyopathy.~      Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced~     AV-block. There have been no overall figures regarding the causes of advanced AV-block, and~     therefore no systematic approach to diagnosing this group of patients. Furthermore, the~     prevalence of individuals with a genetic cause of AV-block is unknown and presumably an~     often overlooked diagnosis among younger patients with advanced AV-blok. There are no data~     on disease progression after diagnosis, and therefore there is no evidence-based knowledge~     about how these patients should be followed after diagnosis.~      With modern gene technology, a range of new, yet unknown genes with potentially pathogenic~     mutations is likely to be identified. Identification of such genes, and the development of a~     strategy for systematic approach to diagnose younger patients with AV-block, will enable~     presymptomatic genetic screening of relatives and implementation of evidence-based,~     preventive treatment with pacemaker and/or medical treatment for heart failure based on a~     specific genetic predisposition for development of AV-block with or without heart failure.~      Hypotheses:~      In a significant proportion of younger patients with advanced AV-block the underlying cause~     is unknown.~      Objective:~      To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark~     and describe the current diagnostics.~      Method:~      The study is a cross sectional study. The patients for this study are identified from Danish~     Pacemaker and ICD Register. The investigators will review medical records and obtain~     clinical information and test results (see detailed description).~      Perspectives:~      This study is the first part of a large study of AV-block in younger patients in Denmark.~     The overall goal, is to increase knowledge about the causes of and disease progression after~     the diagnosis of advanced AV-block in young patients which could lead to a significant~     improvement in the treatment of this patient group and may lead to a customized choice of~     pacemaker type in the future and perhaps additional medical treatment in this patient group.~     This could potentially lead to a reduction in both their morbidity mortality.~   "
2534|NCT03024034|"~     The purpose of this study is to determine the safety and tolerability of up to 6 different~     single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male~     or female subjects.~   "
2535|NCT03024021|"~     This study is designed to assess the effect of cerebral oxygen saturation as an early~     predictor of neurological outcomes in patients undergoing therapeutic hypothermia after~     cardiac arrest~   "
2536|NCT03024008|"~     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II~     as an autologous bone-regenerating graft in the reconstruction of deficient bone in two~     clinical indications:~        1. Long bone extra-articular comminuted fracture~        2. Large bone defect or gap incapable of self-regeneration~   "
2537|NCT03023995|"~     Over the years, numerous surgical techniques such as free autografts and pedicle grafts have~     been introduced to correct gingival recession defects. Combination grafts with either~     autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet~     concentrates, etc., were developed more recently to correct mucogingival defects. The use of~     PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus~     floor segmentation during implant placement and on facial plastic surgeries have shown~     promising results. However to our knowledge, till this study was completed, no studies have~     been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the~     treatment of localized gingival recession defects.~      Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin~     membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and~     Class II gingival recession defects.~   "
2538|NCT03023982|"~     A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus~     nerves block) has been described for pain control after thoracic surgery, one of the~     indications to perform this method is analgesia for surgeries or procedures involving~     lateral chest wall~   "
2539|NCT03023969|"~     Low back pain is very common problem, variable modalities have been introduced to control~     such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that~     could reduce the herniation disk size and inflammation.~   "
2540|NCT03023956|"~     From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were~     treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck~     fractures (SNF), we divided the patients into two groups. All the patients were followed at~     least 1 year.~   "
2541|NCT03023943|"~     The research design will be single group pretest-posttest design. The subject will be~     instructed to position the knee joint to a position previously set by the experimenter.~     Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep~     technique.~   "
2542|NCT03023930|"~     The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF)~     on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP)~     treatment with referral for ongoing medication-assisted treatment (MAT) and the (2)~     effectiveness of IF on patient engagement in formal addiction treatment at 30 days.~   "
2543|NCT03023917|"~     The overall objective of the present study is to examine the effects of umbilical cord~     milking at birth in preterm infants to prevent and decrease anemia using a multi-center~     prospective randomized controlled trial comparing immediate cord clamping (standard at~     present) with umbilical cord milking.~   "
2544|NCT03023904|"~     This phase II trial studies how well nivolumab works in treating patients with stage IV lung~     cancer or that has come back after initial treatment who has high mutation loads. Monoclonal~     antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain~     cells.~   "
2545|NCT03023891|"~     This study evaluates the effect of acute administration of oral prednisone in white blood~     cells counts and glucose tolerance and the relationship of these measures with changes in~     gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene~     expression will be study before and after prednisone administration.~   "
2546|NCT03023878|"~     A phase 2, multicenter, open-label, single arm clinical trial in adult subjects with newly~     diagnosed aggressive high-risk DLBCL.~   "
3374|NCT03013062|"~     Since the pulmonary artery hypertension is defined based on MPAP and the two previous~     formulae relating MPAP and PAT were derived in western population, the investigator planned~     to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian~     population and compare the accuracy of all the three formulae~   "
2547|NCT03023865|"~     The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most~     challenging congenital malformations in neonatal surgery. Usually the proximal and distal~     segments of the esophagus are too far apart, which leads to primary anastomosis abandoned.~     Thus various techniques have been used including Circular and spiral myotomies、Foker and~     Kimura elongation and gastrointestinal replacement. They are being widely used but bring~     more complications and less effectiveness. And considering about the absence of definite~     guideline for the diagnosis and treatment of LGEA worldwide, We prepare to use a~     preoperative staged stress function procedure for elongation of the proximal and distal~     segments, then to obtain an exact evaluation of the pouch status to achieve an~     individualized protocol of diagnosis and treatment utilizing the native esophagus to~     establish esophageal continuity for patients with LGEA.~   "
2548|NCT03023852|"~     The purpose of this study is to assess the rate and extent of absorption of JNJ-63623872~     following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept~     single agent tablet formulations compared to the administration of 2*300 mg JNJ-63623872~     reference tablets, under fasted conditions in healthy adult participants and to assess the~     rate and extent of absorption of JNJ-63623872 and oseltamivir following administration of a~     single oral dose of 2*300 mg/37.5 mg JNJ-63623872/oseltamivir given as a concept fixed-dose~     combination (FDC) tablet formulation compared to the coadministration of 2*300 mg~     JNJ-63623872 tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted~     conditions in healthy adult participants.~   "
2549|NCT03023839|"~     Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes.~     There is little information on delirium in injured patients however. This study determined~     the incidence and risk factors for delirium in severely injured patients.~   "
2550|NCT03023826|"~     The purposes of this study are to determine:~        -  If there are any differences in the way LY3202626 is handled by the body when taken in~          two different forms~        -  Whether a high fat meal affects the way the body handles LY3202626~        -  How well tolerated LY3202626 is~      There are three (3) study periods for all participants. Participants will be admitted to the~     clinical research unit (CRU) each period and will be discharged from the CRU following the~     completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.~      The study will last about 50 days, not including screening.~   "
2551|NCT03023813|"~     The primary objective of this study is to help patients compare the benefits of various~     preventive care services, based on their individual risk factors (such as smoking status,~     obesity, high blood pressure, high cholesterol, etc.). Tailored decision aids will be~     provided to each participant during primary care appointments to facilitate discussion~     between the participant and his/her provider regarding prioritizing preventive service~     recommendations.~   "
2552|NCT03023800|"~     Macular schisis associated with macular detachment is a one of the complications of high~     myopia. There is controversy in the primary treatment for this situation. This study will~     compare the effects of macular buckling + gas injection versus vitrectomy + internal~     limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular~     retinal detachment associated with macular hole.~   "
2553|NCT03023787|"~     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical~     pharmacokinetics in healthy volunteers.~   "
2554|NCT03023774|"~     Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment~     of thin endometrium or in women with recurrent implantation failure in ICSI cycles~   "
2555|NCT03023761|"~     In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain~     after irradiation of low level laser therapy~   "
2556|NCT03023748|"~     This study aims to provide intravenous paritcalcitol treatment for the sick and poor~     hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing~     vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D~     analogs.~      The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical~     parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular~     calcification and stiffness parameters and nutrition status in patients receiving chronic~     hemodialysis treatment.~   "
2557|NCT03023735|"~     The goal of this study is to better understand how clinicians give genetic risk information~     to patients from multi-ethnic groups and how patients understand this information and~     remember it and act upon it. In addition investigators want to know how to better~     communicate with patients about complex health issues across the health literacy divide and~     communication gap that exists between doctors and their patients.~   "
2558|NCT03023722|"~     The primary objective of this study is to:~      -Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients~     with advanced pancreatic cancer who stain for mesothelin expression~      The secondary objectives of this study are to:~        -  Time to Progression (TTP) defined as time from study treatment to RECIST 1.1~          progression, or death (others going off study will be censored)~        -  Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)~   "
2559|NCT03023709|"~     The investigators collected blood and lymphoid tissues routinely discarded during surgery~     from adults after a routine seasonal influenza vaccination to determine how immune memory~     develops at the actual site of infection, and how immunization may alter this process.~   "
2572|NCT03023540|"~     All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary~     study CLN-PXT3003-02, i.e. 15-month double-blind treatment with PXT3003 or placebo, will be~     eligible to continue in the extension study CLN-PXT3003-03.~      Patients randomised to PXT3003 dose 1 or 2 in the primary study (CLN-PXT3003-02) will~     continue in the extension study at the same dose, while the patients who received placebo~     will be assigned to one of the two active doses by a second randomization at the entry in~     the extension study.~   "
2638|NCT03022682|"~     Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the~     proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is~     associated with increased mortality through its linkage to comorbidities including diabetes,~     hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given~     its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of~     obesity and its consequences is one of the most important problems of our time.~   "
2560|NCT03023696|"~     C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression~     surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the~     deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of~     life. Furthermore, about half of patients with C5P present with sensory deficits and/or~     intractable pain in addition to the muscle weakness.~      Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery~     has been studied recently with the hope that it will minimize the risk of developing a C5~     nerve root palsy postoperatively. Although the current literature provides some support for~     this claim, there are insufficient data establishing this technique as a proven measure to~     reduce the incidence of C5P. In the present study, we seek to evaluate the effect of~     bilateral foraminotomy on postoperative C5P incidence rates.~      Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following~     cervical decompression surgery, but an identical foraminotomy procedure has never been~     applied in a randomized manner to all qualifying patients in a study. Additionally,~     prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the~     proposed study, bilateral foraminotomy will be randomized to patients receiving cervical~     decompression surgery (laminoplasty, laminectomy, fusion). Patients undergoing cervical~     decompression surgery will be consented and enrolled if they meet the inclusion and~     exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy~     of prophylactic C5 bilateral foraminotomy during cervical decompression.~   "
2561|NCT03023683|"~     The purpose of the study is to investigate and compare the human immune response in~     epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza~     vaccine (LAIV) in adults and in children.~   "
2562|NCT03023670|"~     The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung~     perfusion is maintained solely by the bronchial arterial system~   "
2563|NCT03023657|"~     Severe brain injuries lead to disorders of consciousness after coma. During this awakening~     period, detection of arousal is critical to the adaptation of medical strategy, but global~     paralysis, including facial expression, make the clinical assessment very difficult.~     Emotional facial expressions are a significant part of this clinical assessment. They are~     both a landmark of the internal state of the patient (comfort versus discomfort) and a~     landmark of the relational level with his environment. Visible emotional facial expression~     is a large temporal phenomenon lasting a couple of seconds, while a microexpression is~     barely noticeable and very brief. These micro expressions are usually produced when one~     tried to voluntary hide emotional expressions. In this study, we hypothesize that some~     patients awakening from coma could still produce microexpression before being able to~     produce visible emotional facial expressions. This ability to produce micro-expression could~     be an early landmark of relational awakening in severe brain lesions.~   "
2564|NCT03023644|"~     Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD),~     making it the most common birth defect. With recent medical advances, more children with CHD~     survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with~     CHD. These survivors face challenges in terms of their cognitive and behavioral development.~     For many, the limitations affect their academic achievement, social adaption and,~     ultimately, their quality of life. Among the most disabling limitations are those that~     pertain to the ability to maintain attention, plan and organize activities, regulate~     emotions, and develop problem-solving strategies. Collectively, these are referred to as~     executive functions (EF) because they are higher-order abilities that enable one to~     coordinate complex behaviors. Additionally, impaired EF also underlie mental health~     disorders. In spite of the abundance of evidence that children with CHD struggle with EF,~     there is little to offer them in the way of evidence-based interventions to prevent or~     mitigate these problems.~      The investigators propose to conduct the first randomized trial to evaluate the efficacy of~     an intervention, the Cogmed Working Memory Program, in improving the neurodevelopmental~     outcomes of children with critical CHD after infant open-heart surgery. Children who meet~     eligibility criteria and who agree to participate will be randomly assigned to an~     intervention or control group. Children in the intervention group will complete 25 35-40~     minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of~     home-based, child-friendly, computerized activities. The control group will receive the~     standard of care for children with CHD. Children's scores on EF and related~     neurodevelopmental tests will be evaluated before the intervention group completes Cogmed~     training, at the conclusion of their training, and 3 months later. The latter assessment~     will indicate whether any gains in EF skills of the children in the intervention group are~     sustained after training. Parents and teachers will also complete questionnaires about~     children's EF, attention, and social behaviors to determine whether training affects~     behaviors of the intervention group at home and in school. The investigators will also~     identify the medical and surgical characteristics of children who benefit most from Cogmed~     training. This information will be helpful in targeting the intervention most efficiently in~     the future.~   "
2565|NCT03023631|"~     The goal of this clinical research study is to learn if Gardasil (the HPV vaccine) can~     prevent HPV infection and HPV-related disease when given to blood cancer patients who have~     received a stem cell transplant.~   "
2566|NCT03023618|"~     In this before and after study we will investigate the potential benefit on postoperative~     outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has~     been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards).~     In the postoperative period overall complications, as well as exitus , will be analyzed and~     compared with those of a control group underwent the same surgical interventions, with a~     standard hemodynamic monitoring.~   "
2567|NCT03023605|"~     The purpose of this study is to analyze the clinical impact of an educational intervention~     on adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a~     standardized training, for improving diagnostic sensibility and reducing unnecessary scans,~     adverse effects and stays in the ED.~   "
2568|NCT03023592|"~     A single-center, self-control, open-label study of efficacy and safety of Iguratimod in~     patients with Sjögren's Syndrome~   "
2569|NCT03023579|"~     PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),~     and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children~     with cerebral palsy (CP).~      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in~     this study. Each child carried out the SEBT and was assessed by two examiners. To determine~     intra-rater reliability, the investigators calculated the intra-class correlation~     coefficient (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to~     determine the inter-rater reliability.~   "
2570|NCT03023566|"~     The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in~     pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix~     Children's Hospital.~   "
2571|NCT03023553|"~     This study will examine the immune responses to the seasonal influenza vaccine in single~     cells of the nasal passages when compared with cells in circulating blood.~   "
2573|NCT03023527|"~     This is an open-label, non-randomized Phase 1 study evaluating the role of two regimens:~      A) Nivolumab in combination with Pomalidomide and low dose dexamethasone and B) Nivolumab +~     Elotuzumab + Pomalidomide + dexamethasone in the treatment of relapse or refractory multiple~     myeloma patients.~      The study will be performed in 10 sites in Spain. First, the MTD for the Nivo-Pom-Dex~     combination will be determined using a 3+3 scheme. Once the MTD has been determined both~     Regimes (A and B) will be open for full accrual and patients will be included in an~     alternating way in both regimes simultaneously. In the case that an unacceptable toxicity~     was seen in the Lead-in phase (Nivolumab + Pomalidomide + low dose dexamethasone), the other~     phase would not be open.~      A safety analysis by an internal review committee will be performed once the first six~     patients included in the regimen B have completed the first two cycles.~      The main purpose of the study is to analyze the proportion of subjects, with refractory or~     relapsed multiple myeloma, receiving the combination Nivo-Pom-dex or Nivo-Pom-dex-Elo~     experience one or more haematological and non haematological SAE (grade 3 or higher).~      Additionally, other~      Research Hypothesis:~      The combination of nivolumab with pomalidomide and dexamethasone will demonstrate adequate~     safety and tolerability to permit further testing of these combinations in subjects with~     multiple myeloma. The addition of elotuzumab to nivolumab, pomalidomide and dexamethasone~     will not change the safety profile.~      Duration of Study:~      The study will remain open for enrolment for 15 months (estimated), or until the planned~     total number of 40 subjects is reached if this happens first.~      The follow-up of the last recruited patient will be up to 3 years, being the Final analyses~     performed 1,5 years after the last patient is included.~      Study Population:~      Male and female adult patients with Multiple Myeloma in first or subsequent relapses,~     previously exposed to both a proteasome inhibitor and a IMID (Lenalidomide). Patients may be~     exposed, relapsed or refractory to Lenalidomide.~   "
2574|NCT03023514|"~     Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to~     the success of embryo implantation phase, because it exerts, directly or indirectly, an~     immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that~     facilitate embryo implantation, and to stimulate the production of local mediators useful~     for implantation. This study is a prospective clinical trial and aims to evaluate the~     reproductive outcomes of Italian couples following oocyte donation fresh cycles when~     receiving per os tablets of lipoic acid. Indeed, the control group had only the standard~     treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA~     (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the~     pregnancy test. If the childbearing occurred, treatment continued until the 8th week of~     pregnancy. Primary outcome of the study is the implantation rate while the positive hCG~     rate, the clinical pregnancy rate, the miscarriage rate and the live-birth rate are~     secondary outcomes .~   "
2575|NCT03023501|"~     The evidence regarding effects of pain modulator like gabapentin on postoperative pain after~     sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative~     opioid-sparing properties.This study will highlight the effectiveness of preoperative use of~     gabapentin for postoperative pain management in morbidly obese patients.~   "
2576|NCT03023488|"~     Aim of this study is to investigate the effects of increased intrarenal pressure during~     flexible ureteroscopy on renal blood flow.~      Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones~     according to European Association of Urology (EAU) guidelines on Urolithiasis will be~     included in the study after having signed an informed consent form. The pre- and~     post-operative evaluation and management will be performed according to EAU Guidelines on~     Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be~     performed to patients pre- and post-operatively. The pre-operative Doppler US will be~     performed 2 days prior to surgery and the post-operative Doppler US will be performed in the~     first 24 hours following surgery. The changes on blood flow in renal artery and arcuate~     artery will be recorded.~   "
2577|NCT03023475|"~     Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the~     investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust~     GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting~     is performed in the standard fashion according to the institutional routine. The patients~     are randomized preoperatively to one of the devices. The proximal end of the radial artery~     will be preserved and deep-frozen for histological assessment. Endothelial integrity will be~     investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.~   "
2578|NCT03023462|"~     One of the most common complications after hernia repair is postoperative and chronic pain.~     TAP (transverse abdominis plain) block is a recommended multimodal method of reducing~     postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this~     study is to determine whether the use of a perioperative echo guided unilateral TAP block~     has a superior effect on postoperative pain after laparoscopic inguinal repair compared to~     the inguinal field block with a long acting local anesthetic.~   "
2579|NCT03023449|"~     This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral~     blood flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and~     healthy subjects. The monitoring is a 35 minute session during which cerebral hemodynamics~     will be monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler~     ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate,~     end oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration,~     are continuously monitored.~   "
2580|NCT03023436|"~     This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined~     with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.~   "
2581|NCT03023423|"~     The purpose of the study is to compare the overall response rate (ORR) in non-small cell~     lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab~     versus atezolizumab alone.~   "
2597|NCT03023215|"~     The goal of this behavioral research study is to learn if taking part in guided relaxation~     programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will~     also examine whether the guided relaxation programs change brain activity, heart rate, and~     blood pressure.~   "
2598|NCT03023202|"~     This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor~     Board, and to track patient outcomes.~   "
2639|NCT03022669|"~     The purpose of this study is to determine whether text messages/messaging (TM) or a mobile~     application (app), compared with an educational website-control provided to all Veterans,~     can improve adherence to antiplatelet therapy among patients following acute coronary~     syndrome or percutaneous coronary intervention (ACS/PCI).~   "
2895|NCT03019315|"~     Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The~     benefit of standard chemotherapeutic regimens including taxane has not been established.~     This study was conducted to investigate the influences of regimens of front-line~     chemotherapy on on recurrence and survival for early-stage ovarian adenocarcinoma. Further,~     the study will analyze cost-effectiveness of different regimens~   "
2582|NCT03023410|"~     This study will attempt to draw relationships between the soft-tissue related complications~     contributing to early TKA revision and the loading and positional patterns from~     intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to~     address such soft-tissue abnormalities that may otherwise be unknown during traditional~     total knee revision procedures. The utilization of sensors should in theory, help diagnose~     the potential causes attributing to soft-tissue imbalance and may lead to a decreased need~     for an all component revision. Furthermore, the economic implications from converting a~     total revision to a partial revision could have a profound effect to the patient and~     healthcare provider such as decreased rehabilitation regimes and opportunity for cost~     savings. Eligible revision patients who agree to participate will be followed for a period~     of 12 months following the revision procedure. Patient reported outcomes measures (PROM)~     such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey~     (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12~     months post-procedure. All outcomes will be scored to observe changes from baseline at~     12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR~     costs, facility and physician fees, as well as payments to post-acute collaborators such as~     SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial~     payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated~     with traditional revision TKA procedures.~   "
2583|NCT03023397|"~     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation~     following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract~     in e-cigarette users, cigarette smokers, and non-smokers.~   "
2584|NCT03023384|"~     Create a network of institutions in developing countries that will perform AML diagnosis,~     risk classification, treatment, supportive care and follow-up evaluation according to a~     common protocol and will register data using common clinical research forms (CRFs) in a~     single database and available on the internet.~   "
2585|NCT03023371|"~     The aim of this study is to establish a nation-wide cohort study of IgG4-related disease~     (IgG4-RD) in China.~      Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled~     from multi-centers around China. A online database system has been established.~      Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese~     IgG4-RD patients; the secondary endpoints including the demographic features,laboratory~     characteristics, immunological tests, imaging and pathological features, in addition, the~     treatment and prognosis of the disease.~   "
2586|NCT03023358|"~     The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell~     NHL. This is largely due to lower response rates and less durable responses to standard~     combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the~     prognosis for PTCL.~   "
2587|NCT03023345|"~     The purpose of this study is to determine if trans-rectal microwave ablation of the index~     tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using~     MRI-transrectal ultrasound image registration.~   "
2588|NCT03023332|"~     How do varying levels of participation in selecting self-management interventions (ranging~     from no input into the selection to selection based on need or preference) affect health~     risks and physical and mental health over time in family caregivers of persons with bipolar~     disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2)~     education (usual care); 3) self-management intervention based on need (SM-need); or 4)~     self-management intervention of their preference (SM-preference).~   "
2589|NCT03023319|"~     This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in~     combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that~     can be given without causing severe side effects. This study will also test the safety of~     this combination and see what effects (good or bad) it has on participants and their cancer.~   "
2590|NCT03023306|"~     Female patients aged between 20 and 70 years, ASA physical status I-II, and scheduled for~     thyroidectomy under general anaesthesia will be enrolled in the study.~      Patients will be randomized to the preemptive group to receive an antiemetic regime the day~     before surgery or to the intraoperative group to receive the same antiemetic drugs in the~     same doses intraoperatively.~      In the operating room standard monitoring and a standardized anesthetic technique will be~     implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be~     recorded immediately after extubation and six hourly thereafter for the first 24 hours. Pain~     scores assessed by VAS (verbal analogue scale) will be recorded at the same time points.~     Also, if patients received fluids and solid food by mouth.~   "
2591|NCT03023293|"~     The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in~     regulating the glucose metabolism in GDM patients.~   "
2592|NCT03023280|"~     Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be~     present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus~     sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard~     treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to~     concerns of stricture formation. Therefore, the investigators aimed to investigate the~     effect of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the~     treatment of large symptomatic CIP.~   "
2593|NCT03023267|"~     The current study will investigate the combination of the two modalities in a mixed-methods~     design, in order to provide comprehensive knowledge regarding the effects of family-centered~     MT during KC, on premature-infants' autonomic nervous system stability (measured by~     parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety~     levels; And parents' unique experiences of the intervention. Additionally, the study will~     analyze separately mothers and fathers to elucidate similar and different effects~   "
2594|NCT03023254|"~     To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis~   "
2595|NCT03023241|"~     To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial~     cystitis (BPS/IC) for diagnosis of this disease.~   "
2596|NCT03023228|"~     A learner-centered diabetes survival skills self-management education program was provided~     to adults with uncontrolled diabetes in the hospital and generated preliminary evidence of~     impact on medication adherence and a trend toward reduction in hospital and emergency~     department admissions.~   "
2599|NCT03023189|"~     Upper digestive bleeding Upper gastrointestinal haemorrhage is a common cause of cirrhosis's~     decompensation and is associated with a high mortality rate among cirrhotic patients. Its~     leading cause is the rupture of gastro-esophageal varices due to portal hypertension. In~     cirrhotic patients, the management of acute gastrointestinal haemorrhage is challenging as~     they often present with coagulation (or haemostasis abnormalities) abnormalities such as~     hyperfibrinolysis, especially when the cirrhosis is decompensated. Beyond life support~     measures, therapeutic modalities of variceal bleeding rely on both endoscopic and~     pharmacological interventions. Tranexamic acid (TA) is an antifibrinolytic that may help~     control the bleeding in this setting, as it showed an unquestionable benefit in other~     indications. TA has previously been studied both in upper gastrointestinal haemorrhage from~     any causes and in liver transplantation of cirrhotic patients. However, there is a lack of~     data to conclude on its effectiveness (or efficiency) in the early treatment of acute~     variceal bleeding in cirrhotic patients.~      Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic~     patients presenting with acute Upper gastrointestinal haemorrhage , by controlling the~     haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its~     administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic~     encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce~     indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in~     intensive care unit and the length of hospitalization, and decrease late relapses and~     one-year mortality.~   "
2600|NCT03023176|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
2601|NCT03023163|"~     The general population is aging, today 12% of the United States population is older than 65~     and it is estimated that by 2020 the number of people in the United States older than 65~     will outnumber children younger than 5. As the general population ages, the spinal cord~     injury (SCI) population is also aging and it is estimated that 14% is older than 60.~     Although persons with SCI are living longer, life expectancy remains below that of the~     general population with cardiovascular and cerebrovascular diseases accounting for more than~     25% of all deaths since 1995. Similar to findings in the general population, BP~     dysregulation may impact cognitive function, and investigators reported poorer performance~     on tasks of memory and attention processing in hypotensive individuals with SCI compared to~     a normotensive SCI cohort. Thus, it is imperative that investigators work to minimize the~     impact of cognitive deficits on these aspects of life quality in persons with SCI as they~     age. Therefore the goals of this study are: Study 1) to compare cardiovascular,~     cerebrovascular and cognitive function and fMRI between older individuals with SCI (50-75~     years) and older age-matched controls and Study 2) to determine 3-5 year longitudinal~     changes in cardiovascular, cerebrovascular and cognitive function and fMRI in relatively~     young individuals with SCI (28-54 years) compared to relatively young age-matched controls.~   "
2602|NCT03023150|"~     This study will be the first study to use ischemic preconditioning (IPC) as an intervention~     to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which~     has been shown to improve regional blood flow, motor neuron excitability and muscle function~     in multiple patient groups and in young, healthy subjects. Because IPC targets three~     physiological systems which are all affected by stroke, we hypothesize that repeated bouts~     of IPC during the first days to months following stroke (when the majority of recovery~     occurs) will make traditional rehabilitation strategies more effective.~   "
2603|NCT03023137|"~     This study is part of a big one aiming to evaluate how lifestyle interventions during~     pregnancy affect obstetric results, neonatal metabolism (NCT01409382) and the intelligence~     of the offspring (study not performed). The investigators decided to invite women with~     recurrent early miscarriages to participate in this study, for two reasons. The first one is~     that women with recurrent miscarriages are very likely to adhere to intervention protocols.~     The other reason is that no medication has been shown to increase the rate of take-home~     babies in women with early miscarriages who test negative for antiphospholipid antibodies.~      Trophoblast migration and placental vasculogenesis and angiogenesis depend on~     plasmin-dependent extracellular matrix remodeling. Plasminogen activator inhibitor (PAI)-1~     inhibits the generation of plasmin. Since both glucose and insulin increase PAI-1 synthesis,~     hyperglycemia itself, or by stimulating insulin production, reduces plasmin generation,~     which may impair placentation.~      Abnormalities in glucose metabolism may be also deleterious to embryos by causing epigenetic~     changes that may alter gene expression, increasing the risk of malformations. Chromosomal~     abnormalities are considered an important cause of early pregnancy losses.~      Several lines of evidence lend support to the hypothesis that carbohydrate metabolism~     abnormalities contribute to the pathophysiology of recurrent early pregnancy losses. One is~     the fact that among women with polycystic ovary syndrome, around 30 and 50% of the~     pregnancies end with first-trimester miscarriages. Hyperinsulinemia is a prevalent feature~     of the syndrome, and interventions proven effective in reducing insulin levels, such as~     metformin, have been shown to reduce the rate of early miscarriages. The other is that~     patients with body mass index of ≥25 kg/m2 have significantly higher odds of early~     miscarriage, regardless of the method of conception.~      The investigator's hypothesis was that a balanced diet combined to regular exercise, by~     improving glucose homeostasis, would increase the take-home baby rate in women with~     consecutive early miscarriages. Moderate exercises are usually well tolerated not only by~     the mother, but also by the fetus, as indicated by tests of fetal well-being, including~     umbilical artery systolic to diastolic ratio.~   "
2604|NCT03023124|"~     Phase II randomized study for the comparison of trabectedin versus doxorubicin plus~     dacarbazine in patients with advanced solitary fibrous tumor~   "
2605|NCT03023111|"~     Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony~     (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been~     described in up to 50% of patients, and the long period of 60 to 90 days required for~     healing of the ulcerated lesion indicate the need for alternative drugs. Currently the~     alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose~     use is limited either by toxicity or because, as with Sbv, the parenteral route hinders~     adherence and regularity of treatment in the rural area. Recent studies by our group~     indicate that oral miltefosine is the most effective drug for the treatment of patients with~     CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of~     71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory~     infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure~     rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the~     therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL~     caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.)~     guyanensis in the Amazon region.~   "
2606|NCT03023098|"~     The purpose of this study is to determine whether the use of drug-eluting balloons is~     effective in the treatment of (re)stenosis in bypass vein grafts.~   "
2609|NCT03023059|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in~     patients with Neovascular AMD, and measure the effects on visual acuity and retinal~     abnormalities due to wet (neovascular) AMD.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in~     patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular~     injections, and measure the effects on visual acuity, retinal abnormalities due to wet~     AMD, and document the number of anti-VEGF injections required during the study.~   "
2610|NCT03023046|"~     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,~     cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute~     lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as~     etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
2611|NCT03023033|"~     The goal of this proposed intervention study is to increase the proportion of HIV positive~     and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed~     infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion~     of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA)~     testing within 8 weeks of age.~   "
2612|NCT03023020|"~     The study compares two lengths of medication therapy (a shortened versus a prolonged dual~     antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the~     successfully treatment for coronary heart disease with a drug covered stent (metallic tube).~      This comparison will be done in patients who, compared to the average patient, are more~     likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are~     within the current medical recommendations. The aim of this study is to help improve further~     standard antiplatelet duration guidelines.~   "
2613|NCT03023007|"~     A non-randomized, mono-centric, prospective interventional study that will assess the~     efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a~     patient will have either received a mastectomy or a mastectomy associated with axillary~     nodes dissection, and/or a reconstruction by prosthesis.~   "
2614|NCT03022994|"~     Recently it has been reported that a consistent percentage of the general population~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have CD or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the~     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat~     causes the symptoms in NCGS patients, and the investigators also showed that these patients~     had a high frequency of coexistent multiple food hypersensitivity. Nowadays only few data~     are available on the histological characteristic of duodenal and rectal biopsies of NCWS~     patients. The researchers have just demonstrated a significant eosinophils infiltration of~     the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in~     the rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse~     gastrointestinal inflammatory/immunologic pattern. The aims of the present study are: 1)~     to investigate the histological characteristics in duodenal and rectal biopsies between NCWS~     and irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or~     rectal) shows inflammatory/allergic features useful for NCWS histological diagnosis.~   "
2615|NCT03022981|"~     This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.~      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm~     the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric~     participants with chronic hepatitis C virus (HCV) infection.~      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of~     SOF/VEL for 12 weeks in pediatric participants with chronic HCV.~   "
2616|NCT03022968|"~     Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/~     language presentation (logopenic progressive aphasia) 2/ visuospatial presentation~     (posterior cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes~     may precede the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been~     developed: biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration~     ßamyloid, molecular imaging with amyloid targeted PET ligands), biomarkers of neural~     degeneration (MRI hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG)~     and may be used to made early detection of the neuropathology associated with AD Even if CSF~     biomarkers (tau, p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot~     provide topographic information. PET tau imaging seems to be promise to evaluate~     quantitative and spatial assessment of tau lesions both in AD and fronto-temporal lobar~     dementia.~      The hypothesis of the research is that it exists a different regional pattern of tracer~     retention across brain regions according to clinical symptoms : temporal for logopenic~     aphasia and occipital for posterior cortical atrophy.~   "
2640|NCT03022656|"~     Brace treatment is the most effective non-surgical method for the treatment of Adolescent~     idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the~     high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with~     pressure pads installed inside the liner to provide mechanical support to the curvature of~     the spine. It is a big commitment for adolescents to wear a brace because it is physically~     restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to~     make the brace treatment as effective as possible to get patient buy-in to compromise their~     lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to~     attain their compliance.~      This randomized clinical study will investigate if the effectiveness of brace treatment can~     be maximized by combining ultrasound imaging assistance during brace design with the smart~     brace to automatically maintain corrective brace pressures at the optimum level during the~     whole treatment period.~   "
19162|NCT02806427|"~     This prospective observational study seeks to demonstrate the ability to meet nutritional~     needs of a calorically dense enteral formula in critically ill patients.~   "
2617|NCT03022955|"~     This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids~     on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional~     brain imaging will be applied to identify regions of brain that are activated or inactivated~     by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark~     chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their~     normal diet in randomized order. Reference standard methodology will be applied to measure~     gastric emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g,~     ~500kcal, ~50% fat) will be consumed with radio-opaque markers on three consecutive days. On~     the third day chocolate ingestion will be followed by measurements of postprandial brain~     activity using FDG-Positron Emission Tomography. Additionally colonic transit will be~     assessed based on the number and distribution of radio-opaque markers in the colon. On the~     fourth day gastric emptying and oro-caecal transit time will be assessed by scintigraphy~     after ingestion of a dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50%~     fat). During both interventional studies pre- and post-prandial satiety and dyspeptic~     symptoms, well-being and mood will be recorded. Additionally, validated questionnaires will~     assess digestive comfort and well-bring at the end of each study day. These results will~     deliver comprehensive information about the effects of cocoa on gastrointestinal transit and~     sensation.~   "
2618|NCT03022942|"~     To evaluate the acute and chronic effects of costal mobilization techniques and~     diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional~     capacity in patients with chronic obstructive pulmonary disease~   "
2619|NCT03022929|"~     Inappropriate antibiotic use is a major public health concern. Excessive exposure to~     antibiotics results in emergence and spread of drug-resistant bacteria, potentially~     avoidable adverse drug reactions, and increased healthcare utilization and cost. As~     antibiotic prescribing in emergency departments and urgent care centers remains unchecked,~     national professional organizations including the Infectious Diseases Society of America~     (IDSA) and the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the~     President of the United States, recommend expansion of antimicrobial stewardship to these~     ambulatory care settings. The goal of antimicrobial stewardship is to effectively promote~     judicious antibiotic use in all healthcare settings, yet stewardship programs have not~     achieved their potential in terms of either reach or effectiveness. Reach has been limited~     by implementation mostly in inpatient settings; at the same time, recent critical~     experiments in behavioral science suggest that the effectiveness of existing stewardship~     programs could be greatly augmented through inclusion of behavioral nudges, benchmarked~     audit and feedback, and peer-to-peer comparisons.~   "
2620|NCT03022916|"~     A recent publication using cadaver nails suggests that Jublia application has a negative~     effect on nail polish texture.~   "
2621|NCT03022903|"~     This research study will evaluate the safety and efficacy of using blue light photodynamic~     therapy (PDT) for treating toenail fungal infections.~   "
2622|NCT03022890|"~     The Specific Aims of this treatment development research are:~      To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education~     group (attention control) for persons with chronic pain who are taking methadone maintenance~     therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.~     Participants will be enrolled in the active intervention for 3 months, and then be followed~     for 6 months afterwards. Investigators' aims are:~        1. To assess feasibility and acceptability of both the yoga class and the health education~          control group. Investigators will assess credibility of the assigned intervention and~          expectancy for improvement for both groups at baseline, program satisfaction following~          program participation, participant adherence (class attendance rate and amount of home~          practice corresponding to assigned study arm), and instructor fidelity to the manuals.~          Investigators will conduct structured interviews following program participation to~          understand specific aspects of both programs considered attractive, useful, or not~          useful; we will solicit suggestions for improvements as well.~        2. To assess safety, investigators will track all adverse events in a structured fashion.~          Investigators do not expect to see any serious adverse events definitely or probably~          related to study participation.~        3. To assess feasibility of research procedures, investigators have benchmarks for~          recruitment rate, retention for study assessments, and reliability of instructor~          fidelity measures.~   "
2623|NCT03022877|"~     In the proposed project the investigators want to assess whether the approach of the~     post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can~     be used with a positive influence on the outcomes with respect to myocardial damage, cardiac~     left ventricular remodeling, myocardial function, the occurrence of cardiac events and~     quality of life.~   "
2624|NCT03022864|"~     Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The~     functional imaging of magnetic resonance can reflect the extent and character of pain~     exactly and the structural imaging of it can be a sign of the change. By analyzing fMRI~     results of participants with acute pain and following them up for three months, the~     investigators expect to find objective indicators for acute pain changing into chronic pain~     and give preventive analgesia for people with high risk of chronic pain.~   "
2625|NCT03022851|"~     This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with~     severe pulmonary hypertension (PH).~   "
2626|NCT03022838|"~     Sporadic and chronic dietary consumption of caffeine has substantial biological effects on~     the nervous system. The effects on migraine are at large not known. In this study we want to~     assess the effects of caffeine withdrawal on migraine.~   "
2627|NCT03022825|"~     This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus~     ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer~     (NMIBC). All patients treated in the study will receive via a urinary catheter in the~     bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (induction). Patients without~     disease progression at Months 3, 6, 9 and 12 are eligible for continued BCG+ALT-803~     treatment (maintenance). The study duration is 24 months.~   "
2720|NCT03019757|"~     The study is designed to characterize the clinical, neuropsychological, polysomnographic,~     and neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and~     Parkinsons' Disease.~   "
2628|NCT03022812|"~     Neck pain is fourth among the most common conditions worldwide associated with longer~     periods of living with disability. Annually, about 30 000 people in Sweden undergo a~     whiplash trauma (WAD), and half of those individuals will develop chronic problems with high~     costs for the individual and society. Evidence for chronic WAD treatment is scarce, although~     neck-specific training at a physiotherapy clinic (2 times a week for 3 months) has~     demonstrated good results. A more efficient, flexible rehabilitation with reduced waiting~     times and lower costs is needed, ideally replacing lengthy on-site treatment series by~     health care providers. Internet-based care has proven to be a viable alternative to personal~     care meetings for a variety of diseases and interventions, but studies are lacking on~     Internet-based interventions for individuals with chronic neck problems. The purpose of this~     study is to investigate if A) neck-specific training delivered through Internet-based care~     differs from B) a longer series of treatments at a physiotherapy clinic regarding, e.g.,~     work ability, sick-leave and disability. This prospective, randomized study involves 140~     participants. Measurement is done at baseline, 3 months (end of treatment), and 15 months~     (12 months after end of treatment in the study) and will include ratings of work ability,~     sick-leave, work presenteeism, disability, pain, health, satisfaction with care, quality of~     life, and cost-effectiveness. The study results may contribute to the development of a more~     effective rehabilitation, flexible and equal care, shorter waiting times, increased~     availability and lower costs for health care and society. The program can be implemented on~     a broader scale in neck pain patients.~   "
2629|NCT03022799|"~     This first in human, single-center, randomized, placebo-controlled, double blind, sequential~     group Phase 1 study in healthy subjects will be conducted to evaluate the safety,~     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) following the escalation of~     single and multiple doses of KM-819.~      The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects,~     and 1 single dose cohort of elderly male or post menopausal female subjects will receive~     escalating single doses of KM-819. The food effect will be investigated in one of the single~     dose cohorts of young adult male subjects, who will be crossed-over to the fed condition.~     Once the dose level is selected for the crossed-over to the fed condition and elderly~     subjects, the protocol will be amended to specify the dose level. In Part B, up to 4 cohorts~     of healthy young adult male subjects and 1 multiple dose cohort of elderly male or post~     menopausal female subjects will receive escalating multiple doses of KM-819. Part B will be~     conducted after completion of all cohorts of young adult male subjects in Part A.~      Dose escalation to the next level will be determined using safety, tolerability, and PK data~     of the previous cohort.~      Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy~     elderly male or post menopausal female subjects will be enrolled and randomized to receive~     either KM-819 or placebo.~      Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6~     subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive~     placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects~     will be dosed on the first day (1 subject will receive active treatment and 1 subject will~     receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the~     first 2 subjects.~      Cohorts will be dosed sequentially with escalating doses. One of the cohorts will be~     crossed-over to the fed condition to assess the effect of food as decided by Investigator~     and Sponsor during the study after completion of the 2nd dose cohort (30 mg).~      Eight elderly male or post-menopausal female subjects will be enrolled into an additional~     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested~     in the young adult male cohorts and 2 subjects will receive placebo.~      Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when~     subjects are hospitalized for study activities. Subjects are required to return for~     outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14. The cohort that~     crossed-over to the fed condition will undergo the same procedure up to the Outpatient Visit~     on Day 4. Subjects will be confined for 3 days for the second time, and are required to~     return for outpatient Visit 5 (Day 4), Visit 6 (Day 7), and for a Follow up Visit 7 (Day~     14).~      Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8~     healthy elderly male or post menopausal female subjects will be enrolled and randomized to~     receive either KM-819 or placebo.~      Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6~     subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2~     subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.~      Eight elderly male or post-menopausal female subjects will be enrolled into an additional~     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested~     in the young adult male cohorts and 2 subjects will receive placebo.~   "
2630|NCT03022786|"~     Explore the unmet needs of patients admitted to the hospital for severely inflamed skin of~     the lower legs, often described as 'bilateral cellulitis. These patients usually have~     intractable lower extremity edema, stasis dermatitis and sometimes allergic contact~     dermatitis rather than an infectious process; readmission is common. Investigators will~     create patient and provider education materials to align dermatological, home health, and~     other resources and measure reduction in hospital re-admission rate and length of stay.~   "
2631|NCT03022773|"~     The purpose of this study is to understand the role of nutrition and its effects on the eye~     and other tissues. The investigators propose to study this by validating and correlating~     various non-invasive measurement methods of carotenoid concentrations in the human eye and~     skin tissue.~      A secondary objective is to correlate blood levels of carotenoids on a sub-set of~     participants.~   "
2632|NCT03022760|"~     The aim of this project is to develop a model for return to work (RTW) for patients sick~     listed due to stress related mental disorders, which takes into account each patient's~     specific situation; includes the workplace, and is well adapted to the Swedish primary care~     setting.~      In late 2016, general practitioners and rehabilitation coordinators at both public and~     private primary care centers will be offered a one-day training about work and workability~     for patients with stress related mental disorders. Also, the participants will be trained in~     a specific method that includes the patient's employer early in the rehabilitation process~      The project has a quasi-experimental and longitudinal design. The intervention will be~     conducted on 15 different primary care centers, which will be matched with a comparison~     group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18~     months after sick-listing. The hypothesis is that patients who are sick-listed at primary~     care centers that completely or partially implemented the specific method on average will~     return earlier to work than patients sick-listed at primary care centers that did not~     implement the method.~      Alongside studying if the intervention has an effect on the patients' RTW over time, the~     investigators aim to investigate the mechanisms explaining the effects and the individual~     and organizational level (primary care units) circumstances necessary for these mechanisms~     to be triggered. To gain deeper knowledge about mechanisms and context, the investigators~     will conduct interviews with the treatment staff and collect registry data about the primary~     care units.~   "
2633|NCT03022747|"~     The study will investigate, in children with acute lymphoblastic leukemia during maintenance~     treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate~     therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The~     effect on hematological and liver toxicity parameters in blood will also be investigated as~     well as clinical toxicity.~   "
2634|NCT03022734|"~     The purpose of this study is the increase of resection rate of primary cancer in rectal~     after short course radiotherapy without interrupt chemotherapy schedule during the period of~     chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the~     progression of systemic metastasis, and to reduce the incidence of rectal carcinoma~     including metastasis.~   "
2635|NCT03022721|"~     The prospective observational study entitled Heidelberg Study on Diabetes and~     Complications is designed to Monitor the presence and development of diabetic complications~     in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new~     metabolic mechanisms or new risk factors for the development of diabetic complications in~     order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and~     comparison.~   "
2641|NCT03022643|"~     Behavioral and biological rhythms are essential for health. No study evaluated behavioral~     rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective~     of this study is to gather preliminary data, focusing on the role of behavioral rhythms in~     the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood).~     Additionally, this study will provide preliminary data for the feasibility and acceptability~     of the therapeutic approach aiming to strengthen behavioral rhythms for patients with~     chronic pain.~   "
2642|NCT03022630|"~     The purpose of this study is to evaluate, through a randomized controlled trial, the impact~     of integrated comprehensive palliative care services on time to first hospital readmission~     and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes.~     The intervention includes comprehensive, standardized palliative care services for adult~     hepatology patients for which prognosis is poor.~   "
2643|NCT03022617|"~     Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red~     itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the~     finger and toe nails. The most characteristic nail findings associated with nail psoriasis~     are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis~     causes a substantial disease burden for patients, it is critical that safe and effective~     treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is~     often difficult to treat.~      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4)~     that is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has~     shown promising results for treating psoriatic arthritis and nail disease; however more data~     is needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that~     apremilast will prove to be highly effective in treating nail psoriasis. We propose to~     conduct an open label clinical trial to investigate the efficacy and tolerability of~     apremilast in treating nail psoriasis, where we will follow the package insert guidelines~     for treating patients with apremilast.~   "
2644|NCT03022604|"~     This study is assessing the effects of a pre-workout dietary supplement.~   "
2645|NCT03022591|"~     This is a retrospective chart review. The purpose of this study will be to look at the~     outcomes of twin pregnancies diagnosed with short cervix along with the intervention~     (treatment) that these patients received.~   "
2646|NCT03022578|"~     Participant is being asked to take part in this study because they have glioblastoma or~     anaplastic astrocytoma (AA) that has relapsed (come back) after treatment and the study~     doctor thinks that it is in their best interest to receive chemotherapy for the disease.~     Additionally, the study doctor thinks it may be in participant's best interest to also have~     a surgical procedure called laser interstitial thermal therapy (LITT). LITT is a minimally~     invasive (using small incisions) surgery method that uses lasers to destroy tumor cells.~      For the procedure, the study doctor uses the NeuroBlate system to perform LITT in~     combination with MRIs and software models to focus the lasers on affected brain cells.~      The goal of this clinical research study is to learn if the NeuroBlate system in combination~     with lomustine can help to control glioblastoma or anaplastic astrocytoma (AA) that has~     returned after treatment. The safety of the combination will also be studied.~   "
2647|NCT03022565|"~     This proof-of-concept study will evaluate the ability of vorinostat to induce the~     transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal~     melanocytes.~   "
2648|NCT03022552|"~     This prospective observational cohort study, will investigate the platelet phenotype,~     platelet genetic composition, and role of platelets as effector cells in women with~     myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at~     NYU and Bellevue Medical Center, may have concurrent enrollment with the HARP Main Imaging~     (NCT02914483) and HARP Stress Ancillary Studies (NCT02270359). Additionally, a group of age~     and race matched disease controls 'CATH-NOCA' composed of women with stable angina referred~     for cardiac catheterization, will be enrolled. Blood obtained during the initial~     catheterization, 2 months post-MI, and following the stress study (for those participants~     enrolled in the stress study) will be utilized for platelet testing.~   "
2649|NCT03022539|"~     Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of~     pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates~     are high but may be associated with significant treatment-related toxicities, especially~     dermatologic, gastrointestinal, genitourinary and hematologic toxicity.~      Accurate treatment planning and dose delivery is essential for radiotherapy in order to be~     effective in terms of local tumour control and to reduce radiation-induced side effects.~     However, accuracy is challenged by tumour and organ motion from fraction to fraction~     (interfraction movements). At present, radiotherapy treatment planning is typically~     performed on one planning-CT scan which is performed before the start of the treatment.~     However, interfraction set up variations and organ motions can lead to differences between~     the calculated dose distribution on the planning-CT and the radiation dose actually received~     by the tumour and normal organs (actual given dose). Current photon radiotherapy of the~     pelvic area is relatively insensitive to these changes and margins from CTV to PTV ensures~     an adequate dose coverage of the tumour area. Despite newer techniques in photon therapy,~     like intensity modulated radiotherapy (IMRT), critical organs still receive a substantial~     amount of dose leading to clinically relevant acute and late side effects. With proton beam~     therapy, the amount of radiation dose to the organs at risk can be significantly reduced.~      For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more~     important. The major potential advantages of PBT for tumours in the pelvic area in terms of~     prevention of radiation-induced side effects are challenged by differences in bladder~     volume, rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup~     errors and organ motion cause geometric displacement of the tumours and normal tissues,~     which deteriorates the dose gradients from target volume to normal tissue. Furthermore, it~     can result in changes in tissue densities in the beam path, which can alter the position of~     the Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as~     significant local under and/or over dosage.~      In this study, the investigators want to evaluate the impact of inter and intrafractional~     tumour and organ motion on photon and proton radiotherapy treatment planning in order to~     create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with~     the final aim to lower treatment related toxicity.~      Objective: To explore the extent of inter- and intrafraction anatomical changes of the~     tumour and surrounding normal tissues, throughout the full course of treatment, and to~     subsequently assess the impact of these changes on the nominal planned dose. This~     information is required to design robust treatment plans (photon and/or proton) that will~     ensure optimal local tumour control while reducing toxicity.~      Study design: Pilot-study (40 patients).~      Study population: Patients with cervical, vulvar or anal cancer, who are planned for~     radiotherapy (with or without chemotherapy) with curative intent.~      Intervention (if applicable): Not applicable.~      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of~     clinical target volume), dose to organs at risk (OARs), such as the small bowel, rectum,~     bladder and bone marrow.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat~     planning CT scans without contrast agents in order to evaluate the impact of intra and~     inter-fraction tumour and organ motion.~      The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x~     22 mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The~     risks are therefore negligible and the burden is low.~   "
2650|NCT03022526|"~     The purpose of this pilot prospective randomized control trial is to compare the initiation~     of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on~     risk for postpartum depression symptoms. Investigators will randomize women to the receipt~     of CSE or E during labor, after measuring baseline psychological, psychosocial, and~     psychophysical factors related to pain and depression. The immediate research goals are to~     understand whether the association between labor pain and PPD is modifiable through the use~     of tailored anesthetic techniques.~   "
2651|NCT03022513|"~     Recently it has been reported that a consistent percentage of the general population~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have CD or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the~     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat~     causes the symptoms in NCGS patients, and the investigators also showed that these patients~     had a high frequency of coexistent multiple food hypersensitivity. The clinical picture of~     NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea~     and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis)~     and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy~     mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm~     numbness, and anemia). Nowadays no data are available on the characteristic of~     'rheumatologic' symptoms of NCWS patients. Therefore, the aims of the present study are: 1)~     to investigate the prevalence of fibromyalgia-like joint/muscle pain in NCWS patient, 2) to~     search for possible ultrasonographic alterations (i.e. synovitis) of hands and feet joints~     of NCWS patients, and 3) to evaluate modification of fibromyalgia-like joint/muscle pain in~     NCWS patients after a gluten free diet period of almost 6 months.~   "
2652|NCT03022500|"~     To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed~     pulmonary sarcomatoid carcinoma~   "
2896|NCT03019302|"~     A prospective study evaluating the timing, incidence and relationship of commonly occurring~     complications related to the use of peripherally-inserted central catheters. All subjects~     will receive PICC access using the Arrow PICC with Chloragard Technology.~   "
2653|NCT03022487|"~     This is a prospective open label single blinded multi-centre observational study involving a~     study group of patients already undergoing implantable cardioverter-defibrillator~     (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard~     30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the~     end of the ICD implant at baseline. This EP test will be performed whilst measuring a~     12-lead ECG and will be correlated with event rates to establish their effectiveness in~     predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of~     3 years, which is how long the study is funded for. This study is not randomised as all~     study patients will be receiving the EP study performed at baseline. A minimum of 440~     patients will be recruited to document event data at standard clinical ICD follow up~     intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab~     were the ECG analysis will be performed by a nominated researcher who will not have details~     of patient health status.~   "
2654|NCT03022474|"~     This study was designed as a non-randomized controlled trial to examine the effectiveness of~     a kindergarten-based intervention for childhood obesity among young children (3-6 years old)~     and provide decision-makers with scientific evidence for policy planning and resource~     allocation.~   "
2655|NCT03022461|"~     The purpose of this clinical investigation is to report the long term survival and incidence~     of adverse events in the patients who were implanted with HM3 in the CE Mark Study and~     continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.~      The study will be a single arm, prospective, multi-center, non-blinded and non-randomized~     study, intended to report on the long term use of the HeartMate 3 LVAS in those patients~     that completed the 2-year follow-up in the HeartMate 3 CE Mark study.~   "
2656|NCT03022448|"~     The aim of the non-interventional study is to prospectively collect and analyze data on the~     geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with~     focus on patients who have been assessed by the treating physician as being unsuited to~     receive standard chemotherapy with anthracyclines and / or ifosfamide.~      Trabectedin will be used according to the local SmPC. Modification of the treatment schedule~     should follow the standard medical practice at the discretion of the treating physician and~     is not part of this Observational Plan.~   "
2657|NCT03022435|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
2658|NCT03022422|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
2659|NCT03022409|"~     This biomarker window basket study has been designed with the intent of assessing the~     effects of different agents in both tumour tissue and peripheral samples to further inform~     optimal combinations of DDR agents with immuno-oncology (IO) therapies and the suitable~     sequencing and relative timing of these therapies.~      In the first instance 2 DDR agents will be assessed as monotherapy. Based on emerging data~     additional arms may be incorporated to evaluate other DDR agents and/or DDR and~     immunotherapy agents in combination or in series.~      The primary objective of the study is to investigate immune activation due to DDR inhibition~     by monitoring the induction of TH1/IFNg response in tumours of patients treated with study~     investigational agent(s)~   "
2660|NCT03022396|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
2661|NCT03022383|"~     To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus~   "
2662|NCT03022370|"~     This study evaluates whether the behavioural/structural interventions of Stepping Stones and~     Creating Futures can reduce the incidence of intimate partner violence in urban informal~     settlements amongst young people. Half the participants will receive the interventions,~     while the other half will be in a control wait-list, only receiving the intervention after~     final data collection.~   "
2663|NCT03022357|"~     Prospective observational study to compare sensitivity of 3T functional Magnetic Resonance~     Imaging (3T fMRI) at diagnosing Parkinson's Disease (PD) against the benchmark DaTScan~     diagnostic test and clinical diagnosis at follow up.~   "
2664|NCT03022344|"~     However, there is only very sparse information regarding the atherosclerotic burden and~     cardiovascular biomarkers in the early stages of type-2 diabetes, as the vast majority of~     studies have concerned diabetes populations with more than 5 years average diabetes age or~     high-risk subgroups, who at inclusion already had atherosclerotic disease manifestations.~      Consequently, this study aims on evaluating the occurrence of early-stage subclinical~     atherosclerosis in newly diagnosed type-2 diabetes with special emphasis on coronary plaque~     characteristics by modern imaging techniques. These findings will be compared to the~     functional status of various peripheral arterial segments and biomarkers in the~     cross-sectional part of this study. The 5-year follow-up study intends to describe~     relationships between these selected measures for general atherosclerotic involvement and~     the progression of the coronary atherosclerotic burden by contemporary techniques.~   "
2665|NCT03022331|"~     The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a~     variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA),~     Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others.~     This study will establish a longitudinal cohort for these diseases.~   "
2666|NCT03022318|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in~     patients with Neovascular AMD, and measure the effects on visual acuity and retinal~     abnormalities due to wet (neovascular) AMD.~   "
2667|NCT03022305|"~     The investigators hypothesize that neuromuscular realignment of the pelvis bones will be~     more effective in improving range of motion and torque production at the shoulder joint than~     traditional exercises for improving hip internal rotation and adduction range of motion.~   "
2668|NCT03022292|"~     A study investigating the ability of OCTA imaging technology to identify and analyze~     untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with~     exudative macular degeneration, as well as investigating the ability of the OCTA imaging~     technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in~     neovascular lesions associated with macular degeneration.~      This study is utilizing a new, FDA approved, non-standard of care technology~     (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard~     of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed~     with neovascular AMD who are naive to previous Anti-VEGF therapies.~   "
2669|NCT03022279|"~     The objective of this study is to compare transversus abdominis plane (TAP) blocks to local~     wound infiltration (LWI) in terms of postoperative pain control in pediatric patients~     undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be~     superior to LWI for postoperative pain control resulting in decreased use of opioid /~     narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative~     period. The rationale is that determining the effect of analgesia in this pediatric~     population is important to optimize clinical care.~   "
2670|NCT03022266|"~     The proposed study is a pilot randomized clinical trial (RCT). Participants in the~     intervention arm will participate in a 90-day adherence promotion program based on the~     theory of behavioral economics and administered through the Wellth mobile phone application.~     Subjects will be provided a CleverCap® Lite BLE C035 smart pill bottle (electronic~     monitoring (EM), device) containing a 90-day supply of aspirin (90 pills) and those in the~     intervention arm will be offered $150 for app-based medication check-ins, which consist of~     uploading daily photos of pills at the time of administration through the Wellth app.~     Subjects will have $2 deducted from total rewards for each day that a medication check-in is~     missed. Subjects in the control arm will receive usual care and be monitored with the same~     EM device types used in the intervention arm.~   "
2671|NCT03022253|"~     Patent ductus arteriosus (PDA) is a common problem in preterm babies. Recently there have~     been various studies for and against an association between thrombocytopenia and PDA. A~     meta-analysis published in 2015 showed a marginally significant positive association between~     PDA and thrombocytopenia but these were all observational studies and there are no~     randomized controlled trials (RCT) on it. The investigators decided to conduct an RCT to~     determine whether liberal platelet transfusion criteria achieve earlier PDA closure rates~     than standard restrictive platelet transfusion criteria among thrombocytopenic preterm~     neonates (<35 weeks' gestation) with hemodynamically significant PDA presenting within the~     first 14 days of life. The investigators primary objective is to determine whether liberal~     platelet transfusion criteria achieve earlier PDA closure rates within 120 hours compared to~     standard restrictive platelet transfusion criteria among thrombocytopenic preterm neonates~     (<35 weeks' gestation) with hemodynamically significant PDA presenting within the first 14~     days of life.~      The investigators will stratify the study population based on platelet count, i.e < 50000~     and 50000-100000 per microlitre, and will randomly allocate participants to control and~     intervention group. Babies in the intervention group will receive platelet transfusion to~     maintain the platelet count above 100,000 per microlitre. Babies in control group will~     receive platelets only when clinically indicated and as per current standard indications.~     The investigators will perform an echocardiogram at baseline to document a hemodynamically~     significant PDA (hsPDA) and then serially to look for the closure of PDA. Medical management~     of PDA will be as per unit policy. The investigators will follow the baby till PDA closes or~     120 hours post randomization.~   "
2672|NCT03022240|"~     The demand for magnetic resonance imaging (MRI) in pediatric patients is increasing due to~     its use in medical diagnosis and surveillance. Pediatric patients often require general~     anesthesia (GA) for MRI due to the need for prolonged immobility during the scanning process~     to obtain high quality images. Two widely used anesthetic techniques for pediatric MRIs are~     volatile-based anesthesia using sevoflurane and total intravenous anesthesia (TIVA) using~     propofol. Concerns have been raised regarding the potential neurotoxic effects of~     anesthetics on the developing brain. Within the animal literature, there is emerging~     evidence to suggest that both sevoflurane and propofol may cause inflammation, impacting~     brain cell survival and connections, thereby contributing to possible cognitive dysfunction.~     However, given the challenges in extrapolating the animal data to humans, and the relatively~     limited human cohort studies examining the long-term effects of anesthesia exposure, there~     is inadequate information available to make informed clinical decisions regarding the choice~     of optimal anesthetic agents for MRI in children. Therefore, this study will uniquely~     examine the mechanisms of two widely used anesthetics and their short and long-term impact~     on developmental outcomes in healthy children.~   "
2673|NCT03022227|"~     Cochlear implants (CIs) are medical devices now widely used in persons with severe to~     profound hearing loss. After a six month to one-year period following implantation, adults~     typically reach optimal fitting parameters, which lead to a stabilized hearing performance~     with their CI. At this stage, they usually enter a routine clinical after-care program,~     which involves regular appointmentsattheir CI center. Such visits aim at identifying any~     complication, which can be medical (abnormal cutaneous healing evolution) and/or device~     related, as well as any declinein performance (possibly related to the former). In France,~     the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year~     during the second and third years after implantation, and then annually. While the schedule~     of appointments remains dependent on centers' practices, there is some kind of consensus~     about the minimal content of a long-term follow-up session:medical consultation, CI external~     parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech~     understanding assessments.~      Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS,~     providing after-care for no less than 750 CI users, most of whomhave entered their long-term~     follow-up period. For some, attending follow-up appointments may need several hours, require~     taking a half-day off work, and entail travel expenses. Some patients may also have~     associated disabilities making it difficultto reach the center.Moreover, although the cohort~     of patients has increased over the years, the number of trained professionals and the~     clinical care infrastructures have not evolved proportionally. As a consequence, there is a~     need to reduce the number of routine visits, to allow more scope for complex cases andto~     efficiently identify issues.~      Remote consultation seems to address all the points listed above. However, it appears that~     little has been doneto develop remote after-care for cochlear implant recipients. Published~     studies mainly focus on the fitting aspects.~      The development of telemedicine has become one of the key priorities of the French~     government over the past few years, and it is now feasible thanks to the development of high~     speed connections (ADSL, mobile internet, high definition transmissions). Promoting~     telemedicine has several goals, the main one being to extend health care services to~     underserved patients in remote locations; it also allows some medical units to be freed~     upand to reserve infrastructures and professionals for patients requesting critical care. Of~     course, telemedicine is also meant to save costs.~      The objectif of this protocole is to evaluate the feasibility of telemedicine applied to~     adult cochlear implant users' follow-up by comparing the data of the medical consultation~     and speech therapy assessment, carried out in the CRIC service and videoconferencing when~     the patient is home, using his computer equipment to communicate with the CRIC.~   "
2674|NCT03022214|"~     Since 1948, health has been defined as a state of complete physical, mental and social~     well-being, and not merely the absence of disease and infirmity . However, a growing school~     of thought suggests that health represents an ability to be adaptable and flexible in~     response to daily stressors. It has been proposed that instead, the view of health should be~     towards the ability to adapt and self-manage in the face of social, physical and emotional~     challenges, which has been termed resilience.~      The theory of resilience relates health to the body's capacity to manage daily stressors~     (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the~     return to homeostasis resulting from several physiological stress responses. Although this~     is an all-encompassing model, and the effects of pathogens and other stress factors are also~     relevant, this study will centre on the physiological aspects on this theory, focussing on~     the disruption through exercise.~   "
2675|NCT03022201|"~     This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in~     patients with Parkinson's disease~   "
2721|NCT03019744|"~     Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled~     Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in~     post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care~     rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation~     to assist normal arm movements during rehabilitation of the upper limb in persons with~     stroke will improve the movement quality and success and thus induce recovery at the body~     functions level (impairment) and the activity level (disability) of the International~     Classification of Function (ICF) superior to that induced by usual care rehabilitation.~   "
2676|NCT03022188|"~     Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic~     incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or~     not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large~     tumor (> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of~     malignancy, or in presence of metastasis, is well admitted: surgery is indicated or should~     be discussed. However, the attitude is less consensual for small (≤ 2 cm) non-functioning~     (NF) and non-metastatic lesions. In English, American or French recommendations, systematic~     surgical resection with lymphadenectomy is currently recommended in all medically fit~     patients. The follow-up (FU) is possible for tumors <2 cm (T1) located in the pancreatic~     head and for which enucleation is not feasible. Several recently published retrospective~     studies discuss the non- surgical management of the small NF incidentally detected~     pancreatic NETs (IPNETs) and highlight the necessity of developing guidelines for management~     of these patients. A strict correlation between tumor size and malignancy of these tumors~     was demonstrated in the single-center retrospective Italian study of Bettini and col., which~     included all patients with NF PNETs who underwent curative (R0) resection during 18 years.~     In the group of 51 patients with small size of T (2 cm or less), incidentally discovered,~     the majority of lesion was benign, and the authors concluded that follow-up can be proposed~     in patients with incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size~     and asymptomatic character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was~     estimated to be 24 % (in 18% and 6% of cases, uncertain behaviour and carcinoma were~     present). Given the inherent morbidities associated with pancreatic surgery, a risk-benefit~     calculation may favour surveillance rather than surgery in highly selected patients. Thus, a~     better understanding of NF IPNETs and identification of their prognostic factors can be of~     help to select a subgroup of patients who could benefit from a long-term surveillance rather~     than a systematic surgical resection. Clearly, large prospective trials are needed to~     validate this approach.~   "
2677|NCT03022175|"~     The purpose of this study is to assess the safety and tolerability of single and multiple~     intravenous doses of SPR741 when administered to healthy adult volunteers.~   "
2678|NCT03022162|"~     Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer~     agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced~     peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel~     induced peripheral neuropathy most commonly presents as~        1. Pain~        2. Burning,~        3. Tingling (pins and needles feeling) or electric/shock-like pain,~        4. Hyperalgesia,~        5. Allodynia,~        6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically~          in the distal extremities (glove and stocking distribution).~      Most adverse effects associated with chemotherapy are ameliorated after cessation of the~     therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related~     symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of~     neuropathic pain in breast cancer patients has high clinical and public health significance.~   "
2679|NCT03022149|"~     The purpose of this study is to determine whether the remote ischemic preconditioning are~     effective in the treatment of mild to moderate vascular dementia.~   "
2680|NCT03022136|"~     Significant differences exist among various dermatome maps. In addition, there were no~     anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the~     sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate~     sensory innervations by epidural block. Patients undergoing urological surgery will receive~     epidural block. Fifty patients with superior border of complete sensory loss to ice from T9~     to T12 (anterior median line) will be included in this study. The sensory loss to ice will~     be evaluated at midclavicular line, anterior axillary line, posterior axillary line,~     scapular line and posterior median line. The level of vertebrae will be identified and~     marked by ultrasound. The superior border of complete sensory loss to ice from anterior~     median line to posterior median line will be recorded for every patient. The dermatome map~     of T9 to T12 will be drawn. The landmarks of sensory innervations at posterior median line~     will be established using vertebrae.~   "
2681|NCT03022123|"~     270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma~     (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed~     CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in~     combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab~     (according to CHOP-R regimen) every 21 days for six courses.~   "
2682|NCT03022110|"~     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and~     traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the~     cyst recurrence rate of 12 months after treatment.~   "
2683|NCT03022097|"~     This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and~     multinational Phase III study to determine the efficacy and safety of Aclidinium~     bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium~     bromide compared with Placebo when administered to patients with stable Chronic Obstructive~     Pulmonary Disease (COPD).~   "
2684|NCT03022084|"~     The purpose of this study is to determine if a novel sound-based therapy in comparison to~     standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects~     for people with bothersome tinnitus.~   "
2685|NCT03022071|"~     Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated~     with significant disability, mortality and economic burden. MDD is ranked fourth in terms of~     disease burden as defined by the World Health Organization (2001). Cognitive Behavioral~     Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for~     patients with depression. However, many patients do not respond sufficiently to treatment~     and relapse rates are high. To be able to offer individualized treatment, a clinically~     important question is therefore whether some patients profit more from one of the two~     therapies. At present little is known on which patient characteristics (moderators) may be~     associated with differential outcomes of CBT and PDT and through what kind of therapeutic~     processes and mechanisms (mediators) improvements occur in each therapy mode. There are~     actually only theoretical assumptions sparsely supported by research findings on what~     moderates and mediates the treatment effects of CBT and PDT.~      Aims: The overall aim of this project is to examine putative moderators and mediators in CBT~     and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for~     patients with MDD.~      Methods and study design: The study is a randomized clinical trial. One hundred patients~     will be randomized to one of two treatment conditions. The patients will be treated over 28~     weeks with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly)~     during the rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The~     patients will be evaluated at baseline, during therapy, at the end of therapy, and at~     follow-up investigations 1 and 3 years after treatment termination. The outcome measures~     comprise a large range of clinical and process variables, including assessment tools~     measuring specific preselected putative moderators and mediators.~      Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of~     treatment should be offered the individual patient. Moreover, it will shed light on what~     kind of mechanisms in psychotherapy that is followed by symptom improvement and increased~     psychosocial functioning.~   "
2731|NCT03021655|"~     This study is a 3-arm randomized controlled trial including: (1) Adventure-based training~     intervention group, (2) WhatsApp intervention group and (3) Control group.~   "
2897|NCT03019289|"~     The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R~     (optional) in the living human brain. No formal statistical analysis will be conducted~   "
2686|NCT03022058|"~     The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording~     EEG in which the signal is recorded using dry-contact electrodes embedded on a customised~     ear piece. One intended medical indication of the EarEEG system is the detection of~     hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no~     studies exist investigating the detection of hypoglycaemic episodes by use of ear~     electrodes. While a finger prick test accurately measures the blood glucose level, it does~     not provide continuous measurements, and hence it is unreliable as a hypoglycaemia alarm.~     Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces~     the risk of severe hypoglycaemia. However, some find these devices troublesome to use and~     utilisation of CGM has remained limited to date. Observational data show that only a small~     percentage of patients with type 1 diabetes are using CGM on an ongoing basis. Thus, there~     is a medical need for a reliable hypoglycaemia detection device which is easy and convenient~     to use.~      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced~     changes in the EEG by use of the EarEEG system.~   "
2687|NCT03022045|"~     The purpose of this study are to investigate the safety and efficacy of two different dose~     regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or~     erythrodermic psoriasis (EP).~   "
2688|NCT03022032|"~     This research study is evaluating a new smartphone application named the Helping Our~     Patients Excel (HOPE) app with Fitbit devices. The HOPE app was designed to learn about~     improving quality of life~   "
2689|NCT03022019|"~     Rationale:~      Autologous epidermal cell suspension grafting is an effective method of surgical treatment~     in vitiligo, which is suitable for treating large areas with good cosmetic results.1 The~     RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK)~     (previous name: ReCell) is a device which, compared to other forms of autologous epidermal~     cell suspension grafting, is easier in use showing similar results.2 Efficacy and safety of~     the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in~     non-segmental vitiligo is not yet confirmed in randomized controlled trials. We hypothesize~     that grafting using the ReNovaCell device in combination with standard of care is also~     effective in stable non-segmental vitiligo and more effective than standard of care alone.~      Objective:~      Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB~     therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental~     vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and~     persistence of repigmentation after ReNovaCell transplantation.~      Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.~      Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving~     standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6~     months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical~     Centre, University of Amsterdam.~      Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical~     anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive~     ReNovaCell grafting or no grafting. Standard of care will be given according to the standard~     treatment protocol of our institute.~      Main study parameters/endpoints:~      Primary outcome:~      Objective assessment of the degree of repigmentation three and six months after ReNovaCell~     grafting with a digital image analysis system. To assess the pigmentation, the contours of~     pigmentation are copied on a transparent sheet before, three and six months after treatment,~     after which the sheets are scanned and digital image analysis is used to compute the~     affected surface. By comparing pre- and post-treatment pictures, the relative surface~     showing repigmentation expressed as percentage of the selected treated patch is computed.~      Secondary outcomes:~        -  Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability~        -  General patient assessed outcome per treatment region on a scale from 0-3 (poor,~          moderate, good or excellent).~        -  Visual assessment of percentage repigmentation by blinded observer and color match to~          normal skin~        -  Visual assessment of side effects per treatment region (hyperpigmentation,~          hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.~        -  A small amount of the suspension of the included patients and the redundant lesional~          punchgrafts of all patients will be used for flow cytometric analyses of the cellular~          composition of the grafted cell suspension, and expression analysis of melanin~          synthesis-related genes. These data will be correlated to the clinical data.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: As the study involves large depigmented lesions, which are too large to treat~     in regular surgical treatment (punch grafting), patients will not miss any regular~     treatment. The time investment for the patient will be approximately 20 minutes for the~     punchgrafting session, 75 minutes for the cell suspension grafting session and 15 minutes~     for the three follow-up visits. Two of the five visits are part of the standard of care UVB~     follow-up regimen and are therefore not additional due to the study. Infection in the~     grafted area or the donor site may occur but is very rare; the risk of mild textural changes~     in the donor site is moderate. Hyperpigmentation of the treated area does occur often,~     although this improves over time in most cases. In case of improvement of the~     depigmentation, patients may receive another treatment for the (contralateral) untreated~     side.~   "
2690|NCT03022006|"~     The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million~     and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is~     high in hemodialysis patients, and it has been revealed that the prognosis is poorer in~     HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive~     therapeutic intervention is required.Investigator previously reported the efficacy and~     safety of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir~     combination therapy for Japanese dialysis patients with genotype 1 HCV infection. However,~     the duration of the treatment is 24 week, which is quite longer than current standard 12~     week therapy .~      elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of~     IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies~     . Of note is that these drugs are metabolized mainly in the liver and thus they can be used~     in patients with chronic renal failure. Recently, David Roth et al reported that the~     efficacy and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis~     C virus genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they~     revealed that elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the~     modified full analysis set.~      However, no adequate clinical investigation has been performed in Japan, thus far concerning~     the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese~     hemodialysis patients.~   "
2691|NCT03021993|"~     The purpose of this study is to look at the effectiveness of nivolumab in patients with oral~     cavity cancer (OCC) who are about to undergo surgery.~   "
2692|NCT03021980|"~     This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle~     intervention for preschool children. It will consist of both an preschool component and a~     family component and is aimed at increasing healthy nutrition and physical activity. Half of~     the participating preschools will implement SuperFIT, while the other half of the preschools~     will continue as usual.~   "
2693|NCT03021967|"~     Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced~     with ever more complex situations, particularly in the case of severe, progressive, and~     incurable pathologies.~      Thanks to their willingness and expertise, these care providers try to guarantee the~     continuity and quality of care for both patients and patients in a palliative situation.~     Nevertheless, these same actors testify to the complexity they encounter in the care of~     patients in advanced or terminal stages, especially since the concept of palliative care,~     which was often erroneously reduced during the Any end of life and therefore death, remains~     a source of questions, contradictions, even resistances.~      In this context, how do physicians and caregivers appropriate palliative care? How do they~     react to the complexity and intensity of certain situations? Do they have specific~     expectations of help or support in the face of certain difficulties? Are there actions to be~     carried out and developed to make the aid given to these actors of the palliative approach~     more efficient?~      These are the topics that the HUS palliative care service proposes to explore through a~     study of physicians and caregivers working in HUS services for adult patients with LISP.~   "
2694|NCT03021954|"~     This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of~     pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical~     trial compares the pelvic floor muscle repair in primipara following labor between the~     interventional group who received intramuscular PRP injection in levator ani muscle and the~     control group, as assessed by ultrasonography, perineometry, and biomarker assessments.~   "
2695|NCT03021941|"~     In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT)~     for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease. The recommended~     dosage for treatment-naïve adult and pediatric subjects 4 years of age and older is 60 units~     per kg of body weight administered every other week as a 60 to 120 minute intravenous~     infusion. As a postmarketing commitment, the Sponsor agreed to evaluate the pharmacokinetics~     (PK), pharmacodynamics (PD), and safety of Elelyso (taliglucerase alfa) in pediatric~     subjects with Type 1 Gaucher Disease. in at least 5 subjects with body weight less than 15~     kg; at least 5 subjects with body weight 15 to less than 20 kg; and at least 5 subjects with~     body weight of 20-25 kg with Type 1 Gaucher disease dosed at 60 units/kg every other week.~      When applicable, PD measurements for children enrolled in the PK study may be obtained~     through the taliglucerase alfa registry (PMR 1895-5) and will include organ volumes (spleen~     and liver), hematological values (hemoglobin and platelets) as well as growth (height and~     weight) data. Safety data, including any serious hypersensitivity reactions, such as~     anaphylaxis, as well as changes in antibody status (ie, detection and titers of binding and~     neutralizing antibodies, and detection of IgE antibodies), will also be collected through~     the taliglucerase alfa registry.~   "
2898|NCT03019276|"~     To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
2696|NCT03021928|"~     Title:~      Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation~     (START): a pragmatic, adaptive randomized clinical trial.~      Primary Objective:~      • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral~     Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial~     fibrillation.~      Secondary Objectives:~        -  To compare the rates of primary adverse outcomes in a per protocol analysis~        -  To compare 30 day clinical outcomes by the modified Rankin scale among the~          time-to-treatment groups~        -  To compare 90 day clinical outcomes by the modified Rankin scale among the~          time-to-treatment groups~        -  To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC~          choice~   "
2697|NCT03021915|"~     This is a single center, prospective, controlled pilot safety research study. The primary~     objective of this research study is to assess the safety with the use of the OvaPrime~     procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor~     ovarian response (POR).~      A maximum of fifty (50) subjects will be enrolled to achieve the target sample size of 40~     Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject~     shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to~     the EggPC vehicle as a means to have each subject serve as their own control. Results~     between the treatment and control ovary will be examined for relevant endpoints such as~     antral follicle counts.~      The duration of the research study is estimated at approximately 6 years total, for the~     period spanning enrollment (estimated at approximately six months), eight months to the last~     hyperstimulation and through completion of 5-year follow-up (main study protocol with one~     year primary endpoint and LTFU sub-study which extends to 5 additional years).~   "
2698|NCT03021902|"~     This study proposes a novel early intervention combining Intravenous (IV) amino acids plus~     in-bed cycle ergometry exercise to improve physical outcomes in critically ill patients. We~     hypothesize that this innovative approach will improve short-term physical functioning~     outcomes (primary outcome), as well as amino acid metabolism, body composition, and~     patient-reported outcomes at 6-month follow-up.~   "
2699|NCT03021889|"~     Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and~     bodily changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia~     latter being associated with a higher chance of cardiovascular events and death.~      Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living~     with HIV / AIDS in antiretroviral therapy.~      Method: This is a randomized clinical trial with young people 13-19 years in outpatient~     treatment in a general hospital to present dyslipidemia. The intervention group received~     nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The~     control group received standard care consisting of medical care. Demographic, clinical,~     nutritional variables, food surveys and lipid profiles were collected at baseline and at the~     end of the study for both groups.~   "
2700|NCT03021876|"~     L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of~     carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third~     those in corresponding tissues of eight normally nourished non-hepatic patients who died~     after an acute illness of a 1-3-day duration. In the recent years, it has been reported that~     sirtuin 3 (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing~     SIRT3 to improve mitochondrial dynamics has potential as a strategy for improving outcomes~     of renal injury. In the current study, it is the first clinical interventional research~     whether L-carnitine corrects ammonia metabolism associated with liver injury in~     hepatectomized patients.~   "
2701|NCT03021863|"~     Questionnaires are frequently used in online research, however recruiting, and completion~     rates of online participants from a variety of cultures and demographic backgrounds can be~     challenging. The challenge is greater in an online cohort because there is no way to observe~     the participant beyond what is contributed online. Poor recruiting and completion can result~     in underpowered research that may not be representative of the sample population. This can~     trigger an increase in costs as the recruitment period may have to be extended until sample~     size is reached. When recruiting and completion rates are inadequate studies may have to be~     terminated and the answer to the research question can remain unknown.~      To mitigate these challenges, reminder emails are sent to questionnaire respondents. There~     is uncertainty about how the tone of the email reminder affects the proportion of~     recruitment rates.~      A nested randomized trial will be used to test the intervention of tone delivery in survey~     email reminders to establish an evidence base. This study (ResponseQT) proposes to link with~     the anticipated 20,000 person international cohort study, (How Frequently and in What Format~     are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT)~     to explore the evidence of effect for the research question, Does the tone of a survey~     email reminder affect the proportion of survey participants recruited. The population will~     consist of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The~     intervention is the tone of questionnaire email reminders and the outcomes will be the~     proportion of participants recruited after invitation (partial plus complete responses)~     following reminder 1 and 2.~   "
2702|NCT03021850|"~     The purpose of this study is to compare the acute effect of the use of different thermal~     modalities associated to the training of passive flexibility of the hamstring muscles in the~     amplitude of motion of the knee extension.~   "
2703|NCT03021837|"~     This study will look at blood sugar levels in pregnant women who have been given a~     glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help~     determine the likelihood, predictive value, adverse effects, response of patients diagnosed~     with gestational diabetes and time course of blood sugar elevation following steroids.~   "
2704|NCT03021824|"~     An assessment of early management of moderate-severe ARDS in the United States, including~     ventilator management and use of rescue therapy.~   "
2705|NCT03021811|"~     Multi-center, prospective, interventional, uncontrolled open-label study evaluating the~     real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg~     ulcers, diabetic foot ulcers, pressure ulcers).~   "
2850|NCT03020251|"~     This randomized controlled trial will evaluate the effect of a preoperative rehabilitation~     program at home in patients resected for lung cancer, comparing a control group (C group)~     receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a~     training program at home and chest physiotherapy~   "
2706|NCT03021798|"~     The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no~     therapeutic intervention that will be conducted in three European countries, (Belgium,~     France and Italy), and in the US.~      300 community dwelling older adults (men or women≥65 years) reporting loss of physical~     function and at risk of mobility disability, will undergo mobility functional evaluation and~     Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at~     six-month interval.~      Participants aged ≥ 65 years complaining of poor physical function will be selected to~     perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will~     be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI <~     0.789 in men and 0.512 in women will be included. The investigational phase will comprise~     two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance~     test and the 400-metre walking test will be administered at the main visits. Patient~     Reported Outcomes (PROs) will be completed by the patients at the same visits.~   "
2707|NCT03021785|"~     This is a multicenter, open-label study to evaluate the safety, pharmacokinetics,~     immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in~     patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks).~   "
2708|NCT03021772|"~     Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is~     simple, safe, reliable, less cost, efficient method in forearm surgery. The advantage of~     this method has fast return of motor and sensory function which enables patients for earlier~     discharge. However, this method has disadvantages such as tourniquet pain, insufficient~     muscle relaxation and postoperative analgesia.~      Lidocaine inhibits action potential propagation within neuronal tissue by binding to~     receptors in Na+ channels located on the nerve cell membrane. Lidocaine IVRA is safe and~     effective and is associated with a rapid onset (4.5 minutes) of anesthesia after injection~     and termination of analgesia (5.8 ± 0.5 minutes) once the tourniquet is deflated.~      Neostigmine is a typical cholinesterase inhibitor. It increases the level of acetylcholine~     (Ach) and indirectly stimulates both nicotinic and muscarinic receptors. In anesthesia,~     neostigmine is a drug that has been used for reversal of residual neuromuscular block.~     Administration of neostigmine by intrathecal and epidural routes has been found to cause~     analgesia by inhibition of the breakdown of Ach in the spinal cord.~      Dexamethasone is commonly used in anesthesia to prevent postoperative nausea and vomiting~     (PONV). Two recent meta-analyses have documented that dexamethasone also reduced~     postoperative pain and opioid requirement. Intravenous dexamethasone has also been shown to~     improve postoperative pain control in patients receiving spinal or epidural morphine.~      Hong et al reported that intravenous dexamethasone in combination with a caudal block with~     ropivacaine prolonged the duration of postoperative analgesia without adverse effects in~     children undergoing orchidopexy. So the investigators expect that addition of dexamethasone~     or neostigmine will affect duration and postoperative analgesia in bier block.~   "
2709|NCT03021759|"~     In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled~     trial to evaluate an active choice intervention with and without social comparison feedback~     to increase physician statin prescribing rates for eligible patients.~   "
2710|NCT03021746|"~     To understand the effectiveness of three approaches to address diabetes self-management~     support compared to enhanced usual care in church-based settings.~   "
2711|NCT03021733|"~     This project will involve planning and implementing a two-arm prospective pragmatic cohort~     clinical trial in patients with known rotator cuff tears.~   "
2712|NCT03021720|"~     Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of~     life with femoral versus radial arterial access~   "
2713|NCT03019848|"~     The purpose of this study is to determine if the oral supplementation with curcumin reduces~     proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney~     disease associated to Diabetes mellitus.~   "
2714|NCT03019835|"~     The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the~     antagonism of other drugs used in anesthesia, is a major challenge for the speciality.~      Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and~     antagonization of curares at the end of the procedure is associated with a reduction in~     mortality .~      Its use should be as large as possible and its contraindications are extremely rare.~      The antagonism of the NMBA reduces the duration of the neuromuscular block and the~     complications that are associated .~      In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and~     neostigmine as an antagonist.~      Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By~     reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in~     the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular~     blocking agents, and reverses the neuromuscular blockade.~      But the use of neostigmine in current practice is not very widespread in this clinical~     situation.~      The reduction in the duration of the block is significant in comparison with a spontaneous~     recovery .~      Moreover, spontaneous recovery is not always complete and sometimes very long.~      Nevertheless, its action is effective and this study could support this use but also specify~     the duration and the quality of the return to normal of the neuromuscular transmission.~   "
2715|NCT03019822|"~     The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor~     stimulation on empathy, mood perception, and amygdala activity to fearful stimuli. In~     addition, we predict associations between subjective effects/alterations in emotion~     processing tests and functional imaging (fMRI) activity.~   "
2716|NCT03019809|"~     Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF~     as additional agents for prevention of graft failure after transplantation with TCR~     alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.~   "
2717|NCT03019796|"~     To analyze the effects of different exercise training modalities (continuous, intervallic,~     and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome~     patients when this training interacts with their habitual medication.~   "
2718|NCT03019783|"~     The investigators hypothesize that older subjects with HIV randomly assigned to atazanavir~     will have increased bilirubin levels, reduced oxidative stress, and improved flow-mediated,~     endothelium-dependent vasodilation compared to subjects not switched to atazanavir.~   "
2719|NCT03019770|"~     The purpose of this study is to test a clinical Decision Aid that will help patients and~     providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision~     Aid will be tested in both clinical and non-clinical settings with 80 patient-provider~     dyads. The investigators hypothesize that the use of the Decision Aid will reduce patient~     decisional conflict. The investigators predict that it will increase patient and provider~     knowledge of and intent to initiate PrEP.~   "
20223|NCT02792491|"~     This is Phase II prospective trial of addition of rituximab to reduced dose CHOP~     chemotherapy in DLBC L patients aged 65 years and over.~   "
2722|NCT03019731|"~     This research is being done to determine whether a home-based behavioral therapy can be~     successfully used to treat tics in children with Tourette syndrome (TS). Behavioral therapy~     administered by a trained therapist has been shown to be helpful in reducing tics in~     children with Tourette syndrome. In this study, the investigators want to determine whether~     an instructional video can provide parents of children with TS with the tools necessary to~     successfully use behavioral therapy at home. The investigators also want to determine the~     effectiveness of home-based behavioral therapy as compared to improvement achieved when the~     therapy is provided by a trained therapist.~   "
2723|NCT03019718|"~     The purpose of this study is to implement the internet-based aftercare program 'GSA-Online~     plus' in several rehabilitation clinics with patients of different indications~     (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an~     internet-based aftercare program for patients with work-related problems or anxieties facing~     return to work after longterm sickness absence and inpatient rehabilitation. The patients~     have access to various exploratory and motivational videos on the study website until their~     inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based~     on a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme~     Method (CCRT)'. Patients write weekly online diary entries which are answered by anonymous~     online therapists usually within 24 hours. In a previous randomised controlled trial the~     efficacy of the intervention was determined, whereas the current study focuses on the~     implementation and realization in a naturalistic setting (effectiveness).~   "
2724|NCT03019705|"~     The purpose of the current explorative study is to examine the effects of health-related~     internet use in individuals with pathological health anxiety using ambulatory assessment. In~     a naturalistic setting participants answer over a seven-day period questionnaires about~     their health-related internet use and its effects on affect, health anxiety and symptom~     severity in their usual daily lives.~   "
2725|NCT03019692|"~     Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on~     ultrasound in extremely preterm infants. Papile classification is commonly used to grade the~     severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including~     periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to~     be associated with adverse neurodevelopmental outcomes.~      However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm~     infants has not been well described.~      Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is~     not well established.~      The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and~     follow their radiological, cognitive, motor and functional outcomes.~      The study will focus on postnatal files, and on images performed as part of the child's~     follow-up during hospitalization and after discharge.~   "
2726|NCT03019679|"~     In this study the investigators aimed to investigate whether there is a relation between~     polycystic ovary syndrome and serum endocan levels.~   "
2727|NCT03019666|"~     This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related~     donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with~     relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive~     non-Hodgkin lymphoma (NHL). The primary endpoint of the study is to determine the maximum~     tolerated dose (MTD) of NAM-NK cells while maintaining safety.~   "
2728|NCT03021694|"~     The importance of protein in nutrition is momentous to ones health. Dietary proteins are~     essentially nutritional because they contain amino acids, which the body uses to build its~     own proteins, as well as other molecules that are essential for life. Protein when consumed,~     travels through your digestive system and is absorbed. They then enter the blood for~     transport to bodily tissues, and therefore, can be detected by blood sampling. There are~     differing amounts of each amino acid found in different types of protein supplements.~     Certain amino acids (the essential amino acids) are helping in stimulating muscle growth and~     helping to maintain muscle mass and function. It is important to understand how quickly~     these amino acids can be detected in your blood as well as how they affect blood glucose~     (blood sugar) and insulin activity. Understanding the effects of protein type on changes in~     levels of blood amino acids, glucose and insulin will provide helpful insight for the~     suggestion of supplement use.~   "
2729|NCT03021681|"~     Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough,~     expectoration and asthma, and eventually develop chronic pulmonary heart disease ,chronic~     respiratory failure and even death. The current clinical treatments for these patients are~     symptomatic treatment cannot solve the problem of the damaged lung structure fundamentally.~     Recent studies show that bronchial basement the layer of cells is a kind of cells in the~     bronchial epithelial basal layer position, the specific expression of Krt5 antigen with the~     regeneration and repair of lung function , these cells have the activity similar to adult~     tissue stem cells. Its division and migration are more active and can continue to produce~     new cells to complement the death of other types of epithelial cells with functional~     plasticity which can be used to direct repair the bronchial and alveolar structures. It has~     been proved that bronchial basal cell transplantation can repair the damaged lungs of~     experimental animals . The bronchial basal cells from autologous tissue, so there is no~     immune rejection problem. Also because the bronchial basal cells derived from adult tissues~     which is a part of the body, so there is no risk of a tumor (in animal experiments, In~     animal experiments, bronchial basal cells transtracheal input 100 times in human dose still~     no tumor formation). In the early stage, patients with COPD (2 cases), bronchiectasis (2~     cases) and interstitial lung disease (1 case) received the treatment, and the overall effect~     was good. Diseases were alleviated and recovered to some different extend.The study was to~     brush bronchial basal cells through fiberbronchoscopy in COPD patients and cultured in~     vitro, and then through the bronchoscope transfusion to the lesion site. To preliminary~     evaluate the efficacy and safety of autologous bronchial basal cells in the treatment of~     chronic obstructive pulmonary disease.~   "
2730|NCT03021668|"~     Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a~     high perioperative complication rate. Surgical site infection is one of the most common~     complications after pancreaticoduodenectomy. In a retrospective review of all patients who~     underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679~     patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis,~     perioperative blood transfusion, operative time greater than 7 hours, preoperative~     chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure~     device, and vascular resection were associated with surgical site infection (all, p<0.05).~     On multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were~     independent predictors of surgical site infection (all, p<0.001). Studies in colorectal~     patients have found an estimated cost of up to $1400 per patient secondary to prolonged~     hospitalization, wound care, and wound complications in patients with procedures complicated~     by a surgical site infection. Furthermore, in another study of 1144 patients undergoing~     pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative~     complications delayed time to adjuvant therapy, decreased median survival.~      The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing~     using the standard Acelity vacuum dressing after suture on patients undergoing~     pancreaticoduodenectomy at highest risk of infection will result in a significant decrease~     in surgical site infection rate. The investigator(s) plan to perform a randomized control~     trial where the patients who have had pre-operative bile stent/drain placement and/or~     neoadjuvant chemotherapy will undergo closure with Prevena Peel & Place Dressing using the~     standard Acelity vacuum dressing after suture versus standard closure. The investigator(s)~     will then follow the participant(s) for 30 days postoperatively to determine surgical site~     infection and other perioperative complication rate.~   "
2732|NCT03021642|"~     This is a Phase I, open label, randomized, crossover trial to investigate the relative~     bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be~     randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B:~     reference, test. The reference treatment refers to the current Phase II film-coated tablet~     (5 * 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new~     Phase III film-coated tablet (1 * 500 mg film-coated tepotinib tablet).~   "
2733|NCT03021629|"~     Vitamin D deficiency is known to be significantly associated with high myopia. This study~     investigated the vitamin D status in patients with high myopia and primary open-angle~     glaucoma, in order to understand the relationship between high myopia and the development of~     primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia~     patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,~     25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.~   "
2734|NCT03021616|"~     This study will determine the cardiovascular effects of energy drink consumption in healthy~     individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®~     analysis.~   "
2735|NCT03021603|"~     Aims. This paper describes the study protocol of a manualized brief positive intervention~     (BHI). In addition, it reports the on the modification of a hope intervention based on the~     theoretical proposition - hope theory, and its feasibility when applying to palliative~     cancer and non-cancer patients.~      Background. Hope was found to account for therapeutic changes in clients with depressive~     symptoms or chronic pain. Nevertheless, little is known about the integration of such active~     ingredients to brief and low intensity psycho-therapeutic interventions to patients~     receiving palliative care were not adequately tested.~      Design. The study included two stages: (1) manual development, and (2) a single blinded~     randomized controlled trial.~      Methods. Participants will be randomly assigned in equal number into either the brief hope~     intervention or the controlled arm on completion of the baseline assessment. Participants of~     the intervention group will be receiving the four-week intervention, while those allocated~     to the control arm will be receiving the routine care and social chats. The intervention is~     a manualized program that consists of four sessions at weekly intervals (two face to face~     sessions and two telephone follow up in between). The core content is modified from an eight~     sessions hope therapy. Expert panel feedback and trial on targeted populations were~     completed. Four participants received the program to determine its acceptability prior to~     feasibility testing. The process and practical considerations were evaluated to allow~     refinement of the program and to ensure the quality of intervention.~      Outcome measures comprise of changes in state hope score and the depression scores measured~     respectively by State Hope Scale and Centre for Epidemiological Study Depression Scale. The~     secondary outcomes are the common signs and symptoms in cancer patients measured by The~     Condensed Memorial Symptom Assessment Scale. Data collection will be done prior to the~     intervention (baseline), immediately and one month after the intervention. Additional use of~     qualitative interview to explore their experiences in the intervention, including~     satisfaction with the intervention and the treatment fidelity will be conducted.~   "
2736|NCT03021590|"~     Comparison Efficacy of 14-day Triple Therapy between levofloxacin and sequential therapy~     with levofloxacin on the Eradication of Helicobacter Pylori in Syrian population~   "
2737|NCT03021577|"~     The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation~     atherectomy device, reduces the incidence of microcirculatory compromise as compared to~     older generation rotational atherectomy (RA) due to differences in the mechanism of~     athero-ablation.~   "
2738|NCT03021564|"~     Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive~     Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and~     prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ~     failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias~     or intra-hospital arrests are the subject of numerous publications, few studies specifically~     focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to~     produce a prospective epidemiological description of unexpected cardiac arrest in in French~     ICUs.~   "
2739|NCT03021551|"~     This is a prospective, observational, clinical study designed to evaluate the clinical~     utility of the ORI as an early warning for arterial hemoglobin desaturation during the~     induction of general anesthesia and tracheal intubation in obese patients undergoing~     elective surgical procedures.~   "
2740|NCT03021538|"~     This study seeks to determine if ECMO compared to cardiopulmonary bypass during lung~     transplantation has a beneficial effect on short-term outcomes after lung transplantation.~     We hypothesize that ECMO will have decreased transfusion requirements, intubation time,~     lesser primary graft dysfunction with no increase in major adverse events.~   "
2741|NCT03021525|"~     To evaluate the impact of perioperative, algorithm driven, hemodynamic therapy based on~     individualized fluid and cardiac output optimization on postoperative moderate and severe~     complications in patients undergoing major abdominal surgery including visceral, urological,~     and gynecological operations.~      In the proposed study, hemodynamic therapy is tailored individually to each patient, based~     on individual preload optimization by the functional parameter pulse pressure variation~     (PPV) and based on an individually titrated goal of cardiac index. The proposed study~     therefore further develops the concept of hemodynamic goal-directed therapy to individually~     set goals and is designed to assess its impact on morbidity and mortality.~   "
2742|NCT03021512|"~     Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia~     correction with monofocal intraocular lenses implantation are supposed to have sufficient~     uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant~     vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c)~     near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a~     series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses~     implantation, group 2: subjects with bilateral trifocal lenses implantation)~   "
2743|NCT03021499|"~     The purpose of this study is to assess the efficacy of Orelvo (voclosporin) compared with~     placebo in achieving renal response after 24 weeks of therapy in subjects with active lupus~     nephritis.~   "
2744|NCT03021486|"~     The goal of this clinical research study is to learn if chlorpromazine, high-dose~     haloperidol, or a combination of the 2 drugs can help to control the symptoms of delirium~     (loss of contact with reality) in patients with advanced cancer who did not respond to~     low-dose haloperidol. High-dose haloperidol doses are usually about 2-4 times the size of~     low-dose haloperidol.~      In addition, researchers want to learn if treating patients with these drugs can help to~     lessen any distress that their caregivers may be having.~      The safety of these drugs will also be studied.~   "
2866|NCT03020043|"~     Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option.~     In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on~     mortality and morbidity in a routine clinical setting in germany, the investigators~     initiated this Frankfurt registry.~   "
2745|NCT03021473|"~     This is a prospective, non-blinded, non-randomized, non-interventional study of the Oxygen~     Reserve Index (ORI) in a clinical setting. It is designed to evaluate the potential clinical~     utility of the ORI as an early warning of impending arterial oxygen desaturation and collect~     additional data characterizing the correlations with arterial blood oxygen content.~      Specific aims:~        -  evaluate the clinical utility of the change in the oxygen reserve index as an early~          warning of impending arterial oxygen desaturation in the critically ill patient~        -  characterize the correlations between the oxygen reserve index and the arterial oxygen~          content during pre-oxygenation and induction of general anesthesia in critically ill~          patients~   "
2746|NCT03021460|"~     This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients~     with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.~   "
2747|NCT03021447|"~     Postoperative pain is a significant postoperative problem and it could be persistent if~     proper management is not provided. However, each patient shows different intensity of pain~     and different sensitivity to analgesics even if they underwent same procedures. Therefore,~     it would be useful to find the way to predict the postoperative pain sensitivity.~      Propofol, a popular anesthetic agent, induces pain during injection, which can not~     completely prevented by opioid or lidocaine in some patients. This is considered to be~     related to patient's pain sensitivity and it might be associated with postoperative pain~     sensitivity.~      Therefore, the relation of propofol injection pain and postoperative pain intensity will be~     explored.~   "
2748|NCT03021434|"~     The present study is a cluster randomized control trial of low-cost microbiological water~     test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.~   "
2749|NCT03021421|"~     Purpose: This prospective, randomised, controlled, single-blind, multicentre study was~     designed to investigate the effects of peripheral nerve block methods (applied using~     unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee~     arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia~     period.~      Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA)~     Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was~     performed in the USA group, in the lateral position through the intervertebral space, with 2~     ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2%~     lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was~     used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters~     were recorded every 5 minutes until the end of the preoperative and perioperative operation~     periods and postoperative first analgesic application time.~   "
2750|NCT03021408|"~     Evaluation of the effectiveness of three different approaches for the rehabilitation of gait~     in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).~   "
2751|NCT03021395|"~     In this open-label, prospective clinical trial, the investigators enrolled acute myeloid~     leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease~     (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The~     MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.~   "
2752|NCT03021382|"~     The objective of this study is to evaluate the precision of semi-automated lumen boundary~     identification from coronary computed tomography angiography (cCTA) by current version of~     HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical~     coherence tomography (OCT) as reference standard.~   "
2753|NCT03021369|"~     The digital pleural drainage system Topaz+ by Medela is compared to the analogue system~     Atrium OCEAN by Maquet in patients undergoing cardiac surgery.~      The study is prospectively randomized with an all-comer setup. The patients are randomly~     selected for one of the systems. The surgery is performed in the standard fashion and chest~     tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal~     32 French drain is placed in every patient and pericardial and/or pleural drains are~     optional.~      The postoperative course does not vary from the clinical standard and the chest tubes are~     removed according to institutional standard. The clinical data about fluid amount, time of~     removal, air leaks, tamponade are routinely collected in a digital patient documentation~     system.~   "
2754|NCT03021356|"~     The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude~     Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and~     stress echocardiography in a randomized prospective study. Furthermore, the prostheses'~     influence on postoperative outcome will be compared using spiroergometry, quality of life~     questionnaire and heart failure biomarkers.~   "
2755|NCT03021343|"~     This study evaluates the role of colchicine in the prevention of atrial fibrillation in~     patients undergoing open heart surgery. Half of participants will receive colchicine and the~     other half will not~   "
2756|NCT03021330|"~     In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients~     will be randomized into 2 groups. In the experimental arm, patients receive DA induction~     regimen with intermediate dose of cytarabine. In the control arm, patients receive DA~     regimen with standard dose of cytarabine.The efficacy of induction therapy containing~     intermediate dose of cytarabine is evaluated and adverse events associated with treatment~     are recorded.The primary end point is overall survival.~   "
2757|NCT03021317|"~     ACTHAR is a FDA approved drug for MS relapses. The purpose of the study is to examine the~     efficacy of this agent in improving relapses as measured by advanced MRI and laboratory~     techniques:~        1. Advanced serial MRI studies on patients during and after an acute MS relapse. MRI will~          be performed at baseline, 1 month after the 1st dose of ACTHAR, and months 3, 6, and~          12. ACTHAR will be administered for 10 days. Patients will start ACTHAR within 48 hours~          of relapse assessment.~        2. Serial immune assays on patients during and after an acute MS relapse. Serum and blood~          samples with be collected at baseline, last day of ACTHAR (day 10 of therapy), 1 month~          post 1st dose, and months 3 and 6.~   "
13263|NCT02883647|"~     The study is to observe the therapeutic effects and long-term follow-up after ending~     anti-HBV therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.~   "
2758|NCT03021304|"~     This study is aimed to assess the correct real-world use of a safety syringe for the repeat~     self-administration of mepolizumab SC. This Phase III study will be an open-label,~     single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety~     syringe (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in~     subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a~     single injection that is self-administered in the thigh, abdomen or administered in the~     upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks~     including pre-screening visit, a screening visit and a 12-week treatment period which~     concludes with end of study assessments (Visit 5) 4 weeks after the last dose of~     mepolizumab. Approximately 55 Subjects will be enrolled in the study.~   "
2759|NCT03021291|"~     This study is designed to assess the effect of Gelesis100 on body weight after an additional~     exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at~     least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.~   "
2760|NCT03021278|"~     The purpose of this study is to determine whether experimentally induced acute low back pain~     might lead to alteration in lumbar tactile acuity measured in region affected by pain~     compared to pain-free side and pain-free controls.~   "
2761|NCT03021265|"~     Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio®~     Combination Tablets treatment in patients with hypertension~   "
2762|NCT03021252|"~     Clinical randomized clinical trial to assess the effectiveness of incorporating inspiratory~     and expiratory muscle training (IEMT) in the rehabilitation of stroke patients with~     dysphagia in terms of functional outcomes, comorbidities, survival and quality of life.~      This project also incorporates a longitudinal study to assess the clinical impact of~     dysphagia on body composition and nutritional status in stroke patients.~   "
2763|NCT03021239|"~     The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo~     Ramp Tests to determine which method of testing provides better information for adjusting~     pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better~     adjustments may provide better quality of life, exercise tolerance and reduced unwanted~     cardiac events over a 6-month period.~   "
2764|NCT03021226|"~     The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds~     on literature and existing research from the healthy marriage/responsible fatherhood~     initiatives developed by ACF over the last 10 years, in particular the Supporting Healthy~     Marriage Program initiative that established a randomized clinical trial. The Brothers~     United Fatherhood Program will provide important data to expand the area of fatherhood~     development with the target population. This program is funded through an initiative of the~     Administration for Children and Families, Office of Family Assistance (OFA).~      The study is intended to measure if the identified interventions improve the well-being and~     relationship between targeted participants and their families. The study intends to focus on~     the following outcomes:~        -  Demonstrate increased intake & knowledge of systems that help fathers~        -  Improvement in knowledge of employment & learn new opportunities for economic mobility~        -  Improvement communication & empathy skills towards partner~        -  Increase in understanding of healthy marriage & its value to fathers~        -  Demonstrate an understanding of financial planning~        -  Demonstrate improved conflict resolution, behavior patterns, including those leading to~          domestic violence~        -  Increase in reports of improved adult & child relationships~        -  Demonstrate an increase job readiness skills such as employment preparedness & career~          direction~   "
2765|NCT03021213|"~     Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD)~     therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower~     extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New~     York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.~   "
2766|NCT03021200|"~     The use of fluorescence for real-time evaluation of organ and tissue vascularization and~     lymph node anatomy is a recent technology with potential for the surgical treatment of~     cancer. The real-time analysis of tissue vascularization allows immediate identification to~     the surgeon of areas with greater or lesser blood circulation, favoring surgical decision~     making and prevention of complications related to tissue ischemia (necrosis, dehiscences and~     infections). It is a technology with potential application in the areas of Digestive~     Surgery, Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition,~     fluorescence can be used as a method to identify lymph node structures of interest in the~     oncological treatment of patients with urologic, gynecological and digestive tumors.~      Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through~     intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp.,~     Branchburg, N.J.) had its initial application in repairing surgery after breast cancer~     treatment. The method proved to be useful in the prevention of ischemic and infectious~     complications in cancer surgery. Pestana, in a prospective clinical series of 29~     microsurgical flaps used in several reconstructions, observed a single case of partial loss~     of the flap, the present technology having a relevant role in intraoperative decision~     making. In the same year, Newman et al. The first application of the system in breast~     reconstruction surgery. In an initial series of 10 consecutive cases of reconstruction with~     microsurgical flaps, in 4 cases the system allowed the intraoperative identification of~     areas of low perfusion, thus changing the surgical procedure. According to the authors,~     there was a 95% correlation between indocyanine laser assisted and subsequent development of~     mastectomy skin necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray~     et al. Evaluated the intraoperative perfusion, however, of the areola-papillary complex in~     patients submitted to subcutaneous mastectomies with satisfactory results in terms of~     predictability of cutaneous circulation. Other authors in larger clinical series and~     evaluating other procedures have observed valid results in terms of prevention of~     complications.~      Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a~     serious and common complication. These fistulas can be caused by insufficient perfusion of~     the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can~     be used to visualize the blood perfusion following intravenous injection of the indocyanine~     green contrast. Several groups reported the ability to assess blood perfusion of the~     anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and~     colleagues described a reduction in the risk of revision due to fistula in 60% of patients~     whose anastomosis was examined using laser fluorescence angiography compared to historically~     paired patients without this method. The same principle can be used to evaluate the~     tubulized stomach to be transposed to the cervical region after subtotal esophagectomy.~      Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer~     as well as investigative character in colorectal cancer, skin cancer, cervical cancer,~     vulvar cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric~     cancer and esophageal cancer.~      These early studies demonstrated the feasibility of this methodology during surgery.~     Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can~     replace blue dyes because they exceed them due to increased tissue penetration depth and~     absence of staining in the patient and cleaning of the operative field.~      To date, there are no clinical studies involving intraoperative perfusion mapping and~     identification of lymph node structures with the SPY Elite System © system or other~     platforms (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an~     objective way the influence of this technology as predictive in the better or worse~     evolution of the oncologic surgery as well as in the prevention of the local ischemic~     complications by means of intraopeal change of conduct~   "
2767|NCT03021187|"~     This trial is conducted globally. The aim of the trial is to investigate the efficacy and~     safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated~     with insulin. All subjects should continue their pre-trial insulin therapy (basal,~     basal-bolus or premixed regimen including combinations of soluble insulins) throughout the~     trial. Subjects treated with metformin in addition to insulin treatment must continue their~     metformin treatment throughout the entire trial.~   "
2768|NCT03021174|"~     This is a feasibility pilot study to initiate a research program to assess the effects of~     exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the~     hands and feet).~   "
2769|NCT03021161|"~     This project will be test the effect of probiotics on occupational allergic sensitization,~     respiratory symptoms and bronchial hyperresponsiveness in workers or students that develop~     respiratory symptoms exposed to laboratory animals, i.e., small rodents.~   "
2770|NCT03021148|"~     It has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even~     though they do not have celiac disease or wheat allergy. This clinical condition has been~     named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested~     the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of~     wheat causes the symptoms in NCGS patients, and the investigators also showed that these~     patients had a high frequency of coexistent multiple food hypersensitivity. To our~     knowledge, there are very few studies which assessed the prevalence of self-reported~     gluten-related symptoms in the community and analyze diagnostic outcomes in those referred~     to secondary gastrointestinal care. In one of these, performed in UK, the authors showed~     that gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming~     a gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of~     celiac disease. Of those patients presenting to the gastroenterology department, the~     majority do not have CD but NCWS. No data are available for boys and girls. Therefore, the~     aims of this study were 1) to determine the prevalence of self-perceived gluten-sensitivity~     in a population of high-school students, and 2) to evaluate the demographic and clinical~     differences between students self-reporting gluten sensitivity and students not reporting~     food hypersensitivity.~   "
2771|NCT03021135|"~     Randomized, comparative and prospective study between Conventional Endoscopic Mucosal~     Resection for the removal of flat or sessile colorectal lesions without previous attempt to~     resection.~   "
2772|NCT03021122|"~     The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or~     divisions to prepare continuous infusions of vasoactive drugs during a simulation-based~     pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to~     prepare and deliver vasoactive drugs following their current conventional methods or by the~     aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them~     step-by-step from order to delivery of these drugs.~        1. Primary outcome will be to measure in each allocation group the number of medication~          dosage errors committed during each drug preparation sequence until injection.~        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to~          drug delivery (TDD).~   "
2773|NCT03021109|"~     The purpose of the study is assessment of volume status by bedside ultrasound in children~     with acute gastroenteritis~   "
2774|NCT03021096|"~     This study aims to identify the timeline of pain following total shoulder replacement with~     the goal of developing data for a subsequent randomized trial. The investigators believe~     that with using HSS's current protocol, many patients have postoperative pain that is no~     worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder~     arthroplasty patients have not formally followed patients past their hospital discharge, and~     the investigators believe that some patients do experience moderate to severe subacute~     postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain~     scores at 14 days after surgery. Future studies will look at measures of preventing bruising~     and subsequent pain after shoulder replacement.~   "
2775|NCT03021083|"~     The treatment of postoperative pain continues to be a challenge after posterior spinal~     fusions. There is considerable evidence demonstrating that a multi-modality approach~     including patient controlled analgesia (PCA) with opioids for postoperative pain management~     compared to conventional opioid analgesia provides a greater analgesic effect even when the~     amount of opioids consumed is similar between both groups. However, the PCA modality is~     often discontinued prior to all the patients' pain needs being met. The IONSYS system uses~     the concept of PCA-delivered narcotics and may be used for postoperative pain management.~   "
2776|NCT03021070|"~     Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that~     can tackle the high burden of maternal and child mortality and morbidity currently witnessed~     in sub-Saharan Africa. However very few pregnant women utilize these services. This study~     aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers~     (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal~     healthcare system in Siaya County, Kenya.~      The study is a cluster randomized controlled trial with the intervention being a conditional~     cash transfer to women each time they honour their health appointments for ANC, facility~     birth and PNC visits until their new-borns reach 1 year of age. Study participants are~     pregnant women identified during their first ANC visit (n = 7200), and their subsequent~     new-borns. Mothers and their children are followed up throughout their health visits and at~     3 additional time points. Trial clusters are 48 public primary health facilities, (24 in the~     intervention arm and 24 in the control arm).~      The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b)~     delivery at health facility; c) proportion of all eligible PNC visits honoured; d)~     proportion of referrals honoured during pregnancy and postnatal period; e) proportion of~     child immunizations received. Secondary outcomes include; health screening and infection~     control, live birth, maternal and child survival 48 hours after delivery, exclusive~     breastfeeding, birth spacing and self-rated wellness of mother and new-born at respective~     time points.~      Primary outcomes will be measured through abstraction of health records at the health~     facilities attended by the women during the trial period and supplemented by data collection~     using an electronic based system that comprises of a card and reader system installed at~     recruited study facilities. Secondary data will be abstracted from the women's medical~     records at the health facilities and supplemented by telephone surveys administered at three~     time-points over the course of the study. Additional quantitative and qualitative data will~     be collected through questionnaires and phone interviews for process and economic~     evaluations.~      This trial will contribute to evidence on effectiveness and cost-effectiveness of~     conditional cash transfers in facilitating health visits and promoting maternal and child~     health in Kenya and other similar contexts.~   "
2777|NCT03021057|"~     Conventional chemotherapeutic regimens designed for aggressive B-cell lymphomas are~     generally less effective when applied to mature T-cell or NK-cell lymphomas. The treatment~     outcome for relapsed or refractory disease is especially poor.~      This is a single centre, prospective, non-randomized, open-label, phase II study to evaluate~     the efficacy of pembrolizumab in patients with relapsed or refractory mature T-cell or~     NK-cell lymphomas. Patients will receive pembrolizumab 200mg i.v. once every 3 weeks until~     disease progression or unacceptable toxicity.~      A baseline radiological assessment by positron emission tomography / computed tomography~     (PET/CT) scan is obtained before commencement of treatment. Tumor response and progression~     are evaluated by physical examination, standard laboratory tests, and PET/CT scan according~     to standard criteria. Standard response criteria for non-Hodgkin lymphomas are used for~     assessment . PET/CT scan will be done at week 12, week 24, week 36 and every 18 weeks~     thereafter.~   "
2778|NCT03021044|"~     RATIONALE AND OBJECTIVE OF THE STUDY~      Patients with low functional capacity (frail patients) with cardiovascular disease, in~     particular those undergoing invasive procedures or suffering from coronary artery disease,~     have a much higher adverse events, death and re-hospitalizations. and complications,~     suggesting the need for a more accurate functional stratification and a more careful~     evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc~     physical activity intervention could be improve functional autonomy of these patients early~     after discharge with benefit on long-term outcome. The present study is performed to assess~     the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical~     activity early after discharge in elderly patients aged 75 years and older with low physical~     performance.~      This is an interventional, multicenter, prospective, randomized, phase III study. The~     present study is expected to enroll elderly patients admitted to hospital for acute coronary~     syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB score~     predischarge. At the moment of discharge there will be a screening: patients with SPPB score~     0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with SPPB~     score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If SPPB~     score will be 0-3 or 10-12, patients will be considered screening failure and will be~     followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to~     standard of care (see below) or to an ad hoc physical activity program (see below). The aim~     of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1~     point) in patients randomized to physical activity intervention versus patients randomized~     to standard of care. All patients will be evaluated until 3 years after randomization.~   "
2779|NCT03021031|"~     The goal of this project is to provide comprehensive longitudinal assessments of a cohort of~     PD patients before, during, and after DBS surgery, including neurological,~     neurophysiological, and neuropsychological data.~   "
2780|NCT03021018|"~     The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)~     compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy~     Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.~   "
2890|NCT03019380|"~     Wondertip is a silicone single use device with a coil end, designed for the purpose of~     evacuating impacted cerumen of external ear canals. This trial aims at testing the safety~     and efficacy of this device. The participating investigators will be ENT doctors with the~     skill of examining the treating ear problems.~   "
3913|NCT03005990|"~     This study will explore the long-term effects of exercise training on body composition,~     cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with~     sleep disturbances~   "
2781|NCT03021005|"~     The proposed pilot research has three aims: 1) to determine the feasibility and~     acceptability of provision of HIV self-testing kit in order to increase uptake and~     engagement of HIV testing among emergency department patients who decline conventional~     emergency department HIV testing and to increase the engagement of HIV testing at a regular~     basis for those with an increased risk for HIV (the index participants); 2) to determine the~     uptake and engagement of HIV testing by provision of HIV self-testing kit; and 3) to~     determine the feasibility and acceptability of HIV self-testing kit referral among partners~     or peers of the index participants.~      The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency~     department on (1) patients who decline routine HIV testing offer and (2) patients who are at~     an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit~     group which we will provide a free Food and Drug Administration-approved HIV self-testing~     home kit for the participant to take it home or to reference group which the investigators~     will not provide the self-testing kit. Consented patients in both groups will fill out a~     short survey regarding their socio-demographic information as well as their experience and~     perceptions regarding HIV testing. For patients who are in the HIV self-testing kit group,~     they will be asked if they would like to take a free HIV self-testing home kit home.~     Participants in this group will also receive information regarding how to access I Want The~     Kit website to report the completion of HIV self-testing at home. For patients who are in~     the reference group, a standard pamphlet regarding the importance of HIV testing and HIV~     testing venues in Baltimore City used by emergency department-based HIV testing program will~     be provided to the patients.~      Follow-up questionnaires will inquire regarding the patient's experience regarding HIV~     testing since their index visit.~      When the participants in the HIV self-testing kit group in Aim 1, they will also be provided~     5 referral cards for their partners and peers for them to request a free HIV self-testing~     kit from the I Want The Kit website. At the 1-month phone follow-up, the investigators~     will ask participants if they are able to give the referral cards to their partner(s) or~     friend(s), how they think if their partner(s) and/or friend(s) will request an HIV~     self-testing kit from the I Want The Kit website.~   "
2782|NCT03020992|"~     The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment~     on the reduction of Anterior Uveitis (AU) flares in subjects with active axial~     Spondyloarthritis (axSpA) and a documented history of AU~   "
2783|NCT03020979|"~     Malignant ascites is a severe complication of many types of human cancer. Animal and~     clinical analyses have shown that angiogenesis plays a critical role in the formation of~     malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control~     the development of malignant ascites. The study is to evaluate the efficacy and safety of~     apatinib in patients with refractory malignant ascites.~   "
2784|NCT03020966|"~     The purpose of this study is to determine how well two different methods of administrating~     Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR)~     surgery. The methods of administration are orally, via a pill that is to be swallowed, and~     intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol~     will reduce opioid consumption and opioid-related side effects after THR.~   "
2785|NCT03020953|"~     Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12~     weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of~     17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength~     in postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type~     specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein~     (western blotting), satellite cell proliferation and activation, Strength, functional test,~     muscle protein synthese.~      Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not~     performed regular resistance exercise (<1 times per week) the last two years. Randomized,~     controlled intervention study +/- transdermal administration of estrogen (17-β estradiol).~     Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming~     to induce muscle hypertrophy in the legs.~   "
2786|NCT03020940|"~     1. National, large-scale, standardized, standardized, real-world research;~        2. Prospective, single - arm open, non - interventional, registration, multi - center~          clinical study;~        3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the~          principle of voluntary selection of 200;~        4. registration of the use of cefuroxime axetil dispersion tablets patients;~        5. Target sample size of 100,000 cases;~        6. Exemption from informed consent for ethical review applications;~        7. Antibiotic drug safety re-evaluation of large data.~   "
2787|NCT03020927|"~     The purpose of this study is to examine whether adding a parent education component to an~     existing intervention (Reciprocal Imitation Training) results in improved outcomes for~     children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral~     intervention designed to improve spontaneous imitation skills in young children with Autism~     Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by~     trained therapists, teachers, siblings, and parents of children with ASD. However, it is~     unclear to what extent training parents to use RIT strategies in the home environment may~     enhance outcomes, compared to having therapists implement RIT individually with the child.~     The study will compare two different versions of RIT for young children with ASD: (1) two~     60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session~     of therapist-implemented RIT and one weekly 60-minute session of parent education about~     using RIT in the home environment. The investigators will examine child and family outcomes~     between these two intervention types. Outcomes examined will include: (1) spontaneous and~     prompted imitation skills in the child with ASD, (2) social communication skills in the~     child with ASD, (3) parent stress, and (4) parent and child behaviors during parent-child~     play interactions.~   "
2788|NCT03020914|"~     Patients will be randomly assigned to either one of two groups:~        1. Standard of care sedation~        2. Audiovisual distraction during surgery and in the recovery room using video goggles and~          headphones; patients can choose a movie from a preexisting library~      Monitoring and anesthesia regimen will be standardized~   "
2789|NCT03020901|"~     1. Primary study endpoint Security Effectiveness~        2. Secondary study endpoint Extensive use of population characteristics Clinical drug~          characteristics appropriate crowd characteristics Adverse reactions susceptible~          population characteristics Reveal rare, new, unanticipated and long-term adverse drug~          reactions bacterial resistance Explore the advantages of teicoplanin in combination~          with other antimicrobial agents Explore the opportunistic use of teicoplanin for~          injection~   "
2790|NCT03020888|"~     The purpose of this post-marketing study is to provide prospective evidence that the Magseed~     and Sentimag® is effective for lesion localization in patients undergoing surgical excision~     of a breast lesion and to summarize measures of product safety and performance.~   "
2891|NCT03019367|"~     This study is being done to find out whether umbilical cord milking (UCM) is at least as~     good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or~     prevent death in premature newborns. The investigators will study short and long term~     outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC.~   "
3928|NCT03005795|"~     To assess the effect of music during colposcopy on women´s anxiety.~   "
3929|NCT03005782|"~     In dose escalation: safety and PK In dose expansion: response rate~   "
2791|NCT03020875|"~     The United States is currently experiencing an explosive opioid epidemic. In 2014 alone,~     28,647 Americans died from an opioid associated overdose; the annual death toll has~     increased by over 300% since 2000. The epidemic poses a complex scenario for physicians~     administering treatment for postoperative pain, as opioids are key analgesic agents in~     treating moderate to severe pain. In order to reduce the patients risk for long term opioid~     use and the associated side effects, physicians have begun shifting to multimodal analgesic~     approaches to treat postoperative pain. These approaches have been found to be similarly~     efficacious, while also reducing opioid usage and associated side effects, such as: nausea,~     vomiting, and ileus.~      This study proposes a multimodal analgesic approach, which the investigators believe will~     reduce short and long term opioid usage, the associated side effects, and the financial~     burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive~     pain management, however its use is limited by a high cost to perceived benefit ratio. Oral~     acetaminophen is a relatively inexpensive option, although perhaps less effective than the~     IV option, and also often not feasible to utilize in the immediate post-operative period~     when patients are unable to safely swallow pills. The hypothesis of this investigation is to~     understand if adding intravenous acetaminophen to the perioperative care regimen after~     lumbar spinal surgery will result in improved pain management in the perioperative period~     while decreasing opioid usage and related complications.~   "
2792|NCT03020862|"~     The purpose is to evaluate exercise performance in patients with Chronic Obstructive~     Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to~     previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate~     oxygen consumption of submaximal cycling, amendments in blood pressure, and physical~     activity level.~   "
2793|NCT03020849|"~     In this retrospective and prospective study, the aim is to determine a score for predicting~     a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of~     fibrinogen concentrates)~   "
2794|NCT03020836|"~     Investigators conducted a clinic-based study to determine the magnitude of uncontrolled~     hypertension and current smoking in eye doctor's offices and sought to determine if referral~     to care results in actions taken by the patient.~   "
2795|NCT03020823|"~     The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of~     SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous~     platinum based therapies.~   "
2796|NCT03019653|"~     The purpose of this study is to look at kidney function and hormonal function in patients~     with a history of heart failure and kidney dysfunction, and to see how the use of a new~     drug, ANX-042, affects those functions.~   "
2797|NCT03019640|"~     The goal of this clinical research study is to learn about the safety of giving immune cells~     called natural killer (NK) cells with chemotherapy and a stem cell transplant to patients~     with non-Hodgkin's lymphoma. Participants will receive an autologous stem cell transplant (a~     transplant of participant's own bone marrow or blood cells).~      NK cells may kill cancer cells that remain in participant's body after participant's last~     chemotherapy treatment. The NK cells will be separated from a donor's umbilical cord blood.~     These separated NK cells will then be grown in the lab to increase the number of NK cells~     that can be given to participant by vein. If certain types of unwanted T cells are growing~     too much, an investigational device called a CliniMACS system will be used to filter out the~     unwanted T cells using a magnet.~   "
2798|NCT03019627|"~     The phase II study is a single-center, randomized, double-masked, parallel-arm,~     vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human~     Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily~     for 8 weeks in patients with dry eye.~   "
2799|NCT03019614|"~     This was an open label, randomized, single dose, three period crossover pharmacokinetic~     study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub~     groups (Group 1, n=18 and Group 2, n=12).~   "
2800|NCT03019601|"~     A specific organized program utilizing peers in the PMTCT clinic who provide family planning~     information and support to HIV infected mothers was compared to providing standard family~     planning messages currently used in the clinic.~   "
2801|NCT03019588|"~     The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475)~     versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with~     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after~     failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.~      The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared~     to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response~     Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central~     radiologists' review compared to paclitaxel.~   "
2802|NCT03019575|"~     The purpose of the study is to investigate whether corifollitropin alfa (MK-8962),~     administered in combination with human chorionic gonadotropin (hCG), increases the~     testicular volume in adolescent males aged 14 to <18. In addition, the study will evaluate~     participants for the development of corifollitropin alfa antibodies over the course of 64~     weeks of treatment.~   "
2803|NCT03019562|"~     Oxycodone is one of the most widely used opioids for pain treatment. Many studies~     demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the~     efficacy and side effects of bolus intravenous of oxycodone injection compared to those of~     fentanyl in patients after total hip replacement surgery.~   "
2804|NCT03019549|"~     The purpose of this study is to evaluate the effect of LY3314814 on rosuvastatin. The amount~     of rosuvastatin in the blood will be compared, when taken alone, and then when taken with~     LY3314814. The amount of LY3314814 that gets into the bloodstream will be measured.~     Information about any side effects that may occur will also be collected.~      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.~      Screening will be undertaken within 45 days prior to enrollment.~   "
2805|NCT03019536|"~     The study involves repeated doses of LY3303560 given by injection over 48 weeks. The study~     will examine how safe repeated doses of LY3303560 are, whether they cause side effects in~     participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is~     handled by the body and acts in the body. This study will last about 64 weeks, not including~     screening. Screening is required within 70 days prior to the start of the study.~   "
2806|NCT03019523|"~     This is a cross-over design study in which subjects arrived to the lab and were assigned a~     supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing~     along with a questionnaire. Thirty minutes after ingestion subjects filled out the same~     questionnaire, completed a reaction time test, followed by a series of dynamic exercises.~     After the last exercise was finished subjects filled out the questionnaire, completed~     another reaction time test and repeated the series of dynamic exercises. Following the~     exercises, subjects filled out the questionnaire and completed a fourth round of reaction~     time testing. In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of~     reaction time testing with heart rate being recorded before and after the dynamic exercise~     rounds. Subjects were told to wash-out for 7 days and return to the lab to complete the same~     testing but on the alternative supplement.~   "
2807|NCT03020810|"~     This is a single patient expanded access, compassionate and non-emergency use study that~     provides patients with severe asthma, who do not qualify for ongoing clinical trials with~     dupilumab, access to this investigational treatment.~   "
2808|NCT03020797|"~     This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The~     investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved~     by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel~     will be used off-label for adults with ALS at an oral medication dose on the low end of the~     recommended dose range for epilepsy. This study will consist of two treatments arms:~     perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication~     for 9 months.~   "
2809|NCT03020784|"~     Safety, Tolerability and Pharmacokinetics of PF-06818883~   "
2810|NCT03020771|"~     This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA)~     vaccine on humans (healthy volunteers), which has been developed in Turkey and has completed~     preclinical toxicology studies to be performed on experimental animals. Also, this study is~     a Phase I, randomized, double-blind, national, single-center, placebo-controlled study that~     is designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)~     healthy male and/or female volunteers will be participating in this study, and the study is~     planned to last approximately one year.~   "
2811|NCT03020758|"~     This is a 2-period randomized crossover study with free-living subjects on self-selected~     diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried~     plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack~     food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who~     are representative of the U.S. population and at risk for cardiovascular disease~     (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).~      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood~     pressure and LDL-cholesterol, and improve artery function (assessed by standard blood~     pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial~     stiffness) compared to the control group and baseline.~   "
2812|NCT03020745|"~     GSK3389404 is being developed for the treatment of CHB virus infection. The development goal~     for GSK3389404 is the establishment of a finite duration treatment that results in sustained~     suppression of hepatitis B virus (HBV) replication and viral antigen production after~     cessation of all treatments for CHB due to the restoration of a functional immune response~     in the absence of high antigen levels. This study is a multicenter, randomized double-Blind~     (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety,~     tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish~     proof-of-mechanism. The study will be conducted in two parts. Part 1 will be conducted as a~     single ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a~     maximum of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive~     either GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in~     a sequential fashion; Cohort C1 may be dosed after Cohort C or in parallel with Cohort D.~     Part 2 will be conducted as a multiple-dose, dose-ranging study. Subjects will be randomized~     to different parallel dose levels and regimens or placebo. Part 2 will be selected after a~     review of Part 1 safety but will not exceed a total monthly dose of 240 mg. The total study~     duration for part 1 including screening, treatment, and post-treatment follow-up, will not~     be expected to exceed 13 weeks for each subject and for part 2, including screening,~     treatment and post-treatment follow-up, will not be expected to exceed 29 weeks for each~     subject.~   "
2813|NCT03020732|"~     Platelet concentrates(PC) are used in the field of periodontology and implantology for the~     content necessary key cells and growth factors to accelerate healing and to provide~     regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new~     generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness~     of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's~     and subepithelial connective tissue graft(SCTG) with CAF in the treatment of multiple Miller~     class I gingival recessions (GR).~   "
2814|NCT03020719|"~     The purpose of this randomized, placebo-controlled (Phase II) study will be to further~     evaluate the effects of oral glutathione on growth in children with CF.~   "
2815|NCT03020706|"~     The purpose of this study is to evaluate the effect of magnesium sulphate on~     neostigmine-induced reversal of neuromuscular block by rocuronium~   "
2816|NCT03020693|"~     This study evaluates the effectiveness of an electrostimulation treatment with TENS using a~     needle and a surface electrode combined with an exercise program to fasciitis plantar. Half~     participants will receive invasive electrostimulation (TENS using a needle) and exercises~     while the other half will receive electrostimulation placebo and exercises.~   "
2892|NCT03019354|"~     In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion~     ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen~     therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It~     has physiological effects: reduction of anatomical dead space, positive end expiratory~     pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The~     hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia~     could improve lung function and prevent lung atelectasis.~   "
5210|NCT02989012|"~     Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled,~     multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the~     symptoms of influenza.~   "
2817|NCT03020680|"~     Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in~     the body via complicated biochemical pathways. It exists in both reduced and oxidized~     states, namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell~     membranes. The main function of CoQ10 is to participate in energy production. Further, the~     reduced form of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to~     protect free radical induced damages to DNA, lipid, and proteins. Given that older adults~     have increased production of free radicals, suboptimal antioxidant defenses toward free~     radicals, and a decreased capability to replenish utilized CoQ10, CoQ10 supplementation can~     be one of feasible ways to increase CoQ10 status in order adults. Most supplements available~     for consumers are in the oxidized form. While the ubiquinol form is also available, whether~     the reduced form will be more effective to replenish CoQ10 status in older subjects remains~     to be explored. Thus, investigators aimed to examine whether ubiquinol will be more~     effectively absorbed in older adults with a low antioxidant defense status. To pursue this~     aim, investigators will conduct a double blind, randomized, crossover design trail with 5~     study visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2)~     with a compromised antioxidant defenses will be recruited and complete the trial. Eligible~     subjects will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with~     2-week washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in~     blood will be assessed to reveal whether the reduced form, ubiquinol, is more absorbable~     than the oxidized form, ubiquinone in older adults.~   "
2818|NCT03020667|"~     The Tobacco Heating System (THS 2.2) which is commercialized under the iQOS brand name (as~     described in the study protocol) in Japan is subject to an assessment program which includes~     post-market studies such as the Japanese Post-Market Cohort Study.~      The objectives and endpoints of this Post-Market Cohort Study will be analyzed in the study~     population of adult tobacco users and never smokers in Japan. This includes:~        -  Provide a perspective of tobacco product use in a real world setting, where~          simultaneous use of tobacco and nicotine containing products may occur,~        -  Describe population-level changes in biomarkers of exposure (BoExp) following long~          duration of CC and THS 2.2 use,~        -  Evaluate whether there is a difference in the levels of selected clinical risk~          endpoints (CREs) between CC smokers and THS 2.2 users.~      This study is divided in 2:~        -  Main Study: the Main Study will describe the patterns of use of tobacco and nicotine~          containing products and self-reported health outcomes and health related events in CC~          smokers and THS 2.2 users. THS 2.2 users and CC smokers will be identified and invited~          for participation in the study until each annual wave of 500 participants for each~          product is filled.~        -  Clinical Sub-Study: the Clinical Sub-Study will further assess the population level~          differences in BoExp to harmful and potentially harmful constituents (HPHCs), CREs, and~          self-reported symptoms and health outcomes between CC smokers, THS 2.2 users and~          never-smokers, the latter group only included in the Clinical Sub-Study. THS 2.2 users~          enrolled in the Main Study will be invited to enroll in the Clinical Sub-Study where~          clinical assessments will be performed and biological samples (blood, serum, plasma,~          and urine) will be collected. There will be two clinical study visits, which will take~          place at Month 12 (Visit 1) and Month 36 post product initiation (Visit 2).~      Participants will be recruited into the cohort in annual waves over a period of 4 years.~   "
2819|NCT03020654|"~     This study investigates the use of virtual environments presented on a head mounted display~     for the rehabilitation of those suffering with visual vertigo.~      The control group and treatment groups will be presented with two different sets of~     environments and be given the same head and eye exercises to complete within the~     environment. They will also be provided with at home exercises to complete.~   "
2820|NCT03020641|"~     The investigators hypothesized that applying a low intraperitoneal pressure pneumoperitoneum~     (≤ 8mmHg) during laparoscopic cholecystectomy, the adverse impact on the surgical peritoneal~     environment (measured as gene expression of extracellular matrix, adhesion and inflammatory~     cytokine as well as oxidative stress response and apoptotic index), can be minimized and~     probably clinical outcomes might be better.~   "
2821|NCT03020628|"~     This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose~     of this study is to assess the immunogenicity and safety of the quadrivalent cell~     culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza~     vaccine in children aged 6~35 months.~   "
2822|NCT03020615|"~     This is a pilot study, single-blind, randomized, multicenter, therapeutic clinical trial~     designed to evaluate the feasibility of enrolling infants and toddlers (9 months to 36~     months) with sickle cell anemia (SCA; HbSS or HbSβ0thalassemia), regardless of disease~     severity, to a therapeutic trial. A prior clinical trial at St. Jude Children's Research~     Hospital (SJCRH) (BABYHUG, NCT01783990) demonstrated that a fixed dose (20 mg/kg/day) of~     hydroxyurea was safe and effective in decreasing SCA-related complications in very young~     children (9-18 months), and largely due to these findings, hydroxyurea is recommended to be~     offered to all children (≥9 months old) with SCA, independent of disease severity.~     Nevertheless, children in the treatment arm of BABYHUG continued to experience~     vaso-occlusive symptoms and to incur organ damage. In clinical trials of older children with~     SCA, intensification of hydroxyurea to a maximum tolerated dosage (MTD), defined by mild to~     moderate myelosuppression, may be associated with improved laboratory parameters compared to~     fixed lower-dosing, but the clinical benefits gained from dose intensification have not been~     described. Therefore, in this trial, children in the standard treatment arm will receive a~     fixed dose of hydroxyurea (20mg/kg/day), and participants in the experimental arm will~     receive hydroxyurea intensified to MTD, defined by a goal absolute neutrophil count (ANC) of~     1500-3000 cells/µL. This trial aims to establish a multicenter infrastructure that will~     identify, enroll and randomize very young children (9-36 months) to receive fixed dose~     versus intensified-dose hydroxyurea in a single blinded manner, and to obtain prospective~     pilot data comparing the clinical and laboratory outcomes between the treatment arms to~     facilitate design of a definitive phase III trial.~   "
2823|NCT03020602|"~     This phase I trial studies the side effects and best dose of ubidecarenone injectable~     nanosuspension (BPM31510) in treating patients with glioblastoma or gliosarcoma that has~     come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
2824|NCT03020589|"~     Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough~     levels and clinical outcomes. The primary endpoint of this study is to evaluate the~     proportion of patients reaching target levels (8-10 ng/ml) on Day 3 and Day 7 after kidney~     transplantation.~   "
2893|NCT03019341|"~     The prevalence of nausea and vomiting after the administration of non-ionic contrast media~     has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk~     factors of nausea and vomiting after the exposure to the non-ionic contrast media for~     computed tomography examinations in adults.~   "
4670|NCT02996110|"~     The purpose of this study is to determine whether nivolumab in combination with other~     therapies is more effective than nivolumab in combination with ipilimumab in treating~     patients/subjects with advanced renal cell carcinoma.~   "
2825|NCT03020576|"~     Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are~     often not effective in restoring full function of the upper limb. Specifically, many~     individuals remain with weakness in the hand, preventing its return to full use.~      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such~     as the InMotion2, have been shown to be useful in restoring some motor function in the upper~     limb. However, most existing devices designed to be used with the upper limb have primarily~     been developed to treat the shoulder, elbow and wrist. They have not specifically addressed~     hand function.~      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide~     rehabilitation for patients with neurological or orthopedic deficits in hand function.~     Initial clinical testing has demonstrated the practicality of using this device in a~     population of stroke survivors, although further research is needed to better understand the~     usefulness of the Amadeo device as compared with conventional rehabilitation methods. The~     purpose of this study was to compare results of training with the Amadeo device or training~     with conventional therapies.~      A total of 28 subjects from two separate sites participated in the study and underwent~     baseline testing of upper limb motor and sensory performance and function. Subjects were~     then assigned to one of two treatment groups with a 50:50 chance of being in either group.~     One group underwent training with the Amadeo device and the other group underwent training~     with conventional therapy. All training sessions were 60 minutes in duration, three~     days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the~     training program.~   "
2826|NCT03020563|"~     To determine whether liposomal bupivacaine wound infiltration decreases pain scores and~     narcotic use when compared to bupivacaine alone after open reduction internal fixation of~     midshaft clavicle fractures.~   "
2827|NCT03020550|"~     This is a pilot study measuring physiologic and behavioral correlates of symptom severity in~     adult patients with gastroesophageal reflux disease (GERD).~   "
2828|NCT03020537|"~     In this exploratory study, investigators will be looking at immune response differences~     between age groups and between the two different vaccines given to identical twins and~     vaccine-naive young adults.~   "
2829|NCT03020524|"~     A single cohort, open-label pilot study of the safety and tolerability of a single infusion~     of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the~     CXCR4 N-terminus using a lentiviral vector in HIV-infected subjects. This is a first in~     human study of C34-CXCR4 T cells~   "
2830|NCT03020511|"~     Recently it has been reported that a consistent percentage of the general population~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have celiac disease or wheat allergy. This clinical condition has~     been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators~     suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what~     component of wheat causes the symptoms in NCGS patients, and the investigators also showed~     that these patients had a high frequency of coexistent multiple food hypersensitivity. It is~     also believed that this condition is worldwide increasing, due to the evolution of wheat~     breeding (i.e. consumption of wheats with high gluten content), and that ancient wheat~     flour varieties are better tolerated by NCWS patients than the modern ones. This effect~     could be related to a lower immunogenic stimulation of the ancient wheat than the modern~     ones. The aim of the study is to evaluate the effect of a diet based on ancient grains in a~     closed community (i.e. nuns from enclosed religious order) as regard to 1) main~     haematochemical parameters and vitamins, 2) intestinal microbiota (bacterial flora), and 3)~     cytokines production from peripheral blood mononuclear cells (PBMC), before and after the~     diet period (30 days) with ancient grains.~   "
2831|NCT03020498|"~     In this exploratory study, investigators will be looking at immune response differences~     between age groups and between the two different influenza vaccines given to identical twins~     and vaccine-naive young adults.~   "
2832|NCT03020485|"~     The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose~     in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide~     important information on the potential health benefits of isomaltulose consumption in Asian~     population. It will also reveal how the three main ethnicities in Singapore respond to~     isomaltulose and whether the response differs from the Caucasians.~   "
2833|NCT03020472|"~     This pilot study will investigate the peak of the post-immunization B-cell responses~     following vaccination with live, attenuated influenza vaccine in healthy children 2 years of~     age from blood samples taken at designated time points before and after vaccination.~   "
2834|NCT03020459|"~     To compare the morphologic and functional outcomes of internal limiting membrane~     peeling-reposition versus peeling in idiopathic macular holes~   "
2835|NCT03020446|"~     To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous~     leg ulcers.~   "
2836|NCT03020433|"~     The investigators ultimate goal is to personalize brain stimulation for stroke so outcomes~     of the upper limb can be maximized for each individual patient. Several groups including the~     investigators have recently theorized that personalizing stimulation so as to selectively~     stimulate iM1 in mild, and cPMd in patients with greater severity would help generalize~     benefits of stimulation. The investigator premise that variances in expressions of~     plasticity can explain how to best stratify patients for robust, personalized stimulation.~   "
2837|NCT03020420|"~     This study tries to prove that Cicatricell cream significantly reduces scarring with better~     wound appearance as compared to no treatment.~   "
2838|NCT03020407|"~     The primary aim of this study is to evaluate the 30-day mortality outcome of the septic~     shock patients who are treated with ultrasound-assisted fluid management using change of the~     inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared~     with those treated with usual-care strategy.~   "
2839|NCT03020394|"~     Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60%~     patients who have severe exacerbation of COPD. Recently, large-scale comparative~     effectiveness research (CER) also found that compared with invasive ventilation, NPPV can~     reduce mortality rates. But there's no high-quality clinical studies which can confirm this.~     Therefore, investigators believe that NPPV can avoid intubation in patients with severe~     exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource~     allocation, in order to reduce IMV-related complications and improve patients' outcomes.~   "
2840|NCT03020381|"~     Motor slowing and cognitive slowing are more prevalent as we age. Importantly, the presence~     of both in an older person increases their risk of having dementia by ten times. Currently,~     there are no clinically meaningful predictors of progression to dementia in people with mild~     cognitive impairment (MCI). The main hypothesis is that subtle variations in gait while~     performing a simple cognitive task is a reliable, easy to perform, and feasible methodology~     to detect those older adults at higher risk of progression to dementia and also, at higher~     risk of further mobility decline and falls.~      Rationale. The Canadian population is aging. According to recent estimates, the proportion~     of the population aged 65 and older will increase rapidly from 13% in 2005 to 25% by 2031.~     This increase in proportion is accompanied by a considerable amount of disability and~     subsequent dependency which has major effects on both the quality of life of older adults~     and their caregivers, and on the Canadian health care system. An important goal of geriatric~     medicine is to reduce the gap between life expectancy and disability-free life expectancy by~     reducing disability and dependency in the later years of life. A substantial portion of this~     disability stems from two major geriatric syndromes: cognitive impairment and mobility~     limitation. The ultimate manifestations of these syndromes are dementia and falls.~     Interestingly, these manifestations often coexist in elderly people: falling is a common~     geriatric syndrome affecting about a third of older adults each year, and dementia affects~     about a third of Canadians aged 80 and over. Together, dementia and falls are responsible~     for much of the discomfort, disability, and health care utilization in older adults and each~     will become more prevalent as older Canadians are expected to number approximately $9~     million by 2031. The combined direct cost of dementia and falls for the Canadian Health~     System is over $4.9 billion per year.~      Establishing reliable and easy to obtain predictors to accurately identify MCI patients at~     highest risk of progressing to dementia is essential first, to determine who will benefit~     from additional and/or invasive testing and second, to implement preventative strategies,~     including cognitive training, physical exercises, and aggressive vascular risk factors~     correction to delay progression. Even a modest one-year delay in dementia incidence could~     save Canada $109 billion over 30 years.~   "
2841|NCT03020368|"~     In this trial we want to prove the efficacy and safety of a one-time topical leech~     application at patients with symptomatic primary arthrosis of the first carpometacarpal~     joint in comparison to the standard therapy with topical diclofenac.~   "
2842|NCT03020355|"~     Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery~     in decreasing the duration, blood loss,and complications of the third stage, against no~     drainage of placental blood.~   "
2843|NCT03020342|"~     Early stage HCC is treated by curative surgical resection or by local ablation (such as~     radio-frequency) as the current standard of care. The complete removal of clinical visible~     HCC is then confirmed by imaging by MRI or CT, or by a decline of tumor marker (AFP or~     PIVKA). However, despite an apparent complete removal of the HCC, those post-curative~     patients frequently develop tumor recurrence at a rate ranging 10-50% within the first year.~     The high rate of early HCC recurrence indicated a minimal residual HCC after the curative~     therapies in a significant proportion of patients. A better and more specific biomarker for~     detecting the residual HCC will improve the patients' prognosis prediction and therapeutic~     plan.~      To detect the minimal residual HCC, a biomarker unique to the tumor is needed. Currently,~     the cell-free circulating DNA carrying tumor-specific somatic mutations has been advocated~     as a promising one. It has been applied to investigate the tumor responses or resistances to~     cancer therapy. However, currently it is restricted to detect or follow only large advanced~     cancer, because of the difficulty in separating or enriching the cfDNA with tumor-specific~     mutations from the cfDNA from normal cells. In this project, the investigators proposed that~     one class of somatic mutation in HBV-related HCC, namely the insertion mutagenesis by~     integrated HBV DNA, could be adopted to circumvent this difficulty. HBV DNA integration has~     been found in the chromosomes of about 90% of HBV-related HCC and the integration site is~     unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a~     tumor-specific biomarker. Such fragments can be released into the circulation as cell-free~     circulating DNAs, and the detection of the HBV-host chimera DNAs in the circulation is a~     reliable evidence for the presence of the tumor in the patient. Therefore the cf circulating~     HBV-host chimera DNA is proposed to assay any minimal residual HCC after curative therapies.~   "
2844|NCT03020329|"~     1. To see the effect if a combination of induction chemotherapy followed by~     chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).~   "
2845|NCT03020316|"~     This study will be a pilot prospective randomized study of using a peer mentor with or~     without transcendental meditation as compared to usual care for women with newly diagnosed~     heart disease (coronary artery disease or CAD). The study is designed to explore the effect~     of these interventions on medication adherence and a number of additional outcomes. The~     results of this pilot study will be used in the design of larger future trials.~      The targeted population is for adult women with a new diagnosis of CAD made on the basis of~     a myocardial infarction or a coronary revascularization procedure requiring inpatient~     hospitalization at the New York-Presbyterian Hospital.~      The overall hypothesis of this proposal is that the addition of a peer mentor to usual care~     will improve self-reported medication adherence for women with newly diagnosed CAD as~     compared with usual care. The further addition of meditation sessions will provide further~     incremental benefit to medication adherence.~   "
2846|NCT03020303|"~     Individuals receiving dialysis are at risk of heart failure and heart related death. There~     is an urgent need for treatments that reduce the risk of these problems in patients that~     require dialysis.~      Spironolactone is a pill used to prevent heart failure and related deaths in patients that~     do not require dialysis. It works by blocking a hormone (aldosterone) in your body that~     causes high blood pressure and can damage the heart. Although spironolactone is very~     effective in patients that do not require dialysis, we do not know if spironolactone is~     effective in dialysis patients. Our research will help determine if spironolactone reduces~     heart failure and heart related deaths in dialysis patients.~      The purpose of this study is to determine if spironolactone reduces death or hospitalization~     for heart failure and is well tolerated in patients that require dialysis.~   "
2847|NCT03020290|"~     Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal~     lesions. This technique tends to extend to lesions for which the gold standard remains until~     now the open surgery treatment (lesions TASC C and D).~      The primary objective of the study was to evaluate the clinical efficacy at 12 months of the~     SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D~     in patients with symptomatic peripheral arterial disease. The secondary objectives are to~     evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical,~     morphological and haemodynamic criteria, the possible influence of calcifications and the~     quality of life of patients.~      The SuperA stent treatment is not specifically provided for by the Protocol but is carried~     out within the framework of the care. This study is an observationnal study.~   "
2848|NCT03020277|"~     This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period~     to explore via a specific Smartphone© application the evolution of a child's behavior over 6~     months and the (psychological and social) effects of these changes on the family.~   "
2849|NCT03020264|"~     Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in~     France.~      Currently the investigators are seeing an aging of the population explained by the increase~     in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the~     frequency of hypoglycemia in older vulnerable patients remains poorly characterized~   "
4671|NCT02996097|"~     The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser~     therapy immediately followed by intralesional steroid therapy against intralesional steroid~     therapy alone for the treatment of keloids.~   "
2851|NCT03020238|"~     Background: Radical hysterectomy is an important therapy for early cervical cancer.~     Disfunction of urinary dynamics is the most common postoperative adverse effects, which had~     negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH)~     could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving~     postoperative urinary dynamics. Furthermore impact of different energy instruments on~     urinary dynamic isn't clear.~      Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze~     the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH,~     Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.~      Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to~     randomly allocated to BiClamp group or water jet group.~      Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.~      Methods: All surgical patients are accessed via urinary dynamics before and four months~     after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual~     urine volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be~     replaced.~      Primary study endpoint: the successful rate of removing urinary catheter on the 14th day~     after NSRH.~      Secondary study endpoint: urinary dynamics four months after NSRH.~   "
2852|NCT03020225|"~     The investigators aim to test the protein bioavailability of new specific developed strain~     of duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein~     source and contains all the 9 essential and the 6 conditional amino acids. The investigators~     will randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods~     items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact,~     cooked (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein~     source). The foods will be consumed in the morning, following 12h fasting. The foods will be~     provided with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary~     outcome: Blood amino acid profile.~   "
2853|NCT03020212|"~     A clinical, prospective, randomized controlled trial to determine the effect of prescribing~     oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen~     tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on~     echocardiogram (which are considered manifestations of chronic hypoxia)~   "
2854|NCT03020199|"~     The purpose of this study is to determine whether early intervention with subcutaneous~     (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may~     lead to prolonged symptom free periods by preventing reactivation of old lesions or~     ultimately totally hindering the occurrence of new lesions, i.e., changing the natural~     course of the disease (Main Study).~   "
2855|NCT03020186|"~     Mediterranean (MED) diet, richer in plants/seeds (and dietary polyphenols) and low in~     processed meat (green-MED diet) may have a pronounced beneficial effect on age-related~     declines that begin in middle age, reflected by changes in adiposity, cognitive function,~     and cardiometabolic risk. The investigators hypothesize that long-term intake of this diet~     will significantly potentiate the effects of a healthy lifestyle (physical activity and~     Mediterranean diet), constituting a powerful strategy to halt or even reverse the~     progression of several age-related processes related to adiposity, cardiometabolic health~     and cognition. The investigators further hypothesize that lifestyle intervention might~     modify the gut microbiota profile and that autologous fecal microbiota supplement derived~     from the time of maximal weight loss might halt the expected subsequent regain phase.~   "
2856|NCT03020173|"~     This study aims to discover the connection between BMI and oocyte and granulosa~     consistencies.~   "
2857|NCT03020160|"~     This multicenter, open-label, non-randomized study will assess the efficacy, safety,~     pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams~     per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without~     inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic~     (PK) run-in part followed by an expansion part.~   "
2858|NCT03020147|"~     The Randomized Control Trail included 4,172 low-birth weight children between February 2008~     and September 2013 in Bissau. The children who were included in the RCT and who are living~     in the Bandim Health Project study area will be visited. The study assistants will ask about~     the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar~     status of both child and parents will be checked.~   "
2859|NCT03020134|"~     The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in~     Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy~     Participants~   "
2860|NCT03020121|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human~     Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media~     diluted in HPV diluent to adjudicated histology results from biopsy.~   "
2861|NCT03020108|"~     The study population will comprise of 90 women age varying between 15-55 years, those are~     candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other~     benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound~     examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis~     of serum biomarkers.~   "
2862|NCT03020095|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir~     (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in~     treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.~   "
2863|NCT03020082|"~     The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08~     (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients~     Who Have Chronic Hepatitis Genotype 1.~   "
2864|NCT03020069|"~     The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)~     with intensive real time feedback about diabetes management from medical staff to the~     patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1~     diabetes. Investigators hypothesize that short-term CGMS use with feedback (and/or lack~     thereof) and patients' sense of self-efficacy~   "
2865|NCT03020056|"~     This is a randomized controlled trial to investigate the effect of cataract surgery on the~     household economy of cataract patients in rural area of Southern China.~   "
13676|NCT02878265|"~     The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and~     multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity~   "
2867|NCT03020030|"~     Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The~     cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced~     in the bone marrow (along with other blood cells) and help fight infections. In ALL, the~     cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd~     out the normal blood cells in the bone marrow so that the body cannot make enough normal~     blood cells. ALL is always fatal if it is not treated. With current treatments, most~     children and adolescents with this disease will be cured.~      The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are~     used, and the doses of the drugs, are similar but not identical for all children and~     adolescents with ALL. Some children and adolescents receive stronger treatment, especially~     during the first several months. A number of factors are used to decide how strong the~     treatment should be to give the best chance for cure. These factors are called risk~     factors. This trial is studying the use of a new, updated set of risk factors to decide how~     strong the treatment will be. The study also will test a new way of dosing a chemotherapy~     drug called pegaspargase (which is part of the standard treatment for ALL) based on checking~     levels of the drug in the blood and adjusting the dose based on the levels.~   "
2868|NCT03020017|"~     The purpose of this research study is to evaluate the safety of NU-0129 SNA gold~     nanoparticle infusion in patients with recurrent glioblastoma multiforme or gliosarcoma.~     This is a first-in-human trial to determine the safety of NU-0129. The study drug is~     composed of a small gold nanoparticle that has spherical nucleic acid attached to it. This~     small particle allows NU-0129 to cross the blood brain barrier (a filtering mechanism that~     carry blood to the brain). Once within the tumor, the nucleic acid component is able to~     target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated~     with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of~     programmed cell death, thus promoting tumor growth. Researchers think that targeting the~     Bcl2L12 gene with NU-0129 will help stop cancer cells from growing.~   "
2869|NCT03020004|"~     The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of~     Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive~     Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.~   "
2870|NCT03019991|"~     The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose~     (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4~     and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.~   "
2871|NCT03019978|"~     The proposed study will include an analysis of data for residents of Pennsylvania who are~     age 21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in~     the Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the~     program will be administered a standardized assessment battery quarterly for two years. The~     proposed study will analyze the data gathered during each of the assessment periods in order~     to aid in service/treatment planning, assess for individual improvements, and ultimately~     measure treatment outcomes.~   "
2872|NCT03019965|"~     This study evaluates the efficacy and safety of the administration of betalactam antibiotics~     in prolonged infusion compared to intermittent infusion in children with sepsis. Half of~     participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or~     extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or~     meropenem in intermittent infusion.~   "
2873|NCT03019952|"~     An analysis of data for adolescents and young adults diagnosed with Autism Spectrum~     Disorders (ASDs) who are evaluated as part of the Care Coordination, Assessment, and~     Responsive Engagement for transition-aged adolescents (t-CARE) program which replaced the~     former Autism Life Care Model (ALCM), which was a clinical program implemented between Fall~     2014 and April 2016. The individuals enrolled in the program will be administered a~     standardized assessment battery during each visit with the care coordinator or study~     coordinator. The proposed study will analyze data gathered during each of the assessment~     periods in order to check the efficacy and viability of the protocol.~   "
2874|NCT03019939|"~     AML/MDS and their treatment may weaken participant's immune system and may make participant~     more likely to develop invasive fungal infections (IFIs).~      The goal of this clinical research study is to learn if isavuconazole can help prevent~     invasive aspergillosis (IA) and other IFIs in patients with AML/MDS. The safety of this drug~     will also be studied.~   "
2875|NCT03019926|"~     A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is~     associated with an increased risk of relapses, hospitalizations, morbidity and poor renal~     prognosis.~      New treatment protocols exist and are indicated in second intention in case of good~     compliance. An assessment of therapeutic adherence is therefore essential.~      Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been~     prescribed with Plaquenil (hydroxychloroquine), will be included in the study.~      The study primary objective is to determine risk factors for non-observance~      The secondary objectives are to:~        -  Measure the observance rate of patients with systemic lupus in Martinique.~        -  Describe the parameters that influence observance: evaluation of the disease and~          associated comorbidities, psychosocial assessment, assessment of the doctor-patient~          relationship, evaluation of the disease representations.~   "
2894|NCT03019328|"~     The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy~     is a major step towards prevention of food allergy. However, because that finding was from a~     clinical trial in a very select population, there are several major questions that must be~     answered in order to implement these findings into clinical practice without causing more~     harm than good. These questions include who, if anyone, should be screened prior to early~     introduction for peanut allergy, how this screening should be done, and what quantity of~     peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer~     these critical questions so that the potential of these recent findings can be realized. To~     that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be~     given a peanut skin prick test, peanut food challenge and have blood drawn for measurement~     of peanut IgE, and then will be followed for assessment of peanut consumption and~     development of peanut allergy until 3 years of age.~   "
4219|NCT03001999|"~     The focus of this study is to examine the feasibility, acceptability, and preliminary impact~     of a customized, combined positive psychology and motivational interviewing (PP-MI) health~     behavior intervention in a group of patients with type 2 diabetes (T2D).~   "
2876|NCT03019913|"~     Muscle wasting is a significant problem in critically ill patients, with reported losses of~     a half to three percent per day over the first ten days (for an average 70kg person this~     equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive~     care unit (ICU) and the loss of lean tissue have been associated with negative clinical~     outcomes, including increased incidence of infections, length of stay, mortality and muscle~     weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients~     with low muscularity on admission, 2) to help understand the factors impacting muscle loss~     and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle~     mass in this population.~      The measurement of lean body mass in patients admitted to the ICU is challenging however,~     due to the large fluid shifts that occur in this population and logistical issues in moving~     patients to specialised machinery for body composition analysis. Currently, there is no~     validated method for accurately assessing a patient's muscle mass at the bedside in the~     intensive care setting. It is therefore important to investigate the accuracy, feasibility~     and reliability of bedside methods such as subjective physical assessment of muscle mass,~     mid arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in~     this population who are primarily bedbound. In order to do this, a critical comparison is~     required between these methods and muscularity assessed by a reference body composition~     method, such computed tomography (CT) image analysis. Briefly, quantification of skeletal~     muscle at the abdomen area utilising abdominal CT images has been shown to be highly~     representative of whole body skeletal muscle volume.~      We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have~     a CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will~     be to investigate whether muscularity assessed with non-invasive bedside methods~     (ultrasound, bioimpedance analysis, SGA physical assessment, mid arm muscle circumference)~     are correlated with skeletal muscle mass quantified by a reference method (CT image~     analysis).~   "
2877|NCT03019900|"~     The purpose of this study is to describe current practice on red blood cell transfusion in~     critically ill patients of intensive care units located in high altitude areas~   "
2878|NCT03019887|"~     To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than~     1000mg/day and to evaluate relationship between relapse and cognitive function.~   "
2879|NCT03019874|"~     The main focus of this observational study is to analyze the possible effects of cranberry~     dietary supplements on the intestinal microbiota in women with recurrent uncomplicated~     urinary tract infections. In a secondary analysis the possible influence of the microbiota~     changes on the recurrence frequency in the follow-up should be analyzed.~   "
2880|NCT03019861|"~     The main goal of this randomized, controlled clinical pilot study is to evaluate the~     efficacy of an individual Ayurvedic nutritional counseling (according to tradition) compared~     to an individual conventional dietary advice (according to the German Nutrition Society -~     DGE) in patients with irritable bowel syndrome. It is to be investigated whether nutritional~     therapy elements, which patients can self-implement independently in the home environment,~     can achieve sustainable therapy effects.~   "
2881|NCT03019510|"~     Morning hyperglycemia plays a role in the future development of insulin resistance and type~     2 diabetes (T2D) (8) and is associated with numerous microvascular and cardiovascular~     complications and renal disease. These augmented morning glucose levels are due to an~     elevated endogenous glucose production (EGP), as a result of a loss of coordination between~     glucose levels and insulin secretion, and possibly hyperglucagonemia during the overnight~     period. Exercise stimulates glucose uptake and increases insulin sensitivity acutely, and~     may be the best lifestyle intervention to minimize the nocturnal rise in glucose levels.~     Prescription of the timing of exercise relative to a meal and/or to the overnight period may~     be particularly critical for individuals that have impaired fasting glucose (IFG) levels.~     Surprisingly little is known about the overnight period when elevated EGP and the synchrony~     between glucose and c-peptide/glucagon levels becomes disturbed. This novel study will~     provide insight into the hormonal/metabolic milieu of a dinner meal, the evening and~     overnight period that occurs in non-obese, OB and OB+IFG individuals; it will also establish~     if the timing of exercise can attenuate nocturnal glucose elevations, and if this is~     associated with improved hormonal synchrony. This project will compare EGP, β-cell function~     and hormonal responses between morning and evening exercise on the postprandial and~     overnight period in obese individuals with/without IFG levels. Fifty-four subjects will be~     studied during the evening meal (EGP and β-cell function), postprandially and through the~     overnight period (1600-0700 h), allowing us to examine some of the potential mechanisms for~     the elevation in overnight glucose levels. This is the first study that will examine this~     issue from pre-dinner through the night while previous studies have only examined~     chronically fasted individuals and this study will lay the groundwork for understanding the~     pathology of the predawn phenomena in OB+IFG individuals. These potentially translational~     findings may impact the efficiency of physician communication to patients concerning~     exercise. These investigators are one of the few groups that study subjects through the~     overnight period and have the facilities and capability to do this research.~   "
2882|NCT03019497|"~     The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral~     therapy (CBT) in a population of individuals with PTSD and common related problems~     (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support,~     substance use disorder). Half of the participants will receive a cognitive behavioral~     therapy with specific modules for the treatment of related problems (CBT-E) and the other~     half of participants will receive therapy without specific modules (CBT-C).~      The main assumption is that participants treated in the CBT-E condition will present a lower~     level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C~     condition during the post-treatment assessment. As a secondary objective, an analysis of the~     different parameters of effectiveness of the two forms of CBT (e.g., average number of~     sessions required to reach remission, treatment strategies used) will be performed.~   "
2883|NCT03019484|"~     The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy~     promotion intervention. More specifically our objectives were to: explore changes in~     self-efficacy following the intervention; explore changes in the initiation and maintenance~     of breastfeeding following the intervention.~   "
2884|NCT03019471|"~     The investigators aim to collect tumor DNA out of blood of cancer patients. If this is~     successful this could lead to the development of a cancer test in blood in the future, which~     is less invasive than current diagnostic methods.~   "
2885|NCT03019458|"~     To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen~     among X-linked Dystonia Parkinsonism patients.~   "
2886|NCT03019432|"~     In this study, the researchers will investigate whether the E-effect is present in stroke~     subjects both on the subjective visual and postural vertical test. In addition, researchers~     will investigate the impact of the loss of different sensory information sources on the~     sensory reweighting strategies and perception of verticality by measuring the effect of~     somatosensory loss on the E-effect.~   "
2887|NCT03019419|"~     To investigate the safety and the efficacy of perampanel in patients with sporadic~     amyotrophic lateral sclerosis~   "
2888|NCT03019406|"~     Primary Objective:~      To evaluate the safety profile of neoGAA in patients with infantile-onset Pompe disease~     (IOPD) previously treated with alglucosidase alfa.~      Secondary Objective:~      To characterize the pharmacokinetic profile of neoGAA and to evaluate the preliminary~     efficacy of neoGAA in comparison to alglucosidase alfa.~   "
2889|NCT03019393|"~     This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin~     bound iron (NTBI)~   "
20224|NCT02792478|"~     Analysis of freely circulating DNA in liquid biopsies using the BEAMing method~   "
2899|NCT03019263|"~     Menopause is usually associated with an increase in body weight, a change in body~     composition and fat distribution and a large number of cardio-metabolic changes, such as~     hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy~     for these complications is the modification of dietary habits and lifestyle in terms of~     physical activity. Besides, there is also a growing interest in complementary therapies~     (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent~     results. In this context, preliminary evidence supports the potential role of some compounds~     of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support~     of their use, the evidence from good quality trials is limited.~   "
2900|NCT03019250|"~     Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty~     acids, selenium, and antioxidants has been suggested to reduce infections and improve~     recovery from critical illness. However, the effects of colostrum on clinical outcomes in~     critical ill patients has not been investigated. In current trial, intensive care unit~     patients with enteral feeding will receive either enteral colostrum or maltodextrin as~     placebo.~   "
2901|NCT03019237|"~     In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or~     intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before~     nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,~     specific and total IgE levels will be assessed.~   "
2902|NCT03019224|"~     Introduction: The pain sensitivity associated with whitening is the main problem reported by~     patients during dental whitening, and the use of desensitizing dentifrices is an alternative~     for the treatment of sensitivity.~      Objective: To evaluate clinically the influence of desensitizing dentifrices applied through~     a plastic tray, reducing the pain sensitivity and color variation caused by the technique of~     in-office dental whitening, through a controlled double-blind clinical study.~      Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30~     years of age, without gender distinction, who underwent in-office dental whitening using 35%~     hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions~     with a one-week interval between them. The volunteers used in the night for each bleaching~     session a plastic tray for 4 hours containing one of the dentifrices related to the~     experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy);~     Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple,~     Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with~     1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium~     nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel,~     GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the~     plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after~     the tray), in the second session (S3: sensitivity before the tray, S4: in the third session~     (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical~     scale with scores from 0 to 10 and for the color evaluation the spectrophotometer~     (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The~     data were submitted to the multivariate analysis of variance (MANOVA) with repeated~     measurements and Lambda Wilks test with a 5% probability level to differentiate the groups.~     In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of~     p <0.05 were considered statistically significant.~   "
2903|NCT03019211|"~     This is a pilot randomized control trial with single blinding of the assessor that will be~     conducted in two nursing homes residence to evaluate the applicability of a physical~     exercise program performed in an aquatic environment compared with the same realization but~     land-based to reduce falls in the institutionalized old people. The secondary objectives are~     to study the applicability of the intervention in improving balance, function, gait~     mobility, muscle strength of the lower limbs and the perception of the intervention.~   "
2904|NCT03019198|"~     This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients~     undergoing total hip arthroplasty (THA).~   "
2905|NCT03019185|"~     This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and~     efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2~     portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of~     the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180~     patients.~   "
2906|NCT03019172|"~     RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus~     reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure~     in women with non complicated acute cystitis who receive probiotics for 12 days compared~     with the frequency in women who receive placebo.~   "
2907|NCT03019159|"~     The objective of the study is to determine whether tele-consulting for the follow up of~     patients with renal failure under peritoneal dialysis would not increase the risk of~     experiencing a severe adverse event~   "
2908|NCT03019146|"~     The incidence of conditions requiring surgical intervention increases with age, however~     there is a reported decline in the rates of elective surgical procedures in those over 65.~     This is associated with older patients being described as less fit and more at risk of~     postoperative complications, leading to decreased provision of surgical care to those at~     need. Exercise interventions have the potential to reverse some of the decline in~     cardiovascular fitness associated with aging and improve the elderly's' fitness for~     surgery and potentially allow increased access to surgical care for those most in need of~     it.~   "
2909|NCT03019133|"~     The goal of the project is to determine the effects of noise masking and noise reduction on~     stress related physiological parameters in critically ill patients admitted to the intensive~     care unit.~   "
2910|NCT03019120|"~     This study will evaluate the effect of vitamin D supplementation on the neurocognitive~     function of older people with lower than normal levels of vitamin D at baseline~   "
2911|NCT03019094|"~     Interventional, Prospective, Open Label study~   "
2912|NCT03019081|"~     The researchers propose to utilize a pharmacological approach involving infusions of the~     sympathomimetic agent isoproterenol to repeatedly trigger cardiorespiratory sensations and~     anxiety during meal anticipation, to facilitate the development of tolerance or a reduction~     of the anxiety/fear response in individuals with anorexia nervosa. The investigators aim to~     conduct a proof of principle study to assess for evidence of initial efficacy of this new~     treatment approach. As a comparator condition, the researchers propose using repeated~     administration of saline infusions.~   "
2939|NCT03018730|"~     This is an open label switch over study to assess the safety and efficacy of PRX-102.~     Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80%~     labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3~     months while continuing on agalsidase alfa. Following the screening period, the patient will~     be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV)~     infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated~     patients will be female.~   "
2913|NCT03019068|"~     This retrospective study aims to assess, on a large number of clinical trials (CT), the~     usefulness of converting CT eligibility criteria into standardized queries performed on~     commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate~     the potential recruitment of clinical trials centers.~      Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against~     thorough examination of patient files.~      Primary objective is to estimate the precision of the prediction system, i.e. ratio of~     numbers of eligible patient files / numbers of candidate patient files.~      As secondary objectives, the study aims:~        -  to measure the recall rate or sensitivity of the system: ratio of number of candidates~          patient files / number of recruited patients;~        -  to measure the ability of coding: proportion of codable criteria (inclusion criteria or~          non inclusion criteria) into normalized language;~        -  to mesure the time required for coding criteria and the time required to execute the~          queries on the national DRG database;~        -  to evaluate the reliability of coding process by an independent coding of a random~          sample of 30 protocols;~        -  to analyse influence of characteristics of the clinical study (design, disease, ...)~          and of the investigation site (volume, teaching status, ...) on the precision and~          sensitivity of the prediction system.~   "
2914|NCT03019055|"~     This is a phase 1, interventional single arm, open label, treatment study designed to~     evaluate the safety and feasibility of infusion of autologous T cells engineered to contain~     an anti-CD19 and anti-CD20 scFv coupled to CD3ζ and 4-1BB signaling domains in patients with~     relapsed and/or refractory CD19 or CD20 positive B cell malignancies~   "
2915|NCT03019042|"~     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving~     symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal~     disorder.~   "
2916|NCT03019029|"~     The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir~     PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with~     pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare~     these results to non-amyloid diseased controls.~   "
2917|NCT03019016|"~     The primary objective of this study is to retrospectively compare the perioperative and~     short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal~     anastomosis in minimally invasive right colectomies for benign and malignant disease.~      The secondary objective of this study is to retrospectively compare the rates of incisional~     hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.~   "
2918|NCT03019003|"~     This is a non-randomized, open-label, Phase Ib/II study to assess the safety and efficacy of~     azacitidine, durvalumab (MEDI4736), and tremelimumab combination therapy in the treatment of~     patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck~     (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or~     anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is~     studying drugs that can boost the participant's immune system against the cancer cells as a~     possible treatment for head and neck cancer.~      The study interventions involved in this study are:~        -  Azacitidine (Vidaza)~        -  Durvalumab (MEDI4736)~        -  Tremelimumab~   "
2919|NCT03018990|"~     To investigate the effects of acute alcohol challenge on the gut and liver axis.~   "
2920|NCT03018977|"~     Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic~     effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use~     of the agents can lead to withdrawal symptoms when the drugs are weaned.~      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and~     younger age were the risk factors of withdrawal syndrome. Additional, some study showed the~     sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide~     standardized sedative weaning protocol including our hospital. The objectives in this study~     are to establish the sedative weaning protocol and to compare the protocol sedative weaning~     with the usual care weaning.~   "
2921|NCT03018964|"~     The purpose of this study is to determine safety of solo surgery in single incision~     laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator~     assisted SILC~   "
2922|NCT03018951|"~     The purpose of this study is the development of, and two stages of pilot testing of, a tool~     designed to assess frailty in older adults with a diagnosis of a functional mental illness.~     During the tool's development stage, participants' input, ideas and feedback will be sought~     to inform the tool's design. In the first pilot test the comprehensibility, acceptability~     and feasibility of the tool will be established. The tool will be amended based on~     information gained in the first pilot test. In the second pilot test the comprehensibility,~     acceptability and feasibility of the revised tool will be established. Reliability of the~     tool will be explored and preliminary examinations of both the interpretability and~     construct validity of the tool will be completed.~   "
2923|NCT03018938|"~     The purpose of this study is to compare the effectiveness of basal insulin analog and~     insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.~   "
2924|NCT03018925|"~     This study aims to characterize the changes on intestinal microbiota pattern associated with~     the use of golimumab in order to determine if intestinal microbiota markers may correlate~     with golimumab therapeutic effect in patients naïve & non-naïve to anti-TNF treatment~   "
2925|NCT03018912|"~     Sleep disorders are commonly under-recognized in the primary care setting and available~     screening tools are often are limited. The study inestigators hypothesize that the use of a~     novel subjective sleep vital sign (VS) will improve recognition of patients with sleep~     disorders and can be utilized to track outcomes to sleep therapy.~   "
2926|NCT03018899|"~     This prospective, randomized study is aimed to assess the efficacy and safety of~     paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The~     investigators suppose that paravertebral block is not inferior in controlling the~     perioperative pain for percutaneous nephrolithotomy compared to epidural block.~   "
2927|NCT03018886|"~     The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus~     arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth~     hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against~     the IS 98/574 from the World Health Organization. A specific aim was to study the effect of~     gender and age on the peak GH response in the GHRH+arg test~   "
2928|NCT03018873|"~     Patients with acute myocardial infarction (AMI) are in critical condition. When primary~     percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart~     failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic~     preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will~     investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients~     short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were~     randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once~     RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group~     (without RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP),~     adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1),~     echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after~     PCI. Patients will be followed up by telephone at the end of one year. The major adverse~     cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial~     infarction, unplanned revascularization and stroke.~   "
2929|NCT03018860|"~     Active phase of the second stage of labor corresponds to period of maternal expulsive~     efforts (i.e. pushing). An intensive management of this phase is usual in France. This study~     aims to evaluate the impact of an alternative moderate management during this pushing~     phase on neonatal and maternal issues and mode of delivery.~   "
2930|NCT03018847|"~     The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD~     disease management program manufactured and operated by HGE Health Care Solutions, LLC, in~     COPD patients outside of the geographic base of HGE's existing patient population~     (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program~     to additional geographic sites and to examine whether similar outcome measures are achieved~     in patients under the supervision of health care providers that are new to the program.~   "
2931|NCT03018834|"~     There is no specific treatment of acute myocarditis, especially during the inflammatory~     period. Interleukin (IL) is specifically involved during this period and play a role in~     myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been~     evaluated in myocarditis. The benefit for the patient could be important with a reduction of~     heart failure and ventricular arrhythmias.~      Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is~     superior to standard therapy based on an association of beta-blockers and~     Angiotensin-Converting-Enzyme inhibitor (ACE).~   "
2932|NCT03018821|"~     Although the incidence of Hepatitis B has been decreased a lot recently years, there are~     still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western~     medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum~     hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on~     TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and~     abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate~     treatment of TCM. This study is a multicenter, randomized, open label, parallel group~     clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM)~     herbal treatment on chronic hepatitis B.~   "
2933|NCT03018808|"~     Early diagnosis and appropriate treatment for COPD patients are both critical to minimize~     the progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil~     (specific type of white blood cell that protects body against certain kinds of germs) level~     is associated with increased risk of both moderate and severe exacerbations in COPD~     patients. To date, there is insufficient amount of data that describes the prevalence of~     COPD in Brazilian primary care units. Thus, this multicenter, cross-sectional study~     conducted in five centers located in five different Brazilian cities will provide estimation~     about the prevalence of COPD in primary care and will also determine the levels of~     eosinophils in subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects~     are expected to be enrolled in the study.~   "
2934|NCT03018795|"~     Decontamination procedure is a challenging factor that affects the success of surgical~     regenerative therapy (SRT) of peri-implantitis. The purpose of the present study was to~     determine the impact of additional ozone therapy for the decontamination of implant surfaces~     in SRT of peri-implantitis. A total of 21 patients with moderate or advanced~     peri-implantitis were randomly allocated to the test group (ozone group) with the use of~     sterile saline with additional ozone therapy or the control group with sterile saline alone~     for decontamination of the implant surfaces in SRT of peri-implantitis. Clinical and~     radiographic outcomes were evaluated at baseline and 6 months postoperatively~   "
2935|NCT03018782|"~     The investigators are evaluating refugee torture survivors who are receiving services at the~     Weill Cornell Center for Human Rights. There are two research questions in this study: if~     the current standard of care results in the under or missed diagnosis of pain and pain~     syndromes, and if a validated pain screening tool can supplement the current standard~     protocol used in the assessments of survivors of torture.~   "
2936|NCT03018769|"~     1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize~     the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.~      1.3 To formulate a syndrome differentiation determined medicine plan based on the~     improvement in the quality of life on chronic stable CAD patients.~   "
2937|NCT03018756|"~     Patients with idiopathic pulmonary fibrosis (IPF) experience distressing activity-related~     respiratory discomfort which is challenging to manage therapeutically. Interventions such as~     pulmonary rehabilitation, collaborative self-management, supplemental oxygen therapy and~     oral opiate medications, are variably effective and therapeutic responses to each in~     individual patients are difficult to predict. The purpose of this study is to evaluate the~     acute effects of inhaled opiate therapy (fentanyl citrate) on breathing discomfort (dyspnea)~     in individuals with mild-to-moderate IPF, as well as examine the potential mechanisms of~     dyspnea relief.~   "
2938|NCT03018743|"~     Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.~      Until now dapoxetine is the only approved medical treatment option and there is no second~     line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of~     the factors that lead to dropout is needed especially in a real-practice setting.~      With this background, investigators are going to assesse the discontinuation rate of~     dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical~     setting throughout a follow-up period of 2 years.~   "
2940|NCT03018717|"~     Information and communications technologies (ICT) currently constitute a key element in the~     innovation and improvement of providing health-care to frail populations with advanced~     chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven~     conclusively. The investigators are going to carry out a multi-center, randomized, parallel~     groups, phase III clinical trial in adult patient with heart and/or lung advanced~     diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of~     bio-parameters added to optimal standard of clinical care (shared clinical care plan)~     compared to the shared clinical care plan exclusively.~   "
2941|NCT03018704|"~     The focus of this application is on the improvement of services for African American (AAs)~     Veterans afflicted with an alcohol use disorder. The project focuses on the use of~     topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy~     drinking than European Americans (EAs), AAs have significantly higher rates of mortality~     from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and~     violence. Despite the higher rates of morbidity and mortality, pharmacological treatments~     are understudied in this population and there is some evidence that medications are less~     preferred and less effective in AAs.~   "
2942|NCT03018691|"~     To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1%~     OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.~   "
2943|NCT03018678|"~     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder~     characterized by markedly elevated LDL-cholesterol (LDL-C) levels, resulting in severe~     atherosclerosis often leading to early onset of cardiovascular disease. The most frequent~     cause is mutation in the LDL receptor gene (LDLR). LDL-C levels remain frequently above~     acceptable levels despite treatment with multiple existing lipid lowering drugs and/or LDL~     apheresis. Thus, the functional replacement of the defective LDLR via AAV-based~     liver-directed gene therapy may be a viable approach to treat this disease and improve~     response to current lipid-lowering treatments. The purpose of this protocol is to identify~     and screen potential candidates for future enrollment in a gene therapy clinical trial. No~     study drug will be administered in this screening study.~   "
2944|NCT03018665|"~     The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing~     diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese~   "
2945|NCT03018652|"~     Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease of the~     airways, associated with poor health status, functional disability, significant morbidity,~     and increased risk of death. In Ontario, COPD is the leading cause of hospital admission and~     readmission, and costs the health system approximately 3 billion dollars annually.~     Individuals with COPD experience increased 'flare-up's' (acute exacerbations) as their~     disease worsens, characterized by periods of increased shortness of breath, cough, phlegm~     production, and weakness. Acute exacerbations of COPD (AECOPD) are most commonly caused by~     viral or bacterial infections, and often require patients to seek attention at the emergency~     room or hospital for treatment. Current treatments to prevent COPD exacerbations are only~     modestly effective. New therapies are needed to improve the quality of life and clinical~     outcomes for individuals living with COPD.~      Previous research at our center has shown a favourable effect of an antibody treatment~     (immunoglobulin) on the frequency of AECOPD, doctor visits, treatments, and hospitalizations~     for COPD patients. However, rigorous studies with more patients are required to confirm this~     effect.~      The investigators propose a clinical trial to evaluate immunoglobulin treatment in~     outpatients with frequent exacerbations. In this study the investigators will determine if~     immunoglobulin treatment is feasible, safe, tolerable, and potentially effective in reducing~     the frequency of acute exacerbations. If this study is feasible and potentially effective,~     it will inform larger studies to confirm the therapeutic effect of immunoglobulin treatment,~     and would be a major advance in care of COPD.~   "
2946|NCT03018639|"~     Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient~     Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set~     assessing demographic information and pretreatment psychopathology during the days of their~     inpatient stay. Beyond that, changes of therapists were documented.~   "
2947|NCT03018626|"~     This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of~     R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse~     large B-cell lymphoma~   "
2948|NCT03018613|"~     Chronic functional constipation is a common digestive system disease, the incidence is~     increasing in recent years.It is reported that the occurrence and development of chronic~     functional constipation is closely related to imbalance of intestinal flora .Moreover,types~     and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota~     transplantation as a new technology to rebuild intestinal flora has been used for several~     disease，but the clinical efficacy of chronic functional constipation by fecal microbiota~     transplantation needs to be further explored.~   "
2949|NCT03018600|"~     Glucocorticoid is widely used in clinical treatment. Recently, there was research about~     glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with~     active autoimmune diseases. Through this prospective trial, the investigators wanted to know~     the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone~     or equivalent) in young patients (30-40 years) with active autoimmune diseases with or~     without low-dose glucocorticoid maintenance. The investigators used continuous glucose~     monitoring for 72 hours to get a better understanding of the glucose levels.~   "
2950|NCT03018587|"~     A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency~     device.~   "
2971|NCT03018314|"~     The study population is comprise of 90 women those age varies between 18-38 year-old. The~     first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the~     second group will comprise of 30 women with diagnosis of unexplained infertility and the~     third group will comprise of 30 women those partners with male subfertility. A 2 cc blood~     sample for Kisspeptin analysis will be drawn from the antecubital vein from each~     participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the~     menstrual period and follicular development will be measured with serial ultrasound follow~     up.~   "
2972|NCT03018301|"~     The purpose of this study is to investigate the analgesic effect of low-dose intravenous~     ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal~     anesthesia.~   "
2951|NCT03018574|"~     Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow~     University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD~     and age, sex matched healthy controls; Case exclusion criteria: all kinds of~     neuropsychiatric disorders, IQ value of less than 70;~      Study protocol:~        1. Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.~        2. UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the~          concentration of 100ng/μL or more before the next sequencing.~        3. The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company~          (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence.~          According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene,~          https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9?~          Report=genbank&from=21016763&to=21070872&strand=true) (a total of 17 exons and 16~          introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find~          potential mutations.~        4. Using the chi square analysis and other statistical methods to determine the~          relationship between the mutations and susceptibility to ADHD.~   "
2952|NCT03018561|"~     People with cardiovascular risk (CV) factors (obesity, diabetes, etc...) or established~     heart disease (such as coronary heart disease or chronic heart failure) often have cognitive~     dysfunction as compared to people without CV risk factors or heart disease. Among the~     mechanisms, a reduced cardiac output and cerebral blood flow in those people have been~     suggested. The aim of this study was to compare resting cognitive function, maximal~     cardiopulmonary function, cardiac output and cerebral hemodynamics during exercise in~     patients with metabolic syndrome, coronary heart disease, or heart failure vs. healthy~     subjects.~   "
2953|NCT03018548|"~     To monitor changes in indicators of red cell damage such as extracellular hemoglobin,~     potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.~   "
2954|NCT03018535|"~     Idiopathic Membranous nephropathy (IMN) is an auto-immune glomerular disease. Recent studies~     suggest that circulating auto-antibodies against the podocyte surface antigens phospholipase~     A2 receptor1 (PLA2R1) and thrombospondin type 1 domain-containing 7A (THSD7A) cause the~     disease in the majority of the patients. Additional autoantibodies, directed to podocyte~     neo-expressed cytoplasm proteins have been described, including aldose reductase (AR),~     Mn-superoxide dismutase (SOD2) and alpha-enolase (alpha-ENO).~      The commonest presentation of IMN is nephrotic syndrome. Data from placebo arms of~     interventional studies show that 30-40% of the untreated patients with persistent nephrotic~     syndrome (NS) progress to end-stage renal disease (ESRD).~      The best-validated treatment regimen of IMN is combination therapy with steroids and~     cyclophosphamide, capable to induce remission of protenuria in two-third of the patients.~      Despite this evidence of efficacy, there are concerns about the use of cyclophosphamide,~     since it may be associated with adverse events, including bone marrow suppression, gonadal~     toxicity, infections and oncogenic effects. Thus, the availability of alternative therapies~     highly effective but with a greater safety profile is desirable.~      Given the key role of IgG antibodies in IMN, B cell depletion may favourably impact the~     glomerular disease. The anti-CD20 monoclonal antibody Rituximab is a selective B cell~     depleting agent. There is evidence that Rituximab is effective in the treatment of other~     diseases in which B cells play a key role, such as ANCA-related vasculitis. Observational~     studies in IMN provided encouraging data; in addition, the drug seems well tolerated.~      Head-to-head comparisons between Rituximab and steroid plus ciclophosphamide in randomized~     clinical trials are missing.~      The investigators propose this study in order to test, in a randomized controlled trial, the~     hypothesis that Rituximab is more effective than cyclical steroid/alkylating-agent therapy~     in inducing remission in patients with IMN and NS undergoing the initial treatment. In~     addition, the levels of the above-mentioned pathogenetic autoantibodies will be measured at~     baseline and during treatment. Finally, the study will compare the safety profile of steroid~     plus cyclophosphamide and Rituximab by evaluating the rate and severity of adverse events~   "
2955|NCT03018522|"~     Primary aim of this study is to evaluate the association between postoperative cognitive~     dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic~     radical prostatectomy.~   "
2956|NCT03018509|"~     Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of~     JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.~   "
2957|NCT03018496|"~     This study intends to examine the effect of a commercially available nutritional supplement,~     Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.~   "
2958|NCT03018483|"~     The aim of this multicenter, randomized controlled trial is to evaluate the weaning time~     from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.~      This study is a multicenter randomized controlled open trial comparing variable,~     non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical~     ventilation for more than 24 hours who are able to be weaned.~      The aim of the study is to determine the duration of weaning from mechanical ventilation for~     each one of the above mentioned weaning methods~   "
2959|NCT03018470|"~     Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients.~     Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that~     have to be monitored are not well defined.~      Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in~     software which are recording the breathing pattern of patients when used. The aim of this~     study is to identify ventilation parameters that are modified at the early stage of an~     AECOPD.~   "
2960|NCT03018457|"~     Dental implants are a prosthetic rehabilitation device whose success depends of the bone~     morphology and quality, in more the surgical procedure.~      This study aims to assess whether the parameters of the trabecular microarchitecture of~     alveolar bone taken from the site of the placement of the dental implant, calculated by~     micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according~     the principle of the resonance frequency analysis at the 10th postoperative week during the~     osseointegration of dental implants (secondary stability).~      The cortical alveolar bone is a recognized factor in the phase of primary stability of~     osseointegration. The role of trabecular bone in the secondary stability is not clearly~     determined.~   "
2961|NCT03018444|"~     The primary objective of the present study is to evaluate the effect of HMG-CoA reductase~     inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.~     Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial~     glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile~     acids and pancreatic and enteric hormones known to influence glucose metabolism and~     appetite, and faecal content of bile acids and gut microbiota composition.~   "
2984|NCT03018145|"~     To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car~     for reducing preoperative children's anxiety.~   "
4868|NCT02993510|"~     The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®~     collagen membrane either sutured or glued compared to microfracture alone in the treatment~     of symptomatic cartilage defects of the knee.~   "
2962|NCT03018431|"~     We aim to show that systematic ultrasonography performed in ventilated patients suspected of~     ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and~     helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is~     considered.~      Chest CT scan is often performed before or just after admission in ICU, and usually show~     abnormalities that are revealed later on standard radiographs.~      This last exam is traditionally considered as the gold standard to prove new pulmonary~     infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to~     over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered~     prescription of antibiotic therapy.~      Lung ultrasonography conducted systematically within the 3 first days after suspcion of~     pneumonia could help making the difference between real infection-linked lesions, and banal~     abnormalities following the hydric inflation of intra-thoracic organs, for instance~     pulmonary edema or pleural effusion.~      An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when~     performed, compared with the physician in charge of the patient appreciation by suggesting~     him to provide his own probability of pneumonia upon routine clinical and biological datas.~   "
2963|NCT03018418|"~     The purpose of this research study is to determine whether the amount of radiation given to~     the normal areas around the anal cancer can be reduced by using Proton Therapy while~     reducing the side effects that are seen with standard therapy.~   "
2964|NCT03018405|"~     THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I~     study to assess the safety and clinical activity of multiple administrations of autologous~     NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian,~     bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute~     myeloid leukemia and multiple myeloma).~      The trial will test three dose levels. At each dose, the patients will receive three~     successive administrations, two weeks apart, NKR-2 cells. The dose escalation part of the~     study will enroll up to 24 patients while the extension phase would enroll 86 additional~     patients.~   "
2965|NCT03018392|"~     The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of~     20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody~     Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market~     outcomes study to build on the body of long-term evidence for the device.~   "
2966|NCT03018379|"~     Considering the increasing public health concern the obesity in Morocco, the aim of the~     present study was to use isotope techniques to assess body fat, total energy expenditure and~     physical activity to inform design and improve interventions for the prevention and control~     of obesity and related health risks such as diabetes and elevated blood pressure among~     children and adolescents. Specific objectives of the trial: 1. Determine the extent of~     obesity and physical activity levels in children and adolescents to design effective~     interventions in the school setting. 2.Propose alternative field based techniques for~     assessing body composition and physical activity that could be used in largescale situation~     assessments and in assessing interventions to address obesity and risk related health care.~     * For body composition: BMI z-score, waist circumference, waist measurement at height. * For~     physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the~     development of obesity and related health risks in schoolchildren and adolescents. 4.~     Collaborate with stakeholders (government, schools and / or colleges, communities and~     development partners) in designing interventions to address obesity and health risks. 5. To~     recommend to stakeholders the most effective interventions in schools to prevent and combat~     obesity and health risks in children and adolescents.~   "
2967|NCT03018366|"~     The purpose of this study is to determine whether low estrogen levels in young women with~     hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for~     cardiovascular disease.~      For this study, the investigators will measuring vascular function and immune markers on:~        -  young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low~          estrogen)~        -  young women with regular menstrual cycles not on hormone therapy.~        -  recently menopausal women (<3 years from final menstrual period) not on hormone~          therapy.~      Premenopausal HypoE participants will then be randomized to use either an estrogen patch or~     a placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch~     plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to~     see if estrogen improves vascular and immune function.~   "
2968|NCT03018353|"~     Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will~     assess the feasibility of a HCV treatment program in the San Francisco City & County Jail.~     The Jail Health Services will treat 100 patients using the FDA approved combination~     treatment, sofosbuvir/velpatasvir, Eplcusa® and will continue their treatment during~     incarceration and after their release (if applicable).~   "
2969|NCT03018340|"~     To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a~     selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor~     (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an~     inadequate response to antidepressant therapy~   "
2970|NCT03018327|"~     Transplant-related malignancies have emerged as one of the important complications after~     organ transplantation. Some studies have shown that transplant recipients have an increased~     risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic~     immunosuppression in these patients, there is an increasing focus on human papillomavirus~     (HPV) related cancers.~      The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among~     Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies~     exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical~     precancerous lesions among RTRs.~      Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal~     transplant recipients, together with identification of factors that play a role for~     development of anal and cervical precancerous lesions, is important for the possibility of~     early detection and treatment to prevent progression to ano-genital cancers. Cervical~     cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN),~     whereas high-resolution anoscopy is a newer modality for the detection of anal~     intra-epithelial neoplasia (AIN). International guidelines recommend annually screening~     against cervical cancer for female renal transplant recipients, but currently no~     recommendation exists on screening against anal cancer.~      Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and~     cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250~     renal transplant recipients and an immunocompetent control group. Furthermore to identify~     factors associated with the development of AIN or CIN such as HPV type, viral load, duration~     of immunosuppression, and lifestyle factors such as sexual habits, reproductive history,~     smoking and alcohol habits, history of genital warts and other infections, and~     socio-economic variables.~   "
5005|NCT02991729|"~     The investigators aim to assess whether use of a novel, tablet-based computerized decision~     aid for aneuploidy screening is similar to routine care with a brief genetic counseling~     visit in improving patient knowledge and decreasing decisional conflict.~   "
2973|NCT03018288|"~     Background:~      GBM refers to a specific kind of brain cancer called glioblastoma. The standard treatment~     for GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an~     immune therapy that is now used to treat other cancers. The addition of pembrolizumab to the~     standard treatment of radiation and temozolomide has been shown to be well tolerated..~     Researchers want to see if adding a vaccine made from the person s own tumor will improve~     the effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at~     the time of surgery is called HSPPC-96.~      Objectives:~      To see if the adding pembrolizumab and HSPPC-96 improves the standard treatment for~     glioblastoma multiforme.~      Eligibility:~      Adults at least 18 years old with glioblastoma.~      Design:~      Participants will be screened with typical cancer tests:~      Brain scan~      Medical history~      Blood and urine tests~      Questions about quality of life and symptoms~      These tests will be repeated throughout the study.~      Participants will have surgery to remove their tumor. A tissue sample from the tumor will be~     sent to a lab. A vaccine will be made from it.~      Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and~     placebo. Participants will not know which they get.~      Participants will get radiation for 6 weeks.~      Participants will take temozolomide by mouth before each treatment.~      Participants will get pembrolizumab by IV for 30 minutes 3 times over the radiation cycle.~      Participants will keep taking the 2 drugs every few weeks for about a year. Some may take~     pembrolizumab for an additional year.~      Most participants will get the vaccine or placebo after radiation. They will get it 5 times~     over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2~     years.~      Participants will repeat the screening tests when they stop study treatment. They will also~     have follow-up phone calls.~   "
2974|NCT03018275|"~     Background:~      Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and~     sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye~     infections, and sleep problems. The cause of AD might be related to bacteria that live on~     the skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto~     the skin of someone with AD helps treat the disease.~      Objective:~      To test the safety and activity of R mucosa for treating AD.~      Eligibility:~      Part 1: People ages 18 and older with AD~      Part 2: Children ages 7 17 with AD~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Examination of their AD~      Blood and urine tests~      At the baseline visit, participants will have blood tests and photos taken of their skin.~     They will get a supply of R mucosa and a memory aid to track their doses and record how they~     are feeling. Part 2 participants guardians will complete questionnaires about their child s~     AD.~      Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks.~      Part 2 guardians will spray it on their child s arm twice per week for 16 weeks.~      Participants will have follow-up visits to repeat some baseline tests and review their~     memory aid:~      Part 1: Six weeks after the baseline visit~      Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year~      Participants will be called or emailed to discuss how they are feeling:~      Part 1: About 30 days after their last visit~      Part 2: About every 10 days between visits~   "
2975|NCT03018262|"~     Background:~      Movement disorders have many different causes and symptoms. Researchers still do not fully~     understand which parts of the brain are involved in fine movement. They want to learn about~     which brain regions could be abnormal in people with movement disorders.~      Objective:~      To better understand how the brain controls movement.~      Eligibility:~      Healthy, right-handed adults age 18-70 years old.~      Design:~      Participants will be screened with a physical exam and questions about their handedness.~     They may have a urine test.~      Participants will have 1 or 2 clinic visits. The first visit will last about 1.5 hours. The~     second will last about 3 hours.~      Participants will have structural magnetic resonance imaging (MRI). A strong magnetic field~     and radio waves take pictures of the brain. Participants will lie on a table that slides in~     and out of a metal cylinder.~      Participants may have transcranial magnetic stimulation. A wire coil is held on the scalp. A~     brief electrical current is passed through the coil and creates a magnetic pulse that~     stimulates the brain. Participants will wear a pair of glasses or a headband with small~     sensors so researchers can track head position.~      Participants will perform a simple index finger movement task.~      Participants may have surface electromyography from at least two hand muscles. Small metal~     disk or adhesive pad electrodes will be taped to the skin. Participants will be seated in a~     comfortable chair with their hands placed on a pillow.~      Participants may have an electroencephalography. A cap with small disc electrodes will be~     placed on the scalp.~   "
2976|NCT03018249|"~     This randomized phase II trial studies how well medroxyprogesterone acetate with or without~     entinostat before surgery works in treating patients with endometrioid endometrial cancer.~     Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally.~     Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Given medroxyprogesterone acetate with or without entinostat may work better in~     treating patients with endometrioid endometrial cancer.~   "
2977|NCT03018236|"~     This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use~     disorders. Alcohol users will be split in two groups, one will receive the active~     N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The~     effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress~     biomarkers will be evaluated.~   "
2978|NCT03018223|"~     The purpose of this study is to find out if a combination of drugs (these are called:~     cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better~     against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a~     related partially matched (haploidentical) donor. As part of the treatment for their blood~     cancer, participants need a hematopoietic cell transplantation (HCT) to improve their~     chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs~     is needed to prevent GVHD and facilitate acceptance of the graft.~   "
2979|NCT03018210|"~     The proposed study will be a multi-centre, prospective, observational cohort to determine if~     psychological well-being has an impact on the outcome of surgical repair for rotator cuff~     tears.~   "
2980|NCT03018197|"~     The purpose of this pilot study is to examine the use of a personal health record to improve~     medication adherence among patients with non-valvular atrial fibrillation taking dabigatran~     for primary prevention of embolic stroke.~   "
2981|NCT03018184|"~     Patients with inherited muscle diseases can have several problems in their muscles, which~     can be both structural and metabolic. All the different diseases can affect the~     contractility of the muscles. The aim of the study is to investigate the relation between~     muscle strength and contractile cross sectional area (CCSA) in the thigh and calf in~     patients affected by inherited muscle diseases.~   "
2982|NCT03018171|"~     Our study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in~     combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor~     performance and on maternal fetal well-being.~   "
2983|NCT03018158|"~     The objective of this study was to compare level of artifact while tongue at rest and in~     motion of dentulous subjects.~   "
2985|NCT03018132|"~     This study is designed to comprehensively investigate the anti-inflammatory role of vitamin~     D in reproductive aged women, and its association with preeclampsia and depression. Findings~     will have substantial impact providing new information implicated in the development of~     preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive~     fluid, and kidney stress) and postpartum depression (after birth).~      Additionally, the study is designed to understand how early mental health screening and~     evaluation can help pregnant women reduce their risk of developing postpartum depression.~     Testing the acceptability and effectiveness of this mental health screening, education and~     referral program at Cedars-Sinai Medical Center will provide valuable patient centered~     qualitative and quantitative data that can be used in future services planning.~      The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.~   "
2986|NCT03018119|"~     The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage~     consensus bundle to provide every United States birthing facility consistent, validated~     practice guidelines. To facilitate implementation of each element of this bundle at the~     participants large tertiary center, the investigators utilized the Delphi method to identify~     deficiencies, perceived barriers to implementation, and multidisciplinary consensus on~     changes with high feasibility and impact on patient care.~   "
2987|NCT03018106|"~     Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing~     postmenopausal female population, and the most common symptom is dyspareunia. Vaginal~     estrogen is the most common treatment for VVA, but it only marginally improves overall~     sexual function, and many women and clinicians avoid using it because of the risks of~     exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen~     receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and~     has shown improvements in sexual health that are superior to vaginal estrogen. 104 women~     will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of~     0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The~     improvements in sexual health and VVA symptom severity will be compared in each group. This~     study will help determine if ospemifene is a better treatment medication than conjugated~     estrogens.~   "
2988|NCT03018093|"~     The trial is a single arm, single-center, non-randomized phase I clinical trial which is~     designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with~     relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)~   "
2989|NCT03018080|"~     The primary objective of this study is to assess the safety and feasibility of the following~     two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by~     paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus~     pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4~     treatment-related adverse event rate for each cohort and compare them to relevant historical~     controls.~   "
2990|NCT03018067|"~     This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action,~     safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify~     are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675~     10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).~   "
2991|NCT03018054|"~     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the~     efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate~     active ulcerative colitis. Participants will be stratified by prior therapeutic treatment~     and Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams~     (mg), E6007 60 mg or placebo.~   "
2992|NCT03018041|"~     This is a long-term intervention study on the effects of marine n-3 PUFAs in renal~     transplantation. Our hypothesis is that patients treated with marine n-3 PUFA~     supplementation will have less decline in kidney transplant function compared to patients~     treated with placebo.~   "
2993|NCT03018028|"~     This trial is conducted in Asia. The aim of this trial is to investigate the dose-response~     relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide~     versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes~     mellitus~   "
2994|NCT03018015|"~     The present study will be conducted in order to assess bioequivalence of the Test product~     (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated~     tablet), an approved market product in the European Union. Testing for bioequivalence will~     be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted~     administration of ibuprofen.~      In addition to the conventional immediate release tablet used as Reference 1, a soft capsule~     formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example~     for a product with a very fast absorption rate.~      All 3 immediate release preparations contain 400 mg ibuprofen.~   "
2995|NCT03018002|"~     The purpose of this study is to evaluate the comparative effectiveness of a congregation,~     clinic and integrated case management-based intervention for sustainable testing and~     retention on linkage to care, engagement, retention and viral load suppression of women and~     children infected with HIV.~   "
2996|NCT03017989|"~     Endometriosis is a common disease for which the current gold standard for diagnosis is a~     diagnostic laparoscopy with histologic confirmation. However, during the diagnostic~     laparoscopy endometriotic lesions are hard to identify due to the many appearances of~     endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence~     imaging will provide real time image enhancement for the detection of endometriotic lesions~     by using the different vasculature in the endometriotic lesions. This hypothesis will be~     tested in a prospective study with 15 patients scheduled for an elective diagnostic~     laparoscopy for suspected endometriosis.~   "
2997|NCT03017976|"~     This study aims to assess the influence of exposure to swimming pool environment on~     respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool~     attendants.~   "
2998|NCT03017963|"~     The purpose of this trial is to evaluate the safety and maximum tolerable dose (MTD) of~     sodium thiosulfate in patients presenting with an acute coronary syndrome and treated with~     primary percutaneous coronary intervention (PPCI) via radial approach in adjunction to~     standard treatment.~   "
2999|NCT03017950|"~     The purpose of the study is examining and comparing the pharmacokinetic drug interaction and~     safety of both single administration and combination administration of CKD-330 and D086 to~     healthy male subjects~   "
3000|NCT03017937|"~     Clinical trials have suggested that this device is effective in mitigating changes in brain~     structure and function in athlete populations. The purpose of the current study is to~     measure the response of the jugular vein to various pressures applied by a generic~     compression device across various ages and gender. The relative jugular vein response will~     be measured using ultrasound.~   "
3001|NCT03017924|"~     The purpose of the study is to monitor changes in brain structure and function between the~     pre-training and post-training, in a population of tactical team members wearing the Device~     and compared to a similar population not wearing the device. Secondly, the purpose is to~     determine the protection of the device relative to amount and magnitude of sustained head~     impacts.~   "
3002|NCT03017911|"~     This is a prospective monocentric study of PICC Line complications use in 5 medical and one~     surgical units of Brest Medical University Hospital.~      To evaluate the incidence of the following complications: infections, thromboses, mechanical~     and hemorrhagic, at month 3 post-intervention.~      Also evaluating:~        -  the management of these PICC Line related complications,~        -  risk factors for such complications,~        -  and the mortality-related outcomes.~   "
3003|NCT03017898|"~     The purpose of this study is to determine whether treatment with laser coagulation is an~     effective and safe treatment option for patients with anal fistula~   "
3004|NCT03017885|"~     This active surveillance will include all NSCLC patients treated with nintedanib per the~     inclusion/exclusion criteria at approximately 20 selected centers until it is confirmed that~     100 patients treated with nintedanib are included and that baseline characteristics of 100~     additional patients (or as many patients as in the nintedanib group if <100) planned to be~     treated with single agent docetaxel are collected from the same centres during the same time~     frame, or until a maximum of two years, whichever occurs first~   "
3005|NCT03017872|"~     D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line~     antiretroviral therapy (ART). The study compares a novel regimen of second-line ART~     (dolutegravir and darunavir pharmaco-enhanced with ritonavir) with the WHO recommended~     regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 610 participants~     from 10 predominantly low-middle income countries will be followed for 96 weeks with the~     primary endpoint at week 48. The design is based on the hypothesis that the new regimen will~     be non-inferior to SOC in terms of virologic control while being easier to take,~     economically viable and affording simplification of treatment programs.~   "
3006|NCT03017859|"~     A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC)~     in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to~     continuous positive airway pressure (CPAP) treatment.~   "
3007|NCT03017846|"~     Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment~     option. Treatment is often available in private practice offices, where a prescribing~     physician may offer a non-FDA approved treatment on an individualized basis. The situation~     is different in many hospital and academic settings, such as our own for example, where the~     formulary is defined through a FDA-approved indication. The absence of an indication~     precludes its addition to many hospital formularies, thus limiting the options available to~     a prescribing physician and denying patient access to a treatment offered in the private~     practice setting. An indication and formulary status require controlled clinical trials on~     the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this~     commercially-viable cantharidin formulation has a comparable safety and efficacy profile as~     formulations previously studied under conditions which most closely match the what has been~     historically done in the clinic.~   "
3008|NCT03017833|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of TAK-228 and metformin that can be given to patients with advanced cancer. The~     safety of the drug combination will also be studied.~   "
3009|NCT03017820|"~     This phase I trial studies the best dose and side effects of recombinant vesicular~     stomatitis virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide~     symporter [NIS]) in treating patients with multiple myeloma, acute myeloid leukemia, or~     T-cell lymphoma that has come back or does not respond to treatment. A virus, called~     VSV-hIFNbeta-NIS, which has been changed in a certain way, may be able to kill cancer cells~     without damaging normal cells.~   "
3010|NCT03017807|"~     A single-central,open-label,safety,pharmacokinetics,phase I study. Biological:Recombinant~     Anti-EGFr Antibody Two dose levels: Low-dose level patients received initial dose 100 mg/m2~     and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable~     toxicity or death or withdraw informed consent.High-dose level patients received cetuximab~     initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance~     to the disease progression or unacceptable toxicity or death or withdraw informed consent.~   "
3011|NCT03017794|"~     This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A~     (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy~     (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA~     level is measured before the start of RT and/or the start of neoadjuvant ADT for patients~     undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined~     post-RT time points. The study will analyze the followings: 1. Change in CgA level at~     various pre-defined post-RT time points from the baseline, 2. Correlation between the extent~     of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the~     extent of post-therapy CgA change and treatment outcome.~   "
3012|NCT03017781|"~     The primary purpose of this study is to compare, over 24 months, the time spent with~     clinically significant mood symptoms (ie, mania, depression), as measured by the~     Longitudinal Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale~     (PSR), in offspring of bipolar parents with and without at least mild impairment in~     psychosocial functioning.~   "
3025|NCT03017612|"~     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near~     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and~     intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of~     a hydrogel material, implanted under a lasik flap. Subjects must require reading add from~     +1.50 D to +2.50 D. Subjects must have a preoperative manifest refraction spherical~     equivalent of -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop~     Near Vision Inlay will be implanted in the non-dominant eye.~   "
3013|NCT03017768|"~     Esophageal hypersensitivity is considered an important pathophysiological mechanism in~     patients suffering form non-erosive gastro-esophageal reflux disease. Serotonin (5-HT) is~     predominantly found in the central nervous system and in the gastro-intestinal (GI) tract.~     5-HT plays a major role in the regulation of GI secretion, motility and sensitivity, and has~     been associated with emotion regulation. Acute tryptophan depletion (ATD) temporarily~     reduces the availability of tryptophan (TRP), thereby decreasing central and peripheral 5-HT~     synthesis. From previous studies, ATD is known to affect GI physiology and enhance visceral~     pain perception in the colon. The aim of the study was to investigate the effect of ATD on~     esophageal sensitivity in healthy volunteers (HV).~      Esophageal multimodal sensitivity was assessed after intragastric infusion of an amino-acid~     mixture (AA-mix) containing 15 AAs with TRP (control condition) or without TRP (ATD~     condition). After an incubation period of 5 hours, a probe with a polyurethane bag was~     positioned in the distal esophagus. Thermal (recirculating a heated saline solution through~     the bag), mechanical (increasing bag volume), electrical (2 stimulation electrodes) and~     chemical sensitivity (modified Bernstein) were tested and at 3 time points blood samples~     were collected for biochemical analysis. General mood was assessed by the Positive and~     Negative Affect Schedule (PANAS) and the State-Trait Anxiety Inventory (STAI)~     questionnaires.~   "
3014|NCT03017755|"~     This is a survey to help understand the influences related to the decision for Adolescent~     Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then~     plans to create a decision aid to help families when making a decision about the treatment~     choice being presented to them.~   "
3015|NCT03017742|"~     The purpose of this study is to determine the clinical utility of triage screening for~     anemia and COP in the ED setting.This is a prospective, nonrandomized, multi-center study of~     the performance of simultaneous non-invasive testing for two common disorders (COP and~     anemia). We will determine the limits of agreement and performance characteristics of~     non-invasive SpCO and SpHb values compared to standard blood tests for measurement of COHb~     and hemoglobin, in the emergency department setting.~   "
3016|NCT03017729|"~     The purpose of this study is to assess the longitudinal attainment of subject centred and~     functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after~     abobotulinumtoxinA injection (including following repeated injection cycles where they~     occur) alongside spasticity management used in real life settings over a period of 18 months~     (and a maximum of six injection cycles).~   "
3017|NCT03017716|"~     Articular involvement is the most frequent extra-intestinal manifestation of inflammatory~     bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial~     involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing~     spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis,~     dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall~     pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset,~     improves after exercise but not with rest, and is associated with morning stiffness. Up to~     now, several criteria sets have been proposed to define IBP. Studies conducted in various~     populations have confirmed a high sensitivity and specificity for the Berlin criteria.~     Celiac disease (CD) is an autoimmune systemic disease having among its clinical~     manifestations frequent symptoms common to rheumatologic diseases. Recently, it has been~     reported that a consistent percentage of the general population consider themselves to be~     suffering from problems caused by wheat and/or gluten ingestion, even though they do not~     have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten~     Sensitivity' (NCGS) or Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is~     characterized by combined gastrointestinal and extra-intestinal or systemic manifestations.~     Many patients affected with CD and NCWS complain of IBP-like symptoms, which generally~     improve, together with the other clinical manifestations of the diseases, during a~     gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the~     effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or~     standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence~     of IBP in CD and in NCWS patients.~   "
3018|NCT03017703|"~     The importance of Aldosterone for endothelial function and Insulin resistance observed~     within patients with type 2 diabetes~   "
3019|NCT03017690|"~     An observational time and motion study in a clinical oncology setting is utilized in order~     to measure and compare product attributes and overall product efficiency between lanreotide~     and octreotide LAR.~   "
3020|NCT03017677|"~     In this study the investigators is aimed to establish the MPS screening algorithm for high~     risk patients who had medical history of previous surgical repair or presence of inguinal~     and/or umbilical hernia with combination of any ENT related surgery or examination in~     Taiwan.~   "
3021|NCT03017664|"~     This quality improvement project will include a practice change based on national guidelines~     for the nutritional management of PICU patients.~   "
3022|NCT03017651|"~     This protocol will determine the pK profile of two different omega-3 fatty acid supplements~     on plasma EPA and DHA levels.~   "
3023|NCT03017638|"~     Pain after abdominal surgery can be extensive. Pain control is an important component of~     patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown~     to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced~     Recovery after Surgery (ERAS) protocols.~      Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy~     has been shown for abdominal surgeries, and also for different laparoscopic procedures, such~     as ovarian surgery.~      The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy~     surgeries, using serial pain score assessments and overall opioid consumption; its effect on~     patient satisfaction; and its effect on the development of postoperative respiratory~     complications. This study is a prospective clinical trial assessing the effect of~     application of QLB as a regional analgesic technique for primary laparoscopic colectomy, in~     comparison to a historical retrospective cohort.~   "
3024|NCT03017625|"~     Chronic obstructive pulmonary disease (COPD) is known for development of severe~     cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD~     (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets~     contribute to acute cardiovascular events and atherosclerosis. When platelets are activated,~     they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early~     process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD~     is scarcely studied. This study aims to address this gap by investigating platelet function~     and coagulation in patients with AE-COPD and after convalescence.~   "
3026|NCT03017599|"~     To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle~     for EUS-guided fine needle biopsy in pancreatic solid lesions.~   "
3028|NCT03017573|"~     SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at~     different time points in ovarian, triple negative breast and head and neck cancer patients.~     This study will allowed to identify new molecular and/or immunological biomarkers associated~     with clinical and biological features of the tumors. All patients will receive standard~     treatment according to the stage of the diseases and usual procédures.~   "
3029|NCT03017560|"~     The primary purpose of this study is to test the effects of a targeted, computerized~     cognitive training program on verbal memory in older women who have undergone chemotherapy~     treatment for early-stage breast cancer. As measured by neuropsychological assessment, this~     treatment will result in improved verbal memory. Secondarily, processing speed and naming~     abilities are expected to improve. Enhanced self-perception of cognitive ability is also~     expected.~   "
3030|NCT03017547|"~     Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either~     IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study~     participation will be for a total of 28 days.~   "
3031|NCT03017534|"~     The mechanism responsible for improvement following manual physical therapy techniques is~     unknown. Previous studies have indicated both biomechanical and neurophysiologic effects~     which may be responsible for clinical changes observed. Yet, other studies report clinical~     changes following sham interventions. Through a mixed-methods design, this study aims to~     gain more understanding of the social and contextual factors that may be related to the~     improvement often observed following manual therapy techniques.~   "
3032|NCT03017521|"~     The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog~     (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently~     aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral~     allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent~     anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose~     to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with~     advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of~     K-BASKET trial.~   "
3033|NCT03017508|"~     The goal of the current proposal is to examine if sublingual riluzole can reduce anxiety in~     people with social anxiety disorder during a public speaking task.~   "
3034|NCT03017495|"~     The main objectives of this phase 1 trial are to evaluate the effect of food on the~     pharmacokinetics (i.e. how long and how much a compound is present in the blood) of~     ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam,~     a CYP3A4 substrate.~   "
3035|NCT03017482|"~     The purpose of this project is to track initiation and the first year of clinical use of the~     newly FDA approved 670G closed loop insulin delivery system by patients who have requested~     this system. Our goal is to evaluate our clinical approach to starting this newly approved~     system. Since the investigators are only following patients who have already decided to~     start the 670G, the investigator does not assign specific interventions to the subjects of~     the study; thus this is a Observational study.~   "
3036|NCT03017469|"~     Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives,~     which can lead to adverse personal and professional outcomes. While workplace stress cannot~     be eliminated, nurses can learn techniques to build resilience, mitigate stress, and~     decrease fatigue. Organizational employee health, wellness, and assistance programs are all~     intentioned to provide this type of support; however, nurses often lack awareness of options~     and opportunities, and access can be a challenge. The purpose of the proposed study is to~     assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance~     resilience and promote awareness of organizational resources for health, wellness, and~     employee assistance. We will evaluate the impact of participation in ARISE on resilience and~     other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight~     Organization designated by the Registered Nurses Association of Ontario (RNAO), this project~     will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to~     Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse~     Fatigue in Health Care.~   "
3037|NCT03017456|"~     Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate~     cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers~     with the goal of identifying and tracking unmet supportive care needs of patients with~     localized PC and responding to these needs through survivorship care. The current randomized~     control trail (RCT) will focus on the development and evaluation of a facilitated electronic~     Prostate Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop~     an appropriate and tailored SCP and transition care delivery process; and 2) to conduct an~     RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care~     (UC) on patient activation (primary outcome) and access to services, self-Management~     support, satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data~     from a multi-site prospective database- Prostate Cancer Survivorship Information System~     (PC360-IS) will be used to electronically populate the survivorship care plans. Overall,~     this proposal represents initial steps in uniting the country in sharing programmatic~     resources, data, expertise, and enthusiasm to transform survivorship care for men with PC~     and their families.~   "
3038|NCT03017443|"~     The objective of this study was to determine changes in body weight and related outcomes~     achievable over a 16-week period in response to three different commercially available~     weight loss programs (Nutrisystem) providing pre-packed, portion controlled foods and~     beverages, each compared to a self-directed diet, in apparently healthy overweight and obese~     men and women.~   "
3039|NCT03017430|"~     It is a single blind randomized symptom triggered study to assess efficacy and safety of~     pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.~     clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.~   "
3040|NCT03017417|"~     The proposed study will assess the feasibility of an exercise and dietary intervention in~     men with castrate resistant prostate cancer with secondary outcomes assessing improvements~     in physical functioning, fatigue, quality of life, and body composition.The study will have~     2 arms, with one set of participants randomized to resistance exercise training intervention~     plus dietary advice and the other arm will be standard of care plus exercise advice.~   "
3042|NCT03017391|"~     Nausea and vomiting are frequently occurring problems in the palliative phase of patients~     with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting.~     Often the cause of nausea and vomiting is multifactorial and symptomatic treatment is~     necessary.~      Potential drugs for symptomatic anti-nausea therapy are metoclopramide, serotonin~     antagonists, the combination of both and dexamethasone as rescue medication in case of~     failure. There is no data that depicts which strategy is the best. This study will be~     conducted to unravel which treatment algorithm is most successful.~   "
3043|NCT03017378|"~     The study is a single centre, phase I, open, randomized, by intranasal and sublingual~     application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21)~     TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.~   "
3044|NCT03017365|"~     It is well documented that both balance and resistance training have the potential to~     mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a~     simultaneously executed balance and resistance training, namely resistance training on~     uneven surfaces is an eligible, effective and safe alternative training program to mitigate~     intrinsic fall risk factors in older adults. However, knowledge about the effects of~     specific adductor and abductor training has advantages over traditional resistance training~     and resistance training on unstable surfaces regarding forward propulsion. Further, the~     effects of different kinds of resistance training on cognition, especially embodiment is~     investigated.~   "
3045|NCT03017352|"~     Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack~     of endocrine insulin production due to an autoimmune destruction of beta-cells in the~     pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling~     fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma~     glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c~     (HbA1c) of <7.0% as the treatment goal.~      Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight~     gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment~     compliance.~      The abovementioned problems associated with insulin treatment in T1D can also be seen in~     insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of~     insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in~     reducing the weight gain and insulin dose in insulin-treated patients with T2D without~     exacerbating the risk of hypoglycaemia.~      Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators~     intend to evaluate it in a randomized, controlled trial as add-on therapy to standard~     insulin therapy for patients with T1D.~      The investigators hypothesise that the add-on of exenatide to insulin therapy in patients~     with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve~     glycaemic control without increasing the risk of hypoglycaemia.~   "
3046|NCT03017339|"~     The purpose of this study is to investigate the effects of a functional exercise program~     associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of~     life of individuals with fibromyalgia. Half of participants will receive functional exercise~     and LLLT, while the other half will receive functional exercise and placebo LLLT.~   "
3047|NCT03017326|"~     The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and~     Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment~     of children diagnosed with HB.~      Children with HCC will be included as a separate cohort.~   "
3048|NCT03017313|"~     The purpose of the protocol, is to determine the percentage of patients for whom the initial~     LHRH prescription has been renewed~   "
3049|NCT03017300|"~     Inspiratory muscle training（IMT）was an rehabilitation therapy for stable patients with~     chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains~     undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic~     mobilization represented by transdiaphragmatic pressure（Pdi）and neural respiratory drive~     expressed as corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide~     vital information to select the proper IMT device and loads in COPD, therefore make curative~     effect of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively~     measured and compared during inspiratory resistive training and threshold load training in~     stable patients of COPD.~   "
3050|NCT03017287|"~     The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with~     uncontrolled diabetes treated with MDI.~   "
3051|NCT03017274|"~     Recently it has been reported that a consistent percentage of the general population~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have CD or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the~     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat~     causes the symptoms in NCGS patients, and the investigators also showed that these patients~     had a high frequency of coexistent multiple food hypersensitivity. The clinical picture of~     NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea~     and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis)~     and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy~     mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm~     numbness, and anemia). Nowadays no data are available on the abdominal ultrasonographic~     features of NCWS patients. Therefore, the aim of the present study is to evaluate the~     abdominal ultrasonographic features of NCWS patients in comparison with patients affected~     with celiac disease.~   "
3052|NCT03017261|"~     The goal of this prospective, non‐randomized, multicenter clinical trial is to determine~     whether robotic‐assisted total knee arthroplasty performed with TSolution One® System is~     safe and effective for use as an alternative to the conventional manual techniques. Clinical~     and radiographic outcomes for robotic‐assisted total knee arthroplasty performed with the~     TSolution One® System will be collected preoperatively, intraoperatively, and~     postoperatively up to a follow‐up period of 3 months. These outcomes will be compared to the~     ones reported in the literature for conventional manual techniques.~   "
3783|NCT03007706|"~     This study aims to determine the effectiveness of skin cleansing and prophylactic~     antibiotics given to women undergoing a cesarean section for reducing the incidence of~     postpartum infectious morbidity and to assess potential maternal adverse effects and any~     impact on the infant.~   "
3053|NCT03017248|"~     This study aims to determine the efficacy and safety of low dose ketamine in association~     with IV morphine in the management of acute moderate to severe pain in emergency department.~      The investigators hypothesize that low dose ketamine will result in more effective pain~     control than morphine alone and will not be associated with an increase in adverse events.~   "
3054|NCT03017235|"~     The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and~     Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects~     undergoing colonoscopy.~   "
3055|NCT03017222|"~     Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and~     underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.~     Patients who developed PONV within the first 2 hours after anesthesia received~     intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg.~     Patients were then observed for 24 hours after drug administration. The incidence of nausea~     and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at~     0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the~     rate of patients exhibiting complete response, defined as no emesis and no further rescue~     antiemetic medication for 24 hours after drug administration.~   "
3056|NCT03017209|"~     This study is a randomized controlled trial with a main goal to assess the effects of a~     locally-prepared food for prevention of malnutrition and stunting, in comparison with~     standard village practices and also a widely available aid food supplement in 8-12 villages~     in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome~     will be cognitive tests of executive function. Secondary outcomes will be changes in~     standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young~     children living in villages in rural Guinea-Bissau. This is a within-village randomization~     at the level of the family, and all children will receive a dietary intervention.~   "
3057|NCT03017196|"~     This study is designed to answer the following questions: Is the My Life, My Healthcare~     Discussion Aid feasible for use in primary care? Does it positively impact patient and~     healthcare teams' care experience and communication, while reducing patient treatment~     burden?~      Through implementation of the My Life, My Healthcare Discussion Aid for patients with~     chronic conditions, the study team hypothesizes that it will be feasible to implement in~     routine primary care practice and positively impact patient and healthcare teams experience~     of chronic care, while reducing patient treatment burden.~   "
3058|NCT03017183|"~     Study participants will be selected from clinical routine patients with endobronchial~     infiltration of a central lung cancer and indication for bronchoscopic sampling.~      Consented patients will undergo bronchoscopy for tumor sampling applying two routine~     sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling).~     The sequence of both sampling methods will be randomized in advance.~      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.~     The corresponding analysis results will be compared between sampling methods.~      Assignment of a subject to a particular therapeutic strategy is not influenced by this~     protocol. Medicinal products will be used according to current practice and marketing~     authorisation.~   "
3059|NCT03017170|"~     A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried~     cranberry at 500 mg daily in women with overactive bladder for 6-months.~   "
3060|NCT03017157|"~     The study plans to investigate whether recovery of the heart function after acute anterior~     myocardial infarction is dependent upon improvement in thyroid gland functioning.~   "
3061|NCT03017144|"~     Cardiac arrest is handled by cardiopulmonary resuscitation which is a time critical~     emergency situation. The actions during resuscitation are lead by international guidelines.~     Traditionally, the main focus of the training has been on medical knowledge and technical~     skills (TS). Nowadays non-technical skills (NTS), such as communication, teamwork behaviour,~     and leadership, are considered at least equally important.~      The aim of this study is to evaluate both TS and NTS of the resuscitation team during~     real-life resuscitation situations using a validated assessment tool. The correlation of TS~     and NTS will be analyzed. Findings from this study may help to recognize the possible~     weaknesses and issues which could be improved by training. Hypothesis is that that TS are~     probably in a high level, but some improvement points of NTS are ought to be known better.~     Investigators also hypothesis that the good NTS performance in resuscitation is accompanied~     by good TS performance.~   "
3062|NCT03017131|"~     This phase I trial studies the side effects of genetically modified T cells and decitabine~     in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has~     come back or has not responded to previous treatments. White blood cells called T cells are~     collected via a process called leukapheresis, genetically modified to recognize and attack~     tumor cells, then given back to the patient. Decitabine may induce and increase the amount~     of the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically~     modified T cells and decitabine may kill more tumor cells.~   "
3063|NCT03017118|"~     The aim of this study is to assess whether the use of a commercially available~     nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients~     with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the~     impact of turmeric on basal joint arthritis.~   "
3064|NCT03017105|"~     Proximal humerus fractures (break of the top part of the upper arm bone) are common in older~     people with poorer bone quality. Often patients do not undergo surgery for these fractures:~     the bone fragments may be in an acceptable enough position to be able to heal naturally, or~     the patient may not be well enough medically to undergo an operation. These patients need to~     wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly~     when they are unable to be used. This research project will look at whether~     strength-training the opposite/uninjured limb, known as cross education, has any effect on~     preserving the function of the injured/fractured limb. Participants will be randomised into~     two groups using minimisation, that is to say the groups will have balanced numbers in terms~     of exact pattern of fracture and gender. One group will receive traditional rehabilitation~     exercises and treatment by the physiotherapist for their injured limb; the other group will~     receive the same but in addition will also undergo a strength-training exercise programme~     for their uninjured limb. Only qualified physiotherapists with experience of treating this~     patient cohort will be involved. Sessions in the physiotherapy department will last up to 30~     minutes each and will comprise of: patient review, exercise progression, and advice~     giving/question answering; home exercise programmes will be expected to be completed 2-3~     times daily and last up to 30 minutes each; number of sessions will be agreed between the~     participant and treating physiotherapist with treating ending once an agreed, acceptable~     level of function has been achieved. The Oxford Shoulder Score patient-reported outcome~     measure will be completed by the participant at 6 and 12 weeks and the European Quality of~     Life (EuroQoL)-5D-5L at 12 weeks after commencement of treatment.~   "
3066|NCT03017079|"~     Malnutrition and underfeeding are major challenges in caring for critically ill patients.~     Continuous feeding were thought to be better tolerated by patients with the limited~     absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube~     clogging and required the patient to be attached to an infusion pump for significant periods~     of time. Intermittent infusion resembled more physiological feeding process, which allowed~     greater patient mobility and might reach goal enteral calories earlier, and the latter were~     considered to effectively decrease the length of stay (LOS)-in-hospital and mortality.~     However, it also had some previous study found that intermittent infusion had more~     complications, such as diarrhea, regurgitation than continuous. Some study found that it was~     an efficient way to prevent aspiration and reflux by increasing the enteral nutrient~     solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of~     this was to study whether receiving semi-solidification of nutrients could increase the~     percent prescribed calories received by improving the feeding intolerance, and secondary~     goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital,~     lung infection, 30-days mortality and the glycemic variability (GV).~   "
3067|NCT03017066|"~     The purpose of this study is to compare the gastric volume in pediatric patients who~     followed preoperative fasting guideline using ultrasound.~   "
3068|NCT03017053|"~     Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate~     management of the neck is therefore of paramount importance in the treatment of oral cancer.~     However, there is still some controversy on the treatment of early maxillofacial~     malignancies. Currently, investigators have no accurate uniform treatment standards,~     including the National Comprehensive Cancer Network (NCCN) recommended between surgery and~     radiotherapy options. Clinical evaluation indicated that lymph node-negative patients~     eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients~     with true node-negative, preventive cervical lymph node dissection is obviously~     over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.~   "
3069|NCT03017040|"~     The investigators hypothesize that there is no relationship between in vivo kinematic~     abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries~     (SLIL)~      The secondary null hypotheses are that: There are no kinematic differences between subjects~     with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to~     the contralateral wrist without scapholunate ligament injury.~      The investigators aim to answer to the below questions:~        -  What are baseline validated outcomes for subjects with SLIL injury?~        -  What are baseline physical measures (range of motion, Jamar Dynamometry)?~   "
3070|NCT03017027|"~     The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation~     (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by~     comparing responses between TDV and non-TDV control groups.~   "
3071|NCT03017014|"~     The primary objective of this study is to evaluate long-term effectiveness of adalimumab in~     pediatric participants starting a treatment for Crohn's disease in real life conditions,~     namely to describe the time to loss of clinical benefit in a time to event approach. Main~     secondary objectives are to describe growth and pubertal development and to describe~     long-term safety. The participants will be followed-up up to 10 years.~   "
3072|NCT03017001|"~     Omega-3 polyunsaturated fatty acids (w-3-PUFA) may have a potential role in enhance the~     postoperative balance of host immunity and reduce the incidence of postoperative atrial~     fibrillation (POAF). CHO drinks 2h before the induction of the anesthesia may reduce the~     necessity of vasoactive drugs preoperatively. the aim of this study was to investigate the~     effect of these two nutrients in patients undergoing CABG with cardiopulmonary bypass (CPB)~     on morbidity at ICU, mainly POFA. This is a double-blind controlled randomized trial.~   "
3073|NCT03016988|"~     Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor~     survival. This study to evaluate the efficacy and safety of Bortezomib combined with~     Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for~     high dose therapy and transplantation.~   "
3074|NCT03016962|"~     The potential benefit of using the cap is that it helps in luminal orientation at bends by~     keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in~     patients with a history of abdominal surgery is considered to be difficult due to~     adhesion-related bowel angulations. There were few study evaluating usefulness of~     cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators~     designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy~     in patients with prior abdominal surgery.~   "
3075|NCT03016949|"~     The study will evaluate the humoral immunogenicity in various schedule combinations of full~     dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the~     fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).~   "
3076|NCT03016936|"~     Multicentre international prospective cohort study designed to answer the question: In~     patients undergoing elevated risk noncardiac surgery, are METs estimated by questionnaire~     associated with perioperative major adverse cardiovascular events or cardiovascular~     mortality? If so:~        1. What is the optimal cut-off for METs estimated by questionnaire to predict~          perioperative major adverse cardiovascular events or cardiovascular mortality?~        2. How does the optimal cut-off compare with the currently guideline-endorsed 4-MET~          cut-off?~   "
3077|NCT03016923|"~     The proposed pilot study seeks to explore the effectiveness of Functional Electrical~     Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years)~     with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary~     outcome measures obtained pre- and post-intervention in a case series study design.~   "
3078|NCT03016910|"~     Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a~     morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign~     (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the~     influence of microvascular dysfunction and additional risk factors on plaque morphology and~     plaque burden in patients with diabetes mellitus.~   "
3079|NCT03016897|"~     ALS AT HOME is a single-center study of up to 250 participants being done to determine the~     extent to which frequent sampling can improve the qualities of outcome measures collected at~     home by study participants.~   "
3080|NCT03016884|"~     The reactivation of varicella zoster virus (VZV) (herpes zoster (HZ)) is of substantial~     public health concern. Updated ACR recommendations for RA treatment suggest that RA patients~     aged ≥ 50 years should be vaccinated before receiving biologic or tofacitinib therapy. The~     Investigators therefore propose a prospective study to evaluate the safety, tolerability,~     and immunogenicity of a zoster vaccine (Zostavax) in patients with RA, administered at least~     2 weeks prior to initiation of anti-TNF biologic and tofacitinib therapy for RA.~      This is a 6-week open-label prospective multi-center study evaluating the safety,~     tolerability, and immunogenicity of Zostavax vaccine in the RA population prior to~     initiation of biologic/tofacitinib therapy for RA. VZV-specific immune response to vaccine~     in RA patients will be compared to healthy control subjects ≥ 50 years immunized with~     Zostavax.~   "
3081|NCT03016871|"~     This phase II trial studies the side effects of nivolumab and to see how well it works when~     given together with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin~     lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such~     as nivolumab, may interfere with the ability of cancer cells to grow and spread. Drugs used~     in chemotherapy, such as ifosfamide, carboplatin and etoposide, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving nivolumab, ifosfamide, carboplatin and~     etoposide may work better in treating patients with Hodgkin lymphoma.~   "
3082|NCT03016858|"~     With the development of video-assisted thoracoscopic surgery (VATS) techniques and~     technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has~     been widely applied in VATS. A multicenter randomized parallel controlled study was applied~     in this study to assess the feasibility and safety of thoracoscopic bullectomy surgery under~     intravenous anesthesia with spontaneous ventilation versus tracheal intubation general~     anesthesia.~   "
3083|NCT03016845|"~     Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is~     lacking resulting in large variation of achieved exposure and possible inadequate therapy.~     The investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful~     method to individualize and optimize therapy for ciprofloxacin and eventually improve~     outcome.~      In a multi-centre, observational, open-label study the investigators aim to define : the~     model for estimation of renal function that most accurately predicts ciprofloxacin clearance~     in critically ill patients.~   "
3084|NCT03016832|"~     1. Name of Investigational Products Huangkui capsule.~        2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical~          Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)~        3. Trial Objectives Primary objective: To evaluate Huangkui capsule efficacy for treatment~          of type II diabetes proteinuria.~           Secondary objective: To evaluate the efficacy of Huangkui capsule on increasing eGFR,~          improve micro-inflammatory state, and improving Traditional Chinese medicine clinical~          efficacy.~        4. Trial Design Designed as a block randomized, double-blinded, parallel controlled,~          multi-center clinical trial.~   "
3085|NCT03016819|"~     This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the~     treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS),~     and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In~     participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the~     participants will receive AL3818, one-third of the participants will receive IV dacarbazine.~   "
3086|NCT03016806|"~     This study is a single-center, treatment protocol with 4 possible preparative regimens,~     designed to validate the process of umbilical cord blood stem cell transplantation at our~     institution.~   "
3087|NCT03016793|"~     P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft~     C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device~     Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number~     0—10~      Radiographic outcome:~      Outcome name Measurment Device Measurment unite Bone volume~      (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density~      (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would~     purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying~     than tricalcium phosphate alone in alveolar cleft grafting?~   "
3088|NCT03016780|"~     Ulcerative colitis is a common digestive system disease, the incidence is increasing in~     recent years.It is reported that the occurrence and development of ulcerative colitis is~     closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may~     be related to intestinal flora. Fecal microbiota transplantation as a new technology to~     rebuild intestinal flora has been used for several disease，but the efficacy of ulcerative~     colitis by fecal microbiota transplantation needs to be further explored.~   "
3089|NCT03016767|"~     Oral feeding in the neonatal period requires an accurate coordination between suction,~     swallowing and breathing. In premature new-borns and, depending on their gestational age,~     the coordinated work of those processes becomes jeopardised, being necessary to begin with~     an artificial enteral feeding. This situation results in lengthen their stay at the hospital~     until they are able to respond in a reliable way to their nutritional requirements orally,~     maintaining an adequate daily weight gain and without endangering their cardiorespiratory~     system.~      This project is an experimental, prospective, blinded, randomized study, aimed to determine~     whether the application of a manual oral stimulation protocol in premature infants,~     hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral~     full feeding, while improves quality of feeding and shortens hospitalization time.~   "
3090|NCT03016754|"~     This study is designed as a multi-center prospective observational study of newly diagnosed~     Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)~     recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is~     achieved. Although the study doesn't start until day 90, all eligible, consenting patients~     will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)~     use. The pre-study registry will allow us to collect early (90 day) outcomes and data in~     those patients who are likely to be eligible for the study at day 90, or are eligible, but~     refuse the study at day 90.~   "
5509|NCT02985060|"~     To study safety and feasibility of mild therapeutic hypothermia after successful~     recanalization by mechanical endovascular treatment in patients with acute ischemic stroke~     and proximal arterial occlusion.~   "
3091|NCT03016741|"~     This clinical trial studies cognitive function in men with prostate cancer treated with~     androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The~     investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes~     in brain structure or activity related to treatment that may be related to changes in~     cognitive function. The investigators are also looking for genetic variations that might~     make patients more or less sensitive to cognitive changes during treatment for prostate~     cancer.~   "
3092|NCT03016728|"~     More adolescents and young adults are surviving cancer than ever before. Many endure~     negative effects related to their cancer and its treatment, which reduces their quality of~     life and functioning. Physical activity is one strategy that has been shown to promote~     quality of life amongst cancer survivors. However, very little research has focused on~     adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized~     controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week~     home-based physical activity intervention in adolescent and young adult cancer survivors.~   "
3093|NCT03016715|"~     : Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA~     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong~     painful thick soles on their feet, and current standard of care is supportive. This pilot~     study will target the dominant mutant keratin proteins in the skin to ameliorate the~     severity of EB simplex. The purpose is to improve the function of EB simplex feet with an~     application of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway~     to down regulate the translation of defective keratin proteins and work through anti~     proliferative pathways.~   "
3094|NCT03016702|"~     The purpose of this study is to test whether two new cognitive stress tests may help~     distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The~     investigators are trying to understand how these cognitive stress tests work in people who~     have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of~     Alzheimer's Disease. Study subjects will undergo testing of memory and executive function~     during functional magnetic resonance image (fMRI) of the brain and also during a walking~     test.~   "
3095|NCT03016689|"~     While the maternal-newborn exchange of airway microbiota is well-documented, no studies have~     examined within-subject relationships among the mouth, sinuses, nasopharynx and lungs and~     the relative abundance of bacterial taxa at those sites. Recent evidence suggests the oral~     cavity may serve as a reservoir for pathogens that translocate to non-oral locations;~     oral-associated microbes infect most other body sites as evidence by 16S sequencing.~      By using a combination of oral and throat swabs, together with nasal suction of mucus~     samples, the investigators will use metagenomic sequencing to characterize the composition~     of bacterial communities at each anatomical site. Beginning at birth, a time-series of swabs~     will be collected from each subject, and monitor changes in the development of microbiota~     over time. By doing so, our studies will illuminate airway trafficking of both beneficial~     and pathogenic microbes and may represent an essential pathophysiological step towards~     shifting the balance between airway health and disease.~   "
3096|NCT03016676|"~     This study will give a new insight to the physiotherapy fraternity in the effects of spinal~     manipulation in as clinical practice, as well as the patient's community in quick~     re-establishment of functional ability, pain decrease, and improvement of quality of life~     for economic reasons. In this high opinion, application of short-term intensive spinal~     manipulation for non specific chronic low back pain treatment is desirable.~   "
3097|NCT03016663|"~     Prospective observational study to evaluate effects on washing to improve viability of fat~     grafts in breast lipofilling.~   "
3098|NCT03016650|"~     The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in~     patients undergoing percutaneous nephrolithotomy (PCNL).~   "
3099|NCT03016637|"~     This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may~     improve the diagnostic yield during biopsies of pancreatic lesions~   "
3100|NCT03016624|"~     To compare coronary healing after optical coherence tomography guided versus conventionally~     angiography guided percutaneous coronary intervention with the Magmaris bioresorbable~     scaffold.~   "
3101|NCT03016611|"~     To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial~     Infarction (STEMI) patients on platelet reactivity.~   "
3102|NCT03016598|"~     This study will investigate the effects of intranasal administration of oxytocin, a social~     neuropeptide, on reduction in stimulant use, enhancing group cohesion and therapeutic~     engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use~     disorder.~   "
3103|NCT03016585|"~     Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world~     population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by~     chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms~     associated with the presentation of the disorder. Interestingly, the etiology and underlying~     mechanism of FM are not completely understood, but previous findings suggest that autonomic~     dysfunction may explain some of the FM symptoms.~      Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic~     function which is associated with a reduction in vagal tone and increase in sympathetic~     activity. Therefore, autonomic function is a worthwhile target intervention in individuals~     with FM. Although traditional exercise ( both aerobic and resistance) has been shown to~     effectively improve HRV parameters and FM symptoms, most FM patients display a decline in~     adherence to traditional exercise and continue to experience considerable pain and fatigue~     years after the original diagnosis ultimately requiring medication to control their~     symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms~     in patients with FM, which will ultimately improve their physical and emotional functioning~     leading to a better quality of life.~      Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements,~     controlled breathing and mental concentration. TC training is safe for special populations~     and has previously shown to decrease pain, fatigue as well as other FM related~     symptoms.However, the potential role of TC training on autonomic function is largely~     unexplored.~      The investigators hypothesis is that 12 weeks of TC training would improve our primary~     outcome of autonomic function through improvements in sympathovagal balance, and the~     secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and~     flexibility.~   "
3104|NCT03016572|"~     This research study is designed to answer specific questions about new ways to provide~     services for youth at-risk of suicide.~   "
3105|NCT03016559|"~     The purpose of this study are to compare angles of hip joint between before and after~     releasing quadratus lumborum muscle.~   "
3784|NCT03007693|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215~     after multiple consecutive dose administrations and to characterize the pharmacokinetics~     (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.~   "
3106|NCT03016546|"~     Depression is a common perinatal complication that can have a profound, adverse effect on~     maternal and child health outcomes. The proposed study will directly address this important,~     but understudied area by evaluating the feasibility and preliminary effect of an innovative,~     integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for~     maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided~     by a model drawn from self-regulation and bioecological systems theory. Proactive counseling~     personalized to the patient and socio-cultural context is delivered by trained clinic~     personnel (e.g., counselors) to build problem solving and coping skills and linkages to~     mental health, HIV treatment and ancillary services. The theory-guided intervention approach~     has been found effective in improving the health behavior and outcomes (e.g., virologic) of~     vulnerable, marginalized HIV+ women and men in rural and urban settings in the US~     (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that~     it is well suited for the target population, its usefulness in addressing significant gaps~     in care among perinatal women.~      l women with co-morbid conditions in a different socio-cultural, limited resource setting~     has not been studied.~   "
3107|NCT03016533|"~     Dolutegravir (DTG) is a potent inhibitor of the human immunodeficiency virus type 1 (HIV-1)~     integrase that has been developed for the treatment of HIV. This is a phase 3b (PH3b),~     non-randomized, open-label, multi-center, treatment rollover study. The primary objective of~     this pediatric interventional study is to provide continued access to DTG for eligible~     participants who previously participated in the international maternal pediatric adolescent~     acquired immunodeficiency syndrome [AIDS] clinical trials (IMPAACT) P1093 study (parent~     study) and who cannot locally access DTG in the public sector. The P1093 study was designed~     to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of DTG in~     HIV-1 experienced adolescents and children as well as treatment-naive infants and toddlers.~     Participants who have no evidence of virological failure (VF) and who have tolerated DTG in~     the parent study without any significant toxicity leading to the permanent discontinuation~     of this drug and withdrawal from the parent study will be considered for this open-label~     continued access study. Participants will be receiving their age/weight appropriate dose of~     DTG as defined in the parent study. The objective of this study will be supported through~     evaluation of serious adverse events. The duration of participant accrual into the study~     will extend until DTG receives local (by country) regulatory approval . Therefore,~     participants enrolled into this study will be those who will benefit from treatment and will~     continue to receive DTG until local (by country) regulatory approval and commercial or other~     availability occurs from another source (e.g. government programs, aid programs, assistance~     programs, etc.). Participants will be enrolled after all screening procedures have been~     completed. In most cases, the Screening visit will overlap with the participant's~     penultimate visit on the parent study (at Week 180 of P1093). Participants who meet all~     entry criteria may enroll and will be seen in the clinic every 12 weeks for a safety~     evaluation and to receive DTG. It is estimated that no more than 120 participants will be~     enrolled in this study.~   "
3108|NCT03016520|"~     The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164~     in healthy male volunteers.~   "
3109|NCT03016507|"~     The objective of this study is to evaluate the IOP variation before and 30 days after~     performing phacoemulsification through pneumatic tonometry, in addition to evaluating the~     factors possibly related to this variation.~   "
3110|NCT03016494|"~     The purpose of this study is to compare the safety and pharmacokinetics between~     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects~   "
3111|NCT03016481|"~     This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes~     Research Institute (PCORI) and will test an adapted priority-based patient navigation versus~     care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or~     referred from, University of Rochester Medical Center providers. The goal is to improve~     patient safety, depression, and health function over the course of 12 months. In the~     Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested~     in our first UR PCORI grant, in addition to meeting with a social worker, patients will work~     with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed~     over the course of the next 6 months to navigate services and overcome barriers. In~     addition, patients will receive referrals to other professionals based on their~     prioritization and meet with the CHW at the time and place of their choice. Patients in the~     Care as Usual- Social Worker (CAU-SW) arm, will do intake with a social worker, who follows~     hospital procedures for intake and referrals, does a needs assessment, and offers safety~     planning in referral.~   "
3112|NCT03016468|"~     This is a multicenter, single-arm trial to evaluate the safety of the transition from~     Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary~     Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10~     clinical trial centers. The treatment phase of the study will last approximately 16 weeks.~   "
3113|NCT03016455|"~     This study aims to better characterise B cell phenotype and functional abnormalities in~     kidney transplant patients producing donor specific antibody (DSA) and in those with chronic~     antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The~     functional analysis will help to better understand B cell-dependant mechanisms implied in T~     cell proliferation and better target future treatments.~   "
3114|NCT03016442|"~     Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the~     induction of labor~   "
3115|NCT03016429|"~     This protocol outlines a prospective study evaluating safety and clinical outcomes of~     magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable~     electrical devices (CIEDs) including pacemakers (PMs) and implantable~     cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base~     regarding this common clinical scenario. Specifically, the investigators aim to address~     whether results of MRI in PM/ICD patients affect physician decision making related to~     clinical management strategy and planning treatment interventions. Further, this study will~     evaluate whether the results of MRI in these patients affects patient outcomes related to~     survival and adverse events during or after MRI scanning.~   "
3126|NCT03016286|"~     Hypotheses of this study are~        1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body~          vibration (WBV)~        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this~          study is to test these hypotheses.~      Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied~     at 35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20~     minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling~     of the right ankle, and during WBV respectively.~   "
3127|NCT03016273|"~     Cesarean section is a surgical procedure used to deliver one or more babies. cesarean~     section is usually performed when vaginal delivery will put the mother or child's health or~     life at risk. In recent years, the number of cesarean section has risen worldwide.~   "
3116|NCT03016416|"~     Autonomic dysfunction is a common complication of stroke that may lead to poor~     rehabilitation outcomes and to increase in mortality. The severity of the autonomic~     dysfunction can be measured in many ways, but the most common way is assessment of the~     sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that~     the plasticity of the brain can influence the autonomic nerve system and that providing~     appropriate stimuli encourages these changes. It was found that stimulation of rhythm,~     stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve~     system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive,~     rhythm) may influence the autonomic nervous system and cause an increase in brain activity,~     therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose~     of this study is to examine the influence of stimulation of rhythm, stimulation of~     cognition, stimulation of activity and combined stimulation, on the autonomic nerve system.~     This effect will be tested by measuring heart rate variability in chronic stroke patients~     and in a control group.~   "
3117|NCT03016403|"~     Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally~     encounter significant disparities in accessing care for their mental health needs while~     undergoing toxic treatments that provide considerable physical and emotional stress. Thus,~     the investigators propose to adapt evidence-based strategies to a stepped-care intervention~     model to address the mental health needs of under-served lung cancer (LC) and head and neck~     cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g.,~     mild, moderate, or severe symptoms of depression and anxiety).~   "
3118|NCT03016390|"~     Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of~     patients with it are growing rapidly. Electromagnetic interference causing device~     malfunction is not uncommon, Radiofrequency Identification system is among its plausible~     source. Patients with CIEDs are at risk of exposure to this novel product in their daily~     living especially automobile keyless access system. Only informal studies have been~     conducted and not be published. Formal and systemic evaluation and tests are crucial.~   "
3119|NCT03016377|"~     This research study combines two different ways of fighting disease: antibodies and T cells.~     Both antibodies and T cells have been used to treat patients with cancers. They both have~     shown promise, but neither alone has been sufficient to cure most patients. This study is~     designed to combine both T cells and antibodies in order to create a more effective~     treatment. The treatment that is being researched is called autologous T lymphocyte chimeric~     antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration.~      In previous studies, it has been shown that a new gene can be put into T cells that will~     increase their ability to recognize and kill cancer cells. The new gene that is put in the T~     cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to~     leukemia cells because they have a substance on the outside of the cells called CD19. For~     this study, the anti-CD19 antibody has been changed so that instead of floating free in the~     blood part of it is now joined to the T cells. When an antibody is joined to a T cell in~     this way it is called a chimeric receptor. These CD19 chimeric (combination)~     receptor-activated T cells seem to kill some of the tumor, but they do not last very long in~     the body and so their chances of fighting the cancer are unknown.~      Preliminary results have shown that many subjects receiving this treatment have experienced~     unwanted side effects including cytokine release syndrome. In this study, to help reduce~     cytokine release syndrome symptoms, the ATLCAR.CD19 cells have a safety switch that when~     active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the~     safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to~     severe cytokine release syndrome as a result of being given iC9-CAR19 cells, then the~     subject may take part in a sub-study where you will be given a second study drug, AP1903.~     AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in~     the blood. The goal of the sub-study is to determine what dose of AP1903 can be given that~     reduces the severity of the cytokine release syndrome to mild, but still allows the~     remaining iC9-CAR19 cells to effectively fight the leukemia.~      The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe~     and tolerable and to determine an optimal dose of AP1903 to be given to subjects to~     alleviate severe cytokine release syndrome.~   "
3120|NCT03016364|"~     The purpose of this trial is to determine whether Application (APP) would help clinical~     doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced~     patients with cancer pain.~   "
3121|NCT03016351|"~     After the participant meets all inclusion and exclusion criteria, they will be randomized~     equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both~     groups will participate in an 8 week initial control period, followed by 8 weeks of~     supervised exercise training, followed by 8 weeks of deconditioning. All participants will~     undergo the same assessments and procedures one time prior to the initial 8 week control~     period, and at each of the three periods. Assessments include: blood draws; arterial~     stiffness testing; ultrasounds of the brachial artery to measure flow-mediated dilation~     (FMD); gluteal adipose tissue biopsies; exercise testing to determine VO2 max; body~     composition analysis via DEXA scans; ambulatory blood pressure measurement; diet analysis~     via food journals; medical history questionnaires; urine analysis for pregnancy; and~     activity monitoring via accelerometer. Total participation will be 24-26 weeks.~   "
3122|NCT03016338|"~     This is a phase 2 study of investigational drug niraparib in patients with~     advanced/recurrent endometrial cancer. The purpose of this study is to determine whether~     blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides~     clinical benefit in patients with recurrent endometrial cancer, as well as to explore the~     possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN~     gene) on blocking PARP with niraparib.~   "
3123|NCT03016325|"~     A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO~     Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function~   "
3124|NCT03016312|"~     This Phase III, multicenter, randomized, open-label study will evaluate the safety and~     efficacy of atezolizumab in combination with enzalutamide compared with enzalutamide alone~     in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g.,~     abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants~     will receive treatment until investigator-assessed confirmed radiographic disease~     progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.~   "
3125|NCT03016299|"~     The subchondral bone, formed by the subchondral bone plate and the subarticular spongiosa,~     plays a key role in supporting the articular cartilage. Marrow stimulation techniques such~     as subchondral drilling are clinically important treatment options for symptomatic small~     cartilage defects. However, The heat generated from the metal-bone interface during drilling~     due to the friction can cause thermal osteonecrosis. , recent clinical evidence suggests~     that they may induce alterations in the subchondral bone plate such as intralesional~     osteophytes, which persist and may play a role in the degeneration of the repair tissue.~      Little is known about whether they induce deleterious changes in the Human Chondral &~     Subchondral bone.~      The aim of this study was to compare the condral & Sub-chondral Histoligical damage induced~     by different drilling techniques.~      To the best of our knowledge this is the first time to inspect it, In- Situ, on Human~     tissue.~   "
3129|NCT03016247|"~     The purpose of this pilot study is to evaluate the effect of the Trust-building weight~     Self-management Together (TRUST) intervention on weight self-management behaviors and neural~     processing in overweight/obese adolescents. Study aims include comparing the effects of the~     TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese~     early adolescents and exploring differences in neural processing (DMT/TPN switching and~     reward activation).~   "
3130|NCT03016234|"~     This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on~     surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to~     compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients~     undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized~     controlled trial. The patients were randomly assigned to desflurane or propofol~     administrated groups and all patient are administered intravenous remifentanil continuously~     as adjuvant analgesics during anesthesia. For this study 50 to 80-year-old patients~     undergoing laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial~     blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen®~     Avia tonometer) on both eyes were measured at defined intervals during the procedure.~   "
3131|NCT03016221|"~     The use of topical over-the-counter (OTC) products with a warming or cooling effect is~     widespread in the fields of sport, physiotherapy and in private households. Advertisements~     for such products promise pain relief when suffering from musculoskeletal disorders such as~     muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only~     little information about the efficacy and the physiological mechanisms of topical warming or~     cooling products. Therefore, the aim of this study is to investigate the local skin~     characteristics during and after an application of a topical product with a warming or~     cooling effect.~   "
3132|NCT03016208|"~     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for~     labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.~      Design: Non-interventional observational case control study.~      Setting: Tertiary-care academic centre in Germany.~      Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.~      Methods: Induction of labour with MVI in a consecutive series of women using standard~     (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.~      Main outcome measures: The primary outcomes were the time from induction to delivery and the~     caesarean section rate. The secondary outcomes included the need for additional measures to~     induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained~     amniotic fluid, umbilical arterial pH, and Apgar score.~   "
3133|NCT03016195|"~     Oral sodium supplementation is currently administered in cases of poor weight gain in~     infants particularly in patients who have undergone gastrointestinal surgical procedures.~     The decision to start oral supplementation is based on urinary sodium levels although the~     level at which to start treatment is variable as the range in normal, healthy infants is~     unknown. This study aims to ascertain the normal range of sodium in urine specimens~     collected from healthy newborn babies.~      It is believed that by increasing the level of salt in the intestine, glucose can be more~     easily be absorbed and therefore weight gain improved. Babies with conditions where they are~     at risk of salt depletion (i.e. those with a stoma) are currently administered oral sodium~     supplementation if they are failing to gain weight and have an associated 'low' urinary~     sodium level. Low levels of urinary sodium are considered to represent a state of low body~     sodium levels, as the kidneys attempt to reabsorb most of the sodium in the urine before it~     is excreted.~      Current practice varies widely as to the level below which treatment should be instigated.~     Some centres advise below 20 mmol/L (Birmingham Children's Hospital and Nottingham~     Children's Hospital guidelines), others below 10 mmol/L (University Children's Hospital,~     Zurich). In Glasgow, babies with poor weight gain are given sodium supplementation if~     urinary sodium levels are below 40 mmol/L. There are no documented ranges for the levels of~     urinary sodium in healthy, newborn babies.~      By determining the reference range of urinary sodium levels in healthy, term babies who are~     gaining weight appropriately, the investigators hope to be able to have a better~     understanding about both the level below which supplementation should be considered and the~     target range that should be aimed for.~   "
3134|NCT03016182|"~     During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a~     problem complicating the postoperative course of the patients.Remote ischemic~     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,~     cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that~     RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the~     RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is~     still uncertain.~      The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect~     and improve clinical outcomes in patients undergoing cardic surgery.~   "
3135|NCT03016169|"~     The objective of this study is to evaluate the safety and performance of the Trifecta™ GT~     (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world~     setting. This study is intended to satisfy post-market clinical follow-up requirements of CE~     Mark in Europe.~   "
3136|NCT03016156|"~     This study seeks to determine whether a smartphone application called CRADLE (ComputeR~     Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria.~     There will be no impact on participants' health outcome.~      This study will be performed in two parts, each with a distinct cohort of patients.~      Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within~     patients known to have leukocoria.~      Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using~     the techniques selected from information gathered in Part 1) as compared to an~     ophthalmoscope, within patients referred to the clinic for suspected leukocoria.~      PRIMARY OBJECTIVES:~        -  To determine the most effective usage of a camera phone application (CRADLE) to~          maximize detection of leukocoria in patients with retinoblastoma, congenital cataracts,~          and glaucoma.~        -  To estimate the sensitivity and specificity of a camera phone application (CRADLE) in~          detecting leukocoria.~   "
3137|NCT03016143|"~     The study is a single centre, phase II, double-blind, randomized, comparative trial that~     explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal~     influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18~     to 60 years of age and older than 60 years).~   "
3138|NCT03016130|"~     This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a~     liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in~     patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and~     common sense advice listed in the FDA-endorsed food safety guidelines.~   "
3139|NCT03016117|"~     The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during~     quadrantectomy with or without axillary dissection, in breast cancer surgery~   "
3140|NCT03016104|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety for bipolar mania. Half of the participants will receive MST, while the other~     half will receive electroconvulsive therapy (ECT).~   "
3141|NCT03016091|"~     A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and~     Anaplastic Meningioma~   "
3142|NCT03016078|"~     The overall rationale for this investigation is to evaluate the clinical performance~     potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related~     post-operative wound complications such as blistering, maceration and redness at the~     incision and surrounding skin.~   "
3143|NCT03016065|"~     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber~     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota~     composition and activity.~   "
3144|NCT03016052|"~     this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in~     response to deviations from the embedded contingency in attention bias modification~     treatment (ABMT) for social and generalized anxiety, and the interaction between vMMN~     emergence and clinical improvement.~   "
3145|NCT03016039|"~     To use curcumin supplementation as an additive treatment to induce clinical, biochemical~     response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian~     abcess, Endometritis, wound infection.~      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound~     infection patients may augment clinical and biochemical response and accelerates the~     improvements of the sign symptoms and reported outcomes of those diseases.~   "
3146|NCT03016026|"~     This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS)~     on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS~     program.~   "
3147|NCT03016013|"~     The purpose of this study is to initially access the safety and effectivity of RC18 combined~     with methotrexate (MTX) in comparison with the use of methotrexate alone in participants~     with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX~     therapy.~   "
3148|NCT03016000|"~     This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide~     maintenance therapy to prolong relapse-free survival in diffuse large B cell~     lymphoma(DLBCL).~   "
3149|NCT03015987|"~     the investigator intended to study the effect of laser versus ultrasonic in activation of~     irrigation in post operative pain of patients have a symptomatic necrotic teeth~   "
3150|NCT03015974|"~     This study tries to identify the safe and effective treatment option for IgA nephropathy in~     children. Investigators will perform prospective registration study among 25 pediatric~     nephrology medical centers in China.~   "
3151|NCT03015961|"~     Primary Objective: The primary objective of this study is to compare postsurgical pain~     control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine~     HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar spinal fusion~     surgery.~      Secondary Objectives: The secondary objectives of this study are to compare additional~     efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with~     bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar~     spinal fusion surgery.~   "
3152|NCT03015948|"~     This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose~     Phase I trial.~   "
3153|NCT03015935|"~     Laparoscopic surgery has become very popular and standard in many indications after~     advancements of technique. Various methods have been used in first entry to the abdomen.~     Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are~     important. Several techniques, instruments, and approaches to minimize the risk of injury~     (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have~     been introduced.~      There is no consensus yet on an optimal method has yet emerged.~      The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of~     the first trocar at any site of the abdomen.~      To evaluate the efficacy of entry technique, the investigators used cohort of patients who~     will be planned to laparoscopic obesity surgery.~      Two methods are commonly used in surgical literature and in our center.~      The investigators have been used visible optical-entry technique in some patients for first~     entry and Veress technique in some other patients.~      For this purpose, the investigators designed an observational study.~   "
3154|NCT03015922|"~     This study will recruit patients currently receiving either lenalidomide or pomalidomide~     whose disease is relapsing. This is a dose escalation study and the aim is to determine the~     maximum tolerated dose (MTD) of REOLYSIN® that can be given in combination with lenalidomide~     or pomalidomide. The study will also investigate the safety, side effects and effectiveness~     of this treatment combination. Pomalidomide and lenalidomide will be evaluated separately as~     two separate groups.~   "
3155|NCT03015909|"~     The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks~     subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant~     human growth hormone by reusable device.~   "
3156|NCT03015896|"~     This I/II trial studies the side effects and best dose of lenalidomide when given together~     with nivolumab and to see how well they work in treating patients with non-Hodgkin or~     Hodgkin lymphoma that has come back and does not respond to treatment. Monoclonal~     antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and~     spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving nivolumab and lenalidomide may work better in treating~     patients with non-Hodgkin or Hodgkin lymphoma.~   "
3157|NCT03015883|"~     A unique approach for cancer treatment employing intratumoral diffusing alpha radiation~     emitter device.~   "
3158|NCT03015870|"~     Many detrimental effects of aging have been identified in the human voice, most of which are~     accepted as normal. However, age-related vocal deficits disrupt communication and decrease~     quality of life in older adults and may be preventable and/or treatable through behavioral~     interventions. The objective of this proposal is to determine the effectiveness of a~     technology-assisted vocal exercise intervention on the vocal function and quality of life in~     older adults. Forty older adults (65+) will be recruited and randomly assigned to either an~     app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing~     involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive~     functioning assessments will be conducted. This interdisciplinary project will enhance the~     investigators understanding of physical, mental, and social health-related quality of life~     among older adults.~   "
3159|NCT03015857|"~     Hypotension following spinal anesthesia for cesarean section is a serious problem. In this~     study we investigated the effect of the vasopressors phenylephrine and noradrenaline on~     postspinal hypotension.~   "
3160|NCT03015844|"~     This is an expanded access protocol/compassionate use single institution study designed to~     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive~     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher~     priority. Response rate, toxicity, and time to progression and death will be evaluated.~   "
3161|NCT03015831|"~     The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the~     incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test~     0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.~   "
3162|NCT03015818|"~     Structural valve dysfunction (SVD) is the most common and life threatening complication in~     patients treated by aortic valve replacement. A calcification process is frequently involved~     in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic~     phenomenon of calcification, as previously shown in native aortic valve stenosis, rather~     than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging~     with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.~      This study will include patients with echocardiography-confirmed SVD. Echocardiographic~     parameters and other current parameters analyzed in SVD patients such as bioprosthesis~     calcium scoring derived from CT will be compared to 18F-Fluoride activity.~   "
3163|NCT03015805|"~     The purpose of this study is to examine the effectiveness of Juvenile Probation Officers~     (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems~     with drug use. CM has already been shown to be effective at helping teens with drug problems~     but CM has never been delivered by JPOs. This study will test how well it works to have JPOs~     deliver CM during their regular meetings with teens.~   "
3164|NCT03015792|"~     This phase I/II trial studies the best dose and side effects of ibrutinib when given~     together with lenalidomide and dexamethasone and how well they work in treating patients~     with multiple myeloma that are not eligible for transplant. Ibrutinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work~     better in treating patients with multiple myeloma.~   "
3165|NCT03015779|"~     The aim of this trials investigates the therapeutic effects of application autologous oral~     mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.~   "
3166|NCT03015766|"~     Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent~     years and yielded favorable results. However, the effect and safety of AAT for insomnia in~     MHD population still lacks high quality evidence. A randomized controlled clinical trial is~     planned to evaluate the effect and safety of AAT in MHD patients with insomnia.~   "
3167|NCT03015753|"~     The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on~     the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility,~     acceptability, compliance and maintenance of Tai Chi exercise among this population.~   "
3168|NCT03015740|"~     The goal of this clinical research study is to find the highest tolerable or recommended~     dose of MGCD5 that can be given with nivolumab to patients with kidney cancer. Researchers~     also want to learn if this dose can help to control the disease. The safety of this drug~     combination will also be studied.~   "
3169|NCT03015727|"~     In this study, the investigators aim to compare the progression-free survival (PFS) and side~     effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally~     advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response~     (complete response or partial response) after neoadjuvant chemotherapy (NACT).~   "
3170|NCT03015714|"~     Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in~     Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation~     treatment.~   "
3171|NCT03015701|"~     To compare daily oral mifepristone vs placebo with respect to time to treatment failure in~     patients with unresectable meningioma.~   "
3172|NCT03015688|"~     It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of~     osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine~     whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee~     OA cases were collected from the first affiliated hospital of Shihezi university and healthy~     controls were recruited from the community. The severity of knee OA was defined as~     kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were~     compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The~     serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .~   "
3234|NCT03014882|"~     Accumulation of iron in patients with beta thalassemia major causes free radical formation~     which leads to damage of biological membranes. Sperm DNA damage may result from these~     generated antioxidants.~      We aimed at investigating the current DNA damage in the sperms of adult patients with beta~     thalassemia major and the effect generated by giving antioxidant treatment for 6 months.~   "
3785|NCT03007680|"~     The purpose of this study is to determine whether core muscle activation is effective in the~     increase of quality of cardiopulmonary resuscitation.~   "
3173|NCT03015675|"~     Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high~     dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high~     dose vitamin C usage could significantly prolong overall survival of patients with advanced~     cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring~     KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High~     dose of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials~     have found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients.~     This protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment~     with mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or~     advanced gastric cancer.~   "
3174|NCT03015662|"~     Objectives: The purpose of the current randomized clinical trial is to compare the~     effectiveness of dry needling versus myofascial release therapy on myofascial trigger points~     (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and~     depression in patients with fibromyalgia syndrome (FMS).~   "
3175|NCT03015649|"~     The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast~     Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.~     The device is a non-wire system, which uses nonradioactive light-activated radar, to provide~     breast surgeons with real-time guidance to locate and remove the target lesion in the breast~     and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days~     prior to surgery to assist surgeons in the localization and retrieval of breast/axillary~     lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this~     study, investigators will assess the longer term placement of the SCOUT device over an~     extended time (31 - 365 days) in order to address the needs of patients who require~     neoadjuvant treatment prior to definitive surgery.~   "
3176|NCT03015636|"~     Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many~     patients in psychiatric care have sleep problems including insomnia, but are rarely given~     the choice to participate in CBT to improve their sleep. Patients with ADHD is a patient~     group with high levels of sleep difficulties. Sleep problems in this patient group can be~     both more general such as insomnia, but can also be related to the ADHD itself and to the~     use of ADHD medication. In a previous pilot study, the investigators developed a version of~     CBT-i that would target sleep problems in this population. The basis was CBT-i, but with~     more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of~     ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the~     systematic use of light and darkness), and techniques to target more general sleep~     disturbing habits (e.g. not winding down before bed time), that are also common in patients~     with ADHD. This treatment was well tolerated and gave moderate effects on insomnia severity~     in the pilot study. In a naturalistic randomized controlled trial, the investigators now~     evaluate the effects of this psychological treatment on sleep and symptoms of ADHD in~     patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.~   "
3177|NCT03015623|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     product, SBI-101, in subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device~     combination product designed to regulate inflammation and promote repair of injured tissue~     using allogeneic human mesenchymal stromal cells. Patients will be randomized to receive one~     of three treatments, low dose SBI-101, high dose SBI-101, or sham control. SBI-101 will be~     integrated into the renal replacement circuit and patients will be treated for up to 24~     hours.~   "
3178|NCT03015610|"~     This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of~     lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It~     will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and~     asthma control.~   "
3179|NCT03015597|"~     The purpose of this study is to see whether contingency management (CM) can be successfully~     added as an adjunct treatment to standard stop smoking services in outpatients undergoing~     treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for~     opiate addiction will be stratified to a CM intervention for either smoking abstinence or~     attendance at the clinic, whilst also receiving usual stop smoking services cessation~     treatment. The intervention will run for five weeks and participants will be followed up six~     months after the beginning of the study.~   "
3180|NCT03015584|"~     This study will use systems biology techniques, especially RNA-seq, to understand cognitive~     impairment after sepsis requiring an intensive care unit (ICU) admission.~   "
3181|NCT03015571|"~     The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely~     used during esophagus inspection at diagnostic gastroscopy.~   "
3182|NCT03015558|"~     The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the~     opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in~     both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia~     by tDCS will be assessed using both laser stimuli and cold pressor test. In patients the~     assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain,~     sleep and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode~     montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior~     insular cortex). In patients, three separate conditions (two active and one sham) will be~     tested in randomised order. In healthy subjects, two other conditions are added to control~     for attention and distraction confounders.~   "
3183|NCT03015545|"~     Whole body vibration is an exercise modality that could modulate tissue blood perfusion and~     neural reflexes, and thus may have the potential to alter muscle stiffness through~     modulation of contractile properties or/and neurological adaptation. However, the potential~     effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. The overall~     aim is to investigate the effects of whole body vibration (WBV) on leg muscle stiffness and~     Hoffman reflex (H-reflex) and to identify the optimal vibration parameters that may reduce~     leg muscle stiffness among people with stroke.~   "
3184|NCT03015532|"~     This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,~     multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to~     evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered~     via infiltration to the surgical site.~   "
3786|NCT03007667|"~     To investigate the changes in the anatomical location of ureters after colorectal surgery.~   "
3185|NCT03015519|"~     The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment~     options are limited in children and adolescents. Albiglutide, approved for the treatment of~     T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a~     sufficiently long half-life to permit once a week injection. The study will be conducted in~     2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety~     of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a~     randomized double-blind placebo controlled study to evaluate the safety and efficacy~     (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B~     is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which~     all subjects will receive albiglutide). Approximately 210 eligible male and female subjects~     will be included in the study.~   "
3186|NCT03015506|"~     The objective of this study is to determine the glycemic index of 4 pulse-based breads in at~     least 10 normal healthy human volunteers. Participants will be studied in the morning on 6~     separate days after overnight fasts. On the first and last days they will consume a test~     meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days~     they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing~     starch obtained from pulses (beans and/or lentils). Blood glucose will be measured at~     intervals over 2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the~     incremental area under the curve of blood glucose (AUC) after each test bread and WB is the~     mean AUC after white bread.~   "
3187|NCT03015493|"~     The purpose of the study is to examine the effects of cervical traction with or without the~     addition of neural mobilization, in patients with cervical radiculopathy~   "
3188|NCT03015480|"~     This study will test the effectiveness of remotely delivered medical nutrition therapy~     (MNT), focused on increasing fruit/vegetable intake, and decreasing sodium and red/processed~     meat intake, in the treatment of patients with stage 1-2 chronic kidney disease (CKD) and~     diabetes.~   "
3189|NCT03015467|"~     Severe acute pancreatitis is an acute and rapid progress of the digestive system~     disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier~     dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play~     an important role in the development process in the course of severe acute pancreatitis. At~     this stage of the study that infection of pancreas and other organs is the leading cause of~     death in patients with severe acute pancreatitis，and the main pathogens from intestinal~     micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota~     Transplantation that has been used for treatment of inflammatory bowel disease and~     Clostridium difficile infection may be a new technology for regulation of intestinal mucosal~     dysfunction and intestinal flora unbalance.~   "
3190|NCT03015454|"~     A sepsis early warning predictive algorithm, InSight, has been developed and validated on a~     large, diverse patient cohort. In this prospective study, the ability of InSight to predict~     severe sepsis patients is investigated. Specifically, InSight is compared with a well~     established severe sepsis detector in the UCSF electronic health record (EHR).~   "
3191|NCT03015441|"~     The purpose of this study is to assess the effect of a 28-day fermented milk product~     consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in~     healthy subjects high H2 producers.~   "
3192|NCT03015428|"~     This study aims to experimentally evaluate the training program for family caregivers of~     people with dementia_Living together with Dementia.~   "
3193|NCT03015415|"~     This study compares patients with post traumatic elbow stiffness and evaluate the range of~     motion improvement with two types of treatment: surgical release versus non-surgical~     rehabilitation protocol with orthoses.~   "
3194|NCT03015402|"~     The main objective of this study is to determine the clinical efficacy of oral inorganic~     nitrite verses placebo and the therapeutic response with regards to exercise tolerance in~     patients with pulmonary hypertension and heart failure with preserved ejection fraction~     (PH-HFpEF).~   "
3195|NCT03015389|"~     This is a multi-center, prospective, randomized study which will enroll patients undergoing~     endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of~     the research team will approach a potential subject to discuss participation in the study,~     including background of the proposed study, inclusion and exclusion criteria, benefits and~     risks of the procedures and follow-up. If this is of interest to the subject, the informed~     consent form is discussed and presented. The subject must sign the consent form prior to~     enrollment. This form will have prior approval of the study site's Institutional Review~     Board (IRB). Failure to obtain informed consent renders the subject ineligible for the~     study.~   "
3196|NCT03015376|"~     Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and~     mismatch repair genes in patients with epithelial ovarian cancer (EOC) and their relatives,~     and related somatic mutations in tumor tissues in the northern part of china.~      Patients and methods: A multicenter prospective study will be hold in the northern part of~     china form 2017. About 1000 female patients with epithelial ovarian cancer and their~     ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes~     and related somatic mutations in tumor tissues, regardless of the family history.~      Study type: Observational Official title: Prevalence study of germline mutations in~     susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic~     mutations in their tumor tissures in the northern part of china.~      Enrollment: 1000~   "
3197|NCT03015363|"~     The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate~     and validate a novel, non-invasive wrist cuff blood pressure device against the gold~     standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented~     patient participants who are scheduled for an elective cardiac catheterization procedure for~     clinically valid reasons.~   "
3235|NCT03014869|"~     For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard~     therapy, which can reduce the rate of intubation and mortality. A few previous studies have~     shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some~     severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for~     preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis,~     we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate~     AECOPD patients.~   "
3198|NCT03015350|"~     16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will~     recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply~     in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two~     lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be~     performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will~     given from patients. Blood sample will be taken at intervals of 10 minutes from groups of~     two lung ventilation. In groups of one lung ventilation, blood samples will be taken at the~     time interval of 10 minutes after one lung ventilation started. All blood samples will be~     assess in Gas Chromatography.~   "
3199|NCT03015337|"~     This study examined how well elementary students demonstrated motor skill competency as a~     result of participating in the evidence-based quality physical education program and~     investigated relationships between levels of health-related physical fitness and physical~     activity in school-aged children.~   "
3200|NCT03015324|"~     Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary~     surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).~     Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.~     Subjects will receive HCQ every day.~   "
3201|NCT03015311|"~     The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a~     2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The~     purpose of this trial is to test whether a treatment program aimed at reducing systolic~     blood pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently~     recommended (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80~     years of old. Furthermore, this trial will also examine the effect of blood pressure APP~     management strategy via WeChat network on medication compliance, blood pressure control and~     CVD benefits.~   "
3202|NCT03015298|"~     The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be~     compared.~   "
3203|NCT03015285|"~     Adults with high anxiety sensitivity (AS) and a mental health diagnosis of anxiety,~     depression, or posttraumatic stress will be recruited and will be randomly assigned to~     either transdiagnostic cognitive behavioural therapy (CBT) for AS or disorder-specific CBT~     for their primary mental health problem. The study outcomes - AS, anxiety, mood, and~     substance use symptoms, and functional impairment - will be assessed at pre-and~     post-treatment and 6 and 12 months post-treatment via standardized self-report measures~     completed by participants and a standardized diagnostic interview.~   "
3204|NCT03015272|"~     The goal of the Novel Language Intervention for minimally verbal children with Autism~     Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT)~     compared to baseline assessments and compare the AMMT efficacy to a control intervention~     (SRT), both treatments were designed to facilitate speech output in minimally verbal 5.5 to~     12.0 year olds. This study aims to compare the two interventions (one intonation-based; the~     other non-intonation-based) in a single-blind, randomized controlled trial (RCT) that~     includes a comprehensive baseline assessment battery, 25 intensive 1-on-1 treatment sessions~     conducted 5 days/week, and a series of probe assessments administered at multiple timepoints~     pre-, during, and post-therapy.~      Despite the complex needs of minimally verbal children with ASD and the wide variety of~     treatments available to address many of those needs, there is still a great need for~     effective methods that promote the development of speech sounds and facilitate the~     production of those sounds in this growing population. While the primary aim of this RCT is~     to investigate the effects of AMMTversus a control intervention (SRT) on minimally verbal~     children with ASD and compare the two interventions to determine whether one is more~     effective than the other, this study also aims to examine whether baseline cognitive skills,~     speech praxis, joint attention abilities and/or neural architecture can predict the effects~     of treatment with AMMT or SRT in minimally verbal children with ASD.~   "
3205|NCT03015259|"~     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week~     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide~     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation~     aerosol.~   "
3206|NCT03015246|"~     This research deals with behaviors that are part of opioid dependence. The purpose is to~     study how stress and medication dose can affect opioid drug use.~   "
3207|NCT03015233|"~     Abdominal pain is one of the most common reasons for consultation in Emergency Departments~     (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The~     actual gold standard for diagnosis is computed tomography (CT). However with this procedure~     there is high radiation exposure and a risk factor of radiation-induced cancers, therefore~     alternative diagnostic techniques should be considered. The aim of this study is to evaluate~     the performance of measuring venous lactate in patients presenting with acute abdominal pain~     in ED.~      In this single-center, prospective, non-interventional study, the diagnostic accuracy of~     venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made~     here is that venous lactatemia is a positive predictive factor of surgical emergencies in~     patients with acute abdominal pain.~   "
3208|NCT03015220|"~     This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy~     of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic~     drug) in Japanese subjects with type 2 diabetes.~   "
3209|NCT03015207|"~     This trial is conducted in The United States of America. The aim of this trial is to~     investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the~     body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.~   "
3230|NCT03014934|"~     Via a prospective non-interventional study clinical outcome of patients with - and without -~     history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in~     terms of non-relapse mortality overall mortality and fungal infectious morbidity.~      Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of~     pre-existing IA vs. no pre-existing IA.~      Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of~     10%) than patients without pre-existing IA.~      Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell~     grafts.~      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of~     probable or proven invasive aspergillosis: this cohort includes also the patient with a~     history of possible mycosis not documented microbiologically.~   "
3210|NCT03015194|"~     Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure~     when no surgical options exist. In as many as half of patients, TMVR can cause~     life-threatening blockage of the left ventricle by displacing the existing mitral valve~     leaflet. For these patients the only options appear to avoid TMVR or in some to cause a~     focused heart attack and to wait 6 weeks. The investigators have developed and tested a~     technique to tear the existing mitral valve leaflet and enable TMVR in patients who have no~     other options. The procedure is called intentional laceration of the anterior mitral leaflet~     to prevent left ventricular outflow tract obstruction (LAMPOON). Although there are no~     dedicated TMVR devices commercially available, there has been short-term success with~     implanted transcatheter aortic valve devices in the mitral position for TMVR.~      The purpose of this study is to perform LAMPOON and TMVR in patients who have no good~     options to treat their mitral valve failure, using heart valve devices designed to implant~     in the aortic valve position.~   "
3211|NCT03015181|"~     This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb)~     in healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability,~     dose, and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe~     for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.~      Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations~     of VRC07- 523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2~     open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and~     Groups 6-7 are expected to enroll 5 sjubjects. Subjects will be followed for 24 weeks after~     the last study product administration.~   "
3212|NCT03015168|"~     We explored the relationship between NLR and grade 3 or higher treatment related small bowel~     toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and~     concurrent intensity modulated radiotherapy (IMRT).~   "
3213|NCT03015155|"~     Recent clinical studies have shown that systemic therapeutic hypothermia improving the~     outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary~     percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have~     described the methods, mechanism and rationale of therapeutic hypothermia, including local~     myocardial hypothermia. However, little is known of the local myocardial hypothermia having~     impact on prognosis of the patients with acute myocardial infarction. The aim of this study~     is to ascertain whether local myocardial hypothermia is effective in treatment of~     ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.~   "
3214|NCT03015142|"~     There is a clear need in spine surgery to place pedicle screws in the right place in the~     spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots~     or vertebral arteries). The objective of the study is to investigate the accuracy of screw~     placement during spine surgery.~   "
3215|NCT03015129|"~     This study will test the safety and efficacy of the experimental drug called durvalumab with~     or without another experimental drug called tremelimumab in endometrial cancer.~   "
3216|NCT03015116|"~     BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,~     results in pain-related disability in Service Members and beneficiaries and contributes to~     decreased physical activity and excessive healthcare costs. Even if effective, current~     treatment protocols may require 6-12 months of therapy to return individuals to pain-free~     activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to~     elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence~     supports use of PBM for other degenerative connective tissue conditions, such as Achilles~     tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of~     plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive~     on its clinical effectiveness.~      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in~     conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the~     clinical effectiveness of photobiomodulation in conjunction with and compared to usual care~     to improve function and decrease pain and in patients. 3. Assess the difference between two~     photobiomodulation dose parameters in conjunction with and compared to usual care for~     plantar fasciitis treatment.~      DESIGN: The investigators will use a prospective randomized controlled trial to meet the~     aims of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries~     will be randomly assigned to either usual care, usual care plus PBM lower dose, or usual~     care plus PBM higher dose groups. At baseline, during the treatment protocol, and at long~     term (3 and 6 month) follow-up, measures of foot function and pain will be collected for~     analysis. The proposed methods will allow the study team to establish if PBM accelerates~     recovery compared to usual care, as well as determining the optimal dose for future trials~     comparing PBM to other, more invasive, therapies for plantar fasciitis.~   "
3217|NCT03015103|"~     The purpose of this study is to prove the product tested does not cause photoirritation or~     photosensitization reactions when exposed to sun light.~   "
3218|NCT03015090|"~     The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect~     metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary~     disease patients.~   "
3219|NCT03015077|"~     The rapidly increasing mortality and incidence of oral cancer has become a public health~     major problem in Taiwan. To date, the treatment of head and neck cancer mainly include~     surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an~     influence on the patients' diet by causing dismal side effects, including nausea, vomiting,~     pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the~     patients more difficult to absorb nutrients. In the previous study, the incidence of~     malnutrition among the patients with cancer has been estimated at between 40 and 80%,~     especially occurred in the patients with head and neck cancers and upper gastrointestinal~     cancers.~      In this study, the effect of supplement with L-Glutamine on the nutritional status and~     radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the~     patients' quality of life when they are undergoing radiotherapy. When the head and neck~     cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of~     L-Glutamine are performed to maintain the patients' nutritional status and reduce the~     patients' diet-related or other side effects caused by radiotherapy. It is anticipated that~     head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might~     decrease treatment-related side effects and hence improve their quality of life when they~     are undergoing radiotherapy.~   "
3220|NCT03015064|"~     Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the~     diagnosis of the first acute myocardial infarction from July 2016 until December 2020.~   "
3232|NCT03014908|"~     The aim of this study was to look for discriminating variation in the concentrations of~     small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched~     controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.~   "
3221|NCT03015051|"~     Bronchiolitis is the most common respiratory infection of the lower respiratory tract that~     affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with~     bronchiolitis require hospital admission because of poor feeding and/or breathing~     difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and~     hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of~     the techniques of administration of oxygen in bronchiolitis is represented by the high flow~     (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC~     provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces~     breathing load and allows for better nutrition. The main aim of therapy with high flows is~     to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there~     have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review~     on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a~     pilot study of 19 subjects comparing HFNC with oxygen administered via head box. The~     oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours~     (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the~     available evidence is insufficient to determine the effectiveness of HFNC.~      The aim of this study is to evaluate in a large number of cases the effectiveness of~     treatment with high flow versus standard treatment, in children with bronchiolitis referred~     to a Pediatric Emergency Department.~   "
3222|NCT03015038|"~     Duration of each part of the study per patient:~        -  Screening: From 1 to 4 weeks~        -  Sampling period (blood and tissue): 1 day~        -  Follow-up by patient: 60 months~        -  Total study duration by patient: 84 months~        -  Total inclusion duration: 24 months~        -  Total Follow-up duration: 60 months~        -  Total study duration: 84 months~   "
3223|NCT03015025|"~     The use of coumarins has been a challenge for doctors because of its narrow therapeutic~     range and they show great inter and intra-individual variability in the dose necessary to~     achieve an international normalized ratio (INR) within the therapeutic range. Among the~     factors influencing the interindividual variability in the dose required include age,~     weight, Vitamin K in the diet, comorbidity as well as drug interactions and in recent years~     has also seen the importance of pharmacogenetic factors.~   "
3224|NCT03015012|"~     The investigators hypothesize that compared to the provision of population-based dietary~     advice, providing DNA-based dietary advice via personalized nutrigenomics testing (PNT) to 2~     distinct patient populations (prediabetes patients and transplant recipients) will motivate~     them to adopt healthier dietary habits, lead to greater fat loss, increased percent lean~     mass and therefore improve health and quality of life outcomes for both patient populations.~     The second hypothesis is that dietary strategies related to the intake of one or more~     dietary components of interest will mitigate post-transplant weight gain associated with~     three SNPs of interest.~      This is a randomized clinical intervention trial involving a total of four groups of~     patients (n = 300). The two main patient groups include overweight or obese stable~     transplant recipients and overweight or obese patients who have been diagnosed with~     prediabetes. Within these two main groups, there will be two sub-groups. Patients in each of~     the two main groups will be randomized to receive either PNT or standard nutrition~     intervention (SNI). Baseline data will be conducted consisting of a 24-hour recall and 3-day~     food records using a validated multiple pass method. Bioelectrical Impedance Analysis (BIA)~     will be conducted to assess body composition and to derive percent body fat and lean mass.~     Weight and height will be measured using a weigh scale and stadiometer. Those patients~     randomized to the PNT group will be instructed on a tailored nutrition care plan based on~     their individual nutrigenomics profile. At the same time, the SNI group will be instructed~     on general nutrition recommendations for weight loss using the standard tool ('Just the~     Basics') used by registered dietitians for transplant patients and prediabetes patients.~     Monthly email reminders will be sent to all participants as a reminder of their nutrition~     plan. 6-months after baseline data collection and individual nutrition interventions,~     baseline data will be repeated. After the study is complete, participants in the SNI group~     will be offered a nutrigenomics test and consultation with a registered dietitian.~      A paired t-test will be used to assess within group change from baseline to 6-month~     follow-up for: BMI, body fat, lean mass, and dietary intake. A repeated measures ANOVA will~     be used to test between group differences from baseline to 6-month follow-up for: BMI, body~     fat, lean mass, and dietary intake. If significant mean differences are detected, a Tukey's~     post hoc test will be used to compare differences by group. Statistical significance will be~     determined by P < 0.05. General linear regression models will be used to assess interactions~     between each genotype of interest and each dietary component of interest on BMI and body~     composition from baseline to 6-month follow-up.~   "
3225|NCT03014999|"~     A crossover trial with spinal cord injury volunteers will be conducted. Three sessions will~     be performed once a week in a counterbalanced order and at least with seven days washout~     period to minimize carry-over effects. In each session, volunteers will be submitted to~     quantity and quality of sleep, type of eating, fatigue and motivation level, Ashworth scale~     spasticity, cortical brain activity measures through simple pulse transcranial magnetic~     stimulation (pTMS), spinal cord activity measures through electrical stimulation and~     non-invasive brain stimulation (rTMS)~   "
3226|NCT03014986|"~     The availability of novel therapies with DAAs might prompt clinicians caring for HSCT~     recipients with HCV infection to prescribe the treatment more frequently and possibly~     earlier after HSCT. Since numerous possible therapeutic combinations exist, the choice of~     the most appropriate one is not straightforward. It depends not only on its efficacy,~     toxicity and rate of pharmacological interactions, but also on availability (both through~     healthcare system and in expanded access programs), and cost.~      This observational prospective study will focus on treatment strategies in HSCT recipients~     with HCV infection. The main focus will be the therapeutic approach, the combination of~     drugs chosen, the length of treatment and the outcome. The main reasons for treating or not~     treating HSCT recipients with HCV infection will be also explored. Compared to previous~     cohorts, this study might provide additional data in the area of non-invasive assessment of~     fibrosis, HCV-RNA levels and genotyping.~      In order to get as much data as possible on HCV treatment, patients with chronic HCV~     infection transplanted during the last 10 years will be included.~      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year~     2016 will be reported.~   "
3227|NCT03014973|"~     The main objective of the study is to determine the intra-prostatic concentration of sexual~     steroids when castration resistance appears in castration-resistant prostate cancer patients~     compared to patients naif of hormonal treatment~   "
3228|NCT03014960|"~     The purpose of the study is to investigate the effects of sleep improvement in leaders on~     leader outcomes.~   "
3229|NCT03014947|"~     This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation~     Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal~     Product (RMP) (Humira®) in healthy subjects.~   "
3231|NCT03014921|"~     This trial study and compare in blood and urinary matrices the impact of an iron injection~     on proteins involved in iron metabolism during a blood donation. The goal is to study the~     impact of an iron injection on detection markers of a blood donation in the anti-doping~     field~   "
3787|NCT03007654|"~     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an~     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.~   "
3237|NCT03014843|"~     The aim of this study was to investigate the effect of naloxone (IV or IM administration)~     and methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of~     healthy volunteers in order to evaluate the role of endogenous opiods in symptom perception~     in gastro-esophageal reflux disease. Esophageal sensitivity was assessed by using a~     multimodal esophageal stimulation protocol where sensitivity to thermal, mechanical,~     electrical and chemical stimulation was tested.~   "
3238|NCT03014830|"~     Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this~     study is that it also increases cholesterol excretion from the body into the stool, a~     process sometimes called reverse cholesterol transport. A cholesterol metabolic study will~     be done before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse~     cholesterol transport, it is possible that this action provides additional protection from~     cardiovascular disease.~   "
3239|NCT03014817|"~     The present study aims at analyzing whether ultrasonic tissue coagulation dissection~     technique offers a smoother peri- and postoperative course and reduces the risk for~     conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared~     to electrocautery in case of acute cholecystitis The study is performed as a double-blinded~     study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included~     in the study are randomized to surgery with either the traditional electrocautery based~     technique or ultrasonic scalpel based dissection.~   "
3240|NCT03014804|"~     This phase II trial studies the side effects of autologous dendritic cells pulsed with tumor~     lysate antigen vaccine and nivolumab and to see how well they work in treating patients with~     glioblastoma that has come back. Vaccines made from a person's tumor cells may help the body~     build an effective immune response to kill tumor cells. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving~     dendritic cell-autologous lung tumor vaccine and nivolumab may work better in treating~     patients with glioblastoma.~   "
3241|NCT03014791|"~     Hypertension, also known as high blood pressure, is a chronic medical condition, in which~     the blood pressure is elevated. This is a common condition, which can lead to severe~     complications such as cardiovascular disease, heart attack, stroke and kidney disease, if~     not detected and treated early.~      Accumulating evidence suggests that the incidence of hypertension varies according to age,~     ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological~     mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical~     correlates of elevated blood pressure across the adult age-span, and determine the extent to~     which body size and ethnicity impact on these associations. We also wish to investigate the~     impact of hypertension on key target organs (end-organ damage). The primary objective of~     this study is to compare the mechanisms regulating blood pressure in hypertensive and~     non-hypertensive participants across the adult age span, and to assess the influence of body~     mass index and ethnic background on these mechanisms. Secondary objectives are to~     investigate the association between blood pressure and cardiovascular physiology across the~     adult age span at rest and during sub-maximal exercise and to investigate the impact of~     blood pressure haemodynamics on key organs including the arteries and heart by assessing~     end-organ damage such as endothelial function, arterial structure and left ventricular~     mass/function.~      This study will be a combined case-control and cross-sectional study describing the~     procedures and time commitment required to investigate our scientific aims. This is a single~     centre study that will be conducted in a secondary care environment. Both male and females~     aged 18 and over and that are able provide informed consent will be considered for this~     study. People who are pregnant, currently receiving dialysis, illness with a life expectancy~     <1 year, current active malignancy and cannot provide informed consent are ineligible for~     this study. The study will be open for five years and each patient will complete a maximum~     of four visits in a 12 month period. Participants will complete a variety of non-invasive~     physiological assessments of their cardiovascular system and lung function. There will be~     some minimally invasive procedures completed, including a blood test and assessment of small~     artery endothelial function which involves insertion of a small needle under local~     anesthetic.~   "
3242|NCT03014778|"~     This study is necessary in order to provide proof the effectiveness of Chlorhexidine~     gluconate and its safety.~   "
3243|NCT03014765|"~     Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated~     dilatation capability (FMD) of the brachial artery will be measured prior to elective~     surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the~     brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds~     after cuff deflation. From above mentioned values the increase in the diameter of the artery~     during reactive hyperemia will be calculated.~      Simultaneously with the ultrasound investigations, the blood for determination of the~     endothelial dysfunction markers will be collected.~      The participants will be contacted again 3 months after the surgery and asked about the~     complications which may be associated with the surgery.~   "
3244|NCT03014752|"~     Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually~     the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs~     and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a~     low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to~     compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins~     diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients~     in each group, and will receive the diet for three months on non-randomised basis. In the~     classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each~     gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be~     established on outpatient setting, without fasting and gradually. The modified Atkins diet~     will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of~     carbohydrate plus protein.~   "
3245|NCT03014739|"~     Achilles tendon plays a significant role in walking and sporting activities, particularly~     through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line~     examination of choice for patients suspected of having Achilles tendon injury, which is more~     and more frequent. Nowadays, ultrasound elastography can be used to evaluate the~     viscoelasticity properties of Achilles tendon, however little is known about the~     reproducibility of the technique. This study aims to evaluate the reproducibility of~     supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in~     Achilles tendon and plantar fascia.~   "
3246|NCT03014726|"~     Robust I study is a feasibility study about safety and efficacy of DCB.~   "
3247|NCT03014713|"~     The purpose of this study is to explore the effectiveness of dexmedetomidine as an~     adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous~     Patient-Controlled Analgesia (PCA) after open colorectal surgery.~   "
3284|NCT03014232|"~     Hypercytokinemia contributes a major role in the pathogenesis and is associated with the~     high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled~     trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine~     removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by~     six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).~   "
3248|NCT03014700|"~     One of the most common hemostatic derangements in pediatric open- heart surgery is an acute~     acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet~     aggregation, resulting in increased bleeding and allogenic blood transfusions.~      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in~     pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen~     concentrate will be as effective in treating post-CPB bleeding and will decrease total blood~     product exposure when used as part of a blood transfusion algorithm.~      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a~     fibrinogen level <250mg/dL while on bypass.~      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard~     of care in the management of peri- operative bleeding in neonatal patients undergoing~     cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as~     effective as the standard of care, then we would plan a multi-center trial to demonstrate~     the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen~     concentrate is effective, fibrinogen concentrate could replace allogenic products and~     potentially decrease transfusion related morbidity in mortality in this population.~   "
3249|NCT03014687|"~     To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for~     pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection~     (sinusitis), and helps mucosal healing in the nasal passages.~   "
3250|NCT03014674|"~     Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb)~     that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor~     complex expressed on the eosinophil cell surface and thus inhibits signaling. This study~     will compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug~     product in two different devices with the reconstituted lyophilized drug product in healthy~     subjects. Subjects will receive a single administration of 100 milligram (mg) mepolizumab as~     a single injection. The randomization will be stratified by body weight (<70 kilogram (kg),~     70 <80 kg and >=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm,~     abdomen or thigh. Approximately 243 healthy subjects will be randomized so that at least 9~     subjects are randomized to each mepolizumab treatment within each weight strata and 3~     subjects within each mepolizumab treatment, weight strata and injection site. Each subject~     will participate in the study for up to approximately 16 weeks (up to 85 days after drug~     administration), and will have a screening visit, a single dose treatment period, and a~     follow-up visit.~   "
3251|NCT03014661|"~     Questionnaire to measure and control the quality of life of patients with hay fever who are~     treated or were treated with Pollinex quattro~   "
3252|NCT03014648|"~     This is a phase II clinical trial aimed at evaluating the efficacy of PD-L1 inhibition with~     atezolizumab in advanced squamous and non-squamous NSCLC patients previously treated with~     anti-PD-1 therapy with either nivolumab or pembrolizumab.~      In order to account for the variability of response kinetics to PD-1 directed therapy,~     patients will be enrolled in 3 parallel cohorts based on the best overall response to PD-1~     directed therapy.~        -  Cohort 1 (progressive disease)~        -  Cohort 2 (stable disease with minimum 12 weeks of therapy)~        -  Cohort 3 (partial to complete response followed by progressive disease)~   "
3253|NCT03014635|"~     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate~     to severe frown lines.~   "
3254|NCT03014622|"~     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate~     to severe frown lines.~   "
3255|NCT03014609|"~     The principal objective of the study is to measure parameters of inflammation, oxidative~     stress, and vascular, respiratory, and peripheral muscle function parameters, and identify~     parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using~     multivariate analysis.~   "
3256|NCT03014596|"~     Procedures for systematic user involvement in primary mental health services are lacking,~     and several adolescents are dissatisfied with their opportunities to influence the service~     provided. The research on the effects of user involvement is scarce, especially regarding~     user involvement for children and adolescents. Hence, we suggest introducing an idiographic~     assessment tool in a selection of Norwegian primary mental health services. Idiographic~     assessment is a way of measuring psychological constructs, by using tools specifically~     adapted for each individual respondent.~      This protocol describes the implementation and evaluation of a user involvement tool called~     'Assert', in Norwegian primary mental health services. Assert is a simple tool where the~     adolescents themselves decide the goals or themes that they would like to address in~     collaboration with their service provider. Assert is scored each time the adolescent and the~     service provider meet, to monitor progress toward the goal. A randomised controlled trial~     design is proposed for this study. Assert will be implemented in 5-10 Norwegian~     municipalities, and will include 250 participants between 12 and 23 years. The objective of~     the study is to examine the relationship between Assert and perceived user involvement. Are~     idiographic measures an adequate way to operationalise user involvement on an individual~     level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and~     mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and~     goals will be conducted to explore what matters to the adolescents that visit primary mental~     health services in Norwegian municipalities.~   "
3269|NCT03014427|"~     The storage and use of biomaterial samples is an important requirement for accompanying~     research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking~     is explicitly recommended in official guidelines. In order to preserve the biomaterial, the~     patient must consent to the removal, transfer and storage of the biomaterial separately from~     the consent to the register. The biomaterial is taken at times at which a blood or urine~     sampling takes place anyway in the clinical routine. Therefore no additional interventions~     are necessary.~   "
3270|NCT03014414|"~     People with elevated blood pressure are at higher risk of having a heart attack or stroke~     than people with lower blood pressure. Losing a modest amount of weight—such as 15 or 20~     pounds—can reduce the risk of having a heart attack or stroke. However, it can often be a~     struggle to maintain weight loss over time.~      This study examines whether two behavioral weight-management programs can help people~     maintain weight loss over time. In this study, 346 adults will be randomly assigned (like~     flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years)~     to see how their body weight may change.~   "
3257|NCT03014583|"~     Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly~     labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after~     a spine surgery. Treatment of this chronic condition by further operation or medical~     management has a heavy financial impact on health care systems.~      Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation~     (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS~     to be a clinically effective adjunct to medical management. SCS has the advantages of being~     reversible and less invasive than surgery and may cause fewer issues over time than~     long-term pharmacological treatments.~      Despite variable levels of success in the literature, approximately 30-55% of the patients~     treated with traditional SCS for neuropathic pain disorders will not receive adequate long~     term pain relief. Therefore, technical SCS system refinements, as well as new techniques~     have emerged.~      Two new stimulation waveforms based on traditional SCS technology have appeared to further~     optimize the outcome for specific painful conditions;~        -  Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500~          Hz per burst and pulse width and interspike intervals of 1 ms.~        -  High-frequency stimulation (from 1 to 10 kHz) mode.~      Several studies have demonstrated the potential interest of these 2 new waveforms to treat~     FBSS patients compared to traditional SCS.~      The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of~     waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High~     Frequency stimulation (HF)).~      To date, literature data comparing these 3 stimulation patterns is lacking but it is~     suggested the pain relief in some of non-responsive patients can be recaptured by~     increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It~     seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to~     compare the effects of these 3 different SCS modalities in FBSS patients and to determine~     which concept is the most effective in terms of pain reduction and energy consumption.~   "
3258|NCT03014570|"~     This pragmatic trial focuses on implementation of an evidence based process to increase~     person-centered management of behavioral and psychological symptoms of dementia (BPSD) in~     nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is~     known about implementation of effective interventions in nursing homes, will serve as a~     model for other programs and care approaches, and will help facilities and staff implement~     quality person-centered care, which is the goal of the National Partnership to Improve~     Dementia Care and Reduce Antipsychotic Use in Nursing Homes.~   "
3259|NCT03014557|"~     This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial~     appendage closure technology in a Chinese population.~   "
3260|NCT03014544|"~     The purpose of this study is to compare the psychometric properties (performance validity)~     of 8 individual cognitive tests in a computer-administered cognitive test battery intended~     for the assessment of cognitive function in participants with major depressive disorder~     (MDD) either in partial or full remission against 8 corresponding standard, non-reference,~     examiner‑administered cognitive tests.~   "
3261|NCT03014531|"~     The study was conducted to investigate the effects of daily almond intake based on the~     timing of almond consumption (i.e., almond consumption as a preload or between-meal snack)~     on body composition, lipid profile, and oxidative and inflammation indicators among young~     Korean adults.~   "
3262|NCT03014518|"~     Suicide is one of the most devastating events in society at all levels. The primary goal of~     this study is to predict suicide in adolescents at risk. We will utilize blood biomarker~     measurement and clinical risk factor scales to develop a tool to identify adolescents at~     risk for suicide earlier, which will allow clinicians to prescribe timely treatment and~     prevent suicide.~   "
3263|NCT03014505|"~     Imbalance of gut bacteria is suspected to play a key role driving the progression of~     cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study~     will determine if fecal microbiota transplantation is an effective and safe treatment for~     decompensated cirrhosis.~   "
3264|NCT03014492|"~     The purpose of the study is to monitor longitudinal changes in brain structure and function~     between the preseason and postseason, in a population of soccer playing athletes wearing the~     Device and compared to a similar population not wearing the device. Secondly, the purpose is~     to determine the protection of the device relative to amount and magnitude of sustained head~     impacts.~   "
3265|NCT03014479|"~     The purpose of this study is to assess the reduction in treatment burden during 12 weeks of~     trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy~     only.~   "
3266|NCT03014466|"~     Preoperative anxiety in pediatric patients undergoing surgical procedures has been~     previously shown to increase the likelihood of family stressors, post- operative pain,~     agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is~     to use a non-invasive device to determine whether a bed mounted Video Projection unit (i.e.~     BERT, Bedside EnterRtainment Theater) is more effective than the standard of care tablet~     (i.e., iPad) for preventing anxiety before surgery among children undergoing anesthesia and~     surgery. The anticipated primary outcome will be reduction of child's anxiety in the~     preoperative and operating room setting and compliance with mask induction.~   "
3267|NCT03014453|"~     Bronchopulmonary dysplasia(BPD) is a common condition in the low birth weight~     infants.Although most of the BPD symptoms improved after a regular treatment in infancy,~     there are still a few late complications left such as the frequent respiratory symptoms, a~     slower weight gain and even sudden death. These late complications have made so much trouble~     to the healthcare of BPD infants.How to find the risk factors and to reduce the prevalence~     of these late symptoms becomes necessary. It has been reported that gastroesophageal~     reflux(GER)is a long-lasting form in the extremely premature infants with~     BPD,however,whether it serves as a potential risk for the late complications is still~     unclear.In this study, a cohort of BPD infants was observed with the late complications~     obtained by a monthly followed up for 12 months after discharge, the prevalence and risk~     factors were analyzed by Cox's proportional hazards regression model.As one of the risk~     factors, GER was verified whether to play a critical role in these late complications.~   "
3268|NCT03014440|"~     The purpose of this study is to determine if cannabidiol is safe and effective at different~     doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has~     potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure~     frequency. There are only a few open label studies that have demonstrated the safety and~     tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies~     were performed either retrospectively or with varying cannabidiol preparations. There are no~     well-documented studies and completely analyzed data for pediatric epileptic patients.~   "
3297|NCT03014063|"~     This is a prospective observational cohort trial evaluating a single plasma vasopressin~     concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The~     trial is designed to determine whether plasma vasopressin concentration influences the~     likelihood of hemodynamic response to exogenous vasopressin therapy.~   "
3271|NCT03014401|"~     The purpose of this study is to compare the clinical and functional outcomes of patients~     with mild to moderate arthroscopically confirmed osteoarthritis between the following two~     groups:~        1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with~          standard arthroscopic treatment consisting of: partial meniscectomy, cartilage~          stabilization, loose body removal and selective synovectomy.~        2. Standard arthroscopic treatment (above) with out cell transplant.~   "
3272|NCT03014388|"~     Using growth factors obtained from patient's venous blood mixed with particulate autogenous~     bone the study compares bone gain by implant with gold standards in sinus Lift procedures~     for future implant insertion.~   "
3273|NCT03014375|"~     The purpose of this study is to:~      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and~     faeces~   "
3274|NCT03014362|"~     The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation~     (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a~     treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with~     fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and~     medication therapies. There will be 6 months of follow-up, in order to establish the ongoing~     and lasting therapeutic effect of TMS.~   "
3275|NCT03014349|"~     The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann~     applanation apparatus and pneumatic in the water drinking test.~   "
3276|NCT03014336|"~     The drawbacks of chemical CO2 absorbers include the production of compounds harmful to~     patients that also lead into increased cost and environmental impact, as well as the daily~     disposal of compound special waste. Sustainable management of general anesthesia is a~     growing concern. Continually diluting anesthetic circuits, and the disposal of chemical~     granulate are serious environmental problems.~   "
3277|NCT03014323|"~     Investigators will test the hypothesis that chronic restoration of vagal nerve activity with~     a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose~     tissue oxidation in obese African American Women compared to white women.~   "
3278|NCT03014310|"~     This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the~     safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8~     virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with~     or without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150~     (up to 380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good~     health and meet all eligibility criteria. The entire study duration is approximately 24~     months and each subject participation duration is approximately 13 months. The primary~     objectives are: 1) To assess the safety and reactogenicity of a monovalent inactivated~     influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly~     at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59~     adjuvants approximately 21 days apart. 2) To assess the serum HAI and Neut antibody~     responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of~     two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose)~     given with or without AS03 or MF59 adjuvants approximately 21 days apart.~   "
3279|NCT03014297|"~     This is a single center, open label, phase I study involving grade I-III~     gastroenteropancreatic neuroendocrine tumors, consisting of a dose escalation Part A~     followed by an expansion cohort Part B. On Part A Patients will be treated with daily oral~     everolimus. Fosbretabulin will be administered IV either q3 weekly or q weekly based on PO~     CRM cohort. Part B: Once the investigators have established an MTD in Part A, the~     investigators will be treating 15 more patients at that dose combination. The primary and~     secondary objectives of the expansion cohort will be similar to Part A of the study, i.e.,~     to establish a safety profile of the experimental drug combination and to collect and assess~     efficacy data. Patients will be treated with concurrent everolimus and fosbretabulin for 12~     weeks.~   "
3280|NCT03014284|"~     This is a simple tissue collection study with no therapeutic intent. Colon tissues will be~     taken from standard of care procedures. Tissues will be tested for their functions,~     expression of immune co-signaling molecules and reactions to transduction with recombinant~     Listeria vectors to assess effects on expression of B7-H1 and cytokines.~   "
3281|NCT03014271|"~     Sources of Strength is an evidence based program for youth suicide that trains student key~     leaders to strengthen social connectedness and healthy norms school-wide and is listed on~     the National Registry of Evidence Based Programs and Practices (NREPP). This project will~     expand the existing evidence base by evaluating Sources of Strength for sexual violence~     outcomes in a randomized controlled trial (RCT) in twenty-four high schools.~   "
3282|NCT03014258|"~     This is a phase I study that will assess the acquisition of immunity to Pf malaria over the~     course of 4 sequential Controlled Human Malaria Infections (CHMI) over 3 years, in 10~     healthy adult participants. The study is expected to last for 48 months and will include 28~     healthy male and female volunteers (10 study volunteers and 18 naïve controls to confirm Pf~     infectivity during the 2nd -4th CHMI challenges) ages18 to 45 years, inclusive, from the~     greater Baltimore community.~      The primary objective of this study is to determine whether protective immunity against~     parasite infection develops following repeat CHMI.~   "
3283|NCT03014245|"~     Melatonin is well known for its role in the sleep-wake cycle but it is less well known as an~     effective antioxidant. It has been reported to be synthesised in the placenta and may have~     both receptor mediated and non-receptor mediated protective functions during pregnancy.~     Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the~     placenta although it is not known if the placental melatonin contributes to circulating~     levels. There is little reported on the circulating levels of melatonin or oxidative stress~     at different stages of normal pregnancy. More information on the role of melatonin and~     metabolism of melatonin in pregnancy as well as any significant association with adverse~     pregnancy outcomes would inform planning of larger research studies to investigate the~     potential role for melatonin as a biomarker for obstetric disease and potentially as a~     therapeutic agent in future.~      This observational pilot study aims to measure serum melatonin levels and 6-hydroxymelatonin~     sulphate (the major metabolite of melatonin) during each trimester of pregnancy.~   "
16000|NCT02847910|"~     The purpose of this study is to explore the clinical effect of disposable tissue suction~     tube set for induced abortion and make comparison with traditional metal instruments．~   "
3285|NCT03014219|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell~     transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single~     dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas~     will be enrolled.~      Subjects will undergo standard adjuvant therapy including drainage of infection and~     placement of a draining seton. Six weeks post placement of the draining seton, the seton~     will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The~     subjects will be subsequently followed for fistula response and closure for 24 months. This~     is an autologous product derived from the patient and used only for the same patient.~   "
3286|NCT03014206|"~     This study aims to understand the following items in post-marketing actual clinical settings~     to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged~     65 years or older).~        1. To confirm the use in actual clinical settings~        2. To confirm the occurrence of adverse events~   "
3287|NCT03014193|"~     This study evaluates the usability of the multilevel pregnancy test among women undergoing~     medical abortion.~   "
3288|NCT03014180|"~     The purpose of the LEVEA study is to assess the performances of a new automatic left~     ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by~     physicians during in-hospital follow-up.~   "
3289|NCT03014167|"~     Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH~     guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to~     targeted populations, including pre-school age children and school-age children. However~     mathematical models suggests that current MDA strategies are not sufficient for interrupting~     disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have~     successfully treated entire populations with albendazole (in combination with ivermectin or~     diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project~     will conduct a series of community-based cluster randomized trials in India, Malawi, and~     Benin to determine if maintaining three years of MDA with albendazole to entire communities~     following the cessation of LF programs can interrupt STH transmission in focal geographic~     areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus~     targeted MDA of children in interrupting the transmission of STH. Nested implementation~     science research will be used to optimize the intervention, identify contextual factors~     influencing trial efficacy, and evaluate the feasibility of sustaining and scaling~     community-wide MDA for STH. These data will provide evidence necessary to inform future~     guidelines, policies, and operational plans as country partners engage in intensified~     approaches to eliminate these disabling diseases.~   "
3290|NCT03014154|"~     Asthma is a chronic inflammatory disease of the Airways of recurring character. The~     obstruction to the airflow carries the short-and long-term consequences that require~     prophylactic interventions and in emergency many times. The children due to immaturity of~     the respiratory system associated with the use of steroids suffer structural consequences,~     as for example, the physical deconditioning that intensifies the symptoms of the disease and~     affects negatively on the quality of life. Therefore, to set up a physical training program~     suitable for the paediatric population, using resources to increase adherence to the regular~     practice of exercises, can be the difference for the reduction of the number of~     exacerbations, the sensation of Dyspnea and the doses of medication, positively impacting~     the clinical picture of child asthmatic. The investigators conducted a randomized, blinded~     in order to evaluate the effects of training with active video game associated with resisted~     exercise the exercise in inflammatory and functional outcomes resisted in asthmatic~     children.~   "
3291|NCT03014141|"~     The consumption of oat bran fiber also has a significant bulking effect in humans. However,~     besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the~     purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan)~     supplementation on bowel function and appetite.~   "
3292|NCT03014128|"~     Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related~     to many occupational situations and specific industries. However, there is conflicting~     information about monotonous and repetitive activities. In this context, the profession of~     surgical device mechanics has not been analyzed so far.~      The objective of this study is to examine surgical device mechanics at different workplaces~     with varying work contents and to compare them with a control group without the repetitive~     workload exposition as described above. The headquarters and main production site of~     Aesculap are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of~     surgical devices.~      After statistical power analysis, the investigators plan to randomize and include a total of~     90 voluntary test persons in 3 groups (30 persons each). The study will include standardized~     questionnaires and a physical examination as well as an industry test (Purdue Pegboard~     Test).~      Primary and secondary endpoints were defined to show if significant difference between~     surgical device mechanics and a control group is present.~   "
3293|NCT03014115|"~     The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA~     in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented~     for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection~     rates, immune markers) and safety information in these 12-18 month old infants.~   "
3294|NCT03014102|"~     The purpose of this study is to determine whether recombinant human thrombopoietin are~     effective in peripheral blood progenitor cells mobilization for autologous transplantation.~   "
3295|NCT03014089|"~     The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in~     healthy adult subjects.~   "
3296|NCT03014076|"~     The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2~     peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment~     of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a~     primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of~     the study are the following:~        -  Assess safety and document local and systemic toxicity to combination immunotherapy~          with GP2 peptide + GM-CSF vaccine and trastuzumab~        -  Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of~          GP2 peptide + GM-CSF vaccine and trastuzumab~        -  Determine maximum tolerated dose and optimal biologic dose for the combination~          immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab~   "
3298|NCT03014050|"~     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction,~     cognitive impairment, and other non-motor symptoms. Here, we propose to use Bio Electro~     Stimulation Therapy (B.E.S.T.) using the e-Tapper TT-R1owned by Immumax International Co.~     Ltd., a Hong Kong based company. The e-Tapper is a non-invasive, handheld electronic~     device designed to apply micro current stimulation to a person's hand at specified points~     representing various body parts, such as the head, leg, or foot. This is one form of Bio~     Electro Stimulation Therapy, known as 11-point Hand Treatment System. The current~     delivered is less than one milliampere. Anecdotal evidence suggests that this micro current~     stimulation may reduce resting tremor, restore facial expressions, and improve ease of~     movement, mood, and sleep quality in patients with PD. Scientific evidence for the~     effectiveness of the B.E.S.T. Hand Therapy appears to be lacking in the English language~     (Western) literature. The goal of this pilot study is to examine whether B.E.S.T. can~     increase physical activity and functional fitness, enhance cognition, improve mood and~     subjective sleep quality, and modulate resting tremor and gait parameters in PD patients~     over a 6-week period.~   "
3299|NCT03014037|"~     Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects~     nearly 27 million people in the United States. This disease leads to the breakdown of the~     cartilage surfaces of the joints, which serve as the connection points between the bones of~     the body, causing a large amount of pain and disability in patients. Increasing the number~     of available treatment options for osteoarthritis is becoming increasingly more important as~     Americans continue to age. Using stem cells taken from bone marrow is one of the~     non-operative treatments that has been gaining popularity in the recent past. This study~     aims to clarify how this procedure should best be done by comparing stem cell concentrations~     and patient outcomes (short and long term) in patients who have stem cells taken from one~     area vs two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).~   "
3300|NCT03014024|"~     Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks.~     After removing the cast, it is common to still have pain, swelling and reduced mobility in~     the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.~   "
3301|NCT03014011|"~     Hypoglycaemia in subjects suffering from type 2 diabetes may have substantial consequences~     including a significant negative impact on quality of life. Further, repeated minor~     hypoglycaemias may result in significant productivity losses.~      Here, the investigators propose to provide quantitative results on cognition during an acute~     mild hypoglycaemic episode (target plasma glucose 3 mmol/L) in 28 subjects with type 2~     diabetes. Data will be provided on executive function, attention and memory.~   "
3302|NCT03013998|"~     This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic~     screening followed by assigning and accruing simultaneously to a multi-study Master~     Protocol (BMAL-16-001-M1). The specific subtype of acute myeloid leukemia will determine~     which sub-study, within this protocol, a participant will be assigned to evaluate~     investigational therapies or combinations with the ultimate goal of advancing new targeted~     therapies for approval. The study also includes a marker negative sub-study which will~     include all screened patients not eligible for any of the biomarker-driven sub-studies.~   "
3303|NCT03013985|"~     The purpose of this study is to find out if treatment with Glargine U300 when compared to~     Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),~     who are admitted to the hospital and then transition at home, after discharge from the~     hospital.~   "
3304|NCT03013972|"~     Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients~     die from colorectal cancer each year. The third leading cause of death is colorectal cancer~     in Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy~     and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.~     However, disease and treatment-related toxicities in cancer patients may result in fatigue~     and interfered quality of life (QoL). Previous studies have reported that cancer-related~     fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases,~     it can occur during treatment, in advanced disease and in disease-free survivors; the~     prevalence of fatigue is reported to be between 59-96% in patients undergoing chemotherapy,~     65-100% in patients receiving radiation therapy, and 30% in long term survivors. Also, CRF~     has been reported as the most frequent and distressing toxicity of colon and rectal~     chemotherapy. The National Comprehensive Cancer Network (NCCN) has published guidelines for~     the definition of CRF as ''a persistent subjective sense of physical, emotional, and/or~     cognitive tiredness or exhaustion related to cancer or cancer treatment that is not~     proportional to recent activity and that significantly interferes with usual functioning.~     Besides, CRF could dynamically change with the interactions among disease progression,~     treatment regimen, tumor site, nutrition, infection or other factors. Therefore, to minimize~     the impact of CRF on cancer patients, more in-depth researches on CRF are needed.~      The aim of this longitudinal study is to examine the dynamic changes, correlated factors and~     QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the~     results will supply physicians with more understanding about CRF, and help them to enhance~     the quality on cancer care to being perfected in the future.~   "
3305|NCT03013959|"~     As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex~     virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In~     Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical~     application of NSAIDs. To explore more effective clinical treatment of viral keratitis~     patients to control the inflammatory damage, save the visual function and reduce the~     recurrence of the virus ,we observe the effect of anti-inflammatory and inhibition of~     recurrence on the herpes simplex virus after topical NSAIDs administration.~   "
3306|NCT03013946|"~     The primary objective of the trial is to determine the effect of a 24-week concomitant~     coaching on patient reported outcomes of patients receiving standard treatment for mRCC with~     sunitinib.~   "
3307|NCT03013933|"~     This phase I trial studies the side effects and best dose of brentuximab vedotin and~     cyclosporine when given together with verapamil in treating patients with Hodgkin lymphoma~     that has come back or does not respond to treatment. Monoclonal antibodies, such as~     brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread.~     Immunosuppressive therapies, such as cyclosporine, may improve bone marrow function and~     increase blood cell counts. Verapamil may increase the effectiveness of brentuximab vedotin~     by overcoming drug resistance of the cancer cells. Giving brentuximab vedotin, cyclosporine,~     and verapamil may work better in treating patients with Hodgkin lymphoma.~   "
3319|NCT03013777|"~     To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and~     depression in adult patients with familial dysautonomia. Patients will be enrolled in an~     8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia~     Center or over the phone to help accommodate disability and potential physical limitations~     of our patient population.~   "
3308|NCT03013920|"~     Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary~     tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion~     and to collect tissue for histopathology. These techniques are considered to be the gold~     standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in~     combination with endo-urological procedures, seems promising to improve diagnosis of~     urothelial cancer. CLE image characteristics for UTUC still have to be defined.~      Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess~     in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial~     carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively~     comparing CLE images with both histopathology from diagnostic biopsies and pathology from~     the therapeutic radical nephroureterectomy. Secondary objectives are the development of an~     imaging atlas and to assess the technical feasibility and procedure related adverse events~     of CLE.~   "
3309|NCT03013907|"~     The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and~     efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase~     Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension.~     UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1~     hour/week by phone.~      Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual~     interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this~     study is a randomized controlled trial (RCT) that will compare the effects of the adapted~     UPLIFT program to usual care (UC) and to test mediators and moderators of the effects of~     UPLIFT.~   "
3310|NCT03013894|"~     Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up~     of primary and recurrent bladder cancer have some limitations. CLE, a high resolution~     imaging technique, that can be used combined with endo-urological procedures, seems~     promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic~     applied confocal laser endomicroscopy (CLE) still has to be defined.~      Objective: To directly correlate CLE images with histopathology, and identify and define CLE~     characteristics of normal urothelium, benign bladder urothelium, and bladder tumors~     (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.~      Primary objective: to develop descriptive image interpretation criteria and a classification~     of CLE images of bladder tissue through a review of prospectively obtained CLE videos from~     bladder tissue correlated with histopathology.~      Secondary objectives:~        -  Assessing procedure related adverse events of CLE~        -  Assessing technical feasibility of CLE~        -  To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign,~          low-grade or high-grade and CIS)~   "
3311|NCT03013881|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     escalating single-dose of UB-921 in healthy male volunteers.~   "
3312|NCT03013868|"~     Despite the growing public awareness and recent progress in multimodality therapy to the~     colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly~     cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant~     metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated~     with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to~     prevent the development of metastasis. Early detection and characterization of CTCs is~     therefore important as a potential strategy to monitor the progression of CRC. The current~     proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R~     system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.~   "
3313|NCT03013855|"~     This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for~     the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in~     pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for~     spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition,~     some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE.~     This study aims to assess the correlation between FIT using the stool sample from DRE~     (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the~     investigators may be able to demonstrate efficacy of FIT using a DRE in the clinic setting.~     This may help avoid logistical barriers, as well as improve compliance and adherence to~     colon cancer screening in the outpatient setting, eventually leading to improved quality of~     care.~   "
3314|NCT03013842|"~     Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human~     subjects, in order to obtain fetal heart rate.~      We want to determine if this device can accurately measure a baby's oxygen level when placed~     on your abdomen.~      Current technology to measure a baby's oxygen levels requires a probe to be inserted into~     the vagina.~   "
3315|NCT03013829|"~     The purpose of this study is to evaluate the effectiveness of a targeted educational~     approach designed to increase knowledge about the risks and benefits of living donation~     generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce~     KPD concerns, and facilitate informed decision making about KPD among incompatible or~     cross-match positive donor-recipient pairs.~   "
3316|NCT03013816|"~     The objective of this study is to evaluate the effectiveness of targeted video interventions~     designed to increase organ donation knowledge, intentions, and designations among~     adolescents enrolled in driver's education classes, as well as to increase the commitment of~     parents/legal guardians to authorize organ donation in the event of their adolescent's~     death. The central hypothesis is that integrating donation education into the driver's~     education curriculum will increase knowledge and attitudes that facilitate the behavioral~     action of donor designation at the time of getting a new driver's license.~   "
3317|NCT03013803|"~     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study~     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to~     show that it is acceptable for patients in the United Kingdom.~   "
3318|NCT03013790|"~     We are studying the use of Melatonin in non-ventilated patients over the age of 65. Primary~     endpoint will be assesments of delirium, with secondary endpoints to include length of stay,~     use of anti-psychotic medications, and mortality~   "
3329|NCT03013647|"~     Twenty patients with multiple actinic keratosis on the face will be enrolled in the study~     and will be treated with Daylight Photodynamic therapy.~      Before and after skin biopsies will be performed, for histological and immunohistochemical~     analysis.~   "
3320|NCT03013764|"~     Physical inactivity results in reductions in glucose tolerance and less sensitivity to~     insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2~     diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2~     diabetes. Thus the investigators are interested in establishing if during a period of~     inactivity if a diet modification can minimize the glucose changes normally observed with~     inactivity. The objective of this project is to determine if short-term high protein (HP)~     feeding protects against the changes in glucose levels normally observed with physical~     inactivity. The investigators will also examine measures of blood vessel function, blood~     lipid and blood pressure.~      Twelve subjects will complete two 10 day study periods of reduced physical activity and will~     be studied before and after each of these study periods. For their testing subjects will~     have the following measurements: postprandial glucose responses to a mixed meal, 24 h free~     living blood pressure control during acute physical inactivity, blood lipids, changes in~     body composition, changes in circadian rhythm using skin temperature (ibutton), measurement~     of aerobic capacity (VO2 max), blood vessel responsiveness (flow mediated dilation -FMD) and~     changes in free living glucose levels (continuous glucose monitoring system (CGMS). Subjects~     will complete two conditions (high protein -HP vs normal protein - NP diets) in a randomized~     cross-over design. In the inactive phase subjects will reduce there steps to &lt;5,000~     steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10~     weeks.~   "
3321|NCT03013751|"~     This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III~     clinical trial to provide safety information regarding the long-term use of udenafil in~     adolescents with single ventricle congenital heart disease.~   "
3322|NCT03013738|"~     This randomized controlled trial aimed to assess the efficacy of a 40-session~     cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive~     schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia~     (secondary outcomes). The GPS's impact on behavioral change (e.g., in the reduction of~     disciplinary incidents and prison records) was also tested, in order to ascertain if changes~     observed in cognitive and emotional variables were reflected in a more adjusted behavioral~     pattern. Personality Disorders were also tested as moderators of treatment effects.~   "
3323|NCT03013725|"~     The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in~     1997-99 (HUSK). Both surveys were conducted as a joint project between the University of~     Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of~     Public Health) and the Municipal Health Service in Hordaland.~      The main focus of the studies is on chronic diseases including cardiovascular disease,~     cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,~     occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug~     use. The main purpose of the surveys is to gather information so that disease ultimately can~     be prevented.~      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000~     in 1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93~     survey also participated in 1997-99.~   "
3324|NCT03013712|"~     The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T~     Cells infusion for EpCAM positive Cancer.~   "
3325|NCT03013699|"~     This study will examine the effects of a dietary intervention in post-treatment head and~     neck cancer survivors on the ability to function physically, tiredness, and quality of life,~     as well as on changing markers in the blood that are associated with better recurrence and~     survival.~   "
3326|NCT03013686|"~     The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic~     appendectomy with follow-up MRI in patients with initially successfully treated~     periappendicular abscess.~      Periappendicular abscess is generally initially treated conservatively with antibiotic~     therapy and if necessary, drainage. Operative treatment in the acute abscess phase is~     associated with increased morbidity and thus complicated appendicitis with a~     periappendicular abscess is initially treated conservatively. However, there is debate on~     whether interval appendectomy is required.~      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular~     abscess, patients enrolled in the PeriAPPAC study are randomised either to interval~     appendectomy or to follow-up with MRI at two months after the initial treatment. All~     patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients~     after the MRI (outpatient visit at endoscopy unit with information on the MRI).~      The primary endpoint is the treatment success in both treatment arms. In the interval~     appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up~     treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year~     follow-up.~      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku~     University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio~     University Hospital and Jyvaskyla Central Hospital.~   "
3327|NCT03013673|"~     In this cohort study, the investigators will study the asymptomatic period preceding the~     onset of active Visceral Leishmaniasis (VL) in HIV‐infected individuals from VL endemic~     regions in Ethiopia as an avenue to develop an evidence‐based screen and treat strategy to~     prevent progression to active VL.~   "
3328|NCT03013660|"~     Preterm birth is the leading contributor to mortality among children younger than 5 years.~     One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the~     mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few~     hours, ideally every day. This intervention can make breastfeeding easier and can improve~     the health and development of the baby.~      Unfortunately, despite the large health benefits, mothers in low-resource communities are~     often unable to practice STSC due to a range of institutional and economic barriers. STSC~     requires substantial time and financial commitments from mothers; they must travel from home~     each day to the hospital to engage in STSC and provide expressed breast milk. Low-income~     women with access only to limited federally provided unpaid family leave may have to choose~     between returning to work while their baby is in the NICU and being able to stay at home~     with their newborn after discharge from the NICU. Families of preterm infants also face~     direct financial costs of practicing STSC and breastfeeding (such as fees for parking and~     childcare for older children).~      This trial aims to examine the impact of providing additional support to low-income mothers~     of babies born preterm in a hospital in Boston, Massachusetts to help them provide STSC.~     Half of the participants will be randomized to receive an additional financial support~     intervention while their infant is in the NICU. The study will examine how this intervention~     impacts mothers' health behavior while their child is in the NICU and up to three months~     after.~      Most of the current and past policy efforts to increase STSC have focused on the delivery of~     STSC at hospitals, focusing on supply-side related challenges such as the lack of trained~     and informed staff. However, interventions that focus exclusively on hospitals are unlikely~     to be sufficient for low-income women if there are significant opportunity costs or~     transportation costs to simply being present at the hospital. This study aims to provide~     more evidence to determine whether removing these financial barriers has the potential to~     mitigate the poor outcomes of preterm babies born to lower socioeconomic status households.~   "
3331|NCT03013621|"~     Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery,~     and is a major risk factor for mortality in this context.~      The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common~     complication, close to 100% if one takes into account the transient dysfunction.~      A recent study showed that right ventricular dysfunction and the IRA seemed related, rather~     on the slope of venous congestion. We wish to study this phenomenon more specifically in~     particular to offer reliable diagnostic markers of venous congestion.~   "
3332|NCT03013608|"~     Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries.~     The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The~     empirical reparation technique is the nail bed suture and the relocation of the nail plate.~     However, some authors think that suture the nail bed could increase the traumatism of the~     nail bed because of the needle, the crush by the clamps and by the stitches too tight~     (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to~     treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the~     nail bed. Advantages of this technique, claimed by the author, was time saving, with an~     aesthetical result as same as the treatment with suture of the nail bed. A same study~     validated the technique in a paediatric population (Langlois et al., 2010). So, it seems~     that it is not necessary to suture the nail bed. But, in our practice, the investigators~     noted complications not mentioned in previous studies: hematomas causing pain, effusion and~     dislocation of the nail plate, with constrain the patient to consult in emergency. The~     2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our~     hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric~     population is enough to have good to excellent aesthetical results, with less complications~     and a lower cost, than the other techniques. The aim of this study is to assess the~     aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries~     in children.~   "
3333|NCT03013595|"~     This study evaluates the longitudinal health and social outcomes of adolescent mental health~     service users who are at the transition boundary of their child and adolescent mental health~     service, and whether the implementation of a model of managed transition at the service~     boundary benefits them, as compared to usual care.~   "
3334|NCT03013582|"~     Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand~     therapists alike. Despite their commonality, no consensus exists as to the best means of~     preventing adhesions, or the most ideal methods to treat them once they have occurred. The~     purpose of this study is to compare patient outcomes after standard operative tenolysis~     performed for adhesions of the hand to outcomes after tenolysis with the use of allograft~     human amniotic membrane.~   "
3335|NCT03013569|"~     This is a pilot feasibility study for a new application of an approved fetal heart rate~     monitoring device system. The objective of this study is to validate the feasibility of~     acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the~     routinely used scalp fetal heart rate (FHR) monitor.~   "
3336|NCT03013556|"~     The current study is a prospective, randomized, open, multi-center investigation. The aim of~     the study is to investigate whether the HBeAg seroconversion rate can be improved if~     applying combination therapy in HBeAg positive CHB patients who has achieved~     HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.~   "
3337|NCT03013543|"~     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight,~     hunger assessments and other factors in patients with rare genetic disorders of obesity,~     including POMC deficiency, LepR deficiency, Bardet-Biedl syndrome and Alström syndrome.~   "
3338|NCT03013530|"~     A new law about the advance directives (AD) has been recently voted in France on February 2,~     2016. This  Claeys-Leonetti  law has made the AD more binding, as in other countries. This~     should lead to a greater respect of the human autonomy principle. However, the~     interpretation of these guidelines is often difficult and may differ between doctors.~     Indeed, the subjectivity of these interpretations could lead to different medical decisions~     by physicians.~      The investigators intend to assess the effect of advance directives (AD) on decision making~     in care by intensivists, using a simulated (hypothetical) situation.~   "
3339|NCT03013517|"~     This is an open-label, follow-up study for subjects who completed the PEPITES study.~     Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg~     for 2 additional years if previously on active treatment in the PEPITES study, or for 3~     years if previously on placebo in the PEPITES study.~   "
3340|NCT03013504|"~     The purpose of the study is to determine whether HD201 is effective in the treatment of~     HER2+ metastatic breast cancer.~   "
3341|NCT03013491|"~     The purpose of this first-in-human study of CX-072 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072~     administered intravenously (IV) as a single agent or in combination with ipilimumab or~     vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.~     PROCLAIM-001: PRObody CLinical Assessment In Man CX-072 clinical trial 001~      CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).~     Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the~     therapeutic index by minimizing drug interaction with normal tissue while retaining~     anti-tumor activity. Probody therapeutics are masked to attenuate binding to target in~     healthy tissue but can become unmasked in the tumor microenvironment by tumor-specific~     protease activity.~      PROBODY is a trademark of CytomX Therapeutics, Inc.~   "
3342|NCT03013478|"~     To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding~     CBT4CBT to treatment as usual in a community based primary care program in a population of~     60 individuals who meet current DSM criteria for substance use disorder other than nicotine.~   "
3343|NCT03013465|"~     The objectives of the study are 1) to determine the influence of daily consumption of~     well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine~     inflammatory marker changes consistent with decreased cancer risk.~   "
3344|NCT03013452|"~     In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI),~     50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.~   "
3345|NCT03013439|"~     The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.~   "
3346|NCT03013426|"~     This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely~     ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as~     to determine the maximum tolerated dose (MTD) in this population. The information gained~     from this study will be used in making decisions about the appropriate dose(s) and dosing~     schedule in future multicenter studies of the efficacy of NVX-508 in the treatment of~     vaso-occlusive episodes (VOE).~   "
3347|NCT03013413|"~     This clinical trial studies an ultrasound-based imaging procedure called elastography using~     the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound~     is a non-invasive imaging technique that uses high-frequency sound waves to produce images~     of internal structures. Elastography uses ultrasound imaging techniques to examine the~     stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is~     not yet known whether elastography imaging using the Aixplorer system works better than~     standard ultrasound imaging in detecting prostate cancer.~   "
3348|NCT03013400|"~     This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus~     placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder.~     Half of the participants will receive ebselen and the other half placebo. The trial, will~     last a total of four weeks.~   "
3349|NCT03013387|"~     This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients~     with somatostatin receptor positive tumors.~   "
3350|NCT03013374|"~     The adequacy of the quality of protein supply could influence the rate and the relative~     composition of weight gain in very low birth weight preterm infants.~      Aim of the study is to investigate protein balance according to feeding regimen and the~     association between human milk feeding and fat free mass content at term corrected age in a~     cohort of very low birth weight infants.~   "
3351|NCT03013361|"~     Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or~     infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)~     block, infraorbital nerve block and nasociliary block. As the current evidences regarding~     the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion~     block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult~     patients undergoing FESS under general anaesthesia in this study.~   "
3352|NCT03013348|"~     A retrospective validation study of a post-processing method intended to identify~     psychogenic nonepileptic seizures~   "
3353|NCT03013335|"~     The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade~     3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC~     who have progressed during or after receiving at least one prior systemic anti-angiogenic~     treatment and who are eligible for nivolumab monotherapy.~   "
3354|NCT03013322|"~     Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to~     assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20~     patients with perioperative sepsis and septic shock as a result of intra-abdominal infection~     are enrolled. According to randomization, participants are treated with physostigmine~     salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean~     Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive~     care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome~     measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics~     study investigates plasma concentrations of physostigmine and its metabolite eseroline.~     Further analyses will contribute to the understanding of the role of various cytokines in~     the pathophysiology of human sepsis. A computer-generated list is used for blocked~     randomization.~   "
3355|NCT03013309|"~     This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health~     (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients~     will be recruited based on their BMI as documented in the EHR and randomized to receive the~     FCU4Health or Treatment as Usual.~   "
3356|NCT03013296|"~     Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.~   "
3357|NCT03013283|"~     Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway~     Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are~     delivered to the patient via an interface.~      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the~     device. Because the comfort and degree of satisfaction of the patients to its interface is a~     key factor of the observance, side-effects and satisfaction of patients need to be~     continuously evaluated with available interfaces for CPAP and NIV treated patients.~      The purpose of the research is the evaluation of interface side-effects and the degree of~     satisfaction of home care patients treated for at least three months with CPAP or NIV.~   "
3358|NCT03013270|"~     This study investigates the effects of aerobic, resistance, inspiratory training modalities~     outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming~     for the 'optimum' (greek, αριστος=aristos) training program for HF patients.~   "
3359|NCT03013257|"~     Graves' disease (GD) is an autoimmune thyroid disorder caused by stimulating auto-antibodies~     to the thyrotrophin (TSH) receptor on thyroid follicular cells. It is the most common cause~     of hyperthyroidism and approximately 3% of women and 0.5% of men develop GD in their~     lifetime.~      RAI has been shown to be a cost-effective and safe therapy in patients with GD but with some~     disadvantages. In addition, despite its proven efficacy and safety, many patients do not~     wish to undergo RAI because of radiation fear and prefer to either continue ATDs or have~     surgery.~      High-intensity focused ultrasound (HIFU) is a non-invasive procedure that involves the~     application of a high-energy focused beam for thermal tissue ablation within a targeted~     zone. Similar to the principle of RAI (i.e. using ionizing radiation to ablate thyroid~     parenchyma and cause GD remission), we postulated that the heat energy generated from HIFU~     could also be used to ablate the thyroid parenchyma and cause GD remission. The idea of~     using heat energy to ablate thyroid parenchyma minimally invasively was recently reported~     using radiofrequency ablation but to our knowledge, we are one of the first (if not the~     first) group to propose using HIFU energy to ablate thyroid parenchyma as a definitive~     treatment for relapsed GD.~      Having obtained ethical approval, a pilot study was conducted to examine the efficacy and~     safety of HIFU as a treatment for relapsed GD. In the pilot study, all patients underwent a~     safe and successful HIFU ablation for relapsed GD. Based on the results of the pilot study,~     we hypothesize that a single HIFU treatment to the thyroid gland may be as effective as our~     standard outpatient fixed-dose of RAI (370MBq) in causing remission of GD at 6-month. If our~     hypothesis turns out to be true, HIFU could become a treatment option for patients who are~     indicated for RAI but do not wish to have it because of one reason or another. HIFU appears~     to induce a faster disease remission and lessen the need of deferring pregnancy and~     radiation precautions because of the absence of radioactivity.~   "
3360|NCT03013244|"~     The purpose of the present study was to investigate the acceptability and efficacy of a~     cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle~     dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized~     that the program would reduce eating disorder risk factors to a greater degree compared to~     wait list control and that these effects would be maintained at 1 month follow-up.~   "
3361|NCT03013231|"~     Despite the large majority of patients that undergo ACL reconstruction reporting successful~     outcomes in regard to tests of knee function, only about 2/3 return to their prior level or~     athletic activity after surgery. A large amount of research has been conducted investigating~     the effects of psychological factors on return to sports after ACL reconstruction; however,~     the specific role of resilience has yet to be solely analyzed. This study aims to determine~     the effect of variations in patient resilience on their return to sports after surgery.~   "
3362|NCT03013218|"~     A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and~     lymphoma~   "
3363|NCT03013205|"~     Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with~     the frozen shoulder. In this study, investigators will compare intra-articular steroid~     injections with direct coracohumeral ligament steroid injection to conventional~     intra-articular steroid injection. Investigators will measure the primary outcome as~     shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of~     coracohumeral ligament under elastogram.~   "
3364|NCT03013192|"~     Patients who are prescribed physical therapy exercises for their shoulder will have~     increased compliance to their PT exercises, an increased PROMIS- Upper Extremity CAT score,~     and will have increased range of motion (or reach maximum range of motion earlier) at the~     end of the 3 month EpxPhysicalTherapy intervention.~   "
3365|NCT03013179|"~     Our project, the Intergenerational Blood Pressure Study, is a 5 year research study funded~     by the National Institutes of Health/National Institute of Nursing Research and led by the~     Yale University School of Nursing and The Consultation Center at the Yale University School~     of Medicine, Department of Psychiatry in partnership with Head Start programs across CT. We~     seek to reduce hypertension health disparities among underserved Black/African American~     children and their mothers by conducting community-based research to better understand the~     genetic, psychological, and environmental factors that may contribute to high blood~     pressure.~   "
3366|NCT03013166|"~     To describe clinical outcomes and both primary and secondary care health care resource use~     in patients who have been prescribed either immediate-release (IR) hydrocortisone or~     modified-release (MR) hydrocortisone or prednisolone in the UK.~   "
3367|NCT03013153|"~     Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still~     argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing~     the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis,~     and total mesorectum excision. However, debate on the level of IMA ligation and debonding of~     splenic flexure never ends. This study is going to give a clear and definite answer to how~     and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D~     reconstruction of IMA and identification of IMA perfusion types.~   "
3368|NCT03013140|"~     Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in~     caesarean section can effectively reduce the incidence of hypotension and fetal~     complications.~   "
3369|NCT03013127|"~     This is a phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475)~     in patients with osteosarcoma who have experienced disease relapse or progression after at~     least one line of systemic treatment, and who are not eligible for curative surgery.~   "
3370|NCT03013114|"~     Primary immune thrombocytopenia (ITP) is a disorder caused by autoantibody-mediated platelet~     destruction and decreased platelet production. It has been reported that refractory ITP is~     closely related to long-lived plasma cells (PCs), which are resistant to glucocorticoids,~     conventional immunosuppressive and cytotoxic drugs, irradiation and B-cell depletion~     therapies.~      Proteasome inhibition bortezomib is one of the most promising therapeutic approaches to~     target PCs, since this strategy has been shown to efficiently eliminate multiple myeloma~     cells, that is, transformed PCs. It also has been successfully used in SLE-like mice,~     experimental autoimmune MG rats and experimental hemophilia-A mice that develop anti-factor~     VIII antibodies in preclinical models by depleting both short-lived and long-lived PCs.~     Additionally, treatment with bortezomib resulted in a rapid clinical response in a patient~     with refractory thrombotic thrombocytopenic purpura associated with the depletion of~     inhibitory autoantibodies against ADAMTS13, a metalloproteinase that cleaves the von~     Wille-brand factor, which is produced by plasma cells. Hence, the elimination of~     autoreactive PCs by proteasome inhibitors might represent a new treatment strategy for~     autoantibody-mediated diseases.~      To date, refractory ITP is lacking of effective treatments and these findings encouraged us~     to conduct a study of bortezomib in management of ITP with high anti-platelet antibodies~     level. Data from this study may provide some idea of bortezomib in the treatment of ITP.~   "
3371|NCT03013101|"~     This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1~     antibody JS001, as a monotherapy in patients with locally advanced or metastatic melanoma~     who have failed in routine systemic treatment.~   "
3372|NCT03013088|"~     This is a clinical study aimed at demonstrating the safety and product performance of the~     SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System~     can facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO)~     located in the lower extremity arteries without major adverse events related to SoundBite~     device utilization.~   "
3373|NCT03013075|"~     The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation~     of stress response, decrease in pulmonary vascular resistance, myocardial protection and~     positive myocardial oxygen balance will cause improvement in right ventricular function. So~     far there is no study that has evaluated the effect of HSA anesthesia on the right~     ventricular function, hence the investigator planned this study to compare the effect of HSA~     on the right ventricular function in patients with mitral valve disease with severe~     pulmonary hypertension planned for mitral valve replacement surgery.~   "
5006|NCT02991716|"~     Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected~     subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using~     existing, approved ECG recording devices.~   "
3375|NCT03013049|"~     Vitiligo is a complex disease causing a selective, often progressive, loss of functioning~     melanocytes from epidermal basal layer resulting in white patches on the skin and~     occasionally mucosae. Worldwide prevalence of vitiligo is around 1% whereas in India it is~     around 3-4% ranging from 0.46% to 8.8%.~      Etiopathogenesis of vitiligo is multifactorial consisting of genetic, immunological and~     environmental factors. Environmental and genetic factors act in concert to destroy~     melanocytes. Reactive oxygen species (ROS) play important roles in vitiligo pathology,but~     the autoimmune pathogenesis has been proposed as one of the main causes of vitiligo.~      Surgical methods, mainly transplantation of non cultured epidermal cell suspension are~     effective treatment for stable vitiligo. Transplantation of autologous noncultured epidermal~     cell suspension and non-cultured dermal cell suspension in combination (a mode of cellular~     grafting technique) is a novel surgical method for the treatment of vitiligo. Cytotoxic CD8+~     ( cluster of differentiation 8+) cells in vitiligo perilesions may dictate the fate of~     transplantation, and strategies against CD8+ T cell activation might be beneficial for~     patients undergoing melanocyte transplantation. Mesenchymal cells could inhibit T cell~     proliferation and induce T cell apoptosis. Bartsch first identified and characterized dermal~     mesenchymal cells (DMCs). They have a multi-lineage differentiation potential into~     adipocytes, osteocytes and chondrocytes.Vitiligo patients' autologous melanocytes~     transplantation efficiency may be predicted by perilesional skin-homing CD8+ T cell~     activities, and the immunoregulatory DMCs might be used as auxiliary agent to improve the~     efficacy.~      This pilot study is planned to compare transplantation of autologous noncultured epidermal~     cell suspension v/s its combination with non-cultured dermal cell suspension as a novel~     method in vitiligo surgery in stability of vitiligo with regards to extent of~     repigmentation, color matching of repigmented area, patient satisfaction and adverse events~     if any. This is the first study using transplantation of autologous noncultured epidermal~     cell suspension and non-cultured dermal cell suspension in combination as a new modality in~     vitiligo surgery.~   "
3376|NCT03013036|"~     Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement~     of thyrohyoid distance for difficult intubation and determination of optimal endotracheal~     tube size by using USG in pediatric patients undergoing elective surgery.~   "
3377|NCT03013023|"~     This randomized controlled trial will use a longitudinal repeated-measures design to examine~     the effects of two interventions, behavioral support interventions and a parent-infant~     transactional program, on parents' stress, PPD and sleep quality, parent-infant~     interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns,~     emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years~     corrected age.~   "
3378|NCT03013010|"~     Although the incidence of gastric cancer has been substantially declining for several~     decades, it is still the sixth most common cancer and the fourth most frequent cause of~     cancer death worldwide. Surgery is still the only curative option for gastric cancer.~     However, most patients are unable to undergo surgery because of late stage, unresectable~     disease. The prognosis for these patients is very poor. Although the Magic trial showed that~     perioperative chemotherapy can increase the rate of curative surgery and significantly~     improve overall survival in patients with operable gastric or lower esophageal~     adenocarcinomas, no pCR events were reported in this trial. The intervention arm in PREACT~     consists of pre-operative chemotherapy, pre-operative radiochemotherapy, surgery and~     post-operative chemotherapy. The control arm consists of pre-operative chemotherapy,~     surgery, and post-operative chemotherapy. The primary purpose of PREACT is to investigate~     whether the addition of radiochemotherapy to chemotherapy is superior to chemotherapy alone~     in the pre-operative setting in improving disease free survival in patients with locally~     advanced gastric or esophagogastric junction adenocarcinoma.~   "
3379|NCT03012997|"~     Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be~     ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II~     will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to~     the arterial blood gas sample results) during surgery and in Postoperative care unit.~      Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate~     ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and~     post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.~   "
3380|NCT03012984|"~     Delirium is a frequently occurred cerebral complication in elderly patients after surgery,~     and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be~     one of the most important risk factors of postoperative delirium. Previous studies showed~     that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine~     infusion improved the quality of sleep and decreased the incidence of delirium. The~     investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine~     supplemented analgesia can also decrease the incidence of delirium, possibly by improving~     sleep quality. The purpose of this multicenter, randomized controlled trial is to~     investigate the impact of dexmedetomidine supplemented analgesia on the incidence of~     delirium in elderly patients after cancer surgery.~   "
3381|NCT03012971|"~     A majority of the elderly patients undergo surgery for malignant tumors. For these patients,~     postoperative tumor recurrence and metastasis are main factors that worsen long-term~     outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in~     elderly patients after cancer surgery may help to maintain immune function and improve~     long-term outcomes, possibly by relieving stress and inflammatory response, improving~     analgesic efficacy and sleep quality, and reducing delirium incidence.~   "
3382|NCT03012958|"~     The purpose of this study is to learn more about new noninvasive ways of detecting lung~     disease in US Military personnel and people who worked as contractors during military~     operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing~     test called the lung clearance index (LCI) test which is being investigated as a potential~     noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers~     retuning from Iraq and Afghanistan.~   "
3383|NCT03012945|"~     Surgical resection is one of the most important treatments for malignant tumor; on the other~     hand, tumor recurrence and/or metastasis are the major reasons of treatment failure. The~     outcome after surgery mostly depends on the balance between the immunity of human body and~     the capability of implantation, proliferation and neovascularization of the tumor.~     Preclinical and retrospective studies suggest that anaesthetic techniques and drugs may~     affect the long-term prognosis in patients undergoing cancer surgery. The investigators~     hypothesize that epidural anesthesia-analgesia may improve the long-term outcome of the~     elderly patients who are scheduled to undergo major thoracic and abdominal surgery for the~     treatment of malignant tumor.~   "
3384|NCT03012932|"~     The proposed study will examine the implementation of a Human Papilloma Virus (HPV)~     self-sampling intervention for under screened LBQ women living in South Florida. The study~     will enroll participants to receive the self-sampling intervention in community venues. The~     purpose of this study is to pilot the self-sampler for feasibility and acceptability within~     this underserved population.~   "
20630|NCT02787161|"~     This is a randomized controlled clinical trial that will analyze the impact of high volume~     online HDF in comparison to high-flux HD on measured physical activity.~   "
3385|NCT03012919|"~     Rivers et al. laid the foundation for modern hemodynamic and fluid management by~     establishing goal directed therapy (GDT) for the treatment of sepsis using fluid and~     inotropic and vasoactive agents. There have been many subsequent protocols to improve~     outcome in the operating room or in the ICU. These are mainly passive decision support~     systems. Active clinical decision support systems using fluid and pharmacologic agents to~     improve intraoperative hemodynamics are not really found.~      The investigators developed an active clinical decision support system based on an~     institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid~     device.~      The goal of the study was to check the feasibility of an active clinical decision support~     system to optimize hemodynamics during high risk vascular surgery based on the principles of~     GDT implementing fluid, vasopressors and inotropes.~   "
3386|NCT03012906|"~     Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and~     requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are~     required to receive triple antithrombotic therapy . This triple therapy includes dual~     antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant~     with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).~      Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the~     coagulation cascade have demonstrated non inferiority compared to VKA to prevent~     thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 .~     Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.~     Overall they seem to result in a lower bleeding rate compared to VKA in association with~     antiplatelet agents.~      Recently European guidelines regarding patients requiring chronic anticoagulant therapy and~     undergoing coronary stent implantation have been updated. However they are based on an~     expert consensus because of the scarce data available.~      These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and~     aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5~     . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and~     thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines~     suggest that a sole antiplatelet agent could be used in addition to anticoagulation~     following the WOEST study . In the recently published ESC guidelines on the management of~     atrial fibrillation, despite the lack of new data, the expert advocate triple therapy~     followed by dual antiplatelet therapy in most patients for 12 months.~      The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in~     these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban~     15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically~     relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar~     efficacy .~   "
3387|NCT03012893|"~     To determine the accuracy of two techniques (transverse scan and sagittal scan) using~     ultrasonography to identify C7 spinous process compare to the fluoroscope (standard~     technique)~   "
3388|NCT03012880|"~     This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and~     daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib~     citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     daratumumab, may block cancer growth in different ways by targeting certain cells. Giving~     ixazomib citrate, lenalidomide, dexamethasone, and daratumumab may work better in treating~     patients with newly diagnosed multiple myeloma.~   "
3389|NCT03012867|"~     Different enteral nutrition formulas are tested on their effect on glucose homeostasis in~     critically ill medical patients.~   "
3390|NCT03012854|"~     This study compares the clinical efficacy of safety of circular myotomy and full-thickness~     myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in~     achalasia patients.~   "
3391|NCT03012841|"~     To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX®~     Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic~     persistent atrial fibrillation.~   "
3392|NCT03012828|"~     This study will investigate the effect of a single oral dose of moxidectin on the QT~     interval associated with moxidectin plasma concentrations.~      The effect of moxidectin on other ECG intervals, and on safety, will also be assessed, as~     will preliminary pharmacokinetics and metabolism~   "
3393|NCT03012815|"~     The current gold-standard for the management of alcohol withdrawal syndrome (AWS) is~     symptom-triggered administration of benzodiazepines. This method of treatment has several~     drawbacks that have been described in the literature. Thus benzodiazepine sparing agents~     have been evaluated for use in AWS. One of these agents that has not only shown benefit for~     AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and~     cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this~     purpose. Due to the limited reports of the safety and efficacy of a protocol involving~     gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be~     completed.~   "
3394|NCT03012802|"~     Short title POWER Audit~      Methods 60 days national (Spain) audit of postoperative complications following elective~     gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.~      Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To~     provide detailed data describing post-operative complications and associated mortality; and~     length of stay.~      To provide detailed data describing adherence to ERAS protocol and its association to~     morbidity.~      Number of patients Not specified. All eligible patients undergoing surgery during the study~     month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower~     gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.~      Statistical analysis Univariate analysis will be used to test factors (patient, surgical,~     and ERAS related) associated with surgical complications, length of stay (LOS) and~     in-hospital death. Single and multi-level logistic regression models will be constructed to~     identify factors independently associated with these outcomes and to adjust for differences~     in confounding factors. A stepwise approach will be used to enter new terms. A single final~     analysis is planned at the end of the study.~      Summary statistics with post hoc Bonferroni corrections will be used to assess possible~     dose-response dependence in percentage of patients with postoperative complications and LOS.~      Proposed Start Date A 60 day period between 2017~      Proposed End Date~      Data collection will end by September 2017~      Study Duration Six months~   "
3395|NCT03012789|"~     The purpose of this study is to evaluate the effect of different surgical resections (R0,~     R1, R2) on circulating NET transcripts (PCR score or NETest). A drop in circulating NET~     levels will be correlated with surgical excision. Secondly, variation of circulating NET~     transcripts will be correlated to NET recurrence to test whether this analysis may~     constitute an early predictive marker of disease relapse.~   "
3840|NCT03006952|"~     This study was designed to assess the efficacy of adding pentoxifylline to losartan in~     comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.~     also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and~     C-reactive protein~   "
3396|NCT03012776|"~     The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS~     System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to~     stabilize a single lumbar level (L2 - L5) following surgical decompression in patients~     diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1~     spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or~     scarring of the facet joint capsule.~      Success will be assessed by means of a composite endpoint that measures improvement in in~     patient reported outcomes and the absence of any major device related complications.~   "
3397|NCT03012763|"~     The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine,~     given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral~     administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml~     grapefruit juice prior to ingestion and to visualize the localization and to measure the~     filling volume of stomach, small intestine as well as ascending, transverse and descending~     colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water~     (non-caloric water), after administration of 240 ml caloric drink and after administration~     of 240 ml grapefruit juice.~   "
3398|NCT03012750|"~     Microcirculation should be assessed before and after tibial bypass surgery by intraoperative~     fluorescence angiography. According to this, the direct and the indirect angiosomes should~     be compared according to the individual microcirculatory improvement.~   "
3399|NCT03012737|"~     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea~     in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and~     from oncology ward. The main outcomes are the compliance of the subjects with the treatment~     and alleviation of dyspnea during the treatment period.~   "
3400|NCT03012724|"~     The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS,~     (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the~     FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously~     unsuccessfully treated with antidepressant medications.~   "
3401|NCT03012711|"~     This study is an evaluation of the effects of a Neuromuscular training program on hip~     strength and core stability. It is a randomized clinical trial evaluating pre and post~     scores.~   "
3402|NCT03012698|"~     The current study aims to test the safety of Repeated Magnetic Stimulation (RMS) treatment~     for dry eye. Patients will be asked to undergo a one-time treatment with Epitech Corneal~     Magnetic Stimulation Device on one eye. Changes will be monitor for over a study period of 3~     months.~   "
3403|NCT03012685|"~     Most people will experience a psychologically traumatic event, such as a life-threatening~     accident, at some point in their life. In the initial days after such an event, it is common~     to be haunted by intrusive memories: image-based memories of the event that spring to mind~     unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark~     symptom of post-traumatic stress disorder (PTSD).~      Sleep is important for many functions involved in how people perceive, respond to and~     remember events, including stressful/traumatic events. Studies with patients who have~     experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma~     are associated with later PTSD symptoms. However, in a previous study with healthy~     volunteers exposed to experimental trauma (film footage), those who were sleep-deprived in~     the first night, compared to those who slept, had fewer intrusive memories in the following~     week. This raises the question of how sleep in the first night, but also the first week,~     after real-life trauma is related to subsequent intrusive memories and PTSD symptoms.~      The current study is an observational study of patients recruited from a hospital emergency~     department after a traumatic event. After completing brief baseline questionnaires in the~     emergency department, participants will be asked to fill in a daily diary of their sleep and~     intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and~     depression will be assessed by post/online at one week and two months. Participants will be~     telephoned after two months to complete an interview to assess PTSD symptoms and an optional~     feedback interview.~      This clinical study will be the first to assess the relationship between sleep in the first~     night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings~     may have implications for developing simple sleep-based preventive treatments after trauma~     in the future.~   "
3404|NCT03012672|"~     This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine,~     and mitoxantrone work in treating medically less fit patients with newly diagnosed acute~     myeloid leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine,~     cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether giving cladribine, cytarabine, and mitoxantrone at~     higher or lower dose may work better in treating patients with newly diagnosed acute myeloid~     leukemia.~   "
3405|NCT03012659|"~     The purpose of this study is to assess the impact of a provider counseling training on~     patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10~     Planned Parenthood health centers.~   "
3406|NCT03012646|"~     This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled~     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with~     Chronic Obstructive Pulmonary Disease (COPD).~   "
3407|NCT03012633|"~     During liver transplantation (LT), hyperfibrinolysis is one of the most important~     modification of haemostasis. It is associated with t-PA and protein C increased activity.~     Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The~     diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA,~     PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the~     clinical practice in the operating room.~      The Lysis Timer is a device developed by Hyphen-Sysmex in collaboration with SD Innovation~     and Charleroi University Hospital (Belgium). It allows the implementation of the Global~     Fibrinolytic Capacity, or GFC test, in a complete system associating i) the reagents for in~     vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and~     calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal~     of the absorbance modifications related to clot formation into a numeric signal) and iii) a~     dedicated software treating the numeric signal to define clot lysis time.~      The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the~     diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.~   "
3408|NCT03012620|"~     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the~     efficacy and safety of pembrolizumab monotherapy in 6 cohorts of patients with specific rare~     cancers who have unresectable locally advanced or metastatic disease, which is resistant or~     refractory to standard therapy, or for which standard therapy does not exist, or is not~     considered appropriate, and for which no other experimental treatment options are available,~     in order to identify subsets of patients that may benefit from treatment~   "
3409|NCT03012607|"~     Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical~     to the success of HIV treatment and therapeutic prevention. No accurate, objective~     point-of-care test is available to monitor adherence to either ART or PrEP. The inability to~     accurately identify poorly adherent patients will lead to more HIV infections (from failed~     PrEP and non-suppressive ART), more drug-resistant virus (selected by failing ART), and~     unnecessary switching to costly second- or third-line ART (when first-line regimens with~     virologic efficacy but non-adherence are stopped inappropriately). To address this critical~     knowledge gap, the investigators have developed a novel point-of-care test to detect the~     presence of tenofovir—the most common drug in both ART and PrEP treatments worldwide—in~     fingerprick blood or urine as an objective measure of ART and PrEP adherence.~      Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will~     support point-of-care tenofovir detection as an objective measure of adherence, and that our~     point-of-care tenofovir assay will have the ability to discriminate different drug adherence~     levels. The investigators will test our central hypotheses by pursuing the following two~     specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood~     and urine specimens within a controlled pharmacokinetic study of HIV-negative adults~     receiving tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and~     (2) To validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens~     using an existing biorepository from a real-world clinical HIV prevention study.~      This work is innovative because it develops an entirely new category of rapid diagnostic~     testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay~     will help clinicians identify patients in need of more adherence counseling, which when~     implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary~     ART regimen switching—measures that will improve national HIV programs and help preserve the~     global supply of an effective HIV medication.~   "
3410|NCT03012594|"~     This is a human research study looking at the effectiveness of Lanreotide (study medication)~     in treating small bowel motility disorders. It is similar to a natural hormone somatostatin~     that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a~     growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting~     medication that is given once a month. It is marketed with a trade name Somatuline Depot.~     It is given deep subcutaneously (deep within the layers of the skin) in the superior~     external quadrant of the buttock. Injection site will be alternated on subsequent~     injections.~   "
3411|NCT03012581|"~     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the~     efficacy and safety of nivolumab monotherapy in 5 cohorts of patients with specific rare~     cancers who have unresectable locally advanced or metastatic disease, which is resistant or~     refractory to standard therapy, or for which standard therapy does not exist, or is not~     considered appropriate, and for which no other experimental treatment options are available.~   "
3412|NCT03012568|"~     This is a clinical investigational plan (CIP) for the Clinical Study to Confirm MRI Safety~     and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI). This study~     intends to enroll patients who meet standard bradycardia or tachycardia indications and have~     already been implanted with one of the SJM device/lead combinations listed in this protocol.~     The objective of this study is to confirm the safety and effectiveness of each of the four~     SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored~     by St. Jude Medical.~   "
3413|NCT03012555|"~     There are approximately 90,000 individuals in the United States with sickle cell disease~     (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a~     vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to~     20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic~     inflammation and related pain. This study will be coordinated with patients' regularly~     scheduled visits for medical care and will require patients to submit blood sample at the~     start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for~     a bone density measurement (DXA scan) at the start of the study and after 12 months of~     supplementation to assess for any bone re-mineralization. Thus, the main purpose of this~     study is to find the amount of nutritional vitamin D that needs to be taken by patients with~     sickle cell disease in order to correct vitamin D deficiency. The study will also test~     whether vitamin D supplements improve bone health and reduce inflammation.~   "
3414|NCT03012542|"~     Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom~     control and disease remission. Historically certain diets have been recommended for patients~     with Crohn's disease during exacerbations despite lack of data supporting efficacy. The~     investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to~     moderately active Crohn's disease to one of two diets that differ in the amount and type of~     carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated~     for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the~     microbiome.~   "
3415|NCT03012529|"~     The purpose of this research study is to determine if rifampin, an antibiotic (a medicine~     that treats infections), is effective in treating osteomyelitis (infection of the bone) of~     the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long~     period of time, many diabetic patients remain at a high risk for needing an amputation of~     part of the foot or lower leg because the osteomyelitis is not cured. Some small research~     studies have shown that addition of rifampin to other antibiotics is effective in treating~     osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with~     osteomyelitis have been studied, there is no definite proof that it is better than the usual~     treatments for diabetic patients. If this study finds that adding rifampin to the usual~     antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be~     able to more effectively treat many Veteran patients with this serious infection. Improving~     treatment outcomes is an important healthcare goal of the VA.~   "
3416|NCT03012516|"~     The aim of this study is to evaluate a one year intervention with physical activity on~     prescription (PAP) treatment for patients in a primary health care center setting versus an~     enhanced PAP-support with physiotherapist regarding physical activity (PA) level, metabolic~     health effects and health-related quality of life.~      One hundred ninety patients, 27-85 years, physically inactive, having at least one component~     of the metabolic syndrome and not responding with increased PA level after a 6-months~     PAP-treatment in primary health care centre are randomized to either enhanced support by~     physiotherapist (Intervention group) or continued ordinary PAP-treatment at the health care~     centre (Control group).~   "
3431|NCT03012321|"~     This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men~     with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have~     ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a~     1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes~     including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2,~     GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent~     olaparib.~   "
3417|NCT03012503|"~     Background: Neck pain effects a significant number of individuals and is commonly treated~     with chiropractic cervical manipulation. The temporary increases in neck pain following~     cervical manipulation may contribute to a lack of compliance with prescribed therapy that~     following this therapy which in turn commonly contributes to protracted symptoms. Topical~     menthol has previously been shown to decrease pain shortly following application. The~     purpose of this study was to determine if patients with mechanical neck pain who received~     topical menthol gel applied to their neck prior to cervical manipulation would have less~     pain and increased neck range of motion following cervical manipulation than patients who~     did not receive menthol.~      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were~     randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before~     cervical manipulation, controls received a placebo gel applied to their neck while the~     treatment group received a menthol containing gel (Biofreeze®) applied to their neck.~     Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at~     one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical~     manipulation. Six measures of neck range of motion were assessed prior to topical~     applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare~     pain ratings and neck range of motion following manipulation while controlling for Pre~     measures.~   "
3418|NCT03012490|"~     The primary objective is to determine whether comprehensive remote follow-up in HF patients~     with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure~     hospitalizations, whichever comes first, when compared to basic remote monitoring, over a~     27-month follow-up.~   "
3419|NCT03012477|"~     This research study is studying a combination of drugs as a possible treatment for~     triple-negative breast cancer that has spread to other areas of the body. The names of the~     study interventions involved in this study are:~        -  Cisplatin~        -  AZD1775~   "
3420|NCT03012464|"~     Patients aging less than 45 years with rectal prolapse will undergo full pathologic and~     functional assessment to determine the underlying etiology.~   "
3421|NCT03012451|"~     The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an~     innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living~     in urban settlements in Jordan. The study was conducted using two waves of data collection:~     the first featured an intervention and a matched control group, the second featured a full~     randomized control trial.~   "
3422|NCT03012438|"~     During surgery in which the thyroid is removed (thyroidectomy), the identification of~     parathyroid glands, that should be saved, can be challenging. Therefore, there is need for~     accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands~     can be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).~      Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid~     surgery will provide real-time intraoperative visualization of the parathyroid glands.~      This prospective observational feasibility study aims to evaluate the feasibility of the use~     of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18~     years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing~     total thyroidectomy are suitable for inclusion. In all patients, undergoing total~     thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of~     7.5 mg ICG, will be tested on feasibility and imaging characteristics.~   "
3423|NCT03012425|"~     The other aim of this study is to determine which of those two treatments (acupuncture or~     cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of~     cancer patients.~   "
3424|NCT03012412|"~     The current study aims to test the efficacy a mindfulness based intervention for women~     facing fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI~     comprises 10 weekly group sessions of approximately 2 hours each, run in small groups of~     10-15 women. The main goal of MBPI intervention is to reduce depressive and anxiety symptoms~     and promote infertility self-efficacy and acceptance and mindfulness skills. The MBPI is~     intended to develop willingness/acceptance through a process of contacting the present~     moment and be in touch with the unfolding experience in an open and non-judgmental way,~     particularly infertility-related experiences.~   "
3425|NCT03012399|"~     The goal of this clinical research study is to learn if it is possible to perform a~     relaxation method called hypnosedation before and during breast cancer surgery in order to~     avoid the need for general anesthesia. The safety of this procedure will also be studied.~   "
3426|NCT03012386|"~     This proposal will test the hypothesis that chronic treatment with sildenafil with and~     without the use of nitric oxide substrate, L-arginine, protects against fatty acid induced~     impairment of endothelial function, improves insulin-stimulated microvascular recruitment,~     insulin sensitivity and glucose uptake in CD36 rs3211938 G-allele carriers.~   "
3427|NCT03012373|"~     This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of~     efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy~     both combined with methadone treatment services for heroin addicts.~   "
3428|NCT03012360|"~     Antimicrobial treatment could be beneficial in patients with ventilator-associated~     tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT~     (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of~     transition from VAT to ventilator-associated pneumonia (VAP).~   "
3429|NCT03012347|"~     To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use~     testing, in a controlled indoor environment~   "
3430|NCT03012334|"~     This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square~     design with 5-period (full) crossover study with subjects randomized to treatment sequences.~     Subjects will complete all 5 Periods.~      During each Period, subjects will come to the clinical research unit (CRU) and remain~     overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo~     in the morning. Cognitive testing and driving simulation will be conducted post dosing.~     Subjects will have a washout of at least 5 days between each Period.~      This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with~     an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect~     treatment effects.~   "
20746|NCT02785640|"~     This dual-arm randomised study aims to test a multi-component intervention to reduce~     sedentary behaviour in a cohort of desk-based office workers.~   "
3432|NCT03012308|"~     The ultrasound evaluation of left ventricular filling pressures (LVRP) is well validated in~     a population of cardiac patients and medical resuscitation (...) This evaluation has a major~     interest in the management, notably haemodynamic but also respiratory, of resuscitation~     patients.~      No studies have evaluated the relevance of these markers in the postoperative context of~     cardiac surgery.~      Left atrium pressure (POG) directly reflects LVRPs and is measured in surgical resuscitation~     by a surgically placed catheter as part of routine institutional care and will serve as~     gold-standard.~      In order to study the clinical repercussions of these estimated ultrasound POG and PRVG~     values, we will study their correlation with clinical signs and ultrasound of OAP.~   "
3433|NCT03012295|"~     Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most~     important causes of hypertension. Generally, patients occur hypertension in early age, have~     family history, and often manifest severe hypertension or refractory hypertension. At~     present, only a few hypertension centers of hospitals in China will help clinically~     difficult diagnosis hypertensive patients to test some selective genes, while most of other~     hospitals still perform diagnosis based on biochemical examination and clinical symptoms.~     Therefore, in order to provide better guidance for the diagnosis and treatment for~     hypertensive patients, this project aims to develop a single gene detection panel for~     genetic hypertension, so as to provide new diagnostic technology for early intervention,~     prevention and treatment of hypertension in clinics.~   "
3434|NCT03012282|"~     This pilot clinical trial studies how well computed tomography (CT) perfusion images work in~     assessing treatment response in patients with pancreatic cancer. Analyzing specific~     measurements on the CT perfusion images may help doctors better determine how a tumor~     responds to chemotherapy and/or radiation therapy and may help guide treatment for patients~     with pancreatic cancer.~   "
3435|NCT03012269|"~     This study aims to conduct a contrast study on the characteristics of functional and~     structural connectivity of neural networks of working memory in patients with acquired brain~     injury versus normal controls, using resting-state functional connectivity magnetic~     resonance imaging, task-specific functional magnetic resonance imaging and diffusion tensor~     imaging, combined with cognitive behavioral examinations. Another purpose is to reveal the~     characteristics of dynamic change of neural networks of working memory pre- and~     post-intervention in patients with working memory dysfunction.~   "
3436|NCT03012256|"~     Rationale:~      In Canada, home care clients are a large and expanding subgroup of medically complex older~     adults with relatively poor access to effective chronic disease management. They have double~     the emergency department utilization rate compared to nursing home residents or other older~     populations. The investigators previously published a case-finding tool (the Detection of~     Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been~     recommended for chronic disease management case-finding in home care. The investigators~     recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of~     supportive cardio-respiratory disease management.~      Objectives:~      The investigators will evaluate a cardio-respiratory disease management model in home care~     to manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic~     cluster-randomized trial will be conducted by a collaboration of trial investigators and~     public home care providers (i.e., health regions).~      The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a~     targeted, person-centered cardio-respiratory management model.~      The main question is:~      P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted~     using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex,~     cardio-respiratory management model, C: compared to regular care, O: reduce~     cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits,~     reduce unplanned hospital use, improve patient activation, or improve health-related quality~     of life for clients, T: over a 6-month follow-up period from baseline?~   "
3437|NCT03012243|"~     In order to compare percutaneous cholecystostomy and leaving a drain in situ with~     percutaneous gallbladder aspiration we plan to undertake a double-blind randomized~     controlled trial.~   "
3438|NCT03012230|"~     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when~     given together with pembrolizumab in treating patients with stage IV triple negative breast~     cancer that has spread to other places in the body. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib~     phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating~     patients with stage IV triple negative breast cancer.~   "
3439|NCT03012217|"~     This is a performance study to test the sensitivity and specificity of the BioFire FilmArray~     Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test~     residual NPS specimens and generate performance data to support regulatory classification of~     the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada,~     and other regions.~   "
3440|NCT03012204|"~     To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb~     motor dysfunction due to cerebral vascular disease.~   "
3441|NCT03012191|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited~     skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7),~     the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal~     adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators~     recently demonstrated in 5 such patients that intradermal and topical gentamicin induced~     read-through of their nonsense mutations and created robust and sustained new C7 and AFs~     at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and~     reduced new blister formation. No untoward side effects occurred. Herein, the investigators~     propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In~     theory, this intravenous administration has the possibility of treating simultaneously all~     of the patients' skin wounds. The investigators also propose optimizing the concentration~     and manner of delivery of topical gentamicin. The unambiguous milestones will be increased~     C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of~     significant gentamicin side effects.~   "
16151|NCT02845908|"~     The aim of this study was to compare the efficacy and safety of FOLFOX, POF and FOLFOX plus~     paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.~   "
3442|NCT03012178|"~     Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the~     severity of mitral regurgitation is central to determining which patients are appropriate~     for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe~     MR is made, patients are considered appropriate for mitral valve surgery in almost all~     clinical circumstances. However, there is a significant mortality and morbidity associated~     with mitral valve surgery The most common diagnostic tool to assess the severity of MR is~     echocardiography. Several studies have shown that echocardiography parameters used to~     quantify and qualify MR have high inter-observer and intra-observer variability, calling the~     accuracy of these parameters into question. Furthermore, studies have shown that there is a~     significant degree of discordance between echocardiography and MRI when assessing MR,~     particularly among patients referred for mitral valve surgery. In a recent study,~     quantification of mitral regurgitant volume MRI was found to be more accurate than~     echocardiography in patients who underwent mitral valve surgery. All 38 patients who~     underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA~     guidelines based on echocardiographic findings. However, more than 2/3rds of patients who~     underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose~     this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients~     undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life~     and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post~     surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.~     repair according to MR severity by MRI.~   "
3443|NCT03012165|"~     A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the~     Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of~     ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute~     Allergic Conjunctivitis.~   "
3444|NCT03012152|"~     This non randomized study is a comparative study between standard conservative breast~     surgery and oncoplastic surgery as regard margin status and patient satisfaction.~   "
3445|NCT03012139|"~     This study is designed to gain a better understanding of the mechanisms leading to muscle~     wasting and metabolic abnormalities in skeletal muscle of cancer patients.~   "
3446|NCT03012126|"~     This project seeks to build on innovative strategies to optimize the care of low-income~     children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement~     a new clinical-community intervention, theoretically grounded in the Integrated Clinical and~     Community Systems of Care Model, to address obesity through optimized screening and~     management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's~     Healthy Weight and Your Child weight management program (originally known as MEND). The~     study will examine outcomes for children that matter most to a broad group of stakeholders~     including parents, clinicians, and public health practitioners as well as inform the care of~     >7 million children with obesity covered by the Children's Health Insurance Program or~     Medicaid.~   "
3447|NCT03012113|"~     Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian~     individuals (representing 20% of the world population) have an increased risk of obesity and~     related disorders. They are at higher risk for the development of T2D as compared to white~     Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms~     that might explain these ethnical differences have not been clarified or understood yet. As~     a consequence, treatment options are limited and unfocussed, and novel specific strategies~     are needed.~      Brown adipose tissue (BAT) has recently been discovered as a major player in energy~     metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and~     glucose from the circulation and subsequently combusts FA and glucose into heat, thereby~     increasing energy expenditure and improving glucose and FA metabolism. Using~     18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT~     scan analysis investigators have recently shown that South Asian individuals have less brown~     adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy~     metabolism, which could underlie their increased predisposition for obesity and the~     development of T2D.~      Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic~     effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis,~     glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore~     activation of BAT is considered as a novel therapeutic target in the treatment of obesity~     and T2D. As cold exposure is not the most desired therapeutic strategy for humans, current~     pre-clinical research focuses on pharmacological activation of BAT.~      β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies~     using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor~     agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even~     attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist~     (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as~     cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to~     activate BAT and enhance energy expenditure, especially for South Asians.~      Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However~     this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI,~     which has no radiation burden, has emerged as a novel method to visualize BAT in humans.~     Activation of BAT results in combustion of intracellular lipid stores, which eventually~     leads to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using~     MRI technology the activation of BAT can be quantified by the relative reduction in the TG~     content of BAT. The use of MRI to visualize and quantify BAT activity is a safe,~     cost-effective and innovative alternative to PET-CT, which has a potential to become a new~     gold standard in the nearby future.~      To investigate whether β3-receptor agonism has therapeutic potential to improve the~     metabolic phenotype of South Asians, investigators will perform a randomized cross-over~     study in which 20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2)~     are included. Dutch South Asian individuals (n=10) and matched Dutch white Caucasian~     individuals (n=10) will participate in a cross-over study consisting of three different~     regimes.~      This study will investigate whether β3-receptor agonism has therapeutic potential to improve~     the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT~     activity in South Asians have never been studied before. Elucidating the effects of this~     β3-receptor agonist on BAT activity in South Asians might have major clinical implications,~     as it might result in the discovery of a potential novel treatment strategy to combat~     obesity and T2D in this especially vulnerable population.~   "
3448|NCT03012100|"~     This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide~     vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative~     breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may~     help the body build an effective immune response to kill tumor cells. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and~     cyclophosphamide may work better in treating patients with triple negative breast cancer.~   "
3449|NCT03012087|"~     The aim of this study is to pilot test a web-based, patient-centered educational program~     that encourages the patient to have an informed discussion about pain medication options~     with their emergency department (ED) provider.~   "
3450|NCT03012074|"~     This study will use mobile health technologies to provide everyday data to help patients and~     their care providers better understand illness dynamics and develop adaptive approaches to~     improve health outcomes in diabetes. Specifically, the study will identify strategies to~     help patients adapt using multiple types of self-generated diabetes-related data and help~     providers guide patients to better self-manage in real-time, when guidance is needed most.~   "
3451|NCT03012061|"~     This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25~     mcg on lung function versus placebo after 24 weeks of treatment. This study will provide~     important information regarding the efficacy and safety of UMEC when administered in a~     separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase~     IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,~     safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects~     with asthma that is not well controlled. Eligible subjects will be requested to participate~     in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,~     screening/run-in, randomization/treatment and safety follow-up). The total number of~     randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to~     each of the 3 double-blind treatment arms.~   "
3452|NCT03012048|"~     This project is a community-based randomized controlled trial designed to test the~     effectiveness of two point-of-use water treatment technologies to improve clean drinking~     water access, reduce enteropathogen burden, and improve child growth among children in~     Limpopo, South Africa.~   "
3453|NCT03012035|"~     This study evaluates the role of treatment success expectation in spider fearful individuals~     on the actual treatment success. Half of participants will have positive treatment success~     expectations, while the other half will have neutral treatment outcome expectations.~   "
3511|NCT03011281|"~     The objectives of this single center, prospective, non-interventional inception cohort is to~     understand patient characteristics, general treatment patterns, effectiveness, and safety of~     Tofacitinib for rheumatoid arthritis patients in the real-world setting.~        1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib~        2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean~          RA patients.~        3. To further evaluate safety, effectiveness and demographic characteristics of the~          patients treated with Tofacitinib matched with and compared to biologic DMARDs from the~          BIOPSY registry database.~   "
3454|NCT03012022|"~     The purpose of this research study is to investigate the role of chemical reactions, such as~     inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function~     properly). The investigators are interested in studying the various chemical pathways for~     cell damage to determine which are the most prevalent and/or most important. The~     investigators also want to determine whether waste products of oxidative damage or other~     chemicals can be monitored in the blood or urine and serve as an indication of the existence~     and severity of overall heart disease activity. The investigators further want to determine~     whether certain proteins, called enzymes, affect this cell damage, or whether the presence~     or absence of certain genes which create different forms of these enzymes correlate with the~     development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in~     heart muscle structure) or other cardiovascular diseases.~   "
3455|NCT03012009|"~     Photodynamic therapy (PDT) is a well established treatment option for superficial non~     melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease~     (BD). However, a limited uptake of the topically applied photosensitizer methyl~     aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide~     (CO2) laser has recently been studied in order to enhance the skin penetration of this~     photosensitizer. This study compares the results of a full ablative and a fractional~     ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The~     endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve~     months of follow up.~   "
3456|NCT03011996|"~     Cohort 1~      To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of~     CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.~      Cohort 2~      To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420~     in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active~     control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.~   "
3457|NCT03011983|"~     This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain~     injury and to improve understanding of the biological basis of brain pathology in~     adolescents with concussion. Adolescents with a concussion will undergo neuroimaging and~     neuropsychology assessments acutely and four months after injury.~   "
3458|NCT03011970|"~     The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala~     response vary as a function of treatment dose and dose-test latency.~   "
3459|NCT03011957|"~     MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy~     (ART) and demographically matched uninfected adults to evaluate muscle and aging.~   "
3460|NCT03011944|"~     A nutrition-focused QIP will be implemented as standard of care at select branches of the~     home health division of the health care system. The QIP will be comprised of two groups of~     patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being~     discharged to home health, and Group 2 will consist of outpatients at-risk/malnourished~     patients enrolled in home health. Both groups will be followed for 90 days post enrollment.~     The QIP groups will be compared to historical controls, concurrent controls, and matched~     concurrent controls across other sites within the health system.~   "
3461|NCT03011931|"~     To study the correlation between simvastatin metabolism by the enterocyte and the histologic~     state of the intestine in treated celiac disease.~   "
3462|NCT03011918|"~     Falls and falls related injuries are considered one of the most adverse events that a~     patient can experience. Several assessment instruments to assess and mitigate risks for~     falls have been developed. However, these instruments have not addressed nutritional risk~     factors.~      Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in~     the hospital setting is a significant concern and may play a role as a fall risk factor.~      The World Health Organization (WHO) maintains a global anemia database. WHO has identified~     iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread~     nutritional deficiency worldwide. Anemia is present in 30% of the worlds population~     including industrialized nations.~      The consensus statement of the Academy of Nutrition and Dietetics / American Society of~     Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of~     inadequate intake along with a multitude of other factors. Weight loss occurs at multiple~     points along this continuum.~      this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss~     and degree of Hgb decline may be fall risk factors.~   "
3463|NCT03011905|"~     Many patients have strong pain at brachial plexus block resolution after operations for~     distal radius fractures with a volar plate. This study investigates if a single dose of~     dexamethasone in addition to a standard pain regime have an effect on postoperative pain.~     The primary endpoint is difference in the highest pain score first 24 hours after surgery.~     The investigators will also look at pain scores and analgesics consumption first few hours~     after surgery and at different times up to 2 years after surgery.~   "
3464|NCT03011892|"~     The purpose of this study is to establish the efficacy of each strength of INCB018424 cream~     once daily (QD) or twice daily (BID) in subjects with atopic dermatitis as compared with~     vehicle cream BID.~   "
3465|NCT03011879|"~     The program is to improve STEMI medical care quality in China. With the documents issued by~     National Health and Family Planning Commission of the People's Republic of China, the~     program was initialed in at least 200 primary PCI capable hospitals together with hundreds~     of adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom~     onset within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30~     patients will be enrolled consecutively from each PCI-capable center initially and from~     non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary~     PCI capable hospitals will be enrolled and all of them will be followed up for 1 year. Key~     performance indicators (KPIs) in STEMI care will be collected using both national PCI online~     registry and a program STEMI online registry database for the purpose of improvement of~     medical care. Hospital KPIs rank report and problem-based resolution will be feedback to~     each hospital after data analysis in each period. Comparison of every two cross-sectional~     data (self) and within one cross-sectional (inter-hospital) data will be used to evaluate~     the improvement of medical quality.~   "
3841|NCT03006939|"~     Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes~     survival in late-stage ovarian cancer patients. Little is known about the intraoperative~     fluid balance and its impact on morbidity and mortality.~   "
3466|NCT03011866|"~     Multilevel decompression and bone graft fusion is a most effective measure for treating~     degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large~     amount of perioperative blood loss and high demand for homologous blood transfusion.~     Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in~     various kinds of surgeries. However, high quality evidence of its efficacy and safety is~     still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of~     thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the~     optimal drug delivery route of TXA remains undetermined. The aim of this study is to test~     the non-inferiority of topical TXA application to its intravenous use in multilevel~     decompression and bone graft fusion surgeries. A prospective, randomized, double-blind,~     head-to-head comparison study design will be adopted.~   "
3467|NCT03011853|"~     Observational cohort study of mid-to-long term survival of patients with acute on chronic~     obstructive pulmonary disease, analyzed per type of ventilation support provided during~     first 24 hours in intensive care.~   "
3468|NCT03011840|"~     This study aims to understand the benefits of imparting pre operative instructions through~     written leaflets. The influence on the number of avoidable postponements and delay is also~     studied.The study is restricted to patients undergoing Head & Neck procedures under General~     Anaesthesia, at the minor OT complex at Tata Memorial Hospital~   "
3469|NCT03011827|"~     Thromboelastometry better assess coagulation than standard coagulation test in patients~     undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study~     recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly~     predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ;~     suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product~     administration. The aim of the study is to validate this result in a prospective cohort of~     patients submitted to ortothopic liver transplantation.~   "
3470|NCT03011814|"~     This phase I/II trial studies the best dose and side effects of durvalumab and to see how~     well it works with or without lenalidomide in treating patients with cutaneous or peripheral~     T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies,~     such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs~     used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving durvalumab and lenalidomide may work better in treating patients~     with cutaneous or peripheral T cell lymphoma.~   "
3471|NCT03011801|"~     This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among~     pregnant women with elevated depressive symptoms. Half of the women will be randomized to~     receive IPT, and the other half will get Treat As Usual, provided via behavioral health in~     the hospital.~   "
3472|NCT03011788|"~     The aim of this randomized trial is to compare the proportion of patients achieving an~     adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation~     regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2~     consecutive days in a population identified as high risk for an inadequate bowel~     preparation.~      2. Research Design: This study is a single-center prospective randomized study at the West~     Haven VAMC.~      3. Methodology:~        1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation~          Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left,~          transverse, and right).~        2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated~          polyp/adenoma detection rate, patient tolerability of preparation using the validated~          Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related~          to bowel preparation~      Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high~     risk for poor bowel preparation,~   "
3473|NCT03011775|"~     Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the~     peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ~     regulates carbohydrate and lipid metabolism, immune and inflammatory responses in heart~     tissues.~      Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course~     of atherosclerosis and coronary heart disease (CHD).~      The study will include 43 patients with coronary artery disease. Patients will be divided~     into the study group - 20 patients, in whom pioglitazone will be included in the combined~     therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23~     patients receiving standard complex drug therapy over 6 months. Patients will be underwent~     clinical examination, ultrasound of neck vessels, study of carbohydrate and lipid~     metabolism.~      The end primary points of the study will be the onset of death due to myocardial infarction,~     coronary revascularization procedures (coronary artery bypass grafting (CABG) or~     percutaneous coronary intervention (PCI)), or hospitalization for acute coronary syndrome~     (ACS) or unstable angina (UA).~      Predefined secondary end points included carotic atherosclerotic leisure (carotic~     intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic~     inflammation level (the level of C reactive protein), lipid metabolism (levels of serum~     total cholesterol, triglycerides, high and low density lipoproteins), level of insulin~     resistance ( oral glucose tolerance test, blood glucose).~   "
3474|NCT03011762|"~     Sleep apnea is a condition in which the throat air passage closes during sleep and~     repeatedly interrupts breathing. The standard treatment of sleep apnea is air pressure~     applied to the nose, so-called nasal CPAP, but it is not suitable for all patients. Another~     treatment is to use a dental appliance while asleep. In this treatment, an appliance covers~     the upper and lower teeth and acts to pull the jaw forward, which opens the throat passage.~     This allows the patient to breathe normally.~      Dental appliance treatment does not work effectively in all patients. In order to identify~     those in whom dental appliance therapy will be effective, the study sponsor has invented the~     remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized~     dental appliance which is used overnight in hospital sleep studies and works by pulling the~     jaw outward under the control of a technician.~      In order to eliminate the need for an overnight in hospital sleep study, the sponsor has~     invented a new device that allows for the identification of individuals who are suitable~     candidates for dental appliance therapy from the comfort of the home. Like with MATRx,~     participants will sleep with a motorized mandibular positioner in place. But, it is~     controlled by a computer, rather than a sleep technician, making it a computer controlled~     mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing~     using the CCMP will be evaluated through participation in this study.~      The sponsor has carried out two previous research trials leading to the development of the~     CCMP. The first established the predictive accuracy of the remotely controlled mandibular~     positioner at identifying candidates suitable for oral appliance therapy and their effective~     therapeutic setting. The second established the accuracy of the algorithms used by the CCMP~     to similarly identify successful candidates in a clinical setting. No significant problems~     were identified in conjunction with our previous research protocol, and no significant risks~     were identified. This third protocol is to establish the feasibility and accuracy of the~     CCMP when used in the home setting.~      The trial will utilize data collected over a series of nights to formulate a prediction of~     therapeutic outcome with an oral appliance. The prediction will be tested by comparing the~     degree of airway obstruction without treatment (from data collected prior to the study) to~     the degree of airway obstruction with oral appliance therapy. A custom fit oral appliance~     will be provided to participants as part of the trial.~      The purpose of the study is to test the predictive accuracy of the CCMP in identifying~     favorable candidates for oral appliance therapy and in determining an efficacious protrusive~     position. Another purpose is to evaluate the convenience and possibility of carrying out a~     multi-night CCMP study in the home.~      There are no known risks or side effects to the CCMP studies, to the home studies, or to the~     oral appliance therapy. It is possible that participants will have some discomfort during~     the nights of the CCMP studies but this will be transient and not cause any long term~     damage. Participants may experience soreness of the teeth or jaw joint during adjustment of~     the oral appliance by the dentist. There is no risk of jaw dislocation or problems with the~     temporomandibular joint (TMJ).~      Participants will have the benefit of receiving a dental appliance for treating their sleep~     apnea at no charge. This will be supplied to participants by a dentist who is an expert in~     this field. Participation in the study will also allow the further development and~     ultimately commercialization of the CCMP device which may help individuals who have sleep~     apnea.~      Dental appliance therapy is just one of two therapies for sleep apnea. If participants~     choose not to have the dental appliance therapy, they may wish to try nasal continuous~     positive airway pressure. Participants may withdraw at any time during the study without~     compromising their health care in any way. To withdraw, participants should simply notify~     one of the physicians or the research assistant. If the sponsor obtains new information that~     might affect an individual's willingness to participate in the study, they will be informed~     immediately.~   "
3475|NCT03011749|"~     The aim of the study is to investigate whether positron emission tomography (PET) using the~     tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone~     marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of~     hematological toxicity~   "
3476|NCT03011736|"~     This clinical trial studies the omission of intact parathyroid hormone testing during~     surgery in treating patients with primary hyperparathyroidism. Omission of intact~     parathyroid hormone testing during parathyroid gland removal may help patients with primary~     hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time~     and cost of surgery.~   "
3477|NCT03011723|"~     This study evaluates the effect and process of individualized music therapy for~     home-dwelling persons with mild to moderate dementia. The music therapy is administered~     individually and includes a close caregiver. Memory of familiar music is found to be~     retained in persons with dementia. It is assumed to facilitate autobiographical memories and~     stimulate interaction with significant others. Based on time series analyses we will use~     statistical process control to evaluate when and how change occur.~   "
3478|NCT03011710|"~     Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco~     smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently~     referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use~     and awareness of these devices has grown exponentially in recent years, with millions of~     people currently using them.~      The benefits and risks of electronic cigarette use are uncertain. There is no research on~     the acute oral effects of electronic cigarette in the scientific literature and no hungarian~     epidemiological survey has been performed in this topic.~      Regulation of electronic cigarettes varies across countries in the European Union, ranging~     from no regulation to banning them entirely.~      The investigators research could help to integrate the regulation of this device in Hungary~     and in the EU as well.~      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey~     would be novel in this topic.~   "
3479|NCT03011697|"~     Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has~     brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart~     disease are not so clear, especially in the developing countries such as China etc. Because~     of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed~     on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe~     valvular diseases are very common in China. Hence, we design a prospective, observational~     cohort study to provide contemporary information on the prevalence, characteristics, risk~     stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult~     patients with valvular heart disease.~   "
3480|NCT03011684|"~     Iatrogenic infertility as a result of cancer treatment has a profound effect on long-term~     quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to~     cancer treatment has been associated with improved quality of life, with a potential ability~     to reduce long-term decision-related regret in cancer survivors. Though letrozole plus~     gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in~     ovarian stimulation cycles for fertility preservation in patients with~     estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to~     improved oocyte yield. Improved knowledge about the efficacy of these medications, with~     regard to oocyte yield, has the potential to significantly improve quality of life in~     reproductive-age breast cancer survivors.~   "
3481|NCT03011671|"~     We hypothesize that ACZ can be safely administered concomitantly with TMZ in patients with~     malignant glioma and that this regimen improves patient survival without increasing toxicity~     to an unacceptable level. Information gathered from this study will contribute towards the~     development of a future larger phase II study in these tumors.~   "
3482|NCT03011658|"~     Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a~     still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown~     prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian~     population. 75% of patients with cutaneous lichen planus also experience oral lesions and~     may be precipitated or exacerbated by psychosocial stressors.~      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in~     the body, the most common effect of which is increased cortisol level in blood. This hormone~     is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of~     carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a~     decisive index in stressful situations.~      This study is intended to correlate the serum cortisol levels with anxiety and depression in~     patients with symptomatic oral lichen planus. This study attempts to evaluate psychological~     anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression~     Scale ( HADS) and correlating with their serum cortisol levels.~      To understand and explore the etiopathogenesis for better management of oral lichen planus.~   "
3483|NCT03011645|"~     The purpose of this study is to identify gene variants that increase risk of cardiovascular~     disease (CVD) and type 2 diabetes, particularly genes related to stress factors.~   "
3484|NCT03011632|"~     The project is intended to be realised in two phases. In the first stage, a case control~     study will be performed. In the second phase, double-blind, placebo controlled study will be~     conducted. In the first phase 3 groups of children will be compare: i) a group of children~     suffering from chronic rhinosinusitis (CRS) (fulfilling the European Position Paper on~     Rhinosinusitis and Nasal Polyps (EPOS) criteria) and asthma (fulfilling the Asthma~     Predictive Index (API) criteria) (CRS+/asthma+, n=90), ii) a group of children suffering~     from CRS (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria)~     (CRS+/asthma-, n=30) and iii) a group of children without symptoms of CRS (negative EPOS~     criteria) and without asthma symptoms (negative API criteria) (CRS-/asthma-, n=30). In the~     second phase the effect of intranasal glucocorticosteroids will be assessed. The following~     research methods will be used: CRS-symptom score questionnaire (SN-5) and Childhood Asthma~     Control Test (cACT) questionnaires, skin prick test, spirometry, measurement of nitric oxide~     NO in exhaled breath (FeNO), taste perception test, eosinophil morphology assessment, ratio:~     glucose concentration in nasal secretion/serum glucose level, concentration of specific~     immunoglobulin (Ig) E, total immunoglobulin G (IgG) and immunoglobulin A (IgA), the~     proportion of innate lymphoid cells (ILC) and regulatory lymphocytes cells in the peripheral~     blood. Endoscopic examination of the upper airways will be performed and samples of the~     mucosa will be taken. The mucosal examination will be as follows: i) polymerase chain~     reaction (PCR) examination for the detection of the presence of viral and bacterial genetic~     material, ii) measurement of the expression of the various messenger ribonucleic acid~     (mRNA), iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition~     (EMT) genes and iv) percentage of ILCs.~   "
3485|NCT03011619|"~     Moderately to severely depressed subjects will be randomized to the Control Group, who~     will receive care as usual, or the CBT Group, who will receive care as usual in addition~     to the manualized course of Cognitive Behavioral Therapy (CBT).~   "
3512|NCT03011268|"~     The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha~     (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the~     option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF~     treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF~     treatment after a relapse~   "
3513|NCT03011255|"~     Immunotherapy is now considered to be one of promising approaches for treating cancer.~     Radiation therapy has been to be a cornerstone treatment for unresectable advanced~     esophageal cancer. Radiation-induced mutation genes were identified as new sources of tumor~     associated antigens using exon sequencing and peptide microarray technologies. Epitope~     peptides for these targets are able to induce peptide specific cytotoxic T lymphocytes~     (CTL). In this clinical trial, investigators evaluate the efficacy and safety of peptide~     specific CTL therapy in combination with radiation therapy in treating patients with~     unresectable, advanced or recurrent esophageal cancer.~   "
3486|NCT03011606|"~     The toxicity of traditional prostate cancer therapies including radical surgery and external~     beam radiation is well known. This has prompted a move towards focal therapy where only the~     cancerous part of the prostate is treated.~      To date, studies have demonstrated very promising outcomes following focal therapy with the~     majority of men maintaining their urinary and sexual function after therapy.~      In a small proportion of men, disease recurs after focal therapy. The optimal treatment for~     men with recurrent disease after focal therapy is yet to be defined. Patients may undergo~     further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland~     therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU)~     or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate~     is removed.~      To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after~     focal therapy has not been formally studied.~      Traditionally, the side effects of surgery and radiation therapy performed in patients that~     have already undergone previous prostate cancer treatment have been considerable with high~     rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a~     significant area of the prostate untreated, the investigators believe surgery after focal~     prostate therapy will be associated with a much lower incidence of urinary and sexual~     dysfunction.~      The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in~     men that have undergone prior focal ablation therapy. In addition, the investigators wish to~     perform a number of basic science studies to attempt to better understand why the patient~     has experienced recurrent prostate cancer after focal therapy.~   "
3487|NCT03011593|"~     This study assessed the effect of a nutrition support product on quality of life in adults~     with compromised gut function and malabsorption.~   "
3488|NCT03011580|"~     This Strategic Research Project is a translational proof-of-concept study that will~     determine whether vitamin D3 has potential to prevent recurrent tuberculosis (TB), as~     indicated by enhanced resolution of pulmonary inflammation detected using 18F-FDG PET-CT~     scanning. The extent of pulmonary inflammation detectable on PET-CT scanning is a validated~     biomarker that has previously been shown to predict risk of TB recurrence in patients taking~     anti-TB treatment. The investigators propose to explore whether vitamin D3 can enhance~     resolution of PET-CT-detectable pulmonary inflammation, on the basis of extensive~     preliminary data from in vitro studies and a Phase 2b clinical trial that the investigators~     have conducted, showing that high-dose vitamin D3 accelerates resolution of peripheral blood~     inflammatory responses in patients with pulmonary TB.~      Forty vitamin D-deficient patients who have completed 6 months' TB treatment, but who still~     have residual pulmonary inflammation detectable on PET-CT scanning, will be allocated to~     receive either an 8-week course of high-dose oral vitamin D3 supplementation or placebo~     during the study period. The extent of pulmonary inflammation on PET-CT scanning will be~     compared between intervention vs. control groups at 8-week follow-up.~      If the study shows a positive result, it will generate valuable proof-of-concept data that~     could be used to support an application to conduct a large phase 3 trial of vitamin D~     supplementation to prevent TB recurrence.~   "
3489|NCT03011567|"~     This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs)~     administered during the postpartum period influence blood pressure in women with~     hypertensive disorders of pregnancy. The study design is a prospective double blinded~     randomized control trial with participants randomized to receive postpartum analgesic~     regimens with and without NSAIDs.~   "
3490|NCT03011554|"~     VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is~     indicated for monocular implantation to improve vision in eyes of patients at least 65 years~     of age with severe to profound vision impairment caused by bilateral central scotomas~     associated with end-stage age-related macular degeneration (AMD).~      Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular~     lens placement are currently contraindicated for telescope surgery.~      These patients have no viable therapy available to improve their vision.~      The objective of the TES pilot study is to evaluate the safety and effectiveness of~     implanting the intraocular telescope for improving vision in patients with bilateral~     end-stage age- related macular degeneration who are pseudophakic.~   "
3491|NCT03011541|"~     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the~     treatment of retinal and optic nerve damage or disease.~   "
3492|NCT03011528|"~     Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the~     second decade of life. They start most often from bone, and are characterized by a specific~     translocation involving the so-called EWS gene. In one patient out of three, the staging~     procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and~     bone marrow.~      ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local~     treatment, and consolidation chemotherapy.~      The primary metastatic dissemination is the most important prognostic factor, as the~     survival rate is around 70-75% for localized tumours, in contrast with less than 50% for~     patients with primary metastatic disease.~      Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the~     prognosis of these patients. While the long-term survival of patients with isolated pleural~     pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with~     bone marrow involvement.~      In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing~     tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3~     patients), the protocol proposed a heavy induction chemotherapy, in order to propose a~     consolidation with high dose chemotherapy to a higher rate of patients. The high-dose~     Busulfan Melphalan chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140~     mg/m²), with autologous peripheral blood stem cell (PBSC) support.~      Of note, for the full population of patients with metastatic disease, the 3-year EFS rate~     was 27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after~     diagnosis, and a median survival time of 1.6 years.~   "
3493|NCT03011515|"~     The purpose of this study is to validate the diagnostic accuracy of a novel host-response~     based diagnostic tool for differentiating between bacterial and viral etiologies in adult~     patients aged 18 years and older with clinical suspicion of lower respiratory tract~     infections (LRTI)~   "
3842|NCT03006926|"~     This is an open-label Phase 1b study designed to evaluate the tolerability and safety of~     lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma~     (HCC).~   "
3494|NCT03011502|"~     Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota~     imbalance, host-microbiota crosstalk dysfunction and inflammation.~      As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly~     interested in patients with Bone and Joint Infections (BJI). These patients are treated with~     antibiotics having significant consequences on their intestinal flora, causing intestinal~     discomfort, which can be manifested by diarrhea.~      MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof.~     Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections~     Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI).~     The objective of this study is to follow patients with treated BJI in order to characterize~     intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota~     Transplantation (aFMT) intervention.~      To do this, patients will be monitored according to the current CRIOAc recommendations, with~     the aim of taking biological samples from patients at the same time as scheduled visits,~     routine monitoring patients. Only one additional consultation will be carried out 15 days~     after stopping the antibiotics in order to better evaluate the dysbiosis evolution.~      Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up~     consultations over a period of 6 months.~   "
3495|NCT03011489|"~     10 newborns with unilateral cleft lip/ palate will treated pre-surgically by Vacuum formed~     aligners in order to evaluate its effect on Nasoalveolar molding~   "
3496|NCT03011476|"~     Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson~     disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase~     inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the~     influence of AchEI on a brain network for gait and balance in PD. As gait problem is~     prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus~     on the patients with PIGD phenotype.~   "
3497|NCT03011463|"~     The purpose of the study is:~        -  to determine absolute bioavailability, input rates, distribution volume, renal and~          intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and~          rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or~          rs12208357~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1~          rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor~          ranitidine~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1~          rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein-~          inhibitor clarithromycin~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1~          rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor~          clarithromycin.~   "
3498|NCT03011450|"~     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients~     With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal~     Impairment.~   "
3499|NCT03011437|"~     There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori)~     infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly~     developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by~     enhancing color contrast of the mucosa. The aim of the study is to investigate the ability~     of LCI for diagnosing H. pylori infection compared with WLI.~   "
3500|NCT03011424|"~     Early postoperative extracorporal liver support therapy (ELS) as a tool to manage post~     hepatectomy liver failure (PLF).~      Post-operative liver failure (PLF) has been identified as a major risk factor leading to~     increased morbidity and mortality. The incidence of PLF varies largely between 0-30%, and~     may be accounted for the main reason of postoperative mortality related to liver surgery~     (reported figures ranging from 18 to 75 %).~      Currently, there are only a few treatment options for PLF, mainly restricted to the~     treatment of complications like bile leakage, infections as well as the prevention of~     further liver damage caused by e.g. thrombosis or haemorrhage as well as administration of~     liver toxic drugs. Recently the international study group on liver surgery (ISGLS) published~     criteria for a new definition of PLF which will greatly facilitate the comparison of results~     from future studies on a variety of aspects on liver failure.~      ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified~     haemodialysis that allows the removal of water-soluble and protein bound toxins over an~     albumin-coated high flux membrane against recycled exogenous albumin. Thus, MARS can support~     the compromised detoxification capacity of the liver as well as improve physiological~     parameters. This would offer the potential for temporary support for the harmed liver after~     liver resection allowing for a more uneventful recovery.~      For obvious reasons previous reports contain few patients, present heterogonous treatment~     groups and all suffer from lack of standardized treatment protocols. Few if any surviving~     patients, thus providing no evidence to encourage ELS as a possible treatment option for~     patients suffering of PLF. However, studies with defined patient populations and treatments~     according to a predefined standardised treatment protocol are warranted.~      Primary issues to be addressed:~        1. Can ELS be applied in an early phase of PLF?~        2. Is ELS safe and feasible for the treatment of PLF when practised according to a~          predefined protocol?~      Secondary issues to be addressed:~        1. The development of predictive laboratory-chemical markers of liver failure~        2. Indirect measures of portal flow and portal pressure~        3. Indocyanine green clearance (ICG) under ELS treatment~        4. Clearance of toxic products as assessed in aliquots taken from the dialysate~   "
3501|NCT03011411|"~     Pragmatic study comparing historical data from usual collection tools to medical~     administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to~     the data collection:~        1. Collection of hospitalization data from the local PMSI and outpatient data from CRF~        2. Collection of hospitalization data in the national PMSI with a probabilistic matching~          between local and national PMSI data~        3. Collection of outpatient consumption data from SNIIRAM after matching of data from the~          national PMSI to the SNIIRAM.~   "
3502|NCT03011398|"~     The purpose of the Registry study is to observe the improvement in subject-reported clinical~     outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.~   "
3514|NCT03011242|"~     The Investigators will examine if DC-STAMP can serve as an early marker of TNFi response in~     PsA. Identification of such a biomarker would permit rapid transition to a new agent, a~     major treatment advance. TNFi are the most effective therapies in PsA, however, methotrexate~     is frequently initiated early in the disease course based on its significantly lower cost.~     Unfortunately, the efficacy of MTX has not been supported in clinical trials and up to 40%~     of patients do not respond to TNFi therapy. Moreover, valid biomarkers to predict MTX or~     TNFi responses are currently unavailable. This study may also provide the first data on the~     comparative efficacy of MTX and TNFi using clinical, Power Doppler Ultrasound (PDUS) and~     biomarker outcomes.~   "
3503|NCT03011385|"~     OBJECTIVE: The project aims at investigating of the effects of three types of planning~     (individual planning, collaborative planning, and dyadic planning) on physical activity~     among dyads.The influence of three planning interventions are compared with an active~     control condition, including physical activity education.~      PARTICIPANTS: The effects of the interventions are evaluated among dyads of two adults~     (partner-partner dyads). Adults forming dyads (e.g. two romantic partners, two relatives,~     two co-workers, two friends) who are in regular contact for at least one year will be~     enrolled. A minimum of 50 dyads enrolled into the each arm of the trial (a total of 200~     dyads). The interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
3504|NCT03011372|"~     The purpose of this study is to evaluate the efficacy and safety of INCB054828 in subjects~     with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1~     rearrangement.~   "
3505|NCT03011359|"~     Colon resection is one of the major surgery, the postoperative pain is so severe that it is~     necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The~     most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively~     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce~     the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,~     which leads to the adverse effects in patients who are very sensitive to narcotic~     analgesics. And the patient's satisfaction to the PCA may be low.~      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode~     setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out~     time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a~     new mode, so that the administered rate and amount of drug can be increased or decreased~     according to the patient's use of bolus button. Therefore, this PCA device can be~     implemented to the conventional mode, and added the function of automatically controlling~     the basal rate and administered amount of drug according to the use demand of the patient.~     However, since there are few studies related to this new mode of PCA, more research is~     needed in patients with postoperative pain.~   "
3506|NCT03011346|"~     Transcatheter aortic valve implantation (TAVI) is an established treatment option for~     patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic~     valve replacement (SAVR). Many novel devices are currently being developed and established~     transcatheter heart valves undergo design reiterations to address limitations and reduce~     complication rates associated with the device and implantation procedure. However, device~     comparisons by use of randomized trials are scarce in particular for newer generation~     transcatheter valves. The aim of this study is to assess non-inferiority of the~     self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards~     SAPIEN 3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical~     efficacy at 30 days.~   "
3507|NCT03011333|"~     This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,~     multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic~     efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via~     ultrasound-guided lateral and medial pectoral nerve block before surgery.~   "
3508|NCT03011320|"~     This study looks to enroll subjects with ovarian cancer who will be having standard of care~     surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe~     how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the~     tumor will also be studied. This study will also help us compare the amount of EC1456 seen~     in tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission~     tomography (SPECT) or single-photon emission tomography with in-line x-ray computed~     tomography (SPECT/CT).~      All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior~     to EC1456 administration.~      Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively:~        -  4 mg/m2~        -  8 mg/m2~      EC1456 will be administered at 1 of the following 2 time points:~        -  <8 hours before planned surgery~        -  48±4 hours before planned surgery~      Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again~     right before surgery. At the time of surgery, tumor samples will be removed and sent to~     Endocyte for analysis.~   "
3509|NCT03011307|"~     The purpose of this study is to determine the effect of intrathecal oxytocin on speed of~     reduction in pain for the first 60 days after hip surgery.~   "
3510|NCT03011294|"~     Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative~     impact not limited to the patients but also to the partner that sleep in the same bed. Is it~     reasonable to speculate that the partner suffer sleep deprivation, increased level of~     irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA~     patient. Although previous data reported impaired sleep quality in partners of patients with~     OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the~     treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the~     improvements in the subjective and objective sleep. Thus, the main objectives of this~     randomized controlled study are: to evaluate the impact of three months of randomization~     (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure~     (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and~     sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of~     patients with moderate to severe OSA and a recent diagnosis of Metabolic Syndrome (MetS)~     according to the ATP III criteria derived from an ongoing randomized study conducted in our~     Institution.~   "
3515|NCT03011229|"~     The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic~     ultrasound (EUS) biopsy needle to the current standard EUS needle.~      The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is~     possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60%~     yield with the current needle.~   "
3516|NCT03011216|"~     The present study examines whether a computerized cognitive control training as compared to~     a placebo (fake) training will reduce the frequency of depressive rumination in depressed~     individuals. Rumination has been identified as a major risk factor for the onset and~     recurrence of depressive episodes and it has been suggested that it is linked to deficits in~     cognitive control functions. It is thus expected that training cognitive control will reduce~     the frequency of rumination as well as ameliorate its detrimental effect on negative mood~     states.~   "
3517|NCT03011203|"~     The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can~     boost muscle mitochondrial function in vivo.~   "
3518|NCT03011190|"~     Borderline personality disorder (BPD) is the most prevalent personality disorder in young~     community population whose most severe complication is suicide. Pharmacotherapy should not~     be used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the~     main treatment for people with BPD and the current recommendation is adapting available~     comprehensive treatments to develop easier and briefer therapies that are also effective.~     Iconic Therapy is an innovative option whose good clinical results should be validated on a~     clinical trial.~   "
3519|NCT03011177|"~     To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 DM~     patients.~   "
3520|NCT03011164|"~     Some researches have found that gait posture velocity have influence on kinematic~     parameters. However, how the gait velocity and posture will influence kinematic parameters~     remain unclear. In addition to walking, running is one of the most daily activities of~     people. The purpose of this research is to find out the influence of gait velocity and~     running to kinematic parameters . To do this, it will provide a reference for future~     prospective studies or investigations and make us fully understand the impact of gait~     velocity and running to kinematic parameters of gait.~   "
3521|NCT03011151|"~     Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill~     children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier~     integrity, is associated with significant morbidity in critical illness. The mechanisms~     underlying GI dysfunction in critical illness are not well understood. GI dysfunction in~     surgery and critical illness has been associated with inflammation. There is evidence to~     suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI~     dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI~     motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically~     GI serine proteases and zonulin, released under conditions of inflammation. In this study~     the investigators will examine the relationship between inflammation and PAR2 activation by~     PAR2 agonists and subsequent GI dysfunction in pediatric critically ill surgical patients.~     The overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine~     proteases and zonulin, released due to inflammation results in gastric dysmotility and loss~     of epithelial barrier integrity. In this study, the investigators will examine whether PAR2~     agonist expression is increased and correlates with GI dysfunction in critically ill~     surgical pediatric patients. This proposal fills a knowledge gap in the understanding of~     mechanisms for GI dysfunction in critical illness, and will be applicable to all surgical~     and medical critically ill children.~   "
3522|NCT03011138|"~     Previous reports have the evidence implicating gait velocity may affect kinematic~     parameters. However, how the gait velocity will influence kinematic parameters remain~     unclear. The purpose of this research is to find out kinematic characteristics among~     different gait velocity. To do this, it will provide a reference for future prospective~     studies or investigations and make us fully understand the impact of gait velocity.~   "
3523|NCT03011125|"~     This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase~     1 clinical trial. This study will determine the safety and side-effect profile of an~     investigational dexlansoprazole injection after single intravenous administration in healthy~     Chinese adults.~   "
3524|NCT03011112|"~     There is little study focusing on kinematic parameters in the assessment of the symptomatic~     and functional severity of knee osteoarthritis (KOA). The purpose of this study is to~     evaluate the correlations between kinematic parameters and the severity of symptoms and~     functions in patients with KOA.~   "
3525|NCT03011099|"~     The purpose of this study is to investigate whether robotic exoskeleton training can improve~     walking performance after SCI as compared to conventional physical therapy.~   "
3526|NCT03011086|"~     The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had~     been suggested as one of the factors but remains unproven.~      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients~     to pave a way for new arena of treatment with the etiology of this persistent condition~   "
3527|NCT03011073|"~     Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system~     has image processing and left ventricular function quantification software which are~     different from the precedent model Philips IE33.Left ventricular function quantification and~     myocardial distortion are the main medical examination influencing doctor's decisions.~      EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial~     distortion quantification software also has been modified with new cut off and different~     calculation method.~      The aim of this study is to compare the quality of images and the quantification of cardiac~     ejection fraction with these new software in order to choose the more reliable and~     reproducible for patient.~   "
3528|NCT03011060|"~     This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by~     Capecitabine could achieve additional benefits over traditional postoperative chemotherapy.~     In the study group, patients that do not achieve pathological complete response(pCR) will~     receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group,~     patients will be treated with postoperative adjuvant chemotherapy.~   "
3529|NCT03011047|"~     Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach~     versus traditional trans-orbital surgical approach (control group) in orbital blow out~     fractures in terms of postoperative clinical and digital radio-graphical assessments.~   "
3530|NCT03011034|"~     The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of~     talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low~     or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during~     treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).~   "
3534|NCT03010982|"~     This is a Phase 1, open-label, two-part study designed to characterize the PK of an IV dose~     of approximately 12 µg tazemetostat that contains approximately 500 nCi of [14C]~     tazemetostat and the ADME of an oral dose of 800 mg tazemetostat that contains approximately~     400 µCi of [14C]-labeled tazemetostat in three subjects with B-cell lymphomas.~   "
3535|NCT03010969|"~     The aim of the clinical study is:~        1. to examine the association between postoperative endothelial function, indirectly~          measured by reactive hyperemia index, and major adverse cardiovascular events including~          cardiac death within 30, 90 and 365 days of acute abdominal surgery.~        2. to examine the association between postoperative endothelial function, indirectly~          measured by reactive hyperemia index, and non-cardiovascular complications including~          non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.~        3. to examine the importance of the postoperative blood glucose level and the pulmonary~          function for postoperative complications and death within 30, 90 and 365 days of acute~          abdominal surgery.~        4. to examine the association between postoperative endothelial function, pulmonary~          function and blood glucose level~        5. the qualitative part of the study will examine the postoperative subjective symptoms~          including acute and chronic pain, quality of recovery and functional status, depressive~          thoughts and post-traumatic stress disorder.~   "
3536|NCT03010956|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. The purpose of this study is to investigate changes in arterial~     stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes~     mellitus type 1 or type 2 after glycemic control by optimal medication.~   "
3537|NCT03010943|"~     Feasibility and tolerance study of virtual reality headset for brain mapping during brain~     awake surgery.~   "
3538|NCT03010930|"~     The purpose of this study is to determine how repeated dietary exposure to umami taste~     affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult~     subjects will consume a low glutamate vegetable broth daily for one month, where the~     experimental group's broth is supplemented with the umami-rich stimuli of monosodium~     glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).~      The investigators hypothesize that repeated dietary exposure to umami taste will:~        1. diminish umami suprathreshold intensity perception and hinder the ability to~          discriminate varying MSG concentrations~        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense~          umami stimuli~        3. decrease satiation and decrease the satiating effect of a test meal~   "
3539|NCT03010917|"~     This project represents a first step in examining the potential use of fish oil for the~     treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation~     of alcohol-induced sedative and stimulant effects, as well as cognitive effects and~     cerebellar effects in healthy social drinkers.~   "
3540|NCT03010904|"~     This study aims to investigate differences in digestion rates and gastrointestinal problems~     caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's~     milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and~     plasma cytokine levels.~   "
3541|NCT03010891|"~     The proposed 2-year study has two specific aims: (1) to examine the effects of a bundle of~     supportive interventions on preterm infants' stress (salivary cortisol and~     dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,~     and physical activity in the NICU, and (2) to explore the relationships among preterm~     infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,~     and physical activity. This randomized controlled trial will adopt a longitudinal~     repeated-measures design to examine the effects of bundled supportive interventions on~     preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and~     physiological signals of infant distress [using bedside electrocardiographic monitors]),~     sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.~     Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two~     conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine~     kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of~     supportive interventions (usual NICU care +positioning + gentle touch + modulating infant~     states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45~     minutes. Outcome variables will include infants' biological responses to stress (salivary~     cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and~     physical activity.~   "
3542|NCT03010878|"~     This was a randomized control trial of a yoga and self-management intervention for~     individuals with chronic pain. Participants were assigned to either a wait-list control~     group (self-management only), or a yoga intervention (self-management and yoga).~     Self-management education session occurred monthly within the community. Group yoga~     intervention was delivered two times a week with a specifically designed program that was~     progressively more difficult. Assessments were then administered pre and post intervention,~     and a semi-structured interview was completed following the intervention. Quantitative and~     qualitative data were then compared between groups.~   "
3543|NCT03010865|"~     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel~     treatment for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its~     effects on improving symptoms and functioning in SZ, and the relationship of the drug's~     clinical effects to epigenetic and inflammation related biochemical changes.~   "
3544|NCT03010852|"~     Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are~     common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and~     even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its~     success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on~     patient compliance with IS effort and frequency. The investigators hypothesize that a~     focused education preoperatively on IS for POH and intensive monitoring of patient~     compliance with IS therapy in the early postoperative period shortens postoperative oxygen~     therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery,~     compared to patients receiving standard of care.~   "
3855|NCT03006757|"~     The purpose of this study is to compare the effect of rapid heat cured acrylic resin~     material with titanium dioxide nanoparticles added to conventional acrylic resin material on~     the biting force of the single maxillary complete denture .~   "
3545|NCT03010839|"~     During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle.The~     myocardial injury is a serious complication ,which increases both mortality and morbidity of~     cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb~     ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive~     strategy.Recent some trials suggested that RIPC could provide myocardial protection by~     reducing serum cardiac biomarkers,however,whether the RIPC can improve the clinical outcomes~     in patients undergoing on-pump cardiac surgery,is still uncertain.~      The study hypothesis is: remote ischemic preconditioning will provide myocardial protection~     and improve clinical outcomes in patients undergoing cardic surgery.~   "
3546|NCT03010826|"~     The neural circuits in our brains require a layer of insulation in order to transmit signals~     in a rapid and efficient fashion. This insulation is called White Matter and is comprised of~     a specific type of brain cell called an oligodendrocytes. Damage to brain white matter~     occurs following injury and in disorders like Multiple Sclerosis and results in sensory,~     motor, and cognitive problems. Currently there are no effective medical therapies to promote~     brain repair and reduce disability following damage to white matter. In this project, we~     hope to change the situation by encouraging the brain itself to generate new~     oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to~     white matter growth.~   "
3547|NCT03010813|"~     This is a prospective, single center, multispecialty study that aimed to evaluate the~     clinical feasibility and safety of single port surgery and NOTES (mainly transanal and~     transoral surgery) using a novel single port robotic system.~   "
3548|NCT03010800|"~     This study will test the acute efficacy of an investigational device (Yoni.Fit) in a~     clinical trial of women with incontinence in a standardized set of challenges performed with~     and without the device in place.~   "
3549|NCT03010787|"~     A multi-part study to investigate the safety, tolerability and local and systemic~     pharmacokinetics of V565~   "
3550|NCT03010774|"~     Currently, all patients in the hospital are woken up throughout the night to check for vital~     signs, no matter how sick they are. The investigators are doing this study to determine~     whether skipping routine vital sign checks at night improves participant sleep quality and~     satisfaction without increasing the risk of adverse events.~   "
3551|NCT03010761|"~     No medication existed for BQ dependence. No clinical trials existed for the drug therapy.~     Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine~     oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as~     MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or~     antidepressants might reduce the BQ addiction severity.~      The investigators will conduct the randomization and double blinded with placebo controlled~     study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and~     throat (ENT) outpatient department (OPD). All participants shall agree the informed consent.~     The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use~     disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical~     Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and~     other substance use disorder except cigarettes are excluded. All participants receive the~     semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and~     Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention,~     the participants will finish their basic data, daily amount of cigarettes, betel nut,~     medical history and psycho-social rating scales. Next, in addition to counseling, the~     investigators will continue or modify the optimal antidepressants based on the previous~     results.~      The investigators will evaluate their BQ use condition as what has been measured in the~     natural observation study of the first year. The investigators will check the outcome~     measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown~     Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their~     hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline,~     2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if~     the participants also agree for the prediction of oral cancers.~   "
3552|NCT03010748|"~     Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used~     before and after clinical refractive surgery, we will collect the corneal morphological and~     biologic parameters of the population under refractive surgery screening in refractive~     surgery centers around the country, and construct corneal morphology database in different~     living areas of Chinese people. Based on this, compared with the suspected keratoconus and~     keratoconus population, the screening criteria and reference standards accord with the~     characteristics of keratoconus of Chinese ethnic will be achieved.~   "
3553|NCT03010735|"~     The purpose of this study is to investigate the effects of oral administration of~     Bifidobacterium animalis A6 on the metabolism of uremic toxins, in the patients with End~     Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a~     Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived~     uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome.~     The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal~     Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are~     also assessed.~   "
3554|NCT03010722|"~     This is a single centre prospective biological translational research study involving the~     collection of tumour tissue, blood samples and clinical data from patients being treated~     with regorafenib for metastatic Colorectal Cancer (mCRC) at the Royal Marsden Hospital.~     Patients will be eligible for the study if they have a histological diagnosis of CRC, are~     refractory to standard available therapies with palliative intent for mCRC, have received~     prior treatment with at least one anti-VEGF antibody and chemotherapy drugs including~     fluorouracil (5FU) or capecitabine, oxaliplatin and irinotecan, and patients have RAS mutant~     tumours.~   "
3577|NCT03010410|"~     Aging is associated with immunosenescence and impaired host defense mechanisms, contributing~     to influenza-related morbidity and mortality. Preliminary data demonstrate that the platelet~     transcriptome is markedly different between healthy subjects and influenza patients.~     Interferon-induced transmembrane proteins (IFITM) family members are among the transcripts~     significantly increased in platelets during influenza and expression of IFITM-3 is impaired~     in elderly subjects, a pattern associated with increased mortality. This study will build on~     these data and investigate if aging influences the expression of platelet IFITM family~     members in patients with influenza and sepsis.~      This study will prospectively determine if aging alters the induction of (IFITMs) in~     platelets from hospitalized influenza and sepsis patients. The study will also determine if~     diminished expression of IFITM family members correlates with an increased risk of adverse~     outcomes in older influenza and sepsis patients.~   "
3578|NCT03010397|"~     Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes~     (PROGRESS)~   "
3555|NCT03010709|"~     Aneurysmal subarachnoid haemorrhage (aSAH) affects up to 10,000 individuals per year in the~     UK. It accounts for ~5% of strokes, but is responsible for about 25% quality-adjusted life~     years (QALYs) lost due to stroke. Although early repair of ruptured aneurysms and aggressive~     postoperative management has improved overall outcomes, it remains a devastating disease~     with mortality approaching 50%. Survivors are left with neurological injuries that range~     from subtle cognitive deficit to disabling cerebral infarctions, less than 60% them~     returning to functional independence.~      SAH triggers a series of pathological processes resulting in neuronal damage and consequent~     neurological deficit termed early brain injury (EBI). Many of the patients who survive the~     initial bleed, deteriorate days later from delayed ischaemic neurological deficit (DIND),~     which causes poor outcome or death in up to 30% of patients with SAH. Both of these~     pathological processes are still poorly understood which limits the number of treatment~     options.~      DIND is treated with blood pressure augmentation to ensure adequate blood flow in the brain.~     In awake patients, response can be easily and accurately assessed by performing a thorough~     neurological examination. In patients whose clinical condition demands sedation, intubation~     and ventilation, assessing response to treatment using the neurological examination is~     virtually impossible. Multimodality monitoring (MM), primarily microdialysis and brain~     tissue oxygen tension with catheters inserted into the relevant parts of the brain offer~     direct assessment of both delivery and utilisation of metabolic substrates at the cellular~     level. These can be used for early detection of DIND as well as monitoring during blood~     pressure augmentation. The aim of this study is to establish and validate a clinical~     protocol for MM derived management of SAH patients, to determine optimal therapies for~     correcting abnormalities in brain metabolism and explore the relationship between MD and~     other monitoring modalities.~   "
3556|NCT03010696|"~     The purpose of this study is to investigate the differences of gut Microbiome/Metabolite~     between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis~     patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.~   "
3557|NCT03010683|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used~     in the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and~     liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon,~     promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and~     augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects~     on cardiovascular function in both diabetic patients and healthy subjects. The purpose of~     this study is to investigate in patients with T2DM without coronary artery disease (CAD),~     patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test~     (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve~     flow (CFR) after treatment with metformin or agonist GLP-1R.~   "
3558|NCT03010670|"~     Among different social cues from the environment, the eyes constitute a very salient source~     for initiating social interaction or communication. Interestingly, previous work from our~     (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two~     individuals can readily evoke an increased propensity to 'mirror' other peoples' actions.~     Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that~     mirror-motor mapping at the level of the primary motor cortex (M1), also known as~     interpersonal motor resonance (IMR), is significantly increased upon the observation of~     actions accompanied by direct eye contact, compared to the observation of actions~     accompanied by averted eye gaze.~      With the present study, the investigators aim to investigate the role of eye contact on IMR~     further, and in particular, explore whether administration of the 'prosocial' neuropeptide~     oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an~     important role in promoting prosocial behavior and the perception of socially-relevant~     stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.~   "
3559|NCT03010657|"~     This study evaluates a diet modification in adults undergoing chemotherapy for non-small~     cell lung cancer. Half of participants will modify their diet, while the other half will~     continue to eat their habitual diet.~   "
3560|NCT03010644|"~     The consequences of childhood obesity are devastating, affecting the physical and mental~     health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI~     during the summer months and there is a dearth of information regarding the causal health~     behaviors and environmental factors. The overall objective of this application is to provide~     an in depth examination of key dietary and physical activity behaviors as well as the food,~     physical activity, and social environments of low-income, racial/ethnic school-age children.~     To achieve this goal, an observational study utilizing a multi-state prospective cohort~     design will be conducted with the goal of examining the weight gain trajectory among a~     racially and ethnically diverse convenience sample of disadvantaged school-age children who~     routinely attend structured programming during the summer months and those who don't~     participate in structured programming. In addition, a subset of these children will be~     evaluated to learn their daily health behaviors, as well as their food, physical activity,~     and social environments during the summer. Identification of determinants of program~     participation and factors that may enhance the beneficial effects of program participation~     will also occur. A social ecological framework approach will guide the research. This study~     can be expected to have a significant positive impact by providing information on the~     factors that protect disadvantaged children from unhealthy weight gain during the summer~     which can be used by stakeholders at the local, state, and federal level to reform current~     policy that will increase child participation in health promoting programming during the~     summer window of risk.~   "
3561|NCT03010631|"~     A study to compare the pharmacokinetics and food-effect bioavailability of lubiprostone~     sprinkle in healthy volunteers.~   "
3562|NCT03010618|"~     In recent years restoring carious of fractured primary teeth with stainless steel crowns~     (SSC) has became more popular than ever. On the other hand the traditional operative~     approach of complete removal of caries is steadily losing support due to successful results~     with materials of high microleakage resistance.~      Treatment time and pain control in asymptomatic teeth has always been a problem in children.~     Hall technique is a minimally invasive treatment protocol that doesn't require local~     anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.~      But this protocol also raised questions in the scientific community about its possible~     effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal~     contact and increasing vertical dimension.~      The aim of our research is to study the effects of Hall technique's premature occlusal~     contact on TMJ.~   "
3893|NCT03006250|"~     The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on~     respiratory events during a less than 2-hour elective surgery.~   "
3563|NCT03010605|"~     Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal~     for return to optimum function. Traditionally, adequate range of motion has been achieved by~     a combination of in-home and outpatient physical therapy. While physical therapy is~     successful, it has the limitation of cost and availability. As copayments rise, patients may~     decide that they cannot afford physical therapy, potentially compromising the outcome of~     their surgery and successful return to function.~      It is assumed that having an easy and fun to use, patient administered, incentive device~     that provides accurate, quantitative flexion and extension measurements may accelerate~     patient mobility and return to function after TKA. The Measuring Every Day (MED) portable~     goniometer is commercially available and provides objective, consistent range of motion~     measurements that are recorded and can be sent electronically to the clinician's office~     potentially enabling earlier clinical or therapy adjustments or modifications to the~     prescribed therapy.~      Goniometry is a commonly used tool to measure and document range of motion (ROM) during~     clinical evaluation or a physical therapy examination. The technique is used to assess the~     limitations of a patient's joint and provide information to the clinician that may help~     determine further treatment.~      The study is designed to compare range of motion measurement data for 6 weeks in patients~     that have been randomized to receive either traditional physical therapy or the MED device.~     The hypothesis is that patients who use the MED device achieve equivalent range of motion at~     six weeks as compared to patients participating in traditional standard of care physical~     therapy.~   "
3564|NCT03010592|"~     Studying the airway microenvironment in patients undergoing surgical and bronchoscopic~     interventions for COPD~   "
3565|NCT03010579|"~     This is an randomized trial to evaluate the potential benefit of erythropoietin in the~     treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell~     transplantation.~   "
3566|NCT03010566|"~     Studying the microbiome of the lung in patients treated with endobronchial lung volume~     reduction coils for emphysema~   "
3567|NCT03010553|"~     Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a~     99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along~     with the other lymph nodes of the selective group II and III recess. Sentinel lymph node~     staging alone and complete dissection with routine anatomical pathology will be compared If~     this technique is reliable it will make a therapeutic de-escalation in the treatment of~     small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel~     node is free from metastasis and also to better choose the treatment in case of lymph node~     involvement~   "
3568|NCT03010540|"~     Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate~     Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone~   "
3569|NCT03010527|"~     This is a multicenter extension study to assess the long-term safety, tolerability and~     efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis~   "
3570|NCT03010514|"~     This is a national registry study to determine genetic risk factor and serial biomarkers of~     thoracic aortic aneurysm/dissection~   "
3571|NCT03010501|"~     In this study, the investigators will vary the energy density of foods served during three~     5-day periods. There will be a baseline condition, and then a condition where the energy~     density of food is lower and a condition where the energy density of food is higher. The~     primary aim is to determine the effect of varying the energy density of foods served over 5~     days on energy intake in preschool children. It is hypothesized that mean daily energy~     intake will be greater when children are served higher energy dense foods over 5 days than~     when served lower energy dense foods over the same period. Additionally, it is hypothesized~     that daily energy intake in the conditions with higher and lower energy densities will begin~     to converge across the 5-day period.~   "
3572|NCT03010488|"~     Previous data suggest some depressed patients act as if their internal biological clock is~     out of sync with the outside world and re-aligning their clock with the timing of sunlight~     lessens their depressed mood and accompanying depressive symptoms. This chronotherapy may~     produce remission during the first week of treatment while causing minimal problems. This~     study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for~     inducing sleep phase advance. Which chronotherapy condition a participant will receive will~     be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior~     to determination of which protocol a patient will follow, each patient will declare their~     desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific~     times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned~     sleep times will differ between groups using different strategies to shift the timing of~     their sleep from their ideal sleep time as determined by their MEQ score to their desired~     sleep time. All participants will be rated daily by telephone for the first week following~     randomization, and then weekly for an additional five weeks. Whenever possible, weekly~     visits will be in person, although telephone visits will be allowed. All participants will~     be rated at baseline, 1 week and 6 weeks by an Independent Evaluator blind to treatment~     assignment (as well as the nature of the treatment and if it has occurred or not). After the~     six week post-randomization evaluation, all participants will be offered six months of~     continued treatment and be rated monthly. Treatment during this six month period may consist~     of Chronotherapy or conventional antidepressants as the patient and doctor determine.~     Standard ratings of depression, over-all illness and functioning will be obtained. Change in~     the symptom measures will determine treatment efficacy. Analysis of saliva melatonin levels,~     sleep logs and activity monitor data will measure the timing of the biological clock and~     whether it has been shifted by the treatment. Measures of functioning will determine whether~     functioning improves coincident with, independent of, or subsequent to mood improvement.~   "
3573|NCT03010475|"~     This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of~     oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.~   "
3574|NCT03010449|"~     A single arm pilot study of lung volume reduction in severe emphysema using bronchoscopic~     autologous blood instillation in combination with intra-bronchial valves.~   "
3575|NCT03010436|"~     Benralizumab is a type of medicine called a monoclonal antibody that is made in the research~     clinic; it works by blocking a specific protein in the body called interleukin-5. The study~     medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. It is~     considered an experimental drug in this study.~   "
3576|NCT03010423|"~     The study is a single-center, interventional, pilot study to evaluate the improvement of~     microvascular function by positron emission tomography (PET) after twelve-week treatment of~     oral nicorandil in female non-obstructive CAD subjects.~   "
3579|NCT03010384|"~     The aim of this study was to investigate the impact of a rehabilitation program including a~     physician specialized in social medicine parallel to treatment for suspected spinal disc~     herniation.~   "
3894|NCT03006237|"~     A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001~   "
3580|NCT03010371|"~     This multicenter study aims to prove the efficacy of a pilot psychosocial evidence-based~     treatment (Positive Psychotherapy) in two formats (online vs face-to-face) with an online~     support control group. It develops as a randomized-controlled trial in a group of primary~     breast cancer survivors assigned to one of the three experimental treatments. The principal~     dependent variables assessed will be emotional distress, post-traumatic growth and QoL. Some~     treatment predictors of psychosocial response will be explored. Lastly, an economic~     analysis, comparing the three psychosocial treatments and focused on the quality adjusted~     life years (QALY) will be made. It is expected to find higher efficacy in psychosocial~     indicators and QALY for Positive Psychotherapy in the two experimental intervention formats~     than in the online support group. It is hypothesized that the face-to-face format will be~     more effective for severely distressed patients with previous history of trauma, while the~     online format will be more effective for younger patients with mild emotional distress.~   "
3581|NCT03010358|"~     This phase I/II trial studies the side effect and best dose of entospletinib when giving~     together with obinutuzumab and to see how well they work in treating patients with chronic~     lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that has come~     back. Entospletinib may stop the growth of cancer cells by blocking some of the enzymes need~     for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability~     of cancer cells to grow and spread. Giving entospletinib and obinutuzumab together may work~     better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma,~     or non-Hodgkin lymphoma.~   "
3582|NCT03010345|"~     patient receiving treatment using the osmed expander will have enough soft tissue coverage~     securing the bone graft which will be placed in a later stage to close the alveolar cleft.~   "
3583|NCT03010332|"~     This is an expanded access protocol designed to provide access of ATA230 to subjects with~     cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard~     antiviral therapy and have no comparable treatment options.~   "
3584|NCT03010319|"~     The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management~     of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care~     treatment. Half of patients will be treated using PriMatrix while the other half will~     receive Standard of Care treatment.~   "
3585|NCT03010306|"~     Building on an intervention for early child development from the SPARK Center in Boston,~     Socios En Salud (SES) pilot tested CASITA a community-based package to screen and treat~     young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in~     Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental~     delays within the clinics and community and delivered a structured early intervention that~     included parent coaching and social support. In order to test the hypothesis that CASITA~     improves early child development, caregiver, and home environment, dyads received either~     nutrition supplements alone, nutrition + CASITA early child development sessions~     individually, or CASITA in a group of 10 dyads.~   "
3586|NCT03010293|"~     Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury~     or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe~     complication with a poorly known management, and is associated with a high rate of relapse,~     leading to a high-burden in hospital bed-days, financial cost, surgical intervention,~     antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone~     and joint infection management, the medical and surgical strategies are systematically~     discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical~     strategy (debridement with initiation of vacuum-assisted closure therapy until~     reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context,~     our study aims to evaluate this complex approach and to determine risk factors of treatment~     failure in order to improve patient management, focusing on optimization of empirical~     antimicrobial therapy after each surgical stage, delay between the two surgical stage, and~     duration of antimicrobial therapy.~   "
3587|NCT03010280|"~     A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric~     bypass will be performed. Patients will be randomly assigned into 2 groups: those patients~     receiving a preoperative balanced energy high-protein formula (group 1) and those receiving~     preoperative Immunonutrition (group 2). Preoperative weight loss, postoperative septic~     complications and analytical acute phase reactants will be investigated.~   "
3588|NCT03010267|"~     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics~     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each~     component administered alone in healthy male volunteers.~   "
3589|NCT03009214|"~     This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation~     study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose~     (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will~     be determined after completion of Part 1 considering safety and tolerability, also beyond~     the dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD)~     results.~   "
3590|NCT03009201|"~     This phase Ib trial studies the side effects and best dose of ribociclib when giving~     together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that~     has spread to other places or that cannot be removed by surgery. Ribociclib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in~     treating patients with soft tissue sarcoma.~   "
3591|NCT03009188|"~     Axenfeld-Rieger syndrome (ARS) is a rare autosomal dominant disorder, characterized by~     anterior segment abnormalities and systemic abnormalities. To date,two major genes, forkhead~     box C1 (FOXC1) on chromosome 6p25 and pituitary homeobox 2 (PITX2) on chromosome 4q25, have~     been demonstrated to cause ARS. In this study, we performed complete ophthalmologic~     examinations and analysis of FOXC1 and PITX2 of a Chinese family with ARS.~   "
3592|NCT03009175|"~     The purpose of the study is:~        -  To evaluate the Heart Failure Risk Status (HFRS) feature performance.~        -  To establish the feasibility of remote follow-up in which patient risk triaging is~          performed by nurse-led review of HFRS feature as supplemental information.~   "
3593|NCT03009162|"~     This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose~     study.~      This study will enroll up to 32 subjects using an adaptive design that can include up to 3~     groups of 8 subjects with different degree of renal impairment and one group of 8 control~     subjects with normal renal function.~      Screening data will be reviewed to determine subject eligibility. Subjects who meet all~     inclusion criteria and none of the exclusion criteria will be entered in the study.~      First, approximately 16 subjects will be enrolled with severe renal impairment and matched~     subjects with normal renal function. There will be 8 subjects in each of the following~     groups based on renal function at screening:~        -  Group 1: Healthy subjects with normal renal function (eGFR ≥ 90 mL/min/1.73m2)~        -  Group 2: Severe renal impairment subjects (eGFR < 30 mL/min/1.73m2) Based on safety and~          pharmacokinetic (PK) results from subjects with severe renal impairment (Group 2),~          Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be~          enrolled if substantial change in the exposure of lasmiditan is observed in subjects~          with severe renal impairment.~   "
3594|NCT03009149|"~     H1 - Aerobic exercise will expect to experience significant increase on CD4 counts , reduced~     viral load , improve psycho-social well being among people living with HIV /AIDS.~   "
3595|NCT03009136|"~     The aim of this study is to investigate the short and long term efficacy and the safety of~     SCRT treatment for PAR~   "
3596|NCT03009123|"~     The rationale for investigating the hypothesis that there is an association between erectile~     dysfunction (ED) and the subsequent development of prostate cancer is based on three~     assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in~     men with prostate cancer; 2) the development of ED and prostate cancer may have certain~     shared common risk factors; and 3) the use of testosterone for the treatment of ED has been~     suspected to be associated with prostate cancer development. Controversy exists over whether~     men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated~     the risk of developing prostate cancer for men with ED. The investigators, therefore,~     conducted a population-based longitudinal study with eight years' follow-up to examine this~     association and to evaluate the magnitude of the risk.~   "
3597|NCT03009110|"~     The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large~     pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness,~     safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a~     closed, sealed system that applies negative pressure to the wound surface via a single-use,~     battery-powered, portable device - to decrease surgical site infections (SSIs) in obese~     women.~   "
3598|NCT03009097|"~     Periodontitis is a major oral health problem which leads to the progressive destruction of~     periodontal ligament and alveolar bone with pocket formation, recession or both. The~     ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most~     common form of regenerative periodontal therapy is the use of bone grafts which stimulate~     bone formation by the processes of osteoinduction and osteoconduction.~      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of~     the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of~     BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti~     oxidant properties.~      Very few studies exist evaluating the beneficiary effects of grafts if combined with the~     statins which might enhance the regeneration by bone grafts.~      Hence, the present study was carried out in an attempt to comparatively evaluate clinically~     and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the~     treatment of intrabony defects.~   "
3599|NCT03009084|"~     The purpose of this study is to investigate the communication and data sharing between the~     primary care physician and the nephrologist about patients with chronic kidney disease. Also~     therapeutic interventions that change behavior and telemonitoring of the blood pressure will~     be explored and compared to the usual care. The most important aim of this study is to~     improve the quality of care for the patient with chronic kidney disease in cooperation with~     the primary care physician and the nephrologist.~   "
3600|NCT03009071|"~     A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical~     effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture~     for chronic neck pain patients compared to acupuncture alone.~   "
3601|NCT03009058|"~     During this open label study patients will receive IMM-101 in conjunction with a recognised~     standard of care for metastatic or unresectable cancer for the patient's specific tumour~     type.~      The primary objective of the study is to provide safety data for IMM-101 in combination with~     a number of selected standard of care regimens.~   "
3602|NCT03010241|"~     Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2~     diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases~     the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than~     60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have~     some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We~     postulate that patients with DSPN will benefit from therapy with TCM treatment according to~     syndrome differentiation.~      Methods and design: A randomized, double-blind, placebo-controlled and multi-centric~     clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met~     the inclusion criteria were randomly divided into two groups. The patients in the study~     group were treated with Tangbi prescription, and the patients in the control group were~     treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188~     cases.Major evaluation indicators: Changes in Clinical Symptoms and Signs in Distal~     Symmetrical Polyneuropathy patients.The clinical symptoms and signs of patients were~     recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic~     Neuropathy Score(MDNS) were compared between the two groups before and after medication.~     Secondary Evaluation Indicators:① nerve conduction velocity changes, The changes in nerve~     conduction velocity of each nerve were compared before and after taking medicine.② Clinical~     symptoms and signs change, The clinical symptoms and signs of the patients were compared~     before and after taking the medicine.~      Discussion: We postulate that patients with DSPN will benefit from therapy with TCM~     treatment.~   "
3699|NCT03008798|"~     Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal~     medicine C117--PRISIT Trial~   "
3603|NCT03010228|"~     Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy~     adults below 40 years of age.~      180 subjects will be enrolled in 6 treatment groups (different doses; different formulation:~     with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid~     region on Days 0, 28 and 56. Study participants will be followed up until one year after~     first vaccination.~   "
3604|NCT03010215|"~     Despite the development of the control of DM and the great interest for the complications of~     the disease, even today the diabetic foot represents a challenge for the orthopaedic~     surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery~     treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve~     this pathologic case.~      The purpose of this longitudinal cross-sectional study was to evaluate radiographic and~     surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis~     of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic~     through MIS.~   "
3605|NCT03010202|"~     This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance~     therapy may prolong the the effect of Rituximab in immune thrombocytopenia.~   "
3606|NCT03010189|"~     Cluster headache is one of the most painful headaches, characterized by recurring episodes~     of unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be~     of both sympathetic and parasympathetic origin. The pathophysiology behind the condition is~     largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal~     role. The headache attacks come in clusters or bouts (hence the name) which last up to three~     months, after which the headache disappears for at least one month. 10-15% have chronic~     cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and~     parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during~     remission phase. There is an emerging hypothesis that headache attacks are elicited in a~     state of autonomic hypoarousability, which is also supported by the fact that most cluster~     attacks occur during the night, when the patients are sleeping.~      The aim in this project is to study the intercept between the sleep-wake cycle, autonomic~     tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and~     pupillometry. All these methods are well validated, and frequently used in studies on sleep~     and autonomic function. The study design is that of a case-control model where 15 cluster~     headache patients will undergo pupillometry, before wearing the actigraph and heart-rate~     variability-monitor for two weeks, once in cluster bout and once in remission phase. The~     actigraphy will register nocturnal movement and sleep quality, and headache attacks will be~     registered by pressing a button on the actigraph. The pupillometry measures pupillary~     constriction and dilation in response to light, a reflex that is controlled by the autonomic~     nervous system. The heart-rate variability monitors fluctuations in the heart rate which~     reflects the sympathovagal balance of cardiac control. All participants will fill out the~     Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy~     controls will undergo one session of the same examinations. The results of the study will~     give valuable insight to the pathophysiology of a condition that is very painful and has~     great impact on the patients' quality of life, and also add knowledge to the relation~     between headache, sleep and the autonomic nervous system.~   "
3607|NCT03010176|"~     The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum~     administered dose (MAD) of MK-1454 alone or MK-1454 in combination with pembrolizumab~     (MK-3475) in participants with advanced/metastatic solid tumors or lymphomas. MK-1454 will~     be administered intratumorally (IT); pembrolizumab will be administered intravenously (IV).~   "
3608|NCT03010163|"~     This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC~     taxi garage bases and airport taxi holding lots and pedometers. Group 2 includes Health~     Fairs, pedometers and text messaging to facilitate walking and living a healthier lifestyle.~     Group 3 includes Health Fairs, pedometers and social network support. Group 4 includes~     Health Fairs, pedometers, text messaging and social network support.~   "
3609|NCT03010150|"~     Head and neck cancer patients who receive radiation therapy are at risk for permanent~     swallowing disorders and problems with their teeth. Because of these potential problems,~     swallowing exercises and good dental habits are an important part of recovery.~      The goal of this clinical research study is to learn about the reasons head and neck cancer~     patients may or may not follow the swallowing exercises that they are asked to perform after~     receiving radiation treatments. Researchers also want to learn if certain levels of~     cytokines affect if participant has side effects and if it puts participant at risk for~     future disease. Cytokines are proteins that are related to the immune system.~   "
3610|NCT03010137|"~     Incisional negative pressure therapy (INPWT) has previously been shown in certain patient~     populations to decrease wound healing complications, decrease the rate of hematomas and~     seromas, as well as have better scar quality. We have found a group of patients, those who~     have panniculectomies in preparation for renal transplant, with significantly higher rates~     of wound healing complications. We believe the best way to demonstrate benefits of~     incisional negative pressure wound therapy will be in this group of patients known to have~     significantly higher rates of wound complications.~   "
3611|NCT03010124|"~     The investigators therefore propose to conduct a biological study of prospectively collected~     patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical~     smear) throughout the disease course where markers (at diagnosis and their change with~     treatment) will be correlated to outcome in order to investigate how genetic diversity in OC~     prior to treatment and adaptation following treatment contribute to chemotherapy resistance.~     In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex~     vivo DNA repair functional assays and isolated in primary culture (and established as~     xenografts) for target validation experiments.~   "
3612|NCT03010111|"~     The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using~     whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean~     health care workers.~   "
3613|NCT03010098|"~     To investigate the effect on older's cognition of the application of closed~     target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .~   "
3614|NCT03010085|"~     Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional,~     prospective and randomized trial in patients undergoing left sided hepatectomy through~     laparoscopic versus open procedure.~      Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood~     loss, operation time, resection margin status, postoperative complication, mortality, liver~     function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness~   "
3615|NCT03010072|"~     This is a single-center, prospective, open-label, controlled, randomized, cross-over study~     in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with~     hyperphosphatemia.~   "
3700|NCT03008785|"~     This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have~     greater effects on climacteric symptoms than exercise alone in postmenopausal women. the~     participants will be randomly assigned to the group: placebo and exercise or 100mg of~     isoflavone and exercise.~   "
3616|NCT03010059|"~     The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by~     measuring ALS-008112 plasma concentrations following administration of a single oral dose of~     JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to~     their respective current formulations under fasted conditions and to assess the effect of~     food on the pharmacokinetics of the 2 new concept formulations under fed condition in~     healthy adult participants.~   "
3617|NCT03010046|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending,~     single-infusion, sequential group study. Single, ascending doses will be administered to~     approximately 56 subjects, with an option for 1 additional multi-dose cohort in~     approximately 8 subjects. The primary objective is to evaluate the safety of ANX005~     administered as an intravenous infusion as a single agent and in combination with~     intravenous immunoglobulin (IVIg). The optional multi-dose cohort will evaluate either~     additional subjects at the maximum tolerated dose or ANX005 administered as 2 infusions.~   "
3618|NCT03010033|"~     It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative~     complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary~     rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the~     effect and long-term results of pulmonary rehabilitation on smoker patients have not been~     studied. The purpose of this study is to determine whether pulmonary rehabilitation is~     effective to smoker patients who underwent lobectomy.~   "
3619|NCT03010020|"~     The investigators propose to develop and pilot an HIV prevention intervention based on~     rectal STI testing, counseling, and treatment for MSM in Peru. The investigators will use~     nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or~     chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic~     treatment and single-session Personal Cognitive Counseling (PCC) (n=50) or standard~     post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to~     compare biological outcomes including changes in levels of inflammatory cytokines following~     rectal STI. The intervention is based on three interrelated objectives: 1) To use periodic~     rectal STI nucleic acid testing to identify the members of the MSM population at greatest~     short-term risk for HIV infection; 2) To provide single-dose antibiotic treatment to control~     the immune activation and mucosal inflammation caused by rectal GC/CT infection that~     increase cellular risk for HIV transmission; and 3) To use Personal Cognitive Counseling~     (PCC) to understand and modify recent high-risk sexual practices that led to rectal STI~     acquisition and that increase future HIV risk.~      The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT~     infection to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence~     estimate) and 50 GC/CT-negative controls (matched by age and baseline frequency of URAI).~     GC/CT-infected participants will be given single-dose antibiotic therapy and randomized to~     receive single-session PCC (n=50) or standard post-test counseling (n=50). The primary~     outcome will be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary~     outcomes will assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact~     of GC/CT infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand~     IL-1β) in rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV~     incidence in GC/CT-infected and -uninfected MSM.~   "
3620|NCT03010007|"~     Influenza associated illness has a global annual impact with high morbidity and mortality.~     Transmission mechanisms and rates are under-investigated and overall poorly understood.~      This project aims to use epidemiological tools to understand the transmission and evolution~     of influenza viruses at an individual and population level within a small-scale city (Basel)~     through a combination of experimental, clinical and mathematical advances. The investigators~     aim to quantitatively characterize the viral transmission using novel~     molecular-epidemiological tools based on whole genome sequencing.~   "
3621|NCT03009994|"~     Cesarean section is one of the most frequently performed major operations worldwide. It~     accounts for between 1% and 70% of deliveries depending on the facilities or country~     assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private~     hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut~     university is 51.3% of all deliveries.~      Different Operational techniques For cesarean section have been defined aimed at reducing~     surgical time, making the surgery easier and more efficient, lowering costs,decreasing the~     risk of adverse effects and postoperative morbidity, as well as length of hospital stay.~      Also, Intraoperative blood loss is one of important complications during cesarean section. A~     systematic review included twenty one studies, in 2011, revealed that increase incidence of~     intraoperative blood loss and blood transfusion with increase number of cesarean~     deliveries.also anemia in the pregnancy increase maternal morbidities included~     intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant~     women about 51% of pregnant women.~      After baby born by cesarean section and the placenta has been extracted, uterine incision is~     sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization~     of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal~     cavity (in situ repair). There had been few randomized controlled trials comparing~     intraoperative and postoperative morbidity following exteriorization of the uterus with~     non-exteriorization. The conclusions drawn from these trials have been conflicting.~   "
3622|NCT03009981|"~     This is a randomized, open-label, three-arm, phase 3 study in men with biochemically~     recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.~   "
3623|NCT03009968|"~     After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients~     requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with~     acute retention experience urinary tract infections in the postoperative period (6, 7). Many~     women consider being discharged with a Foley catheter to be a surgical complication and~     describe catheter use as the worst aspect of their surgery(8). At this time there is no~     consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on~     how to best assess voiding function postoperatively. FPMRS providers both within the United~     States and around the world utilize a variety of void trial methods and varying criteria to~     determine adequacy of post-operative voiding efficiency (5).~      The traditional backfill assisted void trial method involves the assessment of a postvoid~     residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,~     there have been efforts to determine ways to avoid the assessment of a PVR as it is~     time-consuming and potentially exposes the patient to additional catheterizations (9, 10).~     Many FPMRS providers utilize the backfill assisted method without assessing a PVR and~     instead utilize a certain voided volume threshold to determine adequate voiding. However, to~     date, no one has directly studied this approach or compared the traditional backfill~     assisted void trial to a PVR-free backfill assisted void trial. By decreasing~     catheterization and creating a more efficient void trial method, the investigators hope~     improve patients' postoperative experience and reduce catheterization and risk of urinary~     tract infection (UTI).~      This study aims to compare two void trial methodologies in order to help standardize~     post-operative care in the urogynecology population. This study also has potential to lead~     to an overall change in our field and improve the postoperative course for women across the~     country and abroad.~   "
3624|NCT03009955|"~     To everyone knows, more and more patients received repeated caesarean section in China.~     However, at present it is not known what is it like about their postoperative pain~     intensity, and is it different from those patients who received primary caesarean section.~     Thus through postoperative follow-up, the current study aimed to investigate and compare the~     postoperative pain between patients received primary and repeated caesarean section.~   "
3625|NCT03009942|"~     This study evaluates the nitric oxide and arginase levels in patients with dental implants.~     Peri-implant sulcular fluid and saliva samples were collected after loading of the implants~   "
3626|NCT03009929|"~     Whereas there are several validated systems for reporting postoperative complications, there~     are only a few and not prospectively validated systems for reporting intraoperative~     complications. The investigators developed a definition and CLASSification for~     Intraoperative Complications CLASSIC within a Delphi study involving international~     interdisciplinary experts. As both surgery and anaesthesia may be involved in complications~     in the perioperative period, all patient-related intraoperative complications occurring~     between skin incision and closure are considered in this reporting system.~      The aim of this international multicentre observational cohort study is to assess the~     validity and practicability of this newly derived classification system CLASSIC in patient~     undergoing an in-hospital surgical procedure. Providing an easy applicable and~     internationally validated classification system is a contribution to improve quality of~     health care and patient safety.~   "
3627|NCT03009916|"~     The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion~     and glucose homeostasis, both with and without bile acid sequestration.~   "
3628|NCT03009903|"~     This multi-center, outpatient study will extract and evaluate the presence of facial P.~     acnes bacteria and phage strains using pore strips on up to 400 human subjects.~   "
3629|NCT03009890|"~     Objective: to compare the functional outcome after open reduction and internal fixation with~     non-operative cast treatment for elderly patients with displaced intra-articular distal~     radius fractures.~   "
3630|NCT03009877|"~     Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient~     population. This study will examine whether Optiflow can do this, and compare the~     pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.~   "
3631|NCT03009864|"~     This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2~     diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to~     evaluate the therapeutic effect of tang shen prescription. 632 participants will be~     recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is~     normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to~     treatment with either tang shen prescription or placebo.~   "
3632|NCT03009851|"~     The goals of the proposed research were to:~        1. describe the person and environment characteristics and activity patterns of residents~          in long-term care (LTC) facilities;~        2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI)~          grounded on the results of Aim 1;~        3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation~          into LTC facilities relative to a usual activities group;~        4. determine the cost-effectiveness of the intervention conducted by in-house staff~          compared to the control group; and~        5. examine person and environment factors as potential moderators of the relationship~          between treatment condition and adaptation outcomes.~   "
3633|NCT03009838|"~     Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate~     is the most commonly used oral agent for ovulation induction in this group, but there are~     some drawbacks with the use of it.~   "
3634|NCT03009825|"~     The purpose of this study is to investigate the associations between lifetime exposure to~     traumatic events, emotion regulation strategies, and eating pathology of patients with~     obesity.~   "
3635|NCT03009812|"~     The Aim of the study is to compare between transverse and longitudinal uterine incision in~     abdominal myomectomy regarding intraoperative blood loss.~   "
3636|NCT03009799|"~     This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in~     decreasing the number of days where adenoviral conjunctivis is detected in the eye and in~     reducing the duration and/or the severity of the signs and symptoms of adenoviral~     conjunctivis~   "
3637|NCT03009786|"~     The main objective of this study is to achieve cross-cultural and psychometric validation of~     the Xerostomia Inventory initially developed in English language into French Language. This~     will be achieved in two stages: First, cross-cultural validation, and a second, psychometric~     validation The cross-cultural validation will be performed according to the methodology of~     the Institute for Work and Health, according to the recommended six phases. In a second~     step, the psychometric validation will be done using longitudinal study. Indeed, an~     observational, longitudinal, and prospective study will be set up. Analysis of the results~     will help define the feasibility and acceptability of the tool, its validity (content~     validity, perceived validity, construct validity, concurrent validity, and discriminant~     validity), its reliability (internal consistency and reproducibility over time).~     Longitudinal follow-up of patients is expected to also assess the predictive validity and~     responsiveness.~   "
3638|NCT03009773|"~     Stroke is the leading cause of severe disability in adults. The first cause of alterations~     in the quality of life and autonomy in these patients are disorders of walking and the~     balance. They are the leading cause of falls responsible for important medical, surgical and~     economic complications as well as a reactionary social isolation.~      The techniques of rehabilitation of walking to the subacute phase of a stroke are usually~     based on automatic walking.Off walking is a complex activity usually performed in everyday~     life in association with multiple tasks. It is therefore interesting to re-educate walking~     in dual task or even in multitasking.~   "
3639|NCT03009760|"~     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of~     CJ-12420 after single and multiple dose administration according to H. pylori infection.~   "
3640|NCT03009747|"~     This research plans to collect rectal cancer patients after sphincter-preserving surgery~     from 14 institutions in China mainland, observe the incidence and risk factors about bowel~     dysfunction after operation.~   "
3641|NCT03009734|"~     AntibioTx is developping ATx201 as a topical product for treatment of skin infections,~     including infected atopic dermatitis.~   "
3642|NCT03009721|"~     The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in~     patients with essential hypertension and dyslipidemia~   "
3701|NCT03008772|"~     To define the long-term incidence and frequency of ISR follow DES implantation. Compare the~     clinical presentation, treatment and intervention success among de novo coronary artery~     stenosis and DES ISR.~      Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,~     assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,~     6 months, 1 year, 3 years, and 5 years, if available.~   "
3643|NCT03009708|"~     Traditionally known for their role in haemostasis, platelets have also an immune role.~      Platelets play a key role in immune mediator secretion, and interact with innate and~     adaptive immune cells, contributing to the fight against pathogens, as viruses.~      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of~     the induced immune depression. Platelets activation for patients is not determined during~     the post-graft period, and platelet induced inflammation following a CMV infection is not~     described.~   "
3644|NCT03009695|"~     Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term~     effective drug treatment was developed for obesity. Lyfe style modulation and bariatric~     surgery are the only interventions with a limited rate of success. Obesity is due to several~     factors, mainly linked to a neurophysiological mechanism of food addiction. The use of~     repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and~     food craving in obese subjects, leading eventually to a weight reduction. dTMS was already~     tested successfully in other forms of addiction (smoking, alcohol, cocaine) and the~     usefulness of dTMS in the treatment of food addiction, and therefore in obesity, was~     hypothesized. End-points of this research will be: 1) effect on food craving; 2) acute and~     chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic~     effects on body weight. The demonstration that a safe, non-invasive and repeatable~     methodology can treat obesity reducing food craving and modulating appetite/satiety hormones~     secretion will constitute a cornerstone in translational medicine of metabolic diseases.~   "
3645|NCT03009682|"~     This study is a single arm, multi-center phase II study of olaparib monotherapy in patients~     with relapsed small cell lung cancer (SCLC) harboring BRCA 1/2 mutations, ATM deficiency or~     MRE11A mutations as second or third line chemotherapy.~      Target subject population:~      Patients with small cell lung cancer that have progressed following first-line~     platinum-based therapy. Patients must have imaging confirmed progression on 1st line~     chemotherapy for SCLC treatment, which must have contained platinum-based regimen, with at~     least one measurable lesion per RECIST 1.1.~   "
3646|NCT03009669|"~     To assess the value of using pleth variability index(PVI) to monitor the patient's~     intra-operative volume status continuously by observing the application of stroke volume~     variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor~     surgeries.~   "
3647|NCT03009656|"~     The emergency setting for acute neurological conditions, such as stroke, is peculiar due to~     time pressure and limited resources for further diagnostics. Clinical skills are essential~     for swift and accurate bedside diagnosis and thus are the basis for early and correct~     treatment. This is especially evident in the context of computed tomography being the~     standard neuroimaging method world-wide with its limitations for detecting smaller infarcts,~     strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic~     seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by~     neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not~     been studied in detail. In order to improve clinical diagnosing and future treatment it is~     essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting~     (how good are neurologists?) and to assesses whether there are any differences between~     experienced staff neurologists and junior physicians.~   "
3648|NCT03009643|"~     Hypoxemia is a common complication after aortic surgery. As this complication has an adverse~     effect on the postoperative course of the patient, early treatment is important; however,~     the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear.~     Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in~     some of these patients. The investigators are trying to evaluate the effectiveness and~     safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.~   "
3649|NCT03009630|"~     The objective of the study was to evaluate the efficacy and safety of electromagnetic~     navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of~     early-stage peripheral lung cancer.~   "
3650|NCT03009617|"~     Through the training and consultation program conducted via the web for health promotion,~     which is an important part of a school's healthcare, interactive communication methods~     between school nurses and students were provided. The results of the study showed that~     web-based education and counseling positively influenced health promotion behaviors of the~     students, and e-health literacy and their knowledge was increased.~   "
3651|NCT03009604|"~     Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which~     thereby decreases the total colony count of bacteria, thus, decreasing peritoneal~     contamination in case of bowel injury, improving the access to the surgical field and~     facilitating intraoperative bowel manipulation~   "
3652|NCT03009591|"~     Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds,~     especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain~     joints, causing a progressive joint deterioration. Secondary disorders to this joint~     degeneration include: biomechanical alterations, loss of range of movement and periarticular~     muscle atrophy.~      Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of~     a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of~     the elbow.~      Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy~     in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with~     hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients~     will be recruited in 6 centers, from different regions of Spain.~      Intervention: Each session will last approximately 50 minutes, with three physiotherapy~     sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers~     that must be administered bilaterally:~      Measuring instruments and study variables: goniometric evaluation (range of movement);~     visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH~     Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of~     life). At the same time, the study will allow to determine joint bleeding caused by applied~     physiotherapy treatment.~      Expected results: First, it is intended to demonstrate the safety of this physiotherapy~     technique in patients with hemophilia. Likewise, an improvement in the perception of elbow~     pain and joint mobility is expected. An improved functionality of the upper limb is also~     foreseen and with it, an enhanced perception of quality of life of these patients.~   "
3653|NCT03009578|"~     Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive~     ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated~     pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care~     programmes in numerous developing and underdeveloped nations.~      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum~     period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due~     to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies~     and postpartum hemorrhage are important causes of postpartum anemia~   "
3654|NCT03009565|"~     Background: The human gastrointestinal system is populated with a variety of symbiotic~     microorganisms, namely microbiota. The microbiome is the total genetic data of the~     microbiota. The human gut microbiota interacts extensively with the host through metabolic~     exchange; thereby contribute to a variety of metabolic and immunologic mechanisms in the~     human body. Coronary artery disease (CAD) is major cause of morbidity and mortality~     worldwide and is a major field of interest in microbiota research. There have been several~     findings that connect the gut microbiota to CAD pathophysiology, but these data relates~     solely to the interaction between human gut microbiome and cardiovascular risk factors. As~     far as known , data regarding patients who already developed CAD is lacking.~      Aims: To investigate gut microbiota of patients with CAD, thereby allowing the adjustment of~     personalized treatment by changing the pro-atherosclerotic environment in the gut.~      Methods: Study participants will include patients arriving to Rabin Medical Center with~     suspected CAD. Patients will provide medical, lifestyle, and nutritional questionnaires.~     Vital signs measurements will be taken as well as fecal samples and/or rectal swabs. Blood~     samples will be drawn to measure blood chemistry including lipid profile and~     trimethylamine-N-oxide (TMAO) levels. Patients will undergo cardiac CT and/or cardiac~     catheterization in accordance with the decision of the cardiologist to evaluate and/or treat~     CAD. Genomic DNA will be extracted from stool samples for Microbiome analysis.~      Innovation: The hypothesis is that there is a unique microbiota pattern in patients with~     coronary atherosclerosis, which may contribute to the pathogenesis and/or expression of CAD.~     Knowing the unique microbiota in patients with coronary disease, would render it as novel~     target for treatment, either primary or secondary prevention.~      Collaboration: Between Cardiology department at Rabin Medical Center and the lab of Prof.~     Eran Segal located at the Weizmann Institute of Science. The collaboration between these two~     groups will combine the clinical expertise of treating cardiac patients with novel~     scientific technology and concept.~   "
3655|NCT03009552|"~     The overall objective of the study is to determine whether speckle tracking echocardiography~     presents additional prognostic value to the routine assessment (clinical and~     echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the~     emergency department. Specific objectives: 1 - To evaluate the association between changes~     in the cardiac contractile mechanics (by serial measurements of strain, strain rate,~     displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 -~     Evaluate the possible association of these parameters with biomarkers of neurohormonal~     activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and~     cardiorenal syndrome.~   "
3656|NCT03009539|"~     The purpose of this study is to test the relative effectiveness of a Hispanic-specific~     eHealth intervention, e-Health Familias Unidas, in preventing and reducing drug use,~     sexual risk behaviors, and STIs among Hispanic youth in primary care. Families will be~     recruited through four pediatric primary care settings. Pediatric staff and research team~     members, including nurse assistants and mental health professionals, will implement eHealth~     Familias Unidas.~   "
3657|NCT03009526|"~     This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine~     if IPTp-DP is associated with a reduction in malaria infection at delivery among~     HIV-negative women in an area with high levels of SP resistance in Malawi.~   "
3658|NCT03009513|"~     An open label, one sequence study to investigate the pharmacokinetic drug interaction~     between Teneligliptin and Glimepiride in healthy male subjects~   "
3659|NCT03009500|"~     The purpose of this study is to evaluate three different injectable solutions used to block~     ankle nerves to manage ankle pain. The current standard of medical care is to inject a~     combination of local anesthetics and steroids around injured nerves. There is evidence that~     injection of local anesthetic (without the steroid) can calm the injured nerve and provide~     pain relief from a few days up to a few months. Injection of sterile salt water also has the~     potential to provide pain relief by breaking scar tissue around the nerve thereby relieving~     compression. Injections of local anesthetic and steroids around injured nerves have been~     used for many years to provide relief of pain but the specific reason is not well known for~     this benefit.~      There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2)~     local anesthetics can have similar actions but with shorter duration (few days), and 3)~     injection of any solution can break scarring around an injured/compressed nerve.~      The study will compare pain relief and possible adverse effects from these three different~     solutions. This study will help provide definitive answers regarding pain relief and~     possible adverse effects of the three solutions. This, in turn, will determine the best~     possible option for injection in patients with nerve-related injury pain.~   "
3660|NCT03009487|"~     A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy~     and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with~     concomitant hypertension and hyperlipidemia~   "
3661|NCT03009474|"~     To compare the pharmacokinetics and safety after a single dose administration of CJ-30060~     and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.~   "
3662|NCT03009461|"~     According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib~     is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),~     but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not~     benefit much from sorafenib in previous studies. There is no established standard treatment~     for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to~     investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy~     (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with~     Major Portal Vein Tumor Thrombosis.~   "
3663|NCT03009448|"~     Analysis of recent studies show that researchers find it hard to distinguish between Late~     Onset Depression, a first diagnosed major depressive episode which occurs at old age, and~     Early Onset Depression, a depressive episode at old age with a history of previous episodes.~     Since current data, about the phenomenology and etiology of Late Onset Depression, lake~     conicity it is unclear whether this phenomena should be considered as a distinct subtype of~     depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a~     stronger correlation with brain damage and environmental risk factors such as the common~     losses at old age and weaker correlation with family history and genetics when compared to~     Early Onset. Although many researchers consider brain damage to have the main contribution~     to the emerge of Late Onset Depression, the fact that depression has a negative effect on~     one's health supports the claim that it might be the result and not the rick factor. Since~     Late Onset Depression correlates with the common losses at old age, the investigators~     propose that an existential approach that deals with one's meaning, freedom, responsibly and~     death, might be more appropriate. Thus, the investigators ask how do older adults experience~     depression which they face for the first time in old age? Current study will seek to~     understand older adults' experience of Late Onset depression through existential paradigm by~     using a semi constructed interview.~   "
3664|NCT03009435|"~     Introduction:~      The frequency of fetuses in occiput posterior position during labor is approximately 20 %,~     in which 5% remain occiput posterior at the end of labor. Occiput posterior position is~     associated with higher risks of caesarean deliveries and operative vaginal deliveries. The~     manual rotation to promote rotation from a posterior to an anterior position has been~     proposed to reduce the extraction rate. There is no randomised trial comparing the effect of~     manual rotation and expectant management. We propose a protocol for a prospective,~     monocentric, randomised controlled clinical trial in order to show that the rate of~     spontaneous vaginal delivery is higher with manual rotation of occiput posterior position~     than with an expectative management.~      Methods:~      Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position~     suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible.~     Participants will be randomised to either prophylactic manual rotation (experimental group)~     or expectative management (control group). Based on an alpha value of 0.05 and gaining 20%~     for spontaneous vaginal delivery, 238 participants will need to be enrolled.~      The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be~     operative delivery rate (caesarean section , vacuum or forceps deliveries), significant~     maternal and perinatal mortality/morbidity.~      Analysis will be by intention-to-treat averaging a 24-month period.~   "
3665|NCT03009422|"~     The investigators will compare the common treatment for cutaneous leishmaniasis with~     intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.~      Outcome will be final scar appearance assesd by two dermatologist and pain measurement by~     VAS.~   "
3666|NCT03009409|"~     Closed-loop control of anesthesia involves using feedback from a measure of clinical effect~     to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a~     variable rate that is frequently personalized to each individual patient. The aim is to~     provide greater stability at an optimal depth of anesthesia, reducing the occurrence of~     under- or overdosing, with the goal of ultimately improving patient outcomes.~      The purpose of this randomized, controlled equivalence trial is to compare controller~     performance during closed-loop controlled induction and maintenance of total intravenous~     anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine~     versus saline control.~   "
3667|NCT03009396|"~     An open label extension to the RHB-104-01 Study.~   "
3668|NCT03009383|"~     The purpose of this study is to determine whether a bedside portable endoscopy is effective~     in identifying the esophageal foreign body in the emergency room.~   "
3669|NCT03009370|"~     The purpose of this study is to determine whether ovarian reserve is related to recurrent~     pregnancy loss~   "
3670|NCT03009357|"~     The study is a single-center prospective cohort study of clinical application of~     continuously monitored data by wearable activity trackers in the patients with~     thyrotoxicosis. The purpose of the study is to evaluate the association between parameters~     of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status~     along with the treatment.~   "
3671|NCT03009344|"~     This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability,~     safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in~     participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).~   "
3672|NCT03009331|"~     The study comprises two different objectives. Longitudinal description of postoperative~     pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two~     different lungrecruitment strategies.~   "
3673|NCT03009318|"~     MRS and 11C-MET PET/CT are commonly used as supplementary imaging techniques for the~     differential diagnosis of non-enhancing supratentorial gliomas. However, both techniques~     have limitations leading to misdiagnosis; therefore, the investigators attempted to combine~     these two metabolic imaging tools to evaluate whether the combination of MRS and 11C-MET~     PET/CT can increase the sensitivity of the radiological diagnosis of non-enhancing~     supratentorial gliomas.~   "
3674|NCT03009305|"~     The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).~        1. If and how changes in cerebral oxygen saturation (StO2) measured by near infrared~          spectroscopy (NIRS) relate to changes in blood flow in the carotid arteries during~          progressive LBNP.~        2. If and how mean systemic filling pressure (MSFP) can be measured by brief occlusion of~          blood flow to an arm and if this relates to LBNP-level.~        3. If and how pulse pressure variations and photoplethysmographic amplitude variations~          during positive expiratory pressure (PEP) and continuous positive airway pressure~          (CPAP) relate to LBNP-level.~   "
3675|NCT03009292|"~     Study E7080-C086-108 is an open-label, single- and multiple-dose pharmacokinetic (PK) study~     of lenvatinib (administered orally, once a day [QD]) in Chinese participants with solid~     tumor. A total of 12 participants will be enrolled to evaluate the PK of 24 milligrams (mg)~     QD dosing of lenvatinib.~   "
3676|NCT03009279|"~     To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).~   "
3677|NCT03009266|"~     The overall aim of this study is to determine whether non-invasive imaging with myocardial~     contrast echocardiography using can provide information on the presence and spatial extent~     of recent myocardial ischemia by non-invasive echocardiographic imaging.~   "
3678|NCT03009253|"~     The purpose of this study is to find the best neoadjuvant therapy for pancreatic~     adenocarcinoma.~   "
3679|NCT03009240|"~     This phase I trial studies the side effects and best dose of pevonedistat when given~     together with decitabine in treating patients with high risk acute myeloid leukemia.~     Pevonedistat and decitabine may stop the growth of cancer cells by blocking some of the~     enzymes need for cell growth.~   "
3680|NCT03009227|"~     The purpose of this study is to determine wether D3 lymph node dissection gives superior~     oncological outcomes compared to standard D2 lymph node dissection in colon cancer~   "
3681|NCT03009045|"~     The problem of interest is that doctors are looking for new antibiotic treatments for bone~     and joint infections. Treatment for bone and joint infection is not standardized, which~     allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called~     S. aureus is the most common cause of bone and joint infection. Methicillin resistant S.~     aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is~     increasingly common in U.S. and non-U.S. medical centers. This problem will be studied by~     investigating whether an antibiotic called tedizolid is tolerable, safe and effective to~     treat bone and joint infections.~   "
3682|NCT03009032|"~     Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a~     greater risk of clinical progression. Gut bacteria metabolism appears to impact immune~     recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and~     probiotics seem to exert immunological effects, the clinical implications in this key~     population remain unknown. This is a pilot multicenter randomized placebo-controlled, double~     blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS.~     Participants will be randomized (1:1) to either the synbiotic nutritional supplement~     PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes~     will be safety and immunological recovery. Secondary outcomes will include changes in fecal~     microbiota structure and plasma inflammatory markers.~   "
3683|NCT03009019|"~     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura,~     being conducted at multiple centers in the United States~   "
3684|NCT03009006|"~     The aim of this prospective in vivo randomized clinical trial to evaluate influence of~     combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2%~     (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste,~     Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and~     reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted~     necrotic teeth.~      According to the inclusion criteria the patients enrolled in the study and allocated~     randomly into three groups either combination of calcium hydroxide paste intracanal~     medication with 2% chlorhexidine gel. (group A) or calcium hydroxide paste intracanal~     medication only (group B) or mechanical preparation without intracanal medications (group C)~     the endodontic treatment is done at two visits.~      The samples of endotoxin divided into three groups: after access (S1), after mechanical~     instrumentations (S2), after removal intracanal medication (S3), all samples taken by a~     sterile paper points introduced in the root canal for the working length for 60 seconds.~      firstly the patient's medical and dental history is taken. the patients assign on informed~     consent. and then anaesthetized and access cavity performed and root canal preparation is~     done by Revo-s system then irrigation and intracanal medication placement inside to canal.~     the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2~     weeks after first visit. the operator will recall the patient to check the records~      second visit After 2 weeks from application of ICM, rubber dam will be applied then removal~     of the temporary dressing, then a sterile paper point (S3) will be introduced into the~     canals after irrigation and removal of the remnants of the intracanal medicament with the~     saline solution.~        -  Removal of the paper sample to determine the endotoxin concentration.~        -  The canals will be obturated by single cone technique using gutta percha point tapered~          0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final~          apical size of the file and the root canal sealer will be resin sealer (Adseal, META~          BIOMED CO., LTD, Korea).~        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first~          visit (at the day of the Obturation) before the beginning of Obturation.~   "
3685|NCT03008993|"~     INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality~     Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions~     recommended by international guidelines. This randomized trial is designed to assess whether~     the introduction of the strategy in oncology wards improves patient quality of life.~      METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized~     controlled trial, where the intervention strategy is sequentially carried out in three~     groups of centers (clusters with 5 centers each) and in three equally spaced time periods~     (epochs) (every 4 months). The study also includes an initial epoch during which none of the~     centers is exposed to the intervention, and a final epoch when all centers will have~     implemented the strategy . The intervention is applied at a cluster level (unit of~     randomization) and assessed at an individual level with cross-sectional model. 720 patients~     will be included, i.e. 60 patients in each cluster for every detection epoch.~      Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of~     improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,~     detected at baseline and 3 months after enrolment.~      The HQIS comprises three phases: 1) clinician training - to improve communication-relational~     skills and to instruct on the project; 2) center support - 4 on site visits by experts of~     the project team, aimed to introduce the project and boost motivation, instruct staff on how~     to implement recommendations, help with context analysis and identification of solutions;~     assess actual implementation in the center; 3) implementation of EBM recommendations.~      ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics~     Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and~     professional journals intended for policymakers and managers.~   "
3686|NCT03008980|"~     Patients will be recruited from participating institutions prior to planned routine care EGD~     with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients~     who are potentially eligible for the study will be approached regarding the study. If~     interested, participants will be consented and proceed with routine care EGD. The study~     coordinator or other research personnel will document information from the routine care~     endoscopy as part of this research study. Follow-up information collected will include~     WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy~     performed during the course of participation in the study, any surgeries received and~     related to their condition, and any other care received as part of their condition. WATS3D~     samples will be sent to CDx Diagnostics for analysis.~   "
3687|NCT03008967|"~     This project will be a descriptive, hypothesis-generating study. The aim is to identify risk~     factors for poor response to rehabilitation programs after TJR and use these to identify~     patients who are most susceptible to poor outcomes in order to optimise appropriate~     rehabilitations strategies and rationalising the distribution of health care resources.~   "
3688|NCT03008941|"~     Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to~     contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with~     nutritional interventions exert limited immunologic effects, but a deep understanding of how~     these interventions could ameliorate gut dysbiosis and influence health among HIV-infected~     individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on~     effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1~     will be included and randomized to either repeated low-dose oral fecal microbiota~     transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary~     outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio,~     inflammatory markers, T cell activation and markers of enterocyte barrier function through~     week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the~     V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint~     will be studied by combination of untargeted mass spectrometry and two different and~     complementary separation techniques in bacterial and plasma samples.~   "
3710|NCT03008655|"~     BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results~     from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid~     both showed efficacy on the treatment of melasma. However, no combination therapy of both be~     reported.~      OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low~     influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection~     for melasma.~   "
3895|NCT03006224|"~     Smoking and perhaps secondary smoking is associated with many perioperative and~     postoperative complications, especially respiratory events. Hypoxemia and airway damage can~     be associated with secondary smoking. The aim of study is to predict the incidence of~     hypoxemia and airway damage during one lung ventilation for lobectomy.~   "
3689|NCT03008928|"~     New technologies offer potential ways to provide and deliver preventative interventions.~     With respect to unhealthy alcohol use, offering people tools to assess and manage their risk~     at any given time using their smartphone may represent an additional opportunity to~     disseminate preventative interventions. Nevertheless, there is a lack of knowledge on the~     acceptability and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz,~     a smartphone app, has been previously evaluated using a before/after design without~     randomization, with participants reporting reductions in drinking over time. The current~     trial proposes to conduct an RCT, comparing reductions in alcohol consumption between~     participants provided access to Alcooquizz to a no intervention control.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential~     participants identified as problem drinkers based on an initial survey will be invited to~     complete another survey in 6 months time. Those who agree to be followed-up will be~     randomized to be provided a link to download the Alcooquizz app or to a no link control~     condition. At six-months post-baseline, the MTurk portal will be used to send invitation~     emails that contain a link to the follow-up survey that asks about their drinking and their~     impressions of the app. The primary hypothesis to be tested is that participants receiving~     access to the Alcooquizz app will report a greater level of reduction in number of drinks in~     a typical week between the baseline survey and six-month follow-up as compared to~     participants in the no information control condition.~   "
3690|NCT03008915|"~     The aim of this study is to test whether therapies in alpha-1 antitrypsin~     deficiency-associated lung disease improve endothelial function, measured by pulmonary~     microvascular blood flow on magnetic resonance imaging (MRI) and with apoptotic endothelial~     microparticles.~   "
3691|NCT03008902|"~     We are studying how spine movement changes with age, and when people have vertebral~     fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).~   "
3692|NCT03008889|"~     The purpose of this study is to demonstrate the feasibility of a 9-week, randomized trial of~     N-acetylcysteine (NAC) compared to placebo in 14 children (age 5 to 12 years) with Autism~     Spectrum Disorder (ASD) and a moderate level of repetitive self-injurious behavior (SIB).~     Additional aims are to evaluate the positive predictive value of a screening method to~     classify children with automatically maintained self-injurious behavior; to evaluate the~     preliminary efficacy of NAC for reducing repetitive SIB in children with ASD; and to~     evaluate biomarkers and possible mechanisms of action of NAC in children with ASD.~   "
3693|NCT03008876|"~     This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV~     ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm~     infants.~   "
3694|NCT03008863|"~     1. The investigators will design, test and implement a education curriculum for anesthesia~          residents teaching geriatric anesthesiology.~        2. The investigators will randomize 42 anesthesia residents so that half receive an~          innovative, e-learning curriculum while the other half receives the current standard~          curriculum. We will assess their medical knowledge, and the amount of anesthesia~          delivered to patients after the curriculum is implemented.~        3. The investigators will analyze any changes in clinical practice of residents in the~          care of elderly patients. Enrollment will be voluntary for all residents. Also, the~          investigators will not interfere with clinical management of any patients by residents~          which are done under direct supervision of faculty.~   "
3695|NCT03008850|"~     Shivering is a common post-anesthetic complication occurring in up to 65% of patients~     undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram,~     blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen~     consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result~     in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could~     therefore result in better postoperative outcomes or reduce the incidence of post-surgical~     complications.~   "
3696|NCT03008837|"~     Given recent increasing opioid-related deaths and evidence showing against the use of~     opioids for non-malignant chronic pain, there is growing need for non-narcotic pain~     management. Fibromyalgia is a difficult to treat chronic pain condition that is often~     treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased~     among Veterans returning from the gulf war and is already a significant burden in senior~     Veterans who may have suffered with chronic pain for decades already. Many treatment options~     for fibromyalgia carry intolerable side effects. PENFS (percutaneous electrical neural field~     stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within~     the military and VA system, but sufficient evidence regarding its outcomes and neural~     mechanisms have not been adequately investigated. An understanding of its neural~     underpinnings and analgesic effects could lead to 1) improvements in pain management and~     quality of life, 2) cost-savings and 3) development of new techniques to address pain.~   "
3697|NCT03008824|"~     There is a rapidly escalating epidemic of obesity and type 2 diabetes across the world, with~     the fastest rise occurring in low- and middle-income countries. India not only has one of~     the highest rates in the world, but the disease starts at a younger age and lower levels of~     body weight than in UK white caucasians. Among city-dwelling Indians, approximately 8% of~     people aged 30-40 years already have diabetes. This is creating a heavy burden of disease~     and disability, and an intolerable economic burden through medical costs and lost earnings.~     Until now, efforts to prevent diabetes have mainly focussed on modifying the diet, lifestyle~     and activity of at-risk adults (for example those who are overweight, have a family history~     of diabetes or already have high blood sugar). However, recent research has indicated that~     factors acting in early life (during development in the womb) place an individual at risk of~     later diabetes. These include maternal malnutrition and low birthweight, and diabetes in the~     mother during pregnancy. Our research has shown that Indian mothers often have low vitamin~     B12 levels, which in turn causes high blood levels of a harmful metabolite (homocysteine).~     We have shown that these mothers get more diabetes in pregnancy. Their children are more~     likely to born with a low birth weight, and develop more body fat and higher plasma insulin~     levels during childhood, which are signs of higher diabetes risk in later life. The risk is~     increased further if the mother has normal or high status for another B vitamin, folate.~     Thus, we have shown, for the first time a link between a specific nutritional deficiency in~     the mother and diabetes risk in the next generation. One possible mechanism for the effect~     of maternal nutrition on risk of diabetes in her children is through epigenetic effects,~     whereby the nutritional environment during early development affects the switches that~     control gene expression. Since these switches are passed on via either parent, we think it~     is possible that paternal vitamin B12 status could also be important.~   "
3698|NCT03008811|"~     This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon~     catheter versus a radiofrequency ablation with a contact force sensing catheter for~     treatment of patients with persistent or longstanding persistent atrial fibrillation.~   "
3702|NCT03008759|"~     The literature recognizes that fluoride is the most widely used and studied means for dental~     remineralization. The use of fluoride toothpaste in brushing is considered more rational~     method for the prevention of caries. However, the current challenge of toothpaste is the~     substantivity, so new compounds have been introduced into these formulations. This study~     aims to evaluate the in vivo effect of fluoride dentifrice containing nanoencapsulated~     Fluoride (Nano-F) - in fluoride retention in saliva and dental plaque. A study of the~     clinical and laboratory type, crossover, double-blind, randomized will be held. After sample~     calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed,~     missing, and filled teeth index less than 6 and residents in brazilian northeast capital~     will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and~     saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h~     after brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours~     after. It will be 3 toothpastes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated~     Fluoride and Free sodium fluoride. Between weeks of use, brushing will be extended washout~     (without fluoride) to avoid carryover effect. inferential data analysis will be carried out,~     considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the~     largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may~     have important impact on Des-Re process and in the control of dental caries~   "
3703|NCT03008746|"~     Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with~     chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was~     recently described using high-throughput sequencing techniques (NGS). PA strains isolated~     during lung infection episodes of severe COPD patients often show resistance to antibiotics~     including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard~     Medical School, the investigators have recently demonstrated that PA OprD mutant shows~     increased survival (fitness) and its virulence. This bacterium could be more likely to~     colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may~     worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective~     is to describe modification of pulmonary microbiota associated with PA colonization,~     including OprD PA mutant, in severe COPD patients. The investigators will correlate the~     microbiota modification to medical history. Stable severe COPD patients will be included.~     Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA~     OprD mutant colonized. Medical history will be recorded by the physician as usual and three~     samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular~     bacterial culture will be performed and NGS will be performed also to characterize the~     microbiota.~   "
3704|NCT03008733|"~     The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a~     promising growing field (1). Non-invasive and painless, ultrasound provides additional data~     electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being~     easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating~     Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and~     neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory~     neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the~     clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for~     monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently~     in several studies. However the limited resolution of current ultrasound images do not allow~     detailed study of the internal structure of the nerves which could later help deepen~     knowledge in this innovative field and can better understand the pathophysiological~     mechanism of the evolution of these pathologies .~      To do this, the investigators have available a UHF ultrasound in the ultrasound department~     of the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive~     analysis study, pilot, mono-centric, multi and prospective on patients followed in the~     center with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control~     subjects matched by age and sex. All the patients and controls in this study will receive a~     briefing and must sign an informed consent.~      They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound~     system that will allow the assessment of anatomical structures of nerve (size, structure,~     vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared~     with the data obtained with the EMG and clinical scores obtained using clinical rating~     scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a~     diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a~     diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of~     neuropathy at the EMG examination.~   "
3705|NCT03008720|"~     Introduction: It is suggested that increased cortical activity, induced by cerebral~     stimulation associated or not with other rehabilitation techniques, may potentiate the motor~     and functional therapeutic effects in individuals with neurological deficits. Objectives: To~     evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of~     individuals with hemiparesis due to stroke following treatment with transcranial direct~     current (tDCS) stimulation and functional electrical stimulation (FES), associated or~     isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both~     of which were collected at four different time points: pre-treatment, immediately after 10~     treatment sessions, and 30 days follow-up after the interventions. Patients will be~     randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction~     TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active~     contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over~     the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and~     FES over hemiparetic TA by a researcher who will not be the one who will evaluate the~     anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20~     minutes.~   "
3706|NCT03008707|"~     Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative~     to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD)~     (Modified Hinchey's classification grade II non responder to conservative therapy and grade~     III). Aim of the study is to evaluate wha surgical strategy, between LPL and LS could give~     better results in patients with CAD~   "
3707|NCT03008694|"~     This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment~     Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with~     historical control as defined in the protocol~   "
3708|NCT03008681|"~     The aim of the study was to determine the changes in Oral Health-Related Quality of Life~     (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint~     (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex~     group in which the functional therapy was most effective.~   "
3709|NCT03008668|"~     The investigators plan to undertake a rigorous multicentre randomised controlled trial,~     comparing acupuncture on sensitized acupoints versus non-sensitized acupoints, to test if~     acupuncture on sensitized acupoints may result in improved treatment outcomes in patients~     with Knee osteoarthritis (KOA).~   "
3711|NCT03008642|"~     The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has~     been used in the vast majority of studies in sport medicine. However, this method has never~     been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The~     standard procedure to evaluate the red cell mass is based on isotopic measurement using~     Cr51-labelled red cells, but its lack of availability in many centers highlights the need~     for a non-invasive and rapid alternative method. The purpose of this study is to evaluate~     and validate the CO-Rebreathing method in this set of indications.~   "
3712|NCT03008629|"~     Background: Ingrown toenails are one of the most frequent nail disorders and can be treated~     with conservative or surgical approaches. Although discovered a long time ago, the available~     data are still very limited on the potential effectiveness of nail braces for ingrown~     toenail treatment.~      Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix)~     for treatment of ingrown toenails.~   "
3713|NCT03008616|"~     This study evaluates the use of Digoxin immune fab in addition to expectant management in~     the treatment of severe preeclampsia as compared to placebo.~   "
3714|NCT03008603|"~     This is a prospective, single-arm study is to evaluate the safety, effectiveness and~     usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous~     procedures in the interventional radiology suite, e.g., core biopsy, will participate in the~     summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will~     also be evaluated.~   "
3715|NCT03008590|"~     Over 100 million Americans report chronic pain. Veterans are disproportionately affected for~     multiple reasons, including injuries and post-traumatic stress disorder. Treatment for~     chronic pain is a priority research area for the VA. One of the most common causes of~     chronic pain is osteoarthritis (OA). OA is attributable to wear and tear, but reasons for~     pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect~     2-3% of persons and require treatment with immune-suppressive drugs to prevent joint~     destruction. Pain often persists despite effective treatment. Pain in arthritis results from~     multiple sources: inflammation, perception of pain in the joint, and interpretation of pain~     by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose~     naltrexone is a widely used but unproven alternative approach to chronic pain. It is~     attractive for study because it is safe and is proposed to work on all three pathways that~     contribute to pain. A small but high-quality clinical trial is needed to determine whether~     to invest in definitive studies.~   "
3716|NCT03008577|"~     Neonatal hypothermia is associated with increased risk of mortality as well as multiple~     morbidities. The prior HEAT study conducted at our institution showed a difference in~     neonatal hypothermia with a change in ambient operating room temperature. The investigator's~     objective is to determine if an increase in ambient operative room temperature decreases the~     rate of neonatal morbidity. Operating room temperature will be randomized to the current~     institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for~     a period of 1.2 years.~   "
3717|NCT03008564|"~     There has been dispute about the location at which the adductor canal block should be~     performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal~     blocks with the 'point of entry' being:~        1. Point A: midway point between the ASIS and base of patella~        2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes~          the popliteal artery as it traverses away from the sartorius muscle towards the femur~          at the adductor hiatus (2)~      We want to determine ultrasound anatomy in healthy volunteers by:~        1. Measuring the distance between Point A and Point B~        2. Studying the ultrasound anatomy at Point A and B - Determine their location with~          respect to the adductor canal and femoral triangle.~      This will allow us to determine which is the best site for performing an adductor canal~     block~   "
3718|NCT03008551|"~     This a randomised open-label parallel study involving women with polycystic ovary syndrome~     (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg~     daily for three months. The aim of the study is to examine the effect of empagliflozin on~     hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.~   "
3719|NCT03008538|"~     Studying the comparative effectiveness of socket preservation using autogenous bone graft~     versus MPM for implant insertion.~   "
3720|NCT03008525|"~     Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including~     calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a~     hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family)~     leading to the production of the 25(OH)D, which corresponds to the circulating form of the~     VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the~     kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous~     epidemiological studies reported an inverse relationship between obesity and circulation~     level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in~     obese subjects, the more classical evoked being based on sequestration and/or dilution of VD~     in adipose tissue (AT), the main VD storage site. However, this mechanism has never been~     demonstrated. In order to confirm this hypothesis, the concentration of VD and its~     metabolites in adipose tissue need to be quantified.~      The objective of this study is to determine the concentration of VD and its metabolites in~     adipose tissue as well as adipose tissue mass quantification and distribution (visceral or~     subcutaneous) to highlight putative difference of VD and its metabolites quantities between~     obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid~     metabolism gene expression will be realized on biopsies. Correlations between gene~     expression and quantity of VD in tissue will be carrying out.~   "
3721|NCT03008512|"~     This study evaluate activity and safety profile of weekly Genexol-PM in patients with~     advanced hepatocellular carcinoma for whom sorafenib treatment failed. Patients will receive~     Genexol-PM on days 1, 8, and 15 every 4 weeks.~   "
3722|NCT03008499|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of colorectal cancer.~   "
3723|NCT03008486|"~     The purpose of this study is to assess the effects on upper limb spasticity of soft splints~     worn during three weeks three hours a day by patients with stroke or disorders of~     consciousness.~   "
3724|NCT03008473|"~     Glidescope and chest CT iminge for the placement of the Univent Tube Without Fiberoptic~     Bronchoscope Assistance~   "
3725|NCT03008460|"~     The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic~     sulphate-based laxative preparation given on the day before colonoscopy has non-inferior~     efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in~     adolescents aged 12 to 17 years (inclusive) with a body weight ≥40 kg, scheduled to undergo~     a colonoscopy for a routinely accepted diagnostic indication.~   "
3726|NCT03008447|"~     E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change~     from baseline in postural stability (worsening) when participants are awakened at~     approximately 4 hours postdose is significantly less after lemborexant than after zolpidem~     tartrate extended release following a single-dose administration at bedtime.~   "
3727|NCT03008434|"~     This long-term goal of this project was to advance best practices in occupational therapy in~     conjunction with yoga. To address the long-term goal, this research team developed a pilot~     yoga intervention. The intervention was designed to focus on balance, balance confidence,~     body responsiveness, pain, physical ability and quality of life. Assessments were then~     chosen to address these areas pre and post yoga intervention. A manual and protocol were~     developed for the intervention and then the intervention was implemented with a group of~     individuals with chronic traumatic brain injury.~   "
3728|NCT03008421|"~     In the present study, the investigators aim to evaluate the potential of oral probiotics,~     containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with~     group B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity~     and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as~     early-onset or late-onset GBS infection.~   "
3729|NCT03008408|"~     The goal of this clinical research study is to learn if the combination of everolimus,~     letrozole, and ribociclib can help to control recurrent (has returned after treatment) or~     progressive endometrial cancer. The safety of this drug combination will also be studied.~   "
3730|NCT03008395|"~     Outcomes in type 2 diabetes are largely achieved by self-management efforts by individuals~     living with diabetes. Diabetes self-management is typically provided using the principles of~     adult education. Current evidence suggests that standard educational interventions are~     suboptimal. This study evaluates a novel approach to diabetes self-management using dialogue~     tools based on empowerment and motivational communication methods. The approach evaluated in~     this study is called EMMA: empowerment, motivation and medical adherence. Participants will~     be randomized to EMMA and treatment as usual, treated for a period of 4 months and evaluated~     over a period of 12 months.~   "
3731|NCT03008382|"~     Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) afflicts 3 to 8 million women in the~     US. Symptoms of IC/BPS reduce quality of life, suppressing both social well-being and~     physical function. The chronic pain, voiding dysfunction, sleep deprivation and associated~     co-morbid conditions interfere with relationships and employment with significant direct~     (doctor visits, medication, surgery) and indirect (loss of productivity) economic impact,~     currently exceeding $100 million per year.This proposal aims to move the science of chronic~     pelvic pain (CPP) from simple associations towards an investigation of cause and effect~     relationships. The investigators will determine whether the striking changes in autonomic~     nervous system responsiveness (ANS-R) contribute meaningfully to the pathogenesis of IC/BPS.~   "
3732|NCT03008369|"~     This phase II trial studies how well lenvatinib works in treating patients with~     pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be~     removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
3733|NCT03008356|"~     We hypothesize that supplementation with L-carnitine that is available both as an~     FDA-approved therapy for primary carnitine deficiency, as well as widely available as an~     over-the-counter ergogenic aid will improve wellbeing and function measured by~     questionnaires in patient with chronic obstructive pulmonary disease (COPD).~      We further hypothesize based on our review of literature that addition of health coaching~     (HC) to L-carnitine will yield greater gains.~   "
3734|NCT03008343|"~     The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus~     natural killer (NK) immunotherapy to recurrent liver cancer.~   "
3735|NCT03008330|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of tongue cancer.~   "
3736|NCT03008317|"~     a split mouth randomized clinical trial that compares quantity and quality of bacterial~     adhesion under both PEEK versus cobalt chromium alloy denture base.~   "
3737|NCT03008304|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of pancreatic cancer.~   "
3738|NCT03008291|"~     Participants in this study will either have heart failure (HF) and are scheduled to undergo~     cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy~     defibrillator (CRT-D) implantation, or have atrioventricular (AV) block and are scheduled to~     undergo dual chamber pacemaker implantation. In this study additional heart rhythm~     measurements will be collected during the implant procedure to better understand how His~     bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of~     patients with HF or AV block.~      The hypothesis is that His bundle or parahisian pacing (HISP) may normalize atrioventricular~     (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in~     functional bundle branch block or conduction delay in patients with heart failure (HF).~   "
3739|NCT03008278|"~     This pilot phase I/II trial studies the side effects and best dose of olaparib when given~     together with ramucirumab and how well they work in treating patients with gastric or~     gastroesophageal junction cancer that has spread to other places in the body, has come back,~     or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Monoclonal antibodies, such as ramucirumab, may~     interfere with the ability of tumor cells to grow and spread. Giving olaparib and~     ramucirumab may work better in treating patients with gastric or gastroesophageal junction~     cancer.~   "
3740|NCT03008265|"~     Nationwide cohort study on short- and long-term mortality of patients with and without~     postoperative fascial dehiscence.~      The cohort will be comprised of patient undergoing open colonic resection for colonic cancer~     registered in the Danish Colorectal Cancer Group Database. The exposure is fascial~     dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.~   "
3741|NCT03008252|"~     In the last few years a new clinical entity has emerged which includes patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even~     though they do not have celiac disease (CD) or wheat allergy. This clinical condition has~     been named non-celiac gluten sensitivity (NCGS), although in a recent article, the~     researchers suggested the term non-celiac wheat sensitivity (NCWS), because it is not~     known to date what component of wheat actually causes the symptoms. The clinical picture of~     NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea~     and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis)~     and extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy~     mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm~     numbness, and anemia). Lactose intolerance and cow's milk protein allergy (CMPA) are two~     medical conditions with a very high prevalence in the general population, and there is a~     large overlap between NCWS symptoms and lactose intolerance and CMPA symptoms. Therefore,~     the aims of the present study are to investigate 1) the prevalence of positive lactose~     breath test and DBPC cow's milk protein challenge in NCWS patients with self-reported~     gastrointestinal symptoms related to milk and/or milk derivates ingestion, 2) the clinical,~     serological, and histological characteristics of NCWS patients with lactose intolerance and~     CMPA in comparison to NCWS patients without lactose intolerance and CMPA.~   "
3742|NCT03008239|"~     This study evaluates the performance and safety of the fluorescence based fibre optic~     glucose sensor for home usage.24 subjects will take part in the study, including 4~     pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4~     diabetic patients who require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type~     2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the~     upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom~     sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4~     CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No~     additional comparator sensor will be placed in CAPD subjects.~   "
3743|NCT03008226|"~     The purpose of this observational study is to investigate the efficacy of 9 mm~     intrabronchial valve treatment in patients with heterogeneous emphysema and to gain further~     insights and experience on the treatment with this valve size.~   "
3744|NCT03008213|"~     Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important~     in treatment of cancer patients. CINV is one of the most distressing severe side effects of~     cancer treatment and can have a significant impact on a patient's quality of life. The~     chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into~     two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy~     (HEC). Nausea and vomiting that occurs within the first day of the administration of~     chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours~     of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV~     occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs~     preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in~     controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of~     Akynzeo in the treatment of refractory CINV~   "
3745|NCT03008200|"~     Fetal PATET ratio evaluation to predict neonatal RDS~   "
3746|NCT03008187|"~     Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of~     SEL24 in patients with AML.~      At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.~      In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in~     patients who are unfit to receive intensive chemotherapy.~   "
3747|NCT03008174|"~     Patients with tracheostomy who are on and off of mechanical ventilation initially lose the~     ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring~     speech in these patients. Patients with tracheostomy who experience loss of speech report~     frustration and feelings of confinement from their communication impairment, therefore~     investigators would like to restore speech in these patients as soon as it is safe to do so.~     However, there is currently little known in the literature about the timing of the use of~     OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test~     post-test clinical trial pilot study to investigate the safety of early use of OWSV in~     patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who~     would benefit from the early use of OWSV and to determine the effects of early use of OWSV~     on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous~     tracheostomy will be screened, and patients meeting screening criteria will be randomized~     into intervention and control groups. The intervention group will receive early~     speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following~     tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV~     trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will~     been compared on speech and clinical outcomes measures from pre-test at 12-24 hours~     following tracheostomy and post-test at 48-60 hours following tracheostomy and~     characteristics of patients who successfully tolerate early OWSV use will be identified.~   "
3748|NCT03008161|"~     The purpose of the study is to evaluate the safety and tolerability of multiple doses of~     NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also~     evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic~     characteristics of multiple doses of NPT088.~   "
3749|NCT03008148|"~     This is a multi-center, phase II/III, open-label, randomized, parallel and standard~     chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to~     receive control treatment or study treatment. The primary objective of this trial is to~     evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall~     survival (OS) on newly diagnosed glioblastoma (GBM) patients.~   "
3750|NCT03008135|"~     This study evaluates the reliability of the French version of the elderly mobility scale~     and its correlation with the frailty elderly scale ~   "
3781|NCT03007732|"~     This is a non-comparative open-label multicenter Phase 2 clinical trial combining definitive~     prostatic radiotherapy (RT) and pembrolizumab with or without intratumoral SD-101 in~     patients with newly diagnosed hormone-naive oligometastatic prostate cancer.~   "
3896|NCT03006211|"~     To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that~     operated under N2O + sevoflurane and O2 + sevoflurane general anesthesia.~   "
3751|NCT03008122|"~     This study is randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation~     study to evaluate the safety, reactogenicity, and immunogenicity of Alum Adjuvanted Zika~     Virus Purified Inactivated Vaccine (ZPIV) administered to healthy male and non-pregnant~     female adult subjects. This study will enroll 90 healthy male and non-pregnant female~     subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School~     Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The duration of each subject's participation~     is approximately 26 months from recruitment through the last study visit. The entire study~     is expected to take approximately 40 months to complete. Two dose levels will be evaluated.~     Each subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV~     administered by intramuscular (IM) injection on Days 1 and 29. Solicited local and systemic~     reactogenicity data will be collected from all subjects through Day 8 after each~     vaccination. All subjects will be monitored for occurrence of unsolicited adverse events~     until 28 days after the second vaccination. The study will consist of a screening period of~     up to 28 days, a vaccination period in which subjects will receive a prime dose of vaccine~     on Day 1 followed by a boost on Day 29, and a follow-up period of 24 months post boost~     vaccination. Primary objectives are: 1) Assess the safety and reactogenicity of a homologous~     prime boost regimen of ZPIV given at two different dose levels. 2) Compare the safety and~     reactogenicity of ZPIV after each vaccination, between dosage groups, and by pre-vaccination~     flavivirus immune status.~   "
3752|NCT03008109|"~     EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR~     mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS~     （progression-free survival） , the OS （ overall survival） is limited extended. This study is~     aim to observe the safety and efficacy of the combination of an anti-angiogenic drug~     recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further~     extend the PFS and OS with a tolerated toxicity.~   "
3753|NCT03008096|"~     In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety~     and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index~     (BMI) within listing criteria for heart transplantation. To our knowledge, this is the first~     prospective study to evaluate laparoscopic sleeve gastrectomy in LVAD patients as~     bridge-to-candidacy for heart transplantation.~   "
3754|NCT03008083|"~     This study is a prospective,multi-center, open-label, randomized controlled clinical~     trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months~     (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous~     coronary intervention implanted sirolimus target- eluting stent with abluminal grooves~     containing a biodegradable polymer (Firehawk™ stent). All participants met the inclusion~     criteria begin taking aspirin and open-label thienopyridine therapy before index procedure,~     and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.~   "
3755|NCT03008070|"~     Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may~     progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes~     mellitus, or insulin resistance and is very common. However, Treatment of NASH is a~     significant unmet clinical need.~      IVA337 is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist~     addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.~      The purpose of this research is to evaluate the efficacy and the safety of two doses of~     IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with~     liver steatosis and moderate to severe necroinflammation without cirrhosis.~   "
3756|NCT03008057|"~     The aim of this study is to determine the effects of vitamin D or placebo for 3 months on~     the gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood~     mononuclear cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of~     diabetes type 2 patients.~   "
3757|NCT03008044|"~     This is a single center prospective study. The purpose of this study is to assess the~     performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to~     hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in~     healthy volunteers.~   "
3758|NCT03008031|"~     The optimal dose of iodine based contrast agents used in contrast-enhanced spectral~     mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast~     agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients~     can receive less contrast agent for CESM in future and thereby risking less side effects of~     the contrast agent.~      In order to study whether CESM remains unchanged at smaller amounts of contrast~     administration, a second CESM exam will be performed within one week of the first with a an~     alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast~     dose. The settings of the CESM unit will remain unchanged.~   "
3759|NCT03008018|"~     The aim of the study is to evaluate the safety/tolerability, pharmacokinetic, and~     pharmaco-dynamic effects of KA2507 and establish the maximum tolerated dose (MTD). Patients~     with PD-L1 expressing solid tumors which have relapsed or are refractory to prior treatment~     will be eligible to participate in this study.~      Following completion of the multiple ascending dose study, the protocol may be amended to~     include expansion cohorts in patients with melanoma and/or other solid tumors.~   "
3760|NCT03008005|"~     The goal of this study is to look at how a type of drug called cannabinoids are related to~     the processing of fear signals, the experience of emotions and fear, and the pattern of~     activity in the brain that is involved in these processes and how this relates to the~     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that~     occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of~     the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the~     person of the event, difficulty experiencing emotions, loss of interest in activities the~     person used to enjoy, and increased arousal, such as difficulty falling asleep or staying~     asleep, anger and hypervigilance. The information gained from this study could lead to the~     development of new treatments for persons who suffer from anxiety or fear-based disorders.~   "
3761|NCT03007992|"~     The purpose of the trial is to investigate the efficacy of metronomic treatment with daily~     oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in~     patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.~   "
21674|NCT02773498|"~     To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50~     years-old men with non obstructive azoospermia.~   "
3762|NCT03007979|"~     The investigators propose to conduct a study to test an alternative dosing schedule of~     palbociclib. With the current three-week on and one week off schedule, a significant number~     of patients develop grade 3 or higher degree of neutropenia and require dose reduction and~     sometimes discontinuation. This potentially compromises the efficacy of the drug. In~     addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3~     weeks on and 1 week off dosing schedule could potentially lead to recovery of Rb~     phosphorylation during the off week. Hence, the investigators propose a 5 days on and 2 days~     off schedule each week without any weeks off drug. Although the cumulative doses each 28-day~     cycle is roughly the same with this schedule compared to conventional dosing, the bone~     marrow is not exposed to the drug continuously for 21 days and rather gets frequent breaks~     from therapy. The investigators hypothesize that the 5 days on and 2 days off schedule is~     more tolerable with less frequent high grade neutropenia and dose interruption/reduction. In~     addition, this schedule also provides for a more continuous drug delivery to the patient~     since there is not a week's break in therapy, which could ultimately prove to be more~     efficacious.~   "
3763|NCT03007966|"~     Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain~     can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be~     treated with opioid therapy, but the literature supports that these agents are known to~     create or exacerbate adverse effects and complications, including post-operative nausea and~     vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional~     anesthesia results in a decreased risk of the aforementioned complications.1 Because of~     this, various regional anesthetic techniques have been developed to provide analgesia~     following open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric~     nerve block (IINB), which has been shown to decrease the initial pain after inguinal~     herniorrhaphy.2 The quadratus lumborum block (QLB) is a newer regional anesthetic technique~     that we think could be as effective as IINB at providing pain control following open~     herniorrhaphy. Additionally, because local anesthetic injected during a QLB has the~     potential to spread cranially into the thoracic paravertebral space following its lumbar~     deposition it could lead to alleviation of both somatic and visceral pain.3 This might~     therefore improve the quality and or duration of analgesia as compared to the IINB. To the~     best of the author's knowledge there has been no investigation comparing the efficacy, with~     regards to post-operative pain management, between IINB and QLB.~   "
3764|NCT03007953|"~     The focus of the study is to test a nurse-led telephone-based palliative care intervention~     on improving the delivery of care for patients with newly diagnosed lung cancer. The study~     is a two site randomized control trial to determine the efficacy of the intervention on~     improving patients' quality of life, symptom burden, and satisfaction of care. Additionally,~     the study will test an innovative care delivery model to improve patients' access to~     palliative care. The investigators will also determine the effect of the intervention on~     patient activation to discuss treatment preferences with their clinician and on clinician~     knowledge of patients' goals of care.~   "
3765|NCT03007940|"~     This is an implementation research study designed to evaluate a defined strategy, NIATx, for~     its effectiveness in installing and sustaining evidence-based integrated services for~     persons with co-occurring substance use and mental health disorders. This study is a cluster~     randomized wait-list control group design, in which a cohort of 25 addiction treatment~     agencies receives the active NIATx approach during an index 12 month period. The second~     (wait-list) cohort of 25 addiction treatment agencies activates NIATx strategies during a~     second index 12 month period. The primary subjects of the research are the treatment~     agencies themselves. The study specific aims are:~        1. Relative to wait-list, to determine if NIATx strategies improve implementation outcomes~          (integrated service fidelity and receipt of more integrated services)~        2. Relative to wait-list, to determine if NIATx strategies improve patient care outcomes~          (psychiatric, alcohol and drug problem severity)~        3. Across entire sample, to evaluate variation in the extent of and fidelity to NIATx~          strategies~      NIATx implementation strategies consist of learning sessions, individualized coaching and~     peer to peer sharing.~   "
3766|NCT03007927|"~     To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual~     treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia~     Repair Mesh~   "
3767|NCT03007914|"~     The aim of this study is to compare the effectiveness of the treatments in two cohort for~     COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and~     have certain effect; the other, conventional medicine treatments cohort, based on 2015~     Global Initiative for Chronic Obstructive Lung Disease (GOLD).~   "
3768|NCT03007901|"~     To work with community partners to pilot test a mindfulness-based behavioral program aimed~     at: (a) enhancement of health and well-being, and (b) reduction in carbon footprint; (2) to~     develop, implement, and refine methods for assessing carbon footprint at the individual~     level; and (3) to work with pilot participants and community partners to carry out a~     proof-of-concept research study to assess impact on health, well-being, and carbon~     footprint.~   "
3769|NCT03007888|"~     Primary Objective:~      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate~     release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).~      Secondary Objectives:~      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.~      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.~      To evaluate the safety of IPX203.~   "
3770|NCT03007875|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of non-small cell lung cancer.~   "
3782|NCT03007719|"~     This is a single-center cross-sectional imaging study in patients with localized bladder~     cancer undergoing neoadjuvant atezolizumab as part of a companion clinical trial~     (NCT02451423; Phase 2 study of atezolizumab in non-metastatic bladder transitional cell~     carcinoma), and patients with locally advanced or metastatic bladder cancer receiving~     standard of care (SOC) atezolizumab. For the neoadjuvant cohort, study participants will~     undergo whole body PET(Positron Emission Tomography)/MR(Magnetic Resonance) imaging with~     [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. For~     the SOC cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG~     within 7 days of initiating atezolizumab and between Day 14 and Day 21 of Cycle 1~     atezolizumab.~   "
3771|NCT03007862|"~     Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac~     arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post~     cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without~     use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy~     of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in~     patients successfully resuscitated after out-of-hospital cardiac arrest.~      In this prospective non interventional study we included patients resuscitated after cardiac~     arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar~     lavage using specific display (Combi-Cath) was executed immediately after admission for each~     patient with both biochemic and bacteriological analysis including dosage of bronchial~     salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial~     and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical~     and biological criteria. On this basis we intended to determine a threshold measure of alpha~     amylase predicting occurrence of aspiration pneumonia and allowing a guidance in~     antibiotherapy prescription. Sensibility and Specificity of this technique were determined.~   "
3772|NCT03007849|"~     Patients with sickle cell disease often develop painful crisis without any obvious reasons.~     Some patients are more likely to develop this complication than others. It is now clear that~     painful crisis only occurs when sickled red blood cells stick to white blood cells that have~     been activated, usually by inflammation or infections. A recent study in mice with sickle~     cell disease showed that the use of long term antibiotics could reduce the number of~     activated white blood cells and reduce death of the mice during sickle cell crisis.~      The investigators believe that sickle cell patients who develop frequent painful crisis may~     have a different pattern of bacteria in their intestine when compared to those whose painful~     crisis occurs infrequently. In this study, the investigators propose to study sickle cell~     subject's blood to determine how many activated white blood cells he/she have. The~     investigators will also examine his/her stool to compare the bacteria in his/her stool to~     those other sickle cell patients. The investigators will then investigate whether or not the~     results from the blood and stool tests correlate with how frequently the patient develops~     painful crisis.~      The investigators will examine the patients' medical records to find out how many times they~     have been admitted to the hospital for sickle cell crisis in the last 12 months. The~     investigators will also obtain information on the following: their age, their sex, whether~     they are taking hydroxyurea or Penicillin, when they last had a transfusion or exchange~     transfusion therapy and painful crisis needing hospital admission, whether they have~     received any antibiotics (other than Penicillin) in the last 4 weeks, and whether they are~     experiencing a painful crisis at the time that they enter the study. The investigators will~     obtain, from their previous laboratory results, their levels of hemoglobin F and markers of~     inflammation. The investigators will check their hemoglobin F level if they have not already~     had this tested.~      The investigators expect to enroll 50 subjects into this study at Rhode Island~     Hospital/Hasbro Children's Hospital.~   "
3773|NCT03007836|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of nasopharyngeal cancer.~   "
3774|NCT03007823|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of melanoma.~   "
3775|NCT03007810|"~     Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the~     treatment of psoriasis. This study is the first administration of Hemay005 in humans to~     establish the initial safety, tolerability, and pharmacokinetic profile following single~     doses of Hemay005. A total of approximately 44 subjects will be randomized into 6~     cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be~     enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1~     placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study~     includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit~     occurring approximately 11days (±3 days) after study drug administration.~   "
3776|NCT03007797|"~     Introduction:~      In 2010, the vaccination recommendations for pregnant women against seasonal influenza were~     published by the German Standing Committee on Vaccination (STIKO). This work deals with the~     immunization coverage and the influencing factors.~      Method:~      A cross-sectional study was realized at two Level 1 perinatal centers in two German federal~     states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed~     by using a standardized and pre-tested questionnaire covering their knowledge about the~     influenza vaccination and other factors influencing the vaccination decision. Furthermore,~     data from the vaccination card and the pregnancy record booklet have been evaluated.~   "
3777|NCT03007784|"~     Limited treatments are available to improve consciousness in severely brain injured~     patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that~     showed evidence of efficacy to increase level of consciousness and functional communication~     in some minimally conscious state (MCS) patients, and in some vegetative state (VS)~     patients. However the optimal intensity of electrical current stimulation remains unknown.~      This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or~     2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the~     Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during~     resting state (using algorithms previously designed and published by the investigators) and~     event-related potentials (using auditory paradigms we previously published) in severely~     brain damaged patients with disorders of consciousness (MCS, VS, and conscious but~     cognitively disabled patients) of various etiologies.~   "
3778|NCT03007771|"~     This study will help to elucidate the treatment sites in the extremities and pelvis for~     which MR-guided HIFU heating is feasible, which has the potential to be beneficial for~     patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The~     investigators anticipate that successful completion of this study will lead to clinical~     trials in those feasible sites of interest to determine the safety and efficacy of~     administering therapeutic levels of heat for hyperthermia or other applications.~   "
3779|NCT03007758|"~     The purpose of this study is to determine how the robotic retromuscular hernia repair~     compares to the open retromuscular hernia repair for large hernia defects in patients at~     higher risk of wound complications.~   "
3780|NCT03007745|"~     Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and~     recognized as a major public health concern, most Veterans with this disorder are~     undiagnosed and therefore untreated. Access to sleep laboratories for testing is limited~     particularly for those Veterans living in rural areas and Veterans with disabilities that~     prevent travel to a sleep center. The goal of this study is to compare a web-based~     telehealth management strategy to in-person management. The telehealth pathway will enable~     Veterans to be diagnosed and treated without visiting a sleep center. The investigators~     believe that telehealth management will increase Veterans' access to this specialized care~     at a cost that is less than in-person delivery but with similar improvements in daytime~     function.~   "
22650|NCT02760823|"~     The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an~     adjuvant in the management of patients with acute phosphide poisoning.~   "
3788|NCT03007641|"~     The purpose of this study is to enhance the care of older metastatic breast cancer (MBC)~     patients by increasing awareness among oncology providers as to the unique aspects of care~     required for older patients. The goal of the study is to educate providers on the utility of~     geriatric assessment in guiding therapy of older metastatic breast cancer patients. The~     investigators will also assess the feasibility and benefit of incorporating geriatric~     self-assessments into clinical practice. The study will include three phases.~   "
3789|NCT03007628|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety among schizophrenia patients. Half of the participants will be randomized to MST~     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).~   "
3790|NCT03007615|"~     To evaluate the safety of an investigational product through the verification of signs of~     irritability and sensitization of the genital mucosa, as well as the instrumental~     moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy~     perceived by the volunteers.~   "
3791|NCT03007602|"~     Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes~     with the involvement of blood, bone marrow or other organs.There are various treatment~     options for hematological malignancies ranging from follow-up to single or multiple agent~     chemotherapy, radiotherapy, immunotherapy and autologous or allogeneic stem cell~     transplants. The general recommendation for patients is to relax and avoid intense exercise,~     regardless of the devastating consequences of neglecting physical exercise. Patients also go~     to relaxation by reducing their activity to avoid fatigue, which leads to loss of muscle~     strength and endurance in patients. As a consequence of all, fatigue, vomiting, weight loss,~     anemia, depression, decrease in aerobic capacity, loss of muscle strength, decrease in~     physical function and worsening of quality of life are observed in stem cell recipients. It~     has been shown that physical exercises improve oxygen consumption, depression and fatigue,~     cardiorespiratory fitness, muscle strength and physical well-being in patients with~     hematologic malignancies being stages of various treatment. In literature, effects of upper~     extremity aerobic exercise have been investigated in patients with spinal cord injury,~     neuromuscular diseases, claudication, hypertension, multiple sclerosis, heart failure,~     paraplegic patients and healthy individuals. Results of these studies has shown that upper~     extremity aerobic exercise improves walking distance, increases oxygen pulse, muscle~     strength and endurance of upper extremity. No study was observed to investigate the effects~     of upper extremity aerobic exercise on exercise capacity and quality of life in~     hematopoietic stem cell recipients, according to our knowledge. For this reason, our aim is~     to investigate the effects of upper extremity aerobic exercise on exercise capacity and~     quality of life in hematopoietic stem cell recipients.~   "
3792|NCT03007589|"~     The purpose of this study is to assess how sunscreens and sun protection fabrics perform in~     natural sunlight compared to their labeled claims, indoor testing methods (existing or~     modified) and instructions.~   "
3793|NCT03007576|"~     Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an~     important mission to develop a new treatment for OA. Recently, cellular therapy is a new and~     popular medical treatment around the world, one of them is Mesenchymal Stromal Cells~     (MSCs). MSCs are found in many tissues of human body and play an important role for~     repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for~     osteoarthritis treatment becomes a developing target for new generation drugs.~      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject.~     When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen~     tank until all release tests passed. On the distribution day, cell will be thawed and~     injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product~     infusion of seven days, one month, six months and one year. The monitoring items include the~     changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by~     questionnaire).~   "
3794|NCT03007563|"~     Neonatal jaundice is a common and most often harmless condition. However, when unrecognized~     it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated~     to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in~     most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease~     is therefore to identify then children at risk. This results in the need for low-cost,~     reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.~      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a~     smartphone application has been developed. This prototype will be evaluated in a clinical~     trial at St.Olav Hospital, Trondheim, Norway. A smartphone will be used to take picture of~     the skin of the newborn, and by using an algorithm an estimate of the bilirubin~     concentration is made. The results from these estimates will be compared to the bilirubin~     levels measured in standard blood samples, as well as the results from ordinary~     transcutaneous measurement devices.~   "
3795|NCT03007550|"~     This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy~     (LTG) and open total gastrectomy (OTG) in patients with clinical stage I~     (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the~     early operative morbidity and mortality and determine the safety of LTG compared with OTG~     for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery~     course and compare the postoperative hospital stay of the patients enrolled in this study.~   "
3796|NCT03007537|"~     To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney~     injury, and trying to provide evidence for protecting the renal function and improving the~     prognosis for patients after cardiac surgery.~   "
3797|NCT03007524|"~     This is a prospective, randomized trial comparing different doses of rosuvastatin in~     patients with acute coronary syndrome post drug-eluting stents implantation. Through the~     study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on~     target vessel endothelialization and non-target vessel plaque stability. Moreover, the~     investigators may provide mechanically evidence of clinical application of high dose~     rosuvastatin in patients with acute coronary syndrome.~   "
3798|NCT03007511|"~     A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device~     on 15 adult patients with a need for enteral feeding. The primary outcome will be to~     evaluate safety, usability and discomfort throughout the study~   "
3799|NCT03007498|"~     Check the safety under normal conditions of use through the verification of emergence signs~     of irritability and sensitisation of the genital mucosa.~   "
3809|NCT03007355|"~     Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of~     hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue~     perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a~     noninvasive new monitoring, can reflect the peripheral perfusion dynamics.~      This study is designed to explore the behavior and trend of PPI during deliberate~     hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery~     (FESS).~   "
3800|NCT03007485|"~     Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause~     of hospitalization for older adults in the U.S., and a leading cause of death. Although~     there is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines~     exercise and education, can help decrease re-hospitalizations and improve patients' quality~     of life. Unfortunately, very few COPD Latino patients actually get PR. These patients are~     unlikely to get referrals or to be able to attend PR due to lack of insurance, lack of~     transportation, or lack of a PR center in their area. Telehealth is a way of using computers~     to deliver healthcare long-distance, eliminating the need for a patient to travel to receive~     care. By using telehealth for PR, the patient can exercise on a stationary bike in his or~     her home, while being supervised by videoconference by a respiratory therapist (RT). The RT~     can see the patient, and deliver education by videoconference, and the patient can see~     the RT, so the patient does not need to leave home to get PR.~   "
3801|NCT03007459|"~     Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates~     and inspires followers through social media. We want to study the effect of such lifestyle~     on selected aspects of psychological and physical health in female fitness athletes, and~     compare the outcomes to a healthy, physically active female population.~   "
3802|NCT03007446|"~     This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial~     evaluating the efficacy and safety of Convension Surgery for Apatinib plus SOX for patients~     with unresectable gastric cancer.~   "
3803|NCT03007433|"~     Dyspeptic symptoms such as abdominal pain, bloating and nausea after a meal are common;~     however the cause of these problems in many patients is often unclear despite medical~     investigation. This is because dyspeptic symptoms are only rarely related to acid reflux,~     stomach ulcers or cancer that can be diagnosed by endoscopy. Rather, the cause is abnormal~     stomach function, so-called functional dyspepsia, a condition in which the digestive~     system does not function normally after a meal. Gastric scintigraphy is the standard~     investigation of stomach function in patients with this condition. It involves eating a~     small test meal that includes a tiny dose of radioactive material so that the movement of~     food can be visualised as it empties from the stomach. An important limitation of this~     approach is that symptoms are rarely caused and delayed emptying after a small meal is~     present only in a minority of patients and, thus, the ability of this investigation to~     explain the cause of symptoms or guide medical treatment is limited.~      This research project is designed to compare three new investigations of stomach function~     using a relatively large meal. This information will help to explain the causes of symptoms~     after a meal. The investigations to be tested include: (1) Nutrient Drink Test, (2) Gastric~     Scintigraphy and (3) Magnetic Resonance Imaging. All three tests are safe, easy to perform~     and non-invasive (i.e. do not involve inserting catheters through the nose and into the~     stomach or taking blood). The results should provide more useful information to doctors~     looking after patients with dyspeptic symptoms.~      This study will compare test results from healthy volunteers, with patients attending clinic~     for investigation of dyspeptic symptoms. The aim is to document abnormal function of the~     stomach and intestines and to identify the causes of dyspeptic symptoms after a meal.~   "
3804|NCT03007420|"~     Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury,~     possibly generated by a number of stressors to the trigeminovascular and cervical plexus~     networks, including inflammation of the high cervical facet joints, traumatic cranial~     neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for~     PTH management except for conservative modalities, such as cognitive rest, physical therapy,~     and neuropathic pain medications, all of which have minimal evidence to support them.~      The investigators propose a randomized, controlled, clinical trial and prospective follow-up~     study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and~     cervical medial branch block (CMBB) in the management of PTH.~      Adolescents and young adults (14-35 years of age) will be recruited from Boston Children's~     Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and~     Headache clinics.~   "
3805|NCT03007407|"~     This study is being done to look at the safety and response to the combination of two~     investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for~     patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and~     durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune~     system to destroy the cancer cells.~      In order to learn more about certain characteristics of colorectal cancer tumors, this study~     includes special research tests using samples from diagnostic tumors, fresh tumor samples~     from an area where the cancer has spread, and blood samples.~   "
3806|NCT03007394|"~     The objective of this study is to evaluate the efficacy and safety of lorcaserin in the~     treatment of cocaine use disorder.~   "
3807|NCT03007381|"~     Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been~     shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and~     obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and~     central nervous system depression post operatively, while still providing adequate pain~     control for patients. Patients undergoing abdominally based microsurgical breast~     reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be~     safely discharged from hospital sooner than their counterparts receiving standard of care.~      Research Question: In adult women post-mastectomy, undergoing abdominally based~     microsurgical breast reconstruction, does a postoperative regimen of intravenous ketorolac~     tromethamine, in addition to standard of care, reduce the length of postoperative hospital~     stay compared with an intravenous sham saline regimen?~      Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm,~     parallel group, superiority, randomized, and double blinded, controlled trial.~      Population: The study population includes all females >18 years old post mastectomy~     consenting to abdominally based microsurgical breast reconstruction.~      Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours~     postoperatively for 72 hours. The comparator will be a sham intravenous administration of~     normal saline.~      Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes~     include visual analog scale for pain, breakthrough narcotic consumption, surgical drain~     outputs, hematoma, and other complications.~      Sample Size: Available data provided estimates for average length of hospital stay and~     standard deviation. A minimally clinically significant difference of 1 day was decided on~     due to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account~     for attrition and efficiency losses, a total of 50 patients (25 per group) will be required~     for this study.~   "
3808|NCT03007368|"~     As populations become urbanized in Africa, the change to a more Westernized diet has been~     associated with rise in obesity and related metabolic syndrome diseases. The current study~     shows that in the West African Sahel, these replacement starchy staple foods have fast~     gastric emptying compared to traditional sorghum and millet foods; and implies that the~     latter could be beneficial in lowering glycemic response, providing energy from a meal over~     a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and~     millet foods could be useful to improve their image in West African cities to increase their~     consumption and to improve markets for local smallholder farmers.~   "
3810|NCT03007342|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult~     patient with symptomatic apical periodontitis.~   "
3811|NCT03007329|"~     SGLT2 antagonists and GLP1 agonists are used since a relatively short period as second line~     therapy if indicated and are well tolerated by patients featuring low risk of hypoglycaemia~     in comparison to insulin or other oral glucose lowering drug. This new treatment options~     offer an effective modality to lower blood glucose, if first line therapeutics fail.~     According to national and international guidelines combination of oral glucose lowering~     drugs is possible in multiple ways, but is currently not recommended for GLP1 agonists and~     SGLT2 inhibitors yet, as evidence and supporting studies are missing proving efficacy and~     safety]. Thus studies under standardized conditions are urgently needed to answer these~     unsolved questions.~      First results of a combination of a SGLT2 Inhibitor and a GLP1 agonist demonstrated huge~     potential regarding glucose and weight reduction and safety issues. However, further studies~     are necessary to elucidate potential mechanisms of combination therapy with SGLT2 inhibitors~     and GLP1 agonists and its effect on weight loss, glucose control, effects on incretins and~     adipokines, as well as further effects on ectopic lipid accumulation in liver and other~     tissues as myocard or pancreas in humans.~      As both monotherapies have effects on weight and metabolism, changes in abdominal,~     subcutaneous, hepatic, myocardial or pancreatic lipid content might be speculated and are~     focus of interest in this study. Recently GLP1 agonists were shown to have effects on~     hepatic lipid reduction in humans with diabetes.~      Hepatic lipid content and steatosis hepatis are widely discussed to have major effects on~     progression of diabetes and cardiovascular disease. Thus reduction of lipid accumulation in~     hepatic tissue might have an effect on diabetes progression.~      Also higher myocardial lipid accumulation is seen in diabetic patients probably partly~     responsible for higher cardiovascular risk in diabetics. So far results combining these two~     drug classes show less weight loss as might have been expected using monotherapy, so that~     further investigation will definitely shed light on combination of therapeutic concepts.~      Facing a multiple of positive side effects (weight loss, blood pressure lowering, potential~     protective cardiac effects) using a combination of SGLT2 and GLP1 seems to be a promising~     therapeutic option in diabetic subjects.~   "
3812|NCT03007316|"~     An array of soft tissue augmentation techniques have been employed concomitant to implant~     placement, as free connective tissue grafts or pedicle grafts for keratinized tissue~     thickening in attempt not only to augment the soft tissue for better resistance to~     inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.~      Results obtained from the literature were controversial regarding the need of soft tissue~     augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature~     was found, that monitored the ridge alterations following implant placement.~      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and~     buccal bone resorption during the process of remodeling in a measurable way.~   "
3813|NCT03007303|"~     This study investigates the relationship of circulating microRNA-30e and schizophrenia, and~     shows the relevance of the aberrant microRNA-30e expression in plasma with the variation~     disease status.~   "
3814|NCT03007290|"~     Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with~     colistin~   "
3815|NCT03007277|"~     The PANJO study aims to evaluate, within the French public health services, the impact of a~     home visitors training on parent-child attachment, families outcomes, use of services and~     child maltreatment indicators.~   "
3816|NCT03007264|"~     In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin~     of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial~     effect will be investigated as well. The investigators expect this treatment to have a good~     antimicrobial effect with acceptable, transient skin sensations.~   "
3817|NCT03007251|"~     The purpose of this study is to investigate different effects of Eurythmy Therapy on~     psychological and physiological parameters of circulation and thermoregulation~   "
3818|NCT03007238|"~     This phase II trial studies efficacy of extracorporeal photopheresis and low dose~     aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease~     (cGVHD) that does not respond to upfront treatment with steroids. In graft-vs-host disease,~     patients have a small quantity of a white blood cell called T regulatory cells or T-reg~     cells that helps to control the immune system. Extracorporeal photopheresis is a procedure~     where patient's blood is removed and treated with ultraviolet light and drugs that become~     active when exposed to light. The treated blood is then returned to the patient and may be~     effective in increasing T-reg cells in patients with cGVHD. Aldesleukin increases the~     activity and growth of white blood cells, and it has shown to enhance T-reg cells in~     patients with cGVHD and may be effective improving GVHD symptoms.~   "
3819|NCT03007225|"~     This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with~     chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of~     hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after~     embolization~   "
3820|NCT03007212|"~     Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess~     the outcomes after TACE in patients with branch PVT regarding Child classification,~     radiological response and 1 year survival.~   "
3821|NCT03007199|"~     The AGNES case-control set consists of individuals with a first acute ST-elevation~     myocardial infarction. AGNES cases have ECG- registered ventricular fibrillation occurring~     before reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES~     controls are individuals with a first acute ST-elevation myocardial infarction but without~     ventricular fibrillation. All cases and controls are recruited at seven heart centers in The~     Netherlands. The investigators' exclude individuals with an actual non-ST-elevation~     myocardial infarction, prior myocardial infarction, congenital heart defects, known~     structural heart disease, severe comorbidity, electrolyte disturbances, trauma at~     presentation, recent surgery, previous coronary artery bypass graft or use of class I and~     III antiarrhythmic drugs. Individuals who develop ventricular fibrillation during or after~     percutaneous coronary intervention are not eligible. Furthermore, because early reperfusion~     limits the opportunity of developing ventricular fibrillation, potential control subjects~     undergoing percutaneous coronary intervention within 2 h after onset of myocardial ischemia~     symptoms were not included. This time interval is based on the observation that >90% of~     cases develop ventricular fibrillation within 2 h after onset of the complaint of symptoms.~   "
3822|NCT03007186|"~     This study aims to show whether the hyperglycaemic phases following a treatment with~     glucocorticoids, as well as blood measurements correlated to high blood glucose levels and~     insulin resistance, vary significantly between patients with and without gestational~     diabetes mellitus.~   "
3837|NCT03006991|"~     This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective~     concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics~     model to provide reference for individual administration on JIA pediatric patients.~   "
3838|NCT03006978|"~     The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of~     the TearCare™ System compared to standardized warm compress therapy for the application of~     controlled, localized heat therapy in adult patients with dry eye syndrome.~   "
3823|NCT03007173|"~     Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep~     navels and poor personal hygiene; however, it can be seen in females. UPS could easily be~     misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis~     is easy to establish with physical examination and a detailed history. Treatment is~     generally depending on the severity of the disease, ranging from good personal hygiene to~     surgical excision of umbilical complex. The treatment of choice for chronic, intermittent~     cases is surgical removal of the affected portion; paying special attention to cosmetic~     appearance especially in female patients. In this report, we present two cases of UPS, one~     in a man and one in a woman with the explanation of its etiopathogenesis and surgical~     treatment.~   "
3824|NCT03007160|"~     Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis~     formation or recurrence.~   "
3825|NCT03007147|"~     This randomized phase III trial studies how well imatinib mesylate and combination~     chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive~     acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving imatinib mesylate and~     combination chemotherapy may work better in treating patients with Philadelphia chromosome~     positive acute lymphoblastic leukemia.~   "
3826|NCT03007134|"~     The purpose of this study is to (1) compare a technically improved assay with an existing~     assay used to measure serum anti-GM-CSF antibodies in stored serum samples previously~     obtained from patients diagnosed with either primary, secondary, congenital or idiopathic~     pulmonary alveolar proteinosis (PAP), other chronic diseases or disease-free, healthy~     individuals; (2) determine the prevalence and levels of anti-GM-CSF autoantibodies and (3)~     define the breadth of the autoimmune antibody responses in primary PAP patients from the~     United States, Japan, Australia, and Europe using previously collected serum samples; and~     (4) using a chart review approach, compare the clinical, radiologic and laboratory features~     of primary PAP patients to determine if differences exist among patients in these globally~     geographically distributed regions.~   "
3827|NCT03007121|"~     The purpose of this study is to determine which postoperative analgesia is optimal after~     colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural~     analgesia and standard systemic analgesia. All patients will have the possibility to~     administer themselves intravenous morphine as needed.~   "
3828|NCT03007108|"~     The aim of this study is to establish normal values of thrombin generation assay parameters~     in pediatrics, according to different age groups. The standardized thrombin generation assay~     Genesia™ will be used. Different age groups of healthy children will be recruited :~     neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15~     years old. Adults values will be obtained (healthy adults > 18 years old).~   "
3829|NCT03007095|"~     The study aims at investigating social cognition outcomes of children born prematurely.~     Social cognition can be briefly defined as a process which underlines people's social and~     emotional behaviors. There are behavioral and cognitive evidences indicating that preterm~     children have executive dysfunctions. Executive functions refer to multiple cognitive~     processes that contribute to human higher order abilities, such as purposeful and~     future-orientated behavior. The literature regarding development of term born children~     indicates that executive functions are linked to the emergence of social cognition. Then,~     the investigators asked if children born prematurely, as they commonly present executive~     dysfunctions, would show an atypical development of social cognition. Additionally, as it~     has been shown that parental anxiety is a key factor of preterm children development, the~     investigators assumed that it should play a role in social cognition outcomes.~   "
3830|NCT03007082|"~     This is a multicenter, prospective registry clinical study to evaluate the real-world~     efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE~     device on the basis of standardised medical treatment.~   "
3831|NCT03007069|"~     Using growth factors obtained from patient's venous blood mixed with particulate autogenous~     bone the study compares bone gain by implant with gold standards.~   "
3832|NCT03007056|"~     The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,~     oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also~     evaluated.~   "
3833|NCT03007043|"~     To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as~     well as other, less studied, gonadotropin polymorphisms between ovarian response groups,~     following ovarian stimulation~   "
3834|NCT03007030|"~     The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can~     help to control mesothelioma. The safety of this drug will also be studied.~   "
3835|NCT03007017|"~     Despite many efforts to increase the size of the donor pool, there is a large and growing~     disparity between the number of donor kidneys available for transplantation and the number~     of patients on the transplant waiting list. Increasing the quality of currently available~     donor kidneys would potentially improve the longevity of deceased donor kidney transplants~     by years, thus increasing the rate of transplantation patients on the kidney transplant~     waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays~     and lower total hospital charges. By innovating the organ donation process, such that~     deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than~     after, it may be possible to improve the quality of the kidney before transplantation,~     resulting in improved function after transplantation and increased longevity of these~     transplanted kidneys. Further, this improved kidney quality is highly likely to translate to~     reduced need for renal dialysis and other high-cost interventions, yielding lower total~     hospital charges. In this study we will test the hypothesis that, through a cost-free~     technical innovation, the quality of deceased donor kidneys could be improved significantly,~     saving thousands more lives per year and reducing total health care expenditures on renal~     transplantation.~   "
3836|NCT03007004|"~     Efficacy and safety of local infusion of botulinum toxin type B in patients with systemic~     sclerosis (SSc) with digital ulcer is evaluated by a randomized, double-blind study.~   "
3839|NCT03006965|"~     The purpose of this study is to describe the pharmacokinetic profile of patients with~     hemophilia A in prophylaxis in Spain using myPKFit®~   "
3843|NCT03006913|"~     Using mixed methods, investigators will conduct a multicenter partially randomized~     preference noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking~     patients assigned by (1) patients´ preference or (2) randomization to three counseling~     modes: (a) in-person; (b) phone; or (c) video conference. A total of 600 patients will~     complete counseling and 540 will complete the final survey. Baseline and post-counseling~     surveys will use validated measures (adapted for literacy and language) of study outcomes.~     All counseling sessions will be audio-taped. A sample of 90 tapes will be analyzed for~     counseling content and to identify 30 participants for in-depth interviews and analysis~     triangulating all forms of data. Genetic counselors will be interviewed in depth to elicit~     their perceptions of the strengths and limitations of each counseling mode.~   "
3844|NCT03006900|"~     Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to~     the more traditional exercise programs. Although somewhat limited, previous research has~     suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded,~     randomized controlled study has one intervention group (Pilates and massage therapy) and one~     control group (massage therapy only). The primary outcome of interest is the change in~     walking ability between groups. Secondary outcomes include other measures of physical~     performance and quality of life.~   "
3845|NCT03006887|"~     This is an open-label Phase 1b study designed to confirm the tolerability and safety of~     lenvatinib in combination with pembrolizumab in participants with selected solid tumors~     (non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial~     carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma~     [excluding uveal melanoma]).~   "
3846|NCT03006874|"~     The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared~     to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8.~   "
3847|NCT03006861|"~     Creatine is a nutritional supplement that is often ingested to improve exercise performance.~     The advent of a new product that is applied to the skin overlying muscle offers potential~     benefit, if the creatine can be targeted to specific muscles. The investigators are testing~     a novel creatine cream to determine the effects on human muscular performance. The~     investigators are assessing whether 7 days of topical creatine application is additive to~     orally-ingested creatine for improving muscular power (determined by knee extension).~   "
3848|NCT03006848|"~     This clinical trial seeks to determine if avelumab will be effective in facilitating removal~     of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab~     will be evaluated using dosing that has previously been determined in adult studies.~      Primary Objectives:~        -  To estimate the response rate to 4 cycles of avelumab in patients with recurrent or~          progressive osteosarcoma.~        -  To estimate the 16-week progression free survival of patients with recurrent or~          progressive osteosarcoma after treatment with avelumab.~      Secondary Objective:~        -  To describe the toxicities associated with the administration of avelumab in patients~          with recurrent or progressive osteosarcoma.~      Exploratory Objectives:~        -  To explore factors associated with response in patients treated with avelumab after~          recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression).~        -  To measure parameters of immune activation including subsets of peripheral blood~          mononuclear cells (PBMCs) and serum markers of immune activation.~        -  To evaluate the role of T-cells in immune checkpoint blockade via measures of cell~          proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and~          epigenetic programming.~   "
3849|NCT03006835|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological~     study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary~     intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following~     treatment groups:~      Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.~      Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.~      Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.~      Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.~      Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the~     loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram.~     Documentation of major adverse cardiac events (death, myocardial infarction, stroke,~     revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other~     adverse events)will be performed until Day 30.~   "
3850|NCT03006822|"~     Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high~     prevalent and may influence the neck and shoulder conditions. The pressure release is one of~     the most recommended manual therapy techniques.~      Objective: To determine the time effect of the pressure release technique application in the~     latent MTrPs of the levator scapulae muscle.~      Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.~      The manual technique than us apply, be sustained digital pressure with thumbs or with the~     2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling~     of tissue resistance (barrier), as decreases, adds more pressure. different times of~     sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a~     control), 60 (group 2) and 90 seconds (group 3) shall apply.~   "
3851|NCT03006809|"~     This is a prospective unblinded, randomized trial for the use of Fecal Microbiota~     Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or~     without antibiotic pretreatment.~   "
3852|NCT03006796|"~     This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared~     with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial~     hypertension and obesity.~   "
3853|NCT03006783|"~     A retrospective and cross-sectional analysis of standard of care for facial paralysis~     involving the cross-face nerve graft in the past 20 years.~        -  Imagery analysis~        -  Questionnaires~   "
3854|NCT03006770|"~     This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III~     study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular~     Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with~     Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.~   "
3856|NCT03006744|"~     The promotion of language and communicative development in the early years is extremely~     important. Children who enter school with good language skills have better educational and~     economic success. This study is part of a large project across Liverpool, Manchester and~     Sheffield Universities to determine how shared reading promotes child language development,~     and use this knowledge to make it an effective language boosting tool for children across~     the whole socio-economic spectrum. The overall project includes:~        -  observational studies to identify what language boosting behaviours are responsible for~          shared reading's effectiveness, and how parents from different socio-economic groups~          use these behaviours during shared reading;~        -  intervention studies to evaluate packages designed to train parents in the use of~          specific language boosting behaviours during reading;~        -  a qualitative exploration of the reasons people may not read with their children.~      This study will provide training to parents on how to develop their children's attention to~     the features of words while reading books with them. The research questions are:~      i) Is specific training focused on the sound properties of words during shared reading more~     effective at developing children's phonological awareness and language than general advice~     on the importance of reading with children? ii) Do children with speech sound disorder and~     typically developing children respond differently to intervention? iii) To what extent are~     differences in training implementation and effects explained by socio-economic status?~      Our participants will be parents and their children, aged 30-54 months, with a diagnosis of~     speech sound disorder. They will be recruited via speech and language therapy services in~     the North West. Data collection will be carried out by the research team in participants'~     homes, taking 3-4 hours in total over 2-3 appointments. The sessions will be audio-recorded;~     parents will complete questionnaires, and children's language and speech will be assessed~     with standardised and in-house tests.~   "
3857|NCT03006731|"~     The purpose of this study is to compare the effects of an exercise training strategy called~     high-intensity interval training (HIIT) to moderate intensity continuous exercise (MICE), on~     walking function and cardiovascular fitness in stroke patients. Hypothesis: HIIT will result~     in significantly greater benefit to fitness and mobility than MICE.~   "
3858|NCT03006718|"~     The overall goal of the project is to reduce pain-related, 30-day readmission rates for~     sickle cell disease (SCD) patients. The investigators want to see if a mobile phone~     application (app) can help decrease the need for repeat admission to the hospital because of~     sickle cell pain.~   "
3859|NCT03006705|"~     The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant~     chemotherapy with ONO-4538 in combination with tegafur-gimeracil-oteracil potassium (S-1~     therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in~     combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including~     esophagogastric junction cancer) after D2 or more extensive lymph node dissection.~   "
3860|NCT03006692|"~     In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas~     testing is present since 2014. This study will determine if a prehospital arterial blood gas~     helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be~     determined if the doctors find this device helpful in assessing and treating patients with~     affected consciousness.~   "
3861|NCT03006679|"~     The purpose of this study is to determine the efficacy, safety, tolerability, and~     pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to~     14 days in the treatment of hospitalized adults who meet clinical, radiographic, and~     microbiological criteria for hospital-acquired bacterial pneumonia (HABP) or~     ventilator-associated bacterial pneumonia (VABP).~   "
3862|NCT03006666|"~     Cluster randomized trial to test the impact of peer health coaches on prediabetic patients.~     This study will test a scalable model of peer health coaching to address the millions of~     patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to~     promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.~   "
3863|NCT03006653|"~     Understanding Daily Fluctuations in Self-Regulation, also known as the Digital Marshmallow~     Test (DMT), is a collaboration by Northwell Health, Cornell Tech, and Sage Bionetworks.~     Funded by the Robert Wood Johnson Foundation, this is a pioneering study to advance the~     science in identifying and helping individuals who act on short-term temptations, despite~     long-term consequences. Using Apple's ResearchKit(™) and Android's ResearchStack~     applications, the Digital Marshmallow Test will leverage the powerful capabilities of the~     smartphone to examine impulsivity using a range of game-like tasks and sensor capabilities~     within the mobile phone. Across studies, more impulsive individuals are significantly more~     likely to suffer from obesity, Type II Diabetes, substance abuse, gambling problems,~     suicidal behaviors, and increased criminality among many other problems. Early self-report~     studies reveal a relationship between the inability to delay gratification and different~     patterns of mobile phone use. This will be the first study to develop non-invasive mobile~     methods to identify and help those at greatest risk for impulsive responding before serious~     problems occur.~   "
3864|NCT03006640|"~     Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,~     difficult sampling and problems encountered with noninvasive blood pressure monitoring makes~     arterial cannulation an essential skill in many situations like surgeries or trans-radial~     procedures for coronary or carotid interventions.~      Radial artery has been preferred over other sites for arterial cannulation due to low~     incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this~     study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation~     aiming to decrease insertion time, increase success rate and decrease related complications~   "
3865|NCT03006627|"~     Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences~     in the opioid analgesia have been reported and investigated in human subjects and animal~     models In this study, effects of sex difference on response to opioid analgesics after~     abdominal surgeries will be assessed regarding; analgesic duration (primary variable),~     frequency of analgesic requirement, total opioid consumption, Opioid related complications~     (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal~     motility).~   "
3866|NCT03006614|"~     This study aims to explore new PERS prediction model can improve the pathological complete~     response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.~   "
3867|NCT03006601|"~     This study aims to determine the treatment effect of vision therapy on myopic children by~     assessment of accommodative function before and after therapy.~   "
3868|NCT03006588|"~     EUS-FNA for RPLN in NPC~   "
3869|NCT03006575|"~     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy~     after split irradiation with concurrent chemotherapy in locoregional recurrence of non-small~     cell lung cancer after surgical resection~   "
3870|NCT03006562|"~     The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis~     (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of~     IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy~     (RP).~   "
3871|NCT03006549|"~     Despite increasing interest in emergency manuals (EMs), relatively little is known about~     their effectiveness and limitations in the perioperative setting. Prior studies have been~     limited in that they evaluated EMs using crises that were tailor-made to match one of their~     chapters, and there has been minimal participation by attending surgeons and other~     experienced personnel. The Investigators' preliminary experience suggests less-than-expected~     EM use and suboptimal usage, which may be due to the simulation scenario falling halfway~     between two different chapters of the EM, raising the question of whether limitations were~     due to the EM content, team dynamics, or inadequate training in the EM use. In this~     randomized, prospective, two-center simulation-based study, the investigators utilize~     clinical scenarios specifically designed to observe the patterns of use and to test the~     limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen,~     clinical performance in situations that do not exactly match a specific chapter of that EM,~     and that EM usage patterns will identify both strengths and limitations of the tools and its~     implementation. The participating healthcare providers consisting of experienced surgeons,~     anesthesiologists, and nurses will be randomized into four experimental groups, each exposed~     to either a specific or non-specific simulation scenario, along with or without the~     availability of the EM. The major experimental endpoint will be how many critical actions~     each team performs, scored as the percentage of actions taken from a pre-determined list.~     The goal of this study is to improve EM content and use by understanding its limitations~     during interprofessional team-training simulations and to study whether EMs enhance or~     detract from clinical performance. This is especially a concern in situations that do not~     exactly match a specific chapter of the EM, such as cases that are vague and represent~     multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is~     to strengthen patient safety by providing guidance for improving EM content, use, and~     training protocols.~   "
3872|NCT03006536|"~     The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function~     and triggers angiogenesis through induction of local growth factors and endothelial nitric~     oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies~     investigating the clinical effects have been encouraging. Meanwhile, randomized trials have~     shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed~     statistically greater improvements in the Erectile Function Domain of the International~     Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment~     (p=0.032).~   "
3873|NCT03006523|"~     To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It~     is hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher~     clinical pregnancy rates will be achieved by promoting higher sperm densities in the~     fallopian tubes at the time of ovulation by decreasing the amount of sperm cells lost during~     preparation and handling.~   "
3874|NCT03006510|"~     Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of~     inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased~     morbidity and mortality (ie falls and cardiovascular or cerebral events).~      The group at Washington University (WSL) developed a predictive hypoglycemia risk score.~     Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral~     diabetic therapy, they identified patients at high risk for hypoglycemia and then provided~     in-person education to the providers of these patients. This resulted in a 68% reduction in~     severe hypoglycemia (blood glucose < 40 mg/dL). This approach required significant personnel~     hours and is difficult to replicate in other systems.~      We will implement an EHR-based intervention at UCSF to predict which patients are at high~     risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real~     time, all adult (non OB) patients with a glucose < 90, and a high risk of future~     hypoglycemia (based on the WSL formula) will be identified. Patients will be randomly~     assigned to intervention or no intervention (current standard care). The intervention will~     consist of an automated provider alert with recommendations on what adjustments could be~     made to avoid a potentially serious hypoglycemic event.~      The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2)~     monitor the changes made by providers as a result of alerts in order to study provider~     behavior and identify future areas of intervention, and 3) provider satisfaction with the~     alert system.~   "
3875|NCT03006497|"~     The aim of this study is to investigate the efficiency of an exercise program based on~     principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic~     patients.~   "
3876|NCT03006484|"~     Little is known about the long-term neurological outcomes after in-hospital cardiac arrest~     (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence~     rates of survivors with poor neurological status. Currently, withdrawal of care in comatose~     patients after cardiac arrest is strongly forbidden by law in Korea. However, a new~     legislation on allowing withdrawal of care will come into effect since early 2018 in Korea.~     The investigators aim to determine 1) long-term neurological outcomes in patients who~     developed IHCA, 2) whether early neurological status can predict late neurological status~     after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes~     will change since implementation of new legislation on withdrawal of care.~   "
3877|NCT03006471|"~     Prediabetes is defined as an intermediate metabolic state that leads to the development of~     type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify~     patients who are at risk of developing hypertension (AH), in both pathologies the~     abnormalities in the variation of blood pressure (BP) has been related to organ damage, its~     evaluation is performed by ambulatory blood pressure monitoring (ABPM).~      Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter~     type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of~     glucose through the urine, in the way that glucose blood. Another reported effects is the~     decrease on BP, so it would be interesting to evaluate this effects in patients with~     prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent~     progression to DM2 and HT, respectively.~      The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood~     pressure in patients with prediabetes and prehypertension without pharmacological treatment.~      The investigators hypothesis is that the administration of dapagliflozin decreases~     variability of blood pressure in patients with prediabetes and prehypertension without~     pharmacological treatment.~   "
3878|NCT03006445|"~     The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981~     administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by~     the method of multicenter, open label and ascending dose regimen.~   "
3897|NCT03006198|"~     The objective of this study is to explore and describe the disease characteristics,~     treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis,~     psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with~     REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa,~     the Middle East, and Western Asia.~   "
3879|NCT03006432|"~     Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from~     cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a~     cure. The vast majority of patients, however, present with advanced disease from the outset~     (locally advanced or metastatic) or recurrent after resection of a localised form.~      For metastatic or locally advanced stages of gastric or gastro-oesophageal junction~     adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with~     monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient~     survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered~     as one of the first-line chemotherapy treatment standards.~      The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it~     possible to improve the tumour response rate, the time to tumour progression and overall~     survival in a randomised phase III trial. This improvement in treatment efficacy was~     achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including~     diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a~     therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical~     practice due to its high toxicity.~      Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an~     efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common~     in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus~     5FU-cisplatin was associated with a non-significant improvement in median progression free~     survival rates, and overall survival.~      All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better~     tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than~     5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of~     development of chemotherapy protocols for metastatic gastric cancer, the question therefore~     arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and~     also tolerance.~      In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in~     advanced gastric cancer, but with progression-free survival and median survival rates that~     are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2~     every 2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results~     in phase II studies in terms of efficacy and tolerability, and these are worth confirming~     through a phase III randomised trial. In fact, if these results are confirmed in phase III,~     TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while~     limiting toxicity and preserving patients' quality of life, and could become the reference~     treatment to accompany the targeted therapies currently being developed for this disease.~      The primary objective of this randomised phase III trial is to compare the progression-free~     survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with~     5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or~     oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the~     tumour response rate, toxicity, quality of life and the therapeutic index, defined as the~     ratio between the median progression-free survival and the febrile neutropenia rate.~   "
3880|NCT03006419|"~     Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy~     (delayed graft function, slow graft function, biopsy proven acute rejection episodes,~     infections, hospitalizations, adverse events, graft loss and death) than Basiliximab~     induction~   "
3881|NCT03006406|"~     Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which~     can down-regulate pituitary function causing a temporary low estrogen state. Since~     endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control~     the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for~     adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a~     for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the~     controls with normal uterus. Thus, the aim of this study is to compare the clinical~     pregnancy rate in patients treated with GnRH-a for 1, or 2 months.~   "
3882|NCT03006393|"~     The main purpose of this study is to examine the effects of infliximab on measures related~     to depression symptoms. Infliximab is also known by its brand name Remicade. Infliximab, or~     Remicade, is given to by an intravenous (IV) needle and is currently used to treat~     rheumatoid arthritis and Crohn's disease. Infliximab is thought to help these conditions~     because it reduces inflammation in the body. Infliximab (Remicade) reduces inflammation by~     blocking a chemical in the body called tumor necrosis factor (TNF)-alpha. This chemical~     produces inflammation. Inflammatory chemicals in the body like TNF-alpha appear to be~     increased in some people with major depression. Researchers believe that a drug like~     infliximab, which blocks TNF-alpha, may be helpful in treating depression.~      This is a double-blind, placebo-controlled study in which participants will be randomized to~     receive one infusion of infliximab or placebo. The study will assess neuroimaging measures~     of corticostriatal circuitry before and after a placebo-controlled pharmacologic blockade of~     inflammation in 80 depressed patients.~   "
3883|NCT03006380|"~     Randomized controlled study to assess the efficacy and safety of the timing of~     administration of prophylactic oxytocin via intramuscular route (before compared to after~     placental delivery) on blood loss in vaginal delivery.~   "
3884|NCT03006367|"~     This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of~     NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.~   "
3885|NCT03006354|"~     In this prospective, randomised clinical trial the investigators aim to assess if nasal high~     frequency oscillatory ventilation (nHFOV) could be used as the primary modality of~     respiratory support in late preterm and term infants with transient tachypnea of the newborn~     requiring non-invasive ventilation.~   "
3886|NCT03006341|"~     The objectives of this study are, first, to identify select clinical covariates from~     electronic medical records (EMR) that might be associated with initiation of oral~     anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial~     fibrillation (NVAF) at risk for stroke; second, to quantify the association between~     EMR-based clinical characteristics and patterns of insurance claims; third, to assess the~     potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and~     safety studies based on administrative claims databases.~   "
3887|NCT03006328|"~     The GEM intervention leverages the patient-centered medical home model by using the GEM tool~     to provide individually tailored, patient-centered care at the time of the primary care~     visit, promote standardized weight management counseling by health coaches and primary team~     members, coordinate care between teams and other weight management service~     providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the~     provider and primary care team about patients' weight management-related goals, progress,~     and care.~   "
3888|NCT03006315|"~     Enrolled participants health status will be tracked by using a mobile health-monitoring~     device while undergoing chemotherapy for multiple myeloma.~   "
3889|NCT03006302|"~     This study will enroll patients who have metastatic pancreatic cancer and have progressed on~     prior chemotherapy.~      Half of participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX~     pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207 (Arm A), while the other half~     will receive epacadostat/pembrolizumab/CRS-207 (Arm B).~      The primary objectives of this study are to determine the recommended dose of epacadostat in~     this combination and assess survival of subjects in both treatment groups.~   "
3890|NCT03006289|"~     The purpose of this study is to investigate the association between metabolic syndrome (MS),~     body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen~     for the risk factors that affect the incidence of thyroid cancer.~   "
3891|NCT03006276|"~     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura,~     being conducted at multiple centers in the United States.~   "
3892|NCT03006263|"~     The purpose of this study is to explore clinical outcomes of totally laparoscopic versus~     laparoscopy assisted total gastrectomy for gastric cancer.~   "
3899|NCT03006172|"~     This is an open-label, multicenter, Phase I study designed to evaluate the safety,~     tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in~     participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate~     3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and~     in combination with standard-of-care endocrine and targeted therapies for the treatment of~     locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal~     growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in~     two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II).~     Participants will be assigned to one of four regimens: GDC-0077 as a single agent (Arm A),~     GDC-0077 in combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with~     letrozole (Arm C), or GDC-0077 in combination with fulvestrant (Arm D).~   "
3900|NCT03006159|"~     This is a randomized, placebo-controlled, multiple dose escalation study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be~     conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be~     randomized in each cohort to receive the study drug or placebo.~   "
3901|NCT03006146|"~     Autoimmune PAP is a rare lung disease affecting less than 5,000 individuals in US with no~     FDA-approved pharmacologic therapy. Results from off-label use in case reports and~     clinical studies completed outside of the US indicate that inhaled rhGM-CSF may be a safe~     and effective thera-py for autoimmune PAP. Preliminary clinical trials of inhaled rhGM-CSF~     in autoimmune PAP patients show promising results, 62%-96% therapeutic response rate without~     any identifiable drug-related adverse effects in at least 73 autoimmune PAP patients.~     However, the pharmacokinetics (PK), pharmacodynamics (PD), optimal dose, and treatment~     duration to maximize efficacy are unknown.~      The goal is to begin to address these knowledge gaps for inhaled sargramostim for autoimmune~     PAP patients with a pilot safety and PK/PD study (TPSC-110). TPSC-110, PharmPAP, which is a~     self-controlled open-label, phase I study to evaluate the safety, PK, and PD of inhaled~     sargra-mostim in autoimmune PAP patients. These results will impact the field by 1)~     confirming existing published data, 2) monitoring the local effects of inhaled sargramostim~     in autoimmune PAP patients, 3) potentially demonstrating a safe starting dose for a later~     trial to evaluate the therapeutic efficacy of inhaled sargramostim for autoimmune PAP.~   "
3902|NCT03006133|"~     The protocol is to show the prevalence of bruxism among a group of Egyptian children~   "
3903|NCT03006120|"~     Bleeding complications after cardiac catheterization have been reviewed previously, but~     there are very few studies on retroperitoneal hematoma and appropriate treatment of patients~     is not well defined. For this reason, the investigators aimed to analyze the clinical~     manifestations of retroperitoneal hematomas in a single center using a case-control study~     design, to analyze the treatment procedure determinants and consequently to provide an~     updated and usable treatment algorithm.~   "
3904|NCT03006107|"~     to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative~     pain associated with endodontic procedures.~   "
3905|NCT03006094|"~     The aim of the present study is to investigate and report on the psychometric properties of~     a Greek version of the Chronic Pain Grade Questionnaire (CPGQ).~   "
3906|NCT03006081|"~     Retinal nonperfusion drives vision-threatening complications such as pathological~     neovascularization, which can lead to neovascular glaucoma, vitreous hemorrhage, or~     tractional retinal detachments and macular edema in diabetic retinopathy. Thus, decreasing~     nonperfusion area with aid of anti-VEGF agents might be a useful way to prevent~     deteriorating course of diabetic retinopathy. The main purpose of this study is to determine~     the efficacy of intravitreal aflibercept injection in improvement of retinal nonperfusion~     and identify associated factors in patients with nonproliferative diabetic retinopathy with~     moderate retinal nonperfusion.~   "
3907|NCT03006068|"~     This study is designed to evaluate the long-term safety and efficacy of ABT-494 in~     participants with ulcerative colitis (UC) who have not responded at the end of the induction~     period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the~     maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study~     M14-234.~   "
3908|NCT03006055|"~     The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE~     approved. Application data of CellCollector in China is not available now. The purpose of~     this clinical trial is to confirm the validation and safety of CellCollector in Chinese~     patients.~   "
3909|NCT03006042|"~     The transversus abdominis plane block (TAP block) is an effective method of postoperative~     pain management after cesarean section (C-section). Up to now, there are no data available~     about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the~     investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP~     block using BPV in parturients undergoing C-section and to report its effects on corrected~     QT interval.~   "
3910|NCT03006029|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended~     Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid~     malignancies.~   "
3911|NCT03006016|"~     Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the~     hiatal region during bariatric surgery. The doctors made a preliminary prospective study~     that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction~     resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on~     ultrasounds.~      The aim of this study is to determine whether a 4-week preoperative course with omega-3~     without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume~     and its fat content, rendering thus surgery easier.~      The primary end point is the reduction of the volume of the left liver lobe as measured by~     magnetic resonance imaging.~      Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver~     injuries during surgery, and duration of surgery, the evolution of liver tests as well as~     the correlation between preoperative MRI data and intraoperative liver biopsy for the~     quantification of liver steatosis.~      Study design: This is an interventional, prospective, multicentric, randomized, double~     blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to~     bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute~     Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients~     in 12 months.~      Study time schedule: At the time of the enrollment visit two visits are scheduled, the first~     before the beginning of the study and the last at the end. Surgery is scheduled no more than~     7 days after the end of the treatment. At time of these two visits a clinical examination is~     performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL~     cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive~     protein) and a MRI to evaluate the volume and the fat content of the liver. At time of~     surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is~     performed.~      The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a~     reduction in the volume of the left liver lobe of 20 %.~      Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results~     in a significant reduction of liver volume and steatosis before bariatric surgery, it may be~     recommended as a systematic preoperative treatment.~   "
3914|NCT03005977|"~     What test is most sensitive in identifying stress urinary incontinence in women with pelvic~     organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states~     that there is a difference between the sensitivity of UDS, pyridium pad test and cough~     stress tests, with UDS being the most sensitive and the gold standard in identifying SUI in~     patients with pelvic organ prolapse.~   "
3915|NCT03005964|"~     To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in~     the treatment of plaque psoriasis~   "
3916|NCT03005951|"~     The purpose of this study is to see what effect skipping breakfast versus consuming~     breakfast has on cognitive performance and the hormones responsible for glucose homeostasis~     in lean and obese adolescent males. The subjects will be tested on their ability to maintain~     attention when given several tasks called continuous temporal expectancy tasks (CTET) and~     electrophysiological signals using electroencephalogram (EEG) will be monitored. These two~     study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast~     intervention and B = no breakfast. There will be a washout period of 7 days in between study~     visits.~   "
3917|NCT03005938|"~     The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM)~     on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral~     Palsy.~      Effect of SM and imitation of the SM has to be compared in the double-blinded randomized~     clinical trial.~   "
3918|NCT03005925|"~     Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting~     nearly 0.4% of the general population. It is a real public health issue. International~     guidelines recommend strict control (remission or low disease activity) of the disease, to~     avoid joint destruction in order to reduce the functional impact of the disease in the long~     term and to improve the quality of life of the patients.~      This care is based on a close follow-up requiring regular visits with the specialist which~     represents an additional cost (transport, visits). In this context, tele-medicine is often~     proposed as a complementary approach in the management of these chronic patients.~      Thus, the investigators propose to study the interest of a connected device by comparing a~     group of patients using this Smartphone application, coupled with a hand dynamometer during~     the 6 months following initiation of a new DMARD.~   "
3919|NCT03005912|"~     Despite modern hearing aids such as cochlear implants, speech comprehension during telephone~     conversation is challenging for hearing-impaired patients. On the one hand, conventional~     telephones transmit a limited spectrum of the acoustic signal compared to a normal~     conversation. On the other hand, lip reading during a phone call is generally not possible.~     As a result, speech comprehension during a telephone conversation is reduced. In previous~     studies, the authors demonstrated an improved speech comprehension for hearing-impaired~     patients using voice-over internet protocol (VoIP) telephony (Skype) compared to~     conventional telephony.~      New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to~     the hearing device. As the direct transmission is expected to improve signal-to-noise ratio,~     speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4~     different scenarios: 1. conventional telephony without bluetooth device 2. conventional~     telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony~     with bluetooth device~   "
3920|NCT03005899|"~     This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the~     SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.~   "
3921|NCT03005886|"~     The aim of this study was to evaluate the effects of periodontal treatment on gingival~     crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1)~     in chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to~     systemically healthy CP patients. The investigators' hypothesized that severe CP may play a~     role in initiating or exacerbating MI and there is an increased risk for AMI among~     systemically healthy persons affected with severe CP.~   "
3922|NCT03005873|"~     This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding~     Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of~     the knee.~   "
3923|NCT03005860|"~     Surgery, perioperative stress, anaesthetics and analgesics may modulate the~     immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance~     between immunity & carcinogenesis. This may lead to escape of cancer cells and tilt the~     scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have~     been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a~     favorable profile and inhibits cancer cell activity. Determining cancer-protective role of~     TIVA with propofol presents an exciting window of opportunity that has potential to improve~     outcomes in cancer patients undergoing resection surgery~   "
3924|NCT03005847|"~     Fermented papaya preparation has been reported to bind and neutralize reactive oxygen~     species as well as iron. Patients undergoing hemodialysis are generally on iron overload~     status due to their inability to use iron storage adequately. The aim of this study is to~     evaluate the effect of FPP on the iron status of these patients.~   "
3925|NCT03005834|"~     Because of the genetic and traditional commonalities between the underlying causes of~     atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients~     with atherosclerotic CVD may have a high incidence of cancers when compared with those with~     non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical~     outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara~     Health Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of~     improving healthy life expectancy in patients with CVD in our institute.~   "
3926|NCT03005821|"~     The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an~     add-on therapy while comparing with sham massage both on the basis of usual care for 0-6~     years old children with acute diarrhea.~   "
3927|NCT03005808|"~     Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall~     and the parietal peritoneum. The TAP block could advange the postoperative pain of~     Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s~     concentration to improve postoperative pain in Appendectomy in children. We propose a~     randomized trial that compares 3 groups children submitted Appendectomy in children between~     6 and 16 years. The control group has received no blockade, the other two groups have~     received TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.~   "
3930|NCT03005769|"~     This is an observational, retrospective, non-interventional study that will include~     schizophrenic patients who were initiated with aripiprazole once-monthly as per normal~     clinical practice at least 6 months before the data collection starts (inclusion visit), and~     is designed to evaluate demographic and clinical predictors of persistence with this~     treatment.~      Data from each patient will be collected after informed consent is signed (inclusion visit),~     and will include retrospective information from the start of aripiprazole once-monthly~     treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months~     after the index date). Data will be retrospectively collected from all visits occurring as~     per clinical practice (usually once monthly).~   "
3931|NCT03005756|"~     The needle guiding robot helps targeting of radiofrequency ablation needles by matching~     computed tomography images and patients' bodies. Actual insertion of needles will be~     performed by doctors. This study evaluates the safety and efficacy of needle targeting on~     patients with hepatocellular carcinoma.~   "
3932|NCT03005743|"~     Purpose of the study is to determine whether Image based brachytherapy is superior in terms~     of local control to Conventional radiograph based brachytherapy in locally advanced cervical~     cancers in a Phase III randomized setting.~   "
3933|NCT03005730|"~     Background: According to the International Association for the Study of Pain (IASP), the~     term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of~     which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles~     and neck on one or both sides as well as joint sounds, limited mandibular movements or~     mandibular deviation and difficulties chewing. Phototherapy, such as low level laser therapy~     (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment~     muscle pain. Thus, there is a need to investigate therapeutic resources that combine~     different wavelengths as well as different light sources (LLLT and LED) in the same~     apparatus.~      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,~     activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint~     mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine~     the cumulative effect 24 and 48 hours after a six session.~      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be~     carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous~     TMD. The participants will then be randomly allocated to two groups totaling 15 individuals~     per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one~     group will receive placebo therapy (0 Joules). The following assessment tools will be~     administered on four separate occasions (baseline and immediately after, 24 h after and 48 h~     after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,~     meter for range of movement, and electromyographic EMG analysis on the masseter and anterior~     temporal muscles.~      Discussion: The study will support the practice of evidence-based to the use of phototherapy~     in individuals with a myogenous TMD. Data will be published after the study is completed.~   "
3934|NCT03005717|"~     Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study~     to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on~     submental bulging due to subcutaneous fat. Approximately 150 participants of either gender~     who have a Moderate Bulge or Large Bulge in the submental fat (on Patient-Reported~     Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])~     will be recruited for this study.~   "
3935|NCT03005704|"~     The specific objective of this study is to investigate the potential for normal platelets to~     reverse the inhibition of platelet aggregation in patients treated with ticagrelor in~     combination with aspirin.~   "
3936|NCT03005691|"~     The purpose of this study is to determine whether the metabolite concentrations within the~     anterior cingulate cortex and periaqueductal gray matter predict the intensity and~     interference of neuropathic pain after the development of chronic whiplash syndrome.~   "
3937|NCT03005678|"~     A randomized controlled trial to compare for the efficacy and tolerability of denosumab and~     oral alendronate in the management of glucocorticoid induced osteoporosis~   "
3938|NCT03005665|"~     The purpose of the trial is to study the effect of acetazolamide administered via Ryle's~     tube on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.~   "
3939|NCT03005652|"~     The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate~     the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective~     Cognitive Decline (SCD), in comparison to an active comparison condition.~      It is increasingly recognized that most neuropathological processes start years before the~     onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target~     individuals in the earliest stages for intervention when neurodegeneration is still limited.~     Individuals clinically judged to have SCD, defined by subjectively experienced cognitive~     decline but normal performance on cognitive tests, are at increased risk for future~     cognitive decline and AD. These individuals with SCD currently have no established treatment~     options. Symptoms of anxiety have high prevalence in this population, and evidence from~     recent longitudinal research links anxiety with significantly accelerated cognitive decline~     in at risk individuals. Effectively reducing anxiety in this population may therefore not~     only relieve participants from burdensome symptoms, but may also slow cognitive decline and~     delay or prevent the onset of AD.~      The investigators chose to study the efficacy of a mindfulness-based intervention to reduce~     anxiety in this population because this type of intervention has been shown to reduce~     anxiety in a number of populations, including in older adults. Further, accumulating~     evidence indicates that intensive mindfulness training effectively down-regulates a number~     of other adverse psychological and biological risk factors for AD, such as stress,~     depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk~     factors. These findings are relevant to AD because approximately a third of AD cases~     worldwide might be attributable to potentially modifiable risk factors. In spite of the~     increased use of mindfulness-based interventions to treat clinical symptoms, these trials~     often suffer from the lack of an adequate comparison condition and lack of follow up to know~     whether initial benefits are maintained.~      SCD-WELL includes both an active comparison condition and a 16-week follow up assessment~     after the end of the intervention. SCD-WELL is a non-CTIMP European multicentre,~     observer-blinded, randomized, controlled, superiority trial with two parallel groups, which~     compares anxiety and additional behavioural and biological outcomes amongst people with SCD~     who receive mindfulness-based training and those who receive a health education comparison~     intervention. Outcomes will be measured at baseline, post-intervention and 16 weeks after~     the end of the intervention.~      160 older-adult patients diagnosed with SCD will be recruited to the study from memory~     clinics at four sites in Europe: London, UK; Cologne, Germany; Barcelona, Spain; Lyon,~     France where they will have sought help due to concern about their memory. Participants will~     be recruited in two waves over a maximum two-year period and will be provided with a~     participant information sheet, and asked to consider their participation. Should they wish~     to participate, and after a signed and dated Informed Consent Form has been obtained, a~     unique participant identification (ID) will be assigned to the participant.~      Behavioural assessments will take place at baseline, after the intervention, and 16 weeks~     after the end of the intervention. Because we believe that mindfulness-based training has~     the potential to affect a number of areas of life we will also look at changes in other~     areas of psycho-affective symptoms, social functioning, awareness, well being and quality of~     life, sleep quality, and cognition, after the intervention and 16 weeks after the end of the~     intervention. Validated neuropsychological tests and behavioural questionnaires were~     selected for their sensitivity to the domains listed above. These measures will be completed~     alone by the participant or in the presence of a psychometrist. Questionnaires will also be~     completed by partners at the three time points to coincide with assessments of participants.~      Blood samples will be taken at the memory clinic by certified phlebotomists at baseline,~     after the intervention and during follow-up to measure genetic markers of risk for AD as~     well as proteomic markers of stress and AD that may be affected by this intervention.~     Information will also be collected about the medical care of the participant.~      Trained facilitators will deliver both interventions. Both interventions follow a manual,~     are group-based, include at-home activities, and are 8 weeks in duration. Both interventions~     provide individuals with sustainable skills that remain beyond the intervention period.~   "
3940|NCT03005639|"~     Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma~      • To evaluate the overall radiological complete response rate in patients with stage IIIB/C~     melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib~   "
3941|NCT03005626|"~     We aim to measure the impact of a transition program in congenital cardiology in terms of~     health-related quality of life.~   "
3942|NCT03005613|"~     A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between~     Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.~   "
3943|NCT03005600|"~     Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common~     obstetric medical conditions which when undetected can cause significant adverse outcomes~     for the mother and the offspring. Diagnosis is typically made between 24-28 weeks of~     pregnancy using oral glucose tolerance test (OGTT). Therefore, some damage might have~     already happened prior to detection. Although universal screening is recommended by many~     guidelines, this is not uniformly followed across the world, partly because of doubts about~     cost-effectiveness. Only selective screening is followed based on presence of at least one~     of the high risk factors (age, BMI, previous history, etc). This strategy can miss up to 50%~     of GDM. In addition, no data exists in India and Kenya. In low and middle-income countries~     (LMICs), where majority live in rural settings, the major limitations are difficulty in~     conducting OGTT, which requires prompt access to laboratory facilities. Combining the~     clinical and easily analysable biochemical markers (composite risk score) could improve the~     prediction and if proven, could help to prevent the onset of GDM. Fasting glucose levels (at~     non-diabetes levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy~     can be a better marker as it can be done point-of-care and does not require patients to be~     in a fasting state. The overall objective of the proposed project is to develop a composite~     risk score to predict GDM in early pregnancy using a combination of easily identifiable risk~     factors such as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and~     Kenyans. The project will recruit pregnant women in early pregnancy from South India~     (n=3400) and Western Kenya (n=4000). Contribution of individual risk factors as well as the~     composite risk score on the risk of developing GDM will be assessed. Detailed health~     economic analyses will enable policy makers to make informed decision based on local data.~   "
3944|NCT03005587|"~     This a prospective observational study in Chronic Liver Disease patients admitted or seen in~     OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study~     will be conducted in a period of three months starting September 2016 in sample size of 80 .~     A detailed proforma including history and examination and routine blood investigations will~     be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and~     similar activities will be repeated at every visit.~   "
4327|NCT03000595|"~     This trial will be a single-blind, randomized, placebo-controlled, safety, tolerability and~     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment~     regimen when administered daily for up to 28 days to patients from 3 months to 65 years of~     age, with atopic dermatitis.~   "
3945|NCT03005574|"~     The purpose of this study is to determine if using a tablet computer, which is a very small,~     easy-to-carry computer, to practice thinking exercises at home will help improve your~     attention, memory, and problem solving abilities. All the participants will receive training~     in the thinking skills for work program. But in order to determine the effect of tablet use~     for home practice, half of the participants will be given a tablet to practice the thinking~     exercises at home. All participants will be receiving vocational rehabilitation and have a~     goal of getting a job.~   "
3946|NCT03005561|"~     In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to~     treat problems such as GH deficiency, chronic renal failure and Turner syndrome and~     Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate~     growth to close the gap in the average population and reach a final height is normal, while~     minimizing risks and costs.~      Noncompliance to treatment with GH is common; Other estimates are that one third to one half~     of patients do not comply with the provisions as require. This may result in linear growth~     depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and~     higher costs.~      Many studies have been devoted to locating factors make it difficult to adhere to their~     chronic diseases in children, including conditions that require treatment with GH.~      Pain is the primary cause for difficulties. In recent decades, many resources were devoted~     to research and development of ways of dealing with pain in all aspects.~      In order to implement all of the information collected, appropriate interventions medium~     should be found; In this study we intend to use the method of playback. Playback define that~     improvisation as a theater facilitator asks the audience to share moments, feelings and~     stories of his daily life, and a group of actors improvise their stories in front of the~     stage as a kind of play-back. Unlike hobbies such as sports or singing, the method allows~     not only to unload the tensions but also communication and collaboration. It is very~     reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.~      Assumption:~      Intervention of two playback meetings during the year will uncover the difficulties and~     engage ways of dealing with pain. That will reduce the difficulties caused by GH injections~     and improve compliance to treatment.~   "
3947|NCT03005548|"~     The primary objective of this single center, prospective, randomized, double blind clinical~     trial is to evaluate the effectiveness of anodal transcranial direct current stimulation~     (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine~     use for postoperative analgesia after thoracotomy. The intervention group will receive~     treatment with anodal tDCS, whereas the control group will receive sham stimulation.~   "
3948|NCT03005535|"~     This will be a randomized clinical trial carried out on subjects with suboptimal control of~     cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E~     vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9~   "
3949|NCT03005522|"~     An individual's quality of life can be seriously affected by the severity of dental pain.~     The emergency department is a common place to find those seeking relief from their dental~     pain- often times seeking removal of the affected tooth, dental anesthetic injections or~     oral pain medications. There are a number of dental infections that cause this type of~     debilitating pain. One such dental infection is termed periapical abscess. This infection~     involves the tooth pulp. These infections can arise in three ways: introduction through a~     defect in the enamel and dentin; from a periodontal pocket or an adjacent tooth; or~     hematogenous seeding of the pulp from mechanical irritation. As this disease process~     continues there are a number of complications including chronic pain and, more seriously,~     the spread of infection into deep spaces which can be a life threatening condition.~      The Emergency Department treatment of this infection includes pain control, antibiotics and~     dental referral for ultimate management of the infection.~      The purpose of our study is to investigate whether the addition of oral steroids will alter~     the time until patient experiences improvement in their dental pain. Steroids are a commonly~     used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain~     relief from throat pain. As the pain from periapical infection is thought to be largely from~     the pressure we speculate that the anti-inflammatory effects of steroids may decrease the~     inflammation thus the pressure and may ultimately lead to a decrease in time until the~     patient experiences some relief from their pain.~   "
3950|NCT03005509|"~     A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality~     Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma~     patient outcomes at four trauma centres in India.~   "
3951|NCT03005496|"~     This study is a randomized controlled trial which compares the effect of zinc,~     beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The~     measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF,~     NFκB, and IL-1β levels in placenta.~   "
3952|NCT03005483|"~     This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral~     10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in~     children from 3 months to 16 years submitted unilateral limb surgery.~   "
3953|NCT03005470|"~     National and international guidelines that guide evidence-based clinical practice advocate~     an effort to improve blood pressure control based on changing lifestyle and use of blood~     pressure lowering medication. However, the effectiveness of the approach usually depends on~     patient adherence to both types of interventions - pharmacological and behavioral. Lack of~     success on blood pressure control has increased the scope of interventions to improve~     adherence and to reduce cardiovascular risk factors without overburdening the public health~     system. The use of technologies - mobile or smart phones, games, blogs, internet and video~     conferencing - to implement interventions can reduce costs and increase coverage.~      Interactive interventions have been associated with a reduction in systolic blood pressure~     of 3-8 mmHg in patients with hypertension. These interventions were individually tailored to~     patient specificities and involved self-monitoring of blood pressure and lifestyle changes,~     including regular physical activity, DASH diet, restriction of dietary salt intake, and~     weight control. However, the effectiviness of these interventions may have short half-lives~     without periodic reinforcement, either to adhere to pharmacological treatment or behavioral~     changes. Innovative technologies can be used to achieve lasting effect and even greater~     blood pressure reduction.~      Therefore, the purpose of this study is to compare effectiveness of four strategies to~     reduce blood pressure and improve lifestyle.~   "
3980|NCT03005119|"~     A Phase II, double-blind, randomized, placebocontrolled, parallel-group study. Sixty (60) MS~     patients will be enrolled. PTL201 doses will be titrated over a one-week period until~     reaching MTD for each participant. The MTD will be administered for three weeks thereafter.~     Participants demonstrating response to treatment will continue self administering daily~     PTL201 treatment or placebo, for an additional four weeks. Participants will fill a daily~     diary.~   "
3954|NCT03005457|"~     Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant,~     game-based CI therapy. Pre/post study design. Participant received a target of 30 hours~     game-based motor intervention, 100 hours constraint of the less affected upper extremity,~     and 5 hours therapist consultation (including completion of a behavioral contract at the~     first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment~     and post-treatment testing performed within 1 week prior to and 1 week post-intervention by~     an independent tester.~   "
3955|NCT03005444|"~     Liver cirrhosis has traditionally been seen as a state of hypocoagulability and can be~     protected against thrombosis. However, recent studies have completely changed this paradigm.~     Patients with liver cirrhosis have an impaired hepatic synthesis of procoagulation factors~     but also anticoagulation factors, which is associated with an increase in other procoagulant~     factors such as factor VIII and von Willebrand factor which determines an elevated thrombin~     generation and, ultimately, a hypercoagulability state. Several consequences of~     hypercoagulability can be expected, such as portal vein thrombosis and venous~     thromboembolism. In addition to the potential direct deleterious consequences for the~     development of portal vein thrombosis, recent data have shown a close relationship between~     the activation of coagulation and faster progression of liver fibrosis.~      Bacterial translocation is a common problem and plays an important role in the pathogenesis~     and complications in patients with decompensated cirrhosis, including infections as well as~     hepatic encephalopathy and hepatorenal syndrome. To date, several biomarkers of BT have been~     proposed, which include bacterial DNA, soluble CD14, lipopolysaccharides endotoxin,~     lipopolysaccharide-binding protein, calprotectin and procalcitonin. Besides, endotoxemia and~     activation of the TNFa-pathway may be also considered key components in the pathogenesis and~     aggravation of portal hypertension and its complications.~      Anticoagulation therapy has a beneficial effect on survival in patients with idiopathic~     pulmonary fibrosis. Besides, a pilot study showed that the use of anticoagulants warfarin~     for 8 weeks improved the liver elasticity determined by Fibroscan® (Dhar A, et al. J~     Hepatology 2012. Abstract). An ongoing study of warfarin for the prevention of fibrosis due~     to recurrent hepatitis C should also contribute to an understanding of the role of the~     haemostatic system and fibrosis (http: //www.controledtrials.com/IRSCTN12504151).~      On the other hand, a recent prospective study in a group of 70 patients with liver cirrhosis~     (Child B and C stages up to 10 points) who were randomized to receive enoxaparin for a year~     (n = 34) vs no intervention (n = 36) showed that anticoagulant treatment with enoxaparin is~     safe and effective, significantly reducing risk of PVT development and liver decompensation,~     markedly improving overall survival. This study provides exciting preliminary data regarding~     the potential use of prophylactic anticoagulation in improving clinical outcomes in~     cirrhosis, beyond the prevention of portal vein thrombosis. This study suggested that the~     effect was partly due to a direct effect of reducing BT and levels of proinflammatory~     cytokines. However, this study included few patients, was not double blind, and did not have~     a placebo group. Therefore, despite the spectacular results, the use of prophylactic~     anticoagulant therapy has not become routine practice in patients with cirrhosis and more~     studies are needed to assess the potential usefulness of anticoagulation in improving the~     prognosis of liver cirrhosis.~      Transjugular intrahepatic portosystemic shunts (TIPS) are now routinely used to treat the~     complications of portal hypertension, such as variceal bleeding and refractory ascites. TIPS~     is the most effective method to prevent rebleeding, however, it is burdened with increased~     risk of hepatic encephalopathy and deterioration of liver function in patients with advanced~     cirrhosis. Notably, TIPS can not only relieve portal pressure but also can redirect the~     portal blood flow through the shunt directly into the systemic circulation which can cause~     systemic hemodynamic changes.~      Given the preliminary data suggesting a beneficial effect of prophylactic anticoagulation~     with LMWH in cirrhotic patients, this multicenter randomized controlled study attempts to~     demonstrate the effect of long term LMWH therapy after TIPS on survival in cirrhotic~     patients with variceal bleeding.~   "
3956|NCT03005431|"~     Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to~     receive government funded services for their child. During this delay parents need support~     and training to promote their child's development. The purpose of this research is to~     develop and evaluate an on-line, parent training and support program that will assist~     parents during this time. It is predicted that if parents receive on-line training and~     support they will increase their parenting knowledge and skills, reduce their stress, and~     create better outcomes for their child, in comparison to parents who do not receive the~     training. The experimental study (n=60) will use a randomized, masked, waitlist control~     design that compares a treatment group to a control group. Descriptive statistics will be~     used to describe differences between groups, ANCOVA's to test for differences between~     groups, and Pearson correlations to describe the relationship between parent stress and~     outcomes.~   "
3957|NCT03005418|"~     This study evaluates the use of the Human Acellular Vessel (HAV) in adults with arterial~     trauma in the lower limb who are undergoing vascular reconstructive surgery. All subjects~     will be implanted with a HAV as an interposition vessel or bypass using standard vascular~     surgical techniques. There is no control arm.~   "
3958|NCT03005405|"~     This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions~     moderate caries using sealants as an alternative to the restorations on occlusal surfaces of~     deciduous teeth. Initially, a non-inferiority study was designed in order to verify if~     sealing could be non-inferior than restoration. In this case, it could be preferable since~     it is less invasive. Therefore, cost will be put forward into the analysis considering even~     reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability~     could be another differential point between treatments.~   "
3959|NCT03005392|"~     -  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)~          strengthens their physical fitness.~        -  Exercising improves muscular and functional mobility fitness after finalizing~          chemotherapy in children and teenagers diagnosed with ALL.~        -  Assess cardiological changes~   "
3960|NCT03005379|"~     The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is~     effective vs. placebo in the prevention of C. difficile infection recurrence.~   "
3961|NCT03005366|"~     -  The main objective of this project is to study the efficacy and the mechanistic value~          of blocking both atrial specific and atria-preferential dynamics of ionic currents to~          terminate paroxysmal atrial fibrillation (AF).~        -  The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics~          of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward~          sodium current - , respectively) will be more effective to terminate paroxysmal AF~          episodes with fast atrial activation rates, than a classical INa blocker, which will be~          more effective to terminate AF episodes with slower activation rates.~        -  The investigators will include patients without structural heart disease and~          short-lasting AF episodes (<48 h.). Double blind and single center study, in which~          patients will be randomly assigned to a cardioversion group using intravenous~          flecainide or to an atria-preferential and atrial-specific blockade group using~          intravenous vernakalant. Patients will be routinely monitored in the electrophysiology~          room to acquire both 12-lead digitized ECG signals and non-invasive body surface~          potential mapping. Atrial signals will be extracted from both the multisite body~          surface and ECG recordings to obtain temporal and spectral parameters, and measure~          organization and atrial rate in both groups. The results obtained in the clinical~          setting will be studied in mathematical models to understand their capability to~          terminate paroxysmal AF. The project expects to provide consistent, reliable and~          reproducible parameters that will assist clinicians to know what type of paroxysmal AF~          episodes will be more suitable to effectively terminate, upon administration of drugs~          with an atrial specific and atria-preferential profile.~   "
3962|NCT03005353|"~     Fungal infections have increased over the last two decades, largely because of the~     increasing size of the population at risk, including patients who are immunocompromised,~     broad-spectrum antibiotics and intravascular catheter users. Essential oils and other~     extracts of plants have evoked interest as sources of natural products. They have been shown~     to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To~     the best of our knowledge, no study has examined the efficacy of cumin seed extract on~     relieving vulvovaginal candidiasis in vivo.~   "
3963|NCT03005340|"~     Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover~     study to evaluate the safety and pharmacokinetic characteristics after coadministration of~     C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in~     healthy male volunteers~   "
3964|NCT03005327|"~     The overall objective is to evaluate X4P-001 in the treatment of patients with WHIM~     Syndrome.~   "
3965|NCT03005314|"~     Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4~     in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common~     in China. The esophageal cancer during these stages is no longer localized lesions, and~     cancer will be transferred to other organs of the body through blood transmission, leading~     to tumor metastasis, which is the main cause of the patients' death. The tumor cells invade~     the surrounding tissues of primary tumor cells and enter the blood and lymphatic system,~     thus the circulating tumor cells (CTC) is formed and transported to a distal tissue, then~     effusing, adapting to the new microenvironment and finally forming metastases through the~     process of seeding, proliferation and colonization.~      Recently, the controversy of surgical treatment of esophageal carcinoma is concentrated on~     the neoadjuvant therapy during perioperative period. NCCN guideline of 2015 recommended that~     patients with esophageal squamous cell carcinoma in T1b, N + and T2-T4a, N0-N + may consider~     preoperative neoadjuvant therapy, but its supporting literature (David Cunningham 2006, Marc~     Ychou 2011 and P. van Hagen, 2013) includes patients with pathology of the type~     adenocarcinoma. The esophageal cancer treatment guidelines of Japan 2015 adopted the opinion~     of NCCN Guidelines, and recommended neoadjuvant chemotherapy and radical surgery as the~     standard treatment for stage II and III esophageal cancer patients based on the results of~     randomized controlled clinical trial JCOG9907. However, the guidelines also pointed out that~     the role of neoadjuvant chemotherapy for resectable T1-3N0-1M0 cancers remains unclear~     according to the results of some meta-analysis.~      The investigators choose the detection of peripheral venous blood CTCs and the disease-free~     survival as the main index, to compare the treatment effect of patients, those received~     neoadjuvant therapy, surgery and those received directly surgery, postoperative chemotherapy~     with esophageal squamous cell carcinoma in stage Ⅱ, III by means of evidence-based medicine;~     Define the indication of neoadjuvant chemotherapy in the treatment of esophageal squamous~     cell carcinoma in stage Ⅱ, III; Draft the solution to evaluate the treatment effect of~     neoadjuvant chemotherapy to esophageal cancer in stage Ⅱ, III, and the indication of~     neoadjuvant chemotherapy by test the peripheral venous blood CTCs and join the Chinese~     clinical guideline.~   "
3966|NCT03005301|"~     The present study is a prospective, two-center, randomized, controlled, open-label,~     non-inferiority trial evaluating the efficacy and safety of a new intelligent~     electroacupuncture instrument in treating neck pain caused by cervical spondylosis.~   "
3967|NCT03005288|"~     This study will assess the safety, pharmacokinetics and efficacy of bimagrumab when~     administered in obese patients with type 2 diabetes~   "
3968|NCT03005275|"~     In polycystic ovary syndrome (PCOS) patients, both in vitro maturation (IVM) and~     intra-cytoplasmic sperm injection (ICSI) are indicated as optional treatments. Although~     recently ICSI techniques have been reported as more successful the IVM in achieving~     pregnancy, they have also become much more expensive for the couples involved. Whilst most~     high-income countries offer Assisted Reproductive Technology (ART) procedures fully or~     partially paid by the government, the patients in low or middle-income countries have to~     cover self-fund infertility treatments. With limited resource, a study conducting based on~     the prevalence - based cost - effectiveness analysis is necessary for health managers,~     policy makers and especially to assist patients' decision making in these countries.~      However, there are still limited published studies that have evaluated the~     cost-effectiveness of these strategies are available in the literature. This study is~     conducted based on the prevalence - based cost - effectiveness analysis from the patient's~     perspective. Activity - based costing method is used to cost in all levels of the healthcare~     system, which the patients have to pay directly or indirectly. It also analyses incremental~     cost - effectiveness to evaluate the cost - effectiveness of IVM and ICSI in PCOS women.~   "
3969|NCT03005262|"~     To allow a patient continued access to MLN8237~   "
3970|NCT03005249|"~     To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.~   "
3971|NCT03005236|"~     The proportion of elderly patients with end-stage kidney disease undergoing renal~     replacement therapy (RRT) is steadily increasing. Although kidney transplantation remains~     the optimal RRT of choice, it is clear that older adults have a differential risk versus~     benefit profile after kidney transplantation compared to younger adults. No age-adapted~     immunosuppression for older adults has been shown to improve kidney allograft outcomes but~     recent sub-analyses of clinical trial data has hinted at improved outcomes for older kidney~     transplant patients receiving Envarsus versus standard twice-daily tacrolimus formulations.~     This feasibility study will investigate this effect to see whether a full scale randomised~     controlled trial is warranted and to provide information regarding study feasibility.~   "
3972|NCT03005223|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20163 in Healthy Volunteers~   "
3973|NCT03005210|"~     Comparative randomized, single dose, three way three sequence two treatment partial~     replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and~     Ledipasvir from Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni~     90/400 mg Tablets (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.~   "
3974|NCT03005197|"~     Teeth injuries are considered one of the most challenging events that occur in dentistry,~     especially in children. After an injury, there is a possibility that the blood supply to the~     tooth may become affected and compromised leading to nerve and blood vessels death with the~     tooth described as a non-vital tooth.~      The conventional diagnostic tools available to assess tooth nerve/blood supply are not~     always reliable. Child cooperation and understanding contribute greatly to this shortfall.~     Failure to assess the vitality of the tooth may result in pain, swelling or infection of the~     tooth or de-vitalising a normal tooth which may render the tooth weak for the future and~     possibly losing the tooth.~      The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more~     reliable than the traditional techniques. We aim to assess if this device can predict and~     assess whether the tooth is alive or dead during the follow up visits of the injury along~     the other conventional tests.~   "
3975|NCT03005184|"~     This study tests the hypothesis that endogenous bradykinin contributes to effects of a~     combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)~   "
3976|NCT03005171|"~     The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in~     patients undergoing open upper abdominal surgery; when compared with thoracic epidural~     analgesia. Half of participants will receive intravenous lidocaine infusion, while the other~     half will receive thoracic epidural bupivacaine infusion.~   "
3977|NCT03005158|"~     Patients with suspected acute coronary syndrome account for a tenth of all presentations to~     the Emergency Department and up to 40 per cent of unplanned hospital admissions. The~     majority of patients do not have a heart attack (myocardial infarction), and may be safely~     discharged from the Emergency Department.~      The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients~     with suspected acute coronary syndrome reduces length of stay and allows more patients to be~     safely discharged from the Emergency Department. This pathways utilizes high-sensitivity~     cardiac troponin I testing and will rule out myocardial infarction if troponin~     concentrations are <5 ng/L on presentation, with further testing indicated at 3 hours only~     in those presenting early or with troponin concentrations between 5 ng/L and the 99th~     centile.~      In six secondary and tertiary centres across Scotland, the investigators will introduce the~     pathway as part of a stepped wedge cluster randomized controlled trial. Sequential~     hypothesis testing will evaluate the efficacy and safety of the pathway. The primary~     efficacy end-point will be length of stay from time of presentation until final hospital~     discharge and the primary safety end-point will be survival free from type 1 or 4b~     myocardial infarction or cardiac death from discharge to 30 days. The study population will~     consist of those patients with cardiac troponin concentrations within the normal reference~     range (<99th centile) at presentation.~   "
3978|NCT03005145|"~     The World Health Organization, U.S. Centers for Disease Control and Prevention, Association~     of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all~     declared antimicrobial resistance a global threat to health, based on rapidly increasing~     resistance rates and declining new drug development. Up to 30-50% of antibiotic use is~     inappropriate, and excessive durations of treatment are the greatest contributor to~     inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to~     be as effective as longer antibiotic treatment for a range of mild to moderate infections. A~     landmark trial in critically ill patients with ventilator-associated pneumonia showed that~     mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of~     treatment. Similar randomized trial evidence is lacking for the treatment of patients with~     bloodstream infection, which affects 15% of critically ill patients, and an estimated 50,000~     Canadians per year.~   "
3979|NCT03005132|"~     Integrative analysis of GBM~   "
4328|NCT03000582|"~     The purpose of this study is to examine the pharmacokinetics of creatine nitrate~     supplementation.~   "
3981|NCT03005106|"~     The proposed registration study is designed as a phase III open-label, controlled,~     randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue~     in promoting autologous skin tissue regeneration of complex skin defects due to thermal~     burns. The proposed study will include patients with 3-49% total body surface area (TBSA)~     complex skin defects due to thermal burns with intact dermal elements for which excision and~     autografting are clinically indicated. The study has been designed to focus on the~     evaluation of efficacy and safety of StrataGraft skin tissue, while also assessing the~     potential for StrataGraft skin tissue to promote healing of complex skin defects due to~     thermal burns as an alternative to donor site harvesting and autografting. Targeted~     enrollment for this study is up to 70 subjects with complex skin defects caused by thermal~     burns that containing intact dermal elements and for which surgical excision and autografts~     are clinically indicated.~   "
3982|NCT03005093|"~     The purpose of this study is to test the reliability and validity of the Turkish~     Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing~     disorders.~   "
3983|NCT03005080|"~     This study will use a 22 gene pharmacogenomics panel on 30 children with persistent~     Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.~   "
3984|NCT03005067|"~     This study will be conducted in adult participants with symptoms of common cold assessing if~     1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.~     The study will also evaluate the safety of 1146A compared to placebo.~   "
3985|NCT03005054|"~     The proposed study is designed as a phase II open-label, controlled, randomized,~     multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or~     multiple applications of StrataGraft skin tissue as an alternative to autografting in~     promoting the healing of excised full-thickness complex skin defects resulting from acute~     traumatic skin loss. The proposed study population will include patients with up to 49%~     Total Body Surface Area (TBSA) complex skin defects including a full-thickness component.~     The study has been designed to focus on the evaluation of safety and tolerability of~     prolonged exposure to increasing amounts of a single or multiple applications of StrataGraft~     skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of~     the full-thickness component of these complex skin defects as an alternative to donor site~     harvesting and autografting. Targeted enrollment for this study is up to 20 subjects with~     complex skin defects due to acute traumatic skin loss which require surgical excision and~     autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment~     area receiving StrataGraft skin tissue.~   "
3986|NCT03005041|"~     The purpose of this study is to investigate the consumer perception of an experimental~     mouthwash formulation in population with dry mouth~   "
3987|NCT03005028|"~     In the present study we aim at validating the computation of FFRangio values from the~     angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a~     completely blinded manner. Investigation of a wide range of users in various conditions may~     strengthen the reliability of the FFRAngio measurements.~   "
3988|NCT03005015|"~     The primary objective of this multicenter, randomized phase II trial is to assess the~     efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to~     doxorubicin in advanced or recurrent endometrial cancer.~      The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib~     activity and establishing a cutoff value as potential selection criteria for phase III.~      Other secondary objectives are to assess the tolerability and safety of lenvatinib in this~     setting and overall survival, response and disease control.~   "
3989|NCT03005002|"~     This pilot clinical trial studies the side effects and how well durvalumab and tremelimumab~     work in treating patients with microsatellite stable colorectal cancer that has spread to~     the liver. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with~     the ability of tumor cells to grow and spread.~   "
3990|NCT03004989|"~     To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have~     participated in return-to-work group programmes (RTW-GPs) and see how the programmes could~     strengthen their work ability.~   "
3991|NCT03004976|"~     The primary objective of this study is to determine the efficacy of a single intravenous~     infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in~     patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB~     or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or~     myeloablative medications prior to the infusion. Subjects will be followed for one year post~     infusion for safety and efficacy. Assessments will examine safety and tolerability of the~     infusion, change in neurological symptoms, change in quality of life, and emotional and~     cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and~     365 days post infusion.~   "
3992|NCT03004963|"~     Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease~     patients. Volume overload is a predictor of mortality in PD patients. In this Randomized~     controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency~     bioimpedance device, to measure the level of overhydration in PD patients and explore its~     value in fluid management in peritoneal dialysis patients as well as their prognosis.~   "
3993|NCT03004950|"~     This study is an observational non-interventional study which will examine a) the accuracy~     of biomarkers in predicting renal and cardiovascular outcomes after contrast-induced acute~     kidney injury.~      This study will obtain de-identified human plasma & urine samples and corresponding~     de-identified research study data on subjects who are enrolled into the Prevention of~     Serious Adverse Events Following Angiography (PRESERVE) study and Biomarker Collection and~     Analysis in the PRESERVE Trial (VA CSP #578). Biomarker analyses will be performed on the~     de-identified samples and merged with de-identified research study data.~   "
4003|NCT03004820|"~     This is a single-arm, open-labeled and phase II futility study. Application of Remote~     ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the~     study. The study is to test whether RIC is effective in preventing ischemic evens after a~     minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety~     and compliance of chronic RIC. Medication strategy is based on physician's best judgement.~   "
4329|NCT03000569|"~     This study will assess the safety, tolerability, pharmacokinetics and efficacy of SAGE-217~     in up to 30 subjects with Parkinson's Disease of Moderate Severity.~   "
3994|NCT03004937|"~     Busy Primary Care providers (PCPs) have complex practices with many competing demands,~     making it difficult to improve their HL identification rates. Little research has been~     conducted to identify effective approaches to address the poor PCP knowledge and provide~     tools for them to better identify/refer patients with HL for appropriate intervention.~     Current data suggests there is a critical need to redesign how PCPs deliver hearing health~     care (HHC) by developing focused educational programs and simple clinical management tools~     to help them integrate HHC into their practices. To address this need, this study will~     educate providers on hearing loss (HL) screening/treatment as well as create a Best Practice~     Alert (BPA), or clinical prompt, that is configured for maximal effectiveness in reminding~     PCPs to ask their patients if they think they have a HL. This combination of education for~     providers and clinical reminder could help increase HL screening rates but how much is not~     clear. This 5 year R21/R33 study funded by National Institute of Deafness and Communicative~     Disorders seeks to provide detailed understanding of both how educating providers on HL and~     the use of an effective BPA affects HL screening rates and identification for people with~     mild to moderate hearing loss.~   "
3995|NCT03004924|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial~     conjunctivitis.~   "
3996|NCT03004911|"~     The purpose of this study is to test the efficacy of a mobile application named ProFibro to~     promote self-care, and improve symptoms and health-related quality of life in Brazilian~     patients with fibromyalgia.~   "
3997|NCT03004898|"~     CKD is a global endemic disease with increased comorbidities and mortality. The prevalence~     and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The~     prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk~     factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education~     deep into the community remains limited. The aims of this study are:~        1. Explore risk factors associated with CKD in the community~        2. Establish multidisciplinary care model in the community~        3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in~          behavioral , physiological, immune and metabolomics aspects~        4. Provide bio-specimen repository for future study~   "
3998|NCT03004885|"~     Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of~     30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the~     difference between the end-inspiratory and the end-expiratory airway pressure, appears as an~     important factor contributing to mortality in patients with the ARDS. In patients already~     receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving~     pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the~     driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body~     weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation,~     providing the respiratory rate is constant. In this setting, implementing an extracorporeal~     CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have~     previously demonstrated that combining a membrane oxygenator within an hemofiltration~     circuit provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this~     study, we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a~     PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used~     to provide decarboxylation without renal replacement therapy. The study will consist in~     three periods:~        -  The first period will address the efficacy of the PrismaLung device at tidal volume of~          6 and 4 ml/kg PBW using an off-on-off design.~        -  The second part of the study will investigate the effect of varying the sweep gas flow~          and the mixture of the sweep gas on the CO2 removal rate (random order).~        -  The third part will compare three ventilatory strategies applied in a cross-over design~          :~             1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure~               (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).~             2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure~               between 23 - 25 cmH2O.~             3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table~               (ARMA).~      Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary~     inflammatory and fibrosis pathway will be assess before and after each period using~     bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be~     investigate. Main measurements will include respiratory mechanics, transpulmonary pressure,~     work of breathing, end-expiratory lung volume and tidal ventilation using electrical~     impedance tomography.~   "
3999|NCT03004872|"~     The purpose of this study is to evaluate potential risk factors for developing postpartum~     depression or posttraumatic stress disorder during the first year postpartum in patients who~     have no preexisting history of PTSD or PPD.~   "
4000|NCT03004859|"~     Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an~     increased risk of thromboembolic stroke. The risk to suffer from AF increases with age.~     Early detection of AF and anticoagulation seem the most effective way of preventing~     ischaemic stroke in patients at risk. The guidelines of the European Society of Cardiology~     recommend opportunistic screening for AF by pulse check at each general practitioner visit~     for all patients aged 65 years or older.~      The objective of this study was to test whether an opportunistic AF screening with a~     hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF~     among people in the age of 65 and older. Besides a pulse palpation with a hand-held~     ECG-stick the screening in the pharmacies also includes a questionnaire related to~     demographics and medical history of the subject as well as several questions concerning the~     stroke risk stratification (CHA₂DS₂-VASc). Every subject with a positive test result~     (indication on AF) is insistently asked to make an appointment with his or her general~     practitioner. The subject receives an information letter for his or her general practitioner~     that adverts to the positive screening result and the necessity of further diagnostic~     Investigation.~      In order to assess the incidence of unknown AF as well as accomplish the secondary~     objectives of this study, two follow-ups by means of telephone interviews are performed.~     First, all subjects with a positive test result are called 8 weeks after the screening in~     the pharmacies was conducted. The subject is asked several questions concerning personal~     data/demographics, the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea~     and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the~     therapy, the Intervention and the mace. 12 months after the screening in the pharmacies was~     performed, all participating subjects were called. The list of questions is similar to the~     one that is used during the first telephone interviews after eight weeks.~   "
4001|NCT03004846|"~     GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR)~     gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and~     systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque~     psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be~     conducted in two parts. Part A will be an open-label, single arm study and part B will be a~     double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8~     adult subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be~     enrolled. Total duration of study will be approximately 14 weeks. The results of this study~     will provide preliminary information about safety and efficacy of the drug and will help in~     providing the guidance for further development strategy.~   "
4002|NCT03004833|"~     The aim of the trial is to improve first-line treatment for early unfavorable cHL by~     introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy~     (AVD).~      The primary objective is to show efficacy of the two experimental treatment strategies.~     Secondary objectives are to further evaluate efficacy, show safety and feasibility and~     perform correlative studies.~   "
4039|NCT03004352|"~     The aim of the study is to determine if increased retrograde shear would further deteriorate~     the already impaired vascular function in severe COPD patients.~   "
4004|NCT03004807|"~     Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons~     and have an increased demand for many of these micronutrients. Multivitamin/multimineral~     supplement offer a simple way for adults to improve nutrient intake, but their ability to~     measurably affect micronutrient status in older adults has never been explored. This study~     intends to recruit healthy, non-smoking men aged 70 years or older. After meeting entry~     criteria, subjects will be required to restrict the use of supplements and/or fortified~     foods. A month after these restrictions have begun, subjects will come to the clinical~     research center to take cognitive tests, undergo activity monitoring, provide blood samples~     for nutrition testing, and take food frequency questionnaires. Subjects will then be~     randomized into one of two groups - one consuming a multivitamin/multimineral supplement~     (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will~     consume 1 tablet each day for sixteen weeks. After this period, subjects will return to the~     clinical research center and repeat cognitive tests, activity monitor, blood sampling, and~     food frequency questionnaires. These data will be assessed to determine if multivitamin~     consumption results in changes in various nutrients versus taking a placebo (primary~     outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health,~     inflammation, blood pressure or cognitive function (secondary outcomes). The investigators~     expect that results of this study will add to the gneeral understanding if~     multivitamin/multimineral formulas can improve nutrition status of older adults, and~     therefore have the capacity of altering markers of health.~   "
4005|NCT03004794|"~     Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be~     obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010~     revision of the McDonald criteria.~      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity~     numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient~     in different centers were counted only once.~   "
4006|NCT03004781|"~     This research compared the efficacy of two parenting interventions that vary according to~     the number and the nature of variables in reducing preschoolers' externalizing behavior~     (EB). The goal was to identify which parenting intervention format (one-variable versus~     two-variable) caused higher behavioral adjustment in children.~   "
4007|NCT03004768|"~     An oral dose in healthy subjects to obtain information about the absorption, metabolism, and~     excretion (AME) of BMS-986165~   "
4008|NCT03004755|"~     Historically, cancer research has been limited by sample acquisition in late stage disease,~     often restricted to single sites of disease with limited parallel clinical data collection~     in terms of prior therapy exposure. The PEACE study is intended to facilitate tissue~     donation from multiple tumour sites in the post-mortem setting and enable future research~     using samples collected at post-mortem within different disciplines related to cancer~     research.~   "
4009|NCT03004742|"~     This study will measure the effect of ingesting a flavonoid-rich supplement on various~     biomarkers in overweight/obese women during a 12-week period. The flavonoid-rich supplement~     contains a mixture of flavonoids including quercetin, catechins from green tea extract, and~     anthocyanins from bilberry extract, and other food components that facilitate flavonoid~     bioactivity including fish oil, caffeine, and vitamin C.~   "
4010|NCT03004729|"~     The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to~     recognize cow's milk related symptoms in infants and young children.~      Many infants and toddlers with symptoms that can be related to intake of cow's milk and~     cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific~     markers.~      The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and~     investigate if the CoMiSS tool could be an alternative to the open challenge test needed to~     confirm the diagnosis of Cow Milk Protein Allergy.~   "
4011|NCT03004716|"~     The purpose of this study is to assess the feasibility and the reliability of a~     telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive~     pulmonary disease.~      The feasibility is assessed using the patient's satisfaction and it ease of use.~      The reliability of the remote telemonitoring system is assessed comparing the local data~     (extracted from the monitoring device itself) and the data transmitted through the~     telemonitoring platform.~   "
4012|NCT03004703|"~     The main goal of this study is to evaluate the ability of a single administration of~     tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment~     elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of~     treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii)~     inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet~     activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety~     and tolerability.~   "
4013|NCT03004690|"~     Pandemics and re-emerging diseases put pressure on the health care system to prepare for~     patient care and sample logistics requiring enhanced personnel protective equipment (PPE)~     for health care workers. We generated quantifiable data on ergonomics of PPE applicable in a~     health care setting by defining error rates and physically limiting factors due to~     PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full~     body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four~     different tests (two laboratory tutorials, a timed test of selective attention and a test~     investigating reaction time, mobility, speed and physical exercise) during 6 working hours~     at 22°C on one day and 4 working hours at 28°C on another day. Error rates and physical~     parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related~     parameters were assessed hourly using questionnaires. Depending on the PPE system the most~     restrictive factors were: reduced dexterity due to multiple glove layers, impaired~     visibility by flexible face shields and back pain related to the respirator of the fully~     ventilated suit. Heat stress and liquid loss were perceived as restrictive at a working~     temperature of 28°C but not 22°C.~   "
4014|NCT03004677|"~     This study evaluates the effect of a late intervention of continuous skin-to-skin contact~     (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the~     intervention and the other half will receive standard care.~   "
4040|NCT03004339|"~     Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007~     Ointment in topical formulations~   "
4041|NCT03004326|"~     Multi-center observational study to evaluate the histopathology and transcriptome of~     cutaneous lesions in patients with several different types of vasculitis.~   "
4015|NCT03004664|"~     BACKGROUND AND SIGNIFICANCE:~      Diabetes is a national health problem, yet Latinos from low-income households are at greater~     risk. Although guidelines recommend that patients learn self-management strategies, many~     people are not able to do so effectively and cannot control their diabetes. Studies show~     that culturally competent self-management programming can help, but patients in preliminary~     research indicated that not all programs sufficiently respect patients' cultural values or~     account for their socio-economic limitations.~      STUDY AIMS:~      This project will compare two models for culturally competent diabetes self-management~     programming. The hypothesis is that the program model that best considers patient culture~     and accommodates patient socio-economic circumstances will have the best outcomes.~      COMPARATORS:~      2 diabetes self-management program models used by many Latino patients from low-income~     households in Albuquerque, New Mexico~        1. The Diabetes Self-Management Support Empowerment Model~        2. The Chronic Care Model~      STUDY POPULATION:~      Patients will be 240 individuals who consider themselves to be Latino and who are from~     low-income households. In addition, 240 patients will identify a corresponding social~     support to participate with them. Outcomes will be measured based on the 240 patient~     participants. Social support data will be measured as a covariate to understand patient~     outcomes.~      PRIMARY OUTCOME:~      Improved capacity for diabetes self-management measured as diabetes knowledge and patient~     activation or the ability to put that knowledge into action.~      SECONDARY OUTCOME:~      Successful diabetes self-management measured through reduced A1c, BMI and depression.~     Patient stress levels will also be measured using testing of hair samples to identify levels~     of cortisol as a biological marker for chronic stress.~      METHODS:~      Statistical calculations will be conducted to make sure that the things being compared are~     differences in program design and not differences in individual patient characteristics.~     This study will compare whether the programs improve diabetes health knowledge, ability to~     act, and A1c, BMI, depression and stress control, and determine which program is the best.~   "
4016|NCT03004651|"~     Comparison of the level of agreement between Power Doppler ultrasound measured number of~     synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen~     joints in obese (i.e. BMI>30) versus normally weighted RA patients.~   "
4017|NCT03004638|"~     To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of~     MEDI6012 in subjects with stable atherosclerosis.~   "
4018|NCT03004625|"~     A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein~     (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice~     daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.~   "
4019|NCT03004612|"~     Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to~     face this health problem. The goal of this clinical trial is to evaluate the effect of~     linagliptin + metformin vs metformin alone on physiopathological parameters, such as glucose~     metabolism, insulin resistance, insulin secretion and pancreatic beta cell function in~     patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months.~   "
4020|NCT03004599|"~     Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis~   "
4021|NCT03004586|"~     The goal of this clinical research study is to compare the effectiveness of a smaller,~     25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.~      The safety of the needles will also be studied.~   "
4022|NCT03004573|"~     Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs~     with a major impact on the quality of life. Social cognition is a complex system relying on~     emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts:~     emotional and cognitive), but also on the social and cultural environment and the personal~     history. The first step in this model is represented by the NMS, which seems to be altered~     in PD patients for both positive and negative emotions as shown in our preliminary study.~     The investigator purpose is to investigate the role of the treatment (levodopa and deep~     brain stimulation) on the functioning of the NMS.~   "
4023|NCT03004560|"~     The purpose of this study is to examine the psychological and psychosocial impact of~     surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to~     undergo bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will~     be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic~     surgery and 50 will be assigned to the percutaneous group. All patients will complete~     pre-operative psychometric testing to establish a baseline body-image score as well as a~     patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits~     will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after~     surgery. Subjects will complete the same psychometric measures to identify differences in~     psychological and psychosocial responses to standard laparoscopic and percutaneous scars.~     Patients will also complete a measure on scar satisfaction. The investigators hope to~     identify any differences between standard laparoscopic versus percutaneous approaches.~   "
4024|NCT03004547|"~     Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in~     the skin, muscle and skeleton - to cope with long term sodium loading. It is known that~     sodium stored in this non-osmotically active way, is profoundly inflammatory. Furthermore,~     inflammation has been associated with a number of uremic symptoms. The investigators will~     use novel Na+ MRI imaging to examine the Na+ deposition in skin, muscle and skeleton of~     three groups of patients: 1) chronic 3-times-a-week in-center hemodialysis patients, 2)~     peritoneal dialysis patients, and 3) patients with CKD stage 4-5; and compare these results~     to age and sex matched healthy controls. Additionally, they will investigate the association~     between sodium deposition in these tissues with uremic symptomatology and biochemical~     markers of metabolism.~   "
4025|NCT03004534|"~     The purpose of this study is to evaluate the effect of short-term treatment with ODM-201 on~     breast cancer cells (i.e., how the treatment may change the genes or proteins in breast~     cancer cells) and to evaluate its safety and the way it is tolerated by subjects.~      The intent is to study these changes in order to have a better understanding of the~     potential use of ODM-201 for women with EBC, know which patients are likely or unlikely to~     respond to this treatment, and determine how ODM-201 may be combined with other anti-cancer~     drugs.~   "
4026|NCT03004521|"~     LQD is a multicentre randomised clinical trial comparing the clinical and cost effectiveness~     of lithium versus quetiapine when used as add-on therapies to antidepressant medication for~     patients with treatment resistant depression. The Lithium versus Quetiapine in Depression~     (LQD) study will assess patients over 12 months to establish which (if any) treatment is~     more likely to improve TRD over a long duration of time. Professor Anthony Cleare is the~     Chief Investigator and recruitment is due to start in November 2016. Recruitment will begin~     in London, followed by additional sites in Newcastle and Oxford in early 2017.~   "
4069|NCT03003962|"~     This is a randomized, open-label, multi-center Phase III study to determine the efficacy and~     safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of~     advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic~     lymphoma kinase (ALK) wild-type and with PD-L1-high expression~   "
4027|NCT03004508|"~     Primary objective: The primary objective of this study is to assess the effect of Ginkgo~     biloba L. leaf extract (IDN 5933) in comparison to placebo in human subjects treated at~     therapeutic doses for 6 months on the level of DNA damage and genomic instability, measured~     with the Comet Assay and the Micronucleus assay, respectively .~      Secondary objective:~      The secondary objective of this study is to provide a preliminary assessment of the safety~     of Ginkgo biloba L. leaf extract (IDN 5933) in human subjects treated at therapeutic doses~     in term of adverse drug reaction, hepatotoxicity, genotoxicity.~   "
4028|NCT03004495|"~     To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of~     CHF6001 and CHF5259, in comparison with the single components, administered in healthy~     subjects via a multi-dose reservoir NEXThaler® DPI.~   "
4029|NCT03004482|"~     Video recording for term and preterm newborns hosted at the AUBMC Neonate ICU will be~     collected. The videos will capture movements, skin color changes, positioning, and other~     features relevant to the diagnosis in question. Recorded video images will be analysed by a~     computer software using the Eulerian Video magnification technology; then images will be~     correlated with simultaneously recorded physiological parameters (heart rate, respiratory~     rate and saturation). Images will be annotated by the clinician. Correlation between the~     skin coloration differentials and annotated physiological parameters may establish~     physiological indices. These may be used to extrapolate the existence or absence of disease~     states.~   "
4030|NCT03004469|"~     The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in~     patients with androgenetic alopecia.~   "
4031|NCT03004456|"~     Children with chronic diseases, particularly those who have received transplantation (e.g.~     cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as~     venipuncture multiple times per week. There is currently no standard of care for pain~     reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an~     outpatient. The study aims to determine the efficacy of distraction in reducing procedural~     pain and distress associated with venipuncture in pediatric post-transplant patients.~   "
4032|NCT03004443|"~     Increased inflammation has been implicated in the pathophysiology of a number of~     neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults~     in the United States alone. One mechanism by which inflammation may alter behavior is~     through increasing brain glutamate, a neurotransmitter that in excess has been implicated in~     neuronal toxicity and resistance to conventional antidepressant therapy. The goal of the~     proposed research is to test the hypothesis that inflammation alters behavior through~     increasing glutamate in specific brain regions, ultimately leading to behavioral changes.~      The proposed research is designed to determine the cause and effect relationship between~     inflammation and CNS glutamate as well as the relationship between CNS glutamate and~     specific symptoms. To accomplish these aims, investigators will administer a single infusion~     of either the tumor necrosis factor (TNF) antagonist infliximab or placebo (n=30 per group)~     to patients with high inflammation (CRP>3mg/L). A CRP>3mg/L was chosen because it is~     considered high inflammation according to guidelines by the American Heart Association.~     Moreover, a CRP>3mg/L is associated with significantly increased basal ganglia glutamate and~     with a clinical response to infliximab. Inflammatory biomarkers, basal ganglia glutamate as~     measured by MRS, and motivation and psychomotor activity will be assessed at baseline and~     days 1 and 3 and weeks 1 and 2 following infliximab or placebo administration.~   "
4033|NCT03004430|"~     To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive~     therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to~     increased spirituality as a potential mediating factor of positive mental health.~   "
4034|NCT03004417|"~     Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on~     pulmonary function and on symptoms benefits in comparison with placebo.~   "
4035|NCT03004404|"~     The primary objective of the Single-rising dose (SRD) part (trial part 1) is to investigate~     the safety and tolerability of BI 730357 in healthy subjects following oral administration~     of single rising doses. The secondary objective is the exploration of the pharmacokinetics~     (PK) including dose proportionality, and pharmacodynamics of BI 730357 after single dosing.~      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the~     relative bioavailability of tablet fasted versus oral solution fasted and the influence of~     food on the bioavailability of tablet fasted versus tablet fed.~   "
4036|NCT03004391|"~     In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU)~     program for ovarian cancer patients. The new FU program argues that there is no effect of~     routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish~     routine measurement of CA 125 to be part of the follow-up program.~      Shared Decision Making (SDM) can help health professionals develop a more individualized~     care plan in collaboration with the patient, as stated in the revised national FU program.~     Due to the complexity and challenges within ovarian cancer care, this is an evident area of~     focus.~      SDM is defined as an approach in which the clinician and patient go through all phases of~     the decision-making process together and share the preference for treatment and reach an~     agreement on treatment choice. Clinicians have information about disease, tests and~     treatments, whereas patients hold information about their life circumstances, goals of life,~     and preferences for healthcare. SDM thereby offers a way of individualizing recommendations,~     according to patients' special needs and preferences. SDM has potential to give the patients~     a higher quality of healthcare by putting the patient in the center of care.~      Decision aids (DA) are tools that can provide information and systematically describe the~     advantages and disadvantages of a specific intervention or monitoring, which can help~     patients become involved in decision making. Using evidence-based DA leads to improvement in~     knowledge, better understanding of screening, prevention and treatment options, and more~     accurate perception of risks for the patients.~      All participants fill in a demographic and Decisional Conflict Scale questionnaire at~     baseline. After having been presented with the decision aid and made a choice as to CA125,~     the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire~     dealing with confidence as to the choice made and the level of shared decision making~     experienced. Six months later the Decision Regret Scale questionnaire is to be completed to~     reveal any regrets in relation to the CA125 decision.~      For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible~     for this study will be asked for their opinion.~   "
4037|NCT03004378|"~     This study will be the first to evaluate whether the short- and long-term use of activity~     tracking devices improve short- and long-term weight loss in adolescents. The investigators~     will be the first to establish whether weight loss translates into a change in~     obesity-related biomarkers associated with adolescent obesity. In addition, the~     investigators will be the first to report outcomes after the implementation of activity~     tracking devices in conjunction with an intense adolescent weight loss program.~   "
4038|NCT03004365|"~     The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in~     multiple doses can effectively kill the bacteria in the oral cavity that cause dental~     caries.~   "
4042|NCT03004313|"~     The main purpose of this study is to integrate novel MRI techniques with positron emission~     tomography(PET) for the study of structural and molecular neuroplasticity in the brain of~     migraineurs, and its clinical association with changes in pain perception and modulation~     (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,~     assist doctors in better understanding how pain is felt and regulated in migraine sufferers.~   "
4043|NCT03004300|"~     The most frequent causes of mouth breathers are the adenotonsillar hypertrophy.~     Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this~     surgical treatment does not have its effect well elucidated and apnea has been cited in the~     literature as a residual outcome. Other types of supporting treatment may also been involved~     such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment,~     among them rapid maxillary expansion (RME).~      RME corrects the morphological constriction of the upper arch caused by buccal breathing and~     also reduce the airway resistance. Despite reports of RME influencing volume enhancement in~     pharyngeal airway, there are still few three-dimensional studies following the~     post-expansion effects. In addition, these changes are doubtful due postural changes of the~     tongue during the tomography exam. Conflicts of results are also present for changes in the~     nasal septum of children. The main alteration mentioned is the increase in the length of the~     lower third of the septum.~      The investigators propose a randomized, prospective, controlled clinical trial in patients~     with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be~     treated with RME and adenotonsillectomy when the obstruction is present. The purpose of this~     study is elucidate if there is different outcomes considering the moment of RME treatment~     before or after the adenotonsillectomy.~   "
4044|NCT03004287|"~     This study will assess whether adding one of the newest multiple myeloma therapies,~     daratumumab, into the Total Therapy approach helps patients live longer with fewer side~     effects~   "
4045|NCT03004274|"~     The goal of this study is to assess whether running deep wound stiches will be superior to~     deep interrupted stiches in body contouring surgeries in massive weight loss patients. This~     is a split-wound study, thereby providing an internal control within each wound. Each side~     of the wound will be randomized to receive one of the two suturing techniques. Patients and~     raters will be blinded to the suture technique used in both wound-halfs.~   "
4046|NCT03004261|"~     Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for~     recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study~     the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte~     (CMV-CTL) given to transplant recipients~      CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived~     from donor peripheral blood mononuclear cells for a period of 18~21 days.The patients will~     receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The~     CMV-DNA level will be monitored weekly after transfusion.~   "
4047|NCT03004248|"~     This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of~     moderate to severe glabellar lines following single and repeat administration.~   "
4048|NCT03004235|"~     The purpose of this study is to collect non-invasive observational data in suspected or~     known carbon monoxide poisoning.~   "
4049|NCT03004222|"~     The purpose of this research is to determine if spraying a local anesthetic to the cecum~     after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed~     after surgery and reduces the time to discharge from the hospital.~   "
4050|NCT03004209|"~     This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis.~     Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.~   "
4051|NCT03004196|"~     Orthodontic appliance causes increase in plaque accumulation, especially around brackets,~     wires and attachments. Advances in orthodontics in recent time have led to improved quality~     of appliance and treatment procedures ultimately resulting in improvised standard of patient~     care.~      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic~     appliances and create acidic environment in the oral cavity leading to enamel~     demineralization around the brackets and white spot lesions.~      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and~     chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who~     are not using them.~   "
4052|NCT03004183|"~     This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation~     therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment~     before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and~     metastatic non-small cell lung cancer (NSCLC). In situ oncolytic virus therapy will consist~     of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus~     valacyclovir therapy.~   "
4053|NCT03004170|"~     The purpose of this study is to determine if a brief behavioral intervention delivered over~     the telephone is effective at reducing occasions of condomless sex in persons living and~     aging with HIV.~   "
4054|NCT03004157|"~     Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring~     effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs~     in the United States annually. Only 8% of the patients survive to hospital discharge and of~     these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are~     below age of two and have poorer chance of survival versus older children~   "
4065|NCT03004014|"~     Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the~     site and configuration of upper airway obstruction in patients with obstructive sleep apnea~     (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep.~     Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical~     treatment.~      Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be~     enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during~     the night. Propofol induced sleep will be performed at the operating room before surgery.~     The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification~     will be used to compare site and configuration of collapse between studies. Peak inspiratory~     flow will also be compared between studies.~   "
5809|NCT02981134|"~     The purpose of this study is to evaluate usefulness of coronary computed tomographic scan~     for prediction of clinical events after everolimus-eluting bioabsorbable scaffold~     implantation for coronary artery disease.~   "
4055|NCT03004144|"~     This study is a cross-sectional study investigating the impact of assistive forces applied~     by the body-weight support system the FLOAT on the study participants. The study is~     conducted at the University Hospital Balgrist in Zurich over a period of around 3 years.~     During this time measurements on approximately 120 able bodied subjects and 20 patients with~     an incomplete spinal cord injury will take place. The study participants are invited for a~     single visit of around 140 min duration to the University Hospital Balgrist. During this~     visit the study participants will repeatedly perform various activities of daily living~     (free walking, standing up and sitting down, stair climbing and balancing) with and without~     assistive forces from the body-weight support system. While performing the tasks, the study~     participants' motions and muscle activities will be measured to evaluate the naturalness of~     their movements. In addition, the collected data permits us to compare different movement~     patterns and make conclusions about effective and optimal movement support. Obtaining this~     knowledge will help us to shape the therapy of these activities to be tailored to the~     patients and to train these movements with the help of the FLOAT under optimal conditions.~   "
4056|NCT03004131|"~     This study is to assess the onset of action of fixed drug combination of azelastine~     hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal~     symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an~     Environmental Exposure Chamber (EEC).~   "
4057|NCT03004118|"~     The investigators aim to evaluate ursochol as a therapy in functional dyspepsia. The~     objectives of the study are to evaluate the effect of ursochol on duodenal permeability and~     dyspeptic symptoms and on duodenal low-grade inflammation, bile acid composition, bile acid~     receptor expression, nutrient tolerance and intragastric pressure.~      Cross-over, controlled, randomized, double blinded, placebo-controlled trial with a 4 week~     intake of ursodeoxycholic acid (ursochol) versus a 4 week intake of placebo and a 4 week~     washout period in between. Two study days are planned during week 4 and week 12. During the~     14 weeks, the patients have to fill in a diary. And for 14 weeks in total, the patients have~     to discontinue intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs~     and replace their oral anticonception with non-oral anticonception. Every two weeks of the~     study the investigator will call the participants to see how they are/if they have any~     discomforts or side effects.~   "
4058|NCT03004105|"~     The goal of this clinical research study is to learn if MEDI4736 given in combination with~     selumetinib can help to control advanced lung cancer.~      The safety of this drug combination will also be studied.~   "
4059|NCT03004092|"~     Diagnosis of invasive aspergillosis remains difficult, and is often based on a combination~     of patient characteristics, radiological and microbiological findings. To data,~     galactomannan (GM) is the only well-validated biomarker available. However, GM still has its~     shortcomings. There is therefore a need for new, complementary biomarkers. In this study,~     two of those tests, bis(methylthio)gliotoxin (bmGT) and a lateral flow device, will be~     validated in a hematological population, and compare it to GM.~   "
4060|NCT03004079|"~     The purpose of this study is to assess the relationship of blood glucose levels in persons~     with Multiple Sclerosis (MS) who have experienced a relapse and will be receiving~     intravenous steroids for the relapse, to their recovery from the relapse.~      Steroid exposure commonly leads to elevated serum blood glucose, however, standardized~     monitoring of blood glucose levels in the outpatient setting is not common. The clinical~     impact of any associated elevated blood glucose during steroid administration is unknown. We~     hypothesize that the blood glucose response to steroid treatment is clinically relevant to~     the MS-relapse recovery.~   "
4061|NCT03004066|"~     10 patients with chronic heart failure receiving daptomycin therapy after implantation of a~     left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids~     (mediastinal and pleural drainage systems) and in blood samples.~   "
4062|NCT03004053|"~     The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur~     inside the mouth, using a special camera. These pictures will be used in our research to~     evaluate a new technology that uses a laser and takes pictures of the microscopic structure~     of tissue. The technology is called reflectance confocal microscopy.~   "
4063|NCT03004040|"~     The investigators propose a unique methodology of studying infection and vaccination history~     and immune responses. As most studies in infection history are conducted on mice,~     limitations are inherent on their applicability to humans. A longitudinal comparison study~     following older adults (over the age of 65) hospitalized for influenza are followed through~     to their hospital discharge and vaccination in the following season. This will allow for the~     investigation of the course of infection, as well as impact on the response to vaccination.~   "
4064|NCT03004027|"~     Individuals with visible conditions often report experiencing lowered social confidence and~     encountering intrusive reactions from others, yet relatively few targeted psychosocial self~     help interventions are available.~      The investigators will conduct a randomised controlled trial to compare the efficacy of an~     adapted form of an existing self-help intervention with an enhanced version of the same~     intervention that incorporates if-then planning instructions (or 'implementation~     intentions') and a control condition that will receive support as usual. Participants who~     self-identify as having a visible condition affecting the skin or hair, or scarring to the~     skin that negatively affects their social confidence will be allocated to one of three~     conditions: augmented self-help, standard self help or control. The interventions will be~     delivered online and participants will complete psychometric outcome measures at two time~     points, four weeks apart.~      It is hypothesised that participants who receive the augmented self help intervention will~     have a statistically significant decrease in fear of negative evaluation in comparison to~     both the standard self-help and support as usual control groups.~   "
4066|NCT03004001|"~     The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered~     with atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to~     monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.~   "
4067|NCT03003988|"~     This study was designed to examine how different forms of creatine impact active males.~   "
4068|NCT03003975|"~     This is a clinical study where the investigators will assess the efficacy of a single~     cryoballoon application per vein guided by a multipolar recording catheter as compared with~     a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI)~     in patients with atrial fibrillation (AF).~   "
4070|NCT03003949|"~     Women in the menopause transition ('perimenopause') are exposed to extreme hormone~     variability, tend to experience a unique set of severe stressors (e.g., divorce, death of~     loved ones), and are also at substantially elevated risk to suffer from mood and anxiety~     disorders. The purpose of this research is to understand the mechanisms by which variability~     in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest~     and pleasure - a common symptom of depression). By stabilizing E2 variability with a~     hormonal manipulation, this research will determine the degree to which the E2 variability~     (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and~     whether it does so by affecting biological responses to stress.~   "
4071|NCT03003936|"~     The purpose of this investigation is to assess in a community-based cohort of late-night~     eaters the effect of coincident food intake and endogenous melatonin on glycemic control,~     and the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on~     this relationship. With the results from this study, the investigators expect to advance in~     the understanding of the role of endogenous melatonin on glucose metabolism in late night~     eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines~     to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk~     allele.~   "
4072|NCT03003923|"~     The aim of this cluster randomised control trial is to test the efficacy of a repeated taste~     exposure intervention, a nutritional educational intervention and combination of both to~     increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).~   "
4073|NCT03003910|"~     This study is aimed to test the efficacy of a positive psychological intervention for~     promoting positive emotions and optimistic thinking in eating disordered patients.~     Participants are randomly assigned to receive the positive intervention or the control~     condition, which consists on thinking about daily activities.~   "
4074|NCT03003897|"~     Dietary fiber intake is protective against overweight and obesity; however, a significant~     fiber gap exists between consumption and recommended intake values. Soluble fiber~     beneficially impacts metabolism, and supplementation may be a feasible approach to improve~     body composition and glycemia in overweight and obese individuals. The investigators will~     evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation~     among overweight and obese adults for outcomes related to weight management (e.g. body mass~     index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin~     homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance~     [HOMA-IR], fasting insulin) through systematic review and meta-analysis.~   "
4075|NCT03003884|"~     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a~     procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and~     safety profile comparing to propofol.~   "
4076|NCT03003871|"~     Stroke is the second most common cause of death worldwide and is the predominant cause of~     permanent disability among older people. The mouth becomes a very unhealthy place after~     stroke, where yeasts and pathogenic bacteria multiply at an accelerated rate. Poor oral~     hygiene results in increased dental plaque, gingival bleeding, and the harbouring of oral~     opportunistic pathogens. Dental plaque acts as a reservoir of pathogenic microorganisms~     which results in additional oral health problems and also can cause life-threatening medical~     complications; most notably aspiration pneumonia and/or recurrent stroke. The first six~     months following stroke is a particular vulnerable period to survive.~      Removal of dental plaque and its associated pathogenic microorganisms is challenging in this~     compromised state of reduced manual dexterity and weak state following a stroke. Powered~     (electric) toothbrushes can be of assistance in plaque removal in frail elders. For more~     resistant oral pathogens, anti-plaque/anti-microbial mouthrinses can offer additional help~     in controlling dental plaque and thereby prevent harbouring potentially life threatening~     oral pathogens. Over the years the Faculty of Dentistry and the Stroke Rehabilitation Unit~     of the Department of Medicine in Hong Kong have been actively working together to address~     the problems of oral health associated with stroke; and specifically the challenge of~     safeguarding the life and health of stroke survivors during the vulnerable rehabilitation~     period. We are now proposing to involve stroke patients during out-patient rehabilitation in~     a randomized clinical trial to test the effectiveness of powered tooth brushing and a~     chlorhexidine anti-microbial mouthrinse in reducing dental plaque accumulation and oral~     pathogens; and how this affects their general and oral health status. We anticipate that all~     participants will benefit from the oral health promotion initiatives and that the advantages~     will be long lasting. We expect to demonstrate a 'gold standard' of oral health preventive~     care, as part of stroke rehabilitation, that can reduce (or has potential to reduce) serious~     medical complications after a stroke. If proven effective this oral health preventive care~     regime (which is relatively easy to implement and at low cost) could widely be adopted in~     stroke rehabilitation globally.~   "
4077|NCT03003858|"~     The purpose of this observational, non-controlled, single site trial with a retrospective~     design is to verify, in a large paediatric population affected by gingivitis, the~     tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid,~     Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to~     domiciliary care and oral hygiene instructions~   "
4078|NCT03003845|"~     For each patient in the study, blood, and pain scores will be collected to look for markers~     for pain, at the start of treatment and 6 months after surgery of treatment.~   "
4079|NCT03003832|"~     The goal of this research is to investigate the impact of changing opioid analgesic~     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in~     adult primary care and emergency department settings. We will change prescribing defaults~     for select short-acting opioid analgesics including immediate release oxycodone and~     hydrocodone as well as codeine and tramadol, including their co-formulations with~     acetaminophen. In a cluster-randomized trial of matched pairs of Montefiore Medical Center~     clinical sites, stratified by specialty and teaching status, we will evaluate the impact of~     this intervention on patient-level outcomes using 18 months of data (6 months~     pre-intervention and 12 months post-intervention).~   "
4080|NCT03003819|"~     A prospective RCT of intact extractions with delayed implant placement comparing extraction~     socket management effectiveness and office economics of two collagen matrices. Soft tissue~     wound healing will be assessed out to 4-months post-operative, when implants will be placed.~   "
4092|NCT03003741|"~     There is a new form of bupivacaine, called Exparel, which can be injected into the eye~     socket during surgery and may provide pain relief for up to 72 hours. The purpose of the~     study is to compare the plain bupivacaine injection to Exparel, to see if one medication~     works better than the other.~   "
4121|NCT03003364|"~     This is a phase I/IIa, randomized, double-blind, single-dose, placebo controlled, two-way~     crossover clinical trial in which 10 patients from 18 to 65 years of age affected with~     chronic traumatic spinal cord will enter the study with the objective to assess the safety~     and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly~     mesenchymal stem cells.~   "
4081|NCT03003806|"~     The DreaMed Advice4U Pro is a software which automatically analyses treatment information,~     learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed~     Advice4U Pro uses information gathered from glucose monitoring (sensor readings or capillary~     blood glucose measurements), insulin dosing and meal data during daily routine home care.~     Following a 5-minute data collection and analysis, the algorithm learns and suggests~     pump-setting changes for optimization of glucose control~      The algorithm is designed as an advisory tool and has three main components:~        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,~          bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia~          patterns.~        2. Practical recommendations, alert messages based on aforementioned data~        3. Recommendation for new insulin pump settings: including basal intervals and rate,~          different carbohydrate ratio according to time of day, correction factor and insulin~          sensitivity time.~      The main goal of the DreaMed Advice4U Pro is to improve diabetes management for subjects~     with Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for~     pump users.~      The main objective of the proposed study is to evaluate the safety and efficacy of using the~     DreaMed Advice4U Pro algorithm versus medical guided recommendation to determine insulin~     dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.~   "
4082|NCT03003793|"~     The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over~     many years. Novel research shows an association between the two conditions. While this~     relationship at least in theory can be explained by lifestyle factors, there is reason to~     believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that~     patients with atopic dermatitis are insulin resistant due to their chronic inflammatory~     state. Insulin resistance might play an unknown part in the increased frequency of type 2~     diabetes among patients with atopic dermatitis. In the present project, the investigators~     aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic~     euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control~     group (matched case-control study). The project is a close collaboration between The~     Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.~   "
4083|NCT03003780|"~     This is a developmental project with two phases. The first phase will adapt an existing~     web-based intervention to incorporate mind-body exercises to develop a multi-modal~     intervention to promote physical activity in patients with COPD and HF. The second phase~     will pilot test this new intervention in a longitudinal study (subjects randomized to~     intervention or usual care).~   "
4084|NCT03002727|"~     Microsatellite instability is more common in colorectal cancer ( CRC) young patient which is~     associated with good prognosis and is considered as a predictor for good response to~     preoperative chemoradiotherapy. Counting of ( cluster of differentiation) CD 133 +ve cells~     ,as a marker for enrichment with colorectal cancer stem cells ,is considered as a prognostic~     marker for poor survival and predictor for radio-resistance. Correlation between~     microsatellite status ( MS) and CD133 count has not yet studied especially in young patients~     with rectosigmoid cancer. So the investigators hypothesize that there is correlation between~     microsatellite status, CD133+ve cells count , occurrence of CRC in young patients and~     resistance to standard treatment regimen. Improvement of response to treatment and choice of~     the best regime to avoid non beneficial treatment modality are the goal of this study.~   "
4085|NCT03002714|"~     The purpose of this study is to determine and compare the effects of two sessions of~     resistance exercise in blood pressure reactivity to a mental stress test in older~     hypertensive women.~   "
4086|NCT03002701|"~     Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with~     serious short- and long-term consequences. This study focuses on a program of standardized~     nursing and physical therapy interventions to prevent delirium in the ICU, and determines~     the effect of the program on the number of delirium-coma-free days in 28 days and several~     secondary outcomes in a multicenter randomized controlled trial.~   "
4087|NCT03002688|"~     The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract~     surgeries to assess if the second experience of cataract surgery differs from the initial~     experience.~   "
4088|NCT03002675|"~     The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes~     mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who~     comprise 1/5 of the world population, are at increased risk of developing a disadvantageous~     metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower~     BMI when compared to white Caucasians. Recent research has shown that South Asians not only~     have a lower energy expenditure than their Caucasian counterparts, but also less active~     brown adipose tissue (BAT).~      For some time, it has been known that adult humans have active BAT. This metabolic tissue~     produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores~     this form of energy. It has been shown that activation of BAT has a positive effect on whole~     body metabolism, via increasing energy expenditure and improving glucose- and lipid~     metabolism. For this matter, BAT has been proposed as a major key player in energy~     homeostasis, which may be implemented in the current combat against the obesity epidemic.~     Aside from cold exposure, more research focuses on pharmacological activation of BAT.~      Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal~     L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The~     GLP-1 analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia~     via this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has~     also shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the~     underlying mechanism of these beneficial effects is highly relevant.~      Recent preclinical research in our group has shown that central activation of the GLP-1~     receptor through exenatide increases BAT activity and thereby contributes to weight loss and~     improvement of dyslipidemia. The aim of this research project is to investigate whether~     exenatide is also able to activate BAT and increase resting energy expenditure, thereby~     improving glucose- and lipid metabolism and reducing fat mass and body weight in humans.~     Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT~     activity. The investigators hope that these forthcoming findings lead to the discovery of~     new treatment strategies against obesity.~   "
4089|NCT03002662|"~     During colonoscopy, body mass index, waist circumference and waist / hip ratio is the~     relationship between the cecal intubation difficulty aims to define.~   "
4090|NCT03002649|"~     The purpose of this study is to obtain preliminary data regarding the safety and efficacy of~     Janus kinase (JAK) inhibitor, tofacitinib, in adults with active, treatment-refractory~     dermatomyositis.~   "
4091|NCT03003754|"~     Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a~     wide interindividual variability after exercise training explored mainly in adults but not~     in children. Thus, is yet unknown what baseline health status as well as the influence of~     what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage~     of subjects who experienced a non-change/worsened response after training in some metabolic~     outcomes) after exercise training in school children.~   "
4093|NCT03003728|"~     This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat~     multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem~     cell transplant. Natural killer cells are a special type of white blood cells that are~     already present in the body which have the ability to kill myeloma cells. In this study,~     natural killer cells will be collected and then treated in a laboratory to activate and~     'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells~     before they are transfused back into the subject. Elotuzumab is a protein drug approved by~     the United States Food and Drug Administration (FDA) for patients with previously treated~     multiple myeloma and works by activating natural killer cells already present in the body~     and targeting a protein called SLAMF7 which is present on both natural killer cells and~     myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK~     cells will enhance the anti-myeloma activity of the ENK cells.~   "
4094|NCT03003715|"~     The main goal of this study to integrate techniques producing images of the brain (also~     called neuroimaging techniques) with non-invasive brain stimulation to investigate factors~     that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).~   "
4095|NCT03003702|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs~     that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in~     activities, patients are prone to developing chest infections called 'exacerbations'.~     Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to~     cause hospital admission (and therefore health facilities pressures) and death. Reducing the~     impact of exacerbations is very important. We have previously shown that earlier treatment~     of COPD exacerbations results in faster recovery, and reduced chance of hospital admission.~     Helping patients to detect exacerbations early is therefore important. We have also recently~     shown that monitoring heart rate and oxygen saturation via a finger probe may assist in~     this. However, measuring these variables when the patient is awake means they can be~     affected by other things, such as exercise and anxiety. Our new idea is that measuring heart~     rate and oxygen level overnight, when a patient is asleep, will give the best chance of~     detecting COPD exacerbations early and our study will test that. We will randomly allocate~     64 patients with COPD recruited from our service in London to standard monitoring, or~     overnight monitoring, for up to six months or the first exacerbation, whichever is sooner.~     We will then analyse whether overnight monitoring was able to detect exacerbations earlier,~     and therefore could be used to help patients get treatment earlier. A subset of participants~     will also wear an activity monitor overnight for the first two weeks, so that we can assess~     the effect (if any) of overnight awake periods (such as trips to the bathroom) on the heart~     rate and saturation recording.~   "
4096|NCT03003689|"~     Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal~     (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque~     is critical for improving the periodontal health. The standard initial treatment of~     periodontitis (gum disease) is to remove plaque and calculus form the teeth and root~     structures using sclaing and root planing (SRP). Typically hand instruments and an~     ultrasonic scaler are used for SRP~      While this method removes some of the bacteria that leads to periodontitis, microorganisms~     are not completely eliminated through SRP. Studies have shown that after 3 months, the~     bacteria initially present prior to scaling and root planing had recolonized. In order to~     prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low~     levels.~      When used at the proper wave length, dental lasers have been shown to effectively removes~     calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for~     the use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have~     shown that it is effective in removing calculus and preserving the tooth root structure,~     there is no consensus of the level of calculus removal. The Er:YAG laser may also be more~     effective in removing microbial bacteria than SRP with hand instruments and ultrasonic~     scaler.~      The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an~     adjunct to scaling and root planing, in removing microbial bacteria. Participants with~     chronic periodontitis will be randomized to have one quadrant undergo scaling and root~     planing using hand instruments and ultrasonic scaler alone, while a second quadrant will~     receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be~     traditional periodontal clinical parameters at 6 weeks and 3 months after treatment.~     Microbial cultures will be performed at baseline and 3 months to compare survival and~     re-population by periodontal microorganisms.~   "
4097|NCT03003676|"~     This is a single center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in~     patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary~     objective of the study is to determine the safety of sequential treatment with ONCOS-102~     followed by pembrolizumab. The protocol aims to enroll 6 patients into each of two cohorts:~     prior PD1 monotherapy or prior combination PD1 plus ipilimumab combination therapy.~   "
4098|NCT03003663|"~     The purpose of this study is to determine the effect of an Internet-of-Things bed fall~     solution when used in a hospital setting.~   "
4099|NCT03003650|"~     First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in~     Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the~     safety and performance of the device.~   "
4100|NCT03003637|"~     This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1~     with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and~     neck squamous cell carcinoma (HNSCC), a patient population in need for improved clinical~     outcome and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with~     this research protocol the potential impact of intratumoral hypoxia on tumor infiltrating~     lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the~     potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and~     normoxia.~   "
4101|NCT03003624|"~     The aim of the present study was to compare the outcomes of incisions made by Colorado®~     microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.~   "
4102|NCT03003611|"~     The investigators will compare the operated patients for a beginning breast cancer in the~     Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational~     study as we cannot randomized patient, (they need to be compliant with Hypnose).~      Patient will be informed that some parameters, about his recovery, will be collected from~     their medical file. They will not have another particular treatment because they are in the~     study. It is just a prospective data collection.~      The patient will be compared on several items after the surgery ( as pain and pain killer~     intake, the heal process of the scar, etc...) Also the investigators will compare the impact~     of hypnose on the other treatments the patient received.~      The investigators need approximately 150 patients (Half in each arm).~   "
4103|NCT03003598|"~     In this study, the investigators aimed to compare the effects of endotracheal intubation via~     direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.~   "
4105|NCT03003572|"~     Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to~     life-threatening conditions and is always responsible for a decreased quality of life. Its~     evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be~     carried out routinely is major in patients' follow-up. Because of the existence of~     autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for~     anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific~     pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to~     determine pSS's activity. The aim of the study is to evaluate whether the proportion of~     anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular~     Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or~     already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the~     disease's features will be collected (including Eular Sjögren Syndrome Disease Activity~     Index/Eular Sjogren's Syndrome Patient Reported Index).~   "
4106|NCT03003559|"~     For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive~     pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild~     AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we~     design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal~     cannula to prevent the aggravation of respiratory failure and endotracheal intubation in~     mild AECOPD.~   "
4107|NCT03003546|"~     This phase I trial studies the best dose and side effects of AR160 in treating patients with~     B-cell non-Hodgkin lymphoma that has come back or is not responding to treatment. AR160 is a~     combination of paclitaxel albumin-stabilized nanoparticle formulation and rituximab. Drugs~     used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such~     as rituximab, may interfere with the ability of tumor cells to grow and spread. Giving~     paclitaxel albumin-stabilized nanoparticle formulation and rituximab may work better in~     treating patients with B-cell non-Hodgkin lymphoma.~   "
4108|NCT03003533|"~     This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the~     safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals~     with hemophilia A.~   "
4109|NCT03003520|"~     This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical~     activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumab in~     combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation~     therapy in previously untreated subjects with high-risk DLBCL.~      Patients with non-ABC subtype (determined by gene expression profiling) will be allocated to~     Arm A while patients with ABC (activated B-cell type) subtype will be allocated to Arm B.~     Approximately 120 patients may be enrolled and assigned into the appropriate treatment arms~     dependent upon their cell of origin status.~      Induction treatment with R-CHOP (± Lenalidomide) will last for a total of up to 6 to 8~     treatment cycles (21 days cycle), and the total time on study treatment, including~     durvalumab consolidation, will last up to 12 months.~   "
4110|NCT03003507|"~     Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these~     patients receive enteral feeding. There is controversy about ideal carbohydrate composition~     of these diets. The aim of this study was to compare an enteral formula with the same~     proportion of carbohydrates with and without fructose on blood glucose levels.~   "
4111|NCT03003494|"~     The purpose of the study is to measure changes in physical functioning in chronic~     obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after~     approximately 6 weeks in routine clinical practice.~   "
4112|NCT03003481|"~     Collect patient data and to monitor the clinical use (safety and efficacy) of the device~   "
4113|NCT03003468|"~     This is an open label, multi-institutional, single arm study with a dose escalation phase Ib~     cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or~     blinding is involved.~   "
4114|NCT03003455|"~     The purpose of this study is to determine whether nasal intubation over a bougie placed via~     a nasal trumpet will decrease nasal trauma when compared to the conventional technique of~     blind nasal endotracheal tube passage.~   "
4115|NCT03003442|"~     Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective~     ratings of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a~     consequence of exercise and metabolically demanding cognitive tasks.~   "
4116|NCT03003429|"~     The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the~     model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the~     parasympathetic nervous system and a decrease of the sympathetic system. Various~     explanations of this these dysfunctions are proposed in literature, mainly malnutrition,~     physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.~      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety~     in anorexia nervosa.~      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction~     and others parameters (weight, body mass index, depression, physical activity, purgative ou~     restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if~     HRV is a predictive parameter of the evolution of anorexia nervosa.~   "
4117|NCT03003416|"~     This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in~     France for the treatment of Diabetic Macular Edema (DME).~   "
4118|NCT03003403|"~     Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical~     practice guidelines clearly recommend that these patients avoid gaining weight. However,~     despite this clinical guideline, weight gain prevention interventions are not available in~     primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for~     weight gain prevention for patients within rural community health centers, using a digital~     health platform.~   "
4119|NCT03003390|"~     The purpose of this phase 2a, multi-center, single arm study, is to explore the efficacy of~     early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically~     ill children.~   "
4120|NCT03003377|"~     The study was designed to determine and compare the sevoflurane EC50 optimal concentration~     for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during~     target-controlled infusion of remifentanil.~   "
4122|NCT03003351|"~     This is a pro- and retrospective cohort study to evaluate the natural history and outcome of~     various treatment options of patients with fistula. At each clinical visit parameters~     describing activity of a fistula, potential underlying Crohn's disease, investigations as~     well as the current treatment will be entered into a database. Selected patients can also be~     contacted by phone in the form of a structured interview. Data will be analyzed to determine~     treatment outcomes, characterize the natural history as well as risk factors for~     complications of treatment and an unfavorable disease course. The same data will be obtained~     and analyzed retrospectively from patients who visited the clinic prior to January 2017.~   "
4123|NCT03003338|"~     This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to~     investigate whether a successful interferon-free treatment of HCV-infection with~     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves~     the patients' attention ability as compared to placebo as measured with the Att Test Sum~     Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b~     HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks~     Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be~     followed up for 48 weeks.~   "
4124|NCT03003325|"~     The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the~     addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy~     available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the~     efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years~     and without prior vascular events), in term of control of recommended level of hematocrit <~     45%, over a period of 12 months.~   "
4125|NCT03003312|"~     Objective:The aim of this study is to investigate the prevalence and associated factors of~     pediatric urolithiasis in Kashgar area in China.~      Methods: The investigators carry out a cross-sectional survey among children aged 0 to14~     years across Kashgar area in China. The participants are selected by a two-stage and~     clustered random sampling method. Participants are asked to undergo urinary tract~     ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or~     guardians are asked to fill out the questionnaires. Children those who are found with any~     abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed~     tomography (CT) to confirm the abnormalities. The end point of this study is to calculate~     the prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi~     area.~   "
4126|NCT03003299|"~     To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,~     California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.~   "
4127|NCT03003286|"~     The purpose of this study is to determine whether a new treatment, Unstuck and On Target~     (UOT), works better, worse, or the same as the best treatment that is available now,~     Contingency Behavioral Management (CBM), for low income children with Autism Spectrum~     Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Researchers predict that~     UOT will be better than CBM for children with ASD and ADHD at improving cognitive problem~     solving, executive functioning, self-control and use of medical care, but equal to CBM at~     improving behavior and coping.~   "
4128|NCT03003273|"~     Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with~     low risk features (culture awaited), will be started on intravenous antibiotics (Inj~     Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed~     for randomization once they fulfill all inclusion criteria and get afebrile for at least 24~     hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous~     antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or~     reappearance of fever within follow-up of ≤ 10 days.~   "
4129|NCT03003260|"~     Rationale: IBS is the most common functional gastrointestinal disorder with a prevalence~     worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered~     bowel habits. Although the condition is not life-threatening, it strongly impairs quality of~     life and up to now there is no cure for IBS. It is assumed that IBS symptoms are related to~     a combination of altered gut motility and secretion, and visceral hypersensitivity. However,~     its primary cause still remains largely unknown. The endocannabinoid system, together with~     some functionally related receptors is among the biological targets considered promising for~     treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the~     endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally~     related lipid mediators can influence motility, secretions and decrease hypersensitivity in~     the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol~     (CBD) is of special interest as it has shown therapeutic potential in preclinical studies~     and a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a~     broad but weak receptor interaction profile. In contrast to the well-known THC from Cannabis~     sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are~     not used for their psychoactive properties but for industrial (fibre) or food properties~     (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we~     hypothesize that CBD might be able to relieve symptoms of IBS, including pain in patients~     with IBS. The chewing gum is to be taken 'on demand' and may have some additional perceived~     positive effects.~      Objective: To investigate whether the use of a CBD-containing preparation in the form of~     CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of~     perceived wellbeing in patients with IBS.~      Study design: A randomized, double-blind, cross-over trial of 8 weeks in total.~      Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with~     Irritable Bowel Syndrome.~      Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6~     chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the~     CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3~     weeks. Next, participants will undergo a one week wash-out and then switch intervention to~     either placebo or the CanChew chewing gum for another 3 weeks.~      Main study parameters/endpoints: The main study parameter is a change in pain reduction~     perception experienced and measured by the patient using VAS-scales before and after taking~     the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one~     VAS score for each completed week. Furthermore, the adequate relief will be measured every~     day. At the end of each week patients will also be asked (from their diary) whether they~     noticed a change in stool frequency or (and) experienced any side-effects. For the~     disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled~     out in week 1, 4, 5, and 8.~   "
4130|NCT03003247|"~     Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris~   "
4131|NCT03003234|"~     Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function.~     Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological~     mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown.~     In this study, we evaluated whether the luminal bile salt content could play a role in~     impaired duodenal permeability in FD.~      Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies~     were mounted in Ussing chambers to measure transepithelial resistance (TEER) and~     paracellular permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa).~     Expression of bile acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies~     was measured by western blot and real time RT-PCR. Immunohistochemistry was used to evaluate~     eosinophil and mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal~     fluid aspirates were collected at fixed time points during 1 hour in fasted state and 1.5~     hours after a liquid meal (Nutridrink, 200ml). Concentration and composition of the bile~     salt pool (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic~     acid (GCDC), taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC),~     taurodeoxycholic acid (TDC), glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid~     (TUDC)) in these aspirates was evaluated by liquid chromatography-mass spectrometry-selected~     ion monitoring analysis (LC-MS/MS).~   "
4132|NCT03003221|"~     Participation in routine dental care is a significant challenge for children with autism~     spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD~     symptoms and associated anxiety and behavioral challenges. Lack of routine, effective dental~     care has contributed to a substantial unmet healthcare need for children with ASD, who are~     at increased risk for excessive plaque, caries, and oral infections.~      The purpose of this study is to test a parent-training intervention designed to improve home~     dental hygiene, compliance with dental office visits, and oral health outcomes in children~     with autism spectrum disorder. Families of children ages 3 to 13 years with an existing~     diagnosis of ASD will be recruited for participation. All families will receive the Autism~     Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed~     to provide parents with guidance and information about dental care and support strategies~     for children with ASD. Some families will also participate in a 10-week behavioral~     parent-training intervention focused on improving home dental care and dental office visit~     experiences.~      The study has three primary aims: 1) To improve children's functional and behavioral~     compliance with home dental hygiene, 2) To improve children's oral health, and 3) To reduce~     child anxiety and improve compliance with dental visits.~   "
4133|NCT03003208|"~     Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.~     Patients with COPD are at increased risk of developing cardiovascular disease such as heart~     attacks and strokes. A simple measurement called arterial stiffness is a good assessment of~     how likely people are to have cardiovascular disease, both in healthy populations and those~     with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness,~      Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is~     an effective intervention in COPD to reduce symptoms, improve exercise performance and~     prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is~     controversial as two small positive studies suggested benefit and one larger study did not.~      Investigators have recently shown that cardiovascular risk is higher in those COPD patients~     who get the most infections (exacerbations). PR is an effective intervention for preventing~     COPD exacerbations. Logically, the exercise component would be expected to reduce~     cardiovascular risk too.~      Investigators want to identify which patients with COPD get cardiovascular benefit from a PR~     programme and why others do not. Investigators propose to measure aPWV before and after PR.~     Investigators will then classify participants as responders or non-responders defined as the~     presence or absence of a significant improvement in aPWV. Investigators will be collecting~     demographic and clinical information including daily physical activity level and how~     effective the PR has been to enable the investigators to identify the characteristics of~     patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD.~     This will inform on better design of PR programmes for people living with COPD.~   "
4134|NCT03003195|"~     The purpose of this research is to compare the effects of using a new experimental vaccine~     with standard treatment in treating metastatic cancer.~   "
4135|NCT03003182|"~     This prospective cohort study aims to establish prognostic models, to discover toxicity~     associated predictors and to validate randomized trials in clinical practice.~   "
4136|NCT03003169|"~     This is a prospective observational study, involving 550 mastectomies in Lorraine Institute~     of Oncology, to assess care patients management of ambulatory surgical compared to standard~     surgery procedure.~   "
4137|NCT03003156|"~     This trial attempts to investigate whether the dosage (frequency) has an effect on the~     treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among~     schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,~     while the other half will be recruited to 50 Hz MST.~   "
4138|NCT03003143|"~     Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients~   "
4139|NCT03003130|"~     This is a randomized, split face, multicenter study to evaluate the efficacy and safety of~     Restylane Defyne compared to Restylane in correction of NLFs.~   "
4140|NCT03003117|"~     The purpose of this study is to conduct a randomized controlled trial among 800 socially~     disadvantaged pregnant women and their families to test the effectiveness of a~     multi-component home visitation nutrition program, compared to usual care, in promoting~     healthy feeding practices and growth in young children.~   "
4141|NCT03003104|"~     The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied~     twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of~     participants will receive DMT210 Gel while the other half will receive vehicle control.~   "
4142|NCT03003091|"~     In patient education, the amount of information that is not proper with the individual~     patient, such as too much or too little, can increase anxiety to patient. Needs-based~     patient education has been developed to determine the proper amount of information and~     provide the education based on patient needs. This study aims to compare needs-based patient~     education to traditional patient education in how they affect preoperative anxiety and~     patient satisfaction.~   "
4143|NCT03003078|"~     The purpose of this research study is to investigate the safety of an active implantable~     (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer,~     in conjunction with Standard of Care (SOC)chemotherapy. OncoSil™, is an experimental~     treatment and carries the active treatment radioactive Phosphorous (32P) inside inactive~     silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour~     permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a~     targeted tumour to destroy cancer cells. Patients will be taking part in a single arm open~     label research study - which means that everyone in the research study will receive the~     investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen~     which will be either; FOLFIRINOX (FOLFIRINOX is the name of a combination of chemotherapy~     drugs used to treat advanced cancer of the pancreas) or gemcitabine + nab-paclitaxel~     (Abraxane).Participation in this research study involves a Screening Period, a Treatment~     Follow Up Period and a Long Term follow up period. At the first screening visit, every~     patient will be asked to sign a consent form to agree to the study procedures, before any~     assessments are performed for the study. The total number of visits patients will need to~     attend will depend on how long it takes for their disease to progress. The implantation of~     OncoSil™ will be completed in the endoscopy suite of the hospital under endoscopic~     ultrasound. This allows the specialist doctor to view the pancreas and enables them to~     implant the OncoSil Microparticles via a fine needle directly into the target tumour. After~     the procedure, there will be a 4 hour observation period to ensure that the patient is~     feeling fine and safe to go home. Implantation will only occur once during the treatment~     period, and once implanted, the device cannot be removed. After the patients target tumour~     shows progression on imaging, there will be an end of study visit and then the Long Term~     follow up period will be conducted. The Long Term Follow up does not require the patient to~     return to the research study site, it is done via review of the patient's medical records by~     site staff every 8 weeks for a maximum of up to 30 months.~   "
4144|NCT03003065|"~     In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents~     in patients with inoperable bile duct cancers. In addition as a preliminary study we sought~     to determine if the treatment can reduce tumor volume in the short term.~   "
4145|NCT03003052|"~     This purpose of this database is to collect, store and use appropriately derived data from~     routine patient care in a specialist dental practice. Comprehensive observational data will~     be gathered, systematically organised and be continuously updated. This data will be used to~     evaluate treatment outcomes and identify areas for improvement. This will contribute to the~     existing evidence base to validate new and current clinical concepts in dentistry. Patient~     consent will be sought for this, and all data extracted from patient notes will be stored~     and used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and~     post treatment will be used to assess patient satisfaction with outcomes.~   "
4146|NCT03003039|"~     The purpose of this study is the area under the curve (AUC) for GB241 and rituximab~     concentrations.~   "
4163|NCT03002818|"~     This is an observational, prospective, open-label, single-arm, multicenter, real-life study~     designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen~     (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in~     participants with Hepatitis C Virus (HCV) genotype 1 (GT1).~   "
4147|NCT03003026|"~     An assessor blinded multi-centre randomized controlled trial will be conducted in which 60~     participants will be randomized to either a novel task-specific approach to training bike~     skills or a parent-led home program comparison group. Baseline assessment will take place~     within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within~     a week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The~     primary outcome is attainment of individualised two-wheel bike specific goals at T1. All~     statistical analysis will be conducted on an intention-to-treat basis. Logistic regression~     will be used to assess the effect of providing the novel intervention compared to the~     parent-led home program on bike-specific goal attainment.~   "
4148|NCT03003013|"~     Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich~     fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical~     trial~   "
4149|NCT03003000|"~     To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison~     to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess~     the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a~     400 mg ibuprofen tablet and a placebo tablet.~   "
4150|NCT03002987|"~     In a cluster randomized design it will be investigated whether teaching local leaders how to~     implement active pregnancy policy results in less sickness absence among their pregnant~     employees. Further it will be investigated to what extent Active pregnancy policy is~     implemented at the departments and whether it results in higher sense of security and~     wellbeing among the pregnant employee. Finally the cost and benefits of the intervention~     will be analyzed.~   "
4151|NCT03002974|"~     The purpose of this study is to evaluate how anakinra relieves pain for patients with acute~     gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The~     patients will be divided in different treatment groups to compare anakinra to the available~     drug triamcinolone.~   "
4152|NCT03002961|"~     A multi-center, open-label, single ascending dose study to enroll opioid dependent~     treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and~     high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of~     RBP-6000 after receiving suboxone tablets for 7 days.~   "
4153|NCT03002948|"~     Topography and location of clitoris and its parts may affect the orgasm~   "
4154|NCT03002935|"~     This is an open-label, Phase I study of the bioavailability and safety of BPM31510~     administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose~     is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.~   "
4155|NCT03002922|"~     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after~     exercise compared to the full coverage observed prior to exercise~   "
4156|NCT03002909|"~     the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine~     wound infiltration versus epidural analgesia on the inflammatory cytokines response after~     abdominal cancer surgery~   "
4157|NCT03002896|"~     The proposed project is a pilot randomized control trial of the Pep-Pal (Psychoeducation and~     Skills Based Intervention) versus a treatment as usual control group. A total of 120~     caregivers; 40 caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation),~     40 caregivers of patients enrolled in phase I oncology trials, and 40 caregivers of patients~     with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The~     investigators do not expect different outcomes from these three groups, rather these~     populations are selected to optimize recruitment within a short time frame. The caregivers~     will be randomized to either treatment as usual or Pep-Pal intervention.~   "
4158|NCT03002883|"~     Community colleges have 45% of the nation's undergraduates and have a higher smoking~     prevalence rate than 4-year colleges. California's community colleges comprise the nation's~     largest higher education system, and Sacramento has the second largest community college~     district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers~     enrolled at community college campuses need greater support. However, community colleges may~     lack the student health clinic resources that 4-year colleges have for students who live on~     campus. Little evidence to date demonstrates effective interventions for smokers on~     community college campuses.~      This pilot study seeks to demonstrate the feasibility and promising outcomes of two~     cessation interventions, compared with usual care on a community college campus. The first~     intervention was based on a promising model of brief motivational interviewing delivered by~     peer educators, developed by the community lead Breathe California of Sacramento-Emigrant~     Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND)~     project. The second intervention was based on direct enrollment into the California Smokers'~     Helpline, which has demonstrated utility for promoting smoking cessation among young adults~     with low socioeconomic status. Usual care consisted of students going to the student health~     center for smoking cessation assistance.~   "
4159|NCT03002870|"~     The purpose of this study is to collect and analyze data on the characteristics of women who~     are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as~     part of their standard medical care. Data collected will contribute to the development of~     guidelines for the surgical management of endometriosis. In addition, specimens will be~     collected for future testing regarding diagnosing, and/or staging of endometriosis, or~     suspected endometriosis, pain and infertility.~   "
4160|NCT03002857|"~     The most used airway management strategies are different types of supraglottic airway~     devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery~     . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of~     this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®~     with I-gel and LMA-C regarding their insertion times, durations, perioperative complications~     and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato~     pressures in urological surgery as well.~   "
4161|NCT03002844|"~     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in~     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use~     EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients~     with both EGFR mutation and BIM deletion polymorphism.~   "
4162|NCT03002831|"~     The purpose of this study is to determine whether Cytokine induced killer cells combined~     chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.~   "
4164|NCT03002805|"~     This study evaluates the combination of CBT-1® and doxorubicin for the treatment of~     metastatic, unresectable sarcoma in patients who have progressed after treatment with~     150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day~     cycle, as well as doxorubicin on days 5 and 6.~   "
4165|NCT03002792|"~     The purpose of this study is to investigate whether early expose to general anaesthesia will~     influence neurodevelopment.~   "
4166|NCT03002779|"~     The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its~     metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the~     chemical structure of predominant metabolites in healthy adult male participants after a~     single oral dose of 500 milligram (mg) 14C-JNJ-53718678.~   "
4167|NCT03002766|"~     By this non-randomized prospective study, it's evaluated the outcome of patients underwent~     BCS for DCIS at whom an established score system to address adjuvant therapies have been~     prospectively applied, according to the wideness of free margins.~      Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.~   "
4168|NCT03002753|"~     The purpose of this study is to assess and compare the overall efficacy and differential~     effects of detached mindfulness and cognitive restructuring in the treatment of patients~     with obsessive-compulsive disorder.~   "
4169|NCT03002740|"~     In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with~     oral anticoagulants (OAC) in routine clinical practice in England, this study will describe~     patients treated with each OAC, and to estimate and compare event rates of treatment~     discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.~   "
4170|NCT03002636|"~     900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia~     included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were~     divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 ,~     severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with~     BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women~     met inclusion criteria and 900 women received allocated intervention. All patients were~     divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and~     non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40~     kg/m2 and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.~   "
4171|NCT03002623|"~     Background:~      The thyroid is a gland at the base of the throat. Thyroid cancer is a disease that people~     get when abnormal cells begin to grow in this gland. Researchers believe a new drug called~     CUDC-907 may be able to help people with thyroid cancer that has spread or has gotten worse.~      Objective:~      To see if CUDC-907 will shrink tumors in people with advanced thyroid cancer.~      Eligibility:~      People at least 18 years old who have been diagnosed with locally advanced and metastatic~     thyroid cancer.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Electrocardiogram (ECG) heart test.~      Review of their symptoms and how they perform normal activities~      A scan will be performed. Some will have a computed tomographic scan (CT) that takes~     pictures of the body using a small amount of radiation. Some will have magnetic resonance~     imaging (MRI) that uses a magnetic field to take pictures.~      Bone scan (some participants)~      FDG PET scan to produce a tumor image.~      A sample of their tumor from a previous surgery. They may have a biopsy of their tumor if a~     tumor sample is not available from a previous surgery.~      Participants will be given CUDC-907 in tablet form. They will take it by mouth once a day~     for 5 days, then take 2 days off, each week.~      While taking the study drug, participants will have study visits that repeat the screening~     tests.~      After they stop treatment, participants will have 3 follow-up visits over a year. They will~     repeat some tests. Then participants will be contacted by phone or e-mail every 6 months....~   "
4172|NCT03002610|"~     The objective of this study is to evaluate the efficacy of infographics, compared to~     standard PLS and scientific abstract format, in presenting information, in terms of~     understanding and remembering research results by physicians.~   "
4173|NCT03002597|"~     The BrainPort vision device is a visual prosthetic designed for those who are blind. It~     enables perception of visual information using the tongue and camera system as a paired~     substitute for the eye. Visual information is collected from a video camera and translated~     into a gentle vibration that is presented to the subject on the tongue. With training users~     perceive shape, size, location and motion of objects in their environment. It is a~     functional, non-surgical device developed to demonstrate as an aid to the visually impaired.~      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision~     device) that enables the blind to appreciate their immediate surroundings and determine the~     way the brain interprets the information. Our goal is to determine if the device can be used~     in a pediatric population by measuring the subjects' improvement over baseline in any of the~     following areas: light detection, light localization, movement perception, and standardized~     object recognition tasks after use of the BrainPort.~   "
4174|NCT03002584|"~     Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)~     in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both~     complaining of Gas-Related Symptoms (GRS).~      IGQ has been developed previously simultaneously in UK English, French and Spanish through~     qualitative research with subject interviews. The conceptual framework of the IGQ assesses~     both GRS and their impact on daily life. Similar concepts were identified for both subjects~     with IBS diagnosis and general population and complaining of gas-related symptoms.~      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17~     items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26~     items)~   "
4175|NCT03002571|"~     Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic~     Dermatitis in Pediatric and Adult Subjects~   "
4206|NCT03002168|"~     The Investigator hypothesizes that the currently used dose of dietary ingredient~     alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared~     with placebo. The proposed studies will address the degree to which α-CD increases dietary~     fat loss.~      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,~     Minnesota.~   "
22918|NCT02757196|"~     a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial~     performed in 5 departments of hematology in China~   "
4176|NCT03002558|"~     Objectives:~      Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on~     cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension~     (RH).~      Secondary objectives: i) to identify the subclinical organ damage profile at baseline and~     its association with OSA, and to identify if long term blood pressure control and number of~     antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii)~     to identify epigenetic profiles and clinical, biological and polygraphic variables with a~     predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the~     HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in~     women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA~     diagnosis and treatment in patients with RH.~      Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood~     pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and~     subclinical organ damage variables and biological samples at baseline will be collected from~     all the subjects included. A sleep study will be performed in all the subjects at the study~     inclusion date. Subsequently, the OSA subjects will be managed as per local standard~     practice. Follow-up variables will be annually collected (including blood samples). On the~     basis of OSA and its treatment, three cohorts of RH subjects will be defined: control~     (non-OSA), OSA-treated and OSA nontreated.~   "
4177|NCT03002545|"~     This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium~     from organic magnesium citrate affects blood glucose control and insulin resistance within~     patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive~     transporting genes is affected .~   "
4178|NCT03002532|"~     Based on evidence that radiation-induced damage to the hippocampus plays a considerable role~     in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain~     radiation therapy (HS-WBRT) has been proposed. This study will investigate the~     neurocognitive function and prognosis between HS-WBRT and conventional WBRT for the~     treatment of brain metastases from breast cancer.~   "
4179|NCT03002519|"~     This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in~     subjects with incomplete hematopoietic recovery following HCT.~   "
4180|NCT03002506|"~     This study will help provide information about how patients with burn handle two antibiotics~     (ceftolozane and tazobactam) and use that information to guide dosing recommendations for~     these patients. The 12 patients who complete the study will receive a single dose of 3 grams~     ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine~     how much of each antibiotic is in the body and urine at various times over a 24 hour period.~     This information will be used with previously published information from microbiology~     laboratories to perform simulations that will provide recommendations on optimal dosing~     recommendations of these antibiotics in patients with burns.~   "
4181|NCT03002493|"~     The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme~     (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following~     intravenous (IV) administration in participants with advanced solid tumors. The secondary~     objectives of this study were to assess the safety of eribulin mesylate when co-administered~     with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.~   "
4182|NCT03002480|"~     This pilot study will investigate the use of thromboelastograph (TEG) to determine the~     primary bypassing agent for the management of bleeding in children and adults severe~     hemophilia A patients with inhibitors.~      The study will evaluate the TEG profile for each of the available bypassing agents (FEIBA~     and rFVIIa) in each participating patient, which will then determine which agent provides~     the most robust clot formation as measured by the TEG. This study will consist of screening~     visit and 2-4 pharmacokinetic studies to determine the best bypassing agent based on the~     TEG results. Patients will then be assigned that bypassing agent and dose for the treatment~     of their bleeding episodes (Prophylaxis or On-demand). Each patient will be then followed~     for a period of 6 months to monitor short-term safety of those patients whose bypassing~     agent was modified.~   "
4183|NCT03002467|"~     The Investigator postulate that the use of PESI in addition to routine clinical practice, as~     opposed to routine clinical practice based on clinical judgment alone, will help physicians~     to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk~     patients could benefit from a short hospital stay, aim of this study is to demonstrate that~     the use of PESI will lead physicians to discharge these patients earlier, thus reducing the~     duration of hospital stay of PE patients (primary outcome).~      Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating~     units represent the target population~      As the availability of DOACs may influence the duration of hospital stay, the secondary~     objectives of the present study are:~        1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on~          the method used to identify them) will reduce the incidence of hospital-associated~          complications and improve patients satisfaction and quality of life, without increasing~          the incidence of PE-related complications~        2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be~          associated with a greater proportion of patients discharged early (< 72 hours from ED~          admission) or treated entirely at home (< 24 hours from ED admission).~        3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE~          patients~        4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be~          associated with a greater proportion of patients discharged early (< 72 hours from ED~          admission) or treated entirely at home (< 24 hours from ED admission).~   "
4184|NCT03002454|"~     A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc~     -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone~     pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as~     99mTc-MDP.~   "
4235|NCT03001791|"~     The aim of the RCT is to analyse clinical and histopathological particularities for~     excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser,~     CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone~     on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding,~     the need for additional electrocoagulation or sutures and patient's postsurgical perception~     of pain, other postsurgical effects and use of analgesics.~   "
4185|NCT03002441|"~     The purpose of this randomized trial is to compare same-day cervical preparation using~     Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before~     D&E at 16.0 to 20.0 weeks.~      Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™~     plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative~     time.~      Secondary objectives: To compare treatment groups for the following: Pre-operative cervical~     dilation; need for mechanical dilation and ease of dilation if required; ability to complete~     D&E without further cervical preparation; ease of D&E; complications; pain; side effects;~     patient and provider satisfaction.~   "
4186|NCT03002428|"~     The purpose of this study is to compare the effects of two teriparatide products, PF708 and~     Forteo, in patients with osteoporosis.~   "
4187|NCT03002415|"~     Acute dehydration in the elderly is a well-known clinical condition, although situations~     that lead to chronic dehydration in the elderly may be quite frequent, but they are poorly~     studied. Metabolic changes in body water homeostasis can influence and provide chronic~     dehydration status as reduced sensitivity to thirst, antidiuretic hormone and renal~     inability to concentrate urine and the presence of chronic diseases and the use of~     polypharmacy may also predispose states of chronic dehydration. Due to these facts, a study~     to detect the existence of chronic dehydration states in a population of elderly people is~     highly justifiable. In addition, understanding whether increased water intake, improving~     chronic dehydration, may improve renal function in this population seems to be of great~     value, since it is a simple and inexpensive intervention and, if confirmed, it can be taken~     to institutions, by family members and health promoters who care for and cohabit with~     elderly individuals.~      Our main objective is to evaluate the effect of stimulated and calculated water intake (per~     kg of patient weight) on the state of hydration and renal function in a population of~     elderly individuals. It is also within the scope of this project to evaluate the presence of~     chronic dehydration in elderly patients as well as in a subgroup of diabetic patients, and~     to compare different methods of evaluation of renal function. Design: Clinical trial~     Randomized for the main objective and cross-sectional study for secondary objectives.~      The principal hypothesis is that guided water intake improve renal function in elderly~     patients.~   "
4188|NCT03002402|"~     The purpose of the proposed study are to determine if the Internet is a feasible and~     acceptable delivery method for cognitive-behavioral treatment for insomnia (CBT-I) in adults~     with asthma and comorbid insomnia; and to identify the need for asthma-related content using~     qualitative research methods (individual telephone interviews) that may be critical to the~     success of an Internet-based intervention in asthma patient populations.~   "
4189|NCT03002389|"~     Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is~     flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic~     Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of~     airways, thus, having difficulties breathing air in and out their lungs and also damaging~     the lung tissues which patients need to move oxygen from the air into blood.~      In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be~     administered to patients who are already known to have COPD. While patients are being~     treated with these two drugs (one drug at a time over a month), lung health by using usual~     testing methods (CT scan of the lung, pulmonary function test, and blood test) will be~     assessed in addition to HXe MRI.~      The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the~     state of lung health among COPD patients and also to obtain new informations on how lung~     health changes with drugs that are already approved by US FDA. This work is anticipated to~     help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD~     and if new therapies can improve lung health of patients with COPD.~   "
4190|NCT03002376|"~     This study is being conducted to compare the relationship of patient response to treatment~     to changes in tumor environment.~   "
4191|NCT03002363|"~     The purpose of the current study is to determine if pre-exposure through video modeling will~     enhance testing compliance in a population of children who are receiving a diagnostic~     evaluation for Autism.~   "
4192|NCT03002350|"~     Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is~     that some rare cells shed from primary tumor exist in the circulation of cancer patients,~     which has been proven to be related to cancer relapse and distant metastasis. The number of~     circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also~     correlated with the disease prognosis and treatment effects, which might change the decision~     of treatments. In recent years, as specific disruptive genes were discovered, such as EGFR~     in non-small cell lung cancer, KRAS in colorectal cancer, the response rate to treatment,~     disease control and survival have been much improved. However, the molecular information~     obtained from cancer tissue depends on repeated biopsies, which is very risky and invasive~     to cancer patients. By means of the advances of CTCs sampling technique with genetic~     analysis, repeated follow-up for specific gene profiles is possible. However, the protocol~     has not been well-established and mature, even the correlation between primary cancer tissue~     and CTCs remains unknown. To tackle the problems above, the aims of the project is to~     isolate high-purity CTCs by the optically induced dielectrophoresis (ODEP)-based device or~     other cell sorting techniques and transfer to next-generation sequencing (NGS) analysis for~     specific disruptive genes. In the first year of the project, the investigator will testify~     and stabilize the platform utilizing healthy donors' blood and cancer cell lines and adjust~     the detailed experiment conditions. In the following year, the investigator will enroll~     newly diagnosed metastatic cancer patients with the disruptive gene mutation(s) and follow~     up the events under gene-based therapy. Comparison of NGS information between cancer tissue~     and CTCs will be also made as one of the major endpoints. In brief, the investigator expect~     the study could establish a practical method to get genetic information, to reduce the risk~     of re-biopsy and to achieve the ultimate goal of precision medicine.~   "
4193|NCT03002337|"~     This study's aims are to examine the effects of yoga and aromatherapy on women's stress and~     immune function during pregnancy.~   "
4207|NCT03002155|"~     People with diabetes are at risk for life altering complications, including diabetic foot~     ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing~     weight on their affected limb for months. These long periods of non-weight bearing can~     result in severe physical deconditioning, putting these individuals at risk for further~     health decline. The goal of this pilot, randomized controlled trial is to evaluate the~     effects of a seated exercise program on clinically meaningful outcomes in people with~     diabetic foot ulcers. The long-term aim of this research is to improve overall health and~     quality of life in people with complications from diabetes.~   "
4281|NCT03001193|"~     The study will be designed as a double-blind, placebo-controlled, parallel-group,~     dose-finding study with one group treated with placebo and three groups treated with~     tafoxiparin in three different infusion concentration levels, respectively. The intravenous~     infusion will be initiated by a pre-defined bolus dose infusion.~   "
4194|NCT03002324|"~     This study is the second phase of a trial examining decision making about vaccines. For this~     phase of this study, the researchers will conduct a 3-arm randomized trial to compare the~     current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message,~     a new cervical cancer focused message developed by the study team, and a non-vaccine related~     control passage among parents of adolescent females. The goal of the trial will be to~     determine if the new cervical cancer framed message has an increased impact on intent to~     have daughters receive the HPV vaccine over the trial period as compared to the current CDC~     message used in the field. Additionally, the researchers will examine the impact both the~     CDC message and the new message individually have on intent to vaccinate when compared to~     the non-vaccine related control message.~      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online~     survey at baseline. Two weeks later, participants will be randomized to view one of the~     three messages: the current CDC message, the cervical cancer framed message, or a~     non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to~     vaccinate will be assessed to determine the impact of the message.~   "
4195|NCT03002311|"~     This study's purpose is to test the effects of an electronic health intervention platform~     developed by Epharmix, which features two-way SMS text messages and phone calls intended to~     improve clinical outcomes compared to the standard of care. The investigators hypothesize~     that this system can improve frequency and quality of data gathering across various~     specialties, leading to expedited provider intervention and improved health outcomes.~   "
4196|NCT03002298|"~     With the growing accessibility of computer-assisted technology, one option for~     rehabilitation programs for individuals with Duchenne muscular dystrophy (DMD) is the use of~     virtual reality environments to enhance motor practice. Thus, it is important to examine~     whether performance improvements in the virtual environment generalize to the natural~     environment. To examine this issue, we had 64 individuals, 32 of which were individuals with~     DMD and 32 were typically developing individuals. The groups practiced two coincidence~     timing tasks. In the more tangible button-press task, the individuals were required to~     'intercept' a falling virtual object at the moment it reached the interception point by~     pressing a key on the computer. In the more abstract task, they were instructed to~     'intercept' the virtual object by making a hand movement in a virtual environment using a~     webcam.~   "
4197|NCT03002285|"~     Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the~     control and execution of movements difficult. One of the possible ways to analyze motor~     control in these individuals could be through analysis of movement speed and accuracy.~     Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96~     individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age~     and sex. The software used was the Fitts' Reciprocal Aiming Task v.1.0 (Horizontal),~     performed on a computer using an external optical mouse, with progressive indices of~     difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and~     the total time/touches captured.~   "
4198|NCT03002272|"~     In this observational study, we will enroll subjects who underwent TAVR or SAVR more than 3~     years ago. Clinical and procedural data from the implant/surgery will be collected,~     alongside clinical and echocardiographic data from subsequent follow-up visits.~   "
4199|NCT03002259|"~     Background. Numerous studies have investigated high-dose corticosteroids in cardiac surgery,~     but with mixed results leading to ongoing variations in practice around the world. The~     Dexamethasone for Cardiac Surgery-II Trial (DECS-II) is a study comparing high-dose~     dexamethasone with placebo in patients undergoing cardiac surgery.~      Methods. We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic,~     multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the~     DECS-II study design (objectives, end points, target population, balanced clusters based on~     practice preference with post-randomization consent, treatments, patient follow-up and~     analysis).~      Conclusions. The DECS-II Trial will use a novel, efficient trial design to evaluate whether~     high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing~     the number of days at home after cardiac surgery.~   "
4200|NCT03002246|"~     This trial is a collaborative study between 5 sites worldwide. A total of 600 research~     subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software~     to improve on estimated fetal weight predictions over a broad range of gestational ages. The~     purpose is to compare the accuracy and precision of birth weight predictions based on this~     new technology as compared to the current 2D birth weight prediction models.~   "
4201|NCT03002233|"~     This study is a 2-part study.~      Part A is a single-dose, open-label study design to determine the PK, safety and~     tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease~     (ESRD) who require hemodialysis.~      Part B is a multiple dose, open-label study design to determine the PK, PD, safety and~     tolerability of multiple doses in subjects with ESRD who require hemodialysis with~     refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10~     μg).~   "
4202|NCT03002220|"~     Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone~     metastases and no known visceral metastatic disease. However, very few data have been~     reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently,~     results from an International Expanded Access Program have also suggested a benefit of~     radium-223 in asymptomatic patients with mCRPC. In addition, the mechanism of action of~     radium-223 should not be correlated with the presence/absence of the AR-V7 mutation,~     although this issue has not yet been evaluated.~      The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with~     mCRPC, and to establish the association between AR-V7 status and radium-223 activity.~   "
4203|NCT03002207|"~     In this prospective study the investigators seek to evaluate clinical outcomes after~     repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during~     microendoscopic discectomy for participants of lumbar disc herniation.~   "
4204|NCT03002194|"~     This study will measure the difference in skin elasticity in females only before and after~     treatment with radiofrequency and pulsed electromagnetic field therapy.~   "
4205|NCT03002181|"~     The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students~     Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain~   "
4208|NCT03002142|"~     Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with~     hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive~     to presbycusis and/or to central auditory dysfunction.~      Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis~     of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric~     tests as noisy and/or dichotic tests, are needed.~      Actually, no consensus exists to investigate hearing loss in people with Alzheimer's~     disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until~     now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease~     ignored the hearing ability of the patient. However, the major part of care management and~     investigations implies the patient's communication ability with caregivers. Hearing loss may~     be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory~     rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline~     but this management must be investigate during longitudinal studies in order to demonstrate~     their efficiency and need to be compared with a placebo.~   "
4209|NCT03002129|"~     In this study, the investigators propose to investigate a novel technique for fluid~     responsiveness prediction. It is based on the occurrence of an extra systole, which induces~     a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with~     decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.~      Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift~     but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts~     the hemodynamic effect of increasing preload, i.e. giving fluids~   "
4210|NCT03002116|"~     Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential~     diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of~     clinical examination, medical history and ankle-brachial index (ABI) measurement, which is~     considered the gold standard non-invasive modality for limb ischemia diagnosis. However,~     in diabetic patients with suspected arterial ischemia resulting in tissue loss (critical~     limb ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial~     sclerosis producing incompressible vessels, while clinical signs are subjective and not~     accurate in posing definite diagnosis of CLI.~      The investigators conducted a proof of concept study of the feasibility of microwave~     radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue~     loss.~   "
4211|NCT03002103|"~     This is a prospective, multicenter, open-label, randomized, and controlled trial to test the~     superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel~     in combination with gemcitabine.~      An independent data safety monitoring board (DSMB) will be established to decide on the~     recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the~     trial and to monitor the patients' safety and treatment efficacy data~   "
4212|NCT03002090|"~     Iron deficiency is known to negatively impact physical performance, attention, and time~     spent doing physical activity. As a result, an iron deficient person must expend more energy~     to complete the same amount of work as someone who is healthy. Another interesting~     relationship has been observed between exercise training and iron status in that women who~     participate in exercise training often have higher rates of iron deficiency than sedentary~     women. ID is commonly treated using daily iron supplementation. However, it is currently~     unknown whether participating in regular exercise somehow impacts the effectiveness of iron~     supplementation. Iron deficient women who participate in exercise programs may potentially~     benefit less from iron supplementation than those who do not. Another common treatment for~     the symptoms of iron deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li~     (BZKL). While studies have shown that BZKL impacts expression of some iron-related proteins~     and increases endurance performance in rats, no studies have examined the efficacy of BZKL~     in improving iron markers or physical performance in humans. This study will compare the~     efficacy of BZKL in improving iron status and physical performance with that of ferrous~     sulfate supplementation. The Cornell research team will achieve these objectives in~     collaboration with colleagues at Kunming Medical University (KMU) in Kunming, China. A~     double-blind, randomized, placebo controlled study will be conducted by a Cornell graduate~     student at KMU. The subjects will be healthy women, age 18-26 years, attending KMU. Blood~     samples will be collected and analyzed for measures of iron).~      Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental~     iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be~     further randomly sub-divided to receive aerobic exercise training or no training during the~     8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of~     tests as was performed at baseline. The investigators hypothesize that: 1. the women who~     train and received iron will have smaller improvements in iron status than those who do not~     train 2. The women who receive iron and train will have greater improvements in physical~     performance than those who train and do not receive iron, and 3. The women who receive BZKL~     will improve their iron status or physical performance more than those who receive placebo.~   "
4213|NCT03002077|"~     This study will evaluate the long-term safety and tolerability of rapastinel as an~     adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).~   "
4214|NCT03002064|"~     This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin~     versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic~     esophageal squamous carcinoma patients.~   "
4215|NCT03002051|"~     To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided~     transenteric drainage of PFC or of biliary tree including GB~   "
4216|NCT03002038|"~     The purpose of this study is to compare annual relapse rate, expanded disability status~     scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica~     spectrum disorder during a one year follow up through a randomized clinical trial.~   "
4217|NCT03002025|"~     The primary purpose of this study is to assess the safety, tolerability, and~     pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in~     healthy Japanese male participants.~   "
4218|NCT03002012|"~     Cryptococcal meningitis or Crypto is a life threatening fungal infection around the brain~     that requires hospitalization for treatment for 14 days and then continued therapy. Crypto~     causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected~     before one develops symptoms and becomes ill. People can be screened for infection by a~     blood test to detect cryptococcal antigen, (called CrAg), which is part of the fungus, in~     blood. The World Health Organization and over 22 countries worldwide recommend CrAg~     screening of all persons with advanced AIDS entering or re-entering into HIV care.~      However, it is not known how best to treat people with cryptococcal antigen in their blood,~     who don't otherwise yet have symptoms of infection around their brain. If no treatment is~     given, almost all people will develop infection of the brain and/or die. International~     guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole,~     to treat this early infection. However, despite this treatment approximately 1 in 4 people~     may get sick and/or die.~      Researchers have recently discovered another medicine that may work against the Cryptococcus~     fungus. This medicine is called Sertraline, and it is actually a medicine that has been used~     for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly~     used medicines worldwide.~      The purpose of this research clinical trial is to determine if standard fluconazole~     antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole~     therapy alone for treating early disseminated cryptococcal infection in persons who are~     asymptomatic and do not yet have infection of the brain (i.e. meningitis).~      This study seeks to test if Sertraline will improve survival through 6-months. Prior studies~     have shown that >90% of those who survive 6-months will survive >5 years.~   "
4220|NCT03001986|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD)~     worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its~     infection occasionally leads to severe diseases and death, with central nervous system (CNS)~     damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine.~      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished~     phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on~     the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%~     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July~     2016. The purpose of phase IVb is to evaluated the safety and efficacy of the inactive EV71~     vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei~     Province, China.~   "
4221|NCT03001973|"~     The investigators are registering LN patients at recruited hospitals and developing a LN~     database in China. Patients will be follow-up every year, and both baseline and follow-up~     information will be entered into the registration system.~   "
4222|NCT03001960|"~     TAVI is increasingly adopted as standard treatment for many subgroups of patients with~     aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance~     regarding the optimum periinterventional drug regimen.~      The study evaluates the effect of dual antiplatelet pretreatment on periinterventional~     embolic cerebral lesions and bleeding complications in patients undergoing transfemoral~     aortic valve implantation (TF-TAVI).~   "
4223|NCT03001947|"~     The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients~     at recruited hospitals and developing a IgAN database in China. Patients will be follow-up~     every one year, and both baseline and follow-up information will be entered into the~     registration system. All-cause and cardiovascular mortality and a composite renal outcome of~     doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of~     dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN~     database.~   "
4224|NCT03001934|"~     The investigators are registering all nephrotic syndrome (NS) patients regardless of the~     primary causes and developing a NS database in China. Patients will be followed-up and both~     baseline and follow-up information will be recorded in the registration system. The~     treatment response, longitudinal changes of renal function, renal survival, patient~     survival, infection events and acute kidney injury etc, will be analyzed using the NS~     database.~   "
4225|NCT03001921|"~     The investigators are registering all HD patients at recruited hospitals and developing a HD~     database in China. Patients will be follow-up every 3 months, and both baseline and~     follow-up information will be entered into the registration system. The patient survival,~     technical survival, patency rate of access, quality of life and residual renal function for~     HD patients will be compared using the HD database.~   "
4226|NCT03001908|"~     Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to~     determine the relationships between motion, pain perception, and mobility in the~     glenohumeral joint. Muscle activity, joint motion, and pain will be measured pre-post~     randomized interventions to determine the response to various physical therapy techniques.~   "
4227|NCT03001895|"~     Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is~     overexpressed manifold on prostate cancer cells and is well-characterized as an imaging~     biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is~     a nuclear medicine procedure based on the measurement of positron emission from radiolabeled~     tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to~     PSMA. The strength of functional imaging methods is in distinguishing tissues according to~     metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can~     detect prostate cancer lesions with excellent contrast and a high detection rate even when~     the level of prostate specific antigen is low.~      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT~     in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score~     at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason~     score. This is of interest because non-invasive risk stratification may be possible in the~     future.~   "
4228|NCT03001882|"~     The purpose of this study is to explore the possible links between patient characteristics~     and their cancer, with how effective the combination of nivolumab with ipilimumab is, in~     patients with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).~   "
4229|NCT03001869|"~     The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT~     and as a diagnostic and decision making tool in the management prostate cancer patients.The~     primary endpoints of the study are the incidence of adverse events (AE) in the study~     population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA~     PET/CT vs CT on a per-patient and per-lesion basis.~   "
4230|NCT03001856|"~     This study was conducted to demonstrate the equivalence of wound outcomes between the~     interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture~     (IS) methods~   "
4231|NCT03001843|"~     This study will help to determine if investigators can minimize narcotic use in laparoscopic~     gastric bypass patients while maintaining adequate pain control. This will allow~     investigators to minimize the negative side effects of narcotics which is a goal in this~     population.~   "
4232|NCT03001830|"~     The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with~     severe haemophilia A~   "
4233|NCT03001817|"~     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients~     with SHTG.~   "
4234|NCT03001804|"~     The aim of this non-interventional study is to collect primarily the percentage of patients~     who receive the full dose of dexamethasone (40 mg orally once daily on days 1, 8, 15 and 22~     of the repetitive 28-day cycles, 20 mg in> 75 year old patients) and in the registered~     indication under practice conditions.~   "
4282|NCT03001180|"~     The study will use participants tissue previously collected and stored in a tissue bank~     maintained by the Department of Hematology/Oncology as well as tissue banked in the future~     from participants undergoing prescribed surgical resection of vascular anomalies of interest~     proposed in this study. The principle investigator and study staff will also obtain blood~     from these participants.~   "
4236|NCT03001778|"~     Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g.,~     increased strength and balance, reduced frailty, fewer falls, improved brain function, lower~     mortality risk), yet many seniors have limited access to exercise options due to numerous~     barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This~     project will overcome common exercise barriers by creating an interactive web-enabled TV~     program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an~     Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF~     residents and administrators will be able to create, use, and evaluate a customizable~     exercise program tailored to the individual's preferred type of exercise, intensity, and~     duration.~   "
4237|NCT03001765|"~     Hypothesis:~      Patients that were previously discharged from the emergency department with a subsequent~     non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from~     early Reveal LINQ™ Insertable Cardiac Monitoring System placement.~      Primary Study Objectives:~      To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day~     SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™~     Insertable Cardiac Monitoring System) in patients with suspected but no previously~     documented arrhythmias that result in a clinically actionable event.~   "
4238|NCT03001752|"~     This is a three-armed randomized controlled clinical trial aiming the estimation of~     dimensional alveolar bone changes after insertion of post-extraction implants through 3~     different surgical techniques: open flap, open flap and grafting, flapless.~   "
4239|NCT03001739|"~     Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting.~     Conservative therapy of heart rate and blood pressure control in the acute phase is the~     essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal~     target for blood pressure in patients with AD so far. The American Heart Association and the~     Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower~     than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood~     pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation~     Society recommended that the blood pressure should be controlled to no less than 130mmHg.~     However, there was few large-scale, randomized, controlled studies reported on the effect of~     different blood pressure control levels on the prognosis of patients with AD. Hence, the~     intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the~     patients' outcome. Thus, in this study, the effect of intensive blood pressure control~     (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD~     patients will be compared, and to identify the therapeutic efficacy of intensive blood~     pressure control on the ABAD patients.~   "
4240|NCT03001726|"~     Investigators assessed the effectiveness of conversional gastrectomy compared with~     chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric~     cancer with a single non-curable factor.~   "
4241|NCT03001713|"~     This project aims to reduce disparities in cardiovascular disease (CVD) risk factor control~     and in rates of heart attacks and strokes among the low-income, racially / ethnically~     diverse Americans who receive primary care at safety net community health centers (CHCs). To~     achieve this important objective, the investigators will adapt a successful clinical~     decision support (CDS) system currently used in CVD care at several large, integrated health~     care systems, to meet the patient needs and workflow processes of 60 CHCs. The investigators~     will determine if use of this CDS improves CVD care, reduces disparities in CVD care and~     outcomes, and increases patient engagement in CVD treatment choices, in CHCs. Results of~     this randomized trial will help accelerate the translation of major investments in health~     informatics systems into substantial clinical benefits for large numbers of high-risk,~     low-income patients. Results will also provide a template for CVD care improvement that can~     be spread to other CHCs and extended to other clinical conditions.~   "
4242|NCT03001700|"~     To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon~     Catheter in subjects with atherosclerotic peripheral artery disease of the superficial~     femoral and popliteal arteries.~   "
4243|NCT03001687|"~     Acute inflammation induced by surgery and sepsis is complicated by the development of~     iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes~     intracellular sequestration of iron, decreasing its availability for erythropoiesis.~     Hepcidin might be a potential target to reduce transfusion requirements in surgical and~     sepsis patients. Vitamin D supplementation might constitute a novel strategy to modulate the~     hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that~     by using vitamin D supplementation in surgical and septic shock patients, the physicians~     could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a~     randomised controlled trial to determine the impact of high-dose vitamin D enteral~     supplementation on serum hepcidin levels and transfusion requirements after major abdominal~     surgery and in septic shock patients.~   "
4244|NCT03001674|"~     The primary objective of this study is to develop normative hemodynamic data (means and~     standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and~     3D-echocardiographic analyses.~   "
4256|NCT03001518|"~     The goal of this pilot study is to evaluate and describe the immunologic and overall~     outcomes of subjects who undergo routine pancreatectomy with or without irreversible~     electroporation (IRE) for pancreatic cancer. Immunologic markers in the blood will be~     measured at several time points before and after surgery to determine if surgical approach~     is associated with different immunologic responses. Secondary outcomes will include~     mortality and morbidity; operative time; blood loss and transfusion requirements; and~     oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and~     overall survival. Analysis of immune response will help the investigator determine whether~     to expand the pilot into a larger study.~   "
4257|NCT03001505|"~     This is an observational, prospective and retrospective registry of patients with pancreatic~     cancer treated in Duke University Health System, which will examine patient and treatment~     effects on cancer outcomes.~   "
4258|NCT03001492|"~     Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is~     suggested to be associated with compromized outcomes. Others found that this rise didnot~     affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would~     affect the IVF/ICSI outcomes.~   "
4245|NCT03001661|"~     Induction of labour (where labour is started artificially) is traditionally carried out with~     a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is~     a mechanical device, known as an osmotic cervical dilator, which provides an alternative to~     drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted~     into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the~     natural process of 'ripening' (or preparing) the cervix. This initial process is important~     before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions~     that, when too frequent, may cause the baby to become distressed. The project will compare~     cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a~     single pregnancy, who require induction of labour, and who are not considered high risk,~     will be invited to participate. Investigators hope to recruit 860 women from UK maternity~     units over 2 years. Participants will have an equal chance of being randomised to the drug,~     which is standard practice, or the cervical dilator. The speed in which labour commences,~     the mode of delivery and any side effects will be compared. Importantly, investigators shall~     also assess patient satisfaction and anxiety during the induction process, by asking~     participants to complete a short questionnaire about their experience before they go home~     after having their baby. If osmotic dilators are effective investigators expect NICE to~     consider them an option alongside other cervical ripening methods.~   "
4246|NCT03001648|"~     This is a single centre retrospective study in repeated implantation failure patients: < 39~     years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred~     without implantation, absence of known causes of implantation failures (uterine~     malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction,~     autoimmune disease).~      Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst~     banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally.~     Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to~     standard IVF cycles.~   "
4247|NCT03001635|"~     60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to~     2 groups. one group will receive the conventional treatment while the second group will~     receive the conventional treatment plus oxytocin infusion for 48 hours. all participants~     will undergo echo and cMRI during hospitalization.~   "
4248|NCT03001622|"~     The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The~     primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered~     over 8 weeks in these patients. In addition the trial aims to characterize the~     pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on~     the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical~     Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for~     disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA),~     Modified Sartorius Score (mSS)).~   "
4249|NCT03001609|"~     The purpose of this study is to investigate the Absorption, Metabolism, Excretion and~     Pharmacokinetics of a single dose [14C] AC0010 in male Patients With Advanced NSCLC.~   "
4250|NCT03001596|"~     The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy~     versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients~     with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).~   "
4251|NCT03001583|"~     Clinical trial comparing two health education programs for obese patients in order to~     achieve a substantial and beneficial weight loss, using mediterranean diet. Patients will be~     allocated to two groups, one will receive education in diet and lifestyle, and the other one~     the same plus cooking lessons. The intervention period is for 6 months with monthly visits~     and phone and email contacts in between. An extension observation period of two years is~     also planned with 6 months contacts in our clinic, also with phone and email contact~     available.~   "
4252|NCT03001570|"~     Nowadays the association between radiotherapy and the anti- Epidermal Growth Factor Receptor~     (anti-EGFR) monoclonal antibody Cetuximab represents a valid option in the treatment of head~     and neck locally advanced squamous neoplasm and, particularly, of oropharynx carcinoma. Up~     to date we have only indirect comparison with the standard curative treatment (i.e.~     concurrent radiochemotherapy) and the preliminary data show equivalent efficacy of both~     regimens. For this reason, concurrent Cetuximab and radiotherapy is administered in patients~     not eligible to chemoradiotherapy. The introduction of Cetuximab has been associated to new~     kind of toxicities, especially cutaneous, that have increasingly reported.~      The aim of our study is to improve the toxicity/benefit ratio in patients receiving~     concurrent radiotherapy and cetuximab for locally advanced head and neck neoplasm. Hence,~     this improvement could be achieved by modulating radiation therapy dose per fraction~     following Cetuximab pharmacokinetics.~   "
4253|NCT03001557|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of~     lemborexant (4 dose levels) or placebo taken daily for 4 weeks in approximately 125 male or~     female participants, ages 65 to 90 years, with mild or moderate Alzheimer's disease dementia~     (AD-D) who complain of disrupted sleep or multiple awakenings at night along with frequent~     periods of falling asleep during the day that impact the quality of life of the participant.~     The study is designed to determine whether at least one dose of lemborexant is superior to~     placebo based on change from baseline in actigraphy Sleep Efficiency and actigraphy Wake~     Efficiency during the last week of 4 weeks of treatment in participants with Irregular~     Sleep-Wake Rhythm Disorder and AD-D.~   "
4254|NCT03001544|"~     This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a~     single intravenous dose of TS23 in healthy adults.~   "
4255|NCT03001531|"~     Preconditioning of regional skin is known to reduce post surgery complications due to~     increased perfusion and better skin condition. The aim of this study is to prove that local~     heating through a standardized device in patients with spinal cord injury induces no~     burnings or other relevant side effects. The investigators expect an increased regional~     perfusion, temperature and redness.~   "
4280|NCT03001206|"~     The purpose of this study is to evaluate the effectiveness and usability of the Master~     Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.~      The purpose of the study is to evaluate the effectiveness and usability of using Master~     Caution 12 leads Garment for stress test.~      The purpose of the study is to reassess the adequate size of the Master Caution Garment.~   "
4259|NCT03001479|"~     Breast milk is readily accepted as the ideal source of nutrition for almost all infants,~     including premature or very low birth weight infants. However, these high-risk infants~     require the addition of fortifiers to their milk in order to achieve sufficient levels of~     calories, vitamins, and minerals for adequate growth. We are currently using a liquid human~     milk fortifier which does not provide sufficient protein intake, requiring addition of a~     liquid protein supplement. A new product has been released which provides sufficient protein~     in the liquid HMF, without the acidification seen in previous products.~      This is a prospective, randomized noninferiority study comparing the safety and efficacy of~     the new HMF with additional protein to our current standard of adding additional protein~     supplementation on top of the HMF.~   "
4260|NCT03001466|"~     Cataract is the leading cause of vision loss and blindness in the world,surgery is the only~     available option to correct the problem and the major reasons for low cataract surgical~     rates include low demand because of fear of surgery, high cost of surgery and poor visual~     results but new research raises the hope that someday, cataracts could be cured with simple~     eye drops. This is the first report for preparing urea-loaded NPs eye drops for cataract~     therapy. Enhancement of the urea efficacy is accomplished by using polymeric NPs based on~     the amphiphilic block copolymer Pluronic®F-127 (PF) which is a hydrophilic nontoxic~     copolymer widely used as a pharmaceutical excipient for its stabilizing properties and~     capability to increase the solubility.~   "
4261|NCT03001453|"~     The purpose of this study is to compare two medications currently injected intra-operatively~     to help decrease pain after surgery in patients undergoing a primary total hip replacement~     (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus~     bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to~     see if one medication works better than the other in managing post-operative pain after THR.~     The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate~     better pain management in THR patients post-operatively. Both medications are FDA-approved~     for post-operative analgesia.~   "
4262|NCT03001440|"~     Branded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved~     for the treatment of smoking cessation and depressive disorders respectively. The Risk~     Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and~     consists of a Medication Guide and a timetable for REMS assessments submission at 18 months,~     3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year~     REMS assessment to evaluate subjects' understanding of the potential serious risk of~     neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR,~     and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior~     (KAB) survey and will be conducted among approximately 125 subjects currently using or who~     have filled a prescription for a branded bupropion product for smoking cessation within the~     6 months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL~     are registered trade marks of the GSK group of companies.~   "
4263|NCT03001427|"~     This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining~     the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop~     Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control~     BP in individuals with RH. In the parent trial, participants with RH will be randomized to~     either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through~     exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA)~     control condition.~      The current protocol will collect additional assessments of neurocognition (executive~     function, processing speed, and memory), endothelial function (brachial artery flow-mediated~     dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation)~     in 120 participants at baseline, following completion of the 4-month intervention, and again~     after one year, in order to examine neurocognitive improvements and their potential~     mediators.~   "
4264|NCT03001414|"~     The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly~     dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic~     severe PAH on available PAH-targeted medical therapy.~   "
4265|NCT03001401|"~     The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical~     changes and inflammatory profile of normal eyes (matched for age, refraction and corneal~     thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may~     deliver equivalent or better clinical outcomes than SMILE, by removing less tissue and~     correcting for higher order aberrations.~   "
4266|NCT03001388|"~     To determine if transient elastography (TE), when combined with ultrasound (US) pattern~     characterization can improve the prediction of progression to a nodular pattern on US.~      To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis~     (CF) To prospectively assess whether TE data are associated with conventional laboratory~     markers of hepatic fibrosis To determine the variability of TE measurements taken at~     different sites in the same patient~   "
4267|NCT03001375|"~     This retrospective cohort study conducted on 140 patients who underwent laparoscopic~     anterior resection for upper rectal cancer in the period from May 2011 to November 2015,~     comparison will be done on splenic flexure mobilization excluding .~   "
4268|NCT03001362|"~     Patients with histologically proven adenocarcinoma of the rectum will receive pelvic~     radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5~     fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing~     chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for~     response to treatment and relapse. Salvage oncologic surgery to be offered if there is~     failure to achieve complete clinical response or in the event of a loco regional relapse.~   "
4269|NCT03001349|"~     The goal of this clinical research study is to use 68GA-DOTATOC instead of the~     standard-of-care 111-In-pentetreotide as a tracer chemical during PET/CT scans for~     diagnosing neuroendocrine tumors. A tracer is injected into participant's bloodstream to~     help the study doctor see possible tumors.~   "
4270|NCT03001336|"~     The purpose of this study is to investigate the potential association between thyroid~     function and diabetes complications in the elderly subjects with type 2 diabetes mellitus~     (T2DM).~   "
4283|NCT03001167|"~     This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth~     cohort to determine the relationships between early life antibiotic exposure, microbiome~     development, and growth.~   "
4271|NCT03001323|"~     Given the longer half life of insulin degludec compared to glargine /levemir ,investigators~     believe that insulin degludec will reduce the rate of recurrent DKA. The investigator will~     randomize participants to control and intervention group. Control group will receive~     Lantus/Levemir and intervention group will receive degludec. The investigators will call~     participants monthly and see them in the clinic every three months.The investigators will~     follow them for 1 year and evaluate if there will be a difference in rate of DKA in between~     these two groups.~   "
4272|NCT03001310|"~     Achromatopsia is a recessively inherited condition characterised by a lack of cone~     photoreceptor function resulting in impairment of colour vision and visual acuity, central~     scotoma often with eccentric fixation, disabling hypersensitivity to light (photophobia) and~     involuntary eye movements (pendular nystagmus).~      Children with CNGB3-related achromatopsia have profound sight impairment from birth or early~     infancy. The condition is currently untreatable, but there is a real possibility that a gene~     therapy could offer a significant benefit in terms of improved sight and quality of life~     (QOL), based on our own and others experience of ocular gene therapy trials )and~     pre-clinical data demonstrating improved outcome in CNGB3- related achromatopsia. Possible~     benefits of improved cone-photoreceptor function include improved visual acuity; improved~     colour perception; and relief from disabling photophobia. Although younger individuals may~     benefit most from gene supplementation therapy by virtue of their greater visual plasticity,~     it is anticipated that the intervention may offer benefit across a range of ages and the aim~     is to define this range. For this reason, participants of various ages will be included;~     children will be included only after an acceptable safety profile has been established in~     adults.~   "
4273|NCT03001297|"~     A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese~     cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884~     in healthy volunteers.~   "
4274|NCT03001284|"~     Multiple sclerosis (MS), debilitating disease involving primarily the central nervous~     system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction,~     physical invalidity, increased oxidative stress, and systemic inflammatory status, but the~     detailed mechanisms are not elucidated. The investigators aimed to assess left and right~     ventricular (LV and RV) function, left atrial (LA) function, arterial function, and~     atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV~     systolic and diastolic function and RV function were assessed by 2D- and 3D-~     echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was~     assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed~     by intima media-thickness, pulse wave velocity, and parameters of wave intensity and~     endothelial function~   "
4275|NCT03001271|"~     In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and~     demonstrates promising therapeutic potential due to it is generally opposite effects to~     Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on~     systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and~     hypertensive subjects.~   "
4276|NCT03001258|"~     Demand in near vision correction in the community exist in the Bangladesh with a thin~     presence of eye- care. This study aimed to test the skill of BRAC service-providers in~     identifying presbyopia-cases, to ensure frequent services, meeting the community need. This~     was non-inferiority equivalence randomized intervention trial, done during February-June~     2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC~     Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya-~     shebikas (SS), were assigned to three different arms consisting two sub-districts through~     permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm.~     Sensitivity and specificity was calculated to understand screening performance. Screening~     reports were matched with the gold standard by recruiting refractionists.~   "
4277|NCT03001245|"~     The aim of this cluster randomized trial is to investigate whether the brief, 1+6 session~     psychosocial intervention, Interpersonal Counseling (IPC) is more effective than standard~     professional treatment (ST) in the treatment of mild or moderate depression among 12 to~     17-year-old adolescents in services provided by school health care and counseling~     professionals (school nurses, school psychologists and school social workers). The clients~     are identified from the pool of adolescents routinely seen in school health care and~     counseling services.~      A total of 54 school nurses, social workers, and psychologists from all public secondary~     schools in the standard education system of City of Espoo, Finland will be trained in IPC in~     a three-day workshop in two waves. Each school (plus the one primary care level health care~     unit for adolescents in Espoo) is represented by 1-3 trial IPC counselors. In the first wave~     the schools are cluster randomized to provide either A) 1+6 sessions of IPC, or B) 1+6~     sessions of standard treatment (ST), which consists of psychosocial work as guided by the~     workers' own standard professional principles and methods. The workers randomized to deliver~     IPC get the IPC training immediately. In the second wave those who delivered ST in the first~     wave will be trained in IPC. The data for this trial will be collected from the first wave.~     The data collection period is one school year plus follow-up of clients after 3 and 6~     months.~      The clients are adolescents who have either self-referred themselves, are referred by other~     school personnel, or by parents to the services offered in the school due to emotional~     symptoms in the school year 2016 -2017 in the participating schools. They are screened with~     the BDI at the initial visit to identify depressive symptoms. A diagnostic interview will be~     administered to those exceeding a clinical cutoff. Main inclusion criterion is DSM-5~     depressive disorder of either mild or moderate severity. Those with current harmful alcohol~     use, acute suicidal ideation or behavior, severe depression or anxiety disorder, psychotic~     symptoms or very low global level of functioning are excluded and offered other treatment.~      The clients will complete self-report questionnaires (BDI) as outcome measures. Their level~     of depression symptoms will also be assessed with ADRS scale and their level of global~     psychosocial functioning with the CGAS by the project IPC counselors / ST providers.~     Moreover, the clients will complete the Young Person's Clinical Outcomes for Routine~     Evaluation (YP-CORE) as a measure of global symptomatology after each session. A follow-up~     interview at 3 months and 6 months after treatment termination will be arranged. The~     K-SADS-PL will be used for diagnostic evaluation, the ADRS and the C-GAS to assess level of~     depressive symptoms and global functioning, and the adolescent completes both the BDI and~     YP-CORE as self-reports of symptomatology.~   "
4278|NCT03001232|"~     The purpose of this study is to determine whether movement-oriented dementia care has a~     positive effect on quality of life and independence in activities of daily living (ADL) in~     nursing-home residents with dementia.~      It was hypothesized that movement-oriented dementia care has a positive effect on quality of~     life and independence in ADL, as well as on mood, behavior, cognition and physical~     functioning, in comparison to regular care.~   "
4279|NCT03001219|"~     This is a Phase 2 double-blind, placebo-controlled, randomized, parallel group, multicenter~     study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants~     with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha~     therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and~     safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of~     continuing to the extension period of the study.~   "
5810|NCT02981121|"~     The investigators will study prevention effect of Life style modification on diabetes~     mellitus comparing with conventional management and Metformin administration.~   "
4284|NCT03001154|"~     Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but~     because of the high financial costs and technical complexity of the past generation of VR~     hardware, there has been no large-scale implementation of this promising treatment. The~     present study will investigate whether off-the-shelf, commercial VR hardware and software~     can be used as stimuli material to conduct in-session exposure therapy for speech anxiety.~     The study will recruit n=25+25 participants from the general public suffering from~     substantial speech anxiety, who will be randomized to either a waiting-list, or one-session~     VRET with a therapist, followed by four weeks of a progressive maintenance program~     encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered~     VRET treatment program.~   "
4285|NCT03001141|"~     This is a prospective, multicenter, non-randomized registry/observational study. The study~     will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac~     Resynchronization Therapy (CRT) MP device implant from up to 10 centers.~   "
4286|NCT03001128|"~     The purpose of this study is to collect information about what happens when people pause, or~     temporarily stop taking, ART, and to collect blood samples from these people at frequent~     intervals. We will also study the safety of pausing ART under close observation.~   "
4287|NCT03001115|"~     The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis~     Suppurativa (HS) participants in normal medical practice.~   "
4288|NCT03001102|"~     Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms~     which purpose is verify the effects of nursing intervention preoperative bathing with 4%~     chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the~     prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.~   "
4289|NCT03001089|"~     Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway~     (renin-angiotensin-aldosterone system acting on the renal tubule). However, the neonatal~     period in humans is characterized by a reduced ability of the kidney to ensure normal~     functions of urine concentration and maintenance of sodium and water balance. This renal~     functional immaturity, is associated in the very premature infants (VPT) (born <32 weeks of~     amenorrhea (SA)) to an immaturity of the adrenal responsible for a default of aldosterone~     biosynthesis . This relative aldosterone deficiency induces difficulties for VPT to adapt to~     extra-uterine life when maintaining a positive sodium balance is essential for postnatal~     growth. The improvement of perinatal care (antenatal corticosteroids maturation, ventilation~     techniques and use of surfactant) have increased the survival of these children .~     Nevertheless, extreme prematurity (less than 32 weeks), which concerns nearly 2% of live~     births in France, remains associated with neurodevelopmental sequelae in nearly 40% of~     children at 5 years .~      Secondary hydroelectrolytic disorders with transient mineralocorticoid adrenal insufficiency~     is probably one of the factors responsible of these neurological deleterious outcomes as~     well as the occurrence of other complications (bronchopulmonary dysplasia, enterocolitis~     necrotizing) of extreme prematurity. Indeed, aside from the administration of antenatal~     steroids to induce maturation, the prevention of postnatal dehydration reduces the risk of~     intracranial hemorrhage in that population. However, high fluid intake are associated with~     an increased incidence of patent ductus arteriosus, of bronchopulmonary dysplasia and~     necrotizing enterocolitis. This necessitates the evaluation of preventive measures to avoid~     such fluid and electrolyte imbalances by a pharmacological approach based on~     mineralocorticoid administration in very premature infants, due to the relative aldosterone~     deficiency identified in this population.~   "
4290|NCT03001076|"~     The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe~     therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.~   "
4291|NCT03001063|"~     This stepped wedge, randomized controlled trial will test the effectiveness of a Supported~     Self-Management intervention for depression among adults in Vietnam. The intervention will~     be delivered at the community level in 8 Vietnamese provinces by primary care providers and~     social workers. The intervention group will receive the Supported Self-Management~     intervention, while the control group will receive enhanced treatment as usual. The primary~     outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World~     Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE~     (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional~     ability and alcohol misuse.~   "
4292|NCT03001050|"~     The overall goal of doing this study is to improve long term patient function and outcomes~     in the healing rates of Rotator Cuffs. The investigators would also like to see if this~     method can be more cost effective and time efficient for Rotator Cuff evaluation during~     arthroscopy.~   "
4293|NCT03001037|"~     This study will compare patients with low back pain (LBP) to age and gender matched controls~     to determine if there are differences between the two groups related to: range of movement,~     secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or~     stress), movement patterns and demographic characteristics. The first phase will include a~     baseline and 3 month follow-up assessment of the LBP patients and controls, including~     demographic characteristics, outcome measures, and a physical assessment. The second phase~     is an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12~     months.~   "
4294|NCT03001024|"~     Responsible Beverage Service Training (RBS) has been shown to be effective and recent~     research by this research team has shown that online RBS training (WayToServe®) was more~     effective, particularly over time, than usual and customary (UC) RBS training by live~     trainers. However, one growing segment of alcohol servers and sellers has been neglected in~     RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly~     Spanish-speaking premises. This project will develop and test the first online RBS training~     for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and~     linguistically appropriate and will fill a gap in evidence-based alcohol prevention~     interventions for this underserved population.~   "
4295|NCT03001011|"~     Primary Objective:~      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in~     hyperphosphatemia in patients with chronic kidney disease not on dialysis.~      Secondary Objectives:~      To document the efficacy of Renvela tablets in the reduction of serum lipids (total~     cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of~     Renvela tablets in the reduction of calcium-phosphorus product.~      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone~     (iPTH).~      To document the efficacy of Renvela tablets in proportion of patients reaching the target~     serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).~      To evaluate safety of Renvela tablets.~   "
4326|NCT03000608|"~     This trial will be a double-blind, single-center, randomized, placebo controlled study to~     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for~     up to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of~     mild-to-moderate plaque psoriasis.~   "
4296|NCT03000998|"~     The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended~     levels, particularly for adolescent boys and especially among minority families. Proposed~     here is a mobile web application (mobile web app) for personal computers, smart phones,~     and tablet computers that will accurately inform parents and adolescent boys about the HPV~     vaccination and address unique concerns about its safety and effectiveness for boys. The~     BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a~     randomized efficacy trial with parents and adolescent boys aged 11-13 years who obtain care~     in pediatric clinics in the University of New Mexico Health Sciences Center's Envision~     network.~   "
4297|NCT03000985|"~     The involvement of family members is crucial and improves the prognosis of psychiatric~     patients and reinforces therapeutic adherence and reduces the frequency of relapses. For~     schizophrenia, the scientific literature clearly shows that it's in the interest of the~     patient to offer to his family a psychoeducational program.~      Therapeutic education programs are now part of the recommendations of good clinical practice~     and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the~     hospital and relating to patients, health and territories.~   "
4298|NCT03000972|"~     This study evaluates the potential negative effect of cement augmentation in the femoral~     head on viability of the head. Half of the participants will have the standard~     intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will~     get the standard nail plus cement augmentation.~   "
4299|NCT03000959|"~     This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing~     the functional outcome between those patient admitted in the general neurology wards and~     stroke units using modified Rankin Scale~   "
4300|NCT03000946|"~     The purpose of this study is to determine whether somatostatin is more effective that~     octreotide in the prevention of post-pancreatectomy pancreatic fistula~   "
4301|NCT03000933|"~     Australia was one of the countries to implement a universal school-based male vaccination~     program - in 2013. This research project will examine the prevalence of HPV among young men~     who have sex with men (MSM) who have been offered school-based HPV vaccination.~   "
4302|NCT03000920|"~     Each year in France, breast cancer affects about 48,000 women and is the first cause of~     cancer death in women with 11,900 deaths estimated.~      Since 2004, there is a national organized breast cancer screening (OBCS) programme for~     asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer~     screening department sends a personalized invitation mail to eligible women to perform a~     mammogram and a breast clinical examination. One to two reminder mails are sent to women who~     have not done the screening after an initial invitation. Despite this programme, almost 47%~     of women in France do not participate to organized breast cancer screening.~      The Short Message Service (SMS) is an innovative communication tool in the field of health,~     immediate, reliable delivery, low cost and ecological. The use of SMS could be an~     innovative, low-cost, personalized and ecological way to support the OBCS invitation~     strategy.~      The overall objective of this study is to preserve or even better increase participation in~     organized breast cancer screening while decreasing the associated costs by including SMS in~     our screening invitation procedure.~      Two SMS interventions will be tested which will correspond to different phases of the OBCS~     invitation procedure. This sequence of interventions leads us to perform three interlinked~     trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few~     days before the initial mail invitation), then two non-inferiority trials for the second~     phase ( two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place~     of the first postal reminder).~   "
4303|NCT03000907|"~     Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the~     elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a~     fatty infiltration of the muscle and an increased cardiovascular risk and, in addition,~     obese people usually perform less physical activity. All this favors the loss of mass and~     muscular function (sarcopenia), a key component of the fragility and the functional~     deterioration.~      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the~     prevention of frailty in obese elderly people, as well as to know the main mechanisms~     involved in the frailty process.~      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel~     intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of~     age, obese (BMI ≥30), without criteria of fragility and living in the community. Study~     intervention: multimodal and personalized intervention with the support of a personal~     trainer that has two main axes of action: a) diet: assessment of nutritional status and~     nutritional requirements and establishment of personalized nutritional plan with monthly~     dietetic controls and b) physical exercise: a multi-component physical exercise program that~     will include aerobic exercise and strengthening, balance and flexibility exercises as well~     as a weekly group session of health education, during six months. Main outcome measures (to~     be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and~     Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older~     People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle~     grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by~     bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss,~     b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and~     insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk~     according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2~     Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor~     Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and~     testosterone).~   "
4304|NCT03000894|"~     This study aims to investigate the effectiveness of transdiagnostic nurse-administered~     4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care,~     compared to standard care alone, for improving sleep and daytime function, enhancing~     recovery, preventing relapses, and reducing medication burden in patients with the first~     episode of mood disorders.~   "
4305|NCT03000881|"~     The study investigates the impact real output has on peristomal skin covered by two~     different adhesives~   "
4306|NCT03000868|"~     This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic~     mucosal resection with hot endoscopic mucosal resection. Half of the participants will~     receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic~     mucosal resection.~   "
4307|NCT03000855|"~     EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage~     in unresectable malignant distal CBD strictures when endoscopic retrograde~     cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with~     covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD~     strictures is uncertain.~      The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in~     unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a~     higher 1-year stent patency rate.~   "
4308|NCT03000842|"~     The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic~     regulatory way. In order to minimize the harm of a surgery chip implantation, actually it~     was developing a non-invasive device that is able to stimulate the auricular branch of vagal~     nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct~     stimulation of the vagal nerve. However, there are still no strong evidences about it~     actions regarding the autonomic modulation. The aim of this study is to evaluate effects of~     tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive~     subjects, at rest and after orthostatic position~   "
4309|NCT03000829|"~     This multicenter randomized trial will employ in-situ cardiac arrest simulations (mock~     codes) to test whether using telemedicine technology to add an intensive care physician as~     the copilot for cardiac arrest resuscitation teams influences chest compression quality,~     resuscitation protocol adherence, team function, and provider experience.~   "
4310|NCT03000816|"~     The aim of this phase II trial is to assess the non-progress survival，local control，overall~     survival，safety and tolerability of SBRT to treat patients with oligometastases in~     esophageal squamous cell carcinoma.~   "
4311|NCT03000803|"~     The purpose of this study is to examine how the timing of eating changes how the body makes~     and uses energy (metabolism). This study will also examine how fat cells respond to insulin~     (a hormone that controls blood sugar levels).~   "
4312|NCT03000790|"~     To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc~     Displacement With Reduction~   "
4313|NCT03000777|"~     The purpose of this study is to evaluate the effects of oral melatonin plus zinc~     supplementation in relieving self-reported fatigue in CFS/ME~   "
4314|NCT03000764|"~     The purpose of this study is to seeking a molecular signature of pathological radiation~     induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two~     groups of patients distinguished by their individual radiosensitivity. The signature will~     integrate recent insights in terms of alternative splicing of mRNAs and level of expression~     of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In~     each group each expression patterns of candidate HSP proteins potentially predictive of~     pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on~     cell culture will be characterized.~   "
4315|NCT03000751|"~     To explore variation in doses used for diagnostic CT by pooling radiation dose data across~     diverse healthcare delivery systems.~      To identify the barriers and facilitators to implementing successful dose optimization~     strategies and standardizing practice.~   "
4316|NCT03000738|"~     The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio~     could help predict the prognosis of DLBCL and PTCL.~   "
4317|NCT03000725|"~     The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and~     depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a~     home-based intervention that teaches cognitive and mindfulness skills to people with~     epilepsy by phone to reduce their depression and improve quality of life (QOL); it was~     developed at Emory University with CDC funding. The purpose of this study is to adapt~     Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using~     Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that~     teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their~     depression and improve quality of life (QOL); it was developed at Emory University with CDC~     funding.~   "
4318|NCT03000712|"~     The purpose of this study is to evaluate the efficacy and safety of intra-articular~     injection of autologous adipose tissue derived mesenchymal stem cells compared after high~     tibial osteotomy to negative control in the osteoarthritis patients~   "
4319|NCT03000699|"~     The purpose of this study is to determine whether computer bias modification for~     interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance~     use disorders.~   "
4320|NCT03000686|"~     This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide,~     modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers.~     The study will be single-center, randomized, placebo-controlled and double blind (sponsor~     open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881~     or placebo (saline) in a crossover design. The primary objective of the study is to evaluate~     the effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers~     during exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a~     maximum of 56 days.~   "
4321|NCT03000673|"~     To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease~     treated with hemodialysis~   "
4322|NCT03000660|"~     This is a study to determine the safety, tolerability and maximum tolerated dose of~     Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL)~     amyloidosis patients.~   "
4323|NCT03000647|"~     The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic~     floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple~     Sclerosis~   "
4324|NCT03000634|"~     This study will compare the effectiveness and safety of maintenance therapy with continuous~     bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that~     alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.~   "
4325|NCT03000621|"~     The objectives are to:~        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the~          plasma of patients with and without liver injuries~        2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects~          and under stress~        3. investigate the dysregulation of circulating miRNA panel and their prognostic and~          predictive values in clinical outcomes in identifying patients at high risk for~          mortality and acute liver failure.~      This trial involves peripheral blood sampling from subjects at their earliest presentation~     and remaining stays in the hospitalization in the emergency department. The investigators~     will develop panels of miRNAs that are specific indicator of early onset of major organ~     failures, and correlate clinical outcomes with these miRNAs.~   "
4908|NCT02992990|"~     To assess whether the addition of a bladder tumor biopsy improves the level of agreement~     between the pretreatment endoscopic impression and the final postoperative pathology~     determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.~   "
4330|NCT03000556|"~     Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about~     10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in~     Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and~     effective, corneal epithelial damage can be recovered within 48 hours. However, about 25%~     TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the~     treatment would be more difficult and even cause blindness. Therefore, it is of great~     practical significance to prevent the recurrence of TCA. However, there is no effective~     methods to prevent recurrence of TCA.~      0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and~     promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3%~     sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to~     test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a~     prospective, single center, randomized, controlled pilot study. In this study, 60 patients~     with TCA were randomly divided into control group and sodium hyaluronate treatment group and~     observed one year.~   "
4331|NCT03000543|"~     Background:~        1. Burden: Recently Bangladesh has introduced mandatory vitamin A (VA) fortification of~          refined edible oil while high dose VA supplementations for infants and children are~          still in place as part of national program. Thus preschool children are plausible at~          risk of hypervitaminosis A.~        2. Knowledge gap: Serum VA concentration is not an authenticate indicator of VA status,~          while existing deuterium- VA isotope dilution methods to determine whole body VA status~          require 3 weeks and not applicable for infants and children.~        3. Relevance: Our research group has recently developed a new simplified equation to~          measure VA pool size in 4-5 days, highly correlated with compartmental model-predicted~          value and estimate VA pool size in adults with high precision. However, it is not clear~          whether this new simplified equation also works in infants and children. In this~          proposed study, we validate the method in healthy infants and infants with inflammatory~          condition as well as in children with adequate and high dietary VA intake.~      Hypothesis: (1) Whole-body VA status in infant and children can be estimated without~     accounting for fractional catabolic rate in the context of inflammatory condition or higher~     dietary VA intake (2) Fortification of commonly consumed food item with VA along with~     periodic high dose VA supplementation would increase the risk of hypervitaminosis A among~     preschool children in Bangladesh~      Methods: Our study comprises two studies. Study 01 will be undertaken in infants while~     Study 02 for preschool children. At first we need to undertake one feasibility study to~     verify whether the oral dose of 400 μg 13C10 or 13C3- retinyl acetate (isotopic VA) that we~     propose to use in this study would work in infants as we observed in adults, secondly,~     whether PENTA valent vaccines induce inflammation in infants (plasma CRP as maker) that~     closely mimics natural infection. We need such infants with inflammatory condition in Study~     01 to answer the question of whether the isotope dilution technique will still work in~     children who undergo inflammation. Information of the reliability of the retinol isotope~     dilution technique in infectious conditions is important as national dietary assessment~     surveys often observe children with chronic or latent infection. To minimize the taking of~     multiple blood samples from each infant/child in both studies, a super kid study design~     will be adopted that ensure no more than 2 venous blood samples from each infant/child, even~     though multiple time points (at least 5 subjects / time-point) over a 28-day study period~     will be available for mathematical modelling. In Study 01 a total of 115 infants (9-11 mo)~     will receive an oral dose of 13C10- retinyl acetate (400 μg) dissolved in 0.5 mL of~     sunflower oil and then blood samples will be taken from 6h to 16th day at 9 different~     time-points. On day 16, a single dose PENTA vaccine will be provided to the randomly~     selected 50% of infants. On day 17, another type of stable isotopic VA e.g. 13C3- retinyl~     acetate (400 μg) will be orally supplemented to all infants. Blood sample will be collected~     from day 16 to day 28 at 11 different time-points for each of the vaccine and non-vaccine~     groups. In Study 02 50 children (3-5y) in each of the adequate dietary VA intake group~     and higher dietary VA intake group will be enrolled to receive an oral dose of 13C10-~     retinyl acetate (400 μg). Blood sample will be collected from 6h to day 28 at 11 time-points~     for each of the two groups. Specific activity of 13C10-VA and 13C3-VA from the blood samples~     will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS). Plasma~     biomarkers of VA toxicity e.g. bone metabolism, liver fibrogenesis and VA metabolites will~     be measured in the children of Study 02.~      Outcome measures/variables: (1) The early time point equation for assessing VA pool size in~     a group of infants with or without inflammation and in a group of children with adequate or~     with high dietary VA intake. (2) The association between biomarkers of VA toxicity and~     estimated liver vitamin A concentration in preschool children at risk of hypervitaminosis A.~   "
4332|NCT03000530|"~     This is a two-part (open-label followed by double-blind) study evaluating the safety,~     tolerability, pharmacokinetics, and efficacy of SAGE-217 in up to 62 subjects diagnosed with~     moderate to severe Major Depressive Disorder.~   "
4333|NCT03000517|"~     The emergence and spread of multi-drug resistant and extensively-drug resistant strains of~     Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and~     elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various~     factors contributing to the development of drug resistance, low drug exposure is well~     recognized. To overcome this, either new drugs have to be developed or the dose of currently~     used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and~     aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired~     drug resistance to these drugs could complicate and narrow down the available options, and~     further exacerbate to pre-XDR and XDR-TB.~      Objective:~      The main objective of this prospective clinical study is to understand the pharmacokinetics~     of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body~     weight and correlate drug exposure, with treatment outcomes.~      Study design:~      A prospective pharmacokinetic study~      Study population: 20 MDR-TB patients~      Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on~     the body weight, under MDR-TB treatment regimen of Nepal.~      Main study parameters/end points:~      The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points~     of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for~     efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated~     in plasma and in oral fluid~   "
4334|NCT03000504|"~     This study is designed to assess whether a new type of chest drain reduces the number of~     drains that fall out of or are accidentally removed from the chest cavity (usually requiring~     another drain to be inserted), without causing any increase in discomfort or other~     side-effects.~   "
4335|NCT03000491|"~     This study forms an initial phase of work aimed at developing a learning health system~     (LHS), whereby data relating to asthma is extracted from patient electronic health records~     (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared~     with general practices to highlight any improvements that can be made so that they can~     better support people with asthma.~      If successful, the investigators hope to progress to the main quality improvement phase~     involving an increased number of practices and then incrementally build this up to cover the~     whole of Scotland.~   "
4336|NCT03000478|"~     This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure~     Therapy in adult patients with combat related PTSD.~   "
4337|NCT03000465|"~     Optimizing all factors that increase the intra-abdominal volume and performing an~     individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure~     while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared~     to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15~     mmHg).~   "
4338|NCT03000452|"~     This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the~     combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts;~     Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will~     receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2~     weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior~     therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of~     the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day~     2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.~   "
4339|NCT03000439|"~     A randomized withdrawal study in which responders to open-label treatment with tofacitinib~     will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the~     double-blind phase time to sJIA flare will be evaluated as primary endpoint and subjects~     will be discontinued once they experience sJIA flare. Once 31 flares are reported the study~     will be completed.~   "
4340|NCT03000426|"~     The aim of this study is to compare the influence of two different energy densities for~     photobiomodulation on recovery of palatal donor area after free gingival graft technique.~   "
4341|NCT03000413|"~     Despite few scientific evidence that could support the use of ketamine in adult patients~     undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely~     employed in this setting. The aim of this study is therefore assess more definitively the~     real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and~     need for MV in order to establish or refute the use of this drug as standard therapy in~     these cases.~   "
4342|NCT03000400|"~     The purpose of this study is to determine the effectiveness of a multi-professional~     theoretically based family centered intervention, The Traumatic Brain Injury Family System~     Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics~     and functioning. The intervention will be provided in collaboration with the municipal~     rehabilitation service. The intervention group will be compared with a control group~     receiving treatment as usual, defined as an individually tailored multidisciplinary~     approach, and the family members will attend one ongoing psycho-educational group session of~     2.5 hour provided by Oslo University Hospital (OUH).~   "
4343|NCT03000387|"~     Medications for smoking cessation are currently only effective in helping a minority of~     smokers quit. Drug development is slow and expensive, so there is much interest in~     optimizing the effectiveness of existing treatments and medications. Current standard doses~     of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases~     provide less nicotine compared to when a smoker is smoking their usual number of cigarettes.~     The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will~     improve quitting success in those who do not respond to a standard dose of NRT (21mg).~   "
4344|NCT03000374|"~     Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance~     imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for~     preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of~     panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response~     (pCR)~   "
4345|NCT03000361|"~     The aim of this study is to assess the feasibility and the safety of the Novel Motorized~     Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with~     the primary aim to achieve a cecal intubation rate of at least 90 % according to quality~     guidelines recommendations. All other clinically relevant quality parameters of standard~     colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study~     represents the first clinical evaluation of using a motorized spiral assisted endoscope for~     examination of the colon with potential advantages for patients in terms of effectiveness~     and convenience of colonoscopy.~   "
4346|NCT03000348|"~     This study investigates the use of cysteamine in the treatment of adults with Cystic~     Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six~     different potential dosing regimens, including one that is placebo.~   "
4347|NCT03000335|"~     Previous findings have shown that a biomarker comprised of the three microRNAs (miRs)~     miR-451, miR-151-5p and miR-1290 can independently predict precursor B-cell acute~     lymphoblastic leukemia (B- ALL) patients' risk for relapse when measured in cells from a~     bone marrow (BM) aspiration taken at diagnosis (Avigad et al., 2016: Genes, Chromosomes &~     Cancer 55:328-339). Curewize Health recognizes that the development of a minimally invasive~     blood test for frequent long-term monitoring can greatly benefit pediatric precursor B-ALL~     patients. Therefore, the current study will investigate the monitoring ability of miR-451,~     miR-151-5p and miR-1290 measured in blood samples. The study will be performed in two~     stages:~      Stage 1-Cross-Sectional Study: Blood samples will be collected from relapsed pediatric B-ALL~     patients and B-ALL patients in remission. Blood will be collected from each patient in three~     tubes, for serum, plasma and whole blood analysis, in order to interpret the best blood~     source for measuring miR-451, miR-151-5p and miR-1290. The level of the miRs in blood will~     be compared between relapsed B-ALL patients to B-ALL patients in remission. If the Stage 1~     Cross-Sectional study is successful, the investigators will continue the clinical trials to~     the Stage 2 Prospective Monitoring study.~      Stage 2-Prospective Monitoring Study: Blood will be collected from patients at diagnosis and~     at routine clinical follow-up. Patients can be up to five years from diagnosis. The source~     of blood found to be most optimal for measuring the miR levels is Stage 1 will be collected.~     The final design of the Stage 2 study will be decided after completion of the Stage 1 study.~   "
4348|NCT03000322|"~     This study is intended to determine the efficacy of the Cooling Vest in reducing the~     frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy~     treatment for prostate cancer.~   "
4349|NCT03000309|"~     Sixteen week open label study of apremilast in combination with topical steroids with a four~     week safety follow up visit.~   "
4350|NCT03000296|"~     This study evaluates the safety and clinical benefits of a therapeutics approach of~     conditioning regimen Cyclophosphamide (Cy) + Thymoglobulin r (ATG) + Granulocyte~     Colony-Stimulating Factor (G-CSF) followed by autologous Hematopoietic Stem Cell~     Transplantaion (HSCT) rescue in therapy refractory Crohn's disease. It will be counted~     adverse events, clinical and endoscopic condition at various short and long-term time~     points.~   "
4351|NCT03000283|"~     The goal of this study is to preliminarily determine/estimate feasibility and whether~     frequent and early conivaptan use, at a dose currently determined to be safe (i.e.,~     40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral~     hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether~     conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This~     study is also an essential first step in understanding the role of conivaptan in CE~     management.~      Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and~     well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage~     and pressure.~   "
4352|NCT03000270|"~     Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in~     patients with ST-elevation myocardial infarction (STEMI) is safe and feasible~   "
4353|NCT03000257|"~     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2~     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)~     profile of ABBV-181. The study will consist of 2 parts: ABBV-181 dose escalation and~     ABBV-181 dose expansion.~   "
4374|NCT02999984|"~     This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical~     study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101~     (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS LV~     encoding for the human ADA gene) administered to ADA-SCID subjects between the ages of 30~     days and 17 years of age, who are not eligible for an HLA-matched sibling/family donor and~     meeting the inclusion/exclusion criteria. The OTL-101 product will be infused after a~     minimal interval of at least 24 hours following the completion of reduced intensity~     conditioning. For subjects who have successfully received the OTL-101 product, PEG-ADA ERT~     will be discontinued at Day+30 (+/-3) after the transplant. After their discharge from~     hospital, the subjects will be seen at regular intervals to review their history, perform~     examinations and draw blood samples to assess immunity and safety.~   "
4375|NCT02999971|"~     The objective of this study is to investigate the relative effectiveness of CCT on water~     versus on land in stroke patients. Additionally, the study will to determine if there are~     differences in the results obtained, between two CCT programs in the following parameters:~     gait, balance and dexterity~   "
4354|NCT03000244|"~     Background:~      People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow~     or an immune system that is damaged. They get stem cells from a donor who is a relative.~     Researchers want to study stem cell donors and recipients to learn about the long-term~     effects of HCT. They want to learn how the stem cells change and how to improve their~     ability to fight cancer.~      Objectives:~      To provide long-term follow-up care for people who underwent or will undergo HCT. To collect~     data, blood, and tissue samples to learn about late complications after HCT.~      Eligibility:~      Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or~     more from the date of HCT. The stem cell donors for these recipients are also needed.~      Design:~      Recipients will have 1 visit each year. They will have a physical exam. They will answer~     questions about their medical history and health. They will receive screening and~     surveillance testing. They will complete brief questionnaires.~      Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue~     in their cheek or skin or bone marrow biopsy).~      Recipients will give their current address and phone number, and the same data for one or~     two other people, who can get in contact with them.~      After the first visit at the clinic, some recipients may see a doctor close to home to get~     the necessary information and send it to NIH.~      Donors will come to the clinic for 1 visit. They will answer questions about their medical~     history. Blood samples will be taken.~   "
4355|NCT03000231|"~     The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night~     time blood pressure between healthy control subjects and patients with adrenal~     insufficiency. No intervention will be administered and the study is observational only.~   "
4356|NCT03000218|"~     A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who~     are overweight and have liver problems after ursodeoxycholic acid multiple administration~   "
4357|NCT03000205|"~     Using hypertonic dextrose water for chronic supraspinatus tendonitis and using ultrasound as~     assessment tool to evaluate the effect of intervention.~   "
4358|NCT03000192|"~     The purpose of this study is to invite all people diagnosed with cancer who meet the~     eligibility criteria to complete questionnaires before their treatment begins and at regular~     intervals over time to assess the impact of cancer and its treatment on people's lives in~     the short, medium and long term. We will explore a range of factors to determine their role~     in both recovery of health and well-being and self-management. Although it is known that~     people who have had cancer are likely to experience a number of physical and psychological~     problems as a result of the disease and treatment, it is not known what the 'typical' course~     of recovery of health and well-being looks like, how long it takes and how this can be~     influenced. We will determine pathways to recovery of health and well-being following cancer~     diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and~     gynaecological cancers) and identify what factors influence this. This includes assessing~     the relative importance of the person's illness, personal attributes, perceived burden of~     treatment, role of the environment they live in, including health / social care and personal~     networks of support, and their ability and capacity to self-manage. We will identify who is~     most at risk of problems and what environmental supports and resources people are able to~     mobilise to support their self-management. We will also explore who has the confidence and~     ability to manage during and beyond treatment and what factors influence this and whether~     this leads to earlier problem resolution and restoration of health and well-being. This~     knowledge will be used to develop and test future supportive interventions to enhance the~     rapid recovery of health and well-being - our long term aim being to design ways of helping~     people with cancer in areas we identify as problematic for them.~   "
4359|NCT03000179|"~     This is a single-agent, open label, one-arm phase 2 pilot study of avelumab in patients with~     advanced or metastatic adenocarcinoma of the small intestine.~   "
4360|NCT03000166|"~     The purpose of the study is to determine the impact of a physical activity intervention on~     the self-management of fatigue in young adults receiving chemotherapy. Half of the~     participants will receive an intervention which includes education and resources to set~     physical activity goals and monitor progress toward goals.~   "
4361|NCT03000153|"~     Recent evidence suggests that focusing on positive goals rather than problems to avoid, may~     be associated with better psychological health and attainment of goals (Elliot & Church,~     2002; Elliot & Friedman, 2007). In addition, the advantages of using personalised measures~     have been highlighted in a number of studies (e.g., Ashworth et al., 2005). The Goals Form~     is a new measure that comprises both elements. It invites clients, in collaboration with~     their therapist, to identify up to seven goals for therapy typically at a first assessment~     session and then to rate them on a 1-7 Likert scale, with 1 being not at all achieved and 7~     being completely achieved. This research is important for clinical practice as it provides~     the foundations to identify what might be a helpful factor in counselling and psychotherapy.~      The aim of the study is to test whether the use of the Goals Form leads to better clinical~     outcomes in counselling and psychotherapy. Participants in this study are counsellors and~     service users at Tower Hamlets Mind. The design of this study is a trial, which looks at~     comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form'~     when participants are randomly assigned to one of the two conditions. Interventions in this~     study involve using the Goals Form at the start of every session and taking part in a 30~     minute interview once therapy has ended to give feedback about using the form in therapy .~     In addition to assessing outcome, the study also serves to compare satisfaction scores~     across the two conditions. It is a pilot to determine the feasibility of such trial~     including recruitment rates over a period of a year, adherence of counsellors and clients to~     the protocol, and the ethical issues raised.~   "
4362|NCT03000140|"~     Despite exercise training decrease blood pressure in 'average' terms, there is a wide~     interindividual variability after exercise training, being yet unknown what mode of exercise~     (e.g. endurance, strength, concurrent, or high intensity interval training) produce~     more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a~     non-change/worsened response after training in some outcome).~   "
4363|NCT03000127|"~     Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are~     limited. Several studies have shown that a large proportion of men with MS have low~     testosterone levels. We propose a two-site clinical trial using topical testosterone gel as~     a treatment for MS-related fatigue in men with progressive MS who have low or low-normal~     testosterone levels.~   "
4401|NCT02999633|"~     Primary Objective:~      To evaluate the efficacy of isatuximab.~      Secondary Objectives:~        -  To evaluate the safety profile of isatuximab.~        -  To evaluate the duration of response (DOR).~        -  To evaluate progression free survival (PFS) and overall survival (OS).~        -  To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL.~        -  To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.~        -  To assess minimal residual disease (MRD) and correlate it with clinical outcome.~   "
4364|NCT03000114|"~     Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing~     deformities of the hand. Although numerous treatments exist, the most common and widely~     accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery~     time, and many patients require multiple surgeries throughout their life as the disease~     progresses, with repeat surgeries increasing the risk of complications.~      Long recovery times and need for repeat surgeries has renewed interest in minimally invasive~     treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid~     improvement in finger extension with minimal recovery time. The FDA approved collagenase~     clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for~     rapid increase in finger extension, also with minimal recovery time. Currently there is only~     one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes~     in both treatments. Both treatments are minimally invasive, requiring minimal time off work~     and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly~     in patients with multiple areas of disease requiring treatment. The project proposed will~     compare these two methods for treating Dupuytren's disease.~      Approximately 334 participants will be recruited from patients referred for treatment to~     hand surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be~     determined in the usual fashion, and the option for entry into the study will be proposed to~     patients meeting inclusion/exclusion criteria. Participants will be randomized into either~     the PNA or CI treatment group. The surgeon will not be blinded to the procedure group;~     however, the therapist measuring outcomes will be, and the study participants will need to~     not divulge to the therapists which group they are in.~      Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves~     the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle~     inserted under the skin to cut the cord. This is repeated up the length of the cord to~     weaken it, allowing the surgeon to extend the finger and rupture the cord. CI involves the~     injection of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then~     returns to see the surgeon within one week, has freezing placed in the hand, and the~     affected digit is extended to rupture the already weakened cord.~      The patient will be required to present to the hand therapist team for measurements of joint~     angles before and after the assigned treatment is performed. In order to measure treatment~     efficacy, study participants will be required to return for measurements of treated joints~     every 6 months. Lastly, participants will need to inform the performing surgeon or~     therapist, at follow-up visits of any complications they experience.~   "
4365|NCT03000101|"~     The aim of this research is to study the effects of a pomegranate juice on calprotectin~     levels in patients suffering of inflammatory bowel diseases (IBD) in clinical remission.~     Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from~     baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of~     biochemical and molecular inflammatory response markers will be also assessed.~   "
4366|NCT03000088|"~     The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an~     endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this~     study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).~   "
4367|NCT03000075|"~     This is a randomized double blind, double dummy, placebo controlled, parallel design study~     that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).~   "
4368|NCT03000062|"~     In this study the investigators want to explore the feasibility and effect of a simple~     intervention provided by primary care physicians on treatment for overweight in general~     practice. Regular patients visiting their ordinary family physician will be asked for~     participation if they comply with the inclusion criteria. If so, they will follow a detailed~     food list for 12 months with regular visits to the doctor. At each visit, the participating~     patients will be asked about their progress on weight loss and all measurements will be~     made. Simultaneously a control group of primary care physicians will also recruit patients~     that fulfill the inclusion criteria. These patients will also provide data that will serve~     as Control to the intervention group.~   "
4369|NCT03000049|"~     With a completely bedside blood culture diagnostics system (BACTEC blood culture system in~     combination with the Accelerate ID/AST System) it is possible to optimize the initial~     antimicrobial therapy in patients with sepsis and septic shock.~      Prospective observational, open-label mono-center study to compare a completely bedside~     blood culture diagnostics system (BACTEC blood culture system in combination with the~     Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics~     in patients with sepsis or septic shock.~   "
4370|NCT03000036|"~     Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva,~     Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed~     left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late~     gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each~     DOX-cycle.~   "
4371|NCT03000023|"~     The study is both qualitative and quantitative, gathering patient's perceptions of HCV~     treatment benefits before and after HCV treatment by administering surveys and conducting~     in-depth qualitative patient interviews. The study seeks to understand all anticipated and~     actual benefits patients perceive before and after viral eradication.~   "
4372|NCT03000010|"~     The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted~     closure (VAC) therapy in the prevention of infection after posterior spinal fusion for~     pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.~   "
4373|NCT02999997|"~     Parkinson's disease (PD) is typically associated with cognitive and movement related~     functional disabilities. One commonly described cognitive complaint is the ability to do~     several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner~     Method (RGM) is a rhythm and music based rehabilitation intervention that includes~     components that will train this ability specifically in addition to postural control, motor~     learning, movement ability and general cognitive function. The aim with the present~     randomized controlled single-blinded trial is to evaluate the RGM with main focus on~     dual-task performance, compared to a control group, in individuals with PD. The control~     group will continue with everyday activities, including ordinary exercise activities, with~     no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post~     intervention. Following outcome measures will be analyzed:~        1. dual task performance (motor-motor, and motor-cognitive)~        2. level of physical activity, motor function and balance~        3. cognitive function including memory and spatial function~        4. health-related quality of life, fear of falling, and freezing of gait~        5. qualitative interviews from focus group discussions~   "
4388|NCT02999802|"~     This research seeks to better understand how cellular and molecular bases of changes~     associated with aging contribute to decreased function and increased incidence of disease.~     Specific mechanism in muscle responsible for anabolic resistance - a key component of~     sarcopenia and frailty - will be identified. The proposed research is relevant to public~     health because the discovery of new targets for interventions and novel therapeutics to~     improve muscle strength and function, prevent falls, and reduce physical dependency will~     improve the healthspan and quality of life in older adults by improving their physical~     function and ability to remain independent and healthy for a longer period of time.~   "
25856|NCT02718716|"~     The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665~     is safe and tolerated in subjects with primary immune thrombocytopenia.~   "
4376|NCT02999958|"~     Upon collection, human oocytes are fertilized and culture up to the blastocyst stage,~     followed by transfer and / or cryopreservation. Culture media systems have been developed~     that support each step of this process. Although these culture media systems try to mimic~     the natural environment, several components of the in-vivo situation are not present in~     today´s media. One such component is anti-oxidants that may protect embryos against damage~     by reactive oxygen species.~      This investigation aims to compare blastocyst development using 2 different types of culture~     media systems, one of which contains antioxidants. Patients having at least eight oocytes~     and meeting other inclusion criteria can be included in this investigation.~      It is a prospective randomized multicenter study randomly dividing oocytes into two groups~     and assessing parameters of embryo development from fertilization up to blastocyst formation~     until day six. Embryos with acceptable developmental characteristics can be transferred into~     the uterus or cryopreserved for later use.~      The investigation is designed as a superiority study comparing utilization rate of~     blastocysts per normally fertilized oocyte using both media systems. In patients receiving~     embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound~     after 12 weeks gestation is the final endpoint of the investigation.~   "
4377|NCT02999945|"~     In this prospective randomized controlled multi center trial the investigators stratify~     Very Low Birthweight  (VLBW)-infants with growth retardation in small for gestational age~     (SGA) or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact~     of a nutritional management with enhanced nutrients from discharge up to the 52nd week of~     postconceptional age on growth, body composition, metabolic programming, metabolomics,~     microbiome and long term neurodevelopmental outcome. In this study, the investigators will~     evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The~     investigators will further longitudinally assess, how different nutritional interventions~     affect the altered pathways in the first year of life and identify, in combination with data~     available from metabolic markers, microbiome and breast milk analysis, potential pathways~     resulting in increased disease risk later in life.~   "
4378|NCT02999932|"~     Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced~     the mortality in patients staying longer than 72 hours in ICUs.~   "
4379|NCT02999919|"~     Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,~     dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.~     Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue~     reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space.~     Therefore, this study investigated the influence of body mass index (BMI) on PDPH in~     elective caesarean section patients in whom 27G spinal needles were used.~   "
4380|NCT02999906|"~     This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind,~     placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are~     currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at~     randomization for their PAH. Once randomized, subjects will return for 5 study visits up to~     Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will~     transition to the open-label period of the study for up to 20 weeks.~   "
4381|NCT02999893|"~     The purpose of this study is to determine whether APR-246, 5-FU and cisplatin are safe and~     effective in the treatment of platinum resistant oesophageal cancer.~   "
4382|NCT02999880|"~     the importance of this study is to evaluate the clinical performance of direct anterior~     resin composite restoration constructed using innovative esthetic dual-shade technique and~     another restoration constructed using polychromatic natural layering technique with various~     finishing and polishing steps.~      The benefit from carrying out this study is to help the practitioners to decide the most~     suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with~     superior clinical performance direct anterior resin composite restoration.~   "
4383|NCT02999867|"~     This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean~     intervention for health improvement in patients with type 2 diabetes.~   "
4384|NCT02999854|"~     The primary objective of this study is to compare safety and efficacy of a haploidentical~     T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell~     replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in~     patients with a hematologic malignancy. An additional objective of the study is to compare~     the effect of the two treatments on quality of life.~   "
4385|NCT02999841|"~     Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity~     (24kg/m2 ≤ body mass index ≤ 30kg/m2).~      50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle~     combination), using abdominal computed tomography scans and other methods to evaluate the~     effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity~     patients with newly diagnosed type 2 diabetes.~   "
4386|NCT02999828|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD)~     worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its~     infection occasionally leads to severe diseases and death, with central nervous system (CNS)~     damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine.~      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished~     phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on~     the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%~     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July~     2016. The purpose of phase IV is to evaluated the safety and efficacy of the inactive EV71~     vaccine in large scale population of Chinese children (from 6 to 71 months old).~   "
4387|NCT02999815|"~     To establish whether the addition of intrathecal tetanus antitoxin reduces the need for~     mechanical ventilation in patients with tetanus~   "
4389|NCT02999789|"~     To conduct a pilot test to estimate the effect of a novel reminder system in improving daily~     asthma controller medication adherence rates in children with monolingual Spanish-speaking~     guardians who have limited English Proficiency (LEP).~   "
4402|NCT02999620|"~     To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as~     compared to placebo when consumed with a standardized radiolabeled fatty meal.~   "
4390|NCT02999776|"~     The purpose of this study is to assess the feasibility and safety of topical administration~     of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate~     plaque-type psoriasis.~      While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis~     (accounting for around 30% of the cases) become available each year, there are few~     innovations for topical therapies to treat mild/localized psoriasis (accounting for around~     70% of the cases). Given that only about half of the patients respond adequately to the~     current standard of care, the topical application of a fixed combination of calcipotriole~     and betamethasone, there is a medical need for better topical therapies.~      Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in~     children and adults for more than a decade. Its standard route of application is through~     subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg~     per week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a~     well-established favorable long-term safety record, with injection site reactions (pain,~     swelling) the most frequently reported side effects. However, rare but serious side effects~     such as serious opportunistic infections resulting from immune system inhibition common to~     anti-TNF agents limit its systemic use to these patients. For this reason, a localized~     topical alternative route of administration would be desirable. However, the large molecular~     size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE~     certified ablative fractional laser (AFL) device with Er:YAG source will be used to create~     micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.~   "
4391|NCT02999763|"~     Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the~     SlimShape device for non-invasive abdominal fat and circumference reduction.~      Study subjects will undergo SlimShape treatments on the abdominal area.~   "
4392|NCT02999750|"~     The purpose of this study is to prospectively validate treatment benefit of an~     individualized treatment concept based on molecular profiling (MP) from paraffin-embedded~     tumor tissue sections obtained before the start of treatment (real time biopsy).~   "
4393|NCT02999737|"~     The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy,~     generating interest across a wide variety of medical specialties, such as orthopedics,~     dentistry, ophthalmology, and dermatology. Several recently published studies have~     demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair~     loss), but each varies in the treatment protocol, and there is no evidence-based data to~     date guiding the dosing parameters of and intervals between injection sessions. We propose a~     single-center, single-blinded randomized pilot trial to investigate the most beneficial~     number and frequency ('schedule') of necessary PRP injections in men and women with~     androgenetic alopecia.~   "
4394|NCT02999724|"~     Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown~     that this medication can help reduce pain after surgery, including hysterectomy, where the~     uterus or womb is removed. Opioids are the first choice for pain medication administered~     after surgery, but carry significant side effects. Several studies have demonstrated that if~     patients are given gabapentin before surgery, they require less opioids after surgery.~     However, there have not been any studies examining gabapentin's effects on post-operative~     pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence.~     Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore~     patients experience a bulge or pressure in the vagina. Patients with these conditions~     are typically offered medical treatments, but some may require surgery, and this usually~     consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any~     concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to~     patients undergoing urogynecologic surgery on their pain levels after surgery, including the~     amount of opioid pain medication required. We hypothesize that the patients who receive~     gabapentin before surgery will require significantly less opioids.~      Over a six-month period, patients seen in Urogynecology clinics will be invited to~     participate in the study. Women who are already on gabapentin for other reasons, have an~     allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand~     spoken English will be excluded from the study. After providing informed consent, they will~     be randomized to either receive gabapentin or a placebo pill. They will receive the standard~     surgical care, including the usual anesthesia for surgery and routine pain medications~     available after surgery. We will then compare the differences in opioid consumption in the~     first 24 hours after surgery as well as the time from the end of surgery to leaving to the~     recovery room and the length of recovery room stay between the gabapentin and placebo~     groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as~     rated by the patients in each group.~   "
4395|NCT02999711|"~     Purpose of this study is to assess the safety and tolerability of multiple ascending~     subcutaneous doses of REGN3500 to moderate asthmatics.~   "
4396|NCT02999698|"~     The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis~     suppurativa on patients, in order to compare both pathologies.~   "
4397|NCT02999685|"~     Regular physical activity has been found to be important in maintaining health and~     well-being in people with COPD. The purpose of this study is to test new technology and~     health coaching aimed to help people with COPD become more physically active in their daily~     lives.~   "
4398|NCT02999672|"~     This multicenter, non-randomized, Phase II, single agent study will assess the efficacy, and~     safety of trastuzumab emtansine in participants with HER2-positive (immunohistochemistry~     [IHC]3+ in greater than or equal to [>/=] 30 percent [%] of tumor cells) locally advanced or~     metastatic UBC or metastatic pancreas/cholangio cancer. Participants must have received at~     least one prior (for bladder cancer platinum-based) treatment for inoperable, locally~     advanced or metastatic tumor. Participants will receive intravenous (IV) infusion (infusion~     duration=90 minutes [mins]) of trastuzumab emtansine until unacceptable toxicity, withdrawal~     of consent, disease progression (PD), or death, whichever occurs first.~   "
4399|NCT02999659|"~     The pupilometer determines the alteration of the pupil diameter after a defined light~     stimulus. In this study data is collected from pupilometer measurements of patients with an~     acute cerebral disease. The measurements take place during daily neurological routine~     examinations. The values are compared to outcomes resulting from pupilometer measurements~     done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without~     symptoms). The study aims to establish the not invasive method of pupillometry for detecting~     neurological degradations early.~   "
4400|NCT02999646|"~     The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1~     in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead~     tumor cells from the patient itself and genetically modified cells within a capsule. The~     whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected~     underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9~     the capsules are removed again. The patients are then followed-up for 5 years.~   "
18302|NCT02817776|"~     This is a prospective, multicenter, non-randomized clinical evaluation utilizing the~     THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.~   "
4403|NCT02999607|"~     With this study we will be able to dose-dependently measure real-time glucose metabolism~     changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used~     target in therapeutic tDCS applications. This will provide further insight if and how tDCS~     is capable to change one of most reliable parameters of brain metabolism.~   "
4404|NCT02999594|"~     Tramadol for labor analgesia: a low risk placebo controlled randomised control trial~   "
4405|NCT02999581|"~     The purpose of this study is to examine the effects of a pre-workout dietary supplement~     during resistance training on training adaptations.~   "
4406|NCT02999568|"~     The purpose of this study is to examine how different levels of physical activity impact the~     ovarian reserve during the pre-menopausal period~   "
4407|NCT02999555|"~     A molecular study of follicular fluid aspirated from ovarian follicles during routine in~     vitro fertilization treatment, after the eggs were identified and separated.~   "
4408|NCT02999542|"~     The researchers are conducting a research study to see whether listening to music during an~     operation will have a positive effect on the way that children wake up from~     surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and~     screaming (known as emergence delirium). Research have shown that music decreases anxiety~     and pain. The researchers want to see whether music can also influence a child's behaviour~     after emerging from anaesthesia. In other words whether they will be more calm and~     cooperative after listening to music while they are asleep during surgery. Should music have~     a positive effect, anaesthesiologists may use it in future to improve care of patients~     coming for surgery.~   "
4409|NCT02999529|"~     Cancer patients are presented with a lot of information about their diagnosis and different~     treatment options, which can be confusing. The purpose of this study is to see if a simple~     video explanation of six words used to describe cancer treatment improves patient~     understanding of these words.~   "
4410|NCT02999516|"~     Subjects participate in a motor learning training with a special bicycle. The experimental~     group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest~     where they use motor imaginary. The control group proceed equal except for the motor~     imaginary intervention.~   "
4411|NCT02999503|"~     In this study the investigators aim to investigate the relationship between environmental~     factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD).~     Initially the investigators intend to measure the relationship between nutritional quality,~     exercise and sleep and ADHD symptoms. And then measure whether a change made in the diet can~     improve the symptoms of ADHD.~   "
4412|NCT02999490|"~     Clinical examinations are difficult to discriminate between vegetative state and minimally~     conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not~     been established in a clinical setting. we will do a forward study of PET imaging in~     disorders of consciousness patients, and validate with clinical assessments with the coma~     recovery Scale-Revised(CRS-R).~   "
4413|NCT02999477|"~     This research study is exploring chemotherapy in combination with immunotherapy (a therapy~     that uses the body's own immune system to control cancer) as a possible treatment for~     hormone receptor positive breast cancer.~      The interventions involved in this study are:~        -  Pembrolizumab (MK-3475; Keytruda™)~        -  Nab-Paclitaxel (Abraxane~   "
4414|NCT02999464|"~     The purpose of this study is to compare the effects of qigong practice with fitness exercise~     on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life~     of stroke survivors.~   "
4415|NCT02999451|"~     POEM is a new intervention for the treatment of achalasia and has been reported to relieve~     the dysphagia symptom effectively. Although the cost of POEM method is less than the method~     of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the~     patients with achalasia. In this trial, investigators plan to use snare to assist POEM~     procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared~     with other knifes-assisted procedure.~   "
4416|NCT02999438|"~     Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to~     decreased resistance to stressors and is associated with adverse health outcomes. The~     syndrome has been well studied in adults and is quantified by the Fried criteria, which are~     comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and~     diminished physical activity. The concept of frailty is novel in children. A study in young~     adult childhood cancer survivors demonstrated increased incidence of frailty in this~     population along with increased risk of morbidity and mortality. This suggests that frailty~     as a phenotype has relevance outside of the geriatric age group. Pediatric patients with~     single ventricle physiology, heart failure and pulmonary artery hypertension- all represent~     populations with significantly increased risk of mortality, morbidity and decreased quality~     of life. Currently, such patients are monitored outpatient by serial echocardiograms and~     blood work that only gives information about end organ damage. But there is no validated~     tool available to measure global infirmity in such children. Better understanding of the~     relevance and applicability of frailty in pediatrics may allow for identification of the~     most vulnerable pediatric cardiac patients and be of value in optimizing their clinical~     management and improving health outcomes.~   "
4417|NCT02999425|"~     The overall idea to be evaluated in this project is that educational activities providing~     top-notch knowledge on diet and physical activity may represent an additional benefit to the~     strategies aimed at decreasing lifestyle diseases in Serbian population of both young and~     mature age. The specific objectives of this project are:~        1. to develop user-friendly guidelines for physical activity and nutrition for two age~          group cohorts (K-12 and adults) of Serbia residents;~        2. to provide a brief educational intervention about nutrition and healthy lifestyles at~          school or work settings in each age group;~        3. to determine if an educational intervention would yield an additional benefit in the~          acquisition of knowledge on nutrition and physical activity;~        4. to promote and disseminate project results using popular media, non-professional and~          professional bodies and relevant events.~   "
4428|NCT02999282|"~     In this randomized, double-blind, sham-controlled study, the investigators will evaluate the~     effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on~     neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic~     stimulation (TMS), in asymptomatic subjects at risk and symptomatic patients bearing a~     pathogenic Progranulin mutation.~   "
4418|NCT02999412|"~     Background: Mismanaged prescribing and use of medication among elderly puts major pressure~     on current healthcare systems. Performing a medication review, a structured critical~     examination of a patient's medications, during hospital stay with active follow-up into~     primary care could optimise treatment benefit and minimise harm. However, a lack of high~     quality evidence inhibits widespread implementation. This manuscript describes the rationale~     and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for~     evidence.~      Aim: To study the effects of hospital-initiated comprehensive medication reviews, including~     active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and~     2) solely hospital based reviews.~      Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.~      Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.~      Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion~     criteria: Palliative stage; residing in other than the hospital's county; medication review~     within the last 30 days; one-day admission.~      Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with~     the addition of active follow-up into primary care; 3, usual care.~      Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up~     period.~      Data collection and analyses: Extraction and collection from the counties' medical record~     system into a GCP compliant electronic data capture system. Intention-treat-analyses using~     general estimating equation techniques and frailty models.~      Relevance: This study has a high potential to show a reduction in elderly patients'~     morbidity, contributing to more sustainable healthcare in the long run.~   "
4419|NCT02999399|"~     To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the~     metabolism of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in~     current and former smokers~   "
4420|NCT02999386|"~     The clinical relevance of the observed stress induced hyperglycemia in trauma patients~     remains unclear. The earlier studies suggested the implications of cytokines in stress~     induced hyperglycemia and the outcomes after trauma. To date, there is little information~     available regarding the effect of diabetic hyperglycemia (occult or known) on outcomes after~     trauma and whether these patients represent a distinct group with differential outcomes when~     compared to those with stress-induced hyperglycemia. Herein, the purpose of this study is to~     identify the incidence of stress induced hyperglycemia as well as diabetic hyperglycemia in~     trauma patients and to investigate the association between proinflammatory cytokine levels~     and hyperglycemia in our trauma population.~   "
4421|NCT02999373|"~     About 37% of neonatal mortality are caused by infection worldwidely . Excessive application~     of broad-spectrum antibiotics increased drug-resistance, however does not decrease morbility~     and mortality of neonates. Based on the investigator' early in vitro experiments which found~     cord blood mononuclear cells can inhibit bacterial growth and reduce of drug-resistance,~     along with other studies conducted recently from other groups who have reported the~     successful use of umbilical cord blood mononuclear cells in animal sepsis.The investigator~     would like to investigate the effects of umbilical cord blood mononuclear cells on~     prevention effect of preterm infection.~   "
4422|NCT02999360|"~     The purpose of the study is to determine if speech therapy can be enhanced by Aerobic~     Exercise (AE). Investigators will use a single subject design to determine if aphasia~     therapy result in greater gains when combined with aerobic exercise.~   "
4423|NCT02999347|"~     The purpose of this study is to determine the interactions between pregnancy and urinary~     stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub~     studies are:~      Study 1:~      The main aims of Study 1 are to evaluate any potential impact on urinary stress continence~     after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences~     in continence status based on the mode of delivery for these women.~      Study 2:~      The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence~     in women registered in The Norwegian female incontinence registry prior to surgical~     treatment. In addition, we want to explore if there are obstetric risk factors predicting~     failure of a MUS surgery performed after pregnancy/delivery.~   "
4424|NCT02999334|"~     The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe~     resource and staffing shortages. The investigators adapted and piloted an evidence-based~     model of group antenatal care as an innovative way to improve ANC service delivery and~     increase health promotion. This pilot will be conducted in Malawi and Tanzania and will~     provide data to prepare for a large randomized controlled trial to document the impacts that~     group antenatal has on perinatal health outcomes. This study will ultimately inform policy~     and practice aimed at improving quality of antenatal care through respectful and~     woman-centered care to pregnant women.~   "
4425|NCT02999321|"~     Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.~   "
4426|NCT02999308|"~     In the past, due to economic and medical resource constraints, the hemophilia comprehensive~     care in China was suboptimal. The BCH data of both retrospective and prospective studies~     reveals that for 4-6y and 6-9y patients with severe hemophilia respectively: 45% and 82% of~     the patients have suffered from joint bleeding, with mean AJBR of 4.18 and 4.95; and 24.2%~     and 33.3% of them with AJBR>10 times, led to arthropathies and made their quality of life be~     heavy affected. Now, with the development of economy and medical science in China,~     prophylaxis regimens have been initiated in more and more children with hemophilia.~     Considering the difference between prophylaxis regimens, the frequency of joint bleeding was~     reduced significantly, the quality of life of hemophilia kids improved. An assessment~     scoring system for the appropriate validation of individualized prophylaxis treatment~     regimens are urgently needed.~      Before, the most important assessed indication for hemophilia prophylaxis was the frequency~     of joint bleeding. But increasing evidences are showing that there is a discrepancy between~     real joint damage and joint bleeding frequency. The single indicator of joint bleeding~     frequency is not sufficient to evaluate the joint status of hemophilia children.~      Under the World Health Organization's ICF guidelines, the assessment scoring system for~     selecting prophylaxis for children with hemophilia should include the tools currently~     available for assessment of structure/function of the joint, patient activities and patient~     participation in hemophilia healthcare. According to ICF of WHO, the most common bleeding~     parts are elbows, knees and ankles, therefore the assessment of children with hemophilia~     should include the evaluation of the structure, the function of these 6 Index joints, the~     capacity of activities and the capacity of participation of children. These will constitute~     a comprehensive hemophilia evaluation system.~      In China, exploration of the optimal and individualized prophylaxis regimen is urgent, and~     the comprehensive evaluation system should include joint structure and function, body's~     activities and individual participation, thus may be more appropriate for the individualized~     prophylaxis for Chinese children with hemophilia.~   "
4427|NCT02999295|"~     The main purpose of this study is to evaluate the safety and efficacy of the combination~     therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable~     gastric or GEJ cancer.~   "
4920|NCT02992834|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant~     or refractory CD19+ B cell lymphoma.~   "
4429|NCT02999269|"~     Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with~     depressive episodes. During a typical four-week ECT series, most depressive episodes will~     respond to treatment and people will improve their level of functioning (return to work or~     family). Independent of the antidepressant effect of ECT, many patients experience transient~     memory impairment. This investigation will examine the impact of one ECT parameter (pulse~     amplitude or current) on brain changes (structure of connections within the brain) and~     clinical outcomes. The goal of this investigation is to determine the optimal parameter for~     an individual patient that will maintain the clinical response (reduce depression severity)~     and minimize side effects (eliminate memory issues related to treatment).~   "
4430|NCT02999256|"~     The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity~     eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and~     blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry~     juice and placebo in a random counterbalanced order for 20 days. Outcome variables were~     measured immediately pre- and post-supplementation and 10 days after the onset of~     supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat~     oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.~   "
4431|NCT02999243|"~     This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST)~     facilitates sexual harm reduction and reduces HIV transmission among HIV-negative MSM in~     China.The intervention group will be offered HIVST kits plus harm reduction education, and~     followed 9 month, while the control group will receive harm reduction educational material~     only.~   "
4432|NCT02999230|"~     This study will examine the mechanisms of action of probiotics and synbiotics for control of~     oral diseases, with a particular focus on exploring new strategies for caries prevention and~     treatment.~   "
4433|NCT02999217|"~     This 4-week prospective double blind anaemia management study evaluates the effect of~     high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer~     surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly~     assigned to receive either 1 g of intravenous iron or equal amount of saline~     postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other~     haematological parameters over time and profile of clinical recovery.~      The primary end point is that iron isomaltoside given postoperatively is superior to placebo~     in terms of increase and stability of levels of haemoglobin and other haematological~     parameters.~   "
4434|NCT02999204|"~     To evaluate in patients with chronic kidney disease the impact of two dosages of per os~     vitamin D3 supplementation (cholecalciferol) on large arterial stiffness (evaluated non~     invasively by pulse wave velocity and high-resolution echotracking system). We will also~     study arterial calcification (lateral abdominal radiography and echocardiogram), arterial~     remodeling (high-resolution echotracking system), endothelial function (evaluated by a~     non-invasive finger biosensor device), and bone remodeling (evaluated by serum biomarkers~     and bone mineral density).~   "
4435|NCT02999191|"~     The primary objective of this trial is to investigate the relative bioavailability of BI~     1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This~     assessment will be performed under fasted conditions. Furthermore, the effect of food on~     relative bioavailability of the tablet formulation of BI 1467335 will be investigated.~   "
4436|NCT02999178|"~     The aim of the current study is to investigate the efficacy and safety of nintedanib over 52~     weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as~     patients who present with features of diffuse fibrosing lung disease of >10% extent on~     high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms~     or chest imaging have worsened despite treatment with unapproved medications used in~     clinical practice to treat ILD. There is currently no efficacious treatment available for~     PF-ILD. Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is~     anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.~   "
4437|NCT02999165|"~     The purpose of this study is to assess whether two methods of breathing support in babies~     called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive~     Airways Pressure' (nCPAP) are compatible with breastfeeding. Many babies who are premature~     or unwell after birth require help with their breathing. This is often achieved by blowing a~     continuous flow of air through the nose and down into the lungs in order to reduce the~     amount of effort the baby needs to inflate the lungs during breathing.~      Currently some centres allow babies to breastfeed whilst undergoing breathing support whilst~     other centres do not in case there is an increased risk of choking or other harmful events.~     In the latter case, babies are fed using a nasogastric tube (NGT) that runs from the baby's~     nostrils into their stomach.~      At this centre, babies are allowed to breastfeed whilst simultaneously on either HHFNC or~     nCPAP. This is because the concerns over the choking risk are not evidence based. This study~     aims to conclusively prove that thisfeeding protocol is safe and then to expand into other~     areas of research to find out the following:~        -  Whether breastfeeding during nCPAP or HHFNC leads to babies establishing full~          breastfeeding sooner (and subsequently reduce the length of their stay in hospital)~        -  What the effects of breastfeeding of nCPAP or HHFNC are on a baby's parents (e.g.~          whether it enhances bonding)~        -  If nCPAP and HHFNC have different effects on breastfeeding As part of this study the~          investigators will observe stable babies on nCPAP or HHFNC during breastfeeding~          episodes. The investigators will monitor the babies for signs of distress or~          instability and whether they are more stable when breastfeeding is not occurring. This~          will be compared to an episode where the same baby is fed by NGT to see which technique~          is better.~   "
4438|NCT02999152|"~     The aim of this study is to confirm in humans the relevance and the kinetics of~     radio-induced bio-markers in plasma and urines, previously described at the preclinical~     stage.~   "
4439|NCT02999139|"~     Participants who train at The Micheli Center for Sports Injury Prevention, will undergo~     testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular~     endurance. They will complete training with a certified trainer and injury prevention~     specialist until their specific goals are meet. Upon completion of training, they will fill~     out an injury questionnaire every three months for five to ten years.~   "
4440|NCT02999126|"~     The purpose of this study is to determine if a slow stepwise propofol TCI induction with~     Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration~     required for maintenance of the general anesthesia, with propofol and remifentanil, in adult~     populations older and younger than 65 years of age.~   "
4441|NCT02999113|"~     To explore to what extent shared mental models (SMM) occur within the Video-Assisted~     Thoracoscopic Surgery (VATS) teams in a cardiothoracic surgery setting. Additionally, to~     establish whether the VATS team's SMM is associated with the surgeons' technical skills,~     procedural specific times, per-operative bleeding, or patient characteristics~   "
4442|NCT02999100|"~     The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of~     reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This~     study is being conducted to further assess safety and tolerability of inhaled oxytocin, and~     to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin~     administered as standard of care. Two groups of subjects will be enrolled. Group 1 will~     enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM)~     oxytocin as active management of the third stage of labour (after the baby is born). Group 2~     will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and~     intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will~     evaluate the safety and tolerability of IH and IV oxytocin.~   "
4443|NCT02999087|"~     The purpose of this study is to demonstrate that treatment with avelumab in combination with~     RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab~     alone in terms of progression-free survival (PFS) in front-line patients with locally~     advanced SCCHN.~   "
4444|NCT02999074|"~     The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the~     currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a~     beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics~     or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory~     clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to~     either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a~     waiting list control group that will get no exercise intervention during neoadjuvant CTx~     (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the~     clinical-pathologic stage (CPS-EG) score, which has been shown to be a valid prognostic~     factor with respect to survival after neoadjuvant CTx and is routinely assessed after breast~     surgery. Further, the effects of resistance and aerobic exercise on the pathological~     complete response (pCR), tolerability and compliance to CTx, physical fitness, patient~     reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms,~     anxiety and pain, and selected biomarkers will be investigated.~      First an internal pilot phase of n=33 patients will be conducted. Upon the recruitment rate,~     overall feasibility and funding, it is planned that the study thereafter will directly~     continue as phase III trial (anticipated sample size n=342), possibly after some adaptions~     based on the experiences gained in the pilot phase. No interim analysis or unblinding of the~     pilot data is planned, so that the pilot data can be integrated in the phase III study.~      A confirmation of the study hypothesis would be a strong argument for patients to engage in~     exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based~     guidance for patients regarding type and timing of training.~   "
4445|NCT02999061|"~     The purpose of the study is to determine the prevalence of dental caries in preterm birth~     children aged 2-5 years in primary dentition.~   "
4446|NCT02999048|"~     The purpose of this study is to determine whether panax notoginseng saponins are effective~     in the treatment of Hypertensive Intracerebral Hemorrhage Patients.~   "
4447|NCT02999035|"~     A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular~     surface sensitivity by employing a liquid jet.~      This study aims to validate this new prototype by means of correlating its measurement with~     a previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by~     Murphy et al. 1996) and by exploring the repeatability of ocular surface sensitivity~     measurement.~   "
4448|NCT02999022|"~     This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can~     improve fracture healing and improve patients' function and productivity.~   "
4449|NCT02999009|"~     The purpose of this study is to review the performance and success rate of an FDA approved~     cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study~     will specifically look at the need to revise the hip replacement after 5 years. This will be~     compared to how much this happens in patients who have hip replacement with similar~     cementless acetabular shells.~   "
4450|NCT02998996|"~     The main purpose of the this study is to evaluate the safety and tolerability of Immunose™~     FLU based on Endocine™ and quadrivalent influenza antigen.~   "
4451|NCT02998983|"~     This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma~     that have achieved a complete or very good partial response after standard therapy. An~     additional cohort of children who could not achieve these response criteria or that relapsed~     after standard therapy but do not have progressive disease will receive Racotumomab together~     with metronomic chemotherapy.~      The main objectives of this study are to determine the immune response after one-year~     duration immunization with Racotumomab, to describe the response of Racotumomab therapy in~     minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of~     Racotumomab.~   "
4452|NCT02998970|"~     The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure,~     function and circulating biomarkers in patients with Type II diabetes. Empagliflozin~     (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type~     II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a~     previous post-marketing clinical trial. The use of empagliflozin to treat patients with~     diabetes and heart disease has been approved by Health Canada. However, the process by which~     it may give this beneficial effect remains unclear and needs further investigation.~     Therefore, the aim of this study is to provide a fundamental understanding of the~     mechanistic basis by which Empagliflozin could provide its potential cardio-protective~     effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).~   "
4453|NCT02998957|"~     Introduction:~      Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little~     bitterness reversible airflow causing shortness of breath, chronic cough and sputum~     abnormal. Patients with COPD often suffer exacerbations of their symptoms, particularly~     dyspnea, causing hospital admissions. Recent studies have shown that acupuncture stimulation~     transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with~     COPD.~      Objective:~      The aim of this study was to evaluate the possible utility of adding to the usual treatment~     stimulation AcuTENS in COPD patients admitted with severe dyspnea.~      Methodology:~      Patients who agree to participate will be randomly divided into two groups. The intervention~     group will receive a daily treatment, during the period of hospitalization, 45 minutes~     stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group~     performed the same procedure with a device TENS simulated. The extent of dyspnea in both~     groups as well as the number of days of hospitalization and the number of drugs consumed.~   "
4599|NCT02997124|"~     The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane~     block administered intraoperatively improves the postoperative parameters in patients~     undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if~     there is a decrease in the incidence of chronic pain or numbness at the harvest site.~   "
4454|NCT02998944|"~     This study aimed to explore the associations between constitutions of traditional Chinese~     medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional~     study was performed to investigate the associations. A total of 3748 participants were~     available for analysis in this study. The assessment of constitution of TCM was based on~     recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD~     was based on self-reported medical history. The associations were analyzed using univariate~     and multivariable logistic regression (MLR).~   "
4455|NCT02998931|"~     Glutamine supplementation has beneficial effects on morbidity and mortality in critically~     ill patients, possibly in part through an attenuation of the proinflammatory cytokine~     response and a Immune function. In this trial intensive care unit patients with enteral~     feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.~   "
4456|NCT02998918|"~     Polyphenol supplements, including curcumin and resveratrol, are known to decrease~     inflammation, but previous polyphenol supplements were poorly absorbed and thus their~     effects were reduced. A new phytosome formulation coats the supplements and allows them to~     be better absorbed. The purpose of this study is to examine the acute (1-hr) and short-term~     (1-week) effects of two different phytosome-formulated polyphenol supplements on~     inflammation. The two supplements that will be used are: 1) PolyResveratrol and 2) Curcumin.~   "
4457|NCT02998905|"~     To determine the feasibility of a controlled trial examining the efficacy and safety of~     non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention~     in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.~   "
4458|NCT02998892|"~     Population studies suggest that time spent in sedentary behaviors is associated with~     all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of~     time spent in exercise. Frequent interruptions to sedentary time are however beneficially~     associated with metabolic health outcomes, even in individuals who exercise regularly. The~     goal is to use integrative approach to understand the biological mechanisms that underlie~     these associations in a longitudinal intervention study in overweight sedentary adults. The~     investigators believe that the proposed study will provide an initial evidence base for the~     health benefits of breaking up prolonged sitting with short bursts of activity. This~     innovative strategy may be more effective at combating the adverse effects of sedentary~     behaviors than more traditional approaches.~   "
4459|NCT02998879|"~     The main objectives of the study are to evaluate safety and efficacy of repeated treatment~     with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6~     years~   "
4460|NCT02998866|"~     To determine the correlation between rate of temperature decline and nadir cryoballoon~     temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary~     vein isolation.~   "
4461|NCT02998853|"~     Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI~     patients during first acute procedure~   "
4462|NCT02998840|"~     The purpose of this study is to evaluate and compare the efficacy of B244 in treating~     patients with hypertension.~   "
4463|NCT02998827|"~     The effectiveness of thalidomide in treating inflammatory bowel disease has been widely~     recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on~     ovarian reserve function.Therefore, this study was to investigate the influence of~     thalidomide on function of ovarian reserve.~   "
4464|NCT02998814|"~     The purpose of this study was to evaluate the retention rates of a fissure sealant placed~     using different adhesive protocols over 24 months.Twenty-four subjects with no restoration~     and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different~     adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants~     were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse~     adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with~     acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a~     table of random numbers. Two other calibrated examiners, independently evaluated the~     sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated~     in terms of caries formation being present or absent and retention using the following~     criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was~     used to evaluate differences in retention rates among the sealants for each evaluation~     period.~   "
4465|NCT02998801|"~     To construct and evaluate an immersive 3D simulation to familiarize patients with the~     pre-operative experience, and investigate whether A) immersive 3D virtual reality video can~     reduce pre-operative anxiety, and B) how this approach compares to current practice of~     viewing traditional educational videos.~   "
4466|NCT02998788|"~     This is an prospective study conducted in a Chinese heart failure population. The study~     investigates the effects of cardiovascular disease risk factors such as lifestyle~     behaviors,biomarkers and intermediate diseases on heart failure prognosis.~   "
4467|NCT02998775|"~     E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate,~     or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy~     participants. The primary objective of the study is to obtain plasma from participants for~     use in in vitro protein binding studies.~   "
4468|NCT02998762|"~     The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND~     study population of patients every six months and continuing over a five-year period. This~     will provide information on the longitudinal progress in mood, functioning, and quality of~     life of the CAN-BIND sample with a view towards long-term outcome and treatment.~   "
4469|NCT02998749|"~     The aim of our retrospective clinical study was to examine the association between agonal~     breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim~     was to examine role of basic life support (BLS) and response time. Our hypothesis is that~     agonal breathing has positive effects on both primary and secondary endpoints.~   "
4470|NCT02998736|"~     The purpose of this study is to determine if giving Cialis for 5 days prior to surgery, on~     the day of surgery along with the influenza vaccine and Cialis 10 days after surgery will~     have an affect at the cell level for decreasing the chances of the spread of disease post~     surgery.~   "
5871|NCT02980328|"~     This study aims to evaluate the effectiveness of a self-therapeutic approach of skin~     adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary~     Incontinence (UI)~   "
4471|NCT02998723|"~     Attrition of skills after basic life support (BLS) training is common. Psychology studies~     have established that for basic memory recall tasks, spaced learning strategies improve~     retention. Spaced learning is often organized as a refresher or 'booster' course after~     initial training. This study aims to investigate if this principle holds true for BLS~     skills, which require rapid memory recall and efficient deployment of procedural skills~     while under time pressure.~   "
4472|NCT02998710|"~     The purpose of the study is to characterize the clinical course of Cystathionine~     Beta-synthase Deficiency Homocystinuria (CBSDH) in pediatric and adult patients under~     current clinical management practices~   "
4473|NCT02998697|"~     The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in~     improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia~     (IDA).~   "
4474|NCT02998684|"~     This study will examine whether brain stimulation paired with social skills learning can~     help teenage boys with autism learn how to make and keep friends. Brain stimulation can~     enhance learning in some people. This study involves enrolling in a 14-week training program~     where teenage boys with autism interact in small groups and learn social skills. During the~     14-week program participants will receive active brain stimulation, or non-active~     stimulation (placebo). Before and after this training, MRI scans will be taken to see~     whether the training with active brain stimulation made a different in brain activation.~   "
4475|NCT02998671|"~     The study is designed primarily to assess preliminary efficacy and safety of CJM112 in~     patients with moderate to severe inflammatory acne and to determine if CJM112 has an~     adequate clinical profile for further clinical development. In addition, sustainability of~     response and dose relationship will be explored.~   "
4476|NCT02998658|"~     The aim of this study is to estimate whether the use of the barbed suture facilitates~     laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.~   "
4477|NCT02998645|"~     This is a two-part study, interventional Phase II, single-arm, multicenter, open-label study~     to investigate the efficacy and safety of a combination regimen of eltrombopag and~     cyclosporine in patients with severe aplastic anemia (SAA) as first line therapy and an~     extension with up to 60-months follow-up. All patients will receive eltrombopag for 6 months~     with cyclosporine. Patients who respond (who had overall hematologic response by 6 months)~     will continue tapering down cyclosporine for up to 30 months and will be followed up for a~     post-treatment follow-up up to 60 months by regular clinic visits. Patients who do not have~     an overall hematologic response (non-responders) by the end of 6 month time point will be~     discontinued from the treatment and will be followed up for non-responder post-treatment~     follow-up up to 60 months The usage of eltrombopag and cyclosporine combines two therapies~     with different modes of action. Cyclosporine acts as an immunosuppressant and eltrombopag~     acts as a stimulator of bone marrow progenitor cells. Given that SAA is currently viewed as~     having an autoimmune pathogenesis resulting in bone marrow progenitor cell destruction, the~     combination of eltrombopag and cyclosporine is attractive. Preliminary experience with their~     combined use appears favorable, with no untoward toxicity observed to date.~   "
4478|NCT02998632|"~     -  Patients will be diagnosed to determine whether they are eligible for the inclusion~          criteria of this study or not. Patients who are eligible will start their surgical~          treatment in the next visit after radiographic and surgical site evaluation.~        -  On the day of surgery, each patient will be assigned to either intervention or control~          group, the patients will receive inferior alveolar nerve block and long buccal nerve~          anesthesia. Future implant site will be planned, an incision will be made and flap will~          be reflected along the defective ridge.~        -  Implant fixture/s will be inserted in the previously planned site. Uncovered fixture~          threads and bone defect will be covered by MPM or autogenous bone graft.~        -  In the control group, autogenous particulate bone graft will be used for vertical~          augmentation and covered with titanium reinforced membrane. In the intervention group,~          MPM (Mineralized plasmatic matrix) will be used.~        -  Edges will be approximated, Sutures will be placed.~        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ~          units.~        -  Patients will be referred to the fixed prosthodontics department for placement of the~          crowns after ensuring success of osseointegration and implant stability (after 4~          months).~        -  Patients will evaluate their overall satisfaction after fitting the final prosthesis~          using a questionnaire at 9 months.~        -  After 9 months, CBCT will be performed to evaluate augmented bone height to be compared~          with the bone height previously recorded in CBCT.~        -  Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to~          be compared to the ratio recorded before.~   "
4479|NCT02998619|"~     Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal~     vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010~     and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as~     well as toxicity according to CTCAE v4.03.~   "
4480|NCT02998606|"~     To date, few studies have assessed the effect of opioids on esophageal motility, mostly~     assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a~     large retrospective study assessing the effect of opioids on esophageal motility found that~     esophageal motor dysfunction are common in chronic opioid users whether studied on opioids~     and off opioids. In addition, current opioid users also had significantly higher integrated~     relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli~     2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to~     reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal~     transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is~     the first oral peripherally acting mu opioid receptor antagonists for opioid-induced~     constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced~     constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose,~     MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is~     associated with preservation of centrally mediated analgesia.~      This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient~     population.~      The investigatonal hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced~     esophageal motility disorders~   "
19126|NCT02806921|"~     The purpose of this study is to investigate changes in the level of inflammatory mediators~     in the tear film of scleral contact lens wearers in a keratoconic population.~   "
4481|NCT02998593|"~     This study is a prospective double blind randomized controlled trial to investigate the~     effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation~     in idiopathic oligospermic men .Include patients will take the medicine and placebo in~     different two case and control groups for 3 month and semen parameters and other variants at~     the start and end of study.~   "
4482|NCT02998580|"~     This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst~     stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site~     of stimulation in both treatment conditions. The site of stimulation will be targeted using~     MRI co-registration. The study seeks to determine if the bilateral theta burst protocol has~     similar effectiveness to the conventional bilateral rTMS protocol in treating major~     depression.~   "
4483|NCT02998567|"~     HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110) a Second~     Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients~     with Refractory Solid Tumours. The investigators will be investigating the safety and~     toxicity of the combination.~   "
4484|NCT02998554|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo in the treatment of adults and children with adenoviral~     conjunctivitis.~   "
4485|NCT02998541|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral~     conjunctivitis.~   "
4486|NCT02998528|"~     The purpose of this study is to determine the safety and effectiveness of nivolumab and~     ipilimumab compared to chemotherapy in the treatment of Early Stage Non-Small Cell Lung~     Cancer.~   "
4487|NCT02998515|"~     Taken recent literature together, there is a sufficient number of trials investigating the~     effect of different oxygen devices. However, studies comparing oxygen delivery via portable~     oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing~     and sufficient power are missing.~      Given that walking is the most important activity of daily life to preserve the maintenance~     and to participate in social life, we aim to investigate the effects of two different oxygen~     delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).~      The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking~     capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT~     is that the ESWT is performed at 85% of the individual maximum which is close to the~     intensity of typical daily activities. Due to the fact that the ESWT enables us to determine~     the maximum duration of exercise and to compare values at isotime (at the point of time when~     the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.~   "
4488|NCT02998502|"~     This study will test the efficiency of the Freespira Breathing System in youth.~   "
4489|NCT02998489|"~     This is a randomized controlled trial with infants less than 34 weeks and between 1000 and~     2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral~     advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)~   "
4490|NCT02998476|"~     The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects~     with relapsed or refractory diffuse large B-cell lymphoma.~   "
4491|NCT02998463|"~     This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by~     mother-infant dyads. It has three phases including researcher observation, randomised~     controlled trialing and qualitative midwifery staff perspective. The research will determine~     the effect a facilitating garment has in comparison to conventionally facilitated~     skin-to-skin contact, by measuring its effect on the baby's temperature stability,~     breastfeeding status and weight velocity.~   "
4492|NCT02998450|"~     The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled~     study is to evaluate the safety, tolerability, PK and PD profile of the orally administered~     IMR-687 in healthy adult subjects.~   "
4493|NCT02998437|"~     This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin,~     Amoxicillin.~   "
4494|NCT02998424|"~     Resting pupillary diameter was measured at a randomized Effect-site target concentration of~     propofol used as a sole anesthetic.~   "
4495|NCT02998411|"~     In case of sepsis, the therapeutic success is strongly influenced by the choice of~     anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is~     therefore critical to achieve adequate AI concentration as quickly as possible.~      This protocol aims to define a common framework to studies conducted jointly by the~     Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital for~     various AI in a range of specific study populations (intensive care unit patients,~     neutropenic patients…).~      These studies will use mathematical modeling methodologies to investigate the~     pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets. The~     effects of covariates on PK and PD parameters will be investigated to better explain the~     between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.~   "
4496|NCT02998398|"~     The purpose of this study is to evaluate the effectiveness of the switch from the original~     infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin~     hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic~     condition~   "
4497|NCT02998385|"~     A phase III, multicenter, randomized, open-label, french study comparing:~        -  Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2~          Gy/fraction)~        -  Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) +~          concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)~   "
4498|NCT02998372|"~     Computational simulation will be performed to represent motion of knees with a dislocating~     kneecap. Common surgical treatment methods will be simulated and anatomical parameters~     commonly associated with the dislocation will be varied in order to characterize the most~     appropriate surgical approach as a function of knee anatomy.~   "
4572|NCT02997475|"~     The purpose of this study is to investigate areas of the brain responsible for~     self-regulation in adult women who have never had an eating disorder with women who have~     bulimia nervosa. More specifically, investigators are interested in changes in brain~     activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and~     regulating emotions. Data collection will rely on a technology called functional magnetic~     resonance imaging (fMRI).~   "
4499|NCT02998359|"~     In England each year over 9,000 people fracture their hip. Most of these are elderly females~     with the fracture occurring after a fall. Approximately half of these fractures are~     classified as intracapsular fractures because of their close proximity to the hip joint. The~     majority of these fractures are treated surgically by excising the broken femoral neck and~     removing the femoral head (ball part of the hip joint) and replacing it with an artificial~     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes~     termed a 'half hip replacement' in which only the ball part of the hip joint is replaced.~      An alternative type of hip replacement is the full total hip replacement in which the socket~     part of the joint is also replaced. This is the operation that is used for replacing~     arthritic hips. In recent years there have been a number of randomised trials that have~     compared the outcome for patients with an intracapsular hip fracture treated with either a~     partial hip replacement (hemiarthroplasty) against those treated with a total hip~     replacement (THR). Results to date have suggested slightly better long term functional~     results for those treated with a THR, but it still remains unclear if these benefits are~     offset by the increased surgical complexity of the procedure and the extra cost involved for~     a THR.~      At present the numbers of studies on this topic are too few with limited patient numbers to~     make any definite conclusions. This study aims to add to the research studies by comparing~     the two surgical procedures, to enable orthopaedic surgeons to determine the optimum~     surgical treatment for this common and disabling condition.~   "
4500|NCT02998346|"~     The purpose of this observational study is to measure the number of calories delivered from~     fluids used in continuous renal replacement therapy (CRRT). We are doing this research study~     because the fluids used in this treatment may deliver an important number of calories. In~     the future this could help better estimate how much nutrition patients in the Critical Care~     Unit should get every day from other sources like tube feeding or nutrition through a~     person's veins.~   "
4501|NCT02998333|"~     Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of~     patients with lateral ankle ligament injuries, chronic lateral ankle instability may be~     present. If conservative treatment fails, instability is treated surgically. Anatomic repair~     (also known as the Bröstrom procedure) is the current golden standard for surgical treatment~     of chronic ankle instability. The Bröstrom started out as an open technique and is now also~     performed arthroscopically. Both approaches are considered standard care and provide good~     results. Which approach is best, has not yet been researched. In this study it is~     hypothesized arthroscopic repair provides better functional outcome compared to open repair~     during short term follow-up.~      Objective: The main objective of this study is to compare the functional outcome after~     arthroscopic and open anatomic repair in patients with chronic lateral ankle instability,~     and secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic~     and open ligament repair.~      Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All~     patients willing to participate, from an age of 18 years old, with persisting ankle~     instability for at least 6 months, eligible for anatomic repair.~      Intervention: Both groups of patients are surgically treated with anatomic repair of the~     anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by~     the open approach.~      Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months~     after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a~     difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal~     Important Change = 10 points; 2 per subscale).~   "
4502|NCT02998320|"~     This study measures the proportion of enrolled patients taking the uninterrupted HIV~     post-exposure prophylaxis Genvoya for four weeks~   "
4503|NCT02998307|"~     Objectives: The primary objective is to determine the least frequent CPR training interval~     associated with continued performance of guideline-compliant CPR. The secondary objective is~     to determine whether certain physical characteristics, such as age, gender, exercise~     tolerance, height, and weight may be able to identify HCPs at high risk of being unable to~     perform high-quality CPR.~      Design: Randomized trial to compare the effect of different training frequencies on~     long-term CPR performance.~      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects~     will be randomly assigned to a group that undertakes short CPR assessment and training~     sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months~     (control group) over the course of a twelve-month period.~      Analysis: The proportion of nurses in each group that is able to perform excellent CPR at~     the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR~     session where 90% of compressions are performed with correct depth (50-60 mm), 90% with~     correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also~     be performed where the demographic data of individuals who are unable to perform excellent~     CPR at the twelve-month time point regardless of intervention group are compared against~     those who are successful.~      Conclusion: The results of our study will help determine the longest CPR training interval~     associated with maintenance of high-quality CPR skills to minimize training sessions~     required and decrease associated costs. The results will also generate hypotheses for future~     study about optimizing role assignments and team performance in resuscitation.~   "
4504|NCT02998294|"~     The purpose of this study was to determine the accuracy of one-time respiratory volume~     measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume~     measured by mechanical ventilation in post-operative ICU patients.~   "
4505|NCT02998281|"~     Even if cerebral palsy not directly effect respiratory system, impairment of nervous and~     muscle systems, because of the brain damage, may cause respiratory functions impairment. In~     literature, it has been showed that children with cerebral palsy have decreased respiratory~     muscle strength and associated with trunk control, quality of life and respiratory~     functions. But, there is no study in literature that aims to increase respiratory muscle~     strength in these children. Hence, the aim of this study is to investigate effects of~     inspiratory muscle training on respiratory functions, trunk control, activities of daily~     living, functional exercise capacity and quality of life in children with cerebral palsy.~   "
4506|NCT02998268|"~     This is a randomized, multicenter phase II study of pembrolizumab in combination with~     chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the~     safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation~     in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival~     rate.~   "
4507|NCT02998255|"~     Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines~     recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the~     high-volume PEG still results in lower compliance to the regime and increased cost.~      Some high risk factors for inadequate BP have been identified, including old age,~     constipation, diabetes, the use of narcotics and prior history of inadequate BP. For~     average-risk patients without the high risk factors, the procedure of BP could be easier. In~     the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk~     patients achieved adequate BP. Here investigators hypothesized that compared with the~     standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while~     may be accompanied with better tolerability.~   "
4508|NCT02998242|"~     To study safety and efficacy of apatinib in combination of radiotherapy in patients with~     symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic~     antitumor activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).~   "
4509|NCT02998216|"~     This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after~     bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.~   "
4510|NCT02998203|"~     The study aims to evaluate the hypothesized benefits of a systematic organic diet for~     children, over those of a conventional diet. The specific objectives of this study are to:~     i) Demonstrate the decreased body burden of pesticides for those children consuming an~     organic diet, and ii) Evaluate the effects in specific biomarkers of inflammation and~     oxidative stress in children systematically consuming an organic diet.~   "
4511|NCT02998190|"~     The purpose of this study is to determine the safety profile of single and multiple doses of~     EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and~     multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of~     EB8018 on the healthy male gut microbiome.~   "
4512|NCT02998177|"~     The objective of this study is to determine the association between gut microbiome diversity~     and the characteristics of rebound pain at offset of peripheral nerve block in patients who~     have undergone upper limb surgery. Other purposes of this study are to determine~     associations between gut microbiome constitution and persistent post-surgical pain; and~     describing rebound pain by quantifying its clinical, psychological and neurophysiological~     characteristics in this patient cohort.~   "
4513|NCT02998164|"~     This study evaluates the efficacy of using augmentative and alternative communication (AAC)~     technology for enhancing language development in children who are deaf or hard of hearing.~     Half of the participants will receive AAC technology with their speech and language therapy~     and half will continue with their usual care models.~   "
4514|NCT02998151|"~     The aim of this study is to utilize neurophysiologic assessments, behavioral measures and~     clinical measures to assess how much deficits associated with Fragile X Syndrome from~     pre-dose to post-dose Acamprosate, lovastatin, minocycline and placebo.~   "
4515|NCT02998138|"~     This will be an open label, prospective study to determine the association between specific~     genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain~     perception, postoperative pain, analgesic and side effect responses to perioperative~     opioids, chronic postoperative pain and gene expression in adolescents following major spine~     surgery.~   "
4516|NCT02998125|"~     The intention is to explore whether there are factors, which can help us to understand why~     some patient outcomes, following total knee arthroplasty are not successful and identify~     prediction factors for progression. Assessment of outcomes pre- and post-surgery with~     objective tools is a way to explore prediction tools for good/poor progression and improve~     patient selection and timing for surgery.~      The first aim of this project is determine the psychometric properties of the Arabic Version~     of Oxford Knee Score, including internal consistency, reliability and validity before and~     post-total knee arthroplasty in both males and females in a Middle East population. The~     second aim is to assess the reliability of the Star Excursion Balance Test for measuring the~     dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle~     East patients using the Arabic Version of Oxford Knee Score, physical activity measures and~     performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed~     up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society~     International recommendations.~   "
4517|NCT02998112|"~     To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of~     Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial~     to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the~     efficacy and safety of FMT for patients with moderate or severe UC.~   "
4518|NCT02998099|"~     The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of~     IV rivipansel.~   "
4519|NCT02998086|"~     Parenting a child with cancer is highly stressful. The investigators have designed a~     promising parent-centered intervention to bolster parent resilience and reduce stress and~     distress. This study will test 2 formats of the intervention (individual or group-based) and~     compare them to usual care.~   "
4520|NCT02998073|"~     This research focuses on justice-involved youth with conduct disorder (CD) and a history of~     violence. CD is a youth-limited neurodevelopmental disorder that is commonly associated with~     criminality. Although psychosocial interventions that address impulsivity and self-control~     have been shown to be effective at helping promote prosocial behavior in patients with CD,~     the biological changes that occur as a result of treatment are not well understood. This~     study will explore changes in cortisol (a stress hormone) and the brain function of the~     anterior cingulate cortex (ACC) in response to a common psychosocial intervention (Stop, Now~     and Plan Youth Justice Model). This study will contribute to our understanding of biological~     mechanisms involved in therapeutic gains among youth offenders and thereby inform further~     development of treatment programs for justice-involved youth.~   "
4582|NCT02997345|"~     Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible~     for 40% of preterm births in the United States. The PPROM Registry aims to identify possible~     causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care,~     and to review short term and long term outcomes of affected pregnancies and births.~   "
19269|NCT02805010|"~     The objective of the study is to assess the single dose PK, safety, tolerability and~     immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.~   "
4521|NCT02998060|"~     Computer-based navigation systems were first introduced to spine surgery in 1995 and while~     they have been long established as standards in certain cranial procedures, they have not~     been similarly adopted in spine surgery. Designed to overcome some of the limitations of~     navigation-based technologies, robot-guided surgical systems have become commercially~     available to surgeons worldwide.These systems are rapidly challenging the gold standards.~      The aim is to conduct a prospective randomized controlled trial. The randomized variable~     will be the screw placement technique used. One arm will be treated with lumbar fusion using~     robotic guidance (RG), one arm will receive the same procedure but with a free hand~     technique (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted).~     Intraoperative screw revisions and revision surgery for screw malposition as well as~     clinical patient-reported outcomes to identify any such differences between these methods of~     screw insertion will be assessed.~   "
4522|NCT02998047|"~     1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 as monotherapy~        2. Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR)~        3. Confirm the safety profile of the treatment regimen~        4. Determine changes in plasmocyte, T-cell and MDSC cell populations~        5. Estimate progression-free survival (PFS) and overall survival~   "
4523|NCT02998034|"~     In England each year over 9,000 people fracture their hip. Most of these are elderly females~     with the fracture occurring after a fall. Approximately half of these fractures are~     classified as intracapsular fractures because of their close proximity to the hip joint. The~     majority of these fractures are treated surgically by excising the broken femoral neck and~     removing the femoral head (ball part of the hip joint) and replacing it with an artificial~     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes~     termed a 'half hip replacement' in which only the ball part of the hip joint is replaced.~      There are a number of different designs of hemiarthroplasty that may be used. Some of the~     implants are fixed in place with bone cement whilst the rest are inserted as a press fit~     without the bone cement. The early designs of implant were all press fit but these designs~     have now been shown to be inferior to those implants that are fixed in place with bone~     cement.~      There are however a number of newer designs of implant that are coated with a substance~     (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To~     date these implants have only been compared to the cement fit implants in only one previous~     study. This study found no notable difference between the two types of hemiarthroplasty.~     This study aims to add to the research studies by comparing standard cement fit implant with~     a hydroxyapatite coated press fit implant to assist in determining the optimum surgical~     treatment for this common and disabling condition.~      Both implants to be used in this study are still being used extensively within the United~     Kingdom and worldwide to treat this fracture. The study is therefore using two different~     implants within their recommended area of use, but in which there is uncertainty as to which~     is the best implant.~   "
4524|NCT02998021|"~     The primary purpose of this study is to explore the benefits of vibration dumbbell~     resistance training over standard dumbbell resistance training for improving upper limb~     strength, function and pain among manual wheelchair users with paraplegia.~   "
4525|NCT02998008|"~     It is known from research that long-term exercise exposure in type 2 diabetes had positive~     effects. However, the effect of acute exercise in a patient group with already reduced~     cardiac function is not known.~      In this study, the impact of acute exhaustive high intensity interval training on cardiac~     function will be investigated in type 2 diabetes patients.~      One single session of exhaustive high intensity interval exercise training is expected to~     lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the~     right ventricle of the heart is expected to be more affected than the left ventricle.~   "
4526|NCT02997995|"~     This is an open-label, multicentric, international, phase II trial testing aromatase~     inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10%~     CD8+ T cells in the tumor). The trial includes two sequences: The first part of the~     treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part,~     CD8+ patients will receive 6 months of durvalumab combined with exemestane.~   "
4527|NCT02997982|"~     This study investigates the effects of Valaciclovir treatment to individuals with~     Alzheimer's disease or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open~     pilot trial where 36 participants will receive 4 weeks of Valaciclovir treatment.~     Participants will be investigated using different measures before and after the treatment~     period.~   "
4528|NCT02997969|"~     The purpose of this study is to evaluate the safety and immune response to an HIV clade C~     DNA vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.~   "
4529|NCT02997956|"~     This is a phase IB study design planned to identify the MTD (Maximum Tolerated Dose) of~     Tocilizumab in HCC (Hepatocellular Carcinoma) patients followed by a phase II design~     whereupon the primary objective will be median progression free survival (PFS).~   "
4530|NCT02997943|"~     The overall objective of this study is to use an innovative experimental approach, the SMART~     (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the~     delivery of mHealth tools and traditional treatment components in a stepped program of~     obesity treatments. The SMART approach is a highly efficient strategy for identifying and~     constructing efficacious adaptive interventions: it accommodates sequential decision-making~     based on the participant's response to early weight loss treatment components. The proposed~     treatment package begins with the least expensive components, and for participants~     identified as treatment non-responders, provides sequential step-up of additional treatment~     components. By sequentially delivering treatment components based on participant response,~     SMART permits achievement of the target outcome, weight loss, with least resource~     consumption and participant burden.~   "
4531|NCT02997930|"~     The long-term goal of this study is to evaluate cognitive function preoperatively and~     develop techniques of intervention in the perioperative period which would optimize brain~     function and functional recovery following surgery.~   "
4532|NCT02997917|"~     The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at~     low temperature and 25 g bread) will be studied in a parallel design. The effects of~     education will be tested in two different groups in random order: real versus sham~     education. In each group the responses to a probe meal will be tested on 2 different days~     before and after the intervention. Participants will be instructed to eat a standard dinner~     the day before, to consume a standard breakfast at home after overnight fast, and to report~     to the laboratory, where the probe meal will be administered 3 h after breakfast. Studies~     will be conducted in a quiet, isolated room with participants sitting on a chair. Perception~     will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min~     intervals up to 60 min after the probe meal.~   "
4600|NCT02997111|"~     This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the~     effect of energy drinks on platelet function. Participants' will have blood drawn prior to~     and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.~   "
4533|NCT02996864|"~     College students are in a newly independent phase of life; many of whom encounter unhealthy~     dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy~     Detours is a location-based smartphone application tailored in real-time to a student's~     schedule and locale, and aims to guide students toward healthier eating, exercise, and~     lifestyle choices as a way to prevent the onset of damaging and costly health outcomes.~     Through a randomized control trial, this Phase II project will test the effectiveness of an~     evidence-based smartphone application that will provide students with on-demand,~     location-specific information about healthy lifestyle choices.~   "
4534|NCT02996851|"~     Oral antithrombotic medications (OAM) are used for the prevention and treatment of~     thrombotic disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH)~     may have particularly devastating consequences with high morbidity, disability and mortality~     rates. The efficacy and safety profiles of OAMs are generally assessed in randomized~     controlled trials (RCT), but included patients are often highly selected and may not be~     representative of users in everyday clinical practice in terms of follow-up routines, age,~     gender, drug compliance, and polypharmacy. Moreover, it is often unclear whether or not~     traumatic ICHs are registered and reported in RCTs. Drifts in indications and treatment~     criteria may also be seen in everyday practice and drug discontinuation due to precautionary~     concerns including compliance, fall risk and comorbidity may be forgotten. Collectively,~     these factors may lead to other and potentially higher traumatic ICH rates in general~     clinical use than reported in RCTs.~      The incidence rates of traumatic ICH in patients on OAMs in the general population remain~     unknown. In this nationwide registry based pharmacoepidemiological study we will investigate~     the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008~     through 2014.~   "
4535|NCT02996838|"~     To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
4536|NCT02996825|"~     This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and~     gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive~     ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer~     that has come back. Monoclonal antibodies, such as mirvetuximab soravtansine, may interfere~     with the ability of tumor cells to grow and spread. Drugs used in the chemotherapy, such as~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Given mirvetuximab soravtansine and gemcitabine may work better in treating patients with~     FRalpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple~     negative breast cancer.~   "
4537|NCT02996812|"~     This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of~     single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with~     post-bariatric hypoglycemia.~   "
4538|NCT02996799|"~     For preterm infants, deferred cord clamping has been shown to improve both short term and~     long-term neonatal outcomes without an established harm for both the mother and her~     infant.The interference with resuscitative measures for the neonate or the mother is a risk~     that continued to hamper the implementation of delayed cord clamping in many centers around~     the world.For that reason, the evidence now is seeking a time-honored, yet not adopted~     method of placental transfusion that involves milking of the umbilical cord.~   "
4539|NCT02996786|"~     The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood~     biochemical parameters in male recreational runners.~   "
4540|NCT02997891|"~     The purpose of this study is to investigate the effectiveness of a hip arthroplasty for~     chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive~     performance. It is based on the hypothesis that the combination of chronic pain along with~     relative immobilization causes impairment of cognitive performance. The total hip~     replacement reduces pain, increases the mobility level and finally improves the cognitive~     performance.~   "
4541|NCT02997878|"~     MERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It~     is designed to:~      i) Determine dose safety of ORBCEL-C (selected Mesenchymal stromal cells derived from human~     umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers~      This trial has two main stages:~        -  Stage 1 will determine the maximum tolerated dose that can be administered by observing~          for occurrence of dose limiting toxicity (DLT).~        -  Stage 2 will use the maximum tolerated dose found in stage 1 to and further determine~          safety and activity outcomes of ORBCEL-C.~      Upon completion of this trial we hope to be able to justify and conduct separate, larger~     scale trials using ORBCEL-C.~   "
4542|NCT02997865|"~     This study evaluates stepped care for depression in patients with heart failure (HF). The~     stepped care intervention includes cognitive behavior therapy (CBT), plus antidepressant~     medication when indicated. Half of the participants will receive stepped care and half will~     receive usual care for depression; all participants will receive heart failure self-care~     education and support. The primary aims are to determine whether stepped care is superior to~     usual care for depression, and whether treating depression improves heart failure self-care~     outcomes.~   "
4543|NCT02997852|"~     The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog~     visitation (TDV) in reducing biobehavioral stress responses.~   "
4544|NCT02997839|"~     The role of sleep in patients admitted to the intensive care unit is an emerging field of~     research. There have been studies that show patients in the ICU have poor sleep including~     sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2,~     3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure,~     and frequent arousals for medical care. Not only does poor sleep contribute to reduced~     cognitive function and delirium, but there are also implications for the immune system~     function and wound healing (4). Polysomnography is regarded as the gold standard for sleep~     studies, however it has limited utility in the ICU population (5) and alternative methods of~     sleep analysis need to be investigated to better understand the underlying physiologic~     mechanisms and subsequent cognitive effects.~   "
4597|NCT02997150|"~     NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of~     Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic~     syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy~     via an increased production of regulatory T cells.~   "
4545|NCT02997826|"~     From birth to 5 months, milk is the essential and unique food of the newborn. The French~     National Nutrition Program (PNNS) recommends exclusive breastfeeding up to 6 months and at~     least 4 months for a healthy benefit. However, only 36% of infants 0-6 months of age are~     exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in~     the first few months of life. This decision may be a personal choice or be imposed by~     pathophysiological situations.~      The nutritional requirements of the infant are specific, which implies adequate nutrition.~     Infant formulas and follow-up formulas are therefore complex products, specially developed~     for a group of vulnerable consumers. In fact, the compositional and information requirements~     for infant formula are highly regulated.~      Even clinical studies are not required to market an infant formula, it is important to~     obtain objective date on infant growth. Therefore, this study proposes to evaluate the~     effect of the consumption of an infant formula on the growth of infants from 0 to 6 months~     in comparison with the growth curves of the World Health Organization (WHO).~   "
4546|NCT02997813|"~     This is a retrospective observational cohort database analysis. The study will review~     retrospectively the records of patients undergoing a first peripheral blood stem cell~     mobilization for multiple myeloma in the databases from approximately 15 hospitals which are~     part of the IFM collaborative group. Patient records will be divided into two groups of 50~     patients minimum, maximum 100 patients or up to the number of patient records that could be~     extracted. The first group of patients will have received plerixafor plus G-CSF without the~     administration of chemotherapy as a mobilization strategy and a second group of patients~     will have received cyclophosphamide plus G-CSF as a mobilization strategy.~      All consecutive patients with complete set of data (and who underwent apheresis) treated~     between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete~     data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and~     cyclophosphamide will be included.~      All data that will be analyzed will be extracted from the selected IFM institutions which~     are located in France.~   "
4547|NCT02997800|"~     Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain.~     Opioids however have many unpleasant side effects including nausea and vomiting, itching,~     sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood~     pressure are often attributed to pain. It has been shown that by treating these changes with~     medications such as esmolol, instead of opioids, side effects and time to discharge from~     hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have~     advantages over it. It is more effective at controlling both heart rate and blood pressure~     and it is easier and less costly to use. This study is investigating labetalol in patients~     having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients~     will be treated with one of these drugs during surgery to control heart rate and blood~     pressure and the effects on time to discharge, pain scores, frequency of side effects, and~     narcotic requirements will be observed in the recovery room. It is thought that labetalol~     will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will~     show reduced time to discharge, fewer side effects, and effective treatment of heart rate~     and blood pressure.~   "
4548|NCT02997787|"~     Both pelvic masses and preoperative diagnosis of them have still continued as an important~     investigation subject. It is important to discriminate the diagnoses of leiomyoma and~     adenomyosis before operation especially among infertile patients. Neoplasms can alter~     systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio~     (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete~     blood counter test (CBC). A high NLR has been shown in systemic inflammation, some~     gynecologic and gastrointestinal cancers and some cardiovascular diseases.~      The investigators aim to investigate using new inflammation markers, NLR and PLR, whether~     they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there~     have been no previous reports about the association among NLR, PLR, adenomyosis and~     leiomyoma.~   "
4549|NCT02997774|"~     Having hemodialysis affects the blood supply to various organs in the body including the~     heart and the brain. With time, these effects build up and can affect the way these organs~     function. The investigators have previously shown that the liver (a key organ which works to~     help clean the blood, make proteins and turn all your food into energy) is also affected.~     One of the ways to help protect organs from injury due to dialysis has been cooling during~     dialysis. The investigators want to examine whether cooling during dialysis protects the~     blood supply to the liver. CT imaging will be used to measure this blood supply during~     hemodialysis with standard and cooler settings.~   "
4550|NCT02997761|"~     This phase II trial studies how well ibrutinib and blinatumomab work in treating patients~     with B acute lymphoblastic leukemia that has come back or is not responding to treatment.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of~     cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in~     treating patients with relapsed or refractory B acute lymphoblastic leukemia.~   "
4551|NCT02997748|"~     Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with~     cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by~     implementing remote ischemic preconditioning and to evaluate the dose-response relationship~     using the biomarkers urinary [TIMP-2] *[IGFBP7] in high risk patients undergoing cardiac~     surgery.~   "
4552|NCT02997735|"~     Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms~     children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation~     quitlines are effective in helping smokers quit, but few smokers make use of their services.~     Electronic health record-based systems that automate referral of interested parents to~     quitlines through pediatric settings may increase the proportion of smokers who successfully~     enroll in treatment.~   "
4601|NCT02997098|"~     This observational registry of patients undergoing liver surgery collects patients both~     retrospectively and prospectively. Patients undergoing liver resection for any~     non-transplant indication will be evaluated for clinical outcomes (such as surgical~     complications, survival, and disease progression) based on clinical and patient factors~     (like indication, age, and other treatments for the disease).~   "
5872|NCT02980315|"~     The purpose of this study is to evaluate the safety of the designed LMP1－CAR －T cells and~     determine whether the CAR-T cells are effective in the treatment of EBV associated malignant~     tumors.~   "
4553|NCT02997722|"~     Patients admitted to the University of Mississippi's inpatient psychiatry unit for suicidal~     ideations will be given the opportunity to participate in the study. Within 24 hours of~     arriving to the inpatient psychiatric floor, patients who choose to participate will be~     randomized to receive either a placebo saline infusion or a ketamine infusion of 0.5 mg/kg~     over the course of 45 minutes. Infusions will take place in the University of Mississippi~     Medical Center's Post Anesthesia Care Unit and/or Short Stay Procedure Area. Patients will~     be monitored for 30 minutes after the completion of their infusion. The inpatient psychiatry~     team will assess all patients' suicidal ideations daily while they are inpatient at UMMC and~     the primary outcome will be the patient's inpatient hospital course length.~   "
4554|NCT02997709|"~     Prostate cancer is the most common malignancy in men and nearly 30,000 deaths occur from the~     disease each year. Not only is there significant mortality, there is also considerable~     morbidity from primary and salvage therapies. Understanding which patients require~     intensified treatment, as well as those who might not require treatment, would improve~     outcomes on multiple levels. The cohort to be investigated will be comprised of men with~     intermediate to high risk prostate cancer who are candidates for radiotherapy (RT). The~     overarching objective of the CoMBINe trial is to identify pretreatment and post-treatment~     prognostic and predictive factors derived from quantitative imaging prostate features, tumor~     tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is~     a sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates~     for radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes treated~     with RT to the prostate and limited metastatic sites.~   "
4555|NCT02997696|"~     The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group,~     multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics~     of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the~     knee following 4 weeks of oral administration of ONO-4474.~   "
4556|NCT02997683|"~     In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH~     and CTEPH patients will get a training device to use at home for 3 months. Patients in the~     Intervention group will be introduced in the training program on the wbv-device in the study~     center 3-4 times and baseline Parameters will be collected before start of the home based~     training. Patients randomized into the placebo arm be introduced into the training program~     according to the interventional arm but not perfoming the exercises on the wbv-device but on~     the floor.~   "
4557|NCT02997670|"~     Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients~     with heart failure. However, around one third of suitable patients do not demonstrate~     benefit following device implantation when assessed by echocardiography (heart scanning).~     This group has poorer outcomes.~      Response rate can be enhanced by altering timing delays between the pacing leads, but some~     patients still fail to improve.~      Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles~     increase the number of conformations available to the programmer, allowing multiple vectors~     to be programmed simultaneously or sequentially. This allows programming to avoid, for~     example, a patch of scar and find an area that will respond better to pacing. This technique~     is known as multi-site pacing. CRT is often implanted along with a defibrillator lead in the~     right ventricle, known as CRT-D. The defibrillator lead offers further combinations for~     pacing.~      Goal of Research To evaluate an algorithm for assessing different multi-site pacing~     combinations in optimisation of CRT~      Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation~     for conventional indications at our hospital. At baseline, patients will undergo~     echocardiography, exercise testing and assessments of functional ability and quality of~     life. The device will be implanted as standard. Optimisation will be performed with an~     algorithm using different vector combinations and assessing the heart's efficiency through~     echocardiography and invasive pressure monitoring. The pacemaker will be programmed with~     standard settings. After twelve weeks, the baseline investigations and optimisation~     algorithm will be repeated and the device programmed according to the maximum efficiency.~     After a further 12 weeks, the same parameters will be measured to look for improved response~     to CRT.~      Potential Benefit To increase the response rate to cardiac resynchronisation therapy and~     improve reliability of the technique~   "
4558|NCT02997657|"~     Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for~     poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions),~     while also providing skills that may buffer against stress and negative affect. The overall~     objective of this project is to conduct a randomized controlled trial to test the efficacy~     of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking~     cessation treatment. Participants in both treatment conditions will receive nicotine~     replacement therapy and a validated text-messaging intervention for smoking cessation that~     monitors progress in quitting smoking and extends smoking counseling outside of the~     individual face-to-face context.~   "
4559|NCT02997644|"~     The purpose of this study is to evaluate the use of post-operative opioid use after two~     different educational interventions. The investigators will compare changes in pain,~     disability and sleep between groups 6 months after elective lower extremity surgery.~   "
4560|NCT02997631|"~     Intravenous (IV) insertion is one of the most common procedures for children seeking medical~     treatment in the Emergency Department (ED). This procedure is often painful and distressing~     for children and families. This can result in an uncooperative child, a need for multiple~     cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare~     workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to~     pharmacotherapy, such as distraction therapy.~      Distraction therapy involves engaging children in cognitive tasks in order to divert~     attention from painful stimuli and reduce pain and distress. Currently, distraction therapy~     is not utilized as a standard of care in the ED. Given children's enthusiasm for~     technological devices, we propose that the use of a technologically enhanced device may be a~     more effective distractor and may have a greater impact on pain reduction outcomes of~     patient importance. The primary objective of this study is to compare the reduction of pain~     and distress with the use of distraction (via the MEDi robot) versus current standard care~     in children aged 6 to 11 years who are undergoing IV placement.~   "
4598|NCT02997137|"~     Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.~     These conditions are associated with a deficiency of specific amino acids and micronutrients~     that cause endocrine-cardiometabolic abnormalities. These people have specific~     medically-determined nutrient requirements.~      Aim of this study is to demonstrate, that the daily oral administration of a specific amino~     acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,~     magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly~     decrease the perceived chronic distress and associated chronic exhaustion conditions of~     women and men after 8 and 12 weeks.~   "
25857|NCT02718703|"~     Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of~     a new Blood Glucose Monitoring System.~   "
4561|NCT02997618|"~     Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective~     repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for~     endovascular repair. This risk is associated with poor cardiorespiratory fitness which can~     be measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak~     oxygen uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying~     patients at increased risk of early death after AAA repair.3 These variables can therefore~     be used as surrogate markers for cardiovascular fitness and risk of mortality and morbidity~     in AAA surgery; optimising these markers should improve fitness and decrease this risk. The~     optimal duration and type of exercise training for improving peak VO2 and AT in AAA patients~     is not known. AAA patients are unique as they are motivated to reduce the risk of impending~     surgery but are afforded the time to improve their fitness as repair may not be needed for~     months or even years.~      The investigators propose a pilot randomised controlled trial to explore the effectiveness~     of a 20-week community (either home or gym-based) exercise programme to achieve sustained~     improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL,~     habitual activity levels and cardiovascular risk will also be assessed. The results will~     inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly~     patients with cardiovascular disease and AAA.~   "
4562|NCT02997605|"~     The purpose of this study is to compare the proportion of patients who could withdraw from~     prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a~     hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease~     activity.~   "
4563|NCT02997592|"~     Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A~     prospective, single arm, safety and efficacy, open labeled multi-center study~   "
4564|NCT02997579|"~     Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of~     patellar crepitus after TKA are related to many factors such as femoral component design,~     surgical errors, and postoperative patellar baja. However, it is unclear whether patella~     resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary~     objective of this study are to compare the prevalence of patellar crepitus and the mean~     value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in~     TKA. The secondary objective is to study the association between patellar crepitus and~     vibroacoustic signal.~   "
4565|NCT02997566|"~     Background: the autism spectrum disorders (ASD) can be related with abnormalities in~     cortical structures and cause behavior imbalances. In addition, as soon as the diagnosis is~     done, the better will be the prognosis. In this context, heart rate variability (HRV) stands~     out, which is a non-invasive tool representing autonomic modulation, with potential~     prognostic value. The literature showed there are no changes in HRV at rest using linear~     methods of analysis, but changes can be identified during tasks. Nonlinear methods of HRV~     are more sensitive and provide additional information to the linear. Objective: to analyze~     autonomic modulation using nonlinear and linear indexes of HRV in children with ASD at rest~     and during tasks in comparison to typical children. In addition, to correlate HRV analysis~     between them, also between behavior and severity of the disease. Methods: this study~     involves both typical children and children with ASD. Autonomic modulation will be performed~     using nonlinear indices (extracted from Poincaré plot, detrended fluctuation of tendency~     analysis and recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and~     frequency domain (LF, HF, VLF). The tasks consist in games to identify and recognize faces~     and facial expressions. Behavior and severity of the disease will be evaluated using the~     Autism Behavior Checklist and the Childhood Autism Rating Scale respectively. Statistical~     Analysis: to identify differences between moments and protocols two-way analysis of variance~     will be used along with the Bonferroni post-test or Dunn post-test according to the data~     distribution. Statistical significance will be set at 5%.~   "
4566|NCT02997553|"~     This is a single-center prospective clinical trial to evaluate non-inferiority of~     indocyanine green guided sentinel lymph node biopsy compared with the gold standard~     Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to~     surgery.~      The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope~     (Techniciun99) in the detection of sentinel lymph nodes will be assess using an~     Optonuclear probe (EURORAD S.A.).~   "
4567|NCT02997540|"~     The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently~     measure the position of female breast lesions regardless of patient rotation and probe angle~     during ultrasound examination.~   "
4568|NCT02997527|"~     This study is being done to determine if people with and without GERD or trouble swallowing~     have increased esophageal mucosa impedance (food getting into the esophageal tissue).~   "
4569|NCT02997514|"~     The purpose of this study is to implement Solution Focused Coaching in pediatric~     rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland~     Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set~     and attain personally meaningful goals. A secondary goal is to determine the impact of~     SFC-peds on self-determination in children with neuromuscular conditions. This study aims to~     compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching~     (5 sessions) on goal attainment. This study will also help researchers and clinicians~     understand the types of goals that are set by children with neuromuscular conditions.~     Lastly, this study is going to explore with the participants their perception of the~     feasibility of using this methodology within a clinical context.~   "
4570|NCT02997501|"~     The aim of this study is to evaluate concordance of T790M mutation plasma testing between~     the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess~     the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or~     metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and~     are T790M mutation positive detected by any one of the four plasma testing platforms:~     Cobas/Super-ARMS/ digital PCR/NGS.~   "
4571|NCT02997488|"~     Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes~     provide easier intubation, help intubation difficulty, are used good tool for education.~     McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.~      The purpose of this study is to compare of routine endotracheal intubation with McGrath~     Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier~     and faster intubation.~   "
4573|NCT02997462|"~     There are many treatments that can improve how long and how well people live with heart~     failure when they are outside the hospital. However, the investigators know less about how~     to effectively treat hospitalized heart failure patients so that they do not have to return~     to the hospital after they go home. Part of the problem is that the investigators don't~     understand all of the causes of worsening heart failure.~      Previous studies by other researchers suggest that white blood cells called monocytes are~     over-active in heart failure. Under normal conditions monocytes help fight infections in the~     body, but over-active monocytes release chemicals that could cause abnormal function of the~     heart and blood vessels. The investigators' research group believes that over-active~     monocytes may be an important reason that heart failure worsens before hospitalization.~      In this study the investigators will collect blood samples on the day a patient comes into~     the hospital, the day they return home, and the day they come back to the clinic for a~     follow-up appointment. The investigators will measure the inflammation in the bloodstream~     and the activity of monocytes from the patients' blood to see if there are changes in these~     measurements as heart failure improves. The investigators will also call each patient~     several times after they return home to ask questions about how they are doing.~   "
4574|NCT02997449|"~     Rationale: Accurate staging of lung cancer is important because it directs treatment and~     determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has~     revolutionized radiation therapy for early stage lung cancer and results demonstrate similar~     outcomes in comparison to surgical resection of the lung tumor. The staging work-up program~     for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at~     least a computed tomography (CT) scan of the chest and integrated Positron Emission~     Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal~     staging. However, patients who are treated with SABR do not routinely undergo the same nodal~     staging work-up as do surgical candidates. As both surgery and SABR appear to achieve~     comparable rates of local and regional tumor control, it appears only logical to perform a~     similar staging work-up in all patients with early stage lung cancer who will be treated~     with either of the two curative local modalities. In the past, a lack of invasive nodal~     sampling before SABR was considered acceptable as invasive surgical staging~     (mediastinoscopy) was widely considered the preferred procedure. However, with minimally~     invasive and safe endosonography procedures now available, improved pre-treatment staging~     has become possible for patient groups who are eligible for SABR, including those with~     significant comorbidities.~      Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of~     hilar and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer~     (NSCLC) will result in change of loco-regional nodal status in 20% of patients, in~     comparison to staging by PET-CT alone.~      Study population: Patients with either established or suspected early-stage NSCLC who are~     medically inoperable, or who refuse surgery but are potential candidates for SABR with~     curative intent (provided no intrathoracic metastases are present). Patients will undergo a~     single scope complete mediastinal and hilar staging procedure (combined EndoBronchial~     UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).~   "
4575|NCT02997436|"~     prospective interventional study. The aim is to analyse the effect of usual ongoing~     treatments over the microvascular cutaneous response to galvanic current application~     (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound~     investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of~     aspirin (even at low dose) abolishes the response .~   "
4576|NCT02997423|"~     This is a multi-institutional, consortium-based, non-interventional prospective blinded~     endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in~     tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened~     OS (primary outcome) and PFS (secondary outcome) times.~   "
4577|NCT02997410|"~     This study investigates the efficacy of bio-oxidative ozone application in the treatment of~     TMD of muscular origin.~   "
4578|NCT02997397|"~     In this study, the investigators aimed to find out the effect of a novel tourniquet~     technique, in cases of excessive bleeding during cesarean delivery.~   "
4579|NCT02997384|"~     This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to~     informing women about their risk of breast cancer and the screening methods recommended for~     them according to the recommendations in force during a routine consultation at a general~     practitioner, a gynecologist or a radiologist.~   "
4580|NCT02997371|"~     Traumatic brain injury (TBI) is a common condition with high degree of morbidity and~     mortality (Hyder et al., 2007). Current treatment paradigms for TBI focus on mitigating~     secondary injury and maintaining cerebral physiology (Carney et al., 2016), however, there~     are currently no approved drugs that target the underlying conditions for patients suffering~     from TBI (Bullock et al., 1999). It is increasingly recognised that the innate inflammatory~     response to TBI may inflict injury (Lucas et al., 2006), and one of the most prominent~     mediators of inflammation in the injured brain is the Interleukin-1 (IL-1) receptor pathway~     (Allan et al., 2005). An endogenous antagonist to IL-1, is available in recombinant form~     (IL-1ra, Kineret), and is known to be safe in TBI (Helmy et al., 2014).~      In order to fully understand, and potentially optimize, the effect of Kineret, the~     investigators wish to conduct a dose-response study by giving three cohorts (n=20 per group)~     either placebo (isotonic saline), 1.5g or 3.0g of active substance administered~     intravenously in a double-blind, randomized setting. The concentrations have in previous~     studies not been shown to present any side-effects (Singh et al., 2014). The drug will be~     provided within 12 hours after trauma. The goal will be to provide a dose-response effect on~     the cerebral inflammatory response. As secondary goals, the investigators will assess the~     brain damage by measuring proteins in blood and cerebrospinal fluid, functional outcome and~     inflammation in the brain using positron emission tomography.~   "
4581|NCT02997358|"~     The objective of LMS04 study is to better define the treatment strategy for patients with~     metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first~     line therapeutic option for these patients. LMS04 will test a new strategy for first line~     therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the~     interest of the association of trabectedin to doxorubicin in first line treatment followed~     by trabectedin alone for non-progressive patients after 6 cycles of the association of~     trabectedin and doxorubicin (the LMS02 design).~      LMS04 will be the first phase III randomized study specifically dedicated to soft tissue~     leiomyosarcoma in first line metastatic disease.~      It is planned to compare a new doxorubicin combination (including trabectedin) with very~     encouraging results followed by trabectedin maintenance therapy for non-progressive patients~     to doxorubicin alone. Prospective ancillary translational studies will attempt to define~     profiles of patients who could benefit from this new chemotherapy in an exploratory way.~      The validation of a new first line option specific for LMS, identifying clinical factors~     that characterize aggressiveness and responsiveness to treatment aims to have an important~     in the spirit of personalized medicine in this rare and deadly disease.~   "
4583|NCT02997332|"~     The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized~     trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are~     conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction~     chemotherapy is important without increase toxicities. Durvalumab is a promising agent in~     SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is~     unknown.~      The aim of the study is to evaluate the feasibility and the safety of the association of DCF~     (standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and~     durvalumab are different, so the expected toxicities should not be additive. The addition of~     durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of~     patients with SSCCHN.~      Concerning the translational research, the aim will be to explore the relationships between~     immune capacity, specificity, activation state and clinical outcome to help elucidate the~     determinants of response to immunotherapy.~   "
4584|NCT02997319|"~     The purpose of this study is to determine whether night time eating that coincides with~     elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the~     MTNR1B risk allele.~   "
4585|NCT02997306|"~     This is a randomized, controlled, prospective study which relies on computer-assisted skin~     image processing of scar photographs, to establish whether simple interrupted or running~     sutures are associated with the greatest degree of erythema when used to repair surgical~     defects arising from Moh's micrographic surgery (MMS) of facial skin cancers. Furthermore,~     through the use of the customized software that the investigators have developed for this~     purpose, an effort will be made to better understand the evolution (including progression~     and subsequent regression) of erythema over time in these scars.~   "
4586|NCT02997293|"~     The Enhanced Recovery After Surgery system for perioperative care of patients undergoing~     major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon~     named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal~     surgery were hospitalized postoperatively for extended periods of time due to prolonged~     return of the normal intestinal physiology and of other bodily functions. He formulated a~     system of perioperative care that focused on preserving and promoting faster return of~     normal physiologic function of the human body following surgery.~      The Enhanced Recovery After Surgery system has been implemented in the United States for~     nearly a decade now, primarily at major academic institutions. Numerous publications exist~     that report the dramatic positive impacts of this program on reducing postoperative hospital~     length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.~      The University of Arkansas for Medical Sciences implemented several components of the~     Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an~     observational study to look at the impact that program (Group 1) in shortening hospital~     length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale~     scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day~     readmission when compared to patients who had colorectal surgery performed at University of~     Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After~     Surgery system (Group 2).~   "
4587|NCT02997280|"~     Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic~     stem cell transplantation, while steroid-refractory chronic GVHD significantly increases~     morbidity, aggravates quality of life and may also impact survival. Currently there is no~     standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK)~     inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate~     and survival of patients with either acute or chronic srGVHD. This study prospectively~     evaluates the efficacy of ruxolitinib in srGVHD patients.~   "
4588|NCT02997267|"~     The aim of the study was to compare the restoration of the GI tract by the closure of~     protective ileostomy after low anterior resection for rectal cancer after 14 days and more~     than 3 months.~   "
4589|NCT02997254|"~     This is a cohort study to evaluate algorithms for mapping atrial fibrillation and for~     detecting rotational activity.~   "
4590|NCT02997241|"~     The purpose of the study is to determine the relationship between change of gene copies and~     recurrence，and the overall survival at 5 years after chemotherapy based on clinical~     prognosis compared to Oncocare detection prognosis.~   "
4591|NCT02997228|"~     This randomized phase III trial studies how well combination chemotherapy, bevacizumab,~     and/or atezolizumab work in treating patients with microsatellite instability-high~     colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy,~     such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Monoclonal antibodies, such as bevacizumab and~     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving~     combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients~     with colorectal cancer.~   "
4592|NCT02997215|"~     This study was to evaluate the effect of intraoperative intravenous lidocaine on~     postoperative pain management after laparoscopic cholecystectomy. Half of patients will~     receive intravenous lidocaine during procedure, the rest half of patients will receive~     regular anesthesia care and placebo treatment.~   "
4593|NCT02997202|"~     The purpose of this study is to compare relapse-free survival between participants with~     FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem~     cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after~     the time of engraftment for a two year period.~   "
4594|NCT02997189|"~     This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of~     OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from~     cisplatin chemotherapy regimens in the treatment of cancer.~   "
4595|NCT02997176|"~     This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in~     patients with advanced solid tumors and impaired hepatic function.~   "
4596|NCT02997163|"~     This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients~     with advanced solid tumors and impaired renal function.~   "
4622|NCT02996734|"~     The purpose of this project is to present the outcomes of patients with giant cell tumor of~     bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.~   "
4602|NCT02997085|"~     Virtual Reality (VR) is one non-pharmacological method that has shown promise as an~     effective means of decreasing pain levels following treatment, and for significant periods~     of time. Additionally, neurobiology studies of VR have demonstrated a decrease in brain~     activity associated with pain. While VR is clearly a promising, drug-free option for pain~     treatment, existing VR systems are expensive and use unconvincing graphics. Recent advances~     in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and~     more affordable delivery systems) allow the development of more realistic and more~     cost-effective applications. Capitalizing on these advances and the investigators'~     experiences with VR intervention development and evaluation, the current study will test a~     state-of-the-art VR experience in pain management intervention (Live-Action 360° Video~     Virtual Reality(VVR)) and compare it to established standard computer generated imagery~     (CGI) 360° VVR content for pain management intervention in a medical setting. The~     participant's participation will help the investigators determine which VR intervention is~     most effective in reducing acute pain in hospital patients.~   "
4603|NCT02997072|"~     The purpose of this study is attempt to establish optimum drive pressure of high frequency~     jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by~     electrical impedance tomography.~   "
4604|NCT02997059|"~     This was prospective study randomized in two controlled parallel groups verum versus~     placebo. The objectives were to assess the influence of antifungal treatment with~     Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational~     was based on our previous research having established i) a link between intestinal~     inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human~     digestive tract- ii) the demonstration that this yeast species could be at the origin of~     ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could~     lower the rate of ASCA and/or reduce the occurrence of recurrences.~   "
4605|NCT02997046|"~     Conventional vascular imaging techniques are often either contra-indicated in chronic kidney~     disease (CKD) patients due to their relative invasiveness, risks and cost. Computed~     tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may~     precipitate significant worsening of renal function and even prompt the need for institution~     of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has~     been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging~     methods also have drawbacks: for example, this frail patient group has a higher risk of~     complications from conventional invasive catheter-based angiography, non-contrast-enhanced~     MRA allows visualization of smaller arteries but is less accurate for larger vascular~     structures, and ultrasound is often not appropriate for evaluation of the deep vessels of~     the abdomen and pelvis.~      Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a~     semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging~     (MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for~     the treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI~     contrast agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast~     agent in patients with estimated glomerular filtration rates <30mL/min and there are reports~     in the literature for its safe use and utility in both adult and pediatric patients with~     CKD.~      Participants will be selected from those who have been referred for assessment prior to~     kidney transplant or prior to vascular access creation for haemodialysis and will be divided~     into three groups. The first group will include patients who will undergo a CTA of abdominal~     and aortoiliac vasculature as part of their preparation for potential kidney~     transplantation. The second and third groups will include patients who are having a fistula~     or a graft created for dialysis, respectively. These patients are routinely having US~     vascular mapping to visualise the blood vessels before a fistula or a graft is created.~     Additionally, patients included in the second and third groups are routinely having~     surveillance scans of their fistula or graft at 6 weeks following creation. Study~     participants undergoing standard imaging tests as part of their clinical care will also have~     ferumoxytol-enhanced MRA (FeMRA).~   "
4606|NCT02997033|"~     Population-based, longitudinal cohort study designed to evaluate changes in bone mineral~     density, bone geometry, body composition, parameters reflecting muscle force, and sex~     steroid status in healthy young men, as well as their interactions, over a period of +-10~     years.~   "
4607|NCT02997020|"~     The purpose of this study is to establish the novel endoscopically-directed sinus potential~     difference (EDSPD) assay as an endpoint for therapy of sinus disease.~   "
4608|NCT02997007|"~     Healthy ageing and pathological ageing in the context of a neurodegenerative disease are~     both associated with changes in brain network integrity. Episodic memory is especially~     affected in Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the~     memory-relevant brain networks are especially altered. Transcranial direct current~     stimulation (tDCS) has previously been implemented in different clinical- and non-clinical~     settings and has shown to beneficially influence network connectivity. The neural correlates~     of single-session tDCS have been investigated, however, the neural effects of repeated tDCS~     remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated~     tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a~     treatment option in future studies.~   "
4609|NCT02996994|"~     This is a retrospective chart review using TriHealth Electronic Privacy Identification~     Center (EPIC) and previously developed databases for TriHealth Institutional Review Board~     (IRB) approved research studies within the Division of Urogynecology and Reconstructive~     Pelvic Surgery to determine the predictors of postoperative pain specific to the~     urogynecologic patient population.~   "
4610|NCT02996981|"~     This is a retrospective chart review using Electronic Privacy Identification Center (EPIC)~     database to determine if the addition of cranberry juice capsules to our discharge~     medication regimen for patients discharged home with an indwelling urinary catheter~     following pelvic floor gynecology surgery reduced the incidence of UTI.~   "
4611|NCT02996968|"~     This study is to determine if self-discontinuation of transurethral foley catheters in~     patients diagnosed with postoperative urinary retention (POUR), which is defined as the~     continued need for catheterization, following impatient pelvic organ prolapse surgery is~     non-inferior to office-discontinuation.~   "
4623|NCT02996721|"~     This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (>40 ng/mL)~     among myocardial infarction patients will result in a reduction of cardiovascular-related~     adverse events. Half of the patients will be randomized to receive standard of care and half~     will receive clinical management of 25[OH] Vit D levels.~   "
4624|NCT02996708|"~     The purpose of this study is to determine whether Teleconsultation would a)be effective and~     cost-effective by increasing the proportion of patients with Autism Spectrum Disorders~     having a correct follow-up, and less transportation, and b) get a high satisfaction from the~     parents and from the professionals~   "
5624|NCT02983552|"~     The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5~     days per week plus spectacle correction with spectacle correction only, for treatment of~     amblyopia in children 4 to <13 years of age.~   "
4612|NCT02996955|"~     Rationale: Low back pain is worldwide a common musculoskeletal condition with a high number~     of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a~     next episode could be prolonged by advising an active lifestyle. Advising regular physical~     activity is the mainstay in physical therapy treatment. This includes an appeal to patients~     to adhere to an activity advice. Patient adherence to an activity advice is poor. Many~     factors influence adherence. In this study an intervention consisting of treatment of~     illness perceptions with or without organizing social support to increase adherence to an~     activity advice will be investigated.~      Objective: The primary objective of this study is to investigate whether social support by a~     partner or friend and treatment of patients' illness perceptions influences the rate of~     adherence to an activity advice compared to treatment of patients' illness perceptions alone~     in patients suffering non-specific low back pain. Secondary objectives are; a) whether~     'treatment of illness perceptions' changes patients' maladaptive illness perceptions into~     realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or~     overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude~     and intention to physical activity influences patient's adherence to an activity advice.~      Study design: This study is a multi-centre randomized two-arm controlled clinical trial.~      Study population: Patients ≥18 years presenting with at least a second episode of~     non-specific low back pain.~      Intervention: Patients in the intervention and control group will be asked to perform a~     physical activity advice. During two physiotherapy treatment sessions treatment of illness~     perceptions is performed in both groups. In the intervention group organizing social support~     by a partner or friend is added.~      Main study parameters/endpoints: Twenty-five percent absolute improvement of walking and/or~     cycling according the NNGB in the intervention group is clinically relevant.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During four appointments several questionnaires have to be filled in and during~     two physiotherapy treatment sessions half an hour treatment of illness perceptions will be~     performed. Social support by a partner or friend will be organized during the same~     physiotherapy treatment sessions in the intervention group. During three separate weeks~     patients have to wear an activity monitor. Patients will be treated according to the Dutch~     Low Back Pain guideline; no adverse effects will be expected.~   "
4613|NCT02996942|"~     The KAPPa project has the aim to create an international database in which information about~     clinical features, therapeutic management, burden of illness and costs of severe and~     moderate haemophilia A patients from different countries and sites is collected. The aim of~     this project is to analyse the influence of such different characteristics on medical,~     psychosocial and economic outcomes in patients over the long-term.~   "
4614|NCT02996929|"~     The study's main purpose is to evaluate the safety and performance of the LeadExx LC System~     and its ability to safely extract leads.~      The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead~     extraction will be based upon the applicable Heart Rhythm Society guidelines or European~     Heart Rhythm Association (EHRA).~   "
4615|NCT02996916|"~     Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a~     major target of the damaging effects of hypertension. Hypertension has been recognized as~     the leading cause of dementia as well as the most important risk factor for stroke and~     vascular cognitive impairment. Although glucose is the principal cerebral energy source,~     impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.~   "
4616|NCT02996903|"~     The Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy~     IN Daily Practice in 2017 (PROTECTION-VI) study is a prospective registry and~     investigator-initiated initiative without third-party funding, which will collect and~     analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA)~     studies in current daily practice worldwide. Particularly, the study will assess the use of~     strategies for dose reduction during CCTA.~      A decade ago, the multicentre observational PROTECTION-I study has revealed that the~     dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x~     cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a~     variety of techniques have been developed and enhanced in order to reduce radiation exposure~     during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective~     radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of~     patients at scientific expert centers. However, it remains unclear, if such low-level~     radiation dose exposure may be achieved in clinical routine and if diagnostic image quality~     is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in~     today's clinical practice and the current use of dose-saving techniques, we designed the~     PROTECTION-VI study. Eventually, this study may contribute to further improving radiation~     dose exposure for patients undergoing CCTA.~   "
4617|NCT02996890|"~     Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in~     48 healthy volunteer subjects.~      After completion of screening procedures, the subjects are randomized to one of four~     treatment groups (different dosage strengths and placebo) All subjects will receive study~     treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with~     two vaccinations will receive a second treatment at day 28.~      Subjects will return on day 56 for the final visit.~   "
4618|NCT02996877|"~     The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort~     design to follow patients who have multivessel or left main coronary artery disease~     (surgical anatomy according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed~     ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be~     selected to participate in the registry from a national network of leading centers across~     the United States with recognized expertise in both complex PCI and coronary artery bypass~     surgery. We will invite leading cardiac centers, as defined by US News and World reports~     rankings for heart care. Additional sites may be added to meet the target enrollment goal.~   "
4619|NCT02996773|"~     The purpose of this study is to evaluate the safety and efficacy of substituting day +4~     cyclophosphamide with post-transplant bendamustine in myeloablative (MAC) or reduced~     intensity conditioning (RIC) haploidentical hematopoietic cell transplantation (HHCT) for~     advanced leukemia and lymphoma patients.~      The phase I component of the study is to evaluate the safety of completely substituting the~     second dose of post-transplant cyclophosphamide (PT-CY) given on day +4 with bendamustine~     (PT-BEN).~      The phase II component of the study will continue to evaluate the safety and efficacy of~     subjects who receive PT-CY on day +3 and PT-BEN on day +4.~      Approximately, a total of 32 subjects will be treated under this protocol. Approximately 12~     to 15 subjects will be used as control, subjects that receive no PT-BEN, for direct~     comparison.~   "
4620|NCT02996760|"~     Women in assisted reproduction treatment they receive own or donated embryos and presenting~     an endometrial development less than 5 mm despite having received treatment with estrogen~     therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level~     applications to improve endometrial thickness endometrial preparations for embryo transfer.~   "
4621|NCT02996747|"~     The purpose of this project is to verify possible clinical and radiological findings with~     regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In~     addition, this study presents the outcome of patients with enchondroma and low grade~     chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).~   "
4625|NCT02996695|"~     Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac~     safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in~     malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of~     PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides~     sterile protection against naturally-occurring malaria in malaria-experienced adults. The~     study population includes 62 healthy, malaria-experienced adults aged 18-45 years,~     inclusive, residing in Bougoula Hameau and surrounding villages, Mali.~   "
4626|NCT02996682|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or~     without ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated~     cirrhosis.~   "
4627|NCT02996669|"~     This is a multicenter longitudinal study that aims to identify, develop and validate a set~     of measures that can be used as stratification biomarkers and/or sensitive and reliable~     objective measures of social impairment in autism spectrum disorders (ASD) that could serve~     as markers of long term clinical outcome. The main study will include 275 individuals: 200~     ASD subjects between 6-11 years old, and 75 TD subjects roughly matched by age and sex to~     the ASD group.~   "
4628|NCT02996656|"~     INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at~     induction for all orthopaedic procedure with implantation of internal fixation device. With~     the increasing rate of identified P. acnes shoulder surgery infection despite the use of~     recommended skin preparation and preoperative prophylactic antibiotics, a question arises;~     Is Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective~     of this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic~     antibiotic for skin colonization with P. acnes in primary shoulder surgery~   "
4629|NCT02996643|"~     Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine~     associated with vertebral rotation. Brace treatment is the most commonly used non-surgical~     treatment. To obtain the best possible outcome, the best in-brace correction within the~     patient's accepted tolerance must be provided. However, in the existing clinical practice,~     the immediate in-brace correction cannot be measured during the design and fitting of the~     brace because the correction is determined using a radiograph. This study is to evaluate the~     effect of applying ultrasound to measure the stimulated in-brace correction during brace~     casting.~   "
4630|NCT02996630|"~     Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in~     100 newborns per year. Children with CHD are a known risk population for brain injury, with~     neurodevelopmental alterations shown over time in up to 50% of cases. No adequate~     description exists of the type of neurocognitive anomalies or risk factors associated with~     CHD, and consequently no prognostic markers that may allow identification of high-risk cases~     are available.~   "
4631|NCT02996617|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased~     plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study~     is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia~     following chemotherapy in patients with non-Hodgkin lymphoma.~   "
4632|NCT02996604|"~     He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints~     combination with synergistic effect for functional dyspepsia(FD). The investigators design~     the trial to identify the efficacy and explore the central integrated mechanism of~     puncturing at He-Mu-point combination on FD with functional magnetic resonance imaging~     (fMRI).~   "
4633|NCT02996591|"~     The purpose of this study is to determine if there is a difference in patient outcomes with~     general anesthesia versus spinal anesthesia when given in addition to popliteal and adductor~     canal nerve blocks for foot and ankle surgery. Popliteal and adductor canal nerve blocks are~     injections of local anesthetic agents near nerves in the back and front of the knee going to~     the foot and ankle that provide numbness during and after surgery. These peripheral nerve~     blocks offer good pain control and reduce the need for opioids (opioids are pain medications~     such as morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen~     and anesthesia gas through a tube which, along with additional intravenous medications,~     causes unconsciousness and unawareness of sensations during surgery. Spinal anesthesia~     involves an injection of local anesthetic in the lower back, which causes numbness below the~     waist. In addition to spinal anesthesia, a sedative is typically given intravenously to~     cause relaxation and sleepiness throughout surgery.~      General, spinal, and nerve block anesthesia are all routinely used for surgery at the~     Hospital for Special Surgery. General or spinal anesthesia is typically used in addition to~     peripheral nerve blocks during foot and ankle surgery to 1) allow the surgeons to use a~     thigh tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted~     movement. However, it is unclear whether general or spinal anesthesia provides better~     patient outcomes when given with peripheral nerve blocks. Some reports show that on its own,~     spinal anesthesia has advantages over general anesthesia in terms of side effects such as~     nausea and pain. However, these advantages may also be gained from combining peripheral~     nerve blocks with general anesthesia. Spinal anesthesia can be associated with headache and~     backache, although headache and backache can also happen after operations performed with~     general anesthesia. A previous study at the Hospital for Special Surgery showed low rates of~     nausea among patients who received nerve blocks with spinal anesthesia, and no nausea among~     patients who received a nerve block with general anesthesia. Therefore, the primary aim of~     this study is to determine if, as a treatment, either general or spinal anesthesia has~     advantages over the other treatment in terms of readiness for discharge, side effects, pain~     and patient satisfaction in an ambulatory foot and ankle population.~   "
4634|NCT02996578|"~     This project aims to investigate whether consumption of cocoa polyphenols has an impact on~     cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a~     result of an improvement in risk factors associated with cognitive decline in ageing.~   "
4635|NCT02996565|"~     This pragmatic trial will compare two team-based care models for managing hypertension, Best~     Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care~     system in Minnesota. Clinics in the study are randomized to offer one of the two treatment~     models to participants with uncontrolled hypertension.~      The investigators aim to determine a) whether one model is more effective than the other for~     lowering patient's blood pressure and b) which model patients prefer.~   "
4651|NCT02996357|"~     This study aims to identify patient characteristics associated with the development of~     Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).~      380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19~     possible risk factors will be collected at one point in time by the research team. Different~     sources and methods will be used to collect patient data: skin assessment, patient record,~     direct patient observation, routine blood samples.~   "
4672|NCT02996084|"~     The primary objective of this study is to determine the normative range of brain volume and~     brain volume change in healthy control (HC) participants whose age, race, and gender~     distribution is approximately matched to the age, race, and gender distribution of patients~     with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use~     the results of the primary endpoint to ensure consistency of brain volume measurements~     across MS PATHS centers.~   "
4636|NCT02996552|"~     The therapeutic strategy making in patients with ≤2 + functional tricuspid regurgitation~     (TR) is extremely controversial: some observational studies have suggested that perform the~     tricuspid annuloplasty in all patients undergoing mitral valve surgery have a dilated~     tricuspid ring, regardless of the degree of failure, may provide a clinical benefit, while~     in other observational studies such benefit has not been documented.~      The ESC Guidelines assign the class IIa recommendation in patients with tricuspid~     regurgitation≥ 2+ and dilated annulus, if surgery is concomitant to the repair or~     replacement of the mitral valve; this means that although the debate still ongoing,~     experimental evidence or expert opinion is in favor of the effectiveness and usefulness of~     the intervention in the patient with these clinical features.~      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in~     the early stage. The investigators enrolled patient with TR≤2+ and annular dilation~     undergoing mitral valve repair.~      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression by 2~     degrees compared to pre-operative, at discharge and 12 months after surgery, assessment by~     transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of~     combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at~     5 and 10 years after surgery.~      This will be an experimental superiority, prospective, spontaneous, single-center,~     randomized trial.~      Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1, to~     receive mitral repair only (Mitral-Only group) ore both mitral and tricuspid repair (M & T~     Repair group).~   "
4637|NCT02996539|"~     Several studies have investigated an association between cardiac autonomic neuropathy (CAN)~     and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved~     in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians~     and were limited to a small number of patients with type 1 diabetes mellitus, or had used a~     conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is~     consistent data showing that Asian diabetic populations, including the Chinese, have a~     higher risk of renal complications than Caucasians do.~      The present study investigated an association between heart rate variability (HRV)~     parameters and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM)~     patients, specifically through time and frequency domain analyses of HRV and urine albumin~     creatinine ratio (UACR) or estimated glomerular filtration rate (eGFR).~   "
4638|NCT02996526|"~     Population-based single centre, blinded, prospective cohort study of the impact of recurrent~     laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest~     is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and~     mortality outcomes will also be determined.~   "
4639|NCT02996513|"~     For assessing body retinol pools in preschool children, it is recommended that a blood~     sample is taken 14-21 days after isotope dosing. During this period, dietary intake of~     vitamin A should be controlled. Shortening of this period as has been validated for adults~     would reduce the burden for the children as well as improve research efficiency. The aim is~     to validate a 4-day protocol for assessing body retinol pools in preschool children by~     modelling data derived by retinol isotope dilution (RID) method. Venous blood samples will~     be collected of 60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A~     second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and~     28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional~     time points. Body retinol pools will be modelled, and the time point at which a parsimonious~     model applies (presumably at day 4) will be assessed.~   "
4640|NCT02996500|"~     This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and~     active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at~     Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to~     MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting~     conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered~     orally BID for 12 weeks in a blinded fashion.~   "
4641|NCT02996487|"~     The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in~     patients who are colonized with C. diff who are admitted to the hospital and need~     antibiotics for another infection.~   "
4642|NCT02996474|"~     Background:~      Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not~     treated. Treatment for AML that has not responded to treatment (refractory) or has returned~     after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy~     drug, combined with a less intense chemotherapy, may be able to help.~      Objective:~      To test if pembrolizumab, in combination with decitabine, is a possible treatment for people~     with relapsed or refractory AML.~      Eligibility:~      Adults 18 years of age and older with refractory AML or relapsed AML.~      Design:~      Participants will be first screened for eligibility.~      The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles.~     Participants may be in the study for up to 2 years if they are responding to the treatment.~      The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an~     outpatient.~      Participants will get pembrolizumab at the beginning of each cycle through an IV.~      Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other~     cycle.~      Participants will give blood samples.~      Participants will have bone marrow exams. A needle will be inserted into the hip to extract~     cells from the bone marrow.~      Some participants may give a sample of saliva from the inside of their cheek.~      Some participants may give a small skin sample. The top layer of the skin is removed.~      Some patients may require leukapheresis before starting treatment. This is a procedure to~     remove leukemia cells in the blood stream.~   "
4668|NCT02996136|"~     The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay~     intended for the qualitative detection of influenza A and influenza B viral nucleoprotein~     antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended~     to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This~     test is not intended for the detection of influenza C viruses. A negative test is~     presumptive and it is recommended these results be confirmed by cell culture of an FDA~     cleared molecular device. Negative results do not preclude influenza virus infection and~     should not be used as the sole basis for treatment or other management decisions.~   "
4669|NCT02996123|"~     measuring difference in biting force between (computer aided design/computer aided~     manufacturing) maxillary dentures and conventional ones.~   "
4643|NCT02996461|"~     STUDY DESIGN:~      This is a Phase I, randomized clinical study to evaluate the safety, tolerability, and~     immunogenicity of a 3 dose vaccination regimen with the Zika virus (ZIKVwt) DNA vaccine,~     VRC-ZKADNA090-00-VP. Subjects will be randomized to one of three groups: 1) full 4mg dose in~     one injection of the ZIKVwt DNA via intramuscular (IM) injection with needle and syringe 2)~     split dose (two 0.5 mL injections of one dose of ZIKVwt DNA) vaccine via intramuscular (IM)~     injection with needle and syringe 3) or IM injection with needle-free injection device,~     PharmaJet. The primary hypothesis is that the investigational ZIKVwt DNA vaccine will be~     safe and well tolerated in healthy adults. A secondary hypothesis is that the vaccine will~     elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety~     and tolerability of the vaccine in healthy adults. Secondary objectives are related to the~     immunogenicity of the vaccine and vaccination regimens.~      PRODUCT DESCRIPTION:~      The investigational VRC-ZKADNA090-00-VP vaccine was developed by the Vaccine Research Center~     (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of~     Health (NIH) and is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes~     the wild type precursor membrane M (prM) and envelope (E) proteins from the H/PF/2013 strain~     of ZIKV. ZIKVwt DNA vaccine is supplied in single dose vials at a concentration of 4 mg/mL.~      SUBJECTS:~      Healthy adults 18 to 50 years of age.~      STUDY PLAN:~      Forty-five subjects will be enrolled at the NIH Clinical Center site and randomized to 3~     Groups to receive 3 vaccinations, on Day 0, Week 4 and Week 8. The protocol requires about~     18 scheduled clinic visits and a telephone follow-up contact after each study product~     administration. Solicited reactogenicity will be evaluated using a 7-day diary card.~     Assessment of vaccine safety will include clinical observation and monitoring of~     hematological and chemical parameters at clinical visits throughout the study.~      VRC 320 STUDY SCHEMA:~        -  Group 1:~             -  Administration Method = Single Dose Needle and Syringe;~             -  Subjects = 15;~             -  Administration Schedule = Day 0 (ZIKVwt DNA(4mg as 1 injection of 1 mL)), Week 4~               (ZIKVwt DNA (4mg as 1 injection of 1 mL)), Week 8 (ZIKVwt DNA (4mg as 1 injection~               of 1 mL))~        -  Group 2:~             -  Administration Method = Split Dose Needle and Syringe;~             -  Subjects = 15;~             -  Administration Schedule = Day 0 (ZIKVwt DNA(4mg as 2 injections of 0.5 mL)), Week~               4 (ZIKVwt DNA (4mg as 2 injections of 0.5 mL)), Week 8 (ZIKVwt DNA (4mg as 2~               injections of 0.5 mL))~        -  Group 3:~             -  Administration Method = Split Dose PharmaJet;~             -  Subjects = 15;~             -  Administration Schedule = Day 0 (ZIKVwt DNA(4mg as 2 injections of 0.5 mL)), Week~               4 (ZIKVwt DNA (4mg as 2 injections of 0.5 mL)), Week 8 (ZIKVwt DNA (4mg as 2~               injections of 0.5 mL))~             -  Subjects Total = 45 (Up to 50 total enrollments are permitted if additional~               subjects are needed to assess safety or immunogenicity of the 4mg/mL dose.)~      STUDY DURATION:~      Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks~     following the first vaccine administration. Durability of immune responses will be evaluated~     at two long term follow-up visits, occurring at 18 and 24 months~   "
4644|NCT02996448|"~     Background:~      AD-HIES is a disease that weakens the immune system. It puts people at risk for infections,~     particularly Staph and Candida infections. Researchers want to test a vaccine that may help~     keep people from getting these infections, which would help people with AD-HIES.~      Objective:~      To test the new vaccine NDV-3A for protection against infection from the yeast Candida and~     the bacterium Staphylococcus aureus (Staph).~      Eligibility:~      Adults ages 18-55 who have AD-HIES~      Healthy volunteers ages 18-55~      Design:~      Participants will have 6-7 study visits over 6-7 months. They will also be contacted by~     phone in between some visits.~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests.~      Participants will have 2 baseline visits. They will have repeat the screening tests. They~     will have samples of saliva, stool, skin, mucus (oral, nasal, and/or vaginal) collected. Any~     eczema on their skin will be looked at.~      Participants will fill out symptom diary cards to record how they feel.~      Participants will have the NDV-3A vaccine injected into a muscle in the arm.~      Participants will return the next 2 days. They will have a physical exam. Blood will be~     collected.~      Participants will have 2 more follow-up visits at the NIH. They will have a physical exam.~     They will have blood, saliva, stool, skin, vaginal fluid, and/or mucus samples collected.~      Participants will be called once a month for 5 months after the vaccination. There is an~     optional visit about 6 weeks after the vaccination. Participants will provide a blood sample~     at this visit....~   "
4645|NCT02996435|"~     The primary purpose of this study is to evaluate the effectiveness of an intervention with a~     mobile adherence platform, compared to physician- or nurse-guided standard of care, to~     improve medication adherence to rivaroxaban in participants who have recently initiated~     treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an~     assessment of the proportion of days covered (PDC) of rivaroxaban treatment.~   "
4646|NCT02996422|"~     Most of the nation's serious chronic health challenges and causes of death, including~     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both~     poor diets and associated disease are disproportionately common in the Appalachian counties~     of eastern Kentucky, a region with stark health inequities, including elevated rates of~     obesity, overweight, and premature mortality. The purpose of this study is to evaluate a~     multi-component intervention developed through community-based participatory research~     methods for improving access to healthy foods and enhancing dietary intake in eastern~     Kentucky. The intervention components evaluated in this study consist of: 1) a school-based~     campaign to promote water consumption in middle and high schools and 2) a series of group~     cooking classes for adults.~   "
4647|NCT02996409|"~     Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual~     treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In~     most cases this gives satisfactory results, however there is a significant group of patients~     in which the exercise program is not sufficient. Prior to our study, three United Kingdom~     based studies have investigated the efficacy of High-Volume Image-Guided Injections~     (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results.~     However none of these studies had an adequate control group. This double-blind,~     placebo-controlled, randomized clinical trial will investigate the value of a High-Volume~     Image-Guided Injection in chronic midportion Achilles tendinopathy.~   "
4648|NCT02996396|"~     Multicenter, single arm, open label, registry study with consecutive, eligible patient~     enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System~     (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as~     per institutional standard of care thereafter through to 5 years (total follow-up~     commitment)~   "
4649|NCT02996383|"~     In England each year over 70,000 people fracture their hip. Most of these patients are~     elderly females with the fracture occurring after a simple trip or stumble. Approximately~     half of these fractures are classified from their relationship to the hip joint capsule as~     intracapsular. These fractures are subdivided into those that are displaced and those that~     are undisplaced. The majority of displaced fractures are treated with a replacement~     arthroplasty. Current treatment for the undisplaced fractures is generally by internal~     fixation of the fracture using screws and a plate, although some centres prefer replacement~     arthroplasty.~      A recent randomised study on patients from Norway with undisplaced intracapsular fractures~     treated with either internal fixation or arthroplasty has just reported reduced~     complications and re-operations for those patients treated with an arthroplasty. In addition~     functional results were marginally better for those patients treated with an arthroplasty.~     Current practice in the UK is generally to treat these fractures by internal fixation. This~     study aims to see if replacement arthroplasty can indeed lead to the advantages suggested~     from the Norwegian study.~      Patients who satisfy the inclusion criteria and are willing to participate will be~     randomised to receive either reduction and internal fixation of the fracture with a screw~     and plate device or alternatively replacement of their femoral head with an artificial hip~     replacement (hemiarthroplasty). After surgery patients will receive the same treatment as~     normal and be discharge home when able, with follow-up review in the hip fracture clinic.~     Subsequent follow-up for the research project is by phone calls from a research nurse who is~     blinded to the type of treatment that the patient has received. There will be no additional~     investigations or out-patient follow-up visits for these patients in comparison to normal~     treatment protocols. Results of the study will ultimately be published in a medical journal.~   "
4650|NCT02996370|"~     Regenerating a predictable inter-implant papilla is the most complex and challenging aspect~     of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision~     technique and conventional midcrestal incision technique for interimplant papilla~     reconstruction in a 6 month clinical trial.~   "
4652|NCT02996344|"~     This randomized control study responds to the need for effective suicide prevention~     education/training that is grounded in adult learning theory and advances in education, in~     the context of a changing health care landscape where primary care providers are likely to~     encounter suicidal individuals. The study will test the effectiveness of suicide prevention~     education for providers-in-training by comparing two conditions: 1) A Control learning~     group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered~     online via brief videos, and 2) An Experimental learning group: includes didactics plus two~     standardized patient (SP) interactions. One Experimental learning group SP interaction will~     be in person and the other will be conducted remotely using a secure webcam service (OoVoo).~     All SP interactions will be recorded. Both groups will be compared in terms of their suicide~     prevention skills using an SP 'test case' at 6-month follow up. The primary research~     question is to learn about the impact of practice (though SP simulation) over and above~     didactics alone.~   "
4653|NCT02996331|"~     The purpose of this study is to determine whether repositioning frequency can be extended~     for nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer~     (PrU) development. The investigators will also determine how changes in medical severity~     interact with changes in risk level and repositioning schedule to predict PrU development.~     This study will advance knowledge about repositioning frequency and clinically assessed PrU~     risk-level in relation to medical severity. Outcomes of this research will contribute to~     future guidelines for more precise preventive nursing practices and refinement of PrU~     prevention guidelines.~   "
4654|NCT02996318|"~     The aim of the study is to investigate the non-inferiority of the new sirolimus-coated~     balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,~     safety and efficacy in coronary DES in-stent restenosis.~   "
4655|NCT02996305|"~     The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)~     in adult subjects with Angelman syndrome. In addition, several exploratory efficacy outcome~     measures will be investigated.~   "
4656|NCT02996292|"~     This experimental study will evaluate the effect of active and passive self-ligating~     brackets in treatment of crowding, compared with the control group of conventional brackets~     in class I malocclusion without extraction.~      The study sample will consist of 66 patients with 3-6mm crowding. The sample will be~     allocated randomly into two experimental groups, in addition to a control group.~      The brackets will be applied using indirect bonding method for all patients. The~     dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using~     CBCT radiographs; pre and post- treatment changes for each group will be evaluated~     individually.~   "
4657|NCT02996279|"~     Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome~     (FIRS) and increased levels of proinflammatory molecules.~   "
4658|NCT02996266|"~     This study will assess the impact of fever prevention on fever burden and short- and~     long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo~     fever prevention using a targeted temperature management system and half of the subjects~     will be treated for fever should it develop.~   "
4659|NCT02996253|"~     The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon~     ruptures has demonstrated good functional outcome, but an extensive surgical field at a~     vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic~     FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are~     investigated, wound/soft tissue complications registered.~   "
4660|NCT02996240|"~     Assess the impact of dietary omega 3 free fatty acids breast cancer patients.~   "
4661|NCT02996227|"~     Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous~     Epidural Analgesia With Bupivacaine~   "
4662|NCT02996214|"~     The purpose of this study is to investigate the efficacy and the safety of paclitaxel~     liposome injection and carboplatin compared with gemcitabine and carboplatin as first-line~     therapy in advanced squamous cell carcinoma of lung.~   "
4663|NCT02996201|"~     The aim of this study is to determine whether the use of breast cancer patients' own~     electronic reporting of side effects to chemotherapy in a treatment setting has an impact on~     the handling of side effects and on the number of hospitalizations, febrile neutropenia and~     dose adjustments. We are using the Patient-Reported Outcomes version of the Common~     Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side~     effects.~   "
4664|NCT02996188|"~     The aim of our study was to evaluate hemodynamic changes during routine paracentesis in~     tense ascites using non-invasive inert gas rebreathing.~   "
4665|NCT02996175|"~     The investigators long-term goal is to improve outcomes for children with Down syndrome (DS)~     and their caregivers. Towards that goal, the investigators propose a randomized clinical~     trial of a behavioral sleep treatment designed specifically for children with DS,~     documenting the impact not only on sleep, but also on the child's daytime inhibitory control~     and behavior problems, and the caregiver's sleep and stress levels. The investigators will~     randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral~     sleep treatment (BST; targeting sleep education, behavioral principles and visual supports)~     or a general-education control condition (CON). The BST will cater to the unique needs of~     children with DS, adapting an intervention that successfully treats behavioral sleep~     disturbances in children with autism1. Pre- and post-intervention, children will undergo~     comprehensive assessments of cognitive, behavioral, and adaptive functioning involving~     direct testing and input from parents and teachers. Child and parent sleep will be monitored~     via actigraphy and parent-completed sleep diaries, and parents will report on their stress~     levels and mood.~   "
4666|NCT02996162|"~     This is a prospective, longitudinal observational study to provide data regarding the~     natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using~     both available blood pCO2 and measured capnography, as well as relate the degree and trend~     of hypercapnia to later respiratory outcomes.~   "
4667|NCT02996149|"~     Endoscopic lung volume reduction coil treatment is a treatment option for selected patients~     with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic~     respiratory failure. In this observational study the safety and efficacy of endoscopic lung~     volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is~     evaluated.~   "
4673|NCT02996071|"~     Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one~     of surgical methods and became popular in recent years. Weight loss rates after bariatric~     surgery differs among patients. The exact reason of this difference stays unclear. age,~     nationality, difference between body composition and type of surgery may be in concern.~     waist to height ratio has become popular recent years as an indicator of cardiomethabolic~     status. in this study, investigation of the effect of waist to height ratio differences of~     patients on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.~   "
4674|NCT02996058|"~     Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic~     properties. Despite off-label administration, dexmedetomidine has found a niche in~     critically ill mechanically ventilated neonates and infants because of its minimal effects~     on respiratory function at sedative doses, facilitating early extubation and fast-track~     postoperative care.~   "
4675|NCT02996045|"~     The goal of the study is to determine whether clinical decision support (CDS) for radiology~     affects the number, type, or appropriateness of targeted high-cost radiology imaging orders~     (i.e. magnetic resonance (MR), computed tomography (CT), nuclear medicine (NM) and Positron~     Emission Tomography (PET) scans). The CDS will be delivered to physicians in the Aurora~     Health Care system. It will be delivered in Epic, an industry-standard electronic medical~     record software, through ACR Select, which is a leading decision support tool based on the~     American College of Radiology (ACR) Appropriateness Criteria (see~     http://www.acr.org/Quality-Safety/Appropriateness-Criteria). The ACR Select tool rates~     imaging orders on a scale of 1-9 with 1-3 labelled as 'usually not appropriate', 4-6 'May be~     appropriate', and 7-9 'usually appropriate'.~   "
4676|NCT02996032|"~     This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines)~     can predict patients at higher risk of readmission within 30 days of hospital discharge for~     decompensated heart failure.~   "
4677|NCT02996019|"~     This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to~     compare the PK of etrolizumab administered SC by AI (test device) or a PFS-NSD (reference~     device) in healthy participants. The study will comprise a pilot cohort to estimate the~     geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and~     area under the concentration-time curve (AUC) to confirm or determine the sample size for~     the pivotal cohort. The pivotal cohort will demonstrate exposure comparability of Cmax, AUC~     from hour 0 to the last measurable concentration (AUClast), and AUC extrapolated to infinity~     (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by an~     AI or PFS-NSD.~   "
4678|NCT02996006|"~     This observational study introduced an new advanced bleeding control strategy during complex~     liver resection.This newly described stepwise vascular control technique was efficacious~     and feasible to control intra-operative bleeding in complex hepatectomy involving second~     hepatic hilum and retro-hepatic inferior vena cava.~   "
4679|NCT02995993|"~     Six patients with Fabry disease will be recruited. Patients will receive a single dose of~     0.2 mg/kg recombinant human alpha-galactosidase A produced in moss (moss-aGal) as~     intravenous infusion. Patients will be hospitalized during the infusion and for at least 24~     hours after the end of the infusion. Treatment will be administered sequentially: if a~     patient shows no safety concerns on the treatment day, treatment of the next patient will~     commence on the following day.~   "
4680|NCT02995980|"~     This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital~     mammography to detect breast cancer in patients with increased breast density (BI-RADS~     category c or d). Eligible patients will be invited to have full-field digital mammography~     and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the~     imaging methods for the detection of breast cancer.~   "
4681|NCT02995967|"~     The specific aim of this trial is to determine if hydrodistention at the time of~     intradetrusor injection of botulinum toxin A has additional benefit in patients with~     refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection~     of botulinum toxin A alone.~      Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5~     minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~     (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone~     (botulinum toxin A alone group).~      The primary aim will be subjective improvement measured as change from baseline at 12 weeks~     using the OAB-q bother subscale.~   "
4682|NCT02995954|"~     The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased~     patients compliance and adherence to therapy. At the moment, however, there are no data~     suggesting the better control of once-daily fixed (Fixed) over free doses in separate~     administrations combination therapy in hypertensives.~      In a population of 39 consecutive outpatient patients referred to the departmental~     Hypertension clinic of the University Hospital of Salerno Medical School with the first~     diagnosis of arterial hypertension, the investigators tested the hypothesis that the Fixed~     achieve a better control of blood pressure than the Free combination. Patients were~     randomized to either strategy and after 3 months patients underwent a clinical assessment to~     evaluate the antihypertensive effect.~   "
4683|NCT02995941|"~     The purpose of this study is to examine the reliability and use of the shoulder symptom~     irritability classification system for the purposes of determining an appropriate treatment~     intensity to better help people with shoulder pain.~   "
4684|NCT02995928|"~     Decompressive craniectomy has been reported for the treatment of patients with aneurysmal~     subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet~     been undertaken to confirm its effect.The purpose of the study is to determine whether~     decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will~     improve clinical outcomes of poor-grade aSAH patients.~   "
4685|NCT02995915|"~     Alcohol misuse and smoking constitute two of the three leading preventable causes of death~     in the United States. The purpose of this research study is to develop an intervention~     designed to help people stop drinking alcohol and stop smoking at the same time.~   "
4686|NCT02995902|"~     The purpose of the study is to determine the value of FLT-PET early after initiated~     chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the~     brain should be performed routinely in these patients.~   "
4687|NCT02995889|"~     This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in~     patients with irradiated lung cancer in comparison with FDG-PET/CT.~   "
4688|NCT02995876|"~     When missing tooth structure or teeth are replaced, minimal biologic risk should be involved~     to re-establish function and esthetics. The increased use of the adhesive technique and~     preservation of dental tissues have greatly impacted conservative tooth preparation design.~     The development use of zirconia technology and all-ceramic systems has opened the potential~     for fabrication inlays zirconia bridges with durability and good aesthetics.~      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a~     Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive~     approach in the replacement of a single missing tooth.~   "
4689|NCT02995863|"~     This research presents a randomized clinical trial which analyzes the efficacy of a rigid~     rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot~     patients. The hypothesis of the research is the use of a rigid rocker sole reduces the~     recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.~   "
4690|NCT02995850|"~     This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy~     and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic~     intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy~     combination in gastric cancer with peritoneal metastasis~   "
4691|NCT02995837|"~     Obstructive sleep apnea syndrome (OSAS) causes hypoxemia and hypercapnia, which may impair~     cerebral blood flow and cause deficits in behavior. This is a case-control study designed to~     investigate cerebral blood flow and neurocognitive function in children with OSAS when~     compared to these findings from normal children. The study hypothesis is that children with~     OSAS have an impaired cerebral blood flow during wakefulness and sleep compared to normal~     controls, and that the degree of this impairment correlates with neurocognitive function.~   "
4692|NCT02995824|"~     This is a retrospective observational multicenter cohort study based on 271 consecutive~     HIV-HCV coinfected patients who underwent liver transplantation (LT) between 2002 and 2012~     in 23 centers from Spain and who were prospectively followed until January 2016. The main~     objective of this study is to analyze the effectiveness and safety of 2 nucleoside reverse~     transcriptase inhibitors (NRTIs) plus Raltegravir (RAL)- based antiretroviral therapy (ART)~     compared to other antiretroviral regimens in liver transplant (LT) HIV-HCV co-infected~     recipients. In addition, the investigators want to know the rejection rates in patients~     taking RAL-based ART in comparison with other ART-regimens and to know the efficacy and~     safety of direct antiviral agents (DAAs) against HCV in HIV-infected liver transplant~     recipients taking RAL-based ART.~   "
4693|NCT02995811|"~     This study will identify the changes in different muscles of patients receiving~     Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to~     Intensive Care Unit (ICU). The information will help guide development of treatments such as~     exercise that may help to reduce the amount of muscle wasting that can occur during critical~     illness.~   "
4694|NCT02995798|"~     Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the~     cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April~     2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year~     (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any~     destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral~     mass. Patients were divided into three groups according to femoral neck BMD (Group A,~     T-score ≥-1; Group B, -2.5<T-score<-1.0; Group C, T-score≤-2.5). Group A had normal BMD~     patients, Group B had lower normal patients including osteopenic patients and Group C~     presented osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral~     canal (cHU, the medial wall of the lateral mass), the posterior wall of transverse foramen~     (fHU), the medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were~     measured on the axial CT images in clinical images.~   "
4695|NCT02995785|"~     [Background and Objective]First-aid skill training plays an important role in the education~     of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,~     Oermann, Odom-Maryon, & Ha, 2010). Simulation-based workshops,or training, as the most~     common enhancing skills.(Topping et al., 2015) .This study was designed to assist nurses~     enhancing the clinical ability and safety the patients in the first aid-related skills and~     knowledge. The purpose of this study is to compare the two groups of(1) first aid knowledge~     online test. (2) first aid skills test.【Methods】This study is a general ward nurses first~     aid technical examination, pre-test and post-test, the random control trial. Review by the~     hospital ethics committee and execution date on105/12/12-107/03/08, a total of 92 cases,~     obtained consent of all cases, then the case will be test in our hospital clinical skills~     center. Subject condition: general ward nurse (minimum age> 20 years),exclusion conditions:~     intensive care unit nurses, emergency department nurses. Study Procedure: Subjects who~     obtained the informed consent were randomly assigned to the first aid skill simulation~     training group (FAST) or the traditional group (T) by using a computer generated number.~     Randomization envelopes were opened and randomization performed by the study nurse after~     informed consent was obtained. Each group consisted of 46 subjects. All the subjects were~     pre-test first aid knowledge online test, followed were pre-test first aid skills test at~     the Clinical Skills Center.After pre-test,the experimental group are give the first aid~     skill simulation training with debriefing(75-min) and online lecture(15-min).While the~     traditional group only give online lecture(15-min). Two weeks later, the post-test include~     online test and skills test for two groups. After all the data were collected by the~     researchers who unknown the groups, the names of the cases were removed and the scores of~     the two groups were compared before and after.The test Based on 2015 AHA Guidelines for CPR~     & ECC (2015 Adult Basic Life Support and Cardiopulmonary Resuscitation Quality &~     2015American Heart Association and 2015).The data will be archived in SPSS20.0 statistical~     package software. Statistical methods such as T-test and Anova variance analysis are used to~     analyze the data【Expected Result】: The knowledge and skills in the experimental group were~     better than the traditional group, and the first-aid simulation skill training was helpful~     for the clinical emergency situations.~   "
4696|NCT02995772|"~     This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated~     with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy~     (NACT)~   "
4697|NCT02995759|"~     Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is~     crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the~     creation of a seizure action plan, an intervention aimed to guide daily medication use,~     outline pre-hospital seizure first aid and rescue medication use, and direct emergency~     personnel in patients' individualized SE medication algorithm, with implementation through~     the electronic medical record. We hypothesize that the seizure action plan will promote~     daily medication adherence, increase use of home rescue mediation, and improve timeliness of~     AED (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in~     episodes of status epilepticus.~   "
4698|NCT02995746|"~     This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on~     central macular thickness and visual acuity in those patients with persistent macular edema~     after pars plana vitrectomy for epiretinal membrane.~   "
4699|NCT02995733|"~     Asthma imposes a significant burden in the US in terms of morbidity, costs to society,~     individual suffering, loss of productivity and mortality. African Americans (AA) and~     Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national~     guidelines for asthma treatment, the gap between these groups and whites has been stable or~     widening. The need for pragmatic research to address the continuing burden is widely~     recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms.~     Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to~     prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis,~     in all but the mildest asthma. However, adherence by patients and implementation of~     evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests~     that it is difficult to improve adherence to the current recommendations without complex and~     resource-intensive interventions. Studies have examined symptom-activated use of ICS~     triggered by use of a reliever medication. The Investigators call this approach PARTICS -~     Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world~     studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared~     with usual care, while reducing ICS use by half or more. These studies have been performed~     in pre-selected populations, which represent less than 5% of asthma patients. The previous~     studies have been done with repeated education and adherence checks in both the intervention~     and control arms.~      We have consulted with AA and H/L patients, health care providers, leaders of professional~     societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical~     manufacturers. All groups have indicated that asthma decision making would be changed if we~     demonstrated that implementing PARTICS improves important asthma outcomes such as reducing~     exacerbations. The Investigators have designed a study with the stakeholders to determine~     whether PARTICS can improve outcomes that are important to patients when superimposed on a~     background provider-educated standard of care through the Asthma IQ system. The~     Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma~     Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS~     can reduce asthma morbidity in AA and H/L. The primary outcome will be asthma exacerbations.~     The secondary outcomes will include additional outcomes important to patients (i.e. days~     lost from work or school, asthma control, & asthma quality of life). The study has broad~     input and involvement from multiple stakeholder groups in study design, implementation, and~     commitments for dissemination. AA and H/L patients and their advocates have been involved~     and will continue to play a central role in all phases of the study.~   "
4700|NCT02995720|"~     An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare~     the pharmacokinetics and safety between a fixed dose combination of~     Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of~     Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.~   "
4701|NCT02995707|"~     This is an exploratory experiment, aims to explore the effective and safety of thalidomide~     in the treatment of NTDT to improve the hemoglobin level, improve the quality of life,~     reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30~     patients will be enrolled, including type α 5~13 cases, type β 10~17 cases.~   "
4702|NCT02995694|"~     The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol~     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol~     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7~     day treatment.~   "
4703|NCT02995681|"~     People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their~     balance and a high incidence of falls compared to those of a similar age. Pulmonary~     rehabilitation is recommended for people with COPD, however, these training programs do not~     typically include balance training or fall prevention strategies. In this study, patients~     with COPD who report problems with their balance or have had a fall in the last two years~     will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or~     control group (standard pulmonary rehabilitation). We will record the number of falls using~     monthly diaries and evaluate patient's balance, strength, confidence and quality of life.~   "
4704|NCT02995668|"~     Knee osteoarthritis is one of the most common pathologies in old people, and the leading~     cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility,~     functional impairment and proprioceptive deficit. When conservative treatments fail to~     control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly~     because of its efficacy on pain relief. In recent decades, this surgical procedure has been~     soared, and it has also aroused the interest of researches about the patients' outcomes~     after surgery.~      Despite the TKR results in good reported outcomes, after surgery patients may manifest~     persistent pain and problems affecting to their functionality, stability, walking speed,~     proprioception, motor control, risk of falling and therefore to their quality of life. In~     more than a third of the cases, those deficiencies may be extended after surgery from six~     months to one year, when subjects use to achieve the plateau functional values.~      Traditional rehabilitation programs have been usually focused on improving muscle strength~     of the lower limbs as well as the functionality with specific exercises to achieve this~     purpose, and to a lesser extent on balance and proprioception exercises. Evidence supports~     this approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one~     of the most important factors for a complete rehabilitation, since benefits of~     proprioceptive and balance trainings may range from better stability and motor control,~     improvements in both static and dynamic balance and enhanced functionality. Indeed, recent~     studies have shown that the combination of traditional functional rehabilitation together~     with balance training may help to restore functional deficits to a larger extent than usual~     therapy, and based on a systematic review published (Moutzori, 2015) and in our previous~     works (Roig, 2016), sensori-motor training is an acceptable adjust to usual physiotherapy~     care .~      Looking into the effect of preoperative trainings or education before TKR surgery, it is~     aimed at improving the physical function, but also managing the expectations of the surgery~     for a better recovery. There is from low to moderate evidence about the effects of TKR~     pre-interventional training programs, and some authors have argued that the effects are too~     small to be consider clinically relevant.~      In general, the preoperative program is usually focused on functional and strengthening~     exercises. Despite of proprioception is used in the clinical practice for the prevention and~     recovery of many orthopedics injuries, the amount of evidence about the effects of~     proprioceptive training programs for knee and hip replacement is not large, few works~     compares pre-habilitation and post-rehabilitation programs, and there is not systematically~     reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional~     training programs.~      In this framework, this aimed at evaluating the effects of specific-task oriented~     proprioceptive and balance training programs when conducted by patients undergoing TKR~     before and after surgery, and will compare these effects to the outcomes achieved with~     traditional strength-functional programs, as well as to no specific prehabilitation~     training.~   "
4705|NCT02995655|"~     The investigators hypothesize that CX-01 will disrupt the bone marrow microenvironment and~     increase the cytotoxic effects of azacitidine on myelodysplastic syndrome (MDS) and acute~     myeloid leukemia (AML) hematopoietic stem cells by disrupting the High-mobility group box~     protein 1 (HMGB1) interaction with toll-like receptor 4 (TLR4) and receptors for advanced~     glycation end products (RAGE), the CXC chemokine CXCL12/chemokine receptor 4 (CXCR4) axis,~     and by disrupting other leukocyte and vascular adhesion molecules. In addition, CX-01 may~     also help promote count recovery after treatment given its affinity for platelet factor-4~     (PF4).~      The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based~     upon the dual requirements to have sufficient drug administered to have potential activity~     but without clinically significant anticoagulation. The study dose chosen (4 mg/kg bolus~     followed by 0.25 mg/kg/hour) fulfills both of these criteria. In addition, this dose is~     expected to result in serum levels of CX-01 which are significantly higher than the IC90~     identified in preclinical studies for inhibition of HMGB1-RAGE, toll-like receptor 2 (TLR2)~     and TLR4 interaction. Therefore, the chosen dose represents a rational balance between~     effective dosing and safety in thrombocytopenic patients with MDS and AML. This dose was~     previously established to be safe and tolerable when combined with cytarabine and idarubicin~     in patients with AML.~   "
4706|NCT02995642|"~     Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases.~     Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and~     AAAs.~      The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those~     diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and~     macrophages.~   "
4707|NCT02995629|"~     Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser~     to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat~     patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required~     to achieve gray-white retinal burns and duration of treatment.~   "
4708|NCT02995616|"~     The aim of this study will be to investigate the energy consumption, cardiorespiratory load~     and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted~     gait training (RAGT) session and to compare the exercise intensity with aerobic training~     recommendations.~      The second aim is to investigate the effect of different levels of guidance force on the~     energy consumption, cardiorespiratory load and perceived exertion.~   "
4709|NCT02994784|"~     This is a single arm, open label study designed to evaluate the safety and efficacy of~     propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment~     will be comprised of propylene glycol-free melphalan hydrochloride administered~     intravenously at a dose of 70-100 mg/m2/day on Days -3 and -2 as conditioning prior to~     autologous stem cell transplantation.~   "
4710|NCT02994771|"~     Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast~     Cancer.~      Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin®~     in patients with secondary lymphedema associated with the treatment of breast cancer.~   "
4711|NCT02994758|"~     The purpose of the study is to evaluate whether state-of-the-art technologies such and next~     generation sequencing and drug sensitivity and resistance testing of patient derived tumour~     tissue can facilitate research translation and improve outcome of urologic cancers.~   "
4712|NCT02994745|"~     The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of~     Fimasartan and Atorvastatin in Healthy Male volunteers.~   "
4713|NCT02994732|"~     The primary objective of this study is to characterize the metabolic disposition,~     pharmacokinetics (PK), and routes of elimination of [14C]‑labeled BVD‑523 after~     administration of a single, oral dose to healthy male subjects.~      The secondary objective of this study is to evaluate the safety and tolerability of a single~     oral dose of [14C]‑labeled BVD‑523 in healthy male subjects.~   "
4714|NCT02994719|"~     The purpose of this study is to investigate whether speed-dependent measures of gait can be~     identified in patients with neurological conditions that affect gait, particularly in~     subjects with parkinsonian disorders.~   "
4735|NCT02995330|"~     Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line~     treatment with either androgen deprivation therapy alone or androgen deprivation therapy~     plus docetaxel who have an identified related female donor (mother sister, daughter, second~     degree relative such as granddaughter or niece) will undergo bone marrow transplantation~     followed by post-transplant Cytoxan (PT/Cy) and testosterone.~   "
4736|NCT02995317|"~     The purpose of this study is to investigate if the level of physical activity, selected~     physical and psychological risk factors can predict risk of falling in older (≥65) community~     dwellers.~   "
4715|NCT02994706|"~     Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing~     recurrent chest infections and premature death due to lung failure. When patients develop~     chest infections their symptoms usually slowly worsen over the course of several days to~     weeks. Due to this gradual onset, patients often seek medical attention several days or~     weeks after symptoms start to worsen. The Investigators believe that if they were able to~     monitor patients more closely they could diagnose and treat chest infections earlier and~     consequently improve health outcomes.~      The HOMECF study aims to investigate whether home monitoring is beneficial for adults with~     CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive~     routine clinical care for 12 months. Subjects receiving home monitoring will measure their~     lung function and symptoms twice weekly and this data will be transmitted to the medical~     team by means of a modified mobile phone.~      the Investigators hypothesize that home monitoring will allow them to diagnose chest~     infections at an earlier stage and reduce hospital inpatient days. They will also assess the~     subjects' experience of receiving home monitoring, the impact on body weight and lung~     function and and conduct a full health economic analysis to assess value for money. They~     will also ask subjects to collect a urine sample once weekly to allow us to measure urinary~     levels of inflammatory markers.~      Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research~     team are well placed to carry out the study because it is a large regional adult CF centre~     with an excellent record of conducting clinical research.~   "
4716|NCT02995590|"~     Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic~     Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively~     measuring physiological lung deformation on a regional basis. This unique imaging technique~     holds great promise for assessing, validating, and improving the use of Deformable image~     Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas~     tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms~     for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this~     application is to optimize the hyperpolarized helium tagging MRI technology and establish~     its usefulness for DIR assessment.~      Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D)~     hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung~     deformation between inhalation and exhalation. Our second objective is to develop~     physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy~     subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be~     used to evaluate a range different DIR algorithms, by comparing the errors between the~     DIR-derived deformation vector fields and the ground truth represented in the digital~     phantom. Successful completion of these aims will yield a novel methodology for DIR~     assessment in the lung for radiotherapy.~   "
4717|NCT02995577|"~     The purpose of this study is to investigates serum and stool biomarkers as predictors for~     post-operative feeding intolerance in infant patients with complex congenital heart defects~     who undergo single ventricle staged palliation surgery.~   "
4718|NCT02995564|"~     This study is investigating the development of a social skills training program for adults~     with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal~     Investigator for this study is Dr. Michael Murray, the director of the Autism Studies~     Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a~     social skills training program to address and enhance the social skills of adults with~     Asperger's Syndrome and high-functioning autism.~   "
4719|NCT02995551|"~     There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can~     be caused by either a smaller or larger trauma or be a degenerative age-related tear.~     Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality~     studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40~     years or younger) in comparison to non-surgical treatments.~      The purpose of this study is to determine if a strategy of early arthroscopic meniscal~     surgery (repair or resection) is superior to a strategy of initial individualized supervised~     exercise therapy including patient education with the option of later surgery if needed in~     improving pain, function and quality of life in young patients (18-40 years) with meniscal~     tears.~      The hypothesis is that patients treated with early arthroscopic meniscal surgery will~     improve more than patients treated with exercise and education.~   "
4720|NCT02995538|"~     The objective of this project is to develop a Neurogenetics patient database and bio~     repository - which includes clinical information regarding history, physical examination,~     laboratory testing including genetic testing (NextGen sequencing including whole exome and~     whole genome sequencing, SNParray, etc.), neuroradiology studies, neurophysiology studies -~     all ordered as clinically deemed appropriate, natural history from clinical longitudinal~     follow-up and to use de-identified information from this registry/ repository, when~     appropriate for clinical and translational research.~   "
4721|NCT02995525|"~     The aim of this epidemiologic prospective study is to determine the prevalence of CPSP~     defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a~     10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.~      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant~     thoracic surgery in children aged 6 to 18 years.~      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of~     neuropathic syndrome and the predictive risk factors.~   "
4722|NCT02995512|"~     The aim of this study is to determine the immuno-modulatory mechanistic effects of~     colchicine in patients with myocardial infarction (MI). Investigators hypothesize that~     colchicine exerts its anti-inflammatory properties by switching the metabolism of~     neutrophils, thereby reducing the expression of adhesion molecules responsible for their~     recruitment in MI.~   "
4723|NCT02995499|"~     The ASA-PS classification, a subjective classification system of the patients' preoperative~     health status, contains a certain problem concerning its interrater reliability. A~     comparison between anesthesiologic and surgical assessment of the preoperative patient~     condition has not yet been extensively investigated. The aim of this study is to examine the~     latter in a prospective, monocentric, observational study.~   "
4869|NCT02993497|"~     In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a~     respiratory volume monitor to determine the accuracy of the ventilation rate of the infra~     red camera by measuring the respiratory rate, ventilation volume, and ventilation volume~     with respiratory volume monitor.~   "
4724|NCT02995486|"~     A randomized, control trial will be conducted to evaluate the effects of a post-discharge~     falls prevention program in patients with neurological diseases and disorders. The objective~     of this study is to evaluate if implementing a falls prevention program is effective in~     reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance~     in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center~     will be randomized on the day of discharge to receive an exercise falls prevention program,~     delivered by Baptist Health physical therapists, or an educational pamphlet on falls~     prevention. Baseline and follow up assessments for gait, balance, and strength will be~     completed at regular intervals to examine effects of the exercise program. In addition,~     participants will be surveyed to find out about recent falls and hospitalizations. This is a~     minimal risk study such that the assessments involve conditions in which subjects likely~     encounter on a daily basis. The risks of the exercise intervention also are no more than one~     might expect from a community exercise program. Potential benefits include reduced~     hospitalizations and/or emergency visits related to falls in the intervention group,~     increased activity levels and improved falls efficacy in the intervention group, and~     increased system capacity at Baptist Health to deliver a falls prevention program.~   "
4725|NCT02995473|"~     This study is to evaluate the efficacy and safety of topical application of NP000888~     ointment compared to vehicle in plaque and fingernail psoriasis subjects.~      Duration of administration: 24 weeks~   "
4726|NCT02995460|"~     Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced~     physical function. Patients have a higher risk of cardiovascular disease and a higher body~     mass index.~      A pilot study in patients with rheumatoid arthritis has shown positive effect on~     inflammation after 12 weeks of high-intensity interval training.~      The primary aim of this study is to determine whether high-intensity interval training~     affects the disease activity in psoriatic arthritis. This intervention is believed to result~     in benefits in terms of inflammation, body composition and risk factors for cardiovascular~     disease.~   "
4727|NCT02995447|"~     The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison~     between scalp and intracerebral electrodes~   "
4728|NCT02995434|"~     This study seeks to explore the efficacy of virtual reality (VR) as a practical adjunctive~     therapeutic intervention in the self management of the chronic pain associated with cancer~     survival. A comparative controlled interventional trial and qualitative~     interpretative-descriptive exploration will be undertaken with 100 Cancer survivors who are~     experiencing chronic pain. Participants will be randomly assigned to either a VR therapy~     group or a control group (50 subjects in each). They will undertake either a series of VR~     interventions, or non--active (no- VR) control sessions in their own homes over a period of~     a month. The intervention will be used daily for a month to enable customization to the~     therapy and record data over a long enough period of time to account for any individual~     short--term changes in pain. The VR sessions will consist of using a VR head mounted display~     (HMD) and computer to explore an interactive VR environment. The control group will be~     exposed to a selection of environmental videos designed to provide passive relaxing~     audio--visual experiences on a high- definition 2D TV screen. Pre and post pain test scores~     will be recorded using standardized tools. At the end of the study, ten of the subjects who~     demonstrated the most improvement in their pain using VR will be selected and invited to~     explore for any measurable changes in neurological activity using pre and post exposure MRI~     studies.~   "
4729|NCT02995408|"~     This study has three aims:~      Phase I: Through focus group interviews with expert clinicians, leaders of organizations,~     and parents with children with ASD, this study aims to identify the psychosocial needs of~     parents of children with ASD, specifically a) the types of concerns that parents find most~     difficult and stressful b) areas of concern that lack support and resources, and c) areas of~     need for education and skill training. This study also aims to gather feedback on the~     Benson-Henry Institute's Relaxation Response Resiliency Program (3RP).~      Phase II: Informed by Phase I findings, this study aims to develop and determine the~     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)~     program for parents of children with ASD.~      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,~     establishing efficacy of a virtual resiliency program.~   "
4730|NCT02995395|"~     This study will evaluate the role the balloon mucosal impedance may have in diagnosing and~     monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the~     balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.~   "
4731|NCT02995382|"~     This study aims to determine the Health Related Quality of life (HRQOL) (the physical,~     mental, emotional and social functioning) of patients with cubital tunnel syndrome following~     anterior intramuscular transposition, after one year.~   "
4732|NCT02995369|"~     The goals of this study are to determine if 1) placement times of pit and fissure sealants~     using the DryShield system differ from those when using the cotton roll isolation technique;~     and 2) there is a significant difference in patient preference between Dryshield and the~     cotton roll technique.~   "
4733|NCT02995356|"~     Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients~     will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)~     results and no embryo reported ultrasonography results. Plasma and cervical fluid samples~     will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase~     levels of samples will be compared between patients who have doubt for ectopic pregnancy and~     patients who have intrauterine pregnancy. Concentration of these proteins in samples will be~     evaluated. If any difference will be found between groups in favour of ectopic pregnancy,~     these results might be interpreted as these proteins useful for early detecting of the~     ectopic pregnancy.~   "
4734|NCT02995343|"~     Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated~     in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes,~     antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will~     search their archives for finding suitable patients for study. Investigators will especially~     notice being at least 6 month time of interval between surgery and evaluation time.~     Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of~     menstrual cycle. These results will be compared with normal postpartum women's results. It~     will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine~     arteries on ovarian reserve~   "
4737|NCT02995304|"~     In this double blind study, after taking an informed consent, 60 children aged between 7 and~     12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly~     divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV~     followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In~     the second group30 children who will receive the same dose of midazolam followed by saline~     premedication. All groups will be compared for pain score using visual analog scale (VAS)~     after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood~     pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication,~     every 10 min after premedication then every 5 min during and after anesthesia. 6 point~     sedation score and 4 points behavioral score will be monitored every 5 min after sedation.~     Four-point wake-up score will be recorded every 5 min. Time of first analgesic requirement~     and total morphine consumption during the first post-operative 8 hours will be recorded.~   "
4738|NCT02995291|"~     Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective~     at reducing the amount of time to reversal of local anesthesia with different dental~     anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to~     reverse anesthesia induced with the use of Bupivacaine.~      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial~     evaluating the difference in time required for the return of normal soft-tissue sensation~     and function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine,~     followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile~     physiological water (control).~   "
4739|NCT02995278|"~     The purpose of this minimal risk, observational survey is to document the accuracy,~     benefits, and how qualitative and quantitative results affect patients' plan of care.~   "
4740|NCT02995265|"~     To determine the effect of using a robotic exoskeleton to allow walking practice after~     stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary~     outcomes.~   "
4741|NCT02995252|"~     This is an observational, longitudinal, prospective study for sample collection and~     evaluation for future therapy or disease progression of chronic hepatitis B and C.~     Participants will be seen on an annual basis with optional additional visits for up to 10~     years and provide samples for research and evaluation of disease progression. In addition,~     there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of~     treatment with tenofovir alafenamide and blood collections with optional liver biopsies.~   "
4742|NCT02995239|"~     To compare the pharmacokinetics after administration of different formulation of CJ-12420~   "
4743|NCT02995226|"~     The purpose of this study is to check if patients, but also relatives (as they share~     familial and genetic risk factors), are having more difficulties in regulating a~     spontaneous, pleasant physical effort (doing too much) compared to healthy controls, and~     if physical efforts are participating to core symptoms of anorexia nervosa, such as more~     appetite (instead of less), less pain, more abnormal body image, and less cognitive~     flexibility.~      Such a result could help to further understand the role of difficulties with physical~     exercise as part of the phenotype of anorexia nervosa.~   "
4744|NCT02995213|"~     The investigators are proposing a pilot study, the purpose of which is to use accelerometers~     to quantify UE use (1 and two hand use) in people post-stroke from which the investigators~     will develop use-based feedback to improve recovery in the home setting. The objectives of~     this pilot study are to:~      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the~     home setting in individuals chronic post-stroke,~      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger~     (non-paretic) UEs, and~      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on~     unilateral and bilateral UE use.~      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and~     bilaterally in subjects post-chronic stroke pre and post feedback.~   "
4745|NCT02995200|"~     A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two~     hand use) in healthy controls and people post-stroke from which the investigators will~     develop use-based feedback to improve recovery in the home setting. The objectives of this~     pilot study are to:~      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the~     home setting in healthy individuals and individuals chronic post-stroke,~      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger~     (non-paretic) UEs,~      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic~     post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and~      iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on~     unilateral and bilateral UE use.~      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between~     healthy controls and subjects post-chronic stroke pre and post feedback (for the people~     after stroke).~   "
4746|NCT02995187|"~     This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial~     evaluating the efficacy and safety of Apatinib for third-line and later treatment of~     patients with small cell lung cancer.~   "
4747|NCT02995174|"~     Contrast balanced dichoptic videogame training has been found to improve sensory functions~     in adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but~     its effect on motor function, namely amblyopic eye fixation stability, is unknown.~     Furthermore, the effect of treatment in cases of mild amblyopia is not well understood. The~     aim of this study is to find out the difference on fixation stability, BCVA and stereopsis~     in mild amblyopes after 6 weeks' contrast balanced dichoptic video game training.~   "
4748|NCT02995161|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4749|NCT02995148|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4750|NCT02995135|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4751|NCT02995122|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4752|NCT02995109|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4827|NCT02994043|"~     The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse~     Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders~     (AUD) by implementing an 8-week long intervention and examining neurobiological,~     immunological, and epigenetic characteristics of AUD.~   "
4753|NCT02995096|"~     Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an~     important cause of mortality for this surgical population. In addition to tumor~     characteristics, It has been suggested that pre-treatment and sirolimus-based~     immunosuppression may affect recurrence and survival. With data from the European Liver~     Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of~     tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival~     after liver transplantation for HCC.~   "
4754|NCT02995083|"~     To investigate the clinical benefit of intra-articular injections of saline in patients with~     symptomatic osteoarthritis of the knee and compare the clinical response of saline to the~     current standard treatment with corticosteroids and an air injection placebo.~   "
4755|NCT02995070|"~     The aim of this study is to evaluate the influence of therapy with low-intensity laser~     technique associated with connective tissue graft for root coverage in smokers and compare~     the results with non- smokers~   "
4756|NCT02995057|"~     Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of~     humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety~     in patients. An alternative drug and vaccine delivery method is the use of hollow~     microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and~     bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As~     a result, they are better received by patients and do not induce needle anxiety. As the~     investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,~     the purpose of this study is to observe their biocompatibility and inertness.~   "
4757|NCT02995044|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4758|NCT02995031|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4759|NCT02995018|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4760|NCT02995005|"~     Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of~     transmission in most high and intermediate HBV endemic areas, despite existing WHO~     immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can~     prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires~     administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours~     of birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states,~     …owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in~     most settings. Clearly, global control of HBV transmission will require improved MTCT~     prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy~     will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without~     HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF),~     an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency~     against hepatitis B and its safety record in pregnant women. A randomized, controlled~     clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant~     women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg.~     However, before embarking on a RCT, several critical knowledge gaps need to be addressed~     including the ideal timing for TDF initiation. The purpose of this proposal is to address~     these knowledge gaps.~   "
4761|NCT02994992|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
4762|NCT02994979|"~     Delirium is an acute confusion that occurs in one third of hospitalized older adults. As~     compared to those without delirium, hospitalized patients with delirium have longer hospital~     stays, higher mortality, and increased risk of nursing home utilization. Substantial~     attention has been paid to developing, testing, and disseminating interventions to prevent~     delirium in the hospital but, to date, not in the nursing home setting. In a previous study~     we used known information on delirium risk factors to develop an intervention that can be~     delivered at onset of acute illness in nursing home patients. The current study is designed~     to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to~     determine, as compared to control, the effect of a multicomponent intervention targeting~     delirium risk factors on delirium frequency, delirium severity, cognitive and physical~     function decline, and hospitalization in nursing home patients with acute illness, and 2) to~     identify features of the intervention associated with occurrence of delirium and other~     outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a~     large, urban nursing home who experience onset of a change in condition according to~     established criteria, and enroll and assign them to intervention or control in a 1:1 ratio.~     Those assigned to intervention will receive daily visits from an Elder Life Specialist, a~     mobile Certified Nursing Assistant trained to provide services to counter risks for~     delirium, including dehydration, immobility, cognitive impairment, undernutrition, and sleep~     problems, for the duration of the acute illness and for 1 week following. Patients assigned~     to control will receive usual care from the unit-based nurses and the patient's primary~     team. Delirium will be assessed 5 days a week by a research assistant. Cognitive and~     physical function decline and hospital transfer will be ascertained during a 1 month~     follow-up period. We will compare outcomes between intervention and control, as well as~     examine associations between outcomes and intervention features such as number and duration~     of visits.~   "
4763|NCT02994966|"~     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care~     as one of three significant targets for pan-provincial action. The Diabetes Foot Care~     Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment~     of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key~     deliverables apply consistency in assessment, care, treatment and process standards, early~     intervention and complex wound care management, while optimizing health outcomes. To achieve~     these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province~     starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter~     Lougheed Hospital). The pilot site facilities were selected on the basis of their employing~     staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat~     patients with moderate and high-risk findings, and this care pathway will then be rolled out~     to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes~     Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the~     efficacy of a technological device developed by Alberta-based small-medium enterprise (SME)~     to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have~     recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart~     insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic~     offloading guidance to patients, in addition to enabling ongoing adherence tracking by the~     HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to~     improvements in wound prevalence, chronic wound care, and reduce the need for surgical~     intervention, including LLA.~   "
4764|NCT02994953|"~     The purpose of this study is to determine the safety, tolerability, and maximum tolerated~     dose (MTD) of NHS-IL12 when given in combination with a fixed avelumab dose in subjects with~     metastatic or locally advanced solid tumors.~   "
4765|NCT02994940|"~     Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical~     patients. The drug is available in an over the counter, inexpensive oral form as well as a~     considerably more expensive intravenous form. This study will compare opioid requirements~     and acetaminophen plasma levels post operatively for two dosing regimens to compare oral~     versus intravenous routes given pre operatively.~   "
4766|NCT02994927|"~     The aim of the trial is to assess the safety and efficacy of the orally-administered,~     selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining~     remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis~     (AAV).~   "
4767|NCT02994914|"~     This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental~     Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale,~     Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and  timed get up~     and go  tests) for elderly breast cancer patients. The score obtained at this evaluation~     will determine the radiotherapy scheme.~   "
4768|NCT02994901|"~     The goal of this cross-sectional study is to evaluate the difference in cytokine profiling~     approach and mitochondrial function between geriatric sarcopenic patients (group 1) and~     geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.~   "
4769|NCT02994888|"~     PROSPECT-C is a phase II study investigating the molecular markers of response or resistance~     to anti-epidermal growth factor receptor (EGFR) antibodies.~   "
4770|NCT02994875|"~     The objective of this research is to identify the functional neural mechanisms (as assessed~     using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained~     individuals with cocaine dependence.~   "
4771|NCT02994862|"~     In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla~     chinensis before Bonding of laminate veneers with adhesive resin cement provide better~     survival rate than conventional Bonding method~   "
4772|NCT02994849|"~     Premature babies, born several weeks before their due date, are often very ill in the first~     weeks and months of life, compared with those born at full term. Because babies' brains and~     bodies are still developing at this time, early birth puts them at increased risk of later~     problems with health and development. It is important to do everything possible to try to~     improve the overall health of these children. Not only will this help children and families,~     but it will also help to understand the correct amount and type of care they will need from~     the NHS in the future. At present, England has three types of neonatal units: Neonatal~     Intensive care units (NICUs) that can care for the most sick and most premature babies,~     Local Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special~     Care baby units (SCBU) that care for larger premature babies who are generally well, but~     need time to grow and develop before going home.~      For those premature babies born between 27 and 31 weeks of pregnancy, there is no~     information on whether they benefit from being looked after in one type of unit or another.~     At present there is no guidance, so these babies may be looked after in either LNUs or~     NICUs. Babies who are born at this stage of pregnancy cannot be looked after in a SCBU and~     sometimes need to be moved after birth to either a NICU or LNU. There are 84 LNUs and 45~     NICUs in England. In 2014, about half of these babies were cared for in a NICU and half in a~     LNU. There is the need to know whether babies born between 27 and 31 weeks are best cared~     for in a NICU or LNU or if it does not matter.~      The main things that control where a baby is born are where the mother has her antenatal~     care, and where there is a cot available for the baby. A mother may have antenatal care in a~     hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is~     going to have her baby early, she cannot be directed, at the time of her choosing her~     hospital for antenatal care, where to go to for care. There is uncertainty before birth~     which baby is likely to require intensive care, but usually the less mature babies need more~     intensive care.~      In this study to find out where it is best to care for babies born at 27-31 weeks of~     pregnancy, the study will look at which type of unit: a) leads to the best outcome for~     babies born at each week of pregnancy in this range; b) is most cost-effective for families~     and the NHS and c) best considers views and needs of parents and staff caring for babies.~   "
4773|NCT02994836|"~     This study will be a multicentre prospective randomized trial to assess the percentage of~     patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission~     at one year compared to those in which the treatment is continued at stable doses~   "
4774|NCT02994823|"~     The investigators compared a pooled mother's expressed breastmilk for 24 hours with~     individual pump session collection of milk to provide a more consistent caloric product~     without increasing bacterial contamination.~   "
4775|NCT02994810|"~     The benefits of breastfeeding are increasingly known of the population and breastfeeding~     rates in the country have been increasing, but still are below satisfactory to the Ministry~     of Health (MH) and the World Health Organization (WHO).~      Simple Strategies to guide and support the mother contributes to increasing knowledge about~     breastfeeding and can have positive impacts on breastfeeding rates.~   "
4776|NCT02994797|"~     Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow~     patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study~     the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients~     with sicca syndrome and pSS.~   "
4777|NCT02994693|"~     The goal of this research is to determine the natural history of Barrett's esophagus (BE)~     using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.~   "
4778|NCT02994680|"~     The purpose of this randomized controlled field trial is to determine whether a liquefied~     petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen~     exposure to household air pollutants and improves cardiopulmonary health outcomes when~     compared to usual cooking practices with open-fire biomass-burning stoves in adult women~     aged 25-64 years.~   "
4779|NCT02994667|"~     The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in~     patients undergoing permanent pacemaker placement after TAVR.~      As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular~     conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients~     undergoing permanent pacemaker placement after TAVR.~   "
4780|NCT02994654|"~     The overall purpose of this is study to provide continued access to the ReCell device~     following completion of protocol CTP001-6, and allow for collection of supplementary~     clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in~     subjects with acute thermal burn injuries who require skin grafting for closure of burn~     injuries.~   "
4781|NCT02994641|"~     In the surgical intensive care unit (SICU), goals of critical care are often discussed in~     long-term ventilated patients around the time of extubation. Muscle weakness predicts~     extubation failure but formal muscle strength assessment by the Medical Research Council~     scale is time-consuming and not part of the daily clinical exam. In this observational~     study, we hypothesize that COMA measurement, routinely used by the SICU nurses, is a~     reliable and valid predictor for patients' SICU outcomes. This prospective observational~     study is carried out within a consecutively enrolled cohort of adult patients who are~     extubated in two SICUs at Massachusetts General Hospital, Boston.~   "
4782|NCT02994628|"~     In a previous study at the Appalachian State University (ASU) Human Performance Laboratory~     at the North Carolina Research Campus (NCRC), investigators showed that cyclists ingesting~     about one-half of a banana with water every 15 minutes cycled 75-km faster (5%) than with~     water alone. The polyphenols (i.e., chemicals in plants with health benefits) in the banana~     improved the capacity to counter oxidative stress, and the sugars lowered post-exercise~     inflammation. The cyclists reported some gastrointestinal discomfort, however, from the high~     volume of bananas consumed. Dole Foods, the sponsor of this study, has a banana collection~     that includes many different varieties, including the Mini banana that has a higher sugar~     (50%) and phenolic (63%) content than the typical banana (Cavendish) available in stores.~     Thus athletes should experience similar performance benefits from a smaller volume of Mini~     compared to Cavendish bananas, and reduced gastrointestinal symptoms. If study results are~     favorable, Dole Foods may market the Mini banana as the sport banana.~      The purpose of this study is to compare ingestion of Mini and Cavendish bananas with an~     equicaloric, sugar-only beverage or water on 75-km cycling performance and post-exercise~     oxidative capacity and stress, inflammation, immune function, muscle damage and soreness,~     and gastrointestinal symptoms.~   "
4783|NCT02994615|"~     Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be~     assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter~     monitor.~   "
4784|NCT02994602|"~     This is a two-center, open-label study conducted in healthy male and female volunteers at~     two academic research centers. The study will consist of three single applications of the~     Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male~     participants followed 2 hours later by supervised skin contact by the non-dosed female~     participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing~     Barrier to the Application will be assessed.~   "
4785|NCT02994589|"~     The investigators objective is to compare OASIS wound matrix with other commonly used~     dressings available for the donor site in split thickness skin grafting in order to~     determine which dressing provides the best outcome based on pain level, time to healing and~     aesthetic outcome.~   "
4786|NCT02994576|"~     Based on the efficacy of immunotherapies in advanced disease with a reasonable safety~     profile/tolerability we could hypothetisize that, immunotherapy should work best in the~     situation of minimal residual disease, Two clinical trials are ongoing to test the role of~     immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial~     with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo~     for patients with early stage NSCLC after resection and completion of standard adjuvant~     therapy, and the second randomized phase III trial (NCT02273375) will evaluate the efficacy~     of an anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy~     in completed resected stage IB-IIIA NSCLC and completed standard ACT.~      The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently~     unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced~     NSCLC where the tumor has not been removed which could produce higher immunogenicity and~     based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and~     efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage IB, II, or~     IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.~      Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper~     abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic~     disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will~     be performed according the standard clinical guidelines.~   "
4787|NCT02994563|"~     Prospective, single-arm, open label, Safety and Performance clinical investigation.~   "
4788|NCT02994550|"~     The aim of this study is to compare different FSH/LH ratios in controlled ovarian~     stimulation~   "
4789|NCT02994537|"~     The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory~     and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH).~     At phase 1, the investigators focus on studying of the clinical characteristics of acute~     autoimmune hepatitis, and then will study the difference about treatment effects between~     acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that~     drug induced AIH have some special characteristics that may be beneficial to distinguish it~     with durg induced liver disease. Therefore the investigators will do some studies about drug~     induced AIH or other disease which maybe related to the onset of AIH.~   "
4790|NCT02994524|"~     .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal~     incontinence that is associated with less sphincter division,It is indicated in patients~     with transsphincteric fistula in whom lay open is expected to be associated with significant~     incontinence .~   "
4791|NCT02994511|"~     This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive~     factor of response/resistance to anticancer treatment. The project will involve the~     collection and study of the archived tumour tissue where available (mandatory), serial blood~     samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an~     early phase clinical trial.~   "
4792|NCT02994498|"~     The primary study objectives are~        1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the~          maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects~          with advanced melanoma (Phase I)~        2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on~          therapy to dacarbazine in subjects with advanced melanoma in terms of progression free~          survival (Phase IIa)~   "
4793|NCT02994485|"~     Portal hypertension is not a disease in itself. Rather, it is an indication of an illness,~     caused mostly by chronic lesions of the liver because of distinct causes, such as viral~     infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic~     vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal~     hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by~     more than 5 mm Hg.~   "
4825|NCT02994069|"~     Patients will receive standard of care radiation therapy to the primary tumor of the head~     and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin~     or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin~     toxicity and the level of reactive oxygen species generated by the drug in subjects with~     squamous cell carcinoma of the head and neck treated on this trial.~   "
4794|NCT02994472|"~     The Investigators institution has used a meal consisting of mashed potato, peas and~     Beanfeast (soya mince) for gastric emptying studies for a number of decades. Validation of~     the study method was purportedly performed when the study was first implemented at the~     hospital, however no historical data has been found. The current normal ranges are also~     unsubstantiated. There is scientific justification for this research because in vivo studies~     are instrumental to the validation of a new procedure. There is a need for a meal~     preparation that is palatable and meets dietary requirements (vegetarian, gluten free~     e.t.c.) of patients as the diagnosis depends on ingestion of the radiolabelled meal. In~     addition, reliable normal ranges will ensure that the clinical diagnosis is accurate.~     Scientific justification extends beyond the local department as publishing the data acquired~     will allow other hospitals to adopt the same test meals and normal ranges, leading to~     standardisation of the clinical protocol employed across the UK. Since the investigators~     institution are recognised as the leading Nuclear Medicine GI centre in the UK and have~     previously carried out audits and in vitro testing in the area of gastric emptying, it seems~     fit that they should lead the national change in protocol.~      The proposed study will involve recruitment of healthy volunteers who will eat a meal~     containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma~     camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy~     volunteers (18-70 years old, no history of gastrointestinal problems or other serious health~     issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will~     be conducted on site i.e. within the Nuclear Medicine department at City hospital.~   "
4795|NCT02994459|"~     People who are obese often have insulin resistance (inability of insulin to properly control~     blood sugar) and high blood sugar. However, not all people with obesity have this problem.~     About one third of people with obesity have normal sugar metabolism (the way your body uses~     sugar). The reasons why some people with obesity have a problem with blood sugar control and~     others do not are not entirely clear. It is thought that impaired muscle sugar uptake is the~     main problem related to high blood sugar in people with obesity. However, adipose tissue~     (fat tissue) also consumes a substantial amount of blood sugar. Therefore, it is unclear~     whether muscle or adipose tissue (fat tissue) are primarily responsible for altered blood~     sugar concentrations in persons with metabolically abnormal obesity (MAO) (those with~     insulin resistance and high blood sugar), compared to those with metabolically normal~     (healthy) obesity (MNO), or whether healthy adipose tissue (fat tissue) expansion in MNO~     people compared with lean people provides a vessel for blood sugar removal that helps~     maintain normal blood sugar concentration.~      Accordingly, the investigators will determine the amount of sugar that is taken up by the~     body and in the cells of adipose tissue (fat tissue) and muscle by infusing labeled sugar~     into the blood and looking at its disappearance from blood and appearance in adipose tissue~     (fat tissue) and muscle. The investigators will also determine how well insulin, a hormone~     that controls blood sugar, turns on signals that stimulate sugar uptake in fat and muscle~     cells. These studies will be done after an overnight fast and during an infusion of sugar~     and insulin (hyperinsulinemic-euglycemic clamp), in sex- and age-matched MNO and MAO people~     and a group of sex- and age-matched healthy lean people.~   "
4796|NCT02994446|"~     The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter~     and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)~   "
4797|NCT02994433|"~     Most clinical major depression responds to standard treatments (medication and~     psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond~     to these treatments and are referred to as treatment-resistant major depression (TRMD). New~     treatments for TRMD are needed, and one promising line of research are drugs known as~     N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our~     group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This~     application proposes to take the next important step in understanding how nitrous oxide~     exerts its effects in the human brain by using state-of-the-art brain neuroimaging~     (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy~     volunteers and comparing the results to a group of TRMD patients.~      This study involves exposing 20 non-depressed healthy participants and 20 TRMD participants~     to nitrous oxide and a placebo gas, to compare their brain images before and after each of~     the inhalation sessions. Sessions will be separated by at least one month to prevent~     treatment effects from carrying over into the following session. All willing and eligible~     subjects will undergo up to six functional connectivity MRI scans, and two inhalation~     sessions. Functional imaging in the brain will allow us to trace the interconnections~     between various parts of the brain, including those involved with emotion and depression.~      Other procedures will involve screening materials to ensure safety of the participants~     before beginning the study (i.e. no MRI scan contraindications) and that subjects meet~     eligibility criteria to being in the targeted age range, depression/non-depressed state,~     neurological disorder history, and no medication exclusions.~   "
4798|NCT02994420|"~     The purpose of this study is to better understand how female sex hormones influence the food~     intake in the gut system through the release of satiety hormones as well as through central~     regulative mechanisms in the brain that subsequently contribute to the control of eating in~     healthy women at different stages of the ovarian cycle.~   "
4799|NCT02994407|"~     The trial is conducted in Asia, Europe and North America. The aim of the study is to~     evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in~     patients with severe haemophilia A.~   "
4800|NCT02994394|"~     To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at~     15 and 30 mg in healthy adult male subjects.~   "
4801|NCT02994381|"~     This will be an open-label, non-randomized, single oral dose study in healthy male subjects.~      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),~     containing NMT 1.3 MBq (37 μCi) 14C.~   "
4802|NCT02994368|"~     The purpose of this study is to understand the rate of progression of all stages of~     choroideremia using a variety of assessments performed in the clinic including visual field~     measures, specialized photography of the eye and participant-reported visual problems~   "
4828|NCT02994030|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Duchenne~     disease from plasma~   "
4803|NCT02994355|"~     Location: Family Planning Clinics in Mombasa County, Kenya~      Introduction:~      Integration of HIV treatment and prevention with family planning (FP) services is a~     promising approach for optimizing delivery of comprehensive healthcare for HIV-positive~     women, as well as prevention services for those who are negative. In Mombasa County, the~     USAID-supported AIDS Population and Health Integrated Assistance II Program revised the FP~     Clinic Register to capture HIV testing in 2008. However, the rate of HIV testing in FP~     clinics remains low. Our overarching objective is to assess the effectiveness, costs, and~     budget impact of implementing the systems analysis and improvement approach (SAIA) to~     increase HIV testing in FP clinics in Mombasa County.~      Methods:~      The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA~     approach versus usual procedures on rates of HIV testing in first-time attendees at 20~     intervention versus 20 control FP clinics in Mombasa County. The investigators will compare~     HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control~     facilities after an additional year, during which FP clinics in the intervention arm will be~     encouraged to continue to use the SAIA tools with minimal support from the study team as the~     Mombasa County Ministry of Health will take ownership of implementation. Lastly, the~     investigators aim to estimate the incremental cost and budget impact of applying SAIA versus~     standard of care using an activity-based approach.~      Anticipated Results:~      The investigators anticipate that SAIA will produce significant and sustained improvement in~     HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to~     control facilities. The use of a rigorous study design will provide strong evidence to guide~     integration of HIV testing into FP services in a wide range of settings. The inclusion of~     costing and budget impact analyses will assist policy makers in reaching informed decisions~     about implementation.~      Anticipated Conclusion:~      By addressing the crucial first step in the linkage of HIV and FP services, this research~     holds considerable promise for improving women's health by opening the gateway to HIV care~     and prevention.~   "
4804|NCT02994342|"~     Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal~     dryness in post-menopausal women with vaginal atrophy in comparison to a group of~     non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at~     4-week follow-up only for women applying ZP-025 vaginal gel.~   "
4805|NCT02994329|"~     This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of~     oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of~     home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV~     status among the general adult and adolescent population.~      The primary outcome of the trial is the proportion of individuals who know their HIV status,~     defined as a self-report of being HIV positive or accepting testing (standard or self~     testing) from the CHW.~      Embedded within the impact evaluation is a process evaluation that will explore the fidelity~     of the implementation of the intervention and outputs of the intervention. Qualitative data~     on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any~     impacts on relationships (including between couples and with CHW) associated with use of~     HIVST kits.~   "
4806|NCT02994316|"~     Children with diabetic ketoacidosis risk neurological complications such as cerebral edema~     with high morbidity. To prevent cerebral edema, it is essential to control correction of~     hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic~     ketoacidosis don't always permit an optimal care.~      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.~      Therefore, monitoring of plasma copeptin levels could be of interest in children with~     diabetic ketoacidosis and risk of sévère neurological complications.~   "
4807|NCT02994303|"~     In patients with Fabry disease, this research study explores the presence of podocytes in~     their urine as a potential non-invasive biomarker for baseline kidney disease; and explores~     changes in the quantity of podocytes in their urine over time as a predictor for kidney~     disease progression. To accomplish this, the investigators will evaluate the quantification~     of podocytes in the urine of Fabry disease patients at baseline and longitudinally over~     time. This study requires a single patient visit, during which the patient provides a urine~     specimen. The research team will then collect the patient's kidney function data proximate~     to the time of urine collection, and follow the patient's kidney function data~     longitudinally over the five years of this study by reviewing their medical charts. The~     study offers no interventions.~   "
4808|NCT02994290|"~     The purpose of the proposed pilot study is to assess the implementation of IPP-HPV~     immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and~     facilitators of this intervention to optimize its feasibility and effectiveness. It is~     imperative that innovative interventions be developed to achieve comprehensive utilization~     of this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical~     and other HPV associated cancers, and address cancer disparities.~   "
4809|NCT02994277|"~     The purpose of this study is to use closed-loop systems with the algorithms designed by the~     University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad~     Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion~     of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).~   "
4810|NCT02994264|"~     The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent~     chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of~     the extremities at the investigators institution paired with patients treated by adjuvant~     radiation therapy~   "
4811|NCT02994251|"~     The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin~     in combination with conventional trans-arterial chemoembolization therapy in adult patients~     with advanced ICC. 25 patients will be enrolled over the course of 2 years, with an~     additional 1.5 years for patient follow-up.~   "
4812|NCT02994238|"~     The goal of this study is to determine whether a sensor-enabled, clinically integrated,~     mobile health asthma program can improve asthma outcomes among 4-11 year old children with~     moderate-to-severe asthma.~   "
4813|NCT02994225|"~     The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes~     is of paramount importance in the subsequent management of this cancer and surgery of~     invasive breast cancer involves axillary lymph node dissection (ALND). To preserve arm~     lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic~     drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is~     uncertain.~      The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of~     draining lymphatics. The project aims to train surgeons to the technique and to identify~     predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary~     pathological parameters to better select patients who would not require removal of the ARM~     node in the future~   "
4826|NCT02994056|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with~     ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection~     and Child-Pugh-Turcotte (CPT) class C cirrhosis.~   "
4814|NCT02994212|"~     Community-based management of severe acute malnutrition (SAM) has been shown to be safe and~     cost-effective, but program coverage remains low. New treatment models that maintain high~     levels of clinical effectiveness but allow for increased coverage are still needed. A~     reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic~     foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study~     aims to describe the safety and feasibility of a monthly distribution of ready-to-use~     therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to~     treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a~     non-randomized pilot intervention study in which 115 children eligible for the outpatient~     treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were~     taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain,~     (mid-upper arm circumference) MUAC gain, weight loss > 5%, and the development of edema.~     Unannounced household spot checks were conducted over 4 weeks to assess household~     utilization of RUTF and storage practices.~   "
4815|NCT02994199|"~     The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted~     game controllers on quality of game play, enjoyment, and energy expenditure during active~     video gaming in persons with mobility impairments. The controllers to be evaluated include~     off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.~   "
4816|NCT02994186|"~     Bariatric surgery is the most effective, long-term treatment for morbid obesity, and~     consistent with previous findings, individuals who lose significant weight after surgery~     also have improved cognition or brain function. The mechanisms behind these cognitive~     improvements are currently unknown, but are the focus of much research effort. The goal of~     this pilot study is to thoroughly describe these changes in surgical versus medical weight~     loss patients over time in a repeated measures fashion.~   "
4817|NCT02994173|"~     To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous~     patient-controlled analgesia bolus dosing and effects in patients scheduled for~     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation~   "
4818|NCT02994160|"~     Our goal is to temporarily implant the following groups for 90 days:~        1. Three human partial hand amputees (amputated at the level of the hand) with 2 FAST-LIFE~          electrodes, one inserted into the motor fascicle of the ulnar nerve and the other into~          the sensory fascicle.~        2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2~          FAST-LIFE electrodes in the ulnar nerve (one in the motor fascicle, one in the sensory~          fascicle) and 4-5 FAST-LIFE electrodes in the median nerve (one in the motor fascicle,~          one in each of the 3-4 sensory fascicles).~   "
4819|NCT02994147|"~     Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic~     synovitis, cartilage damage and bony destruction. Currently available treatments of HA,~     including analgesics, NSAIDs, and hyaluronic acid, are predominantly directed toward the~     symptomatic relief of pain and inflammation, with no or little effect on joint cartilage~     degeneration. AC201CR, a control released formulation of AC-201, demonstrates~     anti-inflammatory effects by reducing NLRP3 inflammasome assembly. AC-201 is also unique in~     that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown~     cartilage-sparing properties in animal studies. The study is designed to evaluate the joint~     structure-modifying and symptom-relieving effects, safety, and tolerability of AC-201CR in~     subjects with HA.~   "
4820|NCT02994134|"~     The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or~     high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and~     postural control in sedentary healthy adults.~   "
4821|NCT02994121|"~     In this longitudinal prospective natural history study of multiple sclerosis (MS), the~     overarching goal is to understand the factors that influence individual variation in disease~     trajectory and treatment response and pave the way for realizing precision medicine in MS.~     Because MS is a chronic neurological disorder, this observational cohort study will span a~     30-year time frame.~   "
4822|NCT02994108|"~     Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer~     (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g.,~     receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk~     for HPV infection and are disproportionately affected by HPV-related cancers. A safe and~     effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the~     U.S. have been low, particularly among males. To remedy this gap, the goal of this study is~     to develop and pilot test a text messaging intervention to increase HPV vaccination in young~     MSM.~      The study has two specific aims:~        1. Develop, iteratively refine, and pre-test messages using a formative research procedure~          for designing targeted health interventions. The procedure consists of the following~          steps: 1) conduct online focus groups, an online survey, and in-depth interviews to~          inform message content, 2) draft initial messages based on focus group findings and~          pilot data, 3) refine message content and assess acceptability using content advisory~          teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta~          test the protocol.~        2. Test the feasibility, acceptability, and preliminary efficacy of the Txt2Protect (T2P)~          text messaging intervention in a pilot randomized controlled trial (RCT). To achieve~          this aim, 460 unvaccinated MSM (ages 18-26) who live in the Chicago metro area will be~          randomly assigned to the treatment (T2P) or control condition. The treatment condition~          will receive a culturally appropriate text messaging-based HPV vaccination intervention~          based on the Information, Motivation, and Behavioral Skills model, whereas the control~          condition will receive a text messaging-based sexual health intervention that includes~          basic facts about HPV vaccination readily accessible online.~      Primary outcome measures include intervention feasibility (e.g., retention in the trial),~     acceptability (satisfaction with the intervention), and preliminary efficacy as determined~     by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at~     the end of the 9-month trial.~      The study team hypothesizes that participants in the T2P condition (vs. control) will report~     greater acceptability of the intervention and will be significantly more likely to initiate~     and complete the 3-dose HPV vaccine series by the end of the trial.~   "
4823|NCT02994095|"~     This was a pilot study to assess the feasibility and acceptability of training Community~     Health Agents in Motivational Interviewing in real-life primary care centers.~   "
4824|NCT02994082|"~     This is a pilot study designed in an effort to develop and improve access to effective~     treatments for tobacco use in rural Veterans using a tailored intervention approach.~     Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco~     cessation which concomitantly addresses comorbid issues commonly experienced by rural~     tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about~     weight gain. The objectives are to:~        1. Evaluate the feasibility of an individually-tailored telephone intervention for rural~          smokeless tobacco users~        2. Examine the impact of the intervention on treatment utilization, patient satisfaction,~          and smokeless tobacco cessation.~   "
25858|NCT02718690|"~     The purpose of this study is demonstrate the importance of density current of TENS in the~     effect about H-reflex in healthy volunteers.~   "
4829|NCT02994017|"~     The objective of study is to prospectively determine if CPET with blood gas analysis should~     have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.~     Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test~     or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients~     will perform a maximal exercise test on a cycloergometer during the inclusion visit, with~     pulmonary function testing and a six-minute walk test. The study will also include a visit~     every 6 months with: body mass index calculation, pulmonary function testing with DLCO~     (diffusing lung capacity for carbon monoxide), a six minute walk test, and~     antibacteriological study of sputum. The results of this study could help identify earlier~     the patients for referral to a lung transplantation centre, by using the usual criteria and~     the CPET abnormalities.~   "
4830|NCT02994004|"~     Hospital physicians are increasingly facing budgetary constraints that might have an impact~     on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might~     translate into role conflict and ambiguity. We explore the medical decision-makingprocess of~     physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated~     medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.~     We will compare the fMRI data between the 2 modalities.~   "
4831|NCT02993991|"~     This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune~     effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous~     cell carcinoma of the oral cavity.~   "
4832|NCT02993978|"~     The purpose of the study is to evaluate the effect of changes in the care environment in~     pediatric radiotherapy. The definitions of the changes is a part of the study, and is~     constructed in collaboration with the institute of design at Umeå University. The~     implementation is however not part of the study, but done as part of Clinical routine.~      The study consist of two parts, where the first 1.5 years are a Control phase where the~     changes are designed and also function as a baseline period. The following 1.5 years are the~     case period where the Changes that are accepted for Clinical implementation are implemented.~      The impact of the changes are evaluated using surveys and interviews of both parents and~     children~   "
4833|NCT02993965|"~     The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and~     sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct~     centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates~     among adolescents ages 11-17.~   "
4834|NCT02993952|"~     One of the major challenges faced by researchers working in the field of rehabilitation~     science is the ability to provide integrative approaches to the use of clinical practice. In~     this context it becomes increasingly necessary to construct investigative approaches, so~     that they can reach clinical practice in a shorter period of time,since the large volume of~     information produced globally does not impact in the short or medium term on new therapeutic~     recommendations. Among the various chronic painful entities, there is chikungunya fever as a~     highlight for having a rich clinical chronology in relation to pain. Its therapy is used~     done by drugs in almost all national and international consensuses, therefore therapy~     against pain in chikungunya fever is limited during the rehabilitation process. It is very~     important that the science of rehabilitation enhances methods of noninvasive brain~     modulation that enable, through the excitation or inhibition of specific cortical areas to~     produce pain inhibiting effects, providing a simple and low cost treatment to the clinical~     routine.Technological advances and non-invasive techniques to modulate brain function have~     been developed, for instance, Transcranial Direct Current Stimulation (tDCS).~      The objective of the present project is to present the tDCS as a new modality of physical~     rehabilitation for the patient with chronic pain resulting from chikungunya fever. The~     purpose of the study is to present physical, behavioral and social results of the~     application of tDCS in chikungunya fever, suggesting an improvement in the quality of life~     and functional status of the individual.~   "
4835|NCT02993939|"~     Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle~     brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may~     not be tolerated in patients with chronic pulmonary disease.~      This RCT will compare the classic Interscalene block with combined infraclavicular block~     plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.~      Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are~     pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.~   "
4836|NCT02993926|"~     The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the~     treatment of Central Precocious Puberty (CPP) in Chinese participants.~   "
4837|NCT02993913|"~     Phase I dose escalating trial. Primary objectives of this study are to assess the safety and~     tolerability of Simmiparib following single and multiple oral doses in patients with~     advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting~     toxicity (DLT), and pharmacokinetic profile.~      The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.~   "
4838|NCT02993900|"~     This research is being done to evaluate multimodality imaging, including magnetic resonance~     imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy~     takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose~     of this study is to investigate the ability of MRI to successfully guide the placement of~     the brachytherapy applicator necessary to treat participants' gynecologic cancer. The~     Investigators want to see if the use of MRI will do a better job of assessing the tumor at~     the time of brachytherapy than the routinely used CT scan. The Investigators also want to~     determine if the use of MRI will enable doctors to reduce the radiation dose received by the~     body during the process of treating the tumor.~   "
4853|NCT02993705|"~     Multicenter phase II study on trabectedin in patients advanced uterine and ovarian~     carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable~     toxicity. Disease response evaluation will be assessed every 9 weeks.~   "
4854|NCT02993692|"~     The aim of study was to compare the hemodynamic responses and adverse events associated with~     nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct~     laryngoscope (DLS) in children undergoing general anesthesia for outpatient dental surgery.~     Eighty children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under~     general anesthesia and who required nasotracheal intubation were included.~   "
4839|NCT02993887|"~     The investigators will conduct a randomized clinical trial pilot study to examine the~     effectiveness of a theoretically based intervention (called ReMind) encompassing two key~     components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness~     meditation delivered using a smart phone application (Stop, Breathe & Think™) with an~     intervention (Mind Only) that consists only of daily mindfulness meditation. Both components~     of the intervention have been tested separately (but not combined) and both interventions~     can be self-tailored, which meets the vital need for these caregivers to engage in~     self-management activities when it is convenient for them. The investigators will test the~     two arms of the intervention in 30 parents of technology-dependent children, 15 parents in~     each group. The investigators will collect mixed data at baseline, 3 months and 6 months~     after subject enrollment to describe changes in proximal and distal outcomes. The~     investigators aim to:~        1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and~          Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive~          factors, resourcefulness) and determine if there are different effects between ReMind~          and Mind Only interventions.~        2. Evaluate the differences in distal psychological (Mental Health Related Quality of~          Life, Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical~          (Physical Health Related Quality of Life), and cost outcomes between subjects in the~          ReMind and Mind Only arms over time.~        3. Determine the moderating effects of parents' social support, demographics (age, gender,~          family income) and children's functional status on (a) proximal outcomes and the~          relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis~          Function, stress, cognitive factors and distal outcomes.~        4. Evaluate the impact of decentering on the association between the interventions and the~          proximal and distal outcomes.~        5. Explore differences in neurological processing (DMN and TPN) and decentering in~          proximal and distal outcomes associated with each intervention.~   "
4840|NCT02993874|"~     The aim of this study will be to verify the effect of creatine supplementation associated to~     clinical treatment of the functional capacity in patients with intermittent claudication.~   "
4841|NCT02993861|"~     The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to~     characterize the pharmacokinetics and safety of four oral anti-epileptics drugs~     (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if~     inadequate enrollment}, topiramate, and ocarbazepine) in a non-randomized sample of obese~     children and adolescents. The study's duration will be up to eleven days (up to seven days~     of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18~     years will be identified through outpatient clinic schedules and inpatient admissions at~     each clinic site. Participants receiving at least one of the study drugs per local standard~     of care will have pharmacokinetic concentrations in plasma drawn according to the specific~     dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip~     ratio, medical history, concomitant medication history, documentation of study drug oral~     intake, adverse effects, and physical examination. The sample size will include 24~     participants for each anti-epileptic drug (total 96).~   "
4842|NCT02993848|"~     The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes~     registry.~      There currently exists a paucity of outcomes data in the literature on this patient~     population. The NASCon registry will be a resource in which investigators can conduct~     adequately powered clinical outcomes research resulting in higher quality research with~     meaningful results, improved patient care, and evidence-based advancement for the treatment~     of scapula fractures. Registries can lead to significant discoveries in comparative~     effectiveness specifically in areas where randomized control studies are not possible.~     Collecting post-treatment (operative and non-operative) patient outcome data for similar~     injury patterns has been shown effective in uncovering optimal standards for treatment.~   "
4843|NCT02993835|"~     Determination of fractional iron absorption from bouillon fortified with 3 labeled iron~     compounds.~   "
4844|NCT02993822|"~     The purpose of this study is to determine the effectiveness of three doses of orvepitant,~     taken once a day, in the treatment of chronic refractory cough.~   "
4845|NCT02993809|"~     The intent of this clinical study is to evaluate the safety of the injection composed of~     autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract~     (PRPE) for the treatment of critical limb ischemia.~   "
4846|NCT02993796|"~     The purpose of this study is to develop a clinical database of individuals diagnosed with~     Krabbe disease in order to determine which symptoms herald the onset of clinical disease in~     the various phenotypes of Krabbe disease; to determine whether level of GALC enzyme~     activity, or a specific genetic mutation predict the clinical course; and to determine which~     neurodiagnostic tests predict onset and/or severity of the disease.~   "
4847|NCT02993783|"~     The purpose of this study is to assess the initial activity, tolerability, safety and to~     identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for~     treatment of steroid-refractory acute intestinal GvHD in participants who have undergone~     allo-HSCT.~   "
4848|NCT02993770|"~     All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic~     in Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary~     nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic~     consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR~     and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive~     regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo~     comprehensive ophthalmology examinations including best corrected visual acuity (BCVA),~     relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated~     fundoscopy with 78 D lens. Past history and review os systems will be elicited for~     medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries,~     epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ~     transplant, immunosuppressive drugs and immunodeficiency disorders.~      All operations will be performed under general or local anesthesia, based on patient and~     surgeon preferences.~      Surgical Technique:~      All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in~     endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described~     by Wormold.~      Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal~     sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing~     lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed~     through puncta into nasal cavity and stabilized and will be kept for 2 months. After~     operation patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop~     phenylephrine 0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin~     four times daily for one week.~      External DCR will be performed in a conventional manner [2]via a nasal side straight skin~     incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will~     be separated using blunt dissection to expose the periosteum overlying and medial to the~     anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm~     in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an~     H incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta~     into nasal cavity of stabilized by multiple square knots at the end. The small posterior~     flaps will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0~     vicryl sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl~     sutures. Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner.~     Nasal packing will not be placed. All Ext-DCR operations will be performed by one of the two~     expert ophthalmic plastic surgeons (F.P and A.K.).~      The amount of bleeding will be estimated and recorded by the subtracting the total suction~     reservoir from the amount of irrigated fluid through syringe during operation. Time of~     operation will be estimated and recorded from the time of anesthetics injection to removing~     the drape.~      One week after operation patients will be asked to report post-operative pain and discomfort~     by visual analogue score scale (0-10).~      27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is~     healed, and complications, if any, will be detected and recorded in the special data sheets.~     Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining~     and any complications will be detected and recorded. Dye disappearance test (DDT) will be~     checked and recorded. Epiphora will be recorded according to modified Munk epiphora staging~     scale.~      Two months after operation, ocular surface will be checked by fluorescein for staining of~     cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded~     according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye~     test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS)~     visual analogue scale will be checked in months 2, 6, 12, 18 and after operation.~     Satisfaction will be checked 2 mo and 18 mo after operation by VAS. Any grade of daily~     epiphora or return of fluid>20% through opposite punctum in irrigation test or negative FDDT~     (absence of fluid passage) will be regarded as functional or anatomic failure, respectively.~     Any complication will be recorded in the specific forms.~      All pre-operative and post-op examinations will be performed by a masked senior~     ophthalmology resident subjective data will be checked and recorded by a trained nurse~   "
4849|NCT02993757|"~     The aim of the study is to assess the safety and immunogenicity of the CYD dengue vaccine~     when administered concomitantly or sequentially with Gardasil® (Human Papillomavirus~     Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant).~      Primary objectives:~        -  To demonstrate that the humoral immune response (in terms of geometric mean~          titers[GMTs]) to Gardasil after concomitant administration is non-inferior to~          sequential administration with the CYD dengue vaccine measured 28 days after the last~          dose of Gardasil.~        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after~          concomitant administration is non-inferior to sequential administration with Gardasil~          measured 28 days after the last dose of the CYD dengue vaccine.~      Secondary Objectives:~        -  To demonstrate that the humoral immune response (in terms of seroconversion) to~          Gardasil after concomitant administration is non-inferior to sequential administration~          with the CYD dengue vaccine measured 28 days after the last dose of Gardasil~        -  To describe the humoral immune response to Gardasil at baseline and after each dose of~          Gardasil in each and any group~        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after~          each dose of the CYD dengue vaccine in each and any group~        -  To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose~          in each group.~   "
4850|NCT02993744|"~     It is the aim of this study to detect the effect of Betamethasone on the maternal~     inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under~     threat of preterm delivery, for example because of a cervical infection.~   "
4851|NCT02993731|"~     This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly~     nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult~     patients with Metastatic Pancreatic Ductal Adenocarcinoma.~   "
4852|NCT02993718|"~     Under the hypothesis that dexmedetomidine sedation would result in less upper airway~     obstruction, we evaluated the occurrence of upper airway collapse or the requirement of~     airway intervention in patients with obstructive sleep apnea during dexmedetomidine or~     propofol sedation.~   "
4855|NCT02993679|"~     The objective of this randomised cohort study was to evaluate the knee rotational stability~     after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and~     to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when~     the ALL is necessary to reconstruct.~   "
4856|NCT02993666|"~     This study is conducted to evaluate the effectiveness of forced air warming using upper and~     lower body blankets by measuring core body temperature in patients undergoing video-assisted~     thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.~   "
4857|NCT02993653|"~     Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with~     intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial~   "
4858|NCT02993640|"~     The purpose of this study is to determine if vasopressin and nitroglycerin in combination~     will affect hepatic hemodynamics, in the setting of liver surgery.~   "
4859|NCT02993627|"~     In this double-blind Randomized Controlled Clinical Trial investigators are going to study~     the effects of Spirulina supplementation on anthropometric measurements, lipid profile,~     appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or~     obese adults.~   "
4860|NCT02993614|"~     This is a comparative effectiveness study comparing new users of SGLT-2 inhibitors with new~     users of other glucose lowering drugs with regard to hospitalization for heart failure and~     all cause mortality respectively. The study is carried out based on data from six countries:~     Unites States, United Kingdom, Germany, Sweden, Denmark and Norway~   "
4861|NCT02993601|"~     The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering~     from heart failure, who have peripheral oedema. The device is non-contact and does not~     requires patient compliance to work. It gives an output reading of the patient's lower leg~     volume.~      During the study, this measurement will be compared to clinical standard and gold standard~     measurements as well as clinical grading of peripheral oedema.~   "
4862|NCT02993588|"~     The purpose of this study is to investigate the impact of melatonin administration on in~     vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes~     and embryos in the prospective poor responders.~   "
4863|NCT02993575|"~     The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared~     to non-ICU patients. The investigators will determine total and free flucloxacillin~     concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion~     (n=20) of flucloxacillin as standard care.~      Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing~     regimen and limited sampling will be taken for individual patients on the continuous dosing~     regimen on day 2 and 4.~   "
4864|NCT02993562|"~     This project has the following primary aims:~      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients~     during the first six months after starting levothyroxine (L-T4) substitution therapy~      Secondary aims are:~      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body~     mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut~     and pancreatic hormone responses, gastric and gall bladder emptying, resting energy~     expenditure (REE), quality of life (QOL) and cognitive function~   "
4865|NCT02993549|"~     Head injury is a common and devastating condition that can affect people at any stage of~     their lives. The treatment of severe head injury takes place in intensive care where~     interventions are designed to protect the brain from further injury and provide the best~     environment for recovery. A number of different monitors are used after head injury,~     including a monitor called microdialysis, to measure how the brain is generating energy.~     Abnormalities in these monitors guide doctors to the right treatments when the brain is at~     risk of further injury. There are lots of ways that the brain can be injured further after~     head injury such as raised pressure in the skull from brain swelling, low oxygen levels and~     low glucose levels. In this study we aim to combine information from all of these monitors~     to figure out what the underlying problem is and choose the right intervention to treat the~     problem that is affecting the patient at the time and compare this with previous treatment~     protocols to see if it improved outcome.~      Aim:~      To establish and validate a protocol to treat abnormalities in a microdialysis measure~     called lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and~     compare it with patient cohorts not being monitored using the current protocol.~   "
4866|NCT02993536|"~     The purpose of the study is to assess the evolution of B cells at a genetic and~     surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted~     population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will~     include patients with relapsed or refractory disease who require therapy with idelalisib and~     rituximab as per FDA label. This is an observational study for peripheral blood samples of~     these patients collected at pre-determined time points.~   "
4867|NCT02993523|"~     Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white~     blood cell responsible for fighting infections). Successful treatment of AML is dependent on~     what subtype of AML the patient has, and the age of the patient when diagnosed.~      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a~     cell) that allows cancer cells to stay alive. This study is designed to see if adding~     venetoclax to azacitidine works better than azacitidine on its own.~      This is a Phase 3, randomized, double-blind (treatment is unknown to patients and doctors)~     study in patients with AML who are 60 or more years old and have not been treated before.~     Patients who take part in this study should not be suitable for standard induction therapy~     (usual starting treatment). AbbVie is funding this study which will take place at~     approximately 150 hospitals globally and enrol approximately 400 patients.~      In this study, 2/3 of patients will receive venetoclax every day with azacitidine and the~     remaining 1/3 will receive placebo (dummy) tablets with azacitidine.~      Patients will continue to have study visits and receive treatment for as long as they are~     having a clinical benefit. The effect of the treatment on AML will be checked by taking~     blood, bone marrow, scans, measuring side effects and by completing health questionnaires.~     Blood and bone marrow tests will be completed to see why some people respond better than~     others. Additional blood tests will be completed for genetic factors and to see how long the~     drug remains in the body.~   "
20348|NCT02790853|"~     The goal of this clinical research study is to learn if new types of imaging devices can~     help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.~   "
4870|NCT02993484|"~     The overall aim of this study is to examine the role of mitochondrial respiration in human~     diabetic tissue before and after ischemia. Furthermore we will examine the ability of~     ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic~     performance of both non-diabetic and diabetic fibers after ischemia. To increase our~     understanding on the metabolic changes during ischemia in both non-diabetic and diabetic~     tissue we will use Dimethyl Malonate and examine the impact of this blockade on~     post-ischemic mitochondrial respiration.~   "
4871|NCT02993471|"~     This study is known as a drug interaction study. The purpose is to learn about how~     ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine,~     omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome~     P450. Each participant will complete two study periods. Participants will take the mixture~     of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with~     ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about~     17 weeks, including follow-up. Screening must be completed prior to study start.~   "
4872|NCT02993458|"~     The Camp DASH study trial will compare the effect of two dietary patterns and two levels of~     sodium intake on blood pressure and blood lipids in adolescents in the upper third of~     distribution for blood pressure. The two dietary patterns are based on the Dietary~     Approaches to Stop Hypertension (DASH) trial in adults.~   "
4873|NCT02993445|"~     The purpose of this study is to evaluate the effect of complementary and alternative~     therapies, specifically alternate nostril breathing and foot reflexology, on intraocular~     pressure in patients with ocular hypertension.~   "
4874|NCT02993432|"~     It is currently unknown if there is a way to decrease the risk of cesarean delivery when~     undergoing cervical ripening and induction of labour. Some research suggests a Foley~     catheter placed through the cervix and filled to 80cc may decrease this risk. We wish to run~     a large scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section~     compared to the commonly used medication for cervical ripening, prostaglandins. Before we~     can undertake a large trial, we need to do a pilot to see if women will agree to participate~     in this type of study. As well, a pilot will help with trouble shooting prior to a large~     trail, to improve the chances of successfully answering this clinically important question.~   "
4875|NCT02993419|"~     This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study,~     into the group of children in the hospital that use clinical antibiotics from one month to~     three years old，by observing the given antibiotics at the same time with the whole bowel raw~     or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole~     bowel prevention clinical efficacy and safety of AAD.~   "
4876|NCT02993406|"~     The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus~     placebo decreases the risk of cardiovascular events in patients who are statin intolerant.~   "
4877|NCT02993393|"~     Abstract Background and Goal of study Teaching and learning in airway management are~     essential in anesthetic field. Though simulation-based and problem-based learning are~     sophisticated learning tool, neither of them manifests the superior benefit. We would like~     to compare the teachers' and students' attitudes on these two learning methods.~      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,~     questionnaires-based study was performed amongst volunteered, consent-signed, 10~     anesthesiologists and 40 nurse anesthetist students. After stratified randomization, ten~     students simultaneously attended either SBL or PBL course one at a time. Six weeks later, a~     crossover technique was applied for both groups. At the end of project, teachers and~     students had to response to Likert's scale questionnaires.~      The teachers' questionnaire based on table of specification of the learning contents,~     consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow~     up care. The students' questionnaire comprised 3 parts: learning content, process and~     evaluation.~      The validation of the questionnaire was determined by three board-certified~     anesthesiologists. The index of item objective congruence was 0.80 and 0.82 with Cronbach's~     Alpha of 0.97 and 0.92 respectively.~   "
4878|NCT02993380|"~     Patients with chronic kidney disease (CKD) have higher mortality rate than general~     population. Especially, the most common cause of mortality was known as cardiovascular~     disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was~     reported for lowering risk of coronary artery disease in general population. Mediterranean~     diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and~     protein.~      Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many~     researchers usually preferred olive oil as control group for evaluating effect of omega-3~     fatty acid. However, previous studies reported that control groups using olive oil of 3g in~     a day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid~     (EPA) or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be~     associated with increasing of omega-3 fatty acid levels.~   "
4879|NCT02993367|"~     Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to~     progress to dementia, but there have been no proper large-scale intervention trials~     dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter,~     subcortical VCIND) represents a relatively homogeneous disease process and is a suitable~     target for therapeutic trials investigating VCIND. Preclinical trials showed that~     Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In~     this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study~     the effects of Butylphthalide Soft Capsules in patients with VCIND.~   "
4880|NCT02993354|"~     The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be~     reliable as a non-invasive method for evaluating uterine contractions and the fetal heart~     rate. It is safe and effective in monitoring uterine contractions. The investigators propose~     to perform a series of studies to validate the accuracy and clinical usefulness of the EUM~     device by simultaneously monitoring patients with current methods (with either external or~     internal devices) as clinically indicated and with the EUM device. Providers will be blinded~     to the results of the EUM device. The investigators will continue care as per current~     guidelines using the information obtained from the current monitoring methods. Information~     obtained from the EUM devices will not be used to determine the clinical course of action.~   "
25859|NCT02718677|"~     This NIS aims to evaluate the efficacy and the safety of ReFacto AF in the Standard~     Prophylaxis Treatment of children with severe hemophilia A in Romania~   "
4881|NCT02993341|"~     Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical~     benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication~     with low complication risk. Its use in the hip fracture population is unproven. The purpose~     of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction~     of peri-operative blood loss in hip fracture surgery.~   "
4882|NCT02993328|"~     This trial will be a double-blind, single-center, randomized, placebo controlled study to~     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for~     up to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of~     mild-to-moderate plaque psoriasis.~   "
4883|NCT02993315|"~     The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after~     complete radical lymph node dissection in stage IIIB and IIIC melanoma patients, improves~     recurrence-free survival (RFS) as compared to treatment with matching placebo.~   "
4884|NCT02993302|"~     Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating~     autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in~     healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro~     1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral~     1α-D3 on DC maturation in GD patients.~   "
4885|NCT02993289|"~     Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to~     European guidelines and based on evidence, multidisciplinary detoxification is the first~     choice of treatment for MOH. However, consensus about the details in such detoxification~     programs is lacking. Contrary, other headache specialists believe more in treating chronic~     headache with medication overuse with single-therapy of prophylaxis and no withdrawal of~     acute medication, based on randomized controlled double-blinded placebo trial with~     prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to~     detoxification. However there was no significant difference.~      AIM:~        1. To compare three different treatment protocols in order to improve the therapy of MOH.~        2. To test several baseline variables for being potential predictors for good treatment~          outcome.~        3. To examine the role of epigenetics in MOH.~   "
4886|NCT02993276|"~     This post-market surveillance study is conducted to provide post market surveillance~     information regarding long-term performance and ease of use of the Polyganics nerve capping~     device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.~   "
4887|NCT02993263|"~     The investigators propose to estimate the sensitivity and specificity of the VectraplexECG~     System for detecting acute myocardial ischemic injury, including acute myocardial~     infarctions after major non-cardiac surgery.~      A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the~     post-anesthesia care unit.~      On the first, second and third post operative morning a 10 second CEB dynamic sequence will~     be recorded. Blood will be sampled for troponin as well.~      On the first, second and third post operative afternoons a 10 second CEB dynamic sequence~     will be recorded.~      The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long~     as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will~     continue as long as the patient remains hospitalized.~   "
4888|NCT02993250|"~     The main purpose of this study is to evaluate the safety and tolerability of a combination~     treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese~     participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection with or without~     compensated cirrhosis who are direct-acting antiviral (DAA) naive.~   "
4889|NCT02993237|"~     The primary purpose of this study is to assess the acceptability of swallowing the~     darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide~     (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human~     immunodeficiency virus (HIV) -1 infected adolescent patients.~   "
4890|NCT02993224|"~     Study to evaluate patient preference of deferasirox FCT or deferasirox DT in patient with~     transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by~     preference questionnaire at Week 48~   "
4891|NCT02993211|"~     Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a~     piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate~     surgical technique in bladder tumour resection. By preventing tumour fragmentation and~     ascertaining complete tumour resection by histological assessment of the EBR specimen, we~     hypothesized that EBR could reduce disease recurrence as compared to SR.~   "
4892|NCT02993198|"~     The Cardio-Oncology program at Northwestern offers care to cancer patients who develop~     cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2~     necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based~     chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will~     undergo a cardio-oncology echocardiogram which incorporates advanced left ventricular~     assessment by utilizing deformation or strain imaging during chemotherapy treatment for~     surveillance of cardiac toxicities. The aims of this project are:~        1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and~          genetic analysis that will be used to develop a risk model to predict LV dysfunction in~          early stage breast cancer patients undergoing chemotherapy with anthracycline and/or~          trastuzumab and pertuzumab-based chemotherapy regimens.~        2. To propose a new management algorithm for initiation of prophylactic beta-blocker~          therapy for early stage breast cancer patients with preclinical cardiac toxicities~          demonstrated by strain parameters.~        3. To determine if initiation of prophylactic beta-blocker therapy in patients with early~          cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical~          heart failure.~        4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer~          treatment that are presumed but not yet proven to be predictive of cardiac dysfunction~          in women with breast cancer.~        5. To identify DNA biomarkers of predilection to cardiotoxicity.~        6. To generate hiPSC to validate markers predictive of cardiotoxicity.~   "
4893|NCT02993185|"~     The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual~     health education program, Your Move (YM) against a nutrition control program, Eat Smart~     (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual~     decisions with the ultimate goal of reducing unplanned pregnancies and STIs.~   "
4894|NCT02993172|"~     The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in~     1976 which has examined approximately 25,000 individuals from the general population. The~     initial sample has been re-invited up to four times and supplemented by younger individuals.~     The study includes questionnaires, clinical assessment and biomarkers. The population have~     been followed in a number of outcome registries and more than 900 scientific papers have~     been published.~   "
4895|NCT02993159|"~     This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating~     patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast~     cancer by blocking the use of estrogen by the tumor cells.~   "
4896|NCT02993146|"~     This phase I trial studies the side effects and best dose of ropidoxuridine when given~     together with whole brain radiation therapy in treating patients with cancer that has spread~     to the brain. Ropidoxuridine may help whole brain radiation therapy work better by making~     cancer cells more sensitive to the radiation therapy.~   "
4897|NCT02993133|"~     The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus~     is an autoimmune dermatological disease characterized by the production of anti-desmoclesin~     antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an~     autoimmune dermatological disease, characterized by the production of anti-zone antibodies~     of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic~     acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use,~     pharmacokinetics in autoimmune bullous dermatosis remain little studied.~   "
4898|NCT02993120|"~     This is a multicenter observational cohort study with both retrospective and prospective~     data collection components in subjects with ASCVD.~      The purpose of this study is to better understand cholesterol treatment patterns in the~     context of a changing landscape in subjects with ASCVD.~   "
4899|NCT02993107|"~     The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101~     through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children~     and adults who have completed the ARC003 study.~   "
4900|NCT02993094|"~     This is an open-label phase I/II study for patients with advanced (locally advanced~     inoperable or metastatic) triple-negative breast cancer progressing after first-line therapy~     receiving ixazomib on days 1, 8, and 15 in combination with carboplatin on days 1, 8, and~     15. Cycles will be repeated every four weeks.~   "
4901|NCT02993081|"~     Study of refractive changes after capsulotomy with YAG laser in facectomized patients.~   "
4902|NCT02993068|"~     The goal of this research study is to test the effects of online genetic education alone or~     in combination with telephone genetic counseling in order to compare the two methods and the~     stress a person feels about their risk of cancer.~      Researchers also want to learn how these strategies may improve participant's understanding~     of genetics, participant's ability to complete a quiz about genetics, and participant's~     quality of life.~   "
4903|NCT02993055|"~     A Phase I dose escalation study involving healthy subjects.~   "
4904|NCT02993042|"~     Robot-assisted gait training can improve gait ability of patients with Parkinson's disease~     by repeating a normal gait pattern with high intensity. This study is a feasibility study to~     investigate whether robot-assisted gait training can be applied to improve walking autonomy~     in patients with Parkinson 's disease.~   "
4905|NCT02993029|"~     Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has~     received growing attention in the society because of the increase of old age population,~     disabled people, and medical expenses from this disease. 99Tc-MDP is effective for~     rheumatoid arthritis. Therefore, the investigators try to investigate the effects of~     99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.~   "
4906|NCT02993016|"~     Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving~     function. However, in instances where incorrect positioning and malignment of the TKA~     components are observed, patients can experience a range of negative postoperative outcomes~     such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant~     loosening, and eventual early revision. To avoid these complications, achieving a~     postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.~     Manual intramedullary/extramedullary guides are not thought to be capable of consistently~     achieving axes in this range, and though computer-assisted navigation has shown superior~     results in comparison with conventional instrumentation, it is also limited by increased~     surgical times and no clear superiority in improving short-term clinical outcomes. Thus,~     there has been in a push in the orthopaedic community to create more precise technologies to~     aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation~     (PSI), which uses anatomical data obtained primarily from pre-operative axial computed~     tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs~     individualized to the patient's unique anatomy, was created with this goal.~      This study aims to compare the clinical results of conventional and patient-specific~     instruments in total knee arthroplasty.~   "
4907|NCT02993003|"~     Core temperature is of greatest interest in terms of temperature monitoring as it is thought~     to represent the temperature of the vessel-rich groups that are instrumental in~     thermoregulatory control. The nasopharynx is among the recommended temperature monitoring~     sites for core body temperature. It is the part of the pharynx that lies above the soft~     palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it~     communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures~     are accurate in adults when probes are inserted between 10 and 20 cm.~      The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants~     and children. While some data suggest that anthropometric measurements are well correlated~     with endoscopic measurements in infants based on weight, the accuracy of temperature~     measurements at these and other distances has yet to be quantified. The investigators thus~     propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature~     proves that best approximate core temperature as measured in the distal esophagus in infants~     and children of various sizes. The comparison site will be the distal esophagus since there~     is broad consensus that the distal third of the esophagus it at core-body temperature.~      For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be~     marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two~     groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with~     indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a~     nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments~     from its tip, and inserted 20 cm.~      Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after~     induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated~     increment for each age group and will be equilibrated for 5 minutes before the temperature~     is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number~     of measurement will depend on the initial depth of insertion, with measurements continuing~     until only 2 centimeters remain in the nostril.~   "
20403|NCT02790125|"~     The primary purpose of this study is to determine if single doses of BMS-986166 are safe and~     well tolerated in healthy male subjects and female subjects of non-childbearing potential.~   "
4909|NCT02992977|"~     This is an open-label Phase 1 study to determine the safety, feasibility, and tolerability~     of single-agent treatment with AutoSynVax™ vaccine in subjects with advanced cancer and a~     life expectancy of ≥6 months. A minimum of 6 (≤20) subjects will be enrolled to receive~     biweekly subcutaneous injection of 240 μg AutoSynVax™ vaccine + 50 μg QS-21 Stimulon®~     adjuvant for up to 1 year.~   "
4910|NCT02992964|"~     This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric~     patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of~     age. This study is to assess clinical and radiological benefits of treatment with Nivolumab~     in children with hypermutated cancers, including those with bMMRD syndrome. It is our~     expectation that patients with bMMRD syndrome will account for the majority of patients~     enrolled on this study.~   "
4911|NCT02992951|"~     Surgical site infection is an infection at a place in the body where surgery has taken~     place, and has been reported in around 5% of people undergoing an operation. In vascular~     surgery, infection rates are as high as 30%. Methods to reduce this rate of infection should~     be investigated thoroughly for their effectiveness and cost-effectiveness.~      The investigators aim to conduct a research trial examining one such method. Leukomed~     Sorbact is a wound dressing coated with a chemical (DACC) derived from spider-silk that~     interacts with, and binds bacteria, causing them to be mechanically removed from a wound~     when the dressing is changed.The trial aims to compare the effectiveness of this dressing to~     a standard, non-coated dressing, in the reduction of surgical site infection.~      712 patients from a number of centres across the UK will be recruited to this study. Adult~     patients who are having a vascular surgery operation will be approached for entry into the~     trial. The trial will be explained to them, as well as an explanation that participation is~     voluntary and their operation or other aspects of their care will not be impacted in any way~     should participants not wish to participate.~      Participants will be randomised by computer into one of two groups - one group whose wounds~     are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard~     dressing. Patients will be followed up at 5-7 days and 30 days, and at 1 year. At the follow~     up, their wounds will be inspected for infection, and participants will be asked to complete~     short questionnaires measuring quality of life.~      The trial will aim to answer a number of questions, with the primary question being does a~     DACC coated dressing applied after an operation reduce the risk of an infection at the~     surgery site? It will also ask whether this treatment is cost-effective and whether it~     promotes satisfactory healing.~   "
4912|NCT02992938|"~     Remifentanil is a potent opioid widely used during the administration of general anesthesia.~     There is a lot of evidence that suggest that the used of remifentanil is associated with the~     development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism~     of this hyperalgesia is not fully understood.~      Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved.~     Interestingly, this was prevented in a murine model with the administration of~     Acetazolamide, a carbonic anhydrase inhibitor. In our clinical trial we will try to~     determine if the preoperative administration of acetazolamide could prevent the hyperalgesia~     induced by remifentanil in patients scheduled for thyroidectomy with general anesthesia.~   "
4913|NCT02992925|"~     The purpose of this study is to:~        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of~          BK1310.~        -  (cohort 2) evaluate efficacy of BK1310 for all antigens (anti-PRP, diphtheria toxin,~          pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared~          noninferiority with co-administration of ActHIB® and Tetrabik, as well as safety, in~          healthy infants.~   "
4914|NCT02992912|"~     Although it is usually described as an immunosuppressive modality and not thought of as~     immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing~     irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity,~     which enhances tumour control both locally and distantly. Importantly, IR effects exceed the~     classical cytocidal properties by also causing phenotypic changes in the fraction of~     surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination.~     However, not all IR-induced modifications of the tumour and its microenvironment favor~     immune rejection. The tumour microenvironment is populated by various types of inhibitory~     immune cells including Tregs, alternatively activated macrophages, and myeloid-derived~     suppression cells (MDSCs), which suppress T cell activation and promote tumour outgrowth.~     Chiang et al. showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia~     present in irradiated tumours. IR then may also induced responses that are inadequate to~     maintain antitumuor immunity.~      Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for~     the rational design of combination therapy with immune modulators and radiotherapy. Deng et~     al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR.~     Moreover, administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T~     cell-dependent mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1~     synergistically reduced the local accumulation of tumour-infiltrating MDSCs, which suppress~     T cells and alter the tumour immune microenvironment. Finally, activation of cytotoxic T~     cells with combination therapy mediated the reduction of MDSCs in tumours through the~     cytotoxic actions of TNF. Sagiv-Barfi et al, also demonstrated in 5 patients receiving~     atezolizumab and radiation therapy, at least stabilization of systemic progression in all~     patients and a RECIST partial response at systemic sites in 1 patient. Transient, grade 1-2~     inflammatory adverse events (fevers, flu-like symptoms) occurred with no serious~     immune-related toxicities. Abscopal out-field effects of irradiation has also been described~     in addition to a reduction in circulating MDSCs in a melanoma patient treated with the anti~     CTLA-4 ipilimumab and radiotherapy.~      Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic~     ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for~     patients with solid tumour, with durable remissions and a low toxicity profile. Many~     non-randomised studies have shown that SBRT for oligometastases is safe and effective, with~     local control rates of about 80%. Importantly, these studies also suggest that the natural~     history of the disease is changing, with 2-5 year progression-free survival of about 20%.~     For colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates~     ranged from 67 to 91%. The goal of SABR is to deliver appropriate metastasis directed~     radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly, the~     dose and fractionation employed modulate RT ability to synergize with immunotherapy.~     Vanpouille-Box et al, showed that immune response genes were differentially expressed in~     irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated~     SABR acting as a in situ tumour vaccine.~      As hypofractionated SABR may, in addition to its good local control, increase the~     effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the~     tolerability of the combination of anti-PD-L1 antibody with SABR.~   "
4915|NCT02992899|"~     The tasks of the project are to map the potency and kinetics of the neurologic, autonomic~     peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham~     treatment, at baseline and in response to stressful traumatic scripts related to personal~     traumatic events, as well as a series of other stressors.~   "
4916|NCT02992886|"~     The aim of this multicenter phase II study is to evaluate the response rate, local control,~     disease-free survival and treatment-related toxicity of preoperative chemoradiation for~     intermediate or locally advanced rectal cancer in the fit elderly.~   "
4917|NCT02992873|"~     Sudden cardiac death is a major health problem in the western world. In Europe alone nearly~     300 000 patients are affected annually. The majority of victims suffering from an~     Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by~     means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is~     too long and survival averages 10 %.However, when laymen operated Automated External~     Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.~      The aim of The Scandinavian AED and Mobile Bystander Activation (SAMBA) trial is to~     evaluate if a Mobile Phone Positioning system and a smartphone application will increase the~     proportions of patients with an attached Automated External Defibrillator (AED) before~     arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone~     application will be used identify and recruit nearby CPR-trained lay people and automated~     external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA).~     The system is currently running in Stockholm Sweden and in the Gothenburg region.~   "
4918|NCT02992860|"~     The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5~     months after failure, representing a significant unmet medical need due to the very limited~     treatment options. In this context, a specific targeting of the leukemic stem cell (LSC)~     seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123~     is overexpressed in AML and MDS progenitors making it an attractive target for~     immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been~     engineered with regard to this strategy and the current phase II trial has the aim to~     evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML~     and MDS patients.~   "
4919|NCT02992847|"~     Several recent studies have shown an increase in the signal intensity of the unenhanced~     T1-weighted magnetic resonance images in the brain of patients with normal renal functions~     and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to~     an accumulation of gadolinium based contrast agent. These studies were mainly conducted in~     patients with primary or secondary brain tumor. Multiple sclerosis is a particular model~     since it involves patients with a break of the blood-brain barrier, a long life expectancy,~     and who received many injections of contrast enhancing agents. In this context, it appears~     fundamental to know whether contrast agents accumulate in the brain for this disease. The~     French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis,~     with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1~     without injection. The purpose of this study is to evaluate the accumulation of two commonly~     used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple~     sclerosis, who received at least 5 injection of exclusively one of these contrast material.~   "
4921|NCT02992821|"~     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))~     it is important to reveal the underlying cause of the disease. In special it is important to~     reveal if carotid artery stenosis is present as such a finding will directly influence on~     treatment and follow-up.~      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations~     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in~     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for~     semi quantitatively bed-side assessment of the carotid arteries and the heart.~      The investigators aim to study the feasibility and reliability of bed-side assessment of the~     carotid arteries by pocket-sized ultrasound scanners in inexperienced hands and the clinical~     influence of this examination when performed by experienced users.~      The investigators hypothesize that a significant proportion of this patient population can~     be clarified bed-side by junior doctors with no need of further imaging procedures for the~     assessment of the carotid arteries and the heart.~   "
4922|NCT02992808|"~     In this study the investigators will try to discover whether there is a difference for any~     of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris)~     vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of~     androgenic hormones profile. The study question is whether using recombinant LH will result~     in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using~     highly purified urinary gonadotropins with hCG mimicking LH activity.~   "
4923|NCT02992795|"~     This is a prospective, non-blinded, matched control study of young athletes (ages 10-28~     years old) in collegiate sports. The cohorts are defined in accordance to the athlete's~     exposure of injury. All subjects will complete a minimum of one recording based on their~     assigned cohort. Concussed athletes will complete an additional 3 weeks of follow-up~     recordings post injury. The symptomatic evaluation, physical examination, neurological~     baseline testing, and BrainPulse recordings will be entered in a database to determine~     clinical outcome and assess device utilization.~   "
4924|NCT02992782|"~     Women who have undergone breast cancer surgery may develop swelling of the arm on the side~     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This~     study will examine the effect of a 12-week decongestive progressive resistance exercise with~     advanced compression on breast cancer related lymphedema. Our objective is to determine if~     breast cancer survivors are willing and able to wear advanced compression while exercising~     and if the combination will help to reduce their lymphedema. Twenty-four breast cancer~     survivors from Edmonton, Alberta will be enrolled in the one-year long study.~   "
4925|NCT02992769|"~     Axillary lymph node status is a vital prognostic factors in breast cancer patients and~     provides crucial information for making treatment decisions.This projective observational~     study is planned to identify risk factors for axillary metastases in breast cancer patients~     with axillary ultrasound and to construct a nomogram to predict the risk of axillary~     metastases in these patients.~   "
4926|NCT02992756|"~     Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:~     after at least one cycle of stimulation obtaining 0-4 oocytes.~      Improve the follicular response in patients with low response, increasing the number of~     follicles in subsequent cycles to treatment with growth factors.~   "
4927|NCT02992743|"~     This study is for men and women who have a type of sarcoma that has returned after being~     treated, or that cannot be surgically removed. The specific type of sarcoma is Myxoid /~     Round Cell Liposarcoma, also known as High Grade Myxoid Liposarcoma.~      In addition to this disease patients must also have the tissue type HLA-A*02:01, HLA-A*02:05~     or HLA-A*02:06, and a sample of tumor tissue must test positive for the NY-ESO-1 protein.~      The study treatment is made from some of the patient's own white blood cells called T cells.~     T cells are collected from the patient and sent to a laboratory to be genetically modified,~     with the aim that they will be able to destroy the cancer cells.~      Manufacturing the T cells takes about 1 month to complete. The T cells will be given back to~     the patient by an intravenous infusion. The purpose of this study is to test whether the T~     cells have an effect on the cancer and to test whether the treatment can be given safely to~     patients with this disease.~   "
4928|NCT02992730|"~     Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.~     Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer~     deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive~     tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,~     this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are~     more likely to die from their breast cancer as ER positive White women. Preliminary data~     suggest that non-adherence to adjuvant hormonal therapy could explain some of this~     disparity. To date, no study has systematically examined psychosocial, healthcare, and~     biological factors that predict adherence to hormonal therapy in Black women with breast~     cancer. To begin to fill this knowledge gap, Investigators will conduct a prospective cohort~     study of 422 ER positive Black breast cancer patients recruited from health maintenance~     organizations (HMOs). Our primary outcome is adherence to therapy at 36 months post~     initiation. Specific aims are to: 1) Examine psychosocial factors (e.g. health beliefs,~     socio-cultural values, etc.) that predict adherence to hormonal therapy; 2) Identify~     clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict~     adherence to hormonal therapy; and 3) Evaluate healthcare variables (e.g., communication,~     management of side effects, etc.) that predict adherence. Investigators will also explore~     the role of CYP2D6 genetic variations in adherence to hormonal therapy which is novel and~     will increase knowledge about this genetic factor in Blacks. The study is focused on the~     time-period (first 3 years) when women appear to be the most vulnerable to terminating~     treatment prematurely. A better understanding of predictors of adherence in Black women may~     help target interventions and ultimately improve potentially avoidable adverse breast cancer~     outcomes in this underserved group.~   "
4929|NCT02992717|"~     The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined~     Delirium. The primary objective of this study is to translate the 3D-CAM into the German~     language, as well as to validate its use to detect postoperative delirium in the recovery~     room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening~     Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical~     Manual of Mental Disorders).~   "
4953|NCT02992405|"~     The FOCUS program (study treatment) is an established evidence-based intervention whose~     redesign for families and couples dealing with serious and chronic illnesses will provide a~     creative and promising supplement to the existing support services at Cedars-Sinai Medical~     Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but~     will be split into two groups, the immediate treatment group and the wait list treatment~     group, who will receive the study treatment after the immediate 10 weeks of treatment is~     completed.~   "
25860|NCT02718664|"~     Healthy volunteer food-effect study to determine the effect of food on uracil and~     dihydrouracil levels in plasma~   "
4930|NCT02992704|"~     Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not~     recommended to be treated by guidelines as they are at low risk for complications. However,~     it is unclear if treatment can enhance HBsAg loss which has been shown to be associated with~     significantly lower risk of complications compared to those without HBsAg loss.~     Consequently, this is a proof of concept study to determine the possibility of HBsAg loss in~     Chronic Hepatitis B carriers in a randomised open label clinical trial comparing no~     treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised~     1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of~     therapy for those on therapy and matched to an equivalent timepoint in the control arm. The~     sample size calculation is 30 patients in each arm for a 20% difference between any~     experimental arm and the control arm.~   "
4931|NCT02992691|"~     The Dose response of three experimental toothpastes (test product 1, test product 2 and test~     product 3) to remove plaque after a single brushing, compared to a positive control and~     negative control dentifrice will be evaluated.~   "
4932|NCT02992678|"~     Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are~     scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be~     recruited for the study. Patients were randomized using opaque, sealed envelopes containing~     random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo~     (placebo group) for preventing ERCP pancreatitis.~   "
4933|NCT02992665|"~     The purpose of this study is to determine the impact of the use of calcium ionophore on the~     ICSI outcomes in couples with severe male factor infertility. Investigators conduct a~     randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in~     these cases.~   "
4934|NCT02992652|"~     -  The investigators evaluated the role of allopurinol in prevention of post-ERCP~          pancreatitis.~        -  100 Egyptian patients who were candidates for ERCP were included and divided into two~          groups. Group 1 (study group) included 50 patients who received two doses of~          allopurinol 300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group)~          included 50 patients who did not receive allopurinol prophylaxis.~   "
4935|NCT02992639|"~     To investigate weight loss effect with mild calorie restriction on circulating levels of~     liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral~     fat area (VFA) at L4 ≥ 100 cm²].~   "
4936|NCT02992626|"~     In a randomised controlled cross-over study, the influence of interacting with a dog on~     children's learning performance is investigated.~   "
4937|NCT02992613|"~     Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)~     total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee~     arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty~     has been postulated to provide reproducible femoral rollback and increased flexion. However,~     posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to~     several post-cam related problems, including post-cam dislocation, wear and breakage of~     post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone~     resection and poses a risk for intercondylar fracture of the distal femur during box~     preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent~     (UC) total knee arthroplasty was introduced.~      This study aims to compare the clinical results of Ultra-Congruent(UC) and~     posterior-stabilized(PS) insert in bilateral total knee arthroplasty.~   "
4938|NCT02992600|"~     To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction~     and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a~     predictor of POCD and to provide reference for POCD prevention, early detection and timely~     diagnosis and treatment.~   "
4939|NCT02992587|"~     Background:~      Over the past decades there have been seen an increase in life expectancy in Denmark. One of~     the consequences is that the patients who need heart surgery have a higher average age and~     some of these patients have a fragile physique that increases the risks of major surgery.~      In cardiac surgery, there are different types of scoring system for assessing the~     preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems~     the most used.~      This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive~     assessment of frailty), based on an assessment of the patient's physical condition. If the~     patient has a lower than expected physical condition, the patient is frail. The assessment~     of the physical condition generated from questions about the patient's medical history and~     physical activity as well as performing less physical tests, consisting of strength, balance~     and walking speed.~      Purpose:~      A prospective observational study, who investigates how many of the patients who must~     undergo heart surgery, that is frail. Then compare the patients who are frail with non-frail~     patients in terms of complications, mortality and quality of life after the procedure. By~     use of CAF score the patients are scored frail or non-frail. There is planned a further~     study which compare degree of kidney injury in frail with non-frail patients. Our assumption~     is that patients which are frail, have an increased risk of complications and longer~     hospital stay, higher consumption of intensive days and more readmissions. Using frailty~     score in combination with the existing score systems EuroSCORE and STS score, are believed~     to be a better predictor of complications following heart surgery.~      Method:~      FICS study is a prospective observational study of patients undergoing cardiac surgery in~     the cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two~     year period. The study consists of various smaller physical test and questions. Which is~     used to assess whether the patient is frail and not frail.~      Postoperatively follow-up after 30 days with a phone call and after 12 months through danish~     data register. At the both follow-up times, data are collected on the somatic readmissions /~     diagnoses and vital status through the national register and review of relevant journal~     notes. Afterwards comparing complications and mortality.~      Who can enter:~      One patients can be included if the following criteria are met: Age> 65 years, Elective or~     subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination~     of these~      If one or more of the following criteria are met, the patient is not included in the study:~      Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative~     (psychiatric diagnosis) and Re-operations.~      Side effects, risks and disadvantages:~      Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty~     score will not expose patients to the risk or side effect, since the course or treatment~     does not change.~      Economy:~      There are considered that the study are economically justified, since hypothetically this~     would lead to fewer readmissions, fewer days in intensive care and shorter hospital.~      Acquisition:~      The patients will in this trial be over 65 years old and must have completed elective or~     subacute cardiac surgery. They will receive participant information and thus the opportunity~     to read about the study before the first appearance.~      At first appearance they meet our project assistant and get here verbal information about~     the study, where also questions can be answered. Subsequently, the patients will be asked to~     sign a consent form.~      Publication of test results / research ethics statement:~      The knowledge and results obtained through the survey will provide essential scientific~     information of significance for the future course and treatment of patients undergoing~     cardiac surgery with regard to the number of hospital days, intensive days and readmissions.~     Thus, the investigator believes that the study is appropriate and ethically~   "
4940|NCT02992574|"~     Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences~     as well as improving survival in node positive breast cancer patients. PMRT for women with~     T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed~     low risk of recurrence in this population as a whole. However, in the setting of multiple~     adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the~     risk of recurrence documented for patients with one to three positive lymph nodes. Numerous~     retrospective series have reported the outcome and patterns of failure for post-mastectomy~     patients treated without radiation. Many of these series have analyzed several high risk~     factors which were predictive of loco-regional recurrence wherein the role of adjuvant~     post-mastectomy radiation can be considered. Some authors have used combinations of~     prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and~     lympho-vascular space invasion to define subgroups with more specific risks of loco-regional~     recurrence than single factors alone. The current trial hypothesizes that Post-mastectomy~     radiation in high risk, node negative early breast cancer patients decreases rates of~     loco-regional recurrence and improves disease free survival and propose to address the~     question in randomized setting.~   "
4941|NCT02992561|"~     Heightened levels of aggression are fuelling violent incidents at all levels, especially in~     post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)~     aims to address trauma symptoms along with reactive and instrumental/appetitive aggression~     to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration~     into civil life. In the present study, the investigators provide an adapted version of~     FORNET to former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and~     6 month follow up interviews will be administered to assess the main outcome measures recent~     violent acts and appetitive aggression.~   "
4954|NCT02992392|"~     With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have~     been developed in which phospholipid liposomes are delivered to the tear film via the~     surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale~     Forte application on the lipid and stability of the tear film in dry eye patients.~   "
4955|NCT02992379|"~     To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw~     exercise together with stabilizing splints for treatment of TMJ anterior disc displacement~     without reduction~   "
4956|NCT02992366|"~     To evaluate the clinical and radiographic outcomes of socket shield technique compared with~     conventional immediate implant placement.~   "
4942|NCT02992548|"~     Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis~     CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of~     cardiovascular death in patients with myocardial infarction. This cardioprotective effect of~     omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic~     effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant~     properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty~     acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute~     coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also~     be related to decreased oleic acid content of erythrocyte membrane. There is no report about~     the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are~     recognized as therapeutic agents for reducing triglycerides, statin may affect on the~     erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte~     membrane FA contents including oleic acid in CKD patients.~   "
4943|NCT02992535|"~     Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment~     with IPL.~   "
4944|NCT02992522|"~     This phase I study studies the side effects and best dose of venetoclax and lenalidomide~     when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma~     that has returned after a period of improvement or not responding to treatment. Monoclonal~     antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and~     spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and~     lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.~   "
4945|NCT02992509|"~     The pilot study is intended to show the efficacy of intravesical electrical stimulation in~     treating overactive bladder with or without frequency and/or urgency urinary incontinence.~   "
4946|NCT02992496|"~     The purpose of this double-blind, controlled, randomized study is to investigate the~     antidepressant efficacy of oral ketamine treatment in patients suffering from a major~     depressive episode.~   "
4947|NCT02992483|"~     The purpose of this first in human study is to assess safety, tolerability, PK and~     preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as~     S64315) as single agent administered intravenously (i.v.) in adult patients with refractory~     or relapsed lymphoma or multiple myeloma.~   "
4948|NCT02992470|"~     This study aimed to observe whether a hydrolyzed oyster extract improves liver health in~     participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total~     of 96 participants will be randomly allocated to active (oyster) or placebo group (1:1).~     Each group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary~     outcome will be the change in ALT level and secondary outcomes will be; (1) ratios of~     participants with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl~     transferase (GGT); (2) the change in serum bilirubin; (3) the change in multi-dimensional~     fatigue inventory; (4) the changes in serum lipids; (5) the changes in antioxidant enzymes.~   "
4949|NCT02992457|"~     Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated~     nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in~     Egypt. For decades the antiviral therapy of chronic HCV infection was based on the~     administration of Interferon(IFN), initially alone and then in combination with Ribavirin~     (RBV), but this regimen was effective in only 50% of patients with genotype 1, with~     significant side effects.~   "
4950|NCT02992444|"~     This study investigates the impact real output has on peristomal skin covered by an adhesive~   "
4951|NCT02992431|"~     In the aging population, the prevalence of chronic diseases and multimorbidity has become~     common. Therefore, the planning and coordination of care have become more important.~     However, it is not known what kind of treatment plan should be and what kind of patients~     would benefit most of it.~      This research focuses on the participatory patient care planning in primary health care. In~     general, the participatory patient care planning (PPCP) aims to engage patients in~     self-care, to improve the collaboration between patients and professionals and to improve~     the use of resources. The present study investigates the feasibility and effectiveness of~     the PPCP.~      The specific research questions of the present study are: Does the PPCP have an impact on~     the patient's quality of life? Does the PPCP improve the quality of care in management of~     chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP~     impact on the use of health care services? The data consists of people aged at least 18~     years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or~     hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient~     record. The participating patients are recruited from those who contacts SiiIinjärvi Health~     Care Center in order to have a follow-up visit because of the treatment of their disease.~     This study aims to recruit 700 patients.~      The participants are allocated into the intervention group and into the control group~     receiving usual care. Intervention consists of the PPCP. This includes the patient~     activation questionnaire form, a visit to the nurse who conducts the measurements (blood~     pressure, waist measurement, weight and length) and a visit to the general practitioner who~     discusses and agrees with the patient about the treatment goals and follow-up resulting in~     the written PPCP.~      The main out-come measures are the quality of health related life measured with the 15D; the~     level of patient's activity in self-care with the Patient Activation Measurement (PAM); life~     satisfaction, self-rated health, a reduction in productivity with the Work Productivity and~     Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood~     pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain~     intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls~     and referrals are measured.~   "
4952|NCT02992418|"~     The aim of the study is investigate the immunogenicity and safety of CYD dengue vaccine and~     Tdap vaccine when both vaccines are administered concomitantly or sequentially.~      Primary Objectives:~        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster~          dose concomitantly administered with the first dose of CYD dengue vaccine as compared~          to sequential administration, measured 28 days after Tdap booster dose~        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of~          CYD dengue vaccine concomitantly administered with Tdap as compared to sequential~          administration, measured 28 days after the first dose of CYD dengue vaccine.~      Secondary Objectives:~        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD~          dengue vaccine with the first dose concomitantly administered with Tdap as compared to~          sequential administration, measured 28 days after the third dose of CYD dengue vaccine.~        -  To describe the humoral immune response at baseline and 28 days after the first and~          third doses of CYD dengue vaccine, in each and any group.~        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after~          concomitant administration with the first dose of CYD dengue vaccine as compared to the~          sequential administration, in each and any group.~        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after~          each and any injection in each group.~   "
4957|NCT02992353|"~     In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and~     39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical~     operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is~     performed in clinical operation with the aim of decreasing postoperative complications~     morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical~     injury. There are some trials regarding two-port VATS versus three-port VATS versus~     four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective~     randomised controlled trial regarding Single-port versus two-port versus three-port video~     assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that~     single-port and two-port VATS were feasible and safe through the trial, and we hope the~     results of our study will provide a high level of clinical evidence for choosing the best~     operative approach in VATS.~   "
4958|NCT02992340|"~     .The study intends to evaluate the objectives in patients with advanced or metastatic~     biliary tract cancer who have not received systemic therapy for advanced/metastatic disease.~      Primary Objectives:~      Phase 1B~      • To determine the maximum tolerated dose (MTD), as determined by dose-limiting toxicities~     (DLTs), and to characterise the safety profile of Varlitinib in combination with Gemcitabine~     and Cisplatin.~      Phase 2~      • To access the efficacy of Varlitinib in combination with Gemcitabine and Cisplatin in~     terms of objective response rate (ORR) by 24 weeks (ORR based on RECIST v1.1).~   "
4959|NCT02992327|"~     The overall research aim of this pilot study is to determine if the structural brain protein~     calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to~     accurately identify patients who will have more severe symptoms and reduced neurocognitive~     functioning after sustaining a concussion. Concussion is also referred to as mild traumatic~     brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout~     this application.~   "
4960|NCT02992314|"~     Patients taking chemotherapeutic agents often do not comply well with their dosing regiment~     since many of these medications cause a metallic taste in the mouth. The primary intent is~     to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth~     associated with various chemotherapeutic agents. This clinical study a randomized,~     double-blind, single-treatment, parallel design with a placebo as the control. The duration~     of the trial will be 1 month.~   "
4961|NCT02992301|"~     Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will~     effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and~     LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high~     intensity statin therapy and only able to tolerate low potency statin or low weekly dose of~     high potency statin and have LDL-C ≥100 mg/dl; (b) initiate alirocumab at 150mg~     subcutaneously injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6~     and 12 months; (d) perform quantitative analysis for vascular inflammation and plaque LRNC~     volume and other plaque characteristics; (e) compare vascular inflammation and LRNC volume~     between pre- and post-alirocumab at 3, 6 and 12 months.~      Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a),~     non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we~     will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at~     baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels~     between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with~     changes atherosclerotic plaque characteristics.~   "
4962|NCT02992288|"~     The objective of the study is to find the optimal dose of once daily oral neladenoson~     bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with~     reduced ejection fraction (HFrEF).~   "
4963|NCT02992275|"~     This study will examine the addition of neuromuscular electrical stimulation (NMES) on the~     hip abductors during strength training and a fall prevention program for improving muscle~     strength and improving balance. All individuals in this study will receive NMES to their hip~     abductors and will participate in a fall reduction program.~   "
4964|NCT02992262|"~     Pediatric emergency department (PED) physicians frequently encounter children with symptoms~     that warrant evaluation of the optic disc for suspected increased intracranial pressure~     (ICP) such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by~     the PED physician, is considered an essential modality for assessment of the optic disc and~     the diagnosis of papilledema. Obtaining good visualization of the optic disc requires~     patient compliance, the ability to open the eyelids, the absence of opacities in the ocular~     media and a sufficiently large pupillary aperture. Hence, different levels of PED physician~     training, lack of cooperation, significant ocular or periorbital trauma, contraindications~     to mydriasis and severe photophobia may hinder direct fundoscopic evaluation.~      In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic~     examination. The investigators aim to evaluate the yield of optic disc height as measured~     with ocular point of care ultrasound to detect optic disc swelling in comparison to~     ophthalmologic examination as the gold standard.~   "
4965|NCT02992249|"~     This is a prospective uncontrolled observational study to evaluate clinical outcomes~     following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for~     closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting~     for closure, and associated skin graft donor sites, in patients who lack adequate available~     skin to harvest for conventional grafting. Treatment with the ReCell device may be performed~     as part of a single operative procedure, or multiple staged procedures as deemed clinically~     necessary. Adverse events associated with the use of the ReCell device/cell suspension will~     be documented. Subjects will be followed for 1 year following ReCell treatment.~   "
4966|NCT02992236|"~     Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on~     renal function and perfusion in 16 healthy subjects.~   "
4967|NCT02992223|"~     Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose~     chemotherapy followed by autologous stem cell transplant could improve prognosis in patients~     affected by relapsed/refractory aggressive non Hodgkin lymphoma~   "
4979|NCT02992067|"~     To establish a predicting system on axillary lymph node metastasis based on peripheral blood~     CK19mRNA and contrast-enhanced ultrasound.~   "
20404|NCT02790112|"~     This study evaluates the influence of early adiposity rebound, genetic polymorphisms and~     GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.~   "
4968|NCT02992210|"~     Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex~     multimodel therapy and therefore, novel approaches are urgently needed. The investigators~     are attempt to treat these diseases using T cells genetically modified with a 4th generation~     lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9~     domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill~     tumor cells through the recognition of GD2, a surface protein expressed at high levels on~     many types of tumors but not on normal tissues. This study will evaluate the side effects~     and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.~   "
4969|NCT02992197|"~     Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines~     work remarkably well in high-income countries, but for unclear reasons they underperform in~     low-income countries. A double-blind, randomized control trial will be performed to evaluate~     whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can~     improve immune responses among infants in Dhaka, Bangladesh.~      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6~     and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum~     rotavirus-specific IgA responses to determine vaccine immunogenicity.~   "
4970|NCT02992184|"~     The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive,~     Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase~     chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from~     patients with chronic hepatitis C and non-infected controls.~   "
4971|NCT02992171|"~     This study seeks to develop and pilot-test an oncology nurse-led care management~     intervention to meet the primary palliative care needs of patients with advanced hematologic~     malignancies.~   "
4972|NCT02992158|"~     The goal of this project is to train community mental health therapists in behavioral~     activation (BA) treatment for major depressive disorder and then to conduct a study~     examining the feasibility of evaluating the effectiveness of BA in this setting.~   "
4973|NCT02992145|"~     This study aims to compare between androgens level (serum total and free testosterone) in~     women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).~   "
4974|NCT02992132|"~     To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and~     aggression after 12 weeks of treatment~   "
4975|NCT02992119|"~     Targeted malaria elimination (TME), which comprises appropriate case management by village~     health workers, vector control and mass drug administration, is currently being implemented~     through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the~     scale-up of the intervention to the regional level are underway. Based on mathematical~     modelling, extending the post-TME parasitaemia-free period in the majority of villagers for~     as short as 200 days will substantially increase the chances of achieving the interruption~     of malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short~     term malaria protective effect is stronger than the overall effect assessed over 1-2 years.~     Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed~     additional protection.~      Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian~     populations. This trial will generate the required data for the use of this vaccine in Asian~     populations. For integration with the current TME activities, which provide mass drug~     administrations at months M0, M1, and M2, it would be most efficient and practical to~     provide the vaccine at the same intervals. To address a two round intervention (M0, M2)~     where a three round intervention is not feasible, one study arm will look at the immune~     response generated by only two doses of vaccine and antimalarial medications. Recent~     evidence suggests that a vaccination schedule which includes a fractional dose of RTS,S/AS01~     (1/5th of the standard dose) could be similarly or more protective than a schedule with~     three standard full doses, while requiring less vaccine and resources. The trial therefore~     includes study arms which will assess the safety and immunogenicity of fractional dose~     schedules.~      Each participant will be randomized into one of the following study arms in a ratio of~     20:20:30:30:30:30:30, as follows:~        -  RTS,S/AS01B Fractional dose group (Group 1)~        -  Double RTS,S /AS01E Fractional dose group (Group 2)~        -  RTS,S/AS01E Standard dose group (Group 3)~        -  RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4)~        -  RTS,S/AS01E Fractional dose group (Group 5)~        -  RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6)~        -  RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)~   "
4976|NCT02992106|"~     The rising worldwide prevalence of obesity and its subsequently rising incidence of~     concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for~     the health care and associated health care costs of future generations. Obese pregnant women~     are a growing population of interest because their offspring is at risk for childhood~     obesity, an adverse metabolic and inflammatory profile and possible endothelial dysfunction.~     However, strong evidence is still lacking regarding the hypotheses on the early origin of~     these long-term health consequences.~      Consequently there is no comprehensive data available on the contribution of changing~     maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse~     metabolic and endothelial programming of the offspring.~      The investigators of this study want to provide additional data on the body composition,~     metabolic and inflammatory state as well as endothelial function of children of obese~     pregnant women women and compare the outcome with children born from normal weight women.~     Furthermore, the investigators of this study will stratify the obese pregnant women into 3~     groups: women who did not underwent an intervention, women who underwent a weight changing~     intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent~     bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the~     diverse groups of participating children, except the control group, there will be a certain~     grade of endothelial dysfunction, even if there was a normalization of weight, insulin~     sensitivity and inflammation before conception or delivery in the mother.~   "
4977|NCT02992093|"~     The type-2 diabetes mellitus（T2DM）, metabolic syndrome, cardiovascular disease complications~     induced by polycystic ovary syndrome(PCOS) with insulin resistance(IR）, which become serious~     threat to public health. In this observational study, obese patients with PCOS,nonobese~     patients with PCOS, PCOS patients with impaired glucose tolerance（IGT）, PCOS patients with~     type-2 diabetes mellitus（T2DM）, and healthy volunteers would enrolled into this study,~     through the Liquid Chromatography-Mass Spectrometry coupled to Mass Spectrometry（~     LC-MS/MS）and Rapid Resolution Liquid Chromatography（RRLC） and Quadrupole Linear~     Trap（QTRAP）Mass Spectrometry coupled to Mass Spectrometry （MS/MS）analysis of serum samples~     collected from PCOS patients and healthy volunteers to screen the biomarker of diagnosis for~     PCOS with insulin resistance, to explore the correlation between traditional chinese~     medicine （TCM） syndrome（phlegm, kidney yin deficiency, kidney yang deficiency, qi stagnation~     and blood stasis，dampness-heat of liver channel）and metabolites of PCOS.~   "
4978|NCT02992080|"~     The aim of our study is to assess miRNAs expression profiles in the circuling blood of~     patients with cystic fibrosis and highlight signatures that could reflect the pulmonary~     status of patients~   "
25908|NCT02718027|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Alport~     disease from plasma.~   "
4980|NCT02992054|"~     Randomized controlled trial for assessing the effects resulting from an innovative~     occupational program using new technologies (KODRO) on nursing home residents' quality of~     life~      Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a~     national priority (2010 report from French ANESM).~   "
4981|NCT02992041|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic~     drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind,~     parallel, placebo-controlled study.~   "
4982|NCT02992028|"~     1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the~          shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of~          rotator cuff tear.~           As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the~          rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear~          annually more than 300,000 have been performed according to US statistics.~           Rotator cuff repair is a successful procedure, both objectively and subjectively, with~          regard to pain relief and functional outcome.~        2. postoperative pain management after rotator cuff repair Shoulder surgeries are~          associated with a level of postoperative pain requiring opioid use for several days.~          The opioid requirements after shoulder surgery have been reported to be similar to~          those required after gastrectomy or thoracotomy, which might cause several~          opioid-related side effects, such as nausea and vomiting, pruritus, urinary distention,~          and constipation. Although the introduction of arthroscopy has reduced postoperative~          pain, a considerable proportion of patients suffer from moderate to severe acute~          postoperative pain, as its benefit is typically apparent after a few days.~          Consequently, proactive pain control is also required during the first 24-48 h after~          arthroscopic shoulder surgeries, just like in open surgeries. Adequate pain management~          during the immediate postoperative period is not only important for patient~          satisfaction and well-being, but also for facilitating postoperative rehabilitation and~          preventing persistent postsurgical pain.~      Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after~     otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to~     have anti oxidant action, and fewer side effects.~      However, there is no report about the analgesic effect of vitamin C after arthroscopic~     rotator cuff repair.~      The purpose of this trial was to compare the effects of a intravenous vitamin C injection on~     postoperative pain and opioid consumption versus non-treated group after arthroscopic~     rotator cuff repair.~   "
4983|NCT02992015|"~     Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite~     many past clinical trials, has never been shown to respond to chemotherapy. Radiation~     therapy (RT) is effective in extending life but is not curative; median overall survival is~     11 months. It is still unclear why the hundreds of clinical trials involving chemotherapy of~     DIPG have failed to demonstrate any activity against the tumor. Given that many agents tried~     in clinical trials cross the blood brain barrier (BBB), it is possible that there are~     factors specific to DIPG and its location that prevent adequate drug penetration.~     Gemcitabine has been selected for this study because there is strong evidence of DIPG cell~     line inhibition in vitro and good BBB penetration. Furthermore, pediatric dosing and~     toxicity has been established in prior studies of children with relapsed solid tumors and~     leukemia.~      The primary aim of this study is to determine the presence of gemcitabine in childhood DIPG~     tissue after systemic treatment with the drug. The secondary aim is to quantify the~     intratumoral gemcitabine concentration after systemic treatment.~      Participants in this study will be given a one time IV dose of gemcitabine prior to having~     standard of care surgery. During surgery biopsies will be obtained for clinical and research~     purposes along with a blood sample. Because patients will be undergoing this biopsy as part~     of their standard of care therapy here at Children's Hospital Colorado, this is an optimal~     time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug~     is penetrating the tumor. Patients will then enter a follow-up period for 30 days post~     surgery.~   "
4984|NCT02992002|"~     The study investigates the influence of a clinically indicated fluid challenge on~     end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data~     will be collected before, during and after infusion of 500 ml of crystalloid solution in~     mechanically ventilated patients on an operative intensive care unit.~   "
4985|NCT02991989|"~     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength~     declining up to twice as fast as muscle size. This may eventually lead to loss of~     independence if tasks of daily living become too strenuous to be performed safely. Exercise~     is recognized as a safe and effective means to counteract muscle loss during aging, however~     access to gym equipment may be logistically challenging or unpalatable to older adults. This~     research is designed to investigate the effect of 28 days of home-based leg exercise that~     doesn't require exercise equipment or supervision (exercise snacking), accompanied with a~     daily protein supplement in the form of commercially available yogurt, on the skeletal~     muscle health (i.e. function and size) of independent, community-dwelling older adults. To~     achieve this, two groups will be compared; one group will undertake exercise snacking and~     consume a 150 g yogurt with the breakfast meal for four weeks, with the second group only~     receiving the daily yogurt with no exercise snacking.~   "
4986|NCT02991976|"~     This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and~     patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid~     with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.~   "
4987|NCT02991963|"~     This is an observational study (case-control study) aiming to identify risk factors for~     malaria infection in health centers or malaria posts or district hospitals in Buntharik~     District and Nachalui District, Ubon Ratchathani Province, Thailand.~      This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases)~     subject. One-to-one matching of cases (malaria positive) and controls (malaria negative)~     will be done at each study site.~      CASE (Malaria positive) subject will go through the following;~        1. Enrollment visit (Day 0)~           1.1 Blood collection of three dried blood spots, and malaria slide. In district~          hospitals in individuals >14 kg: additional 10ml venous blood will be collected.~           1.2 A survey questionnaire which includes patient demographics, information on malaria~          treatment, bed net use and possible risk factors for acquiring malaria, as well as~          questions about their travel and usage of mobile phones will be administered.~        2. Follow up visits (if fever plus Day 42 (+/-3))~      2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals:~     additional 0.5ml venous blood will be collected.~      2.2 Short survey questionnaire including questions on symptoms, travel and possible risk~     behaviors since enrollment will be administered.~      CONTROL (Malaria negative) subject will go through the following;~        1. Enrollment visit (Day 0)~           1.1 Blood collection to confirm negative malaria slide. In district hospitals:~          additional 0.5ml venous blood will be collected.~           1.2 A survey questionnaire including patient demographics, information on any recent~          malaria treatment they may have taken, bed net use and possible risk factors for~          acquiring malaria, as well as questions about their travel and usage of mobile phones~          will be administered.~        2. Follow up visit: No follow up visit~   "
4988|NCT02991950|"~     Prospective randomized study of patients with infertility candidates to Assisted~     ReproductiveTechniques (ART), screened for all inclusion and exclusion criteria, submitted~     to ART cycle with or without low molecular weight heparin (LMWH) administration. Aims of the~     study are to evaluate, primarily, pregnancy rate/embryo transfer, secondarily take home~     babies/embryo transfer, implantation rate, and the role of thrombophilic factors~   "
5003|NCT02991755|"~     The purpose of this study is to determine whether the use of 5-0 prolene during repair of~     linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0~     fast absorbing gut (both SOC).~   "
5004|NCT02991742|"~     Contrast media-induced nephropathy following diagnostic and therapeutic cardiac~     catheterization.~   "
4989|NCT02991937|"~     This is a randomized controlled trial of 190 subjects comparing non-operative management~     with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis~     is that antibiotics are not worse than surgery for the treatment of uncomplicated~     appendicitis in children. The primary outcome will be survey scores on the Pediatric Quality~     of Life Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will~     include child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and~     60-day success of non-operative management; readmission rates for both groups; and long-term~     complications over one year.~   "
4990|NCT02991924|"~     The purpose of this study is to investigate risk factors for mediastinal lymph node~     metastasis in potentially operable non-small cell lung cancer in order to find indications~     for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial~     ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound~     with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal~     staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed.~     The investigators develop the prediction method for mediastinal metastasis.~   "
4991|NCT02991911|"~     The purpose of this study is to assess the safety and tolerability, describe the~     dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum~     administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726~     in subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide,~     with or without a prior taxane-based chemotherapy in the mCRPC setting.~   "
4992|NCT02991898|"~     This is a single center pilot study of a non-myeloablative umbilical cord blood transplant~     for the treatment of a hematological malignancy with a single infusion of T regulatory~     (Treg) given shortly after umbilical cord blood transplantation and supported with ultra-low~     dose (ULD) IL-2 for 4 weeks. The goal of the study is to demonstrate the feasibility and~     safety of giving ULD IL-2 to support in vivo Treg survival and help with the design of~     future larger scale studies.~   "
4993|NCT02991885|"~     The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1~     subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the~     safety and tolerability in adolescents and children with peanut allergy.~   "
4994|NCT02991872|"~     The purpose of this study is to evaluate the long-term persistence of immune responses~     approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in~     2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the~     subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged~     ≥6 and ≤17 years at the time of enrollment.~      This study is aimed to respond to a post-marketing commitment by the China Food and Drug~     Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo~     cell rabies vaccine license in China, granted in August 2015.~   "
4995|NCT02991859|"~     This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,~     aiming to investigate whether higher potency of different inhaled corticosteroid confers an~     improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It~     will compare the dose response for topical efficacy via airway responsiveness (to~     adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via~     24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for~     the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)~     and budesonide (BUD).~      There will be a screening visit 7-28 days before the first dose of study treatment, and a~     minimum 4-day run-in period before the first dose of study treatment. Subjects will be~     randomized to one of 12 treatment sequences, and will have two treatment periods, each~     comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo.~     There will be a 25- to 42-day washout period between treatment periods. The study duration~     for each subject will be approximately 22 weeks including the follow-up period.~   "
4996|NCT02991846|"~     Prospective, observational, multicentre, spontaneous, non-interventional study This study~     will evaluate all consecutive patients who develop chronic graft-versus-host disease,~     reported by the Italian GITMO centers according to a standardized Web platform for~     real-time, onsite data collection. The platform for data collection will be based on a~     software prototype developed by the Clinica di Ematologia di Ancona Transplant Center for~     the management of patients with chronic graft-versus-host disease. This software has been~     integrated with algorithms that automatically determine: severity of chronic~     graft-versus-host disease and overall response according to the 2015 NIH consensus criteria.~   "
4997|NCT02991833|"~     The aim of this randomized controlled clinical trial, prospective study is to developing a~     new incontinece care product for controlling the fecal and urinary incontinence and to~     examine the effect of this new product on prevention of perineal dermatitis.~   "
4998|NCT02991820|"~     This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional~     direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the~     performance of users. This will involve the use of an intubating pediatric manikin to assess~     various aspects of endotracheal intubation by experienced and inexperienced users.~   "
4999|NCT02991807|"~     Phosphatase and TENsin homolog (PTEN) gene germline mutations are associated with a spectrum~     of clinical manifestations characterized by neurocognitive deficits, intellectual~     disability, autism symptomatology, skin lesions, macrocephaly, hamartomatous overgrowth of~     tissues, and an increased risk of cancers. Investigators are conducting research to evaluate~     the potential safety and efficacy of RAD001 (everolimus) in this patient population, and the~     potential neurocognitive benefits from treatment with RAD001 or placebo for a six month~     period. The investigators hope this trial will lead to a better understanding of PTEN and to~     new forms of treatment that may benefit children and adults with PTEN in the future.~   "
5000|NCT02991794|"~     The aim of the study is collecting clinical data on the learning curve of different surgeons~     using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.~   "
5001|NCT02991781|"~     This study will develop and experimentally test the efficiency of a neurofeedback training~     protocol vs. varenicline use for smoking cessation.~   "
5002|NCT02991768|"~     The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea~     will be effective and safe for kidney transplant patients, allowing them to continue with~     MPA medication.~   "
5007|NCT02991703|"~     Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse~     wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which~     uses applanation tonometry. It is used in adults and children. An easier method called~     pOpmètre using saturation sensors is validated in adults but not in children. The objective~     of this study is to compare the pulse wave velocity values measured with the pOpmètre® with~     those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.~   "
5008|NCT02991690|"~     This study is a prospective multi-center trial designed to determine the safety profile and~     efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)~     Spinal Cord Injury (SCI).~   "
5009|NCT02991677|"~     Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare~     concern. It is painful, persistent, resistant to conventional pain therapies, and results in~     long-term suffering and decreased quality of life for many cancer survivors. The role of~     exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the~     goal of identifying the mechanisms associated with this therapeutic approach to manage~     CIPN-NP.~   "
5010|NCT02991664|"~     The aim of this clinical trial was to compare the clinical performances of a glass ionomer~     restorative system with a micro hybrid resin based composite in extended sized class II~     cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative~     system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were~     evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria.~     Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).~   "
5011|NCT02991651|"~     Patient selection: a) Pathological confirmation of non-small cell lung cancer without~     activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion)~     with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant~     women are excluded; e) Informed consent.~      Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal~     function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging~     evaluation including CT-chest or PET/CT scan;~      Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using~     intra-patient dose escalation for dose levels 1 and 2. These study agents will be~     administered orally until progression of disease, unacceptable toxicities, activation of a~     phase II study of the combination, or exhaustion of the IRX4204 drug supply.~      Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common~     Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the~     RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.~   "
5012|NCT02991638|"~     Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other~     indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B~     virus carriers~   "
5013|NCT02991625|"~     Drugs used for managing chronic pain have not proven to be effective and chronic pain~     continues to cost Canadians $60 billion a year without truly helping those who suffer. The~     study proposes to investigate the factors related to a person that can enhance or reduce the~     effectiveness of pain treatments in people suffering with chronic pain. Treatment response~     to pain killers in a person may be related to their brain, genetics, social, and~     psychological makeup. The investigators aim to study these factors to identify and develop~     feasible and robust indicators based on a person's biological makeup (also called~     biomarkers). These biomarkers will allow doctors and researchers to predict more accurately~     which treatment and prevention strategies for a particular disease will work in which groups~     of people. These measures will offer new opportunities for improving treatment such as by~     tailoring treatment to meet the specific needs of each patient based on his/her biological~     and psychological makeup. Towards the specific aim, data will first be collected in several~     experimental domains for studying treatment expectations (cognitive, psychosocial,~     brain-related, genetic). These 'experimental' data will be compared between chronic back~     pain (CBP) and healthy participants to yield new understanding of the factors that govern~     treatment response. At the end of experimental data collection, the investigators will~     collect data in the 'clinical' domain. Hence, at the end of the experimental sessions, a~     subset of CBP participants will receive a mock drug (placebo disguised as an approved pain~     treatment) and another subset will provide pain ratings only and hence serve as a waiting~     list control for the placebo trial. Data will be studied in steps to understand factors that~     mediate treatment outcomes and finally the investigators will use advanced computational~     tools used for big data analysis and aim to identify factors that can be used as biomarkers~     and precision medicine tools.~   "
5014|NCT02991612|"~     The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the~     treatment of cirrhotic gastroesophageal variceal bleeding.~   "
5015|NCT02991599|"~     This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune~     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three~     injections at months 0, 1, and 6 in methadone maintenance treatment patients.~   "
5016|NCT02991586|"~     Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal~     ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health~     resources, coupled with the suffering of families who feel helpless and difficulties in~     handling.~      The purpose of the study is to evaluate the effectiveness of a dialectical behavior therapy~     (DBT) for parents of adolescents with IE who are in treatment in the different network~     devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals~     are the development of communication skills, validation and crisis management as well as~     increase understanding and competence of the pathology.~      To evaluate the effectiveness of the DBT family group intervention, it is compared with a~     group of non-treatment or treatment as usual (outpatient treatment and parents without~     children specific group treatment). The DBT intervention will begin with two individual~     sessions with parents of patients and 10 theoretical and practical seminars in group format~     (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be~     added to standard treatment that a patient with IE receives in the investigative devices.~      The result of these interventions will be measured after the end of treatment and after 6~     and 12 months after the treatment ends. The variables considered are family communication,~     cognitive skills, emotional and behavioral coping clinical in parents and as indirect~     measures of change in adolescents health resources used as , suicidal gestures, self-harm or~     aggressive behavior.~   "
5032|NCT02991365|"~     Obesity if known to be associated with brain insulin resistance in humans. This condition~     has not only implication for the brain but also for whole-body energy homeostasis. Research~     in rodents indicates that weight loss is able to improve insulin sensitivity of the brain.~     The current project will test this hypothesis in humans. Therefore, brain insulin~     sensitivity will be assessed by fMRI in combination with intranasal insulin administration,~     using an established protocol. Furthermore, effects of daily administration of insulin nasal~     spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.~   "
5017|NCT02991573|"~     Damage to teeth from decay or previous old silver fillings can be repaired with~     tooth-coloured filling materials that stick to the tooth. These materials have been around~     for some years and have become more sophisticated; with greater ease of placement by the~     dentist and better durability for the patient. The fillings are designed to be used in~     combination with a specific glue (adhesive) that is designed to stick to the different parts~     of the tooth to provide a good seal, the outer enamel and the inner dentine.~      This study will examine the performance of a state-of-the-art modern tooth coloured filling~     material (Ceram X) in combination with an existing adhesive (control adhesive) and a new~     adhesive (Prime & Bond Universal) used in two different techniques; both of which are known~     to work but one is easier to apply. This results in three treatment groups.~      At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all~     other medical devices used. Thus, this study is not conducted to meet any regulatory~     requirements. The rationale of this study is the extension of knowledge primarily concerning~     the clinical performance of Prime&Bond Universal in molars.~      Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75~     restorations in total) to assess the performance of the materials in a comparative design.~     The study restorations will be monitored for a period of 18 months (with the option to~     extend the evaluation period to 48 months).~      After placement of restorations under controlled clinical conditions, the primary objective~     of the study is the determination of post-operative sensitivity and pulp vitality, marginal~     adaptation and staining of margins of the restorations. In addition, fracture of material~     and retention, recurrent caries, occlusal contour and wear, approximal anatomical form will~     be determined as well as the failure rate as defined by the ADA.~   "
5018|NCT02991560|"~     To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic~     (Athletic Tape) taping as part of the conventional physiotherapy of the lateral~     epicondylitis using the results from ultrasonography and clinical tests.~   "
5019|NCT02991547|"~     The purpose of this study is to find out more information about patients who have cancer~     (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated~     with chemotherapy and radiation but have not had surgery. The study will follow patients for~     5 years to monitor for their cancer and to see how the standard medical care affects the~     daily life of patients.~   "
5020|NCT02991534|"~     Background: Women Veterans are the fastest growing segment of Veterans Health Administration~     (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist~     in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety,~     and mental health comorbidity are disproportionately high among women Veterans. Furthermore,~     a high rate of women Veterans' attrition from VA care, along with organizational barriers to~     care, substantiate that organizational changes are needed in order to engage and retain~     women Veteran VHA users in evidence-based, patient-centered care.~      Objectives: The Enhancing Mental and Physical health of Women through Engagement and~     Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing~     personalized, proactive, patient-centered care models, and Transformational Strategy 7.2.g~     by implementation of innovative care models in women Veterans' health care. The EMPOWER~     QUERI Program is designed to improve women Veterans' engagement and retention in~     evidence-based care for three high priority health conditions, i.e., prediabetes,~     cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive~     portfolio of projects with the following aims: (1) To use an evidence-based implementation~     strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement,~     and systematic evaluation of complex implementation processes in order to enrich~     organizational capacity for innovations in women Veterans' VHA health care; (2) To implement~     personalized, proactive, patient-centered innovations in VHA women's health that are~     acceptable, feasible, satisfactory, relevant, and effective for both providers and patients,~     thereby encouraging women Veterans' engagement and retention and sustainability of the~     innovations; and, (3) To generate implementation playbooks for our partners that are~     scalable and serve as guidance for future implementation of a broader array of~     evidence-based women's health programs and policy.~      Methods: Three projects will be conducted by an experienced multidisciplinary team.~     Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs is a one-year QI~     project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans~     with prediabetes will select an in-person, peer-led or online gender-specific,~     evidence-based diabetes prevention program to address their risk behaviors and health~     conditions. Facilitating Cardiovascular Risk Screening and Risk Reduction in Women~     Veterans will increase identification of CV risk among women Veterans, enhance~     patient/provider communication and shared decision-making about CV risk, and provide a~     supportive, coordinated health coaching intervention to facilitate women Veterans'~     engagement and retention in appropriate health services. Implementation of Tailored~     Collaborative Care for Women Veterans will evaluate implementation of an evidence-based~     collaborative care model tailored to enhance provider- and system-level capabilities to~     address women Veterans' anxiety and depression treatment needs, thereby improving~     organizational primary care-mental health integration (PC-MHI) effectiveness and women~     Veterans' engagement and retention in PC-MHI. Both implementation research studies will use~     a modified stepped wedge design and will apply the evidence-based Replicating Effective~     Programs (REP) implementation strategy. Mixed methods implementation evaluations will focus~     on investigating primary implementation outcomes of adoption, acceptability, feasibility,~     and reach. Multilevel stakeholder engagement will be prioritized. Program-wide~     organizational-, provider-, and patient-level measures and tools will be utilized to enhance~     synergy, productivity, and impact. As a coherent program of women's health implementation~     research and quality improvement, the proposed EMPOWER QUERI will constitute a major~     milestone in achieving BPE strategies and realizing women Veterans' engagement and,~     ultimately, empowerment in our VHA system.~   "
5021|NCT02991521|"~     This research study aims to improve the standard exam called Focused Assessment with~     Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an~     abdominal bleed. The study will see if having patients roll on their right side improves the~     FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients~     with bleeding.~   "
5022|NCT02991508|"~     This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to~     identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.~   "
5023|NCT02991495|"~     In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks~     occurring concurrently and the risk of further spread through the African continent and even~     to Asia, was larger than the available supply. In this situation, the World Health~     Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever~     vaccine as a dose-sparing strategy. These recommendations were based on limited number of~     clinical trials and additional studies should assess the applicability of the fractional~     dose to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the~     performance of the fractional dose in young children and populations in Africa including~     those with HIV.~      This study aims to respond to some of the research questions that would allow broadening the~     recommendations on the use of fractional doses of yellow fever vaccine in emergency~     situations. The study will be conducted in Uganda and Kenya and the main objective is to~     assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose~     compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the~     study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity~     and persistence of protective antibody levels; describe the geometric mean titre and the~     change in neutralizing antibody on Day 28 days after vaccination with fractional and full~     doses; and assess the occurrence of adverse events and serious adverse events (SAE) during~     28 days after administration of fractional and full doses.~      The study consists of a randomized non-inferiority trial. The study aims to start in April~     2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be~     reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for~     the studies in children and HIV positive adults.~   "
5024|NCT02991482|"~     Trial comparing standard treatment (chemotherapy) with pembrolizumab treatment in patients~     with advanced pretreated malignant mesothelioma.~   "
5025|NCT02991469|"~     Primary Objective:~      To describe the pharmacokinetic (PK) profile of sarilumab in patients with sJIA in order to~     identify the dose and regimen for continued development in this population.~      Secondary Objective:~      To describe:~        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients~          with sJIA.~        -  The long term safety of sarilumab in patients with sJIA.~   "
5026|NCT02991456|"~     The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral~     rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)~     patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a~     randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the~     prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving~     RT and concomitant multi-dose TMZ.~   "
5027|NCT02991443|"~     Parents of children with chronic diseases often report increased level of stress and~     anxiety. The aim of the study is to assess the effect of mindfulness based stress reduction~     (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel~     diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified~     psychologist. 30 parents will participate. The efficacy of the intervention will be assessed~     by 3 validated questionnaires which will be filled by each participant prior to~     intervention, at the end of intervention and 3 months following interventions.~   "
5028|NCT02991417|"~     This clinical study is conducted to assess the safety and immunogenicity of a Clostridium~     difficile vaccine (CDVAX) in healthy adult volunteers.~   "
5029|NCT02991404|"~     Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either~     multimodal single injection adductor canal block with sham infusion catheter or continuous~     infusion of local anesthetic (control) for postoperative analgesia.~      Primary end point is pain scores at 30 hours post performance of block procedure.~   "
5030|NCT02991391|"~     This cross-sectional survey study is intended to describe the characteristics of adults in 4~     US states with regards to respiratory symptoms and tobacco exposure, utilizing an existing~     state-administered, CDC overseen Behavioral Risk Factor Surveillance System telephone health~     survey. The primary goal of study is to describe the sociodemographics, health behaviors,~     and presence of chronic diseases in persons with or at risk of having chronic obstructive~     pulmonary disease.~   "
5031|NCT02991378|"~     This study is about early intervention for preschool children with emotional and stress~     related disorders. To develop a set of program that could be used in district hospitals for~     early intervention of preschool children with emotional and stress related disorder or~     problems.~   "
5063|NCT02990949|"~     The aim of this study is to examine the length of ovarian stimulation with the timing of~     trigger in an IVF cycle and its potential to impact patient outcomes.~   "
5033|NCT02991352|"~     Treatment of vascular malformations requires the placement of a needle within anatomically~     non well defined, pathological vessels, which may be as small as 1 mm, with the current~     state of the art relying exclusively on two dimensional fluoroscopy images for guidance. The~     investigators hypothesize that the combination of stereotactic image guidance with existing~     targeting methods will result in faster and more reproducible needle placements.~   "
5034|NCT02991339|"~     The investigators were aiming to evaluate whether dexamethasone administration accelerates~     the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy~     liver failure and its safety in the subjects who developed elevated serum total bilirubin.~   "
5035|NCT02991326|"~     This study aim to contribute with the investigation of the therapeutic effect of osteopathic~     manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with~     temporomandibular disorder who make use of occlusal splints.~   "
5036|NCT02991313|"~     The purpose of this trial is to assess acute safety and performance of the Multi-electrode~     Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for~     the treatment of Persistent Atrial Fibrillation.~   "
5037|NCT02991300|"~     The data registry will increase the knowledge of outcomes for treatment of focal cartilage~     defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring~     of the clinical safety and performance of the device and surgical implantation kit~   "
5038|NCT02991287|"~     To asses the precision of a score to predict chronic post surgical pain in patients~     undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and~     thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.~   "
5039|NCT02991274|"~     The study primary objective is to assess the concordance of T790M resistance mutation~     testing from hospital-based laboratories with T790M resistance mutation testing from a~     central laboratory.~   "
5040|NCT02991261|"~     The objective of the study is to determine the relative bioavailability, safety and~     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects~   "
5041|NCT02991248|"~     This study is to test whether pelvis perturbation training paired with transcutaneous spinal~     direct current stimulation (tsDCS) will be effective in improving dynamic balance and~     locomotor function in humans with SCI. One group will receive pelvis perturbation training~     paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and~     one group will receive treadmill training only.~   "
5042|NCT02991235|"~     A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label~     extension study.~   "
5043|NCT02991222|"~     The objective of the study is to determine the relative bioavailability, safety and~     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects~   "
5044|NCT02991209|"~     The overall purpose of the study is to evaluate the effect of 12 months testosterone~     replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in~     order to reduce the risk of cardiovascular disease.~      The primary study objective is to evaluate changes in insulin sensitivity. The secondary~     study objective is to evaluate changes in the prevalence of metabolic syndrome, body~     composition, systemic inflammation and symptoms of testosterone deficiency.~   "
5045|NCT02991196|"~     This trial is being performed in two parts: Dose Escalation and Dose Expansion.~      The primary objective for the Dose Escalation part is to determine the safety and~     tolerability at different doses of DS-8273a administered in combination with nivolumab and~     to identify the dose combination for the Dose Expansion cohort in subjects with mismatch~     repair (MMR)-proficient advanced colorectal cancer.~      The primary objectives for the Dose Expansion part are:~        -  To further evaluate the safety and tolerability of DS-8273a administered at the~          selected dose in combination with nivolumab in subjects with MMR-proficient advanced~          colorectal cancer~        -  To evaluate preliminary anti-tumor activity of DS-8273a plus nivolumab administered at~          the selected dose in subjects with MMR-proficient advanced colorectal cancer~   "
5046|NCT02991183|"~     Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice~     and accept difficult thoughts and emotions. ACT also helps people to identify what they~     value in life (e.g. a good relationship with their partner) and make changes to their~     behaviour to promote these values. Carers of people with dementia may experience reduced~     wellbeing associated with their role. Those whose wellbeing is greater than previously are~     said to be 'flourishing'.~      Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group~     intervention for carers of people with dementia.~      Methods: Participants will include adult carers of people with dementia. Study participants~     will be identified from two older people community mental health teams. Informed consent~     will be sought prior to group invitations being sent out. There will be two groups in total~     (12 in each group) and both groups will attend three 2.5 hour sessions of ACT. All~     participants will complete questionnaires at the beginning and 21 days later (asking~     questions about their thoughts and feelings, flourishing and about being a carer). Eight~     group participants will be invited to a focus group to understand what they found more~     helpful and less helpful.~      Applications: Results from this study will potentially provide useful information to enable~     a further study with more participants to be conducted. The outcomes of this study will be~     shared with older people community mental health teams, dementia and carer specialist groups~     and potentially published in a relevant journal.~   "
5047|NCT02991170|"~     Patients with myocardial infarction related potential malignant ventricular arrhythmia have~     high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy~     of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG)~     Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular~     arrhythmia at the same time. The observation indexes include the morbidity of potential~     malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term~     after CABG surgery.~   "
5048|NCT02991157|"~     This prospective observational study will assess the regional cerebral oxygen saturation and~     cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine~     administration for the prevention/management of cerebral vasospasm.~   "
5049|NCT02991144|"~     A Phase 1/2, open-label dose-finding safety study of single ascending doses of DTX301 in~     adults with late-onset OTC Deficiency~   "
5050|NCT02991131|"~     This open-label, prospective, multi-center, non-interventional, observational, parallel~     cohort study intends to provide real life data on the treatment duration, effectiveness and~     safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real~     practice setting.~   "
5051|NCT02991118|"~     The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo~     in patients with high cardiovascular risk and elevated LDL cholesterol not adequately~     controlled by their current therapy.~   "
5052|NCT02991105|"~     Cancer remains a major cause of morbidity and mortality post solid organ transplantation.~     While mortality from the other leading causes of death post-transplantation (e.g.~     cardiovascular disease and infection) is declining, mortality from cancer~     post-transplantation is increasing. This is due to both general and transplant-specific risk~     factors that combine to increase risk for cancer compared to the general population.~     However, there is a shortage of research exploring cancer epidemiology post solid organ~     transplantation in the UK. This is essential to guide clinicians and for counselling~     patients regarding expectations and outcomes after developing cancer post-transplantation.~     This is especially important as the aetiology, pathophysiology and outcomes of cancer~     post-transplantation may differ from the general population.~      Available data registries in the UK separately contain valuable cancer and~     transplant-specific data that can be combined to explore cancer epidemiology~     post-transplantation more comprehensively, which can be directly translated into patient~     benefit by utilizing transplant-specific data (rather than translating from general~     population or non-UK patient demographics). The purpose of this project is to combine~     existing data resources to link up the complete patient journey for solid organ transplant~     recipients and focus on the entire spectrum of cancer from incidence to mortality.~   "
5053|NCT02991092|"~     To compare the influence of two different fluid administration strategies on the clinical~     efficacy of patients with colorectal carcinoma during the fast-track surgery.~   "
5054|NCT02991079|"~     This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no~     cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).~     It is aimed at assessing the effects of adding an ICT (information and communication~     technology) tool, developed for the Smartphone application and group activities of healthy~     food and cardio-health rides in support of behavioral and educational recommendations in the~     increased physical activity and adaption to the Mediterranean dietary pattern.~   "
5055|NCT02991066|"~     Although the clinical application of differentiation therapy has made great success in the~     treatment of acute promyelocytic leukemia (APL), early fatal bleeding remains an unsolved~     problem which accounts for the main reason of induction failure in APL patients. The~     clinical manifestation of both serious bleeding and thrombosis illustrate the complexity of~     the pathogenesis of coagulopathy in APL. Despite extensive research, the pathogenesis of~     coagulopathy in APL is still unclear. Microparticles, 0.11μm in diameter, are small membrane~     vesicles released to circulation by blood cells and vascular endothelial cells during~     activation or apoptosis. Microparticles (MPs) derived from different cells types all exert~     procoagulant activity mediated by phosphatidylserine (PS) and carry some basic substances~     derived from their origin cells. Also, the biological activity of microparticles is often~     significantly higher than that of the cells they come from. According to these problems and~     background knowledge, our project aims to observe the roles of microparticles derived from~     APL cells and the procoagulant or profibrinolytic activating factors resided on these~     microparticles in the pathogenesis of coagulopathy in APL, and the effects of different~     induction therapies, chemotherapeutic drugs or differentiation agents on these~     microparticles and their procoagulant or profibrinolytic activating factors. To carry out~     this study, microparticles are obtained from patients who undergo different induction~     therapies at different time points or from primary bone marrow APL cells which are treated~     by different drugs in vitro at different time points, the expressions and activities of five~     procoagulant or profibrinolytic activating factors, which are highly expressed in APL cells,~     PS exposure and the functional state of these microparticles, will be dynamically monitored.~     Further study of the pathogenesis of coagulopathy in APL can provide clues and help for deep~     understanding of clinical manifestations, guiding clinical treatment as well as judging~     prognosis, and establishing theoretical basis for exploring new treatment.~   "
5056|NCT02991053|"~     the aim of this study is to compare the effects of Transversus abdominis plane block and~     ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the~     anesthesia and analgesia contributions during surgery without general anesthesia.~   "
5057|NCT02991027|"~     To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton~     devices using two light sources.~   "
5058|NCT02991014|"~     This study aims to compare the impact of listening to frequency-modulated music vs.~     non-modulated music (both researcher-selected), and to test whether there are differential~     effects on pain and stress perception. Further, these two conditions will be compared to a~     third condition, in which participants will be exposed to self-selected non-modulated music.~     It is hypothesized that both researcher-selected frequency-modulated music and self-selected~     non-modulated music result in stronger decreases in stress and pain compared to~     researcher-selected non-modulated music, while it is expected that there will be no~     differences in researcher-selected frequency-modulated music and self-selected non-modulated~     music. The intervention consists of ten sessions of music listening in the course of three~     consecutive weeks.~   "
5059|NCT02991001|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. The hydrodissection~     could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection~     was pervasively used in clinical practice, current researches contain small participant~     without control group or randomized leading to foreseeable selection bias. The investigators~     design a randomized, double-blind, controlled trail to assess the effect after~     ultrasound-guided hydrodissection in patients with CTS.~   "
5060|NCT02990988|"~     The goal of this pilot study is to test whether the microbiome is affected by intravenous~     iron repletion.~   "
5061|NCT02990975|"~     Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis~     Plane Block supported by ketamine sedation only.~   "
5062|NCT02990962|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. Although many~     conservative managements of CTS, the effectiveness of these methods is insignificant or only~     persist for a short duration including steroid injection. Recently, the ultrasound-guided~     perineural injection with 5% dextrose was widely used for entrapment neuropathy with~     positive benefit. The investigators design a randomized, double-blind, controlled trail to~     assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients~     with CTS and compared with steroid injection.~   "
5064|NCT02990936|"~     The purpose of this study is to determine the impact of tumor growth velocity on the~     survival of patients with oropharyngeal squamous cell carcinoma treated by~     (chemo-)radiotherapy.~      Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected~     for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume~     and number and size of pathological neck lymph nodes (small diameter > 1 cm) will be~     assessed on diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the~     summation of areas technique. Tumor progression and tumor doubling time will be calculated~     based on DiCT and RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67~     immunohistochemistry and mitotic index. HPV status will be evaluated by PCR and p16~     immunohistochemistry. Ulcerative or exophytic aspect will be noticed. Tumoral kinetics~     patterns will be correlated with disease free survival and overall survival of patients with~     OPSCC. These patterns will be compared to HPV status and proliferation markers in order to~     study their clinical signification [time frame: 5 years] and develop predictive markers of~     tumor progression for head and neck cancers.~   "
5065|NCT02990923|"~     The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve~     and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream~     infection in hemodialysis patients.~   "
5066|NCT02990910|"~     A high incidence of respiratory morbidity after adenotonsillectomy is reported in children~     with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,~     randomized controlled study to determine the effects of personalized opioid analgesia~     compared with conventional opioid analgesia on respiratory morbidity after~     adenotonsillectomy in Children with OSAS.~   "
5067|NCT02990897|"~     Researchers now know that treating chronic kidney disease (CKD) in its early stages can~     prevent dialysis and reduce heart problems that go along with kidney disease. Computerized~     tools may help primary care doctors to diagnose the disease earlier and computer reminders~     may help doctors to prescribe the best treatments. In this project the investigators will~     test computer reminders in primary care clinics to see if they improve treatment of early~     chronic kidney disease and to see if it can promote referral to nephrology.~   "
5068|NCT02990884|"~     Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and~     anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general~     anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of~     ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.~   "
5069|NCT02990871|"~     All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain~     injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from~     emergency department started a rehabilitative treatment during their hospitalization in ICU.~     Patients transferred from an external ICU started the rehabilitation in neurorehabilitation~     department. Aim of the study is to evaluate if an early rehabilitation, started since the~     acute stage of the damage, is able to reduce the decannulation time in this group of~     patients.~   "
5070|NCT02990858|"~     This is an extension study, to provide continued access to PRO 140 to subjects who complete~     participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO~     140 to form a viable regimen, in the opinion of the treating physician. The patient~     population for this trial are treatment-experienced HIV infected patients with CCR5-tropic~     virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of~     treatment in the PRO140_CD02 study.~   "
5071|NCT02990845|"~     This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane,~     and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable~     locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth~     factor receptor 2 (HER2) negative breast cancer. All the patients will be included in the~     final tolerability and preliminary efficacy analysis. The efficacy objectives including PFS,~     overall response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR).~     Adverse effects will be recorded according to CTCAE v4.0.~   "
5072|NCT02990832|"~     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care~     as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in~     Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there~     were 425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality~     of life of the patients and attendant negative effects on their families. The 5-year~     mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients~     undergoing LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims~     to optimize methods of early detection and treatment of foot ulcers in an effort to reduce~     LLA by 50% by implementing High Risk Foot Teams (HRFTs) across the province starting with 3~     Pilot sites. Existing staff with expertise and knowledge in diabetic foot care will assess~     and treat patients with moderate and high-risk findings.~      In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an~     Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be~     evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been~     demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in~     an easy-to-use format, thus creating an enhanced wound healing environment while supporting~     patient quality of life.~      The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of~     exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing~     under the current standard of care: evaluating key indicators of infection, Infectious~     Diseases Society of America (IDSA) wound classification, and wound size; identifying~     benefits to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction,~     perceived benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt®~     Wound Dressings when combined with the DFCCP.~   "
5073|NCT02990819|"~     This is a Phase II trial to determine the ability of a reduced intensity conditioning~     regimen to allow successful engraftment with alpha/beta T and CD19+ depleted peripheral stem~     cell grafts from unrelated or partially matched related donors. There are two conditioning~     regimens depending upon patient diagnosis and age.~   "
5074|NCT02990806|"~     The purpose of this study is to demonstrate similarity of NI-071 (proposed biosimilar to~     infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in patients~     with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).~   "
5075|NCT02990793|"~     The purpose of this study is to evaluate the safety and efficacy of individualized,~     Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Persistent~     Post-Concussive Symptoms (PPCS) following Traumatic Brain Injury (TBI).~   "
5076|NCT02990780|"~     This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of~     induction chemotherapy followed by accelerated hypofractionated vs. conventionally~     fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.~   "
5077|NCT02990767|"~     The aims of this study are to develop algorithms based on a combination of maternal factors,~     uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early~     Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.~   "
5078|NCT02990754|"~     Fearless Physical Activity are fun, physical literacy events where people with congenital~     heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation~     opportunities without fear (i.e., appropriate for their health). Ontarians with CHD are a~     large and rapidly growing population;1% of children are born with CHD, adding 1,440 new~     children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will~     target CHD children, youth or adults, while encouraging family-based participation. During~     each season, the investigators will offer a one-day event for each age group (children,~     youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events).~     Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto)~     or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable~     beyond this project. Activities will be chosen based on opportunities available in local~     communities at little to no cost (e.g., use of local trails and parks). Event leaders and~     participants will be educated about physical literacy and screening tasks will be used to~     identify those needing significant or specialized physical literacy support. People with CHD~     lead mostly sedentary lives. They are much less active than their friends and colleagues,~     even when their heart disease is mild, and inactivity can contribute to a higher risk for~     heart attacks, stroke, obesity, and depression. Uncertainty about physical activity, even~     though it is recommended (American Heart Association, May 2014), is an important barrier to~     the physical and mental health benefits of physical activity. How much is too much? and~     Will it be too much for my heart? are top-of-mind. Fearless Physical Activity will~     provide children, youth and adults living with CHD with new physical activity experiences~     and opportunities to enhance their physical literacy so they are better able to be active~     for life.~   "
5079|NCT02990741|"~     1. Study name:A randomized clinical trial on atrial fibrillation screening by using an~          automated electrocardiogram system in an elderly Chinese population~        2. Rationale: Failure in the diagnosis and management of atrial fibrillation leads to high~          incidence of stroke and high mortality and disability. It is therefore imperative to~          diagnose and manage atrial fibrillation in a timely and effective fashion to prevent~          the complications of atrial fibrillation.~        3. Objective:The primary objective is to investigate whether more frequent ECG recordings~          and analyses with this automated ECG system (4 times/year) would significantly improve~          the detection of atrial fibrillation compared to a single annual ECG screen.The~          secondary objective is to explore whether even more frequent ECG recordings and~          analyses (8 times/year) would further improve the detection of atrial fibrillation.~        4. Study design: The present study is designed as a randomized controlled trial of~          parallel group (two).~        5. Study population: Men and women aged at least 65 years (n=7000) meet the~          inclusion/exclusion criteria.~        6. Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into~          the usual and intensive screening groups with 3500 patients in each group, and within~          the intensive screening group in a 3:1 ratio into the intensive and more intensive~          subgroups with 2625 and 875 patients, respectively.~        7. Follow up: 1)Usual screening group: ECG recordings at baseline plus at 1 year of~          follow-up; two ECG recordings in total. 2)Intensive screening subgroup: ECG recordings~          at baseline plus quarterly during follow-up, at months 3, 6, 9 and 12; 5 ECG recordings~          in total. 3)More intensive screening subgroup: ECG recordings at baseline plus weekly~          during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4~          and months 3, 6, 9 and 12; 9 ECG recordings in total.~        8. Sample size estimation: The number of required subject for the whole trial is 7000.~        9. Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment :~          June 2017; End of study : June 2018~       10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin~          Hospital, Shanghai, China.~   "
5080|NCT02990728|"~     Primary objective To discover the efficacies of levonorgestrel-containing intrauterine~     device (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for~     grade 1 endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial~     invasion on image study (MRI preferred).~      Secondary objectives~        1. To discover the morphological and molecular change in the endometrium tumor before and~          after treatment~        2. To discover the effectiveness of adding oral progestin to subjects who show no good~          response to assigned~        3. To compare (1) the systemic effects, including body weight change, neuropsychiatric~          alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic~          markers between the two study patient groups; (2) The rate of long-term success defined~          as (a) sustained remission of >= 12 months starts from the histologic documentation of~          complete remission (b) rate of pregnancy and (c) alive baby delivery, based on~          time-to-event analysis.~        4. Molecular markers and their expression before, during and after treatment, including~          progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its~          related markers, Bcl2 and its related markers and other developing markers. This is to~          discover prediction markers to medical treatment.~   "
5081|NCT02990715|"~     The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in~     providing structural information on colonic polypoid lesions and masses, as an adjacent tool~     to FIT.~   "
5082|NCT02990702|"~     The retroclavicular approach for brachial plexus anesthesia requires an optimal angle~     between the needle and the ultrasound beam. Retroclavicular approach has already been proven~     effective and safe in the past. The general objective is to provide a formal comparison~     between the retroclavicular approach and coracoid infraclavicular approach for brachial~     plexus anaesthesia. This study should represent the differences between the two techniques.~   "
5083|NCT02990689|"~     The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal~     IOL for far, near and intermediate vision.~   "
5084|NCT02990676|"~     Cognitive impairments, especially deficits of executive function, have been well documented~     as a core and early feature in Huntington's disease (HD). Cognitive impairments can be~     considerably burdensome and devastating for people and families affected by HD. Computerised~     cognitive training interventions that focus on improving executive function present a~     potentially exciting non-pharmacological treatment option. Novel work conducted in mouse~     models of HD, has demonstrated that cognitive training, administered from an early stage in~     the disease, can improve motor performance at an older age, even in the absence of further~     training in the intervening time. This represents proof of principle in an animal model of~     HD that cognitive training can improve HD disease symptoms.~      Improvements associated with executive function training have also been reported in a~     clinical setting in a variety of neurodegenerative diseases. For example, cognitive~     training, can improve executive function as people age, and training specifically focused on~     tasks of executive function has been shown to improve both cognitive and motor outcomes in~     neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD).~     Therefore, this study is a feasibility study which aims to establish proof of principle for~     using computerised cognitive training in people with HD. The investigators propose to~     determine the feasibility, acceptability and gather preliminary evidence of the~     effectiveness of a cognitive training intervention programme, targeted for people with HD.~     The investigators will also aim to investigate the most appropriate outcome measures to use~     in this study and gather feedback on the cognitive training intervention. The investigators~     will also establish proof of concept via the study of brain structure and function, using~     MRI scanning techniques.~      The computerised cognitive training software and the associated outcome measures will be~     investigated, taking into account the views of people and families who are affected by HD. A~     randomised feasibility study of computerised cognitive training for people with HD will then~     be conducted. Participants who are randomised to the cognitive training intervention group~     will be asked to complete a cognitive training intervention utilising HAPPYneuron~     software. Participants in the intervention group will be asked to complete the cognitive~     training programme for a minimum of 30 minutes, 3 times a week for the 12 week study~     duration. Participants in the control group will not receive any cognitive training and will~     be asked to continue as normal, however they will have home visits to control for the~     confounding effect of social interaction. Additional monitoring and prompting for the~     intervention group, will be conducted via email, text or telephone reminders (as preferred~     by the participant) and home visits. The motor and cognitive function of participants will~     be assessed at the beginning and end of the study, using a range of motor and cognitive~     assessments. Additional cognitive measurements will be recorded as part of the HAPPYneuron~     programme throughout the cognitive training intervention, such as accuracy and response time~     measures of particular computer games. MRI scans (optional) will be conducted at the~     beginning and end of the study to identify any structural changes in the brain that may be~     associated with the cognitive training intervention. As part of the feasibility and~     acceptability assessment, participants, family members and carers will be invited to~     complete a semi-structured interview at the end of the study, if consent is obtained,~     focusing on using this type of software as a home based therapeutic intervention.~   "
5085|NCT02990663|"~     High blood pressure is common and its presence increases the risk of cardiovascular~     mortality and morbidity (most notably stroke, myocardial infarction, and congestive heart~     failure). Given blood pressure is normally higher during the day than it is overnight, blood~     pressure lowering medications are traditionally taken in the morning. However a randomized~     trial of 2156 Spanish hypertension patients published in 2010 (MAPEC), suggests a large~     (61%) reduction in mortality and cardiovascular morbidity if such medications are instead~     taken at bedtime. This degree of benefit far exceeds other established methods of~     cardiovascular risk reduction - and such a surprisingly large effect requires independent~     confirmation for practice to change. BedMed is a pragmatic randomized controlled trial~     (target N = 8750) facilitated by over 300 Canadian family physician members of the Pragmatic~     Trials Collaborative. During the conduct of this trial consenting hypertensive primary care~     patients, already established on one or more antihypertensive medications, will be~     randomized to either morning or bedtime antihypertensive use. Patient oriented trial~     outcomes evaluating both potential benefits and harms will be drawn largely from~     administrative health data that is routinely collected on all residents of Canada's publicly~     funded health care system. This trial is event driven (ending upon the occurrence of 406~     primary outcome events) and expected to run over a period of roughly 3 years.~   "
5086|NCT02990650|"~     Using a randomized controlled research design, compare walking outcomes resulting from gait~     and balance training with standard physical therapist interaction versus training with the~     addition of a KineAssist® robotic system that provides for safety and freedom of movement.~   "
5087|NCT02990637|"~     The purpose of this study is to investigate the effects of daily supplementation of OLECOL~     for a period of 8 weeks on cardiovascular risk markers.~   "
5088|NCT02990624|"~     Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological~     diseases, including psoriasis. The systemic effects of UV phototherapy are still not well~     studied. There are several factors that may affect patient's cardiovascular (CV) risk during~     UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be~     frequently associated with psoriasis. In this study the investigators aim at studying the~     effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with~     psoriasis with or without atherosclerosis.~   "
5089|NCT02990611|"~     Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in~     Patients with Advanced (Unresectable or Metastatic) Melanoma~   "
5090|NCT02990598|"~     To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a~     single dose to lactating women~   "
5091|NCT02990585|"~     This study will be a comparative design between 2 groups of subjects attending classes on~     back education in an urban setting. Participants will be randomized to either an individual~     one-on-one back school session or to the 8 group sessions.~   "
5092|NCT02990572|"~     The purpose of this registry is to find members of the Plain Community who are interested in~     participating in future medical research studies. Having a registry makes it easier to~     contact and offer study participation to individuals who are appropriate for a new research~     study based on their own and their family medical history. Studies will focus on increasing~     knowledge about disorders affecting those who are Amish and Mennonite.~   "
5093|NCT02990559|"~     This pilot study is designed to investigate (1) whether getting iron treatment affects iron~     in the brain and (2) how getting iron treatment affects brain functions when it is~     performing specific cognitive tasks. By cognitive tasks, it means tasks that involve~     perceiving, representing, or assessing things. The specific cognitive tasks used here will~     involve tests of memory and processing speed.~   "
5094|NCT02990546|"~     The aim of this study is to investigate the role of oral midodrine in the recovery of septic~     shock. The investigators hypothesize that the oral drug can reduce central line days and ICU~     length of stay.~   "
5095|NCT02990533|"~     The goal of this study is to collect preliminary data on the efficacy of interventions to~     enhance recovery from hospitalization in community dwelling older adults.~   "
5096|NCT02990520|"~     The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia~     at admission to the hospital in older adults.~   "
5097|NCT02990507|"~     An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates~     arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this~     study is to examine participant perspectives regarding the virtual interface and exercise~     device combination with regard to usability, comfort, safety, rating of perceived exertion,~     and enjoyment.~   "
5098|NCT02990494|"~     Making healthy food choices requires sacrificing immediate pleasures of consuming high~     calorie foods in order to achieve long-term health goals. Two strategies to encourage such~     future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods,~     and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel~     behavioral weight loss (BWL) interventions will be developed based on these strategies~     (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their~     feasibility and efficacy in changing food choice decision-making, reducing food cravings,~     and ultimate weight loss.~   "
5099|NCT02990481|"~     1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs)~          of TRK-950 as single agent~        2. To establish the dose of TRK-950 recommended for future phase 2 studies~   "
5100|NCT02990468|"~     This is a Phase 1a-b study of newly diagnosed patients with biopsy-proven head and neck~     cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment~     with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce~     radiation-induced mucositis and xerostomia and also has the potential to benefit the~     survival of head and neck cancer patients. In Phase 1a, safety and tolerability of BMX-001~     will be assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose~     (MTD) will be determined. BMX-001 will be given subcutaneously first with a loading dose~     zero to four days prior to the start of chemoradiation and followed by twice a week doses at~     one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase~     1b both safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia~     will also be assessed. A maximum of 48 patients will be enrolled to the MTD dose determined~     in Phase 1a to confirm the MTD. The investigators hypothesize that BMX-001 when added to~     standard radiation therapy and cisplatin will be safe at pharmacologically relevant doses in~     patients with newly diagnosed head and neck cancer. The investigators also hypothesize that~     in Phase 1b of this study the addition of BMX-001 will reduce the severity of~     radiation-induced mucositis and xerostomia in patients receiving head and neck radiation~     therapy.~   "
5101|NCT02990455|"~     The proposed research will investigate whether smokers with vs. without current alcohol use~     disorder (AUD) respond to reduced nicotine cigarettes by increasing their alcohol~     consumption or smoke exposure, thereby diminishing the hypothesized public health benefit of~     these new products.~   "
5102|NCT02990442|"~     Forensic patients will undergo 30 rTMS treatments, once per day each business day using a~     1Hz frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3.~     Patients will be assessed before and after the study with a battery of assessments and using~     2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP).~     The investigators will also monitor and record aggressive incidents that take place on the~     unit.~   "
5114|NCT02990286|"~     The purpose of the study is to evaluate the efficacy on lung function 6 months after one~     course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one~     course of placebo and 6 months of MMF treatment in a broad range of ILD patients~     non-responders to a first line immunosuppressive treatment.~   "
5286|NCT02988102|"~     In pediatric age groups communication difficulties very sometimes may present further~     obstacles in obtaining a detailed injury history and early identification of TBI symptoms.~      Most emergency management protocols are focused exclusively on the identification of the~     relatively small number of patients who may require operative intervention, as early surgery~     is believed to improve outcome.~   "
5103|NCT02990429|"~     Perioperative hypothermia is a common problem. It has been defined as a core temperature~     below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has~     perioperative hypothermia because the reduced metabolic heat production, redistribution of~     heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use~     of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat~     loss due to the cool environment. This perioperative problem has been linked to adverse~     patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine,~     surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy~     as hypothermia impairs platelet function.~      It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and~     evaporation (10%). This is caused by the difference between peripheral body and ambient~     temperature, air circulation around the body and vasodilatation.~      In daily practice, most anesthesia personnel warm patient peri-operatively by using force~     air warmer and intravenous fluid warmer.~      This study aimed to compare the difference of core and room temperature in patients~     undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer~   "
5104|NCT02990416|"~     This study evaluates the effectiveness of adding a single four-day treatment of the fusion~     protein A-dmDT390-bisFv(UCHT1) — plus single palliative tumor radiation — with standard of~     care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results~     will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.~   "
5105|NCT02990403|"~     In this clinical cohort study, the investigators are going to observe the efficacy of~     anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a~     prospective randomized controlled trial.~   "
5106|NCT02990390|"~     RSA is a multifactorial disorder resulting from genetic factors, anatomic factors,~     autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal~     infections. However, the underlying causes remain undetermined in up to 50% of cases. In~     this clinical cohort study, we intended to get an epidemiological evidence for patients with~     recurrent spontaneous abortion associated with thrombophilla.~   "
5107|NCT02990377|"~     In recent years in the U.S., problems associated with opioid prescriptions, including~     non-medical use and overdose, increased to historically unprecedented levels and represent a~     public health crisis. Emergency departments (EDs) play an important role in opioid~     prescribing, particularly to individuals at high risk for adverse opioid-related outcomes.~     The purpose of this study is to determine whether a new mobile health (mhealth) intervention~     can assist people in the safe use of opioid analgesic (OA) medications after leaving the~     emergency department (ED).~      The specific aims of this project are to: (1) adapt and enhance an existing motivational~     intervention to decrease non-medical opioid use after an ED visit by optimizing intervention~     intensity and duration through reinforcement learning (RL); (2) examine the impact of an~     RL-supported intervention on non-medical opioid use level during the six months post-ED~     visit; and (3) examine the impact of the RL intervention on the opioid-related behaviors and~     adverse outcomes of driving after opioid use, overdose risk behaviors, and subsequent~     opioid-related ED visits. The secondary aims of this project are to: (SA1) examine whether~     baseline level of non-medical opioid use moderates the effects of the intervention; and~     (SA2) understand barriers and facilitators of implementation of the intervention based on~     qualitative interviews with ED patients.~   "
5108|NCT02990364|"~     Circumcision is a commonly performed procedure on newborn males. Clear recommendations~     and/or guidelines for pain control during the procedure do not exist. The purpose of this~     research is to compare various forms of analgesia to evaluate which is the more effective~     for pain reduction. The investigators hope that this study can provide definitive guidelines~     on the best form of analgesia to use during circumcision. It is important that we perform~     this study to ensure that in the future newborns' pain during circumcision is effectively~     managed.~   "
5109|NCT02990351|"~     This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver~     Transplantation in patients with HCC.~   "
5110|NCT02990338|"~     Primary Objective:~      To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose~     dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to~     pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and~     refractory multiple myeloma (MM).~      Secondary Objectives:~        -  To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group~          (IMWG) criteria in each arm.~        -  To compare the Overall Survival (OS) between the two arms.~        -  To evaluate the Time To Progression (TTP) in each arm.~        -  To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in~          each arm.~        -  To evaluate the Duration of Response (DOR) in each arm.~        -  To evaluate the safety in both treatment arms.~        -  To determine the Pharmacokinetic profile of isatuximab in combination with~          pomalidomide.~        -  To evaluate the immunogenicity of isatuximab.~        -  To assess disease-specific and generic health-related quality of life (HRQL), disease~          and treatment-related symptoms, health state utility, and health status.~   "
5111|NCT02990325|"~     The purpose of the ABX464-005 study is to characterize the systemic and mucosal~     immunological sequelae associated with exposure to ABX464 and to explore selected~     immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.~   "
5112|NCT02990312|"~     The purpose of this proof of concept, pilot study is to determine whether the unique~     combination of the human immunodeficiency virus (HIV) co-receptor antagonist, Maraviroc, and~     the mammalian target of rapamycin (mTOR) inhibitor, Sirolimus, in HIV-infected kidney~     transplant recipients has an impact on chemokine receptor 5 (CCR5) density, the~     HIV-reservoir, or rejection of the transplanted kidney. 15 HIV-infected kidney transplant~     recipients will be recruited and their immunosuppressant regimen will be changed to include~     an mTOR inhibitor (such as Sirolimus) unless they are already on one. In addition, Maraviroc~     will be added to their HIV regimen, unless they are already on Maraviroc. Blood will be~     taken to measure markers of the HIV reservoir, their CCR5 density and expression, and immune~     activation.~   "
5113|NCT02990299|"~     The purpose of this research study is to determine the benefit and cost of including health~     coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and~     videoconferencing in diabetes management support services for African-Americans and Latinos~     with uncontrolled Type 2 Diabetes.~   "
5115|NCT02990273|"~     Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting~     in rebalanced homeostasis. However, conventional blood tests (platelets/ INR levels) that~     are performed prior to invasive procedures do not accurately reflect the coagulation changes~     that occur in cirrhotics, resulting in unnecessary transfusion of blood products.~     Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in~     surgery (including liver transplant) to help guide blood product transfusion in the~     operating room. The investigators would like to compare the use of TEG vs. INR/platelets to~     help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy.~     The investigators will evaluate to see if there is a decrease in prophylactic blood~     transfusions prior to endoscopy when using TEG.~   "
5116|NCT02990260|"~     The aim of the study is to evaluate the effect of the consumption of a food supplement (live~     saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.~   "
5117|NCT02990247|"~     Asthma exacerbations account for a significant morbidity and disproportionate health care~     costs. However, there is no currently available biomarker or lung function parameter that~     can accurately predict the risk of future exacerbations. The current work aims at evaluating~     the resting ventilatory flow by applying a new technique called anharmonic morphological~     analysis of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is~     potentially able to detect an increased risk of asthma exacerbations.~   "
5118|NCT02990234|"~     The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular~     Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient~     outcomes in the short, mid and long term, both clinically and radiographically, compared to~     those without capsular repair. The objective of this clinical trial is to evaluate the~     clinical efficacy with regards to pain, range of motion and return to work and activities of~     daily living. Secondary objective is to evaluate radiographic characteristics between both~     groups.~   "
5119|NCT02990221|"~     The main objective of this study is to compare the effectiveness of ingenol mebutate gel~     (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or~     scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of~     each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the~     treatment of actinic keratosis and their field cancerization.~      Study details:~      This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II,~     located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the~     inclusion criteria will be enrolled in the study by the investigators in the three different~     centers mentioned above.~      The investigators will assess the effect of treatment by confocal microscopy and digital~     dermoscopy. The investigator will acquire images of selected areas of the face and scalp~     before and after treatment. Data will be collected and analyzed by the coordinating centre.~      Procedure for the study:~      Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150~     micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited;~     evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The~     measurements will be carried out at time 0, after 1 month and 6 months. The investigator~     must fill out a form for each subject at the beginning (day 0), after 1 month and at the end~     of the study (after 6 months). The subject must complete a questionnaire at the beginning~     (day 0), after 1 month and at the last follow-up visit (after 6 months).~      Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the~     percentage reduction in actinic keratoses and the damage of the cancerous area in the two~     selected areas treated with ingenol mebutate gel or cryotherapy, respectively.~      Adverse / side events will be collected at each visit by the investigator and will be~     contained in another form.~   "
5120|NCT02990208|"~     The study investigated the effect of diaphragmatic breathing as an additional coping~     strategy during Virtual Reality Exposure Therapy in patients with aviophobia. The authors~     assumed that diaphragmatic breathing (DB) would lead to less fear and physiological arousal~     during the VRET and to an enhanced treatment outcome~   "
5121|NCT02990195|"~     Multicentre prospective human experimental study to determine the effect of chyme reinfusion~     in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)~   "
5122|NCT02990182|"~     In a previous study by the researchers' group, the researchers' investigate the duration of~     yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of~     age. However, in this study, samples of children in the pre-vaccine period, also known as~     unvaccinated children samples (NV) have not been investigated. It is believed that to seek~     evidence about the immune status in the medium and long term after vaccination against~     yellow fever is necessary to investigate paired samples of children not vaccinated (NV),~     with re-evaluation 30-45 days after primary vaccination. The proposed study is to~     consolidate aspects of humoral (neutralizing antibodies) and cellular (phenotypic and~     functional parameters of T cells and memory B) by means of complementary longitudinal~     investigation children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary~     vaccination.~   "
5123|NCT02990169|"~     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical~     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure~     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism~     (GAT). Fifty (50) Subjects 18 and older and will be enrolled. Subjects will be screened~     based on standard of care vision examination at the clinical investigation sites. All~     subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured~     using a Goldmann tonometer armature with both the standard flat GAT prism and the modified~     curved CATS prism alternately inserted. The only additional measurement is central corneal~     thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in~     the GAT prism and is currently standard of care.~   "
5124|NCT02990156|"~     The scope of this trial is the collection and analysis of effectiveness and safety~     endpoints, related to the use of the MicroPort NeuroTech Coil Embolization System in the~     treatment of intracranial aneurysms.~   "
5125|NCT02990143|"~     The purpose of this study is to investigate whether placing Ologen over the posterior plate~     of the Ahmed glaucoma drainage device during initial implantation will allow the formation~     of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during~     the postoperative period.~   "
5126|NCT02990130|"~     This proposal aims to characterize biochemical and physiologic factors that contribute to~     changes in patient fitness and body composition during hematopoietic stem cell~     transplantation (HCT) for hematologic malignancies. The study group will consist of 60~     patients with hematologic malignancies treated with HCT. Measurements of patient fitness,~     body composition, and inflammatory milieu will be performed at visits before HCT, and 30~     days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA,~     additional visits (not exceeding 6 total) may be requested periodically for up to 2 years~     after HCT.~   "
5823|NCT02980952|"~     The aim is to assess the impact of physical inactivity on muscle amino acid balance. In~     addition, we will evaluate how the diet and/or a pharmacological intervention designed to~     manipulate lipid metabolism (acipimox) will modulate muscle amino acid balance.~   "
5127|NCT02990117|"~     The introduction of inhaled medication as the primary treatment for asthma has led to~     substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still~     common and represents a considerable burden to patients and society [3, 4]. An important~     reason for poor asthma control and consequently, increased healthcare expenditure is~     suboptimal adherence to the prescribed regimen [5-7].~      Real-world market research study in hospitals across China reported that physicians~     perceived that only 23% of patients were fully compliant with their medication regime (77%~     non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal~     document]. The physician reported rate of full adherence was lower than the patient-reported~     rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of~     physicians) when treating an asthma.[8]~      However~      There is some evidence on the drivers of patient behaviour around low adherence but more~     depth research is needed~      There is little evidence on variation of determinants of asthma inhaled treatment across~     different age of group~      Our research aims to address above data gap Mean while this research can guide the~     development of new module on Red Scarf patient education program.~   "
5128|NCT02990104|"~     The purpose of this study is to describe the incidence, clinic characteristics, biological~     and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.~   "
5129|NCT02990091|"~     This is a Phase 2 clinical trial designed to obtain data on relationships between~     potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their~     bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on~     clinical outcomes after TBI.~   "
5130|NCT02990078|"~     The investigators will longitudinally measure cerebrovascular reactivity (CVR) by functional~     near-infrared spectroscopy (fNIRS) in acute (≤3 days from injury), subacute, and chronic~     phases after TBI as a biomarker of TCVI as compared to healthy controls. CVR will be~     measured by fNIRS response to hypercapnia. The investigators hypothesize that CVR will be~     decreased after TBI and that these decreases will correlate with clinical outcomes.~     Furthermore, the investigators predict that administration of a vasodilatory medication~     (sildenafil) will augment CVR after TBI.~   "
5131|NCT02990065|"~     The purposes of the study are:~        -  To strictly ensure the appropriate level of protein and caloric provision in critical~          illness, according to the latest literature recommendation;~        -  To determine if an association exists between protein intake and nitrogen balance in~          the context of a nutrition with appropriate protein provision based on the latest~          literature recommendations, rather than in a standard diet with a caloric target~          weight-based. Creatinine clearance will also be evaluated to determine if there is any~          harmful effect to the kidney secondary to an elevated BUN.~        -  To determine if there is a difference in ICU mortality rate between the current~          nutrition standard and a hyperproteic nutrition protocol.~   "
5132|NCT02990052|"~     A prospective, randomized controlled single-center trial with 80 patients aged 50 years and~     above to compare the functional and radiological results of conservative treatment and volar~     fixed-angle plating in the management of distal radius fracture~   "
5133|NCT02990039|"~     The purpose of this study was (i) to develop a brief counseling letter intervention aiming~     to reduce sedentary time and to increase physical activity during leisure time among adults~     aged 42 to 64 years and (ii) to provide information on the feasibility.~   "
5134|NCT02990026|"~     Specialty mental health probation for offenders with severe mental illness has been widely~     disseminated; however, randomized studies are needed to determine its effectiveness. The~     purpose of the study is to test the feasibility and efficacy of specialty mental health~     probation (SMHP) for probationers with mental illness in North Carolina. 320 adult~     probationers with mental illness in will be randomly assigned to specialty mental health~     probation (experimental condition) or usual probation (control condition). Probationers~     assigned to the experimental condition will be supervised by specialty mental health~     probation officers, who will have reduced caseloads and advanced training in mental health~     and other topics. Probationers assigned to the control condition will receive standard~     probation. Criminal justice and mental health outcomes will be examined.~   "
5135|NCT02990013|"~     Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome~     on human skin~      Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol~     against AvenovaTM as a sterile skin agent~   "
5136|NCT02990000|"~     Research has shown that mental health care (MHC) providers differ significantly in their~     ability to help patients. In addition, providers demonstrate different patterns of~     effectiveness across symptom and functioning domains. For example, some providers are~     reliably effective in treating numerous patients and problem domains, others are reliably~     effective in some domains (e.g., depression, substance abuse) yet appear to struggle in~     others (e.g., anxiety, social functioning), and some are reliably ineffective, or even~     harmful, across patients and domains. Knowledge of these provider differences is based~     largely on patient-reported outcomes collected in routine MHC settings.~      Unfortunately, provider performance information is not systematically used to refer or~     assign a particular patient to a scientifically based best-matched provider. MHC systems~     continue to rely on random or purely pragmatic case assignment and referral, which~     significantly waters down the odds of a patient being assigned/referred to a high~     performing provider in the patient's area(s) of need, and increases the risk of being~     assigned/referred to a provider who may have a track record of ineffectiveness. This~     research aims to solve the existing non-patient-centered provider-matching problem.~      Specifically, the investigators aim to demonstrate the comparative effectiveness of a~     scientifically-based patient-provider match system compared to status quo pragmatic case~     assignment. The investigators expect in the scientific match group significantly better~     treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with~     treatment. The investigators also expect to demonstrate feasibility of implementing a~     scientific match process in a community MHC system and broad dissemination of the easily~     replicated scientific match technology in diverse health care settings. The importance of~     this work for patients cannot be understated. Far too many patients struggle to find the~     right provider, which unnecessarily prolongs suffering and promotes health care system~     inefficiency. A scientific match system based on routine outcome data uses patient-generated~     information to direct this patient to this provider in this setting. In addition, when based~     on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be~     represented (e.g., symptom domains, functioning domains, quality of life).~   "
5137|NCT02989987|"~     Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most~     effective, culturally sensitive trauma interventions. In the present study the effectiveness~     of NET delivered by trained health personnel in a sample of survivors of sexual and gender~     based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.~     Structured baseline, 3 and 6 month follow up interviews will be administered to assess the~     main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where~     SGBV and its sequelae has been a major problem.~   "
5897|NCT02979990|"~     The Learning from Online Video Education (LOVE) study seeks to determine if online~     instructional videos on how to administer medication needed for in vitro fertilization (IVF)~     help improve the quality of life and reduce stress during the IVF process.~   "
5138|NCT02989974|"~     The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop,~     administer and evaluate the impact of a comprehensive psychosocial survivorship care program~     for individuals diagnosed with lung cancer and their caregivers to improve lung cancer~     survivorship and delivery of high-quality lung cancer care. The investigators hypothesize~     that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved~     quality of life, better symptom control, increased tobacco treatment, and reduced distress~     among lung cancer survivors and their caregivers.~   "
5139|NCT02989961|"~     The purpose of this study is to determine the safety and effectiveness of Resticutis for the~     treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Rich and~     Platelet-Poor Plasma preparations.~   "
5140|NCT02989948|"~     A prospective, single-arm, traditional feasibility study of a physician-modified fenestrated~     Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size~     criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting~     surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be~     eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse~     events will also be recorded by the Sponsor-Investigator and will be monitored by a locally~     appointed Data Monitoring Committee, the Colorado Multiple Institutional Review Board, and~     the FDA.~   "
5141|NCT02989935|"~     This study examines the effect of the ultra long acting beta agonist/corticosteroid~     bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory~     muscles and ventilation in adults with severe bronchitis or emphysema (COPD).~   "
5142|NCT02989922|"~     This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210~     in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The~     primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and~     Overall Survival when compare with SOC.~   "
5143|NCT02989909|"~     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical~     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure~     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism~     (GAT).~      Of the 150 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in~     the low, medium and high IOP ranges shall have the same clinical testing and analysis of~     results, with the analysis kept separate from that of the main group.~   "
5144|NCT02989896|"~     After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in~     local vasodilatation, increased local blood flow, and increased skin temperature.Increased~     permeability index; Can be used as a reliable tool for evaluating block activity.~   "
5145|NCT02989883|"~     Esophageal outflow obstruction is characterized by failure to relax the lower esophageal~     sphincter (LES), resulting in impaired flow of ingested food into the stomach. The~     subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest~     pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction~     is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic~     options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon~     dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy~     myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there~     have a few studies regarding long-term outcomes. The aim of this study is to evaluate~     clinical outcomes of POEM for esophageal outflow obstruction.~   "
5146|NCT02989870|"~     This study involves a course of radiation to up to 5 tumors in the participant's liver~     followed by systemic therapy. (Treatment using substances that travel through the~     bloodstream, reaching and affecting cells all over the body.) The type of radiation is~     called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare~     the effects, good and/or bad, of different doses of SBRT given along with the systemic~     therapies, sorafenib and bavituximab. The researchers want to see which dose of radiation~     will work best in stimulating the immune response and provide local control to the~     participant's liver. The usual treatment for hepatocellular carcinoma that is unresectable~     can be transarterial therapy, sorafenib alone and/or clinical trial.~   "
5147|NCT02989857|"~     Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled~     study of orally administered AG-120. Subjects, all personnel involved in the evaluation of~     subjects' response to treatment (e.g., Investigators, study coordinators, study~     pharmacists), and designated Sponsor team members will be blinded to study treatment.~     Subjects are required to have a histologically-confirmed diagnosis of IDH1 gene-mutated~     cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative~     therapies prior to enrollment.IDH1 mutation testing will be performed at participating~     investigative sites. Subjects must have progression of disease and have received at least 1~     but not more than 2 prior treatment regimens for advanced disease (nonresectable or~     metastatic). All subjects must have received either a gemcitabine or a 5 fluorouracil (5-FU)~     based chemotherapy regimen.~   "
5148|NCT02989844|"~     This is a multi-center, phase II clinical trial to prevent relapse using interleukin-15~     (IL-15) super-agonist complex (ALT-803) maintenance after allogeneic hematopoietic cell~     transplantation (alloHCT) in acute myelogenous leukemia (AML) and myelodysplastic syndrome~     (MDS).~   "
5149|NCT02989831|"~     The purpose of this study is to investigate the effects of vibrating insoles on vibration~     perception threshold (VPT) and balance of people with diabetic neuropathy.~   "
5150|NCT02989818|"~     The aim of this multi-center study is to prospectively document the clinical utility of ESD.~   "
5171|NCT02989545|"~     Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months~     and is a devastating disease. The negative impact on quality of life has been consistently~     demonstrated. The prevalence of FI is probably underestimated in most studies. Currently~     conservative treatment is only modestly effective and surgical treatment is complex and~     expensive with less than optimal efficacy.~      The investigators developed an anal tape using a commercially available elastic band with~     a special adhesive that is approved for use in the skin. A special design of the tape can be~     applied to the skin surrounding the anus providing support and additional pressure forces to~     the anal sphincter.~      This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and~     safety of this device in patients with FI. The primary endpoint will be improvement in~     quality of life.~   "
5151|NCT02989805|"~     This study will compare the effectiveness of professional and peer care managers in~     improving linkage to and engagement in outpatient care after an emergency department (ED)~     discharge, as well as the mechanisms by which engagement occurs. The study will use a~     multi-site randomized trial study design across 8 EDs in South Carolina with telepsychiatry~     programs; each site will have one professional care manager (social worker or nurse) and one~     peer specialist care manager. Eligible subjects at each site will be randomized to a~     one-year treatment engagement intervention, the Coordination, Access, Referral and~     Evaluation (CARE) Program with either a peer or professional care manager, resulting in a~     total of 1000 participants across sites. The CARE program will focus on shared~     decision-making between care managers and patients, and combines the traditional medical~     model of care management with a recovery-based approach. Follow-up interviews at baseline, 6~     months and 12 months will assess outpatient treatment engagement after discharge from the~     ED, changes in mental health and clinical outcomes, and changes in attitudinal and~     logistical barriers to obtaining services.~   "
5152|NCT02989792|"~     Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling~     for genotyping purposes. In addition they will compete the personality questionnaires they~     had completed in the former trial.~   "
5153|NCT02989779|"~     Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind~     placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and~     Modified Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI~     before the trial begins. Patients receive either one week of the drug or one week of placebo~     and perform the same tasks and assessments. Then patients receive another week of the~     alternate pill, followed by another round of tasks during MRI and assessments.~   "
5154|NCT02989766|"~     This intervention would be a series of self-help-style educational and motivational activity~     sheets for patients to complete independently. This will be a randomized clinical control~     trial.~      Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects~     in the intervention arm will complete 3 activity sheets prenatally during their wait time at~     the clinic. The first worksheet can be completed the day of recruitment after consent is~     signed.~      Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term~     duration of breast feeding.~   "
5155|NCT02989753|"~     This study is designed as a pilot study in order to estimate the effect of VAL070-A and~     VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these~     data are still unknown for these products and in this specific population. Collected data~     will provide more reliable information which may be used to plan a subsequent larger main~     study.~   "
5156|NCT02989740|"~     Title:~      Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic~     Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes~     Mellitus Patients COMBINE (OCT-FFR) Prospective Register~      To study the natural evolution of patients with at least one intermediate angiographic but~     non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no~     TCFA as detected by OCT imaging and to compare these two groups of patients with each other~     as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on~     future MACE.~   "
5157|NCT02989727|"~     The purpose of this study is to determine if patients with melancholic bipolar II depression~     are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.~     To do this, the investigators will re-analyze a previous clinical trial that evaluated~     lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).~   "
5158|NCT02989714|"~     This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High~     Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days~     apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in~     combination with Nivolumab.~      Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the~     anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate~     that the combination of the two therapies would result in an increase in the overall~     response rate, complete response rate, and improved survival outcomes compared to either of~     the individual therapies.~   "
5159|NCT02989701|"~     Sickle cell disease (SCD) is one of the most common genetic diseases in the world. In North~     America, an estimated 2600 babies are born with SCD each year1, and approximately 70,000 to~     100,000 individuals of all ages are affected in the United States2. The clinical~     manifestations of SCD include acute events, such as recurrent debilitating painful crises,~     as well as life-threatening pulmonary, cardiovascular, renal, and neurologic complications.~     The only established curative treatment for SCD patients is allogeneic hematopoietic stem~     cell transplant (HSCT). Unfortunately, access to this intervention is limited by~     availability of suitable matched donors, and HSCT is associated with significant morbidity~     and mortality. For patients who cannot undergo HSCT, treatment of SCD has been limited to~     one FDA-approved medication, hydroxyurea, and supportive symptomatic care. After decades~     with very few novel therapeutic options for SCD patients, autologous cell-based genetic~     therapies, including lentiviral-based gene therapy as well as gene editing, now offer the~     possibility of innovative curative approaches for patients lacking a matched donor for~     hematopoietic stem cell transplantation.~      Gene therapy for sickle cell disease is increasingly promising, and there are currently open~     clinical trials at several centers that employ a gene addition strategy.~      Options for autologous HSC collection include bone marrow harvest or peripheral blood HSC~     mobilization. Bone marrow (BM) harvest is an invasive procedure requiring anesthesia, which~     is associated with sickle cell-related morbidities, and may not achieve goal CD34+ cell~     dose, necessitating repeated procedures scheduled over multiple months. In most gene therapy~     trials, HSCs are obtained through peripheral collection after mobilization with granulocyte~     colony-stimulating factor (G-CSF) followed by peripheral blood (PB) apheresis. However, this~     approach is contraindicated in SCD because G-CSF has been reported to cause severe adverse~     effects in sickle cell patients. Even with doses sometimes smaller than standard, G-CSF has~     been shown to result in vaso-occlusive crises, severe acute chest syndrome, and in one~     report, massive splenomegaly and death. Alternative options for mobilization are needed.~      Plerixafor has been compared to G-CSF in a sickle cell mouse model, and results showed~     effective mobilization of HSC subsets, without neutrophil or endothelial activation, and~     with lower total WBC and neutrophil counts compared to G-CSF-treated mice. Plerixafor use~     has not yet been documented in sickle cell patients. One other trial is currently open to~     test plerixafor in SCD patients (NCT02193191) but no results have yet been reported. Based~     on pre-clinical data, the mechanism of action of plerixafor, as well strategies the~     investigator will employ to mitigate risk, the investigator anticipates that it will be~     well-tolerated in the SCD patient population.~   "
5160|NCT02989688|"~     Patients with kidney, or renal, failure require life-saving treatment with regular dialysis.~     Dialysis is a form of treatment that simulates some kidney functions; to remove harmful~     waste products and extra water from the blood. Almost one-third of people with kidney~     failure also have diabetes, as diabetes is one of the leading causes of kidney disease in~     the United Kingdom, usually due to poor blood sugar control over a long period of time.~     Malnutrition is common in patients needing dialysis due to kidney failure causing fatigue,~     taste changes and a build up of waste products, which can reduce appetite. Treatment of~     malnutrition involves increasing both the energy and protein intake from food and drinks,~     and milk-drink style specialist nutrition drinks are often given to dialysis patients due to~     their specific dietary needs. These nutrition drinks can increase blood sugar levels and~     optimal control for diabetes may be difficult. This research study aims to measure the blood~     sugar response to a slow-release sugar nutrition drink specifically designed for dialysis~     patients, which may result in a lower blood sugar level, compared to standard nutrition~     drinks, consumed during a dialysis session. 28 patients with diabetes and having regular~     dialysis treatment will enrol in the study. Patients will be asked to drink 1 of 3 different~     nutrition drinks, once a week for 3 weeks during their regular dialysis treatment. Blood~     sugar levels will be measured from the blood samples taken from the patient's circulation~     directly before it enters the dialysis machine over 3 hours and the maximum blood sugar~     reading and total blood sugar response will be measured. Differences between the 3 drinks~     will be tested statistically. The results will help to advise patients with diabetes and~     kidney failure on the most suitable type of nutrition drink to consume during dialysis.~   "
5172|NCT02989519|"~     The purpose of this study is to determine efficacy of vaginal and oral progesterone after~     tocolytic therapy in threatened preterm labor~   "
5173|NCT02989493|"~     Double-blind, placebo controlled, randomized controlled trial (RCT) for Alcohol Use Disorder~     examining the effects of doxazosin, a norepinephrine alpha1 receptor antagonist, on stress~     reactivity and clinical outcomes.~   "
5232|NCT02988804|"~     The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the~     incidence of complications is low, hypertensive episodes during surgery and awakening and~     cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or~     vomiting during the early postoperative period must be avoid to protect the patient from CSF~     leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a~     better haemodynamic profile and less incidence of cough in some surgical procedures and it~     could help minimizing the risks after EETS~   "
6803|NCT02968394|"~     The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction~     of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to~     systemic reactions.~   "
5161|NCT02989675|"~     The purpose of this study is to evaluate the impact of dextrose administration in severely~     sick children admitted to hospital with low-glycaemia.~      The problem: Mortality in children remains high in sub-Saharan African hospitals. While~     antimalarial drugs, antibiotics and other definitive treatments are well understood, the~     role of emergency care with supportive therapies such as maintaining normal glucose and~     electrolyte balances, has been given limited attention. Hypoglycaemia is common in children~     admitted to hospital in low-income settings. The current definition of hypoglycaemia is a~     blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a~     mortality rate of up to 42%. An increased mortality has also been reported among acutely ill~     children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason~     for increased mortality rates is not fully understood.~      Study objective: To determine the impact on mortality of a raised treatment cut-off level~     for paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.~      Methodology: Severely ill children admitted to Queen Elizabeth Central Hospital in Blantyre,~     Malawi with low-glycaemia (2.5-5.0mmol/l) will be randomised into intervention or control~     groups. The intervention group will be treated with an intravenous bolus of 10% dextrose~     5ml/kg followed by a dextrose infusion in addition to standard care while the control group~     will receive standard care only. Children will be followed until discharge from hospital or~     death. Primary end-point is in-hospital mortality.~   "
5162|NCT02989662|"~     In alcohol use disorder (AUD) and matched healthy control (HC) men and women, the proposed~     research examines MIFE, with demonstrated preclinical effects on drinking-related behaviors,~     and CORT125134, a newer medication with improved safety profile but as yet unexamined~     efficacy for AUD, on a breadth of alcohol-related measures. All subjects will be randomized~     to daily MIFE, CORT125134 or placebo. Before and during medication, AUD and HC subjects~     undergo fMRI scanning measuring resting-state functional connectivity and alcohol~     cue-induced brain activation focused on brain reward and stress pathways. All subjects are~     admitted to the Clinical Research Unit; AUD subjects undergo supervised alcohol withdrawal~     with daily measurements of alcohol craving and symptom severity. Using validated human~     laboratory procedures in AUD subjects, this study will examine the effects of stress on~     motivation to drink and alcohol sensitivity/reward as a function of GR antagonism.~   "
5163|NCT02989649|"~     The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations~     (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or~     alogliptin FDCs, in standard clinical practice.~   "
5164|NCT02989636|"~     This phase I trial studies the side effects of nivolumab with or without stereotactic~     radiosurgery in treating patients with chordoma that has come back or spread from where it~     started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere~     with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a~     specialized radiation therapy that delivers a single, high dose of radiation directly to the~     tumor and may cause less damage to normal tissue. It is not yet known whether giving~     nivolumab with or without stereotactic radiosurgery may work better in treating patients~     with chordoma.~   "
5165|NCT02989623|"~     This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography~     (PET) works in detecting prostate cancer in patients with persistently elevated prostate~     specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a~     compound made of a radioactive agent attached to a molecule that looks like a hormone that~     binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET~     may be able to see tumors at an earlier stage than the standard of care.~   "
5166|NCT02989610|"~     The purpose of this post market study is to support the chronic clinical performance of the~     Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads,~     extensions and related system components.~   "
5167|NCT02989597|"~     Methadone has several advantages over standard narcotic medications, especially when~     considering use after a typically painful surgery such as lumbar fusion. Methadone is low~     cost, has a long half-life, has a convenient dosing schedule, has excellent oral~     bioavailability, and demonstrates slow onset to withdrawal. The literature comparing~     methadone to more commonly used post-operative narcotics demonstrates that it manages pain~     better, sustains consistent plasma concentrations, decreases overall narcotic requirement,~     results in no additional adverse events, and is safe, even in children, across several~     studies. Since the standard of care is non-methadone narcotic usage to manage the~     significant pain of complex spinal surgery cases, it is understandable that methadone could~     be a desirable alternative to promote sustained pain control and early ambulation in these~     patients. The goal of this study is to compare the effect of a single dose of methadone~     administered intraoperatively in enrolled spinal fusion patients to their historical~     controls given fentanyl and morphine, and determine if more sustained pain control during~     the first few days after surgery provides a better subjective experience for the patient~     with less pain, which allows them to ambulate and leave the hospital sooner than patients~     given a standard regimen.~   "
5168|NCT02989584|"~     The purpose of this study is to test the safety of the study drug, atezolizumab, when~     combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study~     will help researchers begin to understand whether combining GC with atezolizumab is better,~     the same, or worse than the usual approach of using GC alone.~   "
5169|NCT02989571|"~     The objective of this study is to compare the effects of intravenous fluid rate on the~     course of labor in nulliparous patients who are undergoing labor induction and have an~     unfavorable cervix. The primary hypothesis is that an increased rate of intravenous fluids~     will shorten the length of labor in patients undergoing induction with an unfavorable~     cervix.~   "
5170|NCT02989558|"~     Ticagrelor administered with Acetylsalicylic Acid (ASA) will provide better cerebral~     protection from microembolization in the cerebral circulation during Transcatheter Aortic~     Valve Implantation (TAVI) and 30 days afterwards, than Clopidogrel plus ASA. This hypothesis~     will be investigated by measuring the number of High Intensity Transient Signals (HITS) as~     assessed with transcranial Doppler (TCD) on middle cerebral arteries.~   "
5208|NCT02989038|"~     The purpose of this study is to evaluate reactions to, and choices to self-administer,~     cigarette smoke with varying nicotine content among low-frequency, non-dependent~     adolescent/young adult smokers between the ages of 18-25 years.~   "
5174|NCT02989480|"~     Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the~     heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by~     fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it~     affects the heart patches of inflammation can result in scarring, especially of the~     ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis~     can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and~     implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually~     treated with implantable defibrillators. The diagnosis of either condition can be difficult~     and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans~     (PET) are used to identify inflammation in the heart in patients suspected of having cardiac~     sarcoid. It is not known whether patients with ARVC have abnormal PET scans.~   "
5175|NCT02989467|"~     This research study is being done to compare the effects of Aprepitant and placebo on~     fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.~   "
5176|NCT02989454|"~     Acute stress induced (Tako-tsubo) cardiomyopathy (TTC) or broken heart syndrome, a condition~     typically occurring after acute stress has a death rate similar to heart attacks and is~     frequently associated with long-term symptoms (fatigue and exercise limitation). There are~     no effective therapies. The investigators have recently showed that there is a profound~     shortage of energy in the hearts of Tako Tsubo Cardiomyopathy patients in the days after~     acute presentation with only partial recovery by four months. The investigators would now~     like to establish whether this recovers after at least one year, or persists, and also to~     investigate the mechanisms responsible for exercise limitation after recovery from the acute~     phase.~   "
5177|NCT02989441|"~     In patients under general anesthesia the investigators wish to investigate association and~     covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo,~     Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure~     and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)~   "
5178|NCT02989428|"~     The aim of this study is to establish whether patients with mild primary hyperparathyroidism~     (PHPT) have an increased risk of cardiovascular diseases. The primary outcome is to~     determine whether arterial stiffness and blood pressure will decrease in patients with mild~     PHPT 3-month after parathyroidectomy (PTX).~   "
5179|NCT02989415|"~     The aim of this study is to assess the incidence of postoperative pulmonary complications in~     patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to~     characterize current practices of mechanical ventilation and to evaluate a possible~     association between ventilatory parameters and postoperative pulmonary complications.~   "
5180|NCT02989402|"~     This is a multicenter, prospective, phase IV study evaluating safety, tolerability and~     effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with~     severe dementia of the Alzheimer's type as per discretion of treating physician.~   "
5181|NCT02989389|"~     The main purpose of this study is to investigate the safety of LY3323795 and the effects it~     has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy~     participants. The study has three parts. Each participant may only enroll in one part. The~     study will last 14 to 43 days, depending on the part. Screening must be completed prior to~     study start.~   "
5182|NCT02989376|"~     The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular~     imaging for selecting acute stroke patients for endovascular thrombectomy.~   "
5183|NCT02989363|"~     Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS)~     surgeries and complex back surgeries~   "
5184|NCT02989350|"~     Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral~     rehydration therapy is the key treatment. According to the 2014 guidelines developed by the~     ESPGHAN probiotics may be considered in the management of children with AGE in addition to~     rehydration therapy. Considering that evidence on L reuteri remains limited, the~     investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in~     children. Children vaccinated and not vaccinated against rotavirus will be evaluated~     separately.~      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.~   "
5185|NCT02989337|"~     The purpose of the study is to determine serum inflammatory adhesion molecules levels in~     hyperemesis gravidarum~   "
5186|NCT02989324|"~     Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second~     Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections~   "
5187|NCT02989311|"~     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia~     (IDA), which adversely affects their growth and cognitive development. In-home iron~     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA~     by ensuring that the iron needs of infants and young children are met without changing their~     traditional diet. In order to optimize iron absorption timing of MNP consumption might as~     well be important. This is because hepcidin, a key regulator of systemic iron balance, shows~     a circadian increase that may influence morning versus afternoon iron absorption from the~     MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit~     iron absorption from a second dose, consumed close in time to the first dose.~      To determine the difference between i) morning versus afternoon iron absorption and ii)~     consecutive versus alternate day iron absorption, investigators will enrol 20 infants from~     Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2~     test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in~     the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals~     consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two~     consecutive days and 1 alternate day. In both studies, fourteen days after the last test~     meal administration, a whole blood sample will be collected by venipuncture for iron~     isotopic analysis. Iron and inflammation status parameter will be determined at baseline and~     endpoint. Hepcidin concentrations will be measured before the morning and afternoon meals~     (study 1) and after second consecutive meal (study 2).~      Knowing the effect of time on the expected iron absorption will inform decisions on the~     ideal timing of MNP to cover the infant's requirement for absorbed iron.~   "
5188|NCT02989298|"~     Brief Summary: The investigators are registering all PD patients at recruited hospitals and~     developing a PD database in China. Patients will be followed up every 3 months, and both~     baseline and follow-up information will be collected and input into the registration system.~     The patient survival, technical survival, peritonitis rate, longitudinal changes of residual~     renal function and peritoneum function, and quality of life for PD patients, etc, will be~     compared using the PD database.~   "
5209|NCT02989025|"~     The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to~     mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby~     outcomes.~   "
5189|NCT02989285|"~     Human Immunodeficiency Virus (HIV) remains in infected patients receiving highly active~     antiretroviral therapy (HAART) for many years. Stopping HAART usually leads to re-emergence~     of small reservoirs of latent (inactive) HIV that reside inside certain types of infected~     cells, that can replicate and cause a full HIV infection. Chronic HIV infection also leads~     to long-term immune activation which is associated with higher incidence of serious non-AIDS~     events including cardiovascular disease and cancers. Thus HIV+ patients must remain on HAART~     indefinitely or replication-competent latent HIV reservoirs must be eradicated.~      The central nervous system (CNS) is a sanctuary site for latent HIV. For example,~     HIV-associated neurocognitive disorders (HAND) develop and persist in about 40% of HIV+~     persons despite long-term HAART and viral suppression in blood and cerebrospinal fluid~     (CSF). Continued CSF immune activation is also frequently observed despite viral~     suppression. Both of these are likely to indicate ongoing low-level HIV replication in the~     CNS.~      Several strategies to eradicate latent HIV are being explored. One of these, known as shock~     and kill involves awakening latent HIV and inducing replication to make it more~     susceptible to host immune responses and HAART. However, there are several major caveats to~     its application in the CNS such as the risk of triggering a serious immunoinflammatory~     response (e.g., meningoencephalitis) that cannot be easily controlled by HAART. Other~     eradication strategies may also be problematic given that many latency-reversing agents have~     limited penetration of the blood brain barrier and limited efficacy in astrocyte cells. To~     improve the effectiveness of new eradication therapies it will be crucial to develop better~     methods to identify and quantify latent HIV reservoir sites with greater precision.~      To identify potential HIV latency biomarkers in the CNS, the investigators will study HIV+~     patients stable on HAART and virally-suppressed in blood and CSF over 24 months. Because~     such a marker should be associated with HAND or its development without changing~     significantly with HAND progression, half of the sample will have HAND at study entry and~     half will not. Patients will undergo neuropsychological testing and give blood and CSF~     samples every 6 months to identify candidate biomarkers and track them prospectively against~     HAND development and progression. MRI brain scan will also occur at study entry and after 24~     months.~   "
5190|NCT02989272|"~     It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis~     is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular~     junction,potentiate the duration of deep neuromuscular block following rocuronium~     curarization in patients undergoing general anesthesia. Magnesium sulphate has gained~     prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of~     neuromuscular blockade among other functions.~      The deep neuromuscular block is defined as the one obtained by the absence of response to~     the sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic~     counts . There is no literature description of the role of magnesium sulphate in Duration of~     the deep neuromuscular block obtained after the muscle relaxation of patients with~     rocuronium This study is justified because extending the clinical duration of neuromuscular~     blockers may translate into gains for surgeries that require deep and long-lasting muscle~     relaxation as in laparoscopic and robotic surgeries. This block allows lower inflation~     pressures of the pneumoperitoneum to be obtained, as a result, there is a lower inflammatory~     and cardiorespiratory repercussion for the patient~   "
5191|NCT02989259|"~     In this study, the investigators try to evaluate the efficacy and safety of apatinib in~     advanced non-squamous head and neck cancer and to validate the correlative biomarkers.~   "
5192|NCT02989246|"~     This pilot study tests the feasibility of using a computerized ventilator management~     protocol seeking to encourage lung protective ventilation during the acute phase of~     ventilation, and esophageal manometry based titration of ventilator settings during the~     weaning phase of ventilation, for children with acute respiratory failure. The investigators~     hypothesize that such an approach will reduce time on mechanical ventilation, largely by~     preserving diaphragm muscle function.~   "
5193|NCT02989233|"~     In the present study, 144 children (72 males and 72 females), whose ages ranged between~     8-13, were divided into 12 equal experimental groups according to their ages and gender.~     They were all considered to have poor hygiene. Only one out of the three different education~     methods (brochure, model or video) was applied to each group. The percentage change in PI,~     GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.~   "
5194|NCT02989220|"~     Some women experience the pain of miscarriage on numerous occasions. Studies show that these~     women experience feelings of anxiety and distress during the early stages of a new pregnancy~     as they worry another miscarriage will occur. This study will investigate whether a coping~     strategy, developed for a similar group of women, would be acceptable and useful to women~     suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A~     secondary aim of the study is to develop a deeper understanding of the experiences and~     feelings of women in the early stages of a new pregnancy, following multiple miscarriages.~   "
5195|NCT02989207|"~     The aim is to perform a randomised feasibility trial preceding a large prospective~     randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with~     Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black~     African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.~      The UK Office of National Statistics estimated that among the population of England in 2007,~     approximately 4.3% were of African/African-Caribbean background, while in large cities such~     as London and Birmingham about 20% of the population is of African/African-Caribbean origin.~     For eye units in these cities, managing glaucoma in this population is challenging and we~     need to identify a better alternative to our current standard surgical treatment.~      There is now evidence from one RCT which shows better overall outcomes from tube surgery in~     comparison to trabeculectomy for glaucoma. However, this study did not address black~     populations specifically and did not address the potential role of MMC in tube surgery.~      This feasibility study will enable us to design a fully powered RCT with the aim of~     determining how best to optimise the surgical treatment of POAG in black populations, by~     comparing outcomes in three types of glaucoma surgery.~   "
5196|NCT02989194|"~     This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the~     safety and tolerability of VIS410 in subjects with uncomplicated influenza.~   "
5197|NCT02989181|"~     The aim of this randomized controlled study is to investigate the effect of continues~     positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and~     concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function~     measured by magnetic resonance (improvement of at least 4%) after six months treatment with~     CPAP.~      The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality~     of life.~   "
5198|NCT02989168|"~     This is an open label study in which eligible IPF subjects who are using supplemental oxygen~     at rest will receive GBT440 orally daily.~   "
5199|NCT02989155|"~     The purpose of this study is to determine the need for a blood transfusion during surgery~     and to evaluate the levels of certain proteins in the blood when given tranexamic acid.~   "
5200|NCT02989142|"~     The project focuses on prevention of major pregnancy and birth related complications :~     pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section~     (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90%~     percentile of birth weights for the specific pregnancy duration.~      The investigators focus on the pre-conception period, i.e. the pre-conception period of the~     2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to~     decrease the complications rate in their 2nd pregnancy.~      Women with an excessive gestational weight gain have obtained the extra weight during a~     rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy.~     This characteristic distinguishes the target group from the general population with~     overweight/obesity, in whom the extra weight was acquired during many years and independent~     from a pregnancy, making a behaviour change more complex.~      The coaching intervention combines face-to-face counselling with the use of a mobile App~     connected to medical devices (scale and pedometer). The app monitors important indicators~     (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through~     established behavioral change techniques, and is specifically tailored for women with~     excessive weight gain during the previous pregnancy.~      The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next~     pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained~     during the next pregnancy.~   "
5201|NCT02989129|"~     The goal of this clinical research study is to learn about the effectiveness of quercetin in~     treating and preventing CINP. Researchers also want to learn if quercetin has an effect on~     participant's quality of life.~   "
5202|NCT02989116|"~     The purpose of this study is to determine whether a daily executive training to cognitive~     inhibition, working memory or mindfulness as compared to an active control condition has a~     near- and far-transfer impact on brain and behavioral measures as collected in children aged~     9-10 years, either born preterm or full-term.~   "
5203|NCT02989103|"~     Background:~      Hyperthyroidism is a common disease. It is very common for women. It is usually treated with~     Radioiodine (I-131). Some people think that this might cause cancer, even many years later.~     Past studies of people with hyperthyroidism have not been clear about cancer risks after~     I-131. Researchers want to look at a group of people with the disease who got I-131 many~     years ago. They want to look at how their health was months and years later.~      Objective:~      To learn more about disease risks in relation to radiation from I-131 treatment for~     hyperthyroidism.~      Eligibility:~      People who were part of the previous study. These are people who were diagnosed with~     hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants~     have already died.~      Design:~      Researchers will examine data already collected by the past study. This includes data on~     participants later cancers and other health outcomes after they had I-131 treatment.~      Researchers will compare that data to a National Death Index search.~      This was already done for data up through 2003. This study will cover 2004 2014.~      Researchers will not be in touch with study participants or their next of kin....~   "
5204|NCT02989090|"~     Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to~     efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an~     overall improvement in the quality of care for such patients. Despite the efficacy of remote~     monitoring of ICDs and the satisfaction of patients and providers with the process, there is~     a desire from patients to have access and view ability of the data their ICD is~     transmitting. However, methods for making ICD device data directly available to the patients~     are not currently in place. This study aims to elicit the impact of standardized remote~     monitoring ICD data to patients through an electronic personal health record (ePHR) on~     patient engagement, healthcare utilization, and patient-provider communication. For this~     study, patients with an ICD manufactured by St. Jude Medical and that are undergoing remote~     monitoring through the remote management system, Merlin.net™, will receive a standardized~     format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview~     Health. The standard format for the electronic remote monitoring ICD data, as it is~     delivered to the patient, will be termed the ICD Patient Notification Summary. Additionally,~     provider attitudes and perceptions regarding the value of the Patient Notification Summary,~     its impact on clinic workflow, and patient-provider communication will be collected.~   "
5205|NCT02989077|"~     This study will delineate the risk profile of patients with isolated cerebral or coronary~     ischemia and those with combined disease. The study will also evaluate current management~     status of those patients and any unmet needs.This aim is proposed to be achieved by studying~     3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to~     be 1000 patients.~   "
5206|NCT02989064|"~     This study will investigate the safety and tolerability of MAGE A10ᶜ⁷⁹⁶T cell therapy in~     subjects who have the appropriate HLA-A2 tissue marker and whose melanoma or bladder or head~     and neck tumor has the MAGE-A10 protein expressed. This study will take a subject's T cells~     and give them a T cell receptor protein that recognizes and attacks the tumors.~   "
5207|NCT02989051|"~     Rationale: Fluid overload is a common complication in children who are admitted to the~     pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent~     cause for admission to the PICU and forms an uniform group with a single organ failure. In~     these critically ill children, fluid overload is associated with adverse outcome.~     Restricting the volume of fluids already in an early stage of ICU admission may prevent~     fluid overload during mechanical ventilation and thus improve clinical outcome. However, at~     the same time fluid restriction may interfere with appropriate energy and macronutrient~     intake that is needed for recovery.~      Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive~     fluid management protocol and investigate its effect on the occurrence of fluid overload in~     mechanically ventilated children with acute infectious lung disease.~      Study design: Single-center prospective randomized feasibility and pilot study in~     preparation of a multi-center randomized controlled trial (RCT).~      Study population: Mechanically ventilated children with (suspicion of) acute infectious lung~     disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's~     Hospital, Academic Medical Center, Amsterdam.~      Intervention: Patients receive either liberal (control group) or a restrictive (experimental~     group) fluid treatment, while ensuring appropriate caloric intake.~      Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body~     weight during the first week of mechanical ventilation. Secondary outcomes (in preparation~     of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and~     oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to~     treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as~     energy and protein intake are studied.~      Both fluid management protocols reflect a variant of current clinical practice, hence will~     not provide extra burden or risk to patients included in the study. Patients will be~     randomized to either of the fluid protocol arms on admission to the PICU (at start of~     mechanical ventilation). Patients included in the restrictive fluid treatment arm might have~     direct benefit from the study if indeed fluid overload is less common in this group.~   "
25909|NCT02718014|"~     The present study was evaluated periodontal status in pre and post-menopausal women with~     periodontitis following non-surgical therapy.~   "
5211|NCT02988999|"~     Prospective, randomized, double-blind, controlled-trial 30 subjects in each groups Group - I~     consume pure D-allulose 5 g 3 times a day before meal to right after meal (with any liquid)~     and Group - II control group with non-calorie sweetener erythritol 5 g 3 times a day before~     meal to right after meal (with any liquid) Total number: n = 60 Either males or females,~     non-diabetic, aged > 18 years old with BMI ≥ 25 kg/m2~      Primary objectives Efficacy~      1. Compare the efficacy of pure D-allulose (psicose) plus conventional therapy on 1.1~     visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) change 1.2 body~     weight, BMI and body fat percentage (with impedance method) change after 24 weeks of~     D-allulose (psicose) consumption to erythritol consumption and between pre- and~     post-intervention.~      Secondary objectives 1. Efficacy of pure D-allulose (psicose) plus conventional therapy~     versus erythritol plus conventional therapy on 1.1 insulin resistance, fasting plasma~     glucose, HbA1c 1.2 adiponectin, leptin and tumor necrosis factor-alpha, lipid profiles~     (total cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein, LDL,~     chylomicron), apolipoprotein AI, apolipoprotein AII,apolipoprotein B48, apolipoprotein CIII~     and apolipoprotein E, free fatty acids 1.4 waist circumference, hip circumference, waist/hip~     ratio~      Safety~      1. Safety of the study by comparing with conventional therapy, monitoring blood pressure,~     pulse rate, hematological parameters and urinalysis~   "
5212|NCT02988986|"~     This is an open label phase II clinical trial to determine the efficacy, toxicity, and~     safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative~     breast cancer.~   "
5213|NCT02988973|"~     The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted~     from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in~     the treatment of anemia in non-dialysis chronic kidney disease patients. Another~     uncontrolled cohort will be included to evaluate the efficacy and safety of ASP1517 in~     patients converted from epoetin beta pegol (CERA). This study will also assess the~     safety/efficacy of long term treatment of ASP1517 (52 weeks).~   "
5214|NCT02988960|"~     This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and~     pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or~     recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as~     combination therapy with nivolumab in participants with advanced solid tumors.~   "
5215|NCT02988947|"~     The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience~     Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and~     prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee~     Arthroplasty~   "
5216|NCT02988934|"~     The purpose of this study is to create a registry (collect data and keep it in a research~     database) to learn more about two methods of taking small tissue samples from your esophagus~     (the esophagus is the tube that carries food and liquid from your mouth to your stomach.).~     The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples)~     from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.~      By recording the results of all of your biopsies over many years, it may be possible to find~     out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn~     develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and~     which patients with Barrett's esophagus develop precancer and cancer. The data from your~     biopsies will be used to determine the best way to diagnose esophageal disease.~      You are being asked to participate in the study because you are receiving an upper endoscopy~     (a procedure where a tube with a light and camera are inserted in your mouth and down your~     throat) with forceps and brush biopsies of your esophagus as part of your standard clinical~     care, and you are between the ages of 18 and 80.~   "
5217|NCT02988921|"~     Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging~     (DWI) are advancing imaging technologies that have potential to overcome limitations of~     conventional staging methods, radiation treatment planning and the assessment of tumor~     response in esophageal or esophagogastric cancer. This study aimed to explore the value of~     MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume~     delineation as compared to CT simulation for patients with unresectable or potentially~     resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT~     texture features are also extracted before and during treatment to establish a model to~     predict the prognosis of patients.~   "
5218|NCT02988908|"~     A comparison of memory training with and without donepezil.~   "
5219|NCT02986386|"~     Oral health is a critical factor of systemic health, although usually forgotten. A potential~     relation between cognitive deficits and oral diseases has been suggested. Adult cognitive~     dysfunctions have a high impact, not only economic, but social and in the family~     environment. Based on anatomical connectivity between the oral cavity and the central~     nervous system, the proposed study hypothesizes that masticatory function is a relevant~     determinant of human cognitive health. The restoration of canonical masticatory function and~     masticatory training could help to delay the development of such conditions. This project~     will also test if restoring phasic masticatory function improves the execution of cognitive~     tasks.~   "
5220|NCT02986373|"~     This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability~     of risankizumab in subjects with psoriatic arthritis (PsA) who have completed all doses of~     study drug and the Week 24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA~     subjects, sponsored by Boehringer Ingelheim).~   "
5247|NCT02988609|"~     This study assess the putative persistence of neural damage using resting state fMRI after~     concussion in rugby player once they have clinically recovered. The hypothesis is that~     despite a clinical recovery (absence of symptoms; neurological and neuropsychological~     examination returned to normal) connectivity map obtained using resting state fMRI are~     significantly different from a group of control subjects.~   "
5248|NCT02988596|"~     Approximately 420 professional and amateur athletes will participate in rehabilitation~     during recovery after sports-related concussion. Participants will be cluster randomized, by~     study site, to a specific study arm. Participants will complete post-injury assessments and~     the intervention of their randomized group aimed at understanding the effects of a~     multidimensional rehabilitation protocol versus enhanced graded exertion on clinical~     recovery, return to play, and patient outcomes after sport related concussion~   "
5221|NCT02986360|"~     1. To develop brief informational videos, Vidscrips, that can be sent to women following~          their mammogram to provide personalized information that integrates breast density with~          overall breast cancer risk, and provides information about additional care~          recommendations and talking tips for conversations with the health care providers.~        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.~          The investigators hypothesize that individuals in the intervention arm (vs. those in~          the standard care arm who receive a letter with the language required by the~          legislation) will have more accurate knowledge of their overall risk of breast cancer,~          their Mammographic Breast Density (MBD) result, more appropriate observed and intended~          use of additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI)~          will be reserved only for women at high risk of breast cancer], better satisfaction~          with their episode of breast cancer screening, less decisional conflict about their~          personal decision for any additional evaluation, and less worry about breast cancer.~   "
5222|NCT02986347|"~     The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In~     the last decade some studies have described the performance of this surgery using local~     anesthesia with adrenaline without the necessity of sedation or the use of pneumatic~     garrote, having good effectiveness and substantial reduction of costs. However there is need~     for studies with an appropriate design and methodology to evaluate the actual effectiveness~     of this kind of anesthesia for the surgical treatment of CTS.~      Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized~     trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local~     anesthesia with adrenaline without limb garroting (Lalondi).~      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of~     Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with~     co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This~     study will be a Randomized Clinical Trial. The previous calculation of the sample resulted~     in 77 patients. The following primary outcomes will be assessed: Pain through visual~     analogue scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be~     recorded. The secondary outcomes will be: Use of Analgesics, Anxiety and Depression through~     the HADS (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston~     Carpal Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical~     intervention, complications and failures.~   "
5223|NCT02986334|"~     This study is designed to examine brain properties for placebo response in chronic back pain~     patients. The investigators have preliminary data indicating that, in blinded clinical trial~     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can~     be subdivided into placebo responders and non-responders, and these differences are~     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have~     clinical utility and that its properties can be studied by human brain imaging techniques.~     In Phase I of the study, the investigators seek to identify brain imaging parameters that~     predict the propensity for the placebo response in an independent CBP cohort. In Phase II,~     the investigators will evaluate the interaction between placebo response and medication~     treatment in individuals stratified as placebo responders versus non-responders. This~     research is designed to critically assess the neurobiology of placebo analgesia for chronic~     pain in a partially-blind clinical trial.~   "
5224|NCT02986321|"~     The purpose of this study is to evaluate the dose-response relationship of different doses~     of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further~     development in the target patient population.~   "
5225|NCT02986308|"~     The aim of this study is to confirm the TCM syndrome types and TCM constitution~     classifications of the patients with intestinal polyps via on-site epidemiological survey,~     to analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers,~     and to study the metabolomics differences of the two populations and the metabolomics~     variations of the patients with intestinal polyps of pre-polypectomy and post-polypectomy.~     Finally, this study is to investigate the serum metabolomics variations of patients with~     intestinal polyps of pre-polypectomy and post-polypectomy and the relationship with their~     TCM syndrome types and TCM constitution classifications, to determine the correlation among~     pathology, TCM constitution, TCM syndrome types and the metabonomics variations of patients~     with intestinal polyps.~   "
5226|NCT02988882|"~     The purpose of this study is to evaluate the efficacy and safety of OTX-DP compared to~     Placebo Drug Delivery Vehicle (PV) for the treatment of the signs and symptoms of chronic~     allergic conjunctivitis.~   "
5227|NCT02988869|"~     The overall objective is to asses the bronchodilator effect of once daily~     Tiotropium/Formoterol combination delivered via Discair® compared to Tiotropium (q.d.)~     monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler +~     formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with~     stable moderate to severe COPD.~      Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different~     times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1~     hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min~     [10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].~   "
5228|NCT02988856|"~     Objective 1: Determine the safety and feasibility of externally mounted magnets for extended~     management of chronic eyelid movement disorders by measuring visual acuity and corneal and~     skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on~     the relative efficacy of external magnetic devices by comparing them to externally mounted~     lid weights and ptosis crutches using rating scales and video analysis of blink~     biomechanics.~   "
5229|NCT02988843|"~     This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab~     for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on~     imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein~     (AFP) or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits~     and determined by treating physician to be clinically significant. Patients unable to~     receive 2nd line of platinum-based chemotherapy due to toxicity or refusal would also be~     eligible.~   "
5230|NCT02988830|"~     The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain~     in chronic lumbago after 12 months of treatment.~   "
5231|NCT02988817|"~     The purpose of the trial is to establish the tolerability of HuMax-AXL-ADC in a mixed~     population of patients with specified solid tumors~   "
5233|NCT02988791|"~     Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:~     paroxysms of irritability, fussing, or crying that start and stop without obvious cause;~     episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least~     1 week; and no failure to thrive. The condition is very common in the first 4 months of life~     (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive~     and inconsolable crying without an identifiable cause. Infantile colic cause considerable~     stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all~     pediatric visits in the first 4 months of life) and frequent formula changes.~      The pathophysiology of IC is still poorly defined, but differences in gut microbiota~     composition seem to be involved. In particular, differences in the number and species of~     Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects~     with IC, and it has been postulated that these alterations could be responsible for an~     abnormal gas production within gut lumen resulting in distension and abdominal pain. These~     findings suggest the potential role of probiotics as preventive and therapeutic strategy for~     the IC.~   "
5234|NCT02988778|"~     This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral~     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients~     will receive Astrazeneca medication. There is no placebo group.~   "
5235|NCT02988765|"~     Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in~     which the preoperative evaluation is critical to address surgery between sentinel node~     biopsy or radical groin lymphadenectomy.~   "
5236|NCT02988752|"~     This study was a non-inferiority trial with masked data analysis. Individuals ranging from~     18 to 60 years from both genders that met the pre-defined criteria were included. This study~     was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de~     Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were~     performed for each eye of the individuals, under midriatic conditions. Evaluations were done~     by examiners who did not know previously results obtained from other equipment. Data was~     collected by the main researcher of this research. This study was approved by the ethics~     committee before it started and all research members signed the TCLE agreement. The~     statistical test employed in this study was Pearson Correlation test.~   "
5237|NCT02988739|"~     It is the aim of the present study to compare the immunogenicity induced by a laser-assisted~     epidermally administered seasonal influenza vaccine to an intradermally administered~     seasonal influenza vaccine.~   "
5238|NCT02988726|"~     RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma~     provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy~     suggest that it may prove beneficial in the treatment of adults with a recurrent/residual~     Neurofibroma or Schwannoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.~   "
5239|NCT02988713|"~     This is a prospective, multi-center, non-randomized, exploratory, single-arm study~     characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing~     a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~   "
5240|NCT02988700|"~     Caudal analgesia along with general anesthesia is a very popular regional technique for~     prolonged postoperative analgesia in different pediatric surgical procedures where the~     surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for~     approximately 4-6 hours.~      Recently, the use of spinal anesthesia in infants and children requiring surgeries of~     sub-umbilical region is gaining considerable popularity worldwide.~      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal~     anesthesia as an alternative to general anesthesia in infants and children undergoing~     surgeries of sub-umbilical regions.~   "
5241|NCT02988687|"~     This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period~     of six months and collect valuable pilot data to evaluate feasibility of a larger study and~     treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,~     fatigue, sleep quality, and QOL will also be collected. This exploratory study will also~     provide important information about recruitment and AGHD screening procedures in military~     settings.~   "
5242|NCT02988674|"~     The objective of this study is to access retention rate, persistence and adherence in~     population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis~     (PsA)) participants treated with adalimumab in routine clinical settings in the Russian~     Federation.~   "
5243|NCT02988661|"~     The purpose of this research is to examine whether the Chronic Disease Self-management~     Program (CDSMP) would improve health outcomes and reduce health care use in African American~     women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based~     self-management education program that has been shown to help people with chronic conditions~     to take control of their health problems. This study focuses on African American women with~     SLE because the CDSMP has not been widely studied in this population.~   "
5244|NCT02988648|"~     The purpose of this phase I/II study is to evaluate the safety and clinical activity of~     Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that~     overexpresses functional Na/I symporter. The study will enroll patients with metastatic~     breast cancer who have had clinical and/or radiographic evidence of disease progression on~     prior hormonal and/or chemotherapy.~   "
5245|NCT02988635|"~     This study compares two types of care - Standard Oncology Care (SOC) and SOC with early~     palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see~     which is better for improving the quality of life of patients with advanced lung, pancreas,~     gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure~     patients' quality of life.~   "
5246|NCT02988622|"~     The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to~     as Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional~     laser (referred to as CO2 Laser in this application) to determine if one is superior to the~     other in improving the appearance of scars over a series of three treatments. In addition,~     the investigators hope to identify a more cost-effective method to improve the appearance of~     scars caused by surgery or trauma.~   "
21052|NCT02781597|"~     The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding~     in patients of hemoptysis and also to evaluate the safety of tranexamic acid.~   "
5249|NCT02988583|"~     Silicone oil has been used as a surgical tool in complicated retinal detachment surgery.~     There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.~     Silicone oil emulsification is one of the complication that may result in severe sequels~     that are difficult to treat. It is believed that low viscosity silicone oil has more risk to~     develop emulsification than high viscosity silicone oil. Up to now, however, there is no~     conclusive guideline that which types of silicone oil is suitable for these complicated~     retinal detachment surgeries and what is the appropriate time to remove the oil. This~     prospective study aims to study the silicone oil emulsification comparing between low~     viscosity and high viscosity silicone oil after complicated retinal detachment surgery.~   "
5250|NCT02988570|"~     In recent years, several studies confirm that some of preterm children have language~     developmental disabilities, in production, in comprehension, or in written language. These~     language impairments lead to learning disabilities. There are, however, contradictions~     concerning the origin and nature of language dysfunctions. Some studies find lexical~     disorders (number of words used by the child), others preferentially phonological disorders~     (sounds used in the language), others also disorders of the morphosyntaxe (organization of~     the sentences) and fragilities that affect pragmatics (understanding situations).~      The computer-evaluation of the language is carried out at five and a half year coupled with~     the medical and neuropsychological examinations. The language assessment lasts 30 to 45~     minutes per child. It is carried out using a laptop computer that allows the submission of~     stimuli and recording of the child's responses. The language evaluation scale is the battery~     CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language~     evaluation. The assessment includes three tests: comprehension of words and phrases,~     production of words and phrases, and judgment of sentences. Each time, the child sees images~     and hears words or phrases. Sometimes he has to say what he sees on the computer screen.~      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years~     in the context of the follow-up of children born very preterm.~      The evaluation proposed to the child in this research will be carried out at a significant~     period of development, before writing. This assessment will not only assess the structure of~     the child's language, but also determine if there are possible difficulties in learning to~     read and write.~      The expected benefits for the health of the children included in the trial therefore concern~     the detection or characterization of any developmental fragilities affecting the language.~     These screenings or characterizations will make it possible to advocate a speech~     rehabilitation if necessary.~   "
5251|NCT02988557|"~     The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and~     dynamic electromyography recordings, will be studied in children with bilateral spastic~     cerebral palsy during level walking, and before and after a training on a treadmill with a~     sloped surface (7°). Data will be compared with those obtained in a sample of typically~     developing (TD) children (controls)~   "
5252|NCT02988544|"~     The aim of the study is to determine if collapsing an embryo (or making it fold compactly by~     taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in~     assisted reproductive technology (ART).~      Women coming to our ART center will be randomized in two groups : the collapsing group and a~     control group.~      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be~     determined in each group and correlated to pregnancy occurrence.~   "
5253|NCT02988531|"~     To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary~     artery disease.~   "
5254|NCT02988518|"~     Bipolar disorder is a major health concern. Intercritical periods are marked with residual~     symptoms, both thymic and cognitive, which affects quality of life of patients, but also the~     quality of observance. The implementation of cognitive remediation programs could be~     interesting. The aim of this study is to evaluate the overall performance on euthymic~     bipolar patients with memory complaints included in the program named COGMED, targeting~     the working memory.~      The impact of this program on compliance, quality of life, and memory complaints will be~     evaluated.~      The investigator will measure whether there is a correlation between working memory and~     overall performances.~      Finally, the investigator will try to achieve a profile of bipolar patients in whom the~     Cogmed program is particularly effective on a plan of overall performance.~   "
5255|NCT02988505|"~     Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical~     guidelines emphasize the role of compression therapy by prescription medical devices. Even~     in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may~     exist due to the price and reimbursement setting processes. OOPP may threaten the equity of~     care and drive patients to forgo care. Our aim was to analyze the distributive effects of~     OOPP for lymphedema patients in France.~      A prospective, multicenter study will be conducted in France in 2014 on patients with~     lymphedema. Household ability to pay will be specified by net income and OOPP will be~     assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,~     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory~     and voluntary health insurance reimbursements will be considered. We will combine~     concentration curves and concentration indices to assess the distributive effects.~   "
5256|NCT02988492|"~     The newest generation of stent--‐retrievers results in higher recanalization rates and~     faster recanalization time compared to older generation endovascular therapies for acute~     stroke. Advanced neuroimaging can potentially improve the assessment of infarct core and~     inform decision--‐making in patients being considered for endovascular therapy. Evaluation~     of infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation~     of CTP in predicting core infarct in acute stroke has been limited because recanalization~     status was lacking. In addition, final infarct size may be underestimated on NECT compared~     with MRI. These two limitations can now be addressed: the new generation of~     stent--‐retrievers allows accurate determination recanalization time; evaluating the test~     characteristics of CTP using 24 hour DWI--‐MRI as the reference standard can be readily~     performed.~      We aim to prospectively investigate the sensitivity and specificity of whole--‐brain CTP in~     predicting 24 hour DWI--‐MRI infarct in patients with acute proximal anterior circulation~     occlusions successfully recanalized with endovascular treatment.~   "
5272|NCT02988284|"~     Three hundred healthy individuals will be participants of the study. Participants will~     evaluate with the following assessment tools: Demographic datas; age, gender, height, body~     mass, will be recorded. Gait parameters (step length, variation of step length) will~     evaluate with Gait trainer Biodex 2, at participant's preferred speed.~   "
5287|NCT02988089|"~     Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been~     recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac~     gastric cancer. Strongly evidence supports that H. pylori eradication is an effective~     approach to reduce the incidence of those pathologies.~   "
5288|NCT02986295|"~     Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with~     Xience® stent~   "
5257|NCT02988479|"~     Primary lymphedema is a chronic condition posing a high burden on patients. Clinical~     guidelines emphasize the role of compression therapy by prescription medical devices. Even~     in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may~     exist due to the price and reimbursement setting processes. OOPP may threaten the equity of~     care and drive patients to forgo care. The investigators aim was to analyze the distributive~     effects of OOPP for primary lymphedema patients in France.~      A prospective, multicenter study will be conducted in France in 2015 on patients with~     primary lymphedema. Household ability to pay will be specified by net income and OOPP will~     be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,~     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory~     and voluntary health insurance reimbursements will be considered. The investigators will~     combine concentration curves and concentration indices to assess the distributive effects.~   "
5258|NCT02988466|"~     This is a single institution phase II study of a reduced intensity conditioning (RIC)~     followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with~     diagnosis of hematologic malignancy. Conditioning will consists of fludarabine,~     cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a~     melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index~     (CI) >3. This study uses a two-stage phase II design with accrual goal of 44 patients, using~     22 patients separately for arms A and B.~   "
5259|NCT02988453|"~     A single blind, randomized controlled trial to investigate the efficacy of a newly~     manualized psychotherapy Mentalization-Based Training for Adolescents with Conduct Disorder~     (MBT-CD) in comparison with Treatment As Usual (TAU).~   "
5260|NCT02988440|"~     A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of~     PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in~     first line. There will be a dose escalation part and a dose expansion part.~   "
5261|NCT02988427|"~     We will develop a new measure of patient engagement/activation specific to the context of~     diabetes self-care~   "
5262|NCT02988414|"~     Prospective study at Duke University Hospital comparing the Karius Infectious Disease~     Diagnostic Sequencing Assay to blood culture results in admitted patients with~     bacteremia/septicemia.~   "
5263|NCT02988401|"~     This study will evaluate if giving insulin that is administered in the nostrils (intranasal)~     is safe and tolerable for people with multiple sclerosis (MS). It is also being done to~     evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate~     how it might be working.~   "
5264|NCT02988388|"~     The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung~     tissues from donors and preparing and distributing collections of tissue specimens to~     researchers within and outside the LTRC. Collections of specimens will be linked to~     individual clinical data appropriate to the particular disease. The primary goal of the LTRC~     is to identify participants with suspected lung cancer or metastatic disease who are willing~     to provide informed consent for research use of their specimens and data. Secondarily, the~     LTRC investigators intend to collect clinical data, limited exposure data, physiologic~     studies, and radiographic studies from these participants.~   "
5265|NCT02988375|"~     The primary objective of the proposed research is to determine the efficacy of Digital~     Cognitive Behavior Therapy (dCBTI) in preventing the incidence of depression among~     insomniacs. In addition, we will identify salient sociological/environmental variables, such~     as socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care~     responsibilities (i.e., having children under the age of 3), stigma, that moderate the~     effects of this intervention.~   "
5266|NCT02988362|"~     The purpose of this study is to compare the safety and pharmacokinetics of HL068~     (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in~     healthy male volunteers.~   "
5267|NCT02988349|"~     caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited.~     Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate®~     Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks.~     Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before~     and after the treatment for laboratory analyses.~   "
5268|NCT02988336|"~     The purpose of this study is to assess the usefulness of the Thyromental Height Test in~     prediction of difficult intubation using double lumen endotracheal tubes in patients~     scheduled for elective thoracic procedures.~   "
5269|NCT02988323|"~     Sport concussions are among the most commonly occurring injuries in sport and recreation and~     pose significant public health implications for Canadians. Many individuals who sustain a~     concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may~     suffer from persistent symptoms. Little research is currently available evaluating the~     effects of treatment for individuals who are slower to recover following sport-related~     concussion. An initial RCT identified a significant treatment effect in individuals with~     persistent symptoms of dizziness, neck pain and/or headaches following sport-related~     concussion when treated with a combination of cervical and vestibular physiotherapy compared~     to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level~     aerobic exercise in combination with sport specific training may also be of benefit to~     facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016).~     Further evaluation of these treatments is required to better understand the effects of each~     treatment in isolation and in combination. This trial will have the ability to inform future~     multifaceted clinical trials as well as clinical practice. Ultimately, identification of~     optimal treatment paradigms will lead to a decrease in persistent symptoms and functional~     alterations in children and youth from this commonly occurring injury.~   "
5270|NCT02988310|"~     Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15~     healthy individuals will be participants of the study. Participants with lower limb loss~     will evaluate with the following assessment tools: Demographic datas; age, gender, height,~     body mass will be recorded. Gait parameters (step length, variation of step length, time on~     each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's~     preferred speed.~   "
5271|NCT02988297|"~     The purpose of this study is to determine whether nebulized RNS60 is effective in the~     treatment of amyotrophic lateral sclerosis (ALS).~   "
5273|NCT02988271|"~     Meditation is an approach that focuses on the connection between mind and body that uses~     techniques with breath, sound, or movement. It has been the focus of research because of its~     possible benefit for lowering distress and improving health and quality of life. The~     meditation techniques in this study are already used in clinical practice. They are based on~     the Tibetan tradition and focus on use of sound and breathing techniques.~      The goal of this research study is to learn how self-administered meditation (meditation~     participant completes on their own) can improve participant's mood-related symptoms, such as~     depression and anxiety. Researchers also want to learn how to deliver pre-recorded~     meditations using a computer-based application (program, or app).~   "
5274|NCT02988258|"~     The study will test the hypothesis that CMV TCR-transduced T cells, at a specific T-cell~     dose/kg, can generate a functional CMV immune response post-transplant, where CMV-specific~     donor T cells cannot be isolated by conventional means. This will be tested in the context~     of adult HLA-matched sibling allogeneic HSCT.~      In the proposed trial, an HLA-A*0201-restricted CMV pp65-specific T cell receptor (TCR) will~     be introduced into donor T cells via ex vivo GMP retroviral transduction. Donor T cells will~     be isolated from peripheral blood following a simple venesection procedure. The CMV~     TCR-transduced T cells will be tested for TCR expression, CMV-specific cytokine secretion~     and microbiological contamination before being frozen and stored at -80C. CMV seropositive~     transplant recipients will be tested weekly for CMV reactivation by quantitative PCR on~     peripheral blood. On first detection of CMV DNA > 200 copies/ml, 104 (cohort 1) or 105~     (cohort 2) bulk CMV TCR-transduced T cells/kg recipient weight will be infused into the~     patient.~      Blood will be taken regularly to determine persistence and expansion of the CMV~     TCR-transduced T cells. Weekly CMV PCR will be continued. Patients will be examined at~     appropriate intervals (daily if inpatients, twice weekly in BMT clinic if outpatients) for~     the development of graft versus host disease (GVHD) or other potential side effects.~   "
5275|NCT02988245|"~     Hypertension is one of the most important preventable contributors to disease and death in~     the United States and represents the most common condition seen in the primary care setting.~     Approximately 78 million adults living in the U.S. have hypertension with more than 5~     million new diagnoses made each year. Unfortunately, despite a significant impulse in the~     medical community to move towards an individualized medicine approach to patient centered~     treatment, the current clinical treatment strategy is based on a set algorithm which does~     not take into account individual patient differences. As a result hypertension is often~     sub-optimally treated based on population averages, rather than a person's genetic~     make-up, with significant burden on our health care system. In fact, 40% of patients who are~     adherent to their blood pressure therapy (taking their medicines as prescribed by their~     clinician) do not have their blood pressure under control. Previous work has demonstrated~     significant functional polymorphisms within the kidney, vessels, and heart that will likely~     predict a patient's response to blood pressure pharmacotherapy. Previous work by our group,~     utilizing a retrospective design, has determined that the addition of genetic knowledge to~     prescribing can improve therapeutic guidance and decrease the time to blood pressure control~     significantly. Despite this, to date, there are no prospective trials to guide blood~     pressure therapy using multiple organ systems that are important in the three most common~     classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical~     trial is to determine the efficacy of genetically guided therapeutic options for~     pharmacologic treatment of essential hypertension in newly diagnosed patients.~   "
5276|NCT02988232|"~     The Purpose of this trial is to investigate the efficacy and safety of~     Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain~   "
5277|NCT02988219|"~     This study evaluates the incidence of cardiac arrhythmias during the perioperative period in~     patients undergoing open kidney cancer surgery in the lateral position. All the participants~     will be randomly allocated to receive general (Group G) or combined epidural/general~     anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will~     be applied at the evening before the surgery, tracing continuously for a period of 24 hours~     (7PM-7PM)~   "
5278|NCT02988206|"~     In this study，researchers will use personalized objects to assess patients' level of~     consciousness in chronic patients in minimally conscious state (MCS).~   "
5279|NCT02988193|"~     The purpose of the PRECISION study is to compare a clinical reasoning artificial~     intelligence for hypertension treatment management with usual care (UC) and enhanced care~     (EC) in patients with poorly controlled hypertension.~   "
5280|NCT02988180|"~     Children in extreme poverty lack adequate care and face increased health risks. The earlier~     poverty strikes in the developmental process, the more deleterious and long-lasting its~     effects. There is, however, growing evidence that early interventions can prevent the~     negative consequences. Such interventions are effective, particularly when they are of high~     quality, organized at home and parents are involved. Recently, baseline assessment of~     developmental and nutritional status of SOS children and children in extreme poverty in~     Jimma region of South-West Ethiopia revealed that these children have developmental problems~     in language, motor, social-emotional skills and nutritional status. The impact of~     play-oriented stimulation activities integrated into the existing SOS basic program, on~     developmental outcomes, has never been investigated in this context. The main objective of~     the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into~     the basic SOS program on the developmental outcomes of children living with foster families.~     This was done by comparing the intervention children with their age-matched children~     (control), not receiving the stimulation package. It was hypothesized that this package~     would significantly improve the developmental skills of these children.~   "
5281|NCT02988167|"~     Knowing when to liberate critically ill patients from mechanical ventilation (i.e.~     extubation) is of great importance as both prolonged ventilation and failed extubation are~     associated with increased morbidity, mortality & costs. The study objective is to improve~     the safety of extubation by harnessing hidden information contained in the patterns of~     variation of heart and respiratory rate measured over intervals-in-time.~   "
5282|NCT02988154|"~     This study aims to investigate the efficacy of simulation in neurosurgical training.~   "
5283|NCT02988141|"~     A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese~     Patients with Advanced EGFRm+ NSCLC~   "
5284|NCT02988128|"~     Post market surveillance registry~   "
5289|NCT02986282|"~     Consecutive patients with atrial fibrillation will be admitted to the hospital for~     electrical cardioversion. Ankle brachial index will be measured three times with~     oscillometric method and three times with doppler method. Two study sessions will be~     performed: the first before and the second after electrical cardioversion. The first session~     will be ended before anesthesia. The second session will be started before a conscious~     patient will be transported from intensive care unit to general ward.~      All the measurements will be taken in the intensive care unit at an ambient temperature of~     21° C, after patients will give their written informed consent to participate in the study.~     All patients will be awake, fasting and in the supine position. ABI will be measured~     according to the guidelines issued by AHA. Systolic blood pressure will be measured using a~     Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid~     sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric~     method will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau,~     Switzerland). The appropriate cuff size will be used with the width of the cuff being at~     least 40% of the limb circumference. The arm with higher systolic blood pressure will be~     used to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial~     or dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI~     measurements will be repeated 3 times with each method in the reverse order of the preceding~     measurement e.g., in the case of the initial counterclockwise sequence: right arm, right~     popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm,~     the clockwise sequence will be used, starting and ending with the left arm. The same~     sequence of limb pressure measurements will be used used during the study.~      A sample size calculation was based on the preliminary observations made by the study team.~     It was calculated that the study sample size of 79 subjects would be needed to detect a~     difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a~     two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size~     of 115 patients incorporated an assumption of dropout due to non-effective electrical~     cardioversion, patient decision to quit study or failure to obtain adequate ABI.~      The measurements will be repeated three times with each method and for the each method the~     mean will be used for the calculations. Investigator - study nurse, trained at the vascular~     department, will perform all ABI measurements.~   "
5290|NCT02986269|"~     General anesthesia has been demonstrated to have a negative impact on lung function. Both~     surgery and patient position influence the perioperative lung function. Laryngeal mask~     airway (LMA) has been proved to be safe and efficient to maintain the airways patent during~     general anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in~     clinical practice. The aim of the present trial is to characterize perioperative changes in~     lung volume, ventilation inhomogeneity and respiratory mechanics in patients in the~     lithotomy position and spontaneously breathing through LMA with and without PSV.~   "
5291|NCT02986256|"~     The TELEPIED project aims to show that it is possible to reduce the number of~     hospitalization days of a patient with ulcers of the foot thanks to a new organization of~     care, based on the intervention of a coordinating nurse interacting with the nurse in charge~     of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring~     itself a regular follow-up of the evolution of the wound and adapting the support nurse to~     the home if necessary.~      It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of~     the foot.~      Patients included in the conventional group will be followed according to the usual practice~     Patients included in the telepied group will benefit from a personalized accompaniment by~     a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by~     acting by delegating tasks of the investigator.~      The patient will be visited by the referring nurse every 15 days. During these visits, the~     referring nurse will have the objective to evaluate the evolution of the ulcer as well as~     the care performed. This visit also allows a close personalized accompaniment for the~     patient, who will benefit from an education adapted to the characteristics of ulcer~     (discharge modalities for example ..) and its way of life.~      Every patients will be followed for one year (12 months).~   "
5292|NCT02986243|"~     The purpose of this study is to determine if an assigned physical fitness program will~     result in weight loss to prepare patients for kidney transplant.~   "
5293|NCT02986230|"~     The objective of this project is to implement and evaluate the effectiveness of a~     sophisticated Web-based, electronic health record (EHR)-linked clinical decision support~     (CDS) system designed to improve primary and secondary cancer preventive care.~      This project will engage a rural population with substantial healthcare disparities and gaps~     in the receipt of primary and secondary cancer prevention. Results will advance~     dissemination and implementation research methods that can reduce health disparities and~     improve healthcare for millions in medically under-served areas.~   "
5294|NCT02986217|"~     This study seeks to establish the effect of regular structured feedback on surgical~     performance using crowd sourced video assessments with validated objective performance~     scores and time to complete a specific surgical procedure through a randomized controlled~     trial. The working hypothesis is that regular structured assessment will lead to a greater~     measurable improvement in performance, as defined by objective performance scores, than will~     traditional feedback methods.~   "
5295|NCT02986204|"~     This study will investigate in-office ultrasound localization vs localization in radiology~     for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and~     aims to help establish best practices in this domain. Investigators will also create an~     ultrasound image gallery of palpable and non palpable as well as instructional video for non~     palpable ENG implant removal.~   "
5296|NCT02986191|"~     Twenty patients with gingival recession will be enrolled in this trial. Gingival recession~     will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while~     on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.~      Patients will be followed for 3 and 6 months by measuring the clinical indexes and~     statistical analyses will be performed to compare the results and to assess the success of~     Mucograft®.~   "
5297|NCT02986178|"~     This is a randomized phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) alone~     or in combination with the chemotherapy drug lomustine in adult patients with recurrent~     World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain~     Tumor Center (PRTBTC) at Duke.~   "
5298|NCT02986165|"~     This study evaluates the acute and longer term effects of a tomato pomace extract on~     platelet aggregation in health subjects.~   "
5299|NCT02986152|"~     The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic~     stress disorder (PTSD) in cancer patients and caregivers. Based largely on PTSD Coach from~     the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms~     and is tailored specifically to individuals impacted by cancer.~      This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a~     randomized controlled trial (RCT) where subjects are placed into either the intervention~     group or the wait-listed control group for a period of 8 weeks. The CDC app is available as~     a free download on the App Store® and on Google Play™.~   "
5300|NCT02986139|"~     Assess the injection site pain associated with a New Etanercept formulation in adult~     subjects with RA or PsA~   "
5301|NCT02986126|"~     Depressive symptoms and disorders are among the most common adult health conditions with a~     lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide.~     Although evidence-based approaches such as cognitive behavioral therapy (CBT),~     antidepressant medications, and depression collaborative care and quality improvement (QI)~     programs integrating depression care into primary health care can improve depression~     outcomes and disparities, racial / ethnic disparities continue to persist. Concurrently,~     according to a 2011 Institute of Medicine (IOM) report, little information exists on how to~     address the high rates of depression among sexual and gender minorities.~      Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial~     / ethnic minority adults to an evidence-based agency-level, depression quality improvement~     (QI) training [Resources for Services (RS)] and technical support alone or to a resiliency~     class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood +~     automated mobile text reminders about basic reminders and care follow-up impact on improving~     adult patients' depressive symptoms. Depression QI (RS) training will be offered to three~     clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA)~     and one cluster in NO. Clusters are comprised of one primary care, one mental health, and~     two to three community agencies (e.g., faith-based, social services/support, advocacy). All~     programs will receive depression QI training. Enrolled adult depressed patients (n=320) will~     be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary~     outcomes: depressive symptoms [8-item patient health questionnaire (PHQ-8) score and~     secondary outcomes: mental health quality of life [12-item mental composite score (MCS-12) ≤~     40], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of~     life [12-item physical composite (PCS-12)score] at 6- and 12-month follow-up.~   "
5302|NCT02986113|"~     This study will determine if suicidal middle-aged men who use a personalized computer~     program addressing suicide risk before a primary care visit are more likely to discuss~     suicide and accept treatment, reducing their suicide preparatory behaviors and thoughts.This~     is important because half of all men who die by suicide visit primary care within a month of~     death, yet few broach the topic, missing chances for prevention.~   "
5303|NCT02986100|"~     The purpose of this study is to characterize the mass balance, absorption, metabolism, and~     elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle~     treatment with rucaparib continuing until disease progression or other reason for~     discontinuation~   "
5304|NCT02986087|"~     Tracheal occlusion IDE approved by FDA for severe congenital diaphragmatic hernia fetuses.~   "
5305|NCT02988063|"~     This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression~     therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in~     adults with severe venous disease of the great saphenous vein (GSV). All participants will~     receive treatment with Varithena and compression therapy.~      The purpose of this study is to assess whether the use of PEM to correct superficial axial~     and varicose vein reflux is effective in improving healing of VLUs, over treatment with~     compression alone.~   "
5306|NCT02988050|"~     Sixty patients were randomly allocated into two groups, group PD and group PR, thirty~     patients in each group. Patients in PD group received propofol and dexmedetomidine~     intravenous infusion and patients in PR group received propofol and remifentanil intravenous~     infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean~     arterial blood pressure, oxygen saturation, and side effects such as respiratory depression,~     nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.~   "
5307|NCT02988037|"~     The investigators conducted a pre-post naturalistic study regarding changes observed~     associated with a 15-week course of an adapted form of dialectical behaviour therapy for~     adolescents. We measured frequency of self-harm prior to treatment and after treatment using~     the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the~     Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and~     Adolescents.~   "
5308|NCT02988024|"~     The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005~     oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under~     fasting conditions in healthy subjects between 18 and 50 years of age.~   "
5309|NCT02988011|"~     In this explorative randomized clinical study, the investigators aim to study metabolic,~     cellular, and molecular changes that occur during weight loss in obese subjects with and~     without type 2 diabetes. Using novel imiomics (imaging technique using PET/MR~     bioinformatics) analyses to examine possible metabolic differences between energy restricted~     diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity,~     glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat~     content, and gene expression in adipose tissue. This study aims to identify novel biomarkers~     and drug targets for type 2 diabetes as well as validate promising and established~     biomarkers in an interventional model for improved glucose metabolism.~   "
5310|NCT02987998|"~     The purpose of this study is to determine the feasibility and evaluate the safety of~     delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in~     combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after~     surgical resection. Consolidation therapy is treatment given following the initial~     treatment.~      Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved~     by the FDA for use in certain types of skin cancer (melanoma), and for use in certain types~     of head and neck cancer. However, it has not been approved for use in other cancers such as~     non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the~     surface of some cells of the immune system and activates them against cancer cells. It is~     not chemotherapy.~   "
5311|NCT02987985|"~     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)~     technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce~     postoperative respiratory depression in the post-anesthesia care unit and ward in children~     with sleep-disordered breathing undergoing tonsillectomy when compared with traditional~     opioid-containing techniques. It is expected that this OFA regimen will have a measurable~     reduction on postoperative respiratory depression in children with sleep-disordered~     breathing.~   "
5312|NCT02987972|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of two~     different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The~     primary hypothesis of the study is that the proportion of participants receiving V114 who~     have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,~     6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for~     recipients of Prevnar 13™.~   "
5349|NCT02987491|"~     Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic~     exercise can increase insulin sensitivity in the few hours following exercise, however the~     cellular mechanisms are not completely understood. The current project is to investigate~     mechanisms of exercise improvements to skeletal muscle insulin sensitivity.~   "
5313|NCT02987959|"~     This is an open-label phase II study of TAK-228 for patients ≥ 18 years of age with complex~     genomic sarcomas exhibiting Phosphoinositide-3 Kinase (PI3K) pathway dysregulation. Patients~     must have surgically unresectable or metastatic disease that is refractory to at least one~     prior line of therapy (not including neoadjuvant or adjuvant therapy in a curative setting).~     Patients disease must also have evidence of progression prior to enrollment. The purpose of~     this study is to determine the antitumor activity in this group of patients. Patients must~     meet all eligibility criteria as detailed in section 10. A total of up to 33 patients will~     be included in the study. Patients will undergo screening evaluations to determine~     eligibility within 28 days of the first dose. All patients will be required to submit~     baseline tumor samples for analysis. Patients who have had their tumors tested commercially~     for PI3K/ AKT/mechanistic Target of Rapamycin (mTOR) alterations will be assessed on a case~     by case basis for eligibility and for determination as to whether additional tissue is~     required.~      TAK-228 will be administered orally at 3 mg daily for a 21 day cycle. Clinical and~     laboratory assessments will be made on day 1 of each cycle. Disease will be assessed by~     comparing unidimensional tumor measurements on pre and peritreatment imaging (CT or MRI)~     after weeks 6, 12, 18 and every 12 weeks thereafter. Response will be assessed according to~     RECIST 1.1. Therapy will continue until disease progression or unacceptable toxicity or~     withdrawal of consent.~   "
5314|NCT02987946|"~     In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to~     the relatively long duration of surgery, the high occurrence of prolonged immobilization of~     patients due to paresis of the legs or intracranial pathology causing inability to~     mobilise2. Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause~     hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in~     attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity,~     insufficient power of performed studies and lack of careful phenotyping and description of~     risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the~     optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with~     adequate power and detailed information on patient related factors (malignancy, subarachnoid~     haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and~     postoperative immobilisation will allow us to identify the optimal treatment strategy for~     high risk neurosurgical patients.~      In the current study all patients that fulfil the inclusion criteria will be subjected to~     post-operative systematic evaluation of VTE by echo-duplex investigation.~   "
5315|NCT02987933|"~     Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy~     normals and may be sufficiently different to allow a high level of classification accuracy~     of whether subjects have chronic pain. In addition, investigators will utilize DTI and a~     brief activation state using pain rumination to assess whether investigators can reliably~     find differences between chronic pain sufferers and healthy normals.~   "
5316|NCT02987920|"~     Total knee arthroplasty (TKA) is one of the most painful orthopedic procedures. After TKA~     surgery, postoperative pain relief may be achieved using a variety of techniques. Integral~     to recovery and improved outcomes is early ambulation and mobilization. Achieving adequate~     postoperative pain control while ensuring the ability to ambulate early can be quite~     challenging.~      Currently, in our country there has been a call to address prescription opioid use and abuse~     due to a nationwide opioid epidemic. In light of this, improving our multimodal analgesic~     protocol will serve to decrease reliance of opioid medications for pain control. Multimodal~     analgesia is effective in decreasing total opioid consumption postoperatively.~     Dextromethorphan is a low-affinity noncompetitive N-methyl-D-aspartate (NMDA) receptor~     antagonist. It has a long history of clinical use with an established safety record. Studies~     have shown that it has a positive effect as an analgesic.~      In order to see if dextromethorphan will decrease opioid use, this study will look at two~     patient groups undergoing total knee arthroplasty with the same preoperative,~     intraoperative, and postoperative anesthetic plan with the exception of the addition of~     dextromethorphan to one groups multimodal analgesic regimen. This study is designed as a~     double-blinded, randomized, prospective cohort trial.~   "
5317|NCT02987907|"~     The current random, double-blind, controlled, clinical trial was designed to evaluate the~     impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar~     carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.~   "
5318|NCT02987894|"~     The purpose of this post-market registry is to collect and monitor ongoing safety and~     performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™~     Transferral Delivery System, when used as per IFU.~   "
5319|NCT02987881|"~     This study will evaluate whether the use of the Jawbone wristband monitor, in connection~     with home-based exercise and nutritional counseling can be safely completed and improve~     cardiorespiratory fitness (heart and lung health) in women with early stage endometrial~     cancer who have undergone surgery.~   "
5320|NCT02987868|"~     In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH)~     increased 682% above baseline 120 minutes after oral administration of an amino acid-based~     dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH~     stimulation by ghrelin, we hypothesize that the supplement suppresses somatostatin, a know~     inhibitor of both hGH and TSH. To test this hypothesis, we measured triiodothyronine (T3)~     after administration of the amino acid-base supplement.~   "
5321|NCT02987855|"~     Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and~     Fibromyalgia represent progressive systemic pain conditions which often worsen over time.~     They appear to be dysregulation of the central nervous system (CNS) and the autonomic system~     (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and~     disabilities. They are often associated with injury sites (including surgical) which produce~     constant, often disabling pain and motor-sensory losses.~      Treatments are often ineffective and include medications (often high dose opiates), Physical~     Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators~     of the CNS.~      Study is an interventional study to document the safety and efficacy of use of~     adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction~     disease groups.~   "
6842|NCT02967887|"~     This study is to assess the efficacy and the safety of hepatic arterial infusion of~     cisplatin and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker~     expression predicting therapeutic response.~   "
5322|NCT02987842|"~     This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate~     the posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment~     (MCI) and early Alzheimer's disease (AD).~      EEG-NFB has been successfully used as a clinical tool for over 40 years. It is based on~     electrical activity measured near the surface of the brain using EEG and fed back to the~     patient within half a second.~      MCI is a clinical condition considered as a precursor of AD. NFB appears to be a promising~     approach to treat MCI, since it has been shown to be able to induce changes in brain~     plasticity. This research focuses on the PCC, which has been reported to be implicated in~     MCI, and due to its location (proximity to the surface) accessible by means of EEG- NFB.~      A preliminary research in MCI patients, conducted at our lab showed the lower the memory~     score was at the beginning of the training, the better a subject managed to improve later~     on. The investigators therefore presume that patients with early Alzheimer's disease, whose~     cognitive ability is more affected compared to MCI, may benefit from EEG-NFB as well, and~     maybe to a larger extent compared to MCI.~   "
5323|NCT02987829|"~     This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in~     which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will~     receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose~     escalation) and part 2 (dose expansion).~   "
5324|NCT02987816|"~     Recent changes in medical training environments and restrictive work-hour regulations have~     greatly impacted trainees, limiting the number of opportunities to gain proficiency in~     procedural skills. Reports suggest that medical residents lack confidence in their ability~     to perform certain medical procedures, and program directors often do not believe their~     residents can operate independently in major procedures. Simulator based task training~     (SBTT) has provided a safe and ethically appropriate method of skill acquisition but~     training opportunities remain limited. Methods to enhance motor learning during these~     training opportunities have not been described. Transcranial direct-current stimulation~     (tDCS) is an emerging form of non-invasive brain stimulation that has been shown to improve~     motor learning. tDCS has been shown to enhance increasingly complex skill acquisition. The~     investigators propose to examine if tDCS can improve the acquisition and retention of~     neurosurgical skill. The investigators propose a double blind, sham-controlled randomized~     trial applying tDCS during evidence-based SBTT of medical students, to determine if brain~     stimulation can enhance training skill acquisition and retention. Even a modest enhancement~     carries the potential to transform medicosurgical skills training.~   "
5325|NCT02987803|"~     The investigators aim to conduct a randomized controlled trial of women who are pregnant or~     considering pregnancy to understand whether women provided with specific data on~     hospital-level cesarean delivery rates are more likely to select higher quality hospitals,~     defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020~     target of 23.9%.~   "
5326|NCT02987790|"~     The judicious use of antibiotics is one of the main measures to limit the emergence of~     multidrug-resistant pathogen related to excessive antimicrobial use. A recent study~     demonstrated that C-reactive protein (CRP) was as useful as procalcitonin (PCT) in reducing~     the time of antibiotic therapy in adult septic patients treated in the ICU setting.~     Therefore, the present study proposes to compare the time of use of antimicrobials, costs of~     hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided~     by serum levels of CRP and a group of therapy based on the best practices of antibiotic~     therapy (Best Practice).~   "
5327|NCT02987777|"~     The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs~     and to investigate its correlation impact with progression-free survival (PFS), and~     clinicopathological features including microsatellite instability and quantified stromal and~     intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)~   "
5328|NCT02987764|"~     Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP)~     with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has~     life-long neurological consequences that affect quality of life for the patient. In the last~     2 decades, improvements in neonatal intensive care have improved survival of VLBW infants~     significantly. This increased survival of VLBW infants poses new challenges towards~     developing novel treatments and interventions to decrease neurodevelopmental impairment and~     CP. While it is common for extremely preterm infant to survive at 23 weeks of gestation, the~     neurologic consequences range from learning difficulties and cognitive defects to severe~     disability and cerebral palsy. Currently prenatal neuroprotective agents such as~     corticosteroids are utilized whenever a preterm birth is anticipated. However, there are no~     proven postnatal interventions to prevent brain damage and cerebral palsy in VLBW infants.~      Many recent studies show that delaying umbilical cord clamping (DCC) may improve hemodynamic~     stability and decrease intraventricular hemorrhage (IVH) in preterm infants. A decrease in~     incidence of IVH has a conceivable prospective benefit of decreasing brain injury and~     improving long-term outcomes. Based on these findings, the American College of Obstetricians~     and Gynecologist and American Academy of Pediatrics endorse that DCC may benefit the preterm~     infants. However, these recommendations have not been adopted by most obstetricians in USA.~     The main concern regarding the practice of DCC is the care delay in initiating resuscitation~     and providing the needed care to this vulnerable population.~      Therefore, as an alternative to DCC, method of cord milking (CM) has been developed to~     provide cord blood transfusion to premature infants. CM offers a more practical alternative~     to delayed cord clamping that may provide the same benefits without the need to delay~     resuscitation. However, there are very few studies of CM in VLBW infants and there is no~     evidence demonstrating long-term neurological outcomes and CP after CM.~      The investigators hypothesize that cord milking in VLBW infants will result in improving~     cerebral oxygenation, function and result in improved long-term neurodevelopmental outcomes~     at 2 years of post-menstrual age. Premature infants born at less than or equal to 32 weeks~     gestation age will receive cord milking after cutting versus standard care of immediate cord~     clamping.~   "
5329|NCT02987751|"~     This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal~     Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2~     Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The~     primary outcome measures will be to compare the change in HbA1c from baseline to week 24~     between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin~     naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms~     between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point~     self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%,~     Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,~     BMI and Blood pressure.~   "
5350|NCT02987478|"~     All patients will undergo in vitro fertilization.~      Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.~      Whole blood specimens will be collected in serum separator tubes using acceptable medical~     techniques to avoid hemolysis.~      Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.~      clinical pregnancy will be confirmed by observation of intrauterine sac visible on~     ultrasound performed 4-5 weeks after embryo transfer.~   "
5330|NCT02987738|"~     Dapagliflozin has a unique mechanism of action that does not directly affect either insulin~     resistance or insulin secretion, but rather improves glycemia by reduction of glucose~     re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily~     glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic~     control with reduced variability may also lead to reduced frequency of hypoglycemia.~      In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve~     target glucose irrespective of preexisting HbA1c levels.~      In this pilot study data will be collected to investigate the effect on glucose of two doses~     of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed~     automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an~     in-patient setting combined with an automated sensor based CE marked insulin delivery system~     to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring~     of subject safety and assessment of the effects of dapagliflozin in a structured setting.~      If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and~     leads to an increase of time within the target glucose range when using a sensor based~     insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.~   "
5331|NCT02987725|"~     The purpose of this study is to test the effects of a laboratory-based hypnosis session on~     peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents~     (ages 12-18) with sickle cell disease and healthy controls, and examine how perceived~     disease-related stigma may affect these responses.~   "
5332|NCT02987712|"~     Recently it has been acknowledged that cirrhotic patients present with rebalanced~     hemostasis that results from decreased levels of both pro-coagulant and anti-coagulant~     factors, that is not well reflected by conventional coagulation tests (CCTs).~     Thromboelastography (TEG) might be a more accurate tool in these patients.~      Numerous guidelines on the management of the cirrhotic patient undergoing invasive~     procedures have been published but most of them are not evidence based. Current literature,~     although conflicting, is leaning towards a restrictive approach to prophylactic correction~     of coagulopathy when performing invasive procedures in cirrhotic patients. The investigators~     suspect that common practice is more liberal . Considering the well-known adverse effects of~     blood product administration, the aim of the study is to re-evaluate the clinical management~     of cirrhotic patients undergoing invasive procedures.~      Study objectives: asserting whether the use of blood products prior to invasive procedures~     in cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in~     place of CCTs, evaluating the rate of complications due to blood product use, and checking~     how well CCT results correlate with TEG results in these patients.~      This will be a prospective pre/post TEG protocol implementation study which will include two~     prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior~     to minor invasive procedures will be based on CCTs and physicians' clinical judgement.~     Survey 2: management will be based on a new TEG protocol. The investigators will include~     cirrhotic patients with coagulopathy who are candidates for an invasive procedure. Subject~     will be provided with sufficient time to reach a rational, informed decision regarding~     participation in the study.~      Data will be collected from the computer based medical record systems, the patient file and~     directly from the caring physician and will include a thorough medical history and~     conventional blood tests, including a TEG test. All subjects will be managed according to~     standard of care.~      Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused~     in preparation for the invasive procedures.~      Secondary endpoints: bleeding complications, transfusion related side effects, 90 day~     survival and other complications.~      This will be a prospective (pre/post) study. The calculated sample size needed is 120~     subjects, 60 in each group.~   "
5333|NCT02987699|"~     The purpose of this phase II study is to determine the recommended dose, as well as the~     safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by~     hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular~     carcinoma (HCC).~   "
5334|NCT02987686|"~     Corneal melt is a complication that could affect very ill eyes and lead to the thinning of~     the cornea (the clear window covering of the eyes). This thinning can lead to severe~     consequences such as the leakage of the liquid inside the eye (ocular perforation), or even~     blindness. Corneal melt can be caused by certain infections or as a sterile process. This~     project only includes patients with a sterile corneal melt (without an infection) caused by~     diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens~     Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.~      Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or~     prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this~     situation, infliximab was used intravenous (using veins) in order to treat the whole body.~      This study's hypothesis is that infliximab can safely be used as eye drops for the treatment~     of sterile corneal melt.~   "
5335|NCT02987673|"~     Background While several articles have reported about the effects of laparoscopic sleeve~     gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has~     discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is~     expected to be the first randomized trial exploring and comparing these two interventions.~      Setting Federico II University Hospital, Naples - ITALY.~      Methods Fifty morbid obese patients are going to be studied. All patients presenting with a~     normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts)~     or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and~     esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and~     24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or~     MGB/OAGB.~      Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2~     patients determining a possible increase in gastroesophageal acid or non acid reflux?~     Endpoint 2: Does one between the two procedures outperform the other one in terms of~     eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or~     MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to~     weight loss?~   "
5336|NCT02987660|"~     The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis~     (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for~     the treatment of myopia with astigmatism.~   "
5337|NCT02987647|"~     To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and~     Antrofi cream in improving vaginal moisture in postmenopausal women who are currently~     registered options most current and available in the market in order to assess the~     differences between them, subsequently conduct a clinical study larger.~   "
5338|NCT02987634|"~     Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of~     Sambucus nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival~     inflammation in an experimental gingivitis model in a phase II study, as well as in numerous~     other clinical trials. The product and its individual components were shown to be safe.~      Based on these favorable results, Izun is now seeking to demonstrate that a combined~     anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and~     reduce localized inflammation following dental implant surgery equal to, or better than, a~     chlorhexidine rinse, with fewer side effects.~   "
5339|NCT02987621|"~     In this project the investigators will be using non-invasive brain stimulation on people~     with multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants~     will be recruited. One group will perform strength testing with and without the brain~     stimulation. After completing the strength testing the participants will walk for six~     minutes to see if any increases in strength translate into improve mobility. The second~     group of participants will perform a fatigue task, pulling against a wire at a low level of~     force, with and without the brain stimulation. This type of brain stimulation has been shown~     to transiently improve strength and fatigue measures in other populations, e.g. aged,~     Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is the~     investigator's hope that the increases in performance seen in other patient groups will also~     occur in people with multiple sclerosis. Future investigations will look to apply the~     non-invasive brain stimulation technique during physical rehabilitation to improve short and~     long term outcomes related to physical function.~   "
5340|NCT02987608|"~     There is an increasing demand for digital tools to empower young people with mental health~     difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are~     increasingly being used to support child mental health. Evidence suggests that young people~     want to be active participants in their care and involved in decisions about their~     treatment. However, there is a lack of digital shared decision making tools available to~     support young people in Child and Adolescent Mental Health Services (CAMHS). This study aims~     to develop Power Up, a smartphone app to empower young people in CAMHS to make their voice~     heard and to participate more in decisions around their care.~      The project will involve two phases:~        -  Development Phase -Developing Power Up according to the views and ideas expressed by~          young people, their parents/ carers, and clinicians in Patient and Public Involvement~          (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS,~          10 parents/ carers and 10 clinicians to review the acceptability of the content and~          format of Power Up.~        -  Feasibility testing Phase -Conducting a feasibility trial with 120 young people with~          emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will~          receive treatment as usual and 60 will use Power Up alongside treatment as usual.~          Participant's ratings of empowerment, activation, and symptoms will be measured soon~          after their referral to the service. The same measures plus shared decision making~          questionnaires will be administered three months later.~      The findings will inform the planning of a prospective cluster controlled trial. More~     broadly this trial will contribute an understanding of the feasibility and acceptability of~     developing and implementing a shared decision making app into CAMHS.~   "
5341|NCT02987595|"~     Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular~     disease and certain cancers. Studies have shown that diets with high whole-grain content~     could decrease the risk of these lifestyle related diseases and in Sweden the national~     dietary guidelines recommends whole-grain based instead of refined cereal products. It is,~     however, not clear whether whole-grain from wheat and rye share similar protective effects~     since there are large differences in amount and quality of dietary fibre and associated~     bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet~     with low- or high lignan content on different cardiometabolic risk factors with the primary~     endpoint being blood glucose levels after 2h oral glucose tolerance test in men with~     metabolic syndrome or sign thereof.~   "
5342|NCT02987582|"~     Living with symptoms of mental illness is associated with psychosocial impairment as it can~     affect someone's ability to work, their relationships and level of functioning. This also~     has high economic costs on a societal level. It has been shown that an increase in~     self-compassion may result in a secondary benefit of reducing psychological distress, which~     could offer substantial benefits. There is little empirical data on Emotion Focused~     Mindfulness (EFM) interventions for the population we are studying. This study aims to~     address this gap in the literature and practice, thus advancing the field.~   "
5343|NCT02987569|"~     12 month study testing mobile delivery of health information and connections to~     professionals and peers to improve health of teen/young adult HPN users.~   "
5344|NCT02987556|"~     The study will be conducted in crossover trial, with two 12-weeks periods separated by a~     Wash-out period of at least one month. According to randomization ,patients will be provided~     with either Diabeloop system or the usual system.~      Patients will be trained for the use of blood glucose meter, of external Insulin Pump and~     Diabeloop system.~      In both treatment periods, the same blood glucose meter will be used throughout the duration~     of the study.~      In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be~     performed during four weeks to improve the efficacy of Diabeloop system with data~     collection, to test the manual settings by health care providers and patients and to check~     the good-working of the follow-up platform.~   "
5345|NCT02987543|"~     The purpose of this study is to evaluate the efficacy and safety of olaparib versus~     enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant~     prostate cancer who have failed prior treatment with a new hormonal agent and have~     homologous recombination repair gene mutations.~   "
5346|NCT02987530|"~     The purpose of this study is to compare the impact of two combination of two tablets once~     daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat~     associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in~     patients with primary HIV-1 infection.~   "
5347|NCT02987517|"~     This study will use a comparative effectiveness design of two interventions known to reduce~     running impacts. The study will be conducted at the Spaulding National Running Center. A~     total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per~     week will be recruited from the local running community. All potential subjects will be~     cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and~     screened via high-speed video to determine their habitual footstrike pattern. Those who are~     rearfoot strikers will be included and will then be randomized to either an increased~     cadence (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will~     be provided to both groups for the duration of the study. All participants will attend 2~     strength-training instruction sessions with a physical therapist prior to gait-retraining~     intervention. They will be instructed to perform the learned exercises daily for 4 weeks to~     prepare the body tissues for forces associated with new gait methods. Subjects will then~     attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two~     sequential days of training followed by a day of rest. The gait retraining protocols will be~     conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3~     points following intervention (1 week, 1 month, and 6 months).~   "
5348|NCT02987504|"~     This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)~     samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,~     PK/pharmacodynamic parameters, and efficacy in patients with advanced solid tumors.~   "
5351|NCT02987465|"~     In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is~     often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO~     is safe to use but it has been associated with a rise in blood pressure (BP) in some~     individuals. The reasons for this are not clear. To try to explain this, this study will~     look at how EPO affects certain substances in the blood that influence how blood vessels~     contract and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123~     and Noradrenaline into the arm vessels of volunteers using an established method called~     Forearm blood flow (plethysmography). Volunteers recruited for this study will include CKD~     patients undergoing therapy with Darbepoetin as part of their normal NHS care as well as~     healthy people not on treatment, who will act as controls. This is an observational pilot~     study of changes in physiology before and after Darbepoetin. It will provide valuable data~     for a later study comparing Darbepoetin to novel agents which work via different pathways to~     treat anaemia.~   "
5352|NCT02987452|"~     Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure~     (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic~     parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive~     (RHTN) patients, have not been investigated yet.~   "
5353|NCT02987439|"~     Purpose: In a randomized controlled trial we will assess the effect of early pulmonary~     rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease~     (AECOPD).~   "
5354|NCT02987426|"~     Mindfulness-based interventions have gained increasing popularity in recent years as~     effective treatment for mental illness. Mindfulness is defined as paying attention in a~     particular way: on purpose, in the present moment, and non-judgmentally: Being, rather~     than Doing. Such mental states can improve emotional regulation through frontal cortex~     inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal~     mindfulness approaches such as mindfulness-based cognitive therapy (MBCT) and~     mindfulness-based stress reduction, have been highly effective in a broad range of~     psychiatric disorders.~      Mindfulness-oriented interventions, are potentially useful in acute psychiatric~     hospitalizations, since they can be delivered as group therapies and are be both~     cost-effective and scalable. However, such interventions have rarely been provided to~     patients during psychiatric hospitalizations, where patients are treated for a variety of~     psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had~     been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent~     meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients~     with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly,~     MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar~     disorder, severe anxiety, substance use disorders, and major depressive disorder.~      Few studies have examined mindfulness-oriented treatments in inpatient settings, including~     two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10)~     8,19. Another study (n=23) offered inpatients with a diagnosis of major depressive disorder~     mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in~     inpatient settings were feasible, although these needed to be brief interventions, given the~     risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental~     illness.~      A cross-sectional study conducted by our team (n=40) demonstrated that brief group~     mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric~     inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no~     symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported~     improvements in general well-being and mood after a single 10-minute session. Having been~     recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75%~     of inpatients) did not affect patients' capacity to tolerate and benefit from the~     intervention. In this inpatient psychiatric population, we found that mindfulness-oriented~     interventions that were brief and involved physical movement (e.g. seated Tai Chi) were~     better enjoyed compared to other interventions.~      Despite the growing literature in this field, data is needed on the effectiveness and health~     service implications of brief group mindfulness-oriented interventions in inpatient~     psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to~     methodological flaws, including inadequate control groups, very small sample sizes (often~     n<10), and lack of randomization 6. In Canada, the direct cost of treatment for mental~     illness is estimated as 42.3 billion$. Much of these costs are driven by psychiatric~     admissions. Thus, if brief mindfulness-oriented interventions are effective at lowering~     psychiatric symptom severity and shortening psychiatric hospitalizations, this could lead to~     significant cost-savings.~   "
5355|NCT02987413|"~     Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that~     selectively affects motor neurons in the brain and spinal cord, leading to bulbar,~     respiratory, and limb weakness. There is no effective treatment, and the disease usually~     progresses to death within 2 to 4 years. The therapeutic plasticity of mesenchymal stem~     cells (MSCs) may be an attractive therapy to this complex disease, turning MSCs strong~     candidates for cellular therapy in ALS.~      Design—A phase 1 open-safety clinical trial. 4 patients will be selected according to a~     restricted inclusion and exclusion criteria and after 2 escalated infusions of MSCs, there~     will be a follow up period of one year Methods - Primary endpoint: safety of mesenchymal~     autologous stem cells infusions escalated in two intrathecal administrations in patients~     with ALS defined as severe adverse events (SAe). Secondary endpoints: clinical response,~     laboratorial and magnetic resonance imaging of patients submitted to cellular escalating~     doses applied in the study. Quality of life, according to El Escorial criteria, ALSFR scale~     and functional scales.~      Conclusion: This study is a primary step before a large randomized double-blind clinical~     trial for ALS. It is expected to confirm the safety of escalated MSCs therapy in ALS~     patients, initial data of efficacy in addition to improved quality of life.~   "
5356|NCT02987400|"~     The purpose of this study is to evaluate the clinical activity and tolerability of a~     combination of obinutuzumab plus venetoclax in patients with relapsed or refractory diffuse~     large B-cell lymphoma.~   "
5357|NCT02987387|"~     This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT~     Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular~     outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market~     setting.~   "
5358|NCT02987374|"~     The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in~     healthy young adults by vaccinating participants and obtaining blood samples at designated~     time points before and after vaccination.~   "
5359|NCT02987361|"~     The investigators hypothesize that transcranial direct current stimulation (tDCS) can~     improve upper limb motor recovery in the sub-acute phase of stroke patients.~      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.~   "
5360|NCT02987348|"~     This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD)~     database analysis to compare therapy effectiveness, and cost between exenatide and basal~     insulin in patients with type 2 diabetes.~      Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels~     (hyperglycaemia) that can result in an increased risk of a variety of conditions including~     heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients~     may control their blood sugar by lifestyle modification (diet and exercise), ultimately most~     will require therapeutic intervention with regimens that increase in complexity as T2DM~     progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to~     weight loss as well as improved blood glucose control. It has also been associated with~     reduced heart attacks and strokes. In this study CPRD database will be used to compare~     outcomes for patients prescribed exenatide compared with those prescribed insulin; a more~     established treatment for T2DM. In particular changes from baseline in blood sugar control~     and weight will be considered as the primary outcomes. As the choice to treat with exenatide~     or insulin will be related to patient characteristics which may in themselves be associated~     with the outcomes of the study we aim to match study patients on some of these key variables~     and adjust for others in our analysis.~   "
5361|NCT02987335|"~     India has the world's highest prevalence of diabetes, expected to rise to 80 million by~     2030. This includes many patients with lean diabetes, with low body mass index (BMI) and~     severe complications of diabetes. Despite its prevalence in India and other countries and~     its dire health consequences to individuals with the disease, little is known about the~     aetiopathogenesis and the genotype-phenotype relationship, lean diabetes being a cluster of~     low birth weight individuals, MODY, lipododystrophic disease, type 1 diabetes and~     fibrocalcific disease. While rudimentary tests have suggested defects in both insulin~     secretion and action, no comprehensive metabolic studies have been performed. It is~     therefore unclear as to how these patients should be treated. The optimal therapeutic~     adjunct whether a suitable oralantidiabetic agent or insulin is not yet determined. Defining~     the metabolic defects of 'lean' diabetes should have tremendous therapeutic benefit for~     millions of patients with this elusive condition.~   "
5374|NCT02986035|"~     This pilot trail aims to assess the effectiveness of ECA cream in the treatment of~     calcifying shoulder tendinitis in terms of:~        1. Reduction or removal of shoulder calcifications~        2. Functional improvements~        3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post~          intervention onset. The intervention will consist in the application of the ECA cream~          in the affected shoulder twice a day during 1 month.~   "
5362|NCT02987322|"~     Background: Honey, as a natural product produced by honey bees, has anti-oxidant,~     anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that~     honey might have positive effects on cardiovascular diseases.~      Methods: This was a randomized controlled study, which was carried out on 50 children, aged~     2 to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were~     randomly assigned into two equal groups: the honey group and the control group. In the honey~     group, honey was provided in a dose of 1.2g/kg/day for three months in addition to the~     traditional treatment of IDC. The patients in the control group received only their standard~     treatment, without honey. The main outcome measure was the percent change in the ejection~     fraction (EF) and the fraction shortening (FS) shown in echocardiography.~   "
5363|NCT02987309|"~     Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical~     status. There is however poor correlation between these calculations and actual energy~     consumption measured with indirect calorimetry (IC). Available equipment for IC has however~     been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated~     in modern ventilators. This functionality is easy to use, but we do not know if the results~     are reliable for children. This study is a method comparison study comparing measurements~     done with SensorMedics Vmax (gold standard) vs GE Carescape (modern ventilator with~     Integrated IC) in children undergoing intensive care treatment.~   "
5364|NCT02987296|"~     The immune system plays an important role in helping to kill and prevent cancers. Cells of~     the immune system, such as natural killer (NK) cells and T cells, do not work as well~     following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the~     body. Surgery has shown to cause a reduction of arginine in the body. In turn, this~     deficiency causes NK cell suppression. In this study, we want to look at the effects of~     arginine supplementation before and after surgery on NK cell function in surgery patients.~     In this study, we will be using a nutritional supplement containing arginine and a placebo~     drink (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer~     patients 5 days before surgery and 5 days after surgery. Using patient blood samples, we~     will measure NK cell levels, arginine levels and also arginase activity.~   "
5365|NCT02987283|"~     The investigators will perform a diagnostic accuracy study comparing tracheal breath sound~     recordings in awake individuals to the STOP-Bang screening questionnaire, using the~     apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.~   "
5366|NCT02987270|"~     This study is a cluster-randomized controlled trial to evaluate the efficacy of~     community-based mass screening with a malaria rapid diagnostic test, and treatment of~     participants with positive tests with an appropriate antimalarial for reducing malaria~     transmission indices.~   "
5367|NCT02987257|"~     Defining the true effect of adjunctive therapy for Stevens-Johnson Syndrome and Toxic~     Epidermal Necrolysis (SJS/TEN) on time to full healing, mortality, and long-term outcomes~     represents a critical need in the field of dermatology and burn surgery. Collaborating with~     20 sites from across North America we will determine if cyclosporine or etanercept therapy~     improves SJS/TEN short outcomes above supportive care alone The scientific premise for this~     study is that case series, cohorts, and small non-randomized studies have not supported the~     use of non-pulsed corticosteroids and intravenous immunoglobulin (IVIG), while showing the~     promise of cyclosporine and etanercept in reducing the time to complete~     re-epithelialization. By indirect comparison, etanercept appears to be superior in small~     studies, however none of the studies have evaluated these therapies in a blinded and~     randomized trial. Additionally, we will uncover the underlying process of SJS/TEN through~     the analysis of skin samples, blood, blister fluid and immune cells to study the immune~     system and changes in gene expression with and without drug therapy. This will improve the~     treatment of patients in the future.~   "
5368|NCT02987244|"~     The purpose of this study is to determine determine the maximum tolerated dose (MTD) and~     safety of the combination of Chidamide combined with CHOEP(cyclophosphamide，~     epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in~     newly-diagnosed T-NHL.~   "
5369|NCT02987231|"~     The objective of this study is to evaluate clinically and through the concentration of~     inflammatory markers, the results of 6 months of electrical stimulation associated with~     coronally advanced flap for treatment of gingival recession.~   "
5370|NCT02987218|"~     Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial~     aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate.~     Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards~     early surgery offers challenge to anesthesiologist to provide optimum brain relaxation and~     simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to~     conduct smooth neurosurgical procedure. These agents may affect patient's cognitive function~     postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic~     agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane).~     Provision of neuroprotection with propofol and volatile inhalational agents has been studied~     by various authors.Not many studies have been performed in patients undergoing aneurysmal~     clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O)~     brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol~     and desflurane for long term postoperative cognitive decline in patients undergoing surgery~     following aneurysmal subarachnoid hemorrhage.~   "
5371|NCT02986074|"~     The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant~     based on anatomical landmarks with standard surgical implantation technique.~   "
5372|NCT02986061|"~     The aim of this study was to investigate whether urinary catheterization could be avoided~     for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia~     plus multi-site infiltration analgesia.~   "
5373|NCT02986048|"~     The purpose of this study is to establish a database (or registry) of patients treated~     with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping~     track of the patients treated it will allow the investigators to periodically evaluate the~     outcomes of patients.~   "
5386|NCT02987166|"~     This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT)~     administered in combination with pembrolizumab in patients with solid tumors.~   "
25910|NCT02718001|"~     Early feasibility study to evaluate the safety and function of the Edwards Lifesciences~     CardiAQ™ Transcatheter Mitral Valve~   "
5375|NCT02986022|"~     Background:~      Resilience is important for successful adaptation. The investigators' resilience~     intervention was effective in enhancing resilience, emotional functioning, and adaptation in~     Mainland immigrants. In the present proposal, the investigators will work with the~     International Social Service to scale up application of this intervention in immigrants, and~     develop the training infrastructure to ensure that the evidence-based intervention can be~     sustained despite turnover of interventionists.~      Objectives:~        1. To deliver the resilience intervention to 200 new immigrants,~        2. To enhance their resilience by 5%, and decrease their depressive symptoms by 20% and~          adaptation difficulties by 10% after the completion of the intervention, and~        3. To establish a sustaining mechanism which ensures that this intervention can continue~          to be used in routine services.~      Project design:~      Well-trained social workers will deliver the intervention. Participants will complete~     programme evaluation. A train-the-trainer workshop and training materials will be prepared~     to transfer knowledge to social workers who are future trainers.~   "
5376|NCT02986009|"~     The collaborator has its vision as To have children, individuals, families and migrants~     across countries live in dignity and harmony, and be contributing members to a just, humane~     and caring society. Parents are very significant in the families as they need nurturing,~     discipline, teaching, monitoring, and managing their children as well as their families.~     Capable and competent parents bring good child outcome and happy family. The investigators~     planned to serve targeted parents in two areas as 1. Emotion management and 2. Information~     on community resource. In the first set, the participants are expected to improve their~     emotion management leading to a more effective parenting. In the second set, the~     participants would acquire more information that enables them to better use the community~     resources.~      To work closely with the collaborator, and based on the previous results of an effective~     parenting intervention, the investigators will modify the intervention to tailor the needs~     of targeted parents. The objectives are:~        1. After completing the parenting intervention, 150 participants will, 1.1. To increase~          participants' emotion management strategies by 20%, 1.2. To enhance positive affect by~          10%, 1.3. To decrease negative affect by 10%, 1.4. To enhance satisfaction with the~          parent-child relationship by 10%, 1.5. To increase subjective happiness by 8%, 1.6. To~          enhance family harmony by 5%, These levels of positive effects of the program were~          projected from the investigators' published findings.~        2. After joining the information sessions about education, health care, housing,~          employment, and community facilities, another 150 participants will, 2.1 To know more~          information of Hong Kong by 50%, 2.2 To know more information of Mainland China by 50%,~          2.3 To use more community resources either in Hong Kong or Mainland China by 50%.~      To study the effectiveness of parenting intervention, the investigators proposed to use a~     randomized controlled trial (RCT) that is a type of scientific study to reduce bias.~     Participants in this project will be randomly allocated to either the emotional management~     group or the information group. As the information group has no focus on parenting,~     participants would show no significant improvement in emotion management strategies or~     satisfaction with the parent-child relationship, etc. Meanwhile, participants in the~     parenting intervention would show no significant improvement in knowledge about either Hong~     Kong or Mainland China.~   "
5377|NCT02985996|"~     The purpose of this study is to determine the ability of new anti-HIV agents to penetrate~     different body compartments in HIV negative men who have sex with men and transgender women.~     These new agents might be considered for pre-exposure prophylaxis regimens in the future.~     This study will include 90 healthy, HIV-negative men who have sex with men and transgender~     women who are not taking hormones aged 18-49 years. Participant must be willing to~     participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and~     willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.~   "
5378|NCT02985983|"~     To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and~     non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as~     measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis~     international Society (ASAS) 40 response at week 16.~   "
5379|NCT02985970|"~     Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However~     several steps of RSI are not based on evidence based data (EBM) and are considered~     controversial. In an electronic evaluation form that will be send to Czech society of~     anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4~     clinical scenarios in which RSI should be used. In the questionnaire the participants have~     to choose RSI or no and they have to describe all the next steps on anesthesia induction~     process in each single clinical scenario.~   "
5380|NCT02985957|"~     The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary~     evidence of safety and effectiveness in treatment of metastatic castration-resistant~     prostate cancer~   "
5381|NCT02985944|"~     Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy~     withdrawal time >6min has been suggested to increase the ADR since it allows for thorough~     evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy~     system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle~     view. In the present study the authors evaluate the impact of WT on ADR for High Definition~     Standard Endoscopes with just a single imager to the FUSE endoscope.~   "
5382|NCT02985931|"~     The investigators aim to address this issue with novel image quantification methods using~     CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the~     quantification of the coronary flow. The investigators will use kinetic modeling techniques~     to design a study that allows the absolute flow quantification. To make this study~     practical, the investigators will develop a protocol that includes the acquisition of both~     the rest and stress scan within the same scan that is shorter than 30 minutes. The~     SPECT-measured flow will be validated against the flow measured with cardiac MRI scans.~     Patients with high CAD risk will be recruited for the clinical trial. Data from these human~     subjects will be used for determination of the performance of the developed algorithm. With~     the proposed rapid scan with absolute quantification capabilities, the investigators expect~     to increase the diagnosis accuracy while maintaining the patient throughput.~   "
5383|NCT02985918|"~     The main purpose of the present study is to verify whether, as compared with~     conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive~     positive pressure ventilation may more effective in correcting hypercapnia, hence reducing~     the need for intubation and improving survival in patients with acute exacerbation of~     chronic obstructive pulmonary disease.~   "
5384|NCT02987192|"~     Spinal canal anesthesia is marked the most commonly used method of cesarean section.~     Traditional spinal anesthesia may cause post-dural puncture headache and low back~     pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to~     accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose~     minimally invasive spinal anesthesia.~   "
5385|NCT02987179|"~     The clinical diagnosis of sleep apnea is difficult among ESRD patients since the~     characteristic clinical features of sleep apnea may be absent and since sleep-related~     symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the~     evaluation of patients with possible sleep apnea is the same among ESRD patients as in the~     general population.~   "
5387|NCT02987153|"~     Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with~     a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or~     potentially unstable spinal cord metastases. The primary objective is to evaluate the~     response rate of pain control when combining kyphoplasty, a minimally invasive procedure,~     with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord~     metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential~     unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within~     90 days post-procedure; (iii.) to determine which clinical factors are prognostic of~     vertebral compression fracture~   "
5388|NCT02987140|"~     The overall goals of this proposed study are to investigate the behavioral and~     neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing~     freezing of gait (FoG). More specifically, we aim to determine the behavioral changes in~     context-dependency and changes in corticomotor excitability associated with FoG.~   "
5389|NCT02987127|"~     Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with~     Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP~     eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of~     extragastric MALToma remains unclear. In addition to anecdotal case reports showing~     histologic regression of extragastric MALTomas after antibiotics, our explorative study~     found that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete~     remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular~     adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to~     Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings~     suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of~     these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21~     HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may~     also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the~     indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the~     treatment of early-stage low-grade extragastric MALToma.~   "
5390|NCT02987114|"~     Open-label,clinical study to evaluate the safety, tolerability and efficacy of oral~     administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy.~      Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow~     up.~   "
5391|NCT02987101|"~     Chronic leg ulcers are associated with decreased quality of life and an increased mortality.~     In many cases these ulcers are treated conservatively and the healing time can be several~     months. In this open randomized clinical trial we will examine if we can accelerate wound~     healing when using autologous stromal vascular fraction as an adjunct to standard wound~     care.~   "
5392|NCT02987088|"~     The purpose of this study is to determine the optimal dose of sodium nitrate administered~     during resuscitation to achieve a plasma level of 10 μM by hospital arrival.~      Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV~     dose of sodium nitrite will achieve the optimal (based on preclinical studies)~     neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100~     patients, we will determine whether 25 mg IV administered during resuscitation will achieve~     plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either~     decreasing or increasing, will be made if necessary permitting us to determine the optimal~     nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected~   "
5393|NCT02987075|"~     A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo~     transfer at 66±2 hours after ICSI using single step culture medium~   "
5394|NCT02987062|"~     According to current guidelines for non-valvular atrial fibrillation treatment, the first~     line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K~     antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval~     trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on~     real-life clinical practice.~      The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs)~     in an academic and district hospital, with regard to inclusion/exclusion criteria used in~     the clinical trials.~   "
5395|NCT02987049|"~     The purpose of this study is to fill in the gaps in knowledge on the tolerability and~     effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR)~     program on traditional cardiovascular risk factors, exercise performance, and patient~     well-being (as assessed by questionnaires), as well as to monitor subsequent clinical~     events. The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR) group~     will have greater improvements in several cardiovascular disease risk factors than patients~     in the conventional Cardiac Rehabilitation (CR) group at the end of 24 sessions.~   "
5396|NCT02987036|"~     The purpose of this study is to find out weather differences in administration nebulizer~     technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables~     (Compliance, resistance and PEEPi) during controlled mechanical ventilation.~   "
5397|NCT02987023|"~     The study is a follow up of NCT01844362. Uterus transplantation will be performed from live~     donors to patients with uterine factor infertility. If will be performed before~     transplantation. Organ procurement from the donor will be performed by robotic assisted~     laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12~     months after transplantation. After birth of 1-3 children the uterus will be removed by~     hysterectomy,~   "
5398|NCT02987010|"~     Cohort A - neoadjuvant administration of IDH305 at 550 mg BID for 6 weeks followed by~     surgical resection at 6 weeks. If there is no evidence of progressive disease at 6 weeks~     (clinical, radiographic or histopathologic exam), the patient will continue on IDH305 at 550~     mg BID post-operatively for a maximum of 11 additional 28 day cycles. Subsequent assessment~     of disease will occur every 2 months starting in Cycle 2.~      Cohort B - patients who have inoperable tumors but measurable 2HG pre-treatment will be~     treated with IDH305 at 550 mg BID x 6 weeks. If there is adequate sustained knockdown of 2HG~     on MRS and disease is stable or improved, then the patient will continue on treatment for a~     maximum of 11 additional 28 day cycles.~   "
5429|NCT02986594|"~     In this clinical cohort study, the investigators observe the efficacy of low molecular~     weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a~     prospective randomized controlled trial.~   "
5399|NCT02986997|"~     Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged:~     it begins in the lithotomy position for ureteral catheter placement and retrograde~     pyelography and, subsequently, an optimal renal access is obtained in the prone position. In~     most of the centers, the PNL is done under general anesthesia (GA) that is associated with a~     risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a~     prone position. In our Department the procedure is usually performed under epidural~     anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL~     over the last decade in the Medical University of Warsaw Urology Department~   "
5400|NCT02986984|"~     This is a prospective, observational, cohort study of patients with a clinical diagnosis of~     diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect,~     process, and study kidney tissue and to harvest blood, urine and genetic materials to~     elucidate molecular pathways and link them to biomarkers that characterize those patients~     have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser~     degrees of kidney function change over the period of observation. High through-put genomic~     analysis associated with genetic and biomarker testing will serve to identify key potential~     therapeutic targets for DKD by comparing patients with rapid and slow progression patterns.~     Each participating clinical site will search for, consent, harvest the biopsy sample, and~     enroll the participants as required for the TRIDENT protocol.~   "
5401|NCT02986971|"~     There are no implant removal devices on the market by any manufacturer. New features are~     described in comparison with the existing removal technique. Overall, the RemovAid™ combines~     the features of fixation, incision and extraction. This combination of functions has not~     previously been combined in a single device.~      The investigators wish to perform this pilot clinical investigation with the aim to~     demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and~     effectively facilitate implant removal. Other aims are to show that the IMD have the~     potential to reduce procedure length variability, reduce procedural complexity and reduce~     the need for additional procedural equipment related to CI removal procedures, without~     causing any harm to the subject.~   "
5402|NCT02986958|"~     This study evaluates an agenda-setting checklist for patients with cognitive impairment and~     their family companions that is completed in the waiting room in advance of a primary care~     visit. The study team will conduct a two-group randomized trial to examine feasibility of~     the protocol and to compare medical communication (from visit audiotapes) during visits of~     patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who~     receive usual care (n=50)~   "
5403|NCT02986945|"~     The purpose of the study is to test an experimental method, a text-messaging app called~     B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app~     adaptation of a Resiliency Course, developed by community members known as Building~     Resiliency and Community Hope.~   "
5404|NCT02986932|"~     This is a prospective, non-randomized, single-arm, feasibility study to evaluate the safety~     and initial effectiveness of opening of the Blood-Brain Barrier with intravenous contrast~     agents using the ExAblate Neuro System in patients with early stage Alzheimer's Disease.~   "
5405|NCT02986919|"~     Establish safety and toxicity profile and preliminary response rate of CPI-0610 in MPNST~     patients and correlate response with pharmacodynamics markers and BET inhibition.~   "
5406|NCT02986906|"~     Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.~     Although many conservative managements of UNE, the effectiveness of these methods are~     unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural~     injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment~     for entrapment neuropathy. However, current studies have not proved the effects of PIT on~     peripheral neuropathy because these studies enrolled small number of patients and lacked~     controlled design. We design a randomized, double-blind, controlled trail to assess the~     effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.~   "
5407|NCT02986893|"~     The goal of this project is to establish the feasibility of dietary research in Multiple~     Sclerosis (MS) patients as well as to provide preliminary data to support future clinical~     trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in~     MS patients. The dietary intervention was designed to include dietary components that have~     been suggested to be of benefit in MS through basic science research and observational-type~     studies in MS patients and to exclude those that have been suggested to be detrimental. It~     is therefore rich in foods that are high in polyunsaturated fatty acids (particularly~     omega-3 fatty acids), foods that are high in polyphenols and antioxidant vitamins such as~     berries and other fruits and vegetables, as well as whole grains, and excludes meat other~     than fish as well as dairy and refined sugars and limits salt. Subjects are randomly~     assigned to the dietary intervention or to the non-intervention group. The non-intervention~     group will be invited to attend regular meetings with a focus on wellness in MS however will~     not receive specific dietary instructions. At the end of the study those who were not in the~     dietary intervention group will have the opportunity to receive all of the materials used~     during the study should they wish to begin the diet.~   "
5408|NCT02986880|"~     The main objective of the study is to estimate the efficiency and to determine the optimal~     dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after~     radiotherapy, as well as the optimal sites for these injections.~      The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and~     the splenius capitis.~   "
5409|NCT02986867|"~     The study is an exploratory prospective, single center study with correlative endpoints. The~     study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core~     biopsies will be processed and analyzed as described above. Medical records electronic~     medical records will be used to collect demographic and medical information and imaging~     studies.~   "
5410|NCT02986854|"~     The purpose/aim of this study is to assess the safety and antibody response to vaccination~     with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to~     assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve~     subjects~   "
5430|NCT02986581|"~     The purpose of this study is to collect data of rapid response team activated patients~     prospectively~   "
26205|NCT02714153|"~     To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics)~     within the Superior Vena Cava in lead extraction patients.~   "
5411|NCT02986841|"~     This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements~     (CDEs) in primary care settings. The study will be conducted at three adult primary care~     clinics, in two large health systems. Each phase will include deliverables essential to move~     to the next phase, and an independent Advisory Committee will review progress and make~     recommendations at each transition about how best to progress to each subsequent phase.~     Based on progress during earlier phases, the Advisory Committee may recommend expansion to~     additional clinics or health systems during the second part of Phase 4.~      Phase 2 prepares for implementation of the screening and CDS tools as part of routine~     clinical practice. A key component of this phase is tailoring the screening and CDS tools~     through an iterative process of usability testing and adaptation of their design. In the KTA~     framework, this phase corresponds to the 'select, tailor, and implement interventions' step.~     Simultaneously, investigators will plan for implementation in one clinic of the MSHS system~     by identifying clinical champions, educating clinic leadership and staff, and conducting a~     workflow analysis to identify barriers and facilitators of implementation.~   "
5412|NCT02986828|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. Although many~     conservative managements of CTS, the effectiveness of these methods is insignificant or only~     persist for a short duration. The platelet rich plasma (PRP) is a new and potential~     treatment for patients with kinds of musculoskeletal disorders and recent reports showed~     being beneficial for peripheral neuropathy in animal studies. Since 2014, three small~     clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a~     pilot research. However, these studies have not entirely proved the effects of PRP on~     peripheral neuropathy because these studies enrolled small number of patients and lacked~     controlled design. The investigators design a randomized, double-blind, controlled trail to~     assess the effect after ultrasound-guided PRP injection in patients with CTS.~   "
5413|NCT02986815|"~     At each point that the patient will have [11C]-Acetate PET study, this will be compared with~     standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide~     (chemotherapy)~      Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will~     be analyzed qualitatively by visual assessment, quantitatively using a standard uptake value~     (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained~     by compartmental modeling of dynamic data.~   "
5414|NCT02986802|"~     Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant~     death and illness, affecting 500,000 births with annual medical costs of more than $26~     billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is~     considered a top research priority. Recent research has shown genital herpes infection (HSV)~     is associated with increased risks of PTD and LBW. More importantly, treating this~     infection, including infection with no symptoms, using readily available antiviral~     medications can be effective in removing the risk due to HSV. Thus, early identification and~     treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW.~     Currently, many pregnant women with HSV infection, especially those with no symptoms, choose~     not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general~     hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus,~     emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if~     untreated, and treatment effectiveness by anti-herpes medications has significantly changed~     current treatment paradigms among pregnant women. This evidence also provides new hope that~     effectively treating HSV infection among pregnant women, especially before the 3rd~     trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic~     disparities in these risks due to high rates of the infection in minority groups. Thus, to~     further examine the effectiveness of treating HSV in pregnant women to reduce adverse~     pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a~     two-stage design combining the large pregnant women population (N=90,000) in Stage I~     identified through Kaiser Permanente Northern California (KPNC) electronic medical records~     (EMRs), with a Stage II sample to collect detailed information on additional factors that~     might muddle our understanding of this issue. This study will address the following: (1)~     Does treating HSV infection in pregnant women reduce the risk of PTD or LBW? (2) Does timing~     of the treatment during pregnancy influence treatment effectiveness? (3) Do other factors~     influence treatment effectiveness? and (4) Does HSV infection in pregnancy, if untreated,~     increase the risk of PTD and LBW, compared to no infection? Answers to these questions will~     be valuable to pregnant women and clinicians, and directly address their concerns when~     making treatment decisions~   "
5415|NCT02986776|"~     A prior study in a tightly controlled clinical research environment found individuals with~     an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care,~     if they presented with high alcohol involvement and/or low cognitive functioning. This study~     sought to: (a) validate and extend these findings within the uncontrolled environment of a~     community-based treatment center, and (b) test whether inpatients had fewer days of~     involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need~     for inpatient treatment, using prior cut-points for alcohol involvement and cognitive~     functioning, participants were randomly assigned within inpatient need group (No Need for~     IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of~     outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were~     conducted an 90-day intervals across 18 months.~   "
5416|NCT02986763|"~     An association has been suggested with several diseases including cancer and IARC has~     classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a~     better characterisation of environmental pesticides exposures and identification of suitable~     biomarkers of exposure and effect. A better understanding of the impact of pesticide~     exposure on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen~     epidemiological hypotheses on the association with several cancer types.~      The main objective of the project is to validate a GIS (geographic information system) based~     method to assess environmental pesticide exposures, using environmental (contamination of~     housedust) and biological (blood and urine samples) measures. The project aims further to~     investigate a potential link between housedust contamination and biological measures in~     healthy non-smoking male residents and explore the impact of environmental pesticide~     exposure on metabolomics, transcriptomic and epigenetic parameters.~   "
5431|NCT02986568|"~     The purpose of this study is to compare standard treatment and fusion ontogenetic surgery~     (total mesometrial resection, laterally extended endopelvic resection, peritoneal~     mesometrial resection) for gynecologic cancer in order to evaluate treatment response,~     adverse effect and survival.~   "
5432|NCT02986555|"~     Current virtual reality device makes motion sickness and visual fatigue having limitation~     for recreation and other clinical approaches. Still there is no standardized quantification~     of motion sickness and visual fatigue measurement with objective approach. Current~     biofeedback accompanied with virtual reality would be promising tool for stress relief.~   "
7089|NCT02964429|"~     The main purpose of this study is the determination of the in-vivo ultrafiltration~     coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription~     in the United States.~   "
5417|NCT02986750|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, exact information about influence on tear film thickness and corneal~     residence time of topical lubricants is still sparse, therefore no ideal treatment regimen~     has been found.~      Recently a new method for assessment of tear film thickness based on ultra-high resolution~     optical coherence tomography (OCT) has become available. The aim of the present study is to~     assess the influence on tear film thickness of three different formulations of topical~     lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye~     Drops in patients with moderate to severe dry eye disease. In addition, standard tests for~     dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal~     fluorescein staining and determination of tear break up time (BUT) will be performed to~     compare the product effects.~   "
5418|NCT02986737|"~     Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP~     Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the~     Safety and performance of the study device~   "
5419|NCT02986724|"~     The purpose of this non-interventional study (NIS) study is to assess further knowledge on~     the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in~     participants with CD and UC naive to biologics.~   "
5420|NCT02986711|"~     This study aims to pilot a method of collecting the post-discharge follow-up data required~     by the Joint Commission Tobacco Measure Set, using text messages sent to and received from~     patients' cellular-telephones. It also aims to assess whether specially designed relapse~     prevention text messages designed to encourage abstinence from smoking, can increase the~     proportion of smokers who remain abstinent during the first month after discharge from~     hospital.~   "
5421|NCT02986698|"~     The investigators aims to evaluate the safety of in utero hematopoietic stem cell~     transplantation in fetuses with alpha-thalassemia major performed at the time of in utero~     transfusion of red blood cells.~   "
5422|NCT02986685|"~     The research aims to investigate whether trimebutine maleate combined with rabeprazole can~     improve the clinical efficacy in patients With refractory Los Angeles grade A or B reflux~     esophagitis . A total of 500 patients with Grade A or B reflux esophagitis refractory to~     rabeprazole will be randomly divided into two groups.One will continue to receive~     rabeprazole treatment,and the other group will receive extra oral trimebutine maleate 200 mg~     three times daily for 4 weeks. The end of the study for every patient is the improvement of~     main symptoms. The primary and secondary analyses are the main symptoms score, endoscopy~     results, Gastroesophageal reflux disease questionnaire（GerdQ) score,Hospital Anxiety and~     Depression Scale(HADS) score, Athens insomnia scale and World Health Organization Quality of~     Life-Bref(WHOQOL-BREF)scale scores at the baseline and final assessments.~   "
5423|NCT02986672|"~     This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty~     acids on children aged from 6-13 years, with ADHD/ADD and related symptoms. The study is a~     randomized, double-blind placebo-control study including approximately 330 children from~     Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers~     and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months~     post treatment). The secondary outcome measures are reading and writing disabilities,~     cognitive functions, and physical Health.~   "
5424|NCT02986659|"~     Medical scientists have found that people with diabetes who take the drug Metformin have~     less age-related disease than those taking other treatments and researchers believe it may~     prevent numerous diseases and conditions that effect older people. In addition, metformin~     extends lifespan in some animal models of human disease. The purpose of this study is to see~     if taking Metformin causes changes in blood cells consistent with improved health and~     longevity in people who do not have diabetes. In this study Metformin will be compared to~     placebo. A placebo is a substance, like a sugar pill, that is not thought to have any effect~     on a participants disease or condition. In this study participants will either receive the~     active study medication, Metformin or placebo which is not active. Placebos are used in~     research studies to see if the drug being studied really does have an effect.~   "
5425|NCT02986646|"~     Lateral epicondylitis, commonly known as tennis elbow is a common cause of elbow pain~     encountered in primary care and specialty clinics. Although lateral epicondylitis is common,~     little consensus exists on the best way to treat it. Historically 80% of patients will get~     better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to~     efficacy of injections, recent large, prospective, randomized studies have shown minor~     improvements in the short term, but no long term benefits when compared to saline injection.~     Consistently, intra-articular injections have not been reported. The investigators suspect~     that elbow joint inflammation may be an underappreciated source of pain in lateral~     epicondylitis. The investigators' hypothesis is that patients receiving intra-articular~     injections will have greater improvement compared to patients receiving either no injection~     or an intra-tendinous injection.~   "
5426|NCT02986633|"~     The present observational prospective study aims at identifying echocardiographic parameters~     (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV)~     ascertained using new methods of echocardiography including speckle tracking strain) that~     are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome~     following CRT~   "
5427|NCT02986620|"~     This is a study where there are no interventions planned. Investigators will only collect~     data already in the patient's history and analyze it. Particularly, we are interested in~     molecular data from AML patients.~      This means that patients will follow their regular diagnostic and clinical practice. The~     analyses will be conducted according to the routine diagnostic and clinical practice as well~     and no additional blood withdrawal will be performed.~   "
5428|NCT02986607|"~     The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal~     activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the~     renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality~     of life. The main objective of the current study is to test if PTH deficiency influences the~     secretion of corticosteroids and whether any abnormalities in the HPA-axis and the~     RAAS-system can be reversed by PTH infusion.~   "
21053|NCT02781584|"~     The primary objective of this study is to evaluate the safety and tolerability of~     selonsertib (GS-4997), GS-0976, and GS-9674 in adults with nonalcoholic steatohepatitis~     (NASH).~   "
5433|NCT02986542|"~     The use of USI has eased practical application of interventional procedures, and reduced~     complications and procedure durations. For vascular interventions with ultrasound imaging,~     short- or long-section imaging of vascular structures is performed. Both techniques have~     their own advantages and disadvantages.~      This study aims to compare the success rates of femoral artery catheterization using both~     imaging techniques.~   "
5434|NCT02986529|"~     To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after~     administration of single oral doses of 900mg in healthy Male subjects.~   "
5435|NCT02986516|"~     Comparative study on surgery versus definitive radiation therapy in primary localized sacral~     chordoma~   "
5436|NCT02986503|"~     The study is a first step of a process to establish the standard chemotherapy treatment with~     the aim to improve outcome for patients with these rare tumours. For this reason the study~     will be non-controlled clinical trial.~      In this regard, the study aims to determine the feasibility of intensive chemotherapy in~     this age group, and/or separate efficacy analyses according to the different histologic~     categories and whether the number of patients recruited by the co-operating groups permits~     future randomised studies.~   "
5437|NCT02986490|"~     Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia,~     dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic~     could be accompanied by a decrease in the concentration of serum magnesium. Low serum~     concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock,~     2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are~     multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate~     metabolism. Most studies on the subject have generally studied plasmatic magnesium.~      Objective : Describe the relationship between changes in serum and intra-erythrocyte~     magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A~     secondary objective is to specify the frequency, magnitude and time to onset of changes in~     plasma of magnesium levels under antipsychotic treatment.~      Methods : This is a pilot single-center prospective cohort. After inclusion, patients status~     (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status~     will define the exposure criterion. Included patients will be followed for 1 year during~     which cardiometabolic markers will be measured.~      Population : patients who are more than 18 years old with schizophrenia schizoaffective~     disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months~     and requiring the introduction of antipsychotic drug therapy. Patients will be recruited~     during consultations and stays in care units of Adult Psychiatry Unit of Montpellier~     University Hospital.~      Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the~     antipsychotic treatment measured by a unique analyzer center. Changes in levels of~     hypomagnesemia expected during the treatment will determine exposure groups.~      Outcome: cardiometabolic risk markers measured at the beginning and during the treatment~     will be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol /~     L) / 22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG~     (QTc).~      Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet,~     physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and~     comedications.~      Perspectives : to show that decreased in magnesium levels observed among patients starting~     antipsychotic treatment is associated with deterioration of cardiometabolic risk markers.~     The demonstration of this association could explain at least part the increased~     cardiovascular risk observed in this population. In the longer term, the results of this~     study would argue the implementation of an intervention research project studying magnesium~     supplementation to minimize the metabolic effects of antipsychotic medications.~   "
5438|NCT02986477|"~     In children, specifically the intravesicle administration to study vesicoureteral reflux in~     children already catheterized and scheduled for voiding cystourethrogram (VCUG).~     Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and~     color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of~     physiology and pathophysiology with higher resolution and accuracy in children. The~     technique is particularly useful in pediatric population whose lifetime risk of cancer~     significantly increases with higher frequency of ionizing radiation. Voiding~     cystourethrogram is a fluoroscopy technique that can study reflux real time but at the risk~     of radiation side effects. In this regard, intravesicle administration of ultrasound~     contrast agent can help avoid radiation in children and potentially replace the~     conventionally used voiding cystourethrogram.~   "
5439|NCT02986464|"~     Procedural pain is the most intense and often undertreated pain associated with burn~     injuries. The use of analgesics does not always provide optimal relief and is accompanied by~     several side effects. Indeed, children with burn injuries still experience severe pain~     intensity during procedures despite the fact that doses of analgesics used with this~     population has almost doubled in the last twenty years. Current guidelines on pediatric~     procedural pain management recommend the combination of non-pharmacological and~     pharmacological interventions to enhance pain management and decrease the numerous side~     effects of analgesics. Distraction has been identified among the most effective~     non-pharmacological interventions for pain as it diverts the child's attention to an~     attractive element, hindering the perception of the painful stimuli. Virtual reality is a~     method of active distraction that offers the child a multi-sensory immersive interaction~     that found many applications for pain management in adult patients. However, very few~     studies have tested the efficacy of distraction by virtual reality on procedural pain and~     anxiety in children with burn injuries.~      This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual~     reality prototype developed specifically for the hydrotherapy room of children under seven~     years old for the relief of procedural pain in children with burn injuries. The aim of the~     RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving~     procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for~     burn injuries.~   "
5440|NCT02986451|"~     This phase II study investigating the efficacy and safety of a combination of~     biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.~   "
5441|NCT02986438|"~     The purpose of this study is to investigate the short and long term clinical and cognitive~     effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz~     frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to~     examine possible changes in brain structure and functional connectivity associated with this~     intervention.~   "
5442|NCT02986425|"~     The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the~     Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant~     (STRIPA) implemented by an appropriately qualified team will lead to an improvement in~     clinical and economic outcomes among patients aged 70 years and more with multimorbidity and~     polypharmacy.~   "
5469|NCT02985580|"~     Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory~     properties, which in rodent models are neuro-protective. The risk of developing dementia is~     reduced in people habitually consuming high flavonoid intakes, but data from human~     intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry~     concentrate supplementation improved cognitive function in healthy elderly via increased~     brain activation and perfusion.~   "
5443|NCT02986412|"~     We would suggest to conduct VOLUME-2 study, as an extension of the ongoing VOLUME study~     with all subjects already included. After completion of VOLUME study, the study will be~     directly extend with an open-label design. All participants, who agreed to pursue, with~     either Placebo or CG428, will receive CG428 treatment for an additional six-month~     period. VOLUME-2 study would be ideal and timely by enabling no interruption of product use.~      The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months :~     6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder~     populations.~      Secondary Objectives are :~        -  Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant~          progression)~        -  Evaluate motivation and adherence of subjects~        -  Long term safety~   "
5444|NCT02986399|"~     The study examines if the introduction of a fast track pathway for hip fracture patients had~     an influence on mortality and quality of life by comparing these outcomes between all hip~     fracture patients operated at Akershus University Hospital two years before and two years~     after this change in standard care.~   "
5445|NCT02985905|"~     Although several studies have considered the relationship between infertility and semen~     thiol compounds levels, no study on the effects of asthenospermia treatments such as oral~     zinc supplementation on thiol related enzymes activity which are important in fertility of~     the individual has been reported.~   "
5446|NCT02985892|"~     The incidence of chronic nonspecific low back pain is the highest in the world population~     and can lead to disability. One of the standards treatments for this condition is the~     segmental stabilization exercises, as well as trunk stretching. However, there is no study~     that associates these two treatments for nonspecific low back pain. This study will be a~     controlled clinical trial, randomized, prospective, single-blind with a quantitative~     approach that compares the efficacy of the association between segmental stabilization +~     trunk stretching with segmental stabilization + placebo stretching in patients with chronic~     nonspecific low back pain.~   "
5447|NCT02985879|"~     The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics~     of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).~   "
5448|NCT02985866|"~     The objective of the study is to assess the efficacy and safety of home use of a~     Control-to-Range (CTR) closed-loop (CL) system.~   "
5449|NCT02985853|"~     The goal of this project is to examine the physical mechanisms that contribute to~     improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types~     of bariatric surgery.~   "
5450|NCT02985840|"~     Nausea is a common complaint in patients who present to the emergency department (ED).~     Although the number of conditions that can present with nausea are numerous, the mainstay of~     treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but~     also its availability. One of the major drawbacks to using this form is that it often needs~     to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV~     ondansetron given with IV dexamethasone (Decadron) as another viable option when treating~     patients with nausea in the emergency department.~      Previous studies in patients undergoing surgical procedures have shown that when IV~     dexamethasone is given with IV ondansetron to post-operative patients they have less nausea~     and vomiting than ondansetron alone, and were even found to show decreased post-operative~     pain associated with nausea. It has also been shown to decrease the need to re-dose~     antiemetic medication. Although this combination has not been tested in the emergency~     department it is believed by these investigators that the additional use of dexamethasone~     may decrease the need to use repeated doses of ondansetron.~      The investigators believe this may change the way physicians currently approach the~     nauseated patient in regards to treatment. That rather than possibly giving multiple doses~     of one medication over and over to reduce a patient's nausea, physicians can give two~     medications together at one time. The investigators hope to demonstrate that by giving~     intravenous dexamethasone and ondansetron together, it may be possible to reduce the number~     of patients who need additional doses of nausea medication.~   "
5451|NCT02985827|"~     The purpose of the study is to analyze the sensation to eye drops containing menthol in~     people with healthy eyes and in people with dry eyes. This study also examines the~     temperature of your eye using an Infrared Camera.~   "
5452|NCT02985814|"~     Background: Asthma and COPD are considered different diseases but many patients share~     characteristics of both entities. This has been termed COPD-asthma overlap syndrome.~      Study objective: To examine: (a) the frequency of the overlap phenotype among patients~     referred for pulmonary function testing and, (b) the impact of this phenotype on the~     therapeutic management and the quality of life of these patients as compared with patients~     with COPD only and asthma only.~      Methods:~      Type of study: Observational, cross-sectional. Study subjects: Patients referred for~     pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign~     an informed consent.~      Study procedures: Spirometry will be performed before and after the administration of a~     bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history~     of asthma and wheezing, current medications and history of exacerbations will be~     administered at inclusion. Questionnaire on medication utilization will be administered by~     telephone one month after inclusion. Quality of life: Will be assessed using the Saint~     George Respiratory Questionnaire (SGRQ).~      Working definitions: The following definitions will be adopted: a) COPD only: smoking~     history > 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of < 0.70; b) Asthma~     only: (1) presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or~     FVC of 12% and 200 ml; (2) prior physician diagnosis (before age 40); and c) both~     COPD-Asthma (the overlap group) - the combination of the two.~      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.~     Patient-reported outcomes will include the utilization of medication, the number of~     exacerbations, and quality of life.~   "
5453|NCT02985801|"~     Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in~     patients with unresectable pancreatic cancer?~   "
5454|NCT02985788|"~     Loss of elbow range of motion can significantly affect activities of daily living. Measuring~     elbow range of motion is critical for tracking post surgical outcomes. This study seeks to~     validate the ability to validate self photography as a means of followup through long~     distance correspondence.~   "
5470|NCT02985567|"~     The study involves a prospective evaluation of chloral hydrate sedation for the measurement~     of intraocular pressure in children ages one month to five years of age.~   "
5455|NCT02985775|"~     Cytomegalovirus (CMV) infections remain an important cause of morbidity and mortality in~     allogeneic hematopoietic cell transplant (HSCT) recipients, especially in patients received~     haploidentical transplantation. During the past decades, prophylactic or preemptive~     treatment with antiviral drugs has significantly reduce the incidence of early-onset CMV~     infection. Unfortunately, prolonged antiviral treatment is associated with substantial~     toxicity and may delay recovery of virus specific immune responses, resulting in an~     increasing of late-onset CMV disease.~      To date, adoptive immunotherapies have been developed as treatment alternatives to antiviral~     agents for CMV infection after HSCT. Studies have demonstrated that prophylactic or~     preemptive therapy with donor CMV-specific T cells can restore antiviral immunity and clear~     CMV viremia after transplantation. In this prospective clinical phase I/II trial, we propose~     to reconstitute antiviral immunity against CMV by preemptive transfer of CMVpp65-specific T~     cells (CMV-CTLs) at an early time point after allogeneic stem cell transplantation. We also~     propose to demonstrate whether protect against CMV is associated with recovery of CMV-CTLs.~   "
5456|NCT02985762|"~     The primary objective of this study is to characterize the pharmacokinetic (PK) profile of~     EXPAREL when administered via local wound infiltration to subjects undergoing open spinal~     fusion or reconstructive surgery.~      The secondary objectives of this study are to assess the safety, tolerability, and efficacy~     of EXPAREL in this surgical model.~   "
5457|NCT02985749|"~     This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment~     for social impairment in children and adults with high functioning autism spectrum disorders~     (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in~     improving social deficits in individuals with ASD.~   "
5458|NCT02985736|"~     A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice~     daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis~   "
5459|NCT02985723|"~     The aim of the present study is to evaluate the postoperative visual acuity for distance,~     intermediate and near vision as well as the cylinder correction and the patient satisfaction~     after bilateral implantation of AT LISA tri toric 939MP IOLs.~   "
5460|NCT02985710|"~     Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel~     noninvasive method to detect sudomotor dysfunction. Several small studies have recently~     shown that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes~     mellitus) can be performed non-invasively, quickly and effectively. The investigators aim to~     study the use of Sudoscan in rare disease condition associated with small fiber~     polyneuropathy.~   "
5461|NCT02985697|"~     The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine~     when used in combination with oral midazolam and/or nitrous oxide for moderate sedation~     during pediatric outpatient dental procedures.~   "
5462|NCT02985671|"~     The purpose of this study is to determine whether the fixed combination of orphenadrine,~     acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute~     episode of mechanical postural low back pain than Voltaren®. Will be randomized 110~     participants of both sexes, aged 18 years or older and less than 65 years of age with an~     acute episode of mechanical postural low back pain and they will be allocated to one of two~     treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and~     diclofenac sodium; or Group 2: Voltaren®~   "
5463|NCT02985658|"~     This is an expanded access protocol to allow continued maintenance therapy with ABT-888~     (veliparib) for three patients with metastatic triple negative breast cancer who are~     currently receiving the investigational product in association with clinical trial~     participation. Additionally, the protocol will enroll up to 7 new patients with metastatic~     BRCA associated or triple negative breast cancer to allow for additional access to veliparib~     monotherapy, or at the investigator's discretion, veliparib in combination with cisplatin~     and/or vinorelbine.~   "
5464|NCT02985645|"~     This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation~     with concentrated growth factor (CGF) utilizing dynamic implant valve approach (DIVA)~     system.~   "
5465|NCT02985632|"~     An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to~     evaluate pharmacokinetics in this patient population.~   "
5466|NCT02985619|"~     Background: Diabetic macular edema (DME) shows a sustained functional and morphologic~     response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal approach~     for persistent macular edema still in debate.~      Purpose: To evaluate 24-week visual and anatomical effects of intravitreal bevacizumabe or~     triamcinolone in patients who had residual edema after 24-weeks to pro re nata(prn)~     intravitreal bevacizumabe therapy.~      Methods: This study enrolled a total of 100 DME eyes. Each patient received prn~     bevacizumabe therapy throughout 24 weeks. At week 24, patients who had recurrent or~     persistent edema were randomized 1:1 to Group 1 (prn bevacizumane) or Group 2 (prn~     triamcinolone). Patients with no recurrent or persistent edema at week 24 were comprised~     Group 3 and continue received prn bevacizumabe. Prn treatment was administered when central~     subfield thickness of the macula (CST) > 300 µm and/or there were intraretinal cystoid~     spaces in the fovea. Study visits occurred every 4 weeks with the endpoint at week 48. At~     each visit, patients had an eye exam and CST, best-corrected visual acuity (BCVA), and~     intraocular pressure (IOP) were assessed. Fundus photography and fluorescein angiography~     were also performed at baseline, week 16, week 40, and week 48. Rescue therapy using laser~     photocoagulation could be administered at the discretion of the Investigators. All patients~     resumed standard care after exiting.~   "
5467|NCT02985606|"~     Investigate how manipulating the time between caffeine ingestion and exercise may alter~     exercise performance and cognition~   "
5468|NCT02985593|"~     The objectives of this study are to evaluate the safety and tolerability of a single~     intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a~     placebo-controlled, single-blind comparative study, and to evaluate the safety and~     tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an~     open-label study.~   "
5486|NCT02985359|"~     The goal of this evaluation is to assess the impact of a 3.5 year, World Food Program (WFP)~     supplemental child feeding and nutrition services program in reducing stunting and improving~     linear growth in children from 6 through 24 months of age in a rural district of Malawi.~   "
5471|NCT02985554|"~     This is an open-label, dose escalation Phase I study to evaluate the tolerability and~     efficacy of single agent of Nivolumab as maintenance treatment to prevent relapse in~     patients with hematologic malignancies after allogeneic stem cell transplantation.~     Approximately 29 patients will be enrolled, where about 6-12 patients will be included on~     the dose escalation phase and 20 patients will be on the expansion cohort at maximal~     tolerated dose.~   "
5472|NCT02985541|"~     The study is performed to assess if Mirena is effective and safe as a birth control method~     beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted~     for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.~   "
5473|NCT02985528|"~     Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound~     (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency~     diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR~     unforeseen diagnosis, provided by TUS, exploring usefulness and sustainability of~     telementoring aimed at the management of clinical risk. This observational report includes a~     period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis~     using freely available smartphone applications for the transfer of images and movies.~   "
5474|NCT02985515|"~     The purpose of this research study is to determine if budesonide nasal saline irrigation or~     smell training intervention impact sense of smell.~   "
5475|NCT02985502|"~     Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the~     reason why this form of surgery technique is seldom performed. However, with the progress of~     medical and surgical care nowadays, patients undergone TP could receive better care in~     endocrine and exocrine insufficiency. In addition, with better understanding of benign~     pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused~     pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the~     quality of life of patients with pancreatogenic diabetes after TP is still currently~     controversial.~      Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care~     activities and quality of life in patients with pancreatogenic diabetes after total~     pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.~      Method: A correlational and comparative cross-sectional approach will be used. The data will~     be collected with a structured questionnaire via purposive sampling of 120 subjects in an~     outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1)~     age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to~     participate in the study and sign informed consent. Exclusion criteria will be the patients~     diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go~     through propensity score matching and will be analyzed by using descriptive statistics,~     paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.~      Anticipated achievement: The anticipated achievement of this study is to understand the~     relationships between fatigue, self-care activities, and quality of life in patients with~     pancreatogenic diabetes after pancreas surgery. In addition, through this study, the~     influence of diabetes to patients after pancreatic tumor resection can be explored; and the~     factors that influence the population's quality of life can be examined. By the filling of~     this knowledge gap, intervention can be planned accordingly to help improve the population's~     quality of life.~   "
5476|NCT02985489|"~     Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will~     have fewer post-operative complications compared to malnourished patients that receive~     standard of care nutritional therapy.~   "
5477|NCT02985476|"~     This study evaluated the extent to which a shared health record facilitated better~     communication, increase individual responsibility for health care and reduce demand for~     health resources.~      The study made individualised reports available to patients and General Practitioners and~     gave much more detail about participants chronic disease and treatments, and evaluated its~     effectiveness in a randomised controlled feasibility trial.~      One third of patients received care as usual, two thirds of patients received the~     intervention.~   "
5478|NCT02985463|"~     Left Atrial Appendage Occlusion and Biomarker Evaluation (LABEL) is a single-center,~     prospective and observational study evaluating changes of the expression of biomarkers in~     eligible patients before and after percutaneous implantation of a left atrial appendage~     (LAA) occlusion device at mid-term follow-up.~   "
5479|NCT02985450|"~     (1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD~     in Canada do not have immunity to hepatitis B. (2) Adults with NAFLD who receive the HBV~     vaccine have reduced immunogenic responses in the setting of obesity (i.e., protective~     anti-HBs titres). Aims: (1) To determine the sero-prevalence of immunity against hepatitis B~     in a cohort of prospectively evaluated adult NAFLD patients. (2) To prospectively determine~     HBV vaccine responses (anti-HBs titres) in adult NAFLD patients.~   "
5480|NCT02985437|"~     Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in~     preterm infants. Here the drug is administered via airways.~      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is~     not yet approved for the treatment of wound healing disorders. In the planned clinical trial~     Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No~     substance related side effects were observed during the application via airways in neonates.~      The innovative idea to use lung surfactant for skin wound healing derived from two~     observations. First, when the skin is injured, the barrier protecting the moist body surface~     from the dry environment is discontinued and in part lost.~      Lung surfactant has several characteristics that might be beneficial for treatment of~     chronic cutaneous wounds.~   "
5481|NCT02985424|"~     The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose~     Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis~     pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia~     Rheumatica (PMR)/Giant Cell Arteritis (GCA) .~   "
5482|NCT02985411|"~     Gardening interventions yield a multitude of measurable benefits that are evaluable within~     the context of a clinical trial. Harvest for Health forges new inroads in the delivery of~     holistic interventions to high risk populations, in this case, older cancer survivors. Since~     the intervention banks on an existing organization's infrastructure, it can easily be~     disseminated nationwide. The next step is to prove efficacy - an essential step in~     contributing to the science in this area, and one which is crucial for future dissemination.~   "
5483|NCT02985398|"~     An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine~   "
5484|NCT02985385|"~     To prove that palliative therapy can be practised for congenital lethal malformations within~     the Islamic Code of Ethics.~      After defining lethal malformation no respiratory support is offered and newborns are~     provided with compassionate care.~   "
5485|NCT02985372|"~     This prospective multicenter clinical study was designed to assess the efficacy and safety~     of decitabine in combination with low-dose cytarabine induction treatment for elderly~     patients with newly diagnosed acute myeloid leukemia (AML).~   "
5487|NCT02985346|"~     Pulmonary hemosiderosis (PH) is a pulmonary hemosiderin deposition which caused by alveolar~     capillary hemorrhage. PH is easy to recurrent and can lead to pulmonary fibrosis and~     insufficiency if the disease was poor controlled. Steroid is the most common drug that was~     administered in acute phase of the disease. However, considered the side-effects, steroid is~     not suitable for long-time maintenance. Therefore, it is necessary to explore a new therapy.~     Bone marrow mesenchymal stem cells (BMSC) are a kind of adult stem cells with high~     self-renewal and multi-directional differentiation potential in bone marrow. It has become a~     hot topic in immunosuppressive and tissue repair therapy in recent years. To date, homing,~     colonization and differentiation of BMSCs in the lung have been observed in animal models of~     pulmonary hypertension, radiation pneumonitis and pulmonary fibrosis. It had been reported~     that BMSC transplantation in acute lung injury in mice, inflammation of lung injury can~     significantly improve. The aim of this study is to explore the effect of BMSC on PH and its~     mechanism, and to explore a new way to promote the repair of IPH. It is expected to improve~     the status of IPH therapy in children, especially improve the prognosis of refractory PH.~   "
5488|NCT02985333|"~     The purpose of this study is to evaluate the efficacy and safety of paclitaxel in~     combination with cyclophosphamide and dexamethasone in chinese patients with~     relapsed/refractory multiple myeloma.~   "
5489|NCT02985320|"~     The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,~     children and infants in a phase I open-label study, and then assess its immunogenicity and~     safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and~     controlled study.~   "
5490|NCT02985307|"~     This study evaluates the efficacy of a mobile telehealth short message service as a~     facilitator for weight management. Half of the participants will receive a standard care~     weight management group intervention, while the other half will receive daily text messages~     via their mobile phone to help facilitate weight loss. It is hypothesized that the~     intervention group receiving text messages will be as successful as the control group at~     achieving weight loss over a 3-month period.~   "
5491|NCT02985294|"~     This study evaluates peripheral nervous system function using Multiple Excitability Measures~     (MEM) to obtain electrophysiological pain phenotypes~   "
5492|NCT02985281|"~     Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian~     Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.~   "
5493|NCT02985268|"~     At present, the optimal treatment strategy for heart failure patients and moderate-to-severe~     (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is~     uncertain.Whether these patents should also be treated for functional mitral regurgitation~     or with CRT also remains unclear. We therefore propose a randomized 2x2 factorial design in~     this patient population to understand the the impact of both CRT and transcatheter mitral~     valve repair with the MitraClip on their functional status and quality of life.~   "
5494|NCT02985255|"~     Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment~     workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy~     along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice)~     with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third~     cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the~     PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group~     they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo~     adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further~     radiation and/ or chemotherapy will be decided based on the final histopathology (of the~     surgical specimen) reports.~      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment~     completion.~   "
5495|NCT02985242|"~     This is a prospective, randomized, active control, two-arm parallel, double-blind,~     monocenter phase IV clinical trial. The trial compares empagliflozin to glimepiride in~     patients with type 2 diabetes mellitus in addition to standard of care treatment.~      Patients with type 2 diabetes mellitus who are between 18 and 80 years of age will be~     recruited for the clinical trial and randomly allocated to either receive empagliflozin or~     glimepiride.~      The assumption of the study is that empagliflozin slows down diabetic retinopathy~     progression rate and thus a lower microaneurysm formation rate compared to subjects treated~     with glimepiride by substantially decreased cellular glucotoxicity will be achieved.~   "
5496|NCT02985229|"~     To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home~     administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70~     days LMP will be feasible and acceptable in Singapore.~   "
5497|NCT02985216|"~     A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the~     Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic~     Pain~   "
5498|NCT02985203|"~     This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety~     of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in~     Patients with advanced Non-Small Cell Lung Cancer.~      The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive~     combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the~     combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will~     be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy~     with metronomic oral Navelbine (Arm A) or other regimen (Arm B).~   "
5499|NCT02985190|"~     This study is a phase II of effcicacy and tolerance of azacitidine in patients with~     myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and~     inflammatory disorders~   "
5507|NCT02985086|"~     The primary aim of this study is to determine if antibiotics combined with immediate~     induction can significantly reduce the rate of maternal and neonatal infection compared with~     immediate induction alone in women presenting with PROM later than the 37+0 weeks of~     gestation. The secondary aim is to compare the rates of infection between immediate and~     delayed induction in women submitted to antibiotic prophylaxis.~   "
5508|NCT02985073|"~     This study compares the outcome using a biological mesh (Veritas®) compared to a non~     biological mesh (TIGR®) in immediate breast reconstruction.~   "
21204|NCT02779608|"~     This is a clinical Study to evaluate the effect, survival benefit and safety of~     intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant~     ascites.~   "
5500|NCT02985177|"~     MSK-I is the most common cause for ED visits for children with pain, with a child's risk of~     sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate~     moderate to severe pain in most children and the ED serves as the critical entry point for~     these injured children. This study aims to provide rapid and sustained pain management for~     children presenting with a MSK-I in the ED. The investigators will compare the efficacy of 2~     possible medication combinations (fentanyl intranasal + oral hydromorphone or fentanyl~     intranasal + oral ibuprofen) for the rapid, adequate and sustained pain management of~     children with suspected fracture.~      The investigators believe that the addition of HM to INF will lead to better pain treatment~     by providing a consistent and adequate level of analgesia throughout the entire ED visit,~     including prior to physician exam and during painful radiologic procedures.~   "
5501|NCT02985164|"~     Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a~     result, anesthetists become an inevitable target to the radiation exposure since they have~     to monitor patients closely during the operation. Unfortunately, radiation may not have an~     immediate sequelae, but an accumulation of adverse effects.~      These sequelae happen by means of direct exposure and reflection. The reflected rays is~     inversely proportional to the distance between the origin and the target. Practically, the~     radiation source can be protected by individual cover and glass shield.~      Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an~     Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio~     pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts~     visualisation is needed under anesthesia. Though the procedure is operated in a~     well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists,~     2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.~      During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from~     here and there. Though they always wear lead aprons and collar shields to protect themselves~     from the rays, they are normally in the position - less than 1 meter - close to the~     fluoroscopy.~      Due to the advancement in technology, anesthetists can remotely monitor patients during the~     surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether~     or not the positioning of anesthesia personnel relating to the distance of x-ray source~     would help to alleviate the effect of radiation exposure.~   "
5502|NCT02985151|"~     This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of~     the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has~     not had laser therapy may be eligible to participate. The visits occur every three months~     for up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment~     or a lower energy treatment during the study. Subjects and raters will be blinded to which~     therapy level the patient receives. At each visit, the scars will be photographed and the~     subject will complete a questionnaire to rate the scar prior to treatment. Three physicians~     will evaluate the scar at each visit. One rater will evaluate the scars in person during the~     visit, while the other two raters will evaluate the scars using photographs after each~     visit. During the first three study visits, subjects will receive their assigned treatment,~     obtain post-treatment instructions, and a diary to record redness, swelling, pain, itching,~     or other skin changes after treatment. At the third study visit, subjects will have the~     option to receive additional treatments or terminate their participation in the study. The~     fourth visit for those who continue will be a treatment visit for one group and the fifth~     visit will be for data collection, with no treatment offered.~   "
5503|NCT02985138|"~     TLIF is a popular lumbar interbody fusion technique to perform anterior interbody fusion.~     Pedicle screws providing initial stability have been developed to correct deformity, improve~     the rate of fusion and speed patient's postoperative recovery. Conventionally, an open~     approach is required, using bilateral pedicle screw fixation to provide stability as the~     gold standard. However, the increased stiffness of the fused segments will reduce the bone~     mineral content in adjacent vertebrae, and biomechanical studies have indicated that~     increased stress at the levels adjacent to the fusion may increase adjacent segment~     pathology. Therefore, unilateral pedicle screw fixation had been considered as a means to~     decrease the stiffness of the instrumented segment. Recently, researchers have shown that~     unilateral instrumented spinal fusion provides comparable results and is as effective as~     bilateral fixation. In addition, the cost-effectiveness of this approach is worthy of~     attention. To our knowledge, few randomized controlled studies comparing unilateral versus~     bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose~     of this study is to compare clinical and radiographic outcomes in a series of patients with~     lumbar degenerative diseases using instrumented TLIF with unilateral or bilateral pedicle~     screw fixation.~   "
5504|NCT02985125|"~     This study is a single-arm, open-label, multi-institutional Phase I/II trial of the~     combination of LEE011 and everolimus in refractory mPAC.~   "
5505|NCT02985112|"~     Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional~     flow reserve (FFR) which expresses the physiological significance of a lesion and tells the~     operator whether PCI may reduce the rate of adverse events as compared to medical therapy.~     Coronary stenoses with FFR value < 0.80 are indeed associated with a higher rate of adverse~     event and requires coronary revascularization whereas lesions with FFR > 0.80 show an~     excellent prognosis which cannot be improved by coronary stenting. Such a predictive value~     of FFR is theoretically based only on the degree of myocardial ischemia downstream from a~     given coronary stenosis: however, also plaque composition may play a crucial role in~     triggering future events especially in patients affected by acute coronary syndrome.~     Differences in plaque composition between FFR-positive and FFR negative lesions have never~     been assessed. Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques~     that can potentially cause acute events. The aim of this study is to compare the lipid~     content expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR <~     0.80) and non-significant (FFR > 0.80) stenoses in patients undergoing coronary angiography~     because of stable CAD and non-ST elevation acute coronary syndromes. This is an~     observational, prospective, multicentric study where we plan to collect 150 coronary~     lesions.~   "
5506|NCT02985099|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2%~     Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis~     (CP) with Type 2 diabetes mellitus patients.~   "
5510|NCT02985047|"~     The purpose of the study is to test a standardized version of brief admission (BA) through~     randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a~     crisis management model for individuals with recurrent self-harm, including suicide attempts~     and at least three symptoms of Borderline Personality disorder. Participants will be~     allocated to BA + Treatment as Usual (TAU) or TAU.~   "
5511|NCT02985034|"~     Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and~     characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas~     immediate technical success is usually assessed by CT. Conventional visual assessment of two~     modalities may be more challenging than being anticipated, because acquisition position,~     respiration, and spatial resolution differ between the two. Therefore, the study purpose is~     to evaluate the results of software-assisted ablative margin assessment using registration~     of different pre-and post-RFA modalities compared with the conventional method of~     side-by-side MRI-CT comparison in patients with HCCs.~   "
5512|NCT02985021|"~     In this study, patients who have metastatic prostate cancer that does not respond to hormone~     treatment and who have mutations in certain cancer-related genes will be treated with~     docetaxel and carboplatin chemotherapy.~   "
5513|NCT02985008|"~     Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic~     manifolds and investigated the current state of treatment and clinical features of~     cardiogenic shock in Koreans and identified the factors that could improve the prognosis and~     the use of IABP and ECMO And to investigate its therapeutic effect.~   "
5514|NCT02984995|"~     This is a Phase 2, multi-center, open-label, single-arm study to evaluate the efficacy,~     safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD~     positive refractory or relapsed acute myeloid leukemia.~   "
5515|NCT02984982|"~     Primary Objective:~      To compare the efficacy of alirocumab with standard of care on coronary atheroma progression~     in patients who have experienced an acute coronary syndrome (ACS) event and are treated with~     atorvastatin or rosuvastatin.~      Secondary Objectives:~        -  To compare the efficacy of alirocumab with standard of care on absolute change in~          percent atheroma volume (PAV) and normalized total atheroma volume (TAV).~        -  To evaluate the efficacy of alirocumab on low-density lipoprotein cholesterol (LDL-C),~          apolipoprotein B (Apo-B), triglycerides, non-high-density lipoprotein cholesterol~          (non-HDL-C) and Lipoprotein(a)(Lp[a]).~        -  To evaluate the safety of alirocumab including the occurrence of cardiovascular events~          (coronary heart disease [CHD] death, non-fatal myocardial infarction [MI], fatal and~          non-fatal ischemic stroke, unstable angina requiring hospitalization).~   "
5516|NCT02984969|"~     Constipation is a frequent, chronic gastroenterological problem that has many varied~     symptoms and thus has several clinical definitions. According to the Rome III criteria for~     chronic constipation, almost 16% of all adults are affected by chronic constipation~     worldwide, and it is more prevalent and symptomatic in women and elderly people. Slow~     transit constipation (STC) is the major category and is characterized by a decreased rate of~     colonic transit.~      Recently, many researchers have focused on the relationship between intestinal microbiota~     and constipation and have demonstrated that intestinal microbiota contribute to the~     pathophysiology of functional gastrointestinal disorders.~      Thus, there is a need for an improved understanding of gut microbiota composition in~     constipation patients and for the potential role played by the gut microbiota in the~     etiology of STC.To achieve this goal the investigators characterized and compared the~     intestinal microbiota among carefully selected patients with constipation that were~     clinically categorized based on Rome III criteria, and healthy controls using high~     throughput pyrosequencing of the 16S rRNA gene and a conservative approach to detect~     quantitative changes in the relative abundances of taxa.~   "
5517|NCT02984956|"~     Correct assessment of a patient's volume status is the most important goal for an~     anesthetist. However, most of the variables used for fluid response evaluation are invasive~     and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used~     monitoring method in many countries. Our aim in this study is to investigate the usefulness~     of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture~     patients who underwent spinal anesthesia.~   "
5518|NCT02984943|"~     The purpose of this investigation is to determine the effects and ease of using hyperbaric~     oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of~     disease progression. In this study it is our intention to not only evaluate effects and ease~     of treatment but time, cost, possible adverse events and effect size in an attempt to~     predict an appropriate sample size and improve on the study design prior to a more extensive~     study.~   "
5519|NCT02984930|"~     The gastric acid pocket is believed to be the reservoir from which acid reflux events~     originate. The risk for acidic reflux is mainly determined by the position of the gastric~     acid pocket. Little is known about how changes in position and size of the acid pocket~     contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in~     patients with gastroesophageal reflux disease. Investigators will conduct a prospective~     randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis~     that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing~     the acid pocket position and size.~   "
5520|NCT02984917|"~     To investigate the advantages and disadvantages of the anterior transversalis fascia~     approach versus the preperitoneal approach for inguinal hernia repair in residents from~     northern China regarding common postoperative complications (including acute and chronic~     pain, wound infection, rates of wound infection, hematoma, seroma, and hernia recurrence)~     and severe postoperative complications.~   "
5521|NCT02984904|"~     The aim of this study was to describe the clinical-epidemiological characteristics of a~     series of cases of fungal keratitis associated with Fusarium spp., In Spain during the years~     2012 to 2014.~   "
5522|NCT02984891|"~     Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly~     used and have been extensively studied separately to guide percutaneous coronary~     intervention and improve long-term outcomes. In this study, the investigators aim to~     directly compare high-definition IVUS images to OCT in the same patients to determine the~     differences between each modality as they relate to imaging coronary pathology, with the~     goal of determining which modality is most appropriate in particular clinical scenarios.~   "
5523|NCT02984137|"~     This is a prospective cohort study to evaluate degenerative changes in the brain by~     performing functional imaging analysis in patients with RBD and its correlations with~     clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes~     with functional imaging measures and olfactory and other premotor symptoms of Lewy body~     disease. This study also collects gene extracts and sera to develop a biomarker for early~     detection of neurodegeneration.~   "
5524|NCT02984865|"~     Gastrointestinal surgeries are common surgeries performed in elderly patients throughout the~     world. Although there is an increasing trend towards laparoscopic surgeries, open procedures~     continue to remain common therapeutic modalities especially in the developing countries.~     Pain is reported more commonly in patients undergoing open procedures than laparoscopic~     procedures. Postoperative pain and tissue injury associated with surgery initiated a~     systemic stress response which has neuroendocrine, immunological, and haematological~     responses. Opioids are an important modality of postoperative pain management. They blunt~     the neuroendocrine stress response to pain. However, they are associated with several~     adverse effects like respiratory depression, nausea, vomiting , pruritus, constipation,~     urinary retension, bradycardia and hypotension. Transversus abdominis plane block（TAPB）is a~     relative novel procedure in which local anesthetic agents are injected into the anatomic~     plane between the internal oblique and the transversus abdominis muscle. It allows a~     significantly prolonged duration of analgesia during the early postoperative stage in~     abdominal surgery. This regional anesthesia technique provides analgesia to the skin,~     muscles of the anterior abdominal wall and parietal peritoneum in order to decrease the~     incision-related pain. Thus, it reduces postoperative opiate requirements and~     opioids-related side effects (nausea, vomiting, delayed resumption of intestinal transit,~     drowsiness, respiratory depression, urine retention). Nalbuphine, being mu antagonist an~     kappa agonist, has a ceiling effect in its respiratory depression. Many studies have~     reported that incidence of adverse effects like pruritus and PONV is lower with nalbuphine~     in comparison with morphine. The purpose of this study is to compare the analgesic efficacy~     and side effect profile of sulfentanyl with nalbuphine in elderly patients undergoing open~     gastrointestinal surgeries.~   "
5525|NCT02984852|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and relative~     bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,~     Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a~     fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as~     Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed~     as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):~     a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with~     240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF~     (800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.~   "
5526|NCT02984839|"~     The aim of this prospective, observational study is to determine the incidence of~     post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal~     procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures~     that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As~     intra-abdominal surgeries are independently associated with post-operative pulmonary~     complications (PPCs), it is important to highlight other factors, such as PRNB, that could~     contribute to these complications.Although it has been shown that the risk of adverse~     respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring,~     such monitoring is not in widespread use.This study will incorporate quantitative monitoring~     in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to~     show a disparity in the incidence of residual paralysis between these two patient~     populations and to emphasize the need to implement more accurate neuromuscular monitoring,~     especially for those that are already at increased risk for respiratory complications.~   "
5527|NCT02984826|"~     Background:~      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.~     Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with~     trapezius myalgia. It is shown that specific strength training leads to prolonged pain~     relief.~      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients~     with TTH compared to healthy controls.~      Intervention: To investigate the effect of specific strength training on patients with TTH~     compared with control group, receiving training in ergonomics.~      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and~     shoulder. Testing conducted by blinded research assistant.~      Intervention group: 60 patients with tension headache randomly assigned to the intervention~     group or control group. Intervention with specific strength training program runs for 10~     weeks. The control group will be trained in ergonomics. 3 months follow up.~   "
5528|NCT02984813|"~     This study is a multi-armed protocol designed to evaluate the safety and efficacy of two~     different combinations of nutritional supplements (study drug) (Glauco-Health and~     Glauco-Select) chosen for their potential to protect retinal ganglion cells against~     oxidative stress, low-grade inflammation, and mitochondrial dysfunction in patients with~     open-angle glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular~     dysfunction will be measured using a Retinal Metabolic Analyzer (RMA) in this randomized,~     single center, double masked study. Patients with glaucoma will be divided into three~     treatment arms randomized to receive either Glauco-Health, Glauco-Select, or placebo.~   "
5529|NCT02984800|"~     Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its~     unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged~     postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,~     timely and effective technique generates the investigation of a single PVB injection for~     children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind~     this investigation. First, possible spread of single PVB injection in the lumbar area over~     dermatomes corresponding to the inguinal hernia region in children likewise the spread over~     multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal~     region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,~     all three arising from L1-L2 level; thus, a single PVB injection at this level could provide~     unilateral segmental anesthesia.~   "
5530|NCT02984787|"~     The investigators will perform a prospective randomized comparison between 3D and 2D~     laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.~   "
5531|NCT02984774|"~     The goal of the study was the detection of telomerase activity in eutopic, ectopic~     endometrial tissue and in peripheral blood and finding the correlation between the~     telomerase activity and clinic findings. With these results, confirmation of the hypothesis~     regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.~   "
6004|NCT02978599|"~     Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase,~     cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of~     AVL-3288 each compared to placebo, in patients with schizophrenia.~   "
5532|NCT02984761|"~     Patients with stage I non-small cell lung cancer have been historically treated with surgery~     whenever they are fit for an operation. However, an alternative treatment known as~     stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors~     believe both are good treatments and are therefore conducting this study to determine if one~     may be possibly better than the other.~   "
5533|NCT02984748|"~     The ability to predict post-operative outcomes after implantation is important for a number~     of reasons, including being able to advise candidates of appropriate expectations using~     evidence based guidance. The approved study involves investigation of the ability to predict~     outcomes in the implanted ear alone and in the best-aided binaural listening conditions,~     examining a number of measured factors both pre-, peri- and post-operatively. The study~     incorporates a range of functional outcome measures through questionnaires to ascertain~     social, functional and demographic factors that may be predictive of outcomes.~     Questionnaires are also administered to determine the degree of benefit obtained after~     implantation for each individual, since this forms a key component of providing~     pre-operative counselling to candidates.~   "
5534|NCT02984735|"~     The purpose of this study is to determine the association between gross motor function and~     chewing performance level in children with cerebral palsy (CP). A cross-sectional study was~     conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross~     Motor Function Classification System (GMFCS) was used to determine gross motor function~     levels of children. Chewing performance level was determined by using the Karaduman Chewing~     Performance Scale (KCPS).~   "
5535|NCT02984722|"~     The aim of our study is to compare the different effects of 6 months treatment with~     extended-release metformin and immediate-release metformin on clinical, endocrine and~     metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate~     gastrointestinal disorders associated with the two different compouds.~   "
5536|NCT02984709|"~     The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents~     have problems with adherence. The proposed study will pilot test a positive psychology~     intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment~     based on feedback from the first iteration of the intervention. The potential benefits~     include helping adolescents achieve better glycemic control, thereby reducing the health~     risks and complications associated with diabetes.~   "
5537|NCT02984696|"~     The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant~     capacity, clinical, endocrine and metabolic features in women affected by hypotalamic~     amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol~     daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six~     months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone~     metabolism parameters are evaluated before and after therapy.~   "
5538|NCT02984683|"~     Primary Objective:~      To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and~     safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected~     dose based on ORR.~      Secondary Objectives:~        -  To assess:~        -  Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival~          (PFS), and Time To Progression (TTP)~        -  The impact of ocular primary prophylaxis on the incidence of keratopathies;~        -  The potential immunogenicity of SAR566658~        -  To evaluate the global safety profile~   "
5539|NCT02984670|"~     The overall purpose with this investigation is to further our knowledge about cognitive~     behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and~     moderators. The first aim that will be addressed is to explore the efficacy of the CBT~     components with a dismantling-treatment strategy. Two active CBT interventions, intended to~     define its components - cognitive therapy and behavior therapy - will be compared with one~     another as well as with a waitlist condition on a broad range of outcomes at five to nine~     assessment points depending on the measures. The design will thus enable us to examine what~     CBT component or components are necessary, sufficient and facilitative of therapeutic~     change. The second aim that will be explored is to investigate what processes occur in CBT~     that may contribute to treatment outcome with a treatment-mediator strategy. To examine~     mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about~     sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep~     Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in~     bed, napping, bedtime variability, and rise time variability. The hypothesis is that~     cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors~     will have a mediating role for behavior therapy improvements. The third aim that will be~     addressed is to examine what patient characteristics does CBT depend on to be effective with~     a treatment-moderator strategy. To investigate moderators for CBT, the following moderators~     will be assessed; age, gender, occupational status, level of education, initial insomnia~     severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical~     co-morbidity, behavioral and cognitive processes used as mediators will also be employed as~     moderators.~   "
5540|NCT02984657|"~     The purpose of this study is to investigate whether intraoperative reverse Trendelenburg~     positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.~   "
5541|NCT02984644|"~     To determine the role of plasma glucagon and insulin in the rise of endogenous glucose~     production (EGP) following the SGLT2 inhibition.~   "
5542|NCT02984631|"~     In patients with heart failure, elevated filling pressures may contribute to symptoms while~     not improving cardiac output. The current study is focused on evaluating the relationship~     between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of~     dyspnea in patients with heart failure during exercise.~   "
5543|NCT02984618|"~     Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood~     patch for post dural puncture headache but the investigators do not know if it has~     significant efficacy when compared to epidural blood patch. Method: randomized trial where~     patients will randomly receive either sphenopalatine block or epidural blood patch. Pain~     relief to no pain or low intensity pain will be the main outcome~   "
5544|NCT02984605|"~     This study evaluates the nutritional meal replacement and individualized exercise~     prescription intervention on overweight and obese type 2 diabetes mellitus. Half of~     participants will receive nutritional meal replacement and individualized exercise~     prescription on the basis of conventional glucose-lowering treatment, while the other half~     will only receive conventional glucose-lowering treatment.~   "
5545|NCT02984592|"~     Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such~     as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and~     their partners. The current study was aimed to evaluate the relationship between ejaculation~     and physical activity.~   "
6005|NCT02978586|"~     The purpose of this study is to see if positron emission tomography/ magnetic resonance~     imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an~     investigational radioactive drug called [Ga-68]PSMA.~   "
5546|NCT02984579|"~     This is a multi-center, blinded study to determine the performance of the YD Diagnostic~     Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical~     isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB)~     and at risk of drug resistance. All testing was done on stored, de-identified leftover~     samples.~      The study involved three World Health Organization (WHO) Supranational Reference~     Laboratories with well-characterized strain collections and access to sputum samples with~     significant rates of drug resistance.~   "
5547|NCT02984566|"~     Primary and secondary liver cancer patients will receive liver SABR with or without KIM~     intervention.~   "
5548|NCT02984553|"~     The purpose of this study is to accurately assess weekly physical activity levels of~     postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.~   "
5549|NCT02984540|"~     The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a~     lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data~     collected will help determine changes in cognitive function, brain structure and function,~     and levels of certain proteins and hormones in body fluids.~   "
5550|NCT02984527|"~     The Purpose of the study is to compare the effectiveness on microbiological counts from skin~     swaps after wash with water and soap or wet wipes.~   "
5551|NCT02984514|"~     Brown adipose tissue has the capacity to consume large amounts of energy and has~     insulin-independent glucose uptake. The investigators have recently observed an inverse~     correlation between irisin levels and insulin needs of type 1 diabetes patients.~     Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood~     glucose levels.~      In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable~     exogenous insulin needs will be investigated for amount of brown adipose tissue with~     positron emission tomography using the tracer 18F-deoxy glucose.~   "
5552|NCT02984501|"~     There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic~     disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease~     with chemotherapy, as well as for the treatment of local disease with radiotherapy. The~     investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin~     and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation~     therapy in patients with borderline resectable and unresectable locally advanced pancreatic~     cancer~   "
5553|NCT02984488|"~     To evaluate the incidence and severity of postoperative pain after root canal therapy of~     necrotic teeth in one appointment versus two appointments using Protaper next instrument.~   "
5554|NCT02984475|"~     Beta Thalassemia is a major public health problem in Mediterranean countries.In Egypt, it is~     considered as the most common chronic hemolytic anemia.one of the major complications in~     this inherited disorder is iron overload which lead to oxidative stress and tissue damage.~      Regarding toxic effect of iron overload on liver, hepatomegaly is one of the most findings~     that resulting from hemosiderosis, extra medullary hematopoiesis, transmitted hepatitis B~     and C and cirrhosis.~      A lot of studies have been carried out recently to study the beneficial role of metformin in~     non-diabetic patients of different disorders as non-alcoholic fatty liver disease~     (NAFLD).Among several studies, it's demonstrated that metformin significantly improved~     insulin resistance, aminotransferase levels and liver morphology.~      The role of metformin in these studies is mainly thought to be antioxidant and~     anti-inflammatory effects. However, the role of Metformin on hepatic function in different~     populations with the same mechanism of liver injury should be further investigated.~      This clinical trial will be carried out on 60 patients with beta thalassemia major receiving~     regular blood transfusion and iron chelating therapy, either HCV positive or negative~     patients.~      They will be randomly distributed into either control group (group 1, n=30) receiving blood~     transfusion and taking iron chelating therapy or treatment group (group 2, n=30) receiving~     blood transfusion and taking iron chelating therapy along with metformin tablets (500~     mg/twice daily) for 6 months.~   "
5555|NCT02984462|"~     The study is a prospective randomized study about hallux valgus surgery. The investigator~     try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an~     incidence in the first ray mobility since the two technics ( fixation and no-fixation) are~     described and practiced, and since the stiffness of the first metatarso-phalangeal joint is~     determinant in the result of this functional surgery.~   "
5556|NCT02984449|"~     Rationale:~      Patients undergoing cardiac surgery are at risk of developing perioperative complications~     and major adverse cardiac events, mainly related to both their preoperative status and type~     of surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an~     effective therapy to prolong survival and improve quality of life. However, little is known~     about the effect on post-operative complications, quality of life and return to work of a~     combined pre- and post-operative CR program encompassing physical therapy, dietary~     counseling, psychological support and life style management compared to a CR program, which~     is provided only after cardiac surgery.~      Objective:~      to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up~     to three months) and long term outcomes (up to one year) of the cardiac surgery (i.e.~     reduction in postoperative surgical complications, readmissions to hospital and major~     adverse cardiac events in conjunction with improvements in the physical component of health~     related quality of life), when compared to postoperative CR only (POST).~      Study design:~      A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized~     between two standard care CR programs. One group will start a the POST CR program after~     surgery. The other group will be randomized to a combined PRE+POST CR program.~      Study population:~      Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery~     and/or aortic surgery~      Main study parameters/endpoints:~      The primary outcome is a composite weighted endpoint of postoperative surgical~     complications, re-admissions to hospital, major adverse cardiac events and health related~     quality of life (two domains: physical functioning and physical problem), at three months~     and one year after surgery. Endpoints are determined by an independent endpoint committee,~     blinded to the group allocation. Secondary, the study focuses on physical health~     (cardiorespiratory fitness, muscle strength and functional status), psychological health~     (feelings of anxiety and depression), work participation, economics, lifestyle risk factors~     (physical activity and smoking behavior), self-efficacy and illness representations.~   "
5557|NCT02984436|"~     This is a prospective observational cohort study of ED patients with acute chest pain or~     other symptoms suggestive of ACS. Blood samples will be collected from study participants~     for High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be~     used for research purposes only.~      Providers will be blinded to results and participants will be treated by their healthcare~     providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to~     ascertain study outcomes.~   "
5558|NCT02984423|"~     This study aims to answer very important questions regarding the prevalence of somatic and~     germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer~     patients from Latin America. These answers may be extremely helpful in the counseling for~     genetic risk and treatment approach in these populations and will aid in making treatment~     decisions in the future~   "
5559|NCT02984410|"~     Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of~     tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are~     usually cured. Treatment of early stage OPSCC can be successfully achieved with primary~     surgery including neck dissection, as indicated, or with definitive radiotherapy. The~     current standard treatment for OPSCC is therefore based on either surgery and/or~     radiotherapy, both associated with comparable, high tumor control rates but with different~     side effects profiles and technical constraints.~      In order to decrease the potential morbidity of surgery, transoral approaches have been~     developed within the last decades, including transoral robotic surgery (TORS), transoral~     laser microsurgery (TLM)or conventional transoral techniques. On the other hand, patients~     with head and neck cancer treated with IMRT experienced significant improvements in cause~     specific survival (CSS) compared with patients treated with non-IMRT techniques thus~     suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile.~     It is as yet unclear however, which one of the new techniques is superior to the other in~     terms of function preservation. Given that the functional outcome of most importance is~     swallowing function, the preservation of swallowing is thus of major importance.~      The main objective of the study is to assess and compare the patient-reported swallowing~     function over the first year after randomization to either IMRT or TOS among patients with~     early stage OPSCC.~   "
5560|NCT02984397|"~     Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in~     adolescents with severe CWP not responding to the standard of care (SOC) treatment program~     in a multidisciplinary tertiary care chronic pain clinic. The changes associated to the~     interventions (KF or placebo) will be quantified using the Patients' Global Impression of~     Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects~     of KF on the pain sensitivity, physical and emotional functioning, and we will also explore~     the potential biological underlying mechanisms.~   "
5561|NCT02984384|"~     The purpose of this study is to investigate the effectiveness of Low Molecular Weight~     Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary~     blood clots in patients who sustain trauma.~   "
5562|NCT02984371|"~     The aim of this prospective randomized study was to assess the efficacy of ablation of the~     ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial~     tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery~     bypass grafting.~   "
5563|NCT02984358|"~     Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,~     with or without a reduced nucleotide content, on markers of metabolic health, such as uric~     acid concentrations, blood glucose control and blood lipid profiles.~   "
5564|NCT02984345|"~     The present study will seek to quantify the muscle protein synthetic response to mycoprotein~     feeding, comparing it to milk protein as a gold standard and heavily researched positive~     control~   "
5565|NCT02984332|"~     The effect of unilateral lower limb immobilisation over one week on muscle atrophy~   "
5566|NCT02984319|"~     Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young~     men~   "
5567|NCT02984306|"~     Examining the effect of four weeks of cherry powder supplementation on flow mediated~     dilatation~   "
5568|NCT02984293|"~     Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe~     drugs. However, up to one third of statin users can experience muscle symptoms, which are~     most commonly mild without any conventional laboratory signs of muscle damage. However,~     these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy,~     reducing its effectiveness. Recent data has highlighted the potential role of immune system~     in development of statin-induced muscle pain. Variation in the LILRB5 gene has been~     associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic~     variability in tolerability and immune response to atorvastatin in healthy volunteers.~      The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in~     Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to~     GoSHARE study. The participants will be healthy, and recruited according to their genotype~     of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised~     cross-over study with two treatment periods. During treatment period one, all participants~     will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the~     treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire~     will be completed to assess the tolerability and immune response to the study drug exposure.~     After four weeks, the study drug is stopped for a washout period of three weeks before~     cross-over commences. Thereafter, during treatment period two, the alternate study drug will~     be started, and tolerability will be assessed similar to that in period one. The study will~     last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.~   "
5569|NCT02984280|"~     This study will investigate whether there is a population-level association between~     circulating respiratory viruses and NHS hospital admissions for acute vascular events using~     data from national infection surveillance and Hospital Episode Statistics.~   "
5570|NCT02984267|"~     Placement of labor epidurals is a very common daily practice in obstetrical anesthesia.~     Currently, these epidurals are placed based upon palpation of landmarks to determine midline~     and the correct spinal level for placement. Palpation of these landmarks can be difficult,~     however, particularly in morbidly obese patients who have significant amounts of soft tissue~     overlying them. This study seeks to use ultrasound guidance to examine the spine prior to~     epidural placement, and see what effects this has compared to palpation alone with respect~     to procedure time, number of attempts, success rate in the first attempt, failure rate,~     complication rate, patient anxiety levels, and patient satisfaction levels.~   "
5595|NCT02983929|"~     The main purpose of this study is to determine the influence of obesity on the short term~     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee~     arthroplasty. It is a retrospective, comparative study~      The secondary purposes are to explore the links between length of stay and short-term~     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee~     arthroplasty.~   "
6006|NCT02978573|"~     Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant~     established by the pivotal trial.~   "
5571|NCT02984254|"~     BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has~     received relatively little attention in the OA literature and there are few treatment~     options for individuals with patellofemoral OA. Patellar misalignment is associated with~     radiographic progression patellofemoral OA and symptoms and in magnetic resonance imaging~     (MRI), to cartilage loss measurements and bone marrow lesions. The hypothesis is that the~     correction of the patella disorder using strategies such as bracing or adhesive bandages can~     handle the symptoms and progression of OA.~      OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint~     compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.~      METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of:~     overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will~     be divided into two groups according to the knee brace that will receive: Functional Bracing~     patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both~     groups will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome~     and asked to do daily exercises in addition to reporting the daily consumption of drugs a~     month before placing the orthotics up to three months after placing it. They will be~     evaluated with the questionnaires WOMAC and Lequesne, and asked to perform the~     five-times-sit-to-stand-test, Timed-up-and-go (TUG) and the six-minute walk test in the~     moments immediately prior to placement of the brace, with one, three and after 12 months~     bracing.~   "
5572|NCT02984241|"~     This study evaluates web-based interventions to help women cope with the stress arising from~     living with a problem-drinking partner~   "
5573|NCT02984228|"~     Glenohumeral osteoarthritis (OA) accounts for approximately 2-5% of all chronic shoulder~     pain and may be classified into primary and secondary forms. Primary glenohumeral OA is~     caused by degenerative joint disease, inflammatory arthropathies, and neuropathic~     arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by~     trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis.~     Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective,~     and possibly anti-inflammatory properties. It has been shown to increase joint lubrication.~     Platelet-rich plasma contains growth factors that have been shown to promote tissue~     regeneration. The aim of this study is to determine whether injections of hyaluronic acid or~     platelet-rich plasma can be used reliably to decrease pain, restore function, and improve~     quality of life in patients suffering from glenohumeral OA. Patients will be randomized to~     receive either an injection of hyaluronic acid or an injection of platelet-rich plasma.~     Outcomes will be assessed via questionnaires for up to 24 weeks post-procedure.~   "
5574|NCT02984215|"~     Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare~     monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL)~     PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The~     investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM~     and PLL-PTLD.~   "
5575|NCT02984202|"~     The objectives of the clinical study are to implant five deaf patients (those with~     Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI;~     developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order~     to assess the safety, reliability, consistency of placement, and performance of the AMI~     device. The clinical trial is being performed at Hannover Medical School in Germany in~     collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The~     clinical trial is being managed by Hannover Clinical Trial Center in Germany.~   "
5576|NCT02984189|"~     Introduction: The inspiratory muscle training (IMT) has showed great benefits to the~     respiratory, autonomic system, and mainly to the improvement of physical performance in~     healthy subjects. The latter is related to the improvement of respiratory muscle strength,~     decreased of dyspnoea, peripheral fatigue and delay in activation of muscle metaboreflex~     during exercise. However, there is no consensus about the best training load to IMT, because~     the prescription has been done only using percentage of the maximal inspiratory pressure~     (MIP), and 60% of MIP has been the most used. Therefore, the IMT prescription protocol that~     takes into account the respiratory muscle strength and endurance can provide additional~     benefits to protocols commonly applied, once that respiratory muscle differs from the other~     muscles due to its greater muscle endurance. In the sense, the IMT using inspiratory~     critical pressure (PThC) comes up with an alternative, since the PThC calculation considers~     these characteristics. Objective:To evaluate the effect of the IMT, using PThC, on~     cardiovascular, respiratory, metabolic and autonomic responses in recreational cyclists and~     compare it to a IMT using 60% of MIP. Methods: Thirty men recreational cyclists (20-40~     years), will be randomized to placebo group (PG, n = 10), PThC group (PTHCG, n = 10) and 60%~     of MIP group (60G, n = 10), taking into account the age and functional aerobic capacity. All~     subjects will perform the following evaluations: cardiovascular autonomic tests [heart rate~     variability (HRV) and blood pressure variability (BPV) at rest and after active postural~     change], pulmonary function testing, respiratory muscle strength (RMS) test, cardiopulmonary~     exercise testing (CPET), incremental respiratory muscle endurance test (iRME) [maximum~     respiratory pressure sustained for 1 minute (PThMAX)] and constant respiratory loads test~     (95%, 100% and 105% of PThMAX), both using an linear inspiratory load resistor (PowerBreathe~     K5). The PThC will be obtained from the linear regression using the time(TLIM) of and load~     of each constant test (95%, 100% and 105% PThMAX). During evaluations, the ECG (BioAmp~     FE132), blood pressure (BP), using Finometer Pro (Finapress Medical Systems) and respiration~     (Marazza) signals will be acquired. The signals will be coupled by data acquisition and~     analysis device (Power Lab 8/35) and sampled at 1000 Hz. Moreover, the oxyhemoglobin,~     deoxyhemoglobin and total hemoglobin responses will be measured by near-infrared~     spectroscopy (NIRS) (Oxymon MKIII), sampled at 250Hz. The IMT will be performed for 11 weeks~     (3 times/week, 1-hour duration). The session will consist of 5-min warm-up (50% of the~     training load) and 3 sets of 15 minutes (breathing against 100% of the training load) with~     1-min interval between them. Heart rate and BP will be monitored in all training sessions.~     The RMS, iRME, respiratory constant load tests and CPET will be performed before and after~     the training, and in the 3rd and 7th week (for training load adjustment). The pulmonary~     function testing and the cardiovascular autonomic tests will be performed only before and~     after training. The data will be analyzed by specific statistical tests (parametric and~     nonparametric) according to the data distribution and their respective variances.~     Significance will be set at p<0.05. Expected results: It is expected that the training~     performed by PTHCG, when compared to training performed by 60G and PG, promotes: greater~     improvementin workload (Watts) and peak oxygen uptake (VO2peak); increasing in MIP and iRME;~     decreasing of dyspnoea and peripheral fatigue; delay in activation of muscle metaboreflex in~     the CPET and iRME; improvement incardiac parasympathetic autonomic modulation and reducing~     cardiac and peripheral sympathetic modulation. Moreover, it is expected that the results can~     provide information for a better understanding of the responses obtained by the PThC~     training in the different evaluated systems. In addition, these results will allow the use~     of this method by health professionals as a new assessment tool and IMT prescription.~   "
5577|NCT02984176|"~     Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and~     abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.~      The investigators objective is to evaluate the efficacy and safety of preoperative oral~     simethicone for bowel preparation in gynecological laparoscopies.~   "
5578|NCT02984163|"~     The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is~     to evaluate the relative benefit from, and implementation of an Alberta wide~     clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise~     (ACE) Program. The investigators hypothesize that the strategy will improve the physical~     well-being and QoL of survivors (on and off cancer treatment) while preventing the~     development of secondary cancers.~   "
5579|NCT02984150|"~     This study aim to investigate the influence of intragastrically infused fatty acid on the~     generalization of responses to reward within the food domain and between financial and~     sexual domains.~   "
5580|NCT02984124|"~     This multicenter RCT of 180 hospitalized patients and their family members evaluates an~     informed assent approach to discussing cardiopulmonary resuscitation, compared to usual~     care, in older seriously ill hospitalized patients with severe life-limiting illness or~     severe functional impairment.~   "
5581|NCT02984111|"~     The aim of this trail is to assess the safety and therapeutic effects of single EPO~     intervention in different times during coronary surgery in changes of inflammatory response.~   "
5582|NCT02984098|"~     The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood~     glucose concentration and to reducing of pain before painful procedures on healthy term~     neonate 72 hours aged.~   "
5583|NCT02984085|"~     Prospective open-label, uncontrolled clinical study to assess the safety and efficacy of~     autologous cultured epidermal grafts containing epidermal stem cells genetically modified~     with the aid of a gamma-retroviral vector carrying COL7A1 complementary DNA (cDNA) for~     restoration of the epidermis in patients with recessive dystrophic epidermolysis bullosa.~     The purpose of this study is to demonstrate the safety and efficacy after one or more~     treatments with genetically corrected cultured epidermal autograft (Hologene 7) in patients~     suffering of recessive dystrophic epidermolysis bullosa (RDEB) with COL7A1 mutation.~   "
5622|NCT02983578|"~     The goal of this clinical research study is to learn if AZD9150 given in combination with~     MEDI4736 (durvalumab) can help to control advanced pancreatic, lung, or colorectal cancer.~   "
5635|NCT02983409|"~     This is an observational study based on retrospectively collected data of ureter stone~     patients between 2011 and 2014. Aim of study is to determine radiologic findings of~     non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect~     ureter stone patients in emergency department (ED).~   "
5584|NCT02984072|"~     Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin~     cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range~     of other dermatological conditions. A major limitation of PDT is pain during irradiation. A~     lack of knowledge of the mechanism of PDT-induced pain has limited the development of~     effective approaches for prevention or relief of this adverse effect. The investigators have~     investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this~     in a clinical trial. This proposal describes the prospective randomised double blind,~     placebo controlled clinical trial that will be undertaken to investigate the use of topical~     menthol for PDT-induced pain relief in patients with actinic keratosis of the face and scalp~     who will be attending general dermatology and PDT outpatient clinics at Ninewells Hospital,~     Dundee.~   "
5585|NCT02984059|"~     To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)~     by examining factors such as disease type, activity and location, psychosocial factors, and~     genetics.~      The investigators hypothesize that by using patient pain and psychological assessments in~     addition to analysis of blood, stool and colonic biopsies, we can better characterize~     factors that predispose children and adolescents with IBD to have persistent and/or~     disproportionate abdominal pain.~   "
5586|NCT02984046|"~     Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.~      Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of~     epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7~     months. It could be an early predictive biomarker of the severity of acute bronchiolitis,~     and secondarily for the development of asthma.~      Two other markers of airway aggression seem to increase during acute bronchiolitis: serum~     SP-D protein and serum soluble receptor sRAGE.~   "
5587|NCT02984033|"~     The prospective trial is to describe the quality of life and psychological effects in~     patients with head and neck tumor receiving curative intent treatment~   "
5588|NCT02984020|"~     The objective of this study is to identify any problems and questions with respect to the~     safety and efficacy of Xeljanz during the post-marketing period as required by the~     regulation of MFDS.~   "
5589|NCT02984007|"~     Synopsis: In most countries, there is an increase in the number of parents who refuse some,~     most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a~     global phenomenon that needs to be measured and addressed. However, to this date, no~     effective strategy has been identified. Dr Gagneur have developed and validated a new~     approach to educate parents of newborns about vaccination, based on motivational~     interviewing (MI) techniques. MI is a method to elicit and strengthen motivation for change~     based on the person's own arguments for change that has been shown effective for the~     adoption of many preventive health behaviors. This approach has been validated for~     vaccination during a pilot study as well as in a provincial RCT in Quebec. Now that a proof~     of concept has been made in Quebec, the investigators will validate the approach in other~     contexts (e.g. English-speaking provinces and settings with different ways to deliver~     maternity care and childhood vaccines).~      Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward~     increases parents' intention to vaccinate their infant, reduces VH scores and increases~     infants' vaccine uptake in Quebec. This approach may be applicable across the country in~     order to tackle VH and thus improve infants' vaccine coverage (VC).~      Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate~     their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian~     context.~      Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will~     be randomized to receive the MI intervention (intervention group) or to receive an~     information flyer on vaccines (control group). MI intervention will be delivered by research~     assistant that will have first received a standardized training session on the content and~     techniques of MI. Parents will complete a self-administered questionnaire to measure~     knowledge and vaccination intention as well as VH before and after the intervention.~     Immunization data will be collected through an online questionnaire sent when the child will~     reach 3 months of age.~      Expected benefits: The strategy will be validated across different immunization programs~     from 5 Canadian provinces to take account of the differences in logistics and cultural~     contexts. Results from this study will provide to the provincial and national public health~     authorities an effective strategy to tackle VH.~   "
5590|NCT02983994|"~     The aim of the study is to evaluate the errors that may occur during inhalation of two~     devices in patients with asthma, as well as to study whether it relates to the degree of~     control of patient symptoms and the degree of compliance of medication symptoms. Finally, we~     also want to study the degree of patient satisfaction with each of the inhalers studied~   "
5591|NCT02983981|"~     A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of~     Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who~     are receiving biologic therapy for at least 24 weeks~   "
5592|NCT02983968|"~     Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in~     the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer~     deaths). This cancer is closely associated with the presence of chronic liver underlying~     disease and early diagnosis following a systematic surveillance of cirrhotic patients could~     improve disease-free survival in patients declaring HCC. However, the risk-benefit ratio of~     such monitoring is discussed. Nevertheless, it is recommended in patients with liver~     cirrhosis, from which the prevalence is estimated between 0.3% and 0.6% in the French~     population. This debate can lead to a failure to comply with recommendations and promote a~     large variability in the management of the surveillance of HCC in patients with cirrhosis in~     practice. Data acquisition regarding the current situation in France is required.~      The objective of this project is to use this database to document current practices~     concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective~     cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The~     primary analysis will focus on multivariate modelling of the deviation rate from the~     recommendations (advising the realisation of at least two echodoppler ultrasonographies~     yearly) with a competitive risk model, taking into account gender, social status, Charlson~     index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly~     number of visits to a hepatologist during follow-up. It is estimated that more than 86,000~     patients with a minimum follow-up of 3 years will be included in the analysis~   "
5593|NCT02983955|"~     The UPnRIDE Powered Wheelchair device is a product which changes people position from~     sitting to standing and standing to sitting. The product provides indoor and outdoor~     mobility.~      The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair~     as an outdoor and indoor mobility device by individuals with walking impairment.~   "
5594|NCT02983942|"~     Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high~     glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic~     diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous~     system lymphoma (PCNSL).~   "
22182|NCT02766829|"~     The study aimed to compare successful spinal needle placement between crossed leg sitting~     position and traditional sitting position in patients underwent urology surgery.~   "
5596|NCT02983916|"~     Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,~     affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,~     suggesting that adhesiolysis can play an important role in the management of such pain.~     Despite initial promising results regarding the effect of adhesiolysis on post-operative~     pain, implementation of the procedure has been challenging. The major problems associated~     with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high~     rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,~     diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI~     techniques, and with application of anti-adhesion barriers following adhesiolysis.~      In this study the investigators evaluate a new practice-based approach to the problem of~     chronic post-operative pain caused by adhesions. This practice-based approach includes use~     of a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI~     holds promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk~     for bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the~     investigators attempt to prevent adhesion reformation and improve long-term outcomes of~     adhesiolysis.~   "
5597|NCT02983903|"~     Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim~     is to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in~     patients at risk for lung cancer. Target population: Patients referred for bronchoscopy and~     lung biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients~     enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies~     for their lung lesion during bronchoscopy.~   "
5598|NCT02983890|"~     This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence,~     two-period crossover, cocktail study where a combination of cocktail-drugs is used to~     illustrate whether or not, or to what degree dicloxacillin affects the level of activity of~     the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious~     drug-drug interactions.~   "
5599|NCT02983877|"~     This study will test an adherence intervention (iTAB-CV) delivered via interactive text~     messaging which first targets behavioral intent and then adds cues/reminders and~     reinforcement to form the habit of taking antihypertensives in non-adherent individuals with~     BD. Thirty eight individuals with BD and HTN being treated with evidence-based~     antihypertensive agents and mood stabilizing or antipsychotic medications who are~     non-adherent with their HTN medicine will be enrolled.~      This study uses a prospective cohort design with participants serving as their own control.~     Investigators will test the iTAB-CV intervention quantitatively for feasibility and~     acceptability as well as for efficacy in increasing adherence to antihypertensives,~     decreasing systolic blood pressure, and increasing adherence to BD medication.~   "
5600|NCT02983864|"~     The objective of the proposed project is to conduct a randomized controlled trial (RCT)~     comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape~     myth acceptance) for men who receive a group alcohol intervention only to men who receive a~     group integrated alcohol and sexual assault intervention.~   "
5601|NCT02983851|"~     VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying~     the initial ventilation strategy for adult immunocompromised patients with acute respiratory~     failure.~   "
5602|NCT02983838|"~     Target of the research Based on change of Brain-derived neurotrophic factor and other~     pro-inflammatory cytokine along with symptom improvement following treatment, the~     investigators are trying to find the new treatment target molecule. The investigators will~     follow up the subjective and objective cognitive dysfunction with psychiatric symptom~     profiles and compare the neuroimaging related to these change.~   "
5603|NCT02983825|"~     Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs~     open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present,~     areas of the lung that are open for gas exchange do not match up with the areas of the lung~     that are receiving blood for gas exchange. This study measure the responsiveness of V/Q~     mismatch to changes in the amount (or level) of CPAP.~   "
5604|NCT02983812|"~     In this study, patients will be prospectively enrolled for data collection to design~     prediction models that integrate claims data (inpatient, outpatient, and pharmacy),~     electronic health record data (on clinical, social, and behavioral indicators), and~     patient-generated activity data. Patients will be randomized to use either a smartphone or a~     wearable activity tracking device to capture patient-generated health data.~   "
5605|NCT02983799|"~     This is a non-randomized, open-label study to assess olaparib tablets as a treatment for~     subjects with different homologous recombination deficiency (HRD) tumor status and with~     platinum-sensitive, relapsed, high-grade ovarian cancer. Subjects should have received at~     least 2 prior lines of platinum-based chemotherapy.~   "
5606|NCT02983786|"~     The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood~     flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow~     and metabolism monitor, by allowing physiologic and pharmacologic decisions based on~     real-time brain physiology, potentially will become an important tool for clinicians in~     their efforts to prevent additional brain tissue death in patients admitted with stroke,~     brain hemorrhage and traumatic brain injury.~   "
5607|NCT02983773|"~     This laboratory study will employ a repeated measures experimental design to examine the~     effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on~     alcohol craving and on behavioral economic measure of alcohol demand after exposure to~     alcohol cues, and on subsequent drinking in an alcohol choice task in which participants~     choose either to drink or receive monetary reinforcement for drinks not consume. The study~     will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana~     at least twice weekly.~   "
5623|NCT02983565|"~     Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some~     patients despite this oxygen, experience episodes of low oxygen levels (intermittent~     hypoxia) especially during sleep which may be harmful. In order to overcome this, the~     investigators have designed an auto-titrating oxygen system (called intelligent oxygen~     therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients~     already on oxygen. This study will investigate whether the intelligent oxygen therapy system~     can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.~   "
5608|NCT02983760|"~     Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes~     patient to the risk of potentially fatal recurrence. False positive testing exposes patients~     to potentially fatal unduly side effects of anticoagulants.~      Current diagnostic strategies rely on the sequential use of pretest clinical probability,~     Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE~     diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan.~     Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore~     requiring additional testing and more complex diagnostic algorithms. Main limitations of~     CTPA are its higher radiation dose and contraindications (renal failure).~      In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30%~     increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis~     of over-diagnosing and over-treating PE when using CTPA.~      V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has~     been reported to improve the diagnostic performances of the test, which could reduce the~     number of non-conclusive tests and allow simplified diagnostic algorithms.~      The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to~     the two usual approaches responding rightly to the two mains issues and combining the~     advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower~     radiation exposure, no contraindication).~      Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT~     rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in~     which diagnostic decision would be made on the basis of a standardized algorithm based on~     the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of~     diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously~     validated strategies, and to verify that the use of V/Q SPECT does not lead to~     over-diagnosis.~   "
5609|NCT02983747|"~     The purpose of this study is to evaluate the effectiveness of autologous platelet-rich~     plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will~     reduce the pain feeling and benefit for restore of the intervertebral disk.~   "
5610|NCT02983734|"~     The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment~     for Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous~     chronic health symptoms, including cognition and fatigue, which reduces their quality of~     life. Gulf War veterans are in urgent need of novel treatment plans to tackle elusive~     symptomatology of Gulf War Illness. By using the literature of previous studies, the~     investigators have chosen to investigate d-cycloserine as a possible candidate for treating~     GWI, specifically cognitive symptoms. DCS has been shown to reduce neuroinflammation,~     regulate glutamate levels, and improve synaptic functioning in key areas of the brain.~   "
5611|NCT02983721|"~     The purpose of this study was to assess and compare the feasibility, success and safety of~     Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic~     coronary angiography and coronary interventions, in terms of procedural time, access time,~     fluoroscopy time, procedural failure, , length of hospital stay in terms of days in~     hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections~     thrombosis of vessel, MACE, Stroke and others.~   "
5612|NCT02983708|"~     The current study describes a randomized, double-blind, cross-over study of intravenous~     G-CSF followed by infusion with autologous mobilized peripheral blood mononuclear cells~     (mPBMCs) in children with cerebral palsy (CP) to determine the safety and feasibility of the~     procedure, as well as the potential efficacy for improving neurological impairment.~   "
5613|NCT02983695|"~     This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis~     extract as an adjunct treatment in children with severe drug resistant epilepsy due to~     Dravet Syndrome. This is an open label intervention. Study duration is 20 weeks to primary~     analysis with continued follow-up until 64 weeks completed.~   "
5614|NCT02983682|"~     This is a study to evaluate the efficacy and safety of lidocaine in the management of~     chronic pain in children. All participants will receive lidocaine infusion and severity of~     pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks~     after infusion. Adverse events will be recorded.~   "
5615|NCT02983669|"~     The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria~     multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease~     (NAFLD).~   "
5616|NCT02983656|"~     The purpose of this study is to observe the occurrence of adverse events of live attenuated~     varicella vaccine.~   "
5617|NCT02983643|"~     Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes~     and disclose malnutrition risk effectively. The aims of the study are to assess prevalence~     of malnutrition in patients planned for SCT, to characterize changes in body composition~     (SMI, total adipose tissue and VAR) that occur in the peri transplantation phase, and to~     identify Waist Circumference (WC) cut off points associated with the metabolic syndrome~     (MetSyn) in patients with B and T cell Lymphoma.~   "
5618|NCT02983630|"~     Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as~     penicillin allergic is associated with increased health care costs, adverse effects and~     antibiotic resistance. The investigators will recruit participants from primary care~     practices labeled as penicillin allergic and offer allergy testing. The aim of this study is~     to develop a community, outpatient program for evaluation of penicillin allergy.~   "
5619|NCT02983617|"~     The objective of this study is to determine the preliminary efficacy and safety of the~     combination of GS-4059 and entospletinib with and without obinutuzumab in adults with~     relapsed or refractory chronic lymphocytic leukemia (CLL).~      The primary objective is evaluation of efficacy with the secondary objective evaluation of~     safety and evaluation of additional parameters of efficacy. The treatment period is~     adaptive, with a duration of active treatment up to two years and a total follow-up on study~     of 5 years for time-dependent outcome variables. The study has a 6 patient per arm safety~     run-in to evaluate safety prior to the enrollment of subsequent participants.~   "
5620|NCT02983604|"~     The primary objectives of the Phase 1b Dose Escalation part of this study are to~     characterize the safety and tolerability of GS-5829 in combination with exemestane or~     fulvestrant in women with advanced estrogen receptor positive Her2-negative (ER+/HER2-)~     breast cancer and to determine the maximum tolerated dose (MTD) (if not already determined)~     or the recommended dose for the Phase 2 part of this study.~      The primary objectives of the Randomized Phase 2 Dose Expansion portion of this study are to~     evaluate the efficacy of GS-5829 in combination with exemestane or fulvestrant compared to~     exemestane or fulvestrant alone in women with advanced ER+/HER2- breast cancer.~   "
5621|NCT02983591|"~     The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its~     use in the third stage of labor ineffective in reducing post partum blood loss as compared~     to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in~     reducing post partum hemorrhage.~   "
5625|NCT02983539|"~     The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and~     10% in children. Even though it is a rare cancer, it contributes to a significant loss of~     years of life in comparison with other types of cancer, due the fact that it affects~     children and young people. The diagnosis and treatment are difficult, considering the~     diversity and rarity of this disease. In addition, on average, more than 50% of patients~     with high-grade sarcoma present tumor relapse and distant recurrence is considered the main~     cause of death. The presence of Circulating Tumor Cells (CTCs) in the blood of patients with~     sarcoma may be an early marker of tumor invasion, because it is known that the CTCs~     circulate in the blood for months or years before the development of metastases. The CTCs~     can be used to monitor the response of the tumor to treatment, in order to match time, dose,~     and type of therapy.~      Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma,~     synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify~     CTCs. The investigators also have an intention to identify genes of resistance to treatment~     in these cells.~   "
5626|NCT02983526|"~     80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis~     were recruited from our waiting list. The patients were randomized to either CFP or Corail~     stem, both groups received Delta cup from Lima. Randomisation was done using envelopes.~     Patients could only participate with one hip. We are evaluating patients with different~     questionnaires, radiographs and RSA analysis.~   "
5627|NCT02983513|"~     Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period~     of stressful environment, which may negatively impact early brain development and subsequent~     neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in~     reducing stressful experiences early in life and in enhancing brain development and long~     term developmental outcomes.~   "
5628|NCT02983500|"~     Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.~   "
5629|NCT02983487|"~     Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a~     large number of adolescents and adults are no longer immunized against Bordetella pertussis,~     the agent of whooping cough and consequently may contract whooping cough. Furthermore, these~     populations represent a reservoir of the infectious agent from which the dissemination to~     non-immune infants is possible, causing severe illness, or even death, in this age group.~      Few studies have been carried out on whooping cough in developing countries (incidence,~     contaminator's age, etc.) and, specifically, none have assessed the duration of protection~     induced by the whole cell pertussis (wP) vaccine mainly presently used in these countries.~      However, data on the duration of vaccine induced protection are essential to determine i)~     the usefulness of vaccine boosters and ii) the target age group for these boosters.~      The aims of the present study are:~        -  To evaluate the proportion of confirmed pertussis cases in infants presenting whooping~          cough syndrome (WP1a)~        -  To evaluate the proportion of confirmed pertussis cases or healthy carriers among~          contact cases~        -  To determine origin of the infant's contamination (WP1b)~        -  To determine the duration of protection induced by the wP vaccines used in contact~          cases and the child population aged 3 to 15 yo (WP1b and WP2)~        -  To bring new scientific evidences documenting the potential need for initiating~          boosters (WP1b and WP2)~        -  To allow a comparison of the results with those obtained using the same methodology for~          the acellular pertussis vaccine and/or in other contexts. Potential implications for~          the use of pertussis vaccines in low and moderate income countries.~        -  To increase local capabilities by the transfer of materials and expertise that will~          make the diagnosis of pertussis possible in the centres of reference and strengthen a~          pertussis monitoring network in the implicated countries.~        -  To improve children's health through a better match of the vaccination schedule~          according to the reality of the situation.~   "
5630|NCT02983474|"~     The member of National Evidence-based Healthcare Collaborating Agency and the planning~     committee of Korean Association of hepato-biliary pancreatic Surgery established the~     protocol of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of~     American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and~     National Clinical Database (NCD) of Japan; demographics, preoperative information,~     laboratory values, operation finding, general occurrences, postoperative occurrences, and~     follow-up data to develop post cholecystectomy complication risk model.~      The 50 surgeons from 20 hospitals have decided to participated in the primary prospective~     study to apply KSQIP to cholecystectomy. The investigators developed web-based database~     system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill~     out the case report form. Finally, the investigators will provide a risk-adjusted surgical~     risk calculator and feedback system for reducing complication.~   "
5631|NCT02983461|"~     The investigators goal is to develop medical treatments for stress/mixed urinary~     incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and~     strength and to decrease muscle fatigue. The investigators believe that it will improve~     muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence~     related to pelvic floor dysfunction.~   "
5632|NCT02983448|"~     This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation~     (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients~     will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS,~     but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham~     or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve~     stimulation (TENS) device with electrodes attached to the tragus of the ear, which is~     innervated by auricular branch of the vagus nerve. Echocardiography will be performed after~     30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will~     be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).~   "
5633|NCT02983435|"~     The relevance of this study is to determine the efficacy of two osteopathic techniques -~     Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component~     of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few~     studies have investigated and compared the physiological responses of these techniques~     quantitatively, and no published study has compared their effects in low back pain subjects~     in terms of symptoms, postural balance and muscle activation. The main outcomes will be~     computed by electromyography measurement so that to assess the trunk neuromuscular~     activation pattern as well as by force platform parameters for determining of postural~     control. Clinical symptoms such as pain intensity, perception of disability and fear and~     avoidance will also be computed.~      This is the first study to compare these two osteopathic techniques using the main~     biological outcomes related to trunk neuromuscular function.~   "
5634|NCT02983422|"~     This study evaluates the effects of aminophylline on serum creatinine and urine volume of~     AKI Patient.Half of participants will receive aminophylline and furosemide in~     combination,while the other half will receive only furosemide.~   "
5706|NCT02982486|"~     The purpose of this study is to determine whether nivolumab plus ipilimumab are effective~     and safe in the treatment of sarcoma and endometrial carcinoma patients with somatic~     deficient MMR as a selection tool.~   "
5636|NCT02983396|"~     Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial~     infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary~     syndromes. The Mini RELF device is a hand held self applicable device intended to detect on~     an individual basis an elevation of the ST segment that is indicative for an acute coronary~     occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is~     self-applied on a daily basis by patients with coronary artery disease.~   "
5637|NCT02983383|"~     TAP block is the administration of local anesthetic agents into the anatomic neurofascial~     cavity between the internal oblique and transversus abdominis muscle in the antero-lateral~     region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12)~     and first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control.~     We aim to show the effect of TAP block administration on analgesic consumption after~     varicocelectomy operations, side effects linked to analgesic use and analgesic quality.~   "
5638|NCT02983370|"~     The objective of this study is to evaluate the usefulness of a cortical visual prosthesis~     based on intracortical microelectrodes to provide a limited but useful sense of vision to~     profoundly blind. This pilot study will provide important information on safety and efficacy~     for the development of an useful cortical visual neuroprosthesis for the blind.~   "
5639|NCT02983357|"~     The purpose of this study is to investigate if the use of autologous bone graft around the~     anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography~     scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.)~     better functional outcomes. Investigators hypothesize that a glenoid anchor peg component~     fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a~     lower incidence of glenoid loosening and that the absence of radiolucent lines will~     correlate with excellent shoulder function. Glenoid component loosening remains a major~     concern following total shoulder arthroplasty and is the man reason for failure. Despite~     positive findings in the investigators previous study (same population at a minimum of 2~     year post operative follow up), it is reasonable that loosening rates could increase with~     longer follow-up. This study will be a minimum of 7 year post operative follow up.~   "
5640|NCT02983344|"~     This study is performed to determine the efficacy of ultrasound-guided fascia iliaca~     compartment block during positioning for spinal anaesthesia in patient undergoing repair of~     proximal femur fracture surgery comparing with intravenous fentanyl.~   "
5641|NCT02983331|"~     In this study, the investigators aimed to overview patients with specific and non-specific~     complications who admitted to intensive care unit following endoscopic retrograde~     cholangiopancreatography and had fatal course in the facility~   "
5642|NCT02983318|"~     In a number of neuropsychiatric disorders such as depression, both brain inflammation and~     glutamate mediated excitotoxicity (cell death through over-activated stimulation) are~     suspected to play a key role. It is difficult, if not impossible, to determine the potential~     destructiveness of the inflammatory response seen in disease states by studying the brain's~     inflammatory cells (microglia) activity in isolation. The investigators are proposing to~     develop the means to concurrently study inflammatory response (i.e., microglial activity)~     and its potentially devastating consequence (i.e., glutamate excitotoxicity) across the~     entire brain in order to establish the importance of inflammation. In this study the~     investigators propose a phased clinical study whereby the early-phase involves the~     development of our capacity to study inflammation-mediated damage to brain cells, followed~     by a feasibility study in patients with clinical depression that tests whether concurrent~     inflammation and glutamate excess could be measured in key brain regions associated with a~     depressed mood state.~   "
5643|NCT02983305|"~     The goal of this study is to examine the ability of optical head‐mounted display technology~     to enlarge the visual field of patients with severe visual field loss due to retinal~     dystrophy and to improve mobility and patient‐reported outcomes.~   "
5644|NCT02983292|"~     The study is designed as a single center, post-market, non-randomized, open-label,~     observational clinical study with retrospective and prospective enrollment to evaluate the~     2-year post implantation survivorship of the PyroTITAN™ HRA device following the~     implementation of a new proof test to identify and eliminate devices with sub-standard~     mechanical integrity.~   "
5645|NCT02983279|"~     The purpose of this trial is to determine that sort term calorie restriction will affect~     tumor biology in biopsy proven breast, endometrial or prostate cancers, which will~     positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.~   "
5646|NCT02983266|"~     The purpose of this research device study is to learn more about the autonomic nervous~     system. This system uses nerves to send information from the brain to the rest of the body~     by electrical signaling and has two divisions, the sympathetic and the parasympathetic~     branches. It has been thought that electrical stimulation devices could be used to restore~     balance to the nervous system. Because most of the imbalance seems to happen due to too much~     sympathetic activity, the investigator plans to focus on the parasympathetic branch.~     Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which~     is the main communicator of the parasympathetic branch. The study will examine whether the~     investigator can decrease sympathetic activity and chronic inflammation by increasing~     parasympathetic activity. This is a device study that will examine the use of non-invasive~     vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in~     persons with Spinal Cord Injury and Non-Disabled Controls.~   "
5647|NCT02983253|"~     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is~     an inherited multisystemic disorder. Literature suggests that HHT is often associated with~     higher frequency of infectious diseases.~      The purpose of this study is to evaluate a variety of immunologic parameters in the blood~     serum of HHT patients in comparison to probands.~   "
5648|NCT02983240|"~     The purpose of this study is to explore a new method to stop preterm uterine contractions~     using an electrical device. The device, an electrical pacemaker for the uterus, has been~     approved by the Food and Drug Administration (FDA) for clinical research in pregnant women.~     The purpose of this study is to evaluate the feasibility and safety of the device. The~     investigators hypothesize that human preterm uterine contractions can be safely and~     objectively inhibited with a weak electrical current provided by an electrical inhibition~     (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI~     exposure.~   "
5649|NCT02983227|"~     This is a Phase II, multicenter, open-label extension study to evaluate the long-term safety~     and efficacy of GDC-0853 in participants with moderate to severe active RA who have~     completed 12 weeks of study treatment in Study GA29350 (NCT02833350). Eligible participants~     from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily~     (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8~     weeks.~   "
5650|NCT02983214|"~     Investigation of the clinical efficacy and safety of dual antiplatelet therapy with~     clopidogrel and cilostazol versus clopidogrel alone in preventing ischemic vascular events~     in patients with type 2 diabetes and symptomatic peripheral arterial disease.~   "
5651|NCT02983201|"~     The objective of this trial is to further confirm and assess the efficacy of filiform needle~     therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack~     needle therapy could further enhance the clinical efficacy and pain healing effect of the~     filiform needle therapy.~   "
5652|NCT02983188|"~     One double-blind, randomized, placebo-controlled trial is designed to examine whether~     berberine added to current antipsychotic drugs could produce significantly greater efficacy~     in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective,~     120 patients with schizophrenia spectrum disorders (SSD) who have developed metabolic~     syndrome will be recruited and randomly assigned to receive additional treatment with~     placebo (n = 60) or berberine (n = 60, 1.2 g/day, 0.4 g, t.i.d.) for 12 weeks. The primary~     outcome is weight gain; other outcomes include body mass index (BMI), waist circumference,~     blood pressure, triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and~     low-density lipoprotein (LDL), fasting glucose, insulin, and insulin resistant index.~   "
5653|NCT02983175|"~     Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of~     gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during~     anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol~     qualified full stomach whatever the patient and the preoperative fasting period are. This~     protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or~     rocuronium). However, these neuromuscular blocking agents are ten times more at allergic~     risk than others. Ultrasound assessment of gastric content before rapid sequence induction~     of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside~     technique. Furthermore, the correlations between gastric volume and risk of a full stomach~     and also between the cross-section antral area (CSA) and the risk of a full stomach have~     been validated on several patient cohorts. We formulate the hypothesis that the achievement~     of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify~     full stomach patients who actually justify rapid sequence induction of anesthesia with~     exposure to fast-acting neuromuscular blocking agents that implies.~      Primary endpoint is to determine te percentage of patients who have a gastric content before~     appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and~     anaphylactic shock. Another secondary endpoint is to determine the percentage of patient~     with gastric content with the antral grading system (Perlas method) and to evaluate the~     concordance between this methode and the cross-section antral area.~   "
5654|NCT02983162|"~     Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a~     significant association between the weighted genetic risk score and Dupuytren disease~     recurrence. However, a significant dose-response relation was not found. This might be~     caused by underestimating the recurrence rate, due to the retrospective nature of~     determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF~     participants, to see whether they suffered from recurrent disease.~      Objective: We aim to determine whether the wGRS is associated with recurrent DD.~      Study design: An observational study, in which the participants of the GODDAF study are~     followed up.~      Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were~     previously included in another study on the genetic basis of Dupuytren disease.~      Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter~     is the presence of recurrent Dupuytren disease.~   "
5655|NCT02983149|"~     Patients undergoing thoracic surgery require selective ventilation of one lung, which allows~     surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung~     ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or~     the placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of~     which are in routine clinical use at University Health Network.~      Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design~     and two balloons, one of which is designed to fall into each of the right and left sides, it~     may require less repositioning. Initial clinical experience with the EZ Blocker suggests~     that it may be less likely than other blockers to become malpositioned during surgery.~      This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker~     at this institution, and to double-lumen tubes, the most commonly used devices to provide~     lung isolation, with respect to intra-operative malpositioning and the speed of lung~     separation and efficacy of lung collapse during thoracic surgery.~      Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or~     left-sided DLT, immediately prior to induction of anesthesia.~      The primary end points of time to lung isolation and number of required repositioning~     maneuvers.~   "
5656|NCT02983136|"~     The aim of this integrated Knowledge Translation (iKT) study is to develop and test a~     multifaceted implementation intervention for feasibility, acceptability and effectiveness.~     The intervention will be tailored to fit the context of the operating room (OR), to promote~     OR team members' use of aseptic techniques during the care of frail persons undergoing acute~     fracture surgery of the hip.~      Through the use of an iKT approach, the investigators hypothesise that building on~     leadership support, partnership between researchers, managers/clinical leaders and~     healthcare professionals, a solid foundation for the sustained implementation of patient~     safety innovations can be created.~   "
5657|NCT02983123|"~     This study evaluates if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac~     troponin T (hs-cTnT) is safe and effective in patients with a lower pretest probability of~     an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1-~     and 4/6-hours, where absolute changes in the values will decide whether the patient need~     hospitalization or not. Can the time interval to the second troponin test be reduced by~     using an 1-hour high-sensitivity assay?~   "
5658|NCT02983110|"~     The purpose of this research study is to better understand how sex hormone therapy that is~     used to treat women for menopausal symptoms, men with low testosterone, or as hormone~     therapy for transgender women, affects a class of medications called NRTIs (nucleoside~     reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most~     commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug~     Truvada and also included in the combination products Atripla, Complera, and Stribild. The~     medication's ability to work effectively may be altered when someone is also taking sex~     hormone therapy.~      In order to determine this effect, samples will be collected from some parts of the body~     where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV~     virus and sex hormones that are present. The samples that will be looked at in this study~     include blood, cells from the vagina, semen, and tissue biopsies from the female genital~     tract and rectum.~   "
5659|NCT02983097|"~     The goal of this study is to evaluate efficacy and safety of the combination of~     lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment,~     called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy~     consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based~     chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated,~     carboplatinum.~   "
5660|NCT02983084|"~     The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi~     archwires and a recently marketed multiforce version of the same material for the initial~     alignment and leveling of dental arches, as well as the expression of EARR in adult~     orthodontic patients.~   "
5661|NCT02983071|"~     This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in~     combination with fulvestrant in patients with hormone receptor-positive, HER2-negative~     metastatic breast cancer.~      The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and~     expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment~     Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose~     with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients~     will be enrolled in the study.~   "
5662|NCT02983058|"~     The primary goal of the present study is to evaluate the utility of mGluR5 binding as~     measured by PET as biomarker of the CNTNAP2 mutation and related mTOR kinase pathway~     dysregulation.~   "
5663|NCT02983045|"~     This study is to determine first, the recommended Phase 2 dose of NKTR-214 when administered~     in combination with nivolumab, and then, the clinical benefit, safety, and tolerability of~     combining NKTR-214 with nivolumab in select patients with melanoma, renal cell carcinoma or~     non-small cell lung cancer. Both drugs target the immune system and may act synergistically~     to promote anti-cancer effects.~   "
5664|NCT02983032|"~     Background: between 50-74% of dementia carers report some sleep disturbance. However,~     relatively few studies have looked at psychological treatment for insomnia in this group.~     Dementia carers may be particularly at risk for suffering negative consequences from the~     impact of sleep loss on top of the stress of their carer role. Researchers have found that~     Brief Behavioural Treatment for Insomnia (BBTI) can be effective for improving symptoms of~     insomnia in older adults. BBTI focusses on sleep-related behaviour such as napping and when~     a person gets up and goes to bed.~      Aims: this study aims to explore whether delivering group-based, Brief Behavioural Treatment~     for Insomnia (BBTI) to family carers of people with dementia is feasible, given that, to~     date, this has not yet been explored.~      Who is eligible?: carers with insomnia who care for a family member with dementia and live~     with them at home are eligible for inclusion in this study.~      What is involved for participants?: taking part will involve an initial telephone discussion~     with a researcher to check suitability. Participants will then meet the researcher for~     assessment. Assessment includes a sleep interview and completing some questionnaires.~     Participants will then be required to attend 3 group sessions of BBTI across the space of 4~     weeks. After attending the BBTI group, participants will be asked to fill in some of the~     same questionnaires that they filled in during assessment and again 4 weeks later.~     Participants will also be invited to take part in a focus group to give feedback about the~     treatment and their overall experience of being in the study.~   "
5665|NCT02983019|"~     This study evaluates the statistics of influenza and acute respiratory viral infections~     (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:~     disease severity and bacterial exacerbations; patients demography; treatment duration and~     timelines; safety; quality of treatment) in routine clinical practice with focus on drug~     therapy and usage of interferons' inducers.~   "
5666|NCT02983006|"~     The purpose of this study is to evaluate the safety profile, tolerability, and~     immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with~     nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.~   "
5667|NCT02982993|"~     This study provides Hepatitis C virus screening to the members of the World Trade Center~     Health Program followed at the Icahn School of Medicine at Mount Sinai born during~     1945-1965, and linkage to care for those found infected. The study will also determine if~     exposure to human remains, blood and/or bodily fluids during the World Trade Center Health~     Program activities are associated with Hepatitis C virus infection. These findings would be~     relevant to the larger United States population, especially to persons born during 1945-1965~     who are at high risk of Hepatitis C virus infection.~   "
5668|NCT02982980|"~     The presence of pain, reduced range of motion and decrease of muscle strength of the upper~     limb in the early postoperative period are some of the major deficiencies of the breast~     cancer patients.~      The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain,~     perimetry of the upper limbs and applied questionnaires of the upper lim function and~     quality of life, in patients after surgical treatment of breast cancer in different~     postoperative periods and different groups following rehabilitation: traditional~     postoperatively exercise to perform at home versus traditional exercises associated with~     weekly physiotherapy sessions to strength training for shoulder movements.~   "
5777|NCT02981550|"~     The purpose of this feasibility study is to test a device which analyzes breath and may~     allow doctors and health professionals to immediately determine if an ill patient has a~     specific type of bacterial infection. This will allow a health professional to provide~     immediate targeted antibiotics to properly start treatment without delay.~   "
5669|NCT02982967|"~     The purpose of present study was to investigate the effect of 10 weeks of recreational~     physical activity program on the irisin levels, progenitor endothelial cells and~     cardiometabolic profile in healthy children. Also, we investigated the correlation between~     this markers with anthropometric data, body composition, cardiac autonomic balance and~     physical fitness parameters. We evaluated eighty children aged 6 to 14 participated in the~     recreational physical activity program by 10 weeks (Duration: 60 minutes; Intensity: 65%-85%~     heart rate reserve; Frequency: 4 sessions/week). All parameters were evaluated before and~     after this approach.~   "
5670|NCT02982954|"~     To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with~     previously untreated advanced or metastatic Renal Cell Cancer.~   "
5671|NCT02982941|"~     This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to~     characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor~     activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses~     (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or~     refractory malignant solid tumors.~   "
5672|NCT02982928|"~     The current study is designed to measure and evaluate the pharmacokinetic profiling of~     acetaminophen in the young obese patient population.~   "
5673|NCT02982915|"~     This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety~     and efficacy of LMCSs for improving vaccine immune response.~   "
5674|NCT02982902|"~     The purpose of this study is to determine if a specific type of cell-based immunotherapy,~     using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to~     treat infections by CMV.~      Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the~     blood of a donor and selecting the T-cells that can respond against a specific infectious~     entity. These selected T-cells are then infused to the patient, to try to give the immune~     system the ability to fight the infection. Adoptive T-cell therapy is experimental because~     it is not approved by the Food and Drug Administration (FDA).~   "
5675|NCT02982889|"~     This study is designed to assess and characterize the safety and tolerability profile of~     LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride~     when infiltrated into a defined area of the medial calf, and to characterize bupivacaine~     plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A~     or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK~     parameters of each product.~   "
5676|NCT02982876|"~     Silicone stents are used as standard of care to identify which patients with excessive~     dynamic airway collapse will benefit from a definitive surgical treatment. However, the~     specific way in which these stents are effective has not been tested. The purpose of this~     research study is to determine the effectiveness of the silicone stent when used in the~     airways of patients with severe symptomatic excessive dynamic airway collapse compared to~     patients with severe symptomatic excessive dynamic airway collapse that do not receive~     silicone stent.~   "
5677|NCT02982863|"~     1. To understand the treatment patterns of OACs and baseline patient characteristics of~          Japanese Non-Valvular Atrial Fibrillation (NVAF) patients~        2. To determine whether warfarin and dabigatran new user group can be balanced using~          propensity score matching using pre-specified baseline covariates.~        3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in~          database~   "
5678|NCT02982850|"~     The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population~     and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of~     all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of~     ischemic stroke per year. Patients with valvular AF are known to have a higher incidence of~     stroke than patients with nonvalvular AF. However, the relevant data are insufficient as~     large randomized studies comparing NOAC treatment with warfarin, a conventional treatment,~     did not include many patients with moderate and severe valvular AF.~      Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic~     resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without~     stroke symptoms. According to a brain MRI follow-up study, the incidence of silent cerebral~     infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects~     reporting to have experienced symptoms. This means that the incidence of silent cerebral~     infarct is approximately 9 times that of symptomatic stroke. In addition, patients with a~     history of silent cerebral infarct are known to be approximately twice more likely to~     experience stroke in the future than those without a history of silent. Brain microbleed is~     easily detected by brain MRI and is a well-known independent predictor of intraparenchymal~     hemorrhage and silent cerebral infarct. The prevention of stroke by the study drug can be~     indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed~     on brain MRI. Investigators tried to compare effect of dabigatran with conventional~     treatment in terms of prevention of stroke by comparing incidences of silent cerebral~     infarct and brain microbleed and symptomatic stroke using brain MRI.~   "
5679|NCT02982837|"~     To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who~     have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200~     for last 3-6 month) with NA's can result in increased rate of HBV infection eradication~     (HbsAg is undetectable by serological blood testing with or without seroconversion to HBs~     antibody).~   "
5680|NCT02982824|"~     Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug~     resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams~     University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs~     AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at~     base line and after 6 months of treatment.~   "
5681|NCT02982811|"~     The purpose of this study is to determine whether additional therapy with i-ACT system is~     effective in the training of functional skills in persons with central neurological diseases~     (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).~   "
5682|NCT02982798|"~     A randomized, open-label, single dose, crossover study to compare the pharmacokinetic~     characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in~     healthy male volunteers~   "
5778|NCT02981537|"~     The purpose of this study is to find a novel method for placing endobronchial blockers~     without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic~     surgery.~   "
5683|NCT02982785|"~     The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards~     can predict the future course (post hospitalisation) of recovery of patients undergoing KA.~     The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor~     prognosis; 10=best prognosis).~      To identify candidate prognostic factors, the therapist are asked to qualify their prognosis~     narratively, by listing at least 3-5 factors that they consider important for their~     projected prognosis score. There will be no maximum number of factors the physiotherapist~     can list.~   "
5684|NCT02982772|"~     The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and~     Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper~     these excessive levels will enhance the efficacy of the intervention. To test researchers~     proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a~     double-blind randomized clinical trial intent-to-treat design, comparing a standard~     well-validated brief smoking intervention, that following national guidelines + nicotine~     replacement therapy (NRT), versus the tailored one (brief smoking intervention +~     personalized doses of nicotine replacement therapy). The primary outcome for this study will~     be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and~     verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.~   "
5685|NCT02982759|"~     Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly~     high. This study proposes to implement a comprehensive, multi-level intervention among~     children, families, the schools, and the community to combat this problem. The two year~     intervention will be measured by examining changes in children's body mass index.~   "
5686|NCT02982746|"~     At all of the follow-ups, including the worst period (between four and ten weeks), the~     intervention group reported higher scores than the control group, suggesting in this RCT~     that adopting the person-centred-care concept was a promising way to improve function and~     wellbeing in patients with HNC.~   "
5687|NCT02982733|"~     In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug.~     Recently, ABS has been shown to produce local hemostasis by implementing topically after~     major arterial vessel injury. Reducing the compression time during patent hemostasis by~     facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned~     a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper~     in adjunct to short-time compression, compared to either short-time compression with~     conventional sterile gauzes or with a TR band after transradial diagnostic procedures.~   "
5688|NCT02982720|"~     This is an open-label, single-arm, multicenter Phase II safety and efficacy study of~     combination therapy with pembrolizumab and PEG-Intron (Peginterferon alpha-2b) in patients~     with advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline~     chemotherapy. PEG-Intron will be administered to patients as a 3ug/kg (subject to possible~     dose modification) subcutaneous injection weekly, while pembrolizumab will be administered~     as a 200mg IV infusion once every three weeks, starting on week 4 (at the same time as the~     4th dose of PEG-Intron). This trial design provides an initial window (3 weeks) to evaluate~     the effect of PEG-Intron alone on tumor microenvironment in comparison to that of prior~     therapy: a biopsy prior to treatment will be collected, followed by a, repeat tumor biopsies~     collected while the patients receive PEG-Intron. Tumor tissue will be collected and analyzed~     as described in the next paragraph.~   "
5689|NCT02982707|"~     A single oral dose of BMS-986177administered to subjects of mild hepatic impairment,~     moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics,~     safety, and tolerability in these subjects~   "
5690|NCT02982694|"~     The primary objective of this study is to determine the anti-tumor activity, as measured by~     overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with~     chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an~     international, open-label single arm (non-randomized), one-stage phase II trial.~   "
5691|NCT02982681|"~     Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be~     effective in promoting reduction in probing depth, gain in clinical attachment, and defect~     fill in intrabony periodontal defects. The individual role played by bioactive glass putty~     in combination with PRF is yet to be elucidated.~      AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and~     Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony~     defects in humans.~      Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and~     Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on~     other side. The primary outcomes of the study included changes in probing depth, attachment~     level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3,~     6, and 9 months. Radiographic assessment was done using standardized intra oral periapical~     radiographs. Comparisions were made within each group between baseline, 3 months, 6 months~     and 9 months using the ANOVA test followed by Bonferroni test.~   "
5692|NCT02982668|"~     The purpose of this academic lead study is to explore the ideal nutritional support strategy~     for patient with acute severe stroke.~   "
5693|NCT02982655|"~     The purpose of this academic lead study is to explore ideal blood pressure targets and~     optimum individualized anti-hypertension strategies in acute severe stroke.~   "
5694|NCT02982642|"~     This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled,~     parallel trial which will be carried out in 15 centers around China. The study population~     includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in~     both gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3~     times per day) or placebo for a 52-weeks double-blind treatment period. The primary outcome~     measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition~     Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes~     from baseline in the Mini-Mental State Examination (MMSE), Delayed Story Recall test (DSR),~     Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI~     patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse~     reaction during the entire treatment period. Statistical analysis will be conducted~     according to per-protocol population and intend-to-treat population and the safety will be~     analyzed in safety set.~   "
30200|NCT02661802|"~     The purpose of this study was to evaluate the acute effects of oxygen supplementation during~     a submaximal exercise test in patients with Eisenmenger's Syndrome.~   "
5695|NCT02982629|"~     1. To design and develop a prospective, randomized pilot study utilizing information from~          electronic medical records to address follow-up adherence and reduce the gap between~          recommended and actual follow-up adherence in patients with glaucoma.~        2. To evaluate the impact of a telephone-based intervention on follow-up adherence in~          patients with glaucoma using a randomly assigned comparison with usual care.~   "
5696|NCT02982616|"~     The purpose of this study is to test whether intragastrically infused fatty acid will~     interact with positive emotion induction and if this effect is mediated by gut hormones.~   "
5697|NCT02982603|"~     This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel~     controlled phase VI trial being carried out in 20 centers around China. The study population~     includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in~     both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2~     times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)~     (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo~     identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a~     52-weeks double-blind treatment period. The primary outcome measure is change from baseline~     in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of~     conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental~     State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative~     Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is~     being assessed by observing side effects and adverse reaction during the entire treatment~     period. Statistical analysis will be conducted according to per-protocol population and~     intend-to-treat population and the safety will be analyzed in safety set.~   "
5698|NCT02982590|"~     The purpose of this study is to compare the novel oral anticoagulant apixaban with the~     standard therapy of warfarin on the size reduction or resolution of left ventricular~     thrombus over 6 months.~   "
5699|NCT02982577|"~     The purpose of this study is to evaluate the effectiveness of a spray the basis of~     pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary~     Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto~     (HCFMRP-USP), and its impact on quality of life.~   "
5700|NCT02982564|"~     The purpose of this study is to evaluate the effect of two exercise programs: 1) one program~     will be at low intensity; 2) the other program will be at moderate intensity. One hundred~     forty two women who are breast cancer survivors will be recruited. Participants will be~     educated on a home exercise program to be performed at either low or moderate intensity,~     according to group assignment. Evaluations to participants will consist of function and~     quality of life.~   "
5701|NCT02982551|"~     This study evaluates the effects of changing insulin levels on brain activity. Participants~     will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions,~     then during an insulin infusion.~   "
5702|NCT02982538|"~     This randomized study examines how prolonged exposure (PE) therapy, an evidence-based~     treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and~     implemented in the Army. The study compares two PE training models: Standard PE training,~     comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop~     plus expert case consultation. In addition, patients with posttraumatic stress symptoms~     receiving psychotherapy from participating providers will be invited to participate. After~     completing PE training, use of PE components with patients reporting PTS symptoms and~     clinical outcomes of these participating patients will be monitored for up to 18 months.~   "
5703|NCT02982525|"~     A significant proportion of the United Kingdom population have inadequate levels of vitamin~     D in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and~     maintenance of healthy bones through increasing dietary calcium absorption within the body.~     A low vitamin D status has also been associated with other diseases such as osteoporosis,~     cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin~     is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight~     is limited, then a dietary supply of vitamin D becomes essential.~      However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are~     oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the~     investigators found that certain shellfish, especially mussels, contain significant amounts~     of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has~     already been shown to improve vitamin D status in humans. Whether consumption of mussels~     improves vitamin D status is unknown.~      In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions~     of mussels per week for 12 weeks increases vitamin D status in healthy people.~   "
5704|NCT02982512|"~     The implantation of a deep brain stimulator (DBS) is an established option to improve the~     symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical~     therapy. Most centers perform this surgery using a technique that involves microelectrode~     recording (MER) of neuronal activity for localization of the target nucleus,~     microstimulation of identified targets, and neurological intraoperative testing in a~     cooperative patient.~      Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at~     subcortical areas of the brain without involving GABA receptors. It provides excellent~     sedation without respiratory depression; also, it has an analgesic component and a~     predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.~     The possible effect of dexmedetomidine in the PD symptoms is still unclear.~   "
5705|NCT02982499|"~     The participant is being asked to be a subject in this research study because the~     participant may have a disorder that can cause optic nerve damage and impairment of his/her~     visual function which is called optic neuropathies (ON). Optic neuropathy refers to damage~     to the optic nerve (a cable connecting the eyes and the brain to transmit the visual~     signals) due to any cause.In this study, the investigator is using magnetic resonance~     imaging (MRI) and ophthalmic measures such as optic coherent tomography(OCT), which are~     non-invasive imaging tests to measure the changes in eye globe shape ,the flow of blood and~     brain fluid. It is hoped that this study will provide new knowledge that may allow the~     investigator to better understand the cause of symptoms associated with optic neuropathy and~     ways to better monitor what is happening.~   "
5707|NCT02982473|"~     The Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics~     and Interventions (RACE-IT) represents a mono-centric registry of patients being~     hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)~     and sudden cardiac death (SCD).~      Detailed findings of patients' clinical outcome regarding mortality and co-morbidities~     related to the presence of invasive diagnostics or therapies including coronary angiography,~     percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter~     ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will~     be documented. Patients will be included when being hospitalized from the year 2004 until~     today.~   "
5708|NCT02982460|"~     Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder~     pain with prevalence estimated to be as high as 14% in general working-age population. RCT~     is a broad entity, including a vast variety of diagnosis such as shoulder impingement~     syndrome, RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is~     characterised by persistent pain and/or disability and/or recurrent episodes. It often leads~     to decrease function, lower health-related quality of life, poor sleep quality, work~     absenteeism, as well as patient's suffering. Previous studies support exercise as an~     adequate treatment in RCT. Nevertheless, our knowledge, there is no studies evaluating the~     effects of isoinertial training in RCT. Therefore, the aim of this study will be to pilot~     the methods proposed to conduct a substantive study to evaluate the efficacy of isoinertial~     training plus eccentric training versus eccentric training alone on improving pain and~     function in RCT. The objectives were to evaluate: (i) The process of recruitment and~     retention rates; (ii) Willingness of participants to be randomised; (iii) The extent of~     contamination between groups; (iv) Participant adherence with treatment. The secondary aim~     will be to analyse the effects of isoinertial training plus eccentric training versus~     eccentric training alone on rotator cuff strength, scapular muscle activity, and scapular~     muscle endurance in people with RCT.~   "
5709|NCT02982447|"~     It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for~     use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal~     method.comparison of detection and miss rates of BLI group Versus conventional White Light~     Colonoscopy.~   "
5710|NCT02982434|"~     The aim of this prospective randomized double-blind study was to compare the efficacy of new~     pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for~     preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial~     fibrillation undergoing coronary artery bypass grafting.~   "
5711|NCT02982421|"~     Art Therapy is a health profession in which art making is utilized as a means of expression~     and communication within a therapeutic and supportive relationship [1]. Art therapy has been~     shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms~     which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide~     an initial understanding of the mechanisms through which art therapy facilitates symptom~     reduction [8]. Breast cancer patients have reported that art therapy provided them with~     access to emotional material otherwise inaccessible [9]. The goal of this study is to~     examine the effect of art making within a therapeutic framework on emotional awareness and~     acceptance.~   "
5712|NCT02982408|"~     Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk~     factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of~     calories, and/or a low physical activity level, associated with increased fat storage and~     altered lipid metabolism plays a central role in the pathogenesis of insulin resistance and~     T2D. Using state-of-the-art large-scale integrative physiology studies combined with basic~     studies of adipose and muscle tissue stem cell functions, the investigators aim to determine~     if LBW individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial~     hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate~     overfeeding. The investigators will subsequently examine if exercise training can revert~     and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth~     weight differential manner.~   "
5713|NCT02982395|"~     The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of~     patients with recurrent Ta and T1 who experienced treatment failure with at least one prior~     BCG intravesical treatment.~   "
5714|NCT02982382|"~     The burden of low back pain more than doubled in the last 20 years, probably caused by~     biopsychosocial factors. Some noninvasive treatments have been applied in individuals with~     chronic nonspecific low back pain as spinal manipulation and pain education. However, it is~     not already clear the neurophysiological effects of these treatments.The purpose of this~     research is to verify the effects of the technique of spinal manipulation and pain education~     in individuals with chronic low back pain~   "
5715|NCT02982369|"~     This study aims to investigate the effects of vertebral manipulation and pain education on~     subjects with neck pain. For this purpose, 128 subjects who present chronic neck pain will~     be selected and allocated randomly into 2 groups: the vertebral manipulation group and the~     pain education group.~   "
5716|NCT02982356|"~     The risk of abnormal chromosome and structure is much higher in twins than in singletons,~     and traditional early pregnancy screening strategy for single pregnancy is not suitable for~     twins. Based on our management experience of fetal medicine at twin pregnancy, and~     multi-center cooperation, the study will carry out the following clinical studies:~        1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for~          twin pregnancy.~        2. fetal chromosomal abnormalities~   "
5749|NCT02981914|"~     This pilot study has been designed to investigate the safety of pembrolizumab treatment for~     disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be~     administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with~     relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following~     alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up~     to 24 months, provided that neither disease progression, nor development of a dose-limiting~     toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout~     the trial and graded in severity according to the guidelines outlined in the NCI Common~     Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in~     accordance with Good Clinical Practices.~   "
5717|NCT02982343|"~     Charcot Marie Tooth (CMT) is the most common inherited neuropathy. It affects the nerves of~     the hands and feet first, slowly progressing towards the centre of the body. It causes~     varying degrees of weakness and reduced feeling, usually affecting the feet and ankles~     first. High incidence of falls and knock on effects in quality of life are common. This is a~     lifelong condition which, though not life limiting, does not have a cure. Research into the~     effect of balance rehabilitation in people with CMT has been limited to traditional~     exercises, which do not address the complex nature of balance impairments in this condition.~     Multi-sensory rehabilitation has proved beneficial in improving balance in people with~     sensory neuropathy. Research shows that strengthening trunk muscles can improve balance in~     older people. Trunk and muscles close to it are largely unaffected in people with CMT,~     therefore these muscles could be strengthened in these patients. This study proposes to~     assess the feasibility of multi-sensory balance training, strength training with a focus on~     the trunk and muscles close to the trunk, and falls management education. This comprehensive~     approach is reflective of a clinical physiotherapy programme. Though a life-long condition,~     many people with CMT lead full lives. A home based programme is proposed to so that patients~     can fit it into their lives without having to travel for treatment. Therapists will use~     self-management principles within treatment. Measurements will be taken prior to and~     following treatment including physical measures, questionnaires and interviews. The~     physiotherapy interventions will be taught home and data collection will be at the National~     Hospital for Neurology and Neurosurgery, University College London Hospitals (UCLH).~   "
5718|NCT02982330|"~     Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to~     sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is~     known to reduce post-meal glucose excursions but it is unknown whether lowering the~     carbohydrate at breakfast only will impact subsequent post meal glucose excursions~     throughout the day. The aim of this study is to examine, under free living conditions and~     using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower~     daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current~     diabetes guidelines).~   "
5719|NCT02982317|"~     A novel automated ultrasound software system has been developed which identifies for the~     practitioner the intervertebral spaces in the lumbar area. This study aims to investigate~     whether this new technology has a greater accuracy of identifying intervertebral spaces that~     manual palpation.~   "
5720|NCT02982304|"~     Dystonia is increasingly being considered as a multi-nodal network disorder involving both~     basal ganglia and cerebellar dysfunction. The aim of this study is to determine if~     Multi-Target Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients~     who are receiving inadequate therapy from GPi DBS.~   "
5721|NCT02982291|"~     Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly~     population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain,~     as well as by weakness precipitated by walking and prolonged standing. Self-management~     options include physical therapy, which includes exercise as a core component for improving~     the flexibility and mobility of the spine and hips. A Williams flexion protocol has~     historically been used to treat low-back pain following degenerative changes to the~     posterior elements of the lumbar spine. However, few studies have been done to validate the~     efficacy of this protocol. A more individualized treatment protocol may be more efficacious.~     Patients in this study will be randomized to receive either the conservative physical~     therapy protocol or the individualized regimen. Outcomes will be assessed using validated~     questionnaires and physical function tests.~   "
5722|NCT02982278|"~     This research project will evaluate the relationship between cardiovascular risk factors,~     degrees of physical and mental activity prior to the stroke, brain tissue integrity,~     post-stroke community participation and neurological recovery after the stroke.~     Investigators will recruit and study a biracial cohort, gaining insight into the possible~     mechanisms that explain why the adverse risk profile, which is more commonly present in~     African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less~     favorable recovery post stroke.~   "
5723|NCT02982265|"~     Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies~     and remains a leading cause of maternal and perinatal mortality and morbidity.~      Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure~     ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings~     taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and~     substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein~     concentration ≥ 300 mg/L or ≥ 1 + on dipstick in at least two random urine samples taken~     at least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.~      Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the~     same. However, the underlying causes of the disease remain largely unknown.~   "
5724|NCT02982252|"~     Losing the ability to walk can lead to fewer opportunities to socialize with friends and~     family and participate in the community. When this happens, powered wheelchairs can provide~     access to homes and communities, contributing to health and well-being. Training by a~     qualified occupational therapist allows an individual to use a powered wheelchair safely and~     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time~     consuming for people with cognitive and physical challenges. In this study, the~     investigators will ask participants with cognitive impairments to complete training with an~     occupational therapist using either a shared control wheelchair or training methods~     according to the standard of care. The investigators believe shared control training,~     entitled Collaborative Powered mobility Innovative Learning OpporTunity (CoPILOT) will~     enhance driving skill while maximizing safety learning. CoPILOT has the potential to enable~     people to participate more in their day to day lives and regain mobility independence.~   "
5779|NCT02981524|"~     This study will be looking at the objective response rate (ORR) as measured by RECIST in in~     patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated~     with CY/GVAX in combination with Pembrolizumab.~   "
5898|NCT02979977|"~     This is a single arm Phase II study for patients with recurrent or metastatic squamous cell~     carcinoma of the head and neck, who are previously treated with a platinum based regimen or~     with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of~     the combination of cetuximab and afatinib.~   "
5725|NCT02982239|"~     Evidence suggests that student athletes frequently experience sleep problems and are aware~     of the impact of sleep loss on mental and physical outcomes. As such, student athletes are~     motivated to improve sleep quality in order to improve their outcomes for overall athletic~     performance. This study will consist of two parts. The first part will be a survey. Fall~     athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a~     survey within the first week of their arrival on campus. The survey will assess multiple~     domains of student-athlete health, namely, sleep duration and quality, mood and depression,~     stress, and mental and physical well-being. The responses to the survey will be~     confidential, and students will be compensated for the survey. At the end of the semester,~     students will be invited to complete the survey again.~      Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the~     intervention, based on predetermined criteria. The intervention will include an information~     session where students may ask questions. Students will be sent text message reminders about~     adherence to the program and will be asked to monitor their sleep quality with sleep~     diaries. The intervention will consist of the half of the 40 chosen students, (20 students),~     who will be provided with blue blocking glasses, a bright light-emitting diode (LED) light,~     and a fit bit. Please note that all of these items are commercially available and are not~     meant to be used to treat or prevent human illness nor injury and do not require FDA~     oversight. The blue-blocking glasses will ensure that blue light from electronic devices~     will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep~     earlier. The bright LED light will provide bright blue light in the morning to help students~     wake and an amber light to promote earlier bedtimes. The Fitbit will estimate sleep and~     physical activity as well as adherence to the program.~   "
5726|NCT02982226|"~     The objective of this clinical trial is to evaluate both the safety and efficacy of the~     ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as~     compared to a Corticosteroid Injection which is considered standard of care.~   "
5727|NCT02982213|"~     The purpose of the study is to evaluate if maternal anxiety is improved when a parturient~     gets her choice with regard to the presence of a companion during epidural catheter~     placement for labor analgesia. It will be focused on parturients having their first child~     with the current partner. Additionally, it will investigate the effect of ethnicity, health~     literacy (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as~     evaluated by the Pain Catastrophizing Scale), and the relationship of the support person to~     the parturient. The investigators hypothesize that there may be specific subgroups in which~     maternal anxiety is improved when a parturient gets her choice regarding the presence of a~     companion during labor epidural catheter placement; however, a significant improvement in~     maternal anxiety, when including all participants, will not be appreciated.~   "
5728|NCT02982200|"~     A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study~     conducted to assess the performance of the Medina Embolization Device when used in~     unruptured and ruptured intracranial aneurysms.~   "
5729|NCT02982187|"~     This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2~     complete block design in subjects with chronic obstructive pulmonary disease (COPD) to~     assess the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler~     (DPI) (closed triple therapy) versus delivering triple therapy using two different types of~     DPI (open triple therapy). The primary objective of the study is to evaluate the proportion~     of COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using~     combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all~     subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with~     either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the~     treatment sequences. At the end Visit 1, subjects will complete the inhaler preference~     questionnaire (PQ). There is no active treatment and subjects will continue to take their~     own prescribed COPD medication for the duration of the study. ELLIPTA and DISKUS are~     registered trademarks of the GSK group of companies; TURBUHALER is a registered trademark of~     AstraZeneca and HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH &~     Co. KG.~   "
5730|NCT02982174|"~     Compare the signal to noise ratio of each device at various retinal layers.~   "
5731|NCT02982161|"~     The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in~     male and female adult subjects to demonstrate the efficacy of MR308 in the treatment of~     acute moderate to severe pain after the extraction of at least two third molars requiring~     bone removal.~   "
5732|NCT02982148|"~     This study is designed to compare the effectiveness of intradermal injection and~     subcutaneous injection with methylene blue for early-stage breast cancer patients who need~     sentinel lymph node biopsy.~   "
5733|NCT02982135|"~     The investigators conducted a prospective multi-center study assessing the effect of direct~     bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.~   "
5734|NCT02982122|"~     Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains~     25% and only 40% of patients survive without major handicap. Medical/surgical interventions~     aim to maintain adequate brain perfusion, which is critically dependent on cerebral~     perfusion pressure (CPP); calculated as the difference between mean arterial pressure (MAP)~     and intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on~     population means. However, this 'one size fits all' approach is flawed, because the relation~     between CPP and brain perfusion varies between individuals. Further, this approach takes no~     account of autoregulation, a key protective mechanism that maintains cerebral perfusion~     despite CPP fluctuations.~      Autoregulation is variably preserved following TBI, and there are large between patient~     variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual~     CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a~     certain time window. The investigators have shown that maintenance of CPP close to CPPopt is~     associated with improved outcomes. These data pose the hypothesis that optimisation of~     management in individuals may be achieved by using the zone of optimal autoregulation as a~     basis for defining individualised CPP targets.~      The investigators propose, together with collaborators in the CPPopt study group~     (Maastricht, Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study~     to develop a protocol for a definitive outcome randomized controlled trial (RCT). This study~     aims to develop protocols for CPPopt guided critical care, and show that they maintain~     patients closer to their optimum perfusion levels than standard protocols which keep above a~     population CPP threshold of 60 mmHg.~      Hence, the main objective is to offer clinicians monitoring and therapy algorithms that~     achieve individualized optimal CPPopt targets and potentially improve TBI outcome.~   "
5735|NCT02982109|"~     The investigators have recently reported a relationship between pain induced by peripheral~     venous cannulation and postoperative pain. The purpose of this study is to validate this~     method of postoperative pain prediction in a larger cohort subjected to different types of~     surgery.~   "
5736|NCT02982096|"~     The purpose of this study is to determine if healing occurs within 21 days of treatment with~     the use of the CellutomeTM device for fractional epidermal micro grafting compared with~     standard acellular techniques (creams and membrane dressings).~      Healing will be determined by time to ≥90% epithelialization within 21 days of treatment.~     Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale~     (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to~     standard techniques without application of skin cells (epidermal grafts = acellular) and~     will be measured twelve months post treatment application, ± 6 months.~   "
5737|NCT02982083|"~     The investigators select 40 postmenopausal women suffering from RA with 2.5<DAS28<5.5~     referring to rheumatology clinics of Mashhad university of medical sciences and randomly~     divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are~     administered double blind. In the beginning, total bone mineral density (BMD) assessment is~     carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3~     months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are~     allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist~     monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At~     the end of month 3, disease activity and probable complications are evaluated and compared~     in 2 groups. Classic regimen should be started for every patient who doesn't enter remission~     phase in first 3 months.~      In 4th month, DMARD regimen is administered and then patients are visited every 2 months.~     Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another~     total BMD test is carried out and then data are analyzed including changes in BMD, DAS28,~     EULAR response criteria and HAQ-DI score.~   "
5738|NCT02982070|"~     The aims of this study are to (1) assess the extent of psychological distress for incoming~     first-year students at the University of Tulsa (Part 1), (2) assess the impact of mental~     toughness training on the trajectory of psychological well-being and academic success (Part~     2), (3) assess the impact of mental toughness training on neural and behavioral reactivity~     to affective stimuli and decisions (Part 3), and (4) examine genetic markers of resiliency~     in college populations and interactions between genetic markers and response to mental~     toughness training (Part 2).~   "
5739|NCT02982057|"~     The aim of the present study is to compare the evolution of non culprit lesions after~     treatment by BVS versus optimal medical therapy at 2-years follow- up~   "
5740|NCT02982044|"~     The purpose of this study is to determine if different blood flow patterns change artery~     function. We hypothesize that the temporary induction of an oscillatory blood flow pattern~     will result in an immediate improvement in artery function. Participants will be asked to~     come to the Vascular Dynamics Lab (IWC E102) at McMaster University for a total of 3 visits.~     The first visit will allow the participant to get comfortable with the lab and the upcoming~     tests; and the next 2 visits will be scheduled at the same time of day to collect data. For~     visits 2 and 3, participants will be asked to arrive after a 4 hour fast. At these visits,~     ultrasound imaging will be used to examine the arteries and how they may change when blood~     flow patterns through an artery in the arm are changed. To change blood flow in the arm,~     heat, rhythmic squeezing of the forearm with a cuff, or handgrip exercise will be used.~     These interventions will be applied to the left forearm, from the elbow to the fingertips. A~     trained technician will also draw a blood sample during both data collection visits. A total~     of 10 participants will be recruited for the entire study.~   "
5741|NCT02982031|"~     The primary objective of this study was to compare ultrasound visibility of the lumbar~     plexus at the intertransverse space between paramedian transverse scan and shamrock~     technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the~     secondary objective was to assess ultrasound visibility of each relevant structure and~     overall visibility between these two methods.~   "
5742|NCT02982005|"~     The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in~     subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to~     receive KHK4827 or placebo for 12 weeks~   "
5743|NCT02981992|"~     In this observational study, the investigators evaluated the Treg number and function in a~     population of patients undergoing hemodialysis (HD).~      In particular, the investigators considered the relationship of Treg cell status with the~     different HD modalities and clinical parameters.~   "
5744|NCT02981979|"~     The purpose of this study is to investigate the efficacy and Safety of Leflunomide in~     Patients With Active Phase of Takayasu's Arteritis~   "
5745|NCT02981966|"~     Researchers hope to determine the organ (liver and/or kidney) responsible for the increase~     in endogenous glucose production (EGP) following the induction of glucosuria (when glucose~     is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.~   "
5746|NCT02981953|"~     The current management of tricuspid regurgitation (TR) is either conservative (by~     medication) or by surgery, usually in concomitant with other valves repair or replacement.~     TR can worsen or appear late after successful mitral valve surgery which portends a poor~     prognosis .However, standard surgical approaches requiring cardiopulmonary bypass and~     especially second surgery have an excessive risks. Thus many patients are denied surgery~     because of unfavorable risk-benefit balance. Therefore there is a need for novel devices~     enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid~     annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques~     (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the~     beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband~     System is expected to allow for treatment of patients that would otherwise not undergo~     Tricuspid valve repair due to the invasiveness of current techniques.~      The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for~     treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September~     2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty,~     however deployed on the beating heart through a transvenous approach. The CE mark study with~     30 subjects has been completed and documented significant reduction of severity of MR and~     improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ),~     Ney York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate~     to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system~     for repair the Tricuspid Regurgitation.~   "
5747|NCT02981940|"~     This research study is studying a targeted therapy as a possible treatment for recurrent~     glioblastoma (GBM).~      The following intervention will be used in this study:~      -Abemaciclib~   "
5748|NCT02981927|"~     To evaluate the early metabolic responses (whole body and within muscle tissue) to a single~     day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of~     inactivity per se vs alterations in diet~   "
6007|NCT02978560|"~     The aim of this project is to demonstrate that fluorescence-mediated photoplethysmography~     (FM-PPG) is capable of routinely acquiring the tissue perfusion data sufficient to detect~     and monitor skin tissue perfusion anomalies.~   "
5750|NCT02981901|"~     No structured organization for ovarian first line management emerges in France. Management~     across France seems to depend on regional contexts.~      Regions display no specific organization or delineate regional network for the ovarian~     cancer management or report centralized management revolving around referent centers. These~     different templates present a major problem in identifying differences, costs and benefit.~      To deal with this issue the Investigators propose a health economic evaluation based on~     cost-effectiveness analyses, completed with a budget impact analysis. This study will~     investigate the cost-effective management of patients with initial ovarian cancer using~     databases representative of different parts of French territories.~   "
5751|NCT02981888|"~     The purpose of this study is to find out the relationship between the bile acids, fatty~     acids (fatty acids are part of the diet) and bacteria that are present in the intestines.~   "
5752|NCT02981875|"~     Children with reading eye movement problems were recruited for this study. The treatment~     group was provided with oculomotor training for 8 weeks, the control group was given placebo~     exercises.~   "
5753|NCT02981862|"~     The current project is based on the assumption that a diagnosis of human papillomavirus~     associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical~     Cancer, Vulvar Cancer, Anal Cancer or Oropharynx Cancer at any stage of the disease and~     including surgical treatment for the small tumors.~   "
5754|NCT02981849|"~     The purpose of this study is to address the needs for efficient and informative measurement~     for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT)~     strategies. The investigators will undertake a longitudinal cohort study to build and~     validate a substance specific measurement battery that includes patient-centered and~     intermediary outcomes which can be integrated into a range of healthcare and research~     settings. The results of this project will enable evaluation of SBIRT trials and clinical~     efforts by validating a parsimonious set of measurement tools that can be incorporated into~     electronic health records. The primary goal of the proposed project is to develop a set of~     brief, valid tools that will allow both researchers and clinicians to collect information~     that enables evaluating and refining brief interventions.~      The main objective is to define and disseminate a set of brief and easy to administer~     measures that accurately detect 1) substance use frequency, 2) substance-specific patient~     centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific~     aim addressed in this project is to develop and administer an assessment battery that~     includes novel questions assessing substance use to be validated against criterion standard~     measures both cross-sectionally and longitudinally.~   "
5755|NCT02981836|"~     The purpose of this study is to evaluate the protective effect, safety and immunogenicity of~     a live attenuated varicella vaccine in healthy children.~   "
5756|NCT02981823|"~     To provide information on reducing the incidence of periprosthetic fractures during hip~     replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic~     fractures and their effects on hip functional recovery.~   "
5757|NCT02981810|"~     To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation~     can create changing in the tonsillar medium for recurrent tonsillar infections and stop the~     recurrent infections?~   "
5758|NCT02981797|"~     This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as~     standard of care.~      Participants will take part in this research study because they have chosen Radium 223~     treatment for their prostate cancer that has spread to the bone and causing pain.~     Investigators want to find out if a blood test performed before and after the Radium 223~     treatment will help to understand how prostate cancer cells react to this therapy.~      In this pilot study, researchers want to find out if Radium 223 given as part of standard~     treatment for prostate cancer can decrease the number of circulating prostate cancer cells.~     Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the~     changes in the number of circulating prostate cancer cells before and after Radium 223,~     researchers would also like to look at the changes in a DNA damage marker, called gamma~     H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223.~     Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same~     tube of blood that is used for assessing the changes in the number of circulating prostate~     cancer cells.~   "
5759|NCT02981784|"~     Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive~     (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This~     study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib~     versus allogeneic stem cell transplantation (allo-SCT).~   "
5760|NCT02981771|"~     Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim~     of this study is to explore the effect of specific exercise program based on balance and~     coordination on stability parameters~   "
5761|NCT02981758|"~     A comparison of reported estimated blood loss with quantified blood loss in all patients~     whose medical records indicate Triton was used during their vaginal delivery.~   "
5762|NCT02981745|"~     This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B~     cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's~     macroglobulinemia (WM).~      The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety~     and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin~     lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia~     (WM).~   "
5776|NCT02981563|"~     The aim of this project is to test and evaluate a nursing intervention, Time Together (TT),~     created to enable quality interactions between patients and staff in psychiatric inpatient~     care. The research questions are:~      Does TT influence the quality of interactions between staff and patients? Does TT influence~     patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of~     perceived stress and levels of stress of conscience? Does TT influence the prevalence of~     coercive measures, mean length of hospital stay and the use of PRN medication?~      In parallel, a process evaluation will be conducted, answering questions such as:~      How do staff and patients describe their experiences of the intervention and how do~     contextual factors influence the effects of the intervention? What are the relationship~     between the outcome variables and the degree of compliance with the intended intervention?~     What problems are there with recruitment and dropouts?~   "
5763|NCT02981732|"~     For nearly 112 million patients with osteoporosis in China, it is of great significance for~     preventing and treating by clearly understanding the molecular mechanism of kidney~     deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is~     an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism~     for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding~     of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe~     impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system~     using the technology of adenovirus associated virus. ②explore impacts of over-expression and~     silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③~     analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon~     immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone~     metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone~     metabolism, so as to demonstrate if the hypothesis of this study that the molecular~     osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP)~     is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal~     system on bone metabolism is right or not.~   "
5764|NCT02981719|"~     The aim of this study was to observe the survival status, recurrence and death time of~     patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and~     overall survival of the patients were evaluated respectively.~   "
5765|NCT02981706|"~     This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication~     rates and functional status decline in subjects age 70 years and older referred for vascular~     access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus~     arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and~     undergo measurements of functional status including gait speed, grip strength, and~     self-reported function over 6 months. The primary hypothesis to be tested is that AVF~     placement will result in a higher proportion of primary access failure as defined by a~     binary composite primary endpoint of an unsalvageable access or an immature access or a~     non-functional access measured at 6 months compared to AVG placement. In addition, the study~     will evaluate whether AVF placement and a greater number of access procedures will result in~     a greater decline in functional status as measured by the average change over 6 months in~     gait speed, grip strength, and self-reported function as assessed by the Disabilities in~     Arm, Shoulder and Hand Survey.~   "
5766|NCT02981693|"~     The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP~     as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients~     needing root canal treatment were enrolled and allotted into either iRoot SP group or AH~     Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according~     to their arms. Assessment of postoperative pain was done 1 week after root canal obturation~     using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations~     were carried out. Statistical analysis at P < 0.05 was conducted to measure difference~     between the arms.~   "
5767|NCT02981680|"~     Background:~      Acute kidney injury (AKI) following coronary artery bypass graft (CABG) surgery is a major~     complication occurring in 1% to 53% of patients (depending on how it is defined) with the~     pooled rate of 18.2% and unfortunately 2.1% of them require renal replacement therapy.~     Cardiopulmonary bypass (CPB)-associated AKI increases mortality 2-4 fold regardless of AKI~     definition. It is also associated with increased risk of postoperative stroke, acute~     myocardial infarction, cardiac tamponade, heart failure, and lengthened intensive care unit~     and hospital stays. Even minor elevations of postoperative serum creatinine (SCr) have been~     associated with a significant increase in 30-day mortality, from a 3-fold increase risk for~     a small elevation of up to 0.5 mg/dL from baseline to an 18-fold increase risk of death with~     a SCr rise greater than 0.5 mg/dL.~      The pathogenesis of CPB-associated AKI is complicated and includes hemodynamic, inflammatory~     and other mechanisms that interact at a cellular level. To date, despite several clinical~     trials of pharmacologic interventions, none of them have demonstrated conclusively efficacy~     in the prevention of AKI after cardiac surgery.~      Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ~     or tissue, provokes a protective effect that can reduce the mass of infarction caused by~     vessel occlusion and reperfusion. In CABG surgery, cardiomyocyte injury caused by myocardial~     protection failure is predominantly responsible for adverse outcomes. RIPC was shown to~     reduce troponin release 24 h postoperatively in children undergoing corrective surgery for~     congenital heart disease. Other studies demonstrated that RIPC using brief ischemia and~     reperfusion of the upper limb reduces myocardial injury in adult patients undergoing CABG~     surgery.~      Due to the similarities between the mechanisms of ischemia-reperfusion injury produced by~     RIPC and those proposed for AKI after CPB, we decided to test the hypothesis that RIPC~     prevents AKI in patients undergoing CABG surgery.~      Methods:~      170 patients who fulfill all inclusion and exclusion criteria will be divided into case and~     control groups (85 patients in the case and 85 patients in the control group).~      Patients in the treatment group will receive three sequential sphygmomanometer cuff~     inflations on their right upper arm after induction of anesthesia in the operating room. The~     cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with~     five minutes deflation in between inflations. Following this pre-conditioning phase, surgery~     will be started. The entire pre-conditioning phase will last 30 minutes.~      Patients in the control group will have the sphygmomanometer cuff placed on their right~     upper arm, but the cuff will not be inflated. Similar to patients in the treatment group,~     patients in the control group will undergo the same 30 minute delay before starting surgery.~      Complete blood count (CBC), SCr, liver function test (LFT), prothrombin time (PT), partial~     thromboplastin time (PTT) and urine analysis (U/A) will be checked before surgery.~      After surgery, complete blood count (CBC) and SCr will be checked daily. If AKI occurs, it~     will be managed and dialysis will be done if the patient requires it. All patients will~     undergo electrocardiogram, LFT, electrolytes, prothrombin time (PT), and partial~     thromboplastin time (PTT) after CABG surgery during hospital course~   "
5768|NCT02981667|"~     Previous research is equivocal concerning if high intensity interval training is viewed as~     more aversive versus moderate exercise. Our data in active men and women showed that~     interval training is viewed as more enjoyable than higher volume moderate exercise.~   "
5769|NCT02981654|"~     This is a prospective, open-label, multi-center, non-comparative study that will be~     conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary~     incontinence (SUI).~      Following the screening period, including urodynamic assessment to confirm SUI, each subject~     will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of~     one year. The main efficacy endpoint in this study is defined as significant improvement~     (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months~     visit. Various subjective and objective measures of incontinence severity, quality of life,~     sexual function and tissue effects will be performed at follow up.~   "
5770|NCT02981641|"~     The purpose of this study is to find the better radiation therapy between intraoperative~     radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).~   "
5771|NCT02981628|"~     This phase II trial studies how well inotuzumab ozogamicin works in treating younger~     patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not~     respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to~     a toxic substance and may help find cancer cells that express CD22 and kill them without~     harming normal cells.~   "
5772|NCT02981615|"~     Infections are a major and prevalent life-threatening complication among patients with~     myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents~     after chemotherapy in MDS patients remains controversial and there are no clinical~     guidelines for infection prophylaxis in this clinical setting. We will conduct a prospective~     study to evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the~     rate of febrile episodes/infections in Azacytidine treated MDS patients.~   "
5773|NCT02981602|"~     To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive~     patients with chronic hepatitis B virus infection~   "
5774|NCT02981589|"~     The main purpose of the present study was to explore the weaning failure rate from invasive~     mechanical ventilation and to identify risk factors of weaning failure.~   "
5775|NCT02981576|"~     Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and~     neurological deficits in injured individuals. The limited ability of the Central Nervous~     System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery~     of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated~     accidents, falls, and violence-related injuries.~      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,~     tissue engineering and regenerative medicine based approaches have been proposed as~     alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed~     promising results in several studies. Our aim is to assess and compare the safety and~     effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.~   "
5795|NCT02981316|"~     The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the~     treatment of recurrent CDI in subjects who have had at least one recurrence after a primary~     episode (i.e., at least two episodes) and have completed at least two rounds of~     standard-of-care oral antibiotic therapy.~   "
5780|NCT02981511|"~     Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood~     oxygen saturation. This study is designed to assess whether the Optiflow system can~     efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it~     could be used in emergency anaesthesia. If so, it would be then be in place in the case of~     difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then~     maintain oxygenation seamlessly.~   "
5781|NCT02981498|"~     To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,~     5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular~     carcinoma (HCC).~   "
5782|NCT02981485|"~     Breast cancer related lymphedema (BRCL) is a common complication following breast cancer~     treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in~     the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities,~     impaired physical mobility, mental discomfort, reduced quality of life and erysipelas.~     Therapy of BRCL is divided into conservative and operative methods. However, all the above~     method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In~     this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and~     safety of this method will be also assessed.~   "
5783|NCT02981472|"~     To investigate the safety and pharmacokinetics of apixaban in children with congenital or~     acquired heart disease who have a need for anticoagulation.~   "
5784|NCT02981459|"~     The specific purpose of this study is to provide objective data in prospective open label~     design (n=40) to support the use of Mirabegron as a treatment for pain related urinary~     frequency and urgency. Women with bladder pain have a poor response to traditional~     anticholinergic therapy for their symptoms of frequency and urgency.~   "
5785|NCT02981446|"~     The purpose of this study is to investigate the intraocular pressure-lowering effect and the~     safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in~     subjects with open angle glaucoma or ocular hypertension.~   "
5786|NCT02981433|"~     Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by~     physical disabilities, limitation of daily activities (such as sitting and walking), sexual~     dysfunction and psychologic disability. Originally suggested by McKay, the term vulvodynia~     has also been suggested by the International Society for the Study of Vulvar Disease Task~     Force to describe any vulvar pain. The incidence and prevalence of vulvodynia have not been~     well studied. Age distribution for the condition may range from the 20s to the 60s, and it~     is limited almost exclusively to white women. Obstetric and gynecologic history is usually~     unremarkable. Risk-taking sexual behavior is rare, and few patients have a history of~     sexually transmitted diseases. Vulvar pain usually has an acute onset, at times associated~     with episodes of vaginitis or certain therapeutic procedures of the vulva (cryotherapy or~     laser therapy). In most cases, vulvodynia becomes a chronic problem lasting months to years.~     Vulvar pain is frequently described as burning or stinging, or a feeling of rawness or~     irritation.~      Most patients consult several physicians before being diagnosed. Many are treated with~     multiple topical or systemic medications, with minimal relief. In some cases, inappropriate~     therapy may even make the symptoms worse. Since physical findings are few and cultures and~     biopsies are frequently negative, patients may be told that the problem is primarily~     psychologic, thus invalidating their pain and adding to their distress.~   "
5787|NCT02981420|"~     A youth's contact with the juvenile justice system represents an opportune moment for~     suicide screening and brief suicide intervention for indicated youth. This study will~     provide data on the novel implementation of an evidence-based brief suicide intervention,~     safety planning, administered by front-line juvenile court staff for suicidal court-involved~     non-incarcerated youth. Data will inform the dissemination and implementation of suicide~     brief interventions to be delivered by front-line staff at the time of mental health~     screening in the juvenile justice system. The proposed study is consistent with the NIMH~     Strategic Plan by testing an intervention for effectiveness in community settings (Strategy~     3.3) and establishing a research-practice partnership to improve D&I of evidence-based MH~     services (4.2). The unique service delivery by JJ court staff also supports the NIMH goals~     to develop innovative service delivery models (Strategy 4.3) as well as validate a MH~     intervention for an underserved population (Strategy 4.1). This proposal also addresses the~     Healthy People 2020 goals of reducing suicide attempts (MHMD-2).~   "
5788|NCT02981407|"~     The purpose of this study is to compare two red blood cell transfusion strategies (liberal~     and restrictive) for patients who have had an acute myocardial infarction and are anemic.~   "
5789|NCT02981394|"~     The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including~     osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be~     sparse. The purpose of this study is collect a longitudinal case series of patient reported~     outcomes following BMAC injections for musculoskeletal conditions including osteoarthritis,~     tendinopathy and injuries to ligaments, tendons and muscles.~   "
5790|NCT02981381|"~     The investigators propose a small, two-site, sham-controlled pilot study of synchronized~     Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress~     disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and~     mood symptoms.~   "
5791|NCT02981368|"~     This study evaluates the safety and diagnostic performance characteristics of 18F-DCFPyL~     Injection in patients with at least high risk prostate cancer who are planned for radical~     prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or~     metastatic disease willing to undergo biopsy (Cohort B).~   "
5792|NCT02981355|"~     This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold~     with microfracture versus microfracture alone on short and long term clinical benefit in~     patients with cartilage lesions of the femoral condyle requiring operative management.~   "
5793|NCT02981342|"~     The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in~     combination with other drugs versus standard of care in participants with previously treated~     metastatic pancreatic ductal adenocarcinoma (PDAC).~   "
5794|NCT02981329|"~     The purpose of this study is to determine whether metformin is effective in the treatment~     for sickle cell anemia (SCA) and non-transfusion dependent thalassemia (NTDT).~   "
5808|NCT02981147|"~     The aim of this study is to look for effectiveness in controlling the frequency of cough and~     safety of Phytus.~   "
5796|NCT02981303|"~     Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in~     subjects with advanced melanoma or metastatic TNBC~      Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination~      Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint~     inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and~     adaptive immune systems in those subjects who have failed 1st line therapy~      The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12~     subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC)~     subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in~     Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting~     dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of~     subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced~     to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of~     n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response~     in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each~     tumor type must be observed in order to proceed to Stage 2.~      Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For~     the dose that meets the Stage 1 safety criterion, success will be declared if at least 4~     amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42~     subjects with TNBC achieve an objective response.~   "
5797|NCT02981290|"~     This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way~     crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites~     from 4 tablet formulations in healthy participants.~   "
5798|NCT02981277|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of~     various bronchopulmonary diseases. Most patients tolerate the procedure well although cough~     is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy~     would be significantly improved with control of cough. Use of sedation during bronchoscopy~     has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy~     is routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of transtracheal/transcricoid injection versus spray as~     you go method for lignocaine delivery to the airways during bronchoscopy. This study would~     help to determine the procedure comfort for the patient while using the~     transtracheal/transcricoid method vs the spray as you go method.~   "
5799|NCT02981264|"~     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly~     performed for diagnosis of mediastinal pathologies. The procedure can either be performed~     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients~     tolerate the procedure well although cough is often reported as a distressing symptom.~     Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia.~     There is limited literature on the efficacy of transtracheal/transcricoid injection versus~     spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study~     would help to determine the procedure comfort for the patient while using the~     transtracheal/transcricoid method vs the spray as you go method.~   "
5800|NCT02981251|"~     The purpose of the study is to evaluate the effect of health education on blood pressure~     reduction compared to usual care among uncontrolled hypertensive patients of suburban~     community of Surkhet district of Nepal.~   "
5801|NCT02981238|"~     The aim of the study is to evaluate the effect of a one-month supplementation with~     Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac~     so-called adjustment subjects (occasional or short-term insomnia)~   "
5802|NCT02981225|"~     The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms~     in patients with mild to moderate major depression in a strategy with Phytostandard®~     Rhodiola-Saffron supplementation~   "
5803|NCT02981212|"~     The purpose of this clinical study is to evaluate the efficacy and safety of that test group~     was administered with Mycophenolate Mofetil in combination with corticosteroid in patients~     with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without~     administration of Mycophenolate Mofetil.~   "
5804|NCT02981199|"~     Comparison of the efficacy and safety of microtransplantation and autologous transplantation~     in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been~     observed. To identify the role of microtransplantation in the treatment of multiple myeloma.~   "
5805|NCT02981186|"~     The study is a prospective randomised controlled study. The patients get monolateral IOL~     implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs~     consisting of the same optical design. The difference between the IOLs is the material~     (hydrophilic and hydrophobic).~      To decide which eye receives POD F and which eye receives POD F GF, a randomization table~     will be provided to the principle investigator.~   "
5806|NCT02981173|"~     The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen~     in chronic cluster headache. Subjects will be randomized to receive oral placebo, low dose~     psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5~     days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen~     in order to document headache frequency and intensity before, during, and after the pulse~     regimen.~   "
5807|NCT02981160|"~     The purpose of the research is to determine energy expenditure rates and diet and/ physical~     activity metabolic features of an individual using current state technologies and a new~     technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot~     study which intent is to validate this device for use in the weight loss patient population.~      This study will involve research of metabolic physiological parameters that are measured~     through the breath of the individuals, together with other physical parameters (weight,~     height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood~     pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary~     physical activities. The study will involve withdrawn of breath samples at resting~     conditions, and under diets or physical activities regimes.~      This instrument will assist our patients in terms of tailoring their diet/nutrition through~     their weight loss journey prior and after surgery. As a new technology, it will be an~     excellent tool for compliance assessment and engagement with the Weight Loss Program as well~     as for long term follow up.~   "
5811|NCT02981108|"~     This is a Phase 1/2, open-label, multicenter study of HS-10296 with dose escalation, dose~     expansion and extension cohorts in locally advanced or metastatic non-small-cell lung cancer~     (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor~     receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. The study is designed to evaluate~     safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and~     orally (PO) administered HS-10296. The overall study design is shown in the flow chart~     below, which consists of 3 phases: dose escalation, dose expansion and extension cohort.~   "
5812|NCT02981095|"~     Investigators aimed to evaluate the impact of bupivacaine administration into the surgical~     field after total thyroidectomy on post-operative pain and analgesic requirement with a~     double-blind, prospective, clinical, randomized study.~      Pain assessment was performed with the visual analog score (VAS). Participants were~     pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One~     group received a 10 ml of bupivacaine solution while the other group was treated with the~     same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total~     thyroidectomy procedure. All participants were anesthetized and operated with the same~     anesthesia and surgical team.~   "
5813|NCT02981082|"~     A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic~     Sclerosis-Pulmonary Hypertension (SSc‐PAH) patients. The study will determine safety and the~     primary outcome variability for DMF in treating SSc‐PAH; the primary outcome of clinical~     efficacy in this pilot trial will be improvement in 6‐minute walk distance (6MWD).~   "
5814|NCT02981069|"~     In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous~     glucose production) and plasma glucose concentration in diabetic subjects. Researchers will~     examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and~     fall in plasma glucose concentration.~   "
5815|NCT02981056|"~     The objective of the study is to investigate the effects of different skincare regimens on~     infants (0-6 months old at the start of the study), specifically focusing on moisturization~     effect. Outcome measures include moisturization, skin pH, skin barrier, physiological~     parameters, reactivity and skin microbiome.~   "
5816|NCT02981043|"~     Clinical studies so far have been limited, and larger volume and multi-center studies~     studies are needed. The purpose of this pilot study is to look for a clinical correlations~     between the aggressivity panel developed from biomarkers thought to affect the progression~     or aggressivity of endometriosis, pain and quality of life.~      Our goal with the study is find a correlation between the aggressivity of endometriosis~     with clinical factors determined in our study questionnaires. The aggressivity panel was~     pioneered by the EndoDiag lab in France, and was created using markers thought to affect the~     activity or progression of endometriosis. This information could lead to a better~     understanding of the disease, and ultimately lead to more targeted therapies.~      If a patient returns for a second surgery we will ask their permission to use their slides~     from their first and seconed surgery to compare. The tissue that is being removed during the~     surgery as standard of care to make slides for the research study (there will not be an~     endometrial biopsy performed for research purposes with the second surgery). The slides from~     surgery 1 & surgery 2 will then be compared.~      If a clinical correlation is found with the aggressivity panel, the goal would be to create~     a local lab and tissue bank here in the United States that could provide a basis for~     collaborative national (even international) research. Also, if a correlation is found,~     future investigation will look at correlations of the aggressivity panel and fertility~     outcomes. Results of this pilot study will help to direct studies of treatment protocols of~     the various stages of aggressivity of endometriosis.~   "
5817|NCT02981030|"~     The study will examine how a simplified outpatient medical abortion procedure using~     mifepristone and misoprostol, with the option to take mifepristone at a place of woman's~     choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral~     administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with~     gestations through 70 days, as well as the acceptability of this method.~   "
5818|NCT02981017|"~     We propose a randomized, single-blinded, prospective trial in order to evaluate the efficacy~     of the Cook Biodesign ENT Repair graft in improving outcomes after the Draf III or~     Endoscopic Modified Lothrop procedure. The Cook Biodesign ENT Repair graft is a porcine~     intestinal submucosal xenograft which has been FDA approved for use as an adjunct to natural~     healing process in the sinonasal cavity. The Draf III or Endoscopic Modified Lothrop~     involved creating a large unified drainage pathway for refractory frontal sinusitis. After~     the procedure is completed, there is exposed bone along the frontal beak region which can~     become a nidus for inflammation, crusting and eventual scarring, leading to stenosis or even~     complete blockage of the frontal sinuses. The Cook Biodesign will be used to cover this~     exposed bone in order to potentially reduce the inflammation, crusting and scarring and~     possibly improve outcomes.~   "
5819|NCT02981004|"~     The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing~     the relation between the prosthetic GOA and the area of LVOT as potentially new parameter~     for the prediction of hemodynamic outcome. The results may possibly guide future valve size~     selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)~   "
5820|NCT02980991|"~     The study is a prospective, single-center, open-label, single-armed, phase II clinical~     trial. The aim of the study is to evaluate the radiological response rate (RR) of 2 cycles~     of neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage~     II and IIIA lung adenocarcinoma.~   "
5821|NCT02980978|"~     This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED~     randomized control trial. The study is being conducted by the Minneapolis Heart Institute~     Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical~     Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).~      The study will examine the impact of a registered dietitian-led, primary care integrated,~     telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual~     care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c~     <8%, not using tobacco and taking an aspirin as appropriate.~   "
5822|NCT02980965|"~     This was an open-label, randomized controlled trial that aims to compare the efficacy and~     safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant~     chemotherapy alone in ER-positive, HER2-negative breast cancer.~   "
5824|NCT02980939|"~     During exercise in the heat, there is a need to replenish fluids in order to avoid~     dehydration and decrease the risk for heat illness. What drives this urge to drink is the~     thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before~     there is a replenishing of fluids. However, there is little scientific evidence of where~     thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst~     itself influence exercise performance. Further, during rehydration studies, it is very~     difficult to successfully blind a subject to their drinking/hydration protocol. Previous~     studies that have blinded a subject to their drinking have used various methods such as~     intravenous fluid administration and/or nasogastric tubes. Therefore, the purpose of this~     research is to examine the mechanistic roles thirst inhibition plays while exercising in the~     heat while undergoing intravenous fluid administration. Specific attention will be directed~     to the cardiovascular and thermoregulatory function of the individuals. All blood,~     cardiovascular, thermoregulatory, and perceptual measures are shown in the diagram below.~   "
5825|NCT02980926|"~     The purpose of this study is to determine if a shorter-acting spinal anesthetic called~     mepivacaine has advantages over a longer-acting medication called bupivacaine.~   "
5826|NCT02980913|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population.~      Topically administered lubricants are the basis for treatment of this disease. Relief of~     symptoms in patients with moderate to severe dry eye disease is usually reached by the use~     of artificial tears during the day. Nighttime relief is often achieved by substances known~     to be more adhesive to the ocular surface, such as gels.~   "
5827|NCT02980900|"~     The present study will assess the effect of the type and timing of protein ingestion 6 days~     prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of~     muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.~   "
5828|NCT02980887|"~     It is recognized that patients with various forms of heart and lung disease exhibit varying~     degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular~     dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not~     well understood. Rapid advances in high throughput omic methodology, combined with powerful~     bioinformatics and network biology capability, have created the opportunity to conduct~     studies that broadly search for homologies and differences across the spectrum of disease~     states associated with pulmonary hypertension, and determinants of the spectrum of right~     ventricular compensation that accompanies these conditions~   "
5829|NCT02980874|"~     This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12~     months duration in treatment naïve subjects with RVO.~   "
5830|NCT02980861|"~     Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The~     application of minimally invasive surgery for advanced gastric cancer is gaining popularity.~     The investigators aim to compare the safety and feasibility of LTG and OTG for advanced~     proximal gastric cancer.~   "
5831|NCT02980848|"~     This Beast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational~     pragmatic comparative effectiveness research study using high-quality, prospectively~     collected data from BCSC registries to generate evidence on how breast density should be~     integrated into decision making around breast cancer screening and preoperative diagnostic~     work-up. We will augment existing BCSC registry infrastructure with additional prospective~     data collection and collection of patient reported outcomes (PROs), CISNET modeling of~     long-term screening outcomes, and qualitative data from focus groups with women represented~     in two aims.~   "
5832|NCT02980835|"~     Intercostal nerve block, performed under the guidance of videoscope, is a part of standard~     anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this~     double-blind, prospective, multi-center, randomized, controlled clinical trial the~     investigators aim to compare preemptive versus post-closure intercostal injection of~     ropivacaine in controlling post-video-assisted thoracotomy pain.~   "
5833|NCT02980822|"~     Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to~     the national spine registries in Sweden, Norway and Denmark, there is a difference in~     surgical incidence between these countries. The cause for this difference is not known. It~     may reflect a difference in incidence of lumbar disc hernia, but with a similar~     socio-economic and ethnical background in these countries, it is more likely that the~     differences are due to varying surgical indications. Comparing indications for surgery,~     patient reported outcome and factors predictive for outcome after surgery for lumbar disc~     decease in these countries could provide information about optimal indications for surgery.~      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between~     these countries, (ii) there are no differences in indications for surgery between these~     countries and (iii), factors that predict outcome are similar in these countries.~      Method of research: By using data from three Nordic national spine registers, investigators~     will compare baseline data, indications for surgery and patient reported outcome one year~     after surgery for lumbar disc decease. Register based studies have advantages such as large~     sample sizes, reflecting real life, but they also have limitations such as lower follow-up~     rates than clinical trials. A non-response analysis will be performed to take this into~     account.~   "
5834|NCT02980809|"~     The purpose of this study is to determine whether topotecan plus apatinib are superior to~     topotecan alone as second-line therapy in small-cell lung cancer.~   "
5835|NCT02980796|"~     Participants will complete 13 sessions. These include screening, 5 sessions where exercise~     or rest (according to group assignment) are paired with practice of a motor task, MRI and~     Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to~     assess neuroplasticity (ability for the brain to reorganize and create new connections).~   "
5836|NCT02980783|"~     This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic~     radial cheek line skin depressions.~   "
5837|NCT02980770|"~     Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common~     conditions in obesity, which may influence the prognosis in patients undergoing surgery.~     There is a need for simple screening tools to identify such patients at high risk. The~     current multicenter observational study aims to investigate occurrence of OSA and OHS in~     obese individuals undergoing elective open abdominal surgery and further address its impact~     on perioperative and postoperative complications.~   "
5838|NCT02980757|"~     The main purpose of this study is to assess comparative bioavailability of two test~     formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified~     release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate~     Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg~     gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15~     healthy adult subjects under fasting conditions. The second aim is to asses the safety of~     subjects and to determine other pharmacokinetic data.~   "
5839|NCT02980744|"~     The traditional approach to physical activity promotion in people with stroke has always~     emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe~     fast and break a sweat). For many people with stroke who often have difficulty with walking,~     achieving that intensity of activity is difficult. The result is that people with stroke~     spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of~     research shows that too much sitting has negative effects on health including larger waist~     circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of~     functioning, and premature death.~      This project tests a new approach to activity promotion that focuses on increasing~     light-intensity activity throughout the whole day while reducing sitting time. The new~     intervention is titled STand Up Frequently From Stroke (STUFFS) and is aimed at increasing~     self-confidence among people with stroke to sit less, stand up and walk around at frequent~     intervals during the day. Studies in the general population have shown that standing up and~     walking around frequently are beneficially associated with health indicators (lower waist~     circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce~     sitting and increase light-intensity activities appears feasible and sustainable and might~     be a first step to increase their daily energy expenditure.~   "
5840|NCT02980731|"~     The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on~     the quality of life of participants with chronic lymphocytic leukemia (CLL; a type of cancer~     affecting the blood and the bone marrow) including those with the 17p deletion or TP53~     mutation (local lab assessed) OR in CLL participants who have received prior B-Cell Receptor~     Inhibitor (BCRi) therapy. The starting dose of venetoclax is 20 mg once daily. The dose must~     be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants~     may continue receiving venetoclax for up to 2 years. After the treatment period,~     participants may continue on into a 2-year follow-up period.~   "
5841|NCT02980718|"~     Awareness of the sense of smell in the western population has been low. Most people do not~     think about the consequences of absence of smell (anosmia). Reduction in sense of smell~     (hyposmia) can influence everyday life. In situations of stress anosmia can be life~     threatening for example when there is a fire. Cooks may lose their job. Not being able to~     enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction~     (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of~     the nose and sinuses or head injuries. OD may be congenital, age related or associated with~     neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the~     first symptom of both Parkinson's and Alzheimer's disease several years before the mental~     changes occur.~      Knowledge and focus on OD has until recently been low among most physicians and treatment~     options have often not been available. Different approaches to improve OD have been tried~     with variable effect depending on the cause of OD. There are studies on corticosteroids,~     zinc gluconate and vitamin A. In recent years, olfactory training has been launched as a~     promising treatment option. Most studies with olfactory training are done with patients with~     OD. A recently published review describes 10 studies with olfactory training among 639~     patients and concludes that daily stimulation with odorants (odor concentrate) over a~     limited period time is a promising treatment. The suggested duration of olfactory training~     varies from 3 to 14 months. Different intensities of olfactory training were compared in~     patients with post-viral OD. Olfaction was more improved by the high concentration of~     odorant than by the low concentration.~      A small number of studies have shown that the olfactory nerve to some extent can be trained~     in persons with normal sense of smell, but we need more experience and structured studies to~     be able to conclude with greater certainty about the effect of olfactory training in this~     population.~      This study examines whether intensive olfactory training improves the sense of smell more~     than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines~     self-evaluation of olfactory function.~   "
5842|NCT02980705|"~     This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the~     efficacy and safety of SUNPG1622.~   "
5843|NCT02980692|"~     This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to~     demonstrate the safety and efficacy of SUNPG1623~   "
5844|NCT02980679|"~     A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of~     the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct~     imaging and measurement of thyroid uptake.~      Doctors and researchers at the University of Alberta have developed a new method of~     producing 99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope~     and Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new~     production method will provide another source of 99mTc Pertechnetate. The aim of this study~     is to confirm that CTC is safe and can be used interchangeably with G-PERT.~   "
5845|NCT02980666|"~     The purpose of this study is to determine if an investigational treatment (teduglutide) is~     safe and effective in Japanese children (age 1 through 15 years of age) with SBS who are~     dependent on parenteral support. This study will also evaluate how teduglutide moves through~     the body (pharmacokinetics) and how it affects the body (pharmacodynamics).~   "
5846|NCT02980653|"~     Primary Objective:~      To evaluate the population prevalence of critical body weight loss ( more than 5% from~     baseline) in patients with Head and Neck cancer.~      Secondary Objectives:~      To evaluate the impact of appetite, and performance status; To evaluate the change of~     quality of life (QoL); To evaluate the incidence of infection and hospitalization; To~     evaluate the safety profiles~   "
5847|NCT02980640|"~     The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim~     to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of~     persons living with MS in Switzerland.~   "
5860|NCT02980471|"~     The purpose of this study is to demonstrate the correlation of the Compensatory Reserve~     Index (CRI) numeric and graphical trend readings to intravascular volume changes as compared~     to graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots)~     and to stroke volume as measured by the Nexfin monitor during the same graded blood removal~     period. Enrollment includes both men and women.~   "
5861|NCT02980458|"~     The present study will be conducted in order to compare the bioavailability of the generic~     Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed~     Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both~     containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised~     after single dose administration of each one tablet.~   "
5848|NCT02980627|"~     Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high~     risk for diabetes-related medical complications and premature death. Conventional eating~     disorder (ED) treatments are not as effective for these patients, suggesting that they need~     a more tailored treatment approach and one that includes intervention at the time and place~     when they are making decisions about their diabetes self-management. The goal of treatment~     development project is to modify an existing mobile application (app) for EDs (Recovery~     Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who~     intentionally omit their insulin for weight control, and test whether app-supported~     individual treatment decreases eating disorder (ED) symptoms and improves metabolic control.~     The investigator will also gather preliminary data on the impact of the intervention on~     health care utilization and costs and calculate attrition to assess feasibility.~      The investigators hypothesize that (1) participants will evidence significant decreases in~     mean blood glucose, (2) participation in routine medical care will increase and emergency~     visits will decrease, (3) the percentage of time participants are hyperglycemic will~     decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on~     the EDE will decrease.~   "
5849|NCT02980614|"~     MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its~     branches inside the same sequence. The objective of the project is to compare the~     regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D~     MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow~     quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA~     flow =LeftPA flow +RightPA flow ? ).~   "
5850|NCT02980601|"~     The purpose of this research study is to compare the forearm free flap of patients with a~     traditional split thickness skin graft and those repaired with Integra (a skin substitute~     that helps to provide wound closure) and a split thickness skin graft. The study team will~     be looking at the subject's satisfaction with how the skin graft site looks and how well the~     skin graft site is functioning.~   "
5851|NCT02980588|"~     Poorly glycemic control in critically ill patients can increase their mortality, while safe~     and efficient glucose control is laborious and time-consuming. The Space Glucose Control~     which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose~     target range safely and effectively through regulating insulin dose rate, and decrease the~     glucose variability. This study is a random controlled trial involving the patients with~     sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of~     blood glucose control between SGC directed and conventional treatment. At last, the trial~     results can determine whether the Space Glucose Control can control blood glucose safely and~     effectively in the patients with sepsis in intensive care units.~   "
5852|NCT02980575|"~     This study is aimed at determining whether listening to music during exercise will improve~     health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD).~     Half of the participants will listen to music while they exercise and half will not listen~     to music. The study will follow participants during their pulmonary rehabilitation program~     and for 6 months following completion of the program.~   "
5853|NCT02980562|"~     Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has~     proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation.~     However, currently available aqueous purgative formulations are poorly tolerated. The aim of~     this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg)~     formulation to determine the quality of bowel cleansing and patient tolerability.~   "
5854|NCT02980549|"~     Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is~     defined as a dissociated state of consciousness, occurring on awakening from general~     anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are~     not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common~     problem in pre-school children, with estimates of the incidence ranging from 10-70% of~     children in this age group. These children are agitated, seemingly unaware of their~     surroundings, and typically do not respond to parents or caregivers. They are therefore at~     risk for self-inflicted traumatic injury and complications secondary to disruptions of~     intravenous lines, surgical incisions, or drains. Children with ED typically require more~     resources in the postoperative period than children who do not exhibit ED. Predicting the~     likelihood of ED would allow for better allocation of resources in the post-anesthetic care~     unit (PACU).~      The peak incidence of ED in children occurs in the same age range at which the peak~     incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar~     to the description of ED; the American Academy of Sleep Medicine defines parasomnias as~     undesirable physical events or experiences that occur during entry into sleep, within sleep~     or during arousals from sleep. Parasomnias can be diagnosed using a sleep questionnaire.~      The purpose of this pilot study is to determine the incidence of ED and PS in our~     population, in order to determine the number of patients necessary to enroll in a larger~     study to either confirm or reject the hypothesis that ED and PS are correlated.~   "
5855|NCT02980536|"~     The purpose of this study is to evaluate the mutation pattern of epidermal growth factor~     receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient~     with liquid biopsy.~   "
5856|NCT02980523|"~     Hypothesis PRO-157 (Project-157) ophthalmic solution is as safe and effective, demonstrating~     non-inferiority, when compared against Moxifloxacin and Gatifloxacin in the treatment of~     conjunctivitis.~      General objective: assess the safety and efficacy of the PRO-157 ophthalmic solution in~     three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with~     bacterial conjunctivitis.~      Specific objectives:~      determine the safety of the PRO-157 ophthalmic solution in three different dosages versus~     Moxifloxacin versus Gatifloxacin in patients with bacterial conjunctivitis by the incidence~     of adverse events.~      evaluate the efficacy of the PRO-157 ophthalmic solution in three different dosing regimens,~     versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis through~     evaluation of ocular signs and symptoms such as: burning, tearing, foreign body sensation,~     pruritus, photophobia, Conjunctival hyperemia, chemosis, secretion, membranes and / or~     pseudomembranes, scales and eyelid edema, epitheliopathy.~      Number of participants: 300 eyes, 60 per group.~      Inclusion criteria: Patients with bacterial conjunctivitis (signs and / or symptoms and / or~     culture)~      Treatment duration:~      Recruitment: 4 months Treatment: 7 days Follow-up: 15 days~      Criteria for evaluation:~      Measurements of effectiveness: Main efficacy criterion~      It will be determined as effective if there is a reduction in number or species of bacterial~     flora by comparing the basal culture against the final culture among the five different~     patient groups.~      Reduction or absence of infection with the clinical evaluation through signs and symptoms~     such as burning, tearing, foreign body sensation, pruritus, photophobia, conjunctival~     hyperemia, chemosis, secretion, eyelid edema, membranes or pseudomembranes, palpebral scales~     and epitheliopathy~      Safety Measurements: it will be determined by visual acuity and adverse events~      This is a phase II multicenter, evaluating 5 treatment arms. Patients recruited diagnosed~     with bacterial conjunctivitis will be treated for 7 days with any of three doses of PRO-157,~     Moxifloxacin, or Gatifloxacin.~      The randomization will be coordinated by a member of the research team previously designated~     by principal investigator (PI) who will not be masked and will instruct the patients about~     how to apply the drops, emphasizing patients not mention to the evaluating physician about~     frequency of the study medication.~      For protocol purpose, the infected eye (s) will be taken into account at the time of~     baseline, however the study medication and procedures will be applied and performed in both~     eyes to protect the healthy eye.~      The study is divided into the following evaluation periods:~      Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8). and a telephone call (day~     23) for the evaluation of adverse events after 15 days of the last drug application.~      In each visit the PI will take a photograph of both eyes to make a visual clinical~     comparison at the end of the study.~      Subjects will be allocated to any of the following regimen dosages:~        -  PRO-157 1 drop 2 times daily in both eyes~        -  PRO-157 1 drop 3 times daily in both eyes.~        -  PRO-157 1 drop 4 times daily in both eyes.~        -  Moxifloxacin 1 drop 3 times daily in both eyes.~        -  Gatifloxacin 1 drop 3 times daily in both eyes.~      All regimen dosage will have a duration of 7 days. An artificial tear preservative free~     (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during~     study period.~      Data Analysis~      The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) , in which each~     of the variables is described, the ITT population will be constituted by all subjects~     recruited who have received at least one dose of the study, the PP population will be the~     subset of ITT composed of all subjects without any major deviation from the protocol and the~     bivariate analysis will be performed in this group.~      Continuous quantitative variables are expressed and presented by measures of central~     tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and~     ordinal variables are presented by means of frequencies and proportions.~      The Kolmogorov-Smirnov test was performed to know the normal distribution or not of the~     results obtained in each study group.~      The differences between-group were determined by the ANOVA test, for the quantitative~     variables.~      For the qualitative variables, Pearson's chi-square will be used. Intra-group differences~     were analyzed using the T-test in the case of quantitative variables.~      For the qualitative variables differences were calculated by Pearson's chi-square.~      The level of significance was an alpha of 0.05 or less.~   "
5857|NCT02980510|"~     National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus~     mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF~     status from circulating DNA analysis.~      Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.~   "
5858|NCT02980497|"~     The objective of this randomized, single-center, examiner-blind, controlled, parallel group,~     six-month clinical study is to compare the antiplaque/antigingivitis potential of a~     no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing~     mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will~     be included.~   "
5859|NCT02980484|"~     This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial~     magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain~     injury (TBI). Half of patients will receive active treatment, while the other will receive a~     sham treatment with the option of receiving open-label active treatment afterwards.~   "
5863|NCT02980432|"~     The investigators previously shown that a rotating optokinetic stimulus results in shifts of~     the subjective visual vertical in healthy human subjects. However, the origin of these~     shifts is still poorly understood. Both torsional displacement of the eyes and a shift in~     the internal estimate of direction of gravity have been proposed as potential explanations.~     Here the investigators use a vision-independent setup to differentiate between these two~     hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if~     torsion triggers the shift.~   "
5864|NCT02980419|"~     The long-term goal of this research is to advance the investigators knowledge of how the~     brain combines the information of multiple sensory systems coding for spatial oriention and~     how adaptation to vestibular imbalance influences spatial orientation. In healthy human~     subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans~     show a systematic bias in perceived direction towards the previous roll-tilted position~     (so-called post-tilt bias). This effect could either be related to adaptation to the~     roll-tilted position (shifting the null position) or it could be related to changes in~     torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the~     first case a post-tilt bias is predicted independently of the experimental paradigm used,~     the second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In~     order to evaluate these hypotheses, the investigators will assess perceived vertical using~     both vision-dependent and vision-independent paradigms.~   "
5865|NCT02980406|"~     In this study, the investigators aim to assess the effect of acute FODMAP infusion on~     gastric motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers~     and 20 patients with irritable bowel syndrome (IBS) will undergo respectively four and~     two/three pressure measurements of the stomach after an overnight fast as a measure for~     gastric motility. During this pressure measurement, which takes approximately 4 hours, one~     of four FODMAP or control solutions will be administered directly into the stomach through a~     nasogastric tube. Administration will be stopped when the participant is fully satiated. The~     four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a~     fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS~     patients, only the fructan and glucose solution will be tested, where after they can choose~     to come for a third visit to test the fructose solution. The solutions will be tested on~     separate occasions in a randomized order.~      During the pressure measurement, participants will be asked to complete several~     questionnaires: (1) a gastrointestinal symptom questionnaire to assess their~     gastrointestinal symptoms, (2) a satiation questionnaire during infusion of one of the~     solutions, (3) psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible~     psychological effects of FODMAP infusion.~      The investigators hypothesize that there will be differences in gastric motility between~     healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal~     symptoms will be increased in IBS patients, and that FODMAP infusion will have more~     psychological effects in patients than in healthy volunteers.~   "
5866|NCT02980393|"~     This study is to assess whether a lifestyle intervention with diet, exercise and counselling~     in young patients will have a positive influence on their weight and overall well-being.~     This study will enrol patients between the ages of 7 to 17 years of age, who have congenital~     heart disease, and have been identified being overweight or obese. A total of 40 individuals~     will participate in this study. The study duration will last for 1 year.~   "
5867|NCT02980380|"~     Despite partial success, communication has remained impossible for persons suffering from~     complete motor paralysis but intact cognitive and emotional processing, a state called~     complete locked-in state (CLIS).Very recently NIRS was successfully used to investigate the~     functional activations in the cortex of a CLIS patient in response to auditorily presented~     stimuli containing correct or incorrect statements and open questions. The hemodynamic~     change in the motor cortex of the CLIS patient was recorded across many sessions spread over~     more than a year and was used to train a classifier to predict the yes and no answering~     pattern of the CLIS patient who was previously trained to use an electroencephalography~     (EEG) based brain computer interface (BCI) without success. The trained classifier was able~     to provide online feedback (your answer was classified as (in) correct) to the patient~     with performance rate of 71.76%. This is the first carefully documented case of~     communication in a CLIS patient with BCI, which holds promise and raises the hope for~     communication in CLIS. Hence, to further validate the preliminary findings of our lab and~     refine the technology of functional near infrared spectroscopy (fNIRS)-based BCI for~     communication in CLIS-patients extensive studies will be carried out on CLIS patients using~     fNIRS based BCIs.~   "
5868|NCT02980367|"~     The primary objective of this study is to determine in patients with non-acute (greater than~     4 months since injury) Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of~     non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if~     required) is more clinically effective and cost effective than a strategy of surgical~     management [Reconstruction].~   "
5869|NCT02980354|"~     Stroke is a life-threatening medical condition that occurs due to a sudden disruption of~     blood supply to the brain. Although it may affect all age groups including children, the~     elderly are at a greater risk of having strokes. Indeed, three-quarter of all strokes are~     seen in people over the age of 65. Unfortunately, due to short therapeutic window (4.5 h of~     stroke onset), only 2-3% of patients can receive the currently available single medical~     therapy with rt-PA, a clot-busting agent. As recent studies show that bone marrow-derived~     endothelial progenitor cells, a type of stem cells, may migrate to the site of injury to~     repair the damaged brain vessels and tissue, it is possible that their numbers and~     functional capacity may determine the clinical outcome of stroke patients i.e. severely~     disabled, moderately disabled or no signs at all. This study will assess these parameters in~     elderly stroke patients compared to their age-matched stroke-free counterparts and healthy~     young volunteers.~   "
5870|NCT02980341|"~     This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety,~     tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast~     cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines~     a certain type of cancer.~      The number of patients and treatment cycles are not fixed in this study. Subjects who~     continue to derive clinical benefit from the study treatment in the absence of withdrawal of~     consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment~     until the end of the trial.~   "
5873|NCT02980302|"~     According to the World Health Organization (WHO), mental retardation (MR) is defined by an~     intelligence quotient (IQ) < 70 and touches between 1 to 3 % of the general population.~     Profound mental retardation (QI <25), severe (IQ: 25-40) and moderate (QI : 40-50) have a~     prevalence of 0,3-0,5% while the prevalence of mild MR, defined by an IQ between 50 and 70~     is evaluated to about 1,5 %.~      The origin of MR can be infectious, toxic, traumatic, genetic or environmental. genetic~     causes of MR gather the number and structure anomalies of the chromosomes, the genomic~     microreorganization, monogenic diseases and more rarely other non Mendelian-inherited~     anomalies like print or epigenetic anomalies, mutations of the mitochondrial genome etc...~     Genetic causes represents 50% of moderate to severe, whereas environmental factors~     (malnutrition, cultural deprivation,...) plays an important role in mild MR.~      The main goal of this study is to get an innovative tool (neuronal distinction of iPSC) that~     wil allow to study the functionnal impact of mutations uppon genes probably involved in MR~     like MYT1L. The main criteria associated to characterisation of the tool by the trial is the~     study of the pluripotency of iPSC obtained and to highlight the mutation of the gene MYT1L~     in the iPSC.~      Neurons from the iPSC of the patient and his father du patient wille also be morphologically~     characterised, but also thanks to the expression of specifically neurals genes.~      Characteristics of iPSC and neurons from d'iPSC with MYT1L mutation will be compared among~     the patient and his father, in relation with the same cells coming from the two witnesses.~   "
5874|NCT02980289|"~     The study aims to investigate the prevalence and treatment of nausea and/or vomiting in~     patients with advanced cancer not receiving chemotherapy or irradiation.~   "
5875|NCT02980276|"~     The overall objective of the EMERGE trial is to determine whether metformin + usual care,~     compared to placebo + usual care (introduced at the time of initial diagnosis of GDM),~     reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b)~     excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of~     treatment for women with Gestational Diabetes Mellitus.~   "
5876|NCT02980263|"~     The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or~     refractory patients diagnosed with active Kawasaki disease, administration of canakinumab~     controls fever and acute phase reactants.~   "
5877|NCT02980250|"~     The purpose of this clinical multi-center study is to determine whether different doses of~     domperidone are effective in the treatment of feeding intolerance in premature infant~   "
5878|NCT02980237|"~     The objective this study is evaluate if an e-Health education program at the workplace to~     contributes to improve quality of life from Office Workers. And:Life style modification;~     Improve physical activity Reduces on Anthropometric Measures; Reduces Pain and discomfort in~     the musculoskeletal system~   "
5879|NCT02980224|"~     This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the~     treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be~     compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will~     be evaluated for their signs and symptoms of dry eye disease and for safety throughout the~     study.~   "
5880|NCT02980211|"~     PURPOSE The purpose of this case series is to clinically, radiographically and~     histologically evaluate the treatment of dehiscence defects in extraction sockets using a~     minimally-invasive GBR technique that involves the application of a particulate bone~     allograft and a non-resorbable PTFE membrane.~      METHODS Subjects with single-rooted teeth indicated for extraction and interested in future~     implant therapy for tooth replacement will be recruited on the basis of an eligibility~     criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon~     clinical examination in order for the subject to qualify for study inclusion. A cone-beam~     computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be~     obtained prior to tooth extraction. Following minimally invasive tooth extraction and~     debridement, the socket will be evaluated to verify the presence of a dehiscence defect~     affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using~     tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be~     trimmed to a size and shape that would allow for complete extension over the existing defect~     will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be~     grafted with particulate allograft and the access to the socket will be sealed with an~     extension of the membrane and an external cross mattress suture. Subjects will be recalled~     at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual~     analog scale at the end of each visit. At the 5-week visit, the membrane will be gently~     removed and the exposed area will be left to heal by secondary intention. At 20 weeks after~     tooth extraction a second CBCT will be obtained to radiographically evaluate the site for~     implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at~     20 weeks will be made using the CBCT data to assess changes affecting the bone housing. If~     the site has healed adequately, implant placement will be planned at 24 weeks after tooth~     extraction. A bone core biopsy will be obtained at the time of implant placement in order to~     histologically analyze the characteristics of the grafted substrate. Upon implant placement~     with primary stability a healing abutment will be placed and sutures will be given to~     achieve primary wound closure, as necessary. Subjects will return for the final study visit~     at 2 weeks following implant placement to evaluate the healing prior to being referred back~     to the restorative dentist.~   "
5881|NCT02980198|"~     This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα~     antibodies (immune response) in adult subjects with dermatomyositis~   "
5882|NCT02980185|"~     To assess the feasibility, Residual Tumor, complication rate and survival of totally~     laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian~     Cancer, compared with abdominal primary cytoreduction in a single-Institution,~     single-surgeon prospective series.~   "
5883|NCT02980172|"~     All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are~     triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.~     At the end of the triage process the triage nurse has to choose an emergency level and a~     main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a~     pain evaluation for 44 out of the SETS 98 presenting complaint.~      The primary objective of the study is to determine whether pain is correctly evaluated when~     required by the SETS criteria. The secondary objectives are (1) to evaluate whether an~     appropriate treatment is delivered when pain is present, and (2) to identify predictors of~     pain evaluation and treatment.~   "
5884|NCT02980159|"~     Due to an increasing number of patients admitted in emergency departments, many patients~     cannot be evaluated immediately after their admission. The function of triage liaison~     physician was introduced in Spring 2015. The objective of this study is to evaluate the~     impact of this new function on patients' flow in the ED.~   "
5908|NCT02979847|"~     prospective randomized controlled trial~      In repeat procedure for persistent atrial fibrillation, Hybrid group (Epicardial ablation +~     Endocardial ablation) versus control group (conventional Endocardial ablation)~      Freedom from AF/Atrial tachycardia and safety~   "
5909|NCT02979834|"~     This study aims to investigate average gestational week in which mothers feel the~     babies'movements for the first time and maternal-fetal factors affecting this time.~   "
5885|NCT02980146|"~     Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely~     determined by the genetic abnormalities of the tumor cells but also by the host response.~     Indeed, recent studies in CRC have associated improved survival with a high number of~     tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor~     progression and in situ T cell response. Gene expression profiling studies have clearly~     isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC,~     associated with a strong immune response signature involving both Th1/cytotoxic and immune~     evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is~     overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis,~     most likely due to NK and T effector cell functions upon engagement with the inhibitory NK~     receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest~     that if this observation holds true for MSS CRC, HLA-E over-expression is inversely~     associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL,~     depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized~     that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which~     represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non~     conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a~     strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the~     exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the~     HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical~     practice as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that~     could be promising new therapeutic options in CRC patients.~   "
5886|NCT02980133|"~     This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone~     propionate Salmeterol in pediatric patients with a documented history of persistent asthma.~   "
5887|NCT02980120|"~     The proposed study will investigate whether, on the basis of personality traits and~     personality disorders as well as specific cerebral activation patterns shows differences in~     adolescent female with anorexia nervosa (AN), bulimia nervosa (BN) and a healthy control~     group.~   "
5888|NCT02980107|"~     The objective of this study is to evaluate the efficacy of infographics, compared to~     standard PLS format, in presenting information, in terms of understanding and remembering~     research results by consumers.~   "
5889|NCT02980094|"~     The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium~     in the diet of dairy cows on milk composition and the influence of modified milk on~     nutrition and health of elderly. To achieve those goals, two experiments will be conducted,~     both lasting 12 weeks. In the first one, 24 cows at the beginning of lactation will be~     allotted in a completely randomized block design with a 2 x 2 factorial arrangement of~     treatments, as follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3)~     control diet plus sunflower oil diet; 4) control diet plus sunflower oil, selenium and~     vitamin E. This experiment seeks the development of modified milks through nutritional~     manipulation of cow's diet. Concomitantly, in the second experiment, 100 elderly people will~     receive the four different kinds of milk produced in the first experiment in a completely~     randomized block (gender) design. The selection of the elderly for each group shall be~     composed clinical evaluations. Will be conducted biochemical tests before and after~     supplementation of milk consumption (serum α-tocopherol, selenium, analysis of fatty acid~     profile). Assessment of nutritional status will be made body mass index (BMI) with each~     participant before and after the experiment of 12 weeks, including body composition by~     multifrequency bioelectrical impedance analysis (BIA), evaluating the strength of pressure~     of the hand portable dynamometer, demographics and food consumption. The study of human~     nutrition and health will be held in the form of a double-blind study. The second experiment~     aims to study nutrition and health of elderly people, as it is expected that milk produced~     with better fatty acid profile, vitamin and minerals can improve the inflammatory profile of~     markers of the elderly. This project is important for the human population in general,~     particularly elderly people, health workers, human and animal nutritionists, and especially~     for the milk chain, as it has a potential to develop new dairy products and boost milk~     consumption.~   "
5890|NCT02980081|"~     There are only few recognized indications for the realization of plain abdominal X-rays in~     the emergency departement.~      The objective of this study is to explore the reasons for abdominal plain X-rays~     prescription in the Emergency departments (EDs) of two hospitals.~   "
5891|NCT02980068|"~     This is an open-label, single-center study to examine distinguishing features of the~     structure and function of the oral and gut microbiome in healthy adult normal volunteers~     compared to volunteers with PH-HFpEF in the breakdown of oral nitrate.~   "
5892|NCT02980055|"~     The purpose of this study is to analyze the percentage of root coverage in Miller class I~     and II gingival recessions using connective tissue graft and collagen matrix with a two~     years follow-up.~   "
5893|NCT02980042|"~     This is a prospective between and within group observational study to determine differences~     in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS)~     patients who have been administered at least two infusions of rituximab, six months apart~     and are willing to be switched to ocrelizumab compared to a 100 patients who are continuing~     on rituximab as a comparison cohort from the clinic population treated as part of clinical~     care.~   "
5894|NCT02980029|"~     The purpose of this study is to determine if the study drug, TVB-2640, is able to affect~     levels of certain enzymes in subject's blood and cause changes in tumor. This study is only~     for people who require surgery for their colon cancer.~   "
5895|NCT02980016|"~     This study is a parallel, two part, open label, individually randomized, pragmatic trial~     among HIV-positive individuals. Part A compares a single round of weekly high dose~     rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H).~     Part B compares periodic 3HP (p3HP) to a single round of 3HP.~   "
5896|NCT02980003|"~     Intravascular administration of iodinated contrast media is an essential tool for~     cardiovascular imaging and percutaneous coronary interventions. Nonetheless, the increasing~     incidence of contrast-induced nephropathy (CIN) has become an important and prognostically~     relevant problem along with the spreading of diagnostic and interventional procedures. CIN~     is largely dependent on oxidative damage and represents a considerable cause of renal~     failure, being associated with prolonged hospitalization and significant~     morbidity/mortality. The most effective treatment strategy of this serious complication~     remains prevention, and several preventive measures have been extensively investigated in~     the last few years. Pre-procedural hydration is the best known and mostly accepted strategy.~     The administration of sodium bicarbonate (HCO3) has controversial effects, and is likely to~     be ineffective when the infused dose is unable to achieve adequate urine alkalinization.~     Since alkaline pH suppresses the production of free radicals, increasing urine pH would be~     an attractive goal for CIN prevention. In a randomized clinical trial the investigators will~     test the hypothesis that urine alkalinization with either oral or i.v. bicarbonate on top of~     hydration alone is the main determinant of CIN prevention in a population of patients with~     moderate or severe chronic kidney disease scheduled for coronary angiography and/or~     angioplasty. If the investigators, demonstrate non-significant differences in urine~     alkalinization (primary endpoint) and incidence of CIN (secondary endpoint) between the~     bicarbonate groups, a practical implication will be that oral administration is preferable~     for practical reasons over the administration of i.v. bicarbonate.~   "
5910|NCT02979821|"~     In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with~     stage IV lung adenocarcinoma harboring HER2 mutation.~   "
5899|NCT02979964|"~     Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO~     currently conducts audit and feedback as a key quality improvement strategy. For example, it~     offers physicians working in long-term care homes with access to practice reports detailing~     rates of high-risk prescribing in comparison with others in Ontario and suggested change~     ideas. Research shows that providing this kind of feedback can lead to improvements in care.~     However, the size of these improvements depends how the feedback is presented. For instance,~     prior research suggests that how the results are 'framed' and what sort of benchmark the~     recipient is compared to may each affect how the physician will respond. This factorial~     trial tests each of these aspects of feedback design in the context of practice reports that~     nursing home physicians have already signed up to receive quarterly.~   "
5900|NCT02979951|"~     The purpose of this European, multicentric, prospective, non-interventional study is to~     document and evaluate the efficacy and safety of the treatment of severely infected patients~     with intravenously administered fosfomycin, including patients with osteomyelitis,~     complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial~     meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue~     infection, endocarditis or other infections, each as far as covered by the respective~     nationally relevant SmPC.~   "
5901|NCT02979938|"~     In this prospective observational study the investigators will report on 20 male subjects~     with proven WHO-classification Zika infection. These subjects will be followed up for a~     maximum of 12 months to observe the presence, viral load and infectivity of Zika virus~     (ZIKV) in semen over time.~   "
5902|NCT02979925|"~     The proposed study will set the foundation for future multi-center studies. To validate tMS~     as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with~     PTP-NP and improving their overall functions.~   "
5903|NCT02979912|"~     Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous~     platelet lysate.~   "
5904|NCT02979899|"~     This is a study of TRC105 in combination with standard dose pazopanib compared to single~     agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g.,~     metastatic or bulky disease, and disease for which surgical resection would carry an~     unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.~   "
5905|NCT02979886|"~     Gonadotropin-releasing hormone analogue (GnRH-a) long protocol is a protocol for pituitary~     down-regulation in IVF. However, it is common in clinic that some patients are~     hypersensitive to pituitary down-regulation and have pituitary oversuppression, resulting in~     prolonged ovarian stimulation and increased consumption of exogenous gonadotropin(Gn). On~     the other hand, some patients may have insufficient pituitary down-regulation, which can~     affect the synchronization of ovarian follicles and consequently reduce the number of~     oocytes retrievable and lower the pregnancy rate. The differences in responses to GnRH-a~     among patients may be associated with the SNP of their GnRH receptor genes. It has been~     reported that mutations in GnRH receptor genes could change their binding affinity to the~     ligands, thus affecting the outcome of pituitary down-regulation. So far 20 non-synonymous~     mutations on the GnRH receptor genes have been reported, which can affect the function of~     GnRH receptor and are highly associated with disorders such as endometriosis and sexual~     precocity. However, the correlation between the SNP of GnRH receptor genes and the outcome~     of pituitary down-regulation in IVF has not been reported.~      The purpose of this study is to analyze the correlation between single nucleotide~     polymorphism (SNP) of GnRH receptor genes in infertile female patients and the extent of~     pituitary down-regulation by short-acting GnRH-a long protocol, with the goal to achieve~     individual down-regulation protocols based on the patients' SNP haplotypes of GnRH receptor~     genes and to improve the success rate of assisted reproductive technology.~   "
5906|NCT02979873|"~     Background:~      People with severe aplastic anemia (SAA) do not make enough red and white blood cells,~     and/or platelets. Their body s immune system stops the bone marrow from making these cells.~     The treatment cyclosporine leads to better blood counts. But when this treatment is stopped,~     the disease may return in 1 in 3 people. The drug sirolimus may help by suppressing the~     immune system.~      Objective:~      To evaluate and compare the usefulness of sirolimus in preventing aplastic anemia from~     returning after cyclosporine is stopped, compared with stopping cyclosporine alone.~      Eligibility:~      People ages 2 and older with SAA who:~      Have responded to immunosuppressive therapy that includes cyclosporine, and continue to take~     cyclosporine~      Are not taking drugs with hematologic effects~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Bone marrow biopsy: The area above the hipbone will be numbed. A thin needle will remove~      some bone marrow.~      Participants will be randomly assigned to a group. All will stop cyclosporine. Group 1 will~     take sirolimus by mouth at the same time each day for 3 months with close monitoring. Group~     2 will not receive the study drug but will be monitored closely.~      Participants will have clinical tests for the first 3 months:~      Weekly blood test~      Monthly fasting blood test~      For group 1, measurements of sirolimus in the blood every 1 2 weeks~      Participants will have clinic visits at 3 months, 12 months, and annually for 5 years after~     the study starts. They may have another visit if their SAA returns. These will include:~      Blood and urine tests~      Bone marrow biopsy~   "
5907|NCT02979860|"~     Enhancing children's sleep duration and/or timing may represent a novel approach for weight~     regulation and prevention of T2DM. The proposed study will assess how experimental changes~     in children's sleep duration and timing affect weight regulation and T2DM risk. Sixty~     African American children ages 8-11 years old who sleep approximately 9.5 hours or less each~     night will be enrolled into a 4-arm randomized controlled pilot to compare three~     experimental manipulations in children's sleep to a typical sleep (TYP) control.~     Experimental arms will include: 1) increase in time in bed (TIB) by 90 minutes/night; 2)~     increase in TIB by 45 minutes/night; or 3) consistent (CON) sleep schedule (but no change in~     TIB). At baseline, 2- and 4-week follow-up, participants be weighed and measured for height,~     have body fat assessed (bod pod), and their blood drawn (following an overnight fast). The~     pilot will provide important data on the potential role of sleep in combating disparities in~     cardiometabolic risk. Primary aims are: 1) to determine the effects of changes in sleep on~     changes in glucose regulation and 2) to determine the effect of changes in sleep on~     additional measures of glucose regulation and adiposity.~   "
5911|NCT02979808|"~     This study is designed as an open, prospective, non-controlled, qualitative, multicentre~     study of a novel transanal irrigation system performed in a population of 150 subjects~     suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is~     expected to last for a total of 1 year (treatment period) with a planned 12- month~     recruitment period and three scheduled site visits.~   "
5912|NCT02979795|"~     Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading~     cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent~     chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that~     localized radiation not only destroys local tumor but also inhibits the growth of tumor at~     the remote site, has been observed. This effect is believed to be associated with tumor~     immune response. In addition, other immune checkpoint molecules, such as Programmed cell~     death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated~     Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after~     CCRT, more than 50% of patients were still either having persistent disease or developed~     distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this~     project, thus, aims at exploring the evolution of factors that may affect the abscopal~     effect and immune checkpoint functions in tissues and in blood before and after CCRT.~   "
5913|NCT02979782|"~     Primary objectives:~      Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular~     accident (CVA), and delirium after minimal invasive coronary artery bypass grafting~     (Endo-CABG).~      Secondary objectives:~        -  Quality of life, three months after endo-CABG~        -  Patient satisfaction with endo-CABG and the tests performed~        -  The influence of various demographic and peri-operative variables on neurological~          outcome after endo-CABG~        -  Incidence of fear and depression, 3 months after endo-CABG~   "
5914|NCT02979769|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and~     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue~     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict~     movement by locking joints leading to cumulative loss of function and disability. Mouse~     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists~     such as palovarotene (PVO) to prevent HO following injury. This 24-month study will (1)~     continue to follow FOP subjects from France who completed Clementia Study PVO-1A-201; (2)~     enroll up to eight additional new French subjects who have achieved at least 90% skeletal~     maturity; and (3) evaluate the ability of different palovarotene dosing regimens to prevent~     HO in these subjects.~   "
5915|NCT02979756|"~     A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco~     revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in~     receiving appropriate care. Based on the results of the situational analysis, the~     investigators developed this proposal in close collaboration with the Moroccan research~     group on gestational diabetes composed of representatives of the Ministry of Health,~     researchers, members of professional organizations and specialists in the domains of~     endocrinology, gynecology, neonatal health and nutrition. The investigators opted for an~     hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the~     proposed screening and initial management strategy and its implementation at the first level~     of care.~      The objectives of this study are thus to evaluate the feasibility of a decentralized~     strategy of screening for GDM and the initialization of GDM treatment already through the~     primary level of care and to assess its potential for scaling-up. Specific objectives of~     this study are to augment universal access to screening and management of gestational~     diabetes and to increase the competencies of health care providers at first level health~     care facilities to detect, start initial treatment and to improve follow-up of affected~     women. By comparing active screening and treatment initiation through first line health~     facilities with the existing practices, the investigators would like to explore the effect~     of the new model on maternal and newborn outcomes such as weight gain in pregnancy,~     occurrence of delivery complications and birth weight. The investigators will further assess~     the acceptability of screening and initial management of GDM through first line health~     services by health care providers and by pregnant women diagnosed with GDM and the impact of~     two different screening approaches on the lifestyle of affected mothers.~   "
5916|NCT02979743|"~     The aim of this study is to explore the relationship between brain MRI-metrics and hand~     function observed in children with cerebral palsy (CP),compared between baseline and the~     third month, and thus determine the early MRI-based neuroimaging predictor of clinical~     improvement following therapy in children with CP.~   "
5917|NCT02979730|"~     The purpose of the study is to compare Emergency Department patients who undergo influenza~     testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located~     in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who~     agree to participate will have their samples randomly assigned to be tested on either at the~     core lab, or on the POC device. The current turnaround time for samples sent to the~     laboratory is approximately two hours; investigators expect that the point of care device~     can reduce this time. Investigators will determine if the time to disposition and the~     administration of antibiotics is different in the group undergoing POC influenza testing~     compared to those undergoing laboratory-based influenza testing~   "
5918|NCT02979717|"~     The objective of this study is to determine the effect of a high protein, high fiber~     supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high~     carbohydrate Control product in healthy overweight and obese subjects. The investigators~     hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a~     subsequent meal compared to low protein, low fiber.~   "
5919|NCT02979704|"~     This study will be conducted to assess the status of oxidative stress inflammation and~     thrombogenesis in patients with hyperlipidemia and to compare the antioxidative,~     anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.~   "
5920|NCT02979691|"~     Ratiotherapy alone is the current standard treatment for elderly esophageal or~     esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in~     elderly patients. This study aimed to assess the efficiency and safety of simultaneous~     integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT~     followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or~     esophagogastric cancer patients~   "
5921|NCT02979678|"~     The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the~     development of BR-23 published 1996 the standard therapy of breast cancer has changed. New~     therapies brought new side effects and different impact on QoL (quality of life) are not~     sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both~     from clinical and scientific point of view.~   "
32193|NCT02635737|"~     This is a single site, single arm, unblinded safety and feasibility cohort study~     investigating the use of magnetic marker seeds to localise breast tumours.~   "
5922|NCT02979665|"~     anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal~     blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on~     the overall retinal perfusion from these treatments remain to be answered. The purpose of~     the study was to evaluate changes in the retina following anti-VEGF treatment over time,~     using structural and functional diagnostic tests.~   "
5923|NCT02979652|"~     This study is done to estimate prevalence of the main detectable lung and cardiovascular~     complications by an ultrasound realized in room of post-interventional supervision at the~     patients whose duration of general anesthesia is superior at one hour after a surgery to~     risk~   "
5924|NCT02979639|"~     The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'~     HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age.~   "
5925|NCT02979626|"~     The purpose of this study is to determine whether a moderate-severe endpoints (including~     high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary~     complications are predictive of hospitalization, intensive care admission, antibiotic use~     and other complications in children under 8 years of age.~   "
5926|NCT02979613|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate~     (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.~   "
5927|NCT02979600|"~     An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent~     Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing~     patients to regularly increasing doses of allergen. This protocol induces an increase of the~     threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction)~     and a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins.~     The protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut~     proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut~     that can be found in standard product in France.~      The investigators wish to study the evolution of the threshold reactive dose and of the sIgE~     of patients that have followed the OTI protocol. All the needed data are available in the~     medical records so the study will be conducted on retrospective data.~   "
5928|NCT02979587|"~     The purpose of this study is to evaluate the safety and effectiveness of the Harmony TPV~     system.~   "
5929|NCT02979574|"~     The purpose of this study is to compare two types of acupuncture with usual care on treating~     chronic pain. This study has three groups. Two groups will received acupuncture. One group~     will receive usual standard of care for 12 weeks and then will receive acupuncture.~     Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin~     to treat different symptoms and illness, and to promote healing. Each group will undergo a~     different method of needle administration.~   "
5930|NCT02979561|"~     A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa~     or warfarin for prevention of recurrent DVT in patients with angiographically confirmed~     acute massive pulmonary embolism undergoIng endovascular mechanical fragmentation and~     thrombolytic therapy. [RE-SPIRE study]~   "
5931|NCT02979548|"~     The purpose of the study is to find out the efficacy of an anti-emetic drug, Aprepitant as~     an add-on therapy to prevent vomiting in children and adolescents receiving chemotherapy for~     leukemia (AML).~      Children and adolescents admitted with confirmed diagnosis of AML will be assessed for~     eligibility criteria and enrolled in the study. Then they will be divided (randomized) into~     experimental and control groups.~      Experimental group will receive Aprepitant capsules 1 h prior to chemotherapy on days 1-3 in~     addition to ondansetron. Patients will be required to swallow the whole capsule and opening~     of capsule will not be permitted. All three doses will be administered under supervision.~      Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes~     before chemotherapy followed by every 8 hourly for 8 days. Metoclopramide will be used as a~     rescue agent.~      The data will be collected from each patient in a proforma from day 1 to day 13 of~     chemotherapy. A Diary will be maintained for nausea and vomiting record.~      Edmonton's symptom assessment criterion will be used in the diary for assessing severity of~     nausea. The NCI guidelines will be used to assess the severity of vomiting based on the data~     provided by the patient in the diary.~      A modified intention-to-treat population (patients who receive chemotherapy, take one or~     more doses of study drug, and have one or more post treatment measurements) will be used for~     efficacy analysis. Proportion of patients with complete response will be compared between~     patients with or without aprepitant.~   "
5932|NCT02979535|"~     The aim of this study is to investigate the immunogenicity and safety of CYD dengue vaccine~     and Cervarix when administered concomitantly or sequentially in healthy female subjects aged~     9-14 years of age.~      Primary objectives:~        -  To demonstrate that the humoral immune response (in terms of geometric mean titers) to~          Cervarix after concomitant administration is non-inferior to sequential administration~          with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.~        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after~          concomitant administration is non-inferior to sequential administration with Cervarix~          measured 28 days after the last dose of the CYD dengue vaccine.~      Secondary Objectives:~        -  To demonstrate that the humoral immune response (in terms of seroconversion) to~          Cervarix after concomitant administration is non-inferior to sequential administration~          with the CYD dengue vaccine measured 28 days after the last dose of Cervarix~        -  To describe the humoral immune response to Cervarix at baseline and after each dose of~          Cervarix in each and any group~        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after~          each dose of the CYD dengue vaccine, in each and any group~        -  To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in~          each group.~   "
5933|NCT02979522|"~     The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as~     well as recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent~     chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric~     participants with advanced stage newly diagnosed Hodgkin Lymphoma (HL).~   "
5990|NCT02978781|"~     This study is a two-part, multicenter, Phase 2a study to evaluate the efficacy, safety,~     tolerability, and pharmacokinetics of SAGE-217 in up to 80 adult subjects with essential~     tremor.~   "
5934|NCT02979509|"~     All patients will receive standard medical care and no experimental interventions will be~     performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a~     well-established procedure commonly used for the investigation of lesions within or adjacent~     to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal~     gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly~     performed with different size and types of aspiration and core biopsy needles.~   "
5935|NCT02979496|"~     The purpose of this study is to evaluate the effect of daily intake of orange pomace on~     gastrointestinal function as measured by stool frequency. Additional outcomes will include~     aspects of digestive health, diet quality, and fasting blood glucose and lipid~     concentrations. Possible explanations for the mechanism of the pomace will be explored in~     microbial ecology analyses.~   "
5936|NCT02979483|"~     This study assessed the feasibility and effects of an early integrative supportive care~     program in patient with Advanced pancreatic adenocarcinoma (aPDAC).~   "
5937|NCT02979470|"~     The main reason of cancer-related mortality is the spread of cancer cells to distant sites~     (micrometastases). However, only a few small groups of tumor cells can metastasize by~     acquiring mechanism to decrease the immune response. Changes in the systemic inflammatory~     response to the tumor can be measured by blood-based parameters. In particular, the~     proportion of neutrophyls- lymphocytes (NL) has been evaluated for predicting the survival~     of patients with different types of cancer. The first strategy to treat colorectal cancer~     (CCR) is complete resection of the lesion. Nevertheless, some patients experience~     recurrence, probably due to residual micrometastases. We have demonstrated that analysis of~     some resistance proteins (Tyms / MRP1) in circulating tumor cells (CTCs) may predict~     treatment response in metastatic CCR patients (mCRC). We also note that the CTCs kinetics~     can show response to therapy. Patients with stage III disease in the colon / rectum,~     although showing high cure rate, generally fall locally or remotely and studies with blood~     markers in this group of patients is still scarce. Primary Objective: To investigate cells~     found in the blood (lymphocytes and neutrophils and CTCs) to verify if they can help in the~     choice of anti-neoplastic therapy in patients with advanced colon and rectum cancers.~     Secondary objectives: - to evaluate the influence of CTC kinetics in response to treatment~     of patients with advanced colon/rectum cancers; - to check the expression of treatment~     resistance, invasion and proliferation proteins (Tyms, TGF-βR, MMP-2, β-gal, Ki-67 and CD45)~     in CTCs and their correlation with response to treatment; - to check the mRNA expression of~     the same genes observed by immunocytochemistry in CTCs and their correlation with response~     to treatment; - to quantify CTCs, neutrophils and lymphocytes of patients included in this~     study and verify if there are correlation among their rates and progression-free survival.~     Methods: there will be collected 10 ml of blood of patients with advanced colon and rectal~     cancer for analysis of CTCs, lymphocytes / neutrophils. CTCs will be isolated, quantified~     and analyzed after separation by ISET method (Rarecells/France). The marker analysis of~     these cells will be done by immunocytochemistry and the gene expression will be assessed by~     RNAscope. The quantification of lymphocytes/neutrophils will be made by common blood count~     in Delboni laboratory. Expected Results: We propose to show that not only the count and the~     kinetics of CTCs, but also their molecular characteristics, can provide relevant information~     to clinicians. Hopefully, by quantification of neutrophils and lymphocytes, we will be able~     to identify new prognostic blood biomarkers that can direct clinicians to the best~     therapeutic choice.~   "
5938|NCT02979457|"~     The overall aim of the study is to construct a scale that systematically incorporates the~     callers' perspective in a degree of worry - scale and to explore the consequences for the~     actors in the system - caller, call-handler, and health care system.~      This will be done through four independent studies.~        1. Is it possible to validate the degree of worry scale with the software system~          Corti?~        2. Does callers' degree of worry relieve after telephone consultation?~        3. Does call handlers' awareness of degree of worry affect triage outcome?~        4. Is callers' degree of worry a predictor of illness severity?~   "
5939|NCT02979444|"~     There is considerable evidence that most perinatal women at risk for postpartum depression~     do not engage in mental health services, even when referred by home visiting (HV) programs,~     primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be~     delivered via alternative settings—e.g., HV programs—are essential to prevent the onset of~     major depression and worsening of depressive symptoms among perinatal women. This Patient~     Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the~     Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is~     more efficacious than usual care (i.e., home visiting without the MB enhancement). It will~     also examine if MB, when led by paraprofessional home visitors, is not inferior to MB~     delivered by mental health professionals. The results of this study will inform~     decision-making by HV programs regarding provision of MB to perinatal women at risk for~     developing major depression.~   "
5940|NCT02979431|"~     The primary objective is to evaluate the anti-viral effect and safety of different doses of~     inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory~     Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,~     pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different~     doses of inhaled ALX-0171.~   "
5941|NCT02979418|"~     This study will implement the validated household-level water insecurity scale developed by~     study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a~     range of outcomes linked to water insecurity, such as viral load, hydration status, maternal~     depression, stress, food insecurity, and cognitive development.~   "
5942|NCT02979405|"~     Hypotension in patients who are taken to surgery, is a very frequent complication, when the~     spinal anesthetical technique is used, associating this with significant adverse effects~     that can lead to morbidity specially in the obstetric patient. The objective of the study is~     determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance~     of hypotension in obstetric patients led to Caesarea under spinal anesthesia.~   "
5943|NCT02979392|"~     The purpose of this study is to investigate the safety and to determine maximum tolerated~     dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)~     in patients with advanced solid tumor.~   "
5944|NCT02979379|"~     This study is aimed at determining the role of pain in individuals with chronic obstructive~     pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is~     not known whether pain interferes with an individuals performance in PR, or whether PR~     aggravates or relieves pain. Individuals with COPD who report chronic pain and those without~     pain will be enrolled in the study.~   "
5945|NCT02979366|"~     The CL1-64315-001 study is a phase I, international, multicentre, open-label,~     non-randomised, non-comparative study. This study is designed in two parts: one part for~     dose escalation, one part for dose expansion.~   "
5991|NCT02978768|"~     The objective of the present project is to develop complementary and alternative medicine~     (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients~     with Alzheimer Disease, an approach aiming at decreasing the burden on family, society and~     nation.~   "
22411|NCT02763826|"~     The purpose of this study is to determine the optimal transcranial direct current~     stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious~   "
5946|NCT02979353|"~     This randomized, controlled trial will evaluate the effects of an intervention to reduce~     exposure to medications among hospitalized older adults discharged to skilled nursing~     facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as~     defined by dose reductions and stopped medications, based on a combination of clinical~     criteria and patient preferences. The investigators will evaluate the effects of the~     intervention on the total number of medications prescribed to patients at hospital and SNF~     discharge and at home 90-days after SNF discharge along with the prevalence of eight~     geriatric syndromes, medication adherence, and health status.~   "
5947|NCT02979340|"~     Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver~     stiffness and lipid content can be obtained in more than 90% of children and young adults~     with cystic fibrosis.~      Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver~     stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study~     grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular~     (cirrhotic) pattern on ultrasound.~      Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data,~     allow for remote image upload, electronic data storage, and remote image~     viewing/interpretation. This infrastructure will be utilized to standardize image post~     processing.~      Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves~     discrimination of subjects at risk for progression to advanced CF liver disease (development~     of cirrhosis) compared to using US imaging alone~   "
5948|NCT02979327|"~     This study is designed to investigate the cardiovascular response (blood pressure, heart~     rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall~     in healthy adults.~   "
5949|NCT02979314|"~     Corroboratory behavioral evidence showed interaction effects between vestibular stimulation~     and egocentric transformation.~      The investigators here examine in healthy participants, whether there are shared brain~     mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric~     transformation, as well as their interaction.~      It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform~     egocentric mental transformation.~   "
5950|NCT02979301|"~     The study will examine whether changes in background parenchymal uptake (BPU) on molecular~     breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have~     previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen~     for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen~     on BPU.~   "
5951|NCT02979288|"~     In the currently presented trial, investigators aim to evaluate the treatment of the~     intermediate vaginal microbiota during the first trimester of pregnancy with vaginal~     lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD.~     All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days)~     gestational weeks in study group will be treated with vaginal Lactobacilli Capsules~     containing L. Casei rhamnosus LCR 35~   "
5952|NCT02979275|"~     Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there~     might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker~     of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood~     samples during the first post-op day.~   "
5953|NCT02979262|"~     The proposed stage 1 intervention development study is designed to address two significant~     co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner~     violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to~     reduce family violence because SA treatment alone does not result in an end to these~     behaviors. Currently available interventions have had little success in reducing male IPV.~     Fathers for Change, an integrated outpatient intervention, shows promise as an intervention~     model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as~     fathers as a motivation for change and targets factors that are known to trigger SA, IPV and~     CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not~     been integrated and tested as part of a residential substance abuse program for men. This~     project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent~     Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be~     assessed by comparing it to PE in the areas of: participant completion rates, hostile~     cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting).~     Change in hostile cognitions and emotion regulation will be examined as the mechanisms~     through which Fathers for Change reduces relapse, IPV and CM risk behaviors.~   "
5954|NCT02979249|"~     In the medical literature there are conflicting reports on whether iron improves symptoms in~     patients with EPP and XLP. Giving iron to people who are iron deficient is thought to~     improve EPP symptoms. However, this has never been systematically tested. Therefore, the~     purpose of this study is to determine the effect of oral iron for EPP and XLP patients.~   "
5955|NCT02979236|"~     The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS~     Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST~     segment elevation myocardial infarction~   "
5956|NCT02979223|"~     The aim of this study is to compare the efficacy depending on the order of the sequential~     combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with~     ascorbic acid for bowel preparation.~      The investigators designed this study as a phase II prospective randomized parallel arm~     clinical trial. 67 participant will be enrolled in each group (134 in total).~      The primary outcome is the efficacy of bowel preparation. secondary outcomes are~     tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.~   "
5957|NCT02979210|"~     The rationale for the study is to better understand the dynamics of skin microflora~     following skin barrier disruption in an adult dermatitis model. The results from this study~     will provide insights in the complex interaction between skin microbiome and epidermis under~     normal and disease conditions~   "
5992|NCT02978755|"~     First in human study, assessing the safety profile, the pharmacokinetics and preliminary~     antitumor activity of GM102, a new compound (a monoclonal antibody), administered alone in~     patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian~     Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102~     recommended dose.~   "
5958|NCT02979197|"~     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety~     of amlodipine on renal and vascular function in subjects with existing hypertension~     requiring antihypertensive therapy.~      Kitov Pharmaceuticals, Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug~     product (FCDP) consisting of the antihypertensive drug amlodipine besylate and the~     non-steroidal anti-inflammatory drug (NSAID) celecoxib.~      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve~     patient compliance with the once a day (qd) administration of its individual components,~     amlodipine and celecoxib, when used together for the treatment of hypertension, to lower~     blood pressure, in patients who also require the use of an NSAID for relief of the signs and~     symptoms of osteoarthritis. It is also intended to provide prescribers with detailed data on~     how the combination affects the antihypertensive effect of the calcium channel blocker.~      The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a~     single immediate release tablet. However, for this study, two separate capsules will be~     utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo~     capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched~     placebo tablet.~      Kitov recently completed a phase 3 pivotal trial in subjects with newly diagnosed~     hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was~     statistically non-inferior to amlodipine monotherapy with regard to reduction of blood~     pressure. Further, trends towards superior blood pressure lowering effects and improved~     renal function were observed for the combination. This study (KIT-302-03-02) is being~     conducted to quantify the beneficial renovascular effects noted in the prior study in~     subjects with existing hypertension requiring antihypertensive therapy.~   "
5959|NCT02979184|"~     Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a~     decrease in the amount of liquid of the affected limb, with movement of the intracellular~     liquid towards the trunk and the neck then into the jugular-subclavian confluence, the~     superior vena cava and right atrium without modification of extracellular fluid. No study~     have evaluated the prevalence of sleep apnea syndrome in this population and the effect of~     this treatment on sleep apnea syndrome.~   "
5960|NCT02979171|"~     Supraglottic airway tools, one of the tools used in the management of the difficult airway.~     American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom~     airway management algorithms have included the LMA. In our study investigators aimed to~     determine which one will show the best performance with supraglottic airway means that LMA -~     Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios~     created with attaching collar.~   "
5961|NCT02979158|"~     Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an~     increased risk for bleeding.~      Present study aims to compare the platelet function in two patient groups using different~     types of heart-lung machine methods.~      It is assumed that one of the methods is superior verified by sensitive methods of testing~     platelet function.~   "
5962|NCT02979145|"~     The purpose of this study is to develop and validate a clinical outcome measure to evaluate~     disability and disease progression of children 3 years of age and younger (infants and~     toddlers) with various types of Charcot-Marie-Tooth disease (CMT).~   "
5963|NCT02979132|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections and are therefore of limited use in~     populations carrying a high burden of infection and inflammation, as for example women of~     reproductive age in malaria endemic areas in developing countries. Even without the~     confounding effect of inflammation, current markers of iron status are insensitive to small~     changes in dietary iron and do not allow to establish associations between dietary,~     lifestyle and genetic factors and iron balance. With a new method based on the dilution of a~     previously administered and equilibrated stable isotope signal, an accurate measurement of~     long-term oral iron balance and absorption is possible, allowing the estimation of iron~     requirements and potentially providing fundamental guidance for supplementation and~     fortification programs in both healthy and chronically inflamed/infected patients. In the~     current study the novel methodology will be validated in generally healthy subjects with low~     iron status. The technique will be used to assess dietary and lifestyle determinants of iron~     status and to compare the effect on iron balance and iron status of three distinct, commonly~     used iron interventions: food fortification with iron; oral iron supplementation, and~     intravenous iron infusion.~   "
5964|NCT02979119|"~     Rationale:~      Haemophilia is a rare disease; to improve knowledge international collaboration is needed.~     Well-defined clinical data will be collected from complete cohorts in order to prevent~     selection bias.~      Objective:~      To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous~     (treatment-related) determinants of inhibitor development and long term outcome.~   "
5965|NCT02979106|"~     Background: High fructose intake increases blood lactate, triglyceride and uric acid~     concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the~     general population. In patients with hereditary fructose intolerance fructose consumption is~     associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.~      Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance~     (HFI) would have a higher sensitivity to adverse effects of fructose than the general~     population.~      Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls~     received for 7 days a low fructose diet and on the eighth day ingested a test meal~     calculated to provide 25% of basal energy requirement containing labeled fructose (13C~     fructose 0.35 g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation,~     total endogenous glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid~     oxidation, lipids, uric acid, lactate, creatinine, urea and amino acids were monitored for 6~     hours.~   "
5966|NCT02979093|"~     A prior study by the principal investigator of this project identified dopamine- and~     oxytocin-related brain pathways that showed a diminished response when addicted mothers~     viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These~     areas include the hypothalamus, striatum and ventromedial prefrontal cortex. Oxytocin, a~     neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in~     maternal brain and behavioral responses. When administered intranasally, the pilot data has~     shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.~      The purpose of this study is to continue and expand upon the previous investigation of~     maternal addiction, by conducting a randomized, double-blinded, placebo controlled,~     crossover study of intranasal oxytocin on maternal brain responses. 150 mothers from the~     University of Iowa and the Yale Child Study Center will be enrolled (75 with a history of~     drug addiction and 75 matched control mothers), along with their 2 to 12-month-old infants,~     to participate in four study visits over a two-month period.~   "
6015|NCT02978456|"~     The purpose of this study is to compare clinical outcomes between quantitative coronary~     angiography -guided and Intravascular ultrasound -guided strategy in patients with~     significant coronary artery disease undergoing Drug eluting stent implantation.~   "
5967|NCT02979080|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a~     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of~     iron intervention difficult. A potential reference method to quantify iron absorption and~     requirements using isotope dilution measurements in women living in areas with high burden~     of infection should be developed and validated within this project. The new method will~     allow accurate measurement of long term oral iron absorption and the estimation of iron~     requirements, potentially providing fundamental guidance for supplementation and~     fortification programs in sub-Saharan Africa. In a case series with four months'~     preventative iron supplementation intervention imbedded between a four months' control~     period prior intervention and a four months' control period after intervention, we will~     follow a group of 63 women. During the intervention period, the women will receive 50 mg Fe~     as ferrous sulfate tablets every day for 120 d. In total, the women will give 9 blood~     samples (day 1, 60 120, 150, 180, 210, 240, 300 and 360) for the de-termination of the~     isotopic composition and iron status biomarkers and 5 stool samples (day 1, 120, 180, 240~     and 360) for the detection of soil transmitted helminths and gut inflammation. This design~     will allow the measurement of the isotopic iron dilution to assess the total oral iron~     absorption during the intervention period in comparison with the control periods without the~     administration of additional iron isotopes.~   "
5968|NCT02979067|"~     Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid~     Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.~   "
5969|NCT02979054|"~     The purpose of this study is to assess the performance and safety of T4020 versus saline~     solution.~   "
5970|NCT02979041|"~     The aim of the proposed study is to investigate the effectiveness of an interactive, virtual~     reality (VR) training program for pilots compared with standard care. The study will be a~     randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups:~     standard physiotherapy and medical care vs standard care and VR training. Outcome measures~     will include subjective scores of pain intensity and global perceived effect; objective~     measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional~     measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and~     between groups analyses.~   "
5971|NCT02979028|"~     This is a single center, randomized, double-blinded, controlled clinical trial. The purpose~     of this study is to to determine whether treating by transcutaneous electrical acupoint~     stimulation (TEAS) during perioperative could alleviate the postoperative complications in~     patients undergoing artificial joint replacement surgery.~   "
5972|NCT02979015|"~     Primary Objective:~      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese~     healthy subjects.~      Secondary Objectives:~        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.~        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density~          lipoprotein cholesterol (LDL-C) and other lipid parameters.~        -  To assess the immunogenicity of a single SC dose of alirocumab.~   "
5973|NCT02979002|"~     The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a~     composite reference standard test (Direct examination of skin smears + PCR test) in patients~     with clinically suspected Cutaneous Leishmaniasis disease in Morocco.~   "
5974|NCT02978989|"~     To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is~     defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing~     consecutive non-solo procedures conducted by a surgeon in the presence or absence of human~     assistant(s).~   "
5975|NCT02978976|"~     The aim of this study is to determine the effect of administering antenatal steroids in term~     fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings~     with clinical data obtained after birth documenting respiratory disorders.~   "
5976|NCT02978963|"~     This case series aims to test the feasibility and acceptability of streamlined cognitive~     behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol~     focuses on reducing intolerance of uncertainty and the hypothesis is that this will help~     reduce worry.~   "
5977|NCT02978950|"~     This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma~     surgery service at Intermountain Medical Center who are deemed to be at high risk for venous~     thromboembolism. Once identified and enrolled, subjects will be randomized to receive~     bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study~     will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and~     major bleeding episode rates, both during the index hospitalization and at 90 days~     post-discharge.~   "
5978|NCT02978937|"~     This is an observational study involving chart review of patients seen in the bariatric~     clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into~     two groups according to their metabolic profile (healthy vs unhealthy). The assignment to~     each group will be determined by the presence of diagnosis of hypertension, diabetes~     mellitus and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as~     metabolically unhealthy. Then, each group will be divided based on the presence of~     Obstructive Sleep Apnea diagnosis. All data will be collected through a review of the~     patient's electronic medical record from the bariatric clinic database (the investigators~     will collect variables as age, gender, race, BMI, smoking status, the presence of diagnosis~     as Obstructive sleep apnea, hypertension, diabetes, hyperlipidemia). The investigators will~     analyze that data and establish if there is any correlation between sleep apnea and the~     subjects' metabolic profile.~   "
5979|NCT02978924|"~     To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The~     investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore~     both motor and sensory pathways of the spinal cord leading to functional improvements.~   "
6003|NCT02978612|"~     This is a phase 2, randomized study where the aim of the study is to investigate the~     tolerance of adjuvant chemotherapy, measured by functional decline, after surgery for colon~     cancer stage III in elderly patients. Secondary aims are disease-free survival, toxicity,~     late functional outcome, quality of life, to establish a geriatric assessment for selection~     of patients, and to examine the prognostic value of gene signature tests / biomarkers for~     stage III colon cancer.~   "
5980|NCT02978911|"~     Introduction: The skull base tumors surgery remains a challenge since numerous cranial~     nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed~     with the tractography following white fibers and visualizing functional tracts. Cranial~     nerves tractography could allow predicting their displacement by skull base tumors that may~     help the surgeon to spare them along the surgery.~      Methods: Preoperative cerebral MRI was performed on patients who presented with skull base~     tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32~     directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128,~     b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was~     corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically~     tracked with Mrtrix3. Cranial nerves were selected according to their location around the~     tumor. The radiological expected position of the cranial nerve was compared to its~     operative real position.~   "
5981|NCT02978898|"~     Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its~     signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of~     lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that~     modulates the signaling of several TLRs, but only limited studies have evaluated its~     expression by flow cytometry (FCM) in LPD.~      Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean~     fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained~     from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia~     (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL,~     n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.~   "
5982|NCT02978885|"~     The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission~     computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.~     The investigators will study patients undergoing major surgery, specifically Whipple~     procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and~     after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.~   "
5983|NCT02978872|"~     The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole~     blood coagulation analysis. This study compares Quantra measurements determined in arterial~     versus venous blood samples obtained from patients undergoing cardiac surgery.~   "
5984|NCT02978859|"~     Primary Objective:~        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating~          the progression free rate at 12 weeks as compared historical controls.~      Secondary Objectives:~        -  To further evaluate the safety profile of MGCD516 by assessing adverse event rates~          (according to National Cancer Institute CTCAE version 4.0 criteria) in patients treated~          with this agent.~        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating~          the overall response rate (according to RECIST 1.1 criteria), progression free survival~          and overall survival in patients treated with this agent.~   "
5985|NCT02978846|"~     This study is asking patients who are undergoing radiation therapy with or without~     chemotherapy on how well they evaluate their side effects on the last day of treatment. This~     study is not to change health outcomes of the patients in this study. Asking patients to~     rank side effects in order of which ones bother them the most may help researchers identify~     the most troubling side effects of cancer treatment.~   "
5986|NCT02978833|"~     Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain~     Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by~     side lying, stair climbing, and walking. Treatment is currently limited to lifestyle~     modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical~     repair. Platelet rich plasma (PRP) injections contain important growth factors that are~     essential in the healing and tissue formation processes. However, the extent to which PRP is~     more efficacious than whole blood in tendinopathy remains unclear. In this double-blind~     randomized trial, patients will be allocated to receive either a PRP or whole-blood~     injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,~     and 1 year.~   "
5987|NCT02978820|"~     Scoliosis specific exercises have been shown to improve curve progression but there have~     been few studies that compare the different exercise approaches in adolescent idiopathic~     scoliosis (AIS). The objective of this study was to compare the effects of Core~     stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS~     exercises) in addition to brace wearing in patients with AIS. It is important to compare~     different exercise methods on different aspects of scoliotic deformity, such as curve~     progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction~     with treatment and quality of life.~   "
5988|NCT02978807|"~     The objective of this study is to determine the most appropriate and effective approach for~     the diagnosis of gestational diabetes mellitus (GDM) among pregnant women receiving focused~     antenatal care at Moi Teaching and Referral Hospital (MTRH). This will be done through~     performing a random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and~     HbA1c on all participants who meet eligibility criteria and provide written, informed~     consent. The specific research question is: what is the most appropriate screening and~     diagnostic strategy for patients receiving antenatal care at MTRH?~   "
5989|NCT02978794|"~     With the extension of the average life expectancy, the incidence of cardiovascular diseases~     is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but~     also in countries around the world), stroke and the impact of socio-economic and health~     spending are large how to reduce the degree of disability after stroke is an important issue~     in medicine. For a long time, the resident will fill the clinical pathway form before the~     stroke inpatients were discharged. We also analyzed the data of clinical pathway every three~     months.~      According to the current data of stroke clinical pathway included demographic data, length~     of hospitalization days, complications, functional independent measure, Brunnstrom motor~     recovery stage, mini-mental state examination, geriatric depression scale, blood pressure~     data, and post-stroke checklist for a retrospective analysis to provide more complete and~     more comprehensive information on follow-up care for stroke patients and effective use of~     medical resources, to improve the quality of future medical care and quality of life for~     stroke patients.~   "
36998|NCT02572752|"~     To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib~     compared to 2 soft gelatine capsules containing 100 mg nintedanib~   "
5993|NCT02978742|"~     Bulimia nervosa and binge eating disorder pose a public health concern due to their high~     co-occurrence with other psychiatric disorders and poor physical health outcomes. It is~     therefore concerning that less than half of these patients seek treatment for their~     condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms~     to family members. Even for those who do wish to seek help, treatment is often inaccessible~     due to the geographic centralization of eating disorder specialists and a low ratio of~     specialists to patients. Therefore, the aim of this study is to test a potential solution to~     these problems and make eating disorder care more private and accessible.~      One possible way to improve the accessibility of treatment is through smartphone~     applications (or apps). We are testing an app called Recovery Record, which is primarily a~     tool used to self-monitor eating habits, where patients record their meals and related~     thoughts, feelings, emotions, and behaviours (e.g., binge eating/purging). The app also~     offers additional features such as discrete reminders to log meals, positive reinforcement,~     social support, coping strategy suggestions, and linking users with clinicians for real-time~     feedback and suggestions. The application is scientifically supported and has been tested~     with positive results.~      Recently, app developers have created a computer-automated 8-week treatment program that~     uses the patient's data to provide a tailored and individualized treatment program. This~     program aims to mimic the process of therapy by checking in with users, reminding them of~     their reasons for wanting to recover, and working towards goals. We will be testing this~     automated app treatment program, comparing it both with and without input from a trained~     coach providing individualized feedback to users.~   "
5994|NCT02978729|"~     The purpose of this study is to compare two methods for remote genetic counseling (telephone~     and two-way videoconferencing) for patients who are receiving disclosure of their APOE~     (apolipoprotein E) genotype. The target population will consist of males and females in the~     age range of 60-75 years who, as potential participants in a study (Generation Study), will~     need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing~     to receive genetic counseling and disclosure remotely. Subjects must be willing to be~     randomized to either telephone arm or videoconference arm.~   "
5995|NCT02978716|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients~     with metastatic triple negative breast cancer.~      The study is open-label and approximately 90 patients will be randomly assigned (1:1:1~     fashion) to 1 of the 3 following treatment groups:~        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)~        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day~          cycles (n=30)~        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of~          21-day cycles (n=30)~      The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival~     Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment~     and completes at the Post-Treatment Visit.~   "
5996|NCT02978703|"~     Observational study for the evaluation of clinical effectiveness in daily clinical practice~     of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg -~     Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic~     Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal~     (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms~     despite regular bronchodilator therapy in Greece.~   "
5997|NCT02978690|"~     This is a phase I, open label, single group study that is being performed to assess the~     safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a~     single dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).~   "
5998|NCT02978677|"~     The trial evaluates the effect of a moderately increased radiation dose in patients with~     atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery.~     Endpoint is recurrence-free survival after 5 years.~   "
5999|NCT02978664|"~     The investigators will review video-recordings of three randomized, controlled trials~     (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water~     exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi~     Hospital.~   "
6000|NCT02978651|"~     The first objective of this study is to demonstrate the efficacy and safety of pitolisant~     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,~     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea~     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by~     nCPAP but still complaining of EDS.~      The secondary objectives of the study include assessing the long-term tolerance as well as~     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks~     of Open Label Extension period.~   "
6001|NCT02978638|"~     This study aims to improve continence of patients with spinal cord injury using electrical~     stimulation.~      The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving~     bladder and bowel function in patients with spinal cord injury (SCI). It has been~     commercially available in Britain and other countries since 1982, and has been used in~     thousands of patients with SCI to improve bladder, bowel and sexual function. It received~     FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing~     urination on demand and to aid in bowel evacuation.~      Electrical stimulation to produce bladder contraction and improve bladder voiding after~     spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex~     contraction of the bladder, which improves continence. However, cutting these nerves has~     undesirable side effects. This study will not cut any sensory nerve. This study is testing~     the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves~     to improve continence after spinal cord injury.~   "
6002|NCT02978625|"~     This phase II trial studies how well talimogene laherparepvec works and nivolumab in~     treating patients with lymphomas that do not responded to treatment or non-melanoma skin~     cancers that have spread to other places in the body or do not responded to treatment.~     Biological therapies, such as talimogene laherparepvec, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop tumor~     cells from growing. Monoclonal antibodies, such as nivolumab, may block a protein needed by~     tumor cells to grow and spread. Giving talimogene laherparepvec and nivolumab may work~     better in treating patients with lymphomas or non-melanoma skin cancers.~   "
6008|NCT02978547|"~     This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable~     PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of~     7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at~     baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented~     to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before~     surgery.~      At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens~     will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation~     marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases~     3, 8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western~     blot analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq~     analysis. Pre-metformin biopsy samples will be retrieved for molecular analysis.~      Fasting blood samples at baseline and before surgery will be analyzed for glucose and~     insulin levels. Plasma and whole blood will also be processed and banked for circulating~     tumour DNA analysis. Urine samples will be sent for metabolomic profiling.~   "
6009|NCT02978534|"~     The widespread and common use of quetiapine in childbearing and pregnant women demands more~     data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation~     Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior~     A, B, C, D, and X categories. Additionally, the PLLR will require information to aid~     prescribing decisions in three categories 1) Pregnancy (including labor and delivery), 2)~     Lactation, and 3) Females and Males of Reproductive Potential. The pregnancy category will~     include a subsection that will describe pharmacokinetic and pharmacodynamic characteristics~     of the medication in pregnancy, fetal risk, and data quality. The data collected in this~     study will update the FDA pregnancy pharmacokinetic section for quetiapine and inform~     physicians that prescribe to childbearing women.~   "
6010|NCT02978521|"~     Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading~     cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with~     LC affecting up to 80% of patients with advanced stage disease, and it has been related with~     higher risk of complications, length of hospital stay, and worst overall survival. During~     cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass~     has been associated to higher treatment related toxicity, loss of functional status, shorter~     progression free survival and overall survival in different types of cancer under various~     treatments. Hence, preservation of muscle mass and function should be an important focus of~     the multidisciplinary treatment of patients with LC.~      Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue~     and improve exercise tolerance in patients with LC undergoing curative surgery. However, few~     studies have focused on the efficacy of PR on patients with advanced cancer undergoing~     palliative care with chemotherapy or targeted therapies.~   "
6011|NCT02978508|"~     This is a multi-center, double-blind, randomized, two arm parallel design study. This study~     is comprised of two phases: screening and treatment. The screening period will be up to 5~     days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will~     be randomized to receive either test or reference treatments in a double-blind manner in an~     outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and~     reference drug arms and will be stratified by site.~      Screening will begin at visit 1, during which eligibility will be determined and prohibited~     treatments will be discontinued. Randomization will occur following the confirmation of the~     eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The~     treatment phase will be 28±4 days in duration wherein subject will receive treatment with~     investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety~     and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and~     tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day~     28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the~     subject will be retreated with the second application of the investigational product.~   "
6012|NCT02978495|"~     Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to~     15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast~     cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of~     target therapies to date, there is no consensus regarding the most effective treatment for~     this subgroup of tumors. Although evidence shows that triple negative breast cancer is~     highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence~     to support the hypothesis that patients with triple negative breast cancer and mutation in~     BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator~     proposes a prospective, randomized, open-label, phase II study, evaluating the rate of~     complete pathologic response, disease-free survival, overall survival and prognostic~     evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer~     submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or~     without carboplatin.~   "
6013|NCT02978482|"~     A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability,~     Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with~     tremelimumab in Chinese Patients with Advanced Malignancies~   "
6014|NCT02978469|"~     Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for~     morbidity and mortality.~      People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to~     lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where~     found to be inactive most of the day thus, they are in greater risk of disease than the~     general population. In addition, over the years, people with disabilities experience~     physical and functional deterioration. Reducing sedentary behavior and increasing daily~     activity can reduce health risk factors among the adolescents with CP, reduce secondary~     impairments and preserve function.~      Interventions that included exercise alone has not resulted in physical activity and~     participating in a structured training did not continue after cessation intervention.~      The objectives of this study are to establish effective programs aiming to promote an active~     life style among adolescents and young adults with CP and to evaluate there outcomes.~      Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary~     behaviors and increasing physical activity among adolescents and young adults with CP. As~     well as, identifying mediators, needs and preferences for reducing sedentary behaviors and~     increasing physical activity among adolescents and young adults with CP.~      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and~     increasing physical activity among adolescents.~      Stage 3- translating and developing questioners for the study.~        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and~          validating the Hebrew translation.~        -  Developing a self-efficacy perception questioner for increasing physical activity and~          reducing and sedentary behavior.~        -  Translating to Hebrew, adjusting and validating an activity diary.~      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing~     sedentary behaviors and increasing physical activity among adolescents and young adults with~     CP.~   "
7257|NCT02962232|"~     To evaluate the safety and efficacy of the paclitaxel-eluting peripheral balloon dilatation~     catheter (LEGFLOW) compare to the PTA catheter (AMPHIRION DEEP).in treatment of inferior~     genicular artery stenosis or occlusion.~   "
6016|NCT02978443|"~     Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous~     melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab~     followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma~     for histopathology review and immunohistochemistry analysis at Georgetown~     University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored~     in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each~     participating institution. At the end of participation, samples will be sent to Georgetown~     University-Lombardi Comprehensive Cancer Center for processing and storage. An optional~     pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled~     patients. Patients will receive nivolumab in combination with ipilimumab according to the~     standard FDA approved treatment regimen.~   "
6017|NCT02978430|"~     The aim of this study is to compare the implementation of computer-assisted goal directed~     fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.~   "
6018|NCT02978417|"~     In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol®~     effectiveness in drug courts, investigators propose a feasibility study in the Wake County,~     North Carolina drug court, where an estimated 50% of clients are opioid dependent.~      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and~     eligible clients of the Wake County Drug Court.~   "
6019|NCT02978404|"~     Stereotactic radiosurgery (SRS) is increasingly administered as the sole treatment of brain~     metastases, in order to spare acute and long term side effects associated with whole brain~     radiotherapy. Local control of SRS treated lesions is good, but patients tend to develop~     additional brain metastases subsequently.~      Nivolumab is a modulator of the immune system. Treatment with Nivolumab is associated with~     an increase in local control and survival in patients with non-small cell lung cancer and~     clear cell renal cell carcinoma. In the presence of Nivolumab, treatment of brain metastases~     with SRS may trigger an immune reaction against cancer. Therefore, the combination of SRS~     with Nivolumab may reduce the development of new brain metastases and improve patient~     survival.~      The purpose of this study is to assess the effect of combining Nivolumab and SRS in~     controlling cancer progression. SRS will be administered to patients while they are~     receiving Nivolumab.~   "
6020|NCT02978391|"~     UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic~     treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.~      Several endoscopic hemostasis methods are currently in use. UI-EWD (Endoscopic Wound~     Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect~     and safety in endoscopic application will be verified. This study has been designed to~     observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic~     hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.~   "
6021|NCT02978378|"~     The investigators objective is to assess the utility of renal biomarkers in predicting renal~     recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation~     (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal~     function and the likelihood of renal recovery in patients having cardiogenic shock and~     requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output~     and serum Creatinine level) do not accurately represent renal function.~   "
6022|NCT02978365|"~     Case control study to evaluate different factors (e.g muscle strength, psychological~     factors) that are associated with full recovery and functional status 6 months after~     surgical repair of shoulder instability.~   "
6023|NCT02978352|"~     Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced~     attention, impaired cognition and perception, usually resulting from general physical~     conditions. Delirium contributes to longer hospital length of stay, increased mortality,~     increased healthcare costs, and long-term cognitive and functional impairment. However, it~     is often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a~     time-efficient, flexible and convenient training method, making it suitable for a large~     organization like Siriraj hospital where there is a large employee turnover rate. So the~     investigators want to compare the passing rate between the e-learning group and the~     traditional learning group.~   "
6024|NCT02978339|"~     The purpose of this study is to determine whether curcumin, a drug and naturally-occurring~     plant compound, is safe and effective in the treatment of primary sclerosing cholangitis~     (PSC).~   "
6025|NCT02978326|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety and pharmacokinetics of SAGE-217 in up to 32 adult female subjects~     diagnosed with severe postpartum depression.~   "
6026|NCT02978313|"~     Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction~     treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive~     metastatic colorectal cancer after first line induction treatment for 24 weeks with~     mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of~     progression.~   "
6027|NCT02978300|"~     Acute respiratory failure is the leading cause of ICU admission of immunocompromized~     patients. In this subgroup of patients, the need for intubation and invasive mechanical~     ventilation occurs in about 50% of cases and is associated with very a high mortality rate,~     reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to~     avoid intubation.~      More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and~     mortality rates of immunocompromized patients as compared to standard oxygen through a mask.~     However these results have not been confirmed in a recent large trial.~      HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone~     could decrease mortality and intubation rates in patients with ARF as compared to NIV.~     Similar findings have been reported in a post-hoc analysis on immunocompromized patients~     excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of~     immunocompromized patients, we reported better outcomes with HFNC than with NIV.~   "
6028|NCT02978287|"~     The aim of this study is to measure of the parathyroid cell viability and the the amount of~     calcium sensing receptor of the parathyroid cells which were placed into a new~     transportation solution (BAVU solution) for parathyroid allotransplantation.~   "
6029|NCT02978274|"~     Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK~     cells phenotype and functional reconstitution.~   "
6030|NCT02978261|"~     This phase I, open-label, dose-escalation study was conducted to determine the maximum~     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),~     pharmacokinetics (PK) profile, and preliminary antitumor activity of single and multiple~     doses of PLB1001 in Patients with PTPRZ1-MET fusion gene positive recurrent high-grade~     Gliomas.~   "
6031|NCT02978248|"~     ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.~      The study design includes three study arms:~        1. ARENA Intervention: This project will examine the effectiveness of population~          education.~        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether~          there are any complications.~        3. ARENA Migration: ARENA migration aims to examine whether a targeted population~          education can improve the care of people with a Turkish migration background.~   "
6032|NCT02978235|"~     The Phase 1 portion of this study will determine the safety of TAS4464 and the most~     appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the~     study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma~     or Lymphoma~   "
6033|NCT02978222|"~     This is a blinded, randomized, parallel groups Phase II trial. Patients with platinum~     sensitive ovarian cancer (defined as time to progression > 6 months in the penultimate~     platinum containing regimen) and who had either a tumor response or a stable disease upon~     completing their last platinum containing regimen will be randomized to either vaccine~     regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be~     administered as a consolidation therapy within 8 weeks of last platinum administration.~      The vaccination phase will include 6 administrations of the study drug at 4-week intervals.~     After vaccination, patients will be monitored for tumor response (if measurable tumor was~     present at baseline) and for relapse or progression during an 18-month follow-up after~     completion of vaccine treatment.~      The total duration of the study will be 2 years. Assessment for tumor response, disease~     progression and recurrence will be conducted every 12 weeks from the end of treatment until~     documented disease progression.~   "
6034|NCT02978209|"~     A randomized double blinded clinical trial will be conducted comparing the effect of three~     simple basic moisturizers only different in the concentration of carbamide (urea). Three~     concentrations of carbamide will be tested, 5, 7.5, and 10 %, respectively. The study will~     be conducted as a split-body-study and will contain three arms randomized to comparing 5 and~     7.5 %, 5 and 10 %, and 7.5 and 10 % carbamide, respectively. 20-30 patients with at least~     clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of~     the moisturizers will be assessed by clinical examination (score), patients assesment of~     effect and measurement of transepidermal water loss (TEWL) and other skin parameters.~   "
6035|NCT02978196|"~     To evaluate the efficacy and safety of 99m-Tc labeled anti-PD-L1 VHH for SPECT/CT diagnostic~     imaging of Non-Small Cell Lung Cancer and compare it with the existing gold standard biopsy~     PD-L1 detection. It is also to establish a new method of clinical diagnosis of NSCLC using~     99m-Tc labeled anti-PD-L1 VHH.~   "
6036|NCT02978183|"~     The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to~     placebo for the treatment of the signs and symptoms of allergic conjunctivitis.~   "
6037|NCT02978170|"~     The goal of this clinical research study is to find out if adding a Cone-Beam CT (CBCT) scan~     during a scheduled bronchoscopy can help researchers biopsy lung lesions that are harder to~     reach.~      CBCT is a newer type of CT scan that researchers will use to make sure the tools used to~     biopsy these lesions (called a bronchoscope and a radial probe-EBUS [RP-EBUS]) are in the~     right location. The safety and feasibility of adding this extra scan to a standard~     bronchoscopy will also be studied.~   "
6038|NCT02978157|"~     From the profiles of antibiotic susceptibility data following eradication therapy,~     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in~     the rescue treatment.~   "
6039|NCT02978144|"~     This will be a prospective study examining the use of 99mTc-Annexin V-128 (AxV-128/Tc)~     single-photon emission computed tomography (SPECT)/computerized tomography (CT) technology~     in the imaging and functional assessment of the lung of patients with chronic obstructive~     pulmonary disease (COPD), healthy volunteer smokers without COPD and healthy volunteer~     subjects without smoking history. The aim of study is to determine if patients with COPD~     have an increased AxV-128/Tc signal with SPECT/CT.~   "
6040|NCT02978131|"~     Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world~     population is infected with Mycobacterium tuberculosis. There is an increase in the number~     of cases of classic tuberculosis in developing countries, even if number of cases are~     declining in developed countries. However, in developed countries this decrease is~     counterbalanced by the emergence of multidrug resistant (MDR) strains of the bacteria.~      There are also latent forms (1/3 of the world population) of the infection that can be~     reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis~     and 9 million new cases are identified, including about 500,000 cases of MDR TB.~      The spread of this disease as well as the increasing number of cases of MDR tuberculosis,~     reinforce the need for research and development of strategies of diagnosis and management of~     this affection.~      Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at~     least three weeks to be performed. The objective of this study is to evaluate the~     sensitivity and specificity of histopathological and molecular techniques (PCR) on~     paraformaldehyde fixed and embedded in paraffin tissues for a faster diagnosis of~     tuberculosis in current practice, in order to administrate an efficient treatment as soon as~     possible.~   "
6041|NCT02978118|"~     This pilot study purpose of this study is to describe peripheral circulating immune cell~     profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell~     carcinoma and urothelial carcinoma.~   "
6042|NCT02978105|"~     The investigators hypothesized that hypnosis is an alternative technique that could be~     applied to help patients with obesity to lose weight.~      The possibility that a self-conditioning technique (self-hypnosis) added to traditional~     approach (diet, exercise and behavioral recommendations) will be effective in determining~     weight loss with respect to the traditional approach in subjects with a body mass index~     (BMI) between 35 and 50 kg/m2 will be studied.~   "
7580|NCT02957994|"~     To evaluate various markers of renal function and bone density after the switch to Tenofovir~     alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with~     Tenofovir disoproxil fumarate (TDF) .~   "
6043|NCT02977390|"~     This is a pilot study to investigate whether patients at advanced age are fluid responders~     via a reversible fluid challenge, the passive leg raise test. This will be measured with a~     non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .~   "
6044|NCT02977377|"~     To investigate the effects of whole body vibration on postural control and on the level of~     satisfaction regarding how to reach the goals of the patients with ataxia~   "
6045|NCT02977364|"~     To investigate safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241~     in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive~     treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity~     (DLT) and the maximum tolerated dose (MTD) of HS-10241 in advanced cancer patients. At the~     same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 will be~     observed in advanced cancer patients. To determine the recommended dosage regimen for phase~     II.~   "
6046|NCT02977351|"~     Determine the relationship between the systemic indications of atherosclerosis by means of~     the change in the ratio of periodontopathogenic microorganisms following periodontal~     treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis~     and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.~   "
6047|NCT02978092|"~     Retrospective, analysis of three different methods to measure patients' pupil diameters~   "
6048|NCT02978079|"~     Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye~     and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the~     sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of~     the etiologies for ischemic stroke in young patients.~      In our current study, we will explore the diagnostic accuracy of automated binocular~     pupillometry in the diagnosis or HS, and its potential in identifying dissection of the~     carotid artery in patients of young age who suffer ischemic stroke.~   "
6049|NCT02978066|"~     Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac~     Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was~     defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations~     between hypotension and the hemodynamic changes after preanaesthetic fluid loading and~     spinal anesthesia were analysed by logistic regression analyses.~   "
6050|NCT02978053|"~     This project examines 1) the effects of appropriately timed bright light on adaptation (in~     terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such~     bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule~     after the night shift period.~   "
6051|NCT02978040|"~     Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients~     with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time~     of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to~     tirofiban and to chewed or integer loading dose of prasugrel is unknown.~      The purpose of this trial is to assess the inhibition of platelet aggregation with different~     regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion,~     prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary~     PCI.~   "
6052|NCT02978027|"~     The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels.~     More than 50% of alcohol health consequences occur in risky, non-dependent drinkers.~     Increasing the efficacy and efficiency of brief interventions in medical setting could~     significantly reduce the public health impacts of risky drinking. There is intense interest~     in conducting motivational interviewing (MI) informed brief interventions for risky alcohol~     use in medical settings, but little empirical information is available regarding which MI~     behavioral and interpersonal style components drive effectiveness. The field would benefit~     greatly from empirically-based Stage 1 treatment development and modeling studies to~     delineate the degree to which adding motivational interviewing components to brief~     intervention improves outcome.~   "
6053|NCT02978014|"~     A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy~     in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare~     (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.~   "
6054|NCT02978001|"~     The pathophysiological mechanisms explaining the association between psoriasis and type 2~     diabetes are largely unknown but it has been hypothesized that systemic inflammation found~     in both psoriasis and type 2 diabetes might play a role. In a recent study hyperinsulinaemic~     euglycaemic clamps were performed and it showed that normal glucose-tolerant patients with~     moderate to severe psoriasis had lower whole-body insulin sensitivity during insulin~     stimulation compared to healthy matched controls. Thus, the increased risk of type 2~     diabetes in patients with psoriasis appears to include defects in the glucose metabolism~     linked to psoriasis itself. However, the methods applied did not allow a detailed~     characterization of the metabolism in patients with psoriasis. Tracer technique combined~     with indirect calorimetry has never been applied to study hepatic and whole body insulin~     sensitivity, and glucose and fat oxidation, during basal conditions or during insulin~     stimulation in patients with psoriasis.~      Aim of study:~      The aim of this study is to investigate hepatic and whole body insulin sensitivity and~     glucose and fat oxidation during both basal and insulin-stimulated conditions in patients~     with psoriasis.~   "
6065|NCT02977858|"~     This study is a single site prospective controlled trial assessing two educational~     interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses~     on collaboratively developed treatment guidelines for pediatric constipation. The study aims~     to assess the impact of an Spaced Education game to aid the implementation of the management~     guideline. PCP adherence to recommended treatment will be assessed in addition to PCP~     satisfaction with the educational methods, constipation knowledge and patient outcomes.~   "
6066|NCT02977845|"~     Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung~     cancer patients: A randomized control trial~   "
6067|NCT02977832|"~     Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant~     action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate~     volume, improving the patient's quality of life and eventually limiting the number of~     patients who require surgery or endoscopy after medical treatment.~   "
6055|NCT02977988|"~     Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of~     alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related~     to crime, lost work productivity and health care. While effective treatments exist, over~     half of those who enter treatment for substance use disorders drop out early in treatment~     and return to alcohol or drug abuse. Psychological stress is a causal factor in the~     pathogenesis of substance use disorder (SUD) and relapse risk. Low-income women report high~     levels of stress in SUD residential treatment stemming from significant economic and family~     stressors in addition to challenges of adjusting to residential treatment demands. Unmanaged~     stress, especially in early stages of residential treatment, is a major concern because it~     can increase dropout. Dropout from residential treatment places women at risk of substance~     use relapse. A gap in knowledge persists regarding the use of mindfulness-based~     interventions with racially/ethnically diverse low-income women with SUDs, especially~     regarding the efficacy of adapted (Mindfulness-based interventions) MBIs for preventing~     residential dropout and decreasing relapse. We have fully adapted, developed, and pilot~     tested a novel MBI, Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse~     Prevention for Women (MBRP-W), that supports the needs of women in residential treatment.~     This MBI integrates relapse prevention, addresses literacy level, and is relevant to issues~     surrounding treatment- and relapse-related stressors of disadvantaged women. The current~     project has three specific aims: (1) to test the efficacy of MBRP-W on residential treatment~     retention and substance use relapse in racially/ethnically diverse low-income women; (2) to~     determine the mechanisms of change underlying the MBRP-W program; and (3) to explore neural~     changes associated with program effects. A rationale for MBRP-W is the need for~     self-initiated stress management skills in women with SUDs during the early stressful~     periods of residential treatment that increase risk of dropout and relapse.~   "
6056|NCT02977975|"~     The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut~     in the treatment of irritable bowel syndrome.~   "
6057|NCT02977962|"~     Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young~     adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety~     disorders affect many higher-functioning adolescents and young adults with ASD, causing~     substantial distress and impairment over and above that caused by an ASD diagnosis alone.~     While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders~     among typically developing late adolescents, and work by the investigative team supports its~     utility in children with ASD and comorbid anxiety, very few evidence-based treatment~     approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the~     investigators are proposing to develop a CBT protocol for clinical anxiety that is~     personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)~     with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).~   "
6058|NCT02977949|"~     There are few reports concerning to the seasonal variation of osteoporosis treatment. In~     this study, we plan to compare clinical efficacy and safety by seasons.~   "
6059|NCT02977936|"~     The aim of the study is to evaluate at 3 months the effect of a supplementation with~     extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability~     of pain for patients suffering from gonarthritic pain.~   "
6060|NCT02977923|"~     Children with burn injuries experience severe pain intensity during medical procedures~     despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain~     management recommend the combination of non-pharmacological and pharmacological~     interventions to enhance pain management and decrease the numerous side effects of~     analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological~     method as it engages multiple senses and allows interactions with a virtual world. Oculus~     Rift ® (OR) is a new technology in VR that provides more immersiveness, at a relatively low~     cost, and could probably improve the management of pain and anxiety in burn care. It also~     has the potential, with appropriate custom software designed for burn pediatric patients, to~     reduce the cybersickness symptoms (nausea, dizziness) associated with VR. Overall~     hypothesis: Distraction by VR via the OR, in combination with the standard pharmacological~     treatment, is a feasible, acceptable and satisfactory method for the management of pain and~     anxiety during burn-related treatments in children with burn injuries.~      Note that this pilot study will precede a larger trial aimed at assessing the effect of~     virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)~   "
6061|NCT02977910|"~     Ankle fracture is very common which is often combined with deltoid ligament injury. Although~     the incidence of deltoid ligament injury is high, but there is no unified and effective~     diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs~     surgical repair is still controversial. There is no high-level, multi-center, large sample,~     long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is~     necessary or not. The main content of the project: 1 Achieve accurate classification of~     deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications~     and treatment guidelines by comparative study.~   "
6062|NCT02977897|"~     Prospective, observational pilot study of ten post-transplant patients presenting with~     diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard~     workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to~     determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once~     the diagnosis is confirmed, the patients will then be treated with a short course of~     subcutaneous Octreotide which has been shown to cure this type of diarrhea.~   "
6063|NCT02977884|"~     The project proposes to provide the Complete Health Improvement Program (CHIP) initially up~     to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members)~     with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension,~     atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve~     self-management and the consequences of biometric factors that can be modified by lifestyle~     changes. The CHIP program is an educationally based, lifestyle intervention program that~     aims to reduce healthcare cost, absenteeism, and increase employee productivity. The~     investigators expect that participants following the programs guidelines will lower their~     body mass index, cholesterol, reduce blood pressure and blood glucose levels, and therefore~     help to prevent chronic disease.~   "
6064|NCT02977871|"~     Cesarean section is the most common surgical procedure performed on women. Over the years~     minor variations of each surgical step have been introduced, and cesarean sections are not~     standardized and many different techniques are employed during surgery. Creation of a~     bladder flap has been an integral surgical step of the cesarean section for many years. The~     role of the bladder flap and its usefulness in cesarean section is not known well. Further,~     in some cases the bladder flap is omitted during cesarean section. The aim of the current~     study is to compare operating time and postoperative urinary symptoms in cesarean sections~     using either bladder flap or omission of flap.~   "
9294|NCT02935569|"~     This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression~     headband will decrease the percentage of patients with significant hair loss following~     radiation.~   "
6068|NCT02977819|"~     As the number of older people in Europe grows, increasing healthy life years is a priority.~     As people live longer, ensuring good mental as well as physical health into later years is~     becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD),~     sleep disturbances and depression, all related to psychological distress and anxiety, are~     significant drivers of reduced quality of life in older adults. This project builds on~     evidence that meditation practice have the potential to downregulate these adverse factors~     and positively impact mental and neurological conditions including AD.~   "
6069|NCT02977806|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a~     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of~     iron intervention difficult. A new method allowing accurate measurement of long-term oral~     iron absorption and allowing the estimation of iron requirements is highly needed. Such a~     novel method to quantify iron absorption and requirements using isotope dilution~     measurements in children should be validated in the present prospective observational study~     by following-up a group of 49 children given a stable iron isotope in an earlier trial. We~     will request seven blood samples within 2 years (sampling every four months) from the~     participants which will allow us to measure isotopic dilution for estimating total oral iron~     absorption over these 24 months.~   "
6070|NCT02977793|"~     The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal~     endothelium.~   "
6071|NCT02977780|"~     This research study is studying several investigational drugs as a possible treatment for~     Glioblastoma (GBM).~      The drugs involved in this study are :~        -  Abemaciclib~        -  Temozolomide (temodar)~        -  Neratinib~        -  CC115~   "
6072|NCT02977767|"~     Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction~     can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy~     surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a~     respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed~     every day from once to several times depending on the patient's secretions production and it~     is usually replaced every week. The second replacement takes place about 10 days after~     surgery. Patient education takes place at every replacement in order to empower him/her and~     in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th~     replacement, at best. Because of the risks and complications related to tracheotomy and~     because of the concerned vital function, the cannula replacement leads to anxiety especially~     during the first replacements. Usual patient's anxiety management consists in reassuring the~     patient during the replacement. In other situations, patients' anxiety management would be~     drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to~     maintain optimal breathing, they are not used in first intention. Our choice is to use~     conversational hypnosis during cannula replacement as it has already demonstrated~     interesting effects in pain and anxiety. Conversational hypnosis does not present an~     induction phase like in so-called hypnosis, it aims at leading the patient to perceive~     his/her world differently with only a slight consciousness alteration. Once the informed~     consent form is signed and when the cannula replacement has to be performed, conversational~     hypnosis session will start right from the patient's room entrance and end when the nurse~     will come out. The care will consist in aspiration, cleaning and finally replacement of the~     cannula. Adverse events are expected to be related to the cannula replacement itself:~     patients will be followed-up during a maximum of 7 days with one follow-up visit which will~     take place 2 hours after cannula replacement and a second one which can take place from the~     day after the replacement up to just before the following replacement.~   "
6073|NCT02977754|"~     The principal objective of this study is to explore the role of 18F-FDG PET in identifying~     sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease~     outcome in advanced HCC patients candidate to systemic treatment with sorafenib.~   "
6074|NCT02977741|"~     Prospective, observational study evaluating the effect of olanzapine for the treatment of~     refractory chronic nausea and vomiting.~   "
6075|NCT02977728|"~     In this project the investigators aim to evaluate olfactory and non-olfactory function in~     patients within the first 24h following a mild traumatic brain injury (acute mTBI) and~     compare their results to a group of age and sex matched control patients suffering from an~     orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year~     after the trauma~   "
6076|NCT02977715|"~     Monkeypox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in~     the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus~     infections that can prevent them from performing work duties, compromise the overall~     healthcare delivery in an already fragile system, and can result in death (case fatality~     estimates are approximately 10%).~      This is an open-label prospective cohort study in up to 1,000 eligible healthcare workers at~     risk of monkeypox infection through their daily work. The study will document monkeypox~     exposure and infection in participants while concurrently evaluating the immunogenicity and~     safety of the vaccine, IMVAMUNE, in healthcare personnel in the DRC. Participation in the~     study is voluntary and open to male and female healthcare personnel ages 18 years and older~     in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus~     infection through their daily work or laboratory personnel performing diagnostic testing for~     monkeypox virus.~   "
6077|NCT02977702|"~     The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an~     independent prognostic factor of overall survival in patients with pancreatic~     adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the~     follow-up.~   "
6078|NCT02977689|"~     The purpose of this study is to found out if the drug IDH305 is safe and effective in~     subjects with IDH1 mutant grade II or III glioma that has progressed after observation or~     radiation therapy.~   "
6079|NCT02977676|"~     The aim of this study is to determine the prevalence of ventilator-associated events (VAE).~     To analyze the patients profile, morbidity and mortality compared to patients who did not~     develope VAE. The preventability of VAE will be assessed by comparing the percentage of~     adherence to the bundle of preventive measures among patients who developed and did not~     develope VAE.~   "
6104|NCT02977299|"~     This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment~     arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing,~     stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a~     therapeutically sufficient dose for a sufficient treatment period, which would be expected~     to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ).~     Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a)~     aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR.~   "
6105|NCT02977286|"~     This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in~     critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the~     participants will receive naloxegol and a laxative protocol and half the participants will~     receive a placebo and a laxative protocol.~   "
6080|NCT02977663|"~     1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and~          molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic~          Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor~          Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and~          follow-up informations (Response to first-line treatment (Response Evaluation Criteria~          in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).~        2. To propose a simple severity scoring system based on tumor features such as size,~          doubling time (if available), location, amount of enhancement and necrosis. Such~          approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images~          (VASARI)) but is not available for the lung. The objective is to do better than the~          Tumor Node Metastasis (TNM) staging.~        3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer~          evaluation.~   "
6081|NCT02977650|"~     To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin~     bridge.~   "
6082|NCT02977637|"~     Magnetic resonance (MR) imaging is performed with contrast agents to highlight the blood~     vessels and allow interpretation and diagnosis of blood vessel abnormalities. HHT~     (Hereditary Hemorrhagic Telangiectasia) is a disease of blood vessels, and can suffer fatal~     bleeding if abnormal blood vessels are not detected and treated early. Patients with HHT~     also require many imaging studies through their lifetimes for surveillance of blood vessels.~     Many HHT patients also have co-existing iron deficiency anemia from bleeding in their nose~     and gastrointestinal tract, and receive daily iron therapy.~      Ferumoxytol is an alternative MR contrast agent, which is FDA (Food and Drug Administration)~     approved for the treatment of iron deficiency anemia. In addition, it is not associated with~     the risks to the kidneys of the other agents. The use of ferumoxytol for MR imaging may~     benefit the patients who do not currently receive imaging due to the contraindications of~     the conventional contrast agents. It avoids the use of ionizing radiation. Also, the~     conventional contrast agents are associated with risks. Iodinated contrast in CT is~     associated with significant risks of kidney damage. Another imaging technique, MR, uses~     gadolinium based contrast agents. Gadolinium, if used in patients with pre existing kidney~     dysfunction (defined as GFR < 30ml/min) is associated with the development of another~     devastating disease called nephrogenic systemic fibrosis. As HHT patients will require~     repeated scans throughout their lifetimes, this study will provide them a safer alternative.~      Ten patients from the HHT clinic in whom the use of ferumoxytol as an MR agent is clinically~     indicated will be invited to participate in this study, which will determine if MR with~     ferumoxytol is able to detect and characterize vascular malformations in HHT.~   "
6083|NCT02977624|"~     Objectives - To evaluate the effectiveness of an intervention program based on~     tele-rehabilitation in stroke survivors. The aim of the intervention is to improve the~     transition from rehabilitation units to community dwelling and facilitate involvement in~     life roles in the community.~      Working hypothesis - The tele-rehabilitation based program for stroke survivors will be~     effective in:~        1. Improving function in activities of daily living, participation in occupations and~          health related quality of life.~        2. Reducing the need for outpatient clinic and rehabilitation services.~        3. The intervention achievements will be maintained in 6 months follow-up~      Methodology - Participants: Stroke survivors will be selected from patients who are referred~     to the outpatient or home-based rehabilitation unit of Maccabi health services. The~     participants will be randomly assigned into two groups: The treatment group (N=30) will~     receive the intervention program in addition to standard care, and control group- standard~     care only.~      Outcome measures:~        1. Mayo-Portland Adaptability Inventory (MPAI-4)~        2. Stroke impact Scale (SIS)~        3. The Canadian Occupational Performance Measure (COPM)~        4. A 12-Item Short-Form Health Survey (SF-12)~        5. The Zarit Caregiver Burden Scale short version~      Procedure: The intervention program includes 20 video chat sessions over 10 weeks between an~     occupational therapist and the participant, in the presence of the primary care giver. The~     virtual meetings will be conducted using The Cognitive Orientation to daily Occupational~     Performance approach. The meetings will focus on problem solving for daily life situations~     and on the ability to implement the discussed strategies for a variety of activities.~     Participants will be evaluated at baseline, after the intervention, and after 6 months.~   "
6084|NCT02977611|"~     Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not~     enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to~     produce hemoglobin, which carries oxygen in the blood. When the body does not get enough~     iron, it cannot produce enough hemoglobin and you become anemic.~      The research study is looking at the side effects of using a higher dose and faster rate of~     iron sucrose infusion than what is used in standard of care. The purpose of this study is to~     see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely.~     If this can be done safely, it may reduce the total number of infusions required and the~     time for each infusion. This may be less costly and less burdensome to patients.~   "
6085|NCT02977598|"~     In this study, the investigators aimed to find out whether there is any association between~     the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the~     well-known diabetic risk factors, the investigators purposed to reveal new ones.~   "
6086|NCT02977585|"~     Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign~     to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients~     enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25~     patients at least.~        -  10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU~          admission (random 1)~        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and~          respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2~          occurs in the following first hour after Helmet CPAP treatment start, patients enrolled~          will receive endotracheal intubation, full face mask non invasive ventilation or higher~          peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.~      In investigator's experience, early worsening of severe bronchiolitis in PICU in the first~     hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.~   "
6087|NCT02977572|"~     The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV)~     performs better than a Continuous Positive Airway Pressure (CPAP) in the management of~     Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.~   "
6088|NCT02977559|"~     The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable~     Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.~      The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during~     mechanical ventilation despite differences in their structural design.~   "
7133|NCT02963857|"~     This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF~     block) for the anesthesia of the intercostal nerves anterior branches and assesses the~     association of the serratus block with a PIF block for the breast surgery.~   "
6089|NCT02977546|"~     Determination of hemodynamics plays an important role in the diagnosis of chronic heart~     failure. The gold standard is intermittent thermodilution via pulmonary artery catheter~     (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to~     the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.~     Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine~     hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery~     Catheterization include a lower risk and an operator-Independent easy handling. Some studies~     investigated the accuracy, precision and trending abilities of noninvasive pulse contour~     analysis during anesthesia and in the intensive care unit, but there is no data available~     for its use in patients with chronic heart failure. The investigators therefore initiated~     this Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with~     chronic heart failure.~   "
6090|NCT02977533|"~     Primary Objective:~      To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in~     men and women with progressive multiple sclerosis.~      Secondary Objectives:~      To assess in men and women with progressive multiple sclerosis:~        -  The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.~        -  The pharmacodynamic (PD) response to GZ402668 after a single SC dose.~   "
6091|NCT02977520|"~     Cerebral aneurysm is one of the main diseases that seriously affect human health. The most~     important treatment method is surgical clipping and endovascular embolization. Not complete~     occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This~     study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined~     with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction~     of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on.~     In addition, the model can also be used to the young doctor's training, and the patient and~     their families can be convenient and intuitive understanding of the disease, so as to form a~     good communication between doctors and patients.~   "
6092|NCT02977507|"~     The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0~     versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.~   "
6093|NCT02977494|"~     Myeloma patients with renal impairment need a rapid and effective reduction of tumor burden~     to enable renal recovery, which is correlated with prognosis of the patients. However,~     effective combination regimens are often hampered by necessary dose reductions or increased~     toxicity in renally impaired patients. The well known positive effects on renal impairment~     by Bortezomib combined with Daratumumab, which, as all monoclonal Antibody, is not renally~     excreted or metabolized and as so far known should not add significant toxicity but~     efficacy, makes the proposed combination of Daratumumab, Bortezomib and Dexamethasone highly~     attractive for renally impaired MM patients.~      In the current clinical trials with Daratumumab patients with renal function impairment (GFR~     ≤ 20 ml/min) were so far excluded. Consequently questions about efficacy, safety and~     pharmacokinetics of Daratumumab in combination with Bortezomib and Dexamethasone in patients~     with relapsed and refractory MM and severe renal impairment are still unanswered. This trial~     will answer these questions for a patient group, who has still an unmet need for novel and~     effective treatment options~   "
6094|NCT02977481|"~     Ear thermometers are often requested to be used rather than rectal thermometer (gold~     standard) for measuring the body temperature, as this method is faster and more user~     friendly. Former ear thermometers did not meet the required standards of accuracy for~     clinical use. However, a new generation of ear thermometers have been developed and widely~     used in the Emergency departments in Denmark. The devices have only been evaluated in two~     studies on adult populations, with conflicting results.~      This cross-sectional study will examine patients by measuring both ear and rectal~     temperature in the same patient at the same time on admission to an emergency department, to~     evaluate if temperature measured in the ear can be used as the standard temperature~     measurement.~   "
6095|NCT02977468|"~     Assess response to MK-3475 in both primary tumor, normal breast stroma, circulating~     lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC)~     patients.~      Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and~     intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses~     of MK-3475 prior to lumpectomy.~   "
6096|NCT02977455|"~     Existing researches show that brain is an organ highly dependent on continuous blood supply.~     Energy and oxygen required for normal physiological activities in the brain are stably~     maintained by a neurovascular regulatory mechanism, also known as functional congestion.~     While under pathological condition such as ischemia, this regulatory mechanism would be~     impaired and brain function loss and tissue damage occur. During anesthesia in cardiac~     surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and~     cerebral blood flow and therefore brain tissue is in ischemia. In this situation the~     neurovascular regulatory mechanism will function and the brain oxygen saturation also~     changes based on how this mechanism is influenced. the investigators were devoted to observe~     how this mechanism was influenced during surgery and how the neural function recovers after~     surgery so to explore the relationship between them.~   "
6106|NCT02977273|"~     Meal size is strongly influenced by a number of external features of the food environment~     which can promote over-consumption, such as the availability of palatable energy dense foods~     and large portion sizes. The current research aimed to investigate whether natural~     food-based differences in texture could be used to slow down eating rate and reduce intake~     from large portions.~      A four-session randomised crossover study assessed the effect of faster vs. slower eating~     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and~     calories) of a meal, alone and in combination with variations in meal portion size (regular~     vs. large)~   "
6107|NCT02977260|"~     Meal size is strongly influenced by a number of external features of the food environment~     which can promote over-consumption, such as the availability of palatable energy dense~     foods. The current research aimed to investigate whether natural food-based differences in~     texture could be used to slow down eating rate and reduce intake from large portions and~     higher energy dense foods.~      A four-session randomised crossover study assessed the effect of faster vs. slower eating~     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and~     calories) at a meal, alone and in combination with variations in meal energy-density (higher~     vs. lower)~   "
6108|NCT02977247|"~     The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear~     ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and~     K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of~     transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a~     replacement for screening mammography.~      SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the~     whole breast. While the patient lays prone on a padded table with one breast comfortably~     submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles~     the breast and pulses low‐frequency sound waves through the water and into the breast~     tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and~     receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from~     the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the~     sound waves off of tissue boundaries and structures within the breast, but because the~     transducer surrounds the whole breast, SoftVue also captures signals that are transmitted~     through the breast. This additional transmission data enhances the visualization of the~     anatomic structure of the breast tissue and is not currently available in any other~     commercially marketed breast ultrasound device.~      This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved~     and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki~     and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000~     women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly~     limited to case collection and is non-interventional; any investigational and/or statistical~     plans for future analyses will be prepared and registered separately, if they are applicable~     to the requirements of FDAAA 801.~      Arm 2 is limited to the cohort of diagnostic female patients of any breast density~     composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after~     diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic~     imaging and SV exams, from the same patient, demographic information, and clinical outcome~     data, will be collected during diagnostic workup. Ultrasound characteristics for all types~     of lesions, whether they are benign or malignant, will be collected as well as objective and~     subjective breast density composition data. Ultrasound image data may be acquired with~     modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'~     quality management system (QMS) and satisfy design change control standards, at select~     clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,~     validation, and verification testing for engineering and product development purposes.~      The exams and clinical data accumulated in this prospective case collection (PCC) protocol~     will populate a database from which future investigations may be designed for peer reviewed~     publication, development of user training curricula, building teaching case, and creating~     new marketing materials for SoftVue.~   "
6097|NCT02977442|"~     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells~     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes~     occurs when the cells of the body become resistant to the effects of insulin, and this~     causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and~     the heart. Understanding how insulin resistance occurs will pave the way for new therapies~     aimed at preventing and treating type 2 diabetes.~      Mitochondria are cellular structures that are responsible for turning nutrients from food,~     into the energy that our cells run on. As a result, mitochondria are known as the~     powerhouse of the cell. Mitochondria are dynamic organelles that can move within a cell to~     the areas where they are needed, and can fuse together to form large, string-like, tubular~     networks or divide into small spherical structures. The name of this process is~     mitochondrial dynamics and the process keeps the cells healthy. However, when more food is~     consumed compared to the amount of energy burned, mitochondria may become overloaded and~     dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with~     the ability of insulin to communicate within the cell. This may be a way for the cells to~     prevent further uptake of nutrients until the current supply has been exhausted. However,~     long term overload of the mitochondria may cause blood sugar levels to rise and lead to the~     development of type 2 diabetes.~      This study will provide information about the relationship between mitochondrial dynamics,~     insulin resistance and type 2 diabetes.~   "
6098|NCT02977429|"~     This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy~     and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal~     tumor surgery, and is expected to be a new monitoring index to improve the therapeutic~     effect of these patients.~   "
6099|NCT02977416|"~     During exercise, energy comes mainly from carbohydrates and lipids. The relative~     contribution of lipids and glucose as energy substrates to exercise depends on the~     parameters of the exercise (duration, intensity and level of training) and the physiological~     conditions of the subject.~      Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most~     severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines~     including TNFα. In adults with rheumatoid arthritis several studies have shown that~     treatment with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of~     energy substrates during exercise in children and adolescents with AJI, nor on the impact of~     anti-TNFα treatments on the oxidation of energetic substrates in children.~      Investigators hypothesize that, compared to healthy children, children with JIA should~     exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due~     to physical deconditioning and inflammation. In addition, those treated with anti-TNFα~     should have an oxidation profile of energy substrates at exercise different from that of~     patients not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα~     treatments modify the contribution of energy chains (aerobic, anaerobic and anaerobic~     alactic) during the exercise.~   "
6100|NCT02977403|"~     Background:~      People are constantly exposed to unhealthy foods. Some studies of adults show that training~     attention away from unhealthy foods might reduce overeating. Researchers want to see what~     happens in the brain when teens train their attention away from food through a program on a~     smartphone.~      Objective:~      To study the relationship between eating patterns, body weight, and how the brain reacts to~     different images.~      Eligibility:~      Right-handed females ages 12 17 who are overweight (Body Mass Index at or above the 85th~     percentile for age).~      Design:~      Participants will have 6 visits over about 8 months.~      Visit 1: participants will be screened with:~      Height, weight, blood pressure, and waist size measurements~      Medical history~      Physical exam~      Urine sample~      DXA scan. Participants will lie on a table while a very small dose of x-rays passes through~     the body.~      Questions about their general health, social and psychological functioning, and eating~     habits~      Parents or guardians of minor participants will answer questions about their child s~     functioning and demographic data.~      Before visits 2 6, participants will not eat or drink for about 12 hours. These visits will~     include some or all of these procedures:~      Blood drawn~      MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in~     a strong magnetic field. A device will be placed over the head.~      Meals provided. Participants will fill out rating forms.~      Simple thinking tasks~      A cone containing magnetic field detectors placed onto the head~      Medical history~      Physical exam~      Urine sample~      Participants will be assigned to a 2-week smartphone program that involves looking at~     pictures. Participants will complete short tasks and answer some questions about their~     eating habits and mood on the smartphone.~   "
6101|NCT02977338|"~     Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic~     upper airway evaluation during artificial sleep before surgical treatment for patients with~     obstructed sleep apnea (OSA).~      DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider~     it a fundamental clinical procedure that is essential before choosing the surgical~     treatment. The investigator's results so far suggest that a multilevel collapse is~     significantly associated with higher apnea hypopnea index values. The investigators think~     that the weight did not play a significant role in RDI reduction. Results till now show that~     tailored surgery based on DISE may leverage sleep surgeries outcome significantly,~     presenting 70% success rate based on the investigator's experience The aim of this study is~     to evaluate surgery results in patients who underwent DISE prior to their surgery in~     comparison to their condition prior to the treatment.~   "
6102|NCT02977325|"~     Questionnaires are often irreplaceable tools of collection of information in research and in~     the clinical practice. Coupled with other measures, they can be simple complementary tools,~     but questionnaires are sometimes the only way to collect data, such as self-service~     efficacy.~      The objective of this study is a validation of the French translation of the ASES. To~     guarantee the comparability between the original version and the translated version, the~     translation of a questionnaire supposes two essential stages: a literal translation and an~     adaptation to the cultural context, to the habits of life and to the idioms of the target~     population. This new version will afterward be validated with patient's troop.~   "
6103|NCT02977312|"~     This study assessed the efficacy and safety of generic imatinib in patients with chronic~     myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label,~     prospective study combined with retrospective data collection from files of patients with a~     diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s)~     additional to the daily practice were performed~   "
6109|NCT02977234|"~     The purpose of this study is to assess the effectiveness of hysteroscopic tubal application~     of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx,~     which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.~   "
10414|NCT02920931|"~     A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and~     Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir~     Disoproxil Fumarate) in Healthy Male Volunteers.~   "
6110|NCT02977221|"~     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior~     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very~     accurate incisions without any sutures following this procedure) may improve the speed of~     tooth alignment during orthodontic treatment. This study consists of two groups, patients~     will be randomly assigned to one of these two groups. The efficacy of this procedure on 18~     patients (experimental group) will be evaluated,whereas the second group (control group)~     will receive a traditional orthodontic therapy. The time required to achieve complete~     alignment of crowded mandibular anterior teeth (from canine to canine) will be compared~     between the two groups.~   "
6111|NCT02977208|"~     This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and~     other possible covariates on the kinetic disposition of GAB in patients undergoing GAB~     chronic treatment. Thus, patients treated with GAB, for at least one week, are being~     investigated.~   "
6112|NCT02977195|"~     For most advanced solid tumors, current therapy is inadequate at improving quality of life,~     slowing progression of disease, prolonging survival, and providing a cure. Hence, there is a~     continuous need for innovative, safer and more effective anti-cancer therapies. Our study is~     based on the dependence receptor paradigm and the associated therapeutic strategy. In~     preclinical models, preventing Netrin-1 interaction with its receptors is sufficient to~     trigger Netrin-1-expressing tumor cell death in vitro as well as tumor growth and metastasis~     inhibition in vivo. This indicates that a therapeutic approach based on Netrin-1/Netrin-1~     receptors interaction inhibition is both feasible and promising. NP137 is a first-in-class~     humanized monoclonal antibody targeting the Netrin-1 ligand, a secreted protein recently~     described as a driver of tumor initiation and progression. NP137 demonstrated anti-tumor~     activity as a single agent in several pre-clinical models of cancer, including breast and~     lung cancer. Taken together, several studies strongly support the rational for preclinical~     development and clinical evaluation of a highly potent and selective anti-Netrin-1 antibody~     in cancer patients. The proposed study is an open label, multicenter, Phase I dose~     escalation study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic~     (PD) and preliminary anti-tumor activity of NP137 administered every 2 weeks (Q2W) as single~     agent in patients with locally advanced or metastatic solid tumors. This trial will be the~     First in Human (FIH) study for NP137; there is no clinical experience with this antibody in~     the clinic. Dose escalation part will define the Maximum tolerated dose and the Recommended~     Phase II dose (MTD /RP2D) of NP137 and Expansion part will assess the PD and anti-tumor~     activity of NP137.~   "
6113|NCT02977182|"~     Injuries to the face caused by traumatic events such as motor vehicle collisions, assault,~     and falls can result in facial trauma, which can result in swelling and disfiguration that~     impairs the important functions of the face, sometimes to a life threatening degree. These~     injures and the resultant swelling can also precipitate psychological and social~     consequences.~      Lymphedema is an abnormal amount of fluid that causes swelling, usually in the arms or legs.~     The most common presentation of lymphedema is in the upper extremities due to breast cancer~     treatment (Maclellean RA et al). As such, standards of care for management of lymphedema are~     primarily derived from the cancer research literature and involve the extremities (Moffatt~     CJ. 2003 QJM). The current gold standard treatment for patients with extremity lymphedema is~     complete decongestive therapy (CDT) (Zuther 2013). CDT is a multimodal therapy consisting of~     four components: manual lymph drainage, compression wrapping, exercise, and skin care~     (Zuther 2013).These same therapeutic techniques of CDT have been employed at Our Lady of the~     Lake Regional Medical Center (OLOLRMC) and adapted to treat patients with facial trauma with~     anecdotally good results primarily related to cosmesis. To the best of our knowledge, no~     clinical studies examining the effect of lymphedema treatment in the management of blunt~     facial trauma currently exist.. Beyond the consideration of cosmesis, we also seek to~     determine if this intervention improves clinical outcomes such as time to swallowing and~     reduced time utilizing mechanical ventilation. This study will prospectively evaluate the~     use of complete decongestive therapy to test the hypothesis that this intervention results~     in improved clinical outcomes in patients with blunt facial trauma.~   "
6114|NCT02977169|"~     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with~     histologically confirmed N2 disease are a heterogeneous population, with 5-year survival~     rates ranging from 10% to 30%. Systemic recurrence following surgery is one of the major~     problems in stage IIIA(N2) patients, and the use of postoperative chemotherapy (POCT) in~     stage IIIA disease prolongs survival. The value of postoperative radiotherapy (PORT) for~     completely resected NSCLC remains controversial, as the effect on survival has been~     inconclusive. Recently, several large retrospective studies and reviews of the National~     Cancer Database indicated that modern PORT appears to confer an additional 5% survival~     advantage beyond that achieved with adjuvant chemotherapy alone. Actually, after complete~     resection and POCT, 20%-40% of cases have a risk of locoregional recurrence (LRR). Patients~     with completely resected stage IIIA(N2) disease might hold different postoperative~     patterns-of-failure and prognosis. It is not yet known for subsets with specific prognostic~     factors that confer lower LRR risks, whether giving PORT is more effective than no radiation~     therapy in treating patients with completely resected pathologic stage IIIA(N2) NSCLC.~      Purpose: This randomized phase II trial is studying the clinical efficacy of PORT~     administered using three-dimensional conformal radiotherapy (3D-CRT) techniques and the~     proposed standard PORT clinical target volume (CTV) delineation guideline in treating low~     risk of LRR patients with completely resected pathologic stage IIIA(N2) NSCLC.~   "
6139|NCT02976844|"~     Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The~     volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.~     The optimal balloon volume is directly dependent on surrounding pressure. In the present~     study,the investigators will observe the optimal volume of esophageal balloon during the~     different PEEP in bench and clinical study.~   "
6233|NCT02975622|"~     Ultrasound (US)-guided central venous catheterization is now considered standard of care~     according to recent clinical evidence, at least considering jugular vein approach. Recent~     trials suggested that even US-guided subclavian approach could be more effective that~     landmark technique. However, studies comparing both sites employing US are still lacking.~      We, therefore, designed a non-inferiority randomized controlled trial to compare these~     sites, both using US guidance, according to immediate complications following central venous~     catheterization.~   "
6115|NCT02977156|"~     The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs~     target the immune system rather than cancer cells in order to stimulate the anti-tumor~     immune response. In situ immunization is a strategy where immunomodulatory products such as~     pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune~     response. Of importance, pre-clinical rationale has demonstrated that combination of~     anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary~     resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of~     the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and~     innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via~     virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced~     recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg~     blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore,~     provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of~     GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor~     responses on local (injected) and distant (not injected) tumor sites. In solid injectable~     refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec~     to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard~     therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming.~     Our proposal is to conduct a 2-part Phase I clinical trial in order to define the~     feasibility, the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab~     in combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD~     and RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor~     effect of the combination.~   "
6116|NCT02977143|"~     In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac~     preload and cardiac output is important for clinical prognosis. Previous studies reported~     the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure~     (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients.~     The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well~     as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.~   "
6117|NCT02977130|"~     The American Diabetes Association indicates that diabetes self-management is a skill that~     diabetic patients must learn in the Diabetes Self-Management Education; thus, this~     contributes to shared care for diabetes, in which teams of physicians, professional nurses,~     and dietitians offer shared care to patients. However, according to the statistical analysis~     of the conditions of glycemic control in diabetic patients in 28 countries across 4~     continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c)~     of the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among~     diabetic patients in a shared-care program found that the percentage of patients with HbA1c~     lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed~     both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%~     during that period. These results suggest that despite the increase in the proportion of~     patients who successfully managed their diabetes, some patients still encountered difficulty~     in glycemic control.Therefore, numerous health education tools on diabetes continue to be~     developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial~     influence on the dietary habits of diabetic patients, and that individual health education~     had the largest effect on diabetes control. In addition, using the conversation map for~     diabetes control also had a substantial influence on improving health behaviors. Among~     existing studies that have adopted the conversation map, no large-scale research has been~     conducted, the research samples and relevant studies in Taiwan have been scant, and no~     theoretical foundation has been applied in evaluating the effects of the conversation map.~     Accordingly, the investigators aimed to enhance the mutual experience exchange and learning~     among diabetic patients through adopting the conversation map to observe its influence on~     their health behaviors by incorporating it into existing health education modalities.~     Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed~     for assessing the effectiveness of glycemic control in diabetic patients.~   "
6118|NCT02977117|"~     The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum~     calcification propensity in subjects with end-stage renal disease treated with~     haemodialysis.~   "
6119|NCT02977104|"~     The purpose of this study is to demonstrate that the Maestro hand held heart monitor can~     accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.~   "
6120|NCT02977091|"~     fitness and Physical activity will be evaluate in short stature children, using the Euro~     Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in~     healthy short children and with growth hormone deficiency at base line and after 6 month .~   "
6121|NCT02977078|"~     This study will use inhaler technology to observe and feedback overall patterns of~     medication use. We will look at whether this improves preventer inhaler use and reduces~     reliever inhaler overuse.~      We will also assess whether inhaler technology is patient-friendly and cost effective,~     whether it helps with treatment decisions in asthma and whether it can help us to predict~     and prevent asthma attacks.~   "
6122|NCT02977065|"~     A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess~     the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor~     CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.~   "
6123|NCT02977052|"~     This is an open-label three-arm phase 2 trial (including a Simon stage 2 design) consisting~     of 90 stage III melanoma patients randomized 1:1:1 to receive either 2 courses 3 mg/kg~     ipilimumab + 1 mg/kg nivolumab every 3 weeks (Arm A), 2 courses 1 mg/kg ipilimumab + 3 mg/kg~     nivolumab every 3 weeks (Arm B), or 2 courses ipilimumab 3 mg/kg, directly followed by 2~     courses nivolumab 3 mg/kg every 2 weeks (Arm C). All three treatment arms are applied prior~     to surgery at week 6, 30 patients per arm. Patients will be stratified according to~     treatment center. An interim analysis will be performed after 13 patients have been included~     in each arm, thus in total 39 patients have been included.~   "
6124|NCT02977039|"~     The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)~     diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular~     risk in individuals with type 2 diabetes and overweight/obesity.~   "
6125|NCT02977026|"~     Alcohol is one of the leading contributors to premature mortality and disability. Most~     people with alcohol problems will never seek treatment. There is a need to develop alternate~     ways to help problem drinkers outside of formal treatment settings.~      One promising strategy is Internet-based interventions for problem drinkers. Our recently~     completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help~     Centre; AHC) Internet intervention for problem drinkers found that, while there was a~     reduction in drinking across time for both interventions, there was no significant (p > .05)~     difference in reductions in drinking between the two interventions. Based on these results,~     it is not justifiable to say that either intervention 'worked' as there was no comparison~     condition of participants who received no active intervention. The current trial proposes to~     address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention~     control condition.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants~     identified as problem drinkers based on an initial survey will be invited to complete~     another survey in 6 months time. Those who are interested will be randomized to receive~     access to the Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC~     condition) or a feedback questionnaire (control condition). At six-months post-baseline, the~     MTurk portal will be used to send invitation emails that contain a link to the follow-up~     survey. The primary hypothesis to be tested is that participants receiving access to the AHC~     intervention will report a greater reduction in AUDIT-C scores and in number of drinks in a~     typical week than participants in the CYD intervention. Further, participants in the CYD~     condition will report a greater level of reduction AUDIT-C scores and in number of drinks in~     a typical week between the baseline survey and six-month follow-up as compared to~     participants in the no intervention control condition.~   "
6126|NCT02977013|"~     The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and~     correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary~     embolism.~   "
6127|NCT02977000|"~     Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in~     children in both developing and developed countries around the world. ROP is a~     multifactorial disease characterized by perturbation of normal vascular development in the~     retina. The pathogenesis of ROP is hypothesized to consist of two distinct phases of which~     the second phase is characterized by hypoxia-induced up-regulation of vascular endothelial~     growth factor (VEGF) and retinal neovascularization.~      Recent studies have shown a relationship between the β-adrenergic system and angiogenesis.~     This relationship has been observed in several diseases, like infantile hemangiomas, ROP,~     and neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF~     expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of~     β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further~     proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene~     deficient mice, when exposed to hypoxia and other stimuli, but this function is restored~     after gene therapy.~      Assuming in human preterm newborns with ROP that VEGF overexpression and retinal~     neovascularization in response to hypoxia might involve b-AR activation, we design~     prospective randomized study to assess the effect of oral propranolol on the progression of~     early stages of ROP in very low birth weight infants.~   "
6128|NCT02976987|"~     The infections of high grade induced by the human papilloma viruses cause precancerous~     lesions of the cervical epithelium. The progression of these lesions can lead to the onset~     of cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous~     intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'~     (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to~     complications such as infertility or a risk of preterm birth, hence the need to move towards~     a non-surgical alternative therapy.~      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy~     study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix~     exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).~      This clinical trial is a prolongation of the colvir trial, in order to~        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%~          (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade~          intraepithelial neoplasia after complete response, partial response or response failure~          at the end of the Colvir study.~        -  assess the long term (24 months) rate of recurrence of histological lesions of the~          Colvir patients after conisation, in both placebo and treatment groups.~   "
6129|NCT02976974|"~     The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive~     capsulitis of the shoulder will be studied. Furthermore, different biomechanic and~     psychosocial factors will be measured with a nine month follow-up~   "
6130|NCT02976961|"~     This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care~     innovation as add-on to usual care as compared to usual care alone in patients with an~     implantable cardioverter defibrillator.~   "
6131|NCT02976948|"~     Main objective: To compare the efficacy of a new strategy of Next Generation Sequencing~     (NGS) versus a classical Sanger strategy, for the diagnosis of patients referred to the~     laboratory for suspected systemic autoinflammatory diseases (SAID).~      Secondary objectives:~        -  Compare after 6 months the impact of these strategies on the establishment of an~          effective treatment SAID following genetic result.~        -  Compare the distribution of different forms of SAID found with each genetic diagnostic~          strategies (NGS vs classic method).~   "
6132|NCT02976935|"~     The aim of this study is to investigate the potential value of a novel imaging technique~     (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in~     patients with COPD and IPF.~   "
6133|NCT02976922|"~     Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting~     the oral mucosa. The aetiology remains unknown, but several local, systemic, immunologic,~     genetic, allergic, nutritional, and microbial factors have been proposed as causative~     agents. Clinically, RAS is characterised by recurrent bouts of one or several rounded,~     shallow, painful oral ulcers at intervals of a few months or days. The aim of this study is~     to characterise the salivary and faecal microbiome in 20 patients with RAS and compare the~     findings with those of 20 healthy controls. The study also includes a double-blind~     randomized placebo-controlled intervention with probiotics (Lactobacillus reuteri-containing~     lozenges 2 tablets daily for 3 months) or placebo. The salivary and faecal microbiome in RAS~     patients is compared before and after treatment. This study will improve our understanding~     of the pathogenesis in RAS and provide us with knowledge on potential future therapeutic~     approaches.~   "
6134|NCT02976909|"~     Paclitaxel In combination with DDP and 5-FU(TPF) as neoadjuvant chemotherapy in treating~     boundary resectable locally advanced esophageal squamous cell carcinoma: A phase II clinical~     trial.~   "
6135|NCT02976896|"~     We conduct the phase II clinical trial to further explore the efficacy and safety of~     Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma~     after the failure of conventional treatments. An exploratory molecular marker analysis will~     be performed in order to find out the beneficial population of Apatinib Mesylate.~   "
6136|NCT02976883|"~     The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection~     of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a~     diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up~     data will be collected from routine appointments, and analysed with the hypoxia scan results~     to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy~     treatment.~   "
6137|NCT02976870|"~     Anterior lumbar spinal surgery involves making an incision through the abdomen of the~     patient in order to access the spine. During this process, several internal structures are~     pushed aside in order to gain access. One of these structures is the ureter, whose function~     is to drain urine from the kidney to the bladder. One potential complication that can arise~     from this is dilation of the kidney - known as hydronephrosis. The aim of this study is to~     identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is~     complication, in order to bring this to the attention of health care professionals when~     considering this kind of surgery.~   "
6138|NCT02976857|"~     The trial is a single arm, single-center, non-randomized phase I clinical trial which is~     designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL~   "
6140|NCT02976831|"~     Plaque psoriasis vulgaris is a chronic inflammatory skin disorder, affecting 1-3% of the~     population in Europe and the United States of America (USA) and represents one of the most~     prevalent immune inflammatory diseases. AZD0284 is a potent selective inverse agonist of~     RORg, which is being developed for the management of psoriasis. The current Phase 1 study~     investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic~     (PD) properties of single and repeated doses of AZD0284. The study will be conducted in~     healthy subjects. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD),~     with Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The results from this~     study will form the basis for decisions on future studies. The study will help to identify~     appropriate, well-tolerated doses that can be administered in subsequent studies in patients~     with psoriasis.~   "
6141|NCT02976818|"~     Aortic valve stenosis (AVS), the most common form of valve disease in the western world,~     afflicts more than 1 million individuals in North America [1] and the burden of AVS is high~     and is expected to double within the next 50 years [2]. Medical therapy to prevent~     development or reduce progression of AVS is currently not available and the only effective~     treatment for AVS is aortic valve replacement, for which costs have been estimated up to~     120,000$ [3,4]. Recently, we and others have identified rs10455872 at the LPA locus as a~     susceptibility single nucleotide polymorphism (SNP) for aortic valve calcification (AVC) and~     AVS [5,6] and rs10455872 is associated with elevated plasma lipoprotein (Lp)(a) levels [7].~     Lp(a) is a LDL-like particle consisting of hepatically synthesized apolipoprotein B-100 that~     is noncovalently bound to the plasminogen-like glycoprotein apolipoprotein(a) [8]. Lp(a)~     promotes atherosclerotic stenosis, and possibly thrombosis, and has been hypothesized to~     contribute to wound healing, each of which could explain an association with AVS [9,10].~     Lp(a) is relatively refractory to both lifestyle and drug intervention, with only nicotinic~     acid and monoclonal antibody inhibition of the proprotein convertase subtilisin/kexin type 9~     that have showed reductions in Lp(a) levels [11,12]. However, the evidence that patients~     with AVS could be characterized by high Lp(a) levels is scarce. Glader et al. [13] showed~     that plasma levels of Lp(a) were almost 1.5-fold higher in 101 patients with AVS compared to~     matched controls, although this relationship did not reach statistical significance.~     Subsequent studies have also reported an association between elevated plasma Lp(a) levels~     and higher prevalence of AVS. More specifically, Kamstrup and colleagues [14] reported that~     elevated Lp(a) levels and corresponding genotypes were associated with increased risk of AVS~     in the general population with levels >90 mg/dL predicting a threefold increased risk. We~     have measured Lp(a) and oxidized phospholipids plasma levels in 220 patients with~     mild-to-moderate calcific AVS enrolled in the Aortic Stenosis Progression Observation:~     Measuring Effects of Rosuvastatin (ASTRONOMER) trial [15]. Results of this study suggest~     that high Lp(a) and oxidized phospholipids both predict calcific AVS progression, especially~     in younger patients with calcific AVS. We also found that statin therapy considerably~     increased both Lp(a) and oxidized phospholipids levels. Whether the fact that statins~     increase these risk factors for calcific AVS might explain at least to a certain extent why~     statins failed to promote calcific AVS regression or stabilization in at least four trials,~     including ASTRONOMER.~      Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by~     mutations in the LDL receptor gene that disrupt normal clearance of LDL. Phenotypic features~     characteristic of the disease's heterozygous form are 2- to 3-fold raise in plasma~     LDL-cholesterol concentrations, tendinous xanthomatosis and premature atherosclerotic~     coronary artery disease. High Lp(a) levels have been shown to explain residual~     cardiovascular disease risk in FH [16,17]. Recent studies have demonstrated that FH~     heterozygotes have elevated AVC compared with non-FH subjects [18] and that Lp(a) levels~     were positively correlated with AVC in asymptomatic FH heterozygotes [19]. Vongpromek et al.~     [19] demonstrated that plasma Lp(a) concentration is a independent risk factor for AVC in a~     cohort of 129 asymptomatic heterozygous FH patients aged between 40 and 69 years. In this~     study, AVC was significantly associated with plasma Lp(a) level, age, body mass index, blood~     pressure, duration of statin use, cholesterol-year score and coronary artery calcification~     (CAC) score.~   "
6142|NCT02976805|"~     This is a multi-centre randomized clinical trial comparing the efficacy of two different~     bowel preparation regimens for patients who have already failed a bowel preparation for~     colonoscopy.~   "
6143|NCT02976792|"~     Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic~     Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI)~     early enough to prevent an organic dysfunction triggering, consequently, cortical tubular~     necrosis.~      Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal~     Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI~     promptly. These markers, sonographic and biologic, have both the advantage to be~     non-invasive and easy to perform. Each marker seems to have sensitivity and specificity to~     predict AKI promptly after cardiac surgery. Therefore, the IRR and the NephroCheck™ test~     could become essential tests to guide clinicians in determining rapidly whether a patient~     will develop AKI after a TAVI procedure. However, so far, no study has tested the~     NephroCheck™ in patients undergoing TAVI.~      Therefore, the aim of this prospective observational study will be first to determine the~     effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure.~     The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an~     earlier stage than the traditional method an AKI.~   "
6144|NCT02976779|"~     This single center, prospective, double-blind, placebo-controlled, randomized two parts~     study (part I and part II) will assess the safety of topical cream (3% CBD and 3% THC),~     applied twice daily (bid), in healthy subjects, for up to 6 treatment weeks and additional 2~     follow-up weeks.~   "
6145|NCT02976766|"~     The purpose of this study is to determine whether gypenosides are neuroprotective in~     patients with acute optic neuritis.~   "
6146|NCT02976753|"~     The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional~     factor products in the prophylactic treatment of patients with haemophilia A over a 24-month~     prospective period. Data will also be collected for a 12 month retrospective period.~   "
6147|NCT02976740|"~     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)~     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF)~     and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who~     failed in second-line chemotherapy.~   "
6148|NCT02976727|"~     Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of~     protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis~     and may have significant benefit for the treatment of actinic keratosis by ablative~     fractional laser-primed photodynamic therapy (AFL-PDT).~   "
6149|NCT02976714|"~     The general aims of this project are (i) to identify predictive epigenetic biomarkers of~     lung disease severity in Cystic Fibrosis, (ii) to characterize a non-invasive cellular~     model, spontaneous sputum, for the analysis of these epigenetic biomarkers, (iii) to analyze~     the variations in DNA methylation for a same patient over time.~   "
6150|NCT02976701|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study~     over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary~     PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the~     study.~   "
6151|NCT02976688|"~     End-stage renal disease (ESRD) is associated with multiple comorbidities such as~     cardiovascular disease, anemia, mineral and bone disorders, malnutrition, body wasting,~     muscle loss (sarcopenia), neurological problems and infections resulting in a poor survival.~      In the pathogenesis of the uremic syndrome the altered intestinal function seems to be an~     important contributor. While the normal gut microbiota plays a prominent role in the~     maintenance of health and disease prevention, changes of its composition is associated with~     numerous diseases such as obesity, type 2 diabetes, cardiovascular disturbances and~     auto-immune diseases.In ESRD metabolic alterations of uremia results in quantitative and~     qualitative changes of its bacterial flora with an overgrowth of pathobionts (1). Due to~     concomitant disruption of the intestinal barrier function, noxious luminal products are~     translocated in the body's internal milieu (2).The accumulation of these compounds~     correlates with systemic inflammation, protein wasting and accelerated cardiovascular~     complications in hemodialysis patients (3).~      Short-chain fatty acids (SCFA) are produced in the colon and distal small intestine by~     anaerobic bacteria following fermentation of complex carbohydrates.They have been shown to~     exert anti-inflammatory, anti-cancer, antibacterial and antidiabetic effects (4).~     Supplementation of SCFA exerts anti-inflammatory actions both in intestinal epithelial cells~     (5) and in the cardiovascular system (6). They also positively influence auto- immune~     reactions /diseases (7,8).~      In this study we want to investigate in MHD patients whether a treatment with SCFA in form~     of sodium propionate (SP) modulates the systemic inflammation, insulin resistance and~     accumulation of intestinal uremic toxins.~   "
6152|NCT02976675|"~     To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children~     with growth hormone deficiency, as well as to study the feasibility of extending the dosing~     intervals (once per two weeks) of PEG Somatropin Injection.~   "
6153|NCT02976662|"~     Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating~     a large hole in the zona pellucida at the cellular junction of the trophectoderm cells~     located far away from the inner cell mass with a laser pulse before vitrification.~   "
6154|NCT02976649|"~     The purpose of this study is to propose a multi-dimensional score to predict those patients~     undergoing bariatric surgeries who will be in need for postoperative ICU admission.~   "
6155|NCT02976636|"~     The purpose of this application is to evaluate whether a pediatric weight control program~     that incorporates comprehensive parenting training with behavioral therapy can increase~     weight loss in children compared to traditional family-based behavioral therapy programs.~     Since certain parenting styles are associated with greater weight loss during interventions~     and appear to enhance the impact of key behavioral strategies, adding parenting training to~     these interventions may increase the overall effectiveness of these programs and increase~     our ability to help children obtain a healthy weight. This project could result in~     identifying an improved method of pediatric obesity treatment that provides additional~     benefits to the growth and development of children via improved self-regulatory behaviors.~   "
6156|NCT02976623|"~     The investigators hypothesized that feedback based on previously developed and validated~     metrics will improve novices' learning of procedural skills.~      The objective of this study was to determine the effect of a structured, objective and~     terminal feedback on novices' performance skills of ultrasonography part of~     ultrasound-guided axillary brachial plexus block.~   "
6157|NCT02976610|"~     This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of~     care test is introduced in an emergency department.~   "
6158|NCT02976597|"~     Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that~     involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides~     adequate post-operative pain relieve following the various abdominal surgeries.~     Theoretically, TAP block may replace the need for epidural analgesia after abdominal~     operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by~     (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior~     abdomen.~   "
6159|NCT02976584|"~     Primarily, the investigators want to test the hypothesis that it is possible to detect~     epileptiform EEG during cardiac surgery under general anesthesia.~      Furthermore, the investigators will examine if those epileptic potentials coincide, follow~     or are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS).~     Finally, the investigators will look for independent associations between intraoperative~     seizures (with or without ischemic events) and postoperative neurological outcome, as well~     as between intraoperative seizures (with or without ischemic events) and the total amount of~     TXA given.~   "
6160|NCT02976571|"~     A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy,~     regarding post operative pain.~   "
6161|NCT02976558|"~     The allogenic stem cell transplantation (aSCT), the only curative approach for many~     hematological diseases, often leads to severe diseases or chronic conditions, leaving~     patients with physical disabilities and severe depression and impacting their quality of~     life in many cases. These consequences are still not adequately addressed by conventional~     therapies. In this study, the investigators examine the influence of the three complementary~     medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM),~     music therapy according to the TaKeTiNa method and the psychological disease processing by~     theatrical clown performance on the quality of life and the therapy process of patients~     before and after aSCT.~   "
6162|NCT02976545|"~     Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES)~     involve emotional dysregulation.~      The hypothesis of a disorder of emotional experience is mainly based on behavioral data and~     disturbance of autonomic responses in response to images in emotional content (Mignot et al~     2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain~     structures belonging to the limbic system in particular that seem functionally impaired in~     this population. These functional connectivity abnormalities are correlated with~     dissociation scores in PNES patients (Van der Kruijs et al 2012 and 2014).~      Investigators propose to specifically study the brain activity of PNES patients during tasks~     emotional content to identify the mechanisms involved in this emotional dysregulation. This~     work is essential to understanding the mechanisms and the development of new therapeutic~     strategies~   "
6163|NCT02976532|"~     The study is designed to evaluate the use of electromagnetic tracking in femoral derotation~     osteotomies. The goal is to raise the precision of the surgical procedure in order to~     improve the outcome in short- and long term. The electromagnetic tracking system is~     evaluated against a base line CT scan serving as reference standard.~   "
6164|NCT02976519|"~     The objective of this study is to investigate the safety, tolerability, and pharmacokinetics~     of BI 443651 in male and female healthy volunteers and subjects with Chronic Obstructive~     Pulmonary Disease (COPD) or Cystic Fibrosis (CF).~   "
6165|NCT02976506|"~     To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over~     blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive~     patients.~   "
6166|NCT02976493|"~     BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of~     elotuzumab in clinical practice in Japan.~   "
6167|NCT02976480|"~     The purpose of this study is to determine whether the irrigation or non-irrigation of a~     simple laceration treated in the emergency department has an effect on the subsequent rate~     of infection.~   "
6168|NCT02976467|"~     The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor~     BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period~     in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI).~     BAY1142524 or placebo will be given on top of evidence-based standard of care for~     left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis~     of first signs of efficacy as determined by favourable changes in functional parameters of~     adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection~     fraction). Secondary objective is the analysis of safety and tolerability as evidenced by~     the incidence and severity of adverse events. 30 patients have to complete treatment with~     verum and 30 patients have to complete treatment with placebo.~   "
6234|NCT02975609|"~     This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of~     SBRT compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell~     Lung Cancer~   "
7018|NCT02965352|"~     This study has developed a peripheral to quantify the functional strength of children~     without motor change during the movement of grip and pinch. It was possible to know the~     exact values of these strengths, the range of motion that was made, and also if the grip~     strength was maintained during all the arc of motion.~   "
6169|NCT02976454|"~     One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of~     obesity treatment involves intensive family-based behavioral therapy, yet these programs~     often exist in tertiary care academic settings that have long wait lists and are too far~     away for families to access. Primary care providers (PCP) have been called on by several~     organizations to be the front line of obesity management, yet they are limited by a lack of~     time, resources, and skills. Thus, if we are to offer effective obesity management in the~     healthcare setting, other care models need to be developed and tested. The goal of this~     proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary~     care setting. This program relies on classic behavioral therapy strategies, self-regulation~     theory, and provides the support needed for patient/family self-management of weight loss.~     Implementing this program in the primary care setting will increase our ability to deliver~     nutrition and weight-related counseling in the primary care office and serve patients closer~     to home, thereby increasing access to effective treatment, improving adherence to~     recommended changes, and meeting the goals of Healthy People 2020.~   "
6170|NCT02976441|"~     The investigators hypothesize that this study will show that sufficient lymphocyte stem cell~     can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5~     of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300~     cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.~   "
6171|NCT02976428|"~     To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and~     proper implant position are very important during the surgical procedure. Soft tissues are~     structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and~     cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning~     may result in knee stiffness, pain, instability and limited range of motion (ROM). This may~     result in implant failure and the need for revision surgery. As part of standard practice~     orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to~     achieve optimal knee balance. New sensor-assisted technology can provide surgeons with~     measurable information to help achieve soft tissue balancing, providing surgeons with~     immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the~     sensor, gives surgeons electronic information on soft tissue balance and implant~     position.The purpose of this study is to determine if a sensor guided soft tissue balancing~     device (Verasense) is more effective at balancing the knee during surgery as compared to~     standard soft tissue balancing performed with a manual balancer device.~   "
6172|NCT02976415|"~     The purpose of this study is to determine if in-bed cycling is safe and feasible in~     critically-ill patients after open heart surgery. The investigators hypothesize that in-bed~     cycling can be safely used with this population and that it is feasible to use in a~     fast-paced cardiac intensive care unit.~   "
6173|NCT02976402|"~     The present phase I trial evaluates the feasibility of a postoperative stereotactic~     hypofractionated external beam radiation therapy delivered in patients who underwent radical~     prostatectomy with adverse pathological features or early biochemical failure. Modern~     computer-driven technology enables the implementation of ultra-high hypofractionated~     Image-Guided Radiotherapy (IGRT) safely.~      Eligible patients for this study are those with:~        -  Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical~          prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically~          assisted; there is no time limit for the date of radical prostatectomy)~        -  Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle~          involvement~        -  Undetectable post-radical prostatectomy PSA that becomes detectable and then increases~          on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL)~        -  Life expectancy: 10 years~        -  ECOG performance status of 0 -1~        -  No distant metastases, based on the following workup within 60 days prior to~          registration~        -  Magnetic resonance imaging (MRI) of the pelvis~        -  PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients~          with biochemical recurrence~        -  Patients can be on androgen deprivation therapy~        -  Ability to understand and willingness to sign a study-specific informed consent prior~          to study.~      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc~     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance~     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of~     devices that ensure stability and beam location reproducibility.~   "
6174|NCT02976389|"~     The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets~     across San Diego, Orange and LA counties (2 in each county), and determine which level of~     financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally~     increases the purchase and consumption of SNAP eligible fruits and vegetables.~   "
6175|NCT02976376|"~     Study to investigate whether a smart technology intervention can improve clinical and~     cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial~     infarction.~   "
6176|NCT02976363|"~     Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP)~     after exposure to breast radiation therapy in women. Methods: Prospective observational~     study performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this~     study consisted of women (N = 16) divided into two groups: women exposed to breast~     radiotherapy after underwent quadrantectomy surgery (n = 8); and women with no history of~     cancer (n = 8). We evaluated the strength of respiratory muscles through the Maximal~     Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) using the handset called~     manovacuometer. The examination was performed before the first session and after the~     twenty-fifth session related to the last day of the radiation treatment; evaluation of~     anthropometric data of weight and height to detect the body mass index (BMI); evaluation of~     clinical respiratory symptoms of dyspnea using the Medical Research Council (MRC) Dyspnea~     Scale and characterization of cough with Common Pulmonary Toxicity Criteria, in the~     classification of clinical pneumonitis.~   "
6177|NCT02976350|"~     The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies~     in Heart Failure with preserved Ejection Fraction.~   "
7064|NCT02964754|"~     To verify whether digital three-dimensional model-assisted internal fixation can obtain~     better effects in the repair of complex long bone fractures compared with conventional~     internal fixation.~   "
6178|NCT02976337|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization. In the~     present study, the investigators hypothesize that a high-dose target-controlled naloxone~     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a~     unilateral primary open groin hernia repair procedure. The investigators aim to show that~     latent sensitization is present in humans and is modulated by endogenous opioids.~   "
6179|NCT02976324|"~     This study evaluates the effect of external diaphragmatic pacemaker on the patients with~     chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,~     while the other half will receive routine therapy.~   "
6180|NCT02976311|"~     In this study, the investigators aimed to find out whether there are any differences in~     inflammatory reactions occured subsequent to two different cesarean delivery techniques;~     modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.~   "
6181|NCT02976298|"~     In human, the physiology of gait and balance is not clearly established. By using functional~     imaging and electrophysiological techniques, various brain regions from the cortex to the~     midbrain area, including the cerebellum, have been identified as involved in such control.~     The specific role of these structures in both the capacity to go forward (locomotion) and~     stand upright (balance), but also in the different phases of the gait initiation process,~     are not known, however. In this study,the investigators aimed to assess the specific role of~     both the supplementary motor area (SMA) and the cerebellum in postural control during the~     initiation of gait. For this purpose, the investigators plan to study the gait initiation in~     20 healthy subjects before and after functional inactivation (using inhibitory repetitive~     transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic~     and electromyographic parameters of the gait initiation will be recorded using a force~     platform, reflective markers with infrared cameras (VICON system) and lower limbs surface~     EMG electrodes.~   "
6182|NCT02976285|"~     The purpose of this study was to assess the impact and potential advantage of a novel~     synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical~     and radiological approaches. The investigators hypothesized that implanting this patch will~     improve individual shoulder function, while reducing re-tear rates compared to the current~     literature.~   "
6183|NCT02976272|"~     Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no~     gold standard treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce~     or stop the chemotherapy doses to limit degradation of the quality of life of patients with~     CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor~     for treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib~     subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity.~      However, a retrospective study reported that the prevalence of neuropathy induced by~     bortezomib after SC administration remains high and equivalent to IV route. No studies have~     quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies~     induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20~     questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders~     associated with CIPN has never been tested in this population. The objective of this study~     is twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal~     and vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative~     and qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related~     comorbidities in a population of neuropathic patients treated with bortezomib (n = 15),~     compared to control patients treated with bortezomib but non-neuropathic (n = 45).~   "
6184|NCT02976259|"~     Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue~     Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56~      Coordinating investigator:~      Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses~      1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail~     : caroline.lascoux-combe@aphp.fr~      Participating country : FRANCE~      Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal~     plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF~     (TDF) + emtricitabine (FTC) at the time of PHI.~      Secondary objectives :~        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal~          plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48~        -  To assess the frequency of intermittent shedding in seminal plasma once virological~          suppression has been achieved and until W48~        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48~        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma~        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal~          plasma~        -  Analysis by deep sequencing of the viral population (quasi-species) in both~          compartments (blood plasma and seminal plasma) before virological suppression has been~          achieved (i.e. at D0 and W12)~      Inclusion criteria :~        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or~          indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii)~          a western blot profile compatible with ongoing seroconversion (incomplete western blot~          with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative~          test for HIV antibodies followed within 3 months by a positive HIV serology~        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245~          mg/200 mg) initiated by the referee physician within a maximum of 15 days after~          diagnosis of PHI~        -  Genotypic sensitivity to TDF, FTC and DTG~        -  Patient with medical care insurance~      Exclusion criteria :~        -  Chronic infection~        -  Infection or co-infection with HIV-2~      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients~     (exploratory study)~   "
6207|NCT02975960|"~     Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and~     visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the~     treatment for these manifestations are often ineffective.~      Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem~     cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and~     tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.~      There are only few ways to manage SSc patients with skin lesion who already have treated~     with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor~     antagonist) but some times their skin lesions are critical physically and emotionally.~      Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc.~     Thus, the investigators study the efficacy and potential adverse event in Korean patients~     with SSc.~   "
6235|NCT02975596|"~     As part of an effort to increase MenB vaccine uptake among adolescents and young adults,~     study teams will conduct qualitative research to maximize the effectiveness of nationally~     recommended MenB educational materials. In this study, Study Teams will assess local~     barriers to MenB vaccination by conducting focus groups with parents, students, and health~     care professionals.~   "
6185|NCT02976246|"~     Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with~     chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20~     times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence~     arterial stiffness is of great importance for the high incidence of CVD.~      CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both~     vertebral and other fractures of low energy are associated with a high mortality.~      Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin~     (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on~     vitamin K.~      Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is~     reflected in very low concentrations of vitamin K in their blood samples. A correlation~     between vitamin K level, incidence of vascular calcification and bone density has been~     proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular~     calcification or bone strength.~      The investigators will conduct a randomized placebo controlled trial examining the clinical~     effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent~     and treat CVD and bone disease in CKD ptt.~      Primary study endpoints:~        1. Changes in arterial stiffness assessed by pulse wave examination~        2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans.~      Secondary study endpoints:~      Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood~     pressure, body composition, total and regional BMD, lateral column/aortic calcification~     score as well as a panel of correlating blood tests.~   "
6186|NCT02976233|"~     Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an~     effective method to avoid the need of endotracheal intubation (ETI) and improve survival in~     the acute care setting. Given the risks associated with either premature NIV discontinuation~     or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical~     challenge in patients with Acute Respiratory Failure (ARF).~      Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV~     weaning as well as decision of ETI are mainly supported by clinical and physiologic~     parameters. More sophisticated techniques used to predict weaning outcome during spontaneous~     breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness,~     the inconsistent results in demonstrating reproducible outcomes, the requirements of~     additional trainee personnel and complicated equipment, and the difficult application in~     awake and non-intubated patients.~      Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely~     ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as~     compared with other techniques are the less invasiveness, the avoidance of radiation hazards~     and the bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during~     spontaneous breathing may provide the assessment of both the muscle and the respiratory pump~     functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle~     shortening. The volume of diaphragm muscle mass remains constant while it contracts.~     Consequently, as the muscle shortens it thickens itself and measurements of changes in such~     a thickening (DT) are inversely related to changes in diaphragm length. Studies in patients~     with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is~     the major muscle of inspiration, the presence of diaphragm shortening and contraction may~     predict successful extubation in patients who are invasively ventilated.~      The aim of the present study is to assess whether DT as measured by ultrasound may predict~     NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).~   "
6187|NCT02976220|"~     This study is designed to evaluate the feasibility of using digital-enabled education in~     clinical care in order to improve patient outcomes related to end-stage renal disease~     (ESRD). If effective, educational interventions could be used to improve the long-term~     survival of patients with chronic kidney disease (CKD) and to make clinical care for these~     patients more cost effective.~   "
6188|NCT02976207|"~     Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical~     treatment~   "
6189|NCT02976194|"~     Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be~     measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of~     ranibizumab.~   "
6190|NCT02976181|"~     Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that~     lack of awareness of treatment and diagnostics pathways result in lower number of referrals~     to implanters of IPG.~   "
6191|NCT02976168|"~     The aim of the study is to understand the relationship between intracranial pressure~     regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the~     study tests the hypothesis that head down tilt will increase intracranial pressure (not~     measured in this study, but demonstrated in previous studies), will induce venous congestion~     andfacial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.~     The objectives of the study therefore are to assess young healthy people during HDT, and to~     assess cognitive brain functioning, cerebral tissue oxygenation (non-invasively), frontal~     skin thickness, cerebral perfusion and neuronal functioning via event-related potentials.~   "
6192|NCT02976155|"~     The goal of this study is to evaluate whether a standard enteral nutrition protocol can~     improve the efficiency in achieving nutritional goals and improve prognosis in critically~     ill patients.~   "
6193|NCT02976142|"~     The purpose of this study is to determine whether intraperitoneal immunotherapy (with~     interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more~     effective than systemic chemotherapy alone in patients with gastric cancer and verified free~     cancer cells in abdominal cavity in improving the long term outcomes and overall survival of~     further surgical treatment.~   "
6194|NCT02976129|"~     The purpose of this study is to evaluate the efficacy and safety of V565 in participants~     with active Crohn's Disease.~   "
6195|NCT02976116|"~     Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced~     non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm,~     multicenter, phase II study~   "
6196|NCT02976103|"~     This research study is studying a garment called the Jacki® recovery jacket that can be worn~     after surgery as a possible way to manage pain from surgical drains.~      The study intervention involved in this study is:~      -Jacki recovery jacket~   "
6232|NCT02975635|"~     Partially defective dental restorations might either be treated by complete replacement or~     by repair of the affected region. Repair restorations are a scientifically proven approach~     to manage failed restorations, but probably unknown to most patients. Results from this~     study and findings on the predictors of patients' therapy decisions might improve future~     patient information documents.~   "
6259|NCT02975284|"~     This study evaluates the longterm clinical outcomes, including safety and efficacy~     parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All~     patients included in de TASMA trial in the Netherlands will be asked to participate in the~     TASMA extension study.~   "
6260|NCT02975271|"~     Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn~     Injury~   "
6197|NCT02976090|"~     Despite the fact that small intestine makes up 75% of the length of the digestive tract and~     90% of its mucosal surface area, small bowel adenocarcinoma (SBA) is rare. SBA is not~     equally dispatched along the small bowel, a predisposing disease is frequently associated.~     All these data suggest particular carcinogenesis pathway. SBA carries poor prognosis at all~     stages and no standard treatment have proved efficacy. So far, no data are available for~     targeted therapy. From the literature and a previous study of our group some biologic data~     showed that SBA carcinogenesis is closer to colorectal than gastric carcinogenesis.~     Nevertheless, some differences arise (ie: low Adenomatous Polyposis Coli mutation rate or~     frequent DNA mismatch repair deficiency). Even if some trends are founded the prognostic~     value of molecular alteration and phenotype variation according to small bowel segment, or~     predisposing disease could not been demonstrate due to small sample size.~      BIONADEGE study is a planned biologic ancillary study of the NADEGE cohort that enrolled 366~     patients with SBA from 2009 to 2012 in France. The tumour blocks and clinical data of 187~     patients have been collected. The main objective is to assess the prognostic value for~     recurrence free survival (RFS) in non-metastatic patients and overall survival (OS) in~     metastatic patients of molecular alteration in a set of 46 genes and abnormal protein~     expression potentially implicated in carcinogenesis. The mains secondary objectives are: 1)~     to identify potential mutation targetable in small intestine tumours and protein expression,~     2) to state the frequency of molecular alteration according to the tumour location, stage or~     predisposing disease and established clinico-biologic correlation. Tissue microarrays will~     be performed and several potential prognostic markers will be assessed. Sequencing on tumour~     DNA will investigate the presence of 740 hot spot somatic mutations in 46 genes involved.The~     abnormal protein expression or the genetic alterations with an expected frequency superior~     to 10% will be assessed as potential prognostic factor to RFS and OS.~      These evaluations on a large cohort could allow comparison between pathways and will offer~     better knowledge of tumour molecular phenotype and prognosis will give rational for targeted~     therapy trials The predisposing diseases for SBA involved several different carcinogenesis~     pathways. Finally, a molecular classification of SBA will be attempt.~   "
6198|NCT02976077|"~     Background:~      Difficulties in social interactions are a central characteristic of people with~     schizophrenia, and can be partly explained by impairments of social cognitive processes.~     According to renown researchers, three to five social cognitive processes are usually~     altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3)~     attributional style; and (4 and 5) social perception and knowledge. The components of social~     cognition appear to be related to both symptomatology and functioning in everyday life.~      New strategies of cognitive remediation have been recently developed to target these~     deficits and few meta analyses have assessed the extent to which social cognitive~     remediation programs have led to multiple improvements for schizophrenia patients. Overall,~     it seems that such therapies showed encouraging results in both patient interest and~     motivation, and social cognitive processes.~      The RC2S therapy is the first individualized and partly computerized program through which~     patients practice social interactions and develop social cognitive abilities with simulation~     techniques in a realistic environment.~   "
6199|NCT02976064|"~     Background: The growing awareness on the health burden generated by insufficient levels of~     physical activity has prompted the interest for deploying community-based initiatives aiming~     at fostering active healthy living. It is of note, however, that, to our knowledge, none of~     the interventions evaluated so far have reached large scale adoption. The current protocol~     relies on the general hypothesis that properly tailored self-management programs, fully~     integrated in the patient's action plan with remote off-line professional support, may~     induce sustained behavioral changes resulting in exercise health behavior. Accordingly, the~     current manuscript addresses those unmet requirements, namely: i) Workflow design of the PA~     services engaging both patients and health professionals; ii) Enhanced information and~     communication technologies (ICT)-support; iii) Evaluation strategies including structured~     indicators; and, iv) Implementation of innovative business models. The main outcome of the~     current protocol will be a roadmap for large scale deployment and assessment of novel~     collaborative self-management PA services in the region of Catalonia (7.5 million citizens).~      Methods: The protocol has been designed as part of the regional deployment of integrated~     care services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018)~     test bed period.~      Aims: The protocol uses a population-health approach to addresses the four aims: i)~     Prehabilitation for high risk candidates to major surgery; ii) Community-based~     rehabilitation for clinical stable chronic patients with moderate to severe disease; and,~     iii) Promotion of physical activity and healthy lifestyles for citizens at risk and patients~     with mild disease.~   "
6200|NCT02976051|"~     Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET~     scanning~   "
6201|NCT02976038|"~     This is a Phase 2 Open-Label extension study to evaluate the long term safety and~     tolerability of daily elamipretide injections in patients with genetically confirmed Primary~     Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial~   "
6202|NCT02976025|"~     This study evaluates the impact of a longitudinal remote consultation (LRC) implementation~     strategy for collaborative care depression treatment among perinatal women receiving care~     from federally qualified health centers (FQHCs). All participating FQHCs will receive~     training in collaborative care. Cluster randomization will be used to assign the addition of~     LRC to select FQHCs. Differences in implementation success, clinical outcomes, and costs~     will be compared after a 12 month implementation period and 13-21 month sustainment period.~   "
6203|NCT02976012|"~     This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will~     receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior~     to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a~     1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks~     IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed~     by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).~   "
6204|NCT02975999|"~     The purpose of this study is to determine whether Vasopressin following the Fontan operation~     will decrease chest tube output and duration.~   "
6205|NCT02975986|"~     We will test the hypothesis that renal uptake of free (i.e. non-esterified) fatty acids~     (FFa) is increased in iuan. To accomplish this goal we will measure renal FFa uptake FFa~     uptake in vivo in patients with iuan and matched non-stone forming subjects via~     single-photon emission computed tomography (SPeCT)/CT imaging.~      The definitive proof of our hypothesis rests on whether increased renal FFa uptake is~     demonstrable in humans with iuan.~   "
6206|NCT02975973|"~     Cognitive impairments in schizophrenia are the most debilitating aspect of the illness and~     poorly treated by current medications. This study investigates transcranial direct current~     stimulation (tDCS) - a safe, noninvasive weak electrical current delivery to stimulate brain~     function - as a novel therapeutic for cognition in schizophrenia. Integrating~     neurostimulation, electrophysiology and neuroimaging, this project aims to study tDCS~     effects on cognition by verifying therapeutic target engagement, evaluating the tolerability~     of tDCS sessions, and optimizing treatment parameters.~   "
6208|NCT02975947|"~     The operating theatre is deliberately made to be cold and dry to prevent bacteria from~     growing. The problem with this is that during open abdominal surgery, the intestine and the~     overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum~     from drying by applying warmed saline packs periodically to the bowel. However, this is not~     always possible. Sometimes, the surgeon has to perform an important component of the~     procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries.~     When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum~     causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel~     obstruction. This vicious cycle is repeated when the patient undergoes repetitive open~     abdominal operations.~      This study aimed to be the first human study to:~        1. Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also~          to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated~          during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is~          increased for pro-inflammatory cytokines. This study also aim to show that~          proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using~          Western Blotting) are elevated during the course of the operation.~        2. Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to~          the bowel/peritoneum drying (dessication).~      This study will attempt to prove this by using humidified, warmed carbon dioxide gas which~     will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the~     peritoneal injury and the inflammation. The investigators will attain peritoneal samples~     during open colorectal operations. The investigators will obtain samples at the beginning~     and end of the operation. This study design is a randomized controlled trial, where half the~     patients will receive humidified, warmed carbon dioxide gas during surgery, and the other~     half will get standard open surgery without carbon dioxide. 40 patients will be recruited in~     this study. Half (20) will get CO2, and other half (20) will get standard open surgery.~   "
6209|NCT02975934|"~     The purpose of this study is to determine how patients with metastatic castration-resistant~     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to~     treatment with rucaparib verses treatment with physician's choice of abiraterone acetate,~     enzalutamide, or docetaxel.~   "
6210|NCT02975921|"~     The purpose of this study is to determine whether betadine (povidone-iodine) instillation~     during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in~     promoting pleurodesis and thus reducing the time to TPC removal.~   "
6211|NCT02975908|"~     ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The~     mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion~     has been put forward. Yet, its feasibility, reliability and validity need to be tested.~     Meanwhile, the correlation of different severity and prognosis remains unclear. As so far,~     the epidemiological information about ARDS in China is lacking.~      Investigators plan to conduct a multi-center observational study（real-life study） to~     investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order~     to facilitate standardization of diagnosis and management of ARDS and provide basic data and~     idea for further clinical intervention studies.~   "
6212|NCT02975895|"~     Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual~     acuity. In most cases it can be managed with surgery, removing the own lens and replacing it~     with an artificial lens, intraocular lens (IOL). These lenses are made in different~     materials with different properties.~      Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this~     disease have an increased risk of developing cataract due to the inflammation itself and~     treatment with steroids. They also have an increased risk of complications during surgery~     and postoperatively. In this group the selection of IOL might be of greater importance.~      The aim of this prospective randomized controlled study is to compare the outcome of~     hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis~   "
6213|NCT02975882|"~     This phase I trial studies the side effects and best dose of nanoparticle albumin-bound~     rapamycin when given together with temozolomide and irinotecan hydrochloride in treating~     pediatric patients with solid tumors that have come back after a period of time during which~     the tumor could not be detected or has not responded to treatment. Nanoparticle~     albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and irinotecan~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may work~     better in treating pediatric patients with solid tumors.~   "
6214|NCT02975869|"~     This research study is evaluating the impact a collaborative palliative care and oncology~     team will have on the quality of life, symptoms, mood, and end of life outcomes of patients~     with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on~     lessening (or palliating) symptoms and assisting in coping with serious illness.~   "
6215|NCT02975856|"~     The main aim of this study is to evaluate the bioavailability of table red wine and young~     Port red wine anthocyanins in healthy men.~   "
6216|NCT02975843|"~     The purpose of this study is to investigate the lung deposition and distribution pattern of~     Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a~     Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF~     5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.~   "
6217|NCT02975830|"~     Accurate understanding of tracheobronchial anatomy is important for application of various~     airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks~     state that the anatomic orientation of the right main bronchus is at less acute angle to the~     vertical tracheal axis, although these angles tend to be similar in children younger than~     three years of ageThe visualization of the air column in tracheobronchial tree in a~     three-dimensional (3D) CT-based image is clear with the air column simulating the actual~     internal shape of the airway.~      We hypothesize that RBA and LBA are unequal as children like adults are prone to right~     mainstem intubation We have measured the right and left bronchial angle using the three~     dimensional CT based images of the air column in the tracheobronchial tree.~   "
6218|NCT02975817|"~     The investigators wish to undertake a randomized controlled non-inferiority trial to~     evaluate the ability of a simple and low-cost method (Hibler´s method of wrapping the~     patient in multiple insulating layers) to prevent intraoperative heat-loss in children~     undergoing neurosurgery under anesthesia in Malawi. The control group will be heated~     actively with the use of warm-air blankets. The aim of this study is to evaluate whether~     Hibler´s method can provide a cheap and technically simple way of adequately preserving the~     patients´ core temperature in the operating theatre in a resource-poor setting.~   "
6261|NCT02975258|"~     The goals of this study are to 1) examine the relationships among inflammation, obesity, and~     asthma in people with HIV and 2) to test if special subtypes of cells or markers are present~     in the blood and lungs of people with HIV with asthma compared to those without asthma.~   "
6219|NCT02975804|"~     Objectives:~      This proposal is to investigate the effect of a 6-week training programme using an~     Interactive computer play (ICP) on the trunk control, balance and gross motor function in~     children with cerebral palsy (CP).~      Hypothesis to be tested:~      The trunk control, balance and gross motor function of children with CP will be~     significantly improved after the ICP programme.~      Design and subjects:~      20 children (6 to 12 years old) with CP will be recruited in this pilot randomised~     controlled trial. The children will be randomly allocated into a control or treatment group~     (10 children in each arm).~      Study instruments:~      Tymo is a wireless force plate used for assessment and training.~      Intervention:~      An ICP program will be set up using the Tymo. The child uses their trunk movements in the~     ICP in sitting during the intervention. The children will receive the intervention 4~     times/week, 20 minutes/session for 6 weeks. All children will be assessed at the beginning,~     3, 6 and 12 weeks post-intervention.~      Main outcome measures:~        -  Segmental Assessment on Trunk control~        -  Pediatric Reach Test~        -  Gross Motor Function Measure 88 (GMFM 88)~        -  2-minute walk test~      Data analysis:~      As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann~     Whitney U test will be used to compare the continuous and ordinal results between the~     intervention and control groups.~      Expected results:~      The trunk control, balance and gross motor function of children with CP will be~     significantly improved after the intervention.~      Clinical significance and potential of the study:~      This is clinical trial to examine the effectiveness of a new intervention, a kind of~     interactive computer play training module, on training the trunk control for children with~     cerebral palsy. If the intervention is proven effective, it may be an adjunct to the~     conventional Physiotherapy to children with movement disorders in enhancing their trunk~     control. Better trunk control will in turn improve the daily function for these children as~     their sitting and standing balance is improved. In a long run, these children will not rely~     on expensive seating equipment to maintain their balance during schooling and at home.~   "
6220|NCT02975791|"~     After a structured teaching program anaesthetists are educated in identifying the~     cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared~     with their ability to do so with palpation. In an obese volunteer~   "
6221|NCT02975778|"~     The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and~     simple of employment, for old people able to answer to a digital scale of pain intensity.~      The main objective is to develop and to validate a model of prediction of the pain in old~     subject at the time of the care, using the measure of variation of the skin conductance.~   "
6222|NCT02975765|"~     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior~     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very~     accurate incisions without any sutures following this procedure) may improve the speed of~     tooth alignment during orthodontic treatment. This study consists of two groups, patients~     will be randomly assigned to one of these two groups. The levels of pain and discomfort of~     this procedure on 18 patients (experimental group) will be evaluated,whereas the second~     group (control group) will receive a traditional orthodontic therapy.~   "
6223|NCT02975752|"~     First-line treatment with afatinib prolongs overall survival in patients with metastatic~     non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,~     somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In~     this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19~     and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).~   "
6224|NCT02975739|"~     The main objective is to establish the feasibility of 166-Holmium microspheres for~     intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.~      Participants will receive intratumoral injections with a low radioactive 166-Holmium~     microspheres followed by surgical resection~   "
6225|NCT02975726|"~     One complication of liver disease is the buildup of fluid within the belly. This is known as~     ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of~     breath. Ascites is typically treated with medications, however when that does not work,~     patients need a procedure where a needle is inserted in the belly every few weeks to drain~     the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney~     disease from their worsening liver function or from the drainage of fluid with needles. Once~     patients have both advanced liver disease and kidney disease, their chance of dying largely~     increases.~      The present study will be the first of its kind to study a new technique to treat ascites.~     Investigators are planning to place a tube in a patient's belly to drain the excessive~     amounts of fluid. This technique is similar to how one type of dialysis is done to treat~     patients with kidney failure. This study is set as a pilot investigation in order to~     determine the feasibility of doing a larger, randomized clinical trial investigating the use~     of this novel technique. Importantly, advanced liver disease patients are at high risk to~     develop kidney disease, and therefore are an important group to focus on. Investigators~     believe that this technique will prevent or slow the development of kidney disease in liver~     failure patients, and improve their quality of life, far more than the current available~     treatments.~   "
6226|NCT02975713|"~     To evaluate the influence of circadian rhythm on progesterone levels during follicular phase~     of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.~   "
6227|NCT02975700|"~     The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and~     preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or~     metastatic KIT-mutated melanoma.~   "
6228|NCT02975687|"~     In this single-center, open-label, no control, prospective clinical trial, a total of 20~     resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be~     enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a split dose~     (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on~     day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19~     CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.~   "
6229|NCT02975674|"~     The trial is designed as a consecutive enrollment prospective one-center study. A minimum of~     30 patients will be included in the study. At implant installation, the patient will be~     randomized to receive one of the two types of implants (Control: internal hexagon connection~     implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant~     crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage~     surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12~     months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks~     after the impressions are taken.~   "
6230|NCT02975661|"~     Registration of patients after gastrointestinal cancer radical surgery, including the~     information of treatments, recurrence & metastasis, adverse events,etc.~   "
6231|NCT02975648|"~     The purpose of this study is to compare the effect of an educational model, which includes~     cardiac rehabilitation with emphasis on physical activity and telephone reinforcement, with~     the usual management of individuals undergoing to intervention coronary percutaneous, in~     relation to physical activity six months after discharge.~   "
37597|NCT02564926|"~     To evaluate the effect of dapagliflozin on body composition in Korean T2DM~     subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.~   "
6236|NCT02975583|"~     There are no medical therapies indicated for reduction of limb ischemic events. Studies of~     dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin alone (CASPAR) as well~     as studies of systemic anticoagulation (WAVE) have shown no benefit for either strategy in~     the reduction in limb vascular events. Surgical bypass grafting involves harvesting of the~     vein, warm ischemia with disruption of vaso vasorum, ischemia-reperfusion, and finally~     heightened hemodynamic stress in the new arterial environment. Vein grafts rapidly remodel~     in response to the increase in blood flow and pressure in an attempt to normalize them into~     physiological range. The investigators have previously identified 3 distinct temporal phases~     of the remodeling process: During the first 30 days following implantation is a critical~     period of luminal enlargement which appears to be an endothelium-independent process. The~     second phase occurs between 1 and 3 months and represents a period of stiffening of the vein~     graft indicating synthesis of fibrous proteins. The third period is referred to as~     biochemical remodeling wherein the vein recovers clinically measureable endothelial~     function. It is likely diabetes mellitus impacts each of these phases. TRA2°P-TIMI 50~     demonstrated a reduction in acute limb ischemic (ALI) events (42% reduction) and urgent~     peripheral arterial revascularizations (35% reduction), a finding unique among medical~     therapies. While the temporal trend in reduction in ALI events occurred early and late after~     exposure suggestion an antithrombotic mechanism, the reduction in elective revascularization~     occurred later suggested beneficial effects beyond platelet inhibition. The purpose of this~     trial is to study the physiological impact of vorapaxar on lower extremity bypass graft~     maturation and function.~   "
6237|NCT02975570|"~     The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB~     with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by~     MTBDRplus and fluoroquinolone susceptible by MTBDRsl HIV seropositive (with or without~     antiretroviral therapy) or negative (but not unknown) and Karnofsky score of >60 at sites in~     Moldova, Peru, and the Philippines.~      Patients with MDR-TB will be randomized to oral regimen of delamanid (DLM), linezolid (LZD),~     levofloxacin (LFX) and pyrazinamide (PZA) for 24, 32, 40, 48 or 56 weeks or World Health~     Organization (WHO) standard of care MDR-TB regimen (9-month modified Bangladesh regimen or~     WHO standard MDR-TB regimen).~      Primary Objective~      1. Determine the shortest duration of the delamanid-containing oral regimen that is~     non-inferior to the blended WHO standard regimen.~      Secondary Objective~        1. Define the safety and tolerability of the oral delamanid, linezolid, levofloxacin and~          pyrazinamide regimen.~        2. Determine if baseline PZA susceptibility is associated with shorter time to~          non-inferior treatment duration.~        3. Identify the relationship between delamanid and linezolid serum drug levels and time to~          sputum culture conversion among patients on the delamanid-containing oral regimen.~        4. Identify the relationship between delamanid and linezolid serum drug levels and~          occurrence of adverse events among patients on the delamanid-containing oral regimen.~   "
6238|NCT02975557|"~     The objective of this study is to establish whether patients with dry eye disease (DED) are~     able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks~     (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine~     0.15% topical eye drop solution in treating MGD (primary efficacy objective).~      Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's~     syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome~     of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.~   "
6239|NCT02975544|"~     The purpose of this study was to evaluate whether an intervention based on the social and~     emotional competence development improves the healthy lifestyles adoption in young children.~   "
6240|NCT02975531|"~     Parameterize the Pompage technique with an anatomical model cervical region to simulate~     specific procedures. Quantify the times, displacements, and facilitate the training of~     students and professional of physical therapy.~   "
6241|NCT02975518|"~     We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in~     the context of vascular injury sustained during elective coronary angiography.~      We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.~   "
6242|NCT02975505|"~     The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a~     vulnerable and challenging period of time for patients and providers. Suboptimal control of~     blood pressure is known to be common in patients with the advanced stages of CKD, and may~     contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and~     mortality. This proposal is a pilot randomized controlled trial designed to test whether~     intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they~     transition to ESRD.~   "
6243|NCT02975492|"~     Recommendations for vitamin D supplementation for children between 2 and 6 years offer~     strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3~     months. Data from the literature show a further increase in the incidence of oxalo-calcium~     stones in children and adolescents associated with hypercalciuria with training Randall~     plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and~     urinary calcium excretion, these data lead to the question of increased sensitivity in some~     children with vitamin D, sensitivity could explain these situations with hypercalciuria~     increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly~     if inputs of high doses of vitamin responsible then a transient hypercalciuria with~     development of microcrystals.~   "
6244|NCT02975479|"~     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy~     in increasing doses. Patients with allergy to grass or birch will be treated with three~     intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or~     placebo.~      ***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000~     SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One~     patient had a serious adverse event with anaphylactic reaction 6 minutes after~     intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse~     events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.~   "
6262|NCT02975245|"~     This study will determine the short-term effects of chemotherapy on sperm DNA.The study~     involves the collection of semen sample through ejaculation prior to initiation of~     chemotherapy and up to three time points after initiation of chemotherapy.~   "
6245|NCT02975466|"~     A can't intubate, can't oxygenate situation is life-threatening and the physician must be~     prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is~     associated with complications. In both of these situation and as recommend by different~     societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an~     intubation conduit to ease the airway access. The objective of this randomized controlled~     trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the~     fastest intubation time in an adult population, with the objective of minimizing~     complications related to these situations. The investigators will conduct a three-arm trial~     to compare different outcomes related to the installation of the SGA and its use as an~     intubation conduit. The results of this trial will inform the anesthesiologist on which~     device to use on to have close in case of airway emergencies.~   "
6246|NCT02975453|"~     Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial~     fibrillation (NVAF) patients treated with rivaroxaban in Spain~   "
6247|NCT02975440|"~     This study will be conducted in a single center, open-label study with a single group fixed~     sequence design to evaluate the effect of repeated oral administration of 600 mg~     RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of~     VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.~   "
6248|NCT02975427|"~     Prospective, single arm, dietary intervention study.~   "
6249|NCT02975414|"~     The purpose of this study is the measurement of the evolution of the operation time during~     the start-up phase of robotic assisted surgery for the treatment of incisional hernia`s of~     40 patients treated in Maria Middelares in laparoscopic rTARUP technique.~   "
6250|NCT02975401|"~     The purpose of this study is the measurement of the evolution of the operation time during~     the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia`s of 50~     patients treated in Maria Middelares in laparoscopic rTAPP technique.~   "
6251|NCT02975388|"~     This is a multi-center, non-randomized, open-label, two-part study to investigate the effect~     of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult~     male and female participants with stable mild, moderate or severe renal impairment and a~     control group of participants with normal renal function. Part 2 will be conducted in adult~     male and female participants with stable end-stage renal disease undergoing hemodialysis.~   "
6252|NCT02975375|"~     The investigators will conduct a population-based study using health administrative data to~     evaluate the impact of preoperative geriatric consultation on postoperative outcomes in~     older patients having elective, non-cardiac surgery~   "
6253|NCT02975362|"~     The objective of this proposed study is to determine whether acupuncture combined with~     rehabilitation treatment could improve significantly motor function in ischemic stroke~     patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of~     acupuncture as additional treatment with the rehabilitation treatment, a total of 240~     patients with stroke patients will be recruited. The patients will be randomly assigned to~     acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n~     =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are~     measured using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes~     over time are measured using stroke syndrome of TCM Scale. Change in the quality of life~     over time are measured using SS-QOL scale. The study will be conducted at Shanghai~     University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan~     Hospital.~   "
6254|NCT02975349|"~     The aim of this protocol is to find out about the safety and effectiveness of M2951 in~     patients with relapsing multiple sclerosis. Patients will be placed into 1 of 3 groups to~     receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the patients on placebo~     will be given M2951.~   "
6255|NCT02975336|"~     M2951 is an investigational drug under evaluation for treatment of autoimmune and~     inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of~     M2951 in Subjects with Systemic Lupus Erythematosus (SLE)~   "
6256|NCT02975323|"~     Portal hypertension is the result of an increased hepatic vascular resistance and portal~     inflow. The best established method to assess portal pressures is the determination of~     wedged hepatic venous pressure gradient (HVPG). Ultrasound Doppler technique is non-invasive~     in the assessment of portal hypertension as compared with invasive technique of measurement~     of the hepatic venous pressure gradient (HVPG). Hemodynamic measurements (BP and pulse~     recording) will be done and then patient will be given tablet Carvedilol 12.5 mg in a single~     dose and wait till the time that 20% reduction in heart rate from the baseline occurs.~     Haemodynamic measurements will be repeated to assess the acute response to~     beta-adrenoreceptor blocker agent. The change in the HWF will be recorded post~     beta-adrenoreceptor blocker administration.~   "
6257|NCT02975310|"~     Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease~     affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and~     headache, an inability to breath through the nose and complete smell loss, regularly impair~     one's ability to work and to enjoy and participate in daily activities. The annual cost of~     chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an~     estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with~     polyps, the most common type of chronic sinusitis, is usually treated with a combination of~     medications and surgery. Until now, surgical treatment has only been performed in the~     operating room, at a cost of about $3500 per procedure. But, recent studies have shown that~     a new procedure, in-clinic polyp removal, can provide an improvement in patient symptoms~     to levels equal to those for sinus surgery performed in a hospital operating room. Moreover,~     in clinic polyp removal has additional advantages including a shorter procedure recovery~     time, a significantly lower cost to the health care system (about one-tenth the cost or~     $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the~     investigators will determine whether the in clinic polyp removal procedure is as good as~     sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis.~     The investigators will also determine the cost and health-benefits for a patient, the~     healthcare system and for society of in clinic polyp removal in comparison to sinus surgery~     done in a hospital operating room. The investigators will then know if this new treatment,~     in clinic polyp removal, can replace sinus surgery as the standard of care for these~     patients.~   "
6258|NCT02975297|"~     The purpose of this study is to identify a potential new treatment for smoking cessation.~   "
6263|NCT02975232|"~     Through research, education and extension, this project will promote fruit and vegetable~     (F&V) purchases and consumption by families in under-resourced communities, thus reducing~     health disparities, improving human nutrition, and preventing unhealthy weight gain among~     children. Specifically, this project aims to evaluate the success of promoting F&V purchases~     among low- income and Supplemental Nutrition Assistance Program (SNAP)-eligible families and~     children living in a rural Maine community through a double value coupon, supermarket- based~     incentive program combined with Cooking Matters at the Store education. Education and~     extension efforts based on the study findings will contribute to meeting USDA Childhood~     Obesity Prevention Challenge Area Goals of generating new knowledge; developing, assessing~     and expanding effective interventions; and increasing the number of skilled and informed~     professionals and consumers to address the complex problem of childhood obesity. The~     research team will partner with a large national retail grocery chain (Hannaford Brothers),~     Cooking Matters, University of Maine Cooperative Extension, eXtension Communities of~     Practice, Maine SNAP-Ed, and The Food Trust to accomplish the project objectives.~   "
6264|NCT02975219|"~     Incomplete resection of endometriosis lesions often results in recurrence of symptoms and~     the need for repeated surgery, with considerable associated morbidity. The aim of this pilot~     project is to determine the feasibility of fluorescence imaging to improve the treatment of~     endometriosis in the future.~   "
6265|NCT02975206|"~     Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic~     Dermatitis~   "
6266|NCT02975193|"~     Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor~     outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now~     an evidence-based treatment for certain cases of PD, has the risk of causing deficits in~     multiple areas of cognition.~      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic~     basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by~     measuring brain signal activity while PD patients are engaged in cognition on a computer.~   "
6267|NCT02975180|"~     Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth.~     Many of these children will have lifelong physical problems. For example, the arm muscles~     are often paralyzed. This makes every day activities, like reaching and grasping objects,~     very difficult. To date there are few effective treatments for the paralyzed arm of young~     children with stroke. The main objective of this study is to test whether a new kind of~     treatment, known as functional electrical stimulation (FES), is able to improve arm function~     in children with stroke. FES involves applying electrical currents to weak or paralyzed~     muscles. This enables movements, such as reaching and grasping, which can then be practiced.~     The investigators will compare the effectiveness of FES treatment to standard arm~     rehabilitation in children aged 3-6 years who had a stroke early in life. They will measure~     the effectiveness using a number of clinical measures of arm function. Other objectives of~     this project are to test how well children adhere to the treatment schedule, and to evaluate~     parent and child satisfaction with FES treatment.~   "
6268|NCT02975167|"~     Labor induction is one of the most common obstetric procedures performed in the U.S. In~     2012, the last year for which data is available, 23.7% of all deliveries were the result of~     inductions. Labor induction first requires cervical ripening, which can be accomplished by~     several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion,~     osmotic dilators and transcervical Foley catheters are all widely used instruments for~     pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother~     and fetus, incurs low cost, does not require extensive monitoring, and causes minimal~     maternal discomfort. The Foley catheter has been found to be both safe and effective, but~     little is known about patient satisfaction with the device in an in-patient and out-patient~     setting. The proposed study will investigate patient satisfaction in a randomized controlled~     trial of in-patient versus out-patient use of Foley catheters.~   "
6269|NCT02975154|"~     This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis~     of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive~     Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment~     with the Microcurrent treatment apparatus, but without any current. Group 4 will be a~     control group without specific interventions.~   "
6270|NCT02975141|"~     This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination~     with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal~     adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D).~   "
6271|NCT02975128|"~     This study will assess whether it is feasible to remove small breast cancers completely~     using the Breast Lesion Excision System under Ultrasound guidance.~   "
6272|NCT02975115|"~     This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a~     complete molecular response and to prove a possibility of Operational Cure in CMR~     patients.~   "
6273|NCT02975102|"~     The primary objectives of this investigation are to show that the performance of CBL-101 Eye~     Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe~     keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops~     during a 90-day period with treatment administered 3 to 6 times per day.~   "
6309|NCT02974634|"~     The purpose of this study is to test the benefits of an educational program, the Ostomy~     Self-Management Training (OSMT) program, for improving patient activation (preparedness to~     do self-care), self-efficacy (patients' ability to do self-care), knowledge of~     ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial~     burden in patients with ostomies. The study will compare patients in the intervention~     (training) group and patients in the usual care group.~      Subjects' participation in this study is expected to last about 7 months. The PI plans to~     enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School~     of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be~     coordinated by the University of Arizona in Tucson, Arizona.~   "
6310|NCT02974621|"~     This randomized phase II trial studies how well cediranib maleate and olaparib work compared~     to bevacizumab in treating patients with glioblastoma that has come back. Cediranib maleate~     and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
6274|NCT02975089|"~     The proportion of the elderly population has increased rapidly worldwide. Frailty is a~     common geriatric syndrome. Comprehensive dietary management strategy may have beneficial~     effects on frailty prevention and reversal. We compared the effects between micronutrients~     and/or protein supplement, and balanced diet on frailty status in elderly individuals who~     were at either pre-frail or frail stage. A total of 37 subjects completed a 3-month~     paralleled, single-blind, randomized control trial on (1) multiple nutrients~     supplementations, (2) multiple nutrients plus isolated soy protein supplementation, and (3)~     individualized nutrition education with designed dishware for balanced diet as well as food~     supplementations (mixed nuts and milk powder). Intervention effects on dietary intakes,~     biomarkers, frailty score and geriatric depression score (GDS) were assessed. The nutrition~     education intervention with designed dishware and milk powder/nuts supplement significantly~     increased the intake of vegetables, dairy, and nuts, along with increased concentration of~     urinary urea nitrogen of the pre-frail/frail elders. It yielded a significant reduction in~     frailty score (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated~     that the dietary approach with easy-to-comprehend dishware and food supplements to optimize~     the distribution of multiple dietary components showed its potential to improve not only~     frail status but also psychological condition in elderly.~   "
6275|NCT02975076|"~     Agents of sanchi have been widely used as a complementary medicine for stroke in China.~     Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger~     anti-platelet activity than other agents of sanchi. The investigators's aim was to~     investigate the synergistic action of aspirin combined with sanchitongshu capsule in the~     treatment of patients with minor ischemic stroke and transient ischemic attack.~   "
6276|NCT02975063|"~     Investigators will use a cluster-randomized design with three study arms to evaluate the~     impact of the Alive & Thrive infant and young child feeding communication strategies in~     Lagos and Kaduna States, Nigeria. This is a mixed methods evaluation and the quantitative~     data will be complemented by qualitative data obtained from different groups targeted by or~     involved in the program.~   "
6277|NCT02975050|"~     This study has the following objective:~      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR),~     Respiration Rate (RR), Posture and Activity in healthy human subjects.~      The μ-Cor validation will be demonstrated at two body locations:~        1. Side location (below left armpit) for study arm 1, and~        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will~          be used to support the validation of the study device.~   "
6278|NCT02975037|"~     Evaluation and validation of metabolic markers for the prediction of drug-drug interaction~     of various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in~     healthy male subjects~   "
6279|NCT02975024|"~     Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to~     enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes~     during wound healing in human subjects.~   "
6280|NCT02975011|"~     A prospective study investigating the effectiveness and safety in lumbar stenosis patients~     receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean~     Medicine through assessment of pain, functional disability, and quality of life~   "
6281|NCT02974998|"~     This two-arm cluster randomized trial will test a gender-focused comprehensive HIV testing~     and counselling (HTC) program, the Young Women's CoOperative (YWC) with a standard HTC~     program and will target female adolescents (aged 16-19) who use substances and have dropped~     out of school. To evaluate the process, the study will examine the feasibility of using peer~     role models as recruiters and co-facilitators of the intervention and monitor fidelity to~     the intervention. Efficacy of the intervention on behavioral and biological outcomes, and on~     linkages to health services, through follow-up visits conducted 6- and 12-months~     post-intervention will be also assessed.~   "
6282|NCT02974985|"~     Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity,~     viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested~     in animal models. To date, there are no studies that measure the lifting capacity of fillers~     in an in-vivo human model.~      The intention is to study the lifting capacity of fillers in a group of patients by~     comparing pre and post-procedure two and three-dimensional photographs using analytic~     software. Specifically, the PI is interested in determining the amount of tissue elevation~     created by injecting HAs Restylane-Lyft®, (Galderma Laboratories, L.P., Fort Worth, TX) to~     the midface and to the lower face, both in the anterior-posterior direction and in the~     vertical direction using analytic software.~      The research group has identified a reliable and reproducible quantitative assessment of~     midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to~     quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial~     rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from~     WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face~     deflates and descends, and, in the practice, is also a means of assessing the midface in~     youth and in aging. The PI's findings have been submitted to the Aesthetic Surgery Journal.~     The practice will attempt to utilize this metric as a measure of midface aesthetic lifting~     capacity.~      The practice will also employ 3 D photography and analytic software to determine degree of~     lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post-~     injection. (Vectra, Canfield, Fairfield, NJ)~      A secondary goal of this study is to measure duration of efficacy and patient satisfaction~     at various endpoints. A standardized rating system will be used - the Medicis Midface Volume~     Scale (MMVS) -measured by three independent physicians and the subjective Global Aesthetic~     Improvement Scale (GAIS) -measured by the subject and three independent physicians -to~     monitor outcomes at follow-up.~   "
6283|NCT02974972|"~     In this study, the investigators conducted research among HIV-infected and -uninfected~     pregnant and lactating women to understand the potential role and importance of food~     insecurity on participant physical and psychosocial health and nutrition.~   "
6284|NCT02974959|"~     The purpose of this single-center, prospective, randomized (1:1), double-blind,~     sham-controlled parallel-arm pilot study is to provide initial evidence of use of the~     noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and~     moderate traumatic brain injury to improve clinical recovery. The study compares the safety~     and effectiveness of an active gammaCore treatment against a sham treatment.~   "
6285|NCT02974946|"~     This is a prospective randomised control trial 1:1 in patients at risk of developing Acute~     Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical~     treatment. 110 patients will be recruited for each group. The aim of the study is to assess~     whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as~     compared to current practice.~   "
6286|NCT02974933|"~     The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with~     pemetrexed alone in advanced non-small cell lung cancer patients in the second or second~     line of treatment of progression-free survival~   "
6287|NCT02974920|"~     Aortic valve replacement with a biological prosthesis is the most common valve surgery~     performed with about 1000 operations performed in Denmark each year. Further, the~     introduction of percutaneous stent valves will increase these types of replacements in the~     years to come. A biological valve is a foreign body prone to cause thrombus formation at~     least until the valve is covered with recipient endothelium. There are no conclusive studies~     of anticoagulation and the investigators have shown stroke to be a common complication.~     Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and~     currently aspirin is the most common recommendation. In a register study, the investigators~     have shown that proper anticoagulation with warfarin is likely to be superior. There is a~     clear need for a large randomised study of aspirin versus anticoagulation for biological~     aortic valve replacement. This protocol describes a randomised study where 1000 patients~     will be randomised to receive either rivaroxaban or aspirin for 6 months following aortic~     valve replacement with a biological prosthesis. The primary efficacy endpoint is a combined~     event of all-cause mortality and hospitalisation for either acute myocardial infarction or~     stroke. This study has the power to settle a discussion of appropriate anticoagulation for~     this operation~   "
6288|NCT02974907|"~     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic~     Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
6289|NCT02974894|"~     In the present study the main goal has been to clarify the effect of the probiotic bacteria~     Lactobacillus plantarum 299v on the salivary cortisol level in young adults under~     examination stress. Salivary IgA from minor glands and in whole human saliva was measured as~     alternative marker of stress. The hypothesis was that the levels of cortisol would be~     reduced or stabilized in the test group in comparison to the placebo group where the~     cortisol levels were expected to increase due to the examination-induced stress. By~     contrast, the salivary IgA levels were expected to increase in the test group in comparison~     to the placebo group.~   "
6290|NCT02974881|"~     Multicenter feasibility study of the HighLife™ TMVR system.~   "
6291|NCT02974868|"~     Study B7931005 will investigate the JAK3 inhibitor PF- 06651600 and TYK2/JAK1 inhibitor~     PF-06700841 in Alopecia Areata. This Phase 2a, randomized, double blind, parallel group,~     multicenter study will enroll a total of approximately 132 subjects (expect to provide~     approximately 90 completers). The study will be conducted at approximately 30 to 40 sites.~   "
6292|NCT02974855|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of~     PF-06741086 in subjects with severe hemophilia.~   "
6293|NCT02974842|"~     This study evaluates the ability of the MAKO 7 device to collect various cells~   "
6294|NCT02974829|"~     The purpose of this study is to conduct an investigator initiated observational study to~     continue to follow up the China subset of study participants for another 5 years after they~     complete participation in the REALM Study~   "
6295|NCT02974816|"~     The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2~     diabetes managed via usual care alone and usual care augmented with remote monitoring using~     Glooko~   "
6296|NCT02974803|"~     Dabrafenib and trametinib are drugs that are usually given for the treatment of melanoma.~     Combinations of dabrafenib and trametinib have also been studied and when used together have~     shown to increase tumour shrinkage in animals compared to either drug alone. Dabrafenib and~     trametinib have also shown potential to penetrate the blood-brain-barrier when given~     together and have an effect on brain metastases. Giving these drugs at the same time and~     then giving brain stereotactic radiosurgery (SRS) may also be preferred in patients with~     brain metastases~   "
6297|NCT02974790|"~     After a basic training to echocardiography, emergency physicians will have to answer simple~     clinical questions about circulatory failure mechanisms. The objective of the study is to~     assess the agreement between these answers and those of the expert physician in patients~     admitted in the emergency department with a circulatory failure due to sepsis or not.~     Emergency physicians will volunteer to take part in a basic training on echocardiography.~     The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6~     hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the~     practice sessions will be to learn the technical grounds of transthoracic echocardiography~     (TTE), the different views and to identify the anatomical structures. The second part of the~     study will start after the training. Each eligible patient will be successively assessed by~     two investigators: one emergency physician recently trained and the expert physician. The~     echocardiography will be performed as soon as possible in the emergency department before or~     after the initiation of treatment without delaying it. The order of hemodynamic assessments~     will be random depending on the availability of the investigators; both assessments will~     however be performed within 30 minutes. Each investigator will independently read the~     echocardiography in real time at patients' bedside. They will then answer a limited list of~     standardized questions using two-choice answers or predefined choices. Finally investigators~     will choose a therapeutic proposition among a predefined list based on the answers. Only the~     results of the echocardiography performed by the expert physician will be used in patient~     management.~   "
6298|NCT02974777|"~     The purpose of this study is to determine the efficacy and safety of a routine~     individualized antiplatelet therapy after coronary stent implantation by evaluating~     on-treatment platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate®~     Analyzer).~      IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on~     bleeding events and net clinical benefit~   "
6333|NCT02974322|"~     The purpose of study is to test the effect of an experimental medication GED-0301(mongersen)~     and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The~     study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded~     which means that patients and the study doctor will not know which treatment has been~     assigned. Patients in this study will be allowed treatment with stable doses of oral~     aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment~     of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of~     exclusive enteral nutrition and growth hormone.~      All patients who complete the study will have the option to enter a long term active~     treatment study.~   "
6299|NCT02974764|"~     Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the~     United States. The high mortality for these tumors is primarily attributed to the late stage~     in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all~     stages of PDAC. Surgical resection offers the best chance for survival, but most patients~     only present with symptoms after the tumor has metastasized, and as a result are not~     operative candidates. This creates a need to both identify patients at an earlier stage~     while their cancer is still resectable, and predict the aggressiveness of the disease in~     order to better target treatment. In addition, even patients who receive curative surgery~     are at a high risk of developing recurrence of disease. Thus, there is also a need to detect~     recurrence early so appropriate treatment can be provided. As several adjuvant~     chemotherapeutic regimens are now available, it will be important to identify as soon as~     possible that the cancer has become refractory to a given therapy. This will allow one to~     progress to second or third line therapy more quickly while the tumor burden is smaller.~     This purpose of this study is to identify biomarkers in the blood of patients with PDAC and~     determine how they can change over time in relation to treatment to assess for any~     correlation with patient outcomes, response to treatment, recurrence of disease and overall~     survival. This study will be limited to patients who present to the Johns Hopkins Hospital~     between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all~     consenting patients at the time of initial diagnosis and after treatment. Patients will~     undergo treatment for their cancer based on personal preference, standard guidelines and~     discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical~     resection will also have an additional blood sample collected after resection, and patients~     who undergo chemotherapy and/or radiation will have an additional blood sample draw at the~     end of this treatment. A patient could have blood collected at multiple intervals, i.e. a~     pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery,~     and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative~     resection of PDAC blood samples will be collected till they develop clinical recurrence of~     disease. For the first 2 years following surgery samples will be collected every 3-4 months.~     Beyond that the investigators will collect samples every 6 months for the next two years.~     For all patients found to be alive and disease free beyond 4 years after surgery samples~     will be collected once every year. These patients will be followed to determine disease-free~     and overall survival. With this study, the investigators aim to assess the potential utility~     of blood biomarkers over time for pancreatic tumors which will help both with early~     detection of disease and also recurrence of disease after surgery. Biomarkers identified~     would have the potential to create a new method for early diagnosis of patients with PDAC,~     predict overall survival, response to treatment, or risk of metastatic spread, and predict~     recurrence of disease, all of which has the potential to drastically improve outcomes for~     this deadly disease.~   "
6300|NCT02974751|"~     The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the~     treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia~     (BPH).~   "
6301|NCT02974738|"~     The primary objective of this study is to identify the maximum tolerated dose (MTD) of~     PT2977 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2977 Tablets in patients with~     advanced solid tumors~   "
6302|NCT02974725|"~     To characterize safety and tolerability of LXH254 and LTT462 combination and identify a~     recommended dose and regimen.~   "
6303|NCT02974712|"~     This study aims to investigate the effects of different methods of administration on~     emergence period after laryngeal mask anesthesia in elderly patients undergoing~     transurethral endoscopic operation~   "
6304|NCT02974699|"~     There is currently a critical gap in knowledge of how intestinal bacterial communities alter~     metabolic substrates available to the host thereby influencing central and enteric nervous~     system (CNS/ENS) neurotransmitter levels involved in regulating carbohydrate consumption in~     humans. Understanding these relationships is essential for developing strategies to improve~     blood glucose control and to reduce the risk of transitioning from prediabetes to type-2~     diabetes (T2D). The investigators' long-term goal is to determine the biological~     underpinnings of behaviors that impact food intake and blood glucose control that contribute~     to the development of T2D. The objective of this proposal, which is an essential next step~     in attaining the investigators' long-term goals, is to determine how bacterial populations~     in the digestive system impact circulating tryptophan (TRP) and large neutral amino acid~     (LNAA) levels that regulate production of monoamine 5-hydroxytryptamine (5-HT, serotonin) in~     the ENS and in gastrointestinal system and the brain. The central hypothesis is that a~     reduced ratio of TRP producing (TRPp) to TRP consuming (TRPc) bacteria (decreased TRPp:TRPc~     ratio) in the gut will decrease TRP availability following a carbohydrate meal lowering the~     plasma TRP:LNAA ratio and resulting in less TRP for ENS/CNS production of 5HT. Further,~     dietary interventions that promote TRPp bacterial abundance within the gut will increase TRP~     availability to the host. The investigators will test the central hypothesis and, thereby,~     accomplish the overall objective for this project by pursuing the following specific aims:~     1) Assess impact of divergent microbiota on plasma TRP:LNAA ratio in response to acute~     carbohydrate consumption, and 2) Assess the impact of dietary supplementation with resistant~     starch (RS) on gut microbiota and circulating TRP:LNAA ratio. During Aim 1, stool samples~     will be collected from healthy participants. Participants will be stratified based on gut~     TRPp:TRPc ratio and the response to an acute meal will be assessed by determining plasma~     TRP:LNAA ratios. During Aim 2 the capacity for 4-weeks of pre-biotic RS (Potato Starch)~     supplementation to increase the TRPp:TRPc bacterial ratio in the gut will be determined from~     stool samples. Additionally, plasma TRP:LNAA ratio following acute carbohydrate consumption~     before and after supplementation will be determined. The scientific contribution will be to~     determine the impact of RS on TRPp and TRPc bacteria abundance in the gut, and how bacterial~     populations impact circulating TRP:LNAA levels, that can impact ENS and CNS 5HT production~     in humans. This contribution will be significant because it will have direct translational~     implications for human diseases with altered 5HT signaling.~   "
6305|NCT02974686|"~     Patients who receive renal transplantation at BJH are placed on triple maintenance~     immunosuppression, which means that patients take 3 types of immunosuppression drugs to~     suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone.~     However, due to the effects of MPA on the gastrointestinal tract, patients often complain of~     GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to~     an alternative agent, typically Azathioprine. Both of these strategies have limitations,~     largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar~     efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse~     effects, so the investigators will convert patients to EVR in this study. Patients who are~     within their first year post-transplant will be converted to EVR upon enrollment in the~     study, and serial measurements ,or a series of measurements looking for an increase or~     decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.~   "
6306|NCT02974673|"~     The objective of this research is to study the sphincter activity during ejaculation in~     patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this~     purpose, using a catheter the protocol plans to measure the sphincter pressures during~     ejaculation. Moreover, cardiovascular parameters will be measured continuously during the~     ejaculatory test.~   "
6307|NCT02974660|"~     Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care~     in inoperable and high-risk patients with severe, symptomatic aortic stenosis. Information~     regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate~     access site closure is scarce and based on expert consensus. Clinical practice varies~     between centers. Protamine sulphate may decrease the amount of bleeding complications~     related to the access-site. The impact on possible thromboembolic complications is unknown.~     Both bleeding and thromboembolic complications increase mortality after TAVI. A randomized~     trial is required in order to assess impact of protamine sulfate on prevalence and extent of~     bleeding and thromboembolic complications.~   "
6308|NCT02974647|"~     The purpose of this study is to test any good and bad effects of the study drug called~     ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with~     another protein called STAT and is important for survival of many T or NK-cell lymphomas. By~     blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.~   "
6334|NCT02974309|"~     A three month randomized study to examine the potential benefits of sleep extension in~     tandem with clinical trial on diabetes management in youth with type 1 diabetes.~   "
37922|NCT02560675|"~     Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment~     of risk factors and predictors of pain chronification~   "
6311|NCT02974608|"~     Background:~      Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa,~     malaria continues to be the main cause of death in young children and pregnant women.~     Researchers want to find out more about how malaria affects pregnant women and their babies.~      Objectives:~      To study the rate of miscarriage and stillbirth during the second and third trimesters among~     women in a certain district in Mali. To study rates of malaria infection over time among~     pregnant women and children in this area.~      Eligibility:~      Pregnant women of any age and pregnancy stage and their newborns. They must live in~     Ouelessebougou, Mali. Children up to 10 years old who live there.~      Design:~      Information about the study will be shared at community meetings, during visits to the~     health centers, and during census updates.~      Participants will read and sign a consent form.~      Pregnant women will be screened to see if they are eligible. They may have a urine test.~     They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take~     pictures of the body.~      Women will be enrolled in the study after they have their babies.~      Participants may have a physical exam.~      Some participants will provide a finger/heel prick blood sample.~      Participants will complete a questionnaire. They will be asked about:~      Medical history~      Antimalarial and other interventions~      Socioeconomic status~      Their pregnancy~      Previous pregnancies~      Health of their newborn...~   "
6312|NCT02974595|"~     Background:~      Some diseases cause chronic inflammation with intermittent flares in the body. These are~     called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems.~     Researchers want to learn more about the causes and effects of these diseases. They hope~     this will improve how the disease is managed in the future.~      Objectives:~      To understand the underlying immune dysregulation~      To identify the genetic cause~      To translate our findings into novel treatments that improve patients disease outcomes~      Eligibility:~      Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still's Disease, and with~     other yet undifferentiated autoinflammatory diseases.~      Unaffected relatives of participants with a known or undifferentiated autoinflammatory~     disease~      Healthy adult volunteers at least 18 years of age~      Design:~      Participants will be screened with blood sample and medical history. They may provide copies~     of their medical records.~      Enrolled participants will be evaluated at the NIH for 2-5 days. All participants will have~     a detailed medical history, physical exam, blood tests, and other evaluations depending on~     the extent of their autoinflammatory disease.~      Participants may also expect the following assessments:~        1. Clinical tests that help assess organ damage and function such as hearing, vision,~          memory, and learning tests.~        2. Imaging studies to characterize organ involvement of the inflammatory disease~          including: X-rays, CT scans, special MRIs, and bone scans.~        3. Laboratory evaluations including clinical markers of disease activity, research samples~          <TAB>for genetic studies, blood samples for cytokine/biomarker assessment, and gene~          expression profiling.<TAB>~        4. Questionnaires to assess disease activity and quality of life.~        5. If indicated, other procedures may be administered that include: a lumbar puncture if~          CNS inflammation is suspected, a skin biopsy if skin inflammation is present, and/or~          gastrointestinal and pulmonary procedures if they are clinically indicated.~      Participants may return for a single follow-up visit or for long-term follow-up visits~     depending on their disease and willingness to return. Long-term follow-up may occur for up~     to 15 years on this protocol.~   "
6313|NCT02974582|"~     Background:~      Smoking is a major public health problem in the U.S. Almost a half a million Americans die~     from it in a year. One thing that contributes to why people smoke is the marketing of~     cigarettes. Cigarette direct mail marketing usually targets young smokers of lower~     socioeconomic status. Researchers want to find out more about how this kind of marketing~     influences smoking behavior in young people from different socioeconomic levels.~      Objectives:~      To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal.~     To study how these things may differ among young adult smokers of high and low socioeconomic~     status.~      Eligibility:~      Healthy adults ages 18 to 29 who smoke.~      Design:~      Participants will have 1 visit.~      Participants will be asked questions about their health and recent smoking.~      A nurse will check their vital signs.~      Participants will have a simple eye exam.~      They will give blood and urine samples.~      Participants will be connected to equipment. This will collect data while they look at~     pictures.~      Then they will have a 10-minute break. A nurse will observe them during the break.~      Participants will have their breath analyzed.~      Participants will answer questions. The topics will include:~      Education~      Job~      Income~      Family history~      Tobacco use~      Exposure to pro-smoking and anti-smoking messages~      History of drug and alcohol use~   "
6314|NCT02974569|"~     This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which~     creates an image of the symptoms the participant is experiencing, for improving symptom~     self-management in adolescents and young adults with cancer. In this one-group trial,~     participants will complete the C-SCAT and use it during two clinic visits with their~     oncology providers.~   "
6315|NCT02974556|"~     This study aims to determine the oncological effectiveness, compared to standard surgical~     treatment, of proactive management including target organs for peritoneal spread resection~     (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and~     preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v.~     5-fluorouracil/leucovorin) following a curative resection of high-risk ( >/= 5 mm tumor~     invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development~     of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for~     patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin~     (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens.~      Hypothesis:~      The hypothesis is that compared to the standard treatment proactive management following~     curative resection of high-risk T3 and T4 colon cancer will reduce the development of~     endoperitoneal metastases~   "
6316|NCT02974543|"~     The purpose of this study is to develop and test a subject operated device to lessen~     tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.~   "
6317|NCT02974530|"~     The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing,~     Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered,~     isolated or associated manner, causing major disorders and representing a source of handicap~     for patients.~      Understanding the swallowing mechanisms is therefore a major challenge to guide the~     rehabilitation and improve the initial and long-term prognosis of patients with stroke.~      The main objective of this study is to describe and modeling, thanks to a clinical,~     physiological and radiological knowledge base, swallowing, speech and breathing, in patients~     with stroke and in healthy subjects.~   "
6335|NCT02974296|"~     The goal of this project is to guide rTMS using fMRI in individuals with depression who did~     not respond to standard TMS treatment to evaluate whether targeted TMS using individualized~     functional MRI scans produce outcome superior to that of conventional approaches. The study~     team also plans to scan MDD patients prescribed to receive standard TMS for the first time~     before and after which they will have resting-state FMRI scan in order to see if we can~     predict their responsiveness based on the functional connectivity maps.~   "
6318|NCT02974517|"~     Nowadays, the rapid development of human assisted reproductive technology (ART) has provided~     many help for couples with fertility issues. Even take baby home rate has been increased~     dramatically in the past several decades; both clinicians and embryologists are still~     struggling to improve pregnancy rates. Among all the strategies that the embryologists have~     tried, much work has been done to find better embryo culture conditions and embryo quality~     evaluation system. Currently, most centers in the world, including ours, are still using~     conventional incubators and manual embryo scoring system. This traditional method has~     several limitations, such as unstable environment during culture, and embryo scores can be~     different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed~     time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely~     daily use. In addition, its KID Score system can help embryologist select high quality~     embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles.~     The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our~     center.~   "
6319|NCT02974504|"~     A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV~     clinical trial to investigate the effect on blood glucose of evogliptin after oral~     administration in patients with type 2 diabetes~   "
6320|NCT02974491|"~     The investigators hypothesized that acute consumption of Fuji apple juice (AJ) could~     increase the antioxidant status and/or decrease the oxidative stress (OS) biomarkers,~     without increasing serum biochemical parameters in patients undergoing maintenance~     hemodialysis (MHD). In this pre-post pilot feasibility study, patients served as their own~     controls, received 300 and 150 mL AJ immediately after a dialysis section, on different~     days, with a 3 week-washout period. Blood was collected at the baseline period, after 30 and~     60 min of AJ consumption. OS biomarkers (total antioxidant status (TAS), total oxidant~     status (TOS), ascorbic acid, catalase (CAT), glutathione peroxidase (Gpx), superoxide~     dismutase (SOD) and reduced glutathione (GSH) and potassium, phosphorus, uric acid, and~     glucose concentrations were analyzed.~   "
6321|NCT02974478|"~     Aim of the study is to investigate the impact of orange juice consumption (with meals or~     between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on~     glucose homeostasis and antioxidative status.~   "
6322|NCT02974465|"~     The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper~     limb hemiparesis added to conventional physical therapy on changes in upper extremity~     functionality, motor recruitment pattern and range of motion (ROM) compared to the single~     application of conventional physical therapy. It aims to find a 22.22% difference between~     both interventions.~   "
6323|NCT02974452|"~     A cross-sectional descriptive study, in which the surface electromyographic activity of five~     shoulder muscles was compared in three populations: older adults, middle-aged adults and~     young adults. The evaluation of the electromyographic data offers a suitable foundation to~     understand aging process.~      This supports that surface electromyography provide information about the aged shoulder~     muscles. Loss of functionality is suffered by a high percentage of older adults, which~     greatly limits their physical activity. In this sense, this paper presents findings that~     might be related with possible therapeutic approaches in subsequent studies.~   "
6324|NCT02974439|"~     This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets~     5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a~     washout period of 14 days~   "
6325|NCT02974426|"~     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with~     histologically confirmed N2 disease are a heterogeneous population. After complete resection~     and postoperative chemotherapy (POCT), 20%-40% of cases have a risk of locoregional~     recurrence (LRR). Postoperative radiation therapy (PORT) should be an integral component of~     the multidisciplinary treatment for patients with stage IIIA(N2) disease. Postoperative~     Radiotherapy (PORT)-first strategy may have an advantage of the early administration of~     locoregional therapy to the mediastinum, in which the tumor burden is presumed to be higher~     than that of systematic micrometastases. It is not yet known for subsets with specific~     prognostic factors that confer higher LRR risks, what is the optimal timing of PORT and how~     to integrate with POCT (in a sequential fashion or concurrent fashion) when PORT is~     considered for patients with completely resected stage IIIA(N2) NSCLC.~      Purpose: This randomized phase III trial is studying the optimal timing of PORT to evaluate~     whether the PORT-first strategy (PORT administered first with concurrent or subsequent POCT)~     may be more effective than the PORT-last strategy (PORT administered sequentially following~     POCT) in treating high risk of LRR patients with completely resected pathologic stage~     IIIA(N2) NSCLC.~   "
6326|NCT02974413|"~     This research project has the main objective to analyze the benefits of self-care supported~     for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical~     study, randomized cluster to be developed with men aged between 40 and 70 years who have~     type 2 diabetes and are registered with the Health Strategy teams of the Municipality of~     Family Maringa. The recruited subjects will be randomly allocated into two groups:~     intervention group and control group. In the first, individuals will participate in a~     self-care intervention supported by a nurse, based on supported self-care and behavior~     change protocol; and second, individuals participate in conversation circles and will have~     the assistance normally provided by health services. The follow-up will take place for six~     months and will be collected information: socioeconomic, demographic, behavioral health,~     complications, laboratory and anthropometric. It is intended, through this study,~     demonstrate the effectiveness of this type of intervention, user-centric, on the health of~     men with DM, reinforcing this option of choice for professionals and users within the~     Primary Health Care (PHC).~   "
6336|NCT02974283|"~     The purpose of this study is to find out a serum marker for the evaluation of blood brain~     barrier damage based on animal experiments and investigate the effect of NBO（Normobaric~     hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA~     thrombolytic therapy.~   "
6337|NCT02974270|"~     Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide~     acetate~   "
6364|NCT02973919|"~     The goal of this study is to increase the efficiency of exposure in virtual reality (VR).~      Based on the EMDR research the investigators would like to show that the implementation of~     eye movements during the VR exposure results in a faster physiological relaxation response~     among probands with spider phobia, which has a positive effect on the subjective and~     behavioral efficacy of the VR exposure.~   "
6327|NCT02974400|"~     Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and~     societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis~     (CBTp), its dissemination into routine mental health care remains poor. National regulations~     such as the National Institute for Health and Care Excellence (NICE) guideline in the United~     Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but~     more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually~     not represented in the psychotherapy health service. Internet-based cognitive behavioral~     therapy (CBT) in a self-help format has been proven feasible and effective in anxiety and~     depressive disorders. Recently, Internet-based (self-help) interventions are also deployed~     via smartphone apps. The feasibility of Internet-based treatments for people with~     schizophrenia is well documented for Internet-based interventions (e.g., medication~     management) and also reported for smartphone interventions. However, there is a dearth of~     empirical studies precluding a conclusive picture. As far as the investigators know, there~     is only one study encompassing 90 participants with psychosis that investigated an~     Internet-based intervention with symptom-specific, cognitive behavioral interventions, which~     is from the investigators' research group. The unique features of the proposed project are~     1) the first-time evaluation of a symptom-oriented, CBTp-based self-help treatment for~     people with psychotic symptoms via Internet, enhanced with smartphone assistance. The study~     is set up as randomized controlled trial (RCT) with active treatment versus a wait-list~     control group. It evaluates a combined Internet-based guided self-help treatment for~     persecutory ideation and auditory verbal hallucinations. The active treatment condition~     consists of access to a self-help website including regular written electronic contact with~     a guide and access to smartphone-based interactive worksheets (apps). The trials combine the~     low-threshold advantages of an online approach (e.g., anonymity) with the virtues of a~     clinical trial (e.g., symptom assessment and diagnostic verification via Interview). The~     primary outcome measure is the Positive and Negative Syndrome Scale (PANSS). Secondary~     outcome measures include self-reported symptom measures (Paranoia Checklist; Beliefs About~     Voices Questionnaire revised), completion rates, drop-out from the intervention, general~     symptomatology, side-effects, and client satisfaction. The project will help to answer the~     empirical question whether CBTp-based interventions in a purely Internet-based self-help~     format are effective. Positive findings would pave the way for an easy-to-access treatment~     option for patients with psychotic symptoms who currently are deprived of psychotherapeutic~     treatment.~   "
6328|NCT02974387|"~     STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing~     and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy~     (PRK) surgery.~      OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral~     (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the~     eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months~     Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for~     one month, 3 x a day for one month and 2 x a day for one month Study medication will be~     administered to the randomized eye through post op days according to mention protocol. Visit~     Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal~     re-epithelialization).~   "
6329|NCT02974374|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a~     single dose of PF-06835919 in healthy adult subjects.~   "
6330|NCT02974361|"~     This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.~     Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new~     version of ibuprofen is expected to produce fewer stomach/intestine related side effects~     when compared to many existing marketed formulations of Ibuprofen.~      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6~     way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and~     allocated interventions will be confirmed after review of data from Parts A and/or B~     respectively.~      A total of 30 subjects will take part in the study; 10 per study part.~      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and~     without a selection of different excipients. The pharmacokinetic properties will include how~     quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug~     that reaches the bloodstream.~   "
6331|NCT02974348|"~     The antimalarial drugs efficacy and safety study will be conducted in the Clinics and~     hospital of the Cameroon Development Corporation (CDC) Estates, Tiko Health District,~     located in a typical forest and rainfall area in the South West Region Cameroon. In this~     study, 350 children aged 6 months to 5 years who are found to have uncomplicated symptomatic~     malaria will be enrolled between October 2012 and March 2013. Participants will be~     randomized to receive one of the following medications.~      (i) DHA+PQ : dihydroartemisinin, 2.5 mg per kg, plus piperaquine phosphate, 20mg per kg~     daily for 3 days; (ii) ART LUM : Artemether, 2mg per kg, plus lumefantrine 10mg, twice daily~     for 3 days; (iii) AS+MQ: artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a~     day for 3 days.~      All study medications will be administered orally The Primary objective of this study are to~     compare the efficacy, safety and tolerability of orally administered artemether plus~     lumefantrine (ART+LUM), artesunate plus mefloquine (AS+MQ) and dihydroartemisinin plus~     piperaquine (DHA+PQ) combinations in the treatment of uncomplicated falciparum malaria in~     Cameroon in order to provide evidence that can be used to determining the optimum~     antimalaria treatment policy in Cameroon. The secondary objectives are as follows (i) To~     valuate the efficacy and safety of artemether plus lumefantrine (ART + LUM) and artesunate~     plus mefloquine (AS + MQ) versus dihydroartemisinin plus piperaquine (DHA + PQ) combination~     (ii) To compare the clearance of asexual parasites and gametocytes in each treatment arm~     (iii) To assess the clearance of fever (iv) Assess effect of each treatment arm on anemia~     This study is a randomized, double blinded clinical trial. After enrollment, participant~     will be randomized to one of the three treatment regimen. The treatment outcome will be~     assessed through a 42-day efficacy study. Participants who will exhibit early or late~     treatment failure and those with adequate clinical response and parasitological failure on~     day 14, 28 or 42 will be treated with quinine (25mg base per kg body weight per day in three~     divided doses for five days). In addition to antimalarial drugs oral paracetamol (50mg/kg~     body weight per day in three divided doses) will be administered for fever exceeding 37.5%.~     Polymerase Chain Reaction (PCR) -corrected 28 day and 42 day efficacy will be evaluated for~     each treatment episode.~   "
6332|NCT02974335|"~     This is a 4-phase study to implement the National Institute on Drug Abuse (NIDA) Common Data~     Elements (CDEs) in primary care settings. Collecting and utilizing the CDEs in clinical~     practice requires a strategy for implementing screening to collect substance use information~     that populates the CDEs, and assisting primary care providers to offer appropriate~     interventions by providing clinical decision support (CDS) and a mechanism for making~     referrals to addiction treatment. Investigators aim to maximize the efficient adoption of~     screening, CDS, and treatment referrals by integrating all of these activities into the~     electronic health record (EHR). Incorporating the CDEs into the EHR also presents an~     opportunity to collect the NIDA/ASAM electronic clinical quality measure (eCQM), and seek to~     generate this measure following implementation of the CDEs.~      The study will be conducted at three adult primary care clinics, in two large health~     systems. Each phase will include deliverables essential to move to the next phase, and an~     independent Advisory Committee will review progress and make recommendations at each~     transition about how best to progress to each subsequent phase. Based on progress during~     earlier phases, the Advisory Committee may recommend expansion to additional clinics or~     health systems during the second part of Phase 4.~   "
6353|NCT02974062|"~     The purposes of this study were to 1) determine test-retest reliability of an iPhone~     application measurement and protocol, 2) establish minimal detectable change of an iPhone~     application measurement and protocol, and 3) determine the immediate effect of core~     stabilization exercise on trunk proprioception in healthy individuals.~   "
6413|NCT02973334|"~     This exploratory study aims at investigating the acute effects of artificially sweetened and~     sugar beverage consumption (as compared to water consumption) on acute hemodynamic and~     metabolic stress response.~   "
6338|NCT02974257|"~     This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate~     in patients who initially survive an in-hospital cardiac arrest. Patients who are~     successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical~     ventilation in the intensive care unit will be enrolled, and will get either thiamine or~     placebo. Their oxygen consumption and lactate will be measured at serial time points and~     compared between groups. The investigators' hypothesis is that thiamine will help restore~     the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an~     increase in oxygen consumption and a decrease in lactate.~   "
6339|NCT02974244|"~     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the~     treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon~     improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose~     titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other~     advantages, such as reducing insulin resistance, reducing weight, and improving blood~     pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead~     to improve outcomes in customary clinical care is unknown.~      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative~     to basal insulin initiated as first-ever injectable therapeutic regimens used in customary~     clinical care. Patients who initiated treatment with Bydureon or basal insulin between July~     2011 and March 2015 will be recruited into the study cohorts from Optum's database of~     electronic health records. The two treatment cohorts will be matched by propensity score~     method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia~     are investigated.~   "
6340|NCT02974231|"~     The objective is to report outcomes,including grade ≥2 overall late rectal and urinary~     toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80~     Gy)~   "
6341|NCT02974218|"~     The Cliniques Universitaires Saint Luc are one of the high specialized center in valvular~     heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation~     are the three valve pathology that are mainly frequent and studied.~      International guidelines in the management of valvular heart diseases are based on few~     limited old studies, mainly retrospective. And, a matter of concern is staying, about the~     timiong of surgery for asymptomatic patients.~      A prospective registry will help us to better understand the pathologies and try to better~     define guidelines criteria for surgery.~   "
6342|NCT02974205|"~     The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are~     varying. The purpose of the study is to explore if one rehabilitation option is preferable~     to one other for patients with acute PCL injury, by examining whether there will be~     differences in laxity in the knee joints and patient-reported knee function by three~     different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled~     will be followed up 3 and 12 months after injury. The groups will be compared using~     kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000)~   "
6343|NCT02974192|"~     Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of~     death and disability in industrial world. Inflammation has been reported to constitute a~     major component of ischemic stroke pathology. The brain responds to ischemic injury with an~     acute andprolonged inflammatory process. Few studies have investigated the relationship~     between acute biomarkers of inflammation and functional outcome following stroke~   "
6344|NCT02974179|"~     Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the~     AG-CLI-0206-LTFU study~   "
6345|NCT02974166|"~     The purpose of this study is to determine whether osteopathic manipulative treatment~     associated to Dentistry care and speech therapy improves pain and function in individuals~     with temporomandibular disorders.~   "
6346|NCT02974153|"~     The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention~     of migraine headache in chronic migraineurs.~   "
6347|NCT02974140|"~     The purpose of this study is to compare the refractive predictability (prediction error)~     between the Cataract Refractive Suite (CRS) and standard manual technique at one month~     post-operative~   "
6348|NCT02974127|"~     This is a prospective observational trial consisting of robotic multisession radiosurgery~     (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial~     meningiomas.~   "
6349|NCT02974114|"~     This parallel, assessor blind, placebo-controlled, stratified, randomized study will~     investigate the effects of everyday pain on cognition and mobility in otherwise healthy~     individuals.~   "
6350|NCT02974101|"~     This is a prospective, multi-center, correlation study in which the investigators aim to~     explore the relationship between subjective pain questionnaires and the AdaptiveStim~     accelerometer output.~   "
6351|NCT02974088|"~     This was a Phase IIa randomised, assessor blinded, parallel group study in which half the~     participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing~     with a head louse detection and removal comb and the remainder were treated with Nice 'n~     Clear plus combing with a normal grooming comb~   "
6352|NCT02974075|"~     Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer~     patients will develop biochemical recurrence after radical prostatectomy (RP), potentially~     because of micro metastasis at the time of the primary surgery.~      With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT,~     which allow the localization of the site of recurrence, there is increasing interest in~     metastasis directed therapies, such as salvage lymph node dissection.~      The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating~     prostate cancer patients with local recurrence after radical prostatectomy with curative~     intent. Several retrospective series has been published to determine the local value of~     sLND. Despite the first data seem to be feasible and promising, to date no prospective~     evaluation has been made. Thus sLND is still experimental according to the guidelines and is~     considered as an off label therapy.~      This prospective single center phase I/II study was conducted to investigate the safety and~     early efficacy of salvage lymph node dissection in prostate cancer patients with local~     pelvic recurrence after radical prostatectomy (RP) with curative intention.~   "
7167|NCT02963415|"~     The study will implement and test a unique Virtual Reality Cognitive Training (VRCT)~     combined with concurrent cycling on a recumbent stationary cycle, also known as exergame~     that seamlessly integrates specific cognitive tasks into a virtual environment and is~     synchronized with cycling to promote cognition.~   "
6354|NCT02974049|"~     The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug~     administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at~     least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite,~     Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM~     used in LF MDA can result in severe reactions and even death in individuals with high~     microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To~     overcome this problem, monotherapy with ALB is possible, since this drug has little or no~     effect on circulating mf and thus would not cause adverse effects in people with heavy L.~     loa infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in~     female adult worms resulting in decreased mf levels with time as natural attrition of~     circulating mf occurs. Thus this open-label, randomized clinical trial will examine~     treatment with ALB monotherapy administered twice per year over a period of 3 years with the~     primary endpoint being the proportion of individuals with total clearance of mf at 36 months~     and Alere antigen test negativity (a more sensitive circulating antigen test of filarial~     infection). Two of the treatment arms will include ALB at two different doses, 400mg or~     800mg (fixed dose twice yearly) as compared to standard treatment of ALB (400 mg) plus IVM~     (150-200 µg/kg) administered annually. Observations from an ongoing clinical trial in Papua~     New Guinea suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly~     effective in sterilizing adult female worms. Therefore to confirm and expand these important~     preliminary observations in a different population, a fourth arm will be included in the~     current clinical trial in which subjects will receive all three drugs. The clinical trial~     will be performed in a region of Cote d'Ivoire where onchocerciasis and loiasis are not~     endemic.~   "
6355|NCT02974036|"~     The overall purpose is to study quality in patient education by means of the patients'~     self-rated enablement. Specific aims are:~      To assess the validity of the patient enablement instrument in relation to self-efficacy and~     empowerment; To investigate if patient enablement can be effective in identifying which~     patients would benefit the most from patient education; To study if patient enablement has~     any relation to self-efficacy, function or self-rated health; To analyze if patient~     enablement has a causal effect on health care consumption; To evaluate whether patient~     education is a cost-effective intervention. The project is a longitudinal study, including~     patients from a patient education programme for osteoarthritis in primary health care. Data~     consist of patient reported outcome measures and health care consumption. Cost-effectiveness~     and cost-utility analysis will be used. Inclusion of patients will start August 2016.~     Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included~     are from primary health care settings and researchers in the field of OA, patient education~     and health economy. Our increasingly older and more inactive population will raise huge~     demands on the health care. The importance of optimizing treatments that are available in~     primary health care cannot be underestimated. The project will contribute with important~     knowledge about the patient's own process of getting well.~   "
6356|NCT02974023|"~     The current study was designed to evaluate the effectiveness and safety of the device in the~     common areas of the body affected by different causes of musculoskeletal pain in Vietnamese~     population in real life situation.~   "
6357|NCT02974010|"~     NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of~     d-cycloserine (DCS) and lurasidone for the maintenance of remission from Acute Suicidal~     Ideation (C-SSRS level 4 or 5) and Behavior (ASIB) in adults with Bipolar Depression~     following initial stabilization. Patients with Bipolar Depression and ASIB will be recruited~     in both inpatient and outpatient settings and, following informed consent, will be given an~     intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory~     clinical response to ketamine will be randomly allocated to NRX-101 or to a comparator~     group. The primary outcome variable is time to relapse as defined by a return to baseline in~     either depression or suicidality as determined by the treating physician or the need to~     institute a new treatment plan.~   "
6358|NCT02973997|"~     This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients~     with differentiated thyroid cancer that has spread to other places in the body or has come~     back and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and~     kinase inhibitors, such as lenvatinib, may interfere with the ability of tumor cells to grow~     and spread.~   "
6359|NCT02973984|"~     Preliminary data suggest that:~        1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices~          (MPI), may influence the anticoagulant prescription in older subjects with Atrial~          Fibrillation (AF);~        2. the presence of multidimensional impairment, disability and multi-morbidities are~          usually not included in the decision algorithm of the more appropriate treatments in~          older patients with AF;~        3. considering the prognostic information, as calculated by the MPI, can be useful to~          physicians in identifying older patients with AF that can benefit from anticoagulant~          treatment in term of increased survival.~   "
6360|NCT02973971|"~     The present single center clinical chronobiological study on 24 subjects (12 patients with~     mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing~     the ADDIA biomarkers: a) blood cell‐based biomarkers measured by flow cytometry using~     proprietary probes specific of two targeted biomarkers, beta‐Amyloid (Aβ) peptide and a~     kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be~     analyzed on samples taken at different time points of the day, including under fasting and~     non-fasting conditions and at two periods: day 1 and day 14.~   "
6361|NCT02973958|"~     Circumcision is the most common surgical procedure performed by Pediatric Urologists.~     Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic~     regimens without the commonly associated adverse effects. This study aims to see if giving~     ketorolac during the operation will result in better pain control. We hypothesize that~     ketorolac will result in pain control similar to morphine with a lower incidence of side~     effects such as nausea and vomiting.~   "
6362|NCT02973945|"~     The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary~     Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.~      Patients will be randomised in two groups, one arm will received oxygen through High Flow~     Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)~   "
6363|NCT02973932|"~     Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms~     and an age of 7 to 17 years. Sessions are verified with teleconferencing with an~     psychotherapist, children and their parents. The psychotherapy is supported by an App and a~     wristband to obtain psychophysiological data.~   "
7168|NCT02963402|"~     We can speculate that the best responders to tocilizumab should have multiple related~     elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play~     its beneficial role. The study of these elements and its pathways could help identify the~     best responders to tocilizumab treatment.~   "
6365|NCT02973906|"~     The overarching goal of this study is to advance research on family-based prevention of~     negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom~     personnel by evaluating different formats of a parenting program, After Deployment, Adaptive~     Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management~     Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine~     which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors~     associated with negative childhood outcomes by improving parenting, child, and parent~     adjustment. There is a clear intent to benefit all subjects in this study (except surveyed~     teachers), including children.~   "
6366|NCT02973893|"~     The purpose of this study is to determine if VF001-DP improves wound healing in chronic~     venous leg ulcers compared to standard care only.~   "
6367|NCT02973880|"~     Cataract is an ophthalmic disease that usually affects the elderly population. Cataract~     surgery with phaco-emulsification is now the most frequently performed intraocular surgical~     procedure in the developed world. However, differences in surgical technique impact the~     severity of surgical trauma and post-operative recovery. The amount of post-operative ocular~     pain and inflammation plays a significant role in the Patient's perception of the surgical~     success.~      Several ophthalmic products have been studied in the management of post-surgery ocular~     inflammation and pain following cataract surgery. Corticosteroids are considered the gold~     standard for the treatment of ocular inflammation, and their most commonly used route of~     administration is the topical instillation as eye drops formulation.~      After topical administration of Dexamethasone, the concentration in the anterior chamber~     increases and declines within hours, necessitating frequent daily instillations of eye drops~     for several weeks. This might be associated with compliance issues, particularly in elderly~     Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a~     less frequent administration could therefore be an attractive alternative.~      NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and~     Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new~     ophthalmic gel, preservative-free formulation has been developed. This new formulation has~     been tested in pre-clinical animal studies and in a clinical trial. The new formulation~     contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for~     food products. It is used in the product as viscosity enhancer and to give to the product~     pseudo-plastic characteristics and prolonged ocular retention time.~      The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™~     gel 2 times a day starting on the day of cataract extraction by means of~     phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a~     non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for~     the same period.~   "
6368|NCT02973867|"~     We showed, for the first time, that Z-score increase during obesity was dependent on sex,~     severity of obesity and age but also on the bone site. Although the increase in BMD at~     bearing areas seems to be logically explained by the assumption that mechanical stresses~     have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant~     increase in BMD at non-load bearing areas such as the radius. These results suggest that~     changes in certain systemic compounds, induced by obesity, may interfere with bone~     metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated~     with muscle mass and not with fat mass confirm that mechanical stresses are not the only~     factors acting on bone tissue.~      Our objectives are to determine the relationship between plasma concentration of myokines,~     adipokines, bone markers and BMD in obese subjects.~   "
6369|NCT02973854|"~     Patients seen at the Center for Endometriosis (including those with or without pain)~     undergoing laser excision surgery for known or suspected endometriosis will be recruited for~     the study.~      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum~     will be excised (removed).~      After surgical excision has been performed, in order to provide standardized specimens for~     our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3~     mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue~     will be sent to histology (SSM) for evaluation and classification as having endometriosis or~     not. For each patient in the study, blood will also be collected to look for markers for~     endometriosis.~   "
6370|NCT02972879|"~     The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin,~     ultrasound and orthotics) versus corticosteroid injection for trigger finger.~   "
6371|NCT02972866|"~     This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral~     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients~     will receive Astrazeneca medication. There is no placebo group.~   "
6372|NCT02972853|"~     The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care~     (see study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A~     Pilot Study) improves chronic disease management and 2) changes brain activation in~     neuroimaging tasks before compared to after the training. Neuroimaging fMRI tasks probe~     mechanisms related to self-regulation, such as attention/inhibition, emotion regulation,~     self-compassion, interoception and pain regulation.~      The study will also look at whether successful chronic disease management relates to the~     observed brain activation changes after compared to before the mindfulness intervention.~   "
6373|NCT02972840|"~     This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and~     rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle~     cell lymphoma.~   "
6374|NCT02973841|"~     A novel device attached to ultrasound probe designed to increase success rate and safety of~     internal jugular vein cannulation.~   "
6375|NCT02973828|"~     In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment~     to locate the tumour and ensure the radiation is hitting the target.~      These x-rays expose patients to additional radiation and the quality of these scans is often~     poor which makes it difficult to distinguish tumour from normal tissue and there may be~     uncertainty in the tumour position due to movement or shrinkage. To allow for these~     uncertainties a large margin around the tumour is also treated, but this means that large~     volumes of normal tissue also receive significant doses of radiation, which can result in~     early and late toxicity.~      MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the~     difference between tumour and normal tissues and does not expose patients to additional~     radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear~     accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and~     the Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently~     installation a prototype, which will be one of the first in the world. This revolutionary~     technology has the potential to change the way radiotherapy is delivered. We hope the~     improved precision and accuracy in hitting the target will mean reductions in margins around~     tumours and that this will lead to higher cure rates with significantly fewer side effects.~     Studies are required to simulate treatment on the MR Linac before it can be used in routine~     clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers~     and patients who are currently undergoing treatment. This study will involve imaging with~     MRI in healthy volunteers as well as in patient volunteers before and during their standard~     course of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR~     Linac-based research focusing on clinical application and establishment into a MR-CT and MR~     only workflow, treatment adaptation and quality assurance.~   "
7169|NCT02963389|"~     This is an open-label, single ascending dose study to evaluate safety, tolerability, and~     pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma~     patients~   "
6376|NCT02973815|"~     The goal of the proposed project is to see if an innovative family-based intervention can~     reduce childhood obesity by actively engaging the whole family in promoting healthy~     behaviors in the home. In addition, the project will also examine how the NU-HOME family~     intervention influences children's dietary intake, availability of healthy and unhealthy~     foods in the home and served at meals and snacks, physical activity as a family, and child~     screen time (TV, game systems). The study will build upon a similar project conducted in an~     urban area and translate the lessons learned and adapt the program for a rural community.~   "
6377|NCT02973802|"~     Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with~     Graves Disease not currently treated with anti-thyroid therapy. This will be an open label~     dose titration involving injections on 10 occasions, each two weeks apart. After dosing is~     complete there will be a 12 week follow up period. Blood samples will be drawn throughout~     the study to monitor safety and the body's response to the injections. Thyroid function will~     be measured throughout the trial to monitor Graves disease progression.~   "
6378|NCT02973789|"~     The study is a prospective, randomized controlled phase III trial aimed to test the efficacy~     and safety of Tumor Treating Fields (TTFields) in combination with PD-1 inhibitors or~     docetaxel, for second line treatment of Non-small Cell Lung Cancer (NSCLC) .The device is an~     experimental, portable, battery operated device for chronic administration of alternating~     electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of~     surface, insulated electrode arrays.~   "
6379|NCT02973776|"~     Vasoconstriction study with LEO 90100~   "
6380|NCT02973763|"~     Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective~     Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant~     mutation tumor cell in Xenograft mouse model. This study aims at local advanced or~     metastatic non-small cell lung cancer patients with T790M drug-resistant mutation.~   "
6381|NCT02973750|"~     While significant progress has been made in the treatment and prognosis of ovarian cancer,~     this progress has mostly shown benefits for younger women.~      This study aims to understand two things: How body composition (the amount of muscle and~     water versus fat in in the body) affects the dose and side effects of chemotherapy; and the~     biological reason for the worse prognosis with aging. To get a good view of these effects,~     investigators are asking the help of both younger and older women for this project.~   "
6382|NCT02973737|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.~     This study is a randomized, multi-center, multinational, double blind, active-controlled,~     parallel design study of the combination of pyrotinib in combination with capecitabine~     versus placebo plus capecitabine in HER2+ MBC patients, who have prior received~     anthracyclin, taxane and trastuzumab.~      Patients will be randomized in a 2:1 ratio to one of the following treatment arms:~      Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo~     (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either~     arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or~     other specified withdrawal criterion.~      Patients in control group can be provide pyrotinib treatment when they progressed after the~     placebo plus capecitabine treatment.~   "
6383|NCT02973724|"~     The investigator designed this study to investigate remifentanil effect-site concentration~     in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol~     anesthesia.~   "
6384|NCT02973711|"~     This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in~     an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus~     allow for the deepest and most durable response possible in patients with CML in chronic~     phase who have achieved a complete hematologic remission (CHR), complete cytogenetic~     remission (CCyR), and major molecular remission (MMR), but not a complete molecular~     remission (CMR). The study will look at safety and tolerability of ruxolitinib when combined~     with nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose)~     of ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is~     established in the phase I setting, a phase II evaluation will seek to establish the~     efficacy of this combination.~   "
6385|NCT02973698|"~     Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy~     for Parkinson's disease (PD).~   "
6386|NCT02973685|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial~     infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in~     patients with large hepatocellular carcinoma staged BCLC A/B.~   "
6387|NCT02973672|"~     This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen~     (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the~     visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days~     before surgery and visualized using an optimized camera system.~   "
6388|NCT02973659|"~     Primary focal hyperhidrosis interferes with daily activities. Limited efficacy, costs, side~     effects and complications are issues of concern for most current therapeutic modalities. In~     this study the invetigators aim to evaluate the efficacy of topical oxybutynin 10% gel in~     treating primary focal hyperhidrosis. 60 patients with primary focal hyperhidrosis will be~     recruited. Topical oxybutynin 10% gel will be assigned to the right or left axilla, palm or~     sole and a placebo compound to the contralateral side for a total of 30 days. The~     Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI)~     questionnaires will be administered before and after treatment, and 2 noninvolved blinded~     physicians will score the results using starch-iodine tests. The participants will grade the~     sweat reduction on both sides and rated their satisfaction.~   "
6389|NCT02973646|"~     The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic~     hepatitis b patients with e antigen positive based on the detection of interferon gene~     mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.~   "
6434|NCT02973061|"~     Analysis of the short-and long-term impact of recombinant growth hormone on attention~     deficit and hyperactivity charachteristics in children and adolescents. This will be~     examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling~     validated questionnaires (Vanderbilt rating scales) evaluating ADHD.~      Data will be compared to healthy control group.~   "
6390|NCT02973633|"~     The development of symptomatic heart failure is frequently preceded by a pre-clinical period~     of structural remodeling in the heart. The remodeling process driving this transition,~     however, remains poorly understood. The investigators hypothesize that imaging the diffusion~     of water in the heart with MRI will allow its microstructure to be resolved. The~     investigators further hypothesize that the characterization of microstructural changes in~     the heart will help elucidate the pathogenesis of heart failure and the transition from a~     compensated to a decompensated state. Patients with recent myocardial infarcts and left~     ventricular hypertrophy, who are at risk for the development of heart failure, will be~     enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the~     heart to characterize changes in myocardial microstructure over time.~   "
6391|NCT02973620|"~     Open label study of levosimendan; planned comparison for effectiveness and safety to~     historic matched case controls from participating sites.~   "
6392|NCT02973607|"~     Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk~     of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly~     understood because CKD is always accompanied by confounding factors including the underlying~     disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD~     including hypertension, anaemia and inflammation.~      Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal~     study population to measure prospectively the effects of reduced kidney function on the~     cardiovascular system.~      The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse~     effects on cardiovascular structure and function at 12 months compared to controls including~     an increase in left ventricular mass. This proposal will measure the changes in~     cardiovascular structure and function, cardiovascular age and biochemical changes at 5 years~     providing information on the long term effects of reduced renal function.~   "
6393|NCT02973594|"~     Heart failure with reduced left ventricular ejection fraction (HFrEF) is the most common~     form of chronic heart failure in subjects ≤ 75 years of age. Beta-blocker therapy greatly~     reduces mortality and improves ventricular function in HFrEF patients, but 30-40% of~     patients do not show improvement in ventricular function with beta blockade.~      An extensive gene signaling network downstream from the beta1-adrenergic receptor, the~     primary target of beta-blocker therapy is likely important for development and progression~     HFrEF. Pathologic changes in this gene signaling network are only reversed towards normal~     levels when ventricular function improves. One potential mechanism for failure to improve~     ventricular function in HFrEF patients unresponsive to beta blocker therapy is a lack of~     heart rate reduction.~      Ivabradine is an FDA-approved medication believed to have therapeutic benefit in HFrEF~     patients through reduction in heart rate independent of beta-blockade. Ivabradine has been~     shown to reduce the risk of hospitalization for worsening HF in patients with stable,~     symptomatic chronic heart failure with reduced EF (≤ 35%)in sinus rhythm with resting heart~     rate ≥ 70 bpm and who are on maximally tolerated doses of beta blockers or who have a~     contraindication to beta blockers.~      Given the high rate of mortality and hospitalization of HFrEF patients even with current~     therapies, there is a large unmet need for improving HFrEF therapy. The goals of this study~     are to test the hypothesis that heart rate reduction is an important antecedent for~     improvement in ventricular function, and to identify components of the beta1-adrenergic~     receptor gene signaling network responsible for improvement in ventricular function caused~     by heart rate reduction.~   "
6394|NCT02973581|"~     The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for~     vitreoretineal surgery, presence of PONV and oculocardiac reflex and compare Numerical~     Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception~     postoperatively.~      Patients received general anaestesia alone or combined with either preemptive analgesia~     using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%~     lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive~     intravenous infusion of acetaminophen in a doseof 10-15mg/kg of body weight.~   "
6395|NCT02973568|"~     Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain~     care with a consultations rate in emergency center of more than 60%.For example~     OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.~      In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France~     (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of~     studies relative to chronic pain but not too much about acute pain in Spain.That's why we~     want to focus our study on evaluation of acute pain treatment and efficacy in french and~     spanish hospital~   "
6396|NCT02973555|"~     Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome~     of patients with thin endometrium undergoing ART treatments.~   "
6397|NCT02973542|"~     Abdominal pain remains the most deleterious symptom for patients with irritable bowel~     syndrome (IBS) and is causing a significant alteration of their quality of life. The~     visceral hypersensitivity seems to be one of the key mechanisms that could explain the~     abdominal pain in these patients. Current treatments, mainly symptomatic, are of limited~     effectiveness, especially in terms of relief of abdominal pain. The study will aim to~     evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its~     tolerance and its impact on patient quality of life, severity of symptoms related to IBS and~     the use of analgesics / antispasmodic / regulators transit.~   "
6398|NCT02973529|"~     Coronary artery disease is often treated by implantation of permanent metallic~     stents.Coronary stents are required in the early healing phase after balloon dilatation but~     constitute a lifelong foreign body. New bioresorbable stents have been developed and are~     believed to improve long-term safety. The purpose of this study is to compare the safety and~     vessel healing after treatment of simple bifurcation lesions with the CE-marked~     bioresorbable stents Absorb and Desolve.~   "
6399|NCT02973516|"~     This study is an exploratory study aiming to collect data about diagnosis efficacy~     (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with~     suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC~     confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology~     analysis. The standard of reference for diagnosis will be given by the site according to~     their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous~     contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site~     and/or the more recent AFP results available).~   "
6400|NCT02973503|"~     A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of~     Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV~     GT1b-Infected Patients, with non-severe fibrosis~      The primary objectives of this study are as follows:~        -  To evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks~          in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured~          by the proportion of subjects with sustained viral response 12 weeks after cessation of~          treatment (SVR 12).~        -  To evaluate the safety and tolerability of EBV/GZR treatment~      The secondary objectives of this study are as follows:~        -  To determine the proportion of subjects who attain SVR at 4 and 24 weeks after~          cessation of treatment (SVR4 and SVR24)~        -  To evaluate the proportion of subjects with virologic failure~        -  To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of~          treatment.~        -  To evaluate the emergence of viral resistance to EBV/GZR during treatment and after~          cessation of treatment~   "
6401|NCT02973490|"~     We design the clincal trial to investigate the efficacy of transanal tube drainage in~     colorectal ESD.~   "
6402|NCT02973477|"~     The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved~     diabetes medication, on measures of nervous system function of the heart in patients with~     type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active~     comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart~     rate variability and assess whether dapagliflozin has modulating effects on measures of~     nervous system function of the heart. This is a crossover study design where all~     participants will receive both study medications equally (12-week intervention periods) in a~     certain order.~   "
6403|NCT02973464|"~     This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of~     450mg daily begin within 10 days after renal transplantation, and till to Day 100~     posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the~     investigators divide these patients into three groups in random. One third will oral VGC~     450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third~     will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to~     oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal~     function for all agents.~   "
6404|NCT02973451|"~     to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site~     Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.~   "
6405|NCT02973438|"~     The purpose of this research is to examine changes in blood glucose control and metabolism~     in individuals with SCI and non injured controls at rest and during exercise after five days~     of exposure to IH. This response will be compared with breathing normal room air (a SHAM~     control).~   "
6406|NCT02973425|"~     Take a Break (TAB) is a randomized trial designed to evaluate NRT-sampling and a mHealth~     suite of apps. TAB is a time-limited self-efficacy and skills building experience for~     Motivation Phase smokers. TAB is designed to create a timeline within which motivation~     smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation~     Phase are relatively untapped in research available information. This project offers these~     smokers point-of-need technology support in the many components of the intervention.~   "
6407|NCT02973412|"~     The aim of this study is to explore the associations between chronotype and glycaemic~     control, cardiometabolic health and other lifestyle factors.~   "
6408|NCT02973399|"~     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of~     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome~     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the~     addition of SNX-5422 to an established dose of ibrutinib will provide clinical response in~     subjects who have residual disease, but have not progressed on ibrutinib after 18 months of~     monotherapy, and/or prevents or delays disease progression of subjects with CLL.~   "
6409|NCT02973386|"~     This is a randomized,controlled,prospective phase III clinical trial. The purpose of this~     study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with~     or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma~     at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan~     which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques~     for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.~   "
6410|NCT02973373|"~     The purpose of the study is to evaluate the benefit on image quality of MRI of the chest~     performed under high frequency non-invasive ventilation. This technique indeed allows to~     generate an apnea duration of several minutes with acquisitions performed at full~     inspiration. This study will be applied on healthy subjects.~   "
6411|NCT02973360|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,~     dose-finding study of SC411 in children with sickle cell disease (SCD). The primary~     objective of the study is to evaluate the safety and tolerability of three different doses~     of SC411 compared to a placebo. All patients will undergo eight weeks of oral study~     treatment and a four-week safety follow-up period. Patients will be randomized to one of~     three dose levels of SC411 or placebo.~   "
6412|NCT02973347|"~     Mechanical ventilation has become one of the most important supportive treatment methods to~     save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is~     a common complication of mechanical ventilation. It is one of the leading causes of~     hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate~     patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is~     associated with significant increased mortality. In those critical ill patients, the~     catabolism increased, the anabolism decreased, which can induce negative nitrogen balance.~     The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific,~     released in 2014, clearly recommended that early enteral nutrition support, which begin~     within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and~     mortality of nosocomial infection. Intermittent enteral feeding and continual enteral~     feeding are the most common methods of enteral nutrition at present. There is no final~     conclusion about the association between enteral nutrition methods and VAP. Thus, the~     relationship between enteral feeding and VAP has long been a controversial issue. There is~     little clinical research on the correlation between enteral nutrition and VAP in children~     with mechanical ventilation, and mostly were observational studies which lacks strong~     evidence. How to choose the appropriate enteral nutrition remains an urgent need in PICU~     clinical work. Therefore, it is necessary for us to analyze the relationship between enteral~     feeding and VAP in critically ill children. This study would perform a two-year research~     with mechanical ventilated patients in PICU of four children hospitals in Shanghai, which~     aim to determine the relationship between different enteral feeding methods and VAP, to~     collect the baseline characteristic data of ventilated children, to analyze the risk factors~     for VAP in PICU patients. The results from our study would contribute to improving the~     standard of care for children undergoing mechanical ventilation, reducing their lung injury~     and improving prognosis.~   "
6414|NCT02973321|"~     Primary Objective:~      The primary objective of this study is to assess the dose-response relationship of SAR425899~     versus placebo in terms of glycemic control as measured by the change in glycosylated~     hemoglobin (HbA1c).~      Secondary Objectives:~        -  To assess the effect of SAR425899 on body weight.~        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of~          the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.~        -  To assess the proportion of patients achieving predefined HbA1c targets of <7% and~          <6.5% as well as the proportion of patients achieving ≥5% and ≥10% body weight loss.~        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of~          glycemic control and lipid metabolism.~        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic~          (PD) biomarkers.~        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899,~          inter-individual and inter-occasion variability in PK parameters using a population PK~          approach.~   "
6415|NCT02973308|"~     Exercise testing is commonly being used in patients before surgery to test their overall~     fitness. One group it is being used in is patients who have an enlarged blood vessel in~     their stomach. This is known as an abdominal aortic aneurysm. The exercise test used is~     known as a cardiopulmonary exercise test as it looks at both heart and lung function at the~     same time. Whilst this test is commonly used there have been no studies (to date) which have~     looked at how reliable this test is; this means how well the investigators can obtain the~     same (or very similar) results after multiple tests. The investigators would like to test~     this reliability both between patients and the clinicians performing the testing.~   "
6416|NCT02973295|"~     This study evaluates the influence of Silymarin in reducing laboratory, ultrasonographic~     (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive Silymarin~     (Verum) while the other half will receive placebo~   "
6417|NCT02973282|"~     The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software~     application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,~     asthma, croup, upper or lower respiratory tract infections) in infants and children.~     Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx~     software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical~     diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.~   "
6418|NCT02973269|"~     The specific aim of the study is to compare the safety and efficacy of a single~     administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar~     fasciitis.~   "
6419|NCT02973256|"~     Meningiomas with malignant components include grade II meningiomas (GIIM, the most common~     ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.~     Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as~     being quite subjective. Standards of care and consensus do not exist for GIIM,~     particularly in regards to performing, or not, radiotherapy after surgery. One other~     limitation in the literature is lack of data on health-related quality of life (HRQoL).~     Clinical trials for GIIM are very difficult to conduct. No results have been made available.~     Here, we propose to study clinical, pathological, radiological and therapeutic factors of an~     exhaustive population of GIIM and GIIIM patients, at national level. The main objective (for~     GIIM) is to assess the impact of postoperative radiotherapy, or the absence of postoperative~     radiotherapy, on overall survival and on quality of life~   "
6420|NCT02973243|"~     To evaluate the effect of automated recording on frequency of recorded scores, number of~     automated notifications and serious events.~   "
6421|NCT02973230|"~     The aim of the present study was (i) to evaluate whether a single measurement of VEGF would~     allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii)~     to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each~     subgroup.~      Ninety patients were selected from a population of women presenting to the Hospital das~     Clínicas of the University of São Paulo Medical School from October 2006 until September~     2007 and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy~     (defined as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a~     embryo greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence~     of intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels~     in 48 hours); all tubal pregnancies were surgically treated and were histologically~     confirmed, they did not receive any methotrexate treatment before operation; (iii) normal~     intrauterine pregnancy (intrauterine gestational sac, embryo vitality confirmed).~      Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL~     of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF~     determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed~     to coagulate at room temperature for 2-6 hours.~   "
6422|NCT02973217|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size.~      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction~     of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is~     also to investigate the functionality and safety as well as understanding of the subsequent~     immunological effects.~      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic~     cancer will be treated in this trial, which is estimated to be carried out during a time~     period of 36 months.~   "
6435|NCT02973048|"~     Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia~     using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite~     effective surgical anesthesia, bupivacaine is associated with long duration motor block and~     dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its~     new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and~     faster regression of motor block compared to other local anesthetics without noteworthy~     side-effects when used intrathecally. The aim of this randomized, multicenter, powered~     clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric~     bupivacaine for scheduled caesarean delivery under spinal anesthesia.~   "
6423|NCT02973204|"~     Background Treatment and control of cancer is associated with high costs, to patients in the~     form of side effects and discomfort during investigations, to society in the form of~     expensive drugs and studies.~      Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying~     to estimate future course in patients with breast cancer, colon cancer and prostate cancer.~     CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise~     to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to~     the analysis of the CTC.~      The investigators would like to with molecular biological methods predict which patients~     requires special monitoring and individualized therapy and explore these tests as clinical~     decision support.~      Purpose and method~      In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular~     carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA~     sequencing and digital polymerase chain reaction (PCR):~        1. Identify and isolate the CTC and investigate these for tumor-specific mutations.~        2. Quantify ctDNA and analyze this for specific mutations, which in the past has been~          found frequent in NET and HCC.~        3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies.~      The results are compared with the clinical data on disease course, including the effect of~     treatment and survival.~      Subjects 40 Patients with small intestinal/unknown primary NET before treatment with~     somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30~     patients with presumed radically treated HCC 30 patients with HCC in treatment with~     Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after~     start of treatment and thereafter every 3.-6. month for up to two years.~      Perspectives In several cancer types molecular diagnostics have had significant influence in~     treatment and control strategy. The goal is in future to be able to take advantage of a~     so-called liquid biopsy as clinical decision support. The study will bring new knowledge~     to this growing field of research.~   "
6424|NCT02973191|"~     This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and~     safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two~     sequential parts, Part A and Part B; subjects will be screened and will provide informed~     consent before initiating any study procedures in Part A of the study.~   "
6425|NCT02973178|"~     This study will test Scanadu Urine Device for clinical performance and usability.~   "
6426|NCT02973165|"~     Objectives: Mild traumatic brain injury (mild TBI) occurs frequently in combat personnel and~     has been linked to complaints of emotional symptoms in up to 85% of those injured, with high~     rates of PTSD symptoms, anxiety, depression, and mood swings. TBI may cause cerebral white~     matter injury and changes in white matter integrity have been correlated with behavioral~     changes even with very mild TBI. Patients with mild TBI also have higher rates of~     dishonorable discharge from the military, as well as substance abuse. Many of these~     behavioral changes are associated with alterations in frontal-subcortical networks, which~     are heavily dependent on white matter connectivity. Our primary goal in this investigation~     is to begin to understand the specific neurological mechanisms that may underlie emotional~     dysfunction following mild TBI.~      Research Plan: We will compare patients with PTSD but no TBI to patients with TBI with and~     without emotional symptoms. It may be that the basic emotional responses of these~     populations are different and that these differences may help elucidate the mechanism~     accounting for these changes in mood and emotional behaviors. Finding a neurological and~     injury-specific basis for the constellation of chronic emotional symptoms observed in this~     population could have treatment implications such that the treatment of patients with versus~     those without injury induced PTSD may have different efficacies (e.g., exposure therapy may~     work best for the patients with non-injury related PTSD).~      Methods: We will recruit 60 subjects with mild TBI from our OEF/OIF poly-traumatic and 60~     controls (30 with PTSD but no TBI). We will test emotional behaviors using an affective~     neuroscience methodology with indicators chosen based on the reported symptoms profiles in~     this population. Specifically, we will assess the relationship between white matter injury~     in the uncinate fasciculus and anterior limb of the internal capsule and alteration of~     affective response physiology (e.g., startle response while viewing high intensity~     positively and negatively valecned visual scenes) and cognitively (identification of the 6~     primary emotions including ratings of intensity and arousal). To determine the integrity of~     white matter pathways, we will use high-resolution diffusion weighted imaging (DWI) with~     diffusion tensor imaging (DTI) and related analysis techniques.~   "
6427|NCT02973152|"~     The purpose of this study is to help determine the most effective treatment for participants~     with Unilateral Vocal Fold Paralysis.~      There are currently two types of operations used to treat this condition. One operation is~     called thyroplasty. Doctors place a small piece of safe plastic into the side of the~     participant's voice box to push the weak vocal cord into a position to enable better speech~     and swallowing. In the other operation called laryngeal reinnervation, doctors repair the~     neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better~     speech and swallowing. The investigators do not know which of these methods is better and~     are conducting this study to start comparing the two operations so that a larger clinical~     trial can be conducted in the future to tell us which operation is best.~   "
6428|NCT02973139|"~     The purpose of this prospective randomized clinical trial is to compare two currently~     accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to~     instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant~     Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion~     (CPPE) in adults.~   "
6429|NCT02973126|"~     The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in~     identifying vessel-specific, hemodynamically significant CAD in patients scheduled for~     invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In~     particular, the study will evaluate the ability of FFRct to correctly rule out~     hemodynamically significant CAD in patients with non-significant CAD or normal coronary~     arteries who had positive SPECT scans.~   "
6430|NCT02973113|"~     Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or~     lymphoproliferative disease (LPD), which affects their immunity, blood production, and can~     involve multiple other organs in the body. Their disease has come back or has not gone away~     after treatment. The experimental treatment plan consists of an antibody therapy called~     Nivolumab that helps the subjects' T-cells control the tumor, and special immune system~     cells called LMP-specific cytotoxic T lymphocytes, also a new therapy whose side effects are~     well studied.~      Some patients with NHL or LPD are infected with the virus that causes infectious~     mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis.~     The cancer cells that are infected by EBV are able to hide from the body's immune system and~     escape destruction. Investigators want to see if special white blood cells, called T cells,~     that have been trained to kill cells infected by EBV can survive in the blood and affect the~     tumor.~      Investigators have used this sort of therapy to treat a different type of cancer that occurs~     after bone marrow or solid organ transplant called post-transplant lymphoma with good~     success. These cells are called LMP-specific cytotoxic T-lymphocytes (EB-VSTs), and are~     effective in treating these diseases. These LMP-specific EB-VSTs are experimental and not~     yet approved by the Food and Drug Administration (FDA).~      Sometimes it is not possible to grow these cells; or they may not last very long in the body~     after being given into the vein thereby having only limited time to fight the tumor. With~     this study, investigators aim to increase the duration of time that the T cells can last in~     the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved~     for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma.~      The purpose of this study is to find out if LMP-specific EB-VST cells in combination with~     nivolumab is safe, to learn what the side effects are, and to see whether this therapy may~     help patients with EBV related lymphoma or LPD.~   "
6431|NCT02973100|"~     The purpose of this study is to evaluate the efficacy and safety of investigational doses of~     dulaglutide in participants with type 2 diabetes on metformin monotherapy.~   "
6432|NCT02973087|"~     The purpose of this phase 3 study is to investigate the efficacy and safety, including~     immunogenicity and thrombogenicity of prophylactic treatment with recombinant von Willebrand~     factor (rVWF) in subjects with severe von Willebrand disease (VWD).~   "
6433|NCT02973074|"~     The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in~     the course of Patient Blood Management in preparation for orthopedic surgery.~   "
6436|NCT02973035|"~     Hypertensive patients are at increased risk of developing LV hypertrophy and myocardial~     fibrosis, which cause diastolic dysfunction. Because the activation of~     rennin-angiotensin-aldosterone system (RAAS) has been shown to induce LV hypertrophy and~     myocardial fibrosis, the RAAS may play a central role in the pathogenic process from~     hypertension to diastolic HF. Inhibitors of RAAS have been considered as a treatment option~     for these patients, and the angiotensin receptor blockers (ARB) have been of interest~     because they antagonize the effects of angiotensin II more completely. However, the~     Irbesartan in Heart Failure with Preserved Systolic Function (I-PRESERVE) trial reported~     that treatment with irbesartan did not reduce the risk of death or hospitalization for~     cardiovascular causes among 4,128 patients who had HF with a preserved LV ejection fraction.~     The degree of improvement of diastolic dysfunction was associated with the extent of~     systolic blood pressure reduction, whether a RAAS inhibitor or non-RAAS blood pressure~     lowering was used. Amlodipine is a potent and well-tolerated calcium channel blocker, and~     seems to be appropriate for achieving more aggressive systolic blood pressure target and~     improving diastolic dysfunction in hypertensive patients, because amlodipine is clinically~     very useful for controlling systolic blood pressure. Assessment of diastolic function by~     echocardiography will be helpful to determine whether addition of amlodipine or an ARB to~     standard therapy is more beneficial to hypertensive patients with diastolic dysfunction. The~     investigators hypothesize that amlodipine added to standard therapy will be superior to~     valsartan in improving diastolic dysfunction by lowering systolic blood pressure more~     effectively in hypertensive patients, and try to examine this hypothesis in a prospective,~     open-label, randomized comparison study using blinded echocardiographic evaluation for end~     point.~   "
6437|NCT02973022|"~     The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple~     (CC&S) educational sessions on cancer prevention and screening. The researchers will recruit~     60 community members: 30 will receive CC&S training (intervention group) and 30 will not~     (control group). All 60 will be surveyed about their intent to change their behavior at the~     beginning of the study and their actual behavior changes and their screening behavior 6~     months after enrollment in the study.~   "
6438|NCT02973009|"~     The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic~     booming in recent years.~      This is an effective intervention on weight loss over the long term with few early~     postoperative complications and low morbidity in the long term.~      Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a~     relative risk of 29% in connection with cholecystectomy.~      Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical~     evaluation.~      Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric~     bypass with a rupture rate increased on epigastric trocar. The assessment in the context of~     this series was ultrasound.~      Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an~     SG of first intention was associated with a hernia rate of 17% with a scannographic~     evaluation.~      Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site~     would not be as effective as lateralize inserting the trocar from the white line of the~     abdomen. Change the positioning of this trocar induce an additional difficulty in handling~     instruments for the realization of the SG with an désaxassion instruments, a conflict~     between the instruments for the realization of the SG and the optical laparoscopy.~   "
6439|NCT02972996|"~     Lifestyle strategies that include dietary modification, such as consumption of a plant-based~     diet, are well recognized in disease prevention and may improve type 2 diabetes. Various~     components of a plant-based diet may contribute to its beneficial health effects, but there~     has been keen interest in the possibility that plant polyphenols may have a role.~     Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are~     few human clinical trials evaluating the beneficial health effects of blueberries in~     populations with type 2 diabetes. The objective of the study is to determine if freeze-dried~     blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men~     with type 2 diabetes.~   "
6440|NCT02972983|"~     The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in~     combination with a beta lactam antibiotic on treating bloodstream infection caused by~     methicillin-susceptible S. aureus.~   "
6441|NCT02972970|"~     Feasibility study to assess the scan, fit and print process for the Aveera Patient Matched~     CPAP Mask~   "
6442|NCT02972957|"~     The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given~     into the nose and in early studies was shown to be better than the standard influenza~     vaccine at preventing infections in children. However, more recently, it has performed less~     well and it may also work less well in Sub-Saharan Africa. Not only do the investigators not~     know why this is, but the investigators also do not fully understand why LAIV produces~     stronger nasal antibody responses in some individuals but not others. Usually harmless~     bacteria that are present in participants noses can influence how our immune system works~     and variations in these may explain differences in how LAIV works. The project will recruit~     children given LAIV in the Gambia to gain further understanding of these issues.~      The investigators will measure a variety of responses to LAIV, including genes that can~     change their expression early after vaccination and use advanced computational techniques to~     identify new relationships between these genes and other LAIV responses. The investigators~     will also see whether nasal bacterial profiles in children who respond to LAIV are different~     from those who do not. In addition, the investigators will alter these bacteria in a subset~     of children with antibiotics and see whether this affects both nasal gene expression and~     later responses to LAIV.~   "
6443|NCT02972944|"~     Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute~     calculous cholecystitis.The purpose of this study is to find the most effective treatment~     (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute~     cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering~     from acute cholecystitis is performed.~   "
6444|NCT02972931|"~     The main purpose of this study is to unravel the mechanisms by which the Low Viral~     Reservoir Treated patients (LoViReT) maintain extremely low HIV-1 DNA levels despite having~     initiated cART during chronic HIV-1 infection. This group may have specific and different~     clinical, virological and immunogenetical characteristics, compared to patients with regular~     reservoir size, which might be useful to design new and more effective treatment approaches.~   "
6445|NCT02972918|"~     The purpose of this study is to evaluate whether preoperative optimization with levosimendan~     in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue~     perfusion parameters.~   "
6457|NCT02972697|"~     Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis~     (TB) may be able to detect non-replicating persister bacilli. This may permit identification~     of those patients at risk of relapse following completion of TB treatment. The main aim of~     this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in~     individuals with active pulmonary TB.~   "
6446|NCT02972905|"~     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta~     inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment~     of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The~     purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of~     single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI)~     to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557~     will be administered via the ELLIPTA DPI with the addition of magnesium stearate.~      In each group of this study, subjects will receive a single dose of either GSK2269557 or~     placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session~     2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the~     previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700~     mcg. There will be at least 10 days washout between the two dosing sessions. Follow up~     period will start 10 days (+-1 day) after the last dose of Session 2. A total number of 36~     subjects will be enrolled for the study with 27 subjects receiving a dose strength of~     GSK2269557 and 9 subjects will receive each dose strength of GSK2269557. ELLIPTA is a~     trademark of the GSK group of companies.~   "
6447|NCT02972827|"~     Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards~     FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in~     sepsis and septic shock.~   "
6448|NCT02972814|"~     The investigators prospectively want to compare 3 clinical tests for measuring blood~     troponin levels in patients presenting to the emergency room with thoracic pain probably~     related to a myocardial infarction with regard to the time necessary to obtain the test~     results.~      The tests are one laboratory based test and two point of care tests.~   "
6449|NCT02972801|"~     Testicular tissue cryopreservation is an experimental procedure where a young boy's~     testicular tissue is retrieved and frozen. This technique is reserved for young male~     patients who are not yet producing mature sperm, with the ultimate goal that their tissue~     may be used in the future to restore fertility when experimental techniques emerge from the~     research pipeline.~   "
6450|NCT02972788|"~     The purpose of the study is to determine the effect of enamel matrix protein derivative on~     an inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix~     derivative protein with increase the clinical attachment level is localized sites of~     advanced periodontal disease.~   "
6451|NCT02972775|"~     The investigators examine the 15-year mortality after an admission for an exacerbation of~     Chronic Obstructive Pulmonary disease (COPD).~   "
6452|NCT02972762|"~     The investigators,according to the eligibility criteria,plane to choose 80 elderly~     anticipates who will undergo selective hip replacement surgery.This participants will be~     randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia~     depth group (D Group).Before anesthesia induction,each participant will be given lumbar~     plexus and sciatic nerve block in order to control pain of interoperative and~     postoperative.During operation period,the L Group will be kept in light anesthesia~     depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS~     values in the range of 30-60 have been recommended in general anesthesia.After operation,a~     PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each~     participant to control postoperative pain. The investigator will evaluate the mental state~     of participant with MMSE(mini-mental state examination) before surgery and review each~     participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation~     delirium.intraoperative awareness,postoperative pain will also be investigated in~     postoperative days 1, 2, 3.~   "
6453|NCT02972749|"~     There is growing awareness that environmental factors, behaviors and diet are intimately~     related to patient health and may play a role in the pathogenesis and progression of~     glaucoma. Evidence from recent years has shown that some behaviors and environmental factors~     can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims~     to investigate whether simple and common lifestyle inteventions such as sleeping with a head~     elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake~     could affect intraocular pressure and other outcomes.~   "
6454|NCT02972736|"~     Retrospective multicenter study aimed to evaluate radiation exposure associated with~     different interventional procedures involving interventional cardiologists, interventional~     radiologists and electrophysiologists.~   "
6455|NCT02972723|"~     Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease~     worldwide. Current therapy for HCV with interferon based therapies results in cure rates of~     around 5055% which leaves a significant number of patients without effective therapy. HCV~     induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce~     the response to antiHCV therapy. This finding stimulated initial studies looking at agents~     that may reduce insulin resistance as additional therapy in HCV infection.~      A study using metformin in addition to interferon and ribavirin showed a nonsignificant~     increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection~     AND demonstrable insulin resistance. The assumption was made that the potential effect of~     metformin was likely to be on insulin resistance and thus by modulating this enhances~     response. The investigators (Prof M Harris, University of Leeds) have data (currently~     unpublished)suggesting that metformin may have an antiviral effect independent of its effect~     on insulin resistance, thus raising the possibility that metformin may have a direct~     antiviral effect in vivo. Given that the development of specific antiHCV agents which target~     viral proteins such as its polymerase and protease are in trial development but have so far~     proved either highly toxic or are likely to have a huge cost there is considerable rationale~     for looking at alternative potential antiHCV agents and in this context metformin is cheap,~     readily available and has an excellent safety profile. This pilot study therefore addresses~     the question Does metformin therapy result in a significant drop in HCV viral load in~     chronically infected patients?~   "
6456|NCT02972710|"~     The purpose of this study is to compare the short-term effects of two different thoracic~     spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported~     disability in individuals experiencing neck pain.~   "
6477|NCT02972437|"~     The investigators intend to screen children who are suspected of having GAS tonsillitis.~     From each child we will take a throat culture and saliva sample to screen for molecular~     evidence of GAS.~   "
6458|NCT02972684|"~     Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of~     cardiac surgical interventions.~      Treatment of such complication often necessitates various combinations therapeutic~     intervention including allogenic blood products administration, drug use and/or surgical~     intervention. All are expensive treatment and decision making is guided by patient clinical~     status and biological tests of the haemostatic function.~      A key point is the time frame of the clinical process. Therapeutic choices have to be done~     as fast as possible to minimize bleeding consequences on patient haemodynamic and~     physiological status. Conventional coagulation test results availability time usually exceed~     45' after blood drawing. In such situation, the results may not reflect precisely the~     coagulation system current state. This downside is often counterbalanced by clinicians~     empirical choices preceding lab test results knowledge that may conduct to inappropriate~     treatment, blood product overuse and undue expense.~      Viscoelastic point of care test may compensate for the limitations of conventional~     coagulation tests. In perioperative haemorrhage, faster and more precise information about~     haemostatic function may help for more accurate therapeutic choices.~      The IMOTEC study aims to compare haemorrhage management following cardiac surgery using~     conventional blood coagulation tests or thrombo-elastogaphic point of care test.~      Primary endpoint is a cost utility analysis of the technology and secondary endpoints~     include blood component transfusion, postoperative bleeding , thoracic re-intervention,~     postoperative infection (any cause), organ failure, in hospital length of stay and death.~   "
6459|NCT02972671|"~     To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF)~     at 12 months in a non-inferiority trial in a real world patient population and to confirm~     that the domestic extrapolation of the DESSOLVE III study results is valid.~   "
6460|NCT02972658|"~     This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The~     purpose of this study is to evaluate the effectiveness of the study drug LY3314814 in~     participants with early Alzheimer's disease dementia at the time of entry into study~     I8D-MC-AZES.~   "
6461|NCT02972645|"~     The purpose of this study is to evaluate the safety of LY3305677 and any side effects that~     might be associated with it.~      This study will also look at how much LY3305677 gets into the blood stream, how long it~     takes the body to remove it.~      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).~      Participation in this study is expected to last up to 16 weeks.~   "
6462|NCT02972632|"~     The purpose of this study is to determine the effectiveness of treatment with vortioxetine~     on participant goal achievement after a change in antidepressant medication for the~     treatment of major depressive disorder (MDD).~   "
6463|NCT02972619|"~     Background: Hypertension is a serious public health problem responsible for significant~     mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30~     years or older suffer from hypertension. Nearly half of these patients have uncontrolled~     hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims~     to evaluate the effectiveness, cost effectiveness and impact on medication adherence of a~     well-structured program using multicomponent intervention for hypertension control aimed at~     overall cardiovascular risk reduction among individuals with hypertension attending the~     polyclinics in Singapore, compared to existing services. Such a program is expected to be~     cost-effective in terms of improving hypertensive individuals' outcomes, and to be~     potentially scalable and sustainable.~      Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized~     to intervention or usual care (4 each) and followed up for 2 years post randomization~      Intervention: The structured multicomponent primary care program comprises of: 1)~     algorithm-driven antihypertensive treatment for all hypertensive individuals and using~     fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive~     individuals, 2) motivational conversation for high-risk hypertensive individuals, 3)~     Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary~     outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on~     FDC antihypertensive medication~      Usual care: The participants attending polyclinics randomized to usual care will continue to~     receive treatment from the health providers according to existing practices. The~     hypertensive individuals will also continue to pay for the services (physician or nurse~     consultation) as per their existing model of reimbursement.~      Participants: A total of 1000 participants will be recruited, 125 from each of the 8~     polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by~     randomization group).~      Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors~     independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary~     outcome will be the change in systolic blood pressure from baseline to 2 years. Primary~     Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction~     from baseline to end of follow-up at two years post randomization; 2) incremental cost per~     projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years~     (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline~     to final follow-up at two-year post. The impact of effect on adherence to antihypertensive~     and lipid medication will be measured using data on adherence obtained from polyclinic~     pharmacy records and clinic notes. An average of percent adherence to antihypertensive and~     lipid lowering will be computed as a composite score. The change in percent composite~     adherence to antihypertensive and lipid medications from baseline to follow up will be~     compared between the intervention and control groups.~   "
6464|NCT02972606|"~     Presently, there are few options for medically managing HIV-related painful peripheral~     sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural~     Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN.~     However, there is a scarcity of research on psychological treatment approaches for pain~     management in people with HIV. This study will use in-depth semi-structured interviews to~     examine the needs of people with painful HIV-SN for a psychologically-based pain management~     treatment that may be delivered over the Internet. Interview questions will examine~     participants' needs in terms of treatment content and delivery format. Men and women, ethnic~     minorities, and people who use recreational drugs will be sampled to ensure that interview~     responses reflect the views of people most commonly suffering from this condition.~     Approximately 30 people will be recruited for the study. The interviews will be audio~     recorded, transcribed verbatim, and coded to identify themes. The interview responses will~     be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped~     that tailoring the treatment based on the qualitative interview responses will increase the~     acceptability of the treatment and will improve treatment adherence rates for a future~     study.~   "
6465|NCT02972593|"~     The purpose of this study is to determine if there is a difference in outcomes between~     liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and~     conservative transfusion (transfusing when hemoglobin drops below a set lower value number).~   "
6466|NCT02972580|"~     Longitudinal prospective observational study. This is a 24-month study with the possibility~     of extending the data time points. Initially baseline, then 12 and 24 months follow up~     studies will be completed.~   "
6467|NCT02972567|"~     The purpose of this study is the evaluation of the effects in obese patients with metabolic~     syndrome on the composition of the intestinal microbiota, markers of the syndrome~     (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic~     steatosis) and other possible metabolites involved.~   "
7186|NCT02963168|"~     This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to~     determine the MTD and optimal dosing regimen of Oradoxel. No control group has been~     included.~   "
6468|NCT02972554|"~     This randomized, double-blind, placebo-controlled study of propranolol will shed important~     light on how sympathetic nervous system (SNS) activation influences our psychological and~     inflammatory responses to acute stress. Results from this study will inform both the basic~     science literature that is attempting to map the physiological mechanisms by which~     psychological stress may lead to poor mental and physical health, and may also ultimately~     have therapeutic relevance for individuals who are experiencing high levels of stress that~     is putting their health at risk. By utilizing psychopharmacological approaches, the~     investigators will circumvent many of the challenges of conducting this research in human~     populations. The investigators will also be in a place to draw strong conclusions regarding~     causality, given that they will have experimentally manipulated SNS activation, rather than~     relying on correlational measures of SNS activity that are difficult to assess and are not~     appropriate for asking if SNS activity causes changes in psychology and biology.~   "
6469|NCT02972541|"~     Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with~     colorectal cancer present with an emergency obstruction of the large bowel at the time of~     diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients~     with obstruction are associated with worse oncologic outcomes compared with those having~     nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction~     receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and~     about two-thirds of such patients end up with a permanent stoma.~      Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve~     obstruction prior to elective surgery) in patients with potentially resectable colorectal~     cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior~     to emergency surgery considering the short-term outcomes. SEMS is associated with lower~     morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma~     creation rate. Although about half of patients can achieve primary anastomosis after stent~     placement, the primary anastomosis rate is still significantly lower compared with~     nonobstructing elective surgery. The interval between stent placement and surgery may be not~     long enough that bowel decompression is insufficient at the time of operation.~     Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still~     limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with~     SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was~     significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One~     interpretation is that tumor cells may disseminate during the procedure of colonic stenting~     placement. We hypothesis that immediate chemotherapy after stenting may improve overall~     survival by eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the~     interval between stent placement and surgery, and the time for bowel decompression is more~     sufficient, which may increase the success rate of primary anastomosis and decrease risk of~     stoma formation.~   "
6470|NCT02972528|"~     Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed~     with Diabetic Foot Ulcer (DFU).~   "
6471|NCT02972515|"~     Tobacco use among women now approaches that of men, with approximately 27 million women~     smokers in the United States alone. Women report greater difficulties quitting smoking and~     are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary~     practices and lack of physical activity, with 92% of smokers reporting at least one other~     health risk factor. Concerns surrounding weight gain, negative body image, and low~     self-efficacy, may be key factors affecting smoking cessation among weight-concerned women~     smokers. Guided imagery has been successfully employed in separate lines of inquiry to~     address physical activity, diet and smoking cessation. However, guided imagery has not been~     employed to target weight concerned women who smoke or to simultaneously target smoking,~     diet, and exercise behavior in a single intervention. The proposed study would be the first~     of its kind to create a theory-based, guided imagery intervention to assist weight-concerned~     women smokers to quit. The use of a mobile app offers an innovative approach to addressing~     the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and~     has the potential to reach large numbers of women smokers. The project aims to develop and~     test the feasibility of a mobile health application using guided imagery in order to~     increase smoking cessation among a population of weight-concerned women smokers.~   "
6472|NCT02972502|"~     Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency~     department (ED).In this study the investigators seek to explore another option for treatment~     of headaches in the ED, one that may be more efficacious and efficient. Haloperidol~     (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2~     receptor in the brain.~      By exploring haloperidol as an option for treatment, the investigators hope to discover a~     more efficient and effective medication for the treatment of non-traumatic headaches,~     thereby decreasing a patient's length of stay in the department and decreasing the rate of~     return visits for continued discomfort from the same headache. This study could lead to the~     increased usage of haloperidol as a first line agent in the treatment of prolonged headaches~     presenting to the ED.~   "
6473|NCT02972489|"~     The primary purpose of this study is to determine whether bifurcation stenting guided by~     on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that~     with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation~     segment.~   "
6474|NCT02972476|"~     A randomised controlled trial to test the hypothesis that inhaled therapies for chronic~     obstructive pulmonary disease (COPD) have differential effects on the upper airway~     microbiome.~      COPD is the third leading cause of death worldwide. Exacerbations drive disease progression~     and worsening quality of life and therefore prevention of exacerbations has been a major~     goal of treatment.~      Patients with COPD are frequently prescribed inhaled corticosteroids (ICS) which have been~     shown to reduce exacerbations in combination with long acting beta2-adrenoceptor agonists~     (LABA). In recent years, all ICS preparations have been associated with a significant~     increased risk of pneumonia in either randomised trials or observational studies leading to~     warnings from national regulatory authorities and leading experts. This has led to a~     re-evaluation of the role of ICS in COPD treatments. It is likely that the risk of pneumonia~     is not equal across all ICS doses and molecules.~      There is a compelling rationale for ICS having a strong effect on the upper airway~     microbiome, and that this may be one mechanism of increased pneumonia risk with these drugs.~     The existing literature regarding ICS and pneumonia risk are lacking; 1) there are no head~     to head trials comparing different ICS preparations and 2) the comparator in these studies~     to date have been long acting beta2-adrenoceptor agonists alone, whereas the most~     appropriate comparator in current management would be combined LABA and long-acting~     muscarinic antagonist (LAMA).~      The MUSIC TRIAL is a multi-centre randomised open label controlled parallel group study with~     four treatment arms and a total of 120 participants. Severe COPD patients currently treated~     with inhaled corticosteroid therapy will be randomised to treatment with one of three~     preparations of ICS in combination with LABA or the control arm of dual bronchodilator~     therapy following a four week washout period. Participants will return monthly to determine~     if there are changes in the microbiome in their upper airway.~      This study will establish one potential mechanism for the increased susceptibility to~     pneumonia in ICS users and assess intraclass differences in ICS molecules and the effect of~     ICS dose on the microbiome. Demonstrating that different COPD treatments can have different~     effects on the lung microbiome is an important step in understanding clinical differences in~     the safety and effectiveness of different treatments for severe COPD.~   "
6475|NCT02972463|"~     The purpose of this study is to determine the optimal dose of IgY as assessed by changes in~     the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut~     microbiome as assessed by 16s RNA sequencing of fecal samples.~   "
6476|NCT02972450|"~     EVHA T01 is a Phase IIb randomised therapeutic HIV vaccine trial in individuals who started~     antiretrovirals during primary or chronic infection. HIV+ participants will be randomised to~     receive active vaccine or placebo.~   "
6478|NCT02972424|"~     In the proposed trial the investigators will recruit women and men >65 years of age with~     acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of~     treatment in a placebo controlled double blind study to determine if standard care and~     teriparatide 20 mcg/day versus placebo for pelvic fractures:~        1. Results in earlier evidence of cortical bridging on routine radiographs followed by~          confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans~          (primary outcome).~        2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a~          reduction in the use of narcotics (secondary outcome).~        3. Leads more rapidly to improved functional outcome using a short physical performance~          battery to assess lower extremity function (secondary outcome).~   "
6479|NCT02972411|"~     This study evaluates the safety and efficacy of the voluntary ventilatory response as~     prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score,~     comparing to a group using acetazolamide.~   "
6480|NCT02972398|"~     The aim of this study is to evaluate the efficacy of N-acetylcysteine (NAC) add-on to~     antidepressant medication in treating patients who do not relieve during standard~     antidepressant treatment for 6 weeks at least. Meanwhile, secondary outcomes will include~     changes in some biomarkers and on specifically local brain activity (functional Magnetic~     Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). The~     hypothesis of this study is that NAC has positive effects on refractory major depressive~     disorder patients with increased inflammatory activity.~   "
6481|NCT02972385|"~     Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important~     to take the right dose of warfarin because too much can increase the risk of bleeding and~     too little can increase the risk of blood clots. This is why patients are closely monitored~     especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have~     to consider different factors such as patient's age, body size, diet, and other medications~     that can interact with warfarin.~      Certain genes have also been found to affect warfarin dose. Individuals have variations in~     these genes, which can help explain why some patients need higher dose and others require~     less. These factors have been used to better predict a patient's warfarin dose requirement.~     However, these predictions were created based on Caucasian populations and they may not be~     accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims~     to identify new genetic variation that affects warfarin dosing in Hispanic and Latino~     populations and try to better predict a Hispanic or Latino patient's warfarin dose~     requirement.~   "
6482|NCT02972372|"~     The aim of this study is to compare outcomes in Chinese patients with locally advanced~     resectable esophageal squamous cell cancer who have received either surgery or definitive~     chemoradiation (CRT) by the randomized, open-label, multicenter trial.~   "
6483|NCT02972359|"~     The aim of this trial is to investigate the safety of intravenous neridronic acid in~     patients with complex regional pain syndrome (CRPS).~      The trial is divided into 3 periods: a 60-day enrollment period, a treatment period~     consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks~     (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).~   "
6484|NCT02972346|"~     Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary~     nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of~     the main relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve~     serum cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on~     kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children~     steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case~     series of prescription based treatment with ACTH for NS.~   "
6485|NCT02972333|"~     The study aims to investigate the efficacy and safety of AZD9291 in brain metastases from~     patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI.~   "
6486|NCT02972320|"~     This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive~     stage SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the~     first line treatment.~   "
6487|NCT02972307|"~     There has been only minimal research on wheelchair skills by the caregivers of manual or~     powered wheelchair. There are no published data on the extent to which caregivers can~     enhance the mobility of powered wheelchair users. The primary objective of this study is to~     test the hypothesis that caregivers enhance the wheelchair skills capacity, confidence and~     performance of the powered wheelchair users to whom they provide assistance. Our secondary~     objective is to add to the literature on the measurement properties of the wheelchair skills~     test (questionnaire and capability version) for powered wheelchair users and their~     caregivers.~   "
6488|NCT02972294|"~     Fractures of the upper end of the femur, called commonly Hip fractures are very common,~     with an incidence of approximately 1.6 million cases per year worldwide. This high incidence~     is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is~     very frequent on admission for hip fracture, concerning up to 45% of the patients, with a~     mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood~     losses, secondary to the fracture itself and surgery are responsible for a high rate of~     blood transfusion (approximately 40-50% of the patients). However, both anemia and blood~     transfusion are associated with poor outcome, including increased mortality, length of stay,~     infection rate etc. In addition, blood is a scarce and expensive resource and its use should~     be limited as much as possible. There is therefore a need to treat this anemia and/or to~     prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed.~     Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous~     iron was able to reduce blood transfusion (i.e. the number of patients transfused and the~     number of units per patient). Another way to reduce blood transfusion would be to reduce~     perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in~     trauma patients and in elective surgery patients.The interest for perioperative blood~     management has recently increased thanks to better recognition of the adverse effects of~     blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a~     renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose~     a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of~     iron and tranexamic acid to reduce blood transfusion in hip fracture patients.~   "
6524|NCT02971826|"~     The last marketed thrombectomy devices, named stentretriever, permit a better and faster~     recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the~     brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is~     not widely use in Europe and in France. The objective of this study is to assess the~     interest of using this device in the standard care of ischemic stroke in the radiology unit~     of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will~     be collected in order to determine whether or not this device is useful for the practice of~     the radiology unit.~   "
6489|NCT02972281|"~     Antibody deficiencies and complement deficiencies are the most frequent Primary~     immunodeficiencies (PIDs) in adults, and are associated with greatly increased~     susceptibility to recurrent and/or severe bacterial infections - especially upper and lower~     respiratory tract infections and meningitis. The literature data suggest that PIDs are~     under-diagnosed in adults. The current European and US guidelines advocate screening adults~     for PIDs if they present recurrent benign especially upper and lower respiratory tract~     infections, or if they have experienced at least two severe bacterial infections and/or have~     a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest~     of PIDs screening in adult patients who present such recurrent infections and/or after the~     first severe bacterial infection, especially when the patients do not present with known,~     etiologically relevant comorbidities.~   "
6490|NCT02972268|"~     Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination~     Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic~     Hyperplasia~   "
6491|NCT02972255|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study~     that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the~     combination of RO7079901 with meropenem in healthy volunteers. The study will consist of~     three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy~     volunteers will be randomized to receive active study drug or placebo in a 3:1 ratio.~   "
6492|NCT02972242|"~     Coronary computed tomography angiography (CCTA) is a frequently performed test for the~     diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected~     patients. The performance of non-contrast computed tomography for the detection and~     quantification of coronary calcification is typically performed prior to CCTA in an effort~     to identify significant calcification which may influence subsequent data acquisition during~     the CCTA. However, performance of calcium scoring adds significant radiation and most~     coronary calcification is proximal in its location, potentially visualized using a focused~     non-contrast scan.~      The purpose of this study is to prospectively compare the usefulness of a modified~     non-contrast CT, using a significantly shorter scan length and lower radiation parameters,~     as compared to standard coronary artery calcium scanning for the detection of coronary~     calcification that may influence subsequent CCTA performance.~   "
6493|NCT02972229|"~     To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy~     for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic~     spinal tumors~   "
6494|NCT02972216|"~     A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of~     Docetaxel-Based Chemotherapy~   "
6495|NCT02972203|"~     Specific aims for this pilot study are:~      (Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of~     an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a~     60-minute introduction to mindfulness plus referral to community resources on measures~     related to anxiety, depression, and stress, and self-management of chronic illness.~      (Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of~     MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an~     action plan.~      (Patient-Provider Relationship Aim): To examine the effects of level of primary care~     provider mindfulness training on successful referral to program, patient-provider~     relationship measures, and on patient action plan initiation and maintenance.~   "
6496|NCT02972190|"~     Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads~     to potential adverse consequences associated with extensive disruption of posterior bony and~     soft-tissue structures. The investigators plan to compare the clinical and radiographic~     outcomes of bilateral decompression with transforaminal lumbar interbody fusion and~     laminectomy with posterior lumbar interbody fusion in the treatment of degenerative~     spondylolisthesis.~   "
6497|NCT02972177|"~     The objective of the study was to evaluate the efficacy and safety of navigation~     bronchoscopy guided transbronchial ablation for the treatment of early-stage inoperable~     peripheral lung cancer.~   "
6498|NCT02972164|"~     Levels of overweight and obesity have reached alarming proportions in Qatar and other Gulf~     nations. In Qatar, the need to establish national strategies for the prevention and~     treatment of obesity has been recognized in the new Qatar National Health Strategy~     2011-2016, which stresses the need for prevention. In fact, the Qatar National Nutrition and~     Physical Activity Action Plan 2011-2016 calls for nutrition and physical activity~     interventions for the prevention of obesity and related chronic diseases such as diabetes.~     The treatment and prevention of childhood obesity is largely through lifestyle changes-~     encouraging health eating and physical activity and discouraging sedentary behavior.~     However, changing such behaviors is complex and requires a combination of integrated~     approaches to tackle such a multifaceted problem. Herein, the investigators set out to~     implement and evaluate a novel weight management program for Qatari school children at the~     vulnerable age of 9-12 years. The project incorporates a cognitive-behavioral approach that~     involves developing social and emotional competences, promotion healthy dietary habits,~     development of physical literacy, and use of activity monitoring devices to promote~     increased activity while enlisting family involvement in an attempt to maintain weight loss~     in the long term. This project seeks to also take things further by integrating a range of~     interventions that use cutting edge insights from the behavioral sciences through the use of~     MINDSPACE approach (MINDSPACE: Messenger, Incentive, Norms, Default, Salience, Priming,~     Affect, Commitment, Ego) in conjunction with technology tools for monitoring activity and~     providing ongoing support through the use of social media. The intervention involves a~     multi-cohort intervention involving 500 Qatari children over 5 years to be conducted in~     three phases (1) intensive weight loss camps, (2) after-school clubs as~     supplement/consolidation, and (3) maintenance through web and social/family support.~   "
6499|NCT02972151|"~     The trial attempts to optimize, standardize and simplify the characteristic diagnosis and~     treatment program of the dominant diseases in our hospital-the sequelae of pelvic~     inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in~     primary hospital.~   "
6536|NCT02971670|"~     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from~     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of~     the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy~     adults.~      The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant~     Vaccine and to assess persistence of antibodies generated in participants. The second aim of~     the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.~   "
7187|NCT02963155|"~     Prospective research of Natural Killer cells as predictive biomarkers to stratify patients~     likely to have longer response time to castration.~   "
6500|NCT02972138|"~     Sickle cell disease (SCD) is a worldwide distributed hereditary red cell disorder, which~     affects approximately 75,000 individuals in the United States and almost 20,000- 25,000~     subjects in Europe, this latter mainly related to the immigration fluxes from endemic areas~     such as Sub-Saharian Africa to European countries. Studies of global burden disease have~     pointed out the invalidating impact of SCD on patient quality of life. This requires the~     development of new therapeutic options to treat sickle cell related acute and chronic~     complications. SCD is caused by a point mutation in the β-globin gene resulting in the~     synthesis of pathological hemoglobin S (HbS). HbS displays peculiar biochemical~     characteristics, polymerizing when deoxygenated with associated reduction in cell ion and~     water content (cell dehydration), increased red cell density and further acceleration of HbS~     polymerization. Pathophysiological studies have shown that dense, dehydrated red cells play~     a central role in acute and chronic clinical manifestations of SCD, in which intravascular~     sickling in capillaries and small vessels leads to vaso-occlusion and impaired blood flow~     with ischemic/reperfusion injury. In microcirculation, vaso-occlusive events (VOC) result~     from a complex and still partially known scenario, involving the interactions between~     different cell types, including dense red cells, reticulocytes, abnormally activated~     endothelial cells, leukocytes, platelets and plasma factors. Target organs, such as bone or~     lung, are involved in both acute and chronic clinical manifestations of SCD, related to~     their peculiar anatomic organization mainly characterized by sluggish circulation and~     relative local hypoxia. VOCs combined with marrow hyperplasia and inflammation has been~     suggested to contribute to the development of sickle bone disease (SBD). Recently, it has~     been proposed a possible role of vitamin D deficiency in SBD, which appears to be~     subordinated to the primary defect in bone homeostasis. In a humanized mouse model for SCD,~     we recently reported that SBD is due to imbalance between osteoblast/osteoclast activity~     induced by recurrent VOCs. In addition, we show that zoledronic acid prevents bone~     impairment related to SCD, reducing osteoclast activity and improving osteoblast~     performance.~   "
6501|NCT02972125|"~     This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet~     and Dry Syrup in Healthy Male Japanese Subjects~   "
6502|NCT02972112|"~     Women in their 3rd trimester, represent a unique segment of the tokophobic population. In~     these cases help is needed within a very short and limited period of time. To date, no~     specific treatment targets this population in order to ameliorate the anxiety and to provide~     these women and their newborns with better obstetric and psychiatric outcomes. The present~     study investigates an accessible individual two session intervention conducted by midwives~     skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable~     stronger emotional regulation and increase of their capacity to accept unexpected changes~     during labor and feelings of control. The investigators expect this psychological adjustment~     to lead to a better course of delivery, less interventions including caesarian sections, and~     subjective birth experience.~   "
6503|NCT02972099|"~     The objective of the study is to assess the short-term and long-term effects of~     transcutaneous pulsed radio frequency treatment on the physiological status, subjective~     well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is~     a method that is widely used for control of pain. There are no known complications. In this~     study a Radiofrequency generator will be used that has a separate outlet for transcutaneous~     use. Patients will be recruited within the clinic population of patients.~   "
6504|NCT02972086|"~     The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC)~     Model. The IPFAC is intended to increase access to evidence-based behavioral parent training~     (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD)~     who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of~     Developmental and Behavioral Pediatrics.~   "
6505|NCT02972073|"~     The purposes of this study include 1) determine clinical utility of clinical observation of~     aberrant movement patterns during functional trunk and pelvic movements in asymptomatic~     individuals and patients with non-specific low back pain, 2) characterize trunk~     neuromuscular control in asymptomatic individuals and patients with non-specific low back~     pain, and 3) determine the appropriate physical therapy intervention that addresses trunk~     neuromuscular control deficits in patients with non-specific low back pain.~   "
6506|NCT02972060|"~     This is an open label non-comparative controlled randomized phase II study. The experimental~     arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT)~     is included as an internal control.~      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific~     antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline)~     that are in the range of those achieved with 24 weeks of ADT.~      In total, this 1:1 randomized study will therefore require randomization of at least 250~     patients, 125 to each arm.~   "
6507|NCT02972047|"~     This study aims to understand why patients have predominantly upright gastroesophageal~     reflux disease by comparing such patients to healthy persons AND whether a behavioral~     intervention (diaphragmatic breathing) will impact this disease~   "
6508|NCT02972034|"~     This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when~     administered in combination with pembrolizumab (MK-3475). There are two parts in this study:~     Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In~     Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of~     pembrolizumab in participants with advanced malignancies will be identified and confirmed.~     Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in~     combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W)~     for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer~     (CRC) who received at least one and up to five prior lines of therapy will be enrolled at~     the RP2D in the expansion cohort to further evaluate safety and efficacy.~   "
6509|NCT02972021|"~     Chronic respiratory insufficiency in patients with advanced disease to the late treatment~     depends mainly on mechanical ventilation and other high intensity respiratory support~     therapy. Strengthen the stability of chronic respiratory insufficiency intervention can~     reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal~     cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon~     of respiratory support therapy. There is little research on the role of HFNC in oxygen~     therapy for chronic respiratory insufficiency.~      Our previous studies have found the potential value of HFNC in chronic respiratory~     insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of~     chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade~     hospitals in an effort to confirm that HFNC can improve the prognosis of patients with~     chronic respiratory insufficiency compared with nasal oxygen therapy.~   "
7258|NCT02962219|"~     The purpose of this feasibility study is to determine whether a structured exercise~     programme prior to oesophagectomy has: acceptable adherence, is safe, and improves~     physiological measures of physical fitness above standard care.~   "
6510|NCT02972008|"~     Over the past ten years, the number of endovascular procedures has increased by 5% per year~     in Europe with the development of interventional cardiology, such as percutaneous coronary~     angioplasty, aortic valve replacements (TAVR), and vascular endoprosthesis.~      The neurological lesions detected on cerebral MRI caused by these endovascular procedures~     are frequent with an incidence of about 30-70%. These events, although subclinical, have an~     impact on morbidity and mortality and especially on long-term cognitive decline.~      TAVR is the reference treatment for symptomatic elderly patients with stenosis of the aortic~     valve, considered by a multidisciplinary Heart Team as at high surgical risk due to~     comorbidities, age and high perioperative risk scores ( Euroscore 2 and STS scores). Despite~     the net clinical benefit, an increase of silent neurological events was detected on~     post-procedural cerebral MRI with an incidence of approximately 70%.~      The epigenetic involvement in the occurrence of ischemic cerebral lesions is still largely~     unknown. Epigenetic mechanisms, such as DNA methylation, can be associated with aging~     processes and modulate the risk of developing cerebrovascular pathologies. They are likely~     to provide new biomarkers that predict the risk of brain damage.~      Hypomethylation of leukocyte DNA is directly related to atherosclerosis in humans. This~     hypomethylation of DNA would represent an easily measurable marker reflecting the presence~     and progression of atherosclerosis. Because atherosclerotic lesions often precede the~     clinical manifestation of ischemic cardiovascular disease, such as ischemic heart disease~     and stroke, DNA hypomethylation could be used to identify individuals at risk for~     cerebrovascular events.~      The investigator hypothesize that hypomethylation of leukocyte DNA can predict the risk of~     developing new ischemic brain lesions especially after a TAVI procedure.~   "
6511|NCT02971995|"~     Prostate cancer is the first cancer in humans (25%). The most widely used tracer in~     oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the~     other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell~     membranes and has an affinity for prostate cells. Its concentration is directly proportional~     to cell proliferation. The analogue of choline has the advantage of having a rapid and~     stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes~     after injection).~      The goal of this study is to assess the feasibility and the accuracy for targeting image~     guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT~     compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal~     ultrasound (TRUS) .~   "
6512|NCT02971982|"~     Patients will receive RCD or PCD combination as induction treatment followed by rituximab or~     velcade maintenance therapy, as the investigators try to compare the, very good partial~     remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR +~     partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the~     research.~   "
6513|NCT02971969|"~     A long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in~     adult males with moderate/severe to severe hemophilia B.~   "
6514|NCT02971956|"~     This research study is studying a targeted therapy as a possible treatment for advanced~     esophageal cancer.~      The study intervention involved in this study is:~      -Pembrolizumab~   "
6515|NCT02971943|"~     To verify whether X-ray combined with MRI is able to carry out correct fracture~     classification and postoperative evaluation in patients with ankle fractures.~   "
6516|NCT02971930|"~     This study is to generate qualitative data to evaluate the impact of frequency of FVIII~     infusions on patients' satisfaction with treatment and their quality of life.~   "
6517|NCT02971917|"~     To validate the following theory: With TRUVIEW ART™ applied a detector's quantitative~     performance index, MTF(Modulation Transfer Function), is increased 20% or more. This is to~     examine the effect of the increased MTF index, whether it influences or not the~     interpreter's preference~   "
6518|NCT02971904|"~     An observational and prospective study involving about 30 healthy lactating mothers whose~     preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and~     who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until~     15th day of hospitalization or until discharge.~      Considering the lack of evidence related to breast milk nutritional composition from~     Brazilian lactating mothers of preterm infants; and also the utilization of human milk~     analyzer as a tool to optimize nutritional therapy and reach proper growth and development~     of preterm babies, this study aim to evaluate the nutritional composition of human milk from~     lactating mothers of preterm infant during the hospitalization, the infant grow and also the~     applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.~   "
6519|NCT02971891|"~     to evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide~     Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 12 years of age with~     nongenital cutaneous common warts (verruca vulgaris).~   "
6520|NCT02971878|"~     Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and~     a-lipoic acid) on embryo development and subsequently the clinical outcome. Including~     clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse~     system.~      Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of~     study: Study comparing blastocyst development on the same cohort of oocytes using two~     different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an~     absolute increase in Good Quality Blastocysts on day 5 of 7%.~      Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer.~     Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally~     fertilized oocyte.~      Patients: Comparative embryo sibling study with 128 patients included.~   "
6521|NCT02971865|"~     Effects of manual medicine or cognitive behavioral therapy with chronic uncontrolled~     diabetes within a shared primary care visit. An evaluation of the effectiveness of manual~     therapy vs cognitive behavioral therapy (CBT) vs traditional primary care visit care is in~     need.~   "
6522|NCT02971852|"~     Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the~     suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in~     areas of the hand that would be covered by a glove. We investigated the effects of hypnotic~     glove anesthesia on skin temperature measured by thermography.~   "
6523|NCT02971839|"~     This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis~     (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.~   "
6545|NCT02971553|"~     Each year, almost 3 million newborn babies die within their first month of life, often as a~     consequence of labour complications. Approximately 5% of newborns will not start breathing~     at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs~     has not been determined. Animal studies suggest that assisted ventilation with positive end~     expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more~     rapid recovery. However, no large human clinical studies have investigated the clinical~     responses to assisted ventilation with PEEP in asphyxiated newborns.~   "
6525|NCT02971813|"~     While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular~     disease (CVD), participation is generally poor. For this reason, the current research, a~     prospective, randomized controlled pilot study, will evaluate the impact of a social media~     intervention on motivation for exercise and adherence to CR sessions. Participants will be~     randomly assigned to a Facebook™ group or an enhanced education comparison group. The~     intervention will include access to a private Facebook™ group in which participants will~     receive weekly educational posts, weekly provider support and have the opportunity to~     communicate with other cardiac rehabilitation patients. Patients in the comparison group~     will be given the same educational materials, but these will be supplied in handout form, or~     email if the patient is absent from cardiac rehabilitation. Participants will be asked to~     fill out a pre-post motivational questionnaire and the total number of sessions attended at~     the end of 3 months will be tallied. This study is grounded in Self-Determination Theory~     (SDT) and utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is~     based on the SDT.~   "
6526|NCT02971800|"~     The primary objective is to describe the safety and efficacy of intravenous sodium~     fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total~     laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with~     the overall use of sodium fluorescein.~   "
6527|NCT02971787|"~     To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative~     abundance of gut lactobillus species in healthy men~   "
6528|NCT02971774|"~     The aim of the study consists in enriching knowledge of health professionals, on the~     functional difficulties encountered by hemiplegic patients outside the hospital, in~     particular on hobbies, going out with friends or family, work, daily life and the personal~     projects. Another objective is to evaluate the diversity of the attitudes and~     representations of the patients about their body damage. Lastly, the study seeks to develop~     a new grid of evaluation of the quality of life of the patients, which determines more~     fields of the existence significantly impacted by the hemiparesy, from the point of view of~     the patients. It is a question of improving the therapeutic care of the patients and to~     determine if various therapeutic approaches (occupational, pharmacological, surgical) have~     an impact on these various fields. The study will be based on qualitative data (interviews)~     and quantitative (questionnaires).~   "
6529|NCT02971761|"~     This phase II trial studies the side effects and how well pembrolizumab and enobosarm work~     in treating patients with androgen receptor positive triple negative breast cancer that has~     spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth~     of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking~     the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better~     in treating patients with androgen receptor positive triple negative breast cancer.~   "
6530|NCT02971748|"~     The goal of this clinical research study is to learn if pembrolizumab in combination with~     standard hormone therapy can help to control and prevent IBC. The safety of this drug~     combination will also be studied.~   "
6531|NCT02971735|"~     New designs of 6-year undergraduate medical education (UME) in Taiwan mainly include (1)~     integral curricula of body organ system, (2) multiple methods of clinical teaching and~     assessment, and (3) generalism in UME. Accompany with decreasing educational hours in the~     classrooms and hospital, essential but minor components of primary healthcare such as~     ophthalmology and otolaryngology-head and neck surgery (ORL-HNS) is disproportionately~     under-represented in UME. Novel medical education stresses on enabling self-directory~     learning and increasing learning hours outside the classrooms. Accordingly, we hypothesize~     that innovations in educational technology can enhance the learning outcomes of ORL-HNS.~     This study is aimed to determine whether mobile technology in e-learning (M-TEL) is an~     effective tool for the instruction of ORL-HNS and to compare effects of different cognitive~     styles on learning outcomes of M-TEL with various modules of medical education. This is a~     randomized controlled trial. We will recruit 60 UME students without previous training in~     ORL-HNS to undergo the Group Embedded Figures Test to determine their cognitive styles such~     as field dependence or field-independence. After blinded randomization, students are~     instructed on two modules of emergent ORL-HNS disorders, using either a standard e-learning~     of text-figure Power Point show or an interactive multimedia module. Subjects are evaluated~     on emergent ORL-HNS disorders using text-based assessment and multimedia assessment take~     place prior to and following instruction. After 7 days later, they will be assessed using~     global satisfaction score and AttrakDiff2 questionnaire. We anticipate that this study can~     confirm M-TEL can enhance the efficiency of the instruction of ORL-HNS and understand~     differences in learning outcomes of M-TEL with various modules of medical education between~     field dependence and filed independence using this platform.~   "
6532|NCT02971722|"~     JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with~     Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09~     exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose~     covering and islet cell recovering,as well as good tolerance and safety.JY09 has been~     approved by China food and drug administration(CFDA) to enter the clinical research~     stage(Grant number 2016L04254).This study is designed to assess the~     safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09~     in healthy Chinese volunteers.~   "
6533|NCT02971709|"~     Use of shade when outdoors is recommended by health authorities worldwide to reduce overall~     exposure to ultraviolet radiation. However, expensive physical environment changes are often~     required to provide shade and may be effective only when health education has created a~     social environment that motivate shade use. A multi-national research team will explore the~     use of built shade in passive recreation areas within public parks and compare use of built~     shade between the United States and Australia. The specific aims of the project are to: a)~     introduce built shade structures (i.e., shade sails) in public parks in Denver and~     Melbourne; b) compare the use of passive recreation areas with and without built shade; c)~     compare the change in use of the passive recreation areas in Denver and Melbourne after~     introduction of built shade, and d) examine the relationship among social environment and~     physical features of the environment and built shade.~   "
6534|NCT02971696|"~     The aim of the study is to evaluate the efficacy of sorafenib, compared to the best~     supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular~     carcinoma (HCC) based on etiology of hepatitis C virus.~   "
6535|NCT02971683|"~     Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With~     Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults~     With Active Idiopathic Inflammatory Myopathy~   "
7410|NCT02960269|"~     This pilot study will evaluate the impact and overall experience of an interprofessional~     chronic low back pain patient care approach for people in rural and remote areas using~     Telehealth technology compared to secure laptop based videoconferencing (Vidyo).~   "
6537|NCT02971657|"~     This was a prospective study performed between November 2011 and September 2013. Patients~     with a confirmed S. aureus infection after fracture fixation or prosthetic joint infection~     were included. Exclusion criteria included infections involving external fixation pins,~     infections without any implanted hardware and culture positive patients not displaying any~     clinical sign of infection. The following surgical parameters were documented: affected bone~     or joint; type of implant; time between implantation of the device and onset of symptoms.~     Personal characteristics and patients`health status were also documented. Any revision~     surgeries involving the site of interest and all isolated pathogens were recorded throughout~     the course of treatment and follow-up.~      A follow up examination was performed an average of 23 months after discharge. Primary~     outcome at follow up was cure. Cure was defined by the authors as: missing local (at site of~     interest) or systemic signs of infection, terminated surgical and systemic therapy and~     restoration of joint or limb function.~      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken~     from the interface between implant and affected bone. Identification and antibiotic~     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined~     according to the definitions of the European Committee of Antimicrobial Susceptibility~     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays~     according to protocol of Stepanovic et al.(see references).~   "
6538|NCT02971644|"~     To investigate whether implantation of cobalt alloy pedicle screws is effective in treating~     severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are~     likely to have influenced the curative effects.~   "
6539|NCT02971631|"~     Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer~     are known to have a significantly reduced quality of life. To date, there is very little~     information on the physiological causes of this. The investigators suspect that~     overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by~     the lining of the gut may play a role in the reduced appetite, weight loss and low blood~     sugar symptoms seen in this group. To investigate this, the investigators will study the~     response of 16 patients who have previously had a gastrectomy to a glucose drink, and a~     meal, while receiving an infusion of a specific blocker of GLP-1 or placebo. The~     investigators will examine the levels of sugar and associated hormones in the blood, food~     consumption and food reward behaviour using standard tools.~      Participants will be invited to attend the Clinical Research Facility at Addenbrooke's~     Hospital for a screening visit, and two whole day study visits. The study has been designed~     to assess the role of overproduction of GLP-1 by completely blocking its actions, rather~     than assess the use of the blocking compound as a medication, and is therefore regarded as a~     physiological study, not a clinical trial.~      The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and~     appetite derangement in patients who have had a gastrectomy. This will guide future work on~     the development of novel treatment paradigms for the post-gastrectomy patient group.~   "
6540|NCT02971618|"~     The study will retrospectively collect clinical variables and socio-demographic data from~     medical records of patients with T2DM initiating treatment with dapagliflozin after the~     previous failure/inefficiency of other treatment options (defined as non-achievement of~     target Hb1Ac) and according to the officially approved indication as per instruction for the~     use of medicinal product.~      It is expected that the best available data regarding clinical variables and patient~     socio-demographic profiled will be collected from the patient medical records at up to 40~     major Russian outpatient clinics/centers specialized in the treatment and management of T2DM~     patients.~      There are 2 time points:~        -  Baseline data: baseline data are defined as data available within 3 months prior to the~          first dose of dapagliflozin. In case of presence of multiple data values within~          baseline period the most recent pre-dose value will be selected~        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary~          analysis will be focused on data available at 6 plus/minus 3 months after the~          initiation of dapagliflozin. In case of discontinuation dapagliflozin, data will be~          collected at routine visit within 3-month time frame after the last dose.~   "
6541|NCT02971605|"~     The proposed pilot study will assess whether ingestion of a classic hallucinogen~     (psilocybin) leads to changes in emotion processing and neural circuitry that may predict~     repeated self-administration of this drug and underlie an atypical mechanism of abuse~     liability, which may vitally contribute to our understanding of the potential for abuse and~     the underlying mechanisms supporting abuse of classic hallucinogens.~   "
6542|NCT02971592|"~     This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1~     listed medical device, produced to ISO-13485 standards, that delivers extremely low~     intensity (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF)~     intended to reduce muscular aches and pains particularly of the lower back.~      assessing the reduction of lower back pain. Half of participants will receive the MDcure~     device, while the other half will receive a mock device.~   "
6543|NCT02971579|"~     This is a prospective observational longitudinal study~      Aim of the study is to collect information:~        -  on the organization models of the Endoscopic Units performing ERCP in Italy~        -  on the previous and/or ongoing training of the endoscopists performing ERCP~        -  on the clinical characteristics of patients undergoing ERCP in Italy as well as on the~          outcome~   "
6544|NCT02971566|"~     Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical~     arteries places preterm infants at significant risk for developing gastrointestinal~     complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous~     intestinal perforation. Due to the fear of the aforementioned conditions, the establishment~     of adequate enteral feeds is frequently hampered in this population. Previous postnatal~     Doppler studies have shown that AREDF preterm infants who later developed feeding~     intolerance have a decreased blood flow velocity in the superior mesenteric artery in~     response to the first enteral feed; to date, however, it is not known whether this~     hemodynamic impairment persists over time, or if it is associated with reduced splanchnic~     oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS).~      This observational prospective study aims:~        -  to assess the patterns of abdominal oxygenation and perfusion in response to enteral~          feeds in AREDF preterm infants at different phases of enteral feeding establishment;~        -  to evaluate a possible correlation with the development of gastrointestinal~          complications.~   "
6546|NCT02971540|"~     The aim of this randomized trial is to assess the efficacy of analgesia for lumbar~     discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for~     monitoring pain perception postoperatively.~      Patients received either preemptive local tissue infiltration at surgical site using either~     0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous~     infusion using metamizole and tramadol.~   "
6547|NCT02971527|"~     The purpose of this study is to examine whether ultrasound bone strength device (Model~     Number: Oste-scan 500A) is effective and safe in measuring human calcaneal bone strength~     index, compared with a listed, similar device (Model Number: SONOST3000).~   "
6548|NCT02971514|"~     This randomized controlled crossover trial conducted on 25 dental students. in the~     preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and~     toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were~     instructed the proper techniques of brushing and flossing.The study was performed in two~     treatment sessions and a 48 hour washout period. They passed through the sessions in a~     randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all~     oral hygiene for 24 hour. At the first session , they flossed first followed by brushing~     (floss-brush group) and at the other session they used dental floss after brushing~     (brush-floss group) . At each session, before and after brushing and flossing , Dental~     plaque reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque~     was collected for measuring fluoride. Differences between the two groups were analyzed with~     mixed model test.~   "
6549|NCT02971501|"~     This randomized phase II trial studies how well osimertinib with or without bevacizumab~     works in treating patients with EGFR positive non-small cell lung cancer that has spread to~     the brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the~     ability of tumor cells to grow and spread. Giving osimertinib with or without bevacizumab~     may work better in treating patients with non-small cell lung cancer.~   "
6550|NCT02971488|"~     Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction~     strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care~     setting with services to reduce the risk of reinfection and for management of the common~     social and psychiatric comorbidities in this population. More frequent diagnosis, new~     methods that prevent loss of tracking, and access to antiviral treatment are all strategies~     that must be implemented jointly if the prevalence of HCV infection in our setting is to be~     reduced.~   "
6551|NCT02971475|"~     The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for~     treatment of pain in chronic pancreatitis.~   "
6552|NCT02971462|"~     The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would~     reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of~     atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.~   "
6553|NCT02971449|"~     This study compares the traditional, didactic method of training Ugandan community health~     workers with training using tablets in pneumonia management, a common, life-threatening~     illness in children in rural areas.~   "
6554|NCT02971436|"~     This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)~     device with or without SensAwake; and with different pressure support in OSA participants;~     in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the~     pressure delivery will also be evaluated. The FPH device will be compared to a market~     released product.~   "
6555|NCT02971423|"~     This research project is being conducted to look at the safety, tolerability, and~     pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to~     healthy volunteers intravenously as a single dose, and when given as multiple intravenous~     doses for up to 8 consecutive days.~      As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii~     (a type of bacteria) infections, this project will also look at whether ETX2514 will~     interact with the current treatments for these infections when they are administered at the~     same time.~   "
6556|NCT02971410|"~     This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy~     resistance in patients with multiple myeloma that has come back or does not respond to~     treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
6557|NCT02971397|"~     This pilot clinical trial studies the side effects of cytarabine and daunorubicin~     hydrochloride and to see how well they work in treating patients with newly diagnosed acute~     myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading, and may be~     safer for the heart.~   "
6558|NCT02971384|"~     Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets~     (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory~     tract infections.~   "
6559|NCT02971371|"~     Many studies have demonstrated the usefulness of repetitive task practice by using robotic~     devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR)~     has proved to be a valuable tool to improve neurorehabilitation training. Our pilot~     randomized clinical trial aimed at evaluating the correlation between the modifications of~     brain oscillations during a VR neurorehabilitative training of gait and the motor function~     recovery in patients with chronic stroke.~      Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase~     were randomized into two groups. One group performed 40 sessions of Lokomat with VR~     (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes~     (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at~     the EEG) were measured before and after the robotic intervention.~      The robotic-based rehabilitation combined with VR could be associated with improvements in~     several measurements of lower limb function, gait, and balance in patient with chronic~     hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor~     performance and to develop non-invasive brain-computer interfaces controlling robotic~     devices.~   "
7427|NCT02960048|"~     To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning~     splint in patients with temporomandibular joint anterior disc displacement with reduction.~   "
6560|NCT02971358|"~     Prostate cancer is the most common non-skin cancer diagnosed among men and the second~     leading cause of male cancer deaths in the United States. In 2013, it is estimated that~     29,270 men have died from prostate cancer. Although radiation and surgery are quite~     effective for localized disease, there is no effective cure for men who present with~     metastatic prostate cancer as the 5-year relative survival rate is only 28%.~      Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the~     standard first-line therapy in men with metastatic disease but castration-recurrent prostate~     cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops,~     secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.~      Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches~     must be explored to improve the clinical outcome. In this regard, recently emerging data~     suggest that local tumor control may enhance the effectiveness of subsequent systemic~     therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study~     in which they will prospectively evaluate the safety and feasibility of cytoreductive~     prostatectomy in men with newly diagnosed mPCa.~   "
6561|NCT02971345|"~     It is a prospective and multi-center clinical research in China to compare the efficacy,~     safety and related impact factors between TACE alone and endovascular brachytherapy combined~     with stent placement and TACE for HCC with main portal vein tumor thrombus.~   "
6562|NCT02971332|"~     Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study~     the investigators want to evaluate the long term results of Stapled Transanal Rectal~     Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A~     re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was~     conducted.~   "
6563|NCT02971319|"~     This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared~     to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to~     obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an~     intra-individual comparison.~   "
6564|NCT02971306|"~     Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are~     died within first 6 months after the detection of the clinical syndrome. Therefore, it is~     very essential for proper diagnosis and early treatment. In response to acute or chronic~     liver damage, bone marrow derived stem cells can spontaneously populate liver and~     differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte~     may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is~     highly dependent on varieties of liver injury and therapeutic conditions6. The studies has~     suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing~     with hematopoietic cells, thereby enhancing the liver histology and survival rate.~      G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three~     recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in~     patients with alcoholic hepatitis. In two of this studies there was a survival benefit with~     the use of G-CSF.~      Alcoholism leads to decrease in endogenous antioxidant potential. Alcoholic liver disease~     (ALD) patients show low endogenous antioxidants. Chronic ethanol consumption cause selective~     deficiency in the availability of reduced glutathione (GSH) in mitochondria has been~     reported. This is due to impaired functioning of GSH transporter from cytosol to~     mitochondrial matrix. The effect on glutathione replenishing potential by N-acetyl cysteine~     (NAC) can be used to reduce oxidative stress, which also has excellent safety profile.~     Therefore, NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic~     potential factor. NAC also inhibit apoptosis and pro-inflammatory cytokine production. In a~     study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither~     survival benefits nor early biological improvement in severe alcoholic hepatitis patients~     with adequate nutritional support.However, these results must be viewed with caution, since~     the study suffered from a lack of power. In a recent study, NAC and corticosteroids~     combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month~     survival, although the final outcome at 6 month survival was not improved. There are no~     studies on the use of combination therapy of NAC plus G-CSF in patient with severe alcoholic~     hepatitis.~      Therefore we plan to study the safety and efficacy of combination therapy of G-CSF and NAC~     in the patients with alcoholic hepatitis.~   "
6565|NCT02971293|"~     This is a study to evaluate the effects of AZD8871 in patients with COPD. Adult male or~     female patients with moderate to severe COPD, who agree to be in this study, will receive 3~     treatments, i.e. 2 different doses of AZD8871 and placebo (dummy medication containing no~     drug) at once a day for 2 weeks, in a random order. To make the comparison between AZD8871~     and placebo as fair as possible, this study is double blinded. This means that neither~     patient nor the study doctor will know in which order the 3 treatments will be given. This~     study will include patients who are between 40 and 80 years of age. In total there will be~     42 patients participating in this study at two study centers in the United Kingdom and~     Germany. The study will have a total of 12 visits for each patient spanning for a period of~     4 to 6 months. The study is anticipated to run for approximately 8 months and should not~     exceed 10 months.~   "
6566|NCT02971280|"~     Exposure to heavy metals may interfere with basic cellular functions, including DNA~     synthesis.~      The aim of the study is to correlate heavy metals concentration in body fluids of~     reproductive importance and IVF outcome.~   "
6567|NCT02971267|"~     Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated~     inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized~     protocols will be used for the assessment of medical history and examinations, laboratory~     biomarkers, and the collection of various biomaterials for biobanking purposes.~   "
6568|NCT02971254|"~     Recovery of the cognitive functions and recovery features after general anaesthesia in Down~     syndrome patients. A comparison of Sevoflurane and Desflurane.~   "
6582|NCT02971072|"~     The purpose of this study is to examine deficits in activation and motor patterns, as well~     as central drive in patients with rotator cuff tendinopathy. There are three specific aims:~     (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients~     with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle~     activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle~     activation between patients with rotator cuff tendinopathy and healthy controls.~   "
6583|NCT02971059|"~     Currently there are insufficient published studies on amino acid requirements in the~     elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine~     has been observed in in the blood of older adults. It is due the increased uptake by the~     liver and intestine. This decreased levels of phenylalanine could lead to decreased skeletal~     muscle protein synthesis. Requirement for elderly individuals have been set based on studies~     conducted in younger adults hence may be inaccurate. The goal of this study is to directly~     measure the phenylalanine requirement of male and female elderly subjects over 65 years~     using the direct amino acid oxidation (DAAO) technique.~   "
7623|NCT02957435|"~     The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of~     eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of~     50mg) in male and female healthy subjects under fasting condition.~   "
6569|NCT02971241|"~     The primary purpose of the study is to understand the potential of mobile computing~     technology to improve chronic disease self-management, quality of life, and health outcomes~     of older adults to prevent or alleviate future disabilities. Thus, the study will design,~     develop, and test an intervention to motivate and train seniors to use the technology, and~     conduct a trial to evaluate its effect. This innovative intervention will deploy young~     generation (age 18 to 30) volunteers to provide mobile technology training, access, and~     support to older adults (aged 55 and above) with type 2 diabetes in Taiwan. Hence, a~     secondary purpose of the study is to understand the effects of the volunteering experience~     on the values, characters, and health awareness in the young generation. This program,~     called the Intergenerational Mobile Technology Opportunities Program (IMTOP), will help~     older adults with type 2 diabetes acquire skills to use the Internet, World Wide Web (WWW),~     applications (or apps), and basic computing via mobile tablet devices. These skills will~     give participants access to resources and tools to improve health and mental health, reduce~     social isolation, and increase social engagement, as well as meet their individual life~     goals. The course will use young volunteers to deliver the tablet training. The training~     course will be offered as small-group sessions over an 8-week period (for up to 16 hours of~     training) at a hospital site, plus young volunteers' technical support and problem solving~     for up to 4 weeks after the training sessions are completed. Using college students to serve~     as volunteer trainers for teaching mobile technology, the research also aims to understand~     not only how the intergenerational interactions help the older adults learn the technology~     and improve health, but also how they make impacts on the young adults' skills and~     experiences that will help them in their future careers and in the development of their~     characters. This research study will recruit three hundred fifty (350) patients from the~     collaborating hospitals, including two hundred fifty (250) patients from Taipei Tzu Chi~     Hospital and one hundred (100) patients from Hualien Tzu Chi Hospital. An estimate of 140~     students in colleges and universities in Taiwan (100 volunteers in Taipei hospital and 40~     volunteers in Hualien hospital) between the age of 18 and 30 will be recruited to serve as~     volunteer instructors to teach older adults to use tablets and to provide technical support~     services. Moreover, another group of 140 young adults, also age 18 to 30, will be recruited~     from universities to serve as the comparison group to the volunteers in intervention group.~     The course objectives are to guide older patients with Type 2 diabetes to use technology to~     obtain diabetes-related medical information, learn to record and control their physiological~     data via technology, promote intergenerational communication, enhance the convenience in~     life, and improve social life and mental health through technology tools such as the~     Internet, social media, online health education resources, instructional videos and so on.~     It is hoped to further slow down degradation, promote health and prolong life.~   "
6570|NCT02971228|"~     The purpose of this study is to determine whether the Bionic Pancreas with ZP4207~     (dasiglucagon*) is feasible to improve glycemic control in adults with type 1 diabetes~     mellitus.~      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207~   "
6571|NCT02971215|"~     The purpose of this study is to assess the effectiveness of high intensity laser therapy in~     the treatment of subacromial impingement syndrome.~   "
6572|NCT02971202|"~     The purpose of this study is to determine the key factors influencing insulin sensitivity in~     type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).~      Our study tests the hypothesis that decreased insulin sensitivity is primarily driven by~     chronically elevated insulin levels in the blood rather than chronic elevations in blood~     sugar.~   "
6573|NCT02971189|"~     A prospective, single-arm, non-randomised study to evaluate the Librata device performance~     and acute safety in performing global endometrial ablation in pre-menopausal women with~     heavy menstrual bleeding.~   "
6574|NCT02971176|"~     The purpose of this study is to compare the diagnostic accuracy and complication rate~     between low-dose computed tomography-guided and standard-dose computed tomography-guided~     lung biopsy.~   "
6575|NCT02971163|"~     Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED)~     complaint responsible for over 1 million ED visits yearly. Potential causes include benign~     conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of~     serious cardiac conditions. In older patients without a clear cause of syncope hospital~     admission is frequently initiated at very low risk thresholds, though there is little~     evidence that these admissions improve patient outcomes. These decisions are often made~     without significant patient input or discussion of reasonable alternatives. In this~     situation, a patient's values, preferences, and particular circumstances should be taken~     into account. This mutualistic approach to clinical management is referred to as Shared~     Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between~     providers and patients in clinical scenarios where multiple reasonable management options~     exist. To improve syncope emergency care, the researchers can leverage recent advances in~     risk stratification to engage patients in SDM and deliver superior, patient-centered care.~      This study will provide the groundwork for a larger, randomized controlled trial evaluating~     the effects of the decision aid for management of low-risk syncope.~   "
6576|NCT02971150|"~     The purpose of this pilot study is to obtain information about older Veterans' preferences~     for treatment of depression and insomnia and to pilot test the feasibility and clinical~     effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with~     Treatment Resistant Depression (TRD) and insomnia.~   "
6577|NCT02971137|"~     This purpose of this study is to test the telephone delivery of a cognitive behavioral~     intervention (CBI), for smoking cessation among Veteran smokers with chronic pain.~   "
6578|NCT02971124|"~     To assess cognitive performance by means of the game of Solitaire. In this study, the~     investigators want to define relevant game metrics, when playing Solitaire, that may be~     indicative of cognitive performance.~   "
6579|NCT02971111|"~     The purpose of this study is to analyze occurence of bleeding complications during invasive~     procedures in septic patients with normal tromboelastometry results despite prolonged~     standard coagulation tests results~   "
6580|NCT02971098|"~     The over-65 population is not only increasing at an alarming rate, but because six out of 10~     will be managing more than one chronic condition by 2030, they will make up a much greater~     proportion of hospitalizations than ever before. Hospitalizations for disease, injury,~     and/or surgery in this group are likely to impair physical mobility and, therefore, the~     older adults capacity to be physically active both during hospitalization and beyond. The~     resulting sedentary lifestyle is likely to be accepted as the new normal, ultimately~     increasing the risk of skeletal muscle and metabolic dysfunction (e.g. impaired glucose~     disposal, insulin resistance). These devastating outcomes are neither inevitable nor~     necessary if prevented with an appropriate mechanism-based intervention.~      A novel mechanism that may contribute to physical inactivity-induced insulin resistance is~     accumulation of inflammation and ceramide within skeletal muscle. Of interest, increased~     skeletal muscle inflammation and ceramide has been tied to various metabolic disturbances~     such as diabetes and insulin resistance. However, it is currently unknown if skeletal muscle~     inflammation and ceramide are a key mechanism associated with insulin resistance due to~     physical inactivity in older adults.~   "
6581|NCT02971085|"~     In this study, the investigators aim to establish the prostate cancer active surveillance~     prospective cohort in our institution, and finally investigate the 5 year rates of~     reclassification during active surveillance as the primary endpoint of the current study.~   "
7624|NCT02957422|"~     The purpose of this study is to learn if increased dairy food consumption helps brain health~     in older adults by protecting nerve cells from damage.~   "
6584|NCT02971046|"~     The fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from~     damage, in the erythrocytes of healthy school-aged children in response to graded intakes of~     protein to determine if increasing the protein intake above the current recommended DRI~     produces increases in the GSH synthesis rates in erythrocytes of healthy school-aged~     children. Participants will consume specially formulated diets with varying protein levels.~   "
6585|NCT02971033|"~     To address the need for more affordable hepatitis C virus (HCV) antivirals with high~     barriers to viral resistance and strategies to shorten the current treatment duration, the~     goal is to develop affordable therapeutic regimens to prevent HCV entry/spread and test the~     efficacy of those inhibitors for treating HCV infection. The investigators recently~     discovered that a major cholesterol uptake receptor is required for HCV entry into~     hepatocytes and that there is already an FDA-approved drug that inhibits cholesterol uptake~     by this receptor. Importantly the same drug also potently blocks HCV entry in human liver~     cells both in cell culture and in a small animal model. Further, looking back at people who~     were previously treated for HCV infection, the investigators found treatment response to be~     better (i.e. larger viral log reduction) in patients who happened to be taking ezetimibe~     (EZE). Hence, the objective of this study is to assess whether the FDA-approved drug~     (ezetimibe) is useful for the treatment of chronic HCV. The investigators predict that when~     administered as monotherapy ezetimibe will reduce HCV viremia perhaps allowing for viral~     clearance and that when included in combination treatment regimens that EZE will increase~     HCV decline resulting in faster viral clearance (i.e. shorter/cheaper direct-acting~     antiviral [DAA] therapy). To test these hypotheses, the investigators will execute the~     following aims: (1) Assess the efficacy of EZE monotherapy in chronically HCV infected and~     predict time to cure; (2) Assess the efficacy of EZE as an adjunct therapy in chronically~     HCV infected patients undergoing currently approved HCV DAA treatment.~   "
6586|NCT02971020|"~     The investigators are conducting a pilot study to compare cognitive outcomes among Veterans~     with severe aortic valve stenosis who are scheduled to undergo either aortic valve~     replacement.~   "
6587|NCT02971007|"~     This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy~     of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the~     treatment of moderate to severe VVC.~   "
6588|NCT02970994|"~     This study will evaluate the association of linear growth on neurobehavioural outcome in~     preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.~   "
6589|NCT02970981|"~     The purpose of this study is to assess the safety and tolerability of treatment with~     Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV~     melanoma.~   "
6590|NCT02970968|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in~     the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who~     satisfy the selection criteria for the study, will be randomized to one of two treatment~     groups, active or placebo.~   "
6591|NCT02970955|"~     Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except~     for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body~     radiation therapy (SBRT).~   "
6592|NCT02970942|"~     Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once~     daily versus placebo in subjects with non-alcoholic steatohepatitis~   "
6593|NCT02970929|"~     An extension study of safety and tolerability of SEP-363856 in adult subjects with~     schizophrenia~   "
6594|NCT02970916|"~     The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or~     without ACE polymorphisms in terms of Progression-free survival (PFS).~   "
6595|NCT02970903|"~     The VitalPAD is a unified, portable and intelligent device that integrates information from~     multiple patient monitors, mechanical ventilators, infusion pumps and clinical information~     systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to~     continuously monitor and coordinate care of critically ill patients.~      This study will use a participatory design process to guide the design of an integrated~     mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.~   "
6596|NCT02970890|"~     Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear,~     causes progressive joint deformity and loss of function leading to the indication of total~     hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and~     induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue~     repair by modulating the inflammatory process and promoting pain relief. It can therefore be~     part of the treatment. This study aims to analyze the effect of PMBT on inflammation and~     pain of patients who underwent total hip arthroplasty. The study will consist of eighteen~     patients who underwent hip arthroplasty and they will receive phototherapy in a period from~     8 to 12 hours after surgery, they will divide into two groups (n=9 each) placebo and~     effective phototherapy. The patients will be evaluated before and after phototherapy with 9~     diodes, applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm,~     40.3J total), by visual analogue scale (VAS) and blood collection for analysis of the levels~     of the cytokines TNF-α, IL-6 and IL-8.~   "
6597|NCT02970877|"~     More and more people in Canada and around the world are severely (morbidly) obese, and this~     is associated with a high risk for poor blood sugar control (insulin resistance, IR) and~     diabetes. Weight loss is often very hard to achieve for morbidly obese patients. Bariatric~     surgery is a very effective treatment, but it has some risks and is not available to all~     patients. Therefore, alternative treatments are needed.~      The gut bacteria (intestinal microbiome) might play a role for the development of obesity~     and IR. Several studies in animals have shown that transferring stool from lean mice or~     humans into obese animals could lead to weight loss and improve IR. One human study has~     confirmed this. The investigators are therefore examining, whether transfer of stool from~     healthy lean people into morbidly obese patients with IR will improve blood sugar control,~     weight, and other obesity related parameters. This will be done in a randomized controlled~     trial. Effects on mental health and the bacterial in the mouth related to gum disease will~     also be assessed.~      If successful, fecal transfer could be a new alternative treatment approach for morbidly~     obese patients or those with IR who do not have access to or do not want to undergo~     bariatric surgery.~   "
6598|NCT02970864|"~     Participants with a traumatic sensory nerve injury in the hand will be recruited to the~     study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will~     undergo repair with the Polynerve. Participants will be followed up regularly, observed for~     device-related complications and to assess the return of sensory innervation.~   "
6599|NCT02970851|"~     The purpose of this study is to assess the effect of bosentan on the myocardial metabolism~     and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.~      Hypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress~     and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET~     / CT for an earlier assessment and optimal management of PAH.~   "
6600|NCT02970838|"~     To evaluate a standardized weight-loss program as treatment option for obesity and type 2~     diabetes, changes in body composition and metabolic control are investigated in obese~     patients with diabetes.~   "
6601|NCT02970825|"~     The investigators perform a prospective, randomized, clinical study involving students in~     education with mood disorders and randomized to an intensive exercise program or a control~     relaxation activity.~   "
6602|NCT02970812|"~     This randomized, placebo-controlled, double-blind, controlled study was designed to~     investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist~     circumference (WC) reduction in abdominal obese adults.~      60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received~     EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as~     control group (CG) 5 times a week for 12 weeks.~   "
6603|NCT02970786|"~     The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2~     for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a~     high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer~     can potentially be used in early response assessment to anti-angiogenic treatment.~      This is a first-in-man study to test the radio tracer in cancer patients. Safety,~     biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour~     and 2 hours post injection).~   "
6604|NCT02970773|"~     The primary objective of this study is to investigate the pharmacokinetic and -dynamic~     properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)~     individuals.~      The secondary objective of this study is to determine the steady-state rivaroxaban activity~     in cervical SCI individuals under long-term therapy.~      Primary Objective In-house patients will be informed concerning the study and informed~     consent will be collected.~      During the screening day, in- / exclusion criteria will be assessed and a blood samples will~     be taken for assessing haematology, clinical chemistry and coagulation parameters.~     Furthermore, the evaluation day will be scheduled.~      On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will~     be introduced into a forearm or lower leg of each participant for the collection of blood at~     the specified time points. Skin inspection for subcutaneous bleeding will be performed and~     vital signs will be recorded. A blood sample will be taken for assessing haematology,~     clinical chemistry and coagulation parameters.~      Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer~     Schering Pharma, Berlin, Germany).~      Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after~     and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity~     will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8,~     12, 24 hours after rivaroxaban administration using a factor Xa inhibition test and~     measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT).~      Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed~     30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.~      Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during~     their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be~     assessed, and the patients will be informed concerning the study and informed consent will~     be collected.~      Blood samples will be taken for assessing haematology, clinical chemistry and coagulation~     parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs~     will be performed.~      A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and~     secondary outcome parameters.~   "
6605|NCT02970760|"~     Adenomas are polyps of the colorectum that have the potential to develop into colon cancer.~     However, some adenomas never become malignant tumors, or if so, progression from adenoma~     into cancer takes a long time. As a result, screening colonoscopy programs were established~     in order to detect and resect adenomas at an early stage. After resection, polyps should be~     sent to pathology in order to make a histological diagnosis. Approximately 40-50% of all~     polyps have adenomatous histology whereas others contain benign histology (e.g. hyperplastic~     or inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.~      The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy~     polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps.~     The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be~     inserted into the colon through a small working channel of the endoscope. Information on the~     actual adenoma size is crucial as surveillance recommendations depend on the size of the~     resected polyps. Moreover current guidelines contain the possibilities to disregard~     hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that~     diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their~     benign dignity. However, there is increasing evidence that large human bias effects exist in~     estimating the size of polypoid lesions. For example, it has been shown that endoscopists~     exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In~     consequence the human bias problem might lead to wrong adenoma surveillance decisions.~      There is no doubt that technical devices are needed which can support endoscopists in~     finding the right declaration of polyp sizes. The aim of the current project is to create a~     computer program that is able to automatically measure polyp sizes during colonoscopy.~   "
6606|NCT02970747|"~     The objective of this non-interventional study (NIS) is to evaluate patients' adherence and~     persistence to carfilzomib therapy in combination with lenalidomide and dexamethasone in~     adult patients with multiple myeloma (MM) who have received at least one prior therapy in a~     real-life setting.~   "
6607|NCT02970734|"~     Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is~     diagnosed as a disorder and serious enough to require treatment affects up to 10% of all~     adolescents by the age of 16. The median age of onset is 11 years, making these disorders~     some of the earliest to develop. Anxiety disorders can have serious negative effects on a~     young person's personal relationships, school performance, and family life. These disorders~     may not be discovered by adolescents, parents and health care providers. Even if anxiety~     disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can~     become sick if their anxiety is not treated properly. The investigators will carry out~     research to test Breathe, an Internet-based treatment for adolescents with anxiety problems.~     Adolescents can use this treatment from home via the computer. Breathe will include~     information materials and personalized homework assignments to help anxious adolescents~     learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com~   "
6608|NCT02970721|"~     The objective of the proposed project is to evaluate adverse maternal and fetal outcomes in~     women who are treated and women who are untreated with mood stabilizing medication for~     bipolar disorder during pregnancy, compared to women without bipolar disorder during~     pregnancy.~   "
6609|NCT02970708|"~     To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating~     anisometropic amblyopia.~   "
6622|NCT02970539|"~     This is a nonrandomized, open-label, single group assignment, safety, tolerability and~     pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in~     combination with ramucirumab.~   "
7625|NCT02957409|"~     The purpose of the study is to describe the heart failure with reduced ejection fraction~     (HFrEF) patient population receiving sacubitril/valsartan treatment.~   "
6610|NCT02970695|"~     Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the~     improvement of sleep conditions and quality of life on the elders with insomnia.~      Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on~     the improvement of sleep conditions and quality of life in the elderly with insomnia.~      Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and~     exhibit poor sleep conditions are recruited.~      Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT.~     Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a~     combined approach (LAT plus MAT).~      The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven~     specific auricular points.~      Main outcome measures Sleep conditions and quality of life will be evaluated at baseline;~     end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.~      Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed~     effect modeling will be conducted as appropriate.~      Expected results This study would advance our knowledge the optimum treatment protocol of AT~     in the improvement of the sleep conditions of the elderly population.~   "
6611|NCT02970682|"~     This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in~     combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.~      Patients will be enrolled into one of three study arms (SFX-01 in combination with AI,~     tamoxifen or fulvestrant) based on their current therapy.~   "
6612|NCT02970669|"~     The purpose of this study is to investigate the effects of initiation of~     sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity~     and sleep in subjects with heart failure with reduced ejection fraction.~   "
6613|NCT02970656|"~     This feasibility/pilot study has three purposes. First, the investigators will determine the~     feasibility of collecting saliva to measure stress biomarkers over three days at home in~     youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet~     program for youth with type 1 diabetes to determine whether changes in stress biomarkers~     associate with self-reported perceived stress and HbA1c. Third, the investigators will~     examine the gene-environment interaction of the top 14 targeted candidate genes and~     epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose~     levels over time.~   "
6614|NCT02970643|"~     The purpose of this study is to determine whether Palonosetron and Olanzapine without~     dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.~   "
6615|NCT02970630|"~     It is a prospective, single-arm, open-label, multicentre study with the principal aim to~     estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant~     recipients of ECD (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged~     release tablets in combination with everolimus tablets.~   "
6616|NCT02970617|"~     This clinical trial studies how well ringing a bell on the final day of radiation therapy~     works in improving the memory of distress in cancer patients. Ringing a bell on the final~     day of radiation therapy may improve the memory of how painful the treatment was.~   "
6617|NCT02970604|"~     Heart attacks and strokes are common causes of death worldwide. These events occur in part,~     due to increased activity of platelets, which cause clotting (thrombosis) within heart and~     brain blood vessels.~      Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and~     therefore protect against heart attacks and strokes. However serious bleeding into the gut~     and brain occurs in a number of individuals prescribed aspirin. Currently, there is no~     reliable method for assessing the relative risks of thrombosis versus bleeding in individual~     patients prior to or during aspirin therapy.~      We have recently discovered that individuals with a particular genetic make-up, those with~     genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky)~     platelets. We then found that these same individuals suffered a greater number of~     cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet~     stickiness and protected against heart attacks and strokes in these patients.~      In this project, we aim to confirm and extend the above findings. We hope that testing for~     PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit~     from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but~     not suffer any bleeding complications.~   "
6618|NCT02970591|"~     Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is~     considered to trigger symptoms associated with the clinical picture of IBS, and dietary~     treatment is thus believed to relieve the symptoms of IBS. As the disease is very~     heterogeneous in its manifestation, different treatment options might be indicated depending~     on the predominant symptom. To investigate the response to different dietary treatment~     options, a randomized controlled intervention trial will be carried out in adult patients~     (>18 y) with IBS according to Rome III criteria. The aim of this study is to compare the~     response to two different dietary treatments or optimized medical treatment.~   "
6619|NCT02970578|"~     To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle~     screw placement using Quandrant system, and verify its feasibility of reducing error rate of~     screw placement and postoperative complications.~   "
6620|NCT02970565|"~     The purpose of this current study is to investigate the efficacy of a group model of Family~     Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The~     behavioral, neurobiological and clinical insights gained from this project may eventually~     lead to better treatment of emotional, behavioral and developmental disorders. The~     investigator hypothesizes that the children who are treated with Family Nurture Intervention~     (FNI), which incorporates interactive touch with vocal soothing, and family practice in~     comforting, will show increased emotional connection and mother child co-regulation with~     better results in the outcome measures in the short term and long term.~   "
6621|NCT02970552|"~     More than 1.5 million HIV-infected women become pregnant each year. Approximately half have~     access to antiretroviral therapy (ART), but all are at increased risk of preterm birth~     (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent~     PTB that should be studied in this high-risk population. This pilot study will provide~     critical insight into the feasibility of a phase III trial by determining whether women are~     willing to participate, to adhere to study drug, and to complete follow-up.~   "
38389|NCT02554552|"~     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa~     clinical trial of YY1201 for treatment of osteoarthritis of the knee.~   "
6623|NCT02970526|"~     This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered~     the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These~     neuropathies remain a problem in oncology because currently no prevention strategy has~     proved effective and only duloxetine seems to have a therapeutic benefit in improving~     symptoms. In the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to~     stop the chemotherapy, potentially degrading the oncological prognosis.~      Objective of this study will be to assess, on a large number of patients (n> 500) who~     completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5~     years after the end of chemotherapy. Furthermore, this study should enable an assessment of~     the relationship between the intensity of neuropathy and comorbidities, such as anxiety and~     depression and health related quality of life of patients.~   "
6624|NCT02970513|"~     The purpose of this study is to determine whether the presence of pathogenic Escherichia~     coli in colon is associated with psychiatric disorders.~   "
6625|NCT02970500|"~     Cancer-related cognitive Impairment, (CRCI) commonly referred to as chemo brain or brain~     fog—impact severely on the Quality of Life (QoL) of cancer survivors, It still remains~     underdiagnosed and challenging to treat. One of the treatment options is the use of~     psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its~     efficacy are limited. We will conduct a phase II study with a mixed method design to explore~     the preliminary efficacy of MP to improve cognitive function and Quality of life in breast~     cancer patients after treatment with chemotherapy and/or radiotherapy and determine the~     parameters needed for designing a phase III study. This study will include two phases: Phase~     one: randomized placebo-controlled clinical trial, phase 2 open-label trial.~   "
6626|NCT02970487|"~     The purpose of this study is to determine the refractive outcomes and optimize the clinical~     features of a new intraocular lens intended to treat the senile cataract.~   "
6627|NCT02970474|"~     Some radiation therapy treatment plans require the use of boluses. Boluses are placed~     directly on the skin overlying the area to be treated. The radiation beam interacts with the~     bolus before entering the body and ensures that the correct radiation dose reaches your~     tumor. The purpose of this study is to determine whether the shortcomings of conventional~     bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to~     create 3D models for boluses. The 3D models can then be printed into plastic boluses using a~     3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours~     better and allow for more precise control over radiation dose. In this study, both a~     conventional and 3D printed bolus will be made. The Investigators will then simulate~     treatment with both boluses to determine which bolus will result in more optimal treatment~     for the participant. The superior bolus will be used in the participant's treatment.~   "
6628|NCT02970461|"~     A randomized controlled trial design is used to test the efficacy of gamification elements~     to drive user behavior in a personal health record.~   "
6629|NCT02970448|"~     The investigators of this study want to see if shortening the total treatment time for brain~     tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser~     Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For~     participants, the total time of treatment from surgery to the end of radiation and~     chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the~     total treatment to 7 weeks.~      To shorten the total treatment time, investigators want to see if it is safe to start~     radiation with chemotherapy within 5 days after surgery. Usually patients start their~     radiation with chemotherapy about 21-28 days after the surgery.~      Shortening the total time of treatment may allow investigators to kill the cancer cells more~     effectively.~   "
6630|NCT02970435|"~     The purpose of this research is to look at how educational videos provided by doctors might~     affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs~     surgery care. Patients will be randomized to either: 1) a group that receives educational~     videos in addition to standard-of-care written and verbal instructions or 2) a group that~     receives only standard-of-care written and verbal instructions.~   "
6631|NCT02970422|"~     The purpose of this study is to distribute a questionnaire created for individuals living~     with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,~     and healthcare and COPD-related research priorities. The data collected will be compared~     across diagnosed COPD stages and disease severity to determine the extent to which adults~     with COPD participate in the listed activities and identify their primary research and~     healthcare related priorities. The questionnaire was originally developed based on past~     research then verified by a panel of COPD and participation experts; as well as, individuals~     living with COPD in the form of focus groups. The questionnaire will now be administered to~     200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where~     clinical data for each participant will be available. This phase will help establish the~     reliability of the questionnaire.~   "
6632|NCT02970409|"~     A clinical, prospective. controlled and randomized study with patients with a peripheral~     venous catheter. Patients will be randomized to either receive heparin or saline. The~     investigators will monitored the clinical out come to further evaluate catheter colonization~     rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.~   "
6633|NCT02970396|"~     This is an investigation of adult individuals with epilepsy, and involves educational and~     behavioral interventions intended to enhance treatment adherence and self-management.~      The investigators are adapting a self-management intervention that they developed in a~     previous study to individuals with epilepsy and a history of negative health events (NHEs),~     such as accidents and emergency department (ED) visits, diminished quality of life and poor~     mental well-being. The intervention Self-management for people with epilepsy and a history~     of negative health events (SMART) is intended to reduce NHEs and improve quality of life in~     people with epilepsy associated with historically disadvantaged groups.~   "
6634|NCT02970383|"~     This study evaluates the effect of larger or smaller opioid prescriptions following minor~     surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and~     leftover narcotic.~   "
6696|NCT02969577|"~     The purpose of this study is to learn if lifestyle changes and counseling along with~     standard medical care, compared to standard medical care alone, can prevent heart problems~     and diabetes in men who are receiving ADT for prostate cancer treatment.~   "
6635|NCT02970370|"~     The primary study aim is to depict the demographics, clinical and para clinical features of~     patients attending five tertiary referral multiple sclerosis (MS) centers in Egypt.~      This requires effective and unified pooled registries to extract data from with a~     standardized, sufficient and high quality clinical, magnetic resonance imaging (MRI) data,~     neurophysiological data and body fluids.~      Investigators want to shed light on the challenges that face both physicians and patients in~     the area of diagnosis and treatment~   "
6636|NCT02970357|"~     The needs of children and teens with type 1 diabetes are very specific and different from~     the adults with type 1 diabetes. Many organizations such as the World Health Organization or~     the International Society for Pediatric and Adolescent Diabetes, recommend a patient~     therapeutic education when it comes to children with type 1 diabetes.~      This study aims to evaluate the impact of a therapeutic education program on theoretical~     knowledge of the disease and also on quality of life, on biological and clinical indicators.~   "
6637|NCT02970344|"~     The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST)~     intervention for improving breast cancer survivors' abilities to manage symptoms and adhere~     to recommended diabetes self-management. The telephone-based DCST protocol integrates three~     key strategies to reduce symptoms and improve diabetes self-management: coping skills~     training for managing symptoms, adherence skills training, and healthy lifestyle skills~     training. The investigator will test the effects of the DCST intervention by comparing it to~     diabetes education alone. Physical symptoms, psychological distress, diabetes~     self-management behaviors, and self-efficacy for managing symptoms and diabetes~     self-management will be assessed at baseline and 3, 6, and 12 months. Physical activity~     (i.e., daily steps and distance) will be assessed using wireless activity trackers (Fitbit)~     and data will be obtained from home blood glucose monitoring devices. Fasting insulin,~     fasting glucose, and glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12~     months.~   "
6638|NCT02970331|"~     A multi-center, open-label study that will evaluate the safety/tolerability and~     pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50~     evaluable adolescents 12 to < 17 years of age.~   "
6639|NCT02970318|"~     This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in~     combination with idelalisib or bendamustine in previously treated subjects with chronic~     lymphocytic leukemia (CLL).~   "
6640|NCT02970305|"~     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive~     placebo in the treatment of the negative symptoms of schizophrenia~   "
6641|NCT02970292|"~     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive~     placebo in the treatment of schizophrenia~   "
6642|NCT02970279|"~     Depression is one of the most common mental health disorders and it is estimated up to 50%~     of patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis'~     outcome. However, there is limited research understanding this population, meaning a~     considerable number of people continue to suffer. The purpose of this study is to 1)~     identify depression stasis prevalence and predictors in an existing evidenced-based group~     treatment for depression, 2) run a clinical trial to test whether an embedded intervention~     based on theoretical and clinical practice evidence can help reduce patient depression~     stasis and drop-out rates and 3) understand what aspect of therapy produces change (or~     prevents change in stasis). The study will be based on behavioural activation (BA) therapy~     delivered in an eight-session group format in an Improving Access to Psychological Therapies~     (IAPT) service in the United Kingdom. BA is one of the most effective psychotherapies~     available for depression and focuses on helping patients to increase their engagement with~     valued activities to help break out of the cycle of depression. Firstly, an archived~     anonymised dataset of routine depression measures from patients who have previously received~     the existing group BA treatment will be analysed. Secondly, the group BA treatment delivered~     to patients in 2017 will be enhanced with two treatment augmentations. One augmentation will~     target stasis outcomes through the addition of specific 'if-then' planning (known as~     implementation intentions) when setting between-session homework and the other augmentation~     will target patient drop-out by informing patients about group BA effectiveness and~     therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in~     the trial will be compared with the archived outcomes to see if the intervention has had an~     effect and the role of engaging in valued living as a mechanism of change for depression~     symptoms will be examined. It is hypothesised that a) 50% of patients who have received the~     existing BA group treatment for depression will have a stasis outcome, b) there will be a~     significant reduction in depression stasis outcomes and drop-out rate following the enhanced~     BA group treatment delivered in the trial and c) engagement in valued living will have a~     mediating effect on outcome for responding patients following the enhanced BA group~     treatment but the effect will not be present for patients with a stasis outcome.~   "
6643|NCT02970266|"~     The main objectives of this study are:~        1. Improve genetic counseling by establishment of prevalences of each of genetic subtypes~          within a expanded population of patients with LCA taking into account ethnicity of~          families.~        2. Confirm, refine or modify the genotype-phenotype correlations.~        3. Edit important recommendations for:~             -  The clinical and paraclinical exploration of a new patient based on genotype,~               especially for extraocular explorations, to book at certain genetic subtypes~             -  Prenatal care of a couple.~             -  Directing families to a therapeutic protocol in progress or in development.~        4. Individualize a panel of families without a mutation in the known genes and identify~          new genes responsible.~   "
6644|NCT02970253|"~     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus~     capsular flap retention.~      Prospective study design comparing clinical data in randomized THA patients who either had~     capsular resection or capsular flap retention.~   "
6645|NCT02970240|"~     Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic~     fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary~     exercise test (CPET). The aim of this study is to examine if CPET can distinguish between~     ME/CFS patients and healthy controls.~   "
6646|NCT02970227|"~     cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy)~     recruited at baseline by the SFB-TR19 project. Standardized protocols used for the~     assessment of medical history and examinations, laboratory biomarkers, and the collection of~     various biosamples for biobanking purposes.~   "
6647|NCT02970214|"~     Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in~     CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized~     Medicine). Standardized protocols will be used for the assessment of medical history,~     laboratory biomarkers, and the collection of various biosamples for bio-banking purposes.~     Comparisons with the general background population will be performed.~   "
6745|NCT02968940|"~     The purpose of this study is to test how safe and effective treatment with the combination~     of Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma~     after chemotherapy.~   "
6746|NCT02968927|"~     To examine the safety and preliminary efficacy of multiple adjunctive host directed TB~     therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent~     permanent lung damage.~   "
6648|NCT02970201|"~     Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population~     receiving chronic hemodialysis. The complications associated with missed or shortened~     dialysis sessions are serious and frequently require emergent medical care or~     hospitalization. Previous studies have shown that electronic messages have significantly~     improved attendance rates in a primary care setting, but these messages have not been~     validated in the chronic dialysis population.~      An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs~     (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or~     phone calls to notify patients prior to each upcoming appointment, as well as alert a~     designated patient advocate. Patients receiving the messages are provided with key contact~     information for a dialysis rescheduling phone line, transportation resources, social work~     services, etc. They may also receive instructions on what to do if they are experiencing~     physical symptoms and need educational facts about dialysis. In particular, the intervention~     is designed to demonstrate to patients that the center cares and is concerned for their~     health and wellbeing. This intervention may potentially improve patient adherence to their~     scheduled sessions, increase patient satisfaction with their treatment, and prevent medical~     complications associated with missed dialysis appointments.~      This study aims to determine whether an electronic intervention, which sends SMS text~     messages or phone calls of key dialysis treatment information, is able to improve dialysis~     treatment session attendance among dialysis patients with a history of poor attendance. We~     secondarily aim to identify the factors that may be barriers to dialysis treatment session~     attendance and the emergency department or hospital utilization associated with missed~     dialysis treatments.~      Patients will be prospectively identified, recruited, and randomized into two groups. Group~     A will receive the electronic intervention prior to their appointments; Group B will not~     receive any electronic intervention. After 8 weeks, crossover will occur for both groups and~     the study will continue for an additional 8 weeks. Participants' clinic records will be~     reviewed to determine the numbers of missed and attended appointments, as well as records of~     ED visits and hospital admissions. Subjects will be asked to complete a post-study~     satisfaction questionnaire.~   "
6649|NCT02970188|"~     The purpose of this study is to assess the safety and efficacy of time-restricted feeding~     (eating within an 8-hour window) for improving physiological function (vascular, motor,~     cognitive and metabolic function) in healthy middle-aged and older adults.~   "
6650|NCT02970175|"~     The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on~     the location and the histological type of the lesion, as well as on the number of biopsy~     samples performed. The increasing number of sampling is also important to provide material~     for molecular assessment of lung cancer. The French National Institute for Cancer recommends~     a number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing~     the number of bronchial biopsies comes with a higher risk of bleeding, the management of~     endobronchial bleeding may be determinant for the diagnostic yield.~      The most recent recommendations of the British Thoracic Society for the management of~     bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of~     1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include~     the use of endobronchial terlipressin, which has local vasoconstriction effect. After~     endobronchial administration of terlipressin, plasmatic concentrations are low, and are not~     clinically relevant.~      The hypothesis of this clinical trial is that endobronchial instillation of terlipressin~     before sampling endobronchial tumor will limit the endobronchial bleeding and allow to~     increase the number of biopsies performed and, eventually, the diagnostic yield.~   "
6651|NCT02970162|"~     This study evaluates the effect of withdrawing amifampridine phosphate treatment from~     patients with LEMS. One half of the patients will continue to receive amifampridine~     phosphate and the other half will receive placebo, during this double-blind study.~   "
6652|NCT02970149|"~     Background: Inflammatory bowel disease (IBD) is a group of disorders characterized by~     chronic inflammation of the gastrointestinal tract with remissions and relapses. The two~     most common subtypes are Crohn's disease (CD) and ulcerative colitis (UC). In 2012, the~     burden-of-illness report from the Crohn's and Colitis Canada estimated that the direct~     medical costs of IBD in Canada were over one billion dollars, primarily funded through the~     Canadian public healthcare system.~      Many life style-related factors may play an important role in the pathogenesis of IBD and~     can contribute to trigger disease relapse, but several of these factors are poorly~     understood. These factors may include sleep disturbances. Data on sleep disturbance in~     children with IBD are limited. Sleep deprivation has been shown to cause reactivation of~     colitis in animal studies but similar data are lacking in humans especially in children.~      Hypothesis: In children with IBD, high scores for a sleep disturbance screener will be~     positively associated with IBD relapse Objective: To develop a non-invasive non-costly tool~     to screen for relapses in pediatric IBD patients through examining the association between~     sleep disturbances and disease relapse in children with IBD Methods: This study will~     incorporate an observational prospective design. Participants: Participants will be 90~     children (ages 8-17 years ) under the care of the Pediatric IBD Program at the Children's~     Hospital, Winnipeg. All participants will have an established diagnosis of IBD.~      Measures: Sleep disturbances will be assessed using a sleep diary. Patients will be asked~     complete a daily sleep diary in the week preceding their clinic appointment. The sleep diary~     will provide information about latency to fall asleep, number of awakenings, duration of~     awakenings, total sleep time, sleep quality, and sleep efficiency.~      Mucosal inflammation will be assessed by measuring fecal calprotectin and clinical disease~     activity will be measured Pediatric Crohn's disease activity index (PCDAI) for CD and~     pediatric ulcerative colitis activity index (PUCAI) for UC at clinic visits~     Anxiety/Depression: As anxiety and depression are often comorbid with disturbed sleep,~     levels of symptoms in both domains will be assessed at clinic visit using the Child and~     Parent Report Versions of the Spence Anxiety Scale and the Child Depression Inventory (v.~     2).~      Procedure: Upon obtaining informed consent, each participant will complete 7 days of sleep~     diary recording in the week prior to their clinic appointment. During the clinic visit, the~     PCDAI or PUCAI, Spence Anxiety Scales, Child Depression Inventory will be completed. Fecal~     samples will be collected for fecal calprotectin measurement as a surrogate marker for~     mucosal inflammation. Other investigations will include blood samples for serum hemoglobin,~     serum albumin, and inflammatory markers. Stool samples for infection screen will also be~     collected to exclude any possibility for gastrointestinal infection on top of IBD.A second~     clinic visit will be scheduled 3 months later and the whole process will be repeated in the~     second visit.~      Regression analysis will be performed to examine the association between sleep disturbances~     and disease activity, characteristics and patients' demographics~      Outcomes:~      Primary outcome: Cut-off score of a sleep screener that is associated with disease relapse~     (as diagnosed by fecal calprotectin value of >100 microgram/gram of stools) in children with~     IBD Secondary outcomes: 1. Correlation between sleep disturbance scores and clinical disease~     activity indices (PCDAI and PUCAI). 2. Identification of which sleep component (sleep~     duration, latency, fatigue, subjective quality) is the best at detecting a disease relapse.~      3.Identification of whether sleep disturbance more accurately predicts relapse for CD than~     for UC.~   "
6653|NCT02970136|"~     The purpose of this research study is to determine the best way to increase screening for~     cervical cancer, colorectal cancer, HIV, and Hepatitis C among underscreened Hispanic,~     Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The~     investigator will compare home testing led by a community health worker (CHW) versus clinic~     testing guided by a CHW. Community Health Workers are people who have undergone several~     weeks of community outreach and health education training. During the study period the~     participant will continue to receive all of their regular medical care from their regular~     health care providers. If the participant does not have a health care provider, the~     Community Health Workers would be able to help in referring the participant for care at a~     local health care clinic located in their community.~   "
6654|NCT02970123|"~     Sedentary behavior is engaging in activities in the seated or lying position that barely~     raise the energy expenditure level and has emerged as an important risk factor for obesity,~     diabetes, cardiovascular disease and mortality.~      The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in~     Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by~     increasing casual walking duration and thereby, increase physical activity energy~     expenditure.~   "
6655|NCT02970110|"~     The objective of this study is to acquire human specimens from subjects undergoing routine~     endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.~   "
6656|NCT02970097|"~     The purpose of this study is to compare infraclavicular brachial plexus shot single shot~     block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual~     analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours~     post operatively will be used for comparison.~   "
6657|NCT02970084|"~     Clinical study single center, prospective, randomized, controlled (vs. no supplement),~     open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12~     months will not know the treatment given to the patient, because the diagnostic test in~     question is considered operator-dependent), a parallel group, which aims is evaluate the~     reduction in the level of calcium in the carotid artery and the carotid atherosclerotic~     plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid~     bifurcation with a range of 40-60%.~   "
6658|NCT02970071|"~     The objective of this study is to use of STIC technology to assist the traditional~     echocardiography to dignose the fetal congenital heart disease accurately and then to~     provide a basis for prenatal counseling.~   "
6659|NCT02970058|"~     Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following Cesarean~     Section~   "
6660|NCT02970045|"~     This research trial collects biological samples and clinical information to create a~     repository of data from patients with cancer or a predisposition for cancer. Combining~     genetic information from biological samples and clinical data may lead to more knowledge~     about why certain cancers respond to treatment and help create more personalized medicine.~   "
6747|NCT02968914|"~     An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate~     comparable drug exposure following Subcutaneous benralizumab administration by using~     accessorized pre-filled syringe (APFS) or autoinjector (AI) devices.~   "
6661|NCT02970032|"~     The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500~     units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis~     in patients undergoing microvascular surgery. Additionally, a pilot protocol has been~     developed to titrate these heparin infusions to ensure patients have sufficient VTE~     prophylaxis. All patients will be enrolled in the observational arm of the study and receive~     anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the~     interventional arm of the study and receive real time heparin infusion dose adjustments per~     the pilot protocol. The primary outcome measured will be the percentage of patients with~     anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 500~     units/hour.~   "
6662|NCT02970019|"~     This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's~     disease~   "
6663|NCT02970006|"~     The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg~     illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a~     custom-designed virtual reality leg scenario) will lead to controlled analgesia induction,~     boosting analgesic effects obtained with standard SCS treatments and will further be~     associated with changes in the perception of the affected body part.~   "
6664|NCT02969993|"~     Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of~     operated patients using the voice handicap index scale~   "
6665|NCT02969980|"~     This study is conducted to evaluate the feasibility and efficacy of post-transplantation~     cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic~     hematopoietic cell transplantation (HCT) in patients with myelodysplastic syndrome (MDS).~   "
6666|NCT02969967|"~     The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in~     improving upper extremity recovery for people in the early phases of rehabilitation post~     stroke. The objectives of the study are:~        1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity~          function, strength, movement, spasticity and self-perceived occupational performance,~          in addition to conventional therapy, with continued use immediately after discharge~          from inpatient stroke rehabilitation and while waiting for outpatient occupational~          therapy services~        2. to explore the relationship between the participants' level of self-efficacy and use of~          the SaeboFlex orthosis in the home environment~        3. to explore the participants' experience of use of the SaeboFlex orthosis in the home~          environment.~   "
6667|NCT02969954|"~     Racial and ethnic minorities with type II diabetes in the US are more likely to develop~     complications and die from the disease than the general population. The foreign-born subset~     of this population is less likely to adhere to diabetes care recommendations than US-born~     patients, thereby placing them at higher risk for complications. In our previous pilot~     project, eight stories were assessed through preliminary multi-site intervention for~     acceptability and efficacy in diabetes management among Latino and Somali patients with~     poorly controlled type II diabetes. The goal of this project is to evaluate a new format for~     delivery of a culturally tailored digital storytelling intervention by incorporating a~     facilitated group discussion following the videos, for management of type II diabetes in~     Latino communities.~   "
6668|NCT02969941|"~     To investigate the treatment effect of continuous transcranial magnetic stimulation on~     patients with Parkinson disease, and the underlying neural mechanism by functional MRI~   "
6669|NCT02969928|"~     The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic~     debridement combined with clarithromycin or amoxicillin + metronidazole association for the~     treatment of generalized aggressive periodontitis (GAgP).~   "
6670|NCT02969915|"~     This clinical trial will compare the effectiveness of integrated care centers vs. integrated~     care centers plus HIV patient treatment incentives for achieving HIV treatment targets among~     people who inject drugs and men who have sex with men in India. The investigators will also~     assess cost-effectiveness and barriers and facilitators to implementation through targeted~     mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key~     populations in low to middle-income countries.~   "
6671|NCT02969902|"~     Venipuncture is one of the most common iatrogenic painful and stressful procedures performed~     on children. Interventions aimed at reducing the distress related to this experience are~     widely and strongly recommended. Pain and anxiety management is even more essential because~     it may modify children's memory for procedural pain and the subsequent acceptance of later~     health care painful interventions. Distraction is the most studied psychological technique~     to relieve venipuncture related pain and distress, with a strong evidence supporting its~     efficacy in children and adolescents.~      In recent years several studies showed the effectiveness of a specific tool named Buzzy®~     (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines~     distraction and physical analgesia (vibration and cold) and it was positively tested during~     venipuncture, intravenous cannulation and painful injections in children. Even though its~     efficacy it's well established, most of the published trials did not compare Buzzy with~     other interventions, so that little data are available about its usefulness compared with~     other distractions techniques.~      Hand-held computers are reusable tools, which offer a technological-based active~     distraction. There is evidence supporting their used during painful procedures such as~     venipuncture and a recent published study showed that hand-held computer distraction was as~     effective as nurse-led passive distraction techniques in children.~      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in~     pain relief during venipuncture.~   "
6672|NCT02969889|"~     bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.~     Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.~   "
6673|NCT02969876|"~     The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with~     major depressive disorder.~   "
6674|NCT02969863|"~     To conduct an outpatient study testing two configurations of the bionic pancreas~     (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25~     adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study~     versus usual care with an insulin pump with and without remote monitoring of hypoglycemia.~   "
11169|NCT02910986|"~     This study will examine behavioral and psychological outcomes of breast density notification~     using a 3-group randomized design comparing usual written notification to two educationally~     enhanced approaches.~   "
6675|NCT02969850|"~     Although the African-American (AA) population tends to have lower serum 25(OH)D levels~     compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans~     are harmful. In fact, skeletal health is superior in AA. It is clear that total serum~     25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white~     women and is, therefore, an inappropriate biomarker in this population.~      The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio~     (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The~     investigators propose a six month randomized double blinded study.~   "
6676|NCT02969837|"~     This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple~     Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55~     subjects will be enrolled. Time to progression or death will be calculated from the date of~     first treatment on protocol until the date of disease progression or death from any cause.~     Patients can expect to participate between 12-24 cycles. The primary endpoint will be the~     rate of response by next generation gene sequencing at the end of 8 cycles among~     non-transplant candidates and transplant candidates who agreed to defer transplant.~   "
6677|NCT02969824|"~     This study will investigate the effect of standardized aerobic exercise (AE) compared to~     rest on clinical recovery from sport-related concussion (SRC) within the post-acute phase of~     injury. Participants will be randomized into one of two groups: (1) Aerobic Exercise Group:~     participants will complete a total of eight exercise sessions over the course of 11 days,~     starting at Day 6 post-injury; (2) Usual Care Group: individuals will undergo a period of~     physical rest until symptoms spontaneously resolve. For the purposes of this study, rest~     will be defined as the avoidance of any activities beyond those of daily living, including~     participation in sport and physical activity.~   "
6678|NCT02969811|"~     Blood transfusion is an expensive and finite resource and optimum transfusion threshold in~     surgical patients is yet to be defined. Patients commonly receive blood transfusions to~     reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the~     kidneys), but this treatment may have important adverse effects including postoperative~     infection. Patients undergoing surgery for fractured neck of femur are often elderly, with~     co-morbidities and a high risk of postoperative complications, including MI and AKI. We~     propose to conduct a study with the following aims:~        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for~          fractured neck of femur.~        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac~          and kidney injury in this group.~        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints~          in a future prospective randomised trial of perioperative transfusion.~   "
6679|NCT02969798|"~     HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have~     distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to~     correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to~     optimally prevent the progressive beta cell failure and development of overt type 2~     diabetes.~   "
6680|NCT02969785|"~     The relevance of this study is given by the feasibility to assess the effect of an~     intervention program based on the postural control and trunk neuromuscular activity,~     comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes~     with low back pain. The main outcomes will be computed by electromyography measurement so~     that to assess the trunk neuromuscular activation pattern as well as by force platform~     parameters for determining of postural control. Clinical symptoms such as pain intensity,~     perception of disability and fear and avoidance will also be computed. This is the first~     study to compare two intervention methods using the main biological outcomes related to~     trunk neuromuscular function.~   "
6681|NCT02969772|"~     The aim of the study was to evaluate the tetraplegics movement strategies, assisted by~     Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different~     weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras~     and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the~     triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum~     superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three~     cylindrical objects (different diameters and weights) placed in trunk midline in an~     equivalent distance of the arm's length. The patients were able to reach and made palmar~     grasp in all cylinders using the stimulation sequences assisted by NMES.~   "
6682|NCT02969759|"~     INTRODUCTION: Amyotrophic Lateral Sclerosis (ALS) is a degenerative disease of the motor~     neurones of the brain and the spinal cord. The pathophysiological mechanisms of the disease~     remain unknown. The average age of onset of ALS is about 60 years old, and the mean survival~     of patients is about 2 years. The disease is responsible for a progressive paralysis leading~     to death from respiratory failure. The only treatment available is the Riluzole, with a very~     modest efficiency on the progression of the disease. ALS is the third neurodegenerative~     disease, affecting 6000 persons in France, 150 000 in the world. Among the protagonists~     involved in the occurrence of the disease, mitochondrial perturbations and protein~     accumulations seem to be central elements.~      OBJECTIVES: To precise the implication of energy and protein metabolism in the sporadic~     forms of ALS, to identify potential biomarkers of the disease and to test new therapies.~      METHODS: The investigators will study cell growth, bioenergetics, mitochondrial dynamics,~     free-radicals production, presence of cytoplasmic inclusions, cytoskeleton structure and~     stress response in primary skin fibroblasts obtained from sporadic ALS patients. The study~     will be conducted over a period of three years in 3 centres specialized respectively in~     motor neuron diseases, mitochondrial metabolism and neuronal cytoskeleton.~      PROSPECTS: If the investigators achieve to identify differences between ALS fibroblasts and~     controls, the results will be key elements to reinforce the hypothesis of a systemic disease~     with an important metabolic participation, to better define ALS pathophysiological~     mechanisms, to find potential biomarkers and to test new therapies.~   "
6748|NCT02968901|"~     The purpose of the study is to document the effect of first line dual oral combination~     therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in~     treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).~   "
8569|NCT02945046|"~     This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,~     parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125~     versus placebo in adult patients for the prevention of ECH.~   "
6683|NCT02969746|"~     This is a prospective, multicentric, randomized, open labeled superiority trial~      This study aims to evaluate the efficacy of oral activated charcoal for improving~     elimination of direct oral anticoagulants ( Rivaroxaban, Dabigatran, Apixaban) in case of an~     unscheduled invasive procedure delayed to this anticoagulant treatment.~      The primary outcome is the anticoagulant's half life. Plasma concentration will be measured~     by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic)~     Pharmacodynamics are also determined with specifics anti-Xa levels (Rivaroxaban / Apixaban)~     or dilute thrombin time (Dabigatran).~      A total of 72 patients will randomly be assigned to the charcoal or control group,~     stratified according to their anticoagulant drug.~   "
6684|NCT02969733|"~     Recent clinical studies in abdominal surgery have shown that the use of Xylocaine®~     parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g /~     ml, had an analgesic effect and decreased postoperative morphine consumption.~      This study aims to evaluate the activity of Xylocaine® and ketamine separately administered~     parenterally, in terms of postoperative morphine consumption and decrease incidences of~     postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the~     placebo group.~      The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface~     scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive~     nature of these criteria in the occurrence of chronic pain.~   "
6685|NCT02969720|"~     The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily~     supplemention on diagnosis criteria of metabolic syndrome.~   "
6686|NCT02969707|"~     The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems~     affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial~     magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with~     fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-~     augmentation on the brain networks underlying hypnotizability, as well as the effect of~     rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that~     a combination of these psychological and neuromodulatory treatments will be more effective~     than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the~     efficacy of hypnotic analgesia and hopefully creating a new treatment modality for~     individuals suffering from pain syndromes such as fibromyalgia pain.~   "
6687|NCT02969694|"~     Survey of fifty new psychoactive substances consumers in a context of MTM sexual~     intercourse.~      Evaluation using an hetero-assessment questionnaire about the link between hypersexual~     disorder and the use of synthetic cathinone.~      Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and~     the medico-psycho-social consequences of those practices.~   "
6688|NCT02969681|"~     Preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF~     mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA~     impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that~     high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ, study of~     ascorbic acid (AA) infusions combined with treatment with FOLOX/FORFIRI +/- bevacizumab~     versus treatment with FOLFOX/FORFIRI +/- bevacizumab alone as first-line therapy in patients~     with recurrent or advanced colorectal cancer with mutant RAS.~   "
6689|NCT02969668|"~     The primary objective of study will be to evaluate the effectiveness of interferon-free~     direct acting antivirals (IFN-free DAAs) in the treatment of chronic hepatitis C virus (HCV)~     among patients in opioid-substitution treatment (OST). We hypothesize that rates of~     sustained virological response will be comparable to non-OST populations. Secondary~     objectives include the evaluation of safety data, patients` adherence and patient reported~     outcome measures like functioning (disability), satisfaction with the treatment, health~     status, general health perceptions and health-related quality of life.~   "
6690|NCT02969655|"~     Daprodustat is a drug that is currently being developed as a treatment for renal anemia .~     This study is to evaluate the efficacy and safety of daprodustat following a switch from~     erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are~     currently treated with ESA. The primary objective is to demonstrate non-inferiority of~     daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind,~     active-controlled, parallel-group, multi-center study. The total duration of the study will~     be approximately 58 weeks including screening and follow-up.~   "
6691|NCT02969642|"~     This study evaluates the treatment of migraine pain using low energy laser light to quench~     migraine signals issuing from the sphenopalatine ganglion (SPG).~   "
6692|NCT02969629|"~     The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous~     pain intensity and evoked cold clinical and experimental pain in patients with lumbar~     radicular neuropathic pain (NP). Patients received either apomorphine or placebo in a~     randomized double-blinded manner.~   "
6693|NCT02969616|"~     This prospective, post-market, open label clinical study is designed to measure the~     posterolateral fusion rate at 24 months post operative in subjects who have undergone a~     posterolateral fusion using Trinity Elite with or without local bone.~   "
6694|NCT02969603|"~     The present study is conceived as a pilot study aimed to determine the efficiency of the~     newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid~     scan technique for muscular activity evaluation, creation of anatomic images of muscle~     activity and resolution of metabolic activity distribution within exercising skeletal~     muscle.~   "
6695|NCT02969590|"~     The purpose of this study is to help us determine how hormones impact the production of~     cervical mucus which is a fluid secreted by the opening of the uterus, also called the~     cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones~     that the ovaries make: estrogen and progesterone. Many of the birth control methods women~     use thicken mucus and make it less likely for sperm to enter the uterus. The goal of this~     study is to better understand the effects estrogen and progesterone have on the cervical~     mucus in the body. To do this, the investigators will be using a drug that suppresses~     natural hormone production for 3 months. Estrogen and progesterone will be artificially~     replaced to better understand their effects. The investigators will also be studying the~     effect of a common birth control pill that may work by thickening cervical mucus. Last, the~     investigators will study some of the cells in the cervix that produce mucus.~   "
6697|NCT02969564|"~     The number of metastases in a patient with primary or recurrent prostate cancer has major~     prognostic implication.~      The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR~     with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for~     determining the presence or absence of bone lesions in prostate cancer patient, with up to~     five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold~     standard will be a combination of clinical follow-up, additional imaging and biopsy, as~     indicated by the multidisciplinary discussion at the tumor board. The findings from~     whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will~     be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant~     or probably malignant and compared with the results of follow-up for JAFROC and ROC~     analysis.~   "
6698|NCT02969551|"~     Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of~     sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not~     eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE).~     The frequency and obstructions patterns in different sleep stages are assessed. In addition~     obstruction patterns detected with AG are compared with DISE examination in the selected~     cases.~   "
6699|NCT02969538|"~     The aim of this study is to evaluate the effect of shortening the etching time on the~     18-month clinical performance of resin composite restorations in primary molars after~     partial carious removal. This randomized clinical trial will include subjects (5-10 year-old~     children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will~     consist of 70 primary molars presenting active cavitated carious lesions (with radiographic~     involvement of the outer half of the dentin), located on the occlusal surface. The sample~     will be randomly divided into two groups according to the etching time of the dentin prior~     adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds)~     and half-reduced etching time (7 seconds). The restorations will be clinically followed~     every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival~     estimates for restoration longevity will be evaluated using the Kaplan-Meier method.~   "
6700|NCT02969525|"~     This is a study to evaluate the dose response based on the efficacy, safety and tolerability~     of bimekizumab in subjects with active psoriatic arthritis.~   "
6701|NCT02969512|"~     Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility~     impairment. Given the boom in the older demographic it is not surprising that there is an~     11% increased demand for replacement every 5 years in Canada. Health promotion~     interventions, such as prehabilitation, defined as pre-surgical education, are vital to~     optimizing surgical outcomes, reducing hospitalization costs, accelerating rehabilitation,~     and reducing patient discomfort and pre-operative anxiety. HIPPER is a 2-year randomized~     controlled trial (RCT) that will assess feasibility indicators and clinical outcomes of~     online prehab education modules compared to a traditional in-person education. The~     feasibility indicators (process, resource, management, and treatment issues) and clinical~     outcomes (physical function, anxiety, pain, satisfaction with education, and health related~     quality of life) will be assessed among Vancouver-dwelling older adults aged > 50 years,~     with advanced hip osteoarthritis. The findings will lead to the refinement of the design~     protocol in order to evaluate a contemporary, standardized, and geographically accessible~     prehab education program in a large multi-site RCT.~   "
6702|NCT02969499|"~     This is a prospective, open-label, observational study of the efficacy and safety of ECT for~     BPSD. There is no control or comparison group. Subjects will be compared on outcome measures~     pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30~     subjects over three years~   "
6703|NCT02969486|"~     Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in~     pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is~     fatal in absence of adequate treatment or therapy, as the condition progressively increases~     the workload of the right heart and ultimately leads to its failure. With a minimal~     indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone.~     After initiation of PH therapy, the follow-up of the patient's health status is often~     limited to punctual PAP measurements at the clinic at intervals of several months. The lack~     of more frequent measurements of the patient's PAP strongly hinders the identification of~     short-term trends in pulmonary hemodynamics, and therefore the anticipation of worsening~     conditions or treatment inefficiency. As possible solutions, wireless implantable~     hemodynamic monitors such as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have~     recently been introduced for the continuous monitoring of PAP in patients with PH. The~     benefits of frequent measurements over intermittent clinic visits have been demonstrated in~     several previous studies, notably in terms of prediction of therapy outcomes, anticipation~     of worsening heart failure, feedback rapidity during therapy, or decline in hospitalization~     rates. Nevertheless, despite the undeniable advantages that implantable monitors offer to~     the patient, they remain highly invasive solutions. In contrast, noninvasive alternatives~     for the measurement of PAP exist, such as transthoracic echocardiography, but are~     impractical for frequent PAP assessments due to their dependency on qualified personnel to~     perform the measurement. An optimal PAP monitoring modality for patients with PH should be~     non-invasive (free of any risks or complications associated with cardiac catheterization)~     and unsupervised (able to operate without supervision of a medical doctor). Such a modality~     does not currently exist. In the present study, the investigators propose and investigate~     the potential of a novel non-invasive, continuous and unsupervised PAP monitoring approach~     based on the pulse wave velocity (PWV) principle and the use of electrical impedance~     tomography (EIT).~   "
6704|NCT02969473|"~     In this phase II study, the investigators aim to evaluated the efficacy and toxicity of~     definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)~     versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell~     carcinoma (ESCC).~   "
6705|NCT02969460|"~     The Neurotrack Virtual Cognitive Health Study is a 6-month long, prospective,~     intent-to-treat, study that aims to evaluate the impact of the Neurotrack Virtual Cognitive~     Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle~     behaviors for individuals who show signs of subjective cognitive decline. After the first 6~     months of the study, the study researchers may extend the study and provide participants~     with the opportunity to continue participating in the study for an additional 6 months.~   "
6706|NCT02969447|"~     Prospective randomized trail which compare 2 regimens for third-stage management after~     second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional~     medication after fetal expulsion. Primary outcome was the incidence of placental retention.~   "
7593|NCT02957825|"~     The aim of this study is to test the hypothesis that continuous wireless monitoring on the~     postsurgical ward will improve patient outcome, measured as disability-free survival at~     three months after surgery. Further, the investigators hypothesize that this tight control~     regimen decreases length of hospital stay and treatment costs in patients with~     complications.~   "
6707|NCT02969434|"~     Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue~     pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy,~     improve both sleep quality and also pain management, and reduce interference of pain with~     daily activities. As effective pain relief decreases sleep disturbances, improvement in~     sleep has been proposed as marker of effective pain management. Hence it is useful to~     evaluate sleep disturbances in chronic pain population both in clinical and research~     setting. There are many tools to evaluate sleep quality; the routinely used simple brief~     pain inventory (BPI) has a single question about sleep. We will compare three dedicated~     sleep measures to the BPI in patients with chronic pain.~   "
6708|NCT02969421|"~     Randomized controlled trial that compares methods of tenaculum placement during intrauterine~     device insertion and their effect on pain. The two methods being compared are slow tenaculum~     placement versus tenaculum placement at time of cough. Subjects will be asked to rate their~     pain using visual analog scale. Primary outcome measured is pain at time of tenaculum~     placement. Secondary outcomes are overall pain with intrauterine device insertion and~     provider satisfaction with tenaculum placement.~   "
6709|NCT02969408|"~     This is a 12-week, multicenter, open-label study to evaluate the relationship between ABS~     eMDPI and clinical asthma exacerbation (CAE) in adult patients at least 18 years of age with~     exacerbation-prone asthma. The ABS eMDPI dose will be 90 mcg, 1 to 2 inhalations every 4~     hours as needed, but patient dosing will not be limited to this dosing regimen. The purpose~     of this study is to evaluate the relationship between albuterol dosing and CAE.~   "
6710|NCT02969395|"~     The purpose of this study is to evaluate product performance of Magnetic Resonance (MR)~     Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI~     exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT)~     measurements following 3T MRI scan exposure. This study is required by FDA as a condition of~     approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted~     within Medtronic's post-market surveillance platform, the Product Surveillance Registry~     (PSR).~   "
6711|NCT02969382|"~     A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely~     psychotic adults with schizophrenia~   "
6712|NCT02969369|"~     A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's~     Disease Psychosis~   "
6713|NCT02969356|"~     The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®)~     injections in upper and lower limbs accompanied with a personal exercise plan called Guided~     Self-rehabilitation Contract (GSC) can improve voluntary movements in subjects with~     hemiparesis.~   "
6714|NCT02969343|"~     The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on~     developing health information technology (HIT) tools to engage patients, family, and~     professional care team members in reliable identification, assessment, and reduction of~     patient safety threats in real-time, before they manifest in actual harm.~   "
6715|NCT02969330|"~     The aims of this study are twofold: (1) to develop an innovative approach for studying brain~     glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in~     humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES)~     treatment on brain and brain-stem targets, associated with control of food intake and energy~     expenditure, in response to glucose stimuli, in healthy volunteers.~   "
6716|NCT02969317|"~     The primary objective of this study is to assess the pharmacokinetics of olodaterol~     monotherapy (5 μg) and tiotropium + olodaterol Fixed Dose Combination (FDC) ( 5 μg/ 5 μg)~     delivered by the RESPIMAT inhaler after single dose and at steady state in Chinese patients~     with Chronic Obstructive Pulmonary Disease (COPD).~      The secondary objective is to assess the safety of olodaterol monotherapy (5 μg) and~     tiotropium +olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after 3 weeks once~     daily treatment in Chinese patients with COPD.~   "
6717|NCT02969304|"~     The primary objective of this study is to estimate the proportion of DMF use that is~     prescribed on-label versus off-label. The secondary objectives are: To describe the~     demographic characteristics and medical history of DMF users; To describe prescription drug~     history and concomitant medication use of DMF users; To describe the duration of therapy in~     participants newly initiating DMF treatment; To describe the medical specialties of DMF~     prescribers.~   "
6718|NCT02969291|"~     There is a well-documented association between physical activity & risk for breast cancer~     development and recurrence. It is known that exercise interventions have been effective at~     increasing physical activity levels in breast cancer survivors. Knowing that breast cancer~     survivors are less active than non-cancer patients, a less active lifestyle places them at~     risk of obesity and poor overall health, which in turn also increases risk of cancer and~     cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known~     that hormones and other inflammatory markers play a role.~      This study has three goals:~        1. To investigate the feasibility of a home intervention designed to reduce sedentary~          behavior.~        2. Describe the effects of the intervention on levels of sedentary behavior, physical~          activity, and symptoms.~        3. Assess cost of the intervention.~   "
6719|NCT02969278|"~     The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive~     vulvar cancer (IVC) patients currently not candidate to SNB according to standard~     guidelines.~   "
6720|NCT02969265|"~     The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan~     cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild~     to moderate hypertension who do not reach target blood pressure following 4 weeks of~     treatment with amlodipine monotherapy.~   "
6721|NCT02969252|"~     The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin~     SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male~     and female healthy subjects.~   "
6722|NCT02969239|"~     The purpose of this study is to compare norepinephrine and phenylephrine on the effects of~     maintaining the cardiac output in Cesarean section under spinal anesthesia.~   "
7626|NCT02957396|"~     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic~     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics~     of a novel liquid formulation for the treatment of children in comparison to the adult~     tablet formulation.~   "
6723|NCT02969226|"~     Background: The sickest patients who are admitted to an intensive care unit (ICU) often~     require assistance with their breathing. When patients start to get better, they gradually~     do more of the breathing and the machine does less—this is called weaning. Although~     ventilator use saves lives, the longer it is used, the more complications can occur.~     Clinicians aim to wean patients from ventilators in a timely and safe manner. In most ICUs,~     patients are screened (looked at) once per day to see if they are ready to undergo a weaning~     test (using a variety of techniques) to see if the breathing tube can be removed. Screening~     more than once per day may allow more weaning tests to be conducted. Knowing the best way to~     do a weaning test is important because some methods may better determine who can have the~     breathing tube removed safely. At present, we don't know the best way to help our sickest~     patients to wean from ventilators.~      Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who~     can take breaths on their own.~      Interventions: Patients in our study will receive one type of screening and one type of~     weaning test at random. In the 'once daily' screening groups, clinicians will screen~     patients each morning. In the 'two or more times daily screening' groups, patients will be~     screened in the morning, afternoon, and whenever else clinicians wish to screen. When~     screening criteria are met, patients will undergo one of two weaning tests with low~     ventilator support or no support.~      Outcomes: The main outcome of this study will be the time for patients to be successfully~     removed from the ventilator.~      Relevance: For patients, this study will clarify the best way to remove them from~     ventilators in a timely and safe manner. For clinicians and our health care systems, this~     study holds promise to improve how critically ill patients are weaned from breathing~     machines.~   "
6724|NCT02969213|"~     The purpose of this study is to develop the electronic management platform for children with~     epilepsy, establish large data of Chinese children with epilepsy and explore its biological~     etiology.~   "
6725|NCT02969200|"~     The aim of this study was to investigate renal function decline by measured glomerular~     filtration rate (mGFR) in patients with FD during enzyme replacement therapy, and to explore~     the influence of age on renal function in FD.~   "
6726|NCT02969187|"~     Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain~     management, efforts are continuing to find effective methods to relieve pain after abdominal~     surgery. Although opioid is an effective analgesic it has opioid related adverse events~     (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration~     of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration~     for longer postoperative period analgesic. It provides up to 72 hours analgesia~     postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis~     plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been~     performed to reduce opioid use and control pain in several laparoscopic surgical procedures,~     including colorectal resections, cholecystectomy and bariatric surgery. The aim of this~     study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or~     sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites~     infiltration.~   "
6727|NCT02969174|"~     To establish a genotyping and extraction technology of non invasive prenatal diagnosis for~     fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.~      To achieve prenatal accurate identification of fetal blood group genotypes，and provide~     credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease~     of newborn (HDN).~   "
6728|NCT02969161|"~     This study is to understand how to improve retention in care and treatment services to HIV~     positive pregnant women and their babies in Swaziland. The investigators will evaluate~     outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of~     mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate~     lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to~     understand the outcomes of patients who are LTF from care, and the reasons for disengagement~     from care in the context of PMTCT in order to inform efforts to improve retention in care~     among patients under Option B+.~   "
6729|NCT02969148|"~     To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2~     lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced~     gastric cancer by prospective randomized controlled clinical trial.~   "
6730|NCT02969135|"~     Shoulder disorders are extremely common, with a life-time prevalence in population of 30%.~     About 23% of the working population with shoulder problems are sick-listed. Specifically~     rotator cuff tears are considered some of the principal causes of chronic shoulder pain and~     disability, especially with advancing age. The National Patient Register in Denmark has~     registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35%~     increase.~      A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most~     frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of~     function due to pain and tissue weakness. Little is known about the effects of the~     postoperative training/rehabilitation, and this provides an unclear picture of the total~     treatment procedure of this condition.~      The Danish National Clinical Guidelines from 2013 recommend that these patients are offered~     rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for~     postoperative training is moderate- low. The past few years, there have been conducted 5~     systematic reviews looking at different rehabilitation parameters after rotator cuff~     surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce~     stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon~     healing or clinical outcome. They also conclude that there is a further need to evaluate~     approaches that foster early initiation of rehabilitation and gradual introduction of~     functional load in high-quality, adequately powered trials, also considering key outcomes~     such as return to work.~      Therefore, the aim of this study is to compare the effect of a progressive early passive and~     active movement protocol with a care as usual (limited early passive movement protocol) on~     tendon healing, physical function, pain, and quality of life, in patients operated due to~     traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.~      Shortterm effects of physical function, pain, and quality of life will be studied as primary~     patient reported outcome, while secondary outcomes will be clinical and paraclinical~     outcomes in addition to the longterm effects of physical function, pain, and quality of~     life.~   "
6731|NCT02969122|"~     Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging~     system. Controversy exists on the treatment of this part of patients. This trial aimed to~     explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal~     cytology as the only non-curable factor.~   "
6732|NCT02969109|"~     A study to validate, in a prospective manner, the ability of the predefined Genomic Health~     bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle~     invasive bladder cancer.~   "
6733|NCT02969096|"~     The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation~     therapy for hepatic carcinoma.~   "
6734|NCT02969083|"~     The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC)~     treatments based in real world data in various European countries. The study will allow to~     gain insight in the true proportion of patients that fit to receive complete cisplatin-based~     neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients~     with poor prognostic factors (PS and renal function) who receive only standard treatment~     (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic~     and treatment protocol.~   "
7963|NCT02952976|"~     This study is being done to compare two different Temporary Abdominal Closure methods that~     could be used in cases like yours. The methods being compared are the Barker's vacuum~     packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).~   "
6735|NCT02969070|"~     Hypercholesterolemia is considered one of the most important cardiovascular risk factors.~     Cardiovascular prevention include a class I indication to statins in addition to~     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high~     risk'. Along with non-pharmacologic intervention and prevention strategies, newer approaches~     to reduce cholesterol blood levels currently include nutraceuticals, which are compounds~     derived from foods with cholesterol lowering actions. However, it remains unclear if~     nutraceuticals yield additive positive effects other than cholesterol lowering. In~     particular, there is evidence that Berberine has cardiovascular protective effects and that,~     in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet~     activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation.~     Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in~     vitro, which may reduce postprandial glucose peak, thus improving HbA1c concentration.~     Accordingly, we designated a study to evaluate the effects of two commercially available~     nutraceutical combined pills [LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast~     rice 220 mg (at least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at~     least 4 mg of Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing~     Berberis aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200~     mg (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10~     2.0 mg + Astaxanthin 0.5 mg] on lipid and metabolic profile, platelet aggregation,~     endothelial function and coronary flow reserve (CFR). For this purpose patients with~     hypercholesterolemia not requiring statins or statin intolerant at moderate cardiovascular~     risk will be subjected at day 0 and at day 28, after 4 weeks of therapy, to blood sampling~     to evaluate lipid and metabolic profile, peripheral arterial tonometry (EndoPAT), platelet~     aggregation tests with light transmission aggregometry (LTA), nitric oxide (NO) release,~     endothelial nitric oxide synthase (eNOS) phosphorylation on platelets. Only for CFR,~     patients will be further evaluated also after two hours from the administration of the first~     dose of nutraceutical combined pill. Patients will be randomly assigned to receive therapy~     with LopiGLIK™ or with Armolipid Plus®.~   "
6736|NCT02969057|"~     The objective of the present study is to compare the effects of liquid or solid state of~     food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years~     will be recruited from the general public in Singapore. Fingerpricks and cannulation may~     cause minor discomfort and there may be some slight bruising around the site. Fingerpricks~     and cannulation will be done by an experienced research nurse or a trained research officer~     to minimize participant discomfort. If bruising does occur, it should disappear within one~     day and it should not affect participants' regular daily activity. Participants will be~     limited to a maximum of one test per week. In addition, blood collection will be carried out~     in a sterile designated area and thus the risk of infection will be very low. On rare~     occasions, participants may feel unwell during or after the testing session. We have several~     metabolic suites with beds for these individuals to rest on. The research nurse and research~     officers will monitor the individuals' condition and they will be provided with a ride home~     if required. All the study foods will be prepared in a hygienic manner in a purpose-built~     research kitchen maintained to the highest hygiene standards. The research staff has~     undergone basic training in food hygiene procedures. Hence, the risk of infective acute~     gastroenteritis will be minimal. Participants will be provided with some snacks at the end~     of each testing session. They will also be reimbursed to compensate for their time and costs~     associated with travel and parking at the completion of the study. In addition, participants~     will be provided with their blood glucose, blood pressure, and body composition results,~     with a brief interpretation of these at the conclusion of the study.~   "
6737|NCT02969044|"~     This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in~     seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate~     (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF~     biologic).~   "
6738|NCT02969031|"~     The overarching goal of this project is to improve communication between oncologists and~     their patients by ensuring that the patient's voice is heard in the medical encounter. Thus,~     the hope is to improve the experience for patients living with cancer. The investigators~     seek to accomplish this goal by providing oncologists communication skills training that~     includes feedback on their own audio-recorded conversations. The feedback will come from two~     sources: 1) Professional research assistant coders who will identify objective learning~     opportunities based on specific coding criteria and 2) Trained patient reviewers who will~     listen to the recordings and offer their own, subjective feedback at key moments in the~     encounters.~   "
6739|NCT02969018|"~     The purpose of this study is to determine whether PF-06700841 is safe and effective in the~     treatment of chronic plaque psoriasis.~   "
6740|NCT02969005|"~     Localization of small femur lesions for resection can be challenging and may be associated~     with the need for significant fluoroscopic imaging and tissue dissection.~   "
6741|NCT02968992|"~     The purpose of this study is to investigate how apolactoferrin (an iron-depleted form of~     lactoferrin) may improve mobility and memory in older adults with chronic inflammation.~     Lactoferrin, a known anti-inflammatory agent found in milk, has recently been made available~     in a controlled, pharmaceutical grade capsule. As part of this double blinded and randomized~     study, participants will take daily dosages of lactoferrin or its matched placebo. To~     measure the effects of lactoferrin on chronic inflammation and ultimately on improving~     mobility and memory over 6 months, participants will provide blood samples and complete~     physical and cognitive tests. By measuring biomarkers in the blood as well as changes in~     physical and cognitive measures, the investigators will gain an understanding of how~     lactoferrin may improve chronic inflammation in older adults, and an understanding of~     whether improving chronic inflammation will improve cognitive and physical function.~   "
6742|NCT02968979|"~     The purpose of this study is to assess the frequency of cachexia and the management of~     cachexia and associated symptoms in a patient population with non-small cell lung cancer~     (NSCLC).~   "
6743|NCT02968966|"~     Genetic epileptic encephalopathies (EEs) are a group of very rare and severe,~     pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life,~     and an often severe developmental delay. Genetic defects were found in different ion~     channels such as potassium or sodium channels explaining well the pathological neuronal~     hyperexcitability leading to seizures. Further mutations were also found in proteins~     relevant for cell structure, DNA/RNA processing or the synaptic vesicular metabolism.~     Specific and individualized therapies have not been established neither in the clinical~     routine nor in controlled studies. The goal of this monocentric non-blinded non-placebo~     controlled phase IIb study is the evaluation of the effectivity of anticonvulsive drugs~     specifically working on the ion channels defective in some subtypes of EEs in order to~     establish a standard and individualized therapy for these rare diseases based on the~     specific genetic defect.~   "
6744|NCT02968953|"~     This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a~     single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.~   "
6749|NCT02968888|"~     The aim of this study is to investigate the acute anabolic effects of native whey, whey~     protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and~     elderly. The investigators hypothesize that native whey will give a greater stimulation of~     muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80~     will give a stronger stimulus than milk.~   "
6750|NCT02968875|"~     Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common~     forms of dementia in humans and memory disorder is one of the first symptoms that lead to~     diagnosis.~   "
6751|NCT02968862|"~     The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery~     involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated~     post surgical hospital stay of one to three days. These patients will be randomly assigned~     by the BWH Investigational Drug Service to one of three different groups, each consisting of~     33 patients:~      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine~     6.25 mg for a total volume of 10 ml.~        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a~          total volume of 10ml.~        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as~          the control group.~   "
6752|NCT02968849|"~     This study will evaluate the preventive vaccine efficacy, safety, and tolerability of~     ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults~     over 24 months and potentially up to 36 months from enrollment.~   "
6753|NCT02968836|"~     Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality~     in Intensive Care Unit (ICU) patients.~   "
6754|NCT02968823|"~     Our primary aim is to determine whether licorice gargling provides meaningful analgesia~     after oral surgery. Specifically, we propose to test the primary hypothesis that gargling~     with licorice solution reduces pain after oral surgery more than gargling with sugar water.~     Because effective analgesia can reduce pain and/or opioid consumption, we will jointly~     evaluate verbal response pain scores and overall morphine consumption considering licorice~     to be beneficial only if it proves non-inferior on both measures and superior on at least~     one.~   "
6755|NCT02968810|"~     This randomized phase II trial studies how well simvastatin works in preventing liver cancer~     in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
6756|NCT02968797|"~     SafeSed prototype monitors respiratory parameters by tracking chest movements with optical~     and accelerometer markers. The respiratory parameters are compared to respiratory parameters~     measured by a spirometer and a capnograph.~   "
6757|NCT02968784|"~     This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can~     significantly postpone or eliminate the need of patients with organ confined intermediate~     risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or~     Radiation therapy) for their disease.~   "
6758|NCT02968771|"~     The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in~     order to detect differences based on the type of stress (physical or pharmacological with~     adenosine agonists) and result of test (positive or negative for ischemia) and to indentify~     biochemical markers with prognostic value. Clinical data of enrolled patients regarding~     demographics, cardiovascular risk factors, pretest probability and previous cardiovascular~     disease will be recorded. Follow up will be at one, three and five years and will be~     performed by clinical recordings or phone call when necessary. Blood samples of patients~     undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken~     before, immediately after stress and 2h after stress. Serum samples will be analyzed by~     nuclear magnetic resonance in order to know metabolomic profile.~   "
6759|NCT02967718|"~     Coronary heart disease is still the major cause of death in China. Chinese medicine plays~     more and more important role in CHD prevention and treatment. Phlegm and blood stasis are~     its major pathological basis. Based on that, the investigator aims to evaluate the~     evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre,~     cross-section observation combining with longitudinal tracking on-site survey method so as~     to guide the clinical treatment of CHD.~   "
6760|NCT02967705|"~     This cluster randomized waiting-list controlled pilot study will evaluate the effectiveness~     of pain management group activity organized by the OH on pain intensity and associated~     disability, and co-occurrence of mental or sleep problem in patients with chronic pain.~   "
6761|NCT02967692|"~     To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a~     BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic~     BRAF V600 mutant melanoma~   "
6762|NCT02967679|"~     The primary objective of the study is to assess the effect of MD1003 on motor and sensory~     conduction, in patients suffering from demyelinating polyneuropathies.~   "
6763|NCT02967666|"~     PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog~     tracers has the potential to provide an imaging technique targeting subclinical~     granulomatous disease in those with latent tuberculosis (TB), allowing identification of~     individuals who may be at risk of progression to active TB.~   "
6764|NCT02967653|"~     Lithium remains the gold-standard treatment for bipolar disorder, with 30-40% of patients~     with responding preferentially to this medication. Additionally, lithium is commonly used in~     treatment-resistant depression, and other psychiatric disorders (e.g. schizoaffective~     disorder). Lithium is especially valuable considering the great difficulty in achieving and~     maintaining symptomatic remission, the high rates of disability, as well as tremendous~     personal, family, and societal costs associated with bipolar disorder and~     treatment-resistant depression. Despite this, clinicians are increasingly avoiding lithium,~     largely due to fear of irreversible chronic kidney disease (CKD), particularly in North~     America.~      It is well known that lithium exposure, even when dosed safely (<1.0mmol/L in adults 11 and~     <0.8mmol/L in geriatric patients 12,13), can increase the risk of CKD by 3 times, in large~     part through Nephrogenic Diabetes Insipidus (NDI) 14-19. NDI itself has also been associated~     with acute kidney injury 20, and life-threatening hypernatremia, which is an electrolyte~     imbalance characterized by high levels of blood sodium. Aside from hypertension, diabetes~     mellitus, aging, and other nonspecific CKD risk factors.~      NDI is characterized by excessive thirst (polydipsia) due to increased production of dilute~     urine (polyuria). In NDI, lithium is believed to interact with the inositol monophosphate~     and protein kinase C pathways, thereby affecting calcium-related intracellular signaling,~     cyclic AMP (cAMP), inhibition of Glycogen Synthase Kinase-3 Beta (GSK3Beta), activation of~     MAP Kinase and many other pathways.~      NDI occurs commonly in lithium users: 50% of chronic lithium users have urinary~     concentrating difficulties, with 12-19% have decreased urine osmolality (UOsm) <300mOsm/Kg).~      To date, amiloride (5-20mg/day) is the only medication with prior evidence of therapeutic~     effectiveness in NDI from randomized clinical trials. However as a potassium-sparing~     diuretic 31, amiloride can lead to lithium-level elevations, and can thereby theoretically~     increase the risk of lithium-associated CNS and acute renal toxicity.~      There is a need for novel, well-tolerated agents for the treatment of lithium-induced NDI.~      We recently demonstrated that statins, which are well-tolerated and commonly used~     medications, are associated with low lithium-induced NDI risk in the first and only previous~     cross-sectional study examining statins and NDI in humans (n=71) 33. In this study we~     examined current lithium users aged 20-95, who had a mean lithium duration and serum lithium~     level of 10.6 years and 0.62mmol/L, respectively. Patients were assessed for UOsm following~     10-hour water-restriction, a reliable measure of NDI. We found that 0% (0/17) of statin~     users compared to 20.4% (11/54) on non-users had UOsm <300mOsm/Kg following 10-hour~     water-restriction (Fisher's Exact p=0.055). The main statin prescribed in our previous study~     was atorvastatin 10-40mg/day (n=10) 33, which is the most widely used statin for~     cardiovascular disease. Atorvastatin and other statins are well-tolerated and have not been~     found to have adverse effects on mood, cognition, or renal function.~      The mechanism by which statins may treat NDI is not yet known, but two independent mice~     studies have demonstrated the effectiveness of statins in treating genetic forms of NDI. In~     those mice models of genetic NDI, prostaglandin and intracellular cytoskeleton proteins~     pathways were thought to explain statins' activity on NDI.~      In preparation for this project, our co-investigators Drs. Trepiccione and Christensen have~     initiated a pilot study in mice to investigate whether atorvastatin treatment could improve~     the lithium-induced NDI. NDI was induced in 10 mice by feeding mice with a LiCl-enriched~     diet for 15 days. After induction of NDI, a group of mice received intraperitoneal injection~     of atorvastatin (n=5) and a control group received vehicle (n=5) for additional 5 days in~     parallel with continued lithium treatment. Although our small statistical sample do not~     allow us to reach significance, (n=5 per group), the mice receiving atorvastatin showed a~     tendency to reduce polyuria.~      In line with this research, our present research protocol aims at conducting a randomized~     controlled trial investigating a statin, such as atorvastatin, in the treatment of~     lithium-induced NDI.~   "
6765|NCT02967640|"~     The hypothesis of the present study is that in patients with rotator cuff tendinopathy a~     specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate~     receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1~     has been demonstrated to be crucial for pain regulation in various pain disorders, and in~     biopsies from patients with tendinopathy, NMDAR1 was found to be activated.~      To test this hypothesis a specific NMDA receptor antagonist, ketamine, will be injected~     guided by ultrasound into the subacromial space in patients with rotator cuff tendinopathy,~     and subsequently the pain response will be assessed.~   "
6802|NCT02968407|"~     The study group want to investigate whether doctors, who are in the beginning of their~     training to become surgeons, can rate themself and their peers using Objective Structured~     Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic~     open surgical skills. At the end of the course the participants will be examined at at~     videotaped test. The participants will be asked to rate their own video and two videos of~     other trainees' performances. Ratings will be compared to expert ratings.~   "
6766|NCT02967627|"~     Surgical Site Infections (SSIs) and wound complications are common occurrences following~     colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has~     developing evidence for improving wound complication rates in certain populations. However,~     there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We~     propose a study in which patients are randomized into one of two treatment arms: 1)~     incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30~     days for diagnosis of infection or wound complication. We will compare primary outcomes in~     each group using Chi-Squared statistical testing in order to report a Absolute Risk~     Reduction and Number Needed to Treat~   "
6767|NCT02967614|"~     To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy~     male subjects.~   "
6768|NCT02967601|"~     Background Shivering occurs in circa 50 percent of cases during caesarean section under~     spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does~     not endanger the patients' health, the sensations proved to be unpleasant and a subject of a~     number of patients' complains.~      Objectives The main objective of the study is to establish the anxiety factors that~     influence the risk of muscle-shivering and a detailed assessment of the probability of~     existence of the link between increased anxiety levels with the shivering in case of~     patients undergoing the elective caesarean section.~      Moreover, the outcomes of the study could help to further understand the phenomenon, reduce~     its occurence and as a result of that - improve the comfort of the patients in the~     perioperative period, as well as reduce the frequency of pharmacological treatment to halt~     the symptoms of muscle shivering.~      Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory)~     questionaire in the morning preceding the surgery. Results would be interpreted by one of~     the investigators, who obtained a masters degree in psychology. Caesarean section under~     spinal anesthesia would be performed according to standard procedures used in the~     Samodzielny Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK~     CMKP) hospital, with standard non-invasive monitoring (HR, noninvasive blood pressure~     (NIBP), oxygen saturation (SpO2), Temperature). Additionally, the anesthesiologist would~     note the incidence of shivering and its precise timing 1. since the spinal block 2. since~     the child-birth. Moreover, patients would rate anesthesiology team influence on her anxiety~     level during the cesarean section in 5 grade scale - data would be collected by~     psychologist.~      The survey is planned for a one year timespan or until 200 patients have enrolled.~   "
6769|NCT02967588|"~     Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal~     and is associated with poor clinical outcomes. Non-adherence can be considered intentional~     or unintentional. Findings ways to improve adherence is an important area of research with~     widespread clinical implications, however, previous interventions have generally been~     ineffective. The investigators propose an intervention that challenges both intentional and~     unintentional non-adherence in patients hospitalised following ACS.~      Objectives The objective of this study is to determine the feasibility of a hospital-based~     intervention aimed at supporting medication adherence in patients following an ACS.~      Methods Patients admitted to hospital with an ACS will be recruited for this study. The~     study will target both intentional and unintentional non-adherence over two sessions through~     challenging treatment beliefs and formulating specific action plans to encourage habit~     formation. Patients will be asked to provide in-depth feedback around the acceptability of~     the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will~     not be collected.~      Dissemination If this study seems to be practical to deliver and acceptable to patients then~     it will inform the design of a future randomized-controlled pilot study to test the~     effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e.~     medication adherence).~   "
6770|NCT02967575|"~     This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic~     outcome information on patients suffering from intractable symptomatic cervical disc disease~     requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the~     Triadyme-C polycrystalline diamond compact cervical disc replacement.~   "
6771|NCT02967562|"~     This study compares a fifteen second sustained inflation (SI) to five repeated two - three~     second 'inflation breaths' during resuscitation at delivery of infants born prematurely.~   "
6772|NCT02967549|"~     This study aims to assess whether neurally adjusted ventilatory assist or proportional~     assist ventilation is more effective in infants born prematurely with evolving or~     established bronchopulmonary dysplasia~   "
6773|NCT02967536|"~     Our multi-disciplinary research group works closely with people who have obstructive sleep~     apnoea (OSA). This is a life-long illness that causes breathing to stop during sleep, which~     leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the~     throat reopens, usually during arousal from sleep. In some people the repeated arousals from~     sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels~     affect thinking and feeling, and in some cases we think it damages the brain cells involved~     with memory, attention, emotions and decision-making.~      This study will investigate the relationship between the amount of oxygen in the blood and~     the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected~     in patients that suffer from sleep apnoea. The results will show whether the brain damage in~     patients with sleep apnoea can be reversed with treatment. These findings will guide doctors~     in the treatment for sleep apnoea and they will cast light onto the process of memory~     decline with the aim to preserve brain function.~   "
6774|NCT02967523|"~     This project involves the collection and analysis of retrospective and prospective data on~     patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision~     Infusion System was used/will used be to deliver transarterial chemoembolization with~     doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response~     in a real-world setting as well as identify potential areas for future clinical research.~   "
6787|NCT02968602|"~     Craving for cigarettes is an important aspect that leads to challenges with smoking~     cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers~     than persons without schizophrenia, and may experience craving differently as well.~     Minocycline is an antibiotic medication that may impact craving. We will conduct a two-week~     randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the~     effects of minocycline vs. placebo on craving and smoking behaviors in smokers with~     schizophrenia. Participants will take minocycline or matching placebo for two weeks.~     Participants will be assessed on aspects of craving and smoking behavior at baseline and~     after 1 and 2 weeks of minocycline or placebo treatment.~   "
6788|NCT02968589|"~     The purpose of this study is to determine if the @ctivehip tele-rehabilitation system~     improves the functional level and quality of life of hip fracture patients and reduce the~     caregiver burden.~   "
6775|NCT02967510|"~     A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled,~     Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low~     Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008%~     Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with~     Vulvovaginal Atrophy.~      Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that~     occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy~     women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal~     dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the~     lower urinary tract. As these alterations frequently affect the quality of life of~     postmenopausal women, it is important for doctors to detect their presence and offer~     treatment options. Estrogen therapy is the most effective treatment of moderate to severe~     symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is~     avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen~     compared with oral therapy; the local route also minimize systemic adverse effects. The~     search for therapeutic alternatives which may present improvements in relation to the~     current products has been encouraged.~   "
6776|NCT02968745|"~     Aim: To identify the main occupational performance problems reported by individuals with~     rheumatoid arthritis and the relationship between these activities with work status of~     participants . Methods: the investigators conducted a cross-sectional study with 81 patients~     with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data~     was described in frequencies and percentages, and the Pearson's chi-square test was used to~     determine the asymptotic association between the occupational performance problems with~     work.~   "
6777|NCT02968732|"~     A prospective, investigational study to assess the accuracy of standardized cystoscopic~     evaluation with tissue sampling performed immediately prior to definitive radical cystectomy~     to predict pathologic tumor stage and identify patients who may benefit from bladder~     preservation therapy.~   "
6778|NCT02968719|"~     A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate~     the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil~     Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in~     Healthy Adult Subjects~   "
6779|NCT02968706|"~     The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared~     to conventional nasal cannula, improves oxygenation and prevents desaturation events in~     obese patients undergoing colonoscopy.~   "
6780|NCT02968693|"~     Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of~     the lower extremities were included in the retrospective investigation. The patients were~     assigned to the study group of the combination therapy with antibiotic-loaded calcium~     sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA.~     Hematological parameters, eradication of infection, rate of infection recurrence and~     reoperation rate were evaluated during the follow-up.~   "
6781|NCT02968680|"~     This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting~     sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that~     may make it easier to see if the tumor cells have spread to the sentinel lymph node using an~     ultrasound.~   "
6782|NCT02968667|"~     A randomized controlled trial was conducted from November 2015 and May 2016 with 112~     participants of people diagnosed with schizophrenia. Participants aged 18 years or older~     with Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from~     outpatient mental health clinics in Jordan, were randomly assigned participants either to~     receive 6 weeks of a booklet form of intervention with face to face discussion, and~     treatment as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were~     assessed at baseline, immediately post-intervention (post-treatment1) and at three months~     follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes~     for PDwS were psychiatric symptoms, recovery rate and quality of life.~   "
6783|NCT02968654|"~     To compare a liberal and a restrictive strategy to administer blood transfusions in~     critically ill patients with a primary brain injury.~   "
6784|NCT02968641|"~     A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic~     Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with~     Hepatitis Delta Virus~   "
6785|NCT02968628|"~     Alterations in the intrauterine environment can have profound effects on fetal development.~     Diabetes during gestation results in multiple deleterious short-term outcome differences,~     and is correlated with long-term developmental deficits. Multiple studies, in neonates~     through school-aged children, have demonstrated differences in language, attention and~     psychomotor development in offspring of diabetic pregnancies. Neonatal EEG is a promising~     and non-invasive tool for assessment of abnormal brain development or dysmaturity in this~     population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters~     change predictably with advancing gestational development and have been used to~     differentiate between at risk groups in neonatal studies.~      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of~     diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is~     documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of~     aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal~     brain development.~      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to~     gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation~     whose mothers were recommended treatment with either insulin or an oral glycemic agent.~     Video EEG recording will be planned for approximately 60 minutes and obtained between 24~     hours and 5 days of life during birth hospitalization. Additional data will be extracted~     from maternal and neonatal medical records and a maternal questionnaire.~      In addition to evaluating the measures of cEEG and aEEG, this project will establish a~     research cohort. A subsequent study involving developmental evaluations will allow for~     correlation of EEG results with long-term outcomes. The ability to identify those at risk at~     birth would provide the opportunity to intervene in order to mitigate outcome differences,~     particularly in language development. More significantly, we hope to establish neonatal CNS~     outcome measures for future diabetic pregnancy intervention studies. .~   "
6786|NCT02968615|"~     The investigators examined feasibility and acceptability of a non-restrictive diet focused~     on increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled~     in a 12-week assessment which included 6 bi-weekly individual dietary counseling sessions to~     attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of~     individual's ideal body weight).~   "
6801|NCT02968420|"~     The overall aim of this study is to further understand the memory response to HPV~     vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine.~     Although memory responses can be detected shortly after immunization, the best approach to~     measure the long-lasting anamnestic response is to challenge with a booster dose years (> 5)~     after the original exposure.~   "
6789|NCT02968576|"~     Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus~     (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic~     failure. The investigators need better ways to measure adherence in patients on PrEP. This~     application will address the need to measure adherence by evaluating an integrated~     technology system, Proteus Discover, when combined with Truvada. The Proteus Sensor System~     (PSS) will confirm that Truvada was taken, monitor adherence in both recent and long term~     dosing, and provides feedback to encourage adherence. The goal of this study is to determine~     whether the use of the PSS with Truvada will vary the drug concentrations of FTC/TDF.~     Participants will have 2 study visits where they will be randomized to either start with the~     combined PSS with Truvada or just Truvada alone. Study participants will come to the~     Clinical & Translational Research Center (CTRC) in the morning and take the assigned dose~     and will then have blood drawn at about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication~     is taken. Participants will then return to the CTRC for blood draws 24, 48, and 72 hours~     after they took the dose on the first day. The second visit will mimic the first except that~     the participant will take the other dose form.~   "
6790|NCT02968563|"~     The objective of this study is to determine the preliminary efficacy and safety of the~     combination of GS-4059 and idelalisib with and without obinutuzumab in adults with relapsed~     or refractory chronic lymphocytic leukemia (CLL).~      The study has a 6 patient per arm safety run-in to evaluate safety prior to the enrollment~     of subsequent participants. The primary objective is evaluation of efficacy with the~     secondary objective evaluation of safety and evaluation of additional parameters of~     efficacy. The treatment period is adaptive, with a duration of active treatment up to two~     years and a total follow-up on study of 5 years for time-dependent outcome variables.~   "
6791|NCT02968550|"~     . The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar~     distress during one lung ventilation (OLV) at different levels of positive end expiratory~     pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt~     levels during OLV.~   "
6792|NCT02968537|"~     The study aims to investigate the effects of a short computerized training as a therapeutic~     add-on to standard therapy in patients with alcohol-use disorder.~   "
6793|NCT02968524|"~     This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based,~     temperature indicator in estimating the body temperature of Nigerian babies exposed to~     ambient temperature conditions. They will be recruited among babies receiving Filtered~     Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and other~     babies in the nursery at Bowen University Teaching Hospital.~      There will also be an educational session to teach health workers and mothers about the~     signs for hypothermia and hyperthermia on the indicator. Then, we will collect observational~     cross-sectional data on random days to see how many of the trained health workers and~     mothers were able to accurately recognize and provide appropriate response to warning signs~     on the indicator.~   "
6794|NCT02968511|"~     The objectives/specific aims of this study are three-fold. First, the study seeks to~     evaluate the safety of fecal microbiota transplant (FMT) in patients with severe,~     complicated C. difficile infection (scCDI). Second, the study seeks to evaluate whether~     fecal microbiota transplant (FMT) can improve scCDI, with improve defined as either~     decreasing the severity of CDI, or by resolving the infection altogether. Third, the study~     seeks to further study the mechanism by which FMT improves the course of scCDI by performing~     16S rRNA and ITS sequencing on pre-FMT and serial post-FMT stool samples in order to measure~     changes to bacterial and fungal microbiota as a consequence of CDI and FMT therapy. FMT~     material (hereafter referred to as FMTm) would be obtained from OpenBiome. FMTm is prepared~     from prescreened healthy donors.~      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared~     to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.~   "
6795|NCT02968498|"~     Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in~     each study part.~      The objective of the study is to investigate blood glucose levels after oral intake of~     defined amounts of lactulose.~   "
6796|NCT02968485|"~     This aim of study to assess the safety and tolerability of SHR7390 and to define the maximum~     tolerated dose (MTD) of SHR7390 in the patients with advanced solid tumors.~      To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumors.~      To study the effects of food on the pharmacokinetic parameters of SHR7390. To assess the~     antitumor activity of SHR7390 in patients with advanced solid tumors preliminarily and~     recommend reasonable dosage regimen for the follow-up clinical trial.~   "
6797|NCT02968472|"~     A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19~     (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells~     tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change~     process of the CART and residual tumor status of the patient are observe dynamically， which~     summarizes the best therapeutic effect.~   "
6798|NCT02968459|"~     This is a single center, randomized, double blind, placebo controlled study to evaluate the~     safety and efficacy of umbilical cord mesenchyme stem cell local intramuscular injection for~     treatment of caesarean section uterine scars.~   "
6799|NCT02968446|"~     The purpose of this research study is to evaluate the effects of an oral Vitamin D on the~     body's immune system.~      An interest has been growing because studies have shown that Vitamin D may reduce~     inflammation and harmful effects in the body, however, the best dose for Vitamin D is still~     unknown.~      Inflammation is the body's physical response to infection, injury, or long term disease.~     Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the~     body. This study will look at product use, testing skin irritation in healthy volunteers and~     seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could~     one day help doctors prescribe Vitamin D to patients with long term disease to relieve their~     symptoms.~   "
6800|NCT02968433|"~     The purpose of this study is to demonstrate that young plasma infusions can be performed~     safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral~     and laboratory data that will support the next study that will inquire whether young plasma~     infusions improve or slow the progression of cognitive, mood and/or motor impairment and~     rate markers of the disease.~   "
7964|NCT02952963|"~     The purpose of this study is to examine the efffects of bile acid and bile acids~     sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.~   "
6804|NCT02968381|"~     Tobacco use is still the leading cause of preventable disease and death in the United~     States. Tobacco quit lines are effective at helping smokers to quit, but quit lines are~     underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective~     at helping people quit smoking, and is appealing to males and diverse racial groups, but has~     limited reach. The proposed study will develop and test the feasibility and acceptability of~     a guided imagery tobacco cessation intervention that is delivered by a combination of quit~     line coaches and an interactive website. The investigators hypothesize that guided mental~     imagery delivered using the quit line coaching model combined with an interactive website~     could be an effective intervention strategy.~   "
6805|NCT02968368|"~     To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA~     in subjects with CKD~   "
6806|NCT02968355|"~     This study will evaluate the clinical sensitivity and specificity of the FilmArray Global~     Fever (GF) Panel.~   "
6807|NCT02968342|"~     The objective of this study is the role of vaginal progesterone gel in the treatment of~     menopausal hypoactive sexual desire disorder. Half of the study participants will receive a~     standard dose of self applied vaginal progesterone gel and the other half will receive oral~     vitamin tablets.~   "
6808|NCT02968329|"~     Stroke is an important cause of disability and the third leading cause of death.~      Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can~     be found). There have been few previous studies regarding risk stratification for stroke~     recurrence in patients with cryptogenic stroke.~      Recent studies have suggested that left atrial (LA) function is an important determinant of~     stroke risk. However, most studies focus on volume indices and LA dimensions, we also want~     to investigate other echocardiographic parameters. The aim of this study is to assess the~     predictive value of left atrial function for the risk of stroke recurrence and/or atrial~     fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven~     atrial fibrillation (AF) and no indication for anticoagulants.~   "
6809|NCT02968316|"~     This is a prospective observational study correlating Body Impedance Analysis (BIA) with~     pregnancy outcomes.~   "
6810|NCT02968303|"~     Rationale:~      The combination of ipilimumab and nivolumab induces relatively high response rates and~     promising response depth in late stage melanoma. Nevertheless, it takes time till responses~     occur and still a significant number of patients do not benefit from treatment, due to rapid~     progressive disease or resistance to therapy.~      In contrast to immunotherapies targeted therapies (BRAF or MEK inhibitors), can induce~     faster and higher response rates, but often of shorter duration, even when combined.~      Initial attempts of combining vemurafenib or dabrafenib + trametinib with ipilimumab failed~     due to toxicity.~      Patients with elevated levels of serum LDH are less likely to respond to immunotherapy~     compared to patients with normal LDH levels. This does not mean that such patients do not~     benefit at all from immunotherapy.~      This raises the question, whether response rates upon immunotherapy can be improved by~     upfront reduction of tumor burden and normalization of LDH.~      The investigators postulate that induction therapy with combined BRAF+MEK inhibition, and~     subsequent LDH normalization, can improve response rates to the rates seen in LDH normal~     patients.~      To address this question the investigators have setup a randomized phase 2 trial in~     metastatic melanoma patients with elevated serum LDH comparing the response rates upon~     ipilimumab + nivolumab versus ipilimumab + nivolumab preceded by 6 weeks of vemurafenib +~     cobimetinib induction.~      Furthermore, less than half of the patients treated with the combination of ipilimumab and~     nivolumab received maintenance nivolumab, and approximately 40% of all patients discontinued~     treatment for toxicity. In 70% of patients responses were ongoing despite discontinuation of~     treatment due to toxicity. This raises the question, to what extent does maintenance therapy~     add clinical benefit to an ongoing immune response. Preclinical data indicate even that~     continuous restimulation of T cells can result in activation induced non-responsiveness~     (anergy).~      Therefore, a secondary objective of this trial will be, to test a response-driven nivolumab~     scheme~      Objectives:~      Primary Objective • To compare efficacy of induction vemurafenib + cobimetinib followed by~     ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).~      Secondary Objectives~        -  To describe duration of response and overall survival induced by vemurafenib +~          cobimetinib followed by the combination of ipilimumab + nivolumab (Arm A) as compared~          to ipilimumab + nivolumab (Arm B)~        -  To describe the rate and quality of toxicity observed in the two study arms~        -  To describe the rate of ongoing responses upon response-driven flat dose (240mg, q2w)~          nivolumab maintenance~        -  To determine the immune-activating capacity of induction therapy with vemurafenib +~          cobimetinib followed by the combination of ipilimumab + nivolumab.~        -  To evaluate the changes in systemic immune competence~      Study design:~      This is a two-arm phase 2 study consisting of 200 BRAFV600E/K mutation-positive late-stage~     melanoma patients with an elevated baseline LDH level (> ULN, < 3xULN) randomized 1:1~     (stratified according to LDH) to receive either vemurafenib + cobimetinib directly followed~     by ipilimumab + nivolumab (Arm A) or standard first line ipilimumab + nivolumab (Arm B).~     Subsequently, patients in both arms will receive flat dose (240mg, q2w) nivolumab~     maintenance in a response-driven manner.~      Study population:~      Stage IV, or unresectable stage III, BRAFV600E/K mutation positive melanoma patients, naïve~     for BRAF/MEK, PD-1/PD-L1 or CTLA-4 targeting therapy, 18 years and older.~      Intervention:~      Patients will be randomized 1:1 to receive either 6 weeks vemurafenib 960 mg bid +~     cobimetinib 60 mg QD 21-day on, 7-day off (21/7) schedule, directly followed by 4 courses of~     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm A) or first line standard 4 courses of~     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm B).~      Subsequently, patients in both arms will receive nivolumab maintenance flat dose (240mg,~     q2w) in a response-driven manner according to their response at week 18.~      Main study parameters/endpoints:~      Primary Endpoints~      • Compare the best overall response rate (BORR) according to RECIST 1.1 of both arms at week~     18 from start of treatment.~      Secondary Endpoints~        -  Progression-free survival (PFS) according to RECIST 1.1~        -  Overall survival (OS)~        -  Percentage of grade 3/4 toxicities according to CTCv4.03~        -  Percentage of ongoing response, percentage of patients requiring re-induction, response~          percentage upon re-induction~        -  Changes in tumor-specific T cell responses~   "
6811|NCT02968290|"~     The purpose of this study is to quantify the opacity of posterior capsule in pediatric~     cataract comparing two intraocular lens materials.~   "
6812|NCT02968277|"~     The purpose of this project is to evaluate if the LifeWalker Upright walker is improves~     walking and reports of pain compared to a conventional rollator and predicate walker device.~   "
6813|NCT02968264|"~     The aim is to conduct a prospective multi-centre international inception cohort study with~     an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed~     sample size and methodology will result in statistically powerful results to allow for~     evidence-based change to current TOF surgical practices.~   "
6814|NCT02968251|"~     The aim of the study is to design and evaluate a school-based hand washing program for~     children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT),~     so as to improve proper hand washing, increase knowledge level and also reduce school~     absenteeism.~   "
6815|NCT02968238|"~     Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety~     is more common that depression, yet research on the nature and treatment of anxiety has~     lagged far behind that of depression. The investigators' work has demonstrated that CBT is~     superior to enhanced usual care as well as supportive therapy in improving worry, depressive~     symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing~     treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators'~     own work demonstrates that yoga improves sleep. However, no one has conducted a comparative~     effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are~     very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians~     are unable to provide an informed recommendation of one treatment over the other. The~     investigators propose a two-stage randomized preference trial comparing 1)~     cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older~     adults. Participants will be randomized to either the preference group (participants choose~     the treatment) or to the random group (participants are randomized to 1 of the 2~     treatments). This study design allows for the calculation of traditional treatment effects~     (differences in outcomes between participants randomized to either CBT or yoga), selection~     effects (differences in outcomes between participants who choose CBT and those who choose~     yoga), and preference effects (differences in outcomes between participants who choose their~     treatment and those who are randomized to treatment).~   "
6816|NCT02968225|"~     The investigators hypothesize that this serious game (designed to provide a learning~     environment that maximizes opportunities for adolescents with autism to discover the~     functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to~     identify gazed-at objects, and will also lead to increased social attention to faces in~     adolescents with autism. The investigators will test this hypothesis in a small-scale~     exploratory randomized control trial that will include both behavioral and eye tracking~     outcome measures.~   "
6817|NCT02968212|"~     The purpose of this study is to evaluate the clinical effectiveness and safety of~     clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease.~   "
6818|NCT02968199|"~     This study describes the development of a community-based network to promote smoking~     cessation among female smokers in Hong Kong.~   "
6819|NCT02968186|"~     The objective of this study is to investigate the efficacy of an implementation program~     specifically designed to increase alcohol screening and brief intervention rates in primary~     health care.~   "
6820|NCT02968173|"~     This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the~     safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of~     the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants~     at high risk (infants born at less than or equal to 35 weeks gestational age and less than~     or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age~     with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical~     treatment within the previous 6 months or infants less than or equal to 24 months of age~     with hemodynamically significant congenital heart disease [CHD]).~   "
6821|NCT02968160|"~     This is a Randomized, open-label, 2 groups, parallel design.~   "
6822|NCT02968147|"~     ﻿﻿Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an~     irregular heart beat resulting in symptoms including palpitations and breathlessness. It is~     known that in most cases, AF is caused by abnormal electrical activity from the top of the~     left side of the heart (left atrium) which overrides the heart natural pacemaker in the~     right atrium. Treatment options include tablets which suppress this abnormal electrical~     activity, but in some patients these are not sufficient and a procedure is carried out where~     the areas of abnormal electrical activity are disconnected or 'ablated' to prevent AF from~     occurring. This treatment is well established and performed worldwide, often under general~     anaesthetic (GA). The heart and lungs sit close together in the chest, and when the lungs~     are inflated and deflated during the procedure, the heart also moves. This movement is then~     transmitted to the special wires or 'catheters' that are placed inside the heart to deliver~     the ablation treatment. Instability during the treatment can result in ineffective areas of~     ablation which may later contribute to reduced success of the procedure. Previous research~     has shown that by reducing the movement of the heart under anaesthesia using alternative~     techniques can improve catheter stability and improve procedural results. Once such~     technique is called high frequency jet ventilation (HFJV) which allows the lungs to filled~     with air using fast and shallow breaths resulting in normal blood oxygen levels with little~     movement in the heart. This technique has been shown to be safe and effective for this~     procedure but a direct comparison with conventional ventilation has not been done. The~     investigators wish to test this and determine if using HFJV improves outcomes during the~     procedure (i.e. can investigators do the treatment faster and more effectively) and if this~     translates to better outcomes long term.~   "
6823|NCT02968134|"~     The purpose of this study is to try to find out how critically ill patients receiving the~     anti fungal medication, posaconazole, process it in their body. Investigators would like to~     study if the recommended doses of posaconazole achieve adequate concentrations in the~     patients blood to treat fungal infections.The disease process in critically ill patients can~     profoundly influence the concentration of anti fungal medication in the blood. The process~     by which a drug travels through the body in blood, how it is broken down and removed by the~     body is called pharmacokinetics (PK).~      This information is important to know because if antifungal levels are low in the blood, the~     fungal infection has an opportunity to become resistant to the antifungal medication which~     can lead to the medication being less effective against the fungal infection potentially~     exposing future patients with infection to a limited range of effective antifungals.~      Investigators can measure the PK by taking blood samples at specific times after the anti~     fungal medication is given.~      This study will enroll 8 patients who are admitted to the intensive care unit and are being~     treated with an antifungal medication for a fungal infection. Patients will be consented and~     given a single dose of posaconazole and serial blood samples will be collected just prior to~     the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and~     48 hours . Information about the patients stay in the ICU will also be collected including~     blood pressure, temperature, blood test results.~   "
6824|NCT02968121|"~     To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered~     subcutaneously or intramuscularly in adults with schizophrenia.~   "
6825|NCT02968108|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in~     subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18~     years old in other countries and determine if it is similar to that observed in adults with~     moderately to severely active Crohn's disease (CD). Also to assess the safety,~     immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active~     CD. The main part of the study continues to Week 16, at which point all subjects who are~     receiving benefit from ustekinumab maintenance therapy (as determined by the investigator)~     are eligible to enter the long-term extension (LTE) and continue to receive ustekinumab. The~     study extension ends at Week 220.~   "
6826|NCT02968095|"~     The purpose of this research is to test a text message intervention for people who are~     beginning an attempt to quit smoking. The intervention seeks to teach people to think about~     their cravings to smoke in more helpful ways. The investigators expect that participants~     receiving the text message craving program will be less likely to begin smoking again~     compared to participants in a control condition.~   "
6827|NCT02968082|"~     A Single-center, randomized, prospective, experimental, double-blind comparison study for~     effects of preoperative scopolamine patch application on the postoperative nausea and~     vomiting in microvascular decompression surgery~   "
6828|NCT02968069|"~     Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic~     efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community~     hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous~     lesions.The investigators will conduct a study to develop and validate a diagnostic model~     based on NBI for early gastric cancerous lesions under endoscopic observation.~   "
6829|NCT02968056|"~     There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk~     of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and~     single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting~     of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an~     attractive procedure to improve the treatment of persistent AF. However, only a few centers~     reported their preliminary results, and the conclusions are controversial. The investigator~     previously reported a minimally invasive surgical ablation from left thoracoscope only and~     achieved good results. Recently, the investigator successfully explored a hybrid procedure~     combing this unique surgical technique and transvenous catheter ablation. Here, the~     investigator present a study to evaluate the efficacy and safety of this novel hybrid~     procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation~     alone in the treatment of persistent AF.~      This study is a non-randomized controlled study within a single institution. Isolated~     persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua~     Hospital will be screened for enrollment of this study. The study will recruit 180 patients~     in total. Based on their own willingness, the patients will be divided into hybrid group and~     minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery~     from left thoracoscope as the investigator reported before, while the hybrid group patients~     will have additional transvenous catheter ablation after the surgical ablation is done~     during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that~     each group contains 90 patients. The perioperative data is collected, and the patients will~     be followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post~     operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative~     complications, major cardiovascular events, stroke, left ventricular systolic function,~     medical expense, serum brain natriuretic peptide level and quality of life. The aim is to~     evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more~     evidence of the hybrid strategy in the treatment of persistent AF.~   "
6843|NCT02967874|"~     Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations~     (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and~     thus are potentially important as new therapeutic tools for the repair and regeneration of~     acute and chronically damaged tissues.~      The general objective of this study is to evaluate safety and clinical efficacy of a single~     intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with~     knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic~     agent and intra-articular administration, as a mode of delivery. Expected clinical effects:~     a treatment reduces pain, increases function and reduces stiffness in the knees of~     osteoarthritic subjects.~   "
6830|NCT02968043|"~     Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents.~     Exercise is the most common conservative therapy for mild AIS patients. There are increasing~     evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the~     curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality.~     The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle,~     fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for~     mild AIS patients, and to promote PSSE's application in Shanghai.~      Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each~     subject will be asked to sign an informed consent form before the subject participate in the~     study.~      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the~     intervention group, in which they will perform PSSEs; or the control group, in which they~     will perform generalised physiotherapy exercises. All subjects will be assessed at the~     initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic~     appearance, radiographic measurement, static balance test, pulmonary function test, bone~     quality, and HRQoL will be used.~   "
6831|NCT02968030|"~     Aging is characterized by functional losses among which, the related to mobility and balance~     may be highlighted. Regular physical activity, including muscle strengthening exercises, is~     beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8~     weeks-program of lower limbs strengthening exercises in the balance and functional mobility~     of physically active elderly. The investigators evaluated 18 women, with ages between 61 and~     80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up~     and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of~     the lower limbs, the workload was determined by the strength reached in the eight-repetition~     maximum test (8RM), applying progressive load increments between training sessions conducted~     (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of~     training, with subsequent adjustment of the load for the subsequent training. The training~     took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were~     analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated~     elderly women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035)~     and statistically significant increase in muscle strength were observed in all muscle groups~     trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not~     significantly different after training. Therefore, strength training proposed was efficient~     in improving muscle strength in the lower limbs of irregular physically active elderly,~     impacting positively on functional gain gait. However, the gain in muscle strength was not~     enough to generate significant results in static balance probably due to the type of~     exercise performed as well as due being limited to muscle groups of the lower limbs.~   "
6832|NCT02968017|"~     Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for~     assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth~     Retardation and Fetal Anemia.~      The use of this Doppler measurement in uncomplicated term pregnancies is not a common~     practice due to lack of information. However, several studies use the MCA Pulsatility Index~     (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.~      The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated~     pregnancy.~   "
6833|NCT02968004|"~     This will be an open-label, randomized, multicenter, efficacy and safety study of weekly~     MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone~     deficiency.~   "
6834|NCT02967991|"~     Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals~     in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy~     remains an important method for helping to determine the etiology and stage of LD.~     Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy~     (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic~     ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective~     method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as~     well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-gauge~     needle, therefore in this study the investigators hope to compare the tissue yields of a~     22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The~     investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic~     accuracy, with less visible blood artifact. Similarly the investigators predict the safety~     to be equal.~   "
6835|NCT02967978|"~     The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in~     urine and serum differs between postmenopausal women aged 50 to 75 years suffering from~     osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used~     for the diagnosis of osteoporosis or whether further parameters have to be included.~   "
6836|NCT02967965|"~     CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and~     undergoing reperfusion therapy. Therefore, male and female patients older than 35 years and~     younger than 80 years with onset of chest pain of less than 12 hours who need a primary~     percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be~     recruited.~   "
6837|NCT02967952|"~     In this 3-year successive research plan, investigators will conduct a prehospital randomized~     controlled trial to address the following question: In adult patients with non-traumatic~     cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician~     (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation~     cause a better chance of sustained recovery of spontaneous circulation and other survival~     outcomes like neurologically favorable status, comparing to those who receiving supraglottic~     airway device.~   "
6838|NCT02967939|"~     A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic~     hepatitis B patients~   "
6839|NCT02967926|"~     This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to~     facilitate common bile duct stone removal without fluoroscopy~   "
6840|NCT02967913|"~     The bladder flap at the time of cesarean delivery is the term used to describe the~     separation of the bladder from the lower uterine segment by sharply incising the~     vesico-uterine peritoneum or serosa and using blunt and/or sharp dissection to develop this~     potential space which facilitates placement of a retractor, known as the bladder blade.~     Creating a bladder flap at the time of cesarean delivery is largely based on individual~     practice patterns and practitioners are divided in their use of this step. While creating a~     bladder flap has a theoretical advantage of protecting the bladder from injury, it is~     unknown whether this step has an effect on postoperative bladder function. The purpose of~     this study was to evaluate whether the omission or creation of a bladder flap results in a~     change in urinary symptoms as measured by the UDI-6 component of the PFDI-20.~   "
6841|NCT02967900|"~     An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised~     treatment, over a 16 week period conducted at out-patient level, utilising novel optical~     wound measurement technologies.~   "
6844|NCT02967861|"~     The objective of the study was to evaluate the levels of Peroxisome proliferator-activated~     receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex~     microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and~     Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects~     before and after intervention with pranayama as an adjunct to scaling and root planing.~   "
6845|NCT02967848|"~     This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin~     hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.~   "
6846|NCT02967835|"~     Will Tele-psychiatry be effective and acceptable to patients.~   "
6847|NCT02967822|"~     In order to understand the molecular mechanisms leading to Mayer-Rokitansky-Kuster-Hauser~     syndrome (MRKH), the research team has to identify molecular bases of this anomaly.~      Toward this goal, the research team would like to include in the study patients with MRKH~     syndrome, as well as their healthy relatives, in order to perform genetic analyses,~     especially whole exome sequencing.~      This study has been set up in order to collect biological samples from patients with MRKH~     and their relatives.~   "
6848|NCT02967809|"~     Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves~     the performances diagnose in the bed of patient in department of conventional medicine.~      The concordance between the initial medical diagnosis (previous the utilsation of portable~     echograph) and the final diagnosis (after portable echograph utisation) will be evaluated.~     These evaluation will be performed after retrospective review of the medical files~   "
6849|NCT02967796|"~     The aim of the study is to evaluate in primiparous patients the benefit of supplementation~     with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture.~     The patient is followed from the delivery to 6 to 8 weeks after.~   "
6850|NCT02967783|"~     The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine~     immunization schedules in OPV-only using countries as part of the Global Polio Eradication~     Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in~     the global IPV supply landscape, the GPEI polio eradication program is facing a critical~     shortage of the vaccine which is forecast to continue until at least the end of 2017. The~     shortage means that some countries that have already introduced the vaccine, but which are~     considered to be relatively low risk (The Gambia included), will be left without adequate~     supplies and in other countries IPV introduction is being unavoidably delayed.~      Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR).~     The current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2~     (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a~     large scale IPV campaign will be implemented to increase population immunity to the type 2~     poliovirus in an large area surrounding the outbreak as high risk of extending transmission.~      Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one~     fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning~     purposes, there is an urgent need to assess the practical and logistic challenges a country~     such as The Gambia would face in rapidly undertaking an ID fIPV campaign.~   "
6851|NCT02967770|"~     The purpose of this study is to determine whether molecularly tailored therapy can improve~     the efficacy of treatment when compared to standard chemotherapy combinations for patients~     with metastatic pancreatic cancer receiving their second line of therapy for metastatic~     disease.~   "
6852|NCT02967757|"~     This study is conducted in Europe. The aim of this study is to investigate usage of~     liraglutide for weight management in clinical practice.~   "
6853|NCT02967744|"~     The study investigates associations between pre treatment pain intensity and central pain~     mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.~   "
6854|NCT02967731|"~     This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus~     Drug Depot in adult subjects with chronic sinusitis.~   "
6855|NCT02967497|"~     This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with~     cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK~     wild type non-small cell lung cancer, stage IIIB-IV.~   "
6856|NCT02967484|"~     This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke~     patients.Half of participants will receive Huo Xue San Feng acupuncture combining 1~     antihypertensive medication on the routine ischemic stroke treatments' basis. While the~     other half will receive 1 antihypertensive medication and basic treatments for ischemic~     stroke.~   "
6857|NCT02967471|"~     Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To~     improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS.~     This project aims to detect novel biomarkers from peripheral blood , which can improve the~     early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.~     Clinical data and blood sample were recorded before treatment and after treatment. Acute~     Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at~     enrolment. Different kinds of lymphocytes from blood samples would be detected by flow~     cytometry ,which could be used for discovering high sensitivity and specificity ARDS~     biomarker.~   "
6858|NCT02967458|"~     This is a phase II single center study using contrast-enhanced ultrasound to identify~     aggressive forms of prostate cancer with subharmonic imaging.~      The following are the study objectives:~        1. To implement subharmonic imaging technology on a transrectal probe suitable for~          prostate imaging and biopsy~        2. To demonstrate visualization of prostatic vascularity using subharmonic~          contrast-enhanced imaging.~        3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced~          subharmonic imaging for detection of clinically significant PCa.~      The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will~     receive an intravenous infusion of microbubble contrast material immediately prior to a~     prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a~     microbubble contrast agent allows for detection of clinically significant prostate cancer.~   "
8078|NCT02951481|"~     The purpose of this study is to determine whether a bundle of measures specifically designed~     for patients with ICD and applied by and Infectious Diseases expert during a year period~     (2017) will improve the prognosis and reduce the rate of recurrence, compared with the~     baseline phase (2015) in which no intervention was made.~   "
6859|NCT02967445|"~     Cervical insufficiency, previously referred to as cervical incompetence, has classically~     been defined as painless dilation of the cervix in the absence of contractions or bleeding~     in the second trimester resulting in recurrent pregnancy losses. Painless mid-trimester~     cervical dilation is an uncommon finding in the general population occurring in less than 1%~     of pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm~     births and/or second trimester losses, as well as second trimester cervical dilatation in~     the index pregnancy, was first reported in the 1950's. Cerclage placement in this setting~     has been variably referred to as physical exam-indicated cerclage, rescue cerclage, and~     emergency cerclage. To date, the benefits of cerclage for this indication are not entirely~     clear.~      A recent meta-analysis showed that physical exam-indicated cerclage is associated with a~     reduction in perinatal mortality and prolongation of pregnancy when compared to no such~     cerclage.~      Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB~     in several populations.~      Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary~     compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester~     cervical dilation~   "
6860|NCT02967432|"~     The purpose of this study is to determine whether or not mupirocin treatment results in S.~     aureus decolonization in affected NICU patients.~   "
6861|NCT02967419|"~     The purpose of this study is to find out the possible relationship among TWEAK/Fn14,~     JAK/STAT3 and IDO as well as their roles in the dysfunction of immune micro-environment of~     endometrium in people diagnosed as repeated implantation failure after in vitro~     Fertilization-embryo transfer(IVF-ET).~      We will use the technology of Western-blot and Immunohistochemistry to find out the~     relationship of the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium . Also, we~     will use technology of Western-blot and Immunohistochemistry to determine whether there are~     differences of the the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium between~     RIF group and control group.~   "
6862|NCT02967406|"~     This is a community-based cluster randomized control trial aimed to investigate the impact~     of lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the~     development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive~     pulmonary disease and cardiovascular disease in an intermediate risk population in mixed~     urban-rural areas of Ubon Ratchathani.~   "
6863|NCT02967393|"~     This study is designed to note whether a larger safety study using quadrivalent live~     attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine~     (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients~     in this study will receive the FLUARIX® influenza vaccine, while the other half will receive~     a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used~     as a surrogate for LAIV4.~   "
6864|NCT02967380|"~     This pilot clinical trial compares gadobutrol with standard of care contrast agents,~     gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced~     (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade~     II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast~     agent that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of~     the central nervous system. It is not yet known whether gadobutrol is more effective than~     standard of care contrast agents before DCE-MRI in diagnosing patients with multiple~     sclerosis, grade II-IV glioma, or tumors that have spread to the brain.~   "
6865|NCT02967367|"~     During last years, numerous sleep trackers have been commercialized. They are intended to~     give indications about sleep quality/duration in order to give people an internet-based~     feedback about their own sleep.~      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used~     routinely to assess objective sleep quality/patterns. Their use is also validated to~     estimate sleep in obstructive sleep apnea syndrome (OSA).~      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers~     and validated tools to measure sleep in OSA patients.~   "
6866|NCT02967354|"~     Cross-sectional study to investigate subjects at different stages of type 2 diabetes~     development with expected stratification of pancreatic islet mass. Non-diabetic individuals~     were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and~     retention in the pancreas as a surrogate marker for the endogenous islet mass.~   "
6867|NCT02967341|"~     To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic~     studies of ciprofloxacin in patients under treatment for childhood cancer.~   "
6868|NCT02967328|"~     Immature platelets—also termed reticulated platelets (RP)—are platelets newly released into~     the circulation, and have been associated with a variety of pathological bleeding events~     including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry~     (FCM) after staining with thiazole orange (TO) at low concentration and expressed as a~     fraction of the total platelet count (RP%). The diagnosis of primary ITP is based on~     differential diagnosis and the measurement of RP% can serve as an alternative diagnostic~     test that are useful in daily practice. Our study aimed at distinguishing primary ITP from~     other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced~     thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement~     between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen~     (MAIPA) were analyzed accordingly.~   "
6869|NCT02967315|"~     The purpose of this study is to evaluate the correlation between fluid volume status and~     right ventricular volume and function, in those with free pulmonary valve insufficiency~     after Tetralogy of Fallot (TOF) repair.~   "
6870|NCT02967302|"~     To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint~     tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine,~     a standard steroid or placebo.~      The primary hypothesis is that i.a. morphine results in significantly lower pain scores and~     supplemental analgesic consumption than placebo during the first week after injection, an~     efficacy comparable to standard i.a. steroid (triamcinolone) medication.~   "
6871|NCT02967289|"~     The trial is a phase III, multicenter, open-labeled randomized trial comparing the~     association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus~     oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk~     stage III colon cancer in the adjuvant setting.~   "
6872|NCT02967276|"~     This phase II trial study assessing the activity of metformin when given together with high~     dose of dexamethasone in treating patients with multiple myeloma (MM) that has relapse or~     refractory to previous treatment. High dose of dexamethasone (HDdexa) is used to treat~     relapse/refractary patients with myeloma and metformin also demonstrated synergistic~     activity with dexamethasone to eradicate MM cells in vitro and in vivo. Metformin~     hydrochloride, used for diabetes, may also help kill tumor cells. Giving dexamethasone with~     metformin may kill more MM cells and increase the response rate to HDdexa.~   "
6873|NCT02967263|"~     -  To investigate the etiology and epidemiology of acute kidney injury (AKI).~        -  To find out risk factors associated with the occurence of AKI.~        -  To find out risk factors related to the prognosis of AKI,focusing on uremic toxins,~          inflammation, oxidative stress and nutritional status.~        -  To study on the relationship between gene polymorphism and prognosis of acute kidney~          injury.~   "
6874|NCT02967250|"~     The objective of this study is to understand the bioenergetic impairments that underlie~     Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial~     function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will~     result in increased brain ATP levels in individuals with Parkinson's disease (PD). The~     specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and~     after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure~     cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with~     PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day)~     simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a~     pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral~     measurements of UDCA (and associated conjugates) and peripheral measures and/or central~     (brain) bioenergetic measurements.~   "
6875|NCT02967237|"~     Primary Objective:~      The primary objective is to describe the effect of insulin glargine (U300) in type 2~     diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and~     eligible for basal switching, according to the Physician decision, on glycated hemoglobin~     (HbA1c) improvement.~      Secondary Objectives:~        -  Evolution of fasting plasma glucose~        -  Evolution of insulin dose and body weight~        -  Hypoglycemia incidence~        -  Safety~        -  Patients satisfaction when they change their insulin for HOE901-U300~   "
6876|NCT02967224|"~     Primary Objective:~      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy~     measured as glycosylated hemoglobin (HbA1c) change~      Secondary Objectives:~        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if~          noninferiority is met, measured as HbA1c change.~        -  To compare Toujeo to other standard of care basal insulin in terms of patient~          persistence with assigned basal insulin therapy with or without intensification.~        -  Risk of hypoglycemia including the incidence of documented symptomatic or severe~          hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on~          Hypoglycemia).~        -  Change in fasting plasma glucose (FPG).~        -  Change in body weight.~        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction~          Questionnaire Status and Change Versions (DTSQs and DTSQc).~        -  Change in hypoglycemic control subscale (HCS)~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other health care provider visits and healthcare costs.~   "
6877|NCT02967211|"~     Primary Objective:~      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy as~     measured by glycated hemoglobin (HbA1c) change~      Secondary Objectives:~        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if~          non-inferiority criterion is met, measured by HbA1c change.~        -  To compare Toujeo to other standard of care basal insulin in terms of patient~          persistence with assigned basal insulin therapy with or without intensification.~        -  Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or~          severe (according to ADA Working Group).~        -  Change in fasting plasma glucose (FPG).~        -  Change in body weight.~        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction~          Questionnaire Status and Change versions (DTSQs and DTSQc).~        -  Change in hypoglycemic control subscale (HCS).~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other health care provider visits and healthcare costs.~   "
6878|NCT02967198|"~     The purpose of this study is to determine whether fusion technique of preradiofrequency~     ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time~     ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver~     tumor in comparison with ultrasonography guidance alone. And assessment of a new point~     shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing~     liver stiffness (LS) with another pSWE technique (ARFI).~   "
6879|NCT02967185|"~     The proposed study will examine changes in older insomniacs' cognitive functioning following~     behavioral treatment for insomnia using a combination of two methods. A traditional repeated~     measures design will be used to look at group level differences based on performance on a~     neuropsychological battery administered prior to, immediately after, and 3 months after~     completing a 4 week behavioral treatment program for insomnia. This data will be analyzed~     using standard repeated measures analytic techniques. A time-series design will also be used~     to look at within-subject differences based on a brief cognitive battery that will be~     self-administered on a daily basis. Data from this daily battery will be examined using~     intraindividual variability modeling.~   "
6898|NCT02966925|"~     Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms~     of vaginal atrophy include dryness, itching, burning and dyspareunia.~      This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to~     hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from~     reference treatments (hormonal therapies).To achieve this, 20 patients suffering from~     vulvovaginal dryness will be treated with one session of injections in the vulva, the~     posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of~     vaginal dryness will be primarily appreciated through Friedmann score and pH value, and~     secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1,~     3 and 6 months after the treatment.~   "
41979|NCT02506465|"~     The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as~     compared to control group (catheter only).~   "
6880|NCT02967172|"~     The purpose of this study is to determine the efficacy and safety of a peri-articular~     multimodal injection for post-operative pain control following operative management of~     closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive~     or not receive intra-operative injections in addition to standard opioid analgesic regimens.~     Patients will be treated with standard of care surgical techniques by the treating~     orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized~     into the injection cohort will receive a 25cc intra-operative injection with 200 mg~     ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep~     peri-incisional tissues while under general anesthesia. Total post-operative opioid~     consumption expressed in morphine equivalent dose will be recorded, including IV and oral~     opioids. Time in hours from operation conclusion to discharge and discharge disposition (to~     where the patient is discharged) will also be recorded. Post-operative pain scores will be~     assessed and recorded in the immediate post-operative period and every 4 hours subsequently~     until the patient is discharged. Medication related side effects will be monitored. The~     investigators hypothesize that the injection cohort will have reduced pain scores, lower~     narcotic requirements, shorter length of stay, and be more likely to discharge to home~     following surgery.~   "
6881|NCT02967159|"~     AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor~     (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary~     disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor~     agonist with the potential for once daily treatment of asthma and COPD in fixed dose~     combination (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be~     the first clinical study for the combination exposure of AZD7594 with abediterol as 2~     compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This~     study will be conducted in healthy male subjects to minimize the effects of concomitant~     disease states or medications on study measurements.~   "
6882|NCT02967146|"~     Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and~     chitosan(Mediclore®) after axillary dissection for breast cancer~   "
6883|NCT02967133|"~     The optimal prioritization of second-line chemotherapy and immune therapy based on~     demographic or biomarker data is an area of ongoing investigation. The hypothesis of this~     study is that there may be an additive or synergistic antitumor effect of combined~     chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to~     test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need~     despite recent clinical research progress. Early progression for a subset of NSCLC patients~     receiving nivolumab is a specific area of clinical need.~   "
6884|NCT02967120|"~     The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic~     reagents in early diagnosis of oral cancer.~   "
6885|NCT02967107|"~     Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection~   "
6886|NCT02967094|"~     Study was designed to evaluate efficacy of mucolytic solution ingested before upper~     endoscopy on visibility of gastric mucosa.~   "
6887|NCT02967081|"~     The purpose of this study is to determine whether dentinal fluid (tooth fluid) of teeth with~     or without a painful inflammatory condition in their nerve (pulp) contain inflammatory~     marker.~   "
6888|NCT02967068|"~     The purpose of this study is to collect existing tissue specimens from subjects enrolled in~     Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens~     and linked clinical data collected through VCRC studies may lead to the identification and~     development of a series of translational research projects. Results of these studies will~     provide vasculitis researchers with insight into the causes of these diseases and generate~     new ideas for diagnostic tests and therapies, and will be of great interest to the larger~     communities of researchers investigating vasculitis and other autoimmune, inflammatory, and~     vascular diseases.~   "
6889|NCT02967055|"~     This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of~     isotretinoin on the etonogestrel (ENG) contraceptive implant.~   "
6890|NCT02967042|"~     Chronic kidney disease (CKD) is an increasing public health problem and the number of~     patient with chronic kidney disease is increasing worldwide. Bone abnormalities are found~     almost universally in patients with CKD requiring dialysis and in the majority of patients~     with CKD stages 3-5. Chronic kidney disease-mineral bone disorder (CKD-MBD) is a complex~     disorder of bone and mineral metabolism, which is associated with disorder in circulating~     levels of hormones and development of secondary hyperparathyroid disease. The abnormalities~     of mineral homeostasis impair bone remodeling and mineralization and results in cortical and~     trabecular defects and an increased fracture risk. There is also an association with~     increased morbidity and mortality. CKD-MBD is also associated with development of~     calcification of the blood vessels. During the last decade it has been increasingly~     acknowledged that mineral and bone disorder contribute to the excessively high~     cardiovascular morbidity and mortality in patients with chronic kidney disease. The~     pathophysiology behind the disorder varies a lot and can be divided into three groups; high~     turnover renal bone disease, low-turnover disease and mixed-uremic osteodystrophy. The~     treatment of CKD-MBD depends of the subtype of the disorder.~      The diagnosis of CKD-MBD is still challenging. Biomarkers such as parathyroid hormone (PTH)~     and alkaline phosphatase (ALP) are used to evaluate bone turnover and formation, but both~     biomarkers have several limitations and are both unspecific. Many biomarkers have been used~     in research applications, but yet none of them is in clinical use. Dual X ray absorptiometry~     (DXA) is used to measure fracture risk in patients with normal kidney function, but is not~     useful in patients with chronic kidney disease stage 3 - 5. Different imaging techniques~     have been investigated, but still bone biopsy is the golden standard for diagnosing and~     classification of the subtypes of CKD-MBD. Bone biopsy is invasive and is not available in~     every center.~      This study`s goal is to evaluate, if 18-Fluor-Positron emission tomography-computed~     tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is~     that 18-PET-TT correlates with the histomorphometry of bone biopsy and with the~     calcification score in CKD patients and that 18F-PET-TT maybe can be used as a diagnostic~     imaging technique in the future.~   "
6899|NCT02966912|"~     The objective of this study is to investigate whether nutritional supplementation with~     magnesium can improve cardiovascular structure and function in participants with obesity -~     with a long-term goal of preventing clinical heart failure. Specifically, in a randomized~     open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation~     (versus no supplementation) for 24 weeks in obese patients will improve left ventricular~     (LV) mass.~   "
6900|NCT02966899|"~     The goal of this study is to elucidate the relationship between myocardial right ventricular~     triglyceride content (steatosis) and right ventricular dysfunction in participants with~     pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty~     acid treatment.~   "
8204|NCT02949843|"~     This phase II trial studies how well targeted therapy works in treating patients with~     incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other~     genetic mutations or other specific proteins may work better when a patient has cancer~     caused by a driver mutation and the treatment that targets that mutation stops working.~   "
6891|NCT02967029|"~     For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide~     effective controlled hypotension to reduce blood loss and provide a relatively blood-free~     surgical environment to facilitate surgery.~      The goal of controlled hypotension is to maintain an arterial blood pressure which is~     sufficiently low to allow a reduction in bleeding with offering a superior intraoperative~     hemodynamic stability during stressful surgical events to maintain intact cerebral~     microcirculatory auto-regulation.~      Auto-regulation impairment during controlled hypotension might increase oxygen extraction~     ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation~     becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a~     routine basis.~      Various recent studies reported based on facilitating the induction of controlled~     hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its~     effects on postoperative cognitive function are still poorly characterized. Moreover, the~     relationship between rSO2 and controlled hypotension has not been established in patients~     undergoing FESS.~      Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is~     clinically most broadly spread technique, can be used for non-invasive assessment of~     cerebral perfusion by detecting changes in rSO2 by online monitoring of cerebral~     oxygenation.~      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are~     the most commonly used hypotensive agents. The aim of this prospective randomized single~     blind study was to investigate the influence of remifentanyl as a hypotensive agent in~     comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients~     undergoing FESS.~   "
6892|NCT02967016|"~     To the best of the investigators knowledge the average level of physical activity (PA) of~     parturients recovering from a cesarean delivery or after a normal spontaneous vaginal~     delivery (NSVD) remains unknown. Taking in consideration that parturients are in a~     hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most~     common causes of maternal morbidity and mortality, ambulation is of utmost importance to~     anesthesiologists as well as obstetricians. In order to promote mobility, first the~     investigators need to learn the average parturients level of physical activity in the~     immediate post-partum period and up to 48 hours after delivery. This information may help us~     promote mobility in the immediate postpartum period, particularly for those that underwent a~     cesarean delivery since they are at higher risk of VT.~   "
6893|NCT02966990|"~     The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves~     functional standard or correction of deformities. There is a lack of studies that analyze~     the biomechanical changes promoted by the Orthotics in functional pattern of the upper limb.~     The objective of this proposal is to analyse biomechanical changes in the functional upper~     limb pattern with the use of orthoses for patients with dysfunctions arising from~     musculoskeletal system trauma or burns, aiming to contribute with scientific evidence to~     clinical practice. The project will analyze the changes in the pattern of the upper limb~     functional through the use of dynamic and static Orthotics by means of kinematic and~     electromyographic analysis while conducting a functional task. These comparisons will be~     carried out with and without the use of functional Orthotics, and the controls are the~     patients themselves. Methods: 25 patients will be included over 18 years with malfunctions~     resulting from orthopaedic trauma and Burns of the upper limb with indication and Orthotics~     for improving functional pattern. For characterization of the sample will be performed:~     esthesiometric , hand and the (Disabilities of the Arm, Shoulder and Hand) DASH~     Questionnaire. Biomechanical assessment will be used for the analysis and electromyographic~     kinematics. For statistical analysis will be applied the method of analysis of variance~     (ANOVA) for repeated measures, and when necessary, the post hoc Bonferroni test. Will be~     adopted as significance level p ≤ 0.05.~   "
6894|NCT02966977|"~     The aim of this study is to evaluate the effect of an extension of conventional urine~     diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is~     done directly from the urine sample (without an intermediate bacterial culture).The primary~     outcome is the time from the entry of a urine sample in the microbiological laboratory to~     the adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a~     therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a~     comparison of the length of hospital stay.~   "
6895|NCT02966964|"~     The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2~     group or control group randomly.~      All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day~     for 48 weeks. At the same time, all randomized subjects take two pills of Ursa® Tab. or~     Placebo of Ursa® Tab. twice a day for 48 weeks.~   "
6896|NCT02966951|"~     Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed~     with Knee osteoarthrosis~   "
6897|NCT02966938|"~     Food allergies are constantly increasing. Peanut and nut allergies are a major cause of~     allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that~     had an allergic reaction have another one in the following year with the same food, despite~     a real improvement in industrial products labeling.~      The investigators have observed in the allergy Unit that patients (and/or their family)~     following an elimination diet, sometimes since several years, use very strict elimination~     strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet,~     a good identification of the allergen is the key to a successful elimination and the~     non-identification a known risk factor.~      Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were~     allergic to. However, this is a US study, and geographical specificities have an impact on~     food consumption and culture. Food allergology needs to take those two elements into~     account. For example, in France, a single food can have two names. It is the case of peanut,~     which can be called arachide, or more frequently cacahuète.~      The goal of the study is to observe patient aptitudes to recognize peanut (and the~     association between the two names) and other nuts available in France and define by the~     European law, using a plate with various food samples in seed or in shell.~      Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and~     their families were surveyed with a standardized procedure at the beginning of their~     therapeutic education and their capacity to recognize various nuts, to identify peanut~     (cacahuète or arachide) and to associate the two words cacahuète and arachide was~     assessed. It is a standard procedure in therapeutic education, and the responses have been~     systematically entered in the medical record.~      The main objective of this study is to describe peanut or nut allergic patient capacity~     (adult, children and/or the family) to visually identify the foods there are allergic to.~      The secondary objective of this study is to describe the capacity of patient that describe~     themselves as allergic to arachide to associate this word to the word cacahuète.~   "
6942|NCT02966353|"~     This is a study of treatment with ruxolitinib in patients who present with transfusion~     dependent or independent anemia with 10 mg BID starting dose and subsequent up titrations~     depending on safety and efficacy.~   "
6943|NCT02966340|"~     Double-blind, placebo-controlled, cross-over design study examining the effects of a~     norepinephrine alpha1 receptor antagonist (prazosin) on stress reactivity in a laboratory~     stressor task.~   "
6901|NCT02966886|"~     The primary objective of this study is to determine the difference in disease specific~     quality of life outcome measures between patients diagnosed with osteoarthritis of the~     shoulder joint whom require a total shoulder replacement between the following study arms:~     1)TSA using an augmented component compared with TSA using a standard component with~     eccentric reaming in patients 65 years of age or younger or 2) TSA using an augmented~     component or reverse shoulder arthroplasty in patients older than 65 years of age as~     measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score at~     post-operative time intervals (ie. 3, 6, 12 and 24 months).~      The secondary objective is to determine the difference in disease specific quality of life~     between treatment allocations in both age groups as measured by the Constant score, the~     American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the~     EuroQol Group EQ-5D-5L score at post-operative time intervals (ie. 3, 6, 12 and 24 months).~      A secondary objective will be to determine the survivorship of the components as measured by~     the degree of radiographic lucencies and component alignment determined by a CT scan at 1~     and 5 years post-surgery between study allocations in both age groups.~   "
6902|NCT02966873|"~     This is a randomized controlled Phase II clinical trial designed to evaluate the effects of~     N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic~     Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.~   "
6903|NCT02966860|"~     A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects~     under fasted conditions~   "
6904|NCT02966847|"~     In the coming years, an increase in lung nodule resection is expected, particularly in~     Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a~     device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a~     tool whose use is constantly spreading.~   "
6905|NCT02966834|"~     This study is being conducted to evaluate the efficacy, safety and tolerability of~     GSK2330672 administration for the treatment of pruritus (itch) in participants with primary~     biliary cholangitis (PBC). Participants will be treated with either placebo or one of the 4~     dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg~     twice daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding.~     The total duration of a subject's participation will be up to 45 days of screening and 24~     weeks of study including follow-up.~   "
6906|NCT02966821|"~     A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of~     sulfatinib as a second-line treatment in patients with surgically unresectable or metastatic~     biliary tract carcinoma~   "
6907|NCT02966808|"~     Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in~     almost 93% of patients in the first 15 years of the disease, being a clear problem for their~     normal living. Nevertheless, therapeutic options for this symptom are few and optimal for~     only some patients.~   "
6908|NCT02966795|"~     A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir~     (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants~     with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without~     compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with~     interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined~     as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined~     as SOF plus RBV treatment-experienced).~   "
6909|NCT02966782|"~     This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the~     safety, pharmacokinetics, and efficacy of venetoclax as a single-agent and in combination~     with azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after~     Hypomethylating Agent (HMA)-Failure.~   "
6910|NCT02966769|"~     The objective of this multicenter retrospective study is to compare overall survival in~     patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus~     definitive chemoradiation.~      Secondary objectives are to analyze disease-free survival, median survival, locoregional and~     distant relapses as well as mortality and toxicity related to treatment.~   "
6911|NCT02966756|"~     This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of~     venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in~     the presence of 17p deletion.~   "
6912|NCT02966743|"~     Compare the changes of regional cerebral oxygen saturation during midazolam or~     dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur~     surgery.~   "
6913|NCT02966730|"~     The purpose of this study is to find out how successful ibrutinib is at putting follicular~     lymphoma into full remission. In this study, remission will be determined by achieving a~     normal PET scan after treatment. A PET scan is an imaging test that looks for active~     lymphoma. People who don't have a complete remission on PET after their first treatment are~     at high risk for having their lymphoma return. This study will investigate if ibrutinib will~     help participants achieve a complete remission without giving additional chemotherapy. The~     study will also investigate any possible side effects of the study drug ibrutinib.~   "
6914|NCT02966717|"~     Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of~     factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to~     be the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid~     therapy in clinic often induces some problems such as hormone dependent and hormone~     resistance, as well as severe side effects which act as a threat to the patients' health.~     Besides, patients with proteinuria long-term not control often behave faster progression~     into chronic renal failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX)~     is often used in the treatment of refractory nephropathy, such as hormone dependent~     nephrotic syndrome, hormone resistance nephrotic syndrome, frequency recurrence nephrotic~     syndrome, which shows exciting effects in delaying the development of the disease.At~     present, mesenchymal stem cells ( MSCs) has been used as a research hotspot to repair the~     tissue damage of chronic kidney disease, and it also behaves certain effects. The purpose of~     this study is to seek a more targeted treatment, more precise curative effect and more~     feasibility treatment for PNS(CKD3-4),so as to delay or reverse the disease and improve the~     quality of life of patients with CKD.~   "
6984|NCT02965794|"~     EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED~     FOR COLORECTAL SURGERY~   "
6915|NCT02966704|"~     The evaluation of protein quality has been identified as the top priority question by the~     Food and Agricultural Organization (FAO) of the United Nations. However, the current~     available methods do not precisely estimate protein quality, or need invasive procedures.~     The proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in~     humans.~      The present project characterizes the use of 15N-intrinsically-labelled milk protein as a~     reference-protein for development a non-invasive method that can be used to assess protein~     quality in human subjects~   "
6916|NCT02966691|"~     This clinical study is designed to evaluate the diagnostic performance of VisioCyt test,~     which would improve the early diagnosis of bladder cancer in order to optimize the~     management of individual patients as part of a cancer diagnostic monitoring. The diagnostic~     method of VisioCyt® device is based on the analysis by transmission and fluorescence, of~     urinary cytology slides prepared according to the protocol VisioCyt.~   "
6917|NCT02966678|"~     Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control~     population. However, the actual incidence rate is not investigated.~   "
6918|NCT02966665|"~     Many control mechanisms exist which successfully match the supply of blood with the~     metabolic demand of various tissues under wide-ranging conditions. One primary regulator of~     vasomotion and thus perfusion to the muscle tissue is the host of chemical factors~     originating from the vascular endothelium and the muscle tissue, which collectively sets the~     level of vascular tone. With advancing age and in many disease states, deleterious~     adaptations in the production and sensitivity of these vasodilator and vasoconstrictor~     substances may be observed, leading to a reduction in skeletal muscle blood flow and~     compromised perfusion to the muscle tissue. Adequate perfusion is particularly important~     during exercise to meet the increased metabolic demand of the exercising tissue, and thus~     any condition that reduces tissue perfusion may limit the capacity for physical activity. As~     it is now well established that regular physical activity is a key component in maintaining~     cardiovascular health with advancing age, there is a clear need for further studies in~     populations where vascular dysfunction is compromised, with the goal of identifying the~     mechanisms responsible for the dysfunction and exploring whether these maladaptations may be~     remediable. Thus, to better understand the etiology of these vascular adaptations in health~     and disease, the current proposal is designed to study changes in vascular function with~     advancing age, and also examine peripheral vascular changes in patients suffering from~     chronic obstructive pulmonary disease (COPD), Sepsis, Pulmonary Hypertension, and~     cardiovascular disease. While there are clearly a host of vasoactive substances which~     collectively act to govern vasoconstriction both at rest and during exercise, four specific~     pathways that may be implicated have been identified in these populations: Angiotensin-II~     (ANG-II), Endothelin-1 (ET-1), Nitric Oxide (NO), and oxidative stress.~   "
6919|NCT02966652|"~     DITEST is an oral formulation of native testosterone for the treatment of androgen~     deficiency in men. The proposed study is a Phase 1 clinical study in hypogonadal men,~     defined according to FDA and Endocrine Society Guidelines, designed to evaluate the~     pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of~     DITEST in the target population.~   "
6920|NCT02966639|"~     The main objective of this study is the external validation of the appropriateness criteria~     for the surgical treatment of Lumbar Degenerative Spondylolisthesis. We will assess,~     prospectively, whether patients treated appropriately have better outcomes than those~     treated inappropriately according to the RAND Appropriateness Method (RAM) Criteria.~   "
6921|NCT02966626|"~     Type 2 diabetes is creating a health pandemic globally. Management of type 2 diabetes~     involves combination of lifestyle intervention and drug intervention, which includes~     sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin~     (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes~     in 2014. This study will describe the characteristics of patients who are prescribed~     dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe~     their glycaemic control, weight, and renal function at baseline and during use of~     dapagliflozin.~   "
6922|NCT02966613|"~     To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with~     fully disposable patient-specific instrumentation versus conventional, versus patient~     specific instrumentation.~   "
6923|NCT02966600|"~     The aim of this randomized controlled trial was to assess the impact of progressive~     resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The~     investigators hypothesized the intervention would have a beneficial effect on the study~     outcomes.~   "
6924|NCT02966587|"~     This phase II trial studies how well durvalumab works in treating patients with prostate~     cancer that is resistant to hormones and has spread to other places in the body. Monoclonal~     antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and~     spread.~   "
6925|NCT02966574|"~     Whole-body MRI including diffusion is a booming technique. Numerous studies have~     demonstrated its interest in metastatic cancers. Breast cancers, especially~     hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic~     site.~      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides~     quantitative functional criteria (diffusion and ADC values). According to a recent study,~     whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the~     diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.~      Therefore, it seems appropriate to study the performance of whole body MRI in the~     pre-therapeutic assessment of breast cancer with a high risk for metastasis and the~     monitoring of metastatic breast cancer.~   "
6926|NCT02966561|"~     The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled~     trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI)~     during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity~     (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a)~     instruction on how, where and when to perform the behavior, b) prompt goal setting for~     physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The~     primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time~     period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as~     well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA~     progression after PR, a complex personal diagnostic, including questionnaires as well as~     functional assessments, is to be carried out at the start (T1 = start of study phase II) and~     end of PR (T2). This diagnostic is based on the main ideas of the PA-related health~     competence model (PARC-model) and especially incorporates physical and psychological~     personal determinants of PA.~   "
6927|NCT02966548|"~     This study will be used to determine the safety and tolerability of BMS-986016 administered~     alone and in combination with Nivolumab in subjects with advanced solid tumors.~   "
8205|NCT02949830|"~     The purpose of this study is to determine the long-term safety, tolerability and~     pharmacokinetics of ALN-AS1 in AIP patients~   "
6928|NCT02966535|"~     Gas exchange disturbance frequently occurs in steep Trendelenburg position during~     robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic~     pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity,~     hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory~     time during mechanical ventilation has been reported to be improve gas exchange in adult~     respiratory distress syndrome. The investigators attempt to test the hypothesis that~     prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic~     urologic surgery.~   "
6929|NCT02966522|"~     To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac~     involvement~   "
6930|NCT02966509|"~     The Engagement of Patients with Advanced Cancer is an intervention that utilizes~     well-trained lay health coaches to engage patients and their families in goals of care and~     shared decision-making after a diagnosis of advanced cancer. Although lay health workers~     have never been tested in this role, we hypothesize that lay health workers can feasibly~     improve goals of care documentation and help to reduce unwanted healthcare utilization at~     the end of life for Veterans diagnosed with new advanced stages of cancer and those~     diagnosed with recurrent disease.~   "
6931|NCT02966496|"~     This trial is designed to compare the biocompatibility and long-term visual outcomes of the~     Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract.~     The aim is to provide a safer biomaterial for senile cataract treatment, achieving better~     postoperative visual quality and fewer complications.~   "
6932|NCT02966483|"~     Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior~     alternative regarding resection quality, and oncological outcomes of patients as compared to~     open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over~     open surgery with regard to operative invasiveness, patient's recovery, and wound related~     complications. Thus, laparoscopic surgery has gained great popularity over the past decades.~     However, specifically for mid and low rectal cancer, laparoscopic surgery is technically~     demanding, which sometimes leads to high morbidity and unsatisfactory resection quality,~     especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated~     pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so~     called down-to-up alternative, has emerged as a promising solution to these problems in~     recent years and more and more small studies have proven the feasibility and advantages of~     this technique, making it become a hot topic among both literature and conferences. However,~     TaTME is still at early birth, higher-level evidences, either multicentric, or comparative~     study with conventional surgery is strikingly lacking. Thus the investigators conduct this~     multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for~     mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better~     resection quality and result in non-inferior oncological outcome, as well as short term~     operative morbidity and mortality.~   "
6933|NCT02966470|"~     This study aims to assess if grip strength can be used as a single, objective surrogate of~     frailty assessment in the surgical population.~   "
6934|NCT02966457|"~     MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of~     bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It~     was previously shown, that intestinal colonization with extended-spectrum β-lactamases~     (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.~     baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients~     with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I.~     et al., 2016].~      To the investigators knowledge no randomized, placebo-controlled clinical trial has been~     performed to study the efficacy and safety of selective intestinal decolonization strategies~     in high-risk patients with haematological malignancies. Possible decolonization of MDR~     gram-negative bacteria in haematological patients could be important for the patient by~     reducing the risk of infection and for the community by reducing the risk of transmission.~      The purpose of the proposed study is to assess the efficacy and safety of selective~     intestinal decolonization of MDR gram-negative bacteria with oral administration of~     Colistimethate sodium in high risk patients with haematological malignancies.~   "
6935|NCT02966444|"~     This study evaluates the effects of dietary fatty acid composition from high fat meals on~     markers of hunger, satiety and metabolism.~   "
6936|NCT02966431|"~     Determine the effects of an 8-week weight loss intervention.~   "
6937|NCT02966418|"~     The purpose of this study is to assess whether a large clinical trial testing the effect of~     mild hypoxia preconditioning on neurologic outcome in patients undergoing interventional~     treatment is warranted.~   "
6938|NCT02966405|"~     A descriptive analysis involving 300 healthy pregnant women to the establish of~     trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were~     selected as the normal pregnant population to establish a self-sequential longitudinal~     reference range.~   "
6939|NCT02966392|"~     The purpose of the study is to determine whether automated cuff pressure control results in~     a reduction in the proportion of patients developing ventilator associated respiratory~     infections during their stay in intensive care.~   "
6940|NCT02966379|"~     Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO~     electrode lead has been specifically designed to preserve this residual hearing through~     surgery. It is then possible to provide the patient with a electro-acoustic stimulation~     (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing~     and an electrical stimulation through the cochlear implant. The major aim of this study is~     to evaluate hearing preservation after implantation with the EVO electrode lead.~      The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra~     speech processor.~   "
6941|NCT02966366|"~     Recent studies have reported successful reduction of tinnitus after cochlear implantation~     (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not~     fully understood. Especially, the relative role of peripheral and central auditory pathways~     is not clearly known. This study assessed the effect of CI electrical stimulation on~     tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and~     relative contributions of peripheral and central auditory pathways in tinnitus reduction.~   "
41980|NCT02506452|"~     The purpose of this study is to compare the wound closure outcomes of subjects receiving~     diabetic foot ulcer treatment with and without the use of Biovance®.~   "
6944|NCT02966327|"~     Objectives: 1) To evaluate the effect of early compression therapy with individualized~     exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients~     treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate~     the effect of early compression therapy with individualized exercise on lower limb volume,~     quality of life and incidence of cellulitis infections at 12 months post-operatively in this~     population.~   "
6945|NCT02966314|"~     The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to~     2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced~     angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be~     life- threatening especially when affecting tissues within the respiratory tract. No clear~     guidelines exist for management of this important condition for clinicians. Current~     therapies typically include avoidance of potential triggers and use of medications either~     for prophylaxis or for acute events, such as antihistamines, corticosteroids, and~     epinephrine. There remains a critical need for therapeutic options to provide more effective~     prophylaxis.~   "
6946|NCT02966301|"~     This study aims to evaluate the early chronic GvHD events (first line therapy), if the~     addition of arsenic trioxide to standard therapy with corticosteroids, with or without~     cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of~     corticosteroid therapy~   "
6947|NCT02966288|"~     The study objective is to determine whether a single intra-articular dose of an~     anti-inflammatory (Toradol) will reduce the need for other analgesic medications and, if so,~     how long the benefits will last.~   "
6948|NCT02966275|"~     This study is to test our automated hypoglycemia prevention and treatment device~     (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that~     are experiencing symptoms of hypoglycemia.~   "
6949|NCT02966262|"~     All comer registry who had undergone intravascular optical coherence tomography during~     and/or after coronary intervention.~   "
6950|NCT02966249|"~     The present study is designed to evaluate and compare the efficacy of intrathecal~     dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's~     intravenous administration, without loading dose, additionally to spinal anaesthesia, in~     patients undergoing total knee arthroplasty.~   "
6951|NCT02966236|"~     This study is a double blinded randomized controlled trial evaluating the impact of~     tranexamic acid use on the transfusion rate in patients with complex kidney stones~     undergoing percutaneous nephrolithotomy.~   "
6952|NCT02966223|"~     The primary question of interest is quantifying the relationship between Y-90 liver therapy~     and liver damage. Little is known on this subject. Present assumptions and calculations of~     Y-90 administration are based on surgical lobar hepatectomies and external radiation beam~     therapies. The investigators hope that by using a functional model of the liver, the~     investigators can improve this important knowledge gap.~      The investigators will be enrolling patients planning to receive Y-90 therapy for the~     treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular~     carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical~     criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy~     of the present diagnostic model and the significant risk of biopsy and tumor seeding.~      Y-90 therapy involves administering radioactive particles to liver tumors by placing a~     catheter in a hepatic artery supplying the tumor using angiographic techniques and injection~     of these particles.~      Y-90 PET/CT imaging has been established as a method to validate and quantitate distribution~     of Yttrium after Y-90 administration. The post Y-90 therapy PET/CT images provide an imaging~     distribution of the Y-90, which is essential for validation of administered versus planned~     dose to the liver lesion and background liver.~      If the investigators can compare the Y-90 distribution to estimate background liver~     radiation distribution and dose (generated by the Y-90 PET/CT scan) combined with the global~     and regional function map (generated by the HIDA scan performed before and after therapy),~     then the investigators will be assuming that the difference pre and post therapy in global~     and regional function can be ascribed to the Y-90 administration. The investigators will~     also analyze the MRI and CT sets performed before and after therapy and correlate the~     imaging results collected with clinical findings such as ascites/encephalopathy and routine~     serological markers (bilirubin, albumin, INR, etc.). With this information, the~     investigators will have the potential to establish whether there is a relationship between~     Y-90 distribution to non-tumoral (normal) hepatic parenchyma and the incidence and severity~     of REILD. This would have the potential to improve selection criteria and outcomes in~     populations selected for Y-90 therapy in the future.~   "
6953|NCT02966197|"~     Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and~     even maternal death. Interventional radiological techniques have been developed to limit~     massive hemorrhage during caesarean section. This study investigated the efficacy of~     prophylactic internal iliac artery balloon catheterization in management for placenta previa~     and accreta.~   "
6954|NCT02966184|"~     This study is designed to compare the length of continuous albuterol administration between~     two different albuterol formulations, BAC containing albuterol versus preservative free~     albuterol.~   "
6955|NCT02966171|"~     This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in~     patients with advanced or metastatic solid malignancies who have failed or are intolerable~     to standard therapies or for whom no standard therapies exist. There are preliminary two~     stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage~     2). We will decide whether to conduct stage 2 or not one month after the last patient~     included in stage 1.~   "
6956|NCT02966158|"~     Heart disease is the number one killer amongst chronic diseases around the world, and it is~     responsible for taking the lives of an estimated 17.5 million people each year.~     Exercise-based cardiac rehabilitation (CR) programs, which help heart patients improve their~     current health, prevent future heart problems, and improve their quality of life, are an~     effective strategy for lowering the risk of heart-related deaths in heart patients. CR~     programs currently have their patients perform moderate intensity, continuous exercise~     (MICE), which traditionally takes the form of walking, jogging, or cycling at a comfortable~     pace for 30-60 minutes. Recently, aerobic interval training (AIT), which involves performing~     short bouts of exercise, typically ranging from 15 seconds to four minutes at near maximal~     effort, followed by periods of recovery or rest, has emerged as a more effective strategy~     than MICE for lowering the risk of heart-related deaths in heart patients. Although these~     initial findings appear to hold much promise for improving CR programs in the future, it is~     important to recognize that women have been underrepresented or not included in these~     studies to date. Therefore, the goal of this study is to determine the effects of AIT versus~     MICE on the risk of heart-related death, blood vessel health, and brain health in women who~     have heart disease, and who have been referred to a six-month, outpatient CR program.~   "
7001|NCT02965573|"~     This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to~     evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of~     autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.~   "
41981|NCT02506439|"~     Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant~     women.~   "
6957|NCT02966145|"~     The goal of this study is to identify the most reliable methods of analysis for tracking~     CBD, PSP, and o/vPSP over time. The results from this study may be used in the future to~     calculate statistical power for clinical drug trials. The study will also provide~     information about the relative value of novel imaging techniques for diagnosis, as well as~     the value of imaging techniques versus testing of blood, urine, and cerebrospinal fluid~     (CSF) 'biomarkers'.~   "
6958|NCT02966132|"~     The primary aim of the proposed study is to conduct a randomized controlled trial (RCT) to~     evaluate the efficacy of the Interactive Mobile Doctor (iMD) intervention targeting 150~     Chinese-, Korean- or Vietnamese-speaking male patients who smoke daily and have a scheduled~     clinic visit at Asian Health Services primary care.~   "
6959|NCT02966119|"~     RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral~     haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet~     medication) for the prevention of vaso-occlusive disease before the ICH.~      RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of~     aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a~     beneficial net reduction of all serious vascular events over two years compared with a~     policy of avoiding antiplatelet drugs.~   "
6960|NCT02966106|"~     rTMS has appeared a potential new non-invasive antidepressant method, which implies~     non-convulsive focal stimulation of the brain through a time varying magnetic field. ).~     Research on rTMS reports of minimal side effects of the method . The majority of clinically~     controlled studies have used high frequency stimulation of the left frontal cortex .~      Fewer studies have used right prefrontal, which has less side effects, such as local~     discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation~     .Both stimulus models has been shown to have statistically significant antidepressant effect~     and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex~     i associated with an antidepressant effect at the same level as the high frequency model.~     Therefore the investigators want to examine the antidepressant effect of a specific rTMS low~     frequency model in a clinical setting using a placebo controlled, randomized double blind~     design.~   "
6961|NCT02966093|"~     The primary purpose of this study is to compare the progression-free survival (PFS) of~     participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and~     radiographic evidence of disease progression within the prior 12 months treated with~     lenvatinib 24 mg by continuous once daily (QD) oral dosing versus placebo.~   "
6962|NCT02966080|"~     Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support~     called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New~     materials used in ECMO machines may help prevent clots - this could allow the use of lower~     doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to~     high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent~     clotting, but may cause less bleeding and be safer for patients.~   "
6963|NCT02966067|"~     The study will be completed as a two part, prospective, single-centre, randomised controlled~     trial.~      Five volunteers (dentists) will be recruited in the first part of the study to evaluate and~     examine the microneedle device and its use. Based on those qualitative findings (individual~     interviews and focus group) modifications to the microneedle device will be implemented~     before part two of the study commences.~      Twenty volunteers will be enrolled in the second part of the study. A split mouth design~     will be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone~     microneedles of 280µm height with a standard 30-gauge short hypodermic needle in the~     delivery of local dental anaesthetic solution. Quantitative and qualitative measurements of~     the pain experienced and the depth of anaesthesia achieved will be recorded and compared.~   "
6964|NCT02966054|"~     Epidemiologic data consistently indicate that colorectal cancer survivors can improve their~     quality-of-life and prognosis by engaging in physical activity. This study aims to build on~     this epidemiologic work and translate the findings to inform and change patient behavior.~     The specific aims are to: (1) Develop a mobile technology physical activity intervention~     among colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot~     randomized controlled trial utilizing mobile technology to increase physical activity among~     40 men and women who have completed standard cytotoxic chemotherapy for primary stage I-III~     colorectal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants~     in the intervention arm will receive a Fitbit® for self-monitoring, interactive text~     messages, and educational print materials; participants in the control arm will receive~     educational print materials at baseline and will be given a Fitbit® after completion of the~     3-mo. follow-up assessment.~   "
6965|NCT02966041|"~     To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the~     incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation~     of post-operative sedation. In patients who have undergone open heart surgery, a single~     prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol~     sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in~     the first 24 post-operative hours compared to placebo.~   "
6966|NCT02966028|"~     The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg)~     compared to placebo on the progression of absolute change in coronary artery calcium volume~     score over a 12‑month (52 weeks) period in ESRD patients on HD~   "
6967|NCT02966015|"~     The aim of the study is to investigate the navigation of a newly developed catheter.~   "
6968|NCT02966002|"~     Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop~     complications many years after their operation. Studies have shown that some of these~     patients develop an ongoing inflammatory state, which may be the cause of these late~     complications. Aspirin is a common over the counter anti-inflammatory medication used for~     many other chronic diseases. This study may help determine if aspirin therapy can limit the~     inflammation seen in Fontan patients and prevent these late complications.~   "
6969|NCT02965989|"~     This study evaluates if the implementation of an online platform with procedures and~     protocols, improve the knowledge of professionals and can have a health impact related to~     decreased contamination of blood cultures.~   "
6970|NCT02965976|"~     This randomized phase II trial studies how well botulinum toxin type A works in preventing~     complication after surgery in patients with esophageal cancer. Botulinum toxin type A may~     cause less complications of nausea and vomiting after surgery.~   "
6971|NCT02965963|"~     The purpose of this study is to examine the effect of dopamine infusion and dopamine-2~     receptor blockade on pulmonary capillary blood volume, diffusion, and the hemodynamic~     variables of pulmonary artery pressure, cardiac output, and pulmonary vascular resistance~     during exercise. Secondarily, this study will examine the effect of dopamine infusion and~     dopamine-2 receptor blockade on exercise tolerance.~   "
6972|NCT02965950|"~     This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified~     to one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs.~     TP53 wt disease, and treated with dose-dense cyclphosphamide. Furthermore, patients included~     are stratified based on tumor stage; i.e. locally advanced breast cancer (M0 disease) or~     metastatic breast cancer (M1 disease). All participating cancer centers will prospectively~     include patients with breast cancer fulfilling the inclusion criteria.~      If patients do not respond to the experimental treatment as outlined in the protocol,~     treatment with dose-dense cyclophosphamide will be terminated, and further cancer treatment~     will continue at the treating oncologist's discretion. The response data for all patients~     who have received at least one chemotherapy course will be included in the final efficacy~     analysis.~      Tumor tissue, blood samples and radiology data will be collected before therapy starts, if~     therapy needs to be changed, and for patients with locally advanced breast cancer: at~     surgery. Response data will be evaluated closely during treatment, with clinical assessment~     of tumor size every two weeks for patients with locally advanced breast cancer and by~     radiology every eight weeks for patients with metastatic breast cancer. Evaluation of side~     effects/tolerance will be performed at every clinical visit, i.e. every two weeks for all~     patients included in the p53 trial.~   "
6973|NCT02965937|"~     The study aim is to evaluate the effectiveness of Story-Centred Care Intervention Program on~     reducing depressive symptoms, improving cognitive function, HRV, Blood pressure and quality~     of life in older adults living in a long-term care facility.~   "
6974|NCT02965924|"~     Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist~     commonly used topically for dilation prior to ocular fundus examination. In the eye,~     phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting~     ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous~     pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured~     non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect~     episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of~     episcleral veins helps us in better understanding of pathophysiology of glaucoma.~   "
6975|NCT02965911|"~     The purpose of this protocol is to conduct a trial in a selected population of patients with~     PBC based on an incomplete biochemical response after 12 months of UDCA therapy.~   "
6976|NCT02965898|"~     Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology~     is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP~     patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.~      Recently, the investigators and others have found that vitamin D may protect from the~     formation of fibrosis on cellular level. The investigators hypothesized that after the first~     AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and~     designed this RCT.~      The aim is to study whether the investigators can prevent CP with vitamin D substitute.~      In this randomized controlled patient study, the patients after their first AP are~     randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of~     vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory~     tests at the baseline after recovery from AP and yearly then after.~      Primary endpoint is the development of parenchymal changes possibly related to fibrosis.~     Secondary endpoints are the development of CP with Mannheim criteria, CP related~     complications and mortality.~      The first analysis will be done after 3 years.~      The enrollment will begin 26.9.2016~   "
6977|NCT02965885|"~     A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first~     initiated in Japan in April 2014 and has been ongoing since then. The study consists of a~     dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once~     daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are~     being evaluated. This phase I study is also planned to enrol with advanced solid tumors in~     UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western~     patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC~     harbouring EGFR mutations (EGFRT790M+) or EGFR mutations (T790M-) will be further evaluated~     for safety, tolerability and efficacy in 3 separate cohorts at recommended dose of TAS-116~     on the 5 days on/2 days off regimen.~   "
6978|NCT02965872|"~     Thirty healthy individuals will be participants of the study. Participants will evaluate~     with the following assessment tools: Demographic datas; age, gender, height, body mass, will~     be recorded. Postural sway and limits of stability parameters will evaluate with~     computerized balance evaluation system (BERTEC) for seven times .~   "
6979|NCT02965859|"~     The study objective is to evaluate the safety and effectiveness of different doses of~     Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an~     appropriate clinical dosage by comparing the effect of different doses of treatment,in order~     to provide references of clinical trial of the next phase.~   "
6980|NCT02965846|"~     The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1%~     AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry~     eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice~     daily in patients with EDE~   "
6981|NCT02965833|"~     The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE®~     multipurpose contact lens solutions in presbyopes currently wearing soft contact lenses and~     experiencing symptoms of dryness.~   "
6982|NCT02965820|"~     The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to~     non-HYDRAGLYDE® multipurpose contact lens solutions in presbyopes currently wearing soft~     contact lenses and experiencing symptoms of dryness.~   "
6983|NCT02965807|"~     This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate~     bronchial asthma in China, by observing the improvement of quality of life, the decrease of~     acute attack and emergence, as well as the incidence of related complications.~   "
6985|NCT02965781|"~     This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes~     labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the~     other third will receive only the vehicle as a placebo control. The solutions will be~     administered topically to the patient's arms. The study will compare a single-arm~     application versus a two-arm application versus two placebo doses on the arm.~   "
6986|NCT02965768|"~     The main objective of this study is to test if naltrexone, when taken in low doses, has an~     anti-inflammatory effect that may be associated with positive clinical outcomes in people~     with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior~     work in which we showed that chronic fatigue symptoms are associated with immune activity,~     and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is~     thought to share some pathophysiological and clinical characteristics with CFS.~   "
6987|NCT02965755|"~     The goal of this research study is to determine if we can obtain personalized genetic~     information from a subject's blood sample that is similar to that obtained from a tumor~     tissue sample, and if we can use that information to make treatment suggestions.~   "
6988|NCT02965742|"~     The main objective of this study is to assess the concordance of body composition measures~     between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and~     the Hologic QDR 4500 A by Hologic inc.~   "
6989|NCT02965729|"~     The purpose of the study was to examine the influence of step goals with pedometers to~     improve children's weight loss, physical activity, and psychosocial health during behavioral~     treatment. Children with overweight or obesity were assigned to receive the behavioral~     treatment alone, plus pedometers, or plus pedometers with step goals.~   "
6990|NCT02965716|"~     This phase II trial studies how well talimogene laherparepvec and pembrolizumab work in~     treating patients with stage III-IV melanoma. Biological therapies, such as talimogene~     laherparepvec, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop tumor cells from growing. Monoclonal antibodies,~     such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.~     Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with~     melanoma by shrinking the tumor.~   "
6991|NCT02965703|"~     This randomized phase IIa trial studies how well aspirin works in preventing colorectal~     cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
6992|NCT02965690|"~     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.~     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant~     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of~     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have~     been developed to solve the problem. However, most of their designs are based on~     experimental data and little has been studied about their kinematics in vivo. In this study,~     we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere)~     implant and compare it with a well documented design and implant (Nexgen Cruciate Retaining~     (CR), Zimmer Biomet). We assume our study will contribute the development of more satisfying~     knee implants.~   "
6993|NCT02965677|"~     To evaluate the safety and efficacy of the paclitaxel eluting balloon dilatation catheter~     (LEGFLOW OTW) compared with the standard balloon (Admiral Xtreme) for the treatment of~     stenosis or occlusions in femoral popliteal artery.~   "
6994|NCT02965664|"~     A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops in Presbyopic~     Subjects.~   "
6995|NCT02965651|"~     The purpose of this randomized controlled trial is to evaluate the feasibility of~     introducing an innovative eHealth technology, the Embodied Conversational Agent (ECA), to~     diverse women from an urban outpatient setting.~   "
6996|NCT02965638|"~     The purpose of this study is to determine if maternal hyperoxygenation is an effective~     treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined~     by measuring how well a baby's heart valves and their surrounding tissue are growing and~     functioning.~      In addition the investigators will examine brain growth using fetal ultrasound and MRI, and~     MRI of the child's brain after they are born to determine if there is greater neonatal brain~     maturity or mothers receiving oxygen compared to fetuses of mothers receiving placebo.~   "
6997|NCT02965625|"~     Human epicardial fat is the true visceral fat depot of the heart, and its regional~     distribution and physiology is of growing scientific and clinical interest. This study aims~     to characterize the expression profile and function of the epicardial and pericardial~     adipose tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be~     obtained from patients undergoing coronary artery bypass graft surgery (CABG) or valve~     replacement surgery.~   "
6998|NCT02965612|"~     The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive~     potential role that could be played, in particular in the forms of allergic asthma, because~     this method constitute the only intervention (unlike that pharmacologic) able to act on the~     same causes of the disease, altering the natural history. To achieve this the investigator~     has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies~     that, with scientific rigor, have demonstrated the benefits.~   "
6999|NCT02965599|"~     GSK3117391 has the potential to complement existing therapies in the treatment of chronic~     inflammatory disorders such as rheumatoid arthritis (RA). This study will evaluate the~     efficacy, safety and tolerability of oral GSK3117391 (Dose A) administered to subjects with~     severe RA despite treatment with disease-modifying anti-rheumatic drugs (DMARDs). This is a~     randomised, double-blind (sponsor open), multicentre, placebo-controlled, parallel group~     study. The total maximum study duration is approximately 10 weeks. Following a screening~     period of up to 28 days, subjects will be randomized (1:1) to placebo or GSK3117391 (Dose A)~     administered orally for a period of 28 days. Subjects will be followed up for 7 to 14 days~     post final dose. Approximately 40 subjects with severe RA will be randomised into the study.~   "
7000|NCT02965586|"~     compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and~     prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.~   "
7017|NCT02965365|"~     This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can~     be predicted via evaluating pulmonary artery Doppler indices.~   "
7002|NCT02965560|"~     Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan~     failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to~     infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could~     subdue systemic inflammation and alleviate liver injury in mice model. However, there are no~     studies evaluating PGE2 as a predictor of early mortality.This study is designed to~     investigate whether plasma PGE2 and its receptors are associated with development of MOF and~     predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we~     will also measure several other potential predictive factors (C-reactive protein,severe~     hyponatremia, Second infections,Diabetes mellitus,High density~     lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte~     ratio,urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).~   "
7003|NCT02965547|"~     The purpose of this study is to determine the impact of remote ischemic preconditioning on~     dynamic cerebral autoregulation and related hematology indexes in healthy adults.~   "
7004|NCT02965534|"~     Reduced quality of vision and glare in twilight or night are frequently mentioned complaints~     within the optometric examination. A reason for these problems could be a myopic refractive~     shift in dark light conditions, commonly known as night myopia or twilight myopia.~      The aim of this study was to investigate whether quality of vision in twilight or night~     could be improved by a spectacle correction optimized for mesopic light conditions.~     Moreover, objective refraction in large pupils measured by aberrometry was compared to~     subjective mesopic refraction.~   "
7005|NCT02965521|"~     Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal~     cancer increases risk of disease recurrence and death. High intake of red and processed~     meat, dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'.~     This study aims to translate the epidemiologic findings into a patient-centered, web-based~     dietary intervention with text messaging to inform and modify users' dietary choices. The~     investigators' specific aims are to: 1) Develop a web-based dietary intervention with text~     messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized~     controlled trial to determine the acceptability and feasibility of the dietary intervention~     among 50 colorectal cancer survivors. All participants will receive standard of care print~     materials regarding diet following a colorectal cancer diagnosis. Participants in the~     intervention group will also receive access to a web-based dietary intervention with text~     messaging for 12 weeks. This study will generate preliminary data on the effect of the~     intervention on dietary choices among colorectal cancer survivors for future studies.~   "
7006|NCT02965508|"~     The objective of this pragmatic randomized controlled trial is to compare the impact of~     physician directed home-based primary care with office-based primary care on~     hospitalizations, symptom control, caregiver burden, healthcare costs and other outcomes for~     older homebound adults and to conduct a dissemination and implementation evaluation to~     support future home-based primary care adoption~   "
7007|NCT02965495|"~     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa~     clinical trial of YYD302 for treatment of osteoarthritis of the knee.~   "
7008|NCT02965482|"~     The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating~     mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the~     Wright jet nebulizer) for methacholine challenge testing. The results will then give an~     indication as to whether the novel technique accurately assesses a given dose of~     methacholine with the new Aerogen Solo device. In addition, the reproducibility of test~     results with each method will be examined. Altogether, the findings from this investigation~     may provide means for better standardization of current testing guidelines.~   "
7009|NCT02965469|"~     This study will begin to assess the association between perceived stress and enhanced aging~     in persons living with HIV (PLWH). The investigators suspect this relationship may be~     mediated by increased aging within the immune system and subsequent low-level inflammation~     that commonly leads to multiple illnesses and frailty as one ages. The findings from this~     study will identify potential diagnostic and therapeutic targets to improve the health of~     aging PLWH which could also apply to HIV-uninfected populations.~   "
7010|NCT02965456|"~     Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne~     Vulgaris~   "
7011|NCT02965443|"~     To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor~     dapagliflozin + the DPP-4 inhibitor saxagliptin vs placebo to revert from a BBIT regimen to~     a BOT regimen in patients with type 2 diabetes.~   "
7012|NCT02965430|"~     This is an open-label, comparative, and prospective pivotal study to demonstrate that~     AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic~     fluid leakage rather than by urinary incontinence.~      Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice~     any wetness.~      The blinded physician will perform a diagnosis according to the standard diagnostic methods~     (clinical assessment). The standard diagnostic methods will include the following tests: (1)~     Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive~     result in both the pH test and the Ferning test is defined as a positive clinical~     assessment.~   "
7013|NCT02965417|"~     This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic~     colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor~     (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR~     (ECD-EGFR).~   "
7014|NCT02965404|"~     The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine~     in healthy adults, adolescents, and children.~   "
7015|NCT02965391|"~     Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden.~     Circulating tumor DNA levels should decrease after complete surgery and could be increase as~     tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung~     cancer patients that no criterion has been established of how to use it for surveillance.~   "
7016|NCT02965378|"~     This phase II trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating~     patients with stage IV squamous cell lung cancer that has come back after previous~     treatment. This is a sub-study that includes all screened patients positive for the~     fibroblast growth factor receptor (FGFR) biomarker. FGFR can cause tumor cells to grow more~     quickly. AZD4547 may decrease the activity of FGFR and may be able to shrink tumors.~   "
7019|NCT02965339|"~     Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension,~     atherosclerosis, dyslipidemia, chronic renal failure ...).~      It is likely that a significant number of patients suffering from a preexisting endothelial~     dysfunction. This endothelial dysfunction can be assessed by a molecular approach~     (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal~     circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx~     as ischemia-reperfusion injury is. No studies have evaluated the time course of the~     infringement, and its association with the immediate post-operative complications (SIRS,~     coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an~     association between endothelial dysfunction during cardiac bypass surgery and postoperative~     cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an~     association between endothelial dysfunction (assessed by a vasoplegia test) and~     postoperative acute renal failure. Thus there is some data in the literature to suggest that~     the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome,~     acute circulatory failure vasoplegic and acute renal failure) may result from the~     interaction between a pre-existing endothelial dysfunction and operative aggression~     (extracorporeal circulation). The onset of complications result from an interaction that~     depends on the importance of endothelial dysfunction at baseline.~   "
7020|NCT02965326|"~     The purpose of this study is to determine which biological marker, or association of~     biological markers, best predict clinical response of cystic fibrosis patients to CFTR~     modulators.~   "
7021|NCT02965313|"~     This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative~     vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal~     surgery is preferred as minimally invasive, however the investigators do not know if~     materials such as synthetic polypropylene mesh improve success, durability and~     cost-effectiveness long-term. The investigators principal goal is to compare the~     experimental bilateral sacrospinous vaginal vault fixation with synthetic mesh arms~     (BSSVF-M) to the current standard of sacrospinous ligament suspension with synthetic sutures~     (SSLS) over a timeline of 2 years. Patients and evaluators will be blind to technique.~   "
7022|NCT02965300|"~     The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath~     of pulmonary lesion patients and healthy controls, in order to find the difference of~     composition and concentration among groups.~   "
7023|NCT02965287|"~     The investigators have developed a diagnostic test for the evaluation of the presence of~     fetal malformations through metabolomic analysis of maternal peripheral blood serum by~     chromatographic techniques and mass spectrometry, and subsequent mathematical modeling~     analysis of the data by means of multivariate mathematical models specifically developed for~     this purpose. The study aims at determining the performance parameters (specificity,~     sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the~     test and its applicability. To do this, the investigators will use the serum samples of the~     patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international~     study conducted between years 2004-2008.~   "
7024|NCT02965274|"~     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg~     and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were~     separated by a washout period of 35 days.~   "
7025|NCT02965261|"~     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg~     and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were~     separated by a washout period of 35 days.~   "
7026|NCT02965248|"~     This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic~     intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in~     locally advanced colorectal cancer~   "
7027|NCT02965235|"~     Postoperative cognitive dysfunction (POCD) is a subtle cognitive dysfunction, especially~     postoperative memory impairment lasting for weeks or months. The underlying~     pathophysiological mechanism of POCD remain unclear. The aim of this study is to explore the~     epigenetic changes during perioperative period and its correlation with POCD in surgical~     patients.~   "
7028|NCT02965222|"~     To establish embryo time-difference kinetics scoring model for embryo selection before~     embryo transfer. It is especially suitable for selective single embryo transfer, advanced~     infertile women, and patients with repeated transplant failure. It can effectively improve~     clinical pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce~     the risk of multiple pregnancies.~   "
7029|NCT02965209|"~     The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which~     offers all of the advantageous options of spiral enteroscopy with a faster and less invasive~     approach. The system is similar to other currently marketed endoscopes in that it~     incorporates a flexible insertion tube, light source, digital imaging, and channels for~     passing accessories for sample collection or therapeutic interventions. The NMSE system is~     unique in that it incorporates a user-controlled motor contained in the endoscope's handle~     to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff,~     which has soft spiral-shaped fins, pleats the small bowel on to the endoscope's insertion~     tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system~     also includes a display monitor, a motor control unit, device to display measured motor~     current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope~     and limitation of rotation to a short cuff instead of a long overtube promise to accelerate~     the procedure, to facilitate insertion and to improve maneuvering the instrument in~     comparison to conventional spiral enteroscopy~   "
7030|NCT02965196|"~     The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an~     adjunct to analgesics.~   "
7031|NCT02965183|"~     Examination of the correlation between adenoid hypertrophy and body temperature in candidate~     children for adenoidectomy after exercise~   "
7032|NCT02965170|"~     Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels~     (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of~     this newly developed test will be compared to Tysabri® serum levels measured in parallel~     using an independent test. We will also simultaneously measure a pharmacodynamic marker of~     Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate~     with Tysabri® serum levels.~   "
7033|NCT02965157|"~     Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and~     efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting~     antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28.~     Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector.~     Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After~     T cell infusion, the patients will be evaluated for 24 months for adverse reactions,~     persistence of CAR T cells and efficacy.~   "
7034|NCT02965144|"~     This study builds on the limited body of existing literature combined with the results from~     the investigators' previous research conducted with 30 newly diagnosed patients with~     high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of~     the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of~     needs and preferences from time of diagnosis to one year exist. However, such data are still~     lacking the representation from long-term survivors (LTS) and their caregivers.~      This mixed methods study aims to address perspectives on daily life experiences of long-term~     survivors with HGG and their caregivers as well as the needs and preferences for support,~     rehabilitation and palliation.~      Separate telephone interviews with patients and their caregivers and self-reported~     questionnaires for patients will be conducted. The mixed methods design is a convergent~     sequential design using an identical sampling.~   "
7035|NCT02965131|"~     This study aims to investigate the effects of the anhepatic phase extended by temporary~     portocaval shunt on the sensitivity to desflurane administered at 0.6 age-adjusted minimum~     alveolar concentration and its associative postoperative cognitive function.~   "
7036|NCT02965118|"~     This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in~     Atopic Dermatitis patients.~   "
7037|NCT02965105|"~     The aim of the study is to test the performance and safety of a newly developed intermittent~     catheter~   "
7038|NCT02965092|"~     Chimeric antigen receptor (CAR) consists of single chain variable fragment (scFv) and~     activation domain of T cell, and CAR-modified T cells (CAR-T cells) have the capabilities to~     recognize tumor associated antigen and kill tumor cells specifically. To a large part of~     patients with refractory or relapsed B cell malignancies, CAR-T cell adoptive immunotherapy~     can play a revolutionary effect in the field of cancer treatment. The investigators believe~     that the cells with CD137 will have a better chance of killing the leukemia cells. In the~     lab, the investigators constructed a second generation CAR containing CD137. The~     investigators start Phase I study aimed to relapsed or refractory B cell malignancies. The~     purpose of this study is to evaluate the safety and effectiveness of CD19 CAR-T cells in~     patients.~   "
7039|NCT02965079|"~     Investigators will aim to conduct an observational study in order to assess very thoroughly~     all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care~     units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).~      Secondary objectives will be:~        1. to assess efficacy and safety of ECCO2R,~        2. to compare the data issue from the registry to others studies assessing the same~          population and to other centers and~        3. to compare the different ECCOR devices in terms of efficacy and adverse events.~   "
7040|NCT02965066|"~     The aim of the study is to test the performance and safety of a newly developed intermittent~     catheter in healthy volunteers.~   "
7041|NCT02965053|"~     This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and~     Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy~     of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving~     hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are~     identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789~     and its combination with sevelamer carbonate are tested in Period 1 and Period 2~     respectively.~   "
7042|NCT02965040|"~     For subjects with normal renal function or severely impaired renal function, this study will~     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.~      For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal~     dialysis (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the~     pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate.~      For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will~     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and~     dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main~     metabolites.~   "
7043|NCT02965027|"~     Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been~     called the signature injury of soldiers who served in the Iraq and Afghanistan conflicts.~     mTBI can also occur from impact or hitting the head on an object or the ground. Although~     termed mild in comparison to major brain injuries, people with mTBI can have problems with~     their memory and concentration. People with mTBI can also find they are more irritable, have~     more anxiety, and have trouble with their mood and sleep.~      The purpose of this study is to see if a medication called prazosin can help treat chronic~     headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin~     for treating people with high blood pressure. At this time, the FDA has not approved~     prazosin in the treatment of mTBI or headaches. Some people who have posttraumatic stress~     disorder (PTSD) and have been taking prazosin for their medical conditions or who have taken~     it in research studies have said they have fewer headaches.~   "
7044|NCT02965014|"~     This three-arm cluster randomized trial will develop, test, and compare the efficacy of two~     delivery formats of the Women's CoOp (WC), which is designed to provide risk reduction and~     empowerment skills, as well as linkages to healthcare services for substance-using women.~     The current study will develop a revised version of the WC and evaluate the relative~     efficacy of a face-to-face (face-to-face WC), mobile Health application (mHealth WC)~     delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual~     behaviors, reduce substance use, and increase linkages to care among young (18-25 years)~     substance - using African American women who are sexually active and have not recently been~     tested for HIV in three NC counties.~   "
7284|NCT02961868|"~     PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions.~     This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier:~     NCT02884141), which aims to document phenotypic and genetic traits in patients with renal~     and/or cervical artery fibromuscular dysplasia.~   "
7045|NCT02965001|"~     Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade,~     there has been made substantial improvements in diagnosis, staging and treatment of HNC. The~     overall survival has improved, but for some subgroups it is unchanged and therefore new~     prognostic and surveillance methods are warranted.~      One of the hallmarks in cancer is the ability to invade the surrounding tissue and~     metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA)~     and its receptor (uPAR) are present at the very front of the invasive tumor and they are~     considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted~     tracer offers a very promising target for functional PET imaging and may be a stronger~     prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT~     correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the~     pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this~     project all participants have an uPAR-PET/CT scan performed before initiation of the routine~     radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate~     and mortality at routine clinical follow-up.~   "
7046|NCT02964988|"~     The purpose of this study is to investigate the applicability of urokinase plasminogen~     activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in~     patients with metastatic castration-resistant prostate cancer (mCRPC)~   "
7047|NCT02964975|"~     Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic~     Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant~     reduction in short-term and long-term mortality. To our knowledge till today no prospective~     randomized trial compared percutaneous revascularization of CTO with optimal medical~     therapy. For this reason quality of live improvement is one of the most important~     indications for revascularization in elective patients with CTO. In contemporary literature~     Seattle Angina Questionnaire (SAQ) is a psychometrically solid disease-specific instrument~     designed to assess the functional status of patients with angina. It comprises 19 questions~     that quantify five clinically relevant domains: physical limitation, angina stability,~     angina frequency, treatment satisfaction and disease perception/quality of life.~      In this open prospective study patients with CTO of coronary artery will be randomized in~     two groups: first - patients with percutaneous coronary intervention of chronic total~     occlusion with optimal medical therapy and second group - patients with only optimal medical~     therapy (control group). Primary endpoint will be quality of life and secondary endpoints~     will be mayor adverse cardiovascular events (MACE). All patients will complete Seattle~     Angina Questionnaire before randomization and after 6 months of follow-up.~   "
7048|NCT02964962|"~     The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of~     the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in~     symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     extreme or high risk for surgical aortic valve replacement (SAVR).~   "
7049|NCT02964949|"~     Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically~     and irregularly, out of coordination with the two lower chambers (called ventricles) of the~     heart. This can lead to blood clots forming in the heart chamber.~      Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for~     up to 12 months, with a 2-4 week follow-up, after which their participation is complete.~      Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30,~     90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).~   "
7050|NCT02964936|"~     The objective of this study is to evaluate the efficacy and the safety when ASP1517 is~     intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis~     chronic kidney disease patients with anemia.~   "
7051|NCT02964923|"~     The purpose of the study is to investigate these effects of Second-Generation Antipsychotic~     (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore~     the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous~     Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic~     disorder in Chinese Han persons with schizophrenia who are taking one of the~     SGAs(olanzapine, risperidone or ziprasidone).~   "
7052|NCT02964910|"~     This phase IV clinical study was designed to evaluate the immunogenicity and safety of the~     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,~     in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age~     at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered~     intramuscularly according to a 0-1-6 month schedule.~   "
7053|NCT02964897|"~     Veterans leaving incarceration and re-entering their communities (often described as~     reentry Veterans) face a number of challenges, including uncertainty about housing,~     vulnerability to substance use and relapse, on-going mental health concerns, and often~     multiple health conditions require timely continuity of care. The purpose of the project is~     to increase support for Veterans post-incarceration through the addition of trained peers~     with lived experience of being a Veteran and a history of incarceration. Emphasis will be on~     peers who will help link Veterans to Veterans Health Administration (VHA) services,~     including housing and healthcare. Peers will provide linkage with Health Care Reentry~     Veterans program specialists, transportation to appointments, and support in community~     reintegration. Peers will assist reentry veterans to make a successful transition and get~     and stay engaged in their care.~   "
7054|NCT02964884|"~     Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four~     times greater risk of learning disabilities, including reading disabilities, and a~     deficiency of neurofibromin - a protein important in a signaling pathway that regulates~     learning and memory. Our previous work (NS49096) demonstrated that school-age children with~     NF+RD can respond to standard phonologically-based reading tutoring originally developed to~     treat reading disability in the general population. Combining our work with that by other~     researchers suggesting that a medication (Lovastatin) may counteract the effects of the~     deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the~     investigator propose to examine the synergistic effects of medication plus reading tutoring.~   "
7285|NCT02961855|"~     Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of~     CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac,~     referred as treatment B) in benign anorectal surgery.~   "
7055|NCT02964871|"~     RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of~     a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless~     transmission of results, and provision of infection control guidance when influenza is~     detected. Because of the nature of the intervention, blinding is not possible. Sites will be~     initially recruited for a study of respiratory infections within LTCFs. After acceptance~     into the study, sites will be matched in terms of bed capacity, location, and other features~     prior to randomization.~   "
7056|NCT02964858|"~     The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25~     fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36~     Gy in 20 fractions.~      The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing~     improvement in overall survival and progression free survival with combined modality~     treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55~     Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive~     lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of~     higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid~     abnormalities and secondary breast cancer are being increasingly identified. Hence it is~     essential to optimize the dose of radiotherapy for lower toxicity without compromising on~     efficacy.~   "
7057|NCT02964845|"~     Women recently released (RR women) from incarceration constitute a vulnerable group~     characterized by high rates of untreated HIV and sexually transmitted infections (STIs),~     substance use disorder (SUD), mental health (MH) disorders and trauma. This interconnected~     syndemic requires helping RR women to overcome multiple internal and structural care~     barriers. This R34 builds on work conducted by the PI in a NIDA-funded K23 project, in which~     an intervention called Women's Initiative Supporting Health (WISH) was developed to improve~     RR women's engagement in HIV, Hepatitis C (HCV), and primary medical care using Self~     Determination Theory (SDT). The proposed R34 project, a natural extension of this prior~     work, will conduct a pilot randomized controlled trial (RCT) of the WISH intervention to~     examine feasibility, acceptability, and preliminary effectiveness.~   "
7058|NCT02964832|"~     To improve the quality of CPR education, we want to assess the validity and reliability of~     the feedback depth measured by smartphone applications according to the smartphone~     attachment sites as an educational tool. However, in the prior study, armband method showed~     overestimated chest compression depth. The reason of the overestimation was analyzed that~     the weight of the smartphone amplified the inertial force to produce additional linear~     movement. In this study, we will make new device to fix the smartphone on the arm and on the~     hand and compare the chest compression depth between CPR manikin and smartphone application.~   "
7059|NCT02964819|"~     This project will analyze the influence of interferential current therapy in an exercise~     program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers~     of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with~     more than 3 months duration, at least grade 4 pain by the numerical scale of pain~     assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be~     randomized into the following groups: exercise group, exercise + ultrasound group, exercise~     group + interferential current. Sixteen consecutive treatment sessions will be performed,~     and the volunteers will be evaluated before and after, by means of the following~     instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index~     (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of~     evaluation of pain at the end of Each session and one month after the end of treatment.~   "
7060|NCT02964806|"~     Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary~     surgery contribute impaired nutritional status in postoperative period. It can also affect~     perioperative and oncologic outcomes negatively. Therefore it is important to improve~     nutritional status in postoperative period by supply tailor-made optimal diets. The~     investigators have developed customized postoperative diets for pancreaticobiliary cancer~     patients. The investigators expect that customized diets for pancreaticobiliary patients~     will increase the food intake rate and contribute a improvement of perioperative outcomes~     and even oncologic outcomes.~   "
7061|NCT02964793|"~     Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and~     policy makers, and a central question is how to improve the performance of screening during~     pregnancy in order to provide appropriate care. The recent recommendations and reporting of~     French results have raised awareness of the need to improve growth screening in France.~     Based on the existing literature, the hypothesis is that a greater investment in growth~     monitoring based on a more rigorous interpretation of information available from routinely~     implemented clinical assessment and ultrasound will allow for significant gains in~     detection. The current context provides the opportunity to evaluate the application of a~     training program for serial plotting of Symphysis Fundal Height (SFH) and Estimated Fetal~     Weight (EFW) on customised charts. This intervention is consistent with French guidelines~     which support the monthly measurement of SFH, the use of Customised Fetal Weight Reference~     (CFWR), in particular for referral US (Ultrasound) examinations, and the longitudinal~     interpretation of growth. These guidelines were recently restated in the clinical practice~     recommendations issued by the French College of Obstetricians and Gynecologists.~      The intervention tested in the trial will include training of professionals for~     standardization of SFH measurement, introduction of software, and recommendations for growth~     interpretation and referral examinations. Expected benefits are an increase in antenatal~     identification of growth restricted fetuses without an increase in the FP rate. Such a~     program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate~     antenatal care. This intervention could double the detection rate of SGA births from 20 to~     40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be~     improved.~      Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on~     customised percentile charts supported by provider training, versus standard antenatal care,~     to improve the detection of FGR. The aim of the investigators is to double rates of~     antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the~     10th percentile for GA.~   "
7062|NCT02964780|"~     The main objective of the study is to gain insight in the early dynamics and mechanisms of~     recovery of liver disease and sex steroid metabolism during weight loss in obese men and~     women and to investigate whether surgical weight loss has differential effects as compared~     to weight loss with life style measures. In addition, we want to evaluate the postprandial~     hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.~      Secondary objectives are investigating determinants for the changes in sex steroids, liver~     disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion~     patterns, body composition, resting metabolism rate, weight loss per se and changes in fat~     distribution, parameters of fatty acid metabolism, … .~   "
7063|NCT02964767|"~     A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients~     of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A~     comparative study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co~     infected patient and HIV patients would be taken in account.~   "
7065|NCT02964741|"~     This study investigates whether non-invasive brain stimulation, given for 20 minutes/once~     per day for ten days (M-F) can reduce migraine pain. Thirty patients will receive this~     treatment, while thirty will receive a sham procedure. Up to thirty healthy volunteers~     will be asked to undergo baseline assessments only (imaging, but no brain stimulation).~     Healthy volunteer data may be used from a prior study (NINDS-K23062946 project [IRBMED~     #HUM00027383; Dr. Alexandre DaSilva, Principal Investigator]).~   "
7066|NCT02964728|"~     The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4~     patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds~     of the tongue and the lower lip for at least 6 months, refractory to common pharmacological~     treatments. Pain severity will be measured by the visual analog scale (VAS) indicating~     average week pain before injection. Each patient will be injected with a total dose of 16~     units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and~     4 units into each antero-lateral side of the tongue. In order to determine if a placebo~     effect may be involved, we will inject 2 additional patients with saline solution using the~     same volumes and the same injection sites. Patients will be evaluated at 48 hours and then~     at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be~     treated after 4 weeks with incobotulinumA with the same dose reported above.~   "
7067|NCT02964715|"~     Non-Alcoholic Fatty Liver Disease( NAFLD) is common in patients with type 2 diabetes.~     Empagliflozin, an FDA-approved oral medication used to treat type 2 diabetes, has been shown~     to reduce production and deposition of fat in the liver in animal experiments. There is~     little published evidence that this is so in Asian patients with type 2 diabetes. The~     investigators designed this pilot study to determine if use of empagliflozin for 6 months in~     patients with type 2 diabetes can improve scan, blood marker and biopsy features of NAFLD.~   "
7068|NCT02964702|"~     To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by~     removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction~     (within 8 hours after onset), in whom intravenous administration of tissue plasminogen~     activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA~     administration.~   "
7069|NCT02964689|"~     The aim is to determine the recommended phase 2 dose (RP2D) of binimetinib in combination~     with pemetrexed and cisplatin, and to demonstrate that the combination is feasible and has~     preliminary activity in previously untreated patients with advanced NSCLC and documented~     KRAS mutations.~   "
7070|NCT02964676|"~     To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number~     of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in~     Chinese PACG .~   "
7071|NCT02964663|"~     The purpose of this study was to compare CO measured by two easy to use non-invasive~     monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences,~     Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.~   "
7072|NCT02964650|"~     The investigators have demonstrated that they can reliably identify an optimum heart rate~     range for contractility of the left ventricle in patients with chronic heart failure (CHF).~     They have also demonstrated in an acute cross-over study that keeping the heart rate in this~     range (versus standard rate-response programming) in patients with CHF is associated with~     increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a~     randomised, placebo-controlled trial whether optimal programming versus standard~     rate-response programming for 6 months leads to appreciable improvements in exercise time~     and quality of life, while having no adverse effects on left ventricular function and~     battery longevity.~      60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic~     assessment to establish the force frequency relationship and the optimal heart rate for~     contractility. They will then perform a treadmill walk test and fill out a quality of life~     questionnaire. They will then be randomised to optimal rate-response settings or standard~     rate response settings and followed up at 6 months at which point the tests will be~     repeated.~   "
7073|NCT02964637|"~     To establish diagnostic tools to make an accurate clinical and pathological diagnosis of~     patients with clinical FTLD syndromes~   "
7074|NCT02964624|"~     Osteoarthritis (OA) is the most common type of degenerative joint disease. Furthermore,~     despite its incidence being amongst the highest in chronic diseases, effective biomarkers,~     diagnostic aids and imaging technology are not available to assist in the management of OA.~     Mounting evidence suggests that non-pharmacological treatment such as exercise/physical~     therapy may lower the risk for onset or progression of OA by mitigating inflammation.~     However, the mechanical unloading and overloading, as seen in disuse and overuse, lead to~     upregulation of several proinflammatory molecules and enhance tissue degradation, whereas,~     dynamic moderate mechanical loading exerts anti-inflammatory and anti-catabolic effects on~     articular cartilage by suppressing mediators of inflammation. However, the lack of robust~     biomarkers to measure the effectiveness of physical therapies, represent a critical gap in~     biotechnology, obliterating the progress in the optimal application of these therapies. Our~     central hypothesis is that the circulating levels of specific molecules could serve as~     robust biomarkers for quantitative measures of OA burden, prognosis, progression or~     treatment efficacy. The objective of this project is to identify and evaluate mediators that~     serve as biomarkers of OA progression and treatment. Recently, high mobility group box~     chromosomal protein 1 (HMGB-1) has been suggested to be markedly upregulated in OA. However,~     presently there are no inhibitors of HMGB1 that could be used therapeutically. Previous~     results showed that that gentle exercise is the only tool that can mitigate HMGB1 production~     by local and systemic macrophages, and thus inflammation. Serum concentration of HMGB1 will~     be evaluate as a biomarker in OA patients and relate it to the functional capacity of knee~     joints in OA patients after rehabilitation protocol (RP). The RP will consist of three~     rehabilitation session/week during eight weeks. The efficacy of a RP will be evaluated by~     functional scale Western Ontario & McMaster Universities Osteoarthritis (WOMAC), Scale for~     the measurement of health related quality of life using EuroQol five dimensions~     questionnaire (EuroQOL-5D), Visual Analog Scale (VAS), and physical function tests. Besides~     all clinical assessment, serum levels of classical pro-inflammatory cytokines, hyaluronan~     and HMGB1 will be evaluated. A correlation of physical improvement after RP and serum~     biomarkers will be performed.~   "
7075|NCT02964611|"~     The aim of this study is to compare personality and social cognition changes, including~     emotion detection and self-awareness, and neuroanatomical correlates in patients, and how~     that affects the caregiver-patient relationship.~   "
7088|NCT02964442|"~     Brown adipose tissue (BAT) thermogenesis can be assessed by IR thermography, the~     accompanying increase metabolic rate can be measured by whole body calorimetry and BAT~     volume can be precisely measured by MRI. The aim of the study is to validate IRT for BAT~     thermogenesis against the present gold standard 18-FDG-PET scan, quantify BAT volume by fat~     fraction MRI and measure the accompanying increase in BMR by whole body calorimetry among~     healthy euthyroid subjects.~   "
22682|NCT02760264|"~     The purpose of this study is to determine whether a new medication called vamorolone is safe~     and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and < 7 years~     old.~   "
7076|NCT02964598|"~     Adolescence associates with alterations in sleep-wake organization, such as later circadian~     phase preference. Simultaneously external pressures, such as evening-driven social~     activities increase. These may lead to delayed sleep phase, which may cause serious problems~     for waking up at socially accepted times, and absenteeism from the school may follow. This~     project aims at tracking risk factors for later circadian regulation problems,~     characterizing interconnections of biological, psychological and behavioural mechanisms that~     maintain or induce poor sleep regulation in adolescence, and building a cost-effective,~     theoretically-based sleep intervention for adolescents with delayed sleep phase. This~     randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.~   "
7077|NCT02964585|"~     The investigators hypothesize that Cana may be able to improve number and function of CD34+~     endothelial progenitor cells. The investigators also propose that this expected~     cardiovascular benefit is independent of HbA1C reduction.~      In this proposed study the investigators plan to recruit patients with type 2 diabetes of~     less than or equal to 15 years duration (in early phase of diagnosis), who are on a stable~     dose of metformin for at least 3 months but still remain inadequately controlled with HbA1C~     between 7% and 10% (both values inclusive), but not overtly out of control (> 10% of HbA1C).~      Subjects will begin taking 100 mg of Cana or placebo after initial 4 weeks. Subjects will be~     withdrawn from the study if the medication or placebo is not tolerated.~   "
7078|NCT02964572|"~     -  Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,~          interventional, exploratory pilot~        -  Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic~          control with metformin-based oral hypoglycemic agents will be prescribed glimepiride~          (comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days)~          as add-on therapy~        -  Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3~          inflammasome activity from baseline to final timepoint will be assessed.~   "
7079|NCT02964559|"~     This phase II trial studies how well pembrolizumab works in treating patients with skin~     cancer that has spread from where it started to nearby tissue, lymph nodes, or other parts~     of the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
7080|NCT02964546|"~     Atrial fibrillation in the elderly is a complex condition due to the high number of~     frequently associated comorbidities such kidney disease. Direct oral anticoagulants~     (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events~     but renal function should be closely monitored for this age group when these drugs are used.~     Dosing recommendations for prevention of stroke are based on renal clearance of creatinine~     (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates~     predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR)~     estimates. This raises the possibility that substitution of commonly reported GFR for~     estimated CrCl could result in different plasmatic concentrations of oral direct~     anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine~     the impact on the plasmatic concentration of these drugs in elderly patients with~     non-valvular atrial fibrillation.~   "
7081|NCT02964533|"~     Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire~     moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect~     and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a~     randomized controlled trial by recruiting chronic fatigue syndrome patient as subject,~     applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick~     moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as~     evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there~     are totally 15 sessions.~   "
7082|NCT02964520|"~     This study evaluates if individuals with moderate to high trait anxiety can learn how to~     self-regulate their brain waves and reduce their trait anxiety in ten sessions of EEG~     alpha-theta neurofeedback training. Half of the randomly assigned participants will receive~     alpha/theta neurofeedback training while the other half will receive a two-part control~     protocol where low beta and beta waves will be uptrained in and downtrained in in successive~     sessions.~   "
7083|NCT02964507|"~     This is a combination Phase I and Phase II study, with an aim to evaluate the combination of~     GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have~     disease that has progressed after prior treatment with at least one line of endocrine~     therapy.~      The objectives of the study are to first identify, in open-label single-arm Phase I, a~     recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I~     will follow a modified toxicity probability interval (mTPI) design, and a sentinel group~     will be evaluated first for dose-limiting toxicity and further expanded to collect~     additional safety data. This will be followed by a double-blind, randomized controlled Phase~     II, to identify the clinical activity of the two study treatments when given in combination.~     The composition of Phase II will be selected at the end of Phase I.~      Approximately, up to 140 subjects and 154 subjects will receive study treatment in Phase I~     and Phase II respectively. A completed subject will be one who is followed until death.~   "
7084|NCT02964494|"~     The investigators propose the creation and maintenance of a comprehensive registry for~     patients with the diagnosis of Congenital Dyserythropoietic Anemia (CDA) in North America.~     The goal of this registry will be to collect long-term confidential data on patients with~     CDA in the US, Canada, and Mexico and create a bio-repository of de-identified patient blood~     and bone marrow specimens as a tool for the investigation of epidemiology, natural history,~     biology, and molecular pathogenetic mechanisms of CDA.~   "
7085|NCT02964481|"~     The purpose of this study is to to determine the penetrance of known and probable pathogenic~     variants in genes and the factors that contribute to penetrance in a population of children~     and adults in the United States exposed to Malignant Hyperthermia (MH) trigger agents.~   "
7086|NCT02964468|"~     The aim of this study is to evaluate the increase of radiation dose administered in patients~     diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity,~     using IMRT (concomitant boost technique).~   "
7087|NCT02964455|"~     The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of~     docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest~     radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.~   "
7090|NCT02964416|"~     Several modalities have been studied to prevent coughing during emergence, including~     extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no~     reliable method is recommended as standard of care. The advantages of administering tramadol~     includes a long duration of action, rapid recovery, limited depression of respiratory~     function and no effect on platelet makes it a safe medication to use for neurosurgical~     patients after craniotomy. The primary objective of the study is to observe the effect of~     single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic~     response (measurement of B.P and H.R) during extubation.~   "
7091|NCT02964403|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. The mechanism of~     indomethacin is dependent on COX-2 inhibitor.~      According to data, we design the project. The purpose of this study is to determine whether~     COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.~   "
7092|NCT02964390|"~     Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for~     non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).~      The aim of this study was to evaluate the safety and efficacy of BPA in patients~     disqualified from surgery or suffered from persistent CTEPH despite pulmonary~     endarterectomy.~      This is a interventional study analyzing the benefits and the risk of BPA. Clinical~     evaluation, including: functional capacity, 6-minutes walking test, haemodynamics,~     biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL~     assessment with Short Form 36 (SF36) questionnaire was performed before the initiation~     therapy of BPA, and 3-6 months after last session of BPA.~   "
7093|NCT02964377|"~     This single center open-label pilot study will enroll 15 non-ambulatory children with~     Duchenne muscular dystrophy at least 8 years of age and who demonstrate pre-clinical~     cardiomyopathy (defined as a cardiac ejection fraction >55% with abnormal LV strain by~     cardiac MRI). They will receive (+)-epicatechin at one of three doses during an 8-week~     dose-ranging study with assessments at baseline, 2 Weeks, 4weeks, and 8 weeks. The study~     will determine optimal dosing for future cardiac efficacy studies based on serum / plasma~     biomarker response using follistatin: myostatin ratio, nitrite/nitrate ratio, cardiac~     troponins and cardiac BNP. Secondary endpoints will include additional biomarker assessments~     by SOMAscanTM, cardiac functional evaluations by cardiac MRI (LV strain), and echocardiogram~     (LV strain by speckle tracking) and measures of strength, range of motion and mobility, and~     clinical safety assessments. Results of secondary endpoint analysis will be used to refine~     design of subsequent clinical trials powered to detect changes in clinical outcomes.~   "
7094|NCT02964364|"~     Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta~     and its major branches. The epidemiology and pathophysiology of TA is still unclear in~     China, although many studies have been done. Our previous study supporting by National~     Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and~     tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles~     were associated with TA in Chinese han population. Further investigations with larger~     samples are needed to fully understand the a pathophysiology of TA. The purpose of this~     study is to build a Chinese national registry system for TA to obtain real-world~     information, such as current status of characteristics, diagnosis, disease activity, the~     severity of disease, treatment and outcomes of Chinese TA patients. To analysis and~     development of effective disease monitoring and treatment strategies.~   "
7095|NCT02964351|"~     In our study, the investigators want to find correlation between circulating miRNAs~     associated with prostate cancer metastases to bones and to lymph nodes separately with~     results of 68Ga-PSMA ligand PET (positron emission computed) imaging.~   "
7096|NCT02964338|"~     The purpose of the current study is to evaluate the efficacy and safety of TEV-48125~     (Fremanezumab), in the prevention of CCH in adult patients.~   "
7097|NCT02964325|"~     This is a prospective, multi-center, controlled, randomized, non-inferiority study to~     evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis~     platelets in subjects with hypoproliferative thrombocytopenia who are expected to have~     platelet count(s) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.~   "
7098|NCT02964312|"~     To obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing~     placement of the Spirox Latera Implant with or without concurrent turbinate reduction~     procedures in an office setting.~   "
7099|NCT02964299|"~     The purpose of this study is to compare the effect of mandibular advancement bite block to~     standard bite block for prevention of hypoxemia, intervention events and adverse effects~     during endoscopic examinations.~   "
7100|NCT02964286|"~     In this proposed project, the investigator will estimate the effect of massotherapy of~     acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.~   "
7101|NCT02964273|"~     The primary objective of the study is to assess the long term safety of treatment with~     tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease~     (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and~     efficacy of tolvaptan in the same subject population.~   "
7102|NCT02964260|"~     This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE)~     simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half~     participants will receive TAE simultaneously combined with thermal ablation and the other~     half receive TACE sequentially combined with thermal ablation, which is a conventional~     treatment for HCC patients.~   "
7103|NCT02964247|"~     The trial is conducted in Asia, Europe, North America and South America. The aim of the~     study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an~     SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2~     diabetes mellitus.~   "
7188|NCT02963142|"~     Severe community acquired pneumonia is common and associated with high mortality.~     Conventional microbiological diagnostics identify pathogens in approximately half of cases,~     which is inadequate for both clinical and epidemiological purposes. This study applies~     next-generation sequencing based metagenomic techniques to patients with extremely severe~     community acquired pneumonia, to investigate the microbiome of severe community acquired~     pneumonia and evaluate metagenomic approaches as diagnostic tools.~   "
7104|NCT02964234|"~     The participatory-based project will quantify the 'added benefit' of an empowerment~     intervention relative to an education intervention for 150 Latinas on the following~     outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial~     facilitators (self-efficacy, norms, support, and knowledge); and women's dissemination of~     breast health messages throughout their social network. The empowerment intervention will~     train Latinas in how to discuss breast health with their family and friends and volunteer in~     local breast health promotion programs. Academic, clinician, and community partners will~     work together throughout intervention development and evaluation.~   "
7105|NCT02964221|"~     Patients assume that cognitive performance rapidly returns to baseline after anesthesia and~     surgery. Several studies have shown that one week after major non-cardiac surgery about 27%~     of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months.~     Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly~     reduces quality of life. Identifying risk factors for POCD is important because it is~     associated with prolonged hospital stay, loss of independence, and premature retirement.~     There is an urgent need to measure and document the level of cognitive change associated~     with surgery with an easy to use tool, both prior to admission and after discharge. This~     information can be used to plan appropriate care paths and to identify or test the efficacy~     of potential new treatments to alter the negative trajectory.~   "
7106|NCT02964208|"~     The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for~     use in preventing thrombus embolization from the LAA. The purpose of this study is to~     compile real world outcome data on the use of AMPLATZER LAA Occluder in subjects with~     non-valvular atrial fibrillation (NVAF)~   "
7107|NCT02964195|"~     The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of~     cirrhotic gastroesophageal variceal bleeding.~   "
7108|NCT02964182|"~     The goal of this research study is to learn more about the effects of different nicotine~     levels in cigarettes and electronic cigarettes (e-cigarettes). E-cigarettes use water vapor~     to deliver nicotine.~   "
7109|NCT02964169|"~     Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's~     health through family planning choices, regular health reviews, and support. A cohort study~     that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women~     having no desire for a (another) child during the 4 years since ART initiation, 51% had a~     serodiscordant partner, with only 45% using effective contraceptive method. Key predictors~     of contraceptive use were family planning goals within the DYAD. One of the key predictors~     of effective contraceptive use was male partner involvement and CD4 count. The WHO~     recommends dual contraception (use of condoms and a hormonal or permanent method) to prevent~     both HIV transmission and unwanted pregnancies (WHO,2014).This prospective intervention~     study aims at providing information on whether continuous family planning accessibility and~     support has a measurable impact on pregnancy intentions and contraceptive usage among~     postpartum HIV positive mothers delivering at MRRH, SW Uganda.~   "
7110|NCT02964156|"~     50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the~     forefoot are most frequently afflicted. Studies shows that foot problems can influence~     negatively on the walking function, physical activity and quality of life. Different foot~     orthoses and insoles are used as an intervention. Studies find that different insoles do~     have effect on pain, but there are no or minor effect on walking ability. The literature~     reports a further need for research and indicates the importance of studies on the effects~     of cost-effective insoles for patients with RA.~      Custom-built insoles takes time and are often expensive, and many patients, especially~     women, do not wear them since they often do not fit the shoes they prefer to wear. In this~     study, a 4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic~     textile material on the upper side is customized to provide support for the transverse and~     longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily~     customized and ready for use the same day. The purpose of this study was to determine~     whether this insole can reduce foot pain and increase walking distance in patients with RA~     and forefoot pain.~      An experimental study was performed on patients with RA and forefoot pain in either one or~     both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles~     (situation A) and without insoles (situation B). The order of situation A and B was~     randomized, and the assessor was blinded for the order of the two situations. Both tests~     were conducted the same day. After each test round, the patient was asked to register pain~     in the foot and perceived exertion. A telephone interview was conducted one year after the~     effect study to examine whether the insoles were still being used.~   "
7111|NCT02964143|"~     Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood,~     representing a powerful source of platelet-derived growth factors, particularly useful in~     the field of regenerative medicine. The active and sequential secretion of these growth~     factors induces different cell signaling cascades that activate angiogenesis, cell~     proliferation, cell differentiation, eventually leading to new matrix synthesis and tissue~     regeneration.~      The potential benefits from the use of PRP for the treatment of cartilage defects rely on a~     number of studies conducted in validated animal models or in vitro, demonstrating the~     ability of PRP to stimulate collagen production and proteoglycans synthesis, as well as the~     proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally,~     an increasing number of clinical studies shows an improvement of symptoms, most especially~     pain, without any occurrence of serious adverse events.~      Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the~     cartilage, assumes an important role in the viscoelastic properties of the articular~     cartilage, conferring its shock absorbing and lubricating functions.~      It was demonstrated that rheological properties of synovial fluid decrease with aging and in~     patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic~     acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms,~     conferring a mechanical action on joints structures, thus leading to reduced pain and~     improved joint function Based on these data, it seems reasonable to hypothesize that a~     combination of both PRP and hyaluronic acid could provide greater benefits compared to the~     administration of each product alone, as their effects on osteoarthritis improvement are~     based on different mechanisms of action. In fact, on one side PRP promotes cartilage~     regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP,~     providing optimal release of platelets growth factors, strengthening and extending in time~     the activity of PRP.~      Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company~     RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a~     non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA~     combination is intended to be injected intra-articularly, in order to relieve osteoarthritic~     symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might~     represent a novel therapeutic option for patient suffering from knee osteoarthritis.~      This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular~     MatrixTM when injected intra-articularly for the treatment of mild to moderate knee~     osteoarthritis, are superior in terms of mechanism of action, when compared to a~     well-recognized hyaluronic acid treatment (Ostenil® Plus).~   "
7189|NCT02963129|"~     Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients~     with HHT colonized with sataphylococo before and after being treated with mupirocin~     ointment.~   "
7112|NCT02964130|"~     This pilot study is part of a global project that aims to better define and understand~     features of FBSS/POPS post-operative persistent syndrome patients (shortened as FBSS in~     the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been~     defined as a chronic condition resulting from spinal interventions. Despite anatomically~     successful spine surgery, a significant proportion of patients is experiencing chronic~     refractory back and leg pain. In a recent multicentre study conducted on more than 100~     refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS~     diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might~     guide us to eventually develop a decision tool for identifying FBSS patients. Easing and~     helping diagnosis of FBSS should improve referral yield to specialists and accelerate~     patient flow through the care pathway. Hence, FBSS patients, who usually present a long~     standing history of pain, would have access to appropriate therapies earlier. This could~     lead to better outcomes. The aim of this multicentre, prospective study is to collect~     specific data that are not collected in routine in order to better define and understand the~     potential FBSS population and to accelerate the diagnostic and optimize the choice of~     appropriate treatment.~      A multidisciplinary approach through a pain management clinical network, as it has been~     structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and~     their care pathway will be collected. In addition, since the cooperation between orthopaedic~     and neuro spine surgeons is not a common relationship found all over Europe (as it is~     observed in Poitiers), this study also aims to better understand the development of~     interactions between physicians/professionals and the substantial advantage which would~     result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers~     to collect data and assess objectively pain surface and intensity changes, before/after any~     treatment, with quantitative measurements, will be used as the central key of this project.~   "
7113|NCT02964117|"~     Epidemiological investigations has suggested exposure to air pollution linked with~     respiratory disease, especially chronic obstructive pulmonary disease. However, the~     potential mechanisms of adverse effects remains scare. The present study will assess the~     association between air pollutants and respiratory related parameters to elucidate possible~     mechanisms.~   "
7114|NCT02964104|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in~     subjects with type 2 diabetes.~   "
7115|NCT02964091|"~     The main purpose of the study is to evaluate the efficacy, safety and tolerability of a~     medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic~     hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited~     laboratory monitoring to determine the minimum laboratory tests necessary.~   "
7116|NCT02964078|"~     The main purpose of this study is to evaluate the effects of the interleukin-2 given in~     combination with pembrolizumab.~      Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™.~      Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.~   "
7117|NCT02964065|"~     This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to~     evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated~     influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.~   "
7118|NCT02964052|"~     Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has~     been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 -~     70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile~     recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of~     comorbidity. In this regards, developing selection criteria using acute stroke imaging and~     comorbidity is warranted.~      Investigators will recruit the consecutive acute stroke patients who received IV~     thrombolysis and/or IA recanalization treatment. This study will perform with prospective~     design to develop CT-based clot, core and collateral scores and a comorbidity index for~     selecting stroke patients who are at high risks by the treatment. Investigators will firstly~     establish the CT-based scores and comorbidity index using a pre-existing cohort database.~     Using these CT-based and comorbidity index, Investigators will validate them in a~     multi-center prospectively cohort. In addition, Investigators will assess the~     cost-effectiveness of selecting patients based on the comorbidity index.~   "
7119|NCT02964039|"~     The purpose of this study is to determine whether a novel treadmill training intervention~     can improve the gait stabilization strategy used by individuals who have experienced a~     stroke.~   "
7120|NCT02964026|"~     The primary objective for this retrospective Electronic Health Record (EHR) analysis is to~     evaluate the clinical outcomes associated with the utilization of a pulmonary artery~     catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries~     (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures,~     other complex nonvalvular procedures and heart transplants). The study will be conducted~     using prospectively collected hospital inpatient data over a duration of over 5 years (Jan.~     1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts;~     Kansas City, MO).~   "
7121|NCT02964013|"~     This is a safety and pharmacokinetics study of MK-7684 as monotherapy and in combination~     with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no~     available therapy that is expected to convey clinical benefit. Part A of this study is a~     dose escalation phase. Part B is a dose confirmation phase to estimate the recommended Phase~     2 dose (RPTD) for MK-7684 monotherapy or in combination with pembrolizumab. The primary~     hypothesis is that MK-7684 administered as monotherapy or in combination with pembrolizumab~     is safe when administered at the RPTD.~   "
7122|NCT02964000|"~     Hypothesis: Use of high level vs low level cold laser treatments will reduce chronic pain~     and the need for PRN opioid-containing analgesic medications.~      Secondary Hypothesis: High level (vs low level) laser treatments will increase the patients~     level of physical activity and quality of sleep.~   "
7123|NCT02963987|"~     In this study, the investigators varied the portion size of all meals served during two~     5-day periods. During one period, baseline amounts of all foods and beverages were served,~     and during the other, the portion size of all items was increased by 50%. The primary aim of~     the study is to determine the effect of varying the portion size of foods and beverages~     served over 5 days on energy intake in preschool children.~   "
7124|NCT02963974|"~     This feasibility study evaluates whether children with unilateral, moderate to profound~     sensorineural hearing loss experience an improvement in speech perception, hearing in noise,~     localization, and quality of life with a cochlear implant as compared to an unaided~     listening condition.~   "
7286|NCT02961842|"~     The study will compare one technique of fluid administration (combined colloid preload and~     crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery~     performed under spinal anesthesia.~   "
7125|NCT02963961|"~     Postoperative delirium is a significant public health concern, affecting up to 70% of~     elderly patients presenting for surgery. Furthermore, postoperative delirium is associated~     with increased mortality, persistent cognitive decline, increased hospital length of stay,~     and elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies~     that consistently and effectively reduce the risk of delirium. In fact, although the~     American Geriatrics Society has released guidelines for the prevention of postoperative~     delirium, the evidence supporting many of the proposed preventive measures has been deemed~     low quality.~      Cognitive training exercises have been shown to improve cognitive function and functional~     status in community-dwelling elderly adults, and benefits may last for several months to~     years. Specifically, training exercises have led to improved performance in attention,~     short-term memory, and visuospatial processing; all of which are implicated as clinical~     features of delirium. Cognitive training has also strengthened connectivity in brain~     networks implicated in postoperative delirium. Thus, given these specific neurological~     benefits afforded, preoperative cognitive training may provide protection against the~     development of postoperative delirium. As such, the aim of this pilot study is to assess the~     feasibility of implementing a preoperative cognitive training program for surgical patients~     at high-risk for delirium and other associated complications.~   "
7126|NCT02963948|"~     This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and~     utilizing the CDEs in clinical practice requires a strategy for implementing screening to~     collect substance use information that populates the CDEs, and assisting primary care~     medical staff to offer appropriate interventions by providing clinical decision support~     (CDS) and a mechanism for making referrals to addiction treatment. Investigators aim to~     maximize the efficient adoption of screening, CDS, and treatment referrals by integrating~     all of these activities into the electronic health record (EHR). Incorporating the CDEs into~     the EHR also presents an opportunity to collect the NIDA/ASAM electronic clinical quality~     measure (eCQM), and we will seek to generate this measure following implementation of the~     CDEs.~      The study will be conducted at three sites, representing three large health systems. Each~     phase will include deliverables essential to move to the next phase, and an independent~     Advisory Committee will review progress and make recommendations at each transition about~     how best to progress to each subsequent phase. Based on progress during earlier phases, the~     Advisory Committee may recommend expansion to additional clinics or health systems during~     the second part of Phase 4.~   "
7127|NCT02963935|"~     This trial is conducted in the United States of America (USA). The purpose of the trial is~     to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive~     behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour~     Therapy for obesity in a primary care setting according to Centers for Medicare & Medicaid~     Services (CMS) visit schedule).~   "
7128|NCT02963922|"~     This trial is conducted globally. The aim of this trial is to investigate effect and safety~     of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus~     treated with basal insulin.~   "
7129|NCT02963909|"~     Phase 1 study to evaluate two doses of Alum Adjuvanted Zika Virus Purified Inactivated~     Vaccine (ZPIV) administered 28 days apart. The study will enroll 75 flavivirus naïve healthy~     adult subjects into 3 equal groups sequentially. Each group will include 20 ZPIV recipients~     and 5 placebo recipients. Group 1 will receive two ZPIV or placebo doses 28 days apart.~     Group 2 subjects will receive a two-dose regimen of IXIARO® 28 days apart; two ZPIV or~     placebo doses three months later 28 days apart. Group 3 subjects will receive one dose of~     YF-VAX® followed three months later by two ZPIV or placebo doses 28 days apart. A subset of~     up to 30 will be selected to receive a third ZPIV vaccination. The primary objectives are:~     1) To evaluate the safety and reactogenicity of a two-dose homologous prime boost regimen of~     ZPIV among flavivirus-naïve, YF-VAX® primed, and IXIARO® primed subjects; 2) To evaluate the~     safety and reactogenicity of a third dose of ZPIV in a subset of up to 30 subjects.~   "
7130|NCT02963896|"~     Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including~     postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom~     postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular~     symptoms postoperatively.~   "
7131|NCT02963883|"~     Postoperative erythrocytes transfusion is associated with morbidity and excess mortality,~     which should lead to ask the indication for RBC transfusions only on metabolic needs.~     Currently, the majority of studies used to put hemoglobin values indicating red cell~     transfusions. Two observational studies have confirmed that a transfusion strategy based on~     a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy~     than using the hemoglobin threshold values. We propose to conduct the first randomized~     multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac~     surgery using the ScvO2 each patient versus a threshold value usually recommended for all~     patients.~   "
7132|NCT02963870|"~     The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy~     (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse~     prevention.~      Since 2009, our team is engaged in a partnership between France and Quebec Interuniversity~     agreement concluded by a University Picardie Jules Verne-University of Montreal. In this~     context, two teams G4 (Amiens and Rouen) have received training in suicidal crisis,~     including the security plan by a university instructor and TCC Québec, Dr. Labelle.~     Furthermore, we complete a descriptive and prospective study of risk and protective factors~     for adolescent suicide in which the Quebec team of Professor Labelle contributes as an~     expert (sponsor: Rouen). 200 subjects were recruited on 2 years by 3 (CHU Amiens, CH~     Compiègne, CHU Rouen) with an assessment of recurrence at 1 year (lost rates of view = 15%).~     The first results highlight the central role of personal coping strategies (coping) in~     suicidal recurrence. We want extend this study to validate the implementation of the~     security plan (safety level) with suicidal adolescents. The security plan is the initial~     step of the TCC approach short of suicidal crisis. It is established after working with~     adolescents and their families (chain analysis of the suicidal crisis, coping~     self-evaluation and identification of support resources). Developed by Stanley B from~     Columbia University and adapted for francophone adolescents R Labelle and JJ Breton wrote~     this list those resources and coping strategies to apply in case ideation and suicidal~     crisis. Signed by the young person and his family, he then uses to frame the monitoring and~     management plan of the youth and his family environment, friendly and professional in case~     of suicidal crisis.~   "
7134|NCT02963844|"~     Introduction: Obstructive sleep apnea (OSA) is characterized as a disorder that causes~     recurrent episodes of partial or complete obstruction of the upper airways during sleep.~     Objectives: In this way, the study will investigate the efficacy of inspiratory muscle~     training in improving the severity of obstructive sleep apnea and sleep quality of the~     research participants. Methods: The investigators will invite individuals of both sexes~     diagnosed with obstructive sleep apnea moderate and / or severe, arising from the Sleep~     Laboratory of the Hospital PROCAPE, located in Recife. This is a randomized-controlled~     trial, double-blind to be held in two groups: A) Individuals with OSA (moderate or severe) -~     Experimental Group: The components of this group hold the IMT with load of 75% of Pimáx. (~     assessed weekly) for eight weeks. B) Individuals with OSA (moderate or severe) -Group~     control: This group will simulate training, performing no-load training for the same period~     the intervention group. All guidance on training and weekly evaluations will be made by the~     responsible for the research physiotherapist in Cardiopulmonary Physiotherapy Laboratory~     (LACAP - UFPE). Before and after the eight weeks, the groups will be evaluated by~     polysomnography, acoustic pharyngometry, tests for respiratory muscle strength~     (Manovacuometry) and lung function (spirometry). Expected results: Improvement of severity~     of OSA and sleep quality of research subjects after the completion of eight weeks of TMI~     when compared to the control group.~   "
7135|NCT02963831|"~     This is a two-part Phase 1/2 dose escalation and dose expansion study of the GMCSFencoding~     adenovirus, ONCOS-102, in combination with anti-programmed death ligand-1 (PDL1) antibody,~     durvalumab, in adult subjects with peritoneal disease who have failed prior standard~     chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial~     ovarian cancer or colorectal cancer.~   "
7136|NCT02963818|"~     Exploring technology based tools to reduce drinking is important. The purpose of this~     research study is to compare different BAC monitoring apps for their effects on alcohol~     drinking and ratings of usability among young adults.This study will be conducted in six~     phases: a web-based and in-person screening assessment; brief counseling session on the day~     before the alcohol drinking session; brief appointment on the day of the alcohol drinking~     session; alcohol drinking session; two-week field period; and a follow-up appointment.~     Participation in this study will last approximately two months.~   "
7137|NCT02963805|"~     The purpose of the A-CLASS project was to measure the effect of the 4 hour offer on~     children's physical activity, health and physical competence.~   "
7138|NCT02963792|"~     Due to their difficult and stressful work surgeons are under continuous physical and mental~     stress exposing them to increased risk for burnout and lack of professionalism. The present~     intervention focuses on providing time and a safe space to debrief and explore personal and~     group experiences and dilemmas, as well as acquire coping skills related to burnout,~     communication and professionalism.~   "
7139|NCT02963779|"~     This study is conducted to determine the side effects related to LY2775240 given orally to~     healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into~     the bloodstream and how long the body takes to get rid of it. Each participant will enroll~     in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks~     respectively, including screening.~   "
7140|NCT02963766|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and~     pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants~     with type 2 diabetes. The study duration is approximately 60 weeks.~   "
7141|NCT02963753|"~     Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a~     clinical syndrome including endocrine and metabolic complications. Recently, some~     investigators have been begun performing researches related to the development of~     gestational diabetes mellitus (GDM) in pregnant women with HEG because they think about~     those metabolic and endocrine complications of HEG.In the literature there are few studies~     assessing how HEG has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the~     investigators aim to evaluate the effects of HEG on 75 gram OGTT.~   "
7142|NCT02963740|"~     The purpose of the study is to demonstrate that breast cancer survivors who need to lose~     weight are able to follow a weight loss program which combines modest calorie restriction~     with a graduated activity program..~   "
7143|NCT02963727|"~     Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed~     with Knee osteoarthrosis~   "
7144|NCT02963714|"~     Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a~     four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates~     are inadequate and persistence of immunity remains a challenge.~      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune~     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three~     injections at months 0, 1, and 6 in hemodialysis patients.~   "
7145|NCT02963701|"~     The objective of the current study is to demonstrate bioequivalence of a fixed dose~     combination tablet containing ibuprofen 400 mg and pseudoephedrine-HCl 60 mg (Test) and two~     tablets RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg~     and pseudoephedrine-HCl 30 mg following orally administration with respect to both analytes,~     ibuprofen and pseudoephedrine-HCl.~   "
7146|NCT02963688|"~     PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2~     mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial~     ovarian cancer (EOC).~      PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between~     2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA~     1/2 mutation, regardless of the family history. Mutation screening was performed using the~     Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform~     according to the manufacturer's instructions. Clinical characteristics including survival~     outcome was assessed in gBRCAm carriers.~   "
7147|NCT02963675|"~     This study is conducted to obtain information about prostate cancer patients with bone~     metastases before the end of 2013. The incidence of second primary malignancies and overall~     survival in patients with castration resistant prostate cancer are of particular interest.~     Information from this study will serve as a historical reference for the REASSURE study~     (Background incidence study)~   "
25509|NCT02723279|"~     The purpose of this study is to compare the efficacy of electrical pudendal nerve~     stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.~   "
7148|NCT02963662|"~     Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat~     to our national life and health which is showing a trend. Bariatric Surgery had been~     confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic~     gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2~     diabetes, but the two surgical methods and principles are completely different, which~     mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines~     and inflammatory cytokines induced chronic inflammation and obesity-related complications~     (insulin resistance and Type 2 diabetes).It is not clear whether to change these~     gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the~     operation, which play a therapeutic effect of obesity-related complications and diabetes. In~     addition, the investigators are wonder whether gut hormones, adipokines and inflammatory~     cytokines have some correlation in different severity obese patients,. It is worth to~     explore that could intestinal hormones, adipokines and inflammatory factors levels guide us~     to choice the different surgical approach to different severity obese patients. The~     investigators tried to investigate different surgical methods to alleviate diabetes and~     other metabolic diseases mechanisms though hormones and inflammatory factors and adipose~     tissue inflammation level and compare the impact of intestinal hormones and inflammatory~     adipokines of the two surgical approaches.~   "
7149|NCT02963649|"~     To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus~     conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with~     chronic total occlusions in the infrapopliteal arteries.~   "
7150|NCT02963636|"~     The project objective is to evaluate the impact of the recent addition of pharmacists within~     family medicine groups (FMGs) on organizational and clinical parameters. The process by~     which changes occur and the level of pharmacists' activities will also be assessed. The~     ultimate goal of the project is the development of an accompanying guide to facilitate the~     work of the pharmacist in monitoring complex patients in primary care medical clinics.~   "
7151|NCT02963623|"~     Intraoperative thromboelastometry has been used in patients undergoing cardiac surgery and~     it was preferred than conventional coagulation tests because it is available within short~     time and could be the guide of haemostatic therapy and it could reduce transfusion~     requirements. Recently, a retrospective study revealed that the early variables assessed by~     rotational thromboelastometry could predict maximal clot formation and might be helpful in~     managing severe bleeding in non-cardiac surgical patients. The incidence of total hip or~     knee replacement arthroplasty has continuously increased because of the growth of aging~     population. These surgery lead to postoperative bleeding, sometimes patients need~     transfusion. Fibrinolysis seems to have a key role in clot formation in postoperative period~     after major orthopaedic surgery. Fibrinolysis activation began at implantation in total hip~     replacement arthroplasty, and the rate of fibrinolysis peaked after tourniquet release in~     total knee replacement arthroplasty. Fibrinolysis in both appeared to decrease after two day~     following surgery. Therefore, the authors assumed that functional assessment of haemostasis~     by rotational thromboelastometry could provide information about the amount of postoperative~     bleeding in total hip or knee replacement arthroplasty patients.~   "
7152|NCT02963610|"~     For the phase I component of the trial a classic 3 + 3 dose escalation design will be~     utilized, with a fixed dose of pembrolizumab and an escalating dose of the lenalidomide. The~     patient population will all have histologically confirmed advanced solid tumor malignancy.~     The primary endpoint for the phase I component of this protocol will be determining the~     maximum tolerated dose (MTD) of lenalidomide in combination with pembrolizumab.~      The phase II component of this trial will utilize a two stage design, initially enrolling 13~     patients, followed by 13 more patients if the early stopping criteria are not met. The~     target population will include patients with histologically confirmed diagnoses of non-small~     cell lung carcinoma, regardless of histologic subtype; who have completed one line of~     standard therapy. The primary endpoint for the phase II component of this protocol will be~     determining efficacy as measured by progression free survival (PFS)~   "
7153|NCT02963597|"~     The objective of the study is to evaluate the effect of continuous positive airway pressure~     (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF)~     patients with obstructive sleep apnea (OSA). The study will also assess changes in~     functional parameters, biomarkers, and echocardiographic parameters.~   "
7154|NCT02963584|"~     The aim of this study is to assess the feasibility and validity of patient-level~     randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.~   "
7155|NCT02963571|"~     To validate the safety and effectiveness of minimally invasive posterior percutaneous~     pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior~     spinal column injury.~   "
7156|NCT02963558|"~     This proposal will test the hypothesis that EARLY application of a novel early~     rehabilitation therapy in critically ill patients will improve functional outcomes, and~     change the functional trajectory of this population. A pilot study of early mobilization~     with a cycle ergometer will be performed and translate into humans the pre-clinical~     mechanisms that may mediate the effects of early mobility.~   "
7157|NCT02963545|"~     Single-center, prospective, descriptive and biomedical research with controls, without~     health product.~      Depression is the second risk factor for stroke as tobacco smoking following hypertension.~     Peripheral abnormalities in serotonin parameters were described in depression and tobacco~     smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT),~     which has notably complex vasomotor effects and of kynurenine which could have cognitive~     dysfunction effects.~      The aim of this study is to evaluate simultaneously the involvement of serotonin and~     kynurenine pathways parameters in patients suffering from a cerebral infarction shortly~     after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2)~     and 3 months after the cerebral infarction.~   "
7190|NCT02963116|"~     This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center,~     crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of~     rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs~     AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy~     Volunteers. The study will be performed at a single study center.~   "
43133|NCT02492412|"~     The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the~     patients with moderate to severe dry eye syndrome.~   "
7158|NCT02963532|"~     The timing of extubation following surgery and anesthesia in young children is a complex~     decision frequently guided by the experience of the clinician. The clinician frequently must~     make a decision based on assimilating multiple cues that may or may not demonstrate that the~     patient is ready for extubation such as eye opening, conjugate gaze, spontaneous~     ventilation, and end tidal agent concentration. At this time there is no published data on~     the predictive ability of individual extubation criteria for young patients undergoing~     anesthesia for surgery so most practice is based solely on experience and anecdotal~     teaching. In some cases if the timing is misjudged and the patient is extubated too early~     negative airway reflexes such as breath holding and laryngospasm may take over creating a~     critical situation in which the patient forgoes gas exchange and rapidly desaturates with~     the potential for bradycardia and further cardiovascular collapse.~      Routine criteria used to determine fitness for extubation have been primarily described in~     the intensive care unit literature and may be less relevant in the operating room in the~     setting of routine general anesthetics. Most predictors including adequate tidal volume,~     presence of conjugate gaze, eye opening, patient movement purposeful or otherwise, low end~     tidal anesthetic agent concentration, response to physical or verbal stimulation and the~     laryngeal stimulation test have not previously been evaluated to determine their individual~     predictive value in deciding if the presently anesthetized patient now emerging is ready to~     be extubated.~      In order to perform a laryngeal stimulation test the patient must be breathing spontaneously~     and practitioner will gently move the endotracheal tube up and down stimulating the larynx.~     In patients in stage 2 of anesthesia, the clinician will typically observe a cough or series~     of coughs followed by a respiratory pause of greater than 5 seconds. In this situation the~     patient has not adequately passed through stage 2 and remains at increased risk for apnea,~     breath holding, or laryngospasm. If the patient is in stage 1 of anesthesia the clinician~     will observe a cough followed by a brief pause (less than 5 seconds) or almost immediate~     return to spontaneous ventilation.~      In conclusion, their exist no quantitative data on the predictive value of these various~     criteria for extubation and the goal of our study is determine the indivdual predictive~     value of different criteria in determing fitness for extubaion in young pediatric patients~     by recording the presence or absence of various criteria in pediatric patients at the time~     of extubation during routine anesthetic care.~   "
7159|NCT02963519|"~     Primary objective:~      Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates~     the formation of a quality granulation tissue and reduces preparation time to a cover~     gesture.~      Secondary objectives:~        -  Evaluate the success of hedging gesture~        -  Assess the quality of the bud by colorimetry~        -  Assess tolerance~        -  Collect medical and economic data on the care of patients included~        -  Evaluate the quality of life of patients~        -  Assess patient comfort~        -  Evaluate the ease of use for the caregiver~   "
7160|NCT02963506|"~     This is a study to evaluate the efficacy and safety of different doses of bimekizumab in~     subjects with active Ankylosing Spondylitis (AS).~   "
7161|NCT02963493|"~     This study will evaluate melflufen in combination with dexamethasone in the treatment of~     relapsed refractory multiple myeloma in adult patients with disease refractory to~     pomalidomide and/or daratumumab. All patients in the study will be treated with melflufen on~     Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.~   "
7162|NCT02963480|"~     Similar to poly-trauma, acute myocardial infarction, or stroke, the speed and~     appropriateness of therapy administered in the initial hours after severe sepsis develops~     are likely to influence outcome. However, the crux of matter is the early diagnosis~     lacking of high sensitive and specific test, in contrary to, for instance, the acute~     coronary syndrome, where the highly sensitive Troponin T is measured and increased values~     are fix component of the diagnosis and definition of acute myocardial infarction. Cardiac~     surgery can initiate a systemic inflammatory response syndrome (SIRS) induced by extrinsic~     and intrinsic factors, which are associated in the pathogenesis of postoperative~     complications. SIRS is closely related to sepsis, but in contrast sepsis is induced by~     infection. This strong inflammatory response induces malfunction of the peripheral~     circulation with increased lactate levels, pronounced fluid accumulation and increased need~     of vasopressors.~      The investigators want to assess the timing dynamic of release of IL-6 apart from~     established markers like CRP, leukocytes, PCT. Target of this is to estimate the time-scope~     and -advance of an IL-6 axis panel toward the measurement of standard inflammation~     parameters in inflammatory response to surgical trauma as a pre-figuration of non-infectious~     SIRS and to search for a eligible cut-off of IL-6.~   "
7163|NCT02963467|"~     Smoking is one of the world's leading health hazards. Besides being a major risk factor in~     the etiology of COPD and lung cancer, cigarette smoke is also a causative agent lung~     diseases characterized by bronchiolar and interstitial inflammation. However, the associated~     lung pathology of smoking is not only a risk in the development of lung diseases, but also~     widely recognized as a major risk factor associated with perioperative respiratory and~     cardiovascular complications. Apart from the long term effects of cigarette smoke, acute~     effects of the inhalation of cigarettes smoke may influence the course of lung pathology.~     The inhalation of smoke causes inflammation in the lung by inducing chemotaxis and~     activation of neutrophils and macrophages and induces oxidative stress. As the acute~     inflammatory response to smoke inhalation seems to be the underlying mechanism for chronic~     diseases of smokers, exploring the field of the acute pulmonary changes after exposure to~     cigarette smoke is highly relevant. One reason for acute hypoxia and injury during smoking~     might be a severe mismatch of ventilation and perfusion of the lung. Using the multiple~     inert gas elimination technique (MIGET), a distribution of ventilation-perfusion ratios in~     the lung can be calculated by analyzing data on the retention and excretion of six infused~     inert gases. A saline solution containing the gases is infused intravenously. When passing~     through the lung the gases are either eliminated from the blood or retained depending on~     their partition coefficient and local V/Q ratio. The concentrations of the gases are~     measured in the mixed venous blood or the mixed expired gas and the arterial blood allowing~     for the calculation of retention and excretion and the derivation of V/Q distribution. MIGET~     is the experimental gold standard to determine the Ventilation-Perfusion ratio of the lung.~     The aim of this study is to show the acute effect of smoking on ventilation/perfusion ratio~     distribution in the lung in otherwise healthy smokers.~   "
7164|NCT02963454|"~     To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in~     the extracellular fluid of the skeletal muscle following levosimendan administration in~     patients with septic shock.~   "
7165|NCT02963441|"~     Diabetes affects 29.1 million people or 9.3% of the population of the United States. Results~     of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes~     patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe,~     vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative~     diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as~     much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR~     and/or diabetic macular edema. Despite effective treatment however, tens of thousands of~     people with diabetes are going blind each year largely because they don't undergo annual~     screening for retinopathy. Currently, only some 50%-60% of people with diabetes have a~     yearly eye exam and there may not be enough eye specialists to see the balance.~      To address the issue of patient compliance with diabetic retinopathy screening, IDx-DR was~     developed as an automated screening device designed to analyze fundus images for the~     presence of lesions and other disease features associated with diabetic retinopathy. This~     study has been designed to validate the safety and efficacy of the device at the frontlines~     of healthcare.~   "
7166|NCT02963428|"~     The study aims to improve obstetrical care by managing gestational weight gain (GWG) among~     high risk women in an effort to reduce maternal and fetal complications.~   "
7191|NCT02963103|"~     The objective of this study is to observe and evaluate the change in renal function~     following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based~     one.~   "
7170|NCT02963376|"~     Stroke is the fifth leading cause of death in the United States and is the leading cause of~     long term disability. Distinct geographic disparities in stroke mortality, with highest~     rates in the southeast United States including Arkansas, are known as the stroke belt.~     There the average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke~     is the leading cause of serious long-term disability. Between 2012 and 2030, disability and~     medical costs related to stroke are projected to triple, from $71.6 billion to $184.1~     billion, with the majority of the projected increase in costs arising from those 65 to 79~     years of age.~      There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in~     85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion~     of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue~     plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood~     vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it~     reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond~     the effective time window for therapy is a common reason for failure.~      To reduce the devastating impact of stroke on individuals and society, the investigators~     continue to seek ways to improve functional recovery and limit ischemic damage in stroke~     patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has~     recently shown strong positive effects in pre-clinical animal models of acute ischemic~     stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants~     and blood substitutes yet none have been successful.~   "
7171|NCT02963363|"~     The purpose of this study is to assess the feasibility of a home-based adapted physical~     activity during neoadjuvant chemotherapy for HER2+ breast cancer.~   "
7172|NCT02963350|"~     -  To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a~          clinical trial.~        -  To collect additional information on the safety and tolerability of BMN 190~          administration in patients with CLN2 disease.~   "
7173|NCT02963337|"~     Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and~     pharmacokinetic profile. As compared to epidural analgesia, it demonstrated satisfactory for~     pain relief at the beginning of labour with a gradual elevation of pain scores as labour~     progresses. However, fast onset and limited time efficacy may render it useful in~     multiparous with a faster labor progression, thus even making it an alternative to~     single-shot spinal analgesia.~   "
7174|NCT02963324|"~     The present study assesses the pharmacokinetic profile of Ivermectin (IVM) in healthy human~     volunteers and aims to create a physiologically-based pharmacokinetic model. Planned~     indication is the prevention of malaria transmission.~   "
7175|NCT02963311|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC~     in participants with homozygous familial hypercholesterolemia.~   "
7176|NCT02963298|"~     Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac~     arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after~     cardiac arrest.~   "
7177|NCT02963285|"~     The purpose of this study is to determine the optimal range of insertion depths for a~     nasopharyngeal probe in anesthetized pediatric patients as a function of age.~   "
7178|NCT02963272|"~     Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2~     years, 30% of rehospitalization within 1 month). It is also a major cause of health burden~     representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these~     costs are due to hospitalization.~      Besides physical examination and echocardiography, biology may help refine the diagnosis,~     but also could provide powerful prognostic parameters.~      This study aims to assess the value of ST2 in the management of patients admitted for HF to~     reduce readmission at one month.~   "
7179|NCT02963259|"~     This post-marketing evaluation has been designed to consistently investigate the subject's~     preference when switching from a Medtronic® constant voltage or constant current device to a~     St Jude Medical Infinity™ or St Jude Medical BrioTM constant current system. As electrodes~     will not be re-positioned, differences in subject's preference are to be explained by the~     difference in shape of the delivered pulse or waveform between the two systems.~   "
7180|NCT02963246|"~     Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual~     control group in patients with bowel disease. Design: randomized controlled trial. Setting:~     Outpatient setting. Population: patients who attended bimonthly check up.~   "
7181|NCT02963233|"~     The treatment of pediatric supracondylar humerus fractures is controversial, but despite the~     injury's high incidence there is a lack of high level evidence to guide operative versus~     non-operative decision making for displaced fractures with an intact posterior cortex~     (Gartland Type II). This study aims to prospectively compare clinical, functional, and~     radiographic outcomes between operatively and non-operatively treated patients using a~     prospective multi-centre cohort design.~   "
7182|NCT02963220|"~     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for~     avoidant/restrictive food intake disorder (ARFID) in 10 youth with ARFID (ages 10-21y).~   "
7183|NCT02963207|"~     OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an~     established one for colorectal lesions in a randomised trial between 2013 and 2015.~   "
7184|NCT02963194|"~     To determine whether the neuropeptide oxytocin (OXT) influences self-processing by~     investigating whether it increases the endowment effect in relation to both self and others.~   "
7185|NCT02963181|"~     Neurogenic Orthostatic Hypotension (NOH) is clinically defined as a consistent drop in~     systolic blood pressure (SBP) ≥30mmHg upon standing from a seated or lying position.~     However, 50% of NOH patients also have associated supine hypertension. It has been proposed~     that supine hypertension is the result of intact post-ganglionic sympathetic nerves and~     therefore due to residual sympathetic tone. Furthermore, research investigating the effects~     of melatonin shows blood pressure implication of this naturally secreted hormone.~     Specifically, melatonin has been investigated as a non-traditional anti-hypertensive agent~     for patients with essential and nocturnal hypertension. Central and peripheral mechanisms~     have been proposed to help explain how melatonin reduces blood pressures. Therefore, we aim~     to identify NOH patients as having either intact or denervated post-ganglionic sympathetic~     nerves, monitor the correlation to supine hypertension and subsequently investigate the~     effects of melatonin on blood pressure in these patients.~   "
7192|NCT02963090|"~     This is a multi-institutional, randomized, open-label phase II study of pembrolizumab~     compared to topotecan, administered to patients with SCLC who have progressed or relapsed~     after first-line treatment with etoposide and platinum. Patients will be randomized in a 2:1~     fashion to receive pembrolizumab or topotecan. Participants in the topotecan arm that~     progress will be allowed to cross-over to the pembrolizumab arm.~   "
7193|NCT02963077|"~     The primary objectives of the study are to evaluate the safety, tolerability and~     pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In~     addition, will evaluate A4250 in combination with cholestyramine.~   "
7194|NCT02963064|"~     This is a single-arm, open label, Phase 1 study to assess the safety and tolerability of~     CD34+CD90+ hematopoietic stem cell (HSC) allografts infused into patients with SCID who are~     conditioned for transplantation with AMG 191, an antibody that targets CD117 present on~     endogenous HSC. The target dose of CD34+CD90+ HSC will be >1 x 10^6 cells/kg and the optimal~     conditioning dose of AMG 191 will be determined during dose escalation.~   "
7195|NCT02963051|"~     The purpose of this study is to determine the safety and optimal dosing of intravenous~     copper chloride and disulfiram in men with metastatic castrate-resistant prostate cancer~     (CRPC). Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC~     with non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC~     with liver and/or peritoneal metastases. Subjects will receive three doses of intravenous~     copper chloride and take disulfiram and oral copper gluconate until disease progression (up~     to two years). Subjects will also undergo a PET scan with radioactive copper 64 to measure~     the levels of copper in their tumor. The central hypotheses of this project are that (a)~     copper chloride and disulfiram are safe to give together and that (b) the combination of~     disulfiram with copper will have efficacy for both mCRPC and NEPC.~   "
7196|NCT02963038|"~     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and~     efficacy in patients with B cell malignancy including lymphoma or leukemia.~   "
7197|NCT02963025|"~     One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow~     or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a~     mechanical ventilation approach that is able to maintain adequate gas exchange, while~     protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the~     use of lower tidal volumes is helpful to avoid over-distension, but can result in increased~     atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels~     of positive end-expiratory pressure (PEEP).~      Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that~     this may improve oxygenation and protect against PPC. Up to now, it is not known whether~     high levels of PEEP combined with RM are superior to lower PEEP without RM for protection~     against PPCs during OLV.~      Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and~     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without~     recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing~     thoracic surgery under standardized one-lung ventilation.~   "
7198|NCT02963012|"~     A prospective trail. Pregnant women in the first trimester with positive BHCG and no~     visualization of gestational sac will be recruited.~      The correlation between endometrial pattern and ectopic pregnancy will be assessed.~   "
7199|NCT02962999|"~     Chronic obstructive pulmonary disease (COPD) patients often undergo thoracic surgery due to~     lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery~     aggravates hypoxia and hypercapnia increasing intrapulmonary shunt and dead space.Ketamine~     provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It~     also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of~     ketamine on arterial oxygenation, the shunt fraction and the lung mechanics in patients with~     COPD who administered OLV because of thoracic surgery. Thirty patients with COPD who undergo~     thoracotomy for lung lobectomy will be included in this study. Patients will be randomly~     divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be~     administered 0,5 mg/kg/hour ketamine infusion after the induction, CG will be administered~     saline infusion. Peak airway pressure (Ppeak), plato airway pressure (Pplato), static~     compliance, shunt fraction and arteriel blood gas values (Pa02, PaC02) will be recorded~     before initiation of OLV and 30 minutes intervals after initiation of OLV.To evaluate the~     postoperative pulmonary complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be~     recorded 20 minute after arrival at postoperative care unit. Patients will be evaluated for~     pneumonia, atelectasis and acute lung injury at postoperative 72 h and findings will be~     recorded. 30 day mortality will be recorded.~   "
7200|NCT02962986|"~     Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and~     can have unwanted side effects on both mother and fetus if not treated promptly.~     Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although~     phenylephrine is safe to use for this indication, it has been associated with reflex~     bradycardia and a reduction in cardiac output.~      Norepinephrine is a potent vasopressor used to treat hypotension in the critical care~     setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and~     have shown that it can be used safely and also has favourable hemodynamic properties when~     compared to phenylephrine, with less bradycardia and less depression of cardiac output.~      The investigators recently conducted a study to determine the ED90 of norepinephrine, and~     now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension~     following spinal anesthesia for cesarean section.~      The investigators hypothesize that norepinephrine, when given as a bolus to prevent post~     spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia~     when compared to phenylephrine in patients undergoing elective cesarean delivery under~     spinal anesthesia.~   "
7201|NCT02962973|"~     The purpose of this clinical investigation is to evaluate the safety and performance of the~     Carmat Total Artificial Heart (TAH) in patients suffering from advanced heart failure and~     requiring biventricular support.~      Each subject receiving the Carmat TAH is followed to the primary and secondary endpoints at~     6 months, with a subsequent follow-up period extending to 2 years post implant.~      The results of the study will be used to support a CE mark application.~   "
7224|NCT02962674|"~     The purpose of this study is to evaluate the safety and performance of the ProstaCare System~     in relieving symptoms of urinary outflow obstruction secondary to benign prostatic~     hyperplasia.~   "
7202|NCT02962960|"~     This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and~     tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult~     Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result~     and active skin manifestations while receiving Standard of Care (SOC) treatment. In~     addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.~   "
7203|NCT02962947|"~     The effectiveness of propranolol in infantile hemangiomas, the apparent better response to~     propranolol in breast cancer and the use of propranolol in a proportion of patients who did~     not develop melanoma recurrence suggested to use this unselective β---blocker to test the~     study hypothesis. The investigators propose a randomized double---blind placebo---controlled~     clinical trial (RTC) to evaluate whether the treatment with propranolol 80 mgR/die reduce~     the risk of CMM recurrence and mortality. Patients with resected stage II/IIIA CMM will be~     recruited in various Centers in Italy. Participants will be randomly assigned to propranolol~     treatment or placebo (1:1 ratio), treated for at least 1 year and followed for 2 years.~     Recruitment will proceed simultaneously at the different Centers, and will be completed in 2~     years. The primary outcome of the entire trial will be, however, estimated by assessing a~     reduction in overall mortality at five years. The investigators will also evaluate general~     CMM recurrence and CMM specific mortality.~   "
7204|NCT02962934|"~     The purpose of this study is to try to find out how critically ill patients receiving the~     antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to~     study if the antibiotic concentrations during a dose of this antibiotic reaches the right~     concentrations necessary to kill the bacteria that is causing the infection. The process by~     which a drug travels through the body in blood, how it is broken down and removed by the~     body is called pharmacokinetics (PK). We can measure the PK by taking blood samples at~     specific times after the antibiotic is given.~      Investigators would like to do the study in patients receiving dialysis and patients who are~     not receiving dialysis. This information about how the antibiotic is processed in the~     critically ill patient is unknown and it is important to know whether the doses doctors give~     patients to fight infection are adequate. If antibiotic concentrations are low in the blood,~     it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to~     the antibiotic being less effective against bacteria potentially exposing future patients~     with infections to a limited range of effective antibiotics.~      Patients will be consented, and given the antibiotic as prescribed. Blood samples will be~     taken from the drip that is already in the patients arm just as the antibiotic starts, at 15~     and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the~     blood samples taken from the dialysis machine before the blood reaches the dialysis filter~     (same blood samples as the non dialysis patients) and also bloods samples taken after the~     filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of~     ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the~     dialysis process. The total amount of blood will be 40mls which is equal to about 2~     tablespoons. The dialysis patient will have 50mls of blood taken.Information about the~     patients ICU stay will also be recorded.~   "
7205|NCT02962921|"~     Our investigation studies the role of acute insulin administration on the diabetic heart,~     its corresponding effective blood-insulin level and the time-course applicability of insulin~     in a routine clinical setting.~      A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ±~     0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose~     homeostatic, hemodynamic and echocardiographic systolic and diastolic parameters at baseline~     and following two successive insulin-load steps of a euglycemic hyperinsulinemic clamp~     study, each 2 h in duration. Results are presented as a mean ± SEM and analysed using the~     student's t-test.~   "
7206|NCT02962908|"~     FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of~     this study is to measure the immune responses induced by FLU-v vaccine. This study will look~     at how safe FLU-v is when administered and how successful it is in preventing flu or~     reducing the severity of the flu symptoms.~      The study requires 222 healthy volunteers 18-60 years old. Participation in the study will~     take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be~     examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample~     (a tablespoon) will be taken to check general health followed by a general physical exam.~     Medical history and some personal information will be collected. Subjects that have received~     the traditional flu vaccine in the past 6 months, and those females who are pregnant or~     breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to~     use effective contraceptive methods.~      At visit 2, subjects will be randomly allocated to one of the four treatment groups~     summarised below:~        -  Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21~          days later~        -  Treatment 2: FLU-v (test vaccine) with an additional substance added [known as~          Montanide ISA 51] which improves the effect of the test vaccine. Injection will be~          given on Day 0 and then Placebo (no test vaccine) alone 21 days later~        -  Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later~        -  Treatment 4: Placebo (no test vaccine) with an additional substance added [known as~          Montanide ISA 51] on Day 0 and then Placebo (no test vaccine) alone 21 days later~          Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21~          days later (visit 3). Blood samples will be taken before treatment (day 0), and on days~          42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine.~      Subjects will be asked to complete a diary card to write down any side effects that they may~     experience after vaccination. Subjects will also be asked to complete another diary card to~     document any flu-like symptoms experienced between December 2016 and March 2017, this time~     is officially considered as the flu season. During this period, if the subject experiences~     flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site~     to confirm whether they have the flu or not.~   "
7207|NCT02962895|"~     This study will determine the dose-response relationship of VAY736 for key efficacy and~     safety parameters~   "
7208|NCT02962882|"~     A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User~     Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury~     Prevention in the Intensive Care Unit~   "
7209|NCT02962869|"~     To evaluate the potential of a test material to produce a photoallergic response~   "
7210|NCT02962856|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
7211|NCT02962843|"~     The purpose of this study is to evaluate whether training teacher and staff in the~     Incredible Years (IY) Teacher Classroom Management (TCM) program reduce behavior problems~     and promote social competence in student aged 6-8 years (school) and in children aged 3-6~     year (day-care). To examine group differences from baseline to 8-9 months after, a~     quasi-experimental control group design with pre- and post-measurements was used.~   "
7212|NCT02962830|"~     The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology~     (e.g., malformation) or a diagnostic or therapeutic procedure.~      To date, there is very little data and no consensus on fetal analgesia. The aim of the~     investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic~     injection.~   "
7225|NCT02962661|"~     The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)~     to standard of care drugs can help control heart failure that may have been caused by~     anthracyclines. The safety of the MSCs will also be studied.~      MSCs are a type of stem cell that can be removed from bone marrow and grown into many~     different cell types that can be used to treat cancer and other diseases, such as heart~     failure. The MSCs used in this study were collected from healthy donors and are stored and~     grown in a lab at MD Anderson.~   "
7226|NCT02962648|"~     Evaluation of safety and efficacy of IV iron isomaltoside re-dosing.~   "
8837|NCT02941536|"~     This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic~     radiotherapy, in single or fractionated dose, and correlate with the local and distant brain~     progression-free survival in patients with metastatic breast cancer.~   "
7213|NCT02962817|"~     Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes~     of primary care physicians and nurses towards the treatment of chronic nonspecific low back~     pain to subsequently develop a biopsychosocial educational tool using a web platform. The~     secondary aim of this project is to evaluate the effectiveness of this educational~     intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for~     primary care physicians and nurses.~      Methods: Exploratory sequential mixed method design. For the qualitative phase of this~     study, researchers will use personal semistructured interviews. For the quantitative phase~     the authors will use an experimental study design.~      Subjects: medical and nursing staff working in primary care centers in the city of Lleida,~     Spain.~      Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about~     chronic low back pain of physicians and nurses working in primary care settings, using a~     web-based educational tool with the additional result of increasing knowledge on pain~     neurophysiology and reducing fear-avoidance beliefs.~   "
7214|NCT02962804|"~     There are two primary aims in the study: 1) to determine the tolerability and feasibility of~     combination hypofractionated radiation therapy and PD-1 inhibition with nivolumab, and 2) to~     determine the ability of hypofractionated radiation therapy to enhance response rate from~     PD-1 inhibition versus PD-1 inhibition alone by comparing the observed response rate under~     the combination therapy with a previously reported response rate under inhibition alone.~   "
7215|NCT02962791|"~     Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients~     with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT,~     a lack of response is observed for about 25-30% of them whatever the response criteria used~     either based on the clinical status (NYHA class, Packer clinical composite score) or on~     ventricular remodeling parameters assessed by echography (Left ventricle end of systole~     volume). This rate has remained remarkably stable since the therapy started and has~     motivated many studies to better understand the underlying physiopathology and the CRT~     action mechanisms.~      Among the various research axes to improve CRT response and responders rate, increasing the~     number of pacing sites in an attempt to better homogenize the cardiac mechanical activity~     has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in~     three studies. In all cases, it demonstrated a significant improvement of cardiac~     performance whether assessed by echographic parameters or LV dp/dt measurements.~     Additionally feasibility of this approach for long term CRT delivery was demonstrated during~     a previous study. First results with triple-site ventricular stimulation are encouraging and~     its clinical efficacy should now be tested on a larger population in order to conclude on~     its interest for CRT candidates.~   "
7216|NCT02962778|"~     This study evaluates RAS peptides profiles in patients with treatment resistant arterial~     hypertension.~   "
7217|NCT02962765|"~     Prospective, multinational, non-interventional post-authorisation study to collect~     additional clinical data and to ensure consistency in the long-term between the outcome from~     pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients)~     and routine clinical practice. Besides aspects such as general product safety and efficacy,~     there will be a focus on immunogenicity, particularly on inhibitor development. The~     diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII~     inhibitor testing in the laboratory.~   "
7218|NCT02962752|"~     The current study uses a double-blind, placebo-controlled, randomised cross- over design to~     assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and~     blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.~   "
7219|NCT02962739|"~     Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide~     (F/TAF) works for treatment of chronic HIV, or prevention of HIV acquisition. Methods to~     measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar~     but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF.~     By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the~     study plans to see if these results predict adherence to taking the drug. The goal of this~     study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots~     (DBS) change in a predictable way. This study will mimic different levels of adherence (33%,~     67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the~     relationship between F-TAF in dried blood spots and adherence. Investigators will also~     measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.~   "
7220|NCT02962726|"~     The aim of this study is to evaluate the effect of starvation and recovery in adolescent~     anorexia nervosa patients in regard to microbiome activity and composition and to elucidate~     potential connections between weight gain, depression and other comorbidities, further to~     capture hormone levels and inflammation parameters in a longitudinal design.~   "
7221|NCT02962713|"~     Although the Atraumatic Restorative Treatment (ART) is well settled in the literature~     regarding occlusal-proximal cavities, the longevity of these restorations is still lower~     when compared to occlusal ones. This factor is often associated with low mechanical~     properties of glass ionomer cements (GIC). The objective of this randomized clinical trial~     is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated~     GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as~     restoratives materials in occlusal-proximal ART restorations of primary molars. Children~     aged between 4 and 6 years, will be selected in schools in the city of Barueri, São Paulo.~     All restorations will be held following the precepts of the ART and the manufacturer's~     instructions. The restorations will be evaluated after 1, 6, 12 and 24 months according to~     Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used~     Kaplan-Meier survival analysis and log rank test. To evaluate the association between the~     clinical variables, Cox regression test will be applied. For the cost analysis will be used~     analysis of variance. The level of significance for all tests will be considered to 5%.~   "
7222|NCT02962700|"~     The aim of the study was to investigate whether CVVH, in comparison to intermittent~     haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied~     by muscle microdialysis~   "
7223|NCT02962687|"~     The purpose of this study is to examine the feasibility and acceptability of a 12-week care~     management program for medically complex Veterans with cognitive impairment, delivered via~     telephone or videoconferencing.~   "
7227|NCT02962635|"~     A precise volume status assessment is critical to improve outcome of patients on dialysis.~     Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed~     by clinical evaluation and regular weight measurements before and after dialysis, which is~     not always accurate. Moreover, bioimpedance technology is used in some centers for~     quantitative assessment of total body water. This approach has been validated for the~     assessment of volume status in dialysis patients, but requires the acquisition of specific~     tools and is time consuming. So far, no biomarker has been validated to quantify volume~     status in dialysis patients. Application of biomarkers might contribute to a better dialysis~     prescription and therefore to outcome improvement in dialysis. The investigators aim to~     investigate the role of a novel biomarkers (sCD146) to assess volume status in dialysis~     patients~   "
7228|NCT02962622|"~     The study evaluates the association between soluble insulin receptor dysfunction,~     cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who~     volunteer to participate in the study will have two evaluations at study entry that include~     a dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing,~     blood and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA~     will be conducted in the Endocrinology Unit at the University Hospital, Medical Center~     (letter of support included). The cardiorespiratory fitness testing will be conducted in the~     AIDS Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences~     Campus, and the Puerto Rico Clinical and Translational Research Consortium. Then,~     participants will be invited to participate in a 6-week, 3 days/week individualized exercise~     program. The exercise program will be conducted at the University of Puerto Rico Medical~     Sciences Campus. After completion of the exercise program, study entry evaluations will be~     repeated. The duration of the study will take approximately 10 weeks.~   "
7229|NCT02962609|"~     The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and~     Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants~     upon their physiological characteristics and feeding performances.~   "
7230|NCT02962596|"~     This research is targeting patients with sonographically indeterminate adnexal mass that are~     being referred for clinical MR imaging. Investigators from the UW will be contributing coded~     MR images and associated health information (US results, laboratory/pathology results) to~     the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the~     research.~   "
7231|NCT02962583|"~     Limited interventional human studies suggest that probiotic supplementation may be a~     beneficial strategy for promoting weight loss when added to a nutritional intervention via~     their effects on lipid absorption and metabolic signaling molecules. The purpose of this~     study is to evaluate the effects of addition of a probiotic supplementation to a weight loss~     intervention on body weight, body composition and overall health in overweight adults.~   "
7232|NCT02962570|"~     The main goal of this study is to determine if supplemental oxygen given only when the~     patient is inspiring (demand delivery) is more effective than constant-flow oxygen given~     during all phases of the breath regardless if the patient is breathing it in. A previous~     study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the~     concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given~     in demand (inhalation only) mode. A secondary goal is to determine in patients, whether~     turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon~     Dioxide) monitoring. This was found to be the case in the previous volunteer study.~      The investigators want to determine if these improvements are also observable in relatively~     healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand~     mode will be determined by measuring the resulting difference in oxygen saturation and~     end-tidal oxygen levels. The investigators will alternate between traditional oxygen~     delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes~     in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal~     CO2 measurement will be compared with those during the brief time when O2 flow is stopped.~   "
7233|NCT02962557|"~     This study will explore the feasibility of an idea to use standard, FDA-approved patient~     monitors to detect ventilatory depression and then play a recorded nurse's voice to prompt~     patients by name to breathe. The voice prompt will occur in addition to when the traditional~     alarms are sounded by the monitors. The study device consists of commercially available~     physiologic monitors, a speaker, and a laptop computer. The physiologic monitors include a~     pulse oximeter with a motion sensor, capnometer, and nasal airway pressure sensor (built~     into a nasal cannula). Nasal pressure is a commonly used clinical monitor for sleep apnea~     detection during polysomnography testing in sleep labs.~   "
7234|NCT02962544|"~     Aim of the work is to compare the results of femtosecond assisted LASIK and small incision~     lenticule extraction (SMILE) as regards safety, efficacy and predictability. As a secondary~     outcomes , the investigators will compare the results of both techniques on corneal~     biomechanics, dry eye measures, corneal asphericity and higher order aberration.~   "
7235|NCT02962531|"~     An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01~     in 12 healthy male subjects. In each period, subjects will receive a single oral dose of~     1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed~     or fasted state~   "
7236|NCT02962518|"~     Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the~     ear may occur after helix piercings and are difficult to treat, since they tend to form~     recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high~     and prospective randomized trials are still missing.~      To unravel the most effective combination of therapeutic options for keloids of the ear, 20~     patients will be enrolled in a prospective, randomized trial. Patients either undergo~     surgery using the fillet technique and intra-lesional injections of triamcinolone 10mg /ml~     every 4 to 6 weeks for 6 months, or they are additionally treated with a non-customized~     pressure device.~   "
7237|NCT02962505|"~     The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the~     potential to optimize the ventilator therapy, validate the effectiveness, efficacy and~     safety of nursing and medical interventions (endotracheal suctioning, posture changes,~     surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications~     like pneumothorax and endotracheal tube misplacement. The study design is purely~     observational.~   "
7238|NCT02962492|"~     The study investigations include evaluation of the acute effects of a single dose of~     dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or~     placebo under insulinopenic condition and the long term effect under basal conditions before~     and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination~     of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and~     lipolysis.~   "
7239|NCT02962479|"~     This study aims to compare biological communities in stool samples obtained from age, diet~     and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS)~     never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing~     spondylitis previously or currently treated with TNF inhibitors, subjects with~     non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor~     (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or~     currently treated with TNF inhibitors and healthy participants.~      The differences in fecal microbiota composition will be explored using shotgun metagenomic~     sequencing through the University of Washington. The investigators predict that this study~     will confirm a significant difference between the fecal microbiota composition (FMC) of both~     AS and nrSpA patients and controls.~   "
7240|NCT02962466|"~     Performing an additional non invasive oocyte diagnostic test based on cumulus gene~     expression could improve the outcome of the ART cycle.~   "
7241|NCT02962453|"~     The aim of this study is to determine the clinical efficacy of gait rehabilitation robot~     through cortico-spinal-muscular pathway activation of the muscles remotely located from the~     end-effecter in patients after total knee arthroplasty.~   "
7242|NCT02962440|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,~     metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male~     subjects.~   "
7243|NCT02962427|"~     The purpose of this research study is to compare the effectiveness of a sphenopalatine~     ganglion block to an epidural blood patch for post-dural puncture headache relief in~     randomized postpartum parturients over a 48 hour period.~   "
7244|NCT02962414|"~     The purpose of this study is to evaluate the long-term safety in patients with TSC and~     refractory seizures who are currently receiving everolimus treatment in the~     Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued~     treatment as judged by the investigator at the completion of EXIST-3~   "
7245|NCT02962401|"~     Prospective national multicenter open label phase II Remodel WM3 trial~   "
7246|NCT02962388|"~     Prospective national multicenter randomized open label phase IIb RUXBETA trial.~   "
7247|NCT02962375|"~     Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber~     compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose~     area under the curve.~      Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber~     compared to a 100% orange juice will reduce 2 hr insulin iAUC response.~   "
7248|NCT02962362|"~     The purpose of this study is to collect patient outcomes data for patients who are~     undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided~     Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida,~     USA). Patient outcomes data are important for assessing the post-market safety and~     effectiveness of orthopedic medical devices.~   "
7249|NCT02962336|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,~     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of~     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22~     days.~   "
7250|NCT02962323|"~     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium~     Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing~     periods of studies were separated by a washout period of 7 days.~   "
7251|NCT02962310|"~     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium~     Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing~     periods of studies were separated by a washout period of 7 days.~   "
7252|NCT02962297|"~     VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to~     evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults~     with NASH compared to treatment with placebo in China.~   "
7253|NCT02962284|"~     This is an open-label, single-arm, multi-center extension study to evaluate safety in~     patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).~     Patients will have successfully completed an 84-day treatment with abiraterone acetate in a~     previous trial. Results from the final visit of the previous study will be used to determine~     patient's eligibility for this study. Patients in this study will be eligible to receive~     open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of~     serum testosterone and PSA levels will be monitored. Disease progression will be assessed by~     PCWG2 criteria.~   "
7254|NCT02962271|"~     Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked~     with rash of psoriasis, but there's still great controversy regarding the exact relationship~     between them. Our study is to investigate the characteristics and differences of the~     ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to~     explore the risk factors of Ps developing into PsA in the long term course.~   "
7255|NCT02962258|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,~     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of~     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22~     days.~   "
7256|NCT02962245|"~     The research aim to find out whether berberine can reduce the annual recurrence rate of~     ulcerative colitis in remission.~      A total of 238 patients with ulcerative colitis in remission will be randomly divided into~     two groups.One will receive regular treatment,and the other group will receive extra oral~     berberine 300 mg three times daily for a year.~      The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points~     or more ).~      The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease~     activity index scores at the baseline and final assessments.~   "
27884|NCT02692170|"~     A single center, randomized, double blinded phase I/IIa exploratory study to evaluate~     reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in~     human adult~   "
7259|NCT02962206|"~     Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency~     department before casting. Standard of care currently requires that x-rays be performed~     before and after fracture reduction, and inadequate reductions may be subject to repeat~     attempts and are at a higher risk to require surgery. This study will assess the use of~     point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the~     angulation at the fracture site after a reduction is performed. If this angulation is~     decreased, it would suggest that POCUS for distal radius fracture reduction could decrease~     the number of failed reduction attempts and therefore the number of repeated reduction~     attempts.~   "
7260|NCT02962193|"~     After bariatric surgery there are big changes in the daily functions, activities and social~     participation of the patients.~      This is a prospective study that examine daily performance and daily participation by~     questionnaires, before and after bariatric surgery.~   "
7261|NCT02962180|"~     Actually the methods for melanocyte delivery are invasive and often sophisticated. The~     dermarolling system with needles causing tiny microinjuries in the epidermis could offer a~     minimally invasive and painless method of melanocyte transplantation. The purpose of the~     study is to develop a new and simple method for transepidermally delivering keratinocytes~     and melanocytes into vitiligo skin.~   "
7262|NCT02962167|"~     This is a two arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      This study will look to determine the safety and recommended phase 2 dose of the modified~     measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or~     atypical teratoid rhabdoid tumor (ATRT).~   "
7263|NCT02962154|"~     The purpose of project is to answer fundamental questions about the mechanisms underlying~     mental stress ischemia in patients with coronary artery disease, mood disorders, or both,~     and to identify potential biomarkers and psychosocial risk factors associated with this~     condition.~      To achieve this goal, investigators will use cutting-edge cardiovascular and functional~     neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory~     setting in subjects recruited from four patient populations: 1) patients who recently~     sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary~     angiography (with and without known coronary artery disease); 3) patients with a diagnosis~     of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2~     disorder.~   "
7264|NCT02962141|"~     To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon~     Dilatation Catheter (APERTO OTW) compared with the Balloon Dilatation catheter (OHICHO II)~     for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.~   "
7265|NCT02962128|"~     A randomized, clinical trial to provide the first comprehensive investigation of the role of~     fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as~     well as levels of inflammatory markers in a controlled dietary environment using two (low~     and high linoleic acid) parallel diets.~   "
7266|NCT02962115|"~     This study evaluates the feasibility of a clinical informatics system-based approach to lung~     cancer screening. Patients of a large academic medical center who may qualify for lung~     cancer screening will be sent an electronic invitation to complete an online lung cancer~     screening decision aid.~   "
7267|NCT02962102|"~     The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and~     calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney~     injury (AKI) in critically ill patients.~   "
7268|NCT02962089|"~     Oral supplementation with branched chain amino acids (BCAA) increases the levels of~     circulating BCAA, stimulates BCAA uptake in muscles, and decreases amino acid release from~     muscle, eventually promoting muscle anabolism. However, uptake of oral BCAA by muscle is not~     complete, pointing out that non-muscular tissues, as the splanchnic bed and gut microbiota,~     may play a role in BCAA metabolism.~      This protocol aims at studying the impact of protein-energy wasting (PEW) and of refeeding~     with branched chain amino acids (BCAA), on gut barrier including gut microbiota, in chronic~     hemodialysis (HD) patients. The investigators speculate that:~        1. HD patients with PEW have altered composition and function of gut microbiota, increased~          permeability of epithelial gut barrier, increased systemic inflammation but decreased~          fecal immunoglobulin A (IgA), and a dysbalance of plasma appetite mediators in favor of~          anorexigenic mediators, compared to HD patients without PEW, non dialyzed patients with~          chronic kidney disease and well-nourished non obese subjects,~        2. BCAA supplementation of HD patients with PEW reverses these changes, thereby improving~          nutritional state, physical function, quality of life and resistance to infections.~   "
7269|NCT02962076|"~     Imaging is to be performed prior to procedure using positron emission tomography/ computed~     tomography (PET/CT), after a special dye is injected. The scans are going to be merged with~     other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.~   "
7270|NCT02962063|"~     The purpose of this study is to test the safety of adding a new drug, durvalumab (also~     called MEDI4736), to chemoradiation using two standard chemotherapy drugs, carboplatin and~     paclitaxel. The investigators want to find out what effects, good and/or bad, this~     combination has on the patient and cancer.~   "
7271|NCT02962050|"~     Individuals with Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment~     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and~     aspiration pneumonia. These sequelae necessitate timely identification of at risk~     individuals to ensure optimal management of oral intake and pulmonary function. The purpose~     of this study is to evaluate the discriminant ability of several non-invasive screening~     tools at detecting swallowing impairment in individuals with ALS.~   "
7272|NCT02962037|"~     The purpose of this study is to determine whether the known treatment for DSPS also improve~     the cognitive ability and mood of the patients.~   "
7273|NCT02962024|"~     the investigators aim is to investigate and explore the effect 10 mg morphine added to local~     anesthetics in serratus anterior plane block for post mastectomy pain management after~     modified radical mastectomy in patients with breast cancer with assessment of its serum~     level if it will be absorbed systemically or not?~   "
8481|NCT02945163|"~     Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral~     therapy in developing countries. Based on our previous data, we aim to evaluate whether~     reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side~     effects while not scarifying their virological efficacy.~   "
7274|NCT02962011|"~     This was an unblinded randomized controlled trial. Women were randomized to uterine closure~     with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of~     elective cesarean. The primary outcome was closure time of the uterine incision. Also~     measured were blood loss during incision closure and the use of additional hemostatic~     sutures. Informed consent was obtained~   "
7275|NCT02961998|"~     Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the~     popularity of health examination, most patients were diagnosed as HCC in advanced stages so~     far. Sorafenib is currently recognized worldwide as the only effective treatment for~     advanced HCC. However, sorafenib need long-term medication, and will bring a series of side~     effects, including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs~     swelling, rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously~     affect patient's quality of life.Besides, this side effects appeared to be dose-related.When~     severe HFS happened, sorafenib need to reduce dosage or discontinue administration, which~     could seriously affect the patient's survival. Therefore, investigators designed this~     prospective randomized controlled study to explore preventive effect of celecoxib for~     sorafenib related HFS, the influence on the quality of life in patients with, and also the~     synergistic anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study~     will explore horizon of improving treatment for sorafenib in patients with advanced~     HCC,quality of life and tumor control.~   "
7276|NCT02961985|"~     The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the~     treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to~     provide current data on the implementation of guidelines for both, the interventional and~     adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.~   "
7277|NCT02961972|"~     The present study aims at investigating the effects of the oral supplementation with~     creatine on the systemic microvascular reactivity and plasma levels of homocysteine in~     vegetarian individuals of the vegan type.~   "
7278|NCT02961959|"~     Background: Pelvic pain is common during pregnancy and usually subsides after delivery. Some~     women, however, experience severe and long-standing pelvic pain, judged to emanate from the~     Sacro-iliac joints (SI-joints). Radiological correlates are absent and there are diverging~     opinions regarding the value of different clinical testing procedures and the use of~     anaesthetic blocks to reveal SI-joint origin of the pain. In case of slight or moderate pain~     the situation may be solved by the use of analgetics and physical therapy, but in case of~     severe pain the situation might end up in a discussion whether surgery with arthrodesis of~     the SI joint might be of value. To our knowledge, however, the results from surgical~     treatment has not been compared with non-surgical treatment in a randomized study.~      Aim: The investigators´ hypothesis is that~        1. there exists a specific identifiable subgroup of patients within the chronic low back~          pain (CLBP) group in whom the pain emanates from the sacro-iliac (SI) joints, and that~        2. patients in this subgroup may be selected based on thorough symptom analysis, and~        3. that arthrodesis of the actual joint/s may reduce the pelvic pain. Methods: A RCT with~          parallel group design with pre- and post-treatment data. Inclusion of women 18-55 years~          old with pronounced pelvic pain for at least 2 years and having tried ordinary physical~          therapy without improvement and being on sick leave at least 50 percent. Operation by~          posterior approach with bone transplantation between the iliac bone and the sacrum,~          using microsurgical technique. Patients in both groups, the surgical (S) and~          non-surgical (NS) were all treated by formal physiotherapy at a five days stay at the~          Clinic and instructed to continue their training at home according to the lines given~          at the Clinic.~      Outcome: The primary outcome was perceived pelvic pain according to the assessments on the~     validated Balanced Inventory for Spinal Disorders questionnaire (BIS) and on a Visual~     Analogue Scale (VAS) before treatment and at follow-up one year after treatment. The~     perceived change in pain was also assessed on a transitional scale in the follow-up version~     of the BIS.~      Secondary patient reported outcome measures (PROM) were pain related functions assessed on~     the Oswestry Disability Index questionnaire (ODI), the BIS and the Roland-Morris~     questionnaire. Health related quality of life was assessed by using the Short-Form 36~     (SF-36) and Euro-Quol (EQ-5D) questionnaires.~   "
7279|NCT02961946|"~     To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal~     administration of Nitroglycerin. Aim of this prospective research study is to investigate~     equivalence on image quality after sublingual or transdermal Nitroglycerin administration~     (H0).~      Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.~   "
7280|NCT02961933|"~     This study will determine rates of first pass success without hypoxemia in emergency~     department intubations with and without the use of apneic oxygenation by nasal cannula.~   "
7281|NCT02961920|"~     The area of aesthesia-induced atelectasis is much larger in the obese compared with the~     non-obese, but there may also be more airway closure and impaired matching of ventilation~     and lung blood flow.~      When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn)~     decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the~     abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is~     designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall~     and therefore does not allow the abdomen to hang completely, especially in obese patients.~      This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study~     aimed to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the~     conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery~     in the prone position in obese patients.~      We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation~     without hemodynamic instability .~   "
7282|NCT02961907|"~     Infertility is defined as the inability to conceive after 12 months of unprotected~     intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors~     of the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco,~     coffee, drugs, exercise, stress, sleep, pollution...) are risk factors for infertility.~     Weight gain, in both members of the couple, is associated with an increased risk of Assisted~     Reproduction Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle~     makes the risk of infertility three times less likely to happen. Idiopathic infertility may~     greatly benefit from lifestyle factors optimization.~   "
7283|NCT02961881|"~     Primary Objective:~      • To evaluate the safety and tolerability of every 12 hours (q12h) and every 24 hours (q24h)~     administration of subcutaneous (SC) blinatumomab~      Secondary Objectives:~        -  To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC~          administrations~        -  To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered~          subcutaneously~        -  To determine the incidence of anti-blinatumomab antibody formation following SC~          administration~        -  To evaluate efficacy response following treatment with SC blinatumomab administration~      Exploratory Objective:~        -  To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as~          cytokine profiles during SC administration~        -  To evaluate efficacy response following treatment with SC blinatumomab administration~          using Lugano criteria~   "
7287|NCT02961829|"~     It is becoming clear that a combination of interventions will be desirable to achieve HIV~     cure. Therefore the investigators propose a pilot proof of concept study, using combination~     of a number of different interventions for eradicating residual plasma viremia and~     decreasing HIV reservoirs. The investigators hypothesize that, (i) antiretroviral~     intensification using Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination~     using autologous HIV, and (iii) purging intervention using the Class III HDACs, Sirtuin-1,~     and (iv) decreasing the ratio of long-lived central memory (TCM)/transitional memory (TTM)~     CD4+ T-cells using Auranofin will provide a synergistic impact leading to a sterilizing cure~     of HIV infection. Results of this study may provide insightful evidence for planning the~     next steps using the more efficacious combination of intervention strategies towards HIV~     sterilizing cure.~   "
7288|NCT02961816|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or~     without rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are~     receiving a stem cell transplant.~   "
7289|NCT02961803|"~     The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day~     over placebo in the clinical improvement (walking tests) of patients with~     adrenomyeloneuropathy~   "
7290|NCT02961790|"~     This randomized phase III trial studies how well oxybutynin chloride works in managing hot~     flashes in patients who are not candidates for, or not interested in hormone replacement~     therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes,~     however doses used in prior studies have resulted in side effects. This trial is evaluating~     lower doses of oxybutynin with the goal of determining if they are efficacious with less~     side effects.~   "
7291|NCT02961777|"~     Cardiovascular diseases, and more precisely patients with ST - elevated myocardial~     infarction are globally responsible for a large number of hospitalizations and deaths.~     Monitoring the quality of care for these patients is very relevant topic. Investigators~     developed indicators from the scientific literature on the quality of care for patients with~     STEMI at both the patient level and hospital level. The indicators were subsequently~     validated by a RAND modified Delphi - study of multidisciplinary experts in the care of~     patients with STEMI.~      In this study, the following objectives are set:~        1. ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with~          cardiology department by retrospective and prospective audit of 20 patient records per~          participating hospital .~        2. ) Study of the interdisciplinary relationships and communication within teams involved~          in the care of patients with STEMI in the participating hospitals 3) Study of perceived~          organization of care for patients with STEMI in the participating hospitals~      In accordance with the objectives of the research, the study consists of three phases:~        1. ) A retrospective observational audit of 20 patient records of patients with STEMI each~          participating hospital.~        2. ) A prospective observational audit of 20 patient records of patients with STEMI each~          participating hospital.~        3. ) A survey using validated instruments of interdisciplinary relationships and~          communication on the one hand and on the other by the teams involved in the care of~          patients with STEMI perceived organization of care .~      Data collection is performed by local researchers and remains their property. The data is~     coded and kept confidential. Only the local researcher has access to the encryption key. The~     data are protected by the Belgian law on privacy and medical confidentiality, only to be~     used in the context of this study. The results are published anonymously.~   "
7292|NCT02961764|"~     This study will evaluate a new critical pathway (use of guideline-based patient~     identification criteria and for those who meet these criteria, use of dalbavancin) for the~     treatment of ABSSSI compared to usual care.~   "
7293|NCT02961751|"~     Data from this clinical study will be used to assess if the treatment approach meets CDC~     criteria for becoming a recommended treatment (cure rate greater than 95 percent with a~     lower CI:95percent greater than 95 percent) or alternative treatment (cure rate greater than~     95 percent with a lower CI95 percent greater than 90 percent) for uncomplicated gonococcal~     infection. An estimated cure rate of 0.98. A single-arm clinical study design, allowing for~     a 10 percent subject drop-out rate and 10 percent non-evaluable rate. Screening Visit will~     include a NG NAAT; the Baseline Visit at Day 1 will include a NG NAAT and culture; Test of~     Cure Visit at Day 6 will include a NG NAAT and culture. The primary objective of this study~     is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae~     infections with gyrA serine 91 genotype.~   "
7294|NCT02961738|"~     Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT)~     which is assumed to increase engagement and improve outcomes. This trial sought to test~     these claims. A randomized and controlled dismantling trial method has been designed to~     investigate treatments outcomes for depressed patients receiving CAT in an Improving Access~     to Psychological Therapies service. Participants will be randomized to either treatment as~     usual (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure~     is the Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety,~     functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every~     treatment session and at 8-weeks follow-up. The trial will enable as assessment of the~     utility of NR during CAT. and whether CAT appears suitable for treating depression in~     Primary Care.~   "
7295|NCT02961725|"~     Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and~     another part of the body, may develop when there are penetrating wounds of the thorax and~     after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high~     rate of mortality and teratogenicity.~      The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells~     to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to~     investigate the application of umbilical cord mesenchymal stem cells in the treatment of~     bronchopleural fistula.~   "
7296|NCT02961712|"~     HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus~     called human T lymphotropic virus type 1（HTLV−1）. Natural Killer cells provide rapid~     responses to viral-infected cells, acting at around 3 days after infection, and respond to~     tumor formation. In this trial, the investigators aim to study the therapeutic safety and~     the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the~     disease and should lead to better therapy.~   "
7362|NCT02960932|"~     Muscles, paretics and spastics, of cerebral palsy children have very early, for growth~     (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often~     reaches on the cerebral palsy, characterised by a modification of the structure (volume~     decrease) and the elasticity (increase of the passive stiffness). Every alterations of the~     muscular property have impact clinic and functional important. The many treatments of~     orthopaedic targeting (lengthening of cast, injections of botulinic toxin), repeated to a~     multiple recovery during the growth influences the muscular characteristics. There is a real~     interest to measure the muscular property development during children's growth.~   "
8482|NCT02945150|"~     Proof of concept, open-label single center study for the donation of HCV positive kidneys to~     HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission~     upon transplantation.~   "
7297|NCT02960659|"~     Background:~      The pill metformin treats diabetes. But it does not work for all youth, especially~     African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers~     want to understand how these drugs work and if they decrease excess sugar made by the liver~     in youth with type 2 diabetes.~      Objective:~      To test if using liraglutide and metformin are better than just metformin for decreasing~     excess sugar produced by the liver in African-American youth with type 2 diabetes.~      Eligibility:~      African-Americans ages 12 21 with type 2 diabetes~      Design:~      Visit 1: Participants will be screened with medical history, physical exam, and blood and~     urine tests.~      Participants will stop taking diabetes medicines for 1 week. They will learn how to check~     blood sugars at home twice a day.~      Visit 2: Overnight at the clinic. Participants will have:~      Vital signs taken.~      Pregnancy test.~      A thin plastic tube (IV catheter) be inserted in each forearm by needle.~      Blood drawn several times after drinking a sweet drink.~      X-ray of total body fat.~      Urine and stool collected.~      Breath tests while wearing a clear hood for up to 45 minutes.~      For several hours, participants can have only water. At 4 a.m. they will get sugar and fat~     with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9~     a.m. to 2 p.m., they will drink small amounts of a shake and have blood drawn.~      Participants will be randomly assigned to take either both study drugs daily or just~     metformin daily.~      Visits 3 4: Participants will bring their blood sugar records and have blood tests.~      Visit 5, after 3 months: Repeat of visit 2....~   "
7298|NCT02960646|"~     The goal of this clinical research study is to learn if giving a modified stem cell~     transplant is less likely to cause graft-versus-host disease (GVHD) to patients with certain~     types of blood disorders or blood cancers make patients less likely to develop GVHD.~     Participants will also receive melphalan and fludarabine as part of their regular~     chemotherapy and total body irradiation (TBI) regimen.~      Before participant receives the stem cell transplant, it will be modified to remove~     certain types of T cells that cause GVHD.~      GVHD occurs when transplanted immune tissue, such as T cells and stem cells, attacks the~     tissues of the recipient's body.~   "
7299|NCT02959645|"~     To address joint position sense in cervical dystonia patients and how it affects the brain~     activity.~   "
7300|NCT02959632|"~     The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted~     Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of~     hospitalized patients.~   "
7301|NCT02959619|"~     This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK~     inhibitor in Chinese patients with ALK-positive non-small cell lung cancer~   "
7302|NCT02959606|"~     After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet~     therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent~     occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced~     as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the~     efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent~     EVT for femoro-popliteal occlusive disease.~   "
7303|NCT02959593|"~     To determine the relationship between the affects of viewing commercially available content~     through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy~     subjects.~   "
7304|NCT02961686|"~     The trial is to describe quality of life in patients affected by prostate cancer treated~     with exclusive radiotherapy and submitted to psychological and andrologic evaluation.~   "
7305|NCT02961673|"~     A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in~     Subject with Moderate to Severe Glabellar Lines~   "
7306|NCT02961660|"~     The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral~     dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK~     in matched participants with normal renal function.~   "
7307|NCT02961647|"~     The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair.~     Optimally this should be timed so late that it commensurate with the risk of surgery and~     before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an~     understanding of the differences between the symptomatic and asymptomatic patient.~      The study will test~      A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke~     work during physical strain compared with asymptomatic MR.~      B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1~     year after mitral valve repair.~      C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40~     patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with~     simultaneous echocardiography and invasive measurement of central hemodynamics. In addition~     a pulmonary function test and cardiac MRI will be performed.~   "
7308|NCT02961634|"~     Single-center study, single blind, comparative with the objective of evaluating the efficacy~     and safety of an investigational product as an adjunct in the treatment of onychomycosis~     improvement of 90 days ± 2 days.~   "
7309|NCT02961621|"~     Emergency call centers across the country are preparing for the Next Generation 911 (NG911)~     initiative, which will allow citizens to place 9-1-1 calls using digital technologies such~     as text messaging, email, Skype or instant messaging, and will expand emergency information~     sources to also include streaming video, photo uploads, and automatic crash notifications.~     The impact of these new information and communication technologies on those tasked with~     using them in time-sensitive emergency situations is unknown. Our study is designed to~     address the following hypotheses: 1) We hypothesize that NG911 implementation will have a~     significant effect on telecommunicator stress levels and 2) A resiliency training tailored~     to the needs of telecommunicators will mitigate the impact on NG911 implementation on stress~     levels. We will test these hypotheses through the following specific aims:~      Aim 1: Measure levels of stress, job satisfaction and job performance among 9-1-1~     telecommunicators before and after the NG911 implementation.~      Aim 2: Develop and test the efficacy of an evidence-based resiliency training and worker~     support intervention to improve psychological well-being and job performance of 9-1-1~     telecommunicators.~      Aim 3: Build an ABM tool of 9-1-1 call centers to improve 9-1-1 telecommunicator workforce~     training and smooth transitions to future call center innovations.~   "
11985|NCT02900560|"~     The purpose of the study is to determine the optimal dose of CC-486 (oral azacitidine) in~     combination with pembrolizumab for the treatment of platinum-resistant/refractory Epithelial~     Ovarian Cancer (EOC).~   "
7310|NCT02961608|"~     LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing.~     Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules~     and no new safety concerns.~        -  Stable kidney transplant patients can be safely converted from Adoport® twice-daily to~          LCP-Tacro®.~        -  The greater bioavailability of LCP-Tacro after once-daily dosing results in similar~          (AUC) exposure, at a dose approximately 30% less, than the total daily dose of~          Adoport®.~        -  LCP-Tacro provides a slow drug release and this results in flatter kinetics~          characterized by significantly lower peak-trough fluctuations.~        -  CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A~          (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on~          their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12~          for tacrolimus.~        -  CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not~          correlate with an increase in the CN activity.~   "
7311|NCT02961595|"~     Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending~     on the age of infection and the type of enterovirus in question. This study evaluated~     whether early serial exposures to three replication-competent enterovirus strains (live~     poliovirus vaccine, OPV) can influence the immunity to other enteroviruses and the possible~     initiation of autoantibodies e.g. islet autoimmunity in young genetically predisposed~     children.~   "
7312|NCT02961582|"~     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral~     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)~     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and~     cost-effectiveness in this patient group.~      Objective: The main objective of this study is to assess the effectiveness of SNM compared~     to personalized conservative treatment (PCT), in patients with idiopathic slow-transit~     constipation who are refractory to conservative treatment. The secondary objectives are~     assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT.~      Hypothesis: Based on previous research we hypothesize that SNM will be more effective than~     PCT in terms of a significantly higher proportion of patients having treatment success at 6~     months.~      Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a~     prospective cohort study.~      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic~     slow-transit constipation refractory to conservative treatment.~      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of~     two phases. In the screening phase an electrode is inserted near the third sacral nerve and~     connected to an external stimulator. If the screening phase is successful (average~     defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is~     implanted in the buttocks of the patient. If not successful, patients receive conservative~     treatment. The control intervention is PCT. This is the best and least invasive alternative~     to SNM. PCT consists of medication and/or retrograde colonic irrigation.~      Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an~     average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are~     straining, sense of incomplete evacuation, constipation severity, fatigue, constipation~     specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months.~     Furthermore, cost-effectiveness and budget-impact will be estimated.~   "
7313|NCT02961569|"~     Tuberculosis (TB) is a major cause of death among the communicable diseases in the world.~     Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier~     diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim~     of the study will be to compare two strategies, in patients with a chest-X-ray in favour of~     contagious pulmonary TB: the classical strategy of sputa collection during three consecutive~     early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour~     h+2 during the first early morning.~   "
7314|NCT02961556|"~     This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of~     AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation.~     The safety and efficacy of 12 weeks of administration will also be evaluated.~   "
7315|NCT02961543|"~     A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be~     conducted.~      Participants will be randomized into: Group I, submitted to a muscular rehabilitation~     program based on eccentric isokinetic exercise; and Group II, submitted to a muscular~     rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular~     rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with~     analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle~     rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 45~     days after ACL reconstruction. The programs will last six weeks, with training frequency of~     two sessions per week, separated by a minimum interval of 72 hours.~   "
7316|NCT02961530|"~     A randomized clinical trial involving 32 individuals submitted to partial menisectomy will~     be conducted.~      Participants will be randomized into: Group I, submitted to a muscular rehabilitation~     program based on eccentric isokinetic exercise; and Group II, submitted to a muscular~     rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular~     rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with~     analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle~     rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15~     days after partial menisectomy. The programs will last six weeks, with training frequency of~     two sessions per week, separated by a minimum interval of 72 hours.~   "
7317|NCT02961517|"~     Questionnaire study to investigate the effect of individual characteristics such as age,~     sex, ethnicity, educational level and socioeconomic status on the preferred format of~     patient education delivery, for patients with diabetes and/or cardiovascular disease~   "
7318|NCT02961504|"~     The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional~     outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in~     subjects with acute ischemic stroke.~   "
7319|NCT02961491|"~     The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane~     I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with~     iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).~   "
7320|NCT02961478|"~     IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated~     by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure~     episode.~   "
7363|NCT02960919|"~     This is a prospective observational study assessing the clinical outcomes of children 2 to~     59 months of age with both pneumonia and other co-morbidities presenting to a tertiary~     hospital outpatient setting in Malawi, Africa who are most at risk for mortality or have~     other complications and thus, are typically excluded from childhood pneumonia studies.~   "
7364|NCT02960906|"~     Disease and Stage: naïve metastatic kidney cancer.~      A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or~     VEGFR tKi in naïve metastatic Kidney cancer~   "
7321|NCT02961465|"~     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral~     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)~     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and~     cost-effectiveness in this patient group.~      Study design: A prospective cohort study with one group. This study is conducted next to a~     randomized controlled clinical trial (RCT) on 'the effectiveness and cost-effectiveness of~     sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to~     conservative treatments' (for more information ClinicalTrial.gov ID: NCT02961582). This RCT~     is part of a temporary reimbursement arrangement, called conditional reimbursement of health~     care (in Dutch: Voorwaardelijke Toelating) of the National Health Care Institute~     (Zorginstituut Nederland). As part of this arrangement, the Ministry of Health, Welfare and~     Sports requires that SNM remains available for eligible patients during the conditional~     reimbursement period, also when inclusion of the RCT has ended. Furthermore, the Ministry~     requires that patients who received personalized conservative treatment in the RCT (control~     group), are offered SNM after completion of their follow-up of 6 months. As a result, the~     National Health Care Institute requires that the patients who receive SNM outside the RCT~     are included in a prospective cohort study to be able to collect data on them.~      Aim: The aim of this prospective cohort study is to collect more (but uncontrolled)~     information regarding the safety and effectiveness of SNM.~      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic~     slow-transit constipation refractory to conservative treatment.~      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of~     two phases. In the screening phase an electrode is inserted near the third sacral nerve and~     connected to an external stimulator. If the screening phase is successful (average~     defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is~     implanted in the buttocks of the patient. If not successful, the pacemaker will be removed~     and patients receive conservative treatment.~      Main study parameters/endpoints: The primary outcome is treatment success at 6 months,~     defined as an average DF of ≥3 a week according to a 3-week defecation diary and safety.~     Secondary outcomes are straining, sense of incomplete evacuation, constipation severity and~     generic (health-related) quality of life ((HR)QOL).~   "
7322|NCT02961452|"~     Peanut allergy (PA) has been well studied and its prevalence was estimated up to 1.3% in~     Europe. Tree nut (TN) allergy and PA are clinically similar and often coexist, TN allergy~     prevalence ranged from 0.05 to 4.9 %. TN allergy is longlasting and nearly all TN have been~     associated with fatal allergic reactions . Other legumes or TN also contain seed storage~     protein orthologs of the globulins (Ara h1, Ara h 3) and 2S albumins (Ara h 2) of peanut,~     susceptible to provoke allergic reactions, but cross-reactivity to TN and other legumes in~     PA patients could also appear through primarily sensitization. These possible IgE-binding~     cross-reactions bring to recommend the avoidance of TN and other legumes which have never~     been eaten in PA children. In this context, diagnosis work-up of relevant cross-allergy~     versus asymptomatic cross-sensitization will impact directly children's health-related~     quality of life (HRQL).~      When physicians suspect food allergy, many parameters have to be considered, such as~     clinical background, clinical history, type of symptoms related to the suspected food and~     cross-allergy to other foods. Then, to objectively confirm a food allergy and to assess its~     severity (related to the threshold reactive dose and symptoms), an oral food challenge (OFC)~     is demanded, and double-blind placebo-controlled food challenge (DBPCFC) is considered as~     the gold standard.~      Although OFC are more and more available in the diagnosis of PA, the assessment of~     cross-allergy to every single allergenic TN and legumes requires full allergy work-up and~     often many years of follow-up. Few studies investigated cross-allergy to TN and other~     legume, with rates of cross-allergy to TN between 28% and 50%. However, targeting patients~     with severe or cross-allergic phenotypes would greatly assist the allergist in management~     and follow-up of PA patients (i.e., planning OFC to cross-reactive food).~      Our main objective is to identify different disease phenotypes of PA children with cluster~     analysis. This statistical approach has never been performed to identify cross-allergic~     phenotypes. We also will describe cross-allergy in PA and will identify possible risk~     factors for cross-allergy to TN and other legumes in PA children.~   "
7323|NCT02961439|"~     The use of echocardiography in intensive care is a developing field. In expert hands~     echocardiography has proven its utility in diagnosing cardiac pathology, differentiating~     shock states and in haemodynamic monitoring. However, whether the results obtained by~     experts can be generalized to trainees or specialists with limited training remains unclear.~     Further, concerns around training time and cost for intensive care staff have been a factor~     in limiting the uptake of echocardiography in intensive care.~      The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in~     training after completion of the current minimum training. After completing a structured~     teaching program and 30 mentored training scans trainees will be assessed on their accuracy~     with echocardiography. In the research phase trainees will complete a further 40 scans with~     each one matched with an expect scan. The results from the expert and trainee scans will be~     compared to determine the trainee's accuracy.~   "
7324|NCT02961426|"~     This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety,~     tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV~     infection.~   "
7325|NCT02961413|"~     This is a multi-center, prospective, non-interventional cohort study .~      Its primary objectives are:~        1. assess DILI patients' clinical characteristics, disease progression and influencing~          factors in clinical practice;~        2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities~          mode, etc.~   "
7326|NCT02961400|"~     A drop off in improvement over the months and years after treatment is common. One~     contributor may be poor memory for the contents of treatment. This study seeks to determine~     whether text messages containing reminders of the content of sessions will improve treatment~     outcomes.~   "
7327|NCT02961387|"~     Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which~     produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the~     patients with tracheal stenosis.~   "
7328|NCT02961374|"~     This phase II trial studies the side effects of erlotinib hydrochloride and how well it~     works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at~     risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
7329|NCT02961361|"~     Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through~     intravenous infusion，in order to improved the quality of block in regional anesthesia. In~     this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed~     with ropivacaine in coracoid approach brachial plexus block.~   "
7330|NCT02961348|"~     This study will compare early with late start of treatment with Non-vitamin K oral~     anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation;~     it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register~     (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset)~     while the other half will start late (5-10 days after stroke onset).~   "
7365|NCT02960893|"~     The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia~     symptoms in subjects with spinocerebellar ataxia (SCA).~   "
7366|NCT02960880|"~     The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban~     prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.~   "
7409|NCT02960282|"~     This research trial studies the gut microbiome in fecal samples from patients with cancer~     that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy.~     Studying samples of feces from patients with metastatic cancer in the laboratory may help~     doctors learn if the make-up of the gut microbiome has a positive or negative influence to a~     patient's response to chemotherapy or immunotherapy.~   "
7331|NCT02961335|"~     Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that~     affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis~     of DPLD is often challenging, because of the large number of pathological entities involved,~     which share close clinical and radiological presentations. High resolution Chest CT, a key~     diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations,~     so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling.~     This invasive procedure is not devoid of morbidity and may be impossible to perform in~     fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a~     multi-disciplinary expert consensus, based on careful medical history, chest CT and~     bronchoalveolar lavage examinations.~      Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic~     technique that allows distal lung microscopic imaging in vivo, during a flexible~     bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in~     a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and~     healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary~     acinus, and confirmed the safety of the technique.~   "
7332|NCT02961322|"~     This is a study of health economics longitudinal cohort on the evaluation of direct medical~     cost of a surgical technique based on the use of an innovative device (the da Vinci®~     surgical robot Si) and its comprehensive care.~   "
7333|NCT02961309|"~     The objective of the proposed research is to investigate how smoking increasing potency of~     THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking~     behavior, urges, subjective effects, and abuse liability. This study will be a~     within-subjects, placebo-controlled study in our clinical laboratory of the effect of active~     vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge,~     subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco~     cigarettes.~   "
7334|NCT02961296|"~     The purpose of this study is to make nationwide registry for antimicrobial resistance of~     Helicobacter pylori using single method with agar dilution in Korea.~   "
7335|NCT02961283|"~     The study is divided into two parts. The first part of the study will test various doses of~     ASN003 to find out the highest safe dose to test in three specific groups.~      The second part of the study will test how well ASN003 can control cancer. Subjects will be~     enrolled into one of three groups.~      Group 1: metastatic or recurrent melanoma with documented BRAFV600 mutation (n=20 evaluable~     patients) Group 2: metastatic colorectal cancer (CRC), or advanced non-small cell lung~     cancer (NSCLC) with documented BRAFV600 mutation (n=14 evaluable patients) Group 3: advanced~     solid tumors with documented PI3K pathway alterations (PIK3CA mutation or PTEN loss) (n=14~     evaluable patients)~   "
7336|NCT02961270|"~     This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in~     non-small cell lung cancer patients harboring uncommon EGFR mutation~   "
7337|NCT02961257|"~     The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or~     neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of~     cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 70 years) with~     mCRPC previously treated with a docetaxel-containing regimen.~   "
7338|NCT02961244|"~     Aim of this study is to investigate the efficiency of a standard normothermia protocol and~     effects on postoperative Surgical Site Infection (SSI) rate.~   "
7339|NCT02961231|"~     The cost of pneumococcal conjugate vaccine use can be greatly reduced by making use of~     existing herd immunity to protect children against vaccine type pneumococci. The~     investigators will reduce the circulation of vaccine type pneumococci to low levels by PCV~     catch-up campaign; vaccinating all children less than 3 years of age with PCV, after which~     the investigators will evaluate the ability of a simplified two doses regimen and an~     alternative one dose regimen to prevent the reintroduction of vaccine type pneumococci~     compared to the WHO recommended 2 doses schedule.~   "
7340|NCT02961218|"~     To determine the effect of canakinumab versus placebo on daily pain experienced by sickle~     cell anemia patients (Reduction of average daily pain VAS over the period of Week 8 to 12 as~     compared to baseline levels).~   "
7341|NCT02961205|"~     This randomized controlled pilot study evaluates the use of oral nutritional supplementation~     in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is~     given for 30 days prior to surgery, continuing throughout their surgical hospitalization and~     ends at hospital discharge. Half of the participants will receive the oral nutritional~     supplement and the other half will not.~   "
7342|NCT02961192|"~     In this study, we will conduct a one-year, four-arm, randomized, controlled trial to compare~     three social incentive-based gamification interventions to control for promoting physical~     activity and weight loss toward improved glycemic control among type 2 diabetics.~   "
7343|NCT02961179|"~     This study will investigate the in-depth the benefits of dairy consumption on glucose~     metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so,~     33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention~     study including a 6-week intensive dairy product consumption period and a 6-week dietary~     counselling period.~   "
7344|NCT02961166|"~     57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal~     membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received~     IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.~      These patients were analyzed regarding length of stay in intensive care unit (LOS ICU),~     length of stay (LOS) in hospital and regarding mortality.~   "
7405|NCT02960334|"~     Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great~     public health significance because of its prevalence, additional morbidity and mortality. It~     provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic~     attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF~     is the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but~     not sufficiently protected against ischemic stroke). It is recommended that over the age of~     65, patients should be screened with pulse palpation or rhythm strip for the presence of AF.~     The MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm~     during one minute. During preoperative consultation, this device will be used to value the~     yield of screening for actionable AF.~   "
7345|NCT02961153|"~     With the development of national economy and medical technology, patients can extend life~     rely on high-end medical facilities. At the same time, the continued treatment cannot bring~     benefits to children, even resulting in poor quality of life of children and bringing high~     medical costs. This makes the limited medical resources are unreasonable distributed.~     Research showed that PICU mortality rate halved over ten years ago, but the data did not~     include death cases who left hospital before death. However, the death number of~     out-hospital were more than death in-hospital. Therefore, the data cannot actually reflect~     China's mortality rate of PICU. The reason analysis was limited to the cause of the disease,~     and does not take the social, economic factors into account. This study include eight PICUs~     of children's Hospital PICU. Critically ill patients are prospectively studied from death~     risk factors, admission status, disease diagnosis, severity of illness, analyzing of the~     risk factors of death from disease diagnosis and death risk factors. In addition, we will~     illuminate the relationship of death and economic factor, especially for who died~     out-hospital after withdraw or stop treatment.~   "
7346|NCT02961140|"~     Anesthetic management and fluid therapy is crucial in esophageal resection and~     reconstruction, which is associated with high incidence of postoperative morbidity and~     mortality. This study aims to investigate the effect of goal directed fluid management on~     the postoperative outcome of esophageal resection and reconstruction.~   "
7347|NCT02961127|"~     The cases were hospitalized patients from two medical centers in Beijing and Harbin~     respectively. Venous blood was collected by standard vein puncture in fasting condition.~   "
7348|NCT02961114|"~     Benign prostate hypertrophy (BPH) and inflammation are common non-cancerous enlargement of~     the prostate, which result in urinary interference and incomplete drainage of the bladder.~     Compression of the urethra is common cause of such resistance of full draining, and may over~     time result in progressive hypertrophy, instability, urgency, nocturia and weakness of the~     bladder musculature.~      Prostatic growth frequently begins in the 30s, and it is estimated that 50% of all males~     have benign enlargement leading to 75% by age 80. BPH and low grade inflammation is one of~     the ten most prominent and costly disorders in males over 50.~      Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms~     can be associated with bladder outlet obstruction (BOO).~      This study utilizes isolation of adipose-derived stem/stromal cellular stromal vascular~     fraction (AD-cSVF) deployed as an IV suspension in sterile Normal Saline (500cc). Due to the~     anti-inflammatory and immunomodulatory effects common to AD-cSVF are tested in relief of the~     inflammatory elements and the concurrent hypertrophy in BPH. Early pilot use has suggested a~     positive effect on these issues, and have relieved much of the incomplete voiding, pain,~     nocturia, delay in starting/stopping urination, and increased urgency and frequency.~      Lipoharvesting of Adipose-Derived tissue stromal vascular fraction (AD-tSVF) is now a common~     closed access to subdermal adipose stromal/stem cell population consisting of both stem and~     stromal cells, each of which are felt to contribute a wide variety of effects and~     potentials. Closed, sterile isolation of the AD-cSVF is possible with advent of closed~     systems to enzymatically release these cells from the actual matrix (scaffolding) within the~     adipose tissue complex (ATC). This group of largely un-designated cell population is~     isolated and concentrated via a standard gradient layer separation by centrifugation. This~     cellular isolate is then suspended in an IV of 500 cc Normal Saline and reintroduced to the~     patient.~      This study is examining the clinical safety and efficacy of this approach, as well as~     tracking the duration of effects and establish a therapeutic interval.~   "
7349|NCT02961101|"~     The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1~     antibody in combination with low-dose decitabine in patients with relapsed or refractory~     malignancies, including Non-Hodgkin'lymphoma, anti-PD-1-resistant Hodgkin'lymphoma,~     gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung~     cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.~   "
7350|NCT02961088|"~     Pasta is an important example of a food which can lower the glycemic index (GI) of the diet,~     a property that has been exploited extensively in studies of low GI dietary patterns.~     Although low-GI dietary patterns have been shown to improve body weight, glycemic control~     and blood lipids, it is unclear whether pasta as part of low-GI dietary patterns will~     improve measures of global adiposity including body weight. The lack of high quality~     knowledge syntheses to support evidence-based dietary guidance of the cardiometabolic~     benefits of pasta represents an urgent call for stronger evidence. To improve evidence-based~     guidance for pasta recommendations, the investigators propose to conduct a systematic review~     and meta-analysis of controlled studies in humans to assess the effect of eating pasta as~     part of a low GI diet compared to other diets on measures of adiposity (body fatness) in~     humans. The systematic review process allows the combining of the results from many studies~     in order to arrive at a pooled estimate, similar to a weighted average, of the true effect.~     The investigators will be able to explore whether eating pasta as part of a low GI diet has~     different effects between men and women, in different age groups and in people with high or~     normal sugar. The findings of this proposed knowledge synthesis will help improve the health~     of Canadians through informing recommendations for the general public, as well as those at~     risk of heart disease and diabetes.~   "
7351|NCT02961075|"~     Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study~   "
7352|NCT02961062|"~     The purpose of this study is to determine if SAF312 eye drops have an adequate safety and~     efficacy profile to justify further clinical development for the treatment of ocular pain~     associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)~     surgery~   "
7353|NCT02961049|"~     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,~     evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The~     presence of gingival displacement with a retraction cord (yes or no) and the category of~     adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected,~     tabulated and submitted to statistical analysis.~   "
7403|NCT02960373|"~     Dried fruits show promising potential for the management of blood glucose. Previous trials~     have reported beneficial effects of raisins on post-prandial glucose and insulin responses~     in healthy individuals when compared with white bread. However, to date there is limited~     data evaluating the potential beneficial effects of other dried fruits (i.e. sultanas, dates~     and apricots). It is also unclear whether dried fruits can be used to lower the postprandial~     glycemic responses to high-GI carbohydrate foods by either displacing available carbohydrate~     (displacement effect) or providing 'catalytic' doses of fructose ('catalytic' fructose~     effect). To address these questions, the investigators propose to assess the GI of 4 common~     types of dried fruit (raisins, sultanas, dates, apricots) (GI effect) and their ability to~     decrease the postprandial glycemic response to white bread by either partially displacing~     available carbohydrate (displacement effect) or by providing a 'catalytic' dose of fructose~     ('catalytic' fructose effect).~   "
44466|NCT02475018|"~     The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in~     reducing the serum cholesterol in human with hypercholesterolemia.~   "
7354|NCT02961036|"~     Questionnaires are frequently used in online research, however recruiting, and completion~     rates of online participants from a variety of cultures and demographic backgrounds can be~     challenging. The challenge is greater in an online cohort because there is no way to observe~     the participant beyond what is contributed online. Poor recruiting and completion can result~     in underpowered research that may not be representative of the sample population. This can~     trigger an increase in costs as the recruitment period may have to be extended until sample~     size is reached. When recruiting and completion rates are inadequate studies may have to be~     terminated and the answer to the research question can remain unknown.~      To mitigate these challenges, incentives may be offered in the form of gift certificate~     draws. There is uncertainty about whether this strategy is effective in online research and~     if the value of the incentive alters the outcome. A randomised trial can be used to test the~     intervention to establish an evidence base.~      This study (SupMatQT) proposes to link with a large 20,000 person international cohort study~     (SupMat) that will test the utility and preferences of journal supplementary materials for~     reviewers, authors,and readers. The research described here will examine the evidence of~     effect for offering a prize draw incentive on rates of recruitment, and completion for~     consented participants. All participants will be entered in the draw. Information about the~     value of the incentive of a prize draw will differ according to what group a participant is~     randomized to. The entry in the prize draw will not be conditional on levels of~     participation or group allocation.~      The other question researchers will address is what effect do survey reminders have on~     outcomes? All non-responders will be sent an initial reminder to complete the survey (Group~     A) and for those who have still not responded a second reminder will be sent 14 days later~     (Group B). Outcomes will be compared at three time points: for initial response, following~     reminder 1(Group A), and following reminder 2 (Group B).~   "
7355|NCT02961023|"~     Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right~     ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted~     therapy, increases EC by improving SV. Additional factors may contribute to exercise~     limitation:~        -  Peripheral and respiratory muscle dysfunction~        -  Autonomic dysfunction~        -  An altered profile of inflammation~        -  Mitochondrial dysfunction.~      The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training~     in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this~     improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting~     treatment goals, will be enrolled in a 30-week randomised exercise training program.~      One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other~     will receive standard care for 15 weeks then 15 weeks training.~      Aims:~        1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug~          therapy a UK PAH population.~        2. Explore mechanisms of exercise limitation and factors that improve with training,~          assessing:~             -  Cardiac function~             -  Skeletal muscle function~             -  Autonomic function~             -  Respiratory muscle strength~             -  Serum and muscle profile of inflammation~      Primary outcomes (15 weeks)~        1. 6 minute walk distance~        2. QOL~        3. RV ejection fraction~   "
7356|NCT02961010|"~     This study evaluates the effectiveness of Keeping Safe, a whole school preventative~     education intervention in improving children's knowledge and understanding to keep safe in~     situations of abuse. The intervention~        -  Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and~          includes content across the following keeping safe concepts; bullying, neglect,~          emotional, physical, domestic and sexual abuse, in online and offline contexts.~        -  Includes activities for the formal and informal school curricula - 63 lessons will be~          taught to children by their classroom teacher; 3 per term, 9 per year across 7 years~          from Primary 1 to primary 7 (age 4-11 years).~        -  Each lesson is accompanied by directed homework activities to involve and engage~          parents and enable them reinforce learning at home. A number of whole school, key stage~          and year group assemblies have also been prepared.~        -  At the beginning of each term school leaders will deliver a prepared assembly to~          introduce the theme for the term. Following this assembly each teacher will deliver 3~          lessons tailored to the age group of their class and parents will assist with home~          works. The lessons use eBooks, character animations, stories, rhymes, and interactive~          whiteboard activities to engage children in their learning.~      The intervention adopts a whole-school approach and seeks to build the capacity and skills~     of teachers and parents as key partners. Teachers will receive a comprehensive package of~     training, ongoing support and resource materials to equip them with the skills they need to~     effectively communicate sensitive keeping safe messages. Parents will also receive a package~     of resources to help them feel confident about communicating sensitive messages to their~     children.~   "
7357|NCT02960997|"~     Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA~     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong~     painful thick soles on their feet, and current standard of care is supportive. This pilot~     study will target the dominant mutant keratin proteins in the skin to ameliorate the~     severity of EB simplex. The purpose is to improve the function of EB simplex feet with an~     application of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway~     to down regulate the translation of defective keratin proteins and work through anti~     proliferative pathways.~   "
7358|NCT02960984|"~     In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been~     shown to exhibit a number of life-altering problems such as fatigue, limb weakness,~     alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These~     problems affect performance of many daily living activities (ADL) such as dressing, bathing,~     self-care, and writing, thus reducing functional independence and self-rated quality of~     life.~      Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising~     a combination of aerobic training and upper limb task-oriented training.~      The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on~     upper limb performance and on fatigue in People with Multiple Sclerosis.~   "
7359|NCT02960971|"~     To understand pain pathophysiology in terms of risk factors and protective mechanisms~     ranging from molecular pathways to societal impacts.~   "
7360|NCT02960958|"~     The aim of this study is to investigate discriminant metabolites in urine from patients with~     rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's~     metabolic fingerprint could predict the development or flare-up of RA.~   "
7361|NCT02960945|"~     This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of~     CTP-543 compared to a single dose of Jakafi® in healthy volunteers.~   "
7404|NCT02960347|"~     The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing~     epileptiform activity in a 30-month-old child suffering from early onset epileptic~     encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks~     including pre- and post-intervention video-electroencephalography (EEG) monitoring.~   "
7367|NCT02960867|"~     Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular,~     in critically ill children. Moreover, AKI is an independent predictor of mortality. An~     incidence of AKI in pediatric intensive care units (PICU) between 10 and 62% has been~     reported in recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk~     present in cardiac surgery patients. Despite significant developments in the management of~     AKI, the overall mortality rate of patients with AKI has not improved significantly.~     Currently, there is no consensus concerning the optimum dialysis modalities to adopt in~     pediatric AKI. No studies have prospectively compared the efficacy of different types of RRT~     for pediatric AKI. While PD remains the most commonly used modality in children worldwide,~     over the last decade CRRT has become the preferred treatment modality for critically ill~     children with AKI in North America.~      The investigators have recently conducted a survey among 34 European Pediatric Nephrology~     Centers in the ESCAPE Network to obtain current information on dialysis management practices~     in children. Approximately 900 children with AKI requiring dialysis are managed at these 34~     centers per year. This number supports the creation of a prospective European AKI registry.~   "
7368|NCT02960854|"~     A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in~     participants with severe sepsis or septic shock.~   "
7369|NCT02960841|"~     The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic~     Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema,~     the prevention of complications during the expulsive and the improvement in the postpartum~     recovery, compared to conventional treatment during the gestation, in women with the second~     partum. The weekly treatment is performed from the 25th gestational week in women with~     vulvar edema.~   "
7370|NCT02960828|"~     This study aims to validate the efficacy and safety of subthreshold laser photocoagulation~     on high-risk macular drusen in early age-related macular degeneration which has a high risk~     of conversion to exudative AMD.~   "
7371|NCT02960815|"~     In this open label, single centre, pilot randomized controlled clinical trial the~     investigators aim to compare the immunogenicity and safety of a new influenza vaccination~     strategy consisting in the topical administration of imiquimod at the injection site before~     vaccination vs. a standard intramuscular vaccine injection in SOT recipients and~     HIV-infected individuals. The investigators planned to enroll 70 outpatients patients (50%~     solid-organ transplant recipients and 50% HIV-infected patients) regularly followed at the~     Transplantation center and the Infectious disease outpatients' clinics of the Lausanne~     University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the~     standard intramuscular vaccine (control group) or a topical application of an imiquimod~     containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID)~     vaccine injection. After vaccination participants will be followed for a period of 180 days.~     Blood samples will be drawn at baseline and at day 21 and 180 for assessment of~     immunogenicity. Safety outcomes will be assessed immediately after vaccine administration,~     and at day 7 (phone call), 21 and 180.~   "
7372|NCT02960802|"~     The cardiovascular morbidity and mortality is significantly higher in chronic kidney disease~     (CKD) patients, especially in dialysis patients, than in normal population. The increased~     risk of cardiovascular diseases is multifactorial.Endothelial dysfunction is one of the~     explanations for the poor outcome of kidney patients. The kidney transplantation seems to~     halt the progression of the cardiovascular morbidity.~      Coronary flow reserve (CFR), the capacity of coronary vessels to dilate in response to~     vasoactive agent, is a marker of the endothelial dysfunction. It is reduced in renal~     impairment as well as in many preatherosclerotic states and coronary heart disease. The~     method of choice to evaluate CRF is positron emission tomography (PET). In kidney transplant~     patients CFR seems to be worse than in healthy controls but better than in dialysis~     patients. However, the evidence is scarce.~      Renal flow reserve (RFR) is smaller than that of heart. RFR probably reflects endothelial~     function in the same way as CFR does. Declining RFR could perhaps be used to anticipate~     worsening kidney function especially in kidney transplant patients and be in favour for~     transplant biopsy.There are no studies of RFR in renal allograft patients.~      The objectives of this study are to examine the effect of kidney transplantation on coronary~     flow reserve (CFR), the change of renal flow reserve (RFR) in kidney transplant patients~     during the first year after transplantation and assess the correlation between the change of~     renal blood flow / RFR and kidney biopsy findings in kidney transplant patients.~      The first hypothesis of this study is that coronary flow reserve of transplant patients is~     better than that of dialysis patients but worse than that of healthy controls. The second~     hypothesis is that renal transplant perfusion reserve is better at one year than at three~     months after transplantation. The third hypothesis is that pathologic kidney biopsy findings~     correlate negatively with renal perfusion reserve.~   "
7373|NCT02960789|"~     A pediatric study in collaboration with Boston Children's Hospital to review the performance~     of two novel hydration status measurement devices against standard clinical assessment~     methods, through repeated measurement of hydration status of dehydrated children admitted to~     the emergency department receiving rehydration therapy, followed by an at-home follow-up~     measurement once symptoms have resolved.~   "
7374|NCT02960776|"~     The overall goal of this project is to look at the effects of long-term, sustained sleep~     restriction (SR) in adults, and assess the effects on mood and cognitive and physical~     performance.~   "
7375|NCT02960763|"~     The purpose of this research study is to assess which antidepressants work the best in older~     adults who have treatment-resistant depression.~   "
7376|NCT02960750|"~     This study assesses the short and mid-term impacts of a workplace web-based intervention~     (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts,~     activity-related energy expenditure, physical risk factors for chronic disease and~     efficiency-related outcomes in Spanish office employees. Half of participants had access to~     the W@WS website program while the other half was asked to maintain habitual behaviour.~   "
7377|NCT02960737|"~     The purpose of this study is to investigate the effect of a specific rehabilitation program~     with oral screen used in stroke patients with persistent oral-and pharyngeal dysphagia.~   "
7378|NCT02960724|"~     uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer~   "
7379|NCT02960711|"~     Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to~     test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent~     age-related chronic non-communicable diseases (ArCD).~      The aim of the present study is to evaluate the effect of a comprehensive life-style~     intervention (including moderate physical activity and Mediterranean/macrobiotic diet with~     moderate calorie and protein restriction), and of treatment with Metformin (a calorie~     restriction mimetic drug) for the prevention of ArCD.~   "
7406|NCT02960321|"~     A prospective study aiming to analyse the relation between different variables and high~     sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary~     angiography with or without subsequent percutaneous coronary intervention.~   "
7380|NCT02960698|"~     Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics.~     Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality~     and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source~     of these troubles. Its anatomical substrates is based on connections between frontal and~     striatal areas.~      Initially, a battery of behavioral tests measuring different types of impulsivity (motor,~     cognitive and decision) will be administered on three groups of subjects: TS: 80 patients~     (40 patients treated and 40 untreated) and 40 healthy volunteers.~      Then, investigators will study the fronto-striatal connections in the TS group of 80~     patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using~     neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study~     of resting state MRI (RS-fMRI) combined with a reconstruction of white matter fibers by~     diffusion tensor imaging (DTI). Behavioral performance will be correlated with the~     correlation imaging data to highlight the functional anatomical substrates of impulsivity in~     patients with TS.~      Finally, investigators will look specifically using functional MRI activation, the~     anatomical and functional substrates of the three types of impulsivity (motor, cognitive and~     decision-making).~      Through this study, investigators hope to elucidate the anatomical and functional bases of~     cognitive impulsivity in patients with TS and thus lay the basis for more targeted~     treatments.~   "
7381|NCT02960685|"~     Background: Given that an experienced physician is not always available 24 hours a day,~     immediately and always available echocardiography is usually impossible in the emergency~     department (ED) and intensive care unit (ICU). To compensate this limitation, the~     investigators have investigated that offsite expert guided, inexperienced~     practitioner-performed ultrasonography could be effectively performed. In this study, the~     investigators aimed to investigate whether the offsite expert can effectively evaluate the~     visually estimated ejection fraction (EF) while watching and guiding the echocardiographic~     procedure of onsite novice examiner using the social network video calling chat.~      Methods: sixty patients presenting to the ICU and requiring echocardiography will be~     included. Sixty novice practitioners without any previous experience of echocardiography~     will participate. Prior to their procedure, the onsite expert complete the echocardiography~     in advance and determine the EF using the modified Simpson's method (MSM, Reference value).~     Then, the novice physicians perform the echocardiography again with the offsite expert's~     guidance via video call. They obtain parasternal long and short axis view and EF is visually~     estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the~     ultrasound video on the smartphone display. The subjects requiring immediate management due~     to severe symptoms were excluded in this study. Interobserver variability between the~     calculated by onsite expert and visually estimated by offsite expert was assessed. The~     agreement of the visual estimated EF obtained by onsite expert and offsite expert via~     smartphone was evaluated by linear regression and Bland-Altman plots.~   "
7382|NCT02960672|"~     Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly~     variable clinical process.thence it is significant for the patient to search a convenient~     and accurate prediction method. The objective of this study was to determine whether~     peripheral blood biomarkers can predict disease .~   "
7383|NCT02960633|"~     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or~     without collar design. Randomized study design focusing on radiolucent lines on standard~     x-ray.~   "
7384|NCT02960620|"~     This is not a research study. The purpose is to provide supervised access to TheraSphere®~     therapy at this institution.~   "
7385|NCT02960607|"~     The purpose of this study is to investigate whether high-dose icotinib treatment beyond~     disease progression is beneficial for NSCLC patients who have EGFR mutation and who have~     responded to EGFR TKI.~   "
7386|NCT02960594|"~     This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity~     of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects~     with high-risk solid tumor cancer with no evidence of disease after surgery and standard~     therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed~     according to standard of care. Restaging and imaging studies will be performed to assess~     disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases~     of relapse.~   "
7387|NCT02960581|"~     This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and~     anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.~   "
7388|NCT02960568|"~     The investigator proposes to 2D6 (Cytochrome P-450 Isoenzyme 2D6) genotype and phenotype a~     group of active duty service members and assess the effects on primaquine metabolism.~   "
7389|NCT02960555|"~     The goal of this clinical research study is to learn if isatuximab can help to control~     smoldering multiple myeloma (SMM). The safety of this drug will also be studied.~   "
7390|NCT02960542|"~     This pilot study is designed to adapt a community-based diabetes prevention program to reach~     adults at risk for cancer.~   "
7391|NCT02960529|"~     Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic~     high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since~     laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly~     performed hernia repair in children. The conventional approach this is done with2small~     trocars to 1trocar . however the wound complications of infection and pain and the recurrent~     rate have not been resolved. The aim of the study was to described a new way of~     extra-peritoneal high ligation of hernia sac. This method combines the single-port~     laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia~     repair in children. The investigators hoped that this study will prove that the~     extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as~     the conventional technique in the cure of inguinal hernia and may results in lower~     recurrence and reduce incidence of wound complications.~   "
7407|NCT02960308|"~     This pilot clinical trial studies how well whole-neck computed tomography perfusion scans~     work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as~     whole-neck computed tomography perfusions scans, may provide more information about the~     blood supply to head and neck tumors which may help doctors plan better treatment.~   "
44467|NCT02475005|"~     The purpose of this study is to test the efficacy of a new app to help adolescents with~     chronic or reoccurring headaches self manage pain.~   "
7392|NCT02960516|"~     It is estimated that up to 5% of all admissions to level one trauma centers have a~     peripheral nerve injury. These peripheral nerve injuries may have devastating impacts on~     quality of life and require months or years to regain function. Neurotmesis, or peripheral~     nerve transection, is a common injury, with singly cut nerve lacerations accounting for over~     60% of the peripheral nerve surgical interventions in civilian studies. For recovery to~     occur in these patients, axons must grow from the site of repair to the target tissues, a~     length of up to a meter in humans. By that time, revisional surgery may not be a viable~     option due to the onset of irreversible muscle atrophy - a transected nerve is estimated to~     induce a loss of achievable function of approximately 1% for every 6 days of delay. The~     scenario is even worse for more proximal nerve injuries, such as those that occur in the~     brachial plexus.~      The investigators aim is to longitudinally assess diffusion tensor tractography (DTI) in~     order to optimize, validate, and translate the ability of DTI to monitor and, more~     importantly, predict nerve regrowth following trauma and surgical repair. The overall~     objective of this study is to evaluate the ability of (DTI) to monitor and, more~     importantly, predict nerve regrowth following crush or cut with surgical repair. The~     investigators hypothesize that the additional information available via DTI will improve our~     ability to monitor and predict nerve regrowth following surgical repair or severe crush~     injury, guiding clinical management either toward or away from surgical intervention.~   "
7393|NCT02960503|"~     Sickle cell anemia (SCA) is a life-threatening, monogenic disorder associated with early~     death when compared to individuals without SCA. Pulmonary complications, namely acute chest~     syndrome, obstructive lung disease and pulmonary hypertension, are the most common causes of~     death in patients with SCA. Recent studies suggest that lung specific inflammation is a~     hallmark of SCA and underlies pulmonary pathology. To date, no therapy has been shown to~     improve the pulmonary complications of SCA. Macrolides have pleomorphic effects in the lung~     with improvement in pulmonary function, symptoms and inflammatory markers demonstrated in~     several inflammatory pulmonary conditions such as cystic fibrosis, asthma, COPD and~     post-transplant bronchiolitis obliterans. Investigators hypothesize that low dose macrolide~     therapy is well tolerated and can improve pulmonary function and symptoms in patients with~     SCA. The objective of this project is to assess the feasibility of macrolides to attenuate~     or reverse the decrease in %predicted FEV1 in adults with SCA in a single-site, randomized,~     placebo-controlled feasibility trial.~   "
7394|NCT02960490|"~     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group~     comparison study in rheumatoid arthritis participants inadequately responding to biologics.~   "
7395|NCT02960477|"~     BACKGROUND Shoulder pain is the third most common musculoskeletal disorder observed in~     primary care consultations after low back and neck pain. In the absence of successful~     outcome following a conservative intervention, shoulder surgery is the most common procedure~     conduct for a multitude of surgical indications, including rotator cuff tears, instability~     and stiffness. However, 22% of patients develop chronic shoulder pain (CSP) following~     shoulder surgery . The consequences of chronic or persistent postsurgical pain result in~     high socio-economic burden, not only in terms of suffering and reduced quality of life for~     the individual, but also, with considered the subsequent costs to healthcare and social~     services.~      Pain neuroscience education (PNE) has been shown as an effective therapeutic strategy for~     increasing knowledge and understanding about neurobiology, neurophysiology and processing~     pain, changing pain beliefs, improving patient's skills and encouraging to do physical and~     social activities in different chronic pain conditions.~      The primary aim of this study will be to evaluate whether perioperative PNE is more~     effective than classical biomedical education in reducing pain and disability in patients~     undergoing shoulder surgery. The secondary aim will be to analyse whether perioperative PNE~     is more effective than classical biomedical education in reducing postoperative healthcare~     costs and improving surgical experience in patients undergoing shoulder surgery .~   "
7396|NCT02960464|"~     Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a~     treatment of depression in patients with Parkinson's Disease, through a randomized~     placebo-controlled clinical trial.~   "
7397|NCT02960451|"~     The purpose of this study is to determine whether specialty care is superior to usual care~     in the treatment of patients at clinical high risk for psychosis.~   "
7398|NCT02960438|"~     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group~     comparison study in rheumatoid arthritis participants inadequately responding to~     methotrexate.~   "
7399|NCT02960425|"~     Creatine is a nutritional supplement that is often ingested to improve exercise performance.~     The advent of a new product that is applied to the skin overlying muscle offers potential~     benefit, if the creatine can be targeted to specific muscles. The investigators are testing~     a novel creatine cream to determine the effects on human muscular performance. The~     investigators are assessing the acute application of two different doses of the creatine~     cream on muscular power (determined by knee extension).~   "
7400|NCT02960412|"~     This study evaluates if administration of IV furosemide leads to expedited confirmation of~     ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after~     urogynecologic surgery.~   "
7401|NCT02960399|"~     Recommendations concerning the administration of Zostavax® in patients with antibody~     deficiency are unclear. The investigators plan to assess the immunogenicity and safety of~     Zostavax® in patients with antibody deficiency as compared with healthy volunteers.~   "
7402|NCT02960386|"~     The iTrackFitness study aims to test the engagement engine that was developed from~     activity tracker and survey data gathered during phase I of the study. For the current phase~     the engagement engine will support successful and sustained engagement with health~     trackers thereby increasing physical activity.~   "
7408|NCT02960295|"~     This is a feasibility study of care for women with gestational diabetes (GDM) using~     electronic equipment to participate in virtual office visits.~      Participants will be trained in the use of glucose meters, scales, and sphygmomanometers~     which are Bluetooth connected to an app on their cellphones. Fetal well-being will be~     assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and~     telephone visits.~   "
8500|NCT02946021|"~     Assessment of lymphatic structure and function pre- and post- treatment and during recovery~     in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic~     imaging: Response to ICD therapy in HNC Patients.~   "
7411|NCT02960256|"~     Sepsis related to the development of cardiac complications. However, the investigators~     understanding regarding this condition remains incomplete. Possible explanations raised~     include coronary perfusion decrease, activation of the coagulation system and release of~     inflammatory mediators, including endotoxins, cytokines and others.~      In this study the investigators wanted to examine the impact of any infectious disease, (not~     necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious~     disease.~   "
7412|NCT02960243|"~     Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is~     a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily~     shake. The DBS surgical procedure involves implanting an electrode deep within the brain~     which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the~     vocal manifestation of ET and a number of individuals have both ET and EVT, and when these~     patients are implanted for their ET, their EVT symptoms are often also mitigated. This study~     aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition~     to this, we hope to determine which hemisphere of the brain is responsible for larynx~     control: left or right.~   "
7413|NCT02960230|"~     This is a two cohort Phase I study within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      This study will assess the safety of repeated administration of the H3.3K27M specific~     vaccine in HLA-A2+ children and young adults with H3.3K27M DIPGs and other gliomas.~   "
7414|NCT02960217|"~     UX007G-CL301 is a Phase 3, randomized, double-blind, placebo-controlled, crossover study to~     assess the efficacy and safety of UX007 in the treatment of movement disorders associated~     with Glucose Transporter Type 1 Deficiency Syndrome. The study will enroll approximately 40~     subjects who experience disabling paroxysmal movement disorders.~   "
7415|NCT02960204|"~     This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects~     with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined~     by the central reader assigned to this study). Upon successful screening, subjects will be~     randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo~     BID.~   "
7416|NCT02960191|"~     The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions~     associated with vulnerability to suicidal behavior.~   "
7417|NCT02960178|"~     Falling is common among individuals with incomplete spinal cord injury (iSCI), with most~     falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital~     readmission, and reduced participation in work and recreation. In able-bodied people, falls~     can be prevented by taking one or more rapid, reactive steps. People with iSCI, however,~     have difficulty taking the reactive steps needed to prevent a fall. Research in the elderly~     and people with stroke has shown that repetitive training of reactive steps in a safe~     environment improves this balance reaction and prevents falls. The investigators will~     examine the feasibility and effectiveness of reactive step training in people with iSCI. The~     main objective is to determine if reactive balance training leads to greater improvements in~     balance reactions, scores on clinical scales, and fall rates compared with conventional~     walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By~     improving balance and reducing falls, people with iSCI will experience fewer complications~     (e.g., injuries), and greater recovery of function and community participation.~   "
7418|NCT02960165|"~     Objective: Evaluate whether a task practiced in virtual environment could provide better~     performance than the same task in real environment and if performing a task in virtual~     environment could enable transfer to the same task in real environment and vice versa.~     Method: the investigators evaluated 65 older adults of both genders, aged 60-82 years. The~     investigators applied a timing coincident task to measure the perceptual-motor ability to~     perform a motor response. The participants were divided into two groups: a) started in a~     real interface and b) started in a virtual interface.~   "
7419|NCT02960152|"~     This study evaluated the periodontal status of patients suffering from eating disorders~     (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients~     have a higher risk for periodontal diseases than non-eating disorder subjects.~   "
7420|NCT02960139|"~     The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled,~     multicenter superiority clinical study comparing standard anastomosis closure technique~     (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled~     colorectal and ileorectal anastomosis procedures.~   "
7421|NCT02960126|"~     This study was designed in order to evaluate and compare the efficacy and safety between~     aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).~   "
7422|NCT02960113|"~     The purpose of this study is to compare the effectiveness of reducing intra-cesarean section~     nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch~     with acupressure point P6 stimulation versus subjects that receive just scopolamine patch~     versus subjects that receive just acupressure point P6 stimulation.~   "
7423|NCT02960100|"~     This randomized pilot trial studies how well a mobile health (mHealth) intervention works in~     increasing human papillomavirus (HPV) vaccination among college students at the Ohio State~     University. mHealth educational intervention may communicate information about HPV~     vaccination and increase HPV vaccine uptake in college students.~   "
7424|NCT02960087|"~     The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy~     chosen for this study as well as a commonly used alternate form of brachytherapy called low~     dose rate (or seed) brachytherapy. Investigators would like to understand how these~     treatments control the prostate cancer and look at their short and long term treatment~     related side effects.~   "
7425|NCT02960074|"~     This is a Phase I trial to evaluate the safety and efficacy of fecal microbiota~     transplantation (FMT) in the treatment of peanut allergy. In this research the investigators~     would like to learn more about ways to treat peanut allergies. There is currently no known~     cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in~     patients with peanut allergy aged 18-40 years.~   "
7426|NCT02960061|"~     The investigators intend to conduct a randomized controlled study to find if combining HIPEC~     (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2~     resection could improve survival for patients with advanced gastric cancer, while comparing~     with the traditional approach of D2 resection after neoadjuvant chemotherapy.~   "
7428|NCT02960035|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection~     (Yisaipu®) in the treatment of peripheral enthesitis in active axial spondyloarthritis(SpA)~     patients. Mardird sonographic enthesis index (MASEI) was one of the most wide used scoring~     systems for peripheral enthesitis and the only one based on OMERACT definition of~     enthesopathy by EULAR. The primary purpose is to assess the MASEI to discover the value of~     US in diagnosis and prognosis. The second prupose is to assess different maintaining~     treatment programme in SpA patients with improvement of MASEI. The trial will include 96~     patients with stable NSAIDs therapy, and at the first stage they will receive 24-week~     full-dose of Yisaipu®. Then at the second stage the patients who achieve low disease~     activity (LDA, ASDAS<2.1) at 24th week will be randomizedly divided into three group:~     full-dose of Yisaipu® group, half-dose of Yisaipu® group and placebo group. And the blind~     stage will last for 24 weeks. Patients who complete the 48-week therapy or achieve~     disease-flare criteria during the blind stage would finish the study.~   "
7429|NCT02960022|"~     The purpose of this study is to collect long term safety data in subjects who are continuing~     to derive clinical benefit from treatment with Enzalutamide from the subjects participation~     in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)~     which has completed, at a minimum, the primary analysis or the study specified evaluation~     period.~   "
7430|NCT02960009|"~     High definition tDCS will be conducted to both stroke and healthy subjects on primary motor~     cortex area to explore the motor excitability changes before and after stimulation.~   "
7431|NCT02959996|"~     This is a randomized controlled trial to test whether the use of liposomal bupivacaine at~     the time of cesarean delivery may decrease post-operative pain scores.~   "
7432|NCT02959983|"~     This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a~     day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with~     Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to~     provide control of their IBS-D symptoms.~   "
7433|NCT02959970|"~     This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of~     ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with~     acne vulgaris.~   "
7434|NCT02959957|"~     This study will evaluate the ecological impact on the intestinal microbiota and compare the~     safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile~     UTI. Half of participants will receive temocillin and the other half will receive~     cefotaxime.~   "
7435|NCT02959944|"~     To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects~     with newly diagnosed moderate to severe cGVHD.~   "
7436|NCT02959931|"~     The investigators aim to evaluate the acute effects of potassium supplementation achieved by~     ingestion of potassium rich food, on vascular health.~   "
7437|NCT02959918|"~     This is an open label multicenter study to evaluate the safety and tolerability of multiple~     doses(3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase( SEL-037) and~     SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase~     (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and~     hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV~     infusions) of pegsiticase (SEL-037) alone.~      Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days~     .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum~     uric acid levels.~   "
7438|NCT02959905|"~     The primary purpose of this study is to evaluate the safety of TSA-CTL in the treatment of~     the advanced melanoma.~      The secondary purpose of this study is to evaluate preliminarily the effect of TSA-CTL in~     the treatment of the advanced melanoma.~   "
7439|NCT02959892|"~     The purpose of this study is to determine brain penetration of single oral doses of TAK-041~     and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).~   "
7440|NCT02959879|"~     In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed~     by adjuvant chemotherapy is currently the standard of care. However, the long-term results~     are still poor, with median disease-free and overall survival of 14 months and 23 months.~     The corresponding 5-year overall survival rate is 20%.~      Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients~     with rapidly progressive metastatic disease at time of preoperative restaging (surgery is~     then avoided in these patients), and may increase the rate of free margin resection (R0) and~     reduce the risk of local recurrence.~      Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic~     settings, the objective response was low (at around 10%), whereas combination chemotherapy~     exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative~     FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates~     and progression-free survival) and well tolerated. Interestingly, the response rate is~     increased by using more than two chemotherapeutic agents in advanced pancreatic cancer,~     justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.~      PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to~     assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX &~     FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy)~     for resectable PDAC.~      Patients with immediately resectable PDAC (definition based on the NCCN's (American National~     Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either~     pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either~     FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive~     postoperative chemotherapy for 4 months (8 cycles).~   "
7441|NCT02959866|"~     We will evaluate the acceptability, feasibility and impact of an online tool that helps~     patients identify financial benefits that they are entitled to at six clinic sites over a~     three month period. We will answer the following questions: Is an online tool that addresses~     income security feasible and acceptable to clinicians? Can such a tool be integrated into~     regular clinic workflow? What is the patient perspective on the tool and what is the~     short-term impact?~   "
7454|NCT02959697|"~     Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure~     usually performed using local anesthetic. However, a subset of patients appears to~     experience intraoperative pain/discomfort during ptosis repair using an anterior approach~     with subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently~     used for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid~     resections. The purpose of this study is to determine whether an additional subconjunctival~     injection of local anesthetic, through the posterior aspect of the eyelid, reduces~     intraoperative pain during anterior ptosis repair.~   "
9042|NCT02938871|"~     The purpose of this study is to evaluate the use of synbiotic in patients after liver~     transplantation and assess the effect of these agents on postoperative infections,~     antibiotic use, length of hospital stay, mortality and nutritional status.~   "
7442|NCT02959853|"~     After the age of 40, there is a gradual decline in the production of testosterone. Among~     obese men, the decline in testosterone levels is exacerbated by the suppression of the~     hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase~     enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in~     turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition~     of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and~     follicle stimulating hormone (FSH), and as a consequence, of testosterone by the testis~     resulting in hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side~     effect of AI in certain populations, such as women with breast cancer, HH obese men present~     high levels of circulating estrogens that could potentially prevent them from bone loss,~     estradiol being the main regulator of the male skeleton. This study is designed to determine~     if aromatase inhibitors in combination with weight loss, compared to weight loss alone, will~     have a positive effect on muscle strength, symptoms of hypogonadism, and body composition~     without negatively impacting bone mineral density and bone quality. Results from this study~     will help determine if certain groups of obese patients would benefit from therapy with~     aromatase inhibitors.~   "
7443|NCT02959840|"~     The purpose of this study is to compare the effectiveness of acupressure point P6~     stimulation versus intravenous ondansetron plus metoclopramide versus no antiemetic~     prophylaxis during elective cesarean section under regional anesthesia.~   "
7444|NCT02959827|"~     This study will estimate the incidence of hypothyroidism in a pediatric population of~     children under age 4, based on data from the US-based Kaiser Permanente Northern California~     database, which were exposed to iodinated contrast agent through having a diagnostic~     procedure.~   "
7445|NCT02959814|"~     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance~     of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on~     two angiographic projections. The purpose of the FAVOR II study is to evaluate the~     diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA)~     with FFR as gold standard.~   "
7446|NCT02959801|"~     The purpose of this study was to compare the efficacy of Percutaneous mechanical~     thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy~     alone, for the treatment of acute proximal lower extremity deep vein thrombosis.~   "
7447|NCT02959788|"~     Identification of patients who are at highest risk for heart attack is an important task for~     emergency medicine physicians. Currently, physicians use a variety of different scoring~     systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a~     measure derived from noninvasive cardiac monitoring. This data is collected from a simple,~     non-invasive chest strap during a 10-minute recording session. The purpose of this proposal~     is to collect heart rate variability data on patients admitted to the emergency department~     with chest pain. The intent is to measure the association between heart rate variability and~     the various risk stratification scoring systems for chest pain.~   "
7448|NCT02959775|"~     Uptake, adherence, and completion of vaccination among drug users were low, and their immune~     function and immune response to hepatitis B vaccination were also suboptimal, indicating~     that the current practice of hepatitis B vaccination can't protect drug users from HBV~     infection.~      This is a randomized, open-label, blank-controlled trial, conducted among drug users with~     drug rehabilitation. This study will compare the immunogenicity and safety of three~     intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among~     drug users~   "
7449|NCT02959762|"~     Animal studies have found that vitamin K-dependent proteins matrix Gla protein and~     osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this~     concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K~     supplementation presents an opportunity to test the hypothesized link between the vitamin~     K-dependent proteins and markers of lipid and glucose metabolism. The investigators will~     conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein~     and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk.~     Sixty obese children will be randomly allocated to either the control group receiving~     placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K~     (menaquinone-7).~   "
7450|NCT02959749|"~     Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic~     change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in~     non-small cell lung cancer. After a 10 to 14 months median progression-free survival with~     the treatment of first generation EGFR TKI, half of patients will get disease~     progression.For patients progression after treated with first line EGFR TKI and second line~     double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is~     quite critical important for benefit patients' survival. We conducted this study was aimed~     to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the~     third line therapy in patients with local advanced or metastatic non-squamous cell lung~     cancer.~   "
7451|NCT02959736|"~     The purpose of this project is to further develop a standardized music-based measure used in~     music therapy with adults who have emerged from coma following profound brain injury, but~     are not able to demonstrate responsiveness to their environment due to complex clinical~     needs. Building on previous work, the project aims to strengthen the psychometric properties~     (e.g. concurrent validity, responsiveness) of the measure for its use with adults with~     profound brain damage.~   "
7452|NCT02959723|"~     The current aims to combine analysis of different inflammatory biomarkers and BMPR2~     mutations, which are currently analyzed in each patient diagnosed with idiopathic or~     familial PAH, to establish an earlier diagnosis and consequently better orientate the~     therapeutic strategy in PAH.~   "
7453|NCT02959710|"~     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of~     acetoacetate) levels after single dose administration of AC-1204 mixed in water, AC-1202~     mixed in water and AC-1202 mixed in Ensure®.~   "
7455|NCT02959684|"~     To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV~     and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen~     for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical~     check-up. This study aims for a global improvement of screening and care for migrants.~   "
7456|NCT02959671|"~     A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive~     EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of~     brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014 or~     0.016 Nickel-Titanium archwires.~      A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all~     mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular~     incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead.~     Other mandibular brackets will remain in place. Tooth movement will be performed using~     0.019x0.025 Stainless Steel archwires.~      In both cohorts bracket door stability, the ability of the door to hold the archwire in the~     bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the~     bracket, and patient comfort in comparison with other brackets will be assessed.~      The evaluation for each patient will last for at least until one archwire change (cohort 1)~     or one appointment interval (6-8 weeks, cohort 2).~      After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place~     until the orthodontic treatment is completed.~   "
7457|NCT02959658|"~     This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients~     with primary progressive multiple sclerosis (PPMS).~      Half of the patients will receive dimethyl fumarate and the other half will receive placebo.~   "
7458|NCT02959580|"~     This study evaluates the clinical response rate of topical steroids in the treatment of~     idiopathic granulomatous mastitis in female adults. Half of the participants will receive~     topical steroid and the other half will receive local wide surgical excision.~   "
7459|NCT02959567|"~     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing~     on diagnostic or operative hysteroscopies.~   "
7460|NCT02959554|"~     This study aims to assess the survival benefit from an early switch approach from sunitinib~     or pazopanib (10-12 weeks of 1st-line therapy) to nivolumab (anti-angiogenic to~     immunotherapy switch).~   "
7461|NCT02959541|"~     This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of~     Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from~     patients with colon cancer~   "
7462|NCT02959528|"~     Previous studies indicated that children with attention-deficit/hyperactivity disorder~     (ADHD) often suffer from deficits in executive function, such as attentional control,~     inhibition, and working memory. One of these executive functions, working memory, plays a~     critical role in academic performance and classroom behavior. Working memory is essential~     for performing complex cognitive tasks such as comprehension, learning, and reasoning.~     Several studies have shown that training of working memory has positive effects for ADHD and~     other cognitive disorder in children. However, transfer effects across studies appear to be~     variable and inconsistent. Event-related potentials can be a useful tool to gain insights~     into such mechanism. Therefore, the aim of the present study is to investigate both near and~     far transfer effects of N-back training in children with ADHD. In addition, the recording~     and analysis of event-related potentials will be adopted while children with ADHD perform~     the complex visuo-spatial and phonological working memory tasks.~   "
7463|NCT02959515|"~     The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and~     OLV+capnothorax and CPAP.~   "
7464|NCT02959502|"~     The overall goals of this project are to assess the feasibility and impact of designing and~     implementing an at-home intervention aimed at preventing long-term cognitive decline and~     improving cognition in individuals currently at-risk for developing AD.~   "
7465|NCT02959489|"~     This study is intended to examine the impact of learning amyloid brain imaging results among~     asymptomatic older adults, and how to safely communicate these results and educate on the~     risk of developing Alzheimer's disease.~   "
7466|NCT02959476|"~     This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of~     post-surgical pain in patients undergoing Cesarean delivery. Half of the patients will~     receive Ropivicaine and half will receive placebo.~   "
7467|NCT02959463|"~     The goal of this clinical research study is to assess the safety of pembrolizumab (also~     called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in~     patients with MPM.~   "
7468|NCT02959450|"~     The purpose of this trial is to design, implement and evaluate the effect of a nutritional~     intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of~     energy and protein.~   "
7469|NCT02959437|"~     This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors.~     The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation~     assessment to evaluate the safety and tolerability of the DNA methyltransferase inhibitor~     azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor~     pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat. Once the~     recommended doses have been determined, subjects with previously treated NSCLC and~     microsatellite-stable colorectal cancer (CRC) will be enrolled into expansion cohorts in~     Part 2.~   "
7470|NCT02959424|"~     Chronic esophageal disorders affect approximately one third part of global population, with~     a deleterious impact in the quality of life of patients. Measured of health related quality~     of life in chronic esophageal conditions such as gastroesophageal reflux disease and~     achalasia are widely used to measure this important patient-reported outcome. The~     Northwestern Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness,~     allowing for broad use across esophageal diseases while maintain sensitivity to nuances of a~     specific condition. The NEQOL is a reliable and valid hybrid measure of disease specific~     health related quality of life across several chronic esophageal conditions. The Ecuadorian~     Institute of Digestive Diseases aims to translate and validate this survey into Spanish for~     its use in a Hispanic population. This cross-sectional study aims to translate, apply and~     validate the NEQOL in the patients attending in the esophageal division of the institute.~   "
7471|NCT02959411|"~     This study will clarify the clinical usefulness of Tolvaptan therapy in patients with~     complicated acute decompensated heart failure and hyponatremia (low blood sodium).~   "
7502|NCT02959008|"~     Cerebral autoregulation can be explained by a tight coupling between oxygen supply and~     demand of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in~     the context of changes in cerebral perfusion pressure. In this study, investigators use~     Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.~   "
7472|NCT02959398|"~     Tomosynthesis is an innovative technique developed in digital mammography for obtaining a~     sectional image of the breast. Mammography has the main disadvantage of being an imaging~     projection that creates overlays, which eliminates tomosynthesis.~      The objective of this study is to evaluate if the BI-RADS classification obtained by~     tomosynthesis with synthetic mammography is superior to that obtained by conventional~     mammography in terms of specificity while not inferior in terms of sensitivity.~   "
7473|NCT02959385|"~     Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care~     for patients with resectable locally advanced oesophageal cancer. Many studies suggest that~     definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus~     surgery for esophageal cancers who respond to chemoradiation. Herein, a single center~     prospective randomized phase II clinical trial will be carried out to compare efficacy and~     safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical~     resection in patients who achieved clinical complete response(CCR) after neoadjuvant~     radiochemotherapy for stage II-III esophageal Cancer.~   "
7474|NCT02959372|"~     Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an~     important health problem because of its high prevalence, morbidity, mortality and associated~     costs. Research shows at least 40% of HF in-patients are going to be readmitted in the~     following year. Thus, new strategies to reduce HF decompensations are needed.~      In recent studies, pulmonary congestion which is expressed in the form of B-lines detected~     by lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization~     and mortality in HF. Moreover, the use of LUS is becoming more common due to its~     availability (with pocket devices with sizes approaching those of smart phones); its~     simplicity (rapid learning curve and rapid examination, less than 5 minutes) and its safety~     (radiation free).~      We hypothesize that a management guided by LUS in HF patients may improve outcomes.~      Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of~     patients after a hospitalization for HF, decreases the combined end-point of mortality or~     re-hospitalization after a 6 months follow-up.~      Study design: The design of our study is a randomized, simple blinded, clinical trial.~      Eligible patients are patients older than 18 years of age who have been hospitalized for HF.~     The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung~     ultrasound. Eligible patients are going to be randomized into either the LUS group or the~     control group.~      The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months~     after the initial hospitalization. LUS is going to be performed on all patients despite~     their respective group. Only in relation to the LUS group, the treating physician will~     have the result of the examination and the subsequent treatment adjustment could be made in~     response to those findings.~      This study complies with the Declaration of Helsinki and the study protocol is being~     evaluated by the Ethic Committee of our institution.~   "
7475|NCT02959359|"~     For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay~     curative treatments. However, recurrence is still a major issue after the surgery or RFA.~     Only selected patients are eligible and tolerable to IFN-based treatment after surgical~     resection and the sustained virological response varied.~      Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high~     SVR and being recommended by AASLD and EASL. Mixed HCV genotype infection accounts for 10%~     of CHC patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as~     Sovaldi plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2~     HCV infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify~     the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for~     genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an~     unexpected high recurrence rate in HCC patients under DAA treatment was reported once.~     However, one recent study showed a low risk of HCC recurrence after DAA treatment. In this~     study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative~     treatment for their HCC, either by surgery or RFA. For the cases fulfilling the~     inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided~     for all cases (single armed design). The primary objective of the study is annual~     recurrence-free survival after curative resection of HCV-HCC for up to 5 years. A~     hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei~     Veterans General Hospital and Investigated Sites will be recruited as historical controls.~   "
7476|NCT02959346|"~     Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in~     recent years. Patients who received thoracoscopic surgery recovered much quickly and~     returned to their daily life sooner because of small operation wound and less invasion.~     However, operative pain was still an important factor, which might contribute to several~     post-operative complications.~      In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory~     drugs and opioid agents, or patient-controlled analgesia for post operative pain control.~     However, some side effects were observed occasionally.~      The role of acupuncture in post-operative pain control was frequently discussed in recent~     research. The main mechanisms of acupuncture in pain control were (1) to stimulate the~     release of endogenous opioid and (2) to block TRPV1 receptor.~      The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the~     first clinical trial investigated the role of acupuncture in post-operative pain control for~     traditional thoracotomy patients. However, there was no further research about the role of~     acupuncture applied to minimal invasive thoracoscopic surgery.~      Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture~     in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order~     to deliver a safe and effective way in pain control, and to save medical cost and promote~     quality of patient care.~   "
7477|NCT02959333|"~     Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another~     part of the body, may develop when there are penetrating wounds of the thorax and after lung~     surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of~     mortality and teratogenicity.~      The investigators will conduct endoscopic injection of human amniotic epithelial cells to~     fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate~     the application of human amniotic epithelial cells in the treatment of bronchial fistula.~   "
7503|NCT02958995|"~     The purpose of this study was to evaluate whether treatment with pioglitazone is associated~     with risk of incident cancer at the 10 most common sites in a cohort of participants with~     recognized diabetes along with the assessment of association between diabetes severity and~     cancer risk.~   "
7504|NCT02958982|"~     RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this~     study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple~     ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase~     asthmatic response to allergen challenge in patients with mild asthma.~   "
7478|NCT02959320|"~     Displaced femoral neck fractures are one group of hip fracture patients that are commonly~     treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective~     hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in~     helping patients to quickly obtain high postoperative function. This approach has also been~     shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies.~     However, the only studies that directly compare two approaches for hip arthroplasty for~     femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach~     (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA.~     The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our~     institution, so we are setting out to determine the differences between them.~   "
7479|NCT02959307|"~     Transcranial Light Therapy involves non-invasive and invisible beams of light that increase~     energy metabolism in the brain. Transcranial light therapy has been found to promote brain~     metabolism which may help people with depression. The research team proposes a novel~     approach to treating depression by using transcranial light therapy.~   "
7480|NCT02959294|"~     Concussion is the most common type of brain injury throughout life. Study is seeking~     improvement of long-term residua following adolescent and adult post-traumatic injuries~     often associated with contact sports and accidental causes. Typically defined as reversible~     head injury with temporary loss of brain function. Symptoms range from physical, cognitive,~     pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome.~     Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function~     following concussion, particularly in contact, repetitive sports injuries. Range of damage~     is measured in Grade I-III according to graduated severity. Unfortunately, less information~     is available about repetitive concussions and the long-term health issues.~   "
7481|NCT02959281|"~     The purpose of this study is to investigate whether hemodynamic data obtained by a~     noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome~     type I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to~     the caring physician will improve management of CRS1 patients.~   "
7482|NCT02959268|"~     This is a Prospective open-label, comparative pivotal study with comparison of~     self-assessments with blinded investigator assessments. Pregnant women attending the labor~     and delivery unit of the hospital or emergency clinic and reporting unidentified wetness~     (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be~     enrolled in this study. After informed consent is obtained, each subject will be given a~     single AL-SENSE to use up to 12 hours or until the perception of wetness.~      Product Usage~      After usage, the subject will read and record any occurrence of color change of the AL-SENSE~     10 minutes after the liner removal and to mark if it changes color to blue or to green or~     not on the designated form. The subjects will fill out the questionnaire regarding the~     product usage experience and the liner color reading with no help from the investigator, to~     validate IFU reading comprehension. A blinded clinician will perform a standard clinical~     diagnosis (clinical assessment). The standard clinical diagnostic methods will include the~     following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive~     Pooling test and/or positive results in both the pH test and the Ferning test will be~     defined as a positive clinical test result.~   "
7483|NCT02959255|"~     Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal~     disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated~     lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the~     International Agency for Research on Cancer. Since then, many consensus conferences and~     clinical guidelines worldwide have been established for the treatment of H. pylori~     infection.~      Despite H. pylori infecting an estimated 50% of the global population,there is no~     universally effective regimen in everyday clinical practice. The current European~     Helicobacter Study Group Guidelines for the first line empirical treatment of the H. pylori~     infection propose a variety of treatment strategies, as optimal treatment of H. pylori~     infection requires careful attention to local antibiotic resistance and eradication~     patterns. Most recently, the Toronto Consensus for the Treatment of Helicobacter pylori~     Infection in Adults strongly recommended that all H. pylori eradication regimens now be~     given for 14 days. Recommended first-line strategies include concomitant nonbismuth~     quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole +~     clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth +~     metronidazole + tetracycline [PBMT]).The aforementioned statement by an international~     working group of specialists chosen by the Canadian Association of Gastroenterology is of~     the outmost importance, especially in countries with increased antibiotic resistance, like~     Greece, with resistance rates >20% to clarithromycin and >40% to metronidazole.~   "
7484|NCT02959242|"~     To assure the quality of follow-up and treatment, data of glaucoma patients are stored and~     evaluated after anonymisation.~   "
7485|NCT02959229|"~     The present study was designed to evaluate the effectiveness of oral lactoferrin in~     prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours)~     Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration~     on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy~     of prematurity and necrotizing enterocolitis.~   "
7486|NCT02959216|"~     This study evaluates the efficacy of aerobic exercise in the acute phase of recovery for~     pediatric patients with a concussion. Half of participants will complete sub-symptom~     threshold aerobic exercise and half of participants will complete a placebo stretching~     protocol.~   "
7516|NCT02958826|"~     The purpose of this study is to determine the effect surgical lights, surgical smoke, and~     surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.~   "
7530|NCT02958644|"~     Obese patients have a high level of intestinal microflora imbalance, with serious~     consequences such as loss of digestive function. Potential mediators of intestinal~     microbiota are prebiotics, supplements considered safe because they are naturally contained~     in food and human microbiota. Their use has been studied as new therapeutic approach for the~     regulation of intestinal microbiota in various situations of disease, including severe~     obesity.~      This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect~     of prebiotic supplementation (fructo-oligosaccharide - 12 g / day) on body mass index in~     participants with obesity class III, with follow up of 90 days.~   "
7487|NCT02959203|"~     Background:~      Insertion of a central venous catheter (CVC) could lead to a variety of complications.~      To detect those complications, Chest X-ray (CXR) is still the reference standard. However,~     there are major limitations in performing CXR's in the critical care setting.~      Aim/objectives:~      The objective of this study is to compare the use of bedside ultrasound (US) to conventional~     CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually~     replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement~     in critically ill patients, thereby reducing radiation exposure and unnecessary delay before~     CVC use.~      Methods:~      The bedside US will be performed by the student or attending physician, who is blinded for~     CXR findings. After US examination, the attending physician (or student) will fill in a~     structured form, based on an established protocol. CXR will be performed before or after US~     examination and assessed by a radiologist. The radiologist will be blinded for the findings~     of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after~     examination of the complete medical chart.~   "
7488|NCT02959190|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as Galcanezumab in Japanese participants with migraine.~   "
7489|NCT02959177|"~     The main purpose of this study is to determine the efficacy of the study drug Galcanezumab~     in Japanese participants with episodic migraine.~   "
7490|NCT02959164|"~     The purpose of this Phase 1b study is to assess the safety and maximum tolerated dose (MTD)~     of Decitabine in combination with Gemcitabine among previously treated patients diagnosed~     with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone).~   "
7491|NCT02959151|"~     The purpose of this study is to collect the date on the safety and potential effectiveness~     of CART cells combined with interventional therapy in patients with advanced liver~     malignancy.~   "
7492|NCT02959138|"~     The primary objective of this study is to evaluate the pharmacokinetics (PK) of GS-9876 in~     participants with impaired renal function relative to matched healthy controls. Participants~     in this study will be enrolled using an adaptive design that includes up to 3 enrolled~     cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in~     adaptive Cohorts 2 and/or 3.~   "
7493|NCT02959125|"~     This study evaluates the intervention of Nut Fish based food, micro nutrients~     supplementation and pregnancy class to improve maternal and birth outcome. This is cluster~     randomized trial with two arms. The intervention group will receive Nut Fish based~     supplementation, multiple micro nutrients, and pregnancy class. The control group will~     receive government food supplementation, iron folic acid supplementation, and pregnancy~     class.~   "
7494|NCT02959112|"~     Endoscopic retrograde cholangiopancreatography (ERCP) complications occur in 5 to 10% of~     cases, post ERCP pancreatitis is the most common, it is a complication with significant~     morbidity, occasional mortality and high costs. In the prevention of post-ERCP pancreatitis~     have been used various treatments, NSAIDs and pancreatic stent are the most useful, however,~     despite its use, post ERCP pancreatitis continues to affect 10 to 15% of patients with high~     risk. Epinephrine sprayed on the papilla may decrease the edema and prevent the development~     of this complication.~   "
7495|NCT02959099|"~     The ICONIC study is a retrospective, international, multicenter, nested case-control study~     based on propensity scoring methods to match patients with (Cases) and without (Controls) an~     acute coronary syndrome (ACS). Our objective is to identify atherosclerotic plaque~     characteristics (APCs) that may be implicated in future ACS and compare gender-specific~     disparities, if any, in coronary plaques among women and men who subsequently experience a~     future ACS. The primary outcome is an ACS comprised of ST elevation myocardial infarction~     (STEMI), non-ST elevation MI (NSTEMI), or unstable angina, and the secondary outcome of MI~     includes STEMI and NSTEMI only.~   "
7496|NCT02959086|"~     The purpose of this study is to describe the morbidity, mortality, disability and survival~     rate in Shanghai adolescents and children with cancer diagnosed since January 2002.~   "
7497|NCT02959073|"~     In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15%~     of the population suffers from cat allergy. Investigators perform this study in order to~     further investigate symptom records and their evaluation in cat allergic patients.~      Investigators primarily aim to better standardize the symptom recording of cat allergic~     persons under real-life conditions and to evaluate the effect of hypoallergenic cats on~     symptom strength.~   "
7498|NCT02959060|"~     This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of~     BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)~   "
7499|NCT02959047|"~     Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to~     atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify~     atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such~     techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab~     is a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on~     statins or intolerant to statins. The investigators hypothesize that effective low density~     lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will~     regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to~     placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be~     randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of~     Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in~     atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment~     period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff~     occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol,~     fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).~   "
7500|NCT02959034|"~     The aim of this project is to establish a bio-repository of diverse specimen types to~     provide investigators access to specimens in order to further research related to metabolism~     and the microbiome in the pediatric population.~   "
7501|NCT02959021|"~     The purpose of this study is to examine whether a primary care weight management~     intervention delivered by peer coaches produces greater weight loss than a self-directed~     program without peer coach support.~   "
7531|NCT02958631|"~     Comparison of blood pressure lowering effect between Fimasartan and Losartan in the~     hypertensive patient during night and early morning time~   "
7505|NCT02958969|"~     Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism~     (VTE) due to the disease itself and the use of targeted therapies, including~     immunomodulatory drugs (IMiDs). Prevention of VTE has become a major management challenge~     during MM treatment. There is a paucity of data with respect to the non-vitamin K oral~     anticoagulants (NOACs) in the cancer population. However, the NOACs offer comparable~     efficacy but improved safety compared with warfarin. Apixaban has shown excellent safety and~     efficacy for treatment and prevention of recurrent VTE (1,2). The safety and efficacy of~     apixaban for primary prevention of VTE in MM patients has not been established.~      Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in~     MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for~     primary prevention of VTE.~      Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM~     patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary~     prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher~     medical acuity than that of the previous large randomized controlled trials of apixaban, we~     will be selecting a stable population of MM patients who are appropriate for~     immunomodulatory therapy.~      Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are~     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.~      Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are~     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be <7% (3).~     Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating~     agents may further increase the risk of VTE, the rate of incident VTE should be reduced to~     <7% with apixaban.~   "
7506|NCT02958956|"~     The purpose of this study was to evaluate whether treatment with pioglitazone is associated~     with risk of incident cancer at the 10 most common sites in a cohort of participants with~     recognized diabetes.~   "
7507|NCT02958943|"~     Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely~     available risk stratification tools, five options for oral anticoagulation, and~     evidence-based practice guidelines, anticoagulation for stroke prevention in AF is~     consistently under-prescribed. Data from our center (Brigham and Women's Hospital [BWH]) (1)~     demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to~     2012 Focused Update of the European Society of Cardiology Guidelines for the Management of~     AF (2) receive anticoagulation.~      Aim #1: To determine the impact of electronic alert-based computerized decision support~     (CDS) on prescription of anticoagulation in high-risk AF patients in the outpatient setting~     who are not being prescribed anticoagulation for stroke prevention.~      Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by~     80% in high-risk AF patients in the outpatient setting who are not being prescribed~     anticoagulation for stroke prevention.~      Aim #2: To determine the impact of electronic alert-based computerized decision support~     (CDS) on the frequency of stroke and systemic embolic events in high-risk AF patients in the~     outpatient setting who are not being prescribed anticoagulation for stroke prevention.~      Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic~     embolism in high-risk AF patients in the outpatient setting who are not being prescribed~     anticoagulation for stroke prevention. Data acquired through this study regarding the~     frequency of stroke and systemic embolism will be used to calculate sample size requirements~     for a future clinical end-point driven randomized controlled trial of electronic alerts to~     prevent stroke in high-risk AF patients.~   "
7508|NCT02958930|"~     The purpose of this study is to determine the safety and initial efficacy of Transcranial~     Electromagnetic Treatment (TEMT) in patients with mild/moderate Alzheimer's Disease.~     Throughout a 2-month treatment period, patients will be evaluated for cognitive performance,~     brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF)~     markers for Alzheimer's Disease. Since all patients will receive TEMT, each patient's~     baseline measurements will serve as their own control for any treatment effects.~   "
7509|NCT02958917|"~     Patients are being offered participation in this pirfenidone trial because They have been~     diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung~     disease (ILD). This is a disease where scarring of lung tissue occurs as the result of~     inhaling substances called antigens. These antigens can be substances such as molds,~     chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen~     into the bloodstream to reach other organs.~      Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This~     drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic~     Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your~     condition. The use of pirfenidone has not been approved for the treatment of FHP. It is~     considered experimental treatment in this study.~   "
7510|NCT02958904|"~     Aims: assess the relationship between sexual function and depressive symptoms in individuals~     with spinal cord injury.~   "
7511|NCT02958891|"~     An epidemiological survey for prevalence description of dental morbidity (caries,~     gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits.~     Morbidity measures were collected from 700 recruits at their first day of military service~     in order to evaluate extent and burden of dental diseases among recruits. The data will~     enable the military dental services commanders to plan and implement dental services~     according to the dental needs.~   "
7512|NCT02958878|"~     Double blinded, randomized controlled prospective study looking at 2 preoperative doses of~     Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A~     previous study was conducted called Effectiveness of tamsulosin inprevention of~     postoperative urinary retention: a randomized double-blind-placebo controlled study This~     study involved a tertiary care center involving mostly urological surgical procedures. We~     look to specifically look at inguinal hernia surgeries in males. The aim of this study is to~     compare the prophylactic effect of tamsulosin with placebo on postoperative urinary~     retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention.~     It is on formulary at Genesys. Currently there is no standard procedure of prophylactic~     tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to~     augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary~     retention post operatively. We often straight catheterize patients once and start tamsulosin~     with the goal of avoiding urinary retention and future straight catheterizations or~     placement of foley catheters~   "
7513|NCT02958865|"~     The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective~     in treatment of moderate to severe ulcerative colitis.~   "
7514|NCT02958852|"~     A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to~     Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment~     (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.~   "
7515|NCT02958839|"~     To investigate whether fibroblast growth factor 23 can be used to predict recurrence after~     catheter ablation for atrial fibrillation and to provide an objective basis for the clinical~     selection of the optimal patients for catheter ablation.~   "
7517|NCT02958813|"~     This study has three specific aims:~        1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health~          program (FUELTM). The investigators will:~           a. Randomly assign 300 14-18 year-old AA or black girls and their primary female~          caregivers to IMARA (N=150) or FUELTM (N=150). Women and girls will be recruited four~          ways: 1) from mental health clinics using clinic liaisons, 2) flyers will be posted in~          clinic recruitment sites and other agencies instructing interested families to call our~          recruiter, 3) IMARA participants will hand flyers to interested women and girls they~          know, and 4) COIP field station staff will pass out flyers and recruit interested women~          and girls at the field stations and in the community. Investigators will examine the~          effects of IMARA on women and girls' sexual behavior at 6- and 12-months.~        2. To evaluate the impact of IMARA on theoretical mediators posited by the Theory of~          Gender and Power and the Social-Personal framework associated with AA women and girls'~          risky sex. Investigators will:~             1. Assess changes in women and girls' Individual Attributes (HIV/AIDS knowledge,~               attitudes, and beliefs, mental health/emotion regulation, ethnic identity); Peer~               and Partner Processes (partner characteristics, relationship power dynamics, peer~               influences, partner communication); and Family Context (mother-daughter~               relationship and communication, parental monitoring) at baseline and follow-ups.~             2. Evaluate mediation and moderation of theoretical mechanisms on women and girls'~               sexual behavior.~        3. To assess the impact of IMARA compared to FUELTM on sexually transmitted infections~          (STIs). Investigators will:~             1. Test women and girls' urine for three common STIs at baseline and 12-month follow~               up.~             2. Explore linkages between biological outcomes and targeted mediators and moderators~               of change.~   "
7518|NCT02958800|"~     Aggressive behaviours in long-term care (LTC) is a difficult health care issue to manage.~     One method that has been over-used is the prescription of antipsychotics for the behaviours~     and psychological symptoms of dementia (BPSD). This high prevalence of use is a recognized~     health care problem in Ontario and around the world; increased antipsychotics use is~     associated with increased falls and mortality. Existing strategies are educational in nature~     and are not systematic; the goal of this study is to develop a systematic algorithm to help~     LTC physicians deprescribe and taper antipsychotics safely and effectively.~      The objectives of the study is to: 1) Develop a discontinuation algorithm for antipsychotics~     based on single patient open-label (SPOT) trial methodology (e.g. a variation of N-of-1~     trials) with standardized outcome measures for LTC physicians; 2) To pilot a clinical~     pharmacist-led recruitment strategy; 3) To provide preliminary evidence to demonstrate that~     this algorithm could lead to deprescribing of anti-psychotic medications in LTC.~   "
7519|NCT02958787|"~     Prostate cancer patients have a number of excellent treatment options to consider, and~     quality of life following treatment is often a consideration in treatment choice. One~     critical quality of life concern for patients diagnosed with prostate cancer is sexual~     function. Previous studies point to a vascular mechanism of impotence post-radiation~     therapy, as opposed to a nerve-based mechanism following surgery. In this study, the~     critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by~     MRI-based imaging and included in treatment planning for radiation treatments, hopefully~     preserving critical artery function. This study will collect erectile function preservation~     rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient~     reported using the simplified three-question erectile function scale.~   "
7520|NCT02958774|"~     The primary objective of this study is to determine whether lymphedema rates are decreased~     in patients requiring regional nodal irradiation (RNI) who receive hypofractionated~     radiation as compared to conventional radiation.~   "
7521|NCT02958761|"~     Primary aim of this trial was to assess efficacy three intraarticular injections of platelet~     lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment~     groups in terms of a number of functional scales and of number of adverse events.~   "
7522|NCT02958748|"~     To evaluate change of different immune cellsduring ARDS and its impact on prognosis.~   "
7523|NCT02958735|"~     The purpose of this study is to determine whether an acute bout of exercise may temporarily~     enhance cognitive function (such as memory or attention span) by measuring behavioral~     performance on cognitive tests, as well as expression of hormones in circulation associated~     with brain plasticity and stress.~   "
7524|NCT02958722|"~     The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for~     suspected uterine pathologies. Women will be randomized into two groups on the basis of~     distension medium : group A CO2; group B physiological solution. Pain discomfort will be~     evaluated after the examination.~   "
7525|NCT02958709|"~     In this open-labeled, randomized clinical trial, the Investigator will assess the safety and~     pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without~     levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous~     meningitis (TBM) versus standard treatment. The Investigators will also assess functional~     and neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin~     Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.~   "
7526|NCT02958696|"~     HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label,~     randomised, crossover, single dose, trial in healthy volunteers to compare the relative~     bioavailability of HTL0018318 when given by oral aqueous solution and in capsule~     formulation.~   "
7527|NCT02958683|"~     Breathing movements, called chest wall motion, are very complex. The investigators are~     studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how~     this differs with different diseases in the chest. Breathing movements may help with~     diagnosis, assessment of severity or assessing the impact of treatments for chest~     conditions. The investigators are following people who have a chest disease, measuring their~     chest wall motion and comparing it to their diagnosis and and how their treatment works.~      Chest wall motion can be measured in different ways at rest and whilst exercising. Small~     stickers on the chest can be used to reflect infra red light or visible squares of light can~     be shone onto the chest without using stickers.~   "
7528|NCT02958670|"~     Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease~     pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the~     ability to study tau protein deposition in vivo in subjects, in which information on~     cerebral amyloid deposition has already been gathered. This enables to study effects of tau~     deposition on neuronal integrity, their relation to effects of beta-amyloid deposition and~     how this contributes to cognitive impairment or well-being in the elderly.~   "
7529|NCT02958657|"~     This project aims to evaluate, in recent post-acute myocardial infarction (AMI) patients on~     dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability~     and the correlation between the level of platelet aggregability and muscle sympathetic nerve~     activity (MSNA).~   "
7549|NCT02958397|"~     The overall purpose of this study is to explore the therapeutic effect of CD33-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.~   "
7532|NCT02958618|"~     Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in~     treating common bile duct stones. It had the similar success rate of stone extraction, but~     its incidence of complications remained uncertain. However, there is no clinical evidence~     and guideline to define the optimal duration of balloon dilation so far. So we designed a~     prospective randomized trial to compare the effect of three different duration of balloon~     dilation during ESBD so that we can find the optimal duration of the balloon dilation.~   "
7533|NCT02958605|"~     Medication errors are common in children. Characteristics of errors during critical~     situations in the Emergency Department are ill-defined and might be more frequent than~     previously thought. However, optimal strategies to eliminate the risk of prescribing errors~     remain unknown.~      Many smartphone apps have been suggested over the last years with some of them designed to~     calculate medication dosage for children. The impact of these apps to decrease dosage error~     has never been evaluated in resuscitation setting.~      The aim of the study is to evaluate whether the use of a smartphone application designed to~     calculate medication doses decreases prescribing errors among residents during pediatric~     simulated resuscitations.~      This will be a crossover-randomized trial using high fidelity simulation among 40 residents~     rotating in the pediatric emergency department.~   "
7534|NCT02958592|"~     To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for~     staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors~     before hepatic resection, using resected tissue pathology as a reference standard.~   "
7535|NCT02958579|"~     Metabolic syndrome (MetS) is recognized as clustering of a number of components including~     hypertension, hypertriglyceridemia, low serum high-density lipoprotein cholesterol (HDL-C),~     impaired glucose metabolism (IGM), and abdominal obesity. It has been tightly linked to~     thrombotic vascular events including coronary heart disease (CHD). Worldwide prevalence of~     MetS is on the rise. People living in Iran, a country located in the Middle-East region,~     have distinct behavioral, environmental and social exposures which certainly affect the~     prevalence and incidence of metabolic syndrome and its comorbidities.We hypothesized that~     these factors may affect the course of metabolic syndrome and the burden that it imposes to~     the community. The purposes of MetSCoM are as follows;~        1. To find the incidence of T2D, microvascular complications of T2D (diabetic retinopathy,~          diabetic neuropathy and diabetic kidney disease), CVD, and mortality rate of subjects~          metabolic syndrome.~        2. To find the association of baseline, mean value during follow up visits and visit to~          visit variability in anthropometric variables and several metabolic laboratory~          variables with metabolic syndrome and its complications.~        3. To find the effect of behavioral variables and environmental exposures on the course of~          metabolic syndrome.~        4. To identify the best anthropometric, laboratory, life-style and environmental~          predictors of CVD and mortality rate in subjects with metabolic syndrome.~        5. To estimate the economic burden of metabolic syndrome and its related~   "
7536|NCT02958566|"~     The General Objective of this study is to investigate the cost and efficacy of treating~     patients undergoing colorectal surgical resections with an opioid limited pain control~     regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be~     compared to a traditional opioid based pain control regimen.~   "
7537|NCT02958553|"~     A study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in~     active seniors.~   "
7538|NCT02958540|"~     The study is a double-blind (within dose level), placebo-controlled Phase I study to assess~     the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low~     dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs),~     each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day~     29. The two dose levels will be recruited sequentially.~      Immunogenicity end-points will include assessment of humoral and cellular responses at~     selected time-points.~   "
7539|NCT02958527|"~     SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL~     PRACTICE~   "
7540|NCT02958514|"~     This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused~     by meibomian gland dysfunction and make a comparison between the traditional treatment.~   "
7541|NCT02958501|"~     The purpose of this study is to confirm anticipated substitution dose of the vitamin D for~     sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)~   "
7542|NCT02958488|"~     The main objective of the study is to gather preliminary data on the effectiveness of High~     Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in~     newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).~      The secondary objective is to evaluate the safety of HFNC in this indication.~   "
7543|NCT02958475|"~     This study is being conducted to evaluate the breastfeeding support program utilizing~     bilingual English-Spanish tailored text messages and online support to support exclusive and~     continuous breastfeeding for new mothers--comparing texting alone, texting with an online~     support group to those with usual care. The cost involved in moderating the online groups~     and providing bidirectional consultation when needed will be evaluated and qualitative~     feedback from a subset of mothers in both intervention groups will be evaluated to determine~     what was effective, as well as suggestions for improvement of the messaging program.~   "
7544|NCT02958462|"~     The use of genomics and functional translational studies is to identify and diagnose~     patients with precursor features of myeloid neoplasms and inherited bone marrow failure~     syndromes.~   "
7545|NCT02958449|"~     Comparing standard wound closure technique with drains (control) to standard wound closure~     techniques with TissuGlu® and no drains (test) in mastectomy~   "
7546|NCT02958436|"~     The primary object of this study is to evaluate the safety and tolerability of single~     ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males~     and females~   "
7547|NCT02958423|"~     The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current~     stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the~     spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients~     suffering of endometriosis-related chronic pelvic pain (CPP)~   "
7548|NCT02958410|"~     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of lymphocyte derived~     malignancies.~   "
7551|NCT02958371|"~     Previous studies have suggested that consumers who can choose what to eat could find food~     more pleasant, and consume more of that food, than when in absence of choice. However~     cognitive mechanisms that could explain the effect of choice have not been investigated. The~     study consists in a fMRI experiment intended to observe the effect of the presence of choice~     on brain activity following consumption of a fruit-flavored drink, compared to the brain~     activity when the same drink is consumed without choice. It is suggested that consumers will~     appreciate drinks they chose better, and that the activity in gustatory and reward regions~     will change accordingly to changes in declared food pleasure.~   "
7552|NCT02958358|"~     The investigators are doing this research study to find out how blood flow changes in the~     lungs of people with pulmonary hypertension before and after treatment with ambrisentan~     (sold under the brand name Letairis). The investigators hope that knowing about these~     differences will help us to better understand pulmonary hypertension and find new ways to~     diagnose it earlier.~   "
7553|NCT02958345|"~     Study Design:~      Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.~      Subjects will receive either Zostavax or placebo and will be followed for four months.~      Hypothesis:~      The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic~     patients like that seen in elderly patients.~   "
7554|NCT02958332|"~     Aims: To demonstrate the effect of a program based on video games as a means to improve~     abilities and basic skills affected by lymphedema, and its impact on quality of life.~      Design: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor~     blinded study.~      Method: Data on shoulder pain and disability, health-related quality of life, strength and~     articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability~     Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer),~     respectively goniometry and dynamometry amplitude scales will be collected.~      The intervention will be performed with the Wii ™ console and the Wii Balance BoardTM,~     during 5 individual weekly sessions of 30 minutes.~   "
7555|NCT02958319|"~     Patients with rheumatoid arthritis with positive antibodies against carbamylated proteins~     (anti-CarP) have a more severe clinical course. The primary objective of this study in adult~     subject with RA is as follows: To explore the clinical differences in activity indexes~     (DAS28-ESR) at 6, 12 and 18 months of follow up according the anti-CarP status.~   "
7556|NCT02958306|"~     The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of~     unilateral cleft lip repair.~   "
7557|NCT02958293|"~     This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC)~     database to evaluate if there are any differences in perioperative morbidity for elective~     surgery based on the time of the year surgery is performed.~   "
7558|NCT02958280|"~     The purpose of the study twofold: first, a smartphone-based physical activity application~     (app), which will be called Fit&Sober, will be developed and tailored specifically for~     patients with alcohol use disorders (AUDs); then, the feasibility, acceptability, and~     short-term increases in physical activity with the use of the Fit&Sober app will be examined~     over the course of a 12-week intervention.~   "
7559|NCT02958267|"~     The purpose of this study is to determine the clinical response to autologous bone marrow~     aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee~     osteoarthritis with respect to pain, function, and quality of life at up to 1 year following~     the intervention. Specifically, the clinical response will be compared to baseline and a~     control group treated with a Gel-One® hyaluronate injection to the target knee.~   "
7560|NCT02958254|"~     No previous studies have compared the association between muscle thickness (MT) and muscle~     cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to~     investigate the validity of ultrasound in assessing the muscle thickness of hamstrings~     muscle.~      Study design:~      A cross-sectional-validity study.~      Setting:~      University~      Participants:~      X football players of an amateur football team (X healthy volunteers and X patients with a~     previous hamstring injury).~   "
7561|NCT02958241|"~     This study investigates the possible differences in images obtained in patients with lumbar~     spondylolisthesis when positioned in an upright weight bearing position compared with~     traditional supine positioning for lumbar MRI.~   "
7562|NCT02958228|"~     The purpose of this randomized controlled trial is to establish feasibility and provide~     initial estimates of efficacy of two computerized cognitive training procedures (a form of~     Positive Mental Imagery Training, PMIT, and a form of Cognitive Control Training, CCT)~     delivered as adjuncts to treatment as usual (TAU) in inpatient mental health treatment~     settings.~   "
7563|NCT02958215|"~     Pregnant women with a positive preoperative Supine stress test were found to be a subgroup~     at increased risk of symptomatic hypotension after spinal anesthesia~   "
7564|NCT02958202|"~     The aim of this study is to provide continuing access to BMN 044 treatment for subjects~     previously treated with BMN 044. The information gained from this study is expected to~     further characterize the efficacy and safety of BMN 044 over a longer treatment period.~   "
7565|NCT02958189|"~     The purpose of this study is to determine whether a Twitter-based intervention with a~     private, online support group can significantly increase number of walking steps compared to~     self-monitoring of physical activity alone or a control group in sedentary women at a~     women's heart clinic.~   "
7566|NCT02958176|"~     Low resting heart rate variability (HRV) has been associated with sexual arousal problems~     and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads~     to increases in HRV as well as improvements in symptoms associated with several~     psychological disorders, some of which are comorbid with sexual arousal problems in women.~     Autogenic training also facilitates increases in HRV and was recently associated with acute~     increases in sexual arousal among sexually healthy women. The primary aim of the current~     study is to examine the efficacy of HRV biofeedback, with and without autogenic training,~     for the treatment of female sexual arousal disorder (FSAD).~   "
7620|NCT02957474|"~     This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to~     compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after~     co administration with omeprazole, a proton pump inhibitor.~      The study will consist of a screening phase, a baseline phase, four treatment periods, and a~     follow up phone call five days (± 1 day) after discharge.~   "
7567|NCT02958163|"~     This will be multicentre a phase II randomized controlled and open-label trial. It will~     compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead~     Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic~     Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.~      This trial will also include one substudy. This substudy will confront the~     immuno-histochemical results collected on tumoral biopsies to the biological and imaging~     (MRI) results. Every patient participating to the trial can also participate to this~     substudy.~   "
7568|NCT02958150|"~     This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and~     the different strategies routinely used in patients with ARF of different aetiologies.~     Efficacy will be assessed based on absence of intubation, short term prognosis, and~     occurrence of medical complications.~   "
7569|NCT02958137|"~     Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT~   "
7570|NCT02958124|"~     The purpose of this study is to evaluate the feasibility and the security of early~     mobilization of infants in pediatric intensive care.~   "
7571|NCT02958111|"~     This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this~     study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant~     chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).~   "
7572|NCT02958098|"~     The My Research Legacy Pilot Study will establish a participant registry that collects~     self-reported health data and answers to online survey questions about individual daily~     choices, diets, and exercise; data from wearable devices; and, (optional) data from genome~     sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will~     answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check~     v4.0 three times over the course of 6 months, transmit data from a Fitbit Charge 2 device,~     and (optional) provide a saliva sample for whole genome sequencing.~   "
7573|NCT02958085|"~     This trial is conducted in The United States of America. The aim of this trial is to~     investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the~     body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple~     Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.~   "
7574|NCT02958072|"~     An International Multicenter study evaluation, off the effect of the fully autologous growth~     factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers in patients~     with diabetes.~      To compare the impact of LeucoPatch as part of usual care in multidisciplinary Diabetes Foot~     clinic settings, versus usual care in the same clinics on malleoli ulcers healing.~   "
7575|NCT02958059|"~     Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that~     allows minimally invasive management of biliary and pancreatic disorders. However, the~     incidence of infectious complication of ERCP is considerable. Transient blood stream~     infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection~     accounts for about 10% of the major complications associated with mortality.~      Although prophylactic use of antibiotics is generally not recommend in all cases, debates~     about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is~     recommend in case of ERCP that incomplete biliary drainage is expected.~      In this study, researchers will use prophylactic antibiotics in patients with biliary~     obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected~     based on the data of our institution, and administered to patients before ERCP procedure.~   "
7576|NCT02958046|"~     The purpose of this study is to investigate the efficacy of lansoprazole combination with~     domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance~     kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).~   "
7577|NCT02958033|"~     In this study,the eligible breast cancer patients will be randomized divided into two~     groups. the study group receive the accelerated hypo-fractioned whole breast irradiation~     with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control~     group receive conventional fractioned whole breast irradiation with a concurrent boost to~     the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by~     external beam-intensity modulated radiotherapy. the purpose of this study is to assess~     whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated~     radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including~     breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.~   "
7578|NCT02958020|"~     This is a multicenter cohort study on osteoporosis in six cities of China which locate in~     the east, south, north, west, middle of China respectively. At least 3000 middle-aged and~     elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every~     city were enrolled. Residents with severe mental diseases, physical diseases or acute~     infectious diseases who could not cooperate with the survey as well as lactating or pregnant~     women were excluded. All the enrolled residents who signed informed consent will finish~     questionnaire including demographic characteristics, history of smoking, alcohol drinking,~     falls and fracture, family, chronic diseases and medicine,diary and physical practice.~     Osteoporosis risk, health status (EQ-5D) and constitution of traditional Chinese medicine~     (TCM) will be evaluated. Fasting blood tests, bone mineral density and physical examinations~     (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue~     coating and pulse) will be performed at enrollment and every two years after enrollment. DNA~     of blood cells will be preserved.~   "
7579|NCT02958007|"~     Older adults with psychotic disorders experience a dual set of challenges: those related to~     serious mental illness, and those related to aging. They have medical, cognitive,~     psychological and social difficulties; as a result they have an almost four times greater~     likelihood of early institutionalization in nursing homes. These challenges make it~     difficult for this group to engage in health behaviors, such as exercise. This is~     unfortunate, since participation in health-promoting activities is essential for maintaining~     functional independence with age. This study aims to develop and pilot test a peer coaching~     intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who~     are Veterans in recovery from mental illness, will provide intensive coaching to older~     Veterans with psychotic disorders to promote their participation in exercise and physical~     activity. Results from this study will inform us as to whether this intervention is~     acceptable to Veterans, feasible to implement, and effective in increasing exercise,~     physical activity, and physical fitness/function.~   "
7581|NCT02957981|"~     The primary goal of this research is to develop and test a web-based genetic~     education/counseling intervention. This intervention is designed to educate men from~     hereditary cancer families about the personal relevance of genetic testing in order to help~     them make decisions about whether to pursue genetic testing. The investigators will test~     this intervention against standard care for men from hereditary cancer families. The~     web-based educational intervention includes all of the information typically covered during~     genetic counseling. As a result, after completing the education intervention participants~     can proceed directly to genetic testing if they choose. The investigators will conduct a~     survey prior to randomization and then follow-up surveys at 1-month and 6-months~     post-randomization. The primary outcome will be uptake of genetic testing. Secondary~     outcomes will be completion of genetic counseling and decision satisfaction.~   "
7582|NCT02957968|"~     This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of~     immunotherapy consisting of sequential decitabine followed by pembrolizumab administered~     prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced~     HER2-negative breast cancer. The primary efficacy objective is to determine if the~     immunotherapy increases the presence and percentage of tumor and/or stromal area of~     infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy~     will be evaluated in 2 cohorts based on hormone receptor status.~   "
7583|NCT02957955|"~     This study evaluates the addition of high-intensity interval training to the standard~     pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one~     arm will receive high-intensity interval training, and the other arm will be encouraged to~     remain physically active, although they do not participate in a regular structured exercise~     training program.~   "
7584|NCT02957942|"~     Focal dystonia is a neurological movement disorder characterized by excessive involuntary~     muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia~     characterized by excessive contraction of intrinsic muscles in the larynx, leading to~     difficulty in speaking and affecting effective communication. The cause of SD is unknown and~     there are no treatments that produce long-term benefits. Previous studies have suggested~     that SD and other focal dystonias are associated with decreased inhibition in sensorimotor~     areas in the brain. However, no studies have investigated the effects of modulating~     excitability of the laryngeal motor cortex in healthy individuals or SD. The goal of this~     pilot project is to determine if brain excitability of the laryngeal motor cortex can be~     changed with low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in~     individuals with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz)~     produces lasting inhibition in the brain, and that SD is associated with decreased cortical~     inhibition, the purpose of this pilot study is to determine safety, feasibility and response~     to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The~     results will help understand changes associated with the disorder, as well as contribute to~     the development of future clinical interventions for SD.~   "
7585|NCT02957929|"~     This is a Phase l double-blind, placebo-controlled, randomized study to investigate the~     safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of~     APX001 administered intravenously and orally, followed by an evaluation of the safety,~     tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of~     APX001 administered orally.~   "
7586|NCT02957916|"~     In order to better understand early onset obesity and to identify patients in interested in~     future research studies, including clinical trials, we aim to develop a registry for~     patients with early onset obesity.~   "
7587|NCT02957903|"~     The purpose of this study is to investigate and describe the anatomical distribution of the~     sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to~     the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine~     whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be~     conducted in healthy volunteers in a blinded, randomized paired study.~   "
7588|NCT02957890|"~     This study evaluates the immunogenicity of adding inactivated influenza vaccine with~     southern hemisphere (SH) formulation to standard once-annual influenza vaccination with~     northern hemisphere (NH) formulation in older adults in Hong Kong over 5 years. Half of~     participants will receive twice-annual influenza vaccination with NH and SH formulation,~     while the other half will receive once-annual influenza vaccination with NH formulation and~     a placebo.~   "
7589|NCT02957877|"~     There is a lack of data in the literature about the use of low-molecular weight heparin~     (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to~     evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to~     unfractionated heparin as anticoagulation for NHHD treatment.~   "
7590|NCT02957864|"~     Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV.~     Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new~     pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be~     a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is~     another drug that can be used for the treatment of HIV and is not associated with renal~     toxicity.~      In this study the investigators will compare the effect on renal function of a switch from~     TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.~   "
7591|NCT02957851|"~     To assess the effect of 3 consecutive days of one-hour administration of Nitrous~     Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical~     air), in add-on therapy to chronic analgesic treatments, on average pain intensity in~     patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be~     included in all the participating centres, i.e., 125 randomised patients in each of the 2~     study groups treatments~   "
7592|NCT02957838|"~     The purpose of this crossover study is to determine whether nutritional supplementation of~     C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We~     will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics.~     Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a~     bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells~     will be scored by immunofluorescence and FACS analysis.~   "
7621|NCT02957461|"~     This study is designed to validate the performance of the algorithms to be used in future~     commercial device.~   "
7594|NCT02957812|"~     The purpose of this study is to explore the long-term effects that orthotics imposes on the~     structure and function of the foot. The objectives of the study are to determine if the use~     of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar~     intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar~     intrinsic muscles and (c) creates any changes in balance control during gait termination.~     The aim of the study is to enhance the appropriate dispensing of orthotics, and whether~     additional measures, such as rehabilitation exercises are necessary to increase their~     overall effectiveness in the clinical setting.~   "
7595|NCT02957799|"~     The purpose of this study is to address the United States Office of AIDS Research highest~     priorities: improving the workforce, reducing health disparities, and addressing HIV~     comorbidities. UCLA will randomize 24 of the government-funded community health workers~     (CHW) in matched rural areas in the Eastern Cape in South Africa to either: 1) the~     Accountable Condition (AC) in which additional monitoring and accountability systems that~     Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani~     training, but ongoing supervision and monitoring consistent with local government practices.~   "
7596|NCT02957786|"~     To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural~     support compared to varenicline plus behavioural support for smoking cessation, in~     indigenous Māori (or family of Māori) who smoke and are motivated to quit.~   "
7597|NCT02957773|"~     This project will be a randomised controlled trial to investigate the effectiveness of an~     integrated programme by using social art activity (SA) and exercise, for instance, Qigong~     (QG, a traditional Chinese exercise) as a therapeutic medium.~      This integrated programme aims to increase the well-being and reduce the depressive symptoms~     that are frequently ascertained in older people who live in nursing homes. The combination~     of SA and QG might be more beneficial to older people than either individual activity on its~     own, given that they are addressing different areas of functioning. The art activity focuses~     on self-expression in non-verbal activity using fine motor movement, whereas physical~     exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to~     help the older person achieve mental and physical relaxation by using gross motor movement.~     When the interventions are combined by utilising Qigong ahead of the art activities (thus,~     including both fine and gross motor movements) older people will reach a state of mental and~     physical relaxation, and moreover, will be able to express their feelings more simply in the~     social art activities.~   "
7598|NCT02957760|"~     The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in~     particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is~     no effective systemic treatment of this condition. An increase in the adhesion of~     erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with~     overexpression of membrane phosphatidylserine~   "
7599|NCT02957747|"~     Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to~     attempted or completed rape) is a significant social and public health problem among women~     Veterans. For women Veterans, lifetime ST can occur prior to, during or after military~     service. ST is associated with multiple difficulties and risks, including posttraumatic~     stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an~     effective, integrated, and low-cost intervention that targets ST-related risks for women~     Veterans with lifetime ST would advance clinical care for these vulnerable women.~      This research will develop and assess a computer-delivered intervention (Safety and Health~     Experiences Program; SHE) that will provide a screening and brief behavior intervention for~     women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address~     interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and~     PTSD). SHE will be designed to provide individualized assessment, feedback, and referrals~     for women Veterans with any lifetime ST. SHE will take place within a primary care setting.~     Primary care visits are frequent points of health care contact for women Veterans making the~     visit itself the ideal, and possibly only, opportunity to provide behavioral interventions.~      This study will lay the groundwork for a larger clinical trial of the SHE program in~     multiple VA primary care settings. If effective, the intervention, SHE, represents an~     innovative and low cost service for early identification and intervention that could be~     implemented nationwide with ease and speed to address the needs of women Veterans with~     lifetime ST. The long-term goal of the project is to make a significant impact on advancing~     health services research by introducing and testing a novel and potentially powerful service~     tool that may improve service delivery to address the co-occurring health concerns for women~     Veterans with any lifetime ST.~   "
7600|NCT02957734|"~     LAVA Ultimate composite restorations will be used as restorative material to reconstruct~     severely worn dentitions.~   "
7601|NCT02957721|"~     The following are hypothesized:~        1. The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary~          care workflow to facilitate the care of patients with type 2 diabetes.~        2. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.~        3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self~          management and glucose control~   "
7602|NCT02957708|"~     This study examines the effect of combining modified constraint-induced movement therapy~     (mCIMT) and self-regulation (SR) in promoting upper limb function of children with~     hemiplegic cerebral palsy (CP) studying in a school-based setting.~   "
7603|NCT02957695|"~     In this randomized double-blind controlled study we would like to test the benefit of~     neurofeedback for the recovery of patients with frontal brain injury during an early stage~     of neurorehabilitation.~   "
7604|NCT02957682|"~     The main purpose of this study is to evaluate the effect on mental state (known as~     neurocognitive function) with use of Praluent.~   "
7605|NCT02957669|"~     The purpose of the study is to determine the impact of the offer to participate in the~     Practice Self-Regulation (PS-R) (treatment) relative to the offer to participate in the~     Therapy Practice Group (control) on increasing knowledge of sexual health and the impact of~     trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors nine~     months after the end of treatment.~   "
7606|NCT02957656|"~     The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9~     pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9~     pandemic inactivated influenza vaccine (H7N9 pIIV).~   "
7607|NCT02957643|"~     The purpose of the study is to investigate the effectiveness of iron in the treatment of~     iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the~     hemoglobin, hematocrit and iron in serum and assess the course of treatment.~   "
7608|NCT02957630|"~     The proposed study will provide an assessment of the effect of this combination on endocrine~     function, metabolic control and hemostasis during 6 treatment cycles. This will be compared~     to the effects of two reference COCs.~   "
7622|NCT02957448|"~     This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of~     BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)~   "
7609|NCT02957617|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A~     secondary objective is to investigate the maintenance of effect during long-term treatment~     with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline~     will be prior to randomization into Study 1014802-203. Another secondary objective is to~     evaluate the impact of treatment with BIIB074 on quality of life (QoL).~   "
7610|NCT02957604|"~     This is a prospective observational registry study to evaluate fetal, infant and childhood~     outcomes in women exposed to evolocumab during pregnancy~   "
7611|NCT02957591|"~     Recent research demonstrates that the composition of the gut microbiome is a master~     regulator of key neurophysiological processes that are affected in depression. Indeed,~     contemporary studies showed that faecal microbiota is altered in patients with major~     depressive disorder (MDD). Furthermore, it has also been shown that supplementation of~     probiotics ameliorated depressive symptoms in unmedicated patients with mild to moderate~     depression. However, no study has yet explored the efficacy of a probiotic-based therapy in~     patients with severe MDD in addition to a standard antidepressant treatment. As dietary and~     lifestyle interventions may be a desirable, effective, pragmatical and non-stigmatizing~     prevention and adjuvant therapy (in addition to antidepressant treatment) in depression,~     this project is aimed at investigating for the first time if probiotic supplementation~     compared to a placebo treatment improves the effect of standard antidepressant medication on~     depressive symptoms (i.e. better and faster remission) in patients with severe MDD.~     Furthermore, this study will further test if probiotic supplementation modulates immune~     signalling and inflammatory processes (macrophage migration inhibitory factor and~     interleukin 1 beta), hypothalamic-pituitaryadrenal (HPA) axis responses (saliva cortisol),~     neurogenesis (brain-derived neurotrophic factor (BDNF) expression), the release of~     appetite-regulating hormones (leptin and ghrelin), the composition of gut microbiota (in~     particular levels of Enterobacteriaceae, Alistipes and Faecalibacterium) and brain~     perfusion, structure and activation and if these changes are associated with the~     probiotic-induced effect on depressive symptoms.~   "
7612|NCT02957578|"~     This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes~     with the AventaMed Solo Tympanostomy Tube Device (TTD)~   "
7613|NCT02957565|"~     The goal of this research study is to learn how patients feel about their doctors' attitudes~     toward supportive care and treatment options for advanced cancer patients.~   "
7614|NCT02957552|"~     Since the introduction of calcineurin-based immunosuppression, patient and graft survival in~     pediatric liver transplantation (LT) improved significantly. However, in contrast,~     calcineurin inhibitor (CNI) toxicity leads to significant morbidity and impairs quality of~     life for recipients. Moreover, CNI cannot prevent long-term allograft inflammation and~     fibrosis.~      Mesenchymal stem (stromal) cells (MSC) have potent immunomodulatory properties potentially~     promoting allograft tolerance and ameliorating toxicity of exposure to high dose CNI.~     Previous trials for non-solid organ transplant indications have shown an excellent safety~     profile of intravenous MSC application. The MYSTEP1 trial aims to investigate safety and~     benefits portal and intravenous MSC infusion in pediatric LT.~   "
7615|NCT02957539|"~     Three of every four Veterans are overweight or obese, and weight loss is associated with~     reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately~     effective but only reaches a small percentage of overweight Veterans. This proposed study~     will test whether a patient incentive program that gives Veterans non-financial incentives,~     such as Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is~     effective. An effective patient-incentive program could help more Veterans lose weight~     without requiring a substantial increase in VA staff.~   "
7616|NCT02957526|"~     The purpose of this study will be to test the use of a web-based mobile application (app)~     initiated at the time of hospital discharge to provide real-time monitoring and better~     management of treatment-related adverse symptoms among patients with hormone-receptor~     positive breast cancer and a new aromatase inhibitor prescription.~   "
7617|NCT02957513|"~     The overall goal of this study is to compare how well motivational messages (text messages~     from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes~     education materials (provided at the doctor's office) work to help African-American adults~     with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is~     difficult when you have diabetes, especially when patients have other medical conditions,~     their diabetes is uncontrolled, and when they live in an area without many primary care~     doctors. Many studies have show that encouraging text messages from the doctor's office and~     health coaches can help people take better care of themselves. But before primary care~     clinics around the country start trying to send texts, hire health coaches, or provide~     additional educational materials it is critical for them to know which approach is more~     likely to help.~      This study will assign African-American diabetics to either text messages, health coaches,~     or enhanced care to find out which one works better. The investigators especially want to~     find out if one works better for people at highest risk. Lastly, the investigators want to~     find out if messages or coaches help people improve their blood sugar, quality of life, and~     their feelings about primary care.~      The study will test messages, coaches, and enhanced care side by side in primary care~     doctors' offices. The messaging and coaching programs will give patients pretty much the~     same information, but in different ways. The text messages will be written carefully based~     on each patient's needs and interests. The coaches will be trained in how to help people get~     motivated and work to reach their health goals.~      This study will include 1000 African-American adults, ages 35-75, with uncontrolled diabetes~     and one or more additional chronic condition, living in medically underserved communities.~     People will have to have a cell phone or smart phone with texting capability and be able to~     use it to participate. 400 participants will get messages, 400 will get coaches, and 200~     will receive enhanced care.~      The investigators will be able to tell if messages and coaches work by seeing if people~     improve their diabetes self-care decisions, and if their blood sugar, quality of life, and~     feelings about primary care get better. The long-term study goal is to get primary care~     clinics all over the country to start using motivational messages or health coaches if they~     work well.~   "
7618|NCT02957500|"~     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an~     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.~   "
7619|NCT02957487|"~     The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway~     are to assess the clinical outcomes of patients with an edentate upper jaw having been~     treated with a removable full prosthesis supported by 3 implants to restore function and~     aesthetics. Clinical variables beyond implant dimensions and intraoral location, such as~     recall routines, maintenance needs, patient satisfaction and quality of life, will also be~     appraised and contrasted with an aim to elucidate their association with clinical outcomes.~     Specific evaluation will be done with regard to the following outcome criteria:~        -  crestal bone levels and periodontal conditions around implants~        -  incidence rates of biological, technical, traumatic failures / complications related to~          implants~        -  incidence rates of biological, technical, mechanical, esthetic failures/complications~          with prosthesis and prosthetic components A secondary objective is to identify the~          different risk factors for biological failures / complications, including the influence~          of medical conditions and tobacco use.~   "
7627|NCT02957383|"~     Light exposure is on the rise in recent years. In large part because of unintentional~     illumination from screens that emit light directly into the eyes. Millions of computers,~     tablets, televisions, and smart-phones are sold worldwide every month and the usage time of~     these devices is increasing constantly. Today, people are exposed to ongoing light exposure~     from these device screens, emitting short wave length (SWL) during day and night hours,~     whether as active or passive users. In sum, artificial light at night (ALAN) seem to affect~     human circadian rhythmicity (melatonin and thermoregulation) and sleep, with two major~     factors. First, wavelength of light, with SWL being most detrimental to sleep and rhythms,~     when compared to LWL (Brianard et al., 2001). Second, a dose-response relationship exists~     between increasing light intensity and poorer sleep/circadian rhythms (Brianard et al.,~     1988; West et al., 2011).~      Based on existing knowledge, we hypothesize that when compared to long wavelength LWL~     illumination, short wavelength SWL illumination from computer screen will have a more~     damaging effect on melatonin (MLT) production and secretion, interfering body temperature~     regulation and affecting sleep quality, efficiency and sleep architecture. In addition, we~     hypothesized that intensity of the screen illumination will play another important factor on~     these outcomes, we assume that high intensity compared to low intensity will have more~     damaging effect on: melatonin, thermoregulation and sleep.~   "
7628|NCT02957370|"~     This project focuses on developing specific and sensitive detectors of biomarker-based~     signatures associated with diagnosed and recurrent bladder cancer.~   "
7629|NCT02957357|"~     Through this study, the investigators seek to identify the benefits (improved survival) and~     harms (more procedures, more treatment, side effects, and quality-of-life impact) from~     different surveillance frequencies—every three vs. six vs. 12 months. Using the National~     Cancer Database and quality-of-life data from a large group of prostate cancer survivors,~     the investigators aim to compare survival, procedures/tests, treatments, and side effects in~     prostate cancer survivors who are followed with alternative surveillance frequencies and~     compare quality-of-life outcomes. The overall goal of the study is to provide high-quality~     data that will allow development of a personalized, risk-based tailored approach to~     post-treatment surveillance for prostate cancer.~   "
7630|NCT02957344|"~     Through an online survey, participants will be shown different visual presentations of~     vaccination data related to schools and child care centers. Participants will rate how~     important this information is when thinking about their child's health and school choice.~     Participants will also be asked survey questions about their knowledge of Colorado state~     vaccination legislation, their opinions and practices related to childhood vaccinations, and~     their views of a Zika virus vaccine.~   "
7631|NCT02957331|"~     The purpose of this study is test the effect of beta-adrenergic blockade on mortality in~     patients with traumatic brain injury with the hypothesis being that the addition of beta~     blockade to the treatment regime of this patient population will lower mortality and supress~     the catecholamine surge that accompanies traumatic brain injury as compared to those who do~     not receive beta blockade.~      Half the patients will be randomized to receive propranolol and half will be randomized to~     receive no beta blocker.~   "
7632|NCT02957318|"~     Results have indicated that some dietary fibers increase fecal fat excretion and~     particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these~     effects may contribute to body weight management.~      Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato~     pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control~     (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of~     secondary endpoints are investigated.~   "
7633|NCT02957305|"~     Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg~     of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been~     recommended by some international guidelines . So far, there are no recent studies comparing~     cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg). If~     cervical ripening is similar between these two regimens, costs reductions and lower side~     effects may be issued without losing quality of cervix dilatation.~   "
7634|NCT02957292|"~     The intrauterine device (IUD) is a long-term birth control method that has demonstrated high~     contraceptive efficacy and effectiveness due to its high compliance, adherence and~     persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive~     age.~      Side effects are the main reason for IUD use discontinuation. The most common reasons for~     copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and~     dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and~     amenorrhea.~      In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There~     are many studies comparing the two Levonorgestrel IUDs. However, there is any study~     comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.~      The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual~     bleeding pattern with fewer days than Copper 380 mm2 IUD users.~      This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative,~     parallel controled trial.~   "
7635|NCT02957279|"~     The amount of peripheral blood exosomes has been confirmed to change in the~     endotoxin-induced infection. The primary objectives of this study are to compare the changes~     of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the~     healthy controls.~   "
7636|NCT02957266|"~     The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of~     cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam~     radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial~     brachytherapy.~   "
7637|NCT02957253|"~     This study compare the effects of traditional follow-up by physician with a combined~     follow-up alternately by physician and nurse-led clinic. The main variables are; health~     related quality of Life, quality of care and health economics. Participants are randomized~     into control group or intervention group.~   "
7667|NCT02956850|"~     This sponsor-open, investigator- and participant-blinded, multi-center study will assess the~     safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy~     participants and in participants with chronic hepatitis B. Part I will be conducted in two~     portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include~     only healthy volunteers. Part II will commence after completion of the MAD portion of Part I~     and will include only Chronic Hepatitis B (CHB) participants.~   "
7638|NCT02957240|"~     Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their~     lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who~     undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type~     1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and~     mirror therapy), a movement representation technique, is strongly supported in the~     literature as a treatment of CRPS and has recently been suggested as a potential strategy to~     prevent its onset. Other complications include disability, wrist/forearm tightness and~     sensorimotor changes.~      The investigators propose that an early intervention protocol which includes graded motor~     imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of~     persons following closed reduction and casting of DRF relative to a standard of care~     intervention.~   "
7639|NCT02957227|"~     This study evaluates the use of an EEG device using Event Related Potentials to help~     diagnose Alzheimer's Disease in the outpatient clinical setting.~   "
7640|NCT02957214|"~     The purpose of this study is to obtain imaging biomarkers based on changes in activity~     patterns and changes in brain connectivity obtained with the analysis of functional magnetic~     resonance imaging (fMRI) and tractography that are related to chronic pelvic pain~   "
7641|NCT02957201|"~     All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen~     ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be~     identified and reviewed in cardiology clinics. These patients will be placed on waiting list~     to undergo the procedure. Patient-participants will be consented on the date of admission~     for device closure implantation.~      The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and~     10 patients undergoing LAA closure. EPC will be measured on the day of the device~     implantation, day 0 and prior to discharge on day 1.~      Patient participants are admitted overnight after the device closure implantation. Then on~     subsequent out patient cardiology research clinic follow appointments on days (3-4) and~     (7-8).~   "
7642|NCT02957188|"~     The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA)~     and 13C-arachidonic acid (AA) in young and older participants~   "
7643|NCT02957175|"~     The purpose of this study is to develop an immune-phenotype based prediction of~     postoperative SIRS in patients undergoing open heart surgery.~   "
7644|NCT02957162|"~     Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a~     number of risk factors for coronary artery disease and all to often patients admitted with~     an acute coronary syndrome have these comorbidities.~      The main stay of treatment of such patients is to perform coronary angiography and if~     required coronary angioplasty.~      Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary~     artery disease and statin therapy or loading, however these studies have excluded patients~     with significant comorbidities and therefore have not truly represented real life~     patients. This pilot study will assess EPC response in patients that are able to undergo~     coronary intervention as part of their normal clinical management under current guidelines~     regardless of pre-existing comorbidities. The research team believe this will allow~     representation of real world patients.~   "
7645|NCT02957149|"~     Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles~     heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion~     criteria will be consented to receive an intraoperative application of platelet-rich plasma,~     made from their own blood at the time of surgery, for application onto their neurovascular~     bundles in an effort to improve the healing process. Subjects will be followed for an~     additional 18 months to determine the efficacy and safety of this procedure.~   "
7646|NCT02957136|"~     This is a randomized clinical trial to assess the effect of rapid, near point-of-care~     testing for multiple common respiratory viruses and bacteria on antibiotic and~     anti-influenza medication use in emergency department (ED) patients with symptoms of~     influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a~     rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray~     Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours~     of sample collection. Randomization is at the individual patient level. Intervention~     patients will receive usual care plus the rapid multi-respiratory pathogen test. Control~     patients will receive physician-directed usual care without the rapid, multi-respiratory~     pathogen test, which may include but is not limited to no testing, point-of-care influenza~     testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory.~     The primary outcome is antibiotic administration or prescription during the initial ED~     episode of care. The investigators primary hypothesis is that rapid multi-respiratory~     pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention~     patients, relative to control patients (usual care). The investigators secondary outcome is~     administration or prescription of antivirals during the initial ED episode of care. The~     investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will~     improve anti-influenza medication use in intervention patients (composite rate of~     anti-influenza treatment in positive patients and non-use of anti-influenza treatment in~     negative patients), relative to control patients receiving usual care alone.~   "
7668|NCT02956837|"~     The purpose of this study is to rank different RSV vaccine dosages of antigen (or~     formulations) based on safety/reactogenicity and immune response data. The formulations~     eliciting strong immune responses while maintaining an acceptable safety profile will be~     considered for further evaluation, including in studies vaccinating pregnant women.~   "
7669|NCT02956824|"~     Prospective multicenter study assessing the incidence of inflammatory and structural lesions~     seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.~      The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased~     stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show~     lesions that could mimics axial spondyloarthritis. The primary objective of this study is to~     determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to~     compare the incidence and pattern of MRI inflammatory and structural lesions of the SI~     joints and to determine the factors associated with inflammatory or structural changes of~     the SI joints in a population of women. the investigators will especially compare the~     population of women within a year after childbirth versus the population of women who never~     gave birth or who gave birth over 24 months ago or more.~   "
7647|NCT02957123|"~     The investigators have designed an innovative proof-of-concept trial designed to provide~     data as to whether the treatment/rehabilitation efficacy and functional outcome of patients~     with organic brain syndrome are improved with intranasal inhalations of bioactive factors~     (BF), produced by autologous M2 macrophages (auto-M2-BFs). The rationale for this approach~     is the ability of central nervous system to repair and the important role of macrophages in~     the regulation of this process. It was found that type 2 macrophages have anti-inflammatory~     and reparative potential, whereas M1 cells possess pro-inflammatory and neurotoxic effects.~     Action of M2 macrophages is largely realized through the production a wide variety of~     bioactive factors (cytokines, chemokines, growth factors, neuropeptides, microvesicles etc)~     that inhibit inflammation, protect neurons from apoptosis, stimulate neurogenesis, the~     growth and remyelination of axons, the formation of new synapses and activate angiogenesis.~     This study uses auto-M2-BFs, as therapeutic agents and intranasal administration focusing on~     nose to brain transport, as a mode of delivery. Expected clinical effects in treated~     subjects: improvement of cognitive functions (memory, language, attention); correction of~     focal neurological deficit (paresis, spasticity, sensory disorders); reduction~     vestibular/ataxic disorders (vertigo, unsteadiness when walking); reduction of headaches;~     reduction of asthenia (weakness, fatigue); correction of emotional disorders (anxiety,~     depression).~   "
7648|NCT02957110|"~     The purpose of this study is to investigate whether daily laughter frequency is associated~     with pain intensity and emotional state ratings in individuals who have fibromyalgia~     syndrome.~   "
7649|NCT02957097|"~     The purpose of this study is to assess the effectiveness of pre-operative administration of~     gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and~     maxillofacial surgical procedures.~   "
7650|NCT02957084|"~     In this prospective, open cohort study the diagnostic value of tests based on neck anatomy~     in predicting difficult laryngoscopy was assessed.~      The anatomic features of the neck measured were head extension, mouth opening, upper lip~     bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to~     thyromental, neck circumference, thyrosternal distance, hyomental distance at full head~     extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental~     distance and ratio of hyomental distance FHE to hyomental distance NP.~   "
7651|NCT02956265|"~     Actinic keratosis are of utmost medical and economical interest because of their high~     prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their~     important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin~     sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining~     carcinoma to be resected therefore causing the problem of functional areas damaging~     (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma~     (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which~     ones will spontaneously regress (it is supposed to be the case for 20 % of such~     lesions);which ones will remain and which ones will develop into invasive carcinomas ?~      A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis~     orientation of such skin lesions could help improving diagnosis accuracy of the medical~     practitioner's visual inspection:~        -  In terms of sensitivity in order to potentially decrease the number of actinic~          keratosis evolving towards invasive carcinoma,~        -  In terms of specificity in order to potentially decrease useless resections and reduce~          resection margins and therefore reduce scars surface.~   "
7652|NCT02957058|"~     To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma~     recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR~     with thermal treatment applied to the defect margin. The primary aim of the study will be to~     ensure the safety of this approach and there will be constant monitoring to ensure that this~     is the case.~   "
7653|NCT02957045|"~     Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure~     (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often~     either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate~     whether central venous, vesical or rectal catheters could be useful to measure cough~     pressures as alternative sites to standard esophageal and gastric balloons.~   "
7654|NCT02957032|"~     Phase I, open label, non-randomized, multicenter, prospective dose escalation study of~     F16IL2 in combination with very low-dose cytarabine in subjects with acute myeloid leukemia~     relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).~   "
7655|NCT02957019|"~     Phase I/II, open-label, multicenter, prospective study.~   "
7656|NCT02957006|"~     Currently loop recorders diagnose arrhythmias and send automatic alerts to physicians based~     on R to R relationships only. We believe arrhythmia diagnostics could be improved if~     accurate detection of P and T waves as well as QRS complexes were possible.~      There is no technique available for long term outpatient monitoring of QT intervals for~     patient at risk of torsade de pointes when receiving QT prolonging drugs. We believe that if~     an accurate T wave detection algorithm were developed loop recorders could be used to~     monitor the QT interval, and perhaps even provide alerts for patients at risk.~      The objective of this study is to see if an algorithm can be developed to accurately define~     P and T waves using data from an implantable loop recorder.~   "
7657|NCT02956993|"~     The research study is designed to assess the technical feasibility and safety of a~     perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal~     popliteal, tibial or peroneal arteries immediately following successful angioplasty.~   "
7658|NCT02956980|"~     Differences in pDCs function related to gender have been demonstrated in adults but have~     never been addressed in children. Yet, differences in immune responses related to gender~     also exist in children, both in responses to pathogens and susceptibility to autoimmune~     diseases. The investigators suppose that these differences are partly linked to difference~     in pDCs functions. This study aim is to compare pDCs functions in children based on gender~     and pubertal status. This study will be performed in healthy children, boys with Klinefelter~     syndrome and girls with Turner syndrome.~   "
7659|NCT02956967|"~     Non-interventional, non-comparative, national, multi-site, single-arm prospective~     observational study to investigate home administration of Nivestim in the primary~     prophylaxis of chemotherapy-Induced febrile neutropenia~   "
7660|NCT02956954|"~     Anderson Fabry disease (AFD) is an X-linked lysosomal storage disorder caused by a~     deficiency of the enzyme alpha-galactosidase. AFD can involve various organs and lead to a~     series of clinical abnormalities. Left ventricular hypertrophy in middle-aged men is one of~     its life threatening complications. It was shown that pending the absence of myocardial~     replacement fibrosis, substitution therapy could improve myocardial morphology and function~     as well as exercise capacity. Today, there is no available marker of the efficacy of the~     treatment on the heart morphology and function.~      The T1 time (or longitudinal relaxation time) is one of the major components of the image~     formation in Magnetic Resonance Imaging (along with T2 time and proton density). Several~     techniques have been described to assess the myocardial T1-time.~      One of them called MOLLI (Modified Look Locker Inversion Recovery), was made available in~     research centres by the Siemens company. In a study published in 2013, Sado et al. showed in~     a series of various conditions (hypertension, AFD, hypertrophic cardiomyopathy, AL~     amyloidosis, aortic stenosis and healthy volunteers) that a septal T1 below a threshold of~     940ms could discriminate AFD patients. No overlap was shown with other conditions in this~     study. Our experience with T1 mapping supports that finding (even though our threshold could~     be slightly different), and we could recently detect by MRI a number of AFD patients, some~     of them with hypertrophy, some others without hypertrophy. The effect of Replagal® on the T1~     relaxation time remains unknown.~      The purpose of that study was to follow-up the heart morphology, function and myocardial T1~     relaxation time in a population of treated/untreated patients.~   "
7661|NCT02956941|"~     A cluster randomized controlled trial was chosen to exploit the robustness of this design to~     help ascertain the efficacy of the BCC intervention compared to the routine dietary~     practice. This protocol was developed according to the guidelines of the Consolidated~     Standards of Reporting Trials (CONSORT) statement extension for cluster randomized trials.~      The present study is aims to evaluate the effect of improving micronutrient intake through~     behavior change communication intervention on nutritional status and academic performance of~     school age children. Moreover, it may help to prevent or mitigate malnutrition. However to~     the best knowledge of the authors, BCC intervention using posters, and lecture for school~     teachers and students have not yet been empirically tested generally in Ethiopia,~     specifically in the study area context. The present intervention is unique in combining the~     use of conventional BCC intervention tools, that is, lecture and posters as reminder for~     intervention reinforcement.~   "
7662|NCT02956915|"~     Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the~     first-in-man TAVI performed in 2002. With increasing experience and improvements in valve~     design, the minimalist approach to transfemoral TAVI (using local anesthesia and~     fluoroscopic guidance) has become an attractive concept, and the technical feasibility of~     this approach has been well documented.~      While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the~     FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry~     (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the~     time period of 2007 to 2012. More contemporary data from other centers has been published~     showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an~     increasingly minimalist approach to TF-TAVI, the duration of monitoring required~     post-procedure remains indeterminate with a lack of formal consensus.~      Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential~     advantages, including reduction in unnecessarily lengthy hospitalization of frail and~     elderly patients in addition to cost-saving benefits. Rouen University Hospital has~     previously published a retrospective study on the feasibility and safety of early discharge,~     in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of~     our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent~     predictors of a successful early discharge.~   "
7663|NCT02956902|"~     This study tests whether people receiving clinician support to use a mobile application on~     their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than~     those who do not. Half of the participants will receive the clinician supported smartphone~     application intervention and the other half will remain on the waiting list.~   "
7664|NCT02956889|"~     This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of~     radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell~     carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).~      The recruitment period is expected to be approximately 24 months. The trial will consist of~     a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be~     treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six~     cycles (24 weeks).~      The study will end 14 months after start of treatment of the last patient enrolled and~     evaluable according to primary end point.~   "
7665|NCT02956876|"~     With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France~     according to the latest report from the Institut national du Cancer (INCa). Second leading~     cause of cancer death in men, its management is a public health problem. According to~     projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in~     digestive oncology. These projections can be concluded that the demand for care will~     continue to be growing.~      Medical advances and societal leading to increased life expectancy, have operated a mutation~     of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases.~     These changes are causing new challenges for the health system.~      To address this problem, it is asked health professionals to adapt the organization of~     health care delivery to improve efficiency, in a constrained economic environment. To this~     end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a~     proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will~     be empowered to ensure, under certain conditions, prescription treatments protocolized of~     follow-up tests, further treatment and support, as well as the extension or adaptation of~     specific treatments.~      This project is a first step, in France, in thinking around new organizations in the supply~     of care in oncology.~      For patients, strengthening their monitoring during chemotherapy, will better know their~     tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects~     will help reduce the use of emergency care.~      The establishment of such a practitioner will free medical time to handle the most complex~     patients and perform tasks related to research.~      For hospital pharmacies this type of organization will optimize their productivity by~     anticipating orders for chemotherapy pockets.~      This project represents an opportunity to demonstrate the added value of advanced practice~     nurses in France in the health system and particularly in oncology. It also adds value to~     clinical expertise nurse and register the profession in the research.~      The hypothesis is that the quality and safety of care provided by a nurse practitioner are~     equivalent to those provided by a doctor at follow-up of patients with gastrointestinal~     cancer, treated with intravenous chemotherapy.~   "
7666|NCT02956863|"~     The purpose of this study is to determine whether manipulative osteopathic treatment~     associated exercises improves pain and function in individuals with chronic non-specific~     neck pain~   "
7670|NCT02956811|"~     Left ventricular hypertrophy (LVH) is common in people with type 2 diabetes (70%) and is the~     strongest independent risk factor for cardiovascular events and all-cause mortality that~     there is. It is worse than triple vessel coronary disease. LVH often occurs in patients with~     normal blood pressures (BP). Apart from BP, the other three main factors causing LVH are~     insulin resistance, obesity and cardiac preload. Dapagliflozin reduces ALL four factors~     known to promote LVH i.e. Dapagliflozin reduces weight, glycaemia, preload and blood~     pressure and is therefore the ideal agent to reduce LVH since it uniquely attacks all four~     known mediators of LVH. This trial will investigate the ability of dapagliflozin to regress~     LVH in 64 participants with normotensive diabetes. This will be done by seeing if~     dapagliflozin reduces left ventricular mass as measured by cardiac magnetic resonance~     imaging (MRI). This trial may identify a novel way to reduce the strong independent risk~     factor of LVH which often persists despite optimum medical therapy in patients with~     diabetes. If dapagliflozin does reduce LVH, this would be a key sign of which subgroup of~     patients with diabetes (those with LVH) should be especially targeted with dapagliflozin.~      64 participants with type 2 diabetes and LVH will be recruited through the Scottish Diabetes~     Research Network (SDRN), Scottish Primary Care Research Network (SPCRN) and other routes, in~     this single centre study. Participants will be randomised to receive either 10mg~     dapagliflozin or placebo daily for 12 months. Cardiac MRI will be performed at baseline and~     at 12 months, this will be assessed for the primary outcome of change in left ventricular~     mass. Secondary outcomes will examine change in 24 hour blood pressure and weight.~   "
7671|NCT02956798|"~     The proposed study is a phase II randomized trial testing an innovative concept of comparing~     local therapy to systemic therapy, e.g. pazopanib, in patients with newly diagnosed limited~     metastatic RCC. We hypothesize that local therapy can prolong progression-free survival for~     patients with limited metastasis, and delaying the initiation of systemic therapy does not~     adversely affect survival. Patient will be stratified by Heng's criteria. Patients that are~     curable by metastatectomy as well as patients with poor prognosis and high chance of disease~     dissemination according to the prognostic factors will be excluded.~   "
7672|NCT02956785|"~     The aim of this study is to compare three different regimens for continuation of induction~     of labor after no spontaneous or artificial rupture of membranes could be achieved after~     first 24 hours post-insertion of Dinoprostone~   "
7673|NCT02956772|"~     A multicentre, randomized, open-label, parallel-group, active controlled study.~   "
7674|NCT02956759|"~     To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very~     severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment~     until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban~     patients in China.~      Interview data from some patients and survey data from ophthalmologists in the study~     hospitals will help determine acceptability of early treatment, and how to overcome barriers~     to increased use of this option.~   "
7675|NCT02956746|"~     This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi)~     and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin~     (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023,~     RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered~     with either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of~     SYN023 will be measured for the remainder of the trial while the rest of the five RVi and~     RVa doses are given. The study will last 112 days. SYN023 concentrations and anti-SYN023~     antibodies will also be measured.~   "
7676|NCT02956733|"~     The fasciotomy incisions lead to large, unsightly, chronic wounds after surgical~     intervention. The classic management was split thickness skin grafting but it leads to~     insensate skin with 23% of people upset by the appearance of the wound and 12% forced to~     changed occupation. Since no skin loss has occurred with the fasciotomy and utilizing the~     dermal properties of creep, stress relaxation and load cycling closure can be achieved in a~     better way. Our hypothesis is that using dermatotraction approximation could be done using~     inexpensive equipment readily available in any standard operating room.~   "
7677|NCT02956720|"~     Prospective, open label, self - controlled, single arm, clinical study to assess the~     performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for~     circumference reduction versus self-control.~   "
7678|NCT02956707|"~     Little is known regarding the incidence and clinical impact of AI in neonates during the~     acute postoperative period following separation from CPB. In a randomized control pilot~     study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone~     infusions improved some postoperative outcomes, especially in those that acquired AI7. In an~     attempt to further explore post-CPB AI, a retrospective analysis of data from this study was~     performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI~     following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of~     these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that~     developed AI demonstrated more hemodynamic instability, increased serum lactate and required~     more colloid resuscitation in the immediate post-CPB period in the operating room. Recent~     evidence has begun to highlight potential morbidity associated with perioperative steroid~     administration. Our cardiac surgery program is changing clinical practice and ceasing to~     give preoperative steroids to all patients (previously only neonatal CPB patients received~     preoperative methylprednisolone). With the possibility that preoperative steroid~     administration, and not CPB, primarily causes the high incidence of AI, it is prudent to~     further investigate the benefit and/or harm of perioperative steroid administration~   "
7692|NCT02956525|"~     To evaluate the interaction of food on the pharmacokinetics of Dexibuprofen 200 mg (Apsen~     Pharmaceuticals A / S.) after single dose oral administration to healthy subjects of both~     sexes, under fasting and fed conditions.~   "
7693|NCT02956512|"~     To evaluate the interaction of food on the pharmacokinetics of Dexibuprofen 300 mg (Apsen~     Pharmaceuticals A / S.), after single dose oral administration to healthy subjects of both~     sexes, under fasting and fed conditions.~   "
7936|NCT02953327|"~     The propose is to test innate immune training in a pilot study of 40 adults >50 years of age~     people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with~     increased innate immune training measured as increased cytokine release after in vitro~     Peripheral Blood Mononuclear Cells (PBMC) stimulation with e.g. Mycobacterium Tuberculosis,~     Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae.~   "
7679|NCT02956694|"~     The increasing prevalence of Alzheimer's disease and other forms of dementia causes new~     challenges to ensure that healthcare decisions are informed by research evidence and reflect~     what is important for seniors and their caregivers. Primary care providers point to a need~     for more training on communication with families of seniors living with dementia, and on the~     non-pharmacological health options that are often recommended before use of~     medications.Therefore, the investigators will design and evaluate an intervention to train~     primary healthcare providers on how to empower seniors with dementia and their caregivers in~     making health-related decisions based on research evidence and on their preferences and~     priorities. A distance professional training program on shared decision making will~     initially be designed, comprising evidence summaries to be shared with patients living with~     dementia and their caregivers who face difficult decisions. Patients with dementia, their~     caregivers and healthcare providers, will then provide feedback on the training program,~     which will then be improved following their suggestions. In a last step, the investigators~     will evaluate whether this training program truly increases the participation of patients~     and their caregivers in decision making, their comfort with the decision that they have~     made, and their motivation and ability to control their life by taking care of their own~     health.~   "
7680|NCT02956681|"~     Recruitment for prevention, and early detection among health disparities populations~     represents a major challenge in chronic disease control. This effect is magnified for~     individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis.~     Costs are typically high, particularly given the common practice of developing a single~     outreach channel to address each disease or condition. In a randomized delayed intervention~     control trial, the investigators tested a strategy to identify low-income women at high risk~     for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them~     to free genetic counseling.~   "
7681|NCT02956668|"~     Homonymous hemianopia is one of the most common symptoms following a neurologic damage and~     has many negative effects on functional abilities and daily activities.~      There are two main kind of restorative rehabilitation of hemianopia: border training,~     which involves exercising vision at the edge of the damaged visual field, and blindsight~     training, which is based on exercising the unconscious perceptual functions in the mild of~     the blind hemifield.~      In literature only border training effects were shown to be facilitated by transcranial~     direct current stimulation (tDCS).~      The investigators treat two patients with blindsight rehabilitation associated to tDCS over~     parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment~     associated to tDCS and a cycle of blindsight training alone in inverted order.~      Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance~     the improvement induced by blindsight rehabilitation treatment.~   "
7682|NCT02956655|"~     The purpose of this study is to evaluate Effect of Fasting Therapy on Blood Glucose Control~     and Islet Function in Newly Diagnosed Type 2 Diabetic Patients.~   "
7683|NCT02956642|"~     This study is a two-arm randomized controlled trial in which participants will receive~     either the Livongo Health system or iHealth glucose meter for measuring their blood glucose.~     The study hypothesizes the use of the Livongo Health system results in a greater improvement~     in A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth~     Bluetooth-enabled glucose meter.~   "
7684|NCT02956629|"~     This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug~     combination regimen (MK-3682 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for~     12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants~     with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6~     who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C)~     and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV)~     co-infection will be enrolled.~   "
7685|NCT02956616|"~     To determine whether women randomized to an enhanced recovery program will have improved~     postoperative outcomes including improved breastfeeding initiation and continuation,~     reduction in hospital length of stay without compromising patient satisfaction in comparison~     to standard postoperative recovery interventions.~   "
7686|NCT02956603|"~     The primary purpose of this study is to determine the extent to which the Regenerative~     Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual~     peripheral nerves) enables both the generation of high-performance motor control signals for~     prosthetic limbs, and the input of sensory percepts by electrical stimulation.~   "
7687|NCT02956590|"~     This trial of pitavastatin will determine efficacy and safety in this high risk population~     and provide evidence for clinicians to target this treatable risk factor to achieve an~     impact on early atherosclerosis, and potentially achieve primary prevention of adult~     cardiovascular disease.~   "
7688|NCT02956577|"~     The purpose of this study is to investigate the influence of micro- and macrovascular~     changes on the cardiac function in relation to left ventricular function and coronary~     arteries during one year in patients with type 2 diabetes.~   "
7689|NCT02956564|"~     Based on multi-center clinical research resources, a large-scale prospective cohort study~     will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal~     hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for~     China's national conditions.~   "
7690|NCT02956551|"~     The study is aimed to the test the efficacy and safety of neoantigen-primed T cell therapy~     for refractory non-small cell lung cancer.~   "
7691|NCT02956538|"~     With the development and application of biological agents, the treatment effect was~     considerable degree improvement on refractory corn's disease. However, there are quite a~     part of the CD patients lost response during treatment of using response. Moreover, due to~     various reasons, there still a lot limited on the using of biological agents in China, that~     make quite a part of the refractory CD patients lack of further medical treatment options.~     There has been a RCT study which prove that thalidomide effect and safety on treating~     refractory CD or who were lost response by using biological agents in Italy, but the object~     of study is only limited in children and adolescents. There are some small sample studies~     also confirmed the efficacy and safety on refractory corn's disease by using thalidomide,~     but need more RCT evidence.~   "
28595|NCT02682849|"~     The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active~     Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac~     surgery.~   "
7694|NCT02956499|"~     First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose~     (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The~     SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a~     total of approximately 48 healthy subjects. The MAD portion of the study will enroll four~     cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy~     subjects.~   "
7695|NCT02956486|"~     The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind,~     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's~     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early~     stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat.~   "
7696|NCT02956473|"~     This research study involves the use of a common breast imaging modality (magnetic resonance~     imaging, 'MRI') and is investigating its role in evaluating treatment for breast cancer when~     it is performed with the patient in a new position (lying on one's back) as opposed to in~     the standard position (lying on one's stomach).~   "
7697|NCT02956460|"~     Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1~     month dispensing study (2 weeks each lens pair)~   "
7698|NCT02956447|"~     The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a~     therapeutic alternative for patients with hyperprolactinemia who are intolerant to current~     therapies.~   "
7699|NCT02956434|"~     This study aims to test a brief family intervention (the BFI) to enhance~     individually-delivered PTSD treatment for Veterans.~   "
7700|NCT02956421|"~     Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based~     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the~     PIKA adjuvant. The primary objective of the study is to evaluate the efficacy and safety~     profile of the vaccine composition in healthy adult volunteers under the accelerated~     regimen. The secondary objective is to achieve higher seroconversion of the vaccine under~     accelerated regimen at Day 7.~   "
7701|NCT02956408|"~     Vitamin D deficiency is common in the general population in the United States, but is more~     common in overweight and obese children. Additionally, vitamin D levels are inversely~     correlated with body mass index, hypertension, inflammatory markers and insulin resistance.~     There are currently no clear guidelines regarding vitamin D replacement in obese but~     otherwise healthy children. The Endocrine Society recommends that children with vitamin D~     deficiency should take 2000 IU once a day for at least 6 weeks; however, they state that~     obese children may need 2-3 times this dose in order to reach sufficient levels.~      The goals of this study are:~        1. To determine the prevalence of vitamin D sufficiency (>30 ng/mL), insufficiency (21-29~          ng/mL); deficiency (10-19 ng/mL) and severe vitamin D deficiency (<10 ng/dL) in an~          obese pediatric population (2-11 years) as measured by 25-hydroxyvitamin D.~        2. To determine if vitamin D level correlates with percentage body fat by bioelectrical~          impedance analysis and/or visceral fat by waist circumference in children ages 5 - 11~          years.~        3. To observe the effect of vitamin D replacement in obese children with vitamin D~          deficiency using two different replacement dosage levels recommended by the Endocrine~          Society over three months: 2000 IU once a day (general pediatric dose) vs 6000 IU once~          a day (suggested obesity dose) in children between the ages of 5 - 11 years.~        4. To measure vitamin D levels, bone markers, inflammatory markers and vitamin D binding~          protein before and after vitamin D supplementation in children between the ages of 5 -~          11 years. Analysis will be stratified by degree of obesity (Class I, Class II, Class~          III) and season.~   "
7702|NCT02956395|"~     Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a~     key milestone to accelerate adaptation of current healthcare systems to the evolving needs~     triggered by population ageing and high prevalence of chronic conditions. Lessons learnt~     from deployment experiences are being disseminated as good practices. But, there is need~     for further assessment of implementation strategies in real world scenarios. Moreover,~     progresses achieved in disease-oriented integrated care cannot be automatically transferred~     to management of complex chronic patients (CCP). The protocol addresses five aims: 1)~     implementation of two integrated care interventions using a collaborative and adaptive case~     management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care~     for patients under long-term oxygen therapy (LTOT)); 2) adoption of information and~     communication technologies (ICT) required to support collaborative ACM; 3) to evaluate the~     impact of enhanced clinical health risk assessment and stratification; 5) to generate a~     roadmap for regional adoption of the CCP program.~      Methods/Design: the CCP program will be deployed in three healthcare sector of~     Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona~     Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following~     Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for~     evaluation purposes. The study also addresses the steps for scale-up of integrated care in~     the entire Catalan region (7.5 M citizens). Observational studies with matched controls have~     been planned for both Community-based management of CCP (n=3.000) and for Integrated care~     for patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are~     planned on top of the observational studies to test specific questions (i.e. performance of~     the ICT platform providing ACM functionalities). Main components of CCP program are: a)~     patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive~     Case management; d) Roadmap for regional adoption.~      Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP~     program, including transferability analysis, facilitating adoption of integrated care~     services for management of multi-morbidity.~   "
7703|NCT02956382|"~     This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once~     the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory~     grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.~   "
7704|NCT02956369|"~     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of~     hydrocolloids with excellent safety profiles and a long history of use in humans) and a~     lipid component (long-chain fatty acids). The goal of this combination is to achieve~     long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the~     sustained release of satiety-signals from intestinal cells, and consequently reducing~     appetite and lowering food intake in humans.~      Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and~     as first course at dinner. Once before and after these 6 weeks the investigators will carry~     out an oral glucose challenge, measure satiation hormones and examine faeces (gut~     microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal~     symptoms and quality of life. The whole study will take approximately 8-10 weeks.~   "
7757|NCT02955667|"~     This study intends to carry out a prospective, randomized controlled trial to research and~     development a new invivo microscopy based on the technology which is combined with~     high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and~     non-invasively by observing cervical tissues and cells, which makes it possible to diagnose~     cervical cancer without wounds.~   "
7705|NCT02956356|"~     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of~     hydrocolloids with excellent safety profiles and a long history of use in humans) and a~     lipid component (long-chain fatty acids). The goal of this combination is to achieve~     long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the~     sustained release of satiety-signals from intestinal cells, and consequently reducing~     appetite and lowering food intake in humans.~      Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and~     second study day, volunteers receive a preload of either SATIOSTAT or a control and then an~     oral glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured~     by means of a breath test, and insulin, glucose and satiation hormones will be assessed. On~     the third and fourth study day, volunteers receive a preload of either SATIOSTAT or a~     control and are then presented a test meal. Total calorie intake is measured as well as~     subjective feelings of satiation. In addition satiation hormones are measured.~   "
7706|NCT02956343|"~     In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices~     for its specificity and sensitivity to distinguish between AF and SR.~   "
7707|NCT02956330|"~     The purpose of this non interventional retrospective study is to continue to collect data~     from patients following their completion of Protocol CLS 1003-201: Safety and Efficacy of~     Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following~     Retinal Vein Occlusion (ie, the parent study).~   "
7708|NCT02956317|"~     This is a randomized, double-blind, within-subject placebo controlled study to evaluate the~     safety and efficacy of various doses of STP705 administered as intradermal Injection in~     subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose,~     the pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers~     common to the scar formation pathway.~   "
7709|NCT02956304|"~     The purpose of this study is determine the involvement of motor system in the memory of~     manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial~     magnetic stimulation to see whether this stimulation will affect memory of manipulable~     objects.~   "
7710|NCT02956291|"~     The purpose of the research study is to test new methods that could improve diagnosis and~     assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging~     technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning~     the patient and provides quantitative information on tumor tissue. The investigators will~     compare the data gathered from MR Fingerprinting with other imaging tests, clinical~     information, treatment details and biopsy results to evaluate the accuracy of this new~     technique.~   "
7711|NCT02956278|"~     Subjects will undergo a placebo and allopurinol phase to better understand the effects of~     the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and~     pharmacodynamics.~   "
7712|NCT02956252|"~     The aim of this study is to compare early postoperative outcomes of unselected consecutive~     patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.~   "
7713|NCT02956239|"~     This project will develop, test and produce a lightweight, cordless, battery driven and~     rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator).~     The study will evaluate its effectiveness compared to the current standard treatment~     (cryocautery) when used as part of a screen and treat programme using Visual Inspection with~     Acetic acid (VIA) in Sub Saharan Africa.~   "
7714|NCT02956226|"~     This study aims to assess the safety, tolerability and efficacy of cannabinoids mix~     [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems~     in children and youth with ASD.~   "
7715|NCT02956213|"~     The investigators will conduct a randomized, controlled, double-blind, crossover trial to~     determine whether the presence of a portable high-efficiency indoor air filter in the~     bedroom reduces respiratory symptoms in former smokers compared with placebo. The primary~     outcomes will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score~     associated with using a portable high-efficiency indoor air filter during the study period.~     Secondary outcomes of COPD exacerbations and hospitalizations, daily step counts, medication~     changes, spirometry, and cardiovascular outcomes will also be assessed.~   "
7716|NCT02956200|"~     Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor~     modulator fingolimod may be efficacious in attenuating brain inflammation and improving~     clinical outcomes in patients with AIS as a single therapy beyond 4.5 hours of disease~     onset, or in combination with alteplase within 4.5 hours of disease onset. So in this study~     the investigators try to determine whether the addition of fingolimod, administered within 6~     hours after the onset of symptoms in patients receiving alteplase bridging with mechanical~     thrombectomy, improves radiologic and clinical outcomes.~   "
7717|NCT02956187|"~     Background. Functional dyspepsia is characterized by symptoms that apparently originate in~     the stomach without detectable cause by conventional diagnosis test. The pathophysiology of~     functional dyspepsia is not known, but a number of data indicate that dyspeptic patients~     have increased sensitivity of the digestive system, so that physiological stimuli may induce~     their symptoms. Some patients with functional dyspepsia have also functional constipation~     and the investigators hypothesize that in them constipation triggers or facilitates~     dyspeptic symptoms, and consequently, correction of constipation relieves dyspeptic~     symptoms.~      Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the~     treatment of dyspeptic symptoms in patients with constipation due to functional outlet~     obstruction.~      Design. Randomized, controlled parallel trial performed in a referral center. Participants.~     Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet~     obstruction.~      Interventions: Patients will be assigned to experimental (biofeedback for functional outlet~     obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional~     outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during~     the first 3 weeks of the intervention period) combined with instructions for daily~     exercising for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks.~     Main outcome and measures. Clinical symptoms of functional dyspepsia measured by daily~     questionnaires for 7 consecutive days before and during the last week of intervention.~      Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a~     diverse group of conditions with different pathophysiology. As a result, the treatment is~     empirical and globally inefficient. This study will identify a subset of patients with a~     common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction)~     which respond to specific treatment (biofeedback).~   "
7758|NCT02955654|"~     The purpose of this study is to determine whether acceptance and commitment therapy is~     effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.~   "
7759|NCT02955641|"~     The purpose of this study is to evaluate the efficacy and need for prescribing~     anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.~   "
7760|NCT02955628|"~     This is a multicentre, open-label, phase II study of ibrutinib 560 mg in combination with~     R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell~     lymphoma.~   "
7718|NCT02956174|"~     Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided~     Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth~     in posterior regions.~      Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM~     Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were~     needed and tooth preparations were standardized and performed by 2 expert prosthodontists.~     CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were~     cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1,~     6, 12, 24, 36 and 48 months. The survival and success of the restorations were evaluated.~     The technical and esthetic outcomes were examined using the United States Public Health~     Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth~     and descriptive statistics were performed.~   "
7719|NCT02956161|"~     This monocentric, cross-over, randomised, double blind and placebo-controlled study~     evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep~     quality.~   "
7720|NCT02956148|"~     The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in~     HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs~     from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial~     PET measurement.~   "
7721|NCT02956135|"~     The aim of this study is to assess the relationship between the presence of overuse injuries~     and failure to control of movement in those areas. For this, participants will perform some~     tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more~     movement planes.~   "
7722|NCT02956122|"~     The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on~     biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in~     participants with acute GvHD with lower GI involvement.~   "
7723|NCT02956109|"~     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic~     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics~     of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel~     orodispersible tablet formulation for the treatment of children, in comparison to the adult~     tablet formulation.~   "
7724|NCT02956096|"~     Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood~     pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that~     transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in~     healthy subjects, but little is known about these effects in stroke.~      Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous~     system modulation in patients post-stroke.~   "
7725|NCT02956083|"~     The primary goal of this investigation is to determine if lipid based artificial tear~     supplementation has an impact on contact lens discomfort (CLD).~   "
7726|NCT02956070|"~     Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on~     volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be~     selected and recruited, following inclusion criteria and pre-established exclusion. All~     volunteers will be guided and sign a term of clarification and consent. Volunteers will be~     randomly divided into two groups: the control group to receive placebo capsules and~     application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro-~     (conventional treatment) and the experimental group will receive the anti-inflammatory~     corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients~     will be treated in two clinical sessions with an interval of 7 days (one week) between them.~     The protocol for use of the product is as follows: The volunteers in the experimental group~     will receive six capsules of dexamethasone 8 mg each to be administered orally, initially~     two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning~     two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day~     before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the~     first practice session of whitening. After 7 days (one week), the same protocol will be held~     for the second and final practice session office bleaching.~   "
7727|NCT02956057|"~     Study evaluates the efficacy and tolerability of low volume preparations compared with~     conventional 4L polyethylene glycol prior to colonoscopy~   "
7728|NCT02956044|"~     The purpose of this study is to examine the drug-drug interaction in your body when given~     the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin,~     glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how~     well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.~   "
7729|NCT02956031|"~     Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are~     still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current~     prevalence of pre-cancer cervical disease is largely unknown, data from local studies~     suggest regional differences and an increase in the prevalence of cytological abnormalities~     when compared with historical data. Low frequency in cytology screening is the primary~     factor attributable to development of invasive cervical cancer and almost one-third of all~     cervical cancer patients had previous negative cytology. Due to the low sensitivity of~     cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated~     by all available data. One round of optimal cervical cytology will detect around 50% of~     existing pre-cancer cervical disease as identified and proven using colposcopy and directed~     biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV)~     test can improve the sensitivity of screening and that even a single round of HPV screening~     can rapidly reduce the incidence of invasive cervical cancer and related mortality within a~     few years.~      South Africa has a high prevalence of HIV infection and a delay in or failure to initiate~     antiretroviral therapy (ART). These facts, together with the largely unscreened status of~     the female population and the high incidence of cervical cancer all suggest that HPV~     infection and precursors to cervical cancer are both unusually common among South African~     women. Accurate current knowledge of the performance of newer generation HPV based screening~     tests in HIV-infected and general female population are essential for cost-analysis and~     planning for national prevention and screening programs. This study will aim to demonstrate~     the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based~     screening assays in a South African setting.~      The investigators hypothesize that HPV testing followed by normal and special cytology tests~     will be a successful screening model for a South African population.~   "
7761|NCT02955615|"~     The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human~     recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus~     erythematosus.~   "
7762|NCT02955602|"~     An 8-week, dose ranging, open label, randomized, Phase 2 study with an 18-week extension, to~     evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis~     (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)~   "
28617|NCT02682563|"~     Background:~      Worldwide, diabetic nephropathy or Diabetic Kidney Disease (DKD), is the most common cause~     of chronic and end-stage kidney disease. With the increasing rates of obesity and type 2~     diabetes (T2DM), many more patients with DKD may be expected in the coming years. DKD is a~     multi-factorial condition, involving factors such as obesity, chronic hyperglycemia,~     advanced glycation end products, oxidative stress, pro-inflammatory cytokines, systemic- and~     glomerular hypertension. Large-sized prospective randomized clinical trials suggest that~     intensified glucose and blood pressure control, the latter especially by using agents that~     interfere with the renin-angiotensin-aldosterone system (RAAS), may halt the progression of~     DKD, both in type 1 diabetes and T2DM. However, despite the wide use of~     angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, a considerable~     amount of patients develop DKD during the course of diabetes, indicating an unmet need for~     renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are novel~     glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic~     actions 'beyond glucose control', including reduction of blood pressure and body weight. In~     addition, SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular~     pressure and albuminuria in rodents and type 1 diabetes patients. In rodents, SGLT-2~     inhibitors also improved histopathological abnormalities associated with DKD. To date, the~     potential renoprotective effects and mechanisms of these agents have not been sufficiently~     detailed in human type 2 diabetes. The current study aims to explore the clinical effects~     and mechanistics of SGLT-2 inhibitors on renal physiology and biomarkers in~     metformin-treated T2DM patients with normal kidney function.~      Hypothesis:~      Treatment with the SGLT-2 inhibitor dapagliflozin, as compared to the sulfonylurea (SU)~     derivative gliclazide, may confer renoprotection by improving renal hemodynamics, and~     decreasing blood pressure and body weight in type 2 diabetes.~      Study Design:~      A phase 4, monocenter, randomized, double-blind, comparator-controlled, parallel-group,~     mechanistic intervention trial to assess the effect of 12-week treatment with the~     sodium-glucose linked transporters (SGLT)-2 inhibitor dapagliflozin versus the SU gliclazide~     on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes~     mellitus (T2DM)~      Study Endpoints and methods:~      Renal hemodynamics, i.e. glomerular filtration rate (GFR, ml/min) and effective renal plasma~     flow (ERPF, ml/min) will be measured by the gold-standard inulin- and para-aminohippurate~     (PAH) clearance methods, respectively, during both euglycemic- and hyperglycemic clamp;~     renal tubular function will be measured by 24-hour urine sodium, potassium, chloride,~     calcium, magnesium, phosphate and urea and glucose; markers of renal damage will include~     urinary albumin excretion, neutrophil gelatinase-associated lipocalin and kidney injury~     molecule-1; blood pressure will be measured using an automated oscillometric blood pressure~     device (Dinamap®); body anthropometrics, including body weight, height, body-mass index and~     waist circumference, and body fat contents (by bio-impedance analysis) will be measured;~     blood samples will be obtained to determine glycemic variables, lipids and markers of~     inflammation; systemic hemodynamic variables (including stroke volume, cardiac output and~     total peripheral resistance) will be measured by continuous beat-to-beat hemodynamic monitor~     (NexFin®); heart rate will be determined by oscillometric blood pressure device;~     microvascular function will be measured by capillary videomicroscopy and Laser Doppler;~     arterial stiffness will be assessed by applanation tonometry, (SphygmoCor®); additional~     urine, blood and feces will be collected for conditional determination of various markers of~     renal damage/function, inflammation, oxidative stress and (cardiovascular)-biomarkers and~     DNA; cardiac autonomous nervous system (CANS) will be measured by electrocardiography and~     NexFin®; insulin sensitivity will be measured by glucose infusion during the euglycemic~     clamp (M-value); beta-cell function will be measured by quantification of insulin secretion~     during the hyperglycemic clamp.~      Expected results:~      This active-comparator controlled mechanistic intervention study, using state-of-the-art~     methodology will expand our knowledge regarding the potential renoprotective effects of~     SGLT-2 inhibitors in human T2DM. The investigators hypothesize that SGLT-2 inhibitors may~     confer renoprotection by improving renal hemodynamics, and decreasing blood pressure and~     body weight, all important factors in the development of DKD. Ultimately, the investigators~     expect that this study will contribute to guiding clinicians in their decision-making~     process of individualizing therapies for T2DM patients at risk for, or suffering from, DKD.~   "
7730|NCT02956018|"~     Kidney transplant thrombosis (loss of blood flow) is responsible for up to 35% transplant~     failures in children. Detection of kidney transplant thrombosis currently relies on~     recognition of deterioration in parameters such as urine output and blood creatinine levels,~     which change relatively slowly. Confirmation is then required with an ultrasound scan. There~     is inherent delay in the above process, during which time some or all of the transplant~     kidney tissue can die, which can result in failure of the transplant.~      Near infrared spectroscopy (NIRS) is a non-invasive technique used in continuous monitoring~     of oxygen levels in several organ systems including the brain, muscles, gut, liver and~     native kidneys. We hypothesise that NIRS can be applied to monitor kidney transplant blood~     flow in real time.~      We aim to test the use of NIRS in detecting blood flow in established kidney transplants in~     children, and to compare it with ultrasound, the current gold standard measurement. Existing~     NIRS equipment would be used within its CE marked purpose measuring oxygen levels; this~     mechanistic study would extrapolate measured oxygen levels to determine blood flow.~     Participating children attending outpatient clinic for routine transplant ultrasound scans~     will have NIRs monitoring for a 10 minute period. NIRs data will be compared to a validated~     perfusion score from ultrasound images.~      If this study is successful, NIRS could provide continuous monitoring of kidney transplant~     blood flow in the postoperative period, thus allowing immediate detection of blood flow~     problems. This has potential to reduce kidney transplant failures from thrombosis.~   "
7731|NCT02956005|"~     The purpose of this study is to collect data prospectively on African American patients who~     are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if~     African American renal transplant recipients that receive Envarsus will have less tubular~     injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.~      African americans have the higher rates of CYP3A5 which is associated with the need of~     higher tacrolimus dose to achieve an adequate level and this many times is associated with~     signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.~      The retrospective cohort will be African American patients that will be matched by age,~     gender, type of kidney transplant (living vs deceased) and level of sensitization~   "
7732|NCT02955992|"~     As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a~     mortality rate of 20%, end-of-life care has become a daily responsibility. Among those~     deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where~     physicians, nurses and relatives must work together towards the most consensual decision. In~     this context, patients' relatives feel vulnerable and, in the months that follow the death,~     they are most likely to present symptoms that negatively affect their quality of life~     (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication~     with caregivers is one of the most highly valued aspects of care that impacts on family~     members' experience during the patient's stay and after the patient's death. Improving~     communication during the end-of-life process in the ICU context is a necessity that has been~     put forward in palliative care and family-centered care guidelines.~      This study aims to improve both communication skills and behaviour by giving precise~     recommendations to physicians (3 step strategy) in their direct contact with patients'~     relatives. We designed a 3-step physician-driven support strategy that consists in 3~     meetings with the relative - one before, one during and one after the patient's death. We~     hypothesize that this strategy will improve communication in the end-of-life setting and~     thus should reduce post-ICU burden for family members, specifically the development of~     prolonged grief 6 months after the death.~   "
7733|NCT02955979|"~     Iodinated contrast media are now frequently used in diagnostic imaging exams, including~     pediatrics.~      In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in~     3-33% of exposed patients, especially as the patient is fragile, has comorbidities or~     pre-existing renal aggression .~      In children, the prevalence of this little known disease is probably underestimated.~      The investigators intend to conduct a prospective epidemiological study, to estimate the~     impact of the acute renale failure to iodinated contrast agents in pediatrics.~   "
7734|NCT02955966|"~     OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the~     normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary~     aspergillosis (IPA) could occur earlier than that of conventional imaging.~      This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6.~     The latter response will be correlated with the kinetics of selected biomarkers including~     antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host~     response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.~   "
7735|NCT02955953|"~     The study will aim to evaluate the following:~        -  Whether there are any differences in the way the body handles LY2963016 U-200 and~          LY2963016 U-100.~        -  How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.~        -  How LY2963016 U-200 affects the level of blood sugar in the body compared with~          LY2963016 U-100.~      The study will last up to 17 weeks for each participant, including initial screening and~     follow up.~   "
7736|NCT02955940|"~     The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib~     plus background cancer therapy, or background cancer therapy alone to subjects from an~     Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been~     terminated.~      This study will also provide another mechanism for reporting adverse events related to study~     drug safety.~   "
7737|NCT02955927|"~     This study aims to compare effects in retardation of myopia progression of combined ortho-k~     and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus~     on optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology~     (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect.~     Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic~     progression.The use of 1% atropine was limited by the manifestation of side effects and~     rebound effect.However, both side effect and rebound effect was minimal with 0.01%~     atropine.It was suggested that 0.01% was the optimum concentration for controlling~     myopia.The mechanisms of neither ortho-k nor atropine in myopia control are fully~     understood.It is believed that ortho-k and atropine act via different mechanisms.It is~     possible that by combining these two methods, additional retardation of myopia progression~     could be achieved.~   "
46379|NCT02449941|"~     The purpose of this study is to know the distribution of HP in stomach before use of PPI,~     during use of PPI, and after stop of PPI.~   "
7738|NCT02955914|"~     Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous~     research on this topic has focused on patient reported quality of life but has never~     examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes~     to establish whether patient outlook (optimistic or pessimistic) before a heart operation~     can influence recovery and length of hospital stay. If there is a difference, then a case~     can be made for providing psychological support before an operation in the hope of modifying~     outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients~     will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be~     ascertained using two standardised questionnaires. Their recovery and length of stay will be~     recorded. The study will answer the research question and determine whether outlook has an~     impact on recovery. Depending on the results, this study could provide opportunities for~     additional future research into modifying outlook with a view to improving patient care and~     recovery.~   "
7739|NCT02955901|"~     Colonoscopy is one of the most common methods for the diagnosis and treatment of lower~     gastrointestinal tract diseases and provides a unique opportunity to identify early~     neoplastic lesions.~      Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing~     regimens, study of patient-related risk factors to fail a proper preparation and diet~     adaptations have been studied recently.~      A low residue diet is the standard in the day before the colonoscopy. Some endoscopists~     prescribe this dietary plan for a 3-day period prior to the exam, although no study compared~     the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation~     results.~      The aim of this project is to determine if the use of a 3-day low residue diet improves~     bowel preparations results and the influence in patient tolerability and adherence.~   "
7740|NCT02955888|"~     This is a Phase 2, multi-center, double blind, placebo controlled study to evaluate the~     safety and tolerability of PBI-4050, and its effects on the pancreatic, pulmonary functions~     and on various biomarkers in Cystic Fibrosis patients with abnormal glucose tolerance.~     Patients with abnormal glucose tolerance have elevated glucose level either at 1 hour or 2~     hour during an Oral Glucose Tolerance Test (OGTT). The Main study will include 24 weeks of~     treatment with PBI-4050 or matching placebo. At the end of the treatment period, patients~     will have the option of participating in a 24-week Extension study.~   "
7741|NCT02955875|"~     The purpose of this study is to examine the effectiveness of pharmaceutical care service in~     the management of poorly controlled type 2 diabetes mellitus.~   "
7742|NCT02955862|"~     CRICS financial report for the first budget year of the study~   "
7743|NCT02955849|"~     Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser~     trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with~     medically uncontrolled open angle glaucoma in rural China, taking into account the impact of~     patient acceptance of each type of treatment~      Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty~     will be lower than with surgery due to higher acceptance rates among patients randomized to~     receive this treatment and therefore treatment provided at an earlier stage of disease~     progression.~   "
7744|NCT02955836|"~     Objective: The purposes of this study are 1) to understand the nurses' need and perception~     toward of the monitoring information system of nursing-related patient safety and quality~     indicators; 2) to establish the monitoring information system of nursing-related patient~     safety and quality indicators; 3) to evaluate the monitoring information system of~     nursing-related patient safety and quality indicators.~      Methods: There will be three phases and the study site in the medical center in northern~     Taiwan. The first phase is information needs assessment. Researchers will hold the meeting~     of focus group discussion. The subjects will be the nursing manager, head nurse, clinical~     nurses who are similar to nursing-related patient safety and quality indicators. The~     self-conducted semi-structure discussion form will be used to collect the data during the~     meeting of focus group discussion. The questionnaire will be used to collect the perception,~     attitude, behavior, satisfaction, time-consuming and the accuracy of nursing-related patient~     safety and quality indicators data from nurses. The second phase will establish the~     monitoring information system of nursing-related patient safety and quality indicators and~     clinical implementation. The third phase will evaluate the effectiveness of the monitoring~     information system of nursing-related patient safety and quality indicators. The~     questionnaire will be used to collect the satisfaction, time-consuming and the accuracy of~     nursing-related patient safety and quality indicators from nurses during the evaluation~     phase.~   "
7745|NCT02955823|"~     A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line~     therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large~     B-cells non-Hodgkin Lymphoma.~   "
7746|NCT02955810|"~     This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with~     newly diagnosed Multiple Myeloma (MM) will be treated with~     Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA).~      The safety profile of daratumumab to date, which does not appear to overlap with those known~     for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of~     daratumumab combined with various backbone regimens may improve the treatment effect of~     these regimens. Additionally, daratumumab as a single agent may prolong the progression free~     interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP,~     there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing~     regimen. This will be the first clinical trial to explore the feasibility of combining~     daratumumab with a cyclophosphamide containing backbone induction regimen and if successful~     will provide the rationale for larger studies exploring the efficacy of this combination in~     greater detail.~   "
7763|NCT02955589|"~     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy~     of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)~   "
7764|NCT02955576|"~     The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic~     plaques.~   "
7765|NCT02955563|"~     We seek to develop a pragmatic, scalable intervention to overcome problems with surrogate~     decision making in ICUs.~      Our aim is to conduct a pilot study among 100 surrogates and clinicians of incapacitated~     patients at high risk of death to assess the impact of the CSDM (communication and shared~     decision making) web-based tool on key elements of decision making quality.~   "
7747|NCT02955797|"~     The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine~     when used as a single-dose toddler vaccine in individuals who are either meningococcal~     vaccine naïve or have received one or more doses of monovalent meningococcal C (MenC)~     vaccines during infancy.~      Primary Objectives:~        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups~          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in~          toddlers who either are meningococcal vaccine naïve or have received monovalent MenC~          vaccination during infancy~        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups~          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in~          meningococcal vaccine naïve toddlers~      Secondary Objectives:~        -  To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal~          serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as~          measured by hSBA in toddlers who either are meningococcal vaccine naïve or have~          received monovalent MenC vaccination during infancy~        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W~          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in~          meningococcal vaccine naïve toddlers~        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W~          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers~          who received monovalent MenC vaccination during infancy.~      Observational Objective:~        -  To evaluate the safety profile of MenACYW conjugate vaccine and Nimenrix®.~   "
7748|NCT02955784|"~     The investigators are proposing a prospective one-arm cohort study testing the feasibility~     of a game designed to improve symptoms in adults with mild levels of stress, depression, and~     anxiety. The study will take place at Madigan Army Medical Center. Primary outcomes include~     usage data including time, frequency and duration of app use, participant satisfaction with~     the game, and comments and suggestions regarding participants' experiences using the~     Sinasprite game over a 12-week period. Participants will download Litesprite's game,~     Sinasprite, onto their personal smartphone. Elements of cognitive-behavioral therapies like~     cognitive strategies, diaphragmatic breathing, and visualization are embedded in the game~     enabling participants to learn to achieve the desired healthy habits. The game's goal is to~     help Socks the Fox become a Zen Master. Over six weeks, players help Socks to progress by~     describing and categorizing their concerns, entrusting Socks to hold these concerns, and~     engaging in bonding activities with Socks, such as fishing and meditation. The investigators~     currently have a prototype and have been told by insurance firms, providers, and self-funded~     employers that they need to see validated results from a pilot study that shows feasibility~     with subjects in the target audience before they can consider a commercial roll out.~     Participants will complete questions related to mood, stress, and well-being at baseline, 6~     weeks, and 12 weeks. Data will be evaluated in real-time and reports of participant progress~     will be provided to the participant's provider, with the participant's consent. Data and~     feedback from this pilot study will be used to update the design and inform the technical~     development team to further refine the game experience in preparation for a larger~     randomized controlled trial evaluating the effectiveness of Sinasprite.~   "
7749|NCT02955771|"~     This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The~     study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition~     to stenting compared to stenting alone in patients with unresectable advanced Perihilar~     Cholangiocarcinoma.~   "
7750|NCT02955758|"~     This phase II trial studies how well pembrolizumab works in treating patients with~     non-squamous non-small cell lung cancer which has spread to other places in the body.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread.~   "
7751|NCT02955745|"~     Current iodine requirements defined for pregnancy and lactation are rough factorial~     estimates extrapolated from older studies in adults that used radioactive iodine tracers. To~     ensure optimal thyroid function in these vulnerable groups, a tracer method that could be~     safely used to accurately define iodine requirements would be valuable. Iodine-129 (129I), a~     long-lived semi-stable isotope with no health risks, could be used as a tracer, but the~     analytic challenges are formidable. However, we have developed an ICP-MS method to measure~     pp-billion (10-9) to pp-trillion (10-12) quantities of 129I in biological samples. In this~     project we will perform a study in which iodine-replete adult subjects will consume an oral~     dose of 129I. We will quantify 129I kinetic patterns in plasma, urine and stools after the~     oral dose, and use these data to derive tracer absorption, retention and excretion rates.~     This trial will allow us to define optimized procedures for the routine application of this~     method to assess iodine metabolism in humans. The use of 129I may prove to be a breakthrough~     technique to safely assess iodine metabolism and requirements in pregnant/lactating women in~     order to ensure healthy thyroid function in these age groups.~   "
7752|NCT02955732|"~     We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after~     intranasal dosing employing pharmacometric methods in otherwise healthy 1 month to 11 years~     of age children scheduled for minor surgery or other procedures requiring sedation or~     anesthesia.~   "
7753|NCT02955719|"~     Age remains the single most significant risk factor for developing dementia, particularly~     Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest~     to determine modifiable risk factors, whether by prevention, earlier detection, or an~     ability to slow the rate of decline, is a key priority in health care. Primary care is~     likely to play a pivotal role in this initiative. Collaborative mental health care between~     primary care providers and mental health clinicians has been demonstrated to be effective at~     the patient and system levels. Thus, the overall goal of this project is to assess impact~     and feasibility of implementing a collaborative care evidence-based Integrated Care Pathway~     (ICP) in addressing three potentially reversible risk factors at high risk for developing~     AD: anxiety, depression, or mild cognitive impairment (MCI).~   "
7754|NCT02955706|"~     clinical trial to assess the efficacy of Acetyl-L-carnitine~   "
7755|NCT02955693|"~     The purpose of this study is to determine how the organism affects MMF (metabolite of~     dimethyl fumarate [DMF]) after single oral dose administration of LAS41008 120 mg~     gastroresistant tablet and Fumaderm® 120 mg gastro-resistant tablet under fasting and fed~     conditions. The study also aims to assess the safety of the study treatments.~   "
7756|NCT02955680|"~     Mother spend a large amount of time with their children. It is assumed that mother~     contributes to their neurological development not only with visual stimuli, but also with~     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in~     response to the self-name being spoken by the mother than by a stranger. Therefore,~     investigators suppose that recorded maternal voice can stimulate the pediatric patients and~     thereby fasten the emergence from general anesthesia.~   "
7766|NCT02955550|"~     This study will find the highest acceptable treatment dose and timing of infusion of cord~     blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with~     multiple myeloma.~      The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is~     administered after treatment to help the NK cells expand in the body. The safety of this~     treatment will be studied and researchers want to learn if NK cells will help in treating~     multiple myeloma.~   "
7767|NCT02955537|"~     This study seeks to evaluate a multicomponent mobile intervention to change multiple~     hypertension-related health behaviors in African Americans with uncontrolled hypertension.~     Half of the participants will receive a mobile intervention designed to improve physical~     activity, sodium intake, and medication adherence. The other half will receive usual care.~   "
7768|NCT02955524|"~     The objective of this study is to use local topical anesthesia to numb the sensory input,~     captured by branches of the Trigeminal nerve found on the skin in and around the eye, to~     decrease a hemodynamic reflex seen during placement of a catheter for intra-arterial~     chemotherapy (IAC) for eye tumors in children. This Trigeminal-cardiac reflex brings about~     hemodynamic instability during general anesthesia.~      Normally, one could block this sensorial input with ophthalmic peribulbar placement of local~     anesthetics, but these eyes have malignant growth and invasive procedures may cause more~     harm. The investigators are aiming to numb the sensory branches of the trigeminal nerve~     non-invasively and observe for any decrease in these events.~   "
7769|NCT02955511|"~     Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the~     time required to achieve successful tracheal intubation and improve the glottic view.~      Study objective The purpose of this research study is to compare 3 different laryngoscope~     blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required~     to achieve successful tracheal intubation and improve the physician's view of the glottis~     compared to the standard direct laryngoscope using the blade size 3, in patients undergoing~     lumbar surgery.~      Primary end point: time to achieve successful tracheal intubation.~      Secondary end points: glottic view at intubation, number of intubation attempts and~     effectiveness of the integrated suction in the Inscope Direct Laryngoscope.~   "
7770|NCT02955498|"~     The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and~     S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination~     formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a~     combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
7771|NCT02955485|"~     Chronic ankle instability is a common problem that may follow an ankle sprain. Until a~     patient has developed chronic ankle instability they are ineligible for surgical treatment~     although early surgical treatment yields better results compared to surgical treatment of~     subjects that have experienced recurrent ankle sprains. However, treating all patients with~     an ankle sprain surgically is not an option due to the high amount of unnecessary invasive~     interventions.~      The objective of this study is to identify which patients will develop chronic ankle~     instability and to develop a model to predict which patients should receive early surgical~     treatment.~      In this prospective observational cohort all patients (older than 18 years) that report at~     the emergency department of the participating hospitals after a lateral ankle sprain, of~     whom an x-ray is made after positive Ottawa Ankle Rules and on which there is no visible~     fracture or other pathology.~      The main study parameter is a significant difference in patient characteristics, foot and~     ankle configuration and joint pathology between patients who develop chronic ankle~     instability and patients who do not experience recurrent ankle sprains and restriction~     during daily live after an initial sprain.~   "
7772|NCT02955472|"~     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR~     GLARS-NF3 tablet 150mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 150mg~     administered regular diet and (2) determine the safety and tolerability of a single dose of~     GLA5PR GLARS-NF3 tablet 150mg administered regular diet and GLA5PR GLARS-NF1 tablet 150mg~     administered regular diet.~   "
7773|NCT02955459|"~     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and~     pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion~     in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2~     subjects will receive VNRX-5133 for 7 days.~   "
7774|NCT02955446|"~     This is a single-center, open label, non randomized, compassionate use protocol in patients~     with advanced solid tumor malignancies who were previously enrolled in the phase I study~     (NCT00878189) of this agent.~   "
7775|NCT02955433|"~     This study is a prospective clinical trial designed to primarily test the impact of~     rideshare-based transportation services from a digital transportation network, Lyft, on~     reducing primary care clinic missed appointments--a composite outcome of no-shows and same~     day cancellations--for Medicaid patients. The study population consists of West Philadelphia~     residents who are established patients at two of the Penn Medicine Primary Care Practices~     within the University of Pennsylvania Health System. The study subjects are allocated into~     the intervention or control arm using a pseudorandomization approach - those receiving an~     appointment reminder on an even calendar day are in the intervention arm and odd calendar~     day calls are in the control arm.~      Secondary outcomes include the time of arrival to the clinics relative to actual appointment~     time (both arms), prospective utilization of acute care settings (both arms), prospective~     utilization of primary care (both arms), and description of programmatic metrics in the~     intervention arm (travel time, misuse, and costs). The investigators will assess the patient~     experience after each ride using a telephone-based survey and in-depth interviews. All~     adults with established primary care at the Penn Medicine Clinics, who have Medicaid, and do~     not require wheelchair accessible rides will be eligible for the rideshare service. The~     investigators hypothesize that individuals offered a rideshare-based transportation service~     will have a decreased proportion of missed appointments and same day cancellations as those~     not offered the service.~   "
7814|NCT02954926|"~     Majority of healthcare authorities believe that due to the methodological weakness and small~     number of patients in conducted therapeutic trials, the evidences are insufficient to~     support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal~     sepsis. The objective of this research is to determine the effect of intravenous~     immunoglobulin in prevention of preterm neonatal sepsis.~   "
7776|NCT02955420|"~     Berlin Cures develops BC 007 to treat patients suffering from diseases (chronic heart~     failure, pulmonary hypertension, chronic fatigue syndrome etc.) which are associated with~     functional autoantibodies (AAB) directed against G-protein coupled receptors (GPCR).~      The first part of the study (part A) is designed to evaluate the safety and tolerability of~     ascending doses of BC 007. The study part is blinded and placebo controlled in order to~     better discriminate possible safety signals. The assessment of safety and tolerability in an~     elderly cohort is a bridge to dosing elderly GPCR AAB positive subjects in part B. The~     subjects in part A are confirmed to be GPCR AAB negative.~      The objective of the second part of the study (part B) is to evaluate the efficacy of BC 007~     in neutralizing AAB against GPCR shortly after dosing compared to baseline and to find the~     optimal dose for the neutralization of the AAB in all individuals. This dose shall be taken~     to progress into a Phase II/III trial with beta1-adrenergic receptor-AAB positive patients~     suffering from chronic heart failure.~   "
7777|NCT02955407|"~     Patients with inflammatory back pain were shown to differ from healthy controls in genotype~     of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation.~     The aim of this study is to investigate whether genetic reduction of muscle perfusion might~     be a pathophysiological pathway of how genes influence chronic non-specific low back pain~     (LBP).~   "
7778|NCT02955394|"~     This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant~     plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced~     AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.~   "
7779|NCT02955381|"~     Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55~     years old of all skin types will be asked to sign an informed consent form prior to any~     study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm~     located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or~     Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study).~     Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to~     Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and~     Month 6 (study exit visit). The treatment area will be evaluated at each visit by the~     unblinded investigator regarding erythema, bruising, inflammation, itching,~     stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events~     will be captured at each visit only by the unblinded investigator.~   "
7780|NCT02955368|"~     The purpose of this study is to determine superiority of DP-R212 comparing to each~     monotherapy in patient with hypertension and primary hypercholesterolemia.~   "
7781|NCT02955355|"~     The purpose of this study is to assess the long-term safety, tolerability, and~     immunogenicity of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous (IGSC)~     facilitated with recombinant human hyaluronidase (rHuPH20) (HYQVIA/HyQvia) in participants~     with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) who have completed~     Baxalta Clinical Study Protocol 161403 Epoch 1 or Clinical Study Protocol 161601 without~     CIDP worsening.~   "
7782|NCT02955342|"~     To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back~     and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.~   "
7783|NCT02955329|"~     This study will investigate the delivery, systemic exposure, subjective and physiologic~     effects of THC vaped from e-cigarettes.~   "
7784|NCT02955316|"~     The primary objective of this study is to estimate the overall prevalence of IBS medically~     diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.~   "
7785|NCT02955303|"~     This study assess the feasibility of novel cognitive intervention utilizing tablet apps~     (TECH protocol: Tablet Enhancement of Cognition and Health) in terms of relevance,~     adherence, suitable challenges, training time etc. for healthy older adults. Sixty two older~     adults with normal cognition will be randomly allocated to the TECH protocol (experimental~     group) or the control group (no treatment). Assessments will be administered pre and post~     the 6-week TECH protocol by assessors blind to group allocation.~   "
7786|NCT02955290|"~     This phase I/II trial studies the best dose and side effects of CIMAvax vaccine and~     nivolumab and to see how well they work in treating patients with stage III-IV non-small~     cell lung cancer. Vaccine therapy, such as CIMAvax vaccine may help slow down and stop tumor~     growth. Monoclonal antibodies, such as nivolumab, may block a protein needed by tumor cells~     to grow and spread. Giving CIMAvax vaccine together with nivolumab may work better in~     treating patients with stage IIIB-IV non-small cell lung cancer.~   "
7787|NCT02955277|"~     This study assess the effectiveness of novel cognitive intervention utilizing tablet apps~     (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities,~     daily function and health-related quality of life of older adults with MCI. Forty six older~     adults with MCI will be randomly allocated to the TECH protocol (experimental group) or~     standard care (control group). Assessments will be administered pre and post the 6-week TECH~     protocol and at 6-month follow-up by assessors blind to group allocation.~   "
7788|NCT02955264|"~     The goal of this study is to better characterize the metabolic alterations and sugar~     structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital~     Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of~     oral galactose treatment in a small pilot group of Congenital Disorders of Glycosylation~     patients. The investigators will also determine the relationship between simple milk sugar~     intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation~     abnormalities.~   "
7789|NCT02955251|"~     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2~     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)~     profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in~     participants with advanced solid tumors.~   "
7859|NCT02954341|"~     The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF~     System in patients with Class III Heart Failure in a commercial setting.~   "
7937|NCT02953314|"~     This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the~     PK, safety, and tolerability of multiple doses of VX-661 in combination with ivacaftor in~     subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the~     F508del-CFTR mutation.~   "
7790|NCT02955238|"~     The Latino population in the United States is increasing in size; is diverse in culture,~     backgrounds and countries of origin; is experiencing unique influences from social and~     behavioral acculturation to the U.S.; is reported nationally to have lower rates of heart~     disease; is reported to have increased prevalence of diabetes and asthma; and is generally~     poorer and less educated (NHLBI working Group, 2003). They represent an important target~     population for disparities research. In particular Latinos accessing care in Community~     Health Centers in the United States represent an ideal population for conducting disparities~     research because lack of access to care is minimized through various governmental health~     insurance support mechanisms. This study will build on existing relationships to conduct the~     proposed study, using expertise in epidemiologic, behavioral and genetic research in an~     effort to promote a coordinated, comprehensive, interdisciplinary and focused research~     effort to improve the care being delivered to indigent Latinos at-risk for and with CVD.~   "
7791|NCT02955225|"~     The purpose of this study is to determine whether use of a pressure-detecting shoe improve~     can enhance favorable loading conditions at the knee.~   "
7792|NCT02955212|"~     This is a Phase 3 multicenter study that includes two periods. Period 1 is a 12-week,~     randomized, double-blind, parallel-group, placebo-controlled period designed to compare the~     safety and efficacy of ABT-494 versus placebo for the treatment of signs and symptoms of~     participants with moderately to severely active RA who are on a stable dose of csDMARDs and~     have an inadequate response to csDMARDs. Period 2 is a blinded 52 week extension period to~     evaluate the long-term safety, tolerability, and efficacy of ABT-494 in participants with RA~     who have completed Period 1.~   "
7793|NCT02955199|"~     This is a Stage III community-based randomized clinical efficacy trial testing Mothering~     from the Inside Out (MIO), the first evidence-based parenting intervention designed to be~     delivered by addiction counselors in addiction treatment settings where parents of young~     children are enrolled in treatment.~   "
7794|NCT02955186|"~     The purpose of this study is to evaluate the effects of the study medication,~     saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory~     setting in which participants are given an initial drink of alcohol followed by the choice~     to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that~     saracatinib will reduce craving and number of drinks consumed prior to and after exposure to~     the initial drink of alcohol and during the three hour drinking period.~   "
7795|NCT02955173|"~     The primary purpose of this study is to compare both short-term and long-term treatment~     effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on~     circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out~     principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary~     purpose is to establish an evaluation system for laparoscopic surgery for progressive~     gastric and rectal cancer treatment using CTC as a biomarker.~   "
7796|NCT02955160|"~     This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a~     2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of~     pneumococcal vaccination will be randomized equally to receive either a single intramuscular~     dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria,~     acellular pertussis combination vaccine (Tdap) (control group).~   "
7797|NCT02955147|"~     The purpose of this study is to determine whether ustekinumab is effective in the treatment~     of Giant Cell Arteritis (GCA)~   "
7798|NCT02955134|"~     The purpose of this study is to evaluate long-term efficacy of Chinese medicine treatment~     for chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.~   "
7799|NCT02955121|"~     Randomized controlled study to examine physician use of pharmacogenetic information in~     patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).~   "
7800|NCT02955108|"~     The objective of this study is to look at the effects of distractive auditory stimuli (DAS)~     on reducing dyspnea intensity and related anxiety and increasing exercise tolerance.~     Investigators hope that compared to a no-music control condition, that under a music~     condition participants with COPD will (a) demonstrate increased self-paced walk distance and~     enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have~     less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a~     tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive~     and performance enhancing effects in order to increase tolerance to dyspnea and exercise.~     The long-term goal of this study is to increase physical activity in adults with COPD and~     RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli~     in the form of music.~   "
7801|NCT02955095|"~     The purpose of the usability and pilot testing for the project Developing a Bi-national~     Buddy Intervention for Smoking Cessation and Cultural Education is to better understand how~     users interact with the smoking cessation app, and to improve the product based on the~     results. In pilot testing the smoking cessation app the investigators will examine the~     feasibility of our approach. The usability testing portion of the study is intended~     primarily to improve on the design of the smoking cessation app, and will: gather~     quantitative data on participant's performance, identify usability problems, and determine~     user satisfaction with the app. The pilot testing portion of the study will evaluate the~     feasibility, time, cost and statistical variability in an attempt to predict an appropriate~     sample size and improve upon the study design prior to performance of a full-scale research~     study.~      Objective 1:To collect quantitative data on participant's performance while using the app~     for smoking cessation.~      Objective 2:To identify problems with usability of the smoking cessation buddy app.~      Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To~     improve upon the design of the smoking cessation buddy app Objective 5:To assess the~     feasibility, time, cost, and statistical variability for a full-scale implementation of this~     study with the intervention group.~   "
7870|NCT02954198|"~     With the availability of well-studied once-daily formulations of tacrolimus, the ability to~     achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may~     finally be achievable and have the potential to optimize immunosuppression safety and~     efficacy in kidney transplantation.~   "
12416|NCT02894684|"~     This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of~     CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV~     anti-pseudomonals.~   "
7802|NCT02955082|"~     Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world, with over~     40,000 new cases diagnosed each year in the United Kingdom (UK). Research studies have~     identified several genetic changes that are thought to increase the risk of developing~     prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair~     genes. The BARCODE 2 study is formed of two parts that aim to investigate how having genetic~     changes in DNA repair genes can affect response to treatment. In part 1 of the study, the~     investigators will invite men with metastatic castration resistant prostate cancer (mCRPC)~     who have not had genetic testing before to join the study by initially undergoing genetic~     screening within the study. If a pathogenic mutation is confirmed in one of these genes,~     patients will be given the option to proceed to part 2 of the study. In part 2 of the study,~     men with mCRPC who are known to be carriers of a mutation in DNA repair gene(s) will be~     assessed for eligibility for treatment on the study. The aim of the study will be to~     determine how patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to~     platinum chemotherapy. This study will help researchers to investigate the platinum~     sensitivity of prostate tumours that have developed due to a germline mutation in a DNA~     repair gene. This study will provide data to use in a larger clinical trial of platinum~     chemotherapy based on patients' germline genetic signature and/or tumour genetic profile.~   "
7803|NCT02955069|"~     This is a study to investigate the efficacy and safety of PDR001 in patients with advanced~     or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or~     thoracic origin~   "
7804|NCT02955056|"~     This is a single site feasibility trial to test whether daily administration of~     Teriparatide, in participants with Weber type B ankle fractures that are being~     conservatively managed, is superior to the standard care treatment with regard to the rate~     of healing.~   "
7805|NCT02955043|"~     The goal of this project is to conduct a pilot randomized clinical trial (RCT) to evaluate~     the feasibility of a brief, behavioral intervention to improve recovery following~     hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT~     will learn behavioral techniques to improve sleep and increase daytime activity with the~     goal of alleviating insomnia, fatigue, and depression. If the intervention demonstrates~     evidence of feasibility and acceptability, a future study will test the effects in a larger~     trial, with the long-term goal of improving the care and quality of life of cancer survivors~     recovering from HSCT.~   "
7806|NCT02955030|"~     The purpose of this study is to evaluate the safety and immunogenicity of a sublingual~     administration of NSV0001 in healthy male volunteers.~   "
7807|NCT02955017|"~     The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass~     index decrease at 15 months compared to traditional management in obese adolescents.~   "
7808|NCT02955004|"~     The purpose of this study is to study the effects of transthoracic electrical cardioversion~     for restoration of sinus rhythm in patients who present with recent onset atrial~     fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive~     function, as well as electrical and functional/structural reverse remodelling, and its~     effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides,~     coagulation activity, and active fibrinolysis.~   "
7809|NCT02954991|"~     The study will evaluate the clinical activity of nivolumab in combination with 3 separate~     investigational agents, glesatinib, sitravatinib, or mocetinostat.~   "
7810|NCT02954978|"~     Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor~     and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the~     substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs)~     that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis,~     Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated~     for CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and~     promotes autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA~     neurons and improvement of motor function in PD models. For these studies, Nilotinib~     (1-10mg/kg daily) was used at significantly less than the clinically approved dose (up to~     1200mg daily) in CML.~   "
7811|NCT02954965|"~     The purpose of the current study is to test the efficacy of two brief, behavioral~     interventions intended to improve burnout among doctoral-level graduate students (n = 102).~     Specifically, individuals will be randomly assigned to one of three intervention conditions:~     1) Reward: a brief intervention to help participants increase engagement in healthy and~     rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants~     identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control~     condition that involves monitoring only. Multilevel modeling will be used to assess changes~     in burnout, mood, and stress, following the interventions, controlling for participants'~     individual baseline levels of these variables.~   "
7812|NCT02954952|"~     The SedLine EEG monitor (Masimo Corporation, Irvine, CA) computes the following parameters:~     the Patient State Index (PSI) that is calculated via 4 channels of high resolution EEG data,~     EMG activity, and percent of EEG suppression.~      Unlike most other non-invasive patient monitoring parameters, there is no gold standard or~     reference against which the SedLine/Patient State Index (PSI) could be compared. Hence, to~     evaluate performance of two algorithms, historically clinical outcome parameters such as~     post-surgery wake-up time, amount of anesthesia used, and frequency of somatic events were~     compared to evaluate algorithm performance.~      The new (investigational) PSI is similar to the current (FDA-approved) PSI but has new~     features to compute PSI. The data collection study and methodology as described in this plan~     forms the basis for evaluating performance of the new (investigational) PSI against the~     current (FDA approved) PSI.~   "
7813|NCT02954939|"~     This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on~     lymphocyte subsets in patients with proliferative lupus nephritis. Patients with~     biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone~     (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA)~     (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months,~     followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte~     subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks~     after induction treatment. The lymphocyte subsets and serum cytokine profiles will be~     compared between the two treatment regimens, and also correlated with subsequent risk of~     relapse.~   "
7815|NCT02954913|"~     Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary~     colorectal tumour and liver metastases within 12 months, is a common problem faced by~     colorectal and hepatobiliary surgeons.(Adam) The traditional approach is to perform staged~     resections unless the liver resection required is limited (i.e. small wedges of peripheral~     lesions). The downside of performing staged vs. simultaneous resections is that patients~     must undergo two major operations instead of one, which limits a patient's ability to return~     to their pre-surgical state of health in a timely fashion, increasing health care costs~     (Ejaz) and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous~     approach include longer operating room times potentially increasing the major postoperative~     complication rate including blood transfusions, surgical site infections, anastomotic leaks~     and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that~     simultaneous resection of the colon and rectum along with liver resection of any magnitude~     is feasible and safe.(Silberhumer) Although encouraging, this data comes from specific~     patients from a highly selected institution, results that are perhaps not generalizable.~      This proposal is a feasibility study consisting of a pilot single arm prospective study at~     two different large-volume Hepatobiliary Centres of patients with synchronous colorectal~     cancer with liver metastases undergoing simultaneous resection of the colon or rectum and~     liver to evaluate their complication rates (including the calculation of the comprehensive~     complication index), quality of life, cost evaluation, and proportion of eligible patients~     recruited over a 12-month period. The results of this pilot study will provide us with the~     information necessary to build a large multicentre randomized controlled trial comparing~     staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.~   "
7816|NCT02954900|"~     The purpose of this study is to evaluate a decision support website (RealRisks) designed to~     inform patients about breast cancer chemoprevention. It is coupled with a physician-centered~     (BNAV) decision support website as part of clinical workflow in the primary care setting.~     The investigator hypothesizes that improving accuracy of breast cancer risk perception and~     understanding of the risks/benefits of chemoprevention will enhance informed decision-making~     and uptake of breast cancer prevention strategies in the primary care setting.~   "
7817|NCT02954887|"~     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,~     and an open-label extension phase. The open-label extension phase only will be described in~     this record. All participants will receive GWP42003-P.~   "
7818|NCT02954874|"~     This randomized phase III trial studies how well pembrolizumab works in treating~     triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere~     with the ability of tumor cells to grow and spread.~   "
7819|NCT02954861|"~     'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of~     the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During~     their recovery period, a significant number of patients experience delirium, a clinical~     syndrome of acute onset and fluctuant course.Though these deficits are often known to be~     transient without any permanent physical or neurological impairment, the experience can~     still psycho-socially affect these patients for a longer length of time even after~     discharge. The presence of delirium puts excessive, undesired strain on the patient, their~     families, health care providers and hospital resources.~      PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It~     is known to either develop immediately after the disturbing event or weeks and months later.~     The actual symptoms can be varied but are categorized in three sections: i.e.:~     re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').~      A problem that has such an impact on any patient is worth investigating and understood~     better. Being in such a unique professional position, as a Clinical nurse practitioner, the~     investigator is ideally placed to conduct this study. In this study, the researcher will be~     focusing on the pre-operative risk factors in developing delirium, actual incidence of~     delirium and follow the patients post operatively to evaluate the after effects of delirium~     in the form of PTSS.~   "
7820|NCT02954848|"~     The purpose of this study is to evaluate the efficacy and safety of oral TAK-438 10 mg~     once-daily in the treatment of non-erosive gastroesophageal reflux disease~   "
7821|NCT02954835|"~     The purpose of this study is to compare wound infection rates between negative pressure~     therapy (Prevena) and the traditional sterile dry dressing among patients undergoing~     vascular surgery involving groin incisions.~   "
7822|NCT02954822|"~     A randomized, open-label, multiple dosing, three treatment, three period, two sequence~     clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of~     evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects~   "
7823|NCT02954809|"~     The purpose of this study is to determine the effects of morning bright light therapy on~     fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.~   "
7824|NCT02954796|"~     This study tests the safety of a drug called SGN-CD352A, to find out what its side effects~     are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple~     myeloma.~   "
7825|NCT02954783|"~     Background and purpose: The purpose of this study is to investigate the effect of exercise~     on intratumoral natural killer (NK)-cell variability in patients with localized prostate~     cancer undergoing radical prostatectomy.~      The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural~     killer (NK)-cell infiltration in patients with localized prostate cancer, and that the~     infiltration is greater in patients performing High Intensity Interval Training compared to~     moderate intensity training.~      Currently there is a lack of randomized controlled trials examining different types of~     exercise in patients with localized prostate cancer. Moreover there is a need for studies~     including biological measurements to allow a full assessment of the effect of exercise on~     diverse biomarkers and mechanistic pathways, which may influence cancer survival.~      Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for~     radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.~      Methods: In this randomized controlled pilot study 30 patients with localized prostate~     cancer undergoing radical prostatectomy will be included and randomized to either High~     Intensity Interval Training (HIIT) exercise intervention, Moderate-Intensity Aerobic~     Exercise and Resistance Training (MI-AT+RT) intervention (standard recommendations) or~     observational control receiving usual care for a total period of 8 weeks.~      All patients will undergo assessments at inclusion (baseline) and after 8 weeks (5-7 days~     prior to surgery,) respectively.~      Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory~     fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality~     of life by self-report questionnaires; oral glucose tolerance test; fasting blood sample~     measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and~     inflammatory markers.~      Also, the investigators will collect blood samples before, during and after an acute~     exercise bout in order to explore the acute systemic changes in exercise-regulated~     biomarkers.~      Biological tissue from tumor (primary prostate biopsies) will be retrieved from the~     respective local pathological departments and from the perioperative prostate specimen and~     sent to protocol analyses.~   "
7826|NCT02954770|"~     This is a one year follow up survey study after a Fitbit® challenge study to determine if~     wearing a Fitbit® motivates residents to increase their physical activity. This study seeks~     to determine if residents continue to use the Fitbit® after one year.~   "
7938|NCT02953301|"~     The purpose of this study is to determine whether resminostat will be able to delay or~     prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary~     Syndrome that have recently achieved disease control with previous systemic therapy.~   "
7827|NCT02954757|"~     Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual~     bleeding, and menstrual pain. Although surgical intervention is the definitive treatment,~     some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU)~     therapy is receiving increasing interest in the management of uterine adenomyosis by~     inducing focal thermocoagulation of the fibroids. Results obtained by various research~     groups have shown that HIFU treatment is safe, effective and is highly acceptable to~     patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU~     in the treatment of uterine adenomyosis.~      In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the~     study inclusion criteria will be invited to participate in the study which involves the use~     of HIFU in the management of the adenomyosis. Background information of the patients such as~     age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic~     medical disease will be collected. Subjects will also be asked to complete an eight-item~     section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and~     menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of~     women.~   "
7828|NCT02954744|"~     Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual~     bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the~     definitive treatment, some women prefer to have their uterus preserved. High-intensity~     focused ultrasound (HIFU) therapy is receiving increasing interest in the management of~     uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by~     various research groups have shown that HIFU treatment is safe, effective and is highly~     acceptable to patients. The main objective of this study is to evaluate the therapeutic~     efficacy of HIFU in the treatment of uterine fibroids.~      In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study~     inclusion criteria will be invited to participate in the study which involves the use of~     HIFU in the management of the fibroid. Background information of the patients such as age,~     body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic~     medical disease will be collected. Subjects will also be asked to complete an eight-item~     section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which~     evaluate the effect of the fibroid on the quality of life of women.~   "
7829|NCT02954731|"~     Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have~     been proven just as effective as traditional diagnosis specific CBT manuals. The~     investigators have translated and modified the The Unified Protocol for Transdiagnostic~     Treatment of Emotional Disorders (UP-CBT) to make it applicable as group therapy in Danish~     Mental Health Service and a naturalistic trial of this manual has shown promising results.~     As the use of one manual instead of several diagnosis specific manuals in regional clinics~     could simplify logistics and reduce waiting time, the investigators want to compare group~     UP-CBT with diagnosis specific group CBT.~      Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial~     (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each~     intervention arm, recruited from three Danish regional Mental Health Service Clinics.~   "
7830|NCT02954718|"~     Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood.~     The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain,~     stiffness and limitations on daily living activities (DLA) in varying degrees. However, the~     information about prevalence of symptoms, disorders, DLA limitations, participation~     restriction and options of treatments for upper extremity involvement in JIA are limited. It~     has been reported that improvements of upper extremity functions were achieved by~     video-based games (VBG) in various disease groups. However, in the literature, no study has~     been found about effectiveness of WBG in children with arthritis. The aim of the study was~     to investigate effects of task-oriented activity training (TOAT) with VBG versus activity~     training in real life on activity performance and participation in children with arthritis.~     Participants with upper limb involvement in JIA were randomly assigned to the activity~     training in real life group (group I) and TOAT with VBG in real life group (group II). The~     actual materials and rehabilitation kits will be used for activity training in group 1, the~     DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity~     muscle strength and grip, range of motion, upper limb functions, activity, participation and~     quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG~     improves the activity performance and physical functions and increases the participation,~     via being stimulative and interactive in order to provide feedback and to increase interest~     and motivation.~   "
7831|NCT02954705|"~     Activation of neutrophils by ANCA (Anti-Neutrophil Cytoplasm Antibodies) and subsequent~     microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis~     (AAV), a severe autoimmune disease that often targets the kidney. There is no specific~     treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage~     renal disease, requiring dialysis and kidney transplantation. In addition, there is no~     reliable biological marker of the disease activity available, which makes the diagnostic,~     follow-up and treatment of patients difficult. Therefore, the identification of new~     therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to~     improve AAV patients care and to ameliorate their renal outcome.~   "
7832|NCT02954692|"~     Primary Objective:~      To assess the mean change in HbA1c (glycated haemoglobin).~      Secondary Objectives:~      To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:~        -  Targeted HbA1c;~        -  Targeted fasting self- monitoring blood glucose (SMBG);~        -  Hypoglycemic events;~        -  Adverse events;~        -  Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire~          status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);~        -  Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in~          subgroup patients.~   "
7833|NCT02954679|"~     This descriptive and declarative study will help to find out consumption rates, all~     psychoactive substances taken together, among 18-25 year olds. More specifically, it will~     allow assessment of the extent of the cognitive enhancement phenomenon among students in~     France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of~     cognitive performance).~   "
7939|NCT02953288|"~     To investigate the genetic mutations of patients with thyroid carcinoma and find molecular~     targets for therapy.~   "
7834|NCT02954666|"~     Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus~     node dysfunction, and functional atrioventricular block have been published. Investigators~     have developed a more limited and specific approach of CNA, called cardio-neuromodulation~     (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through~     partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an~     innovative anatomic strategy. The feasibility of CardNM has already been tested in our~     center in a limited first study in humans (CardNMH1), with a favorable outcome for the~     patients involved. The results of CardNMH1 have been submitted for publication. The purpose~     of this second study of CardNM in humans (CardNMH2) is to collect more procedural and~     clinical data in well-defined patient groups.~   "
7835|NCT02954653|"~     Two part, dose escalation and dose expansion study. Open label, multi center, non~     randomized, multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent~     PF-06747143 in sequential dose levels of adult patients with refractory or relapsed AML in~     order to establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or~     maximally permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in~     combination with standard of care chemotherapy in adult patients with AML.~   "
7836|NCT02954640|"~     In order to accelerate the identification of genes responsibles of PID, and to improve the~     diagnosis of PID, the research team would like to validate a rapid and targeted method of~     high-throughput sequencing, on 301 genes, known to be involved in PID.~   "
7837|NCT02954627|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counseling, after which patients will be randomised to~     receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic~     guidance on re-introducing regular foods and a focus on continued motivation to engage in a~     healthy lifestyle.~      This substudy aims to investigate any changes in the carotid intima media thickness (CIMT)~     assessed by ultrasound in relation to an initial 8-week weight loss intervention.~   "
7838|NCT02954614|"~     Background: Physical activity (PA) is a key component in health promotion and prevention of~     overweight. Interventions delivered in after-school programs (ASP) have the potential to~     become a means of ensuring PA among young schoolchildren. This requires a motivational~     climate, allowing for self-determination and the intrinsic values of the activity, on the~     activity's character of play. ASP staff could be trained in stimulating all children in~     physical activities in their everyday life. Physiotherapists in primary care possess~     knowledge of motor development and learning, and are important contributors to an ASP-based~     physical activity intervention.~      Aim: To develop a complex intervention that emphasizes physical activity play, and to~     examine through a cluster-randomized trial the extent to which the intervention promotes PA~     and health-related quality of life and prevents overweight in a population of young~     children. We aim to increase the knowledge and autonomy supportive skills among ASP staff~     members, enabling them to promote physical activity through play among all first graders in~     ASP.~      In addition to investigate if the children benefit from receiving autonomy support, we aim~     to study whether the ASP staff themselves benefit from giving autonomy support in terms of~     increased need satisfaction and autonomous motivation for work.~      The intervention: Includes training of ASP-staff members in the fundamental principles of~     self-determination theory and practical applications for motivating young children in PA~     through play. Information will be given on the benefits of a physically active lifestyle and~     the staff will be encouraged to map opportunities for PA in their local ASP and to~     incorporate strategies to increase PA through play among the children throughout the day.~      Methods/design: A complex intervention using a mixed methods approach will be developed and~     evaluated. A pilot trial will assess the potential of this approach and provide information~     necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized~     controlled trial (RCT) will together with qualitative interviews and observations, evaluate~     the effectiveness of the intervention. Outcomes will be measured at baseline (September~     /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1~     year after the end of the intervention (May 2018)~   "
7839|NCT02954601|"~     This study will enroll approximately 30 adult subjects with T2DM from age 20 to 75~     inclusive.~      Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind~     placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will~     include three treatment assignments for each of three treatment Periods according to the~     randomization scheme.~   "
7840|NCT02954588|"~     A growing body of evidence demonstrates that increased adipose mass, especially visceral~     adipose tissue, contributes directly towards an increase in systemic inflammation,~     (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin~     resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are~     a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic~     intermediates derived from glucose and lipid oxidation. In addition to the overwhelming~     amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular~     dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue~     contributes to the dysregulation of adipokines and the development of insulin resistance.~      The investigators want to examine, in a double-blind randomized placebo controlled parallel~     study, the physiological effect of a dietary intervention with pyridoxamine in abdominally~     obese persons.~   "
7841|NCT02954575|"~     The purpose of this study is to obtain additional data on the safety and efficacy of Wilate~     in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII~     concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs,~     thus supplementing the existing database to obtain approval of Wilate for the indication~     hemophilia A in the USA.~   "
7842|NCT02954562|"~     In this study, people will be undergoing brain scans with functional magnetic imaging (fMRI)~     while they perform an emotional regulation task that involves observing either neutral~     images or images known to induce negative emotions, with instructions either to view~     passively or attempt to reduce the negative affect associated with the images. Resting state~     brain scans (with no explicit task) will also be acquired. Heart rate variability will be~     measured during these resting state scans. While in the scanner, subjects will also listen~     to prerecorded audio scripts about life stresses for themselves and for another person with~     instructions to practice compassion for themselves or for others. In yet another task, they~     will respond to pictures known to produce positive and negative emotions and perform an~     attention related task. The scans will take place once before and at least once after~     undergoing sessions of methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain~     scans will happen three times: an initial scan before placebo or MDMA-assisted~     psychotherapy, a second scan after either two placebo or two MDMA sessions (depending on~     whether the subject was in the placebo or MDMA group), and one final scan after the~     conclusion of three active MDMA sessions.~   "
7940|NCT02953275|"~     The purpose of this study is to determine the synergistic effect and clinical benefits of~     vedolizumab and pentoxifylline in the management of patients with inflammatory bowel~     disease.~   "
7843|NCT02954549|"~     A genomics-based approach will target specific genes that may explain the response in~     biomarkers and symptoms before and after supplementation. One objective is to generate~     evidence-based recommendations for vitamin D supplementation in Soldiers who often~     experience musculoskeletal disorders and immune dysfunction impacting physical performance~     and military readiness. The investigation is designed to address these specific aims: 1)~     explore vitamin D status in 105 Service Members to determine common symptoms associated with~     deficiency; 2) examine the effect of vitamin D levels on gene expression from select genes~     known to influence metabolism, bone density, and immune function; and 3) evaluate changes in~     gene expression between groups receiving high or low supplementation, and compare to healthy~     controls. Follow-up at 15 months will evaluate circulating vitamin D.~   "
7844|NCT02954536|"~     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in~     combination with trastuzumab and chemotherapy, has on the patients' esophagogastric cancer.~   "
7845|NCT02954523|"~     This is a study for patients with advanced non-small cell lung cancer with changes to their~     cancer cells called EGFR mutations. Mutated EGFR is important in the growth of cancer cells.~     Medical studies have shown that patients with EGFR mutation-positive lung cancer gain more~     benefit from targeted therapy drugs such as EGFR inhibitors than with standard chemotherapy.~     However, a significant proportion of patients carrying these sensitizing mutations do not~     respond well to the first-generation EGFR-TKIs (erlotinib and gefitinib), indicating the~     existence of intrinsic resistance mechanisms. Moreover, despite initial response to~     EGFR-TKIs, acquired resistance is inevitable in all patients.~      The investigators have recently shown that Cripto-1 overexpression in EGFR mutant NSCLC~     contributes to the intrinsic resistance to EGFR-TKIs through activation of the SRC oncogene.~     They have also shown that a combination of an EGFR-TKI (both erlotinib and osimertinib) and~     a Src inhibitor are synergistic in Cripto-1 overexpressing tumors in the laboratory.~      This study will be testing a combination of two drugs, dasatinib and osimertinib, to~     overcome resistance to EGFR-TKIs. Osimertinib (AZD9291) is a third-generation EGFR-TKI,~     which selectively blocks the activity of EGFR mutants, but spares that of wild type. The~     advantage of using osimertinib is that it inhibits not only the sensitizing EGFR mutations,~     but also the T790M mutant, which is the most common mechanism of acquired resistance.~     Dasatinib is a potent, orally available ABL1/SRC TKI, approved for the treatment of chronic~     myeloid leukemia (CML) in first-line and in patients with imatinib-resistant disease or~     intolerant, and is being actively studied in patients with advanced solid tumors.~      The first part of the study will involve finding the highest dose of dasatinib that can be~     given with osimertinib without causing severe side effects, finding out the side effects~     seen by giving dasatinib at different dose levels with osimertinib, and measuring the levels~     of dasatinib and osimertinib in blood at different dose levels. The second part will~     determine the effects of the combination of dasatinib and osimertinib and determine if the~     amount of Cripto-1 protein in your tumor or blood makes you more likely to have a good~     response to the combination of dasatinib and osimertinib.~   "
7846|NCT02954510|"~     There are no current alternatives to diagnostic contrast-requiring imaging for patients with~     an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to~     nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury.~     Ferumoxytol-enhanced imaging may offer an alternative approach.~   "
7847|NCT02954497|"~     PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Infant~     Jarvik 2015 versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This~     study will enroll 88 subjects, 44 in receiving the Jarvik 2015 VAD and 44 receiving the~     EXCOR®, at up to 22 sites in the US and Canada.~      IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at~     procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months~     post-procedure.~      The primary objective of this investigational device exemption (IDE) clinical investigation~     is are to (1) assess the safety of the investigational Jarvik 2015 through the evaluation of~     reported serious adverse events (SAEs) while on ventricular assist device (VAD) support up~     to the first 180 days post-implant and (2) explore the probable benefit of the~     investigational Jarvik 2015 by evaluating overall survival in the absence of severe~     neurologic impairment.~   "
7848|NCT02954484|"~     This study aims to provide high quality evidence from a double-blinded, randomized~     controlled trial on the efficacy of perioperative pregabalin in reducing morphine~     requirements, improving pain scores and reducing chronic neuropathic pain when compared with~     placebo for primary total knee arthroplasty. It hence aims to improve on choice of analgesia~     adjuncts for total knee arthroplasty.~   "
7849|NCT02954471|"~     This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian~     participants diagnosed with breast cancer between 2007 and 2013 and with available human~     epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected~     through 2015.~   "
7850|NCT02954458|"~     This study will follow subjects who completed the TED-C14-006 study. The purpose of this~     study is to evaluate the long-term safety and efficacy of teduglutide in pediatric subjects~     with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to~     eligible subjects, regardless of treatment received in TED-C14-006.~   "
7851|NCT02954445|"~     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of B-cell derived malignancies.~   "
7852|NCT02954432|"~     The purpose of this study is to assess the effects of tDCS in combination with TUS for the~     treatment of pain and functional limitations in subjects with NSCLBP. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
7853|NCT02954419|"~     This prospective cohort study is designed to examine the association between blood and urine~     biomarkers (including genetic variants) and long-term kidney disease progression among 2000~     Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73~     m2).~   "
7854|NCT02954406|"~     The purpose of this study is to determine the maximum tolerated dose or recommended Phase 2~     dose of TAK-659 when administered in combination with bendamustine, bendamustine +~     rituximab, gemcitabine, lenalidomide, or ibrutinib.~   "
7855|NCT02954393|"~     The aim of this multicenter randomized clinical trial is to compare the clinical,~     microbiological and immunological effects of the adjunctive use of systemic metronidazole~     plus amoxicillin administered in different phases of the treatment of generalized chronic~     periodontitis.~   "
7856|NCT02954380|"~     The aim of our study is to investigate if LTCM's are superior to implantable loop recorders~     in detecting atrial fibrillation after pulmonary vein isolation. This study will provide~     insights on a possible alternative for detection of arrhythmia.~   "
7857|NCT02954367|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     meat hydrolysates extract with a regular endurance training programme on (a) body~     composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f)~     haematological markers in endurance athletes~   "
7858|NCT02954354|"~     The primary objective of this study is to evaluate the efficacy of a single, oral dose of~     S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients~     with uncomplicated influenza virus infection.~   "
7860|NCT02954328|"~     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous~     every day phenomena. For example, people frequently walk while talking on a cellphone or~     drive while talking to a passenger. Often, the performance of one or more of these~     simultaneously performed tasks may deteriorate when another task is carried out at the same~     time, even in healthy young adults. This reduction in performance is referred to as the DT~     deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in~     age-matched controls. In this population the DT cost impairs the gait pattern, as~     manifested, for example, in increased gait variability, exacerbating instability and fall~     risk.~      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance~     following tDCS.~      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will~     increase DT performance and prefrontal activation.~   "
7861|NCT02954315|"~     We hypothesize that regular consumption of almonds will augment the long chain fatty acid~     profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the~     appearance of facial wrinkles in post-menopausal women.~   "
7862|NCT02954302|"~     This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be~     reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard~     gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).~   "
7863|NCT02954289|"~     Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new~     cases estimated for 2015. Prostate cancer patients often live with uncomfortable side~     effects of treatment, such as a decrease in bone health, weight gain, and challenges to~     their interpersonal relationships. Nutrition can improve outcomes for PCa survivors;~     however, dietary interventions for prostate cancer patients are limited. Therefore, this is~     a feasibility study that tests the impact of an innovative intervention to promote healthy~     nutrition and weight control for prostate cancer survivors and their partners.~      The objectives are to assess the feasibility of the intervention, specifically:~        -  Accrual, retention and adherence, and participant satisfaction~        -  Candidate measures for primary outcomes in future studies~      The intent is to evaluate how well the classes work and identify ways to make them more~     successful. At the end of the study, the investigators will know if this approach shows~     merit to be tested further through a randomized controlled trial.~   "
7864|NCT02954276|"~     the trial is a randomized, open label, crossover, single-administration bioavailability~     study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual~     tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.~   "
7865|NCT02954263|"~     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-1439 in healthy adult and elderly subjects~   "
7866|NCT02954250|"~     Background: According to the World Health Organization, one million people die by suicide~     each year worldwide and the rate of attempted suicide is ten times greater. A less known~     fact is that suicide is 3 times more frequent in elderly adults compared to younger~     counterpart. Unfortunately, predicting and preventing suicidal behaviours (SB) in general,~     and in elderly in particular, remain difficult. Clinical, biological and genetic data~     suggests that SB may be best understood according to a stress-vulnerability model where,~     more vulnerable individuals are at increased risk of committing a suicidal act when~     experiencing (mostly social) stress. Vulnerability to SB has also been associated with~     specific (i.e. distinct from comorbid psychiatric disorders like depression) neurocognitive~     alterations. However, the neurocognitive basis of suicidal behavior in elderly has been more~     rarely investigated.~      Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many~     psychiatric symptoms in many different populations, given that this therapy reduces~     cognitive creativity. Thus, this pilot study aims at addressing the SB in older adults with~     a Modified Mindfulness Based Cognitive Therapy (MMBCT).~      Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people~     with SB, but also, effective to treat depressive symptoms and suicidal ideation.~     Additionally, we will explore the changes in cognitive testing.~      Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults~     with depression and suicidal behaviors at the Douglas Mental Health University Institute.~     Patients with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation~     (Scale for Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The~     meditation intervention will involve doing seated 90minute/week meditation exercises for 8~     weeks. The primary outcomes will examine feasibility and acceptability of the treatment. The~     secondary outcome measures will scores in HAM-D and we will control for any important~     covariates differing between groups, (e.g. age, sex, # medical illnesses).~      Perspectives: Implementation of these interventions could potentially prevent many~     consultations to psychiatry/mental health professionals. Increase quality of life, decrease~     medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging~     population, this could translate to substantial savings in health costs.~   "
7867|NCT02954237|"~     The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™~     Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug~     after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single~     arm, post approval, observational study. The clinical study will be conducted at up to 35~     sites in China. Approximately 343 subjects will be enrolled in this study.~      The total study duration is expected to be approximately 7 years. Patients who have~     non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral~     anticoagulant; or patients who experience stroke or other thromboembolic event despite~     taking warfarin.~      Scheduled office visits occur at (45 days+ 2 weeks), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and~     24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6~     weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.~   "
7868|NCT02954224|"~     Delirium is a common complication in elderly patients following surgery. Patients who~     develop delirium after surgery are at increased risk for serious complications, and even~     death.This multi-centre randomized controlled trial will enroll elderly patients scheduled~     for elective hip/knee replacement surgery.The objective of this trial is to identify~     obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP~     treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium~     in elderly patients undergoing elective hip and knee replacement surgery.~   "
7869|NCT02954211|"~     The purpose of this study is to determine the characteristics that distinguish responders~     from nonresponders in people with stroke receiving rTMS combined with physical therapy to~     improve hand function. Investigators hypothesize that those who improve the most will be~     characterized by larger evoked brain signals in the stroke hemisphere and lower scores on~     the Beck Depression Inventory indicating less depression. Medications, sex, age, type of~     stroke, location of stroke, duration of stroke and baseline hand function will also be~     compared.~   "
7951|NCT02953132|"~     The purpose of this study is to investigate the safety and tolerability of ascending single~     and multiple oral doses of MT-4129 in healthy subjects.~   "
7871|NCT02954185|"~     Preliminary evaluations have been completed and resulted in patients and therapist~     indicating positive outcomes through increased patient engagement, asynchronous~     communications (i.e. messaging) between therapists and patients, and objective assessment~     and monitoring of exercises performed by the patients. The investigator's hypothesis is that~     patients using the Wellclub device and application in addition to in-clinic physical therapy~     will be more compliant with their home exercise programs and have the same or better~     functional outcomes than patients with similar conditions who use in-clinic care only.~   "
7872|NCT02954172|"~     A randomized, double blind, multicenter phase3 study .~   "
7873|NCT02954159|"~     The purpose of this study is to assess if a combination therapy of tacrolimus and~     vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to~     severe UC, and its effect on long and short-term outcomes including colectomy rate.~     Secondary aim of this study is to assess the safety of tacrolimus as an induction agent in~     patients with UC when used in combination with vedolizumab.~   "
7874|NCT02954146|"~     The purpose of this study is to examine feasibility, tolerability, utilization, and~     effectiveness of using the SupportTeam mobile application in the context of Cognitive~     Behavioral Therapy (CBT) for veterans with PTSD.~   "
7875|NCT02954133|"~     The aim of the study is to determine if, and to what degree photobiomodulation treatment~     with OrthoPulse has an effect on the rate of tooth movement during alignment for patients~     receiving Invisalign orthodontic aligner treatment.~   "
7876|NCT02954120|"~     Background: The aim of this study was to investigate the levels of malondialdehyde (MDA),~     total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and~     saliva samples in female patients with chronic periodontitis (CP) and to compared healthy~     individuals.~      Materials and Methods: A total of 88 women were into four groups each which were consisted~     of twenty-two subjects. Groups were designed as periodontally and systemically healthy women~     (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-),~     systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum~     and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS,~     8-OHdG levels were measured as biochemically.~   "
7877|NCT02954107|"~     This longitudinal study will focus on the cognitive and brain development of children with~     absence epilepsy. In addition, the investigators aim to identify prognostic factors for~     cognitive deterioration and/or poor seizure control in these children.~   "
7878|NCT02954094|"~     TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual~     clinical practice. TARGET-HCC will create a research registry of participants with HCC~     within academic and community real-world practices in order to assess the safety and~     effectiveness of the entire spectrum of current and future therapies across diverse~     populations.~   "
7879|NCT02954081|"~     Patient treatment preference and treatment satisfaction of physicians and patients comparing~     fumaric acid ester therapy with subsequent apremilast treatment~   "
7880|NCT02954068|"~     This double-blind, randomized controlled trial will evaluate the effect of the route of~     administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will~     be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection~     IM~   "
7881|NCT02954055|"~     This is a multi-center, randomized phase II trial that will randomise women with~     ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or~     locally relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of~     vinorelbine plus cyclophosphamide and capecitabine, or the conventional paclitaxel~     monotherapy.~   "
7882|NCT02954042|"~     The purpose of this investigation is to compare the clinical benefits of using the Pelvital~     product, in comparison to a sham procedure as a noninvasive treatment for female~     incontinence~   "
7883|NCT02954029|"~     Arterial access is the key step during the endovascular treatment of cardiovascular~     diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad~     using chitosan in patients undergoing percutaneous procedures with arterial approach. Two~     cohorts will be included in this study: transradial and transfemoral cohort. Among the~     transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the~     BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized~     and oxidized regenerated cellulose matrix that achieves hemostasis by activating the~     intrinsic coagulation pathway. The hypothesis will be tested among the transradial cohort~     that the combined use of a hemostasis pad and a compression device is superior to that of a~     compression device only in terms of hemostasis in patients who underwent tranradial coronary~     procedures.~   "
7884|NCT02954016|"~     To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System~     for treatment of adults with severe obesity.~      The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35~     and ≤ 50 kg/m2 who have failed more conservative weight loss methods.~   "
7885|NCT02954003|"~     The purpose of this study is to collect clinical data to support the use of the ValenTx Endo~     Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.~   "
7886|NCT02953990|"~     This study will provide information about the feasibility, acceptability, and preliminary~     effects of a biobehavioral self-management approach for perinatal depressive symptoms. This~     line of research will contribute to the body of knowledge about adjunctive therapies for~     depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child~     outcomes. Ultimately, this will contribute to the development and implementation of~     theoretically driven depression prevention/ resiliency building interventions and~     measurement of appropriate biobehavioral outcomes to determine the effectiveness of~     interventions.~   "
7887|NCT02953977|"~     SMSC will inform the design and implementation of culturally informed, community-based~     lifestyle interventions for diabetes prevention in AI men in our partner communities and~     elsewhere, as well as in men of other minority groups who experience a heavy burden of~     diabetes.~   "
7934|NCT02953353|"~     The overall goal of this proposal is to evaluate the efficacy of transcranial direct current~     stimulation (tDCS), a noninvasive neuromodulation technique, to facilitate weight loss and~     weight loss maintenance in obesity. This is a novel clinical research study that examines~     the therapeutic potential of an innovative biomedical treatment for weight loss.~   "
7888|NCT02953964|"~     The purposes of the study are:~        -  To evaluate the effectiveness of a perceptual-based training program in enhancing~          cognitive and everyday functioning of older adults with mild cognitive impairment and~          mild dementia~        -  To evaluate the effectiveness of a semantic-based training program in enhancing~          cognitive and everyday functioning of older adults with mild cognitive impairment and~          mild dementia~   "
7889|NCT02953951|"~     The hemolytic product free-hemoglobin (fHb) reduces nitric oxide (NO) bioavailability. The~     present study aims to establish whether transfusions of stored allogenic blood or~     intraoperative autologous salvaged blood result in increased circulating fHb levels and NO~     consumption with effects on arterial NO-dependent blood flow measured in isolated left~     mammary artery rings and by peripheral artery tonometry in patients undergoing CABG surgery.~   "
7890|NCT02953938|"~     This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The~     primary objective will be assessed by the difference in the mean number of ranibizumab~     injections applied up to Month 11 between the 2 treatment arms. Patients will be randomized~     in a 1:1 ratio to 1 of the 2 treatment arms; i.e. Arm 1 ranibizumab monotherapy, Arm 2~     ranibizumab with Grid&Direct short pulse laser photocoagulation combination therapy. There~     will be 3 periods in this study: Screening Period (visit 1), Treatment Period (visit 2 to~     Visit 13) and Follow-up Period (visit 14). In addition to screening and Baseline (visit 2),~     there will be monthly visits from Month 1 to Month 12. This study will include male and~     female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to~     BRVO. Assuming an approximate 20% drop out rate, approximately 70 patients will need to be~     screened to have at least 56 patients found eligible and commencing treatment in the trial.~   "
7891|NCT02953925|"~     The survey aims to support health policy making, this survey aims to comprehensively assess~     the capability and quality of PHC in different regions in China. The study is based on the~     China PEACE MPP network, including about 4000 rural and urban primary health care~     institutions scattered over 31 provinces in Mainland China. The investigators intended to~     enroll about 30,000 PHC healthcare providers. Meanwhile, the investigators drew a random~     samples (>50,000) of patients from MPP high-risk of CVD population. In this survey, data on~     structure, process, and outcome of PHC system in China will be collected by questionnaires,~     specified by organization, healthcare providers and patients. Meanwhile, the investigators~     will collect the original documents from participating PHC institutions, covering the~     aspects of finance, employment, essential medical list (EMS), public health service report~     and prescriptions. The investigators will analyze data in align with key indicators, to~     assess the capability and quality of PHC across different regions in China.~   "
7892|NCT02953912|"~     To show whether One Shape rotary system differs from Reciproc reciprocating system in~     postoperative pain in patients with symptomatic irreversible pulpitis.~   "
7893|NCT02953899|"~     The purpose of this project is to pilot contingency management as an adjunct treatment to~     counselling as usual using internet delivered video-conferencing applications for remote~     disordered gamblers. This project further investigates the impact of adding contingency~     management to counselling to improve counselling attendance and retention and uses~     internet-delivered approaches to assist rural and remote disordered gamblers gain access to~     counselling treatments.~   "
7894|NCT02953886|"~     The study will compare bacteria levels in cavities before and after silver diamine fluoride~     (SDF) treatment.~   "
7895|NCT02953873|"~     Compare the difference in dose-normalized trough and total daily dose necessary to reach the~     steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African~     American kidney transplant recipients.~   "
7896|NCT02953860|"~     A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to~     fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive~     and Her2 normal.~   "
7897|NCT02953847|"~     3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing~     FDCs vs a single drug comparator in healthy volunteers~   "
7898|NCT02953834|"~     This study examines how a naturally occurring peptide called Kisspeptin might regulate blood~     sugar and insulin levels.~   "
7899|NCT02953821|"~     Subjects with active systemic lupus erythematosus (SLE) will be randomized to receive Acthar~     or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at~     multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28~     Joint Count~   "
7900|NCT02953808|"~     This is the first study in which GSK2315698 will be administered in Japanese population. The~     primary objective of the study is to investigate safety and tolerability, pharmacokinetics,~     and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a~     single center, double-blind, randomized, placebo-controlled, dose-ascending study.~      Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3~     groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose~     levels of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to~     be administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be~     separated by a washout period of at least 8 and 10 days, respectively.~      Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive~     either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.~      A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort)~     complete the study. The duration of participation for any subject in this study will be~     approximately 59 days.~   "
7901|NCT02953782|"~     This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal~     antibody which is designed to block a protein called CD47, which is widely expressed on~     human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find~     and destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for~     treatment of certain types of colorectal cancer as well as head and neck cancer.~      The major aims of the study are: (Phase 1b) to define the safety profile and to determine a~     recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to~     evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients~     with advanced colorectal cancer.~   "
7902|NCT02953769|"~     Comparison of ventral hernia repair using standard wound care versus Prevena.~   "
7903|NCT02953756|"~     Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases~     (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain~     Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning,~     and may affect therapy compliance and quality of life in general, a full understanding of~     cognitive functioning in patients with BM after SRS is essential.~      CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10~     BM accepted for treatment with Gamma Knife radiosurgery (GKRS).~   "
7904|NCT02953743|"~     The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic~     (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular~     Carcinoma (HCC).~   "
7905|NCT02953730|"~     The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human~     Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents~   "
7906|NCT02953717|"~     Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients~     with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been~     increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS~     is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM~     without cognitive side effects is becoming more important, as more patients live longer due~     to better systemic treatment options. There are no published randomized trials yet directly~     comparing GKRS to WBRT in patients with multiple BM, including objective neuropsychological~     testing.~      CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT~     in eligible patients with 11-20 BM.~   "
7907|NCT02953704|"~     The purpose of this prospective, longitudinal, noninterventional study is to describe~     clinical characteristics, evolution of disease burden, and treatment patterns in patients~     with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).~   "
7908|NCT02953691|"~     The overall objective of this proposal is to explore the association between the~     administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B~     galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative~     period. The investigators' central hypothesis is subjects who consume GOS in the~     perioperative period will demonstrate lower levels of salivary cortisol before, during, and~     after their operative procedures. In addition, the investigators expect subjects who consume~     GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the~     investigators hypothesize that subjects who consume perioperative GOS will perform better on~     tests of cognition in the postoperative period. Such a finding would be beneficial in that~     administration of GOS in the perioperative period offers a safe and inexpensive adjunct to~     current medical management of perioperative anxiety.~   "
7909|NCT02953678|"~     The purpose of this study is to assess the efficacy of ruxolitinib in combination with~     corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host~     disease (GVHD).~   "
7910|NCT02953665|"~     The purpose of this study is to test the efficacy and safety of liraglutide in the treatment~     of patients with idiopathic Parkinson's disease (PD).~   "
7911|NCT02953652|"~     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and~     pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R~     PTCL).~   "
7912|NCT02953639|"~     This multicenter study will assess the effects of 24 weeks of basmisanil treatment on~     cognition and functioning of stable CIAS participants treated with antipsychotics.~   "
7913|NCT02953626|"~     Postpartum depression is common, yet only 20% of women seek treatment. Online support groups~     are a potential means of providing accessible mental health care during this time. Mother~     Matters is a 10-week online psychotherapy group for women with postpartum depression &~     anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of~     proceeding to a large-scale RCT evaluation of the Mother Matters intervention.~   "
7914|NCT02953613|"~     The goal of this study is to correlate both plaque and % lipid core content assessed by~     NIRS-IVUS (Imaging technique) to plaque burden and % lipid core content in coronary~     computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary~     arteries.~   "
7915|NCT02953600|"~     Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per~     year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat,~     long-term, and severe chronic hepatitis would be more possible progressed into liver~     cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would~     progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC.~     In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis~     phase.~   "
7916|NCT02953587|"~     The purpose of this study is to determine if the altered nutrient exposure to the GI tract~     after bariatric surgery reveals a negative incretin effect of ghrelin.~   "
7917|NCT02953574|"~     The purpose of this study is to determine if the daily performance of a 7 step bedtime~     nursing protocol for hospitalized people living with dementia is feasible and if it has an~     effect on bedtime and daytime variables.~   "
7918|NCT02953561|"~     This clinical research study has 2 parts: Part A and Part B.~      The goal of Part A is to find the highest tolerable dose of avelumab that can be given in~     combination with 5-azacytidine to patients with relapsed or refractory AML. The goal of Part~     B is to learn if the highest tolerable dose of this drug combination found in Part A can~     help to control the disease.~      The safety of this drug combination will also be studied in both parts of the study.~   "
7919|NCT02953548|"~     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,~     and an open-label extension phase. The pilot phase only will be described in this record. 2~     cohorts of 5 participants will be enrolled sequentially. All participants will receive~     GWP42003-P.~   "
7920|NCT02953535|"~     Comparative randomized, single dose, three way three sequence two treatment partial~     replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from~     Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets~     (Gilead Sciences, Canada)~   "
7935|NCT02953340|"~     The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in~     patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to~     prevent and reduce Neutropenia that is associated with cancer chemotherapy.~   "
7921|NCT02953522|"~     The C677T polymorphism in the MTHFR gene is related to several significant biochemical~     changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12~     and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the~     emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially~     folate, is characterized by being beneficial for individuals with this genetic alteration to~     possess anti-inflammatory function, act on and oxidative stress play an important gene~     function. The aim of this study was to evaluate the influence of the C677T polymorphism of~     the MTHFR gene and the effect of a diet containing folate on oxidative stress, lipid profile~     and homocysteine levels in adult women are overweight or obese. This is an intervention~     study, double-blind, held in a city in northeastern Brazil. The study included 48 adult~     women (20-59 years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated~     the CAT levels, MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition~     genotyping for the C677T polymorphism in the MTHFR gene and the food consumption by the food~     recall 24 hours, being divided by randomization into two groups received daily for 8 weeks,~     300g vegetables rich in folate containing 191 ug and 90 ug of this nutrient.~   "
7922|NCT02953509|"~     This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a~     monoclonal antibody which is designed to block a protein called CD47, which is widely~     expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune~     system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is~     used for treatment of non-Hodgkin's lymphoma and other types of cancer.~      The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of~     sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in~     combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in~     combination with rituximab in patients with indolent lymphoma or diffuse large B-cell~     lymphoma as measured by the overall response rate.~   "
7923|NCT02953496|"~     The research study is designed to assess the technical feasibility and safety of~     percutaneous administration of vonapanitase to the superficial femoral or popliteal artery~     in patients with PAD.~   "
7924|NCT02953483|"~     The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They~     will be connected to a ventilator and preservative solution will be circulated through it .~     Blood will be added to the fluid depending on the group to which the lungs are allocated and~     its effects on lung function will be seen~   "
7925|NCT02953470|"~     The aim for the study is to examined the effect of an individually tailored integrated~     behavioral medicine in physiotherapy intervention including functional exercise, for older~     adults, having chronic musculoskeletal pain, living alone and dependent on formal care.~      The study is a pragmatic randomized controlled trial with one intervention group and one~     control group. The intervention is a 12-weeks home-based program. The intervention consists~     of an individually tailored intervention and aims to enhance ability to perform everyday~     activities by improving physical function and reduce pain-related beliefs and pain-related~     disability. The comparison group achieves general advice about physical activity. All~     participants will be tested at baseline, a post-assessment at 12 week and a three month~     follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical~     function by Short Physical Performance Battery.~      Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the~     goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health~     related quality of life.~   "
7926|NCT02953457|"~     This phase I/II trial studies the side effects and best dose of olaparib when given together~     with durvalumab and tremelimumab and to see how well they work in treating patients with~     ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation~     that has come back or has not responded to treatment. Drugs, such as olaparib, may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors~     cells with BRCA1 or BRCA2 mutation. Monoclonal antibodies, such as durvalumab and~     tremelimumab, may help stimulate the immune system in different ways to attack and stop~     tumor cells from growing. Giving olaparib with durvalumab and tremelimumab may work better~     in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.~   "
7927|NCT02953444|"~     This study will assess the efficacy of brief mindfulness practices on improving mental~     health in adults who are currently in treatment for mental health concerns. From online~     instructional videos, each participant will learn a thirty-second or three-minute~     mindfulness practice that is to be performed at least three times daily over two weeks.~   "
7928|NCT02953431|"~     This is an early phase clinical trial to test the efficacy of elevating lung volume with~     positive expiratory pressure (PEEP) as a controller therapy for asthma in patients with a~     BMI ≥ 35 kg/m2.~      There will be two phases to this trial.~      Phase I:~      In the first phase we will determine the optimal duration of PEEP that is effective as a~     controller therapy in asthma. Up to 9 participants will complete this this phase.~      Phase II:~      The 2nd phase will be a randomized double-blinded controlled trial of PEEP 0 versus PEEP 10~     (using the duration of PEEP determined in phase I) as a controller therapy for asthma.~     Twenty participants will complete this phase.~   "
7929|NCT02953418|"~     Multicenter, prospective cohort clinical trial in greater China~   "
7930|NCT02953405|"~     Prescription and Persistence of Antithrombotic agents in Acute Ischemic Stroke or Transient~     Ischemic Attack Patients with MCA(Middle Cerebral Artery) Disease.~   "
7931|NCT02953392|"~     Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus~     floor elevation technique to insert one implant will be selected. The purpose of this~     multi-center, prospective, double blind, and randomized investigation is to analyze a~     platform switched implant when placed at limited maxillary residual bone height with low~     bone density compared to a platform matching implant with or without bone graft material.~   "
7932|NCT02953379|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the~     mometasone nasal gel in the treatment of allergic rhinitis.~   "
7933|NCT02953366|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the~     mometasone nasal gel in the treatment of allergic rhinitis.~   "
7962|NCT02952989|"~     This study will examine the safety profile of SGN-2FF. The study will test increasing doses~     of SGN-2FF given daily to small groups of patients.~   "
7941|NCT02953262|"~     Patient-facing eHealth technologies are those that connect patients and the healthcare~     system, and include online patient portals. Although many organizations are adopting patient~     portals, there is limited understanding of how the different portal features help improve~     health outcomes. This study is designed to develop and test an intervention to improve~     adoption and use of patient portal features for diabetes management.~   "
7942|NCT02953249|"~     Dental treatment to individuals with diabetes mellitus, particularly type 1 diabetes (T1DM),~     has always represented a challenge to the dentist. The literature provides some scientific~     evidence showing that diabetes is a risk factor for the occurrence of oral opportunistic~     infections, abnormal bone metabolism and delay in tissue repair, but with varying degrees of~     evidence.~      Hyperglycemia, as well as diabetes, are known as risk factor for post-surgical infections,~     so maintaining the glycemic control in the postoperative period has been standard to health~     care. However, there are few studies on the impact of the glycemic control in the repair~     process after tooth extractions. And, to our knowledge, there aren't evidences that~     infections resulting from oral surgery are more frequent in individuals with diabetes or~     that the antibiotics prophylaxis is needed for these individuals before invasive dental~     procedures.~      Some prospective studies show that people with diabetes, especially type 2 (T2DM), do not~     exhibit higher frequency of complications in repair process after tooth extractions compared~     to healthy individuals without diabetes. Recently, the study conduct by Fernandes et al.,~     2015, found higher frequency of delay on epithelial covering of the alveolus after 21 days~     of tooth extraction in individuals with T2DM, comparing to a control group. Delay was not~     related to infection and on the day 60th after surgery, all alveolus were totally~     epithelized. One of the author's hypothesis for the delay in the alveolar epithelialization~     on the participants with T2DM was the possible reduction of Epithelial Grow Factor (EGF) in~     saliva of these individuals. Some studies already demonstrated the reduction in salivary~     detection of EGF in individuals with diabetes.~      There aren't prospective studies in the literature at our disposal, that evaluated~     intraoperative complications of tooth extractions of teeth already erupted in individuals~     with T1DM, or even post tooth extraction healing and the chronology of epithelialization of~     the alveolus and its relation with the degree of salivary EGF.~      The aim of this study is to evaluated the intraoperative events and the post- tooth~     extraction healing, regarding the chronology of the repairing events and the occurrence of~     postoperative complications in individuals with T1DM compared to a control group. Besides,~     this study intend to relate the time of complete epithelial covering of the alveolus with~     the EGF collected by whole stimulated saliva.~   "
7943|NCT02953236|"~     This study aimed to verify the mechanical and clinical effects of instrumented massage on~     myofascial trigger points of trapezius muscle in adult subjects.~   "
7944|NCT02953223|"~     To assess the frequency and nature of adverse events in infants fed a free amino acid based~     infant formula.~   "
7945|NCT02953210|"~     The use of opioid during surgery can cause side effects and may delay hospital discharge.~     Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and~     and the time of discharge. In this compared controlled randomized study the aim is to~     evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting,~     postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia~     care unit and hospital.~   "
7946|NCT02953197|"~     Treatment of cancers of the head and neck, including oropharyngeal tumours, usually consist~     of a combination of radiotherapy and chemotherapy, although surgery may also play a part.~     Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck~     cancers often respond well to radiotherapy in the first instance and a proportion of~     patients will be cured by this treatment. However, not all of the cancer cells are destroyed~     by the combination of radiotherapy and chemotherapy and, in some patients, the cancer does~     come back.~      Studies have suggested that more efficient killing of cancer cells, and therefore, better~     cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this~     was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new~     radiotherapy delivery technique that allows better shaping of the dose to the areas that~     need irradiating with the potential for fewer side effects. If the investigators use IMRT to~     deliver an intentionally higher dose of radiation (called a boost) to small selected areas~     whilst, at the same time giving standard treatment doses to the remaining areas, this~     approach is called IMRT dose-painting. These selected areas can be identified by a scan~     called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a~     'PET' scan) which is a type of scan that can give information about the activity of a~     cancer.~      The purpose of this study is to find out whether the investigators can use IMRT~     dose-painting to boost the dose to the region inside a tumour which appears most active on~     18F-FDG-PET. If this study shows that this approach is well-tolerated, then the~     investigators may be able to improve cure rates with this treatment. This would need to be~     tested in a subsequent study.~   "
7947|NCT02953184|"~     The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4~     cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be~     compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles~     followed by paclitaxel or docetaxel 4 cycles[noted in National Comprehensive Cancer Network~     (NCCN) guideline].~   "
7948|NCT02953171|"~     The aim of the present study is to assess the efficacy of two different probiotic products,~     lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel~     syndrome.~   "
7949|NCT02953158|"~     This study will compare two energy reduced diets; one diet will include one Haas avocado/day~     while the other diet will follow the usual American dietary pattern. All subjects will~     receive a dietary plan that reduces their usual intake by 500kcal/day with the same~     percentage of fat, protein and carbohydrates. The results from this study may help to~     explain if eating one Haas avocado/day can achieve at least equivalent weight loss when~     compared to the usual American diet.~   "
7950|NCT02953145|"~     Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is~     surgery to correct the underlying anomaly. Children born with cleft palate typically undergo~     surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure~     and the use of electrocautery (burning of the tissue). Other products are available to help~     lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a~     blood clot. When a fibrin sealant is applied there are a variety of potential benefits other~     than bleeding control. One of these is decreased pain post operatively It is the~     investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will~     decrease pain and enhance the recovery of children who undergo cleft palate repair.~      The proposed study will randomly select children undergoing cleft palate repair to have~     tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to~     have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon~     but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale~     will be used to score the pain of the children throughout their admission to the Stollery~     children's hospital. The amount of pain controlling medication required as well as time to~     discharge will also be recorded. Statistical analysis of the data will be performed using~     accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will~     less the amount of post operative pain experienced by children undergoing cleft palate~     repair.~   "
7952|NCT02953119|"~     Major abdominal surgery is a great stressor to patients and causes large physiological~     changes, leads to tissue trauma, immobility, psychological distress and reduced quality of~     life. Physical capacity appears to be an important predictor for postoperative recovery~     after major abdominal surgery. Prehabilitation is a concept that challenges the traditional~     models of recovery by initiating the recovery process preoperatively. Improvement of~     physical capacity by means of prehabilitation may facilitate better recovery after surgery.~     More specifically prior to major abdominal surgery, preoperative exercise therapy is~     associated with improved physical fitness of patients, but whether or not this results in~     fewer complications or faster convalescence remains unclear.~      The aim of the present study is to evaluate the impact of preoperative physical exercise~     training (prehabilitation) on postoperative recovery and clinical outcomes after major~     abdominal surgery.~   "
7953|NCT02953106|"~     Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The~     primary objective is to assess the additive effects of using combined intranasal fluticasone~     propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients~     with persistent asthma and allergic rhinitis, receiving inhaled steroid.~   "
7954|NCT02953093|"~     The investigators are studying the effects of acarbose on muscle and adipose gene~     transcription in older adults.~   "
7955|NCT02953080|"~     PROTOCOL SUMMARY Abstract Current estimates point towards a huge increase in the number of~     people that are eligible to start ART in Uganda and globally. As many of the newly eligible~     patients are largely asymptomatic, there are concerns about adherence and retention of these~     individuals and especially those starting ART with a higher CD4 counts. Urgent information~     is required to plan for implementation of most recent WHO and National guidelines in the~     most cost effective manner as well as maximizing retention of HIV positive individuals in~     care and achieving virological suppression.~      We plan to undertake research designed to see if we can optimize adherence, virological~     outcomes and HIV knowledge, in order to give an overall increased quality of life in~     vulnerable populations starting or established on ART in Kampala, Uganda. We will test~     implementation of an open source software-based tool to send text messages and to give~     access to an interactive voice response system to support self-monitoring and provide health~     information using patients' mobile phones.~      We aim to undertake an open labeled randomised trial at two sites: the IDI which is an urban~     center of excellence in HIV care, and Kasangati Health Center, which is a peri-urban public~     health care facility. The project aims to enroll patients starting ART, already established~     on first line ART or switching to second line ART. We will include special populations~     including pregnant women, discordant couples and young people. The estimated length of the~     project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR~     LIFETM m-health technology (CFL2015.01 or higher). CFL2015.01 provides text messages or~     Interactive Voice Response (IVR) functionalities, a technology that allows a computer to~     interact with humans through the use of voice and tones input via keypad, including pill~     reminders, clinic visit reminders, health tips and functionality to support symptom~     reporting.~      The Primary Objective of this study is to determine the effect of the CFL2015.01 tool on~     quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of~     the intervention, all patients will undergo quality of life assessment, which will be~     repeated at months 6, 12 and 24 months. The scores will be compared to assess the effect of~     the tool on quality of life. The Secondary Objectives are virological outcomes baseline, 6,~     12 months and 24 months, retention in care, aversion of early treatment failure, disease~     knowledge, clinic attendance and cost analysis.~   "
7956|NCT02953067|"~     This trial is designed to compare different treatments on Lisfranc fractures. The trial~     consist of 2 different strata. Stratum 1: In mild injuries the comparison is between~     conservative treatment and operative treatment with open reduction and internal fixation~     (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with~     open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome~     measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and~     Ankle.~   "
7957|NCT02953054|"~     The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch,~     will provide adequate pain relief during the first 3 days following bunionectomy surgery.~   "
7958|NCT02953041|"~     The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either~     as monotherapy or in combination, on the methacholine dose-response curve. This will allow~     for further elucidation of the mechanisms of each drug in human participants.~   "
7959|NCT02953028|"~     Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during~     sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep,~     increased risk for developing cardiovascular disease and increased risk of accidents caused~     by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to~     16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP).~     This is effective and must be used for life. However, CPAP-treatment might be uncomfortable~     for the patient, with poor compliance as a result. An alternative is Mandibular Advancing~     Splints (MAS), which is perceived as less troublesome and may initiate higher compliance.~     Through mapping of patient characteristics, the researchers investigate which patient-type~     benefits most from two different treatment-devices. The aim of the study is to assess how~     the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and~     impact on health related quality of life among patient diagnosed with mild/moderate OSA. All~     OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital,~     Northern-Norway (UNN) were invited to participate in the study. The sample size at~     completion of the study should be 140 patients. Participants in the trial were randomly~     allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data~     were collected through anamnesis, clinical examination, clinical photos, radiographs and~     questionnaires concerning general health related quality of life (SF36), oral health,~     cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness~     scale) and compliance.~   "
7960|NCT02953015|"~     Chronic migraine (CM) is a very disabling disorder with grave socioeconomic consequences.~     Pharmacological approaches can affect mechanisms of pain production, while rehabilitation~     such as Transcutaneous Electrical Nerve Stimulation and Manual Therapy may reduce the~     neuromuscular contributing factors. The main aim of the study is to evaluate the effects of~     cervical and thoracic manipulative techniques combined with OnabotulinumtoxinA prophylaxis~     on headache frequency in patients with Chronic Migraine (CM). The second aim is to evaluate~     the training effects on the intensity of headache attacks, analgesic consumption, cervical~     range of motion, TrPs sensitivity and disability. The hypothesis is that the manipulative~     treatment would alleviate CM symptoms and, in turn, decrease the analgesic consumption.~   "
7961|NCT02953002|"~     In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial.~     After signing an informed consent a blood sample will be obtained from each participant. The~     investigators will measure the thrombin generation in plasma assessed by the calibrated~     automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be~     calculated. The relation between SOFA score and thrombin measurements will be determined.~   "
7965|NCT02952950|"~     In this project 3 studies examined two possible explanations and one possible preventive~     intervention to early cessation of exclusively breastfeeding in premature infants.~      Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a~     third higher than in the milk from the mother who delivers on time. The nutritional~     composition changes over time and the content of protein decrease. Therefore the premature~     infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing~     content of protein can made up by adding, while it is more difficult when the infant is~     exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is~     associated to a fewer number of days where the premature infant is exclusively breastfed.~      Study 2 The premature infant is characterized with immature muscle with a low tension and~     therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of~     milk from mother to child is an interaction between the mothers and her milk ejection reflex~     that establish a positive pressure on the milk and the child that have to establish a~     vacuum. The hypothesis is that the premature infants suction power is too weak to establish~     sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can~     be related to a fewer number of days where the infant is exclusively breastfed.~      Study 3 The premature infants low muscle tone and its immaturity also influence on the~     organization and the quality of movements, marked as neuro motor processes. These processes~     form the oral motor base supporting movement which involves the infant ability to establish~     vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before~     the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to~     create intra oral vacuum and thus the power to transfer milk from the breast, thereby~     extending the number of days when the infant is exclusively breastfed.~      200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1~     the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant~     suction is assessed by vacuum measurement. In study 3 the families are randomized to an~     intervention or control group and parents off 100 infants are guided by occupational~     therapists in a program of oral stimulation of their child.~   "
7966|NCT02952937|"~     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR~     GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg~     administered regular diet and (2) determine the safety and tolerability of a single dose of~     GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg~     administered regular diet.~   "
7967|NCT02952924|"~     This study is sponsor-open, investigator-blinded, participant-blinded, randomized,~     placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study that~     will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of~     RO7049389 following oral administration in healthy volunteers and chronic HBV infected~     participants. The effect of food on the PK of RO7049389 and the effect of multiple dosing of~     RO7049389 on the PK of a single oral microdose of midazolam will be evaluated. The study~     will be conducted in two parts: Part 1 (1a [SAD cohort], 1b [Food-effect SAD cohort], 1c~     [MAD Cohort]) in healthy volunteers and Part 2 (Proof of mechanism [POM]) in chronic HBV~     infected participants.~   "
7968|NCT02952911|"~     This prospective pilot study will assess the feasibility of remote participant monitoring~     using digital technology in participants with MS and healthy controls. At the enrollment~     visit, the participants as well as the healthy controls will be provided with a remote~     patient monitoring solution which includes preconfigured smartphone and smartwatch. The~     configured smartphone and smartwatch pair will contain application software that prompts the~     user to perform various assessments, referred to as active tests and passive monitoring.~     Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,~     electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ),~     MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive~     monitoring will be done to collect metrics on gait and mobility throughout the daily life of~     participants in a continuous and unobtrusive manner.~   "
7969|NCT02952898|"~     This research study is being done to compare the safety and effectiveness of GDC 695 (test~     drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to~     establish that these two drugs work better than placebo in the treatment of actinic~     keratosis.~   "
7970|NCT02952885|"~     Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on~     the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess~     in turn causes overproduction of another hormone called insulin-like growth factor-1~     (IGF-1). IGF-1 levels are currently the most widely accepted measure of disease activity.~      In Canada, medical therapy with a type of medicine called somatostatin analogues (SSA),~     such as octreotide and lanreotide, is recommended for treatment of acromegaly. However,~     studies have shown that a significant number of patients who take SSA medications alone~     remain with elevated levels of IGF-1 in their blood.~      Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the~     investigators plan to study whether strict control of IGF-1, by adding or optimizing the use~     of PEGV, results in a significant health benefits to patients who still have modestly high~     levels of IGF-1 in their blood.~   "
7971|NCT02952872|"~     The project seeks to develop an effective computer-delivered brief intervention to reduce~     alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of~     the intervention will be tested with manipulation of common factors (empathy & positive~     regard), use of a voice, and use of an animated narrator. Participants will include 352~     undergraduate students randomly assigned to one intervention condition; follow-up~     assessments will take place at one and 3 months. The main outcome will be means drink per~     day over the past 30 day.~   "
7972|NCT02952859|"~     Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after~     colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland,~     1,172 new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20%~     of pancreatic cancer patients present at a disease state that allows surgical resection~     while 30% have locally advanced, unresectable disease and 50% show distant metastases. While~     the latter two are currently treated in a palliative setting with median survival of at most~     6-12 months, patients who undergo tumor resection with curative intentions also achieve only~     5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought~     to be chemoresistance, early establishment of metastatic disease, and importantly, high~     rates of R1 resections. Up to 80% of pancreatic resections have positive resection margins~     which are often found within the vascular groove and/or at the retroperitoneal margin, close~     to the superior mesenteric artery. This high rate of positive margins is only found after~     meticulous pathological work-up and is normally not detected after standard assessment of~     the specimen. However, the clinical importance of the high positivity of resection margin is~     even more highlighted as patients undergoing portal vein resection despite negativity of~     portal vein invasion after regular pathological work-up show significantly better survival~     compared to patients without portal vein resection. In sum, given the overall poor prognosis~     despite tumor resection, auxiliary treatment strategies to improve long-term outcomes are~     desperately needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a~     non-thermal ablative modality that allows local tumor destruction with sparing vital~     structures like arteries, venous vessels, as well as the bile and pancreatic duct. There is~     increasing evidence that IRE for locally unresectable pancreatic cancer is effective with an~     increase in local progression free survival , distant progression free survival and overall~     survival compared to historic controls.Data on margin accentuation IRE are sparse while in a~     recent study published by Martin et al showed that margin accentuation among patients with~     borderline resectable disease can be performed safe and efficacious if the treatment can be~     performed with a high degree of technical ability and skill set.~   "
8501|NCT02946008|"~     This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of~     neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate~     cancer patients.~      Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks~     total.~   "
7973|NCT02952846|"~     The study is a prospective interventional study with three main aims:~        1. Describe the frequency and severity of withdrawal syndrome in a population of~          paediatric intensive care patients.~        2. Test whether implementation of an algorithm for tapering of analgosedation changes the~          frequency and severity of withdrawal symptoms in the same population.~        3. Investigate how the health care providers experience having to adhere to such an~          algorithm.~   "
7974|NCT02952833|"~     This study is a dose de-escalation study to evaluate the safety of ZPIV. Three dose levels~     may be evaluated. The entire duration of each subject's participation is approximately 14~     months including recruitment and collection of data on the safety and reactogenicity of the~     study vaccine and samples for the assessment of immunogenicity. This study is expected to~     take approximately 30 months to complete from initiation through availability of a final~     report on the primary outcomes of safety and the secondary outcomes of humoral immunity to~     ZIKV. The Primary objectives of this study are to 1. Assess the safety and reactogenicity of~     a homologous prime boost regimen of ZPIV given at three different dose levels in a dose~     de-escalation format, and 2. Compare the safety and reactogenicity profile of ZPIV after~     each vaccination and between dosage groups.~   "
7975|NCT02952820|"~     The key objectives of this study are to determine, using sleep diaries, whether lemborexant~     at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset,~     subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia~     disorder.~   "
7976|NCT02952807|"~     to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter~     for induction of labor~   "
7977|NCT02952794|"~     To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic~     mucosal band ligation (EMBL) for early cancer.~   "
7978|NCT02952781|"~     The purpose of this research is to test the clinical value of a new P-wave sensitive~     recording vector compared to a standard ECG limb lead II vector from similar easy-to-use~     long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring~     (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the~     electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the~     CAM system improves arrhythmia diagnosis.~   "
7979|NCT02952768|"~     Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to~     have a role during resuscitation. The aims of this study were to develop a novel,~     resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a~     short curriculum and to assess the feasibility.~      The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a~     3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal~     ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for~     the C-A-B and searching the possible cause of cardiac arrest.~      A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour~     small-group hand-on training. Assessments were performed, including a written test, the US~     image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the~     multi-center emergency physicians who attended the US-C-A-B curricula were enrolled~     prospectively.~   "
7980|NCT02951793|"~     Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic~     drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation~     requirements.~      Study design: A prospective observational study, in a medical ICU of a tertiary university~     hospital.~      Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders~     Identification Test (AUDIT-C), smoking history and prior medication use was given to the~     patient or closest family members.~      Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening~     Checklist and Richmond Agitation-Sedation Scale.~   "
7981|NCT02951780|"~     The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and~     what effects LY3185643 and rGlucagon have on the body. This study will also help to~     determine if LY3185643 is safe and well-tolerated.~      This study will last at least 35 days, not including screening.~   "
7982|NCT02951767|"~     This phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment~     in participants with locally advanced or metastatic urothelial bladder cancer. Participants~     will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants~     who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will~     contain participants who have progressed during or following a prior platinum-based~     chemotherapy regimen. The results of the second cohort are reported separately~     (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous~     (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1~     will continue until disease progression per Response Evaluation Criteria in Solid Tumors~     Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2~     will continue until loss of clinical benefit or unmanageable toxicity.~   "
7983|NCT02951754|"~     Methylphenidate (MPH) is the first-line pharmacological treatment for adults with~     Attention-Deficit/Hyperactivity Disorder (ADHD). Nevertheless, there is considerable~     interindividual variability regarding the dose required, tolerability and response rates to~     MPH. The aim of this study is to address the clinical and genetic predictors of MPH~     treatment outcomes in ADHD.~   "
7984|NCT02951741|"~     Revision total hip replacement arthroplasty is a surgery having intra- and postoperative~     substantial blood loss. The investigators will investigate the relationship between the~     various hematologic variables and postoperative bleeding volume.~   "
7985|NCT02951728|"~     This is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma~   "
7986|NCT02951715|"~     Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were~     included. Each subject underwent an otoscopic examination, distortion product otoacoustic~     emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level~     analyses. After 2 months of treatment with zinc, all tests were repeated.~   "
7987|NCT02951702|"~     The purpose of this study is to determine if oral vancomycin used as primary Clostridium~     difficile prophylaxis can reduce the incidence of this infection in high-risk patients.~   "
8502|NCT02945995|"~     The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients~     previous treated with periacetabular osteotomy~   "
7988|NCT02951689|"~     Purpose: To evaluate the influence of probiotic supplementation on body composition and~     other markers of health in occupational shift-workers.~      Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a~     shift-working schedule.~      Procedures (methods): In a randomized, placebo-controlled intervention, subjects will~     complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as~     well as a 6-week intervention period. Prescreening will include written informed consent, a~     health history questionnaire, baseline anthropometric measures, assessment of resting heart~     rate, and exercise protocol familiarization. Baseline testing will involve body composition,~     a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be~     randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of~     supplementation that includes 2 electronic contacts, followed by post-testing that will~     occur in the same fashion as baseline testing.~   "
7989|NCT02951676|"~     This is a prospective, longitudinal, observational, cohort study investigating young adults~     undergoing surgical extraction of a wisdom tooth with and without antibiotics~     post-operatively. The prescription of antibiotics will be based on clinical judgment based~     on case complexity, trauma and length of procedure. No randomization will be performed.~     Saliva will be collected at seven observational time points ( Baseline, one week ,two weeks,~     three weeks , one month,three months and six months.) and Supragingival plaque samples will~     be collected at four observational time points ( Baseline , one week , one month, and 3~     months) .A control group of 15 subjects who do not undergo dental extractions or antibiotic~     treatment will be recruited after obtaining informed consent and will be followed up for the~     same seven time points..Routine standard care will be observed. No new medications are~     triedThe samples will be analysed for identification of bacterial genes using 16 S r RNA~     gene sequecing and QPCR for change in the antibiotic resistance genes overtime. Kindly note~     that in the current study the participants are patients who are already scheduled to undergo~     tooth extractions with or without antibiotic treatment based on clinical judgement by the~     clinician performing the extraction. ( These patients are on the waiting list for third~     molar extractions in the dental hospital concerned.)~      The participants will receive the intervention( Third molar extraction with /without~     antibiotics) in the same manner and intensity even if they are not enrolled for the study.~   "
7990|NCT02951663|"~     Purpose: To evaluate adherence, tolerability, and total protein intake in bariatric surgery~     patients provided with ready-to-drink protein supplements, and to evaluate the effects of~     supplementation on body composition, metabolism, and health outcomes.~      Participants: Patients scheduled to under go bariatric surgery aged 18-70 years old.~     Participants will be included if they agree to comply with the study protocol, are free of~     medical conditions that may contraindicate participation, and do not plan to become pregnant~     during the study.~      Procedures (methods): Participants will complete five laboratory visits for the current~     study (pre-screening (visit 1), baseline testing (visit 2), and return visits at 3 weeks~     (visit 3), 12 weeks (visit 4), and 24 weeks (visit 5) post-surgery). The treatment group~     will be given a 12 week supply of a high protein, low-carbohydrate, low-fat supplement to be~     taken once daily during days 3-7 post-surgery, and twice daily weeks 2-12. The treatment~     group will follow standard of care recommendations put forth by the physician-nutritionist~     team, but using the provided protein supplement to meet recommendations. The control group~     will be asked to follow the standard of care recommendations from the physician-nutritionist~     team.~      The primary study endpoints will be adherence, tolerability, and total protein intake in~     bariatric surgery patients provided with a 12-week supply of ready-to-drink protein~     supplements. Secondary outcomes will evaluate the effect of a protein supplement on body~     composition (lean mass, fat mass, percent body fat, visceral fat, muscle thickness), resting~     metabolic rate, clinical and endocrine blood values, functional fitness, and responses to~     questionnaires evaluating mood, satiety, functional independence, and health related quality~     of life.~   "
7991|NCT02951650|"~     This will be an open label multicenter study of the safety and efficacy of an active~     implantable VNS device in patients with Crohn's Disease.~   "
7992|NCT02951637|"~     The purpose of this study is to compare chemotherapy and gefitinib in combination with~     gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.~   "
7993|NCT02951624|"~     The primary aim of this study is to investigate the acute effect of the frequency and~     duration of breaks in sitting time on the metabolic risk factor profile.~   "
7994|NCT02951611|"~     60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective~     video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30~     patients in each group: 1. control group and 2. treatment group. Patients in treatment group~     will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at~     6h and 24h after surgery. Patients in the control group received only TIVA general~     anesthesia and sham electrical stimulation. Serum from patients of both groups will be~     collected at before surgery, 1h and 25h after surgery, respectively. Serum levels of~     TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured~     and compared between the two groups.~   "
7995|NCT02951598|"~     The purpose of this study is to learn about health care use, costs, and clinical outcomes~     over time for amyloid positive participants with early stages of AD in the United States.~     This study is for research purposes only, and is not intended to treat any medical~     condition. No study therapy(ies) for AD will be administered.~   "
8005|NCT02952729|"~     This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an~     intravenous infusion once every three weeks. The dose escalation part of the study will~     establish the maximum tolerated dose or recommended Phase 2 dose for in patients with~     advanced breast cancer and a HER2 immunohistochemistry (IHC) score of at least 1+ using a~     validated IHC assay. Upon completion of dose escalation, the cohort expansion segment of the~     study will consist of four parallel cohorts of different patients groups to confirm the~     maximum tolerated dose or the recommended Phase 2 dose and estimate the objective response~     in each of the patient populations.~   "
8006|NCT02952716|"~     The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after~     carbon monoxide poisoning~   "
8547|NCT02945410|"~     The purpose of this study is to determine if an increased protein intake can attenuate the~     suppression of metabolic and anabolic hormones during caloric restriction~   "
7996|NCT02951585|"~     Intra-articular hyaluronic acid injections, also known as viscosupplementation, are a~     treatment option for knee osteoarthritis that serves to restore the decreasing rheological~     properties of synovial fluid. KARTILAGE® CROSS is a visco-elastic gel of highly purified~     reticulated hyaluronic acid. It contains mannitol to provide an anti-oxidative action and to~     avoid hyaluronic acid depolymerization. Reticulation and mannitol increase the residency~     time of the product in the joint cavity then allowing a single injection in painful knee~     osteoarthritis patients.~      The US food and drugs administration (FDA) and European medicine agency (EMA), have recently~     published guidelines recommending a higher level of integration of biomarkers in the~     development and testing of new drugs to advance decision-making on dosing, time and~     treatment effect, trial design, and risk/benefit analysis. Biomarkers can be used not only~     in the process of drug development, but also in the future in assessment of individual~     patient's response to treatment.~      Several soluble biomarkers have been identified as potential candidates to predict or~     monitor the efficacy of intervention. Coll2-1, a degradation product of type II collagen,~     and Coll2-1NO2, a nitrated form of the Coll2-1 peptide have been studied in human~     osteoarthritis and entered the qualification process. Evidences demonstrated them to be~     pertinent and to be foresee as markers used for the diagnosis, the prognosis, the burden of~     disease and the monitoring of a treatment efficacy.~      The aim of this study was to provide with the first kinetic data regarding biomarkers in~     painful knee osteoarthritis patients treated with a new reticulated hyaluronic acid. The~     effects of the treatment were compared to those of saline solution. The primary endpoint was~     a specific osteoarthritis biomarker, Coll2-1. The secondary endpoints were the effects of~     the treatment or placebo on other biomarkers of osteoarthritis, its clinical efficacy and~     tolerance~   "
7997|NCT02951572|"~     As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in~     patients with neuromuscular disorders and thoracic deformations, we hope, by starting~     non-invasive ventilation and improving these symptoms, to increase their physical activity.~   "
7998|NCT02951559|"~     Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous~     etiology. Several causes have been recognized including neurodegenerative, vascular,~     infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders.~     While 30-50% of acute encephalitis remains without etiological definition, definitive~     criteria for neurodegenerative diseases are usually unavailable in vivo and possible or~     probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa~     that carries the specialized sensory organ for the modality of smell; the olfactory~     epithelium is composed of five principal cell types including olfactory receptor neurons. A~     sample of OM may be collected through a rhinoscopy-guided brushing: it is well-accepted by~     patients, not-contraindicated in patients with raised intracranial pressure and associated~     with almost no side-effects. Nasal brushing has recently been proposed for the in vivo~     diagnosis of Creutzfeldt-Jakob disease (CJD).~      Aims of the project are:~        1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU)~          specialists in the technique of nasal brushing;~        2. Conducting a prospective study comparing the use of nasal brushing with gold-standard~          criteria in the diagnosis of Encephalopathies;~        3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies.~      A prospective, case control, multicentric study enrolling 400 patients and 100 controls~     (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be~     diagnosed and followed according to international guidelines and local clinical practice.~     Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the~     diagnosis according to the clinical or radiological suspect.~   "
7999|NCT02951546|"~     Nonalcoholic fatty liver disease (NAFLD) is frequently associated with obesity. NAFLD~     genetic susceptibility involves Patatin Like Phospholipase Domain Containing 3 (PNPLA3)~     rs738409 and Transmembrane 6 Superfamily Member 2 (TM6SF2) rs58542926 polymorphisms.~      To date, biochemical mechanisms that affect the metabolic flexibility in obese NAFLD~     subjects, in presence or absence of genetic susceptibility, need to be better clarified.~      Different studies demonstrated that a dietary intervention, accompanied by a physical~     personalized training, significantly reduce either the hepatic fat content either insulin~     resistance in overweight and obese subjects, independently of weight loss.~      On these bases, the aim of the study is to evaluate metabolic flexibility in obese NAFLD~     subjects taking in account their genetics (presence or absence of PNPLA3 and TM6SF2~     polymorphisms) and the histopathological diagnosis of either simple steatosis or~     nonalcoholic steatohepatitis (NASH). In addition, the composition of gut microbiota will be~     evaluated.~      Finally, in this study, two distinct healthy dietary profiles accompanied by a personalized~     physical training, will be tested in order to comprehend whether and how healthy diets~     could be effective not only in the prevention, but also in the clinical treatment of NAFLD~     and other related conditions.~   "
8000|NCT02951533|"~     The purpose of the study is to compare the efficacy of Guselkumab with commercially~     available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult~     participants with moderate to severe plaque-type psoriasis who have not yet received any~     systemic therapy.~   "
8001|NCT02951520|"~     This study aims to describe and to evaluate the effectiveness (success rate) of a supine~     ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique~     (SOFT block) in knee surgery.~   "
8002|NCT02951507|"~     Comparison of new design of extra coronal castable precision attachment (OT unilateral~     attachment) and conventional partial denture in patient satisfaction and biting force.~   "
8003|NCT02952755|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20162 in Healthy Volunteers~   "
8004|NCT02952742|"~     This is a randomized, placebo-controlled crossover study. Participants will be actively~     participating in the study for 6 months, and enrolled in the study for up to 1 year. During~     the first phase of the study, the participants will be randomized into either the placebo~     group or treatment group for 8 weeks following 1 week of baseline data collection (no~     treatment). Following this first phase, a no-treatment washout period of at least 3 weeks~     will be implemented for all participants. After the washout period, the randomized groups~     will switch from treatment to placebo group, or placebo to treatment group for an additional~     8 week period. Hot flash frequency and severity will be documented using a daily hot flash~     diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life~     will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS)~     questionnaires.~   "
8134|NCT02950753|"~     Lactated Ringer's (LR) solution bolus is commonly administered in the emergency department~     setting to seriously ill patients. It is also common to obtain blood samples to determine~     serum lactate levels to aid in the assessment of the patient's degree of illness. This study~     endeavors to determine if serum lactate levels are affected by LR fluid administration in~     healthy adult individuals as compared to those who receive Normal Saline (NS). Healthy adult~     volunteers will be used as subjects so that the illness of hospital patients does not~     confound the results.~   "
8007|NCT02952703|"~     This study tests whether a smoking cessation intervention for pregnant women that extends~     postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the~     research environment that established its effectiveness (40% maintained biochemically~     verified 6-month abstinence). The research aim is:~      Is Striving to Quit more effective in achieving postpartum smoking cessation than First~     Breath, the current standard of care for pregnant women in Wisconsin who smoke?~      250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125)~     will receive the existing First Breath prenatal intervention. Those in Group B (Striving to~     Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home~     visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls,~     and up to an additional $100 in gift cards. The primary outcome will be biochemically~     confirmed smoking cessation at 6-months postpartum.~   "
8008|NCT02952690|"~     The purpose of this study is to evaluate the feasibility of endotracheal intubation via~     glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged~     between 1 and 5 year old.~   "
8009|NCT02952677|"~     This is a multi-centered randomized controlled trial to investigate the effects of~     Remind-to-Move (RTM) using wearable devices at home for promoting upper extremity recovery~     in stroke patients after discharge from subacute hospitals.~   "
8010|NCT02952664|"~     This study will employ two monitoring device prototypes. The devices are sensors containing~     accelerometers and gyroscope. The raw output data will be analyzed to determine when~     patients are moved or are repositioned in their beds. The data is captured within a modem~     which will correlate these movements with video recordings for interpretation by the~     research team. One sensor is wearable on the patient gown or sleepwear, and the other is~     placed underneath the frame of the hospital bed. The investigators propose a non-blinded~     trial with n=10 where all subjects will undergo the two devices. A video camera will be~     placed in each subject room for recording the repositioning events to correlate the monitor~     signals with the actual subject repositioning captured by the video. The goal of the trial~     is to validate the ability of each of the sensor prototypes to accurately detect when~     subjects are turned, in order to reduce stationary positioning which contributes to the~     incidence of pressure ulcers and to improve compliance with patient repositioning trials.~   "
8011|NCT02952651|"~     The purpose of this study is to evaluate predictability of a respiratory variation in pulse~     oximeter plethysmography for fluid responsiveness in children undergoing major surgery.~   "
8012|NCT02952638|"~     This study aims to test the hypothesis that dietary intake of phosphatidylcholine (PC) and~     lysophosphatidylcholine (LPC) acutely alters plasma lysophosphatidic acid (LPA) levels and~     autotaxin activity in normal weight and obese subjects.~   "
8013|NCT02952625|"~     This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art~     new imaging technique, into the radiotherapy treatment pathway of patients with head and~     neck cancer. Ultimately the investigators aim to establish appropriate scanning and image~     registration protocols, to allow progression to a randomized trial of adaptive radiotherapy~     dose escalation. The latter is thought to potentially improve outcomes in this group.~      Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx,~     planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study~     participants will have two PET/MRI scans, with the radiotherapy immobilization devices in~     situ. The first will be done prior to the start of radiotherapy, the second half way through~     treatment.~      Image quality will be assessed by comparing to standard diagnostic scans and different~     registration methods will be compared to establish the best way of incorporating PET/MR~     image data into the radiotherapy planning system. Patient tolerability and workflow~     considerations will also be qualitatively assessed. Furthermore, a planning study will be~     conducted to establish relevant treatment protocols for a subsequent dose escalation trial.~      PET/MRI is an exciting new technology with a lot of potential in the context of adaptive~     radiotherapy dose escalation. Within this pilot study the investigators aim to address the~     technical challenges of using it in this context prior to proceeding to a randomized trial.~   "
8014|NCT02952612|"~     Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of~     this tumor are not palpable and are identified either through pathologic examination or from~     imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary~     microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach.~     The purpose of this study is to understand more about the characteristics of papillary~     microcarcinoma, which has been known for the cancer slowly progression~   "
8015|NCT02952599|"~     According to current guidelines, duration of anticoagulant treatment after a venous~     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated~     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are~     limited to a maximum treatment duration of 12 months.~      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic~     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality~     and other drug related adverse events) of extended treatment with edoxaban up to 12 months~     in an unselected patient population in routine clinical practice.~   "
8016|NCT02952586|"~     This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor~     activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus~     SoC CRT alone in front-line treatment of patients with locally advanced head and neck~     cancer.~   "
8017|NCT02952573|"~     This is a phase 2 study to see how effective investigational drug, JNJ-42756493, is when~     given in combination with dexamethasone in two groups of patients with multiple myeloma~     (cancer of the plasma cells, a type of white blood cell present in bone marrow) that has~     relapsed (has come back after a period of improvement) or refractory (did not respond to~     standard treatment).~   "
8148|NCT02950571|"~     This study will be a randomized controlled trial that investigates the effectiveness of~     digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards~     servicing schizophrenia clients at CAMH. The effects on client experience will consider the~     domains of self-concept, interactions with healthcare staff, perception of space, and~     implications for the recovery process. The comparison of inpatient client experience with~     DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine~     the effectiveness of this type of environmental adaptation. This trial builds upon earlier~     work that demonstrated the feasibility of DPFs in this context.~   "
8018|NCT02952560|"~     Difficulty in managing the airway is the single most important cause of major~     anesthesia-related morbidity and mortality. The currently used clinical method of predicting~     airway difficulty used by anesthetists is limited and not very highly sensitive or specific.~     Any additional bedside method that increases its specificity and sensitivity would be~     valuable. This project is designed to study and measure the tongue thickness and oral cavity~     height by using an ultrasound scan and comparing them with the same measurements obtained by~     CT scan. These will also be compared to a more complicated measurements used in previous~     studies to investigate any correlation with the currently used clinical methods. This~     information will help us decide if ultrasound may help Anesthesiologists assess difficulties~     in airway management in a more accurate, precise and reliable simpler method.~   "
8019|NCT02952547|"~     The purpose of this study to Compare the safety and pharmacokinetics between~     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects~   "
8020|NCT02952534|"~     The purpose of this study is to determine how patients with metastatic castration-resistant~     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to~     treatment with rucaparib.~   "
8021|NCT02952521|"~     This is a research study to look at differences in tumor tissue from ovarian cancer patients~     that may help to determine response and resistance to treatments.~   "
8022|NCT02952508|"~     This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma(~     MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL),~     lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL),~     and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard~     therapy for their underlying malignancy.~   "
8023|NCT02952495|"~     This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of~     the effectiveness of A Toast to Health in Later Life! a web-based patient educational~     program designed to prevent hazardous and harmful drinking in older adults. The project's~     specific objectives are to~        1. provide reliable information on the extent to which A Toast to Health in Later Life!~          reduces alcohol-related risks and problems among older patients who drink and~        2. evaluate the extent to which these reductions are associated with increases in~          health-related quality of life, patient knowledge and self-efficacy and decreases in~          the use of health services and the costs of care.~   "
8024|NCT02952482|"~     To test if the routine newborn screening dried blood spots can be used to test if elevation~     of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy~     (ALD)~   "
8025|NCT02952469|"~     The purpose of this project is to collect initial data regarding biodistribution,~     reproducibility, and dosimetry for the radiotracer Ga-68 PSMA-HBED-CC, an agent which may be~     useful for the early detection of metastatic prostate cancer. Investigators will use a test~     and re-test design in all patients to determine reproducibility of lesion detection and~     signal intensity, and will include dynamic imaging in some patients for the purposes of~     dosimetry. Patients with known metastatic prostate cancer will be recruited and imaged on~     two occasions within the course of 15 days.~   "
8026|NCT02952456|"~     Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a~     higher mortality risk than the general population.~      The main objective of the study is to understand life experience of the disease or risks~     associated with epilepsy in patients with epilepsy, relatives of patients and bereaved~     families.~      Study design: Qualitative study (study based on interviews) Population: Three groups will be~     interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved~     family: relatives who contact the French sentinel network Réseau Sentinelle Mortalité~     Epilepsie (RSME) notifying an epilepsy-related death (regardless the cause of the death and~     the timeframe between death and interview). Patients with epilepsy: patients having a secure~     diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with~     epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the~     interview who consent to participate.~      Method: Semi structured in-depth interviews will be conducted by an experienced qualitative~     psychologist in face to face, at home, at the hospital or at any other place (depending on~     the choice of the participants). The interview topic guide will be centered on~     participants'personal experience. Interviews will be digitally recorded and will be~     transcribed by a secretary.~      The results of this study will be integrated in educational therapeutic programs regarding~     prevention of risks related to epilepsy.~   "
8027|NCT02952443|"~     The objective of this study is to evaluate a multi-component exercise intervention as an~     effective therapy to reverse pre-frailty phenotype in females age 65 or older. Participants~     will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index (CHS);~     the Clinical Frailty Scale (CFS); and a measure of self-paced normal walking speed.~     Participants undergo baseline evaluation to determine frailty phenotype and then those~     females who meet the pre-frailty criteria are randomized into one of two groups; 1)~     Multi-component exercise program, or 2) A control group who receives a monthly newsletter on~     tips for successful aging. The exercise group will participate in multi-component exercise~     program which will emphasize resistance training but also include aerobic, balance and~     flexibility components 3 times a week at 45 to 60 minutes/session for 16 consecutive weeks.~     The control group will be asked to maintain normal daily-living habits for the duration of~     the 16-week study.~   "
8028|NCT02952430|"~     Patients aged over 65 comprise more than half the emergency general surgical workload,~     however, available risk-prediction tools for such patients are extrapolated from younger~     cohorts. Research suggests that high pre-operative frailty scores correlate with increased~     post-operative mortality and morbidity. Validated frailty assessments may help identify high~     risk older emergency surgical patients, facilitating decision-making and informing patient~     choice.~      We propose the first prospective UK observational study assessing frailty as an independent~     predictor of outcome in the older surgical patient undergoing emergency laparotomy.~      Prospective data collection of patients over 65 undergoing emergency laparotomy will be~     performed in 20 NHS Trusts. Pre-operative frailty scores will be evaluated using the~     Rockwood Frailty Scale. Primary outcome measure is 30-day mortality. Secondary outcome~     measures are post-operative complications, altered independence status and length of stay.~      Results will be disseminated at national/international surgical meetings and published in a~     peer-reviewed journal.~   "
8029|NCT02952417|"~     The aim of this study was to estimate the impact of sex on relative survival and excess~     mortality following acute myocardial infarction (AMI) using a population-based cohort within~     a relative survival framework. Patient-level data concerning demographics, co-morbidity,~     cardiovascular risk factors and treatments at discharge were extracted from the Swedish~     Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated~     According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for~     patients hospitalized with acute coronary syndrome. Patients were followed-up for their~     vital status after AMI hospitalisation, with censoring at the end of follow-up on the 31st~     of December, 2013.~   "
8030|NCT02952404|"~     This is a retrospective cohort study. This two cohort study seeks to compare the incidence~     of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an~     educational workshop for improved perineal support.~   "
8031|NCT02952391|"~     Although PD is considered predominantly as a motor disease caused by loss of dopaminergic~     neurons, multiple studies indicate that cholinergic dysfunction already starts in early PD~     and is crucial for the development of dementia in addition to motor symptoms.Because of its~     crucial role in CNS functioning and neurodegenerative disorders, including PD, it is of~     great importance to get a better understanding of the cholinergic functioning in the brain.~     Pathways of acetylcholine synthesis, transport and release provide possible targets for in~     vivo imaging of the cholinergic system. However,previous approaches are considered as~     indirect biomarkers of cholinergic terminal integrity because they measure both pre- and~     post-synaptic expressions. The novel vesicular acetylcholine transporter (VAChT) tracer~     [18F]Fluoroethoxy-Benzovesamicol ([18F]FEOBV) provides a more direct measurement of~     presynaptic cholinergic function. The use of [18F]FEOBV as a Positron Emission Tomography~     (PET) imaging marker of cholinergic innervations has, however, only been studied in healthy~     human volunteers and no data is available on patients.~      With this study the differences in cholinergic function between PD patients and healthy~     aged-matched volunteers will be quantified. In addition the test-retest variability will be~     determined~   "
8032|NCT02952378|"~     Treatment with colloidal solutions has during long time been a cornerstone within intensive~     care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has~     been used more and more.~      One of these solutions is the hyperoncotic Albumin 20%. However there are still many~     aspects of the physiological effects of hyperoncotic albumin, that are not known. In this~     study physiological effects will be studied in burn patients and healthy subjects. The~     colloid osmotic pressure and the increase of the plasma volume will be measured in 15~     healthy subjects and in 15 burn patients. The effect on the plasma volume will be studied~     using hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin~     concentration will be measured directly and urin production will also be measured. Blood~     samples will be collected during 4 to 5 hours to achieve a profile over the changes.~   "
8033|NCT02952365|"~     The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent~     epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery~   "
8034|NCT02952352|"~     To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the~     Colville reservation through a community-based, culturally informed intervention, the study~     specifically aims to: 1. conduct focus groups and interviews with adult members of Colville~     tribe to inform the adaptation, manualization and implementation of a culturally informed~     diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness~     of a community-based, culturally informed diabetes prevention intervention by assessing~     between group changes in: Primary Outcomes: weight, dietary fat and caloric intake,~     vegetable consumption, and physical activity; Secondary Outcomes: physical fitness, blood~     pressure, lipids, self-reported quality of life; and, 3. evaluate the sustainability of the~     diabetes prevention intervention by assessing participant perceptions of program component~     fit through focus group discussions with participants in the intervention and telephone~     interviews with those who left the program.~   "
8035|NCT02952339|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to IMPAACT 2011.~   "
8036|NCT02952326|"~     Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the~     final irrigation protocol on necrotic mandibular premolars.~   "
8037|NCT02952313|"~     This study is being conducted to obtain outcomes data in subjects with severe to extreme~     class NOSE scores undergoing placement of the Spirox Latera Implant with or without~     concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.~   "
8038|NCT02952300|"~     the aim in this prospective in vivo randomized clinical trial to evaluate the influence of~     instrumentation technique ( reciprocation single file (wave one ) versus rotation single~     file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic~     treatment in single rooted lower premolars with symptomatic irreversible pulpits.~      According to the inclusion criteria the patients enrolled in the study and allocated~     randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic~     treatment is done at single visit. firstly the patient's medical and dental history is taken~     .the patient assign on informed consent. and then,anaesthetized and access cavity performed~     and root canal preparation is done by either two systems and then irrigation and obturation~     is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and~     the operator will recall the patient to check the records and follow up the patient.~   "
8039|NCT02952287|"~     The purpose of our study is to validate the accuracy of 4D PC flow method in quantification~     of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D~     PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR~     with 2D PC flow measurement.~   "
8040|NCT02952274|"~     The aim of this study is to compare the ball attachment to the locator attachment regarding~     the OHRQoL (oral health related quality of life) for completely edentulous patients~     retaining a mandibular overdenture with a midline placed implant~   "
8041|NCT02952261|"~     The purpose of this study is to explore the effectiveness of 3D printing in small pulmonary~     nodule localization by the design of an assisted device to facilitate the localization~     procedure.~   "
8042|NCT02952248|"~     The main objective of the dose-escalation part of the trial is to determine the safety and~     tolerability, Pharmacokinetic (PK), biomarkers, and efficacy, and to determine the Maximum~     Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of~     patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid~     malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of~     adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as~     changes to vital signs.~      Secondary objectives are the determination of the PK profile of BI 754091 after single and~     multiple doses of BI 754091, and the preliminary assessment of antitumour activity.~      In the dose-expansion part of the trial, the main objectives are to further assess the~     safety, efficacy, PK profile, and biomarkers of BI 754091 at the RP2D.~   "
8043|NCT02952235|"~     Use of two high SPF sunscreens under actual use conditions.~   "
8044|NCT02952222|"~     The primary aim of this study is to compare the propofol requirements of children who~     receive propofol with that of children who receive dexmedetomidine prior to propofol, for~     sedation for upper and lower endoscopic procedures.~   "
8045|NCT02952209|"~     This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after~     tooth extraction compared to extraction alone in the posterior maxilla. The results of this~     study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post~     extraction in the posterior maxilla region.~   "
8046|NCT02952196|"~     Addiction to amphetamine is characterized by alternating phases of intoxication and short~     abstinence, followed by recurrent drug-craving episodes which result in distress and~     relapse. Addiction involves a number of neurotransmission systems, including the~     endocannabinoid system (ECBS). Cannabidiol (CBD), the second most abundant component of~     cannabis, is known for its broad spectrum of physiological, anxiolytic and neuroprotective~     properties. It has been shown to have multiple therapeutic properties for treating anxiety,~     schizophrenia and interestingly CBD has been shown to be potentially helpful in treating~     addiction, due to its effects on various neuronal circuits involved in this disorder.~      The investigators overall hypothesis is that CBD is an interesting pharmacological contender~     to decrease amphetamine craving and treat amphetamine addiction.~   "
8047|NCT02952183|"~     Although nerve-sparing surgery has been introduced for female patients with the pelvic~     tumors, its success rate depends on operators. To achieve consistency of surgical procedure,~     It is necessary to adopt pelvic autonomic nerve monitoring technique.~      The Aims of this study is~        1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic~          system.~        2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I~        3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)~   "
8048|NCT02952170|"~     This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver~     disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic~     risk.~   "
8049|NCT02952157|"~     Postoperative sore throat is a complication after general anesthesia requiring endotracheal~     intubation. The investigators will evaluate the efficacy of lidocaine jelly application on~     the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.~   "
8050|NCT02952144|"~     Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD).~     Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M~     is produced by most cells in the body and is metabolized in the kidney in healthy~     individuals. However, in HD patients with renal dysfunction, β2M which is not removed~     entirely by HD accumulates excessively in the blood. Then it forms amyloid fibrils that are~     deposited in bones, joints, and soft tissues. The fibrils are further modified by advanced~     glycation end products (AGE), inducing local macrophage infiltration and production of~     cytokines leading to chronic inflammation and activation of osteoclasts. Consequently,~     severe complications with various symptoms are developed, which are collectively referred to~     as DRA.~      Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M~     selectively from the blood of DRA patients. The treatment is performed with Lixelle®~     connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle®~     column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands,~     which selectively adsorb β2M, via a molecular sieving effect because of its porous structure~     and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and~     prevent the progression of DRA in Japan since 1996, when health insurance coverage and~     reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and~     Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by~     Lixelle® treatment has been shown in several clinical studies.~   "
8051|NCT02952131|"~     Inflammatory Bowel Disease (IBD) is a group of inflammatory conditions of the small bowel~     and colon. Main types include Ulcerative Colitis and Crohn's Disease. Symptoms are often~     difficult to distinguish except for location and nature of changes. IBD complex arises with~     interaction of environmental, genetic factors, immunological responses, and chronic and~     recurring inflammation.~      Many factor appear as contributory, but no single set of issues appear to explain the~     process. Microbiota, intestinal wall granulation or breach, dietary, genetic predisposition~     all appear to factors. Treatment is often reactive or suppressive medications, neither of~     which appears to reverse the disease processes. This study explores the value of a complex~     group of adipose-derived stem/stromal cells (AD-cSVF) in the disease process.~   "
8067|NCT02951923|"~     Bovine colostrum is the milk produced by cows immediately after calving. It contains high~     levels of proteins that improve immune protection and may act to prevent colds. During~     intense training, athletes often have compromised immune function. This may be especially~     true in club-level rugby players who abruptly start high intensity training in the spring in~     preparation for their competitive season. Our study will assess the effects of supplementing~     these players with bovine colostrum during this intense training. Thirty-six players will be~     recruited; half will consume colostrum during the 8 weeks of early-season training and half~     soy protein. The investigators predict the bovine colostrum supplement will improve health~     during the training and increase fitness levels.~   "
8149|NCT02950558|"~     This pilot study will test the hypothesis that prolonged regional peripheral nerve block~     will reduce development of chronic pain in patients undergoing surgery for ankle fracture~     compared to standard of care. Subjects will be followed for one year.~   "
8052|NCT02952118|"~     This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from~     snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard~     diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour).~     Patients with no OSA over the last year will sign an informed consent after receiving~     explanations from authorized physician (Professor Asher Tal). The patient will than undergo~     a sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical,~     Israel) ,an approved device in Israel, USA and many other European countries,, approved for~     use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more~     than 15 events per hour of sleep.~      The study duration with each patient will be 48 hours (two nights); at the first night the~     sleep study will be with PAT device, with snoring recording and without the Forrest epic~     device. In the second night the sleep study will be with PAT device, with snoring recording~     and with the Forrest epic device. The order of the sleep studies (with and without the~     epic device) will be randomly determined by computerized ahead prepared list. The research~     duration for patients that did not have a sleep study over the last year, will take place~     for 3 nights; the sleep study will be performed in order to make sure the patient does not~     suffer from obstructive respiratory disorder during sleep. The sleep studies will take place~     in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at~     home.~      Recordings over the nights with or without the Forrest epic device will be carried out at~     the patient's home, after verification that each patient sleeps alone in his/her room. The~     recording and data processing of snoring will be performed through the application SNORLAB~     on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out~     during two nights (with and without the Forrest Device) with most patients.~      During the examination, respiratory index will be tested such as: obstructive respiratory~     events during sleep, oxygen saturation in blood at rest (measured non-invasively) during~     sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of~     oxygen saturation in blood.~   "
8053|NCT02952105|"~     It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation~     early. At the same time Research findings have identified high-quality CPR with minimum~     interruption is critical to the success of defibrillation therapy. Both the guidelines by~     American Heart Association and the guidelines by European Resuscitation Council emphasize~     the importance of minimizing interruptions in chest compressions, specifically, duration of~     the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of~     VF during chest compression, which has high sensitivity and specificity. And the~     investigators can identify VF and defibrillate earlier.~      The aim of this study is to verify that if Sherlock algorithm of Philips MRx~     monitor/defibrillator can identify shockable rhythms during chest compression accurately.~   "
8054|NCT02952092|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to~     darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.~   "
8055|NCT02952079|"~     The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better~     option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.~   "
8056|NCT02952066|"~     The purpose of this study is to measure the density of a temperature-sensitive protein,~     named TRPV1, in the airway mucosa tissue of both non-asthmatic and moderate to severe~     persistent asthmatic patients. This study may generate information for developing new~     therapeutic strategy.~   "
8057|NCT02952053|"~     The main objective of this study is to assess effects of Dry Needling into Myofascial~     Trigger Point compared Dry Needling into Taut Band point based on the outcomes of~     myotnometric measurement in healthy subjects.~      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the~     soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling~     of the Taut Band of the soleus muscle.~   "
8058|NCT02952040|"~     The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the~     pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.~   "
8059|NCT02952027|"~     Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare~     expenses. The goal of perioperative respiratory therapy is to improve airway clearance,~     increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously~     used to prevent atelectasis and PPCs—implementation of which requires substantial provider~     time and healthcare expenses. However, meta-analyses have demonstrated that the~     effectiveness of ISs is unclear due to poor patient compliance in past studies.~      The goal of this investigation is evaluate the effectiveness of IS on post-operative~     clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance~     can be improved by adding a use-recording patient reminder alarm, and 2) the clinical~     outcomes of the more compliant IS users vs. the less-compliant IS users.~   "
8060|NCT02952014|"~     The purpose of this study is to examine the acute effects of a pre-workout dietary~     supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental~     focus.~   "
8061|NCT02952001|"~     The purpose of this study is to characterize the continued clinical benefit(s) regarding~     safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide~     injectable suspension, for the treatment of macular edema associated with non-infectious~     uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.~   "
8062|NCT02951988|"~     This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams~     (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive~     treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in~     participants with Major Depressive Disorder (MDD).~   "
8063|NCT02951975|"~     This observational study will evaluate the safety, efficacy, characteristics of patients,~     characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as~     treatment for non-infectious uveitis of the posterior segment of the eye in France.~   "
8064|NCT02951962|"~     This is a phase 1, open label, two-cohort, single-sequence, crossover study~   "
8065|NCT02951949|"~     One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk~     actors including clinical features, serum biochemical parameters, single nucleotide~     polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness~     (92 women) and coronary computed tomography (32 women). MANOVA analysis confirmed that both~     age and estradiol level behaved as independent variables associated with IMT. Findings at~     the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen~     stenosis were sporadic and did not allow for establishing association with any of the~     variables assessed.~   "
8066|NCT02951936|"~     Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by~     NI medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived~     parameters.~      Patients fluid balance will be planned according to these parameters and the rate of~     liberation from ventilator and rate of worsening renal function will be measured~   "
8548|NCT02945397|"~     The study compares the effect of a group-based activity with an individual work-out activity~     on work participation.~   "
8068|NCT02951910|"~     Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can~     already be found in several artificial tears recommended to alleviate symptoms of dry eye. A~     recent hyaluronate modification involves zinc-hyaluronate complex formation by adding~     zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular~     structure, which functions as both a mechanical barrier and a biocompatible film on the~     ocular surface. Apart from its beneficial elastoviscous characteristics, previous results~     indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor~     endings underlying pain. Although hyaluronate is widely used in artificial tears to improve~     tear film stability, its effect on ocular surface sensitivity was not evaluated in patients~     with dry eye. The aim of this study is to investigate the characteristics of ocular surface~     sensations and corneal sensitivity in dry eye patients before and after long-term tear~     supplementation with zinc-hyaluronate.~   "
8069|NCT02951897|"~     In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases,~     83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC~     patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone~     surgical treatment, will have a relapse or progression.~      Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or~     lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far,~     CTCs-detection technologies can be divided into epithelial cell adhesion molecule~     (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and~     EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators~     used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung~     Adenocarcinoma cases.~      The investigator aim to explore whether CTCs detection prior to surgery can be contributive~     to the early diagnosis, or may help to predict the prognosis and guide the treatment~     strategy of early stage lung Adenocarcinoma.~   "
8070|NCT02951884|"~     This study will evaluate pain level experienced by patients who have a break of the top of~     their shinbone and have either blood removed from the joint alone or have blood removed and~     medicine injected into the joint.~   "
8071|NCT02951871|"~     Background.Although the life expectancy of patients with FL has recently increased, notably~     since the introduction of rituximab in combination with chemotherapy, little is known~     regarding the precise causes of patients death. Patients and methods'. This study describes~     the different causes of death in FL patients among followed since 2000 at Lyon University~     Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as~     related to lymphoma progression, treatment-related toxicity (including TRM and secondary~     myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.~   "
8072|NCT02951858|"~     The purpose of this research is to improve the ability of primary medical staffs in~     screening and intervention for alcohol, benzodiazepines, and other illicit drug use.~   "
8073|NCT02951845|"~     The purpose of the study is to assess the oral bioavailability of the two tablet~     formulations of JNJ-54416076 relative to the suspension formulation and to investigate the~     effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy~     participants.~   "
8074|NCT02951832|"~     The investigators are going to select the normal child-bearing period women as the study~     subjects and draw their peripheral blood to observe and analyze the change of quantity and~     percentage of lymphocyte subsets along with the change of menstrual cycle.~      Recording their BMI\menstrual history\and childbearing history, the investigators would~     select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged~     30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral~     vein (adding EDTA for anti-coagulation). The investigators are going to perform routine~     examination on the blood samples and detect T\B\NK lymphocyte through flow cytometry (FCM),~     thus calculating the absolute number of every species of lymphocyte. The investigators make~     assessment for the cellular immune function of the women during child-bearing period via~     comparing distinction in percentage and absolute number of every lymphocyte subset among~     reproductive-age women in different ages.~   "
8075|NCT02951819|"~     The purpose of this study is to evaluate complete response plus (+) very good partial~     response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in~     combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in~     previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by~     the International Myeloma Working Group (IMWG) criteria.~   "
8076|NCT02951806|"~     Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids.~     Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in~     postpartum patients and 69% in non-pregnant patients including males and females (1). Some~     researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and~     effective way to reduce the incidence and severity of hypotension during cesarean section~     under spinal anesthesia (2). In this new research I want to investigate the effect of slow~     injection of fentanyl separately, in spinal anesthesia for cesarean section, on the~     incidence of itching In this double blind randomized study two hundred parturient will be~     randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after~     dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds~     All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria~     will be those with allergy to any medications, contraindications to spinal anesthesia, those~     who requested sedation, presence of skin lesions that may cause itching and opioid~     addiction.~      Parturient will be monitored regarding the incidence of itching, hypotension, nausea and~     vomiting. Onset and level of sensory block will also be recorded.~   "
8077|NCT02951494|"~     The AlterG®-anti-gravity treadmill provides lower body weight support which enables~     individuals to exercise without feeling their full body weight. How this body weight support~     influences cardiovascular, respiratory, vascular and metabolic parameters is currently~     unclear. Further, whether body weight support influences the trainability in response to~     moderate continuous exercise is unknown. This investigation has two main goals. First, we~     explore the direct influence of lower body weight support on cardiometabolic parameters~     during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory~     fitness in response to a structured exercise protocol using moderate intensity with and~     without lower body weight support.~   "
8079|NCT02951468|"~     Background Treatment of clavicular non- and malunion is still challenging. Current surgical~     procedures often result in partially frustrating functional outcome along with high-grade~     subjective impairment and increased rates of revision surgery. However, the combination of~     vital bone graft and a biomechanically sufficient fixation system seems to be a promising~     concept of treatment.~      Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years)~     suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All~     patients were surgically treated using an anatomical precontoured locking compression plate~     (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age-~     and sex-specific relative Constant Score.~   "
8080|NCT02951455|"~     The current project seeks to implement the Multiphase Optimization Strategy (MOST) and~     Community Based Participatory Research (CBPR) principles to identify the most efficient,~     scalable, and sustainable combination of Community Wise components. Community Wise is a~     manualized multi-level intervention aimed at reducing health inequalities related to alcohol~     and illicit drug use (AIDU).This 2x2x2x2 factorial design will be fully powered to detect~     change in AIDU in a sample of 528 men with substance use disorders and a history of~     incarceration residing in distressed communities with predominantly Black populations.~     Participants will be randomly assigned to one of sixteen experimental conditions.~   "
8081|NCT02951442|"~     The primary objective is to show that the contribution of Klotho by the renal graft is an~     independent determinant of the evolution of the recipient's central arterial stiffness~     during the first year of renal transplant. The contribution of Klotho by the graft will be~     estimated by: its circulating concentrations assay, its urinary excretion assay, and,~     indirectly, by the circulating concentrations of FGF23. The recipient's central arterial~     stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity,~     noninvasive reference method for measuring aortic stiffness in human.~   "
8082|NCT02951429|"~     This Phase IIb, randomized, placebo-controlled, multicenter, international study will~     evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to~     pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high~     probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone~     with demonstrated tolerability. Participants will be randomized to receive 1 year of~     treatment with either oral sildenafil or matching placebo while continuing to take~     pirfenidone.~   "
8083|NCT02951416|"~     Born out of the European Union 7th Framework Programme funded project European IPF Network~     (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of~     longitudinal data from IPF patients, including control groups of patients with other lung~     diseases. The registry was initiated with the intention of creating a permanent and~     continuously growing record of well defined data on IPF in Europe, in order to increase the~     chances of finding better treatment options for this devastating disease.~      Clinical colleagues who would like to actively participate (both in terms of patient~     recruitment and data analysis) are invited to contact us~     (http://www.pulmonary-fibrosis.net/).~   "
8084|NCT02951403|"~     The study is a prospective case controlled clinical trial. The purpose of the study is to~     investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow~     when compared to conservative treatment.~   "
8085|NCT02951390|"~     Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which~     might occur despite a regular follow-up. Despite low evidence, high-definition technology~     (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch~     syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority~     study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our~     hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under~     expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection~     rate in patients with Lynch syndrome.~   "
8086|NCT02951377|"~     Aim 1: The primary aim of this study is to test the feasibility of Mechanical Diagnosis and~     Treatment (MDT) +/- transforaminal epidural steroid injections (TESI) on pain and disability~     in patients awaiting surgical consult for lumbar radiculopathy secondary to lumbar disc~     herniation, compared to usual care within the current healthcare system in Calgary, Alberta,~     Canada.~      Hypothesis: the investigators hypothesise that centralisers treated with MDT and~     non-centralisers receiving TESIs + MDT will have demonstrate reductions in self-reported~     pain and disability, compared to usual care controls.~      Aim 2: the investigators will also describe the potential impact on healthcare resources by~     tracking surgical rates and self-reported healthcare utilisation during the study period.~      Hypothesis: based on predicted reductions in pain and disability, the investigators~     hypothesise that there will be a trend toward overall less healthcare utilisation (including~     surgery) in the MDT guided group compared to the surgical wait list group.~   "
8087|NCT02951364|"~     The primary objective of this post-marketing surveillance study is to collect and assess~     data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF))~     treatment regimen, per the approved Korea prescribing information for Harvoni, in routine~     clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety~     (MFDS). Patients will be treated as part of routine practice at Korean healthcare centers by~     accredited physicians.~   "
8088|NCT02951351|"~     The specific aims of this study are to compare patient experience with and without a~     proparacaine drop after povidone iodine. To ensure the extra drop does not interfere with~     antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal~     injection before and after the application of the extra eye drop. Patients will be~     randomized to undergo additional topical analgesia during intravitreal injection vs. the~     standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to~     ensure that the additional topical analgesia does not interfere with antisepsis.~   "
8150|NCT02950545|"~     It is a common clinical practice to leave small amounts of astigmatism uncorrected in~     contact lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses~     may experience blur while driving. The purpose of this study is to determine if correcting~     small amounts of astigmatism with contact lenses will improve driving safety.~   "
9143|NCT02937532|"~     The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT)~     with task-oriented balance training (TOBT) is more effective than general health education~     (GHE) together with TOBT in promoting fear of falling and reducing activity avoidance~     behavior.~   "
8089|NCT02951338|"~     It is important for people with stroke to exercise in order to improve their overall~     recovery and general health. However, these individuals are less physically active than~     people without stroke, and they often do not achieve the recommended frequency, intensity or~     duration of exercise. Low levels of physical activity leads to people with stroke becoming~     very unfit, which can result in functional decline and increased difficulty being active. It~     is important to determine how to encourage people with stroke to be more active in the~     long-term. The transition time between the end of rehabilitation and return to the community~     might be an ideal time to address barriers, and to develop positive habits, knowledge and~     abilities for long-term participation in exercise. We developed the PROPEL program that~     combines exercise with self-management strategies during rehabilitation to promote physical~     activity after rehabilitation. Preliminary pilot findings indicate that people who completed~     PROPEL were more physically active after discharge than those who did not. This study aims~     to evaluate the effect of PROPEL on long-term participation in exercise after discharge from~     stroke rehabilitation. This study will take place at 6 different hospitals. Participants~     will either complete a control intervention (group exercise only) or the PROPEL intervention~     (group exercise plus self-management). Participants' adherence to exercise for 6 months~     after the end of the interventions will be evaluated using activity and heart rate monitors~     and physical activity questionnaires. We expect this study will show that a simple~     intervention delivered during rehabilitation will increase participation in exercise after~     rehabilitation. Increased participation in exercise could then lead to improved stroke~     recovery and overall health, and reduced risk of having another stroke.~   "
8090|NCT02951325|"~     Aim and objectives:~      This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in~     patients with high-risk features on histo-pathology after radical surgery for transitional~     cell carcinoma of urinary bladder~   "
8091|NCT02951312|"~     The study assessed the safety and ability of several doses of an orally inhaled medicine~     [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when~     delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive~     Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was~     designed to find the once-a- day GIS dose that produced the highest improvement in lung~     airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a~     placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of~     the same GIS dose were compared between the two nebulizer systems to determine what effect~     the device had on GIS delivery.~   "
8092|NCT02951299|"~     Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially~     common in critically ill patients, in whom the prevalence of acute kidney injury is greater~     than 40% at admission to the intensive care unit if sepsis is present. Therefore,~     alternative strategies are required to confer better or more complete renoprotection for~     those who suffered from AKI.~      There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline~     (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of~     attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We~     thereby design this controlled, non-randomized clinical trial, aiming at investigating the~     potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.~   "
8093|NCT02951286|"~     This prospective clinical study will evaluate the effect of high pull headgear for molar~     intrusion, compared with the control group, in adolescent patients with open bite~     malocclusion.~      The study sample will consist of 24 patients with anterior open bite divided equally in two~     groups. The sample will be collected consecutively from patients attending the Orthodontic~     Department at Damascus university.~      A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will~     be applied for all patients. High pull headgears will be used in the first group, while, in~     the second (control) group, Open Bite Appliances will be used only.~      The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be~     assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post-~     treatment changes for each group will be evaluated.~   "
8094|NCT02951273|"~     General anaesthesia often reduces blood pressure whereby blood flow to the brain and other~     vital organs may become insufficient. Thus, medicine is often administered during~     anaesthesia to maintain blood pressure. However, it is unclear at what level blood pressure~     should be aimed at during anaesthesia.~      Several factors may affect blood flow to the brain during anaesthesia. During surgery on the~     internal organs, a hormone may be released that dilates blood vessels and causes a so-called~     mesenteric traction syndrome characterised by a decrease in blood pressure and flushing.~     This reaction lasts for approximately thirty minutes and is observed in about half of the~     patients who undergo surgery on the stomach and intestines. It is unknown whether a~     mesenteric traction syndrome affects blood flow to the brain. Ventilation is also of~     importance for blood flow to the brain. Thus, blood flow to the brain is reduced by~     hyperventilation and increases if breathing is slower. It is unclear whether the relation~     between blood flow to the brain and ventilation is affected during anaesthesia.~      This study will evaluate how blood flow to the brain is affected by anaesthesia and standard~     treatment of a possible reduction in blood pressure. Further, the study will assess whether~     blood flow to the brain is affected by development of a mesenteric traction syndrome.~     Lastly, the project will evaluate blood flow to the brain during short-term changes in the~     patient's ventilation by adjustments on the ventilator.~      Thirty patients planned for major abdominal surgery will be included in the project. The~     study will take place from the patient's arrival at the operation room and until two hours~     after the start of surgery. Placement of catheters and anaesthesia are according to standard~     care. Blood flow to the brain will be evaluated using ultrasound. Oxygenation of the brain,~     skin and muscle will be evaluated by probes that emit light. Depth of anaesthesia is~     assessed by recording the electrical activity of the brain. Blood pressure is measured by a~     catheter placed in an artery at the wrist and blood samples will be drawn from the catheter.~   "
8095|NCT02951260|"~     The purpose of this study is to evaluate the potential interaction between metformin and~     exercise in order to optimize clinical guidelines for treatment of T2D.~   "
8096|NCT02951247|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be~     conducted on hard of hearing participants to grant quality control prior to product launch.~     The aim of the investigation series is to ensure zero-defect overall performance of the new~     hearing systems as well as maximum benefit for the participant with the devices in~     comparison to previously outstanding Phonak Hearing Systems.~   "
8097|NCT02951234|"~     Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children~     under the age of 5 years old. This trial has been designed as a multi-center, prospective,~     randomized controlled, evaluator-blinded trial with two parallel groups to determine whether~     IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with~     high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.~   "
8098|NCT02951221|"~     The primary objectives of the study are to assess the relative bioavailability of the~     BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation~     (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the~     BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability~     of BIIB074 administered as the DCF following single oral dose administration in healthy~     participants.~   "
8151|NCT02950532|"~     The objective of this investigation is to confirm the results obtained in a pilot study~     showing that certain radiological parameters based on computed tomography (CT) scans seem to~     reliably detect posterior ligament complex (PLC) injury without the need for Magnetic~     Resonance Imaging (MRI)~   "
46841|NCT02443922|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
8099|NCT02951208|"~     Negative symptoms, which include the loss of motivation, social withdrawal and reduced~     emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These~     negative symptoms lead to significant functional impairment and enduring disability in these~     youth. At present, there are no established treatments for negative symptoms. Recent~     evidence from independent studies, however, suggests two promising novel treatment~     approaches for negative symptoms, transcranial direct current stimulation (tDCS), and~     computerized remediation strategies. The primary aim of this study is to evaluate if tDCS~     combined with a virtual reality-based computerized remediation (VR) is effective for~     treating negative symptoms in CHR youth, thereby mitigating the enduring functional~     disability these symptoms cause.~   "
8100|NCT02951195|"~     This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group,~     multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple~     Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with~     cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function~     (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are~     homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR)~     gene (F508del/F508del).~   "
8101|NCT02951182|"~     This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group,~     multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and~     triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects~     with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF~     transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous~     for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to~     TEZ and/or IVA therapy (F508del/MF).~   "
8102|NCT02951169|"~     This study evaluates life quality of patients who were diagnosed with gallbladder benign~     disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will~     establish a database including 20,000 patients. Through observational followup and statistic~     analysis，identifing a model or scale to standardized surgical indication, help surgeons and~     patients determine the best treatment decision.~   "
8103|NCT02951156|"~     Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase~     1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents~     for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).~   "
8104|NCT02951143|"~     Tobacco regulatory policies can have unanticipated consequences; therefore, methods that~     would permit prospective estimates of the effects of potential tobacco regulations are~     necessary for the development of tobacco regulatory science. The goal of this project is to~     experimentally assess how smokers purchase and consume reduced-nicotine cigarettes and how~     this is related to nicotine content and absorption. The proposed projects can directly~     inform tobacco regulation by providing estimates of the real-world effects of novel~     policies.~   "
8105|NCT02951130|"~     Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and~     persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory~     failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to~     conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased~     pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction.~     In patients with CDH, left ventricular dysfunction, either caused by right ventricular~     overload or a relative underdevelopment of the left ventricle, is associated with poor~     prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic~     contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and~     has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during~     the management of CDH although no randomized trials have been performed to test its~     efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database~     (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received~     milrinone. In the recently published VICI trial, 84% of patients with CDH received a~     vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal~     diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of~     this medication in CDH and test its efficacy in improving oxygenation.~   "
8106|NCT02951117|"~     This is an open-label, multicenter clinical trial designed to evaluate the safety and~     potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in~     participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more~     prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A~     and Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.~   "
8107|NCT02951104|"~     Comparison of noninvasive cardiac output monitoring device with Fick and thermodilution~     methods during right heart catheterization in patients with pulmonary hypertension.~   "
8108|NCT02951091|"~     In-depth understanding of molecular characteristics of gastric cancer enabled us to realize~     personalized medicine with targeted agents in gastric cancer treatment.The investigators~     initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted~     therapy based on tumor molecular profiling with standard paclitaxel therapy as second line~     treatment.~   "
8109|NCT02951078|"~     This study is to verify the short-term efficacy and long-term prognosis of thulium laser~     resection compared with conventional transurethral resection of non-muscular invasive~     bladder cancer. Half of participants will receive thulium laser resection of bladder cancer,~     while the other half will receive electrical transurethral resection of bladder cancer.~   "
8110|NCT02951065|"~     This study tests if a bristle-less tooth brush has any measurable effect on gum recession in~     patients who are seen regularly for preventive dental care compared to a regular soft~     tooth-brush.~      Subjects are recruited from patients attending the Western University of Health Sciences~     Dental Center and asked to continue regular preventive dental care while using either the~     test or control brush for a year and using floss and toothpaste supplied by the researchers.~     The exams include measurement of plaque, pockets and gum recession every 3 months, and~     involve photographs and impressions of the teeth and gums to record any changes that occur.~   "
9156|NCT02937363|"~     The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation~     on redox status, physiological and biochemical parameters in G6PD deficient individuals~     after acute exercise.~   "
8111|NCT02951052|"~     The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to~     establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with~     current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors~     (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular~     (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase~     3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group,~     non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are~     stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to~     demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg +~     RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV~     regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be~     randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or~     switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed~     by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week~     52, participants who were randomized to continue their current ART regimen will be given an~     option to switch to CAB LA + RPV LA injections. Those participants would transition to LA~     dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM~     CAB LA + RPV LA injections at Week 56.~   "
8112|NCT02951039|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed~     this non-interventional study to gain insight into the safety (bleeding, liver adverse~     events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban~     use in non-preselected patients with NVAF.~   "
8113|NCT02951026|"~     This long-term extension study is designed to monitor the long-term safety, tolerability,~     and efficacy of treatment of SM04690 or placebo previously injected in the target knee~     joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a~     Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo~     therapy will be administered in this study.~   "
8114|NCT02951013|"~     The hemoglobin concentrations of patients assigned to the restrictive strategy of~     transfusion were maintained in the range of 6.0 to 8.0 g per deciliter, with a transfusion~     given when the hemoglobin concentration fell below 6.0 g per deciliter. Patients assigned to~     the liberal strategy of transfusion, the hemoglobin concentrations were maintained in the~     range of 8.0 to 10.0 g per deciliter, with a threshold for transfusion of 8.0 g per~     deciliter.~      The primary outcome: Death from all causes in the Six months after randomization,~     Perioperative complications: sepsis , Pulmonary complications, Portal vein thrombosis,~     Hepatic artery thrombosis, Adverse event of transfusion.~      Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood~     transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the~     intensive care unit, Lengths of stay in the intensive care unit and the hospital were also~     recorded.~   "
8115|NCT02951000|"~     Influence of the platysma suture on postoperative pain and wound healing.~   "
8116|NCT02950987|"~     This study is evaluating Whole Body MRI as a possible screening tool to diagnose cancer for~     people with LFS and other inherited cancer predisposition syndromes.~   "
8117|NCT02950974|"~     Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose~     of sterofundin solution given to healthy volunteer in the resuscitation manner compared with~     normal saline solution.~   "
8118|NCT02950961|"~     Implementation of Tailored Collaborative Care for Women Veterans (CCWV) is designed to~     enhance primary care-mental health integration for women Veterans, by tailoring services to~     women Veterans' and providers' needs and providing an evidence-based intervention,~     Coordinated Anxiety Learning and Management, to address anxiety and depression in a~     patient-centered approach. CCWV will be implemented in four of the Women's Health~     Practice-Based Research Network sites, with careful attention to local tailoring and~     adaptation to enhance the fit of the care model in varied local contexts.~   "
8119|NCT02950948|"~     The main objective of this study will be to assess the efficacy of natural progesterone at a~     daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the~     ongoing pregnancy rate.~      The secondary objectives will be the rate of endometrial biopsy showing an in phase~     endometrium after 3 months of treatment.~      The length of the luteal phase of the menstrual cycle after treatment will also be assessed~     and compared with the initial duration (from LH peak to onset of menstruation).~   "
8120|NCT02950935|"~     The main objective of this study will be to assess the efficacy of natural progesterone at a~     daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of~     threatened abortion. The secondary objectives will be the efficacy of progesterone in~     reducing both pain and uterine contractions.~   "
8121|NCT02950922|"~     This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults~     and adolescent subjects with mild to moderate atopic dermatitis.~   "
8122|NCT02950909|"~     The primary aim of this study therefore is to investigate the effects on pain and disability~     of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and~     a general exercise program for all neck extensor muscles in patients with chronic neck pain.~     As a secondary aim , the effect of both exercise programs on activation pattern of two neck~     extensor muscles was investigated with electromyography (EMG). The investigators~     hypothesized that both exercise programs would have similar effects on pain alleviation and~     pain related disability, but that the emphasized exercise program for the deep semispinalis~     cervicis would improve its activation more compared to the general exercise program. The~     results of this study will be relevant for designing effective rehabilitation/training~     programs for patients with chronic neck pain.~   "
8177|NCT02950194|"~     The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI~     (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh~     augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively.~     Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire~     and by ultrasound examination.~   "
8178|NCT02950181|"~     This study involves looking at Cerebral oximetry measurements in pediatric and neonatal~     patients who are experiencing a critical illness. Such as Altered mental status, seizures,~     trauma, sepsis, etc.~   "
8123|NCT02950896|"~     Fetal heart rate [FHR] monitoring is used widely to assess the well-being of the baby in the~     delivery period. If it is determined that an urgent cesarean delivery is required because of~     fetal distress, FHR is discontinued once the mother is in the operating room in order to~     allow for surgical site preparation. From this point, there is no real-time monitoring that~     permits assessment of the well-being of the infant. The investigators are evaluating the~     feasibility of intraoperative FHR monitoring using fetal ECG placed on the mother's upper~     abdominal wall and the standard acoustic device routinely used. The investigators will~     compare these to the traditional well-being tests: umbilical arterial blood gas and Apgar~     score.~      The first 15 subjects will be recruited from pregnant women who have scheduled induction of~     labor. The subsequent 40 subjects will be recruited from pregnant women who have scheduled~     cesarean sections.~   "
8124|NCT02950883|"~     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice~     daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT)~     in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to~     6) with cystic fibrosis.~   "
8125|NCT02950870|"~     The purpose of this study is to determinate the AMH levels before and after antiviral~     therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched~     HCV-positive women not undergoing antiviral treatment.~   "
8126|NCT02950857|"~     An open-label study in which 6 patients will receive once-weekly subcutaneous injections of~     EPEG for 4 weeks. Final visit will occur 60 days after study entry~   "
8127|NCT02950844|"~     Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its~     incidence is increasing partly due to the ageing population and it has been referred to as a~     growing epidemic. AF results in irregular contractions of the heart causing unpleasant~     symptoms of palpitations and increasing the risk of stroke, heart failure and death.~     Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF.~     The success rate of these procedures have improved with time due to our better understanding~     of AF, development of new techniques and technology, and greater physician experience.~     However, the success rate of these procedures still only remains around 70%. This is~     contributed to our limited ability to find the areas that drive the AF.~      STAR mapping is a novel mapping system that has been developed with a view of better~     identifying the sites that drive AF, through taking into account the mechanisms of AF that~     have already been demonstrated. Data from this study will be used to refine the~     identification of drivers in the fibrillation left atrium with enormous potential to~     simplify ablation and improve success rates and thereby reducing the need for further~     procedures.~      To better validate this mapping system the investigators also aim to use it in participants~     with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can~     be readily identified with the existing mapping systems used in clinical practice. The~     investigators will demonstrate that the STAR mapping algorithm can effectively map AT.~      To gain further understanding of the changes that occur in the left upper chamber of the~     heart in the context of AF half of the participants with AF will undergo cardiac magnetic~     resonance imaging to assess for the presence of scar. This will enhance our understanding of~     how atrial remodelling promotes AF, which may point to ways of modifying this process and~     preventing AF.~   "
8128|NCT02950831|"~     The purpose of this study is to assess feasibility of using wearable sensors to capture~     objective assessments of patient's activity and sleep quality during the spinal cord~     stimulation (SCS) treatment continuum.~   "
8129|NCT02950818|"~     To evaluate the effectiveness of Take Heart, a behavioral/educational program for adults age~     50+ with heart disease, or with at least two risk factors for heart disease, that helps them~     to better manage their health condition(s). Take Heart is a new version of an evidence-based~     program that has recently been adapted to be suitable for the needs of adults residing in~     Detroit.~   "
8130|NCT02950805|"~     This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in~     patients with Cystic fibrosis (CF) after single-dose administration.~   "
8131|NCT02950792|"~     Current dose escalation regimens with and without chemotherapy have failed to achieve~     improved local control and overall survival over standard of care therapy to date.~     Difficulties with dose escalation have been largely due to dose limiting toxicities of~     surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real~     time, online adaptive planning using magnetic resonance imaging (MRI) could achieve~     significant volume reduction of primary lung disease over the course of therapy, thereby~     reducing dose to normal structures, and providing a mechanism in which to dose escalate~     safely, and more effectively with accurate target delineation.~      The investigators hypothesize that MRI based adaptive planning will provide a novel method~     to dose escalate safely with acceptable organ at risk doses. In addition, further~     improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality~     of target-tissue coverage will be achieved through the use of 4D real-time tracking which is~     derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography~     Simulator (CTsim) with advanced non-rigid image-registration tools.~   "
8132|NCT02950779|"~     Inflammatory bowel disease (IBD) is a chronic disease, which causes inflammation of the gut.~     People with this disease are often poorly nourished. Problems caused by poor nutrition such~     as poor wound healing can be reduced if it is recognised and treated early.~      When people with IBD attend outpatients clinic with their IBD specialist they are weighed~     and their BMI calculated to indicate if they are poorly nourished. Weight and BMI may not~     always provide a good assessment of how well nourished a person is because it does not~     describe the amount of muscle in the body in proportion to fat. A person with a low or~     decreasing amount of muscle but a normal or high BMI is at risk of nutritional problems.~     Measuring the amount of muscle someone with IBD has in routine practice poses a challenge to~     clinicians due to time constraints. One-way of measuring the amount of muscle a person has~     is to measure their muscle strength. This can be measured by recording the strength of a~     person's handgrip. Handgrip strength can be measured using a hand-held device called a~     dynamometer.~      This study aims to test whether it is possible to measure the handgrip strength of people~     with IBD attending outpatient's clinic. It also aims to test how the measure obtained~     compares with other methods of assessing whether someone is malnourished and their health.~     People with a diagnosis of IBD who are aged 18 or older and who are scheduled to attend IBD~     outpatients clinic in one hospital will be asked to take part in the study. Their handgrip~     strength will be measured each time they attend clinic over a nine-month period in addition~     to other information about their health and nutritional state. This study forms part of a~     Masters in Research being undertaken with The University of Southampton.~   "
8133|NCT02950766|"~     This research study is evaluating a new type of Kidney Cancer vaccine called Personalized~     NeoAntigen Cancer Vaccineas a possible treatment for Kidney Cancer.~      The following intervention will be involved in this study:~        -  Personalized Neoantigen Vaccine~        -  Poly-ICLC (Hiltonol)~        -  Ipilimumab~   "
8135|NCT02950740|"~     Food intake pattern and lifestyle are associated with the nutritional status and intestinal~     microbiota composition, and such factors are important for the proper growth and development~     during early childhood, as well as for the health throughout life. This cross-sectional and~     multicenter study will include a total of 200 children aged between 1-3 years, enrolled in~     early childhood public schools from different regions of Brazil (Santo André, Uberaba, Porto~     Alegre and Natal). Data on birth and gestational history will be collected in a form.~     Nutritional status will be assessed by determining the weight and height, with subsequent~     calculations and classification of nutritional indices. A single blood sample will be~     collected to investigate the blood levels of vitamins A and D, iron, calcium, alkaline~     phosphatase and zinc, and feces will be collected for intestinal microbiota analysis. Food~     intake will be assessed by direct weighing of food in 2 non-consecutive days. Considering~     the importance of a well-balanced diet and its effects on the child's growth, development~     and intestinal colonization, this study purpose is to investigate potential associations~     among food intake, nutritional status and intestinal microbiota of early childhood infants~     from four regions of Brazil.~   "
8136|NCT02950727|"~     In this current study a comparison between 3 positional screws versus the adjustable plating~     system in conjunction with 2 positional screws. The patients will be selected to have~     retrognathic mandible requiring advancement. Hypothetically the advantage of the adjustable~     plating system will be compared with the three positional screws. In theory, the~     investigators will be using the inherent advantage of the intraoperative flexibility of the~     adjustable plating system in verifying the position of the proximal segment (condylar~     segment), hence eliminating the immediate postoperative relapse that is reported with using~     three positional screws. This will be evaluated both clinically and cephalometrically.~   "
8137|NCT02950714|"~     This study asks whether persons with lupus will use and uptake the information and services~     of the web-based lupus interactive navigator (LIN) on a regular basis and whether this~     uptake will be associated with better self-management, improved coping, higher sense of~     control over their life, and overall improved health.~      Systemic lupus erythematosus is an incurable chronic multi-organ inflammatory disease that~     affects preferentially young women. Unmet needs include a 15% excess in mortality, high~     morbidity and poor work outcomes. Despite prevalence of 1:2000, lupus is mostly unknown from~     the public and access to specialized care remains limited. Therefore, persons with lupus and~     their caregivers have difficulty finding high quality information relevant to their lupus~     journey.~      The LIN research team consists of a lupus clinical expert and researcher, a clinical~     psychologist and behavioral researcher, and a health information specialist. This team,~     funded by the Canadian Institutes of Health Research (CIHR), was responsible for the~     development of the LIN, a web-based navigator designed to promote self-care. The LIN is~     completed and the team will work with several stakeholders for dissemination: Lupus Canada,~     the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS), the~     Arthritis Alliance of Canada, and lupus patient advisers. CaNIOS centres will be to~     randomized to immediate access to the LIN (LIN_NOW group) or usual care with crossover at 3~     months (LIN_WAIT group). At baseline, all patients meeting entry criteria will be contacted,~     and asked to complete online questionnaires. At three months, a second online assessment~     will be performed before crossing over those from the centres randomized to usual care in~     order to now provide them with an access to the LIN. A final assessment will be performed at~     six months. Comparisons of baseline versus LIN exposure over three months will be performed~     in all patients at the end of the study; comparison of LIN use versus usual care will be~     done at three months; and retention of use at six months after LIN exposure will be~     documented in the first group randomized to LIN. The main outcome will be the Patient~     Activation Measure, a valid tool that measures the level of patient engagement. Secondary~     outcomes will include variables describing access and use of the LIN captured by the LIN~     server, coping, self-efficacy, and global health status.~   "
8138|NCT02950701|"~     The purpose of this study is to collect non-invasive opportunity sample data in suspected or~     known cases of carbon monoxide poisoning.~   "
8139|NCT02950688|"~     The purpose of this study is to evaluate the immune response produced by a seasonal live~     attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will~     be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical~     response, and viral shedding after exposure to the wild-type A/California/2009-like~     influenza challenge virus.~   "
8140|NCT02950675|"~     The relationship of body function, participation and quality of life in patients with burn:~     A longitudinal study~   "
8141|NCT02950662|"~     The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in~     terms of retention and patient satisfaction~   "
8142|NCT02950649|"~     This project is designed to assess the impact of pre-operative use of non-invasive~     hemodynamic monitoring technologies on improving peri-operative and post-operative care of~     moderate to high-risk surgical patients with poor functional status by improving the~     detection of reduced cardiovascular function.~   "
8143|NCT02950636|"~     The purpose of this study is to learn if a structured yoga program can reduce anxiety,~     improve depression, and improve quality of life in patients with medication resistant~     epilepsy (MRE).~   "
8144|NCT02950623|"~     Cross over design the investigator divide participants to two groups group (A) will receive~     rapid heat cured denture base material and group (b) will receive the acrylic denture~     modified by titanium dioxide nanoparticles and after washout period alternatively group (a)~     will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b)~     will receive rapid heat cured denture base material the investigator will take swaps from~     dentures to count the anaerobic bacteria.~   "
8145|NCT02950610|"~     The purpose of this is to analyse human exhaled breath by means of a device called~     electronic nose(eNose) in patients with non-alcoholic fatty liver disease (NAFLD) as a way~     to non-invasive assessment of liver disease.This device is medically adapted and clinically~     validated in patients with lung conditions.~   "
8146|NCT02950597|"~     Study Details What is the study design? (eg, randomized, double-blind) Observational~     Prospective Study What are the overall objectives of the study? This project is designed to~     assess the feasibility of using a non-invasive hemodynamic monitoring device in heart~     failure outpatient clinics. There will be no alteration to patient management for this~     study. Rather this study seeks to assess the utility of the device in this patient care~     setting by surveying the clinicians involved.~      What is the primary endpoint? For this phase I study, the primary endpoint will be the heart~     clinician's survey results.~      What is/are the secondary endpoint(s)? Secondary markers will include: patient survey~     results, heart failure classification, renal function, blood pressure, cardiac function~     tests, and pulmonary function tests.~      How your research will contribute to the advancement of scientific knowledge? ☒This study~     will confirm/strengthen existing knowledge.~        -  This study will test a completely novel hypothesis.~        -  This study will explore novel endpoints. ☐Other [please describe]:~   "
8147|NCT02950584|"~     Measurement of surface roughness of tow different material of denture base to find out which~     material is more hygienic by decreasing the amount of bacterial accumulation.~   "
8152|NCT02950519|"~     There is no accepted standard for the frequency of monitoring endotracheal tube cuff~     pressures (ETCP). We plan on comparing two strategies for monitoring ETCP in mechanically~     ventilated patients. The two strategies will be the currently employed practice protocol as~     outlined in the Respiratory Therapy Protocol at Barnes-Jewish Hospital (BJH) which requires~     ETCP to be assessed immediately after the endotracheal tube is placed and after any~     manipulation of the endotracheal tube to include repositioning, manipulation of the cuff~     volume, or presence of an audible leak. We will compare this current practice to a more~     intensive monitoring of ETCP which is employed at some hospitals and includes the same~     elements as noted in the current practice plus monitoring ETCP every work shift (every 8~     hours or three times per day).~   "
8153|NCT02950506|"~     The purpose of this study is to investigate whether tDCS enhances the effect of cognitive~     remediation therapy on cognition and functional outcome in patients with epilepsy. There has~     been evidence that working memory performance is enhanced in healthy subjects. Acute tDCS~     studies have found improvements in working memory performance in subjects with other~     neurological diseases. To date, there have been no published studies examining whether can~     enhance learning during multi-session cognitive remediation over 2 weeks in subjects with~     epilepsy. This study could have potential application as a non-invasive clinical~     intervention for interictal dysfunction in epilepsy.~   "
8154|NCT02950493|"~     Use of Reactivated DEFINITY® in Patients Undergoing Stress Echo Purpose of the study: Each~     patient undergoing a stress echocardiogram uses a full vial of DEFINITY® contrast agent.~     During infusion, this often condenses back to its liquid phase due to manual pressure~     applied in the syringe. At this point, it is not optimal to be used at current ultrasound~     settings for stress echocardiography. This research project will test whether this condensed~     DEFINITY® can be reactivated by ultrasound using the same transducer used to image the~     patient.~      Eligibility: Same criteria as required for stress echo procedure. Interventions and~     Evaluations: Inject condensed DEFINITY® at end of stress test Follow Up: The patient would~     be observed by echo lab staff for half an hour following completion of the stress test.~     There would be no longitudinal follow up.~   "
8155|NCT02950480|"~     A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be~     undergoing mastectomy with immediate tissue-expander reconstruction to determine whether~     treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular~     contracture.~   "
8156|NCT02950467|"~     The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is~     a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).~   "
8157|NCT02950454|"~     This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high~     intensity interval training in people with progressive multiple sclerosis. A control group~     of people with progressive multiple sclerosis will undergo continuous moderate intensity~     exercise, twice weekly for 8 weeks.~   "
8158|NCT02950441|"~     This study is designed to assess the physiological consequences of elevating Nicotinamide~     Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in~     skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.~   "
8159|NCT02950428|"~     The purpose of this investigation is to collect data pertaining to the safety and~     performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo~     (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with~     severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement~     (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via~     minimally-invasive transapical implantation in a well-defined population.~   "
8160|NCT02950415|"~     Children undergoing anesthesia are often very frightened by the experience. This can lead to~     bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can~     influence their future experiences with anesthesia and surgery. The investigators believe~     the presence of a parent via video might work better as parental fear is not transferred to~     the child. The investigators also believe that parents who are coached on how to assist~     their child during anesthesia will have a better impact. As such the investigators are~     carrying out this study to assess whether parents who are coached and are present in either~     video or physical form will be more effective in reducing anxiety at induction of~     anesthesia.~   "
8161|NCT02950402|"~     This study evaluates whether the consumption of California dried plums can be beneficial to~     your health. Previous studies using dried plums have shown beneficial effects on bone and~     cardiovascular health. In addition the investigators hope to learn how dried plums might~     change your bowel habits, and if the carbohydrates in the plums are fermented in your~     digestive tract.~   "
8162|NCT02950389|"~     Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact~     with B lymphocyte membranes leading to the activation of transmembrane signaling. The~     ensuing impairment of neutrophil function can contribute to the chronic inflammation state~     of uremic patients, and the increased risk of bacterial infections or vascular~     calcifications. The aim of this crossover observational study was to assess the difference~     in free light chain removal by three different hemodialysis filters in patients not affected~     by multiple myeloma.~      Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane~     Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7~     High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The~     patients were randomized into two groups of treatment lasting six weeks each. The dialysis~     sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and~     240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive~     protein (CRP) and albumin were checked.~   "
8163|NCT02950376|"~     The purpose of this research is to develop an objective assessment based on the virtual~     reality techniques which is used for evaluate addiction severity.~   "
8164|NCT02950363|"~     The purpose of this study is to determine whether use of a suite of smart phone enabled~     mobile health devices can reduce burnout in medical trainees. Such applications can then be~     used in more general populations with the same goal in mind.~   "
8586|NCT02944825|"~     This study will be a single-institutional randomized, single-blinded prospectively~     controlled clinical trial of a single dose of Ciprofloxicin 500mg antibiotic tablet as~     prophylaxis at the time of office flexible cystoscopy with ureteral stent removal. The~     control group will be no prophylaxis oral antibiotics.~   "
8165|NCT02950350|"~     Cervical cancer is the most common reproductive malignancy in developing country. Due to~     local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO~     IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional~     treatment nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis~     high ,and the 5-year survival rate is less than 50%. Therefore, it needs to explore a new~     strategy for improving the prognosis of advanced cervical cancer.~      The prognosis of cervical cancer is closely related to its stages ,while the current FIGO~     clinical stage is too subjective , for example different gynecologic oncologists may give~     different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly~     used as a referrence for clinical staging, but the sensitivity and specificity are not~     satisfied. In addition, lymph node metastasis significantly impacts the prognosis of~     cervical cancer . However, the lymph node invasion is not in current staging criteria.~      Precision treatment after surgical staging is recommended by NCCN recently .Surgical staging~     in patients with advancedcervical cancer is safe and does not delay primary RCTX in few~     randomized study.Whether overall survival benefit the long-term clinical follow-up surgical~     staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size~     and increase the operability , which has been conformed in locally advanced cervical cancer.~     Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition~     via surgical staging .~      Based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer ,~     which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel~     blocking and ovarian transportation, in order to perform individualized postoperative RCTX,~     reduce tumor load , preserve ovarian function and improve life quality.~   "
8166|NCT02950337|"~     Lung cancer is the leading cause of cancer death in both men and women in the United States.~     In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and~     bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network~     (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC)~     is lobectomy with lymph node dissection. Historically, medically inoperable early-stage~     NSCLC patients have been offered definitive external beam radiotherapy (EBRT) as primary~     management but, overall, studies have consistently shown poor patient outcomes. Stereotactic~     body radiation therapy (SBRT) is a technique which delivers very high doses of radiation per~     fraction over one to five fractions to precisely defined volumes with steep dose gradients.~     SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the~     medically inoperable patient.~   "
8167|NCT02950324|"~     The purpose of this study is to evaluate the effect of a multimodal pre-operative~     prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise~     performance and insulin resistance prior to resection for oesophago-gastric cancer.~   "
8168|NCT02950311|"~     This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3~     years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider~     at a Duke- affiliated otolaryngology clinic.~   "
8169|NCT02950298|"~     The primary purpose of this study is to:~        -  Document the developmental outcomes of individuals with Pompe disease treated with~          long-term enzyme-replacement therapy (ERT) through school-age (ages 6-18) using~          measures of cognitive functioning, academic skills, and speech and language abilities.~        -  Investigate possible cognitive processing speed weaknesses using BrainBaseline~          neurocognitive assessment software.~        -  Investigate the relationship between behavior and other developmental factors including~          speech and language ability and cognitive ability.~        -  Explore if the use of selected iPad applications may help strengthen cognitive~          processing speed in children with Pompe disease~   "
8170|NCT02950285|"~     The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by~     preventing stroke. The investigators propose to implement an automated algorithm using~     electronic medical record (EMR) data to alert physicians in a large primary care practice~     network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated~     stroke risk that are not taking an anticoagulant for stroke prevention. The investigators~     hypothesize that interventions to notify physicians of such individuals may prompt~     reassessment for the need for anticoagulation, and thereby increase guideline-indicated~     anticoagulation rates. Additionally, in a survey component, physicians will characterize~     reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.~   "
8171|NCT02950272|"~     The CARD study is a observational study which includes Chinese adolescents with diabetes~     aged 18-30. The study aims to explore the status of disease treatment, self-management, the~     relationship between disease treatment and disease outcome in Chinese adolescents with~     diabetes.~   "
8172|NCT02950259|"~     The goal of this study is assess the safety and tolerability of the IRX-2 regimen in~     patients with early stage breast cancer (ESBC).~   "
8173|NCT02950246|"~     Implementation of perineural catheters may lead to infection by catheter colonization.~     Catheters may be colonized by the bacteria present on the skin. This is most often commensal~     organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral~     nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often~     silent because in the same study only 3% of patients had signs of local inflammation and one~     psoas abscess was observed (0.07%). The germs are most often coagulase negative~     staphylococci (61%) and gram negative bacillus (21.6%).~   "
8174|NCT02950233|"~     The objective of the PAIN-STOP trial is to assess the feasibility of a larger randomized~     controlled trial (RCT) evaluating NMDA antagonists and IV steroids, as compared to placebo,~     in decreasing the chances of clinically significant persistent post-surgical pain (PPSP)~     after video assisted thoracoscopic surgeries (VATS). This is a multi-centre randomized,~     controlled clinical trial with a 2 x 2 factorial design. The pilot phase of the trial will~     recruit 48 patients and follow them for 3 months. Patients will be randomized to one of four~     groups: 1) NMDA active + Steroid placebo; 2) Steroid active + NMDA placebo; 3) NMDA active +~     Steroid active; 4) NMDA placebo + Steroid placebo.~   "
8175|NCT02950220|"~     This phase I/Ib trial studies the side effects and best dose of ibrutinib when given~     together with pembrolizumab and to see how well they work in treating patients with~     non-Hodgkin lymphoma that has come back or does not respond to treatment. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow~     and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Given pembrolizumab and ibrutinib may work better in treating~     patients with non-Hodgkin lymphoma.~   "
8176|NCT02950207|"~     Mono-centric, observational, prospective study, designed for pts with diagnosis of~     hormone-positive breast cancer to evaluate the correlation between the response to hormonal~     treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of~     patients~   "
8179|NCT02950168|"~     Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic~     procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for~     short periods of NOAC interruption without heparin bridging. There is only minimal~     information on the peri-procedural usage pattern of edoxaban and the related outcome data~     currently available. Therefore, further real-world clinical data on the peri-procedural~     usage pattern of edoxaban within any diagnostic or interventional procedure in patients with~     non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in~     this registry.~   "
8180|NCT02950155|"~     A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and~     efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis~     (MG).~   "
8181|NCT02950142|"~     Cluster randomised controlled trial to evaluate what the effect is of evidence-based order~     sets aimed at five indications on the appropriateness of laboratory test ordering in primary~     care.~   "
8182|NCT02950129|"~     The subjects will undergo a specific physical exam of tests reported to be diagnostic of~     sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ that which~     is being performed as part of their normal medical care. Routine care involves use of any~     number of these tests, but doesn't routinely include assessment of all 6 tests in all~     patient's treatment. The subject will fill out a Visual Analog Scale for pain and a pain~     drawing prior to and after the injection.~      The tests will be repeated after the injection.~      The investigators propose to investigate a cluster of tests proposed by Laslett as well as~     compare the results of the ASLR and the Gillet Test both before and after SIJ injection to~     determine the validity of these tests in a low back patients presenting for injections~     thought to be from the sacroiliac joint. The secondary purpose would be the development of a~     clinical predictor rule to determine examination characteristics of patients who may benefit~     from intraarticular injections of the SIJ.~   "
8183|NCT02950116|"~     Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and~     thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma,~     bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while~     asthma is mostly characterized by obstruction due to bronchoconstriction of the airways,~     obstruction in bronchiectasis and CF originates primarily from mucus retention due to~     abnormal airway clearance mechanisms.~      The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector~     of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is~     required for this test makes it very convenient for use in any age category.~      Research on LCI described it as a reliable indicator of obstructive lung disease in~     pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early~     lung disease in asthma children is less clearly demonstrated. No data were found on LCI~     calculated from the N2-MBW-test in children with bronchiectasis.~   "
8184|NCT02950103|"~     Synthetic phosphoethanolamine is a primary amine which has a critical role in the~     biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer~     activity.~   "
8185|NCT02950090|"~     MobilWise, a worksite physical activity intervention for employees at high risk for knee~     osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a~     collaborating worksite to determine if remotely- coached physical activity counseling can~     increase and sustain physical activity in this population. Knee osteoarthritis is a major~     public health problem and a leading cause of disability and work absenteeism/presenteeism in~     the US workforce. The overarching goal of this program is to develop and disseminate an~     affordable, efficient, efficacious physical activity intervention to large groups of~     employees at risk for knee OA. The Mobil Wise intervention is administered by health~     professionals, who will use data transmitted from an affordable accelerometer-based personal~     monitor (Fitbit Flex) via customized remote coach interface to 1) allow the remote coach to~     view and collect physical activity data generated by the personal monitor, and 2) use that~     data to formulate and provide tailored behavioral support, using motivational interviewing.~     This project has the potential to have a tremendous impact on improving symptoms and quality~     of life of persons with chronic knee pain and decreasing the functional limitation, work~     absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.~   "
8186|NCT02950077|"~     The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction~     (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune~     hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction~     disorders and other psychiatric disorders. There has been no study evaluating or showing the~     benefit of the use of MBSR in autoimmune liver disease. With published data showing the~     evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized~     that such an intervention such as MBSR may have therapeutic effect in patients with~     autoimmune liver disease.~   "
8187|NCT02950064|"~     This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel~     platinum product, in patients with advanced solid tumors and BRCA or other DNA repair~     mutation. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation)~     and Part 2 (Expansion). The purpose of this study is to evaluate the safety,~     pharmacokinetics and the anti-cancer activity of BTP-114.~   "
8188|NCT02950051|"~     The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline~     treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by~     combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab,~     Obinutuzumab), which may induce extremely long lasting remissions.~   "
8189|NCT02950038|"~     The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then~     in combination with Opdivo (nivolumab) can control NSCLC in patients who have received~     previous chemotherapy treatment.~   "
8203|NCT02949856|"~     This study evaluates difference of the endotracheal tube cuff pressure between a tapered-~     versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.~      Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and~     cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in~     the supine neutral position and is measured after the change to the neck extension.~   "
9215|NCT02936596|"~     Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome~     induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents~   "
8190|NCT02950025|"~     In light of this new technology and preliminary findings of low toxicity of online,~     adaptive, magnetic resonance (M)-guided stereotactic radiation on a single arm prospective~     study, the investigators propose to compare this technique to online MR-guided stereotactic~     body radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment~     times for patients and comprises an increased burden on technical and clinical staff.~     Although preliminary trial results are encouraging, it remains unclear if the dosimetric~     benefits of online-adaptive planning studies will translate to measurable improvements in~     clinical outcomes that merit its routine use. In our preliminary study, plan adaptation was~     most often required when tumors were adjacent to the gastrointestinal tract (the esophagus~     to the sigmoid colon), as those structures were most commonly the dose-limiting structures~     and were noted to change in location on a day-to-day basis. For these reasons, abdominal~     disease sites have historically highlighted the limitations of SBRT. Specifically, the~     investigators will enroll patients with oligometastatic or unresectable primary disease of~     the non-liver abdomen to a randomized, prospective trial.~      Patients will be randomized to one of two treatment arms, in which they will receive either~     online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will~     undergo MRI simulation and MRI treatment localization with online MR monitoring and/or~     gating. All patients will be treated in five fractions over one to two weeks. By adhering to~     strict normal tissue constraints, the investigators expect toxicity to be within the current~     standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients~     who undergo adaptation based on daily anatomic changes.~   "
8191|NCT02950012|"~     The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis~     MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in~     otherwise healthy adults.~   "
8192|NCT02949999|"~     The study is a single-centre, double-blind, placebo controlled, randomized, ascending~     multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic~     profiles of voclosporin.~   "
8193|NCT02949986|"~     There are many exercise approaches that have demonstrated effectiveness in reducing falls~     and fall risk in community-dwelling older adults. The Otago Exercise Program is one such~     program. The Otago Exercise Program has been tested in four randomized controlled trials and~     one controlled multi-center trial and was found to reduce falls in older men and women. The~     focus of the Otago Exercise Program is on improving strength and balance with a home-based~     balance exercise program. The goal of the current study is to evaluate whether a~     self-administered, tablet-based version of the Otago fall prevention program is both~     feasible and effective for reducing fall risk and improving balance in community-dwelling~     older adults.~   "
8194|NCT02949973|"~     An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict~     clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg BID in~     combination with standard of care in patients with active lupus nephritis~   "
8195|NCT02949960|"~     The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared~     to vehicle control following 28 days of twice-daily topical application to selected target~     lesions in male and female patients with mild to moderate atopic dermatitis (AD).~   "
8196|NCT02949947|"~     The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose)~     with an iron supplement to learn which may be more effective in improving red blood cell~     counts in patients who have iron-deficiency anemia (a low red blood cell count) because of a~     gastrointestinal stromal tumor (GIST) and/or systemic therapy.~      The safety of ferric carboxymaltose will also be studied.~   "
8197|NCT02949934|"~     The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT)~     inhibitor tolcapone, relative to placebo, reduces alcohol drinking and alcohol cue-elicited~     brain activation and increases brain activation associated with cognitive control as a~     function of a participant's genotype at a polymorphism in the COMT gene.~   "
8198|NCT02949921|"~     The objective of this study is to provide a preliminary assessment of the radiographic~     appearance of Radiesse material that has been injected into the dorsum of the hands.~   "
8199|NCT02949908|"~     This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm~     study to measure treatment satisfaction of relapsing remitting MS (RRMS) subjects on Rebif~     after discontinuing initial first-line treatment.This study is a regional study with 3~     participating countries: Belgium, the Netherlands and Switzerland~   "
8200|NCT02949895|"~     A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung~     cancer~   "
8201|NCT02949882|"~     There is a relative high prevalence of constipation and antibiotic-associated diarrhoea~     (AAD) in the elderly residents of nursing homes, mainly due to high antibiotic and~     medication usage. Constipation and diarrhoea causes a substantial burden on lives of the~     frail elderly and significantly reduces the quality of life (QoL). In addition, these~     circumstances lead to a higher workload for healthcare workers and treatment of constipation~     and diarrhoea increase costs in healthcare. There are indications that the gastrointestinal~     microbiome is altered in conditions, such as constipation and AAD. Research indicates that~     probiotics show potential in the treatment of constipation, AAD and infectious diarrhoea.~     Probiotics can restore the aberrant gastrointestinal microbiome and thereby possibly~     treat/prevent constipation and diarrhoea in the frail elderly population. To illustrate, a~     previous pilot study of probiotic administration in elderly residents of a nursing home~     demonstrated a reduced prevalence of constipation and diarrhoea stool types and a higher~     prevalence of ideal stool types during the intervention compared to the baseline period.~     These promising results demand for a confirmatory study in this population.~   "
8202|NCT02949869|"~     The reported rate of unsuccessful traditional LP in children (defined as the inability to~     obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many~     factors affect LP success including provider experience. CSF is obtained by puncturing the~     subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and~     many have hypothesized that the width of this space may predict success. Anecdotally,~     trainees and those with less experience, tend to perform the LP too low (caudally), where~     the subarachnoid space tapers, or too laterally (off the midline) resulting in higher~     failure rates. The investigators seek to determine if planned LP insertion sites vary~     between training and attendings, and if so, could the decreased success be explained by~     smaller subarachnoid spaces.~   "
8206|NCT02949817|"~     This study was designed to establish the clinical evidence for effect of video-game based~     rehabilitation therapy system using IMU sensors as a game interface, newly-developed in~     Korea, on upper limb function of children with cerebral palsy. First, the investigators~     would compare the effect of video-game based rehabilitation therapy to conventional~     occupational therapy.~   "
8207|NCT02949804|"~     Almost everyone is aware these days is aware about the risk of smoking. Still many people~     start this habit specially in early life and during college year. We aim to investigate in~     this study if there is a drive to smoke in people with vasovagal tendency to improve their~     symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness,~     smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation~     between smoking and a positive tilt table test which is indicative of vasovagal tendency. By~     collecting the information regarding smoking habit and vasovagal symptoms analysis can be~     done to see if there is correlation between these two factors~   "
8208|NCT02949791|"~     Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a~     promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the~     pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as~     the best pharmacologic endpoint to assure the efficacy of HIPEC.~      The primary endpoints of the present phase II randomized study are to test whether the~     increased intra abdominal pressure (IAP) during HIPEC could:~        -  enhance the penetration of cisplatin into the residual neoplastic and normal tissues;~        -  elicit changes on pharmacokinetic advantage of cisplatin.~      Secondary endpoints are to evaluate the:~        -  impact of high IAP on intraoperatory hemodynamic and respiratory parameters;~        -  impact on short-term surgical outcomes (in hospital stay, morbidity, mortality).~      Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to~     complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will~     be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be~     randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be~     measured using bladder catheter. High IAP will be obtained increasing the volume of~     perfusate.~      Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The~     randomized groups will be stratified according to tumor type.~   "
8209|NCT02949778|"~     Double blinded, randomized, controlled, phase IV intervention trial. Both groups will~     receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention~     group, and sterile sodium chloride in the control group. The aim of study is to investigate~     the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.~   "
8210|NCT02949765|"~     Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of~     patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good~     compliance and clinical response to gluten-free diet. These patients are usually~     premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not~     balanced.~      The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not~     tolerated, and a dietary approach through a iron-rich diet in this subset of patients.~   "
8211|NCT02949752|"~     This is an open label study to prospectively evaluate the effect of adjunct use of~     Aripiprazole, as an agent to improve metabolic profile and induce weight loss in patients~     established on atypical antipsychotics (Olanzapine, Clozapine and Risperidone).~   "
8212|NCT02949739|"~     the investigators general goal is to identify approaches to risk stratification and health~     promotion through lifestyle modification that are acceptable, effective and efficient for~     prevention of T2D in South Asian communities from diverse settings.~   "
8213|NCT02949726|"~     The goal of this study is to find out which immune molecules, cells, and genes are involved~     in the development of lymphedema (LE), so that medicines that target them can be considered~     for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease~     that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly~     chemotherapy in genetically susceptible patients.~   "
8214|NCT02949713|"~     The primary aim of this study is to find out whether it is feasible to conduct a larger~     study looking at the effect of mobile phone text messaging added to motivational~     interviewing on number of women living with HIV infection reporting exclusive or any~     breastfeeding six months post-delivery.~      Secondary aim: In HIV-infected women initiating breastfeeding after giving birth, does~     interactive weekly mobile phone text messaging plus motivational interviewing versus usual~     care, improve self-reported adherence to exclusive or any breastfeeding 6 months~     post-delivery~   "
8215|NCT02949700|"~     The purpose of this research is to see whether metformin can improve the response rate in~     patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral~     cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the~     effects, good and bad, of metformin therapy for this disease. Researchers will also analyze~     tumor and blood samples from study patients to test and understand the characteristics of~     tumors which respond to metformin.~   "
8216|NCT02949687|"~     Surgical Treatment in Diabetic Patients With Grade 1 Obesity~   "
8217|NCT02949674|"~     Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In~     Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures~     associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber~     classification system divides ankle fractures in three types according to the anatomy of~     lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in~     conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and~     internal fixation. However, it's been reported that even with successful reduction~     surgically great results are not always achieved. Local wound infiltration blocks the pain~     in its origin, surgical site by itself, without alter motor function. Practically without~     presenting adverse events with this method. it´s accurate for ambulatory surgery.~      Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with~     ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction~     and internal fixation.~      Method: Two groups with ankle fractures which will be informed and the patients will sign~     informed consent, after that the patients will be assign to a group (Ropivacaine or~     bupivacaine). The patient will be prepared for surgical treatment according to his doctor.~     It will be applied traditional anesthesia. It will be applied before beginning surgery in~     bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting~     surgery. After that the patient will have the traditional dose of analgesic treatment.The~     group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group~     will register data and will make statistic analysis. It will be elaborated the conclusion an~     elaboration of a report.~      Resources: The group counts with human resources of the group of investigators. The hospital~     has in emergency department almost three patients with ankle fractures each day which~     require surgical treatment. The hospital has x ray service to valuate the ankle fracture and~     with computer system to analyze it. The hospital has the software for statistical analysis.~      Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment~     of ankle fractures. Investigators have the support of pain medicine group in hospital and~     with anesthesia coordinators. Investigators have a group of orthopedic residents which will~     be encharged of ilfiltration wound site.~      Time: September 2016 to February 2017.~   "
8218|NCT02949661|"~     Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients~     with tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the~     common indication for (TRR).The immediate postoperative period can be anxiety provoking for~     some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain~     which inadequately treated.~      Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia~     technique for its feasibility and efficacy. The use of regional anesthesia in combination~     with general anesthesia may lighten the level of general anesthesia required , provide~     prolonged postoperative analgesia and reduce the requirements for opioid analgesics~      Local anesthetic infiltration into the surgical incision can relieve pain at the wound site~     after surgery, as part of multimodal analgesic approach.~      Levobupivacaine, is S-enantiomer of bupivacaine, has strongly emerged as a safer~     alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be~     equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically,~     levobupivacaine has been observed to be well tolerated in regional anesthesia techniques~     both after bolus administration and continuous post-operative infusion.~   "
8219|NCT02949648|"~     A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive~     evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in~     Hong Kong.~   "
8220|NCT02949635|"~     Three events can be considered of major importance for patients after a hospitalization in~     an AGU: death, hospital readmission, and institutionalization. Current published data do not~     allow the clinician to simultaneously estimate the risk of hospital readmission,~     institutionalization and death of an older patient according to his/her characteristics and~     various complications that occurred during the hospitalization. However, clinicians often~     need to estimate these risks at hospital discharge to adapt their therapeutic choices, their~     proposals post-hospital care, and provide reliable and fair information to the patient and~     his relatives.~      Estimating simultaneously the hazard for each of these three events can be complex. Indeed,~     a death event hinder the observation of re-hospitalization or institutionalization if death~     occurs before these events. The death should be considered a competing risk in these~     analyzes. Hospital readmission may modify the risk of death or institutionalization and~     should be considered as an intermediate factor for these event. This complexity cannot be~     accounted with classical statistical models, like logistic regression models.~      The purpose of this study is to use more appropriate statistical models (multi-state models)~     to better estimate simultaneously the risks of hospital readmission, institutionalization,~     and death of a patient given after hospitalization in AGU, and to show that accuracy of~     these estimations can be improved by taking into account complications that occurred during~     the stay in AGU.~   "
8221|NCT02949622|"~     The aim of this study is to identify the psychological, emotional and lifestyle variables~     that can have an influence on the different components of metabolic syndrome (MetS) and~     develop a program for change lifestyle in this patients.~   "
8222|NCT02949609|"~     After stroke, patients frequently suffer from arm or hand weakness. There are numerous~     rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is~     particularly interesting in cases for which impairment is severe, as many other forms of~     therapy are often impossible.~      During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb.~     Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection~     in the mirror, thereby creating the illusion that the contralateral, impaired limb is~     moving.~      The objective of this study is to better determine the efficacy of MT. The investigators~     will therefore compare recovery of arm function in two groups of patient, that perform a~     regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional~     therapy. One group performs MT and the other one performs a therapy in which the same~     movements are performed, but without the use of a mirror, with unrestricted view of both~     limbs. Allocation to each group will be randomized. Arm function will be evaluated by use of~     a scale before, during and after the 4 week period. The assessor for the primary outcome~     measure will not know in which group the patient is. There will be a total of 30 patients~     included over a one year study period.~   "
8223|NCT02949596|"~     Treatment of anal cancer has been always linked to quality of life. Recently, with~     development on radiotherapy technique, toxicities have been lowered with the maintenance of~     adequate rates of disease control. This trial intends to follow patients prospectively with~     questionnaires to evaluate sexual quality of life among patients who are who men who have~     sex with other men and have been subject to concurrent chemoradiotherapy with IMRT~     technique.~   "
8224|NCT02949583|"~     The mechanical control of supragingival biofilm is accepted as one of the most important~     measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental~     surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have~     demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients~     that prevent and control both supragingival biofilm and gingivitis, specially when used~     adjunctively to mechanical oral hygiene regimens.~   "
8225|NCT02949570|"~     To assess the efficacy of inecalcitol in combination with imatinib in CML patients with~     molecular residual disease on imatinib monotherapy.~   "
8226|NCT02949557|"~     DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has~     the potential for osteoinduction due to increased expression of bone morphogenetic protein~     (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to~     reconstruct bone defects. Decortication is performed as a part of guided bone regeneration~     (GBR) procedure as it enhances the healing process.Therefore a combination of decortication~     and bone graft when applied in periodontal intrabony defect would enhance the regeneration~     of periodontium.~   "
8227|NCT02949544|"~     This study aims to investigate the effects of water immersion and exercise on heart function~     and blood flow in patients with chronic stable heart failure.~   "
8292|NCT02948777|"~     Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal~     fasting triglyceride values. Humans are mostly in a postprandial rather than in a fasting~     state and therefore non-fasting triglyceride values reflect more accurately the continuous~     exposure of arterial wall to the substantial cholesterol load. Evolocumab lowers blood~     LDL-cholesterol. This study evaluates the effect of evolocumab on postprandial lipid~     metabolism in type 2 diabetes. All participants in this study receive evolocumab treatment.~   "
8228|NCT02949531|"~     Oxygen is routinely given to patients with common conditions such as COPD and heart failure.~     There is no evidence behind giving oxygen to patients specifically in heart failure due to a~     stiff heart.~      This study aims to explore the effect oxygen has on the ability of patients with chronic~     heart failure and the ability to exercise. Other common variables will be assessed such as~     heart rate and blood pressure to observe the response to varying concentrations of oxygen.~      The concentrations chosen are commonly offered in hospitals and indeed are being delivered~     through standard equipment found in all hospitals in the country.~      It is hoped that studying the effect of short term oxygen on patients with heart failure~     will help to identify the effectiveness of oxygen in longer term therapy for patients who~     are often breathless with a decreased exercise tolerance.~   "
8229|NCT02949518|"~     Enhanced recovery after surgery (ERAS) pathways have been shown to decrease length of stay~     and perioperative complications in a range of surgical specialties. To date, ERAS has not~     been studied in patients presenting for spine surgery. The investigators have recently~     developed an interdisciplinary pathway for spine surgery patients based on the latest~     available evidence and guidelines. The aim of this trial is to compare the investigators~     ERAS pathway with conventional perioperative management in patients undergoing 1-2 level~     posterior lumbar fusion.~   "
8230|NCT02949505|"~     A UK prospective, single-centre feasibility study investigating the effects of exercise~     therapy on functional capacity in patients on the waiting list for liver transplantation.~     Patients will receive a 12-week home prehabilitation program (daily step program; functional~     resistance exercise sessions; telephone health call or virtual clinic). The following will~     be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety,~     patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS~     questionnaire) and quality of life (EQ-5D)~   "
8231|NCT02949492|"~     Regulatory T cells (Tregs) suppress cytopathic immune responses and inhibit transplant~     rejection. Our goal is to exploit the Treg suppressive properties to induce transplantation~     tolerance. In contrast to effector T cells, Tregs constitutively express the high affinity~     IL-2 receptor, which makes them exquisitely sensitive to very low-doses of IL-2. We propose~     here to conduct a phase II clinical trial in which we will test the capacity of low-dose~     IL-2 to promote the selective expansion of endogenous Tregs in liver transplant recipients~     at the time immunosuppressive drugs are being discontinued. We expect this will promote Treg~     accumulation within the transplanted liver, shift the balance between effector T cells and~     Tregs, and facilitate the development of operational tolerance in patients unlikely to reach~     this state spontaneously. We expect the trial to start shortly after the initiation of the~     project and to provide robust evidence on the efficacy of IL-2 within 47 months.~   "
8232|NCT02949479|"~     Background: Adverse childhood experience have been described in sexual offenders but the~     link with the offence need to be further investigated. Investigators postulate that one of~     the clinical moderating factors could be dissociative experience, a consequence of these~     early adverse experiences reactivated during the offence. The purpose of the study is to~     estimate the prevalence of clinical dissociation during the offence in a male adult~     population referred to our center for a sexual offence and to explore its correlations with~     epidemiological and clinical data (personal, legal history, psychiatric comorbidities),~     clinical trauma and dissociation, prognosis estimates.~   "
8233|NCT02949466|"~     Using a double-blind, randomized controlled design to investigate the additional therapeutic~     effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of~     hyaluronic acid injections to patients with knee osteoarthritis.~   "
8234|NCT02949453|"~     Background: Previous suicide attempt is known to be a strong risk factor for repetition and~     repetition is common within the first year after an episode of deliberate self-harm (DSH).~     There has been growing interest in brief interventions for this population that are focused~     on maintaining long-term contact and/or offering re-engagement with services when needed.~     Despite telephone-delivered interventions have shown promising results in suicide reattempt~     prevention, subjective impact of such brief contact interventions and effectiveness~     mechanisms have never been evaluated.~   "
8235|NCT02949440|"~     To investigate the clinical application value of laparoscopic radical right hemicolectomy~     using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective~     randomized controlled clinical study.~   "
8236|NCT02949427|"~     The human microbiome is composed of unique groups of microorganisms occupying distinct~     habitats distributed throughout the human body. The Human Microbiome Project recently~     evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men)~     body sites. Much initial attention in the field of microbiome research has focused on the~     bacterial contribution to a healthy microbiome. However, it is clear that other~     microorganisms, including fungi and viruses, are also distributed throughout the human body~     and serve as functional components of the microbiome.~      The populations of microorganisms residing within the oral and nasal cavities make important~     contributions to human health and disease. These contributions may be especially important~     in immunosuppressed patients, including those patients receiving myelosuppressive~     chemotherapy or undergoing hematopoietic stem cell transplantation. In these patients,~     organisms typically considered as commensals can become pathogenic, either locally or~     systemically.~      This observational study is primarily undertaken to evaluate the oral and nasal microbiota~     and to define the population of fungal organisms residing within the oral and nasal cavities~     in pediatric oncology patients before and after receiving protocol-directed chemotherapy and~     associated supportive care.~   "
8237|NCT02949414|"~     This is a phase I study to evaluate the safety, efficacy and tolerability of a novel~     tracheal replacement therapy using cadaveric de-cellularised tracheal scaffold and patients'~     own mesenchymal cells isolated from a sample of their bone marrow in patients' who suffer~     from severe tracheal malacia or stenosis.~   "
8238|NCT02949388|"~     This study is designed as a randomized, double blind, parallel group, placebo-controlled~     trial to study the efficacy and safety of two oral doses of Prurisol administered twice~     daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.~   "
8838|NCT02941523|"~     The study evaluates the safety and activity of NOX66 in patients with refractory solid~     tumors that are non responsive to standard therapies.~      This is a two part with a potential third part, open-label, multicenter, dose escalation~     study of NOX66 as monotherapy and in combination with carboplatin.~   "
8239|NCT02949375|"~     Primary objectives:~      To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28,~     following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with~     chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a~     marker of liver inflammation.~      To assess the safety and tolerability of GRI-0621 at these two doses.~      Secondary objectives:~      To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28,~     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with~     chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a~     second marker of liver inflammation.~      To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in~     serum ALT levels from baseline measured at the different trial time points.~      To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following~     daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver~     disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or~     apoptosis.~      To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28~     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.~      To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic~     liver disease.~      Exploratory objectives:~      To assess the effect, if any, that the investigational product may have on serum~     triglyceride levels.~   "
8240|NCT02949362|"~     The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of~     children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a~     long-term period. It will evaluate how these children fared after the TED-C13-003 study~     ended. This study will also offer teduglutide treatment to eligible subjects, regardless of~     treatment received in TED-C13-003.~   "
8241|NCT02949349|"~     This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate~     Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the~     maintenance therapy of lupus nephritis.~   "
8242|NCT02949336|"~     The proposed study is a prospective collection of health related personal data~     (observational study). A total of approximately 10 subjects with traditional medial SIGMA®~     High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High~     Performance Partial Knee System are analyzed during sitting onto a chair and getting up,~     deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and~     stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed~     tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and~     ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for~     Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and~     exclusion criteria.~      The primary objective is to quantify and describe the three-dimensional kinematics for~     patients with a traditional medial SIGMA® High Performance Partial Knee System (functional~     ACL and tibial posterior slope matching the native bone) during these daily activities.~      The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA®~     High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted~     at a 50% reduced tibial posterior slope relative to the native knee.~   "
8243|NCT02949323|"~     The incidence of nephrolithiasis in children has been reported to increase by approximately~     6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent~     rate. Investigators aimed to determine the metabolic risk factors in Chinese children~     through metabolic evaluation.~      In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western~     country wether adapt to Chinese children, investigators aim to determine normal urine levels~     of oxalate and citrate in children without kidney stone.~   "
8244|NCT02949310|"~     Breast cancer surgery is known to cause severe acute postoperative pain, which can persist~     for a long time. The investigators administered nefopam preventively to patients undergoing~     total mastectomy or modified radical mastectomy with axillary lymph node dissection or~     sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative~     pain.~   "
8245|NCT02948491|"~     Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in~     order to estimate the effectiveness, six (6) months after hospital discharge, of music~     therapy on the intra-hospital evolution and neurodevelopment of preterm neonates~     (gestational ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in~     the Bucaramanga Metropolitan Area.~   "
8246|NCT02948478|"~     Precariousness is a multifactorial concept that can be broken down in the form of economic~     insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has~     an impact on health that is difficult to assess precisely because it also impacts on other~     factors that may themselves influence health. Therefore, the understanding of the impact of~     precariousness on health involves studying individuals in their context.~      Our study is designed to assess the impact of precariousness on the history of breast~     cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual~     analysis. Indeed, the socio -economic and geographical inequalities affect the history of~     breast cancer, treatment and its delay and post- treatment rehabilitation.~      The main objective of this project is to compare the stage of disease at diagnosis~     (according to the TNM classification) in deprived and non deprived patients. The secondary~     objectives are to compare in the two groups - the socio-economic and geographical~     inequalities - the direct and indirect costs related to the management, the out-of pocket~     costs and to describe, based on individual inequalities identified, the pathway of care of~     the patient.~      These objectives will be pursued in the framework of an observational cohort study,~     prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each~     precarious patient will be matched to a non- precarious patient in the same age group,~     regardless of the center. The study will include any patient resident in Ile de France~     seeking treatment for breast cancer, regardless of the stage.~   "
8293|NCT02948764|"~     The main purpose of the study is to evaluate the potential of a minimal invasive,~     vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in~     the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.~      The study is designed as a multicenter, confirmative, one-armed,~     intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the~     applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify~     the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.~   "
8247|NCT02948465|"~     Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics~     for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA)~     and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in~     particular in proximal occlusion. Experimental studies suggest that neutrophils could play~     an important role in the thrombus development via the organization of a network (NET) within~     the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase~     the rate of recanalisation and thus improve the neurological prognostic after a cerebral~     infarct.~      The aim of the research is to Study of the biochemical and histological composition of the~     stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the~     thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).~   "
8248|NCT02948452|"~     This study is designed to understand responsiveness to reward in adolescents with~     restricting-type anorexia nervosa compared with non-clinical controls, and how it is~     affected by potential-threat perception.~   "
8249|NCT02948439|"~     Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness~     of blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors.~     Previous work by the investigators has demonstrated that during pregnancy, the part of the~     nervous system responsible for cardiovascular function (the sympathetic nervous system) is~     hyperactive. The investigators also know that in women who develop high blood pressure~     during pregnancy that sympathetic nervous system activity is even higher. Yet, very little~     is known about why this occurs and how this might be affected.~      Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient~     exercise to meet current guidelines. This is important because hyperactivity of the~     sympathetic nervous system is observed in other inactive populations and has been linked to~     adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart~     attack, and stroke. Indeed, in 2011, the American Heart Association stated that inactivity~     was a risk factor as potent as cigarette smoking for the development of future~     cardiovascular disease in women.~      The investigators' work and others have demonstrated that exercise during pregnancy is~     beneficial for both the mom and baby; however, the effect of prenatal exercise on~     neurovascular function is not known. If exercise is effective in controlling the increase in~     sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular~     system, this may help prevent the development of high blood pressure or other cardiovascular~     problems during pregnancy.~   "
8250|NCT02948426|"~     Ovarian cancer is a leading cause of cancer death in women. Monocytes are white blood cells~     that slow tumor growth. Interferons (IFNs) are molecules that help immune cells fight~     cancer. Researchers want to stimulate monocytes with IFNs. They want to test if these~     stimulated monocytes combined with the drugs Sylatron and Actimmune can shrink tumors and~     slow the progression of cancer.~      Objective:~      To test how well IFN stimulated monocytes, with Sylatron and Actimmune, kill tumor cells.~      Eligibility:~      Women ages 18 and older with certain ovarian, fallopian tube, or peritoneal cancers~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Scan~      Results or sample from previous biopsy~      Participants may have a tumor sample taken.~      Participants who do not have a port will have a catheter placed inside the abdominal cavity.~     It will be used to give the treatment.~      Participants will have visits for 4 days of each 28-day cycle. This includes overnight~     observation.~      Participants with ascites fluid in their abdominal cavity will have it sampled twice.~      Each cycle, participants will have:~      Blood tests~      Leukapheresis. Some blood is removed and put through a machine that separates out the~     monocytes. The rest of the blood is returned to the body.~      Infusion of the monocytes and study drugs~      Participants will have weekly phone calls in Cycle 1 and scans every 2 cycles.~      Participants will continue treatment until they can no longer tolerate it or their cancer~     gets worse.~      Participants will have a visit about 1 month after stopping treatment, then monthly phone~     calls....~   "
8251|NCT02948413|"~     Background:~      A cancer diagnosis is a threat to life and bodily integrity. This can cause people with~     cancer to experience traumatic stress. Researchers want to better understand the types of~     stress and emotional reactions people with cancer experience. They also want to know if the~     stress people with cancer have had during their life affects their stress related to cancer.~      Objective:~      To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress~     symptoms in people with cancer.~      Eligibility:~      People ages 18 and older who have had or are currently getting care from the NIH Clinical~     Center for one of these cancers:~      Leukemia~      Lymphoma~      Mesothelioma~      Prostate cancer~      Design:~      Participants will be screened with name, date of birth, and diagnosis.~      Participants will allow access to their medical records.~      Participants will complete, online or in person, a demographic sheet and 3 questionnaires:~      The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10~      minutes to complete.~      The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and~      takes about 5 minutes to complete.~      The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4~      minutes to complete.~   "
8252|NCT02948400|"~     The investigators will conduct a non-inferiority clinical trial to evaluate whether children~     trained in pedestrian safety amidst a Google Cardboard virtual environment achieve~     equivalent levels of pedestrian safety to children trained in a full semi-immersive virtual~     pedestrian environment~   "
8253|NCT02949284|"~     This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works~     with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone~     in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause~     the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist~     ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may~     fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may~     either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist~     ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in~     treating patients with prostate cancer.~   "
8294|NCT02948738|"~     Children with asthma are admitted for asthma attacks very frequently in the U.S. The~     families and children are given basic education about asthma but studies are needed to~     improve this education so that it makes a meaningful difference in health outcomes and~     asthma care. This study compares two inpatient education models for children hospitalized~     with asthma.~   "
8254|NCT02949271|"~     The aim of this prospective, doubled-blinded randomized study is to compare two modes of~     epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus~     continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing,~     for providing labor epidural analgesia. The primary outcome will be the volume of local~     anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus,~     labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of~     successful to unsuccessful attempts, frequency of hypotension, duration of first and second~     stages of labor and level of patient satisfaction. The investigator plans to enroll 120~     nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The~     subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1%~     with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be~     analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be~     analyzed using Chi-square test or Fisher's exact test as appropriate.~   "
8255|NCT02949258|"~     Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive~     tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant~     chemotherapies have not improved the survival rate. The purpose of this study is to~     determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and~     intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.~   "
8256|NCT02949245|"~     272 subjects with high risk adult spinal deformity requiring surgical correction were~     enrolled in the previous prospective multi-center international Scoli-RISK-1 study. High~     risk patients were defined by either their diagnoses and/or the type of surgical~     intervention as listed in the inclusion criteria. Neurological complications in the form of~     new motor and sensory deficits were monitored prospectively in all patients at hospital~     discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after~     the surgery. The relationship to the surgical intervention was assessed in all new deficits.~      Regression analyses were used to evaluate the association between patient demographics,~     co-morbidities, treatment history, spinal deformity characteristics, surgical~     characteristics, non-neurologic complications and pre-surgical status to occurrence of a~     neurologic deficit after surgery.~      All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year~     FU visit.~   "
8257|NCT02949232|"~     Treatment with prednisolone can be used as a proof of concept to investigate the possibility~     of immune modulation as a treatment for schizophrenia. It is expected that daily treatment~     with prednisolone in addition to antipsychotic treatment reduces psychotic symptoms and~     improves cognition, as compared to placebo. The investigators propose to investigate the~     effects of administering the corticosteroid prednisolone versus placebo in addition to~     standard antipsychotic medication in patients with early stage schizophrenia or related~     disorders, hypothesizing that a decrease in the overall low-grade cerebral inflammation due~     to prednisolon treatment will be expressed as a decrease in overall symptom severity.,~     Secondly, addition of prednisolone is hypothesised to slow down cognitive deterioration in~     recent-onset psychosis patients. Finally, the investigators aim to determine whether~     indirect immunological parameters of the hypothesised low grade inflammation status in~     schizophrenia are shifted due to the addition of prednisolone.~   "
8258|NCT02949219|"~     This phase II trial studies how well pembrolizumab works in treating patients with small~     bowel adenocarcinoma that has spread to other places in the body or that cannot be removed~     by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
8259|NCT02949206|"~     The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1~     (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of~     JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function~     (Part 2) in healthy male participants.~   "
8260|NCT02949193|"~     This is a randomized, double-blind, active-controlled, phase III clinical trial to~     investigate the efficacy and safety of evogliptin when added to ongoing metformin~     monotherapy in patients with type 2 diabetes who have inadequate glycemic control~   "
8261|NCT02949180|"~     Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App~     in a prospective cohort.~   "
8262|NCT02949167|"~     Approximately 24,000 women attend a follow-up care program after end of primary treatment~     for breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled~     trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of~     recurrence, good management of symptoms and cost-effectiveness. The primary aim of this~     randomised, controlled trial is to test whether a nurse-led individually tailored symptom~     management program (MyHealth) will significantly reduce reported symptoms among BC patients~     following primary treatment compared to physician-led scheduled follow-up. Secondary, the~     investigators will examine patient activation (self-management), anxiety, depression, fear~     of recurrence, work ability, time to recurrence, health behavior changes, health care~     utilization and financial costs in the two arms.~      The MyHealth program provides patients with a nurse-led education focusing on management of~     symptoms, an electronic platform to report symptoms to the nurses and support in symptom~     management and navigation of patients to appropriate health care services.~   "
8263|NCT02949154|"~     A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.~   "
8264|NCT02949141|"~     This study is designed to evaluate the use of lung ultrasound compared to chest x-ray to~     diagnose pneumonia in Nepal. Given the ease, portability, and relative ease of teaching~     ultrasound, this would be potential technology available for many clinicians throughout~     Nepal to use for adult and pediatric patients presenting with suspected pneumonia. This~     would be especially useful in remote areas where clinicians have limited access to x-rays.~     Despite its utility, use of ultrasound to diagnose pneumonia in resource-limited settings~     like Nepal has not yet been studied. Therefore, this study is designed as a prospective,~     clinical diagnostic study to evaluate patients presenting with suspected pneumonia using~     diagnostic imaging of beside ultrasound compared with chest x-ray using computed tomography~     as the gold standard for diagnosis of pneumonia.~   "
8265|NCT02949128|"~     The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity~     in adolescent and adult patients with aHUS who have not previously used a complement~     inhibitor.~   "
8266|NCT02949115|"~     Aside from aging, numerous factors increase the risk for developing cardiovascular disease~     (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular~     endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and~     hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese~     individuals. These postprandial responses are likely largely due to activation of~     pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the~     postprandial state, this may further impair cardiovascular health in aging overweight/obese~     individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta~     vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids,~     phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and~     their metabolites have been shown to have antioxidative, anti-inflammatory, and~     cardiovascular-protective effects. These effects, particularly the cardiovascular-protective~     effects, have been primarily attributed to its high content of nitrate since it is converted~     to nitric oxide independent of the vascular endothelium via the enterosalivary~     nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other~     potentially beneficial bioactive compounds and few studies have aimed to determine whether~     these compounds work independently, additively, or synergistically in exerting these~     effects. Given the findings of previously conducted research in the broad area of red~     beetroot juice consumption and human health, it can be suggested that: 1) acute red beetroot~     juice consumption may prevent or attenuate the adverse postprandial responses to consuming a~     high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red~     beetroot may improve underlying factors contributing to these exaggerated responses.~     Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole~     red beetroot juice consumption compared with its bioactive components in attenuating~     postprandial vascular endothelial dysfunction and adverse cardiometabolic responses to a~     high-fat meal; and 2) to gain insight into the underlying mechanisms responsible.~   "
8267|NCT02949102|"~     The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce~     reward region response to intake of high-sugar food and ad lib candy intake and whether the~     GA lozenge reduced reward region response to anticipated intake of high-sugar food and~     high-sugar food pictures relative to a placebo lozenge.~   "
8268|NCT02949089|"~     This study intends to provide information on the safety and tolerability of repeated oral~     doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study~     of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to~     best address the study goals.~   "
8269|NCT02949076|"~     Cancer and its treatment can have profound effects on skeletal muscle, the most~     well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations~     negatively impact quality of life, treatment decisions and survival. Despite these~     consequences, the factors promoting these adaptations remain poorly defined and understudied~     in human patients. To address this gap in knowledge, our goal in this study is to examine~     the role of muscle disuse as a regulator of muscle size and function in human cancer~     patients~   "
8270|NCT02949063|"~     A mixed methods design was used to explore the outcomes of a 6-week, occupational~     therapy-led Comfortable Cafeteria program designed to build capacity of cafeteria~     supervisors to create a positive mealtime environment so that all students can successfully~     participate in and enjoy their meal and socialization with peers.~   "
8271|NCT02949050|"~     Patients demonstrated allergic to corn pollen and timothy grass pollen (by allergy testing)~     who have undergone 1 to 2 years of subcutaneous allergen immunotherapy (SCIT) containing~     timothy grass extract with moderate symptomology (as documented via rhinitis symptom score~     surveys) will constitute the treatment group. Those who previously chose not to undergo SCIT~     who have documented symptomology and are skin test positive to corn pollen will constitute~     the control group. Prospective symptom score analyses and retrospective quality of life~     assessments (RQLQ) will be the primary and secondary efficacy outcome measures.~   "
8272|NCT02949037|"~     Multi-site feasibility study designed to assist type-2 diabetes patients in self-care~     activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood~     pressure cuffs, glucometers, and activity monitors) for both intervention and control~     groups. Those in the intervention group will have the devices linked too a mobile health~     care environment that provides key benefits that include: device data trending, reinforcing~     tailored behavioral messages, and enhanced communication with the clinic.~   "
8273|NCT02949024|"~     This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA~     alone or in combination with intravitreal aflibercept in subjects with diabetic macular~     edema associated with diabetes mellitus.~   "
8274|NCT02949011|"~     The primary objective of this study is to evaluate the efficacy of a single, oral dose of~     S-033188 compared with placebo by measuring the time to improvement of influenza symptoms in~     patients with influenza presenting within 48 hours of symptom onset.~   "
8275|NCT02948998|"~     Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease with high~     mortality. Heart failure is the most common complication (about 50% incidence) in these~     patients. However, it is lack of efficiency medicine to treat heart failure for HCM~     patients.~      Recent studies found fibrosis was common in HCM patients and it was progressive with aging.~     Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to~     measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM~     patients.~      Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies~     suggested that aldosterone might participate the development of fibrosis in HCM patients.~     Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on~     inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.~      Thus, the investigators hypothesize that fibrosis is one important reason of heart failure~     for HCM patients. The purpose of this study is to investigate whether small dosage and early~     prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis~     progress and improve patients' symptoms.~      This study is a multicenter, randomized, controlled and open-label study being conducted in~     4 centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy~     of spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit~     260 participants with definite HCM diagnosis. Then these participants will be randomized to~     two groups-- control group (not taking spironolactone) and spironolactone group (taking~     20mg spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter,~     electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium,~     liver enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random~     allocation and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV.~     The extent of LGE+% (the area showing LGE divided by the total area) before and after 2-year~     experiment and the increase of LGE+% after 2-year experiment will be compared between~     control and spironolactone groups. Meanwhile, symptoms, New York Heart Association~     classification of cardiac function, arrhythmia, proBNP and TnT etc. will be compared between~     two groups.~   "
8276|NCT02948985|"~     Evaluation of individual peripheral blood circulating tumor cells combined with tumor marker~     detection of efficacy of chemotherapy in patients with advanced colorectal cancer: A~     observational clinical trial~   "
8277|NCT02948972|"~     The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial.~     This study includes patients presenting colorectal DIE and infertility. Patients will be~     randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE~     prior to ART and the other group underwent ART alone (ratio 1:1)~   "
8304|NCT02948608|"~     The objective of the study is to investigate extra-articular manifestations, pain~     mechanisms, patient-reported outcomes, comorbidities and association between these~     conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to~     assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.~   "
8278|NCT02948959|"~     Primary Objective:~      To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled~     persistent asthma.~      Secondary Objectives:~      To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:~        -  The safety and tolerability of dupilumab.~        -  The effect of dupilumab in improving patient-reported outcomes (PROs).~        -  The dupilumab systemic exposure and incidence of anti-drug antibodies.~        -  To explore the association between dupilumab treatment and pediatric immune responses~          to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal~          trivalent/quadrivalent influenza vaccine.~   "
8279|NCT02948946|"~     The purpose of this study is to evaluate how well an investigational blood test performs.~     The study will look at the sensitivity and specificity of a blood-based multitranscriptome~     assay (NETest).~   "
8280|NCT02948933|"~     The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the~     real-world immunization setting~      Primary Objective:~        -  To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs)~          occurring over a period of six (6) months after each Dengvaxia® dose administration;~        -  To quantify the association between Dengvaxia® and each of the selected AEs and SAEs~          for which a risk window after vaccination can be defined, using estimates of relative~          risk~        -  To monitor the occurrence and frequency of hospitalized dengue disease as well as any~          other SAEs leading to hospitalization or death, including new and previously~          unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years~          after the first Dengvaxia® dose administration.~      Secondary objectives:~        -  To identify risk factors for hospitalized dengue disease (severe or not) among subjects~          vaccinated with Dengvaxia®;~        -  To describe the frequency of hospitalized dengue disease and/or other SAEs or selected~          AEs according to the number of Dengvaxia® doses and/or interval between doses.~   "
8281|NCT02948920|"~     A prospective double-blinded randomized controlled study to determine efficacy of ephedrine~     in preserving core temperature in patients under neuraxial spinal anesthesia for knee~     arthroscopic surgery.~   "
8282|NCT02948907|"~     Several benign and malignant diseases are associated with hilar and mediastinal~     lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the~     visualization of tissue elasticity and Tissue Harmonic Imaging (THI) might be useful for~     the differentiation of benign and malignant lymph nodes.~   "
8283|NCT02948894|"~     Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device~     (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced~     Ejection Fraction (HFrEF) and obstructive sleep apnea (OSA). The investigators hypothesize~     that the AHI was 60% lower after 3-month treatment with MAD than with sham MAD.~      Secondary aims: The investigators also aim to determine i. the interaction between ethnicity~     (Chinese, Malay, Indians) and the effects of MAD in lowering AHI; ii. the effect of MAD on~     cardiac remodeling (LVEDVI assessed by cardiac magnetic resonance imaging [CMR]); iii. the~     characteristic craniofacial skeletal anatomy (using coned beam computed tomography [CT])~     associated with OSA in Asian patients with HFrEF; iv. the association between self-reported~     adherence to MAD and cardiac remodeling; v. the effects of MAD on biomarkers of HF~     (N-terminal pro-B-type natriuretic peptide [NT-proBNP],high sensitivity cardiac troponin T~     [hs cTnT], high-sensitivity C-reactive protein [hs-CRP], and ST2);~      Rationale: OSA is associated with incident HF. The investigators will study Asian patients~     because a body of evidence suggests mechanisms for OSA differ between Asians and Caucasians.~     While obesity is the major contributing factor in Caucasians, craniofacial skeletal anatomy~     (short mandible, maxilla, and cranial base and a large mandibular volume) plays an important~     role in the development of OSA among Asians. Using cone beam CT, it has been shown that~     Asians have shorter mandibular, maxillary, and cranial base lengths and a greater mandibular~     volume compared with Caucasians. Using a MAD to adjust maxillary-mandibular~     juxta-positioning to maintain a patent airway may be an ethnic-specific approach to treat~     OSA in Asians.~   "
8284|NCT02948881|"~     The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken~     once monthly versus placebo on bone quality and strength at the hip at one year.~   "
8285|NCT02948868|"~     This study will correlate MA-abstinence outcomes from an 8-week contingency management (CM)~     program of voucher- based incentives using an escalating schedule that has been successfully~     implemented as an adjunct to MA treatment by the investigators collaborators in the United~     States. Pre- and post- treatment neuroimaging and neurocognitive assessments will assist in~     identifying structures and/or processes that may represent targets for development of novel~     behavioral and/or medication therapies.~   "
8286|NCT02948855|"~     Initially investigators will find LncRNA which to be able to affect Notch2 signaling~     pathway; then confirm the relationship between Notch2 and LncRNA, and analysis the~     regulation mode of LncRNA to Notch2 signaling pathway, and to observe the correlation~     between LncRNA and thymoma complicated with autoimmune diseases.~   "
8287|NCT02948842|"~     The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase~     (XIAFLEX®) in treating urethral strictures.~   "
8288|NCT02948829|"~     The purpose of this study is to assess the cellular immune responses following 2 doses of~     tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.~   "
8289|NCT02948816|"~     Participants will be exposed to 3 conditions, in random order:~        1. A Facebook page where 70% of posts are related to food.~        2. A Facebook page where only 20% of posts are related to food.~        3. A control condition (colouring quietly).~      During each of the above conditions participants will be provided with identical snacks. The~     snacks will be weighed before and after each condition, to determine whether there is a~     change in food intake across the 3 conditions.~   "
8290|NCT02948803|"~     The aim of this smartphone-based intervention study is to determine whether a newly~     developed app is effective in promoting an active lifestyle in low educated working young~     adults.~   "
8291|NCT02948790|"~     The aim of this study is to assess the auditory nerve functionality with an intraoperative~     approach following a surgical removal of acoustic neuroma in patients with severe to~     profound sensorineural hearing disabilities.~   "
8343|NCT02947997|"~     The purpose of this study is to test the safety and feasibility of a redesigned tethered~     capsule catheter that contains an integrated micro-motor. Investigators will be testing~     imaging of this new technology in healthy volunteers.~   "
8295|NCT02948725|"~     Based on the current state of knowledge and gaps in the literature we will conduct an~     intervention study to explore novel treatment and rehabilitation of patients at Royal~     University Hospital (RUH) with motor deficits following stroke. This project has the~     following objectives:~        1. To determine if cross-education, in addition to standard rehabilitation leads to better~          recovery of upper limb function for stroke patients with hemiparesis.~        2. To incorporate functional brain activation as measured by functional magnetic resonance~          imaging (fMRI) to examine the neural mechanisms associated with changes in motor~          function of the paretic arm post-stroke.~        3. To use diffusion tensor imaging (DTI) tractography to measure connectivity and examine~          the extent to which white matter tract thickness correlates with preserved motor output~          in patients post-stroke.~   "
8296|NCT02948712|"~     The purpose of this study is to help adolescents and young adult cancer survivors address~     their psycho-social needs during the transitional period. The transitional period begins at~     completion of cancer treatment and continues throughout that first year. Patients often~     report this period can be difficult and distressing in many areas of life. This study will~     use a simple tool to measure, on a regular basis, the level of distress a young adult may be~     feeling. Based on this assessment additional mental health support and intervention can be~     recommended to help cancer survivors cope and enhance their feelings of well-being.~   "
8297|NCT02948699|"~     The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce~     the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition~     conditions and clinical outcomes of patients. This research tries to evaluate the nutrition~     status at the baseline, before and after radiotherapy, during the follow-up by the body mass~     index, hematological indexes, immunological indexes, and nutrition questionnaires including~     PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the~     investigators aim to find an optimized assessment model and the best nutrition support~     patterns.~   "
8298|NCT02948686|"~     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,~     that aims to evaluate the best application strategy when using a new Universal Adhesive~     system, Ambar Universal (FGM, Joinville, Brazil). Volunteers will be selected and~     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be~     informed and sign a term of clarification and consent. 38 enrolled patients will receive~     four Class V dental restorations, made in four different ways, one from each experimental~     group, using the same universal self-etching adhesive system, which is the tested material~     in this study. Non-carious cervical lesions will receive the applied adhesive system in 4~     different protocols separated by groups. Group Self Etching (SET) (control): no~     conditioning, the adhesive system will be used in 55 teeth, according to the manufacturer's~     instructions, in the self-etching mode. The adhesive system will be brushed during 10~     seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds,~     air-dried during 10 seconds and activated during 10 seconds with Light Emission Diode (LED)~     light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 15~     seconds, only in enamel in 55 teeth. This acid will be removed using water, the cavity will~     be air-dried, and then, the adhesive will be applied according to the manufacturer's~     instructions, as described in group SET; Group SETT (Self-Etching with extended time):~     Similar to Group SET, but during the 2 applications, the adhesive systems will be brushed~     during 20 seconds, and not during 10 seconds as described in Group SET; Group SETL~     (Self-Etching with extended number of layers): The adhesive system will be applied as~     describe in Group SET, but the researchers will apply 4 layers, and not 2 layers, as~     described in Group SET. After applying the adhesive, the restorations will be made with~     composite resin, and evaluated every 6 months for pain assessment, shape, staining or~     recurrent caries, using scores. To determine in which group each tooth will be enrolled, the~     authors will randomize the teeth.~   "
8299|NCT02948673|"~     Objectives: The research focus of the study is the production of reactive oxygen species~     (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH)~     supplementation and in response to acute exercise.~      Oxidative stress is suggested as a possible causative factor in the pathophysiology of~     skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the~     cell and thus, a crucial protector against oxidative stress and insulin resistance. It has~     been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH~     infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in~     patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH~     supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in~     patients with T2D and healthy controls.~      Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in~     patients with T2D and this effect will be linked to a reduced mitochondrial ROS production~     in the skeletal muscle.~      In contrast to the link between oxidative stress and insulin resistance, ROS produced in~     response to exercise is an important physiological stimulus as it is suggested to play a key~     role in the beneficial mitochondrial biogenesis observed in response to training. It has~     been reported that some patients with T2D have a diminished mitochondrial biogenesis in~     response to training, but the reason for this defect is not known. We want to investigate~     the link between exercise-stimulated ROS production and the mitochondrial biogenesis~     response in patients with T2D and healthy controls in response to acute exercise at two~     different intensities.~      Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic~     ROS level), we speculate that a lower exercise intensity, leading to a lower~     exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for~     mitochondrial biogenesis in patients with T2D.~   "
8300|NCT02948660|"~     The research contains three parts. Part 1: To explore the evaluating and prognostic values~     of electroencephalography sleep cycle combined with the serum melatonin and orexin level of~     patients with disorders of consciousness; Part 2: To assess the efficacy of the~     wake-promoting function of zolpidem tartrate in comotase patients; Part 3: To assess the~     efficacy of the wake-promoting function of melatonin in comotase patients.~   "
8301|NCT02948647|"~     This dietary intervention aims at developing a more personalized and targeted treatment for~     NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The~     investigators previous publications have shown that this particular demographic has a~     greater than 2-fold higher liver fat compared to GC and CC individuals. They have also~     demonstrated a significant gene*dietary sugar interaction with a significant association~     between liver fat and dietary sugar intake in GG subjects with no such association in GC or~     CC individuals. These studies suggests that different dietary strategies may have~     differential effects on reducing liver fat, depending on PNPLA3 genotype. To confirm this,~     the investigators will complete a clinical trial in 120 overweight and obese Hispanic~     children (12 - 18 years) with clinically verified NAFLD who will be randomized to one of two~     12-week interventions:~      Group 1 (standard of care control group): Dietary intervention focused on healthy eating~     (n=60; 30GG + 30GC/CC)~      Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating~     and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal~     of 10% of daily calories (n=60; 30GG + 30GC/CC)~      The following outcomes will be measured before and after intervention: Total liver fat~     fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic~     resonance imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body~     fat by DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and~     inflammatory markers, gut microbiome, and insulin and glucose response to an oral glucose~     challenge. The investigators hypothesize that liver fat fraction, liver fibrosis, and~     metabolic outcomes, such as fasting and 2h-glucose and insulin, and inflammatory biomarkers,~     will show significantly greater improvements with sugar reduction relative to control. In~     addition, the investigators also hypothesize a treatment*genotype interaction whereby the~     reduction in liver fat will be significantly greater in GG relative to CC/CG subjects.~   "
8302|NCT02948634|"~     The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for~     its effects on pain, fatigue, and physical function in individuals with fibromyalgia.~   "
8303|NCT02948621|"~     The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal~     suture approach without any incision. It could reduce the complications associated with~     current surgical techniques while obtaining the target gastric restriction, weight loss,~     comorbidities and quality of life improvement.~      The primary objective of this study is to assess weight loss after endoscopic sleeve~     gastroplasty in patients with morbid obesity.~   "
9216|NCT02936583|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
8305|NCT02948595|"~     The long term goal of our research is to develop a curriculum for Obstetrics and Gynecology~     resident physicians that regularly employs use of video assessment to improve surgical~     skills. Regular use of video feedback may enable improved self-assessment and allow for~     formal documentation of proficiency. The overall objective is to compare the use of video~     feedback to use of structured verbal feedback in the simulated task of laparoscopic vaginal~     cuff closure.~   "
8306|NCT02948582|"~     The study assessed the safety and ability of an orally inhaled medicine [i.e.,~     Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered~     using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD).~     Each patient randomly received several, single doses of GIS, or placebo, separated by~     approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24~     hours and blood was collected to measure how much GIS was in the bloodstream. The study was~     conducted to find the once-a- day GIS dose that produced the highest improvement in lung~     airflow using the eFlow nebulizer.~   "
8307|NCT02948569|"~     Metabolic syndrome increases the risk for development of heart disease. Another condition~     associated with metabolic syndrome is fatty liver disease which is also referred to as~     nonalcoholic fatty liver disease (NAFLD). Recently, drugs that block fatty acid synthesis~     have been developed to treat cancer. These drugs are now being considered for the treatment~     of NAFLD. A research test designed to measure liver fatty acid synthesis involves~     consumption of a sugary solution and measurement of blood fats over a six-hour period. The~     present study will test the drug 3-V Bioscience-2640 in healthy subjects with~     characteristics of the metabolic syndrome before and after 10 days of treatment to determine~     if 50 mg/d significantly reduces liver fat synthesis and lowers liver fat storage.~   "
8308|NCT02948556|"~     The purpose of this study is to identify daily activity patterns, negative life events and~     autonomic abnormalities that may be related to non-improvement in myalgic~     encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and~     behavioral intervention trials, roughly 50% of patients report worsening or unchanged~     illness. The proposed four year study would be the first to look at the relation between~     illness non-improvement, patient activities at home and autonomic function. Our long-range~     goal is to identify physiological signals and activity patterns that predict non-improvement~     and relapse and develop a self-management program that prescribes improvement-linked~     behaviors and discourages non-improvement activities.~   "
8309|NCT02948543|"~     Open label, randomised phase 3 trial of the addition of Mitomycin C to BCG as adjuvant~     intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to~     compare disease-free survival between treatment arms: BCG alone versus Mitomyicn C in~     addition to BCG.~   "
8310|NCT02948530|"~     Classically lung elastance and transpulmonary pressure are measured from the difference in~     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure~     divided by the tidal volume. This requires the presence of a esophageal balloon catheter~     which is cumbersome and costly. In this study values obtained as described above are~     compared to values obtained with a new method in which a stepwise increase in positive~     endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which~     corresponds to the tidal volume which the patient is ventilated with. The measurements are~     performed in sedated and mechanically ventilated patients in the intensive care unit.~   "
8311|NCT02948517|"~     Time restricted feeding (TRF) is a novel form of intermittent fasting that involves~     confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting.~     TRF is effective for weight loss and cardio-protection in obese adults. It is of great~     interest to see whether subjects can adhere to TRF for longer periods of time, and to see~     what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this~     trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese~     adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in~     plasma lipids, blood pressure, insulin resistance, and inflammatory markers.~   "
8312|NCT02948504|"~     Intracranial aneurysms are common in the general population. The overall prevalence of~     unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without~     specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than~     before, UIAs are increasingly being detected. Most patients with small aneurysms (less than~     5mm) are incidentally found in clinical practice. Some studies indicate that the majority of~     patients with UIAs, particularly with small aneurysms (<7mm), have a low risk of rupture,~     and others have found that small ruptured aneurysms have a high proportion in patients with~     SAH. Therefore, there is a lot of controversy regarding which small aneurysms can be left~     untreated, or which aneurysms are needed to be treated with clipping or coiling.~      The prevalence varies widely among different detection methods, race/ethnicity or patients~     with other inherited diseases. Although a wealth of data is available for the natural~     history of UIAs, the true natural history remains unknown because case selection bias occur~     in almost all studies. However, data on Chinese UIA is unknown. Using the MR angiography~     (MRA) to detect aneurysms, the prevalence is 7% of selected adult population in China.~     Therefore, small UIAs are very common and are increasingly being detected in clinical~     practice. Conservative treatment, surgical clipping and endovascular coiling are the three~     treatment options for UIAs. The optimal treatment remains controversial, particularly for~     small aneurysms (less than 7mm). To date, no clinical trials have compared the safety and~     efficacy between conservative treatment and surgical clipping or endovascular coiling for~     UIAs. It may be impossible to conduct the randomized controlled study considering aneurysm~     ruptured as a devastating event. However, surgical clipping or endovascular treatment itself~     carries a risk of immediate morbidity or mortality. Therefore, a substantial variability~     widely exists in treatment decision-making for UIAs, and this may lead to a great~     variability in clinical recommendations.~      Our study is a prospective observational study to identify the incidence of rupture of small~     aneurysms in the first year after the diagnosis of the aneurysm which is left untreated.~     Meanwhile, we determine the differences of outcomes, procedural complications, and rates of~     retreatment between surgical clipping and endovascular coiling for small UIAs in China.~   "
8313|NCT02948387|"~     Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in~     patients with Type II and II open fractures is safe and effective.~   "
8314|NCT02948374|"~     Critical care patients are at a high risk of developing delirium and impaired cognitive~     function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate~     the pathophysiology behind delirium in the ICU and subsequent development of cognitive~     dysfunction in ICU survivors.~      Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without~     delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will~     also be obtained in healthy age- and sexmatched controls undergoing surgery.~   "
8315|NCT02948361|"~     Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have~     breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s),~     standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR~     recommendations.~      If available, subjects may provide copies of their breast imaging exams and related reports.~      Demographics and medical history will be collected.~   "
8316|NCT02948348|"~     This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety,~     efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody~     drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and~     subsequent surgical therapy in patients with locally advanced resectable rectal cancer.~   "
8317|NCT02948335|"~     Microorganisms that colonize hospital environments play an important role in the~     transmission of hospital acquired infections (HAI) and multi-drug resistant organisms.~     Previous studies examining microorganisms in the hospital environment have been limited by~     reliance on targeted culture-based methods resulting in potentially missed or unrecognized~     organisms. Evidence now suggests that using microbiome analysis offers an innovative~     strategy that may improve our understanding of HAI and how best to prevent them.~      This pilot longitudinal observational study aims to characterize the taxonomic composition~     of microbial communities on environmental surfaces and people in these environments prior to~     and following the introduction of patients, caregiver, and hospital staff to newly~     constructed inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This~     proposed study is uniquely characterized by evaluating the hospital environment of a~     pediatric immunocompromised oncology patient population that has not been studied in the~     past using advanced molecular techniques such as microbiome analysis.~      PRIMARY OBJECTIVE:~        -  To describe the pattern of microbial communities of the hospital environment before,~          during and after patient occupancy of a newly constructed hospital space.~      SECONDARY OBJECTIVES:~        -  To describe the similarity or difference of environment microbial communities to that~          of the humans occupying this environment in a newly occupied hospital space.~        -  To describe the pattern in environment microbial communities after each step of~          disinfection (manual cleaning with chemical disinfectant and Ultraviolet light~          disinfection machine) after patient discharge from the inpatient hospital environment.~        -  To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures~          and organism bioburden.~   "
8318|NCT02948322|"~     In this study, the investigators will evaluate the cardiac structure and function, focusing~     on the myocardial water content and interstitial fibrosis, in patients with active~     acromegaly in comparison with 1) healthy volunteers, 2) the same acromegalic patients that~     have received efficient therapy.~      The investigators hypothesize that the myocardial water content in acromegaly is increased~     as these patients present with sodium and water retention and that this myocardial water~     infiltration will improve with efficient treatment of the disease. They will thus assess~     using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2),~     reflecting water content in the myocardium.~   "
8319|NCT02948309|"~     In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in~     inoperable pancreatic cancer in order to evaluate effect on overall survival and~     health-related quality of life. Half of participants will take subcutaneous injections with~     mistletoe in addition to standard therapy (palliative chemotherapy or best supportive care);~     the other half will receive a placebo and standard therapy.~   "
8320|NCT02948296|"~     The goal of this study is to evaluate the efficacy of two promising brain stimulation~     treatment protocols designed to decrease the brain response to alcohol cues among heavy~     alcohol users.~   "
8321|NCT02948283|"~     This pilot clinical trial studies the side effects and best dose of metformin hydrochloride~     and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia~     that has returned after a period of improvement or has not responded to treatment. Metformin~     hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
8322|NCT02948270|"~     The interpersonal problems of adolescents with ADHD may be the most debilitating aspect of~     their psychopathologic behaviour. This being said, the investigators still do not have a~     clear understanding of why it is the case that individuals with ADHD have such impaired~     social and communicative competence. In particular, research has not identified whether the~     communicative difficulties stems from deficits in taking the perspective of a communicative~     partner, or in being able to make use of this information in a systematic way. This study~     will compare adolescents with ADHD to adolescents not diagnosed with ADHD and their~     performance on a number of social inference and communication tests. This study hypothesizes~     that persons with ADHD will not perform as effectively as control participants on the social~     inference and communication tests, and will evidence lower WM score. As well, this study~     hypothesizes that a working memory/cognitive load task will impede performance on certain~     social inference and communication tests to a greater extent in the ADHD population than in~     the control group.~   "
8323|NCT02948257|"~     The objective of the registry is to collect procedural outcomes data when the Cardiva~     VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the~     completion of ipsilateral peripheral interventional procedures performed through 5-7F~     introducer sheaths via an antegrade approach.~   "
8324|NCT02948244|"~     This multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare~     changes in strength-related motor function following treatment with creatine monohydrate to~     treatment with placebo, as measured by the Motor Function Measure, from baseline to 12~     weeks. Eligible subjects will undergo baseline assessments then will be randomised to either~     creatine monohydrate therapy or placebo for three months, followed by a six week wash-out~     period, then crossover to a further three months of therapy with either placebo or creatine.~     Subjects will undergo clinical assessments and study safety assessments at the beginning and~     end of each treatment period. The study will begin recruitment in early 2017.~   "
8325|NCT02948231|"~     The Mistral is an investigational device intended for percutaneous trans-catheter repair in~     high risk for surgery individuals suffering from functional Mitral Regurgitation.~      The device system is to be used only in accordance with the approved Investigational Plan on~     subjects who have signed an informed consent form. Device use is limited to the approved~     study investigators.~   "
8326|NCT02948218|"~     Knee osteoarthritis (KOA) is a major public health problem among the elderly and is~     associated with considerable disability. A recent analysis of data indicated that about 35%~     of women and men aged 60 years and above had radiographic knee OA.Despite the high~     prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a~     promising treatment option for knee OA due to the effectiveness of the pain relief and the~     rarity of adverse effects. In order to get some more reliable data to confirm acupuncture~     effectiveness on KOA, a long-term follow up interventional study will be started to confirm~     the effects of long term for acupuncture treatment.~   "
8327|NCT02948205|"~     This study intends to carry out a prospective, randomized controlled trial to compare the~     trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal~     laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify~     the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis~     for its application in infertility population.~   "
9217|NCT02936570|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
8328|NCT02948192|"~     Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks~     of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at~     enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be~     obtained at entry and at the time of delivery for metabolomic analysis. Participants will~     also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological~     specimens will then be analyzed for their microbiomial profile. This will then be correlated~     with the timing of their delivery as well as other comorbidities such as obesity,~     hypertension, and diabetes.~   "
8329|NCT02948179|"~     Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic hereditary~     kidney disease in humans. ADPKD may affect all the generations of the ADPKD family and the~     probability of ADPKD is 50% in the second generation for each gender. It has been confirmed~     that PKD1 and PKD2 are two pathogenic genes of ADPKD. Nowadays, the investigators have~     established an effective gene detection technology platform for PKD1/2 gene with long~     fragment PCR and next generation sequencing. First, the investigators performed genetic~     testing in patients with clinically diagnosed ADPKD and strong fertility desire, but afraid~     of hereditary risk. Using Preimplantation genetic diagnosis, including multiple annealing~     and looping-based amplification cycles amplification technique, the investigators~     successfully screened out healthy embryos by In Vitro Fertilization. Then the investigators~     transplanted embryos returned to the parent. When the baby is born, using umbilical cord~     blood gene detection, the investigators confirmed that the neonates do not inherit genetic~     defects form parents. The investigators have succeeded in one couple. The investigators~     design a multicenter clinical trial to confirm those procedures efficacy and safety.~   "
8330|NCT02948166|"~     Comparison of two methods for revascularization of the superficial femoral artery: remote~     endarterectomy vs. stenting of the superficial femoral artery cin patients with~     steno-occlusive lesion of the femoro-popliteal segment of TASC C, D~   "
8331|NCT02948153|"~     This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial~     hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2)~     mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of~     TLRs differ from non-mucus hypersecretory asthmatics patients.~   "
8332|NCT02948140|"~     The aim of the study is to estimate the contribution of abdominal imaging by magnetic~     resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic~     infarction associated to the atrial fibrillation in the cerebral infarction.~   "
8333|NCT02948127|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants and children 6 to 24 months of age.~      This study is a companion study to IMPAACT 2012.~   "
8334|NCT02948114|"~     The study is intended to evaluate the microorganisms found in infant stools when consuming~     study formulas containing prebiotics and/or probiotics compared to infants consuming~     mother's own breast milk.~   "
8335|NCT02948101|"~     The goal of this clinical research study is to learn about the effects of PD 0360324 on~     participant's immune system in participant's with epithelial ovarian, Fallopian tube, or~     primary peritoneal cancer and who have agreed to participate on Protocol PA13-0291. As part~     of this study, participant will also receive a type of standard chemotherapy called~     cyclophosphamide.~      The safety of PD 0360324 and cyclophosphamide will also be studied.~   "
8336|NCT02948088|"~     TGCT is a rare disease that is difficult to manage, surgical resection is the primary~     treatment currently available. To date no disease registry exists and there is little data~     available detailing the management of patients with diffuse TGCT, the burden of diffuse TGCT~     for patients (including pain, joint stiffness, swelling, reduced mobility and quality of~     life) or the economic impact of diffuse TGCT.~      This study aims to collect data by an observational disease registry involving no~     intervention to the patient or changes to investigators treatment decisions.~   "
8337|NCT02948075|"~     This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination~     with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced~     epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to~     first line platinum and Paclitaxel based chemotherapy.~      The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients~     with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or~     fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based~     chemotherapy, will be enrolled in the study.~   "
8338|NCT02948062|"~     The goal of this single institution study is to evaluate boys with adrenoleukodystrophy~     (ALD) diagnosed early in life, and to prospectively monitor them to determine parameters~     that will facilitate earlier detection of the childhood cerebral form of the disease. These~     at-risk subjects will be assessed yearly through travel to the University of Minnesota,~     where plasma and cerebral spinal fluid (CSF) biomarker studies, MRI based imaging and~     neuropsychological assessments will be performed at the University of Minnesota Masonic~     Children's Hospital and Clinics. The MRI and lumbar puncture to obtain CSF will be obtained~     under sedation. In addition, at intervening 6 months intervals information will be obtained~     remotely, including surveys and MRI's in their home location. Also at that time blood~     samples will be obtained locally and shipped to the University of Minnesota for study. There~     is no therapeutic intent in this study.~   "
8339|NCT02948049|"~     This study is a single site, prospective, observational trial utilizing a wrist-worn~     accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.~   "
8340|NCT02948036|"~     Specific Aim 1: Finalize development of the closed-loop strategy in the Moodify application.~      Specific Aim 2: Evaluate the acceptability and feasibility of the Moodify application with~     the target population to prepare for a large-scale efficacy trial.~   "
8341|NCT02948023|"~     This is a investigative initiated, comparative pilot clinical trial to ascertain the safety~     of application of ex-vivo cultivated limbal stem cells in human eyes for treating different~     superficial corneal pathologies. Pre-clinical work in murine models have already~     demonstrated efficacy of this technique in curing murine corneal pathologies.~   "
8342|NCT02948010|"~     The purpose of this trial is to assess device performance against participants in an~     overnight study to ensure the product meets user and clinical requirements~   "
8344|NCT02947984|"~     The purpose of this study is to determine the best radiation dose for participants with~     meningioma that has grown back after previous surgery, or which the surgeon has been unable~     to remove completely. This research study is designed to determine whether a higher dose of~     radiation will decrease the likelihood that the tumor will grow back, compared to the~     probability of re-growth that occurs after standard radiation doses.~   "
8345|NCT02947971|"~     The goal of this research is to test a distal scanning capsule and a compact redesigned~     version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety~     and feasibility in preparation for its use in a multicenter clinical trial.~   "
8346|NCT02947958|"~     To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference~     between tertiary and primary care for patients with stable benign prostatic hyperplasia~     (BPH) symptoms.~   "
8347|NCT02947945|"~     Reslizumab is a type of medicine called a monoclonal antibody that is made in the research~     clinic; it works by blocking a specific protein in the body called interleukin-5. The study~     medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is~     considered an experimental drug in this study.~   "
8348|NCT02947932|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. However, the risk~     factors of PEP is not fully clear. Additionally, the complication of NSAID use lead to some~     serious physical problem bleeding. Therefore, the exclusive criteria for limiting the NSAID~     use is including allergy， gastrointestinal haemorrhage ，presence of coagulopathy or received~     anticoagulation therapy. Previous study showed that another natural compound, resveratrol,~     owns similar biological effect with NSAID. Firstly, it could inhibit the inflammatory~     response on in vivo model through inhibition of COX and IL-6 etc. Secondly, it could not~     influence the level of platelet and coagulation, which means safer than NSAID. Thirdly,~     numerous studies showed that resveratrol could effectively the progression of severe acute~     pancreatitis. According to data, we design the project. The purpose of this study is to~     determine whether oral resveratrol pre-ERCP is effective on control of Post-ERCP~     pancreatitis.~   "
8349|NCT02947919|"~     Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing~     surgery, having a great physiological and emotional impact on children in both the short and~     long term. There are many reports on the use of music therapy in the perioperative period as~     a complementary technique in the preoperative stress and anxiety management. However, there~     are no assessments of the effect of this intervention on the physiological variables, such~     as salivary cortisol.~   "
8350|NCT02947906|"~     Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be~     participants of the study.Participants with multiple sclerosis will evaluate with the~     following assessment tools: Modified Ashworth scale will use to evaluation of severity of~     plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic~     pedobarography.~   "
8351|NCT02947893|"~     The investigators hypothesize that Nilotinib will be safe in individuals with mild to~     moderate AD. Specifically, investigators hypothesize that low daily oral doses of Nilotinib~     will lead to CSF penetration, CNS Abl inhibition, and stabilization of CSF total Tau and~     p-Tau231/181 and Abeta42/40 levels. The investigators hypothesize that Nilotinib will~     decrease brain load of amyloid using amyloid positron emission tomography (PET). The~     investigators also predict that Nilotinib will reduce CSF markers of cell death, including~     neuron specific enolase (NSE) and S100B.~   "
8352|NCT02947880|"~     During a previous therapeutic trial, investigators showed that the bumetanide improved~     significantly autism. This trial showed that a therapeutic response was obtained in 75% of~     cases.~      These first results were reinforced by a study led with adult patients for whom the eye~     tracking measurements as well as the functional MRI showed a diminution of the response time~     and a modification (amplification) of the cerebral response during an emotions recognition~     test.~      Finally, investigators confirmed the physiological mechanism behind the action of the~     bumetanide in a study in two mouse models of autism.~   "
8353|NCT02947867|"~     A prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre phase~     II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein~     Occlusion to Prevent Neovascular Glaucoma - the STRONG Study~   "
8354|NCT02947854|"~     Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in~     novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance~     the effects of other drugs in a site-specific, light-directed manner and is used to~     re-localise endocytosed molecules from endosomes to cytosol. This research study is~     evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens~     for safety and induction of immune responses.~   "
8355|NCT02947841|"~     The purpose of this study is to investigate the hypothesis that alternating DBS parameters~     on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared~     with non-alternating stimulation. The primary endpoint will be preserved tremor control with~     the alternating group compared with standard treatment using the Tremor Research Group~     Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved~     activities of daily living measures as well as preserved tremor control as quantified by~     motion sensor data.~      This study has one primary aim: To determine if alternating DBS stimulation parameters on a~     weekly basis will be superior at preserving tremor control compared with usual stimulation~     (non-alternating stimulation) in ET patients with VIM DBS.~   "
8356|NCT02947828|"~     This is a population-based study of type 2 diabetes patients with and without neuropathy~     recruited from the Danish National Type 2 Diabetes cohort (DD2).~      Perspective: The study will identify risk factors for developing diabetic polyneuropathy and~     painful diabetic polyneuropathy and provide information on the underlying mechanisms, which~     will hopefully contribute to significant improvements in the treatment and prevention of~     diabetic polyneuropathy in future.~   "
8357|NCT02947815|"~     The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of~     essential blepharospasm~   "
8839|NCT02941510|"~     A randomized, double-blinded study administering budesonide, a medication to reduce~     inflammation in the lungs, to healthy volunteers to examine effects on altitude illness~     prevention by spending 18 hours overnight at 14,000 ft elevation.~   "
8358|NCT02947802|"~     This is an online survey assessing consumer support for different labeling policies related~     to sugar sweetened beverages. The investigators will present consumers with three labels~     that are being considered for sugar sweetened beverages: a calorie label, a text warning~     label that says Warning drinking beverages with added sugar(s) can lead to health problems~     like obesity, diabetes and tooth decay and a graphic warning label that includes graphic~     images to correspond with each of the health problems listed with the text warning. The~     investigators will ask participants their support for each label. The investigators will~     also see if support for the labels change after learning of the effectiveness of these~     labels. The investigators will share the results of a recent field study that suggested~     calorie and textual warning labels had no influence on the purchasing of sugar sweetened~     beverages while the graphic label decreased purchasing by 11 percent.~   "
8359|NCT02947789|"~     Surgery has risk of morbidity and mortality. Risk factors include: patient factors; surgical~     factors; and anesthetic factors. The risk is much higher in emergency cases. The study of~     relevant risk factors can lead to improvement in patient management and reduction in~     mortality.~   "
8360|NCT02947776|"~     Aims: This exploratory trial will:~        1. Explore the feasibility of a definitive/phase III RCT on clinical and~          cost-effectiveness of peer-befriending for people with aphasia post-stroke.~        2. Investigate psychological and social wellbeing outcomes of participants, significant~          others, and peer befrienders.~        3. Explore the feasibility of a full economic evaluation of usual care + peer befriending~          versus usual care control.~      Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care +~     peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver~     on four work packages: development phase; RCT; qualitative study; economic evaluation.~     Participants (n=60) will be assessed three times up to 10 months post-randomisation.~      Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion~     screened who meet criteria; proportion who consent; rate of consent); participant,~     significant other, peer befriender views on acceptability of procedures (qualitative study);~     number of missing/incomplete data on outcome measures; attrition rate at follow-up;~     potential value of conducting main trial using value of information analysis (economic~     evaluation); description of usual care; treatment fidelity of peer-befriending.~     Patient-reported outcomes will include mood, wellbeing, communication and social~     participation.~      Benefits: Peer befriending may help avert some of the serious psychological consequences of~     stroke, and prevent the need for more complex and costly psychological therapies.~   "
8361|NCT02947763|"~     Healing rate after single visit or multiple visit endodontic treatment using triple paste~     intracanal medicament will be assessed both clinically and radio-graphically for follow-up~     period up to one year~   "
8362|NCT02947750|"~     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have~     poor exercise capacity and to explore what causes an increase in blood pressure during~     exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to~     dilate). This study will also test whether or not regular exercise on a bicycle and/or~     treatment with 6R-BH4 (Kuvan) pills improves these measures during exercise. 6R-BH4 is~     currently FDA-approved for use in patients with certain forms of a disease called~     phenylketonuria, but it is not currently FDA approved for blood pressure or exercise~     capacity in people with CKD.~   "
8363|NCT02947737|"~     The purpose of this study is to compare the effectiveness of applying amniotic membrane~     dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This~     study will enroll ten participants who undergoing a split thickness skin graft procedure~     with two or more donor sites. The amniotic membrane will be applied to one donor site and a~     dressing of xeroform and gentamicin will be applied to another other donor site. Each~     participant will receive both types of dressing and will serve as their own control.~     Postoperative follow up will follow standard of care, regardless of the dressing type.~     Dressings will be removed on postoperative day 4 and participants will return to be~     re-examined one week after being discharged from the hospital.~   "
8364|NCT02947724|"~     Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of~     ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants~     were randomized into 4 groups; group A (drainage only) in which 50 patients underwent~     laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B~     (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma~     cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic~     fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel~     inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent~     laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of~     Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months~     for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of~     endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian~     cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian~     reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the~     laparoscopy.~   "
8365|NCT02947711|"~     This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to~     evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P~     glycoprotein [Pgp] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in~     healthy participants.~   "
8366|NCT02947698|"~     Increased in-hospital mortality associated with weekend admission has been reported for many~     acute conditions, but no study has investigated weekend effect for acute kidney injury~     requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D~     patients admitted on weekday versus weekend and assessed factors associated with increased~     mortality.~   "
8367|NCT02947685|"~     The primary objective of this study is to demonstrate that the combination of palbociclib~     with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus~     endocrine therapy alone in improving the outcomes of subjects with hormone~     receptor-positive, HER2+ metastatic breast cancer.~   "
8368|NCT02947672|"~     Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of~     postoperative nausea and vomiting following Laparoscopic gynecological surgeries.~   "
9218|NCT02936557|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
8369|NCT02947659|"~     [Purpose] To investigate the prevalence of musculoskeletal disorders among healthy students~     of Ahlia University and to determine the relationship between the prevalence of~     musculoskeletal disorders and academic stressors and body mass index. [Subjects and~     Methods]: Self-administered questionnaires were distributed to 94 students aged 18-26 years~     who were enrolled at various Ahlia University colleges and met other inclusion criteria. The~     students responded to the standardized Nordic musculoskeletal questionnaire and the modified~     College Student Stress Inventory regarding musculoskeletal symptoms and academic stressors.~     Height and weight measurements were also obtained to determine body mass index.~      Keywords: Body mass index, Academic stress, Musculoskeletal disorders~   "
8370|NCT02947646|"~     This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.~     BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain~     subject feedback, assess device performance; and ascertain potential harm in healthy adult~     volunteers.~   "
8371|NCT02947633|"~     The purpose of this research is to compare the effect of single-injection sciatic PNB to~     continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain~     scores, pain medication use, and unplanned hospital admission due to poor pain control, 2)~     active knee flexion, and 3) patient satisfaction with pain control following ACL~     reconstruction with a hamstring autograft. The results of this research have the potential~     to positively impact pain control for the adolescent population undergoing this surgical~     procedure and foster responsible utilization of limited resources.~   "
8372|NCT02947620|"~     A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the~     safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and~     dyslipidemia.~   "
8373|NCT02947607|"~     The purpose of this study is the investigation of new host-microbiome interactions promoting~     adenoma formation and adenocarcinoma progression. For that purpose, the investigators will~     collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or~     surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and~     medical history will be collected. Sample analysis will involve simultaneous~     characterization of host and microbiota genomic and transcriptomic components.~   "
8374|NCT02947594|"~     Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications~     resulting from administration of parenteral nutrition in neonates. Excess intravenous intake~     of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major~     contributing factor. To date, no information is available on plasma phytosterols half-lives~     in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study,~     plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with~     PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN~     administration and also after the stop of intravenous lipid infusion. Plasma phytosterols~     half-lives will be calculated from the monoexponential decay curves. Blood samples will be~     weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis~     or gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected~     in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be~     stored in pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be~     done using 5-alpha-cholestane as internal standard.~   "
8375|NCT02947581|"~     Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological~     disease in most of the world. When parasites locate in the cavities around the brain~     (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal~     presentation. Current treatment regimens for SANCC have quite limited efficacy. The~     investigators propose to compare the current standard of care (a single antiparasitic drug,~     albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding~     praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in~     Ecuador, and one in Brasil.~   "
8376|NCT02947568|"~     The present study investigates relationship between non-alcoholic fatty liver disease and~     its risk factors, such as genetic background and diseases, such as chronic kidney disease~     and diabetes mellitus.~   "
8377|NCT02947555|"~     The rate of lens autofluorescence will be compared in diabetic and non diabetic patients~     with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk~     of cardiovascular diseases.~   "
8378|NCT02947542|"~     There is no evidence from prospective randomized clinical trials regarding the performance~     of conventional versus one-catheter-strategy for invasive coronary angiography over the~     radial access.~      The aim of the present trial was to evaluate the efficacy and safety of the one-catheter~     concept with use of the BLK and Tiger catheter compared to the standard Judkins catheter in~     diagnostic coronary angiography via transradial access. Patients with stable angina pectoris~     will be randomly assigned to coronary angiography performed with the BLK, Tiger and Judkins~     catheter. The primary endpoint is coronary angiography duration.~   "
8379|NCT02947529|"~     BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative~     blood loss for various orthopaedic procedures including but not limited to total hip~     arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in~     2013 showed that patients who received TXA showed a significant reduction in post-operative~     transfusion (20.1% to 7.7%). The procedures we will be evaluating are the intramedullary~     nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar~     to the total hip or knee replacement in that they can result in significant blood loss that~     requires a post operative transfusion.~      STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative~     transfusion for acute hip fractures repaired with the following two methods, intramedullary~     nailing for intertrochanteric fracture and hemiarthroplasty.~      METHODS: The model for the study is a prospective randomized control trial. Patients will be~     placed in one of two arms of the study after passing our inclusion criteria. The arms will~     be for either the intramedullary nailing for intertrochanteric fracture or for~     hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those~     not receiving TXA. The patients in each category will have standard post-operative care and~     laboratory testing. We will record the patients in either arm of the study, whether it be no~     TXA or TXA, who require post-operative transfusion within 1 week of the operation.~   "
9219|NCT02936544|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
8380|NCT02947516|"~     There are several ways to perform liver biopsies, including the percutaneous route~     (historical gold standard) and via endoscopic ultrasound (EUS) guidance. The primary aim of~     this study is to prospectively compare patients undergoing EUS-guided liver biopsies to~     patients undergoing percutaneous biopsy. The investigators hypothesize that (1) patients who~     are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain~     in the 48 hours following the procedure, and (2) will have comparable histologic yield to a~     2:1 matched cohort of patients undergoing percutaneous liver biopsies.~   "
8381|NCT02947503|"~     One approach to prevent the rising burden of diabetes is to address the issue of gestational~     diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in~     specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM~     increases the risks of complications during pregnancy, at delivery and on the longer term,~     like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin~     added to diet as the standard care for GDM has disadvantages for mother (maintenance of~     hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia,~     hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer~     targeting the cause of GDM, may have essential benefits, as suggested by observational~     studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still~     lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the~     hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet~     and lifestyle improves clinically relevant pregnancy outcomes in mother and child during~     pregnancy, at delivery and on the longer term - up to 20 years after birth.~   "
8382|NCT02947490|"~     This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the~     emergency TIA clinics and the acute stroke services at the Norfolk & Norwich University~     Hospital) who require anti-hypertensive therapy to examine the clinical and cost~     effectiveness of self-monitoring and self management of Blood Pressure compared to self~     monitoring alone and treatment as usual.~   "
8383|NCT02947477|"~     The proposed study will develop and pilot a fourteen-day assessment tailored for the~     high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses~     ecological measurement assessment (EMA), which solicits real-time user feedback at various~     time points across a series of days or weeks.~   "
8384|NCT02947464|"~     Cure rate os pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment~     adenotonsillectomy is 50-80 %. Treatment alternatives are scarce, poorly effective and based~     up on low scientific evidence. This means one out of five patients will remain exposed to~     the well-known neurocognitive, behavioral and quality of live adverse effects of disease.~      Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion,~     has recently shown promising results in the treatment of pediatric OSAS based upon its~     effect on craniofacial and upper airway growth, usually limited in this patients.~      The investigators propose a randomized, prospective, controlled trial in patients with~     Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the~     treatment success rate avoiding morbimortality associated to disease persistence during~     childhood and development during adult life.~   "
8385|NCT02947451|"~     Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise~     interventions in their management. This study aims to investigate the immediate effects of~     manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best~     interventions favors reducing spending on health and safety for the patient.~   "
8386|NCT02947438|"~     This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO®~     and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The~     targeted population is anaemia patients with end-stage chronic renal disease who previously~     received epoetin treatment and on haemodialysis.~   "
8387|NCT02947425|"~     This is a prospectively registered database of patients with early breast cancer who will be~     treated with radiotherapy during surgery. More than 2000 women have already received this~     treatment in clinical trials. This study will monitor the health status of women who receive~     this treatment outside of a clinical trial, especially those who might not have been~     eligible for the original clinical trials. The aim is to confirm the long-term effectiveness~     and safety of the technique.~   "
8388|NCT02947412|"~     Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it~     is gaining popularity as a single procedure. Long term data is scarce. In this retrospective~     study long term follow-up in relation to weight loss, comorbidities, re-do and revisional~     surgery is getting analyzed.~   "
8389|NCT02947399|"~     This research study is to compare the radiopharmacokinetics of I-124 to the~     radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after~     thyroid hormone withdrawal. I-131 is routinely used for imaging and dosimetry for patients~     with well-differentiated thyroid cancer. In this study, I-124 is administered orally in~     capsular form, and the radiopharmacokinetics of I-124 is compared with I-131. I-124 is~     another isotope of iodine, which is cyclotron-produced. I-124 has multiple advantages:~        -  Ideal Half-Life (4.2 days) for delayed imaging.~        -  High resolution tomographic imaging.~        -  Feasibility of quantitating lesion uptake.~        -  Potential of dosimetry for the planning of radioiodine therapy.~      Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry,~     which is planned as part of routine clinical care. I-124 dosimetry is composed of three~     parts: (1) the administration of I-124, (2) imaging, and (3) drawing blood samples.~      Patients will start 3-5 weeks of thyroid hormone withdrawal. This is similar to the~     procedure for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131~     except I-124 decays in a different way to emit a positron so that the PET scanner can be~     used for imaging. I-124 is given in the form of one or several capsules, which are taken by~     mouth. This is also similar to I-131. Third, PET/CT imaging is done for approximately 30~     minutes to one hour on five consecutive days. Radiation from PET/CT scan is far less than~     what they receive from a diagnostic CT scan. For the fourth part, a technologist will draw~     about 5 cc from the forearm on each of the five consecutive days. This is also similar to~     I-131.~      Initially, all patients will be randomized to one of two study groups. The first group will~     have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second~     group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.~      The risk of this study is considered very low, and the potential benefits to the patient are~     considered very high.~   "
8390|NCT02947386|"~     This phase I/II trial studies the best dose and side effects of nimotuzumab when giving~     together with nivolumab and to see how well they work in treating patients with non-small~     cell lung cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may~     block tumor growth in different ways by targeting certain cells.~   "
8391|NCT02947373|"~     This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13~     imaging in children with brain tumors.~   "
8392|NCT02947360|"~     Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk~     stratify patients with chest pain in the emergency department (ED).~      Background and Rationale: Traditional risk assessment focuses on characteristics of the~     pain, known Coronary Artery Disease (CAD), risk factors, electrocardiogram (ECG), and blood~     tests to identify active ischemia. Identifying clinically significant CAD remains one of the~     most challenging tasks in the ED. Current clinical decision rules err on the side of over~     investigation and admission. To address this limitation, the Investigators have developed a~     point-of-care carotid ultrasound test predictive of CAD. The Investigators have shown that~     carotid plaque is strongly associated with significant angiographic CAD in a population~     referred for angiogram.~      Research Aims:~      Primary - To determine the association between carotid plaque measured by a dedicated~     sonographer and 30-day major adverse cardiac events (MACE), including MI, reperfusion, or~     death in patients presenting to the ED with suspected cardiac ischemia.~      Secondary - To determine the agreement sonographer and emergency physician FOVUS results.~      Methodology: The Investigators propose a prospective cohort study to assess the prognostic~     value of a novel point-of-care carotid ultrasound plaque quantification protocol in the ED~     of Kingston General Hospital. We will enroll 500 consecutive patients presenting with a~     chief complaint of chest pain prompting at least one 12-lead ECG and troponin measurement.~     Patients will undergo carotid scan by a dedicated sonographer and emergency physician.~     Patients will be followed for MACE for 30 days. Those performing scans will be blinded to~     clinician's impression and care plans while clinicians will be blinded to FOVUS findings.~     The primary analysis will involve determination of the sensitivity, sensitivity, positive~     predictive value, negative predictive value and likelihood ratios associated with FOVUS for~     30-day MACE.~      Expected Outcomes: The study will provide evidence to determine whether FOVUS may be a~     useful prognostic tool for emergency physicians assessing patients with suspected ischemic~     chest pain. The secondary analysis will provide evidence to determine whether emergency~     physicians can be trained to measure carotid plaque height accurately when compared to the~     gold standard ultrasonographer measurement.~      Significance: If FOVUS can reliably identify very low risk patients, implementation of this~     novel tool could reduce ED length of stay, monitoring, and overcrowding.~   "
8393|NCT02947347|"~     The purpose of this study is to evaluate whether the addition of ibrutinib will result in~     prolongation of progression-free survival (PFS) when compared with rituximab alone in~     treatment naïve subjects with follicular lymphoma.~   "
8394|NCT02947334|"~     This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel~     group, multi-center clinical trial designed to compare the efficacy and safety of~     bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary~     hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will~     enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including~     China mainland); of which approximately 600 subjects will be from sites in China. Subjects~     will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.~   "
8395|NCT02947321|"~     Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and~     functional status in non-surgical patients with knee osteoarthritis as well as the high~     prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed~     to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic~     postoperative pain as well as functional status in patients undergoing TKA. Patients will be~     randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control~     group (RFA needles placed in proper location without effective neurotomy).~   "
8396|NCT02947308|"~     This study will examine longitudinal brain development in young adolescent girls with a~     history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the~     the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a~     cognitive battery.~   "
8397|NCT02947295|"~     To develop a rapid, sensitive, and inexpensive diagnostic method, as well as more~     efficacious vaccine, for countries where typhoid fever remains a major public health burden.~   "
8398|NCT02947282|"~     The pelvic floor is composed of muscles and connective tissue which acts to provide support~     for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor~     dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of~     increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single~     workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic~     floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase~     satisfaction with their delivery experience, and change participants preferences and~     thoughts surrounding various modes of delivery.~   "
8399|NCT02947269|"~     Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after~     abdominal surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting,~     are unable to open their bowels and have a prolonged hospital stay. Research at ADHB shows~     that 25% of patients will have a prolonged POI after elective bowel resection, which makes~     it the most common major complication after colorectal surgery. Clinicians currently lack a~     definitive medication to prevent or treat POI, which means POI causes patients ongoing~     morbidity and places a significant drain on healthcare resources. Serotonin plays an~     important role in gut motility. Evidence suggests that serotonin agonists, such as~     prucalopride, increase gut transit and may have anti-inflammatory properties. The hypothesis~     of this study is that Prucalopride given pre-operatively and continued post-operatively in~     patients having an elective bowel resection will improve gut function recovery after surgery~     and reduce POI.~      The investigators' proposed study is a double-blinded randomised controlled trial of~     prucalopride compared to an identical placebo tablet, in patients having an elective bowel~     resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride~     or placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days.~     The primary endpoint will be return to bowel function defined by the time to tolerate a~     solid diet and pass stool. In addition, the investigators plan to assess postoperative~     gastric emptying rates using the safe and non-invasive carbon breath test method. This will~     allow the investigators to determine the effects of prucalopride on the stomach, and support~     its role as a gastric prokinetic.~   "
8400|NCT02947256|"~     Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared~     to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred~     chole-cystohepatic (Calot's) triangle.~   "
8423|NCT02946970|"~     The investigators aim to study the brain mechanisms underlying the effect of subliminal (not~     consciously perceived) intragastric administration of bitter tastants on hunger and food~     intake, which was previously found. The investigators will assess brain activation patterns~     after an acute intragastric administration of Quinine-hydrochloride versus saline on two~     different test days, and will simultaneously assess a putative role of altered gut peptide~     release in these effects. The hypothesis is that intragastric infusion of a bitter agonist~     will decrease the activity in homeostatic and hedonic brain regions and that this effect is~     mediated by gut peptide release.~   "
8854|NCT02941315|"~     The investigators aimed to use CMR technique in helping diagnose the etiology of unknown~     cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the~     extent of myocardial impairment.~   "
8401|NCT02947243|"~     Children with burn injuries experience severe pain intensity during medical procedures~     despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain~     management recommend the combination of non-pharmacological and pharmacological~     interventions to enhance pain management and decrease the numerous side effects of~     analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological~     method as it engages multiple senses and allows interactions with a virtual world. Oculus~     Rift ® is a new technology in VR that provides more immersiveness, at a relatively low cost,~     and could probably improve the management of pain and anxiety in burn care. It also has the~     potential, with appropriate custom software designed for burn pediatric patients, to reduce~     the cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the~     investigators, none of the pediatric hospitals across Canada have tested VR as a method of~     pain and anxiety management in children with burn injuries. Overall hypotheses: VR~     distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as~     well as a less traumatizing hospital experience, while promoting a more humanistic care~     environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic~     interventions administered to these children. The expected results will have a direct effect~     on physical (pain) and psychological (anxiety, pain memories) health of the child. In~     addition, clinical implications may include other indicators of quality of care and economic~     benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids~     and anxiolytic drugs administered.~   "
8402|NCT02947230|"~     The McMaster Optimal Aging Portal (the Portal) was launched in 2014 to increase public~     access to trustworthy health information. The Portal helps readers to access evidence-based~     resources; identify trustworthy messages; and understand scientific findings. Now the~     investigators want to know whether using the Portal changes what people know and do to stay~     healthy and mobile.~      This project will help us to:~        1. Understand how middle aged and older adults (age 40+) use the Portal to obtain~          information about maintaining and improving mobility~        2. Evaluate whether use of the Portal results in a change in knowledge about maintaining~          and improving mobility, or change in lifestyle behaviours that may help maintain or~          improve mobility with age.~   "
8403|NCT02947217|"~     In this study the investigators propose a randomized controlled trial to evaluate the effect~     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro~     fertilization.~   "
8404|NCT02947204|"~     The investigators will conduct a study around the best way to monitor infants hospitalized~     with bronchiolitis, the most common lung infection and a leading reason for hospitalization~     in infants. Infants with bronchiolitis have breathing difficulties and are provided~     supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding~     how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor~     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours~     (intermittent oxygen monitoring). Research has suggested that placing infants with~     bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants~     staying longer in hospital. However, due to the lack of high quality research, its unclear~     which strategy is best and practice varies. The objective of this study is to conduct high~     quality research across hospitals to determine whether intermittent compared to continuous~     oxygen monitoring will reduce the length of hospital stay in infants hospitalized with~     bronchiolitis. The investigators will also compare safety and cost. The results of this~     study will inform bronchiolitis practice standards and the best use of health care~     resources.~   "
8405|NCT02947191|"~     The purpose of this study is to assess the safety and efficacy of collagen membrane combined~     with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in~     patients with chronic nasal septum perforation.~   "
8406|NCT02947178|"~     Femoroacetabular impingement is a pathologic process within the hip joint that results from~     a mechanical discord between the femoral head and neck and the acetabulum that results in~     chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2~     Historically an open surgical hip dislocation was performed to treat patients with this~     condition, however with recent advances in arthroscopy, patients more commonly now undergo~     arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide~     peri-operative analgesia included intraarticular or portal analgesic injections. More~     recently, regional anesthesia techniques are being employed to provide more reliable and~     longer lasting post-operative pain control.3, 4 Currently, there are several local~     anesthetics available for regional anesthesia. However, they only provide an average of~     12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a~     local anesthetic that has been used for many years by multiple routes to control~     post-operative pain. A new formulation of the medication prolongs the release of the active~     ingredient after a single injection and has been shown to result in up to 72 hours of~     post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any~     studies in the literature comparing a historical control local anesthetic to this new~     formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration~     blockade to provide post operative pain control following hip arthroscopy.~   "
8407|NCT02947165|"~     To characterize the safety and tolerability of NIS793 as single agent and in combination~     with PDR001 and to identify recommended doses for future studies.~   "
8408|NCT02947152|"~     A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and~     renal cell carcinoma~   "
8409|NCT02945202|"~     This study investigates the effects of trabeculectomy and combined phacoemulsification plus~     trabeculectomy on corneal astigmatism.~   "
8410|NCT02947139|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20161 in Healthy Volunteers~   "
8424|NCT02946957|"~     Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also~     experience significant sleep disturbance. This randomized trial will determine whether a~     telephone-based cognitive behavioral treatment targeting insomnia in older adults with~     chronic severe OA-related insomnia and pain results in substantially greater reductions in~     insomnia severity and in related improvements in pain, fatigue, mood, quality of life and~     healthcare costs compared to telephone-delivered education (attention control) about~     insomnia. The trial will test an intervention that if demonstrated to have long term~     efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.~   "
8411|NCT02947126|"~     When developing new medications for lung diseases like cystic fibrosis, we depend on lab~     experiments using cells from the airways, physiology studies of how the lungs change when a~     drug is given and clinical studies that determine how drugs affect overall health. We want~     to develop computer models that will let us link the results of these different kinds of~     studies so that we can better predict how patients will respond to drugs by just doing lab~     studies on cell samples from their noses. This will allow us to develop medications more~     rapidly for all patients and also to personalize treatments for individual patients as well.~     In order to develop these computer models we will perform a series of tests on patients who~     have Cystic Fibrosis (CF). This will include sampling cells from the nose and measuring~     their lung physiology using a combination of different imaging, breathing, and other studies~     performed both before and after they take a therapy. We will perform similar tests on people~     who do not have CF, and also studies on the parents of our CF patients who carry a single CF~     gene because this will provide us with information on how specific genes might affect CF~     lung disease.~   "
8412|NCT02947113|"~     Concurrent chemoradiotherapy is the standard treatment for locally advanced non-small cell~     lung carcinoma (NSCLC). Different chemotherapy and radiation regimens have been advocated~     but in general, cisplatin-doublets are deemed standard of care. Decreasing the overall~     treatment time of irradiation by hypofractionation is thought to increase the efficacy.~     Extensive experience is available on the combination of daily-dose cisplatin in combination~     with hypofractionated radiotherapy. However, no data is available on the safety of cisplatin~     doublets and hypofractionated radiotherapy~   "
8413|NCT02947100|"~     The purpose of this study is to determine the safety of a new formulation of the omega-3~     fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether~     it decreases inflammation and inflammatory pain in children and young adults with Sickle~     Cell Disease.~   "
8414|NCT02947087|"~     Primary objective: To describe and compare the safety and efficacy of treatment with AAT in~     chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation~     (TP-IAT).~   "
8415|NCT02947074|"~     Rationale: Healthcare professionals face a growing burden of responsibilities and work~     overload which may cause psychological suffering expressed by burnout, depression and other~     negative psychological variables. Personal behavioral strategies may facilitate the coping~     process. To maintain these positive characteristics, it is necessary that one decouples from~     automatic thoughts, habits and patterns of unhealthy behaviors, leading to behavioral and~     physiological regulation, through mindfulness techniques. More specifically, Yoga is an~     ancient Indian philosophical and practical system and its ultimate goal is to calm the human~     mind, and increase vital capabilities. In addition to the ethical precepts of Yoga,~     practices involve asanas (postures), pranayama (breathing exercises) and dhyana~     (meditation). Many studies have shown the positive effects of Yoga and meditation on~     psychometric variables, however, there are few which address the effectiveness of Yoga on~     improving psychometric variables of health care professionals. Thus, aiming to reduce the~     symptoms that health care professionals experience when they are under burnout, this study~     intends to use Yoga meditation, which may enable the professional to experience decoupling~     of harmful feelings, improving, firstly, one's own inner self-relationship and therefore,~     with patients and their families.~      Objective: To investigate the effects of a 8-week yoga meditation program on psychometric~     and physiological variables of Pediatrics health professionals.~      Methods: randomized controlled clinical trial. Participants: 60 health professionals from~     the Pediatrics Department of a tertiary hospital from Federal University of São Paulo~     (UNIFESP) will be randomized to meditation or control (waiting list) groups. Subjects of the~     meditation groups will have 2 30 min classes a week.~      Evaluations: Psychometric and physiological variables will be accessed at study entry~     (baseline) and after its completion (8-weeks).~      Statistical Analysis: mixed general linear model (intervenient factors: groups - meditation~     vs. control and moment - baseline vs. 8-weeks). Significance accepted with p<0.05.~   "
8416|NCT02947061|"~     To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With~     Advanced Breast Cancer first-line treatment~   "
8417|NCT02947048|"~     This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively~     randomized, placebo controlled patients and 5 open label patients at either 100 tid or 200~     tid dosing for 28 days. The open label patients will be assessed for the purpose of~     understanding PK/PD and to determine if there are any EKG changes associated with the~     administration of L1-79. Additional safety information will be provided by the 30 patients~     randomized 2:1 active:placebo.~   "
8418|NCT02947035|"~     The research study consists of the participant agreeing to 1) the use of preoperative~     molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective~     collection of medical record data related to treatment of thyroid cancer.~   "
8419|NCT02947022|"~     Purpose: There are two goals we have for this prospective single arm study; to see an~     increase in the amount of gadolinium in 24 hour urine collection following each infusion~     treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium~     deposition disease (GDD) symptoms.~      Participants: Twenty (20) patients who are suffering from gadolinium deposition disease~     (GDD)~      Procedures: Over a series of three (3) treatment time-points patients will be treated with~     IV Ca-DTPA on day one, and Zn-DTPA on day two.~   "
8420|NCT02947009|"~     Exercise-induced paradoxical vocal fold motion disorder (E-PVFMD) - which severely impacts~     the lives of up to 1 million adolescents in the U.S. annually - is under- or mis-diagnosed~     in as many as 80% of cases, leading to ineffective, protracted periods of management.~     Additionally, what makes those with the condition different from those at risk for the~     condition (e.g., playing sports/engaging in athletic activity within a competitive athletic~     environment) is unclear. The goals of this proposed study are to address this diagnostic~     challenge by (1) pursuing a previously published preliminary taxonomic algorithm for the~     clinical identification and classification of EPVFMD, and by (2) elucidating potential~     underlying mechanisms driving this clinical presentation. Study outcomes will improve~     sensitivity and specificity of diagnosis protocols for PVFMD, thereby reducing prevalence of~     misdiagnosis and improving clinical management in individuals with this disorder in the~     future. Outcomes will also be used to create preventative care measures for adolescents at~     risk for the condition.~   "
8421|NCT02946996|"~     The purpose of this study is to look at the effects that the study drugs (metformin and OPC)~     have on AGE levels in patients with prostate cancer.~   "
8422|NCT02946983|"~     The investigators will test whether a subliminal, intragastric dose of fructose is able to~     influence the emotional state at the behavioural and neural level, as has been previously~     shown for fatty acids. They will also examine the potential involvement of gut peptide~     release. Based on previous research using fatty acids, an attenuating effect of fructose~     compared to placebo on the induced negative emotional state is hypothesized at the~     self-report as well as the brain level.~   "
8427|NCT02946918|"~     In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than~     the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and~     more unpredictable TSH (thyroid stimulating hormone) levels.~      The investigators therefore hypothesize that following thyroidectomy for Stage I/II~     differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more~     predictable TSH results and in turn require fewer dose adjustments to achieve optimal~     hormone levels in the postoperative period.~      The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules~     to tablet form for TSH suppression following thyroidectomy for presumed stage I/II~     differentiated thyroid cancer.~   "
8428|NCT02946905|"~     Cognitive impairment is a poorly understood, serious, and emerging complication for adult~     patients with sickle cell disease. Because there is extensive microvascular damage from~     oxidative damage in sickle cell disease, the investigators hypothesize that this is also~     present in the cerebral microvasculature to cause cognitive impairment. The investigators~     plan to test this by correlating markers of inflammation and oxidative damage with cognitive~     performance and 7 Tesla brain MRI microvascular findings in these patients, with the long~     term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle~     cell disease.~   "
8429|NCT02946892|"~     This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart~     operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests~     will be performed at the end of each 12 week period.~   "
8430|NCT02946879|"~     This study is a longer-term follow-up study for patients who have been administered~     AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation~     trial in adults and children with retinal dystrophy associated with defects in RPE65.~      The study is designed to collect data on longer-term safety and efficacy at 9-, 12-, 18-,~     24-, 36-, 48- and 60-month time-points following AAV2/5-OPTIRPE65 administration.~   "
8431|NCT02946866|"~     The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage~     in adult patients with cerebral cavernous malformation with the goal of informing the~     treatment plan.~   "
8432|NCT02946853|"~     Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for~     patients with heart failure with reduced ejection fraction and specific indication. However,~     many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately~     30-36% of CRT patients are in atrial fibrillation (AF).~   "
8433|NCT02946840|"~     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe,~     and effective technique for obtaining samples from pancreatic masses. A new core biopsy~     needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility~     to achieve a core for histology evaluation and the interchangibility of needle size using~     the same needle shelter and different needle sizes.~   "
8434|NCT02946827|"~     FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are~     characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are~     utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting~     FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability~     to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The~     principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel~     syndrome appear to benefit by restricting intake, possibly because they are hypersensitive~     to intestinal distension.~      The focus of the study is to evaluate if in celiac patients with persistent abdominal~     symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms.~     Moreover the study would like to observe if a dietary restriction in FODMAPs carries the~     risk of nutritional inadequacy.~   "
8435|NCT02946814|"~     This study aims to evaluate the in situ antibacterial activity of a mouthwash containing~     essential oils with and without alcohol on undisturbed de novo plaque-like biofilm~     (PL-biofilm) up to 7 h after its application.~      An appliance was designed to hold six glass disks on the buccal sides of the lower teeth,~     allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then~     performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5,~     and 7 h later. After a washout period, the same procedure will be repeated with a sterile~     water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital~     staining, samples will be analyzed using a confocal laser scanning microscope analysing~     their bacterial viability and thickness.~   "
8436|NCT02946801|"~     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised~     to be the primary aetiological factor in the development of chronic gingivitis. Based on~     this association, the current treatment of gingivitis is focused on biofilm disruption,~     which will normally include mechanical processes, both professionally and at home. However,~     for patients, it is not easy to achieve a proper level of plaque control. The efficient~     plaque control techniques are very time consuming and require a special motivation and~     skills for their optimum use. It was at this point where mouthwashes become important, due~     to the fact that they include diverse types of antimicrobial agents to complement the~     results of mechanical oral hygiene measures.~      The essential oils have been presented as a realiable alternative to the gold Standard~     (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain.~     Some years ago, a new alternative without alcohol has been launched to the market. This~     formulation has not been already deeply tested specific antiplaque studies in which the~     structure of the biofilm remained intact.~      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial~     agents (based on an essential oils formulation with and without alcohol) in the short term~     with a posterior analysis on non-destructured biofilm with Confocal Laser Scanning~     Microscope combined with fluorescence staining.~   "
8437|NCT02946788|"~     This is a single center open label study intended to provide photo documentation and time to~     response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to~     severe non-nodular inflammatory acne vulgarism.~   "
8438|NCT02946775|"~     To define the etiologic agents of community acquired bacteremic syndromes (defined as~     septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting.~   "
9369|NCT02934594|"~     Patients with metastatic spinal cord compression (MSCC) are treated with different options~     according to the life expectancy. Survival and surgical outcome can be influenced by~     surgical timing in MSCC patients treated with palliative decompression.~   "
8439|NCT02946762|"~     At correctional facilities in Zambia and South Africa, a cross-sectional study design will~     be used to characterize the full continuum of integrated HIV/TB care under Treatment as~     Prevention (TasP), and will enrich this approach by: 1) using individual-level cohort data~     for HIV-infected inmates to assess ART uptake under TasP/Universal Test and Treat (UTT), as~     well as 6-month virological suppression and retention in care for inmates initiating ART;~     and 2) mixed methods to identify health-system, corrections-related socio-cultural and~     individual-inmate barriers to and facilitators of TasP/UTT to refine TasP implementation;~     and 3) conducting a retrospective chart review using routine data from Ministry of Health~     registers to reconstruct an approximate HIV and TB cascade for all inmates (HIV-infected and~     HIV-uninfected) at 3 and 12 months into TasP/UTT implementation.~   "
8440|NCT02946749|"~     As the two-child policy implementation, caesarean women's clinical pregnancy is a huge~     problem again, Especially the placenta planting abnormal disease is a serious threat to the~     maternal health and life. Through this research, the investigators can obtain relevant~     epidemiological data and provide objective data for the department of public health policy;~     Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill~     the blank in this field, and high-risk groups in the early stages of pregnancy will be taken~     proper disposal, the related complications will be reduced to ensure the safety of maternal.~   "
8441|NCT02946736|"~     This study is a randomized controlled trial that will assess the effects of (1) the~     Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2)~     sleep/cognitive effectiveness feedback intervention on health and well-being among full-time~     employees in the Oregon National Guard, their supervisors, and their families. The~     interventions involving both health protection and health promotion are expected to~     contribute to improvements in employees' and their supervisors' sleep, risk behaviors,~     mental and physical health, and injury, as well as employees' and their spouse/partners'~     family experiences, health and well-being, and workplace outcomes.~   "
8442|NCT02946723|"~     Overactive bladder(OAB,Urgency) was determined by International Continence Society as~     Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency~     urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious~     pathology.The SNM treatment involves a two-stage surgical procedure performed under local~     anesthesia. The device include IPG (implantable programme generator) and lead. In the~     initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2~     weeks assessment. This allows your doctors and you to assess your initial response according~     to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the~     IPG.~      X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real~     time visual guidance ,easy to operate by doctors and a radiation free option to challenge~     anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and~     dedicating to developing better guidance technique in surgery.~      The study here compare the efficacy and safety of ultrasound versus X ray guidance technique~     in SNM.~   "
8443|NCT02946710|"~     This research will be achieved by the assessment of p75NTR-ECD expression (total and linked~     to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of~     patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal~     dementia and non-neurodegenerative dementia.~   "
8444|NCT02946697|"~     This study is a randomized controlled trial (RCT) to assess the impact of a culturally based~     social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer~     survivors.~   "
8445|NCT02946684|"~     This project seeks to determine whether estradiol suppression achieved with adjuvant~     treatment with an aromatase inhibitor improves end-follicular and luteal phase parameters~     during IVF. 128 patients will be randomized to either placebo or active treatment.~   "
8446|NCT02946671|"~     To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and~     ONO-4538 (anti-PD-1).~      To assess the behavior of immune cells in peripheral blood and tumor.~   "
8447|NCT02946658|"~     Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is~     characterized by long-term, often progressive state of poor airflow. Primary symptoms~     include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary~     inflammation and interference with oxygen-carbon dioxide exchange.~      Air pollution and tobacco smoking are felt to be the most common cause of these issues.~     Diagnostic testing is based on poor airflow measured by lung function studies and whose~     symptoms do not improve much with antiasthma bronchodilators.~      Study is an interventional study to document the safety and efficacy of use of AD-cSVF in~     chronic broncho-pulmonary disease groups.~   "
8448|NCT02946645|"~     Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern~     dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD~     patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of~     TMD. To our knowledge, no specific trials have been designed for the evaluation of the~     efficiency of physiotherapy vs neuromuscular bites in TMD patients.~      The aim of this trial is to evaluate the efficiency in term of cranial muscles~     electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs~     manual physiotherapy therapy compared to placebo.~   "
8449|NCT02946632|"~     In this study, the investigators will assess the efficacy and tolerability of a novel,~     initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared~     to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2~     diabetes.~   "
8450|NCT02946619|"~     This study is a randomized controlled trial (RCT) with the aim of determining the cultural~     sensitivity, feasibility, and effectiveness of an expressive writing intervention for~     Chinese breast cancer survivors.~   "
8451|NCT02946606|"~     This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study~     designed to assess the safety, tolerability, efficacy, pharmacokinetics, and~     pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.~   "
8467|NCT02946398|"~     Procedures for identification of high-risk elderly patients in the emergency department are~     lacking.~      We aim to identify the risk factors associated with an adverse outcome in elderly patients~     who visit the emergency department (ED). Second, we aim to find practical tools to identify~     those elderly patients who are at risk for an adverse outcome in an early stage (by applying~     and testing triage and risk stratification scores, clinical impression and laboratory~     results).~   "
8452|NCT02946593|"~     The purpose of the study is to examine the feasibility of the program and data collection~     protocol to plan a multisite clinical trial. The program, Stroll Safe, an outdoor fall~     prevention program, will take place in the lab space of the New York University occupational~     therapy department and in the surrounding neighborhood.~      Twenty-four people who meet the inclusion criteria will be enrolled after informed consent.~     Recruitment will include follow up with people who expressed interest in the fall prevention~     program during a survey study conducted by the PI, and interested members of community-based~     programs for seniors who have agreed to be community partners for this study. Twelve~     participants will be assigned to the 7-week program and 12 will receive written information~     on outdoor fall prevention (control group).~      The topics addressed in the once a week, 7-week outdoor falls prevention program, for which~     a treatment manual has been developed, are based on the results of a survey conducted of~     community dwelling older adults that identified gaps in knowledge and use of prevention~     strategies, and the related literature. The program includes pre-set modules, however,~     participants will be able to voice individual concerns and problem-solve solutions during~     group discussions. Using an ecological perspective, the Health Belief Model, and problem~     solving theory as a guide, the intervention will include a didactic component, group problem~     solving, practical application of strategies, and self-advocacy regarding reporting problems~     to the city.~      Analysis will primarily focus on process measures.Post-intervention, semi-structures~     interviews will be conducted and analyzed to assess strengths/limitations of the program and~     participant's attribution of any behavioral changes to the intervention. Although~     statistical significant is not anticipated in this small feasibility study, repeated~     measures ANOVA will be used to examine changes in Falls Efficacy Scale-International~     (FES-I), Outdoor Falls Questionnaire (OFQ) and Falls Behavioral Scale for the Older Person~     (FaB) scores from pre to post-test for the treatment and control groups. Effect sizes~     (Cohen's d) will also be calculated. Change in number of stumbles, trips, slips, and falls~     before and after the program will also be analyzed.~      Data will be collected on falls self-efficacy and strategy use at study enrollment~     (Baseline), after completion of the 7 week program (1st Post-test), and at 2 months~     post-program completion (2nd Post-test). Participants will be asked to keep daily diaries of~     stumbles, trips, slips, and falls from the time they enroll in the study until two months~     following the completion of the program.~   "
8453|NCT02946580|"~     Constipation is a known complication of the postoperative period after spinal surgery, where~     prescription pain medicines called opioids are traditionally used in high doses for the~     treatment of surgery-related pain. The goal of this study is to determine the effectiveness~     of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by~     opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.~   "
8454|NCT02946567|"~     The investigators are studying the educational potential of games, with the goal of~     developing a game to improve learning and promote healthy hearing behaviors.~      The project is looking for adolescents and young adults that play games to share their~     experience and learning from playing games.~      The investigators ask participants to fill out an enrollment form/informed consent, complete~     surveys on healthy hearing habits, and play a game provided by the project.~      This projects aims the development and evaluation of a game to educate teenagers and young~     adults about noise-induced hearing loss, enhance knowledge about hearing, and promote~     healthy hearing behaviors with the potential to improve hearing health care.~   "
8455|NCT02946554|"~     The study will assess the safety of two dose regimens of HepaStem in Patients with ACLF up~     to Day 28 of the active study period.~   "
8456|NCT02946541|"~     This is a randomized, double-blind, placebo-controlled, phase III clinical trial to~     investigate the efficacy and safety of evogliptin after oral administration in patients with~     type 2 diabetes who have inadequate glycemic control on diet and exercise.~   "
8457|NCT02946528|"~     Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable~     interest amongst nephrologists. Several publications have provided assurances that~     urgent-start PD is indeed feasible and can serve patients well; however, most of the studies~     have small sample sizes, retrospective design, and the impact of the urgent-start dialysis~     modality on outcome, especially on short-term complications, has not been directly~     evaluated. Therefore, we started this multi-centered, prospective, interventional study~     compared the dialysis-related complications and survival rate directly between urgent-start~     PD and HD groups with a large sample to determine the feasibility and safety of urgent-start~     PD as an alternate initial modality of dialysis for patients who require urgent initiation~     of dialysis therapy.~   "
8458|NCT02946515|"~     This study is looking at the feasibility and efficacy of using SIMmersion's PeopleSim~     technology to train providers through role playing simulations to effectively conduct~     discussions with parents to provide intervention for, and reduce the likelihood of~     progression to childhood obesity.~   "
8459|NCT02946502|"~     The purpose of this study is to test the association between ICU acquired weakness as~     evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning~     outcome~   "
8460|NCT02946489|"~     Cannabis use disorders remain a significant public health problem. The pharmacological~     facilitation of behavioral treatment represents a promising strategy for addressing~     disordered cannabis use. Cannabis use disorders are recognized to be associated with various~     vulnerabilities that complicate the course of treatment and that may be amenable to~     glutamate modulators. The purpose of this randomized, double-blind, controlled trial is to~     test various glutamate modulators in conjunction with motivational enhancement therapy (MET)~     and mindfulness based relapse prevention (MBRP) for cannabis use disorders.~   "
8461|NCT02946476|"~     To better understand the public health prognostic impact of noncardiac chronic illnesses, we~     explored the attributable risk of noncardiac comorbidities on outcomes between heart failure~     patients with reduced ejection fraction (HFREF) and heart failure patients with preserved~     ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted~     hazard ratio (HR) and the population attributable risk were used to compare the~     contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that~     contributed to high attributable risk were: anemia, chronic kidney disease, chronic~     obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These~     findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar~     results.~   "
8462|NCT02946463|"~     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients~     with PNH who have not previously used a complement inhibitor.~   "
8463|NCT02946450|"~     The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in~     CT scanning patients~   "
8464|NCT02946437|"~     Feasibility and safety of short term application of sevoflurane in patients with SAH treated~     with aneurysm coiling or clipping in the setting of a neurointensive care unit.~   "
8465|NCT02946424|"~     This is a double blind, randomized, placebo -controlled clinical trial with the primary goal~     of determining the osteogenic benefits of simvastatin in acute SCI.~   "
8466|NCT02946411|"~     The study is designed to test if there is any correlation between the glucose levels in the~     postoperatory period and the length of hospital stay.~   "
8468|NCT02946385|"~     The purpose of this study is to compare the effectiveness of 2 (given at 0, 2 months) or 3~     (given at 0, 2, 6 months) doses of the GSK MenABCWY vaccine administered to healthy~     adolescents in study V102_15 (NCT02212457), against a panel of randomly selected U.S. N.~     meningitidis serogroup B invasive disease strains at 24 months after the last meningococcal~     vaccination in V102_15 (NCT02212457) and response to a booster dose.~   "
8469|NCT02946372|"~     Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects~     people aged over 60, and twice common in women than men.~      The vast majority of cases are idiopathic. Without treatment, the macular hole evolves~     through a series of stages until the extension of the diameter (up to 500 microns and higher~     values). With a fully developed macular hole, patients complain of metamorphopsia and~     decreased visual acuity.~      This pathology has clearly benefited from advances in microsurgery and better understanding~     of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana~     vitrectomy with or without internal limiting membrane (ILM) peeling and placement of~     intraocular gas tamponade.~      The postoperative closure rate is close to 80%, but strongly depends on the initial~     characteristics of the hole, its diameter remaining the main prognostic factor. Thus for~     macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular~     holes above 400 microns. In case of surgical failure, one or more reoperations can be~     proposed, but with a lower closure rate.~      The quest for a surgical technique presenting a greater success rate is a common goal to all~     retinologists.~      Here the investigators propose a new surgical technique, derived from the FLAP method, and~     consisting of an inner limiting membrane transposition.~      The objective of this study is to evaluate the feasibility of a new surgical technique for~     the treatment of macular holes already operated but without macular hole closure, allowing~     these patients a new therapeutic alternative. The success of this technique will be~     confirmed by detecting postoperatively the presence of the transposed internal limiting~     membrane into the foveal region.~   "
8470|NCT02946359|"~     This is a phase II, prospective, single arm, non comparative study with crizotinib combined~     with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK~     translocation or ROS1 translocation or MET amplification~   "
8471|NCT02946346|"~     Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear~     within a few months or years. There infections are much less studies than chronic~     infections, even though they represent the main reservoir for the virus. The goal of this~     project is to decipher the kinetics of the virus and of the host immune response in acute~     HPV genital infections in your women. This will be performed by following women~     longitudinally and regularly in order to measure variations in virus load, immune cell~     count, cytokine concentration and antibody titers. The investigators will also investigate~     the interaction between these kinetics and host genetics and host vaginal microbiota~   "
8472|NCT02946333|"~     Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for~     Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this~     protocol can participate. The participating patients must sign an informed consent, which~     the investigator who will collect the study variables in an electronic case report form~     (eCRF) will provide to them. The investigators must recruit at least 450 patients in a~     24-month period.~   "
8473|NCT02946320|"~     The purpose of this study is to determine the optimal way of predilatation for BVS~     implantation.~   "
8474|NCT02946307|"~     The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel~     eluting balloon in the treatment of Chinese patients with coronary heart disease and small~     vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.~   "
8475|NCT02946294|"~     The purpose of this study is to compare the analgesic profile of modified pectoral nerves~     block and serratus plane block in patients undergoing mastectomy.~   "
8476|NCT02946281|"~     The primary objective of Do CHANGE is to develop a health ecosystem for integrated disease~     management of citizens with high blood pressure and patients with ischemic heart disease or~     heart failure. The system will give them access to a set of personalized health services in~     a near real-time fashion. This disruptive system will incorporate the behaviour change~     methods, such as Do Something Different, in conjunction with new innovative~     wearable/portable tools that can monitor behaviour and clinical parameters in normal living~     situations.~   "
8477|NCT02946268|"~     The purpose of this study is to determine the ideal delivery of local anesthetics for pain~     control when using continuous interscalene peripheral nerve catheters for shoulder surgery.~      The study will be conducted in three stages. In the first stage the ideal bolus volume of~     ropivacaine will be determined. In the second stage the optimal rate of delivery of the~     bolus (infusion rate) will be determined. Finally, once both the ideal volume and infusion~     rate has been determined, the optimal interval between boluses of local anesthetic will be~     determined.~   "
8478|NCT02946255|"~     The investigators propose to examine the effectiveness of a brief intervention that might~     better facilitate the transition into the community for people with schizophrenia. The~     intervention is called the Welcome Basket. It involves Peer Support Workers connecting with~     and supporting hospitalized individuals in the days before discharge and again in the~     community in the first month immediately following discharge. The investigators will compare~     the outcomes of discharge from hospital as usual with the full version of the welcome basket~     and a preliminary test of an abbreviated 2 visit version of the intervention.~   "
8479|NCT02945189|"~     This is a sample collection study, participants will be required to collect one (if last~     menstrual period ≥12 months) or two (if last menstrual period <12 months) urine samples and~     return them to the study site, together with collection sample information. Participants~     having a menstrual cycle within the last 6 months will also be required to provide follow-up~     information on pregnancy status and date of next menstrual bleed.~   "
8480|NCT02945176|"~     The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination~     with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is~     intended to be used together with the hand-held Mesograph reading device to telemetrically~     measure the intraocular pressure (IOP) of patients with a BKPro.~      The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system~     in patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the~     12 month period beginning at implantation.~   "
8483|NCT02945137|"~     The accurate diagnosis of H. pylori infection is an important step for establishing the~     strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the~     first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT~     shows rapid result with good sensitivity and specificity. Several study reported that H.~     pylori density was related to positive reaction time of RUT. However, there was no study~     comparing the positive reaction times of RUT according to biopsy site, degree of gastric~     atrophy, and intestinal metaplasia.~   "
8484|NCT02946229|"~     The purpose of this study is to enable longitudinal data collection of a library of~     ultrasound images and associated case data in a diseased population with varied sonographic~     findings. This data is required to support future engineering development of new ultrasound~     technologies.~   "
8485|NCT02946216|"~     The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA~     samples in EGFR-wildtype NSCLC~   "
8486|NCT02946203|"~     In this research study, two different oral contrast materials that can be used for CT or MR~     enterography will be studied. This study is designed to compare which oral contrast material~     (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality~     exams.~   "
8487|NCT02946190|"~     This is a phase II, randomized double-center, and observer-blind controlled pilot vaccine~     trial in 11 to 15 years old healthy subjects to assess the immunogenicity of the genetically~     detoxified pertussis toxin (rPT) included in a novel acellular pertussis vaccine (Pertagen®)~     manufactured by BioNet-Asia when delivered by the intramuscular route to adolescents~     previously primed and boosted with chemically-detoxified PT, along with Td-pur® and in~     comparison with that of Boostrix® dTpa.~      At Day 0, eligible volunteers will undergo a venous bleed for the determination of baseline~     values and enter the randomization scheme, being allocated to one of two groups: A~     (Pertagen® + Td-pur®), B (Boostrix® dTpa).~      Randomized participants will receive one dose of Pertagen® and Td-pur® (Group A) or 1 dose~     of Boostrix® dTpa (Group B) by intramuscular injection in the deltoid. All subjects will be~     observed in the Plateforme de Recherché Pédiatrique for 30 minutes after immunization.~      Post-immunization local and systemic reactions will be followed up for 7 days after~     immunization. Adverse events will be followed for 28 days after immunization.~      At Day 28, a second visit (study end visit) will take place for safety evaluation and blood~     draw for immunogenicity evaluation.~      Blood draws performed on Day 0 (Baseline) and Day 28 will be used to evaluate immune~     response to study vaccines.~      The primary statistical analysis will be performed with visit 2 (Day 28) data to compare the~     immunogenicity and safety of one dose of Pertagen®, given simultaneously with Td-pur®, to~     those elicited by Boostrix® dTpa.~   "
8488|NCT02946177|"~     In this study the investigators propose a randomized controlled trial to evaluate the effect~     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro~     fertilization as donor egg recipients.~   "
8489|NCT02946164|"~     This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the~     concept of gamification. The objective of the program is to encourage young men who have sex~     with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs)~     and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI~     incidence. Gamification is the application of game elements, like points, badges, and~     rewards, to non-game settings.~   "
8490|NCT02946151|"~     The study is a two-phase study, which aims to investigate the performance of a novel~     electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous~     implantation with long-term monitoring in mind.~   "
8491|NCT02946138|"~     The aim of this research project is to assess the efficacy and toxicity of hypofractionated~     carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for~     the treatment of hepatocellular carcinoma~   "
8492|NCT02946125|"~     This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601~     for dilation of the pupil. A single micro dose of EYN-1601 will be compared to single doses~     of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.~   "
8493|NCT02946112|"~     The aim of this study is to assess the relationship between shoulder position and the~     presence of pain in volleyball players. To do this, will be measured pain sensation and the~     position of acromion process~   "
8494|NCT02946099|"~     Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc~     reciprocating files versus that resulting after using ProTaper Next rotary files in~     asymptomatic necrotic molars.~   "
8495|NCT02946086|"~     This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and~     participation of children with unilateral CP, as well as neuroplastic changes induces by the~     treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation~     will be measured.~   "
8496|NCT02946073|"~     This study will be a Phase III, placebo-controlled, multicenter study with an~     enriched-enrollment withdrawal design to evaluate the efficacy and safety of CAM2038 in~     opioid-experienced subjects with moderate to severe CLBP that requires continuous,~     around-the-clock (ATC) opioid treatment. The study will comprise 5 phases: a Screening Phase~     (up to 2 weeks), a Transition Phase (up to 2 weeks), an open label Titration Phase (up to 10~     weeks), a Double-Blind Phase including a Final Study Visit (12 weeks), and a Follow-up Phase~     (4 weeks). The overall duration of participation will be up to 32 weeks, from Screening~     Phase to Follow up Phase, including 12 weeks of double-blinded treatment.~   "
8497|NCT02946060|"~     This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without~     Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants~     will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or~     Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects~     of these interventions on mood, perceived exertion and dissociative attention among patients~     participating in cardiac rehabilitation.~   "
8498|NCT02946047|"~     The goal of this study is to determine the safety and tolerability of Ixazomib in HIV~     infected patients who are on a stable regimen of ART that suppresses HIV replication. A~     secondary goal is to determine the effect of ixazomib on the size of the HIV reservoir.~   "
8499|NCT02946034|"~     Single arm, open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin~     for adults with chronic kidney disease and hepatitis C.~   "
8503|NCT02945982|"~     Portal hypertension is a common pathology in chronic liver disease, particularly in liver~     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China.~     The basic reason for portal hypertension in HBV is the largely deposition of hepatic~     extracellular matrixes which causes high pressure in liver vessels. One of the most common~     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective~     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic~     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the~     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals~     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu~     has been found to enhance the degradation of collagens in fibrotic liver and have a good~     action against liver fibrosis in patients with chronic hepatitis B. However, there are no~     high quality clinical evidences which can demonstrate if the combination of anti-viral and~     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate~     and bleeding rate of gastroesophageal varices.~   "
8504|NCT02945969|"~     The proposed randomized controlled trial will test the effect of dietary sodium reduction on~     albuminuria in patients with proteinuric chronic kidney disease. Results from this study~     will clarify the role of dietary sodium reduction in management of patients with proteinuric~     chronic kidney disease and its potential to halt the progression of chronic kidney disease.~   "
8505|NCT02945956|"~     Portal hypertension is a common pathology in chronic liver disease, particularly in liver~     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China.~     The basic reason for portal hypertension in HBV is the largely deposition of hepatic~     extracellular matrixes which causes high pressure in liver vessels. One of the most common~     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective~     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic~     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the~     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals~     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu~     has been found to enhance the degradation of collagens in fibrotic liver and have a good~     action against liver fibrosis in patients with chronic hepatitis B. However, there are no~     high quality clinical evidences which can demonstrate if the combination of anti-viral and~     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate~     and bleeding rate of gastroesophageal varices.~   "
8506|NCT02945943|"~     Our purpose was to examine the combined effects of thrust mobilization of the proximal and~     distal ankle joints in conjunction with a six-week rehabilitation program on ankle function~     in subjects reporting chronic ankle instability (CAI).~   "
8507|NCT02945930|"~     To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of~     Esophagogastric Varices.~   "
8508|NCT02945917|"~     The use of esophageal balloon catheter to estimate pleural pressure has gained renewed~     popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more~     pathophysiological-based approach to ventilator strategy in acute respiratory distress~     syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter~     derived parameters can be influenced by several patient-related or technical-related~     factors.~      During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and~     derived measurements obtained using different esophageal balloon calibration volumes.~   "
8509|NCT02945904|"~     Purpose of this clinical trial is to improve prediction of outcomes from surgical~     intervention in patients with Primary aldosteronism, and evaluate the merits of non-invasive~     metomidate PET CT versus adrenal vein sampling in the diagnosis of surgically correctable~     aldosteronism.~   "
8510|NCT02945891|"~     Study aims to support development of evidence based health care in Norway through evaluating~     recently proposed technological improvements in cervical cancer control before their routine~     use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human~     papillomavirus (hrHPV) testing compared with a physician-taken sample.~   "
8511|NCT02945878|"~     This is a prospective, observational study to analyze the clinical and dosimetric factors~     about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal~     carcinoma patients and try to find the indicators for acute radiation oral mucositis.~   "
8512|NCT02945865|"~     It is estimated that 45-80 % of nursing home residents have substantial pain at any given~     time. Residents with impaired cognition have been found to report chronic pain more often,~     more frequent and more severe, compared to residents with normal cognition. Approximately~     3/4 of permanent residents in nursing homes in Norway have developed dementia. The burden of~     dementia is often compounded by painful conditions. Despite over a decade of research on the~     subject, inadequate pain assessment and management remain significant problems among~     institutionalized older adults, with and without dementia. The poor pain management in~     patients with dementia has been attributed, at least in part, to difficulties with, and lack~     of, pain assessment in this population. Therefore, this study seek to determine the effect~     of regular pain assessment.~   "
8513|NCT02945852|"~     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and~     etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive~     small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is~     no standard treatment recommendation for this group of patients who failed to second-line~     therapy and had good performance status. Apatinib has been approved as a second-line~     treatment for advanced gastric cancer. Several phase III clinical studies of non small cell~     lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less~     toxic side effects and better patient tolerance. However, the clinical application of~     apatinib in small cell lung cancer is still lack of evidence-based medicine. And this~     clinical trial is designed to prospectively investigate the efficacy and safety of apatinib~     in refractory or recurrent ED-SCLC patients in our center.~   "
8587|NCT02944812|"~     This trial intends: 1.To evaluate the concentration of Chidamide in the serum and~     cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to~     evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous~     system) distribution.~      2. To evaluate the efficiency and safety of Chidamide in PTCL patients.~   "
8514|NCT02945839|"~     Collectively, evidence shows that a combination of medication and behavioral therapy is most~     effective for migraine care. The ED is a critical point of contact with the health care~     system for many migraine patients; in current practice, it is a missed opportunity to~     initiate and establish a comprehensive migraine management paradigm. Behavioral headache~     treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral~     therapy (CBT)) are effective migraine treatment options that are essentially free of side~     effects. PMR has also been successful as a technique that patients can do independently.~     Studies have shown that combination pharmacological-behavioral therapy is most effective for~     migraine treatment.~      Several aspects of this study are innovative, including: 1. Initiation of preventive~     medication in a timely manner for migraineurs who present to the ED. 2. Introduction of~     PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a~     smartphone application-based product (a minimal contact based behavioral therapy) in the ED~     setting to reduce headache disability, frequency, and intensity.~   "
8515|NCT02945826|"~     The purpose of this study is to investigate the applicability of urokinase plasminogen~     activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of~     glioblastoma.~   "
8516|NCT02945813|"~     The main objective of the trial is to determine if Salvation Radiotherapy (SRT) at a dose of~     70 Gy plus metformin is superior to SRT at a dose of 70 Gy plus placebo in the endpoint of~     time to progression after prostatectomy failure.~   "
8517|NCT02945800|"~     The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the~     formation or growth of tumors in participants with relapsed or refractory osteosarcoma,~     Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of~     time during and after treatment that their disease does not get worse. Researchers also want~     to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.~   "
8518|NCT02945787|"~     Results of a recently completed National Cancer Institute (NCI) funded trial of an~     intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24-~     month follow-up period, further supporting the utility of extended self-help for promoting~     and maintaining tobacco abstinence. Investigators have recognized that wide-scale~     implementation, and therefore public health impact, would be enhanced by the availability of~     a Spanish-language version to reach the largest and fastest growing ethnic minority~     population of smokers.~      The goal of this study is to address this gap by testing a Spanish-language version of the~     validated self-help smoking cessation intervention. If demonstrated effective, the proposed~     intervention would represent an easily disseminable and low-cost intervention with~     significant public health impact for Hispanic/Latino smokers throughout the United States.~     The aims of this project are to test the efficacy of a Spanish-language version of a~     validated, extended self-help intervention for smoking cessation among Spanish-speaking~     smokers against usual care control. Participants (N = 1240) recruited nationally will be~     randomized to the two arms.~   "
8519|NCT02945774|"~     Neuroinflammation is increasingly implicated as a potential critical pathogenic mechanism in~     a variety of neurologic and psychiatric disorders. This study will use hybrid PET/MRI~     imaging to evaluate neuroinflammation and its relationship to cerebral perfusion in~     frontotemporal dementia (FTD). Patients with FTD will be recruited from the Cognitive~     Neurology and Aging Brain clinics at Parkwood Institute and will undergo neurocognitive~     assessment and MRI/PET using the PET ligand FEPPA which binds to activated microglia, a~     marker of neuroinflammation. Correlations will be conducted to determine whether abnormal~     neuroinflammation is present in Frontotemporal dementia and whether differential patterns of~     neuroinflammation are present in different FTD clinical and molecular subtypes, and to~     determine the relationship between neuroinflammation, cerebral perfusion using arterial spin~     labeling MRI imaging techniques, and indices of brain structure including volumetric and~     white matter analysis.~   "
8520|NCT02945761|"~     Surgeons easily get wound infections. Most wound infections will be cured by applying~     medicines and changing dressing in very short period of time. But some wounds are severely~     contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna,~     so changing dressing takes a very long time. In order to better change the dressing, it~     needs to expose the wound thoroughly, which requires to completely open the healed skin, so~     the healing will be slowed down. Some scholars lay stress on prevention. Wound infection~     control concerns prevention--not therapy--of an infrequent but expensive kind of surgical~     morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of~     topical anti-infectives, which invade the bacteria where they reside, and, consequently,~     reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a~     viable treatment option for infections encountered in burns, open wounds, and chronic~     ulcers. But it is expensive and is difficult to acquire silver-containing dressings. And~     Recent findings, however, indicate that the compound delays the wound-healing process and~     that silver may have serious cytotoxic activity on various host cells. (4) As High~     concentration of sugar solution, honey appears to heal partial thickness burns more quickly~     than conventional treatment (which included polyurethane film, paraffin gauze,~     soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected~     post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use~     of another high-concentration of sugar solution (HCSS) to lavage infected wounds when~     changing dressings.~   "
8521|NCT02945748|"~     Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement~     in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic~     measurements will be carried out before and after therapy have been made, including~     customary hemodynamic parameters, echocardiography and USCOM studies.~      All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction.~     Trend in USCOM parameters will be compared to echocardiography CO parameters.~   "
8522|NCT02945735|"~     The purpose of this study is to determine whether giving gaze-contingent feedback is an~     effective attention modification procedure, helping in the treatment of Major Depressive~     Disorder (MDD)~   "
8608|NCT02944539|"~     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,~     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with~     the initiation and development of gastric cancer.The aim of this study was to explore~     association between mtDNA content in peripheral blood cells could be used as a risk~     predictor for gastric cancer.~   "
8523|NCT02945722|"~     S. aureus nasal carriage is a well-known risk factor for S. aureus infections in~     hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases~     We recently shown that persistent carriers of S. aureus, not intermittent ones are at~     increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped~     based on one nasal sample the determination of carriage status (persistent, intermittent or~     non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce~     significantly S. aureus infections however, multiples schedules of decolonization have been~     proposed to all S. aureus carriers. To date, there is no national guideline for~     decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose~     screening and decolonization of S. aureus carriers. The aim of the study is therefore to~     evaluate the impact of a targeted decolonization of S. aureus persistent carriers using~     mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S.~     aureus infections in HD patients compared to the absence of decolonization using a~     randomized open study methodology.~   "
8524|NCT02945709|"~     The purpose of this study is to explore the efficacy of Attention Control Training for Post~     Traumatic Stress Disorder (PTSD).~      ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in~     combat veterans (Badura-Brack, et al., 2015). It is now important to continue the~     examination of ACT's efficacy in additional populations of patients with PTSD. Such~     extension of treatment to other traumatic experiences raises the question of whether the~     threatening content of the training material could be personalized for each patient.~   "
8525|NCT02945696|"~     The investigators will perform a prospective randomized study to compare the effectiveness~     of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and~     with ultrasounded guided abdominal wall blocks.~   "
8526|NCT02945683|"~     The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial,~     whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3~     (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic~     dermatitis~   "
8527|NCT02945670|"~     The purpose of this study is to learn what women of childbearing age think of Long Acting~     Reversible Contraception. A variety of myths regarding LARCs have been described in the~     literature. This study is designed to asses women's cultural belief's regarding LARCs.~     Investigators are looking to collect information from women in general, rather than solely~     who are seeking contraception. Investigators will be recruiting women ages 18-45 years from~     seven family health centers affiliated with UPMC. Participants will be asked to a attend a~     60-90 minutes focus group session. During the session the facilitator will try to engage~     participants in a discussion about contraception in general. They will also be asked to~     complete a short demographic survey of 8-12 questions. Data from focus groups will be~     assessed for recurring themes which will be used to create a cultural survey instrument that~     will be used in the second phase of the study.~   "
8528|NCT02945657|"~     The purpose of this study is to assess the pharmacokinetic parameters and safety of topical~     MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use~     conditions.~   "
8529|NCT02945644|"~     Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal~     dosing is unknown. This study looks at what dose of trazodone has the best balance of~     potential benefits to side-effects in people with obstructive sleep apnea who are either~     starting on positive airway pressure therapy or not adherent to it. Participants will be~     randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for~     14 days. The investigators will monitor side-effects and adherence to positive airway~     pressure therapy.~   "
8530|NCT02945631|"~     The purpose of this study is to establish the efficacy and toxicity of low dose~     chemoradiotherapy after induction chemotherapy in patients with locally advanced HPV+~     oropharynx cancer and establish prognostic factors that would apply to help select patients~     for this treatment in the future.~   "
8531|NCT02945618|"~     The objective of this exploratory randomized control trial is to compare, in participants~     with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations~     between two groups of subjects who undergo a conventional rehabilitation program with~     (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS~     will lead to a faster reduction of symptoms and functional limitations, and a faster return~     to daily living activities.Thirty-six participants of 18 years of age and older with acute~     LAS (sustained a LAS three days or less before the first evaluation session) will be~     recruited and randomly assigned to either a group receiving conventional rehabilitation~     program with the addition of CRYOFOS (experimental group; n=18), or to a group only~     receiving the conventional rehabilitation program (comparison group; n=18). This~     single-blind (evaluator), parallel-group RCT will include five evaluation sessions over 6~     weeks (baseline, day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd~     weeks: 3 sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The~     primary outcome will be the functional limitations, evaluated using the Lower Extremity~     Functional Scale (LEFS).~   "
8532|NCT02945605|"~     This study examines the effect of early vestibular rehabilitation on reducing physical~     post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to~     achieve medical clearance to return to activities such as sports and work activities. Half~     of the participants will receive early vestibular rehabilitation added to standard of care,~     while the other half will receive standard of care only.~   "
8549|NCT02945384|"~     This project involves the development of a scaled-up model of a successful dual-generation~     intervention targeting attention, stress, and self-regulation in families attending Head~     Start, and improvements of outcome assessments of the intervention. The investigators~     hypothesize that families randomly assigned to receive the intervention, compared to~     families not receiving the intervention, will show improved brain function for attention and~     self-regulation and improved physiological function for stress regulation in both children~     and their parents, improvements in child school performance and cognition, and improvements~     in assessments of parent/family well being.~   "
8916|NCT02940509|"~     The goal of this research proposal is to determine if the intraoperative administrative of~     Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain~     in patients on chronic opioid therapy for management of chronic pelvic pain.~   "
8533|NCT02945592|"~     The presented study investigates standardized visual cueing in reading and visual spatial~     task as a treatment method for spatial neglect. In a randomized controlled design patients~     receive either cued reading and visual spatial tasks (intervention) or treatment which is~     unspecific to neglect (control).~      In the intervention condition, patients with left-sided neglect receive intense training,~     including reading and visual spatial task with standardized and adapted visual cueing by the~     therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by~     the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve~     the task.~      For the control condition, all patients receive unspecific treatment without any~     standardized adapted cueing implemented by the therapist.~      To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators~     additionally conduct parietal transcranial direct current stimulation (tDCS) in those~     patients without tDCS exclusion criteria (see exclusion criteria below).~      It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant~     reduction of omissions of word and word parts in reading.~   "
8534|NCT02945579|"~     The goal of this clinical research study is to learn how often breast cancer recurs (returns~     after treatment) in the breast in patients who have been treated with chemotherapy and have~     had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence~     of disease).~   "
8535|NCT02945566|"~     Colorectal cancer is the third most common tumour in the UK, Netherlands and Denmark with~     41000, 14000 and 4000 new cases per year respectively. Standard primary radical Total~     Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage~     rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in~     approximately 5-10% of cases while many more patients have a temporary stoma, some of which~     are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic~     tumours, may not be the optimal method of treatment for early screen-detected tumours and an~     organ preserving strategy may generate significantly less morbidity without substantially~     compromising oncological outcomes.~      TREC was a randomised phase II trial to test the feasibility of randomisation between TME~     and an organ preserving policy of short course pre-operative radiotherapy (SCPRT) delay~     followed by transanal endoscopic microsurgery (TEM). STAR-TREC is a phase II feasibility~     study that will evaluate whether it is possible to accelerate the patient recruitment~     attained in the TREC study, to 4 per month in the first year of recruitment and 6 per month~     in the second. This would demonstrate deliverability of a phase III study.~   "
8536|NCT02945553|"~     Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair~     improves knee biomechanics and function, but neuromuscular dysfunction persist for years~     despite rehabilitation, hindering resumption of normal activities, increasing risk of~     further injury and, in a majority of patients, hastening the development of knee~     osteoarthritis (OA). Our goal in this research study is to evaluate the utility of~     neuromuscular electrical stimulation (NMES), initiated following injury and maintained~     through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile~     dysfunction compared to active control intervention of micro-electrical stimulation.~   "
8537|NCT02945540|"~     This study seeks to evaluate patient satisfaction within the patient therapeutic education~     program gestational diabetes (multidisciplinary and multi-professional program) to see if~     they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are~     questioned on the skills acquired in everyday life, the effective support in personal~     development, development of self-determination capabilities and communication with health~     professionals.~      This study must include all patients participating in the therapeutic education program for~     a year and meeting the inclusion criteria.~   "
8538|NCT02945527|"~     Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no~     additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis~   "
8539|NCT02945514|"~     Provide personally tailored dietary suggestions to participants based on the Personalized~     Prediction Engine (patent pending) owned by DayTwo.~   "
8540|NCT02945501|"~     The purpose of this study is to determine if the enhancement of electroencephalographic~     (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation~     (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative~     properties of that period of sleep and improves performance during a subsequent period of~     sleep deprivation.~   "
8541|NCT02945488|"~     The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and~     nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases~     (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to~     mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in~     preconception women with IBD. The investigators hypothesize that the combination of~     anti-inflammatory exercise and nutritional interventions will have a synergistic effect on~     managing major symptomatic concerns associated with IBD, reducing inflammation, and~     improving fertility status in preconception women with IBD, as compared to either~     intervention independently.~   "
8542|NCT02945475|"~     This study is aimed at understanding neuroendocrine responses to different types of sugars~     and how this influences feeding behavior among lean, obese and obesity prone individuals.~   "
8543|NCT02945462|"~     Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro~     expansion under restricted culturing conditions.~   "
8544|NCT02945449|"~     Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of~     erectile dysfunction in diabetic patients.~   "
8545|NCT02945436|"~     A sample of 600 young (15-25) men who have sex with men (MSM) and transgender persons living~     in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based~     sampling and online ads to examine the efficacy of adding a substance use brief intervention~     (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful~     engagement in HIV care. The investigators will partner with Detroit-area AIDS Service~     Organizations (ASOs) to deliver the intervention.~   "
8546|NCT02945423|"~     Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among~     psychiatric patients. The current project is a systematic examination of catatonia which~     will characterize the phenotype and identify biological correlates that play a central role~     in the pathophysiology and effective pharmacological treatment of this condition.~   "
8550|NCT02945371|"~     Insufficient inhibitory control is one pathway through which early adversity is related to a~     range of problems including excessive alcohol use, tobacco use, and unhealthy eating. The~     proposed research leverages a neurally informed model of inhibitory control and how it can~     be improved to test the efficacy of a person-centered inhibitory control intervention in a~     sample of mid-life individuals with early adversity. The knowledge obtained by this study~     could be scaled into a flexible, low-cost, and wide-ranging intervention to remediate some~     of the effects of early adversity on inhibitory control and thus a number of prevalent~     health risking behaviors.~   "
8551|NCT02945358|"~     A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary~     bypass increases not only cost of patient care but also morbidity and mortality of patients.~     The ability to predict which patient has the tendency to have a prolonged ICU stay would~     help in patient and resource management of the hospital. There are many predictive models~     aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with~     cardiopulmonary bypass but almost all involve the preoperative assessment for proper~     resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning~     intraoperative manipulatable risk factors to improve anesthetic care and patient outcome.~     The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with~     total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of~     this study was to re-validate the performance of OHIR score in the recent context.~   "
8552|NCT02945345|"~     The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area~     and Severity Index (CDASI), established in 2008, is a one-site database study conducted at~     the University of Pennsylvania. The database has yielded valuable information and clinical~     insights into the pathophysiology, disease processes, including psychological responses,~     treatments and quality of life associated with dermatomyositis. The CDASI database~     incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated~     outcome measure of disease responsiveness in patients, and other assessment tools, surveys~     and patient information to help validate the clinical course and quality of life of patients~     with dermatomyositis.~      The CDASI database has led to publication of comparison studies of CDASI and other clinical~     instruments and the effect of dermatomyositis on Quality of Life (QoL).~      The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving~     clinical changes, treatment modalities and patient response to a challenging disease. Data~     will be analysed over a 5 years.~   "
8553|NCT02945332|"~     Specifically, the main objective of this pilot and feasibility study is to develop the~     infrastructure that will be used in a larger study that would be proposed at a later date.~     Hence, this study has two parts. Part A: To establish contacts, collaboration, and~     networking to develop the infrastructure needed to conduct the study, Part B: To recruit~     eight subjects (4 subjects randomly assigned to either a control group or intervention~     group) from a low-income community in East Lubbock who are willing and able to participate~     in this pilot study. The research team's central hypothesis is that the disease burden of~     obesity and related co-morbidities could be attenuated within low-income communities by~     providing incentive-based free access to a safe and convenient exercise facility and earned~     credit to subsidize healthful food cost. The research team's secondary hypothesis is that~     the anticipated decrease in disease burden will make the incentivized changes in lifestyle~     cost-effective.~   "
8554|NCT02945319|"~     The study aims at developing and validating an integrated clinico-molecular model for an~     accurate survival prognostication in newly diagnosed SMZL.~      Already existing and coded tumor biological material and health-related personal data will~     be retrospectively collected. Mutation analysis will be performed by targeted deep next~     generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on~     nuclei isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status~     will be analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status~     of target genes will be assessed by methylation specific PCR on tumor genomic DNA.~      The adjusted association between exposure variables and OS will be estimated by Cox~     regression. This approach will provide the covariates independently associated with OS that~     will be utilized in the development of a hierarchical molecular model to predict OS. The~     hierarchical order of relevance in predicting OS among covariates will be established by~     recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal~     nodes showing homogenous OS. The discrimination capacity of the model will be assessed by~     calculating the c-index. Relative survival analysis will be used to provide a measure of the~     excess mortality experienced by patient's subgroups stratified according to the developed~     hierarchical molecular models, irrespective of whether the excess mortality is directly or~     indirectly attributable to the disease. The model developed in the training set will be~     tested in the validation sets and the model performance (c-index) in the validation set will~     be compared with that in the training set.~   "
8565|NCT02945098|"~     Sixty volunteers with a mean age of 21,8 ± 2,6 years participated in this study, randomly~     distributed into one of the following groups: control, Kinesio taping group with tension in~     the anterior arm region and Kinesio taping group without tension in the same region. All~     subjects underwent an eccentric exercise protocol and three evaluations: before the~     protocol, immediately after and 48h after protocol. The following variables were analyzed:~     sensation of pain as the primary outcome; peak torque normalized by body weight; average~     peak torque; total work and average power, using an isokinetic dynamometer. In addition,~     muscle activation amplitude (Root Mean Square) and median frequency were recorded using~     surface electromyography.~   "
8566|NCT02945085|"~     This study addresses how to achieve better outcomes for cognitively vulnerable~     community-dwelling older adults and their families. Cognitive vulnerability means living~     with dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators~     will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team)~     guided by nurse practitioners with expertise in geriatrics and geriatric psychiatry.~     Specific aims are to determine Home Based Care Team effects on hospitalization or emergency~     department use, and other outcomes including depression, disability, and quality of life.~   "
8567|NCT02945072|"~     The aim of this study is to investigate long-lasting or later behavioral changes in children~     in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)~   "
8555|NCT02945306|"~     Sleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It~     is a combination of snoring most nights during sleep, patchy sleep, short periods of~     stopping breathing (apnoea) and usually big tonsils. Most of these children get better with~     no treatment by 8 years old. It has been suggested that having SDB mean that some children~     concentrate and behave less well during the day and may learn more slowly than children who~     don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out~     tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and~     adenoids (which are normally big at this age) means that most children quickly stop snoring~     and seem to be cured. Unfortunately it is not clear if this operation makes any difference~     to learning compared to just watching the child and letting them grow out of the condition~     (watchful waiting).~      There is no set treatment in the UK today. Children may be offered adenotonsillectomy or~     watchful waiting; it is not know which, long term, is the right thing to do. Therefore the~     investigators wish to do a study looking at these two different treatments to see if there~     is a difference in children's learning over time between the two different treatments. The~     investigators will look at children with SDB, measure their learning (and behaviour) and~     then randomly select which children get one treatment or the other. They will then~     re-measure learning (and behaviour) 7 months later to see if there is any difference between~     the two groups. The investigators will also scientifically measure their sleep. This is~     possibly quite a difficult study to do, the investigators are unsure whether families will~     agree to take part and how easy it will be to measure learning with such young children~     (aged 2:6 - 5).~   "
8556|NCT02945293|"~     The purpose of this study is to examine the relationship between heavy alcohol use, pain,~     and response to pain medication in older adults. We hypothesize that heavy alcohol use may~     impact health physiology.~   "
8557|NCT02945280|"~     Principal investigator are conducting a research study to assess the safety and~     effectiveness of a drug called apixaban for the treatment of upper extremity deep vein~     thrombosis (UEDVT) and clinically important bleeding. Subjects will receive apixaban 10 mg~     by mouth twice a day for 7 days, followed by 5 mg by mouth twice a day for a duration of 11~     weeks. There will be a followup visit at 12 weeks for all participants. A total of 375 are~     to be enrolled.~      The study drug has been approved to treat blood clots. The study drug has not been studied~     uniquely for the treatment of blood clots in the upper extremity however. Because it is~     unknown whether it is effective to treat blood clots in the upper extremity, the principal~     investigator cannot guarantee that there will be benefit to study subjects; however, it is~     hoped that the information obtained from this research study will help treat patients in the~     future.~   "
8558|NCT02945267|"~     Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to~     gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer~     in Asian patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and~     progression free survival (PFS) in patients with unresectable pancreatic cancer. However, it~     is still unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single~     S-1. Maintenance treatment, as a new treatment pattern, has also been tried in these~     patients after first line treatment to improve the OS. Thus, this study is designed to~     compare nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with~     locally advanced or metastatic pancreatic cancer who has benefited from the first-line~     treatment of gemcitabine combined with nimotuzumab and S1 (complete response+partial~     response+stable disease).~      Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group~     nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous~     infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface~     area<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle.~     Treatment interventions will be stopped under the conditions of disease progression or~     intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to~     disease progression since randomization (TTP), secondary points include OS, 3 years overall~     survival rate (OSR) and safety.~   "
8559|NCT02945254|"~     Insufficient and low-quality sleep is a major public health problem that has been linked to~     motor vehicle crashes, industrial disasters, and medical and other occupational errors.~     Persons experiencing sleep insufficiency are also more likely to suffer from chronic~     diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer,~     increased mortality, and reduced quality of life and productivity.~      The number of people using sleep-inducing drugs to increase or improve sleep is steadily~     increasing in the last few decades; however, the side effects of these therapies often~     outweigh the benefits.~      A few small trials and anecdotal findings suggest that continuous background (pink or white)~     noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce~     sleep onset latency.~      In an attempt to find new, alternative solutions to increase sleep quality in people~     suffering from insomnia, the investigators would like to test the effect of surrounding~     filtered white noise on sleep onset latency and subjective sleep quality in healthy~     subjects.~   "
8560|NCT02945241|"~     Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough~     achievement compared to creatinine clearance-guided vancomycin therapy in critically ill~     patients.~   "
8561|NCT02945228|"~     The main objective of this study is to evaluate the safety and effectiveness of~     paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic~     hepatitis C virus (HCV) genotype 2 in daily practice in Japan.~   "
8562|NCT02945215|"~     Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301~     and rituximab in patients with CD20+ B-cell Lymphoma~   "
8563|NCT02945124|"~     To investigate the effects of K Tape on walking pattern, muscle activity and motor~     performance in children with and without developmental coordination disorder (DCD).~   "
8564|NCT02945111|"~     The purpose of this study is to assess whether the degree of anxiety experienced by women~     undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced~     by watching the procedure in real-time on a digital screen.~   "
8568|NCT02945059|"~     The aim of this study is to prospectively evaluate the tolerance and efficiency of a new~     technique of preoperative selective portal vein embolization (PVE) in patients requiring~     major hepatic resection.~   "
8570|NCT02945033|"~     Four retrospective studies were recently published on efficacy of aspirin in patients with~     surgically resected colon cancer. Two of these studies strongly suggested that aspirin used~     in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation~     could act as a targeted therapy with a major protective effect on the risk of recurrence.~     The other two studies did not confirm the benefit of aspirin in this situation. These four~     retrospective studies provide an insufficient level of evidence to demonstrate the benefit~     of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary~     as recommended in the conclusion of these studies and meta-analyses to perform a randomised~     prospective study to validate these data.~   "
8571|NCT02945020|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the~     single-dose pharmacokinetics of dabigatran etexilate in healthy participants.~   "
8572|NCT02945007|"~     The purpose of this study is to assess the relative bioavailability of 1 to 3 concept~     formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess~     the effect of food on the bioavailability of 1 to 3 oral concept formulations of~     JNJ-53718678 when administered as a single oral dose of 500 milligram (mg) in healthy adult~     participants.~   "
8573|NCT02944994|"~     The purpose of this study is to examine effectiveness and implementation for the Unified~     Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed~     veterans.~   "
8574|NCT02944981|"~     The intrathecal administration of morphine is gaining popularity. It is easy to do and can~     reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and~     vomiting more than other methods providing postoperative analgesia. Patients suffering from~     these side effects have to spend a longer period of time recovering in the hospital with~     high cost of medical treatment.~   "
8575|NCT02944968|"~     The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical~     study.~   "
8576|NCT02944955|"~     This is a clinical trial to determine the safety, recommended dose level (RDL), and~     infection control of BLEX 404 Oral Liquid in combination with azacitidine in patients with~     International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2~     (int-2) or high-risk myelodysplastic syndrome (MDS) and Chronic Myelomonocytic Leukemia~     (CMML).~   "
8577|NCT02944942|"~     General anesthetic technique plays a key role in most surgical procedures. This technique~     has some complications especially postoperative nausea/vomiting (PONV). This complication~     can lead to serious problems. Department of Anesthesiology has developed and implemented a~     PONV prophylaxis guideline for high risk PONV patients but PONV still remains.~   "
8578|NCT02944929|"~     The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections and~     usual physiotherapy should increase the proportion of patients who attain their Primary~     Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum~     Toxin Injections and conventional physiotherapy), in post stroke out-patients with~     spasticity.~   "
8579|NCT02944916|"~     The study descripted of efficacy of IryPump®R Set in term of success of the procedure at~     each irrigation~   "
8580|NCT02944903|"~     The investigators will conduct nationally representative survey in chest physicians in Egypt~     in 2016-2017. Self-administered questionnaire will be used to assess the physicians'~     knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening~     tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or~     sputum cytology in the past 12 months.~   "
8581|NCT02944890|"~     The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting~     balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment~     and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis~     compared with a product of the same category (SeQuent® Please).~   "
8582|NCT02944877|"~     This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using~     online social networks to scale peer community leader models to increase HIV prevention~     within African-American and Latino men who have sex with men. The peer community leader~     model, which teaches community popular opinion leaders about how to disseminate behavior~     changes messages throughout the community, has been proven to increase HIV prevention~     behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling~     these models. Primarily upper middle-class White populations used the Internet in its early~     years, however, Internet use within African-American and Latino households has recently~     increased dramatically, especially on online social networks such as Facebook.com. People~     using the Internet may be at the highest risk for contracting HIV and are using novel~     Internet approaches to find sex partners, such as through online social networks. This is~     the first study to examine the effectiveness of the HOPE social media intervention to~     increase HIV testing among at-risk groups in the United States.~   "
8583|NCT02944864|"~     To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
8584|NCT02944851|"~     The aim of this work is determine the more successful noninvasive method by comparison of~     two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that~     used in the detection of patients with blood loss.~      The works were completed in 6 months. The study was conducted at the blood donation center.~     Vital parameters were measured and recorded before making the voluntary blood~     donation.Following Masimo brand portable device fingers SpHb value was measured.Then IVC~     diameter of patients in the supine position were measured using ultrasonography. Then he~     left to donors return in routine blood donation programme. A unit (470ml) of blood were~     drawn from each donor. After the blood donation process measured and recorded the vital~     signs again. SpHb was measured noninvasively from finger again. Following these measurements~     were recorded again by measuring the diameter of IVC.~   "
8585|NCT02944838|"~     Senior Change Makers is an intergenerational intervention that compares two, 8-week~     programs: (1) an advocacy program wherein senior participants perform audits of their~     physical activity environments, identify an advocacy project, and advocate for improvements;~     and (2) a walking program designed to increase participant physical activity through~     education and guided walks. The investigators expect that the advocacy program will produce~     greater improvements in seniors' advocacy skills, confidence, and attitudes at 8 weeks.~   "
8588|NCT02944799|"~     A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who~     have been diagnosed with both rheumatoid arthritis (RA) and osteoporosis and have been~     treated with alendronate (ALN) for five years or more. Patients will be randomized to~     discontinuation or continuation of alendronate. Outcomes are measured using dual energy~     absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT)~     and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.~   "
8589|NCT02944786|"~     The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which~     includes patient education, person-centered health dialogues and pain/stress management),~     which is an adolescent-centered school health prevention program when adolescents have~     chronic pain. This is an intervention that has the hypothesis to support students to manage~     their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated~     health, quality of sleep, pain intensity and school attendance. The project aims to evaluate~     the intervention through qualitative and quantitative data collection by students and school~     nurses. The project has a hybrid design, which means that outcomes of the intervention and~     the evaluation of the implementation are taking place in the same data collection. The~     results of this project can be of great importance in the early detection of students with~     chronic pain and promote their confidence in their own ability to manage their symptoms.~   "
8590|NCT02944773|"~     Randomized crossover clinical trial in which is intended to assess the effect of facilitated~     tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale~     stress (ALPS-neo) be observed before, during and one hour after the weight, and compared~     with normal practice, without facilitated tucking device.~   "
8591|NCT02944760|"~     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney~     function and in its most advanced stage is called chronic renal failure. Although~     hemodialysis replace some kidney function, patients suffer some alterations characterized by~     uremic syndrome typically expressed by: motor neuropathy and/or autonomic neuropathy,~     cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thus, the~     functional capacity and ability to exercise presents diminished these patients. The aim of~     this study is to verify the acute effect of low level laser therapy on the functional~     capacity of these individuals.~      The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa~     Casa de Misericordia de Porto Alegre and the patients will be evaluated before and~     immediately after the application of laser therapy protocol. Before the protocol will be~     evaluated pain in the lower limbs, Borg scale, level of physical activity through the~     International Physical Activity Questionnaire (IPAQ) and blood collection will be held for~     later analysis parameters of biochemical oxidative stress and deoxyribonucleic acid (DNA)~     damage.~      The laser therapy protocol will be applied in 6 points in quadriceps and 4 points in the~     gastrocnemius, bilaterally. After application, will be held the 6-minute walk test, effort~     subjective perception by Borg scale, assessment of pain in the lower limbs with visual~     analog scale and a new blood sample for further analysis. Patients will be randomized in two~     groups. The intervention group (IG), which will be held laser therapy and placebo group~     (PG), where the laser therapy will be placebo mode applied. The application will take place~     with the Chattanooga device, with the laser diode cluster probe from the same manufacturer~     consisting of five diodes 850 nanometers (nm) and power output of 200 milliwatts (mW). It is~     irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally.~   "
8592|NCT02944747|"~     Background (brief):~        1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn~          mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all~          births and directly and indirectly contributed to 45% of all neonatal deaths.~          Gestational age (GA) is a key determinant of newborn survival and long-term impairment.~          Accurate estimation of GA facilitates timely provision of essential interventions to~          improve maternal and newborn outcomes.~        2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported~          information, recommended by the World Health Organization for estimating gestational~          age but has issues of recall mainly among poorer, less educated women and women with~          irregular menstruation, undiagnosed abortion, and spotting during early pregnancy.~          Several studies have noted that about 20-50% of women cannot accurately recall the date~          of LMP.~        3. Relevance: The goal of this study is to improve maternal and newborn outcomes by~          increasing the accuracy of gestational age estimation, using menstrual based dating,~          that is vital for providing timely and necessary obstetric and newborn care~          interventions. The study will determine the efficacy of three community based~          interventions using e-platform targeted to improve the recall and reporting of the date~          of last menstrual period in a rural resource poor setting. The innovative e-platform~          based interventions, if successful, can provide substantial evidence to scale-up in a~          low resource setting where e-Health and m-Health initiatives are proliferating with~          active support from all sectors in policy and implementation.~      Hypothesis :~        1. Implementation of conventional and e-platform based interventions will lead to a 30%~          improvement in recall of the date of the LMP in adolescent girls and married women in~          rural Bangladesh.~        2. Intervention triggered improvement in LMP date recall among pregnant women in rural~          Bangladesh will improve the accuracy in GA estimation.~      Objectives: The main objectives of the study are to:~        1. Determine whether a set of conventional and e-platform based interventions improve~          recall of the date of the LMP in adolescent girls and married women in rural~          Bangladesh.~        2. Determine whether intervention triggered improvement in LMP date recall in rural~          Bangladesh improves the accuracy in GA estimation or not~      Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial~     comparing three conventional and e-platform based interventions is proposed to improve~     recall of GA with a control arm. The trial will be conducted among adolescent girls and~     recently married women (within past two years) with no children or a single child in~     Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for~     recording date of LMP (ii) education and SMS based system for recording dates of LMP and~     reminders using mobile phone (normal) (iii) education and smart-phone based application for~     recording dates of LMP with an inbuilt reminder system.~      Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the~     recall of LMP date among enrolled participants in the three different intervention compared~     to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as~     compared to USG, following the intervention.~   "
8593|NCT02944734|"~     The purpose of this study is to explore the optimal dose of fixed-dose combination of~     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the~     combination therapy compared to each of the monotherapy in patients with essential~     hypertension.~   "
8594|NCT02944721|"~     The aim of the study is to establish the genetic, neurophysiological and psychological~     phenotype of the patients presenting a persistent neuropathic pain after surgery of the~     breast cancer, by comparing the neuropathic painful patients with the not painful and with~     the not neuropathic painful . This will be realized on a transverse cohort~     (Seintinellecohort) and confirmed on a forward-looking longitudinal cohort.~   "
8595|NCT02944708|"~     The purpose of this study is to examine the efficacy of maintenance chemotherapy for the~     treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms.~     Arm 1, control group, participants will receive only 4-8 cycles of conventional~     chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after~     conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy,~     participants will receive maintenance chemotherapy until disease progression or intolerable~     toxicities.~   "
8596|NCT02944695|"~     Both patient and staff safety are of major importance during the procedure of fibreoptic~     bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and~     accessories used as well as careful monitoring during the procedure.~   "
8917|NCT02940496|"~     The goal of this clinical research study is to learn about the safety and tolerability of~     pembrolizumab when given to patients with advanced liver cancer.~   "
8918|NCT02940483|"~     The goal of this clinical research study is to establish the safety of direct administration~     of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with~     recurrent posterior fossa ependymoma.~   "
8597|NCT02944682|"~     This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel~     distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda).~     Following a common protocol, each intervention site will recruit 800 pregnant women (aged~     18-34 years, <20 weeks gestation), and will randomly assign half their households to receive~     LPG stoves and a 30-month supply of LPG. Controls will receive the same cookstoves and LPG~     supply at the end of the study. The mother will be followed along with her child until the~     child is 2 years old. The researchers estimate that 25% of households will have a second,~     non-pregnant older adult woman (aged 35-64 years) who will also be enrolled at baseline and~     followed during the 30-month follow-up period. To optimize intervention use, the researchers~     will implement behavior change strategies informed by previous experiences and formative~     research in Year 1. This study will assess cookstove use, conduct repeated personal exposure~     assessments of household air pollution, and collect dried blood spots and urinary samples~     for biomarker analysis and biospecimen storage. The primary outcomes are low birthweight,~     pneumonia incidence, and linear growth in the child, and blood pressure in the older adult~     woman. Secondary outcomes include preterm birth and gross motor development in the child,~     maternal blood pressure during pregnancy, and endothelial function, respiratory impairment,~     carcinogenic metabolites, and quality of life in the older adult woman.~   "
8598|NCT02944669|"~     This study seeks to further evaluate the Multi-Tiered Training Program and to further~     explore the overall safety profile of the ReWalk Personal Device outside of the~     institutional setting under conditions of routine medical practice.~   "
8599|NCT02944656|"~     This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2~     hours preoperatively in conjunction with perioperative paracervical block for surgical~     abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce~     perioperative and postoperative pain associated with surgical abortion. Additionally, the~     researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and~     consumption of pain medication.~   "
8600|NCT02944643|"~     Chronic liver disease and cirrhosis pose a huge financial burden to the health care system.~     This includes the cost of medical care, employment, disability-related issues and reduced~     survival. Specifically, the complication of cirrhosis known as hepatic encephalopathy (HE)~     especially hinders quality of life, the performance of activities of daily living and the~     ability to drive a motor vehicle in affected subjects. The hidden burden to family members~     and caregivers of these subjects, however, has been all but ignored to date. Evaluation of~     family members and caregivers is essential. The burden of caring for someone with liver~     disease can result in added cost for health care for family members and caregivers and is~     typically not recognized. The importance of the burden to families and family members or~     caregivers resulting from other neurological diseases such as Alzheimer's has been well~     evaluated and specific strategies to educate and counsel family members and caregivers have~     been elaborated. This is important because as the findings of this study have emerged, we~     have found that both Veterans and non-Veterans with cirrhosis and HE have a poor quality of~     life, worse socio-economic status and place a significantly higher burden on their family~     members or caregivers than those without HE~   "
8601|NCT02944630|"~     The aim of this study is to determine the benefits of individual psychotherapy on quality of~     life for people with psoriasis receiving medical treatment versus a control group (awaiting~     group) treated with medical treatment, without psychotherapy.~   "
8602|NCT02944617|"~     This randomized clinical trial studies how well probiotic yogurt supplement works in~     reducing diarrhea in patients with kidney cancer that has spread from the primary site to~     other places in the body and that are being treated with sunitinib. Studying samples of~     blood and stool from patients who eat probiotic yogurt and those who avoid probiotic yogurt~     may help doctors plan better treatment.~   "
8603|NCT02944604|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil~     reduction.~   "
8604|NCT02944591|"~     The purpose of this research study is to investigate the potential benefits of participant~     use of a smartphone application (App) called COPD Co-Pilot™. When used by the participant,~     COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom~     detection may allow the pulmonary providers and nurses to respond with timely medical advice~     and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of~     hospitalizations, emergency department visits, and hospital readmissions. The study will~     also examine the financial impact of the COPD Co-Pilot™ program to determine whether costs~     of hospital stays, emergency department visits, and hospital readmissions differ when~     patients are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of~     this study is to measure patient satisfaction with use of COPD Co-Pilot™.~   "
8605|NCT02944578|"~     The purpose of this study is to see if curcumin can reverse a cervical precancerous state by~     looking at people who have the condition and intervening with a study drug or placebo (an~     inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP)~     which is a treatment procedure for removing cervical cancer. 40 women with high grade~     squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000~     mg capsule of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long~     washout period the participants will then undergo removal of the precancerous cells as~     recommended standard of care. Participants will have regular monthly visits for the duration~     of the study.~   "
8606|NCT02944565|"~     This phase II trial studies the side effects and how well daratumumab works in treating~     patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such~     as daratumumab, may interfere with the ability of tumor cells to grow and spread.~   "
8607|NCT02944552|"~     The test adopted the superiority design of multi center, randomized, double-blind, positive~     control drug, dose finding, using two simulation skills. The qualified subjects, according~     to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive~     drug control group, and received a treatment course of 8 weeks, all individuals were~     followed up for 4 weeks after drug withdrawal.~   "
9295|NCT02935556|"~     This study will recruit women with post partum pre-eclampsia and match them to controls~     without postpartum pre-eclampsia to identify an epigenetic signature that is specific to~     women with post partum pre-eclampsia to help characterize the underlying pathophysiology of~     post partum pre-eclampsia.~   "
8609|NCT02944526|"~     Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are~     randomly attributed to the control or study group. Both groups receive a series of 3~     suprascapular nerve blocks under ultrasound guidance with either 5ml saline or 5ml~     ropivacaine 2mg/ml ( ref) at 1 week interval. Testing consists of glenohumeral range of~     motion (ROM) (anterior elevation, lateral elevation, external and internal rotation)~     measured by goniometer, Constant score and visual analog scale (VAS) pain score. Evaluations~     are done immediately before and one hour after every suprascapular block and at 4 weeks~     after the third suprascapular block.~      All suprascapular nerve blocks are performed by one physician and the evaluations are done~     by a occupational therapist or MD experienced in glenohumeral function evaluations. All~     practitioners are blinded to the assigned group.~      All patients continue their pre-study treatment of physiotherapy and per os pain medication.~     Patients keep a record of analgesics and NSAID use during the trial. Drop-out rate is~     measured.~   "
8610|NCT02944513|"~     Research Objectives: This is a 1-year trial designed to gather information about the use of~     the Quell for persons with chronic musculoskeletal low back pain. The investigators~     hypothesize that those assigned to using the device will report reduced back pain compared~     with those in the control condition; with those using the device also showing improvement in~     sleep, mood, and level of activity. The investigators hypothesize that frequency of using~     the Quell (increased tolerability and adherence) will be correlated with greater reduction~     in pain. The investigators hypothesize that the device will be safe to use and will~     demonstrate a reduction in healthcare utilization (reduced clinic and ED visits). Finally,~     based on preliminary analyses limited by few subject numbers, the investigators will~     investigate whether certain individuals report greater benefit from using the Quell than~     others and, in particular, would predict that those with more intense and longer duration of~     pain will demonstrate most benefit.~   "
8611|NCT02944500|"~     The purpose of this protocol is to investigate the effect of treatment with the study drug~     Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and~     food intake.~   "
8612|NCT02944487|"~     The objectives of this study were to evaluate the safety and tolerability of lucerastat, and~     to determine its pharmacokinetic profile as single oral doses at different strengths.~   "
8613|NCT02944474|"~     The objectives of this study were to evaluate the safety and tolerability of lucerastat and~     to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect~     of food on the pharmacokinetics of lucerastat was explored following a single dose of 500~     mg.~   "
8614|NCT02944461|"~     To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the~     trunk~   "
8615|NCT02944448|"~     The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week~     Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period~     at the optimal dose level determined for each patient, and a 1-week Follow-up Period.~      Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio.~     Every patient will be started on a 1-mg dose of CR845 or matching placebo. During the~     post-randomization Titration-to-Effect period, the dose of study drug may be increased to~     2.5 mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but~     will not know whether they were randomization to active study drug or placebo. Approximately~     330 patients will be enrolled in this study.~   "
8616|NCT02944435|"~     This is a Phase 1, randomized, single-dose, 2-way crossover PK comparability study of CB-839~     administered as capsule and tablet formulations in healthy adult subjects.~   "
8617|NCT02944422|"~     This study is designed to determine the prevalence of oral habits among primary Egyptian~     school children in Cairo Governorate, Egypt.~   "
8618|NCT02944409|"~     This post-market clinical follow-up study intends to investigate long-term functionality of~     the VEGA System®. The design of the VEGA System® is meant to provide the patient with more~     knee mobility compared to their pre-operative state.The endpoint is the revision of at least~     one of the prosthesis components~   "
8619|NCT02944396|"~     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in~     combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or~     carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to~     veliparib in combination with platinum doublet chemotherapy results will improve progression~     free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in~     participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2~     portion).~   "
8620|NCT02944383|"~     A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy~     Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)~   "
8621|NCT02944370|"~     The investigator is pilot testing the feasibility and impact of a low-cost intervention that~     uses existing gymnasiums, and therefore has the potential to be replicated across the United~     States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key~     components, intended to overcome the major barriers to physical activity. First, it will~     assist people in finding others to play with, using the Pick-Up model of designating times~     to play and making those times known in the community. Second, it will overcome a lack of~     confidence in physical activity by including games of lower intensity for relatively unfit~     adults, then building up to moderate and vigorous games. Third, it will require team members~     of varying ages and genders to encourage intergenerational play. Fourth, it will use~     modified equipment (e.g., softer, lighter balls) and smaller game space to require less~     running, so that even relatively unfit people can feel confident participating. Fifth, it~     will be designed to be led by community volunteers, which will increase its disseminability.~      AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will~     come up with a list of games to play and pilot the games at a gymnasium. The investigators~     will observe the participants playing the games and have them complete a brief survey.~   "
8919|NCT02940470|"~     The primary objective of this pilot study is to determine the effect of weight loss on a~     wide range of biomarkers associated with risk of breast cancer recurrence in overweight and~     obese breast cancer survivors. We hypothesized that weight loss would result in a~     statistically significant improvement in biomarkers associated with risk of breast cancer~     recurrence.~   "
9349|NCT02934854|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of creatine~     deficiency syndromes from plasma~   "
8622|NCT02944357|"~     This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and~     AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and~     who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made~     from a person's tumor cells may help the body build an effective immune response to kill~     tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may~     make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.~   "
8623|NCT02944344|"~     The purpose of this study is to see whether patients with metastatic breast cancer, their~     caregivers, and their healthcare providers can improve in shared decision making (SDM) and~     preparedness around end of life (EOL) planning through participation in Reimagine's online~     Four Conversations™ program. The goal is to close clinical practice gaps and enhance the~     quality of care for patients with metastatic breast cancer through increased competence and~     performance of healthcare providers and healthcare systems.~   "
8624|NCT02944331|"~     The aim of this study is to evaluate the long-term effects of endovenous steam ablation~     (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated~     with EVSA.~   "
8625|NCT02944318|"~     School is a favorable environment for the development of actions aimed at healthy behavioral~     changes. This project proposes to evaluate the effectiveness of an intervention program on~     aspects of lifestyle, with a focus on physical activity (PA) and reducing sedentary~     behaviors, and the relationship of these factors with the academic performance of students~     in the school from Florianopolis, SC, Brazil.~      This is a randomized controlled intervention study enroling classes of 7th to 9th grade of~     fundamental education.~      The intervention program will last for one year (about ten months), with three focuses:~     training of teachers, educational and environmental changes to behavior change.~   "
8626|NCT02944305|"~     Failure in airway management is one of the most common anesthesia-related morbidity and~     mortality. Each individual airway assessment has limitation to predict difficult intubation.~   "
8627|NCT02944292|"~     The purpose of this study is to evaluate the effect of deepening of sedation on~     intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal~     hypertension.~   "
8628|NCT02944279|"~     The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with~     protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care~     unit (ICU) throughout the world. In recent years, much effort has been focused on the~     biological markers for their potential values to diagnose ARDS and outcomes.~      ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability,~     which subsequently caused an influx of neutrophils into the interstitium and alveolar space.~     It was reported that the aggregation, adhesion activation and release proteases of~     neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the~     most crucial protease generated in neutrophil azurophilic granules, plays an important role~     in various inflammations, especially the lung injury. The destructive action of HNE on~     almost all extracellular matrix influences cell signaling through cleavage of surface~     receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3.~     This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the~     investigators plan to conduct a cohort study with repeated measures to examine the~     diagnostic and prognostic value of HNE and PI3 for ARDS.~   "
8629|NCT02944266|"~     This is an observational study to evaluate the role of a Bed side Focus assessed~     Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of~     developing hypotension secondary to general anesthesia induction using the FATE parameters~     like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left~     ventricular end end diastolic area.~   "
8630|NCT02944253|"~     Two dietary approaches, very low energy diets (VLEDs) and ketogenic low carbohydrate diets~     (KLCDs), have the ability to suppress appetite. The suppression of appetite typically~     observed during these diets is believed (but not clinically proven) to be due to ketosis, a~     condition where circulating concentrations of ketone bodies are increased due to a higher~     production of ketones in the liver. Little is known about the potential mechanisms through~     which ketosis may lead to appetite suppression in VLEDs and KLCDs. A 'ketogenic diet'~     typically contains less than 50 grams carbohydrate per day, yet ketosis has been seen in~     subjects who consume diets with a carbohydrates ranging between 59-192 grams per day.~     Although an association between ketosis and appetite suppression has been established, the~     minimum level of ketosis and maximum carbohydrate intake that is still associated with~     appetite suppression remains unknown and should be explored. The ability to increase~     carbohydrate intake while maintaining a suppressed appetite will allow dieters to consume~     more carbohydrate-rich food that is beneficial for health without feeling more hungry. The~     aim of this study is, therefore, to identify the maximum carbohydrate intake that is still~     associated with appetite suppression in a low energy diet and to determine the impact of a~     higher carbohydrate intake on appetite suppression, body composition, and resting metabolic~     rate.~   "
8631|NCT02944227|"~     The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly~     dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in~     neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor)~     monotherapy.~   "
8632|NCT02944214|"~     The purpose of this study is to determine whether febuxostat and benzbromarone could protect~     renal function in chinese, and which one could be better.~   "
8633|NCT02944201|"~     This will be a single arm, window of opportunity study in men with treatment-naïve prostate~     cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to~     undergoing prostatectomy.~   "
8634|NCT02944188|"~     In this study, the investigators have compared the clinical outcomes of the laparoscopic and~     open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the~     treatment of right-sided colon cancer.~   "
8920|NCT02940457|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with~     transcranial direct current stimulation [tDCS]) during working memory training in seniors~     with mild cognitive impairments.The placebo-controlled double blinded study includes 50~     elderly patients which will be randomized into verum or sham tDCS.~   "
8635|NCT02944175|"~     Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse~     neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and~     have adverse effects associated with stimulation of muscarinic receptors. In addition,~     neostigmine cannot be used to reverse profound blockade.~      Anesthetics may exert their effects on various facets of cerebral function such as cerebral~     metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling,~     intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical~     activity. The net result of all these effects of the anaesthetic agents combined with their~     systemic effects may prove beneficial or detrimental to an already diseased brain.~      In neurosurgical patients, clear and rapid recovery is required to early assess the~     neurological status and to maintain the cerebral oxygenation and metabolism within the~     normal physiological values which may be saved by sugammadex.~   "
8636|NCT02944162|"~     The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in~     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem~     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
8637|NCT02944149|"~     The study is a non-inferiority randomized controlled trial (RCT) that aims to demonstrate~     that tubal ligations by minilaparotomy (ML) conducted by trained clinical officers (COs) are~     no less safe as compared to those conducted by assistant medical officers (AMOs) in~     Tanzania. Participants will be randomized in a one to one ratio to ML by a CO and ML by an~     AMO. In addition to the screening and enrollment/ML visit, there will be three scheduled~     follow-up visits at 3, 7 and 42 days post-surgery.~   "
8638|NCT02944136|"~     The proposed randomized controlled trial will test the efficacy of a stepped collaborative~     care intervention, versus enhanced usual care arm, to reduce depression of cancer~     caregivers. Biobehavioral factors will include assessment of changes in health behaviors and~     biomarkers of inflammation. The investigators will also include measures metabolic~     abnormalities and clinical markers of CVD. The investigators expect few cardiac events~     during the study period. The investigators will also measure other health outcomes but CVD~     risk factors will be the focus of the study.~   "
8639|NCT02944123|"~     East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or~     ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these~     regimens are more adequate for clinical practice in Korea is unclear. Therefore, the~     investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors~     in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary~     intervention (PCI).~   "
8640|NCT02944110|"~     Patients with diabetes are characterised not only by compromised insulin secretion and~     action, but also by elevated plasma levels of the 29-amino acid peptide hormone glucagon,~     which hitherto has been considered a pancreas-derived hormone (produced in and secreted from~     alpha cells in the islets of Langerhans). In patients with diabetes, circulating glucagon~     concentrations are elevated in the fasting state and fail to decrease appropriately or even~     increase in response to an oral glucose tolerance test (OGTT) or after ingestion of a mixed~     meal. Hyperglucagonaemia is known to be a potent stimulator of hepatic glucose output, and,~     thus, contributes significantly to the fasting and postprandial hyperglycaemia~     characterising patients with diabetes. Despite intense research over the years the~     mechanisms behind the elevated glucagon levels in diabetes is still not clear. Recently, the~     investigators showed that totally pancreatectomised patients also show a hyperglucagonaemic~     response during OGTT, a finding that suggests that the pancreas is not the only source of~     glucagon production in man.~      In the present project, the investigators wish to evaluate the impact of gastrointestinally~     derived glucagon secretion observed in totally pancreatectomised patients on postprandial~     glucose tolerance.~      The investigators hypothesise that antagonisation of glucagon signalling (from~     gastrointestinally derived glucagon) in totally pancreatectomised patients will improve or~     perhaps normalise the patients glucose tolerance during a 75g-OGTT. In order to test this~     hypothesis, the investigators wish to apply the potent and selective oral antagonist of the~     human glucagon receptor LY2409021 and placebo, respectively.~      The study is a randomised, placebo-controlled, double-blinded, cross-over study.~      10 healthy persons and 10 pancreatectomized patients (i.e. patients who have had their~     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected~     to two experimental days with LY2409021 and placebo, respectively, on which they will~     undergo an OGTT followed by a fasting period and finished off with an ad libitum meal.~   "
8641|NCT02944097|"~     To enhance the oral bioavailability of the antioxidants trans-resveratrol and~     trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was~     incorporated into micelles. A single dose, single blind, two arms crossover trial was~     conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake~     of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and~     compared between formulations. Tolerability of the dose was also controlled by safety~     parameters in plasma.~   "
8642|NCT02944084|"~     The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice~     bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation~     into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were~     investigated. The influence of the type of preparation (with water vs. milk) of porridge on~     the bioavailability of the bioactive compounds was compared. The study followed a single~     dose (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week~     washout periods. Plasma and urine samples were collected at intervals up to 24 h after~     intake.~   "
8643|NCT02944071|"~     This clinical study is a prospective, non-randomized, multicenter study to demonstrate the~     acceptable safety and performance of angioplasty with the Ranger DCB in native~     femoropopliteal artery lesions. It is intended that all patients with qualifying lesions~     would be considered for enrollment and treated with the Ranger DCB catheter. Approximately~     123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be~     treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to~     participate.~   "
8644|NCT02944058|"~     The purpose of the project is to compare the management of 3 and 4 part proximal humerus~     fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail~     (Multiloc) in light of complications, radiological, economical, functional and clinical~     outcome.~   "
8683|NCT02943551|"~     Unwarranted use of antibiotics for pediatric acute respiratory tract infections (ARTIs) and~     use of second-line, broad spectrum antibiotics for bacterial ARTIs has contributed to the~     rapid development of resistance in many strains of bacteria. Provider-parent communication~     during pediatric visits for ARTIs strongly influence antibiotic prescribing rates. The~     overall goal of this study is to develop and test a distance learning quality improvement~     (QI) program called Dialogue Around Respiratory Illness Treatment - DART. The DART program~     aims to improve provider communication practices and treatment decisions during pediatric~     ARTI visits, with the ultimate goal being to decrease rates of antibiotic prescribing for~     these illnesses in children.~   "
8645|NCT02944045|"~     Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients.~     Mortality remains high for those patients with comorbidities (50% for patients with the most~     severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in~     non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with~     PcP has been associated with decreased mortality but in non-HIV patients, adjunctive~     steroids remains controversy. Some retrospective studies in that field did not find any~     beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the~     studies were retrospective, non randomised studies including various underlying disease and~     severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading~     difficult to interpret all the results.~      The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV~     immunocompromised patients with a double blinded randomised clinical trials comparing~     adjunctive steroids to placebo.~   "
8646|NCT02944032|"~     Th main objective of the study is to assess the efficacy of a home-based, computerized~     cognitive training (CT) program, called CogmedRM, targeted to improve working memory in~     children with NF1 and working memory difficulties.This is a Phase II randomized parallel~     group controlled clinical trial comparing two interventions on cognitive outcomes.~     Participants will be stratified by stimulant medication use and randomized equally between~     the two interventions within stratum. Participants will be in the study for to 11 weeks.~   "
8647|NCT02944019|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed~     this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver~     adverse events, all-cause mortality and other drug related adverse events) of edoxaban use~     in patients with NVAF who were not preselected.~   "
8648|NCT02944006|"~     This study aims to establish radiomics database for pancreas cancer from multiparametric MRI~     including DCE-MRI obtained by using incoherent undersampling and radial acquisition for~     clinical staging as well as quantitative analysis.~   "
8649|NCT02943993|"~     According to current guidelines, duration of anticoagulant treatment after a venous~     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated~     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are~     limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013;~     369:1406-15).~      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic~     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality~     and other drug related adverse events) of extended treatment with edoxaban up to 18 months~     in an unselected patient population in routine clinical practice.~   "
8650|NCT02943980|"~     A randomized controlled prospective study of laryngoscopy and evaluation of the~     Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the~     McGrath® Mac videolaryngoscope.~   "
8651|NCT02943967|"~     The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and~     photorefractive keratectomy for refractive correction in patients with bilateral asymmetric~     topography.~   "
8652|NCT02943954|"~     Although current guidelines recommend fractional flow reserve (FFR) to identify~     haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia~     is not available (Class I, Level of Evidence: A), no published study has assessed the~     usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation~     myocardial infarction (STEMI) patients with multi-vessel disease (MVD).~      The main objective of this study is to determine whether, in STEMI patients with MVD~     amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular~     outcomes, compared with the current practice of angiography- guided PCI, by improving the~     appropriateness of revascularisations by assessing the relevance of non-culprit lesions in~     the context of STEMI with multivessel coronary artery disease.~      The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided~     strategy compared to the angiography-guided strategy.~   "
8653|NCT02943941|"~     The purpose of this study is to understand how the pressure in the pulmonary artery changes~     under different conditions of posture, respiration and exertion.~   "
8654|NCT02943928|"~     Visual laryngoscope combined with chest CT in double lumen endotracheal tube accurate~     positioning~   "
8655|NCT02943915|"~     A randomized, controlled trial comparing exoskeleton gait training with standard gait~     training or no gait training in community-dwelling participants with chronic incomplete~     spinal cord injury~   "
8656|NCT02943902|"~     This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal~     Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at~     either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule),~     and compare this immune response to those who receive a two dose primary series (at 6 and 14~     weeks of age) and booster dose at 9-months (2+1 schedule).~   "
8657|NCT02943889|"~     Chronic liver disease end by liver cirrhosis and increases the risk of cancer development.~     Chronic liver disease in Egypt is recognized as a serious health problem affecting greater~     than (20 %) of the population, where the main cause is chronic infection.~      Liver transplantation is still the standard treatment for advanced decompensated liver~     cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is~     a concerted effort around the world to develop regenerative and alternative therapies, so,~     stem cell-based therapies are emerging as new alternatives to liver transplantation for~     end-stage liver pathologies.~   "
8684|NCT02943538|"~     Pragmatic clinical trial, randomized, controlled parallel, 3 group (group technology~     platform, call group and control group), developed in the monograph Reference Unit of~     Inflammatory Bowel Disease Valencia (single-center).~   "
8759|NCT02942563|"~     The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal~     cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them~     even more severer. A number of pilot studies had shown high rate of complete resection after~     neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological~     complete response (pCR), which was associated with overall survival (OS). Here, the~     investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin,~     Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent~     chemoradiation and to improve the ratio of pCR further.~   "
8658|NCT02943876|"~     Major depressive episode (MDE) is one of the most prevalent and disabling form of mental~     illness in the general population. Despite increased mental health services and~     antidepressants use in the past 10 years, there has been no measurable change in the~     prevalence of MDE in the Canadian general population, which motivates the search for~     additional strategies for reducing the burden of MDE. One strategy that has been successful~     in the fields of oncology, cardiology and diabetes is early identification and prevention -~     identifying people who are at high risk and taking preventive actions to lower the risk so~     as to prevent symptoms from progressing into a MDE. As multivariable risk prediction~     algorithms are used to estimate an individual's risk (probability) of future disease, they~     can play an important role in the process of early identification. The proposed study stems~     from a project funded by an operating grant from the Canadian Institutes of Health Research~     (CIHR). With the CIHR support, the team developed and validated sex-specific prediction~     algorithms for MDE. As risk prediction is at very early stage in psychiatry and MDE is still~     highly stigmatized, to facilitate the future implementation of the developed risk prediction~     algorithms, the proposed study seeks to answer the following research questions: (1) Does~     disclosure of personalized depression risk information promote high-risk individuals to take~     preventive actions? (2) Will disclosure of personalized depression risk information~     negatively affect high-risk people's mental health status in terms of increased~     psychological distress? To answer the questions, the investigators planned to conduct a~     randomized controlled trial (RCT) with an embedded qualitative component. The proposed study~     will develop an evidence base for guiding the disclosure of personalized risk information~     and understanding the process of risk communication and consumer empowerment, contributing~     to the advancement of early prevention of MDE in Canada.~   "
8659|NCT02943863|"~     High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently~     introduced for bedside care. It has been shown to be associated with reduced risks of~     tracheal intubation rates and mortality in adult hypoxic patients.~      The mechanisms of the effects of HFNC are thought to be related to the favorable effects of~     the heated and humidified gas, the high-flow rate used to minimize the entrainment of room~     air, and an increase in the ventilation efficiency, including the elimination of~     nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements~     in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation~     in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However,~     how regional ventilation is affected during HFNC in comparison with conventional NC remains~     unknown.~      Because PEEP in mechanically ventilated patients improves the regional homogeneity of~     ventilation, investigators postulated that HFNC via PEEP effects would result in more~     homogeneous regional distributions in the ventilation changes. Investigators therefore~     assessed global and regional ventilation in patients with hypoxia receiving care via HFNC~     using electric impedance tomography and compared these results with conventional nasal~     cannula.~   "
8660|NCT02943850|"~     The investigator is examining the safety of transplanting cells that have been engineered to~     produce a growth factor into the spinal cord of patients with Amyotrophic Lateral Sclerosis~     (ALS). The cells are called neural progenitor cells, which are a type of stem cell that can~     become several different types of cells in the nervous system. These cells have been derived~     to specifically become astrocytes, which is a type of neuronal cell. The growth factor is~     called glial cell line-derived neurotrophic factor, or GDNF. GDNF is a protein that promotes~     the survival of many types of neuronal cells. Therefore, the cells are called~     CNS10-NPC-GDNF. The investigational treatment has been tested in animals, but it has not~     yet been tested in people. In this study, we want to learn if CNS10-NPC-GDNF cells are safe~     to transplant into the spinal cords of people.~   "
8661|NCT02943837|"~     Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve~     clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently~     considered the standard method for sampling SET, its diagnostic yield is generally~     suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate~     histology obtained.~      Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.~   "
8662|NCT02943824|"~     The proposed, mono-institutional, randomized-controlled trial aims to determine whether the~     dosimetric outcomes following prostate Low-Dose-Rate (LDR) brachytherapy, planned using a~     novel machine learning (ML-LDR) algorithm, are equivalent to manual treatment planning~     techniques. Forty-two patients with low-to-intermediate-risk prostate cancer will be planned~     using ML-LDR and expert manual treatment planning over the course of the 12-month study.~     Expert radiation oncology (RO) physicians will then evaluate and modify blinded, randomized~     plans prior to implantation in patients. Planning time, pre-operative dosimetry, and plan~     modifications will be assessed before treatment, and post-operative dosimetry will be~     evaluated 1-month following the implant, respectively.~   "
8663|NCT02943811|"~     The investigators sought to retrospectively assess whether the use of a intrauterine device~     to manipulate the uterus does affect the long-term oncologic outcomes of patients operated~     by laparoscopy for endometrial cancer~   "
8664|NCT02943798|"~     The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus~     carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced~     pulmonary large cell neuroendocrine carcinoma.~   "
8665|NCT02943785|"~     When the upper chambers of a person's heart receive irregular electrical signals it causes~     abnormal rhythm in the heart beat. This is called atrial fibrillation.~      Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients~     also get new heart valves using a catheter.~      Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is~     considered the standard care. This study will see how edoxaban compares to VKA in patients~     who got a new heart valve by using a catheter.~      The study will compare the two drugs for up to three years after heart valve replacement,~     looking at the drug's overall side effects (called adverse events) and major bleeding.~   "
8666|NCT02943772|"~     The investigators propose to examine the effect of local cooling of testis in participants~     with acute epididymitis or orchiepididymitis on participants reported pain level and~     analgetics consumption.~   "
8667|NCT02943759|"~     The trial is to test the resolution of pain, swelling and other signs of periapical~     infection and the antimicrobial efficacy when using the neem leaf extract compared to~     chlorhexidine as root canal irrigant in Pulpectomy treatment for children.~   "
8708|NCT02943226|"~     The purpose of this research study is to compare two types of catheters used for infusing~     the contrast dye necessary for viewing internal organs during computed tomography (CT)~     scanning. The standard catheter, which has one hole from which contrast dye enters veins,~     will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three~     holes for diffusing dye into veins. The purpose of this study is to determine which catheter~     type gives the best image.~   "
12431|NCT02894489|"~     Our study is aimed to observe the long termed effect of contact lens wear on ocular surface,~     especially focused on visual function and ocular inflammation mediators.~   "
8668|NCT02943746|"~     While new innovations in the care of extremely premature infants have led to decreased~     morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in~     the postnatal period influences neurodevelopmental and growth outcomes.~      This proposed study will challenge current nutritional regimens for infants < 1000 g birth~     weight (BW) by providing an exclusive human milk based diet with a higher amount of protein~     based on individual caloric and protein analysis of human milk utilizing targeted~     fortification. The investigators will evaluate the effects of a high versus standard protein~     enteral diet on growth and body composition in infants < 1000 g BW.~      There are no published studies evaluating the effect of an exclusive human milk protein diet~     on body composition in premature infants. Research has shown that infants who receive this~     diet achieve growth at targeted standards but body composition has not been evaluated. As an~     all human milk diet is well tolerated and associated with improved outcomes in the highest~     risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human~     milk diet and the possible positive changes in body composition, specifically lean mass, in~     these infants.~      Results from this proposed study will immediately influence current nutritional practices~     and will provide landmark information regarding targeted fortification with provision of~     adequate protein providing the most optimal body composition in the most fragile and~     vulnerable infants.~   "
8669|NCT02943733|"~     The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose~     (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to~     evaluate the safety profile of this drug combination.~   "
8670|NCT02943720|"~     A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and~     Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping~     Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic~     Rhinitis/Rhinoconjunctivitis~   "
8671|NCT02943707|"~     This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi)~     therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while~     control group will only receive drugs therapy.~   "
8672|NCT02943694|"~     Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total~     mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer~     patients have been considerably improved. However, anatomical limitations in pelvic space~     hinder the further optimization of surgical treatment Thus, the natural orifice transluminal~     endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal~     total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception~     and single port technique, has been prevailing both in West and East nations, with or~     without the abdominal laparoscopic assistance. Up to date, there are various kinds of~     instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws~     in each instrument remains according to the feedbacks. This study is therefore designed to~     clinically evaluate the feasibility and safety of the new instruments specifically for TaTME~     (CS-Compact, GelPoint pathway).~   "
8673|NCT02943681|"~     This study evaluates the non-specific effects on child mortality and morbidity of a second~     dose of measles in the second year of life. Half of the study participants will receive a~     second dose of measles vaccine at 18 months of age while the other half will receive a~     second dose of measles by 4 years of age or at the end of the study.~   "
8674|NCT02943668|"~     This phase II trial studies how well deferasirox works in treating patients with very low,~     low, or intermediate-risk anemia or myelodysplastic syndrome that depends on red blood cell~     transfusions. Deferasirox may treat too much iron in the blood caused by blood transfusions.~   "
8675|NCT02943655|"~     Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow,~     frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual~     abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml~     or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic~     disease.~   "
8676|NCT02943642|"~     This study evaluates the effectiveness — as judged by complete response — of a single~     four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza~     (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient~     eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid~     disease or a prior bone marrow / HSCT transplant.~   "
8677|NCT02943629|"~     The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with~     a P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of~     Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.~   "
8678|NCT02943616|"~     The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center,~     single-arm, non-randomized trial designed to observe Absorb continued safety during~     commercial use in real world settings.~   "
8679|NCT02943603|"~     This research study is being down to find what, effects, good and/or bad, adding~     Pembrolizumab to standard chemotherapy mFOLFOX before and after surgery have on the patient~     and the patient's cancer.~   "
8680|NCT02943590|"~     This research study will test whether atorvastatin, a drug commonly prescribed for reducing~     cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin~     is from a family of medications that are commonly called statins~   "
8681|NCT02943577|"~     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams~     (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major~     depressive disorder (MDD) who have a partial response to ADT.~   "
8682|NCT02943564|"~     This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel,~     225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy~     (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.~   "
8744|NCT02942758|"~     Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60~     years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety~     Run-In Phase; randomized Phase II, open-label~        -  Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for~          the randomized phase II is defined.~        -  Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm:~          standard-dose azacitidine; in both arms patients can receive further cycles (with no~          limit to the number given) as long as clinically appropriate~   "
8685|NCT02943525|"~     Vaginal packing is used routinely following vaginal reconstructive surgery, however, no~     recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite~     little data to support the practice, purported benefits better positioning and fixation of~     the mesh, improving incorporation of the mesh by its fixation and reduced blood loss.~     Patients often complain of discomfort associated with the packing or its removal. The aim of~     this randomized controlled is to compare the subjective impressions of pain and bother in~     women undergoing laparoscopic sacrocolpopexy treated with and without packing. The~     investigators also aim to assess differences in postoperative bacteriuria, urine retention~     and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at~     one year after the surgery in those with and without packing.~   "
8686|NCT02943512|"~     This study is to assess if subjects receiving a clinically indicated implanted cardiac~     pacemaker or defibrillator can be safely discharge home the same day of the procedure.~   "
8687|NCT02943499|"~     The purpose of this study is to understand brain mechanisms of app-based mindfulness~     training in smokers ages 21 to 65 years.~   "
8688|NCT02943486|"~     The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal~     cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2)~     in adults. A third of the participants will receive dac-MSCs and Triticum vulgare~     (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and~     the last third only Fitosimoline. This study will be a randomized, blind, and parallel and~     controlled-group trial.~   "
8689|NCT02943473|"~     The purpose of this research study is to test whether the drug ibrutinib (trademark name:~     IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who~     currently have smoldering myeloma. The researchers conducting this trial) have reason to~     believe that ibrutinib can delay the development of multiple myeloma, thus giving people who~     currently have smoldering myeloma a longer period of time when they feel healthy and well.~      Smoldering myeloma is an abnormal condition that is considered to be an early phase of the~     disease multiple myeloma. In this disorder, there is an abnormal growth of plasma cells,~     which is a type of blood cell found in the bone marrow. This growth is not as severe in~     people with smoldering myeloma as it is in multiple myeloma, so people with smoldering~     myeloma do not have any symptoms and tend to feel well. However, they have a higher risk of~     developing multiple myeloma than people in the general population.~      Some people with smoldering myeloma are at an especially high risk of developing myeloma -~     50% of these people will develop multiple myeloma 2 years after they are diagnosed with~     smoldering myeloma. The investigators identify these people by looking at the amount of~     myeloma in the bone marrow (called bone marrow plasma cell percentage) and the amount of~     myeloma protein (called serum protein electrophoresis and serum free light chain assay)~     in the blood. To be considered high risk, individuals must have highly abnormal levels for~     these tests.~      Based upon current guidelines, people with smoldering myeloma do not require any treatment.~     However, known is that many of these people will develop multiple myeloma in the near~     future. Currently there have been no proven and effective way of preventing these people~     from developing multiple myeloma, which remains an incurable disease.~   "
8690|NCT02943460|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     adults with primary sclerosing cholangitis (PSC).~   "
8691|NCT02943447|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     adults with primary biliary cholangitis (PBC).~   "
8692|NCT02943434|"~     This study will examine differences in diet-induced thermogenesis (DIT) between a meal made~     of processed ingredients and an equivalent, isocaloric meal made of whole ingredients. For~     the purpose of this study processed foods (PFs) will be considered those that are purchased~     in a state that is modified from their whole food (WF) counterpart (e.g. shell eggs compared~     to powdered eggs). Research has shown that less energy is expended to digest processed foods~     than whole foods, which confers an advantage to processed foods in terms of caloric~     efficiency, but a disadvantage in terms of energy balance and weight loss. A 2010 study~     showed that subjects expended approximately 10% less energy to digest sandwiches made of~     white bread and cheese product compared to sandwiches made of whole grain bread and cheddar~     cheese. The intent of this study is to enhance those results and improve upon the study~     design by constructing meals to be more similar in the makeup of individual ingredients,~     making ingredient processing a more isolated variable. Subjects will be healthy CWU male~     students with a body mass index of 18.5 - 24.9 kg/m2. Metabolism will be assessed by~     repeated measurements of resting energy expenditure via indirect calorimetry. Measurements~     of baseline metabolism will be made; subjects will then be provided one of two meals, both~     comprised of rice, green beans, and eggs cooked in canola oil and equivalent but differing~     in processing status (e.g. brown rice and white rice, fresh cooked green beans and canned~     green beans, etc). Hourly metabolic measurements will be made post-meal for 6 hours. During~     this time subjects will be asked to minimize non-DIT deviations in metabolism; e.g. those~     due to physical activity, excitement level, etc. The procedure will be repeated one week~     later with the other meal so that changes in DIT can be assessed on a subject-by-subject~     basis. The results of this study will be assessed in the lens of weight loss, specifically~     dietary choices that affect energy balance. It is possible that consuming a diet that~     includes more whole foods (versus processed foods) would be beneficial to the attainment of~     a healthy body weight - either through potential weight loss or weight maintenance.~   "
8693|NCT02943421|"~     Placenta accreta is considered a severe pregnancy complication that may be associated with~     massive and potentially life-threatening intrapartum and postpartum hemorrhage.~     Life-threatening bleeding is the most common complication to be associated with this~     condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which~     leads to significant postoperative morbidity and death.~   "
8694|NCT02943408|"~     Recent Veterans of the OIF/OEF/OND conflicts are presenting in VA care with high rates of:~     PTSD, depression, anxiety, and alcohol abuse, reporting significant difficulties with~     community reintegration, and dropping out of mental health care at high rates. Surveys of~     recent Veterans show that Veterans want the VA to provide mental health care tailored to~     their concerns and reintegration priorities. The VA is committed to providing personalized,~     proactive, patient centered care (PCC); but little research or intervention development has~     been done on PCC in mental health care settings and preliminary research indicates Veterans~     may lack the skills and knowledge to be active partners in PCC. This study aims to examine~     PCC behaviors in VA mental health care and, informed by this data, develop a brief patient~     centered mental health intervention that will help recent Veterans take the lead in their~     care personalization and support their functional recovery. Results from this study will~     demonstrate the acceptability, feasibility, and preliminary efficacy of this intervention.~   "
8695|NCT02943395|"~     Light curing cements used for laminate veneers may be not totally cured in certain areas, so~     dual cured resin cements may solve this problem yet the dual cured cements containing amines~     cause yellowish discoloration of the veneers after time.~      A new dual cured cement which is amine free is introduced so the investigators have to try~     it clinically using parallel groups in randomized clinical trial.~   "
8696|NCT02943382|"~     Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes~     of dry eye are multifactorial, with the most common cause of evaporative dry eye disease~     being meibomian gland dysfunction (MGD).~      Fingerprick autologous blood (FAB) is a novel method which uses a patient's own blood to~     treat dry eye conditions.~   "
10242|NCT02923180|"~     This study evaluates the safety, anti-tumor effect, and immunogenicity of Enoblituzumab~     given before radical prostatectomy. All patients will receive Enoblituzumab for 6 weekly~     doses beginning 50 days prior to radical prostatectomy.~   "
8697|NCT02943369|"~     Platelets and thrombus formation play a key role in the pathogenesis of acute coronary~     artery occlusion and subsequent myocardial infarction. Apart from mechanically opening the~     occluded artery with angioplasty, adjunctive antiplatelet treatment is of utmost importance.~     However, orally administered antiplatelet agents exhibit a delay in their onset of action in~     the setting of acute myocardial infarction and angioplasty is mostly performed without~     adequate platelet inhibition. Cangrelor is an intravenous antiplatelet agent which can~     provide almost immediate strong platelet inhibition. The investigators aim to compare a~     strategy of cangrelor administered on top of ticagrelor-an oral antiplatelet agent- vs~     ticagrelor alone, on their efficacy to inhibit platelet function in the early hours of an~     acute myocardial infarction.~   "
8698|NCT02943356|"~     Observational study to evaluate the effect of Tadalafil 5mg once daily on Erectile~     Dysfunction and QOL in Andropause patients with Erectile Dysfunction.~      Patients will be observed for 8weeks.~   "
8699|NCT02943343|"~     The China Pulmonary Thromboembolism Registry Study (CURES) is a prospective multicenter~     registry project initiated in January 2008 and consisting in obtaining an extensive data~     registry of consecutive patients with pulmonary thromboembolism.~        -  The main objective of this registry study is to help physicians to improve their~          knowledge on the natural history of pulmonary thromboembolism, including~          epidemiological characteristics, personal history, risk factors, clinical~          manifestations, diagnostic methods, therapeutic regimens, clinical outcomes, prognosis,~          etc..~        -  Secondly, this study is also aimed to find some useful information for some patients~          who are usually not recruited in randomized clinical trials (pregnant women, elderly~          patients, disseminated cancer, severe renal insufficiency, patients with~          contraindications to anticoagulation therapy, extreme body weight, etc).~        -  Thirdly, the ultimate purpose of CURES study is decreasing mortality, frequency of~          thromboembolic recurrences as well as bleeding complications and arterial events.~   "
8700|NCT02943330|"~     Depression is one of the most common psychiatric diseases, with prevalence estimates ranging~     from 5% to 20%. Depression is now recognized as a brain disease; it can be managed and~     treated effectively with a wide range of options, but its biological basis is still far from~     clear. Studies of monozygotic and dizygotic twin pairs suggest polygenic inheritance, with~     an overall heritability estimate between 40% and 70 %. Gene-environment interaction has been~     recognized for a long time in the pathophysiology of depression, and its best biological~     substratum at present is represented by the serotonin transporter (5-HTT) gene. It would be~     interesting to study association between the novel allelic variants or at least the~     triallelic 5-HTTLPR polymorphism and depression. Depression is common in patients with~     end-stage renal disease and to occur in about 20% to 30% of hemodialysis patients.~     Interferon-induced depression is estimated up to 50% among patients with hepatitis C.~     Several sets of observations support the supposition that cytokines, and proinflammatory~     cytokines in particular, are involved in depressive disorders. Depression sufferers have~     been reported to have elevated blood levels of interleukin 1 (IL-1), IL-6 and tumor necrosis~     factor α (TNF-α).~   "
8701|NCT02943317|"~     This is a Phase 1/1b, open-label, multicenter, dose-escalation and dose expansion trial to~     evaluate the safety, efficacy, PK and PD of defactinib (VS-6063) in combination with~     avelumab in epithelial ovarian cancer.~   "
8702|NCT02943304|"~     This prospective cohort study will determine the natural history of fetal exposure to Zika~     virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment~     outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV~     (blood and urine) and serologic test specific for ZIKV. Neonates will be classified~     according to trimester of infection and as exposed and unexposed to ZIKV.~   "
8703|NCT02943291|"~     The primary aim of this trial is to investigate adipose tissue function in women with and~     without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young~     women. The pathogenesis behind PCOS is complex and only partly understood, and deeper~     mechanistic insight is needed. Insulin resistance is a central feature of PCOS, and recent~     studies have suggested that this is linked to aberrant adipose tissue function. Exercise~     training has been found to improve the symptoms in PCOS, but we need more knowledge about~     why. While processes involved in skeletal muscle oxidative remodeling are well described, it~     is to a large extent unknown whether the oxidative capacity of human adipose tissue is~     modified by endurance training. The women included in this study will be matched (for body~     mass index, body weight, and age) to participants in another study. This will enable the~     investigators to do a comparison between cases (women with PCOS) and controls (women without~     PCOS) at baseline, and to assess the responses to exercise training in adipose tissue.~   "
8704|NCT02943278|"~     In this study we are testing 2 different forms of sleep therapy to help people with insomnia~     and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to~     see how these sleep therapies help insomnia in people with depression.~   "
8705|NCT02943265|"~     Nearly 70% of people living with cancer are complex patients with multiple chronic~     conditions who must deal not only with effects of their cancer but also continuing diseases~     such as diabetes, depression, hypertension, or heart disease. Care coordination strategies~     shown to be effective in improving outcomes for common medical conditions seen in primary~     care include: systematic transitions for patients to and from specialty care; intensive case~     management; and a team-based approach to comprehensive care. Despite an Institute of~     Medicine report suggesting these strategies as potential ways to improve care for cancer~     survivors, their implementation has not yet been evaluated for cancer survivors. Parkland~     Health and Hospital Systems will be implementing care coordinator strategies as part of as~     quality assurance/quality improvement activities, which Aim 2 and Aim 3 (research~     components) will evaluate. This protocol has been organized to reflect this distinction~     between the aims. The investigators expect no more than 1500 patients to be included in~     these study aims.~   "
8706|NCT02943252|"~     This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial~     evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced~     (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.~   "
8707|NCT02943239|"~     Assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health~     postmenopausal women.~   "
12450|NCT02894242|"~     This investigation is designed to evaluate the performance as well as the patients overall~     acceptance of the mask.~   "
8709|NCT02943213|"~     Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of~     Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its~     similarity to the RLD.~      The aim of this pilot study is to investigate intrasubject variability in the~     bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.~      Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response~     curve and a wide safety margin. This will then allow for the modification of bioequivalence~     acceptance criteria in future pivotal studies which will reduce the number of participants~     required whilst still maintaining assurance of safety and efficacy.~      Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product:~     N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine;~     7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 -~     125.00%~   "
8710|NCT02943200|"~     The purpose of the study is to determine the prevalence of malocclusion among a group of~     Egyptian children with digit sucking aged 3 to 6 years.~   "
8711|NCT02943187|"~     The purpose of this investigation is to conduct a series of case studies on the impact of a~     novel functional medicine approach to improving cognitive skills, brain structure, and daily~     functioning for participants with Mild Cognitive Impairment (MCI).~   "
8712|NCT02943174|"~     This investigation aims to apply and test the feasibility of an acceptance, mindfulness and~     compassionate-based intervention structured for cancer patients. MIND programme for cancer~     thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups~     at an Oncology Service at the Coimbra's University Hospital. For each week participants have~     assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase~     participants' physical and psychosocial quality of life, and attenuate depressed mood and~     anxiety. Additionally, this study also intends to explore whether the reduction of~     depression and anxiety symptoms will promote better results in the medical treatments of the~     participants, and influence the course and prognosis of the illness.~   "
8713|NCT02943161|"~     This study will evaluate whether treatment with L-citrulline, which is an amino acid found~     in some foods, can increase levels of L-arginine and thereby restore the concentration of~     nitric oxide (NO) in the airways.~   "
8714|NCT02943148|"~     Several methods have been used to predict adhesions after abdominal operations.~     High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were~     the methods that were evaluated in the English literature for this study. Estimating the~     likelihood of adhesions and related complications after prior surgery and assessing the~     severity of adhesion formation after surgery is not easy. Anticipating adhesions is very~     important to preventing complications by ensuring that the necessary preoperative~     preparations are in place and/or that appropriate cases are referred to a tertiary center.~   "
8715|NCT02943135|"~     Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to~     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions~     including measuring uterine depth, inserting the insertion tube, and removing the tube; and~     placement of the device in the uterus.~   "
8716|NCT02943122|"~     Preeclamptic pregnancy is associated with alterations in the left ventricular structure and~     function and elevation of cardiovascular biomarkers. The alterations are still persistent~     several months after delivery and are more clearly observed in early-onset and severe~     Pre-eclampsia~   "
8717|NCT02943109|"~     A large-scale randomized control trial (RCT) of the impact and use of an inpatient~     tablet-based patient portal embedded in a larger mixed methods study to examine changes in~     patient experiences and outcomes, and subsequent ambulatory patient portal usage.~   "
8718|NCT02943096|"~     The goal of this proposal is to conduct the first pilot study of whether consuming flavanol~     supplements will augment the cognitive and mood benefits of antidepressant medication in~     older adults with Late LifeDepression (LLD). Flavanols represent a specific group of plant~     derived nutrients that are found in cocoa beans, grapes, tea, berries and various other~     fruits and vegetables. The specific flavanols investigated in this study come from cocoa.~     Currently available treatments for LLD (i.e., antidepressant medication) are limited in~     efficacy, especially in individuals who also suffer from cognitive impairment. Recent~     studies performed at Columbia and elsewhere suggest that flavanols may induce beneficial~     brain changes that support cognitive functioning and elevate mood, but their precise~     clinical effects in older adults with combined depression and cognitive impairment remain to~     be evaluated. For this study, the investigators plan to recruit 50 adults aged ≥60 years who~     have Major Depressive Disorder, meet a minimum depressive symptom threshold despite~     currently receiving an adequate trial of an antidepressant, and have a significant cognitive~     complaints without a diagnosis of dementia. Subjects will be randomized to receive 8 weeks~     of augmentation treatment with flavanol capsules (in addition to continuing their~     antidepressant) vs. capsules not containing flavanols. Pre- and post-treatment MRI scanning~     of the brain will be conducted, and comprehensive pre- and post-treatment neuropsychological~     assessment will be performed. Results from this project will allow the investigators to~     evaluate a novel therapeutic approach to LLD, which could have large public health~     ramifications given the prevalence, frequent treatment resistance, and chronicity~     characteristic of LLD.~   "
8757|NCT02942589|"~     The purpose of this study is to test whether food intake in response to large portion sizes~     differs between women who have received portion-control training and women who have not~     received such training. In a crossover design, women come to the laboratory on four~     occasions to eat a lunch of seven foods varying in energy density. Across meals, all foods~     are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy~     intake is determined for each meal. Participants are from two groups: women who completed a~     one-year weight-loss trial in which they were trained in portion-control strategies, and~     women who had not received such training (community controls).~   "
8758|NCT02942576|"~     There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with~     AF following catheter ablation. This phase 3b study is designed to evaluate the safety and~     to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based~     antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a~     central safety outcome in cardiovascular clinical trials, especially for antithrombotic~     strategies and invasive procedures.~   "
8719|NCT02943083|"~     The aims of this study are to determine if:~        1. during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving~          a pleasing scent (i.e. a relaxation ritual) can, acutely, reduce maternal stress and~          affect the fetus (in terms of movement, changes in heart rate and heart rate~          variability);~        2. a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent~          (i.e. a relaxation ritual) during pregnancy can have an effect on mitochondria~          functioning in the placenta through reducing maternal stress during pregnancy (based on~          our recent findings (Monk et al, 2016));~        3. the scent will come to function as a conditioned stimulus such that exposure to the~          scent postpartum will induce greater maternal relaxation, which will have an effect on~          the mother-infant interaction and infant physiology;~        4. prenatal maternal exposure to scent combined with abdominal touch will lead to mothers'~          increased likelihood of utilizing infant massage with a lotion of the same scent~          postpartum;~        5. the prenatal ritual and the increased likelihood of engaging in infant massage will~          lead to a maternal perception of greater mother-infant bonding, attachment and~          parenting efficacy, and improved maternal mood;~        6. the prenatal ritual and the increased likelihood of engaging in infant massage will~          lead to improved performance on the conjugate reinforcement paradigm conditioning task~          administered to infants at 4 months of age~   "
8720|NCT02943070|"~     Evaluate the safety and efficacy of the Rezum System for the treatment of BPH~   "
8721|NCT02943057|"~     25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either~     uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for~     6 weeks.~      Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be~     reviewed at the clinic within 3 hours following the last application of topical ganciclovir~     and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is~     drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for~     ganciclovir drug level by HPLC method.~   "
8722|NCT02943044|"~     The goal of this study is to determine the optical spectroscopy characteristics of tumor in~     patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of~     all head and neck cancers. These spectroscopy measurements will be compared with~     pathological diagnosis of tissue biopsies from the same site. These readings will be~     performed in the operating room during routine endoscopy with biopsy and tumor mapping of~     patients who have a suspected squamous cell carcinoma of the head and/or neck. Furthermore,~     a built in pressure sensor will be used to compare biopsy sites with their benign~     counterparts. If successful, the optical measurements could be used to survey for and~     delineate the extent of malignancies in a noninvasive manner. This would be especially~     helpful for clinic visits where suspicious lesions are seen and would otherwise require~     biopsy for diagnosis. Immediate benefits would include patients with unknown primaries in~     which numerous directed biopsies are obtained from multiple head and neck sites.~   "
8723|NCT02943031|"~     This is a prospective cohort study. Patients who meet the inclusion criteria will be~     enrolled in this study. The samples of biliary tract tumors will be collected. Genome~     sequencing, mini-PDX and PDX will be performed according to the requirement of~     individualized precision therapy programs. Suitable drugs will be chose according to drug~     screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the~     effect of individualized precision therapy programs.~   "
8724|NCT02943018|"~     Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound~   "
8725|NCT02943005|"~     The aim of this study is to compare rehabilitation with the wearing of a sling, to~     rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus~     tendon. The goal is to offer to patients a simplified rehabilitation management, with a~     faster recovery, less pain and a quicker return to normal life.~   "
8726|NCT02942992|"~     To develop an intervention specifically targeted for these clients who have the frailty~     syndrome. The Investigators propose to develop an exercise intervention that can reduce~     frailty in older adults to facilitate their ability to age-in-place. The long-term objective~     of this work is to develop a package of interventions that can be administered within the~     existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific~     goal of this proposal is to develop a resistance exercise intervention to reduce frailty in~     older adults receiving long term care services in their home through the Illinois Community~     Care Program, a HCBS Waiver Program.~   "
8727|NCT02942979|"~     This study seeks to implement wrap around services for Veterans suffering from co-occurring~     mental illness and substance use and who are homeless. It will compare Implementation as~     Usual of MISSION to Facilitation Implementation of MISSION.~   "
8728|NCT02942966|"~     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate~     the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial,~     and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post~     percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.~   "
8729|NCT02942953|"~     The diaphragmatic pacemaker (DP) has proven its utility in replacing mechanical ventilation~     (MV) in patients with chronic spinal cord injury (SCI) and Amyotrophic Lateral Sclerosis~     (ALS), by improving the patients quality of life and reducing morbi-mortality and the~     associated health care costs. The anesthetic management of these patients and the~     particularities of the surgical procedure represent an anesthetic challenge. The objective~     of our study is to analyze the management and the intraoperative complications in the~     patients with DP in our institution.~   "
8730|NCT02942940|"~     Background: Telemedicine is increasingly used to overcome distance between patients and~     physicians. Preliminary studies suggest that mobile app follow-up care for ACL~     reconstruction patients is feasible, can avert in-person follow-up care, and is~     cost-effective.~      Objective: To avert in-person follow-up through the use of a mobile app in the first six~     weeks after surgery.~      Methods: This will be a single-center, prospective randomized controlled trial~      Results: Data to be analyzed from 72 patients.~   "
8760|NCT02942550|"~     This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on~     the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial~     infarction (STEMI). Half of the participants will receive methylnaltrexone, while the other~     half will receive placebo.~   "
8731|NCT02942927|"~     In an aging population, most seniors suffer from multiple chronic conditions. When the~     number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent~     medications can do more harm than good. Seniors take an average of 7 regular medications and~     studies link polypharmacy with adverse effects on morbidity, function and health service~     use. However, it is not clear to what extent these are reversible if medication burden is~     reduced.~      This trial will test the effects on medication numbers and patient health outcomes of an~     intervention to polypharmacy. This study will test a program focused on medication reduction~     number and dose. Prioritizing medications according to the patient's preference as reducing~     the dose also reduces the risk of drug side effects.~      Patients, aged over 69 years taking ≥5 medications, will randomly receive the program~     immediately or at 6 months. The program involves information gathering from the patient,~     including systematically seeking patients priorities and preferences medication review with~     the pharmacist and then a consultation with the family doctor. The intervention is focused~     on discontinuing/reducing the dose of medications where possible using a 'pause and monitor'~     framework to assess the need for restart. An electronic program that detects drug adverse~     effects and flags potentially inappropriate medications will be integrated into an~     electronic clinical pathway incorporating monitoring and follow up systems.~      This study will examine effects on patient and health relevant outcome measures as well as~     qualitative research exploring patients' and clinicians' experiences of reducing medication~     burden. The results will be used to determine whether this system can be implemented as part~     of routine preventative care in primary care for older adults.~   "
8732|NCT02942914|"~     This trial is conducted to evaluate the safety of a study drug given by injection under the~     skin to healthy participants and participants with type 2 diabetes. It will also investigate~     how the body processes the study drug and the effect of the study drug on blood sugar~     levels. Information about any side effects and tolerability will be documented. This study~     is approximately 30 days for each participant, not including screening. Screening is~     required within 28 days prior to the start of the study.~   "
8733|NCT02942901|"~     Surgery has been available for the treatment of pulmonary metastases in metastatic~     colorectal cancer and promising overall survival was observed in retrospective studies with~     selected patients. This study investigated whether the preoperative FDG- PET/CT scan~     influences survival in this patient group. Furthermore, we tried to identify other~     prognostic factors associated with overall survival and progression-free survival.~   "
8734|NCT02942888|"~     The purpose of this study is to determine the effects of Niagen (nicotinamide riboside,~     vitamin B3), on NAD levels, brain function including cognition and blood flow in people~     diagnosed with mild cognitive impairment (MCI).~   "
8735|NCT02942875|"~     Our study aims at investigating the effect of intensive mirror therapy on the motor recovery~     of severely impaired paretic arm at subacute stroke.~   "
8736|NCT02942862|"~     Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the~     pathological results. Histoprognostic new factors have recently been published by several~     authors, but their validity is still debated.~   "
8737|NCT02942849|"~     Prospective, non-comparative, multi-centre, multi-country, observational post-authorization~     study, to correlate predictive factors with number of oocytes in relation to the~     gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation~     and GnRH-antagonists for pituitary suppression~   "
8738|NCT02942836|"~     The goal of the proposed study is to test the capability of the CareTaker monitor to extract~     the respiration signature from its acquired signal, and to determine a respiration rate of~     breaths/minute that meets or exceeds the performance levels of its predicate device.~   "
8739|NCT02942823|"~     Obesity and its associated comorbidities are becoming a key and rapidly growing public~     health problem. The cause of obesity is an imbalance between energy intake and energy~     expenditure in favor of the former. Childhood and adolescence are seen as critical time for~     its development. It is therefore crucial to provide both prevention and treatment actions~     already during childhood. The prevention and treatment weight-management programs in~     children focus on improving diet, eating behaviours, psychosocial aspects and increasing~     physical activity. One important basic requirement for any weight-management program is,~     that both children and their families are motivated and ready for change. Video games,~     including exergames, serious games or combined approaches offer additional chances in the~     treatment and prevention of obesity by approaching children in their environment and~     motivating them to deal with life-style topics.~      As children do not decide alone what they eat - but their parents - the involvement of~     parents in the intervention appears to be very important to reach a sustained effect.~      The investigators developed a motion-controlled serious game for children aged between 9 and~     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial~     factors. In addition to the motion control, a tablet is used for knowledge-based and~     cognitive tasks. In comparison to other studies the nutrition part not only deals with the~     food pyramid but also with the energy density of foods and liquids and offers a~     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological~     aspects, especially stress and stress-coping strategies are addressed e.g. by~     relaxation-exercises and a reflexion exercise about leisure behaviour. The game consists of~     two sessions, having each a duration of about 35 minutes.~      The aim of the KOP-1 study was to evaluate the game regarding its acceptance and efficacy in~     a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12~     years. The aim of the here presented KOP-2 study is to evaluate the game regarding its~     acceptance and efficacy in a randomized controlled trial in parents of primary school~     children aged 9 to 12 years receiving the KOP-1 intervention. Therefore, 4th grade pupils of~     the same school will be randomly allocated to an intervention and a control group. Both~     groups will play the game within two weeks, whereas the intervention group will take the~     game home on a tablet computer to play it with their parents in between session 1 and 2. At~     baseline, one day after session 2 and at four weeks follow-up, measurements will be~     performed in pupils and the parents of the intervention group. The primary outcomes of the~     study are the gain of knowledge (nutrition, psychosocial aspects) in parents and children,~     measured by a self-constructed questionnaires tailored specifically for the serious game.~     Secondary outcomes are the interaction of pupils and their parents for the intervention~     group, acceptance of the game, changes of nutrition behaviour, physical activity and~     intentions of the children to follow a healthy lifestyle, measured by mostly validated~     questionnaires.~   "
8740|NCT02942810|"~     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male~     and female subjects with normal and impaired renal function. The study will be composed of~     five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients)~     renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their~     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).~     The severity of renal impairment will be assessed based on estimated creatinine clearance~     (CLCR) by the Cockcroft-Gault equation~   "
8741|NCT02942797|"~     This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease~     (COPD) with respiratory failure and admitted in West China Hospital during November 2016 to~     October 2018. The following variables will be prospectively studied: age, sex, height,~     weight, respiratory function indicators, arterial blood gas analysis results, biochemical~     data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic~     outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis~     predictor in COPD patients with respiratory failure.~   "
8742|NCT02942784|"~     This is a retrospective study of patients diagnosed with chronic obstructive pulmonary~     disease (COPD) with respiratory failure and admitted in West China Hospital during January~     2014 to October 2015 by review of medical records. The following variables will be~     retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2,~     nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic~     outcomes, and so on. The purpose of this study is to compare the predictive power of three~     widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic~     outcomes in a cohort of COPD patients with respiratory failure.~   "
8743|NCT02942771|"~     The purpose of this Study is to find out whether an investigational drug is safe and well~     tolerated. MW189 is being studied as a possible short-term treatment for people with~     different types of brain injury. MW189 has previously been given to healthy human volunteers~     as a single dose, and there were no significant problems or bad effects in people who~     received the Study drug. However, before it can be tested in people with brain injury, it is~     important to test MW189 in healthy volunteers when given multiple doses.~   "
8773|NCT02942381|"~     The investigators study will recruit IgA nephropathy patients with proteinuria range from~     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were~     treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded~     every two months and total four months. Then, the drug will be stopped for two months for~     observation of change of proteinuria.~   "
8745|NCT02942745|"~     Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive~     substance in the world, following only alcohol, nicotine, and caffeine in prevalence of~     consumption. Although betel nut is chewed by approximately 600 million people globally, its~     use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has~     been classified as a Group 1 carcinogen by the International Agency for Research on Cancer.~     Despite the global significance and carcinogenicity of betel nut, there has been very little~     behavioral or psychological research about betel nut chewing, and there has been no~     systematic research on the topic of betel nut cessation interventions. The current~     intervention builds directly upon the National Institutes of Health - National Cancer~     Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive~     Partnership to Advance Health Equity. Previous data collected through the partnership~     suggest that betel nut chewers, like smokers, generally want and intend to quit, but do not~     have specific plans of how or when they will quit. In addition, most betel nut chewers in~     the partnership's previous study already have tried to quit on one or more occasions. The~     findings suggest that betel nut chewers could benefit from cessation programs modeled after~     smoking cessation programs. During 2014, partnership investigators conducted a feasibility~     study of the betel nut cessation program. The program was well received and yielded~     surprisingly high rates of self-reported betel nut cessation.~      Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation~     program.~      Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut~     cessation intervention trial using bio-verification.~   "
8746|NCT02942732|"~     The investigators examined the effect of vitamin D supplementation on glucose homeostasis~     and metabolic markers in healthy normal weight and overweight young subjects and healthy~     normal-weight and overweight elderly subjects living in Beirut, Lebanon.~   "
8747|NCT02942719|"~     1. To describe the average labor curve and establish new labor progression standards.~        2. Cesarean section rates: Based on big data, the investigator will introduce the~          international advanced Robson class method and identify the appropriate level of~          cesarean section rate for each type population.~        3. Establishment of Chinese maternal-fetal medical collaboration network and APP to~          promote natural childbirth.~   "
8748|NCT02942706|"~     This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment,~     versus continuation after 8 courses of induction therapy with cetuximab plus standard~     chemotherapy regimen (FOLFIRI or mFOLFOX6）in metastatic colorectal cancer (mCRC) patients.~     The maintenance treatments are continued until disease progression or untolerated toxicity.~     The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to~     continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or~     CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.~   "
8749|NCT02942693|"~     It is a randomized phase II study to determine the efficacy and safety of particle therapy~     with or without apatinib as induction therapy for the treatment of head and neck adenoid~     cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly~     followed by particle radiotherapy; arm 2: particle radiotherapy alone.~   "
8750|NCT02942680|"~     evaluate the safety of preoperative aspirin therapy when performing bypass surgery in~     conditions of artificial blood circulation~   "
8751|NCT02942667|"~     The primary objective is to collect high quality MRI data (un-processed or processed) from~     participating subjects for Medtronic research purposes.~   "
8752|NCT02942654|"~     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect~     of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be~     documented. The study will last about 6 to 7 weeks for each participant, including screening~     and follow up. Screening is required within 28 days prior to entering the study.~   "
8753|NCT02942641|"~     Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients.~     Either indwelling urethral catheterization or clean intermittent catheterization (CIC) can~     be the choice of treatment. In chronic urinary retention, most physicians prefer CIC to~     chronic indwelling urethral catheter on the basis of the claim that the rate of~     catheter-associated urinary tract infection (CAUTI) is lower.~      Method: The patients were randomized into indwelling urethral catheter and CIC groups. The~     primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI.~     The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.~   "
8754|NCT02942628|"~     Open label, 6 week randomized, cross-over study to compare the effect of a vegetarian diet~     to a conventional (meat containing) diet based on the Swedish average meat consumption on a~     range of parameters with prognostic importance for cardiovascular disease.The study will be~     conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients~     will benefit from a vegetarian diet as assessed by multiple risk markers for this type of~     disease with a primary focus on changes in oxidized LDL cholesterol.~   "
8755|NCT02942615|"~     Under the modern precise radiotherapy technology, clear the best dose volume limit index and~     the limit value for the primary level prevention of heart injury; clear best follow-up~     interval and measures for heart function of breast cancer patients, to achieve the secondary~     prevention of cardiac injury; explore combined cardiovascular specialist optimal treatment~     strategy for heart injury in the treatment of breast cancer, during the tertiary prevention~     of cardiac injury; put forward rationalization proposal for prevention, treatment and~     follow-up for breast cancer associated with heart injury.~   "
8756|NCT02942602|"~     1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate~     if this test correlates with cardiovascular risk, independent of traditional risk factors;~     3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL~     function and composition~   "
8926|NCT02940379|"~     Primary Objective:~      To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A~     activities using a CYP probe cocktail of metoprolol and midazolam.~      Secondary Objective:~      To assess the clinical and laboratory safety of sotagliflozin coadministered with the~     cocktail probes as compared to that of cocktail probes alone.~   "
8927|NCT02940366|"~     This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose~     control in patients with metabolic syndrome.~   "
8761|NCT02942537|"~     Uterine fibroids are benign tumors that occur most commonly in women of reproductive age.~     Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia,~     pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention~     has been paid to the study of minimally invasive methods for treatment. Microwave ablation~     of myomas and endometrium has been shown to have good effect and acceptability has been~     high. This study aims to compare the effectiveness, feasibility and acceptability of~     percutaneous Cmicrowave ablation and uterine artery embolization for the treatment of~     uterine myomas in a randomized single blind study.~      Primary outcome~      1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured~     as mean volume reduction of the 3 largest fibroids evaluated by magnetic~      Power calculation~      To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in~     microwave ablation and 50%[11] in the embolization group with a standard deviation of 25%~     with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need~     to randomize 32 women.~      In order to compensate for loss to follow-up or drop out a total of 36 women will be~     randomized.~      Patients and investigators will not be blinded. The MRI will be performed and evaluated by a~     blinded radiologist.~      After having signed informed consent but before randomization patients will undergo MRI of~     the uterine fibroids. Patients with a single fibroid measuring more than 6cm will be~     excluded from further participation in the study.~      All women included in the study after MRI examination will fill in a PBAC evaluation[7]~     during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month~     prior to treatment.~      Microwave ablation will be performed percutaneously using a Covidien Emprint microwave~     ablation system. Embolization will be performed in conscious women with an epidural catheter~     for pain relief.~      At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as~     overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the~     treatment to a friend.~      A new MRI scan will be performed 6 months post treatment (+/-15 days).~   "
8762|NCT02942524|"~     This clinical trial studies how well a checklist tool works in engaging patients in the~     discharge planning process. Engaging patients in the discharge process may increase~     participation in the discharge process and improve discharge outcomes, understanding of care~     after hospitalization, and decrease complications.~   "
8763|NCT02942511|"~     To idetify the factors favoring the use of enteral nutrition would be helpful to select~     preferred patients suitable for enteral nutrition.~   "
8764|NCT02942498|"~     The purpose of this study is to determine vitamin C and vitamin E in combination are~     effective in the treatment of cognitive and behavior disorder in children with fragile X~     syndrome.~   "
8765|NCT02942485|"~     This study investigates the efficacy and safety of rectally administered metronidazole for~     pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by~     patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior~     to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be~     tolerated as good as tinidazole.~   "
8766|NCT02942472|"~     Position of the tip of the inner catheter and air bubbles detection (at time,5min~     10min)during embryo transfer influence the pregnancy rate in ICSI cycles .~   "
8767|NCT02942459|"~     The Aim of this National study is to examine whether music therapy can reduce negative~     symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an~     Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are~     anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music~     Therapists and time compensated Music Listening by unknown Care Staff Members.~      The Study is a close Cooperation between Aalborg University (The Music Therapy Research~     Clinic) and Aalborg University Hospital,Psychiatry (The Center of Schizophrenia Research).~   "
8768|NCT02942446|"~     This investigation is designed to evaluate the at-home usability, performance, user~     acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.~   "
8769|NCT02942433|"~     Introduction: Change Starts at Home (Change) is a multi-component social behavior change~     communication and community engagement strategy designed to prevent intimate partner~     violence (IPV), a significant public health issue in Nepal and throughout the world.~      Methods and analysis: The study uses a concurrent mixed-methods design. The quantitative~     aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded~     cluster trial (RCT: N=36 clusters, 1440 individuals), comparing a social behavior change~     communication (SBCC) strategy to radio programming alone for its impact on physical and / or~     sexual IPV at the end of programming (12 months' post-baseline) and 6-months post the~     cessation of project activities (18-months post baseline). The qualitative aspects of the~     design include several longitudinal approaches to understand the impact of the intervention~     and examine mechanisms of change including in-depth interviews with participants (N=18~     couples), and focus group discussions with community leaders (N=3 groups), and family~     members of participants (N=12 groups). Treatment effects will be estimated with generalized~     logistic mixed models specified to compare differences in primary outcome from baseline to~     follow-up, and baseline to 18-months post following intention-to-treat principles.~   "
8770|NCT02942420|"~     Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus~     prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction)~     who are failing therapy will be selected for this trial.~      After completing informed consent, the subject will have Screening consisting of medication~     history and physical examination with vital signs. Samples of blood and urine will be taken~     for clinical laboratory and urinalysis. Patients will undergo a 12-lead ECG test. A history~     of side effects with current CBTD as well as laboratory recordings of abnormalities~     attributable to treatment will also be recorded.~      Subjects will be dosed in a sequential manner, starting with the low dose group (300~     mg/day), then proceeding to the 600 mg.day dose group.. Safety and tolerability will be~     monitored closely by an Independent Medical Monitor (IMM) and based on the IMM's assessment~     that it is safe to proceed to the higher dose (600 mg/day), subsequent subjects will be~     enrolled into that group. Up to 15 subjects each will be enrolled into either Group A or~     Group B.~      After 7 days on the assigned bucillamine dose, a 24-hour urine sample will be taken and~     after completing the Day 8 safety visit, subjects will undergo a 7 day washout where no~     CBTDs will be taken. Thereafter, subjects will be allowed to resume their originally~     prescribed CBTDs under Investigator's supervision.~      One week following study drug discontinuation, subjects will return to the clinic for~     follow-up safety assessments.~   "
8771|NCT02942407|"~     This is a prospective, randomized, open-label, blinded end-point evaluation trial. The~     patient population consists of patients on hemodialysis who have atrial fibrillation (AF)~     and end-stage renal disease (ESRD) .~   "
8772|NCT02942394|"~     Primary objective:~      To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the~     sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins)~     by evaluating different gradations of patency rates, patient's rating of disease severity~     and quality of life in patients with post-thrombotic syndrome and concomitant common iliac~     vein compression.~      Secondary objective:~      To assess long-term safety of venous stenting~   "
8774|NCT02942368|"~     This pilot study aims to investigate the potential role of transcranial direct current~     stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD).~     tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment~     of major depression in several studies, both as a primary and adjunctive treatment. The~     treatment will be administered under the supervision of a physician with experience in~     administering the treatment and monitoring for complications. This will be a prospective~     adaptive tDCS stimulation open label research study. Participants will receive 20 minute~     sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to~     6 weeks. Building on the theory that greater current dose may be a significant factor in~     determining efficacy, this study aims to determine whether higher tDCS current doses lead to~     greater improvements in depressive symptoms in this population of patients with~     treatment-resistant major depressive disorder.~   "
8775|NCT02942355|"~     This is an open-label, pilot study designed to evaluate the safety and feasibility of~     combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line~     therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal~     patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal~     women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an~     approved LHRH agonist administered according to its respective prescribing information.~     Following informed consent and eligibility check, subjects will be enrolled to either Cohort~     A or Cohort B.~   "
8776|NCT02942342|"~     The primary goal of this study is to determine the prevalence of undiagnosed asymptomatic~     coronary artery disease (CAD) in Kalamazoo and its neighboring areas using Coronary Computed~     Tomography (CCTA) and Coronary Artery Calcium Score (CACS) to assess if asymptomatic CAD is~     widespread enough to warrant implementation of CCTA as a routine screening tool.~     Additionally, this study will use the CCTA results to evaluate several methods of assessing~     CAD risk in the asymptomatic population including Framingham Risk Score (FRS) and Reynold's~     Risk Score, Biomarkers (High sensitivity C-Reactive Protein, Fibrinogen, Vertical Auto~     Profile, oxidized Low Density Lipoprotein (LDL), Apolipoprotein A1 (ApoA1), Apolipoprotein~     B1 (ApoB1), Vitamin D, Homocysteine) as well as a large panel of genetic markers of~     atherosclerosis and dyslipidemia.~   "
8777|NCT02942329|"~     The purpose of this study is to observe and preliminary explore the efficacy and safety of~     combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma~     or gastric cancer.~      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine~     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that~     of vatalanib or sorafenib.~      SHR-1210 is a humanized anti-PD-1 monoclonal antibody.~   "
8778|NCT02942316|"~     In this study, the pupillary dilation reflex is measured as a nociceptive indicator during~     elective abdominal surgery under general anesthesia.~   "
8779|NCT02942303|"~     The purpose of this study is to describe two safe and reproducible techniques for brow~     lifting using botulinum toxin. It will also describe the effect of both techniques on the~     eyebrow shape using quantitative, objective measurements and subjective scales. An~     additional systematic review of the literature will summarize all published trials for brow~     lifting using botulinum toxin.~   "
8780|NCT02942290|"~     This is a randomized, Phase 2, dose-ranging study to evaluate the safety, pharmacokinetics~     (PK), and efficacy of venetoclax administered in combination with azacitidine in~     participants with treatment-naïve higher-risk (HR) MDS as compared to azacitidine~     monotherapy.~   "
8781|NCT02942277|"~     Background:~      Researchers are looking for new ways to control and eradicate malaria. They want to test~     vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing~     antibodies in a person. The antibody is then taken up with blood by a mosquito that bites~     the person. This blocks parasite development in the mosquito. This stops malaria~     transmission to another person.~      Objective:~      To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of~     the vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults.~      Eligibility:~      Healthy Malians ages 18 50 living in certain areas in Mali who:~      Are not pregnant or breastfeeding~      Are not infected with HIV, Hepatitis B and Hepatitis C~      Do not have evidence of immunodeficiency~      Do not have history of severe allergic reaction or anaphylaxis~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Malaria Comprehension Exam~      Blood and urine tests~      Electrocardiogram (for participants in certain study groups)~      Participants will be randomly assigned to a study group.~      Participants will be monitored for 12 16 months. For the first 7 months, they will have~     between 1 and nine visits a month. The number depends on the month and on what group they~     are in. For the rest of the months, they will have 1 monthly visit.~      Each visit includes a physical exam. Most include blood tests.~      Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through~     an injection in the upper arm. This occurs at their first visit, then 1 month later, and~     then 5 months later.~      Participants will be followed for at least 6 months after the last vaccine.~      If participants develop an injection site rash or reaction, photographs may be taken of the~     site.~   "
8821|NCT02941744|"~     Nivolumab (OpdivoTM, BMS), a human IgG-4 anti-PD-1 monoclonal antibody has demonstrated~     anti-tumor activity in patients with advanced melanoma.~      The investigators postulate that patients with melanoma nivolumab have a comparable tumor~     response rate at a dose range of 0.1 to 10 mg/kg q2wks.~      Ipilimumab (YervoyTM, BMS), a human IgG-1 anti-CTLA-4 monoclonal antibody improves the~     survival of patients with advanced melanoma. Adjuvant therapy with ipilimumab improves the~     relapse-free survival after complete resection of high-risk stage III melanoma (EORTC~     18071).~      Combined treatment with ipilimumab plus nivolumab improves the tumor response rate and~     overall survival of patients with advanced melanoma but is associated with a higher~     incidence of immune related adverse events (CheckMate 067).Nivolumab and ipilimumab have~     distinct immunological mechanisms that can be revealed by analyzing TCR usage in blood~     lymphocytes.~   "
8822|NCT02941731|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1403 and HGP0919 suspensions in healthy male volunteers.~   "
9371|NCT02934568|"~     This study is to allow continued use of ribociclib (LEE011) as single agent or in~     combination with other investigational treatments in patients benefitting from treatment in~     an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary~     objective(s) or has been halted for other reasons.~   "
8782|NCT02942264|"~     Background:~      TG02 is an investigational drug that penetrates the blood-brain barrier and might treat~     brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors.~      Objective:~      To find out if TG02 is safe, and to find out if it in combination with TMZ is as effective~     as TMZ alone in people with brain tumors.~      Eligibility:~      People ages 18 and older with a brain tumor that has progressed after standard treatment~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      MRI of the brain if they have not had one in 14 days~      Heart test~      Tissue sample from prior surgeries~      Participants will take TG02 plus TMZ by mouth in 28-day cycles.~      Some will take TMZ for 7 days on and 7 days off. Others will take it every day.~      They will all take TG02 three days before Cycle 1, and then on four days during every cycle.~      They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after~     each TG02 dose.~      They will all keep a diary of when they take the drugs and their symptoms.~      Participants will have study visits. These include:~      Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4~     weeks~      Blood tests every 2 weeks~      Participants will continue treatment until their disease gets worse or they have intolerable~     side effects.~      Participants will also be enrolled in another protocol to test molecular markers for their~     brain tumor....~   "
8783|NCT02942251|"~     Major depressive depression(MDD) is an severe public mental disorders. The purpose of~     current study is using big data analysis based on clinical features and immunochemistry to~     investigate and establish an relapse predict model for patients with first episode MDD.~   "
8784|NCT02942238|"~     To standardize the surgery for advanced right hemi colon cancer with laparoscopy and~     investigate whether extended lymphadenectomy (CME) could improve disease-free survival in~     patients with right colon cancer, compared with D3 radical operation in laparoscopic~     colectomy.~   "
8785|NCT02942225|"~     The purpose of this study is to understand the pathophysiological mechanisms of ADHD,~     especially the metabolomic pathway related to the behavioral/neuropsychological deficits of~     ADHD.~      To identify specific metabolites that show significant differences between ADHD and control~     groups, both liquid chromatography-mass spectrometry and gas chromatography-mass~     spectrometry will be performed. In addition, the behavioral measures include ADHDRS-IV,~     SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including~     CPT and CANTAB, will be performed. Conditional logistic regression and partial least squares~     discriminant analysis will be applied to identify significant metabolites for ADHD. Pathway~     enrichment and topology analyses will be conducted to evaluate the regulated pathways.~   "
8786|NCT02942212|"~     In-Depth Interviews:~      The goal of this research study is to learn about ways to help people might have trouble~     understanding health information quit smoking.~      Pilot Study:~      The goal of this research study is to test 2 different approaches, Standard Treatment (ST)~     and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping~     smokers who might have trouble understanding health information with quitting smoking.~   "
8787|NCT02942199|"~     The goal of the MyMOBILE study is to evaluate the feasibility, acceptability, and usability~     of a novel platform that integrates text messaging reminders, secure electronic pill~     organizers, and daily remote brief motivational recovery support visits with a standardized~     protocol for supervised self-administration of buprenorphine via videoconferencing.~   "
8788|NCT02942173|"~     The purpose of this prospective randomized study is to determine whether infusions of~     T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta~     T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).~   "
8789|NCT02942160|"~     A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic~     Panniculopathy (commonly known as Cellulite).~   "
8790|NCT02942147|"~     Objective: The objective of this study is to compare the efficacy of TENS (transcutaneous~     electrical nerve stimulation) therapy with those of the conventional radiofrequency and~     pulse radiofrequency therapies.~      Design: A single-blind randomized controlled trial~      Setting: An outpatient physical therapy and rehabilitation clinic~      Subjects: The study included 60 patients who presented with a complaint of chronic low back~     pain prevailing at least for 3 months and who were diagnosed with facet joint syndrome.~      Interventions: The patients were randomized into 3 groups so that Group 1 (n: 20) patients~     would receive conventional radiofrequency therapy, Group 2 (n: 20) patients conventional~     TENS procedure for 15 days and Group 3 (n: 20) patients pulse radiofrequency therapy.~      Main measures: The patients were assessed before treatment, and at month 1 and 6 for pain~     (visual analogue scale), disability (Oswestry Disability Index), lumbar movements~     (hand-floor distance), functional status (20-meter walking times, 6-min walking distances),~     quality of life (Short Form 36), and depression (Beck Depression Inventory).~   "
8791|NCT02942134|"~     Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients~     with COPD and emphysema. This trial aims to document incidence and severity of augmented~     dyspnea in patients with long term NIV therapy. These findings may help in understanding the~     pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy~     schemes.~   "
8792|NCT02942121|"~     The purpose of this study is to learn whether it is feasible to use the LifeScience~     Technologies application (LST app) in patients undergoing radical cystectomy with the~     eventual goal to reduce complications and readmissions to the hospital after surgery.~   "
8793|NCT02942108|"~     The aim of this clinical trial is to investigate and compare the effect of piezoelectric~     surgery on tissue, cellular and molecular level of oral surgical wound healing and~     postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy~     patients~   "
8794|NCT02942095|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ixazomib and erlotinib that can be given to patients with advanced solid~     tumors. The safety of these drugs will also be studied.~   "
8795|NCT02942082|"~     Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.~   "
8796|NCT02942069|"~     The purpose of this project is to investigate whether the glucose response in type 1~     diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible~     in repeated standardized test sessions that include physical activity.~   "
9372|NCT02934555|"~     To study the effects of ubiquinol as a metabolic resuscitator in post-cardiac arrest.~   "
8797|NCT02942056|"~     The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment~     of T2DM. Additional aims will assess the effect of cinnamon on cardiovascular risk factors~     and explore novel potential mechanisms of action leading to improved insulin sensitivity.~     Based on previously published animal and human data we have hypothesized that six months~     treatment with Cinnamon cassia supplementation (2.25 grams/day) will improve glycemic~     control and cardio-metabolic risk factors. We believe these benefits may be mediated in part~     through improved insulin mediated capillary recruitment and skeletal muscle vasodilators~     leading to reduced insulin resistance. We will achieve our goal through completion of the~     following aims:~      Aim 1. To demonstrate the efficacy, safety, and tolerability of oral cinnamon use (750 mg~     three times daily) to improve glucose control. The primary outcome will be determined as a~     reduction in hemglobin A1c (HbA1c) level of at least 0.5% compared to placebo.~      Aim 2. To quantify effects of oral cinnamon (vs. placebo) on cardio-metabolic risk factors,~     including: fasting levels of plasma insulin and glucose, homeostatic model assessment of~     insulin resistance (HOMA-IR), lipids (total, VLDL, LDL, HDL cholesterol; triglyceride), free~     fatty acids, as well whole body, abdominal, and visceral adiposity as measured with dual~     energy x-ray absorptiometry (DEXA) imaging.~      Aim 3. In this mechanistic exploratory aim, potential gastrointesitnal effects will be~     assessed as follows: a 3-hour oral glucose tolerance test (OGTT) with blood samples~     collected for insulin, glucose, C-peptide, glucagon, GLP-1, and GIP will be performed~     separately. Additional biochemical markers (ghrelin, PYY, pro-insulin, apo B, adinopectin)~     will be collected as well.~   "
8798|NCT02942043|"~     The purpose of this study is to explore the efficacy and safety of different doses of~     bevacizumab injection in the treatment of malignant pleural effusion in patients with~     advanced non-squamous non-small cell lung cancer.~   "
8799|NCT02942030|"~     Attentional symptoms characterize both ADHD and other mental conditions in children.~      The diagnosis is based on clinical psychiatric evaluation.~      With the expanding knowledge regarding the neurobiological basis in ADHD the investigators~     have learned that attention is not a general property of the whole brain, but involves~     several coordinated networks. This knowledge promoted the scientific community to the stage~     in which scientists can recognize different types of attention domains.~      in the current study, the investigators use computerized battery to separate between the~     different attention abilities and provide specific attentional profile. in this study the~     investigators aim to characterize different attentional profiles in children who are~     diagnosed with ADHD versus children who diagnosed with other mental condition (which are~     common differential diagnoses of ADHD)~   "
8800|NCT02942017|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 36 adult female~     subjects diagnosed with moderate postpartum depression~   "
8801|NCT02942004|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to~     60 adult female subjects diagnosed with severe postpartum depression~   "
8802|NCT02941991|"~     The purpose of this study is to evaluate the safety and tolerability of hESC-RPE cellular~     therapy in patients with advanced SMD over a five-year period following the surgical~     procedure to implant the cells.~   "
8803|NCT02941978|"~     The purpose of the study is to investigate the impact of motivational interviewing in the~     adherence of patients with AF to oral anticoagulation (OAC) regimens. Half of the patients~     will be interviewed and guide on the importance of adherence to OAC medication. Patients~     assigned to the intervention group will be contacted at 1 week, 2 months, 6 months and 1~     year after discharge. Patients in the control group will be contacted at 1 year after~     discharge.~   "
8804|NCT02941965|"~     This will be a prospective, randomized (1:1 ratio) clinical trial for patients with~     male-factor infertility with or without preimplantation genetic screening (PGS). Qualified~     650 patients are randomized into either of two groups: group A will undergo intracytoplasmic~     sperm injection (ICSI) without PGS (325 cases), Group B will undergo ICSI with PGS (690~     cases). The partners of all participants will receive the same protocol for ovarian~     stimulation and standardized luteal phase support.~      The target population will be patients with male-factor infertility aged between 20 and 50~     years, diagnosed by the ESHER Criteria (oligospermia and asthenspermia). Women with other~     reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are~     excluded.~      The randomization will take place before the oocyte pick-up day by a computer randomization~     system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal~     complications will be followed up by checking medical records and telephone calls.~   "
8805|NCT02941952|"~     In high-risk patients, it is now recommended to guide the intraoperative volume replacement~     via the stroke volume.~      Today, the most commonly used technique for estimating the stroke volume is the~     transpulmonary thermodilution and the arterial waveform analysis in the radial artery by~     PICCO®.~      This technique has the disadvantage of being invasive and increasing the time dedicated to~     anesthesia during the surgery.~      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has~     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac~     output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of~     blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac~     output or stroke volume are inconclusive and contradictory.~      The objective of this study is to compare the use of non-invasive monitoring of stroke~     volume by ClearSight® with the transpulmonary thermodilution and the arterial waveform~     analysis in radial artery by PICCO® in abdominal major surgery.~   "
8806|NCT02941939|"~     Hyperbaric oxygen has previously been tested as a possible means for pre-conditioning to~     enhance exercise performance. This study is designed to examine the effects of exercising in~     a hyperbaric chamber for improving fitness when combined with high-intensity training.~   "
8807|NCT02941926|"~     The purpose of this Phase IIIb study is to collect additional safety and efficacy data for~     the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2-~     advanced breast cancer.~   "
9373|NCT02934542|"~     The objective of this study is to evaluate the ability to reduce the number of OR personnel~     required while performing the following procedures: colon resections, anti-reflux/hiatal~     hernia surgery with the AutoLap system compared with the standard operation.~   "
8808|NCT02941913|"~     BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a ﬁxed~     dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are~     a few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese~     patients has not yet been investigated. The aim of this study is to evaluate if the use of~     bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose~     (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass~     index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective,~     randomized double-blind trial will be conducted at the National Cancer Institute (INCA -~     HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of~     age with an ASA physical status of one to three, with body mass index equal to or greater~     than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be~     randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients~     will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII).~     Patients will be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery.~     After discharge, all patients will be contacted by telephone at regular intervals to record~     the episodes of nausea and vomiting as well as analgesic and antiemetic requirements. The~     primary outcome measure will include the number of emetic episodes, the incidence of nausea,~     the need for rescue antiemetics and the analgesic requirement over 48h. The secondary~     outcome will be to evaluate the frequency of polymorphism of the 5-HT3 receptors and their~     correlation with the antiemetic effect and adverse effects.~   "
8809|NCT02941900|"~     The purpose of this study is to learn whether the patient might be interested in skin cancer~     genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result~     from this testing. Testing for skin cancer risk based on the MC1R gene is not currently used~     in clinical practice; it will be offered in this study for research purposes only.~   "
8810|NCT02941887|"~     This study aimed at correlating global behavior of Down's Syndrome patients to periodontal~     disease status.~   "
8811|NCT02941874|"~     The purpose of this study is on one hand to verify the measurement conformity of the IRAP~     dosage and on the other hand to obtain normal values of the blood IRAP concentration on~     healthy volunteers.~   "
8812|NCT02941861|"~     Objective:~        1. To study the factors that influence the 3- year recurrence of liver carcinoma after~          surgery~        2. To study the related factors affecting recurrence of liver carcinoma after surgery~   "
8813|NCT02941848|"~     The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after~     administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in~     the healthy adults.~   "
8814|NCT02941835|"~     The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast~     irradiation in female patients with low to intermediate risk breast cancer, who undergo~     breast conserving therapy, including a boost dose of irradiation.~      An additional goal of this study is to assess tumor response to radiotherapy, by imaging~     modalities (PET-CT and MRI) and pathology~   "
8815|NCT02941822|"~     This study will evaluate the safety, tolerability and pharmacodynamics of ambroxol in~     participants with Parkinson Disease. Participants will administer ambroxol at five dose~     levels and will undergo clinical assessments, lumbar punctures, venepuncture, biomarker~     blood analysis and cognitive assessment throughout the course of the study.~   "
8816|NCT02941809|"~     This study evaluates the addition of placebo to the normal treatment course of methadone in~     patients who are undergoing treatment for opioid use disorder. All participants will be~     enrolled in a methadone outpatient treatment program who have been prescribed a daily~     regimen of methadone. Half of the participants will be given a placebo pill (to be taken~     with the methadone), and the other half will be given standard treatment of care.~   "
8817|NCT02941796|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1105 and~     co-administration of HGP0918, HGP0816 in healthy male volunteers~   "
8818|NCT02941783|"~     The objective in this study is collecting post-marketing information on the safety and~     efficacy of Kovaltry under the routine clinical practice.~   "
8819|NCT02941770|"~     The prevalence of pediatric obesity makes this condition a worldwide public health concern.~     Physical Activity (PA) is recognized as having many health benefits, many of them related to~     obesity and its comorbidities. Despite of all the efforts, the majority of the overweight~     children/adolescents still present low levels of PA and high levels of sedentary behaviors.~     Thus, it seems that the greatest challenge is to influence behavior change in order to~     increase PA exposure in this population. PA consultation can be a cost-effective way of~     enhancing PA and improve weight status among overweight children.~      The main objective of this study is to analyze if the inclusion of a PA consultation in a~     multidisciplinary program for the management of adolescent overweight improves body mass~     index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months,~     compared to those attending only the Pediatric and the Dietetic consultations.~      This study is designed as a non-randomized, controlled clinical trial with six months~     duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥~     p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled.~     Those with (i) major pathologies (other than obesity or its related comorbidities), (ii)~     inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any~     kind of prescription (other than antihypertensives or metformine), or (vi) being involved in~     another weight loss program will be excluded. According to the sample size calculation, we~     expect to recruit 129 participants that will be allocated in three groups by consecutive~     sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii)~     intervention group I - standard care plus PA consultation; (iii) intervention group II - 2~     weekly exercise sessions additionally to the standard care and PA consultations..~   "
8820|NCT02941757|"~     The purpose of this study is to modify the food culture of the fire service by motivating~     firefighters and their families to incorporate Mediterranean diet principles at work and~     home through behavior change strategies that involve education, participation and~     incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by~     successfully getting more firefighters and their families to adopt and incorporate the~     healthy eating principles behind the Mediterranean diet.~   "
8823|NCT02941718|"~     Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days~     and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important~     nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and~     predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers~     who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This~     study will address this conceptual and empirical gap by conducting a 12-week~     proof-of-concept study to determine whether standard smoking cessation treatment can be~     optimized with a multi-metric sleep advancement counseling intervention.~   "
8824|NCT02941705|"~     Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to~     determine whether treatment of HFPEF patients with intracoronary allogeneic CDCs affects~     clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics~     (supine exercise ergometry during right heart catheterization), myocardial interstitial~     fibrosis (MRI with native T1 mapping and calculation of extracellular volume [ECV] after~     gadolinium administration), macroscopic fibrosis by delayed gadolinium enhancement (DGE),~     and diastolic function (catheterization, echocardiography, BNP).~      Treatment of patients with symptomatic hypertensive heart disease-induced HFPEF with~     allogeneic CDCs will be safe and will improve clinical functional status, exercise~     tolerance/hemodynamics, myocardial interstitial structure, and diastolic function; the~     mechanisms underlying these improvements will be reflected in changes in plasma biomarkers~     that indicate a reduction in pro-inflammatory and pro-fibrotic signaling.~   "
8825|NCT02941692|"~     Oxytocin is a promising new medication found to have positive effects on prosocial behavior,~     reduce negative affect such as fear and anxiety, and reduce stress-induced addictive~     behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal~     oxytocin improves couples' conflict resolution skills and subjective, physiological, and~     neuroendocrine responses to conflict. Conflict resolution discussions will take place in the~     laboratory and will be videotaped.~   "
8826|NCT02941679|"~     A phase 3 study to evaluate efficacy and safety of HCP1202~   "
8827|NCT02941666|"~     Previous studies have shown an increase in the concentration of mesenchymal stem cells~     (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity.~     Researchers have shown that as there is an increase in the severity of the disease, the~     concentration of stem cells also increases. The purpose of this study is to determine if~     there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of~     the femoral head.~   "
8828|NCT02941653|"~     Objectives: This study will determine the effectiveness of the use of desensitivity gels~     prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office~     bleaching using 35% hydrogen peroxide. Materials and Methods: Fourty seven patients will be~     selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial.~     10 minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2%~     and potassium oxalate 5% desensitivity gel application on vestibular surface. The whitening~     treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day~     interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure~     using analog visual and verbal scales. Color alteration will be assessed by a bleach guide~     scale and Vita Easy shade spectrophotometer 7 days after each session. Relative risk to~     sensitivity will be calculated and adjusted by session; while comparison of overall risk~     will performed by McNemar's test. Data on the sensitivity level for both scales and color~     shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α =~     0.05).~   "
8829|NCT02941640|"~     During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop~     ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative~     technique with which laparoscopic appendectomy was done faster and cheaper than the standard~     techniques. However, biocompatibility of different materials udes in securing the base of~     appendix is different. It was observed that stapler's clips made by titanium caused the~     mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are~     their high price.~      Titanium clips made for the use in laparoscopic appendectomy are safe and effective option~     in securing the appendicular stump in laparoscopic appendectomy. They have potential~     advantages over stapler, because they have the same bio compatibility, and their price is~     lower.~   "
8830|NCT02941627|"~     The aim of the study is to assess the efficacy and the safety profile of the Neuro Cochlear~     Implant System (CIS) in adults with severe to profound sensorineural hearing disabilities.~   "
8831|NCT02941614|"~     Many breast cancer patients experience psychological distress during their cancer care~     journey. There are effective treatments for breast cancer patients experiencing distress,~     such as individual or group therapy, health education, and medication. Unfortunately,~     clinicians may not be aware of the symptoms of distress in their breast cancer patients, and~     some breast cancer patients who could benefit from referral to behavioral health specialists~     are overlooked. New guidelines recommend that all cancer patients be regularly screened for~     distress. However, there are unanswered questions about the impact of distress screening~     conducted on such a large scale. Few studies have evaluated the impact of distress screening~     on important outcomes in breast cancer patients, such as patient experience, symptom~     management, and use of health care services, as compared to the usual care offered by the~     health care organization. In addition, oncology clinicians are uncertain about the benefits~     of large-scale distress screening, and pilot screening programs have not been uniformly~     successful, particularly in the community oncology setting.~      The overarching goals of this study are to assess the effectiveness of implementing a~     guideline-recommended distress screening program for newly diagnosed breast cancer patients~     on improving identification and referral to treatment for highly distressed breast cancer~     patients, to assess patient-reported outcomes, health services utilization, and~     implementation outcomes of the program. This study will address two main research questions:~     1) Is a community-oncology based, large-scale distress screening program more effective than~     usual care on improved identification of distressed patients, referral to behavioral health~     services, and patient-reported outcomes for breast cancer patients? 2) What are the~     barriers, facilitators, and other implementation-related outcomes related to distress~     screening in the community oncology setting?~   "
8832|NCT02941601|"~     The main purpose of this study is to evaluate the effectiveness and safety of~     gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally~     advanced or metastatic squamous non-small cell lung cancer.~   "
8833|NCT02941588|"~     Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should~     optimally be delayed one year after percutaneous coronary intervention (PCI) with~     drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or~     at least aspirin is recommended to be continued considering the relative risk of bleeding~     and stent thrombosis especially during the first 4 to 6 weeks after DES implantation.~     However, these recommendations are based upon insufficient and conflicting evidences.~   "
8834|NCT02941575|"~     In patients receiving implants in the esthetic zone, would the use of new Nano hybrid~     ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and~     peri-implant tissue success when compared with Lithium Disilicate crown (E-max)?~   "
8835|NCT02941562|"~     The study is designed to analyze the pathological tumor response on locally advanced rectal~     cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy~     combined with short-course radiotherapy in a prospective cohort and to correlate this~     response with patient's outcome~   "
8836|NCT02941549|"~     The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to~     assess the safety and efficacy of orally administered DS102 capsules versus placebo in the~     treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)~   "
8840|NCT02941497|"~     This program is a non-diet approach to obesity prevention for older adolescents which does~     not promote following a special diet to manage weight; instead, it promotes healthy behavior~     associated with obesity prevention. This approach is especially important with youth and~     older adolescent populations so as to avoid impairment in emotional well-being associated~     with body dissatisfaction. Healthy weight status will be achieved by improving dietary~     intake patterns, increasing physical activity, and improving stress management.~      Fall of year 01 was devoted to the recruitment of student partners (intense intervention~     group) and the development of partnerships. In the spring of year 01, recruited students~     were enrolled in two newly developed undergraduate courses across four intervention state~     partners, became collegiate 4-H members, planned a social marketing campaign, and/or learned~     to be peer mentors or student researchers. In year 02, first year college students were~     recruited, peer mentors were matched with a group of first year students, and the developed~     social marketing campaign was pilot tested on four college campuses (diffuse intervention)~     by the collegiate 4-H teams. In year 02, a toolkit with 24 weeks of intervention activities~     was also refined. In year 03, the collegiate 4-H team (intense intervention group) will use~     the refined toolkit to test and implement the intervention on college campuses. In year 03,~     the assessment process for high school 4-H students (intense intervention group) will be~     pilot tested and college students will work with the high school students on adapting the~     toolkit for use in the implementation of the social marketing campaign in high school~     settings in year 04 (diffuse intervention). In year 04, the college tool kit will be~     disseminated to additional college campuses. In year 05, the program will be disseminated to~     additional high schools.~      The nine month interactive, social marketing environmental intervention will aid older~     adolescents in effectively managing weight through increasing healthfulness of diet,~     increased physical activity, and improved stress management behavior as compared to a~     control group. On all measures it is anticipated that participants in the intensive~     intervention group will have greater improvements than those in the diffuse intervention~     group and both intensive and diffuse intervention groups will have improvements over those~     in the control groups.~   "
8841|NCT02941484|"~     Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the~     ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly~     colorectal and gastric. Specific clinical study on early oral intake after PD is very~     limited. inadequate nutritional intake was significantly associated with a high incidence of~     postoperative complications. Therefore, the present study is aim to evaluate the tolerance,~     safety, and efficacy in the patients undergoing PD in the age of ERAS.~   "
8842|NCT02941471|"~     Several transabdominal electrical stimulation studies have been reported for constipation in~     childhood. This study aims to assess the efficacy of this technique in adults with chronic~     constipation and compare two different electrical therapies.~   "
8843|NCT02941458|"~     The GECP, in its commitment to improve the treatment and prognosis of patients with lung~     cancer and other thoracic tumors, has marked the individualization of treatment according to~     the expression of markers predictive of response to chemotherapeutic agents and molecular~     inhibitors of cell proliferation as one of its primary objectives. This could significantly~     improve the prognosis of patients with lung cancer, and will lead to a radical change in~     routine clinical practice. The aim of the register is to explore all data available of all~     patients treated because of thoracic tumours.~   "
8844|NCT02941445|"~     Weight reduction is the most important treatment target in obese women with polycystic ovary~     syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone.~     Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as~     an anti-obesity drug but with some limitations, which include high cost and the lack of~     long-term efficacy and safety data regarding weight reduction. In addition, weight loss~     achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4~     inhibitors are weight neutral, they reduced weight regain in animals previously treated with~     GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to~     evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body~     weight regain more effectively than metformin alone in obese PCOS who had been previously~     treated with liraglutide.~   "
8845|NCT02941432|"~     Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the~     face and present a special therapeutic challenge. Topical corticosteroids that are commonly~     applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they~     may result in rapid atrophy of facial skin and in the long term rather aggravate facial~     dermatoses. Black tea compresses have been successfully used by German-speaking~     dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of~     action is unknown but is presumably based on astringent properties of tannins in the black~     tea and on the antiinflammatory action of a wet compress as such. This therapy is cheap,~     universally available and practically free of side-effects. Despite these perceived~     advantages the effects and tolerance of black tea compresses have not been formally studied~     to date. Therefore, the investigators plan to treat 25 patients with facial eczema/perioral~     dermatitis over a period of 6 days each within the current trial. The disease activity will~     be assessed before, during and after completion of treatment using several clinical scores.~     In addition, side-effects, if any, will be documented.~   "
8846|NCT02941419|"~     Induction of autologous angiogenesis in patients with critical limb ischemia using platelet~     lysate.~   "
8847|NCT02941406|"~     The aim of the present study is to investigate the reproducibility of the MP3 and to compare~     the results with conventional perimetry using the Octopus 101 in healthy subjects and~     patients with macular disease.~   "
8848|NCT02941393|"~     In this study, parturients will be randomized to either internal or external tocodynamometry~     contractions' follow up. Investigators recruit primiparous, those who try to have vaginal~     birth after cesarean section and multiparous, who need oxytocin during labor. Primary~     endpoint is the number of operative labors in each group. Secondary endpoints are the~     duration of labor, the use of oxytocin and the condition of the newborn.~   "
8849|NCT02941380|"~     Purpose:~      The purpose of this study is to examine cerebral oxidative and inflammatory stress and~     cerebral hemodynamics during and after coronary artery bypass grafting and correlate with~     postoperative cognitive function.~   "
8850|NCT02941367|"~     Primary Objective:~      To compare the safety, in terms of percentage of patients with symptomatic documented~     hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).~      Secondary Objectives:~        -  To assess effect of lixisenatide versus SU on:~        -  Changes in glycemic control;~        -  Changes in body weight.~        -  To assess overall safety of lixisenatide and SU.~   "
8851|NCT02941354|"~     This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics~     (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to~     BMI (body mass index) in subjects with haemophilia A.~   "
8852|NCT02941341|"~     Non-comparative, observational, ambispective post-authorisation study (EPA-SP).~   "
8853|NCT02941328|"~     A trial investigating the effects of pyridostigmine (mestinon) versus a placebo in a~     double-blind cross over trial in patients with hereditary proximal spinal muscular atrophy~     (SMA) types 2, 3 and 4.~   "
8855|NCT02941302|"~     Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment~     planning. In particular, the localization of the border zone between tumor infiltrated and~     normal brain tissue is one of the major problems to be solved before beginning therapy.~     However, it is a well known problem that, in conventional magnetic resonance imaging (MRI),~     it often is difficult to detect areas with low tumor infiltration, especially in gliomas,~     because of their infiltrative and often diffuse nature.The study has two purpose:I.To~     correlate the imaging border zone with pathological grade of different tumor site following~     surgery in patients with newly diagnosed intracranial gliomas, work out the biological~     border zone, and complete resect the tumor.II.To determine the feasibility of defining the~     optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and~     functional imaging.~   "
8856|NCT02941289|"~     The aim is to understand which components of attentional deployment and selection are~     impaired in AD during searching in realistic scenes on a computer screen (Experiment 1) and~     in a natural setting (Experiment 2).The investigators will also examine how deficits in~     visual exploration may be related to impairments in semantic, long-term memory (LTM) and~     working memory (WM) representations by manipulating the semantic consistency between the~     target and its visual surroundings, and the type of target cue (abstract vs. precise),~     respectively. Perceptual saliency of target and distractor objects will be also manipulated~     in Expt.1, In Expt.2, in order to determine how deficits in visual exploration may be~     involved in the IADL deficits shown by AD patients, participants at each trial will be~     required to search in a natural settings different types of targets and then to perform an~     IADL using five objects, among which one of the searched targets. Measures analysed: for the~     search tasks (Expt. 1 and 2): eye movements in different search phases, accuracy and~     response times; for IADLs tasks (Expt. 2): eye movements during action planning and~     execution, motor efficiency (number and types of action performed), time to terminate the~     activity. Compared to controls, the investigators expect that AD patients will have reduced~     ability using scene semantic LTM in order to locate the objects, greater attentional capture~     from highly salient features and greater search performance impairment when higher WM~     resources are required (abstract target cues). The investigators also expect that their~     performance at IADLs will be less efficient and, in particular, less organized than control,~     with reduced advantage of eye guidance.~   "
8857|NCT02941276|"~     This trial is looking at using an intra-oral electrostimulating device for the management of~     radiotherapy-induced dry mouth.~   "
8858|NCT02941263|"~     Background:~      Age-related macular degeneration (AMD) affects the macula in the eye. This is the central~     part of the retina. It is needed for sharp, clear vision and activities like reading and~     driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An~     advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive~     cells in the macula die so much that central vision decreases.~      Objective:~      To learn more about geographic atrophy associated with age-related macular degeneration.~      Eligibility:~      Adults at least 55 years old with a certain kind of GA. They must be enrolled in study~     08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies.~      Design:~      Participants will be screened with medical history, physical exam, and an eye exam.~      Participants will have study visits every 3 months for 15 months, then every 6 months. They~     will be in the study almost 4 years.~      Visits will last about 8 hours. At each visit, participants may have:~      Medical and eye history. Participants will answer questions about their general health and~     eye health. They may answer written questions about how their eye problems affect their~     life.~      Eye exam and photographs. Eye pressure will be measured and eye movements will be checked.~     Pupils will be dilated with drops. The thickness of the retina will be measured and photos~     of the eye may be taken.~   "
8859|NCT02941250|"~     Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in~     patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.~   "
8860|NCT02941237|"~     This study is to test the usability of a new pulse oximeter probe designed for children 0-5~     years.~   "
8861|NCT02941224|"~     The primary objective of the Clinical Investigation is to assess the clinical safety and the~     inhibition of restenosis of the Investigational Device in the treatment of de-novo~     occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or~     popliteal arteries.~      The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target~     lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index~     procedure.~   "
8862|NCT02941211|"~     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device~   "
8863|NCT02941198|"~     To compare two intrauterine systems in order to avoid complications originating from short~     pregnancy interval and undesired pregnancies in the early postpartum period.~   "
8864|NCT02941185|"~     Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is~     recommended there is no consensus regarding the adequate dose of supplementation for preterm~     infants.~   "
8865|NCT02941172|"~     This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and~     other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in~     room temperature conditions and during controlled cold exposure, and the density of CB1~     receptors in BAT and other tissues will be quantified. The investigators hypothesize, that~     cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.~      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is~     important and beneficial in fighting against the epidemic of obesity and diabetes.~   "
8866|NCT02941159|"~     The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male~     healthy volunteers~   "
8867|NCT02941146|"~     Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.~   "
8868|NCT02941133|"~     The purpose of this study is to determine the effectiveness of neural mobilization~     techniques compared to standard care treatment in patients with lumbar radiculitis.~   "
8869|NCT02941120|"~     Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject~     in patients with full-thickness cartilage defects in the knee joint.~   "
29249|NCT02674295|"~     The purpose of this study is to determine the metabolic disposition of radiolabeled~     esketamine administered by the oral and intravenous routes in healthy male participants.~   "
8870|NCT02941107|"~     Australian Indigenous children, particularly those living in remote communities, suffer a~     disproportionately high burden of rotavirus gastroenteritis disease. Despite the~     introduction of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in~     2006, the rate of hospitalization for rotavirus in NT Aboriginal children < 5 years~     continues to be high, and the rate ratio of rotavirus hospitalisations for Indigenous versus~     non-Indigenous children has actually increased. The reasons for sub-optimal vaccine response~     are not completely understood, but both reduced vaccine immune responses and low vaccine~     coverage are likely to be important factors.~      The purpose of this study is to determine if Aboriginal children who receive an additional~     dose of RV1 between the ages of 6 and 12 months, will have an increase anti-rotavirus serum~     IgA seroconversion and decreased medical presentations with gastroenteritis in the first~     three years of life, compared to those who receive placebo.~   "
8871|NCT02941094|"~     Ultrasound guidance has been established as an effective and safe method during insertion of~     internal jugular vein catheter.. Needle visualization during advancement toward the vein has~     a great impact on both safety and success of the procedure. Clinicians have adopted variable~     techniques to increase needle visualization including changing needle- probe relation~     (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the~     inserting needle and the probe lying on patient skin affects both the distance to the vein~     and the length of the needle part travelling through the us beam~   "
8872|NCT02941081|"~     This study aims to determine whether IHAT is non-inferior to ferrous sulphate at correcting~     iron deficiency and anaemia, and if IHAT does not increase diarrhoea risk in young children~     living in rural and resource-poor areas of the Gambia.~      The study hypothesis is that IHAT will eliminate iron deficiency and improve haemoglobin~     levels in young children without increasing infectious diarrhoea or promoting inflammation~     in the gut.~   "
8873|NCT02941068|"~     This prospective intended to observe the influence of prophylactic and empirical anti-fungal~     treatment on Severe Sepsis patients with perforations. With the consent of patients' legal~     guardian for prophylactic use of antifungal agents, patients were divided into two groups:~     prophylactic group and Empirical group.~   "
8874|NCT02941055|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the~     population, and where many patients in spite of modern pharmacological treatment fail to~     reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory~     Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will~     decrease disease activity and improve quality of life in patients with established RA.~   "
8875|NCT02941042|"~     Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of~     NNC9204-1177 in Subjects being Overweight or with Obesity~   "
8876|NCT02941029|"~     This research study is being done to develop a new test to identify prostate cancer patients~     at highest risk of radiotherapy-related complications. This research study would allow~     monitoring of total tissue damage within 24 hours of radiation exposure in blood samples~     that could give an initial result within a few days that would help clinicians make~     treatment decisions. Detection of unusual tissue damage at this early time, well before~     symptoms occur, could allow doctors to tailor interventions that could include patient~     therapies that would reduce or prevent the problems that occur due to treatment of their~     cancer.~   "
8877|NCT02941016|"~     This study aim to detect change in vascular inflammation following intense lipid lowering~     therapy~   "
8878|NCT02941003|"~     The purpose of this study is:~        1. To establish a set of diagnostic criteria of intraoperative frozen section of early~          stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.~        2. To assess its clinical usefulness in guiding surgical procedure for early stage lung~          adenocarcinoma.~   "
8879|NCT02940990|"~     This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the~     efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver~     mutations.~   "
8880|NCT02940977|"~     1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients,~          and establish a mathematic model for predicting the pathological status.~        2. To explore the possible subtle change in CTC condition after radical prostatectomy.~   "
8881|NCT02940964|"~     Abstract~      Introduction~      Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of~     survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low.~     Recent studies have proposed and validated the use of popular songs as aids in performing~     CPR. These songs may not be widely known when applied to a different population, and~     further, may lose popularity over time. Count on me Singapore (COMS) is believed to be~     known to over 90% of the Singapore population. Pilot data indicated that CPR performed using~     COMS as a mental metronome (COMSCPR) can achieve guideline-compliant rate of chest~     compression with lower fatigue level than CPR guided by the conventional~     one-and-two-three-and (Standard CPR). The investigators hypothesize that COMSCPR is~     non-inferior to Standard CPR in achieving guideline-compliant rate of chest compression.~      Methodology~      The investigators planned a prospective, randomized, crossover non-inferiority trial~     comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a~     convenience sample of camp personnel from a military training camp. After a 15 minutes~     familiarization session, they will be randomized into two groups (A and B). Group A will~     proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to~     perform one cycle of COMS CPR. participants will cross over to perform one cycle of the~     other method of CPR. After completing this second cycle, a survey form will be administered.~     The Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days~     interval, participants will be recalled to attend a test scenario. Statistical analysis will~     be used to compare the two arms.~   "
8921|NCT02940444|"~     Thromboembolism is an important perioperative complication in major thoracic surgery, even~     though current guidelines have recommended postoperative administration of heparin or LMWH~     for thromboprophylaxis for those high-risk patients, there are still many cases of~     thromboembolism. Therefore, as the guideline itself writes, the investigators believe the~     rational of dose and timing of heparin in thoracic surgery are still not well established.~     Therefore, the investigators aimed to conduct this randomized controlled study to explore~     the safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in~     Major Thoracic Surgery.~   "
8882|NCT02940951|"~     Older adults living with incurable and advancing life-limiting illness frequently desire to~     spend as much time as possible comfortably at home, rather than in hospital. They often have~     complex problems that not only affect their ability to function, but also their and their~     family caregivers' overall quality of life (QOL). Routine assessment of their perceived~     health care needs and their self-reported QOL is necessary to ensure that patients' and~     family caregivers' concerns are visible to home care clinicians so that they can be~     effectively monitored and addressed. These types of assessments involve asking people to~     respond to questions about their symptoms, their physical, psychological, social and~     existential/spiritual wellbeing, and their experiences with the care provided. Handheld~     electronic information systems are increasingly used and recommended to facilitate such QOL~     assessments. However, there is a need for information about how such systems are best~     translated into practice improvements that ultimately may improve patient- and~     family-centred outcomes.~      This study is about the implementation of an electronic tablet-based innovative health care~     information system, the Quality of life Assessment and Practice Support System (QPSS), into~     routine care provided by home care services for older adults with life-limiting illnesses~     and their family caregivers. Nine home care sites in Canada are participating. At each site~     the investigators will first adapt the QPSS to the local context and develop a plan for its~     local implementation. Then home care staff will be asked to use it in practice and the~     investigators will evaluate the process of using the QPSS and its effect on patient and~     family caregiver quality of life, health, and satisfaction with care as well as the cost~     consequences of its integration into practice. The effect of its use will be studied in a~     randomized trial, which is the part of the study described in this registry. Patients and~     their family caregivers will be randomly assigned to 1) have their home care team use the~     QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using~     the QPSS will be measured using questionnaires completed by the participating patients and~     family caregivers every two months. If using the QPSS improves quality of life, health, or~     satisfaction with care, the last stage will explore how to scale up use of the QPSS in~     practice and its integration with existing health information systems.~   "
8883|NCT02940938|"~     The purpose of this study is to evaluate the variations of respiratory changes in pulse~     oximeter plethysmographic amplitude (delta POP) according to different contact forces~     between finger and sensor of pulse oximeter. During general anesthesia without surgical~     stimuli, pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N~     (increased by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be~     calculated and compared.~   "
8884|NCT02940925|"~     The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND~     CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with~     concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in~     endemic area.~   "
8885|NCT02940912|"~     The purpose of the study is to demonstrate that continuous apomorphine treatment during the~     night compared with placebo improves sleep quality in insomniac patient with Parkinson's~     disease.~   "
8886|NCT02940899|"~     Syracuse University Fit Families is designed to increase the activity level and frequency of~     the children through modified activities using adapted equipment and, importantly, to~     increase the families' comfort level in having their children participate in a variety of~     physical activities, including team and individual sports.~   "
8887|NCT02940886|"~     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects~     suffering from IDA~   "
8888|NCT02940873|"~     Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood~     sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel~     when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH),~     increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe~     hypoglycaemia reduced when people are taught how to adjust their insulin around their~     life-styles through structured education but problematic hypoglycaemia may persist. Many~     people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts~     about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot~     benefit from conventional treatments to reduce hypoglycaemia. The investigators developed~     the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and~     problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel~     intervention that combines revision of knowledge about hypoglycaemia avoidance with~     psychological therapies that directly address unhelpful health beliefs about hypoglycaemia.~     HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot~     study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and~     recurrent severe hypoglycaemia.~      The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an~     established educational intervention (Blood Glucose Awareness Training, BGAT) which has also~     been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic~     hypoglycaemia persisting despite otherwise optimised insulin self-management will be~     recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4~     centres. The investigators will measure severe hypoglycaemia over two years following~     courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.~   "
8889|NCT02940860|"~     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects~     with IDA and NDD-CKD.~   "
8890|NCT02940847|"~     The axillary brachial plexus block is a technique of locoregional anesthesia indicated in~     the distal upper limb surgery : hand, forearm, the lower third of the arm including the~     elbow. The anesthesia of the posterior and the medial side of the arm requires a selective~     block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example~     to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two~     techniques to achieve this block : the blind technique (without ultrasound) and the~     ultrasound-guided technique. At the moment, there are no studies which compare these two~     techniques. So, the purpose of this study is to determine the effectiveness of~     ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve~     block and intercostobrachial nerve block, in the axilla.~   "
8891|NCT02940834|"~     Observational study about prevalence, predictors of sodium imbalance and prognostic~     significance.~   "
8892|NCT02940821|"~     Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening:~     A randomized, person-centric, comparative effectiveness clinical research study by the~     Practitioners Engaged in Applied Research and Learning (PEARL) Network.~   "
8893|NCT02940808|"~     Cognitive control driven by the prefrontal cortex (PFC) of the brain is thought to be~     important for goal-directed control over stimulus-driven processes. EEG-measured spontaneous~     theta/beta ratio (TBR) may potentially be used as an electrophysiological marker for this~     PFC-mediated cognitive control. In the present study the investigators further examine TBR~     as an electrophysiological marker for cognitive control, by administering caffeine to forty~     healthy female participants. After a first training session, participants will visit the lab~     twice in separate weeks, during which they will orally consume one capsule containing 200mg~     of caffeine, and one capsule containing a placebo substance (double-blind and random order~     of administration). EEG will be measured before and after capsule consumption, and cognitive~     control tasks will be administered after capsule consumption. Generally, the investigators~     expect that caffeine will decrease TBR and thereby increase cognitive control. Additionally,~     the investigators expect that individual differences in baseline frontal (reflected by TBR)~     and central dopaminergic (reflected by spontaneously-measured eye-blink rates; EBR) activity~     will moderate the relationship between caffeine and cognitive control. Furthermore, the~     effects of caffeine on specifically hypervigilance for threatening distractors (taking into~     account a possible moderating role of trait anxiety) were examined as a separate research~     question.~   "
8894|NCT02940795|"~     The majority of pregnant women in the United States are either overweight or obese at~     conception with their offspring having greater adiposity at birth, a 2-fold greater risk of~     later obesity and neonatal insulin resistance.~      Conventional wisdom holds that breast-milk composition is uniform; recently our group has~     questioned this. An increase in consumption of dietary sugars including fructose over the~     past 30 years has risen, and this has been associated with chronic metabolic and endocrine~     disorders and phenotypic alterations that promote obesity and diabetes. However, no prior~     studies have examined how maternal increases of sugars/fructose during lactation affects~     breast-milk composition with potential transmission to the infant. The objective of this~     proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including~     fructose in human breast-milk in response to maternal consumption. The central hypothesis is~     that a graded, dose-response relationship be-tween maternal adiposity and sugar~     concentrations in breast-milk exist and that milk fructose concentrations are associated~     with altered body composition in the first months of life. This proposal, guided by~     compelling preliminary data will examine the evidence linking high intakes of milk fructose~     with altered metabolism and early obesity by pursuing two Specific Aims: 1) Test novel~     relationships between breast-milk sugars and changes in infant fat mass and 2) Characterize~     the pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are~     significant given the intractability of obesity/diabetes and a potentially identifiable~     novel target, making for a clear but powerful public message to reduce sugary beverage~     consumption during lactation.~   "
8895|NCT02940782|"~     A randomized clinical trial to assess postoperative pain in patients with symptomatic~     irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.~   "
8896|NCT02940769|"~     The primary study objective is to observe/measure the circadian pattern of sleep, Cortisol~     and Melatonin in MDD subjects and Control subjects. We will also assess if controlled~     exposure to light in MDD subjects (post-partum females, non- post-partum females and males)~     will change these parameters using light glasses. In addition to the biological outcome~     measures (sleep, cortisol and melatonin) we will also monitor sleep and depressive symptoms~     in the research subjects for the duration of the protocol.~   "
8897|NCT02940756|"~     The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria~     in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to~     play a major role in the malaria control in the region. The National Malaria Control program~     recommends artemisinin-based combination treatments (ACTs), in particular~     artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated~     malaria. Previous studies indicated that ACTs are still effective, with efficacy above the~     required threshold of 90%. It is required to assess regularly the efficacy of antimalarial~     drugs, in order to ascertain the relevance of treatment guidelines such that, in case of~     increasing failure rates, alternative options can be decided ontime.~      The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ~     Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and~     dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated~     Plasmodium falciparum malaria in six surveillance sites around DRC.~   "
8898|NCT02940743|"~     The purpose of this randomized clinical trial is to evaluate alternative~     technology-supported behavioral approaches to engaging 42 maintenance hemodialysis (HD)~     patients with persistent hyperphosphatemia in phosphorus binder adherence and dietary~     phosphorus restriction. Participants will be randomized to 1 of 3 intervention groups: (1)~     Education (Edu); (2) Edu + Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory~     (SCT)-based training program.~   "
8899|NCT02940730|"~     This study will evaluate the pharmacokinetic properties of dalbavancin when administered as~     an intravenous infusion and instilled into the peritoneal space in patients who are~     undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed~     by intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the~     patients will then receive dalbavancin instilled into their peritoneal space followed by the~     same intensive plasma and peritoneal dialyses fluid sampling.~   "
8900|NCT02940717|"~     Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic.~     Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material~     with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and~     laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be~     used to fabricate laminate veneers but the investigators have to know clinically it is~     fracture resistance, so the investigators are going to have Parallel groups in a randomized~     clinical trial.~   "
8901|NCT02940704|"~     -  The aim of this study is to assess the postoperative pain and the intake of analgesic~          medication after using Reciproc single-file reciprocating system or One Shape~          single-file continuous rotary system in patients with symptomatic irreversible~          pulpitis.~        -  Patients will be diagnosed to determine whether they are eligible for the inclusion~          criteria of this study or not. Patients who are eligible will then start their root~          canal treatment on the same visit and to be completed in one visit only. Patients will~          be phone called in order to record the intensity of pain, amount and frequency of~          analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.~   "
8902|NCT02940691|"~     This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess~     whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus~     (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who~     inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4~     infection.~   "
8922|NCT02940431|"~     The purpose of this study is to look at the effects of active video game play on youth~     physical activity.~   "
8923|NCT02940418|"~     Allogenic adipose derived mesenchymal stem cells will be injected into patients newly~     diagnosed with type 1 Diabetes Mellitus~   "
8924|NCT02940405|"~     The aim of this study to assess effect of ketorolac premedication on the effectiveness of~     the inferior alveolar nerve block, pretreatment and postoperative pain in patients with~     symptomatic irreversible pulpitis.~   "
8925|NCT02940392|"~     Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering~     from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).~   "
8903|NCT02940678|"~     Trauma is one of the top threats to population health globally. A substantial body of~     research has been devoted to the development of clinical prediction models to aid early~     decision making in trauma care. Often these models are applied outside the context in which~     they were originally developed. In contrast, very little research has focused on the effects~     on model performance of such transfers despite the fact that a potential loss in performance~     could have devastating consequences.~      Data from the Swedish trauma registry SweTrau will be used to study the effects on model~     performance of transfers between different contexts within a single conceptually homogenous~     setting. Using logistic regression models for predicting all-cause mortality within 30 days~     of trauma in adult patients will be developed, focusing on systolic blood pressure,~     respiratory rate, and Glasgow coma scale as predictors.~      Four different sets of data sampled from SweTrau will be used to simulate transfer of models~     between high and low volume centres, metropolitan and non-metropolitan centres, multicentre~     and single centre data, and finally between individual centres. Measures of overall~     performance, clinical usefulness, discrimination, calibration, and recalibration will be~     used to quantify the effects on performance of model transfers.~      The study will provide evidence to help clinicians and policy makers in deciding on whether~     it is appropriate to apply models developed in other contexts. For example, the results of~     this study may inform decisions on the development and implementation of models intended to~     be applied on a national or regional level, and ultimately help designing better trauma care~     and improve the outcomes of trauma patients.~   "
8904|NCT02940665|"~     The primary objective of this prospective cohort study is to compare protein intake and~     adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with~     patients receiving conventional care. The study will also compare energy intakes, gut~     function, and clinical outcomes between groups. The ability of nutritional parameters,~     including preoperative malnutrition risk and postoperative protein intake, to predict length~     of hospital stay will be evaluated.~   "
8905|NCT02940652|"~     The aim of the trial is to obtain and to describe the position of the laryngeal mask during~     elective magnetic resonance imaging in paediatric patient. The radiologic findings will be~     compared to the clinical performance of the laryngeal mask.~   "
8906|NCT02940639|"~     A Real-Life Study to Evaluate Efficacy and Safety of Nivolumab in Patients with Advanced~     Renal Cell Carcinoma after prior therapy.~   "
8907|NCT02940626|"~     The purpose of this study is the prevention of Staphylococcus aureus pneumonia in~     mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is~     a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.~     Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including~     ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a~     significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is~     an investigational monoclonal antibody product that targets the toxins produced by S. aureus~     to protect subjects from developing S. aureus pneumonia.~   "
8908|NCT02940613|"~     This study has two aims: 1) to test the validity of an eating disorder symptom checklist~     against an established clinical interview; and 2) to examine whether providing eating~     disorder patients with visual graphs of their symptom frequency in the early sessions of~     active treatment will lead to higher numbers of patients achieving a rapid response (65%~     reduction in symptoms in the first 4 weeks of treatment). Groups where patients receive~     visual graphs of symptom frequency will be compared with groups where patients do not~     receive visual graphs of symptom frequency on rates of rapid response to cognitive behavior~     treatment for eating disorders.~   "
8909|NCT02940600|"~     The purpose of this study is to evaluate the impact of normothermic machine perfusion in~     liver transplantation using grafts of brain death donors older or equal than 70 years~   "
8910|NCT02940587|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated~     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)~   "
8911|NCT02940574|"~     The current trial aims to explore the neural and behavioral effects of oxytocin in autism~     spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and~     supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of~     complex social behaviors. Initial studies showed that intranasal administration of oxytocin~     can have a positive effect on social functioning in ASD.~      However, future studies are necessary to explore whether and how oxytocin effects neural~     processes in the brain underlying these behavioral improvements. This trial will not only~     measure behavioral enhancements, but will specifically focus on elucidating the associated~     neurophysiological changes by guiding the administration of oxytocin with regular~     neurophysiological assessments.~   "
8912|NCT02940561|"~     To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP,~     2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product -~     Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. in patients with~     mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of~     2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their~     bioequivalence.~   "
8913|NCT02940548|"~     This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood~     pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper~     hypertensives. Half of participants will receive Nifedipine GITS, half of half will take~     medicine in the morning or at night. While the other half participants will take amlodipine~     besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory~     blood pressure monitoring and arterial stiffness examination will be performed before and~     after pharmaceutical intervention.~   "
8914|NCT02940535|"~     The management of the poor responder patients is very difficult. Currently, there is no any~     standard treatment for poor responder patients. The study is designed to test a modified~     GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation,~     compare with GnRHa ultra-short protocol. This is a randomized controlled trial.~   "
8915|NCT02940522|"~     To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable~     bioavailability to a single IM injection of Makena®.~   "
46842|NCT02443909|"~     To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm~     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).~   "
8928|NCT02940353|"~     Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the~     treatment of edentulous or patients with failing mandibular dentition over 5 years. 90~     patients (15 per centre) will be included. The subject population is at least 18 years old,~     in need of an implant restored full prosthesis providing sufficient bone in the~     interforaminal where a fixed restoration on three implants is regarded as an appropriate~     treatment solution. The components are TREFOIL treatment concept (implants and framework).~   "
8929|NCT02940340|"~     Infective endocarditis (IE) is a severe clinical condition with a high in-hospital and~     5-year mortality. It has a growing incidence, both related to healthcare and possibly to~     changes in prophylaxis recommendations regarding oral procedures. Though not a new disease,~     several aspects in its clinical and laboratory diagnosis remain to be better studied and~     innovated. The evaluation of systemic microvascular disease has proven crucial in the~     investigation and comprehension of pathophysiology of cardiovascular diseases, as well as a~     tool for early diagnosis and prediction of complications. Few studies deal with~     microcirculation in patients with IE, and so far none utilizing speckle contrast imaging and~     functional capillary density. The present study will contribute to the investigation of~     microcirculatory changes in IE and possibly to earlier diagnosis of the condition and/or of~     its severity and complications. The aim of the study is to evaluate the changes in~     microvascular bed of patients with both acute and subacute endocarditis by speckle contrast~     imaging and skin video-capillaroscopy.~   "
8930|NCT02940327|"~     Respiratory failure in newborns is common and has high rates of death. Where conventional~     intensive care strategies have failed, newborn children are referred to treatment with~     Extra- Corporeal Membrane Oxygenation (ECMO). This involves connecting children via large~     bore cannulas placed in their heart and major blood vessels to an artificial lung that adds~     oxygen to their blood and removes waste gases (carbon dioxide). Although this treatment~     saves lives, it still has some limitations. In particular, severe complications like~     bleeding, or damage to the kidneys can occur. These complications can lead to death in some~     cases and long-term disability in others. Based on ongoing research in adults and children~     undergoing cardiac surgery the investigators have identified a new process that may underlie~     some of the complications observed in ECMO. The investigators have noted that when~     transfused blood is infused in an ECMO circuit, this results in the accelerated release of~     substances from the donor cells that cause organ damage; at least in adults. There are~     treatments that can reverse this process. Before the investigators explore whether these~     treatments should be used in newborn children on ECMO, the investigators must first~     demonstrate that they can measure the complex inflammatory processes that occur in these~     critically ill children. The investigators therefore propose to conduct a feasibility study~     to identify the practical issues and challenges that would need to be overcome in order to~     perform a successful trial in this high-risk population.~   "
8931|NCT02940314|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics after~     administration of HIP1503 and HGP1103 in healthy male volunteers.~   "
8932|NCT02940301|"~     This phase II trial studies how well ibrutinib and nivolumab work in treating patients with~     classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by~     targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients~     with classical Hodgkin lymphoma.~   "
8933|NCT02940288|"~     Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at~     particular locations called acupoints. Although the mechanism for acupuncture analgesia is~     still unclear, it is believed ear acupoints work like reflex points that once stimulated~     with penetration by a needle have the ability to relieve pain in a different part of the~     body.~      The purpose of this study is to explore the safety and effects of auricular acupuncture~     therapy on postoperative analgesic consumption and pain scores immediately following~     laparoscopic surgery.~   "
8934|NCT02940275|"~     This is an observational clinical study, patients with systemic diseases will be enrolled~     according to the inclusion and exclusion criteria. Patients will received the examination of~     sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius~     Battery Powered Transilluminator). The microcirculation data includes total small vessel~     density, perfused small vessel density, microvascular flow index, and heterogeneity index.~     The patients will be divided into right groups according to their systemic diseases as~     follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3~     hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis~     (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and~     group 7 peripheral arterial occlusive disease (60).~   "
8935|NCT02940262|"~     This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography~     (PET)/computed tomography (CT) works in detecting prostate cancer that has come back in~     patients after initial therapy. Diagnostic procedures, such as 68Ga-PSMA-11PET/CT, may help~     doctors detect tumors that have come back after initial therapy.~   "
8936|NCT02940249|"~     Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within~     the body and eventually lead to the development of type 2 diabetes. Previous research by~     this group has shown that an apple polyphenol extract reduced hyperglycaemia following a~     high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses~     of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory~     polypeptide concentrations following a mixed carbohydrate test meal.~   "
8937|NCT02940236|"~     To assess possible risk of aspiration with pre-operative oral medications taken with sips~     of water (100ml).~   "
8938|NCT02940223|"~     The goal of this clinical research study is to learn about the effects of combining physical~     activity with fish oil to treat fatigue in patients with advanced colorectal cancer~     receiving regorafenib.~   "
8939|NCT02940210|"~     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy~     and safety of adhesion barrier Mediclore versus no treatment in patients with total~     thyroidectomy~   "
9710|NCT02930161|"~     The study is designed to assess the safety and efficacy of different doses and dosing~     regimens of Runihol, tablets, enteric coated, produced by NTFF POLYSAN (Russia), in~     prevention of liver disease progression in patients with non-alcoholic fatty liver disease~     and metabolic syndrome.~   "
8940|NCT02940197|"~     Background: Obesity treatment should be individualized since some calorie restricted diet~     doesn't work for some individuals.~      Objective: we assess the effect of two different calorie restriction with MediterrAsian diet~     on weight loss of FTO rs9939609 carriers with overweight.~      Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly~     allocated in two interventional group [group 1: Mediterrasian diet according to adjusted~     ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories~     restriction (NRD)+ Moderate physical activity]. Anthropometric indices will be assesses for~     all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly.~     Metabolic indices, physical activity and psychologic aspects will be assesses at baseline~     and the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0,~     30 and 60. At the end of the study, we compare carriers with different alleles (AA+TA and~     TT) in two intervention groups to find out which calorie restriction is appropriate for each~     genotype. Significant p-value is less than 0.05.~   "
8941|NCT02940184|"~     Investigation of the importance of vagal signaling for the glucohomeostatic effects of~     GLP-1. The study will include physiological studies of truncally vagotomized participants~     and matched controls.~   "
8942|NCT02940171|"~     Prognosis of burn patients has improved over the last decades. Early excision of full~     thickness burns is thought to be one of the key factors which have led to prognostic~     improvement. Best timing for burn excision remain uncertain however. In this multicenter~     observational study, we aim at exploring the impact of timing of surgery on outcome in~     severely ill patients using a propensity analysis.~   "
8943|NCT02940158|"~     The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup~     servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of~     starchy foods (corn, macaroni, white potato, white rice).~   "
8944|NCT02940145|"~     The main purpose of the present study was to investigate the effects of 12 weeks of~     resistance training (RT) on phase angle (PhA), body composition, inflammatory and oxidative~     stress biomarkers, in older women and to evaluate whether RT induced adaptations on body~     composition, inflammatory and oxidative stress biomarkers are related to healthy adaptations~     in PhA.~   "
8945|NCT02940132|"~     SC10914 is a potent selective PARP-1 and PARP-2 inhibitor. This study aims to determine the~     safety , tolerability , pharmacokinetic/pharmacodynamics profile of increasing doses of~     SC10914 when administered orally to patients with advanced solid tumors. Furthermore, the~     safety and efficacy of SC10914 in patients with advanced solid tumors and negative~     expression of ATM or BRCA1 or BRCA2 mutation will be evaluated in expanded cohorts to~     establish the Recommended Phase 2 Dose(RP2D).~   "
8946|NCT02940119|"~     Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant~     number of individuals.The aim of this study is to evaluate the effects of PBMT (with a~     device that combines low level laser therapy and light emitting diode therapy) in chronic~     pain relief of musculoskeletal origin in the neck and shoulders area.~   "
8947|NCT02940106|"~     This randomized pilot study will assess if there is a difference in clinical pregnancies~     using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.~   "
8948|NCT02940093|"~     The combined analysis of microbiome, immunological parameters and host genetics in patients~     has potential for applying personalized approaches of prevention, diagnostics or therapy in~     the future. However, the acquisition and analysis of these patient characteristics in a~     scientifically sound, technically reliable, cost-effective, practicable and future-oriented~     fashion are a far from trivial task. Therefore the objectives of the study are (i) to~     optimize a sample and data acquisition and analysis pipeline that fulfills these criteria~     (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children~     undergoing stem cell transplantation, yielding information on host immuno-genetics, gut~     immune function and the human gut microbiome; (iii) deduct the most critical parameters for~     host-microbiome interplay from this complex dataset.~   "
8949|NCT02940080|"~     A randomized, single-blind cross-over clinical nutrition trial will be conducted. The~     effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with~     anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia~     and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites,~     and the appearance and metabolism of the flavonoids and their metabolites is studied in~     plasma, urine and feces.~   "
8950|NCT02940067|"~     This is a pilot study to investigate the effect of prehabilitation on patients undergoing~     elective surgery for pancreatic disease.~   "
8951|NCT02940054|"~     Observational prospective study to validate a new index for early diagnosis of Crohn's~     disease (CD)~   "
8952|NCT02940041|"~     Determine the concordance between gynaecological sonography and pelvic MRI for the~     pre-surgical diagnosis of uterine malignant tumors.~   "
8953|NCT02940028|"~     The ICU is a stressful and challenging place for patients and their families. Many family~     members experience anxiety, depression, and posttraumatic stress disorder during and after~     their ICU experience. The investigators are studying post-traumatic growth in this study.~     Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or~     difficult life experience. This study investigates the effects of expressive writing on~     positive changes that occur after a difficult experience .PTG will be compared between the~     intervention group receiving the expressive writing intervention and the control group~     (non-expressive or fact based writing).~   "
8966|NCT02939859|"~     Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived~     cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via~     intravascular system of quality of life and alteration of documented Muscular Sclerosis (MS)~     and related neurodegenerative patients. It is believed that the heterogeneous cell~     population which includes multipotent stem/stromal cells are capable of immune~     modulation/inflammatory modulation properties. Exam of disease progression and quality of~     life changes will be evaluated.~   "
9043|NCT02938858|"~     The registry aims to compare the two first-line available treatment approaches in~     non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in~     terms of practitioner's choice between the two options, clinical effectiveness and~     cost-effectiveness, long-term outcome, and short- and long-term toxic effects.~   "
8954|NCT02940015|"~     Background:~      Scientists want to improve new studies on how the environment, diet, and genetic factors~     affect human health. To do this, they need biological samples and clinical data. They want~     to find better ways to collect, handle, store, and test these samples and data. This could~     make them more useful for research.~      Objective:~      To collect anonymous samples and clinical data from people. To find better ways to collect,~     handle, store, and test them to support health research.~      Eligibility:~      Healthy people ages 18 and older~      Design:~      Participants will complete a screening form by phone or in person. The form could include~     questions about age, race, ethnicity, menopause status, or pregnancy.~      Participants will donate a specific amount of a sample. This could be blood, breast milk,~     cerumen, ear wax, exhaled breath, hair, mucosal or skin cells, nail clippings, saliva,~     semen, stool, or urine.~      Participants may provide an environmental sample such as dust, water, soil, air, or plant~     life.~      Participants may get kits to collect their samples. They may also donate them at a clinic~     visit.~      Visit will take about 30 minutes. They may include:~      Sample collection~      Questions about diet, smoking, alcohol use, medication, menstrual cycle, and health~      Measurement of body composition, naturally occurring radioactivity, or Doppler blood flow~      Moderate exercise~      Flexibility, muscle strength, or sensory testing~      Participants may be asked to participate several times during the study.~   "
8955|NCT02940002|"~     To explore the efficacy and safety of four BAY1003803 formulations by means of a within~     subject comparison in an open Psoriasis Plaque Test~   "
8956|NCT02939989|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV)~     genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic~     participants) who have experienced virologic failure in an AbbVie parent clinical study.~   "
8957|NCT02939976|"~     Patients with partially blocked blood vessel(s) in their heart may need a medical procedure~     called Percutaneous Coronary Intervention (PCI) to open the narrowed blood vessel(s). The~     purpose of this study is to simultaneously address four potential advances in ST-Elevation~     Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are~     looking to see if these advances can improve the outcome for these patients.~        1. Opening the arteries with a Medtronic stent~        2. Radial access (from wrist) success with a Medtronic stent~        3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide~          wires.~        4. Reduced bleeding and vascular complications with radial arterial access for primary PCI~          in STEMI.~   "
8958|NCT02939963|"~     Patients who are intubated and mechanically ventilated for acute respiratory failure in the~     Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean~     them from mechanical ventilation is to screen criteria for feasibility and, if present, to~     test feasibility by performing spontaneous breathing trial. This latter can be done either~     by setting a low pressure support level (expected to compensate the airflow resistance due~     to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube~     without any support from the ventilator. Combination of low pressure assistance strategy (7~     cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit.~     Such a low pressure support level should actually result in a real assistance and, hence~     this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators~     offer the option of compensating for the airflow resistance due to endotracheal tube,~     automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients~     ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients~     are breathing spontaneously through the endotracheal tube and are connected to the~     ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.~      Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm~     H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work~     of breathing. The hypothesis is that the power of the work of breathing is greater in ATC~     than in the usual procedure, and hence this latter is a real ventilator support.~   "
8959|NCT02939950|"~     The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb~     samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared~     to the Bausch + Lomb PureVision® contact lens when worn for 7-day extended wear by adapted~     soft contact lens wearers.~   "
8960|NCT02939937|"~     Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it~     presents as subacute monocular visual loss that develops over several days.~      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term~     beneficial effect on vision.~      There are a number of factors that contribute to nerve fibre damage including increased~     level of sodium, so blocking sodium entry could help to protect them against damage.~      The main objective of the study is determine whether phenytoin (which blocks sodium entry)~     can protect nerve fibre and improve final visual function after optic neuritis.~   "
8961|NCT02939924|"~     To assess safety and efficacy of the Kanshas DCB in the treatment of de novo lesions in the~     superficial femoral (SFA) and/or popliteal arteries.~   "
8962|NCT02939911|"~     Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative~     morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not~     known. The aim of this prospective observational cohort study is to evaluate the early RNB~     just before extubation and late RNB at the time of arrival to postanesthetic care unit~     (PACU).~   "
8963|NCT02939898|"~     The goal of this project is to identify autocrine, paracrine and endocrine factors which are~     associated with intercycle variation in cyclical follicle recruitment.~      Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the~     stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or~     placebo during ovarian stimulation.~   "
8964|NCT02939885|"~     The purpose of the study is to better define and understand the brain mechanisms related to~     emotional and cognitive dimensions using odorous stimuli, gustatory stimuli, visual stimuli~     and auditory stimuli using functional Magnetic Resonance Imaging (fMRI).~   "
8965|NCT02939872|"~     The purpose of this study is to evaluate optimal duration of clopidogrel therapy after~     Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic~     events.~   "
8967|NCT02939846|"~     Present clinical study will be conducted in China to evaluate the pharmacokinetics of single~     and repeat oral doses of trametinib, the safety profile and the clinical activity in Chinese~     subjects with solid tumor. Approximately 10 evaluable subjects will be enrolled in the~     study, Subjects will receive trametinib 2 mg once daily (QD). Study treatment will continue~     until disease progression, death or unacceptable toxicity. The study will be completed after~     all subjects have discontinued from study treatment or last enrolled subject has had at~     least 16 weeks of follow-up, whichever occurs first.~   "
8968|NCT02939833|"~     Patients undergoing meningeoma resection surgery will be randomly assigned to two groups.~     One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group~     will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before~     skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at~     before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of~     pain-control medicine and NRS score at the first three days after surgery, ratio of~     intracranial infection within 30d after surgery, and total hospitalization days and medical~     expenditure will also be recorded and compared between the two groups.~   "
8969|NCT02939820|"~     The purpose of this study is to provide expanded access of patisiran to patients with~     hereditary transthyretin-mediated amyloidosis (hATTR).~   "
8970|NCT02939807|"~     This is a Phase II efficacy study of single agent ABC294640. Patients with advanced~     hepatocellular carcinoma (HCC) who have experienced tumor progression with 1st line single~     agent sorafenib will receive ABC294640 500 mg po bid continuously.~      Patients will continue on therapy until the development of progressive disease per modified~     RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in~     patient discontinuation.~   "
8971|NCT02939794|"~     Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under~     went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood~     transfusion) and more than 80% of the patients receives at least one unit of red blood cell~     transfusion.~      There were number of attempts to prevent the postoperative anemia by giving erythropoietin,~     Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after~     the cardiac surgery.~   "
8972|NCT02939781|"~     Fever is part of the body's immune response, often triggered by infection. Fever is commonly~     treated with medicines such as paracetamol, mainly because people feel unwell with fever.~     However fever does have a role in fighting infection: it enables the rest of the immune~     system to function more efficiently, and may directly stop bacteria and viruses from~     multiplying. In most cases however treating fever does not matter because the rest of the~     immune system can cope well enough to fight the infection (with or without additional~     treatment, like antibiotics).~      In critically ill patients however any advantage in the fight against infection may be~     crucial. In a large observational study of adult patients in the intensive care unit,~     patients who developed an early fever with temperature between 38.5-39.5 degrees C fared~     relatively better than patients who were colder. So it is possible that in critical illness~     fever may be beneficial. However in critical illness the body does have limited energy~     resources. In order to raise the body temperature energy is required. However the~     investigators do not know how much energy is required to generate a fever in critically ill~     children. This study will aim to try and measure the energy required to generate a fever in~     a critically ill child. The investigators will measure energy expenditure directly in~     children admitted to the intensive care unit by measuring the levels of oxygen and carbon~     dioxide they breathe in and out (a method called indirect calorimetry). This will enable the~     investigators to judge whether the benefits of a fever can be justified by the energy costs~     in the energy depleted state that is critical illness.~   "
8973|NCT02939768|"~     Background: Type 1 diabetes mellitus (T1DM) is characterized by the destruction of β cells~     and consequent loss of insulin secretion due an autoimmune process, being associated with~     increased cardiovascular risk, oxidative stress and inflammation.~      Considering that most people with T1DM do not reach recommended levels of physical activity~     due to concern about the rapid drop in blood sugar and the excuse of lack of time, shorter~     sessions of exercise that provide several benefits should be encouraged. Thus, this work~     aims to compare the effects of high-intensity interval training (HIIT), strength training~     (ST) and both interventions on several blood markers and functional parameters in T1DM~     patients.~      Study hypothesis: (1) ST+HIIT will be more beneficial than HIIT, which in turn will be more~     beneficial than ST, on modification of blood levels of pro and anti-inflammatory, pro and~     antioxidant, lipid, renal and glucose metabolism parameters and (2) ST+HIIT will be more~     beneficial than HIIT, which in turn will be more beneficial than ST, on modification of~     functional parameters, body composition and maximal oxygen uptake.~   "
8974|NCT02939755|"~     To test the efficacy of a web-based stepped collaborative care intervention to reduce~     symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL)~     in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors~     in caregivers.~   "
8975|NCT02939742|"~     The purpose of this study is to determine if a repeat course of betamethasone given to~     pregnant women with preterm premature rupture of membranes (PPROM) will decrease the~     infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal~     morbidity associated with this condition.~   "
8976|NCT02939729|"~     The purpose of this study is to determine the effects of a physiotherapy prehabilitation~     programme (walking and deep breathing exercises) in cardiac or thoracic patients by~     measuring changes in lung volumes, functional capacity physiotherapy length of stay~     postoperatively.~   "
9013|NCT02939248|"~     The purpose of this study is to evaluate differences in the pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite between patients who received~     ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and~     morphine alone for unstable angina pectoris.~   "
9014|NCT02939235|"~     The purpose of this study is to evaluate differences in the pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite between patients who received~     ticagrelor and morphine followed by metoclopramide versus patients treated with ticagrelor~     and morphine alone for unstable angina pectoris.~   "
9733|NCT02929862|"~     This is a Phase 1/2a study designed to evaluate the safety and tolerability of increased~     repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.~   "
8977|NCT02939716|"~     When patients have bowel surgery they are sometimes left with a stoma, where the small bowel~     exits onto the wall of the abdomen, not into the colon. Certain foods have been shown to~     increase the amount of water lost through a stoma. This can lead to dehydration. Such~     patients are encouraged to avoid such foods but knowing which ones to avoid relies partly on~     trial and error.~      In a survey 1 in 3 patients said that rhubarb increased stoma output. Rhubarb is known to~     contain chemicals that can stimulate the bowel. 1 in 6 patients also reported the same~     effect with lettuce which has not previously been shown to have such an effect. Latex found~     in lettuce leaves may stimulate the bowel to produce more fluid, explaining this effect.~      In Nottingham the investigators have developed techniques that use Magnetic Resonance~     Imaging (MRI) to measure water in the small bowel. They want to use these techniques to~     explore whether eating lettuce increase small bowel water content. They will compare lettuce~     to rhubarb and to bread, which they know reduces small bowel water. They will see if they~     can detect any relationship between water in the bowel and feelings of bloating.~   "
8978|NCT02939703|"~     The purpose of this study is to collect data to examine how diet impacts the composition and~     function of the bacteria in your large intestine.~   "
8979|NCT02939690|"~     In this randomized clinical study, neonates who require umbilical venous catheter (UVC)~     insertion as part of their routine care at anytime during their NICU admission will be~     randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus~     to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) +~     9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the~     UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the~     investigators will do a ultrasound of the heart to assess the exact location of the catheter~     tips as soon as possible but within 6 hours of insertion.~   "
8980|NCT02939677|"~     Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in~     about 2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft)~     have persistent hamstring strength deficiency when evaluated more than 1-2 years after~     ACL-reconstruction. The investigators have designed this randomized controlled trial (RCT)~     with the main purpose to investigate the effect of a targeted muscle strength exercise~     intervention on the neuromuscular rehabilitation of ACLR-patients compared with 'care-as-~     usual'.~      The study is designed as a prospective, superiority, parallel-group with balanced~     randomization (1:1) RCT (Level of evidence: II) with blinded allocation, and outcome~     assessment according to the CONSORT statement (Consolidated Standards of Reporting Trials).~     50 patients with ACL reconstruction and persistent hamstring muscle deficiency, will be~     recruited at the outpatient clinic 1-year follow-up, and allocated to one of two 12 weeks'~     interventions, either a) the supervised progressive strength and neuromuscular exercise~     group (SNG) with supervised training twice weekly. Or b) the control group (CON) receiving~     patient education based on a home-based exercise regime of low intensity, defined as 'care~     as usual'. Outcome measures include, maximal isometric knee flexor muscle strength (primary~     outcome), knee extensor strength, and the Knee injury and Osteoarthritis Outcome Score~     (KOOS) (secondary outcomes). In addition, the following explorative outcomes will be~     investigated; hamstring to quadriceps strength ratios, the International Knee Documentation~     Committee Subjective Knee Form (IKDC), magnetic resonance imaging (MRI) to evaluate tendon~     regeneration of the hamstrings and finally kinetic/kinematic biomechanical outcomes of knee~     related functional tasks.~      To the investigators knowledge, this is the first RCT to investigate the efficacy of~     combined progressive resistance training and neuromuscular exercise in the late~     rehabilitation phase in patients demonstrating persistent limb-to-limb knee muscle asymmetry~     following ACLR. Reduced hamstring strength represents a potential risk factor for secondary~     ligament rupture and accelerated progression of osteoarthritis (OA). If deemed effective,~     the intervention paradigm introduced in this study may help to improve current treatment~     strategies.~   "
8981|NCT02939664|"~     This study try to identify differences in length of operation, weight loss and~     complications, between two different bariatric surgical techniques, the laparoscopic~     Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded gastric bypass. The study~     will be conducted in a Spanish public health system hospital. The patients of the trial will~     have the preoperative studies, hospital treatment during the admission, postoperative~     treatment and follow up as any other patient included in the hospital bariatric surgery~     program. The study cases will have placed around the gastric pouch a band of polypropylene~     mesh, and will be randomly choose between the participants.~      Patients will be randomized in a 5/3 (study/control) ratio.~   "
8982|NCT02939651|"~     The purpose of this research study is to test if pembrolizumab is safe and effective for~     treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum~     based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type~     of skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is~     not approved for treatment of metastatic high-grade neuroendocrine tumors.~   "
8983|NCT02939638|"~     This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based~     dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks,~     along with an untreated control for comparison, the study will measure changes in insulin~     sensitivity, postprandial metabolism, and intracellular lipid, and assess their associations~     with changes in body weight.~   "
8984|NCT02939625|"~     Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness~     and chronic airway inflammation and pharmacological treatment for this condition is done~     with bronchodilators and anti-inflammatory. Pharmacologic therapy has clinical efficacy in~     the control, but the patient often does not adhere adequately.~      There is need for further research into non-pharmacological therapies for clinical asthma~     control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial~     effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that~     these therapies also have effects on the BIE.~      The aim of this study is to evaluate the effect of these non-pharmacological therapies in~     several variables and especially the BIE.~   "
8985|NCT02939612|"~     The purpose with this study is to test the effect of an app for stress management among~     patients with different cancer diagnosis.~   "
8986|NCT02939599|"~     This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in~     adult patients with PAH. This study provides the patients who completed the QCC374X2201~     study with the option to continue receiving QCC374. The study will monitor the long-term~     safety, tolerability and efficacy of QCC374 in patients with PAH.~   "
9015|NCT02939222|"~     Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes.~     While the process of peri-implant disease is not well understood, implant position within~     the bony structure might play a role. However, there is no data available on this regard.~   "
9044|NCT02938845|"~     The purpose of this study was to identify factors that may contribute to anxiety of patients~     undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before~     and after the operation. Thus, we aimed to learn whether anxiety levels change according to~     the type of hysterectomy.~   "
8987|NCT02939586|"~     Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of~     haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor~     daytime function and increased risk of motor vehicle incidents.~      One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep~     apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few~     seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart~     attack and stroke, which are the leading causes of death in dialysis patients.~      In this project, the investigators will examine how a change of dialysis treatment might~     improve sleep. This project will first identify patients at risk of sleep disturbance using~     surveys and a subsequent sleep study. The investigators will then test different dialysis~     models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a~     dialysis model that works better for patients with sleep apnoea.~   "
8988|NCT02939573|"~     Multi-center sequential multiple assignment randomized trial comparing the effectiveness of~     three different standard of care treatment options for patients with isolated skin~     vasculitis.~   "
8989|NCT02939560|"~     The goal of this proposal is to investigate whether a standard rTMS protocol for depression,~     including multiple sessions applied to left dorsolateral prefrontal cortex (DLPFC) results~     in reduction of depressive symptoms for adult patients with ASD and MDD (Aim 1). The~     secondary goal is to investigate and whether there is any beneficial reduction in the core~     symptoms of autism (Aim 2).~   "
8990|NCT02939547|"~     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental~     treatment for people with Niemann Pick disease Type C (NPC-1) is safe at 2 different dose~     levels and what effects it has on people who have this condition. NPC-1 is caused by a~     defect in the protein which is important for the transport of fatty substances like~     cholesterol out of cells. Without this protein, fats build up in the cells ultimately~     leading to organ damage. The way in which this experimental treatment works is not fully~     understood but laboratory experiments have shown that it can potentially remove cholesterol~     build up from the cells in people who have NPC-1. Approximately 12 patients will be asked to~     take part in this research study for up to 20 weeks (w) in total (including screening.~     treatment and follow-up). Recruitment is expected to take 6- 9 months.Patients who take part~     will receive treatment by an intravenous infusion every two weeks. The study will look at~     what the body does to the drug as well as what the drug does to the body by taking and~     examining blood and urine samples. Samples of cerebrospinal fluid (CSF) will be taken by~     lumbar puncture during and following the first and subsequent treatment doses. Liver and~     skin biopsy specimens will be taken to assess filipin staining. Cholesterol metabolism will~     be investigated in liver samples and splenic and hepatic elasticity will be assessed by~     ultrasound..Patients will also have their hearing tested, be asked questions by their doctor~     as well completing questionnaires to help assess any changes in their condition during~     treatment.This study is being sponsored and funded by CTD holdings Inc. It is planned to be~     run in the USA,.~   "
8991|NCT02939534|"~     The way the immune system responds to certain PD-related proteins in PD donors compared to~     the way it responds in persons without or fewer PD related proteins is not well studied and~     this study aims to analyze the autoimmune response in each group. The study involves a one~     time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2~     tablespoons) to be collected.~   "
8992|NCT02939521|"~     A prospective design that studies the effects of a new technique for the treatment of pincer~     nails. The technique consists of a flattening of the bone of the distal phalanx with a~     frontal skin lifting that is performed in patients with a pincer nail deformity. Visual~     Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.~   "
8993|NCT02939508|"~     This prospective study was designed to compare the difference of effects of conventional~     treatment, medicine intervention, endoscopic therapy, and surgery between colon originated~     and non-colon originated ALGID in critical patients, in order to alert doctors to differ the~     treatment of the two ALGID and provide basis for treatment.~   "
8994|NCT02939495|"~     The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil~     30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile~     dysfunction.~   "
8995|NCT02939482|"~     The purpose of this study is to determine the effects of different rates of Caudal Epidural~     Steroid Injection (CESI) on clinical outcomes of the patients.~   "
8996|NCT02939469|"~     Since the invention of electrocardiogram (ECG), ECG has been an important part of clinical~     practice. A primary reason for the popularity of the ECG is that it is non-invasive and can~     be performed in any patient by placing electrodes on the skin. The present methods of ECG~     recording focus on detecting electrical signals from the heart. the investigators propose~     that with high frequency sampling and high pass filtering, the investigators can also record~     SNA from the skin. The somata of the subcutaneous sympathetic nerves on the skin are located~     at the ipsilateral cervical and stellate ganglia. Because the left stellate ganglion nerve~     activity (SGNA) is known to trigger cardiac arrhythmias, including AF, VF and VF, It is~     possible that skin SNA can also be used for arrhythmia prediction. the investigators tested~     that hypothesis in our preclinical studies (supported by R01 HL71140) using canine models.~     The results showed that subcutaneous nerve activity (SCNA) recorded with implanted~     electrodes can be used to estimate stellate ganglion nerve activity(SGNA) in normal dogs and~     in a canine model of ventricular arrhythmia and sudden death. the investigators also showed~     that SCNA is more accurate than heart rate variability in estimating cardiac sympathetic~     tone in ambulatory dogs with myocardial infarction.Therefore, SKNA and SCNA may be useful in~     estimating cardiac sympathetic tone. In addition to studying the autonomic mechanisms of~     cardiac arrhythmia, these new methods may have broad application in studying both cardiac~     and non-cardiac diseases. For example, sympathetic tone is important in the pathogenesis of~     heart failure, atherosclerosis, peripheral neuropathies, epilepsy, vasovagal syncope, renal~     failure, hypertension and many others diseases. Direct SKNA and SCNA recording may provide~     new approaches to study the mechanisms of these common diseases. SKNA recording may also~     have immediate clinical applications by assisting in the diagnosis and treatment of~     hyperhidrosis (sweaty palms), paralysis, stroke, diabetes, and neuromuscular diseases. It~     may be used to assist biofeedback monitoring performed by neurologists to control~     neuropsychiatric disorders. Because of these potential clinical and commercial applications,~     the investigators propose that this research project is significant.~      b. Innovation~        -  Using conventional electrodes on the skin to record SNA. The neuECG utilizes the~          conventional skin electrodes that are widely used in health care facilities. Skin SNA~          had been recorded using microneurography techniques, and had been estimated using~          cutaneous blood flow (vasodilator responses) skin temperature, skin conductance and~          sweat release. However, microneurography cannot be used in ambulatory patients. The~          other methods are not direct measurements of SNA. neuECG is the first method that can~          directly and non-invasively measure the SNA from the skin.~        -  Automated real-time signal processing. the investigators will develop signal processing~          software to automatically eliminate noise, such as that generated by muscle~          contraction, electrical appliances, body motion, respiration, and radiofrequency~          signals. The remaining signals are then processed to separately display in real time to~          provide health care providers a new method to instantly estimate sympathetic tone. The~          ECG signals are used for automated arrhythmia detection while the SNA signals are~          available for risk stratification. This approach allows us to improve and broaden the~          clinical application of Einthoven's original invention by simultaneous detecting ECG~          and SNA from the skin.~        -  SKNA patterns as new biomarkers. the investigators have identified unique SKNA patterns~          that precede the onset of human AF. If proven correct by Specific Aim 3, this new~          biomarker can help physicians to estimate the arrhythmia risk and to predict the~          efficacy of catheter ablation for AF.~   "
8997|NCT02939456|"~     This is a pilot study taking place at University Hospitals of North Midlands NHS Trust.~     Patients referred for MRI for possible prostate cancer will be invited to take part in the~     study. Following consent, participants will have an additional MRI sequence performed during~     their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).~      Participants scan images and prostate biopsy histology report (if applicable) will be~     reviewed by the research team.~   "
8998|NCT02939443|"~     Background: The aim of this study was to investigate the efficacy of prone-position computed~     tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT~     before laparoscopic inguinal hernia repair.~      Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal~     preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients~     diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine~     and prone positions for preoperative assessment. The anatomy of the right and left inguinal~     regions was confirmed during the surgery and compared with the preoperative CT findings.~   "
8999|NCT02939430|"~     Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation.~     benefits of reversal of neuromuscular blockade appears to be of great value in living donor~     liver transplant recipients. However, Few Clinical reports have investigated the~     anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile~     of living donor liver transplantation will be investigated.~   "
9000|NCT02939417|"~     The aim of this study is to evaluate the clinical performance of E-max veneers cemented with~     and without using grape seed extract before bonding.~   "
9224|NCT02936479|"~     This is an open-label, single arm trial in which patient who have ongoing antibody mediated~     rejection of a kidney transplant deemed refractory to maximal medical therapy are given the~     complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing~     antibody mediated injury. A maximum of 5 patients will be enrolled.~   "
9001|NCT02939404|"~     One reason people gain weight is eating more calories from food than what they need for~     energy over 24 hours. Metabolism is the amount of energy a person uses over 24 hours.~     Researchers want to study the relationship between changes in metabolism and how much a~     person eats.~      Objectives:~      To see how much food a person eats when the body s temperature is cooled. To study how~     changes in metabolism may alter the amount of food a person eats.~      Eligibility:~      Healthy people ages 18-55.~      Design:~      Participants will stay at NIH for 20 days.~      During the first 4 days, participants will have:~        -  Medical exam~        -  Electrocardiogram~        -  Blood and urine tests. One blood test includes drinking a sugar solution.~        -  DXA body composition scan~        -  Questions about foods they like, physical activity, and personal behavior~        -  Exercise test on a stationary bicycle~      Participants will spend 24-hour periods in a metabolic chamber. The chamber will be at~     normal room temperature or cooler.~      Some times, participants will eat a diet that matches their daily needs. Other times, they~     can eat as much as they wish from a vending machine.~      Participants will have blood and urine collected.~      Participants will swallow an ingestible wireless sensor and wear a small data recorder~     device.~      On the second to last day, participants will stay in the metabolic chamber but only consume~     water and non-caffeinated sugar-free beverages.~      Participants will come back for 1-day visits at six months and one year from the first~     admission. They will have blood and urine tests, and a DXA scan. They will answer questions~     on physical activity and food habits.~   "
9002|NCT02939391|"~     The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's~     disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score~     between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.~   "
9003|NCT02939378|"~     Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in~     vitro.~      Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic~     adjuvant to salvage chemotherapy for recurrent glioblastoma.~   "
9004|NCT02939365|"~     The purpose of this study is to determine the safety and feasibility of converting patients~     to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what~     percentage of those patients can be safely converted to once every 8 week administration of~     Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for~     kidney transplant recipients.~   "
9005|NCT02939352|"~     High relapse rates among substance dependent individuals are likely due to a combination of~     factors that involve limbic circuits in the brain involved in craving, including~     vulnerability to salient cues. Emerging data suggests that non-invasive, targeted brain~     stimulation may be able to modulate activity in these circuits and decrease craving. The~     primary goal of this pilot study is to determine the extent to which a single session of~     continuous theta burst stimulation (TBS) to the medial prefrontal cortex can attenuate~     limbic circuitry involved in craving among cocaine users and alcohol users. This will be~     tested through a double-blind,sham-controlled brain stimulation and brain imaging study in a~     cohort of polysubstance abusers and alcohol users.~   "
9006|NCT02939339|"~     The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an~     effective treatment in decreasing craving in individuals who habitually smoke cigarettes.~     The study consists of six total visits to MUSC; one for the consent process, two that will~     include MRI scans, and five that will include TMS administration. Compensation will be~     provided for each visit.~   "
9007|NCT02939326|"~     To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar~     frown lines (GL).~   "
9008|NCT02939313|"~     The goal of this investigation is to determine if, in heavy alcohol users, a single session~     of transcranial magnetic brain stimulation (TMS) over a brain region involved in craving~     (medial prefrontal cortex) and a brain region involved in cogntive control (dorsolateral~     prefrontal cortex) can lower an individual's craving and brain response to alcohol cues.~     This study involves a screening visit, followed by three visits which involve brain imaging~     (using functional MRI) and brain stimulation (using TMS). There is also an additional~     Magnetic resonance spectroscopy (MRS) exploratory Aim in which we will measure the~     concentration of glutamate in the prefrontal cortex before and after a session of TMS.~   "
9009|NCT02939300|"~     This research study is studying a combination of two drugs as a possible treatment for~     Leptomeningeal Metastases from Melanoma.~      The names of the study interventions involved in this study are:~        -  Ipilimumab~        -  Nivolumab~   "
9010|NCT02939287|"~     The purpose of this study is to help answer the following research question:~        -  Whether administration of an aprepitant containing regimen or an olanzapine containing~          regimen will prevent nausea and vomiting better for patients undergoing an autologous~          stem cell transplant with melphalan chemotherapy. Both of these medications are~          approved by the United States Food and Drug Administration (FDA) for nausea and~          vomiting.~        -  Participants will be randomly assigned to one of the 2 treatment groups:~             -  Arm A: aprepitant plus standard anti-emetic regimen~             -  Arm B: olanzapine plus standard anti-emetic regimen~   "
9011|NCT02939274|"~     The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low-~     Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of~     cutaneous metastases of breast cancer for which no curative or significantly palliative~     therapy exists, including chest wall therapy.~   "
9012|NCT02939261|"~     The overall objective of this research is to test, among families with children age 2-5~     years, the immediate and longer-term impacts of a home-based intervention to improve~     household routines associated with reduced obesity risk. The investigators primary~     hypothesis is that, compared to control, children in the intervention group will have lower~     BMI following the 6-month intervention period and 18-month follow-up period. The secondary~     outcomes are change in children's % body fat, waist circumference and obesity-related~     behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although~     child outcomes are the focus of this evaluation, changing household routines may also~     improve parent behaviour; thus, the investigators will assess change in parent behaviours~     and weight outcomes. This study will also assess the cost-effectiveness of the intervention~     from a societal perspective.~   "
13259|NCT02883699|"~     The TOP Study is a two-stage study on individually tailored endurance and resistance~     training prescriptions for breast and prostate cancer patients after the end of primary~     therapy in order to optimize training effects.~   "
9016|NCT02939209|"~     Arthroscopic shoulder rotator cuff repair is associated with severe postoperative pain. The~     interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by~     anesthetizing the nerves that supply the shoulder. Although the nerve block provides~     extremely effective analgesia for the first 6-8 hours, patients experience severe pain once~     its effect has regressed. This study will assess whether a single dose of oral hydromorphone~     controlled release (CR), given to overlap the waning of the ISB, will improve postoperative~     pain control and reduce the incidence of rebound pain.~      Seventy patients undergoing rotator cuff repair will receive standardized ISB and general~     anesthesia for the surgery. Six hours after ISB, the patients will randomly receive either a~     single oral dose of 2 mg Hydromorphone (immediate release formulation) or placebo. The~     patient will be then discharged home with a prescription for multimodal analgesia, which is~     the standard of care. Patients will be given a diary to record their pain scores and track~     use of analgesic medications for 24 hours. Twenty-four hours after the ISB, the patients~     will receive a phone call from a nurse as per the standard of care. During this phone call,~     questions will be asked about their pain control.~      If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it~     will lead to change in practice of how we manage pain after rotator cuff repair.~     Furthermore, the finding of this study may apply to similar surgical procedures (such as~     elbow, knee and ankle repairs) that are associated with rebound pain when the nerve block~     wears off.~   "
9017|NCT02939196|"~     The purpose of the investigators'study was To compare 2 different diameter rigid~     hysteroscopy in vaginoscopic approach regarding pain during and after the procedure.~      And to evaluate patient acceptability and tolerability in order to determine the best way to~     perform hysteroscopy in an outpatient setting.~   "
9018|NCT02939183|"~     A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in~     patients with relapsed refractory multiple myeloma.~   "
9019|NCT02939170|"~     The purpose of this study is to evaluate the impact of back surface molded marks (MM)~     applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort~     device related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded~     marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).~   "
9020|NCT02939157|"~     Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in~     primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan~     P10) performed at a specialized the eco.lab, as reference.~   "
9021|NCT02939144|"~     Aldosterone, the major mineralocorticoid hormone and cortisol, the major glucocorticoid~     hormone are produced in the adrenal gland. Aldosterone binds intracellular mineralocorticoid~     receptors (MR) in the kidney promoting urinary reabsorption of sodium and water and~     excretion of potassium and hydrogen ions. Unregulated mineralocorticoid excess may,~     therefore, lead to high blood pressure due to sodium and water retention and hypokalaemic~     alkalosis.~      Blood concentrations of cortisol which has equal affinity for MR are 1000fold greater than~     those of aldosterone. Therefore in order not to overwhelm MR, cortisol needs to be~     inactivated before it binds MR. This is achieved by the enzyme 11-betahydroxysteroid~     dehydrogenase type 2 (11ßHSD-2) in the kidney which rapidly inactivates cortisol to~     cortisone (this process allows only aldosterone to bind MR). Reduced activity of 11ßHSD-2~     leads to an accumulation of cortisol which binds MR and hence has the effect of aldosterone.~     Reduced activity of 11ßHSD-2 may be seen in the inherited condition of 'Apparent~     mineralocorticoid excess (AME)' or in excessive liquorice ingestion. The diagnosis of AME~     and liquorice toxicity is difficult due to unavailability of diagnostic urine analysis in~     most general laboratories. Cortisol in the salivary glands, similarly to that in kidneys, is~     metabolised by 11β-HSD2 to cortisone. It is proposed that increased salivary~     cortisol/cortisone ratio could offer a simple and convenient diagnostic test for AME and~     liquorice toxicity and can be used as a surrogate marker of urinary cortisol/cortisone~     ratio. The advantages of salivary cortisol/cortisone include non-invasiveness making it~     stress free for the patient, no risk of needle stick injury and ease of collection allowing~     potential home testing and posting of samples.~   "
9022|NCT02939131|"~     IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate~     whether a health and wellness Cognitive Behavioral Therapy and Medication Management~     (COMB-R) intervention for depression demonstrates improved depression and medical outcomes~     for HIV-infected youth in the US compared to enhanced standard care (ESC).~   "
9023|NCT02939118|"~     The purpose of this trial is to evaluate the long-term safety in subjects previously~     implanted with VC-01™ combination product.~   "
9024|NCT02939105|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum~     applicators for non-invasive subcutaneous fat reduction of the upper arms.~   "
9025|NCT02939092|"~     To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and~     chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a~     group of Egyptian children with permanent dentition.~   "
9026|NCT02939079|"~     This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in~     patients with Relapsing-Remitting Multiple Sclerosis.~   "
9027|NCT02939066|"~     Current modalities for lymph node staging in cancer can be limited. Needle-based confocal~     laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the~     19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time~     in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to~     evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of~     endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between~     benign and malignant lymph nodes.~   "
9028|NCT02939053|"~     This study aims to establish the degree to which change in the ratio of ECF to TBW measured~     using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP~     measured using the CardioMEMS HF System (St. Jude Medical).~   "
9041|NCT02938884|"~     The primary objective of this study would be to determine whether utilization of this~     technology improves adherence to recommended increases in hydration for stone forming~     patients with low urine volume relative to standard techniques such as education and reading~     materials. We hypothesize that the addition and utilization of the smart water bottle to~     standard recommendations will lead to measurable increases 24 hour urine output for affected~     patients.~   "
9029|NCT02939040|"~     This study is to assess the feasibility of using a positive activities intervention,~     Positive Piggy Bank, in newly diagnosed women with breast cancer who will soon undergo~     surgery. A randomized controlled pilot trial of a brief self-guided positive activities~     intervention, The Positive Piggy Bank (PPB), compared to Treatment as Usual. The PPB~     intervention involves noting at least one positive event each day, writing it down on a slip~     of paper and then depositing this piece of paper in a piggy bank. This practice is to take~     place at the end of the day, every day over a circumscribed period of time. At the end of~     the deposit period, in the case of this study after approximately 21 days, the participant~     closes the account and makes a full withdrawal by taking all of the slips out of the piggy~     bank and reading each one on the night before surgery.~   "
9030|NCT02939027|"~     Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the~     treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the~     treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for~     the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be~     the best treatment option. Location of the tumour in cosmetically sensitive areas, patient~     comorbidities, old age, use of anti-coagulation etc. might all be reasons to select~     radiotherapy as first choice of treatment. The objective of ths study will be to determine~     histologically confirmed clinical efficacy, safety, and usability of Electronic~     Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).~   "
9031|NCT02939014|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of~     brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+~     Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).~   "
9032|NCT02939001|"~     This study included patients who visit for refractive surgery (photorefractive keratectomy,~     photorefractive keratectomy with with corneal collagen cross linking, laser in situ~     keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation~     (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined~     whether iris recognition scanner of smartphone works before and after surgery. In addition,~     before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris~     recognition scanner of smartphone works well.~   "
9033|NCT02938988|"~     The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic~     therapy as an adjuvant of scaling and root planning for treatment of periodontal disease in~     patients with Down's Syndrome. After scaling and root planning, half of patients received~     antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were~     repeated after 3, 7 and 14 days. The other half received only scaling and root planning.~   "
9034|NCT02938975|"~     Purpose~      While there is strong evidence that permethrin treated clothing prevents insect bites there~     is insufficient evidence from trials to demonstrate a reduction in infections. The evidence~     that topical insect repellants prevent malaria is more robust, but studies in civilian~     suffer from poor compliance. It is not known if there is an added benefit from combining the~     two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are~     compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga~     region.~      The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU)~     and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group~     receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat~     uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and~     placebo lotion. Both participants and investigators will be blinded to treatment allocation.~      The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by~     Polymerase Chain Reaction every month by active case detection.~   "
9035|NCT02938962|"~     The objective of this study is to evaluate and compare the effects of intravenous and~     topical administration of tranexamic acid during revision hip arthroplasty on blood loss,~     allogenic blood transfusion rates, length of hospital stay and perioperative complications.~   "
9036|NCT02938949|"~     Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an~     inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to~     high-intensity statin (atorvastatin 80 mg) in lowering low density lipoprotein (LDL)~     cholesterol during non-ST segment elevation myocardial infarction (NSTEMI).~   "
9037|NCT02938936|"~     Our study's principle purpose is to determine whether decreasing waiting time before being~     seen for antenatal care increases demand for and use of antenatal care services in~     Mozambique.~   "
9038|NCT02938923|"~     This study is a randomized, controlled multi-center clinical trial comparing the effects of~     six months of testosterone replacement therapy, with and without supervised exercise~     training, in frail elderly female hip fracture patients. One third of the participants will~     receive topical testosterone therapy and a supervised exercise training program; one third~     will receive topical placebo gel and a supervised exercise training program; one third will~     receive topical placebo gel and a home exercise program.~   "
9039|NCT02938910|"~     Animal models have demonstrated the role of aldosterone in left ventricular remodeling~     involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for~     serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease.~     It is accepted that patients with primary aldosteronism have a higher prevalence of LV~     hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has~     been demonstrated between aldosterone and heart failure as well as the benefit of the~     administration of an anti -aldosterone drug to lower mortality in this population ,~     regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in~     hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in~     humans has been associated with inflammation, fibrosis and aortic stiffness . However,~     primary aldosteronism is generally associated with so-called secondary hypertension .~     Chronic hypertension alone is a recognized etiological factor of myocardial hypertrophy (~     myocardial fibrosis very advanced ) . The purpose of this study is to investigate the~     effects of MRI hyperaldosteronism on the heart.~   "
9040|NCT02938897|"~     This study is a 12-week pilot randomized controlled trial to test the feasibility and~     effectiveness of a home telenutrition weight loss program in men in West Virginia.~   "
47186|NCT02439411|"~     The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in~     overall survival, response rates and toxicity in both programs.~   "
9045|NCT02938832|"~     This is a multi-centre, open, randomised study in patients treated for ischemic heart~     disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients~     who are treated at the cardiac rehabilitation units will be consecutively recruited during~     three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean~     diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional~     low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they~     want to participate and provided with written information about the study when they are~     discharged from the hospital after treatment for ischemic heart disease. The decision to~     participate or not will be given at the following outpatient treatment at the cardiac~     rehabilitation unit. When the signed informed consent to participate in the study has been~     provided, the patient will be randomised to advice of either of the two dietary regimes.~   "
9046|NCT02938819|"~     Upper-limb disorders in patients with Parkinson's disease include decreased speed and~     amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine~     manipulative hand activities.The aim of the study was to evaluate the effects of home-based~     goal-oriented upper limb intervention in patients with Parkinson's disease.~   "
9047|NCT02938806|"~     This study employs a cross-sectional design to profile the gut microbiome and urine~     metabolome in overweight/obese children with type 1 diabetes (T1D).~   "
9048|NCT02938793|"~     This is an investigator initiated single institution, open-label study to evaluate the~     antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab~     in subjects with select advanced rare solid tumors.~   "
9049|NCT02938780|"~     Preventing or reducing obesity is one factor that has been hailed as a way to improve~     quality of life, reduce recurrence, and increase survival rates among breast cancer~     survivors. An experienced team of multi-disciplinary researchers has developed an innovative~     and unique approach to encourage enhanced nutrition and exercise behaviors in this~     population using principles of behavioral economics. In particular, the use of social norms~     or exemplars has been shown in other applications to be effective, and if successful in this~     population could be inexpensively scaled up for widespread adoption. The proposed pilot~     study develops a system of text messages for social/mobile media that will provide ongoing~     reinforcement of desired behavior in breast cancer survivors. These messages would focus on~     achieving compliance with the expert-developed nutrition and exercise recommendations of the~     American Cancer Society. In the main study, 310 breast cancer survivors will be randomly~     placed in intervention and control groups for the 12 week study. Behavior change will be~     measured using established measures of self-reported behavior. In a sub-study, 60 of the~     breast cancer survivor participants will also provide blood and urine samples so changes in~     biomarkers can be assessed. The impact of the study will be measured by biomarkers and~     self-reported survey responses.~   "
9050|NCT02938767|"~     Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of~     this study is the long-term prognostic values of carotid intima-media thickness and coronary~     flow reserve in cardiovascular mortality of peritoneal dialysis patients.~   "
9051|NCT02938754|"~     In this study the investigators evaluate the effectivity of Virtual Reality-based~     rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.~   "
9052|NCT02938741|"~     ATG based conditioning regimen in HLA related allogeneic hematopoietic stem cell~     transplantation for aggressive T-cell tumors: multi-center, open, randomized controlled~     clinical study~   "
9053|NCT02938728|"~     Melanoma is the most aggressive skin cancer. Major advances in metastatic melanoma treatment~     emerge from new immunotherapies that target specific immune inhibitory checkpoint receptors,~     mainly PD1 and CTLA-4, and overcome the exhaustion state of T cells. In this context,~     checkpoint inhibitors, such as Ipilimumab (anti-CTLA-4 monoclonal antibodies, mAb) and~     Nivolumab or Pembrolizumab (anti-PD1 mAb), have demonstrated survival benefit in advanced~     melanoma patients. Anti-PD1 agents and combination of anti-PD1 and anti CTLA-4 have now been~     approved as first line therapy in melanoma. However, the predictive factors of response to~     these immunotherapies remain so far elusive. Recent studies provided consistent evidence~     that the immune infiltration could be tested as a biomarker for such immunotherapies.~     Moreover, the very recent concept of tumor neoantigens as biomarkers of response to~     anti-CTLA-4 mAb, and potentially also to anti-PD1 or combination therapies, is promising but~     needs to be further explored.~      In this context, the aim of our program is to identify and validate an immune signature~     predictive of anti-PD-1 benefit in the treatment of advanced melanoma patients. To this aim,~     tumor samples from 120 melanoma patients enrolled prospectively, treated with anti-PD1 mAb~     alone or combined with anti CTLA4, will be collected as well as the corresponding peripheral~     blood mononuclear cells (PBMC). Tumor infiltration with immune cells will be characterized~     on paraffin embedded melanoma samples. The investigators will also perform whole-exome~     sequencing on tumors and matched PBMC samples. Our primary objective is to develop a~     combined immuno-signature based on an immuno-score (CD3, CD8, CD45RO…) to quantify the in~     situ immune populations with a dedicated image analysis system combined with the~     simultaneous detection of CD8-PD-1 and PD-L1 by immunofluorescence in baseline tumor~     samples. This will permit to predict 1-year survival of patients with advanced melanoma~     treated with anti-PD1 and transfer in patient's care.~      Our secondary objectives are: 1/ To assess the interest of the detection of tissue-resident~     memory (TRM) T cells (CD8-CD103) as a predictive biomarker of response and survival at~     1-year; 2/ To extend the panel of neoantigens published by Snyder et al to other neoantigens~     using a next-generation sequencing (NGS) approach on tumor samples obtained before therapy;~     3/ To establish the prognostic value of this panel of neoantigens to predict tumor response~     to anti-PD1 and 1-year survival; 4/ To functionally validate the identified tumor~     neoantigens by stimulating patient PBMC with neoantigen peptides and measuring~     tumor-specific T-cell reactivity; 5/ To define the best marker and/or the best combination~     of markers predicting the overall response rate and the survival at 12 and 18 months; 6/ To~     attempt to establish a correlation between immuno-signature and neoepitopes and 7/ To~     transfer this immune signature in routine basis if validated.~      Thus, our project will integrate two complementary strategies to define a robust and~     reliable score system for predicting anti-PD1 targeting immunotherapy response. This study~     will provide a unique opportunity to validate various putative biomarkers in an integrated~     way that could help in determining the respective value of each isolated parameter and~     potentially lead to the definition of a composite biomarker. The identified immune signature~     would be of major interest in the field of cancer immunotherapy in order to select and~     manage patient treatment, and to consider the benefice or toxicities expected. It will also~     help to identify new target antigens of effective antitumoral immune responses and to~     understand the resistance mechanisms established by the tumor and its influence on the~     response to current immunotherapies.~   "
9054|NCT02938715|"~     In this study, we will recruit subjects who are attending the dermatology clinic and who~     have already been prescribed topical 5-fluorouracial for the treatment of actinic keratoses~     as part of their standard of care. The purpose of the study is to assess patient~     satisfaction when engaging in follow up treatment of actinic keratosis via the~     HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess~     the difference in total duration of treatment between treatment and control group. We expect~     to enroll 50 subjects and they will be randomly assigned into the treatment group~     (teledermatology group; n=25) or control group (telephone only group; n=25).~   "
9055|NCT02938702|"~     The study is a multi-center prospective cohort study of active surveillance in papillary~     thyroid cancer with low risk. The purpose of the study is to observe natural course of low~     risk papillary thyroid cancer in Korean population, and comparison of prognosis between~     active surveillance group and conventional surgery group. Patient will be well informed~     about their choice of active surveillance or surgery.~   "
9056|NCT02938689|"~     This study is to compare the efficacy of exercises based on the lumbar extension and flexion~     on the pain relief and the prevention of pain recurrence in chronic low back pain patients.~   "
9057|NCT02938676|"~     Any member of the research team conducted screening for the selection of eligible patients.~     Nurses will be responsible for delivering the Guide tips for the person with a transplanted~     heart, thus initiating an individualized education program. Education will be held at the~     time of admission in which the patient has passed the most critical post-operative.~      Educational tips guide contains all the information necessary for the patient to have a~     first contact on the habits that must change. Education lasts 10-30 minutes and is taught in~     daytime, in a calm environment and at the right time, favoring the presence of the~     caregiver. Later, education is reinforced on the doubts that arise both the patient and the~     primary caregiver.~      During the first days of admission to the unit of cardiology, socio-demographic data of the~     patient and primary caregiver by the research team will be collected.~      A few days before discharge, having left time between 7-8 days after delivery of educational~     advice guide, any member of the research team, who does not work in the cardiology unit,~     will provide the patient and the primary caregiver the satisfaction questionnaire where the~     perception of information and education received during the postoperative period in the~     inpatient cardiology unit and the appropriateness of the topics covered in the guide~     educational advice.~   "
9140|NCT02937571|"~     The purpose of this study is to test whether giving high doses of carfilzomib along with the~     other drugs (lenalidomide and dexamethasone) is safe and which dose is best tolerated by~     patients. In addition, the study is designed to test the amount of remaining myeloma cells~     in the body after treatment with higher carfilzomib doses which is known as minimal residual~     disease (MRD).~   "
9058|NCT02938663|"~     The overall goal of this study is to examine the relationships between cultural identity and~     identity-based motivation, physical activity, diet and obesity risk in African-American~     adolescents. It was hypothesized that African-American youth who self-report a bicultural~     identity maintain health promotion beliefs and behaviors that reduce obesity risk compared~     to minority youth who only identify with one culture or neither culture. It was also~     hypothesized that African-American youth who self report a bicultural identity are more~     likely to hold beliefs about health promotion behaviors that are congruent with their~     cultural identity than compared to youth who only identify with one culture or neither~     culture.~   "
9059|NCT02938650|"~     We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids~     and inflammatory cytokines on the skin.~   "
9060|NCT02938624|"~     A single arm, phase I, dose escalation trial and expansion cohort, examining the safety and~     feasibility of neoadjuvant pembrolizumab treatment for early resectable NSCLC patients.~      Hypothesis: The investigators hypothesize that response rate to neo-adjuvant pembrolizumab~     will be higher than the response rate of advanced NSCLC patients.~   "
9061|NCT02938611|"~     The main objective of this study is to evaluate the feasibility of estimating the prevalence~     of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained~     via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory~     tests is adapted to nephrology care delivery, as recommended by the French High Authority of~     Health (HAS), laboratory data will be compared with those of patients seen by nephrologists~     in the department.~   "
9062|NCT02938598|"~     Mothers with symptoms suggesting clinical depression can be identified and potentially~     motivated to seek further care during pediatric visits for their young children. The best~     ways for pediatric providers to encourage mothers to seek further evaluation and treatment~     for their depressive symptoms are not known. The investigators plan to provisionally~     optimize a pediatric office-based intervention that we developed to motivate mothers who may~     be depressed to seek further care and, thereby to improve the well-being of women from~     diverse backgrounds and their children.~   "
9063|NCT02938585|"~     This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy~     of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe~     haemophilia A (FVIII≤1%).~   "
9064|NCT02938572|"~     Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of~     NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus~   "
9065|NCT02938559|"~     The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether~     the Memory Support Intervention improves illness course and functional outcomes in major~     depressive disorder (MDD) and cognitive therapy (CT).~   "
9066|NCT02938546|"~     The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism~     after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the~     role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical~     trial platform of molecular classification and molecular imaging for cancer chemotherapy~     assessment.~   "
9067|NCT02938533|"~     Interventions incorporating constructs from behavioral economics and psychology have the~     potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this~     hypothesis, the investigators evaluated a combination intervention to improve antiretroviral~     therapy (ART) adherence based on the concepts of social norms and priming.~   "
9068|NCT02938520|"~     The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if~     human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is~     virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will~     remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen~     of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized,~     open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1,~     anti-retroviral therapy (ART)-naïve adult participants. This study is designed to~     demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg +~     RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over~     48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701~     positive at Screening may enroll into the study and receive DTG plus a non-abacavir~     containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible~     particpants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20~     weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50~     copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance~     Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral~     therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly~     CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. At the~     end of the Maintenance phase, eligible participants who were randomized to continue~     ABC/DTG/3TC will be given an option to switch to LA therapy at Week 100. Those participants~     (HIV 1 RNA <50 c/mL at Week 96) will transition to LA dosing, beginning with approximately 4~     weeks oral CAB + RPV therapy at Week 100, and receive the first IM CAB LA + RPV LA~     injections at Week 104b. Participants will continue to receive injections every 4 weeks~     during the Extension Phase until CAB LA and RPV LA are either locally approved and~     commercially available, the participant no longer derives clinical benefit, the participant~     meets a protocol-defined reason for discontinuation, or until development of either CAB LA~     or RPV LA is terminated.~   "
9069|NCT02938507|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     different formulations of orally administered solabegron in healthy male subjects.~   "
9070|NCT02938494|"~     Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment~     of Acne Vulgaris~   "
9071|NCT02938481|"~     The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution~     in colon cancer and provide reliable evidence regarding the optimal length of bowel~     resection and the extent of central lymph node dissection in colon cancer surgery.~   "
9137|NCT02937610|"~     PEG tubes are commonly used to provide nutritional support to patients with head and neck~     cancer. PEG insertions are typically carried out by gastroenterologists, but also~     otorhinolaryngologist - head and neck surgeons perform the procedure in some countries.~     Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The~     investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG~     tube insertions, and analyze the time gains and cost effectiveness achieved of the~     independency from other specialities.~   "
9141|NCT02937558|"~     This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with~     open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a~     continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose~     infusion rates in children < 1 year of age with congenital hyperinsulinism.~   "
13526|NCT02879188|"~     The purpose of this study is to determine the impact of the timing of physical therapy (PT)~     initiation on postoperative length of stay and the time to physical therapy clearance~     following total knee replacement.~   "
9072|NCT02938468|"~     Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the~     subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH~     is believed to arise from tearing of bridging veins as a result of trauma, which may be~     minor and unapparent to the patient. Management of cSDH is widely varied. A wait-and-see~     or wait-and-rescan approach may be acceptable in asymptomatic patients with a relatively~     small hematoma whilst cSDH with severe neurological deficits or decreased level of~     consciousness may require surgical decompression by burr-hole craniostomy, twist drill~     craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up~     to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The~     safety and efficacy of different neurosurgical procedures have been evaluated but there is a~     paucity of well-designed randomized controlled trials in the literature. Consequently, there~     is no consensus on the best treatment with respect to surgical technique, pre-operative and~     post-operative management and nonsurgical alternatives including the use of Corticosteroids,~     Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE)~     inhibitors.~      Corticosteroids may be a therapeutic option in the management of cSDH. There is very little~     data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized~     trials. The purpose of the study is to prove dexamethasone can be just as efficacious as~     surgery in treating chronic subdural hematoma. The investigators also hope to show that~     those patients treated with dexamethasone suffer less complication compared to those who~     undergo surgery.~   "
9073|NCT02938455|"~     In the last few years much attention has been paid to hyperalgesia induced by opioids, which~     represents a clinically significant condition following acute and chronic exposure to~     opioids. It has been suggested that the increase in gene expression of μ-opioid receptors~     and the development of hyperalgesia could be linked to epigenetic mechanisms. In particular~     the use of opioids seems to be related to an increase of the degree of DNA methylation. In~     the literature are not currently available data about the degree of DNA methylation in~     surgical patients, opioid-naive prior to surgery, receiving acute opioids treatment in the~     perioperative period.~      The primary objective of this study is to assess the degree of perioperative DNA methylation~     (extracted from whole blood) in patients undergoing major surgery exposed to opioids~     according to current clinical practice compared to preoperative baseline levels. The timing~     (preoperative vs intraoperative vs postoperative) in which the possible increase of the~     degree of DNA methylation will happen wil be assessed.~      20 consecutive patients undergoing major surgery performed under general anesthesia that~     have expressed their consent to participate to the study will be enrolled. This sample is~     adequate to allow the observation of a possible increase of DNA methylation in opioid-naive~     patients exposed to anesthesia/analgesia based on opiates according to current clinical~     practice.~   "
9074|NCT02938442|"~     The purpose of this research is to compare the effect on breast cancer of using a new~     experimental breast cancer vaccine (used to stimulate immune cell production) with~     chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.~   "
9075|NCT02938429|"~     This study will be a cross sectional assessment of physical activity as measured through~     accelerometers and its association with endothelial function of children with Fontan~     circulation who are followed at the University of Alberta - Stollery Children's hospital.~   "
9076|NCT02938416|"~     Our participants will include 40 patients within one month of stroke, 40 patients who~     received total hip replacement or total knee replacement two to four weeks before. The~     participants will be randomly assigned to the isokinetic training group or the isotonic~     training group. Outcome measures including isometric peak torque of hip/knee at 90 degree of~     flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short~     Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma~     concentration of hsCRP, and the level of substance P in saliva will be collected at the~     beginning and 4 weeks after the training program. Statistical significant differences will~     be determined between the improvement of outcome measures of the isokinetic and the isotonic~     training groups.~   "
9077|NCT02938403|"~     This is a study to determine the efficacy of a smoking cessation intervention (nicotine~     replacement therapy (NRT) and counseling) done in a systematized manner with participants~     recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use~     of the NRT medication during the session using specialized counseling focused around their~     experience of using NRT, including how the use of NRT may help them quit smoking, side~     effects, and smoking cessation expectancies. In this study those in the In Vivo group will~     put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the~     experience of wearing the patch or chewing the gum while they are in session. The control~     group will not put on the patch or chew gum during the sessions but will be given standard~     counseling regarding quitting smoking.~   "
9078|NCT02938390|"~     Approximately 100 women scheduled for NSM will be consented pre-operatively to participate~     in the study. US will be performed after induction of general anesthesia, prior to surgery~     using Sonosite™ portable US, 5-12mHz transducer using doppler mode.~   "
9079|NCT02938377|"~     Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and~     alcohol use Disorders (AUD) symptoms.~      Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and~     HIV-related outcomes.~      Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions~   "
9080|NCT02938364|"~     The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques:~     the ear plug technique and acupressure on the P6 point in reducing gag reflex during~     impression making and to assess patient's experience in terms of comfort and satisfaction.~   "
9081|NCT02938351|"~     The aims of the present study will be to pilot test the efficacy of a collaborative care~     intervention in patients treated with dialysis to reduce symptoms of depression, pain,~     sleep, fatigue and improve quality of life.~   "
9082|NCT02938338|"~     The aim is~      to examine the energy consumption before and after bariatric surgery. The study will~     contribute to the knowledge if operations should be complemented by interventions to~     increase energy expenditure, mainly by reducing sedentary.~      as input for the design of an intervention to reduce sedentary. Such intervention should be~     based on knowledge of the mediators of physical activity among the subjects that need to be~     strengthened.~   "
9083|NCT02938325|"~     General anesthesia (GA) is the process of induction of unconsciousness in order to undergo~     surgery. Unlike sleep, a process of anesthesia is not related at all, 'Sleep' and does not~     include dreams - but is done by using drugs that cause a kind of unconsciousness control.~      The induction of GA includes combination of drugs - for sleep (inhalation anesthesia or~     hypnotic drugs intravenously), analgesia (opiates) and muscle relaxants. Since most of our~     patients paralyzed during surgery, the anesthesiologists have no way of knowing whether our~     paralyzed patient is asleep or awake. If the patient is awake and paralyzed, a situation~     named awareness under anesthesia it can cause him a traumatic experience that would leave~     him a cripple for his whole life.~      There are many stories about patients who lay paralyzed, awake, while been operated, who~     remembered every word of what happened during the operation and of course could not mark the~     anesthetist that they are awake. The anesthesiologist might suspect that his patient is~     awake and paralyzed through signals from the sympathetic nervous system - for example the~     increase in heart rate and blood pressure. But many of our patients receive different~     medications (eg, beta-receptor blockers that does not allow the rise of a pulse) obscuring~     the clinical signs, so that the patient is awake and paralyzed without being noticed by the~     anesthesiologist.~      Some patients are at a higher risk to suffer from awareness under anesthesia, because the~     anesthesiologist cannot provide enough anesthesia, due to their medical condition, for~     example: women in caesarean section under GA, patients in cardiac surgery or injured trauma~     patients.~      Twenty years ago, an EEG based tool, naming BIS was developed. Nowadays, BIS monitor's~     credibility is questionable 1. The effect of different hypnotic drugs is not uniform. 2.~     Recently it was shown that a paralyzed patient BIS index could fall mimicking a situation of~     a sleep - enabling a paralyzed patient being awake. Thus, it is not clear whether the~     calculation of the BIS monitor is based on physiological models that define what is~     consciousness, loss of consciousness and how consciousness arises. It seems that the BIS is~     only suitable for certain drugs - not as a general monitor for the level of anesthesia.~      The purpose of the present study is to develop a universal system for determining awareness~     under GA using an innovative algorithm for analyzing EEG waves, based on the physiological~     processes of attention and perception underlying the basis for sedation and GA.~   "
9084|NCT02938312|"~     This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state).~     Approximately 400 overweight or obese African American women living in the selected counties~     will participate in a 2-year weight loss study.~   "
9085|NCT02938299|"~     Phase III, open-label, randomized, controlled multi-center study. In the study, 214 patients~     will be enrolled and parallel assigned (via randomization system) in a 1:1 fashion to one of~     two different arms.~   "
9086|NCT02938286|"~     The purpose of this study is to compare the effect of pretreatment with two different~     ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser~     density in fractional laser assisted topical anesthesia.~   "
9087|NCT02938273|"~     This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent~     radiotherapy with intravenous administration of cetuximab and avelumab followed by avelumab~     maintenance therapy in patients with locally advanced head and neck cancer, unfit for~     cisplatin.~   "
9088|NCT02938260|"~     Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all~     hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of~     those presenting to the ED with AF are admitted. There are also numerous reasons for~     patients to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute~     setting these patients are often treated with diltiazem, a non-dihydropyridine calcium~     channel blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium~     channel blocker (diltiazem and verapamil) use is considered harmful and national guidelines~     recommend against use in patients with decompensated heart failure (HF). This recommendation~     is based on studies with long-term treatment. The purpose of this study is to assess the~     difference between metoprolol and diltiazem for the acute treatment of AF RVR in patients~     with HF with reduced ejection fraction (HFrEF).~   "
9089|NCT02938247|"~     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and~     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people~   "
9090|NCT02938234|"~     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and~     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people~   "
9091|NCT02938221|"~     The study investigates the feasibility and safety of the telemedical implementation of three~     diagnostic oculomotor tests using a video-oculography device and an extended~     teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test~     for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol.~     Previously published data have shown high sensitivity and specificity of the protocol for~     the discrimination of central and peripheral causes of acute vestibular syndrome. In this~     study the three tests will be executed on 30 healthy subjects using video goggles~     (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for~     bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A~     newly developed remote control and video conferencing solution allows the execution and~     evaluation of the HINTS protocol in a telemedical setup.~      The examination is guided by a remote physician using the help of a trained assistant~     attending to the subject. Corresponding clinical bedside tests will be executed for~     comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical~     setting. Safety as well as accuracy of the telemedical versus bedside examination will be~     analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy~     for patients with acute vestibular syndrome in remote areas where specialists are rare.~   "
9092|NCT02938208|"~     This investigation is a prospective non-blinded and non-randomized clinical investigation.~     This investigation is designed to evaluate the performance (leak and comfort) as well as~     participant's overall acceptance of the Jupiter mask amongst OSA participants. A total~     number of up to 15 OSA participants who currently use full face masks will be recruited for~     the trial.~   "
9093|NCT02938195|"~     The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most~     important radiation area and hope to reduce the radiation volume and try to reduce the~     postoperative mortality and treatment-related mortality.~   "
9094|NCT02938182|"~     The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine~     may concern with platelet aggregation and paradoxical embolization. The aim of the study is~     to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.~   "
9095|NCT02938169|"~     The purpose of this study is to determine the effective exercise protocol in chronic low~     back pain patients.~   "
9142|NCT02937545|"~     This study aims to compare patient use of and satisfaction with community~     pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a~     medication therapy management (MTM) service. Pharmacist and patient outcome measures will be~     collected by surveys, interviews, and review of pharmacy records.~   "
31477|NCT02645097|"~     This research is being done to compare two different saphenous nerve block locations and~     will help to determine which site best maintains knee strength and pain control.~   "
9096|NCT02938156|"~     Severe haemophilia A and B (SHA, SHB) are inherited bleeding disorders affecting male~     patients and are characterised by low levels of circulating clotting factors VIII and IX~     respectively. Clinically low levels present with multiple recurrent bleeds into joints and~     muscle from the first couple of years of life. In addition patients may present with~     spontaneous and potentially fatal bleeding into any organ. The mainstay of treatment is~     replacement with the missing factor in the form of intravenous injections of factor VIII and~     IX. Clotting factors can be given to treat a bleed or can be given to prevent a bleed, and~     the latter is termed prophylaxis. Regular prophylaxis is the current standard of care and~     aims to decrease spontaneous bleeding events and resulting joint damage, and this requires~     patients to self-infuse factor into their veins two to four times week. Patient's compliance~     with prescribed regimen and recommendations has a significant influence on outcomes.~      Advances in biomolecular and protein engineering have extended the duration of the effect of~     clotting factor VIII and IX through multiple mechanisms. This extension of the duration of~     the effect presents the clinician and patients with opportunities to tailor the treatment to~     their particular needs, circumstances and body other characteristics. It has been suggested~     that decreasing the frequency of infusions will improve adherence and thus contribute to~     improved outcomes.~      In rare disorders, it is an accepted fact that post-marketing studies are crucial to~     understand the generalisability of the efficacy and safety outcomes and identify any new~     safety and efficacy concerns in relation to specific population group. The investigators~     propose the development of a registry for systematic collection of information with the dual~     aim of analysing the relationship between patient and treatment characteristics, and~     outcomes, and simultaneously identify areas for practice development that can improve the~     overall quality of life experienced by the haemophilia patient community.~   "
9097|NCT02938143|"~     Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance~     in jumping athletes. Exercise therapy is considered the best initial treatment option for~     tendinopathies as clinical improvements in pain and function have been demonstrated.~     Although painful eccentric exercise protocols have been promoted as standard care based on~     positive results in early studies, a recent systematic review demonstrated that these are~     not associated with improved tendon structure and are ineffective when applied in-season.~     Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel~     concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based~     exercise protocol as it results in a less reactive tendon and ability to restore collagen~     alignment. This protocol consists of progressive isometric, isotonic, plyometric, and~     sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease~     motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to~     resume sports within the limits of pain, with improved muscle function, and sufficient~     tendon structure re-organization. The diagnostic imaging work-up of patellar tendinopathy~     typically consists of ultrasound, magnetic resonance imaging (MRI), or a combination of~     both. Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment~     of tissues with short T2-time, such as tendon, the structure of which is invisible on~     regular MRI. UTE has been shown to quantitatively depict changes in tendon microstructure~     and therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown~     whether quantitative UTE MRI parameters change after exercise treatment, are related to~     clinical symptoms of patellar tendinopathy, have prognostic value for exercise treatment~     response, and offer additional value over ultrasound~   "
9098|NCT02938130|"~     People with disabilities experience a staggering incidence of secondary conditions that can~     result in death or negatively impact their health, participation in the community, and~     quality of life. Many of these chronic secondary conditions are preventable. The Institute~     for Healthcare Improvement has advocated for optimizing care through programs that~     simultaneously improve health and the patient experience of care, while reducing cost,~     called the Triple Aim. Studies have shown that the Triple Aim can be achieved through~     programs that facilitate community integration; however the U.S. healthcare system lacks a~     paradigm of care for individuals with disabilities that promotes community integration. In~     order to identify potential models of healthcare delivery for individuals with disabilities~     that are effective in achieving the Triple Aim, we will conduct a rigorous research project~     to evaluate the impact of two different models of care on the Triple Aim: 1) a~     community-based care management program delivered by a non-profit organization through~     waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to~     younger individuals with disabilities between ages 55-64.~   "
9099|NCT02938117|"~     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle wich permits~     eccentric (ECC) lower limbs contractions at a defined power output. With this type of~     ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the~     same power output. Consequently, ECC program could be used in chronic disorders with limited~     capacities, such as obesity.~      The investigators hypothesis that an eccentric training program, as it will induce higher~     mechanical constraints, would improve body composition, especially by reducing fat mass.~     This effect could be explained by an increased rest energy expenditure and a better~     improvement in biological parameters (particularly lipid profile and insulin-resistance)~     after ECC training (versus CON training).~      This study aims to compare the modification of fat mass after an ECC program versus a CON~     program at the same VO2. The secondary goal is to assess the physiological mechanisms~     involved in the modification of body composition~   "
9100|NCT02938104|"~     The investigators propose a randomized controlled study in patients undergoing lung~     resection for cancer to compare the impact of multimodal intervention composed of exercise,~     nutritional supplement and psychological well-being on functional exercise capacity. One~     group (rehabilitation group) will receive the multimodal intervention after surgery for 8~     weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop~     (prehabilitation group). In this case, both groups will be exposed to the program, which~     will be available to both groups postoperatively. One of the two groups will start this~     program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will~     start once they leave the hospital and continue for 8 weeks postoperatively.~   "
9101|NCT02938091|"~     The investigators evaluated dietary modulation of LIPC rs1800588 (-514 C/T) for lipids and~     glucose using a randomized cross-over design comparing a high-fat Western diet and a low-fat~     traditional Hispanic diet in Caribbean Hispanics (n=42; 4 weeks/phase).~   "
9102|NCT02938078|"~     The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days~     and (2) the change in signs and symptoms of ocular surface disease in demodex-positive~     subjects beginning the use of Avenova.~   "
9103|NCT02938065|"~     The proposed study will use this technology to observe emptying of the stomach of a protein~     and carbohydrate rich clear liquid sports/nutrition drink.~   "
9104|NCT02938052|"~     The focus of this study is to examine the feasibility, acceptability, and preliminary impact~     of our customized positive psychology (PP)-based health behavior intervention in a group of~     patients with mild to moderate heart failure (HF).~   "
9105|NCT02938039|"~     This study will guide the anesthetists regarding the appropriate selection of the LMA in~     neonatal age group based on scientific basis.~      This study will add up to existing literature about the safety of LMA usage in neonates and~     infants. Furthermore it may shed some light on which LMA type will be more feasible and~     effective for neonatal/ infants usage.~   "
9106|NCT02938026|"~     Nutrition therapy is recognized as one of the crucial components for the standard treatment~     of diabetes along with physical activity and drug therapy. Of note, dietary habits are~     culture specific and hence understanding the dietary intake, eating behavior and physical~     activity level of the local population is important to formulate effective nutrition and~     lifestyle strategies. Weight control is a major therapeutic challenge because many~     conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause~     weight gain, thus setting up a vicious cycle with increasing insulin resistance due to~     increasing levels of free fatty acids from adipose tissues . Although intensive face-to-face~     lifestyle intervention program has showed that even modest weight loss in people with Type 2~     diabetes (T2DM) who were overweight or obese was associated with improvements in glycemic~     control and associated conditions, it may not be feasible in public hospital setting in Hong~     Kong due to factors such as limited resources, scheduling, patient's employment and~     willingness for frequent travel to the clinic. Hence, alternative strategies such as a~     combination of face- to-face individual dietary and lifestyle consultation together with~     telephone intensive lifestyle reinforcement program will likely to be an useful strategy to~     engage those obese T2DM patients through frequent individual contacts. On the other hand,~     bariatric surgery has emerged as an impressive therapeutic option for poorly control obese~     T2DM patients.~      Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong~     Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical~     trial with two main objectives:~        1. To study and compare the glycemic and weight improvement after bariatric surgery versus~          a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese~          obese patients with type 2 diabetes.~        2. To investigate the effect of lifestyle factors including dietary intake, eating~          behaviors and physical activity level on the glycemic and weight control of Hong Kong~          Chinese obese patients with type 2 diabetes.~   "
9107|NCT02938013|"~     Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus~     (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three~     (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)~   "
9108|NCT02938000|"~     This pilot study intends to evaluate an online exercise video rehabilitation program for~     stroke survivors with moderate disability compared to usual care. The intervention videos~     combine aerobic and resistance training using a latex resistance band, Thera band® elastic~     band, specifically designed for rehabilitation. This study will aim to show that for~     patients suffering acute ischemic stroke resulting in disability, at-home physical therapy~     with aerobic exercise videos will improve depression level and aerobic capacity more than~     usual care.~   "
9109|NCT02937987|"~     The objective of this study is to describe and examine the dietary intake, eating behavior~     and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association~     with weight and glycemic control at baseline and 1 year follow-up. The investigators~     hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern~     and low physical activity level are associated with poorer glycemic and weight control, and~     there will be no improvement with weight and glycemic control under usual care after 1 year.~   "
9110|NCT02937974|"~     Objective: A prospective multicenter randomized controlled trial to assess the efficacy and~     safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary~     disease(AECOPD).~      Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They~     will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing~     injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the~     agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12~     hours. administration of the agent for consecutive 5 days. Compare the following index~     between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg~     cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.~   "
9111|NCT02937961|"~     Consecutive patients with cirrhosis and septic shock with AKI who give written informed~     consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will~     be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be~     stored. Septic shock will be defined by the presence of two or more diagnostic criteria for~     the systemic inflammatory response syndrome, proven or suspected infection with hypotension~     non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume~     variation on flow track and need of a vasopressor to achieve a target mean arterial pressure~     (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also~     be done. Patients with age less than 18 years, severe known cardiopulmonary disease~     (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic~     kidney disease on hemodialysis, patients already meeting emergency criteria for immediate~     hemodialysis at the time of randomization as specified in the late group, patients~     transferred from other hospitals who have already been on hemodialysis before their arrival~     in the intensive care unit, extremely moribund patients with an expected life expectancy of~     less than 24 hours, failure to give informed consent from family members.~   "
9112|NCT02937948|"~     This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT)~     in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and~     gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative~     IMRT strategy.~   "
9113|NCT02937935|"~     Intervention: All patients at presentation would be assessed for the underlying cause of and~     will be managed by removal of all precipitants(careful review of medications, diuretics,~     nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step~     would be to consider plasma volume expansion in patients with hypovolemia (the choice of~     fluid could either be a crystalloid or albumin or even blood as indicated) along with~     identification and early treatment of bacterial infections. Along with this patients with a~     differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide~     midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis~     of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further,~     patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid~     resuscitation and vasoconstrictors would also be subjected to randomization.~        1. In the on-demand group patients would get dialysis only when patient fulfills absolute~          criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia,~          refractory fluid overload (non-responsive to diuretics) or oliguria with urine output~          of less than 0.5ml/kg for more than 24-48 hours from the time of randomization~        2. In the protocol guided group patients all patients would be considered for dialysis~          within 6 hours of randomization After randomization patients would receive dialysis as~          three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate~          flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration~          and/or diffusion in continuous form until recovery of renal functions~   "
33290|NCT02621307|"~     The purpose of this study is to determine whether drinks containing Salvia hispanica L~     (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy~     individuals.~   "
9114|NCT02937922|"~     Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients~     with hypertension. Increasing physical activity levels and/or physical exercise are part of~     the recommendations of antihypertensive therapy. However, the effects of oscillations and/or~     increase the systemic blood pressure induced by exercise session on endothelial function has~     not been studied.~      Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined~     exercise on endothelial injury levels in patients with hypertension.~      Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will~     perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40~     minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of~     one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20~     minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood~     will be collected 10 minutes before, 10 and 60 minutes after intervention for the~     quantification of endothelial microparticles (MPE) circulating (induced endothelial lesion)~     and endothelial progenitor cells (EPC) circulating (endothelial recovery capacity) by flow~     cytometry. Ambulatory blood pressure monitoring (ABPM) will be held before and after the~     intervention. Ultrasonography is used to measure the flow-mediated dilation of the brachial~     artery 10 minutes before, 10, 30 and 60 minutes after the intervention.~      Statistics: generalized estimating equation (GEE) for repeated measurements and Person~     correlation, being significant p < 0.05.~      It is expected to show results to ensure cardiovascular protection in patients with~     hypertension caused by different types of exercise and consequent endothelial injury and~     release induced regenerative factors. Knowledge of the magnitude of injury and endothelial~     recovery provided by different types of exercise can contribute scientifically to health~     professionals aimed at prescribing exercise with a vascular protective vision in patients~     with hypertension.~   "
9115|NCT02937909|"~     This study is designed to investigate whether the adoption of the use of a range of wound~     care products from a single manufacturer makes training in appropriate product selection~     more effective and results in more accurate selection of the appropriate product for the~     wound and for the patient's lifestyle, thereby incurring less waste and reducing the number~     of referrals by the community nursing team to the Tissue Viability Team.~      One community nursing team will switch to using a full range of dressings and compression~     products from BSN medical UK for three months. Nurse training on the products will be given~     and nurse competencies and confidence in woundcare and appropriate product selection will be~     tested at the start and end of the study.~      The number and type of referrals to the Tissue Viability Team will be measured.~      Total anonymised data on numbers of referrals, wound closure, numbers of wounds and quantity~     and cost of products used will be collected and compared with the historical record for~     three months prior to the study. Patients will complete a Quality of Life questionnaire at~     enrolment and exit from the study.~      Patients for whom BSN medical UK products are not appropriate or not desired by the patient~     will not be enrolled and will receive the usual range of products available to the community~     nursing team.~   "
9116|NCT02937896|"~     The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal~     desmopressin in renal colic patients pain control.~   "
9117|NCT02937883|"~     The purpose of this study is to evaluate the effects of an empowerment intervention for~     community-dwelling persons with young onset dementia and their informal caregivers.~   "
9118|NCT02937870|"~     The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite~     force study will be to compare bite force measurements over a 12 hour period across two~     (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive~     control), and a negative/no treatment control.~   "
9119|NCT02937857|"~     This is a multicenter, randomized, open Label,add-on study.~   "
9120|NCT02937844|"~     CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether~     this new generation of cell-based immunotherapy can be applied to solid tumors remain to be~     investigated, partly due to hostile immune-suppressive tumor microenvironment which favors~     tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its~     ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is~     over-expressed in 88% of glioblastoma.~      We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1~     fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR~     modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to~     activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of~     the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated~     into the CSR vector and is used for in vivo tracking and ablation of CSR T cells when~     necessary. This pilot study is to determine the safety and efficacy of autologous CSR T~     cells in patients with recurrent glioblastoma.~   "
9121|NCT02937831|"~     The purpose of this survey is to understand the following items observed in the actual~     clinical use of RIXUBIS.~        1. Unexpected adverse drug reactions~        2. Occurrence of adverse drug reactions in the actual clinical use~        3. Factors that may affect safety and effectiveness~        4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX~          deficiency~        5. Safety and effectiveness for hemophilia B patients who received routine prophylactic~          therapy, on-demand therapy and perioperative therapy~   "
9122|NCT02937818|"~     Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm,~     signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who~     have refractory or resistant disease from prior platinum-based chemotherapy.~   "
9123|NCT02937805|"~     Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen.~     Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of~     intimate area. The objective of this study is to investigate the effects of a non-hormonal~     moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.~   "
9124|NCT02937792|"~     To test the safety of high dose spinal in elective CS after prolonged sitting position.~   "
9138|NCT02937597|"~     Objective:~      To determine the effectiveness of proficiency based inter-professional communication~     training in an online environment on medical student's use of the ISBAR (Identify,~     Situation, Background, Assessment, Recommendation) communication escalation protocol in the~     deteriorating patient~      Setting: The study will be conducted in University College Cork, Ireland. Participants:~     Fifth year medical students, who are scheduled to undertake ISBAR training as part of the~     National Early Warning Score (NEWS) programme.~      Intervention: Participants will be prospectively randomized to one of three groups for~     training before undertaking a performance assessment of an ISBAR communication relevant to a~     deteriorating patient in a low fidelity simulation environment: HSE group (the national~     e-learning programme only); S group (national e- learning plus access to online scenarios~     and facilitator when requested) and PBP group (national e-learning plus access to online~     scenarios training course with in-built proficiency-based progression, and facilitator when~     requested).~      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication~     in the context of an acutely deteriorating patient.~   "
9125|NCT02937779|"~     The World Health Organization recommends that all high endemic countries for HBV infection~     based their mother to child transmission prevention strategies on vaccination of all~     children and administration of immunoglobulins (HBIG) to infants born to infected mothers in~     the first 24 hours after birth. Lack of access to antenatal screening and to HBIG~     significantly results in failure of this strategy in many countries. Moreover, despite~     sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are~     still infected, as high levels of HBV replication occurring in the third quarter of~     pregnancy act as a major risk factor.~      The objective of this study is to assess the effectiveness of an operational strategy to~     prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests~     HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a~     positive HBeAg test with a test and treat strategy for those seen for Antenatal Care (ANC)~     from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out~     according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14~     weeks of age.~      A phase IV multicenter observational and interventional non randomized prospective study~     will be conducted in 4 maternity in Cambodia.~      The primary outcome will be the proportion of active HBV infection in new-born at 6 months~     of life estimated by HBs Ag positivity.~      The study will aim to document the acceptability and the operational implementation of the~     study using rapid tests usable in all health centers and a drug available in all the country~     thanks to HIV national program. The results will be helpful for Cambodian government in~     order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.~   "
9126|NCT02937766|"~     To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered~     subcutaneously via auto-injector is associated with less pain as compared to intramuscular~     injections of Makena®~   "
9127|NCT02937740|"~     Multicenter study consisting of two study periods as follows: a 90-day Treatment Period,~     with potential extension by 30 days for those patients requiring a dose increase, as~     determined by the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of~     testosterone) per nostril twice daily may have an increased daily dose adjustment on Day 90,~     based on their hypogonadism symptoms.~   "
9128|NCT02937727|"~     Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's~     disease (PD), but it is not optimally effective for controlling every motor sign and adverse~     events are not so infrequent. Therefore,other approaches should be considered. New~     Approaches in MRI at 3T Dedicated to Targeting Subthalamic Nucleus on Parkinson Patients.~   "
9129|NCT02937714|"~     Significantly higher prevalence of emotional and behavioural problems have been reported~     from Pakistan.This higher prevalence along with stigma of psychiatric problems and limited~     child & adolescent mental health services in Pakistan means that it is important to consider~     alternate methods for promoting psychological and emotional well-being of our youth. Schools~     can thus act as a natural platform for mental health promotion as schools context has almost~     as much impact on students' emotional health as the family context.~      Teachers' role in the school mental health initiatives cannot be overemphasized. Teachers~     own knowledge and beliefs regarding mental health influence the way they respond to students~     mental health crisis. Recognizing the need for wider implementation of evidence based school~     mental health interventions in the region and to help in addressing the mental health~     literacy of educators in resource constrained settings, World Health Organization, Eastern~     Mediterranean Region (WHO-EMRO) has developed a concise and practical manual of school~     mental health in December 2014. In the absence of any whole school approach study from~     Pakistan focusing on teachers training and addressing all the various evidence based~     components of promotion of positive mental health, Investigators aim to conduct a pilot~     randomized controlled trial to assess effectiveness of training based on WHO-EMRO manual, in~     addition to its feasibility & acceptability in improving teachers' mental health literacy~     and self-efficacy in dealing with students mental health issues.~      HYPOTHESIS:~      For teachers:~        -  School mental health training intervention will significantly improve teacher's mental~          health literacy & self-efficacy compared to wait list control group.~        -  At 3 months follow-up, control group teachers' mental health literacy will also improve~          compared to baseline due to contamination of information provided, across groups within~          the same school.~      All hypothesis pertains to individual level.~      For students:~      Mental health training of teachers would lead to an overall improvement in student's outcome~     measure (student's emotional and behavioural difficulties) at 3 months follow-up.~   "
9130|NCT02937701|"~     This trial is designed to determine what effects the human body has on the investigational~     medicine, ABP 710, and what effects the body has on the investigational medicine after you~     have been given it, and if this is comparable to what is seen for the licensed medicine,~     infliximab, in patients with moderate or severe rheumatoid arthritis (RA).~      This study will assess if the investigational medicine is safe and effective in~      treating moderate or severe RA compared to the licensed medicine.~   "
9131|NCT02937688|"~     To gather data on DBS Therapy effectiveness in different geographic populations.~   "
9132|NCT02937675|"~     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and~     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     antitumor activity of eFT508. The study will evaluate oral daily administration of eFT508.~     Treatment and study subject evaluation will be performed in 21-day cycles.~   "
9133|NCT02937662|"~     In this multi-center, randomized, open-label, prospective clinical trial, a total of 60~     relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm,~     patients receive IAC regimen. In the control arm, patients receive other physician-directed~     regimen. The primary end point is complete remission rate.~   "
9134|NCT02937649|"~     Staple-line leak is the most frequent and incapacitating complication after laparoscopic~     sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the~     staple-line leak rate after LSG according to the use of a bougie calibre of 36 or 48-Fr,~     assuming that a higher diameter is correlated with a lower risk of leak, without lowering~     long-term weight loss.~   "
9135|NCT02937636|"~     This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group~     clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice~     compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs~     of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12~     weeks use in a Chinese population.~   "
9136|NCT02937623|"~     A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment~     group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in~     relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after~     application compared to no treatment.~   "
9139|NCT02937584|"~     To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily~     (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway~     volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary~     disease (COPD) following chronic dosing after approximately two weeks treatment.~   "
9144|NCT02937519|"~     1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and~          intensity modulated radiotherapy term efficacy of the treatment of locally advanced~          nasopharyngeal carcinoma.~        2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity~          modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and~          tolerability.~      3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy~     group can achieve lower toxicity, improve the curative effect, for the treatment of~     nasopharyngeal carcinoma provides a more reasonable way.~   "
9145|NCT02937506|"~     The primary purpose of this study is to determine if patient satisfaction with propofol is~     better than with non-propofol anesthesia for outpatient colonoscopies.~   "
9146|NCT02937493|"~     A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical~     University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out~     of this patient population a total of 1.406 cases associated with IPV have been~     consecutively and prospectively included in our in-house screening service for IPV cases.~     Data collection was performed prospectively and statistical evaluation was performed~     retrospectively, approved by local IRB (1453/2016).~   "
9147|NCT02937480|"~     The majority of people after stroke demonstrate mobility limitations, which may reduce their~     physical activity levels. Task-specific training has shown to be an effective intervention~     to improve mobility in individuals with stroke, however, little is known about the impact of~     this intervention on levels of physical activity. The main objective will be to investigate~     the efficacy of a task-specific training, focused on both upper and lower limbs, in~     improving physical activity levels and mobility in individuals with stroke. The secondary~     objective will be to investigate the effect of the training, in improving muscle strength,~     exercise capacity, and quality of life. A randomized controlled trial with blinded~     assessment will assign eligible participants to either: 1) experimental group or 2) control~     group. Participants will receive interventions three times per week over 12 weeks. The~     experimental group will undertake task-specific training, while the control group will~     undertake global stretching and memory exercises, and health education sessions. Primary~     outcomes will include measures of physical activity levels and mobility, whereas secondary~     outcomes will be muscle strength, exercise capacity, and quality of life. The outcomes will~     be measured at baseline, 12 weeks post-intervention, and four and 12 weeks follow-up. The~     findings of this trial have the potential to provide important insights regarding the~     effects of task-specific training, focused on both upper and lower limbs, in preventing~     secondary post-stroke complications and improving the participants' general health through~     changes in physical activity levels.~   "
9148|NCT02937467|"~     The incidence rates of thyroid cancers have increased in the past decade. Additionally, up~     to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules~     is very important and can avoid unnecessary biopsy of benign nodules. Shear wave~     elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time,~     quantitative, operator-independent, and reproducible technique. Briefly, shear wave~     elastography uses a radiation force produced by an ultrasonic beam to stress tissues and~     ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the~     Young modulus formula, tissue elasticity can be derived from the shear wave propagation~     speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in~     blue and stiffer tissue in red.~      There are lots of research confirmed that SWE has a certain value in the diagnosis of~     thyroid carcinoma. These studies include prospective studies and retrospective studies, but~     both belong to a single center study. It has not been applied to the study of the~     multicenter of thyroid disease.~      The main purpose of the study is to assess the performance of SWE for identification of~     benign and malignant thyroid nodules and calculate the optimal cutoff value for each~     parameter in multicenter study; the secondary purpose is to evaluate the application value~     of SWE for uncertain nodules by FNA.~   "
9149|NCT02937454|"~     Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and~     Iron Deficiency (Affirm-AHF)~   "
9150|NCT02937441|"~     The purpose of this study is to determine cerebral edema with evaluation of measurement of~     diameter of optic nerve sheath.~   "
9151|NCT02937428|"~     It is common for people to advise individuals undergoing vaccination to look away from the~     needle to make them hurt less and be less scary. However, this advice is not backed up by~     research evidence. the purpose of this study is to learn about how looking away vs. looking~     at the needle during vaccination makes people feel. People will be randomized to 1 of 2~     groups: look at the needle, look away. Then they will undergo vaccination and report on pain~     and fear experienced.~   "
9152|NCT02937415|"~     Waterpipe is a tool for smoking tobacco, which is thought to be less harmful than cigarette.~     Unfortunately, there aren't adequate studies about its harms to health that are threatening~     the young generation all over the world today. The objective of this study was to show the~     carbon monoxide (CO) levels in waterpipe smokers' breaths, whether can be used or not to~     reflect the changes of oxidative stress for this reason to predict harmful effects on the~     pulmonary functions.~   "
9153|NCT02937402|"~     This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in~     identifying biomarkers of response to immune checkpoint inhibitors in patients with~     non-small cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument~     inserted through the nose or mouth to view the inside of the trachea, air passages, and~     lungs. Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid.~     Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers~     that are more present in some cancers than others that will help determine which individuals~     have a greater or lesser chance of benefiting from immunotherapy.~   "
9154|NCT02937389|"~     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical~     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and~     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic~     evaluation about reconstructive organs after esophagectomy. The investigators evaluate~     endoscopic predictions using classifications in acute phase after esophagogastrostomy.~   "
9155|NCT02937376|"~     The purpose of this study is to investigate the effects of N-acetyl Cystein (NAC)~     supplementation on redox status, physiological and biochemical parameters in G6PD deficient~     individuals after acute exercise.~   "
9157|NCT02937350|"~     The goal of this study is to better understand vitamin D catabolism and how it is affected~     by CKD and race. Specifically, we will evaluate the metabolic clearance of 25-hydroxyvitamin~     D3 in individuals with varying degrees of CKD and among participants who self-report race as~     Caucasian, African American or African. The long-term goal of this work is to enhance the~     clinical evaluation and treatment of impaired vitamin D metabolism.~   "
9158|NCT02937337|"~     In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided~     laryngeal mask airway real time insertion technique with the standard recommended index~     finger-guided insertion technique in pediatric patients.~   "
9159|NCT02937324|"~     This study compares the comparing the validity and usability of smartphone software for home~     monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical~     gold standard - the Unified Parkinsons Disease Rating Scale.~   "
9160|NCT02937311|"~     This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation~     (NMES), and neuromuscular training on pain, and motor activity and function in patients with~     upper extremity hemiplegia.~   "
9161|NCT02937298|"~     Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst~     over 50% of a person's energy requirement goes towards the maintenance of physiological~     functions, around 40% is used for physical activity. In addition to this, around 10-15% of~     energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced~     Thermogenesis is the increase in energy expenditure following a meal, and represents the~     energy utilised for the digestion and metabolism of food. Some nutrients such as proteins~     require more energy to digest and therefore produce a greater DIT than others. In addition~     to this, some food components are able to independently stimulate calorie burning. For~     example caffeine, chilli, ginger and green tea have been shown to induce calorie burning~     through DIT. Therefore the inclusion of such foods in the diet could increase energy~     expenditure and thereby help in weight control.~      The objective of this study is to determine the DIT effects of some plant foods that are~     native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea~     buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to~     be effective, these foods could then be used to develop dietary strategies for weight~     control in Scotland.~   "
9162|NCT02937285|"~     The relative effectiveness of current treatments and their different mechanisms of action~     yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must~     use multiple molecules, both combined and sequential.~      In this sense, one can assume that the combination of two molecules with different but~     complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a~     powerful action, immediate and total, whereas interferon a selective action,~     immunomodulatory and delayed.~   "
9163|NCT02937272|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3200882 in participants with solid tumors.~   "
9164|NCT02937259|"~     Self-admission is a novel treatment tool whereby patients who are well-known to a service~     who have high previous utilization of health care are offered the possibility of~     self-admission to the inpatient ward for up to seven days without having their motive for~     admission questioned. Patients are free to admit themselves because of deteriorating mental~     health, acute stress, lack of structure in their everyday life, loneliness, boredom, or any~     other reason. The patients decide when they want to admit themselves and can discharge~     themselves at any time. The purpose behind the self-admission model is to increase the~     availability of inpatient care for severely ill patients, to avoid stressful and possibly~     destructive visits to the emergency service, and to decrease total inpatient care~     utilization. Patients offered a contract for self-admission usually have a history of~     repeated and prolonged hospitalizations. By encouraging them to monitor their own mental~     health status and allowing them to seek help swiftly when they are feeling poorly, the delay~     from first signs of deterioration to admission can be minimized and full-blown relapse can~     be avoided, ultimately reducing the total time spent in hospital. Until now, projects of~     self-admission have mainly targeted patients with long-standing psychotic disorders, such as~     schizophrenia, or bipolar disorder. Starting in August 2014, a four-year clinical project at~     the Stockholm Centre for Eating Disorders began offering self-admission to patients with~     severe and enduring eating disorders. The purpose of this study is to determine whether this~     model is viable in a specialized eating disorders treatment setting, if it does lead to~     increased patient participation and agency and a reduction of the total time spent~     hospitalized for this particular patient group, and if it is cost-effective.~   "
9165|NCT02937246|"~     Previous studies indicated that covered stents are less likely to become occluded in~     comparison to bare stents. While the probability of occlusions caused by tumor in-growth is~     less in covered stents, they are more likely to spontaneously migrate to a position that is~     distal to the original deployment site. However, newer covered stents with improved designs,~     such as the partially covered double bare metallic stent used for this study, include~     features to mitigate the migration issue. The purpose of this study is to confirm whether~     the difference in patency rate between regular covered stents and bare stents, which has~     already been well established by existing studies, is also reproducible when double covered~     stents are compared against double bare stents.~   "
9166|NCT02937233|"~     This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated~     Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind,~     randomized allocation of study product. There are four groups in the study. Each group is~     testing a different vaccine schedule.~   "
9167|NCT02937220|"~     The aim of this study is to evaluate the influence of superstructure material on crestal~     bone resorption and esthetic outcome of dental implants in patients with single missing~     tooth in the aesthetic zone.~   "
9168|NCT02937207|"~     The purpose of this study is to evaluate the clinical efficacy of traditional Chinese~     medicine in the treatment of asthma, and to promote the application in community hospitals.~   "
9222|NCT02936505|"~     A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive~     protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate~     mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction~     (CLAD) after lung transplantation, in comparison with a standard cyclosporin-based protocol.~   "
9223|NCT02936492|"~     Systemic safety following single and multiple dermal administration of BAY1003803~   "
9169|NCT02937194|"~     Early childhood caries (ECC) is a global health problem that causes pain and infection to~     the children affected. It is a common disease among preschool children in Hong Kong. There~     is a great need to improve at-home ECC preventive measures through oral health promotional~     activities as early as possible to parents.~      The investigators will propose a 4-year randomized controlled trial of family-centered oral~     health promotion for new parents which aims to increase the proportion of parents brushing~     their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the~     transfer of MS from the parents to their infants and then reducing the risk of ECC of the~     children at 3 years. The investigators also aim to improve the oral hygiene status of the~     new parents and prevention of oral diseases among themselves.~      First-time expectant mothers and their husbands will be recruited. The recruited families~     will be randomly allocated to the test and control groups. In the test group, personal~     hygiene instruction (OHI) for the expectant mothers and their husbands together with oral~     health education materials on infant's tooth development and eruption, establishment of~     proper feeding, dietary and toothbrushing habits will be given before the delivery of the~     new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral~     cavities and perform toothbrushing will be delivered after the babies are born.~     Comprehensive data will be collected from the mothers, fathers and the infants in both the~     test and control groups at different time points through dental examination, biological~     testing and questionnaire survey. The CONSORT statement will be strictly followed when~     conducting the clinical trial, analyzing the data and reporting the results.~      It is anticipated that the effectiveness of oral health promotion starting at the pregnancy~     period and for both expecting mothers and their husbands will be greater in preventing the~     infants from developing ECC. Furthermore, establishing good oral health care habits will~     have long term benefits, helping safeguard the oral health of the children as they grow and~     the family as a whole. This study will also provide much needed evidence for the further~     development of oral health policies and oral health promotion programmes in Hong Kong;~     specifically how these can be integrated into family health education so as to achieve a~     higher effectiveness. This will contribute significantly to the improvement of oral health~     in the population of Hong Kong.~   "
9170|NCT02937181|"~     Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III~     open fractures~   "
9171|NCT02937168|"~     This is an exploratory study with the primary objectives to 1) establish that PET/CT of the~     lung can reliably distinguish healthy, non-asthmatic volunteers from patients with asthma~     and an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that~     reslizumab produces a reduction in lung inflammation in patients with severe asthma and an~     eosinophilic phenotype .~   "
9172|NCT02937155|"~     This study will look at cervical tissue samples in women with abnormal cervical cells to see~     if the frequency of the HPV 16/18 subtypes has changed in female populations today, after~     the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV~     vaccine with those who have not.~   "
9173|NCT02937142|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which~     starts in childhood and is characterized by symptoms of attention deficit, hyperactivity and~     impulsivity. Persistence into adolescence is frequently associated with among other low~     educational achievement, interpersonal difficulties, anxious and depressive symptoms and~     sleep problems. Treatment guidelines recommend psychological treatment as part of the~     treatment plan, however compared to children and adults, there is still a substantial lack~     of knowledge about appropriate psychological treatment in adolescents. The present study~     examines a psychological intervention for adolescents with ADHD, cognitive behavior group~     therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions~     addressing core difficulties and concerns of the adolescent population with ADHD. The~     investigators wish to determine the efficacy of group therapy in adolescents with ADHD who~     receive medical treatment but still have impairing ADHD symptoms.~   "
9174|NCT02937129|"~     The primary aim of this study was to determine the accuracy of an infrared thermometer~     compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to~     compare tympanic and axillary temperature measurements by evaluating agreement and~     correlation to determine whether an infrared tympanic thermometer can replace an axillary~     mercury thermometer in the emergency department.~   "
9175|NCT02937116|"~     The purpose of this study is to determine the safety, tolerability and efficacy of IBI308~     monotherapy or in combination with chemotherapy in patients with certain types of advanced~     solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and~     immunogenicity of IBI308~   "
9176|NCT02937103|"~     The overall purpose of this study is to explore the therapeutic effect of CD123-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.~   "
9177|NCT02937090|"~     Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on~     intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota~     maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the~     investigators will compare the intestinal microbiota composition and diversity in PCOS with~     age, BMI-matched control and then assess whether intestinal microbiota modification is~     associated with clinical and biological parameters.~   "
9178|NCT02937077|"~     Background:~      Different studies with real-life data and randomized controlled trials have shown a~     detection rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic~     stroke using insertable continuous cardiac monitoring for 6 months. More studies are needed,~     however, to identify factors which can be used to select the patients where the possibility~     of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration~     of rhythm monitoring, to determine the optimal deﬁnition of short-term AF that warrants~     intervention and to evaluate whether intervention results in improved clinical outcomes.~      Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to~     evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients~     admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80~     years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for~     12 months for the purpose of AF detection. Biomarkers that may identify patients, who could~     derive the most clinical benefit from the detection of AF by prolonged monitoring, are being~     studied.~      Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in~     patients with cryptogenic stroke and TIA that potentially can improve secondary prevention.~     The study will provide information on biomarkers that may be used to select cryptogenic TIA~     and stroke patients for long-term monitoring as well as information on the significance of~     short-term AF and optimal duration of cardiac rhythm monitoring.~   "
9179|NCT02937064|"~     The purpose of this study is to assess both osteoarthritis and other pathological knee~     conditions from the combination of signals that are known to provide information on the knee~     joint.~   "
9180|NCT02937051|"~     This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who~     will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by~     the tobacco product smoked:~        1. own-brand CTC (positive control),~        2. original-flavored Black & Mild (B&M) cigar,~        3. apple-flavored B&M cigar,~        4. cream-flavored B&M cigar, and~        5. wine-flavored B&M cigar.~   "
9181|NCT02937038|"~     Purpose:~        1. Develop reference values for hydration biomarkers for children of 3 to 13 years old~        2. Explore the association between children's and parents' hydration markers and fluid~          intake habits in children aged 3-13 y~        3. Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children~          aged 3-13 y~        4. Evaluate the differences in hydration markers between school and non-school days in~          children aged 3-13 y~        5. Examine the role of different foods and fluids on hydration in children (3-13 y) and~          parents~   "
9182|NCT02937025|"~     This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage~     Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)~   "
9183|NCT02937012|"~     The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis,~     treatment is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15~     mg/kg, without other treatment options. Patients with good or complete response to UDCA have~     more liver transplant-free survival and delay histologic progression compared to patients~     with partial or no response. Nowadays there is an estimated partial response to UDCA in~     approximately 30 to 50% of patients with PBC. There is a need for new second line management~     strategies for patients without a biochemical response to UDCA.~      The addition of bezafibrate to the treatment of PBC patients with partial biochemical~     response to UDCA, will increase the biochemical response and improve the long term~     prognosis? And if so, which are the efficacy and security of bezafibrate in PBC patients~     without biochemical response?~   "
9184|NCT02936999|"~     The purpose of this study is to determine the safety and usefulness of oral Vitamin D~     supplementation in subjects with in situ carcinoma. More specifically, this study is being~     done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer~     cells and (2) the development of invasive breast cancer disease.~   "
9185|NCT02936986|"~     The differential diagnosis of gastric submucosal tumors by endoscopic ultrasound is~     currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel~     endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic~     ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at~     cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria~     for the characterization of gastric submucosal tumors, with histopathological correlation,~     and to perform the validation of these criteria.~   "
9186|NCT02936973|"~     The primary objective of this multicenter randomized controlled trial is to evaluate~     treatment effectiveness of intervening simple obesity people with catgut implantation at~     preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate~     safety and superiority of treating simple obesity with catgut implantation at acupoints to~     provide high-level evidence for it clinically.~   "
9187|NCT02936960|"~     The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided~     fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser~     endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge~     FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo~     imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe~     nCLE interpretation criteria for the characterization of pancreatic masses, with~     histopathological correlation, and to perform the validation of these criteria.~   "
9188|NCT02936947|"~     That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment~     in patients with tumors that are moving with respiration like breast or lung cancers. The~     use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory~     motions while administering radiotherapy (RT) to tumors which allows a reduction of the~     amount of irradiated normal tissues and which potentially decrease radiation-induced~     collateral damages.~   "
9189|NCT02936934|"~     The objective of this study is compare adverse reactions associated with oxycodone and~     morphine for the treatment of postoperative pain after abdominal hysterectomy~   "
9190|NCT02936921|"~     Several decades ago, France has made the choice to implement a national prevention program~     for congenital toxoplasmosis. The identification in their first trimester of pregnancy of~     all pregnant women who are susceptible to Toxoplasma infection has been mandatory since~     1985. In 1992, the decision was made to extent the program to the monthly retesting of all~     women identified as not immune, in an attempt to reduce the number of severely infected~     children.~      The systematic detection of all maternal and congenital infections has generated many~     questions from clinicians, biologists, parents and older patients, on the short and~     long-term prognosis of congenital toxoplasmosis, on the best tests to use to diagnose~     infections in mothers and children, on the efficacy of existing treatments, and on how to~     manage patients in the long-term.~      The need to answer these many questions has prompted the medical team working within the~     laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse~     Hospital in Lyon to implement a clinical research program. It is based on the systematic~     inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow~     up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children~     in order to confirm their infection or to rule it out. All congenitally infected subjects~     undergo clinical examinations, serological tests and ocular examination at least once a year~     without age limit.~      The following data are prospectively collected in a dedicated database: gestational age at~     maternal infection and corresponding serological profile; type and dates of maternal~     treatment; findings of ultrasound tests and amniotic fluid analysis; serological and~     clinical findings at birth; types and dates of postnatal treatment; postnatal serological~     profiles; infection status at one year of age; long term clinical (ophthalmologic) et~     serological findings.~      These data have allowed producing original findings on the risk of maternal-foetal~     transmission according to gestational age at maternal infection, on the long term~     ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the~     diagnosis, treatment and follow-up of maternal and congenital infections.~      These efforts are still to be maintained in the future in order~        -  to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the~          risk of ophthalmological events~        -  to increase precision around our risk estimates for materno-foetal transmission,~        -  to continue innovating in terms of diagnostic strategy to improve tests performances~          and reduce costs~        -  to explore new potential clinical outcomes such as neuropsychiatric disorders~          associated with congenital and postnatal infection~        -  to determine if infections due to oocysts could have different clinical outcomes than~          those due to the ingestion of cysts~        -  to assess the efficacy of treatments for maternal and congenital infections~   "
9191|NCT02936908|"~     Retrospective multicentric observational study exploring the population of adult~     neuromuscular patients presenting a respiratory distress requiring their admission in an~     Intensive Care Unit (ICU) for ventilatory support.~      Research of markers associated with long term mortality and ventilatory status.~   "
9220|NCT02936531|"~     In this study the investigators aim to identify and characterize a potential~     neurophysiological biomarker by mapping functional networks of brain activity (Brain Network~     Activation, BNA) based on analysis of evoked response potential (ERP) signals in both~     asymptomatic FMR1 premutation carriers and in patients with various stages of FXTAS.~     Additionally correlations will be studied between these BNA scores and demographics (gender,~     age and disease duration) as well as genetic mutation and clinical scores.~   "
9192|NCT02936895|"~     Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in~     developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children~     under 5 years. This rate was 2% in 2007.~      Some studies have shown that supplementing with vitamin D reduces disease of the respiratory~     tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell~     lines. Studies about the role of vitamin D supplementation in pneumonia in children are~     inadequate to conclude about its role.~      The aim of this study is to determine the efficacy of vitamin D supplementation in~     Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of~     hospitalized patients with community-acquired pneumonia.~   "
9193|NCT02936882|"~     This study evaluates antral ultrasonography for the diagnosis of full stomach before~     surgical emergencies in pediatric population. Preoperative ultrasonographic antral~     evaluation is compared to peroperative gastric aspirate with nasogastric tube.~   "
9194|NCT02936869|"~     The purpose of this study is to identify the causal impact of performance-based monetary~     incentives in increasing postnatal care (PNC) referrals by traditional birth attendants~     (TBAs), via a randomized controlled trial (RCT).~   "
9195|NCT02936856|"~     Primary liver cancer is one of the most common malignant tumor and leading cause of~     cancer-related death worldwide. Basically therapeutic strategies were considered and given~     based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and~     distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely~     imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually~     presented untypical imaging characteristics, especially among lesions no larger than 1 cm,~     which misleading to the exact staging of liver cancer and the optimal therapeutic~     strategies.~      Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based~     on this fact, hepatic arterial digital subtraction angiography could potentially elevate the~     accuracy and sensitivity of detection malignant lesions numbers and distribution.~      In this study the investigators will compare the numbers and distribution of malignant~     lesions before and after hepatic arteriography, then to revise the staging of liver cancer~     and to provide better therapeutic strategies.~   "
9196|NCT02936843|"~     Diabetic neuropathy (DN) is the most common chronic complication of diabetes, affecting up~     to50% of individuals with type 1 diabetes (T1DM).~      Multiple pre-clinical and clinical studies demonstrate a pathogenic role for inflammation,~     especially cytokine production, in the disease course of DN and CAN. This suggests that~     agents with known anti-inflammatory properties, such as salicylates, may prevent the~     development of DN and the pain associated with DN. This study builds upon and expands on~     prior work done by the investigators with salsalate, a pro-drug form of salicylate, as an~     agent to address inflammatory pathways in people with T1DM.~   "
9197|NCT02936830|"~     The aim of this study is to compare the efficacy of dentine hypersensitivity reduction using~     in office paste formula containing nanoHydroxyapatite with the commercially available~     fluoride (duraphat) and a placebo in treating hypersensitivity in a single visit.~   "
9198|NCT02936817|"~     Primary:~      The primary objective of this study is to evaluate the effect of the Aerobika® device on the~     aerosol deposition pattern of concomitant inhalation medication using FRI.~      Secondary:~      The secondary objective of this study is to evaluate the effect of the Aerobika® device on~     the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw),~     hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping~     using FRI.~   "
9199|NCT02936804|"~     The present study is a single arm clinical trial aiming to improve the key technology in the~     diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70)~     are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm~     (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening~     test will be carried out by a pre-specified protocol.~   "
9200|NCT02936791|"~     This observational study will collect blood and urine and clinical information from~     individuals with early-stages of polycystic kidney disease (PKD), their unaffected siblings~     and normal volunteers to create a biobank, also called a biorepository. The long-term goal~     is to develop new knowledge on biological markers or biomarkers that indicate changes in the~     disease progression. An understanding of biomarkers for early renal cyst growth will benefit~     PKD patients as new therapies are being developed and tested.~   "
9201|NCT02936778|"~     This study will prospectively assess the impact and relevance of several risk factors for~     children with severe acute asthma (SAA) or acute wheeze that have been identified in~     retrospective studies. Secondary we will assess short-term medical and psychosocial~     functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a~     control group admitted to a MC for SAA/acute wheeze.~   "
9202|NCT02936765|"~     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two~     different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative~     change in neck disability index. The evaluation will include clinical and radiological~     parameters.~   "
9203|NCT02936752|"~     This phase Ib trial studies the side effects and best dose of entinostat when given together~     with pembrolizumab in treating patients with myelodysplastic syndrome after deoxyribonucleic~     acid (DNA) methyltransferase inhibitor (DNMTi) therapy failure. Entinostat may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow~     and spread. Giving entinostat together with pembrolizumab may work better in treating~     patients with myelodysplastic syndrome after DNMTi therapy failure.~   "
9204|NCT02936739|"~     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two~     different cervical disc prosthetic devices with respect to postoperative change in neck~     disability index. The evaluation will include clinical and radiological parameters.~   "
9221|NCT02936518|"~     A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified~     breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy.~     In the previous cohort, babies were excluded from the study if they had previously undergone~     an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only~     look at those babies who did undergo a previous frenotomy to determine:~        1. the presence of continued problematic breastfeeding symptoms~        2. if further tongue tie or lip tie release improves those outcomes~   "
9205|NCT02936726|"~     There is evidently great potential in implementing workplace health promotion programs, but~     more randomized trials are needed to determine which interventions are worksite-effective in~     helping to decrease inactive behaviors and increase engagement in healthy lifestyle~     activities. For employers, it could mean improving the health and productivity of employees.~     For workers, especially those in physically and/or psychologically demanding positions, it~     could mean developing strength, muscular endurance and agility to reduce musculoskeletal~     pain while developing the stress reduction skills that reduce long-term sickness and~     absenteeism risks. While changing behavior in a complex workplace is, as seen in multiple~     studies, difficult due to the need to change workplace and organizational culture between~     employers and employees, this study aims to identify the effectiveness of workplace~     interventions in relation to counseling for university employees to increase overall work~     fitness without affecting any hierarchal interactions at the work site. Simply put, the~     investigators will examine the benefits of a workplace exercise and mindfulness (two-prong)~     intervention (in combination) vs. a group who just receive a workplace exercise~     intervention. Both interventions will be guided by health coaches. Given the limited~     research with health coaching and workplace interventions for university workers, the aim is~     to contribute to a developing research literature. This study is geared to engage university~     employees at their workplace over a 3 month period. Participants will be assessed through~     pre and post physical and psychological measures and will also undergo semi-structured~     interviews (SSI).~   "
9206|NCT02936713|"~     To select among different dietary and clinical conditions the most appropriate to assess the~     impact of a fermented milk product on gas-related symptoms~   "
9207|NCT02936700|"~     Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000~     suicide attempts every year. SB management is therefore a major public health issue.~     Recently, investigators have demonstrated the interest of acceptance and commitment therapy~     (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in~     depressed patients having a history of suicide attempt within previous year (i.e actual SB~     disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth~     edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal~     and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly,~     previous functional MRI (fMRI) studies have also reported the modulation of these regions by~     ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to~     identify biomarkers of SB and its improvement by ACT.~      The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB~     disorder. Patients having a history of SB within previous year were randomized in an ACT~     program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after~     the completion of the group, they performed 3 tasks during fMRI: implicit emotional~     visualization, Cyberball game, motivational task Investigators will compare cerebral~     activations between groups, between pre and post intervention as well as measure baseline~     cerebral activations associated with improvement of suicidal ideation during follow up.~   "
9208|NCT02936687|"~     The objective of this study is to identify insulin-specific cerebral blood flow (CBF)~     control mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs)~     metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of~     cardiovascular mortality even if they never develop diabetes. The central hypothesis is that~     vasodilator actions of insulin are impaired in MetSyn due to loss of dilator and gain of~     constrictor signals. This study will focus on 2 mechanisms that likely limit CBF in MetSyn:~     1) Disruption of nitric oxide (NO) vasodilation, and 2) Exaggerated endothelin (ET-1)~     constriction. Three specific aims will be addressed: Aim 1: To test the hypothesis that~     physiologic surges of insulin acutely increase CBF in young adults, but adults with MetSyn~     exhibit paradoxical insulin-mediated vasoconstriction. Aim 2: To test the hypotheses that~     key mechanisms responsible for poor CBF in MetSyn are shifts in NO and ET-1 signaling.~     Specifically, in healthy controls, NO mediates robust dilation, with little to no ET-1~     constriction. In contrast, adults with MetSyn exhibit uncoupled NO synthase (NOS) and~     exaggerated ET-1 constriction. Aim 3: To test the hypothesis that insulin regulation of CBF~     is regionally distinct (e.g. Middle Cerebral Artery (MCA) reactive than Anterior Cerebral~     Artery (ACA) or basilar), and the negative effects of insulin resistance (IR) are similarly~     regionally specific.~   "
9209|NCT02936674|"~     The purpose of this study is to examine the effects of complex, broad-band spectra light on~     the production of melatonin in humans.~   "
9210|NCT02936661|"~     It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500~     women to delivery by cesarean section will be recruited in this study. In addition to~     routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they~     delivered their babies, and those in control group will receive placebo. The incidence of~     postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.~   "
9211|NCT02936648|"~     The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to:~     (1) increase the proportion of Veterans tested for HCV in those born between 1945-1965 and~     in vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1~     VA Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender,~     or other markers of social disparity influence completion of HCV testing and linkage to~     specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality~     Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to~     treatment evaluation, management of comorbidities and contraindications, and subsequent~     initiation.~   "
9212|NCT02936635|"~     The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv~     in patients with ALS.~   "
9213|NCT02936622|"~     This randomized multi-center study is intended to compare different coatings on stents for~     treatment of lesions of the above-the-knee femoropopliteal artery.~   "
9214|NCT02936609|"~     This innovative and timely study will measure the impact of Affordable Care Act (ACA)~     Medicaid expansions on cancer screenings and preventive services. To assess this natural~     policy experiment, the investigators will use electronic health record data from the~     Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical~     data research network (CDRN) of the National Patient-Centered Clinical Research Network~     (PCORnet).~   "
9225|NCT02936466|"~     Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic,~     and depressive episodes. Major risks factors of relapses are poor compliance, sleep~     disorder, and toxics consumption. The aims of psychoeducation programs are to increase~     compliance and knowledge about bipolar disorder. Serious game are supposed, in bipolar~     disorder, to strengthen the efficacy of psychoeducation programs. Bipolife® is a serious~     game which purpose is to help bipolar patients to deal with their conditions, through 3~     mains messages : to pursue the treatment, to have daily routine and to request the~     psychiatrist in case of relapse.~      This is a multicentric randomized controlled study with two harms parallels. After a classic~     psychoeducation group program, patients are randomized in two groups : interventional group~     and control group with treatment as usual.~      The main objective is to evaluate the observance in the two groups. The other objectives are~     to evaluate daily routine, global functioning, and access to health care. Evaluations are~     realized at one and four months after inclusion visit. Acceptability and satisfaction about~     the serious game Bipolife® will be assessed in the interventional group.~   "
9226|NCT02936453|"~     STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop~     Epidural Electrical Stimulation (EES) in combination with overground robot assisted~     rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).~      Patients will participate during 9-11 months, during which there will be~        -  Pre-implant evaluations (6-8 weeks)~        -  Device implantation and stimulation optimization (6-8 weeks)~        -  Overground rehabilitation training with EES (5-6 months) In the period after~          implantation, participants need to be present for testing and training, 4 days per week~          at the CHUV University Hospital in Lausanne (lodging can be provided).~      At the end of the protocol, the study aims to make the patients walk better and faster,~     however, as this is the first study of its kind, success is not guaranteed.~   "
9227|NCT02936440|"~     The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is~     associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears~     to be a viable method to access the fluid status of critical patients but has never been~     evaluated in critical patients with AKI. The objective of this study is to evaluate the~     hydration status using BIVA in critical patients under intensive care at the time of AKI~     diagnosis and to correlate this measurement with mortality. A sample of 224 patients with~     AKI will be evaluated by BIVA and followed until they are discharged or death in intensive~     care unit and the BIVA vectors will be analysed to define differences in hydration~     characteristics from each group.~   "
9228|NCT02936427|"~     Post-op analgesia is the most important part of early and safe patient recovery in thoracic~     surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly~     improved with optimal pain control and complications and length of stay are minimized. Most~     post-op thoracic complications are from decreased respiratory effort, failure to clear~     secretions and pulmonary infections from retained sputum with subsequent sequelae. Good~     post-operative analgesia not only prevents these complications but also considerably~     enhances early mobilization and thus, decreased hospital stay and efficient resource~     allocation. Early post-operative pain is also associated with late and chronic post~     thoracotomy pain syndromes which can be debilitating.~      Pain following thoracic surgery is different to the standard surgical incision pain and is~     due to intercostal nerve damage, compression or traction injury to the nerve. This occurs~     with the incision, rib retraction, and is compounded by the on-going need for respiratory~     effort. The approach to managing this pain is multi-modal analgesia. The standard regimen~     stretches from preemptive analgesia and preoperative placement of thoracic epidurals to~     post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non~     steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as~     anti-convulsants like pregabalin. However, opioid use has well-known side effects including~     central nervous system (CNS) and respiratory depression which unfortunately delay mobility~     and recovery. This has motivated opioid-sparing strategies.~      The investigators study aims to assess whether the addition of perineural dexamethasone (a~     steroid) to the current practice of local anaesthetic wound catheters increases the efficacy~     and duration of analgesia provided.~   "
9229|NCT02936414|"~     The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction~     hypothesis for schizophrenia has attracted increasing attention of the researchers,~     substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β,~     IL-6, TNF-α markedly elevated in patients with schizophrenia which may be particularly~     relevant for the cognitive impairment and metabolic disturbance of schizophrenia. In recent~     years, it has been demonstrated the beneficial effects of berberine on regulating lipid and~     glucose metabolism, reducing the proinflammatory status and improving cognition. As the~     investigators known, the report of berberine being used in schizophrenia is rare. This~     protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers,~     lipid and glucose metabolism, cognition in patients with schizophrenia.~   "
9230|NCT02936401|"~     The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction~     (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among~     patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and~     have maximized treatment options.~   "
9231|NCT02936388|"~     Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver~     metastases in patients with advanced uveal melanoma with respect to progression-free~     survival and exploratory comparison of secondary endpoints regarding application, activity,~     adverse effects and impact on quality of life in a randomized study design.~   "
9232|NCT02936375|"~     This study is a 52-week, randomized, open, active-controlled trial of patients with active~     diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic~     agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed~     with azathioprine, both combined with steroids.~   "
9233|NCT02936362|"~     Bread is the most common grain product in the world, with consumption surpassing 3 billion~     individuals per year. Sourdough whole-grain bread is considered a healthy alternative to~     white, refined-wheat bread.~      This cross-over study will test the effect of consumption of sourdough bread compared to~     white bread following a short dietary intervention period (one week) on multiple clinical~     parameters and gut microbiota.~   "
9234|NCT02936349|"~     Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after~     embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt~     grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs~     on chest CT and their amenability to embolization. This study's purpose is to evaluate~     whether TTCE shunt grade can also accurately predict PAVM size and amenability to treatment~     in patients who are post-embolization.~   "
9235|NCT02936336|"~     Osteoporosis is a serious global health problem, second only to cardiovascular disease.~     Osteoporosis is the most common metabolic bone disease in the elderly population,~     characterized by loss of bone mineral density (BMD) and continuous destruction of bone~     microstructure, especially in postmenopausal women. It gives rise to bone fragility and~     fracture risk. Moreover, as people grow older, falls frequently occur with high severity,~     and nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic~     fractures increase mortality, morbidity, chronic pain, and the cost of social care and it~     decreases the quality of life. Here, investigators plan to perform different exercise~     interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older~     adults to evaluate whether exercise intervention could improve the bone mineral density,~     physical fitness, muscle strength or quality of life.~   "
9236|NCT02936323|"~     Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in~     patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or~     other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma~     of the lung.~   "
9237|NCT02936310|"~     The primary objective of this proposed one-year (January 01, 2017 to December 31,2017)~     project is to assess whether a mindfulness based intervention('Mindful Living With Stress')~     will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress.~     Based on the efficacy of previous studies in stress reduction, it is hypothesized that~     'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction~     program in China.~   "
9238|NCT02936297|"~     Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence~     of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and~     relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy.~     The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or~     associated histopathologic findings. In this prospective, randomized controlled trail, we~     are investigating the utility of patient reported symptom questionnaires, as well as stool~     gluten and urine quantification tools in patients with NCGS and healthy controls.~   "
9239|NCT02936284|"~     This study evaluates the effect of a music enhancement program to strengthen the motivation~     to engage in music related behaviors rather than eating in infants who are high in~     motivation to eat. Half the participants will participate in a Music Together Program, while~     the other half will participate in a Play Date control. For both groups, participants will~     attend 34 weekly sessions for one year, and 12 monthly sessions the next year, in 4 cohorts.~   "
9240|NCT02936271|"~     The purpose of this study is to evaluate the effectiveness of Vasculera in reducing post~     procedural pain, bruising and edema in the post procedure period for patients diagnosed with~     C2-C5 disease requiring an intervention(s).~      The hypothesis is that Vasculera will reduce post procedural pain, bruising and edema for~     patients requiring an intervention.~      This will be a randomized, double-blind, placebo-controlled study. Vasculera is a specially~     formulated prescription medical food product for the clinical dietary management of the~     metabolic processes of chronic venous insufficiency. Vasculera has limited side effects,~     please see the product insert.~      A total of 110 patients will be enrolled into this study. Patients will be randomized to~     receive Vasculera (Study Product) or placebo. Study Product or placebo will be prescribed as~     one (1) tablet twice a day.~   "
9241|NCT02936258|"~     The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard~     of care systematic TRUS guided biopsy in the detection of clinically significant and~     clinically insignificant prostate cancer in men without prior biopsy. The implication of~     this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the~     standard of care in the diagnosis of prostate cancer.~   "
9242|NCT02936245|"~     Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over~     the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and~     moderate forms, has not shown better results than conservative treatment in the long term,~     and criteria for the indication and the timing of the operation have not been established.~     In order to get some more reliable data, a long-term follow up observational study will be~     started to confirm the effects of long term for conservative treatment.~   "
9243|NCT02936232|"~     The aim of this study is to construct multi-center sepsis registry that can be used for data~     warehousing and clinical research.~   "
9244|NCT02936219|"~     In this Austrian observational study preterm infants born with a birth weight <1500 g and a~     gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants~     will be stratified according their feeding regimen (breast, formula and combined feeding)~     and their introduction of solid foods (early complementary feeding group: <17th week of life~     corrected for prematurity, late complementary feeding group: ≥17th week of life corrected~     for prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6~     weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity.~   "
9245|NCT02936206|"~     The purpose of this study is to microscopically examine breast cancer cells of~     pre-menopausal women before and after exposure to one of the two commonly used breast cancer~     drugs, tamoxifen or fulvestrant.~   "
9246|NCT02936193|"~     The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for~     the treatment of early gastric cancer (EGC) remain controversial. The investigators~     conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy~     with D2 lymph node dissections for EGC.~   "
9276|NCT02935803|"~     An increasing number of specific procedures have been described for the surgical repair of~     pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The~     investigators introduced an alternative operative method for POP-Q II-III repair and~     anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral~     tissues at the level of mid-urethra. The efficacy and short- and long-term complication~     profile, of this new surgical technique as compared with those of non-modified TVM.~   "
9247|NCT02936180|"~     Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of~     death in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of~     both seasonal influenza and serious influenza-related illness (IRI) are increased. Despite~     being a high priority group targeted for vaccination, the diagnosis of RA and other~     patient-specific factors (i.e. older age, treatment, current smoking) are linked to impaired~     vaccination responses.~      Thus the burden of influenza among people with RA is disproportionally high, and~     interventions to improve responses to influenza vaccination are urgently needed. Strategies~     to optimize protection in another vulnerable group, the elderly, include the use of~     quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent,~     inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety~     profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in~     adults ≥65 years of age. Whether or not analogous strategies to improve responses to~     influenza vaccine will enhance protection in people with RA is unknown. The investigators~     hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection~     (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine.~     The investigators propose to conduct a stratified, randomized, modified double blind,~     active-controlled trial to assess immune responses to two commercial influenza vaccines~     containing different antigen doses in individuals with RA.~   "
9248|NCT02936167|"~     In children fluids are supplemented during surgery to provide volume, to maintain blood~     glucose levels, electrolyte balance and to meet the ongoing fluid losses during surgery.~     Fluid replacement during surgery since decades has been based on the Holliday and Segar~     method.These authors proposed that water maintenance in children includes: 100 millilitre~     (ml)/100 kilocalorie (kcal) for the first 10 kg of body weight, 50mL/100 kcal for 11-20 kg~     and 20mL/100 kcal for every kilogram of body weight above 20 kg. The maintenance electrolyte~     requirements of 3 mEq/100 kcal for sodium and 2 mEq/100 kcal for potassium per day, were~     based upon the electrolyte composition of breast and cow's milk. Based on these~     recommendations hypotonic fluid (0.45% saline) was considered as the ideal fluid for~     maintenance in children undergoing surgery.~      Since the past many years there have been many documented cases of hyponatremia after~     administration of hypotonic fluids with potential for serious neurological injury in this~     group of patients.The use of Holliday and Segar's formula to calculate the maintenance fluid~     regimen in postoperative children leads to an overestimation of the volume of fluid needed,~     as there is a low urine output in this period. The postoperative period is at risk for~     non-osmotic secretion of anti-diuretic hormone (ADH), which reduces the ability of kidney to~     excrete free water and carries risk for development of hyponatraemia.Authors in favour of~     hypotonic solutions feel that hyponatremia results from excessive volume of fluid and~     isotonic solutions have risk of hypernatremia, interstitial fluid overload, excessive sodium~     excretion, and hyperchloremic metabolic acidosis.~      Based on the increased incidence of hyponatremia in children undergoing surgery, the~     paediatric anaesthesia societies [Society of Paediatric Anesthesia (SPA), Paediatric~     Anaesthesia Society of Great Britain and European society of Paediatric Anesthesia (ESPA)]~     put forward guidelines for the type and amount of fluid to be administered during~     surgery.Since then normal saline is the commonly used fluid during the perioperative~     period.However recent studies have shown that the use of normal saline is associated with~     development of hyperchloremic metabolic acidosis and poor outcome.~      Ringer lactate (RL) is a commonly used intravenous fluid during surgery and has been found~     to have decreased possibility of producing hyponatremia although it is a slightly hypotonic~     solution.Plasmalyte is an isotonic fluid which has been shown to maintain electrolyte~     balance and prevent hyponatremia as well as hyperchloremic acidosis in adult~     population.However plasmalyte has been less frequently used in paediatric~     population.Therefore this study is planned with the aim of comparing intravenous fluids,~     ringer lactate and plasmalyte in the perioperative period regarding the incidence of~     hyponatremia produced by these solutions, their effect on electrolytes and blood gases in~     children undergoing elective surgery.~   "
9249|NCT02936154|"~     The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of~     PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.~   "
9250|NCT02936141|"~     The aim of this project is to describe the mental health status of the homeless people in~     Maputo and Matola utilising standardised clinical and socio-demographic assessments.~     Simultaneously; the study aims to determine the influence of a psychosocial intervention in~     patients with apparent signs of mental illness, aiming at his/her family reintegration; This~     study is conducted hypothesizing that the familial reintegration after intervention would be~     the same across patients with different mental disorders.~   "
9251|NCT02936128|"~     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active~     Comparator in patients with chronic venous leg ulcers.~   "
9252|NCT02936115|"~     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active~     Comparator in patients with chronic diabetic foot ulcers.~   "
9253|NCT02936102|"~     The purpose of this first-in-human study of FAZ053 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053~     administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult~     patients with advanced solid tumors.~      By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors,~     Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting~     in activation of an antitumor immune response by activating effector T-cells and inhibiting~     regulatory T-cells.~      This study has been designed as a Phase I, open-label, multi-center study with a dose~     escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose~     expansion part of FAZ053 as single agent and in combination with PDR001.~      FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as~     every 6 weeks may be evaluated in parallel.~      A patient may continue treatment with FAZ053 single agent or in combination with PDR001~     until the patient experiences unacceptable toxicity, confirmed disease progression per~     immune related Response Criteria and/or treatment is discontinued at the discretion of the~     investigator or the patient.~   "
9254|NCT02936089|"~     Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease~     entailing different prognoses. There were significant differences in the therapeutic effect~     between different subgroups of AE AML. Therefore, risk stratification-directed therapy is~     very necessary for AE AML.~   "
9255|NCT02936076|"~     The purpose of this study is to examine the psychological benefits of chronic exercise as~     well as the effects of exercise training on eating behaviors and stress-induced overeating~     in overweight and obese women. Participants will be randomized to an 12-week exercise~     condition or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and~     12 weeks and will include answering surveys in real-time using smartphones, several~     assessments of eating behaviors and dietary intake, and questionnaire measures of factors~     which could mediate the relationship between exercise and eating. Participants will be~     compensated for completing assessments and for adherence to the exercise protocol.~   "
9277|NCT02935790|"~     Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose~     (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab and~     nivolumab in patients with unresectable Stage III/Stage IV melanoma.~   "
13677|NCT02878252|"~     The purpose of this study to determine the proportion and clinical characteristics of COPD~     patients with asthma symptoms (ACOS) and describe current practices in diagnosis and~     management in Viet Nam and Taiwan.~   "
9256|NCT02936063|"~     When patients undergo neck dissection surgeries, the current standard of care is to close~     the skin layer with either metal staples, which are removed a few days post-operatively, or~     with sutures, which can be absorbable or removed. To date, there is no conclusive data in~     the literature that definitively suggests one method is better than the other, with regard~     to wound complications or mature scar cosmesis. Currently, skin closure method is chosen by~     each individual surgeon, and is based on personal preference, factoring in evaluation of the~     wound. The goal of the study is to compare the two methods of skin closure, and the measured~     outcomes the investigators will be looking at are patient satisfaction, wound complications,~     and mature scar cosmesis. The investigators will be randomizing patients undergoing head and~     neck surgery to receive either staples or subcuticular sutures, and giving them surveys at~     their post-operative clinic visits to evaluate the outcomes, to determine if patients~     perceive one method to be superior to the other.~   "
9257|NCT02936050|"~     The cost related to management of heart failure is significant, both with respect to the~     financial costs and the suffer of patients. Still as much as 50% of heart failure patients~     are readmitted within 6 months after hospitalization for decompensated heart failure.~      Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF~     patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In~     heart failure patients the use of ultrasound as a tool for assessing volume status and~     guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility~     and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac~     function indices and assess volume status in outpatient heart failure clinics combined with~     a telemedicine approach for near real-time interpretation of the recordings by a~     cardiologist specialized in echocardiography and heart failure at a remote location.~   "
9258|NCT02936037|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     disability of patients suffering from progressive multiple sclerosis and especially those~     with gait impairment.~   "
9259|NCT02936024|"~     Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and~     it is commonly managed by surgical intervention. Patients with intra-abdominal or non~     palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy,~     a common surgical technique to bring undescended testes down into the scrotum. Evidence in~     the medical literature to support the superiority of either one stage or two stage~     gubernaculum sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this~     study focuses on the effects of one stage versus two stage GSLO on a patient important~     outcome: testicular atrophy.~   "
9260|NCT02936011|"~     Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total~     Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and~     re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular~     Scaffold (BVS).~   "
9261|NCT02935998|"~     1. The title of this study is a multi-center,non randomized,open-labeled,intervention~          study:the efficacy and safety of intramuscular ziprasidone for three days in patients~          with acute psychotic agitation.~        2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in~          patients with acute psychotic agitation in daily clinical practice.~        3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in~          patients with acute psychotic agitation in daily clinical practice.2.To compare the~          efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the~          different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular~          ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the~          measured based administration according to severity of symptoms.5.To compare the~          efficacy and tolerance of ziprasidone im between the monotherapy and combination with~          other antipsychotic drug in clinical practice.~        4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on~          schizophrenia. But in the foreign country, ziprasidone im also is approved to treat~          psychotic agitation, including bipolar and schizoaffective disorder. And in the~          clinical practice of China, ziprasidone im is also used to treat other patients,~          although the evidence is less. In this study, we assume ziprasidone im treat the~          psychotic agitation is effective and safe.~        5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background~          and the hypothesis：The researches of ziprasidone mesylate injection in our country are~          more concentrated in schizophrenia at present, while in foreign countries ziprasidone~          is approved for psychotic agitation, including mania etc. It's also used for substance~          abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone~          mesylate injection is effective in the treatment of acute agitation, and it's well~          tolerated.~   "
9262|NCT02935985|"~     The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h)~     spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC,~     glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI,~     hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to~     determine their input for early risk stratification and prognosis.~   "
9263|NCT02935972|"~     Prostate biopsy under transrectal ultrasound (TRUS) guidance is considered the procedure of~     choice for diagnosing prostate cancer. And as in any other diagnostic biopsy procedures;~     patients perceive anxiety before, during and after biopsy and ultrasound guided prostate~     biopsy is not an exclusion.~      TRUS guided prostatic biopsies are mainly performed in an outpatient clinic, men undergoing~     transrectal prostate biopsy experience considerable psychological stress. It may be~     attributable to the fear of the potential diagnosis of cancer, the anal route of~     penetration, the fact that the subject organ examined is part of the sexual system and the~     anticipated pain and as a matter of fact the issues of discomfort and pain perceived~     throughout the procedure referred to the negative impact of the whole procedure, that is~     probe insertion and biopsy punctures.~      Thus it is essential to employ a simple method that can liberate the patient from pain~     during prostate biopsy. Some studies recommend sedation , others recommend intra-rectal~     lidocaine gel and others periprostatic nerve block while others recommend Nitrous oxide~     inhalation as an effective method of analgesia for the procedural related pain or discomfort~     of prostate biopsy. The employment of analgesics, sedation and/or narcotic medication may~     alleviate much of the discomfort associated with transrectal prostate biopsy, such treatment~     may be associated with additional risks. Furthermore, when systemic medication is~     administered, patients require conscious sedation monitoring during and after the procedure,~     which may be inconvenient and relatively expensive in addition to their unsuitability to be~     performed on outpatient clinic basis. Therefore, a simple form of anesthesia is desirable.~      Although a wide variety of anesthetic techniques are available for transrectal~     ultrasound-guided prostate biopsy, including rectal administration of lidocaine gel,~     periprostatic nerve blocks, intravenous propofol, and narcotic intramuscular premedication,~     these methods may not optimally prevent or relieve pain.~   "
9264|NCT02935959|"~     Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized~     midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children~     undergo bone marrow aspirate and biopsy.~   "
9273|NCT02935842|"~     Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the~     literature reports that PD patients, who have not undergone deep brain stimulation (DBS),~     have deficits regarding voice quality (e.g. loudness and intelligibility of their voice),~     while PD patients who have undergone DBS suffer from deficits in word retrieval and speech~     apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits~     observed in PD-DBS patients are yet to be developed and evaluated.~      Therefore, this study investigates the short-and longterm effectiveness of specific and~     intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared~     to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training~     (rBMT)) as well as to a 'no-therapy' condition.~   "
9265|NCT02935946|"~     A previous study revealed that dysphagia preterm infants show statistically significant~     improvements in their swallowing mechanism when fed cold liquid barium when compared to room~     temperature liquid barium. The previous study was the first to identify these positive~     effects, although, only assessed 5 cold liquid swallows, immediately after the room~     temperature condition. This limited data set restricts the efficacy and safety of using cold~     liquids in clinical practice, emphasizing the need for further information. The present~     study aims to objectively assess the influence of cold liquid on the pharyngeal swallow~     mechanism in preterm infants with dysphagia after 10 minutes of a cold liquid feeding. The~     investigators will utilize videofluoroscopic swallow studies (VFSS) to analyze the frequency~     and severity of pharyngeal swallowing deficits during room temperature swallows and compare~     it to cold liquid swallows at various time points within a 10 minute feeding. Safety~     measures will also be obtained, such as participant axillary body temperature and gastric~     content temperature, to identify indicators for the development of cold stress.~   "
9266|NCT02935933|"~     Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could~     improve the analgesic effect and thus reduce postoperative morphine consumption and~     development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients~     undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast~     conservation surgery with axillary lymph node dissection.~   "
9267|NCT02935920|"~     Background:~      In February 2015 the Danish Health and Medicines Authority published new clinical guidelines~     describing how cancer patients should be followed. It is recommended that patients receiving~     specific oncological treatment such as endocrine therapy be followed at the department of~     oncology responsible for the treatment and providing the medication. There is no evidence~     that routine examinations improve overall survival after breast cancer. Mammography is the~     only specific examination to be offered to asymptomatic women after treatment for breast~     cancer~      Aims of the study:~      Our hypothesis is that individualized follow-up with the introduction of Patient Reported~     Outcome (PRO) data will help postmenopausal women regain control of their health related~     self-care and encourage them to a larger extent to take part in their follow-up after cancer~     treatment. We believe this will improve the health related quality of life and increase the~     positive experience of the follow-up program.~      Design:~      Patients are randomly assigned to the department's standard control program or an~     individualized solution in the context of shared decision making. PRO data will be used to~     evaluate the patient's need for consultations.~      Primary outcome:~      Evaluation of the experience and feasibility of PRO data in connection with individualized~     follow-up of postmenopausal women with breast cancer. Systematically applying PRO data we~     will uncover patient needs, empower the patients to take part in shared decision making, and~     improve the current follow-up in the sense of a more patient-centered care and tailored~     follow-up.~   "
9268|NCT02935907|"~     APG-115 is a novel, orally active small-molecule mouse double minute 2 homolog (MDM2)~     inhibitor. Mechanistically, APG-115 increases p53 and p21 overexpression, activates p53 -~     mediated apoptosis in tumor cells retaining wild-type p53. APG-115 has shown strong dose-~     and schedule-dependent antitumor activities in multiple human cancer xenograft and a patient~     derived xenograft (PDX) models. The preclinical data generated from APG-115 suggest that it~     may have a broad therapeutic potential for the treatment of human cancer as a single agent~     and in combination with other classes of anticancer drugs. APG-115 is intended for the~     treatment of patients with advanced solid tumors and lymphomas. Upon completion of the Phase~     1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting~     toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will~     be implemented accordingly.~   "
9269|NCT02935894|"~     The purpose of this study is to see what the differences are in sweat (amount and small~     molecule content) collected from different sites of the body and by different methods of~     sweat stimulation. Additionally, the investigators want to know whether the amount and small~     molecule content of the sweat is the same in an individual over time, and the same across~     individuals at a given time. Finally, the investigators want to know how consumption of~     over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory~     mediator content of sweat and how that compares to blood. This information will help to~     better understand the composition and behavior of sweat and assess its potential utility as~     a routine clinical tool in skin research.~   "
9270|NCT02935881|"~     Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the~     quality of life of patients. It may also lead to several complications like peptic~     strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the~     esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 %~     of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies~     have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the~     Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The~     investigators propose to perform a sham-controlled randomized study to evaluate the~     influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of~     refractory GERD.~   "
9271|NCT02935868|"~     Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence,~     extension and severity. Periodontal disease is considered the sixth complication of~     diabetes. There is a global epidemic of diabetes, including an increase of incidence of type~     1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate~     the periodontal and salivary condition of a sample of patients with type 1 diabetes of a~     brazillian city.~   "
9272|NCT02935855|"~     Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of~     non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and~     with vitamin K oral anticoagulants.~   "
9274|NCT02935829|"~     This study investigated any potential associations between two preloads offered as snacks~     and postprandial glycemic response, subjective and objective appetite and energy intake in~     healthy, normal-weight adults.~   "
9275|NCT02935816|"~     The investigator prospectively compare diagnostic concordance of whole body~     multi--‐parametric Magnetic Resonance Imaging (MRI) with current conventional~     multi--‐modality reference standard imaging (CT scan, isotope bone scan +/--‐ PET--‐CT scan)~     for staging of prostate cancer patients with biochemical relapse following external beam~     radiotherapy or brachytherapy of locally advanced prostate cancer.~   "
9278|NCT02935777|"~     The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a~     two week intervention after a pre-intervention registration and preparation period.~      This study explores whether acute supplementation with pomegranate extract can modulate~     indicators of cognitive function and mood in healthy adults. Changes in physiological and~     biochemical markers are also investigated.~   "
9279|NCT02935764|"~     This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan~     monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.~   "
9280|NCT02935751|"~     The ADIOS study is a prospective, observational study will evaluate one hundred and thirty~     (130) patients with non-valvular atrial fibrillation who are currently receiving treatment~     with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who~     require an elective major surgical or invasive procedure will be included in the study. The~     purpose of the study is to evaluate the efficacy of the recommended pre-procedure washout~     period of 48 hours.~   "
9281|NCT02935738|"~     Corticosteroids have been indicated to treat men with ASAs. Although many studies have~     confirmed the clinical therapeutic significance of corticosteroids in the treatment of men~     with ASAs, other studies have not found a therapeutic significance for corticosteroids in~     the treatment of men with ASAs. Moreover, although some reports have shown high~     fertilization and conception rates in couples when husbands did not have ASAs, other reports~     have shown that ASAs do not have a negative effect on fertilization and conception rates.~     These contradictory results have left the therapeutic effect of corticosteroids in men with~     ASA in continuing controversy. This controversy is also extended to include the usefulness~     of assisted reproductive technology (ART) in the treatment of patients with ASAs. In this~     regard, although some studies have shown that the pregnancy rate following in vitro~     fertilization (IVF) or intracellular sperm injection (ICSI) were similar in men with or~     without ASA or did not associate with ASA, others reported the superiority of ICSI over IVF~     and intrauterine insemination over natural intercourse in men with ASAs. It is possible that~     some patients with ASAs also have an additional problem(s) related to sperm binding to the~     oolemma and fusion into the ovum as well as sperm head decondensation. The latter condition~     may negatively influence or mask the clinical significance of corticosteroids on pregnancy~     rates in patients with ASAs. Some patients might not have benefited from corticosteroids and~     conventional IVF treatments due to the impaired sperm fusogenic capacity in addition to~     ASAs. Human sperm penetration assay (SPA), of the hamster oocyte free from zona pellucida,~     is a sensitive tool that can address such potential impairment of sperm binding with the~     oolemma and fusion into the oocyte as well as sperm head decondensation. Males with poor SPA~     results benefit from ICSI whereas those with good SPA results can still benefit from~     conventional IVF.~      The present study was therefore conducted to address the therapeutic usefulness of a~     corticosteroid named prednisolone in the treatment of immunologically infertile men~     undergoing IVF or ICSI determined by SPA.~   "
9282|NCT02935725|"~     A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the~     pharmacoMRI Effects of AUT00206 in Healthy Male Participants~   "
9283|NCT02935712|"~     This study will be a phase I, first time in human (FiH), randomized, single-blind,~     placebo-controlled, SAD study in male patients with T2DM, performed at a single study~     center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged~     18 to 65 years will be included.~   "
9284|NCT02935699|"~     This will be a multicenter, parallel group, randomized, double-blind, active controlled,~     Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine~     injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 256 patients (1:1~     ratio) with acute urticaria requiring treatment in Emergency Departments, hospitals, Urgent~     Care Centers, Allergy Clinics, and etc.~   "
9285|NCT02935686|"~     The primary purpose of this study is to assess safety/tolerability of the different vaccine~     regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different~     vaccine regimens.~   "
9286|NCT02935673|"~     The purpose of this study is to determine in adults who are hospitalized with respiratory~     syncytial virus (RSV) infection the dose response relationship of multiple regimens of~     ALS-008176 on antiviral activity based on nasal RSV shedding using quantitative real-time~     reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.~   "
9287|NCT02935660|"~     Mult-center study to evaluate the safety and efficacy of an investigational version of the~     Cutera enlighten laser that offers multiple wavelengths for tattoo removal~   "
9288|NCT02935647|"~     This study is designed to determine if the antidepressant effects of deep anesthesia via~     propofol are related to EEG burst suppression.~   "
9289|NCT02935634|"~     The purpose of this study is to determine whether Nivolumab in combination with other~     therapies is more effective than Nivolumab in combination with Ipilimumab in treating~     patients/subjects with advanced gastric cancer.~   "
9290|NCT02935621|"~     The central aim of this proposed study is to test a multimodal, mindfulness-oriented~     intervention designed to disrupt the risk chain leading to prescription opioid dose~     escalation, opioid misuse and opioid addiction, which are mounting threats to active duty~     service members and Veterans with chronic pain conditions, who may develop disordered opioid~     use as a consequence of long-term opioid pharmacotherapy.~   "
9291|NCT02935608|"~     The primary objective of the study is to evaluate the efficacy of two dose regimens of~     BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR).~     Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on~     additional neuropathic pain measures and assessments of low back pain, disability, and~     quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074~     and To characterize the pharmacokinetics (PK) of BIIB074 in this population.~   "
9292|NCT02935595|"~     The present proposal aims to combine state-of-the-art integrated transcranial brain~     stimulation, electroencephalographic recording techniques with genetics and computational~     modeling to unveil the mechanisms underlying a fundamental cortical network process -~     synchronization of neuronal activity in the gamma band (30-80 Hz) - and the sources of its~     intersubject variability. By measuring the entrainment of prefrontal cortex produced by weak~     oscillatory currents, the study team will provide a new non-invasive strategy to derive~     robust estimates of the cortical ability to support gamma oscillations, critically~     overcoming limitations associated with current approaches and allowing measures solely~     dependent on intrinsic regional cortico-thalamic properties. Consistent with molecular~     evidence and the investigators biophysical models of gamma oscillations, the study team~     expects that such unambiguous measurement of cortical capabilities will straightforwardly~     map onto key genetic underpinnings related to the dopamine and neuregulin signaling~     pathways. These computational models will be used to offer critical mechanistic insights~     linking genetic variations to variability in emergent circuit-level activity in the form of~     cortical gamma oscillations.~   "
9293|NCT02935582|"~     Multinational real-life study of current psoriasis treatment strategies, topical treatment~     patterns and treatment outcomes of these treatments, including the newly introduced~     calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar®~     (calcipotriol/betamethasone dipropionate).~   "
9296|NCT02935543|"~     This is a single center, single arm, open-label phase 2 study to determine the efficacy of~     autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and~     4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART19 cells) in adults with~     minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic~     leukemia.~   "
9297|NCT02935530|"~     Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality~     in women undergoing surgery for gynecologic malignancies. Although the benefit of~     thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic~     cancers has been well documented around the world, the evidence for Chinese women is rare.~     The investigators designed this prospective and randomized study to assess the benefit of~     pharmacologic prophylaxis for patients received surgical treatment for gynecologic~     malignancies in China.~   "
9298|NCT02935517|"~     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of~     AGTC-402, administered to one eye by subretinal injection in individuals with achromatopsia~     caused by mutations in the CNGA3 gene. The primary study endpoint will be safety and the~     secondary study endpoint will be efficacy.~   "
9299|NCT02935504|"~     The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that~     aims to improve women's access to and participation in perinatal depression treatment and~     thereby improve depression outcomes~   "
9300|NCT02935491|"~     Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an~     alternative to conventional surgery for aortic stenosis cure. Despite a high rate of~     procedural success, some patients do not benefit from the procedure. The investigators~     hypothesis is that aortic stiffness may be of major prognostic significance after stenosis~     relief.~      The aim of this study is to test the prognostic impact of aortic stiffness estimated by the~     volume of calcifications of the thoracic aorta on the CT-scan performed systematically~     before the procedure. This prognostic value will be assessed in 4 independent cohorts issued~     from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).~   "
9301|NCT02935478|"~     Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a~     grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not~     candidates for liver transplantation, depriving them of the best option for cure from HCC.~      Recent studies have shown that blocking blood vessels to a particular portion of the stomach~     (bariatric or left gastric artery embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to~     determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who~     are not transplant candidates due to morbid obesity, leads to clinically significant weight~     loss with eligibility for liver transplantation.~   "
9302|NCT02935465|"~     The overarching aim of this project is to conduct a randomized controlled study to determine~     whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can~     improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought~     to be governed by the endogenous opioid system among opioid-treated, chronic,~     non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and~     opioid use.~   "
9303|NCT02935452|"~     The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people~     to find and join social activities in their own neighbourhoods.~      Evidence has shown that people with more social support have increased ability to manage~     long term conditions and ill health.~      Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day;~     this is both tiring and makes its difficult to socialise as they did prior to having their~     condition. COPD can be managed with medicines, and exercise, but will never be cured, so it~     is considered a 'long term condition.'~      This study plans to use a social mapping tool (GENIE) with COPD patients that are already~     part of the community service. The aim of the study is to increase opportunities to~     socialise and get day to day support outside of the health service.~      Patients will be offered either the tool, or usual care.~      If the study is successful then use of health care may reduce in the COPD patients already~     using the COPD service.~   "
9304|NCT02935439|"~     The purpose of this research study is to learn about the use of a cell phone for monitoring~     patients with heart failure. Participants will be asked questions about their heart failure~     daily and participants will need to answer them. The investigator will try to assess if the~     questions are easily understood by the participants. The investigator will also assess if~     the phone-based system for monitoring is easy to use by the participants. The investigator~     will also assess if the daily questions and interactions increase the self-efficacy,~     knowledge, and quality of life of participants related to their heart failure.~   "
9305|NCT02935426|"~     Cyanoacrylate tissue adhesives have been successfully used for wound closure. The purpose of~     this clinical trial is to compare cyanoacrylate tissue adhesives to polytetrafluoroethylene~     (PTFE) sutures in the donor site of connective tissue grafts. Two groups of volunteers will~     randomly assigned to one of the two study groups. The wound closure at the palatal donor~     area will be achieved with polytetrafluoroethylene (PTFE) sutures in one group and with high~     viscosity cyanoacrylate tissue adhesives on the other group. The surgical procedure will be~     performed by one of three calibrated periodontics residents. Data will be collected at~     baseline-day of the surgery and in one week post-operatively. The primary outcome is~     patient's discomfort from the donor site during the first week after the surgery. Secondary~     outcomes is the time required for suture placement or cyanoacrylate application, patient's~     pain from donor and recipient site one week post-operatively, painkillers intake, presence~     or absence of inflammation and modified EHI early-wound healing index.~   "
9306|NCT02935413|"~     The purpose of this Study is to determine whether non-invasive transcranial direct current~     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual~     Cortex.~   "
9307|NCT02935400|"~     The long term objective of the research is to identify new biomarkers of disease activity in~     the human acute porphyrias. This pilot study is intended to provide pilot and feasibility~     data needed to plan larger and more definitive future studies.~   "
9370|NCT02934581|"~     A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were~     newly admitted to the medical intensive care units and turned out to be diagnosed as Obesity~     hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence,~     predictive factors, and outcomes of OHS in these critically ill patients.~   "
9308|NCT02935387|"~     Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi)~     and methotrexate (MTX) often express their wish to stop MTX treatment because of side~     effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission~     with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in~     maintaining sustained remission and reaching drug free remission as compared to~     discontinuation of TNFi prior to MTX.~      Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more~     efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug~     free remission.~      Study design: multicenter, open label clinical trial in very early RA patients. Remission~     will be induced by an open label treat-to-target (T2T) remission induction protocol in~     clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in~     remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained~     remission on MTX/GOL (DAS28<2.6 with max 4 swollen joints of the 44 swollen joint count~     (SJC) at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first,~     then GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission~     (phase II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained~     remission will be investigated (phase III).~      Study population: RA patients fulfilling 2010 American College of Rheumatology~     (ACR)/EUropean League Against Rheumatism (EULAR) criteria for RA, with symptom duration <12~     months; naïve for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2.~      Intervention: Patients in sustained remission (defined as DAS28<2.6 with max 4 swollen~     joints of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase~     I (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper~     medication as follows:~        -  Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper~          and stop MTX during 24 weeks~        -  Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper~          and stop GOL during 24 weeks The primary end point is the proportion of patients in~          sustained remission at week 24 after start of tapering of either MTX or GOL first. The~          main secondary end point is the proportion of patients in drug-free sustained~          remission, at week 48 after start of tapering.~   "
9309|NCT02935374|"~     This is a randomized, controlled trial studying the effects of various antimicrobial~     treatments on the intestinal microbiome of small children. The participating children with~     acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without~     antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they~     will be monitored as a separate group. The main outcomes of this trial are the changes in~     the intestinal microbiome after the treatment.~   "
9310|NCT02935361|"~     This phase I/II trial studies the side effects and best dose of guadecitabine when given~     together with atezolizumab and to see how well they work in treating patients with~     myelodysplastic syndrome or chronic myelomonocytic leukemia that has spread to other places~     in the body and has come back or does not respond to treatment. Guadecitabine may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as atezolizumab, may interfere with the ability of cancer cells to grow and~     spread. Giving guadecitabine and atezolizumab may work better in treating patients with~     myelodysplastic syndrome or chronic myelomonocytic leukemia.~   "
9311|NCT02935348|"~     Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations~     including a separate PET and MRI scans during their treatment.~      Investigators want to investigate if a combined PET-MRI scan could give the same~     information.~      Children who join our study will have an extra scan twice during their treatment~   "
9312|NCT02935335|"~     AME is a non-interventional, prospective, longitudinal and multicenter study. This study~     aims to measure the relationship between antimüllerian hormone serum level (AMH), as~     measured by a single fully automated assay (Elecsys®) and the initial dose of Menopur®~     Highly Purified-human Menopausal Gonadotrophin (HP-hMG) 600 IU/mL prescribed for infertile~     women undergoing their first In Vitro Fertilization (IVF)/Intra Cytoplasmic Sperm Injection~     (ICSI) cycle in the current practice.~   "
9313|NCT02935322|"~     The aim of the present study was to study if there are interactions and reduced clinical~     effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.~   "
9314|NCT02935309|"~     This research study is designed to see if Capecitabine and Lenvatinib in combination with~     external radiation therapy are effective in treating locally advanced rectal adenocarcinoma~     in patients who have not yet had surgery, and what the best dosage is.~   "
9315|NCT02935296|"~     The purpose of this study is to determine the feasibility of a future trial that will assess~     whether an integrated intervention combining psychosocial counseling and supported referrals~     for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for~     HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected~     injection partners, as compared to routine care dictated by national guidelines for~     HIV-infected PWID.~   "
9316|NCT02935283|"~     In proximal urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency~     (OTCD), hyperammonemia (HA) causes increased brain glutamine (Gln) which perturbation is~     thought to be at the core of the neurological injury. In contrast, in distal UCD such as~     citrullinemia (argininosuccinate synthetase deficiency; (ASSD) and argininosuccinic aciduria~     (argininosuccinate lyase deficiency); (ASLD) cognitive impairment and neuropsychiatric~     disease are common even in the absence of acute HA. As a consequence, both citrulline and~     argininosuccinate (ASA) or their metabolic products have been implicated as neurotoxic. In~     this project the investigators will use state-of- the-art neuroimaging and~     neuropsychological methods to investigate whether patients with OTCD have chronically~     elevated brain Gln and reduced myo-inositol (mI) levels that correlate with regional brain~     structural abnormalities and neurocognitive dysfunction. The researchers will further~     investigate whether during an acute episode of HA elevated brain Gln and decreased mI levels~     correlate with the magnitude of cytotoxic edema and whether a Gln/mI ratio threshold can be~     identified at which the cytotoxic edema is followed by cell loss. Finally, the researchers~     will investigate whether regions of brain damage in ASSD and/or ASLD are distinct from those~     in OTCD and compare brain Gln levels in ASSD and ASLD in the absence of HA to those in OTCD.~     The investigators will also seek to determine if brain citrulline and ASA can be identified~     in the brains of patients with distal UCD and whether they correlate with brain~     abnormalities seen in MRI and neuropsychological testing. This project will elucidate the~     chronology of brain pathology both in acute hyperammonemia and chronic UCD and whether,~     proximal and distal UCD differ in their pathophysiology of brain damage.~   "
9317|NCT02935270|"~     The purpose of this study is to examine measurement of unilateral neglect post stroke.~     Although a number of clinical assessments are used to measure neglect, it is unclear whether~     items from some of the most commonly used assessments are able to effectively and~     comprehensively measure neglect. This study will determine whether these assessments measure~     different aspects of neglect and whether items from various neglect assessments can be~     combined to more effectively measure neglect.~   "
9368|NCT02934607|"~     This study will be conducted to establish the relative bioavailability of budesonide and~     formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without~     a spacer device.~      Administration under each condition will occur with the concomitant administration of~     activated charcoal to estimate exposure through the lung and without activated charcoal to~     estimate total systemic exposure.~   "
9318|NCT02935257|"~     This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced~     Therapy Investigational Medicinal Product (ATIMP) in adults (age 16 to 65 years) with high~     risk, relapsed/refractory CD19+ B-ALL. The ATIMP for this study is cryopreserved autologous~     patient-derived T-cells transduced with a lentiviral vector to generate the CD19CAT-41BBZ~     CAR T-cells (referred to subsequently as CD19CAR T-cells). Patients will undergo an~     unstimulated leucapheresis for the generation of the ATIMP which will take approximately 15~     days to generate. During this period, patients may receive holding chemotherapy as per~     institutional practice to maintain disease control. Patients will receive pre-conditioning~     lymphodepleting chemotherapy with cyclophosphamide 60mg/kg on Day -6 and fludarabine 30mg/m2~     administered over 3 days (Day -5 to Day -3).~      The study is designed as an intra-patient dose escalation employing a total dose range (over~     2 doses, Dose 1 and Dose 2) of between 5 x 106 CD19CAR T-cells and 1.1 x 109 CD19CAR~     T-cells. The study will evaluate ATIMP safety and efficacy and the duration of disease~     response in adults with high risk / relapsed CD19+ B-ALL.~      After completing the interventional phase of the study all patients, irrespective of whether~     they progressed or responded to treatment, will enter long term follow up until 5 years~     post-CD19CAR T-cell infusion.~   "
9319|NCT02935244|"~     ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical~     patients, which aims to determine the incidence of healthcare-associated S. aureus~     infections, particularly S. aureus surgical site infections (SSIs), across Europe and to~     assess the most important risk factors for this type of infection.~   "
9320|NCT02935231|"~     Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the~     first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not~     seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor~     place where smokers stop/linger and smoke. We aim to include a reasonably representative~     or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will~     randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous~     community trial.~      Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced~     research assistant) will be deployed for each session of intervention at a SH. Potential~     subjects will be approached using the a-foot-into-the-door method in which SC ambassador~     will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices.~     Smokers will be assessed for eligibility and informed written consent will be sought.~     Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To~     reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact~     number of the trial into subjects' mobile phones.~      Discussion: The findings will provide much needed and original evidence to support a main~     RCT on these new, proactive, simple and low-cost interventions for improving current SC~     services and policy for smokers who do not actively seek help from SC services in Hong Kong~     and elsewhere.~   "
9321|NCT02935218|"~     N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years)~     participated in a 12-week training program. To estimate the participants' impairment,~     parental stress and psychological distress were assessed before the training. After the~     training, participants and trainers were asked to provide feedback regarding the valuation~     of and the changes due to the training.~   "
9322|NCT02935205|"~     This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see~     how well they work in treating patients with prostate cancer that does not respond to~     treatment with hormones, has come back, or has spread from where it started to other places~     in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using~     enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen~     the body makes and/or blocking the use of androgen by the tumor cells.~   "
9323|NCT02935192|"~     A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent,~     split, inactivated influenza vaccine produced by Torlak.~   "
9324|NCT02935179|"~     The purpose of this project is to use white-skinned sweet potato as the main material for~     weight control for overweight and obesity, the non-communicable diseases (cardiovascular~     diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high~     quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and~     health food that to do functional study in Shih Chien University and Taipei Medical~     University. In this study, the investigators will recruit overweight and obesity subjects~     that divide into white sweet potato group (experimental group) and no intervention group~     (control group) by using randomized, parallel and open clinical study in sixty days.~   "
9325|NCT02935166|"~     Respiratory muscle weakness and fatigue are related to clinical deterioration in patients~     with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a~     key therapeutic strategy in these patients. It is necessary therefore to increase its~     dissemination on a large scale, improve patient´s adherence and optimize the control of the~     implementation of training. The aim of this project was to design a RMT device including~     light and sound incentives, digital registration application and analysis of the training~     sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity~     that could provide added value to enhance the implementation of training in patients with~     COPD. From an operational point of view, researches were organized into three packages of~     complementary work focused on the design of a new portable dual valve with electronic~     lighting and auditory incentives components. The conceptualization and design of a software~     to analyze the performance and individual continuous use of the valve, and the evaluation of~     the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training~     in adult patients with COPD were realized.~   "
9326|NCT02935153|"~     The overall purpose of this study is to explore the therapeutic effect of CD22-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Malignant B-cell Derived~     Leukemia and Lymphoma.~   "
9350|NCT02934841|"~     The investigators hypothesize that it is safe and effective to treat patients with choroidal~     neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis~     with Conbercept.~      This will be a randomized, placebo-controlled trial. 20 patients will receive three~     injections of Conbercept into the affected eye (and repeated injections if required), and 20~     patients will receive three sham injections requiring no needle stick, but making the~     patient unaware of whether or not he received active treatment.~      Outcome of the two treatment groups will be compared after one year.~   "
9327|NCT02935140|"~     Many children who are born medically fragile due to prematurity, multiple congenital~     abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require~     tracheostomy tube placement due to need of chronic respiratory support. Patients on~     tracheostomy tubes are often unable to vocalize, causing a delay in speech development and~     poor speech. To help restore normal phonation and promote language development in young~     pediatric patients with tracheostomies, speaking valves are used. Previously it was shown~     that the Passy-Muir speaking valve was safe to use during sleep in children by showing there~     were no adverse cardiopulmonary events seen. One objective measurement that was not~     evaluated was trans-tracheal pressure manometry. The purpose of this study is to continue to~     validate the safety of the Passy-Muir speaking valve while asleep, with the use of~     trans-tracheal manometry by comparing expiratory pressure manometry while the patient is~     awake and asleep.~   "
9328|NCT02935127|"~     Absorbable sutures are not generally accepted by the majority of vascular surgeons for the~     possible complications such as the breakage of the suture at the anastomoses level. Some~     experimental and clinical studies in the current literature demonstrated that the use of~     absorbable sutures may even reduce some important complications such as restenosis.~      The aim of this study is to compare absorbable and non-absorbable sutures in patients~     undergoing peripheral vascular surgery with vein bypass grafting.~   "
9329|NCT02935114|"~     Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide~     peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior~     superior teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the~     tooth sensitivity before, during and 24 hours after the procedure.~      Materials and Methods: Fifty patients will be selected for this single-blind, parallel,~     randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or~     35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes~     for two sessions with a 7-day interval. The sensitivity level will be assessed before,~     during and 24 hours after the procedure using verbal and analogic visual analogue (VAS)~     scales. Color alteration will be assessed by a bleach guide scale 7 days after each session~     and 30 days after the last session. Relative risk to sensitivity will be calculated and~     adjusted by session; while comparison of overall risk will performed by McNemar's test. Data~     on the sensitivity level for both scales will be subjected to the Mann-Whitney tests (α =~     0.05). The color change will be measured with a spectrophotometer using the CIE L * a * b *~     and the L*, a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected~     to two-way repeated measures ANOVA test to compare the two bleaching techniques at each~     evaluation time (α = 0.05).~   "
9330|NCT02935101|"~     The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency~     of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or~     heroin.~   "
9331|NCT02935088|"~     The purpose of this study is to understand routine use of FFR and alternate indices in~     clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI~     in patients presenting with either stable coronary artery disease, or in patients presenting~     with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during~     index and secondary procedures.~   "
9332|NCT02935075|"~     The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However,~     synergy among these drugs has not been well considered. The dose of drugs used as~     monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz~     is still the first line regimen of cART in developing countries. The side effects of these~     drugs are related to the concentration of drugs. Based on our previous data, we aim to~     evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence~     of the side effects while not scarifying their virological efficacy.~   "
9333|NCT02935062|"~     The aim of this study is to compare phonological and auditory aspects of children submitted~     to traditional phonological therapy, phonological therapy using a software and placebo~     therapy in children with phonological disorders.~   "
9334|NCT02935049|"~     For tough colic resection, evaluation of our practice for these lesions unresectable in~     monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy~     dissection) /ESD (submucosal dissection)~   "
9335|NCT02935036|"~     Safety and efficacy study in patients with acne vulgaris~   "
9336|NCT02935023|"~     The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT)~     treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The~     primary objective: to determine disease biochemical progression-free survival in man with~     oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive~     radiotherapy of the primary tumor. The secondary objective: to determine local control,~     overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing~     carbon ion radiotherapy~   "
9337|NCT02935010|"~     With markedly increased antibiotic resistance and unsatisfactory efficacies of common~     empiric eradication regimens in the mainland of China, tailored therapy may be the best~     choice to achieve good efficacy. This study compared the eradication rates, safety, and~     compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth~     quadruple therapy in the naive patients with Helicobacter pylori infection.~   "
9338|NCT02934997|"~     To determine the role of dysfunctional high density lipoprotein (Dys-HDL) in predicting or~     mediating progression to chronic critical illness or morbid long-term outcomes in patients~     being treated for community-acquired or hospital-acquired sepsis.~   "
9339|NCT02934984|"~     The aim of the study is to evaluate whether peripheral circulating cell-free tumor~     DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also~     planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.~   "
9340|NCT02934971|"~     The present project will develop an automated machine learning approach using multi-modality~     data (imaging, laboratory, electrocardiography and questionnaire) to increase the~     understanding and prediction of arising heart failure in patients scheduled for cardio-toxic~     chemotherapy. This algorithmus will be developed by the technical cooperation partner at~     Technion, the institut for biomedical engineering in Haifa, Israel.~   "
9351|NCT02934828|"~     The investigators research aim to explores the optimal comprehensive treatment for TNBC and~     her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant~     treatment in improvement of RFS.~   "
9341|NCT02934958|"~     We plan to study whether the impact of offering the choice of a pre-colonoscopy physician~     visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to~     usual care in a large fecal immunochemical test (FIT) mailing campaign.~      We will evaluate two study options, usual care during which patients will be required to~     have an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for~     a colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy~     visit with a gastroenterologist or PCP vs. direct referral for a colonoscopy.~      In these two options we will examine colonoscopy adherence, adequacy of triage, patient~     satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy)~     and how insurance coverage, gender, race, education or patient understanding of colon cancer~     screening message during the navigation process might impact outcomes.~   "
9342|NCT02934945|"~     Bronchial asthma is a common respiratory disease characterized by chronic airway~     inflammation, which have been affecting about 1-18% of the population in the world, causing~     tremendous economic burden for the patients and countries. Generally, asthma is a~     heterogeneous disease, and it could be classified into many types on the basis of symptoms,~     that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc.~     Typical asthma (TA) is defined according to the history of repeated respiratory symptoms~     such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible~     airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma~     (CVA) is characterized by the single manifestation, recurrent cough, which could be improved~     after the use of bronchodilators. However, according to different guidelines, it is still~     controversial on the treatment of CVA and TA. The guidelines of Global Initiative for~     Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the~     treatment specific to CVA. The guideline of ACCP（American College of Chest Physicians） and~     cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic~     drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for~     the treatment of CVA. Currently, more and more studies supported that application of ICS~     combined with bronchial dilation agents is more beneficial to CVA patients.~     Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can~     not only be used as a maintenance medication, but also be used as a relief medication,~     namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and~     reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA~     patients. But the study on whether budesonide/formoterol can be used to treat CVA is still~     little. To provide basis for clinical medication guidance for patients with CVA and TA, this~     study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART~     regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function~     and airway reactivity changes, will be measured every mouth. After the study finished, the~     investigators will compare the difference between the two groups.~   "
9343|NCT02934932|"~     Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in~     resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron~     target engagement in a group of subjects with PTSD. All subjects will be evaluated by~     physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing,~     and urinalysis. Results of these studies must demonstrate a lack of clinically significant~     abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and~     receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil~     diameter during pupillometric evaluation after two weeks on each treatment will serve as the~     primary outcome measure. This will be compared in the treatment groups using mixed effects~     repeated measures models to evaluate if there is a significant difference in pupil size~     among the treatments studied. As a secondary analysis this approach will be used to evaluate~     whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will~     compute correlations between pupil size and CAPS-5 scores.~   "
9344|NCT02934919|"~     Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive~     shopping …) are an increasingly recognized psychiatric complications in Parkinson's disease~     (PD). Therapeutic management of these disorders is important since they have an impact on~     patient quality of life. Dopamine agonists play a key role in the emergence of ICD.~      Animal models and imaging underline the implication of opioid system in the genesis of ICD.~      An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al~     2014 have found that patients treated by naltrexone showed an interesting decrease of their~     ICDs measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as~     increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene~     is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an~     agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the~     severity of pathological gambling in patients treated with nalmefene.~      The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment~     of ICDs in PD.~   "
9345|NCT02934906|"~     This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune~     thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an~     appropriate clinical screening procedure~   "
9346|NCT02934893|"~     The benefit of drug therapy to persons with diabetes has been well established in clinical~     trials in terms of reducing cardiovascular risk, microvascular complications and mortality.~     However, treatment adherence and treatment effectiveness continue to be challenges in~     diabetes management.~      Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic~     medications on an individual's glucose profile, allowing the clinician and their patient to~     visualize the anticipated outcome of a medical intervention. Use of this technology should~     allow for more targeted decision-making by the clinician and should facilitate a shared~     decision-making process with the PwD who is now privy to the thought process behind their~     medical management.~      The proposed study is designed to test whether adding a decision support capability~     (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments~     leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.~   "
9347|NCT02934880|"~     Breast cancer is the most frequent cancer in women in western countries. The improvement of~     therapeutic management associated to the developement of supportive care allows patient to~     live longer in better conditions. But several studies have showed the deleterious impact of~     treatment such as chemotherapy on cognition. To limit these damages, non therapeutic~     approaches such as Adapted Physical Activity (APA) have been developped.~      The goal of this study is to evaluate the benefit of APA program on cognitive functions in~     patients with locally advanced breast cancer.~   "
9348|NCT02934867|"~     Medical call center have no phone advice protocol within out of hospital cardiac arrest in~     France. The purpose of the present study is to compare a group of patients with protocol~     phone advice delivered by the dispatchers (CONTARM group) versus usual phone advice (~     CONTHAB group). Comparison will be performed on survival to seven days. The hypothesis is~     that CONTARM group has an higher survival at seven days. A second goal is to measure the~     survival to 15 and 30 days. The trial is randomized, controlled and will include 2600~     patients. The patients will be enrolled in 19 hospitals in France.~   "
9354|NCT02934789|"~     This study aims to evaluate the quality of life in patients treated for submucosal~     leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically.~     Study population includes women age 18 and older with symptomatic submucosal myomas.~     Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of~     Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.~   "
9355|NCT02934776|"~     The purpose of this study is to examine if investigators can improve diagnosis of prostate~     cancer by using MRI/DTI?~   "
9356|NCT02934763|"~     Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy~     volunteers and in animal models. Is defined as an increase in the perception to painful~     stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.~      The apparition of OIH is also related to the exposure to opioids during surgery, depending~     of the dose, the time of exposition and the type of opioid.~      This condition can be modulated, specially in the perioperative context. It has been seen in~     healthy volunteers and in animal models, than the use of propranolol can modulate this~     phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the~     dose of propranolol required to modulate adequately OIH.~      The objective of this work is to evaluate the efficacy of propranolol in the modulation of~     opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.~   "
9357|NCT02934750|"~     This randomized, cross-over study aims at describing the effect of pursed lip breathing on~     exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.~   "
9358|NCT02934737|"~     Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will~     be observed (if any). Anthropometric and biochemical parameters will be evaluated.~   "
9359|NCT02934724|"~     The overall aim of the study is to assess the effect of school-based Human Papillomavirus~     (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and~     non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year~     of vaccine initiation of the 1997-cohort) are invited to participate in the study.~   "
9360|NCT02934711|"~     Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination~     arrangements between professionals on the transformation of modes of exercise of~     professional care, and on the experience of patients / users and that of caregivers,~     particularly on dimensions constituted that the quality of care in order to build a~     coordinated exercise structures rating scale primary care on the basis of criteria suggested~     by patients~   "
9361|NCT02934698|"~     This postmarketing N of 2 study is designed to evaluate the efficacy and safety of~     open-label ivacaftor treatment in two sisters with cystic fibrosis and pancreatic~     sufficiency.~   "
9362|NCT02934685|"~     To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result~     in disease-free survival (DFS) that is no worse than DFS following conventionally~     fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized~     prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom~     from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the~     incidence of GI and GU toxicity.~   "
9363|NCT02934672|"~     The primary objectives of the survey are to obtain patient preference information that can~     be useful during the benefit-risk assessment of the KineSpring System.~   "
9364|NCT02934659|"~     The primary objective of this pilot study is to collect data on the safety and effectiveness~     of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months~     postoperative follow-up.~   "
9365|NCT02934646|"~     This is a phase-II clinical study to assess whether intense passive mobilization of the~     elbow during the early stage is effective in preventing spasticity from occurring at a later~     stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow~     Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was~     assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.~      Investigators expected that intense therapy performed in the sub-acute phase following the~     stroke would be effective in preventing elbow spasticity from occurring at a later stage~     (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified~     Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke~     rehabilitation, the present study will include only one group of patients. As a secondary~     objective, similarly to other studies with robot-assisted therapy, investigators wiil test~     the ability of this system to be used for assessing rehabilitation outcome. Investigators~     will introduce novel evaluation metrics based on the kinematics and kinetics variables~     recorded by the NEEM and compared them with MAS values.~   "
9366|NCT02934633|"~     This project completed an intervention designed to teach parents of children aged 0-2 years~     of age how to prevent injuries to their child. The intervention consisted of a two DVD~     package with information on creating a safe home environment and correctly choosing and~     installing an appropriate car safety seat. The study hypothesis was that parents who used~     the intervention would score significantly higher on measures of knowledge, motivation,~     intention and self-efficacy in implementing injury prevention strategies.~   "
9367|NCT02934620|"~     Globally, women in established relationships remain at risk for unintended pregnancy and~     sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the~     proposed research, unmet need for contraception is substantial as reflected in the nation's~     high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and~     among this group, most were exposed to the virus through sexual activity with their husband.~     Condoms will remain crucial for prevention for some time to come. Sustained condom use,~     however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms~     is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for~     engaging in sex and is an integral part of overall sexual health, most programs to improve~     sexual health operate within a pregnancy and disease-prevention paradigm. A new condom,~     CSD500, containing an erectogenic drug was developed for use among healthy couples to~     improve sexual pleasure by increasing penile firmness, size and erection duration. The~     overall objective of the proposed two-arm randomized trial is to test whether promoting the~     novel condom CSD500 for improved sexual pleasure results in couples having less unprotected~     vaginal sex. Investigators will measure the occurrence of unprotected vaginal sex by testing~     women's vaginal fluid for the presence of prostate-specific antigen (PSA), an objective,~     biological marker of recent semen exposure. Investigators will randomize 500 adult,~     heterosexual, monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 for~     sexual pleasure or the standard condom currently provided only for pregnancy and disease~     prevention to patients during routine care. Study staff will interview female participants~     at enrollment and after 2, 4, and 6 months and their male partners at the 6-month visit.~     Study clinicians will sample vaginal fluid from female participants at all visits to test~     for the presence of PSA.~   "
9374|NCT02934529|"~     The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours,~     optimised with regard to overall survival. The first-line treatment will be conducted with~     FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus~     bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that~     the treatment be continued with FOLFOX plus bevacizumab, as this concept led to~     significantly prolonged survival in the E3200 study. Owing to the encouraging results of the~     Santini study , a cetuximab rechallenge in combination with irinotecan-based chemotherapy is~     to be performed as part of the third-line treatment in patients who showed a response~     defined according to RECIST 1.1 during the first-line treatment (tumour diameter < -30%) or~     presented with stable tumour disease for at least 6 months (tumour diameter +20 to -30%).~     The concept of the ideal sequence has not yet been studied to date in a clinical trial.~   "
9375|NCT02934516|"~     The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction~     with lower uterine segment support in comparison to the classic push method for delivery~     of impacted fetal head during Cesarean section for obstructed labor.~   "
9376|NCT02934503|"~     This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with~     or without radiation therapy in patients with small cell lung cancer (SCLC).~   "
9377|NCT02934490|"~     The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the~     treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS,~     (Johnson & Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA)~     registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The~     incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other~     diagnostic tests were used for preoperative assessment and the evaluation of postoperative~     surgical outcome and complication. The results were compared with the one-year cure rates of~     Burch and trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery~     using the new-style anterior vaginal mesh, as a minimally invasive procedure, not only~     achieved its expectation with similar cure rate to Burch, TVT/ trans vaginal taping~     obturator (TVT-O) surgeries, but also has lower economic cost and complication rate than the~     TVT /TVT-O approach. The evaluation of long-term treatment effect needs further follow-up of~     the patients.~   "
9378|NCT02934477|"~     This observational study will compare outcomes of a prospectively-enrolled cohort of~     Hematopoietic Stem Cell Transplant (HCT) recipients with outcomes of a cohort of age-matched~     historical non-HCT controls. Patients undergoing alloHCT will receive HCT in a US transplant~     center and be reported to the Center for International Blood and Marrow Transplant Research~     (CIBMTR) using well-established CIBMTR report forms and data collection procedures as well~     as a study-specific supplemental form. Data on the historical non-HCT controls will be~     collected at 14 US academic centers. These centers will provide data on all consecutive~     patients with PMF, post-ET MF, or post-PV MF referred to their institutions between 2000 and~     2012.~   "
9379|NCT02934464|"~     This is a randomized, open-label, multicenter phase III trial of ramucirumab plus~     paclitaxel, given as switch maintenance, versus continuation of first-line chemotherapy,~     given as per standard clinical practice, in subjects with unresectable locally advanced or~     metastatic HER-2 negative gastric or GEJ cancer, without disease progression following 3~     months of first-line doublet chemotherapy.~      The acceptable first-line or lead-in chemotherapy will be:~        -  FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2.~          Cycle length is 2 weeks +/- 3 days.~        -  ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400~          mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.~        -  XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is~          3 weeks +/- 3 days.~   "
9380|NCT02934451|"~     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.~     Individuals with osteogenesis imperfecta break bones often and may have other problems,~     including hearing loss and pain and difficulty getting around. People with moderate to~     severe OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by~     grey or brown teeth that may chip and wear down and break easily. People with DI may also~     have skull and neck defects. These patients may have severe teeth misalignment resulting in~     clinically significant chewing problems. Teeth misalignment in OI is very hard to treat~     because of the quality and quantity of bone. The overall goal of this study is to improve~     dental health to improve the quality of life of people with OI.~   "
9381|NCT02934438|"~     Reduced nitric oxide (NO) availability is a hallmark of a number of cardiovascular diseases~     (CVD) including peripheral artery disease (PAD). The investigators will test the hypothesis~     that sub-chronic NEO40™ supplementation will improve vascular NO function and improve~     intermittent claudication in patients with PAD. Using a prospective, double blind, placebo~     controlled experimental design in 30 patients, graded treadmill tests will be performed at~     baseline and after 3 months after randomization, according to the Skinner-Gardner protocol.~     Initial claudication distance (ICD) and absolute claudication distance (ACD) will be~     recorded. Two consecutive treadmill tests will be performed within 1 week at baseline~     (before administration of study drug); and 2 test will be performed at 3 months. Functional~     status will also be assessed by the Walking Impairment Questionnaire and the Health Status~     Survey SF-36 questionnaire (SF-36). Vascular function will be assessed with the use of a~     Vendys® vascular reactivity (endothelial function) test (Endothelix Inc). Digital pulse~     amplitude will be assessed using sensor probes on the index finger during reactive~     hyperemia. Blood will be collected for measurement (by Neogenis) of plasma levels of nitrite~     and nitrate at baseline and at the completion of the study. Based on previously published~     trials using this NO technology, the investigators predict that the group receiving the~     active supplement will exhibit an improvement in claudication distance and all measures of~     vascular function after 3 months.~   "
9382|NCT02934425|"~     The goal of this study is to assess the effects of consumption of a lean pork-containing,~     high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and~     cardiometabolic parameters in overweight or obese adults with pre-diabetes.~   "
9433|NCT02933762|"~     The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose~     response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and~     cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro)~     inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed~     by single and multiple dose administration.~   "
9383|NCT02934412|"~     This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5~     sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5~     dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will~     consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of~     approximately 40 subjects dosed at one study site.~   "
9384|NCT02934399|"~     The study will investigate 27 hour profiles of hormones in the subcutaneous tissue of~     healthy subjects and patients with Addison's, Congenital Adrenal Hyperplasia, Growth Hormone~     Deficiency, acromegaly, Cushings and Primary Hyperaldosteronism during conventional~     diagnostic and therapeutic follow-up.~      The 27 hour monitoring by ULTRADIAN takes into account the rhythm of hormones throughout the~     day. It is hoped that this information may in the future improve and simplify diagnostic~     procedures. Follow-up of patients in endocrinology still remains difficult including~     clinical signs of over and under-treatment, questionnaires of quality of life and blood~     testing necessitating often retesting. Simplification of the diagnostic procedure by~     obtaining detailed knowledge about the rhythm of hormones may contribute to the improvement~     and individualization of treatment and may decrease morbidity and mortality of endocrine~     patients.~   "
9385|NCT02934386|"~     The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to~     the existing CE-marked WinPack device, compared to two reference devices (one oscillometric~     and one volume-clamp device), in healthy subjects and patients undergoing a standardized~     physical-activity hypertensive protocol.~   "
9386|NCT02934373|"~     Clinical study designed to collect user feedback from Cochlear Implant recipients on a new~     Sound Processor System~   "
9387|NCT02934360|"~     The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument~     intended for the measurement of high molecular weight human DNA from plasma as an aid to~     monitoring disease progression or response to therapy or recurrent or residual disease.~   "
9388|NCT02934347|"~     Our hypothesis is that the view of the glottis may be improved by putting all patients~     requiring intubation in the ramped or back up position while maintaining the classic~     sniffing position.~   "
9389|NCT02934334|"~     The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective,~     longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results~     may help refine clinical approach to relapse management, and may ultimately help MDD~     patients sustain wellness while on antidepressant medication.~   "
9390|NCT02934321|"~     Erythritol is a low calorie sugar substitute that is being increasingly used to sweeten~     beverages and other food items. Greater amounts of erythritol are required to reach the~     sweetness level of a common soft drink as compared to aspartame, resulting in higher~     osmolarity for the erythritol sweetened beverage. Since associations have been noted between~     osmolarity and satiety, investigators propose that an erythritol sweetened beverage may~     enhance satiety more than a beverage sweetened with aspartame.~   "
9391|NCT02934308|"~     Pain in hospitalized patients has received increasing attention, however due to its~     subjective nature, it has defied objective, quantitative measurements. If a patient is able~     to communicate, pain may be assessed using standardized sentences, visual analog scales~     (VAS) or plain numeric scales.When a patient is unable to communicate, a method that would~     allow the caregiver to continuously monitor patients' pain and alert the provider that the~     patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement~     technique of analyzing changes in skin conductance that can be used in patients who are~     unable to provide a subjective pain score. This study will compare the relationship between~     the measurements taken by the PainMonitor and pain scores given by communicative patients to~     evaluate the safety and efficacy of this monitor during planned, routine procedures.~   "
9392|NCT02934295|"~     The aim of the research is to study humoral and cellular immunity in pregnant women for who~     the level of rubella virus antibodies is weakly positive, equivocal or negative with the~     usual laboratory technique.~   "
9393|NCT02934282|"~     The purpose of this protocol is to provide treatment with HBOC-201 to patients with~     life-threatening anemia for whom blood is not an option. Such patients may also be referred~     to in this document as patients who refuse blood transfusion (PWRBT). Other patients who~     potentially may require HBOC-201 treatment include those with red blood cell alloantibodies~     for whom immunologically compatible red blood cell units cannot be found, although these~     patients are less common than PWRBT.~   "
9394|NCT02934269|"~     This is a randomized, double-blind, placebo-controlled study to evaluate the safety,~     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following~     administration of single subcutaneous doses in healthy subjects.~   "
9395|NCT02934256|"~     1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2;~     2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of~     Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.~   "
9396|NCT02934243|"~     Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of~     complications there may be situations where it is difficult to insert.~      Therefore it seems appropriate to carry out a prospective observational study that will~     identify the risk factors relating to the positioning of LM for the purpose of~     identification and prediction of them.~      From reading the literature and from the opinion of the experts with extensive practice in~     airway management (part of the Working Group Management of Airway of the Italian Society~     of Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of~     difficulty in the insertion of laryngeal mask have been identified; these possible causes~     were listed in a report that will be distributed to the centers enrolled in the conduction~     of the study.~      1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk~     of each of the factors analyzed in order to identify those that, in view of the LM~     positioning, must be modified to reduce the risk of failure and, secondly, to identify the~     risk factors whose presence may contraindicate the use of the device and indicate the use of~     alternative methods for airway management.~   "
9519|NCT02932644|"~     The aim of the study is to evaluate cardiovascular events during long-term follow-up in~     Rheumatoid Arthritis. The primary outcome any cardiovascular event will be evaluated using~     systematic audits of patient records, and will be associated to low levels of vitamin D at~     baseline, to investigate the hypothesis that low levels of vitamin D can be part of a~     prediction model for cardiovascular disease in Rheumatoid Arthritis.~   "
9397|NCT02934230|"~     The rapid aging of the population means that anesthesiologists care for elderly patients~     with increasing regularity. Although age is an independent predictor or adverse~     postoperative outcomes, significant outcome variation exists among older surgical patients.~     Frailty, a syndrome that describes an aggregate susceptibility to adverse health outcomes~     due to age-, and disease-related deficits that accumulate across multiple domains is a key~     predictor of adverse postoperative outcomes in elderly patients. Frail surgical patients are~     at increased risk of complications, institutionalization, death, and are high healthcare~     resource users.~      Multiple stakeholders, including anesthesiologists and patients, have identified improving~     the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of~     the 10 most important areas for future perioperative research. Physical vulnerability is an~     important aspect of the frailty syndrome, and may be amenable to structured exercise~     therapy. However, the evidence for preoperative exercise training (prehabilitation)~     improving postoperative outcomes is obscured by methodological limitations and a focus on~     non-elderly patients. Recently, evidence has emerged that older and sicker patients may~     benefit most from prehab, however, this hypothesis has not been formally tested.~      Because the complex needs of frail perioperative patients require a longitudinal and~     multidisciplinary approach, the investigators are developing a perioperative surgical home~     for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust~     data collection system, including linkage of prospectively collected data to health~     administrative data infrastructure to improve efficiency and long-term follow up.~      The investigators hypothesize that prehabilitation will be a vital intervention supported by~     the PSH frail, however, high quality evidence from randomized trials is needed to support~     its efficacy. Therefore, the investigators propose a single center randomized controlled~     trial of prehabilitation of frail elderly patients having elective abdominal and thoracic~     cancer surgery to improve postoperative function (primary outcome), and to decrease~     postoperative resource utilization (secondary outcomes).~   "
9398|NCT02934217|"~     Infarct size is a major determinant of vital prognosis after AMI. We recently reported that~     cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly~     reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of~     cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV~     remodelling) at one year after AMI. However, many patients may display increased adverse LV~     remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial~     aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.~   "
9399|NCT02934204|"~     Consolidation treatment for Primary Central Nervous System Diffuse Large B cell~     Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of~     HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.~   "
9400|NCT02934191|"~     Tonsillectomy is one of the most common pediatric surgical procedures in the United States.~     Postoperative pain is substantial, with typical regimens employing narcotic derivatives and~     acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an~     alternative has been tempered by equivocal data on its relative safety in regard to risk of~     postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for~     pain control after tonsillectomy in children. The secondary objective is to assess safety in~     regard to postoperative hemorrhage and adverse events.~   "
9401|NCT02934178|"~     This is a research study about an experimental (investigational) live attenuated Shigella~     sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops~     an immune response. Shigella causes bloody and watery diarrhea, and infants and children~     living in developing countries experience the greatest consequences of this disease. The~     WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination~     will be given to toddlers in the inpatient unit and the second and third doses will be~     administered on an outpatient basis. A safety evaluation will be preformed after the first~     dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose.~   "
9402|NCT02934165|"~     As the leading cause of death and disability in children in America, unintentional injuries~     are a critical public health issue. Most injuries can be prevented by parents implementing~     effective child safety practices. This project produced an interactive multimedia (IMM)~     program delivered via Internet/Intranet that taught injury prevention skills to parents of~     children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability~     from unintentional injury in this population.~   "
9403|NCT02934152|"~     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of~     proton-pump inhibitor has been reported in previous studies. In patients with concurrent~     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of~     H. pylori will aggravate acid-related symptoms after discontinuation of proton-pump~     inhibitor (PPI) remains elusive Objective: This study aims to investigate the incidence and~     severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux~     patients receiving H. pylori eradication Expected result: The investigators will find out~     the incidence and severity of acid-related symptoms after discontinuation of proton-pump~     inhibitor in reflux patients receiving H. pylori eradication~   "
9404|NCT02934139|"~     The present study is designed to assess the safety and tolerability of escalating, multiple~     ascending doses of Cavosonstat (N91115) in healthy subjects.~   "
9405|NCT02934126|"~     Background: The Dutch guideline on breast cancer treatment shows several grey areas, where~     no clear recommendation is given on the radiotherapy options, but where the advice is to~     discuss the treatment of choice with the patient. Currently, patients are exposed to~     different information given by the professionals' personal styles of informing patients. The~     challenge for all oncological professionals is to give clear, structured, and neutral~     information on the pros and cons of the treatment option(s) in the context of the natural~     course of the disease to the patient; to elicit patients' needs and preferences. How and~     which information should be shared in a decision aid is up for investigation, as well as how~     this should best be implemented.~      Research goals: Qualitative assessment of patients' and health care professionals'~     informational needs and perspectives on breast cancer radiotherapy and shard decision~     making.~      Methods: Semi-structured interviews will be held with both breast cancer patients and health~     care professionals. To reach as heterogeneous groups as possible patients of different ages,~     with different education levels and who underwent different treatments or chose not to get~     radiotherapy at all will be selected . Data will be collected til saturation is reached.~     Interviews will be transcribed verbatim and analysed using thematic analysis.~      Results: Results of the qualitative study are expected at the beginning of 2017.~      Hypothesis: Investigating the patients' and health care professionals' perspectives on~     shared decision making and informational needs on radiotherapeutic options will help the~     development of a personalized decision aid eligible for broad implementation.~   "
9734|NCT02929849|"~     The purpose of this study is to determine whether an herb with known alpha-glucosidase~     inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and~     glucose indices in overweight/obese individuals.~   "
9406|NCT02934113|"~     The purpose of this study is to test a workplace intervention program targeted at low SES~     workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level~     intervention that includes an interactive obesity treatment program (iOTA) using SMS text~     messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace~     Participatory Program, which incorporates employee participation in decision making to~     produce changes in the workplace environment that are acceptable, effective, and~     sustainable. These nested interventions will be tested a large delayed-start~     group-randomized trial. This study will rigorously test readily scalable interventions that~     can be translated to other work settings to reduce obesity and diabetes risk among low SES~     workers, a group at high risk for these disorders. This pragmatic clinical trial will~     advance the long-term goal of enabling employers and employees to reduce obesity and~     obesity-associated illnesses including diabetes.~   "
9407|NCT02934100|"~     This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with~     calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs~     treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric~     field diathermy associated with kinesiotherapy and sham laser in combination with~     kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an~     eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.~   "
9408|NCT02934087|"~     This study will evaluate a randomized comparison of direct versus snare techniques for~     cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.~      This information will be used to determine if primary snaring is superior to retrograde~     cannulation in decreasing procedural time and radiation exposure.~   "
9409|NCT02934074|"~     Twenty individuals who were referred to receive physiotherapy will be participants of the~     study. Participants with lower limb loss will evaluate with the following assessment tools:~     Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be~     recorded. Gait parameters (step length, variation of step length) will evaluate with Gait~     Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will~     be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein~     Monofilaments~   "
9410|NCT02934061|"~     Open label, randomized, controlled, multicenter study with two parallel groups of patients~   "
9411|NCT02934048|"~     Strongly evidence supports that H. pylori eradication is an effective approach to reduce the~     incidence of those pathologies. However, due to the increasing resistance rates to~     antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue~     therapy for persistent H. pylori infection is becoming a grand challenge the investigators~     have to face.~   "
9412|NCT02934035|"~     Major depressive disorder (MDD) affects around 7% of the population yearly. Although~     effective treatments are available, only around half of all patients participating in~     clinical trials respond to 6 to 12 weeks of antidepressant treatment. Given these high~     failure rates, the ability to predict as early as possible whether a patient is (un)likely~     to respond would be of great value, as it would enable physicians to change treatment~     strategies faster.~      Early improvement has consistently been found to be a strong predictor of later response.~     However, misclassification is still quite common, with perhaps a third of those who do not~     show early improvement going on to respond. Conversely, a substantial proportion of those~     who do show early improvement do not go on to respond. One possibility for improving the~     predictive power of early improvement is to examine individual symptoms, rather than the~     total score on a depression rating scale. Some items, for example, could reflect~     antidepressant side effects (e.g. gastrointestinal symptoms) and may not be very predictive.~      The proposed project aims to examine the relationship between early improvement in~     individual symptoms and response to antidepressants in a very large patient sample. This~     large sample size makes it possible to use more rigorous methods than previous studies, such~     as the use of cross-validation to confirm the findings. It also makes it possible to examine~     a large set of predictors, including possible interactions among early-improving symptoms~     and between symptoms and demographic factors like age and gender. The added value of~     individual symptoms over and above using the total symptom score alone will also be~     examined, as well as possible differences between different antidepressant classes.~      The project will use penalized (lasso) regression, which is well-suited to analyzing data~     with a large number of (potentially highly correlated) predictors. In the primary analysis,~     response after 6 weeks of treatment will be predicted. In secondary analyses, remission at~     week 6 and response and remission at week 12 will also be predicted.~   "
9413|NCT02934022|"~     Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a~     sustained response with viral loads becoming undetectable and staying undetectable, but do~     not have an increase in their CD4 counts to levels greater than 500. Adding maraviroc to the~     treatment regimen of these patients may result in an increase in their CD4 counts. As the~     patient would be continuing their prior regimen, they will likely continue with full control~     of viral replication.~   "
9414|NCT02934009|"~     The determination of fluid status in dialysis patients is a major clinical problem. In this~     study the NMR-MOUSE is used to determine if it can be used to non-invasively determine~     hydration status of the skin. This evaluation will be performed in dialysis patients and~     healthy volunteers.~   "
9415|NCT02933996|"~     Cardiac surgery usually leads to postoperative immunosuppression, which is characterized by~     predisposition to develop secondary nosocomial infections and high risk of tumorigenesis and~     development. Current studies showed that acupuncture treatment was effective on~     immunoregulation. Our previous study proved that electroacupuncture (EA) can regulate the~     innate immune system overreaction to endotoxin and reduce excessive inflammatory response~     induced by myocardial ischemia and reperfusion. However, whether transcutaneous electrical~     acupoint stimulation(TEAS) can improve immune function in patients post cardiac surgery is~     not clear. The investigators perform a randomized controlled study to evaluate whether TEAS~     treatment can improve the immunosuppression post cardiac surgery, which may provide rational~     for the development of TEAS to treat cardiac patients perioperatively.~   "
9416|NCT02933983|"~     The aim of this study is to investigate whether the microbiota in the upper respiratory~     tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is~     disturbed compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates~     and tissue will be isolated via commercially available DNA extraction kits, followed by~     Illumina MiSeq sequencing in order to identify the bacterial species present in these~     samples. Special attention will go to microbial species that are overrepresented in the~     healthy populations as potential health promoting microbes (i.e. probiotics). A better~     understanding of the URT microbiome might help us to better understand the pathology of CRS~     and might help to develop new microbiota-based strategies for CRS.~   "
9649|NCT02930954|"~     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of~     combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small~     cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or~     low activating EGFR mutation abundance.~   "
9417|NCT02933970|"~     To compare the effectiveness of a patient-centered, opiate agonist treatment~     (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C~     virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care,~     which we anticipate in most cases will be referral to an offsite location for HCV~     management. The effectiveness will be expressed through the primary patient centered and~     clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks~     post-treatment cessation.~   "
9418|NCT02933957|"~     Traditionally, people have always been focusing on vascular injuries by angiography. Recent~     years, the investigators have further known that the pathological foundation of various~     cardiovascular complications not only lies in the vascular lumen, but also vessel wall.~     Therefore, now it is possible to detect and prevent vascular disease early. There are many~     influencing factors on functional and structural damages of vessels, including genetic and~     environmental factors. The investigators have done many researches on populations of the Han~     nationality, which has the largest population in China. Thus, the investigators further~     wonder whether the function and structure of vessel differ in the She Minority of a remote~     southern region in China. The investigators will enroll 150 subjects of two ethnic groups~     respectively in the local population， namely She Minority and Han nationality. All subjects~     enrolled into the study will complete a questionnaire survey of the general situation and~     conduct vascular related examinations, including evaluation of arterial stiffness, arterial~     elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators~     will analysis vascular differences between the two populations and provide a theoretical~     basis for the specific strategies of prevention and treatment.~   "
9419|NCT02933944|"~     The purpose of this study is to determine safety and anti-tumor immune activation generated~     by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy~     (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II),~     in patients with locally recurrent rectal cancer scheduled to have surgery.~      Part I and Part II will include approximately 10 patients each. Part I and Part II are~     separate and independent sequential components of the study. Patients will only be able to~     participate in either the Part I cohort or Part II cohort.~      Main objective of the study is to investigate safety and immune response after~     TG02-treatment.~   "
9420|NCT02933931|"~     This prospective observational cohort study will follow the roughly 100 adults who received~     the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in~     order to determine their long-term (5-year) immune response to vaccination.~   "
9421|NCT02933918|"~     Chronic rhinosinusitis (CRS) is one of the most common chronic diseases, affecting the~     quality of life of patients who suffer. Despite medical and surgical treatments available,~     there are a significant number of people suffering from CRS refractory to these standard~     treatments.~      A preliminary clinical trial conducted at CHUM Hôtel-Dieu, has allowed us to evaluate the~     therapeutic potential of intranasal irrigation of probiotics in patients with CRS. This~     treatment administered twice daily for 14 days was well tolerated and resulted in improved~     chronic rhinosinusitis symptoms.~      Prior to deployment on a larger scale, the safety of this therapy must be confirmed in a~     healthy population, free of sinus disease. Therefore, this study aims to assess the safety~     of the use of probiotic intranasal irrigation in healthy volunteers.~   "
9422|NCT02933905|"~     Influence of the vitreomacular interface on the progression of diabetic macular edema after~     treatment with intravitreal injection of vascular endothelial growth factor inhibitors~   "
9423|NCT02933892|"~     The investigators will conduct a randomized controlled trial that aims to compare the~     incidence of contrast-induced nephropathy between transradial- and transfemoral-access~     cardiac catheterization.~   "
9424|NCT02933879|"~     A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b~     Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT~     topical product in Patients with Mild to Moderate Onychomycosis~   "
9425|NCT02933866|"~     A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III~     Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with~     Mild to Severe Scalp Psoriasis~   "
9426|NCT02933853|"~     A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting~     Insulin Aspart in Subjects with Type 2 Diabetes Mellitus~   "
9427|NCT02933840|"~     The purpose of this study is to determine the efficacy of a remote patient monitoring~     platform and alert system in reducing adverse events for hospitalized geriatric orthopedic~     trauma patients.~   "
9428|NCT02933827|"~     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with~          Moderate to Severe Chronic Kidney Disease~        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with~          Moderate to Severe Chronic Kidney Disease~   "
9429|NCT02933814|"~     This study is being done to evaluate pain management regimens following ambulatory hand~     surgery. Improved pain control may be associated with decreased complications, decreased~     pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and~     reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There~     will be two groups. One group will receive liposomal bupivacaine. One group will not. The~     results will be compared.~      Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will~     participate in this study at LLU.~   "
9430|NCT02933801|"~     The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on~     radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel~     hormonal agents who have non-progressive disease after chemotherapy with a taxane.~   "
9431|NCT02933788|"~     This study evaluates the more suitable treatment for the prevention of vascular~     complications in diabetes patents who were at high cardiovascular risk group by comparing~     the platelet aggregation inhibitory effect of aspirin and cilostazol.~   "
9432|NCT02933775|"~     This study is designed for determining the safety and relative engraftment levels of the~     redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients~     with CD19-positive B cell leukemia and malignant lymphoma.~   "
10256|NCT02922998|"~     The purpose of the study is to find out whether CD64 expression on neutrophils measured by a~     new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy~     in critically ill adult patients at risk of sepsis.~   "
9434|NCT02933749|"~     The sitting or prone positions are used for posterior fossa surgery. Although the sitting~     position may cause hemodynamic instability, venous air embolism, it also provides optimum~     access to midline lesions, decreases intracranial pressure. The sitting position has not~     been only used in neurosurgery, it has been also used in the shoulder surgery. The sitting~     position related hypotension may reduce the cerebral perfusion pressure, therefore may cause~     cerebral ischemia. The sitting position related cerebral ischemia has been shown in the~     shoulder surgery. The non invasive cerebral oxymetry (INVOS-Covidien) has been used to~     measure cerebral oxygen saturation. Some studies has been done to investigate whether the~     sitting position cause cerebral desaturation or not in the shoulder surgery by non invasive~     cerebral oxymetry. The study results are controversial.~      It has been investigated that the effect of the prone position on the cerebral oxygenation~     in the spine surgery and the investigators found that the prone position may increase~     cerebral oxygenation.~      However, all studies have been done in patients without intracranial pathology. We speculate~     that due to the sitting position reduces the intracranial pressure, it may improve the~     cerebral oxygenation in the patients have intracranial pathology. Therefore we will compare~     the sitting and the prone positions effects on the cerebral oxygenation in patients~     undergoing posterior fossa tumour surgery by non invasive cerebral oxymetry.~      Method: 62 patients have posterior fossa tumour will include the study. Patients will divide~     to 2 groups according to the surgical position, the prone (n=31) or the sitting (n=31).~     Patients heart rate, mean blood pressure (MAP), cerebral oxygen saturation (SctO2),~     peripheral oxygen saturation (SpO2), BIS values will record before the induction of~     anesthesia. Five minutes after the standard anesthesia induction all values will record and~     it will accept as a baseline. After that all these parameters will record in each 3 minutes~     until the beginning of surgery. Mean while, more than 5 % reduction in SctO2 and more than~     20 % reduction in SctO2 and/or MAP will record. As well as, if the SctO2 reduces than 55 and~     60 %, it will record.~   "
9435|NCT02933736|"~     In the proposed trial, patients will be administered ribociclib prior to surgical resection~     of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized).~     All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose~     occurring at one of 3 intervals before brain tumor resection.~   "
9436|NCT02933723|"~     The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell~     responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.~   "
9437|NCT02933710|"~     The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical~     settings in accordance with the Ministry of Food and Drug Safety regulation.~      Primary objective:~        -  To describe the safety profile of the first dose of IMOJEV® administered under routine~          health care visit as primary vaccination or as booster.~   "
9438|NCT02933697|"~     The Study is an open-labeled, randomized controlled trial, phase IIIb. Its objective is to~     assess the safety of the factor Xa inhibitor apixaban versus the vitamin-K antagonist (VKA)~     phenprocoumon in patients with NVAF and ESKD on hemodialysis. The safety will be assessed by~     means of the incidence of major and clinically relevant, non-major bleeding on~     anticoagulation.~   "
9439|NCT02933684|"~     The proposed project aims to increase accessibility of exposure therapy, an evidence based~     treatment for social anxiety disorder, by adapting a therapist-assisted computer-based~     program to be delivered in a self-guided manner on an iPad. A significant problem with~     self-guided treatment delivered via computer is compliance. The vast majority of users do~     not complete treatment, so achieving therapeutic benefit as quickly as possible is~     essential. D-cycloserine is a drug found to augment response to therapist-guided exposure~     therapy for anxiety disorders, but has never been tested with self-guided exposure. This~     study uses a randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to~     placebo in combination with self-guided virtual reality exposure therapy (VRE) delivered via~     iPad to treat social anxiety disorder. The proposed study tests the hypothesis that patients~     who receive DCS in combination with the self-guided VRE will show more improvement than~     those who receive placebo in combination with VRE. Outcome measures include self-reported~     symptoms of social anxiety, behavioral avoidance, and diagnostic remission. Participants~     (N=34) are adults with a primary diagnosis of social anxiety disorder. Participants will~     complete a structured diagnostic interview, standardized self-report measures of social~     anxiety, and a behavioral avoidance task (i.e., giving a speech) and will be assessed at~     pre-treatment, at post-treatment and at 3 month follow-up. Hierarchical linear regression~     and chi-square analyses will be used to test differences between those randomized to DCS~     versus placebo on the following outcomes: post-treatment scores of self-reported social~     phobia symptoms, willingness to and anxiety while giving a speech at post-treatment, and~     diagnostic remission at 3 month follow-up. The proposed project combines technological~     advances with translational research to develop an innovative and accessible treatment for~     those with social anxiety disorder. The pilot data generated from this study will be~     appealing to a variety of funding agencies, including the National Institute of Mental~     Health's call for exploratory clinical trials of novel interventions for mental illnesses,~     the Patient-Centered Outcomes Research Institute's call for effectiveness studies aimed to~     overcome barriers to treatment, and the National Science Foundation's call for~     innovation-technology translation research.~   "
9440|NCT02933671|"~     The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI)~     injection technique (also called a nerve block) that numbs the nerves going to the side~     and front of the upper leg will improve pain control after surgery. The SIFI technique uses~     a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce~     pain. This block may affect movement in the leg and make the legs weak. The amount of leg~     weakness is not known and assessment of this will be included in the study. Many~     institutions use the SIFI block for patients having total hip replacements, with the hope of~     providing good pain relief combined with improved mobility after surgery.~   "
9441|NCT02933658|"~     A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing~     clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of~     Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers~   "
9442|NCT02933645|"~     Recent research has suggested that intranasally administered insulin can reach the brain~     quickly without passing through circulation and evoke increased insulin sensitivity and~     tissue glucose consumption during insulin stimulation (low-dose hyperinsulinemic, euglycemic~     clamp). It is still not known what mechanism causes these changes or what tissues are~     involved in this.~      In this study, the changes in tissue-specific insulin sensitivity and glucose uptake will be~     investigated by using glucose-analogue radiotracer ([18F]-fluorodeoxyglucose) with positron~     emission tomography (PET) imaging during insulin stimulation. Ten healthy males are studied,~     each receiving nasal sprays containing insulin or placebo in a randomized order on two~     separate days. After spray administration, glucose uptake in skeletal muscle, liver,~     subcutaneous and visceral adipose tissue, myocardium, intestines, brown adipose tissue and~     brain assessed by PET imaging and glucose uptake in these tissues is analyzed. Endogenous~     glucose production is calculated facilitating the measurements glucose and radiotracer~     uptake in tissues and tracer loss into urine.~      As skeletal muscle consumes most of the glucose available, it is likely that administration~     of insulin sprays will result in an increased uptake in this tissue. Some increase in~     glucose uptake might also be seen in other tissue types after insulin spray versus placebo~     spray administration.~   "
9443|NCT02933632|"~     Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).~   "
9444|NCT02933619|"~     Following product approval, confirmation of appropriate VF episode detection after MRI~     exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold~     changes post-MRI.~   "
9540|NCT02932371|"~     The objective of the study is to estimate the reliability of the determination of the~     cardiac output measured by the ECOM™ device. This study will be performed with the latest~     version of the software which should give better results than those published previously.~     Two techniques of measure of the cardiac output will be compared: the reference measure by~     trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.~   "
9445|NCT02933606|"~     This is a randomised, double-blind, placebo-controlled study, evaluating the effects of~     BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the~     Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).~      The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety,~     depression, global functioning and patient reported outcomes in patients with PTSD. Safety~     and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks~     of blinded treatment followed by a 12 week follow-up period.~   "
9446|NCT02933593|"~     The investigators plan to monitor the central blood pressure in women with severely elevated~     blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3~     different options for blood pressure control, however no one has studied how these~     medications affect the central pressures, only peripheral blood pressure.~   "
9447|NCT02933580|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics~     (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of~     single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.~   "
9448|NCT02933567|"~     In response to the growing need for training on interventions to address first episode~     psychosis, the Center for Social Innovation (C4) has partnered with experts in Coordinated~     Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning~     Platform for Implementing Coordinated Specialty Care. The product builds on the findings of~     the Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National~     Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early~     in the course of schizophrenia. Through a Fast Track Small Business Innovation Research~     (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC~     OnDemand.~   "
9449|NCT02933554|"~     Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis~     (NASH) has been a growing public health issue. Presently there is no cure for~     NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk~     for cirrhosis and may need liver transplant.~      Recent studies have shown that blocking blood vessels to a particular portion of the stomach~     (bariatric or left gastric artery embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to~     determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads~     to clinically significant weight loss with improvement of NASH.~   "
9450|NCT02933541|"~     Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for~     cesarean delivery or epidural anesthesia for vaginal delivery.~   "
9451|NCT02933528|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Maximal Use Treatment with DSXS .~   "
9452|NCT02933515|"~     The long-term goal of this project is to advance best practices in occupational therapy (OT)~     to manage fall risk factors and reduce fall rates in older adults with stroke. To address~     this long-term goal, this team previously developed and pilot-tested a therapeutic yoga~     intervention to improve balance, balance self-efficacy, and fear of falling and a group OT~     intervention to improve the management of fall risk factors and fear of falling. The success~     of both prior studies supports Merging Yoga and group OT to improve balance, balance~     self-efficacy, and fall risk factor management. The objectives of this feasibility study are~     to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess~     change in balance, balance self-efficacy, and fall risk factor management.~   "
9453|NCT02933502|"~     An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with~     Moderate to SevereScalp Psoriasis~   "
9454|NCT02933489|"~     This randomized phase II trial studies how well abbreviated breast magnetic resonance~     imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with~     dense breast. Abbreviated breast MRI is a low cost procedure in which radio waves and a~     powerful magnet linked to a computer and used to create detailed pictures of the breast in~     less than 10 minutes. These pictures can show the difference between normal and diseased~     tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures~     of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening~     with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to~     screen women with dense breasts.~   "
9455|NCT02933476|"~     The purpose of this study is to examine the possibility of a new, non-invasive, non-drug~     treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation~     delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment,~     participants will also undergo kinematic testing.~   "
9456|NCT02933463|"~     This study is designed to clinically evaluate the retention and development of caries when~     using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit~     and fissure sealant in young first permanent molars.~   "
9457|NCT02933450|"~     The Investigator hypothesize that a single dose of patiromer will lower serum potassium~     levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied~     in at least two multicenter randomized controlled trials, the Investigator further~     hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic~     patients in the Emergency Department setting. The FDA approved dosage of 25.2g is~     appropriate for this study because the research staff will enroll patients with moderate (K~     greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used~     in this population for more effective control.~   "
9458|NCT02933437|"~     Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers~     will be performed to observe the various ECG changes. Participants will the undergo detailed~     imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural~     or genetic variants which might dictate the electrocardiographic patterns at rest and with~     sodium channel provocation.~   "
9459|NCT02933424|"~     The objective of this study is to compare the effects of adding three plant-based proteins~     (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and~     subsequent food intake of healthy adults.~   "
10553|NCT02919111|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients~     with high risk disease prior to prostatectomy.~   "
9460|NCT02933411|"~     This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low~     Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge~     of blood and tissues from the uterus. HMB is having a heavier amount of discharge during~     menstrual period. Low Von Willebrand Factor means that the participant has lower level of a~     blood protein that is important for clotting of blood and so, the participant is at a higher~     risk for bleeding.~      The purpose of this project is to study the genetic differences of adolescent females with~     HMB and low VWF activity and compare the genetic differences with their bleeding~     manifestations, response to medications and outcome.~   "
9461|NCT02933398|"~     A prospective, randomized, controlled trial including patients who are diagnosed with a~     small renal mass (<4 cm) amenable to resection using either RALPN or LPN.~   "
9462|NCT02933385|"~     Currently there are very few efficacy studies that integrate classical interventions~     (screening clinics) and online tools in order to obtain sustainable lifestyle changes in~     workers. The current project aimed to evaluate l'efficiency of a combined approach versus~     more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012~     and 2014 showed that, out of 4231 workers, 69% should aimed at a more active lifestyle and~     74% at a better nutrition profile. In addition, 53% of the sampled population was~     overweight. In this context, the current project aimed to motivate and follow individuals~     towards a healthier lifestyle. To do so, the Défi Santé Plus+ will be implemented and tested~     using various versions (light to more complete) in several compagnies.~   "
9463|NCT02933372|"~     Varying oral doses of Varenicline (VCN), starting with very low doses, will be administered~     to participants with Parkinson's Disease (PD) for several days. Positron emission tomography~     (PET) scans after administration of VCN will be used to determine the lowest oral dose of~     VCN producing an adequate brain level of VCN. With an appropriate oral dose of VCN~     identified, the investigators will administer VCN to PD participants to determine if VCN~     improves walking speed and measures of balance. VCN will receive VCN or a placebo (fake~     drug) for 3 weeks to assess the effects of VCN administration on gait speed and balance.~     Participants will undergo examinations to assess the intensity of their Parkinsonism and~     asked questions to assess their mood and thinking.~   "
9464|NCT02933359|"~     The primary objectives of this study are:~      i) to procure human calvarial bone, ii) to grow cells from these tissues in vitro, iii) and~     to evaluate the osteogenic potential of these cells.~   "
9465|NCT02933346|"~     Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated~     under the Temporary Authorization for Use (ATU, compassionate use) setting and describe~     their long-term clinical characteristics, notably the treatments they received after~     nivolumab discontinuation. The profile of these patients shows greater conformity to that of~     a non-selected population, yet the clinical data collection does not reflect real life~     conditions and stops when treatment ends, which does not enable us to get an overview of~     post-immunotherapy treatments.~   "
9466|NCT02933333|"~     The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on~     prevention and treatment of infection in children with malignant tumor.~   "
9467|NCT02933320|"~     The purpose of this study is to identify the tolerable dose of BI-1206 for patients with~     B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an~     anti-CD20 antibody~   "
9468|NCT02933307|"~     Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For~     this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is~     used. Although the MEWS provides relevant data on patients' health status, the interval~     measurements may not capture early deterioration of vital signs, especially during the~     night. As a result, unsafe situations may occur such as periods of low oxygen saturation and~     cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way~     of measuring vital signs may be stressful for patients and disturbs patients' sleep. New~     technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of~     vital signs using wearable devices transmitting relevant data to nurses and clinicians. With~     this, the investigators think that clinical deterioration may be detected in an early phase~     and reduce nurse work load and patient distress.~      Objective: to investigate the feasibility of wearable devices on the general ward.~      Study design: feasibility study.~      Study population: adult patients hospitalized on the internal medicine ward and adult~     postoperative patients on the surgical ward.~      Intervention: patients in the intervention groups will be randomized in one of the two~     groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the~     HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS~     measurements take place at usual time points.~      Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome~     measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS~     measurement (nurse), intervention by nurse after alarm, admission to ICU, complications,~     side effects of devices, STAI scores, and PCS scores will be documented.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients will wear one device for at least three days. Devices can be~     uncomfortable by being heavy or the patches can start itching. More measurements by nurses~     can take place when indicated, for example after alarms. The participating patients will~     fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both~     questionnaires will take a few minutes to complete. Patients could benefit from early~     detection of clinical deterioration and early corrective interventions or ICU admissions.~   "
9469|NCT02933294|"~     Lung cancer is one of the most common cancers in the world. At present, surgical resection~     is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung~     resection is a routine surgically procedure for early stage lung cancer while uniportal~     thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS~     pulmonary resection has been proven to be effective in preventing postoperative morbidities,~     there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is~     equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of~     this multicenter randomized controlled trial study is to compare the uniportal VATS with~     traditional triportal VATS pulmonary resection in postoperative complications, long-term~     survival, lymph node dissection and local recurrence.~   "
9470|NCT02933281|"~     MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The~     active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or~     BCG revaccination administered intradermally on Study Day 0.~   "
9471|NCT02933268|"~     DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum~     water intake in ADPKD.~   "
9493|NCT02932982|"~     Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign~     of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm~     and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's~     clinical situation, in the absence of objective argument. The sense of reinsurance reflects~     a sense of confidence about the patient's situation, in the absence of objective argument.~     Gut Feelings plays a key role in the diagnostic reasoning in general practice. A~     questionnaire measuring the Gut Feelings was validated in French after a linguistic~     validation procedure.~   "
9472|NCT02933255|"~     Background:~      The immune system is the cells and organs in the body that recognize and fight infection and~     cancer. The PROSTVAC vaccine might teach the immune system to find and kill certain prostate~     cancer cells. Nivolumab and ipilimumab are drugs that allow the immune system to fight~     tumors. They might help PROSTVAC work better.~      Objective:~      To test the safety and effectiveness of the combination of PROSTVAC, nivolumab, and~     ipilimumab. To test this for people with castrate resistant prostate cancer and then for~     other people with prostate cancer.~      Eligibility:~      Men ages 18 and older with prostate cancer~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Electrocardiogram~        -  Bone scan~        -  CT scan or MRI~        -  Tumor sample. This may be from a previous procedure.~      All participants will get a combination of the study drugs over 8 weeks. They will have 1~     visit for the initial injection then 3 booster injection visits. Blood will be tested at~     these visits.~      Over the next 4 weeks, some participants will have:~        -  An exam of the large intestine through the rectum.~        -  CT and bone scans~        -  Standard hormonal treatment~        -  Option to continue treatment every 3 weeks if their disease does not get worse. They~          will be have scans every 12 weeks.~      Other participants will have surgery to remove the prostate in week 9.~      Participants will have a safety visit about a month after their last treatment. This will~     include a physical exam, blood tests, and possibly scans.~      If their cancer progresses, participants will leave the study and may enroll in a long-term~     follow-up study. They will be contacted once a year to ask about their cancer and treatment.~   "
9473|NCT02933242|"~     This is a study measuring toxicity while making observations about the survival benefits of~     treating participants with oligometastatic disease using stereotactic ablative radiotherapy~     (SABR).~   "
9474|NCT02933229|"~     Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global~     population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By~     causing progressive damage to the stomach and may eventually result in gastric atrophy, H.~     pylori infection has been demonstrated to be responsible for more than 95% of gastric~     malignancies~   "
9475|NCT02933216|"~     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal~     uterine bleeding in women. No clinical guidelines have been issued for the management of~     CSD. Currently, several limited surgical management procedures for CSD have been reported,~     such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope +~     laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can~     achieve better clinical effects remains unknown. Therefore, this prospective study is~     designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the~     treatment of CSD.~   "
9476|NCT02933203|"~     The purpose of this study is to examine whether stress predicts telomere length in~     individuals who hold executive-level positions. Telomeres are the caps at the end of each~     strand of DNA that may affect how cells age. Subjects will complete an online~     survey/interview and provide one blood sample or saliva samples. The goal is to understand~     whether stress predicts genetic markers of longevity.~   "
9477|NCT02933190|"~     To investigate the fertility in patients after treatment by transvaginal surgery or uterine~     artery embolization combined with uterine curettage~   "
9478|NCT02933177|"~     In order to offer a non-drug intervention for caregivers in nursing home to respond promptly~     to a behavioral crisis with an appropriate response to each patient, a chariot has been~     developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring~     together eleven mediation activities. These activities lasting about 15 minutes are based on~     emotion (reminiscent, games) and sensory interventions (music, massage, touch) to~     decentralize patient stimulus that disturbs and focus on a subject not disruptive. This~     emergency intervention should provide a reduction in Behavioral and Psychological Symptom of~     Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate~     effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The~     secondary objectives are to measure its immediate impact on the well-being and psychotropic~     treatments, and measure its effect after two months and after four months on all BPSD with a~     focus on agitation, the administration of psychotropic drugs, the hospitalizations and the~     number of falls.~   "
9479|NCT02933164|"~     The purpose of this clinical investigation is to evaluate the effectiveness of modified~     Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose~     Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM~     System usage, while in the clinic and during home use.~   "
9480|NCT02933151|"~     To conduct a pragmatic randomized clinical trial in which the researchers will determine the~     mortality impact of a protocol whereby all hemodialysis patients receive an oral,~     protein-based nutritional supplement during the dialysis procedure as compared to the~     existing nutritional protocol whereby only hemodialysis patients with serum albumin below~     3.5 g/dL and incident hemodialysis patients during the first months of care receive an oral,~     intradialytic protein-based nutritional supplement during the dialysis procedure.~   "
9481|NCT02933138|"~     Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive.~     In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG~     lipolysis characteristics will be monitored for 60 minutes after heparin injection instead~     of the 10 minutes gold standard, in a large group of genotyped MCM patients.~   "
9494|NCT02932969|"~     The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and~     pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is~     no formal hypothesis to be statistically tested.~   "
9518|NCT02932657|"~     Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care~     teams perceive the boundaries of a support mainly focused on drug treatments. The patient~     had no other choice but to learn to live with their disease, the goal is to make every~     effort so that tames the disease while maintaining high self-esteem that gives meaning to~     his life, allowing, among other things, a good grip of treatment.~      Through this research we hope to encourage the integration of art therapy and music therapy~     in the course of care of cystic fibrosis patients, from children to adults before and after~     transplantation, in connection with the patient education and counseling~   "
9482|NCT02933125|"~     Background: Substance abuse among children and adolescents is an important public health~     issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and~     Family Court will cooperate in a counseling program for adolescents with illicit drug~     abusers in 2013, to perform a mandatory 10-week family-based group psychotherapy.~      Aims: This study aims (1) to investigate the effectiveness of the family-based group~     psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify~     whether the counseling program is effective for preventing the adolescents from relapse of~     substance abuse.~      Expected Results: The investigators expect that (1) group psychotherapy may involve~     comprehensive benefits for adolescents with illicit drug abusers, by improving the changes~     in adolescents' substance-craving symptoms and behavioral problems, and reducing stress of~     their parents; (2) this counseling program is effective for preventing the adolescents from~     relapse of substance abuse; (3) the findings in this study will not only demonstrate~     empirical evidence of treatment effectiveness for adolescents with illicit drug abuse, but~     will also provide useful clues for future implementation of policy making.~   "
9483|NCT02933112|"~     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner~     in its intended setting. Participants with obstructive sleep apnea will use the device to~     determine their eligibility for oral appliance therapy and provide feedback on usability of~     the device.~   "
9484|NCT02933099|"~     To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA)~     with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal~     carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.~   "
9485|NCT02933086|"~     The relevance of this study is given by the feasibility to assess the effect of an~     intervention program based on the functionality and trunk neuromuscular activity and~     postural control in pregnant women with low back pain. The main outcomes will be computed by~     electromyography measurement so that to assess the trunk neuromuscular activation pattern as~     well as by force platform parameters for determining of postural control. Clinical symptoms~     such as pain intensity, perception of disability and fear and avoidance will also be~     computed. This is the first study to compare two intervention methods using the main~     biological outcomes related to trunk segment function.~   "
9486|NCT02933073|"~     This is a phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage~     III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which~     is predicted to elicit tumor-protective immune responses. A total of 15 patients will be~     enrolled from the Principal Investigator (PI) clinical practice. These patients will have~     successfully completed standard of care surgical debulking, chemotherapy treatment and be in~     clinical remission prior to receiving the vaccine. The patients receive 6-monthly doses of~     the vaccine and are monitored for up to 5 years post vaccination. This is a personalized~     vaccine, unique to each patient and is the first in human use.~   "
9487|NCT02933060|"~     The purpose of this study is to determine whether patients in the emergency department with~     migraine headache who are administered an intravenous fluid bolus will report greater~     improvement in pain scores than control patients.~   "
9488|NCT02933047|"~     Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to~     hysterectomy. It is a safe procedure with low rates of complications and readmissions.~     Increasing evidence indicates that LH may be suitable for an outpatient setting but this may~     impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient~     care to day case surgery might influence readmission rates and postoperative physical~     activity. No data are available on the current length of sick leave in Danish patients after~     hysterectomy, and the effects of outpatient surgery on this parameter are difficult to~     predict. A randomized controlled trial of LH performed as an outpatient procedure compared~     with today's inpatient standard will provide a firm platform for future planning of routine~     treatment of patients with need of hysterectomy for benign indications.~   "
9489|NCT02933034|"~     The purpose of this study is to evaluate the safety and tolerance of a new intravenous~     diagnostic agent , SeeMore or EVP 1001-1, in patients with Cardiovascular Disease. The~     initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed.~     This second phase adds 10 patients in a safety cohort and 60 additional patients for a total~     of 70 patients.~   "
9490|NCT02933021|"~     This is a study to investigate the functional consequences of paraprotein production in MGUS~     (Monoclonal gammopathy of unknown significance).~   "
9491|NCT02933008|"~     Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold~     greater rate in female than male athletes. Consequently, there is a larger population of~     females that endure significant pain, functional limitations, and radiographic signs of knee~     osteoarthritis (OA) within 12 to 20 years FOLLOWING injury. To reduce the burden of OA, The~     National Public Health Agenda for Osteoarthritis recommends expanding and refining~     evidence-based prevention of ACL injury. Specialized training that targets modifiable risk~     factors shows statistical efficacy in high-risk athletes; however, clinically meaningful~     reduction of risk has not been achieved. A critical barrier that limits successful training~     outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and~     accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently~     deliver objective, effective feedback during training for injury prevention. The~     investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young~     female athletes. The overall objective of this proposal is to implement and test innovative~     augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and~     reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal~     is that, after completion, the investigators will be equipped to more effectively deliver~     biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This~     contribution will be significant for the reduction of the long-term sequel following ACL~     injury in young females.~   "
9492|NCT02932995|"~     The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent~     (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage,~     malapposition, and thrombus formation, assessed by an optical coherence tomography.~   "
10120|NCT02924792|"~     In this study we investigate the impact of two CE marked and FDA approved sternal needles in~     comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood~     and the possible hemolysis of red cells post-transfusion in a population of healthy military~     officers.~   "
9495|NCT02932956|"~     This study enrolls patients who have a type of cancer with GPC3-positive solid tumors. The~     cancer has come back, has not gone away after standard treatment or the patient cannot~     receive standard treatment. This research study uses special immune system cells called GAP~     T cells, a new experimental treatment.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. In preclinical studies, the~     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody~     called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors (GPC3-CAR).~     This study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in~     patients with GPC3-positive solid tumors.~      The GAP T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see~     how long they last in the body, to learn what the side effects are and to see if the GAP T~     cells will help people with GPC3-positive solid tumors.~   "
9496|NCT02932943|"~     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg~     compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major~     depressive disorder (MDD) who have a partial response to ADT.~   "
9497|NCT02932930|"~     The original concept of a quadratus lumborum block (QLB) indicated for analgesia after~     abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior~     transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic~     on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP~     blocks have already been proved effective in urologic, abdominal, and gynecologic procedures~     by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount~     of postoperative analgesic medication. The main advantages of QLB compared to the TAP block~     is a wider sensory block area and a longer duration of analgesia. This is due to the~     extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral~     space(4).~      Previous reports have shown that QLB is effective in providing pain relief after various~     abdominal operations. However, there are no published reports on QLB for postoperative pain~     after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to~     evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in~     patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be~     randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline.~     Post-operative cumulative analgesic medication consumption, pain severity at rest and on~     movement, as well as quality of recovery will be evaluated and compared in both groups.~   "
9498|NCT02932917|"~     Place-based cues can be an important trigger of smoking behavior, therefore the~     investigators wish to learn more about the influence of the built environment on individual~     smoking behavior. This is to facilitate dynamic support during the post-quit phase.~     MapMySmoke is a mobile phone application that enables the capture of spatial data during~     smoking and craving events. These data will be used to create individualized support plans~     via the app.~   "
9499|NCT02932904|"~     The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once~     daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants~     after 5 weeks of double-blind treatment.~   "
9500|NCT02932891|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Treatment with DSXS in Patients with Atopic Dermatitis~   "
9501|NCT02932878|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis~   "
9502|NCT02932865|"~     Men are recruited to collect seminal plasma samples and serum samples from men with~     azoospermia, men receiving medical treatment of infertility and men attending semen~     analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the~     groups to find potential differences. Steroid hormones are analyzed by liquid~     chromatography-tandem mass spectrometry.~   "
9503|NCT02932852|"~     Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem~     cells derived from the patient's adipose tissue. The purpose of the study is to assess the~     safety, tolerability, and preliminary efficacy of transplantation of a single dose of~     autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into~     laminas for subjects with corneal defects. 3 groups will be included in the study: (1)~     transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human~     corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on~     scaffold (the human corneal decellularized lamina)~   "
9504|NCT02932839|"~     This study aims to uncover the neuronal bases of epilepsy by recording the activity of~     single neurons in the brain of patients with epilepsy who are candidates for assessment with~     intracranial electroencephalography (EEG). A micro-electrode array will be inserted into the~     brain in addition to the standard intracranial EEG electrodes for up to 4 weeks.~   "
9505|NCT02932826|"~     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo~     expanded umbilical cord blood regulatory T cells on autoimmune diabetes.~   "
9506|NCT02932813|"~     The aim of this study is to examine the effects of a translational health in nutrition and~     kinesiology (THINK) after school program on physical variables, nutrition and exercise~     knowledge base/behaviors, and exercise enjoyment and confidence.~      Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at~     the University of Miami will set up the after-school THINK program offered three afternoons~     per week for nine months in two experimental and two control schools. The schools will~     consist of minority elementary school students (predominantly Hispanic and Black) in the~     South Florida area. The control schools will receive baseline, mid-year and follow-up~     testing nine months later, but will not go through the THINK program. They will instead go~     through their standard YMCA after school Sports, Play, and Active Recreation for Kids~     (SPARK) program.~   "
9507|NCT02932800|"~     Context: The central venous catheter is used in intensive care units for several~     indications, including the administration of drugs with sclerosis potential, infusion~     solutions and hemodynamic monitoring. It can be accessed by per cutaneous puncture using the~     Seldinger technique, which is an extremely common procedure in intensive care units. The~     displacement or accidental removal of central venous catheter caused by poor fixation have~     received little attention, but imply potentially life threatening caused by the~     complications which can result from the removal of the catheter and the need for~     reinsertion. Among these complications, can mention the interruption of vital therapies~     (inotropic and vasopressor drugs) and hemorrhagic shock. In fixing the catheter, the~     literature is not sufficient to assess whether sutures, staples or tapes are associated with~     a higher risk of infections. Objective: To compare the efficiency in fixing the short stay~     central venous catheter using the Ballerina technique associated with flap fixation to the~     usual fixation technique and to observe differences in colonization of microorganisms on the~     device insertion site. Methods: The investigators propose an individual study, analytical,~     intervention, longitudinal, prospective, controlled clinical trial and randomized to be~     developed in the Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio~     Clinical Hospital in The University of Sapucaí Valley and Intensive Care Unit Adult Clinical~     and Surgical of The Hospital e Maternity Santa Paula. After admission of the patient in the~     Intensive Care Unit and obtaining informed consent and informed, with indication of the~     short stay central venous catheter, the patient will be allocated through a table of random~     numbers for the groups: Habitual Fixation (n = 31) and Fixation with ballerina technique~     and flip (n = 31). The participants will evaluate fixation efficiency and colonization of~     the device's insertion site.~   "
9508|NCT02932787|"~     The purpose of this study was to look at the effects that height-adjustable workstations on~     occupational sitting time and workplace productivity in office workers. Participants~     workplace activity (sitting, standing and walking) and productivity was measured before the~     installation of the height-adjustable workstations. Workplace activity and productivity were~     then measured four weeks after the installation of height-adjustable workstations and four~     weeks after the removal of height-adjustable workstations, where possible. The results were~     compared to a control group who received no intervention whilst the intervention had the~     height-adjustable workstations.~   "
9509|NCT02932774|"~     The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl~     syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11~     years old.~   "
9510|NCT02932761|"~     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal~     uterine bleeding in women. No clinical guidelines have been issued for the management of~     CSD. The investigators have previously demonstrated that vaginal repair of CSD was an~     relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to~     less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at~     6 months post vaginal repair. Postoperative menstruation may contribute to surgical site~     infections, which may subsequently affect the healing of uterine scars. Treatment CSD~     patients with gonadotropin-releasing hormone agonist (GnRHa) may has the potential to~     improve therapeutic effects of vaginal repair. Therefore, the current multiple-center~     randomized controlled trial was designed to evaluate whether the application of GnRHa in~     combination with vaginal repair could achieve better clinical effects than those achieved by~     vaginal CSD repair alone.~   "
9511|NCT02932748|"~     The goal of this study is to evaluate the effect of three weight management interventions~     (group phone conference calls, individual phone calls, and enhanced usual care) on weight~     across 18 months in overweight and obese adults recruited through and treated by rural~     primary care clinics.~   "
9512|NCT02932735|"~     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.~     Precisely surveillance of patients with GIM may result in early detection and improved~     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all~     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%~     in those patients.~   "
9513|NCT02932722|"~     This study involves research using human subjects (cardiac surgical patients) to evaluate~     the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC~     applied to upper or lower extremities has been shown cardioprotective role by lowering~     release of cardiac troponin in patients with cardiac diseases. However, it is not clear~     whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect~     of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the~     effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.~   "
9514|NCT02932709|"~     Attempted suicide is a major public health problem, and the efficacies of current~     postvention protocols vary. The investigators evaluated the effectiveness of telephone~     follow-up of patients referred to an emergency psychiatric unit for attempted suicide on any~     further attempt/s over the following year.~      In a single-center, controlled study with intent to treat, they evaluated the efficacy of a~     protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been~     treated for attempted suicide. For comparison, they evaluated as controls patients with~     similar social and demographic characteristics referred to their emergency psychiatric unit~     in the year prior to the study who did not receive telephone follow-up after their initial~     hospitalization. Data were analyzed using logistic regression.~   "
9515|NCT02932696|"~     The main goal of our project is to study and describe the effect of exercise training on~     systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial~     infarction.~      Our working hypothesis is that the intrinsic myocardial contractility and relaxation~     assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction~     exercise training will be improved compared to baseline values as well as compared to values~     in a no-training group. Should this hypothesis prove true, it would help explain the~     improvements in functional capacity observed during the post-infarction period and after~     exercise training.~   "
9516|NCT02932683|"~     This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to~     perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is~     maintained after a 7 week period. Testing the nul hypothesis that there is no difference in~     technical skill completion when performing neonatal resuscitation on a mannequin with or~     without MedNav, immediately after training or after a period of 7 weeks since the training~     episode.~   "
9517|NCT02932670|"~     The aim of this study is to determine the minimum effective volume of lidocaine in 90% of~     patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.~   "
9942|NCT02927119|"~     The purpose of the investigation is to assess iodine status of pregnant women at week 16 of~     gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The~     investigators aim to assess whether pre-gestational initiation of iodine supplementation is~     more advantageous in comparison to supplementation start at the time of pregnancy detection.~   "
9520|NCT02932631|"~     It is estimated that worldwide, about 15 million people are affected by vascular accident~     (CVA) per year, and in Brazil, the stroke is a major cause of death and disability,~     generating too much economic and social impact by generating motor sequelae , sensory and~     cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the~     hemiparesis, which affects about 80% of cases with consequent impairment of the quality of~     life of individuals. However, physical therapy has shown to facilitate return of the~     function of these individuals, while minimizing the sensorimotor deficits for promoting~     neuronal plasticity through the motor relearning. Among the features of physical therapy are~     the conventional physical therapy techniques, Therapy and Restriction of Movement Induction~     (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare~     the application of conventional physiotherapy protocols and TRIM and / or mental practice on~     the morphometric features, functionality and quality of life of post-stroke hemiparetic~     subjects in the chronic phase. 60 volunteers will be selected, of both sexes, aged between~     45 and 80 years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase~     were divided into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice~     group (GPM) and group TRIM + Mental Practice (GTPM) to perform specific exercises for each~     group for three times a week, totaling 24 sessions. Volunteers will be evaluated in four~     times through the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the~     Upper Limb (THMMS) and to assess the Quality of Life will be used Quality Scale Specific~     Life Vascular Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting~     blood and electromyography for muscular activity. After the research data will be tabulated~     on an Excel spreadsheet to perform intergroup and intragroup comparisons between the four~     evaluation times, which will be used for data analysis the BioEstat® 5.2 program, the choice~     of tests for analysis dependent on the statistical distribution types found and the~     homogeneity of their variances.~   "
9521|NCT02932618|"~     The purpose of this study in pediatric participants (<18 years of age) with severe~     hereditary von Willebrand disease (VWD) is:~        1. To assess the efficacy, safety, and tolerability of recombinant von Willebrand Factor~          (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding~          events~        2. To assess the efficacy and safety of rVWF with ADVATE during elective or emergency~          surgery~        3. To determine the pharmacokinetic (PK) profile of rVWF~   "
9522|NCT02932605|"~     The main objective of this study is to compare microglia activation as measured with PET in~     combination with the tracer [11C]-R-PK11195 between recent-onset schizophrenia patients who~     are randomised to CBD and those randomised to placebo.~   "
9523|NCT02932592|"~     To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients~     (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)~   "
9524|NCT02932579|"~     Opioid analgesics are the most common postoperative pain medications used among dentists in~     the United States.Although these medications are highly effective in the postoperative~     dental pain management, not all patients optimally benefit from this therapy. Many suffer~     adverse consequences such as nausea, emesis, and psychomotor impairment, and there is a high~     prevalence of opioid prescription misuse among substance abusers within the dental patient~     population.~      The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of~     postoperative dental pain has demonstrated equivalent or superior analgesic effects compared~     to opioid analgesic therapies, typically with significantly less adverse effects.However,~     despite these results, dentists have encountered a high variability in the success of~     non-opioid analgesic responses among the postoperative dental pain population.Thus, new~     strategies for earlier recognition of analgesic responses for pain medications is~     fundamental in the field of dentistry. Therefore, this study will evaluate the clinical~     utility of pharmacogenomic testing in acute postoperative dental pain management among~     healthy adults who undergo extraction of impacted mandibular third molar.~   "
9525|NCT02932566|"~     This randomised, double-blind, placebo-controlled, phase 2 study aims to evaluate the~     efficacy and safety of the anti-fibrotic drug pirfenidone in the treatment of patients with~     heart failure and preserved left ventricular ejection fraction (HFpEF). Participants will be~     randomised to receive either pirfenidone or placebo, for a period of 12 months.~   "
9526|NCT02932553|"~     The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold)~     implantation with optimal medical therapy can improve the outcome of patients with variant~     angina and moderate coronary artery disease.~   "
9527|NCT02932540|"~     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally~     maintained at a constant level, over a relatively wide blood pressure range. It can be~     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using~     ultrasound probes over both sides of the head to measure changes in blood flow in one of the~     main brain arteries (the middle cerebral artery) in response to beat to beat changes in~     blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired~     following moderate to severe stroke, acting as a key role in the development of secondary~     brain damage related to brain swelling and further damage related to the low blood flow. The~     administration of clot busting therapy (thrombolysis), one of the main approved treatments~     of acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only~     approximately 50% of patients. Therefore, as well as attempts to treat major vessel~     blockage, improving brain blood flow, particularly to the penumbral area, through arteries~     that bypass the blockage is another potential therapeutic approach in AIS.One simple way of~     achieving this might be to lower the head of AIS patient into a lying flat (0⁰) position.~     However, to date, there have been very few studies exploring this. This research will use~     the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in~     different head positions, both in healthy volunteers and AIS patient. This study will~     provide important data regarding blood pressure management in acute stroke, an important and~     common clinical dilemma.~   "
9553|NCT02932202|"~     Obesity and excessive weight gain in pregnancy have significant associated maternal and~     fetal complications including gestational diabetes, large for gestational age infants, birth~     trauma, and stillbirth. The standard of care places the responsibility on the providers~     during prenatal visits to remind patients of their weight gain goals and provide appropriate~     counseling. The objective of this study is to evaluate a sustainable medical~     student-assisted longitudinal program of nutritional counseling and web based nutrition~     tracking for pregnant women on excessive weight gain during pregnancy and the effects on~     diet choices and fetal and maternal complications.~   "
9650|NCT02930941|"~     It is estimated that epistaxis results in 4.5 million emergency department visits per year~     throughout the United States. Due to the adverse effects of standard treatment options for~     epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous~     studies, when used with nasal packing, TXA showed faster time to control of bleeding. The~     goal of this study is to determine the efficacy and safety of topical intranasal TXA applied~     via atomizer for patients with epistaxis who present to the emergency department.~   "
9528|NCT02932527|"~     Lifestyle and environmental factors can disrupt development and testicular function. In~     France, cannabis is the most widely used illicit substance and about 8% of adults between 18~     and 64 years smoke cannabis at least once a year, and mostly men under 45 years.~     Endocannabinoids are lipid mediators that share some effects with the active ingredients of~     cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were~     detected at different levels of the reproductive system and are involved in the central and~     local regulation of the gonad. Cannabis use may alter the normal regulation of the~     endocannabinoid system. In males, the regulation of the endocannabinoid system is critical~     for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm~     nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters,~     capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and~     induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility~     are scarce or nonexistent in infertile men because of ethical considerations and bias due to~     consumption often underreported. Investigators hypothesized that cannabis use may alter~     sperm nuclear quality. Investigators want to explore this hypothesis conducting a~     multicentric prospective study exposed/non-exposed in infertile men who are consulting for~     Medically Assisted Reproductive Technologies (ART). To reach this study, it is planned to~     include a total of 200 subjects taking into account any exclusions.~   "
9529|NCT02932514|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Eversense~     Continuous Glucose Monitoring System (Eversense System) measurements when compared with a~     Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance~     in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System~     usage, and assess the usability of the Eversense system in the hands of user at home~     setting. Changes in HbA1c from baseline will also be evaluated.~   "
9530|NCT02932501|"~     Approximately 500 patients will be included in this patient registry. Data collection~     includes demographics, clinical data of underlying disease and use of bisphosphonates,~     denosumab and antiangiogenic drugs , degree and extension of osteonecrosis,~     osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.~   "
9531|NCT02932488|"~     The purpose of this study is to show that PET-MR imaging can be used for obtaining a~     pharmacodynamic profile of drugs. By using the 5-HT1B receptor as target we also aim to find~     effect areas and sizes of the 5-HT1B receptor agonist sumatriptan.~   "
9532|NCT02932475|"~     Purpose: The objective of this proposal is to study the safety and efficacy of metformin~     added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.~      Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.~     clinical centers~      Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a~     singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary~     outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth~     trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical~     visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.~   "
9533|NCT02932462|"~     A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III~     Clinical Study~   "
9534|NCT02932449|"~     This is a 5-year, longitudinal, observational study of patients with PBC designed to~     specifically address important clinical questions that remain incompletely answered from~     registration trials. In addition to the study database, a bio specimen repository will also~     be included so that translational studies of genomics and biomarkers of response may be~     performed.~   "
9535|NCT02932436|"~     The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in~     addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function~     in patients with type 2 Diabetes mellitus.~   "
9536|NCT02932423|"~     The purpose of this clinical study is to investigate the effect of drinking a~     sugar-sweetened beverage along with a meal on insulin concentrations and, glucose and lipid~     metabolism, in overweight and obese subjects, during a 10-hour visit.~   "
9537|NCT02932410|"~     This is a prospective, multicenter, open-label, randomized, controlled, parallel group,~     group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and PK of~     macitentan in children.~   "
9538|NCT02932397|"~     Emergence of general anesthesia is a critical period, in the same way as the induction of~     anesthesia, during which several adverse events may occur. Extubation may even be more~     difficult than the intubation, with a higher respiratory complications rate. Among these,~     cough is common and expected. It can be associated with significant complications including~     hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or~     even wound dehiscence.~      The incidence of coughing during emergence of general anesthesia varies depending on the~     type of airway instrumentation, the population under study, agents used for the maintenance~     of the anesthesia and techniques used to prevent coughing. In the literature, the incidence~     of coughing during emergence of general anesthesia under endotracheal intubation varies from~     38 to 96%. In our center, the incidence of coughing during emergence of general anesthesia~     under desflurane and endotracheal intubation is 30 % according to a local preliminary study.~      Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is~     associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy~     of propofol at a subhypnotic dose to reduce coughing during emergence has recently been~     demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most~     effective antitussive dose remains unknown and its efficacy during anesthesia under~     desflurane has not yet been demonstrated.~      Propofol is rapidly available, simple to administer and has an interesting pharmacological~     profile, among others due to its short half-life.~      The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is~     more effective than placebo administration to decrease the incidence of coughing during~     emergence of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the~     incidence of postoperative nausea and vomiting (PONV).~   "
9539|NCT02932384|"~     The proposed research study will focus on Black men who have sex with men (BMSM) who~        -  are HIV- or unknown status AND~        -  have not received HIV testing in over a year or~        -  who test irregularly (on 9/21/2016, the protocol was changed to modify the last to~          criteria and focus on those who have not used PrEP in the prior six months).~      and implement an innovative, culturally-informed, peer-based, and client-centered approach~     that is designed to increase their awareness of their HIV status and their timely entry into~     prevention (including PrEP), testing, care, and treatment services. The research design~     compares the effect of an incentives-only approach to one that uses incentives, along with~     the involvement of peer mentors to support timely entry into prevention, testing, care and~     treatment. This phase of the study is designed to assess peer-supported intervention group~     versus a passport/incentive-only control group over an 18-month period using a randomized~     trial approach.~   "
9541|NCT02932358|"~     The aim of the present cluster-randomized cross-over trial is to evaluate the effectiveness~     and safety of an extended policy of visitation in intensive care units. Near 35 to 40 ICUs,~     in Brazil, will be randomly assigned to either an restricted visitation model (intermittent~     visits according to local ICU regulation) or to an extended visitation model (12 consecutive~     hours per day). After enrollment of 25 patients, there will be a 30-day period without~     patient enrollment (to avoid contamination bias). After this period, each ICU will be~     assigned to an intervention contrary to that which initially receive until the enrollment of~     more 25 patients. The primary outcome will be incidence of delirium among ICU patients.~     Secondary outcomes include length of ICU visitation per patient per day, delirium-free days,~     antipsychotic use, need of mechanical restraints, unplanned loss of invasive devices, length~     of mechanical ventilation, any ICU-acquired infection, ICU-acquired pneumonia, ICU-acquired~     bloodstream infection, ICU-acquired urinary tract infection, any ICU-acquired multi-drug~     resistant infection, ICU length of stay, and hospital mortality among ICU patients; anxiety,~     depression, and satisfaction among family members of ICU patients; burnout syndrome symptoms~     among ICU-workers; any adverse event related to ICU visitation.~   "
9542|NCT02932345|"~     The primary objective is to describe the genomic profile of long-term survivors, especially~     to find out potential genomic prognosis and/or predictive factors for gefitinib long-term~     efficacy as compared to rapid PD patients~   "
9543|NCT02932332|"~     The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,~     high-flow air, and low-flow air in helping to decrease shortness of breath in cancer~     patients. Researchers also want to learn if these therapies can help to improve lung~     function and quality of life.~   "
9544|NCT02932319|"~     15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley~     catheter induction at home versus expectative in this population~   "
9545|NCT02932306|"~     Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris~   "
9546|NCT02932293|"~     There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60~     mg) in this study but the treatment duration may be different depending on patients'~     response to the antiviral therapy and whether patients have liver cirrhosis. If patients~     have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive~     sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4~     weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients~     will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment~     duration will be 8 weeks.~   "
9547|NCT02932280|"~     The purpose of this study is to test the safety of neratinib at different dose levels and to~     find out what effects, good and bad, it has on the patients and the cancer.~   "
9548|NCT02932267|"~     This is a multicenter open-label, prospective study in subjects with dark skin from one of~     the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with~     moderate to severe acne vulgaris on the face.~      All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump~     Forte) once daily on whole face.~      The purpose of this trial is to evaluate subject reported outcomes with the combination of~     Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment~     of moderate to severe acne in dark skin phototypes (IV to VI).~   "
9549|NCT02932254|"~     The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 /~     T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by~     rocuronium.~   "
9550|NCT02932241|"~     Alcohol use is considered to be a significant risk factor among those who die by suicide,~     especially among those who drink to regulate their emotions. Unfortunately, there is a~     dearth of treatment outcome research for suicidal heavy drinkers. Further, treatments that~     target this population must be maximally effective, with promise for wide dissemination. The~     application of technology has been increasingly utilized as an efficacious and acceptable~     way to rapidly disseminate evidence-base treatment. However, these methods are used~     infrequently for individuals deemed too high risk for computerized treatment. Along these~     lines, the goal of this project is to begin a line of research focused on developing~     interventions to reduce heavy drinking and risk for suicide through the use of technology.~     Dialectical Behavior Therapy (DBT) skills training is an effective intervention for~     behaviors associated with emotion dysregulation including addictive and suicidal behaviors.~     Further, DBT skills use has been identified as the active ingredient for treatment~     effectiveness; thus, a skills training intervention delivered via the Internet has the~     capacity to be a potent and efficient method of treatment delivery. The goal of this~     research is to establish a proof of concept for developing and evaluating a potentially~     efficacious and acceptable intervention for heavy episodic drinkers who are suicidal.~     Specifically, this project proposes to conduct a randomized controlled pilot trial of a~     computerized DBT skills training intervention for suicidal individuals who engage in heavy~     episodic drinking (HED) to regulate emotions. The project's aims are to conduct a randomized~     controlled pilot trial of cDBT vs. a Wait-list control (WL). This pilot trial is not~     intended to demonstrate that cDBT works better than other interventions in improving~     clinical indices, but rather to determine whether further revisions of the cDBT intervention~     are needed and will inform the design of a subsequent full-scale randomized controlled~     trial.~   "
9551|NCT02932228|"~     This evaluation will examine the feasibility, implementation, and effectiveness of a quality~     improvement intervention—Intensive Management Patient Aligned Care Team (ImPACT)—for~     high-risk patients.~   "
9552|NCT02932215|"~     This is a 10 week, open-label, prospective study, involving 10 volunteer participants with~     cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to~     the feasibility, likability, and utility of a mobile sensor device in cannabis users. The~     study will be entirely outpatient. Upon study entry, participants will begin clinic visits~     at the Substance Treatment and Research Service (STARS) clinic. All consented participants~     will receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive~     lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week~     10 following discontinuation of lorcaserin, the participants will continue to wear the~     Fitbit Charge HR device for this final week following completion of the medication trial.~     All participants will visit the clinic twice weekly to provide urine toxicology on THC,~     report on adverse events, complete additional assessments (outlined below), and upload~     de-identified data from the Fitbit Charge HR device to the secure encrypted Fitabase~     database. Study assessments will be collected at baseline, throughout the study, and 1 week~     following medication discontinuation. All participants will also receive medical management,~     a medication adherence focused psychosocial intervention that facilitates compliance with~     study medication and other study procedures, including adherence to wearing the Fitbit~     Charge HR device, and promotes abstinence from cannabis and other substances. Progressive~     voucher incentives will be provided for compliance with visit attendance and study~     procedures.~   "
9554|NCT02932189|"~     Introduction:~      It is well established that physical fitness improves muscle performance either in sedentary~     people or in athletes. In this regard, specific exercises for respiratory muscles can result~     in better functional performance in hospitalized individuals, especially in critically ill~     patients in prolonged weaning.~      Objectives:~      To compare the following variables between intervention and control patients: success in~     weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the~     use of the inspiratory muscle training (IMT).~      Patients and methods:~      Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will~     be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary~     endpoint will be successful weaning. In addition, other variables such as free time off~     ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality~     in the ICU, inside the hospital and after discharge will be followed for one year after~     study entrance.~      Expected results:~      According to the working hypothesis, it is expected that the performance of patients~     undergoing IMT will be superior to the conventional treatment. Also, their time to mortality~     is expected to be longer.~   "
9555|NCT02932176|"~     The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous~     in clinical practice. However, most users have received no formal training in their use or~     the interpretation of the returned data. This leads to delays in diagnosis and errors in~     diagnosis.~      The investigators intend to create a novel machine-learning algorithm to assist clinicians~     in the use of this data. This study will allow the investigators to collect sound files from~     the use of the devices and compare the algorithms output to established, existing vascular~     testing. There will be no invasive procedures, and use of these stethoscopes is part of~     routine clinical care.~      If successful, this data and algorithm will be later deployed via smartphone app for point~     of case testing in a separate study~   "
9556|NCT02932163|"~     Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the~     lower back for at least three months with no known causes. The CNSLBP prevalence is~     estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs~     on the patients and the society. Whereas a specific pathology has not been identified for~     CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may~     contribute to the pain and disability.~   "
9557|NCT02932150|"~     The primary objectives of this study are as follows:~      Part A: To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (TAF)~     and confirm the dose of TAF 25 mg tablet given once daily in treatment-naive and~     treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB)~      Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of~     TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and~     treatment-experienced adolescents with CHB.~   "
9558|NCT02932137|"~     The objective of this clinical study is to evaluate the potential effect of anti-infection~     of low-does IL-2 in patients with SLE.~   "
9559|NCT02932124|"~     The aim of this study was to analyse a large CPR database, the German Resuscitation~     Registry, to evaluate potential benefits of mechanical CPR devices over manual CPR in adult~     cardiac arrest victims. The primary endpoint considered is ROSC.~   "
9560|NCT02932111|"~     The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel~     dysfunction during recurrent periods of shorter or longer duration. The absence of~     well-defined pathophysiological marker requires a clinical definition. The most used are the~     Rome criteria III whose version was published in 2006 and version IV under development.~      An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people,~     found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of~     4.8%.in the total population; the results of this study were comparable to data obtained in~     the USA. A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all~     these studies, there is a very large predominance of women (sex ratio near 2), with a~     preponderance of subjects of the age group 40-50 years.~      IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs~     generated by associated diseases: number of visits to the general practitioner, to the~     specialist, the prescription and realization of complementary examinations, hospitalization,~     purchase drugs and work stoppage.~      From a pathophysiologic perspective, IBS is now considered as a multifactorial disease~     involving varying degrees, depending on the individual variables, visceral hypersensitivity,~     disturbances of digestive motility, impaired sensorimotor way communications between the~     gastrointestinal tract and the central nervous system, intestinal micro-inflammation.~      Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve~     the symptomatology of IBS in patients with functional gastrointestinal disorders.~   "
9561|NCT02932098|"~     Purpose: The purpose of this study will be to test the use of a web-based mobile application~     (app) initiated at the time of hospital discharge to engage and monitor patients in order to~     efficiently deliver better outcomes. The mobile app will be used to remind patients of~     discharge instructions, assess adherence treatment regimens, and evaluate symptoms.~      Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at~     diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent~     evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery~     will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a~     50% increase in one-year mortality rates and significantly increased costs of care. In~     addition, many of the conditions and complications that led to readmission could potentially~     have been avoided with more intensive post-surgical follow-up care. Mobile health~     technologies can effectively and efficiently connect patients with their healthcare team and~     have been shown to improve treatment adherence and reduce avoidable ER visits and~     hospitalizations.~   "
9562|NCT02932085|"~     This study is a randomized, double-blind, and sham-controlled trial to examine the effects~     of transcranial magnetic stimulation on the brain of health individuals.~   "
9563|NCT02932072|"~     Microscopy remains a key indicator in drug efficacy testing performed in the context of~     clinical trials for monitoring existing antimalarials or in the context of regulatory~     clinical trials for registration of new drugs. It is one of the main diagnostic methods for~     malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate~     diagnosis, determine the density of parasites in the blood, and accurately differentiate~     between different malaria parasite species, characteristics vital to the implementation of~     global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for case~     management, do not provide information on the parasite density nor the species~     differentiation necessary for research and drug efficacy assessment. Microscopy therefore~     retains key advantages over a number of newer technologies, but its reliability is severely~     impeded by dependence on high technical competence of the human operators as well as~     availability of high quality equipment and reagents. Recent studies have demonstrated the~     frequent poor specificity and sensitivity associated with manual microscopy diagnostics in~     operational conditions , , . Advances in digital microscopy performance and affordability~     have now opened the door to potentially significant improvements in the performance of~     malaria diagnostic microscopy, overcoming serious deficiencies in current drug efficacy~     assessment, and more broadly in malaria diagnosis and management.~      Intellectual Ventures Laboratory (IVL), in collaboration with Global Good Fund (GG), has~     developed an initial microscope prototype to support its research into dark field imaging of~     unstained malaria slides. The system consists of low cost electromechanical components for~     scanning a standard slide, an optical train with a high numerical aperture objective, and an~     image capture system. Captured images are analyzed with custom image analysis software~     developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis,~     without user input. Additionally, image processing algorithms have been built around~     detection of Giemsa-stained malaria slides which is the current standard for malaria~     microscopy. Initial results show excellent potential for sensitivity and specificity which~     exceeds that of typical manual microscopists in the field. Based on the positive market and~     needs assessment in January, 2013, given by stakeholders in the malaria diagnostics~     community, GG/IVL are pursuing improvement and integration of this algorithm into a portable~     microscope platform with characteristics similar to the prototype microscope already~     developed at GG/IVL for dark field imaging. The prototype Autoscope was first tested in~     field settings in Thailand in Nov 2014 - Jan 2015 at clinics operated by the Shoklo Malaria~     Research Unit (SMRU). The goal of the first field evaluation was to assess the Autoscope in~     with respect to its diagnostic performance and also its suitability for harsh conditions~     typically encountered in field clinics. Further, user feedback on the design and~     functionality was sought. The Autoscope and the accompanying image analysis algorithms have~     since been further developed and a new version is now available for testing.~   "
9564|NCT02932059|"~     The purpose of this study is to determine the respective roles of aging and schizophrenia in~     the regulation of metamemory using a sentence construction strategy. 4 groups will be~     necessary to comparison:~      Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged~     controls (≥ 55 years)~      The effects of age and the disease could lead to interaction in regulating metamemory. The~     effect of age would be aggravated by the disease.~   "
9565|NCT02932046|"~     Anorexia means loss of appetite. But there is disagreement about whether the appetite is~     changed by the disease anorexia nervosa (AN). Appetite is a subjective essential sense,~     which is regulated in a complex ensemble between brain, stomach - intestinal system and~     hormones. As a direct result of malnutrition, there are many somatic complications caused by~     the disease AN. Several of these complications may in itself affect hunger- and satiety~     perception. An example of this is delayed gastric emptying. Furthermore, changes in the~     hormone systems affects the biological reward system in the brain, which plays an~     important role in appetite regulation. There is clearly need for research that could lead to~     better treatments for AN. Hunger- and satiety perception has only been studied in a few~     small cross-sectional studies with no clear conclusion.~      The purpose of the study is to determine whether a visual analog scale measurement can~     detect changes in hunger- and satiety perception in a least 30 patients admitted to~     nutrition for life-threatening severe anorexia nervosa. It may lead to the first step in the~     development of a simple and inexpensive instrument which may prove to be useful in measuring~     the impact of new and ongoing treatments of the disease.~   "
9566|NCT02932033|"~     This prospective randomized trial is performed to analyze the post-operative pain (acute and~     chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.~   "
9567|NCT02932020|"~     In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft~     derived from amniotic fluid, injected into the epidural space at the level of spinal~     stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients~     with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The~     effect of this treatment will be examined by patient reported changes in pain and disability~     utilizing validated outcome measures, and MRI imaging evaluating changes in contrast~     enhancement and T2 signal related to that reflect inflammation and degeneration.~   "
9568|NCT02932007|"~     The goal of this pilot study is to explore the efficacy of chloroquine in terminating~     persistent and longstanding persistent AF and assess its potential role as a pharmacological~     cardioversion agent for the management of AF.~   "
9569|NCT02931994|"~     Removal and prevention of formation of dental plaque biofilms is one of the current hygiene~     regimen to prevent, reduce or even reverse the gingival and periodontal disease condition.~     In such endeavors of mechanical plaque removal, tooth-brushing and use of dental floss play~     an important role. Gomes et al have presented a modification in the use of knotted floss in~     wider embrasure areas. The modification in the dental floss has been done so as to increase~     the effective width of the floss. The purpose of this study is to compare the reduction of~     the clinical signs of plaque accumulation, gingival inflammation and gingival trauma in the~     area the knotted floss technique has been utilized versus the area where conventional~     flossing has been utilized in Type I gingival embrasures. Patients' acceptability of the~     knotted flossing technique will also be evaluated. This study is part of a larger study~     protocol involving different sample groups comparing the knotted floss technique with~     conventional dental flossing, use of interdental brushes and unitufted brushes in type II~     and type III embrasures as well.~   "
9570|NCT02931981|"~     Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of~     gastrointestinal stromal tumor.~   "
9571|NCT02931968|"~     This study is designed to recall all patients who have received a full-arch monolithic~     zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC)~     School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between~     January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and~     technical complications associated with this form of prosthetic treatment. Additionally~     patient centered outcomes will be evaluated.~   "
9572|NCT02931955|"~     Study Objective Allergies affect up to 20% of the population of developed countries and can~     cause substantial individual disease burden. For some allergies, immunotherapeutic regimens~     (hyposensitization) have been established, e.g. for insect venom allergies and pollen~     allergies. This project aims at identifying the T cell activation potential in vivo from~     resting T cells of patients undergoing immunotherapy (IT) via a systems biology approach.~     For the participants, it involves blood draws and stool collection as well as gathering some~     basic medical information. The participation takes one week for patients undergoing insect~     venom IT and three months for patients undergoing pollen IT.~      This study is a cooperation project between the Centre Hospitalier de Luxembourg (CHL), the~     Luxemburg Institute of Health (LIH), the University of Luxembourg and the Integrated Biobank~     of Luxemburg (IBBL).~   "
9573|NCT02931942|"~     Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and~     maturation of T lymphocytes and NK cells. Chemotherapy results in depletion of those cells~     and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma~     of several patients after chemotherapy for hematological malignancies. AA suppletion could~     be beneficial to the recovery of the immune system in these patients. But before an~     intervention study can be undertaken, further understanding of changing over time of AA~     levels and the relationship with the immune status after chemotherapy is necessary.~      Objective: The aim of this pilot study is to evaluate the changing over time of AA levels in~     plasma and in leukocytes before and during chemotherapy treatment for several different~     groups of patients and compare that to healthy controls. In this way we want to identify the~     patients were further interventions could be useful and use the data in the development of~     an intervention study for power calculations and to identify the primary endpoint.~      Study design: observational study~      Study population: There will be 6 different groups of participants in the study: two groups~     of patients that receive clinical intensive chemotherapy (acute leukemia and high dose~     chemotherapy with autologous stem cell rescue), two groups of patients that receive~     relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two~     control groups. All participants will be adults and recruited at the MUMC+. In total there~     will be 150 participants.~      Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in~     leukocytes.~   "
9634|NCT02931149|"~     To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic~     Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to~     avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has~     demonstrated efficacy in preclinical endoscopic resection models.~   "
9574|NCT02931929|"~     Tyrosine-kinase Inhibitors (TKI) resistance in gastrointestinal stromal tumours (GIST) is a~     common problem after prolonged treatment periods. The main objectives of this monocentric~     diagnostic Phase I/IIa study are safety and tolerability, pharmacokinetics and dosimetry of~     68Ga-NeoBomb1 in GIST patients. The rationale behind this study is to improve diagnostic~     accuracy in GIST via positron-emission tomography/computer tomography (PET-CT) with a focus~     on TKI-resistant subtypes. Better detection, classification and definition of lesion extent~     are expected from the use of 68Ga-NeoBOMB1.~   "
9575|NCT02931916|"~     The purpose of this study is to evaluate the reliability and validity of smart-phone based~     system in postural control ability assessment on subjects with chronic ankle instability.~   "
9576|NCT02931903|"~     The aim of this study is to assess the effect of the newly introduced (hybrid dental~     ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient~     satisfaction and crestal bone loss.~   "
9577|NCT02931890|"~     The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric~     cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and~     subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design~     is based on the following concepts:~        -  Preoperative treatment is associated with better patient compliance than postoperative~          regimens~        -  Preoperative treatment increases the likelihood of disease downsizing/downstaging and~          radical R0 resections~        -  Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC~          chemotherapy are effective, feasible and safe regimens~   "
9578|NCT02931877|"~     As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly~     well-documented clinical phenomenon, which affect patients' short-term and long-term~     outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB)~     during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia~     are most commonly used strategy for general anesthesia. At present, it was unknown that~     which one is better in providing cerebral protection effect for patients undergoing cardiac~     valvular surgery with CPB. The current study aimed to explore the possible difference.~   "
9579|NCT02931864|"~     Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors~     usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or~     radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and~     anxiety/depression. Currently, there is no study to include both symptom management and~     mindfulness training components for breast cancer survivors. And given breast cancer~     survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom~     management and mindfulness training programme for breast cancer survivors and to determine~     its effects on quality of life, symptom distress, psychosocial adjustment, psychological~     morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer~     survivors. We employ a randomised clinical trial with four study arms (with 47 subjects in~     each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental~     group: five weekly sessions of online symptom management + mindfulness training programme~     and usual care), group 3 (comparison group 1: five weekly sessions of online symptom~     management programme and usual care), and group 4 (comparison group 2: five weekly sessions~     of online mindfulness training programme and usual care). Subjects will complete~     questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor~     Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment~     Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence~     Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at~     baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and~     at 24 weeks from baseline by an online system or printed questionnaires. Individualised~     semi-structured interview (15-25 mins) for experimental and comparison groups will be~     conducted at 24 weeks from baseline to understand the subjects' experiences of the study~     programme. Data will be analysed using SPSS version 24. Baseline demographic and clinical~     information of subjects in the experimental, comparison and control groups will be~     summarised using descriptive statistics, and will be compared using chi square tests and~     ANOVA/ANCOVA tests. Intention-to-treat approach will be used. Repeated measures analysis of~     variance will be used to examine the differences on outcome measures among the experimental,~     comparison and control groups across study time points. In addition, differences in changes~     in outcome measures among experimental, comparison groups and usual care groups will be~     tested using multilevel modelling techniques. A p-value smaller than 5% will be considered~     as statistically significant. Content analysis will be conducted to analyse the interviews~     data.~   "
9580|NCT02931851|"~     Relatives in intensive care units (ICU) are important partners in decision-making in the~     treatment of critically ill patients and provide a significant resource in the care and~     recovery of patients. Therefore, a professional, educational intervention targeting these~     caregivers may have fundamental benefits with little risk. As in other fields, information~     is searched in the internet, but this unselected information is often overwhelming and of~     little use in this context.~      Symptoms of anxiety, stress and depression are common in affected relatives. The majority of~     family members report some level of anxiety, depression and stress, sometimes even resulting~     in post-traumatic stress disorder (PTSD). Importantly, an association between lack of~     information and post-traumatic stress disorder PTSD has been reported. The large number of~     potentially affected families poses a particular challenge to healthcare and may cause~     substantial secondary costs to national economy.~   "
9581|NCT02931838|"~     A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis~     treated with BMS-986165~   "
9582|NCT02931825|"~     Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank~     third with 43000 new cases in 2015. French Health Authority recommended colonoscopy~     screening for people with a high risk for colorectal cancer. But this compliance with~     colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve~     compliance.~      The purpose of this project is to to offer and evaluate the feasibility and the~     effectiveness of a specific surveillance system for high risk people for colorectal cancer~      The project will be divided into 2 phases:~      Objectives of the first phase:~        -  Identify high risk people for colorectal cancer in the department of Indre-et-Loire,~        -  Fill in as completely as possible their colonoscopic history in the past 5 years,~        -  Estimate the proportion of high risk people for colorectal cancer in the target~          population for colorectal cancer screening in Indre-et-Loire (Men and women aged from~          50 to 74 years).~      Objective of the second phase:~      Compare the performed colonoscopy rate of high risk people for colorectal cancer without~     notion of colonoscopy in the past 58 months following or not (control group) the sending of~     a letter reminding the importance of compliance with colonoscopy.~   "
9583|NCT02931812|"~     This study evaluates the influence of the taste sensitivity, of food preferences and of the~     reward system on the energetic balance before and after liver transplantation in cirrhotic~     patients and after kidney transplantation in renal failure patients~   "
9635|NCT02931136|"~     The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to~     investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to~     research completely independent intellectual property rights neuropsychological test tool~     for the MCI due to AD. At the same time, the investigators will study the efficacy and~     safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.~   "
9584|NCT02931799|"~     Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an~     increased risk of repeat hospitalizations within the same calendar year. Given that hospital~     readmissions represent a significant burden to patients and the health care system, a~     standardised pathway for IBD patients discharged from the hospital can have a significant~     impact on reducing readmission rates, healthcare utilization and patient satisfaction. The~     primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway,~     involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD~     readmission rates.~   "
9585|NCT02931786|"~     Investigators researched the effect of two different types of drugs on core body temperature~     during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation~     is not as distinct as in propofol group, due to its positive effect on thermo regulation~   "
9586|NCT02931773|"~     The investigators are studying the initial autonomic alterations in participants recently~     diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the~     baroreceptor sensitivity and on the peripheral sympathetic innervation.~   "
9587|NCT02931760|"~     Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to~     subcutaneous placement.~      Patients will be randomized (approximately half i each group) to receive the pacemaker~     device either subcutaneously (current practise) or intramuscular)~   "
9588|NCT02931747|"~     The purpose of this study is to determine the effect of Bacopa Monnieri on working memory~     and cognitive processing in student.~   "
9589|NCT02931734|"~     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,~     evaluate the various types of protocols and clinical efficacy in the reduction or even~     elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental~     Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil,~     Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the~     association of all products. Data will be collected, tabulated and submitted to statistical~     analysis.~   "
9590|NCT02931721|"~     Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential~     differences depending on the outcome, ie. sperm recovery in consequent microdissection~     testicular sperm extraction (MD-TESE).~   "
9591|NCT02931708|"~     Heart failure is an incapacity to provide adequate blood flow to the others organs, such as~     brain, liver and kidney. The patients presents weakness and fatigue of inspiratory muscles,~     mainly diaphragm muscle, that contributes to dyspnoea and limited physical capacity in this~     patients.~      Some methods are being studied to decrease the diaphragm weakness. The diaphragm functional~     eletrical stimulation is a new technique, which has been studied to improve the respiratory~     muscle strength. Then, the aim of this study is to assess the effects of diaphragm~     functional electrical stimulation (FES) on respiratory muscle strength and muscle~     architecture of patients with heart failure.~      For this the following assessments will be performed before and after stimulation:~     manovacuometry to verify the maximum inspiratory pressure and maximum expiratory pressure;~     and ultrasonography to assess muscle architecture.~      The subjects will be selected by the decompensation in heart failure, with the adequate~     elegibility criteria. This study have no control group, because this technique has been~     little researched and could be unethical with the patient who won't receive this treatment.~      The subjetcs of this research will receive the diaphragm functional electrical stimulation~     twice of day for consecutive five days or until the hospital discharge.~      Expected results at the end of the protocol with Diaphragm Functional Electrical Stimulation~     are: to improve respiratory muscle strength; to correlate with diaphragm muscle arquiteture.~   "
9592|NCT02931695|"~     QT interval prolongation, corrected for heart rate (QTc), either spontaneous or~     drug-induced, is associated with an increased risk of torsades de pointes and sudden death.~     Women are at higher risk of torsades de pointes, particularly during post-partum and the~     follicular phase.~      The aim of this study is to explore if QTc duration is prolonged during post-partum as~     compared to the 3rd trimester of pregnancy~   "
9593|NCT02931682|"~     With only limited prospective longitudinal data currently available on Creatine Transporter~     Deficiency (CTD), its natural history is at present incompletely understood. This~     international study is designed to provide additional insights into disease progression, to~     characterize how patients perform on clinical neurodevelopmental assessments, and to~     evaluate magnetic resonance spectroscopy (MRS) and event-related potentials (ERPs) in~     patients with CTD.~   "
9594|NCT02931669|"~     The perception of disability has changed throughout history, and today, people who~     previously did not have a way to communicate are able to express themselves through~     Augmentative and Alternative Communication (AAC). However, the potential of AAC is not being~     fully realised and devices are often abandoned. It is therefore essential to hear the voice~     of those who use it and those who interact with them on a daily basis, in order to find out~     what the meaning, value and purpose of AAC is for them. This will support SLTs in directing~     intervention and establishing priorities, as well as in advocating for funding and~     acknowledging the voice of AAC users. The study uses a qualitative descriptive approach,~     using thematic analysis to establish emerging themes from surveys completed by AAC users,~     family members, health professionals, teachers, and face to face interviews with children~     who use AAC.~   "
9595|NCT02931656|"~     Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with~     adverse perinatal outcomes and high risk for chronic disease both for the mother and for the~     child. Physical exercise is feasible to diabetic pregnant women and contributes to a better~     glycemic control and to decrease adverse perinatal outcomes. However there are no studies~     assessing the effects of aquatic physical exercise on GDM control.~   "
9596|NCT02931643|"~     This study aims to investigate the effect of mixed of herbs and spices on gene expression of~     pathways associated with glucose homeostasis, oxidative stress, inflammation and its~     interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.~   "
9636|NCT02931123|"~     This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy~     with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS~     hepatic encephalopathy.~   "
9943|NCT02927106|"~     In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity~     assays will be utilized to define clinically relevant gene mutations and identify potential~     therapeutics for patients with acute myeloid leukemia (AML).~   "
9597|NCT02931630|"~     The prevalence of overweight and lifestyle related diseases such as cardiovascular disease~     (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a~     condition characterized by abdominal obesity, high blood lipids, high blood pressure and~     elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D.~     Dietary fibers and whey protein have independently shown beneficial effects on several of~     these risk factors in previous studies. Whey protein is furthermore seen to show positive~     effects on bone turnover.~      The purpose of this trial is to investigate whether an increased intake of dietary fibers~     and whey protein (separately or combined) over a period of 12 weeks will affect the risk~     markers of MeS and bone turnover in abdominally obese subjects.~      A total of 80 people with abdominal obesity will be included. The design is a randomized,~     double blinded, controlled dietary intervention trial. Subjects are assigned to one of four~     experimental groups. Each group are provided with test products containing either high or~     low whey protein and high or low dietary fibers to replace part of their regular diet. The~     subjects are instructed in how to incorporate the test products in their habitual diets in~     order to maintain weight stability.~      The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of~     developing CVD. PPL is estimated by performing a standardized high fat meal test during~     which postprandial level of triglycerides is measured. The authors hypothesize that a diet~     of high content of whey protein and high dietary fiber during 12 weeks will induce a~     reduction in PPL.~   "
9598|NCT02931617|"~     Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients~     undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery~     (lobectomy etc, open or VATS) and cardiac surgery~   "
9599|NCT02931604|"~     The purpose of this study is to clinically evaluate sinus wash device prototypes in patients~     with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient~   "
9600|NCT02931591|"~     This study is aimed to determine if Metformin treatment in children born small for~     gestational age (SGA) who are being treated with Growth Hormone (GH) for short stature~     improves the response to GH by producing greater concentrations of Insulin-like growth~     factor -1 (IGF-1) in the blood.~   "
9601|NCT02931578|"~     The purpose of this study is to determine the glycemic index of commonly consumed~     sweeteners.~   "
9602|NCT02931565|"~     The objectives of this study are as follows:~      In patients with primary Type II Achalasia, following a single 5-mg dose of IW-1701,~        -  To assess the safety and tolerability~        -  To determine the effects on measures of esophageal function by high-resolution~          impedance manometry (HRIM)~        -  To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast~   "
9603|NCT02931552|"~     The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II)~     cognitive-behavioral stress management program through a 6-month RCT with 150~     Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving~     quality of lie (QoL) and reducing distress, compared to a usual care control group (that is~     offered the program at the end of the 6 months). We will test also the effects of the~     program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from~     saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver~     the stress management program in-person to Spanish-speaking Latinas with breast cancer.~   "
9604|NCT02931539|"~     The purpose of this study is to determine if an investigational treatment (Maribavir) is~     safe and effective in treating transplant recipient patients with cytomegalovirus (CMV)~     infections that are refractory or resistant to treatment.~   "
9605|NCT02931526|"~     The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of~     tigecycline in critical ill patients undergoing continuous renal replacement~     therapy（CRRT）and examine whether the dosage needs adjustment.~      The study will observe two groups of patients respectively and compare the difference~     between them. Patients who need to receive CRRT when treat with high-dose tigecycline will~     be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be~     collected in Group non-CRRT.~   "
9606|NCT02931513|"~     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by~     destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first~     line treatment for patients with PBC. However, up to 40% of patients respond inadequate to~     this treatment.~      sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver.~     sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and~     sMR can predict response to treatment with UDCA in newly diagnosed patients with PBC.~   "
9607|NCT02931500|"~     To develop machine learning algorithms for the identification of future development of~     cardiovascular and metabolic disease~   "
9608|NCT02931487|"~     Selective biases in attention can be modified by a simple computerized technique: The~     Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be~     one reason depression recurs, and altering these biases should reduce risk of recurrence.~     Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not~     well understood. More research is needed to explore how altering an implicit attentional~     bias can lead to changes in subjective mood. One possible explanation is that positive~     attentional biases are an important component of explicit methods of emotion regulation. The~     ability to effectively regulate one's emotions is a fundamental component of mental health~     and this ability is impaired in depression. It has also been shown that recovered depressed~     people spontaneously show a more dysfunctional pattern of emotion regulation as compared to~     never depressed controls. Supporting this, growing evidence implicates dysregulation of a~     medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal~     cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial~     thalamus. Components of this circuit are reciprocally connected with the amygdala, which is~     implicated in emotional processing in the healthy brain and dysregulated in depression.~     Negative emotion processing biases depend on both enhanced bottom-up responses to~     emotionally salient stimuli and reduces top-down cognitive control mechanisms, required to~     suppress responses to emotionally salient but task irrelevant information. Cognitive~     reappraisal and distancing are common strategies to down- or upregulate emotional responses.~     Reappraisal is an emotion regulation strategy that involves reinterpretation and changing~     the way one thinks about an event or stimulus with the goal of changing its affective~     impact. Distancing is a type of reappraisal that involves creating mental space between~     oneself and the emotional event in order to see things from a different, less self-focused~     perspective. It has been shown that distancing is a strategy that people can improve at over~     time compared to reinterpretation. The neural systems which support the explicit regulation~     of emotion have previously been characterized and include both lateral- and prefrontal~     cortex. This frontal activity is predicted to downregulate limbic circuitry involving the~     amygdala during passive viewing of emotional salient stimuli.~   "
9637|NCT02931110|"~     This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and~     cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics,~     and antitumor activity of CBL0137. The study will evaluate CBL0137 administered IV weekly on~     Days 1 and 8 of repeated 21 day treatment cycles in subjects with previously treated~     hematological malignancies.~   "
9609|NCT02931474|"~     Background:~      People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also~     alter hormones, which can cause poor sleep. Researchers believe that a form of growth~     hormone releasing hormone (GHRH) might improve sleep in service members and veterans who~     have had a TBI.~      Objective:~      To see if GHRH can improve sleep in people who have had a TBI.~      Eligibility:~      Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who~     have had a TBI in the past 6 months to 10 years.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube)~      Interview about their mood and alcohol and drug use~      Questionnaires about their TBI, mood, and sleep~      Participants will have 2 overnight study visits a couple weeks apart. These will include:~      Physical exam~      Urine sample~      Two intravenous catheters placed. Blood samples will be taken throughout the night.~      Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on~     the other.~      Spending the night in the sleep lab. Their brain waves will be recorded with electrodes~     placed on the scalp.~      A questionnaire in the morning about their sleep~      Participants will be called a few days after each overnight visit. They will be asked about~     how they are feeling and to rate their sleep.~   "
9610|NCT02931461|"~     The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core~     biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of~     the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus~     standard 22 gauge needle for diagnosis of lung cancer.~   "
9611|NCT02931448|"~     In France, the carbon monoxide is one of the first causes of the accidental poisonings with~     approximately 8000 cases a year, among which 500 deaths.~      The severe forms are translated by neurological disorders even a coma or the death straight~     away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate~     clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire~     corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its~     appearance and its gravity are not correlated in the gravity of the initial poisoning,~     however the precocity of the treatment tends to decrease its frequency.~      Carbon monoxide elimination is made under unchanged form in the expired air. In a~     spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in~     isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at~     23 minutes.~      This imposes a fast diagnosis for two reasons:~        -  For poisonings with low level, the more the investigators wait to measure the~          carboxyhémoglobine (HBCO), the more they risk not to detect it.~        -  The oxygen therapy decreases the duration of the poisoning and thus the tissular~          suffering.~      Actually the risk is important to pass next to the diagnosis and to let leave a patient~     without adapted care and without technical intervention to eliminate the source of the~     poisoning.~      Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO~     by realization of gas of the venous blood, which are taken in emergencies, but very often a~     few hours after the end of the exposure at the source of poisoning, what is translated by a~     disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005,~     MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate~     the carboxyhémoglobinémie in a not invasive way.~      Lot of studies showed the interest of its use in the early screening of carbon monoxide~     poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted~     care.~   "
9612|NCT02931435|"~     Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing~     prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and~     disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of~     knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in~     the United States alone. Many studies report rewarding outcomes for patients, but other~     research shows there are many patients that remain dissatisfied post-arthroplasty.~      The purpose of this study is to evaluate whether genicular radiofrequency ablation can~     relieve chronic post-arthroplasty knee pain.~   "
9613|NCT02931422|"~     The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a~     financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The~     study will evaluate 3 cash incentive values and determine percent uptake of testing. A~     post-test questionnaire will explore parental satisfaction, mechanisms of incentive~     effectiveness and the impact of testing on emotional health and pediatric healthcare~     utilization.~   "
9614|NCT02931409|"~     The purpose of this prospective randomized controlled trial is to determine the effects of~     intraoperative lung protective mechanical ventilation using an individual optimal PEEP value~     on postoperative pulmonary complications and inflammatory response. A total number of 40~     patients undergoing open radical cystectomy and urinary diversion will be enrolled and~     randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O~     will be performed in control group and an optimal PEEP value determined during a static~     pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study~     group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will~     be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery~     until the third postoperative day as well as postoperative pulmonary complications. Clinical~     condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure~     Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be~     followed.~   "
9615|NCT02931396|"~     The purpose of this study is to demonstrate the efficacy of FES for trans-tibial amputees.~     The investigators aim to demonstrate that providing three months of FES intervention will~     increase knee extension strength, increase volume of the residual limb and decrease chronic~     and phantom pain.~   "
9616|NCT02931383|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864).~     In the parent trial, patients will be subjected to an 8-week diet intervention phase~     including a low-calorie diet and dietetic counseling, after which patients will be~     randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to~     dietetic guidance on re-introducing regular foods and a focus on continued motivation to~     engage in a healthy lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of, joint~     inflammation and clinical symptoms, in obese patients with knee osteoarthritis following a~     randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
9648|NCT02930967|"~     A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand~     binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1~     positive tumors . In this single-arm, open-label, one center, dose escalation clinical~     study, the main purpose is to determine the safety and efficacy of infusion of autologous~     Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive,~     recurrent or metastatic malignant tumors.~   "
9617|NCT02931370|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counseling, after which patients will be randomised to~     receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic~     guidance on re-introducing regular foods and a focus on continued motivation to engage in a~     healthy lifestyle.~      This substudy aims to investigate any changes in Ultrasound (US) measures associated with~     the initial 8-week weight loss intervention.~   "
9618|NCT02931357|"~     This is a randomized, open label, parallel-groups, multicenter study. The study will be~     conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey~     flavour gel medical device class IIa.~   "
9619|NCT02931344|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).~      This substudy aims to investigate any changes in biomarkers associated with the initial~     8-week weight loss intervention~   "
9620|NCT02931331|"~     Regional absolute myocardial blood flow during stress (sMBF) as measured by Positron~     Emission Tomography (PET) improves post mechanical revascularization provided there is a~     baseline stress induced perfusion defect. Coronary revascularization performed on regions~     without a stress induced perfusion defect does not increase the sMBF.~   "
9621|NCT02931318|"~     In this descriptive study, the purpose was to determine the knowledge levels and attitudes~     of the people in Nevsehir, Turkey on organ donation.~      It has been determined that the people living in Nevsehir do not have sufficient knowledge~     on organ donation, they had various concerns on the issue, and they wanted to receive~     information from Organ Donation Units. It can be used the exemplification and~     internalization in educational curricula about increasing the organ donation.~   "
9622|NCT02931305|"~     The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a~     pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular~     disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each~     cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched~     controls.~   "
9623|NCT02931292|"~     Obesity is a chronic disease and its treatment requires close follow-up to accurately assess~     the efficacy and durability of any treatment strategy. It is widely accepted that bariatric~     surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes,~     and nutritional deficiencies.~      The study objective was to ascertain efficacy of weight loss and complication rates in 562~     consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.~   "
9624|NCT02931279|"~     Prospective, multicenter non comparative and observational study (post-market clinical~     follow-up).~      Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016~     and July 2017.~      The inclusion period will be 12 months and the follow-up 24 months~   "
9625|NCT02931266|"~     Prospective, multicenter non comparative and observational study (post-market clinical~     follow-up).~   "
9626|NCT02931253|"~     The purpose of this study is to see if the study drug metformin will help patients who are~     overweight and have atrial fibrillation. This study aims to see if metformin helps patients~     stay in normal sinus rhythm after a catheter ablation.~      Metformin is investigational for use in patients with atrial fibrillation. Metformin is~     approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes~     Mellitus. Metformin is used with a proper diet and exercise program to control high blood~     sugar, and has been shown to help people lose weight. This study aims to look at the effects~     of metformin on weight loss and heart rhythm in patients with atrial fibrillation.~   "
9627|NCT02931240|"~     A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System,~     with 2:1 study vs. active concurrent control group allocation ratio. This study will include~     126 patients of which 84 patients will be treated with the investigational device and 42~     patients will be included in an active control group.~   "
9628|NCT02931227|"~     Fifty two ICU patients over a 4-months period who required continuous temperature monitoring~     were included in the study, after informed consent.~      Interventions : All patients had esophageal temperature probe and a non invasive cutaneaous~     device, to monitor their core temperature continuously.~      Comparison to the esophageal temperature, considered as the reference in this study, used~     the Bland and Altman method with adjustment for multiple measurements per patient.~   "
9629|NCT02931214|"~     The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV~     doses of GMI-1359 in healthy adult subjects.~   "
9630|NCT02931201|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using~     the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease~     progression during chemotherapy or survival in DLBCL.~   "
9631|NCT02931188|"~     There are currently no studies evaluating the effect of anacetrapib on blood vessel function~     and stiffness of the arteries. The REVEAL-Vasc trial will assess whether anacetrapib, in~     addition to atorvastatin (LDL-C lowering drug) treatment, results in greater~     endothelial-dependent vascular function and aortic stiffness in patients with established~     cardiovascular disease, compared to adding placebo.~      Participants will be asked to provide a blood sample and pulse Wave Velocity/Pulse Wave~     Analysis and Flow Mediated Dilation will be carried out to assess blood vessel function and~     stiffness of the arteries. REVEAL-Vasc is an investigator led sub-study of HPS3/TIMI 55:~     REVEAL (Randomized Evaluation of the Effects of Anacetrapib through Lipid modification): A~     large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib~     among people with established vascular disease (NCT01252953) which is coordinated by OXFORD~     CTSU.~      No treatment will be received on this sub-study, therefore only participants who have been~     enrolled in HPS3/TIMI55 REVEAL in which participants received anacetrapib with atorvastatin~     or placebo will be considered for this trial.~   "
9632|NCT02931175|"~     The study aims to evaluate the potential role of ACTH gel in the management of~     non-infectious uveitis.~   "
9633|NCT02931162|"~     To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.~   "
9638|NCT02931097|"~     Gait and balance disorders represent the main motor disability in advanced Parkinson's~     disease. These symptoms are less or unresponsive to levodopa treatment and are considered to~     be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and~     freezing of gait are responsible for high morbidity (fractures, residential health care) and~     increased significantly mortality. The pathophysiology of gait and balance disorders is~     still poorly understood, but recent data obtained in animals and humans suggest that a~     degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the~     mesencephalic locomotor region, could play a crucial role. In line with this hypothesis,~     low-frequency stimulation of the pedunculopontine area, thought to increase the activity of~     the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance~     disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the~     mesencephalic locomotor region will be tested in 12 PD patients in a randomized,~     double-blind, cross-over, controlled study.~   "
9639|NCT02931084|"~     The natural course after ACL injury is not well described in the literature. Every year~     about 7000 people, a majority aged 15-30 years old, injure their anterior cruciate ligament~     (ACL) in Sweden. About 3500 go through surgical treatment and rehabilitation. Despite the~     large amount of research on ACL-injuries, there are still many patients who have~     unsatisfactory outcomes regarding instability, decreased activity level, and quality of~     life, not being able to return to sport as well as an increased risk for osteoarthritis. The~     general aim of the study is to evaluate the natural course and recovery after ACL injury.~     Specific aims:~        -  To evaluate physical, psychological and contextual factors affecting recovery after~          anterior cruciate ligament (ACL) injury. Recovery is related both to natural course and~          to treatment chosen~        -  To evaluate factors affecting the decision for which treatment to choose (ACL~          reconstruction and rehabilitation or rehabilitation alone)~        -  To evaluate factors affecting the decision for return to sports~        -  To study development of knee osteoarthritis after ACL-injury~        -  To study epidemiology of acute knee trauma~        -  To study risk factors for new injuries after ACL-injury These aims will be pursued by~          consequently and prospectively following patients who sustain a new ACL injury in a~          multicenter study including approximately 800 patients. Assessment methods will be~          questionnaires to patients, orthopedic doctors and physical therapists. A sub-cohort of~          130 patients will undergo multiple clinical and functional examination as well as MRIs~          and blood, urine and joint fluid samples.~   "
9640|NCT02931071|"~     Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and~     increased incidence of malignant tumors. The Project pursue the optimization of the~     collection of hematopoietic progenitor cells for later use in another clinical trial~     entitled Clinical Trial Phase I/II to evaluate the safety and efficacy of the infusion of~     autologous CD34+ cells mobilized with mozobil and filgrastim, and transduced with a~     lentiviral vector carrying the FANCA gene (Orphan Drug) for patients with Fanconi Anemia~     Subtype A . The objectives of this study are, therefore, to assess the safety and efficacy~     of CD34+ cells mobilization with mozobil and filgrastim, which is postulated the most~     efficient for the collection of CD34+ cells from FA patients.~   "
9641|NCT02931058|"~     The trial investigates the efficacy of knee-extension exercise prior to total knee~     replacement. The participants are randomly allocated to one of three exercise dosages. There~     is no control group.~   "
9642|NCT02931045|"~     Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors~     are essential for platelet activation. Antagonists against the P2Y12 receptor, which are~     established in secondary prevention of myocardial infarction, have unexplained~     anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced~     infection-related mortality compared to clopidogrel, previous standard treatment for~     patients with myocardial infarction. Activated platelets release pro-inflammatory and~     procoagulant platelet extracellular vesicles. The investigators assume that decrease in~     infection-related mortality in patients treated with ticagrelor may be explained by greater~     inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This~     study is expected to identify an additional mechanism of action of ticagrelor, which might~     contribute to the observed clinical benefits in patients treated with ticagrelor.~   "
9643|NCT02931032|"~     Oral diseases tend to be exacerbated due to delayed diagnosis. Patients avoid visiting their~     dentist even for regular checkups, and develop late stage disease, jeopardizing the~     treatment outcome. There is an urgent need for an inexpensive and minimally invasive~     technology that would serve as a diagnostic aid, allowing 1) efficient early detection and~     2) treatment customization. Diagnostic modalities based on the detection of volatile organic~     compounds in the exhaled air may answer this need.~      The proposed research aims at investigating signature molecular patterns of common oral~     diseases, as a first step toward the development of a computerized non-invasive diagnostic~     breath test, based on the Na-Nose device.~      The proposed research will be divided to three distinct stages. Stages 1-2 will serve for~     the detection and analysis of Volatile Organic Compounds connected with common oral~     diseases, and for the characterization of a specified diagnostic nano-receptor array. Stage~     3 will serve for the clinical testing of the array and as a proof of concept.~      In a pilot experiment, headspaces above colonies of S.mutans, S.sanguis, P.gingivalis and~     F.nucleatum were trapped and analyzed using Gas Chromatography Mass Spectrometry (GC-MS). A~     unique VOC signature, consisting of 20-35 molecules, was detected for each of the bacterial~     strains.~      These promising results allow the development of an algorithm for statistical detection of~     oral diseases by their VOC profile alone. Bacteria and distressed tissues emit unique VOCs,~     and additional research is required with other types and strains of bacteria - including~     cultivation of samples from active periodontal and carious lesions.~      The results of the proposed research may be revolutionary. A simple and non-invasive air~     sampling at home or in a drugstore will significantly increase patient compliance and~     curability rates, and decrease healthcare expenditure.~   "
9644|NCT02931019|"~     For better view of fiberoptic intubation, the posture of neck is compared between neck~     flexion and extension.~   "
9645|NCT02931006|"~     50 men will be recruited to this study. Participants will be asked to ingest commercially~     available bovine milk. Hormonal profile will be analyzed before and after consumption.~   "
9646|NCT02930993|"~     This is a single-arm, open-label, one center, dose escalation clinical study, to determine~     the safety and efficacy of infusion of autologous T cells engineered to express chimeric~     antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent~     or metastatic malignant tumors.~   "
9647|NCT02930980|"~     The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable~     device during different postures and activities and to understand the source of the sensed~     motion, in order to test feasibility for future enhancements in device functionalities.~   "
9651|NCT02930928|"~     The purpose of this prospective single center study is to investigate if the accuracy of~     length based body weight estimation by the already investigated algorithm (CLAWAR) can be~     improved by adding another parameter. For this study 500 patients are required to collect~     anonymized data (length, weight, age, mid upperarm circumference and patient habitus by~     visual estimation) for achieving a power of 80% during statistical analysis. The main~     hypothesis ist that CLAWAR's accuracy can be improved.~   "
9652|NCT02930915|"~     This study investigates the feasibility of using 3D-Printing to manufacture masks used to~     immobilize patients undergoing radiotherapy treatment for tumors affecting the head and~     neck.~   "
9653|NCT02930902|"~     The goal of this clinical research is to learn about the safety and tolerability of~     Keytruda® (pembrolizumab) in combination with paricalcitol, with or without standard~     chemotherapy in patients who have resectable pancreatic cancer. In this study, standard~     chemotherapy is the combination of Gemzar® (gemcitabine) and Abraxane® (nab-paclitaxel).~      Researchers also want to learn if giving the study drugs before surgery may help to control~     the disease. The safety of this drug combination will also be studied.~   "
9654|NCT02930889|"~     This is a investigator-initiated evaluation of the safety and efficacy of treating benign~     prostatic hyperplasia (BPH) by prostatic artery embolization.~   "
9655|NCT02930876|"~     Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895~     billion. Pharmacological treatments provide improvements in expected survival and symptoms,~     but at cost of a high rate of toxicities and increased time spent by patients away from~     their homes and families during treatment. This is particularly important for patients with~     advanced disease as the timeframe at stake relates to their last months of life.~      Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been~     widely reported as an important prognostic factor in advanced cancer, with impact on~     survival, toxicities, response to treatment and other patient-centered outcomes (such as~     functional capacity, quality of life and fatigue).~      Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in~     skeletal muscle mass and function. It was derived from the greek: sarx = flesh and penia =~     loss. In 2010, a European Consensus defined sarcopenia as a triad of muscle mass loss,~     decreased functional performance and muscle strength. It has been reported as a hallmark of~     cancer, with impact on prognosis, response to treatments, side effects of chemotherapy and~     recovery after surgery. The prevalence of sarcopenia in advanced cancer seems to vary~     according to gender, stage, primary tumor location and treatments, being present in about 28~     to 67% of patients.~      Exercise, in particular resistance training, is one of the most powerful ways of increasing~     muscle mass and evidence from elderly patients suggests that it is among the most promising~     interventions for sarcopenia. There is evidence that resistance training can be effective~     but evidence is still scarce for patients with advanced disease. Historically there have~     been some concerns regarding safety and efficacy for oncologic patients, and though evidence~     suggests that resistance training is one of the most preferred forms of exercise by~     patients, the effectiveness of resistance training alone on sarcopenia in patients with~     advanced cancer remains unknown. Another question is whether home (which seems to be the~     patients' preferred location for exercise) produces better results than hospital (the~     traditional location).~   "
9656|NCT02930863|"~     This study will evaluate the effectiveness of an automated voice prompting system on post~     operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to~     detect an improvement of the patient experience and provider care through a decrease in the~     number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own~     ability to follow the instruction and improve their SpO2 levels.~   "
9657|NCT02930850|"~     The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared~     to hemoglobin measurements obtained from a laboratory hematology analyzer.~   "
9658|NCT02930837|"~     To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours~     after onset of stroke symptoms in Chinese patients with acute ischemic stroke~   "
9659|NCT02930824|"~     Investigators will conduct a comparative effectiveness study of genotype-supported vs.~     conventional PPI dosing. Patients presenting with Gastroesophageal Reflux Disease (GERD) or~     dyspepsia symptoms and either 1) being initiated on proton pump inhibitor (PPI) therapy or~     2) with continued symptoms on current PPI therapy will be recruited from gastroenterology~     clinics and randomized to a genotype-supported versus conventional PPI therapy management~     strategy.~   "
9660|NCT02930811|"~     Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million~     people around the world and about 7 million people in France. Morbi-mortality from~     cardiovascular events is increased in this population. Intermittent claudication is the most~     common clinical feature of PAD.~      Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi~     type 5, is well tolerated, largely used in impotence and has interesting clinical delay and~     duration of action in the concept of a potential use in claudication.~      For patients agreeing and signing informed consent, randomisation of treatment~     (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual~     treatment. The experimental drug will be delivered for a 1 month treatment. First follow up~     visit at month one will focus on tolerance, compliance and eventual side effects. If no~     major side effect is found the study drug will then be delivered for an additional 2 months.~     Patients will be evaluated at month 3 (second follow-up visit) for persistent or~     non-persistent indication for revascularisation and addressed for revascularization if~     needed. In parallel focus on tolerance, compliance and eventual side effects will be done.~     If no major side effect is found, the study drug will be delivered for an additional 3~     months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of~     treatment) and month 9 (3 months after the end of experimental drugs).~   "
9661|NCT02930798|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
9662|NCT02930785|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
9663|NCT02930772|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
9664|NCT02930759|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
9665|NCT02930746|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
9689|NCT02930434|"~     The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of~     Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD~     deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health~     risk in the inhabitants of Chilean Antarctica.~   "
9690|NCT02930421|"~     The primary aim of this clinical study is to investigate if pulmonary rehabilitation can~     increase exercise capacity and quality of life in dyspneic mild chronic obstructive~     pulmonary disease (COPD) patients.~   "
10431|NCT02920710|"~     There is a need for a more reliable, expeditious therapy that can be used as an alternative~     to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to~     provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information~     about its safety and tolerability~   "
9666|NCT02930733|"~     Serratus plane block was first described in 2013 by Blanco and designed to primarily block~     the thoracic intercostal nerves. And this block provides sufficient analgesia lateral~     anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for~     regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by~     Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application~     and less adverse effects than neuroaxial blocks, has been defined after these blocks and has~     taken its place in the literature.In spite of the insufficient randomized clinical trials in~     the literature, SPB has been reported for many cases such as thoracoscopy, shoulder~     arthroscopy, breast surgery and axillary lymph node dissections, and the results are~     promising. The aim of this study is to determine effectiveness of ultrasound guided~     bilateral serratus plane block in patients undergoing breast reduction surgery.~      Main outcome measures: The primary endpoint is postoperative opioid consumption.~      Secondary endpoints are visual analogue pain scores, opioid related side effects.~   "
9667|NCT02930720|"~     Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to~     urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about~     25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and~     obstetric history. SUI is the complaint of involuntary leakage on activities which involves~     inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic~     floor movement is coordinated with the diaphragm, it moves caudally while inhaling and~     cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic~     floor is correlated to pelvic floor normal and efficient function. in order to maintain~     continence while internal abdominal pressure rises the pelvic floor as to work in a precise~     trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound~     (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement~     and function.~   "
9668|NCT02930707|"~     Major abdominal surgeries are associated with severe abdominal pain, which can affect~     respiratory and cardiac functions, if insufficiently managed. This increases the incidence~     of post-operative morbidity.~      The objective of this study was to detect the efficacy and safety of magnesium sulphate as~     an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in~     patients undergoing total abdominal hysterectomy.~   "
9669|NCT02930694|"~     The primary purpose of the study is to investigate the plasma pharmacokinetics and~     bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths~     of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of~     JNJ-54175446 under fasting conditions.~   "
9670|NCT02930681|"~     Glucosanol had previously been proven to be effective in aiding weight loss and weight loss~     maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was~     effective in aiding weight loss and also has evidence on reducing post-prandial glucose~     levels. This study is to enrich the existing evidence on dose-dependent post-prandial~     glucose effects of Glucosanol~   "
9671|NCT02930668|"~     It was proven in a previous clinical study that Glucosanol™ is effective and safe in~     reducing weight in the overweight and obese. The present study aims at expanding the data~     concerning the weight management effect of Glucosanol™ in overweight and moderately obese~     population.~   "
9672|NCT02930655|"~     The primary purpose of this study was to assess the safety and tolerability of lucerastat in~     adults with Fabry Disease receiving Enzyme Replacement Therapy (ERT).~      The secondary objectives were to investigate the effects of lucerastat on plasma and urine~     levels of biomarkers, to assess its effects on renal and cardiac functions and to determine~     the pharmacokinetic profile of lucerastat at steady-state.~   "
9673|NCT02930642|"~     The objective of this study is to determine the relations among food insecurity status,~     obesity, and impulsive food choice patterns and to test the extent to which a mindful eating~     strategy reduces impulsive choice for food. The central hypothesis is that food-insecure~     individuals will demonstrate more impulsive food choice patterns and demonstrate a greater~     likelihood of obesity than individuals who are food secure. Two specific aims are proposed:~      Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food~     choice patterns in women. The working hypothesis is that food-insecure individuals,~     especially those that are obese, will exhibit more impulsive food choice patterns than~     food-secure individuals.~      Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on~     impulsive choice patterns among food insecure women. The working hypothesis is that mindful~     eating will reduce impulsive food choice patterns relative to baseline and control~     conditions, and will persist to follow-up. The investigators expect mindful eating to reduce~     impulsive choice compared to control conditions, despite food security status.~   "
9674|NCT02930629|"~     The purpose of this study is to assess the incidence of residual block in patients arriving~     in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received~     neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function)~     due to residual levels of muscle relaxants is associated with increased morbidity.~   "
9675|NCT02930616|"~     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.~     Precisely surveillance of patients with GIM may result in early detection and improved~     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all~     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%~     in those patients.~   "
9676|NCT02930603|"~     A Longitudinal Study of Function and Participation in Life Activities of Patients with~     Developmental Disabilities~   "
9691|NCT02930408|"~     Steinert's disease is an orphan disease. The prognosis of patients with this disease is~     conditioned by cardiac involvement. Search an early stage alterations in contractile~     function in subjects suffering from dystrophy would detect patients at risk of sudden death.~     The first stage of work is to validate the tools to detect early stage of infringement~     systolic function in a population of patients with myotonic dystrophy.~   "
9735|NCT02929836|"~     This randomized prospective study compared three ablation strategies in patients with~     longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural~     endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left~     atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial~     electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation~     +CFAE ablation, and PVI+CFAE ablation.~   "
9677|NCT02930590|"~     Pressure ulcers are severe injuries and wounds causing a substantial burden on patients,~     caregivers, and on healthcare systems worldwide. There is common agreement, that effective~     pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in~     individuals at risk. Besides risk assessment and repositioning the use of special pressure~     ulcer preventive support surfaces are the key interventions in pressure ulcer prevention.~     Pressure ulcer preventive support surface modify the degree of skin and tissue deformation~     and/or skin temperature and moisture. Therefore, an association between the type and working~     mechanism of a pressure ulcer support surface and skin function after loading is highly~     likely. Furthermore, such a relationship may be used to characterize and/or to quantify the~     performance pressure ulcer support surfaces in terms of skin protection. The overall aim of~     this explorative study is to measure skin responses of the two most common pressure ulcer~     predilection sites (heel, sacral skin) after two hours loading on three different support~     surfaces and the sternal skin (control area).~   "
9678|NCT02930577|"~     This study evaluates the factors associated with treatment adherence in substance users.~     Differences in the level of adherence to treatment according to patient-related factors,~     addiction and treatment are analyzed. The individual effect of each factor on treatment~     adherence is assessed.~   "
9679|NCT02930564|"~     The Challenge study is a prospective, open label, pilot trial in patients in deep remission~     on dietary maintenance therapy.~      The purpose of this study is to determine whether they can consume some of the products that~     were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to~     evaluate if low dose exposure is harmful.~   "
9680|NCT02930551|"~     Neuromas are frequent after trauma and surgery, including amputation and can be identified~     by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is~     uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will~     be relieved by injection of local anesthetics near painful neuromas in subjects with~     peripheral nerve injury.~   "
9681|NCT02930538|"~     The proposed research will determine whether a 6-item screening questionnaire previously~     shown to correlate with moderate or severe OSA is useful for predicting postoperative~     outcomes in children undergoing surgery under general anesthesia.~   "
9682|NCT02930525|"~     Procedural sedation is an established and safe intervention and is widely used in diagnostic~     and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory~     system such as upper airway obstruction, hypoventilation and apnea are frequent adverse~     events. We postulate that respiratory instability is less frequent in patients high flow~     nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in~     pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of~     HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper~     gastrointestinal endoscopy under pediatric procedural sedation (PPS).~   "
9683|NCT02930512|"~     Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk~     of fracture, particularly hip fracture whose complications and postoperative mortality~     appear to be higher than in the general population.~      This increased risk of fracture is due partly to an increased risk of falling, and secondly~     to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis~     concluded that patients with IPD have lower BMD than healthy controls. Prospective studies~     also showed rapid bone loss in these patients compared with controls. The association~     between low BMD and IPD seems dependent on the severity and duration of the disease even if~     some data are contradictory. Various mechanisms may explain this bone loss including weight~     loss, malnutrition and a low level of physical activity. However, enrollments in these~     studies are often weak and it is difficult to conclude on the real impact of these factors~     on bone loss in the IPD. The main objective of our study is to assess and prioritize from~     these various bone loss mechanisms. Bone assessment by peripheral quantitative computed~     tomography (pQCT) will also assess the impact of various risk factors on bone strength~     parameters. The prevalence of vertebral compression fractures in the IPD, at this day~     unknown can be evaluated. This study will also estimate the prevalence of vertebral~     compression fractures in the IPD.~   "
9684|NCT02930499|"~     The purpose of this pilot study is to compare the incidence and rate of wound healing in~     subjects with venous ulcers treated with an extracellular matrix wound dressing composed of~     hyaluronic acid plus compression therapy as compared to standard care. The study also~     intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence~     within treatment groups.~   "
9685|NCT02930486|"~     Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight~     suture endobutton and one tricortical 3,5 mm syndesmotic screw.~   "
9686|NCT02930473|"~     This study aims to evaluate the effectiveness of a psychotherapeutic intervention model in~     nursing for the nursing diagnosis Anxiety. A pilot randomised controlled trial will be~     carried out to testing procedures for their acceptability, estimating the likely rates of~     recruitment and retention of subjects, and the calculation of appropriate sample sizes.~     Moreover, this pilot study aims to test hypotheses.~   "
9687|NCT02930460|"~     Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel~     Positive Airway Pressure: AirCurve 10 VAutoTM~   "
9688|NCT02930447|"~     Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in~     plastic surgery. However, only pilot studies and retrospective uncontrolled trials have~     reported the potential benefits of autologous glue treatment up to now. Therefore, a larger,~     blinded, randomized and placebo-controlled clinical trial would be useful to determine~     whether platelet-rich plasma is safe and effective in abdominoplasty procedures.~      Currently, there are pharmacological options such as artificial fibrin glues composed of~     homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a~     risk of transmissible diseases and may induce allergic reactions. Therefore, autologous~     glues, which are fully made of blood components from the patient itself (autologous~     fibrinogen contained in PRP and autologous thrombin) represents a safe alternative to~     artificial biological glues.~      Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an~     autologous activated thrombin serum, on the other hand, in a safe and rapid manner.~     RegenKit®-Surgery is a CE-marked class IIb medical device.~      This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared~     with RegenKit®-Surgery when used in reconstructive abdominoplasty.~   "
9692|NCT02930395|"~     In the past 20 years, the incidence of concussion in direct contact sports has significantly~     increased. The incidence of concussion in rugby players ranges between 8 to 17 episodes /~     1000 playing hours. A recent study published by the French Rugby Federation (FFR) and the~     National Rugby League (LNR) showed similar results. The latter study was performed analyzing~     the French TOP14, which includes 14 teams participating in professional rugby~     championships. At least two concussions were diagnosed each week. Despite the recent~     evidence, cognitive assessment remains the only means to determine whether or not players~     experiencing concussions can return to the game or not.~   "
9693|NCT02930382|"~     We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years~     after myocardial infarction (MI) in primary prevention.~      Only the ejection fraction of the left ventricle (LVEF) is used as a tool for risk~     stratification of sudden death after myocardial infarction.~      Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after~     MI was predictor of sudden death.~   "
9694|NCT02930369|"~     The purpose of this study is to determine the effects of two different internal limiting~     membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery~     measured by optical coherence tomography (OCT).~   "
9695|NCT02930356|"~     This study is intended to measure hepatocyte growth factor levels in smokers and non smokers~     with periodontitis before and after non surgical periodontal therapy.~   "
9696|NCT02930343|"~     RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in~     destructive arthritis if not treated rapidly. Inspite of various advances in field of early~     diagnosis and treatment of RA, there is still a need for better understanding of the~     efficacy and safety of various combinations of conventional DMARDS, and to rank them in~     order accordingly, so as to give a clearer vision for further management of RA once MTX~     monotherapy fails, so as to achieve remission as soon as possible. The study will be~     conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of~     Postgraduate Medical Education & Research). patients who fail methotrexate monotherapy will~     be randomised to 2 treatment arms - either a combination of Sulfasalazine (SSZ),~     Hydroxychloroquine (HCQ) and Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine~     (HCQ) and Methotrexate (MTX)~   "
9697|NCT02930330|"~     The purpose of this study is to determine whether high intensity interval training (INT) is~     more effective in suppressing platelet reactivity than continuous, moderate intensity~     training (CONT) in patients undergoing cardiac rehabilitation after percutaneous coronary~     intervention.~   "
9698|NCT02930317|"~     Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia~     A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy~     in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia~     A. To determine the pharmacokinetic (PK) parameters of rFVIII.~   "
9699|NCT02930304|"~     Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is~     considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the~     forearm, especially extensor carpi radialis brevi.~      The aim of this study is to The compare the short-term effects of different physiotherapy~     approaches on pain, function and grip strength in the rehabilitation of patients with~     lateral epicondylitis.~   "
9700|NCT02930291|"~     The purpose of this study is to explore the effect of preoperative inflammation-based scores~     on postoperative morbidity and mortality for laparoscopic gastrectomy.~   "
9701|NCT02930278|"~     The purpose of this study is to explore the effect of preoperative hemotologic markers on~     postoperative long-term and short-term outcomes for laparoscopic gastrectomy.~   "
9702|NCT02930265|"~     It has been known that liraglutide reduces infarct size, improved left ventricular function,~     reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion~     injury for patients with acute myocardial infarction. But it is not sure whether liraglutide~     can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of~     Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.~   "
9703|NCT02930252|"~     The purpose of this study is to compare the duration of stent patency of a covered vs. an~     uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction~     in patients with inoperable extrahepatic malignant biliary obstruction.~   "
9704|NCT02930239|"~     A randomized control trial where subjects following an anterior cruciate ligament~     reconstruction will be randomized to either a control group who will receive the normal~     rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using~     the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will~     be added to the existing care received at Linkoping University Hospital 2 weeks~     post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a~     3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a~     clinical examination.~   "
9705|NCT02930226|"~     Assess the safety of single infusions with RePlas FDP product at increasing fixed doses~   "
9706|NCT02930213|"~     In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients~     were measured every 2 hour for 168 h .~   "
9707|NCT02930200|"~     The primary long-term objective of this research is to reduce smoking relapse through the~     use of automated mobile smoking cessation interventions that tailor content (e.g., treatment~     messages/materials) in real-time based upon currently present symptoms. The primary~     short-term objective of this pilot study is to determine the initial utility of a novel~     smartphone based smoking cessation intervention compared with standard in-person smoking~     cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking~     cessation application. The current pilot study is a 3 armed randomized clinical trial that~     aims to determine the initial utility of a novel smartphone based smoking cessation~     intervention compared with standard in-person smoking cessation clinic care and the free NCI~     QuitGuide smoking cessation application.~   "
9708|NCT02930187|"~     Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3),~     PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI~     and ACR-EULAR criteria for remission in routine care.~   "
9709|NCT02930174|"~     This study is being done to further the investigators' knowledge of the EIT system and to~     see if measures between two non-invasive ventilation systems routinely used clinically are~     equivalent.~   "
9711|NCT02930148|"~     the aims of the present study is to test the PEGASO system in real life conditions in~     Lombardy (Italy), England and Scotland (UK) and Catalonia (Spain), as well as to assess~     changes in teen-agers' awareness and lifestyles after the use of PEGASO system.~     Specifically, the investigators aim to:~        1. To test the usability of PEGASO platform~        2. To pilot approaches to testing the effectiveness of the system to:~             1. Evaluate the increase of knowledge/awareness about healthy habits~             2. Assess behavioural change in lifestyle, and specifically on target behaviours In~               particular, the pilot study will help to assess likely recruitment and retention~               in a controlled trial, to test the acceptability and utility of assessment~               procedures, to obtain estimates of effect size and variability to power a future~               substantive study~   "
9712|NCT02930135|"~     The aim of this study is to compare the clinical and radiographic success of indirect pulp~     capping of vital young permanent teeth with deep caries using two-step antibacterial bonding~     system versus conventional one.~   "
9713|NCT02930122|"~     Injury to the knee during sports participation often involves partial or full detachment of~     the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and~     inflammation. While the swelling and inflammation usually goes away in time, individuals~     with ACL injuries may experience pain and notice knee instability (knee slipping, etc.).~     Often surgery can repair or replace the ACL within the joint, allowing individuals the~     ability to walk or run again pain free or participate in sports. Unfortunately,~     osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee~     10-20 years later for reasons which are not well understood.~      In this research study, the investigator hopes to reduce the initial pre-operative pain. The~     reduction of pain will allow for earlier movement of the knee joint and preparation for~     surgery. The investigator is interested to see if the use of Kineret does decrease the risk~     of developing arthritis in individuals with ACL injuries by treating them within 1-7 days~     after their injury.~   "
9714|NCT02930109|"~     A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of~     relapsed or refractory acute leukemia.~   "
9715|NCT02930096|"~     To evaluate the pulsatility index changes after setting supine position in non brain-~     injured patient under general anesthesia.~   "
9716|NCT02930083|"~     To improve activities of daily living (ADL) and social functions is the important treatment~     plans and goals in participants with schizophrenia. Precise and effective measures of ADL~     and social functions are critical for clinicians to set up appropriate treatments plans,~     follow up participants' changes, and understand participants' progress. Three common~     measures of ADL and social functions used in participants with schizophrenia were the~     Comprehensive Occupational Therapy Evaluation Scale (COTES), the Activities of Daily Living~     Rating Scale third ed. (ADLRS-3), and the Social Functioning Scale. To investigators'~     knowledge, psychometric properties of these assessments have not been examined in~     participants with schizophrenia. Therefore, the purpose of the study is to (1) examine~     internal consistency and construct validity of these 3 assessments (the COTES, the ADLRS-3,~     and the Social Functioning Scale); and (2) calculate missing rate of self-report assessment~     (the ADLRS-3 and the Social Functioning Scale). Investigators expect that these results of~     internal consistency, construct validity and/or missing rate will provide empirical evidence~     for using these three measures in both clinical and research setting.~   "
9717|NCT02930070|"~     The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general~     wards. Despite an alternative process by using a simplified qSOFA score, many patients may~     still be left out. Whether these patients matter or not is unknown. This prospective cohort~     includes patients from ten general wards with high incidence of infection during a~     consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore~     to compare patients under different groups, eventually to evaluate the diagnostic accuracy~     of qSOFA score in diagnosis of sepsis.~   "
9718|NCT02930057|"~     The purpose of this study is to examine the potential changes in levels of pain, quality of~     life (QoL) and activities of daily living (ADL) observed when transforaminal epidural~     steroid injection is administered in conjunction with pulsed radiofrequency treatment of the~     lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring~     side effects) of the treatment is determined.~      The study hypothesis is that the application of transforaminal epidural steroid injection~     (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar~     dorsal root ganglion would increase the treatment response of PRF and thereby provide a~     measurable difference in the pain scores, quality of life and activities of daily living for~     the patients suffering from chronic lumbosacral radicular pain.~   "
9719|NCT02930044|"~     The purpose of this study is to determine whether adult DKA patients who present to the~     emergency department treated with early subcutaneous long acting insulin versus standard~     care receive a shorter total duration of intravenous (IV) insulin infusion.~   "
9720|NCT02930031|"~     In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to~     enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous~     eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations~     in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation~     may alter immune cell responses following exercise-induced muscle microtrauma.~   "
9721|NCT02930018|"~     The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the~     neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic~     stroke (AIS) with a small established infarct core and with good collateral circulation who~     are selected for endovascular revascularization.~   "
9722|NCT02930005|"~     This study evaluates the feasibility of administering meclofenamic acid or pentosan~     polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic~     disorder. Half of participants will receive meclofenamic acid, while the other half will~     receive polysulfate sodium.~   "
9736|NCT02929823|"~     The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective~     in promoting corneal epithelial wound healing in conditions associated with corneal~     epithelial disorders.~   "
10458|NCT02920359|"~     The study consists of the generation of biological samples (in urine) positive to~     leuprorelin acetate for doping control by new developed methods, and establish the~     analytical parameters that reveal the administration of Leuprorelin acetate in healthy~     volunteers with these methods.~   "
9723|NCT02929992|"~     The investigators propose the Delivery Optimization for Antiretroviral Therapy Study - The~     DO ART Study - a prospective randomized study of strategies to optimize community-based ART~     initiation, monitoring and resupply among HIV-positive persons in South Africa and Uganda.~     The investigators will work closely with community members, stakeholders, local providers,~     and the local Department of Health (DoH) to integrate the community-based ART delivery with~     HIV clinics, pharmacies and labs. Following community sensitization, participants will be~     recruited through community-based HTC and HIV clinics. HIV-positive persons not engaged in~     care will receive point-of-care CD4 testing to determine ART eligibility. HIV-positive~     persons who are eligible for ART by national guidelines will be randomized to one of three~     ART delivery arms: (i) Home ART initiation and mobile van ART monitoring and resupply, (ii)~     Hybrid model with clinic ART initiation and mobile van ART monitoring and resupply, and~     (iii) Clinic ART initiation, monitoring and resupply - the current standard of care (SOC)~   "
9724|NCT02929979|"~     The project will examine whether a computerized neuroscience-based cognitive training~     program can improve cognitive functioning and recovery outcomes among Veterans with Alcohol~     Use Disorder and co-occurring PTSD. Information from this study will help determine the~     malleability of cognitive dysfunction, an established risk factor for poor recovery outcomes~     in this population. Improved functional outcomes can decrease risk of chronic impairment and~     ultimately help affected individuals live richer, more productive lives. Web-based treatment~     technologies may increase the reach and impact of treatment, and foster patient recovery in~     cases where staffing, space, acceptability of counseling, and transportation are barriers.~     Findings may also support expanding use of existing, highly-accessible cognitive remediation~     technologies to other vulnerable clinical populations.~   "
9725|NCT02929966|"~     The investigators will examine the effect of introducing palliative in patients with~     end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not~     deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators~     will randomly assign patients who receive either early palliative care integrated with~     standard respiratory care or standard respiratory care alone.~      Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome~     will be the change in the quality of life and symptoms at 12 months.~   "
9726|NCT02929953|"~     The aims of this study are:~        1. To assess the prevalence of prematurity, especially early prematurity, among T1D~          patients, and compare it to the prematurity prevalence among the non-diabetic general~          population in Israel.~        2. To characterize epidemiological and clinical factors that differ between premature-born~          patients that developed T1D and those that have not, including the nutritional and~          therapeutic properties in NICU.~   "
9727|NCT02929940|"~     Alpha1-antitrypsin deficiency (AATD) is the third most common genetic disorder leading to~     death worldwide. Apart from lung disease, AATD also leads to liver involvement in up to 50%~     of patients. Hence, liver involvement is the second most common cause of morbidity and~     mortality in AATD patients. But the natural history of disease in adults is not well~     understood and specific therapies are still in the phase of preclinical studies. Despite~     these facts and the therapeutic and preventative potential, the AATD-related liver disease~     is still largely being neglected by both the patients and the healthcare professionals.~      To improve the hepatologic care of patients with AATD, the investigators initiated a~     prospective multi-center study in Europe that systematically evaluates the liver function in~     these patients and their relatives. The investigators cooperate with both patient~     organizations as well as with lung centers specialized on AATD-related lung disease.~   "
9728|NCT02929927|"~     This study tries to collect clinical cases to compare the clinical effect of traditional~     root canal disinfection, to photodynamic in root canal disinfection .And provide the~     reference for clinical application and experience.~   "
9729|NCT02929914|"~     The aim of the proposed study is to assess the clinical effect of photodynamic therapy~     (PDT)using LED on dentin with carious lesions in permanent teeth. Patients with molars~     exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment~     will be randomly allocated to two groups: Group 1 -Control after incomplete caries~     removal,indirect pulp treatment with calcium hydroxide(CH); Group 2 - PDT + CH after~     incomplete caries removal,disinfect the residual dentin with PDT(LED + methylene),then~     indirect pulp treatment with CH. Dentin samples will be removed before and after PDT for~     microbiological analysis. The microbiological samples will be cultured in Brucella blood~     agar, Mitis Salivarius-bacitracin agar and Rogosa Selective Lactobacillus agar. The teeth~     will then be restored using resin with clinical and radiographic follow up at six, 12 and 24~     months. The data will be submitted to descriptive statistics.~   "
9730|NCT02929901|"~     The purpose of this study is to investigate the effects of coffee main constituents~     (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic~     steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two~     hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of~     four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2,~     caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group~     4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.~   "
9731|NCT02929888|"~     Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater~     pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute~     coronary syndrome. However, evidence is lacked about the effects of achieving faster and~     stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to~     oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy~     volunteers that the administration of intravenous LA resulted in a significantly reduction~     of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading~     dose of LA achieves platelet inhibition faster, greater and with less variability than~     aspirin. However, there are no data of this issue in patients with an ST-segment elevation~     myocardial infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus~     aspirin in platelet reactivity in patients with STEMI~   "
9732|NCT02929875|"~     In an experimental research, 100 nulliparous pregnant women who had referred to health care~     centers in Kermanshah were randomly selected and after taking Written Informed Consent~     letter, assigned into case and control groups. instruction based on TPB was provided just~     for the case group. Afterwards, post-test was taken by both groups and the results were~     analyzed.~   "
9737|NCT02929810|"~     Emerging evidence suggests that approximately 30% of the US adult population sleeps less~     than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop~     cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely~     voluntary, sleep deficiency can be corrected and its detrimental health consequences~     potentially reversed. The purpose of the present proposal is to investigate the~     cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1~     hypertensive subjects who report habitual short sleep.~   "
9738|NCT02929797|"~     A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the~     pancreatic cancer patients treated with adjuvant chemotherapy.~   "
9739|NCT02929784|"~     The purpose of the study is to investigate the possibility of treating Hemiplegic Shoulder~     Pain (HSP) using transcranial direct current stimulation (tDCS) in patients following~     stroke.~      The secondary aims are to see if this treatment affects motor function of the upper limb, to~     asses the different types of HSP and whether there is any correlation to the location and~     extent of the stroke.~   "
9740|NCT02929771|"~     This study will assess the impact of virtual reality (VR) in decreasing procedural pain~     related to subcutaneous port (SCP) access in children with cancer. The study is a~     pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with~     detailed information on the feasibility of implementing our trial protocol in a future~     multi-center RCT as well as preliminary estimate of VR treatment effect on children with~     cancer undergoing SCP access, including child and parent factors potentially associated with~     VR distraction treatment efficacy.~   "
9741|NCT02929758|"~     The purpose of this prospective, within-subject randomized cross-over design study is to~     determine if a computer training program (Speed of Processing Training - SOPT) improves safe~     pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a~     virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy~     older adults and patients with Parkinson's disease. Several age-related changes, including~     slowing of visual processing speed, increase risky pedestrian behavior. This study will~     determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and~     healthy older adults and evaluate the persistence of the SOPT training effects.~   "
9742|NCT02929745|"~     The purpose of this study is to understand how genetics play a role in psoriasis.~     Specifically, a genetic allele HLA-Cw6 is known to be assoicated with psoriasis, and this~     study aims to find out how it affects genetic and protein expression in patients with~     psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry~     and RNA-sequencing protocol.~   "
9743|NCT02929732|"~     Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common~     neurological sensorimotor disorder that typically impairs sleep and quality of life, likely~     consequent to a central dopaminergic dysfunction associated to brain iron deficiency.~     Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are~     often associated with micro-arousals that contribute to sleep fragmentation and repeated~     increases of blood pressure and heart rate throughout the night, thus representing an~     increased risk for hypertension and cardiovascular diseases (CVD).~      Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as~     advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous~     observational, cross-sectional or longitudinal population-based studies on the association~     between RLS and CVD and hypertension showed controversial results.~      While the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one~     theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons~     in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons,~     therefore a reduction in dopamine may in turn increase sympathetic outflow.~      Based on this notion, the investigators hypothesize an increase of sympathetic autonomic~     activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure~     and heart rate during sleep, which may play a role in increasing the risk of cardiovascular~     diseases.~      The aim of this study is to analyze the autonomic nervous activity in patients with WED~     compared to healthy volunteers controls. The investigators will measure primarily the~     cardiac sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy~     and secondarily the sympathetic nerve activity by the microneurography, the plasmatic pro~     inflammatory biomarkers and urinary catecholamine levels and the circadian variation of~     blood pressure and heart rate as assessed by the 24-hour ambulatory blood pressure~     monitoring.~   "
9744|NCT02929719|"~     Therapeutic equivalence and safety study~   "
9745|NCT02929706|"~     NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory~     bowel disease (IBD) cohort.The present study aim to explor the following questions:can~     optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is~     the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised~     controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine~     use and optimise dosage according to the genotype.While the subjects in the control group~     follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The~     secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.~   "
9746|NCT02929693|"~     The investigators performed a multi-centered, randomized, double blinded,~     placebo-controlled, prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction~     (YYJD), a chinese herbal medicine (CHM) formula combined with gefitinib to prolong the~     progression free survival (PFS) of advanced pulmonary adenocarcinoma patients with~     activating EGFR mutation (exon19del or exon21L858R). The investigators plan to enroll 198~     cases in 3 years (99 cases for gefitinib, 99 cases for gefitinib plus YYJD), expecting that~     combination therapy has a better efficacy on prolonging PFS, overall survival, improving~     quality of life(QOL).~   "
9747|NCT02929680|"~     The purpose of the Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract~     Infection (LRTI) Panel BioFire Study #DX-SDY-024947 is to collect data in support of the~     proposal to the FDA to support the classification of the LRTI panel as an in vitro~     diagnostic device for the diagnosis of lower respiratory tract infections. The study will~     enroll up to 1500 specimens across at least 3 study sites of sputum and bronchoalveolar~     lavage (BAL) specimens that are left over as excess from routine clinical care.~     Additionally, the study will collect residual whole blood or blood fractionation to evaluate~     the utility of procalcitonin (PCT) as an additional test to diagnose lower respiratory~     infection when it is available. Enrolled sputum and BAL specimens will be run on the~     FilmArray LRTI panel. If residual whole blood or blood fractionation is available it will be~     sent to BioFire Diagnostics, LLC where they will perform PCT testing. All specimens will be~     excess from routine standard of care testing.~   "
9791|NCT02929108|"~     The project will test the effect of educating and supporting caregivers of hospice cancer~     patients on their active participation in shared decision making in the plan of care for~     their patients.~   "
9748|NCT02929667|"~     Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some~     patients with epilepsy. It ranks second only to stroke among neurological diseases in years~     of potential life lost. Patho-mechanisms of SUDEP remain not well understood, however~     peri-ictal respiratory dysfunction likely plays an important role in many cases.~      Literature supports a critical role for the serotonergic system in central control of~     ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon~     dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as~     mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state.~     In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin~     reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators~     hypothesize that a subset of drug resistant epilepsy patients who have impaired central~     chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a~     higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve~     central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.~   "
9749|NCT02929654|"~     To investigate whether novel insight features in new BGMs can improve glycemic control.~   "
9750|NCT02929641|"~     When a polyp is found, it woulf be recorded by a white-light and OE1 model with~     magnification for assessing and predicting its histology. After that, its really histology~     will be reported by an pathologist.~   "
9751|NCT02929628|"~     Patients with an implantable electrical nerve stimulation system Patient criteria included:~     over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition＞2.0;an ability to~     walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore ＞1 for~     UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases~     such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials.~     Subjects participating in other clinical trials related or not related to these trials were~     not chosen.~   "
9752|NCT02929615|"~     The purpose of the study is to research the standard and individualized treatment model for~     relapse and refractory lymphatic system malignant tumors.~   "
9753|NCT02929602|"~     Opioid analgesics prescribed by dentists may contribute to the larger national issue of the~     use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the~     use of opioids. This study used both dentist and patient input to evaluate the use of opioid~     and over-the-counter analgesics following one of seven coded common dental procedures. The~     study includes a five day patient follow up assessment of the effectiveness of the~     analgesic. Baseline questionnaires were completed by eligible participants, and they~     responded to the day 5 follow up questionnaires.~   "
9754|NCT02929589|"~     This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing~     oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open~     unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid~     (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal~     fentanyl), which can be continued. The patients will not be allowed to continue any~     over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing~     medications, that were not prescribed by the investigators during this study. Patients not~     receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill~     will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the~     investigators nor the research subjects will know if the subject is receiving a placebo~     versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be~     followed for 2 months after their surgery. The research aims to discover the appropriate~     amount of opioid medication to prescribe to patients undergoing an elective open inguinal~     hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in~     combination. The investigators expect that the subjects who take ibuprofen will use less~     oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could~     contribute to reducing the surplus opioids prescribed by physicians after surgery, which can~     lead to opioid use disorders. This particular procedure is common in men, and the findings~     have the potential to decrease the symptoms and pain of Active Duty members and DoD~     beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug~     abuse or dependence.~   "
9755|NCT02929576|"~     The purpose of this study is to evaluate and compare the clinical benefit and safety of~     treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy~     versus placebo with paclitaxel in patients with locally advanced or metastatic,~     diagnostic-positive, triple-negative breast cancer (TNBC).~   "
9756|NCT02929563|"~     This study tests the feasibility of a large study of stress ulcer prophylaxis in critically~     ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to~     require mechanical ventilation for more than 48 hours will be randomized to intravenous~     pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical~     ventilation.~   "
9757|NCT02929550|"~     Methods: All patients <75 years registered in the Swedish Secondary Prevention after Heart~     Intensive care Admission registry (SEPHIA), will be followed-up within one year~     post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for~     recurrent cardiovascular disease (CVD) events and death will be used to estimate base case,~     and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of~     the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´~     Collaboration findings.~   "
9758|NCT02929537|"~     With the comparative effectiveness research methods and hospital registration study~     approach, the purpose of this study is to objectively record the methods, efficacy and its~     influencing factors of COPD commonly used treatment methods/programs (Western medicine,~     Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment,~     analysis of application characteristics for the different programs, and provide the basis~     for its revision and promotion. It is a first registration study for COPD in China.~   "
9759|NCT02929524|"~     Randomized clinical trial, controlled, double-blind, parallel two-arm.~   "
9760|NCT02929511|"~     In this study, the researchers will investigate the effect of reciprocating versus~     rotational movements during endodontics treatment on the postoperative pain in adult~     patients who have necrotic pulp and apical periodontitis.~   "
9761|NCT02929498|"~     This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity~     of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study~     consisted of 2 parts. The objective of Part 1 is to determine the recommended phase 2 dose~     (RP2D) of GSK2879552 administered alone and in combination with azacitidine in adult~     subjects with high risk MDS previously treated with HMA. The objective of Part 2 is to~     evaluate clinical activity after treatment with GSK2879552, alone or in combination with~     azacitidine, in adult subjects with high risk MDS previously treated with HMA.~   "
9762|NCT02929485|"~     In this study, the investigators are looking at how people make decisions about~     reward-related items, both monetary and food related after taking either the dopamine~     agonist bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects~     will fill self-report questionnaires and undergo an MRI scan.~   "
9763|NCT02929472|"~     The aim of this study was: to evaluate the effectiveness of a multicomponent pilot~     intervention in improving physical fitness (PF) and metabolic risk markers in children and~     adolescents; and examine if possible changes in PF are associated with metabolic risk~     markers in children and adolescents exposed to intervention. For such, a multicomponent~     pilot intervention was performed, consisting of sessions of physical exercise and nutrition~     education.The study included 35 children and adolescents (ages 7-13) divided into two~     groups: a intervention group (INT, n = 17) and a control one (CONT, n = 18). The sample~     underwent two moments of data collection (T0 and T1). The 1-hour exercise sessions were held~     based on an intensity above 65% of maximum HR. To assess the metabolic risk markers,~     analyzes of total cholesterol, HDL-C fraction, LDL-c fraction, triglycerides, blood glucose,~     insulin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were conducted~     in T0 and T1. Physical activity (PA) was assessed by accelerometry (Actigraph, GT3-X model,~     Florida) for 10 consecutive days. The health related PF components were evaluated throw~     different tests 20m Shuttle-run Test; handgrip dynamometry (TKK 5101 tightening D; Tokyo~     Japan); standing feet jump Test; Abdominal Test; trunk extension test; and body mass index~     (BMI) was calculated. Motor fitness was assessed by coordinations Test für Kinder - KTK. To~     assess food consumption, a 24-hour recall was held. For statistical analysis, the t-Student~     test and General Linear Model (GLM) - ANCOVA for repeated measures test with post-hoc~     Bonferroni (p <0.05) were performed. Multilinear regressions were done to analyse~     associations between measured outcomes.~   "
9764|NCT02929459|"~     The purpose of this trial is to investigate comprehensively the effect of riboflavin~     supplementation on the abundance of F. prausnitzii and on other members of the gut~     microbiota in faeces of healthy volunteers. Additionally it will be assessed whether~     riboflavin supplementation affects the abundance of potentially pathogenic bacteria such as~     adherent invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the~     production of Short Chain Fatty Acids, the release of gut hormones and potential changes in~     glucose homeostasis and appetite perception will be assessed.~   "
9765|NCT02929446|"~     Advances in surgical technique have led to a more complex surgery on patients with more~     serious comorbidities and the risk of postoperative pulmonary complications (PPC) such as~     pneumonia, and respiratory insufficiency, is considerable . The isolated effect of~     mobilization immediately after surgery has previously not been studied. The aim of the study~     is to evaluate the effects of immediate mobilization (within 2 hours) after abdominal~     surgery.~      Methods~      A randomized controlled trial will be conducted . A total of 200 Swedish-speaking, adult~     patients (≥18 years) planned for elective open abdominal surgery with surgery time exceeding~     2 hours are eligible for consecutive enrollment in the study. Patients who cannot walk~     independently will be excluded. Procedure: Patients will be randomized to either:~        1. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by~          1 hour bedrest during the day of surgery or to~        2. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by~          1 hour bedrest during the day of surgery + breathing exercises with PEP or to~        3. No mobilization - that is laying or sitting in bed with a maximum of 30° elevation of~          the head rest. No mobilization out of the bed until after 4 hours.~      Outcome assessment The primary outcome is occurrence of respiratory insufficiency defined as~     arterial oxygen pressure (PaO2) <8 kilo pascal (kPa) measured via arterial blood gas sample,~     or peripheral oxygen saturation (SpO2) <90%, measured peripherally with a pulse oximeter.~     Secondary outcomes are changes in arterial carbon dioxide pressure (PaO2), arterial oxygen~     pressure/fraction inspired oxygen (PaO2/FiO2) (arterial blood gas sample) over time and~     between groups; lung function assessed as inspiratory vital capacity (IVC), forced vital~     capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow~     (PEF) by a micro spirometer; number of patients with respiratory insufficiency, defined as~     SpO2 <90%, or PaO2 <8kPa and/or PaCO2 ≥6.5 kPa measured without oxygen supply ;~     postoperative pneumonia and total length of stay at the wards and at the hospital.~      Clinical significance If a fairly simple and cheap intervention, such as mobilization~     immediately after open abdominal surgery, can lead to less postoperative complications,~     shortened stay at hospital in total, it should be included as a routine in postoperative~     care.~   "
9766|NCT02929433|"~     The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support~     base, designed to measure the amount of muscle work performed during exercise and the~     resistance to pedaling. The cycloergometer has been already employed in many fields of~     medicine.~      However, up to date, a little use of cycloergometer in the management of chronic joint~     diseases has been documented and scientific studies have not clarified if cycloergometer is~     effective in these diseases and, particularly, in Rotator Cuff Tear patients.~   "
9767|NCT02929420|"~     The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in~     the treatment of cyclomastopathy.~   "
9768|NCT02929407|"~     The purpose of this trial is to investigate safety, tolerability, pharmacodynamics, and~     pharmacokinetics after intravenous administration of FE 204205 in patients with cirrhotic~     portal hypertension.~   "
9769|NCT02929394|"~     Maintenance therapy with trabectedin versus observation after first line treatment with~     doxorubicin of patients with advanced or metastatic soft tissue sarcoma.~      This is a prospective, multicenter, randomized, open label Phase III trial investigating~     whether a maintenance treatment with trabectedin, as compared to the observational approach,~     can prolong progression-free survival in patients with advanced, inoperable and/or~     metastatic STS after response or stabilisation during first line treatment with doxorubicin.~   "
9792|NCT02929095|"~     Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive~     disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so~     proper analgesia is important. ischemia-reperfusion injury is due to reactive oxygen~     species. Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the~     investigators research the patient's satisfaction that are given the dexmedetomidine during~     PTA procedure.~   "
9878|NCT02927951|"~     The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime~     pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce~     the level of pain associated with walking. Consequently, it is hypothesized that the~     reduction in pain will result in an increase in the amount of walking they do during the~     day, improvements in their gait, balance, risk of falls and sleep patterns.~   "
9770|NCT02929381|"~     The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical~     practice.~      The important elements of this evaluation are:~        -  Evaluation of the character of neoplastic lesions in the colon based on different~          imaging techniques~        -  Verification of the endoscopic image with histopathologic descriptions~        -  Establishing the type of the lesion on the basis of Kudo and NICE classifications~        -  Comparison of the result of histopathological examination with the macroscopic type of~          the lesion~        -  Determination of the most advanced lesions (MAL)~        -  Comparison of the cecal intubation time~        -  Evaluation of the type of anesthesia used during colonoscopy~        -  Subjective assessment of the severity of pain according to VAS (visual analogue scale)~        -  Comparison of the accuracy of the location of lesions on the basis of endoscopic~          navigation~        -  Comparison of the total examination time~        -  Comparison of adenoma detection rate~   "
9771|NCT02929368|"~     Peripherally inserted central catheters, or PICC lines, has now been successfully in use for~     many years, especially in the chemotherapeutic treatment of oncologic patients or in~     parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray~     (fluoroscopy). The aim of the clinical study is to assess the safety and the efficacy of the~     SHERLOCK-Systems eliminating the confirmatory chest x-ray exposure. Additionally, the~     SHERLOCK-System immediately confirms the PICC tip position even at the bedside of the~     patient, thus, saving costs and time.~   "
9772|NCT02929355|"~     Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with~     an increased risk of vascular events. Investigators assessed prospectively by arterial~     duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with~     diabetes to assess the importance of progression and to analyze the impact of this~     progression on vascular events. The main hypothesis is that people with carotid~     atherosclerosis progression are at higher risk of vascular events than those without any~     progression.~   "
9773|NCT02929342|"~     The purpose of this study is to better define the absorption and elimination pathways, and~     circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in~     healthy CYP2D6 genotyped male subject.~   "
9774|NCT02929329|"~     The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when~     added to standard of care is well tolerated and superior to placebo in reducing the risk of~     cardiovascular death or heart failure events in subjects with chronic HFrEF.~   "
9775|NCT02929316|"~     Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein~     found in wheat, barley, rye, malt) induces an immunological response in genetically~     susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the~     population worldwide. Long term sequelae are numerous and include risk of lymphoma,~     malabsorption leading to weight loss, anemia, multiple vitamin deficiencies,~     osteoporosis/osteopenia, secondary autoimmunity, etc. (1)~   "
9776|NCT02929303|"~     This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in~     infants and children with parenteral nutrition associated liver disease (PNALD) to decrease~     elevated liver enzymes and direct bilirubin.~      This study aims to describe the response of PNALD after use of Omegaven by normalization of~     serum levels of liver enzymes and bilirubin.~   "
9777|NCT02929290|"~     The main objective of this study is to evaluate the safety, tolerability, efficacy and~     pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.Biomarkers~     related to the efficacy of BPI-9016M will be investigated.~   "
9778|NCT02929277|"~     PASTURE is a birth cohort of children born to farm and non-farm women from rural areas~     across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled~     1133 children (farmers in about half of the children) to study the origins of asthma and~     atopy and to develop potential preventive strategies.~      Previous results show a protective effect of farm exposure on allergic risk by livestock~     contacts and microbial exposures and by raw cow milk consumption in early age.~      PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to~     characterize the allergic phenotype between 6 and 10 years old (asthma and allergic~     rhinitis) and to explain how early age exposures and particularly milk products consumption~     contribute in the process of allergic illness in childhood. A focus on the characterization~     of the protective biologically active components in raw milk and identification of~     immunological mechanisms are involved.~   "
9779|NCT02929264|"~     An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental~     hyperalgesia and its neural correlates.~   "
9780|NCT02929251|"~     RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to~     either anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm~     evidence or randomized controlled trials directly addressing the best biologic agent in~     severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal~     blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable~     remission over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in~     NIU has been dramatically reduced in the recent years with the use of biologics, raising the~     question of whether these compounds should be used earlier in the treatment of severe non~     infectious uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are~     highly effective in steroid's sparing thus preventing occurrence of cataract and/or~     glaucoma.~      Despite a strong rationale, these compounds are not yet approved in uveitis, which~     guarantees the innovative nature of this study that aims selecting or dropping any arm when~     evidence of efficacy already exists.~   "
9781|NCT02929238|"~     You are being asked to participate in this study because you have a complex wound that~     requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic~     technique which involves the placement of a wound vacuum at the site of the wound. The wound~     vacuum delivers a negative pressure at the wound site through a dressing. Any fluid~     collected during this process is collected through a foam (sponge) underneath the dressing.~     This therapy helps to draw the edges of the wound together, while removing infectious~     material, to help promote healthy tissue growth and speed up wound healing. The purpose of~     this study is to determine if placing polypropylene suture (a material normally used to~     close wounds) between the wound and the NPWT foam would decrease pain upon removal of the~     sponge while allowing adequate healing of the wound.~   "
9819|NCT02928731|"~     The aim of this study is to explore the impact of cancer and therapy-related symptoms on~     Mainland Chinese children's physical and psychological well-being.~   "
9782|NCT02929225|"~     Intestinal microbiota has recently emerged as an important player in the progression and~     complications of chronic kidney disease(CKD). And drug therapy which selects the gut as a~     target has raised lots of concern. It has been reported that the composition of intestinal~     flora has changed in uremic patients. Specifically, imbalanced ecosystem has higher number~     of pathogens such as Clostridia, Enterobacteria,and lower number of beneficial microbes such~     as Lactobacilli and Bifidobacteria. This modification of intestinal flora can strongly~     increase transformation of amino acids into Uremic Retention solutes, e.g., indoxyl-sulfate~     (IS), p-cresyl sulfate (PCS), which are so called gut-derived uremic toxins. The dysbiosis~     also contributes to an increase in intestinal permeability by disrupting the colonic~     epithelial tight junction,which may subsequently lead to translocation of endotoxin and~     bacteria into the host's internal environment,resulting in systemic micro-inflammation.Also~     all of these can promote the progression of renal failure and the incidence of~     cardiovascular complications,renal osteodystrophy and anemia.Probiotics is defined by the~     World Health Organization as 'live microorganisms that, when administered in adequate~     amounts, confer a health benefit on the host'. Probiotics are being increasingly used for~     various pathologic conditions.It is said that probiotics have a therapeutic role in~     maintaining a metabolically balanced gastrointestinal tract (GIT).And in our previous~     study,the investigators found that in uremic rats,lactobacillus acidophilus can relieve~     bacterial translocation and decrease the level of inflammatory markers.So our study is~     mainly designed to investigate whether probiotics can modulate the balance of intestinal~     ecosystem, prevent the bacterial translocation from gut and alleviate the systemic~     inflammation in hemodialysis(HD) patients.~   "
9783|NCT02929212|"~     The purpose of this study is to determine the effect of meal size and texture on the levels~     of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake~     change after bariatric surgery and patients often eat multiple small low-calorie meals, a~     pattern that may affect blood glucose as well as incretin levels. Whether the release of~     GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in~     'real life' setting of multiple small meals diet is unclear.~   "
9784|NCT02929199|"~     The aim of this study compare soft tissue reaction (bleeding, gingival color and texture),~     bacteria type and count in the gingival sulcus around the restoration margin and sulcus~     depth of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless~     its popularity in the dental field.~   "
9785|NCT02929186|"~     This is a randomized controlled pilot study aimed at testing different outreach strategies~     (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed~     home fecal immunohistochemical testing (FIT).~   "
9786|NCT02929173|"~     The aim of this study is to compare the patient satisfaction and clinical assessment (shade~     matching, surface texture and marginal discoloration) of Bio- High Performance Polymers~     (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.~      Regardless E-max popularity in the dental field.~   "
9787|NCT02929160|"~     Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with~     retrograde ureteric stenting for emergency renal decompression in cases of obstruction and~     sepsis associated with ureteric calculi.~   "
9788|NCT02929147|"~     An optimal analgesic therapy is very important for postoperative recovery. In recent years,~     several studies showed that the prevalence of the moderate to severe pain after craniotomy~     ranged from 69 to 87% of patients. In a previous study, the investigators showed that the~     use of morphine based patient controlled analgesia prevented moderate to severe~     postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side~     effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a~     general reluctance for their use in neurosurgery. Therefore, all patients were closely~     observed to detect opioid related side effects in the intensive care unit for 24 hours~     following surgery in the previous study. The Integrated Pulmonary Index (IPI) is a new tool~     that calculates respiratory and hemodynamic parameters noninvasively. In the present study~     the investigators will use different doses of morphine based PCA and the IPI system to~     determine more effective and safer morphine dose for postoperative analgesia following~     supratentorial craniotomy.~   "
9789|NCT02929134|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives~     doxycycline look-alike placebo tablets. However, both groups will be enrolled into a~     standardized regimen of hygiene described above. Thus, patients enrolled in the placebo~     group also will receive the current standard of care, and the placebo used in the study will~     help to identify the benefits of doxycycline on a background of simple hygiene measures. The~     regimens will be explained to all participants who will be trained to use established~     standardized methods of hygiene and be effectively applying it prior to the initiation of~     the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A~     common, generic SOP with handouts that describes methods and the training schedule will be~     used so that similar methods are employed across all sites.~   "
9790|NCT02929121|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives~     doxycycline look-alike placebo tablets. However, both groups will be enrolled into a~     standardized regimen of hygiene described above. Thus, patients enrolled in the placebo~     group also will receive the current standard of care, and the placebo used in the study will~     help to identify the benefits of doxycycline on a background of simple hygiene measures. The~     regimens will be explained to all participants who will be trained to use established~     standardized methods of hygiene and be effectively applying it prior to the initiation of~     the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A~     common, generic SOP with handouts that describes methods and the training schedule will be~     used so that similar methods are employed across all sites.~   "
9793|NCT02929082|"~     FORCE project aims to measure actives forces of malignant tumor by magnetic resonance force~     (FRM). Two main forces are considered as key indicators of therapeutic response and~     metastatic potential: interstitial force and traction force at the interface cell/tumor.~     Biomarkers of these forces will be developped using direct images of magnetic resonance~     force (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their~     capacity to predict tumoral environment invasion, notably micro-vascular invasion, and~     therapeutical results in Hepatocellular Cancer (HCC).~      Principal criteria will be~        1. micro-vascular invasion assessed by pathological examination of surgical pieces (gold~          standard).~        2. interstitial force and traction force at the cell/tumor interface assessed by FRM.~      Population of patients will be divided in three groups. A first group will be constituted of~     20 volunteer patients coming for abdominal MRI with no known hepatic disease, in order to~     determine the feasibility of FRM. A second group will be constituted of 60 patients with~     resectable HCC eligible for surgery. This group will enable to evaluate the tumoral~     environment invasion. Third group will be constituted of 50 patients with HCC eligible for~     transplant with transcatheter arterial chemoembolization (TACE) treatment as pending~     treatment before transplant. This groups will enable to evaluate the efficiency of TACE~     through the necrosis percentage in treated HCC.~      Inclusion of patients will occur during 24 months for a total study duration of 36 months.~      All patients will have MRI as usual care. FRM is performed during MRI with the use of a~     specific medical device and therefore corresponds to an additional procedure of the~     research.~      Moreover, patients in group 2 and 3 will be asked to participate to an ancillary study~     consisting in circulating tumoral cells (CTC) measurement. If they accept, a blood sample~     will be collected just before the MRI in order to evaluate the correlation between CTC and~     micro-vascular invasion.~   "
9794|NCT02929069|"~     The intent of the proposed randomized controlled trial is to test the efficacy of a~     principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that~     addresses the pathways through which minority stress compromises young gay and bisexual~     men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and~     sexual (e.g., condomless anal sex) health problems.~   "
9795|NCT02929056|"~     The purpose of this study is to evaluate and compare healing characteristics, reduction in~     the size of the wound and to measure complete healing of the wound following the application~     of a biologic product dressing instead of the alginate dressing along with standard~     debridement and compression therapy versus the standard of care treatment for VLUs. The~     biologic product that will be used in this study is called AmnioExCel™.~   "
9796|NCT02929043|"~     Up to date, devices capable of delivering controlled, calibrated, non-contact cold air~     stimuli in a MR environment are unavailable for quantitative sensory testing. This project~     therefore aimed at designing and constructing a novel MR-compatible, computer-controlled~     cold air stimulation device that produces air puffs in a broad flow and cold temperature~     range. By means of this device, detailed psychophysically testing and subsequent brain~     scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights~     about DH mechanisms.~   "
9797|NCT02929030|"~     The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting~     coronary stent system (NANO plus) in patients with coronary artery disease . The primary~     endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel~     related myocardial infarction and clinically-driven target lesion revascularization at 1~     year follow-up.~   "
9798|NCT02929017|"~     Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to~     receive this intervention or usual care. The intervention will include information about the~     disease, self-management strategies, and introduction to advanced care planning in a format~     with enhanced content available across multiple domains (face-to-face, printed material,~     digital (tablet) delivered by an interventionist. The usual care group will be provided with~     routine printed patient education.~      At the end of life, IPF patients and their caregivers experience stress, symptom burden,~     poor quality of life, and inadequate preparedness for end-of-life care planning. The~     proposed study will measure feasibility, acceptability, and impact of a Supportive Care~     intervention.~   "
9799|NCT02929004|"~     These last years, it has been proven that the solicitation of a muscle using vibration may~     lead to positive effects on the neuromuscular function. Thus, the aim of the current study~     is to assess if the addition of local vibration training sessions on the quadriceps muscle~     to the classic readaptation program (i.e. physiotherapist sessions) may allow a better~     recuperation 2 months after the surgery and the reconstruction of the anterior cruciate~     ligament.~      The aim of the vibration training proposed in the current study is to allow a better~     recuperation 2 months after the anterior cruciate ligament reconstruction when compared with~     conventional physiotherapy alone.~   "
9800|NCT02928991|"~     This is a pilot study to determine whether fludarabine-based reduced intensity conditioning~     (RIC) regimens facilitate successful donor engraftment of patients with acquired aplastic~     anemia (AA) and Inherited bone marrow failure (iBMF) syndromes undergoing Matched related~     donor bone marrow transplant (MRD-BMT).~   "
9801|NCT02928978|"~     This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the~     study participants will receive ruxolitinib for approximately 15 days, and the other half~     will receive a placebo (sugar pill) for approximately 15 days. Once study participants have~     completed their ruxolitinib or placebo, participants will undergo surgery to remove the~     premalignant breast tissue.~   "
9802|NCT02928965|"~     The purpose of this study is to investigate if minocycline limits the development of~     negative symptoms in early psychosis and to test via what mechanism of action this change~     occurs.~   "
9803|NCT02928952|"~     The purpose of this study is to see if adding Mindfulness training to diabetes education~     reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve~     diabetes outcomes (such as hemoglobin A1c).~   "
9804|NCT02928939|"~     Clinical practice guidelines do not take into account multimorbidity and various potential~     therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in~     multimorbid patients having more than two acute or chronic diseases. Guidance should be~     available for frequent encountered situations, e.g. gastrointestinal bleeding or~     exacerbation of diabetes mellitus.~   "
9828|NCT02928614|"~     This is a substudy to a randomized trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counseling, after which they will be randomized to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of biomarkers in~     obese patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or~     Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
9805|NCT02928926|"~     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally~     maintained at a constant level, over a relatively wide blood pressure range. It can be~     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using~     ultrasound probes over both sides of the head to measure changes in blood flow in one of the~     main brain arteries (the middle cerebral artery) in response to beat to beat changes in~     blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired~     following moderate to severe stroke, acting as a key role in the development of secondary~     brain damage related to brain swelling and further damage related to low blood flow. The~     administration of clotbusting therapy (thrombolysis), one of the main approved treatments of~     acute ischaemic stroke (AIS), results in recanalization of the blocked artery in over~     approximately 50% patients. However, due to its clot dissolving property, it may increase~     the risk of bleeding in the body, especially in the brain, leading to greater disability or~     even death. To date, there has been very little information regarding the natural history~     and prognostic significance of impaired Cerebral Autoregulation during and following~     reperfusion, especially those who receive thrombolysis. This research will use the~     noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in AIS~     patient at the initiation and completion of thrombolysis, and during acute, subacute and~     chronic phase post stroke onset, compared with those AIS patient who did not receive~     thrombolysis. This study will provide important data regarding perithrombolysis blood~     pressure management, an important and common clinical dilemma~   "
9806|NCT02928913|"~     To investigate associations between sedentary and active behaviour with bone health and~     functional ability, and to associate mechanical loading at the lumbar spine and hip in~     sedentary and active individuals with bone mineral density.~   "
9807|NCT02928900|"~     The goal of this study is to develop and evaluate a clinical training intervention utilizing~     standardized patient actors to improve communication and interpersonal skills of health care~     workers who serve HIV-infected adolescents and youth in Kenya, resulting in increased~     engagement in HIV care. The effect of the intervention on retention in care will be~     evaluated in a stepped-wedge randomized controlled trial at 24 HIV care and treatment~     facilities.~   "
9808|NCT02928887|"~     The goal of this study is to determine whether or not exposure to blue spectrum light~     reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary~     bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to~     either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light~     for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the~     immediate postoperative period.~   "
9809|NCT02928874|"~     Using an integrated approach, this study examines multiple eating traits concurrently under~     states of hunger and satiety. It examines the impact of short-term appetite and intake~     regulation on longer-term energy intake control and weight development in a cohort of~     ethnically diverse normal-weight and obese boys and girls with different familial~     predispositions to obesity.~   "
9810|NCT02928861|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     diffuse large B-cell lymphoma can predict disease progression~   "
9811|NCT02928848|"~     In the present sham-controlled study, the investigators examine whether tDCS could be used~     to enhance language abilities (e.g., picture naming) in individuals with PPA variants~     primarily characterized by difficulties with speech production (non-fluent and logopenic).~   "
9812|NCT02928835|"~     To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a~     total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were~     randomly assigned in two groups: control group and Dynasplint group.~   "
9813|NCT02928822|"~     The purpose of this study is to determine whether VR based language rehabilitation scenario~     based on the core premises of ILAT has a beneficial effect on the linguistic performance~     (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients.~     Furthermore, it aims at testing the effects of cueing (visual and auditory) on word~     retrieval.~   "
9814|NCT02928809|"~     The objective of this study is to perform an evaluation of the effect of LLLT on the~     prevention of fatigue in the masseter and anterior temporal muscles in young individuals~     with and without TMD.~   "
9815|NCT02928796|"~     Uncovering the distinct measurements and features that potentially exist in different levels~     of expertise when performing cardiology-based procedures. There is a belief that tracking~     the visual attention and other psychophysiological measures during performance of these~     procedures may assist in uncovering the attentional capacity of participants and how it~     links with overall performance.~   "
9816|NCT02928783|"~     Home-based rehabilitation programs have not been widely few been studied and the training~     effects are not unclear. This study evaluates the beneﬁcial effects of home-based cardiac~     rehabilitation on quality of medical care in patients with chronic heart failure.~   "
9817|NCT02928757|"~     There are ~6,200 children in Ontario with special and complex healthcare needs requiring~     multiple services from many different doctors and other healthcare providers. These children~     are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial~     burden and stress on families. While small in number (<1% of Ontario kids), these children~     use 1/3 of all child healthcare resources, and are known to desperately need coordinated~     care to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers,~     children and families, and healthcare providers from across Ontario to develop, implement~     and evaluate an evidence-based and coordinated model of care for every child with medical~     complexity in Ontario.~   "
9818|NCT02928744|"~     Limitation of expiratory flows is considered as the main determiner of dynamic distension~     and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and~     distal resistances should allow to better appreciate the functional impact.~      This study should also allow to specify the best parameters in respiratory functional~     explorations useful for the follow-up in COPD and to specify the relevance of functional~     indications other than the forced expiration volume at 1 second (FEV1) or the functional~     residual capacity (FRC) to estimate in a more relevant way the clinical improve with the~     increase of the therapeutic load (increase of posology, association of two~     bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled~     patients suffering from a persistent dyspnoea insufficiently relieved.~   "
9820|NCT02928718|"~     Pancreatitis remains the most common complication of ERCP, with the reported incidence~     ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may~     develop severe pancreatitis, that means additional morbidity and risk for death. ERCP,~     despite the development of new diagnostic tools, remains a widely used procedure, so~     post-ERCP pancreatitis is a problem with significant impact. Several studies and~     meta-analyses helped us to recognize special factors that put an individual in high risk for~     the development of post-ERCP pancreatitis. Among these factors special interest presents the~     history of post-ERCP pancreatitis as an independent risk factor for a new episode of~     post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed~     susceptibility in this particular complication. The aim of the present study is to~     investigate the possible genetic variation associated with post-ERCP pancreatitis using~     whole genome sequencing.~   "
9821|NCT02928705|"~     The purpose of this retrospective study is to analyze quality and adverse events of~     analgesia by telemedically supported paramedics in comparison to conventional treatment by~     on-scene emergency medical service (EMS) physicians in the EMS of the city of Aachen,~     Germany.~   "
9822|NCT02928692|"~     Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged~     patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of~     POCD is not clear yet and no effective therapy method was proved. According to previous~     study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a~     tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood~     brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven~     in many experimental animal models such as Alzheimer's disease, Huntington's disease and~     Parkinson's syndrome. In present study, the investigators hypothesized that minocycline~     would attenuate the incidence of POCD and POD in the aged patients.~   "
9823|NCT02928679|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counseling, after which patients will be randomised to~     receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic~     guidance on re-introducing regular foods and a focus on continued motivation to engage in a~     healthy lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of, joint~     inflammation, articular cartilage composition, overall knee morphology, and clinical~     symptoms, in obese patients with knee osteoarthritis following a randomisation to~     Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
9824|NCT02928666|"~     Introduction: in the course of the research, the investigators will develop a~     decision-support system (comorbidity-DSS) consisting (1) a knowledge base (KB) consisting of~     (a) computer-interpretable clinical guidelines for type 2 diabetes and 2 other diseases~     from: obstructive pulmonary disease, osteoporosis, hypertension, and osteoarthritis; and (b)~     an ontology of relevant general medical knowledge that could complement (a) in order to~     propose non conflicting treatment options not mentioned in the clinical practice guidelines;~     and (2) an algorithm that matches the KB with a patient's data set to identify the~     guidelines-based recommendations applicable for the patient and their interactions and which~     proposes ways to mitigate conflicting interactions (e.g., suggesting to select intervention~     A.2 (instead of A.1) from guideline A and intervention B.3 (instead of B.1) from guideline B~     together with an action B' mentioned in the general medical knowledge, because these~     interventions are not conflicting yet A.3 fulfills the same goals as intervention A.1 and~     intervention B.3 + B' together fulfill the same goal as B.1).~      Research purpose: Assessing the correctness and completeness of detection of~     recommendation-interaction and generation of conflict-free recommendations by a~     comorbidity-DSS~      Research question: How will the usage of the comorbidity-DSS affect the completeness and~     correctness of clinicians regarding (a) detection of interactions between recommendations~     originating from different clinical guidelines applicable for patients with comorbidities~     and (b) identification of interventions that fulfill the guidelines' goals and are not~     conflicting.~   "
9825|NCT02928653|"~     The aim of this study will be to compare the effects of daily consumption of aspartame,~     rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a~     standardized protocol. The investigators hypothesize that individual low calorie sweeteners~     (consumed in a beverage) differ from each other in promoting weight loss and decreased fat~     mass (without energy restriction or dietary guidance) based on their chemical structure.~   "
9826|NCT02928640|"~     The purpose of the study is to collect information on prostrate biopsy tissue for use in~     developing a method determining the difference in normal and cancerous prostrate tissue~     using the ClariCore System.~   "
9827|NCT02928627|"~     Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the~     third cause of cancer-related mortality worldwide. Depending on the stage of the disease,~     the treatment options are surgery, liver transplantation, chemotherapy or radiotherapy.~      Recently, scientific research has focused on small molecules called microRNAs which are~     produced by human cells and can be released in the blood. They have a role in cell~     proliferation and are found to be dysregulated in different types of cancer.~      It has been shown that microRNAs have a role in the development of HCC but it is unknown if~     these molecules can be used as markers for diagnosis and survival in HCC.~      In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in~     about 80% of patients with HCC. This can be assessed on tissues from liver biopsies or~     surgical specimens, both invasive approaches. Only few studies showed the presence of~     microRNAs in the blood of patients with HCC but it is unknown if there is a correlation~     between tumoral tissue expression and circulating levels.~      The aim of this study is to evaluate if these two microRNAs are expressed not only in the~     tumoral tissues but also in the blood from cancer patients, and in different amounts~     compared to circulating levels in healthy individuals. A correlation between tumoral tissue~     and blood levels will also be evaluated.~      Should this evaluation show a strong correlation and reliability of circulating microRNAs in~     the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and~     their related pathways might benefit from this being adopted as conventional practice~     instead of the need of assessing tissue levels from liver biopsies.~      The results of this pilot study will bring preliminary results as a first step for future~     analysis on a larger cohort of patients.~   "
9829|NCT02928601|"~     This study evaluates the effect of prophylactic ondansetron on the incidence of spinal~     hypotension and vasopressor consumption in caesarean section patients using norepinephrine~     treatment. Half of participants receive ondansetron before spinal anesthesia while the other~     half receive saline.~   "
9830|NCT02928575|"~     The purpose of this study is to determine whether a combination of Sunitinib, Temozolomide~     and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma~     patients harboring tumors with unmethylated MGMT promoter.~   "
9831|NCT02928562|"~     Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative~     pain and swelling, protection of the healing graft, restoration of full range of motion~     symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee,~     hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional~     activities that are required for return to the normal daily life. The effects of concomitant~     injuries and surgical procedures must also be considered in planning an individualized~     rehabilitation program. However, it is still unclear regarding the optimal exercise~     prescription after TKA. In the current study, the investigators plan to develop an exercise~     protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density~     assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and~     resistant training exercise for first, second and third year, respectively. Cyclic exercise~     is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the~     exercise can be quantitatively determined. Aerobic exercise is privileged by the~     cardiopulmonary endurance improvement, along with muscle strengthening in the associated~     muscle groups. Resistance exercise is specified for the indicated muscle groups, especially~     knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed~     patients. The investigators hypothesis that using this cyclic exercise process can improve~     the body composition, muscle strength, bone mass density, level of oxidative damage~     indicators, gait performance, quality of life, knee joint range of motion, function of~     cardiopulmonary and fitness. This project will establish the scientific basis for~     rehabilitation protocol involving knee surgery.~   "
9832|NCT02928549|"~     The purpose of this study is to explore the experiences of Black women who receive care for~     ovarian cancer at Memorial Sloan Kettering Cancer Center, or MSK for short. The study~     consists of interviews with Black women who recently obtained some part of their ovarian~     cancer care at MSK.~   "
9833|NCT02928536|"~     Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a~     European cross-sectional study, aiming at i) estimating prevalence and investigating~     determinants of smoking, e-cigarette use and exposure to SHS and to e-cigarette aerosol; ii)~     analyzing the attitudes, perceptions and behaviours of the adult European population towards~     policies to limit SHS exposure; iii) comparing selected smoking-related data between TackSHS~     and a previously conducted pan-European survey; iv) assessing mortality and morbidity from~     selected respiratory and cardiovascular diseases attributable to SHS exposure among adults~     and children in Europe; v) quantifying the economic burden associated to the exposure to SHS~     and e-cigarette aerosol in Europe. Overall, approximately 12,000 individuals aged 15 years~     or over will be enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV,~     PL, PT, RO, UK). Surveys will be representative of the country-specific population in terms~     of sex, age, and socio-economic characteristics.~   "
9834|NCT02928523|"~     The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute~     myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order~     to restore the balance of their intestinal microbiome and thereby eradicate~     treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as~     well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to~     perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in~     AML patients receiving intensive chemotherapy, and who are usually heavily treated with~     broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For~     this purpose, at the time of admission and AML diagnosis, patients will be requested to~     donate stools that will be comprehensively screened, and if deemed appropriate according to~     protocol criteria, conditioned and stored frozen until future processing and transplantation~     after aplasia completion.~   "
9835|NCT02928510|"~     This research trial studies the mechanisms of idelalisib-associated diarrhea in patients~     with chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, or small lymphocytic~     lymphoma that has come back after a period of improvement. The cancer treatment drug~     idelalisib triggers diarrhea in some patients. Studying stool, blood, and tissue samples in~     the lab from patients who are given idelalisib may help doctors learn more about the side~     effects and may help to treat them in future patients.~   "
9836|NCT02928497|"~     The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left~     Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for~     subjects with non-valvular atrial fibrillation who are deemed not to be eligible for~     anti-coagulation therapy to reduce the risk of stroke.~   "
9837|NCT02928484|"~     The purpose of this pilot study is to evaluate whether a probiotic supplement improves~     gastrointestinal (GI) function.~   "
9838|NCT02928471|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counseling, after which. Patients will be randomised to~     receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic~     guidance on re-introducing regular foods and a focus on continued motivation to engage in a~     healthy lifestyle.~      This substudy aims to investigate any changes in MRI associated with the initial 8-week~     weight loss intervention, and the value of CT scans in predicting the effect of weight loss.~   "
9839|NCT02928458|"~     This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a~     condition in which the small intestine gets blocked due to scars called adhesions. To see~     the blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD~     Gastroview and omnipaque are two contrast agents that may be given as part of your normal~     care for ASBO. This study hopes to see if one is better than the other.~   "
9840|NCT02928445|"~     This 6-month extension study will provide further information regarding the long-term safety~     and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB)~     who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.~   "
9841|NCT02928432|"~     Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered~     with prednisone to decrease the adverse event related to CYP171A suppression.~      Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that~     progress biochemically to AA + prednisone can improve the number and the length of the~     responses, and also improve tolerance to treatment, decreasing the adverse events associated~     to a moderate dosage of steroids used chronically.~   "
9842|NCT02928419|"~     Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by~     inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the~     main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia~     and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The~     only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in~     the presence of bleeding.~      In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic~     abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these~     latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has~     been approved by FDA and EMA. It has been shown that the drug induces significant erythroid~     (about 65%) and cytogenetic responses which have been associated with a survival benefit. In~     patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide~     dosing of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of~     transfusion-independence and cytogenetic responses with a trend to survival advantage. As a~     consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on~     days 1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the~     Absolute Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.~      For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L~     (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥~     25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at~     any time, to resume lenalidomide at 50% dose reduction.~      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been~     shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither~     increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts.~     Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in~     the formation of normal megakaryocytic colonies. These results provide the rationale for~     pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of~     MDS.~      Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of~     efficacy, safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS~     has shown that eltrombopag is able to significantly raise PLT counts in about 65% of~     patients without additional toxicity Furthermore, the combination of lenalidomide and~     eltrombopag resulted in significant inhibitory effects on the growth of leukemic colonies in~     the majority of primary MDS and AML samples. Most importantly, eltrombopag was able to~     reverse the anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples.~     These results provide a preclinical rationale for the use of this combination in MDS and AML~   "
9843|NCT02928406|"~     This multicenter study will assess the safety of atezolizumab as second-line treatment for~     participants with locally advanced or metastatic urothelial or non-urothelial cancer of the~     urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor~     biomarkers associated with atezolizumab.~   "
9844|NCT02928393|"~     This Phase 2a, randomized, double-blind, placebo-controlled, parallel group study will~     evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with~     severe motor impairment following an ischemic stroke.~   "
9845|NCT02928380|"~     In this clinical study, an experimental denture adhesive with a precision tip nozzle will be~     tested to evaluate the relative efficacy to reduce the ingress of food under the denture~     compared to use of no adhesive or a standard marketed adhesive.~   "
9846|NCT02928367|"~     Community-acquired pneumonia (CAP) represents a major health care problem and mortality and~     morbidity associated with severe pneumonia remain considerable, despite state of the art~     care.~      While the role of altered DNA methylation in cancer has been widely studied, knowledge of~     its impact on antibacterial defense is highly limited. In addition, recent preclinical~     studies showed that the gut and respiratory microbiota contributes to host defense against~     bacterial pneumonia.~      This study aims to explore a completely novel research area linking the extent of DNA~     methylation in blood leukocyte (monocytes and neutrophils) and function of gut and~     respiratory microbiota on the influence of innate immune responses to and host defense~     against CAP~   "
9847|NCT02928354|"~     This study is an open label, randomized, three-way crossover study to assess the effect of~     particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects~     (males aged 18 to 55 years [inclusive]). The study will be performed at a single study~     center.~   "
9848|NCT02928341|"~     The aim of the study is to evaluate the impact of a large-scale urban water supply~     improvement intervention on cholera and other diarrhoeal diseases. The study uses a step~     wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention~     on cholera centre admission rates and confirmed cholera cases. A nested cohort study will~     examine changes in water-related practices following the intervention.~   "
9849|NCT02928328|"~     The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human~     subjects has never been investigated. However, as earlier studies suggest that activation of~     peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if~     these findings can be translated into human subjects to determine if peripheral GABAA~     receptors are a viable target for future analgesic drug development.~   "
9850|NCT02928315|"~     It is well known that magnesium sulfate has a membrane stabilizing effect , and broad~     spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic~     effect against atrial fibrillation in postoperative period of cardiac surgery.~   "
9851|NCT02928302|"~     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about~     15 million babies are born too soon every year, causing 1.1 million deaths, as well as~     short- and long-term disability in countless survivors. Few prognostic tests are available~     to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to~     be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The~     evidence supports the use of vaginal progesterone in singleton pregnancies with short~     cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton~     gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without~     prior PTB, nor in multiple gestations.~      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low~     risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL~     screening in singleton pregnancy without prior spontaneous PTB~   "
9852|NCT02928289|"~     The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences~     VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic~     subjects with open-angle glaucoma.~   "
9853|NCT02928276|"~     RA is the most common inflammatory, persistent and progressive disease of the joints with~     serious co-morbidities and huge health and socio-economic impact worldwide.~   "
9854|NCT02928263|"~     A retrospective study to evaluate healthcare cost and resource utilization for patients with~     metastatic renal cell carcinoma who have been treated with IV or oral agents~   "
9892|NCT02927769|"~     The purpose of this study is to determine whether nivolumab + brentuximab vedotin, followed~     by brentuximab vedotin + bendamustine for participants with a suboptimal response, is safe~     and effective in the treatment of classic Hodgkin lymphoma (cHL) in children, adolescents,~     and young adults after failure of first line therapy.~   "
9893|NCT02927756|"~     Study purpose is to evaluate treatment outcome and survival in patient with aggressive~     lymphomas transformed from Follicular Lymphoma.~   "
9855|NCT02928250|"~     Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by~     Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and~     innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical~     mediated damage to cellular macromolecules either by chelating divalent cations or~     scavenging hydroxy radicals with its imidazole moiety. Free-radical damage is not the only~     process to affect the structure of proteins and nucleic acids.~      To the best of our knowledge, no previous study assessed the role of carnosine in diabetes~     associated complications in particular diabetic nephropathy and there is insufficient~     evidence to recommend its supplementation in those patients. Therefore, this study was~     undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic~     nephropathy in children and adolescents with type 1 diabetes and assess its relation to~     microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.~   "
9856|NCT02928237|"~     To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the~     motor cortex to reduce chronic abdominal visceral pain in a group of participants with~     hepatocellular carcinoma~   "
9857|NCT02928224|"~     This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib +~     cetuximab plus or minus binimetinib versus Investigator's choice of either~     irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC~     whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The~     study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib +~     binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.~   "
9858|NCT02928211|"~     Single center, open-label study for which each cohort is defined according to the number of~     administrations of the medical imaging agent, Aftobetin-HCl received. The medical imaging~     agent (the ointment) is applied to the cornea and time to detection of optimal fluorescence~     (amyloid burden) in the lens of the eye is determined. This will be measured by the Sapphire~     II device in subjects who are cognitively normal, or have mild cognitive impairment or mild~     Alzheimer's Disease.~   "
9859|NCT02928198|"~     The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the~     efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold~     provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive~     subjects with and without fenestration towards the side branch.~      Patients included in this study will be divided into three different cohorts:~        -  Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.~        -  Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.~        -  Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.~      All patients will also have telephone FU at 30 days, 12, 24 and 36 months.~   "
9860|NCT02928185|"~     The purpose of this study is to see what the patients perceptions are of the Coping Together~     manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation~     (HSCT), and if they would make any changes to Coping Together manuals for future patients,~     caregivers and couples that use these manuals after their HSCT. The investigators would also~     like to see what is the caregiver's perception of this intervention, and to see if they have~     any suggestions for changes. If the caregiver is interested in providing feedback, they will~     sign a separate consent form.~   "
9861|NCT02928172|"~     Hypothesis:~      There is a statistically measurable correlation between qNOX and rough clinical signs of~     insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA)~     insertion, skin Incision, LMA removal. It will reduce the problem of anticipating the~     nociception in patients undergoing general anesthesia.~      Objectives:~        1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the~          Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery~          under sedation and general anesthesia.~        2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and~          the qCON index of hypnosis.~        3. to assess qNOX reliability as a specific indicator of response to nociceptive~          stimulation.~   "
9862|NCT02928159|"~     This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy~     (LAP-ST) (primary outcome).~   "
9863|NCT02928146|"~     The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia~     repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open~     hernia repair.~   "
9864|NCT02928133|"~     Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias~     need to be anticoagulated. It is not known whether non-vitamin K antagonist oral~     anticoagulants (NOAC) in this patient group are efficient and safe.~      Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for~     thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart~     disease (CHD).~      Methods: In this multicenter prospective registry adult CHD patients with atrial~     tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a~     minimum of two years.~      Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic~     stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of~     stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according~     to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event~     analysed separately, all-cause mortality, therapy adherence, quality of life, risk~     assessment of stroke and evaluation of natural history of atrial tachyarrhythmia in adult~     CHD patients.~      Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated~     as Kaplan Meyer estimates of event free survival and event rates per year.~   "
9877|NCT02927964|"~     This phase Ib/II trial studies the side effects and best dose of toll-like receptor 9 (TLR9)~     agonist SD-101 when given together with ibrutinib and radiation therapy and to see how well~     they work in treating patients with grade 1-3a follicular lymphoma that has come back after~     a period of improvement or no longer responds to treatment. Immunostimulants such as TLR9~     agonist SD-101 may increase the ability of the immune system to fight infection and disease.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Giving TLR9 agonist SD-101 with ibrutinib and radiation therapy may induce an immune~     response and prolong anti-tumor response.~   "
33512|NCT02618421|"~     The purpose of the study is to determine prevalence of lower urinary tract symptoms in~     population aged 40 years or over, in China, Taiwan and South Korea using latest ICS~     definition.~   "
9865|NCT02928120|"~     Colorectal cancer (CRC) is one of the most common forms of cancer and the second leading~     cause of cancer-related deaths in the western world.~      CRC mortality is related to stage of disease with a five year survival for early-stage~     disease of 77.0% and 50.8% for late stage disease. Methods for early detection of primary as~     well as recurrent CRC are therefore important to increase patient survival. Tumour~     biomarkers from blood, stool, or urine could aid the early diagnostics of CRC, but despite~     extensive research such markers have only provided limited clinical value.~      Sporadic CRC develops as a result of the accumulation of genetic and epigenetic alterations.~     Epigenetic alterations include DNA hypermethylation, which through transcriptional silencing~     of tumour suppressor genes is associated with cancer development and cancer progression. The~     search for gene promoter regions hypermethylated in cancer has been ongoing for nearly two~     decades, and a number of genes have been shown to be preferentially hypermethylated in CRC.~     Therefore, hypermethylated DNA in plasma has been suggested as a marker for tumour-stage and~     survival in CRC patients. The only approved biomarker for the detection of CRC recurrence is~     the protein carcinoembryonic antigen (CEA). CEA is limited by its low sensitivity and~     therefore not recommended as a diagnostic biomarker. Hypermethylation of CRC specific genes~     as part of a molecular biomarker panel measured in blood could prove to be a recurrence~     marker in CRC patients, with elevated sensitivity and specificity.~      The aims of this project are to examine if hypermethylation of specific genes measured from~     cell-free DNA in plasma of CRC patients can be used to detect primary CRC, to detect CRC~     recurrence and to be a biomarker for CRC prognosis.~      Development of a reliable sensitive and specific biomarker for CRC will immensely improve~     the diagnostics and handling of CRC patients.~   "
9866|NCT02928107|"~     The aim of this project is to develop evidence that can inform hearing health care best~     practices for adults between the ages of 65-75, and to determine what level of involvement~     by the primary care practitioner (PCP) is required to inform and encourage adults age 65-75~     to follow through with routine hearing screening. The ultimate goal is to provide~     information to implement changes in health care policy to facilitate accessible and~     affordable hearing health care.~      This project will compare implementation of three PCP-based hearing screening strategies~     that include progressive levels of PCP time and guidance to complete telephone-based hearing~     screening.Those who fail screening go on to a medical referral study and receive (1)~     diagnostic audiological testing and (2) determination of the reliability and validity of~     identification of conditions that should require medical referral prior to hearing aid~     provision (called FDA 'Red Flag' conditions, including conditions such as sudden hearing~     loss, cerumen impaction, conductive hearing loss, dizziness, external deformity, ear~     drainage). Adults between the ages of 65-75 years old who are being seen for a routine~     appointment at a participating Duke primary care site may be eligible to participate.~      The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial~     the phone number and complete the test at or within two months of their PCP visit, relative~     to Group 3.~      Secondary outcome measures will be the proportion of subjects in all groups who: a) schedule~     and b) complete the visit for diagnostic audiological testing, and subsequently, c) complete~     a plan for appropriate hearing loss intervention, if indicated, within four months of~     initial hearing screening. Physical exams and procedures associated with this study present~     no significant risk to the participant.These are conducted routinely in the clinical~     setting.There is the potential for loss of confidentiality.~   "
9867|NCT02928094|"~     The purpose of this study is to determine whether a single intracoronary infusion of an~     adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4~     (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional~     class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life.~     Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The~     primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT)~     duration. Long-term safety of Ad5FGF-4 will also be assessed.~   "
9868|NCT02928081|"~     The aim of this study is to determine whether the performance of extended lymphadenectomy in~     association with pancreatoduodenectomy improves the long-term survival in patients with~     pancreatic head ductal adenocarcinoma.Half of participants will receive~     pancreatoduodenectomy with extended lymphadenectomy,while the other half will receive~     pancreatoduodenectomy with standard lymphadenectomy.~   "
9869|NCT02928068|"~     The purpose of this study is to investigate the efficacy of a 12 week telehealth~     intervention for families of children with autism spectrum disorders under the age of 6~     years on child participation and parent efficacy.~   "
9870|NCT02928055|"~     The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain~     (HSP) reduction due to treatment with peripheral nerve stimulation. We will explore the~     association of subject-specific clinical and demographic information and pain relief from~     PNS. We will explore the possible role of central sensitization mechanisms in perpetuating~     pain via measures of sensory and pain perception. Lastly, we will explore the dose-response~     association of muscle-contraction from PNS and pain reduction, completion of activities of~     daily living (ADLs), and improvement in quality of life.~   "
9871|NCT02928042|"~     This study evaluates that P. aeruginosa, A. baumannii, Staphy. aureus and K. pneumonia which~     are obtained from patients' tracheal aspiration culture who treated with mechanical~     ventilation will be compared with Lactobacillus (LAB) members in the laboratory. The aim is~     to investigate the probiotics' antimicrobial properties and effects on these bacteria's~     growth rate.~   "
9872|NCT02928029|"~     This study will be conducted in 2 parts. The phase 1b part will be an international, phase~     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with~     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary~     endpoint is to determine the optimal dose of radium-223 dichloride in combination with~     bortezomib/dexamethasone for the Phase 2 portion of the study.~      The phase 2 part will be an international, phase 2, double-blind, randomized,~     placebo-controlled assessment of radium-223 dichloride versus placebo administered with~     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma.~      Up to approximately 30 total subjects in all dose cohorts combined will be treated in the~     phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2~     part of the study.~   "
9873|NCT02928016|"~     In a randomized, cross-over designed study, the investigators examined the effectiveness of~     the carbohydrate counting method after consumption of mixed meals typical of the Greek~     cuisine with various protein and fat contents in a sample of people with type 1 diabetes~     (DM1). The investigators also tried to further explore the effects of additional extra~     virgin olive oil (11 ml) on the glycemic response.~   "
9874|NCT02928003|"~     Chronic post-thoracotomy pain is the most common long-term complication that occurs after a~     thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other~     factors (genetic, psychological) could have a major and independent role in the development~     of the post operative pain.The main objective of this study is to identify genetic and~     psychological profile (cognitive and emotional) of patients who develop chronic pain after~     lung surgery.~   "
9875|NCT02927990|"~     The new software package is intended to assist the physician in imaging the coronaries~     during percutaneous coronary interventions.~      This study investigates the amount of contrast used during percutaneous coronary~     interventions with the aid of the new software package.~      The results of the study will be compared with control group data (before the new software~     package was installed or after it was removed) to define a possible contrast reduction.~   "
9876|NCT02927977|"~     The purpose of this randomized clinical trial is to verify the effectiveness of the addition~     of the dry needling in individuals with non-specific neck pain who receive a multimodal~     physical therapy rehabilitation program.~   "
9879|NCT02927938|"~     Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following~     induction chemotherapy. However, a large majority subsequently relapse and succumb to the~     disease. Currently, cytogenetics and molecular aberrations are the best prognostic~     indicators; however, these factors cannot prognosticate accurately for individual patients.~     Overall, the majority of patients with favorable or intermediate-risk AML will experience~     relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less~     than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably~     translate into cure. This study is undertaken to determine whether the presence of LSCs has~     prognostic value as well as to determine whether the presence of LSCs has predictive value.~     This study has an observational component, whereby we intent evaluate whether the presence~     or absence of LSCs is prognostic. This study also has an interventional component in which~     it uses LSC status to determine whether favorable and intermediate risk AML patients in CR~     receive consolidation with chemotherapy or allogeneic HCT.~   "
9880|NCT02927925|"~     The purpose of this study is to assess the clinical efficacy and safety of daratumumab in~     relapsed or refractory natural killer/T-cell lymphomas (NKTCL).~   "
9881|NCT02927912|"~     This phase II trial studies the side effects of intraoperative electron beam radiotherapy~     boost and to see how well it works in treating patients with stage I-II breast cancer~     undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to~     the tumor cavity during the breast surgery before reconstruction may be a better way to kill~     tumor cells and shrink tumors.~   "
9882|NCT02927899|"~     This study is a sensory analysis of several different formulations of a novel~     tomato-soy-arugula seed beverage in men with prostate cancer. Eating a diet rich in a~     variety of fruits and vegetables has been associated with decreased risk of a variety of~     diseases, including prostate cancer. Mixed vegetable beverages may be useful in prostate~     cancer survivorship.~   "
9883|NCT02927886|"~     The objective of the study is to document the clinical efficacy and complications of~     endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative~     and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which~     are close to the placebo.~   "
9884|NCT02927873|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     the respiratory syncytial virus (RSV) candidate vaccine when first administered via~     intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants~     aged 12 to 17 months.~   "
9885|NCT02927860|"~     Show by collecting sleep and activity data, outcomes after thoracic surgery are improved~     with better sleep and increased activity.~   "
9886|NCT02927847|"~     The goal of this study is to evaluate the effects of a smoking cessation intervention~     combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of~     reward function and smoking cessation outcomes. The results of this study will provide~     information about mechanisms contributing to smoking and smoking cessation and will help to~     guide future treatment studies.~   "
9887|NCT02927834|"~     Chronic rhinosinusitis is a common disease that effects millions of people world wide.~     Despite its frequency it is unclear what treatment options are the best for these patients.~     Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a~     long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and~     occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with~     nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal~     of this study to see if oral steroids benefit the treatment outcomes in those patients with~     chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a~     short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a~     difference in outcomes.~   "
9888|NCT02927821|"~     Over 15 million family caregivers provide more than 85% of long-term care to older adults~     with Alzheimer's Disease and Related Disorders. Caregivers typically assume care~     responsibilities without training or support and may in turn experience multiple health~     risks including depression. Providing evidence-based caregiver supportive programs on a wide~     scale basis is identified by the National Alzheimer's Plan Act as a national priority. One~     approach is to augment existing community-based services for older adults with a caregiver~     evidence-based program. Adult day service (ADS) is one such growing and critical~     community-based option for older adults with Alzheimer's Disease and related disorders but~     which does not systematically address common caregiver challenges or burdens using~     evidence-based programs. The purpose of the study is to: 1) evaluate the effectiveness of~     Adult Day Services (ADS) Plus to improve caregiver well-being and reduce depressive symptoms~     compared to routine ADS use at 6 months; and 2) evaluate long-term maintenance effects of~     ADS Plus at 12 months on caregiver well-being and depressive symptoms. ADS Plus consists of~     5 key components: care management, referral/linkage, education about dementia, situational~     counseling/emotional support/stress reduction techniques, and skills to manage behavioral~     symptoms (e.g., rejection of care, agitation, aggression). Based on care challenges~     identified by family caregivers, an ADS Plus Prescription is provided, a written document~     detailing easy-to-use strategies to address specified care challenges and caregivers are~     trained in their use. The proposed study will employ a practical trial design to assess the~     effectiveness and uptake of ADS Plus on a large scale. Thirty ADS programs throughout the~     U.S. varying in geographic location and staffing levels will be involved. A total of 300~     diverse caregivers (150 in 15 ADS Plus sites; 150 in 15 ADS usual care sites) will be~     enrolled.~   "
9889|NCT02927808|"~     This study will investigate the impact of motivational interviewing in achieving low-density~     lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.~   "
9890|NCT02927795|"~     This is a self-controlled study design enrolling consented COPD patients who will be treated~     with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled~     consecutively and will be followed over an observational period of approx. 6 weeks.~   "
9891|NCT02927782|"~     Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache,~     photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous~     wound) after a primary repair should be considered for revision surgery to avoid potentially~     serious complications including CSF (cerebro spinal fluid) fistula formation. Prolonged bed~     rest immediatel after reapir of an ID () incidental durotomy) is widely accepted and~     frequently applied. current literature provides supporting retrospective evidence that~     prolonged bed rest may not be required after watertight closure of dural tears.~      The purpose of this study is to further investigate the impact of prolonged bed rest on the~     need for early reoperation following primary repair of an ID after lumbar spinal surgery.~     The primary endpoint of this study is the difference in reoperation rate between the two~     study groups to further investigate if either one or the other postoperative mobilisation~     regimen provides a significant benefit in terms of persistent dural leakage.~   "
9894|NCT02927743|"~     Inappropriate use of antibiotics in primary care is associated with Development of~     antibiotic resistant strains. As part of a quality improvement program carried out in~     primary care in Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial~     was performed. The aim of the study was to assess whether the use of continuous~     evidence-based feedback about management of respiratory tract infections could decrease use~     of antibiotics in Acute bronchitis, common cold and acute otitis media.~   "
9895|NCT02927730|"~     The main purpose is to evaluate the correlation in qualitative and quantitative manner~     between clinical diagnosis of retained placenta and histology. Secondly, to assess different~     clinical parameters that are likely related to accuracy of the diagnosis of RPOC~   "
9896|NCT02927717|"~     Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab~     containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.~      Also an histological central review is planned in order to re-assess baseline diagnosis~     according to new 2016 World Health Organization (WHO) criteria.~   "
9897|NCT02927704|"~     The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive~     periodontitis (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and~     Generalized AgP (GAgP) to establish its predictive value/role for distinguishing LAgP and~     GAgP development.~   "
9898|NCT02927691|"~     Currently, there are no efficacious behavioral treatment approaches to address uncompensated~     aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD).~     This is of particular public health concern given that aspiration pneumonia is the leading~     cause of death in persons with PD. The overarching aim of the proposed study is to determine~     the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength~     training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway~     protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate~     the results will lead to reductions in the risks associated with airway protective deficits.~   "
9899|NCT02927678|"~     Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic~     therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic~     therapy remains controversy due to the absence of validated marker of osteomyelitis~     remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single~     Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment~     allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was~     associated with recurrence in 70% of cases. The aim of our study was to evaluate~     prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic~     therapy.~   "
9900|NCT02927665|"~     The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM)~     Integrated Dual Balloon System in Obese Subjects.~   "
9901|NCT02927652|"~     The goals of this project are aimed at the following:~        1. Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and~          Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom~          Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and~          patient control an 8 item tool that takes about four minutes to complete.~        2. Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via~          the CG-CAHPS visit survey.~        3. Examining relationships between psychiatric comorbidity and patient satisfaction.~        4. Examining relationships between psychiatric comorbidity and healthcare system use.~   "
9902|NCT02927639|"~     To develop a text messaging intervention using MyDiaText and to determine whether such an~     intervention will decrease HbA1c in children 12 to 18 years old. The intervention will~     consist of daily text messages sent to the subject's personal mobile device. Previously~     developed text messages based on the American Diabetes Association (ADA) behavior goals will~     be used for this intervention. These will be adapted with input from the focus groups that~     will be carried out with adolescents with Type 1 diabetes mellitus (T1DM). The details of~     the intervention, such as frequency and timing of text messages, will be determined from~     input obtained from the focus groups.~   "
9903|NCT02927626|"~     Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma~     basing on immune microenviroment.The purpose of this study is to observe the efficacy of~     routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.~   "
9904|NCT02927613|"~     This study aims to describe the patient characteristics, feasibility, and outcomes of an~     home mechanical ventilation (HMV) program at a university hospital in Thailand.~   "
9905|NCT02927600|"~     The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic~     Responses (GR) interventions at breakfast or at dinner is the most effective for lowering~     glycemic response of the subsequent standard meal.~   "
9906|NCT02927587|"~     Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for~     conscious sedation in flexible bronchoscopy (FB) .However, the target setting of~     effect-site concentration (Cet) of propofol is still unclear in the elderly population~     .The aim of this study was to compare two induction Cet of propofol in elderly patients~     undergoing flexible bronchoscopy.~   "
9907|NCT02927574|"~     Restenosis is still an issue after endovascular revascularization for femoropopliteal~     occlusive disease. One approach to reduce the rates of restenosis and reintervention is~     local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to~     conduct a systematic review and meta-analysis of randomized-controlled trials comparing on~     Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo~     femoropopliteal disease.~   "
9908|NCT02927561|"~     In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk~     for developing complications such as diabetic retinopathy (DR). Due to the increasing~     prevalence of diabetes and high percentage of patients with uncontrolled disease,~     cost-effective tools are needed with focused attention on diabetes prevention and management~     in the current health system. The automatic retinopathy detection can enlarge the screening,~     reducing the workload and costs compared to manual image graders.~   "
9909|NCT02927548|"~     This is a single-center retrospective study that evaluates the effectiveness and long-term~     safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary~     incontinence in women on a population of 500 patients with a mean follow-up of 6 years.~   "
9910|NCT02927535|"~     Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical~     practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over~     5 years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker~     response monotherapy Type of study: Observational cohort study using cross-section and~     longitudinal data.~      Description of the project methodology~        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early~          RA).A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010~          criteria.~        -  Data collected: Patient characteristics, Clinical data regarding RA and related~          pathologies, Characteristics of treatments received The analysis will be conducted~          using data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.~        -  Analyses:~             1. Frequency of use of TNF blockers monotherapy: we will calculate the % of patients~               initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe~               the type of TNF blocker, the route of administration, the dosage, and the place of~               the TNF blockers monotherapy in the treatment strategy during the first 5 years.~             2. Identification of potential predictive factors for initiation of TNF blockers~               monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline~               characteristics of the patients with regard to the initiation of TNF blocker~               monotherapy during the first 5 years of the disease will be compared by univariate~               analysis and Log-rank test will be performed in all variables. A stepwise~               multivariate analysis (Cox analysis) will be performed.~             3. Therapeutical effect: we will calculate the retention rate over time, and will~               compare the changes in different variables in the group of patients who have~               received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3~               patients who have received TNF blockers in combination with synthetic DMARDs. We~               will assess and compare DAS28 and HAQ at short term (after at least 8 weeks of~               treatment) and long term (last available visit) in groups. The structural efficacy~               was evaluated by the radiographic progression at last available visit. We will~               identically estimate the drug effect depending on the TNF blocker used, by~               calculating the retention rate and comparing DAS28 at short term and long term.~             4. Identification of predictive factors for TNF blocker monotherapy response: To~               evaluate the impact of baseline demographics and disease conditions on the DAS28~               and HAQ response during the first 5 years will be compared by univariate and~               multivariate analysis.~      Expected results:~      Increase knowledge on the use of TNF blocker monotherapy, its efficacy and retention rate,~     and on predictive factors for TNF blocker monotherapy response in early RA patients.~   "
9911|NCT02927522|"~     Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase~     the mortality and morbidity. However, the mechanism of POCD is not clear yet and no~     effective therapy method was proved. According to our previous study, the central~     cholinergic system impaired by the anesthesia and surgery play a very important role in the~     POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane~     anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease,~     which is tolerable and has minimal adverse events. In present study a multi-center~     randomized case control study was conducted and we hypothesized that donepezil attenuate the~     POCD.~   "
9912|NCT02927509|"~     Aim: To describe 1) The use of TNF blockers in early arthritis in daily clinical practice in~     France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3)~     To evaluate predictive factors for TNF blocker response Type of study: Observational cohort~     study using cross-section and longitudinal data.~      Description of the project methodology~        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early~          RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010~          criteria.~        -  Data collected: Patient characteristics, Clinical data regarding RA and related~          pathologies, Characteristics of treatments received The analysis will be conducted~          using data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.~        -  Analyses:~             1. Frequency of use of TNF blockers: the % of patients initiating TNF blockers will~               be calculated (Kaplan-Meier method), and the type of TNF blocker will be~               described, the route of administration, the dosage, the association with other~               DMARDs and the place of the TNF blockers in the treatment strategy during the~               first 5 years.~             2. Implementation of EULAR recommendations: the percentage of patients that initiate~               TNF blockers meeting the EULAR criteria for initiation will be estimated, and the~               concordance coefficient Kappa with regard to such fulfilment and the initiation of~               TNF blockers will be calculated, and disease severity outcome measures will be~               compared depending on the fulfilment or not.~             3. Identification of potential predictive factors for initiation of TNF blockers: a~               survival curve (Kaplan-Meier) will be performed. The baseline characteristics of~               the patients with regard to the initiation of TNF blocker during the first 5 years~               of the disease will be compared by univariate analysis and Log-rank test will be~               performed in all variables. A stepwise multivariate analysis (Cox analysis) will~               be performed.~             4. Therapeutical effect:the retention rate over time will be calculated, the changes~               in different variables will be compared in the group of patients who have received~               TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not.~               The DAS28 and HAQ will be assessed and compared at the short term (after at least~               8 weeks of treatment) and long term (last available visit) in groups. The~               structural efficacy was evaluated by the radiographic progression at last~               available visit.The drug effect will be identically estimated depending on the TNF~               blocker used, by calculating the retention rate and comparing DAS28 at short term~               and long term.~           6) Identification of predictive factors for TNF blocker response: To evaluate the~          impact of baseline demographics and disease conditions on the DAS28 and HAQ response~          during the first 5 years will be compared by univariate and multivariate analysis.~      Expected results:~      Increase knowledge on the optimal use of TNF blocker and on predictive factors for TNF~     blocker response in early RA patients.~   "
9913|NCT02927496|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives~     doxycycline look-alike placebo tablets. However, both groups will be enrolled into a~     standardized regimen of hygiene described above. Thus, patients enrolled in the placebo~     group also will receive the current standard of care, and the placebo used in the study will~     help to identify the benefits of doxycycline on a background of simple hygiene measures. The~     regimens will be explained to all participants who will be trained to use established~     standardized methods of hygiene and be effectively applying it prior to the initiation of~     the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A~     common, generic SOP with handouts that describes methods and the training schedule will be~     used so that similar methods are employed across all sites.~   "
9914|NCT02927483|"~     The trial is designed as a randomized, multicenter, open label, comparative, 6 months,~     clinical study.~   "
9915|NCT02927470|"~     The purpose of this study is to understand how the brain allows individuals to keep~     information in mind over brief intervals. During the experiment, participants will be~     asked to maintain fixation while they attend to and remember different visual stimuli (e.g.,~     the location of a dot on the screen, the color of a circle, the orientation of a line, the~     speed of a group of moving dots) on a computer monitor. Participants will make decisions~     about these visual stimuli and indicate their decisions by pressing buttons or making eye~     movements. Through the use of Transcranial Magnetic Stimulation (TMS) investigators hope to~     understand the contributions of different anatomical areas while subjects perform this task.~   "
9926|NCT02927327|"~     The purpose of the study is to collect representative clinical images (head and whole-body~     scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device~     equipped with investigational software components in adult population. The images and~     summary data from this study are intended for use in regulatory submission.~   "
9927|NCT02927314|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in~     subjects with NAFLD and NASH.~   "
9928|NCT02927301|"~     This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant~     atezolizumab in participants with Stage IB, II, or IIIA NSCLC who are eligible for surgical~     resection with curative intent. Neoadjuvant therapy will consist of two 21-day cycles with~     atezolizumab. Following surgery, adjuvant therapy will consist of up to 12 months of~     atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy.~   "
9916|NCT02927457|"~     This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics~     and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic~     cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by~     photoprovocation (PV).~      Current study is two group study. In Group A, Patients with fewer than two active lesions~     will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that~     develop PV lesions at any time during this period, as determined by the local investigative~     team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and~     either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin~     pharmacokinetic (PK) of study drug, for 28 days.~      In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by~     the investigators will be enrolled into group B and have one lesion treated with 1%~     GSK2646264 and 1 lesion with placebo.~      A completed patient will be defined as a subject who receives at least 25 days of study drug~     and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients~     will be followed for 28 days in Group A only or until complete resolution of induced PV~     lesions, as determined by the investigator.~   "
9917|NCT02927444|"~     This study will assess the immunogenicity and safety of booster vaccination with NBP606~     compared to the existing commercial vaccine, when given concomitantly with routine pediatric~     vaccinations.~   "
9918|NCT02927431|"~     Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine~     receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to~     areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being~     developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza~     (IFV). While early therapy with antivirals decreases severity and duration of symptoms of~     influenza, there are no drugs that have demonstrated clinical efficacy in randomized~     clinical trials in this population. Current treatment guidelines for hospitalized IFV~     recommend neuraminidase inhibitors as standard of care therapy. IFV studies in animals have~     demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a~     neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in~     clinical scores, lung function and pathology with no evidence of worsening outcomes,~     including viral load. This Phase 2, randomized, double-blind (for IV DNX),~     placebo-controlled (for IV DNX) 3-arm study will be the first study to determine the~     efficacy and safety of IV DNX when co-administered (in all groups) with standard of care~     antiviral treatment (open-label oral oseltamivir [OSV]) in subjects hospitalized with IFV.~     The primary objective of the study is to assess the efficacy of treatment with IV DNX twice~     daily given with oral OSV compared to oral OSV twice daily on time to clinical response~     (TTCR). In this study, subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg)~     free base equivalent (FBE) IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All~     subjects will also receive open-label 75 mg oral OSV, twice daily (given as standard of~     care). The study treatment duration will be for up to 5 days. The investigator may elect to~     continue treatment with OSV after 5 days of study treatment. Follow up will continue until~     Day 45 for all subjects. The study will begin with enhanced safety monitoring in sentinel~     cohorts, leading to stepwise enrollment of subjects. Subjects will be enrolled based on~     increasing levels of renal impairment, and less severe hospitalized subjects will be~     enrolled prior to enrollment of critically ill subjects, as this is the first study~     conducted in the hospitalized population with severe IFV. Approximately 300 subjects are~     targeted to be enrolled in the study.~   "
9919|NCT02927418|"~     The purpose of this study is to explore the effects of a strength & conditioning (S & C)~     program on risk factors for injury (Y-balance and Functional Movement Screen scores), as~     well as parent reported injury occurrence in 12-16 year old male and female athletes. Forty~     girls and 40 boys aged 12-16 will be recruited; half will participate in supervised S & C~     sessions 2-3x/week while the other half will continue with their regular sports and~     activities. Risk factors for injury and performance indices (20 m sprint and multiple jump~     test) will be assessed before and after the 4 month study. Injury occurrence will be~     recorded via bi-weekly phone calls to the parent and athlete.~   "
9920|NCT02927405|"~     There is an increasing trend on decreasing narcotic use and maximizing efficiency in the~     perioperative care. There are no studies that have compared a TAP block versus a TAP block~     plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin~     and receiving a TAP block decrease post-operative morphine consumption. It will be a~     randomized controlled, double blind study, with 130 patients between 18-60 years; that will~     undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of~     nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful~     because gabapentin will be used to decrease visceral and central pain, and TAP block will~     decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption,~     adverse effects and improve pain management.~   "
9921|NCT02927392|"~     The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The~     investigators have shown that suppressing ovarian function in premenopausal women reduces~     resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). The~     investigators preliminary data suggest that this may be due, in part, to reduced brown~     adipose tissue (BAT) activity. The overarching hypothesis is that BAT activity in humans is~     modulated by E2. To determine if natural declines in endogenous E2 contribute to changes in~     BAT activity, we will compare BAT activity in pre-and post-menopausal women. The~     investigators will also explore whether suppression of ovarian hormones in pre-menopausal~     women impairs BAT activity. BAT activity will be quantified using dynamic positron emission~     topography/computed tomography (PET/CT) imaging combined with 11C-acetate tracers. We will~     assess the thermogenic response of BAT by measuring cold-induced changes in REE, shivering,~     and skin and core temperature.~   "
9922|NCT02927379|"~     This study aims to compare the effects of local wound infiltration with ketamine versus~     dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower~     abdominal cancer surgery.~   "
9923|NCT02927366|"~     This is a non-confirmatory, randomized, subject and investigator blinded, placebo controlled~     study of QCC374 in PAH patients. The study will have 2 parts. In Part 1, an initial safety~     cohort, 8 subjects will be randomized in a 6:2 ratio and the starting dose will be 0.03 mg~     b.i.d.. In Part 2, ~ 30 subjects will be randomized in a 2:1 ratio, with a planned starting~     dose of 0.06 mg b.i.d.. In both Parts, subjects will be up-titrated during the first two~     weeks of the study to 0.12 mg b.i.d, or to their maximum tolerated dose (MTD) if their~     individual MTD is below 0.12 mg b.i.d. during the first two weeks of the study. The~     treatment duration is 16 weeks.~   "
9924|NCT02927353|"~     To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm~     the safety of the study drug in healthy Japanese adult male subjects~   "
9925|NCT02927340|"~     This research study is studying a drug as a possible treatment for ALK-positive or~     ROS1-positive non-small cell lung cancer (NSCLC).~      The following drug will be involved in this study :~        -  Lorlatinib~   "
14032|NCT02873624|"~     The aim of this study is to establish AKI incidence in patients who are undergoing~     laparoscopic cholecystectomy and to identify the potential risk factors associated with the~     development of AKI.~   "
9929|NCT02927288|"~     The purpose of this study is to develop a new test to help diagnose mild traumatic brain~     injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain~     will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the~     investigators will compare the information they obtain from scans of participants with mTBI,~     PTSD or both, to scans from healthy volunteers to understand the differences between these~     groups. If the results can tell the difference between participants with mTBI and PTSD, the~     investigators should be able to help safely diagnose patients in the future.~   "
9930|NCT02927275|"~     The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive~     functioning during activity. Evaluation was accomplished by having participants perform~     standardized cognitive tests while in three forms of low-intensity exercise and then~     comparing results to performance when sitting.~   "
9931|NCT02927262|"~     The purpose of this study is to compare relapse-free survival (RFS) between subjects with~     FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia~     (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or~     placebo beginning after completion of induction/consolidation chemotherapy for a two-year~     period.~   "
9932|NCT02927249|"~     This randomized phase III trial studies how well aspirin works in preventing the cancer from~     coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2)~     breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that~     reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer~     prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast~     cancer.~   "
9933|NCT02927236|"~     Background:~      More effective treatments for people with cocaine use disorder are needed. Researchers want~     to understand the parts of the brain involved in the disorder. Transcranial magnetic~     stimulation (TMS) stimulates parts of the brain. A form of TMS called intermittent~     theta-burst stimulation (iTBS) may help reduce cocaine use. Researchers want to learn how~     the brain might change with treatment.~      Objectives:~      To test if iTBS can reduce cocaine use. Also, to learn how cocaine changes the heart and the~     brain.~      Eligibility:~      Healthy, right-handed adults ages 18-55 who do or do not have cocaine use disorder.~      Design:~      Participants will be screened with:~        -  Questionnaires~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Alcohol breath tests~      In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days~     over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up~     visits. Treatment includes:~        -  iTBS: A coil is placed on the head. A brief electrical current passes through the coil.~          They view cocaine-related images during each session. Sessions are videotaped.~        -  Repeat of screening tests~             -  In the main study, participants will be randomly assigned to have either real or~               fake iTBS.~             -  Participants with cocaine use disorder will join an incentive program to quit.~             -  Participants will have 39 visits over 6 months. These include:~        -  Repeat of screening tests~        -  MRIs at 5 visits: Participants lie on a table that slides into a cylinder that takes~          pictures of the brain. They respond to images while in the scanner.~        -  iTBS at 10 visits (5 days a week for 2 weeks)~      Participants will be contacted throughout the study to discuss iTBS treatment and drug use.~   "
9934|NCT02927223|"~     To test the hypothesis that increasing the sinus node rate with atropine treatment prior to~     exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients~     with CPVT.~   "
9935|NCT02927210|"~     This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men~     to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of~     Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous~     injection.~   "
9936|NCT02927197|"~     The purpose of this study is to examine changes in multiple cognitive skills after~     completing 60 hours of cognitive training with ThinkRx, a LearningRx program.~   "
9937|NCT02927184|"~     This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering~     LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver~     disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of~     the treatment period (Week 12). Secondary endpoints include effects on liver fat content and~     other liver and lipid markers, as well as effects on safety and tolerability, and~     pharmacokinetic (PK) measurements.~   "
9938|NCT02927171|"~     This study seeks to improve rehabilitation methods for restoring physical function with~     skilled nursing facility care. More specifically, this study is designed to evaluate the~     effectiveness of an intensive therapeutic rehabilitation program for older adult skilled~     nursing home residents compared to usual care.~   "
9939|NCT02927158|"~     This study is designed to utilize whole exome and whole genome sequencing techniques to~     identify underlying genetic causes for undiagnosed disorders in the Plain Communities, and~     to do population genetic studies looking at genetic drift and founder mutations in this~     unique population.~   "
9940|NCT02927145|"~     This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI~     trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine~     RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18~     and 45 years.~      Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR~     CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and in~     Oxford for the Phase IIa stage.~   "
9941|NCT02927132|"~     This research seeks to evaluate expressive writing as a novel intervention for problem~     drinking among college students. The vast majority of individually focused brief~     interventions targeting college drinking have focused on personalized feedback approaches~     and recent innovations have largely been limited to finer distinctions of these, which~     require assessment and programming for implementation. The present research proposes~     expressive writing as a novel alternative, which has been used extensively in other domains~     but not as an alcohol intervention strategy.~      H1a: Participants writing about negative drinking events will show reduced drinking and~     drinking-related negative consequences relative to students in the neutral control group.~      H1b: Participants writing about distressing non-alcohol events will show increased~     psychological wellbeing relative to students in the neutral control group.~      H1c: Participants writing about negative drinking events will show reduced drinking and~     consequences compared with an empirically-supported brief intervention (i.e., PNF). This is~     an exploratory hypothesis.~      H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress~     narratives.~      H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to~     all other conditions.~      H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will~     mediate intervention effects on drinking outcomes.~      H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.~   "
14033|NCT02873611|"~     Estimation of the localization accuracy of the genicular ablation procedure applied for~     chronic pain suppression~   "
9944|NCT02927093|"~     The Shoklo Malaria Research Unit (SMRU) provides care to refugees and migrant populations~     along the Thai-Burma border since 1986. Services include antenatal and birthing care, with~     2,500 births per year and Special Care Baby Units (SCBU) set up in 2008; all medical records~     including clinical and laboratory data are archived. The treatment of neonatal jaundice is~     based on treatment thresholds adapted from the neonatal jaundice guidelines, published by~     the Royal College of Obstetricians and Gynaecologists, UK. Total serum bilirubin (SBR) is~     done at regular intervals to monitor neonatal hyperbilirubinemia (NH) evolution, following~     SMRU guidelines. The SCBU have been set up to provide intensive care for neonates in a~     resource constrained setting and don't have equipment for assisted ventilation other than~     oxygen therapy. Neonates presenting with high serum bilirubin levels and/or clinical signs~     of acute bilirubin encephalopathy (ABE) cannot receive exchange transfusion on site and have~     to be referred to the Thai general hospital one hour drive from the clinics; and, for those~     neonates surviving, there has not been a systematic follow-up of their growth and~     neurodevelopment.~      The study will consist of a matched case-control series and a retrospective review of SCBU~     charts of neonates with NH reaching exchange transfusion threshold. The SCBU database will~     be searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy~     between January 2009 and December 2014; charts will be manually researched to identify study~     participants which will be classified as NH reaching exchange transfusion threshold (cases)~     or as NH within moderate threshold (controls). Additionally neurological signs compatible~     with ABE will be searched in the clinical notes and coded as present/absent. Cases~     discharged alive from the SCBU will be traced back to evaluate their clinical and~     neurocognitive long term outcome. Each case will be matched with a moderate NH control from~     the same clinic, sex, gestational age and season of birth and hospitalized within the same~     month.~      The results of this study will help to improving the clinical care during the neonatal~     period and to developing a guideline for a better follow-up of children with NH reaching~     exchange transfusion threshold.~   "
9945|NCT02927080|"~     Study A083-02 is a multicenter, Phase 2 study to evaluate the safety, tolerability,~     pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of ACE 083 in patients with FSHD~     to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is~     randomized, double-blind, and placebo-controlled.~   "
9946|NCT02927067|"~     The purpose of this study is to compare the efficacy and safety of maribavir to~     valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic~     hematopoietic stem cell transplant recipients.~   "
9947|NCT02927054|"~     A questionnaire was provided, including clinical vignettes and free text answers, to assess~     and evaluate the ability of resident physicians to identify systemic inflammatory response~     syndrome (SIRS), sepsis, and severe sepsis. Questionnaire scores were compared between~     specialties. A whole-hospital educational campaign was provided with the aim to improve~     sepsis recognition, and the questionnaire survey was repeated after one year to assess the~     effect of the education on the recognition of sepsis.~   "
9948|NCT02927041|"~     The gold standard in hemodynamic evaluation has been the combined use of echocardiography~     and right heart catheterization. Fall backs to echocardiography are its time consumption and~     requirement for specialist interpretation while the Swan-Ganz® catheter shows a poor~     correlation of central venous pressure to volume status and provides indirect and difficult~     to interpret measurements in patients with unique pathophysiological states.~      Next generation continuous hemodynamic transesophageal echocardiography (hTEE®) is being~     increasingly utilized to assist with complex resuscitations and to monitor the hemodynamic~     profiles of critically ill patients. hTEE is proving to be an essential diagnostic,~     therapeutic and monitoring tool for the rapid evaluation of the hemodynamic state in the~     critically ill patient and or hemodynamically compromised patient.~      The purpose of this observational study is to evaluate the role of hTEE in clinical~     decision-making in 30 patients recruited from OR-Trauma and in 30 patients from the~     Cardiovascular-OR. Hemodynamic trans-esophageal echocardiography (hTEE) incorporates an~     FDA-approved miniaturized, disposable probe for continuous use in patients for up to 72~     hours. This device has been used for postoperative assessment in the ICU for several years~     with successful placement of probes and without any adverse incidents.~      The probe allows for the rapid, intermittent or continuous evaluation of bi-ventricular~     function, volume status and valve function at bedside or intraoperatively. It also allows~     for the evaluation of pericardial effusions and or the exclusion of pericardial tamponade.~   "
9949|NCT02927028|"~     With an emphasis on oral processing, this study seeks to characterize the mechanisms that~     account for the high satiation properties of walnuts and low energy yield during digestion.~   "
9950|NCT02927015|"~     Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release~     from products in a pilot human study.~   "
9951|NCT02927002|"~     The goal of this project is to study the effect of noninvasive brain stimulation on~     decision-making and on brain activity in impulse control disorders.~   "
9952|NCT02926989|"~     The main objective of the trial is to evaluate the risk of hypokalemia following~     administration of a isotonic solution compared to a hypotonic solution in acutely ill~     hospitalised children, who need intravenous fluid therapy.~   "
9953|NCT02926976|"~     The Optimal Treatment for Treatment-resistant Schizophrenia~   "
9954|NCT02926963|"~     Chronic granulomatous disease (CGD) is a rare genetic disease of innate immune due to the~     malfunction of phagocytic cells unable to destroy pathogens during infection. The four genes~     implicated are CYBB, CYBA, NCFA and NCF2 respectively encoding Nox2, p22phox, p47phox and~     p67phox. Nox2 analogs have recently been discovered in cells other than phagocytes. So the~     question arises on physiopathological impact of the absence of theses proteins not only in~     phagocytes but also in other cells types such as fibroblasts or neurons.~      The principal objective is thus to study the impact of protein deficits Nox2 and p22phox, in~     the pathophysiology of neurons from inducible pluripotent bone marrow cells (iPSC).~      For this purpose, a collection was built of fibroblasts and keratinocytes from patients with~     different forms of CGD to get iPSC similar to embryonic marrow cells and differentiable into~     several cell types (neurons, phagocytes).~   "
9955|NCT02926950|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c)~     reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control with~     metformin.~      Secondary Objectives:~        -  To compare sotagliflozin versus placebo for:~        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.~        -  Change from baseline in fasting plasma glucose (FPG);~        -  Change from Baseline in systolic blood pressure (SBP) for patients with baseline SBP~          ≥130 mmHg;~        -  Change from baseline in systolic blood pressure (SBP) for all patients;~        -  Change from baseline in body weight;~        -  Proportion of patients with HbA1c <6.5% and <7.0%.~        -  To evaluate the safety of sotagliflozin versus placebo.~   "
10459|NCT02920346|"~     The purpose of the research study Heart Sounds at Home is for pregnant SSA or SSA/SSB~     (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to~     detect abnormal heart rates and rhythms in their babies before they are born.~   "
9956|NCT02926937|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c)~     reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on~     diet and exercise.~      Secondary Objectives:~        -  To compare sotagliflozin versus placebo based on:~        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;~        -  Change from baseline in fasting plasma glucose (FPG);~        -  Change from baseline in body weight;~        -  Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP~          ≥130 mmHg;~        -  Change from baseline in SBP for all patients;~        -  Proportion of patients with HbA1c <6.5%, <7.0%.~        -  To evaluate the safety of sotagliflozin versus placebo.~   "
9957|NCT02926924|"~     This is a prospective randomized study evaluating the use of a prophylactic incision wound~     vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a~     BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs.~     vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the~     interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be~     antibiotics or return trip needed to the operating room for wound related complications.~      The patients only intervention would be the application of an incisional wound vac. The will~     be no change in the patients postoperative protocol otherwise. This procedure is~     noninvasive.~   "
9958|NCT02926911|"~     This study looks at the risks and benefits of active surveillance (AS) compared to guideline~     concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low~     risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in~     Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes~     compared to GCC.~   "
9959|NCT02926898|"~     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a~     single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when~     added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young~     adults with Dravet Syndrome~   "
9960|NCT02926885|"~     Evaluation of a new technique of liver retraction for the exposure of the His angle in~     gastric bypass Roux-en-Y surgery.~   "
9961|NCT02926872|"~     The primary outcome of this study is the development of a clinical profile of pediatric~     patients with LAL-D, which will enable the Sponsor to provide more focused guidance to the~     medical community as to which pediatric patients should be tested for LAL-D.~   "
9962|NCT02926859|"~     Current antipsychotic treatments of schizophrenia are only partially effective, and their~     use is often associated with serious side effects. Cannabidiol is a natural counterpart of~     the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no~     psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol~     versus amisulpride in acute paranoid schizophrenia we showed a statistically significant~     clinical improvement in all symptoms clusters of schizophrenia compared to baseline with~     either treatment. Cannabidiol displayed a significantly superior side-effect profile in~     particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The~     favorable side-effect profile and potentially novel mechanism of action identify this~     molecule as a potential antipsychotic. However, long-term safety and efficacy data is still~     lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol~     in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an~     established treatment with either quetiapine or amisulpride, in a 12-months, double-blind,~     parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on~     cannabidiol's antipsychotic potential will be gained.~   "
9963|NCT02926846|"~     This is a randomized controlled trial to evaluate whether a switch to intravenous~     antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis~     related peritonitis.~   "
9964|NCT02926833|"~     This is a phase 1-2, open-label study in subjects with refractory DLBCL, evaluating the~     safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR) T~     cell therapy, in combination with atezolizumab, a humanized, monoclonal antibody that binds~     to PD-L1 and blocks interaction with the PD-1 and B7.1 receptors. The trial will be~     separated into two distinct phases designated as phase 1 and phase 2.~   "
9965|NCT02926820|"~     There is a paucity of investigation into effective interventions to enhance cognitive~     function and/or mitigate cognitive decline in individuals with Huntington disease (HD). This~     study targeted working memory (WM), which is the ability to actively hold information in the~     mind in order to perform complex mental tasks, given reports of WM dysfunction in patients~     with HD. The investigators examined the feasibility of conducting a 5-week WM training~     program (Cogmed). Patient adherence and treatment tolerance were assessed. In addition,~     preliminary evidence for the efficacy of this training program on targeted cognitive~     abilities was examined. Nine patients with pre-manifest or early stage HD underwent~     training. Patients were assessed before the intervention and one week after completion.~   "
9966|NCT02926807|"~     A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD~     matched for sex, age and coronary artery disease risk factor with the AD subjects will also~     be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to~     quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate~     the Agatston score. Skin and blood biomarkers will also be assessed.~   "
9967|NCT02926794|"~     Two hundred and ninety-three college students who reported drinking in the past month were~     randomly assigned to condition in a 2 (self-affirmation: values vs. control writing task) x~     2 (implementation intentions: formed vs. not formed) between-subjects factorial design.~     Participants first completed a self-affirmation or control writing task, then read an~     article describing the risks of drinking. Next, all participants reported their common~     drinking behaviors and contexts, and then selected two harm-reduction strategies making~     either general intentions to use the strategies or making implementation intentions to use~     the strategies. Alcohol consumption was measured 1 and 2 weeks after the experimental~     session.~   "
9968|NCT02926781|"~     Radiographic evaluation of the amount of bone height gain and clinical evaluation of the~     possibility of developing complications after transcrestal sinus floor elevation using~     drills and the conventional osteotome technique.~   "
33614|NCT02617082|"~     This study is designed to evaluate the feasibility and safety of partial breast irradiation~     for low risk DCIS after breast-conserving surgery.~   "
9969|NCT02926768|"~     CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively~     targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type~     (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety~     profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended~     Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in~     previously treated NSCLC patients known to have the T790M EGFR mutation.~   "
9970|NCT02926755|"~     The goal of this study is to use three (3) different imaging techniques:Fractional Flow~     Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is~     more reliable than pictures alone to determine the significance of blockages in the heart;~     Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about~     the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence~     Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque~     thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have~     suffered a recent heart attack, underwent successful opening of the artery with a stent, and~     have blockages greater than or equal to 50% in one or more of the other arteries to the~     heart; and to correlate this findings with cardiovascular outcomes at 1 year.~   "
9971|NCT02926742|"~     This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using~     EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE~   "
9972|NCT02926729|"~     This research is studying a new investigative imaging instrument called a nonlinear~     microscope (NLM). A nonlinear microscope can produce images similar to an ordinary~     pathologist's microscope, but without first processing tissue to make slides. This study~     will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast~     cancer in order to reduce the probability that standard pathologic examination of the~     specimen after the end of the operation will find close or positive margins, thus possibly~     requiring the patient to have additional breast surgery.~   "
9973|NCT02926716|"~     As the proportion of early gastric cancer has been steadily increased in Korea, so has~     function-preserving surgery. The function preserving surgery is characterized by the~     minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter~     than those of standard gastrectomies.~      Currently, there is only one way to identify resection margin status in gastric cancer,~     'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition,~     the results rely on the pathologist's expertise, thereby it showed limitation of its~     accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous~     study.~      Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated~     that this emerging technique is useful to identify the gastric tumor margin more clearly in~     vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that~     NBI may allow reliable delineation of tumor and identification of resection margin status in~     the specimen after gastrectomy for gastric cancer.~   "
9974|NCT02926703|"~     The investigators compared the feasibility of serum creatine kinase and serum lactate~     concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures~     (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the~     emergency departments.~   "
9975|NCT02926690|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167~     administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or~     metastatic breast cancer.~   "
9976|NCT02926677|"~     This study is designed to examine three treatment conditions for traumatized youth:~     Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and~     Treatment as Usual (TAU) to determine which treatment works most effectively for which~     youth. The investigators would like to determine feasibility of training on the treatment~     interventions. In addition, this study aims to inform development of systems of care for~     chronically traumatized youth.~      The investigators hope to determine whether 1) TF-CBT and CCT will have better outcomes than~     TAU, 2) Child characteristics predict better outcome in either TF-CBT or CCT and to identify~     which phases of treatment are most effective, and 3) Imaging findings will be predictors of~     improved outcome. This research is important because while there are many existing trauma~     interventions for youth, little is known about what is most essential in those~     interventions. This study will shed light on what components of treatment are most~     effective. Furthermore, there are minimal guidelines on how to select the most appropriate~     intervention for a particular child. This study will contribute to that knowledge by~     informing which interventions are suited best for which youth.~   "
9977|NCT02926664|"~     The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure~     Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of~     Sepsis, i.e. an initial qSOFA of at least of 2.~   "
9978|NCT02926651|"~     As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose~     regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to~     determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in~     hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following~     primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk~     for transfusion. The investigators hypothesize that a multi-dose TXA regimen will~     significantly minimize post-operative blood loss and transfusion requirements compared to~     the use of a single dose regime.~   "
9979|NCT02926638|"~     This randomized phase II/III compares rilotumumab when given together with erlotinib~     hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV~     squamous cell lung cancer that has come back after previous treatment. This is a sub-study~     that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte~     growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow~     more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib~     hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in~     treating squamous cell lung cancer.~   "
10483|NCT02920034|"~     Prospective, randomized trial to assess the effectiveness of different renal sympathetic~     denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a~     cohort of patients with therapy refractory arterial hypertension and large renal arteries~   "
9980|NCT02926625|"~     Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a~     febrile child presents to a community health worker (CHW), the child is assessed for~     malaria, pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for~     integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1)~     there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled~     out, the World Health Organization (WHO) recommends that all children be reassessed in 3~     days. It is hypothesized that health outcomes for these cases will be equivalent if the CHW~     advises to come back in 3 days only if symptoms have not resolved. In order to assess this~     hypothesis, a two-arm cluster-randomized, community-based non-inferiority trial in Southern~     Nations, Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be~     conducted to assess the non-inferiority of CHW-advised systematic follow-up on day 3~     compared to conditional follow-up for non-severe febrile illness in children age 2 to 59~     months, in which no cause of fever can be identified and where danger signs are absent.~   "
9981|NCT02926612|"~     This is a multicenter prospective collection of leftover respiratory tract secretions,~     paired blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed~     by next generation genomic sequencing, transcriptome analysis, protein biomarker~     measurement, and statistical modeling.~   "
9982|NCT02926599|"~     Simulated environment allowed safe learning of critical events and knowledge of appropriate~     response and treatment. Anesthesiology resident education curriculum in Lyon plans several~     high fidelity simulation session with a large panel of critical events. Anticipation of~     critical events before they may occur and planification of team resources and priority in~     the treatment strategy may help to improve team performance during the scenario. The~     investigators' goal is to compare individual and team performances with or without an~     optimization personal potential training.~   "
9983|NCT02926586|"~     The purpose of the study is to determine whether Fludarabine in combination with cytarabine~     is more effective than high-dose cytarabine in post-remission therapy for patients with~     core-binding factor acute myeloid leukemia~   "
9984|NCT02926573|"~     The study will involve adult otolaryngology patients over the age of 18 years undergoing~     open or endoscopic/robotic tumor resection involving the mucosal surfaces of the oral~     cavity, oropharynx, hypopharynx and larynx at Washington University Medical Center. Eligible~     patients will be recruited from the otolaryngology head and neck cancer clinic during~     preoperative visits. Participants will be randomized to active or placebo drug and will~     receive study drug twice a day from Post-Op Day 0 and conclude Post-Op Day 2. Questionnaires~     will be collected pre-and post-operatively.~   "
9985|NCT02926560|"~     The aim of this study is~      1) To describe the level and determinants of methotrexate adherence in patients with chronic~     inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in~     the department of rheumatology in the Nîmes University Hospital~   "
9986|NCT02926547|"~     1. Identify the tissue proteins associated with early breast cancer invasion phases~          without lymph node involvement .~        2. Consider their role in the invasion and the risk of tumor spread .~   "
9987|NCT02926534|"~     The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59~     years based results of spirometry before and after bronchodilator, presence of structural~     changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large~     and small airways)detected by computer tomography as well as the symptoms of COPD. The study~     has three study groups: smokers of conventional cigarettes; those who had quit smoking 1 - 5~     years ago, and those who haven't smoked cigarettes.~   "
9988|NCT02926521|"~     The investigators' objective is to evaluate whether any of the various peripheral nerve~     block catheter dressing strategies currently employed by the Boston Children's Hospital~     Regional Anesthesia Service has any differential impact on specific outcome endpoints such~     as regional block catheter dislodgement, catheter occlusion, catheter leakage, skin~     irritation, and skin infection.~   "
9989|NCT02926508|"~     Recently, there has been an emerging interest in how manipulating gut microbiota (which is~     composed by microorganisms living in our digestive system) can influence learning, memory~     and cognition. This influence is thought to primarily occur via the gut endocrine and immune~     systems, and the vagus nerve, all of which influence brain function and are modulated by~     intestinal microorganisms. One way to manipulate the microbiota is to ingest dietary~     compounds, such as prebiotics.~      Prebiotics are non-digestible dietary fibres that enhance the growth of healthy bacteria~     in the intestines when given in adequate amounts. Prebiotics are relatively stable, can be~     stored at room temperature and can be easily added to foods or drinks. They are not degraded~     by enzymes and acids in the digestive tract; therefore they reach the colon relatively~     unchanged, where they are metabolised by specific bacteria, thus promoting their beneficial~     effects. Prebiotics can be found in very small proportions in vegetables and fruits such as~     leeks, onions, tomatoes, garlic, etc., but this naturally occurring quantity is generally~     insufficient to promote a significant growth of beneficial bacteria. Therefore, large~     quantities of purified prebiotics are available as powder supplements and sold in packages~     of the appropriate dose.~      Pre-clinical studies in animals have shown that prebiotics modulates brain expression of key~     molecules involved in cognition and brain health in rats. These findings therefore highlight~     the potential of influencing cognition through the manipulation of gut microbiota (in this~     case, via the ingestion of a prebiotic).~      Building on this evidence, the aim of this study is to investigate how manipulating gut~     microbiota can influence reading, learning and behaviour in a group of children whose~     reading scores suggest there is room for improvement.~   "
9990|NCT02926495|"~     Hypertension is a serious public health issue, affecting approximately 30% of adults.~     Hypertension greatly contributes to the risk for heart disease and stroke, both among the~     top three leading causes of death in the Americas, Europe, and Asia. While most treated~     individuals with hypertension are controlled on medication, diet and exercise, an estimated~     12% are resistant to conventional medical intervention. Alternative effective treatments are~     still needed for this hypertensive patient population to mitigate the risk and incidence of~     mortality and morbidity.~      This original Investigational Device Application is for a study intended to confirm the~     safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin~     system to treat resistant hypertension. The eCoin device delivers electrical stimulation~     pulses to the median nerve from a small coin sized device placed under the skin of the~     distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous~     studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin~     therapy has previously been demonstrated in a multinational, randomized, double-blind,~     sham-controlled study in New Zealand, Taiwan and Canada.~      This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled~     study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with~     drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted~     subcutaneously in the right and left forearms of patients with uncontrolled hypertension~     despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing~     period, subjects will be 1:1 randomized into either a treatment or control group. One half~     of the subjects have their devices activated (treatment) and the other half undergo a sham~     activation (control) to maintain participant blinding to their treatment allocation. During~     the six months post-randomization, the eCoin is ON in the treatment group and OFF in the~     control group.~   "
10484|NCT02920021|"~     The purpose of this study is to determine ANB020 safety, tolerability and activity in adult~     patients with peanut allergy.~   "
9991|NCT02926482|"~     This is a cluster-randomized controlled trial designed to increase the availability of~     buprenorphine treatment slots in specialty addiction treatment organizations to treat opioid~     use. The intervention being tested is a bundle of buprenorphine prescriber capacity building~     practices called the Physician Recruitment Bundle (PRB). For the study, 70 organizations~     will be identified and recruited, and those organizations will then be randomized into one~     of two arms: 1) control, and 2) PRB: organizations implementing the PRB using the Network~     for Improvement of Addiction Treatment (NIATx) Organizational Change Model. The primary~     research question is to test the impact of the PRB, relative to the control, on increasing~     the number of assigned physician buprenorphine slots in specialty addiction treatment~     organizations.~   "
9992|NCT02926469|"~     The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual~     Reality (VR) during labor. We will also explore whether VR distraction is helpful for~     reducing subjective pain during labor, even if this pain is severe or excruciating. We~     predict that VR is feasible in this setting and that VR distraction will reduce acute pain~     and anxiety during labor.~   "
9993|NCT02926456|"~     The purpose of this study is to describe the effectiveness of darunavir/cobicistat~     (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after~     baseline, defined as the day when the treatment with DRV/c-based regimen is started, through~     collection of daily practice data in the Italian setting.~   "
9994|NCT02926443|"~     The shoulder is the most mobile joint in the body but still has the responsibility of~     ensuring a strong stability of our upper limbs during daily activities. The shoulder joint~     therefore requires a significant level of neuromuscular control at all times. The shoulder~     heavily relies on 4 key stabilizing muscles, known as the rotator cuff complex (RC). A~     tendinopathy of the RC may cause pain, significant muscle weakness, and a decrease in motor~     control of the shoulder during functional activities as well as work tasks. Individuals who~     have an RC tendinopathy often have neuromuscular and proprioceptive deficits. The objectives~     of this study are to evaluate the effectiveness of a brand new strength and motor control~     exercise program for the upper extremities and to compare the effectiveness of this program~     to usual physiotherapy care (such as manual therapy, motion exercises, strengthening, manual~     techniques) in reducing shoulder pain and improving overall function. A total of 44~     participants suffering from an RC tendinopathy will be recruited; 22 will be assigned to the~     exercise group (EXP) and 22 participants will be receiving usual physiotherapy care (CTL).~     Participants in the EXP group will partake in the new exercise program 3 times / week for 6~     weeks whereas participants in the CTL group will receive usual physiotherapy treatments~     twice / week with home exercises for 6 weeks. The results of this study will provide~     clinicians with a cost-effective and innovative treatment approach to treating shoulder~     pain. This study will provide active rehabilitation guidelines for reducing shoulder pain~     and the incidence of recurrence.~   "
9995|NCT02926430|"~     The purpose of this study is to assess the safety and tolerability of 2 single doses of~     either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered~     intramuscularly to elderly adults given at least 12 months apart.~   "
9996|NCT02926417|"~     The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients~     undergoing major surgery. The investigators will identify then correlate soluble biomarkers~     in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.~   "
9997|NCT02926404|"~     Retro-prospective study allowing inclusion of patients with spinal deformities treated by~     patient-specific rods (UNiD).~      This study aims to assess performance, clinical outcomes and safety~   "
9998|NCT02926391|"~     Multicenter study allowing to include the first sixty patients implanted with a custom-made~     corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients~     implanted in thoracolumbar region.~      The main objective is to confirm feasibilty and safety of patient-specific implants for one~     or multi-level corpectomy and fusion.~      This study was approved in March 2016 allowing to include retrospectivley all patients since~     the first implantation in January 2015 and prospectively all patients after the approval.~   "
9999|NCT02926378|"~     Based on the evidence, a pre-post test pilot study design will be implemented to clarify the~     benefits of an acupuncture intervention before and after treatment. The initial assessment~     will contain a brief demographic interview and a review of medical records, and both pre and~     post-intervention evaluations will comprise an imaging protocol that includes RS-fMRI,~     pCASL, diffusion kurtosis imaging (DKI), and a brief cognitive assessment, as described in~     greater detail below. Several quantitative measures within DMN regions will be generated and~     compared between pre- and post-acupuncture therapy. These include 1) RS-fMRI measures such~     as connectivity strength and fractional amplitude of low frequency fluctuations (fALFF); 2)~     regional CBF measured with pCASL; 3) water diffusion measures for microstructural changes~     with DKI.~   "
10000|NCT02926365|"~     The purpose of this study is to test internet-delivered cognitive behavior therapy for~     children and adolescents with anxiety disorders and obsessive-compulsive disorder in a~     routine clinical setting in a rural part of Sweden.~   "
10001|NCT02926352|"~     There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy~     (LLLT) can enhance the efficacy of fear extinction training in the modification of~     pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as~     a stand-alone intervention for anxiety/phobias.~   "
10002|NCT02926339|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to~     either receive 3 anti-tobacco presentations or 3 presentations on a different topic,~     unrelated to tobacco.~   "
10003|NCT02926326|"~     An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197~     exposure in healthy male subjects.~   "
10004|NCT02926313|"~     A randomized control study aimed to investigate if suitable individualized seating provision~     is effective for adult nursing home residents in reducing the incidence of pressure ulcers,~     and increasing their quality of life and functioning.~   "
10005|NCT02926300|"~     The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients~     who has history of FURESTEM-CD injection at least once.~   "
10498|NCT02919839|"~     Personalized medicine methods in the management of type 1 diabetes~   "
10006|NCT02926287|"~     Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ~     prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.~      Secondary objectives are AS rate in the overall population and reasons for ineligibility or~     failure of ambulatory surgery.~      This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.~      A randomized control study will follow PCAP study.~   "
10007|NCT02926274|"~     Massive hemorrhage is a major cause of potentially preventable death following trauma. A~     common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy,~     leading to death from exsanguination. Even when bleeding is controlled, patients are at~     increased risk of complications and mortality. Reconstituted whole blood, or component~     therapy with packed red blood cells (PRBCs), plasma, and platelets was introduced by the~     military in recent conflicts in Iraq and Afghanistan with remarkable results and has been~     adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that~     transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of~     high plasma volumes may be associated with increased risk of allergic reaction, transfusion~     associated acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory~     distress syndrome (ARDS). Military services have recently reintroduced fresh whole blood~     (FWB) for standard resuscitation of massive hemorrhage, have found that FWB offers a~     survival advantage over component therapy, and that risks of transfusion reactions are~     similar for FWB and PRBCs. On the civilian side, whole blood is an FDA-licensed product that~     has been in use in pediatric open heart surgery and autologous blood donation but is no~     longer commonly available for other indications. However, the military results are renewing~     interest in whole blood for trauma resuscitation. The use of low-antibody titer whole blood~     leukoreduced with a platelet-sparing filter was recently approved by the University of~     California Los Angeles Blood and Blood Derivatives Committee and two other trauma centers~     for male trauma patients. This study will test the feasibility of providing FWB for~     resuscitation of patients in hemorrhagic shock and determine the effects of FWB on clinical~     outcomes as well as the effects on coagulation, fibrinolysis, and inflammation, compared to~     standard blood component therapy.~   "
10008|NCT02926261|"~     Nutritional status in patients with cirrhosis has been shown to have a direct influence on~     the prognosis of these patients, it is related to higher mortality and it has been linked to~     the developement and perpetuation of certain complications such as hepatic encephalopathy,~     ascites and spontaneous bacterial peritonitis.~      Despite the importance of nutritional status in this patients, most of the methods for its~     assessment are still not completely reliable or not easily accessible; therefore, evaluating~     nutritional status in the daily clinical practice is still a complex task.~   "
10009|NCT02926248|"~     The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA~     patients at 3 months following a manipulation under anesthesia.~   "
10010|NCT02926235|"~     The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle~     atrophy and malnutrition compared to a placebo in patients following a total knee~     arthroplasty. The investigators specific objectives included analysis of (1) muscle~     strength, (2) change in malnutrition, (3) perioperative complications (4) physical activity.~   "
10011|NCT02926222|"~     This study aims to evaluate the role of Regorafenib in prolonging the overall survival of~     glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or~     without bevacizumab.~   "
10012|NCT02926209|"~     This will be a prospective multi-center, multi-national comparative non-blinded clinical~     investigation. Each subject will undergo back-to-back tandem colonoscopies with the~     Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem~     colonoscopy study, each subject will serve as their own control. The 1st procedure will be~     randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The~     same investigator will perform both procedures on each subject. All pathologies found will~     be either removed or tattooed. Unmarked pathologies found on second pass will represent~     those missed during the 1st pass, thus making the subject and the control one and the same.~     Tattooed pathologies that can be removed endoscopically will be removed in an additional~     colonoscopy. This may occur if a large polyp cannot be removed for any reason with the~     Aer-O-Scope, but can be removed with conventional colonoscopy.~   "
10013|NCT02926196|"~     Randomized trial that compares, with the clinical practice monitoring, an adjuvant or~     neoadjuvant treatment with an anti PD L1 antibody in breast cancer patients with negative~     receptors~   "
10014|NCT02926183|"~     Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international~     oncology meeting and represents a new standard regimen in the treatment of metastatic~     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy~     on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen~     includes only two cycles (three times weekly and one week rest) of GA regimen.~   "
10015|NCT02926170|"~     Long-term anticoagulation is widely used for secondary thromboprophylaxis in the~     antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently~     anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have~     unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment.~     Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and~     safe compared with warfarin for the treatment of venous thromboembolism and non valvular~     atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study~     is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis~     in patients with APS compared with acenocumarol~   "
10016|NCT02926157|"~     The purpose of this study is to investigate whether a comprehensive group education combined~     with a lifestyle activation program that includes (a) sleep hygiene course, (b) physical~     activity promotion, and (c) bright light therapy, can improve both sleep quality and~     cognitive function among 96 community-dwelling older adults.~   "
10017|NCT02926144|"~     The main objective of this study is to compare the proportion of tracheal intubations for~     which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.~   "
10018|NCT02926131|"~     This is an observational prospective study. The main purpose is to evaluate the stability of~     the Bilistick system in a humid and hot climate compared to the quantitative test for serum~     bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a~     controlled environment.~      The secondary aim is to assess the operational feasibility of the Bilistick system in a~     tropical limited-resource setting, when used by locally trained nurses.~   "
10019|NCT02926118|"~     This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in~     the interstitial fluid) during a dietary intervention using meals with either a high with a~     low glycemic load.~   "
10499|NCT02919826|"~     To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to~     individuals with ID and emotional dysregulation.~   "
10020|NCT02926105|"~     This study compares the effects of three home-based exercise programmes in at-risk to~     falling older adults living in their own home on the incidence of falls (number and~     severity), risk factors, and quality of life as well as on the adherence to exercise. The~     subjects will be randomized and allocated in three groups. The group A will receive the~     Test-and-Exercise home-based programme (T&E), the group B will receive the Otago~     home-based exercise programme and the group C (activ-control group) will receive the~     Helsana booklet~   "
10021|NCT02926092|"~     The purpose of this study is to gain an understanding of how adRP progresses over time in~     patients with misfolded rod opsin mutations.~   "
10022|NCT02926079|"~     This proposed study; Investigation of mechanisms for transmission of impaired glucose~     metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis~     that impaired maternal substrate oxidation (metabolic inflexibility) and placental~     lipotoxicity are characteristics of diabetic pregnancies and in utero development within~     these conditions programs a metabolically inflexible phenotype in the offspring.~   "
10023|NCT02926066|"~     This clinical trial expansion is to offer patients, who are not enrolled into the Phase I/II~     trial, a chance of treatment, to extend the experience in this gene therapy, and to increase~     the dosage slightly to waive the drug dilution procedure.~   "
10024|NCT02926053|"~     Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved~     impressive clinical results with durable complete responses in patients with metastatic~     melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro~     expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1~     week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL~     infusion Interleukin-2 is administered to support T cell activation and proliferation in~     vivo.~      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,~     including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with~     metastatic Renal Cell Carcinoma.~   "
10025|NCT02926040|"~     A. Pancreatic cancer background In 2012, 1,172 new pancreatic cancer patients were diagnosed~     in Switzerland. Only 20% of the patients with newly diagnosed pancreatic cancer are~     candidates for surgical resection, the only potential treatment for cure. Over 30% of the~     patients initially present with locally advanced disease. Patients with locally advanced~     disease have no evidence of metastatic spread to the liver, lung, and peritoneum but present~     with local involvement of vital structures that prohibits reasonable tumor resection.~     Currently, those patients are evaluated for palliative chemotherapy +/- radiation therapy.~     However, even with best conventional medical therapy, median survival of patients with~     locally advanced disease is mostly below 1 year. Over the last years, loco-regional~     therapies gained increased attention including radiofrequency-, cryo-, and microwave~     ablation as well as electrochemotherapy. However, all those entities are criticized by their~     complication rates leading to morbidity and mortality, limited area of application given the~     complex anatomical structures around the pancreas, and ill-defined improvements in overall~     survival.~      B. Irreversible electroporation (IRE):~      Irreversible electroporation is an emerging ablative modality that gained enormous interest~     over the last five years. For locally advanced pancreatic cancer, it was introduced in 2009.~     IRE is mainly non-thermal and primarily works through apoptosis. Its well studied safety~     profile allows ablation also within the context of locally advanced pancreatic cancer given~     it mainly spares vessels from destruction.~      Increasing evidence shows that IRE for locally advanced, unresectable pancreatic cancer is~     effective compared to historic controls with a significant prolongation of local progression~     free survival, distant progression free survival and overall survival. The improvement in~     overall survival is about double the amount of what is seen with best new chemotherapy and~     chemoradiation regimens used at the present time. Those results are even more impressive~     given the discouraging improvements among palliative systemic options.~      The NanoKnife IRE device (Angiodynamics, Queensbury, NY) is commonly used to perform IRE~     procedures in pancreatic cancer patients and is commercially available since 2009 and got~     Food and Drug Administration (FDA) 510K clearance for soft tissue ablation in October 2011~     in the United States.~      C. Quality of life and nutritional status/long term outcomes Given the overall poor~     long-term outcomes of patients with pancreatic cancer, health-related quality of life~     (HRQoL) measures are of utmost importance when treatment recommendations are discussed with~     patients. This is especially true for patients with more advanced staged disease where~     definitive surgical resection with curative intent is not possible. However, HRQoL reports~     for patients with locally advanced pancreatic cancer undergoing IRE are very limited. To the~     best of the investigators' knowledge, no other specific investigations exist that assessed~     HRQoL measures for patients undergoing IRE for locally advanced pancreatic cancer, no~     specific assessment exists that focuses on nutritional status for this patient group. In~     addition, impact on local and distant recurrence as well as cancer-specific and overall~     survival are still ill-defined and further information is needed.~   "
10026|NCT02926027|"~     Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated~     Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of~     low attenuation plaque under influence of Vascepa as compared to placebo.~   "
10027|NCT02926014|"~     The aim of this research was to evaluate the lingual tonsil hypertrophy (LTH) grading of~     patients with dysphagia using videolaryngoscopy and determine the relation of LTH grades to~     sociodemographic factors and clinical symptoms.~   "
10028|NCT02926001|"~     The purpose of this study is to evaluate formally the short term impacts of the tax policy~     applied to Sugar-Sweetened Beverages (SSBs) in Chile. The Impuesto Adicional a las Bebidas~     Analcohólicas (IABA, or additional tax on soft drinks) in Chile was enacted in October~     2014, affecting any non-alcoholic beverages to which colorants, flavourings or sweeteners~     have been added. For beverages above an added sugar concentration of at least 6.25 grams per~     100ml (or equivalent proportion), the tax was increased from 13% to 18%, while for those~     below this threshold the tax was decreased to 10%, producing an 8% tax difference between~     these beverage groups. This impact evaluation analysis of the Chilean sugar-sweetened~     beverage (SSB) tax will estimate the impact of increasing the tax as well as decreasing the~     tax on soft drinks. The study will use household level grocery purchasing data for Chile.~     The purchasing records are available from October 2011 to September 2015 (three years~     before; and one year after the implementation of the tax in October 2014). The investigators~     will use a series of quasi-experimental approaches to evaluate the causal impact of the SSB~     tax policy on consumers' behaviour as well as on industry responses in the form of pricing~     and price promotion decisions.~   "
10029|NCT02925988|"~     Over the past decade, technical advances have improved the efficiency of continuous EEG~     recording and remote review, leading to a steep increase in the number of continuous EEGs~     performed, and to an emerging change in what is considered the standard of care with regards~     to brain monitoring. Critically ill patients are at high risk for CNS insults, which can~     result in permanent neurologic disability if untreated. Non-convulsive status epilepticus~     and other secondary brain injuries are often unrecognized without continuous EEG monitoring.~     There is increasing evidence that continuous EEG monitoring facilitates early identification~     and management of changes in brain function, and a recent consensus statement concludes that~     each center should provide critical care continuous EEG at the highest level that local~     resources allow. Neonatal neuro-intensive care is a rapidly developing field with a focus~     on monitoring of the developing brain. Without continuous EEG monitoring, neonates with~     paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for~     many months, with inherent risks of side effects. Because paroxysmal events in neonates may~     or may not represent seizures, and electrographic seizures may have no discernable clinical~     correlate, this approach fails to adequately diagnose seizures and exposes neonates to~     possible harm, either by medication overuse for paroxysmal events that have no~     electrographic correlate, or by under-treatment of seizures without clinical manifestations.~     Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring~     method, using fewer numbers of electrodes and usually being interpreted by a neonatologist~     or trainee. This model has been implemented at the investigators NICU. However, a recent~     systematic review came to the conclusion that amplitude-integrated EEG has relatively low~     and variable sensitivity and specificity, and therefore should not be the mainstay for~     diagnosis and management of neonatal seizures. Continuous video EEG monitoring is~     recommended as the gold standard for critically ill neonates, but is a very expensive and~     resource-intense method. An approach combining both techniques in a standardized algorithm~     may provide improved patient care in a resource-restricted environment. The investigators~     are planning to test this hypothesis in a pilot project.~   "
10030|NCT02925975|"~     The aim of this study is to investigate the possibilities of early and precise management to~     decrease portal vein pressure in cirrhotic patients, guided by a non-invasive~     3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to~     determine the normal range of pressure density in different sites of HPS. Cirrhotic patients~     without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual~     portal vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG~     groups are followed-up and treated according to Baveno V consensus in portal hypertension.~     Patients in vPVPG-monitored groups are followed-up by anatomic computed tomographic~     angiography (CTA) and Doppler ultrasound every six months. Once vPVPG is above 12mmHg,~     participants will receive carvedilol treatment. All cirrhotic patients are followed-up with~     the incidence of portal hypertension-related complications, mortality rate and life quality~     assessment.~   "
10065|NCT02925507|"~     It is the purpose of this study to determine if a commercially available electronic~     stethoscope synchronized with an smart phone or iPad application can be used as an accurate~     and objective screening tool for measuring dysphagia. The investigators plan to do so in two~     phases; in Phase I the investigators will recruit normal subjects to establish normal~     swallowing patterns, as well as optimal sensor placement; and in Phase II the investigators~     will compare the recordings obtained by the electronic stethoscope with those obtained using~     videofluoroscopy.~   "
10031|NCT02925962|"~     The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in~     primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care~     or one of two intervention arms. The first intervention will evaluate the efficacy of an~     automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker~     test ordering, guideline implementation and BP management, compared with usual care, among~     patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention~     goes a step further, and it will evaluate whether a CDSS plus a pharmacist-led CKD~     management program (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity~     knowledge among the patients with newly confirmed higher-risk CKD (eGFRcreat-cys (<45) or~     eGFR (45-59) + ACR ≥30), compared with CDSS alone. The primary clinical outcome is BP level,~     with secondary outcomes related to processes of care and patient knowledge.~   "
10032|NCT02925949|"~     This is a randomized controlled trial of a new behavioral intervention designed to improve~     engagement in HIV care for same-sex male couples. Investigators will compare the HIV viral~     load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or~     to an individual adherence intervention (LifeSteps).~   "
10033|NCT02925936|"~     Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the~     position of the anode and cathode.~   "
10034|NCT02925923|"~     The purpose of this study is to compare the inhibition of platelet aggregation (i)~     ticagrelor and bivalirudin/heparin versus (ii) clopidogrel, eptifibatide and heparin in~     patients with unstable angina undergoing coronary intervention.~   "
10035|NCT02925910|"~     Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a~     regular one. One group will start with the softwheelsl and then change to the regular, and~     the other will start with the regular and then change to the softwheel.~   "
10036|NCT02925897|"~     The prevalence of people living with problems due to a long-term condition (LTC) such as~     heart disease, diabetes or arthritis in England exceeds 15 million, and the number of those~     with more than one LTC continues to grow (LTCs). This population consumes a large proportion~     of health service resources. Advancing age and LTCs increase the likelihood of becoming~     housebound, this has a detrimental effect on health and quality of life. Health policy~     advocates a health service model of empowerment and self-care. People who live with LTCs are~     often very knowledgeable about how to look after their health but find it difficult to~     adjust their.~      Motivational techniques have been demonstrated to facilitate behaviour change through~     changing the style of communication from directive to collaborative. The use of~     patient-centred conversational style of communication has been shown to elicit more~     willingness to change than professional-led directive consultations. Community nurses are in~     a unique position to influence housebound patients to play a greater part in caring for~     themselves, preventing complications in their long-term conditions and further ill health.~      This study intends to test the feasibility and acceptability of training community nurses in~     Understanding Behaviour Change, a communication technique which uses motivational~     interviewing to guide patients to change their behaviour. The opportunistic use of~     motivational techniques to create participatory relationships between patients, community~     nurses potentially represents an effective intervention to enable patients with LTCs to~     optimise the way they care for themselves.~      Motivational interviewing techniques have been widely demonstrated to bring about behaviour~     change but have not been studied in the context of changing the style of communication~     between housebound patients and the professionals caring for them.~   "
10037|NCT02925884|"~     The proposed study aims to test if Gunnar computer glasses provide any advantages, in~     comparison to no glasses, on the following aspects in computer-related office work:~        -  Any enhancement on visual performance of basic visual function, including visual~          acuity, contrast sensitivity, color discrimination, etc.~        -  Any enhancement on visual performance of typical office work, including reading,~          word-spelling check, number searching, or target identification.~        -  Any benefit in objective viewing comfort measured with viewing distance, blink~          frequency, post-viewing pupil size.~        -  Any benefit in subjective viewing comfort reflected on the questionnaire of viewing~          symptom survey.~        -  Any benefit in viewing comfort and visual performance with increased environmental~          ventilation or under strong glare.~        -  Any benefit in life quality from daily wearing (e.g., better comfort or sleep quality).~   "
10038|NCT02925871|"~     There is strong evidence that early supported discharge and continued rehabilitation at home~     (ESD) delivered by an interdisciplinary team reduces deaths or dependency in activities in~     daily living after stroke. Despite recommendations in national guidelines ESD is only~     implemented in few places in Sweden. There are interdisciplinary teams that supply~     rehabilitation in the home but the coordinated transition is lacking. Such rehabilitation is~     not evidence based. The key components of a coordinated transition to achieve the benefits~     of ESD are not known. The aim is to design, implement and evaluate new person-centred~     transitions between stroke units and the home to achieve full ESD. The development of~     person-centred transition will be performed together by people with stroke, significant~     others, stroke unit staff and interdisciplinary teams.~      Phase 1, a prospective observational study of current transitions from stroke units to~     rehabilitation in the home without coordination. The aim is to identify factors that are~     facilitators or barriers to transitions, patient and caregiver outcomes, use of health care~     during the first year after stroke. In phase 2, a co-design process of new person-centred~     transitions will be carried out by people with stroke, significant others, stroke unit staff~     and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions~     will be implemented to form a full ESD service and evaluated in a cluster randomised~     controlled trial.~   "
10039|NCT02925858|"~     Randomized, controlled trial evaluating the effect of an intraoperative infusion of~     intravenous ketamine and lidocaine on the quantity of opioid consumed postoperatively in~     cardiac surgery patients receiving a median sternotomy.~   "
10040|NCT02925845|"~     -  Objective: To analyze the effect of neuromuscular electrostimulation in the maturation~          of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease~          (CKD) stage 5-5D~        -  Design: Clinical Trial with medical devices, 18-month, single-center, within the~          hospital setting.~        -  Disease or disorder study: vascular Access maturation.~        -  Population: Patients with CKD stage 5-5D at the research center.~        -  Project duration: 78 weeks~        -  Methodology:~        -  Patients with CKD stages 5-5D that has undergone a native AV in service stations to~          give their informed consent and meeting the inclusion criteria will be included.~        -  At baseline two study groups were established:~             -  Group 1: neuromuscular electrostimulation~             -  Group 2: isometric exercises~   "
10041|NCT02925832|"~     Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract~     surgeries by phacoemulsification. In this study the investigators intend to compare~     ropivacaine and bupivacaine in various parameters during phacoemulsification.~   "
10042|NCT02925819|"~     The objective of this study is to collect in a prospective registry all cases of French~     patients undergoing an assessment for percutaneous treatment of mitral valve disease on a~     native valve or due to deterioration after surgical valve repair or replacement. In these~     patients, valvular surgery should be considered contra-indicated or at prohibitive risk.~     This registry will evaluate the morbidity and mortality up to 24 months for those patients~     with severe mitral valve disease who are not included in a clinical trial. The association~     of demographic, clinical, laboratory, echocardiographic variables and treatment options with~     morbidity and mortality will be evaluated by univariate and multivariate analyses.~   "
10043|NCT02925806|"~     A drug utilization study will be performed to describe trends in the number of prescriptions~     and patients for class REMS ER/LA opioids and comparator products.~   "
10044|NCT02925793|"~     The purpose of this randomized, double blind, placebo controlled, parallel group study is to~     compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle~     cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis.~   "
10045|NCT02925780|"~     Clinical trial to investigate the clinical efficiency of resin infiltration technique for~     the improvement of dental fluorosis.~   "
10046|NCT02925767|"~     A randomized controlled non-inferiority trial based on split-body was planned to compare the~     efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.~   "
10047|NCT02925754|"~     Pain catastrophizing is conceptualized as a negative cognitive-affective response to~     anticipated or actual pain and has been associated with a number of important pain-related~     outcomes.~      The aims of this study are~        1. To describe the characteristics of the patients and determinants of catastrophizing in~          chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital~        2. To describe the impact of the catastrophizing on the level of insomnia and the drugs~          consumption in chronic painful patients hospitalized in rheumatology in the Nîmes~          University Hospital~   "
10048|NCT02925741|"~     This study will use a traditional cluster randomized crossover design with patients in five~     medical intensive care units at the Cleveland Clinic to evaluate the efficacy of silk-like~     bed sheets and underpads for prevention of Unit-Acquired Pressure Ulcers (UAPU). Adult~     hospitalized patients in beds with standard bed linens versus those with silk-like linens~     will be compared for 1) rate of development of UAPU, 2) time to develop the first UAPU, and~     the maximum severity of any UAPU that develop. Bed linens will be changed per unit protocol.~     Patient characteristics will be summarized using frequencies and percentages for categorical~     factors and means, standard deviations, percentiles and median and range for continuous~     measures. For the primary outcome of unit-acquired pressure ulcer rate, generalized linear~     mixed models, assuming a Poisson distribution for the outcome, and unit length of stay as an~     offset will be used. For the time to event analysis, frailty models will be used to assess~     whether time to first pressure ulcer differs between treatment types. Generalized linear~     mixed models will be used for other secondary endpoints, including maximum severity of~     observed pressure ulcers~   "
10049|NCT02925728|"~     The undernourishment and the prevention of its risk at the elderly person in seniors's~     resident represent a major issue in public health. The diagnosis of undernourishment and its~     risk are systematically recommended in these structures where the nutrition of these people~     is a problem because often inappropriate for their capacities of prehension and consequently~     for their nutritional needs. One of the solutions to remedy can be found in the ~     finger-food .~      The study FIFO (Finger-Food) suggests verifying the hypothesis which the finger-food would~     allow to increase the nutritional intake of the resident who have disorders of the~     prehension and\or requiring a nutritional stimulation and\or require an help to the~     preparation of the meal.~   "
10050|NCT02925715|"~     Comparison of two techniques of central venous cannulation of subclavian vein using~     ultrasound was performed. ultrasound guided central venous cannulation is the standard~     practice today but its use in subclavian vein is technically challenging and not much~     literature is available. In this study 96 Patients were randomized into one of the groups~     and compared for various outcomes. The primary outcome studied was the time taken for~     procedure. Secondary objectives included comparison of total access time using both the~     techniques,comparison of first attempt success rate, comparison of the quality of needle~     visualization and the comparison of immediate (mechanical) and delayed complication rates.~   "
10051|NCT02925702|"~     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer~     Treated With Radium 223~   "
10052|NCT02925676|"~     To evaluate the technical performance of the hyposafe H02 during everyday activities and~     during insulin-induced hypoglycaemia, in addition to safety issues associated with the~     implantation and use of the hyposafe H02 in subjects with type 1 diabetes.~   "
10053|NCT02925663|"~     The purpose of this study is to establish the feasibility, accessibility, acceptability, and~     preliminary efficacy of an individually-tailored intervention to improve EF in adolescents~     with epilepsy (EFI-E).~   "
10054|NCT02925650|"~     This study evaluates the safety and pharmacological effects of 3 different doses of~     Posiphen® when compared to a placebo, in adult male and female patients with early onset~     Alzheimer's disease (AD).~   "
10055|NCT02925637|"~     To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT)~     in occupational therapy for people after mild to moderate stroke.~   "
10066|NCT02925494|"~     This is an extension study for women who have already received six months of treatment in~     the phase III clinical trial M12-815 or M12-817, and will evaluate the long-term efficacy~     and safety of elagolix administered alone and in combination with estradiol/norethindrone~     acetate for an additional six months in the treatment of heavy menstrual bleeding associated~     with uterine fibroids.~   "
10108|NCT02924948|"~     Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of~     pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had~     significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon~     inflation while EUS insertion could result in decreased throat damage and pain, there is no~     data to back up. We designed a single center randomized pilot study to compare throat pain~     caused by EUS insertion with conventional vs balloon inflation method.~   "
10056|NCT02925624|"~     Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial~     Fibrillation ('CLOSE to CURE' study)~      Design: This is a prospective, observational, single-center, unblinded, clinical 3-year~     study.~      Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new~     approach to obtain single-procedure durable PVI, has been shown to virtually eliminate~     recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring.~      Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after~     'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using~     continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and~     electrical properties of the atria or procedural characteristics that predict 1-year and~     3-year outcome.~      Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study.~      Clinical Sites: 1 site.~      Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are~     planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask~     the patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder~     (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic~     echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic~     drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012~     European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal~     2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European~     cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of~     atrial fibrillation (Calkins et al, Heart Rhythm 2012).~   "
10057|NCT02925611|"~     Postoperative delirium (POD) is a known complication of inhalational agents used to~     anaesthetise patients for surgery with potential long term implications.The incidence of~     postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to~     compare the occurrence of postoperative delirium with inhalational anaesthetics namely~     isoflurane and desflurane in spine surgery patients.~   "
10058|NCT02925598|"~     The standard procedure used for airway control in general anesthesia for LC (laparoscopic~     cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway~     devices (SADs) used for airway control for certain types of surgeries. The aim of this study~     was to evaluate and compare the performances of new types of SADs with EI regarding their~     insertion times, durations, perioperative complications and effects on hemodynamic~     parameters and peak airway pressures (Paw) in LC as well.~   "
10059|NCT02925585|"~     The investigators will analyze biomechanical transformation of pelvic floor tissues and~     support structures under affected pelvic floor conditions and repaired states after the~     surgery.~   "
10060|NCT02925572|"~     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which~     permits eccentric (ECC) lower limbs contractions at a defined power output. With this type~     of ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for~     the same power output. Consequently, ECC program could be used in chronic disorders with~     limited capacities, such as obesity.~      The investigators hypothesis that an eccentric training program, as it will induce higher~     mechanical constraints, would improve body composition, especially by reducing fat mass.~     This effect could be explained by an increased rest energy expenditure and a better~     improvement in biological parameters (particularly lipid profile and insulin-resistance)~     after ECC training (versus CON training).~      This study aims to compare the modification of fat mass after an ECC program versus a CON~     program at the same VO2.. The secondary goal is to assess the physiological mechanisms~     involved in the modification of body composition.~   "
10061|NCT02925559|"~     Objectives~      Primary objective:~      To access the change from baseline to week 12 in MAGE index of glycemic variability measured~     by CGMS for dapagliflozin versus. gliclazide MR.~      Secondary objectives:~        1. Change from baseline to week 12 in glycated hemoglobin A1c (HbA1c), fasting plasma~          glucose, postprandial glucose and achievement of HbA1c ≤6.5% and <7% at the end of the~          study) for dapagliflozin versus gliclazide MR.~        2. Change from baseline to week 12 in glycemic variability defined by the interquartile~          range (IQR - interval between 25th and 75th percentiles) measured by CGMS for~          dapagliflozin versus gliclazide MR.~        3. Change from baseline to week 12 in glycemic variability measured by the Standard~          Deviation of the mean glycemia (SD) measured by CGMS for dapagliflozin versus~          gliclazide MR.~        4. Change from baseline to week 12 in glycemic variability measured by the Coefficient of~          Variation (CV) measured by CGMS for dapagliflozin versus gliclazide MR.~        5. Change from baseline to week 12 in the time spent on hypoglycemic range (glycemia~          <70mg/dL) measured by CGMS for dapagliflozin versus gliclazide MR.~      Study design This is a single-center, prospective, randomized, open-label, comparative,~     phase IV study to compare the effects of gliclazide MR and dapagliflozin on Glycemic~     Variability in patients with Type 2 Diabetes Mellitus (T2DM). All patients should be~     treatment naïve or receive standard of care therapy for T2DM as well as for co-morbidities~     based on accepted guidelines and local best practices.~      Target patient population Approximately 120 patients with T2DM will be randomized from study~     site. Patients who were treated with metformin only and had inadequate glycemic control at~     the time of enrollment as well as treatment naïve or non-medically treated (e.g., diet)~     patients, will be enrolled and receive either dapagliflozin 10mg qd or comparator gliclazide~     MR 120mg qd in addition to standard of care treatment for T2DM and co-morbidities.~      Investigational product, dosage and mode of administration Dapagliflozin 10mg tablets~     administered orally once daily for 12 weeks.~      Comparator, dosage and mode of administration Gliclazide MR 60mg tablets administered~     orally, 2 tablets once daily for 12 weeks.~      Duration of treatment The treatment with study medication or comparator will have a total~     duration of 15 weeks.~   "
10062|NCT02925546|"~     GSK2798745 is being developed as a novel therapeutic intervention for the treatment of~     pulmonary edema associated with heart failure (HF) and is currently under investigation in~     the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover~     study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg)~     tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed~     for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet~     A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B),~     milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be~     either A/B/C based on interim PK analysis of data from the first three treatment periods.~      Following a 30-day screening period, subjects will be randomized to one of the 6 treatment~     sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three~     4-day treatment periods. For treatment period 4, the best formulation based on the interim~     analysis data from the three treatment periods will be evaluated under fed conditions. Each~     treatment period will be separated by a minimum of 7 (+14)-day washout period. The total~     duration of participation in the study will be approximately 11 weeks including the~     follow-up visit.~   "
10063|NCT02925533|"~     This research study is studying a combination of two experimental drugs as a possible~     treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder~     Cancer that got worse while on treatment with standard therapy.~      The following interventions will be involved in this study:~        -  B-701~        -  Pembrolizumab~   "
10064|NCT02925520|"~     This is an expanded access study to assess the safety profile and changes in serum direct~     bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive~     therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven~     will be infused intravenously through either a central or peripheral catheter in conjunction~     with parenteral nutrition. The same standards of care provided to all patients receiving~     parenteral nutrition solution will be followed.~   "
10974|NCT02913534|"~     The aim is to identify in patients with brain metastases the predictive factors of overall~     survival, survival without local recurrence and survival with progression-free brain~     metastases after complementary whole brain radiotherapy.~   "
10067|NCT02925481|"~     Each year more than 26,000 pregnancies in the United States end in stillbirth (late fetal~     death at >20 weeks of gestation). A 2011 issue of the Lancet, dedicated entirely to~     stillbirth, recognized it as a too-often-ignored public health problem despite occurring~     once in every 160 pregnancies. The death of a baby is highly traumatic and can incite~     negative mental, emotional, and physical health consequences lasting years after the loss.~     Bereaved mothers with stillbirth have a 4-fold higher risk of depression and 6-fold higher~     risk for post-traumatic stress disorder (PTSD). These mental health consequences are likely~     to negatively affect subsequent pregnancies, many of which occur within the first year after~     loss (50-98%).~      Inter-conception care is provided to women of reproductive age between pregnancies; however,~     few interventions focus on PTSD symptomatology and its related comorbidities in bereaved~     mothers. Treatment for bereaved mothers may include psychiatric medication and/or referral~     to support groups. Because bereaved mothers with stillbirth may have additional mental and~     physical health risks, pharmacological interventions are typically a first and sole line of~     treatment and may not sufficiently allay bereaved mothers' emotional distress. Moreover,~     women may be trying to conceive or may have already conceived and report reticence to taking~     medication. Additionally, support groups with little emphasis on coping may not be helpful~     for some grieving mothers.~      Non-pharmacological approaches, such as yoga, may be an alternative option for bereaved~     women with stillbirth. Yoga has been established as an effective, safe, acceptable, and cost~     effective approach to improving mental health in a variety of populations, including~     pregnant and post-partum women. Yoga has also been used as a means to cope with PTSD~     associated with surviving a traumatic event (i.e., interpersonal violence, military~     veterans). We are unaware of any studies that have explored yoga to reduce PTSD in bereaved~     mothers with stillbirth. Furthermore, online streaming yoga (on-demand videos played in the~     home) has recently grown in popularity and may address the unique barriers that women~     experiencing stillbirth may have. To reduce PTSD symptoms and its co-morbid conditions~     (i.e., anxiety and depression) we propose to develop and test the feasibility and~     acceptability of a home-based, online streamed yoga intervention (www.udaya.com) for~     bereaved mothers with stillbirth.~   "
10068|NCT02925468|"~     The correction of a deep overbite is assumed to involve incisor intrusion and the extrusion~     or eruption of premolars and molars. The latter is also assumed to be the major contributor~     for growing patients where the vertical facial growth increase accommodates for the~     additional eruption of posterior teeth with anterior bite plane appliances.~      In this study the nature and rate of adaptation of the occlusal changes following insertion~     of a fixed anterior bite plane for the reduction of a deep overbite in growing patients will~     be investigated.~   "
10069|NCT02925455|"~     This is a pilot randomized controlled trial of an intervention to improve arm function in~     children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants~     will be randomized to either a group treated with neuromuscular electrical stimulation and~     video games or video games alone. Both groups will receive 6 wks of treatment consisting of~     home and lab sessions. Both the experiment group and control group interventions consist of~     therapist-guided sessions in the rehabilitation clinic and self-administered or~     caregiver-assisted sessions at home. While both groups will receive the same task practice~     and video game training, only the experiment group will receive an electrical stimulation~     device to assist with hand opening during practice. Changes in upper extremity motor~     impairment and function will be assessed for each participant at baseline, mid treatment,~     end of treatment and at 3 mo follow-up.~   "
10070|NCT02925442|"~     Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is~     the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard~     genicular radiofrequency ablation (t-RFA) has been effective pain management for~     non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency~     ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer~     minimally invasive, non-surgical, non-opioid pain relief options following surgery. The~     study will perform a double-blinded, parallel grouped, placebo-controlled randomized study~     to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA,~     and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered~     preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative~     pain relief.~   "
10071|NCT02925429|"~     PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal~     period with the primary scientific objective of determining whether food insecurity was an~     independent risk factor for poor maternal nutritional or psychosocial outcomes or for~     sub-optimal infant feeding practices.~   "
10072|NCT02925416|"~     The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV~     infusions of oritavancin when administered one week apart.~   "
10073|NCT02925403|"~     This is a study in which healthy adult volunteers will be given either an experimental~     Malaria vaccine or a saline control vaccine.~      Each volunteer will receive three vaccinations in total. Volunteers will be randomly~     allocated to one of three groups:~      Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will~     receive a high dose of the Malaria vaccine on days 0, 28, and 56. Group 3 will receive a~     saline solution on days 0, 28, and 56.~   "
10074|NCT02925390|"~     This study involves research, and the purpose of this study is to evaluate live birth rates~     among couples who are treated by Natural procreative technology, (NPT) for infertility and~     miscarriage.~      Comparisons will be made to those declining NPT treatment, waiting for NPT treatment,~     receiving other treatment, or stopping treatment. The investigator seeks to document~     specific pregnancy rates for different factors such as age and type of infertility~     diagnosis. Investigators will also assess characteristics of environmental exposures that~     may be associated with infertility. Couples will be followed for up to three years,~     regardless of when they begin NPT treatment, or whether they continue treatment. Data from~     all couples will be useful for this study, regardless of their individual circumstances or~     actual treatment.~   "
10075|NCT02925377|"~     Female handball athletes are at a particular risk of sustaining lower extremity injuries.~     The study examines time-dependent adaptations of static and dynamic balance as potential~     injury risk factors to a specific warm-up program focusing on neuromuscular control.~   "
10085|NCT02925247|"~     Direct oral anticoagulants (DOAC), an inhibitor of factor IIa (dabigatran) or factor Xa~     inhibitors (rivaroxaban, apixaban) are an alternative to treatment with warfarin in patients~     with atrial fibrillation (AF) non-valvular .~      These molecules have demonstrated non-inferiority compared to warfarin standard treatment~     for the prevention of thromboembolic events in patients with non-valvular AF at high risk~     thomboembolique (Score CHA2DS2-VASc ≥1). These molecules have a constant biological~     effectiveness does not require laboratory monitoring in clinical practice, unlike AVK whose~     use requires, because of their variability action intra- and inter-individual, a constant~     dose adjustment based on 'Nationalized Index Ratio (INR).~      The objective of this study is to evaluate the interest of specific dosage of anti-activated~     factor X activity (Xa) in the identification of non-observing treating patients with Factor~     Xa inhibitor in patients with non-FA valvular~   "
10076|NCT02925364|"~     The current study is an amendment to a previously approved blinded randomized controlled~     trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is~     performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes)~     and examines the incidence of chronic post-sternotomy pain 6 months following surgery.~      Patients enrolled in the parent study will be identified at the 6 month follow-up and~     recruited in terms of whether they report chest pain. A total of 30 participants will be~     recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional~     MRI will be done on the brain stem and spinal cord and anatomical MRI images will be~     collected for specific chest and neck structures. This will indicate whether there are~     long-term differences in pain processing and/or physical damage to neck and chest structures~     in those with and without chronic pain 6 months following coronary artery bypass graft~     surgery. All functional and anatomical MRI images will be reviewed and interpreted with~     study personnel blinded to whether the patient is reporting pain or no pain at their 6 month~     follow-up interview.~   "
10077|NCT02925351|"~     This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography~     (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory~     diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by~     inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to~     measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan~     may help to determine how fluorine F 18 clofarabine is distributed throughout the body.~   "
10078|NCT02925338|"~     National, prospective, multicentre observational study designed for eligible patients~     treated with Inflectra.~      Its objectives are to describe under real conditions of use, the profile of patients treated~     with Inflectra and the response to treatment.~   "
10079|NCT02925325|"~     Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of~     MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at~     the psychiatric clinic, have become a growing problem. Its presence is associated with a~     high probability of relapse / recurrence and disability, as determined by decreased~     performance and low quality of life. Their neglect has generated an increase in clinical and~     socioeconomic costs, alerting the need for research to provide treatment strategies. The~     application of different types of psychotherapy has been successful in abating SRD. The~     present study aims to evaluate the clinical changes related to the application of music~     therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms~     trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals,~     and is defined as the clinical use of musical evidence-based interventions within a~     therapeutic relationship. MT treatment group will design an application schema of 8 sessions~     (2 hrs. Each) over a period of two months (one session per week). The control group will~     receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric~     treatment by the physician in the INPRF, with the same duration. The evaluation will be~     conducted with clinimetric testing at baseline, at the end of the track and after three~     months of treatment. This study seeks to identify the presence of SRD in a Mexican sample~     and explore a treatment designed for that purpose, also, show that the MT is a~     cost-effective implementation can become a new clinical option to extend the possibilities~     of assistance and deepen the investigation of this problem.~   "
10080|NCT02925312|"~     The MedStar Diabetes Institute (MDI), in partnership with key MedStar Health system diabetes~     stakeholders, seeks to implement an evidence-based innovative integrated care pathway for~     MedStar patients with uncontrolled diabetes which will demonstrate improvement in diabetes~     care outcomes.~   "
10081|NCT02925299|"~     The main study objective is to determine whether 24/7 automated closed-loop glucose control~     combined with low glucose feature will improve glucose control as measured by HbA1c.~      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel~     group design study, involving a 12 month period of home study during which day and night~     glucose levels will be controlled either by a closed-loop system combined with low glucose~     feature (intervention group) or by insulin pump therapy alone (control group).~      It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with~     type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the~     investigation centres. Participants will all be on subcutaneous insulin pump therapy.~      Subjects in the intervention group will have proven competencies both in the use of the~     study insulin pump and the study continuous glucose monitoring (CGM) device, and will~     receive appropriate training in the safe use of closed-loop insulin delivery system and low~     glucose feature. All subjects will have regular contact with the study team during the home~     study phase including 24/7 telephone support. The primary outcome is between group~     differences in HbA1c levels at 12 months post study arm initiation. Secondary outcomes are~     the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with~     glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.~     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and~     diabetic ketoacidosis (DKA).~   "
10082|NCT02925286|"~     The purpose of this study is to determine the effects of a workplace prevention program~     targeting problematic gambling.~   "
10083|NCT02925273|"~     The goal of this project is to determine the optimal technique to elicit the grasping~     response in patients with dementia or suspected frontal lobe dysfunction. The proposed study~     is to perform two techniques to elicit grasp response in patients with dementia or suspected~     frontal lobe dysfunction and observe the presence or absence of the response and prominence~     of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians~     in refining their clinical techniques to be more sensitive for diagnosing frontal lobe~     dysfunctions.~   "
10084|NCT02925260|"~     A study to investigate the prevalence of pelvic collections in a representative sample of~     participants with normally functioning ileal pouches. It also aims to establish the~     feasibility and reporting variables for dynamic MRI enemas in ileal pouches and defaecating~     enema pouchography.~   "
10095|NCT02925117|"~     This is a 40-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled~     multicenter study to evaluate the safety and efficacy of ABT-494 in adult participants with~     moderate to severe atopic dermatitis. The participants will be randomized in a 1:1:1:1 ratio~     to one of four treatment groups.~   "
10086|NCT02925234|"~     This is a prospective, non-randomized clinical trial that aims to describe the efficacy and~     toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of~     patients with advanced cancer with a potentially actionable variant as revealed by a genomic~     or protein expression test. The study also aims to simplify patient access to approved~     targeted therapies that are contributed to the program by collaborating pharmaceutical~     companies and to perform next generation sequencing on tumor biopsies for biomarker~     analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell~     non-Hodgkin lymphoma for which standard treatment options are no longer available and~     acceptable performance status and organ function. A genomic or protein expression test must~     have been performed on the tumor and the results must identify at least one potentially~     actionable molecular variant as defined in the protocol. Results from the molecular~     profiling test will be used to determine an appropriate drug(s) from among those available~     in the protocol. The choice of drug will be supported by a list of potential profiles, a~     molecular tumor board, a knowledge library and by study coordinators for review and approval~     of the match. The protocol-specified treatment will be administered to the patient once any~     drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is~     performed for future genetic studies. All patients who receive treatment with a drug~     available in the protocol will be followed for standard efficacy outcomes including tumor~     response, progression-free and overall survival as well as duration of treatment. In~     addition, treatment related toxicity will be evaluated.~   "
10087|NCT02925221|"~     This study is part of the Health Canada approval requirement for tolvaptan and is an~     observational, non-interventional study (NIS) describing the impact of tolvaptan on~     ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO)~     Questionnaires. The study is also describing the time to renal replacement therapy (RRT),~     such as dialysis and transplantation, and the long-term mortality rate and causes (i.e.~     renal and hepatic), in ADPKD patients treated with tolvatan (JINARC™)~   "
10088|NCT02925208|"~     Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant.~     Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess~     is important to safely perform the posterior tympanotomy. Anatomical variation of facial~     nerve such as lateral or anterior position of vertical segment of facial nerve, will render~     this approach challenging. In this research, investigators proposed a Radiological~     Classification system of the position of vertical segment of facial nerve in relation to the~     lateral semicircular canal to predict difficult cases with narrow facial recess.~   "
10089|NCT02925195|"~     The goal of this clinical trial is to determine individual-level genetic and metabolic~     characteristics that modify the response to cholecalciferol treatment.~      This study is double blind, parallel design, randomized clinical trial that will assess~     genetic and metabolic characteristics that modify the response to cholecalciferol treatment.~     . Eligible participants will be randomly assigned to receive cholecalciferol treatment~     (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for~     a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this~     study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that~     modify the biologic response to vitamin D3 treatment, assessed by changes in serum~     concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.~   "
10090|NCT02925182|"~     The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in~     reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were~     included to the study. For each patient, ulceration were randomly assigned to the test or~     the control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact~     mode. In the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain~     was evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a~     clinician.~   "
10091|NCT02925169|"~     Cricoid is considered the narrowest part with the shape of airway defined as elliptical with~     the subglottis as the narrowest region.~      This study using imaging modality (2D CT images) is done to determine any differences in~     airway shape between infants and children, and to evaluate the dimensional transition~     between the subglottic area and the cricoid ring.~   "
10092|NCT02925156|"~     This project examines whether individuals' amount of activity energy expenditure (AEE) is~     related to adiposity and adiposity/diabetes-related hormones in a diverse sample of 2500,~     and to test the ecological hypothesis that a decline in levels of AEE is an important cause~     of the increases in obesity that are currently taking place in many societies.~      One goal is to use doubly labeled water and/or accelerometers to objectively measure~     activity energy expenditure in community samples from five adult populations across the~     spectrum of obesity risk. From each site, (i.e., Ghana, South Africa, Seychelles, Jamaica,~     and the US), 500 black adults will be recruited. Among all participants, AEE will be~     measured using accelerometers and in a subset of 75 per site, AEE will also be measured by~     doubly labeled water.~      The doubly labeled water sample will be used to confirm site-specific concordance with the~     accelerometer measurements and to estimate population mean levels of AEE. Additionally, body~     composition, dietary intake, fasting glucose, insulin, adiponectin, leptin and ghrelin will~     be measured. The relationships between calories expended in activity and body composition,~     dietary intake, glucose, hormones and adipocytokines, both within and between each~     population using doubly labeled water and accelerometers will be examined. In this~     longitudinal study, weight will be measured at 12 and 24-months, and AEE by accelerometer~     will be assessed at enrollment and again at 2-years of follow-up; associations between~     change in AEE and change in weight will be estimated.~      The central purpose of this project is to test whether AEE or change in AEE can be~     identified as a contributory mechanism to population-wide weight gain and, if so, to~     quantify its importance. In addition, we seek to understand the interrelationships between~     the adipocytokines and the hormones ghrelin and insulin as well as AEE in the regulation of~     body weight across the continuum of body mass indices (BMI) represented by these five~     populations.~   "
10093|NCT02925143|"~     To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of~     application of objective neuromuscular monitoring for assessment of depth of neuromuscular~     blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular~     blockade after anesthesia.~      We will collect data prospectively from 6 Danish anaesthesia departments from the time of~     intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline~     data is obtained from another study based on the same data extraction procedure~     (NCT02914119).~   "
10094|NCT02925130|"~     Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and~     chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise~     and muscle performances. The underlying mechanisms are however unclear. Some data suggest~     that Salbutamol may have some effects on the central nervous system which may explain the~     improved exercise and neuromuscular performances. The present study aims to assess the~     effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using~     neurostimulation techniques and magnetic resonance imaging.~   "
10097|NCT02925091|"~     Helicobacter pylori infects ~ 50% of the world's population and a quarter of the European~     population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers~     and gastritis. Chronic infection with H. pylori is a risk factor for the development of~     stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of~     success for an antimicrobial eradication therapy is drastically reduced by the significant~     increase in antibiotic resistance in Austrian H. pylori isolates. The currently available~     data were obtained however from narrowly defined geographical regions and the clinical~     routine without information on patient selection. We suspect a considerable geographical~     variability of resistance patterns and a clinical bias for a preferential investigation of~     patients with unsuccessful, empirical eradication therapy. The objective of the proposed~     study is therefore an Austria-wide collection of data on H. pylori resistance in a~     prospective clinical study. The data thus collected will enable a significant improvement in~     current treatment recommendations.~   "
10098|NCT02925078|"~     The primary objective of this study is to compare the amount of implant marginal bone loss~     radiographically and probing depth in between thin and thick mucosa group that will receive~     a machined collar implant.~      Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant~     with smooth collar.~   "
10099|NCT02925065|"~     This controlled prospective cohort study is designed to assess the feasibility and effect of~     bi-weekly non-traditional guitar classes on PD patient's self-reported and measurable~     outcomes including upper extremity function, motor findings, quality of life, mood, and~     cognitive findings. Prior to conducting a larger study, this study seeks to assess the~     possibility that participation in an instrumental performance activity in a group setting~     may improve outcomes in PD patients. Twelve patients with PD will be recruited to~     participate in the guitar class group (intervention) in addition to usual treatment, while~     another group of 12 patients with PD will be recruited to the control group to receive only~     their usual treatment.~   "
10100|NCT02925052|"~     A randomized controlled prospective study of orogastric tube placement with the Gastric Tube~     Guide vs conventional placement.~   "
10101|NCT02925039|"~     The sit-to-stand (STS) movement is a key functional movement critical to independent living.~     This movement is physically demanding to conduct, especially in older adults, and in the~     presence of physical impairments associated with a range of conditions, such as stroke,~     osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this~     movement increases the risk of falls, dependency and increased support for personal care and~     rehabilitation. Restoring independence in this movement is, therefore, considered a priority~     for physical rehabilitation.~      Sit-to-stand capacity can be regained through participating in rehabilitation exercises.~     Providing feedback on performance of this movement could enhance the training. Thus, it is~     an essential aspect of physical therapy. Healthcare providers are required to meet the needs~     of an increasingly frail population as well as meeting national, evidence-based, guidelines~     for improving outcomes in conditions such as stroke which includes an increase in the~     practice repetition of functional movements. Reliance on rehabilitation staff to provide~     practice, however, places a limit on practice volume, potentially restricting outcomes.~     Using technology to enhance safe, repetitive practice of this movement with minimal~     supervision from skilled professionals would be beneficial to patients and rehabilitation~     services.~      The primary aim of this study is to test the acceptability and feasibility of a STS training~     system that enhances movement feedback to patients undergoing rehabilitation. A secondary~     aim is to gather data on the effectiveness of the system compared to conventional~     rehabilitation. This information will inform a statistically powered phase 2 trial.~   "
10102|NCT02925026|"~     Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme~     supplementation in improving environmental enteric dysfunction in Malawian children~   "
10103|NCT02925013|"~     This study aims to investigate the omega 3 lipid profile in pregnant women at term and their~     fetuses compared to non pregnant women , in normal western diet adding no supplementation~   "
10104|NCT02925000|"~     This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety,~     Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection~     in Patients with Advanced Malignancy.~   "
10105|NCT02924987|"~     Multicenter randomized trials have demonstrated the safety and efficacy of intravitreal~     anti-vascular endothelial growth factor (anti-VEGF) agents for the treatment of diabetic~     macular edema. The results are generally good in the short term, with approximately 75% of~     patients maintaining or improving vision after initiation of treatment. Despite this~     favorable outcome, the observation of persistent fluid is not infrequent during treatment,~     even in patients undergoing monthly treatment sessions. Persistent fluid was observed on~     optical coherence tomography (OCT) in 70.9% of patients receiving bevacizumab monthly and in~     79% of those receiving bevacizumab as needed at the end of the first year in the Comparison~     of diabetic macular edema. Treatment Trials. It is possible that resolution of this fluid,~     especially when it is centrally located (i.e., foveal), might result in better visual~     outcomes.~      A drug with higher VEGF-binding affinity may help patients with persistent fluid despite~     treatment with bevacizumab. Aflibercept is a new intravitreal VEGF antagonist approved on 28~     November 2014 by the Health Canada for the treatment of diabetic macular edema.~      In contrast to the antibody-based VEGF binding strategy used by bevacizumab, aflibercept~     incorporates the second binding domain of the VEGFR-1 receptor and the third domain of the~     VEGFR-2 receptor. By fusing these extracellular protein sequences to the Fc segment of a~     human IgG backbone, developers have created a chimeric protein with a very high VEGF binding~     affinity. Aflibercept binds all isomers of the VEGF-A family like bevacizumab, but it also~     binds VEGF-B and placental growth factors 1 and 2,1,2 which have been both implicated in the~     pathogenesis of diabetic retinopathy and of age-related macular degeneration. In addition,~     because of the increased trough binding activity and the stronger binding affinity,~     aflibercept should be efficacious in neutralizing VEGF more effectively and for longer~     duration.~   "
10106|NCT02924974|"~     This study will investigate if a single shot of spinal morphine will increase patient~     satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy~   "
10107|NCT02924961|"~     The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA)~     and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant~     design on kinematics and micromotion. During two tasks the kinematics measured with~     fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen~     Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis~     and the bone for the MB and FB Triathlon knee.~   "
10109|NCT02924935|"~     This study evaluates the role of histidine in patients with HARS Syndrome. Children with~     HARS Syndrome will receive oral nutritional supplementation with histidine at a dose which~     will be increased in the event of acute febrile illness. Vision, hearing and plasma~     biomarkers will be monitored throughout the study period.~   "
10110|NCT02924922|"~     Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality~     for small renal masses. In this setting, robot-assisted and conventional laparoscopic~     approaches are gaining more consensus every day. However, until now, no superiority of one~     technique over the other has yet been demonstrated, especially on postoperative function~     recovery.~      This study compares oncological and functional outcomes after laparoscopic partial~     nephrectomy versus robot assisted partial nephrectomy.~   "
10111|NCT02924909|"~     Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in~     a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus~     carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive~     surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and~     14 days after de first cycle to determine the relation between metabolic response and~     survival.~   "
10112|NCT02924896|"~     Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite~     regulation~      Design: A randomized, single blind, cross over design including 4 single study visits~     separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where~     different types of fat will be given.~      Population: 12 healthy males and females aged between 18 and 60 years with body mass index~     (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin~     resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal~     disease, history of diabetes, hypertension or hyperlipidaemia.~      Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake~     like drink containing fat, protein and carbohydrate. A cannula will be inserted for the~     duration of the study day but no blood will be taken. Studies show than during the first~     visit stress response can affect the metabolic response to the study drink resulting in~     inaccurate results.~      Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more~     study visits separated by a week to test the metabolic response to the following fats: palm~     olein, interesterified palm olein and soybean oil in random order. Participants will be~     asked to complete a visual analogue scale questionnaire about their appetite at each time~     point. Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will~     be measured.~   "
10113|NCT02924883|"~     This phase II, double-blind, randomized, placebo-controlled multicenter study will~     investigate the efficacy and safety of trastuzumab emtansine in combination with~     atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or~     metastatic breast cancer who have received prior trastuzumab and taxane based therapy,~     either alone or in combination, and/or who have progressed within 6 months after completing~     adjuvant therapy.~   "
10114|NCT02924870|"~     Main objective: To compare the level of physical activity (PAL) at 12 months in patients~     with moderate to very severe chronic obstructive pulmonary disease (COPD) between those who~     completed a health education program and those who did not.~      Study patients. Subjects older than 35 years; diagnosis of moderate to very severe COPD~     (FEV1 <80% predicted), established at least 3 months; current or former smoker with an~     accumulated consumption >10 packs x year; and hospital admission for COPD exacerbation.~      Design. Randomized, parallel and open-label clinical trial, controlled with conventional~     treatment.~      Intervention: During hospitalization, selected patients will receive conventional treatment.~     At discharge, they will be randomized (1:1) to control group [treatment and follow-up~     according to conventional clinical practice] or intervention group [in addition to~     conventional treatment and follow-up, the patients will be referred to a nursing~     consultation for perform two health education sessions, at 15 and 30 days after hospital~     discharge].~      Measurements. At 15 days and 12 months after discharge, the following determinations will be~     made: anthropometric characteristics; clinical evaluation (smoking history, date of COPD~     diagnosis, comorbidities, current medication; health care utilization; moderate or severe~     COPD exacerbations); questionnaires (mMRC, Charlson, COPD-specific co-morbidity test (COTE),~     COPD Assessment Test (CAT) and LCADL), spirometry and six-minutes walking test; and~     evaluation of daily physical activity using an accelerometer.~   "
10115|NCT02924857|"~     The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study,~     designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in~     superficial femoral or popliteal arteries with the intention of obtaining regulatory~     approval to market this device in the United States~   "
10116|NCT02924844|"~     The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of~     care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost~     expenditure in two French ICUs.~   "
10117|NCT02924831|"~     1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR)~          and its variability (HRV).~        2. To compare the curative effects and the HR/HRV indices between applicationa of~          different acupoints as well as different treatments (acupuncture and moxibustion).~   "
10118|NCT02924818|"~     Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease~     (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are~     characterized by lung inflammation and remodelling. Clinical, functional, microbiological,~     biological, pathological and prognosis features are highly variable and heterogeneous. A~     precise phenotyping is a key-element to better understanding the pathophysiology of these~     chronic inflammatory diseases and to develop innovative treatment strategies.~      The objectives of this prospective study is to analyze the clinical, demographic,~     biological, morphological, pathological, and microbiological characteristics in a cohort of~     patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between~     clinical, demographic, biological, morphological, pathological, and microbiological features~     will be assessed.~      The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the~     RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a~     monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18~     year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD,~     bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed~     consent for inclusion. Exclusion criteria include subjects protected by the law as~     required by the French authorities. Control patients with no respiratory diseases after~     clinical and pulmonary function tests assessment will be also included. The expected number~     of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25;~     controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016)~     to September 2019 (9/30/2019).~      For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at~     inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care~     with no specific therapeutic intervention. For control patients, data will be registered at~     inclusion with no follow-up.~      Data will be registered in a centralized anonymized database. The characteristics of the~     patients will be described as mean and standard deviation for quantitative data and as~     number and percentages for qualitative data. Comparisons and associations between groups and~     variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as~     applicable. A p<0.05 will be considered as significant.~      This study should help to better characterize clinical, demographic, biological,~     morphological, pathological, and microbiological characteristics and phenotypes in chronic~     inflammatory respiratory diseases.~   "
10119|NCT02924805|"~     Comparison of telemedical prehospital emergency care and conventional on-scene physician~     based care of hypertensive emergencies and urgencies. The adherence to current Guidelines~     should be researched.~   "
10121|NCT02924779|"~     This is a small observational study investigating the physical changes that occur to~     epidural catheters after insertion for obstetric anaesthesia. Using the observed physical~     changes as a correlate for the position of the catheter in the patient we will investigate a~     connection between the position and e function during labour. This information may be useful~     in guiding the physicians responses to epidurals that do not provide adequate analgesia to~     aid in deciding on the most appropriate action~   "
10122|NCT02924766|"~     The purpose of this study is to assess the safety and pharmacokinetics of niraparib when~     administered in combination with apalutamide in men with metastatic castration resistant~     prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair~     anomalies.~   "
10123|NCT02924753|"~     This is a study for patients who have been previously treated for B-ALL. The purpose of this~     study is to determine the safety and feasibility of CART-19 cells to the patients with~     relapsed and refractory CD19+ B-ALL.~   "
10124|NCT02924740|"~     Pelvic Floor Muscle Training (PFMT) is the basis of conservative treatment in women with~     SUI. In systematic reviews, PFMT was recommended as a first option for treatment of SUI. The~     aim of PFMT is to improve sphincter activity and increase the support of bladder and~     urethra. Recommendations regarding the prevention and treatment of SUI with PFMT include~     Knack maneuver (the conscious contraction of the pelvic floor before and during the~     abdominal pressure increases); pelvic floor exercises to enhance the structural support and~     endurance of pelvic floor muscles; adding transversus abdominis contraction; and functional~     rehabilitation.It was reported that the progressive overload principle should be considered~     to improve the muscle strength and endurance. According to this principal, resistance~     against to movement, duration and/or frequency should be increased to obtain the optimal~     response. There are a lot of methods to run a muscle or muscle group based on the~     progressive overload principal. These are adding resistance or weight, increasing the~     duration and number of contraction, changing the type of exercise and the range of movement.~     In the literature, it was reported that special vaginal or rectal tools, vaginal cones or~     tampons might be used to establish resistance during the pelvic floor muscle exercises.the~     use of cones in a different way may provide extra benefit for patients: patients can be~     instructed to perform pelvic floor muscle contraction and try to pull the cone or the other~     tools out of the vagina. In this study, investigators preferred to use vaginal tampons since~     pulling the cone out of the vagina cause the elimination of the weight of the cone. Vaginal~     tampons are also sterile, hygienic, and single use. There is no study investigates the~     effects of vaginal tampon exercises in the literature. Therefore, the aim of this study is~     to investigate the effect of the vaginal tampon training adding to PFMT on symptoms of the~     urinary incontinence, the strength and the endurance of pelvic floor muscles and the quality~     of life.~   "
10125|NCT02924727|"~     The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a~     target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg~     twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of~     composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event~     analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary~     congestion, with no known prior history of chronic HF..~   "
10126|NCT02924714|"~     The trial The stop-GIST trial is an Oslo University Hospital sponsored, prospective,~     open-label, 1-group, multicenter phase II trial evaluating discontinuation of imatinib in~     highly selected patients treated with imatinib longer than 5 years for oligo-metastatic GIST~     (≤ 3 metastases) and who have no detectable overt GIST lesions on CT/MRI imaging following~     complete surgical resection (R0/R1-resection) or radiofrequency ablation (RFA) of the~     metastases.~   "
10127|NCT02924701|"~     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by~     destruction of the small intrahepatic bile ducts. sCD163 is a macrophage activation marker~     shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The~     investigators want to investigate whether sCD163 and sMR correlate with disease severity in~     patients with PBC, and whether sCD163 and sMR can predict short term disease progression,~     changes in quality of life and death in these patients.~   "
10128|NCT02924688|"~     A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder~     inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new~     treatment option for the management of asthma by improving lung function, health-related~     quality of life (HRQoL) and symptom control over established combination therapies. This is~     a phase III, multi-centre, active-controlled, double-blind, parallel-group study to compare~     the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This~     study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization,~     Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all~     protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will~     receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA)~     (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice~     a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week~     stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the~     morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the~     pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment~     period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg;~     200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the~     morning. The duration of the treatment period is variable but will be a minimum of 24 weeks~     and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled~     at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52,~     respectively). A follow-up visit will be conducted approximately 7 days after the end of~     treatment period or, if applicable, after the early withdrawal visit. Subjects will be~     provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue~     medication) throughout the study. Approximately 2250 subjects will be randomized, with~     approximately 375 subjects randomized to each of the 6 double-blind treatment arms to ensure~     approximately 337 evaluable subjects per treatment arm. DISKUS and ELLIPTA are registered~     trademarks of GSK groups of companies.~   "
10129|NCT02924675|"~     Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be~     primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of~     referred otalgia involves several non adjacent nerve territories as those of head, neck or~     ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized~     far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.~      Four cranial nerves participate in the sensory innervation of the external ear: the~     trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the~     Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the~     external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the~     Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However,~     there are important interindividual anatomical variations.~      The relationship between referred otalgia and probable nerve damage has been described. In~     he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then~     explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic~     component.~      In the literature, the curative treatment of referred otalgia is the cancer treatment.~     However, the high intensity of referred otalgia leads the patients to a large consumption of~     analgesics in particular of opioids. These latter are particularly adapted for pain~     resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of~     gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent~     voltage channels in the central nervous system. its effectiveness has been demonstrated for~     the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions~     in the bone marrow but also the postoperative pain when the molecule is administered after~     the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two~     or three daily doses.~      The purpose of this study was to evaluate the activity of pregabalin administered orally for~     three weeks after the anesthesia consultation on the intensity of the pain of referred~     otalgia and on its neuropathic component.~   "
10344|NCT02922062|"~     The purpose of this study is to determine the effects of palm oil when consumed as either~     part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular~     health and inflammation. The study will help us better understand how the quality of~     saturated fat and the quantity of carbohydrate interact to impact blood lipids and~     cardiovascular health.~   "
10130|NCT02924662|"~     Studies have reported that the patient's psychological state such as anxiety, depression and~     other emotion affect the therapeutic effect of osteoarthritis, also may be the important~     reason for the poor knee joint osteoarthritis efficacy.~      The aim of this study are firstly to investigate the depression status of patients with~     osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression~     will affect depression status, ultimately, provide reference for clinical.~   "
10131|NCT02924649|"~     Increasing focus on the negative effects of bed rest have become more apparent in the~     intensive care unit within the last decade. A few studies have found an association between~     early rehabilitation starting at the intensive care unit and outcome after discharge from~     rehabilitation. The early mobilization presents with challenges regarding haemodynamic~     stability. The purpose of this randomized controlled trial is to investigate the effect of~     early and intensive mobilization on functional parameters as well as haemodynamic stability.~   "
10132|NCT02924636|"~     The purpose of this study is to assess the efficacy of an electronic-based intervention to~     help pregnant overweight and obese women gain an appropriate amount of weight and improve~     their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a~     composite outcome including instrumental delivery and Caesarean section, as clinically~     relevant outcomes because the mode of delivery is one of the major goals of the obstetrical~     management and is is strongly associated with body mass index and gestational weight gain.~   "
10133|NCT02924623|"~     Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA)~     disease activity, as quantified by the patient's global assessment (PGA) and by the~     evaluator's global assessment (EGA).~      The objectives of this study were:~        1. to explore the extent and reasons for the discordance between patients and physicians~          in their perception of RA disease activity~        2. to determine if this discordance at baseline is associated with RA outcomes at 1 year~          (remission, function and structure) in early arthritis (EA) in daily clinical practice.~             -  Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2~               swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR~               criteria for RA at baseline~      Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed.~     Multivariate linear regression was used to determine the patient and EA features~     independently associated with discordance (calculated as PGA - EGA). Logistic regression was~     used to analyze discordance as│PGA - EGA│≥20.~      Multivariate logistic models were used to determine if discordance at baseline is associated~     with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25)~     and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.~   "
10134|NCT02924597|"~     To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio~     frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with~     robot-assisted laparoscopic partial nephrectomy without hilar clamping.~   "
10135|NCT02924584|"~     Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in~     relatively early stages. Only 700 metastatic breast cancer were registered in Official~     Cancer Registration 2012, while more than11,305 were registered as early breast cancer. With~     broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer~     patients can survive longer and longer. However, there is no prevalence of metastatic breast~     cancer can be available yet. NHIA database coverage is more than 90% population in Taiwan,~     thus it can be an appropriate surrogate of prevalence. In this retrospective database~     analysis, we will explore the real world experience on aromatase inhibitor use for breast~     cancer in Taiwan.~   "
10136|NCT02924571|"~     The aim of this investigation is to compare the use of bone marrow aspirate concentrate~     (BMAC) and allograft versus to recombinant human bone morphogenetic protein-2 (BMP) in~     subjects undergoing elective thoracolumbar spinal fusion with interbody support. The~     investigators will look at the safety and efficacy of these two different surgical methods~     by assessing surgery outcomes and participants' quality of life.~   "
10137|NCT02924558|"~     The goal of this study is to evaluate the effects of replacing some refined starches and~     added sugars with a combination of egg protein and unsaturated fatty acids on markers of~     cardiometabolic health in men and women with hypertriglyceridemia.~   "
10138|NCT02924545|"~     Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic~     fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital~     taking prediction of treatment of osteoporosis as criterion.~   "
10139|NCT02924532|"~     The main objective of this study is to establish an optimal threshold Early parathormon~     (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative~     predictive value of hypoparathyroidism highest possible.~   "
10140|NCT02924519|"~     Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the~     general population and in 21% of the elderly population.~      Of particular interest is prediction of postoperative pain after outpatient arthroscopic~     shoulder surgery since the clinical experience is that surgery does not always provides pain~     relief and the interindividual variation in acute postoperative pain intensity is~     significant. In addition, a Swedish study has shown that shoulder operations are associated~     with longer convalescence than other orthopaedic outpatient surgeries.~   "
10141|NCT02924506|"~     Nowadays, there is no clinical and radiological study comparing two different types of~     mobile implants in patients requiring surgical treatment for symptomatic cervical disc~     disease. Thus, the choice of the ideal implant remains uncertain.~      The goal of this work is to compare the impact of two types of mobile implants in height~     drives, solicitation facets, positioning and collection of prostheses within the~     intervertebral spaces.~   "
10156|NCT02924311|"~     The main objectives of this observational study are to describe outcomes, monitoring and~     treatment patterns of patients with diabetic macular edema in routine clinical practice who~     are either treatment naïve patients or previously treated patients. The total study~     population will be evaluated as well as the two subgroups (previously treated patients and~     treatment naïve patients).~      This study is designated to answer French Health Authority (HAS Haute Autorité de Santé)~     requirements.~   "
10345|NCT02922049|"~     To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness~     analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting~     persistent/recurrent IM, recurrent neoplasia and buried glands.~   "
10142|NCT02924493|"~     Many patients with endometriosis experience extra genital and abdominal symptoms as a major~     part of their problem. This includes gastrointestinal dysfunction with pain, urinary~     symptoms compatible with interstitial cystitis and gastrointestinal symptoms resembling the~     irritable bowel syndrome (IBS). Such problems may be secondary to changes in autonomous~     neuronal structure and function elicited by the endometriotic elements, which may cause a~     visceral syndrome with the above mentioned symptoms.~      The investigators hypothesize that dietary treatment will improve the experience of~     gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related~     irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study~     investigating patients with both endometriosis and IBS, is to test the application of a low~     FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to~     stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot~     study is to investigate the applicability of a placebo diet in patients with endometriosis~     and to investigate the compliance in both intervention group and control group. In addition,~     the aim is to investigate whether the participants find the diet manageable and whether they~     are able to identify the placebo diet.~   "
10143|NCT02924480|"~     Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be~     enrolled into a randomized, double blinded clinical trial to assess if postoperative pain~     and ileus are reduced by perioperative intravenous lidocaine infusion versus placebo. The~     hypothesis is that patients receiving the lidocaine infusion will experience better pain~     control and ileus resolution. It is believed that lidocaine patients will also have less~     opioid requirement, less mortality, a shorter length of stay, less nausea /vomiting, and~     fewer adverse events.~   "
10144|NCT02924467|"~     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,~     only about half of children are vaccinated annually, leading to substantial influenza~     disease in children and spread of disease to adults. A major barrier is that families are~     not reminded about the need for their children to receive influenza vaccination. The~     investigators will evaluate the impact of patient reminder/recall performed by state~     immunization information systems to improve influenza vaccination rates by using three~     clinical trials in two states. The investigators will assess effectiveness and~     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The~     investigators will disseminate the state immunization information system-based~     reminder/recall system to all states for use for seasonal and pandemic influenza~     vaccinations with the goal of lowering influenza morbidity.~   "
10145|NCT02924454|"~     The aim of this study is to investigate whether intravenous lipid emulsion is effective in~     attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking~     agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion~     affects the pharmacokinetic parameters of metoprolol.~   "
10146|NCT02924441|"~     To determine in a randomized trial whether it is possible to decrease the discomfort and~     anxiety of mammography by using the local analgesic lidocaine, or by using calming music in~     patients receiving a mammogram.~   "
10147|NCT02924428|"~     The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using~     the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual~     applicator using two intense pulsed light wavelength bands.~   "
10148|NCT02924415|"~     Bipolar disorder patients frequently presents recurring episodes and often experience~     subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low~     quality of life, relapses of disease and recurring hospitalization. Early diagnosis and~     appropriate intervention may play a role in preventing the neuroprogressive course of~     bipolar illness. The new technologies represent an opportunity to develop psychological~     standardized treatments using internet devices that minimizing the limitations of face to~     face treatments because of its accessibility that allow adjusting to the availability of~     each user. However, although exist many online psychological programs through web and mobile~     devices for bipolar disorder, there is not evidence about their efficacy and effectiveness~     due to the variability in measures and methodology used.~   "
10149|NCT02924402|"~     This study will determine a dose and schedule for XmAb13676 in the treatment of CD20~     expressing hematologic malignancies.~   "
10150|NCT02924389|"~     The purpose of this study is to find out how well the HIV medication dolutegravir gets into~     different parts of the body: including blood plasma, special blood cells, and rectal tissue.~     Specifically, investigators want to compare how fast dolutegravir lowers the HIV viral load~     in these three different sites. In addition, investigators seek to learn if there are any~     differences in how dolutegravir acts in males and females. Results of this study will~     provide more information about HIV medications and their limitations. In the future, this~     could help create better HIV medications that can get into these hard-to-reach places and~     eventually cure HIV infection.~   "
10151|NCT02924376|"~     The purpose of this study is evaluate the efficacy of INCB054828 in subjects with~     advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation~     who have failed at least 1 previous treatment.~   "
10152|NCT02924363|"~     The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to~     define the anatomic and functional remodeling that results from MitraClip implantation. A~     total of sixty (60) patients undergoing MitraClip implantation will be enrolled across~     multiple sites. The severity of mitral regurgitation, cardiac morphology and function will~     be assessed in these patients at BASELINE (within 30 days prior to MitraClip implantation),~     during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the~     CHRONIC REMODELING PHASE (6 months post-implantation).~   "
10153|NCT02924350|"~     This single center study will investigate the efficacy of an experimental stannous fluoride~     containing dentifrice in relieving DH compared with a standard fluoride dentifrice after~     short term use.~   "
10154|NCT02924337|"~     The purpose of this study is to assess the effect of a single therapeutic dose and a single~     supra-therapeutic dose of imeglimin on the QT/QTc interval~   "
10155|NCT02924324|"~     The purpose of this study is to identify whether or not the addition of a numbing medicine~     that is injected directly into the site of the bone marrow procedure can reduce pain and the~     use of opioid pain medication after bone marrow procedures. The addition of this medicine,~     called ropivacaine, is the experimental part of this study. This is the first time~     ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.~   "
10157|NCT02924298|"~     In the past two decades, the prevalence of obesity in the US has increased from 23.2% to~     32.9%. This epidemic is fueling the Chronic Kidney Disease (CKD) epidemic. This likely is~     the major challenge facing the nephrology community in the next decade and beyond. This~     pilot study is designed to test the feasibility of the Sit Less, Interact, Move More (SLIMM)~     intervention and to determine its preliminary impact on light physical activity (PA) levels.~     Increasing light PA may have significant impact on both obesity and slowing the progression~     of CDK.~   "
10158|NCT02924285|"~     For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with~     structural heart disease the current European Guidelines for the management of patients with~     ventricular arrhythmias and the prevention of second cardiac death recommend catheter~     ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized~     data this study investigates the comparison of catheter ablation and antiarrhythmic drug~     therapy for PVC treatment in patients with structural heart disease. Therefore, patients~     will be randomized to one of two treatment strategies: 1) catheter ablation, or 2)~     antiarrhythmic drug therapy (amiodarone, flecainide/propafenone if compatible with~     underlying heart disease).~   "
10159|NCT02924272|"~     The purpose of this study is to provide continued access to ixazomib and evaluation of the~     long-term safety profile of ixazomib.~   "
10160|NCT02924259|"~     The purpose of this study was to examine the effects of a foam rolling intervention on~     pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle~     groups. Through this research we sought to gather data to further develop the methodology~     for future studies of this intervention.~   "
10161|NCT02924246|"~     Rationale: Oral vaccination is known to induce a systemic immune response as well as an~     immune response in mucosal tissues, and can therefore serve as a model to study systemic and~     mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model~     vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have~     been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this~     pilot, in this study oral cholera vaccination will be applied to study the support of~     immunity by raw milk, compared to heat-treated milk. The study design has been optimised~     based on previous results: study duration is extended and sample size is based on relevant~     change and known variation in the primary outcome parameters.~      Infections are an important worldwide cause of death, both in elderly and young children.~     Therefore, support of immunity could help to reduce the incidence of infections. To screen~     the potential of specific foods or food ingredients to support immunity, oral vaccination~     can serve as a model. In a previous study, this model was developed using oral cholera~     vaccination in human adult volunteers. In that study, raw milk was shown to support the~     immune response to vaccination. In this follow-up study, the effect of raw milk will be~     compared with pasteurized and ultra-heat treated (UHT) milk.~      Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the~     immune response as induced by oral cholera vaccination, in comparison to raw milk and to~     regular vaccination.~      Study design: The study is designed as a single-blind randomized controlled trial of 6~     weeks.~      Study population: Healthy subjects of 18-50 years of age.~      Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements~     for production of raw milk, and that has been screened according to the safety criteria for~     raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat~     pasteurized milk.~   "
10162|NCT02924233|"~     This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of~     Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every~     second week.~      The phase 1b (dose-escalation) portion of the trial is expected to begin Q4 2016. Patients~     will be sequentially enrolled to dose-escalation (or de-escalation) cohorts until~     establishment of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of~     Sym004 in combination with nivolumab.~      The phase 2b (dose-expansion) portion of the trial is expected to begin after establishing~     the RP2D.~   "
10163|NCT02924220|"~     Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria~     monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and~     maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%.~     A better knowledge on the factors involved in its occurrence and in clinical manifestations~     is therefore needed to improve outcome.~      A number of frequent acquired risk factors for listeriosis have been identified, such as~     pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no~     genetic study on host susceptibility to listeriosis in humans has been performed so far, in~     the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is~     based on Lm culture from clinical samples. This method lacks sensitivity, and the~     contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated.~      The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is~     the first national case-control prospective study on listeriosis. It is implemented since~     2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each~     patient clinical and biological data and biological samples. Controls with comparable~     background and presentation are also included. 818 cases have been included (427 S, 252 CNS~     and 107 MN) over 3.5 years, along with 456 controls.~      The aim of the study is to identify human genetic susceptibility factors to listeriosis,~     biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help~     improve management of patients with listeriosis.~      Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing;~     biomarkers a identification in serum and plasma of patients and controls by simultaneous~     multi-analyte and metabolomic profiling.~   "
10164|NCT02924207|"~     To determine the impact of an electronic decision support tool on physician decision making~     and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary~     endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of~     therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH~     decision tool will produce greater reduction overall in measurements of hemoglobin A1c in~     patients who participate and follow the PATH decision tool than patients who elect not to~     follow the PATH decision tool. PATH decision tool will provide more cost effective solutions~     for management of diabetic medication than current methods.~   "
10165|NCT02924194|"~     The purpose of this study is to evaluate the safety and effectiveness of deep brain~     stimulation of the nucleus basalis of Meynert (also called the nbM) at improving memory in~     Parkinson's disease patients with mild cognitive impairments and memory difficulties.~     Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS)~     therapy for improvement of their motor symptoms and with evidence of mild cognitive~     impairments and memory difficulties will be enrolled.~   "
10197|NCT02923778|"~     This phase II trial studies the side effects of talimogene laherparepvec and radiation~     therapy and to see how well they work in treating patients with newly diagnosed soft tissue~     sarcoma that can be removed by surgery. Biological therapies, such as talimogene~     laherparepvec, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop cancer cells from growing. Radiation therapy uses~     high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors.~     Giving talimogene laherparepvec and radiation therapy may work better in treating patients~     with soft tissue sarcoma.~   "
10346|NCT02922036|"~     This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal~     trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization~     Therapy.~   "
10166|NCT02924181|"~     Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter~     ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing~     catheter is a new catheter which has valuable tools to monitor and increase the efficacy of~     PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on~     immediate PV isolation and outcome. However, there might be confounding factor as~     inter-individual variation. Therefore, we would like to compare the efficacy of contact~     force-sensing catheter within same patient but different veins.~      In this study, we would like to confirm the efficacy of contact force-sensing catheter on~     immediate PV isolation outcome within same patient. This study randomized the right or left~     PVs whether to use the contact force-sensing function or not. The study design will minimize~     the inter-individual variation on evaluating the efficacy of contact force-sensing catheter~     on immediate PV isolation.~      Also, in patients who had recurred AF or AT, we would like to evaluate the long-term~     efficacy of contact force-sensing catheter on PV isolation.~   "
10167|NCT02924168|"~     This is a double blind randomized clinical trial to evaluate the effect of radial shock~     waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes~     in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and~     will undergo motor, functional and cortical excitability evaluations before and after four~     weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4~     bar of air pressure will be applied to the active group, resulting in an energy flux density~     (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except~     for the fact that no energy flux will be applied.~   "
10168|NCT02924155|"~     This study is a randomized, double-blind, placebo-controlled, single day/multiple day~     dosing, Phase I clinical trial to investigate the systemic exposure, safety and local~     tolerability of SJP002 ophthalmic solution in healthy Korean male volunteers.~   "
10169|NCT02924142|"~     PICOTS:~      P: Kennedy class І patients~      I : Mandibular removable partial denture with OT Cap attachment~      C: Mandibular removable partial denture with gingival approaching clasp assembly~      O: 1ry outcome: Oral Health Related Quality of Life~      2ry outcome: Biting force~      T: 1 Year~      S : Randomized control trial~      Research question:~      In Kennedy class І patients will the removable partial denture with OT Cap attachment~     compared to conventional removable partial denture with clasp assembly results in difference~     in Oral Health Related Quality of Life of Patients?~   "
10170|NCT02924129|"~     The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke~     SCS System with feedback control to treat chronic pain of the trunk and/or limbs.~   "
10171|NCT02924116|"~     The purpose of this study is to determine the effects of the Bioboosti device on sleep for~     patients who have been diagnosed with insomnia.~   "
10172|NCT02924103|"~     A test of a newly designed device (Contamination free bacterial swab). This device can be~     used to introduce a standard bacterial swab into the nose without direct or indirect contact~     with the nasal vestibule.~   "
10173|NCT02924090|"~     This is a randomized controlled study assessing the effect of pre-emptive hyperventilation~     on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in~     patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission~     of depressive symptoms with and without pre-emptive hyperventilation will also be studied.~   "
10174|NCT02924077|"~     Study was a non-interventional, prospective study of pregnant women who agreed to provide~     information about their medication use and certain lifestyle factors on a periodic basis~     throughout their pregnancy. Volunteers were recruited by measures such as placement of~     pamphlets near pregnancy test kits in pharmacies and by links from carefully selected~     websites and social networking sites. Subjects were invited to learn about the study either~     through visiting the study web site or phoning a telephone number where a recorded message~     described the study and invite eligible women to register for participation.~      Participants were asked whether they prefer to provide data via the internet or by~     interactive voice response system (IVRS).~      Data were collected in the predominant natural languages of the four study countries:~     Denmark, the Netherlands, Poland, and the United Kingdom (UK).~      Data were collected on use of prescription and non-prescription medication, as well as on~     use of herbals and homeopathic medications. More information was be collected from women who~     provided their response over the internet than by phone, in order to best utilize the full~     capacity of internet- based data collection.~   "
10175|NCT02924064|"~     This study is designed as a prospective, multi-centre, parallel group, double-blind~     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety~     of MP-513 (Teneligliptin) in combination with metformin.~   "
10176|NCT02924051|"~     Healthy eating can be difficult for people who live in poor, geographically isolated regions~     of the United States. In particular, people who live in Appalachia often experience food~     insecurity (i.e., their access to adequate food is limited by a lack of money and other~     resources at times during the year) and lack of access to healthy foods. This pilot study~     evaluates the effectiveness of motivational interviewing in helping individuals who live in~     these austere regions improve their diets in the context of limited resources and healthy~     food availability~   "
10177|NCT02924038|"~     This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2~     positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which~     surgical resection of the tumor is clinically indicated. Co-primary objectives are to~     determine: 1) the safety of the novel combination of subcutaneously administered IMA950~     peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the~     neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the~     response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in~     post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating~     patients.~   "
10209|NCT02923609|"~     The primary objective of the study is to investigate safety and efficacy of transendocardial~     CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and~     function, myocardial perfusion and electrical activity, biomarkers of neurohormonal~     activation, patient exercise capacity and clinical outcome.~      The secondary objective of the study is to better define the patophysiological background of~     HFpEF by the use of multimodality imaging platform, which will include data from~     electro-anatomical mapping, cardiac MRI, 2D and 3D echocardiography, high resolution~     electrocardiography, and cardiac catheterization~   "
10178|NCT02924025|"~     The aim of the study is to examine if motivational interviewing can have a positive effect~     on weight loss over a 6 month period. By losing weight, the investigators assume the~     patients will have a positive effect on quality of life, and also that weight loss will help~     to regulate the factors that are present with polycystic ovary syndrom (PCOS); such as~     menstrual disorders and infertility.~      Participants will be randomly assigned to a treatment group and a control group.~      Both groups will be followed as normal with blood samples and other tests such as scans of~     the ovaries and measurement of height and weight at the beginning of the study and after six~     months.~      In addition, there will be a small hair sample taken from the neck at the first consultation~     and after 6 months. This is done to measure the stress hormone cortisol in the body over the~     duration of the experiment.~      The treatment group receive individual motivational interviews by a nurse every 14 days for~     a period of six months. After half a year, tests are repeated to see if there are~     significant differences between the groups.~   "
10179|NCT02924012|"~     The aim of this study was to determine the energy demand and the potential to promote reduce~     blood pressure of an active video game (AVG). Fourteen hypertensive (56.4 ± 7.5 years) held~     a session AVG and traditional sedentary video game sessions (SVG) and walk (WAL), as~     negative and positive controls, in order determined randomly. During the sessions, they were~     observed oxygen consumption and energy expenditure (EE). Blood pressure (BP) and cardiac~     autonomic modulation (CAM) were measured at rest and every 15 minutes of a 60 minute period~     of recovery activities. It was also applied a rating scale of pleasure (enjoyment scale).~   "
10180|NCT02923999|"~     A randomised placebo controlled phase I trial of a monoclonal antibody which neutralises~     HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to~     assess the safety and reactogenicity~   "
10181|NCT02923986|"~     The primary objective of the Phase 1b study is to determine the dose-limiting toxicity (DLT)~     and maximal tolerated dose (MTD) of BP1001 and Dasatinib (Das) in patients with Philadelphia~     chromosome positive (Ph+) Chronic Myelogenous Leukemia (CML) in accelerated or blast phase.~     The primary objective of the Phase IIa study is to assess the efficacy of the combination of~     BP1001 and Das in patients with Ph+ CML.~   "
10182|NCT02923973|"~     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about~     15 million babies are born too soon every year, causing 1.1 million deaths, as well as~     short- and long-term disability in countless survivors. Few prognostic tests are available~     to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to~     be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The~     evidence supports the use of vaginal progesterone in singleton pregnancies with short~     cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton~     gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without~     prior PTB, nor in multiple gestations.~      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low~     risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a~     policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB~   "
10183|NCT02923960|"~     This is a randomized, double blinded, multi treatment, crossover study intended to compare~     the glycemic and insulinemic response after consuming liquid nutritional products in people~     with type 2 diabetes.~   "
10184|NCT02923947|"~     The purpose of this study is to assess the effect of severe renal impairment on the levels~     of AZD9291 in the blood in patients with advanced solid tumours compared to patients with~     normal renal function.~   "
10185|NCT02923934|"~     The three tumour streams that will be studied in this protocol are: (i) upper GI~     malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder~     cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and~     intestinal carcinoid tumours) and (iii) rare gynaecological tumours (including but will not~     be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade~     serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female~     genital tract and granulosa cell tumours).~      The role of immunotherapy is being defined in more common cancer types, however because of~     their rarity, the efficacy of immunotherapy for these cancers is poorly defined.~      This protocol provides an important opportunity to establish whether the combination of~     nivolumab & ipilimumab has efficacy in these cancers.~   "
10186|NCT02923921|"~     To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients~     with metastatic pancreatic cancer as measured by overall survival~   "
10187|NCT02923908|"~     The study is designed to see if, after tasting specific things, whether a child's facial~     pattern and voice pattern can determine the difference in something that has a sweet taste,~     no taste, and a bitter taste. The investigators will do this by comparing video recordings~     of a child's facial expression and voice to the child's response to follow-up questions~     after tasting three (3) different substances.~   "
10188|NCT02923895|"~     This single centre study will be used to investigate the efficacy of an experimental~     stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after~     short term use compared with a standard fluoride dentifrice.~   "
10210|NCT02923596|"~     Purpose of this retrospective study is to review and analyze the information and data that~     has been already been generated during the course of routine practice of medicine by the~     investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical~     care or medical advice for their keloid disorder.~   "
10211|NCT02923583|"~     The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ®~     following administration of a single-dose in healthy volunteers.~   "
10212|NCT02923570|"~     Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy~     tissues. It is possible that side effect rates with PBRT will be lower or the same compared~     to IMRT, but this has not been well studied to date. Although both of these radiation~     therapies have been used in the past to treat head and neck cancer, this research study will~     compare the effects of these two different radiation treatment modalities with each other to~     see whether PBRT is better, the same or worse than IMRT.~   "
10213|NCT02923557|"~     This clinical trial is designed to evaluate the efficacy of single immediate intravesical~     chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy~     for primary upper tract urothelial carcinoma (UTUC) patients.~   "
10189|NCT02923882|"~     Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries.~     About 28% of all neonatal deaths worldwide are directly attributed to LBW. Exposure to~     biomass fuel during cooking is associated with LBW. There is unlikely to be any significant~     change in the use of biomass fuels in the near future, therefore, interventions targeted to~     reduce the harmful effects on poor pregnancy outcomes is warranted. To address this need,~     the investigators proposed a locally-made inexpensive prefabricated model of the~     100-dollar-kitchen($100Kitchen) with an improved cookstove for resource-poor settings. The~     improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and~     thus, provided safeguard to the pregnant women using these fuels. This study has been~     measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a~     pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less~     likely to give birth to a LBW newborn. A cluster-randomized controlled trial has been~     adopted in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12~     weeks gestational age enrolled for each intervention and control area respectively and~     followed-up through 42-days post-delivery. Birth outcomes have been noted and the newborns~     have been weighted within 72-hrs of the delivery. Non-invasive maternal blood Carbon~     Monoxide Hemoglobin saturation (SpCO) level between the intervention and control groups have~     also been measured.~   "
10190|NCT02923869|"~     A cleft deformity of the lip and/or palate is one of the commonest major birth defects.~      Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its~     peculiarity lies in the numerous care management protocols proposed according to the~     surgical techniques used, operating time (between M3 and M18 of life), anesthetic technique~     and postoperative management.~      This surgery must be associated to a specific care management because of potential~     associated complications, especially the risk of obstruction of the upper respiratory tract~     and respiratory distress majored by the use of morphine anesthetics during and after~     surgery.~      Adequate postoperative analgesia in children is a vital part of perioperative care. Regional~     block given preoperatively in combination with general anesthesia (GA) provides good~     preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and~     complete recovery and reduced analgesic requirement in the postoperative period.~      CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the~     risk of postoperative respiratory depression and airway obstruction is important, and~     continuous monitoring is required during the initial 24-h postoperative period. Cleft palate~     surgery is not only painful, but may also compromise the airway, particularly in children~     with craniofacial syndromes. Opiate analgesia has the potential to further compromise the~     airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of~     respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is~     performed using a suprazygomatic approach and is based on a computer tomography study.~      The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves~     passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory~     innervation of the anterior and posterior palate, the upper dental arch, the maxillary~     sinus, and the posterior nasal cavity. Maxillary nerve block (MNB) through the~     infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits~     anesthesia of the entire palatine territory. However, this nerve block has led to~     complications such as orbital puncture, intracranial injection, maxillary artery puncture,~     or posterior pharyngeal wall injury.~   "
10191|NCT02923856|"~     As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the~     eradication rate of the Helicobacter pylori with the standard triple therapy failed to~     exceed 70% in China，and had to drop out of the first-line treatment recommendations.~     However, with the increase of treatment time, patients burden, adverse reactions of~     antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin~     is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of~     population, there are still more than 70% of the patients with clarithromycin sensitive.~     Under the guidance with susceptibility test，7-day standard triple therapy could be used. In~     this study, investigators will select the patients with infection of H. pylori and with~     clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on~     accurate susceptibility testing of clarithromycin will be studied. The treatment time will~     be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a~     sequencing for failed treatment patients in groups, such as drug resistance gene mutation,~     phenotype and genotype. Finally, investigators will compare the differences between the~     patients with triple therapy and traditional quadruple therapy.The incidence of adverse~     effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary~     economic losses at least 400RMB per person.~   "
10192|NCT02923843|"~     Frailty and multimorbidity is one of the biggest challenges of todays health care due to the~     demographic development with more and more elderly surviving many diseases that was mortal~     just a few decades ago. Health care in Sweden is one of the best in the world, yet many~     frail older people do not receive appropriate health care. Several reports have described a~     fragmented care with lack of good quality due to lack of a holistic view on the patient and~     her situation. At the same time the care given is costly and ineffective with a lack of~     continuity. Additionally, there are a lack of hospital beds in Sweden due to the ageing~     population and a cut down of beds in the last decades.~      There is though a method, Comprehensive Geriatric Assessment (CGA), where studies have shown~     many benefits for older patients including less need of hospital beds, better functional~     outcomes and a better chance of living at home after an Acute Hospital Discharge, but this~     method is not much used in Sweden.~      The aim of this study is to show that CGA in an Out-patient Care Setting save hospital beds~     without decreasing the quality of care measured by sustained functional capacity. Other~     parameters to be evaluated are mortality, degree of frailty, health economy, quality of~     life, and cognition.~   "
10193|NCT02923830|"~     The purpose of this study is to determine the safest and most effective flushing solution~     for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The~     complication rate in patients whose ports are flushed with saline only will be compared to~     the complication rate in patients whose ports are flushed with a combination of saline and~     heparinized saline.~   "
10194|NCT02923817|"~     The purpose of study is to determine whether autologous mononuclear cells deriving from the~     bone marrow are effective in the treatment of spinal cord injury.~   "
10195|NCT02923804|"~     This study is a prospective, randomized, placebo-controlled, double-blind trial to determine~     the effect of high concentrate omega-3 capsules on the omega-3 status of patients with~     non-alcoholic fatty liver.~   "
10196|NCT02923791|"~     This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar~     Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will~     receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg).~     Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on~     Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be~     conducted each of the two study periods. In addition, safety assessments will be conducted~     throughout the study.~   "
10198|NCT02923765|"~     Stroke rehabilitation of hemiplegics primarily lies in motor control and training of~     activities of daily life. Whole body aerobics is much less emphasized. Nonetheless,~     cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy~     people, which is prone to deconditioning. The present study aims to understand the efficacy~     of aerobic training in addition to the usual neuro-rehabilitation, including aerobic~     fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a~     prospective and randomized design. The subjects will be recruited from the hospitalized~     patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120~     hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined~     training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate~     intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5~     sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be~     employed as the training modality. It uses bilateral reciprocal movement of the arm coupled~     with the opposite leg, which allows for a push and pull motion. Additional 20 healthy~     participants will also be recruited as the healthy control. Assessment before and after~     training includes: (I) graded cardiopulmonary exercise test using constant-load stepper.~     (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin~     generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand~     factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor~     VIII, etc. [the 1st year]; (IV) monocyte-platelet aggregation and its subtypes, using flow~     cytometry [the 2nd year]. ( V) systemic inflammation, platelet activation and prognostic~     biomarker：C-reactive protein, soluble P-selectin, asymmetric dimethylarginine,~     Lipoprotein-Associated Phospholipase A2, etc [the 3rd year]. Statistical analysis will use~     ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after~     approval and end in 2019, July. We hope this investigation will establish a more~     comprehensive rehabilitation program for clinical application.~   "
10199|NCT02923752|"~     This is a new vessel wall imaging-based stroke registry which will investigate the clinical~     utility of the whole-brain intracranial vessel wall MRI technique in assessing the~     etiologies in patients with ischemic stroke.~   "
10200|NCT02923739|"~     The goal of this clinical research study is to learn if adding emactuzumab to the~     combination of paclitaxel and bevacizumab can help to control relapsed or refractory~     ovarian, fallopian tube, or primary peritoneal cancer. The safety and side effects of this~     drug combination will also be studied.~   "
10201|NCT02923726|"~     The primary objective is to understand the role of antitachycardia pacing (ATP) in primary~     prevention patients indicated for ICD therapy and programmed according to current guidance~     of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested~     in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock~     only to assess equivalency.~   "
10202|NCT02923700|"~     Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the~     treatment of osteoarthritis (OA) of different joints, in particular knee OA.~      In previous studies, it has been showed its potential to reduce pain and improve functional~     status in patients treated by simple intra-articular injections. However, there are several~     PRP formulation currently available in clinical use, and therefore it is very difficult to~     compare data coming from trials using different products. The most debated aspect concerning~     PRP formulation is the role of leukocytes, which might stimulate an early inflammatory~     response in the joint due to the release of metalloproteases and other pro-inflammatory~     cytokines.~      The investigators hypothesized that the presence of leukocytes in PRP could be clinically~     relevant in terms of outcome, so the present double blind randomized controlled trial was~     designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of~     knee OA.~      A power analysis has been performed for the primary endpoint of IKDC (International Knee~     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP.~     From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of~     0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points~     corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for~     each group. Considering a possible drop out of 15%, 96 patients per group are required for~     total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility~     criteria' section). Patients are then assigned to two different treatment groups, according~     to a randomization list. The first group of treatment consists of three weekly~     intra-articular injections of autologous leukocyte-rich PRP, whereas the second group of~     patients will be treated by three intra-articular injections of leukocyte-poor PRP.~      PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample~     will undergo 2 centrifugations (the first at 1480 rpm for 6 minutes to separate~     erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced~     20 ml of leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a~     special filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.~      The total amount of PRP will be divided into 4 small units of 5 ml each. One unit is sent to~     the laboratory for analysis of platelet concentration and for a quality test, 3 units are~     stored at -30° C.~      One week after the PRP production, the injective treatment starts, with 3 weekly injections.~     At the moment of the injection the syringe is properly covered to prevent the patient from~     discovering the substance he was receiving. After the injection, patients are sent home with~     instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on~     the affected area to relieve pain. During this period, the use of non-steroidal medication~     is forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
10203|NCT02923687|"~     Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on~     post endodontic pain in patients with symptomatic irreversible pulpitis.~      Design: Randomized double blind clinical trial~      Setting and conduct: Sixty adult volunteers with including criteria will be divided into two~     groups (n=30) based on random table. All patients will receive standard inferior alveolar~     nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration~     of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive~     supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group~     will receive buccal infiltration of normal saline. Endodontic access preparation will~     initiate after 15 minutes of initial IANB with two negative responses to the electric pulp~     test. The pain level will be recorded immediately and at the 2,4,6 and 24 hours following~     the treatment using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using~     Repeated measured test (if possible) and otherwise non-parametric tests such as rival~     Friedman and X2 test. Participants including major eligibility criteria: all patients age~     ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) and without pain on~     percussion on a mandibular molar tooth who need root canal treatment and are without~     systemic diseases; nonsmoking; non pregnant, non breast feeding without any medicine~     consumption or analgesic and sedation~      Intervention: Ketorolac infiltration~      Main outcome measures: Pain level at immediately after the treatment, 2, 4, 6 and 24 hours~     following the root canal treatment using HP VAS.~   "
10204|NCT02923674|"~     This study will help determine the appropriate type, amount and intensity of physical~     activity most beneficial for preventing weight regain after weight loss in older adults.~   "
10205|NCT02923661|"~     this study was conducted to clarify the effect of two different attachments on patient~     satisfaction and marginal bone loss. The primary and secondary objectives are to determine~     patient satisfaction and the marginal bone loss around implant when using CM LOC compared to~     conventional ball attachment. all the patients will receive a single median implant to which~     the denture will be loaded upon using the two different attachment systems~   "
10206|NCT02923648|"~     Obstructive lung disease is an increasing global health problem of pandemic proportions,~     with COPD alone affecting >10% of the population. Smoking is the main and most well studies~     risk factor for developing COPD. However, chronic airway obstruction also in never-smoking~     populations has recently been recognized as an increasing health problem. Prematurely born~     children, particularly survivors of bronchopulmonary dysplasia (BPD), defined as the need~     for oxygen therapy up to the 28th day of life for children born prior to gestational week~     32, have an increased incidence of both airway obstruction and hyper-reactivity, both~     representing major risk factors for developing COPD, or asthma, later in life. The purpose~     of this study is to perform in-depth clinical and molecular characterizations of of the~     lungs of survivors of BPD as they enter adulthood, and compare these profiles to relevant~     control groups (individuals with mild asthma, healthy prematurely born, and healthy~     individuals born at full term). Specifically, alterations at the epigenetic, mRNA, microRNA,~     protein and metabolite level as well as associated molecular pathways critical in the~     pathological mechanisms of obstructive lung disease related to premature birth and BPD will~     be identified.~   "
10207|NCT02923635|"~     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and~     its impact on patient satisfaction.~   "
10208|NCT02923622|"~     Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy~     extensively in China, no strong evidence exists to demonstrate the safety and survival~     outcomes of TCM herbal therapy combined with conventional western medicine for treatment of~     this disease. The purpose of this multi-center perspective cohort study is to evaluate the~     relationship between TCM herbal therapy and survival outcomes in patients with advanced~     colorectal cancer.~   "
10229|NCT02923349|"~     The purpose of this study is to determine the safety and tolerability and assess preliminary~     efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.~   "
10214|NCT02923544|"~     The purpose of this study is to test the feasibility and safety of using a new device called~     Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator.~     It is a reusable metal device designed to be simple and study. It is also adjustable in size~     which makes it easy for surgeons to use. It will be placed at the beginning of the surgery~     and removed at the end. This study will allow the researchers to find out if the surgeons~     find the YUMI effective and easy to use. It will also allow the researchers to see if the~     device is safe. This is the first time that the YUMI is being used in humans.~   "
10215|NCT02923531|"~     The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is~     safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab~     treatment has an effect on the body and the cancer tumor, in patients receiving nivolumab~     but not exhibiting a radiological response.~   "
10216|NCT02923518|"~     In 2010 there was published new European recommendations for assessment of adult and elderly~     men and women, who want to start with physical activity and/or participate in endurance~     contests. In this study we want to test if a group of people with positive score on a~     self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have~     more undetected heart diseases than a control group with no reported or detected risk~     factors.~   "
10217|NCT02923505|"~     The aim of the study is to test the hypothesis that treatment of sleep disordered breathing~     (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart~     failure (HF) with positive airway pressure (PAP) is associated with reduced risk for~     hospitalizations and death, lower health care utilization, and greater cost-effectiveness.~   "
10218|NCT02923492|"~     The translation study aims to refine and package intervention and training materials~     essential to translating an efficacious Emergency Department (ED) based Brief Intervention~     (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist~     remotely. The study will take place in two phases. During the Effectiveness phase, we will~     determine the effectiveness of the interventions [on-site therapist delivered BI + text~     messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a~     usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored~     text messages will be delivered daily for the first month post-discharge, and three times~     per week in the second month post-discharge to the BI groups. During the Implementation~     phase, components of the RE-AIM model will be assessed over a 4-month period.~   "
10219|NCT02923479|"~     The purpose of this trial is to determine the effectiveness, safety and tolerability of~     robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from~     work related ankle fractures, compared with conventional rehabilitation programs.~   "
10220|NCT02923466|"~     This is a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity~     of intratumoral administration of VSV-IFNβ-NIS in patients with refractory~     advanced/metastatic solid tumors.~   "
10221|NCT02923453|"~     Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in~     patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A~     total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover~     design, the participants are randomized to receive either placebo or American ginseng~     extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes~     treatment. Following ≥4-week washout period the participants are crossed over to another~     8-week treatment arm. Throughout the study period, all individuals maintain their original~     diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are~     fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1.~     Safety parameters include liver, kidney and hemostatic functions.~   "
10222|NCT02923440|"~     Congenital heart defects are seen in 0,8% of life births. In France this means more than~     5000 newborns per year. The south-east region of France is particularly affected as a result~     of a higher birth rate and consanguinity, when compared to other regions. The majority of~     congenital heart diseases remain unexplained. Genetic causes are indisputable but remain~     poorly understood. Genetic research needs the availability of a large-scale DNA collection,~     guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris~     (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a~     bank is currently unavailable in south-east France. To transport biological specimens from~     Marseille to Paris would be very expensive. In addition, the whole infrastructure required~     for correct diagnosis and classification of the congenital heart diseases, for sampling, for~     storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU~     research unit. For those reasons it is highly preferable to elaborate such a database and~     DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this~     DNA-bank~   "
10223|NCT02923427|"~     To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on~     ventilation parameters and surgical view during Trendelemburg Position laparoscopic~     gynecological surgery in cases administered positive pressure ventilation without the use of~     neuromuscular agents.~   "
10224|NCT02923414|"~     Atrial fibrillation is the most common heart rhythm disorder. For patients suffering atrial~     fibrillation direct current cardioversion is performed to reduce patients symptoms and~     prevent disease progression. The optimal energy selection for biphasic cardioversion is~     unknown.~      We aim to investigate the efficiency and safety of a high energy shock protocol (360 J)~     versus a standard escalating shock protocol (125-150-200 J) in cardioversion of atrial~     fibrillation.~   "
10225|NCT02923401|"~     The goal of this research study is to learn if there is a level of exercise training that is~     more effective in lowering biomarker levels that are linked to breast cancer risk.~     Biomarkers are found in the blood/tissue and may be related to your reaction to exercise.~   "
10226|NCT02923388|"~     This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in~     delaying the onset and reducing the incidence and severity of Vincristine Induced Peripheral~     Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.~   "
10227|NCT02923375|"~     The purpose of this study is to assess the safety, tolerability and efficacy of two~     infusions of CYP-001 in adults with steroid-resistant GvHD.~   "
10228|NCT02923362|"~     Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal~     reflux disease and hiatal hernia.~   "
10231|NCT02923323|"~     Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients~     will be recruited by research publication in diabetes mellitus forums.~      Baseline visit: informed consent signing. Medical history data, vital signs, physical exam~     and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl.~      Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment,~     neurocognitive testing, and sleep quality assessment.~      Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric~     Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS~     monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl~     and at glucose < 180 mg/dl, respectively.~      Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2.~     Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed~     with glucose level > 70 mg/dl and below 180 mg/dl.~      On day 2, with no regular insulin dose before lunch and the same cognitive test will be~     performed with glucose level > 240 mg/dl During the 30 hours the participants will be~     connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and~     research team will be blinded to the EEG and CGMS readings while recorded.~      Participants will be able to convey their daily activities in their room. They will have~     their regular diet and regular daily activities.~      Participants will measure at least 4 blood glucose measurements by prick tests, insulin~     management by multiple daily injections or pump therapy and meals.~      Healthy participants will measure twice daily as required for CGMS calibration. The~     participants will stay connected to the CGMS for additional 4 days at their home setting for~     complete sleep quality assessment by sleep diary and actigraph.~      The first night in hospital is to assess the association between actigraph and EEG and CGMS~     variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph~     readings.~      Control group (healthy) will perform only one session of neurocognitive studies on day 1,~     after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS~     and actigraph~   "
10232|NCT02923310|"~     OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of~     cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte~     formation and synovial inflammation. Although the causes of OA are still poorly understood,~     biomechanical stresses able to reach the articular cartilage and subchondral bone,~     biochemical changes in cartilage and synovial membrane, as well as genetic factors are~     important items in its pathogenesis. Although there is no cure for OA, treatment is directed~     to each individual patient, seeking to minimize pain, maintain or improve joint range of~     motion and limit disability. New therapies able to accelerate regeneration and tissue repair~     process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been~     shown to be an effective and safe treatment alternative in the fight against knee OA, in~     addition to HA, worth highlighting the therapeutic effects of growth factors derived from~     autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy,~     non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to~     evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and~     PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild,~     moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the~     procedures and randomly assigned randomly. In PRP be determined concentrations of the growth~     factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be~     conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of~     self-reported life. The walking and strength test will be performed before and during~     periods of 90.180 and 360 days after the first application. The main motivation for the~     development of this study is the lack of randomized, double-blind clinical studies in the~     literature, and also based on the favorable results researchers have obtained, both with the~     use of HA, as the use of PRP in accelerating the process scar, preventing the development of~     arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with~     synthetic HA play a synergistic action that should be studied in detail, in order to~     establish an effective therapeutic approach in the treatment of patients with knee OA.~   "
10233|NCT02923297|"~     Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's~     disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements),~     and non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates~     in the brainstem and extends progressively through the entire cortex. The processes leading~     to cell death are poorly understood. Pathological cells exhibit abnormal deposits, called~     Lewy bodies, which contain numerous proteins. A major constituent of these protein deposits~     is alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular~     Biophysics of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein~     interacts with Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin~     could thus be a factor regulating α-synuclein activity or aggregation. It is postulated that~     the level of expression of the GALIG gene is different in Parkinson's disease patients~     compared with control subjects.~   "
10234|NCT02923284|"~     The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of~     pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of~     leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study~     focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a~     reliable low-cost screening method at the point of service. If successful, our method would~     provide a diagnostic test to distinguish benign kidney masses from malignant ones,~     eliminating the need to surgically remove a kidney with a benign tumor.~   "
10235|NCT02923271|"~     Research participants and their parents will be recruited to take part in a randomized~     control trial. Participants' and their parents' cellphone use will be observed during an~     initial baseline period. Participants and their parents will then be randomly assigned to~     one of two conditions: opt-out blocking with parental notification, opt-out blocking with~     bidirectional notification.~   "
10236|NCT02923258|"~     This is a randomized,controled, phase III, open label study of postoperative concurrent~     chemoradiotherapy with Docetaxel versus Cisplatinum for high-risk squamous cell carcinoma of~     the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and~     safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.~   "
10237|NCT02923245|"~     The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound~     (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the~     ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the~     pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more~     quickly determine adequate bladder fullness to successfully perform transabdominal pelvic~     ultrasound than patient's perception of bladder fullness.~   "
10238|NCT02923232|"~     Presbyopes (people who might have a significant loss of their ability to accommodate their~     crystalline lens in the eye) will be recruited to wear a test lens and perform typical~     clinical tests of visual acuity with different luminance levels and viewing~     distances/angles.~   "
10239|NCT02923219|"~     The purpose of this study is to determine whether the adipose-derived stem cells therapy is~     effective in the treatment of facial rejuvenation.~   "
10240|NCT02923206|"~     This clinical investigation is a medical device trial to examine the safety and efficacy of~     TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.~   "
10241|NCT02923193|"~     Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind,~     randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard~     balloon angioplasty used in combination with DCB to treat moderate and severely calcified~     femoropopliteal arteries. Assuming that roughly 15% of the subjects will be~     lost-to-follow-up, a total of 334 subjects (167 per treatment arm) will be enrolled in the~     study.~   "
10243|NCT02923167|"~     This is an intervention study including a baseline data collection, 6 weeks of a training~     intervention with robotic-assisted manual training, a post-intervention data collection, and~     a 4 weeks post-intervention follow-up data collection. The study will be conducted in the~     Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, Boston, MA.This study aims~     to assess the effectiveness of a robot-assisted training on hand function and quality of~     life in children with cerebral palsy. Additionally, the investigators will study the~     relationship between muscle synergies and the outcomes of robot-assisted training.~   "
10244|NCT02923154|"~     The purpose of this study is to investigate the efficacy, safety, tolerability and~     pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.~   "
10245|NCT02923141|"~     The Purpose of this study is to see if it is possible to deliver an intervention that~     targets trauma, substance use, and engagement in HIV care with HIV-positive women.~   "
10246|NCT02923128|"~     The purpose of this study is to determine whether postoperative analgesia pump continuous~     infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and~     Postoperative cognitive dysfunction.~   "
10247|NCT02923115|"~     This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic~     Research Organization ARO and Clinical Research Organization CRO blinded),~     placebo-controlled, randomized, single-ascending dose, multi-center study to assess the~     safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in~     subjects with acute submassive pulmonary embolism.~   "
10248|NCT02923102|"~     The aim of the study is to investigate a pre and post workout supplementation (15 days) with~     Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects~     will be investigated with 400mg Recoverben® and compared to placebo.~   "
10249|NCT02923089|"~     This study will recruit 20 healthy adults (male and female) to complete 9 study visits where~     they will consume different food products (chili, soup and muffin) with or without lentils~     incorporated into the them. Blood samples will be obtained by finger prick before and for 2~     hours after the meal and analyzed for glucose and insulin.~   "
10250|NCT02923076|"~     Allogeneic hematopoietic cell transplantation from a CCR5 Δ32/Δ32 unrelated donor, performed~     for the first time in the Berlin patient, provides the only evidence to date of long-term~     control of HIV infection. Stringent criteria to select human leukocyte antigen (HLA)-matched~     conventional donors and low prevalence of the CCR5 Δ32/Δ32 homozygous genotype (<1%) made~     the pursuit of patient number 2 unsuccessful for many years. Cord blood (CB)~     transplantation allows more permissive HLA-matching criteria, making the search for~     HLA-compatible Δ32/Δ32 CB units potentially feasible for transplantation of HIV-infected~     individuals.~      The investigator team involved in this trial has recently reported the first such case of~     CCR5 delta32/delta32 CB transplantation in a patient with HIV infection, showing a reduction~     of the patient's latent viral reservoir and, upon achievement of full CB chimerism,~     resistance of his CD4 T-lymphocytes to infection by HIV. This proof of concept led the~     Spanish National Transplant Organization (ONT) to generate an inventory of over 150 CCR5~     Δ32/Δ32 CB units readily available for transplant.~      From this initial evidence and repository of CB units, financial support from the Fundación~     Mutua Madrileña (FMM) has allowed the investigators to launch this first pilot clinical~     trial in this indication. The study was launched in January 2016 at Hospital Universitario~     Puerta de Hierro Majadahonda. All HIV virology and reservoir analyses are carried out by the~     AIDS Immunopathology Unit at the Spanish Instituto de Salud Carlos III. Three additional~     transplant centres in Spain will also shortly open the trial.~   "
10251|NCT02923063|"~     Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of~     CKD with substantial adverse clinical consequences of disability, hospitalization, and~     death. Sarcopenia in this proposal is defined by impaired metabolism and physical function~     associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on~     mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial~     energetics is a central mechanism of sarcopenia in CKD. The investigators propose a series~     of studies designed to shed light on the pathophysiology of sarcopenia in persons with CKD~     not treated with dialysis. Investigators will conduct a randomized-controlled intervention~     trial of combined resistance training and aerobic exercise vs. health education to assess~     changes in skeletal muscle mitochondrial function, metabolism and physical function.~     Investigators hypothesize that exercise improves mitochondrial function and physical~     function in persons with CKD. If successful, these experiments will identify novel~     pathophysiologic mechanisms for CKD-associated sarcopenia. The proposed study will provide~     useful insight into benefits associated with exercise among patients with CKD and~     investigate mechanisms associated with improved metabolism, muscle function and physical~     function in population.~   "
10252|NCT02923050|"~     The purpose of this study is to determine effectiveness of a family meals intervention,~     Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight~     status.~   "
10253|NCT02923037|"~     This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in~     breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast~     cancer survivors with lymphedema as they directly support lymph transport (postures,~     breathing, relaxation) and emotional well-being (relaxation, meditation).~   "
10254|NCT02923024|"~     Oscar spends a significant amount of money every year on high cost high need individuals.~     With this increase in health care spending, Oscar Health is looking to expand care post~     emergency room and inpatient utilization for their members. In order to reduce hospital~     readmissions, reduce emergency room utilization, and increase the overall health of their~     members, Oscar is investing in a program to bring members better care through increased~     engagement with their primary care physician.~   "
10255|NCT02923011|"~     Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males~     between ages 10 and 20 years. The goal of the proposed study is based on the premise that~     MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain~     reduction following treatment of osteoid osteomas, and offers possible improvements with~     regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience,~     and/or 4) adverse events. The data from the current study would provide clinicians important~     information in deciding between treatment options for ablation of osteoid osteomas.~   "
10257|NCT02922985|"~     Opioid use and abuse has become a major medical problem in the United States. Over~     prescription of opioid medications is a major contributor to this growing problem. Cesarean~     delivery (CD) is the most commonly performed surgery in the US and women are generally given~     opioid medications for postoperative pain management. This is not a common practice in other~     developed countries. The investigators believe that a multimodal pain management strategy is~     superior to current practices for control of postoperative pain after CD and will lead to a~     decrease in the use of opioid medications. This will have beneficial effects on patients'~     recovery and bonding with their newborns, as well as societal effects in reducing the burden~     of opioid abuse in the US. The objective is to investigate the use of a multimodal pain~     regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo~     controlled trial. The multimodal intervention consists of a pre-operative dose of~     intravenous (IV) acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to~     skin incision, and a dose of intramuscular (IM) ketorolac at time of fascia closure. These~     study medications are currently used in the patient population but not in a standardized~     fashion, not in every patient, and not always in combination with each other. The control~     group will receive placebo IV infusion preoperatively and an IM injection at fascia closure,~     and subcutaneous infiltration with normal saline before skin incision. Both groups will~     receive spinal regional anesthesia as per anesthesia team. Post-operatively, both groups~     will receive the current standard of care, which consists postoperative~     hydrocodone/acetaminophen and ibuprofen as needed depending on pain score. The primary~     outcome of interest will be the total opioid intake in the first 48 hours after surgery.~     Secondary outcomes include time to first opioid requested, pain scores at 6-12, 24 and 48~     hours post op, and total number of opioid tablets left after discharge on post op day number~     7. Additional outcomes include patient satisfaction scores and total length of hospital~     stay. The hypothesis is that our multimodal pain regimen will decrease the total opioid~     requirement in the first 48 hours after surgery.~   "
10258|NCT02922972|"~     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich~     Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars~     refractory to conventional treatments. Fifteen patients were included and received three PRP~     injection sessions with a one-month interval. The outcomes were assessed at baseline (before~     treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by~     reported adverse event analysis.~   "
10259|NCT02922959|"~     This project will further develop and test the Tailored Telephone Intervention delivered by~     Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention~     to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a~     non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO~     (NCT02282306) found that the participating patients and the Peer Interventionists were~     satisfied with their participation, the intervention was acceptable, and the system for~     generating patient-tailored intervention information performed well. The overall goal of the~     present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control~     group. It is hypothesized that patients in the TTIP-PRO group will have more favorable~     drug-abuse-related outcomes than patients in the control group.~   "
10260|NCT02922946|"~     The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal~     on the single dose pharmacokinetics of entinostat and to evaluate the safety and~     tolerability of entinostat under fed and fasting conditions in healthy adult subjects.~   "
10261|NCT02922933|"~     The purpose of this study is therefore to evaluate the effect of concomitant drugs known to~     affect solubility of drugs through increase of intra-gastric pH levels on the~     bioavailability of entinostat.~      The primary objectives of this study are to evaluate the effect of multiple doses of~     omeprazole, famotidine, and the effect of an acidic beverage on the single-dose PK profile~     of entinostat.~      The secondary objectives are to evaluate the safety and tolerability of a single dose of~     entinostat when administered with multiple doses of omeprazole, famotidine, and when~     administered with an acidic beverage.~   "
10262|NCT02922920|"~     Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert~     anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about~     the effects of drinking tart cherry juice on cardiovascular and cognitive health.~   "
10263|NCT02922907|"~     Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation~     for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.~   "
10264|NCT02922894|"~     This study will investigate potential therapeutic approaches for sleep-disordered breathing~     (SDB) in patients with chronic cervical spine injury (>6 months post-injury).~   "
10265|NCT02922881|"~     Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has~     long been considered to be due to a dysregulated immune response targeting the colon, and~     involves unknown environmental factors. Currently, no effective therapy targets the~     microbiota or its interaction with the colonic epithelium. Diet has a significant impact on~     the composition of the microbiota; however, no dietary intervention to date has proven~     effective for induction of remission. The primary objective of this study is to determine~     whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC~     patients with active mild to moderate UC on a stable medication.~   "
10266|NCT02922868|"~     The purpose of this research study is to compare the effectiveness and efficiency of using a~     sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.~   "
10267|NCT02922855|"~     A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6~     months of enrollment in a health care coverage program. Study subjects are drawn from a~     low-income adult population that gains coverage and access to community-based primary care~     services under a program administered by an academic safety-net hospital. The investigators~     will offer financial incentives to encourage an initial primary care visit within 6 months~     of enrollment and evaluate whether the primary care visit altered subsequent health seeking~     behavior and influenced patient satisfaction and other outcomes such as self-reported health~     status.~   "
10268|NCT02922842|"~     The purpose of the study is to compare patient centered- outcomes between Transcutaneous~     Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence.~     One of these locations will be along the tibial nerve, which is traditionally accessed near~     the medial malleolus. The second site will be on the sacral nerve which is accessed over the~     sacrum. The third site will be a sham site on the shoulder. This study will evaluate the~     feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.~   "
10269|NCT02922829|"~     The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year~     collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's~     primary goals were: a) to determine the differential impacts of food insecurity on~     gestational weight gain and prenatal depression, and b) to elucidate the mechanisms~     underlying the relationship between food insecurity and weight gain and/depression among HIV~     infected and HIV uninfected pregnant women in Gulu, Northern Uganda.~   "
10270|NCT02922816|"~     Transplant patients are at increased risk of colonization and infection with Multidrug~     Resistant Organisms (MDROs) due to medications that modify their immune systems, increased~     healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study,~     kidney transplant patients who have infections with resistant bacteria will be given a Fecal~     Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic~     treatment. This study will see if FMT will eliminate the resistant bacteria so that the~     kidney transplant patients do not have to use last resort antibiotics.~      This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant~     patients to support the rationale for a subsequent clinical trial, not to establish efficacy~     or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes,~     assess feasibility, and refine the target population in participants with MDRO colonization~     and intestinal dysbiosis. Data from this study should provide directions for the design of~     future clinical trials.~   "
10271|NCT02922803|"~     Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th~     parallel were observed to be weak and to have a waddling gate.~      Study 1 was carried out in the setting of an antenatal clinic administered from a primary~     care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in~     Sweden. The investigators chose an initial study period in late spring to reflect the~     effects of the dark season with little ultraviolet B radiation that affects vitamin D~     production. Study 1 was carried out in a short period of time. The recruitment was performed~     in a retrospective design in order to neglect the seasonal effects of ultraviolet B~     radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of~     blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance~     in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71).~      Study 2: Examines the results on muscular performance, i.e. grip strength and squatting~     ability, from intervention with advice and prescription of vitamin D3 and calcium for 10~     months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.~      Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on~     delivery outcome in birth protocols starting 2016.~      Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and~     strength in the group of Somali women by focus interviews among the Somali women from above.~      A possible fifth study will explore correlations between 25-OHD and pain distribution and~     pain parameters.~   "
10272|NCT02922790|"~     The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid)~     damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes~     cessation.~   "
10273|NCT02922777|"~     This study is being done to evaluate the safety of the investigational study drug, BGB324~     when administered in combination with docetaxel, and to establish the maximum tolerated~     dose.~   "
10274|NCT02922764|"~     Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of~     RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR,~     resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor~     blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from~     attacking tumors.~      During the dose escalation stage, multiple doses and schedules of orally administered~     RGX-104 will be evaluated in patients with advanced solid tumors and lymphoma (i.e., locally~     advanced and unresectable, or metastatic) who have had progressive disease (PD) on available~     standard systemic therapies or for which there are no standard systemic therapies of~     relevant impact. In the expansion stage of the study, additional patients with melanoma,~     non-small cell lung cancer, epithelial ovarian carcinoma, or breast cancer will be treated~     at the MTD (or maximum tested dose if no MTD is identified, or dose below the MTD if there~     is evidence suggesting a more favorable risk/benefit profile) to provide further~     characterization of RGX-104 safety, efficacy, PK, and pharmacodynamics, including biomarkers~     of immunologic activity and LXR target activation.~   "
10275|NCT02922751|"~     Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of~     pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic~     evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and~     risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and~     quantify liver fibrosis.~   "
10276|NCT02922738|"~     Health care providers use a variety of computerized medical information sources to reduce~     knowledge gaps and support patient care decisions. Few studies have evaluated the impact of~     medical information sources on patient outcomes. Skin problems are the reason for many~     visits to primary care providers and result in a high percentage of referrals to~     dermatologists and return visits to primary care for the same skin problem.~      The objective is to evaluate the impact of primary care providers' use of a dermatology~     information source, VisualDx, on skin problems outcomes.~      The study design is a cluster-randomized controlled trial. Participants include primary care~     providers as clusters and their patients with skin problems. Providers are randomized to~     intervention group that refers to VisualDx when seeing a patient with a skin problem, or to~     the control group who does not. Patients have the randomized group status of the doctor they~     saw for the problem.~      Patients are interviewed to determine the problem status and how many follow-up visits they~     had for the problem at intervals after the index visit.~   "
10277|NCT02922725|"~     The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g~     creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-HTP) twice daily reduces~     hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale~     (HAM-D) in women with SSRI- or SNRI-resistant depression, combined with the examination of~     changes in functional connectivity based on resting-state fMRI and changes in brain~     metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.~   "
10278|NCT02922712|"~     Study is conducted to evaluate safety and efficacy in patients with osteoarthritis~   "
10279|NCT02922699|"~     Comparison of efficacy of H.pylori eradication during first line therapy using standard or~     high doses of omeprazole administered twice daily in combination with amoxicillin and~     clarithromycin for 10 days.~   "
10359|NCT02921867|"~     The investigators hypothesise that simulation-based training will have initial educational~     benefits and in coherence with the traditional apprenticeship model will heighten the~     educational end-level: That training on the simulator before clinical education will prepare~     the trainee for practice and thereby support more effective learning.~   "
10280|NCT02922686|"~     The main objective of this study is to investigate the non-inferiority of oral~     flucloxacillin alone compared with a combination of oral flucloxacillin and~     phenoxymethylpenicillin for the emergency department directed outpatient treatment of~     cellulitis, wound infections and abscesses, recently renamed by the Food and Drug~     Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half~     of the trial participants will receive flucloxacillin and placebo in combination, and the~     remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.~      In a secondary objective the trial aims to measure adherence and persistence of trial~     patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the~     cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin~     compared with combination therapy from the perspective of the health-care payer (direct~     costs) the patient and government. Finally the study will externally validate the Extremity~     Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed~     to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in~     clinical trials.~   "
10281|NCT02922673|"~     Rationale:~      The last years, research focus has moved to immunostimulatory agents in order to restore or~     increase the functionality of the immune system during sepsis-induced immunoparalysis.~     Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is~     associated with improved outcome of sepsis. Experimental data indicate that ASA exerts~     pro-inflammatory effects during systemic inflammation. However, it remains to be determined~     whether treatment with ASA improves immune function once immunoparalysis has developed and~     whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the~     former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced~     immunoparalysis. In the latter case, ASA may have a broader indication as an~     immunomodulating agent. Taken together, ASA might be a promising, cheap, well-known, and~     globally available agent to reduce the incidence of secondary infections and improve patient~     outcome in sepsis.~      Objective:~        -  To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance,~          which is expressed as a decrease in pro-inflammatory cytokine levels between the first~          and second endotoxin challenge.~        -  To determine whether acetylsalicylic acid prophylaxis can prevent endotoxin tolerance,~          which is expressed as a decrease in pro-inflammatory cytokine levels between the first~          and second endotoxin challenge.~      Study design:~      Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during~     repeated experimental endotoxemia. All subjects will receive a 14 day course of study~     medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide~     (LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus~     of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.~      Subjects are randomized in three study arms:~        1. Treatment group: 7 days placebo / first endotoxemia / 7 days ASA 80 mg (loading dose on~          first day of 160mg) / second endotoxemia~        2. Prophylaxis group: 7 days ASA 80 mg (loading dose on first day of 160mg) / first~          endotoxemia / 7 days ASA 80 mg / second endotoxemia~        3. Placebo group: 7 days placebo / first endotoxemia / 7 days placebo / second endotoxemia~   "
10282|NCT02922660|"~     This is a single-center, randomized, prospective research which aims to investigate the~     advantages and disadvantages between desflurane balanced anesthesia and TIVA in ophthalmic~     ambulatory surgery, so that to evaluate a better anesthesia method in ophthalmic surgery~     through a large sample clinical study.~   "
10283|NCT02922647|"~     The urpose of this study is to compare the urinary tract infection rate on the four~     postoperative day between the 2 groups of patients who have undergone total mesorectal~     excision for cancer and low anastomosis, with either suprapubic or transurethral~     catheterization.~   "
10284|NCT02922634|"~     The objectives of this study are to determine whether identifying patients with baseline~     cognitive deficits through preoperative cognitive screening may aid patient, family, and~     surgeon decision-making; inform and potentially improve anesthetic management and improve~     patient safety by identifying risk for postoperative morbidity.~      Aim 1. Assess the marginal benefit of structured preoperative cognitive screening relative~     to standard or systematic preoperative evaluation for identifying seniors with likely~     cognitive impairment.~      Aim 2. Determine whether preoperative cognitive impairment predicts postoperative outcome.~   "
10285|NCT02921581|"~     Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in~     intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also~     apply for recurrent and second primary head and neck cancers in previously irradiated~     volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy~     using IMRT dose-painting by contours for patients with recurrent and second primary head and~     neck cancer.~   "
10286|NCT02921568|"~     This study is designed to evaluate and compare in-tissue performance of OCT scans on the new~     Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.~   "
10287|NCT02921555|"~     The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses~     added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.~   "
10288|NCT02921542|"~     To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a~     predetermined laser treatment protocol in patients presenting with varying lesion types or~     morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous~     (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of~     calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment)~     associated with peripheral arterial disease (PAD).~   "
10289|NCT02921529|"~     The purpose of this study is to observe the effects of transcutaneous electrical acupoint~     stimulation(TEAS) on postoperative recovery after colon surgery.~   "
10290|NCT02921516|"~     Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle~     income countries, both have risen among youth. In addition, HIV-infected youth achieve~     inferior treatment outcomes compared to their adult counterparts in both high- and~     low-income countries, and these poorer outcomes are generally attributed to suboptimal~     adherence. Thus, there is a critical need for the development of adherence and risk~     reduction interventions for the growing cohort of these youth, and the proposed cognitive~     behavioral N'ap Grandi is one such intervention.~   "
10291|NCT02921503|"~     The study aims to evaluate the effectiveness of a mobile application to assist in the~     prescription of topical corticosteroids (TCS), focusing on best fit choices of potency,~     vehicle and volume. The mobile application will be developed from the results obtained in a~     systematic literature review and quality assessment of clinical practice guidelines for~     topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE~     II tool. After the app user enters in information concerning patients' rash location and~     desired treatment duration, the app will generate a list of recommended topical steroids~     (focusing on specific quantity and potency) for the patient's particular area of need. The~     objective of the study is to evaluate whether the use of a standardized application will~     change prescribing practices for primary care physicians, physician assistants and nurse~     practitioners.~   "
14067|NCT02873169|"~     Determination of risk factors of ventricular arrhythmias (VAs) after implantation of~     continuous flow left ventricular assist device in order to characterize which patient~     requires ICD implantation in primary prevention.~   "
10292|NCT02921490|"~     Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost~     wages, etc) annually. The most common source is low back pain (LBP), often from facet~     joints. The clinical evaluation of facet joints is challenging and anatomic imaging findings~     of facet joint; degenerative change; correlate poorly with pain. Therefore, it is difficult~     to select appropriate candidate patients/facet joints to treat. Misguided percutaneous~     treatment can cost thousands of dollars per session and delay diagnoses. Very limited~     retrospective information suggests that high grade peri-facet MRI signal change correlates~     to the side of LBP. However, this has not fully characterized the imaging findings and has~     not correlated to expert clinical exam/percutaneous response, precluding robust and~     meaningful clinical impact. Minimal retrospective data concludes inflammatory changes can be~     identified on FDG-PET exams, but the evidence of correlation to patient pain is lacking.~     Limited DWI exists for inflammatory spondyloarthropathies and myopathies, but is also~     lacking.~      This is an exploratory study investigating the utility of FDG PET activity and MRI signal~     change around facet joints in the clinical management of low back pain. This study will help~     determine if such imaging biomarkers could change clinical management. Additionally, this~     will provide data that will be vital to planning a larger prospective study evaluating the~     ability of imaging biomarkers to predict response to comparison medial branch blocks and RF~     ablation for treatment of facet joint pain.~   "
10293|NCT02921477|"~     The present study is designed as an open label study of patients with mild cognitive~     impairment or dementia to evaluate longer term tolerability and potential efficacy of~     tyrosine kinase inhibitors. Baseline and outcome measures in this study utilize validated~     tests that are appropriate for repeated measures which are not affected by practice effects.~     Advantages of this study include the fact that the neuropsychological testing instruments~     and advanced MRI imaging protocols that have been in routine clinical deployment provide for~     a high degree of availability and reliability for diagnosis and for monitoring change of~     status. Quality assurance is tightly controlled. The study population is sufficiently broad~     and the conditions of interest are sufficiently prevalent so that recruitment of the~     projected numbers of subjects is not a limiting factor.~      For a Phase I trial there is a proposed 20 patient sample to determine the frequency of~     common side effects in the population that is being studied. Subjects will be administered~     the initial dose of bosutinib, with dosage progressively increased over the course of the~     study. The initial dose of bosutinib is 100 mg tablet, once per day. The dose will be~     increased as tolerated up to 300 mg per day.~      All subjects will be started at 100 mg/day and the dose will be increased by 100 mg each~     month if the lower dose is tolerated without significant side effects. That is to say, the~     subject will take 100 mg/day every day for the first month, 200 mg/day every day for the~     second month, and 300 mg/day every day for the third month and for the remainder of the~     study, provided that adverse reactions do not prohibit continuation at this dosage. The~     investigators will be using the Common Terminology Criteria for Adverse Events (CTCAE)~     Version 4.0 to monitor, evaluate, and report adverse reactions on an ongoing basis. Stopping~     and dose reduction rules for reported adverse reactions have been taken from the package~     insert of bosutinib.~   "
10294|NCT02921464|"~     Florida Cardiovascular Quality Network Application of Clinical Decision Support Software~     Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality~     Outcomes Registry~   "
10295|NCT02921451|"~     The purpose of this study is to determine the long term performance of Restorelle system for~     the treatment of uterine prolapse.~   "
10296|NCT02921438|"~     The study is a prospective multi-centre observational study to evaluate a portable~     magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who~     present to the emergency department with chest pain and other symptoms consistent with ACS.~   "
10297|NCT02921425|"~     This study was a pilot 3-month clinical trial that investigated the feasibility,~     effectiveness, and acceptability of using the Track Health function of the Veterans Health~     Administration's patient health record for effecting a more positive physical activity (PA)~     and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with~     prediabetes. Baseline and three-month post-intervention outcomes were measured in two main~     domains: objective (e.g., weight) and subjective (e.g., self-efficacy).~   "
10298|NCT02921412|"~     This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month~     dispensing study~   "
10299|NCT02921399|"~     After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H.~     pylori) infection is advised to reduce metachronous recurrence. However, few studies have~     addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none~     have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the~     investigators will conduct to evaluate whether differences in timing of eradication therapy~     after ER of gastric tumors.~   "
10300|NCT02921386|"~     A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine~     the effect of meals of various amounts of fat given immediately prior to dosing on the~     pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects~     will be dosed for a 14 day run-in period. This will be followed by a randomized sequence of~     five periods over a 6 day confinement period. Subjects will receive a randomly ordered~     sequence of breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and~     a high fat breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed~     Bioequivalence Studies.~   "
10301|NCT02921373|"~     Cell-based therapies in the form of stem cell-based or immune cell-based therapies are~     becoming important treatment options that are either approved for clinical use or are~     showing promise in clinical trials. One of the issues regarding cell-based therapies is~     that, once the cells are injected into a subject, there is no easy way to track where they~     go, assess whether adequate numbers of cells arrive at the intended therapeutic target and~     for how long they persist at a given location. To address this issue non-invasive imaging~     methods have been developed using magnetic resonance imaging (MRI). When used with an~     appropriate cell labelling contrast agent, Cellular MRI can track cells non-invasively in~     vivo. Detection of cells is accomplished with an inert imaging agent containing the MRI~     sensitive fluorine-19 (19F) nuclei. The objective of this study is to demonstrate that~     19F-MRI is safe to use in humans so that it can subsequently be used to track cell-based~     immunotherapies in future clinical trials. The long term goal is to be able to quantify~     immune cell migration to secondary lymphoid tissues and potentially to tumors and correlate~     to therapeutic outcomes.~   "
10302|NCT02922608|"~     High fidelity simulation provide educational skills but the simulation of critical events~     could eventually provide anxiety among participants.~      The anxiety could raise before the simulation session and affect the perceived quality of~     sleep the night prior to the simulation session. The lack of sleep would eventually affect~     both participation and memorization during the simulation session. The investigators would~     like to investigate with a survey how much participants had their sleep affected before the~     simulation session.~   "
10303|NCT02922595|"~     The primary purpose of this study is to compare with a non-inferiority randomised study the~     new laryngeal tube (Intubating Laryngeal Tube Single-Disposable - iLTS-D) to the~     well-established Intubating Larygeal Mask Airway (ILMA/ Fastrach) for the success rate and~     time for intubation under fiberoptic control. Secondary purposes are success rates and times~     for ventilation for both devices and finally success rate of gastric tube placement.~   "
10304|NCT02922582|"~     This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in~     subjects scheduled to undergo total knee arthroplasty (TKA). Approximately 60 subjects (15~     per arm) are planned for enrollment. Subjects will be randomized in a 1:1:1:1 ratio to~     receive either DepoTXA 400 mg, DepoTXA 800 mg, DepoTXA 1200 mg, or IV TXA (Cyklokapron® 1~     gram).~   "
10305|NCT02922569|"~     This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess~     the safety and efficacy of an experimental software program designed to improve cognitive~     functions versus a computer-based software control. Both the study and the software being~     investigated meet the criteria of Non-Significant Risk. The primary objective of this study~     is to evaluate the effects of combination of mindfulness training (MT) and adaptive~     cognitive training (CT) on the cognitive abilities, functional status and quality of life of~     soldiers and veterans diagnosed with traumatic brain injury (TBI, also referred to as a~     concussion, or blast exposure), as compared to a computer-based control.~   "
10306|NCT02922556|"~     To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for~     depression (Moodify) versus an active control treatment (commercially available computer~     games).~   "
10307|NCT02922543|"~     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as~     Revlimid) in patients with relapsed or refractory multiple myeloma (hereinafter referred~     to as relapsed or refractory MM) who have received long-term treatment with it under the~     actual condition of use.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled,~          300, is reached (estimated to be approximately 1 year and 3 moths).~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid~          (estimated to be approximately 4 years and 3 months).~   "
10308|NCT02922530|"~     The overall goal of this research proposal is to develop an adjunct to standard treatments~     that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly~     treating these core deficits via targeted behavioral training should slow the progression of~     PD, assure greater resilience against future decline, and improve the quality of life of~     many living with PD. The purpose of this exploratory research study is to determine the~     benefits, if any, of the mobile device-based treatment described above in individuals with~     PD.~   "
10309|NCT02922517|"~     Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)~   "
10310|NCT02922504|"~     A surgical abortion under local anesthesia is potentially painful. A protocol using~     analgetic is systematically used. Also the protocol is relevant , the question of taking~     care of the pain in a safe manner remains.~      The use of Music during surgery can have a real effect on pain and anxiety. This study has~     for goal to evalued the use of music on pain as adjuvant treatement instead of a standard~     care for an abortion.~   "
10311|NCT02922491|"~     It is a study of clinical and interventional character, in which individuals who participate~     in the intervention will be selected for convenience of the project database entitled~     Second Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable~     Disease More Prevalent Population of the city of João Pessoa / PB . They will be invited to~     participate in the intervention female subjects, overweight or obese, aged 20 and 59 years.~     The selected individuals will be distributed randomly into three groups: receive daily~     supplementation of 01 capsules containing 400 mg of vitamin E synthetic source (Group 1);~     receive daily supplementation of 01 capsules containing 400 mg of natural source vitamin E~     (Group 2); and receive daily supplementation of 01 placebo capsule (control group).~     Individuals of all groups will receive dietary plan respecting individual needs, in order to~     control weight during the 08 weeks period. This project aims to evaluate whether vitamin E~     supplementation may modify the methylation profile of microRNA-9-1 and microRNA-9-3.~   "
10312|NCT02922478|"~     This study aims to create a database of patients with stable and chronic heart failure with~     comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate~     cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to~     disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine~     samples will be stored to facilitate future biomarker analyses.~   "
10313|NCT02922465|"~     The primary objective of this study is to assess the effects of clopidogrel on the PK of~     K-877 in healthy adult subjects.~   "
10314|NCT02922452|"~     This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with~     parameters like Cmax, AUC(INF), and AUC(0-T).~   "
10315|NCT02922439|"~     The purpose of this study will to be to evaluate the effects of a mobile intervention~     focused on improving the chronic disease self management skills of individuals with low~     health literacy. The intervention will provide information that culturally and~     linguistically tailored to participants' level of health literacy.~   "
10316|NCT02922426|"~     This study will characterize insulin sensitivity in response to treatment with ALKS 3831,~     olanzapine, and placebo.~   "
10317|NCT02922413|"~     The purpose of this study is to determine if Panhematin is safe and effective for prevention~     of acute attacks of porphyria.~      The study aims to provide high quality evidence for the use on hemin for prevention of acute~     attacks of porphyria. A separate study is in progress to evaluate the use of Panhematin for~     treatment of acute attacks of porphyria. Such studies have not been done previously for~     treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of~     hemin for treatment and prevention of attacks limits its availability for patients with~     acute porphyrias.~   "
10342|NCT02922088|"~     The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose~     vascular grafts have been treated with DuraGraft. All participating sites will be from~     countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and~     post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes~     and patient reported quality of life over a period of 5 years.~   "
10318|NCT02922400|"~     The primary objective of this study is to determine the efficacy and feasibility of a~     battery of neuropsychological measures evaluating social cognition and behavior in young~     adults diagnosed with schizophrenia, autism spectrum disorders, or traumatic brain injury~     (TBI). It also investigates functional differences in regions of the brain associated with~     social cognition and differences in cognitive processing. Additionally, this study~     implements a virtual reality intervention to strengthen social cognition skills.~   "
10319|NCT02922387|"~     Prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination~     with behavioral support with one session of behavioral support alone.~      Eligible patients were smokers hospitalized due to a) acute exacerbation of chronic~     obstructive pulmonary disease (COPD), or b) bronchial asthma attack, or c)~     community-acquired pneumonia (CAP).~      The primary outcome was the success rate (%) at week 52. Secondary outcomes were quality of~     life (QoL) alterations on the domains of the 36-Item Short Form Health Survey (SF36) and~     investigation of possible predictors for smoking abstinence.~   "
10320|NCT02922374|"~     For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the~     first-line treatment in the guideline, but patients have a great risk of requiring colectomy~     or turning to second-line treatment. This study aim to verify the effectiveness of~     ulcerative colitis endoscopic index of severity(UCEIS) in predicting the reaction to~     corticosteroids, and explores the possibility that noninvasive marker fecal calprotectin~     (FC) could act as an alternative to UCEIS.~   "
10321|NCT02922361|"~     This project will use data from a large network-model health maintenance organization that~     operates Medicare Advantage (MA) plans (CareMore) and fee-for-service Medicare data to (1)~     better understand the characteristics of high-need, high-cost MA enrollees patients and (2)~     evaluate the impact of a care management program focused on high-need high-cost MA enrollees~     with end-stage renal disease.~   "
10322|NCT02922348|"~     The investigators intend to establish feasibility/acceptability of a pilot randomized trial~     comparing hormone replacement therapy (HRT) and combined oral contraceptives (COCs) in women~     with premature ovarian insufficiency to estimate differences in quality of life (QOL) and~     serum hormone assays and markers of bone turnover/cardiovascular risk. At baseline, QOL~     survey will be administered and serum testing performed. Patients then randomized to HRT or~     COCs. Repeat testing will be performed after 3 and 6 months.~   "
10323|NCT02922335|"~     This study's purpose is to test the effectiveness of a promising intervention for emerging~     adults (EAs) with mental illness (MI) and serious antisocial behavior in achieving the~     ultimate outcome of reduced antisocial behavior, and proximal intermediate outcomes.~     Multisystemic Therapy-Emerging Adults (MST-EA) is an adaptation of MST, a well-established,~     effective intervention for antisocial behavior in adolescents.~   "
10324|NCT02922322|"~     To analyze the effectiveness of mat Pilates compared to no intervention in individuals with~     chronic nonspecific low back pain.~   "
10325|NCT02922309|"~     People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal~     training in order to improve communication efficiency and quality of life. However,~     participation in vocal training of elderly is often restricted by motivation, time of~     practice, and availability to hospital, which thus reduces treatment effects. The purpose of~     the study is to design a telecommunication vocal training system and a vocal training~     program for voice disordered elderly in Taiwan. The investigator proposed a 3-year~     consecutive study, including a single-blind, randomized controlled trial, to test the~     hypothesis that vocal training via telepractice for voice disordered elderly are not~     inferior to the standard face to face training.~   "
10326|NCT02922296|"~     The purpose of the study is to better understand how the body handles sugars glucose and~     fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain~     persons at risk to develop diabetes. This understanding may help us to find new treatments~     to control blood sugar and prevent diabetes in people with and without sickle cell disease~     (SCD).~      In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find~     genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA~     will be used for studies designed to find out how genes are doing their job of eventually~     producing proteins.~   "
10327|NCT02922283|"~     T cell infiltration of tumor lesions is a known prognostic factor in several tumor types and~     is used as treatment mechanism in some of these tumor types. In metastatic melanoma,~     treatment with immune checkpoint inhibitors induces clinical benefit in about 30-50% of the~     patients. These immune-based therapies are however accompanied by serious immune-related~     adverse events and high costs.~      Tumor infiltrating T cells express the high affinity interleukin-2 (IL2) receptor on their~     surface. These T cells could therefore be visualized by molecular imaging with a~     radio-labelled ligand for this receptor. For this purpose, the investigators have developed~     the PET tracer [18F]FB-IL2.~      The study commences with a biodistribution study (phase 1) in 5 subjects. Thereafter the~     main study (phase 2) starts, in which 25 subjects will receive two [18F]FB-IL2 PET scans at~     baseline and week 6 of treatment with either ipilimumab, nivolumab, pembrolizumab or the~     combination of ipilimumab and nivolumab. If [18F]FB-IL2 PET is able to detect a response to~     treatment, it could serve as a non-invasive early indicator of T cell response to the~     treatment. Besides, accumulation of the PET tracer in non-target tissue could indicate~     infiltration of activated T cells in normal organs and thus may predict the development of~     an immune-related adverse event.~   "
10328|NCT02922270|"~     INTRODUCTION AND AIMS: The aims of this study were to evaluate patient and technique~     survival rates, investigate peritonitis rates and evaluate factors affecting mortality in~     peritoneal dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine~     Peritoneal Dialysis Unit.~      METHODS: Two hundred seventy seven patients have received PD as renal replacement therapy~     (RRT) over a period of 20 years. After exclusion of patients with follow-up shorter than 3~     months and patients whose data were not available, 250 patients were examined~     retrospectively. Data for sex, age, primary disease, comorbidities, follow up duration,~     cause of death, and cause of technique failure were collected from medical records.~   "
10343|NCT02922075|"~     This study evaluates the impact of soft tissue grafts on soft tissue recession following~     immediate implant, provisional and bone graft placement in compromised sockets. One third of~     the patients received a collagen matrix (CM group), another third received a connective~     tissue graft removed from the palate (CTG group) and the final third did not receive any~     soft tissue graft (CTL group).~   "
10329|NCT02922257|"~     This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other~     gene expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated~     kinase 1 [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker~     for use in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or~     surgical treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.~   "
10330|NCT02922244|"~     The herbal products on reduction of radiation-induced dermatitis in patients with breast~     cancer~   "
10331|NCT02922231|"~     Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South~     Korea.~      Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal~     clinical care in South Korea.~   "
10332|NCT02922218|"~     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer~     Treated With Enzalutamide (PROSENZA).~   "
10333|NCT02922205|"~     The purpose of this observational study is to evaluate the safety and performance of the~     Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic~     Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be~     achieved by assessing the device performance and reporting of peri- and postoperative~     complications in a prospectively maintained database.~   "
10334|NCT02922192|"~     Purpose:~      With the existing biologic anti-inflammatory product patents expiring and the FDA approval~     of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic~     (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options.~     This observational study will describe the patient characteristics of new users of Tumor~     Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic~     agents. It will describe in the treatment cohorts outcomes of serious infections that~     require hospitalization. The BBCIC will use the findings from this descriptive analysis to~     design a comparative study evaluating the real-world effectiveness and safety of biosimilar~     and innovator anti-inflammatory biologics.~   "
10335|NCT02922179|"~     Over the past 40 years, new types of insulins have been marketed to mirror the effect of~     endogenous insulin. With the existing long-acting insulin product patents expiring and the~     FDA approval of new biosimilar and innovator insulins, adults with diabetes and their~     physicians will have additional therapeutic options. This observational study will describe~     the patient characteristics of new and existing users of long-acting or intermediate acting~     insulins with and without oral anti-diabetic agents (OAD) as well as acute hypoglycemic~     episodes, acute cardiac events, and A1C measures. The Biologic and Biosimilars Collective~     Intelligence Consortium (BBCIC) will use the findings from this descriptive analysis to~     design a comparative study evaluating the real-world effectiveness and safety of biosimilar~     and innovator insulins.~   "
10336|NCT02922166|"~     To determine the effects of SRX246 on fear and anxiety based on fear-potentiated startle in~     humans. Additionally, the effects of the compound on emotion recognition will be explored.~   "
10337|NCT02922153|"~     The investigators propose to assess whether intra-operative intercostal cryoanalgesia using~     the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior~     post-operative analgesic efficacy as compared to current pain management in patients~     undergoing unilateral thoracotomy cardiac procedures.~   "
10338|NCT02922140|"~     This study aims to investigate the role of clinical pharmacist in the development of a~     pharmaceutical care program for patients with Acute coronary syndrome tailored to their~     specific learning needs and their cultural context, and to verify the program's effects on~     physiological factors and recurrent symptoms or cardiac events.~   "
10339|NCT02922127|"~     Breast cancer accounts for almost a quarter of all cancers in women. In the United States~     (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer.~     There is an urgent need to develop acceptable means of preventing breast cancer both for~     high risk and average risk women.~      The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the~     capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation~     (increase in number of cells in the breast) and to measure its effect compared to that found~     with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use~     as daily medication up to 12 months for the treatment of abnormally heavy bleeding at~     menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its~     use as a daily contraceptive.~      The investigators will use breast biopsies to compare breast cell proliferation, comparing~     biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA~     and COC). The investigators will also compare the changes in the 2 groups to each other. The~     comparison of the effect of UPA to that of a conventional COC is because of UPA's potential~     use as a daily contraceptive.~      Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of~     hormones on the breast are rapid and an anti-progestin such as UPA, which will block the~     action of progesterone in the breast, would be predicted to quickly lower breast cell~     proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied~     and are reassuring. COC use has not been found to lower breast cell proliferation and is not~     associated with any decrease in risk of breast cancer.~      The changes in breast cell proliferation will also be compared to changes seen on breast~     MRI. If the changes are highly correlated future studies will be able to be done without the~     need for breast biopsies.~   "
10340|NCT02922114|"~     Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates~     to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated~     and sensitive tool for joint assessment. Published studies showed US joint abnormalities in~     systemic lupus erythematosus patients with or without joint pain. Nevertheless,~     ultrasonography evaluations were not standardized and no study compared clinical and~     ultrasonography assessments. The objectives were 1) to describe ultrasonography joint~     abnormalities in systemic lupus erythematosus population, 2) to compare clinical and~     ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical~     swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and~     ultrasonography-SLEDAI.~   "
10341|NCT02922101|"~     This study evaluates the addition of a quality improvement toolbox to an online audit and~     feedback intervention in Dutch intensive care units. The toolbox comprises for each quality~     indicator (e.g., percentage of patients per shift whose pain is measured) a list of~     potential bottlenecks in the care process (e.g., staff is unaware of the prevailing~     guidelines for measuring pain every shift), associated recommendations for actions to solve~     mentioned bottlenecks (e.g., organize an educational training session), and supporting~     materials to facilitate implementation of the actions (e.g., a slide show presentation~     discussing the importance and relevance of measuring pain every shift). Half of the~     participating intensive care units will only receive online feedback, while the other half~     will additionally gain access to the integrated toolbox to facilitate planning and executing~     actions.~   "
14068|NCT02873156|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and~     pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.~   "
10347|NCT02922023|"~     In this study, investigators will compare chronotherapy to ABPM. Data collected will include~     hypertension drug therapy regimen prior to and during the study, timing of medication~     administration, and dose, along with the patient's office blood pressure values prior to~     study and one month after modification in therapy. This will enable us to explore whether it~     is a practical endeavor to implement ABPM as a routine process for all uncontrolled~     hypertension patients or whether ABPM does not seem to provide considerable value over~     shifting the timing of drug administration.~   "
10348|NCT02922010|"~     The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral~     hygiene practices of women who participated in a randomized controlled trial (2011001) at~     University of Alabama Birmingham during the period 2012-2014. Additional objectives of the~     research include evaluation of possible cultural, biological or other mechanisms for~     outcomes observed in the OHMOM clinical trial, and oral health screening of children born to~     mothers during the study for the purposes of understanding possible multigenerational~     effects of oral hygiene education.~   "
10349|NCT02921997|"~     This is a single center, randomized, partially-blinded, Phase II, small, targeted,~     prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18~     to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an~     intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without~     AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v~     virus vaccine. The primary objectives include assessing the serum anti-HA~     hemagglutination-inhibition (HAI) response to influenza A, identifying differentially~     expressed genes in human immune cells, and identifying differentially abundant cellular~     proteins in human immune cells.~   "
10350|NCT02921984|"~     The role of postoperative concurrent chemotherapy (CCT) has not been established for~     salivary gland tumors (SGTs). This prospective study was conducted to evaluate the~     feasibility and safety of customized CCT regimens based on the gene targets of SGTs.~   "
10351|NCT02921971|"~     Primary Objective:~      To evaluate, in comparison with placebo, the efficacy of SAR156597 administered~     subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc.~      Secondary Objectives:~        -  To evaluate the efficacy of SAR156597 compared to placebo on physical/functional~          disability in patients with dcSSc.~        -  To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in~          patients with dcSSc.~        -  To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc.~        -  To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of~          SAR156597 in patients with dcSSc.~        -  To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597~          administered subcutaneously for 24 weeks.~   "
10352|NCT02921958|"~     Data was collected from Parents of children who were receiving occupational therapy~     services. Three assessment tools were used: 1. Life Participation for Parents, 2. Infant~     Toddler Sensory Profile, and 3) Child Behavior Checklist. Data was used to pursue 2~     investigations.~        1. Is the Life Participation for Parents responsive to change after intervention?~        2. Are there correlations between child behavior, child sensory processing, and parental~          participation in their own lives while raising a child with special needs.~   "
10353|NCT02921945|"~     In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is~     being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A.~     These subjects will receive open label treatment with SCT800 for approximately 6 months for~     on-demand treatment.~   "
10354|NCT02921932|"~     This study aims to study the efficacy of a preoperative bundle of interventions, which~     consists of preoperative physiotherapy, nutritional support and cognitive exercises on~     elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes.~     There will be two arms, intervention and control.~   "
10355|NCT02921919|"~     This is a single-arm, open-label, extended treatment, safety study in patients treated with~     talazoparib in qualifying studies.~   "
10356|NCT02921906|"~     Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels~     due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a~     DNA region called the KCNJ11 gene. KCNJ11 encodes a channel in the pancreas that acts as a~     switch to turn 'on' and 'off' insulin secretion. A change in KCNJ11 results in a faulty~     channel, which keeps insulin secretion 'switched off'. The diabetes can be treated with~     tablets called sulphonylureas that switch the pancreatic channel 'on', allowing it to~     secrete insulin in response to gut hormones called incretins. Previous research has shown~     that patients who switch from insulin to sulphonylureas have better blood glucose control,~     including fewer episodes of hypoglycaemia (glucose dropping too low), and also avoid the~     need for injections. It is thought that serious side effects from sulphonylureas are~     uncommon in KCNJ11 neonatal diabetes. Some patients report low glucose after meals and we~     think this may be because they make too much insulin if they eat a meal with protein but low~     amounts of carbohydrate. The investigators will test this by giving study participants~     different meals and measuring the amount of insulin, glucose and incretin hormone in the~     blood afterwards.~   "
10357|NCT02921893|"~     This pilot clinical trial studies how well ixazomib citrate, lenalidomide, and dexamethasone~     work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal~     gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving ixazomib citrate, lenalidomide, and dexamethasone may~     work better in treating patients with POEMS syndrome.~   "
10358|NCT02921880|"~     The aim of this pilot study is to assess function, independence, frailty and emotional~     status in 30 patients who have been accepted for TAVI. All patients will attend clinic for~     review at 4 weeks post implant and at that stage, 15 patients will be randomised to~     undertake a cardiac rehabilitation programme and the remaining 15 patients will receive~     standard of care. All patients will return to clinic at 3 months and 6 months post implant~     and undertake the functional, independence, frailty and emotional testing again.~   "
12092|NCT02898896|"~     HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a~     substantial proportion of obstructive CAD. Degree of stenosis is associated with~     immunoactivation (lymphocyte and monocyte) and microbial translocation~   "
10360|NCT02921854|"~     In this exploratory study, the investigators will investigate if markers (molecular and~     immunological) of ICD or anti-tumor immunity (exosomal or molecular) can be detected in the~     serum of patients after high-dose radiotherapy alone or concurrent cisplatin-doublet therapy~     and radiotherapy. For each patient: withdraw blood at three times during treatment for~     analysis.~   "
10361|NCT02921841|"~     Teenagers in mental health treatment are at greater risk for HIV and other sexually~     transmitted infections. This greater risk comes from many factors, some of which are related~     to poor emotion regulation and low self-confidence. There is a need for an HIV prevention~     program specifically for these at-risk teens. The goal of this study is to develop a~     computerized HIV prevention study tailored to adolescents in mental health treatment. The~     first part of the study will develop core sessions of D*STAR. It will do this by using focus~     group feedback from approximately 15 adolescents in mental health treatment, and~     approximately 10 parents of youth in mental health treatment and mental health treatment~     center staff. Feedback on D*STAR prototype sessions will also be collected from two~     individual interviews with approximately 15 youth in mental health treatment. Core sessions~     will then be reviewed in an open trial with approximately 30 adolescents.~      The second part of the study will develop and refine digital versions of the remaining~     sessions of STAR and a digital general health promotion intervention. It will do this by~     using focus group feedback from approximately 20 adolescents in mental health treatment, and~     approximately 10 community advisory board members which include variety of staff from mental~     health treatment settings such as administrators, supervisors, therapists, health teachers~     at therapeutic schools, clinicians at day hospitals and day treatment programs, parents of~     youth in mental health treatment and from relevant community organizations, such as those~     serving lesbian, gay, bisexual, transgender, and questioning youth. Feedback on D*STAR~     prototype sessions will also be collected from two individual interviews with approximately~     20 youth in mental health treatment. All developed sessions (from both Phase I and Phase II)~     will then be reviewed in an open trial with approximately 20 adolescents. A randomized~     control trial (RCT) will then be conducted to compare D*STAR to a time matched digital~     general health promotion intervention among approximately 120 adolescents. For the pilot and~     RCT phases, assessments will be administered prior to randomization, immediately following~     the last intervention session, and at one month post-intervention (pilot study) or at three~     month post-intervention (RCT).~   "
10362|NCT02921828|"~     1. Planned enrollment period One year (The planned number of patients to be enrolled is~          set to 400 patients.) Since all patients who are prescribed with Pomalyst are~          registered in RevMate®, enrollment using the Registration Form of the surveillance will~          be completed at the time when the planned number of patients to be enrolled is reached.~          During a period until conditions for approval are removed, a system enabling to~          retrospectively collect appropriate information based on patient data from RevMate®~          will be, as necessary, maintained.~        2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the~          start date of release of Pomalyst~   "
10363|NCT02921815|"~     To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute~     myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients~     with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter~     referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as~     Revlimid) and who are continuing or no longer continuing Revlimid treatment.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end on the day when the appropriateness of enrollment is assessed for~          all del(5qMDS) patients in the all-case surveillance.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end 3 years after the last enrolled patient begins receiving~          Revlimid.~   "
10364|NCT02921802|"~     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as~     Revlimid) in all patients who are treated with it under the actual condition of use pursuant~     to the conditions of approval.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled is~          reached.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end on the day when the approval condition related to all-case~          surveillance is terminated.~   "
10365|NCT02921789|"~     The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab~     induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC)~     regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the~     prevention of the recurrence of Focal Segmental Glomerulosclerosis (FSGS) as defined by~     nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of~     plasmapheresis and no other evident etiology through 3 months post-transplant.~   "
10366|NCT02921776|"~     This Phase II Small Business Technology Transfer Research (STTR) will deliver a~     comprehensive patient communication solution for communication-impaired patients in the~     intensive care unit that may help decrease days in delirium, decrease anxiety levels, and~     reduce sedation exposure which are proximal outcomes known to be associated with decreased~     mechanical ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare~     cost. The primary goal of this Phase II STTR proposal is to further define user requirements~     and product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad~     communication software, to provide mechanically ventilated (MV) patients an evidence-based~     solution for effectively communicating their needs to care providers and family. A secondary~     goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed~     methods including observations and interaction with hospitalized patients as they use the~     VidaTalk tool, surveys and medical record data extraction, product evaluation and brief~     interview, satisfaction surveys with family members of ICU patients, and focus groups with~     Registered Nurses.~      Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual~     and customizable messages, compatibility with tablet devices, picture symbols, and~     integration with mobile communication devices.~      Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical~     setting.~      Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV~     patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3~     hypothesis: MV patients using VidaTalk will demonstrate significant reductions in~     patient-reported communication difficulty and frustration, anxiety, sedation exposure,~     delirium/coma-free days, and improved patient and family satisfaction with ICU care compared~     to MV patients receiving attention-control (i.e., tablets with health education~     application).~   "
10367|NCT02921763|"~     This survey is intended to collect efficacy and safety data of Duphaston® Tablets in~     patients with endometriosis under actual condition of its use and to obtain data for~     effectively and safely utilizing this drug.~   "
10368|NCT02921750|"~     The investigation is designed as an open, randomized, non-inferiority, multi-centre~     investigation.~      212 subjects will be randomised (subjects lost to follow-up will be replaced). Subjects to~     be included will suffer from an exuding venous or mixed ulcer of predominantly venous~     origin. Subjects will either be randomized to Exufiber® or Aquacel® Extra using centralized~     randomization~   "
10369|NCT02921737|"~     This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to~     evaluate the activity of TAS-102 in previously treated metastatic and locally advanced~     unresectable pancreatic cancer after progression through or intolerance to first line~     chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally~     twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint~     is to determine the progression free survival (PFS) in subjects with unresectable pancreatic~     adenocarcinoma.~   "
12514|NCT02893410|"~     Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential~     thrombocythemia completed an unique paper questionnaire in order to describe their~     observance, the side effects and their own appreciation of the taken drug.~   "
10370|NCT02921724|"~     This is a prospective testing-validation, interventional, non-pharmacological study on a new~     app for oral anticancer therapy management.~      A total of 80 patients will be considered: 20 evaluable patients in the training step; 60~     patients in the validation step. In the training step will be considered evaluable the~     patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment~     performed and questionnaires self-administered.~      Patients will be visited every 6 weeks. In the training step, patients will remain under~     observation for a minimum of 6 weeks, until change of therapy (due to progression of~     disease, unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks.~     Patients enrolled in the validation step will remain under observation until change of~     therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or~     for a maximum of 24 weeks.~      The objective of this study is to assess the capability of a newly developed interactive~     health care application to support patients and health professionals in the shared~     management of oral anticancer therapies, improving adherence, preventing complications at~     home, toxicities, improper treatment reductions or interruptions, emergency accesses and to~     assess the system usability and acceptability by patients and health professionals,~     integration in the hospital workflow, monitoring over time patient perceived levels of~     quality of care, quality of life, social support, anxiety, and self-care capability.~   "
10371|NCT02921711|"~     A prospective, multicenter, observational assessment of the safety and effectiveness of the~     LVIS® device in the treatment of wide necked intracranial aneurysms.~   "
10372|NCT02921698|"~     A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED®~     device in the treatment of intracranial aneurysms.~   "
10373|NCT02921685|"~     This study will determine the Maximal Tolerated Dose if any and the recommended dose for~     phase 2 of monalizumab, a monoclonal antibody directed against the CD94/NKG2A receptor,~     after allogenic stem cell transplantation. All patients will receive one single intravenous~     administration of one of the four doses of monalizumab.~   "
10374|NCT02921672|"~     By doing this study, researchers hope to learn if older adults with and without cognitive~     impairment can adhere to a Mediterranean diet.~   "
10375|NCT02921659|"~     The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide~     Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving~     physiological function (vascular, motor, and cognitive) in healthy middle-aged and older~     adults.~   "
10376|NCT02921646|"~     The purpose of this study is to determine whether evolution of resting energetic expenditure~     is a predictive marker of tumoral response for patients suffering from metastatic pancreatic~     cancer and treated with 1st line of chemotherapy.~   "
10377|NCT02921633|"~     This study will investigate whether behaviourally informed changes to the invitation process~     can improve uptake of childhood influenza vaccine by two and three year olds at primary~     care.~   "
10378|NCT02921620|"~     The study will be a randomized, double blind, placebo-controlled study of the safety and~     efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45~     years. Patients must have diarrhea defined as ≥ 3 stools a day with an average consistency~     of ≥ 5.5 on the Bristol Stool Form Scale (BSFS) by patient electronic diary and moderate to~     severe gastrointestinal symptoms as defined by the Irritable Bowel Symptom Severity Score~     (IBSSS) Part 1 average > 175 derived from at least two IBSSS assessments during screening~     period. Patients will receive intravenous infusions of PRX-102 1 mg/kg or placebo every two~     weeks for 6 months.~   "
10379|NCT02921607|"~     The goal is to define a set of clinical pathways for heart failure patients, reflecting the~     period from prior to admission to the post-discharge period following hospitalisation, under~     the current system that exists at the two clinical sites [as mentioned previously, the main~     site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the~     project team will also carry out similar work Portsmouth Hospital, United Kingdom]. These~     pathways have been drawn up using the experience of the clinical investigators, using an~     interactive workshop approach and a pilot study.~        1. Pre-Admission Pathway~        2. Emergency Department Pathway~        3. In-Hospital management Pathway~        4. Pre-discharge Pathway~        5. Post-Discharge Pathway~      During identification of these pathways, the research team identified the settings/personnel~     that require study to more fully comprehend the methods, strengths and weaknesses of the~     present processes. Study activities are focused on two aspects of the patient journey,~     immediately before discharge and three months post discharge during the outpatient phase.~   "
10380|NCT02921594|"~     Primary: The primary objective of this pilot study is to compare the intraarticular~     kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.~      Secondary: The secondary objective of this pilot study is to compare the standing balance by~     force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR~     prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both~     groups.~   "
10381|NCT02921360|"~     The aim of this study is to determine whether early administration of aspirin in acute~     ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes~     due to decreasing the number of early rethromboses.~   "
10382|NCT02921347|"~     The aim of this study is to facilitate weaning by switching between invasive and noninvasive~     ventilation in difficult-weaning patients.~   "
10383|NCT02921334|"~     The aim of this study is early tracheotomy to facilitate weaning by switching between~     invasive and noninvasive ventilation.~   "
10384|NCT02921321|"~     Muscular Dystrophy can affect the skeletal muscles and also the heart and breathing muscles,~     causing significant morbidity and mortality. As patients are now living longer, treatment of~     muscular dystrophies involves drugs that help improve heart function. However, better types~     of heart imaging studies are needed to understand how these treatments work. Researchers~     want to improve heart imaging to identify earlier indicators of heart dysfunction in~     muscular dystrophy patients and how these are changed by medical treatment. The new imaging~     indicators will also help identify candidates for entry into future clinical trials.~   "
10396|NCT02921165|"~     The aim of this study is to determine the beneficial effect of mouth rinses, both topical~     analgesic and saline regimens as an adjuvant therapy in the presence of standard~     prescription of post-operative pain killers on the progress of socket healing following~     routine dental extraction.~   "
10385|NCT02921308|"~     Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common~     complication of being born premature. Damage to the still developing lung stops the normal~     formation of the alveoli. Young adults with a history of BPD have lower lung function, early~     heart disease, and increased risk of death, compared to those without BPD. Recently, it has~     been reported that they may also develop a type of lung disease typically seen in older~     adults with a longstanding history of smoking. The severity of lung disease is usually~     measured using pulmonary function tests (PFT), but these tests may be normal, even in the~     presence of important changes in the fine structure of the lung. Such structural changes may~     be early markers of future lung disease and can be detected using lung magnetic resonance~     imaging (MRI). Unlike other ways of imaging the lungs, MRI does not expose people to harmful~     X-rays. To date, no studies have been done to examine the fine structure of the lung of~     school-aged children who had a history of BPD, to determine whether there are signs of lung~     disease that might not otherwise be obvious. This is important because once armed with this~     information, preventive measures can be taken to avoid worsening of lung disease.~      Objective: 1) In 7-9 year-old children born extremely premature, lung MRI will be compared~     between those with and without BPD. The Investigators expect to observe more severe~     structural lung abnormalities in children with BPD, compared to those without BPD; 2) The~     Investigators will test to see if children with more severe MRI abnormalities also have~     worse lung function, and/or more symptoms of breathing problems. The Investigators expect to~     observe more PFT abnormalities in children with BPD than in those without and that these~     will match up with lung fine structure abnormalities identified on MRI.~      How will work be undertaken? Children 7-9 years old who were born extremely prematurely will~     be recruited to participate in this study. Participants will be identified from Neonatal~     Follow-up clinics they attended. The Investigators will enroll 20 children with BPD and 20~     without BPD. Participants will have lung MR images taken, during which they need to lie~     still for a few minutes. PFT will also be performed, during which they will blow into a~     machine. Parents will be asked to complete questionnaires about breathing problems, their~     living conditions (environment) and any doctor visits or hospital stays. Medical charts will~     be reviewed for information about their birth.~      Unique/Innovative Aspects: This will be the first study using MRI as an innovative way to~     visualize and measure fine structure of the lung in children born prematurely with and~     without BPD. These findings may be early markers of lung disease, which would identify~     children who have, or are at risk of developing lung disease later in life, for whom the~     Investigators may be able to offer treatments now and/or prevent worsening of lung disease.~   "
10386|NCT02921295|"~     The purpose of this study is to compare the College Park Sidekicks to conventional stubby~     prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity,~     exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will~     be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to~     complete the 10-meter walk test will be decreased wearing Sidekicks compared to the~     conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the~     sidekicks.~   "
10387|NCT02921282|"~     In this study, potential associations between several genetic polymorphisms and nicotine~     dependence will be examined. The relative reinforcing efficacy of cigarettes using the~     forced-choice procedure will be assessed. In addition, reactivity to smoking cues using a~     reliable procedure will be conducted.~   "
10388|NCT02921269|"~     This phase II trial studies how well atezolizumab and bevacizumab work in treating patients~     with cervical cancer that has come back, remains despite treatment, or has spread to other~     places in the body. Monoclonal antibodies, such as atezolizumab and bevacizumab, may shrink~     tumor cell and interfere with the ability of tumor cells to grow and spread.~   "
10389|NCT02921256|"~     This randomized phase II trial studies how well veliparib works with combination~     chemotherapy and radiation therapy in treating patients with rectal cancer that has spread~     from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells~     and shrink tumors. Giving veliparib with combination chemotherapy and radiation therapy may~     kill more tumor cells and giving it before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~   "
10390|NCT02921243|"~     In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or~     schizoaffective disorder, investigators propose to conduct a prospective, 2 week~     observational trial to collect gastrointestinal stool samples in order to characterize the~     microbiota in people with schizophrenia and examine its variability over time. Participants~     may elect to participate for an additional two weeks, during which they will receive the~     prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the~     relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators~     will use an inpatient sample in order to standardize meals, exercise and environmental~     mediators. This is considered a feasibility, pilot study in order to apply for future grant~     funding. Investigators will recruit patients from the Treatment Research Program inpatient~     unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.~   "
10391|NCT02921230|"~     The EMINENT study is a prospective, multi-center study confirming the superior effectiveness~     of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in~     the femoropopliteal arteries.~   "
10392|NCT02921217|"~     The study's main objective is to investigate if an extract containing the probiotic~     Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the~     accumulation of abdominal visceral fat in people with abdominal obesity.~   "
10393|NCT02921204|"~     Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia.~     Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are~     thought to be at greater risk for vitamin D deficiency because of their darker skin type and~     the likelihood of reduced ultraviolet exposure . The present study entitled, Dietary Intake~     and Vitamin D Level in adult Women, was formulated as there is paucity of data on the~     etiologic importance of dietary intake in Vitamin D level on blood on women. The major~     objective of the proposed study is to assess the effect of dietary intake of nutrients and~     level of vitamin D in women .~   "
10394|NCT02921191|"~     Purpose:~      With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents~     expiring and the FDA approval of new biosimilar and innovator biologics, patients being~     treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional~     therapeutic options. This observational study will describe the patient characteristics of~     new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of~     hospitalizations for febrile neutropenia. The BBCIC will use the findings from this~     descriptive analysis to design a comparative study evaluating the real-world effectiveness~     and safety of biosimilar and innovator G-CSFs.~   "
10395|NCT02921178|"~     The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in~     the propensity-matched group on asthma exacerbation in asthma patients in Korea: a~     retrospective cohort in real world.~      Omalizumab was approved 2007 in Korea and has been used in this center. We would like to~     collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no~     Korean real world data available.~   "
10397|NCT02921152|"~     Operable early stage breast cancer patients staged according to NCCN guidelines are~     subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation~     under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and~     the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated~     tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will~     be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively.~     Results of the pilot study will be evaluated as observational study.~   "
10398|NCT02921139|"~     Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in~     treating hepatocellular carcinoma patients with unresectable intermediate stage. However,~     residual viable HCC after TACE is not uncommon, leading to a poor overall survival after~     TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be~     potentially useful for curatively managing early-stage HCC in retrospective studies. Thus,~     conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE~     residual tumors is therefore encouraged. The present phase-III trial intended to compare~     clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with~     post-prior-TACE residual tumors.~   "
10399|NCT02921126|"~     To quantify rates of bleeding events and investigate the characteristics of prescribed~     patients, rates of bleeding events, persistence and healthcare resource utilization of Oral~     Anticoagulants (OACs) prescribed in routine clinical practice.~   "
10400|NCT02921113|"~     Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump~     cardiac surgery. End stage kidney failure requiring dialysis therapy after cardiac surgery~     is associated with more than 60% mortality rate. Involvement of AKI after on-pump cardiac~     surgery increases the mortality rate 19 times. suPAR is one of the novel biomarker which has~     potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac~     surgery. Early diagnosis and prompt intervention to prevent AKI has great importance for~     management of postoperative cardiac patients.~   "
10401|NCT02921100|"~     150 patients who had suspected pancreatic malignancy were planed to be enrolled in this~     study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital~     image analysis and conventional cytology respectively. The investigators aim to compare the~     efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the~     investigators also collected the blood sample of each enrolled patient for advanced study.~   "
10402|NCT02921087|"~     This study seeks to address whether or not different types of daily disposable soft contact~     lenses may be a beneficial option for patients complaining of eye strain and visual~     discomfort while using digital devices.~   "
10403|NCT02921074|"~     This study is a validation study to document the acceptability of the Tonic and Phasic~     Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia.~     The goal of this study is to employ a computerized attention-training program, TAPAT,~     designed for chronic late-life insomnia in a randomized, controlled trial to assess~     feasibility and initial efficacy in this population.~   "
10404|NCT02921061|"~     This randomized phase I trial studies the side effects and best dose of decitabine when~     given together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in~     treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly~     diagnosed, has come back, or has not responded to treatment. Drugs used in chemotherapy,~     such as decitabine, cladribine, cytarabine, and mitoxantrone hydrochloride work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Colony-stimulating factors, such as~     filgrastim, may increase the production of blood cells and may help the immune system~     recover from the side effects of chemotherapy. Decitabine, filgrastim, cladribine,~     cytarabine, and mitoxantrone hydrochloride may work better in treating patients with acute~     myeloid leukemia and myelodysplastic syndrome.~   "
10405|NCT02921048|"~     This observational study recruits healthy individuals who have been routinely taking high~     amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid~     (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating~     the cardiopulmonary effects of exposure to ambient air pollution.~   "
10406|NCT02921035|"~     This is an open label, non randomized, uncontrolled, multicenter, single arm observational~     study. In this study, the enrolled subjects will be treated with Rebif human serum albumin~     (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc),~     thrice in a week (tiw) for 24 months.~   "
10407|NCT02921022|"~     The purpose of this study is to test any good and bad effects of the study drug called~     PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA)~     has not approved the marketing or sale of PEGPH20, but have authorized its use in research~     studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects.~     PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced~     by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of~     hyaluronan from tumors may decrease tumor growth.~   "
10408|NCT02921009|"~     This study will investigate the effectiveness of fluence rates and treatment times of~     Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.~   "
10409|NCT02920996|"~     This research study is examining merestinib (a targeted therapy) as a possible treatment for~     non-small cell lung cancer (NSCLC) that was found to have a specific change in the MET gene~     (a MET exon 14 mutation); or as a treatment for solid tumors that have an alteration in the~     NTRK gene (an NTRK1, 2, or 3 rearrangement).~   "
10410|NCT02920983|"~     This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and~     omafilcon A II 2 daily disposable contact lenses.~   "
10411|NCT02920970|"~     This study aims to compare the clinical performance and subjective acceptance of the~     narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable~     basis.~   "
10412|NCT02920957|"~     The aim of this study is to determine the clinical performance of comfilcon A in comparison~     to senofilcon C.~   "
10413|NCT02920944|"~     This study aims to examine technical feasibility and diagnostic yield of new 20-gauge~     Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge~     Procore needle. The study design is prospective, randomized study.~   "
10415|NCT02920918|"~     Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs~     Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption~     [VO2]) and ventilator efficiency (minute ventilation [VE]/carbon dioxide production [VCO2]~     slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary~     endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and~     diet will be also measured (secondary endpoints).~   "
10416|NCT02920905|"~     The present clinical study will be undertaken to compare study between the effect of~     atracurium with lidocaine versus addition of magnesium sulphate to the same doses with~     lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block,~     sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and~     surgeon satisfaction .~   "
10417|NCT02920892|"~     The overall goals are to change the paradigm for development of mechanism targeted~     pharmacotherapy in neurodevelopmental disorders and provide a definitive test of the mGluR~     theory in humans by determining whether AFQ056, an mGluR5 negative modulator, can enhance~     neural plasticity in the form of language learning during an intensive language intervention~     in very young children with fragile X syndrome. This trial therefore will use an innovative~     but exploratory new trial design to develop a different way to examine efficacy of an agent~     with substantial support as a drug targeting CNS plasticity in preclinical models of a~     developmental disorder. If the design is successful, this trial can serve as a model for~     future trials of mechanistically-targeted treatments operating on neural plasticity in other~     neurodevelopmental disorders.~   "
10418|NCT02920879|"~     This study investigates airway effects of PEEP during maskventilation at anesthesia~     induction. Four patient groups will be ventilated with different PEEP and driving pressures~     to evaluate time to open airway after start of positive pressure maskventilation during~     anesthesia induction.~   "
10419|NCT02920866|"~     This study plans to learn more about the effects of physical therapy (PT) following a total~     hip arthroplasty (THA). The purpose of this study is to compare standard of care PT after~     THA with a physical therapy program specifically designed to integrate targeted core and hip~     muscle strength and functional training.~   "
10420|NCT02920853|"~     The purpose of this study is to assess whether a novel, enhanced form of biofeedback can~     help individuals regulate their chronic musculoskeletal pain more effectively.~   "
10421|NCT02920840|"~     Combining TMS and EEG, this study investigates a personalized therapeutic non-invasive brain~     stimulation protocol in patients with major depression, whereby the timing of the TMS pulses~     is synchronized with the instantaneous phase of ongoing brain oscillations in order to~     modulate the inter-hemispheric left and right dorso-lateral prefrontal cortical brain~     network.~   "
10422|NCT02920827|"~     The proposed study is a single center, double-blind placebo-controlled trial to assess the~     safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted~     for 28 days in 16 healthy, HIV-negative women.~   "
10423|NCT02920814|"~     The aims of this project are to determine the effectiveness of a time intensive form of~     Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research~     shows that this brief format can be effective in other specific phobias e.g. insects and~     animals. However, to date limited research has been conducted on the effectiveness of time~     intensive forms of CBT for SPOV. A single case experimental design will be used to analyse~     specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for~     Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore~     the effectiveness of CBT delivered in a time-intensive format and imagery rescripting~     elements of the treatment. This initial study will provide important information about which~     elements of CBT are most effective at reducing targeted symptoms and whether symptom~     reduction can be achieved in a shorter number of sessions. It represents a crucial step~     before this format of CBT can be more rigorously evaluated and compared to other treatment~     approaches by Randomised Controlled Trial.~   "
10424|NCT02920801|"~     In this study, the investigators aim to investigate whether saxagliptin modulate endothelial~     progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type~     2 diabetic patients.~   "
10425|NCT02920788|"~     One of the most pressing concerns within the VA currently is the provision of interventions~     that address the cognitive as well as emotional problems faced by Veterans with mild TBI and~     comorbid conditions. When completed, these studies will inform us whether training core~     attentional self-regulatory control functions via personally-relevant activities will be~     effective in improving daily life for Veterans with mild TBI and comorbid conditions. The~     study design will provide a test not only of potential benefits for real life functioning,~     but also determine to what extent these benefits are related to actual changes in~     cognitive/behavioral performance and brain networks corresponding to these functions. This~     project will provide a foundation for future studies to investigate the neural mechanisms~     that support improvements of cognition and behavior in mTBI.~   "
10426|NCT02920775|"~     Changes in prescribing will be compared in prescribers from specialties whose prescribing is~     hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice~     providers) versus those for whom the REMS could have greater impact on prescribing (e.g.,~     dentists). Trends and changes in monthly prescription volume and average monthly~     prescription volume will be evaluated by prescriber specialty.~   "
10427|NCT02920762|"~     A study will be performed to evaluate changes in prescribing behavior of prescribers of~     ER/LA opioids~   "
10428|NCT02920749|"~     The purpose of this study is to compare the perioperative hemodynamic parameters, recovery~     profiles and cost containment of sevoflurane and propofol based general anesthesia for~     otorhinolaryngeal surgery.~   "
10429|NCT02920736|"~     The purpose of this study is to determine the value of urine sTREM-1 on early predicting~     secondary acute kidney injury in sepsis~   "
10430|NCT02920723|"~     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It~     does multiply tenfold the occurrence of vascular events, particularly stroke. While~     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to~     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term~     adherence to CPAP is a significant problem and search for alternative treatment is~     essential.~   "
10432|NCT02920697|"~     The purpose of this study is to determine the safety profile and tolerability of S 55746 in~     patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum~     Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety~     profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.~   "
10433|NCT02920684|"~     Despite several positive studies, benefits of early rehabilitation on recovery and motor~     performance improvement need to be demonstrate. A recent study finds that despite early~     rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises~     applied in intensive care is common and most patients stay in bed.~      Under these conditions, the optimal choice of the rehabilitation technique for bedridden~     patient and its intensity should be studied.~      The objective of the study is to evaluate the cardiovascular and metabolic response of~     patients during four interventions: Passive legs mobilization, Passive cycloergometter,~     Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.~   "
10434|NCT02920671|"~     Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a~     confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both~     obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive)~     without a family history of mitochondrial disease to compare to affected individuals.~      The study involves non-invasive MRI methods and glucose tests to focus on the relationship~     between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures~     will be completed within 2 days, which includes an overnight stay at the Hospital of the~     University of Pennsylvania. There are no study medications or sedations, and participants~     will be continually monitored during minimally-invasive procedures (e.g., blood draws).~      All participants will be able to receive compensation. Furthermore, it may be possible to~     provide reimbursement for travel, lodging, and meals for individuals with mitochondrial~     disease.~      Investigators hope that this research will contribute to the current knowledge of~     mitochondrial disease and that it will improve diagnostic and treatment approaches.~   "
10435|NCT02920658|"~     This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral~     lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP~     and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will~     receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS~     could be efficient in the treatment of OLP and RAS, with effects comparable to that of~     topical steroids.~   "
10436|NCT02920645|"~     The primary objective of this multicenter study is to validate the AVICH score in terms of~     patient outcome prediction in AVM patients with associated ICH.~      Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is~     measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2)~     and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters,~     which are part of the AVICH score, will be compared between the 2 groups: ICH score~     including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of~     intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade~     including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young~     grade, including age, presence of ruptured AVM, and the nidus structure. In addition~     pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no~     treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be~     compared.~      Multicentre validation study~      Key inclusion criteria:~        -  All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before~          hemorrhage~        -  Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion~          criteria.~      Key exclusion criteria:~        -  incomplete data set~        -  AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH~   "
10437|NCT02920632|"~     This study evaluates the efficacy of an eight-week online cognitive training program on~     objective and subjective cognitive functions in Parkinson's disease. Moreover, we intend to~     map the effect on brain network function, and if cognitive training can prevent the~     development of PD-MCI/PD-D after one-year follow-up. In this study, two training groups will~     be compared (N: 60 vs 60). In half of the participants MRI and magnetoencephalography (MEG)~     will be assessed (N: 30 vs. 30). We expect cognitive training to improve cognitive~     functions, and to improve the efficiency of brain network function. Moreover, we expect that~     cognitive training can decrease the risk of PD-MCI/PD-D at one-year follow-up.~   "
10438|NCT02920619|"~     The purpose of this study is to develop computational methods for cross-comparison of muscle~     composition measurements in three laboratory ultrasound systems.~   "
10439|NCT02920606|"~     The procedure currently recommended for the treatment of irreversible pulpitis is the~     endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation~     of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at~     an ulterior appointment by the root canal treatment. The purpose of the present pilot study~     is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in~     mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a~     tricalcium silicate cement will be directly applied on the remaining pulp at the root canal~     entrances. A short-term follow-up will be performed at one week by evaluating the pain~     relief of the patient. Long-term success will then be evaluated every year by verifying the~     absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms~     and signs. A standard root canal procedure will serve as control.~   "
10440|NCT02920593|"~     The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the~     incidence of hypertensive disorders of pregnancy.~   "
10441|NCT02920580|"~     This randomized controlled trial will enrol patients with acute severe brain injury who pass~     a spontaneous breathing trial but have decreased level of consciousness. It will directly~     compare (1) prompt extubation vs. (2) prompt tracheostomy vs. (3) usual care, with~     extubation or tracheostomy timed according to physicians' discretion. The primary outcome~     will be ICU free days (days spent alive and outside an ICU).~   "
10517|NCT02919592|"~     The purpose of this study is to collect additional post-approval clinical data on the~     long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary~     or revisional breast augmentation and primary or revisional breast reconstruction.~   "
12515|NCT02893397|"~     The goal of this clinical research study is to learn if regular exercise is possible for~     children and young adults with bone cancer who are having chemotherapy.~   "
10442|NCT02920567|"~     This study aims to examine whether octreotide has an effect on inhibition of the exocrine~     secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula~     after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for~     periampullary tumors were enrolled. The patients were randomly assigned to intervention (use~     of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7~     days. Every patients will undergo pancreaticojejunostomy with external stent for remnant~     pancreas management. The pancreatic juice is drained through the external stent by negative~     pressure and amounted.~      Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary~     endpoint was the rate of pancreatic fistula.~   "
10443|NCT02920554|"~     The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to~     4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates~     between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder~     cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3~     gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are~     randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each~     group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.~   "
10444|NCT02920541|"~     The purpose of this study is to determine the safety profile and tolerability of S 055746 in~     patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities~     (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D)~     through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.~   "
10445|NCT02920528|"~     This is a prospective, randomized controlled trial which will be conducted to determine~     whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with~     chronic pain syndrome presenting to the emergency department with exacerbation of their~     chronic pain. The investigators also aim to determine whether use of SDDK can reduce the~     amount of subsequent opioid pain medications required for adequate pain relief in this~     population.~   "
10446|NCT02920515|"~     This is a prospective, multicentric, comparative, non-randomized interventional study in~     which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were~     treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.~   "
10447|NCT02920502|"~     Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D~     (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency~     over the last few years is to give higher, less frequent doses. Disease-specific dosing is~     of interest, and there may be optimal serum concentration targets based on disease process.~     The best evidence so far is for optimal bone health, where most experts agree that 25OHD~     serum concentration should be above 30 ng/ml.~      There is mounting evidence that Vitamin D therapy will reduce inflammatory response and~     macrophage activation. The optimal dosing needed to decrease the inflammatory response is~     unclear, although our recent mouse model has demonstrated that a onetime high dose is~     effective. The investigators therefore hypothesize that a one-time high dose of~     cholecalciferol will be effective in suppression of macrophage production of tumor necrosis~     factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot~     study is to assess the optimum dosage for the most macrophage suppression.~   "
10448|NCT02920489|"~     Neuraxial analgesia is the gold standard to relieve labor pain. A recent Practice~     guidelines for obstetric anesthesia suggests that neuraxial analgesia should be provided in~     the early stage of labor (cervical dilation < 5 cm) or on a individualized basis. The~     purpose of this randomized controlled trial is to investigate whether neuraxial labor~     analgesia administered on an individualized basis can improve analgesia quality and maternal~     satisfaction.~   "
10449|NCT02920476|"~     This is a non-randomized, open label, sequentially enrolling phase II study with a Simon~     two-step enrollment design to evaluate the activity of TAS-102 in previously treated~     unresectable or metastatic squamous non-small cell cancer after progression through or~     intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered~     orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine~     the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of~     unresectable or metastatic recurrent squamous non-small cell lung cancers.~   "
10450|NCT02920463|"~     DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a~     multicenter, international, prospective, observational cohort study, aiming to describe the~     rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy~     for infections at the intensive care unit.~   "
10451|NCT02920450|"~     The purpose of this research study is to determine if the study drug, Gedatolisib~     (PF-05212384), given in combination with paclitaxel and carboplatin will work against~     unresectable non-small cell lung cancer.~   "
10452|NCT02920437|"~     A pilot randomized controlled trial will be conducted to investigate the feasibility and~     effectiveness of a salt intake reduction intervention to young hypertension patients in Hong~     Kong who had high salt intake.~   "
10453|NCT02920424|"~     The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following~     multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus~     Erythematosus (SLE) and to determine whether premedication with corticosteroids is required~     to improve the tolerability of SC JNJ-56022473.~   "
10454|NCT02920411|"~     The purpose of this study is to determine the effectiveness of a combined dermatological~     treatment in children up to 5 years old with mild or moderated atopic dermatitis.~   "
10455|NCT02920398|"~     Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the~     pivotal process and turoctocog alfa pegol from the commercial process in patients with~     severe haemophilia A~   "
10456|NCT02920385|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of~     levothyroxine and the influence of co-administered tablets on the pharmacokinetics of~     semaglutide administered orally in healthy subjects.~   "
10457|NCT02920372|"~     The study consists of generation of biological samples (in blood and urine) positive to~     Epoetin alfa for laboratories that wish to perform the analysis of doping controls and~     maintain accreditation from World Anti-Doping Agency.~   "
10460|NCT02920333|"~     This study is to compare the efficacy of two types of non-invasive brain stimulation (NIBS)~     in lower limb motor function recovery in stroke patients. The intervention will be tDCS~     (transcraniel direct current stimulation) or rTMS (repetitive transcraniel magnetic~     stimulation) plus conventional gait training for 10 days over 2 weeks.~      The study hypothesizes that:~        1. When combined with conventional gait training, NIBS could improve the walking ability~          of stroke survivors.~        2. NIBS will modulate cortex activity of the brain area representing the lower limbs.~        3. The effects of NIBS might be related to some genetic factors. 45 subjects will be~          randomly divided into 3 groups, receiving tDCS plus conventional gait training, or rTMS~          plus conventional gait training, or sham tDCS plus conventional gait training.~      The outcome measures include clinical functional assessment, brain activity assessed by TMS~     measurement and MRI, genetic factor measurement. All these will be done at pre, immediate~     after intervention and 4 weeks after intervention.~   "
10461|NCT02920320|"~     In this study, people who suffer from strong self-critical tendencies will be randomized to~     two study conditions. The first group receives an account to an internet-based self-help~     intervention. The second group is a waiting control group. In both conditions additional~     care or treatment is allowed. The aim of the study is to investigate the effectiveness of an~     internet-based self-help intervention on depressive, anxiety and stress symptoms compared to~     a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8~     weeks, participants in the waiting control group get also access to the intervention and~     fill out questionnaires after 8 weeks again.~   "
10462|NCT02920307|"~     Although mesh fixation has been associated to an increased incidence of nerve injury and~     involves increased operative costs, many surgeons feel that fixation is necessary to reduce~     the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of~     laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.~   "
10463|NCT02920294|"~     To determine the small intestinal microbiota response in humans to dietary interventions for~     two consecutive weeks, and to relate this to parameters of intestinal barrier function and~     immune and metabolic responses in blood, as functional outcome parameters of host physiology~   "
10464|NCT02920281|"~     The aim of the study is to evaluate the impact of sleep quality on the length of mechanical~     ventilation weaning, in intensive care unit patients~   "
10465|NCT02920268|"~     Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These~     problems results in decreased quality-of-life, absence from school, lower sleep quality and~     increased health-care consumption. Long-term effects are lasting pain-symptoms and increased~     risk for psychiatric illness.~      The scientific evidence for interventions towards long-term pain in children is limited and~     pharmacological treatment is not effective. Cognitive behavioral therapy has shown some~     effect but is time- and resource consuming. Dance and yoga can enhance positive protective~     factors through better body awareness and increased self-regulation. Relaxation in yoga also~     has positive effect on abdominal pain.~      The aim of this study is to evaluate the effects of an intervention with dance and yoga for~     girls, 9 to 12 years old, with recurrent abdominal pain. The participants will be identified~     through pediatric clinics in Örebro County, primary health care and school health care. They~     will be randomized to intervention with weekly dance- and yoga class for 8 months or control~     group with standard treatment. Primary outcome is the fraction of girls in each group who,~     direct after intervention, has decreased their maximum pain measured by Faces Pain Scale.~     Secondary outcomes are stress, psychical health, well-being, school and sleep functions,~     physical activity and health-economy. The study group will be followed up for two years.~      Just-in-TIME is an interdisciplinary research group with expertise in interventions for~     psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify,~     Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal~     pain through an intervention with dance and yoga for 9-12 year old girls.~   "
10466|NCT02920255|"~     The objective is to compare the accuracy and reproducibility of measurements taken with~     electronic calipers and conventional calipers. Using both calipers, reproducibility will be~     determined by comparing results from a number of practitioners and accuracy will be~     determined by comparing results with those obtained from X-rays.~   "
10467|NCT02920242|"~     This study will compare safety and efficacy of a generic rifaximin tablet to the reference~     listed drug in the treatment of travelers' diarrhea. Additionally both the generic and~     reference formulations will be tested for superiority against a placebo tablet.~   "
10468|NCT02920229|"~     Single-center, prospective, diagnostic trial in radically treated patients with biochemical~     recurrence of prostate cancer. Patients with radically treated prostate cancer with~     biochemical relapse and negativity of all traditional morphological and functional imaging~     (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of~     2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68~     (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography~     (PET)/Computed Tomography (CT) scan.~   "
10469|NCT02920216|"~     Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when~     organ has to be preserved or when surgery is not indicated. The loco-regional failure is~     about 30%. Then salvage surgery is the only chance for patients to survive but the overall~     survival rate is only 29% at 24 months. This prognostic is bad because of poor local control~     which is non-optimized by a complementary radiotherapy and negative exeresis margins.~      Currently, there is no intraoperative technique to better visualize the tumor limits in real~     time. With fluorescence techniques, an accurate mapping of tumor extension can be~     considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a~     head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et~     al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously~     in salvage surgery for patient with head and neck cancer.~      The ability of ICG to detect a surgical margin positive intraoperatively has never be~     evaluated in irradiated area.~      The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery~     for recurrence of head and neck cancer in irradiated area.~   "
10470|NCT02920203|"~     The purpose of the study is to better identify hereditary cardiac causes of sudden~     unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue~   "
10471|NCT02920190|"~     Background~      Antigen-driven selection has been implicated in the pathogenesis of monoclonal gammopathies.~     Patients with Gaucher's disease have an increased risk of monoclonal gammopathies and~     symptomatic myeloma. Clonal immunoglobulin in patients with Gaucher's disease and in mouse~     models of Gaucher's disease-associated gammopathy are reactive against lyso-glucosylceramide~     (LGL1), which is markedly elevated in these patients and mice. A recent report indicates~     that clonal immunoglobulins in 33% of sporadic human monoclonal gammopathies may also be~     specific for the lysolipids LGL1 and lysophosphatidylcholine. Substrate reduction~     ameliorates Gaucher's disease-associated gammopathy in mice. This principle (that antigen~     removal can induce tumor regression) has been proven in other hematologic malignancies,~     where H. Pylori eradication causes lymphoma regression is a significant group of patients.~     Thus, as longterm immune activation by lysolipids may underlie both Gaucher's~     disease-associated gammopathies and some sporadic monoclonal gammopathies, this may~     represent a focus for treatment.~      Epicardial fat (EAT), the visceral fat of the heart, is highly enriched in genes involved in~     inflammation and lipid metabolism; it activates local and systemic inflammation and innate~     inflammatory response. EAT is rich in saturated fatty acids and has high protein content,~     and the greatest capacity for free fatty acids release and uptake among any other visceral~     fat depots. Of interest, EAT is highly enriched in sphingolipids, including ceramide. EAT~     clinical measurability with an ultrasound technique, first developed and validated by~     Iacobellis, and its rapid responsiveness and reduction to medications targeting the visceral~     fat, such as the glucagon-like peptide 1 analogues (GLP1A), as ongoing clinical trials are~     demonstrating, is of growing and remarkable interest.~      Study Hypothesis~      To target EAT, as marker of visceral fat, with GLP1A treatment to modulate/reduce/remove the~     antigen(s) (lipid/inflammatory/immune) stimulation for patients with monoclonal gammopathies~     that are lipid targeted.~      Study Design~      Interventional, single-group, open label pilot study. The investigators will identify~     monoclonal gammopathy patients whose antibodies are lipid/visceral fat targeted (goal is 10~     initially as a pilot) and who are overweight/obese (BMI > 27). Eligible patients will be~     started on Liraglutide up to 1.8 mg sc once daily, as adjunct weight loss treatment for 12~     months.~      Study Endpoints~        -  Ultrasound measured EAT reduction by at least 20%~        -  Improvement in the monoclonal immunoglobulin profile Reduction in plasma ceramide and~          lipidomics levels~      Parameters will be monitored at 3 months, 6 months and 12 months.~   "
10472|NCT02920177|"~     The purpose of this study is to compare the clinical response of intra-articular platelet~     rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular~     impingement (FAI).~   "
10473|NCT02920164|"~     Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized~     crossover study on healthy volunteers~      Study period: 04/2012 - 07/2012~      Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of~     Greifswald~      Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in~     comparison to placebo acupuncture and no intervention during oral exams in anatomy at the~     University of Greifswald~      Design: Prospective blinded randomized crossover trial~      Intervention:~        1. AA using indwelling fixed needles, retained 24 h in situ~        2. AA using placebo needles~      Number of volunteers: N = 40~      Outcome measures: Anxiety level, Heart rate, blood pressure.~   "
10474|NCT02920151|"~     This study evaluates the effect of balance circuit in patients with more than one year of~     postoperative total hip or knee arthroplasty. Patients were randomized between intervention~     group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The~     evaluations were conducted by blind examiners.~   "
10475|NCT02920138|"~     Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive~     end expiratory pressure (5PEEP) on serebral oxymeter levels in morbid obese patients whose~     undergoing laporoscopic sleewe gastrectomy. Second outcome is to investigate the effect of~     IAP changes on cerebral oxygen values in LSG.~      Method:18-65 yo, ASA2-3 status, 60 MO patients which planned SLG under general anesthesia~     were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic~     instability during procedure. Patients were divided into 2 groups which was ventilated with~     no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were~     use right hand dominant. Near infrared spectroscopy probes were applied to both frontal~     cerebral area of all patiens and measured rSO2 values. IAP were measured transvesically in~     all groups. Datas were recorded as basal, after induction of anesthesia, 5 minute before~     insuflation(5BI), 5 minute after insuflation(5BA), 15, 30, 45, 60 minute after induction, 5~     minute before desuflation(5BD) and 5 minute after desuflation(5AD) time periods. Invasive~     arterial pressures, serebral oxymeter values, 5 lead electrocardiography, peripheral oxygen~     saturation, end tidal carbondioxide, peak inspiratory pressures, IAP, were recorded time~     periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.~   "
10476|NCT02920125|"~     To evaluate the benefits of Ayurvedic SUVED & REIMMUGEN Colostrum for reduction/reversal of~     symptoms and study clinical progress in Vascular disease; CAD, CAV, Stroke, DVT patients.~   "
10477|NCT02920112|"~     This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility~     of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to~     the usual standard of care in bariatric surgery patients. Participants one year post-surgery~     will receive six sessions of Tele-CBT and complete measures before, during, immediately~     after, and one year after participation in the study.~   "
10478|NCT02920099|"~     The purpose of this study is to develop a tool to help researchers better understand what~     diet information people know and what skills they use to make diet choices.~   "
10479|NCT02920086|"~     The purpose of this study is to improve the outcomes of critically ill older patients and~     the health outcomes of their families by capacitating and partnering with families in~     optimizing patient/family centered care.~   "
10480|NCT02920073|"~     The objective of this trial is to evaluate gut microbiota changes in undernourished patients~     with anorexia nervosa under enteral nutrition.~   "
10481|NCT02920060|"~     This study is a randomized, open label, parallel group,comparing the safety and efficacy of~     valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus~     not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS,~     BHU. The primary outcome measures will be Proportion of children in either group who have~     Cessation of all clinical seizure within 30 min of drug administration and secondary outcome~     will be time taken to control seizure (minutes) from the initiation of infusion. Proportion~     of children in either group who required additional drugs to abort ongoing clinical~     seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU~     stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus~     condition is major pediatric neurological emergency with high mortality and morbidity. Till~     now, the treatment guidelines for it are based primarily on retrospective studies with very~     few randomized studies. There is lack of sufficient data to recommend one drug over another~     for treatment of refractory status epilepticus.~   "
10482|NCT02920047|"~     The purpose of this study is to evaluate the pharmacokinetics and safety when administrated~     Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.~   "
10485|NCT02920008|"~     Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment~     choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or~     TC. TC options include the 8 high or low intensity, locally available regimens below; or~     Best supportive Care (BSC) alone:~        -  High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide,~          and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor~          [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).~        -  Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).~        -  BSC.~   "
10486|NCT02919995|"~     This study evaluates two doses of RPL554 and placebo in adult patients with cystic fibrosis.~     All patients receive all three treatments in a randomised sequence.~   "
10487|NCT02919982|"~     The purpose of this study is to establish a benchmark for rate of prescription of oral~     anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an~     ambulatory care setting, based on independent medical assessment of clinical data and~     physician and patient surveys. The study will also assess reasons for not prescribing OA to~     prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and~     patients' perspectives of non-use of OA for treatment of NVAF.~   "
10488|NCT02919969|"~     This research study is studying a targeted therapy as a possible treatment for advanced anal~     cancer.~      The following intervention will be involved in this study:~      -Pembrolizumab~   "
10489|NCT02919956|"~     Single ventricle lesions are the leading cause of illness and death from congenital heart~     disease. The modified Fontan Operation is the corrective surgery for these lesions. The~     operation is done in stages over a few years and children who complete the operation are~     known to have greater neurodevelopmental (ND) deficits than the general population. The~     purpose of this study is to understand how blood flow to the brain (CBF) and brain lesions~     relate to ND outcome, as well as how CMRO2 relates to anatomic brain lesions. These~     relationships will be studied through Magnetic Resonance Imaging (MRI) and ND Testing.~   "
10490|NCT02919943|"~     To define and evaluate the impact of angiographic coregistered OCT on physicians~     decision-making through prospective data collection in PCI procedures.~   "
10491|NCT02919930|"~     The purpose of this study is to compare the effects of nasal and oronasal interfaces during~     ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting~     treatment with ASV, will be randomized between two groups. In the first group, patients will~     use a nasal interface during the first night and an oronasal interface during the second~     night. In the second group, patients will use an oronasal mask first and a nasal mask during~     the second night. The results of this trial will have major impact on future clinical~     practice as it would deliver prediction rules to choose the correct interface immediately.~   "
10492|NCT02919917|"~     While treatment strategies for OH have been identified for use in persons with acute SCI,~     the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined~     outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH),~     regardless of symptoms, during acute rehabilitation and identifying the effects of two~     different treatment approaches on therapy participation and adherence to an intended~     rehabilitation plan could have a significant impact on clinical practice in the acute~     rehabilitation setting following SCI.~   "
10493|NCT02919904|"~     The feasibility of using the Apnea Risk Evaluating System (ARESTM) device to take~     longitudinal measures of sleep parameters in asymptomatic men with prostate cancer who are~     about to initiate androgen deprivation therapy (ADT) will be evaluated. Study participants~     will complete serial questionnaires relating to sleep quality, hot flashes, and quality of~     life.~   "
10494|NCT02919891|"~     This is a retrospective, observational study which will utilise the Edinburgh Cancer~     Research Centre's Tissue Bank to provide samples for IENFD testing in those who have~     undergone mastectomy surgery for breast cancer.~      The investigators shall identify all those patients in the Tissue Bank database who have~     undergone mastectomy surgery for breast cancer. The investigators shall consult the~     patient's electronic health record, and general practitioner if required, to ascertain~     whether the patient has died, been diagnosed with cognitive impairment or a psychotic~     disorder, or receiving ongoing oncological treatment which would exclude them from the~     study. The investigators shall also exclude all those patients who received surgery within~     the last year as we intend to elucidate the presence of pain in the immediate~     post-operartive period up to 12 months post-operatively.~      Having identified these patients the investigators shall contact them via post with a pack~     containing an information document, a consent form and questionnaires. As this is an~     observational study we shall contact all of the identified patients who meet the inclusion~     criteria with the aim of recruiting as many as possible. The investigators would anticipate~     a high response rate as has been the experience with previous questionnaire studies of~     breast cancer patients.~      Once a signed consent form has been returned the patient's tissue sample would undergo IENFD~     testing. Their questionnaire responses will allow participants to be split into two groups~     based upon whether they experience CPSP or not. Blinding of this grouping will take place so~     that those undertaking the IENFD testing are unaware of the patient's questionnaire~     responses.~      Statistical analysis of the two group's IEFD results and questionnaire responses will then~     be undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery~     does not predict or correlate with CPSP.~   "
10495|NCT02919878|"~     Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by~     Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.~   "
10496|NCT02919865|"~     Radiation therapy is an important adjunct in the treatment of patients with glioma, although~     a common side effect is radiation-induced injury of brain parenchyma. Unfortunately,~     conventional MRI is not accurate in differentiating radiation-induced brain injury from~     recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent~     studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI~     can be performed with an injection of exogenous contrast using dynamic contrast enhancement~     (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be~     performed without contrast injection using arterial spin labeling (ASL) or intravoxel~     incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to~     convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted~     contrast enhancement (DSC) perfusion is the most common technique used in clinical practice~     but measurement of tumor relative cerebral blood volume (rCBV) can be biased by~     extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this~     study is to evaluate the accuracy of perfusion MR imaging using non-contrast and~     contrast-based techniques in differentiating recurrent tumour from radiation-induced brain~     injury in patients with known high grade glioma. The investigators will compare the accuracy~     of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new~     different T1 mapping methods used for DCE-MRI.~   "
10497|NCT02919852|"~     The purpose of this study is to identify whether a new operative technic would be acceptable~     in female with pelvic organ prolapse.~   "
10500|NCT02919813|"~     The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior~     Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a~     counseling technique that has been shown to reduce pain and anxiety with other medical~     conditions, including chronic pain conditions. The investigators wish to see if~     participation in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV~     greater than education alone. Both techniques use a group setting including other women with~     PLV. Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized~     Vulvodynia is a study designed to learn more about the use of mindfulness based group~     cognitive behavior therapy for PLV pain and anxiety over education alone. Participants will~     be randomized to one of two groups: mindfulness based cognitive behavior therapy or group~     education seminars.~   "
10501|NCT02919800|"~     A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study~     to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous~     administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.~   "
10502|NCT02919787|"~     This study evaluate the additional effect of adding chemotherapy prior to resection of a~     pancreatic head malignancy. The patients will be randomized into two groups; surgery first~     (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall~     survival after resection~   "
10503|NCT02919774|"~     The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad~     Methionil, POMA) at selected doses on ketamine-stimulated glutamate release in prefrontal~     cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).~   "
10504|NCT02919761|"~     2 part multicenter study to examine the effect of Acthar in adult subjects with rheumatoid~     arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all~     eligible subjects receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar,~     subjects will be evaluated for treatment response using the DAS28-ESR. Subjects who have~     achieved low disease activity will enter a double-blind randomized maintenance period (Part~     2) and be randomized in a 1:1 ratio to receive either Acthar or matching placebo for an~     additional 12 weeks.~   "
10505|NCT02919748|"~     To evaluate the efficacy of choral singing in the prevention of dementia and examine the~     underlying mechanisms using Magnetic Resonance Imaging (MRI) technique and a panel of~     peripheral biomarkers in venous blood and urine. The investigators hypothesize that Choral~     singing could prevent cognitive decline among community-dwelling elderly who are at high~     risk of dementia. The underlying neural mechanisms involve the changes in brain structure~     and function that can be quantified using MRI technique. The changes in cognitive outcomes~     will be accompanied by observable changes from a panel of carefully selected peripheral~     biomarkers.~   "
10506|NCT02919735|"~     Phase II clinical trial~   "
10507|NCT02919722|"~     Investigators hypothesize, based on anecdotal evidence to date, that active music making~     interventions conducted on a patient's neglected side will result in improved attention to~     that side and that this will be measurable within session.~   "
10508|NCT02919709|"~     The study aims to investigate the existence of a reliable correlation between the~     progression of aortic diameters and blood levels of circulant endothelial progenitor cells~     CD34+ in patients with not surgical aortic aneurysms.~   "
10509|NCT02919696|"~     The purpose of this study is to determine the safety of the study drug known as abemaciclib~     in native Chinese participants with advanced and/or metastatic cancers.~   "
10510|NCT02919683|"~     This research study is studying nivolumab, an investigational drug, in combination with~     ipilimumab, also an investigational drug, as a possible treatment for Squamous Cell~     Carcinoma of the oral cavity.~      The following drugs are involved in this study:~        -  Nivolumab (Opdivo™)~        -  Ipilimumab (Yervoy™)~   "
10511|NCT02919670|"~     This research study is evaluating Enterade, a supplement, as a possible treatment for the~     side effects caused by Stem Cell Transplant.~      The following interventions will be involved in this study:~        -  Enterade plus standard supportive care~        -  Placebo plus standard supportive care. The placebo will be a mixture of water,~          electrolytes, and sweetener.~   "
10512|NCT02919657|"~     Genepro Gen2 Absorption and Protein Value Clinical Trial.~   "
10513|NCT02919644|"~     Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant~     vaccination with autologous dendtiric cells loaded with autologous tumour homogenate after~     curative resection for stage IV colorectal cancer~   "
10514|NCT02919631|"~     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,~     have insufficient breakdown of sugar stored as, glycogen, within the cells. The~     investigators know from previous studies with McArdle patients, that they not only have a~     reduced sugar metabolism, both also have problems in increasing their fat metabolism during~     exercise to fully compensate for the energy deficiency.~      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that~     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin~     has had a positive effect on the physical performance and has reduces the level of symptoms~     experienced by patients.~      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients~     with McArdle disease on exercise capacity.~      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen,~     Denmark and Hopital Pitié-Sapêtrière in Paris, France.~        1. Pre-experimental testing (1 day): Baseline blood samples are collected to obtain~          baseline values of safety parameters: Plasma-acylcarnitines, free fatty acids and~          creatine kinase. Subjects perform a max-test to determine their VO2max~        2. Treatment period #1 (2 weeks): Subjects follow a diet consuming a dietary treatment~          oil. Neither patients nor members of the study group know who receive which type of~          oil.~        3. Washout period (1 week +7 days): Subjects receive no treatment~        4. Treatment period #2 (2 weeks +7days): Subjects who received Triheptanoin oil in the~          first treatment period, now receive placebo oil and vice versa.~      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise~     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8~     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale~     questionnaire and metabolic products will be measured in blood and urine.~   "
10515|NCT02919618|"~     Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of~     Ventricular Tachycardia~   "
10516|NCT02919605|"~     Introduction: Up to the present, have been few studies with pentamidine in the Americas; and~     there is no consensus regarding the dose used.~      Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the~     treatment of cutaneous leishmaniasis.~      Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used~     at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be~     also assessed the safety and adverse effects. The sic will be reviewed one, two and six~     months after the end of the treatments.~   "
10518|NCT02919579|"~     The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg)~     dose of intranasal esketamine compared to placebo, on next day driving performance and~     repeated administration of 84 mg intranasal esketamine on same-day driving performance as~     assessed by the mean difference of standard deviation of lateral position (SDLP) from an~     on-road driving test.~   "
10519|NCT02919553|"~     The purpose of the study is to compare two particular techniques of tissue (capillary vs~     wet-suction techniques) sampling during endoscopic ultrasound guided fine needle~     aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and~     procedure logistics (e.g. procedure time).~   "
10520|NCT02919540|"~     This project aims at testing the effect of applying the KMC on the premature infants'~     physiological outcomes. The findings of this project are expected to contribute to the~     discipline of preterm infants' care by providing evidence of the benefits, barriers, and~     facilities of providing the KMC in our Jordanian NICUs.~   "
10521|NCT02919527|"~     Treatment or training of fascial tissues has moved into the focus of medical research in the~     last decade. In this context, the use of foam rollers or roller massagers for~     self-myofascial-release (SMR) techniques has become increasingly popular in health and~     fitness professionals. The primary objective of these techniques is to mimic manual massage~     or myofascial-release therapy with a self-usable tool. Recent studies suggest that SMR~     improves, inter alia, range of motion (ROM) without a decrease in neuromuscular performance~     (Cheatham et al. 2015).~      Concurrent effects on the muscle and especially the surrounding connective tissue network~     have been proposed as underlying mechanisms for these observed changes in ROM after SMR.~     Several authors assume a positive effect of SMR on sliding properties of different~     independent fascial layers. Also, changes in passive tissue stiffness is suggested. Passive~     stiffness is thereby characterized by passive resistance in the tissues' (muscles')~     functional direction, the passive resistive torque (PRT).~      In conclusion, for many of the proclaimed effects of SMR, such as improvements of sliding of~     fascial layers or decreases of passive stiffness, there is a lack of evidence in the~     literature. Therefore, the aim of the study is to evaluate acute effects of SMR on the~     viscoelastic properties of the muscles on the anterior thigh and the corresponding fascia.~      In a cross over design, 16 subjects receive all of the following interventions after a~     familiarization session: a) 2x60 seconds of SMR at the anterior thigh, b) 2x60 seconds of~     static stretching at the anterior thigh, c) no intervention in a balanced permutated~     randomization sequence. Before and directly after each intervention, outcome parameters are~     collected.~      Passive Resistive Torque is evaluated using a computerized isokinetic dynamometer. In~     passive mode, the lower leg is moved from full knee extension (0°) to the point of maximal~     knee flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hertz (Hz).~     Sliding of fascial layers is quantified with a frame-by-frame cross correlation algorithm of~     high-resolution ultrasound images (Dilley et al. 2001).~      First stretch sensation is quantified using the passive mode in the isokinetic dynamometer.~      Maximal ROM is detected using a an ultrasonographic movement analysis system in a prone~     position.~   "
10522|NCT02919514|"~     To investigate effects of soft, sand and hard surfaces on functional ability and falls in~     elderly with or without history of multiple falls.~   "
10523|NCT02919501|"~     To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and~     vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on~     depressive symptoms~      To evaluate the early onset of efficacy of vortioxetine 17 mg IV and vortioxetine 10 mg/day~     oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on~        -  global clinical impression~        -  anxiety symptoms~      To determine population pharmacokinetic parameters of vortioxetine~   "
10524|NCT02919488|"~     The purpose of this study is to determine if postprandial (after a meal) endothelial (inner~     lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of~     exercise~   "
10525|NCT02919475|"~     This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of~     JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are~     receiving background non-biologic disease-modifying anti-rheumatic drug therapy.~   "
10526|NCT02919462|"~     This is an open-label, multicentre, randomized phase II trial.~      Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase~     (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:~      A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral~     Vinorelbine until disease progression~      B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease~     progression~      Treatment will be repeated every 21 days .~   "
10527|NCT02919449|"~     This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of~     attenuated Measles virus (MV-NIS) combined with nivolumab in patients with recurrent and~     metastatic (NSCLC).~   "
10528|NCT02919436|"~     Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to~     tamsulosin versus a placebo.~   "
10529|NCT02919423|"~     The purpose of this study is to investigate the modulatory effects of repetitive~     transcranial magnetic stimulation (rTMS) on functional connectivity with the insula.~     Functional connectivity (FC) measures the interaction between brain regions, and recent~     neuroimaging studies have used FC to investigate how addiction affects FC among pertinent~     brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to~     manipulate brain connectivity and could be used therapeutically to treat addiction. However,~     investigators first need more information on brain FC and how it relates to behavior, in~     order to guide rTMS target selection.~   "
10530|NCT02919410|"~     This is a prospective, randomized control trial evaluating the efficacy of~     iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.~   "
10531|NCT02919397|"~     The overall aim of this feasibility trial is to assess the effectiveness of a wearable~     technology and an e-diabetes prevention programme delivered via a smartphone application,~     including motivational messaging, in reducing weight and increasing physical activity in~     people at risk of developing type 2 diabetes.~   "
10532|NCT02919384|"~     During this study, patients will undergo a routine in vitro fertilization cycle as they~     would otherwise if not participating in the study. After eggs have been fertilized they will~     be cultured as usual until day 3 of embryo development. On day 3 of development, the~     embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration~     and the other half at 5%, which is currently the standard of care. All other embryological~     care procedures will remain the same. On day 5 or 6 of embryo development, the embryos will~     be evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be~     the blastulation rate (or percentage of embryos that reach the blastocyst stage).~   "
10533|NCT02919371|"~     Combined sunitinib and bevacizumab in advanced renal cell carcinoma.~   "
10534|NCT02919358|"~     The purpose of this study is to investigate the effect of classical music exposure on~     improved time to regain birth weight and improved feeding readiness in healthy premature~     infants in the NICU.~   "
10535|NCT02919345|"~     Background Endothelial dysfunction is one of the early events in atherosclerotic plaque~     development. It is characterized by an increased ratio of substances with vasoconstrictive,~     pro-thrombotic, and proliferative properties over substances with vasolidatory,~     antithrombogenic and antimitogenic properties. Endothelial dysfunction is also associated~     with high-risk patients with coronary artery disease. Hyperglycemia, obesity, hypertension~     and fat mass also impair the endothelium by increasing the expression of cytokines,~     inflammatory markers and vascular markers.~      Hypothesis Administration of dapagliflozin in addition to metformin background with clinical~     or subclinical cardiovascular atherosclerotic disease improves endothelial function when~     compared to those using glibenclamide in addition to metformin.~      Objectives Evaluate the effect of dapagliflozin vs glibenclamide on a metformin background~     on endothelial function in patients with clinical or subclinical cardiovascular~     atherosclerotic disease and poorly controlled diabetes.~      Enpoints Prymary Change in flow mediated dilation (FMD) and its related endpoint (FMD post~     reperfusion lesion) between the randomization visit and over 12 weeks of treatment.~      Secondary Change in plasma nitric oxide, isoprostane, ICAM-1, VCAM-1, ET-1, leptin,~     adiponectin, C-reactive protein, TNF- α, interleukin-6, interleukin-2, weight and body~     composition (% of fat mass and % free fat mass) at the randomization visit and over 12 weeks~     of treatment.~      3~      Design Randomized, parallel-group, comparative, prospective clinical study. The study is~     divided in two phases: Run-in and Randomization. In the former phase, which must have the~     maximum period of 16 weeks, patients will visit the outpatient to adjust metformin and blood~     pressure medications. After run-in phase, patients that fulfill inclusion criteria will~     perform an ambulatory blood pressure monitoring (ABPM) in order to asses BP; body~     composition will be assessed by dual x-ray absorptiometry (DXA); endothelial function as~     assessed by flow mediated dilation and vascular cytokines. Patients will by randomized to~     dapagliflozin or glibenclamide on a metformin background. After 12 weeks, the ABPM, DXA and~     endothelial function will be assessed.~   "
10536|NCT02919332|"~     This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron~     emission tomography (PET)/computed tomography (CT) works in improving visualization of brain~     tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by~     tumors in the brain and are visualized using PET/CT. Increasing the interval of time between~     18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in~     patients with glioblastoma.~   "
10537|NCT02919319|"~     The main objectives of this first-into-man study were to investigate the safety,~     tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy~     male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests)~     were also assessed.~   "
10538|NCT02919306|"~     The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26~     (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on~     suppressive antiretroviral therapy (ART) that was initiated during acute Human~     Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained~     viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24~     weeks with plasma HIV ribonucleic acid (RNA) lesser than (<)50 copies/ml after~     antiretroviral (ARV) analytical treatment interruption (ATI).~   "
10539|NCT02919293|"~     To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A~     and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.~      Primary objective:~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal~          serogroups A, C and Haemophilus influenzae type b following the administration of~          adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the~          administration of adjuvant MenAC-Hib conjugate vaccine.~        -  To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to~          that of adjuvant MenAC-Hib conjugate vaccine.~      Secondary objective:~      •To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae~     type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those~     observed following the administration of adjuvant MenAC-Hib conjugate vaccine.~   "
10540|NCT02919280|"~     The Dallas 2K is a 5-year natural history, longitudinal, prospective study of a cohort of~     2,000 participants that will help uncover the socio-demographic, lifestyle, clinical,~     psychological and neurobiological factors that contribute to anti-depressant treatment~     response: remission, recurrence, relapse and individual outcomes in depressive disorders.~     Hence, the expected duration of this study is 10 years in length. Since this is an~     observational study, investigators will explore a comprehensive panel of carefully selected~     participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle~     (physical activity, substance use); clinical (medical history, anxious depression, early~     life trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive,~     emotional), neurophysiological (EEG), and neuroimaging (structural, functional brain~     circuitry) with the goal to develop the most robust predictive models of treatment response~     and of depression outcomes. There is no medication or non-medication treatment or~     intervention provided by this study.~      Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive~     disorder and will be currently receiving or will be prescribed standard of care medication~     or non-medication based treatments by their providers/clinicians. The study cohort will~     reflect the wide range of patients seen in typical primary or psychiatric care settings, and~     may include unipolar or bipolar disorders and dysthymia (a more chronic form of depression).~     The cohort will be broadly representative of and generalizable to the US general population~     as a whole.~      Participants will be recruited from the UT Southwestern Depression Cohort, a registry of~     volunteers who have consented to learn more about participation in depression-related~     research studies -(IRB STU: 092015-049). Participants external to the Depression Cohort will~     first be consented and enrolled in the Depression Cohort before being consented and enrolled~     in the Dallas 2K study.~   "
10541|NCT02919267|"~     Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic~     anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double~     lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during~     OLV is not well described in the literature. Few publications characterized scant aspects of~     lung collapse, only with the use of DLT and sometime in experimental animals. Two phases of~     lung collapse have been described. The first phase is a quick and partial secondary to the~     intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the~     alveoli by the capillary bed. The investigators plan to describe the physiology of the~     second phase of lung deflation using of DLT or BB, in a human clinical context.~   "
10542|NCT02919254|"~     The purpose of this study is to examine the effect of varying nitrate doses of beetroot~     juice supplementation on dynamic, multijoint resistance exercise performance in active,~     trained individuals. Performance will be assessed based on parameters including~     neuromuscular efficiency, anaerobic performance capability, oxygen consumption, plasma~     nitrate/nitrite levels, specific muscle tissue biomarkers including lactate, and~     anthropometric measurements of select muscle groups.~   "
10543|NCT02919241|"~     Clinical trial of an application of cognitive behavioural one-session therapy method with~     patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety~     Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and~     one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst~     & Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from~     three different places,primary care clinic, community dental care and dentist´s teaching~     clinic.~   "
34340|NCT02607592|"~     The purpose of this study is to investigate the overall toxicity value（OTV）, PFS, ORR and OS~     on advanced adenocarcinoma treated with nadaplatin or cisplatin combined with pemetrexed.~   "
10544|NCT02919228|"~     NOTE: This is the fourth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
10545|NCT02919215|"~     Teachers are increasingly faced with classrooms of students whose needs require support far~     beyond what traditional teacher-training programs prepare educators to provide. The presence~     of students with greater challenges in classrooms is due in part to the move to a full~     inclusion model of education and also to the rising epidemic of mental health disorders in~     youth. Mental health problems affect up to one million Canadian youth and their families.~     However, few of these individuals (~20%) receive the support they need (Kirby, 2013; Kutcher~     & McLuckie, 2013). The Teacher Help research team along with industry partner, Velsoft, and~     key knowledge user, Nova Scotia Department of Education and Early Childhood Development,~     will address this barrier by developing, evaluating, and commercializing a sustainable~     eHealth resource for teachers. Teacher Help is an online program that assists teachers in~     providing evidence-based interventions to students in grades 1-12 with mental health~     disorders in the classroom. The program allows teachers in a typical classroom setting to~     access information and expert-coach and peer support when they need it, so they can~     intervene early in order to reduce the negative consequences of mental health disorders in~     youth. Currently three modules (Attention-Deficit/Hyperactivity Disorder [ADHD], Autism~     Spectrum Disorder [ASD], and Learning Disabilities [LD]) are at different stages in the~     innovation pipeline. The investigators will test whether teachers make good use of this~     program and whether it is effective in improving mental health outcomes among children and~     youth both at school and at home. The investigators will also study whether the program~     changes teacher's attitudes toward children and youth with these disorders. The~     investigators will provide information to the Department of Education on how to use this~     program. This approach will help ensure that the program will continue after the research~     study ends. To the Teacher Help team's knowledge Teacher Help is the first and only~     research-validated eHealth program directly targeting teachers to help them intervene with~     children and youth who have mental health disorders, thus allowing Canada to take a lead in~     eHealth as applied to a school context.~   "
10546|NCT02919202|"~     This study compares the efficacy of two dental interventions in the treatment of cervical~     dentine sensitivity. The participants will be selected from adult dental patients registered~     at a general dental practice in West Sussex, UK. The participants will be split into 2~     groups. One group will receive the intervention of topical fluoride varnish application~     while the other group will receive a topical application of self-etching dentine bonding~     agent.~   "
10547|NCT02919189|"~     NOTE: This is the fifth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
10548|NCT02919176|"~     This is an open lable, pilot study in which the investigator will research the effect of two~     FDA approved drugs, Mirabegron and Pioglitazone on fat tissue.~      Pioglitazone is drug approved by the FDA for the treatment of diabetes and Mirabegron is a~     drug that is approved by the FDA for the treatment of overactive bladder. These drugs are~     not approved by the FDA for the purposes being studied in this research. Therefore, the way~     in which the investigator intends to use them in this study are considered investigational.~   "
10549|NCT02919163|"~     NOTE: This is the sixth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
10550|NCT02919150|"~     The aims of this study are:~        -  To examine the inter-rater reliability to assess myofascial trigger points using a~          myotonometer~        -  To determinate the strength of the correlation between myotonometric parameters and~          isokinetic parameters~        -  To evaluate the sensitivity of myotonometric measurements to detect the location of~          myofascial trigger points~   "
10551|NCT02919137|"~     NOTE: This is the seventh of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
10552|NCT02919124|"~     The aim of this study is to evaluate whether use of the echoclip device (an ultrasound~     transducer positioning device which can stabilize the involved part of the myocardium on the~     beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass~     surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass~     surgery will be included in the study in order to evaluate if the surgeons can visualize the~     coronary anastomoses before closure of the sternum. Ultrasonograpic pictures will be~     analyzed directly peroperatively and electronically post-operatively in order to evaluate if~     selected areas of the anastomoses can be visualized. Use of the echoclip devise will be~     considered a success if at least 80% of the anastomoses can be visualized.~   "
10554|NCT02919098|"~     The investigators have developed a game-based sexual violence prevention program that uses a~     bystander intervention approach. This program is called Bystander and was designed for use~     with high school students in grades 9-12. The goal of this research is to evaluate the~     efficacy and feasibility of Bystander when implemented in a school setting. The research~     will capture data on knowledge about sexual violence and harassment, as well as attitudes,~     self-efficacy, perceived social norms and behavioral intentions around bystander behaviors.~     This research will consist of a baseline survey, program participation, a immediate~     post-program survey, and a 3-month follow up survey with youth participants. It will also~     involve qualitative in-depth interviews with school staff and administration about the~     program.~   "
10555|NCT02919085|"~     To analyze changes on respiratory muscle strength, peripheral and functional capacity of~     critically ill patients with clinical and surgical etiology, breathing spontaneously and~     bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are~     correlations among these variables. This is an observational study. Respiratory muscle~     strength will be assessed through the maximum inspiratory pressure (MIP) and maximal~     expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council~     score (MRC) and hand grip test and functional capacity through the Functional Independence~     Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and~     48h of hospitalization in the adult ICU. For descriptive purposes, the sample will be~     stratified according to clinical and surgical characteristics. Correlations will be~     determined using the Pearson test, with significance level of p <0.05.~   "
10556|NCT02919072|"~     The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl~     3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ~     undergoing unplanned Caesarean section.~   "
10557|NCT02919059|"~     This superiority of central pressure versus peripheral measures to predict cardiovascular~     events has also been reported in general population or in elder people~   "
10558|NCT02919046|"~     This single-arm, multicenter clinical study will treat the patient who have relapsed or~     refractory neuroblastoma with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour~     cells modified to express the GD2 protein on the cell surface. The study will determine if~     these modified T cells help the body's immune system eliminate tumour cells .The trial will~     also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's~     body and the impact on this treatment for survival.~   "
10559|NCT02919033|"~     This three arm study is to compare the effects of a coordinated PCP-Cardiologist~     Telemedicine Model (PCTM) with usual care and self-care in community hypertension management~     in China.~   "
10560|NCT02919020|"~     To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF)~     as physical therapy approach to the reduction of pain and improvement in functional~     performance and quality of life in women with knee osteoarthritis.~   "
10561|NCT02919007|"~     This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.~   "
10562|NCT02918994|"~     The purpose of this investigation is to conduct a series of case studies on the impact of~     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning~     for participants with Traumatic Brain Injury (TBI).~   "
10563|NCT02918981|"~     Using stable isotope methodology, investigators will determine the postabsorptive and~     postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: <30~     kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided~     in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage~     or placebo to consume following the resistance exercise training. Group 1 will consume a~     beverage consisting of whey protein; group 2 will consume whey protein supplemented with~     additional leucine; group 3 will consume whey protein supplemented with additional leucine~     and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional~     leucine and citrulline; group 5 will just consume water. During the testing, blood and~     muscle samples will be collected.~   "
10564|NCT02918968|"~     The objective of this study is to compare the efficacy and safety of the combination therapy~     with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with~     flutamide + ADT in patients with castration resistant prostate cancer who have relapsed~     during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study will~     also investigate the order of alternative antiandrogen therapy (AAT) by changing the 1st~     line medication after relapse of prostate-specific antigen (PSA).~   "
10565|NCT02918955|"~     Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a~     multidisciplinary approach with a combination of surgery, radiotherapy (RT) and~     chemotherapy. Due to these aggressive combined modalities, patients undergoing treatment and~     many survivors develop toxicities which impact quality of life (QoL) and sometimes lead to~     mortality.~      Lymph node metastases of HNSCC are frequent and considered one of the most important~     prognostic factors, resulting in decreased survival by 50%. More than three decades, the~     optimal management strategy of node positive HNSCC was a key subject of debate. In summary,~     the current literature provides us two important findings: First, with the contemporary~     imaging and treatment modalities, there is no role of a planned neck dissection (ND) added~     to (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with~     modern RT techniques, a tailored treatment followed after an up-front neck dissection (UFND)~     allows a significant reduction of treatment volumes and de-escalation of the dose to the~     neck, leading to reduction of treatment related toxicities.~      In this study strategies with and without up-front neck dissection prior to~     chemo-radiotherapy will be compared.~   "
10566|NCT02918929|"~     This randomized, double-blind, placebo-controlled study will assess the safety,~     tolerability, and pharmacokinetics of single and multiple orally administered doses of~     EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese~     subjects with or without prediabetes or T2DM).~   "
10590|NCT02918617|"~     This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing~     toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a~     commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin®~     technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium~     monofluorophosphate (MFP).~   "
10567|NCT02918916|"~     Introduction: Recent studies have shown positive results from the application of~     phototherapy for the improvement of performance and acceleration of the recovery process~     both in the application before and after exercise. However, the effects of phototherapy~     during combined training and after a primary adaptation process remain unclear.~      Research objectives: The primary objective of the study is to analyze and compare the~     effects of phototherapy using different light sources (laser and light emmiting diode - LED)~     interacting with combined training on clinical, functional, and psychological outcomes and~     vascular endothelial growth factor. The secondary objective is to compare the benefits~     provided by phototherapy in participants with different levels of training adaptation.~      Design: A controlled trial, double-blind, placebo-controlled will be conducted with~     stratified randomization and concealed allocation.~      Participants and Setting: After fulfilling the eligibility criteria, forty-five male~     participants will participate in the study.~      Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints~     and squats). In phase 2, participants will be allocated, through stratified randomization~     (based on adaptation capacity to training), into three groups: active phototherapy group~     (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training~     period will then start. In this phase the participants will carry out training normally with~     the adjusted loads and between sprints and squats will receive the recovery strategy related~     to the group to which they belong.~      Intervention: Active and placebo phototherapy will be applied by a trained therapist,~     between sprints and squats. During the period of recovery strategies for the AG and PG, the~     CG participants will remain seated for passive recovery, supervised by an independent~     therapist.~      Measurements: The measurements include clinical, functional, and psychological outcomes and~     vascular endothelial growth factor.~   "
10568|NCT02918903|"~     The objective of this study is to assess and compare the possible post-operative pulpal~     symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of~     pulp exposure, child acceptance, chair time and radiographic success between two techniques~     for managing dental caries: minimal caries removal and complete caries removal in primary~     molars.~   "
10569|NCT02918890|"~     A randomized control trial examining the relationship between changes in hand function and~     brain plasticity following intensive therapy. Two treatment approaches are used:~     constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT).~     The protocols have been developed at TC Columbia University to be child friendly and draw~     upon our extensive experience with constraint-induced movement therapy in children with~     cerebral palsy. Our center has been providing interventions camps for children with cerebral~     palsy since 1998. The interventions are performed in a 15 day day-camp setting with several~     children and at least one interventionist per child. The aim of the intervention is to~     improve the use of the affected hand and quality of overall movement in a fun, social~     setting. PARTICIPATION IS FREE. Please check out our website for more information:~     http://www.tc.edu/centers/cit/~   "
10570|NCT02918877|"~     The purpose of this study is to investigate whether the use of inhaled anesthetics, compared~     to intravenous anesthetics, can effect the amount of lung inflammation and postoperative~     respiratory complications seen after cardiac surgery.~   "
10571|NCT02918864|"~     The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy~     of integrating targeted dosing of intranasal oxytocin with a social cognitive skills group~     therapy for school-aged children with autism spectrum disorder (ASD).~   "
10572|NCT02918851|"~     This is a single-center, randomized, partially blinded study to determine whether 42-day old~     red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine~     whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to~     oxygen delivery.~      In this study, subjects will be randomized to be transfused with 2 units of autologous~     (one's own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in~     exercise duration and VO2 max (test of oxygen consumption/delivery) between groups.~   "
10573|NCT02918838|"~     This study is an extension of Reminding Adolescents to Adhere (RATA) (Unique protocol ID:~     1R01HD074925-01). Participants for SATA will be recruited during the RATA month 24 exit~     survey.~      Participants will be randomized 1:1:1 into either one of two intervention group (receiving~     the weekly messages and a chance to draw a prize at each clinic visit based on either a~     fixed adherence level of 90% or a self-chosen one of at least 80% as further detailed below)~     or the control group that receives the existing RATA intervention consisting of weekly~     motivational messages and the chance to get mobile airtime rewards conditional on~     responding. Doing so will allow the investigators to cleanly evaluate the impact of these~     additional adherence-based lotteries, and guarantees that those who have been in the control~     group receiving standard of care in the first 24 months of the RATA intervention will also~     receive an intervention for reasons of fairness.~   "
10574|NCT02918825|"~     A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the~     treatment of 100 treatment- naive first-episode patients with schizophrenia.~   "
10575|NCT02918812|"~     This study compares the effect of intracervical block with 1% lidocaine and intramuscular~     diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of~     participants will receive intracervical block with 1% lidocaine, while the other half will~     receive intramuscular diclofenac 75mg.~   "
10576|NCT02918799|"~     This project will adapt and pilot a multi-level, community-based intervention to promote HIV~     prevention and sexual health among young men who have sex with men in Beirut.~   "
10577|NCT02918786|"~     The purpose of this study is to compare the effect of continuous positive airway pressure~     (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula~     oxygen therapy in mechanically ventilated patient who are at risk for postextubation~     failure.~   "
10578|NCT02918773|"~     Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading~     cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis~     of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative~     child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization~     of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the~     tympanic membrane including capturing still images and recording video of the ear exam would~     be beneficial in the diagnosis and management of otic complaints, including acute and~     chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician~     ability to manage otic complaints, visualize the tympanic membrane, and support~     antimicrobial stewardship. This study will be conducted as a randomized control study in two~     affiliated children's hospital emergency departments. Twenty volunteer clinicians will be~     randomly assigned to use either a smartphone otoscope or a conventional otoscope for all~     otic examinations for a 6-month period.~   "
10591|NCT02918604|"~     multicenter, prospective and cohort study to evaluate infrared technology for identifying~     and and indwelling peripheral veins in 0 up to 4 years old children.~   "
14520|NCT02867215|"~     The aim of this study was to compare the metabolic effects of consuming whole barley bread~     and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain~     flour on mineral status.~   "
10579|NCT02918760|"~     Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment~     of chronic pelvic pain in females.~      The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will~     be enrolled each arm.~      Group A (cases):~      This group will include (32) women according to inclusion and exclusion criteria and will~     receive a card of Gabapentin which will be taken orally by the patient at home three times~     daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain~     relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.~     Group B (controls):This group will include (32) women .~      Assessment of the patient's pain during the physical examination will be done using the~     Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line~     at a point which is corresponding to the intensity of her pain. One end of the line denotes~     no pain and the other end of the line indicates that pain is as bad as it can be (the worst~     pain).the distance in cm from the low end of VAS to the patient's mark will be used (it~     gives a number.Questionnaire: will be given to all participants at randomization (0 months)~     , at 3 months and at 6 months to assess the degree of pain improvement via VAS.~      Patients' overall satisfaction with their pain treatment &Side effect recording (e.g.,~     dizziness, somnolence, mood changes, appetite and poor concentration).~   "
10580|NCT02918747|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's~     lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm~     prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen~     achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study~     to compare the efficacy of these two regimens. This prospective pilot study to compare the~     efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen~     for stage IE to IIE ENKTL.~   "
10581|NCT02918734|"~     In this randomized controlled trial the investigators will compare the results after primary~     anterior cruciate ligament (ACL) reconstruction using two different methods for femoral~     fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the~     standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have~     been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become~     available and the clinical results have been described as promising; however, no randomized~     controlled trials comparing these two femoral fixation methods have been conducted, and~     there is no published data that confirms that the bone block heals in the tunnel with the~     newer method.~      The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB~     autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.~   "
10582|NCT02918721|"~     The purpose of this study is to evaluate the pain and safety associated with injections of~     Restylane Lidocaine compared to Restylane using a visual analogue scale.~   "
10583|NCT02918708|"~     The National Vaccine Evaluation Consortium conducts Department of Health funded trials~     trials to provide information to underpin changes to the national immunisation and~     vaccination schedule.~      This study will assess how different schedules of pneumococcal conjugate vaccines work in~     providing protection to young infants. It is well established that vaccines can behave~     differently depending on which order they are given and alongside which other immunisations.~     This has been shown for Hib and MenC vaccines, which are similar in structure to the~     pneumococcal vaccines that will be studied here. The investigators will measure responses to~     the pneumococcal vaccines as well as to other routine immunisations, all of which will be~     provided by our study team. Infants will be recruited by dedicated study staff through~     primary care and will participate from their first vaccinations at 2 months of age, until~     the blood sample taken a month after their boosters at a year old, i.e. until 13 months of~     age.~      Any child found to have antibody levels below that which indicates protection for Hib, MenC,~     MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra~     dose of the relevant vaccine(s).~   "
10584|NCT02918695|"~     The purpose of this study is to compare clinical judgment and comprehensive geriatric~     assessment as screening tools for optimization of treatment for newly diagnosed elderly~     multiple myeloma patients.~   "
10585|NCT02918682|"~     This study evaluates if a multi-component intervention, respecting the characteristics of~     frail older person and increasing intensity and challenge of exercises according to frail~     older person capacity/evolution will induce better functional results than a multi-component~     intervention specific to lower body. the volunteers will be randomized into experimental~     group and control group.~   "
10586|NCT02918669|"~     Examine the long-term survivorship via CT Scan of the coflex in patients who presented with~     spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.~   "
10587|NCT02918656|"~     The objective of the investigators study is to evaluate the efficacy of infographics in~     presenting information, in terms of understanding and remembering research results, compared~     to standard PLS formats and scientific summary formats (SciSum).~   "
10588|NCT02918643|"~     Objective: To develop and evaluate the effectiveness of a mobile application to support~     decision making for prescription drugs to elderly patients. Method: Firstly, there will be a~     two-tier content validation of potentially inappropriate medicines (PIM) for the elderly~     based on Beers Criteria and STOPP. For the validation, a modified Delphi consensus technique~     will be applied. Twelve national experts will be invited. For each statement contained in~     the Beers criteria and STOPP a proposition will be prepared in order to allow each~     participant to issue an opinion on each of the propositions by assigning a value according~     to their agreement to the statement. Therefore, the Likert scale with established score of 1~     to 5 (completely disagree - strongly agree) will be used. Statements with average scores~     above 4.0 will be considered consensus. All information regarding PIMs will be made~     available through an application for tablets. The information on risks and recommendations~     about the drugs will be available whenever the users enter the medicines name. The~     application will be developed for the Android platform, which is based on the Java~     programming language. To evaluate the use of this application 30 doctors working in basic~     health units and health units of the family in a municipality from Bahia will be asked to~     join the study. Upon acceptance, the proportion of PIMs' prescription by these professionals~     for a minimum period of two months will be analyzed. Later, 15 doctors will be randomized~     into the intervention group and will receive a tablet with the application installed. They~     will be trained to use it as well as to access to the Evidence Based Health Portal of the~     Ministry of Health. The control group of 15 other physicians will receive the tablet and~     will be trained to access the Evidence Based Health Portal. The study will be blind to the~     participants and to the main investigator. To continue, the information will be analyzed by~     sampling the PIMs' prescription in both groups. To access this information the~     prescriptions' duplicate original, filed in pharmacies, patient files or home visit will be~     required. The PIMs prescription ratios before and after the intervention will be compared.~   "
10589|NCT02918630|"~     The purpose of this study is to assess if access to an electronic nicotine delivery device,~     or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking~     among individuals diagnosed with schizophrenia compared to nicotine patch alone.~   "
10592|NCT02918591|"~     It has been shown that in patients with type 2 diabetes (T2D) at high risk for~     cardiovascular disease (CVD) who received Empagliflozine as compared with placebo had a~     lower rate of death from cardiovascular causes, non-fatal MI, or non-fatal strokes as well~     as death from any cause and hospitalization for heart failure.~      This lower incidence of cardiovascular disease in individuals treated with selective~     inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction~     of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of~     Klotho.~      Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of~     Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate~     that patients treated with Empagliflozine will have decreased levels of FGF23 and increased~     levels of Klotho which would provide a good explanation for the beneficial cardiovascular~     effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)~   "
10593|NCT02918578|"~     The purpose of this study is to compare different modalities to communicate a remote and~     individually tailored physical activity promotion program.~   "
10594|NCT02918565|"~     A 5-arm randomized trial to determine what components of a text message intervention are~     necessary to reduce hazardous drinking among young adults and mechanisms through which these~     changes occur.~   "
10595|NCT02918552|"~     This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in~     subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive~     and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle~     bioenergetics, serology including inflammatory markers and platelet bioenergetics, quality~     of life measures.~   "
10596|NCT02918539|"~     This registry will be used to identify patients who have etiology diagnosed or suspected to~     be Alzheimer's disease and positive amyloid scans, and have indicated their interest in~     being contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research~     trial.~   "
10597|NCT02918526|"~     The purpose of the study will be to record the hemodynamic response measured by traditional~     methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in~     patients undergoing laryngeal mask placement compared with the hemodynamic response measured~     in patients undergoing laryngoscopy and tracheal intubation for performing surgery in~     gynecological area and assess the differences with the two methods.~   "
10598|NCT02918513|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition.~   "
10599|NCT02918500|"~     This study will determine whether or not patients who use a Nicotine Replacement Therapy~     (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after~     their surgery and have fewer post-operative complications~   "
10600|NCT02918487|"~     The aim of this trial is to study the effect of a polyherbal capsule containing four herbs:~     Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of~     bronchial asthma.~   "
10601|NCT02918474|"~     An online decision support tool will be field tested that provides patients facing a~     decision about contralateral prophylactic breast cancer (CPM) with evidence-based~     information about the expected incidence of contralateral breast cancer and the life~     expectancy benefit of CPM. The tool will be designed for use in clinical settings and viewed~     jointly by the patient and physician as part of a shared decision making process around CPM.~   "
10602|NCT02918461|"~     At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a~     6-week psycho-educationally-based, cognitive behavioral program to help patients with~     subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™~     (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.~      The objective of this study is to quantify the impact of a trainee-taught Emerging from the~     Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the~     change of FACT-Cog score.~   "
10603|NCT02918448|"~     Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade~     inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the~     effects of a 12-week resistance training (RT) program on body composition, risk factors for~     metabolic syndrome (MetS), and inflammatory biomarkers in older adult women~   "
10604|NCT02918435|"~     This research project is aimed to assess the implementation, effectiveness, and~     sustainability of a pediatric-based intervention aimed at reducing families' unmet material~     needs (food, housing, employment, childcare, household heat, education) in pediatric~     practices throughout the United States.~   "
10605|NCT02918422|"~     To determine the effects of high cheese diets varying in carbohydrate content on markers of~     disease risk.~   "
10606|NCT02918409|"~     The purpose of this study is to find the safest and most effective way to administer IV~     antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis~     (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the~     safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin.~     Though regularly used, not much is known about how these drugs compare with each other in~     terms of their toxicities, both during short term treatment of an APE and after many~     treatment courses with these drugs over many years. There are currently no guidelines on the~     safest and most effective antibiotics to use when treating APEs. We will study kidney~     function, sputum cultures, and treatment outcomes in patients receiving routine~     administration of one of these two IV antibiotics. We will also test these outcomes in~     patients receiving a less frequent dosing schedule for IV colistin. The hope is that this~     new schedule for IV colistin, which is twice a day and adjusted based on blood and urine~     tests, will reduce harmful side effects, such as kidney damage, while still being a powerful~     treatment against CF microbial pathogens.~   "
10627|NCT02918136|"~     This is a prospective, randomized, multi-site, safety and efficacy study in subjects with~     rotator cuff injuries.~      Patients will fall into two categories: treatment group (12 subjects) and non-treatment or~     control group (six subjects). The treatment group will undergo a small liposuction procedure~     and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc~     adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive~     a 5cc cortisone injection into the point of injury~   "
10607|NCT02918396|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with increasing~     morbidity and mortality. A catheter-based AF ablation technique that isolates pulmonary~     veins (PV) from the left atrium has been established to disrupt AF. Despite significant~     development, AF ablation with pulmonary vein isolation (PVI) is reported to have a success~     rate of 40-80% in various AF populations.~      Persistent AF appears to be more reliant upon fibroblast proliferation and~     myocyte-fibroblast coupling than paroxysmal AF with obvious implications on its management.~     Despite the knowledge that fibrotic substrate is responsible for the perpetuation of~     persistent AF, several ablation techniques targeting these extra-pulmonary veins sites have~     failed to prove an additional benefit to PVI alone. Nevertheless, two recently developed~     technologies, aimed at detecting AF substrate with high precision, seem to constitute a~     potential breakthrough in the management of persistent AF. On one hand, late~     gadolinium-enhanced MRI (LGE-MRI) is a well-established method to identify fibrosis in the~     myocardium. Recent reports from a single center have shown that MRI-based left atrial~     fibrosis detection is able to predict the outcome of the procedure. Hence, targeting lesions~     seen on LGE-MRI in the setting of persistent AF is an option yet to be explored and compared~     to the widely adopted, yet suboptimal, PVI. On another hand, a novel ablation method with~     promising results is focal impulse and rotor modulation (FIRM). Undergoing wide sampling of~     the atria with spatiotemporal and computational mapping while in AF has identified areas~     with stable organized rotational electrical activity (rotors). Several studies are under way~     to prove the reproducibility of rotor mapping, with more groups reporting improved rates of~     acute and long-term suppression of AF with ablation of FIRM-identified rotors.~      The SIMPle AF study will be a randomized clinical trial designed to test the hypothesis that~     ablation tailored to the underlying substrate using either LGE-detected dense scar or rotor~     anchor sites predicted by computational modeling is superior to anatomic non-tailored PVI~     ablation in patients with persistent AF. For the present study, the investigators plan to~     enroll a total of 30 patients.~   "
10608|NCT02918383|"~     Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been~     utilized to assess the viability of soft tissue, most prominently in the general surgery and~     plastic surgery literature. This technique has been used for prediction of soft tissue~     viability by assessing the perfusion status. There is currently no Orthopaedic literature~     regarding the use of this device for assessment of subchondral perfusion of articular~     surfaces such as the distal femur or other chondral surfaces.~      In this pilot study, the use of ICG to detect the perfusion status of a distal femur and~     proximal tibia during a surgical approach to the knee and correlating this to visible signs~     of arthritis. For example, due to the difference visible with ICG angiography correlate to~     gross changes in the cartilage health visible to the naked eye with radiographic imaging.~   "
10609|NCT02918370|"~     The investigators will conduct a 12-week, randomized, double-blind, parallel-group,~     placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and~     bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess~     change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include~     change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in~     psychiatric symptoms (mania/hypomania and depression) and predictors of response will be~     assessed. Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week~     extension phase with an upward titration to 30 mg/day for those in the active treatment~     group. The placebo group will remain on placebo.~      Subjects will be discontinued from the study if any of the following conditions occurs:~     change in diagnosis to other than bipolar I or II disorder and AUD, development of active~     suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the~     opinion of the investigators requires discontinuation, pregnancy, development of severe or~     life-threatening medical condition, involuntary psychiatric hospitalization or~     incarceration, significant alcohol withdrawal (e.g. delirium tremens) based on clinical~     judgment (increases in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores~     will initiate a careful clinical assessment of possible worsening of withdrawal symptoms),~     or cocaine or amphetamine-positive urine drug screen during the study.~   "
10610|NCT02918357|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients~     with biochemical recurrence after prostatectomy and radiation therapy.~   "
10611|NCT02918344|"~     The goal of this study is to determine if the use of calcium phosphate paste in mandibular~     lengthening surgery causes more complications as surgical site infections and hardware~     removal.~      An evaluation will be made to determine if the benefits of the use of the paste~     (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the~     disadvantages.~   "
10612|NCT02918331|"~     The purpose of this study is to evaluate the safety of daratumumab when combined with~     lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple~     myeloma who are not candidates for high-dose chemotherapy and autologous stem cell~     transplantation (ASCT).~   "
10613|NCT02918318|"~     The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine~     compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese~     participants with treatment-resistant depression (TRD), in improving depressive symptoms.~   "
10614|NCT02918305|"~     The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which~     aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise® in Europe)~     for renal denervation therapy in patients with treatment resistance hypertension, in~     comparison with the sham procedure.~   "
10615|NCT02918292|"~     This study is a prospective, simultaneous, parallel phase II study with one arm receiving~     unrelated cord blood transplantation and the other arm receiving haploidentical~     transplantation for Severe Aplastic Anemia (SAA) patients. The primary objective is to~     assess overall survival (OS) separately in the 2 arms at 1 year post-hematopoietic stem cell~     transplantation (HSCT).~   "
10616|NCT02918279|"~     This trial is conducted globally. The aim of this trial is to investigate the effect of~     liraglutide for weight management in pubertal adolescent subjects with obesity.~   "
10617|NCT02918266|"~     The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the~     attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning~     Test (GMLT) (total number of errors).~   "
10628|NCT02918123|"~     Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to~     severe in plaque-type psoriasis injection for 4weeks.~   "
10629|NCT02918110|"~     The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal~     slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.~   "
10858|NCT02915081|"~     The investigators hypothesize that subjects undergoing liver resection and who are exposed~     preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury,~     specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent~     light.~   "
10618|NCT02918253|"~     Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer,~     traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR)~     brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment~     schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence~     adverse effects including urinary, rectal, and sexual toxicities that affect the patient's~     quality of life.~      This study will incorporate HDR monotherapy treatment option for early stages and favourable~     risk prostate cancer.~      Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined~     disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing~     the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland~     therapy. Advantages in quality of life could be exhibited in the form of reduced urinary~     discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland~     function. This study would be particularly relevant in the current era of earlier localized~     prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine~     component of patient care.~   "
10619|NCT02918240|"~     Fixed orthodontic braces are routinely used to straighten teeth and correct the bite of~     individuals. Once the braces are fit, the patient is recalled every few weeks to adjust or~     tighten the brace. Although convention states that the patient returns every 6-8 weeks to~     have the brace adjusted, there is no consensus or evidence to support a specific timeframe.~     Indeed some orthodontist see their patients as frequently as every 4 weeks and others as~     long as every 10 weeks. The aim of this investigation is to determine whether the amount of~     time between brace adjustment appointments has an effect on the overall treatment time.~     Knowing which appointment interval will lead to the shortest overall treatment time will be~     of benefit to patients as prolonged orthodontic treatment may be associated with an~     increased incidence of adverse effects associated with orthodontic treatment.~      Patients who are to be treated with fixed orthodontic braces at will be invited to take part~     in the study. Consenting subjects will be randomly allocated into one of four groups. The~     first will be seen to adjust their brace every 4 weeks, the second group every 6 weeks, the~     third group every 8 weeks and the fourth group every 10 weeks.~      The primary outcome measure is the total treatment time. The mean treatment time of each of~     the four groups will be compared to establish whether or not treatment appointment intervals~     affects treatment time.~      Secondary outcome measures will include difference in number of appointments required~     throughout the course of treatment between groups, differences in treatment outcomes,~     differences in patient compliance.~   "
10620|NCT02918227|"~     Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia~     (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized~     what constitutes the main constraint for patients. Empirically, the investigators talk to~     the patient retrograde ejaculation to explain a possible loss of ejaculation. Yet the~     underlying mechanism of this modification or loss of ejaculation remains completely unknown.~     Yet the underlying mechanism of this modification or loss of ejaculation remains completely~     unknown. No study could not determine whether the predominant mechanism was a real~     retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to~     preserve antegrade ejaculation but no scientific rationale can not validate.~   "
10621|NCT02918214|"~     Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a~     left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume~     overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic~     dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its~     external validity is hampered by the numerous limits and the heterogeneity of the studies.~     To date, a pathophysiological link between LV diastolic dysfunction associated with septic~     shock and the water balance (reflecting volume overload) remains to establish. In addition,~     small size studies reported an excess of mortality in patients with septic shock who were~     diagnosed with a high cardiac output. However, no large cohort has yet confirmed the~     negative prognostic role of a hyperkinetic hemodynamic profile at the initial phase of~     septic shock.~   "
10622|NCT02918201|"~     After surgical procedures, interventions to reduce postoperative bleeding are of great~     importance. In this study, the effect will be investigated of administering tranexamic acid,~     which is designed for injection, directly onto the raw wound surface (topical application)~     created during surgery. In this way only a small amount of drug is to reach a large wound~     area. There will be a higher drug concentration of it in the exposed wound surface than~     after injection, but only a very low concentration in the body, and no risk of injury from~     needles. The researchers have recently shown that topically applicated tranexamic acid~     reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied~     whether topically applicated tranexamic acid reduces bleeding and wound effusions from~     superficial wounds, Now it will be studied whether topically applicated tranexamic acid~     reduces bleeding and wound effusions from superficial wounds, using as a study model the~     homogenous wounds created by tangential skin excision when harvesting split skin grafts for~     skin transplants. Two identical wound surfaces in the same patient will serve as case and~     control.~   "
10623|NCT02918188|"~     This study suggested that hydrogen has a potential as an effective and safe therapeutic~     agent on cGVHD.~   "
10624|NCT02918175|"~     The overall objective of this study is to test a personalized mHealth intervention designed~     to increase physical activity and improve medication adherence in subjects with heart~     failure and diabetes mellitus. The study will leverage consumer technology as both an~     intervention and as a tool for data collection.~   "
10625|NCT02918162|"~     To determine and evaluate the efficacy of combination therapy with immune checkpoint~     blockade and chemotherapy used in the perioperative period in eradicating micrometastatic~     disease.~      To compare paired tissue and serum samples (pre-treatment and post-treatment) from~     individually treated patients to explore the immune effects of combination therapy and~     predictors of response.~   "
10626|NCT02918149|"~     Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as~     a method to improve success but it is not known if it helps. This study is designed to see~     if ultrasound improves the success rate.~   "
11123|NCT02911597|"~     The primary objective is to determine if the opioid properties of ketamine are responsible~     for its antidepressant effects. Since naltrexone can block opiate actions, the investigators~     will determine if naltrexone can effectively block ketamine's effects.~   "
10630|NCT02918097|"~     To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD)~     using medications available in the Brazilian Public Healthcare System (SUS). Quality of life~     assessment of these patients was also employed.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of bipolar disorder depression episodes.~   "
10631|NCT02918084|"~     Breast cancer is the most common form of cancer among women. For patients candidated for~     adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been~     clearly defined yet.~   "
10632|NCT02918071|"~     The purpose of the study is to assess functionality, performance, and reliability of an~     single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an~     at-home setting reported by the patient or caregiver, and to confirm the safety and clinical~     benefit of benralizumab administration in asthma patients with severe asthma~   "
10633|NCT02918058|"~     Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among~     older adults and especially those classified as frail. ADEs are responsible for nearly~     27,000 hospital admissions in Canada annually. Within 30 days of discharge, medications~     contribute to two-thirds of adverse events, with nearly 60% being preventable or~     ameliorable. MedStopper is a Canadian Institutes of Health Research-funded software product~     that guides patients and physicians in the community through the process of deprescribing.~     MedStopper has been upgraded to a research application for the purposes of this study and~     now electronically cross-references patient comorbidities with the most recent~     evidence-based PIMs as of 2016, in order to generate a patient-tailored deprescribing care~     plan. This study will evaluate whether this application, when applied at hospitalization,~     leads to a reduction in the proportion of PIMs prescribed at 30 days post discharge, by~     highlighting harmful medications for deprescription to treating physicians. This study will~     take place on the clinical teaching units (CTUs) at four hospitals. Based on historical~     records, the investigators estimate enrolling 480 patients aged 65 or older over three~     months. A trained research assistant will identify eligible patients, and will enter their~     medications, comorbidities, and an estimate of frailty into MedStopper. A deprescribing plan~     will be generated for the CTU team containing rationale for suggested medication changes and~     strategies for safe and successful deprescription. The CTU team will then decide in~     conjunction with the patient or proxy, and with relevant consultants, which medications can~     rationally be stopped or tapered at discharge.~   "
10634|NCT02918045|"~     The purpose of this study is to compare two hemostatic agents in patients under dual~     antiplatelet therapy using the intraoral bleeding time after dental extractions.~   "
10635|NCT02918032|"~     This study aims to understand the state of onset of NLSD(neutral lipid storage disease) /~     TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected~     patients, and natural history of the disease, as well as exploring the prognostic factors~     and assessing the efficacy of disease-specific treatment.~   "
10636|NCT02918019|"~     This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm~     study will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo~     as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium-~     or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following~     additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier~     (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.~     The total duration of this study for each participant is approximately 70 weeks including~     screening, run-in, treatment, and follow-up.~   "
10637|NCT02918006|"~     A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009~     (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based~     Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.~   "
10638|NCT02917993|"~     The purpose of this study is to evaluate the safety and tolerability of INCB039110 in~     combination with osimertinib in subjects with locally advanced or metastatic non-small cell~     lung cancer (NSCLC).~   "
10639|NCT02917980|"~     This project aimed to optimize the therapeutic strategy for structural heart disease by~     choosing optimal treatment, such as,surgical treatment,interventional and surgery combined~     with interventional hybrid treatment. Thereby improve successful rate of clinical treatment,~     and establish the guideline for treatment of structural heart disease.At the same~     time,online registration database for structural heart disease will be established to~     further data analysis and objective assessment of clinical curative effect for structural~     heart disease in China.~   "
10640|NCT02917967|"~     This is a longitudinal, prospective, and open-label interventional study in a single center.~     We will investigate the effect of single injection in each patient. This study was designed~     to establish the clinical evidence for effect of botulinum toxin type a (Dysport,~     abobotulinum toxin A) injection on changes in musculotendinous length and dynamics of~     hamstring muscles during gait in children with spastic cerebral palsy walking with excessive~     knee flexion.~      Baseline data such as Modified Ashworth scale (MAS), Modified Tardieu scale (MTS), Gross~     Motor Function Measures (GMFM), and Gross Motor Function Classification System (GMFCS) level~     will be assessed. Gait analysis will be performed using a computerized gait analysis system~     (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure~     the kinematic data (angle of each joint) during the gait cycle. A trained investigator will~     place 14 reflective markers on the anterior and posterior superior iliac spine, the mid~     points of the lateral femur, the lateral knee joint axis, the midpoints of the lateral~     tibia, the lateral malleolus, and the dorsal foot between metatarsal heads 2 and 3. All~     subjects should walk barefoot at a self-selected speed along an 8-meter path with the~     markers in place and the motion will be captured with a 100-Hz sampling frequency.~     Force-plates (AMTI OR 6-5, Advanced Mechanical Technology, Newton, MA, USA) under the path~     will record ground reaction forces during the walking trials with a 1000-Hz sampling~     frequency, and joint moments will be expressed as internal moments to counter the ground~     reaction forces. Data collection will continue until the subject achieved at least 3 'clean'~     force-plate strikes. Kinematic and kinetic data from successful trials will be used for~     statistical analysis. Video recording will be done simultaneously from the front, rear, and~     side, with the 3D gait analysis.~   "
10663|NCT02917668|"~     This study aims to evaluate the risk of hyperoxia-induced hypercapnia in post-op obese~     cardiac surgery patients. It will compare two oxygenation modes in terms of their effect on~     the arterial partial pressure of carbon dioxide (PaCO2) : manual titration of oxygen~     delivery for a peripheral oxygen saturation (SpO2) target of > 95 % versus automatic~     titration by a closed-loop system for a SpO2 target of 90%. 15 post-op obese cardiac surgery~     patients will be recruited and each will receive both interventions (cross-over design). The~     main outcome will be the PaCO2, which will be compared after each study period. The research~     hypothesis is that the usual SpO2 target of > 95 % is associated with a greater PaCO2~     compared with a lesser SpO2 target of 90%.~   "
10641|NCT02917954|"~     Canadian and international health care systems require solutions on how to address the needs~     of a relatively small population that take up a large portion of health care resources. In~     Ontario, 10% of the population accounts for 79% of total system costs, with similar trends~     found in other parts of Canada and internationally. Most high-cost users are seniors, older~     adults, with multiple chronic conditions and complex care needs who are living in the~     community. Beyond the cost issues, older adults experiencing multi-morbidity are at~     higher-risk of poor health outcomes and experience lower quality of life as compared to~     individuals experiencing single illness only.~      Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and~     portal, has undergone a multi-phased, user-centred design evaluation approach to develop a~     tool designed to meet the needs of older adults with complex care needs and their primary~     care providers. The ePRO tool is designed to collect person-centred, person-reported~     indicators to improve care by supporting primary care delivery and enhancing patient~     self-management.~      The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal~     Tracker allows patients and providers to collaboratively create goal-oriented patient~     care-plans, and helps patients to track outcomes related to their goals using a mobile~     device. The Health Journal allows patients, their caregivers and primary care providers to~     monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified~     following each previous study phase (I-IV). This project marks the final phase of the study~     in which the investigators will conduct a pragmatic trial of the ePRO tool in 22 Family~     Health Teams in Ontario through a cluster randomized control trial with an embedded case~     study. In this evaluation of the tool the investigators will assess outcome, process and~     context measures to identify how the tool affects patients, providers and the system at~     point-of-care.~   "
10642|NCT02917941|"~     The purpose of this study is to evaluate the efficacy and safety of ixazomib plus~     lenalidomide and dexamethasone in Japanese patients with relapsed and/or refractory multiple~     myeloma.~   "
10643|NCT02917928|"~     The investigators hypothesise that carnosine supplementation will improve:~        1. glycaemic control~        2. cardiovascular risk factors~        3. cognitive outcomes~      in patients with impaired glucose tolerance and type 2 diabetes, and this will be modulated~     by reduction in chronic low grade inflammation, oxidative stress and circulating advanced~     glycation end products levels.~      3. Aims~      To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic~     control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve~     cognitive function as well as identify metabolic pathways involved, specifically by:~        1. Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under~          the curve after oral glucose tolerance test)~        2. Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central~          blood pressure (cBP); endothelial function).~        3. Improve cognitive function (global cognitive score formed by a composite of 4 cognitive~          tests)~        4. Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end~          products, and advanced lipoxidation end products, and increase detoxification of~          reactive carbonyl species (RCSs).~   "
10644|NCT02917915|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and~     comprehensive intervention for COPD patients that includes patient assessment, exercise~     training, and self-management education to promote behavior changes. PR has been shown to be~     the most effective strategy to improve clinical health outcomes, and is now considered to be~     a standard of care intervention for individuals with COPD who remain symptomatic despite~     optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at~     enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD~     management (i.e., physical activity, medication adherence, self-managing exacerbations).~      In collaboration with the local clinical staff as well as national colleagues and the~     Canadian Thoracic Society, a new national pulmonary rehabilitation program has been~     co-developed that is designed to increase physical activity, medication adherence, and~     skills to help manage chronic lung diseases. The new program aims to increase people's~     confidence and autonomy for performing disease-management behaviors, and has been designed~     to be more effective at increasing physical activity, medication adherence, and disease~     management skills than previous pulmonary rehabilitation programs. The program is designed~     to be delivered within different settings of practice, including traditional PR centers,~     satellite sites (i.e., sites that are remote from the major institutions),with the use of~     Tele-health and web-based resources, and primary care medical centers. The effectiveness of~     the new Standardized Canadian PR program will be assessed relative to the traditional PR~     program. This trial is an important step towards establishing the necessary evidence that~     will then enable us to work on dissemination and implementation of this new standardized PR~     program across the country.~   "
10645|NCT02917902|"~     To compare the effectiveness of providing monthly boxes of nutritious foods to low-income~     patients with diabetes on site at Free Clinics with referrals to off-site food pantries on~     diabetes related health outcomes~   "
10646|NCT02917889|"~     Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory~     parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery~     of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.~   "
10647|NCT02917876|"~     This study seeks to understand the physical, physiologic and biologic features that~     predispose a woman to the development of obstructive sleep apnea once they are exposed to~     the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific~     predictive factors can help identify a population at risk and guide clinicians to develop~     suitable targeting screening strategies.~   "
10648|NCT02917863|"~     Thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal~     impairment, such as celiac disease. A study reported an increased prevalence of celiac~     disease in a large cohort of children affected by congenital hypothyroidism, underlying the~     relationship between these two conditions. The hypothesis of our study is that the onset of~     celiac disorder may be related to the gut concentration of thyroid hormone (TH) in~     hypothyroidism patients treated with replacement therapy. In fact, TH replacement therapy~     showed a low bioavailability with a consequent high gut concentration. Two different~     pharmaceutical formulations (liquid and solid, per os) are available. The liquid one has a~     better absorption profile and bioavailability than the solid; therefore, it is associated~     with a low TH intestinal concentration. According to our hypothesis, the solid TH~     formulation could increase the microbial diversity in the gut instead of the liquid form,~     due to the high local TH concentration. Based on these findings, the purpose of this study~     is to evaluate the effect of two different pharmaceutical formulations of TH on the gut in~     terms of modification of gut microbiota, inflammatory parameters and gut absorption.~   "
10649|NCT02917850|"~     Post-stroke patients often present with gait disorders due to several physical impairments.~     Hip flexor deficit is one of the more prevalent trouble and is associated with gait~     capacities. This study aims at evaluating the impact of an isokinetic hip flexors~     strengthening rehabilitation program in the subacute phase after stroke. Patients will be~     randomized to an intervention group (isokinetic rehabilitation) or a control group~     (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3~     and at 6 months.~   "
10684|NCT02917395|"~     Population study- patients with obstructive hypertrophic cardiomyopathy that are treated~     with disopyramide.~      Tow echo examination, few hours apart, that includes strain rate will be done to each~     patient. The first, after taking the regular medical treatment excluding disopyramide and~     the last one after taking the disopyramide.~   "
10650|NCT02917837|"~     Diagnostic imaging (DI) tests (for example, x-ray tests, ultrasounds, CT scans, or MRIs) are~     used by health care providers to help diagnose patient illness, but decisions regarding when~     these tests should be ordered are subjective. As a result, some physicians order these tests~     more than others. Ordering rates between clinicians seeing similar kinds of patients have~     been shown to be considerably different, suggesting that many of the tests are unnecessary.~     DI currently accounts for about 6.6% of Canadian hospital budgets, but this percentage may~     be much higher in Newfoundland where test ordering rates are almost twice the national~     average. However, cost is not the only concern. Over-testing can lead to further unnecessary~     testing to follow-up on harmless findings, and in the case of CT, large doses of potentially~     harmful radiation. The purpose of this study is to assess DI test-ordering by family~     physicians across the Eastern Health region, and compare these test ordering rates with~     those from other jurisdictions. We suspect that many clinicians are not aware that they~     order more DI tests than their peers. We will therefore develop a report card for family~     physicians in the province that shows them how many tests they are ordering compared to~     other physicians in the region. We expect that physicians who are over-ordering DI tests~     will reduce the number of tests they order after receiving their report cards. This is a~     low-cost way to potentially prevent expensive over-ordering of DI tests that can easily be~     implemented in the province's other health regions and elsewhere.~   "
10651|NCT02917824|"~     Inspiratory muscle training (IMT) can reverse or delay the complications from the~     deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a~     treatment option for people with asthma. The aim of this study is to investigate the~     training principles of intensity, specificity and reversibility of IMT in asthmatics.~   "
10652|NCT02917811|"~     The aim of this study is to verify if high values of RDW are useful prognostic marker for~     ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of~     RDW in specific subgroup population with some clinical characteristic wich may modify RDW~     baseline values, i.e. transfused patients or patients with high markers of hemolysis~   "
10653|NCT02917798|"~     This study will evaluate patients' experiences with having gynecologic medical oncologists~     and surgeons offer them genetic testing, and having genetic counselors return the test~     results to patients over the telephone. This is different from the usual approach to genetic~     testing, where gynecologic medical oncologists and surgeons refer their patients to a~     genetic counselor in order to have these tests done, and the genetic counselors return the~     test results to the patient in person or over the telephone. The investigators will only be~     evaluating this alternative way of providing genetic testing to ovarian cancer patients.~   "
10654|NCT02917785|"~     the purpose of this study is to examine the success rates of Karman curettage in completing~     the abortion after failed recurred treatment with Misoprostol for women with missed~     abortion.~   "
10655|NCT02917772|"~     TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional~     nivolumab/ipilimumab boost cycles in previously untreated and pretreated (2nd line),~     advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk~     disease according to IMDC.~   "
10656|NCT02917759|"~     Patients having surgery to remove a liver or biliary tissue mass will have a tissue sample~     collected and stored for future research. A blood sample may also be collected at the time~     of enrollment.~   "
10657|NCT02917746|"~     This multi-center, open-label, non-randomized controlled intervention study aims to~     investigate the treatment efficacy, side-effects and quality of life associated with~     imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by~     Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent~     side-effects associated with surgical treatment, such as premature birth in subsequent~     pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN~     will be adequately treated with imiquimod.~      120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to~     one of two treatment arms according to their preference:~        1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal~          imiquimod 5% cream during 16 weeks.~        2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ~          treatment.~   "
10658|NCT02917733|"~     This type of study is called a radiolabeled study. For this study, LY3039478 (study drug)~     has been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally~     occurring radioactive form of the element carbon. This study will help determine how the~     drug appears in the blood, urine, and stool after it is administered by mouth to healthy~     people. Information about any side effects that may occur will also be collected. This study~     will last about 10 weeks for each participant.~   "
10659|NCT02917720|"~     The main goal of the study is the assessment of duration of major molecular response (MMR)~     or better at 12 and 36 months after stopping tyrosine kinase inhibitors (TKI) therapy a~     second time in patients with at least three years prior TKI treatment comprising at least~     two years of nilotinib treatment within this trial and maintained stable MR4 (BCR-ABL ratio~     <0,01% on international Scale (IS) for at least one year and MR4.5 (BCR-ABL ratio <0,0032%~     on IS) for at least 6 months:~        -  who failed a first stop in the EURO-SKI study (standardized criteria)~        -  who failed a first stop outside the EURO-SKI study but would have had fulfilled same~          eligible criteria and were stopped according to EURO-SKI rules~        -  who failed a first stop outside the EURO-SKI study without fulfilling EURO-SKI rules~   "
10660|NCT02917707|"~     The investigators will perform integrative analysis of CRC liver metastasis~   "
10661|NCT02917694|"~     This study aims to assess the feasibility of obtaining details about a patients previous~     level of function from the patient of friend/relative, after they have been admitted an~     intensive care unit (ICU). It will also assess the feasibility of re-assessing level of~     function at 6 months after the patient has been discharged from ICU.~   "
10662|NCT02917681|"~     The study aims to evaluate primarily safety of two injections of autologous mesenchymal stem~     cells in Amyotrophic Lateral Sclerosis patients. Secondary outcomes of efficacy will also be~     evaluated~   "
10810|NCT02915822|"~     The aim of this study is to assess the feasibility of conducting a study to compare the~     patient recorded and clinical outcomes for the surgical management of Hallux Valgus~     correction. A prospective trial will randomise the patients into two groups - Open~     Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy.~   "
10664|NCT02917655|"~     BACKGROUND: Osteoarthritis (OA), and particularly knee osteoarthritis (KOA) is a disorder~     that greatly impairs the quality of life of patients and its incidence increases with~     longevity, obesity and lower socioeconomic and educational level. It is expected that 40% of~     people over 60 have symptomatic OA of the knees and hips. The core treatment of OA is~     education, weight loss and increased physical activity. We create an educational program~     that improved function of the patients given by the five-times-sit-to- stand test (FTSST).~     However, weight loss, an important foundation of clinical treatment, was only effective~     (more than 2 points in BMI) in 10% of the program participants. For greater effectiveness in~     weight loss and adherence to physical activity, we prepared an intensive program with more~     intensive nutritional care, psychological, physical therapy and physical trainers and~     compare the existing program educators. OBJECTIVE: To compare an educational program~     isolated to an educational program associated with nutritional consultations, group therapy~     sessions and progressed physiotherapy sessions to sessions with physical educators in~     patients with KOA and comorbidities (metabolic syndrome).~      METHODS: Ninety patients with OAJ and co-morbidities (Two or more of: overweight or obesity,~     hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two~     groups: study (S) and control (C). Both groups will attend the two-day multi-professional~     classes on OA with two months interval. But the study group will also make three group~     consultations about nutrition, 1 extra session of group therapy with psychology team and 7~     exercise sessions in groups with physical therapy and subsequently 7 sessions with physical~     educators. The groups will be evaluated for weight, height (to calculate BMI), waist-hip~     ratio, percentage of body fat, consumption of daily medications, WOMAC, Lequesne, IPAQ,~     Tampa Scale for Kinesiophobia (TSK), test sits and rises, timed-up- and-go (TUG) and six~     minute test. At inclusion, six, twelve and 24 months after the classes.~   "
10665|NCT02917642|"~     The purpose of this clinical study was to compare the effectiveness of passive ultrasonic~     irrigation with that of traditional syringe irrigation on the removal of bacteria and~     endotoxin (lipopolysaccharide [LPS]) from root canals.~   "
10666|NCT02917629|"~     This randomized phase IIb trial studies how well ACTOplus met XR works in treating in~     patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive~     treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from~     forming or coming back. The use of ACTOplus met XR may slow disease progression in patients~     with oral cavity or oropharynx cancer.~   "
10667|NCT02917616|"~     This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on~     the gut microbiota of healthy male volunteers.~   "
10668|NCT02917603|"~     Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has~     found the quality of care of end-of-life care in nursing homes to have many challenges. It~     has also been documented that family members, especially those living at a distance, want to~     be involved in the care of their resident and family support can be beneficial to residents.~     Family members' involvement in decision-making in the nursing home setting improves outcomes~     for residents with life-limiting illnesses. Shared decision-making is a process wherein a~     healthcare choice is jointly made by a healthcare provider and a resident or resident's~     proxy, often a family member. This proposal seeks to facilitate SDM among family members,~     residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing~     home care team. The overall research question (RQ) asks: To what extent are outcomes for~     family member and residents with life limiting illnesses associated with SDM via~     web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family~     members, residents (when possible), and skilled nursing home staff via web-conferencing will~     improve outcomes for family members and residents with life-limiting illnesses. This is an~     exploratory mixed methods randomized clinical trial pilot to test the effect of shared~     decision making using web-based conferencing on the depression and burden of family members~     and the pain of nursing home residents.~   "
10669|NCT02917590|"~     Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing~     training on the improvement of walking ability, balance ability, and lower extremity muscle~     strength in ambulatory subjects with spinal cord injury~   "
10670|NCT02917577|"~     The study is a prospective, single centre, double-blinded randomized controlled trial whose~     goal is to compare the immune response of a population of immunosuppressed pediatric~     rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A~     vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts,~     have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity~     of two different dosing options of vaccine for this age group after one and two doses. A~     total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions~     for which they are being treated with an immunosuppressive therapy will be recruited from~     the Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no~     immunity to hepatitis A will be enrolled. Informed, written consent will be obtained from~     the parent or guardian of subject, with assent obtained from the study subjects. Subjects~     will be randomly assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult)~     vaccine (Sanofi Pasteur Canada), six months apart, with hepatitis A titres done at baseline~     and one month after each dose. Both formulations are licensed for this age group.~   "
10671|NCT02917564|"~     During glaucoma surgery, a new opening is created that allows fluid to drain out of the eye,~     bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma.~     In some patients who have had glaucoma surgery too much fluid flows out and this results in~     a pressure that is too low. This may cause swelling of one layer at the back of the eye~     called the choroid. The formation of this swelling, called a choroidal effusion or~     choroidal, often makes the eye pressure stay too low, and one of the results is a decrease~     in vision. The treatment for a choroidal effusion is to try to raise the eye pressure~     somewhat to allow the swelling to subside. In our clinical work, we have found that an~     injection with an anti-inflammatory drug called triamcinolone appears to be helpful in~     speeding up healing. We plan to compare two groups of patients with choroidal effusions, one~     group that gets an injection of triamcinolone and one that gets a sham treatment with~     nothing injected and compare the length of time it takes the choroidal effusions to~     disappear. Both groups receive the standard treatment with eye drops. We will also assess~     the outcome of the glaucoma surgery and any other complications that may occur. This~     research is aimed at studying a new method of improving the outcomes of surgery for glaucoma~     patients, and further the treatment of glaucoma.~   "
10707|NCT02915458|"~     Making a weaning decision for a patient on a mechanical ventilator is an important clinical~     issue. The most common index to predict successful weaning is the rapid shallow breathing~     index (RSBI), however, the accuracy of RSBI to predict successful weaning have been~     questioned.~      The investigators proposed a new mathematical model and algorithm, called WIN, which capture~     the essential feature of the variability ruling the physiological dynamics to provides~     better perdition to wean than RSBI.~   "
10672|NCT02917551|"~     The burden of bloodstream infections is large and increasing over time. Antibiotic overuse~     continues to drive increased rates of antimicrobial-resistant pathogens across Canada.~     However, prospective audits have revealed that 30-50% of antibiotic utilization is~     unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration~     therapy for these infections, antimicrobial consumption would be decreased. A pilot trial~     (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients~     at 17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect~     to protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a~     similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream~     infections to determine feasibility and protocol adherence of the same trial protocol.~   "
10673|NCT02917538|"~     A clinical randomized trial to evaluate if CF guided Radio Frequency Ablation (RFA) to a~     specific of LSI in atrial flutter i superior to standard RFA.~   "
10674|NCT02917525|"~     Early development of calcified aortic valve disease (CAVD) is a commonly occurring~     complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of~     two leaflets instead of three). In general, CAVD is characterized by progressive narrowing~     of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in~     fact may lead to necessity of valve replacement, since to date, no other therapies have been~     shown effective in the treatment of CAVD.~      The primary objective of our study is to test the hypothesis that supplementation of vitamin~     K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation~     of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of~     calcification.~      In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2~     or placebo group. To assess the calcification process in a detailed manner in these~     patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF])~     that has been shown to bind to regions of newly developing microcalcification in aortic~     valve tissue is used.~      We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic~     valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the~     calcium score on CT and echocardiography after 18 months (secondary endpoints), when~     compared to placebo.~   "
10675|NCT02917512|"~     A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II~     Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with~     Dry Eye Syndrome~   "
10676|NCT02917499|"~     The goal of this study is to examine the efficacy and safety of transcranial magnetic~     stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and~     neurological disorders. Subjects will be randomized into two groups: experimental (treated~     with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They~     and their clinicians will complete a battery of instruments that measure relevant symptoms,~     global functioning and quality of life. The first measurement will be done after the~     inclusion and before treatment. The second measurement will be made immediately after the~     end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3~     and 6 months.~   "
10677|NCT02917486|"~     The objective of the study is to investigate the exposure difference between antibiotic~     studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients~     without Extracorporeal Membrane Oxygenation.~      The exhibition is evaluated by population pharmacokinetic modeling.~   "
10678|NCT02917473|"~     First-degree relatives of patients with melanoma have a greater risk of developing melanoma.~     Patients are advised orally to inform their first-degree relatives that they should protect~     their skin from UV radiation and ask for a skin examination from a general practitioner or~     dermatologist. The study will evaluate the effectiveness of a written sheet in addition to~     the usual oral counselling to increase acceptance of skin examination by the first-degree~     relatives. If effective, written counselling provided to the patient for relatives should be~     recommended and generalized.~   "
10679|NCT02917460|"~     Rady Children's Institute for Genomic Medicine (RCI) will collect biological samples (such~     as blood), derived genomic sequences (from DNA and RNA), and clinical features in a~     Biorepository as a standardized resource for future research studies. The purpose of the~     Genomic Institute Biorepository is to provide consented samples and data for basic and~     clinical research related to the genomic cause and treatment of childhood disease, and, in~     the future, as reference (Quality Control) data to improve the ability to make clinical~     diagnoses or clinical decisions.~      In addition, the Biorepository will provide a mechanism for making a diagnosis of a genetic~     disease. That is, once genomic sequences have been derived from biological samples, they~     will be immediately analyzed. If a genetic disease is identified that appears to explain an~     affected child's clinical features, then those results will be confirmed by the medically~     accepted standard, and placed in the electronic health record.~   "
10680|NCT02917447|"~     The purpose of this study is to evaluate an online PTSD intervention that was adapted for~     women Veterans, called DElivery of Self TRaining and Education for Stressful~     Situations-Women Veterans version (DESTRESS-WV). The intervention consists of structured~     online sessions as well as weekly brief phone calls for additional support with a study~     coach. Women Veterans with PTSD who are eligible will be randomized to receive either~     DESTRESS-WV or phone monitoring only for 8 weeks. Participants will be assessed immediately~     post-treatment as well as at 12 and 24 weeks post-treatment. Investigators hypothesize that~     participants randomly assigned to DESTRESS-WV will have a greater decrease in severity of~     PTSD symptoms compared to those randomly assigned to phone monitoring only.~   "
10681|NCT02917434|"~     The study is an open intervention study with the aim to determine the effects of weight-loss~     treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers~     of the metabolic syndrome in patients with psoriatic arthritis and obesity.~   "
10682|NCT02917421|"~     This protocol is for patients with newly diagnosed breast cancer with an indication for~     post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.~   "
10683|NCT02917408|"~     Retrospective study of all patients diagnosed with primary biliary cholangitis during~     January 2001 to July 2016 at West China Hospital by review of medical records. The following~     variables will be retrospectively studied: age, sex, first symptoms, clinical~     characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune~     diseases and long-term outcome.~   "
10685|NCT02917382|"~     Liver transplantation (LTx) is the standard treatment used in the final stage of chronic or~     acute liver failure. The success for the LT depends on many factors. One of the factors~     related to morbidity and mortality of these patients is malnutrition. Patients on the~     waiting list for LTx are increased risk of malnutrition and metabolic disorders that may be~     associated with decreased functional capacity, change in resting energy expenditure cardiac~     autonomic dysfunction. These conditions may influence the results both before and after~     transplantation, as the clinical outcome and complications present in the postoperative~     period. Therefore, this study aims to characterize and relate nutritional status, metabolic,~     functional and clinical outcomes in the recent postoperative patients undergoing liver~     transplantation. It is an observational, prospective study based on four evaluations: the~     first will be conducted while the patient is awaiting transplantation; and after insertion~     of the graft, patients will be evaluated between the 1nd and 3th postoperative day, between~     5 and 7 days and at discharge from hospital.~      In the late post-transplant, there is the action of immunosuppressive drugs, largely~     responsible for increased survival, but also on the other hand, are responsible for~     important nutritional and metabolic disorders. Metabolic complications such as hyperkalemia,~     hypertension, diabetes mellitus and overweight have been described. Thus, due to the high~     incidence of these complications, alternative options, such as lowering the dose of~     immunosuppressive drugs, have been fully explored, particularly as regards association with~     the viability of the graft. However, few studies have evaluated whether there is change in~     the incidence of metabolic disorders, cited above, in relation to the different doses of~     immunosuppressive drugs. Furthermore these metabolic complications will be evaluated in the~     late post-transplant period.~   "
10686|NCT02917369|"~     Integrative analysis of LCLC~   "
10687|NCT02917356|"~     Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well~     as the main cause of pain and disability in older persons worldwide. The limited results of~     physical therapy in OA makes OA patients potential candidates for complementary therapies,~     such as laying on of hands. The present study aims to investigate the effect of Laying on of~     Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee~     Osteoarthritis. This is a randomized controlled trial with three allocation groups:~     spiritual laying on of hands (passe espiríta - Spiritist passe/spiritual healing) (SP),~     non-spiritual laying on of hands (LH) and Control Group without laying on of hands (CG). All~     subjects will participate in a 45-minute kinesiotherapy program. After that, groups will be~     directed to the 5-minute session of laying on of hands according to their groups. During the~     application of SP, LH and CG, the subjects will remain in a sitting position, blindfolded~     with dark goggles, and receive the following verbal command: Relax and calm your mind. The~     intervention will happen twice a week for eight weeks and a blinded physical therapist will~     assess the pre and post scores of pain, functionality, joint stiffness (through WOMAC and~     visual analogic scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality~     (FACIT Sp12) and quality of life (WHOQOL-Bref), among other secondary outcomes.~   "
10688|NCT02917343|"~     The purpose of the study is to determine the effect of a combined mirror therapy and task~     oriented/repetitive task training on upper extremity function of persons with hemiplegia due~     to cerebrovascular accident or stroke.~   "
10689|NCT02917330|"~     The purpose of this randomized and controlled intervention study is to explore the effect of~     a physiotherapy intervention targeting contract and spastic hamstring muscles in children~     having bilateral spastic cerebral palsy (CP), GMFCS I-III: A stretching routine targeting~     hamstrings (and psoas if short), and a progressive strengthening program on the muscles~     extending then lower extremities (quadriceps, gluteus maximus and triceps surae)~      Study hypothesis: Stretching of hamstrings and strength training of the extending muscles in~     the lower extremities in children with bilateral spastic cerebral palsy will increase~     popliteal angle, active knee extension, and gait function.~   "
10690|NCT02917317|"~     To investigate biomarkers in prediction of cardiometabolic and other diseases of adults aged~     20-60 years.~   "
10691|NCT02917304|"~     The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among~     healthy adults over 65 years of age.~   "
10692|NCT02917291|"~     The main objective of the study is the evaluation of the safety and tolerability of~     FAB117-HC - a medicinal product containing human allogeneic adipose derived adult~     mesenchymal stem cells expanded and pulsed with H2O2 (HC016 cells ) - administered at a~     single-time point to patients with acute thoracic traumatic spinal cord injury (SCI). The~     study will also include initial exploration of potential clinical efficacy. Dose levels of~     20 million and 40 million cells will be administered.~   "
10693|NCT02917278|"~     This pilot study aims to produce preliminary data on the safety of providing high-protein~     meals to patients during dialysis, and effects of this intervention on nutritional status~     and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided~     will follow recommended dietary guidelines for HD patients and will provide approximately~     1/3 of daily recommended protein intake. Patients will be allocated to either the treatment~     or control group by HD shift schedule. 2 months of baseline data will be collected, followed~     by 9 weeks of meal intervention/control and data collection. The primary outcome will be~     frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes~     will include highest and lowest systolic blood pressure during dialysis, blood~     biochemistries including measures of renal function, nutritional status, and electrolyte~     balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and~     dietary intake data.~   "
10694|NCT02916667|"~     Working hypothesis and aims:~      To asses Chrono Biological factors during the third trimester of gestational diabetes~     melittus (GDM) with birth weight and related complications. The investigators hypothesize~     that participants with GDM pregnancies with higher Chrono Biologocal status will be ended~     with higher birth weight compared to participants with GDM pregnancies with lower status. In~     addition, the investigators hypothesize that the Chrono Nutritional intervention program~     will contribute to the reduction of the rate of birth weight above percentile 90 compared~     with the participants with GDM in the control group.~   "
10695|NCT02916654|"~     Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a~     phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which~     shows a high gastrointestinal absorption and high bioavailability with a low incidence of~     side effects due to lack of any direct contact with intestinal mucosa. In comparison with~     the other standard oral iron preparations, sucrosomial iron seems to be a promising new~     strategy of iron replacement in CD patients.~   "
10749|NCT02916732|"~     The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the~     Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and~     paraclinical data for the evaluation of potential complications due to having ZIKV infection~     during pregnancy. This study is meant to collect, within usual care practices, clinical and~     paraclinical information which will allow the precise description of the consequences of~     ZIKV infection occurring during pregnancy.~   "
10696|NCT02916641|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation However, about 40% of~     patients do not respond to UDCA optimally as assessed by known criteria for biochemical~     response. Those patients represent the group in need for additional therapies, having~     increased risk of disease progression and decreased survival free of liver transplantation.~     And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might~     jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver~     fibrosis and cirrhosis. Both lab research and some clinical studies suggest that~     Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind~     of etiology. Here we start a random, open and parallel clinical research to explore the~     effect of Fuzhenghuayu combined with UDCA in the PBC treatment.~   "
10697|NCT02916628|"~     Objective The purpose of this study is to examine the effects of auricular acupressure and~     group counseling with positive psychology and motivational interviewing on smoking cessation~     and tobacco withdrawal symptoms.~      Methods This study is a single blind randomized controlled trial. This study has been~     performed at a University in South Korea. 180 smokers and 60 non-smokers will be recruited.~     Smokers will be randomly assigned to three groups: group 1 (auricular acupressure + group~     counseling); group 2 (placebo acupressure + group counseling); and the control group~     (self-help smoking cessation). Group counseling is undertaken once per week for 6 weeks.~     Auricular acupressure using acupellets is performed for 6 weeks continuously.~   "
10698|NCT02916615|"~     The purpose of this study is to examine the effect of different vegetables on cardiovascular~     function in subjects with moderately increased blood pressure. Specifically we are comparing~     the effects of vegetables with a high natural content of inorganic nitrate with those of~     vegetables with a low nitrate content.~   "
10699|NCT02916602|"~     A phase 3 study to evaluate efficacy and safety of HCP1401~   "
10700|NCT02916589|"~     Obesity continues to pose major public health challenges worldwide with cardiovascular~     damage, hypertension and diabetes as possible subsequent conditions. The obese are at risk~     for mortality and morbidity as they suffer from a high level of immune sensitivity with~     consequences related to damage to the circulation and microvasculature. The immune process~     itself is modulated by cytokines, which are small proteins which can modulate the spectrum~     of the inflammatory process. These proteins may act as biomarkers in the mouth.~      Diabetes is also a consequence of sustained obesity and this condition can strongly~     influence immune status. Diabetes is characterized by the failure to produce the hormone~     insulin or a loss of sensitivity to insulin. Without insulin high blood glucose results in~     the release of a series of pro-inflammatory factors, which lead to pathological processes in~     several organs leading to high mortality and morbidity. Periodontitis, a common complication~     of diabetes, is an inflammatory condition of the soft tissue of the periodontium, causing~     alveolar bone loss. The accessibility of the oral cavity facilitates the study of early~     inflammatory processes.~      Changes in diet may reduce inflammation, controlling gingival inflammation as well as~     clinical treatment. Since 2004 Igelösa Life Science AB has developed a modified Nordic diet~     based on evidence, primarily from the Japanese island of Okinawa, where the world's oldest~     and most healthy people live. In this study we will investigate the association between~     Igelösa dietary intake and measurements of inflammation in 30 overweight individuals with or~     without other systemic diseases.~   "
10701|NCT02916576|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour Plus One (Ascensia Diabetes Care GmbH),~     Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes~     Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO~     15197:2015, clause 8.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed~     by study personnel (with the same reagent system lot used by subjects).~   "
10702|NCT02915523|"~     The purpose of this study is to determine the biologically active dose of entinostat, when~     given in combination with avelumab, that is safe and warrants further investigation.~     Additionally, this study will evaluate the effectiveness of entinostat in combination with~     avelumab at the determined dose in terms of progression free survival compared to avelumab~     plus placebo in patients with refractory or recurrent epithelial ovarian cancer.~   "
10703|NCT02915510|"~     This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and~     compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria~     (PKU).~   "
10704|NCT02915497|"~     The objective of this study is to assess the feasibility and effectiveness of AEPET plus~     Resilience Based Therapy (RBT) versus RBT alone for the prevention of PTSD and depression in~     trauma patients. The intervention group who have AEPET plus RBT will have reduced level of~     post traumatic stress symptoms and depression post sessions as well as reduced symptoms of~     PTSD and depression at 4- 6 weeks as compared to the control group who have -Resilience~     Based less specific supportive therapy.~   "
10705|NCT02915484|"~     The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct~     Current Stimulation) on apathy in stroke patients.~   "
10706|NCT02915471|"~     The overall aim of this research program is to develop and examine the impact of a Cancer~     virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in~     adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the~     Skype-based VP2P program providing peer-support from mentors and the magnitude of program~     effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT~     will enable us to refine the program and determine the appropriate sample size for a future~     large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at~     a major Children's Oncology Group- affiliated centers in Canada and the United States.~   "
10811|NCT02915809|"~     The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus~     GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.~   "
10708|NCT02915445|"~     This study is for patients that have nasopharyngeal carcinoma or breast cancer. As~     epithelial cell adhesion molecule (EpCAM) is a well characterized molecule that is closely~     with poor prognosis and tumor metastasis and invasion. Many therapies targeting EpCAM have~     shown benefits for cancer patients. This study is to determine the safety of the engineered~     T cells armed with chimeric antigen receptor (CAR-T) recognizing EpCAM. At the same time,~     efficacy is to be evaluated by the criteria of RECIST. The EpCAM CAR-T were produced by~     lentiviral transduction of the 3rd generation of CAR genes. Different cohorts of patients~     receive EpCAM CAR-T with a dose-escalating manner. This study is to find the largest dose of~     EpCAM CAR-T, to learn what the adverse effects are and to find out whether this experimental~     intervention might help patients with nasopharyngeal carcinoma or breast cancer.~   "
10709|NCT02915432|"~     The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant~     Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric~     adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and~     neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D)~   "
10710|NCT02915419|"~     This study aims to compare the ability of different regenerative protocols in the treatment~     of mature necrotic~   "
10711|NCT02917252|"~     This study evaluate the metabolic effects of orally ingested ketone bodies. The study is~     conducted as a randomized, cross over study.~   "
10712|NCT02917239|"~     Overall survival of multiple myeloma (MM) patients has increased significantly due to the~     availability of the new drugs. Moreover, since MM is an incurable disease, patients are~     exposed to repeated lines of therapy with different agents. It is therefore increasingly~     important to monitor the long-term side-effects of treatments. In the present study we~     focused on ocular disorders. This is an observational study aiming to assess the prevalence~     of ocular disorders in 100 patients on treatment or follow-up for MM.~   "
10713|NCT02917226|"~     The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web~     and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases~     screening, diagnosis, treatment and monitoring for the use of physicians and patients in~     primary care and to determine the effectiveness of the system. For validating the CDSMS for~     diabetes patients, randomized controlled trial will be conducted.A parallel single blind~     randomized controlled trial will be implemented. 10 physicians and their 439 patients are~     involved in the study. According to the results of screening which is done using developed~     CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by~     the physicians. The recruited patients will register to the CDSMS with their accounts given~     by their physicians. Eligible participants will be assigned to intervention and control~     groups with simple randomization. The significance level will be accepted as p<0,05. In the~     intervention group, the system recommendations on diagnosis, treatment and monitoring will~     be carried out as the final decision given by the physician. In the control group,~     physicians will treat DM patients as the general routine. Patients in both groups will be~     monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and~     laboratory outcomes will be face-to-face assessed, others will be online self-assessed.~   "
10714|NCT02917213|"~     This project aims to assess the ability of cardiac imaging (cardiac MRI and~     Doppler-echocardiography) post-processing tools to predict a combined end-point of~     intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial~     embolism in patients with first acute myocardial infarction and ventricular dysfunction.~   "
10715|NCT02917200|"~     The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and~     effective for capturing fecal residues of moxifloxacin in healthy volunteers.~   "
10716|NCT02917187|"~     The primary objective of the study is to investigate the efficacy of repeat oral dosing of~     BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The~     secondary objective of the study is to investigate the efficacy of repeat oral dosing of~     BIIB074 on varying additional aspects of pain in participants with EM; and to investigate~     the safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.~   "
10717|NCT02917174|"~     Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation,~     which is a common and frequently occurring disease in the world, and has resulted in a~     sustained increase of social and economic burden. However, several studies suggest, lots of~     asthma patients did not get their asthma controlled. The investigators study showed that in~     China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent~     years, application softwares of mobile-phones for asthma have gradually increased, studies~     suggested that application of these application softwares can make treatment more standard,~     reduce asthma attacks, help patients to control their asthma, improve adherence and these~     application softwares also show many other advantages. This study is a prospective, multi~     center, randomized, controlled study, aims to evaluate the efficacy of application softwares~     in asthma patients, provide a new tool to asthma management.~   "
10718|NCT02917161|"~     MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis~     of the prostate after this intervention. Thus, PAE might also play a role in the treatment~     of prostate cancer.~      This proof of concept study assess the impact of PAE in patients with proven prostate~     cancer.~   "
10719|NCT02917148|"~     The goal of this research proposal is to identify a miRNA expression profile as a biomarker~     to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo~     allogeneic transplantation. This biomarker, once identified, will need validation in larger~     cohorts.~   "
10720|NCT02917135|"~     This is a post-market, observational, retrospective multi-center Registry designed to gather~     information on the performance of the Angel® Catheter in general clinical practice.~   "
10797|NCT02915991|"~     This is a prospective, single-arm, unblinded, case observation study evaluating a~     commercially released 'Conformité Européenne' (CE)-mark co-registration software system~     along-side of a commercially- released CE-mark coronary physiology and X-ray system during~     routine clinical workflow. The purpose of this study is to collect Professional user~     feedback regarding clinical utility of the SyncVision 4.X system.~   "
10798|NCT02915978|"~     The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual~     Spray compared with placebo in participants with postoperative pain after a bunionectomy.~   "
10721|NCT02917122|"~     Parkinson's disease (PD) is one of the most common neurological diseases manifested by~     movement disturbance. The concomitant psychiatric symptoms, especially depression, are often~     observed and have also great impact on patients' quality of life. The treatment of~     depressive symptoms in PD with antidepressants as the majority remains variable and~     inefficient, which complicates the disease prognosis. Transcranial direct current~     stimulation (tDCS) is a non-invasive brain modulation technique and has been demonstrated to~     improve psychiatric diseases such as major depression. In this study the investigators will~     assess the combined effects of tDCS on sertraline for the treatment of depression in PD. Ten~     sessions of tDCS in two weeks will be applied and the follow-up evaluation will continue~     bi-weekly for one month after completing all sessions. The efficacy of tDCS vs sertraline~     will be compared and evaluated with behavioral and cognitive outcome. In addition, the~     investigators will evaluate if the baseline dopaminergic activity in brain could predict the~     treatment outcome by using SPECT imaging. The investigators aim to establish the therapeutic~     parameters and safety criteria of tDCS as an add-on or alternative therapy, and further~     enhance the overall clinical efficacy in the treatment of depression in PD.~   "
10722|NCT02917109|"~     The purpose of this investigation is to conduct a series of case studies on the impact of~     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning~     for participants with ADHD.~   "
10723|NCT02917096|"~     This pilot clinical trial studies the side effects and best dose of ruxolitinib phosphate~     when given together with chemotherapy before and after a donor stem cell transplant in~     treating patients with myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as fludarabine phosphate and melphalan, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving ruxolitinib phosphate together with chemotherapy before and~     after a donor stem cell transplant may help stop the growth of cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. The donated stem cells may also~     replace the patient's immune cells and help destroy any remaining cancer cells.~   "
10724|NCT02917083|"~     The subject has a type of lymph gland cancer called Lymphoma.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting~     blood cells that can kill other cells, including tumor cells or cells that are infected with~     germs. Both antibodies and T cells have been used to treat patients with cancers; they both~     have shown promise, but have not been strong enough to cure most patients. Investigators~     hope that both will work better together.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. They now want to test whether~     multiple doses of these genetically modified T cells will be more effective at killing~     cancer cells.~      The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody~     sticks to lymphoma cells because of a substance on the outside of the cells called CD30.~     Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong~     enough to cure most patients.~      For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this~     way it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells~     (CD30.CAR T cells) seem to kill some of the tumor, but they don't last very long and so~     their chances of fighting the cancer are unknown.~      Several studies suggest that the infused T cells need room to be able to multiply and grow~     to accomplish their functions, and that this may not happen if there are too many other T~     cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the~     level of circulating T cells prior to the CD30.CAR T cells infusion. This is called~     lymphodepletion.~      CD30.CAR T cells have previously been studied in lymphoma patients. What is new for this~     study is that multiple doses of CAR T cells will be administered, and that lymphodepletion~     chemotherapy will be administered in patients who are not post autologous transplant in the~     hope that it will result in more durable anti-tumor effects.~   "
10725|NCT02917070|"~     Inbreeding and consanguineous marriages are known to increase the risk of autosomal~     recessive disorders. The aim of this study was to examine the association between~     consanguinity and kidney diseases in the adult Turkish population.~   "
10726|NCT02917057|"~     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the~     treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon~     improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose~     titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other~     advantages, such as reducing insulin resistance, reducing weight, and improving blood~     pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead~     to improve outcomes in customary clinical care in patients with mild and moderate renal~     impairment and in elderly patients are unknown.~      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative~     to basal insulin initiated as first-ever injectable therapeutic regimens among elderly~     patients and patients with renal impairment. Patients who initiated treatment with Bydureon~     or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts~     from Optum's database of electronic health records. The two treatment cohorts will be~     matched by propensity score method. Changes in HbA1c, weight, markers for renal function~     (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio~     (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for~     patients with different eGFR categories and with different ages.~   "
10727|NCT02917044|"~     This is a prospective, multicentre, randomized single blind, parallel group study to be~     conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40~     eligible for randomization. The study is designed to compare the operator's best attempt at~     WACA completion with and without Rhythmia guidance~   "
10728|NCT02917031|"~     This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled~     study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and~     function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).~   "
10799|NCT02915965|"~     The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine~     (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with~     loco-regional esophageal squamous cell carcinoma (ESCC).~   "
10800|NCT02915952|"~     The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures~     when utilized for skin layer closure during wound closure of Cesarean Section Procedure.~   "
10917|NCT02914314|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of an oral suspension of~     perampanel given as an adjunctive therapy and to generate preliminary safety and efficacy~     data in pediatric participants, ranging from 1 month to less than 24 months of age, with~     epilepsy.~   "
10729|NCT02917018|"~     Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of~     general anesthesia recovery, and is characterized by agitation, confusion, disorientation,~     and possible violent behavior. The incidence of emergence agitation is less common in adults~     as compared to pediatric patients. It may lead to serious consequences for the patient such~     as bleeding, falling, removal of catheters and self extubation, which lead to further~     complications like hypoxia and aspiration.~      Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation~     has rarely been studied in adults.~      The stress response to surgery is an unconscious response to tissue injury. Activation of~     the sympathetic nervous system, increase of catabolic hormone release and pituitary gland~     suppression are considered a response to surgical stress, in clinical practice these~     activities cause changes in heart rate, blood pressure and biochemical fluctuations of~     noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong~     hospitalization and delay patients discharge.~      Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic~     and sympatholytic properties. Decreased stress response to surgery ensuring a stable~     hemodynamic state is a beneficial property of the agent. Peri-operative use of~     dexmedetomidine also decreases postoperative opioid consumption, pain intensity, and~     antiemetic therapy. However, the data related to the effects of dexmedetomidine on reducing~     agitation from general anesthesia in adults are limited.~   "
10730|NCT02917005|"~     This is an open label, randomized, multicenter, international phase II study for~     premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally~     advanced breast cancer. Patients will be randomized to receive either palbociclib +~     exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).~      Treatment will be continued until disease progression, unacceptable toxicities, or~     withdrawal of consent.~   "
10731|NCT02916992|"~     To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous~     pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate~     hospital are to be included. Patients will receive a questionnaire. When given consent, the~     investigators will invite them for a one-time visit to the out-patient clinic. Patients will~     be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a~     pulmonary CT scan for evaluation of presence of lung cysts.~   "
10732|NCT02916979|"~     This study is examining a chemotherapy regimen and immune suppressive medications in the~     setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the~     incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune~     checkpoint regulators (V-domain Ig Suppressor of T-cell Activation [VISTA], cytotoxic~     T-lymphocyte- associated protein 4 [CTLA-4], programmed death-ligand 1 [PD-L1]) during early~     immune recovery following an allogeneic stem cell transplant. The site will use a~     myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define~     clinical endpoints, including engraftment, 100 day survival and one year survival (Objective~     #1). The site will characterize the incidence, prevalence and function of MDSCs and immune~     checkpoint regulators in patients' blood and bone marrow following transplantation~     (Objective #2). The site will correlate these laboratory results with clinical outcomes and~     the incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients~     experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and~     checkpoint regulator expression and correlate these results with the patient's response to~     GVHD therapy.~   "
10733|NCT02916966|"~     The proposed research is particularly relevant to the National ALS Registry and public~     environmental health issues because it addresses the potential environmental causes of~     sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be~     compared with the national and State-Metro Surveillance Programs of the National ALS~     Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA,~     and other environmental toxicants as risk factors for ALS. This work will advance the~     mission of the CDC ATSDR National ALS Registry by offering data on ALS cases in Ohio that~     address public health concerns over the effects of chronic exposure to cyanobacterial blooms~     in Lake Erie.~   "
10734|NCT02916940|"~     There is currently no real consensus on the optimal management of acute sprains of the~     proximal interphalangeal joint of the long fingers.~      The aim of this study is to assess the beneficial effect of an injection of corticosteroids~     for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute~     phase). This treatment, if effective, might become the treatment of choice for these types~     of injuries, instead of a prolonged immobilization or a careful early mobilization.~   "
10735|NCT02916927|"~     Objective: The purpose of this study is to determine if administering ketamine as an~     intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse~     drug reactions without attenuating its analgesic effects.~      Study design: prospective, randomized, controlled, double-blind trial.~   "
10736|NCT02916914|"~     Preterms are usually fed with intervals of either two or three hours during their stay in~     neonatal intensive care unit. Recommendations of World Health Organization about feeding~     regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are~     not proposed with regards to results of randomized controlled trials. Investigators aimed to~     investigate the impact of 2-hourly feeding on time of transition from orogastric to oral~     feeding.~   "
10737|NCT02916901|"~     The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood~     pressure after oral administration in healthy adult volunteers.~   "
10738|NCT02916888|"~     The purpose of this study is to investigate the differences in the quality of life of~     patients and caregivers who are treated by general pediatricians versus pediatric~     dermatologists for eczema (atopic dermatitis or AD).~   "
10812|NCT02915796|"~     The main aim of the present study was to evaluate the therapeutic potential and safety of~     transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of~     differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty~     (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic~     patients.~   "
10975|NCT02913521|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study~     to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech~     Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in~     Patients With Osteoarthritis of the Knee~   "
10739|NCT02916875|"~     In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU)~     program for patients with ovarian cancer. The new FU program argues that there is no effect~     of routine monitoring, and every patient's FU is now individualized. These changes have~     caused major concern, especially regarding the omission of routine examinations aimed at~     detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools~     and FU plans to support the patients in feeling safe during FU are of vital importance.~      Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs,~     symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side~     effects.~      300 patients with ovarian cancer are planned to be enrolled after primary treatment when~     they enter follow-up program. This is a multi-center study.~      All participants fill in a questionnaire at baseline and then every 3 months for two years,~     and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28,~     and questions on symptoms of relapse. At baseline the questionnaire is extended with~     demographic issues.~      The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient~     satisfaction and the level of shared decision making experienced.~      All participants are followed for 3 years.~   "
10740|NCT02916862|"~     The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF)~     supplementation for 1 year on bone metabolism in growing adolescents compared to controls.~     For the proposed study, a randomized double-blinded placebo controlled clinical trial will~     be conducted in 168 healthy adolescents aged 11-14 years, equally randomly assigned to one~     of three intervention groups: SCF (12 g/d, administered twice a day), SCF + calcium (12 g/d~     of SCF + 600 mg/d of elemental calcium carbonate, twice a day), or placebo (0 g/d of SCF or~     calcium, administered twice a day). Bone metabolism and bone related biomarkers will be~     assessed at baseline and at 12 months.~   "
10741|NCT02916849|"~     This five arm feasibility study aims to promote self-management in strength and balance~     exercises among community-living older people. The research process, implementation~     strategies and procedures, acceptability of the exercise programs, perceived benefits of the~     programs, and the ecological validity, acceptability and ability to detect change of~     possible outcome measurements will be evaluated before a future randomized controlled trial.~     A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology~     based exercise program with motivational strategies, developed by researchers in~     collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises~     presented in a booklet. The older participants will be free to select either of the~     intervention programs and the selection process and outcome will be studied as part of the~     process evaluation.~      The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be~     recruited through advertisements in local papers and through posters and meetings at senior~     citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants~     will be recruited from health care centres and their registered professionals with~     experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at~     least 10 participants in each, will be exercising for four months and will undergo testing~     at baseline, after two and four months and they will be asked to keep an exercise diary~     (digital or paper format) during the intervention.~   "
10742|NCT02916836|"~     The drug iatrogenesis represents an important public health problem. In the Iatromed~     project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This~     multicenter observational study is focus on 750 patients aged over 75 year old with~     polymedication. The main objective will be to determine if the use of the TDC, at the~     discharge of hospital, allows to reduce the number of use in emergency care within the two~     month after their hospital discharge~   "
10743|NCT02916810|"~     Major psychotic symptoms such as auditory hallucination (AH) are main features of~     schizophrenia and other psychotic disorders, resulting in severe social and clinical~     dysfunction. However, these symptoms are sufficiently unresponsive to antipsychotic~     medications in a substantial portion of patients. Neuroimaging studies suggest that aberrant~     activities at specific brain regions such as frontal areas, sensory areas and~     language-related areas are related to these symptoms. Transcranial magnetic stimulation~     (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has~     been used in a wide range of clinical research especially in neurology and psychiatry. There~     are preliminary treatments of psychosis and AH using TMS but results are inconsistent. The~     high inter-subject variability limits the efficacy of TMS treatment for schizophrenia~     patients. The investigators aim to develop a TMS treatment method with a functional~     MRI-defined treatment target area, where the TMS target is individually identified to~     maximize the TMS effects. If the current target-identification successfully identified~     effective TMS target individually, the treatment efficacy could be significant improved and~     more patients will benefit from TMS treatment.~   "
10744|NCT02916797|"~     -  Are there differences in immediate effects of stepping training with and without the~          use of visually weight-taking machine (VWTM) on variables relating to well-controlled~          walking and walking symmetry in ambulatory patients with stroke?~        -  Are there differences of 4-week stepping training with and without the use of VWTM on~          variables relating to well-controlled walking and walking symmetry in ambulatory~          patients with stroke?~   "
10745|NCT02916784|"~     1. Were there differences in functional ability between ambulatory individuals with SCI~          who passed and failed the independent sit-to-stand (iSTS) task?~        2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD~          used?~        3. What were factors associated with the ability of iSTS?~   "
10746|NCT02916771|"~     This research study is evaluating a new drug called ixazomib as a possible treatment for~     Smoldering Multiple Myeloma.~   "
10747|NCT02916758|"~     This study evaluates the program outcomes of the Let's Go program. The standardized~     community mobility program employs multi-modal group and individual sessions to facilitate~     wellness in older adults.~   "
10748|NCT02916745|"~     This research study is being conducted to assess the safety and feasibility of using a new~     developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects~     with peripheral stage T1A non-small cell lung cancer (NSCLC), who are inoperable or refused~     surgery, and are not candidates or refused radiation therapy. It will involve 10 sites in~     USA and Canada. Participation will last 6 months.~   "
10750|NCT02916719|"~     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the~     loco-regional staging and direct the treatment.~      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement~     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care~     consists of realizing a MRI before the start of the NAC and another one after it's ended,~     six months later.~      There is currently no consensus on the realization of an interval MRI for early assessment~     of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic~     regimen in the event of a non response. Similarly, there is no consensus on when this~     interval MRI should be performed.~      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is~     interesting for the evaluation of the early response. However, these are preliminary studies~     with quantitative measures realized by the region of interest (ROI) method. A response to~     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients~     (ADC).~      There is'nt any published data on the potential interest of breast MRI after a radiotherapy~     treatment and before the surgical treatment.~      Therefore, the expected benefits of this study are:~        -  to monitor the early modifications of the perfusion and diffusion parameters at the~          level of the tumor after radiotherapy, and correlate them to the histology of the~          surgical monster.~        -  to assess if MRI is able to objectivate the early signs of response after a~          radiotherapy neo-adjuvant treatment of breast cancer.~      This record is linked to the NCT02858934 record and will share the same cohort of patients~   "
10751|NCT02916706|"~     This study is designed as a prospective, multi-centre, parallel group, double-blind~     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety~     of MP-513 (Teneligliptin).~   "
10752|NCT02916693|"~     The only class of oral erectile dysfunction (ED) medication on the market are the~     phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the~     effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder~     (OAB) symptoms and mild to moderate ED.~   "
10753|NCT02916680|"~     The overall objective is to establish that transplantation of allogeneic pancreatic islet~     cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and~     does not cause ophthalmic or systemic complications. Furthermore, the change in insulin~     production, glucose control and hypoglycaemia awareness will be assessed.~   "
10754|NCT02916550|"~     This study examines the impact of a breathing training intervention on cardiorespiratory~     sensations and anxiety in adults with cardiac arrhythmias.~   "
10755|NCT02916537|"~     The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET)~     imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane~     Antigen (PSMA) and is designed to detect prostate tumors.~   "
10756|NCT02916524|"~     The purpose of this investigation is to implement a computational model that can predict and~     optimize training and cross-language generalization patterns for bilingual persons with~     aphasia (BPA). The proposed work will determine the best possible treatment program for each~     individual patient even before they are rehabilitated. In addition, the computational model~     allows specification of variables such as age of acquisition, language exposure/proficiency,~     impairment and their systematic influence on a range of language rehabilitation outcomes.~   "
10757|NCT02916511|"~     The purpose of this study is to evaluate safety and 2-year local control rate for extensive~     clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for~     esophageal squamous cell carcinoma.~   "
10758|NCT02916498|"~     The study aims to better understand how to program Spinal Cord Stimulation for the treatment~     of chronic low back and leg pain~   "
10759|NCT02916485|"~     Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting~     Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo~     coronary artery lesions.~   "
10760|NCT02916472|"~     Only a few clinical trials evaluating the potential benefits of exercise have been conducted~     in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the~     potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer~     survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility~     (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise~     program on fitness, body composition, quality of life, sleep and cognition.~   "
10761|NCT02916459|"~     This is a prospective randomised diagnostic clinical study to determine whether the use of a~     new flexible sampling needle can improve the yield of endobronchial ultrasound guided~     transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical~     reasons as deemed necessary by the managing physician or multidisciplinary team will be~     randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be~     performed under local anaesthesia using conscious sedation or general anaesthesia according~     to usual practice at the trial centre. Specimens will be placed in saline and formalin and~     forwarded to the pathology laboratory. The specimens will be spun down to create a cell~     pellet which will undergo cytological and histological examination as per usual protocol at~     the trial centre.The pathologist, who will be blinded as to which technique was used to~     obtain the sample, will grade the quality, quantity, and cellularity of the specimens.~   "
10762|NCT02916446|"~     This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy~     in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg~     or a placebo for a period of 6 months, after which all subjects will be receiving the active~     treatment up to a period of 3 years under active treatment.~   "
10813|NCT02915783|"~     This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with~     everolimus in participants with unresectable advanced or metastatic non clear cell renal~     cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. The~     primary objective of the study is to evaluate the objective response rate (ORR). This study~     consists of three phases: a Pretreatment Phase (Screening and Baseline Periods), a Treatment~     Phase (starting Cycle 1, Day 1), and a Posttreatment Phase (End of Treatment Visit and~     survival Follow-up).~   "
10814|NCT02915770|"~     This study evaluates the clinical application of cholangiojejunostomy in the surgical~     treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of~     participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the~     other half will receive hepatectomy and T-tube Drainage.~   "
10763|NCT02916433|"~     This study is an open-label, randomized controlled trial. Patients will be randomized into~     two groups of 15, Routine Care group, which will serve as the control group, and~     Octreotide group. The amount of bronchial secretions is routinely measured in all~     mechanically ventilated patients. Once the Primary Team identifies a patient as a candidate~     for the study (based on the inclusion and exclusion criteria) and an informed consent has~     been obtained, the baseline volume of bronchial secretions per 12-hour period will be~     recorded and a security envelope containing group assignment will be opened by the ICU~     attending. Both groups will continue to receive treatments that have already been initiated~     to manage bronchial secretions. In addition, Octreotide group will receive parenteral~     octreotide, while Routine Care group will receive care as deemed necessary by the Primary~     Team. The rate of bronchial secretions will be measured and recorded daily; the changes,~     relative to the baseline measurements, will be compared between the groups. These~     interventions will be continued for 72 hours or until extubation or withdrawal from the~     study, whichever occurs earlier. Subsequently, the standard of care management, as~     determined by the Primary Team, will be resumed.~   "
10764|NCT02916420|"~     This study aims to assess the efficacy and safety of pomalidomide in combination with~     low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.~   "
10765|NCT02916407|"~     The investigators evaluate extubation time and recovery profiles in children undergoing~     entropion surgery.~   "
10766|NCT02916394|"~     The investigators developed [68Ga]-labelling Anti-IGF-1R Affibody Molecule as a targeted~     molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.~   "
10767|NCT02916381|"~     Unilateral mastectomy is associated with moderate to severe postoperative pain. A new~     regional anaesthetic technique has been recently described, call the PEC block. This~     technique consists of injecting local anaesthetic between different muscles of the chest in~     order to relieve postoperative pain. The investigators aim to verify that this technique has~     a clinical relevant postoperative analgesic effect. For that purpose, the investigators will~     randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group~     will receive a PEC block after the induction of the general anaesthesia under ultrasound~     guidance, while the other group will not have this regional procedure.~   "
10768|NCT02916368|"~     Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck~     malignant tumors .Investigators found that several patients with early TNM stage and poor~     differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well~     differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis~     factors and survival rates probably related to the differentiation of HNSCC, and prognosis~     factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the~     prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.~   "
10769|NCT02916355|"~     Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single~     dose, placebo-controlled, double blind, cross-over, proof-of-concept study.~      16 healthy young men will be included in this study. The objective of this study is to~     evaluate if severity of postprandial fatigue is driven by IL-1.~      Since fatigue is associated with increased cytokine levels, and since fatigue in chronic~     inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β,~     postprandial fatigue might also respond to anti-inflammatory intervention with IL-1~     inhibition.~      The aim of the study is to investigate whether postprandial fatigue is, at least in part,~     driven by the IL-1 system.~   "
10770|NCT02916342|"~     The interscalene block provides effective analgesia after shoulder surgery. It consists of~     injecting local anaesthetic within the brachial plexus, in the interscalene groove, between~     the anterior and middle scalene muscles. Unfortunately, this technique is associated with~     respiratory complications such as hemidiaphragmatic paresis due to the spread of the local~     anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an~     incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in~     patients suffering from a reduced respiratory function such as chronic obstructive pulmonary~     disease; this entity may even represent a contraindication to the performance of the block.~      The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them~     coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have~     successfully identified and block these two nerves under ultrasound guidance. Only one~     randomised controlled trial compared interscalene block with a combination of suprascapular~     and axillary nerve blocks, and showed inconclusive results probably due to the absence of~     ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while~     patients with an interscalene block had reduced pain scores in the recovery room. Besides,~     the authors did not investigate the impact on the respiratory function.~      In that randomised controlled trial, the investigators would like to compare the analgesic~     efficacy and the respiratory outcomes between the interscalene block and the combined~     suprascapular-axillary nerve blocks.~   "
10771|NCT02916329|"~     The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted~     molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.~   "
10772|NCT02916316|"~     All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme~     R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline~     (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients~     (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of~     R-CHOP.~   "
10808|NCT02915848|"~     Movement disorders such as Parkinson Disease, dystonia, and tremor are related to~     abnormalities of part of the brain known as the basal ganglia. Recently, it has been~     suggested that the basal ganglia works by oscillations (group of neurons cycle between~     activation/deactivation when stimulated) of electrical signals. A treatment that involves~     insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known~     as deep brain stimulation (DBS), is an established treatment for advanced Parkinson's~     disease. However its mechanism of action is still not completely understood. Currently, DBS~     utilizes an open loop system whereby the stimulation settings are manually adjusted~     depending on the patients' clinical response.~        1. Determine whether the local field potential (LFP) recorded from the STN is stable over~          a 1.5 year period.~        2. Address whether STN LFP is a suitable control signal, and how it should be used to~          change DBS parameters~   "
10773|NCT02916303|"~     Schizophrenia has very significant economic consequences. Costs fall on many different parts~     of society, especially on individuals with schizophrenia and their families. The first five~     years after onset appears to be a critical period in which the symptoms are more responsive~     to treatment. In addition, if left untreated for a long time, psychosis can impact many~     areas of a person's life. The evidence base regarding the effectiveness of specialist early~     intervention services for psychosis has grown steadily and evidence from randomized~     controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority~     of specialized early intervention programs over standard care on a broad range of outcomes~     including symptomatic and vocational, social functioning, and reduced inpatient care and~     treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the~     cost-effectiveness of early intervention programs for first-episode psychosis is limited.~     The provision of such services requires investment by health departments and services, and~     the question of whether such services represent value for money has to date received little~     research attention. Only a few international studies, and none conducted in Spain, have~     investigated the cost effectiveness of early intervention in psychotic disorders at medium~     (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse~     the cost-effectiveness of an intensive early-intervention programme, using data from First~     Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode~     non-affective psychosis in Spain to date.~   "
10774|NCT02916290|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA (13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation.~      However, about 40% of patients do not respond to UDCA optimally as assessed by known~     criteria for biochemical response. Those patients represent the group in need for additional~     therapies, having increased risk of disease progression and decreased survival free of liver~     transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver~     fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine~     for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that~     Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind~     of etiology. Here the investigators start a random, open and parallel clinical research to~     explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.~   "
10775|NCT02916277|"~     In this study; in patients undergoing mechanical ventilation, making the day series Endocan~     measurements during the first 5 day to look at whether there is a relationship between the~     levels of VAP with Endocan. This relationship, if any, aimed to investigate whether~     correlated with clinical and laboratory findings [presence of fever, pathological lung~     X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)]~     .~   "
10776|NCT02916264|"~     It is a randomized control trial to compare the surgical plethysmographic index (SPI)~     response during a Mayfield head-holder insertion in neurosurgical patients who receive a~     scalp block versus those who do not receive the scalp block after induction of anesthesia~     with propofol with fentanyl and intubation with cis-atracurium.~   "
10777|NCT02916251|"~     The trial is a single-centre, randomised, sequential, cross-over trial assessing~     pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon*)~     administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and~     hypoglycaemic conditions and compared to marketed glucagon.~      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207~   "
10778|NCT02916238|"~     Depression is often the most prevalent mental health problem among people living with HIV~     (PLWH) worldwide, and if not adequately treated, it may impair response to antiretroviral~     treatment (ART) and the ability of individuals to adhere to medications and healthy~     behavior. Most patients with depression receiving ART in the poorest countries of the world~     are left untreated because no systematic approach or expertise is available. This study~     adapts an evidence-based model of depression care (Measurement-Based Care - MBC) using~     auxiliary HIV clinic staff, and tests feasibility and assesses costs among HIV positive~     patients beginning ART in Port-au-Prince, Haiti.~   "
10779|NCT02916225|"~     The purpose of this study is to determine whether high intensity interval training (HIIT) is~     superior to moderate continuous training in increasing cardiopulmonary capacity in heart~     failure with preserved ejection fraction patients.~   "
10780|NCT02916212|"~     This project aims to reduce the frequency of duplicate, false and clinically insignificant~     alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm~     frequency. The investigators will implement evidence-based guidelines for alarm optimization~     according to patient-population specific parameters, and evaluate alarm frequency and staff~     perception of alarm fatigue at baseline and 60 days after implementation of this quality~     improvement initiative.~   "
10781|NCT02916199|"~     The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as~     an initial procedure for biliary access in patients with common bile duct stones who are at~     increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography~     (PEP) and to assess the incidence rate of complications including PEP between NKF and~     conventional cannulation methods.~   "
10782|NCT02916186|"~     The goal of the present study is to compare the amount of root coverage resulting from~     subepithelial connective tissue graft and acellular dermal matrix associated with tunnel~     technique among patients suffering from multiple gingival recession.~   "
10783|NCT02916173|"~     The follicular phase of the menstrual cycle involves the hourly release of~     gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results~     in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses~     that regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant~     follicle and a small rise in progesterone lead to a gonadotrophic surge. An increase in the~     amplitude of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte~     maturity and triggers ovulation approximately~   "
10809|NCT02915835|"~     The primary objective of this study is to provide preliminary data on the efficacy (digital~     ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to~     placebo in patients with scleroderma-associated digital ulcers~   "
10976|NCT02913508|"~     The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of~     multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).~   "
10784|NCT02916160|"~     Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant~     morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of~     cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity~     and mortality. To date, the CHF medical treatments have been reported to be inconsistently~     efficient in the treatment of SAS.~      SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level~     B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF~     trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN.~     In comparison to enalapril, it reduced the occurrence of cardiovascular death or~     hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.~      The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF~     patients presenting sleep apnea syndrome. A three months real life observational trial is~     performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of~     SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of~     life parameters is realized.~   "
10785|NCT02916147|"~     This study aim to observe and compare the change of alarmins such as high mobility group~     nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin~     (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and~     soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile~     anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study~     will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect~     of inhalational and intravenous anesthesia on the prognosis of surgical patients.~   "
10786|NCT02916134|"~     This study aims to compare antibiotic treatment versus surgery for patients with~     uncomplicated appendicitis.~   "
10787|NCT02916121|"~     The investigators study aims are:~        1. To investigate folate, vitamin B12, and homocysteine levels in patients with~          schizophrenia.~        2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels,~          genetic variants of one-carbon cycle pathway, psychopathology, including positive~          symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients~          with schizophrenia.~        3. For patients with low folate levels, the investigators would like to conduct a 24-week~          double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d)~          supplementation study to know whether combination of folic acid and vitamin B12 can~          improve patients' psychopathology or metabolic profiles, and the effects of genetic~          variants in one-carbon cycle pathway on treatment response.~   "
10788|NCT02916108|"~     Approximately 150,000 children present each year to emergency departments (EDs) in the US~     with concussion and many more are treated by primary care physician, or outpatient~     specialists.~      Concussion is defined as a traumatically induced transient disturbance of brain function and~     involves a complex pathophysiological process. There is a variety of symptoms related to~     concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since~     there is a various degree of the severity of those symptoms, the diagnosis is a subjective~     one and lacks sensitivity.~      One major problem is that approximately one-third of the children with concussion experience~     ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as~     persistent post-concussion symptoms. A recent study that investigated the validity a~     12-point PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the~     greatest concerns is the child's schedule return to activity.~      Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it~     is likely to be expressed in desynchronization of delta wave activity between anterior~     hemispheres as seen in pathological problems related to attention and/ or working memory).~      The aim of this proof-of-concept study is to find-out whether interhemispheric~     desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute~     concussion in children. If the investigators find that IHDD can accurately diagnose acute~     concussion, a second objective will be to examine whether this index can be a useful tool in~     the follow up of patients with persistent post-concussion symptoms.~   "
10789|NCT02916095|"~     The purpose of this study is to evaluate the safety , tolerability, pharmacokinetics of~     Kanitinib and determine the optimal dose in patients with recurrent or metastatic solid~     tumors.~   "
10790|NCT02916082|"~     To evaluate the value of measuring cervical length as a predictor of vaginal birth after~     induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.~   "
10791|NCT02916069|"~     Multimodal brain monitoring is feasible and can be used in formulating therapeutic~     strategies during cardiac surgery. Such monitoring may help to improve patient outcome and~     to reduce costs after cardiac surgery with CPB.~   "
10792|NCT02916056|"~     This is an open-label extension study in patients with mild Alzheimer's disease who have~     completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive~     azeliragon 5 mg/day for up to 2 years.~   "
10793|NCT02916043|"~     Cell-count related risk factors for acute kidney injury after cardiovascular surgery have~     been reported. The authors attempted to investigate whether the perioperative cell counts of~     neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury~     and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.~   "
10794|NCT02916030|"~     Stroke remains one of the most devastating neurological diseases, often causing death, or~     gross physical impairment. It is the second most common cause of death worldwide and a major~     cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute~     to the risk of cardiovascular disease especially stroke.~   "
10795|NCT02916017|"~     This study evaluates the long- term safety and effectiveness of adalimumab in participants~     with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.~   "
10796|NCT02916004|"~     The aim of the study was to describe the feasibility of the nociception flexion reflex and~     the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care~     Unit (ICU). Furthermore to describe the relationship between the responses and the standard~     of care pain evaluation in the critically ill sedated patients.~      Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol~     during measurements in a stair-case increasing intensity model of standardized stimulations.~     (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents~     monitoring.)~   "
10801|NCT02915939|"~     Emerging research on family caregiving and institutionalization has emphasized that families~     do not disengage from care responsibilities following a relative's admission to residential~     long-term care settings. The Residential Care Transition Module (RCTM) provides 6 formal~     sessions of consultation (one-to-one and family sessions) over a 4-month period to those~     family caregivers who have admitted a cognitively impaired relative to a residential~     long-term care setting (nursing home, assisted living memory care unit) in the prior 3~     months. The proposed mixed method, randomized controlled trial will determine whether and~     how the RCTM decreases family caregivers' emotional and psychological distress,~     placement-related strain, and increases relative's transitions back to the community. The~     RCTM will fill an important clinical and research gap by evaluating a psychosocial~     intervention designed for families following RLTC placement to determine whether and how~     this approach can help families better navigate the residential care transitions of~     relatives with Alzheimer's disease or a related dementia.~   "
10802|NCT02915926|"~     A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on~     self-efficacy and occupational performance with mothers of children with cerebral palsy.~     Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be~     employed to data collection. The sample size was determined for each group of 15 people. The~     participants conveniently and according to inclusion and exclusion criteria will be~     randomized into the groups. Participants in the intervention group will be participated in~     10 sessions of OPC. At the end the questionnaires will be completed by both groups.~   "
10803|NCT02915913|"~     The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance~     or Combined program has benefits on Cognitive Function as well as on secretion and~     regulation of neurotrophic factors or neurotrophins in a cohort of sedentary, overweight~     adults (aged 18-30 years) from Bogota, Colombia.~   "
10804|NCT02915900|"~     During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with~     gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of~     gonadotropin is important to avoid maturation of too few or too many follicles, which may~     impair the chances of treatment success, lead to treatment cancellation, or serious side~     effects.~      Motivated by the lack of standardised procedures to estimate the optimal dosage of~     gonadotropins, a patient-specific test has been developed to predict the optimal hormone~     dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated~     form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a~     patient needs increased or reduced hormon doses.~      In this clinical study the investigators compare deviation from optimal outcome at oocyte~     pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes~     collected in the group of patients matching the inclusion criteria of the study.~      The control group receives starting hormone dosage assigned by the clinician according to~     standard clinical procedures. The intervention group receives starting hormone dosage~     adjusted according to the results of the Gonadotropin Removal Test.~   "
10805|NCT02915887|"~     Objective: This study examined the effects of elastic tape applied to the neck on patients~     experiencing chronic neck pain.~      Background: Neck pain is often persistent or recurrent. Various treatments have been~     described, including exercises and manual therapy. Taping is commonly used clinically in the~     management of neck pain, however research in this field is sparse.~      Methods: Elastic tape was applied over the posterior cervical extensor muscles from~     insertion to origin on patients experiencing chronic neck pain. Patients were assessed~     pre-taping, immediately post-taping, and one week post-taping and did not receive additional~     physiotherapy during the study.~      Subjective measures included the Visual Analogue Scale (VAS) for pain intensity, the Neck~     Disability Index (NDI) to determine the level of disability in daily living, and the Tampa~     Scale of Kinesiophobia (TSK) to assess fear of movement or re-injury. Objective outcome~     measures included cervical range of motion, velocity, smoothness, and accuracy of cervical~     motion. These kinematic measures were collected using a customised virtual reality system~     designed to evaluate neck motion disorders.~   "
10806|NCT02915874|"~     The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day~     psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12~     week time control group on anxiety symptoms, vascular function, inflammation, muscle~     sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at~     baseline in individuals with low or no anxiety for comparison. Individuals who are~     interested in the study will be identified by an online screening survey and will be~     contacted by the research team; advertisements, flyers and mass emails will direct~     individuals to the online screening survey. Those deemed eligible to participate will be~     randomized to the ACT intervention or a control group. Assessments of anxiety symptoms (via~     various surveys) and vascular function (via non-invasive, well-established techniques) will~     be performed at baseline and 12 weeks post-ACT group intervention session. In addition,~     reassessment of anxiety symptoms via aforementioned surveys will take place 6 weeks post-ACT~     group session. After 12 weeks, anxiety and vascular assessments will be repeated to~     re-evaluate severity of anxiety symptoms, vascular function, inflammation, and oxidant~     stress.~   "
10807|NCT02915861|"~     This is an observational study of patients with scrub typhus (rapid diagnostic~     test/quantitative polymerase chain reaction (RDT/qPCR) positive) and an inoculation eschar~     present on examination, recruited from Chiangrai Prachanukroh Hospital, North of Thailand.~      In this study, we aim to:~        -  Investigate relevant pathogen dissemination dynamics, early innate immune response, and~          pathogen-host interactions in scrub typhus using a minimal set of easily accessible~          samples; the inoculation eschar (crust or biopsy), whole blood and - where possible - a~          lymph node fine-needle aspiration (FNA).~        -  Determine the potential use of the inoculation eschar for improving early diagnostics~          and assessing the diversity of human pathogenic strains; by evaluating non-invasive~          swabs and scrapings, as well as biopsies for molecular diagnostics templates.~        -  Dissect the underlying patho-biology associated with the inoculation eschar and in a~          subgroup, including the draining lymph node; by defining the spectrum of infected cells~          via microscopy and double-immune labeling; by determining cytokine and RNA gene~          expression profiles in blood peripheral blood mononuclear cell (PBMCs) and eschar~          samples.~   "
35505|NCT02592239|"~     The purpose of this study is to determine the relationship between brain activity and the~     perception of subjective hedonic sensations in response to a meal using functional MRI.~   "
10815|NCT02915757|"~     Suicide, suicide attempts and depression are major social problems. The present research~     program focuses on the relationship between electrodermal hyporeactivity, as measured by the~     ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death~     intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has~     in several publications from different laboratories repeatedly been shown to have a high~     sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are~     unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be~     considered as strongly significant. Almost all evidence in the topic up today has been~     established in research settings with specific exclusion criteria for some secondary~     psychiatric and some somatic illnesses. However, it is important to study the relationship~     between electrodermal hyporeactivity and suicide in relatively unselected patients regarding~     secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation~     and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity~     fits very well into the daily clinical work.~   "
10816|NCT02915744|"~     This is an open-label, randomized, active comparator, multicenter, international Phase 3~     study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain~     metastases and have been previously treated with an anthracycline, a taxane, and~     capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be~     omitted if medically appropriate or contraindicated for the patient).~   "
10817|NCT02915731|"~     This study will assess total body vitamin A pool size, as well as liver vitamin A stores, by~     means of stable isotope dilution in preschool children from a South African community where~     liver, an exceptionally rich source of vitamin A, is frequently eaten, and the children~     exposed to vitamin A fortified staple foods, as well as a vitamin A supplementation~     programme.~   "
10818|NCT02915718|"~     Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third~     most common cause of heart failure and the most frequent reason for heart transplantation.~     The etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of~     literature suggesting that the humoral immune system activation and autoantibodies against~     myocardial generation play an important role in the progression of DCM. At present~     immunoadsorption technology has been successfully applied in autoimmune antibody removal~     treatment of a variety of diseases. And some applications of immunoadsorption(IA) in~     patients with DCM showed that immunoadsorption(IA) can indeed reduce the autoantibodies,~     improve symptoms and prognosis, but additional research is needed to identify indications~     and instruments for the IA treatment of DCM.~   "
10819|NCT02915705|"~     UX023-CL301 is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy~     and safety of KRN23 with active control (oral phosphate/active vitamin D therapy) in~     children with XLH (aged 1 to ≤12 years) who have radiographic evidence of rickets, open~     epiphyses, and have received oral phosphate/active vitamin D therapy for ≥ 6-12 consecutive~     months prior to screening. Approximately 60 subjects will be randomized 1:1 to receive~     open-label KRN23 administered by subcutaneous injection or oral phosphate and active vitamin~     D therapy for a total of 64 weeks.~   "
10820|NCT02915692|"~     The Foley catheter is one component in a catheter insertion procedure that could contribute~     to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter~     insertion procedure using the ERASE CAUTI Tray system may help to lower these infection~     rates.~   "
10821|NCT02915679|"~     In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain~     where mental trouble has a major influence. It is classified as preventable mortality.~     According to interpersonal psychological theory of suicide, the repeated exposition to~     stressful and painful events (as physical abuse) would facilitate suicide attempt through~     the increased pain tolerance. The social pain (or psychical pain on the broader sense) and~     physical pain are closely linked.~      The investigators hypothesize that the measure of painful perception will be significantly~     superior on suicidals attempters compared to non-attempters. It will be the case for recent~     suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait.~     Moreover, the investigators expect that social distress induced by a social exclusion~     paradigm will be significantly superior on suicide attempters compared to non-attempters.~      The aim of the study is to investigate the physical and psychic pain on depressed subjects~     with or without history of suicide attempts.~      After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal~     dimension), subjects will be submitted to a painful thermic stimulation and will participate~     at a computer test of social exclusion (named Cyberball).~   "
10822|NCT02915666|"~     This study is being done to find out if the combination of dabrafenib, trametinib and~     digoxin will lessen the side effects that you may experience and to measure your response~     and duration of response to the combination of drugs.~   "
10823|NCT02915653|"~     The study is a pre-post two round, randomized controlled study design of PCPs randomly~     assigned to a control or 1 of 2 intervention arms.~   "
10824|NCT02915640|"~     This study compares the utilization of remote technology versus not using remote technology~     when triaging and managing pediatric patients in remote settings prior to pediatric~     specialized inter-facility transportation.~   "
10825|NCT02915627|"~     Study comparing different groups of people and how they respond to application of the~     non-pneumatic anti-shock garments. Investigators will divide all recruited participants into~     three groups based on health status (group 1: hemodialysis patients; group 2: patients with~     severe chronic kidney disease but not on dialysis; group 3: healthy participants with no~     clinically known kidney disease). Each group, which will comprise of 10 people, will receive~     the same treatment using the non-pneumatic anti-shock garments.~   "
10844|NCT02915263|"~     The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment~     effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment~     induced neuropathy (TIND).~      The investigators hypothesize that immune globulin, administered intravenously (IVIG), will~     reduce the pain associated with treatment induced neuropathy and reduce the neuropathy~     severity.~      Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The~     preliminary data will be used to power a larger treatment trial, and to aid the~     understanding of the mitigating factors in the treatment response.~   "
10826|NCT02915614|"~     In a former study, the investigator observed significant differences in the response to~     pulmonary rehabilitation between COPD patients with the normal genetic variant of alpha-1~     antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al.,~     2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise~     capacity compared to PiMM patients. This latter finding was mirrored by an increase of~     oxidative myofiber type I proportion - that is important for aerobic exercises in daily life~     - in PiMM but not PiZZ patients.~      Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to~     compare the effects of pulmonary rehabilitation including exercise training on a) specific~     enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b)~     the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD~     patients.~   "
10827|NCT02915601|"~     Low serum bicarbonate levels, even within the normal laboratory range, are strongly~     associated with increased risks of hypertension, endothelial dysfunction, cardiovascular~     disease and death. The current proposal will investigate whether bicarbonate administration~     in patients with chronic kidney disease (CKD) will improve the health and function of~     arteries and reduce the size of the left ventricle of the heart. Overall, the proposed~     research will provide important new scientific evidence upon which physicians can base~     recommendations to patients with CKD to decrease the risk of developing cardiovascular~     diseases.~   "
10828|NCT02915588|"~     The purpose of the study is to compare two different rehabilitation protocols after~     arthroscopic rotator cuff surgery.~   "
10829|NCT02915575|"~     The purpose of this trial is to test the clinical benefit and feasibility of structured risk~     based post discharge care for hospital acquired Acute kidney injury survivors.This is a~     Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166~     participants will be enrolled in this Randomized controlled trial..~   "
10830|NCT02915562|"~     The purpose of this study is to determine the effects of depressive mood on outcomes of an~     in-house rehabilitation program.~   "
10831|NCT02915549|"~     To test the hypothesis that progressive feeding without minimal enteral feeding (MEF)~     compared to progressive feeding preceded by a 4-day course of MEF will result in an~     increased number of days alive on full enteral feeding in the first 28 days after birth in~     extremely preterm infants receiving human milk.~   "
10832|NCT02915536|"~     With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully~     combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated~     iodine geographical environment with wide natural variation in the iodine content of~     drinking water. It has been reported that the water iodine of at least 11 provinces and~     cities in China is high, with nearly 31 million people exposed to the risks of excessive~     iodine intake. This has raised a new public health concern that a safe upper level of iodine~     intake should be established to ensure that people avoid ingesting excessive iodine intake~     while continuing to implement USI to control IDD. The investigators have successfully~     explored the tolerable upper intake level (UL) of iodine for Chinese adults by conducting a~     randomized double-blinded trial in 256 euthyroid volunteers. However, due to limited data on~     the safe upper intake level of iodine for children worldwide, current ULs of iodine for~     children are extrapolated from those for adults based on body weight or body surface area.~     As it is impossible to ethically conduct a randomized clinical trial regarding excessive~     iodine intake in children, the investigators plan an observational study to investigate~     children who have been living with different drinking water iodine levels for over 5 years,~     observing the changes of thyroid function in response to each iodine exposure level. Subtle~     changes in thyroid function and thyroid volume of children corresponding to different iodine~     intake levels will be determined, which will contribute to the establishment of UL of iodine~     for children.~      The aim was:~        1. To establish the tolerable upper intake level (UL) of iodine for children of China.~        2. To define the adverse effects of excess iodine on children.~        3. To monitor the iodine status of children living in high water iodine areas in China.~   "
10833|NCT02915406|"~     This protocol is designed to enable access to related or unrelated CD34 cells manufactured~     using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell~     depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include~     patients with inherited immunodeficiency disorders as well as patients with malignancies,~     bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor~     graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost~     of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are~     CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY~   "
10834|NCT02915393|"~     Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of~     the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS~     would be researched in this project deeply and systematically with modern life-scientific~     methods. Based on the previous work, the participants, with SDS, suffering from Qi~     deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric~     cancer would be included, and the corresponding research would be conducted at the~     molecular-cell-gastric tissue level, and at the same time, systematical biological database~     of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing~     technology created in our research group, proteomics and metabonomics. Under the above work,~     the investigators would conduct data mining and molecular network analysis, and then verify~     the key functions. By analyzing the systematical biological features of syndrome and its~     relationships with constitution and disease, this study would provide a new basis for~     objective reality of syndrome, and also offer a crucial premise of revealing biological~     basis for syndrome correctly, which is of important theoretical and practical significance.~   "
10835|NCT02915380|"~     Recently, the occurrence and potential impact of pituitary dysfunction after aSAH has gained~     increasing interest. Several studies have demonstrated pituitary dysfunction after SAH~     suggesting that pituitary dysfunction may be a contributing factor for residual symptoms~     after SAH. This is an observational multicentric study aimed to test the prevalence of~     thyroid abnormalities, other neuroendocrinological dysfunction and their influence on~     outcome of patients affected by aSAH.~   "
10836|NCT02915367|"~     Next generation real-time monitoring for PrEP adherence in young Kenyan women~   "
10845|NCT02915250|"~     This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period~     cross-over study using a standardised solid meal test in subjects with type 2 diabetes to~     investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25~     and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate~     dosing visits.~   "
10977|NCT02913495|"~     The purpose of this study is to evaluate the two suggested therapies for prevention of~     recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and~     intramuscular progesterone to determine whether vaginal progesterone is superior to~     intramuscular progesterone in the prevention of recurrent preterm birth.~   "
10837|NCT02915354|"~     The inclusion criteria was patients who aged 18 or older with ankylosing spondylitis,~     fulfilled the 1984 modified New York criteria for AS. Inclusion criteria enriched the AS~     patients with clinical remission, including the following definition: 1. Administration of~     etanercept 50 mg for 6-week period at least; 2. Acquisition of Assessment of~     SpondyloArthritis International Society criteria 20(ASAS20) response at the end of the~     treatment. We excluded patients who have developed to complete spinal fusion. We also~     excluded patients with kidney disease induced by other conditions; pregnancy; suckle;~     accompany other chronic diseases; various infections in acute stage; and other infectious~     diseases. At the end of the trial, patients who fulfilled the inclusions would stop~     etanercept treatment. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal~     anti-inflammatory drugs could be continued if maintained at a stable dose;Patients were~     followed up from the time of etanercept withdrawal per 6 weeks for 3 years by telephone. If~     symptoms suggestive of relapse or other problems occurred, patients were invited to come~     back to the center. Relapse after etanercept withdrawal was defined as an increase Bath~     Spondylitis Disease Activity Index(BASDAI)15 score goes back to 80 percentages of it at the~     beginning of the trial16. The following data were collected: demographic and disease~     characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing~     Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score~     (ASDAS)1718) and biologic values at baseline of the trial and the time of relapse. Adverse~     events and other safety measures were also collected.~   "
10838|NCT02915341|"~     The overall objective of this study is to extend previous work in the development of methods~     to automatically detect the timing of cocaine use from cardiac interbeat interval and~     physical activity data derived from wearable, unobtrusive mobile sensor technologies. The~     specific objectives of this protocol are to characterize under which conditions high quality~     continuous interbeat interval data and physical activity data can be obtained from a~     specially developed smartwatch device in the natural field setting among a population of~     cocaine users. In addition to identifying common failure scenarios and understanding~     wearability/usage patterns when collecting interbeat interval from smartwatches, this study~     will extend previous work in the detection of cocaine use via interbeat interval and~     physical activity data that were previously obtained from wearable chestband sensors.~     Information from this study will contribute toward the adaptation of the investigators'~     existing computational model for detecting cocaine use via the chest sensors, so it can be~     applied to the interbeat and physical activity data obtained from less obtrusive~     smartwatches.~   "
10839|NCT02915328|"~     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The~     intra and/or postprocedural cerebral embolization remains the most frequent complication.~      The type of carotid stent and of cerebral protection are the two most important variables~     potentially affecting the rate of cerebral microembolization. So far there no consensus on~     the the best stent and cerebral protection.~   "
10840|NCT02915315|"~     Essential hypertension is a complex trait which results from interaction between~     environmental factors and genetic factors. Our study aimed to detect the differential~     expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt~     sensitive hypertension in human based on a chronic salt loading study conducted in Lantian~     county, China. Firstly, a chronic salt loading study will be conducted in a Chinese~     population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs~     and DNA methylation Chip analysis will be performed using samples collected from~     salt-sensitive and salt resistant individual, and the results will be analyzed by modern~     bioinformatics methods to seek for differential genetic markers. In addition, the~     investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP,~     microalbuminuria and baPWV and other biochemical indexes. This project had great~     significance to reveal molecular genetics mechanism in the development of salt,~     salt-sensitive and hypertension.~   "
10841|NCT02915302|"~     The aim of the study is to describe the safety and immunogenicity of the 0.5-mL dose (15 μg~     HA per strain) of Fluzone Quadrivalent vaccine in children 6 through 35 months of age.~      Primary objective:~        -  To compare the rate of any fever (temperature ≥ 100.4°F [38.0°C]) following the 0.5-mL~          dose of Fluzone Quadrivalent vaccine to that following the 0.25 mL dose of Fluzone~          Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2~          combined) in subjects 6 to < 36 months of age.~      Secondary objective:~        -  To compare antibody responses induced by the 0.5-mL dose of Fluzone Quadrivalent~          vaccine to those induced by the 0.25-mL dose of Fluzone Quadrivalent vaccine as~          assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after~          the final vaccination in subjects 6 to < 36 months of age.~      Other objectives:~        -  To describe the safety of 2 different dose levels of the 2016-2017 formulation of~          Fluzone Quadrivalent vaccine in subjects 6 to < 36 months of age.~        -  To describe the immunogenicity of 2 different dosages of the 2016-2017 formulation of~          Fluzone Quadrivalent vaccine in subjects 6 months to < 36 months of age.~        -  To submit available sera from approximately 30 subjects to the Center for Biologics~          Evaluation and Research for further analysis by the World Health Organization, the~          Centers for Disease Control and Prevention, and the FDA to support formulation~          recommendations for subsequent influenza vaccines.~   "
10842|NCT02915289|"~     Endometritis, an infection of the uterus in the postpartum period, has been shown to~     complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal~     cleansing prior to cesarean delivery has been shown to minimize the presence of~     micro-organisms and risk of infection. Although povidone-iodine is the most commonly used~     anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's~     diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine~     gluconate, on the other hand, has demonstrated superior disinfectant properties in several~     clinical trials, as compared to povidone iodine. In this randomized, comparator controlled,~     study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for~     intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.~   "
10843|NCT02915276|"~     For the purpose of this study, the investigators will perform the removal of trophectoderm~     (TE) the cells as required for the purpose of pre-implantation genetic screening, in order~     to perform the genetic analysis. Additionally, the investigators will remove the~     blastocoelic fluid (BF) and perform additional genetic analysis on the embryo in order to~     determine the agreement of the genetics results between TE cells and BF.~   "
10846|NCT02915237|"~     Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits~     such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for~     GWI currently available, there is an urgent need to develop novel interventions to alleviate~     major GWI clinical complications. Recent evidence highlights the potential value of~     flavonoids, a subclass of organic chemical called polyphenols abundantly found in some~     plants and common dietary preparations, in helping relieve clinical complications in~     Veterans with GWI. The overall goal is to test whether daily consumption of commercially~     available Concord grape juice, which is very Flavonoid-rich, is effective for treating~     cognitive deficits and chronic fatigue in Veterans with GWI.~   "
10847|NCT02915224|"~     This multicenter, single arm, non-interventional, observational study will evaluate the~     efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic~     lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total~     length of the study is 42 months.~   "
10848|NCT02915211|"~     To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years~     and over, with intractable epilepsy or Glut-1 DS on a KD.~   "
10849|NCT02915198|"~     This research will help us to learn if the medicine called metformin reduces the risk of~     death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood~     vessel problems.~   "
10850|NCT02915185|"~     A substantial proportion of individuals are left with poor residual functioning of the~     affected arm after a stroke. This has a tremendous impact on the quality of life and the~     ability for stroke survivors to live independently. While exercise is considered essential~     to any rehabilitation program, its benefits are generally far from optimal because of the~     lack of proper dosing in terms of intensity. One way to tackle this problem is to develop~     better tools that could predict an individual's potential and then adjust the intensity of~     exercise accordingly. One such predicting tool exists and consists of using non-invasive~     brain stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity~     of descending motor pathways originating from the brain. TMS consists of applying a magnetic~     wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal~     of the current proposal is to use TMS to test the integrity of the motor pathway in chronic~     stroke survivors. The level of responses to TMS will be used to classify participants in~     terms of potential for recovery and then, to determine the optimal level of exercise. The~     study will also examine the effect of another non-invasive brain stimulation technique~     called transcranial Direct-Current Stimulation—tDCS to determine whether it can enhance the~     response to strength training exercise in the affected arm. Half of the participants will be~     trained with the tDCS on, while the other half will be trained with the stimulator off. The~     training program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures~     will be performed to determine the impact of the strength training intervention on~     participants. Overall, the proposed project is expected to have a positive and significant~     impact on stroke survivors' quality of life.~   "
10851|NCT02915172|"~     There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).~      The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The~     goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found~     in Phase 1 can help to control advanced cancer.~      The safety of this drug combination will be studied in both phases of the study.~   "
10852|NCT02915159|"~     The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in~     patients with Sjögren's Syndrome.~   "
10853|NCT02915146|"~     Narrowband ultraviolet B phototherapy is the standard phototherapy for atopic eczema;~     ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the~     most important chromophores in treating atopic eczema; in which phototherapy is thought to~     work by improving epidermal barrier function, having beneficial effects on skin microbiome~     and local immunosuppression. It seems plausible that there are several chromophores and that~     'targetting' several at once with different wavebands should help and for severe eczema that~     has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is~     sometimes used. This study is to test if the combination is moderately to greatly more~     effective than narrowband ultraviolet B monotherapy amongst patients referred for any form~     of first-line phototherapy for atopic eczema.~   "
10854|NCT02915133|"~     Macular foveoschisis (MF) is a common complication of pathological myopia, which is~     characterized by choroid-retinal degeneration and vision impairment. Although pars plana~     vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion~     of recurrent MF due to the extremely long global axial length and posterior staphyloma.~     Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior~     staphyloma, and has been proven an effective method for treating MF. Optical Coherence~     Tomography (OCT) is widely used for the structural analysis of MF. Multifocol~     electroretinogram (mfERG) is an objective examination for visual evaluation. To our~     knowledge, there is a lack of data on the comprehensive visual function evaluations of MF~     patients associated with OCT findings. Our clinical trial aims to provide the structural and~     functional relationship in MF patients undergoing MB surgery, and find out potential factors~     to determine the visual prognosis.~   "
10855|NCT02915120|"~     The purpose of this study is to determine if patients with chronic painful knee~     osteoarthritis experience meaningful and long-term improvement in pain, function, and~     analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves~     following a double diagnostic genicular nerve blocks.~   "
10856|NCT02915107|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX~     STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting~     BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients~     with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous~     coronary intervention (PCI).~   "
10857|NCT02915094|"~     Objective of the study is to gain knowledge about the administration of Kineret in patients~     with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In~     the current survey, the investigation of the response rate of Kineret regarding the date of~     onset of action, the efficacy, as well as the tolerability and safety are of particular~     interest.~   "
10859|NCT02915068|"~     The investigators propose to modify and expand the internationally-recognized evidence-based~     Physician Asthma Care Education (PACE) program to make it a suitable tool for training~     primary care clinicians on the effective use of EHRs at the point of care. The investigators~     will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review~     of best practices for clinicians interacting with patients in the presence of computer~     systems in the exam room. They will then establish the feasibility and potential impact of~     EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the~     intervention on the following outcomes via survey 3 and 6 months post-intervention: patient~     satisfaction with the physician's performance, asthma control, and asthma-related quality of~     life. Outcomes will be assessed on patients, but physicians will receive the intervention.~     Patients will not know which arm their doctor was randomized to. The pilot trial will~     compare two groups of primary care physicians who see patients with asthma in clinics~     equipped with certified EHRs. It is hypothesized that patients of physicians who receive~     EHR-PACE training will achieve better outcomes compared to physicians who do not receive~     EHR-PACE.~   "
10860|NCT02915055|"~     This will be a single-center, prospective observational study. The study will compare~     post-operative pain scores and narcotic consumption between two groups of patients - one~     cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other~     cohort will receive only Percocet. Both pain management options are considered to be~     standard of care.~      The primary objective of the study is to compare patients' reported pain and narcotic use~     following meniscectomy, and determine if NSAIDs can provide adequate pain relief.~   "
10861|NCT02915042|"~     The primary objective of this study is to evaluate the efficacy of administering intravenous~     dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of~     opioids as measured on a weight adjusted morphine equivalent basis.~   "
10862|NCT02915029|"~     People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD).~     CKD is associated with increased risks for heart disease and death. The burden of chronic~     kidney disease is increased among minority populations compare to Caucasians. The Zuni~     Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high~     rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed~     to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to~     assess the safety and efficacy of conducting a full-scale study to determine if home based~     care delivered by a collaborative team composed of community health workers and University~     of New Mexico faculty will decrease the risk for the development and the progression of CKD.~   "
10863|NCT02915016|"~     This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in~     combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent~     Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.~   "
10864|NCT02915003|"~     With the help of local focus groups, the investigators are designing and testing a website~     to help urban people have better access to health care through understanding their insurance~     options better. They hypothesize that once individuals engage with the website and go~     through all of its modules, they will: 1) become more informed consumers of the ACA and its~     health insurance options; 2) enroll in an insurance plan; and 3) better leverage the~     benefits of their existing plans.~   "
10865|NCT02914990|"~     The main objective of this study is to evaluate the safety and tolerability of BPI-15086.~   "
10866|NCT02914977|"~     In this pilot study, eligible patients will be treated with 5 days of low dose daunorubicin~     for one cycle only. Any patient who receives treatment on this protocol will be evaluable~     for toxicity. Each patient will be assessed for the development of toxicity at all scheduled~     visits (Days 1-5). Following participation on this brief pharmacodynamic trial, patients can~     then proceed to other conventional or investigational therapies, as clinically indicated.~   "
10867|NCT02914964|"~     The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and~     the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with~     relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow~     their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets~     for 24 weeks.~   "
10868|NCT02914951|"~     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder~     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,~     noncompliance, and aggression. The purpose of this study is to investigate~     cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum~     disorders and intellectual disability. This pilot study will include children with ASD and~     IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce~     complexity of activities during therapy sessions but retains all key elements and principles~     of CBT. Assessments of irritability and disruptive behavior will include clinical~     interviews, parent ratings and child self-report measures. Study participants will be asked~     to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social~     perception and emotion regulation before and after CBT.~   "
10869|NCT02914938|"~     The purpose of this study is to determine the minimum biologically effective dose of ME-401;~     determine the maximally tolerated dose of ME-401 and determine the dose limiting toxicities~     of ME-401. Secondary objectives to evaluate the safety profile and efficacy of ME-401.~   "
10879|NCT02914808|"~     The chroedem study is aiming to assess tissue and biomolecular components of chronic lower~     limb oedema (CO). The investigators working hypothesis is that according to the aetiology of~     CO, the proportion of oedema & composition of peri-oedema tissues (fat, muscle,~     fibrosis/inflammation) might differ and could at least in part explain differences in~     failure/success of compressive therapies from one patient to another. For that purpose, 24~     patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary~     lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological~     (genetic) testing.~   "
10932|NCT02914119|"~     Aim: To explore~        -  the frequency of use of objective neuromuscular monitoring for assessment of depth of~          neuromuscular blockade in general anaesthesia~        -  the incidence of residual neuromuscular blockade, and~        -  the timing of reversal of the neuromuscular blockade at the end of anaesthesia.~      We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia~     Information Management System (AIMS).~   "
10870|NCT02914925|"~     The purpose of this study is to assess the use of a commercially available arm weight~     supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy~     (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In~     addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy~     and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.~      This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for~     Children. Subjects will be recruited from the general population. A sample size of 10~     participants is required for the study. Minority and gender distributions of this study are~     expected to reflect the distributions in the general population of this region.~      Therapy: Participating children will have their unaffected arm placed in a sling. The sling~     is placed at the start of the day and the child is encouraged to have this on during all~     therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy~     sessions will include activities aimed at building motor learning skills.~      TMS will be used to map the brain. Participants will have MRI of the brain that is T1~     weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex~     while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere~     and an induced electrical current passed through the coil will create a magnetic pulse that~     stimulates the brain~      Children will be assessed using functional hand tests and TMS.~   "
10871|NCT02914912|"~     Patients suspected for chronic mesenteric ischemia shall be investigated With gastroscopy~     assisted laser Doppler flowmeter and spectrometer (GALS).~   "
10872|NCT02914899|"~     The purpose of this study is to improve the efforts of Community health workers (CHWs) by~     developing materials to help increase lung cancer screening in NYC Chinese taxi drivers who~     smoke or who have quit smoking within the past 15 years.~   "
10873|NCT02914886|"~     The purpose of this study is to investigate whether a zinc-free insulin is an effective~     treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump~     (CSII, continuous subcutaneous insulin infusion) therapy.~   "
10874|NCT02914873|"~     A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due~     to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative~     treatment only when and if signs of tumor progression occur. There are however a number of~     uncertainties in AS, the most important being when to initiate treatment. The investigators~     are therefore starting a large randomized multicenter trial testing a standardized active~     surveillance protocol with specified triggers for repeat biopsies and initiation of curative~     treatment. The standardized protocol is compared with current practice for active~     surveillance. The primary aim of the study is to reduce overtreatment and subsequent side~     effects, without increasing the risk of disease progression or prostate cancer mortality.~   "
10875|NCT02914860|"~     The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity~     in patients with different forms of atrial fibrillation and within a sub-group of healthy~     subjects.~   "
10876|NCT02914847|"~     Self-harm has substantial personal impacts as well as costs on the National Health Service~     (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire,~     this is a significant issue with the number of admissions to hospital for self-harm in young~     people being higher than the United Kingdom (UK) average. Treating underlying mental illness~     can lead to a reduction in self-harm, but these are long interventions for complex disorders~     and many people who self-harm are not under treatment for mental illness. Moreover, young~     people struggle to access traditional mental health services where these therapies are~     delivered. No short interventions specifically tailored for young people have been developed~     so far.~      The Imaginator project aims to address the urgent need for an effective and innovative~     short-term therapy for self-harm in young people. The investigators will pilot a new~     imagery-based psychological intervention for young people aged 16-25 who experience~     repetitive self-harm. Mental imagery (the experience of seeing through the mind's eye) can~     carry intense emotions (positive and negative), and imagining something can facilitate~     behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense,~     hard to manage emotions such as those associated with self-harm, and (ii) for promoting~     healthy behaviour. Our new intervention called Functional Imagery Training will support~     young people to imagine more adaptive behaviours to cope with the emotional distress that~     triggers self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just~     two sessions followed by phone support over three months.~      Moreover, the investigators will address the challenge of young people accessing and staying~     in therapy by using a smartphone app to support the therapy, as apps are widely used and~     favoured by this age group. The app will enable participants to continue with the strategies~     they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and~     self-empowerment.~   "
10877|NCT02914834|"~     This pilot study aims to determine if it is possible to perform acupuncture on women~     diagnosed with stable angina who have symptoms. The investigators want to determine if~     acupuncture reduces the pain and other symptoms of angina. The investigators also want to~     examine whether this study is acceptable to the participants, and by carrying out this study~     the investigators will be able to tell how many participants they will need in a future~     larger study to further test acupuncture to reduce the symptoms of angina in women.~   "
10878|NCT02914821|"~     The study will take place at a cafe managed by university dining services and is located in~     a university building adjacent to the psychology building. The cafe sells sugar-sweetened~     beverages and a variety of diet drinks. The campus dining services and the manager of the~     cafe have given investigators permission to tax their sugar sweetened beverages and will~     provide their sales data for a 12 week period.~      The investigators will introduce four arms to the experiment. One arm will be baseline data~     where business 'as usual' will be conducted and no price increases will be implemented on~     SSBs. In the general tax condition the investigators will introduce a 3 cent/ounce tax on~     the five SSB flavors the café offers. In the Pre-K tax condition the investigators will~     institute a 3 cent/ounce tax but will label the tax as proceeds going to Pre-K education.~     This is designed after the Philadelphia tax that was recently passed where funds were~     earmarked to benefit childhood education. In the childhood healthy eating program condition~     the investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going~     toward childhood healthy eating programs. In all tax conditions the firm will keep the~     proceeds, but the research team will make a donation to a Pre-K education non-profit and a~     childhood healthy eating non-profit of the amount generated by the tax during the study~     period.~      Each experimental arm will run for 3 weeks total (for a total study period of 12 weeks). The~     conditions will alternate by week (i.e., week 1: business as usual; week 2: general tax;~     week 3: pre-K tax; week 4: childhood healthy eating tax; week 5: business as usual, etc). A~     research assistant will visit the café each week to make any necessary changes to signs that~     will label the drinks.~      The investigators will change the signage of the drinks in the cooler during the study~     period. For the baseline period there will be no changes to the signs made. Currently all~     beverages are labeled with their name and cost (e.g., Pepsi, $1.89). In the tax conditions~     the investigators will change the price of the drink (3 cents/ounce) and add a line~     notifying consumers of the soda 'surcharge' (note surcharge will be used in the study~     because no tax was actually passed by the local government). An example of this sign would~     be 'Pepsi, $2.29, includes 40 cent sugary drink surcharge.' In the Pre-K tax condition an~     added line will say, Pepsi, $2.29, includes a 40 cent sugar sweetened beverage surcharge.~     Proceeds benefit Pre-K education. In the childhood healthy eating programs condition the~     text will say, Pepsi, $2.29, includes a 40 cent sugary drink surcharge. Proceeds benefit~     Childhood Healthy Eating programs.~   "
10916|NCT02914327|"~     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of~     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome~     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the~     addition of SNX-5422 to an established dose of ibrutinib will result in the removal of~     mutated BTK from blood mononuclear cells and/or prevents or delays disease progression of~     subjects with CLL~   "
10880|NCT02914795|"~     Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are~     due to myocardial infarction. Almost all patients are initially diagnosed and treated in the~     cath lab. Therapy usually consists of one or more stent implantations. After implantation of~     a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet~     inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge~     of the individual platelet function is valuable.~      Several factors potentially promote a delayed or reduced mode of action of platelet function~     inhibitors in resuscitated patients:~        1. oral administration is impossible and medication needs to be administered via a gastric~          line.~        2. gastric absorption is delayed after resuscitation~        3. according to current guidelines patients are treated with therapeutic hypothermia.~          Including the time of rewarming cooling period is ~48h~   "
10881|NCT02914782|"~     Critically ill patients need intravenous fluid therapy in order to correct or prevent~     problems with their fluid and/or electrolyte status and for renal protection. The decision~     for the optimal composition and amount of IV-fluids can be difficult and complex. It is well~     known that errors in fluid- and electrolyte management contribute to overall morbidity and~     mortality. For decades, urinary sodium was used to diagnose renal disease. Nevertheless,~     renal excretion of sodium is largely impaired in critically ill patients, particularly in~     patients with acute kidney injury. Due to the high frequent measurement of renal output, it~     would be possible to measure the urinary electrolytes and its relative changes. Urinary~     electrolyte measurement may alert for the presence of the development of an akute kidney~     injury before occurring increases in creatinine or oliguria. The rationale of this~     investigation is therefore to collect data related to fluid- and electrolyte management from~     critically ill patients in order to find patterns of fluid- and electrolyte imbalances which~     may lead to disturbances and further, may allow an early detection of acute kidney injury.~   "
10882|NCT02914769|"~     The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant~     depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians.~     Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana~     (Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a~     serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A),~     such as harmine, harmaline. The study is designed as a randomized placebo controlled trial~     with two parallel arms, and it will also evaluate changes of different biomarkers of~     depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum~     levels of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological,~     psychiatric scales and questionnaires.~   "
10883|NCT02914756|"~     Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery~     from severe sepsis/septic shock, similar to what has been observed in mice? Do patients~     recovering from severe sepsis/septic shock suffer from cognitive impairment and is such~     impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from~     patients recovering from critical illness without prior sepsis?~   "
10884|NCT02914743|"~     The purpose of this research intervention is to assess the oral health status and~     periodontal health of patients with diabetes hospitalized on a general medicine service, and~     to assess the effect of providing dental prophylaxis and motivational interviewing to~     patient health-seeking behaviors and provider attitudes towards oral health, as well as on~     patient health outcomes.~   "
10885|NCT02914730|"~     In this cross-sectional study we will examine two populations: young adults with (ages~     18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin injections~     per day. The sample size for this observational study will be up to 125 patients. We will~     issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar~     Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen~     plunger and automatically sends confirmation of dose delivery to a smartphone app.~   "
10886|NCT02914717|"~     Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal~     inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and~     abdominal pain. Both infliximab and adalimumab have been used with success for~     moderate-to-severe UC refractory to conventional therapy. More recently, golimumab, another~     anti-TNF antibody, has been added to the treatment armamentarium.~      In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with~     moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50~     mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more~     frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients~     randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through~     week 54 significantly more often than patients randomized to placebo. Data on the use of~     golimumab in daily clinical practice are unavailable.~      The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term~     outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will~     be steroid-free golimumab continuation at week 26. Secondary endpoints will include~     (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal~     healing, (steroid-free) complete mucosal healing hospitalization-free survival, and~     colectomy-free survival.~   "
10887|NCT02914704|"~     MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and~     effective method in treating uterine fibroids and also adenomyosis. However, systematic~     studies on the effect of this treatment on factors affecting fertility are still lacking.~     Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this~     study is to obtain more information on the systemic response of the body to the~     HIFU-treatment when treating non-malignant disease as well as to study the effect of~     MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or~     adenomyosis and with no wish for further pregnancies will be selected for this study and~     treated using MRI-HIFU. The severity of symptoms will be assessed with UFS-QoL and the same~     questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood,~     urine and endometrium samples will be collected pre- and postoperatively and during~     follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of~     the immunological, inflammatory and hormonal response will be performed. As this is the~     first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a~     report about the efficacy of the MRI-HIFU in treating the uterine disorders will be~     published, and a key tool in assessing the treatment outcome would be the UFS-QoL~     questionnaire.~   "
10888|NCT02914691|"~     Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A~     part from reducing blood glucose, systemic blood pressure and albuminuria are decreased,~     while natriuresis is increased.~      Previous research into urinary peptide patterns (proteomics) has revealed that patients in~     risk of progressive renal disease display a risk peptide pattern in their urine, ahead of~     decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk.~      The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but~     long term randomized trials are ongoing. By investigating the impact of dapa treatment on~     this peptide pattern, it will be determined whether this intervention can improve the~     urinary proteomic peptide pattern. In addition new knowledge regarding renal processes that~     the treatment influences is sought.~      The impact of treatment of urinary and tubular markers of oxidative stress and function~     (metabolomics) will be assessed. These markers are thought to represent one of several~     deleterious pathways involved in the pathology of diabetic renal disease, and here the~     impact dapa treatment will be investigated. Improvement of these markers of oxidative stress~     may indicate long-term benefit.~      Objective: The primary objective is to assess the impact of three months of treatment with~     dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of~     diabetic comorbidity.~      Design: Double blinded, randomized, placebo-controlled crossover, single center study.~     Treatment period: 2 x 12 weeks.~      Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in~     accordance with the study in- and exclusion criteria.~      Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the~     effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes,~     microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2.~      Secondary endpoints are the effect of the intervention on other markers for tubular~     function, inflammation, endothelial dysfunction, microcirculation, kidney function,~     albuminuria, vasoactive hormones in plasma, and effect on global longitudinal strain as~     measured by echocardiography.~      Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last~     patient is expected to be completed October 2016. Data analysis completed December 2016,~     presentation autumn 2017 and publication early 2018.~   "
10889|NCT02914678|"~     In a previous study the investigators evaluated the apparent efficacy and safety of~     intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4)~     out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe~     pain [numeric rating scale (NRS, 0-10) > 3] at hospital arrival. The number of patients with~     possible fentanyl-related side effects was low.~      Therefore, the aim of the present study is to explore the efficacy and safety of a~     liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per~     transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport).~     The investigators hypothesize that:~        -  A higher proportion of patients will experience sufficient pain relief at hospital~          admission (NRS < 4) using the liberalized protocol and~        -  There will be no differences in the proportion of potential fentanyl related~          side-effects are observed.~   "
10890|NCT02914665|"~     This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac~     and renal effects of short term treatment with elamipretide in patients hospitalized with~     congestion due to heart failure~   "
10891|NCT02914652|"~     The overall objective for this study is to test whether β2-agonists will affect the~     cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and~     healthy age- and gender-matched controls.~   "
10892|NCT02914639|"~     The primary purpose of this study is to evaluate the safety and exploratory efficacy of~     SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular~     Degeneration (AMD).~   "
10893|NCT02914626|"~     Neovascular glaucoma is a potentially blinding condition characterized by the growth of~     newvessels at the anterior part of the eye. This growth is driven by the overexpression of a~     protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as~     diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular~     pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order~     to decrease VEGF formation. The investigators postulate that the use of anti-VEGF~     intravitreal injections may accelerate recovery and decrease the need of surgery in cases of~     neovascular glaucoma.~   "
10894|NCT02914613|"~     The primary purpose of this study is to evaluate the safety and exploratory efficacy of~     SF0166 Topical Ophthalmic Solution in patients with Diabetic Macular Edema (DME).~   "
10895|NCT02914600|"~     The primary objective of this study is to observe the long-term safety of filgotinib in~     adults who have completed or met protocol specified efficacy discontinuation criteria in a~     prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).~   "
10896|NCT02914587|"~     To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair~     follicle implantation method following a nine month period of post-procedure evaluation.~   "
10897|NCT02914574|"~     This study primarily aims to investigate arthrogenic muscle inhibition (AMI), an underlying~     mechanism in patellofemoral pain (PFP), which remain to date understudied. Although, studies~     have revealed that AMI needs to be eliminated before improvements in muscle strength can be~     achieved, to date quadriceps muscle inhibition in patients with PFP remains understudied. To~     date the influence of AMI on functional performance and the direct link to pain in patients~     with PFP remain unclear. This study aims to investigate the link between AMI to pain,~     functional performance and how an acute treatment can affect functional performance and~     pain.~   "
10898|NCT02914561|"~     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib~     during induction and maintenance treatment of moderately to severely active Crohn's disease~     (CD) in participants who are biologic-naive and biologic-experienced.~      Participants who complete the study, or do not meet protocol response or remission criteria~     at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead~     Study GS-US-419-3896).~   "
10899|NCT02914548|"~     The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in~     patients with atopic dermatitis.~   "
10900|NCT02914535|"~     The primary objective of this study is to observe the long-term safety of filgotinib in~     adults who have completed or met protocol specified efficacy discontinuation criteria in a~     prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).~   "
10901|NCT02914522|"~     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib~     in the induction and maintenance treatment of moderately to severely active ulcerative~     colitis (UC) in participants who are biologic-naive and biologic-experienced.~      Participants who complete the study, or do not meet protocol response or remission criteria~     at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead~     Study GS-US-418-3899).~   "
10902|NCT02914509|"~     To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost~     drug product, placed in the canaliculus of the eyelid in the treatment of subjects with~     open-angle glaucoma or ocular hypertension.~   "
10903|NCT02914496|"~     For many people living with type 1 diabetes it is a challenge to achieve good glucose~     control. Barely 20% reaches the goal level and many people experience self-care as complex,~     demanding and stressful. The purpose of this study is to evaluate the effect of a~     stress-management program on glucose control, self-care and psychosocial factors. The~     program is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive~     behavior therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta~     hospital will be recruited. Half of them will receive the intervention and the other half~     will continue with their regular diabetes care. A licensed psychologist specialised in CBT~     and a diabetes specialist nurse will be leading the intervention that is given in a group~     format. The program consists of seven 2-hour sessions given over 14 weeks. Glucose control,~     self care and stress will be measured at inclusion, after session four and seven, at six ,~     12 and 24 months and finally after 5 years~   "
10904|NCT02914483|"~     The Women's HARP study is a multi-center study focusing on women with clinical presentation~     of myocardial infarction (MI). Women will complete stress questionnaires following~     presentation to the medical center with elevated cardiac enzymes and abnormal~     electrocardiograms (ECGs). 2 months following MI, participants will be screened for the~     Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported.~     After completing baseline assessments, participants will be randomized to Enhanced Usual~     Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.~   "
10905|NCT02914470|"~     This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of~     carboplatin and cyclophosphamide, in combination with atezolizumab.~   "
10906|NCT02914457|"~     The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by~     multipoint LV pacing (either simultaneously or sequentially) in comparison to the response~     achieved by the current (standard) BiV pacing configuration in patients~     indicated/recommended for cardiac resynchronization therapy.~   "
10907|NCT02914444|"~     Monitoring data during anesthesia of surgical patient in the operation room will be~     collected and stored into the registry automatically. Patients' information and preoperative~     assessment from medical records will be included. Furthermore, intraoperative events will~     integrated and entered in the registry.~      The purpose of the registry is to establish an automatic and accessible database of surgical~     patients for further retrospective studies.~   "
10908|NCT02914431|"~     The purpose of this study is to determine whether personalized titanium plates can achieve~     better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic~     surgery, and evaluate the feasibility of this technique in clinical application.~   "
10909|NCT02914418|"~     This study will investigate how repetitive transcranial magnetic stimulation (TMS) using~     intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such~     as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows~     non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of~     this study will be to assess the feasibility of using TMS with iTBS paradigm to treat~     sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper~     limbs.~   "
10910|NCT02914405|"~     Neuroblastoma, the most common extra-cranial solid tumour in children, remains one of the~     major challenges in paediatric oncology. A promising way to further improve outcome in this~     disease appears to be the development of adjuvant therapeutic strategies. In this research~     the anti-GD2 antibody, which is a standard treatment, is to be combined with 131-l~     Metaiodobenzylguanidine (mlBG) and anti-Programmed Cell Death Protein 1 (anti-PD1) antibody~     Nivolumab - the investigated drugs - with the aim of generating sustained anti-neuroblastoma~     immunity. In particular it will be determined the safety and tolerability of the novel~     combination as well as documented any evidence of efficacy in paediatric patients with~     relapsed and refractory high risk neuroblastoma.~      This study is sponsored by the University Hospital Southampton and will take place in 4~     hospitals in the United Kingdom, Germany and USA. The estimated duration of the study is 2~     years, starting in December 2016.~      This is an adaptive study. Such design uses accumulating of data from the ongoing trial to~     modify aspects of the study (e.g. duration, number of treatments) without undermining its~     validity or integrity. There will be 3 cohorts of patients. As safety of Nivolumab is well~     established, Cohort 1 will assess its safety and tolerability in combination with 131-l~     mlBG. Cohort 2 will then add anti-GD2 to the drug combination, assessing safety and~     tolerability. Cohort 3 will escalate all 3 agents to the full 100% dose level to assure~     safety for expanded analyses of clinical and laboratory data at that dose level.~      Patients will initially be recruited into Cohort 1. Patients must have completed at least 12~     weeks of trial treatment without reaching a Dose Limiting Toxicity before a patient can be~     recruited to the next cohort.~      A minimum of 3 evaluable patients will be treated in cohorts 1-3. Assuming the full dose~     combination therapy (cohort) is tolerable, 15 evaluable patients will be treated.~   "
10911|NCT02914392|"~     The objective of this study is to research the relationship between maternal exposure to~     environmental factors and fetal congenital heart disease in a community-based case-control~     study.~   "
10912|NCT02914379|"~     The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how~     long it takes the body to get rid of it. In addition, the safety and tolerability of the~     study drug will be evaluated.~      Participants will be admitted to a clinical research unit (CRU) the day before dosing.~     Participants remain confined to the CRU for at least 7 days. Participants may be discharged~     from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days~     post-dose (Day 22).~      This study will last approximately 30 days for each participant, not including screening.~     Screening is required within 28 days prior to the start of the study.~   "
10913|NCT02914366|"~     The present study will test the hypothesis that the medication Ambroxol is safe and well~     tolerated and will improve cognitive and motor symptoms of Parkinson's Disease Dementia~     (PDD). Ambroxol has been shown to raise the levels of the enzyme beta-glucocerebrosidase~     resulting in lower the levels of the protein alpha-synuclein, both of which have been shown~     to improve cognition in mouse models. This will be a 52 week trial of Ambroxol in 75~     patients with PDD. Patients will undergo clinical, neuropsychological and neuroimaging~     assessment throughout the study to assess changes.~   "
10914|NCT02914353|"~     This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic~     profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV~     administration of single ascending doses in healthy normal volunteers, and following~     continuous IV infusions of multiple ascending doses in healthy normal volunteers.~   "
10915|NCT02914340|"~     This is a multicenter, prospective study designed to evaluate performance of the SVS in the~     REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12~     sites with up to 6 patients per site.~   "
10918|NCT02914301|"~     Prenatal care is defined as preventive healthcare characterized by regular check-ups by~     doctors or midwives to treat and prevent potential health problems throughout the course of~     the pregnancy. The investigators propose that a mobile app for prenatal care has the~     potential to provide patient-tailored, risk-appropriate prenatal educational content and may~     facilitate vital sign and weight checks between visits. The investigators describe the~     methods used to develop and test the effectiveness of a mobile app for prenatal care to~     safely reduce the number of in-person visits to the obstetrician (OB) compared to standard~     of care.~   "
10919|NCT02914288|"~     Intracranial artery disease has been more detected with development of HR-MR. HR-MR can~     depict vascular wall directly and give us more information beyond the pre-existing imaging~     modalities such as digital subtraction angiography, magnetic resonance angiography, computed~     tomography angiography. Hence, HR-MR is considered to become promising imaging modality for~     intracranial artery disease and many studies have been published recently. However, there~     was not enough to differentiate various intracranial artery disease such as atherosclerosis,~     dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real~     clinical arena, intracranial artery disease is too difficult to diagnose and distinguish~     among the disease. Of the disease, usefulness of HR-MR has been consistently published in~     the detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be~     the most important and reliable imaging method in intracranial artery dissection as of now.~     Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial~     artery dissection is dynamic vascular pathology. The geometric change is the most common~     among intracranial artery disease. However, there was no report about the geometric change~     in HR-MR. The investigators acquired retrospective data about the natural course of~     intracranial artery dissection in HR-MR and are preparing for publishing an article.~     However, the data is not prospective and not intraindividual comparison. Therefore,~     reliability is not enough to convince the natural course. If the investigators got~     prospective and intraindividual data, definite natural course of intracranial artery~     dissection could be acquired and would be helpful to diagnose the dissection and~     differentiate from other vascular pathologies. The prospective longitudinal information from~     this study could guide us as the important map on the confusing HR-MR findings. The~     protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month~     (optional), 12 month.~   "
10920|NCT02914275|"~     This is a study to assess the immune (antibody) response and safety of a Seqirus split~     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US~     licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric~     population 6 months through 59 months of age.~   "
10921|NCT02914262|"~     This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I~     study in healthy male subjects.~   "
10922|NCT02914249|"~     This study aimed to verify if combination of a low calorie diet and orange juice consumption~     results in weight loss and ameliorates metabolic obesity-related biomarkers.~   "
10923|NCT02914236|"~     Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.~   "
10924|NCT02914223|"~     The main objective of the study is to investigate the rate and routes of elimination of~     cenerimod and the mass balance in urine, feces, and expired air~   "
10925|NCT02914210|"~     The goals of this research study are the following:~        1. To compare the effects of tele-rehabilitation-supported physical therapy versus~          traditional home and/or clinic-based physical therapy for total knee replacement on~          90-day health service use costs.~        2. To compare tele-rehabilitation-supported physical therapy and traditional physical~          therapy on patient-centered outcomes~        3. To explore whether individual patient characteristics are associated with differential~          improvement from 6 to 12 weeks assessed by patient-reported outcomes.~   "
10926|NCT02914197|"~     To trial the provision of full information on the benefits and risks of mammography in women~     that are eligible for breast screening. The knowledge many women have of mammography is not~     reflective of the recent change in evidence; it is often missing information on~     over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer~     and the benefits of breast screening. In addition, universal breast screening programs are~     biased towards emphasizing screening. However, a mammogram is not a perfect test and there~     is no right or wrong decision about whether to have a screening mammogram. It is an~     individual woman's decision to make. To understand the effect of changing information to~     reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic~     controlled trial of implementation of balanced information on mammography in family~     practice.~   "
10927|NCT02914184|"~     The purpose of this study is to evaluate the clinical consistency of three production lots~     of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human~     rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as~     compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of~     immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in~     healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the~     extension phase of the study~   "
10928|NCT02914171|"~     The objective of this study is to determine the safety and feasibility of autologous~     mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial~     delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to~     the control group undergoing the same surgical procedure without cell delivery. This add-on~     procedure has the potential to foster a new strategy for individuals with congenital heart~     disease.This is an open-label study of autologous MNC derived from bone marrow with a 2-year~     follow-up to document 1) incidence and severity of adverse event and 2) monitor changes in~     cardiac structure and function.~   "
10929|NCT02914158|"~     The objective of this study is to compare the curative effects in patients under the age of~     35 with hormone receptor positive breast cancer and high recurrent risk factors including~     large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus~     aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the~     differences of curative effects between different subtypes to provide direct evidence for~     treatments of young breast cancer patients.~   "
10930|NCT02914145|"~     In line with the global and regional efforts towards malaria elimination, a five year~     program was established to assist the NMCP in adopting targeted evidence-based elimination~     plans through a 'learn by doing' strategy. The project aims to generate knowledge as data is~     generated to inform the programmatic aspects of the elimination plan, most importantly how~     to clear malaria parasites from the asymptomatic reservoir.~   "
10931|NCT02914132|"~     The purpose of this study is to determine whether the Seraph® Microbind® Affinity Blood~     Filter is safe in the treatment of dialysis patients with bacteremia from Staphylococcus~     aureus.~   "
10996|NCT02913248|"~     The purpose of the present investigation is to record and compare bacterial compositions in~     subgingival plaque samples and saliva samples in subjects receiving periodontal treatment.~     The hypothesis is that the composition of the salivary microbiota might reflect local~     bacterial alterations in relation to periodontal treatment.~   "
10933|NCT02914106|"~     Despite several scientific and technological advances, there is no single neuroprotective~     treatment that can reverse the brain damage after acute ischemic stroke (AIS). Neuroactive~     steroids are cholesterol-derived hormones that have the ability to modulate the normal and~     pathologic nervous system employing genomic and non genomic mechanisms.~      In this work, we first investigated if AIS affects the plasma concentration of five~     neuroactive steroids (cortisol, estradiol, progesterone, testosterone and 3-alpha~     androstenediol glucuronide). Second, we studied if levels of circulating steroids associate~     with neurological, cognitive and functional outcome in a cohort of 60 to 90 year-old male~     and female patients with AIS.~      For this purpose, we recruited patients who were hospitalized at the Emergency Room of the~     Central Military Hospital within the first 24 hours after stroke onset. We designed two~     experimental groups, each one composed of 30 control subjects and 30 AIS patients, both~     males and females. The assessment of neurological deficit was performed with the NIHSS and~     the tests used for the functional and cognitive status were: (1) modified Rankin Scale; (2)~     Photo test and (3) abbreviated Pfeiffer's mental status questionnaire.~   "
10934|NCT02914093|"~     The overall objective of the study is to investigate the feasibility of home based~     inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and~     to examine the relationship between inspiratory muscle strength and carbon dioxide level.~   "
10935|NCT02914080|"~     Social isolation and loneliness of the elderly have become major public health problems,~     because of the deleterious consequences if not lethal they can generate.~      Because of frequent resignation to these phenomena, support must be given to all means of~     prevention to prevent or at least mitigate their impacts. It appears from the literature~     that are isolated or living as they have adjustment difficulties which are linked to~     fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria,~     psychological fragility criteria have been little discussed outside of psychiatric disorders~     (depression, anxiety disorders in particular).~      This study aims to test in the elderly in isolation psychological fragility questionnaire~     and to study the statistical qualities and relations with socio-demographic variables,~     environmental and other known vulnerabilities.~   "
10936|NCT02914067|"~     The investigators will focus on two cohorts of brain tumor patients aged, 4-18 years, to~     answer two critical questions: 1) Can the investigators acquire high quality data relevant~     to cognitive function during the peri-diagnostic period and, 2) can the investigators~     develop predictive models for cognitive outcomes using serial examination of functional~     imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18~     will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors~     of the posterior fossa will be eligible for cohort 2. The rationale for of the focus on~     these patients is that first, the posterior fossa is the most common location for pediatric~     brain tumors and therefore this focus will impact the largest segment of this patient~     population. Second, three tumors commonly occur here, medulloblastoma, ependymoma and~     pilocytic astrocytoma. These are treated with surgery, radiation and chemotherapy~     (medulloblastoma), surgery and radiation therapy (ependymoma) or surgery only (pilocytic~     astrocytoma). Thus, this focus will provide a platform to analyze the impact that different~     tumor types and different standard treatments have on cognitive dysfunction. Finally, the~     fact that all subjects will have tumors of the same brain region will control for the effect~     that tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations~     on and off therapy will provide the necessary data points to establish trajectories of~     cognitive development and recovery in this population.~   "
10937|NCT02914054|"~     In this prospective, randomized, controlled clinical trial investigators' aim was to compare~     the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional~     treatment with PDN for untreated adult patients with ITP. In this study standardized~     criteria and definitions were used according to consensus international working group~     guideline for ITPto compare clinical outcomes of the two corticosteroid treatment regimens~     and determine the superior regimen as a first line strategy for new primary ITP in adults~   "
10938|NCT02914041|"~     Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of~     the tools to discriminate the functional ability impairments relating to kyphosis when~     compare with gold standard (Cobb's method), and compare among physical therapy, VHS and~     caregiver?~   "
10939|NCT02914028|"~     Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain.~     Transversus abdominis plane block is a current intervention to support postoperative~     analgesia, however it is recently in research area how to be applied in different surgical~     areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane~     block is not advised but has not been studied to be effective for postoperative analgesia in~     inguinal herniography patients.~      This study aims to research the effect of subcostal transversus abdominis plane block in~     subacute postoperative pain after inguinal hernia repair~   "
10940|NCT02914015|"~     This prospective, randomized study, control study aims to compare the analgesic effect,~     opioids consumption, quality of recovery, length of hospital stay and et al. between~     unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled~     analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal~     incision.~   "
10941|NCT02914002|"~     Comer en Familia is a psychoeducational intervention in nutrition aimed to improve~     nutritional status in families, particularly mothers and caregivers of children between the~     ages of 5 and 13 years and their children through providing healthy cooking lessons in their~     communities where the optimal preparation and use of local foods based on vegetables is~     promoted at the same time the importance of cooking at home and eating as a family is~     highlighted.~   "
10978|NCT02913482|"~     Open-label, multi-center clinical study is to assess the safety, tolerability,~     pharmacokinetic, pharmacodynamics, and efficacy of RO7034067 in infants with Type 1 spinal~     muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding part~     (Part 1) and a confirmatory part (Part 2) which will investigate RO7034067 for 24-months at~     the dose selected in Part 1.~   "
10993|NCT02913287|"~     The aim of the overall project is to investigate the potential of a combination of~     commercially available nutraceuticals produced by Marigot Ltd (natural seawater derived~     mineral-rich AquaminMG and seaweed-derived mineral-rich food supplement AquaminTM (FDA GRAS~     000028) isolated from Lithothamnion species), as safe and effective supplements to promote~     cognition in the aged brain.~   "
10994|NCT02913274|"~     Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the~     leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients~     incurring significant related costs estimated at over one billion dollars in the USA.~      Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as~     this is the least invasive procedure, the alternative being revision surgery. Angioplasty~     uses an inflatable balloon of various diameters. Different types of angioplasty balloons may~     be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or~     cutting balloons. These angioplasty procedures which are often painful during dilation have~     a high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26~     and 64% depending on the team and a mean rate estimated at 40% for the studies including the~     larger number of patients, some of whom requiring several procedures.~      These invasive repeated procedures impair the quality of life of these patients with~     end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and~     for whom vascular access patency is vital.~      Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation~     processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis~     access is the key factor in development of a new stenosis and hence a vicious circle of~     stenosis-angioplasty.~      For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel,~     Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for~     cancer chemotherapy, are released in small doses on the medical angioplasty devices. During~     inflation, the local release of the anticancer (antimitotic) molecule through the different~     layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local~     antiproliferative action without the systemic toxic effects associated with high-dose~     chemotherapy.~      These medical devices have demonstrated their efficacy in terms of increase in primary and~     secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal~     or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy).~      These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being~     indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has~     proven their medical effectiveness, and in particular their contribution in terms of patency~     rate improvement. However, studies on animal models show significant results regarding~     efficacy against neointimal hyperplasia and the first single-centre clinical trials on a~     small sample size appear promising.~      The key assessment criterion is primary patency of the dilated stenosis at one year defined~     by patients efficaciously dialysed at one year without re-intervention on the dilated lesion~     after initial angioplasty. The delay of occurrence of dilation will be considered (censored~     criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to~     follow-up…) will be censored at the date of the latest news.~   "
10942|NCT02913989|"~     Abstract: Tobacco dependence remains one of the primary health care concerns worldwide.~     Attitude of healthcare professionals towards smoking is crucial for any long-term prevention~     and smoking cessation program.~      Objectives: Analyze smoking habits of medical doctors from a central hospital in Lisbon~     (2014), comparing results between medical versus surgical specialities. Results were~     compared with those obtained in 1999.~      Design and setting: A voluntary and anonymous questionnaire was distributed to all~     physicians for a period of 4 months. The questions included sociodemographic data, smoking~     habits characterization, attitudes towards smoking, importance attribute to smoking~     cessation programme in the hospital and knowledge of the 2008 country law.~      Participants: All medical doctors working in the central hospital studied between 1/1/2014~     and 30/6/2014 Outcome measures: The primary outcome measure was to characterize the smoking~     habits of medical doctors. Secondary outcomes included comparison of results between~     surgical and medical groups and with those obtain in a similar study in 1999.~   "
10943|NCT02913976|"~     The aim of this study is to demonstrate that the application of Kinesio Taping on a~     myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an~     increase of the cervical range of motion in patients diagnosed with cervical pain.~   "
10944|NCT02913963|"~     The aim of this study is to demonstrate that the application of Kinesio Taping on a~     myofascial trigger point in the trapezius muscle able to cause a decrease of the trigger~     point pain and an increase of the cervical range of motion in asymptomatic subjects~   "
10945|NCT02913950|"~     There is a need to develop a stool scale for baby's and toddlers who are not potty-trained~     yet. The investigators try to get a uniform and approved Bristol stool scale for children~     who ware diapers.~   "
10946|NCT02913937|"~     The aim of this study is to compare the effect of passive ultrasonic irrigation versus~     needle irrigation on post-operative pain and healing in patients with permanent posterior~     teeth with apical periodontitis treated in a single visit.~   "
10947|NCT02913924|"~     The protocol is a double-blind, placebo-controlled inpatient and outpatient study, combining~     an inpatient model of cannabis withdrawal with a clinical treatment of cannabis use disorder~     using clonazepam versus placebo. 80 patients seeking treatment for cannabis use disorder~     will be enrolled into the inpatient phase for 5 nights. After discharge from the inpatient~     phase, 12-weeks of outpatient treatment will be conducted. This combined design will provide~     a comprehensive understanding of clonazepam's effects on individuals with cannabis use~     disorder across a range of outcome measures while also testing the medication's ability to~     prevent relapse in cannabis-abstinent patients.~   "
10948|NCT02913911|"~     -  Does the utility of external feedback in terms of goal-directed LLL approach during STS~          training immediately improve functional ability relating to walking in ambulatory~          patients with SCI?~        -  Does the utility of LLL feedback improve functional ability relating to walking in~          ambulatory patients with SCI after 2-week training?~   "
10949|NCT02913898|"~     This study will assess learning bias (the tendency to learn more from negative relative to~     positive outcomes) at baseline in 3 groups of participants (currently depressed, previously~     depressed and never depressed). It will then try to modify this bias using a simple~     computerised training task completed at home daily for 2 weeks. Outcome measures include~     symptoms of depression, cognitive measures (i.e. accuracy and reaction time during~     completion of tasks), pupillometry measures and salivary cortisol.~   "
10950|NCT02913885|"~     The aim of this study is to compare the effect of color change between remineralizing agent~     and guided enamel regeneration in treatment of white spot lesion after orthodontic~     treatments~   "
10951|NCT02913872|"~     What are the capacity and training needs in general practice to implement routine spirometry~     and eNO testing in children aged 5-16 years?~      Asthma is the commonest long-term disease of childhood in the United Kingdom (UK).~     Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been~     reported from several European countries including the UK. This can result in poor symptom~     control and increased risk of asthma related deaths.~      It has been suggested that both under- and over- diagnosis of childhood asthma in general~     practice could be improved by routinely using objective lung function testing for diagnosis~     and monitoring.~      The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements~     - eNO) are already used routinely in UK hospitals, but are not usually available in general~     practice where most children are cared for.~      Why is it important? - Availability of these tests will help health professionals in general~     practice to look after children with asthma better, and hopefully improve asthma control.~      What will this study achieve? - Though it is believed that providing spirometry and eNO in~     general practice would be beneficial, there is little data on how this can be achieved. This~     study will employ both qualitative and quantitative measures in order to evaluate the~     resources required to implement routine spirometry and eNO testing for children in primary~     care; and to investigate the impact this would have on diagnosis in children with suspected~     asthma.~      How? - The investigators will work with general practices in and around Leicestershire, UK.~     Firstly, to identify what the barriers are to implementing these tests, and secondly to~     train the practices to perform and interpret spirometry and eNO independently in children.~      Children with suspected or previously diagnosed asthma will be invited for review and lung~     function testing. The investigators will record the time it takes to train general practices~     to perform and interpret spirometry and eNO independently, and the additional clinic~     capacity required to provide these tests.~   "
10952|NCT02913859|"~     PART I~      Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer~      The goal of this clinical study PART I is to determine impact of radiotherapy treatment in~     combination with standard androgen deprivation therapy comparing with androgen deprivation~     therapy alone at controlling metastatic prostate cancer. The primary objective: to determine~     disease progression free survival in man with metastatic (M1) prostate cancer (PC)~     undergoing androgen deprivation therapy with or without definitive radiotherapy of the~     primary tumor.The secondary objective: to determine disease progression (local, bone marrow,~     visceral) in men with metastatic prostate cancer (M1PC) undergoing systemic therapy~     with/without definitive radiotherapy of the primary tumor, to determine expression in number~     of genes analysed 8: 2 housekeeping genes; integrin subunits αv, β3, β5, α4β1 ; 3 EMT~     markers N-cadherin, E-cadherin, vimentin before radiotherapy, after radiotherapy and at the~     time of the disease progression , to determine plasma serotonin (5HT, 5 hydroxytryptamine).~     Subgroup analysis in locally advanced prostate cancer (serves as a control group for~     integrins analysis): to determine expression in number of genes analysed 8: 2 housekeeping~     genes; integrin subunits αv, β3, β5, α4β1 ; 3 epithelial-mesenchymal transition (EMT)~     markers N-cadherin, E-cadherin, vimentin before radiotherapy, after radiotherapy and at the~     time of the disease progression.~      PART II~      Identification of genetic determinants of disease progression and castrate resistance in~     metastatic prostate cancer.~      The goal of this clinical study PART II is to assess feasibility of genomic testing in the~     multidisciplinary clinical management of metastatic prostate cancer, to gain insight in~     specific genomic signature(s) of progressive metastatic prostate cancer in the natural~     course of disease spanning from primary tumor to metastases, to test if 'treatment~     selection' and/or 'treatment adaptation' as means of evolutionary pressures represent the~     mechanistic models of castrate resistance and ultimate treatment failure following course of~     androgen deprivation therapy (ADT).~   "
10992|NCT02913300|"~     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly~     performed for diagnosis of mediastinal pathologies. The procedure can either be performed~     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients~     tolerate the procedure well although cough is often reported as a distressing symptom.~     Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no~     literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS~     TBNA. This study would help to determine whether 1% lignocaine is as effective as 2%~     lignocaine for airway anaesthesia during EBUS-TBNA.~   "
10953|NCT02913846|"~     Denutrition is defined as a measurable decrease in functions and/or as change in the body~     composition, associated with a worsening of the prognosis of the underlying medico-surgical~     pathology. It is induced by a deficiency in energy, proteins or any other micro or~     macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic~     disorder.~      According to the National Nutrition and Health Plan for Belgium, denutrition is an~     independent risk factor for the increase of complications, morbidity and mortality rates,~     average length of hospitalisation and global medical care cost. It is necessary to invest in~     the prevention of denutrition as the costs of preventive measures are lower than the cost of~     treating a denutrished patient.~      The Belgian financing system of hospitalisation days is based on the structure of the~     treated pathologies, the age of the patient and the geriatric features of the patient. It~     encourages all hospitals to lower the length of hospitalisation to the national average for~     all these criteria. As a consequence, there is a mounting tendency to shorten the average~     length of stay within the hospital.~      The so-called 'Sp' hospital departments occupy a specific place within the organisation of~     Health Services in Belgium. They are specialized in the treatment and rehabilitation of~     patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic~     diseases. These services act as an extension of acute services (continuity of acute~     hospitalisation) but also as a first entry point for the medical care of patients with~     various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary~     disorders...).~      The financing of the Sp departments is, as opposed to the financing of other departments,~     not linked to the patient length of stay. However, an increase in hospitalization duration~     decreases the rate of admissions and the possibility to accept patients coming from acute~     hospital units.~      The aim of the study is to evaluate the influence of denutrition of patients hospitalized in~     an Sp department on the length of revalidation stay, the associated costs and the patient's~     functional autonomy.~   "
10954|NCT02913833|"~     The financing of the Belgian hospitals is based on a system taking into account the length~     of hospitalization of a given patient according to his/her pathology, his/her age and~     his/her geriatric characteristics. This system encourages all hospital to lower the~     hospitalization duration to the national average for these criteria. This results in better~     efficiency in the management of hospitalizations but also means a swifter transfer to~     structures exempted from this system such as revalidation units, nursing homes and~     psychiatric units. An assessment of the differences in the medical practice, in terms of~     quality and outcomes of care, is essential for any reform willing to reduce medical costs.~      Pain management is part of the quality indicators within hospitals. Pain is defined by the~     International Association for the Study of Pain as an unpleasant sensory and emotional~     experience, associated to present or potential tissue damage, or described in terms of such~     a damage. Several studies have showed that pain affects the quality of life and impacts the~     daily activities. Acute or chronic pain can cause adverse symptoms such as sleep~     disturbance, appetite loss, decreased concentration, mood changes and the disruption of~     familial, work and social activities. Pain might also slow down revalidation processes. A~     study performed by Aprile et al showed that pain negatively influenced the rehabilitation~     program of a quarter of the patients having had a stroke. The functional recovery was slower~     and the costs were higher.~      The aim of this study is to determine if the systematic evaluation of the pain of a patient~     hospitalized in a revalidation unit has an impact on his/her length of stay.~   "
10955|NCT02913820|"~     Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for~     vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well~     as snowfall and changes in atmospheric pressure) will be correlated with the incidence of~     myocardial infarctions.~   "
10956|NCT02913807|"~     This study will test the accuracy of computerized custom mandibular reconstruction to~     traditional methods of mandibular reconstruction using a vascularized osteocutaneous fibula~     flap.~   "
10957|NCT02913794|"~     Fimasartan and Rosuvastatin for hypertension and dyslipidemia control~   "
10958|NCT02913781|"~     Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle~     with removal of the polar body just before the ICSI procedure and sperm injection at the~     site of polar body removal. This study group will be evaluated with another group with the~     classic ICSI procedure~   "
10959|NCT02913768|"~     Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is~     associated with hypotension and bradycardia, which may be deleterious to both parturient and~     baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an~     important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in~     intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of~     ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following~     subarachnoid block in parturients undergoing elective caesarean section.~   "
10960|NCT02913755|"~     Acquired Brain Injury (ABI) is damage to the brain caused by a head injury or~     illness/disease such as stroke or aneurysm. ABI is often associated with poor awareness into~     ongoing symptoms of damage to the brain, which can be cognitive, physical, and~     psychological. A multi-disciplinary rehabilitation programme is recommended to help with~     such symptoms. However, without self-awareness of difficulties, people with ABI can have~     poor motivation to take part. The study aims to discover whether showing people a short~     'preparatory' video about ABI rehabilitation has an effect on self-awareness, and their~     motivation to take part in rehabilitation offered to them.~      The study also aims to investigate the feasibility of using the preparatory video on a~     larger scale across inpatient ABI rehabilitation, by exploring whether staff find delivering~     the video easy to incorporate into routine practice.~      People invited to take part in the study will be recruited from a specialist inpatient brain~     injury rehabilitation unit (BIRT).~      People who are approached will be given information about what the study will involve, and~     can choose not to take part.~      Each participant will be asked to fill out a series of questionnaires. They will then be~     supported by staff to watch a short video every two/three days, over twelve weeks. Half of~     the participants will be shown the video right away, while the other half will wait six~     weeks, to allow for comparisons between the groups. The video will aim to improve~     understanding of the kinds of emotional and/or practical difficulties they may be~     experiencing, and will inform participants about what rehabilitation might be like. After~     they have regularly watched the video for twelve weeks both sets of participants will be~     asked to complete another set of questionnaires, and the staff will be asked to complete an~     evaluation of how they found delivering the video.~   "
10970|NCT02913625|"~     Locoregional anesthesia provides several advantages over general anesthesia in terms of~     postoperative pain, decreased postoperative opioid needs and reduced recovery time for~     patients undergoing orthopaedic surgery.~      For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally~     preferred because of its simplicity and effectiveness but, needle visibility remains a~     challenge because of the angle between the ultrasound beam and the needle.~      The retroclavicular approach for brachial plexus anesthesia requires an angle between the~     needle and the ultrasound beam that is less steep than the angle required to perform an~     infraclavicular coracoid block. This approach has already been proven effective and safe in~     the past.~      The general objective is to provide a formal comparison between the retroclavicular approach~     and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will~     delineate the differences between the two techniques.~   "
10971|NCT02913612|"~     Multi-center, double-masked randomized, efficacy, safety and pharmacokinetic (PK) study.~   "
10995|NCT02913261|"~     To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in~     patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem~     cell transplantation~   "
10961|NCT02913742|"~     Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant~     epilepsy in adults, and MRI-guided laser interstitial thermal therapy is a new approach to~     its surgical management; however, while LITT demonstrates fewer complications than~     traditional surgical techniques, it generates lower rates of seizure freedom. During~     traditional temporal lobectomy for MTLE, neurophysiologic intraoperative monitoring (NIOM)~     can be used to better identify epileptogenic tissue and guide resection. Our study proposes~     to investigate the utility of NIOM during LITT for MTLE. Subjects will be drawn from~     refractory mesial temporal lobe epilepsy patients determined to be candidates for LITT.~     During their LITT surgery, in addition to the placement of the stereotactic LITT probe,~     subjects will receive a second smaller stereotactic electrode for intraoperative monitoring~     of epileptic discharges before and after surgery. After surgery, at regularly scheduled~     follow-ups, patients will receive the Quality of Life in Epilepsy questionnaire~     (QOLIE-31-P), in addition to standard post-operative care. Endpoints will be surgical~     complications, fractional decrement in epileptiform discharges from pre- to post-ablation~     recordings, and surgical outcome at 6 months and one year. Analysis of severe complications~     will be expressed as a simple complication rate, for overall complications, severe~     complications, and hemorrhagic complications in specific. The relationship between~     fractional discharge decrement and outcome will be assessed by regression analysis. Risks of~     the study will stem from the placement of the stereotactic electrode for intraoperative~     monitoring, which represents a small incremental risk beyond typical LITT for MTLE.~   "
10962|NCT02913729|"~     Most of the local recurrences (LR) found after breast-conserving therapy are within or close~     to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving~     surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC~     boost trial, however, 29% of all LR were found outside the area of the original tumor.~     Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of~     local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere~     in the breast. This led to the concept of partial breast irradiation. With accelerated~     partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing~     for a higher dose per fraction compared to whole breast irradiation (WBI), which is~     favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per~     fraction.~   "
10963|NCT02913716|"~     This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and~     metabolite identification of defactinib.~   "
10964|NCT02913703|"~     Background and Significance: The peptide hormone ghrelin drives hunger and feeding behavior,~     making it a focus of obesity research. Released mainly by the stomach and proximal small~     intestine, ghrelin peaks prior to meals, potentially priming the gut for anticipated~     nutrients. After eating, ghrelin abruptly declines, with levels varying 2- to 3-fold between~     the fasted and fed states. Interestingly, in obesity and type 2 diabetes (T2D), this pattern~     is disrupted. Individuals with these disorders have chronically suppressed ghrelin levels~     and little variation before and after meals.~      Although ghrelin's preprandial rise and postprandial fall is a well-established phenomenon,~     its role in regulating glucose metabolism is unclear. In mice, increasing preprandial~     ghrelin levels improves glucose tolerance through enhanced glucagon-like peptide-1 (GLP-1)~     secretion. Ghrelin also stimulates GLP-1 secretion from mouse and human intestinal L-cells~     in vitro. These findings suggest enhanced postprandial GLP-1 as a novel role for the~     preprandial ghrelin surge. A ghrelin-incretin enteroendocrine axis could also explain the~     poor postprandial GLP-1 secretion and glucose tolerance in subjects with T2D, given their~     preprandial hypoghrelinemia.~      The investigators' preliminary data demonstrate that in humans, increasing circulating~     ghrelin to a supraphysiologic range worsened glucose tolerance, despite increased GLP-1~     secretion. The discrepancy between these findings and the ones from rodents could be due to~     difference in study design and/or species. For example, the investigators' study used a~     continuous ghrelin infusion, which resulted in elevated levels of ghrelin pre- and~     postprandially. Elevated postprandial ghrelin likely mitigated the positive effects of~     increased GLP-1 secretion by raising levels of glucagon and other counter-regulatory~     hormones.~      This study seeks to delineate the interactions between ghrelin and GLP-1 in the regulation~     of glucose tolerance, beta-cell function, and insulin sensitivity. The investigators~     hypothesize that increased preprandial ghrelin will enhance GLP-1 secretion and consequently~     improve glucose tolerance in healthy subjects and those with T2D. Confirmation of these~     hypotheses would advance the investigators understanding of the control of glucose~     homeostasis and have important clinical and therapeutic implications. Modulating ghrelin~     levels may provide a novel therapeutic strategy to improve glucose tolerance in individuals~     with T2D, which affects an estimated 350 million people worldwide.~   "
10965|NCT02913690|"~     This study aims to determine if tocotrienol rich fraction (TRF) supplementation can improve~     markers of inflammation, oxidative stress and blood lipids in Malaysian hemodialysis (HD)~     patients.~   "
10966|NCT02913677|"~     Recent studies showed the benefits of early initiation and advancement enteral feeds with~     daily increments in preterm infants on decreasing invasive infections and early achievement~     of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants~     are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of~     developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and~     the rate of increments of enteral feeds are usually uncertain issues for neonatologists.~   "
10967|NCT02913664|"~     Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's~     disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with~     lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects~     of aerobic exercise training and intensive vascular risk reduction on cognitive performance~     in older adults who have high risk for AD.~   "
10968|NCT02913651|"~     Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy~     affecting the sympathetic function. In this study the investigators analyzed whether altered~     diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free~     patients diagnosed with idiopathic hypersomnia and age-matched controls were included.~     Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to~     spontaneous arousal are analyzed.~   "
10969|NCT02913638|"~     The purpose of this clinical study which is to evaluate the benefits of lactation support~     intervention, in conjunction with maternal nutritional supplementation during the last~     trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast~     feeding practices (primary objective), and 2) cognitive development in children within 28~     months 16 days - 32 months 30 days (secondary objective).~   "
10972|NCT02913573|"~     Patients undergoing total mastectomy with immediate breast reconstruction with a tissue~     expander or implant under general anesthesia will be randomly assigned to the addition of a~     pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will~     be assessed.~   "
10973|NCT02913547|"~     The objective of the study is to evaluate the safety, efficacy and usage compliance of the~     home-use device Silk'n HST for self-treatment of periorbital wrinkles and skin laxity and~     improvement of skin appearance.~   "
10979|NCT02913469|"~     Percutaneous coronary intervention(PCI) has become the first choice for STEMI~     patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor~     inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief~     in necessity play a pivotal role in the treatment of patients with ST elevation myocardial~     infarction before primary percutaneous coronary intervention.And ticagrelor is recommended~     in patients with ST segment elevation myocardial infarction undergoing PCI, with class IB~     indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently,~     some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it~     is not clear of the pathogenesis of it.Some researchers say that morphine results in a~     weaker and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by~     inhibition of gastrointestinal peristalsis and causing vomiting.The study is aimed at~     exploring whether morphine delay and attenuate exposure to ticagrelor and its antiplatelet~     effect.In addition, the trial will explore the possible mechanism which morphne delay and~     attenuate exposure to ticagrelor in patients with ST-segment elevation myocardial infarction~     before PCI.~   "
10980|NCT02913456|"~     This disease registry is a prospective, multicenter non-interventional study designed to~     observe anti-cancer treatment regimens and clinical outcomes in participants with~     HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months~     old prior to registry enrollment.~   "
10981|NCT02913443|"~     This is a Phase I, open-label, multicenter study designed to assess the safety and~     tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and~     expansion study plans to determine the maximum tolerated dose and/or optimal biological dose~     as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability,~     pharmacokinetic and pharmacodynamic profiles observed after oral administration of~     RO7051790.~   "
10982|NCT02913430|"~     To study progression free survival for treatment with Fulvestrant compared to treatment with~     tamoxifen in Metastatic Breast Cancer.~   "
10983|NCT02913417|"~     Reports to date show limited efficacy of immunotherapy for uveal melanoma. Recent~     experimental and clinical evidence suggests synergy between radiation therapy and~     immunotherapy. The investigators will explore this synergy with a feasibility study of 18~     patients with uveal melanoma and hepatic metastases who will receive SirSpheres Yttrium-90~     selective internal hepatic radiation followed by immunotherapy with the combination of~     ipilimumab and nivolumab.~   "
10984|NCT02913404|"~     The purpose of this study is to asses functional biomechanical outcomes and patient reported~     outcome measures following single bundle ACL reconstruction (ACL-R) compared to single~     bundle ACL reconstruction and extra articular tenodesis (ACL-R+EAT).~   "
10985|NCT02913391|"~     Heart surgery can evolve with complications in the postoperative phase, mainly of a~     respiratory nature, atelectasis and hypoxemia being the main pulmonary dysfunctions. They~     can lead to increased length of hospitalization, being the major cause of morbidity and~     mortality in the postoperative phase of heart surgery. In order to prevent or reduce such~     complications noninvasive ventilation (NIV) has been used in the postoperative period in a~     prophylactic and therapeutic manner. The use of positive end expiratory pressure (PEEP) is~     already widely spread in intensive Care Unit (ICU), being used in patients under mechanical~     ventilation (MV), NIV and exercises with intermittent positive pressure and has huge~     scientific publication reporting its benefits for the pulmonary function. The alveolar~     recruitment maneuver (ARM) consists of sustained increase of pressure in the airway using~     PEEP in individuals with hypoxemia, in order to minimize the deleterious effects arising~     from alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma~     increasing the pulmonary area available for gas exchange and, consequently, arterial~     oxygenation. In recent years the increase in the application of PEEP in cardiopathic~     patients under MV has shown great benefits and the use of NIV to improve oxygenation by the~     reversal of atelectasis is already widely used and recommended in hospital routine. Despite~     NIV being used in great proportion, the relevant literature is poor in showing studies with~     NIV and ARM associated in heart surgery. Therefore, the objectives of this study are to~     evaluate if the use of NIV associated with ARM improves oxygenation in patients in~     postoperative revascularization of the myocardium related to usual use without ARM, and if~     it can be applied in a safe manner.~   "
10986|NCT02913378|"~     This is a randomized trial comparing conservative with surgical treatment (with open~     reduction and locking plate fixation) for proximal humeral fractures in patients aged more~     than 60 years.~   "
10987|NCT02913365|"~     The study consist of a retrospective analysis of the etiologies, investigations and outcomes~     of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary~     center.~   "
10988|NCT02913352|"~     Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette~     (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral~     dislocation.~   "
10989|NCT02913339|"~     Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths.~     Despite the availability of management and treatment for CVD which is offered to the~     uninsured population at government primary care clinics (PCCs), the rates at which those at~     risk are screened, identified and referred to the clinics are very low. This study will~     determine if providing CHWs with an mHealth application using an integrated, inexpensive and~     validated screening tool on cell phones for screening in the community which is linked with~     the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they~     identify high-risk individuals, will increase the number of referral and follow-up visits~     that patients attend at the PCCs.~   "
10990|NCT02913326|"~     This is a multi-center, prospective, international, randomized (1:1), open-label study with~     two parallel groups. This phase III study is planned to investigate the efficacy and safety~     of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of~     major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with~     blinded endpoint adjudication.~   "
10991|NCT02913313|"~     A study to evaluate the Safety and Tolerability of Monoclonal Antibody BMS-986207 alone and~     in Combination with Nivolumab in Advanced (Solid Tumor) Cancers~   "
11020|NCT02912936|"~     The purpose of this study is to determine safety, tolerability, and~     pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain~     triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory~     biomarkers in response to this intervention will also be explored.~   "
10997|NCT02913235|"~     The purpose of the present investigation is to record and compare bacterial compositions in~     supragingival plaque samples and saliva samples in subjects discontinuing regular oral~     hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might~     reflect local bacterial alterations in relation to discontinuation of oral hygiene.~   "
10998|NCT02913222|"~     Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in~     young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of~     PAHD is needed to improve function in the young adult and prevent or delay the onset of hip~     OA, however evidence related to treatment of PAHD is limited. This research will provide the~     foundation for a future clinical trial to assess the efficacy of movement pattern training,~     an innovative rehabilitation approach for the treatment of PAHD.~   "
10999|NCT02913209|"~     Fatigue is consistently rated as the top symptomatic complaint for individuals with multiple~     sclerosis (MS). Currently, the MS Fatigue Impact Scale (MFIS), a subsection of the Multiple~     Sclerosis Quality of Life (MSQoL), is the clinical standard used by neurologists for~     monitoring and tracking fatigue in individuals with MS. However, fatigue is multidimensional~     phenomenon and subjective measures have had poor or limited relationships with functional~     status. While previous study has focused on contributing factors to fatigue such as sleep~     disorders and diminished cortical excitability, this line of inquiry has neglected the role~     of muscle structure and function on fatigue in every day functional tasks. An alternative~     approach is to assess quantitative fatigue using anaerobic testing methods. However, more~     knowledge is needed to understand the role that quantitative fatigue plays in self-reported~     fatigue measures and function of daily activities. Our purpose is to determine the~     association between quantitative fatigue tests with performance-based measures of mobility~     and self-reported health-related quality of life. Our secondary goal is to understand how~     the intrinsic properties of muscle tissue influence muscle performance in Veterans with MS.~   "
11000|NCT02913196|"~     This is a multi-center, Phase I study of apalutamide in combination with abiraterone~     acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate~     cancer (mCRPC).~      This study is designed to determine the dose that apalutamide can be administered safely in~     combination with abiraterone acetate, docetaxel and prednisone.~   "
11001|NCT02913183|"~     Stroke is one of the main severe disease of public health importance. Recent studies showed~     that old age is one of the most important factors in influencing the outcome of patients~     with acute stroke, and the young plasma can reverse age-related brain impairments in mice.~     Therefore, this pilot study aims to investigate whether young plasma is effective in~     alleviating brain injury and neurologic deficits induced by acute stroke in patients.~   "
11002|NCT02913170|"~     The aim of this study is to examine the effects of nattokinase supplementation on hemostatic~     factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time,~     prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid~     profiles were measured at baseline and at 8-week follow-up.~   "
11003|NCT02913157|"~     The purpose of this clinical trial is to determine if HCQ in a dose of 400mg daily can~     prevent worsening of walking ability in people PPMS. The number of participants in this~     study will be 35. A maximum of 42 people with PPMS will be included. The trial is funded~     through a private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials~     Research Program and the University of Calgary. There is no sponsorship from the~     pharmaceutical industry.~   "
11004|NCT02913144|"~     OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of~     coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and~     the relation to traditional as well as new cardiovascular risk factors.~      METHODS: The Danrisk cohort was established in 2009-2010 based on random retrieval from the~     Danish national civil registry (N=1825). Initially, distribution of gender, area of~     residence and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH,~     Svendborg, Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to~     undergo cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for~     CAC estimation, and a total of 1227 subjects were found free of cardiovascular disease (CVD)~     and diabetes (DM), and was included in the study back then.~      In 2014-2015 the DanRisk cohort was invited to a 5 year follow-up examination. The~     investigators examined a total of 1031 subjects (82%) in the investigators 4 regional~     centres. The follow-up examination included general health evaluation and estimation of CAC~     by non-contrast enhanced cardiac CT-scan. Information of death, cardiovascular events and~     medication usage was obtained from the Danish national patient register, the Danish register~     of causes of death and the Danish national database of reimbursed prescriptions in 2016.~   "
11005|NCT02913131|"~     This is a single center prospective imaging study investigating the utility of~     hyperpolarized C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with~     advanced solid tumor malignancies. The current protocol will serve as a companion imaging~     biomarker study paired with therapeutic trials of PI3K/mTOR pathway inhibitors (e.g.~     CUDC-907, BYL719), as well as a stand-alone protocol for patients treated with~     standard-of-care therapies inhibiting the PI3K/mTOR signaling pathway (eg. everolimus).~   "
11006|NCT02913118|"~     Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A~     Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is~     that combination therapy with Andrographolid Sulfonatein injection and antibacterial is~     significantly better than antibacterial alone in achieving clinical stability among~     hospitalized CAP patients.~   "
11007|NCT02913105|"~     The purpose of the present study is to assess the effects of LMB763 with respect to safety,~     tolerability, and on markers of liver inflammation in patients with NASH~   "
11008|NCT02913092|"~     This study will evaluate the role of using electronic sensors for asthma inhaler devices in~     monitoring medication adherence and asthma control~   "
11021|NCT02912923|"~     The project targets stroke survivors to investigate the effect of augmented feedback (using~     robotic force cues and visual feedback) and rewards (game scores), on their upper limb~     reaching patterns and trunk compensatory movements~   "
11022|NCT02912910|"~     To study central blood pressure changes caused by commonly used high blood pressure~     medications in pregnancy.~   "
11009|NCT02913079|"~     Context and Rationale: Uninterrupted sitting is associated with increased risk of diabetes,~     heart disease, and death, even among people who are physically active. These relationships~     are likely due to increases in post-meal blood sugar observed when people sit for long~     periods (e.g. > 1 hour) without interruption. In contrast to sitting, standing results in~     large reductions in post-meal blood sugar levels. Our group has recently shown that~     sit-stand desks result in large (e.g. 2.5 hour/day) reductions in occupational sitting time.~     Taken together, these findings suggest that sit-stand desks may help to reduce post-meal~     blood sugar levels. However, this has yet to be examined in the field. Theoretical Approach~     and Objectives: The objective of this randomized crossover study is to determine whether~     people have lower blood sugar when using a sit-stand desk, in comparison to a desk that can~     only be used while sitting. Methods and Procedures: Sixteen participants will be asked to~     wear a continuous glucose monitor to measure their blood sugar levels during 2 separate~     conditions. During one condition, they will be asked to use a sit-stand desk to sit and/or~     stand as much as they like during 1 workday. During the other condition, they will be asked~     to work at a seated desk for 1 workday. Participants will be provided with identical meals~     to eat during each of the two conditions. We hypothesize that participants will have lower~     blood sugar levels on the day when they use the sit-stand desk, in comparison to the day~     using a traditional seated desk. Significance and Future Use: If our results support this~     hypothesis, this would suggest that sit-stand desks may be a useful way to reduce blood~     sugar levels in people at risk for diabetes. This could also lead to larger population-based~     interventions studying the health impact of sit-stand desks.~   "
11010|NCT02913066|"~     Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma,~     divided into 2 groups randomly:~      Experimental group: radiotherapy combined with S-1 chemotherapy.~      Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.~   "
11011|NCT02913053|"~     Exercise interventions to prevent dementia and delay cognitive decline have gained~     considerable attention in recent years. Human and animal studies have demonstrated that~     regular physical activity targets brain function by increasing cognitive reserve. Although~     initial studies indicate enhanced cognitive performance in patients with mild cognitive~     impairment (MCI) following an exercise intervention, little is known about the effect of an~     extensive, controlled and regular exercise regimen on the neuropathology of patients with~     MCI.~      The aim of this study is to compare a 12- month aerobic exercise programme versus a~     stretching and toning (non-aerobic) programme versus a control group on the progression of~     cognitive decline in MCI.~      It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will~     show less progression or even be improved after a one-year aerobic exercise intervention~     compared to a group of patients undergoing stretching and toning exercise as well as to a~     control group provided with no intervention.~   "
11012|NCT02913040|"~     In this multi-centre randomized controlled trial the investigators compare the effect on~     dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal~     Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe~     dyspnoea.~   "
11013|NCT02913027|"~     The purpose of this study is to investigate patients self-reported comfort levels during~     each section of the pelvic exam.~   "
11014|NCT02913014|"~     This study is being done to find out if patients taking Anti Arrhythmia Drugs (AAD's) after~     cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti-~     Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study~     will also look at the side effects of the AAD's.~   "
11015|NCT02913001|"~     This randomized controlled trial will examine changes in some hormonal markers associated~     with acne among adults with moderate/severe acne randomized to a low glycemic index and~     glycemic load diet or usual eating plan for two weeks.~   "
11016|NCT02912988|"~     In-vitro fertilization (IVF) is the treatment of choice for couples with prolonged~     infertility. The treatment usually involves hormonal stimulation of the ovaries by follicle~     stimulating hormone (FSH), followed by surgical removal of eggs which are then mixed with~     sperm in the laboratory to create embryos. The success rates of IVF treatment remain~     unsatisfactory and are no longer increasing. One of the reasons is an adverse effect of high~     serum estradiol levels following FSH stimulation on the lining of the uterus.~      Letrozole is a drug used in the prevention of recurrence of breast cancer because of its~     action to reduce the intra-ovarian aromatization of androgens to estrogens. It is now~     increasingly used for ovulation induction and is as safe as clomiphene citrate. Use of~     letrozole during standard ovarian stimulation for IVF producing adequate numbers of oocytes~     with physiological levels of estradiol may increase the present success rate of standard IVF~     treatment.~      The aim of this randomized study is to compare the live birth rate of FSH alone versus~     combined FSH and letrozole used for ovarian stimulation in IVF treatment.~   "
11017|NCT02912975|"~     A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and~     residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study~     will be conducted with a semi-crossover design using self-rated pain and function as the~     main result variables.~   "
11018|NCT02912962|"~     Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and~     behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with~     FASD often struggle with self-regulation, or the ability to control thoughts, emotions and~     actions, which can lead to many long-term problematic life circumstances.~      This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD~     using a targeted intervention. Researchers adapted the Alert Program®, a developed~     intervention targeting self-regulation in children, to be appropriate for an adolescent FASD~     population. Participants are split into two groups: an FASD intervention group, and an FASD~     waitlist group. These groups are compared on a variety of measures. These measures include~     cognitive measures (executive functioning, response conflict, inhibitory control, etc),~     behavioural measures (self-regulation, adaptive behaviour, etc), and physiological measures~     (cortisol and sleep). The FASD intervention group will be tested at baseline and once after~     the intervention, and lastly after an approximately 12-week wait following the intervention.~     The FASD waitlist group will be tested at baseline, after a three month wait period, and~     again after receiving the intervention.~      The investigators expect that the Alert program® will lead to significant improvements in~     participant's self-regulation abilities as evidenced by cognitive, behavioural, and~     physiological changes. Improving self-regulation in adolescents with FASD will reduce the~     high level of adverse outcomes experienced by adolescents with FASD, and help them have a~     successful transition into adulthood.~   "
11019|NCT02912949|"~     This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single~     group assignment study to assess the safety, tolerability, PK, PD, immunogenicity and~     anti-tumor activity of MCLA-128~   "
35527|NCT02591953|"~     Using randomization, prospectively determine superiority of either ultrasound-guided or~     landmark-guided biceps corticosteroid injections with regard to various clinical variables.~   "
11023|NCT02912897|"~     The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood.~     Indeed MS is a multifactorial disease involving genetic and environmental factors and~     Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV~     infection and the immunological mechanisms underlying MS is not clear. Robust~     sero-epidemiological evidences support an association between EBV infection and MS, and~     immunological data suggest an altered/deficient immune response against this virus. In~     healthy individuals EBV produces a persistent infection that is tightly controlled by the~     immune system. In patients with MS, cellular and humoral immune studies demonstrate an~     altered response against the virus with a T-cell abnormal reactivity against the~     EBV-infected autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear~     Antigen-1, and in the case of children, an increased EBV shedding, demonstrating frequent~     EBV reactivations. Thus, it has been proposed, that patients with MS present a partially~     inefficient control of the EBV infection. Some experimental data support the hypothesis~     suggesting that the presence of autoreactive EBV-B cells in the meninges of patients,~     probably due to an insufficient clearance of these cells by the immune system, lead to the~     infiltration of autoreactive T cells. Another hypothesis also suggests a deficient control~     of the virus, in that case during the inactive phase of the disease. Together, the above~     data and hypotheses lead to the notion that an immune intervention capable of restoring the~     host-EBV balance could be beneficial to MS patients In this project, we will assess the~     feasibility and safety of autologous transfer of several amounts of CD8 T cells directed~     against autologous EBV transformed B cell lines, in order to finally restore an efficient~     control of EBV in MS patients. The main objective of the project is to test the feasibility~     and safety of the process, while efficacy parameters will be also assessed in secondary~     objectives.~   "
11024|NCT02912884|"~     Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential~     Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of~     both venous and arterial thrombosis. Thrombotic complications are the main determinant of~     morbidity and in a less extend mortality.~      Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a~     hypercoagulable state. However, previous evidence suggests that global coagulation tests~     such as thrombin generation or thromboelastometry are able to detect signs of procoagulant~     imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties~     (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an~     hypercoagulable state.~      Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic~     events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed~     for PV and are under investigations on clinical trial for ET. It is currently unknown if~     treatments that were used for ET and PV, and especially JAKi are able to modify the~     hypercoagulable state that is observed in those diseases, and if there is difference between~     drugs.~      To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to~     evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.~   "
11025|NCT02912871|"~     Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as~     safe and as effective as any of the surgical treatments within the currently accepted~     standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A~     unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor~     symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided~     High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several~     potential advantages over current therapies including the fact that transcranial lesioning~     can be performed in a precise manner with simultaneous as well as continuous clinical and~     radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be~     realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable~     alternative procedure for subjects considering DBS.~   "
11026|NCT02912858|"~     Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant~     burden on the patient, their family, and healthcare resources. Treating VLU can present a~     significant challenge to clinicians, who currently have a limited range of treatments at~     their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation~     at rest. In addition to the aforementioned, intermittent pneumatic compression has also been~     utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices~     intermittently inflate and deflate to increase venous return. These devices can be~     uncomfortable to wear, and compliance can be inhibited because of size, weight and external~     power source that limit the patient's mobility. In patients who cannot walk, or in those who~     are unable to tolerate compression bandaging, ulcers may deteriorate and never heal.~     Accordingly, there is a need for novel, alternative devices or strategies that can be used~     to complement or replace compression bandage therapy.~   "
11027|NCT02912845|"~     The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies~     Immunoglobulin) in children ages 0 months to <17 years, when administered as part of~     post-Rabies Exposure Prophylaxis (PEP).~   "
11028|NCT02912832|"~     The purpose of this study will be to determine the performance characteristics of TBDx with~     culture as a gold standard. In addition, the investigators will assess the laboratory~     technicians' appraisal and technical suitability of the TBDx system.~   "
11029|NCT02912819|"~     General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The~     open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry~     hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse~     during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening~     and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized~     patients.~      Investigators hypothesized that the SpO2 breathing air can personalize the open-lung~     approach.~   "
11030|NCT02912806|"~     Evolving reimbursement policies are driving health systems to improve quality and~     efficiency. Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock~     Medical Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee~     Replacement (TKR). The organization implemented a coordinated team-based care delivery model~     that integrated real-time measurement of: (1) compliance with trusted guidelines, (2)~     process of Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs).~     The investigators present the implementation protocol and data.~   "
11050|NCT02912546|"~     Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral~     perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt~     position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in~     hypertensive patients and during stroke, varying degrees a various loss of cerebral~     autoregulation is loss are usually observed. The aim of this study is to assess cerebral~     perfusion with ASL perfusion in human subjects in different conditions: healthy,~     hypertensive and stroke.~   "
11051|NCT02912533|"~     The purpose of this study is to investigate the safety and efficacy for 52-week dosing of~     JR-131 in renal anemia patients with chronic kidney disease (CKD).~   "
11031|NCT02912793|"~     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental~     treatment for people with Niemann-Pick disease Type C1 (NPC-1) is safe at 3 different dose~     levels and what effects it has on people who have this condition. NPC-1 is caused by a~     defect in a protein which is important for the transport of fatty substances like~     cholesterol out of cells. Without this protein, fats build up in the cells ultimately~     leading to organ damage. The way in which this experimental treatment works is not fully~     understood but laboratory experiments have shown that it can potentially remove cholesterol~     build up from the cells in people who have NPC-1. Approximately 12 patients will be asked to~     take part in this research study for up to 56 weeks in total. recruitment is expected to~     take 9 months.Patients who take part will receive treatment by an intravenous infusion every~     two weeks. The study will look at what the body does to the drug as well as what the drug~     does to the body by taking and examining blood and urine samples. Samples of Cerebrospinal~     fluid (CSF) are also taken by lumbar puncture during and following the first treatment dose.~     Patients will also have their hearing tested, be asked questions by their doctor as well~     completing questionnaires to help assess any changes in their condition during treatment.~     Optional assessments patients can choose to take part in include liver biopsies, additional~     lumbar punctures for CSF.examinations to see if the drug is affecting these. This study is~     being sponsored and funded by CTD holdings INC. It is planned to be run in the UK, Italy,~     and Sweden.~   "
11032|NCT02912780|"~     The advancement in life-saving technologies and clinical expertise in the care of extremely~     premature infants, have resulted in the development of large neonatal intensive care units~     (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to~     smaller care units with specific patient population and clinical team providers will be~     essential to maintain optimal teamwork, quality of care and patient outcome.~      Despite the growing knowledge around the need for reconstruction of large NICUs to smaller~     units of care, there is no evidence regarding the safety and efficacy of microsystem model~     of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we~     planned a change from standard model of care to the microsystem model of care and therefore~     we aimed to prospectively assess the effect of this organizational change on the variable~     aspects of health care.~      A working group met weekly to formulate the implementation planning, to review the~     adaptation and adjustment process and to ascertain the quality of implementation following~     the initiation of the microsystem model.~      The study was retrospectively registered.~   "
11033|NCT02912767|"~     The investigators are interested in understanding how the patient has been doing since their~     surgery for endometrial cancer and if they are experiencing any symptoms related to~     lymphedema (swelling) in the your lower body. The investigators hope that information from~     the patient and others will help them improve care for women treated for endometrial cancer.~   "
11034|NCT02912754|"~     This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic~     Lymphocytic Leukemia (CLL).~   "
11035|NCT02912741|"~     The aim of this study is to evaluate the addition of new technology of resin modified~     glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot~     lesions; both applies into the same patient's mouth; to reveal which material will have more~     clinical satisfactory performance inside the oral cavity and to overcome the high expensive~     cost in treating such clinical cases~   "
11036|NCT02912728|"~     The primary objective of this study is to compare the efficacy and safety of CGM alone and~     CGM combined with a family behavioral intervention with a control group using home blood~     glucose monitoring (BGM) alone.~   "
11037|NCT02912715|"~     Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1,~     6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented~     re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery~     (PPA) in a Chinese patient population.~   "
11038|NCT02912702|"~     This study aimed to investigate the efficacy and safety of Pegaspargase together with~     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial~     treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.~   "
11039|NCT02912689|"~     Number of Patients:~      Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) =~     20~      Inclusion criteria~      a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory~     failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no~     indication for invasive mechanical ventilation.~      Exclusion criteria~        1. Patient with any contra-indication for insertion of nasogastric tube (like recent~          gastrointestinal bleeding in previous 30 days, esophageal varices)~        2. Patient with any contraindication of noninvasive ventilation (such as hemodynamic~          instability, active gastrointestinal bleed etc)~        3. Patients with a known neuromuscular, central or peripheral nervous system disorder.~        4. Patient not willing to give consent.~      Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control~      Study design: Randomized interventional study~      Dosages of drug: None~      Duration of treatment: Till patient improves or requires invasive ventilation.~      Brief Methodology Patients of COPD with acute exacerbation will be randomized into two~     groups (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special~     naso-gastric catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will~     be applied using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks.~     Patients in Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA.~     Pressure support and PEEP levels will be set by the treating physician to achieve a tidal~     volume (Vt) of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak~     pressures of NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min~     period of each NIV trial will be recorded and manually analyzed offline. Subsequent readings~     will be taken at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In~     each trial, patient-ventilator asynchronies (ineffective efforts, auto triggering, premature~     cycling, delayed cycling, and double triggering) will be determined on EAdi, airway~     pressure, and flow signal. The number of each type of asynchrony, defined as the number of~     events per minute, will be determined for each recording period. The asynchrony index (AI),~     in percentage, will be calculated as described previously, and an AI >10% will be considered~     severe asynchrony. Patient comfort level after each mode of ventilation will be assessed by~     using visual analogue scale. Various clinical, ventilatory and arterial blood gas parameters~     will be recorded.~      Statistical analysis Data will be expressed as mean ± standard deviation (SD), or~     percentage. Differences in continuous variables between the two groups will be compared~     using student's t test (or Mann-Whitney U test); while differences in categorical data will~     be compared using the chi- square test (or Fisher's exact test). A p value of less than 0.05~     will be considered statistically significant.~   "
11040|NCT02912676|"~     Acute Lymphoblastic Leukaemia (ALL) is the most frequent cancer in children. The survival~     rate has improved significantly during the last decades, but the treatment still fails to~     cure 15 % of the patients. Within the Nordic/Baltic countries, children are treated~     according to the same protocol, i.e. NOPHO ALL-2008 protocol. The longest treatment phase is~     maintenance therapy, which is composed of 6-Mercaptopurine (6MP) and Methotrexate (MTX).~      The cytotoxic property of 6MP relies upon conversion of 6MP into thioguanine nucleotides~     (TGN), which can be incorporated into DNA instead of guanine or adenine. This incorporation~     can cause nuclotide mismathing and cause cell death second to repetitive activation of the~     mismatch repair system. At Rigshospitalet the investigators have developed pharmacological~     methods able to measure the incorporation of TGN into DNA (DNA-TGN). In a Nordic/Baltic~     study the investigators have demonstrated higher levels of DNA-TGN during maintenance~     therapy in participants that do not develop relapse.~      Preliminary studies indicate that the best approach to obtain DNA-TGN within a target range~     could be a combination of 6MP, MTX and 6-thioguanine (6TG), as 6TG more readily can be~     converted into TGN.~      This study aims to explore if individual dose titration of 6TG added to 6MP/MTX therapy can~     achieve DNA-TGN levels above a set target above 500 fmol/µg DNA, and thus can be integrated~     into future ALL treatment strategies to reduce relapse rates in ALL.~      The investigators plan to include 30 patients, and A) give incremental doses of 6TG until~     DNA-TGN above 500 fmol/µg DNA is obtained; and B) analyze the changes in DNA-TGN as well as~     cytosol levels of TGN, methylated 6MP metabolites, and MTX polyglutamates (the latter two~     metabolites inhibit purine de novo synthesis and thus enhance DNA-TGN incorporation), and C)~     occurrence of bone-marrow and liver toxicities during 6TG/6MP/MTX therapy.~   "
11041|NCT02912663|"~     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the~     safety and feasibility of super-selective intra-arterial administration of verapamil and~     magnesium sulfate immediately following successful endovascular thrombectomy as a potential~     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.~     This trial represents the first time that magnesium sulfate will be evaluated in human~     subjects as a superselectively administered neuroprotective agent administered in an acute~     time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the~     first trial to evaluate combinational therapy for acute stroke neuroprotection.~   "
11052|NCT02912520|"~     Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota~     of the gut. Investigators will compare microbiota-dependent Ig production in the~     bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to~     detect significant differences.~   "
11042|NCT02912650|"~     This is a randomized, double blind, placebo-controlled, parallel group, single-center study~     in approximately 560 subjects to determine the overall analgesic efficacy and safety of a~     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg~     alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and~     females aged 18-40 years, inclusive, who are experiencing post-operative pain following~     surgical extraction of 3 or more third molar teeth. Following extraction, subjects must~     experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point~     categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at~     least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a~     single oral dose of study medication under double-blind conditions and then evaluated on~     site for 12 hours following administration of study medication. Subjects will provide~     self-ratings of pain severity and pain relief at various time points using categorical and~     numerical scales. Additionally, subjects will also evaluate the time to first perceptible~     relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours,~     subjects will complete a categorical Global Evaluation of the study medication. A review of~     any reported adverse events will also be completed.~   "
11043|NCT02912637|"~     Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to~     severe breathing problems and/or respiratory failure. Imaging is central to guiding~     treatment; however, current techniques are either inaccurate or involve exposure to~     radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a~     radiation-free alternative. However, conventional MRI cannot directly show changes in~     distribution of inhaled air or absorption of gas which are important signs of early lung~     disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed~     which can provide this important information. This study aims to determine how Xenon MRI can~     help determine air flow distribution and gas uptake in the lungs. The investigators will~     also be able to compare the information from patients with that from healthy volunteers.~     This should give insight into the processes involved in chronic lung diseases and help~     evaluate disease extent in patients.~   "
11044|NCT02912624|"~     Circulatory shock is a condition of generalized inadequate blood flow through the body,~     leading to insufficient tissue perfusion and inadequate delivery of oxygen and other~     nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory~     failure are distinguished, caused by a scale of underlying illnesses: distributive,~     hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a~     low cardiac output and hypovolemia. Distributive shock is characterized by peripheral~     circulation failure, with a low systemic vascular resistance, a disturbed microcirculation~     and a high cardiac output. Frequently, these forms overlap.~      Shock is a common problem in the intensive care unit (ICU) as it affects about one third of~     the patients. Septic shock appears to be the most common type, followed by cardiogenic and~     hypovolemic shock. The diagnosis of shock is based on clinical examination with use of~     well-known circulatory parameters such as blood pressure and heart rate; biochemical~     parameters such as lactate and direct (semi-)invasive measurement of cardiac output and~     other variables.~      Since cardiac output is an important determinant of oxygen delivery, many different methods~     of measuring cardiac output have been suggested. These methods range from non-invasive to~     invasive measurements with central lining. The most invasive method, the pulmonary artery~     catheter (PAC) has long been considered the optimal form of monitoring cardiac output by~     using thermodilution. However, this technique is associated with adverse events, such as~     bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other~     techniques have been proposed, ranging from systems that use the dilution technique but only~     require central venous and peripheral artery lines; to less invasive tools that estimate~     cardiac output based on the arterial pressure waveform; and to non-invasive~     echocardiography.~      Despite technical advances, much remains unknown about the value of conventionally used~     hemodynamic parameters for estimating cardiac output. A distinction between macro- and~     microcirculatory parameters can be made. Commonly used macro-circulatory parameters are~     heart rate, systolic and diastolic blood pressure, mean arterial pressure and central venous~     pressure. Lactate is used as a proxy for microcirculatory status. Over the years several~     other measurements have been suggested to improve insight in the hemodynamics of a certain~     patient or a group of patients. Skin temperature, capillary refill, mottling score and~     urinary output are used for hemodynamic assessment of the peripheral circulation and tissue~     perfusion. Most of these parameters have not been evaluated in a large prospective study and~     especially a combination of all these parameters has not directly been correlated to cardiac~     output.~      More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac~     output could assist physicians in earlier detection of impaired hemodynamics without the~     need for invasive or advanced methods. In this study the investigators aim to evaluate all~     hemodynamic parameters in a large unselected population of critically ill patients and to~     correlate them to cardiac output.~      Purpose:~      The purpose of this study is to create an infrastructure for a registry flexible to~     incorporate temporarily added specific research questions on the outcome of critically ill~     patients.~   "
11045|NCT02912611|"~     This feasibility study will be conducted at 4 international sites located in Asia (Dhahran,~     Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba,~     Bolivia).~      Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1~     regional referral hospital) that service the population around the site area. Patients~     presenting at a health care clinic or hospital emergency department with signs and symptoms~     associated with high and moderate risk of developing AKI will undergo a point of care (POC)~     test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and~     a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who~     meet the study inclusion criteria will be approached for consent. Patients enrolled in the~     study will be followed throughout the health care evaluation and tracked through their~     course by location i.e. health care center, hospital, and home. Outcomes will be recorded~     through 6 months following the health care evaluation.~      The protocol will have an initial observation phase, during which relevant healthcare staff~     and the research team will be trained to identify patients at moderate or high risk of AKI~     and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick~     (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked~     throughout the health care evaluation, however the teleconsultation will not be implemented~     and no specific guidance for managing the patient will be provided.~      During the subsequent intervention phase, the research team will interact with the local~     healthcare providers to and the teleconsultation physician, providing guidance on the~     management of the patient based on a standardized protocol. Protocols for patient care will~     be pre-specified, with minor adjustments to meet local requirements.~   "
11046|NCT02912598|"~     Surgery involving the chest cavity, particularly VATS procedures, often require one-lung~     ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation~     with different models of bronchial blockers (BB) used in special populations and~     circumstances. Their routine use is impeded by prolonged placement times, frequent~     malpositionings and higher costs when compared to the DLT, as recently reported in a~     meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a~     single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial~     placement without the use of a fiberoptic bronchoscope. An external monitor provides~     continuous visualization of the tracheal carina and the position of the bronchial cuff. The~     purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when~     compared to a left-sided double-lumen tube and established bronchial blockers. The~     investigators hypothesized a reduction in time to initial lung isolation due to the~     simplified placement procedure compared to other bronchial blockers. Continuous~     intraprocedural airway visualization may allow for early detection of dislocations.~     Necessary repositionings may be possible without additional bronchoscopies, reducing both~     disruptions of ventilation and maintenance costs.~   "
11047|NCT02912585|"~     Infections are the main causes of morbidity and mortality in very low birth weight infants.~     Use of mother's own breast milk in feeding these babies is associated with a decreased risk~     of acquiring nosocomial infection. This protective effect is assigned to a plurality of~     immune components in human milk. However, clinical instability of the preterm newborn in the~     first days of life results in delayed initiation of enteral nutrition. Thus, alternative~     methods for colostrum administration have been investigated, such as oropharyngeal~     administration with evidence that would be safe and feasible to perform in children admitted~     to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect~     of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth~     weight preterm infants.~   "
11048|NCT02912572|"~     This research study is evaluating a drug called Avelumab as a possible treatment for~     recurrent or Metastatic Endometrial Cancer.~   "
11049|NCT02912559|"~     This randomized phase III trial studies combination chemotherapy and atezolizumab to see how~     well it works compared with combination chemotherapy alone in treating patients with stage~     III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair or microsatellite~     instability. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin~     calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells~     to grow and spread. Giving combination chemotherapy with atezolizumab may work better than~     combination chemotherapy alone in treating patients with colon cancer.~   "
11053|NCT02912507|"~     Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten~     laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser~   "
11055|NCT02912481|"~     Arterial catheterization in small children is challenging, even for experienced~     anesthesiologists. For successful arterial catheterization, the arterial diameter,~     cross-sectional area, and depth from the skin surface are important considerations,~     especially in pediatric patients. THe investigators examined the posterior tibial artery~     (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative~     arterial cannulation site to the radial artery (RA) in pediatric patients.~   "
11056|NCT02912468|"~     Primary Objective:~      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone~     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and~     endoscopic nasal polyp score (NPS) in patients with bilateral nasal polyposis (NP). In~     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses~     will be also a co-primary objective.~      Secondary Objectives:~        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).~        -  To evaluate the efficacy of dupilumab in improving sense of smell.~        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses~          (Primary objective for Japan).~        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment~          with oral corticosteroids or NP surgery.~        -  To evaluate the effect of dupilumab on patient reported outcomes and health related~          quality of life outcome by sinonasal outcome test-22 (SNOT-22).~        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and~          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated~          respiratory disease [NERD]).~        -  To evaluate residual effect in follow up.~        -  To evaluate the safety of dupilumab in patients with bilateral NP.~        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of~          treatment-emergent anti-drug antibodies (ADA).~   "
11057|NCT02912455|"~     This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes~     post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy~     vs. placebo on clinical outcomes of type 2 diabetes.~   "
11058|NCT02912442|"~     The present Ph.D.-study investigates the mechanisms behind the association between thyroid~     autoimmunity and reproductive failure.~   "
11059|NCT02912429|"~     There is currently no sufficient evidence if there is superiority of one of the two~     available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is~     the aim of this study to compare the two types in a prospective comparative setting.~     Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay~     or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary~     outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella~     score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration,~     revision surgery and parameters of patellofemoral tracking. Inferential statistics will be~     performed at 1-year follow up data-sets.~   "
11060|NCT02912416|"~     Determine the effect of probiotics on improving iron status in a population of healthy,~     pregnant women.~   "
11061|NCT02912403|"~     Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period.~     Investigators will use a home blood pressure monitor that stays on the arm, and takes blood~     pressures hourly. Participants will record any symptoms that they feel are attributed to~     high blood pressure and pain medication use.~   "
11062|NCT02912390|"~     Through cervical length measurement in uncomplicated twin gestations, women with cervical~     length ≤ 25 mm will be approached for randomization to cerclage placement or expectant~     management with activity restriction and treatment of preterm labor~   "
11063|NCT02912377|"~     Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to~     assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim~     (B12019) and the reference product Neulasta® in healthy subjects~   "
11064|NCT02912364|"~     Double-blind, randomized, two period crossover comparison of the cognitive and behavioral~     effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.~   "
11065|NCT02912351|"~     This is a retrospective, single-site observational study, designed to assess the clinical~     outcomes and collect safety data of GMK Revision knee system used for primary or revision~     total knee arthroplasty at minimum two years post-treatment.~   "
11066|NCT02912338|"~     Purpose: To understand the change in body composition, physical functions and quality of~     life of elderly residents with sarcopenic obesity in LTC facilities after the implementation~     of exercise intervention.~   "
11067|NCT02912325|"~     The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in~     lowering serum lipids and glucose in subjects with Metabolic Syndrome;~      The secondary objectives of the trial are:~        -  to evaluate the potential benefit after 3 months of therapy (by an interim analysis)~        -  to evaluate the safety of FaseMETS~   "
11068|NCT02912312|"~     The goal of this clinical research study is to compare how often arm swelling develops after~     4 weeks of radiation treatment to how often arm swelling develops after 6 weeks of radiation~     treatment in patients who receive radiation therapy delivered to the lymph nodes near the~     breast. Researchers also want to know about other side effects that can develop during or~     after radiation treatment.~      The goal of this clinical research study is to compare how often arm swelling develops after~     4 weeks of radiation treatment to how often arm swelling develops after 6 weeks of radiation~     treatment in patients who receive radiation therapy delivered to the lymph nodes near the~     breast. Researchers also want to know about other side effects that can develop during or~     after radiation treatment.~   "
11069|NCT02912299|"~     This study investigates the differens in sodium storage in skin between normal subjects,~     patients after cardiac surgery and septic patients.~   "
11070|NCT02912286|"~     The aim of this study is to compare the postoperative pain after root canal treatment~     following irrigation by endodontic needle, sonic and passive ultrasonic irrigation~     techniques.~   "
11071|NCT02912273|"~     To establish the optimal strategy of fall-risk assessment to predict falls in older adults~     receiving cancer therapy.~   "
11072|NCT02912260|"~     The primary objective of this study is to determine the effect of once-daily oral MGL-3196~     on the percent change in hepatic fat fraction from baseline in patients with biopsy-proven~     Non-alcoholic Steatohepatitis (NASH).~   "
11073|NCT02912247|"~     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha~     monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in~     healthy volunteers.~   "
11074|NCT02912234|"~     This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose~     pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).~   "
11075|NCT02912221|"~     This study will examine the benefits of a monitored physical activity program for~     participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable~     activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an~     incentive is better than no incentive in maintaining an increased level of physical activity~     and 2) the benefits of physical activity on patient reported disease activity in~     inflammatory arthritis.~   "
11076|NCT02912208|"~     Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective~     erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option~     for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the~     limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The~     only available treatment for severe thrombocytopenia, in the presence of bleeding, is~     platelet transfusion.~      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult~     patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet~     counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well~     tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment~     of ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for~     the treatment of ITP refractory or resistant. It has been shown that in patients affected by~     MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the~     clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an~     increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic~     colonies. These results provide the rationale for pursuing further research on Eltrombopag~     for the treatment of thrombocytopenia in case of MDS.~      The study is open to adult patients with myelodysplastic syndrome (MDS) with~     thrombocytopenia and low- or intermediate-1 IPSS risk (Index Prognostic Score System).~      Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low~     prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients~     become refractory in the long term. The availability of a treatment that induces the~     increase of platelet count is extremely important, either in terms of quality of life, and~     in overall survival.~   "
11077|NCT02912195|"~     Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider~     chosen dose of IV morphine for the treatment of severe pain in the emergency department.~      Study design: Open-label, randomized controlled pilot study.~   "
11078|NCT02912182|"~     Randomized placebo controlled trial on patients suffering from acute unilateral~     vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short~     corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).~      Vestibular function as well as subjective symptoms will be estimated in the acute stage and~     regularly up to one year after the debut.~   "
11079|NCT02912169|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     Alzheimer's Disease and clinical outcomes?~   "
11080|NCT02912156|"~     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different~     Formulation of Voriconazole 200 mg Tablets in Healthy Adult Subjects.~   "
11081|NCT02912143|"~     The German Pediatric Hemophilia Research Database will collect data on the prophylactic and~     therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL)~     and living circumstances in newly diagnosed children with hemophilia.~   "
11082|NCT02912130|"~     This project will investigate the synergistic effects of Aerobic and Resistance type~     Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal~     Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.~   "
11083|NCT02912117|"~     Prospective, observational study at Stanford University Hospital comparing the Karius~     Infectious Disease Diagnostic Sequencing Assay to the final microbiologic diagnosis in~     patients with fever and neutropenia.~   "
11084|NCT02912104|"~     This project will clarify the safety and effectiveness of human amniotic epithelial cells~     transplantation for the treatment of primary ovarian insufficiency(POI) patients and provide~     a new therapeutic method for patients with infertility.~   "
11085|NCT02912091|"~     This study will look at blood sugar levels in pregnant women who have been given a~     glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help~     determine the likelihood, predictive value, adverse effects, response of patients diagnosed~     with gestational diabetes and time course of blood sugar elevation following steroids.~   "
11086|NCT02912078|"~     This study will examine recent claims regarding the beneficial effect of warming epidural~     medications in order to hasten the onset of labor analgesia.~   "
11087|NCT02912065|"~     A retrospective chart review to assess feeding tolerance in children who had been switched~     from an intact protein formula to a Peptide based formula due to feeding intolerance in a~     pediatric facility for the developmentally delayed.~   "
11088|NCT02912052|"~     A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative~     Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable~     Liver Metastasis~   "
11089|NCT02912039|"~     There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor~     in the clinical setting. The aim of this clinical investigation is to examine a prototype of~     a quantitative monitoring instrument that will meet most, if not all, of the clinical~     requirements.~   "
11090|NCT02912026|"~     Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318.~     Five healthy male subjects will receive IV and five will receive an oral solution. Blood,~     urine and faeces will be collected over a period adequate to obtain 90% recovery of parent~     compound and to determine the metabolic profile of both IV and oral forms.~   "
11091|NCT02912013|"~     The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of~     unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin~     photo-types I-VI) based on a series of multi-site clinical studies.~      The purpose of this post-marketing study is to support the claims for removal of unwanted~     hair and for permanent hair reduction in the compact version of the device.~   "
11092|NCT02912000|"~     The proposed study is a pre- /post-implementation study in a pediatric practice with a~     control practice designed to test the feasibility and effectiveness of an electronic~     screening and service delivery tool for three modifiable health risk factors in pediatrics:~     parental tobacco use, sugar-sweetened beverages consumption, and poor dental care~   "
11093|NCT02911987|"~     Low back pain is a common disorder, occurring worldwide in both males and females in all age~     groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years.~     It is currently the most frequent musculoskeletal cause of functional disability and it has~     a major socio-economic impact on today's society. Although a small percentage of persons~     with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons~     with low back pain present with symptoms of nonspecific origin. A part of these symptoms are~     only of short duration, but 23% of all people will develop nonspecific chronic low back pain~     (NSCLBP).~      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.~     Previous studies analysed the effects of various modes of exercise therapy, such as motor~     control therapy, core stability training and aerobic conditioning training. However, therapy~     outcomes can be low, and guidelines in favour of using a specific program are contradictory.~     It thus still remains unclear which therapy modality is best suited. Furthermore, no~     recommendations are available about optimal training intensities during rehabilitation of~     persons with NSCLBP.~      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low~     back pain and improvements in overall physical fitness can affect therapy outcomes in this~     population, ET specifically focussing on physical fitness can be advocated for NSCLBP~     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and~     efficient training method for improving physical fitness and health related parameters in~     healthy persons. Also, HIT resulted in successful reconditioning and improvement of~     functional and disease related outcomes in persons with other chronic diseases such as~     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies~     showed promising results for the effect of HIT on low back pain such as high intensity~     isolated, evidence is still scarce and study results are unclear because of methodological~     shortcomings.~      The aim of this randomized clinical trial study is to evaluate the effects of a HIT program~     on disease related outcomes, physical fitness and muscle contractile characteristics~     compared to a conventional rehabilitation program in persons with NSCLBP.~   "
11094|NCT02911974|"~     This is a randomized prospective clinical study comparing a fine needle biopsy device and an~     aspiration needle.~   "
11095|NCT02911961|"~     The objective of this study is to provide preliminary data to describe serum~     acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following therapeutic doses~     of acetaminophen in the setting of non-acetaminophen induced liver injury. This study will~     utilize hepatic embolization as a model of hepatic injury.~   "
11096|NCT02911948|"~     Comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec both~     in combination with metformin in Japanese subjects with type 2 diabetes mellitus~     inadequately controlled with basal or pre-mix/combination insulin therapy and oral~     anti-diabetic drugs~   "
11097|NCT02911935|"~     The main objective of the APW-RSV II clinical trial is to evaluate if the addition of~     azithromycin to routine bronchiolitis care, among infants hospitalized with RSV~     bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.~   "
11098|NCT02911922|"~     Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016~     NCCN criteria will be eligible to participate on this study.~   "
11099|NCT02911909|"~     The aim of this study is to determine if there is a difference in post operative~     rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery while using~     moderated blood flow therapy vs. standard physical therapy. All patients undergoing ACL~     reconstruction, between the ages of 18-30, that consent to taking part in the study, and~     meet eligibility criteria, will be included in the study. Patients will be followed for two~     years to determine any differences in muscle strength, thigh circumference, knee range of~     motion, pain, functional and activity levels, patient satisfaction, levels of Human growth~     hormone HGH), Insulin-like Growth Factor (IGF), and Creatine Kinase (CK), KT2000, and~     Lachman physical examination.~   "
11100|NCT02911896|"~     Impairment in physical function is a significant problem for survivors of critical illness.~     There is a growing urgency to develop a core set of outcome measures, which can be adopted~     in clinical and research practice to evaluate efficacy in response to interventions such as~     rehabilitation.~      Phase 1: Development of a new outcome measure. This study aims to examine the development of~     a single outcome measure which may be able to be utilised across the continuum of recovery~     of critical illness in the evaluation of physical function. The study will involve~     examination of two common physical function measures - the Physical Function in intensive~     care test scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new~     measure based on rasch principles which may be able to capture physical functioning changes~     in individuals with critical illness. Aims: (1) To determine the clinical utility of two~     physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital~     admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single~     measure to evaluate function in intensive care survivors using Rasch analytical principles.~      Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an~     independent validation sample.~   "
11101|NCT02911883|"~     The purpose of this study is to assess the repeatability and reproducibility of measurements~     of the vascular structures and the anatomical structures of the posterior pole of the eye~     based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.~   "
11102|NCT02911870|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC~     on cardiac repolarisation in healthy male subjects~   "
11103|NCT02911857|"~     The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this~     extension study. This extension study offers the opportunity for patients who completed~     Epoch 4 of the preceding CACZ885N2301 study to continue to be treated with ACZ885 until~     approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in~     Periodic Fever Syndromes is suspended.~   "
11104|NCT02911844|"~     The main purpose of this clinical trial is to examine the feasibility and effects of~     fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study~     will evaluate how well the drug is tolerated. The study will evaluate changes in circulating~     hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma~     biomarkers after the administration of fulvestrant. Changes in tricuspid annular plane~     systolic excursion, stroke volume index, right ventricular fractional area change, and other~     echo parameters after fulvestrant administration will be evaluated as well as changes in~     distance walked in six minutes.~   "
11105|NCT02911831|"~     The objective of this study is to determine the effect of 1g of IV tranexamic acid given~     within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.~   "
11124|NCT02911584|"~     This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse~     Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial~     is designed to test the clinical and functional effects of the two different laparoscopic~     procedures in terms of anatomical correction of the prolapse, post-operative and long term~     morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a~     quality of life questionnaire.~   "
11106|NCT02911818|"~     This is a 52 week, single center, open-labeled, randomized controlled trial.~      A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as~     contraindications to weight loss, will be randomly assigned to one of three treatment~     groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and~     Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide~     (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e.,~     Multi-Component Intervention).~      Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the~     first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration~     of counseling visits recommended by CMS. Counseling sessions will be delivered by a~     physician, nurse practitioner or registered dietitian (RD) working in consultation with the~     former providers.~      Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24,~     36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide~     groups to monitor their response to the medication. These visits are included for subjects~     in CMS-Alone to match the intensity of medical care provided the two other groups.~      The primary outcome is % reduction in initial body weight, as measured from randomization to~     week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%,~     >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the~     proportion of participants who meet the three categorical weight losses at this time. The~     secondary efficacy measures include changes (from randomization to week 52) in~     cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating~     behavior, appetite, sleep, and satisfaction with weight loss.~      Safety endpoints will include physical examination, adverse events (AEs), standard~     laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating~     Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).~      Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a~     randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the~     Multi-Component Intervention provides >80% power to detect the two primary contrasts to be~     statistically significant. This estimate allows for 20% attrition during the 52-week trial,~     resulting in approximately 40 treatment completers per group. The ITT longitudinal~     statistical design will further improve power by allowing the inclusion of available data~     for non-completers and the adjustment of possible variance reducing baseline covariates.~   "
11107|NCT02911805|"~     This study will determine whether blood biomarker changes predict sight-saving benefits of~     exercise.~   "
11108|NCT02911792|"~     The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or~     without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated~     group will serve as controls for improved glycemic control, since the investigators have~     shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM~     patients.~   "
11109|NCT02911779|"~     In order to determine the optimal angle to perform an episiotomy, the investigators assessed~     the angle of marked episiotomy lines at the first stage of labor and at the time of crowning~     of the head.~      Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°,~     and 60° angles from the midline, at the first stage of labor, in women with singleton~     pregnancies. The angles of the marked lines were measured again at crowning of the head.~     Mediolateral episiotomy was performed only for obstetric indications.~   "
11110|NCT02911766|"~     Chlorhexidine is the gold standard of dental plaque prevention, but which concentration is~     the most effective is not known. The aim of the present study was to compare the plaque and~     gingivitis inhibiting effect of commercial products containing 0.2%, 0.12% and 0.06%~     chlorhexidine in a modified experimental gingivitis model.~      In three groups of healthy volunteers, experimental gingivitis was induced and monitored~     over 21days, simultaneously treated with the commercial solutions containing 0.2%, 0.12% and~     0.06% chlorhexidine. The maxillary right quadrant of each individual received mouthwash~     only, whereas the maxillary left quadrant was subject to both rinsing and mechanical oral~     hygiene. Compliance and side effects were monitored at days 7, 14, and 21. Plaque and~     gingivitis scores were obtained at baseline and day 21.~      The commercial mouthwash containing 0.2% chlorhexidine resulted in statistically~     significantly lower plaque scores than the 0.12 and 0.06% mouthwashes after 21 days use,~     whereas no statistically significant difference was found between the effect of the two~     latter mouthrinses.~      A commercial available mouthwash containing 0.2% chlorhexidine proved statistically~     significant better effect in preventing dental plaque than 0.12% and 0.06% solutions.~   "
11111|NCT02911753|"~     This study aims to 1) assess the feasibility and acceptability of a prescribed beverage~     intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess~     preliminary effects of the beverage intervention on cholesterol and triglyceride levels as~     well as other markers of health such as blood pressure, glucose and markers of inflammation.~     This project, if successful, will provide early evidence that targeting dietary behavior~     around beverage intake could be a novel and easily adopted approach to reduce the burden or~     delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of~     the proposed project is the identification of feasible and appropriate beverage intervention~     strategies to improve engagement and adherence to dietary modification approaches for~     control of metabolic health indicators in this vulnerable ethnic group.~   "
11112|NCT02911740|"~     Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013,~     there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to~     TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be~     confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia.~     In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis~     based on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients~     are co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis~     patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and~     disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management,~     which in turn results in unnecessary toxicity, antibiotic resistance, and monetary~     expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a~     simple urine dipstick test and evaluating physician response to new diagnostic testing, in~     order to reduce misdiagnosis and improve health outcomes in the HIV population.~   "
11113|NCT02911727|"~     Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine~     for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative~     pain but improvements in management of pain may change this situation and make early~     discharge possible. However, several aspects need to be considered.~      The aim of this project is to evaluate fast-track discharge for multiparas after elective CS~     concerning neonatal and maternal complications as well as the parents' sense of security and~     well-being.~      The study is a randomized controlled trial including 142 women allocated to either discharge~     after 24-28 hours or standard discharge after at least 48 hours after elective CS.~      This study will be among the first evaluating fast-track discharge after CS in a European~     context. If a positive outcome is achieved, we expect that fast-track discharge can be~     implemented with improved quality and reduced costs in postnatal care following elective CS.~   "
11114|NCT02911714|"~     Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in~     the early detection of kidney transplant complications, such as delayed graft function (DGF)~     and acute allograft rejection. The technique uses an intravenous contrast agent to improve~     organ visualization with standard duplex ultrasound equipment. A number of FDA-approved~     agents, including Optison, Definity and Lumason are widely used to improve visualization in~     technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced~     ultrasound of the liver. The specific aims of this study are to: develop, implement and~     refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney~     allograft visualization; determine associations between contrast-enhanced ultrasound and~     patterns of allograft injury consistent with delayed graft function; and to compare~     contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from~     other causes of dysfunction.~   "
11115|NCT02911701|"~     NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure~     over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the~     setting of preeclampsia have not been well studied. This study aims to assess the effect of~     avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with~     preeclampsia with severe features. Eligible women will be randomized to receive either~     acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies~     for pain control although ibuprofen has better pain control than acetaminophen. The primary~     outcome will be duration of postpartum severe-range hypertension.~   "
11116|NCT02911688|"~     To study the effects of 1200mg gamma tocopherol (yT), a form of vitamin E, given daily on~     the response of the airway in mild asthmatics after exposure to ozone (O3)~   "
11117|NCT02911675|"~     Traumatic brain injury (TBI) is a leading cause of death following injury in civilian~     populations and is a major cause of death and disability in combat casualties. While primary~     brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of~     secondary injury mechanisms which occur as part of the downstream effects of the primary~     damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated~     intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration~     of elevated ICP is strongly associated with poor long term patient outcome.~      Currently, there are two invasive techniques that are used at our facility for monitoring~     ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic~     pressure monitor (IPM), also known as a camino, into the brain tissue that measures and~     displays ICP continuously. The second method requires placement of an extracranial~     ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows~     for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull~     when it is open.~      While clinical practices vary greatly across institutions, current clinical practice at our~     institution when using the EVD for ICP management is to allow continuous therapeutic CSF~     drainage and to manually close the drain for ICP assessment on an hourly basis. However, in~     a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD~     placement, a spike in ICP was noted to correspond with the clamping of the EVD which often~     remained elevated for 15-30 minutes before returning to baseline. Due to the strong~     association between poor patient outcome and elevated ICP, this finding is alarming. These~     findings have important implications for procedures to not only treat elevated ICP, but also~     prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to~     prospectively investigate the association between EVD clamping and elevated ICP.~      Specifically, this study has 2 main objectives:~        1. Evaluate the need for an optimized device that can simultaneously measure intracranial~          pressure and drain CSF without requiring potentially harmful clamping.~        2. Provide data in support of retaining or modifying current clinical practices regarding~          intermittent versus continuous monitoring during periods of therapeutic drainage of~          CSF.~   "
11118|NCT02911662|"~     This is a prospective randomized controlled day comparing the efficacy of three-day~     antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard~     seven-day treatment. Half the patients will receive 3-day treatment and the other half will~     receive 7 days of antibiotics.~   "
11119|NCT02911649|"~     Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC),~     which can have profound effects on their well-being. Although physical activity has been~     shown to improve CRF, the recommended levels are generally not met. Step count and distance~     traveled information can help individuals to increase their physical activity. Wearable~     technology (WEAR) provides the user with feedback of their physical activity which can~     motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary~     behaviour and physical activity may also reduce sedentary behaviour.~      The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary~     behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants~     in this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a~     three-month intervention. Assessments at baseline, post-intervention and a 3-month follow up~     will evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR~     devices.~      The results from this study will provide evidence-based knowledge on the impact of WEAR and~     EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the~     PC population. These results can shape the development of programming for CRF and the use of~     scale-able technology-based interventions/approaches in this population.~   "
11120|NCT02911636|"~     Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with~     simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5~     fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes +~     6-18 months of ADT~   "
11121|NCT02911623|"~     To observe early safety and performance of the Shockwave Medical Lithoplasty® System~     (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and~     3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively~     deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic,~     infrapopliteal arteries.~   "
11122|NCT02911610|"~     The use of arthroscopy with the surgery of wrist fractures has a great health and economic~     impact (prolongs the time of surgery, requires adequately trained personnel, increases the~     time and surgical expenses and the risk of complications, however, in return ameliorate the~     prognosis and improves the functional recovery). There are few clinical trials showing a~     sufficient level of evidence in comparing the results of the surgical treatment of these~     fractures with volar plate and added arthroscopy so it is necessary to perform a clinical~     trial with an appropriate design and a sufficient sample size to elucidate the usefulness of~     arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and~     controlled clinical trial to adequately analyze the role of arthroscopy in the surgical~     treatment of wrist fractures in the investigators hospitals.~      The main objective of the study is to probe the arthroscopy effectiveness in the~     functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist~     function) between the treatment groups of the trial at 12 months after surgery and for this~     the investigators plan a phase IV multicenter clinical trial.~   "
11126|NCT02911558|"~     The aim of the study is to estimate the impact of the implication of a Mobile Team of~     Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The~     Mobile Team of Palliative of Foch hospital Care was created in March, 2011.~   "
11127|NCT02911545|"~     Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective~     alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There~     are yet limited real life data on outcomes following elective cardioversion in AF patients~     treated with NOACs. The aim of this study is to investigate the complications and the use of~     NOACs in AF patients undergoing cardioversion.~   "
11128|NCT02911532|"~     The purpose of this study is to determine whether tissue engineering conjunctiva is~     effective in the treatment of pterygium and atretoblepharia.~   "
11129|NCT02911519|"~     This study evaluates the addition of psychoeducation to treament as usual in the treatment~     of adults with schizophrenia for relapse prevention. Half of partipants will receive a brief~     (5 sessions) psychoeducation intervention and treatment as usual in combination, while the~     other half will receive treatment as usual only.~   "
11130|NCT02911506|"~     The aim of the study is to evaluate the impact of sleep quality on extubation failure rate~     in intensive care unit patients at high risk.~   "
11131|NCT02911493|"~     To determine the change in sedentary time and number of steps/day for older patients with~     heart failure at risk for mobility disability who receive a program to decrease sedentary~     behavior versus a standard program to increase exercise.~   "
11132|NCT02911480|"~     The current study is designed as a phase I multiple dose study to evaluate the~     pharmacokinetics and bioavailability of [14C]-labelled oxytocin in healthy women.~   "
11133|NCT02911467|"~     This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging~     with Hyperpolarized Pyruvate (HP) (13C) as a predictive response biomarker to androgen~     signaling inhibition in patients with castration-resistant prostate cancer.~   "
11134|NCT02911454|"~     A prospective, multi-country, open label study to describe the stool characteristics and~     behaviour as well as the parents' experience in infants receiving a recently launched infant~     formula in a real life situation.~   "
11135|NCT02911441|"~     This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms~     of anxiety and depression living in insecure environments using a randomized controlled~     methodology. Key outcomes of interest include maternal mental health and infant cognitive~     development. The intervention will be delivered by community mental health workers who will~     be trained to administer 8 to 12 cognitive behavioral therapy sessions.~   "
11136|NCT02911428|"~     The purpose of this study is to evaluate the post-vaccination immune status at different~     time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen~     of product administration; and, to assess safety of medicinal product GamEvacVector-Based~     Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a~     half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.~   "
11137|NCT02911415|"~     The purpose of this study is to evaluate the post-vaccination immune status at different~     time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen~     of product administration; and, to assess safety of medicinal product GamEvac-Combi -~     Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the~     immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic~     doses.~   "
11138|NCT02911402|"~     Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions~     Astrolabe, sometimes there is a risk of very significant dehydration. A special unit~     specialized in the fundamental study of the vestibular system (inner ear), sensory organ at~     the base of visual-vestibular conflict inducing this syndrome, also provides medical support~     for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly~     present. The goal of the study is to assess the frequency of occurrence of this sea sickness~     syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality~     traits, anxiety / stress) without changing habits on board for those on board taking a~     antinaupathique treatment given by the ship's doctor. This study will be done in~     collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER~     specialized in extreme environments (Belgium). The ultimate goal will be to provide the best~     recommendations and the best treatment regimen to alleviate as best as possible the symptoms~     of people on board of the Astrolabe so scientists on board can perform their work.~   "
11139|NCT02911389|"~     The purpose of this study is to determine if unsupervised, home rehabilitation delivered by~     a web-based platform or paper manual is a safe and effective alternative to outpatient~     physical therapy after total knee replacement.~   "
11140|NCT02911363|"~     The main purpose of this study will be to two-fold; firstly to determine whether the use of~     a Captivator tissue cassette has an effect on the preservation of tissue histology~     (minimizing artifactual curling) , and secondly to determine whether the use of a~     intraprocedural cassette is practical. The investigators believe that this will greatly aid~     in elucidating the best technique for optimizing performance of EMR for esophageal lesions.~   "
11141|NCT02911350|"~     The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel~     and Radiation therapy are effective in treatment of locally advanced prostate cancer~   "
11142|NCT02911337|"~     The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle~     modification program on symptoms and signs of heart failure as well as laboratory and~     echocardiographic measures of cardiac structure and function. This will be a 6 month trial~     in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction~     (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight~     management 15 week lifestyle change program which will involve weekly visits that rotate~     among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with~     the research Registered Nurse. Each patients baseline data will be used as the control and~     compared with the same measurements at the 6 month end point.~   "
11165|NCT02911038|"~     The aim of this observational study is: producing complete dental prosthesis with the aid of~     CAD-CAM (Computer aided design & manufacturing) - 3D printing (Stereolithography) technology~     - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles~     composite completely characterized.~   "
11143|NCT02911324|"~     The purpose of this pilot research study is to test the effects of a medication called~     nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will~     receive either nabilone on its own, or nabilone in combination with a form of~     cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone~     is a synthetic cannabinoid and acts on the brain's endocannabinoid system, which has been~     hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of~     chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.~   "
11144|NCT02911311|"~     Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic~     retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40~     years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection~     of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal~     neovascularization(NV). The purpose is to assess and compare the efficacy and safety between~     intravitreal injection of conbercept and PRP.~   "
11145|NCT02911298|"~     This is a Phase I, open label, single-site trial to evaluate the in vivo release~     characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to~     disintegrate in the large intestine. This will be examined by means of metronidazole plasma~     levels and scintigraphic images in healthy subjects. Overall, nine subjects will be~     evaluated for each formulation prototype. Two formulation prototypes will be investigated.~     Each subject will receive one radio-labelled capsule only.~   "
11146|NCT02911285|"~     As a result of sustained operations in Afghanistan and Iraq, there are an increasing number~     of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress~     disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at~     increased risk for developing other mental health problems (e.g., depression, anxiety),~     suicidal ideation and attempts, medical problems, reduced resiliency and military readiness,~     vocational problems, and family/social impairment. This study will determine the benefits of~     N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress~     disorder (PTSD) among military Veterans.~   "
11147|NCT02911272|"~     Objective: To compare active labour outcomes in nulliparous women at term supervised with a~     partograph with the action line placed at either 2 hours or 4 hours and to determine whether~     the 2-hour action line placement is better for the prevention of prolonged labour.~      Design: Randomised controlled trial.~      Setting: A university teaching hospital in Nigeria.~      Population: Nulliparous women in labour at term.~      Method: Nulliparous women in labour were randomly supervised with a partograph with the~     action line placed at 2 hours (n=320) or 4 hours (n=320). Oxytocin augmentation, when~     required, was used only at the 2-hour (n=87) or 4-hour (n=61) action lines. Progress~     monitoring was the same in both groups.~      Main outcome measure: The primary outcome measure was the prolonged labour rate. The~     secondary outcome measures were the mode of delivery and neonatal outcome.~   "
11148|NCT02911259|"~     The level of suction on post-operative chest tubes after video-assisted thoracoscopic~     surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of~     drainage. These results, however, are based on traditional drainage systems with water seal~     and need to be confirmed using digital drainage systems.~      Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of~     -10 cmH2O when looking at chest tube duration and complications.~   "
11149|NCT02911246|"~     Malnutrition is defined by an energy supply deficit, protein, macro-molecules or~     micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of~     the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences~     their prognosis. Studies over the past decade have shown that nutritional deficiency~     increases the morbidity and mortality in intensive care.~      Several clinical and biological parameters were evaluated as markers of malnutrition,~     including the ratio of urea / urine creatinine.~      The report would identify patients in a state of malnutrition, to optimize their nutritional~     care.~      This setting is easy to obtain in all patients by simple urine collection unlike other~     clinical and biological criteria of resuscitation malnutrition assessment.~      This ratio of urea / urien creatinine would optimize energy intake of critically ill~     patients, for which nutritional management methods are widely debated.~   "
11150|NCT02911233|"~     Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one~     individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling~     hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves~     the administration of exogenous human FVIII to restore normal hemostasis. The main~     complication of the substitutive treatment of hemophilia A is the development, in 15 to 30%~     of the cases, of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant~     activity of therapeutically administered FVIII. In 2003, the average annual cost of care for~     a patient with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France~     (6000 patients), represents an annual budget of 378 million euros.~      In order to reduce the cost of treatment and to bypass this complication, different~     therapeutic strategies (new products or adjunctive therapeutic options) have been explored,~     including platelet infusion, tranexamic acid, amino caproic acid, molecules that block~     tissue factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and~     antibodies directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble~     thrombomodulin (Solulin) have been developed. This molecule may be used to partially correct~     the premature lysis defect in Factor VIII deficient plasma through an activated TAFI -~     dependent mechanism.~      With a long half-life (15- to 30-hour) and effective dose range estimated to range from the~     sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly~     basis and provide the basis for a factor-sparing regime that would cut costs and make~     therapy more widely available. However, before proceeding to advanced trials, safety~     concerns stemming from the anticoagulant properties of Solulin must be addressed. The~     development of Solulin mutants lacking protein C activation capacity would make this concern~     redundant. At the same time, such mutant molecules are likely to possess an effective dose~     range.~      Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking~     protein C activation capacity with respect to their ability to stabilize fibrin clots in~     whole blood of humans with different coagulation factor deficiencies (hemophilia A,~     hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).~   "
11166|NCT02911025|"~     The purpose of this study is to monitor the effect of Clobazam on sleep and daytime~     alertness in people with Epilepsy.~   "
11170|NCT02910973|"~     Persistent chronic inflammation is an important underlying event in multiple diseases~     including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These~     disorders are characterized as inflammatory in part because of the important mediating role~     of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether~     transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease~     the inflammatory cytokine response in healthy individuals.~   "
11171|NCT02910960|"~     This is a randomized prospective clinical study comparing the Acquire Biopsy Device to~     SharkCore Biopsy Device.~   "
11151|NCT02911220|"~     The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later~     symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory~     drugs (NSAIDs), a sinonasal polyposis and eosinophilia.~      Unlike allergic asthma, this form does not today demonstrated its genetic character.~     However, the existence of familial forms of asthma in this region Pays de La Loire led us to~     hypothesize the existence of genetic variations can explain some familial forms of~     non-atopic asthma. Corresponding genes may be relevant to understanding the~     pathophysiological pathways involved in the more common sporadic forms.~      The investigators propose a study combining genetic linkage analysis and complete sequencing~     exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The~     clinical stage essential for mutation identification is to identify and recruit large~     families with members affected by non-atopic asthma and ensure accurate phenotyping of all~     individuals recruited over several generations.~      The aim of this study is to create a cohort of families who have more members within them~     non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family~     linkage study will then reveal the presence or absence of genetic variations associated with~     intrinsic asthma.~   "
11152|NCT02911207|"~     There are very few studies on emotion management in chronically ill patients. They usually~     include small sample size (less than 30 persons) and are not randomized controlled trials.~     However, emotion management is an essential coping skill in mental well-being and quality of~     life and is the subject of numerous studies in psychology.The investigators hypothesized~     that a creative and physical activities combination in chronically ill will promote the~     strengthening of emotion management skill. The investigators will conduct an innovating~     study combining quantitative and qualitative variables in a randomized controlled trial to~     confirm our hypothesis.~   "
11153|NCT02911194|"~     Under double-blind, placebo-controlled, cross-over conditions, the short-term effects of use~     of A1 beta casein free milk (a2 milk) and milk containing A1 beta casein will be compared in~     a sample of pre-pubescent boys diagnosed with an autism spectrum disorder (ASD) with~     concurrent features of attention-deficit hyperactivity disorder (ADHD).~   "
11154|NCT02911181|"~     Observational study to investigate nutrition state in all admitted patients in ICU.~     Measurement by BIVA and SNAQ score.~   "
11155|NCT02911168|"~     The purpose of this study is to compare the proximal intercostal block to the more medial~     (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the~     proximal intercostal block will allow for improved needle visualization, shorter block time,~     and improved safety profile compared to the classic paravertebral bock.~   "
11156|NCT02911155|"~     Background:~      The field of nuclear medicine has changed a lot in the past decades. Technology has gotten~     better, so patients are exposed to less radiation. But now workers are doing procedures more~     often and using lead aprons less. So they may be exposed to more radiation. This may put~     them at higher risk for cancers and other health problems that are related to radiation.~     Researchers want to collect data from technologists to learn more about the risks and~     appropriate doses of radiation.~      Objective:~      To learn more about the risks and appropriate doses of radiation for nuclear medicine~     technologists.~      Eligibility:~      Adults who were first certified in nuclear medicine technology in the United States after~     1980. They must be living in the United States. They must not be participants in the USRT~     study.~      Design:~      Participants will be recruited online.~      Participants will complete an online survey. It will take about a half hour. This will have~     questions about their work with nuclear medicine procedures. There will be questions about~     the kinds of procedures and how often they do them.~      Participants will give a short work history. This will include the names of current and past~     employers.~      Participants will allow researchers to get records of their film badge dose readings. These~     will come from dosimetry providers.~      Dosimetry data will not be shared with participants. Researchers can t ensure the how~     accurate or complete the data are.~   "
11157|NCT02911142|"~     Background:~      Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers~     want to see if a drug called lenalidomide along with common chemotherapy drugs may be~     effective in treating PEL.~      Objective:~      To test a new treatment for PEL.~      Eligibility:~      People ages 18 and older with PEL.~      Design:~      Participants will be screened with blood tests, imaging studies, a physical exam, and other~     tests.~      Participants will have tests to evaluate their disease. These may include:~      Blood tests~      Scans~      Lumbar puncture. Fluid around the spinal cord will be removed with a needle.~      Bone marrow removed with a needle and studied~      Samples of skin or lymph nodes removed~      Fluid removed from around organs~      Lung and eye tests~      Tubes with cameras taking pictures of airways or digestive tract~      Participants will take lenalidomide pills for 10 days. They will keep a pill diary.~      Participants will have a catheter (small tube) placed in the large vein in the arm or chest.~      Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days.~     This will be repeated in 21-day cycles. Most participants will have 6 cycles.~      Participants will get the drug filgrastim by injection under the skin. They will get the~     drug methotrexate injected into the spinal fluid.~      During the study, participants will have the following tests done at least once:~      Medical history~      Physical exam~      Blood, urine, and stool tests~      Lesions photographed and measured~      Lumbar puncture~      Participants will have follow-up visits for 5 years. They will repeat the screening tests~     plus have urine and stool tested.~      Participants may be contacted later by phone to see how they are doing....~   "
11167|NCT02911012|"~     The aim of this study is to overcome the current limits of the scoring systems used to~     predict both the thrombotic (VTE) and hemorrhagic (BLD) risk for the patient. The main~     problem of these scoring systems is due to the high rigidity related to the score assigned~     at each risk item. The presence of an item assigns the full score for that item, without the~     possibility to moderate that item's score. The final class of risk, for the patient, is the~     sum of the scores of the selected items. The approach used for the assessment is based on~     the presence or absence of certain items that will be summed.~      Starting from scoring system currently used for VTE (PADUA, CAPRINI, KHORANA) and also for~     BLD (IMPROVE), we will integrate all common items in a single scoring system managed by risk~     management algorithms that can identify the different classes of risk.~   "
11168|NCT02910999|"~     This study intends to describe the real-life effectiveness and safety of nivolumab in~     advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the~     quality of life.~   "
11158|NCT02911129|"~     Background:~      After a stroke, the balance between the two halves of the brain can be lost. This may cause~     people to lose the ability to perceive a side of space. This is called neglect. Having~     people wear prism glasses (called PA) can reduce neglect symptoms. Researchers want to find~     out more about how PA, and whether it restores the balance in the brain.~      Objective:~      To learn how prism adaption temporarily changes vision and connections in the brain.~      Eligibility:~      People ages 18 75 with brain damage of the right side of the brain from a stroke or other~     cause, leading to neglect.~      Healthy volunteers ages 18 75.~      Design:~      Participants will have 1 3 visits.~      Participants will be screened with a neurological exam. They may also have:~      Tests of thinking and vision~      Tests to see which eye and hand they prefer~      A pregnancy test~      All participants will:~      Answer questions about their personality, style of thinking, and beliefs.~      Do simple tasks on paper or computer~      Have magnetic resonance imaging. They will lie on a table that can slide in and out of a~     cylinder in a strong magnetic field. Participants will lie still or do computer tasks in the~     scanner.~      Participants may also have:~      Transcranial magnetic stimulation. A brief electrical current passes through a wire coil on~     the scalp. This creates a magnetic pulse that affects brain activity. Participants may be~     asked to tense certain muscles or perform simple actions or tasks.~      PA. They will sit in front of a board and point to a dot on it while they wear prism glasses~     that shift vision to the left or right.~   "
11159|NCT02911116|"~     Background:~      Uveitis is an inflammation of the eye that can cause vision loss. It is treated with~     medications and sometimes surgery. However, in many people, treatment does not always~     prevent loss of vision. A new medication, ustekinumab, reduces inflammation in patients with~     other inflammatory diseases. Therefore, it might be helpful in treatment of uveitis.~      Objective:~      To see if ustekinumab is safe and can help people with uveitis.~      Eligibility:~      People ages 18 and older with uveitis~      Design:~      Participants will be screened with:~      Medical and eye disease history~      Physical exam~      Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures~      are taken of the inside of the eye.~      Blood and urine tests~      Tuberculosis test~      Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include:~      Medical and eye disease history~      Physical and eye exams~      Blood and urine tests~      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is~      injected into the tube. The dye travels through the veins up to the blood vessels in the~     eyes. A~      camera takes pictures of the dye as it flows through the blood vessels in the eyes.~      Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper~      arm, leg, or abdomen.~      Participants will have their uveitis monitored and receive standard uveitis care during the~     study.~   "
11160|NCT02911103|"~     Researchers want to test a procedure called deep brain simulation (DBS) to treat focal hand~     dystonia (FHD). A device called a neurostimulator is placed in the chest. It is attached to~     wires placed in brain areas that affect movement. Stimulating these areas can help block~     nerve signals that cause abnormal movements.~      Objectives:~      To test DBS as treatment for FHD. To learn about brain and nerve cell function in people~     with dystonia.~      Eligibility:~      People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least~     twice~      Design:~      Participation lasts 5 years.~      Participants will be screened with:~      Medical history~      Physical exam~      Videotape of their dystonia~      Blood, urine, and heart tests~      Brain MRI scan~      Chest X-ray~      Neuropsychological tests: answering questions, doing simple actions, and taking memory and~     thinking tests.~      Hand movement tests~      Participants will have surgery: A frame fixes their head to the operating table. A small~     hole is made in the skull. Wires are inserted to record brain activity and stimulate the~     brain while they do simple tasks. The wires are removed and the DBS electrode is inserted~     into the hole. The neurostimulator is placed under the skin of the chest, with wires running~     to the electrode in the brain. They will have CT and MRI scans during surgery.~      Participants will recover in the hospital for about 1 week.~      The neurostimulator will be turned on 1 4 weeks after discharge. Participants will have~     regular visits until the study ends. Visits include:~      Checking symptoms and side effects~      MRI~      Movement, thinking, and memory tests~      If the neurostimulator s battery runs out, participants will have surgery to replace it.~   "
11161|NCT02911090|"~     The purpose of this data registry is to prospectively collect data from patients referred to~     an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term~     patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and~     endometriosis.~   "
11162|NCT02911077|"~     Background:~      Many bacteria live in the gut. The gut is the tube that moves food from the mouth through~     the stomach to the intestines. Heavy alcohol use disturbs these bacteria. There is evidence~     that the bacteria in the gut may affect anxiety and depression. Researchers want to learn~     more about these bacteria in order to better treat diseases such as alcohol dependence.~      Objective:~      To identify the different bacteria that live in the mouth and gut. Also, to learn if these~     bacteria change as a person goes through alcohol detoxification.~      Eligibility:~      People ages 18 and older who:~        -  Enrolled in screening protocol 14-AA-0181~        -  Are going through detoxification treatment at the Clinical Center~      Design:~      Participants will have physical exams.~      Participants will answer questions about:~        -  Anxiety and depression~        -  Alcohol use~        -  Sleep~        -  Abdominal and oral health~        -  Diet~      Participants will keep a regular record of their diet.~      Participants will have breath alcohol analysis 4 times per day.~      Participants will provide stool and oral specimens at most once a day for the first week.~     Then, they will provide them once a week while they are at the Clinical Center.~        -  For the oral specimen: A small brush rubs the tongue. They may not eat, drink, or~          perform oral care within 2 hours of collection.~        -  For the stool specimen: They will receive a container that fits in the toilet. They~          will let the nurse know right away when the sample is ready.~      Participants will have a dental visit. This consists of an oral exam and oral health~     assessment. The dentist may recommend a cleaning or dental X-rays.~   "
11163|NCT02911064|"~     The goal of this research study is to learn if there is a difference between your~     expectations of how well you will perform daily living activities after short-term inpatient~     rehabilitation and the doctor's expectations of how well you will perform daily living~     activities.~   "
11172|NCT02910947|"~     Two ultrasound guided techniques to give postoperative pain relief to the patients following~     abdominal surgeries would be compared using scoring systems for pain relief and scientific~     methods. while one technique is routinely used, other i.e quadratus lumborum has been~     recently described and relies on posterior deposition of the drug. Both the techniques are~     safe and ultrasound imaging is to be used for guidance.~   "
11173|NCT02910934|"~     This study aims to provide National Malaria Control Programs (NMCP), international donors~     and other key stake holders with clear evidence on the impact and cost-effectiveness of~     using indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high~     transmission area that has universal long-lasting insecticidal net (LLIN) coverage.~      The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This~     is a high transmission area with a malaria parasite prevalence of 54% in children, The~     Ministry of Health distributed LLINs in Mopeia in 2014-2015.~      A simplified census will take place in mid-2016 to determine the number of children five~     years of age and under in the district, enumerate and map the households.~      From the 115 villages/bairros existent in Mopeia, 86 clusters will be selected and~     randomized to either receive IRS with Actellic according to President's Malaria Initiative~     Africa Indoor Residual Spraying Project (PMI-AIRS) standard procedures (43 clusters) or no~     IRS (43 clusters). From each of these clusters, a cohort of 18 children five years of age~     and under will be followed monthly to assess malaria incidence at the community level in the~     two study arms. There will be 774 children in the IRS arm and 774 children in the no-IRS arm~     (total cohort will be 1548). Additionally, the routine health centre reporting system will~     be strengthened to assess malaria incidence in children five years of age and under by~     passive case detection. Two cross sectional studies in April 2017 and April 2018, will~     assess changes in net use, health seeking behaviour and malaria prevalence at community~     level.~      Entomological data will be collected from both IRS and control areas to assess the vector~     dynamics and insecticide resistance pattern of the local vector populations from each study~     arm. Data on the costs of the intervention as well as health-related expenditure at health~     system and household levels will be collected prospectively throughout the study. These~     costs will be determined using both health system and societal perspective.~      The incidence rate in control and intervention areas will be combined with the micro-costing~     data to calculate the cost per case averted at community and health facility level.~      These findings will be disseminated to the NMCP and international donors and stakeholders to~     complement the WHO guidance on combining indoor residual spraying and long-lasting~     insecticidal nets.~   "
11174|NCT02910921|"~     This trial is collaboration between Mayo Clinic, Second Opinion Health (Simon Bloch,~     simon@somobilehealth.com 408-981-3814) and Allergan. Mayo Clinic investigators are~     conducting the clinical trial, Second Opinion Health is providing the software for use in~     the trial (Migraine Alert app for data collection, analysis and machine learning~     algorithms), and Allergan is providing funding.~      The investigators hypothesize that the use of a mobile phone app and Fitbit wearable to~     collect daily headache diary data, exposure/trigger data and physiologic data will predict~     the occurrence of migraine attacks with high accuracy. The objective of the trial is to~     assess the ability to use daily exposure/trigger and symptom data, as well as physiologic~     data (collected by Fitbit) to create individual predictive migraine models to accurately~     predict migraine attacks in individual patients via a mobile phone app.~   "
11175|NCT02910908|"~     Elderly (i.e.>75 yrs) represent about 40% of incident dialysis patients in the French REIN~     Registry and are growing population in high income countries. Those elderly patients with~     CKD have a high risk of dying within the first months of dialysis start or could have a good~     long-term prognosis suggesting kidney transplantation access. Elderly patients with CKD also~     have a higher risk of dying than reaching ESRD. Therefore, outcomes of elderly patients with~     advanced CKD need to be better described and understood to be able to give accurate~     information to the patients and their relatives and help decision making concerning the~     treatment strategy including several options (i.e preemptive kidney transplantation, in~     center or home dialysis and conservative care). In France we have information about patients~     who started dialysis with French dialysis registry (REIN) but not about elderly patient~     treated with conservative care. Then we don't have information about description of the~     therapeutic project in this population and their evolution in a prospective cohort design.~     Finally we need to identify patients with high risk of early mortality to help shared~     decision making for better care organisation.~      The project of the study is the development of a French multicenter prospective cohort~     including elderly patients more than 75 years old reaching ESRD. Objectives are as follow:~      Description of the characteristics of the population such as, clinical and social~     conditions, medicine treatment, therapeutic project declared by nephrologist and laboratory~     value at inclusion.~      Description of the evolution of therapeuic project, kidney function and the outcomes defined~     as death or dialysis or kidney transplantation.~      Development of a mortality prognosis tools to help decision making in this population.~   "
11176|NCT02910895|"~     Outside the setting of well-designed prospective clinical studies, the current standard~     preoperative RT should be a conventionally 1,8-2 Gy fractionated regimen to a total dose of~     50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also~     unlikely to assume a uniform radiotherapeutic management to be optimal for all sarcomas~     alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated~     in the past and should be further exploited in the future, but the practical implementation~     in humans is hampered by the rarity of the disease. This platform may form the basis for~     preclinical radiotherapy investigations.~   "
11177|NCT02910882|"~     This is a single arm phase II trial assessing the potential activity of combination PEGPH20~     plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic~     adenocarcinoma.~   "
11178|NCT02910869|"~     This observational study will investigate the potential clinical utility of the Pathway Fit®~     test by investigating whether patients who successfully lose weight (defined as losing at~     least 5% of body weight 8 weeks after initiation) in the MOVE! or TeleMOVE! Weight~     Management programs have a distinct nutrigenetic profile over those that were unable to lose~     a significant amount of weight. We will use electronic records to identify all individuals~     who have successfully completed the MOVE! program (i.e. attended the full 8 week course) or~     TeleMOVE! program. In addition we will find age- and gender- matched individuals who~     attended and completed the MOVE! or TeleMOVE! programs but did not lose weight. After~     completion of the MOVE! or TeleMOVE! programs Veterans will submit a saliva sample for the~     Pathway Fit® test. Also, blood will be collected for storage for further studies on~     metabolomics. The start and end weight of all participants will be recorded. The nutrigenic~     profiles of those with successful weight loss will be compared to those less successful to~     determine if this cohort has a particular genetic profile.~   "
11227|NCT02910245|"~     This project is a double-blind, randomized, placebo-controlled, multicenter trial in the~     Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized~     6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM)~     will be performed in order to optimize treatment outcomes and objective endoscopic endpoints~     will be used.~   "
11179|NCT02910856|"~     ELDERL-IE is a multicenter national prospective observational study.~      The main objective is to describe geriatric characteristics (comorbidities, cognitive~     status, autonomy, nutritional status, balance and walking) in patients aged 75 years or~     older with infective endocarditis (IE).~      The secondary objectives are to assess the impact of geriatric features on the medico -~     surgical care and on morbidity and mortality at 3 months after the end of the~     hospitalization, and to describe the initial clinical presentation and diagnostic modalities~     in the IE elderly.~   "
11180|NCT02910843|"~     Despite treatment of locally advanced rectal cancer relapses are frequent. Several attempts~     to improve these results with therapy intensification have shown modest effect on disease~     free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and~     cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib~     is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this~     trial investigates if similar results can be achieved as with sorafenib or cediranib.~   "
11181|NCT02910830|"~     The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first~     multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It~     guarantees its methodology great representativeness and therefore an interesting material~     for the study of risk factors in the population. In addition, it should have little here~     Radiographs of hands for all its patients. It therefore has the opportunity to study a~     possible relationship between tobacco and hip osteoarthritis , knee and hand but also to~     study the relationship between tobacco and structural evolution of hip osteoarthritis and /~     or symptomatic knee.~   "
11182|NCT02910817|"~     a quasi-experimental study to investigate whether metformin co-treatment would improve IVF~     outcomes in overweight and obese women with PCOS.~   "
11183|NCT02910804|"~     This is an open-label positron emission tomography/near infrared (PET/NIRF) study to~     investigate the imaging navigation performance and evaluation efficacy of dual modality~     imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of~     40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected~     intravenously before the operation and intraoperative respectively. Visual and~     semiquantitative method will be used to assess the PET images and real-time margins~     localization for surgical navigation.~   "
11184|NCT02910791|"~     Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial~     infections and inflammation. Studies indicate that skin cells from these patients may have~     some changes that make these patients more susceptible to bacterial infections. Inflammatory~     environment may have an effect on the function of skin cells.~      The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts)~     and how they regulate skin barrier function. To study this we need to establish skin cells~     that can be grown in the laboratory. We will use small skin biopsies from patients with~     atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin~     cells have a limited lifetime when grown in laboratory as part of the project we would like~     to modify them, which allows them to grow for long time in the research laboratory. Some of~     the collected skin biopsies and isolated skin cells will be used to examine what gene~     products they make.~   "
11185|NCT02910778|"~     To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced~     vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF)~     measurement before and 10 min after a 20 min forearm ischemia. The area under the~     dose-effect curve (AUC) of different ACh doses will be calculated and compared between~     treatment groups (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time~     points (pre-ischemia vs. post-ischemia).~   "
11186|NCT02910765|"~     effects of methylene blue and ozone O3 therapy effects in early sepsis management , and~     their implications upon outcome~   "
11187|NCT02910752|"~     For acute leukemia patients with early relapse after allogeneic stem cell transplantation,~     the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of~     chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell~     support from the original donor.~   "
11188|NCT02910739|"~     This study consists of Part I and Part II. The purpose of Part I is to compare the plasma~     pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of~     40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that of healthy~     matched controls. A safety and pharmacokinetic analysis will be performed in order to~     support the decision to continue with part II. If a decision to continue with part II is~     made, participants with mild HI will be enrolled to receive a single oral dose of MK-8931~     40mg. If any healthy participants from Part I do not meet the matching criteria for Part II~     additional healthy participants will be enrolled.~   "
11189|NCT02910726|"~     This study is being done in patients that have tumors to find out how well sentinel lymph~     nodes (SLNs) can be found with a special dye called indocyanine green (ICG).~   "
11190|NCT02910700|"~     The goal of this clinical research study is to learn if nivolumab and trametinib (with or~     without dabrafenib) can help to control metastatic melanoma in patients who have a BRAF,~     NRAS, or BRAF-wild-type mutation.~      The safety of these drug combinations will also be studied.~   "
11191|NCT02910687|"~     In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75~     years old or older, were included between September 2009 and June 2010. The purpose of this~     observational study (FINE75+5) is to describe these patients, especially regarding the~     following variables: cardiovascular risk, co-morbidity and frailty, and to assess the~     prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently~     associated with 5-year mortality.~   "
11192|NCT02909855|"~     This study investigates whether there are psychological predictors of parental perception of~     side-effects following vaccination with the child flu vaccine. We will also investigate~     whether the perception of side-effects affects parents' intention to vaccinate their child~     again in the following flu season, as well as whether there are underlying differences in~     parents' cognitive biases between those who do and do not re-vaccinate their child.~   "
11193|NCT02909842|"~     This blinded randomized controlled trial aims to investigate the effect of drinking~     fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against~     influenza.~   "
11194|NCT02909829|"~     Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a~     good range is a difficult task. A primary source for poor glucose control in adolescents is~     skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the~     research towards closed-loop delivery systems to automatically regulate glucose levels.~     Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous~     glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on~     sensor readings. The performance of a closed-loop delivery after a missed bolus may be~     improved if the computer program that calculates the insulin is enhanced with a meal~     detection module. The meal detection module will automatically detect the meal (which had no~     bolus delivered), and signal the delivery of more insulin.~      The aim of this study is to assess the safety and efficacy of a closed-loop delivery with~     and without meal detection module compared to conventional pump therapy in regulating~     post-prandial glycemic levels after omission of a meal bolus.~      The primary hypothesis is that closed-loop delivery with no meal detection module will~     reduce the mean increase in postprandial glucose levels after a missed bolus compared to~     conventional pump therapy.~   "
11195|NCT02910661|"~     The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize~     Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at~     improving medication adherence in adolescent kidney transplant, for use in 'real world'~     clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs~     and preferences of stakeholders (kidney transplant recipients, parents, and healthcare~     professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.~   "
11196|NCT02910648|"~     This research is being done to study the impacts of a computerized learning task on health~     behaviors.~   "
11197|NCT02910635|"~     The primary objective of this study is to assess the corrected QT interval (QTc) effect of~     volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300~     mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy~     adult male and female subjects.~   "
11198|NCT02910622|"~     The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and~     targeted therapies - is currently defined by criteria for population groups and not to an~     individual. These expensive treatments - in financial terms and quality of life - will be~     effective for some and administered unnecessarily for other because there is no predictive~     test of response for a given individual.~      For breast cancer, the usual treatment includes the first surgery and adjuvant therapies~     (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years~     as the occurrence or not of a recurrence or metastases.~      These systemic treatments can also be administered before surgery to reduce the tumor volume~     and secondarily allow less mutilating surgery: it is the principle of treatment neo~     adjuvant. In this case, the efficiency will be evaluated more quickly.~      In practice, a patient with breast cancer suspicion has a biopsy which confirms the~     diagnosis and defined the parameters (hormone receptors, cytological grade, receptor~     monoclonal antibodies ...) that guide to the most appropriate type of treatment.~      Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound~     and MRI.~      At the end of this medication, the evaluation of the response is achieved by radiology and~     surgery.~      Pathological examination evaluates and precise response by the criteria of Chevallier and /~     or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy~     regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is~     derived from the University of Limoges.~      Clinical response and / or histopathological could be compared in a reasonable time (2-6~     months), the results of the oncogramme proposed by Oncomedics whether the efficiency~     obtained in vivo is that predicted by the ex vivo test.~      It is the same in the metastatic setting when there is an available target for biopsy and~     assessment of response.~      The management of ovarian cancer in advanced stages can also benefit from a radiological and~     histopathological evaluation strategy before and after systemic treatment to compare the in~     vivo results with those predicted by ex vivo by Oncomedics.~   "
11199|NCT02910609|"~     The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are~     conservative approach, pharmacological intervention and surgical ligation. There is not any~     randomized-controlled trial that demonstrates the superiority of these approaches in preterm~     infants.~   "
11200|NCT02910596|"~     Compare the effectiveness of bethanechol chloride and early bladder training for prevention~     of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.~   "
11201|NCT02910583|"~     This study is to determine the clinical minimum residual disease (MRD) response with the~     combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic~     lymphocytic leukemia (CLL)/small lymphocytic lymphoma~   "
11202|NCT02910570|"~     This is sub-study to a randomised, double blind, placebo-controlled, parallel group, and~     single-centre trial investigating the effect of liraglutide on body weight and pain in~     overweight or obese patients with knee osteoarthritis (NCT02905864).~      In the parent trial patients will be subjected to a run-in diet intervention phase (week -8~     to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be~     randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to~     dietetic guidance on re-introducing regular foods and a focus on continued motivation to~     engage in a healthy lifestyle.~      This sub-study of the parent trial only involves an additional assessment of skin auto~     fluorescence (AGE concentration) in the preallocation phase and in the main trial phase,~     i.e. from enrollment (defined as signature of informed consent) to treatment allocation~     (visits -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial~     (visits T0 and T15 in the parent trial visit schedule).~   "
11203|NCT02910557|"~     A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC®~     (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic~     Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in~     Treated Patients~   "
11204|NCT02910544|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including~     a low-calorie diet and dietetic counselling, after which.they will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in physical activity associated with the~     initial 8-week weight loss intervention.~   "
11205|NCT02910531|"~     This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney~     stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily~     for three years, while the other half will receive a placebo.~   "
11228|NCT02910232|"~     Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone~     regeneration. In this project we will used our new invention, porous starch- hydroxyapatite~     composite, for in vivo clinical trial.~   "
11206|NCT02910518|"~     Primary Objective:~      To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test~     formulation and insulin glulisine 100 Units/mL reference formulation after a single~     subcutaneous (SC) dose.~      Secondary Objectives:~        -  To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK)~          characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after~          a single SC dose.~        -  To assess safety and tolerability of the test and the reference formulation of insulin~          glulisine.~   "
11207|NCT02910505|"~     Single center study to evaluate the safety and efficacy of an investigational version of the~     Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.~   "
11208|NCT02910492|"~     Single-center study to evaluate the safety and efficacy of an investigational version of the~     enlighten™ 670nm laser for photo-rejuvenation.~   "
11209|NCT02910479|"~     E-Celsius device used for measuring the gastrointestinal temperature is composed of an~     ingestible capsule measuring the temperature as well as a transportable module receiving~     data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during~     transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds.~     The main risks related to such devices are related to biocompatibility (in materials used~     for the capsule shell, or level of contamination of the gastrointestinal environment due to~     a defect in the plastic envelope the pill or a lack of hygiene, previously tested in~     clinical trials; see section 10.2).~      It will compare conventional methods of estimating the central temperature continuously with~     gastrointestinal data obtained from the e-Celsius device. The main objective of the research~     is to validate the extent of gastrointestinal temperature obtained from the device under~     test consists of an ingestible electronic capsule and a data reception monitor.~      Secondary objectives will be pursued:~        -  Assess the effects of ingestion of cold drinks on temperature readings taken via~          e-device Celsius, esophageal probe and a rectal probe.~        -  Explore the thermal homogeneity of the digestive tract.~        -  Evaluate the internal memory of the capsule and its data forwarding capacity. This~          protocol will also measure the reliability of the measurement system while comparing it~          to the standards used by health staff today.~   "
11210|NCT02910466|"~     Chronic hypoparathyroidism is a life-long disease for which the chronic administration of~     rhPTH(1-84) is a potential treatment option. The group of subjects in the AAAE0544 core~     study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11~     years. This study is designed to extend this experience and gain knowledge about how safe~     and effective rhPTH(1-84) is in patients with hypoparathyroidism over a long-term duration.~   "
11211|NCT02910453|"~     The standard operative approach to pulmonary lesions has been via postero-lateral~     thoracotomy and direct vision. This technique has some advantages but its morbidity is~     significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to~     reduce the impact on chest wall and the impairment on respiratory mechanic. However, an~     evidence for superiority of the approach minimally invasive is lacking, particularly for the~     difficult assessment of the change in pulmonary function. The aim of this study is to~     compare VATS- over open lobectomy regarding the differences of chest wall kinematic,~     analyzed by optoelectronic plethysmography (OEP).~   "
11212|NCT02910440|"~     The primary objective of this study is to compare the efficacy of DCL-101 to GoLYTELY in~     preparing the large bowel for colonoscopy. Additional secondary objectives will compare the~     safety of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy and compare the~     tolerability of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy.~   "
11213|NCT02910427|"~     Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke~     incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of~     life and neurological deficits remains extraordinary. Stroke incidence and mortality are~     also rising in the developed countries presumably due to a world-wide increase in prevalence~     of obesity and metabolic syndrome. Negative associations have been observed between high~     blood pressure, hyperglycemia and two major dietary cations in vegetables and dairy~     products: potassium and magnesium. Mean levels of dietary potassium and magnesium intake in~     Taiwan are much lower than those of dietary reference intake. Short term supplementation~     studies have demonstrated their effects in reducing blood pressure and degree of insulin~     resistance. However, long-term studies on cardiovascular events are lacking. Our previous~     long-term intervention trial in elderly veteran home showed a 41% reduction in~     cardiovascular mortality by simply switching regular cooking salt to potassium-enriched salt~     in kitchens. The investigators have previously observed an annual reduction of medical cost~     around $ 15,000 NT in the aforementioned veteran home trial. A multi-centered randomized~     controlled trial was carried out with three arms: (1) regular salt (Na salt), (2)~     potassium-enriched salt (K salt), and (3) potassium and magnesium-enriched salt (K/Mg salt).~     The objectives of this study was to investigate whether potassium and magnesium-enriched~     salt would improve the neurological performance of the stroke patients.The investigators~     anticipate to observe beneficial effect from consuming potassium and magnesium enriched salt~     for neurological improvement in stroke patients.~   "
11214|NCT02910414|"~     The TARGET BP I Trial is a randomized, double-blinded, multi-center, international,~     sham-procedure controlled trial, comparing renal denervation performed with the Peregrine~     System Kit in the treatment group to the sham control group (without renal denervation - no~     alcohol infusion). Subjects will be randomized in a 2:1 fashion to treatment versus sham~     control via central randomization.~   "
11215|NCT02910401|"~     Rhinovirus (RV) infections represent the most common cause of asthma exacerbations in~     children and adolescents. The investigators hypothesize that the immune responses generated~     in the nose of allergic rhinitics and asthmatics underlie subsequent systemic modulation of~     the immune system, and that - in susceptible individuals (i.e., those with pre-existing~     asthma) - this modified nasal milieu is responsible for the asthma exacerbation.~      Open label single center study in asthmatics as well as allergic rhinitis (AR) and healthy~     controls. All subjects will undergo good manufacturing practice (GMP) RV16 inoculation and~     responses will be compared between the 3 cohorts.~   "
11216|NCT02910388|"~     To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under~     direct colposcopic Vision.~   "
11252|NCT02909907|"~     To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus~     extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).~   "
11217|NCT02910375|"~     This retrospective multi-centric Belgian prospective trial will involve 10 patients~     initiating or under maintenance subcutaneous golimumab therapy for moderate-to-severe~     colitis at the University Hospitals Leuven (Leuven, Belgium) or AZ Groeninge (Kortrijk,~     Belgium)~      Patients will (have) receive(d) standard induction therapy with golimumab 200mg at week 0,~     and golimumab 100mg at week 2. Maintenance therapy will (have) start(ed) at week 6, with 50~     or 100mg of golimumab every 4 weeks, depending on body weight (50mg every 4 weeks for~     patients with a body weight of less than 80kg, and 100mg for the others)~      Patients will come to the hospital for clinical evaluation, blood sampling and golimumab~     administration following daily clinical practice. The patients will be requested to perform~     several dry blood spot analyses at home.~   "
11218|NCT02910362|"~     This study will measure the dynamic real-time IOP in the anterior chamber during standard~     phacoemulsification surgery.~      What is known:~        -  Fluidics control is determined to be one of the primary drivers of physician decision~          making in choosing phacoemulsification equipment.~        -  Active pressure system fluidic control has a perceived and possibly real (based upon~          recent literature) improvement in intra-cameral IOP stability and reduced pressure~          fluctuations.~        -  Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned~          phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health~          post-operatively.~   "
11219|NCT02910349|"~     Severe aortic regurgitation is a common valvular heart disease with prevalence of~     approximately 1%, affecting rather younger patients. The surgical treatment is the only~     causal treatment; it is recommended in patients with severe symptomatic aortic~     regurgitation. The optimal timing of the surgery is crucial because there is a certain risk~     of perioperative mortality and most patients require lifelong anticoagulation therapy. It is~     widely accepted, that asymptomatic patients with severely dilated left ventricle with~     systolic impairment have worse postoperative prognosis. We aim to evaluate native myocardial~     T1 relaxation time derived from cardiac magnetic resonance and global longitudinal left~     ventricular strain measured by echocardiography. These parameters are related to diffuse~     myocardial fibrosis and we expect to identify the cut off values, which correlate with~     further clinical course. This might enable better timing of the surgical treatment with the~     optimal postoperative left ventricular reverse remodelling and improved patient prognosis.~   "
11220|NCT02910336|"~     Orofacial pain, specially neuropathic orofacial pain, is a challenge of diagnosis and~     treatment in orofacial pain. It is associated with sensory abnormalities.With increasing~     life expectancy of the population is more and more common to find individuals with chronic~     diseases however, there is little evidence about the influence of comorbidities and~     medications in use on sensory thresholds of neuropathic orofacial pain. Objective: to~     investigate the influence of comorbidities and medication in somatosensory function of~     patients with orofacial neuropathic pain compared to controls.In this case-control study,~     336 orofacial pain patients and controls were recruited from the Hospital das Clinicas da~     Faculdade de Medicina da USP were investigated about comorbidities, use of chronic~     medication, pain characteristics and a detailed standardized protocol of somatosensory~     evaluation at the trigeminal territories for cold, warm, tactile, vibration, deep,~     superficial and electric pain thresholds.~   "
11221|NCT02910323|"~     The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia~     is a prospective, multicenter, observational research network for subjects with Cluster~     Headache and/or Trigeminal Neuralgia.~   "
11222|NCT02910310|"~     This study is a prospective, systematic evaluation to assess the effectiveness and safety of~     introduction of UBT into PPH care at secondary level and district hospitals in 3~     low-resource countries. The first component of the evaluation is a prospective stepped wedge~     cluster randomized design to assess the potential reduction in PPH-related mortality and~     invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial~     embolization) for PPH performed at participating facilities following introduction of UBT.~     The second component is a nested cohort analysis to assess the safety and acceptability of~     UBT among women diagnosed with PPH.~   "
11223|NCT02910297|"~     The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of~     Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or~     Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD~     concentration-response characteristics.~   "
11224|NCT02910284|"~     This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and~     immunogenicity of GEN-003 in subjects with genital HSV-2 infection.~   "
11225|NCT02910271|"~     AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in~     asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the~     current recommendations regarding for PAD screening in T1DM.~      METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of~     patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for~     detecting classic symptoms of intermittent claudication, and after verifying the absence of~     symptoms and exclusion criteria, they will be included in the study. All patients will~     undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk~     factors, as well as, an analytical assessment of the lipid profile, HbA1c level,~     proinflammatory profile and oxidative stress status. They will also undergo a comprehensive~     anthropometric assessment including office blood pressure (BP) monitoring and ambulatory~     24-hours BP monitoring in patients with an indication as routine clinical practice,~     assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler~     ultrasound, in the context of routine clinical practice in patients with clinical~     indication, or as an extraordinary procedure for participating in the study in patients who~     do not meet criteria for screening according to current recommendations.~   "
11226|NCT02910258|"~     Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs~     (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly~     α2a) are eligible to this prospective study. Biological and clinical parameters will be~     collected from the beginning of the drug use until last news.~      A non-opposition consent form need to be signed before entering this study.~   "
11524|NCT02906319|"~     The purpose of this study is to determine the association between serum 25-hydroxyvitamin D~     and HbA1c levels in diabetic patients with chronic kidney disease. The investigators~     hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c~     levels.~   "
11229|NCT02910219|"~     Chemotherapy induced diarrhea is seen in up to 40-80% of patients receiving this treatment~     for HER2 positive locally advanced or metastatic breast cancer. This diarrhea can~     significantly impact a patient's quality of life and ability to tolerate chemo/anti-HER2~     therapy. This study will look at the efficacy of the drug crofelemer in preventing diarrhea~     in breast cancer patients.~   "
11230|NCT02910206|"~     Elderly patients have high mortality and postoperative complications rate after surgery,~     especially postoperative cardiac complications. A meta-analysis revealed haemodynamic~     intraoperative events significantly increased the risk of postoperative cardiac~     complications.To limit the risk, optimize the intraoperative management of circulation is~     essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of~     postoperative complications should aimed at choosing the optimal anesthetic drug with~     minimal effect on haemodynamic.So this study is to explore the comparative efficacy and~     safety of anesthetic drug (etomidate or propofol) in elderly patients~   "
11231|NCT02910193|"~     The goal of the multicenter subproject (SP) 10 of the eMED Alcohol Addiction Consortium - A~     Systems-Oriented Approach is to study neuroimaging x genetics predictions in an existing~     sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent~     subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging and~     genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample)~     by examining related MRI-paradigms tagging the same functional brain systems in both samples~     (e.g. reward system, inhibitory control system, emotion processing, working memory); (iii)~     to conduct a follow-up neuroimaging study on the NGFNplus sample validating the~     neurobehavioral risk profiles predictive for juvenile harmful alcohol use in adult patients~     with alcohol addiction, (iv) to expand the NGFNplus sample by including a new set of healthy~     subjects with high genetic risk (1st degree relatives of patients with alcohol addiction).~     The investigators will do so by using elaborate imaging genetic methods that are already~     available and successfully used in other multicenter studies by the investigator's research~     group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic~     scores, network topology) as well as by using complex computational algorithms and~     mathematical models, in particular advanced machine learning methods, developed in SP 6. The~     investigator's approach aims in the long to predict and characterize longitudinal outcomes~     in patients with alcohol addiction (5 years following our index session) and to complement~     the NGFN-sample with an add-on study with 1st degree relatives that will allow the~     investigators to test the generalizability of the identified predictive risk profiles for~     early risk identification.~   "
11232|NCT02910180|"~     This study encompasses the maintenance and utilization of a repository of samples from~     patients with cerebrovascular disease and stroke. The types of tissue taken are blood,~     cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these~     samples can potentially help investigators to better categorize groups of patients,~     understand the underlying etiology of these pathologies, identify markers that are~     associated with favorable or poor outcomes, and track changes that occur during the natural~     course of the disease or with treatment. This is a prospective observational study which~     will use samples from such patients to create this library which can be used to explore~     these questions in the future.~   "
11233|NCT02910167|"~     What AE occur in routine clinical practice, what is the incidence of AE and ADR, how many~     patients present with AE symptoms related to a potential liver injury. What are the drug~     utilization patterns in patients, what are the predisposing factors for the occurrence of~     adverse events and adverse drug reactions.~   "
11234|NCT02910154|"~     Angina is the most common symptom of coronary heart disease among women but unlike men most~     women do not have stenosis of the coronary arteries. In a large proportion of these women,~     coronary microvascular dysfunction (CMD) is thought to be the cause of angina. However, CMD~     is also demonstrable in the asymptomatic population, and may merely be an innocent bystander~     related to the presence of cardiovascular risk factors rather than a cause of angina~     symptoms.~      The aim of this study is to determine whether comprehensive intervention is feasible and~     results in improvement in both angina and microvascular function in these patients.~   "
11235|NCT02910141|"~     This study aims to compare glycaemic control during continuous subcutaneous insulin fusion~     (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to~     identify patient-level characteristics that predict the best improvement in control and any~     change in insulin dose or other outcome.~   "
11236|NCT02910128|"~     This study evaluates the effect of the education innovation programchiquichefs on~     anthropometric variables, quality of life and nutritional habits in an elementary school~     children. Compared with a control group of the same age but in another school.~   "
11237|NCT02910115|"~     The objective of the study is to demonstrate whether cooling the uterine smooth muscle~     during cesarean section (following delivery of the fetus) will promote better uterine~     contraction and involution resulting in lower blood loss, use of fewer uterotonic~     medications, and fewer hysterectomies following cesarean section for dysfunctional labor.~   "
11238|NCT02910102|"~     This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in~     patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease~     Dementia.~   "
11239|NCT02910089|"~     The purpose of this study is to evaluate whether a combination of pharmacist-delivered~     patient engagement techniques improves disease control and medication adherence among~     patients with poorly-controlled diabetes compared with usual care. These engagement~     techniques include shared decision-making and brief negotiated interviewing and are~     delivered telephonically.~   "
11253|NCT02909894|"~     Research shows that sitting for long periods of time on a regular basis is bad for health~     and can leave individuals more susceptible to Obesity, Cardiovascular Disease, Type 2~     Diabetes and premature death regardless of exercise engagement outside of these seated~     hours.~      As sitting is so common in modern society it is vital that research explores ways to protect~     individuals from this worsening issue. Investigators want to see if breaking up long periods~     of sitting time with short, frequent bouts of light physical activity, while remaining~     seated, is enough to alleviate these risk factors.~   "
11525|NCT02906306|"~     The objective of this study is to determine whether individual and/or group occupational~     therapy leads to changes in generalized self-efficacy and psychological well-being, and to~     identify the type of therapy that has the best effects on older adults.~   "
11240|NCT02910076|"~     Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still~     used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been~     recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and~     systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their~     beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve~     balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic~     approach for diabetes. There is need for a better understanding of the mechanisms~     responsible for the improvement of the metabolic response to drug treatment. The~     investigators hypothesize that treatment with a drug improves the function of the beta cell~     and its ability to secrete insulin in response to glucose. The investigators will examine~     the impact of short-term therapy for HCQ in beta cell function in healthy volunteers and in~     patients with type 2 diabetes.~   "
11241|NCT02910063|"~     This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the~     treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR~     after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This~     study incorporates multiple interim analyses for futility, efficacy, and unblinded~     sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared~     to Investigator's Choice chemotherapy.~   "
11242|NCT02910050|"~     This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase~     inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease~     progression after treatment of an aromatase inhibitor.~   "
11243|NCT02910024|"~     The present prospective, randomized, controlled, double-blinded trial investigates the~     effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after~     stroke. Patients with hemipresis will receive either sham or real iTBS over their affected~     hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after~     the intervention phase and three months after enrollment.~   "
11244|NCT02910011|"~     This study will investigate the safety and clinical efficacy of a novel doxycycline topical~     formulation in subjects with Atopic Dermatitis (AD). The investigators hypothesize that~     daily application of the study drug in AD subjects will reduce severity of the disease, by~     reducing skin driven inflammation and restoring skin barrier function. The investigators~     will also monitor the anti-microbial activity of this product on AD skin, as colonization~     with Staph aureus is typically associated with disease severity.~   "
11245|NCT02909998|"~     Use of genotyping for the optimization of treatment with biologics in chronic arthritis by~     looking for an association between certain alleles and response to treatment.~   "
11246|NCT02909985|"~     This pilot study will evaluate the visual response to infrared (IR) in humans after dark~     adaptation. The investigators plan to determine which wavelength and intensity the human eye~     is most sensitive too, using a broad spectrum light source and wavelength-specific bandpass~     filters. The investigators will then evaluate the electrophysiologic response in healthy~     humans to IR, followed by studies in those with specific retinal diseases.~      The long-term goal of this research is to better understand the role that IR plays in visual~     function, and whether this can be manipulated to allow for vision in certain retinal~     pathologies that result from loss of photoreceptor cells. The investigators central~     objective is to test the electrophysiologic response to IR in the dark-adapted retinal and~     visual pathways. The investigators central hypothesis is that IR evokes a visual response in~     humans after dark adaptation, and the characteristics of this response suggest transient~     receptor potential (TRP) channel involvement. The investigators rationale is that a better~     understanding of how IR impacts vision may allow for an alternative mechanism for vision in~     a number of diseases that cause blindness from the degradation or loss of function of~     photoreceptor cells. The investigators will test the investigators hypothesis with the~     following Aims:~      Aim 1: To determine the optimal IR wavelength for visual perception in dark-adapted human~     participants. The investigators hypothesize that the healthy human eye will detect IR~     irradiation, with a maximum sensitivity at a specific wavelength. Using a broad-spectrum~     light source with wavelength-specific bandpass filters, the spectral range of visual~     perception to IR will be evaluated. The same will be done on colorblind participants.~      Aim 2: To test the electrophysiologic response to IR in healthy humans after dark~     adaptation. The investigators hypothesize that IR will elicit an amplitude change on~     electroretinography (ERG) and visual evoked potential (VEP) responses after dark adaptation~     in healthy human participants. Participants will be tested with both test modalities to~     evaluate their response to IR.~      Aim 3: To test the electrophysiologic response to IR after dark adaptation in humans with~     certain retinal diseases. Participants with retinitis pigmentosa, age related macular~     degeneration and congenital stationary night blindness, will be tested. Results will be~     compared to baselines and to those of healthy participants. The investigators hypothesize~     that there will be a response to IR on ERG and VEP, which will provide clues to the retinal~     cell layer location of the response to IR and the nature of potential TRP channel~     involvement.~   "
11247|NCT02909972|"~     Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study~     designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and~     anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced~     myelodysplastic syndrome with wild-type (WT) TP53.~   "
11248|NCT02909959|"~     The aim of this randomized controlled trial is to determine if a nutritional supplement~     containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in~     reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the~     safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its~     effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such~     as hyperactivity, irritability, and repetitive movements.~   "
11249|NCT02909946|"~     Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence~     rates surpassing those in hospitals. The aim of the study is to design and evaluate the~     effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH~     residents. The intervention will incorporate resident-level, environmental, and caregiver~     based strategies. Using a cluster-randomized study design, three NHs will be randomized to~     the intervention group and three to the control group. Control NHs will be allowed to~     continue standard infection prevention practices. Nursing homes will serve as the unit of~     allocation. Analyses will be performed both at the resident and the cluster level. The~     primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO~     acquisition .~   "
11250|NCT02909933|"~     Weight reduction is the most important treatment target when polycystic ovary syndrome~     (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an~     anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.~      We investigates short term interventions with low dose liraglutide in combination with~     metformin and high dose liraglutide alone influence on significant weight reduction in obese~     women with PCOS.~   "
11251|NCT02909920|"~     Shoulder pain is a common and high prevalence in the general population. Subacromial~     Syndrome (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients~     suffering pain, muscle weakness and loss of movement in the affected joint. Initial~     treatment of the SIS is predominantly conservative. Surgical option has high success rates~     and is often used when conservative strategy fails. Traditional Physiotherapy and~     Postoperative exercises is needed to the recovery of joint range, muscle strength, stability~     and functionality. This Research evaluates the feasibility and effectiveness of a~     telerehabilitatión Program in SIS after surgery compared with traditional therapy.~   "
11254|NCT02909881|"~     PhytoSpherix (Phx) is an all-natural, edible polysaccharide extracted from sweet corn. This~     carbohydrate is the major muscle fuel for intense exercise and its stores are quite small~     such that one can run out of it during a single exercise bout. Therefore, Phx should provide~     significant exercise fuel if consumed during exercise. As a result its intake could enhance~     intense exercise performance by providing additional fuel. This experiment Will investigate~     the effects of 4 different dosages of Phx consumed throughout a prolonged exercise bout on~     carbohydrate and fat utilization as well as its oxidation rate and perception of effort~     during prolonged intense exercise in trained cyclists. Muscle and liver carbohydrate stores~     will be examined using a non-invasive ultrasound technique.~   "
11255|NCT02909868|"~     The position of the RV lead may have an important role in the effectiveness of the~     Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag~     from which RV signals (QRS) are identified.~      The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.~   "
11256|NCT02909816|"~     The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric~     Dental Patients. The investigators performed a multicenter observational study. The~     investigators included patients aged 1 to 18 years and who have already failed dental care~     because of non-cooperation; they could be with mental or cognitive disabilities and could~     have sedative premedication. The investigators performed any type of dental care With the~     Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or~     after dental care.~   "
11257|NCT02909803|"~     It is not known whether different lentil varieties have the same efficacy in lowering blood~     glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood~     glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol~     bioactive.~   "
11258|NCT02909790|"~     The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level~     Laser Therapy for circumference reduction of the waistline.~   "
11259|NCT02909777|"~     This research study is evaluating a novel drug called CUDC-907 as a possible treatment for~     resistant (refractory) pediatric solid tumors (including neuroblastoma), lymphoma, or brain~     tumors.~   "
11260|NCT02909764|"~     The goals of the proposed research are to determine whether repeated exposure to a low~     sodium food will result in reduced preference for salt in that food among children; and to~     determine whether such reductions in preference are related to dietary intake of salt, taste~     receptor genotype, and anthropometric and physiological measures.~   "
11261|NCT02909751|"~     The purpose of this study is to investigate whether tocotrienol can improve the effect and~     reduce the side effects of standard chemotherapy before operation for breast cancer.~   "
11262|NCT02909738|"~     The investigators would like to test how well healthy human volunteers power a modified~     oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a~     bicycle instead of wall power so that it can be used in low resource countries where the~     power supply is unreliable.~   "
11263|NCT02909725|"~     Multiple studies have demonstrated a very low prevalence of women meeting physical activity~     and weight gain recommendations during pregnancy. Additionally, previous Blossom Project~     studies have shown that when pregnant women engage in a 20 minute walk each day, they spend~     significantly more time sitting in addition to longer bouts of sitting resulting in~     increased total sedentary time. We are going to test which method works best to decrease~     sitting time, and how those methods effect metabolic parameters such as insulin resistance~     and blood glucose. This study will consist of three groups, each utilizing a commercially~     available fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting~     prolonged sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC):~     will continue on with their normal daily routine; usual care.~   "
11264|NCT02909712|"~     Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for~     use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of~     moderate to high malaria transmission. However, in some locales malaria parasites have lost~     sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP)~     is a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP~     compared to SP amongst pregnant women in Tanzania.~   "
11265|NCT02909699|"~     This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts)~     can improve heart muscle function and ability of arteries to dilate in response to an~     increase in blood flow in adults 65 years of age and older. Additionally, investigators will~     look at how resveratrol can improve functioning of cells (cellular house-keeping) which can~     be related to cardiovascular function.~   "
11266|NCT02909686|"~     The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic~     inflammation that cannot be measured with typical techniques. The investigators will be~     observing the effects of nine different botanical compounds (supplements) that are known to~     suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give~     the investigators information about what is wrong in people with GWI.~   "
11267|NCT02909673|"~     This study is a school-based cluster randomized trial of the 7th grade version of Fourth R,~     a promising teen dating violence prevention program, with 30 ethnically diverse middle~     schools (15 intervention schools, 15 control schools) in one of the nation's largest school~     districts. Students (N = 3,375) will be the unit of analysis and studied prospectively~     (baseline, [post-intervention], and annually for 3 years) to determine the impact of the~     program by comparing students in intervention schools with those in control schools.~   "
11268|NCT02909660|"~     This study evaluates the efficacy and acceptability of two cognitive-behavioural~     interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a~     family accommodation reduction protocol vs. a novel support-seeking protocol. Half of~     participants will be randomly assigned to participate in the support-seeking intervention,~     whereas the other half will participate in the family accommodation reduction intervention.~   "
11340|NCT02908724|"~     The purpose of this study was to assess the progression of cardiac involvement in adult~     patients with Fabry Disease (FD), in the unique Danish Fabry cohort and comparing those FD~     patients receiving primary therapy vs. those that did not.~      The hypothesis is, that we will not be able to see a significant positive difference in~     cardiac involvement in those FD patient who received FD specific therapy vs. those that did~     not.~   "
11269|NCT02909647|"~     Background: Three dimensional (3D) digital pre-operative planning software for~     osteosynthesis of fractures was developed. To assess the usefulness of the 3D planning, we~     evaluated the accuracy of the reduction shapes and selected implants in the patients with~     distal radius fractures.~      Methods: Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis~     using volar locking plates were evaluated. Fifteen wrists were treated with 3D preoperative~     planning as the plan group. The other fifteen wrists were treated with conventional~     preoperative planning as the control group. Volar tilt and radial inclination were measured~     after operation and compared with the healthy side wrist. In addition, preoperative planning~     and postoperative reductions were compared by measuring the volar tilt and radial~     inclination of the 3D images in the plan group. The intra-class correlation coefficient~     (ICC) values of the radiological parameters between healthy side wrists and injured side~     wrists, between preoperative planning and postoperative reductions were evaluated. For the~     accuracy of the implant choices, the ICCs for the screw lengths between the preoperative~     plan and the actual choices were evaluated in the plan group.~   "
11270|NCT02909634|"~     Currently, the number of patients having either permanent or temporary stomas placed is~     increasing each year. Yet, patients with ostomy pouches often struggle with predicting when~     stool output will occur and how to plan around dynamic changes in intestinal activity.~     Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict~     when and how fast such output will occur. In this pilot study the investigators aim to~     gather normative AbStats and Ostom-I data in participants with an ostomy to improve~     prediction of stool output.~      Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve~     prediction of stool output.~      Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of~     AbStats in determining ostomy bag filling as measured by Ostom-I.~   "
11271|NCT02909621|"~     This study is a prospective, randomized, double-blind, placebo-controlled with 3~     parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).~      A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014~     BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the~     dose of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the~     serum levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain~     and on the global patient assessment of disease activity.~      This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific~     biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement~     of the global assessment of the disease by the patient as well as a good tolerance and~     compliance for the treatment. Results of this exploratory study are encouraging and justify~     the setup of a randomized, placebo-controlled double blind and dose-ranging trial.~   "
11272|NCT02909608|"~     Physical activity is an important factor in understanding how diseases can affect a child.~     Decreases in physical activity are sometimes the first thing that happens before a child is~     diagnosed with a disease. When a child sees their doctor, that visit reflects a single point~     in time. It does not capture how a child feels during the days in between visits to their~     doctor. This study plans to use special monitors called actigraphs to collect information~     about physical activity in children with a type of disease called pulmonary hypertension.~     This study will measure how active these children are and compare their activity to clinical~     information and to actigraphy measurements in children without pulmonary hypertension.~   "
11273|NCT02909595|"~     Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the~     preference for basket or balloon catheters for extraction is operator-dependent It is~     reported that complete endoscopic treatment with a single catheter is more likely when~     choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a~     study comparing the two catheter types in patients with periampullary diverticulum has not~     been performed, and there is no strong basis on which to recommend the balloon catheter as a~     first-line stone removal device. The investigators therefore conducted a multicenter~     prospective randomized trial to compare catheter performance in patients with periampullary~     diverticulum.~   "
11274|NCT02909582|"~     Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus~     exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin~     incision placed above the pannus (should a pannus exist).~   "
11275|NCT02909569|"~     This study evaluates the effect of twice daily dose of INCB39110 in the treatment of itch in~     adults.~   "
11276|NCT02909556|"~     Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic~     Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval~     purposes.~   "
11277|NCT02909543|"~     This research will focus on young women between the ages of 18-38 who underwent a heart~     operation and their life experiences. This research will focus on these life events and the~     paradigm of these women being raised as heart sick, and consequently lacking self-esteem~     (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on~     the quality of life compare men and women, completely ignoring women's body image and the~     experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al.,~     2013). This study aims to focus on women's stories about their life experiences and the~     influence of surgery(ies) on their daily life using an the qualitative phenomenological~     approach.~   "
11288|NCT02909400|"~     Mitochondrial Diseases are rare, progressive, multi-system, often-early fatal disorders~     affecting both children and adults. KH176 is a novel chemical entity currently under~     development for the treatment of inherited mitochondrial diseases, including MELAS~     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), MIDD~     (Maternally Inherited Diabetes and Deafness), Leigh's Disease and LHON (Leber's Hereditary~     Optic Neuropathy). The current Proof of Concept study aims to explore the effects of~     treatment with KH176 for 4 weeks on clinical signs and symptoms and biomarkers of~     mitochondrial disease and to evaluate the safety and pharmacokinetics of KH176 in patients~     with m.3242A>G related mitochondrial disease.~   "
11289|NCT02909387|"~     Specific Aim 8. Evaluate the efficacy of Project UPLIFT for reducing symptoms of anxiety,~     depression, and PTSD among African Americans at immediate posttest, after 3 months, and~     after 5 months.~   "
11555|NCT02905916|"~     The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary~     prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.~   "
11278|NCT02909530|"~     Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended~     technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a~     sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic~     masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle~     is usually responsible for the low yield of tissue samples for histopathological~     examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by~     acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge~     needle can maximize tissue acquisition and sample adequacy, which is important for~     appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in~     patients with pancreatic head lesions is significantly lower using the 19-gauge compared to~     the 22-gauge needle. This is attributable to the technical difficulty to push the needle out~     of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the~     head region, it is therefore particularly important to improve technical success in these~     cases. The new 19-gauge biopsy needle Olympus EZ Shot3 Plus is more flexible than common~     biopsy needles such as EZ Shot2 and should therefore provide improved access to regions~     like pancreatic head. The aim of this multicenter prospective randomized crossover study is~     to compare those two needles during EUS-FNB of solid pancreatic masses.~      Therefore this study will enroll 40 patients in five German centers with solid pancreatic~     masses and consecutive indication for EUS-FNB. Both needles will be used in each patient~     following a predetermined random order.~      Primary endpoint is the correct histological diagnosis of the mass assessed by each needle.~     Technical failure is regarded as a negative histological diagnosis.~      Secondary endpoints include a comparison of technical failure using each needle,~     histological quality, duration of procedure and rate of adverse events.~   "
11279|NCT02909517|"~     This prospective, non-therapeutic study will determine whether a novel imaging technique can~     identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.~      In this study, we will modify the standard angiography protocol by having patients return~     twice in the week following angiography for additional photographs. Photographs will be~     obtained 2-7 days after angiography, but without further injection of dye. This technique~     contrasts with normal angiography in which photographs are taken during the transit phase of~     dye circulation and in the minutes thereafter. Of note, both the dye and the cameras used~     for its detection have been approved for clinical use for several decades and are routinely~     used in the evaluation of patients with ocular tumours.~      We will evaluate 5 groups:~        1. Choroidal nevus (low-risk features): requires distinction from melanoma through~          diagnostic testing~        2. Choroidal indeterminate melanocytic lesion (high-risk features): requires diagnostic~          testing for identification and distinction from nevus and melanoma~        3. Choroidal melanoma: requires confirmation of diagnosis and evaluation for potential~          metatstases~        4. Suspected metastatic tumour (ie, primary tumour elsewhere): requires identification of~          primary tumour~        5. Locally treated ocular tumours: requires followup to evaluate response to treatment and~          potential change or repeat therapy~   "
11280|NCT02909504|"~     This study is a 4-month open-label study of lithium in the acute treatment of patients with~     bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and~     titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L. Blood samples~     are collected at baseline and at the end of study. Analyses of 45 molecule expressions in~     mononuclear blood cells at baseline and endpoint will be carried out after the completion of~     study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5~     (DSM-5) criteria for bipolar I or II will be enrolled.~   "
11281|NCT02909491|"~     The primary objective of this study is to determine whether geriatric inpatients with severe~     behavioral disorders exhibit higher serum ionized calcium concentration than geriatric~     inpatients without behavioral disorders, but no difference in serum calcium or corrected~     calcium concentrations. The secondary objective of this study is to determine whether the~     serum ionized calcium concentration is associated with behavioral and cognitive performance~     among geriatric inpatients.~   "
11282|NCT02909478|"~     Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and~     dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced~     nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known~     about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely~     used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However,~     multi-period use of dexamethasone could be associated with side effect, such as~     hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic~     therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone~     plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with~     colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.~   "
11283|NCT02909465|"~     Ketamine is the cornerstone of procedural sedation in emergency department but ketamine~     induced agitation has limited its usage by many physicians. As a solution, some propose~     using midazolam or haloperidol before ketamine injection. In this randomized double blind~     clinical trial, patients who are eligible for sedation by ketamine are allocated in 3~     groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg~     of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of~     ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure~     the clinician's satisfaction with sedation instrument is evaluated after the procedure.~   "
11284|NCT02909452|"~     The objectives of this study are to explore different dosing levels and schedules of~     entinostat in combination with pembrolizumab in patients with advanced solid tumors, in~     terms of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and~     efficacy~   "
11285|NCT02909439|"~     This study will compare patient recovery measures after reversal of neuromuscular blockade~     with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle~     strength, time to extubation and quality of recovery in the post anesthesia care unit.~   "
11286|NCT02909426|"~     Mammography screening has limited performance in young women or women with dense breasts~     although it is the only proven method for breast cancer screening that reduces the~     mortality. The investigators propose a multicenter trial of breast cancer screening to~     assess the effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.~   "
11287|NCT02909413|"~     This study compares desflurane with sevoflurane for school-age children in postoperative~     cognitive function.~   "
11301|NCT02909231|"~     This study evaluates the three, six, and twelve month patient reported outcomes of people~     admitted two trauma centres in western Canada over a four month period. Participants are~     evaluated using the Trauma Outcome Profile and a custom survey instrument.~   "
11302|NCT02909218|"~     The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes,~     affordability, and scalability of offering early antiretroviral treatment to all~     HIV-positive individuals in Swaziland's government-managed health system.~   "
11290|NCT02909374|"~     Fall is one of the most common causes of ill health and morbidity in the older population.~     In Sweden about 300 000 people/year seek emergency treatment due to falls and out of these~     1600 dies. Poor balance control leads to a sedentary life with muscle weakness, fear of~     falling and an increased risk for falls. Balance training and physical activity have~     positive effects on fall prevention and balance, but long-term follow-ups are limited. There~     is also a gap between what has been proven to be efficient in research and what is performed~     in communities and clinical settings.~      Many studies reports on the efficacy of certain treatment, method or training program, which~     often may have taken years to develop, but few of these results are taken further into~     clinical practice and it may take years for them to come into daily use. This delay means~     that there is a gap between what is known and what is consistently done. It if of importance~     implement methods that have been proven to have beneficial impact on health and physical~     function in a clinical trial. Furthermore to evaluate which strategies for implementation~     that are of significance. The aim of this study is to implement evidence based balance~     training into clinical practice to prevent future falls and fall-related injuries in older~     adults.~      The program has been proven to be efficient, but not yet been implemented in the community~     and clinical settings. Implementation outcomes will include effectiveness, acceptability,~     feasibility, fidelity, cost and sustainability. Outcome variables on individual level will~     be fall-related concerns, balance performance, physical function and activity, health~     related quality of life and number of falls.~      The investigators foresee that this balance training for older adults will prevent future~     falls and fall related injuries, increase physical activity level, health related quality of~     life and provide the participants with a strategy to be able to have a physically active and~     healthy life style.~   "
11291|NCT02909361|"~     Fulvestrant 500mg in Patients With Advanced Breast Cancer~   "
11292|NCT02909348|"~     There is a new form of cancer treatment called immunotherapy which does not attack cancer~     directly but works on the immune system to make it more effective. This type of treatment~     may have side effects which are called autoimmune side effects and are caused by the immune~     system attacking the normal parts of the body. At the moment doctors cannot predict which~     patients may be at more risk of developing such autoimmune side effects and doctors also~     cannot predict which patients are more likely to benefit. This study will analyse blood~     samples from patients receiving immunotherapy to see if markers can be identified to help~     make such predictions.~   "
11293|NCT02909335|"~     Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for~     patients undergoing a first liver transplant. This treatment can prevent graft rejection,~     but can cause side effects including kidney failure (in 25% after the first year).~      Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and~     kidney transplant recipients. It preserves renal function when it is started soon after the~     transplant, i.e. before a severe dysfunction is installed.~   "
11294|NCT02909322|"~     The best mode of analgesia delivery after hepatectomy is currently unknown. Many~     institutions routinely use continuous epidural analgesia (CEA) for pain control in this~     patient population. A functioning CEA provides adequate analgesia, but is associated with~     high failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension)~     requiring an increased amount of intravenous fluid and blood products to maintain~     homeostasis. Furthermore, its safety has been the subject of debate in liver resection~     patients due to the elevated risk of epidural hematoma and its serious neurological~     consequences. These limitations highlight the need to explore other options for analgesic~     control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide~     similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis,~     urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared~     to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in~     hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and~     PVB as analgesic techniques after hepatectomy. The investigators propose a randomized~     controlled trial to compare the analgesic efficacy, side effects, and complications~     associated with CEA and PVB in patients undergoing elective hepatectomy through a right~     subcostal incision.~   "
11295|NCT02909309|"~     Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea~     During Sedation With Propofol in TCI Mode~   "
11296|NCT02909296|"~     The pancreatic surgery causing some pancreatic collections. And in a number of case, this~     surgery can require a surgical resumption, a percutaneous drainage or an endoscopic~     drainage.~      The endoscopic care of the treatment of pancreatic collections post-surgery is not yet~     standardized.~      After failure of the medical treatment, the drainage of collections by echo-endoscopy was~     described.~      There are not much series on this specific subject. Only 2 series contain more than 20~     patients with 31 patients for the most important.~      The timing and the technical choice of the endoscopic treatment as well as the long-term~     follow-up are not clear.~      The purpose of this study is to estimate the success and the complications of the endoscopic~     drainage by echo-endoscopy according to the techniques of drainage and the timing of the~     endoscopic treatment.~      The not estimated long-term follow-up will be also considered.~   "
11297|NCT02909283|"~     The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at~     the microcirculatory level in children with sickle cell anemia (SCA) using combined novel~     investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance)~     imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological~     properties.~   "
11298|NCT02909270|"~     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy~     and safety of adhesion barrier Mediclore versus no treatment in patients with total~     thyroidectomy~   "
11299|NCT02909257|"~     Femoral nerve blocks are commonly used to provide pain control for total knee replacement,~     anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic~     concentrations result in motor block of the quadriceps and constitute an inherent risk~     factor for patient fall.~      The aim of this study is to determine the minimum effective concentration of bupivacaine in~     90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the~     femoral nerve.~   "
11300|NCT02909244|"~     Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease,~     mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and~     the TTC7A deficiency.~      This inflammatory bowel disease is frequent but inconstant, raising questions about other~     factors contributing to the disease. The aim of our study is to analyze, describe and~     compare the gut microbiota of patients with those primary immune deficiency, with or without~     intestinal disease.~      The investigators can expect, in the long term, to compare on a same patient, the gut~     microbiota evolution, and to assess the role of gut microbiota modifications on the onset of~     an inflammatory bowel disease.~   "
15105|NCT02859571|"~     This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor~     at term. Half of participants will be taken continuous oxytocin, while the other half will~     be taken intermittent oxytocin.~   "
11303|NCT02909205|"~     The aim of the study is to improve care practice related to gastrostomy management. This a~     before-after study, aimed at evaluating knowledge of care givers, families and patients~     about gastrostomy management. The intervention includes 1) A training in a care protocol for~     hospital care givers, and 2) A booklet for patients, families, and outpatient care givers.~     The evaluation criterion is a questionnaire to assess knowledge of hospital care givers,~     patients, families, and outpatient care givers.~   "
11304|NCT02909192|"~     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of~     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not~     well understood, and treatment options remain limited. The proposed research will examine~     markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the~     project will examine effects of bright light exposure on circadin function, sleep and~     alertness in PD.~   "
11305|NCT02909179|"~     The purpose of this community-based randomized controlled trial is to test whether the~     mCARE-II intervention package, delivered by the existing Government of Bangladesh community~     health workforce, will improve neonatal and perinatal survival in a rural setting in~     northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates~     automated workload scheduling, client prioritization and risk stratification, overdue~     service reminders and demand generation through client side reminder messaging. The~     intervention package focuses on the pregnancy and early postpartum period.~   "
11306|NCT02909166|"~     The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden~     measured with a pacemaker device~   "
11307|NCT02909153|"~     The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration~     (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered~     intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).~     It is an open label, dose escalation study.~   "
11308|NCT02909140|"~     Obtaining appropriate mydriasis prior to cataract surgery is an important variable in~     successful surgery. The current practice includes using topical anticholinergic and~     sympathomimetic agents in the preoperative area prior to cataract surgery, but the pupils~     are sometimes insufficiently dilated and can often need additional mydriasis with~     intracameral agents during cataract surgery. Pre-operative topical mydriatic drops take time~     to take effect, are mildly uncomfortable for the patient, and have a cost to the healthcare~     system. If intracameral mydriasis alone can achieve adequate pupil dilation, perhaps topical~     mydriatics would not be needed. The purpose of this study is to evaluate whether topical~     versus intracameral versus topical + intracameral mydriasis is the optimal way to dilate~     pupils during routine cataract surgery. The results of this study have implications for~     improving the efficiency and reducing time prior to cataract surgery. In addition, it has~     significant potential to reduce the cost associated with cataract surgery if preoperative~     drops can be eliminated.~   "
11309|NCT02909127|"~     There is no dysphagia spesific and patient/parent centered outcome instrument in the~     pediatric population. The purpose of this investigation is to develop the Pediatric version~     of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.~   "
11310|NCT02909114|"~     Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer~   "
11311|NCT02909101|"~     The purpose of this study is to examine the effects of a cognitive training program in~     persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine. This study~     tests the feasibility and preliminary efficacy of a computerized cognitive training program~     to improve working memory and decrease impulsivity (delay discounting) among HIV-infected~     individuals.~   "
11312|NCT02909088|"~     The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam~     in reducing stuttering symptoms.~      It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the~     SSI-IV total score, the CGI, SSS and OASES.~   "
11313|NCT02909075|"~     The purpose of this study is to see if a positron emission tomography/computed tomography~     (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the~     thymus size and function. The researchers would like to monitor the thymus with a PET/CT~     scan and a MRI before and after the participants transplantation.~   "
11314|NCT02909062|"~     Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor~     functional activity and provide personal feedback on activity progression. This study aims~     to determine if EAM can provide an objective, assessment of patient functional activity. The~     study will also examine the change in functional activity experienced by patients during the~     first cycle of chemotherapy. Another objective of the study will be to see if baseline~     functional activity and the change in functional activity that occurs during the first cycle~     of chemotherapy can be used to predict patient tolerability of subsequent cycles of~     chemotherapy.~   "
11315|NCT02909049|"~     To assess the effectiveness of two anesthetic techniques by measuring the pain through~     visual analog scale (VAS), to obtain saturation prostate biopsies.~   "
11316|NCT02909036|"~     Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan~     chemotherapy that in packaged in an inactive substance that is believed to help the~     chemotherapy be more stable (meaning that it doesn't lose its effect or need to be~     administered quickly after being mixed). It may also have fewer side effects such as~     problems with important levels of body electrolytes such as potassium, phosphorous and~     magnesium; and cause less kidney and heart damage] than standard formulation melphalan.~      The purpose of this study is to determine if the investigators can achieve a certain level~     of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL~     Amyloidosis.~   "
11317|NCT02909023|"~     Activation of the immune system against a pathogen can be considered one of the most~     effective interventions in the field of infectious diseases.~      Transgene is developing a therapeutic vaccine TG1050 for the treatment of patients with~     chronic and treated Hepatitis B. This biotherapy compound is for the development of T~     cellular immune response in these patients in order to achieve the total elimination of~     infected cells.~      Therefore it is necessary to have measures of ways to assess accurately and reliably the~     presence of such a response in the study subjects.~   "
11370|NCT02908334|"~     In this study patients will be randomized 1:2 to receive either standard of care treatment~     or standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for~     treatment of disseminated and meningeal coccidioidomycosis.~   "
11318|NCT02909010|"~     A randomized, control trial to compare the total dose of sedatives use in patients over 65~     years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus~     monitoring with the exclusive use of sedation scales.~      The study will include all patients over 65 years who enter the intensive care unit of the~     University Hospital of Bellvitge affected with medical or surgical pathology of non~     neurological etiology who require sedation for more than 24 hours to maintain adaptation to~     mechanical ventilation.~   "
11319|NCT02908997|"~     A study to investigate the effectiveness of a reminder tool application at increasing~     performance on memory tasks in people with mild dementia~   "
11320|NCT02908984|"~     In part 1 of the project clinical efficacy of specific neck rehabilitation will be compared~     with standard primary health care among patients with cervicogenic headache and study~     whether fear avoidance beliefs and self-efficacy predict long term neck function and~     headache frequency superior to active range of neck movement. Part 2 will investigate~     whether patients with cervicogenic headache have changes in cerebral grey and white matter~     and in connectivity of the resting state state network, whether these are reversed after~     effective neck rehabilitation, and correlate to symptom severity and degree of disability.~   "
11321|NCT02908971|"~     Background: Children in industrialized and developing countries have a higher tendency to~     present earlier signs of puberty. One hypothesis includes the hormonal effects of~     phytoestrogens found in soy products.~      Objective: to examine the association between consumption of soy-based food in early infancy~     and childhood and the incidence of early or precocious puberty and overweight in school-aged~     children.~      Methods: the study population for this case control study is randomized from a prospectively~     followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk~     allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to~     those who were allergic to milk, and thus consumed only soy based formula and food during~     infancy and childhood (soy group) and a randomized control group who consumed non-soy based~     intake. For both groups data are available of food habits during infancy and collected from~     3 days food diaries during the current study. Physical examination, including weight ,~     height, blood pressure and Tanner Pubertal Staging will performed annually.~   "
11322|NCT02908958|"~     To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the~     treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of~     population of children.~   "
11323|NCT02908945|"~     Monitoring the brain using electroencephalography (EEG) during general anesthesia provides~     the anesthesiologist with valuable feedback of how deeply anesthetized their patient is,~     reducing the chances of under- or overdosing and potentially improving patient outcomes.~     However, commercial EEG monitors that output processed EEG (pEEG) were developed under~     carefully controlled, simple anesthetic regimes - in contrast to the multimodal cocktail~     of drugs often used in clinical practice. Ketamine is one potential adjunct to a standard~     anesthetic, which has a growing body of evidence suggesting that it may improve~     post-operative outcomes. The effects of ketamine on pEEG parameters are poorly understood.~     This randomized, open-label, feasibility study will be undertaken in a sample of 30 adult~     outpatient surgery patients. The primary objective is to observe the intra-operative raw and~     pEEG trends using the NeuroSENSE monitoring system in patients receiving one of two~     different analgesic doses of ketamine, compared to patients not receiving ketamine, during~     an otherwise comparable general anesthetic. Secondarily, we will consider other clinical~     data of interest from both intra- and post-operative contexts in order to establish a~     broader understanding of the potential influence of two analgesic ketamine doses on~     anesthetic depth and post-operative outcomes. Feasibility outcomes will be assessed with the~     ultimate goal of developing a larger-scale clinical trial.~   "
11324|NCT02908932|"~     The goal of this study is to determine if supplementation with krill oil concentrate~     containing the phospholipid-bound omega-3 fatty acids improves performance on specific~     cognitive tests that underlie key elements in U.S. Army Infantry Basic Officer Leaders~     Course (IBOLC) and in Ranger School (Training) at Fort Benning, GA.~   "
11325|NCT02908919|"~     The purpose of this study is to determine optimal time intervals for preparation before~     colonoscopy using different formulas.~   "
11326|NCT02908906|"~     The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for~     JNJ-63723283 in Part 1 and to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s)~     in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC),~     melanoma, renal, bladder, small-cell lung cancer (SCLC), and gastric/esophageal cancer in~     Part 2.~   "
11327|NCT02908893|"~     The investigators design a 6-week messaging campaign aimed at promoting flu vaccination~     among fully insured members of a national payer that participate in a wellness program~     offered by the insurer through a mobile app. Outcomes measured will include uptake in flu~     vaccination rate as measured by the insurer and engagement with the campaign through the~     app.~      The goal of the research is to assess the effectiveness of pervasive computing messaging in~     promoting preventative care treatments such as flu shots. An additional goal is that of~     quantifying the importance of emphasizing incentives to increase efficacy of the messages.~   "
11328|NCT02908880|"~     Research study which tests the safety and effectiveness of a new vascular closure device to~     close the femoral access puncture that is created in patients who require this form of~     access in order to perform the planned procedure. The MANTA device is expected to seal the~     femoral access puncture in less than 1 minute. This may result in less blood loss and a~     shorter time to walking compared to alternative closure means. Use of the MANTA device in~     this study is experimental. All other parts of the procedure involve standard medical care.~   "
11329|NCT02908867|"~     Objectives: To know the main therapeutic strategies used by men with spinal cord injury in~     sexual dysfunctions.~   "
11330|NCT02908854|"~     A two-phase, school-based intervention will be conducted at a high school in Baltimore to~     evaluate whether the addition of spices and herbs to vegetable dishes in the National School~     Lunch Program (NSLP) can increase vegetable intake among students in an urban and~     predominantly African-American high school.~   "
11597|NCT02905357|"~     The Women's HARP study is a multi-center, diagnostic observational study employing~     standardized imaging protocols in women with MINOCA (MI with Non Obstructive Coronary~     Arteries) to determine the underlying diagnosis in each participant. Participants will be~     followed for recurrent clinical events, every 6 months, for a maximum of 3 years.~   "
11331|NCT02908841|"~     Surgicel Snow is an FDA approved topical hemostatic agent for use during surgical~     procedures. Like the other mechanical agents, Surgicel Snow forms a physical barrier that~     blocks blood flow while providing a large surface area for the rapid formation of a fibrin~     clot. As a mechanical agent derived from oxidized regenerated cellulose, Surgicel Snow~     shares with other mechanical hemostatic agents, the benefits of a favorable risk profile.~     This study would examine the efficacy of Surgicel Snow vs. direct compression in the control~     of capillary, venous, and small arterial hemorrhage when ligation or other conventional~     methods of control are impractical or ineffective in patients undergoing laparoscopic or~     robotic assisted laparoscopic hysterectomy. The intraoperative inclusion bleeding~     characteristics are minimal and mild retroperitoneal bleeding and moderate retroperitoneal~     bleeding that has been adequately reduced by standard surgical methods. 60 patients will be~     recruited for this study, all of which will be scheduled for hysterectomy at Western~     Connecticut Health Network (Norwalk Hospital and Danbury Hospital) under the direction of~     Dr. Thomas Rutherford, Dr. John Garofalo, and Dr. Robert Samuelson. The investigators will~     randomize 30 patients to the treatment group and 30 patients to the control group.~     Participants may continue all regular medications before and during the study. The consent~     process will be incorporated into the last pre-operative office visit. The health risks~     associated with use of Surgicel Snow may be less, the same or more than direct pressure~     alone. Surgicel Snow is generally used for minimal to mild bleeding from specific or~     widespread area; however, its effectiveness compared to direct pressure is unknown for a~     hysterectomy surgery.~   "
11332|NCT02908828|"~     Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton~     species in the marine food web in the Norwegian Sea. Copepods constitute the largest~     renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now~     developed knowledge and technology for sustainable harvesting of this new resource. The~     purpose of this study is to investigate whether Calanus copepod oil supplementation has an~     equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in~     mice.~   "
11333|NCT02908815|"~     The main objective of this study is to investigate the effects of repetitive Transcranial~     Magnetic Stimulation (rTMS) treatment on patients with probable early or moderate~     Alzheimer's disease.~   "
11334|NCT02908802|"~     Subjects will answer the following questionnaire and tests:~        -  Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)~        -  Demographic Questionnaire - composed by the researchers~        -  Family Eating Habits Questionnaire (FEAHQ-33)~        -  Food Frequency Questionnaire (FFQ)~        -  Test MOXO~      The subjects will take the study product for six months.~      After six months the subject will fill once again all the questionnaires.~   "
11335|NCT02908789|"~     This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in~     deep carious lesions. This is an in vivo study approved at the Research Ethics Committee,~     which will be conducted in 30 patients between 3 and 12 years. Patients included in the~     study should have at least one primary molar or permanent with deep active caries limited~     occlusal / proximal surfaces involving beyond the inner half of dentin. The investigators~     will considered from exclusion criteria children whose parents refuse to sign the informed~     consent document; children who do not cooperate with the clinical examination/treatment;~     children with syndromes or chronic systemic diseases; teeth with painful symptoms consistent~     with irreversible pulpitis or mobility; periodontal changes; roots with pathological~     resorption; cases of primary teeth roots in advanced stage of physiological resorption and~     patients that have made the use of any antibiotics during the study period or within three~     months prior to its beginning. The treatments will be carried out after local anesthesia and~     isolation of the operative field with a rubber dam. The removal of carious dentin surface~     demineralized necrotic and not subject to remineralization will be held with drill at low~     rpm under cooling with sterile saline. The removal of decayed tissue will start by the side~     walls and later on the pulp wall. After this time the intervention with aPDT using 0.01%~     methylene blue as photosensitizer will be held. Finally, the cavity is restored with~     adhesive and composite resin system. The dentin samples will be collected with the help of~     spoon sterile dentine in two stages: C1 after digging and C2 after aPDT. The microbiological~     analyzes will be conducted with counting of colony forming units (CFU / mg of carious~     dentin), blindly from coded samples. The viability of microorganisms will be evaluated in~     the following culture media: Brain Heart Infusion agar for feasibility total microorganisms;~     CHROMagar candida to Candida genus; Mitis Salaviarius agar with addition of bacitracin 0.2~     U/mL, sucrose and glucose to Streptococcus mutans; Mitis Salivarius agar to total~     Streptococcus; Rogosa Agar to Lactobacillus spp. and enterococcosel for Enterococcus genus.~     The reproducibility of the counting method will be verified between triplicates.~     Microbiological data will be evaluated with appropriate statistical tests with a level of~     5%. Based on this project is expected to prove the clinical efficacy of aPDT using 0.01%~     methylene blue as an adjunct in reducing of microorganisms from interior of deep carious~     lesions contributing to the clinical and radiographic success.~   "
11336|NCT02908776|"~     MYDA-MI study is a randomized, placebo controlled, double blind study performed in San~     Filippo Neri Hospital, Roma, Italy. The planned study duration is 18 months. The objectives~     are to assess the effects of pre-treatment with probiotic Ecoviesel on the incidence and~     magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable~     patients. 250 patients with chronic stable angina scheduled for a coronary angiography and~     possible ad hoc angioplasty will be randomized to receive pre-treatment with Ecoviesel~     sachets (each sachet contains 200 billions bacteria) or Placebo. The pre-treatment dosage~     will be 4 sachets of probiotic Ecoviesel or placebo for at least 2 weeks before the planned~     procedure. In patients undergoing angioplasty the same treatment will be continued for 4~     weeks after PCI with secondary outcome measures performed at the end of this second stage.~   "
11337|NCT02908763|"~     HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The~     purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg~     loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level~     HBsAg.~   "
11338|NCT02908750|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung~     cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine~     kinase inhibitor (TKI) agent.~      Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of~     fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.~      Continuous Access will allow patients further access to osimertinib after the PK phase (Part~     A). All patients from Part A who completed treatment may continue to receive osimertinib 80~     mg once daily until: they are no longer deriving clinical benefit; or any other reason.~   "
11339|NCT02908737|"~     The clinical study is designed to evaluate the safety and effectiveness of recipient~     controlled Bass and Treble.~   "
15901|NCT02849275|"~     The EPOCH-1 research intervention aims to examine the effects of a fermented dairy beverage~     consumption on changes in behavioral and biological measures of cognition and stress among~     obese adults.~   "
11341|NCT02908711|"~     Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal~     analgesia, including peripheral nerve block, is recommended for post-operative pain relief~     1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after~     surgery2.~      This is a prospective, randomized control trial designed to compare the analgesic efficacy~     of the adductor canal block (ACB) performed immediately before or immediately after primary~     total knee arthroplasty (TKA). The primary objective of this study is to measure pain score~     associated with knee motion following TKA among patients receiving ACB as part of their~     analgesic regimen for TKA. Secondary end points include assessment of postoperative~     ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction~     between the two analgesic approaches. The investigators hypothesize that ACB before the~     surgery will reduce a patient's postoperative pain and improve patient satisfaction.~      All consecutive patients undergoing primary TKA will be recruited for enrollment in the~     study. Patients will be for randomized preoperatively to receive either preemptive ABC~     (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will~     receive the block prior to incision. Patients randomized to the PostACB group will receive~     the block at the end of the surgery. Both techniques are in accordance to the standard of~     care at our institute. All patients will have the ACB done by a regional anesthesiologist in~     the regional anesthesia unit, or in the operating room. Patient medical history will be~     obtained and blocks will be placed per usual protocol. Operative and anesthetic details,~     including medications given, will be recorded.~      Pain scores and pain medications given in the PACU will be recorded. Supplementary~     analgesics will be provided per institutional PACU protocol. Study data will be recorded for~     up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the~     orthopedic follow-up appointment to evaluate the patient's late pain scores and overall~     satisfaction. Data will be analyzed both at the conclusion of the study and at several~     intervals prior to completion of the study.~   "
11342|NCT02908698|"~     Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by~     itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of~     children and 2-10% of adults being affected. The lesions of atopic dermatitis patients are~     very inflamed, with an increased number of inflammatory cells in the skin. The first line~     treatment for AD is steroids, which reduce inflammation in the skin. There are several ways~     to measure if the treatment is effective, including clinical and cellular. We are proposing~     that a controlled skin allergen challenge will be an effective way to measure the effect of~     steroid at a cellular level through the measurement of inflammatory cells in the late~     cutaneous response. This will be examined using a placebo-controlled trial.~   "
11343|NCT02908685|"~     Multi-center, randomized, double-blind, placebo-controlled, Phase II study to assess the~     safety, tolerability, pharmacokinetic, pharmacodynamics, and efficacy of RO7034067 in adult~     and pediatric patients with Type 2 and Type 3 spinal muscular atrophy (SMA). The study~     consists of two parts, an exploratory dose finding part (Part 1) of RO7034067 for 12-weeks~     and a confirmatory part (Part 2) of RO7034067 for 24-months.~   "
11344|NCT02908672|"~     This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study~     designed to evaluate the efficacy, safety, and pharmacokinetics of combination of~     atezolizumab (ATZ), cobimetinib and vemurafenib compared with combination of ATZ placebo,~     cobimetinib and vemurafenib in participants with previously untreated BRAFv600~     mutation-positive metastatic or unresectable locally advanced melanoma.~   "
11345|NCT02908659|"~     In ICU setting, a large number of medical devices are attached to patients, generating~     numerous alarm signals. Several studies have demonstrated that most of these alarms are not~     clinically relevant and tend to lower the attentiveness of healthcare professional and, in~     turn, lower patient safety.The aim of the study is to assess the relevance of respiratory~     rate alarm on a monitoring device in non-ventilated ICU patients.~      The investigator primary hypothesis is that this alarm is potentially useless. If this~     hypothesis is confirmed, a second interventional trial will be conducted on the impact of~     this alarm removal.~   "
11346|NCT02908646|"~     Both of microcoil localization and hookwire localization have been proved as good~     preoperative CT(computed tomography)-guided techniques to guide VATS resection for the~     diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the~     diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine~     if microcoil localization for pulmonary nodules can be safer than hookwire localization~   "
11347|NCT02908633|"~     It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty:~     ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat~     Glaucoma and Cataract. It is a Randomised, Prospective Study.~   "
11348|NCT02908620|"~     The purpose of this study is to determine if the topical application to cheek tissue of the~     combination of benzocaine and tetracaine has a longer duration of local anesthetic activity~     than benzocaine alone.~   "
11349|NCT02908607|"~     When screening results for cervical premalignant lesions are positive, colposcopy is~     recommended. This is highly sensitive screening method. However, specificity of the test is~     of low.~      Thus, a technology that improves the accuracy of the colposcopic exam is needed.~      This is a feasibility study with the goal of examining the performance of a thermal imaging~     camera in the detection of cervical malignant and premalignant lesions.~   "
11350|NCT02908594|"~     Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise~     program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal~     disease (ESRD) patients receiving haemodialysis, and further determine the effect of~     mediation through self-efficacy and resilience in patients receiving the IARCEP.~      Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis,~     which negatively affects their QOL. Exercise can mitigate this effect. Patient's~     self-efficacy and resilience may be crucial mediators in exercise.~      Design. This study was a randomised controlled trial. Method. Seventy-six participants were~     randomly assigned to either a control or exercise group. Both groups received routine care;~     whereas the exercise group participated the 3- months IARCEP. Data were collected at~     baseline, the first, second, and third months, over a 14 months in 2013-2014.~   "
11351|NCT02908581|"~     This study will be conducted to observe any change in fungal pattern on skin of arsenicosis~     patients before and after administration of folic acid (5 mg) tablets.~   "
11352|NCT02908568|"~     Study over muscular stretching to reduce pain the oral cavity.~   "
11371|NCT02908321|"~     Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of~     the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a~     way that interferes with their wellbeing and every day functioning. In this project the~     investigators will study the effect of the group program The Cool Kids Anxiety Program:~     Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific~     developed for children with ASD. The investigators expect a decrease in the overall anxiety~     level together with an increase in the ability of handling anxiety.~   "
15902|NCT02849262|"~     The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan~     in patients with external genital warts.~   "
11353|NCT02908555|"~     The purpose of this exploratory study is to evaluate the characteristics of sleep,~     perceptions of barriers and facilitators to adequate sleep, and the associations among sleep~     characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and~     adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a~     quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of~     executive function and continuous glucose monitoring (CGM) as well as a narrative~     qualitative component will be used. Results from this pilot study will be used to provide~     the effect sizes needed for a larger-scale descriptive study and to establish the need for a~     possible sleep-promoting intervention for adolescents with type 1 diabetes. This project is~     consistent with ongoing research focused on developing preventive, behavioral interventions~     for youth with type 1 diabetes and their families to improve physiological (i.e., glycemic~     control) and psychological (i.e., quality of life) outcomes. Sleep promotion may become an~     important component of these interventions. Thus, the following specific aims will be~     addressed:~        1. Describe the objective and subjective characteristics of sleep (duration, continuity,~          bed time/rise times); sleep quality and sleep habits among adolescents with type 1~          diabetes.~        2. Explore the relationship between characteristics of self-reported sleep (i.e., habits,~          duration, daytime sleepiness) and executive function, coping, adherence, and adjustment~          (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.~        3. Explore the relationship of glucose excursions on sleep characteristics and executive~          functioning.~      3. Conduct a qualitative study using narrative analysis with adolescents to identify~     perceived barriers, facilitators, and consequences associated with insufficient sleep in~     adolescents with type 1 diabetes.~   "
11354|NCT02908542|"~     Hypercalcemia, whether chronic or acute, exposes the patient to potentially serious~     complications (arrhythmias, nephrolithiasis, nephrocalcinosis, ...). Prevention relies~     primarily on effective etiological necessary for taking matched load. Under the French~     reference center for rare disorders of calcium and phosphorus, the investigators looked for~     mutations in the coding sequence of the CYP24A1 gene (encoding the enzyme responsible for~     the breakdown of vitamin D), among patients with hypercalcemia without hyperparathyroidism~     with hypersensitivity to vitamin D. However, only 25% of these patients have a genetic~     anomaly suggesting the involvement of other genes (Molin et al. 2015). Recently our team,~     combined with Kaufmann et al. (2014 JCEM) validated the interest of the determination of~     metabolites of vitamin D by liquid chromatography-tandem mass spectrometry (LC-MS / MS), as~     biological pre-screening stage for patients with hypercalcemia.~      The objective of this project is to complement the molecular and biochemical studies of~     patients without mutation of the coding sequence of CYP24A1, in a gene candidate approach~     using massively parallel sequencing (MPS) which allows to study a panel of gene potentially~     involved in disorder of metabolism of calcium and phosphorus. Highlighted variations will be~     tested in silico, and if possible in vitro. The investigators will also use LC-MS / MS to~     evaluate in vivo the effects of these variations on the metabolism of vitamin D, to develop~     a genotype / phenotype correlation.~      The work carried out within the Genetics Department Caen University Hospital in~     collaboration with physicians of the rare disease reference center of the metabolism of~     calcium and phosphorus should identify new genetic mechanisms underlying hypercalcemia. At~     the time of development of personalized medicine, it will adapt the therapy in patients at~     risk for metabolic complications and / or kidney following administration of vitamin D and~     finally to offer genetic counseling.~   "
11355|NCT02908529|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator~     muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA~     compared to normal subjects. Until recently, the search for medicines to activate pharyngeal~     muscles in sleeping humans has been discouraging. However, exciting new animal research has~     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug)~     administered together on OSA phenotype traits and OSA severity during sleep.~   "
11356|NCT02908516|"~     The primary objective of this study is to assess the safety and efficacy of Tranexamic acid~     (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip~     fractures. In addition to assessing blood loss in these patients, complications associated~     with TXA use would be characterized including systemic (pulmonary embolism, deep venous~     thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events,~     need for re-hospitalization or re-operation and 30 day mortality.~   "
11357|NCT02908503|"~     The purpose of this study is to evaluate use of four different vaginal films - two sizes and~     two textures. The vaginal films have no active ingredients or medications. Information will~     be gathered about each film (i.e. ease of insertion, proper placement, opinions about each).~     The results of this study will help investigators determine which type of vaginal film to~     use (and how to write product instructions) for future studies.~   "
11358|NCT02908490|"~     The purpose of this study is to determine whether sildenafil improves parameters of vascular~     function and blood markers involved in development of heart disease in patients with~     rheumatoid arthritis.~   "
11359|NCT02908477|"~     This study is designed for patients with a cancer of the oropharynx (tonsils or base of~     tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six~     weeks of daily radiation therapy. This study investigates a less intense radiation treatment~     following surgery that uses half the dose of radiation given over two weeks rather than six~     weeks. Patients will be randomly assigned to receive the less intense treatment versus the~     traditional treatment by coin flip. Patients are twice as likely to receive the less intense~     treatment during randomization.~   "
11360|NCT02908464|"~     The purpose of this trial is to determine whether using a brain training program in the time~     leading up to as well as after heart surgery will reduce confusion and cognitive loss that~     can occur after surgery.~   "
11361|NCT02908451|"~     This study is to define the safety profile and to determine the maximum tolerated dose (MTD)~     and preliminary efficacy of AbGn-107 administered every 28 days (4 weeks) in patients with~     chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic~     adenocarcinoma.~   "
11362|NCT02908438|"~     The study was designed to investigate the effect of luteal-phase administration of~     gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro~     fertilization-embryo transfer.~   "
11372|NCT02908308|"~     ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C~     after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial,~     TTM at 33°C did not confer a survival benefit or improved neurological function, compared to~     TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and~     early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study~     any differences in mortality, neurological function and quality of life between a target~     temperature of 33°C and standard care avoiding fever.~   "
11373|NCT02908295|"~     Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women~     undergoing myomectomy, both open and laparoscopic approach~   "
11374|NCT02908282|"~     The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in~     reducing Dry Eye Syndrome (DES) symptoms.~   "
16457|NCT02841904|"~     This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic~     of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to~     histopathology results.~   "
11363|NCT02908425|"~     Statins are a class of drugs that are the most commonly prescribed medications in developing~     countries. Statins act on the enzyme HMG-CoA reductase to inhibit its conversion to~     mevalonate, a precursor for cholesterol synthesis. Subsequently statins are prescribed to~     patients with relatively high blood cholesterol levels. However, taking statins does not~     come without side effects. Most notably, the effects of statins on muscle wasting have been~     studied extensively. This includes up-regulation of the ubiquitin proteasome system, muscle~     cell damage and rhabdomyolysis, elevated creatine kinase, and mitochondrial dysfunction. Due~     to the negative side effects of statin therapy, additional therapies are warranted to help~     offset the effects on muscle wasting.~      Loss of muscle mass is a significant concern as it is associated with a reduction in muscle~     strength and power (Ferrando et al., 1996; Creditor, 1993). This condition is observed in~     aging, disease states, and long periods of unloading such as hospital admission and can lead~     to disability, increased falls, loss of independence, and mortality. Subsequently, there is~     a critical need to develop interventions to counteract this loss of muscle mass and~     strength. Exercise is one such intervention, however, in some cases may not be a feasible~     option. For instance, exercise has been demonstrated to exacerbate the muscle side of~     effects of statins. Subjects complain of increased muscle soreness and have elevated~     creatine kinase levels and they also do not want to take statins anymore (Kearns et al.,~     2008; Parker et al., 2012; Sinzinger et al., 2004). Because of this limitation, there is a~     critical need to develop other interventions that can prevent the loss of muscle mass during~     statin use.~   "
11364|NCT02908412|"~     The decision to transfuse or not to transfuse blood products is one of the main issues in~     patients undergoing surgery.~      The standard laboratory method of hemoglobin assessment is time-consuming, gives~     intermittent data, and requires venipuncture which is invasive and painful. In the past~     decade, the use of non-invasive and faster methods, which allow physicians to measure~     hemoglobin levels at the patient's bedside, have become widespread. One of the tools that~     make this possible is Spectrophotometric Hemoglobin.~      However, one of the main concerns regarding this method is its accuracy. Since the accuracy~     of this assessment depends on the extent of perfusion of the organ on which the probe is~     placed, use of digital nerve blocks proposed to increase its accuracy.~      This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the~     accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing~     spinal surgery.~   "
11365|NCT02908399|"~     This is a prospective study of up to 250 participants, from birth to 18 months, who have~     already had a chest x-ray while a patient at the National Institute of Health (NICH) in~     Karachi, Pakistan. Participants will include both males and females as well as all races and~     ethnicities. Participants will have thermal pictures of their chest taken by trained study~     staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained~     radiologists to determine if bacterial pneumonia is present. Results of the thermal image~     will then be compared to the results of the chest x-ray. If additional images of the chest~     or other areas of suspected related infection are available, additional thermal images will~     be taken of the same location within 24 hours of the other image.~   "
11366|NCT02908386|"~     Given the lack of evidence for the benefit of particle therapy in relevant cases, he~     investigators proposed an in silico trial to investigate the dosimetric effect of contour~     changes for OAR as well as tumor during chemoradiation in H&N patients. Photon and~     proton-therapy will be compared based on dosimetric data on 7 time points during treatment~     combined with plan robustness. In that way the investigators will be able to assess and~     compare the optimal timing for replanning for photon and proton therapy.~      A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and~     neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and~     during RT (T1-T7)~   "
11367|NCT02908373|"~     The Réseau QualiSanté (risk management network) hardly works on risk management in nursing~     homes. A model to help nursing homes managers to structure and analyze adverse events has~     been constructed by a working group of health professionals in the Réseau QualiSanté.~     Several questions appeared: is the model able to increase patient safety culture of~     professionals working in nursing homes? How to characterize adverse events in nursing homes?~     How frequent are they? The main objective of this research project EHPAGE is to measure the~     impact of the model to structure and analyze adverse events in nursing homes on the patient~     safety culture of professionals. The project combines quantitative data (questionnaire) and~     qualitative data (interviews).~   "
11368|NCT02908360|"~     The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and~     food allergy) has increased dramatically in industrialized countries over the last 20-30~     years.~      Allergic diseases are present especially in children and young adults, but all age groups~     are affected, with variations across countries and age. To propose new therapies, the~     investigators must first understand the physiopathology.~      Since their discovery the regulatory T cells have continued to be the subject of work to~     understand their role in maintaining immune homeostasis in the human body but also their~     involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or~     fluids and allergic diseases.~      It was identified two broad classes of regulatory T cells:~        -  T cells = natural regulators acquisition of a phenotype and a regulatory function right~          out of the thymus ( CD25 + / CD127 + low / FoxP3 +).~        -  T cells induced regulators = acquisition of a phenotype and a regulatory function on~          the periphery depending on the cytokine micro-environment.~      Phenotypic characterization of these is less obvious and even more so than during the last~     ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).~      A new subpopulation of T cells induced in patients with inflammatory bowel disease recently~     identified have a particular phenotype as bearing the CD4 and CD8 double marking with a~     regulatory phenotype.~      These regulatory T cells are also induced a specific of a commensal intestinal bacterium~     (Faecalibacterium prausnitzii).~      Regarding allergies, it has been widely demonstrated a relationship between changes of the~     intestinal microbiota and the occurrence of allergic diseases.~      The investigators would therefore propose a cross-sectional study, single-center,~     controlled, single blinded to study the role of T cells called double positive induced~     regulators DP8 to compare the frequency and the regulatory function of specific DP8 of~     Faecalibacterium prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to~     control samples.~   "
11369|NCT02908347|"~     This Phase IIa study is designed to assess the safety and tolerability of oral MP1032 in~     patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to~     evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week~     follow up will provide an opportunity to perform a first assessment of oral MP1032's~     clinical efficacy in the treatment of moderate to severe psoriasis.~      The study population will consist of 44 enrolled (40 completed) patients with moderate to~     severe chronic plaque psoriasis. Patients must be able to provide written consent and meet~     all the inclusion criteria and none of the exclusion criteria.~   "
35992|NCT02585895|"~     To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled~     low density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future~     apheresis~   "
11375|NCT02908269|"~     The aim of the study is to describe the safety and immunogenicity of the 2016-2017~     formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults~     18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in~     adults ≥ 65 years of age.~      Primary Observational Objectives~        -  To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in~          children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of~          the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent~          vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the~          immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65~          years of age.~        -  To submit available sera from approximately 90 subjects (30 subjects 3 to < 9 years of~          age and 30 subjects 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine,~          and 30 subjects ≥ 65 years of age who receive Fluzone High-Dose vaccine) to CBER for~          further analysis by the WHO, the CDC, and the FDA to support formulation~          recommendations for subsequent influenza vaccines.~   "
11376|NCT02908256|"~     An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the~     intensive care unit and the mortality rate after a major surgery.~      Different criteria are used to guide the optimal vascular filling of a patient. Among the~     various monitoring for the last twenty years are parameters originating from the respiratory~     variations of the arterial pressure curves and the pulse oximetry.~      On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the~     maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen~     saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index~     (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the~     quotient expressed in % between the pulsed infrared absorption signal and the continuous~     absorption signal.~      It has been demonstrated that the dynamic indexes were better than the static indexes to~     determine the response to the vascular filling. A meta-analysis showed that the dynamic~     changes of the variables derived from the arterial pressure curve of patients under mechanic~     ventilation could predict the vascular filling responsiveness with a high specificity and~     sensibility. The same thing applies to the variables derived from the pulsed oxymetry~     curves.~      Furthermore, monitoring and minimizing, through the vascular filling, the variations of the~     pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk~     surgery allows to reduce the postoperative complications and the hospital length of stay.~     This has not yet been proved for the non invasive parameters (IP and PVI).~      The goal of this study is thus to compare a non invasive strategy (based on PVI) to an~     invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic~     interventions (digestive, gynecologic, urologic), in order to test their equivalence and~     measure their impact in terms of hospital stay.~      This record is linked to the NCT02709252 record and share the same cohort of patients.~   "
11377|NCT02908243|"~     Primary prophylaxis in severe hemophiliacs is defined that prophylaxis therapy starts before~     2 years of age and prior to any clinically evident joint bleeding or after first joint~     bleeding and prior to the onset of joint damage irrespective of age, joints can be kept~     normal or very mildly damaged till teenage or adulthood. Primary prophylaxis has been proved~     to be more beneficial and cause less damage to joint than on-demand therapy. Primary~     prophylaxis is also known to be able to decrease the occurrence of factor VIII inhibitor and~     is the most advanced and useful, cost-effective therapy for hemophilia care. However, it~     requires 2 to 3 injections of factor VIII or IX of 20-50 IU/Kg doses every week, it costs a~     lot of expenses. In the year 2013, we tried hard to discuss with Bureau of National Health~     Insurance (BNHI) and have meeting a couple of time, eventually a guideline of an~     intermediate-dose prophylaxis for severe hemophilia was established and a consensus was~     reached that this prophylactic treatment will be cost effective without increased burden of~     total budget. This guideline was finally approved by BNHI and will be implemented from July~     1st, 2014. In oder to evaluate the efficacy of prophylaxis treatment, patients will be~     arranged to come back to each hemophilia center at least once a year to have investigation~     of doses and annual consumption of clotting factors, frequencies and causes of bleedings,~     especially joint bleedings, joint outcome by studies of hemophilia joint health score~     (HJHS), hemophilia actives list and health-related quality of life. These results will be~     collected and compared between intermediate-dose prophylaxis group of patients and on demand~     treatment group of patients.~      The life span of hemophiliacs has been improved remarkably in recent years due to sufficient~     and adequate treatments, especially prophylaxis treatment, therefore comorbidities in the~     hemophilic population, e.g. hypertension, diabetes, hyperlipidemia and cancer, etc, have~     been found with prevalences close to those in non-hemophilic population. It is worth that~     the prevalence of these comorbidity will also be investigated. In addition, basic data of~     the patients including age, sex, severity, the development of inhibitor and viral infection~     etc will also be collected for analysis.~   "
11378|NCT02908230|"~     The primary aims of this research project are to:~        1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity,~          mental health, and anthropometric outcomes.~        2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing~          healthy family nutrition and physical activity practices, amount of physical activity,~          and BMI.~        3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical~          activity, and anthropometric outcomes.~   "
11379|NCT02908217|"~     Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical~     evaluation is performed using PMR-AS.~      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting~     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale~     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)~     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).~      All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit~     until the end of the study, depending on response to treatment and PMR-AS.~   "
11380|NCT02908204|"~     Tumor is the primary public health problem and the incidence of esophageal cancer showed the~     increasing trend in the past thirty years. According to the statistics in 2015, the new~     onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal~     cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of~     patients in China. With the development of endoscopic technics, more and more patients~     choose to receive the endoscopic procedure rather than traditional surgery. However, the~     long-term efficacy and outcomes of patients with superficial esophageal squamous cell~     carcinoma received different interventions remained unclear. Thus, investigators aim to~     conduct a multi-center retrospective study to investigate the long term outcomes of~     superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and~     surgery.~   "
11381|NCT02908191|"~     This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will~     be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the~     dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers~     are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging~     assessment of ABI-H0731 in non-cirrhotic, CHB patients.~   "
11484|NCT02906839|"~     The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening~     (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on~     recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in~     patients on optimal medical treatment after AF ablation.~   "
37923|NCT02560662|"~     The purpose of this study is to investigate whether a training program with intensified~     physical exercise prior to and after surgery for breast cancer enhances postoperative~     recovery.~   "
11382|NCT02908178|"~     Patients with ductal carcinoma in situ (DCIS) treated with available therapies have~     experienced excellent outcomes and very low mortality rates due to the disease's~     non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be~     treated. As a result, determining strategies to manage DCIS has been identified as a~     research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is~     controversial in general and needs further scrutiny. Our study addresses this evidence gap~     as the investigators propose a retrospective cohort study to investigate the outcome of SLNB~     among DCIS patients. Specifically, the investigators will compare the outcomes, including~     survival outcomes and treatment side effects, among women older than 67 years of age with~     DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The~     investigators have two primary aims in this study: Aim 1: the investigators select our study~     sample using SEER-Medicare database. The investigators will determine associations between~     SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement~     of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim~     2: the investigators will determine associations between SLNB and long-term outcomes,~     including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis,~     subsequent mastectomy as treated recurrence, and lasting side effects, from >9 months~     post-diagnosis to death or the end of this study period.~      Given the nature of our observational study design, the investigators will apply standard~     multivariate analyses and propensity score methodology to reduce the influence from~     confounders. The investigators will control for patient demographics, comorbidities,~     functional status, tumor characteristics, and prior healthcare utilization. Using distance~     to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for~     stage I/II breast cancer, the investigators also plan to conduct instrument variable~     analyses if necessary. Stratifying patients by key DCIS characteristics (including grade,~     comedonecrosis, and tumor size) and their predicted life expectancy (given their age and~     comorbidities), the investigators also hope to identify patient subgroups who may safely~     forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for~     DCIS management.~   "
11383|NCT02908165|"~     The study will be a single-center, randomized Phase II study of conventional TACE in~     combination with sorafenib, given either continuously or sequentially, in patients with~     unresectable HCC. The primary variables will be tumor response (by MR Imaging) and plasma~     VEGF levels, prior to and after cTACE.~   "
11384|NCT02908152|"~     The purpose of this study is to investigate the effects of curcumin supplement on metabolic~     factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes.~     Subjects will participate in 3 month, two group, randomized intervention, where one group~     (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare~     differences in outcomes between the two groups.~   "
11385|NCT02908139|"~     Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device~     in perioperative time after kidney transplantation~   "
11386|NCT02908126|"~     This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females~     undergoing a caesarean section. Two administrations of oxytocin will be tested, after which~     uterine contractility will be assessed.~   "
11387|NCT02908113|"~     We aim to increase our knowledge of the impact of preterm birth on the maturation of the~     visual and auditory systems and on the development of multisensory perception~      Specifically, we aim to evaluate the preterm infants' capabilities of detection and~     discrimination of different visual and auditory stimuli according to gestational age, post~     menstrual age and the duration of the postnatal life.~      A secondary aim is to compare this competencies in preterm and full term control art term~     equivalent age.~      The final aim is to optimize the hospital environment in order to make it correspond to the~     expectations and sensory abilities of very preterm infants.~      Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which~     could accelerate the processes of sensory maturation~   "
11388|NCT02908100|"~     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled,~     parallel-group, dose-ranging study to evaluate the safety and efficacy of GDC-0853 in~     combination with standard of care therapy in participants with moderate to severe active~     systemic lupus erythematosus (SLE).~   "
11389|NCT02908087|"~     The main objective of the trial is to study whether daily treatment with liraglutide~     improves insulin secretion and reduces the requirement of exogenous insulin, and whether~     liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early~     diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.~   "
11390|NCT02908074|"~     This is a 6 months, active treatment, extension study, open to subjects who have completed~     full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging,~     randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese~     subjects with hypogonadotropic hypogonadism [HH]).~      The main purpose of Study MBGS206 is to evaluate bone mineral density and other long term~     safety and efficacy parameters in subjects after 12 months exposure with BGS649, to better~     define the risk/benefit of BGS649 in the obese male HH patient. The study will also collect~     additional BGS649 safety and efficacy data on subjects that were randomised to placebo in~     Study MBGS205 and have 6 months active drug exposure in Study MBGS206.~      The study is planned to enroll approximately 90 patients.~   "
11391|NCT02908061|"~     The purpose of this study is to compare any good and bad effects of using Ultrapro mesh~     along with the usual bladder removal surgery, versus having the usual bladder removal~     surgery without the use of the mesh.~   "
11392|NCT02908048|"~     The study will examine and evaluate the use of extracellular RNA in blood as markers for the~     diagnosis of liver disease or cancer, and as markers for prediction of response to treatment~     or recurrence of cancer after surgery~   "
11393|NCT02908035|"~     This is a prospective, multi-center, randomized, dose escalation study to document the~     effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions~     below the knee in symptomatic patients with critical limb ischemia (CLI).~   "
11394|NCT02908022|"~     The overall aim of the present proposal is to investigate how patients' and clinicians'~     (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction~     correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients~     will be recruited for the study.~   "
11395|NCT02908009|"~     This is a prospective, single-center case control comparison of expression of target genes~     responsible for energy utilization, mitochondrial function and oxidative stress and levels~     of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery~     patients.~   "
11396|NCT02907996|"~     The objectives of this study are to collect and assess data related to safety and~     effectiveness of Sovaldi treatment regimens, per the approved prescribing information for~     Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug~     Safety (MFDS).~   "
12905|NCT02888327|"~     This open-label, four group, fixed-sequence study will evaluate the safety and~     pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and~     probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.~   "
11397|NCT02907983|"~     Hot flashes and night sweats (i.e., vasomotor symptoms, VMS) affect 80% of women during the~     menopausal transition (MT). VMS are associated with decreased quality of life, increased~     depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work~     productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT~     declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety~     concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a~     selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment~     for VMS. SSRIs are an important treatment option for many women, but their use in treating~     VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of~     symptoms following treatment discontinuation. Identifying safe and effective non-hormonal~     treatments for VMS remains a priority in women's health research.~      Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new~     approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are~     part of the sympathetic nervous system. Although SGB is commonly performed to treat~     neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal~     connections between this ganglion and thermoregulatory regions of the brain, specifically~     the insular cortex.~      In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with~     bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for~     women seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms~     underlying SGB effects. Outcomes will include frequency and intensity of hot flashes,~     objectively-measured VMS, mood, quality of life, sleep, and memory performance in 220~     postmenopausal women with 28 or more moderate to very severe hot flashes per week as~     measured by self-report for six months. They will be reassessed at 3 and 6 months following~     the SGB or a sham intervention for objective hot flashes and quality of life measures.~     Mechanistic outcomes (neuroimaging) will be obtained at baseline and 3 months following the~     intervention. Ambulatory monitoring of sympathetic nervous system function (SKNA) will be~     performed at baseline before the procedure, during the procedure and 1 hour following the~     procedure. This will be repeated at 2 and four weeks following the SGB or sham procedure for~     1 hour recordings.~   "
11398|NCT02907970|"~     FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion~     Island and key levers for improvment.~   "
11399|NCT02907957|"~     Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients~     following urological and lower extremity procedures. The injection of local anesthetic into~     the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a~     vasodilation, or increased blood flow, to the lower extremities.~      The purpose of this study is to determine whether the FLIR ONE thermographic camera, a~     smartphone attachment which utilizes an application (app) to measure the temperature at a~     site on an image of the lower extremity, will be able to differentiate between caudal,~     non-caudal, and failed caudal images.~   "
11400|NCT02907944|"~     Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What~     if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use~     disorders (herein refered to as addiction treatments) were routinely provided in HIV~     clinics? Implementation Facilitation is an established strategy to increase the uptake of~     evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation~     on the use of addiction treatments in four large HIV clinics.~      The purpose of the WHAT-IF study is:~      Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to~     identify the site-specific evidence, context and facilitation-related barriers and~     facilitators to the integration of addiction treatments to help tailor an Implementation~     Facilitation for each clinic.~      Aim 2. To evaluate the impact of Implementation Facilitation on:~      2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to~     deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in~     organizational models of care used to deliver addiction treatments~      Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy~     receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients~     eligible for addiction treatment.~   "
11401|NCT02907931|"~     Ultrasound represents an attractive non-invasive method to assess hemodynamic status.~     Understanding dynamic changes in hemodynamics in situations such as hypovolemia, sepsis, and~     cardiogenic shock can potentially help improve patient care. However, the inter-rater~     reliability and accuracy of how various ultrasound measurements reflect dynamic changes in~     physiology remains incompletely understood. Overall our aims are to investigate the use of~     ultrasound in a controlled setting, specifically using lower body negative pressure (LBNP),~     which can simulate hypovolemia at varied levels in human volunteers.~      Aim 1: To determine the change in carotid blood flow (measured by velocity time integral,~     VTI) in subjects undergoing simulated hypovolemia at LBNP levels that precede vital sign~     changes.~      Hypothesis: Carotid VTI will demonstrate significant changes that precede vital sign changes~     in simulated hypovolemia.~      Aim 2: To compare transcranial color Doppler indices of cerebral blood flow with carotid~     blood flow, as assessed by VTI of the common carotid artery.~      Hypothesis: Changes in transcranial color Doppler indices of cerebral blood flow will be~     mirrored by changes in carotid blood flow, indicating carotid VTI is an adequate surrogate~     for measuring cerebral blood flow in variable states of central hypovolemia. However, if~     cerebral blood flow remains more constant than carotid blood flow throughout varying levels~     of hypovolemia, our assumption is that cerebral autoregulation alters the relationship~     between carotid and cerebral blood flow. The more complex procedure of Transcranial Doppler~     ultrasound (TCD) must be performed to obtain valid assessments of cerebral blood flow.~   "
11402|NCT02907918|"~     The investigators propose to influence estrogen receptor (ER) signaling by combining~     endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal~     growth factor receptor 2 (HER2)+ early stage breast cancer.~   "
11403|NCT02907905|"~     Social insecurity is a significant cost in human terms (health and societal), it defines~     evil and can be identified as difficulties accessing health and especially water.~      We chose to take stock of these populations defined by difficulties accessing water as~     precarious setting. Subjects homeless population fall into this by accident of life, a life~     homeless or migrant subjects often illegally having only transitory access (associative or~     charitable structures host) the conditions precarious sanitation including drinking water or~     toilet. Populations of slums in the same conditions or the presence rationed water (one tap~     for 150 people) restricts hygiene.~   "
11404|NCT02907892|"~     A randomized controlled trial to determine whether changing of gloves by the surgical team~     during cesarean section may decrease post-operative infectious morbidity and wound~     complications~   "
11405|NCT02907879|"~     The objective of the study is to assess brain tissue perfusion by ultrasound perfusion~     imaging. Specifically~        -  to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to~          assess specificity and sensitivity, and predictive values for detection of brain tissue~          hypoperfusion leading to infarction~        -  to test whether treatment-effects by induced hypertension, balloon-dilatation, or~          intra-arterial nimodipine infusion can be detected and quantified by UPI~   "
11406|NCT02907866|"~     Endobronchial ultrasound (EBUS) is a technique that uses ultrasound along with bronchoscope~     to visualize airway wall and structures adjacent to it. Pneumothorax is a known complication~     from EBUS procedure. To rule out a Pneumothorax after the procedure, a Chest -X-ray is~     usually done. Point-of-care sonography has emerged as an invaluable tool in the assessment~     of patients with both traumatic and non-traumatic dyspnea. Multiple studies involving~     bedside ultrasound has shown that a pneumothorax can easily be ruled out if pleural sliding~     sign or B lines are visualized on lung ultrasonography; the accuracy of lung ultrasound in~     ruling out pneumothorax approach computed tomography and exceed plain radiography.~     Preforming a lung ultrasound using the EBUS bronchoscope tip as a way to rule out~     pneumothorax has never been described previously. If this is possible it will obviate the~     need of getting a Chest -X-ray and decrease the dose of radiation that the patient is~     exposed to. In this study we will demonstrate that the feasibility of using the transducer~     of the EBUS Bronchoscope to perform bedside lung ultrasound to rule out pneumothorax.~   "
11407|NCT02907853|"~     This study will link findings from neuroscience with clinical outcomes using contingency~     management (CM) to identify changes in brain structure and function that emerge during~     purely behavioral therapy for methamphetamine (MA) use.~   "
11408|NCT02907840|"~     The study will explore the possibility to predict potential for recruitment in acute~     hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2~     (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory~     pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT~     to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data~     on pulmonary gas exchange.~   "
11409|NCT02907827|"~     Patients with locally advanced melanoma are at high risk for recurrence following surgical~     treatment. More patients with stage IV melanoma remain in complete remission following~     systemic therapy. No standards have been established for the surveillance of patients at~     high risk for recurrence. Whole-body diffusion-weighted magnetic resonance imaging and cfDNA~     analysis of blood are innovative imaging and laboratory investigations that may be of~     benefit for early detection of recurrence in this patient population.~   "
11410|NCT02907814|"~     Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It~     uses infrared light to image patient's eyes. Some patients, such as those with an~     inflammatory disease called uveitis or those who have just undergone cataract surgery, have~     intraocular inflammation. This intraocular inflammation commonly manifests as cells that can~     be seen on routine microscopic clinical examination. However, the only currently available~     method to quantify this intraocular inflammation is by manually counting on the microscopic~     clinical examination. The investigators plan to use the OCT machine to image patient's eyes.~     The investigators will then use the images obtained from the OCT to objectively quantify the~     degree of intraocular inflammation.~   "
11411|NCT02907801|"~     Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry~     that interferes with their development. The use of the Perception-Action Approach (P-AA)~     intervention in infants with CMT is supported by a single case report and needs to be~     researched further to determine its efficacy. This study will investigate the immediate~     effects of the P-AA intervention on habitual head deviation from midline, active head~     rotation range of motion, and functional use of both sides of the body in infants with CMT.~      The participants will be 3 infants with CMT, aged birth to 9 months. A randomized,~     nonconcurrent A-B multiple baseline design across subjects will be used. The intervention~     phase will include 5 daily PT sessions, with outcome data collected at the end of each~     session.~      It is hypothesized that improvements on all outcome measures will be documented upon the~     initiation of the P-A Approach intervention, with the most substantial change expected in~     habitual head deviation from midline measured by still photography.~   "
11412|NCT02907788|"~     Airway disease, featuring intense inflammation, is the main cause of morbidity and mortality~     in cystic fibrosis (CF). Mechanisms of CF airway inflammation remain unclear, hampering~     development of better treatments.This time-sensitive ancillary study leverages a unique~     longitudinal cohort of CF infants, assessing the early phase of airway disease. Through the~     use of innovative cell and fluid based tools for in vivo profiling and in vitro testing of~     BALF samples, this translational effort will yield unprecedented insights into mechanisms of~     PMN dysfunction in CF, and assess new paths for early intervention.~   "
11413|NCT02907775|"~     Over 87,000 people have a first stroke in the UK each year; about 70% of victims have~     altered arm function and about 40% are left with a non-functional arm. Spasticity is a~     significant deterrent for recovery of arm function following stroke. One in four patients~     develop spasticity within the first 2 weeks of the stroke and by 12 months 39 % have~     spasticity. The use of oral antispasticity medications like baclofen and tizanidine are~     often restricted due to side effects like sedation, weakness and floppiness. Compliance of~     adults to treatment with oral anti spasticity drugs is only around 50%.~      There are a few exploratory studies on sensory stimulation using Transcutaneous Electrical~     Nerve Stimulation (TENS) in reducing spasticity. Amatya et al reviewed the evidence and~     concluded that there was not sufficient evidence to recommend its routine use. One possible~     explanation for the ineffectiveness of TENS is that it uses a single channel, single~     strength and fixed duration stimulation to which the nervous system may get habituated. We~     have developed Shefstim; a unique miniaturised 64 channel electrical stimulator. Using~     Shefstim we pioneered a technique called Sensory Barrage Stimulation ;rapid simultaneous~     stimulation at multiple sites, in a constantly changing pattern. We hypothesise that this~     approach will significantly reduce habituation compared to single site stimulation, thus~     providing a better treatment for spasticity.~      Objective of the proposed study is to to explore the feasibility of conducting a community~     based randomised cross over trial comparing SBS with TENS for post stroke upper limb the~     spasticity of elbow flexors to optimise the stimulation parameters through quantifying~     objectively the muscular response to two different stimulation protocols.~   "
11414|NCT02907762|"~     The First In Human (FIH) study is a long-term, single center, non-randomized study~     established by Lombard Medical, Inc. to collect on-label data in the clinical setting on~     patients undergoing endovascular repair with IntelliFlex™, the latest generation of the~     Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and~     aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an~     angle between 0° and 90°.~   "
11415|NCT02907749|"~     The aim of this study is to investigate the effects of spironolactone on liver fibrosis~     progression and portal hypertension in patients with compensated cirrhosis. The patients~     were nonrandomized according to the medical conditions determined by the physicians, in 3~     arms (spironolactone start from 40mg once daily and increase every week with a maximum dose~     as 100mg once daily, carvedilol start from 6.25mg once daily and increase to 12.5mg once~     daily in next week if being tolerated, spironolactone in combination with carvedilol:~     spironolactone is added when carvedilol has reached the most tolerated dose). Portal~     pressure gradient by virtual hepatic venous pressure gradients based on enhanced CT, and~     liver elasticity by Fibroscan Medical Device are documented at baseline level and every six~     months after the treatment. Changes in serum fibrosis markers and liver function are~     monitored before and every 3 months after the treatment.~   "
11416|NCT02907736|"~     Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive~     impairment and mortality worldwide despite the development of revascularization therapies~     (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis~     resistance after IV t-PA therapy is frequent especially in case of AIS with proximal~     occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as~     major triggers and structural factors of various forms of thrombosis. NETs are extracellular~     webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden~     in coronary thrombi is positively correlated with the infarct size and negatively correlated~     with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro~     addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs~     could, in consequence, be promising targets for improved thrombolysis in AIS.~      The aim of this study is to assess the impact of NETs composition of thrombi retrieved~     during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical~     outcome and AIS etiologies.~   "
11417|NCT02907723|"~     This pilot study aims to assess a new device designed for an objective measure of sleep~     parameters. The purpose of the device is to assess, in a more simple and precise way, the~     impact of deep brain stimulation on patient's sleep.~   "
11418|NCT02907710|"~     A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal~     carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients~     in each group. One group was treated with Concurrent Chemoradiotherapy combined with~     Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term~     efficacy and the toxic and side effects of these treatments were evaluated. The 1-year,~     3-year, 5-year overall survival and progression-free survival of patients were analyzed. The~     investigators data may provide an alternative option for the treatment of Locoregionally~     advanced nasopharyngeal carcinoma with high efficacy and low toxicity.~   "
11419|NCT02907697|"~     Many people living with HIV use illicit drugs, which leads to worsened health outcomes and~     increased transmission of HIV due to poor adherence to medication regimens. This research~     will develop an intervention targeting medication adherence that is tailored to the unique~     needs of HIV-infected drug users. This research will promote adherence and improve treatment~     outcomes among HIV-infected drug users thereby minimizing the development of drug resistant~     strains of HIV and reducing transmission.~   "
11420|NCT02907684|"~     The purpose of this study is to investigate the cardio-metabolic health effects of consuming~     almond nuts in place of habitual (usual) snack products in adults at moderate risk of~     developing cardiovascular disease~   "
11421|NCT02907671|"~     Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome~     treatment comparing two different injection sites. Single-blind randomized trial.~   "
11422|NCT02907658|"~     Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its~     effective treatment are at high priority in both public health and educational policies.~     School-based preventive interventions facilitate a low-threshold approach for individuals~     with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated~     approaches which target adolescents at high-risk show larger effects than universal~     prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of~     high-school students that is not at-risk. The PROTECT intervention for indicated prevention~     of IUD in school settings was developed based on these preventive strategies.~      Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in~     Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT~     intervention group or b) assessment only control group. The tested intervention consists of~     a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12~     months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary~     outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem~     solving, cognitive restructuring and emotion regulation skills.~      Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for~     psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both~     risk-reduction and strength-promotion (guideline 3), it considers current research and~     epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy~     and is designed as a systemic intervention (guideline 8) at the school-level. It is expected~     that the intervention decreases risk of IUD onset (incidence rate).~   "
11423|NCT02907645|"~     Influenza vaccine is recommended as routine care for all individuals who are at least 6~     months of age and older. Recently, questions about vaccine safety and concerns for side~     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an~     effort to educate patients, public health entities and physicians give informational~     handouts in various forms.~      However, recent publications have found that pro-vaccine messages can have paradoxical~     effects on vaccine intentions, therefore further studies on vaccine related public health~     communication is needed. The purpose of this study is to compare the effectiveness of~     pro-vaccine messages of local data, pro-vaccine messages of national data, and no~     educational message on patient's receipt of the influenza vaccine. These results will help~     to understand the relationship between patient education and the intent to vaccinate and~     receipt of the influenza vaccine as well as to optimize educational information given to~     patients regarding the influenza vaccine.~   "
11519|NCT02906384|"~     This is a prospective, randomized phase-II study observing the memory preservation and~     functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell~     compartment during prophylactic cranial irradiation for small cell lung cancer patients.~   "
11424|NCT02907632|"~     Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants~     that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm~     infants discharged with their mothers in continuous skin to skin contact and strict~     outpatient follow up). For over 20 years, the use of Metoclopramide has been systematic~     among all preterm infants according to the protocols of the Kangaroo Mother Care (KMC)~     Program . The aim of this clinical trial is to evaluate the effectiveness and security of~     metoclopramide to lessen the symptoms of GRE in premature infants that are followed and~     treated in the Ambulatory KMC Program before 40 weeks of gestational age. Design:~     Randomized, double blind trial, controlled with placebo. Eligible Population: Premature~     infants that are followed and treated in the Ambulatory Kangaroo Mother Care Program at~     Hospital Universitario San Ignacio before 40 weeks of gestational age, which systematically~     receive: metoclopramide 0.2 mg per kg, every 8 hours, 15 minutes before every feeding up to~     40 weeks of gestational age, between January 01 2017 and December 31 2017.Outcomes:~     Incidence of regurgitation episodes reported by the parents of the infants, episodes of~     apnea, bronchoaspiration, postprandial irritability, the infant rejects feeding, alteration~     in the postprandial posture and the frequency and severity of adverse effects associated~     with the use of Metoclopramide such as extrapyramidal symptoms and sedation. In the case of~     continuous variables, the mean and median will be compared according to the distribution and~     for nominal variables, a chi squared test or fisher test will be carried out.~      Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent~     will be requested to parents. An independent committee from the work group will be in charge~     of carrying out the follow-up of the safety and progression of the study. A methodological~     expert, a thematic expert, a statistician and an expert in bioethics will constitute the~     committee.~      Financial Disclosure: The study will be funded through the Kangaroo Foundation with the~     collaboration of the  Hospital Universitario San Ignacio, Bogotá, Colombia.~   "
11425|NCT02907619|"~     This study is an open-label extension to protocol B5161002 and will provide an assessment of~     the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing~     of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects~     will be assigned to receive a monthly individualized maximum tolerated dose based on their~     tolerability profile/data from B5161002. This study will not contain a placebo comparator.~     Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams,~     x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength~     testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk~     test and pulmonary function tests) and pharmacokinetic testing.~   "
11426|NCT02907606|"~     This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and~     dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and~     detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.~   "
11427|NCT02907593|"~     This is a phase I/II open-label study to determine the lowest, safe, effective dose of~     budesonide given with calfactant as the vehicle.~   "
11428|NCT02907580|"~     Influenza vaccine is recommended as routine care for all individuals who are at least 6~     months of age and older. Recently, questions about vaccine safety and concerns for side~     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an~     effort to educate parents and patients, public health entities and physicians give~     informational handouts in various forms. However, recent publications have found that~     pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further~     studies on vaccine related public health communication is needed. Few, if any, studies have~     analyzed the relationship between influenza vaccine attitudes and intention with actual~     vaccine receipt in the pediatric population. These results will help to understand the~     relationship between parent's vaccine perception and the intent to vaccinate versus the~     child's receipt of the influenza vaccine, as well as to optimize educational information~     given to families regarding the influenza vaccine.~   "
11429|NCT02907567|"~     This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study~     of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the~     safety and tolerability of oral CT1812, administered for 28 days. This trial may include up~     to 8 qualified investigator sites in Australia.~   "
11430|NCT02907554|"~     Organ donors included in the study are randomized to a control group or an intervention~     group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from~     these patients are transplanted to chronic kidney insufficiency patients. According to the~     pretreatment of the transplant, delayed graft function during the first week was evaluated~     as well as kidney function at different timepoints and mortality during the first year after~     transplantation.~   "
11431|NCT02907541|"~     This study evaluates the use of eLearning of quality improvement methods. Participants who~     use eLearning only, facilitated learning only and a combination of eLearning and facilitated~     learning will complete questionnaires and be interviewed to establish the effect of~     eLearning of quality improvement methods to improve knowledge, change in behaviour and~     impact on healthcare services for better patient care.~   "
11432|NCT02907528|"~     Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium~     phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD +~     βTCP/HA) and EMD alone.~      Material and Methods: 39 patients, presenting at least one mandibular class II furcation~     defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The~     defects were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA~     filling; βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n =~     13) OFD + EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin~     position (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation~     diagnosis were evaluated at baseline, 6 and 12 months.~   "
11433|NCT02907515|"~     The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2~     IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant~     overdentures are proven to be a successful treatment option for older edentulous adults but~     we need to know if the CM-LOC attachment will retain its superiority over the ball~     attachments intraorally regarding the prosthetic complications in single implant retained~     overdenture like in 2 IOD~   "
11434|NCT02907502|"~     To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two~     iso-energetic, young-child formulas with different protein content during the second year of~     life~   "
11435|NCT02907489|"~     The purpose of this study is to determine whether the use of triple antibiotic paste as~     intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will~     reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic~     necrotic teeth.~   "
12906|NCT02888314|"~     The goal of this study to evaluate the association between Pokemon Go and physical activity~     through a survey among Pokemon Go players.~   "
11436|NCT02907476|"~     This randomized controlled trial is designed to test the Vagal-gamma amino-butyric acid~     (GABA) Hypothesis that one of the mechanisms by which yoga-based practices improve mood and~     decrease anxiety is by correcting an autonomic system (ANS) imbalance with too much activity~     in the sympathetic nervous system (SNS) and too little activity in the parasympathetic~     nervous system (PNS). This imbalance is associated with under activity in the GABA system.~     It is hypothesized that yoga-based practices increase activity in the PNS by increasing~     respiratory sinus arrhythmia (RSA), which is associated with increased activity in the GABA~     system and decreased depressive and anxiety symptoms.~   "
11437|NCT02907463|"~     The purpose of this active post-market surveillance study is to confirm that EDWARDS INTUITY~     Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a~     conventional valve in the same setting. Then to describe short term (30 days) and long term~     (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY~     Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of~     Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline,~     discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.~   "
11438|NCT02907450|"~     The TwiCare® device is a removable brace that can be used in orthopedic referred to~     stimulate mandibular growth or in interception / contention.~      The proposed research project will focus initially on assessing the comfort and safety of~     TwiCare® device. The orthopedic efficiency therefore not part of this study.~      The comfort and safety of the brace will be evaluated firstly by the practitioner during the~     visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and~     with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after~     the start of the port of the device, and during the control visit at 11 weeks.~   "
11439|NCT02907437|"~     Current medications have only a limited effect on two core symptoms of schizophrenia,~     negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline~     which has a beneficial effect in various neurological disorders. In the past years, various~     findings from clinical studies showed its potential role for the treatment of these symptoms~     of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on~     treatment for alleviating positive, negative and cognitive symptoms in schizophrenia~     patients.The current study is a single center, double-blind, randomized study that assess~     the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic~     medications, in adult patients suffering from schizophrenia. Patients will be recruited and~     randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of~     treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent~     any gastrointestinal influences of antibiotics administration. Positive and negative~     symptoms , as well as cognitive functions will be assessed before and after treatment.~   "
11440|NCT02907424|"~     In order to make Cambodia independent from importing a product for the treatment and~     prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a~     collaboration for the development of a range of products for the treatment and prevention of~     malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances,~     the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The~     main objective of this sub-study is to test the efficacy of the newly developed RUTF on the~     recovery of children suffering from severe acute malnutrition. As comparison, the current~     treatment of SAM with BP-100 will be used.~   "
11441|NCT02907411|"~     Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen~     years; anecdotally she has been able to significantly reduce lipedema SAT in women with~     Stage 1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema.~     The study will last for one month, for a total of 12 treatments per subject, seven subjects~     total, to see if there is a change in percent body fat percentage over the course of these~     treatments.~   "
11442|NCT02907398|"~     Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in~     the clinical practice setting; 2) collect additional information on the effectiveness, use~     and safety in the commercial setting; and 3) engage physician customers to report the~     collective outcome within a group of properly trained programs that utilize Inspire therapy~     on a regular basis.~   "
11443|NCT02907385|"~     LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over~     the anastomotic line to prevent bowel content leakage until full physiological function is~     restored.~      RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared~     complications in colorectal surgery. The risk of postoperative anastomotic leakage varies~     widely depending on the level of anastomosis while the risk is higher in low anastomosis.~      In order to best demonstrate the benefits of LifeSeal™ in providing staple line~     reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined~     as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.~      STUDY DESIGN: This study is designed as a prospective, multi-center, multinational~     randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of~     this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change~     in overall anastomotic leak rates in subjects undergoing low anterior resection with an~     anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.~      SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of~     post-operative leaks and additional benefits that could be related to the use of LifeSeal™~     Kit such as reducing the severity and improving the outcome of a leak once it has occurred.~     In addition, the study will allow for collection and analysis of additional safety data and~     usability assessment of the device, medical resource utilization, and health related quality~     of life measures.~   "
11444|NCT02907372|"~     This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or~     enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the~     influence of treatments on patients' cognitive functions on a longitudinal basis and~     evaluate the quality of life and the adherence of patients who had or develop cognitive~     disorders.~   "
11626|NCT02904980|"~     The aim of this study was to integrate a gaze training intervention (i.e., quiet eye~     training; QET) that has been shown to improve the throwing and catching skill of children~     with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy)~     that might alleviate the psychosocial influence of these motor skill deficits.~   "
11445|NCT02907359|"~     A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate~     the efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed~     after adequate prior treatment with azacitidine, decitabine, or both. This global study will~     be conducted in approximately 15 countries. Approximately 408 subjects from approximately~     100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine~     (approximately 272 subjects) or Treatment Choice (approximately 136 subjects). The study~     consists of a 14-day screening period, a treatment period, a safety follow-up visit, and a~     long-term follow-up period. The study is expected to last more than 2 years, and the~     duration of individual subject participation will vary. Subjects may continue to receive~     treatment for as long as they continue to benefit.~   "
11446|NCT02907346|"~     The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic~     intervention to increase use of continuous glucose monitors (CGM) in adolescents and young~     adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her~     research team at University of Connecticut School of Medicine (UConn Health). The~     intervention will reinforce patients for wearing CGM and for uploading it and reviewing its~     data. A 6-month pilot trial will be conducted with up to 20 patients receiving the~     intervention. The specific aims are:~   "
11447|NCT02907333|"~     Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 3-6 months~     after the diagnosis with new examinations. The regression rate is based solely on the~     woman's own ability to clear the cervical lesions. The use of condoms has shown a relatively~     good protective effect against Human Papillomavirus (HPV) infection. It has furthermore been~     indicated that condoms increase the regression rate of cervical lesions.~      The hypothesis of this study is that the regression rate of cervical intraepithelial~     neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up~     period of 3-6 months.~   "
11448|NCT02907320|"~     Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial~     pathology that has an important impact on quality of life and represents a significant~     public health concern, due to its very high frequency in all European and American (north~     and south) countries.~      Venous pathology develops when venous pressure is increased and return of blood is impaired~     through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain,~     muscle cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin,~     restless legs, leg tiredness and/or fatigue.~      The aims of this research is to study the effects on microcirculatory activity (activity on~     very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and~     Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive~     technologies will be performed to obtain measurements of microcirculatory parameters in~     standardized and reproducible conditions for all the participants. In addition, will assess,~     in blood samples, the inflammatory biomarkers .~   "
11449|NCT02907307|"~     The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel~     and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal~     tablet in woman with vulvovaginal candidiasis (VVC)~   "
11450|NCT02907294|"~     To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after~     repeated (8 days) single daily oral dose administration in young male and female healthy~     subjects.~   "
11451|NCT02907281|"~     This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome~     measure in patients with relapsing remitting multiple sclerosis (RRMS).~      Approximately 350 RRMS patients, either untreated or treated with an approved MS~     disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or~     neurologic disease are enrolled. No study medications are provided. Patients on~     disease-modifying therapy are treated according to the local prescribing information. For~     each MS patient and each reference subject, the study consists of Screening (up to 1 month),~     Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed~     during Screening.~   "
11452|NCT02907268|"~     A 16-week single-blind, split-face, randomized study. Each patient served as their own~     control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left~     or right side of the face. Patients received intradermal BTXA injections at week 0 and~     intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of~     intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface~     lift while reducing pore size and sebum production, as well as investigate the differences~     in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and~     intramuscular injection methods.~   "
11453|NCT02907255|"~     Patients are at risk of respiratory depression after having surgery. The medications that~     patients are treated with to control their pain can impair their breathing and this can~     progress to respiratory and cardiac arrest and even death. Vital signs assessment on~     surgical wards is usually done every 4 hours and this may be insufficient to identify and~     manage many cases of respiratory depression. The aim of this study is to determine the~     impact on safety and nursing workflow of a respiratory monitoring on two surgical wards by~     measuring safety outcomes. Respiratory depression is a serious complication of pain~     treatment that can lead to patient complications and death. The level of monitoring~     available in hospitals by nursing staff is insufficient to manage this problem. If this new~     monitoring technology works as designed then patient safety can be improved while~     maintaining effective pain therapy.~   "
11454|NCT02907242|"~     The purpose of this study is to evaluate the role of an integrated strategy at selecting~     fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental~     ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.~   "
11455|NCT02907229|"~     This trial is conducted to evaluate the safety and technical effectiveness of using~     NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of~     intracranial aneurysms which are difficult to be cured by conventional surgical or~     endovascular procedures.~   "
11520|NCT02906371|"~     This is a two cohort, open-label, pilot study to describe the efficacy of administration~     timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events~     in pediatric patients with CD19 expressing relapsed and refractory B-cell acute~     lymphoblastic leukemia with high versus low pre-infusion tumor burden following redirected~     autologous T cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).~   "
11456|NCT02907216|"~     The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria,~     tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with~     or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants~     aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since~     2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been~     evaluated during the clinical development of the HRV vaccine, the vaccine differed in~     composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in~     Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study~     will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when~     co-administered with the liquid HRV vaccine~   "
11457|NCT02907190|"~     The objective of this study is to compare the glycemic and insulinemic response elicited by~     ½ cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni,~     rice and corn.~   "
11458|NCT02907177|"~     This clinical study compares the efficacy, safety, and tolerability of therapy with~     ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).~   "
11459|NCT02907164|"~     The investigators are interested in using social norms to motivate people to sign up for a~     100-day exercise challenge and exploring how to make social norms messages more effective.~   "
11460|NCT02907151|"~     To assess the value of a dedicated knowledge questionnaire, filled by the patient prior~     consultation. Indeed, it could allow to target specific shortcomings of patients first, and~     help the cardiologist to prioritize the other therapeutic education, targeting specifically~     the information provided.~   "
11461|NCT02907138|"~     The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to~     conventional treatment provided by a physical therapist, for people with perceived~     stress-related symptoms.~      Forty people are to be randomized to either:~        1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per~          week, with the guidance of a physical therapist.~           or~        2. Control - treatment as usual (TAU) in physical therapy.~   "
11462|NCT02907125|"~     SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting~     adolescent health, seeks to evaluate a school based adolescent health promotion intervention~     delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school~     counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India.~     SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER~     trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT)~     was implemented to evaluate the effectiveness and cost-effectiveness of these two models~     compared with the Tarang-Adolescence Education Programme (usual care) implemented by the~     State Government of Bihar.~      The SEHER trial hypothesised that both interventions, compared to the control arm, would~     lead to a greater impact on school climate (school connectedness and relationship with~     teachers and fellow students). In addition, the interventions would increase the knowledge,~     attitude and awareness, and promoting healthy behaviours in youth on reproductive and sexual~     health outcomes, mental health and substance use, and gender related attitudes and violence.~     The SEHER trial also hypothesized that the addition of more resource intensive component~     (the SM arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus~     is that students who will have exposure to the SEHER intervention activities in two academic~     years (Class IX and X) will show greater benefits on the primary, secondary and exploratory~     outcomes than students who have exposure to the SEHER intervention activities in one~     academic year (Class IX).~   "
11463|NCT02907112|"~     Excessive meat consumption, particularly of red and processed meat, is associated with~     increased risk of developing a range of chronic diseases. Meat production also significantly~     contributes to the production of global greenhouse gasses (GHG). Given the predicted global~     increase in the human population, coupled with the rise in demand for meat within emerging~     economies, it has been suggested that strategies to alter dietary patterns and reduce meat~     intake should be devised. With the provision of appropriate non- or reduced-meat~     alternatives, this study aims to investigate whether free living subjects can significantly~     reduce their meat intake, and whether such dietary changes positively impact on a range of~     health measures~   "
11464|NCT02907099|"~     The goal of this clinical research study is to learn about the effectiveness, safety, and~     tolerability of pembrolizumab in combination with BL-8040 when given to patients with~     advanced pancreatic cancer.~   "
11465|NCT02907086|"~     Observational study to allow the collection of blood and medical information to evaluate the~     role of circulating tumor material in patients with colorectal cancer and melanoma~   "
11466|NCT02907073|"~     The goal of this proposal is to perform first-in-man evaluation of and experimental imaging~     agent F-18 tetrafluoroborate (BF4) or (TFB).~   "
11467|NCT02907060|"~     A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies~     (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th~     degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of~     oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all~     pregnancies are prolonged.~      A Cochrane review on induction of labour showed that a policy of labour induction at or~     beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French~     College of Obstetricians and Gynaecologists stated, induction of labour can be proposed to~     patients between 41+0 and 41+6 weeks of gestation. In cases where labour is induced and~     cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include~     pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double~     balloon) methods. Those two methods were compared in the PROBAAT trial among women with term~     pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were~     identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical~     ripening was mechanical.~      Considering pharmacological cervical ripening is associated with more uterine hyper~     stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile~     foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are~     associated with a risk of FHR anomalies and that cervical ripening with a pharmacological~     method is another factor which increases this risk: women with prolonged pregnancies could~     benefit from a more gentle cervical ripening.~      At present, no particular method is recommended in cases of cervical ripening and prolonged~     pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical~     ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more~     appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.~   "
11468|NCT02907047|"~     The purpose of this study is to correlate functional outcomes and perioperative~     complications with tourniquet use during total knee arthroplasty.~   "
11469|NCT02907034|"~     Financials constraints of health systems require suitable indices and criteria to better~     allocate resources in order to enhance and maximize social welfare. Among multiple methods,~     the quality-adjusted life year (QALY) is used as a validated and preference-base measure for~     health care procedures in health economics studies such as cost-utility analyses.~      In France, the methodological guide of the public agency of the High Authority for Health~     (HAS) recommends the valuation of health states with the use of a generic and descriptive~     instrument (EQ5D), validated by the Time Trade Off method (TTO) in samples from general~     French population.~      Although it appears to be legitimate to distribute collective resources based on general~     population preferences, a major concern is that individuals do not face a real choice that~     can have a direct implication on their welfare and their life.~      The existence of a discrepancy between revealed hypothetical preferences and real~     preferences would raise the problem concerning production of the currently available~     standards and norms. Hence, a methodological deepening of these preferences revelation~     process is necessary.~      Virtual reality (VR) could play a key role in resolving this methodological problem. Widely~     used in the field of health (such as therapy, medical training...), VR is a simulation that~     seeks to approach the reality, without trying to be quite like it. It aims one or more~     individuals to explore a sensorimotor and cognitive activity in an artificial world in 3D,~     which can be imaginary, symbolic or a simulation of some aspects of the real world (Fuchs,~     2006). VR could be well applied to the field of health economics by offering hypothetical~     scenarios of the different health states from the EQ5D that individuals might experience in~     the first person.~      To date, existence of this discrepancy between revealed hypothetical preferences and~     actual preferences of individuals from the general population is extremely difficult to~     explore. However, this is an important methodological challenge in the revelation of~     preferences to guide health-related decisions.~      Indeed, comparing the revealed preferences about health states established from a first~     person experience in VR to the revealed preferences established from the classic narrative~     approach without VR, may provide an accurate approach of actual and real preferences of~     individuals from the general population.~      Moreover, another advantage of VR is to permit the assessment of a greater number of health~     states, this method being faster processed than the narrative approach: individuals are~     experimenting immediate experience of a situation when under VR. Thus, VR method may~     overcome technical constraints of the classic narrative approach concerning limited sample~     sizes in norms production.~      To the investigators knowledge, VR has never been proposed for valuating health conditions.~      This study would report the relevance and interest in using VR (immersive and immediate life~     situation experience) for the production of utility EQ5D health states values in the general~     population by the revelation of preferences method called the Time Trade Off (TTO), the~     currently approach recommended by the HAS.~      Using VR could circumvent some limitations of the current narrative approach: it would~     provide a better feasibility and acceptability among subjects, fewer inconsistencies, an~     easier and wider access to disadvantaged individuals. Eventually revisions of available~     standards could be proposed to allow the HAS and policy makers to base their choices on more~     reliable, standardized and accurate classifications of health states conditions, that~     associate each health state to a predefined value.~   "
11521|NCT02906358|"~     The purpose of this study is to conduct a parallel group, randomized trial of primary care~     clinic-based and community-based programs to educate and support low-income, Hispanic~     patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.~   "
11470|NCT02907021|"~     Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can~     cause injury to the heart, and this is one of the main reasons it cannot be administered as~     planned. Heart injury can often be successfully treated using cardiac medications. The aim~     of SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with~     mild or moderate cardiac injury, while treating them with appropriate cardiac medications.~     In this way the investigators hope to be able to optimise the delivery of a treatment to~     patients with breast cancer that has proven survival benefits, especially when administered~     for a full 12-month course.~   "
11471|NCT02907008|"~     The aim of the study is to evaluate the impact of sleep quality on intubation rate in~     intensive care units patients with acute respiratory failure~   "
11472|NCT02906995|"~     The purpose of the study is to compare two different dosage forms from which nicotine is~     released and absorbed into the bloodstream.~   "
11473|NCT02906982|"~     The purpose of this study is to evaluate the efficacy of a novel gum health formulation,~     when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical~     improvements in periodontal diseases.~   "
11474|NCT02906969|"~     Background:~      The investigators assessed the use of a colonoscopy instructional video to improve both~     bowel preparation and education prior to procedure. Preceding studies have been vague,~     pinning patient education via diagrams and text as both pivotal and useless for compliance~     in bowel preparations. These studies however lacked assessment of comprehension prior to~     procedure.~      Methodology:~      This is a prospective study of diverse, inner city outpatient university center, first time~     colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction.~     Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation,~     pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same~     spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30~     days of the colonoscopy on demographics, and 14 test questions about colonoscopy and~     preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of~     preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right,~     mid and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).~   "
11475|NCT02906956|"~     The purpose of this study is to explore whether adherence to upper extremity home programs~     changes when persons post stroke practice with preferred music.~   "
11476|NCT02906943|"~     Substantial progress has been made in the treatment of cancer through the use of targeted~     therapies, but what works for one patient might not work for another patient. Certain drugs~     are now being developed that target specific molecules in the body that are believed to be~     part of the disease.~      Biomarkers are specific characteristics of the cancer that may help provide prognostic~     information (e.g. how well patients will be regardless of the treatments given) or help~     predict sensitivity or resistance to a specific treatment.~      The study will collect archival tumor samples (previously collected biopsy or surgical tumor~     samples) to provide biomarker data about a patient's cancer, which may help their physicians~     to identify which clinical trials of new drug treatments may be most appropriate for the~     patient in the future and may also guide the use of approved treatments that may potentially~     benefit the patient.~      Another goal of this study is to develop a province-wide registry of targeted gene~     sequencing testing results that will be made available to cancer researchers. Additional~     tumour tissue and blood samples collected from all study participants will also be stored in~     a biobank at the Ontario Institute for Cancer Research for future research.~      The study will also look at linking data from this study to other health care databases to~     further collect information about the health care the patients received, including medical~     tests, clinic visits, or procedures both before and after participating in this study.~     Having more information about patient health to relate to the DNA sequences may provide new~     insights into cancer and its treatment.~   "
11477|NCT02906930|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and~     safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated~     with diet and exercise only.~   "
11478|NCT02906917|"~     Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine~     plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or~     without oral antidiabetic treatment in need of treatment intensification.~   "
11479|NCT02906904|"~     Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are~     frequent and disabling sleep disorders characterized by arousal specifically from slow wave~     sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state.~     The investigators recently reported frequent subjective complaints of chronic pain, migraine~     and headache during wakefulness in adult sleepwalkers. They also described frequent~     analgesia during severe and injuring episodes, suggesting a relationship between dissociated~     brain activity and nociceptive dysregulation. However, this study did not included objective~     nociceptive measures and the retrospective assessment of perceived pain during parasomnia~     episodes over a lifetime span might also introduce a recall bias.~      The aims of the present study are to measure objective pain sensitivity in patients with~     NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep~     and SWS, and 3) wakefulness.~      Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be~     recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory~     stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic~     stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine~     the nociceptive threshold. During the recovery sleep following the sleep deprivation, the~     investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS~     and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive~     responses.~      The investigators hypothesized a lower nociceptive threshold during wakefulness in~     sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This~     study may help to better understand the etiology and mechanisms underlying the clinical~     enigma of the nociceptive dysregulation in NREM sleep parasomnias.~   "
11480|NCT02906891|"~     A single center pilot study assessing the Vigilant Diabetes Management Companion for the~     prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.~   "
11481|NCT02906878|"~     PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion~   "
11482|NCT02906865|"~     Proximal hamstring rupture is a rare injury, which may be immediately diagnosed.~      In 1996, Sallay showed that functional results of surgical repair were better than those of~     conservative treatment. Surgery is now the rule. The main aim of this study is to obtain a~     more detailed and quantified description of the postoperative outcomes.~   "
11483|NCT02906852|"~     The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis~     compared with standard tissue biopsy analysis for detection of genomic alterations in~     patients with advanced lung cancer.~   "
11522|NCT02906345|"~     Therapeutic plasma exchange (TPE) should used for patients with septic shock in a~     controlled, prospective study focusing on the organ functions of the patients.~   "
11485|NCT02906826|"~     An airway clearance technique (ACT) is one of the core treatments for children with chronic~     lung diseases who are unable to clear their secretions effectively. Unfortunately adherence~     to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there~     has been no way to objectively measure adherence to an ACT. With new technology, it is now~     feasible to connect an electronic manometer to an airway clearance device to objectively~     measure how often the child is actually performing their ACT. The first part of this~     proposed study is to objectively measure adherence against reported adherence over a 4 month~     period. During the second 4 months a video game will be added to the digital manometer which~     only operates if participants are performing their ACT properly. Adherence will again be~     measured.~   "
11486|NCT02906813|"~     The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram~     (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of~     food on the BA of TAK-935 300 mg tablets in healthy adult participants.~   "
11487|NCT02906800|"~     Introduction: Patients with primary unresectable advanced head and neck squamous cell~     carcinomas (HNSCC) have a poor prognosis with a median survival of 22 months (Hauswald H~     Radiat Oncol 2011). They are usually treated with induction chemotherapy followed by~     radiochemotherapy or platinum-based concomitant radiochemotherapy. Most patients achieve an~     objective clinical response contrasting with a high rate of local recurrence and distant~     metastases in the year following radiochemotherapy (Argiris A Ann Oncol 2011). Improvement~     of the efficacy of chemotherapy remains therefore a major clinical goal for this group of~     patients. During the past years, the investigators demonstrated that some conventional~     chemotherapeutics (anthracycline, oxaliplatin…) induce a type of immunogenic cell death~     (ICD) characterized by the exposure of calreticulin on the tumor cell surface, the secretion~     of ATP and the release of high-mobility group box 1 (HMGB1) resulting in activation of tumor~     immunity (Galluzzi L Nat Rev Drug Discov 2012). The investigators recently showed that the~     Na/K-ATPase inhibitor, digoxin, favors ICD, when combined with cisplatin, a drug known not~     to induce ICD. In preclinical models, a synergy between cisplatin and digoxin which led to a~     significant therapeutic improvement (Menger L Sci Transl Med 2012) has been observed. This~     effect seems to be mediated by the immune system as the combined therapy induced intratumor~     T cell infiltration producing cytokines (Menger L Sci Transl Med 2012).~      Hypothesis: Based on our preclinical data, the hypothesis is that adding digoxin to the~     conventional cisplatin based induction chemotherapy regimen in unresectable advanced HNSCC~     will increase the efficacy of this therapy via the induction of anti-tumor immunity.~      Objectives:~      Main: the primary objective is to assess the clinical and biological safety of the~     combination of digoxin to cisplatin-based chemotherapy.~      Secondary: The secondary objectives are to investigate biological markers of efficacy by~     analyzing the recruitment of functional T cells in tumour biopsies after treatment with the~     combination of digoxin and chemotherapy.~   "
11488|NCT02906787|"~     The purpose of this research study is to better understand (1) why people gain weight when~     they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking)~     counseling combined with the nicotine patch help people quit smoking and gain less weight.~   "
11489|NCT02906774|"~     This is a proof-of-principle research study designed to determine whether fecal microbiota~     transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract~     of renal transplant patients. The primary goal of this study is to test whether oral gut~     decontamination followed by FMT by enema delivery will result in decolonization of the~     intestinal tract of renal transplant patients shortly after solid organ transplantation,~     thereby preventing difficult to treat post-transplant infections.~   "
11490|NCT02906761|"~     Asthma is characterized by changes in eicosanoids metabolism, especially high production of~     bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent~     studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid~     mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with~     anti-inflammatory properties, in bronchial epithelial cells and lung macrophages of severe~     asthma patients, leading to imbalance between pro-resolving and pro-inflammatory eicosanoids~     production in airways. Such data suggest that aspirin, that induces lipoxins production,~     could restore lipoxins deficit in severe asthma. Interest for aspirin is also supported by~     data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in~     this particular group of patients, aspirin treatment significantly improves nasal symptoms,~     quality of life, asthma and rhinitis scores, and reduces need for hospitalizations, nasal~     surgery and oral steroids use. Potential effect of aspirin in patients with uncontrolled~     asthma without aspirin intolerance, who presented changes in arachidonic acid pathway close~     to those observed in AIA, is not established.~      The aim of the study is to assess whether long term aspirin treatment could improve asthma~     control, compared to placebo, in patients with uncontrolled disease and nasal polyposis,~     whatever their aspirin tolerance level.~   "
11491|NCT02906748|"~     The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH)~     into the circulatory system of the body through the capillaries. But when parathyroid glands~     were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH~     to examine whether the graft functions. So the investigators took the forearm as the aim~     place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively~     fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the~     PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted~     and not-grafted forearm.~   "
11492|NCT02906735|"~     Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of~     alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a~     lack of understanding what changes of alignment of the lower limb causes to the ankle. The~     investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure~     investigated by means of static and dynamic pedography.~   "
11493|NCT02906722|"~     Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by~     Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active~     antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin~     over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.~   "
11494|NCT02906709|"~     This study will examine the efficacy of omarigliptin 25 mg once weekly compared to placebo~     in Japanese patients with T2DM who have inadequate glycemic control on insulin monotherapy~     in addition to diet and exercise therapy. The primary hypothesis of the study is that~     omarigliptin 25 mg once weekly provides greater reduction in hemoglobin A1C (HbA1c) compared~     with placebo as assessed by change from baseline to Week 16 [Phase A (double-blind period)].~   "
11660|NCT02904538|"~     Both perineural and systemic dexamethasone administration allows an increase in analgesic~     duration of regional anesthesia.~      There is a lack of data to determine wich route allows a longer analgesic effect.~      This study aims to determine wether perineural dexamethasone allows a longer analgesic~     duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%)~     for front foot surgery.~   "
11495|NCT02906696|"~     Bosutinib is a type of TKI which is commonly used for the treatment of CP CML. The standard~     dose of bosutinib often causes temporary, but severe, diarrhea which goes away after~     bosutinib is stopped or the dose is lowered.~      The goal of this clinical research study it to learn if a lower dose of bosutinib is as~     effective as the standard dose. Researchers think that by starting with a lower dose of~     bosutinib and slowly increasing the dose (if needed), the likelihood and severity of~     diarrhea and other side effects may be lowered in patients with CP CML.~      To help researchers learn if the lower dose of bosutinib is as effective as the regular~     dose, researchers will test participant's cytogenetic response to the drug. Cytogenetic~     testing looks at how genetic changes to cells (in this study, the BRC-ABL protein and~     Philadelphia chromosome) may affect how the disease may react to the study drug.~   "
11496|NCT02906683|"~     The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female~     patients with stress urinary incontinence.~   "
11497|NCT02906670|"~     This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this~     study is to see if Pan-HER is safe and effective for patients with advanced epithelial~     malignancies without available therapeutic options.~   "
11498|NCT02906657|"~     Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from~     discrepancies between patient's current medications and the drugs prescribed at admission~     (omission, commission, dosing errors….). Consequences of these discrepancies may be mild~     (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes.~     Medication reconciliation is a process of creating the most accurate list of patient's~     current medication in order to decrease discrepancies and eventually ADEs. Information~     technology and electronic health records are of great interest in this process. In France,~     medications dispensed in community pharmacies during the past 4 months are registered in~     patient's electronic pharmaceutical record. The impact of this record together with a~     pharmacist medication reconciliation will be tested in the CONCIPAGE study.~      Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period~     cross-over study. It will estimate the impact of a medication reconciliation, made by a~     pharmacist, using patient pharmaceutical record, on the occurrence of ADEs during the~     hospitalization of patients aged 65 years and over.~      Fifteen hospitals gathering 20 centers (8 geriatric departments, 8 internal medicine~     departments, and 4 orthopedic surgery departments) will participate in the study. An~     equilibrated randomization will be applied to the 20 centers. The recruiting period will~     last for 24 months and will be divided into four 6-month consecutive periods (A, B, C, D).~     During the first 6-month period (period A), 5 centers (1 to 5) will apply one strategy~     (intervention or usual care) while 5 others (6 to 10) will apply the alternative strategy.~     Centers 11 to 20 will not recruit patients during period A. During the next period (period~     B), centers 11 to 15 and 16 to 20 will apply the intervention or the control strategy, while~     centers 1 to 10 will apply a 6-month wash-out period. During period C, centers 1 to 10 will~     apply the alternative strategy as compared to that applied during period A (cross-over~     design), while centers 11 to 20 will apply the 6-month wash-out period. During period D,~     centers 11 to 20 will apply the alternative strategy as compared to that applied during~     period B, while centers 1 to 10 will not recruit patients during period D.~      Description of the intervention During the control period, no intervention will be held. The~     prior to admission medication list will be made as usual by the hospital physician:~     interview of the patient and relatives, prescriptions brought by the patient, call to~     community physicians and pharmacists, hospital medical records, etc. This process will~     result in a medication prescription list at admission.~      During the intervention period, a local hospital pharmacist will independently perform an~     additional (i.e. to that made by the hospital physician) prior to admission medication list,~     using the above-mentioned sources and in addition, with the help of the electronic~     pharmaceutical record. The medical reconciliation in the intervention period consists in the~     comparison of the pharmacist's and physician's prior to admission medication lists. Such a~     reconciliation might lead to a modification of the medication prescription that was made by~     the physician at admission.~      Patient follow-up Patients will be included the day of admission and will be followed-up up~     to 30 days. A study pharmacist will be enrolled and will be in charge of collecting~     follow-up data for all patients. The study pharmacist will visit centers 2, 4, and 7 months~     after the beginning of each period. He/she will study the record of each patient included in~     the study, and will collect all potential biological or clinical abnormalities,~     prescriptions of antidotes and diagnostic imaging, transfer to ICU, death.~      Objectives The primary objective of the study is to assess the impact of medication~     reconciliation by a pharmacist using usual sources plus the electronic pharmaceutical record~     on ADEs occurring in hospital settings.~      The secondary objectives are the following:~        -  To assess severity and preventability of ADEs in both groups.~        -  To assess the distribution of ADEs in both groups.~        -  To compare the 30-day mortality rates observed in the two groups.~        -  In the intervention group only, to assess the rate of intentional (treatment~          modification intended by the physician) and unintentional discrepancies between the~          prior to admission medication list made by the pharmacist and the hospital physician's~          prescription at admission.~        -  In the intervention group only, to assess the rate of discrepancies between the~          hospital prescription at admission and the prescription after medical reconciliation.~        -  To estimate the cost-effectiveness of the intervention.~   "
11499|NCT02906644|"~     This study plans to compare the efficacy of the nicotine patch / lorcaserin combination~     treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking~     behavior and withdrawal symptoms.~   "
11500|NCT02906631|"~     Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with~     significant morbidity and mortality. Approximately 50% of patients with AE require ICU~     admission because of coma, seizures or acute respiratory failure. Determinants of~     neurological prognosis in these patients are not known.~      Objectives:~      Main objective: To identify determinants of outcome in adult patients admitted to the ICU;~     Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis,~     EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU~     with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to~     describe morbidity and mortality associated with AE at 90 days and 1 year following~     diagnosis.~      Methods: prospective observational multicenter study in French ICUs. All patients admitted~     to the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score~     < or =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90~     days will be identified by multivariable logistic regression analysis.~      Duration of study: 30 months (recruitment 18 months, follow-up 12 months).~      Patients: 300 patients~      Endpoints:~        -  Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days~          following onset of abnormal status (GCS < or =13). This score will be determined by~          contacting the patient. A poor outcome will be defined as a mRS >2 at 90 days.~        -  Secondary endpoints: a) neurological findings within 7 days following onset of altered~          mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis)~          within7 days following onset of altered mental status; c) Time between onset of altered~          mental status and completion of diagnostic studies; d)Time between onset of altered~          mental status and start of appropriate specific therapy; e) neurologic outcomes at 1~          year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in~          non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL~          and SF36 scales;~   "
11501|NCT02906618|"~     The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion~     (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this~     study will help to answer the following research questions:~        -  How much LY3039478 gets into the blood stream when given by mouth as a capsule compared~          to when given by an IV~        -  How long it takes the body to remove the study drug~        -  The safety of LY3039478 and any side effects that might be associated with it~      Participation in the study is expected to last up to 7 weeks. There will be screening, a~     single study period, and a follow-up.~   "
11502|NCT02906605|"~     The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with~     apalutamide is improved compared with apalutamide alone for subjects with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
11503|NCT02906592|"~     The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a~     community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the~     Duke Cancer Network, located in the rural, low resource Scotland County community of North~     Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by~     comparing historical and post-GOA service referral patterns and adherence to planned cancer~     therapy. For this study, the investigators will prospectively enroll up to 60 patients who~     have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to~     these 60 patients, the investigators will also conduct retrospective chart reviews on 120~     patients that would be eligible for this study to evaluate past referral patterns. Eligible~     and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center~     alongside their normal clinic appointment. The investigators will assess impact on the~     healthcare system by evaluating referral patterns (i.e., how many, what type of services)~     using the brief GOA data and EHR data. The study value includes the possibility for~     recognition and access to additional health care referrals if needed.~   "
11504|NCT02906579|"~     To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT~     to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.~   "
11505|NCT02906566|"~     There has been increasing evidence for different rates of natural aging in humans and one of~     the best organs to study human aging is skin. Studies have demonstrated anti-aging effects~     of topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or~     vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,~     studies of retinol in humans have largely occurred in white populations and so this study~     aims to focus on skin aging in individuals of East Asian descent as they represent a~     majority of the world population. This study aims to better characterize the molecular basis~     of rejuvenation effects and to potentially discover new topical agents with similar and/or~     more effective preservation of skin youthfulness.~   "
11506|NCT02906553|"~     This study evaluates the role of the Nitric Oxide system in cognition in patients with~     schizophrenia. Participants will be randomised to 2 equal groups and receive either the~     Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several~     cognitive tasks will be assessed.~   "
11507|NCT02906540|"~     To verify the efficacy of transpubic symphysis reset therapy for low back pain, and provide~     support for the clinical application of this treatment.~   "
11523|NCT02906332|"~     This is an open-label, Phase II, single center trial of pembrolizumab (MK-3475),~     lenalidomide and dexamethasone in subjects with high risk Multiple Myeloma (hrMM) post~     high-dose chemotherapy with autologous stem cell transplantation (ASCT).~      Patients with high-risk MM defined as those with one of the following abnormalities who have~     undergone induction therapy followed by single or tandem melphalan -based ASCT will be~     considered eligible.~   "
11508|NCT02906527|"~     The aim of the study is to compare, in real life, the risk benefit (including both major~     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral~     anticoagulants (DOAC) and with anti vitamin K (VKA) in older adults (≥ 75 years) suffering~     from nvAF.~      The study will be conducted in the French Health insurance database (SNIIRAM). Data of octo+~     patients newly treated with an oral anticoagulant (VKA or DOAC) for non valvular atrial~     fibrillation (nv AF) will be collected from the first exposure of the patient to the drug of~     interest during the inclusion period to the end of the follow-up period (at least one year~     of follow-up for each patient).~   "
11509|NCT02906514|"~     Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity~     of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.~      The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective~     than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic~     effect.~   "
11510|NCT02906501|"~     Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as~     augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD)~     and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help~     control behavioral difficulties. While some argue that agents that block dopaminergic~     receptors may have a deleterious cognitive effect, others stress their moderating effects,~     which possibly improve function in all domains, including cognitive functions. Only a few~     studies have examined this topic, with inconclusive results.~      Aim of study: To measure the effect of risperidone treatment on various cognitive functions~     in a population of ADHD diagnosed children and adolescents with normal IQ.~      Design: The study is an observational prospective open label clinical controlled trial. The~     investigators will compare the performance in a battery of cognitive tasks using the Penn~     Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and~     adolescents diagnosed with ADHD, with and without risperidone.~      Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be~     eligible for this study. We will recruit subjects who their psychiatrist is considering~     rispieridone treatment, those who are already treated with risperidone and subjects with~     only stimulants treatment. All pharmacological treatment is supervised and prescribed to~     subjects by their personal psychiatrist unrelated to the study.~      Significance: Better knowledge of the specific cognitive effects of this form of therapy~     will help us guide both clinical decisions, and recommended monitoring in daily clinical~     work.~   "
11511|NCT02906488|"~     The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa~     in patients with Parkinson's disease in actual usage~   "
11512|NCT02906475|"~     The primary objective of this study is to investigate the effectiveness of a standardized~     skin care regimen using a milk lotion once daily and a bathing addendum as needed during the~     first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no~     structured skin care regimen in infants with atopic predisposition. Secondary objectives are~     to investigate the influence of a structured skin care regimen on the development of AD in~     the second year of life and the skin barrier function up to the infants' age of 2 years.~   "
11513|NCT02906462|"~     In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in~     hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey.~     Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French~     hospitals and showed that their conditions of death were not optimal. The 22th April 2005~     French Law precised patient's end of life rights with necessity to refrain from any~     unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial~     process decision when the patient is not conscious. Since then, studies haven't demonstrate~     any improvement and found that palliative strategy in France is much less used than in other~     developed countries.~   "
11514|NCT02906449|"~     The primary purpose of this study is to investigate the effectiveness of a brief~     mindfulness-based intervention for targeting chronic physiological underarousal and~     post-concussive symptoms following a mild head injury (MHI), as self-reported by~     undergraduate university students. For the purposes of this study, MHI is defined (and~     identified) through our demographic questionnaire as a traumatic-based injury to the head -~     Have you ever hit your head with a force sufficient to alter your state of consciousness~     (consistent with the Kay et al., 1993 criteria/definition; American Congress of~     Rehabilitation Medicine - ACRM). The investigators exclude congenital or genetic injuries.~   "
11515|NCT02906436|"~     Only about 15% of the potential candidates for lung donation are considered suitable for~     transplantation. Thus, a strategy that could improve the quality and precision of assessment~     of nonacceptable donor lungs could have a major impact on reducing waiting time and~     mortality while on the list.~      A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and~     colleagues to assess the quality of lungs from a non-heart-beating donor. The method can~     also be used to recondition marginal and nonacceptable donor lungs.~      After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular~     matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit~     received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed~     venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and~     ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular~     resistance (PVR), lung compliance (LC), and biopsy.~   "
11516|NCT02906423|"~     The purpose of this retrospective chart review pilot study is to research the results and~     scores of the QOL questionnaire implemented across Allina Health clinics. This study will~     investigate average QOL scores by clinical population and demographic group, the change in~     scores over time, and the effect of clinical interventions on QOL scores. The results will~     provide insight into QOL trends within different patient populations and provide guidance~     regarding optimal treatment plans so that Allina caregivers can positively impact patients'~     QOL.~   "
11517|NCT02906410|"~     Participants will be asked to select a hypothetical lunch from a menu that features entrees,~     sides, and drinks. Participants will be able to select a maximum of 1 item from each~     category. Following this meal selection, participants will complete a short survey about~     their demographics, their estimates of information about the meal and about recommended~     eating habits.~   "
11518|NCT02906397|"~     To determine the safety and tolerability of galunisertib when combined with Stereotactic~     Body Radiotherapy (SBRT).~   "
11526|NCT02906293|"~     This study seeks to: Assess normal intestinal event rates for healthy subjects, to~     determine the effect of meal size on an individual's intestinal rate, and to determine~     whether there are differences between individuals in the fasting and post-prandial setting.~      The investigators hypothesize the following:~        1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to~          previously documented bowel sound frequency.~        2. There will a uniform increase in intestinal rate in the immediate post-prandial~          setting. There will be direct correlation between maximal and average post-prandial~          intestinal rates and meal size. Likewise, meal size will correlate with time to~          baseline fasting intestinal rate.~        3. Males and those with lower body mass index (BMI) will experience higher maximal and~          average post-prandial intestinal rates and shorter time to baseline fasting levels~          compared to females and those with higher BMI, respectively.~   "
11527|NCT02906280|"~     EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A~     limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure~     adequate histological samples. Although a larger 19 Ga needle can procure histological~     samples as demonstrated by the conventional 19 Ga needle, published data are not existing~     with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed~     for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the~     recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the~     performance of both needle types.~   "
11528|NCT02906267|"~     This study is designed to evaluate the occurrence of gastric insufflation and the critical~     volume of the stomach after three different modes of positive pressure ventilation during~     induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)~   "
11529|NCT02906254|"~     Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be~     responsible for side-effects and selection of resistance. This study demonstrates the safety~     of an early discontinuation of empirical treatments, in carefully selected patients~     presenting with fever of unknown origin.~   "
11530|NCT02906241|"~     This research has the overall goal of increasing rates at which African American and White~     men with prostate cancer make an informed decision to participate in a cancer clinical~     trial.~   "
11531|NCT02906228|"~     The purpose of this study is to investigate possible effects of radio frequency~     electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG~     in the resting state condition, slow EEG potentials, auditory evoked potentials) and~     cognitive performance measures in test of selective attention, divided attention and working~     memory in healthy elderly females (60 - 80 years).~   "
11532|NCT02906215|"~     Many people living with HIV use illicit drugs and require treatment for both HIV and drug~     use, however, many barriers exist which prevent integration of dual care services. This~     study will develop a novel intervention aimed at the provider-level which will combine an~     evidence-based training model with use of mobile technology to improve care coordination~     between providers at HIV clinics and substance use treatment facilities. If proven~     effective, this intervention may be widely disseminated and easily implemented into existing~     clinic structures, thereby improving care coordination among providers and linkage to dual~     treatment for HIV-infected people who use drugs.~   "
11533|NCT02906202|"~     This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 15 subjects~     ≥12 and ≤50 years of age with transfusion-dependent β-thalassemia (TDT), also known as~     β-thalassemia major, who do not have a β0 mutation at both alleles of the hemoglobin β (HBB)~     gene. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell~     transplantation (HSCT) using LentiGlobin BB305 Drug Product.~   "
11534|NCT02906189|"~     The primary objective of the study is to determine the safety of MRI in patients with~     non-MRI conditional pacemakers. The secondary objective is to determine if there are~     clinically relevant parameter changes in the devices.~   "
11535|NCT02906176|"~     A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic~     characteristics of voriconazole in CYP2C19 poor metabolizers~   "
11536|NCT02906163|"~     Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin~     alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC)~     therapy.~      Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with~     advanced EGFR mutant NSCLC taking SoC as compared to SoC alone.~   "
11537|NCT02906150|"~     Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus~     cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC),~     EGFR wild type~   "
11538|NCT02906137|"~     The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were~     receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the~     gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis~     axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to~     reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected~     subjects.This study aims at better understanding the mechanisms involved in this lack of~     mucosal immune restoration.~   "
11539|NCT02906124|"~     To evaluate outcomes of pregnancy in females diagnosed with familial hypercholesterolaemia~     (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the~     age of 12 months~   "
11540|NCT02906111|"~     The purpose of this study is to determine whether the vaginal estriol before vaginal surgery~     for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and~     quality of life.~   "
11541|NCT02906098|"~     This study evaluates behavioral interventions to increase adolescent's motivation for self~     performed periodontal infection control, by means of adequate oral hygiene. Study subjects~     will be allocated to test and control group where the test will be subjected to an~     individually tailored oral health education program, based on cognitive- behavioral theory~     and principles, and the control to standard educational intervention.~   "
11670|NCT02904408|"~     The aim of this study is to determine the benefits of group psychotherapy on quality of life~     for people with hidradenitis suppurativa receiving medical and surgical treatment versus a~     control group (awaiting group) treated with medical and surgical treatment, without~     psychotherapy.~   "
11542|NCT02906085|"~     One third of migraine patients experience aura, i.e. dramatic, transient neurological~     symptoms, most often in the form of visual disturbances, that usually appear before the~     onset of migraine headache. The likely underlying mechanism of aura is known as cortical~     spreading depression, a wave of changes in electrical activity that slowly spreads in the~     outermost layer of the brain. It is currently not known what causes the aura to initiate in~     patients or what the relationship is between aura and migraine headache, e.g. if treatment~     targeted at aura mechanisms will prevent subsequent headache. Due to the short-lasting and~     unpredictable nature of aura, the only possible approach for systematic investigations is to~     experimentally trigger aura, but currently no method for aura-triggering is available.~      The overall goal of the proposed project is to reveal the earliest mechanisms of the~     migraine attack by investigating the initiating factors of aura in the migraine brain.~      Current animal evidence indicates that infusion of endothelin-1 (ET-1), a naturally~     occurring signaling molecule released from blood vessels, is safe and very likely to trigger~     migraine aura in patients.~      In this project the investigators aim to study the effects of ET-1 on the human brain, to~     investigate aura-inducing effects of ET-1 in patients and to develop a safe and reliable~     method for the experimental induction of migraine aura using ET-1.~   "
11543|NCT02906072|"~     The effect of a diet free from animal-sourced nutrients on body composition in weight~     reduction programs is not well established. In this non-randomised free living~     interventional case-control study, the investigators will document the effects of a 10-week,~     low-fat, plant-based diet supplemented with two daily plant-based meal replacements on body~     composition indices measured with bioimpedance analysis. Control subjects will be exposed to~     weekly lectures on the rationale and expected benefits of plant-based nutrition. The~     investigators hypothesise that low-fat plant based diet supplemented with meal replacements~     eaten ad libitum allows a significant reduction of body fat without the loss of lean tissue.~   "
11544|NCT02906059|"~     The purpose of this study is to determine whether combination therapy of irinotecan with~     AZD1775 is safe and effective in treating mutated metastatic colorectal cancer patients.~   "
11545|NCT02906046|"~     Few studies evaluated the efficacy of adding weights on the lower limbs in patients with~     ataxic disorders. There is no current evidence on which would be the most appropriate weight~     for use in this context. To assess progress and benefits of using this load, gait of~     symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective~     of the study is to evaluate the gait with and without different load weights on lower limbs.~     Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait~     assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about~     which weight they prefer for walking.~   "
11546|NCT02906033|"~     The aim of the study is to improve the surgical patients' care process. The objective is to~     explore the effect of a new perioperative practice model on 1) patient outcomes~     (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes~     (organizational engagement), and 3) organization outcomes (timeline of surgical care~     process).~   "
11547|NCT02906020|"~     Primary Objectives:~        -  Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally,~          as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a~          GBA mutation or other pre-specified variants.~        -  Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as~          compared to placebo in patients with early-stage Parkinson's disease carrying a GBA~          mutation or other pre-specified variants.~      Secondary Objectives:~      Part 1:~        -  To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma~          when administered in early-stage Parkinson's disease patients carrying a GBA mutation.~        -  To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered~          in early-stage Parkinson's disease patients carrying a GBA mutation.~      Part 2:~        -  To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in~          early-stage Parkinson's disease patients carrying a GBA mutation as compared to~          placebo.~        -  To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma~          and CSF as measured by glucosylceramide (GL-1) when administered in early-stage~          Parkinson's disease patients carrying a GBA mutation.~   "
11548|NCT02906007|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of an antituberculosis drug, bedaquiline (BDQ), when used to treat multidrug-resistant~     tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected infants, children, and adolescents.~   "
11549|NCT02905994|"~     The study intervention involved in this study is the addition of a dose of volasertib as a~     part of the initial chemotherapy regimen for AML.~      The trial will involve a combination of the following drugs:~        -  Volasertib (the study drug)~        -  Idarubicin~        -  Cytarabine~   "
11550|NCT02905981|"~     The main purpose is to determine whether Triferic, administered orally with Shohl's~     solution, is safe and effective for the treatment of iron-refractory iron-deficiency anemia~     (IRIDA).~   "
11551|NCT02905968|"~     The purpose of this study is to evaluate the effectiveness of transanual tube placement in~     low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.~   "
11552|NCT02905955|"~     All patients with deep venous obstruction below the sapheno-femoral junction elective for~     hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients~     with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral~     junction) who present with occluded stents which need an additional AVF after thrombolysis~     will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be~     performed afterwards.~   "
11553|NCT02905942|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the~     recovery of hematopoietic function after autologous stem cell transplantation in patients~     with lymphoma.~   "
11554|NCT02905929|"~     Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA)~     Women's Health Program will assess 3-month changes in sitting time, standing time, physical~     activity and blood pressure in a randomized control trial. This 2-arm randomized controlled~     trial (RCT) will occur in the community with post menopausal Latina women (N=250) who spend~     at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high~     BMI and borderline hypertension. Women will be identified through the San Ysidro Health~     Clinic and assessed at the South Bay Latino Research Center.~   "
11556|NCT02905903|"~     Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after~     cutaneous inflammation or injury that frequently affects darker skinned populations.~     Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has~     value in product testing for the treatment of PIH. In this second phase of the study, we~     would like to determine if a lower concentration of TCA-induced PIH is comparable to~     acne-induced PIH.~   "
11557|NCT02905890|"~     The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of~     NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at~     high risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar~     beneficial effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of~     mucosal inflammation.~   "
11558|NCT02905877|"~     Functional disorders, also called psychogenic or psychosomatic are very common, disabling~     and their costs to society are immense.~      Functional movement disorders are abnormal, involuntary movements, that are illogical in~     terms of classic neurology. Intriguingly, they typically manifest when patients pay~     attention to them and disappear with distraction.~      The investigators aim to further the understanding of the pathophysiological mechanisms~     underlying functional neurological disorders in order to improve treatment. In particular~     they aim to understand the effect of attention on movement in general, on functional~     neurological mechanisms and on the sense of agency (of subjective control) over a movement.~      Patients with a functional neurological disorder, patients with an organic neurological~     disorder and healthy participants will perform simple tasks, such as reaching to a target,~     while additional tasks will manipulate their attention. The effects of these attentional~     manipulations will be analysed on several levels: movement performance, analysed by the~     kinematics and electromyography (EMG), psychophysical measures, such as the sense of agency,~     and the neural correlates with functional magnetic resonance imaging (fMRI).~      If the hypothesis turns out to be true, then changing the attentional focus could be used as~     a treatment in functional neurological disorders.~   "
11559|NCT02905864|"~     A randomised, double blind, placebo-controlled, parallel group, and single-centre trial~     investigating the effect of liraglutide on body weight and pain in overweight or obese~     patients with knee osteoarthritis.~      Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a~     low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~   "
11560|NCT02905851|"~     To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline~     or minocycline for acne vulgaris~   "
11561|NCT02905838|"~     To assess and compare the esthetic outcome and clinical performance of anterior maxillary~     all ceramic implant single crowns based either on prefabricated zirconia abutment veneered~     with pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided~     manufacturing) CARES® abutment veneered with hand build-up technique.~      Participants will be recruited from the patient population who has previously received~     dental implant treatment, received a provisional restoration and met the inclusion and~     exclusion criteria according to the study protocol. After final impression, patients will be~     randomised into Group A (prefabricated anatomic abutments ): one-piece screw retained single~     crown using a press technique (fluorapatite glass-ceramic, e.max ZirPress) with cut-back~     technique or Group B (CAD/CAM CARES® abutments): one- piece screw retained single crown with~     a hand build-up technique (fluorapatite veneering ceramic, e.max Ceram). One week after~     final restoration (base line visit) the primary and secondary outcome parameters will be~     assessed. The patients will be followed up to 5 years after final restoration.~   "
11562|NCT02905812|"~     Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard~     care group to assess the feasibility and treatment effect of a multimodal integrative~     intervention for delirium prevention and associated detrimental effects.~      Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess~     feasibility and measures of effect of a multimodal intervention consisting of relaxation~     with guided imagery (RGI), and moderate pressure massage on physiological and psychological~     outcomes of critically ill patients.~      Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment,~     randomization, adherence, timing of intervention, workload), b) calculate estimates and~     variance of treatment effect across outcome measures, c) calculate confidence intervals (CI)~     of incidence proportions, means and standard deviation (SD) of outcome measures in study~     groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60~     participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria:~     Critical illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria:~     Patients: a) with expected ICU LOS< 72 hours, b) with acute neurological illness/ trauma,~     persistent sedation or coma, c) with current history of severe mental health problems and~     dementia, as per history and psychiatrist assessment, c) with hearing impairment or~     conditions not permitting use of headphones, e) on neuro-muscular blockers, f) with~     substance/ alcohol withdrawal, g) enrolled in trials of sedatives, antipsychotics.~      Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a)~     relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure~     massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured~     guided imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II~     Andante). Duration of administration: Up to 5 days while participants still in the ICU.~      Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology:~     Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on~     generalized estimating equations (GEE) with AR(1) correlation structure. Confidence~     intervals will be presented with estimated effects. Primary analysis will be based on all~     available data utilizing data from all assessments.~   "
11563|NCT02905799|"~     The purpose of this study is to determine whether resveratrol is effective in the treatment~     of painful knee osteoarthritis.~   "
11564|NCT02905786|"~     Heart failure (HF) imposes a burden for patients and health economics. Although guidelines~     exist, they are not implemented as such in the Belgian health care system. General~     practitioners (GPs) are confronted with the broadest range of HF management. Therefore, a~     multifaceted intervention will be implemented in Belgian general practice to support GPs in~     the implementation of evidence-based HF guidelines. This multifaceted intervention will~     consist of audit and feedback as a method to detect unrecognized HF patients and increase~     awareness for proactive HF management. Additionally, a NT-proBNP point-of-care test will be~     offered to every practice to improve detection and adequate diagnosis of HF patients.~     Furthermore, a specialist HF nurse will assist GPs in education of patients, optimization of~     treatment and transition of care. The investigators' aim is evaluating the feasibility of~     the implementation of this multifaceted intervention in general practice and the evolution~     in predefined quality indicators.~   "
12932|NCT02887976|"~     An Open-label extension (OLE), expanded access study, to assess long-term safety of~     SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in~     patients who completed study number CHL-AA-201.~   "
11565|NCT02905773|"~     The aim of this study was to evaluate the intensity and duration of postoperative pain after~     the removal of root canal filling material in retreatment procedures of upper incisor teeth~     with chronic apical periodontitis, using different techniques.~      The patients were assigned to three groups of 45 patients, according to the method used to~     remove old canal filling material. The presence of postoperative pain was assessed after 6,~     12, 24, 48, and 72 hours, 7 days, and finally after 10 days.~      The hypothesis of this study: there would be no difference in postoperative pain intensity~     among the groups.~   "
11566|NCT02905760|"~     Right ventricular necrosis increases patient in hospital mortality and can be observed in~     20-50% of patients admitted for during acute myocardial infarction. Current guidelines~     recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV~     load using fluid expansion and if insufficient adding inotropic support. However, several~     experimental studies reported a potential deleterious effect of right ventricular dilation~     related to fluid expansion because right and left ventricular interaction decreases stroke~     volume and cardiac output. Consistently with these finding, a study on a small patient~     sample conducted at Henri Mondor Hospital demonstrates the safety and efficiency of~     furosemide in patients with right ventricular necrosis.~      The present study is a phase 3, interventional, prospective, randomized, multicenter,~     double-blind analysis by intention to treat.~      The main objective is to demonstrate improved hemodynamic parameters in the short term in~     patients admitted for acute myocardial infarction with extension RV treated with furosemide.~      The primary endpoint is compare the change in cardiac output in patients admitted and~     treated by either fluid expansion or furosemide.~      The study population will consist in 88 patients and the duration of subjects' participation~     will be one month.~   "
11567|NCT02905747|"~     The aim of the project is to investigate effects of medical exercise therapy (MET) on~     patients with knee osteoarthritis. MET is a common physical therapy intervention, and the~     project aim to strengthen the evidence of this intervention. An experimental cohort design~     is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical~     tests, questionnaires and accelerometer measurements before, during, and after a 3 month~     period of exercise (3 days per week) with a physical therapist. The project will answer if a~     3 month physical therapy intervention using MET causes changes in pain level, function and~     activity level for patients with knee osteoarthritis. In addition, it will investigate~     whether a single global endurance workout for 30 minutes will have an effect on pain level~     for these patients~   "
11568|NCT02905734|"~     Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on~     nicotine. However, they have no access to tobacco during detention in police cells. Nicotine~     withdrawal symptoms, that include irritability, anxiety and lack of concentration, may~     worsen the arrestee's health status during detention. Nicotine withdrawal is a treatable~     condition. Validated treatments in other situations than police custody include nicotine~     replacement therapy.~      This study is based on the following hypotheses: Manifestations related to nicotine~     withdrawal could increase the discomfort due to detention in police cells, A nicotine~     replacement therapy initiated during detention could improve the course of detention in~     police cells and could be useful in a perspective of long-lasting smoking cessation.~      The primary objective is to evaluate the efficacy of nicotine replacement therapy among~     nicotine-dependent arrestees on the course of detention as perceived by the arrestees. Our~     secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire~     to smoke during detention in police cells and to improve long-term smoking cessation among~     dependent smokers.~      Interventions consist in the single administration of an active treatment (nicotine patch)~     or of a control treatment (placebo patch). Evaluations will include the results of a medical~     examination during detention, a self evaluation by the arrestees of their desire to smoke,~     and medical consultations and evaluations of tobacco use 7-10 days, one month and six months~     later.~   "
11569|NCT02905721|"~     Spectral cardiac CT scan performed in an emergency setting in patients with suspected acute~     myocarditis and presenting one selves with an acute chest pain, allows the non-invasive~     assessment of both the coronary arteries and the myocardium. Delayed iodine~     contrast-enhanced CT imaging should show the inflamed area with an increased uptake of~     iodine contrast agent in the interstitial space, such as the well-known hypersignal seen on~     the myocardial delayed enhancement sequence with MRI (corresponding of an uptake of~     gadolinium contrast agent in the abnormal myocardium).~      This technique has the potential to replace MRI, thus allowing the diagnosis of acute~     myocarditis with a rapid and easily accessible technique. Moreover, it has the additional~     benefit of avoiding invasive coronary angiography in the specific population of patients~     without any significant risk factors of atheromatous disease.~   "
11570|NCT02905708|"~     Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative,~     Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack~     Construction, With a View to Maintaining Normothermia During the Peri-operative Period~   "
11571|NCT02905695|"~     The aim of this placebo-controlled clinical trial is to assess the effectiveness of the~     local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or~     first-degree tear. The pain intensity is measured in immediate postpartum period by using a~     numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during~     rest, defecation and during activities. The safety of Chirocaïne® and the patient~     satisfaction are also evaluated at each time.~   "
11572|NCT02905682|"~     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for~     the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of~     treatment.~   "
11573|NCT02905669|"~     Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a~     promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus~     function. It allows the measurement of esophageal and pylorus distensibility as well as~     contractile activity in response to distension. Examination is useful performed under~     sedation. General anesthesia might affect distensibility values. The aim of this study is to~     normal values for esophageal, esophago-gastric junction and pylorus distensibility in~     controls during an upper gastro-intestinal endoscopy performed under general anesthesia.~   "
13264|NCT02883634|"~     We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy~     applied in a vertebral region-specific or region nonspecific level immediately after~     treatment and 3 and 6 months after randomization.~   "
11574|NCT02905656|"~     To our knowledge, no study has evaluated the independent effects of motivational~     interviewing and rate reduction, individually versus in combination, for motivating smokers~     who are not ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence.~     Given the disseminability and the fact that findings can be readily translated into the~     network of tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ,~     following methods that we have previously implemented and evaluated (HL-123978, CA-127964);~     (2) To randomize 828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources~     (control group); (b) motivational interviewing format recommended by the Clinical Practice~     Guidelines; (c) behavioral and pharmacologic rate reduction, and (d) both motivational~     interviewing and behavioral and pharmacologic rate reduction. This design allows us to~     evaluate the independent and additive effects of motivational interviewing and rate~     reduction on quit attempts and smoking cessation.~      We plan to evaluate the efficacy of the intervention utilizing point prevalence at the~     12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper~     concluded that point prevalence (7 days without a cigarette, not even a puff) is an~     appropriate measure in measuring long term outcome in cessation induction trials. Prolonged~     abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the~     12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction,~     tobacco dependence, intentions, motivation, and confidence to quit, and intervention~     adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested~     as important treatment mediators.~   "
11575|NCT02905643|"~     One-third of all primary brain tumors are astrocytomas, the most common type of glioma.~     Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of~     all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality~     rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is~     assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance~     images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes~     which, like actual tumor progression itself, demonstrate contrast enhancement on the first~     post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of~     treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard~     noninvasive tool for distinguishing between pseudoprogression and progressive disease.~     Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits~     measurement of hemodynamic imaging variables. Previous literature reports attempted to use~     some or all of these metrics to assess their utility in distinguishing PsP from true cancer~     progression. These studies showed mixed results, likely due to a number of factors,~     including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and~     types, and varied analysis methodologies. The investigators aim to address these issues in~     this study.~   "
11576|NCT02905630|"~     This pilot study evaluates the effect of exercise training on CFR, functional capacity,~     heart rate variability, endothelial function and quality of life in patients with no~     obstructive coronary artery disease and angina.~   "
11577|NCT02905617|"~     A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast~     Implants~   "
11578|NCT02905604|"~     The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS)~     with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective~     treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression.~     Other objectives are to increase the understanding of the underlying neurobiology of~     negative symptoms and the mechanisms for the treatment effect of rTMS.~   "
11579|NCT02905591|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy~     for non-small cell lung cancer. The standard therapy is radiation therapy combined with~     carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose~     ascorbate in addition to the standard therapy.~   "
11580|NCT02905578|"~     This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for~     metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). All subjects receive~     high-dose ascorbate in addition to the standard treatment.~   "
11581|NCT02905565|"~     This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on study of~     NBP softgel capsules for the treatment of mild to moderate cortical AIS in adult~     subjects.The co-primary objectives of this study include the following:~        -  To assess the safety and tolerability of 3 dose levels of daily NBP in the treatment of~          subjects with mild to moderate cortical AIS.~        -  To determine the efficacy of 3 dose levels of daily NBP in the treatment of subjects~          with mild to moderate cortical AIS.~   "
11582|NCT02905552|"~     Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone~     marrow failure and by a disorder of the medullary production which is a pre-leukemic state~     which can evolve into acute myeloid leukemia.~      The risk of leukemic transformation is estimated by the score IPSS (International Prognostic~     Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of~     leukemic transformation (IPSS=1,5).~      Besides the risk of leukemic transformation, MDS much be complicated of infections which~     could be life-threatening.~      The risk of developing first infection after the diagnosis of MDS of high risk is probably~     influenced by anamnestic (disease duration, comorbidities), clinical (veinous central~     catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin)~     and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions,~     anti-infectious preventive treatment) factors. Their identification will allow for improved~     targeting of the population which is is likely to benefit from anti-infective prophylaxis~     Primary objective is to identify risk factors associated with first acute episode of~     infection in patients with MDS, by comparing index cases and matched control cases who did~     not develop infection episode since diagnosis.~      Secondary objectives are to explore nature and severity of infectious episodes, number of~     recurrences during 1 year of follow up and survival at 6 and 12 months~   "
11583|NCT02905539|"~     The purpose of this study is to determine to what extend a treatment with the iron compounds~     Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study~     the potential clinical impact of hypophosphatemia.~   "
11671|NCT02904395|"~     Given the 100 fold increase of the incidence of Pompe's disease in Western French Guiana,~     the objective of the present study is to implement systematic screening in newborns in~     French Guiana in order to start treatment before the muscular and cardiac symptoms appear.~   "
11584|NCT02905526|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone app instant messaging on use of effective contraception in~     Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion,~     Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3~     instant messages a day for 4 months (intervention). Participants will complete a~     questionnaire at baseline and 4 month follow-up.~   "
11585|NCT02905513|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone app instant messaging on the acceptability of effective~     contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to~     the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app~     plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a~     questionnaire at baseline and 4 months.~   "
11586|NCT02905500|"~     AVIRON study aims at estimating the burden of various causes of death and morbidity in the~     Reunion Island population.~   "
11587|NCT02905487|"~     ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and~     C-reactive protein in obese women and their newborn at delivery whether exposed or not to~     Gestational Diabetes Mellitus (GDM)~   "
11588|NCT02905474|"~     Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often~     take multiple medications and frequently have serious medication problems, arising from poor~     communication between doctors and patients. Prescription errors or misunderstandings can~     cause harm and lead to emergency room visits or even hospitalizations. To address these~     issues, medication reconciliation is now used by hospitals as a way to confirm the~     medication list of patients on admission to and discharge from hospital. However, a similar~     process does not exist outside the hospital setting. In recent years patients have become~     more proactive in undertaking activities with a direct bearing on their health. Such~     activities may include maintaining an accurate list of their medications. The rapid growth~     of the digital health arena has led to the development of a large number of commercially~     available mobile medication management apps for patients. These digital tools are~     'stand-alone' products that are not integrated with the patients' pharmacy or health record~     system. They rely on patients to enter the list of their medications and update it as~     necessary. Moreover, few have a function to communicate medication changes or problems with~     their healthcare providers. Recently, an integrated smartphone, eKidneyCare, app system was~     developed with a medication management feature to help patients maintain an accurate mobile~     medication list. Patients' current medication information in the pharmacy database is~     uploaded onto their by a pharmacist and changes are tracked regularly through a~     bi-directional communication system. Updates to the medication list occur seamlessly by the~     pharmacist, and patients and their physicians are notified about any medication errors or~     serious adverse events. This study will determine whether our eKidneyCare app with its~     medication management feature will decrease medication errors and improve patient safety~     compared to the more traditional way of managing medications.~   "
11589|NCT02905461|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone text message on the acceptability of effective contraception in~     Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4~     months (intervention) or a monthly text message not about contraception (control).~     Participants will complete a questionnaire at baseline and 4 month follow-up.~   "
11590|NCT02905448|"~     The effect of a diet free from animal-sourced nutrients on a variety of risk factors for~     chronic non-communicable diseases in weight reduction programs is not well established. In~     this non-randomised interventional study, the investigators will document the effects of a~     low-fat, plant-based diet supplemented with two daily plant-based meal replacements on serum~     LDL cholesterol as a primary end-point and total cholesterol, triglycerides, serum fasting~     glucose, serum urate, serum insulin-like growth factor 1 (IGF-1) and body fat mass as~     secondary end-points. These end-points will be measured at baseline, after 10 weeks and~     after 30 weeks of intervention. Participants will be enrolled in the interventional arm with~     prescribed low fat plant-based diet from the group of all applicants to a free living~     population-based diet optimising program. The choice to participate in the study will be~     made by participants themselves.~      The investigators hypothesise that low-fat plant based diet supplemented with plant-based~     meal replacements eaten ad libitum allows a significant reduction of serum LDL cholesterol~     concentration.~   "
11591|NCT02905435|"~     This is a multi-center, single arm, traditional feasibility study to allow a preliminary~     assessment of the safety and effectiveness of a new method of treating skin burns using~     Biodegradable Temporizing Matrix (BTM).~   "
11592|NCT02905422|"~     The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy~     Eating Activity Lifestyle Training Headquarters) previously tested that has been developed~     specifically for use by Army Soldiers and a remote clinical intervention model that includes~     mobile tracking technology/devices for physical activity, weight and nutrition. This program~     is called the H.E.A.L.T.H. Intensive.~   "
11593|NCT02905409|"~     The purpose of this study is to determine the effects of two different internal limiting~     membrane peeling with distinct diameters on anatomical closure grades after macular surgery~     measured by OCT (optical coherence tomography.).~   "
11594|NCT02905396|"~     Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and~     unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as~     burning pain in the extremities in combination with autonomic symptoms. So far, the results~     of symptomatic SFN treatment have been rather disappointing, despite the fact that new~     agents have been developed.~      This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined~     with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in~     patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction~     on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time,~     and/or at least much improved or very much improved, on the Patient Global Impression of~     Change (PGIC) for pain and sleep.~   "
11595|NCT02905383|"~     The aim of this study is to investigate the effect of a multi-component exercise program on~     physical function, physical activity and health-related quality of life (HRQOL) in older~     people recently discharged from hospital. The intervention consists of 32 group-based~     exercise sessions, performed twice a week. In addition the participants in the intervention~     group will be encouraged to perform an exercise program on their own, at least once weekly.~     The participants in the control group will be encouraged to exercise on their own, according~     to the World Health Organization (WHO) recommendations on physical activity for adults aged~     65 and above.~   "
11596|NCT02905370|"~     This research study explores the effects of a progressive, multi-component intervention~     following a stay in the hospital or rehabilitation facility. The purpose of this research~     study is to compare a multi-component intervention (higher intensity exercise, nutritional~     supplementation, and greater emphasis on functionally enhanced care transitions) with usual~     care physical therapy.~   "
11598|NCT02905344|"~     Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients~     follow through with elective surgeries to fix ailments like a deviated septum or occluded~     sinus passage. Patient understanding of their diagnosis and treatment plan is integral to~     compliance, which ultimately yields improved medical outcomes and better quality of life.~     Here the investigators report the usage of advanced inkjet 3D printing methods to develop a~     multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray~     Computed Tomography (CT) data. The final patient education model was developed over several~     iterations to optimize material properties, anatomical accuracy and overall display. A two~     arm, single center, randomized, prospective study was then performed in which 50 ENT~     surgical candidates (and an associated control group, n = 50) were given an explanation of~     their anatomy, disease state, and treatment options using the education model as an aid.~     Each patient was then surveyed for their self-rated understanding of their anatomy, disease,~     and treatment options.~   "
11599|NCT02905331|"~     The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics,~     immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device~     in participants with moderate to severe plaque-type psoriasis.~   "
11600|NCT02905318|"~     The purpose of this study is to find out what effects a new drug, palbociclib, has on~     prostate cancer and will look at the side effects of treatment with palbociclib. The~     researchers doing this study are also interested in looking for markers that may help~     predict which patients are most likely to be helped by palbociclib and to see how the cancer~     cells respond to palbociclib.~   "
11601|NCT02905305|"~     In an effort to further preserve residual acoustic hearing after cochlear implantation, it~     may be beneficial to incorporate anti-inflammatory agents into the electrode array for~     passive elution over a time course after implantation. This study aims to assess the ease~     and effectiveness of such an electrode design, and to assess the preliminary safety of use~     of such a device in the post-operative period. This study is a first-time-in-human study of~     the investigational device.~      In the first instance, the aim of the current investigation is to obtain first experience in~     use of a Combined Device in the adult clinical population, and to assess tools and~     techniques that may be considered in future clinical studies of similar devices.~   "
11602|NCT02905292|"~     The overall objective of the research is to identify the prevalence and incidence of BPPV~     and the impact on balance problems, fall risk and inactivity in frail elderly. The~     investigators will demonstrate the importance of early diagnosis and treatment in this~     patient group.~   "
11603|NCT02905279|"~     This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by~     the use of antagonistic or opposite actions during treatment. The goal of the study is to~     compare the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions~     in extinguishing fear.~   "
11604|NCT02905266|"~     This is a safety and efficacy study of different administration regimens of nivolumab plus~     Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.~   "
11605|NCT02905253|"~     The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and~     well-tolerated when orally administered at single- and multiple-ascending dose to healthy~     adults~   "
11606|NCT02905240|"~     A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the~     efficacy of a single dose of Autologous Protein Solution (APS) in patients with~     Osteoarthritis (OA) of the knee.~   "
11607|NCT02905227|"~     This study is an open-label, parallel group study to evaluate acute pulmonary safety and~     Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation~     powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.~   "
11608|NCT02905214|"~     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex~     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions~     after stand-alone angioplasty in coronary arteries.~   "
11609|NCT02905201|"~     The primary purpose of this study is to determine the rate of compliance to abiraterone~     acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic~     prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a~     real-world clinical setting.~   "
11610|NCT02905188|"~     This study enrolls patients who have a type of cancer that arises from the liver called~     hepatocellular carcinoma. The cancer has come back, has not gone away after standard~     treatment or the patient cannot receive standard treatment. This research study uses special~     immune system cells called GLYCAR T cells, a new experimental treatment.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. In preclinical studies, the~     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody~     called GC33 that recognizes glypican-3, a protein found on almost all hepatocellular~     carcinoma cells (GPC3-CAR). This study will test T cells genetically engineered with a~     GPC3-CAR (GLYCAR T cells) in patients with hepatocellular carcinoma.~      The GLYCAR T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the biggest dose of GLYCAR T cells that is safe, to see~     how long they last in the body, to learn what the side effects are and to see if the GLYCAR~     T cells will help people with GPC3-positive hepatocellular carcinoma.~   "
11672|NCT02904369|"~     This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral~     tablets to assess systemic and genital tract bioavailability in healthy women. The oral~     tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300~     mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.~   "
11673|NCT02904356|"~     The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS)~     on brain imaging and neurophysiological measures of cognitive control in patients with~     Obsessive-Compulsive Disorder (OCD).~   "
11611|NCT02905175|"~     Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint~     destruction strongly correlated with anti-citrullinated protein antibodies citrullinated~     anti-peptide (ACPA). Precise RA etiology remained unclear with a described association~     between RA and periodontal disease. The missing link could be a gram-negative anaerobic~     bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in~     periodontal disease and able to induce gingival citrullinated protein via an enzyme called~     peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and~     in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in~     RA, the investigators will compare its effect on various cell type with comparison with~     another oral bacteria Provatella intermedia.~   "
11612|NCT02905162|"~     To inform the design of a future transitional HIV care intervention for releasees, the study~     proposes to prospectively assess clinical outcomes for HIV-infected prisoners after release;~     explore factors from health behavior theory that are associated with post-release retention~     in care, with a special focus on Alcohol Use Disorders (AUDs); and conduct formative~     research to determine releasee and stakeholder knowledge, attitudes, and preferences~     surrounding transitional care interventions.~   "
11613|NCT02905149|"~     The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia~     technique ( interfascial block at the serratus muscle) performed in patient undergoing~     breast surgery and the effect of this technique on postoperative analgesia.~   "
11614|NCT02905136|"~     Neurological and psychiatric diseases are one of the major health problems worldwide.~     Decades of fundamental and clinical research have led to the model that these disorders~     results from synaptic imbalance between excitatory, inhibitory and modulatory systems in key~     brain structures. Although the network and neurotransmitter systems involved have been~     delineated, the mechanisms leading to improper neurotransmissions remain poorly understood.~     One major limitation lays in the difficulty to transpose the identified dysregulation in~     humans to relevant animal models in which molecular and cellular targets can be manipulated.~      The amino-acid glutamate mediates the vast majority of excitatory neurotransmission in the~     mammalian brain. We know that the glutamatergic synapses can change their strength by~     regulating surface expression and dynamics of their postsynaptic receptors, through changes~     in receptor recycling and/or lateral diffusion. This synaptic plasticity underlies higher~     cognitive functions such as learning and memory and is likely compromised in several disease~     states. Regulating glutamate receptor number and function is thus of primary importance. New~     subcellular imaging technique rendered possible the study of receptor trafficking and~     receptor regulation in various conditions including pathological models opening new~     fundamental questions. Moreover, recent breakthroughs on glutamate receptor structure offer~     unprecedented clues on the molecular and structural mechanisms underpinning receptor~     dysfunction at the atomic level.~      Recently, description of encephalitis associated with specific autoantibodies (Abs) directed~     against neuronal synaptic receptors or proteins (NSA-Abs) opens new lights in the~     pathophysiological mechanisms of some human brain disorders. The best example and the most~     frequent syndrome is the synaptic autoimmune encephalitis associated with autoantibodies~     against extracellular domains of the glutamatergic NMDA receptor (NMDAR-Abs). Classically,~     patients first present psychiatric symptoms with hallucinations and bizarre behavior before~     development of neurological symptoms such as seizures, dyskinesia, and autonomic~     instability. Despite the severity of neuropsychiatric symptoms, more than 80% of patients~     fully recover after immunomodulatory treatments and many arguments suggest a direct role of~     NMDAR-Abs in the symptoms. The investigators recently demonstrated that NMDAR-Abs directly~     modify, at the synaptic level, NMDAR lateral diffusion by disruption of the interaction~     between NMDAR and EphrinB2 receptor, a synaptic protein anchoring NMDAR at the synapse~     (Mikasova et al, Brain 2012; Dupuis et al, EMBOJ 2014). These data suggest that NMDAR-Abs~     could directly participate in the neuropsychiatric disorders observed in patients and that~     NMDAR dysfunctions could be directly responsible for the observed symptoms. Furthermore,~     these data suggest that other NSA-Abs directed against other synaptic proteins could explain~     specific neurological symptoms in patients with encephalitis that are not associated with~     NMDAR-Abs.~      The aim of MECANO is to combine multidisciplinary approaches (clinical, immunological, and~     neurobiological ones) to identify new NSA-Abs, to characterize their specific pathological~     roles and to decipher acute and chronic NMDAR-Abs effects on biophysical and structural~     properties of the NMDA receptor, synaptic plasticity, neuronal morphology, and cognitive~     performance. This project should provide key insights onto the effects of patients' NSA-Abs~     on the cellular dynamic and regulation of synaptic proteins or receptors and on the~     molecular cascades activated during synapse dysfunction. The investigators will investigate~     how NSA-Abs binding alter receptor activity, modify surface receptor mobility and~     dynamically regulate the maturation of synapses and circuitries. For that purpose, The~     investigators will use a unique combination of high-resolution imaging (single nanoparticle~     tracking), receptor engineering, cellular electrophysiology, computational (structural~     modeling) and cellular and molecular biology approaches and finally behaviour assays. Based~     on both cutting-edge neurobiology and clinical expertise of autoimmune disorders, and~     strengthened by promising preliminary experiments, the MECANO project will likely open new~     avenues of fundamental research in the understanding of synaptic dysfunction and clinical~     research for the treatment of neuropsychiatric disorders.~   "
11615|NCT02905123|"~     Amazon's Mechanical Turk (MTurk) is an online platform that has become a popular means of~     recruiting participants with problem drinking, gambling, or even illicit drug use for the~     purposes of survey-based research. There is also the possibility that potential participants~     could be identified through MTurk for online longitudinal studies, including for brief~     intervention research. The potential to quickly and easily identify large numbers of~     participants through MTurk is important for research evaluating online interventions during~     the period that these interventions are being developed and refined. However, before~     proposing MTurk workers as a viable source for participants in online intervention trials,~     it is important to evaluate the feasibility of using MTurk for such a purpose. This pilot~     study proposes to test this feasibility by systematically replicating a trial of an~     extensively evaluated brief online intervention for hazardous alcohol use~     (CheckYourDrinking; CYD) and will attempt to recruit and follow-up participants for this~     replication using people recruited through MTurk.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants~     identified as problem drinkers based on an initial survey will be invited to complete~     another survey in 3 months time. Those who are interested will be randomized to receive~     access to the Check Your Drinking screener (CYD condition) or to a no additional information~     condition (control condition). At three-months post-baseline, the MTurk portal will be used~     to send invitation emails that contain a link to the follow-up survey. The primary~     hypothesis to be tested is that participants receiving access to the CYD intervention will~     report a greater level of reduction in number of drinks in a typical week between the~     baseline survey and three-month follow-up as compared to participants in the no information~     control condition.~   "
11616|NCT02905110|"~     The goal of this clinical research study is to establish the safety of simultaneous~     infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection~     cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors~     include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant~     brain tumor with recurrence or progression involving anywhere in the brain and/or spine.~     Patients' disease must have originated in the posterior fossa of the brain.~   "
11617|NCT02905097|"~     The aim of the study is to assess the performance of the cementless Triathlon Tritanium~     tibial baseplate for total knee replacement, with a minimum follow up of 5 years.~   "
11618|NCT02905084|"~     The environment of the ICU and operating room allows the multi continuous monitoring of~     patients in critical situations. The physician anesthesiologist is working more and more in~     an environment where he receives a multitude of information from both the patient's medical~     history but also measured data in real time to its physiological situation. It is sometimes~     difficult for practitioners to consider all of the information by identifying a course of~     action. A decision support and a degree of automation can increase security along the lines~     of what has been observed in many processes and industries like aviation.~      The goal of this project is to establish initially a database of physiological parameters.~     We want to use patient data to model physiological processes in order to advance towards the~     creation of physios program,~   "
11619|NCT02905071|"~     The main objective of this work is to explore the psychometric properties of scale of~     well-being at work called Serenat in order to validate it. Secondary objectives are to~     study the influence of socio-demographic characteristics of the subjects on the results of~     Serenat and to describe the results on subjects monitored among an adult psychiatric~     population.~   "
11620|NCT02905058|"~     IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix~     and straighten the uterus for proper insertion; trans-cervical actions including measuring~     uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the~     device in the uterus.~   "
11621|NCT02905045|"~     hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to~     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions~     including measuring uterine depth, inserting the cannula; and injection of the dye~   "
11622|NCT02905032|"~     The objective of this project is to evaluate a treatment decision aid for patients with~     atrial fibrillation.~   "
11623|NCT02905019|"~     The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and~     in combination with viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and~     MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive~     volunteers.~      Healthy adult volunteers will be recruited in London, Oxford and Southampton, England.~      All vaccinations will be administered intramuscularly. Each volunteer will receive either~     three or five vaccinations in total, depending on the group.~   "
11624|NCT02905006|"~     This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics~     (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with~     moderate to severe chronic plaque psoriasis in order to guide the selection of doses and~     clinical indices in the Phase 3 development program.~   "
11625|NCT02904993|"~     To compare two methods of post-operative pain management in patients undergoing total hip~     arthroplasty. There is a perception that the periarticular injections may not be as~     effective in controlling post-operative pain.~      Both methods are current standard of care. The investigators want to compare the outcomes of~     each when patients are randomized to one of the methods compared to the other method of~     post-operative pain control.~   "
11627|NCT02904967|"~     Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a~     chronic disease with a recurrence rate of 30% at 10 years.~      Reduce the risk of recurrence is a serious public health issue. For this it is necessary to~     identify patients at high risk of recurrence. However, until now, only 50% of recurrences~     are in the presence of known risk factors, suggesting that there are still yet unidentified~     risk factors.~      The assumption behind this project is that there are specifically associated genetic~     polymorphisms to the risk of VTE recurrence.~      The aim of our project is to identify these polymorphisms from genome-wide data MARTHA~     cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one~     episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for~     approximately 500,000 polymorphisms.~      The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects~     with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the~     controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be~     compared between cases and controls. The identification of these new genetic variants~     associated with VTE recurrence should allow us to improve the pathophysiological knowledge~     of the disease, reduce the frequency of episodes and focus research on new therapeutic~     approaches.~   "
11628|NCT02904954|"~     The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736)~     with or without stereotactic body radiation therapy (SBRT) as treatment for stage IB and II~     non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.~   "
11629|NCT02904941|"~     This is a randomised trial that aims to evaluate whether a transient skin cover made out of~     human amniotic membranes is effective in managing burns among pediatric patients. The~     primary outcome of this trial is the proportion of skin grafted amongst participants.~     Secondary outcomes include hospital stay and the number of surgical debridements required by~     included patients.~   "
11630|NCT02904928|"~     With the increasing number of advanced surgical operations being done annually, including~     the elderly, the risk of developing postoperative delirium is potentially high.~     Postoperative delirium is associated with longer hospital stay, poorer functional outcome,~     cognitive decline and an elevated morbidity and mortality, in addition to an increased cost~     of health care. However, most of the studies on postoperative delirium have been done in~     high income countries, leaving a paucity of literature on the incidence and associated~     factors of postoperative delirium in Africa and hence a need to do this study.~   "
11631|NCT02904915|"~     The purpose of this study is to compare the pain level and level of discomfort with~     paracervical block versus no analgesia in women who present to the University of Texas (UT)~     Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center,~     and the UT Physicians Women's Center- Bellaire for IUD insertion.~   "
11632|NCT02904902|"~     This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese~     subjects with moderate to severe Hidradenitis Suppurativa (HS).~   "
11633|NCT02904889|"~     Most older adults want to stay at home for as long as possible. To reach this aim it is~     important to maintain their mobility and self-care abilities. However, many older adults are~     at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare~     professionals learn to motivate their clients to be more active in daily and physical~     activities. Examples of these activities are washing and dressing, household chores or going~     for a walk.~      The primary aim of this exploratory study is to evaluate the implementation of the 'Stay~     Active at Home' program (process evaluation). The secondary aim is to get insight into the~     potential effectiveness of the program with regard to several primary and secondary outcomes~     measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed~     study design.~   "
11634|NCT02904876|"~     Through this phase IV study, multicenter prospective exploratory, uncontrolled, the~     investigators propose to identify MRI predictive factors of treatment response, using~     diffusion MRI sequences, in addition to conventional sequences.~      The primary objective is to study the links between changes on MRI diffusion and response to~     treatment with Tysabri to 2 years.~      The secondary objective is to compare the evolution of diffusion MRI data with the~     volumetric MRI data.~   "
11635|NCT02904863|"~     The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting~     both children and adults. HUS is characterized by the abnormal occurrence of diffuse~     thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting~     especially the kidneys and is associated with hemolytic anemia. One of the major problems~     encountered in the management of HUS is the absence of reliable marker of treatment response~     or relapse; conventional hematological markers being too insensitive to judge therapeutic~     efficacy or identify early relapse. Data from the literature suggest that the endothelial~     cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial~     activation plays a critical role in the initiation and / or relapse of the disease.The main~     objective of this study is to define a vascular competence profile in a population of~     patients with typical or atypical HUS; both in the acute phase and in remission of the~     disease.~   "
11636|NCT02904850|"~     Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a~     pharmacokinetic (PK) has been prepared using data from the literature. This model must be~     validated at concentrations achieved in practice. This is a preliminary study before the~     implementation of a randomized trial confirming the therapeutic monitoring of erlotinib~     through this model.~   "
11637|NCT02904837|"~     Parkinson's disease (PD) is a progressive degenerative nervous system disease that causes,~     among other changes, movement disorders that lead to loss of motor skills, especially in~     gait. The use of mental practice (MP) as a method for the acquisition and improvement of~     motor skills is well evidenced in the literature for healthy individuals and stroke~     patients, but there is still insufficient evidence for the effectiveness of this method in~     PD gait improvement. The purpose of this study is to evaluate the effects of MP combined~     with physical practice(PP) for gait training guided by cognitive strategies in patients with~     PD.~   "
11852|NCT02902016|"~     This study is designed to assess the effect of a new PPARgamma modulator on the expression~     and activity of the lactase enzyme in human intestinal epithelial cells. Based on their~     previous experimental results, the investigators hypothesized that modulating intestinal~     PPARgamma activity is a new pharmacological mechanism allowing the control of lactase~     expression and activity in the gut~   "
11638|NCT02904824|"~     This is the first Development Safety Update Report prepared for Phase I-IIA Clinical Trial-~     FIBHGM-ECNC007-2010 (PHASE I / IIA CLINICAL TRIAL, UNICENTRIC, RANDOMIZED, CONTROLLED, TWO~     PARALLEL-GROUPS, TO EVALUATE THE SAFETY OF A NEW THERAPY WITH STEM CELLS DERIVED FROM~     ADIPOSE TISSUE FOR GLOTTAL GAP(GG) IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD(VC) ) in~     the International Conference on Harmonization (ICH). Patients are randomized to receive one~     of the following therapeutic strategies:~      Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord. Group B:~     Autologous Fat enriched with stem cells from adipose tissue to treat vocal cord paralysis.~      Active control: Autologous fat tissue processed by centrifugation. Route of administration:~     Injection into a paralyzed vocal cord.~      Experimental drug: Stem cells from autologous adipose tissue in which autologous tissue is~     enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the~     overexpression and production of microvessels at local level. Route of administration:~     injection into the thickness of a paralyzed vocal cord.~   "
11639|NCT02904811|"~     The main objective of the study is to determine whether early screening and treating young~     women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the~     cumulative incidence of pelvic inflammatory disease (PID) over 24 months.~      As secondary objectives, the study aims~        -  To determine the baseline prevalence and the incidence of Ct infection;~        -  To improve knowledge on natural history of Ct infection in young women such as the rate~          and timing of progression to PID (at the beginning of the infection, at the end,~          throughout the course of infection), as well as the incidence of reinfections with Ct;~        -  To investigate the relation between host immuno-genetic factors and the clearance,~          persistence and development of late complications (PID) as an explanation for the~          inter-individual heterogeneity in the susceptibility to and course of Ct infection.~   "
11640|NCT02904798|"~     Polypodium Leucotomos Extract (PLE) is a tropical fern that has antioxidative,~     photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties. The~     antioxidative effects of PL include inhibition and scavenging of free radicals, lipid~     peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion,~     hydroxyl radical and singlet oxygen. Visible light (400-700 nm) causes pigmentation in~     melanocompetent individuals and induces DNA damage in the human skin through ROS production.~     The goal of this study is to determine whether the administration of oral PLE has an effect~     on the development of visible light induced pigmentation.~   "
11641|NCT02904785|"~     The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy~     reduces knee pain and enhance function in patients with primary knee osteoarthritis.~   "
11642|NCT02904772|"~     The aim of the study is to provide further confirmatory evidence of clinical benefit in LPLD~     patients treated with alipogene tiparvovec by assessing both the clinical response (as~     defined by a range of parameters), and the metabolic response (postprandial CM metabolism)~     in LPLD patients with and without an immunosuppressant regimen.~   "
11643|NCT02904759|"~     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for~     the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of~     treatment.~   "
11644|NCT02904746|"~     This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute~     intervention aimed at increasing attendance to a follow-up appointment for psychological~     services (i.e., an information class) among clients accessing walk-in services at a mental~     health crisis response centre. As a secondary aim, we will examine the demographic~     correlates, presenting problems, and symptom correlates of clients who do and do not attend~     follow-up services.~   "
11645|NCT02904733|"~     A large (3900 patients) cohort study, undertaken in five European sites to validate in a~     mHealth platform to enable self-management of HIV in patients with stable disease using a~     tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically~     developed for the assessment of mHealth solutions.~      As site recruitment will be sequential and the recruitment period will last 18 months, a~     maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline~     defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.~   "
11646|NCT02904720|"~     The purpose of this study is to determine the prevalence of vitamin D deficiency among the~     population of pregnant women receiving prenatal care and giving birth at the investigators'~     clinic. The further purposes are to identify the population at risk for vitamin D deficiency~     and to analyse whether vitamin D deficiency is associated with pregnancy complications.~   "
11647|NCT02904707|"~     Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks,~     between the knee and foot, and with no tendency to spontaneous healing.~      In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general~     population and 3% in subjects over 65 years.~      The sex ratio is generally 3 females to 1 male. It is in most cases a complication of~     vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and~     microcirculatory.~      In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions~     (sleep disorders, eating, work stoppages) and major economic (individual and collective~     costs of absorptions).~      The treatment of a chronic wound uses validated techniques for several years as the skin~     graft in tablets, associated with the etiological treatment.~      The latest recommendations HAS implemented to date from 2006 and concerns the management of~     leg ulcers predominantly venous.~      Few articles in the literature address the possibility of an analgesic effect of the~     transplant pellets in the treatment of chronic ulcers algic.~      In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg~     ulcer patients and feet and showed that there was a reduction in pain post transplant.~      We propose to evaluate the analgesic effect of the skin graft in pellet on a patient~     population having one or more Algic ulcers.~   "
11674|NCT02904343|"~     An important reason for the costs of hemodialysis treatment in China are expensive is the~     hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is~     the basis equipment of the hemodialysis treatment. After years of research and development,~     China has had the domestic hemodialysis machine. However, due to the lack of control studies~     of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis~     machine promotion has been hindered. The aim of this study is to verify the quality and~     safety of domestic hemodialysis machine.~   "
11648|NCT02904694|"~     A national database is being set-up to collate clinical outcome information before and after~     children undergo Selective Dorsal Rhizotomy (SDR). SDR is a surgical procedure that has been~     used for many years but has not been routinely available within the United Kingdom National~     Health Service (NHS). The SDR procedure is used to improve spasticity in children with~     cerebral palsy and involves dividing some of the nerve fibres running from the muscles back~     to the spinal cord. While it is believed that SDR is effective, there are no definitive~     data. In July 2014 NHS England commissioned five NHS Trusts to undertake SDR surgery in~     eligible children for a two-year period, and to collect detailed information on their~     outcomes. The proposed database will aggregate these data from the five centres and analyse~     them to provide overall evidence on the clinical effectiveness of SDR. This information will~     be used to inform future commissioning decisions. The database has been developed by the~     King's Technology Evaluation Centre (KiTEC) in conjunction with NHS England and the national~     clinical SDR steering committee and its data subcommittee. KiTEC undertakes research~     evaluations for the National Institute for Health and Care Excellence (NICE), and has been~     commissioned by NICE to undertake this work. Clinicians in the SDR data subgroup have~     liaised closely with KiTEC to agree which data to collect so that it the least amount needed~     and will be in a standardised format across all centres. When all two-year outcome data are~     recorded, KiTEC will analyse the data and present a report to NHS England, NICE and the SDR~     steering committee and data sub-group. While there are no firm plans to follow the children~     beyond two years post-surgery, all parties involved are hoping that further funding can be~     obtained to continue following these children up as these data will be unique.~   "
11649|NCT02904681|"~     Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired~     vertebral structure occurring in children and adolescents with involvement of the growth~     cartilage causing impaired growth and kyphosis.~      There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical~     expressions; the most important being kyphosis with spinal stiffness associated with painful~     elements.~      The radiographic definition according Sorenson is uniformisation 5 ° affecting at least~     three adjacent vertebrae.~      Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain~     which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover~     disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally,~     scalability because the curvature may increase the likelihood of degenerative lesions disc~     degeneration or lumbar spinal stenosis for example.~      When the disease is diagnosed early, treatment is most often associated with orthopedic~     physiotherapy. However, for patients with active deformation, despite an orthopedic brace~     treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical~     decision can be taken.~      The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes~     through a spinal fusion must be released from his column stiffness in a bad position,~     changing the equilibrium profile and ensure that it remains in a good position.~      This surgery usually requires a prior operative time (thoracic surgery to remove the~     intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with~     a bone graft and osteosynthesis). Currently different surgical strategies are practiced~     there is no real consensus between the teams.~   "
11650|NCT02904668|"~     Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck~     movements or sustained neck postures. The onset and course of this pain is influenced by~     environmental and personal factors.Many studies report that participants preferred self-care~     measures for the management of neck pain and they sought professional help only when those~     measures fail~   "
11651|NCT02904655|"~     The study is a randomized, crossover meal-replacement pilot intervention to determine~     feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for~     the impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma~     were randomized to crossover trial of a 4-week dietary intervention or usual diet with a~     4-week washout period. During the dietary intervention, all meals and snacks were provided~     by the study.~   "
11652|NCT02904642|"~     The overall objective is to test the impact of short message service (SMS) reminders, with~     or without unconditionally provided mobile-money incentives, can improve measles vaccination~     coverage in rural western Kenyan infants.~   "
11653|NCT02904629|"~     The objective of this research study is to evaluate a culturally tailored sexual and~     reproductive health intervention among American Indian (AI) youth. Specifically, the~     investigators aim to evaluate the impact of Respecting the Circle of Life: Mind, Body and~     Spirit on knowledge, attitude and behavioral outcomes associated with risk for unprotected~     sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized~     controlled trial on the White Mountain Apache (WMA) reservation. The investigators will~     examine whether the RCL intervention effectively reduces risky sexual behavior among AI~     adolescents (11-19 years old), with long term goals of reducing teen pregnancy and~     incidence/prevalence of STIs. The evaluation will focus on well-established intermediate~     outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI~     incidence.~   "
11654|NCT02904616|"~     The Institut has developed a spectrofluorimeter for the registration and monitoring of skin~     autofluorescence.~      This Spectrofluorometer must be initially validated in healthy volunteers. In the long term,~     it will be used clinically to measure residual photosensitivity of patients who received a~     photosensitizer in photodynamic therapy.~   "
11655|NCT02904603|"~     Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis~     C infection. In this study cytokine markers will be measured during therapy up to time point~     SVR 12 an correlated to clinical Parameters and regular laboratory findings.~   "
11656|NCT02904590|"~     The purpose of this study is to determine the incidence and risk factors related to~     Infection in patients with Inflammatory Bowel Disease (IBD)~   "
11657|NCT02904577|"~     Prospective collection of data of possible prognostic relevance in patients with indolent~     non - follicular B-CELL Lymphomas.~   "
11658|NCT02904564|"~     The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine~     Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation~     compared to conventional Microneedling. MMP is a procedure done with tattoo devices using~     medication in place of ink.~   "
11659|NCT02904551|"~     This prospective controlled randomized blind clinical study investigated 44 implants~     displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral~     prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG,~     gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were~     assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline,~     were assessed at 18 months.~   "
11706|NCT02903914|"~     This study is an open-label Phase 1 evaluation of CB-1158 as a single agent and in~     combination with immune checkpoint therapy in patients with advanced/metastatic solid~     tumors.~   "
11661|NCT02904525|"~     Despite maximal safe surgery followed by combined chemo-radiation therapy, the outcome of~     patients suffering from glioblastoma (GBM) remains extremely poor with a median survival of~     15 months. Hence, new avenues have to be taken to improve outcome in this devastating~     disease. Given their intracerebral localization and their highly invasive features, GBM pose~     some specific challenges for the development of adequate tumor models. Orthotopic xenograft~     models directly derived from the tumor of a patient might represent an attractive~     perspective to develop patient-specific targeted therapies. This approach remains however to~     be validated for GBM as it offers specific challenges, including the demonstration that the~     properties of xenograft models validly represent treatment relevant features of the~     respective human tumors.~      In this innovative project the investigators aim to compare and validate an approach of~     paired human GBM and respective derived orthotopic xenografts in the mouse brain on the~     levels of radiological behavior and metabolism of the tumors, as determined by high~     resolution MRI of the patients (7T MRI) and the respective orthotopic mouse xenografts~     (14.1T MRI), as well as on the level of the transcriptome, genome, and methylome of the~     original GBM tissue and respective derived xenografts/glioma sphere lines. The data will be~     integrated in multidimensional analyses and interrogated for similarities and associations~     with molecular GBM subtype.~      This pilot project will provide the basis for the crucial next steps, which will include~     drug intervention studies. New promising drugs, tested pre-clinically in the mouse~     orthotopic xenograft models established here using the radiologic/metabolic/molecular~     procedures described for this project, will be taken into patients in phase 0 studies. GBM~     patients will receive radiologic/metabolic follow-up using high resolution MRI under drug~     treatment, followed by resection of the tumor and subsequent acquisition of molecular data.~   "
11662|NCT02904512|"~     Several observational studies have shown that uncontrolled hyperglycemia in hospitalized~     patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated~     with prolonged length of stay, increased mortality and an increased incidence of infections.~     Randomized clinical trials in both the critical and the non-ICU settings have shown that by~     improving glucose control there is a decrease in the incidence of infections, length of stay~     and inpatient health care costs.~      Continuous glucose monitoring (CGM) systems have evolved as useful devices providing~     excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect~     glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose~     measurements to a receiving device that reads out average glucose levels every couple of~     minutes.~      In this clinical trial the investigators propose to examine the clinical use of CGM in~     hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric~     values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2~     (DM2)..~   "
11663|NCT02904499|"~     Public health surveillance models, previously used for the ongoing detection of occurrence~     of rare events, could be used to reinforce existing pharmacovigilance systems. These models~     have not been previously used for Adverse Drug Reaction (ADR) detection in~     medico-administrative databases. DABISURV research project focuses on a new anticoagulant~     therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF).~     This drug is at high risk for severe ADR and requires thus careful pharmacovigilance~     monitoring.~      Primary objective is to compare the results of ongoing surveillance models to detect~     hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the~     results obtained from the analysis of a cohort of patients with AF under the same treatment.~   "
11664|NCT02904486|"~     The purpose of this study is to Effectiveness of Modified Health Belief Model Based~     Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.~   "
11665|NCT02904473|"~     This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of~     the GROWell diet intervention. The objective of this study is to determine whether the~     GROWell intervention can help transition women from consuming a Western diet to consuming a~     prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats,~     lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in~     dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow~     up visit at 37 weeks gestation.~      The GROWell intervention is a mobile health technology that uses interactive text messaging~     and dietician coaching calls, and may be effective in transitioning pregnant women from a~     Western to a prudent diet during an approximately 6 month intervention period. GROWell~     results will be measured against an Attention Support Control (ASC) arm, where participants~     will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC)~     arm, where participants will not receive text messages or study coaching.~      Results from this study will be used to support a grant submission for a larger study,~     aiming to investigate the GROWell intervention and prudent diet consumption as preventatives~     against postpartum depression.~   "
11666|NCT02904460|"~     The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a~     light and cooperative sedation as soon as possible in order to decrease the period of~     mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the~     referential hypnotic in this case with a reduction of the morphine-type use.~      DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study~     is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for~     adults, to describe the receivers of DEX and to report the procedure of this new molecule.~   "
11667|NCT02904447|"~     The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th~     toes and the metatarsal distal caput in patients who have had surgery with a partial~     proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.~      Also, to examine these variables and compare them to the totalt range of motion and pain, to~     find out if the measured pedobar pressure can be used identify the well treated patient and~     the poorly treated patient.~      The pedobar pressure gradients will be compared with a control group with healthy feet.~   "
11668|NCT02904434|"~     Voriconazole has better response rates, improved survival and less adverse side effects~     compared to other drugs for the treatment of invasive fungal infections making it a~     desirable therapeutic option for children. However, dosing is unpredictable in children and~     this leads to therapeutic failure. This study aims to understand the physiological~     differences between children and adults that leads to therapeutic failure of voriconazole in~     children.~   "
11669|NCT02904421|"~     The study aimed to:~        1. To investigate and compare the changes in bone mineral density (BMD), trabecular bone~          micro-architecture, bone strength, and curve severity at a mean of 6 years longitudinal~          follow up in AIS girls with low bone mass between Group A and B:~             1. Group A: subjects followed at a mean of 4 years after completion of 2-year calcium~               and Vit-D supplementation and~             2. Group B: subjects without calcium and Vit-D supplementation~        2. To evaluate the correlation between changes in BMD, trabecular bone micro-architecture,~          and bone strength documented in Objective 1 with changes in serum bone turnover markers~   "
11675|NCT02904330|"~     This study is the first time that K1-70 will be administered to humans. The principal aim of~     this study is to obtain safety and tolerability data when K1-70 is administered as an IM~     injection to subjects with Graves' disease.~      Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction~     of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium~     antagonists may be used to control some of the symptoms of hyperthyroidism.~      K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo~     diagnostic and therapeutic tools for the management of patients with Graves' disease,~     patients with thyroid cancer and patients who would benefit from controlling receptor~     activity.~   "
11676|NCT02904317|"~     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with~     an off-label use of oral misoprostol (OM).~      Design: Pair-matched case-control study.~      Setting: Tertiary-care academic centre in Germany.~      Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.~      Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a~     consecutive series of 69 women was compared with induction using oral misoprostol in a~     pair-matched cohort.~      Main outcome measures: The primary outcomes were the time from induction to delivery and the~     caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal~     scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar~     score.~   "
11677|NCT02904304|"~     National clinical trial, phase III, multicenter, randomized, prospective, double-blind,~     parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged~     equal or more than 18 years will be randomly allocated to one the drug group or placebo~     group.~   "
11678|NCT02904291|"~     Bariatric surgery changes the anatomy of the gastro-intestinal tract. Little is yet known~     about how the patients' new physiology may alter the pharmacokinetics of medication. Changes~     in biological availability of medication may have implications for the patients' health in~     the years following surgery.~   "
11679|NCT02904278|"~     The purpose of this study is to collect and compare information on how and when adolescent~     heart transplant recipients take their prescribed medication. The investigators want to find~     out if regular use of 'an app' on cell phones, called the Teen Pocket PATH (TPP), can help~     adolescents take their medication according to their prescribed dosing schedule. This may~     then help reduce complications of transplant, such as rejection. The investigators also want~     to find out if how adolescent heart transplant recipients take their medications affects the~     development of antibodies in their blood. Antibodies are small proteins in the blood that~     may develop after heart transplantation, and which can sometimes damage a new heart.~   "
11680|NCT02904265|"~     The purpose of this study is to compare the effectiveness of the medications acetazolamide~     and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner~     syndrome (LKS).~   "
11681|NCT02904252|"~     The primary objective is to assess the prevalence and genotypes of HCV infection in~     thalassemia major and thalassemia intermediate patients who have received blood transfusion~     in the Department of Medicine, Faculty of Medicine Siriraj Hospital.~      The secondary objective is to identify the effect of HCV infection as well as the risk~     factors of advanced liver disease and liver cirrhosis in these patients~      The third objective is to identify the role of serum HA level and fibrotest in the~     prediction of cirrhosis in these patients.~   "
11682|NCT02904239|"~     New technical developments make ultra-fast non-electrocardiogram (ECG) triggered scan~     acquisition with a high temporal resolution possible, which can be used for the evaluation~     of cardiac pathologies on a standard thoracic Computed Tomography (CT) scans.~      Current studies have shown that it is possible to assess the heart and it's coronary~     arteries on standard ultra-high pitch thoracic CT, which could result in incidental or new~     cardiac findings. However, to be able to perform a complete cardiopulmonary assessment on a~     thoracic CT scan, the injection protocol and bolus tracking settings could be optimised for~     both aortic and pulmonary vasculature (e.g. sufficient attenuation in pulmonary arteries,~     pulmonary trunk and ascending aorta).~      Therefore, the aim of the study is to evaluate the presence and extent of coronary artery~     disease, valvular morphology and calcification, pericardial abnormalities, and cardiac size~     on a standard ultra-high pitch thoracic CT-scan with individualised injection protocols.~   "
11683|NCT02904226|"~     JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of~     JTX-2011 alone or in combination with a fixed dose of nivolumab in subjects with advanced~     solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RP2D), as well as to evaluate preliminary efficacy.~   "
11684|NCT02904213|"~     An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine~     ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as~     a 3-dose series, interval for each dose is 4 weeks~   "
11685|NCT02904200|"~     The primary objective of this investigation is to evaluate changes on Peri-Wound skin from~     baseline to termination when using two different wound dressings~      The secondary objectives are to evaluate:~      •pain before and during and after dressing removal from baseline to termination~   "
11686|NCT02904187|"~     The primary objective to this study is to describe bilateral auditory information processing~     in profoundly deaf patients with bilateral cochlear implants compared with normal hearing~     patients. Assumption used is that due to the central consequences of bilateral deafness on~     binaural auditory information central processing, time between activation of the two~     cochlear implants is a decisive factor in bilateral implantation compared to unilateral~     implantation~   "
11687|NCT02904174|"~     Malnutrition, risk of falls and medication incidents are commonly faced by the older adults.~     This study aimed to provide health education to community-dwelling older adults and to~     assess the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall~     prevention, drug management and healthy eating habits.~   "
11775|NCT02903017|"~     Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments.~     Although new drugs and endoscopic techniques were easily applied in various settings in this~     condition, the role of local administered therapies such as antifibrinolytic agents remain~     unclear. The investigators aimed to compare standard therapy (proton pump inhibitors,~     endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in~     upper gastrointestinal hemorrhage in a double-blind, randomized trial.~   "
11688|NCT02904161|"~     To address the challenges of isolating and analyzing rare cells, this study aims to validate~     technical diagnostic instrumentation, tests, protocols and analysis to correlate the number~     of circulating tumor cells present in whole blood for predicting cancer prognosis and~     treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients.~     Blood samples will be collected from these patients at regular intervals as determined by~     their doctors. The patient's disease progression will be monitored over the lifetime of this~     study. The specific aims are to isolate, enumerate and analyze the number of circulating~     tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging~     techniques. Investigators will also use this study to optimize diagnostic instrumentation,~     test protocols and downstream CTC analysis. Investigators may also correlate the results of~     these tests with the prognosis of the patients as well as any clinical evidence (e.g. from~     radiological imaging scans). While investigators focus on prognosis in this study, these~     correlated tests potentially may also be valuable in future studies for early diagnosis and~     monitoring of cancer.~   "
11689|NCT02904148|"~     Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these~     complications is shoulder pain which affects about 35 to 70% of cases. The medical care of~     this complication is critical because it affects the patient's quality of life and also~     hinders participation in rehabilitation sessions slowing the recovery of independence in~     activities of daily living.~      Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his~     attitude pronounced lateral rotation. But no data to confirm that passive mobilization~     reduce shoulder pain.~      Because no data available to permit us to determine the sample size we set-up this~     preliminary study to check if efficiency found in these preliminary data are consistent with~     an estimable real efficacy in a randomized trial feasible.~   "
11690|NCT02904135|"~     To address the challenges of isolating and analyzing rare cells, this study aims to validate~     the instrumentation, the test protocols, and the analysis of patient's outcome to show the~     instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In~     order to facilitate the validation process, investigators will only focus on metastatic~     patients for whom CTCs supposedly present at higher abundance. Investigators propose to~     enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from~     these patients before they start any new line of therapy as determined by their doctors. The~     specific aims are to isolate, enumerate and analyze the number and/or molecular information~     of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging,~     and molecular profiling techniques. Investigators will use this study to optimize diagnostic~     instrumentation, test blood processing protocols and CTC analysis algorithm. During this~     study investigators will collect patients' clinical information related to cancer, as well~     as the patients' survival status to validate the system's prognosis ability.~   "
11691|NCT02904122|"~     In this study we want to compare a dental diagnose during face to face consultation vs~     remote consultation with telemedicine device.~   "
11692|NCT02904109|"~     The purpose of this study is to investigate the effects of the eNOS activating agent~     triflusal on episodic memory and cognitive functions in participants under chronic stress.~   "
11693|NCT02904096|"~     The primary objective of this study is to evaluate the safety of Radiesse implantation for~     very severe volume loss in the dorsum of the hand at 6 months after treatment.~   "
11694|NCT02904083|"~     Bipolar disorders are common psychiatric disorders characterized by severe and recurrent~     symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods~     characterized by persistent residual symptoms, impaired functioning and quality of life. In~     addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide~     and a high frequency of somatic comorbidities. Poor adherence is one of the major factors~     influencing the course of the disorder and one of the causes of ineffective treatments.~     Considering that between 20 and 60% of patients with bipolar disorder have problems with~     adherence. Adherence is modulated by a number of socio-demographic, clinical and~     neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition,~     studies have shown that the reasons attributed to poor adherence are different depending on~     whether questioning patients or healthcare professionals. This fault diagnosis, assessment~     of the causes and fit into the reasons associated with poor adherence is an aggravating~     factor of the problem. However, this factor seems modifiable by better training of~     professionals. A team from Newcastle University in England has developed a training program~     for all health professionals to improve the diagnosis and understanding of compliance issues~     in bipolar patients and provide simple tools to fight against patients with this problem.~     The investigators assume that this training will improve medication adherence among~     outpatients by trained professionals.~   "
11695|NCT02904070|"~     Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many~     preventive measures and use of tocolytic therapy, the incidence of premature births has not~     decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was~     still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth~     is related to spontaneous premature labor layout without rupture of amniotic membranes,~     called threat of premature birth.The threat of premature birth, defined by the combination~     of cervical modifications and regular and painful uterine contractions from 22 weeks of~     amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in~     pathological pregnancies services. But all threat of premature delivery situations do not~     cause premature delivery. In our service, only 30% of patients hospitalized for threat of~     premature delivery give birth prematurely in accordance with published international data.~     The diagnosis of threat of premature delivery is difficult and it is still not possible to~     differentiate a false labour of a real labour.~      Currently the diagnosis of threat of premature delivery in routine is based on the~     combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks~     specificity.~      In absence of prognostic tool for predicting more reliably the risk of premature delivery in~     situation of threat of premature delivery, the medical cares are maximalist.:~     hospitalization, conducting paraclinical investigations, prescription of tocolytics~     treatments and conducting antenatal corticotherapy. it seems particularly necessary to~     identify more efficient prognostic criteria that the clinic and ultrasound for judging the~     severity of threat of premature delivery in other words to predict the risk of premature~     delivery to adapt and adjust the care of patients after diagnosis of threat of premature~     delivery.~   "
11696|NCT02904044|"~     TsColEPS aims at identifying individual determinants of sport injuries during physical~     activity lessons in secondary school at reunion Island.~   "
11814|NCT02902510|"~     This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.~   "
12037|NCT02899611|"~     Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV)~     delivery of valproate using an implantable drug pump system. The dose of valproate will be~     escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum~     tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label~     evaluation period (non-blinded).~   "
11697|NCT02904031|"~     -  Few data are available about the treatment of metastatic colorectal cancer (mCRC)~          elderly patients with anti-EGFR agents in combination with chemotherapy. Up today, most~          of the available data are from retrospective/post-hoc analyses, making them difficult~          to translate to everyday clinical practice.~        -  FOLFOX plus panitumumab is a standard first-line therapy option for RAS wild-type~          untreated mCRC patients. Slight adjustments in chemo-dosage are commonly applied in~          routinary practice to elderly patients, but those modified schedules have never been~          prospectively tested.~        -  In elderly patients, a reasonable upfront treatment is a fluoropyrimidine-based~          monotherapy plus bevacizumab, irrespectively of the molecular status of RAS.~        -  BRAF mutation is a strong negative prognostic factor associated to advanced age, poor~          performance status (PS), extended and aggressive disease and is associated to a lack of~          benefit from anti-EGFR moAb.~        -  Clinical definition of elderly (over 70 years old) CRC patients that may deserve a more~          or less intensive combination therapy is still debated. The cut-off of 75 years old~          combined with ECOG PS assessment is a reasonable approach for clearly defining~          candidates to different approaches31.~        -  Several geriatric screening tools have been used to identify patients with a geriatric~          profile potentially predicting for overall survival and risk of toxicity. The G8~          screening tool has been validated in cancer patients showing the strongest prognostic~          value for overall survival; the CRASH score is able to stratify patients according an~          estimated risk of treatment-related toxicities.~      On the basis of these considerations, the investigators designed the present randomized~     phase II trial of first-line therapy panitumumab in combination with simplified FOLFOX or~     with 5-fluorouracil, in previously untreated elderly patients with RAS and BRAF wild-type~     unresectable mCRC.~   "
11698|NCT02904018|"~     In this study we want to evaluate the oral care pathway after an oral teleconsultation.~   "
11699|NCT02904005|"~     This study aims at identifying predictors of suicidal behaviors in depressed subjects.~     Investigators will first compare demographic, clinical, and biological features of depressed~     recent suicide attempters (within one week) and depressed subjects without lifetime history~     of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of~     attempting suicide during a one year follow-up. A thorough evaluation of these patients will~     allow to identify the factors associated with suicidal risk and develop a simplified risk~     score that could be used in clinical settings to improve our practice.~   "
11700|NCT02903992|"~     The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to~     various negative health outcomes such as impairment of physical performance and disability.~     Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of~     the frailty syndrome. However, for clinical use and for treatment and prevention strategies,~     reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are~     indispensable.~      This topic has recently been addressed by the Foundation for the National Institutes of~     Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below~     which older adults had a higher likelihood of clinically relevant weakness reflected by low~     grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512~     women) was found to be associated with increased likelihood for mobility impairment.~      In this context, the aim of this study is to study the prevalence of sarcopenia in a sample~     of community-dwelling frail and pre-frail older adults.~   "
11701|NCT02903979|"~     In front of a lack of evidence to determine the best treatment for deep cavitated carious~     lesions, the search for an effective restorative technique, which results in a least~     possible discomfort to patients, and reduce the time needed for the restorative treatment,~     if becomes relevant. The objective of this randomized clinical trial to evaluate the~     efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to indirect~     pulp capping with calcium hydroxide cement associated with high viscosity glass ionomer~     cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of~     treatment on quality of life, cost of procedures, the perception of parents / carers,~     patients and operators, and satisfaction with the techniques evaluated. Children with 4 to 8~     years will be selected randomly at the Clinic for Children at the University Ibirapuera of~     Dentistry. 166 teeth will be randomized into two groups: (1) indirect pulp capping performed~     with calcium hydroxide cement, followed by restoration with HVGIC and (2) HVGIC restoration.~     The restorations will be evaluated after 6, 12 and 24 months by two trained examiners~     blinded to the treatments. The efficacy of each treatment is measured by four main outcomes,~     which are: (1) criteria related to the effectiveness of the restorative treatment with HVGIC~     compared to indirect pulp capping with calcium hydroxide cement, (2) criteria focused on the~     patient, (3) cost-effectiveness, (4) perception of parents and operators about the~     treatments. For comparison between the two groups will be used the Kaplan-Meier survival and~     the long-rank test. Cox regression is performed the assessment of the influence of some~     other variable results. For all analyzes, the significance level is set at 5%.~   "
11702|NCT02903966|"~     This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1)~     kinase inhibitor, in subjects with active ulcerative colitis (UC).~      The primary objective will be to investigate the safety and tolerability of repeat oral~     doses of GSK2982772 60 mg or placebo twice daily for 42 days (Part A) followed by open label~     with GSK298772 60 mg twice daily for 42 days (Part B). In addition to pharmacokinetics (PK),~     a number of experimental and clinical endpoints will be employed to obtain information on~     the pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no~     formal hypothesis will be tested, these endpoints will enable a broader understanding of the~     mechanism of action and potential for clinical efficacy of GSK2982772 in UC.~      Within 30 Days of screening visit, subjects will be randomized to receive either GSK2982772~     60 mg or placebo orally twice daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study.~     Subjects who complete the Part A study will move to open label Part B study to receive~     GSK2982772 60 mg twice daily for an additional 42 Days (6 weeks). After the open label (Part~     B) treatment period, subject will enter the Follow-up period which lasts for 28 Days (+/- 3~     Days) post the last administration of study medication. The total duration of participation~     in the study will be approximately 20 Weeks from screening to the last study visit.~   "
11703|NCT02903953|"~     The very most part of clinical research in France takes place in teaching hospitals.~     Advantages to develop it in others hospitals are numerous: access to innovative treatments,~     improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and~     reduced selection bias. The objectives of the study are to report the current situation of~     clinical research outside of teaching hospitals in France.~   "
11704|NCT02903940|"~     The purpose of this study is to evaluate the application of Negative Atrioventricular~     Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT)~     patients.~   "
11705|NCT02903927|"~     The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601~     PY for the monocular uncorrected distance visual acuity and compare it to the reference~     monofocal IOL Acrysof IQ SN60WF.~   "
11707|NCT02903901|"~     To test the efficacy of melatonin compared to placebo in preventing post-operative delirium~     and reduction in intensity or duration of delirium in individuals 65 years of age and older~     who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).~      Biomarkers may play important roles in the detection, prediction and management of delirium~     especially in frail elderly individuals. Predictive biomarkers may help characterize an~     individual's susceptibility to delirium and thereby help specialized treatment, care and~     management of such individuals during their hospitalization. They may also help predict~     treatment response to a specific modality and help in selection of such modality. Recent~     studies performed in the UK and published in 2011 have measured plasma cholinesterase~     activity and determined that these levels were lower in patients who developed delirium~     compared with remaining subjects. Other studies have indicated that CRP may also have a role~     in delirium prediction as they have found that CRP measured on admission to an ICU had~     predictable changes that occurred within 24 hours that in turn were predictors of delirium.~     One the aims of the study is to compare the predictive and treatment response values of~     groups of biomarkers that have been hypothesized to be of predictive value.~   "
11708|NCT02903888|"~     A cross-sectional, observational multicenter study to assess the reasons for choosing the~     3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study~     will be conducted in standard clinical practice conditions at public and private gynecology~     clinics and during a single study visit.~      Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD~     as their contraceptive method will be included in the study.~   "
11709|NCT02903875|"~     The therapeutic education of patients and their close relations is, as yet, poorly developed~     in France in the field of oncology, in particular for cancers of the upper aerodigestive~     tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with~     radiotherapy remains a reference treatment for advanced stage cancers. This mutilating~     surgical procedure has a major impact on the patient's life, due to its physical and~     functional sequelae. Its psychosocial consequences are also important, owing to the~     biographical disruption and the identity-related metamorphoses associated with illness and~     its treatment, which alter the quality of life not only of patients, but also of their close~     relations. Currently, care for laryngectomised patients consists essentially in informing~     and educating them on certain technical procedures during hospital admission. New voice~     education can be a long process and often involves the intervention of a speech therapist,~     who serves as the link between the patient and the hospital care team. These healthcare~     modalities often insufficiently account for the social, environmental and personal factors~     that interact in health-related problems.~      The aim is to design, implement and evaluate a patient therapeutic education (PTE)~     programme, for laryngectomised patients and their close relations, aimed at improving their~     quality of life.~      The research will be conducted over three phases:~      The first phase, referred to as the pilot phase, will include exploratory, observational~     and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy~     on the quality of life of patients and their close relations, the strengths and weaknesses~     of current practice in patient support and the needs expressed by the players involved~     (patients, relations, professional carers). This analysis will be conducted via interviews~     with patients and their close relations and focus groups with the healthcare professionals~     involved in patient care and support (hospital and independent). This first phase will~     enable the pluridisciplinary design of a therapeutic education programme for laryngectomised~     patients and their close relations which will be tested in the study's principle~     coordinating centre. The method defined thus is in keeping with quality criteria set by the~     HAS specifying that the PTE should focus on the patient, be scientifically justified, and be~     developed by a pluridisciplinary group reuniting representatives of patients or patient~     associations.~      The second phase, referred to as the prospective intervention replication phase, aims at~     evaluating the programme's transferability and quality in three centres. The centres~     participating in this second phase already have experience in the development of PTE~     programmes and will be involved in the workgroup entrusted with the design of the PETAL~     programme during phase 1.~      The third phase, referred to as the randomised multicentric comparative intervention~     phase, should enable us to assess the benefits of the developed PTE programme on the quality~     of life of patients and their close relations.~      This is a pluridisciplinary study via which we hope to improve the quality of life of~     laryngectomised patients and their close relations through the design and the sustainable~     deployment of an innovative PTE programme in France and Belgium. This project also aims at~     reinforcing town-hospital links to improve help, follow-up and support for patients and~     their close relations, as well as dialogue between healthcare professionals.~   "
11710|NCT02903862|"~     The purposes of this study are to (1) track dementia caregiver health indicators over 12~     weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile~     messaging and assessment applications) to determine if the intervention improves caregiver~     health and (2) obtain feedback from caregivers to inform on the design of future~     interventions.~   "
11711|NCT02903849|"~     The investigators are interested in using personalized, self-motivating messages to motivate~     people to exercise more.~   "
11712|NCT02903836|"~     Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral~     Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial~     Pneumonia (CABP) in Adults~   "
11713|NCT02903823|"~     The goal of this pilot study to determine whether there is a significant therapeutic~     advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the~     spine. It is also a goal of this pilot study to determine whether the origin of spasticity~     influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located~     in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study~     the impact of catheter location on the reduction in spasticity within a group of patients~     who are scheduled for ITB trial.~   "
11714|NCT02903810|"~     Clinical study of CD19 CAR-T in the treatment of blood and lymphatic system tumor has been~     achieved a breakthrough. The main solution in clinical research is to use CD19 CAR-T~     infusion alone. Because of the heterogeneity of the tumor, the patient often carries tumor~     cells with CD19 deficient but other positive target antigens (such as CD22). Specifically~     removal of CD19 positive tumor cells in CAR-T treatment, CD19 negative tumor cells or tumor~     cells which carry other target antigens would amplify with extra free space released at the~     same time, resulting in the relapse of tumors of heterogeneities. In order to effectively~     control the recurrence, CAR-T treatment scheme specific for several target antigens was~     presented and verified. However treatment with the sequential infusion of different target~     specific CAR-T cells, the window period between two times infusions may be the opportunity~     for the tumor recurrence of heterogeneity; and bispecific CAR-T has also been reported only~     one CAR can be fully functioned. In order to avoid these problems, this topic puts forward~     for the first time in the international with a treatment scheme of an equal amount of~     infusion of CD19-41BB and CD22-41BB two Car-T in the treatment of refractory hematologic~     malignancies. We expect the treatment is more effective in eliminating tumor burden, and~     also can inhibit the recurrence of tumor heterogeneity at the same time.~   "
11715|NCT02903797|"~     The purpose of the study is to determine serum irisin hormone levels an its relation between~     endometrial hyperplasia~   "
11716|NCT02903784|"~     According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly~     progressive, infiltrating the central nervous system, mainly affecting young adults.~      This surgery should nevertheless be conducted in awake condition to achieve two conflicting~     goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of~     functional structures. So awake after opening the skull, the patient undergoes a series of~     preoperative tests, administered by a speech therapist present in the operating room. This~     procedure allows the neurosurgeon to establish an individual functional brain mapping in~     real time, through the observation by the SLP of the patient's answers to direct electrical~     stimulation applied to the cortical and sub-cortical. This support is based on the~     extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive~     lesion. To ensure the patient the highest achievable load should increase our understanding~     of brain function, including the neural bases of language, glioma grade 2 is predominantly~     localized functional area of language.~   "
11717|NCT02903771|"~     The main purpose of this study is to determine the safety and feasibility of weekly~     intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian~     cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine~     the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy~     or a combination therapy.~   "
11718|NCT02903758|"~     Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more~     different malaria parasites lead to complex and potentially harmfull therapeutic problems.~     The aim of the study was to look at malaria smears between 2000 and 2008 and determine using~     PCR the frequency of mixed infections, and their distribution in the terrtory of French~     Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax.~     The Maroni river where Duffy negative populations live was largely devoid of vivax~     infections. These results suggest that mixed infections are frequent in french guiana except~     on the Maroni river which leads to practical implications for clinicians facing a patient~     with clinical malaria.~   "
11719|NCT02903745|"~     French Guiana is the French territory where the prevalence of HIV is highest. in order to~     determine the knowledge attitudes, beliefs, and practices among the target group of~     teenagers attending the public school system a survey was conducted in 2011. schools and~     classrooms were randomly selected, and a structured questionnaire was administered.~     Descriptive statistics were obtained and multivariate logistic regression was used to~     determine predictors of main outcomes such as age at first sex.~      the results will be used to guide prevention of HIV and sexually transmitted infections~     though the school system.~   "
11720|NCT02903732|"~     The objective of the autism registry is to estimate the prevalence of autism in French~     Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the~     prevalence of comorbidities, and to determine the theoretical and actual orientation of~     these children regarding care and education in a territory with significant structural~     deficits relative to mainland France. The outcomes of this registry will be to guide~     decision makers in their funding priorities to improve, screening, diagnosis, care and~     education for children on the autistic spectrum~   "
11721|NCT02903719|"~     The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block~     can reduce the postoperative pain in the shoulder after liver resection. The intervention is~     directed postoperative to the patients experiencing novel right sided shoulder pain.~   "
11722|NCT02903706|"~     Malaria is the most widespread parasitic illness in the world, and it is endemic to Guiana.~     Although the number of cases has decreased since 2005, sources of infection still remain,~     particularly within illegal gold mines. These malaria carriers/sufferers often use~     self-medication to deal with malaria symptoms, resulting in a risk of resistance to~     anti-malarial treatments, and particularly to artemisinine. The mobility of this population~     across the Guiana Shield increases both the risk of malaria spreading and the resistance of~     this illness to treatment in the region, and puts the population at risk of new outbreaks of~     this disease despite the great efforts put into anti-malarial policy in this region.~      Fighting malaria within this population is therefore a dual public health challenge: on the~     one hand, make it possible for the WHO to eliminate malaria from the Guiana Shield by 2017,~     on the other to limit resistance to artemisinine in this region. However, Guiana's~     particular context - namely the illegal status of gold mines and the difficult geographical~     access, the Harpie military operations, the illegality of carrying out malarial diagnosis~     tests and treating cases without the presence of a health professional - prevents us from~     achieving this goal using the same tools as our neighbours in Suriname, whose  Looking for~     Gold, Finding Malaria  programme was a success.~      A better understanding of the malarial epidemiology in this population will enable us to~     propose innovative, more adapted measures to combat malaria within these guyanese~     populations. This is an transversal, multicentric observational study.~   "
11723|NCT02903693|"~     Given that cervical cancer is the second most frequent cancer among women in french guiana~     the aim of the study was to determine the screening rate among women living in French~     Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening~     rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100~     women-years. between 2006 and 2011 54% of women were screened. These baseline figures will~     allow to evaluate present efforts to increase the screening rate for this frequent cancer in~     French Guiana.~   "
11724|NCT02903680|"~     Background: Headaches is one of the most common complaints of children in the ED and the~     treatment of pediatric migraine is largely based on extrapolation data from adult studies,~     limited pediatric trials, clinical experience and expert consensus. Despite the fact that~     dexamethasone has already been proven effective to reduce recurrence and is currently used~     in treating adults with migraine, no studies have looked at its use in the treatment of~     childhood migraine where relapse rate of about 50% are described in the 48h following~     successful treatment in the ED.~      Objective: To examine the effectiveness of parenteral dexamethasone at preventing migraine~     recurrence in children and to study the risk factors for migraine relapse after discharge~     from the ED.~      Methods: This a randomised, double-blind, placebo-controlled clinical trial among all~     children 8 to 17 years of age with a presumptive diagnosis of acute migraine and treated~     with a standardized protocol in the ED of the CHU Ste-Justine, a tertiary care pediatric~     hospital. After the parenteral administration of prochlorperazine or metoclopramide and~     diphenhydramine, the patients were randomised to receive either dexamethasone or a placebo.~     They were excluded from the intervention if they had a known allergy or absolute~     contraindications to receiving parenteral corticosteroids, if they were already on a~     corticosteroid regimen or if they did not respond to the initial abortive migraine therapy.~     All included patients were discharged on a 48-hour course of naproxen and with a headache~     diary to fill out and return. The primary outcome was the incidence of relapse in the 24-48h~     following discharge from ED. The secondary outcomes evaluated were the mean level of pain,~     the use of rescue medication after ED discharge, the return rate to the ED or the visit to a~     health care professional within 7 days including hospitalisation. The associated symptoms,~     the adverse events after parenteral corticosteroids and the risk factors for migraine~     relapse were also evaluated. A telephone follow-up was made to ensure the headache diary was~     completed and returned.~   "
11725|NCT02903667|"~     An open, prospective, randomized, multicenter study focused on the ridge diminution in case~     of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma,~     Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).~   "
11726|NCT02903654|"~     Given the high incidence of Pompe's Disease in French Guiana (100 times higher than in~     mainland France) the aim is to determine the prevalence of heterozygotes among women having~     just delivered in French Guiana who accepted that their newborn child enters the depipomp1~     study. In these women the specific mutations p.Gly648Ser and p.Arg854X will be sought using~     PCR in order to calculate the prevalence of these mutations and estimate the risk factors~     associated with them in order to improve genetic counselling.~   "
11739|NCT02903485|"~     This study aims to demonstrate that presurgical assessement of patients' risk factors and~     surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's~     care, concerning the rate of complications in cataract surgery with topical anesthesia.~      The nurse performs the triage of patients based on a chart of risk factors assessment. The~     triage, according to the presence or not of risk factors, leads to patients' care by an~     anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for~     surveillance during surgery) or to patients' pre-surgical assessement and surveillance~     during surgery both performed only by nurses.~      In the control group, all patients are taken care of by an aesthetic team, with medical pre~     surgical assessement and surveillance during surgery both performed by anesthetic nurses.~   "
11853|NCT02902003|"~     The Parenting Center (TPC) offers the Empowering Families program, which integrates a~     relationship education curriculum (Family Wellness) into a comprehensive set of services~     that includes case management, employment services, and financial coaching. The evaluation~     will test the effectiveness of offering relationship skills education services with a robust~     economic security component to low-income couples raising children.~   "
11727|NCT02903641|"~     Malnutrition accounts for nearly half of child deaths worldwide. Children who are~     well-nourished are better able to learn in school, grow into more physically capable adults,~     and require less health care during childhood and adulthood. Moreover, it is difficult to~     make up for poor childhood nutrition later in life. I present here the proposal for an~     intervention that builds on a larger study in Ethiopia and will generate insights into the~     importance of behavioral factors related to persistent malnutrition in low-income settings,~     allowing for more targeted, cost-effective interventions in the future.~      Existing data from the study region, Oromia, Ethiopia, suggest that many mothers know how to~     correctly respond to a hypothetical situation where a young child exhibits poor growth. On~     the other hand, however, mothers frequently appear unaware about their own children's growth~     deficiencies. Together, these facts suggest that false beliefs about the appropriateness of~     a child's physical size are a more likely contributor to malnutrition, rather than a weak~     understanding of how to help a malnourished child.~      The proposed intervention will provide evidence on the relationship between caregiver~     beliefs about child nutritional status and the caregiver's behavior, ultimately analyzing~     how this relationship influences important nutritional choices for young children in a~     setting with limited resources. The study uses a two-by-two randomized trial; the first~     treatment is a cash transfer labeled for child food consumption, and the second is the~     provision of personalized information about the quality of the child's height compared to~     other children like those of the same age and gender in East Africa. Together the two~     treatment arms will provide evidence about the relative importance of behavioral versus~     resource barriers to improved nutrition. Better understanding of the interaction between~     these key factors is essential in addressing one of the foremost health issues facing~     developing countries today.~   "
11728|NCT02903628|"~     The purpose of this study is to determine whether Eye Health Intervention can obviously~     reduce and delay myopia onset and development and improved the awareness rate of knowledge~     apparently .~   "
11729|NCT02903615|"~     Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the~     beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency,~     whereby blood glucose levels rise and diabetes develops. When there is severe insulin~     deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin~     replacement therapy; dietary intervention is a also cornerstone of glucose management.~      The Optimise Diet is a multi-pronged diet based on best health principles: to minimise~     blood glucose rises after eating, reduce the immune cells involved in destruction of the~     insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In~     this study, its effects will be compared to the Standard Diabetes Diet that is currently~     recommended in Australia and internationally.~   "
11730|NCT02903602|"~     The purpose of this study is to determine the effectiveness of an innovative methodology for~     training Community Health Workers that will improve their effectiveness in educating mothers~     to adopt best practice health behaviors in the home.~   "
11731|NCT02903589|"~     The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which~     lies between French Guiana and Surinameaim of the study is to determine the knowledge,~     attitudes, behaviours, and practices on HIV in the population living along the French bank~     of the Maroni border. Descriptive statistics are computed from the tabulation of answers to~     a structured questionnaire. Multivariate logistic models were computed to determine~     predictors of key outcomes. These data will help taylor prevention intervention in this very~     particular area.~   "
11732|NCT02903576|"~     This study is a Phase I/II , open label,non randomized, prospective study to determine the~     safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub~     retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub~     retinal space,~   "
11733|NCT02903563|"~     The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a~     population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A~     standardized questionnaire was administered face to face to sex workers. Analysis of the~     questionnaires led to descriptive statistics. Multiple logistic regression models were~     computed to determine the predictors of condom use.~   "
11734|NCT02903550|"~     Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin~     pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution~     consists in a destruction of the ossicles as well as their possible spread through the base~     of the skull into the brain. Surgical treatment is required to prevent infectious or~     functional complications. A recurrence after surgery occurs in approximately 10% of patients~     and rarely affects initial site. Surgical treatment is the only care option for recurrent~     cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are~     seen. Temporal bone CT is performed prior to surgery for added information on bone erosions~     especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high~     anatomical resolution and complex anatomy, temporal bone CT is usually displayed with~     Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .~      Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients.~     Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic~     resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent~     cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI~     sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or~     Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion~     between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise~     the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in~     assessing lesion spread and volume are still unknown and needs further investigations. The~     aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the~     accuracy prior to surgery propectively compared to surgical findings.~   "
11735|NCT02903537|"~     The purpose of this study is to determine the safety and tolerability of the intranodal~     administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and~     pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the~     most appropriate regime for the development of future therapeutic trials.~      To evaluate the preliminary proof of concept by clinical and/or radiological activity and~     immunological markers.~   "
11736|NCT02903524|"~     Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus~     Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy~     in Locally Advanced Breast Cancer Patients~   "
11737|NCT02903511|"~     This study is being done to determine if treatment with metformin, a drug widely used for~     the treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal~     Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly~     decreased kidney function. The study will also evaluate the effects of metformin on kidney~     growth and kidney function.~   "
11738|NCT02903498|"~     The purpose of this study is to evaluate the efficacy and tolerability of the maintenance~     treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced~     gastric cancer.~   "
11854|NCT02901990|"~     This study was aimed to conduct a 3-year perspective study to observe the immunological~     effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated~     population aged 2-7 years，and provide basis for adjusting MMR immunization strategy in~     Jiangsu province, China.~   "
11740|NCT02903472|"~     Changes in the GI microbiota and/or metabolomics have been linked to evolving~     transformations in immune system function and infection rates in experimental SCI in animal~     models. A recent study involving chronic survivors of SCI show distinct GI microbiome~     changes in comparison to healthy controls. GI microbial metabolism of dietary components has~     been causally linked to various health conditions, such as cardiovascular disease,~     infections, which is an ongoing concern for chronic SCI survivors. It is probable that~     alterations of GI microbiota are established acutely after SCI and could subsequently alter~     medical care and impact health outcomes for people living with SCI.~      This project is a pilot study to describe any changes in the GI and urinary tract microbiota~     as they appear over the first year after SCI. When available, data on factors, other than~     SCI, that may impact change in the gut microbiome after SCI will also be noted, including:~        -  the level and severity of SCI,~        -  the time since SCI,~        -  the person's immune profile,~        -  the antibiotic regimen of the individual and time since antibiotic administration,~        -  the incidence and type of infections after SCI and~        -  the person's diet or activities after SCI~   "
11741|NCT02903459|"~     The aim of this study is analyze the relationship between the density of visceral and~     subcutaneous fat and cellulite with the lumbar lordosis degree.~   "
11742|NCT02903446|"~     Bone erosions are a common manifestation and feature of structural damage in severe/chronic~     tophaceous gout. Management of this destructive and often debilitating gout complication has~     focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but~     little attention has been given to prevention or reversal of gout related bone erosions and~     other structural damage to bone caused by gout. Since there is no known effective treatment~     to attenuate or improve structural damage caused by gout, we propose a pilot, controlled,~     proof-of-concept study in which denosumab, an FDA approved medication for the treatment of~     bone loss, will be added to standard ULT in 20 patients with erosive gout.~   "
11743|NCT02903433|"~     Avocados are an excellent source of fiber, potassium, magnesium, and poly- and~     mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns~     and have the potential to improve the cardiovascular disease (CVD) risk profiles of families~     in the United States (US). The proposed research plan will focus on the contribution of~     avocado intake to the reduction in CVD risk of US families, by examining the effects of~     avocado intake on the overall nutritional status of families. Of particular interest is~     establishing these effects in ethnic populations such as Hispanics/Latinos. On average,~     Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This~     6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine~     the impact of avocados on the overall dietary pattern of their families. Future research~     will extend the results of the current trial to a larger sample of ethnically diverse~     families in order to evaluate whether sustained changes occur in nutritional, cardiovascular~     and metabolic health status.~   "
11744|NCT02903420|"~     A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the~     safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model:~     9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic~     dialysis, who are determined by the heart team to be unable to undergo safe open surgical~     therapy and have the benefits of the study valve implantation.~   "
11745|NCT02903407|"~     This study aims to examine the use of protocol directed sedation using the Duke PAD protocol~     with the current sedation medications of propofol or dexmedetomidine compared to the PAD~     protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial~     step toward understanding the best management of sedation in these patients.~   "
11746|NCT02903394|"~     The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI)~     endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe~     will obtain optical measurements from the cervix. These measurements can be used to create a~     map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia,~     and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is~     most likely to occur.~   "
11747|NCT02903381|"~     This research study is evaluating a new drug called nivolumab as a possible treatment for~     smoldering multiple myeloma in order to prevent or postpone development of active multiple~     myeloma.~      - Patients with smoldering multiple myeloma do not have symptoms but are at risk for~     progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell,~     which is an important part of the immune system. Patients with active multiple myeloma~     generally require treatment.~   "
11748|NCT02903368|"~     This research study is studying a combination of drugs called abiraterone acetate and~     ARN-509 as a possible treatment for new diagnosed Prostate Cancer.~      The following interventions will be use in this study :~        -  Abiraterone Acetate~        -  Prednisone~        -  ARN-509~        -  Leuprolide Acetate~   "
11749|NCT02903355|"~     This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical~     trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus.~     The goal of the study is to develop a safe, oral pharmacological agent to augment physical~     hearing protectors for noise exposures that exceed the protective capabilities of ear plugs~     and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees~     during and 22 days after their 11 day weapons training. The primary objective of this study~     is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a~     minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.~   "
11750|NCT02903342|"~     To assess the suitability and user-friendliness of an information leaflet for parents on~     management of fever and febrile illness in children. The purpose of the leaflet is to~     provide evidence-based information for parents regarding fever and febrile illness in~     children.~   "
11762|NCT02903186|"~     The goals of this multi-site clinical trial are to pilot test weekly SMS sent to~     parents/caregivers of infants to improve feeding practices and decrease excessive weight~     gain in infants who are participants of the Women, Infants and Children (WIC) program in~     Puerto Rico and Hawaii. The intervention consists of weekly SMS for 4 months to reinforce~     the feeding messages provided by WIC.~   "
11855|NCT02901977|"~     Randomized double-blind parallel group study in patients with mild-to-moderate hypertension~     to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks~     with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.~   "
11751|NCT02903329|"~     Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting~     approximately 63 million people worldwide. MOH is a potentially treatable condition, and~     there are different opinions among headache specialists concerning the correct treatment~     strategy.~      The study is a prospective longitudinal open-label randomized controlled study comparing two~     detoxification programs conducted in a tertiary headache care center. Patients with MOH are~     either randomized to treatment in program A or program B. In program A, patients undergo~     detoxification without any acute medication during a two months period (complete stop of~     acute medication intake). In program B, patients was allowed to take up to 2 days a week~     with analgesics or migraine medication during the two months detoxification period~     (restricted acute medication intake). Both A and B are out-patient programs, and patients in~     both groups receive patient education, consisting of six lessons, managed by specialized~     headache nurses in collaboration with specialized psychologists and physiotherapists (Figure~     1). All patients are also offered rescue medication (levomepromazine or promethazine) and~     antiemetics, if necessary.~      The need for prophylactic treatment is evaluated individually after 2-month detoxification.~     Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked~     to continuously register headache calendar and to fulfill questionnaires at all the~     follow-up visits. In addition they are asked to fill out questionnaires (Headache~     Under-Response to Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity~     of Dependence Score (SDS), World Health Organization Quality of Life Score(WHO QoL) and~     Dolo-score) at baseline, 2, 6 and 12 months~   "
11752|NCT02903316|"~     The purpose of this study is to determine if extra systoles can be used to predict fluid~     responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft~     (CABG) surgery. As an additional study we will investigate the ability of a mini fluid~     challenge to predict response of a larger volume of fluid.~   "
11753|NCT02903303|"~     This pilot study consists in testing the efficacy of hypnosis as an adjuvant treatment for~     patients suffering from chronic lumbar pain and for whom a facet block is indicated by a~     doctor in the Centre d'antalgie of CHUV (Centre Hospitalier Universitaire Vaudois), where~     this study will take place. 5 to 8 patients will be included in this study. The goals of~     this study are :~        -  Assess the feasibility of such a protocol with more patients~        -  Measure the number of patients necessary to obtain a significant result~        -  Search for possible side effects of the combination of both treatments~      Every patient in this pilot study will undergo 4 hypnosis sessions within 2 weeks before the~     facet block. These sessions will be done with an hypnotherapist formed for this kind of~     treatment.~      Three times during this study, each patient will have a discussion with the co-investigator~     :¨~        -  1st discussion : just before the first hypnosis session~        -  2nd discussion : after the 4 hypnosis sessions and just before the facet block,~          approximately 3 to 4 weeks after the 1st discussion~        -  3rd discussion : 2 to 4 weeks after the facet block~      They will allow to obtain several data :~        -  Pain assessment : intensity, localization, variability, characteristics, effects on~          daily life activities~        -  Anxiety and depression assessment~        -  Expectations assessment : about both treatments and their combination~        -  Efficacy assessment : about both treatments for the patient~        -  Questions about the perceptions of the treatments (prejudice, ...) et possible side~          effects.~      These data will then be analysed (quantitative and qualitative analysis, depending on the~     question type) to fulfill the objectives of the study.~      will include 5 to 8 people suffering from chronic lumbar pain. The procedure consists in two~     steps :~        1. 4 hypnosis sessions as an adjuvant treatment for number 2~        2. a facet block, which is the standard procedure in the Centre d'antalgie in CHUV.~      There will be no control group, so every patient will participate to the hypnosis sessions~     and undergo the facet block. All the procedure of the facet block (including~     contraindications and side effects) are not considered to be part of this study because all~     patients in this study would have had a facet block if they would not participate in it.~      The only data that will be collected are questionnaires about several items (pain, anxiety,~     depression, ...). These questionnaires are filled with the patient at the beginning of the~     study (day 0), before the facet block (between day 14 and day 21) and 2-4 weeks after it~     (between day 28 and day 49). There are quantitative and qualitative questions.~   "
11754|NCT02903290|"~     Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their~     overall prevalence is estimated at 2-4 cases per 100 000 people. These diseases are~     manifested by a static and kinetic cerebellar syndrome characterized by impaired balance,~     coordination, and an ataxic gait. To date, no therapy is available for patients and physical~     therapy is essential and recommended. The evolution of the pathology causes a degradation of~     walking, increased instability and risk of falling. In one year, between 74% and 93% of~     patients reported having fallen at least once. Falls prevention by understanding the~     mechanisms affecting stability is a major issue in the management of these patients~     physiotherapy. The analysis of the literature, we assume that there exists a trio fatigue -~     instability - energy expenditure in which the three parameters would influence each other.~     To date, we do not have data to characterize these interrelationships and their evolution~     over time.~      STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy~     expenditure and changes in instability when walking at one year in patients with cerebellar~     ataxia gene. The secondary objectives are to study, after one year of development, the~     relationship between fatigue, instability, energy consumption, the number of falls, the~     severity of ataxia and quality of life.~      CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration~     of patient recruitment will be 12 months and the total number of patients will be included~     in 15. The duration of participation in this study is 12 months for each patient. The~     anticipated duration of the study is 30 months. Development of the study: Patients included~     will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia~     according Scale for the assessment and rating of ataxia (SARA); measuring the quality of~     life through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue~     perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before~     and after physical activity; quantified analysis of walking on walking track GAITRite® (with~     score calculation FAP and GVI) before and after physical activity; physical activity like~     walking on a treadmill (with measurement of maximal voluntary quadriceps by manual~     dynamometer before and after physical activity to ensure the induction of fatigue). Patients~     will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED,~     Rome, Italy) during walking analyzes GAITRite®.~   "
11755|NCT02903277|"~     The median age of onset of chronic myeloid leukemia (CML) in chronic phase PC is about 60~     years. However CML affects all age groups including 18-25 year olds, called adult-young~     adolescents (AJA). In France, there is no record of CML and especially not for this~     particular population, only a European Register of CML in children up to 18 years has been~     set up under the coordination of Professor Frederic Millot, pediatrics, CHU Poitiers.~     Malignancies diagnosed in this population usually have characteristics, evolution,~     therapeutic strategies with tyrosine kinase inhibitors (TKIs) are a real therapeutic~     revolution with an overall survival very significantly augmented but at present only a~     minority of patients may one day consider a final judgment of treatment. AJA are the most~     exposed patients to the complications, the socio-economic repercussions, professional and~     personal of a very long-term treatment. But there is little data in the literature~     concerning this population. Two studies show that diagnosis of CML presents with poor~     prognostic factors (high skoal), the observed responses are poorer compared to older~     patients but it is accompanied difference in survival in all cases with a decline of about~     70 mois. However, these studies have focused solely on the patients included in the study~     receiving optimized treatment is not the standard treatment at the time. It is clearly~     demonstrated that the inclusion in a study brings a benefit to the patient. However, the~     majority of AJA are not included in a study. The investigators therefore want to describe~     the AYA population of CML in France and compare the evolution of patients included or not in~     a protocol. The investigators also want to investigate specific issues of the age of these~     patients as the reproductive desire. Indeed, while it does not seem to be any risk of~     teratogenicity for men treated with ITK, this risk is clearly established for women and~     requires specific supported. Another important point is that of the quality of life. The~     state of physical and mental health and his feelings, physical activity and its limitations~     and well-being was assessed by the SF-3612 questionnaire. The results of this analysis were~     compared with those already obtained for the general population (not representative of~     Italian adults with cancer sample) and adjusted for sex, age, geographic region, marital~     status and education level . There seems to be young people and women who express a feeling~     more pejorative. This does not only covers the frequency of side effects but also on~     physical activity and well-being. the affected population will be noted that that is~     particularly involved in the social, professional and in the development of his personal~     life. The impact of treatment on quality of life must be considered under penalty of seeing~     the difficulties of compliance. But several studies have demonstrated the negative impact of~     poor adherence in response to treatments .~   "
11756|NCT02903264|"~     This study evaluated the periodontal condition of gestational diabetes mellitus (GDM)~     patients and a healthy non-pregnant control group. For the GDM group all medical data were~     recorded, including obesity/insulin resistance indicators.~   "
11757|NCT02903251|"~     This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence~     in adults admitted for detoxification of alcohol, and during the following 4 weeks in an~     outpatient setting. Half of the participants will receive oxytocin nasal spray, the other~     half placebo nasal spray.~   "
11758|NCT02903238|"~     This is a two week,single-blind study evaluating pain response and changes in brain imaging~     upon treatment with placebo in people with knee OA.~   "
11759|NCT02903225|"~     Controlled exercise training is a valuable therapeutic addition to pharmacological treatment~     in most patients with chronic heart failure, reducing long-term mortality, preventing~     cardiac remodeling and improving functional capacity. Despite the mechanism underlying its~     benefits might be multifactorial, a sustained improvement in autonomic balance is usually~     attributed as a major effect. Nevertheless, not all eligible subjects show the same response~     to exercise, probably due to several differences in the subpopulations enrolled. The~     investigators hypothesize that some Heart Rate Variability indexes could be valid tools to~     optimize the selection and follow-up of chronic heart failure patients to training~   "
11760|NCT02903212|"~     The aim of the study is to determine the tolerance of apoptotic autologous cells injection~     in subjects with active rheumatoid arthritis.~   "
11761|NCT02903199|"~     The current study will investigate the effect if whey protein on postprandial glycaemia and~     appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite~     control (leptin, PYY3-36) hormone responses.~   "
11763|NCT02903173|"~     The purpose of this study is to evaluate the breathing patterns of women who undergo~     cesarean delivery with spinal or epidural morphine for post-operative pain control in the~     first day after surgery. Some women who undergo cesarean delivery may be at risk for~     respiratory complications related to opiate administration for post-operative pain. The~     primary aim of this study is to evaluate post-operative minute ventilation in women who~     undergo cesarean delivery using a novel method of non-invasive minute ventilation~     monitoring, and to see if there are predictive risk factors that may predispose women to~     post-operative hypoventilation.~   "
11764|NCT02903160|"~     The purpose of this study is to determine the clinical benefits of using a rapidly cycling,~     non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the~     management of castration resistant prostate cancer. The hypothesis is that the~     identification of optimal combinations and sequencing of therapies can help prevent or delay~     the development of therapeutic drug resistance, and can be safely tolerated.~   "
11765|NCT02903147|"~     The objective of the study is to examine the effectiveness of a functional-meta-cognitive~     intervention program to reduce driving risk factors amongst professional bus drivers.~   "
11766|NCT02903134|"~     This study seeks a better understanding of the pathogenesis of asthma in early life. The aim~     of this project is to determine whether the offspring of obese mothers at 3 years of life~     have increased the risk of asthma compared to children whose mothers were not obese and~     whether this increased risk is associated with a programming altered immune reactivity at~     birth.~   "
11767|NCT02903121|"~     The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective~     method of preventing pregnancy, but it has bleeding side effects that make it unappealing~     for many women. The only study to demonstrate a sustained reduction in bleeding lasting for~     two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the~     levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging~     preliminary data of tamoxifen and ENG implant users, the investigators plan to perform~     additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG~     implant users.~   "
11768|NCT02903108|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of~     boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP)~     patients.~   "
11769|NCT02903095|"~     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-1439 in healthy subjects~   "
11770|NCT02903082|"~     Sepsis remains a major cause of death in developed countries. A better understanding of the~     mechanisms involved in the regulation of inflammatory and immune response of patients with~     severe sepsis is an important step that could open the way for new therapeutic approaches.~   "
11771|NCT02903069|"~     This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine~     whether an investigational drug known as marizomib (MRZ) will improve the treatment of newly~     diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of~     the tumor, and/or improving survival.~   "
11772|NCT02903056|"~     Introduction: Rett Syndrome is a neurodevelopmental disease that primarily affects girls.~     Clinically, patients are normal before six months to one and half years old, and then~     develop progressive severe problems with communication, learning, co-ordination and~     neurodevelopment, with loss of motor skills around the age of two. At the same time,~     stereotyped hand movement typically appears. However, some of them will improve the~     abilities in speech and eye gaze, and the repetitive hand movements may decrease after few~     years.~      Background / hypothesis：Preliminary evidence suggests that there are many differences in~     brain structure between Rett syndrome and normal people including cerebral volume reduction~     in both white matter and gray matter, cerebral blood flow in the frontal area, and density~     of receptors in basal ganglia. In MR imaging studies, decreases in parietal lobe gray matter~     were found, and several reductions in cortical white matter were observed by DTI. However,~     the visual related pathway- posterior corona radiata in Rett syndrome girls was normal to be~     increased in FA values. The similar result was also discovered in the superior longitudinal~     fasciculus, associated with speech, which equal to control subjects and patients with~     preserved speech (phrases and sentences).Despite this, few studies mentioned comparison with~     brain microstructure in the different stage, especially in adult patients. Therefore, our~     prospective study will be planned to figure out the specific changing pattern of brain~     structure in different stages of Rett syndrome. And the trajectory of microstructure in~     brain is going to be in accordance with the functional improvement.~      The investigators suppose that (1)there are different microstructural changes for patients~     with/without preserved mobility, verbal ability and communication skill; (2)there are a few~     specific brain microstructures changes in visual pathway; (3) there is a specific changing~     pattern of brain microstructure in different aging of Rett syndrome. To acquire more~     specific results, the investigators aim to apply conventional MRI, diffusion-spectrum~     imaging, and some clinical assessment tools like Rett syndrome -related questionnaire, SSI,~     PDMS-2 and six-minute walk test to investigate their correlation.~   "
11773|NCT02903043|"~     Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most~     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to~     poor functional status and premature mortality.~      One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to~     change the regulation of angiogenesis in vastus lateralis of patients with COPD when~     compared to controls.~   "
11774|NCT02903030|"~     The physical and mental/emotional health of people with autism spectrum disorder (ASD) are~     closely connected. The emerging data on immune abnormalities and gut microbiome differences,~     and interactions of the genome with these suggest a possible etiological link between~     physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe~     anxiety that many individuals with ASD manifest. The investigators have preliminary clinical~     evidence that children with ASD & GI symptoms differ in microbiome composition and function~     from neurotypical children with GI symptoms. The investigators hypothesize that altered~     host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid~     (GABA) levels contribute towards anxiety and sensory over-responsivity in ASD. Our~     preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain~     symptoms, correlating with altered gut microbiome composition and related metabolites (the~     macrobiome). The proposed crossover trial will explore the possibilities of this new~     appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction,~     and anxiety. If altering the gut microbiome results in better GI and emotional function, it~     could improve the quality of life for children with ASD and their parents. A pilot trial~     with 12 children with ASD will test feasibility for a proposed three-site crossover~     randomized clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli &~     Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a~     balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per~     condition with 3 weeks washout between. The investigators have access to significant fecal~     microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on~     similar-age healthy and irritable-bowel children, with and without ASD. These will help~     leverage our understanding of macrobiome changes that correlate with functional improvement~     of GI and abdominal pain symptoms. Pilot study efficiency will also benefit from those HMPs~     having already collected and analyzed baseline stools for some children with ASD, thus~     saving significant costs for baseline stool analyses for the pilot.~   "
11880|NCT02901652|"~     Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure~     Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical~     ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within~     the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at~     26-30 weeks of gestation.~   "
11776|NCT02903004|"~     This is an open-label, prospective, multicenter, randomized Phase III, clinical trial~     evaluating the efficacy and safety of trabectedin in BRCA1 and BRCA2 mutation carrier and~     BRCAness phenotype advanced ovarian cancer patients in comparison to physician' choice~     chemotherapy.~      Arm A: Trabectedin 1.3 mg/mq d1 q 21 in 3 hours (central line) Arm B: Pegylated Liposomal~     Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd~     1, 8, 15 q 28 Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28~      Patients will be randomly assigned in a 1:1 ratio to treatment arms. During the~     randomization process, patients will be stratified by~        -  Platinum sensitivity~        -  Measurable disease~        -  Number of previous chemotherapy lines > vs < 3~        -  BRCA mutational status~   "
11777|NCT02902991|"~     Through this prospective clinical trial,the investigators will focus on the relationship~     between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA~     and other biomarkers) and the status of primary tumor to discuss its application for~     assessing prognosis and individualized therapeutic direction. Moreover, the relationship~     between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition~     and molecular pathological classification of breast cancer will be determined, which may~     enable the determination of the value of its application in therapeutic decision making.~   "
11778|NCT02902978|"~     The primary purpose of this study is to evaluate the safety, tolerability, and~     pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.~   "
11779|NCT02902965|"~     This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in~     combination with bortezomib and dexamethasone for patients with relapsed or relapsed and~     refractory multiple myeloma.~   "
11780|NCT02902952|"~     Anxiety is one of the most frequent comorbidities in children with ASD leading to poor~     clinical outcomes. Physical exercise has been shown to be a promising and easy to implement~     intervention for reducing anxiety. However, little is known about the feasibility and~     efficacy of physical exercise to reduce anxiety in children with ASD from underserved,~     low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino~     families will be recruited for the study and assigned to an exercise intervention group and~     a sedentary control group. The physical exercise program is an eight-week program,~     administered three times per week in small groups. Compliance, parent-rated anxiety, and~     salivary cortisol will be measured before and after completion of the exercise and control~     group interventions.~   "
11781|NCT02902939|"~     Pro- and anti-inflammatory response during the formation of the critical state develops at~     the same time. Because of its balanced or unbalanced systemic inflammation can be either~     aborted or able to lead to multiple organ failure. With regard to sepsis, systemic~     inflammatory response characteristics are well understood, is not achieved in respect of the~     sterile inflammation.~      Extracorporeal circulation is a clinical model of systemic inflammatory response due to~     non-physiological activation of tissue factor in the extracorporeal perfusion, the use of~     non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial~     translocation from the gastrointestinal tract and perfusion deficit.~      We have proved that the monocytes demonstrate suppressor function, which can be a predictor~     of complications from cardiac surgery patients.~      The most important component of the formation of multiple organ failure (MOF) in critically~     ill patients is immunosuppression.~      During the study of experimental and clinical tumor growth process scientists has provided a~     new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of~     myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the~     development of tumors, where it has been clearly shown that this cell population has an~     undoubted effect of immune suppression. However, recent studies show that the role of MDSC~     is not limited to cancer process, but extends to chronic or acute inflammation.~      The aim of this study is to determine the role of MDSC in the development of immune~     suppression and complications after heart surgery carried out under cardiopulmonary bypass.~   "
11782|NCT02902926|"~     IBS is a global disease, patients often because of long-term symptoms of recurrent, not~     timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect~     the quality of life, and cause the corresponding economic and social burden.At present，a~     number of studies suggest that fermentable oligosaccharides, disaccharides and~     monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized~     controlled trials are limited, leaving clinicians with the challenge of providing patients~     with reliable guidance based on minimal evidence.~   "
11783|NCT02902913|"~     Data from limited dietary intervention trials suggest that the cardiovascular health benefit~     of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs~     contain an array of bioactive compounds, little information exists regarding the~     physiological effects of specific chemical species. Among the EVOO-derived phenolics with~     demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an~     inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40~     mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were~     randomly assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were~     characterized and chosen for equivalency in their total phenolic content and fatty acid~     profiles, but differing in their oleocanthal to oleacein ratio.~   "
11784|NCT02902900|"~     This study, a national, multicenter, observational, ambispective, non-interventional study,~     will be conducted in French hospitals prescribing pomalidomide and already participating in~     the ongoing Imnovid registry.~      This study will add to the registry. Indeed, pomalidomide-prescribing physicians and~     pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who~     have been prescribed this drug since the date on which it was marketed regardless of the~     initiation date of pomalidomide or the indication for which it was prescribed.~   "
11785|NCT02902887|"~     This study presents an opportunity to understand a novel, previously unreported controlled~     intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of~     Intermittent exotropia (IXT).~   "
11786|NCT02902874|"~     To study the correlation between the polymorphism of the main immunity genes and~     progression-free survival in ALCL of the child.~   "
12933|NCT02887963|"~     The purpose of this study is to know the prevalence of iron deficiency (ID) and iron~     deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to~     analyze the epidemiological characteristics of ID/IDA and influencing factors.~   "
11787|NCT02902861|"~     This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in~     France, the Netherlands and the United Kingdom (UK) 1 center in each country respectively),~     randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate~     the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to~     Placebo as assessed by the primary endpoint 75% reduction of Psoriasis Area Severity Index~     (PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy~     of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious)~     Adverse Events ((S)AE) occurrence and questionnaires)~   "
11788|NCT02902848|"~     The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation~     state (prothrombin time) measured inside the therapeutical zone and thanks to a portable~     monitor. The values obtained at the point of care will be compared to the standard~     biological assessment.~   "
11789|NCT02902835|"~     The goal of this study is to test whether peer mentors (i.e., individuals with past opioid~     addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone)~     treatment for individuals with opioid use disorder who were recently released from jail or~     prison. In order to test whether it is helpful to have peer mentors paired with recently~     released individuals, the investigators will conduct an 18 month study, recruiting 72~     formerly incarcerated individuals and assigning them by chance selection (like flipping a~     coin) to either a group that will receive peer mentorship or a group that will receive a~     referral to a community clinic.~   "
11790|NCT02902822|"~     The purpose of this study is to demonstrate the validity and utility of a tele-dermatology~     system in the midterm periodic screening of non-widespread skin lesions of recent onset or~     for which a specialized early classification is deemed to change the prognosis - including~     precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to~     control visits at fixed follow-up.~   "
11791|NCT02902809|"~     A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese~     Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus~     Long-Acting β2-Agonist~   "
11792|NCT02902796|"~     A randomized controlled with cross over study compares efficacy of burst stimulation, 1000~     hertz stimulation, and standard stimulation in an non-superiority trial. The study duration~     is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks~     with approximately 4 days of wash off in between.~   "
11793|NCT02902783|"~     The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that~     observes the ICU management of consented deceased organ donors at 4 high volume centres over~     a period of 12 months each. The pilot study will be followed by a 1-year prospective~     national observational study a 15-20 ICUs across Canada.~   "
11794|NCT02902770|"~     The literature regarding analgesic modalities, their combinations and routes of~     administrations for patients with pain related to renal colic is expanding. NSAID's (IV~     ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic~     either alone or in combinations. Despite their synergism and analgesic superiority when~     administered together, both classes of these medications possess a set of unfavorable side~     effects that limit their use. Emerging data of the use of IV lidocaine for patients with~     renal colic demonstrated good analgesic efficacy and safety profile. However, none of the~     trials directly compared lidocaine to ketorolac or the combination of both as viable options~     in patients unable to tolerate or to have serious contraindications to opioids. We designed~     a double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and~     feasibility of non-opioid analgesics and their combinations in patients with renal colic.~     The hypothesis and proposed study will try to determine if a combination of IV lidocaine and~     reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid~     analgesic modality is effective for controlling pain of renal colic origin.~   "
11795|NCT02902757|"~     This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron~     emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response~     in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a~     patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the~     tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the~     start of therapy may help identify very early therapy response in patients with~     glioblastoma.~   "
11796|NCT02902744|"~     Primary Objective:~      • To collect post-approval safety data related to intraocular pressure (IOP) after one or~     more injections of Iluvien as standard of care in subjects with diabetic macular edema~     (DME).~      Secondary Objectives:~      • To collect visual and anatomic outcome data after one or more injections of Iluvien as~     standard of care in subjects with diabetic macular edema (DME).~   "
11797|NCT02902731|"~     SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50~     years. Despite recent progress and physiopathogenic, corticosteroids remains the standard~     treatment for decades with a very good initial clinical efficacy but a high relapse rate~     (nearly 40% to 6,5 months) during its decay. This sensible population is particularly~     exposed to the side effects of corticosteroids, leading to think about savings strategies.~     But the association of immunosuppressive therapy and/or anti- TNFα has not demonstrated~     benefits in terms of efficiency or long-term tolerance to cumulative doses of prednisone.~     The responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been~     studied in the pathogenesis of GCA in temporal artery walls and in mouse models. The primary~     pathogenic role of IL- 1 is based on the increase in serum or nuclear protein itself or that~     of its mRNA. The study of temporal artery biopsies has shown increased local production of~     IL- 1β mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL~     2 (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the~     efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β,~     in three cases GCA refractory to conventional treatments.~      Here investigators propose a randomized, multicenter, controlled, double-blind study of~     anakinra against placebo in addition to corticosteroids in the treatment of GCA.~      This study will include 70 patients randomized equally in both arms: reference treatment~     (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment~     with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on~     day 1, followed by a progressive decrease in the dose pattern depending on the weight. In~     the experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by~     subcutaneous injection from day 1 until the end of week 16 (S16). In the reference arm of~     the treatment, a placebo anakinra is associated with corticosteroid in the same packaging,~     duration and respecting the double-blind.~      Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to~     placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed,~     the challenge of corticosteroid therapy in this disease is not so much a problem of initial~     effectiveness, than the adverse events related to relapses and steroid dependence.~   "
11798|NCT02902718|"~     The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home~     facial skin rejuvenation.~   "
11799|NCT02902705|"~     Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and~     dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the~     underlying mechanisms of these disturbances remain elusive. Many in vitro studies have~     demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic~     environment. In good agreement, several animal experiments have reported that chronic kidney~     disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid~     redistribution. The goal of this protocol is to collect and study structural and metabolic~     properties of white adipose tissue in CKD stage V patients to evidence adipose tissue~     dysfunction associated with CKD. The primary outcome measure will be the cellularity of the~     adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene~     expression profile using microarray and metabolic properties of adipose tissue (i.e.~     lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD~     stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the~     Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The~     biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during~     elective urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical~     prostatectomy for non CKD patients).~   "
11800|NCT02902692|"~     The current study will examine the effects of a brief mindfulness based intervention (BMBI)~     on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants~     for the study will be 90 adults aged 50 years and above who have presented at a memory~     clinic within SLaM NHS Trust with subjective cognitive concerns and/or those who have~     received a diagnosis of mild cognitive impairment (MCI) from their memory clinic.~   "
11801|NCT02902679|"~     An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants~     before and after a hemodialysis session to evaluate safety, tolerability, and~     pharmacokinetics in this patient population.~   "
11802|NCT02902666|"~     The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000~     mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms~     of rate and extent of absorption, when administered as single oral dose (one tablet of the~     new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to~     healthy male and female volunteers, under fasting conditions, in two consecutive study~     periods.~   "
11803|NCT02902653|"~     This study evaluates the efficacy and safety of the administration of oral misoprostol~     versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor~     induction.~   "
11804|NCT02902640|"~     This is a pilot, observational and multicentric study of safety of sulfamethoxazole plus (+)~     trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis.~     Overall, 50 adult participants with acute bronchitis eligible for treatment with~     sulfamethoxazole + trimethoprim + guaifenesin will be enrolled. Administration of Balsamic~     Bactrim will be according to physician's recommendation under local labeling.~   "
11805|NCT02902627|"~     l'ANI (Analgesia Nociception Index~      The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a~     parameter giving the possibility of measuring the pain in painful metastatic cancer. The~     parameter ANI is compared with visual analogical scale (VAS) score.~   "
11806|NCT02902614|"~     Selection of side of embryo biopsy that will not interfering with implantation power of~     developed blastocyst embryo during biopsy procedure arranged for PGT.~   "
11807|NCT02902601|"~     The primary purpose of this study is to investigate the safety and tolerability of JNJ~     54175446 in participants with Major Depressive Disorder (MDD).~   "
11808|NCT02902588|"~     The purpose of the study is to confirm the applicability and usefulness of the novel method~     of assessment of the permeability of the blood-brain barrier and in monitoring of the~     treatment of patients with meningitis. The proposed technique is based on evaluation of the~     kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared~     spectroscopy (NIRS). Usefulness of the NIRS-based method will be analyzed in relation to the~     reference method, which is contrast-enhanced magnetic resonance imaging (MRI).~   "
11809|NCT02902575|"~     The purpose of this study is to explore the safety, feasibility, long-term and~     oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after~     neoadjuvant chemotherapy.~   "
11810|NCT02902562|"~     This study is about using contrast-enhanced ultrasound (CEUS) to assess the degree of~     synovitis (joint inflammation) in patients with inflammatory arthritis, such as rheumatoid~     arthritis, and whether it can be used for assessing a treatment response. The investigators~     hope to learn whether contrast enhanced ultrasounds are better than regular imaging~     techniques, such as MRI, when used to evaluate the response to disease modifying~     anti-rheumatic drug (DMARD) therapy in inflammatory arthritis.~   "
11811|NCT02902549|"~     Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation~     in real-time during surgery. Complications due to vascular compromise are a major problem,~     especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue~     necrosis. If, however, perfusion and ischemia could be monitored during surgery, then~     surgeons could change their reconstructive design and the anaesthesiologists could improve~     perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a~     tool that is able to image in high resolution (microvascularisation), direct,~     intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying~     vessels) and that produces quantitative data to objectify image interpretation.~      Optical techniques, based on the interaction of light with tissue, are able to image tissue~     at high resolution and in real-time. These techniques are FDA-approved and have emerged as~     powerful diagnostic tools in different departments of medicine, such as ophthalmology for~     visualizing retina vascularisation and dermatology for skin diagnostics.~      In this study, investigators hypothesize that four novel optical technologies: Fluorescence~     Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream~     Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.~   "
11812|NCT02902536|"~     This is a study during which the investigators collect plasma and cells from patients with~     myasthenia gravis for the purpose of finding new antibodies.~   "
11813|NCT02902523|"~     A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and~     pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir~     Disoproxil Fumarate) in healthy male volunteers~   "
11815|NCT02902497|"~     The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the~     cochleostomy location of an endaural approach (MINV) compared to the conventional posterior~     tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice~     a new surgical endaural approach to perform cochlear implantation. In the hands of an~     inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail~     for this technique. This is a prospective study of 24 human heads. Straight electrode arrays~     were implanted by an inexperienced surgeon: on one side using MPT and on the other side~     using MINV.~   "
11816|NCT02902484|"~     The study will perform a clinical study evaluating the safety and tolerability of nintedanib~     when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic~     pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast~     enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and~     microvessel density.~   "
11817|NCT02902471|"~     A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans~     syndrome in patients after bone marrow transplantation. The force oscillations technique~     will be compared with classical spirometry.~   "
11818|NCT02902458|"~     This study aims to investigate whether follow-up with a psychologist has an impact on the~     outcome of patients with an implantable automated defibrillator.~   "
11819|NCT02902445|"~     The GASTROVIM research explores the links between individual genetic susceptibility, genetic~     variability of rotavirus strains and effectiveness of immunization with the rotavirus~     vaccination: a clinical investigation to assess glycan attachment specificity, toward~     rotavirus vaccine improvement.~   "
11820|NCT02902432|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human~     endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced~     squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent~     radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of~     induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin~     and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for~     a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous~     pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1,~     d3-d7, d10-d14, d17-d21) during IMRT.~   "
11821|NCT02902419|"~     A randomized controlled trial measuring surgical site infection rate as a function of timing~     of wound dressing removal.~   "
11822|NCT02902406|"~     This is a follow up study which aims to evaluate the correlation between several methylated~     genes (potential biomarkers) and oral cancers. A prospective case control trial is designed~     with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion~     or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the~     National Taiwan University Hospital Research Ethics Committee. After signing the informed~     consent, all subjects will receive an intraoral examination and followed by epithelial cells~     collection with oral swab. The gDNA will be extracted from the oral swab collected cells and~     followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be~     subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical~     sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis~     confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.~   "
11823|NCT02902393|"~     Revascularisation using recombinant tPA is the reference treatment of stroke. However, the~     efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have~     been associated with revascularisation efficacy.~      The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with~     stroke with thromboelastography and to correlate results with the clinical outcome of~     patients. Results may predict revascularisation in patients with stroke.~   "
11824|NCT02902380|"~     Surgical stress induces stress hormone release and sympathetic hyperactivation.~     Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study~     investigate the effect of dexmedetomidine on stress responses and autonomic nervous system~     balance in patients undergoing major spine surgery.~   "
11825|NCT02902367|"~     Eighty community-living individuals in Uppsala municipality will be included. Intervention:~     Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments,~     questionnaires and medical records. Assessment of motor function, cognition, level of~     physical activity, food intake and perceived stress are performed at screening as baseline~     measurements. Walking capacity, mobility, handgrip strength, body composition and~     cardiovascular risk markers will be assessed at baseline and after 12 week of training. At~     one year after training health-related quality of life, another cardiovascular incidence and~     mortality will be documented.~   "
11826|NCT02902354|"~     To determine the central blood pressure changes in normotensive women who are receiving~     nifedipine for uterine contraction suppression~   "
11827|NCT02902341|"~     Background: Malnutrition is widespread among cardiac surgery patients and is independently~     related to an adverse postoperative evolution or outcome. The investigators aimed to assess~     whether nutrition therapy (NT) could alter caloric deficit, morbidity, and mortality in~     patients scheduled for non-emergency coronary artery bypass graft (CABG) or aortic valve~     surgery.~      Methods: 351 patients undergoing either elective CABG or aortic valve surgery were studied.~     Patients receiving NT were enrolled from January 2013 until December 2014. A historical~     control group consisted of 142 matched patients. Preoperative nutritional status was~     evaluated. Resting energy expenditure was measured using indirect calorimetry or calculated.~     Caloric intake and caloric deficits were assessed. The primary endpoint was to evaluate~     whether NT could limit caloric deficit (Intake to Need Deviation). A secondary endpoint~     addressed the potential effect of NT on morbidity and mortality. Patients were followed for~     one year after surgery.~   "
11828|NCT02902328|"~     SIS has developed a software technology, based on machine learning and image processing,~     designed to enhance standard clinical images for the visualization of anatomical structures.~   "
12365|NCT02895477|"~     Goal of this study is to determine the benefit of an improved feature on a new hearing aid~     platform.~      To investigate the improvements of this feature is compared on a new and older hearing aid~     platform. The obtained results will be used for future improvement for this feature. This~     feature should improve the speech understanding and speech recognition of the hearing aid~     user.~   "
11829|NCT02902315|"~     Acutely resistance exercise induces inflammatory responses and leukocytosis arising of~     oxidative stress, that clinically manifested by pain and/or delayed onset muscle soreness~     (DOMS). Beginners in resistance exercise programs are more vulnerable to the effects of~     oxidative stress as they exhibit lower antioxidant capacity, greater lipid peroxidation and~     present increased perception of pain after exercises that may lead to abandonment the~     exercises practice. Vitamins C and E are exogenous antioxidants which are able to prevent~     damages caused by oxidative stress. Cryotherapy decreases temperature and reduced generation~     of reactive oxygen species. The aim of the present research are to investigate the effects~     of the concomitant of vitamins and of cryotherapy on leukocytosis, inflammatory markers,~     oxidative stress parameters and pain in untrained individuals submitted to a resistance~     exercise session.~   "
11830|NCT02902302|"~     The main objective of the study is to evaluate the bioequivalence of a new formulation of~     ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg~     film-coated tablet, when administered under fasting conditions as single oral dose to~     healthy male and female volunteers, in two consecutive study periods.~   "
11831|NCT02902289|"~     The main objective of the study is to evaluate the bioequivalence of a new formulation of~     ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg~     coated tablet, when administered under fasting conditions as single oral dose to healthy~     male and female volunteers, in two consecutive study periods.~   "
11832|NCT02902276|"~     In critically ill patients, the small bowel permeability is increased, leading to bacterial~     translocation, and systemic inflammatory response syndrome.~      Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide~     (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of~     bacterial translocation. The link between plasma citrulline and LPS in the critically ill is~     unknown. Investigators hypothesize that patients presenting with low plasma citrulline~     concentration, with presumed altered small bowel function, would have an increased~     phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators~     aimed to evaluate the link between plasma citrulline and LPS concentrations in critically~     ill patients at the time of ICU admission.~   "
11833|NCT02902263|"~     Early thrombolysis is essential in treating ischemic strokes. The time window for~     thrombolysis is limited to 4,5 hours after symptoms onset.~      In the French region of Franche Comté, in order to reduce the thrombolytic delay, a~     telemedicine network was developed between the neurovascular reference unit (NVU) localised~     in the University Hospital of Besançon and the peripheral hospital centres. Patients may~     then be transported to the NVU immediately after the thrombolysis initiation.~      The aim of our study was to assess the relevance of a systematic medicalization of transfer~     to the NVU of patients with stroke who were telethrombolyzed before.~      It was a retrospective, monocentric and observational study conducted over 24 months, in~     Franche-Comte (France).~   "
11834|NCT02902250|"~     The purpose of this study is to compare the treatment efficacy between vertebral body~     decompression procedure and vertebroplasty with non-inferiority design~   "
11835|NCT02902237|"~     In this phase I clinical trial cancer patients suffering from solid tumors or lymphomas,~     recurring after and/or refractory against standard treatment are treated intravenously (iv)~     with increasing doses of tTF-NGR(tTF= truncated tissue factor; NGR=Asn-Gly-Arg). The~     objectives of this trial are to evaluate the maximum tolerated dose (MTD) and the~     dose-limiting toxicity (DLT) of intravenously (iv) infused daily applications of tTF-NGR for~     5 days every 3 weeks in patients with cancer, who had obtained all standard treatment known~     for their disease entity prior to entry on study. Further objectives are to determine the~     perfusion and vascular volume fraction of measurable tumor lesions versus normal reference~     tissue before and after tTF-NGR application by MRI as a biological surrogate parameter for~     biological activity of the investigational medicinal product (IMP), tTF-NGR, and to obtain~     pharmacokinetic data.~   "
11836|NCT02902224|"~     The objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI before and after bariatric surgery. Administration of~     glucose as well as fructose is followed by functional brain MRI, and findings are correlated~     with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese~     humans.~   "
11837|NCT02902211|"~     This study will determine whether an ankle foot orthosis (AFO) improves walking performance~     in patients with PAD from its first use. Additionally, the study will test walking~     performance after a three month AFO intervention and will examine the feasibility of this~     AFO intervention.~      Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched~     controls will be participate in one baseline gait assessment for comparison purposes. Both~     groups between 40-85 years old.~      Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a~     biomechanics evaluation at baseline, following three months of control (standard of care),~     and following three months of AFO intervention. The evaluation will include measurement of~     walking distances, gait function, physical activity, quality of life, energy cost, muscle~     morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while~     walking with and without the AFO. Healthy controls will be assessed during one baseline~     collection only and their participation in the study will then be finished.~      Feasibility interview: All patients with PAD will participate in feasibility interviews that~     will assess acceptability, demand, implementation, and practicality. Interviews will occur~     1.5 months and following completion of the AFO intervention (not the control arm).~      AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon~     composite AFO that is adjusted for them for three months. The patients will be asked to wear~     the AFO at all times except when they are in bed or showering/bathing. The instructions~     given to the patients about walking will be to follow the instructions from their doctor~     regarding risk factor management and exercise. The intervention order will be randomized and~     all subjects will participate in both arms.~   "
11838|NCT02902198|"~     The objective is to investigate neuro-anatomical correlates of gastrointestinal taste~     stimulation by means of functional MRI before and after bariatric surgery. Intragastric~     administration of glucose, monosodium glutamate, chloroquine and placebo is followed by~     functional brain MRI in obese humans before and 3 months after surgery.~   "
11851|NCT02902029|"~     Most patients with locally advanced or metastatic tumors succumb to their disease. Thus,~     there is a substantial need for novel therapeutic strategies to improve the outcome for~     patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway~     by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an~     antiPD-L1 antibody have emerged as treatment option.~      In this study the best timing for sequential use of both treatment options (BRAF/MEK~     inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600~     mutant melanoma will be assessed.~   "
12366|NCT02895464|"~     The purpose of the study is to evaluate the feasibility of recruitment procedure,~     intervention including compliance and the collaboration between in- and out patient clinics~     of preoperative home-based exercise in older people before colorectal surgery.~   "
11839|NCT02902185|"~     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)~     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected~     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.~     HIV persistence is thought to stem primarily from the presence of integrated copies of the~     proviral genome within long-lived cells. Because active viral gene expression causes cell~     death due to viral cytopathic effects and the immune response, long-lived cells likely~     harbor transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular~     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)~     these latently infected cells. This will make the HIV infected cells visible to the immune~     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate~     (Kill) the infected cells. This study is subsequent to our NCT02513901. The purpose of~     this study is to verify the efficacy of multi-dose Chidamide in combination with~     antiretroviral therapy in HIV-infected adults with suppressed viral load in a randomized~     controlled clinical trial.~   "
11840|NCT02902172|"~     Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and~     deliver an infant via vaginal delivery will be placed into two groups in the postpartum~     period. One group will receive Ibuprofen for pain control and the other group will be given~     Tylenol. Blood pressures during the postpartum period will then be collected and compared in~     order to see if NSAIDs use increases blood pressure.~   "
11841|NCT02902159|"~     A randomised controlled trial to compare the effect on wellbeing of an online peer review~     website (Big White Wall) compared to freely available online information (NHS Moodzone) for~     people with depression and anxiety.~   "
11842|NCT02902146|"~     This prospective, open-label trial randomizes adult patients intubated in the ED with a~     Macintosh blade to use or not use a bougie for the first intubation attempt. The primary~     outcome is first pass success.~   "
11843|NCT02902133|"~     This is a non-randomized pilot study of Acetazolamide administration in patients at high~     risk for CSF leak after endoscopic skull base surgery.~   "
11844|NCT02902120|"~     The purpose of this study is to determine whether patients treated for chronic hepatitis C~     (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger~     immune response compared to patients treated after kidney transplant. 25 patients with~     chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant~     recipients with chronic kidney disease will be treated with zepatier. Blood markers of~     immune function will be monitored in both groups to determine their response to therapy.~   "
11845|NCT02902107|"~     This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy~     (IORT) device that offers several advantages over existing techniques of performing IORT.~     The CivaSheet device in this study is already approved by the FDA and is not an experimental~     device. This study will allow us to determine how feasible it is to implant the CivaSheet~     into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible~     side effects of the device. This study, if successful, may allow us to offer the CivaSheet~     more widely as treatment option to future patients.~   "
11846|NCT02902094|"~     DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and~     effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty~     balloon in patients with symptomatic native AV fistula stenosis.~   "
11847|NCT02902081|"~     The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid~     compound found in marijuana, on responses to emotional stimuli. Both preclinical and~     clinical studies indicate that CBD may act to reduce anxiety without excessive sedative~     side-effects. Thus the investigators hypothesize that CBD may reduce responses specifically~     to negative emotional and social stimuli, including pictures and emotional faces, without~     altering responses to positive stimuli. To examine this, the investigators will administer~     placebo, 300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind~     within-subjects study. The investigators will measure subjective and subtle physical~     responses to positive and negative stimuli using measures that have been characterized with~     classic anxiety-reducing drugs and drugs of abuse. Further, the investigators will examine~     whether CBD-induced changes in these measures of emotional response relate to changes in~     actual behavior in a controlled social interaction. These results will allow the~     investigators to examine the potential usefulness of CBD as an anxiety-reducing drug, and~     suggest mechanisms by which CBD may reduce anxiety.~   "
11848|NCT02902068|"~     In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in~     women undergoing cesarean section delivery.~      This study is a purely observational study, it will not have any clinical intervention nor~     will it interfere with standard cesarean delivery protocols in any way. This study's primary~     objective is to evaluate how spinal and general anesthesia influences cardiac output during~     cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as~     measured in cardiac output correlate with women's pain, measured by a visual analogue~     scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)~   "
11849|NCT02902055|"~     Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe,~     life-threatening lung injury. Care for paediatric patient is mainly supportive and based on~     what works in adults and personal experiences, including the use of mechanical ventilation.~     However, differences in lung physiology and immunology between (young) children and adults~     suggests that adaptation of adult practices into paediatrics may not be justified. A study~     in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA)~     improved 90-day survival and increased time off the ventilator without increasing muscle~     weakness. It is unknown if this is also true for paediatric ARDS~   "
11850|NCT02902042|"~     This study will investigate the influence of maintenance therapy on progression-free~     survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK~     kinase) inhibitors and PD-1 antibody pembrolizumab.~      In the safety phase I part the optimal dose of pembrilizumab in combination with BRAF~     inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be~     determined.~      In the randomized part 2 different maintenance therapies will be tested for toxicity and~     efficacy. Patients with disease control after 6 months of triple therapy will be randomized~     to receive 2 different maintenance therapies further on, either continuation of triple~     therapy or administration of pembrolizumab alone.~   "
11856|NCT02901964|"~     Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one~     of the most common causes of joint pain. Characterized by their chronicity, slow and~     progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is~     estimated at 3.8%, with peak prevalence in the population with an average age of 50 years.~     The main objectives of interventions in patients with knee OA are reduced pain and improved~     functional capacity and exercises are widely recommended. The literature shows a lack of~     clinical trials verifying the effect of strengthening the hip muscles in patients with knee~     osteoarthritis. Thus, the aim of this study is to assess the effect of strengthening the hip~     abductor muscles versus hip adductor muscles in patients with symptomatic OA of the knee.~   "
11857|NCT02901951|"~     The purpose of this study is to assess the long-term protection against HBV infection in~     adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30~     years ago~   "
11858|NCT02901938|"~     This study will investigate the effects of implantation of cemented femoral stem versus~     percutanous internal fixation with cannulated compression screws on hip joint function~     recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis~     infection, and the histocompatibility of prosthesis material with host tissue in the elderly~     patients with osteoporotic fracture of proximal femoral neck complicated by avascular~     necrosis of the femoral head, which will provide scientific evidence for selecting surgical~     methods and internal fixation/artificial prosthesis material for osteoporotic fracture of~     proximal femoral neck in the elderly patients.~   "
11859|NCT02901925|"~     The primary study objective is to determine if microdoses of ABY-029 lead to detectable~     signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining.~      The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI~     and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g.~     proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake~     and concentration of ABY-029 in resected specimens.~   "
11860|NCT02901912|"~     Gut microbiota comparison of active and sedentary women~   "
11861|NCT02901899|"~     The purpose of this study is to look at how patients respond to treatment with guadecitabine~     and pembrolizumab. The researchers will also be looking at the amount of time it takes for~     cancer to get worse when participants take the study drugs. All participants will be treated~     with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA~     and can increase the production of certain proteins, making cancer cells more recognizable~     by the immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the~     combination of guadecitabine and pembrolizumab may increase the ability of the immune system~     to eliminate cancer cells. Researchers want to find out whether the combination of~     guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not~     responded to traditional chemotherapy. Participants will keep receiving treatment until~     their cancer gets worse, they have side effects, or they decide they don't want to receive~     the treatment anymore. After stopping treatment, the study doctor will watch participants~     for side effects and follow their condition every 6-12 weeks. The study aims to keep track~     of participants' medical conditions for the rest of their lives. This helps us look at the~     long-term effects of the study drugs.~   "
11862|NCT02901886|"~     This study aims to test the effect of an intensive smoking cessation intervention~     (motivational counseling combined with nicotine replacement) on smoking cessation and~     disease activity in patients with Rheumatoid Arthritis (RA). Half of the patients will~     participate in a smoking cessation intervention; the other half will receive usual~     treatment.~   "
11863|NCT02901873|"~     Parathyroid glands are involved in calcium metabolism and their damage during neck surgery~     results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels;~     this is associated with significant short and long term morbidity. There are four~     parathyroid glands in the neck which can vary in size and location. They can be mistaken for~     lymph nodes, fat or thyroid nodules. A normal parathyroid gland is the size of a small pea~     and is often difficult to recognize during surgery; making it susceptible to inadvertent~     injury or removal.~      Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate~     identification of parathyroid tissue during surgery reduces the likelihood of~     hypoparathyroidism. However, this complication is still common. Research exploring the use~     of intraoperative technologies to enable early identification and preservation of normal~     parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one~     such technology. ZedScanTM is a handheld device that measures electrical impedance of~     tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening.~     The device has a CE mark for this purpose and is safe to use in humans. We have already~     demonstrated that electrical impedance spectroscopy can detect differences in cellular~     structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate~     the feasibility of using this technology (ZedScanTM) in humans. This has potential to be~     used in thyroid and parathyroid surgery to differentiate parathyroid glands from other~     structures; thereby decreasing their damage and the risk of post surgical hypothyroidism.~   "
11864|NCT02901860|"~     The purpose of this research is to test the hypothesis that those with non-traditional work~     schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with~     traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the~     degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of~     this research are expected to increase our understanding of physiologic tolerance to~     non-traditional work schedules and provide the basis for the development of methods for the~     early detection of adverse health effects and determine coping strategies for the millions~     of workers with non-traditional work schedules.~   "
11865|NCT02901847|"~     The aim of the project is to investigate the clinical and patient centred outcomes of people~     with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway,~     utilising advice on diet, activity and smoking cessation. The podiatry clinic will be~     delivered from the Move More centre (NCSEM) and participants will be encouraged to access~     these facilities as part of their activity programme which will be agreed with the physical~     activity team. Primary and secondary outcomes will be clinical - claudication pain, distance~     walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced~     BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with~     the programme will also be assessed.~   "
11866|NCT02901834|"~     Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain~     characteristics, the impact of pain, and pain treatment outcomes are different in~     adolescents compared to children and adults. In response, we will develop and test the~     PainSquad+ pain management smartphone app. First, we will conduct usability testing to~     refine PainSquad+ so that it is useable, acceptable and understandable for AWC. Secondly we~     will: (a) test the feasibility of conducting a large-scale PainSquad+ experiment and (b)~     begin to examine how effective PainSquad+ is at helping adolescents manage pain. We hope~     that once developed and tested for effectiveness, PainSquad+ will improve pain treatment and~     ultimately quality of life in AWC.~   "
11867|NCT02901821|"~     The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid~     (miRNA) expression that are predictive of symptom duration and severity following mild~     traumatic brain injury (mTBI) in children.~   "
11868|NCT02901808|"~     The registry includes patients undergoing cardiovascular and thoracic surgery at the~     Saarland University Medical Center, Homburg/Saar, Germany. This study is a monocentric,~     retrospective study investigating the development of NOMI and outcome of patients.~   "
11869|NCT02901795|"~     All included patients will have their fetal heart rate recording performed with an EDAN F3~     fetal monitor that allowed the back up recording of the fetal heart rate beat to beat~     detection. Fetal heart rate variability analysis will be performed using Matalb® software.~   "
11870|NCT02901782|"~     Microwave ablation of bone tumors is time-consuming and usually results in postoperative~     fractures. Hence the investigators designed and fabricated a titanium plate customized to~     the patient's bone structures for fixation after the removal of tumorous tissue, to improve~     the clinical outcomes of microwave ablation.~   "
11871|NCT02901769|"~     Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But~     as it can occur in patients with no psychiatric illness and doesn't occur in every patients~     with psychiatric illness, it has to be considered henceforth as a specific vulnerability.~      This trial will study two fMRI paradigms, emotional prosody recognition and decision making,~     in order to characterize emotional and cognitive trait factors in a population of patients~     vulnerable to suicide. Four different groups will be constituted : depressed suicide~     attempters, depressed patients with past history of suicidal acts, depressed patients with~     no history of suicidal acts and healthy controls.~      The main goal will be to correlate fMRI activation during the two paradigms in subjects~     vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive~     trait factors in these subjects, to demonstrate that those characteristics are independent~     from depression and to correlate these trait factors with socio-demographic and clinical~     features with fMRI activations.~   "
11872|NCT02901756|"~     Adult patients suffering from migraine according to the criteria of the International~     Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous~     month; exclusion of chronic migraine and medication overuse) and after a one-month baseline~     phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg~     magnesium per day for 3 months.~   "
11873|NCT02901743|"~     The main aim and objective of this study was to evaluate the effects of Non- surgical~     periodontal therapy on the subgingival microbiota and biochemical parameters in patients~     with chronic kidney disease and chronic periodontitis.~   "
11874|NCT02901730|"~     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a~     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an~     existing angle close or angle adhesion in order to reduce the risk of attack of the angle~     closure glaucoma. However, there are very little research on the laser site, laser~     wavelengths, laser energy and laser spot intervals. The purpose of this study is to~     determine the optimum laser wavelengths of LPI.~   "
11875|NCT02901717|"~     This is a Phase 3, multi-center, randomized, double-blind study to determine the efficacy~     and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate~     disodium in 25% ethanol solution.~      Approximately 700 subjects who have been diagnosed with CRBSI/CLABSI and who meet all~     necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:~        -  MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or~        -  Control Arm (subjects randomized to the Control Arm will receive treatment based on the~          type and virulence of the infecting organism as documented by the Investigator prior to~          randomization)~   "
11876|NCT02901704|"~     The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal~     denervation in subjects with primary hypertension by using Iberis multielectrode renal~     denervation system~   "
11877|NCT02901691|"~     The deaf children showed deficits in speech processing and temporality. They badly apprehend~     temporal concepts and perceptions of deficit so the acoustic phenomena marking the time~     course linguistically. Their prediction capabilities and anticipation multisensory events~     are thereby affected, thus impacting their ability to adapt to multiple and complex~     interaction possibilities that arise during a conversation.The project aim it is to measure~     the impact of a musical rhythmic stimulation of neuronal activity and the temporal~     prediction capabilities of older deaf children 5 to 8 years and its impact on their language~     skills in a conversational task. A matched control group of age will be examined for each of~     the proposed tasks.~      We first measure the capacity to anticipate a situation of language interaction. For this~     purpose, we will use an alternate naming paradigm with a virtual partner, already developed~     and tested in children with normal hearing. This paradigm approaches the conversational~     situation while allowing control of the time parameter of speech (speed of trade) and by~     controlling the bias (temporal) inherent linguistic programming difficulties of children in~     a spontaneous conversation situations .~      Then we will couple behavioral measurements with measurements of eye movements and the~     electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task~     already developed for normal hearing children. This task will allow us firstly to analyze~     the anticipation level of speaking turns by analyzing eye movements (which precedes the~     speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic~     parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor~     system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of~     anticipatory processes and convergence in conversational interaction will also be studied~     using cortico-cortical coherence techniques to assess the dynamics of connectivity between~     remote networks (system here auditory and motor system).~   "
11878|NCT02901678|"~     A Randomized clinical trial comparing two different force magnitudes in maxillary posterior~     segment intrusion in adult patients with skeletal open bite malocclusion~   "
11879|NCT02901665|"~     The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes~     pre and post a planned unit-wide intervention aimed at increasing parent presence in the~     Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an~     expectation that all NICU parents be present at minimum 4 hours/day versus the current~     practice of telling families to come as much as they can that has resulted in inconsistent~     parent presence.~   "
11881|NCT02901639|"~     Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but~     are also a great social and financial burden on societies and countries. According to~     World-health-organization statistics, there are an estimated 200 million pregnancies around~     the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy~     also is a major health problem in the United States of America. In the 2002 National Survey~     of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When~     abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all~     pregnancies~   "
11882|NCT02901626|"~     The purpose of the study is to determine whether the Arabin pessary is a useful intervention~     of preterm birth at less than 37 weeks in women with a singleton gestation and a short~     cervix.~   "
11883|NCT02901613|"~     To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound~     complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical~     Center Hospital. Retrospective data will be collected regarding morbidly obese patients who~     have undergone cesarean section and patients will be recruited to have the intervention~     (negative-pressure wound therapy) applied and outcomes will be evaluated.~   "
11884|NCT02901600|"~     Although colorectal cancer is a preventable and curable disease if early stage tumors are~     removed, it is still the fourth cause of cancer worldwide and the second leading cause of~     death in many industrialized countries. The 5-year survival is about 55% often due to a late~     detection. Then, the identification of sensitive and specific molecular markers is therefore~     a major challenge for early diagnosis and prognosis of this disease.~      Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant~     brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during~     several stages of colon carcinogenesis. The goal of this study is to study by mass~     spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal~     tumors of various stages, grades, and recurrence status.~   "
11885|NCT02901587|"~     The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity~     in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or~     schizoaffective disorder after 6 weeks of treatment~   "
11886|NCT02901574|"~     People with post-stroke aphasia are left with some degree of chronic deficit for which~     current rehabilitative treatments are variably effective. This study investigates the~     behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with~     computerized naming therapy in stroke survivors with aphasia.~   "
11887|NCT02901561|"~     The purpose of the investigators' study was to evaluate whether misoprostol will improve~     pain scores .~   "
11888|NCT02901548|"~     The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736)~     given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the~     bladder that no longer responds to Bacillus Calmette-Guérin (BCG) and to collect information~     on the safety of these drugs and whether they cause any side effects.~   "
11889|NCT02901535|"~     The purpose of this study is to determine the effectiveness of telemedicine multifaceted~     intervention in symptoms patients with chronic obstructive pulmonary disease.~   "
11890|NCT02901522|"~     The purpose of this study is to determine the effectiveness of telemedicine multifaceted~     intervention in symptoms patients with asthma.~   "
11891|NCT02901509|"~     QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of~     infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK~     cohort by comparing scores of SF-36 health survey.~   "
11892|NCT02901496|"~     Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying~     mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute~     elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed~     gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral~     and epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus,~     the investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced~     reduction in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced~     adaptations in glucose metabolism and gastric motility are dependent on IL-6. Finally the~     investigators hypothesise that both endurance and resistance exercise training reduce VAT~     and EAT.~      Primary aim: To investigate the effects of exercise training on VAT and to determine to what~     extend IL-6 mediates this effect.~      Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can~     reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism~     and gastric emptying are dependent on IL-6.~      Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or~     waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week,~     double-blinded randomised, placebo-controlled exercise intervention study.~      Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6~     receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance~     training, iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v)~     Placebo to Tocilizumab, and resistance training. Tocilizumab/placebo dose will be~     administered (according to standard recommendations) before the first training session, and~     maintained during the 12-week training program. Training will be supervised to ensure~     intensity and compliance. Subjects will be instructed not to change eating habits and~     informed that this study does not aim for a weight loss.~      Statistical considerations: Study investigators are blinded to treatment allocation.~     Dropouts will be replaced. A sample size of 70 subjects is needed to detect a 10% change in~     visceral adipose, with a power of 80% and a significance level of 0.05.~   "
11893|NCT02901483|"~     It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck~     squamous cell carcinoma (HNSCC) patients.~        -  Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in~          this phase to identify the recommended intratumor injection volumes of PEP503.~        -  Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18~          additional patients will be enrolled at the recommended volume level to evaluate for~          safety and efficacy.~   "
11894|NCT02901470|"~     The support of help to the prevention of sores include a big diversity of devices. The~     clinical experiment of these support comes up against the problem of the large number of~     factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to~     estimate the incidence of bedsores in these supports, with control of other factors~   "
11918|NCT02901158|"~     Esophageal pressure measurements are used in to determine chest wall elastance and calculate~     lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated~     esophageal balloon catheter is then placed in the esophagus to measure tidal variations in~     esophageal pressure.~      In this study high resolution solid-state manometry technique was used to provide detailed~     and continuous measurements of esophageal pressures in the different parts of the esophagus.~     Measurements were performed during ongoing mechanical ventilation at different levels of~     endexpiratory pressure.~   "
38243|NCT02556489|"~     Analyse the transcriptomic signature of anti vaccinia memory B cells at a short time after~     vaccination as compared to the signature already established in long-lived memory B cells.~   "
11895|NCT02901457|"~     Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive~     to accomplish the perfect body. At the same time, only 50 % meet the government`s~     recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has~     unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical~     and psychological health. These factors, along with the pressure to obtain the perfect~     body, are threatening the adolescent`s physical and psychological health, jfr. Meld St nr~     19. It is now a need for knowledge on how the investigators can contribute to promote~     positive body experience among the adolescents.~      It has recently, through a controlled study on elite youth athletes at Norwegian sports high~     schools, been shown that it is possible to change eating habits, improve body image and~     reduce new cases of eating disorder. It is now desirable to test an adapted program through~     a school-based program at regular Norwegian high school students (12th grade). Today, no~     controlled, school-based intervention studies with long-term follow-up have been conducted.~      The main aim of this project is to investigate if it is possible, through a school-based~     intervention program (Healthy Body Intervention), to promote positive body image, increase~     physical activity level, and healthy eating and sleeping habits in both boys and girls at~     Norwegian high schools.~      The intervention program will contribute with new evidence-based knowledge on the effect of~     an adapted health-promoting program.~   "
11896|NCT02901444|"~     Stemming from the common practice of attribution of the technical helps in the posture in~     Canada, the multidisciplinary approach of positioning develops in France for more than 10~     years old.~      To date, no observatory study was led to estimate the impact of such consultation in daily~     activities, an essential objective conditioning the observance and the acceptance of~     assistive devices. This study wants to estimate the impact through modification of WHOM~     scale.~   "
11897|NCT02901431|"~     This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group,~     placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of~     RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning~     (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered,~     starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12~     years). Initially, a first cohort of approximately 24 adolescents will be enrolled together.~     Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort~     and determined final doses, enrollment of adolescents will resume and the enrollment of a~     first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on~     acceptable safety and tolerability in the first children cohort and determined final doses,~     enrollment of children will resume.~   "
11898|NCT02901418|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important~     reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is~     the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine~     immediately after birth is the most important method of blocking mother-to-child~     transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine~     blocking measures still have a failure rate as high as 5% ~ 15%.There are numerous studies~     to explore pregnancy women with HBV positive, especially high viral load of those women~     during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV~     MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the~     efficiency of personalized blocking method of HBV maternal-neonatal transmission in~     high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.~   "
11899|NCT02901405|"~     This randomised controlled trial aims to evaluate the difference in surgical site infection~     following excision of soft tissue sarcomas. The intervention is a negative wound pressure~     therapy dressing for 120 hours, the control is standard absorbent dressings~   "
11900|NCT02901392|"~     Stress urinary incontinence is a significant potential source of morbidity after radical~     prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary~     sphincter remains the preferred therapeutic option. However, this technique is not free from~     complications. In an attempt to avoid such complications, male sling has been suggested for~     use in patients with mild degrees of stress incontinence.~   "
11901|NCT02901379|"~     The purpose of this study is to determine whether atorvastatin 80mg can reduce the~     development of myocardial edema following coronary artery bypass surgery.~      This study also want to determine:~        1. whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level~          following bypass surgery?~        2. whether there is correlation between myocardial edema and FSTL1 plasma level?~        3. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in reducing hs-CRP~          (high sensitive-C reactive protein) and MDA (malondialdehyde) plasma level following~          bypass surgery?~        4. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB~          plasma level following bypass surgery?~   "
11902|NCT02901366|"~     To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites~     of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.~   "
11903|NCT02901353|"~     A prospective, single-arm, multi-centre, observational, real world registry to evaluate~     safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for~     very long coronary lesions.~   "
11904|NCT02901340|"~     The purpose of the study is to investigate third trimester fetal renal artery doppler~     indices in borderline idiopathic isolated oligohydramnios and relationship between neonatal~     outcomes.~   "
11905|NCT02901327|"~     Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the~     general population. Multifidus muscle inhibition accompanying CMLBP plays a major role in~     perpetuating the pain and functional disability. Lumbar stabilisation and treadmill~     exercises are established treatments for CMLBP. However, it is not known which of the two~     techniques is more effective. This study was conducted to compare the effects of lumbar~     stabilisation and treadmill walk on multifidus activation, pain and functional disability in~     individuals with CMLBP.~   "
11919|NCT02901145|"~     patients with progressive/relapsed solid tumors who failed first line therapy , will be~     treated biweekly with the anti PD1- Nivolumab. at least one month after treatment initiation~     low dose cyclophosphamide will be started .~      patients on trial will submit tissue and blood tests for whole exome an immune genomic~     signature. patients will also undergo repeated immunophenotype as part of follow up.~   "
11906|NCT02901314|"~     Non-adherence to the heart failure (HF) plan of care after hospital discharge has been~     associated with clinical outcomes, including the combined endpoint of all-cause mortality~     and rehospitalization for decompensated HF. Patients and informal caregivers receive~     education materials but may not act due to multiple factors. A recorded message that could~     be repeatedly played by patients and caregivers might increase adherence to post-discharge~     self-care behaviors and early follow-up appointments, and have clinical benefits related to~     a reduction in all-cause mortality and rehospitalization. The purposes of this randomized,~     controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand~     Audio Discharge) card, given to patients at discharge. The aims of this single-blind,~     placebo-controlled study are to examine the effects of recorded messages that can be~     replayed post discharge (delivered via the MyROAD card) on multiple subjective and objective~     clinical outcomes.~   "
11907|NCT02901301|"~     Gastric cancer is one of the major health problems worldwide, and one of the leading cause~     of death especially in Asia. Though the cytotoxic chemotherapy is the main treatment option,~     newer and molecularly targeted agents are recently incorporated to improve the survival~     outcome. Human epidermal growth factor receptor 2 (HER2, ErbB2) is a transmembrane tyrosine~     kinase receptor and is overexpressed or amplified in 10-20% of gastric cancer. Recently,~     Trastuzumab for Gastric Cancer (ToGA) study reported the clinical benefit of trastuzumab for~     HER2 positive gastric cancer patients. However, because the majority of patients develop~     intrinsic or acquired resistance within 1 year, elucidating the molecular mechanisms for~     trastuzumab resistance is warranted to improve the survival outcome of HER2 positive gastric~     cancer patients.~      A growing body of preclinical and clinical evidence shows that the immune system contributes~     substantially to the therapeutic effects of monoclonal antibody, trastuzumab in solid~     tumors. Pembrolizumab is a potent and highly selective humanized monoclonal antibody~     designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.~      Based on strong rationale in exploring the impact of combining trastuzumab with anti-PD-1~     inhibitor in HER2 positive cancer, we suggest multicenter phase IB/II study to determine~     antitumor activity and safety of pembrolizumab in combination with standard treatment~     (trastuzumab, capecitabine, and cisplatin) in patients with HER2 positive gastric cancer.~   "
11908|NCT02901288|"~     The purpose of the study is to evaluate the safety and efficacy of two shortened regimens~     for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to~     World Health Organization recommended standard 6-month regimen.~   "
11909|NCT02901275|"~     This research is being done to evaluate whether combining medications that are FDA approved~     but have not yet been approved for combination treatment, can be an effective way to reduce~     pain.~   "
11910|NCT02901262|"~     To evaluate the ability of NICU staff to interpret, before and after a training period,~     symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG tracings.~   "
11911|NCT02901249|"~     To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using~     medications available in the Brazilian Public Healthcare System (SUS), and assessment of the~     quality of life of these patients.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of unipolar depression episodes.~   "
11912|NCT02901236|"~     Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical~     success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This~     prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing~     modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral~     delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy~     with anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).~   "
11913|NCT02901223|"~     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its~     impact on patient satisfaction and is it worthy for general breast surgeon to learn~     different oncoplastic techniques.~   "
11914|NCT02901210|"~     The aim of this study is to evaluate the investigator new modification for delorme procedure~     in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .~   "
11915|NCT02901197|"~     The purpose of this dual-site quasi-experimental pilot study is to evaluate if the~     implementation of an educational intervention paired with an environmental assessment to~     address accessibility barriers is associated with improvement in staff knowledge and skills,~     and adherence to national guidelines for use (evaluation in the knowledge transfer~     framework) in an emergency department (ED) setting.~   "
11916|NCT02901184|"~     Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without~     therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart~     Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF,~     but it is generic and will not be studied by industry.~      SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will test the hypothesis~     that spironolactone reduces all-cause mortality in HFPEF and is summarized by PICO (Patient~     Intervention Comparison Outcome) as follows: Population: HFPEF patients in the Swedish Heart~     Failure Registry. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type~     Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention~     and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual~     care alone.~      Outcome: Primary outcome all-cause mortality. Secondary outcomes include hospitalization for~     various causes, adverse events and treatment adherence. Outcomes are obtained automatically~     by linking with the Population, Patient and Drug Dispension Registries. The trial is~     event-driven with enrollment 3 years and study duration 5 years. Based on actual patients~     meeting eligibility 2008-2010, the control death rate is 0.141 / year. Based on TOPCAT and~     accounting for dropouts, the investigators conservatively assume hazard ratio 0.85, or a~     clinically meaningful 15% reduction in death, yielding a required number of events of 1208~     and a sample size of 3335, conservatively rounded to 3500. A detailed feasibility assessment~     shows that there will be > 8197 eligible patients to meet the required enrollment of 3500.~   "
11917|NCT02901171|"~     The purpose of this study is to evaluate the efficacy of a smartphone application in~     enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This~     study also aims to elucidate the processes through which the treatment promotes smoking~     cessation and for whom it is most effective.~   "
11920|NCT02901132|"~     Malnutrition in oncologic patients has a negative impact on post- surgical recovery,~     survival and quality of life. The etiology of malnutrition in cancer patients is~     multifactorial, therefore, the nutritional assessment should be carried out by different~     parameters. The objective of this study is to investigate the association and prognostic~     value of five distinct methods of nutritional assessment (molecular, body composition,~     functional, anthropometric and subjective) in relation to postoperative complications and~     short-term survival in patients with cancer. Regarding the molecular parameter, mtor~     signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of~     the operation. Body composition was assessed by computed tomography (CT) and bioelectrical~     impedance test was conducted to evaluate the phase angle. Handgrip strength was used to~     determine functionality. The percentage of weight loss in relation to usual weight was the~     anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the~     nutritional diagnosis. Postoperative complications were classified according to the Dindo~     and Clavien classification. Overall time survival was the period between the first~     assessment of the patients until death or end of follow-up. Chi-square test, t test,~     Kaplan-Meier method and the Log Rank test and regression analysis will be used (p <0.05).~   "
11921|NCT02901119|"~     Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or~     metabolic alterations modify the body composition and biological functions. The purpose of~     this study is to determine whether whey protein comsumption, due to amino acid profile,~     digestibility and bioactive compounds may be beneficial for patients waiting for liver~     transplantation~   "
11922|NCT02901106|"~     The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting~     multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two~     randomised, placebo phase-controlled III international studies, organized by the~     pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received~     European approval on January 30, 2014, for the treatment of adult patients with relapsing~     remitting MS.~      Treatment with dimethyl fumarate is introduced as part of the usual care under supervision~     of a physician experienced in the treatment of the disease.~      It has proved effective to reduce the number of relapses in patients with~     recurring-remitting MS and reduce the number of patients who have relapses during treatment.~      The objective of the study is to observe, in real conditions, on the one hand the tolerance~     and the other evolution, clinical and radiologic disease in patients already treated by~     dimethyl-fumarate and collect long-term safety data.~   "
11923|NCT02901093|"~     Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is~     usually performed to identify an underlying cause, such as excessive intravestibular~     penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.~      Unfortunately, there is very little data in an unselected series of uneventful patients.~      The aim of this study is to analyze the depth of prosthesis penetration within the vestibule~     and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone~     Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate~     imaging findings to clinical outcome. This prospective monocentric study is conducted in a~     tertiary referral medical center. A CBCT is performed in 80 consecutive patients having~     undergone stapes surgery for otosclerosis, the day or the day after the procedure.~     Penetration length and location of the prosthesis within the vestibule, as well as presence~     or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo,~     nystagmus, hearing measurement).~   "
11924|NCT02901080|"~     This is a single-centre research study in patients seen within an NHS Improving Access to~     Psychological Interventions (IAPT) service with suspected generalised anxiety disorder~     (GAD). The study will involve 120 patients from the Leicestershire and Rutland area in~     England, United Kingdom.~      Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical~     device, which is approved for use and proven to be safe and work for the treatment for~     anxiety, depression and insomnia.~      Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either~     whilst on the waiting list for standard care treatment from IAPT, or in conjunction with~     standard care treatment from IAPT.~      The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits~     via telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to~     complete questionnaires to assess anxiety, depression, sleep difficulty, quality of life and~     work and social functioning.~      The purpose of the study is to gather evidence for the clinical benefits and cost~     effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and~     does it's use result in cost savings for the NHS.~      The study may show that the Alpha-Stim AID should be available on the NHS for patients with~     suspected GAD.~   "
11925|NCT02901067|"~     This is a phase II, pragmatic, prospective, randomized, double-blind, adaptive clinical~     trial examining the efficacy of statins and aspirin in the reduction of acute lung injury~     and venous thromboembolism in patients with fibrinolysis shutdown.~   "
11926|NCT02901054|"~     Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing~     after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron~     might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by~     investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability~     that may affect that distribution.~      Study procedures will include iv ondansetron administration, serial blood draws,~     cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.~   "
11939|NCT02900482|"~     The main objective is to identify the genes involved in congenital dislocation of the hip.~      The secondary objectives are to measure the association between mechanical risk factors and~     congenital dislocation of hip and study the interactions between these factors and genetic~     factors.~   "
11940|NCT02900469|"~     The purpose of this study is to determine whether one dose of denosumab can lead to changes~     in the tumor, which may decrease the ability of tumor to spread.~   "
11986|NCT02900547|"~     The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart~     Failure will be enrolled and health data will be collected at hospital admission and during~     hospital stay. No data will be collected before detailed information is given to the patient~     and a non-opposition is obtained.~      The aim of this observational and prospective study is to evaluate the concordance actual~     patient management during the in hospital treatment of heart failure and the therapeutic~     proposals from a medical algorithmic decision support software.~   "
11927|NCT02901041|"~     Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000~     deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however,~     approved medications for the treatment of AUD has shown limited effectiveness.~      Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a~     placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism~     of action seems to be quite distinct from currently approved anti-alcoholism medications,~     which holds promise for treatment of individuals who are not responsive to conventional~     medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's~     efficacy in treating patients with a diagnosis of AUD.~      To fill in these gaps, the investigators will conduct a double-blind randomized controlled~     study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol~     consumption in patients with AUD. Participants will be randomized to one of two conditions:~     1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2)~     treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential~     therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC~     versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as~     well as an alcohol related cues task.~   "
11928|NCT02901028|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according~     to the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs,~     blood physiologies, oxygen consumption, biomechanics, strength, neurological capabilities,~     and balance in a population of athletes wearing the Device. Secondly, to determine the~     tolerance and acceptance of the Device while undergoing exertion.~   "
11929|NCT02901015|"~     Interventional, multicenter, and longitudinal study, of a cohort of patients with~     schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12~     months interval.~   "
11930|NCT02901002|"~     In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected~     are frequently found. Pain and sensory perturbation seems to modify the way patients~     perceived their body part affected.~      Does a local body image perturbation can affect the balanced of the global self-awareness?~   "
11931|NCT02900989|"~     The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions~     composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use~     of this brief valid screening instrument could assess the risk for suicide in pediatric~     patients and then improve the prevention of suicidal tendencies in this population.~   "
11932|NCT02900976|"~     This pilot clinical trial studies how rituximab and latent membrane protein (LMP)-specific~     T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive,~     cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder.~     Monoclonal antibodies, such as rituximab may block tumor growth in different ways by~     targeting certain cells. LMP-specific T-cells are special immune system cells trained to~     recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they~     are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may be~     better in treating pediatric organ recipients with post-transplant lymphoproliferative~     disorder than rituximab alone.~   "
11933|NCT02900963|"~     Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or~     associated to surgical treatment. Early (during treatment or the following weeks) and late~     side effects contribute to malnutrition in this population at risk. In this context,~     nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or~     gastrostomy) are often necessary. The early identification of the patients with high~     malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and~     efficacy of treatment. This prospective study research the factors of malnutrition during~     head and neck radiotherapy.~   "
11934|NCT02900950|"~     A single-centre, randomised clinical trial of patients affected by periampullary cancer who~     underwent pancreaticoduodenectomies which included two different types of specimen~     margination: arm A (multicolour inking) and arm B (monocolour inking). The randomisation of~     the specimen was made after the resection, blinded for the surgeons involved in the~     operation. The primary endpoint was the overall R1 resection rate and its difference between~     the two arms. The secondary endpoints were the R1 resection rate in each margin and its~     difference between the two arms, and the impact of margin status on survival. A sample size~     of 18 patients was required.~   "
11935|NCT02900937|"~     The purpose of this study is to evaluate the safety and performance of a new version of a~     coronary artery stent for treating blockages in the arteries supplying blood to the heart~     muscle. The Amaranth Medical MAGNITUDE scaffold releases a drug (sirolimus) to reduce the~     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold~     dissolves away over time, leaving no permanent implant after the blood vessel has healed.~   "
11936|NCT02900924|"~     The MIMICS-3D study will evaluate safety, effectiveness and device performance within a~     real-world clinical population of patients undergoing femoropopliteal intervention.~   "
11937|NCT02900911|"~     Head and neck cancer has a negative impact in swallowing function and quality of life.~     Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies~     suggest that interventions should be initiated prior to RT sessions. This study aims to~     evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The~     study pretends to establish a preventive rehabilitative program with the target of reducing~     RT side effects and improve patients' quality of life.~   "
11938|NCT02900898|"~     Rheumatoid arthritis (RA) is a chronic autoimmune disease with metabolic alterations due~     mainly by the liberation of catabolic cytokines leading to changes in body composition as~     rheumatoid cachexia. Dynamic exercise (DE) has demonstrated to improve muscular, strength~     and joint function as well as inflammatory process. Also, a diet focused on the consumption~     of certain fatty acids like the Mediterranean is recommended to reduce inflammation. The aim~     of this study is to assess the effect of a dynamic exercise program in combination with a~     Mediterranean diet in strength, joint mobility and disease activity in women with RA.~   "
11941|NCT02900456|"~     Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care~     Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation~     in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications~     stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc.~     Several papers recently questioned the relevance of this assistance device - namely the~     IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in~     the downgrading of the recommendation standards of the IABP by medical societies.~   "
11942|NCT02900443|"~     Rationale: Current standard therapy of autoimmune hepatitis consists of a combination of~     prednisolone and azathioprine. However, a significant proportion of patients does not~     respond to, or is intolerant for, azathioprine. Mycophenolate mofetil (MMF) has surpassed~     azathioprine as therapy to prevent organ transplant rejection and is sometimes used as an~     alternative option for autoimmune hepatitis. Several case series and one prospective study~     have documented the efficacy and safety of mycophenolate mofetil as induction therapy for~     autoimmune hepatitis. Robust evidence from a formal randomized clinical trial is lacking.~      Objective: To assess the efficacy and safety of mycophenolate mofetil as induction therapy~     in patients with treatment naive autoimmune hepatitis.~      Study design: Multicenter, randomised, open-label intervention study Study population:~     Patients with newly diagnosed autoimmune hepatitis who are in need of induction therapy~     according to current guidelines.~      Intervention: The intervention group will receive oral mycophenolate mofetil for 24 weeks.~     The control group will be treated with azathioprine for 24 weeks. Both groups will be~     treated with steroid induction which will closely follow the schedule from the recent~     Clinical Practice Guidelines by the European Association for Study of the Liver (EASL).~      Main study parameters/endpoints: The primary outcome is the proportion of patients in~     remission, defined as normalization of serum alanine transaminase (ALT) and immunoglobulin G~     (IgG) levels after 24 weeks of treatment, per treatment group. Secondary endpoints include~     safety and tolerability of mycophenolate mofetil, time to remission, changes in Model For~     End-Stage Liver Disease (MELD) -score (and its components bilirubin, INR, creatinine),~     albumin, pseudocholinesterase and N-terminal procollagen-III-peptide, ELF (Enhanced Liver~     Fibrosis) -score and aspects of quality of life. In a sub-study, drug levels will be~     measured.~   "
11943|NCT02900430|"~     Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose~     invasive aspergillosis (IA). These infections are leading to an important morbidity and~     mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during~     neutropenia induced by induction chemotherapy. Their application is not uniform.~   "
11944|NCT02900417|"~     The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive~     sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the~     composition of gut microbiota before and after the therapy of sitagliptin.~   "
11945|NCT02900404|"~     This study shall determine whether XAPPORT - a mobile device app based on different~     guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and~     practice - provides adequate guidance to physicians attending patients undergoing elective~     surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to~     approach the pre- and postoperative management of anticoagulation.~   "
11946|NCT02900391|"~     Elderly population is increasing quickly and their need for health care ressources through~     emergency care is also growing. While these patients are ageing physical impairment often~     happens along the way. Apart from senior homes, different types and levels of home care~     services have been developped in order to overcome or to adapt to these situations.~      Our goals are:~        -  to assess mortality rate depending on home care services level for the elderly~          population consulting in the ED or being taken in charge by the Emergency Medical~          System in France.~        -  to describe this population in terms of autonomy, impairment and home care services~   "
11947|NCT02900378|"~     The purpose of this randomized, actively controlled, double-blind study is to demonstrate~     the superiority of sacubitril/valsartan over enalapril in increasing non-sedentary physical~     activity chronic heart failure patients with reduced ejection fraction. Physical activity~     will be continuously measured by means of a wrist-worn accelerometry device from 2 weeks~     before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).~   "
11948|NCT02900365|"~     In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury with~     IOL implantation underwent early and 30 eyes underwent late cataract surgery. We excluded~     patients who were under 12-year-old. All patients were visited at 1week, 4 weeks , 12 weeks~     and six months after surgery. In each visit, patients were examined regarding visual acuity,~     intraocular pressure (IOP), anterior chamber inflammation, IOL position and posterior~     synechiae. In addition, posterior segment evaluation and funduscopy were performed.~     Intraoperative complication including posterior capsular rupture, anterior vitrectomy and~     zonulysis as well as the site of IOL implantation were documented and postoperative~     complications including raised IOP, anterior chamber inflammation, visual axis opacity,~     posterior synechiae, subluxation of IOL, IOL pigment deposition were listed.~   "
11949|NCT02900352|"~     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication~     zonisamide for the treatment of heavy drinking alcoholic civilians.~   "
11950|NCT02900339|"~     Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays)~     imaging modality. Today it is considered an anatomical and functional exploration reference~     technique. Since its inception around 1985, this technology is constantly evolving.~      Many advances in MRI require constant adaptations of radiological practices. The~     morphological image is now associated with functional and parametric information (infusion,~     diffusion spectroscopy, etc ...). In parallel, work combining acquisition and~     post-processing of data also open new applications (tractography, functional MRI, etc ....).~     Thus, more and more procedures are necessary to integrate these techniques for the~     diagnosis and adapt to new demands of clinicians.~      The type of sequence and its associated parameters allow to directly influence the contrast~     of images, to characterize tissue compared to another and, ultimately, to highlight~     morphological or functional abnormality. Image quality can be optimized on each MRI,~     depending on the time available for the acquisition on the one hand, and on the desired~     resolution and contrast, on the other hand. For each sequence, it is therefore necessary to~     find a compromise that will optimize the diagnostic quality of the examination.~      This optimization requires a phase focusing on healthy volunteers. It is therefore important~     that researchers and physicists could design on healthy volunteers, the best settings of all~     parameters for an image or spectrum. Indeed, it is always necessary to properly optimize~     every parameter choices before beginning a study of a cohort of patients.~      In this context, the main objective of this study is to optimize sequences and imaging~     protocols to evaluate and validate the choice of parameters in healthy volunteers.~   "
40088|NCT02532257|"~     The goal of this clinical research study is to learn if adding Imbruvica (ibrutinib) to~     Rituxan (rituximab) and Revlimid (lenalidomide) can help to control previously untreated FL.~   "
11951|NCT02900326|"~     Integrative approaches to promote wellness and reduce the distress associated with cancer~     are considered as essential components of cancer care. In case, exercise training has been~     shown to produce many positive physiological and psychological benefits. Mindfulness-based~     stress reduction program shows similar beneficial effects, and especially in emotional~     distress management. The aim of the study is to examine the cumulative effect of an 8~     week-exercise-training program combined with an MBSR program on cardio-respiratory fitness~     and quality of life in women with breast cancer. These effects are thought to be mediated in~     part through changes in underlying brain processes, that investigators will be put in light.~     Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine~     level measurements, investigators could expect to better understand the effect of these~     combined training in breast cancer.~   "
11952|NCT02900313|"~     Cardiac surgery associated acute kidney injury is an independant factor of morbidity and~     mortality . Despite its delayed elavation, serum creatinine (Cr) remains the goal standard~     to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion~     decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its~     variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of~     renal function in this context. Consequently, the purpose of this study is to evaluate the~     predictibilty of Ph to detect both AKI induction and in a second time, renal recovery.~   "
11953|NCT02900300|"~     The first aim of the study is to obtain from chirurgical micro biopsy myoblast in culture~     which will differentiate in Diaphragm fiber. Then these fibers will be submitted under~     mechanical stress condition similar to those imposed in vivo by mechanical ventilation to~     validate in human a model in vitro of diaphragm dysfunction induced by mechanical~     ventilation. Then the second part of the study will be to evaluate with this model, the~     efficiency of an antioxidant therapy.~   "
11954|NCT02900287|"~     Cancer survival is important to determine prognostic of patients and evaluate care and~     prevention health strategies. Sucre is the first study to describe cancer survival in~     Reunion Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by~     cancer site and gender. Sucre is a retrospective cohort study of cancer diagnosed between~     01/01/1998 and 31/12/2008.~   "
11955|NCT02900274|"~     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent~     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis~     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)~     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1,~     P2 & P3)~   "
11956|NCT02900261|"~     This study will compare different methods (24 hour urine collection, evening and morning~     spots, and questionnaires) to measure the consumption of sodium and cafeine in children and~     adolescents.~   "
11957|NCT02900248|"~     Registry participants with advanced malignancy or myelodysplasia will have a sample of their~     tumor or tissue analysed for genetic alterations using next generation sequencing (NGS)~     performed in a lab that has been certified to meet a high quality standard. Treatments and~     outcomes will be reported to the registry to allow further understanding of how genetic~     differences can lead to better diagnosis and treatments.~   "
11958|NCT02900235|"~     The purpose of this study is to investigate the absorption, metabolism and excretion of~     MT-3995 in healthy subjects.~   "
11959|NCT02900222|"~     The purpose of this study is to determine whether endoscopic choroid plexus coagulation is~     safe in adult patients with communicating hydrocephalus and risk factors for complications~     from the standard surgical treatment. It may also help determine whether the endoscopic~     choroid plexus coagulation is effective in treating your communicating hydrocephalus. The~     Investigators hope that this research will allow us to place fewer shunts in patients with~     conditions similar to yours, avoiding complications.~   "
11960|NCT02900885|"~     Retrospective medical chart and medical imaging file review of patients suffering from palsy~     of the superior rectus extraocular muscle~   "
11961|NCT02900872|"~     Systematic retrospective study of medical charts and medical imaging files, of patients~     consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel~     imaging.~   "
11962|NCT02900859|"~     Systematic medical chart and imaging files review of patients presenting with non-lymphoma,~     non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI~     infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic~     disease (IgG4-ROD) and other patients.~   "
11963|NCT02900846|"~     Retrospective medical charts and medical imaging files review of patients suffering from~     lacrimal fossa lesions who underwent ocular ultrasonography with color flow doppler imaging.~   "
11964|NCT02900833|"~     Clinical and experimental data suggest that neutrophil activation and extravasation are~     deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable~     outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil~     recruitment in AIS patients were negative. Recently, an experimental study has shown that~     neutrophil activation and transmigration begin immediately after the occlusion. Inhibition~     of neutrophil recruitment several hours after the start of ischemia appears therefore too~     late to have a clinical relevance.~      The objective is to study the time dependent impact of neutrophils in AIS and the~     predominant mediators in each time point to identify the appropriate therapeutic target and~     time window.~   "
11971|NCT02900742|"~     The investigators performed a randomized, prospective study method on observation of~     Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the~     efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The~     investigators plan to involve 100 cases for observation in 3 years (50 cases for~     chemotherapy maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that~     integrated TCM combined with chemotherapy maintenance has a better efficacy on prolonging~     progression-free survival time, overall survival, improving quality of life(QOL) of patients~     than that of chemotherapy maintenance.~   "
11997|NCT02900131|"~     Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence.~     Complementary and alternative medical approaches have been employed to relieve symptoms of~     Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in~     patients with Atopic Dermatitis.~   "
11965|NCT02900820|"~     There is no evidence that discontinuing antibiotic therapy for non-bacterial infections is~     safe. The main objective of this study is to determine whether discontinuation of antibiotic~     therapy when a clinician no longer considers it necessary makes any difference in terms of~     the number of days with severe symptoms. This is a multicentre, open-label, randomised~     controlled clinical trial. The study will be conducted in ten primary care centres in Spain.~     We will include patients from 18 to 75 years of age with uncomplicated acute respiratory~     tract infections (RTIs) in whom: antibiotics are not necessary; or those diagnosed with~     clinical conditions for which antibiotics might be necessary but according to the history~     and clinical examination the physician considers that antibiotics are not needed or the~     patient feels that the antibiotic regimen has not worked as expected; or several doses of an~     antibiotic have been taken from leftovers found in the household or obtained at the pharmacy~     without any medical prescription for a clinical condition for which antibiotics are not~     necessary. The patients will be randomly assigned to the usual strategy of continuing~     antibiotic treatment (usual intervention group) or discontinuing antibiotic therapy (novel~     intervention group). A sample size of 215 patients per group was calculated on the basis of~     a reduction of one day in the duration of severe symptoms as a clinically relevant outcome.~     The primary outcome will be duration of severe symptoms, i.e. symptoms scored 5 or 6 by~     means of a symptom diary. Secondary outcomes will include: antibiotics taken, adverse~     events, patient satisfaction, and complications within the first 3 months.~   "
11966|NCT02900807|"~     Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is~     intubated, the endotracheal tube must be inserted into the trachea to the right depth. If~     the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to~     the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective~     intubation into the right or left mainstem bronchus, which can lead to contralateral lung~     atelectasis and hypoxemia.~      The purpose of this study is to determine whether there is a correlation between the~     measurement of the airway of an adult population and criteria that would be easily~     accessible in daily clinical practice: the height of the patient and the size of their feet.~   "
11967|NCT02900794|"~     Sinusitis is a common medical problem, which significantly decreases patients' quality of~     life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion~     and drainage, decreased sense of smell, and malaise. Surgical therapy for sinusitis attempts~     to restore the sinus health by directly relieving sinus obstruction. Small telescopes,~     called endoscopes, are placed through the nostrils into the nasal cavity to enhance~     visualization, illumination, and magnification of the sinuses and adjacent structures. There~     are a variety of surgical instruments available to a surgeon for ESS such as stainless steel~     tools (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy~     has been shown to improve QOL, decrease medication use and days missed at work for subjects.~     The use of lasers in treatment of chronic sinus infections is well documented. The LF-40~     Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use~     in various procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing),~     post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped~     ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for~     1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization~     of the turbinates and compare postoperative outcomes with the use of a microdebrider. These~     uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times~     are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.~   "
11968|NCT02900781|"~     Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of~     the knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee~     Arthroplasty performed in a population that is aging during a time where the amount of~     healthcare dollars allotted to rehabilitation is declining, there is a need to develop~     remote monitoring of rehabilitation and to engage and optimize self-management of recovery.~      Current management of Partial or Total Knee Arthroplasty recovery is typically performed in~     the out-patient setting and is highly protocol driven. A typical case might be seen by the~     physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor~     progress (i.e. compliance with ROM and strengthening exercises). One recent study suggested~     that variation in patients' independent exercise and activity after arthroplasty surgery may~     contribute to variable functional gains.~      The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert~     that collects functional data) will reduce cost and improve the efficacy of rehabilitation~     in total knee arthroplasty patients~   "
11969|NCT02900768|"~     Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment~     option for malignant hematological diseases, it is also associated with significant~     morbidity such as graft versus host disease, infections, and immune complications. Moreover,~     long-term survivors are likely to have reduced physical performance and functioning due to~     deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and~     psycho-social stress, all of which negatively impact patients' quality of life.~      Purpose: To conduct a randomized controlled, single site trial investigating whether a~     partially supervised exercise intervention in the first 100 days post alloHSCT patients will~     result in improved quality of life at Day 100 post-transplant compared to standard of care~     treatment. Secondary objectives will investigate the effect of an exercise intervention on~     muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body~     composition, exercise, and immunological/inflammatory biomarkers compared to standard of~     care.~      Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into~     an Exercise Intervention Group or Standard of Care Control Group.~   "
11970|NCT02900755|"~     Perampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment~     of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective~     non-competitive antagonist of AMPA receptors.~      Evaluating adverse effects during the introduction of new AED is often difficult since the~     complaints are subjective and objective assessment is complicated due to the polytherapy.~     Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs~     because of the correlation of EEG analysis results and side effects of AED such as cognitive~     slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms~     of EEG background spectra and to evaluate perampanel effects by using subjective~     questionnaires assessing depression, anxiety, sleep quality and fatigue.~   "
11972|NCT02900729|"~     Hypertension represents a significant global public health problem, contributing to vascular~     and renal morbidity, cardiovascular mortality, and economic burden. For a mostly~     asymptomatic disease, there is a huge challenge to maintain a good adherence and longtime~     persistence of drug use so as to adequately control it. Even so, a significant proportion of~     patients will develop resistant hypertension. In recent years, renal denervation has been~     argued as an effective means to address blood pressure problem in several non-Chinese~     clinical trials. The technique is to deliver low level radiofrequency energy through the~     renal artery wall to target the sympathetic nervous system and then modulate blood pressure.~      Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which~     is an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to~     improve blood pressure status among patients with resistant hypertension failing~     polypharmacy. The purpose of this randomized control trial is to obtain an assessment of the~     efficacy and safety of WiseGo renal denervation technique in the presence of three standard~     antihypertensive medications in Chinese patients.~   "
11973|NCT02900716|"~     This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of~     an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia~     or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in~     combination.~      This study will be conducted in two parts: phase Ia and Ib. Both parts will explore~     escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy.~     The phase Ib study will evaluate DTRMWXHS-12 combinations.~   "
11974|NCT02900703|"~     -  Epidemiological studies have shown the diversity of resistance genotypes and the~          evolution of their prevalence in the paediatric population. This large study conducted~          in a context of very low vaccination coverage will generate more precise data on the~          natural epidemiological evolution of rotavirus, notably the G9 genotype, which has~          appeared relatively recently.~        -  This study will allow us to identify and document rare or unusual strains of human or~          animal origin. The complete genetic characterization of these strains will also make it~          possible to study their ability to recombine and to assess the risk of emergence. Among~          these still rare strains, the investigators are particularly monitoring G12 rotavirus,~          whose ability to recombine raises the risk of emergence.~        -  For at least one of the centres taking part in the study, the paediatric population~          studied will be given strong vaccination coverage. It will be extremely interesting to~          compare the results obtained in the vaccinated population with non-vaccinated children~          to assess the impact of this vaccination on the distribution of rotavirus genotypes~   "
11975|NCT02900690|"~     The main objective of this project is to assess the average cost of the treatment of~     bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the~     reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also~     avoids in some cases very costly invasive procedures. It will be interesting to compare the~     average cost of the complete strategies supported.~   "
11976|NCT02900677|"~     The aims of this three-year study are to:~        1. explore the change of fatigue, nutritional status, quality of life and care needs in~          patients with operable pancreatic cancer perioperatively and following surgery within 3~          months.~        2. develop and evaluate the effect of patient-centered cancer prehabilitation care program~          on improving fatigue, nutritional status and quality of life (QOL) in this population.~   "
11977|NCT02900664|"~     The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four~     agents with immunomodulatory activity to identify the doses and schedule for combination~     therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical~     activity of these combinations.~   "
11978|NCT02900651|"~     The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or~     recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and~     pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as~     Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced~     solid tumors for whom no further effective standard treatment is available.~   "
11979|NCT02900638|"~     The purpose of this study is to determine whether mentoring is associated with beneficial~     cardiovascular health effects in both mentors and mentees.~   "
11980|NCT02900625|"~     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who~     have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their~     fertility. The main part of the ovary is preserved, as primordial and primary follicles are~     resistant to freezing / thawing protocols. In the absence of other techniques (in vivo~     maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved~     tissue is currently the only technique allowing fertility to be restored. Autograft is~     possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or~     a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic~     pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to~     the lack of any codified technique for evaluating residual disease (MRD). The team has for~     two years been developing and validating a technique to look for residual disease in~     fragments of ovarian cortex in cases of acute leukemia. This technique is based on an~     original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian~     cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of~     the technique have been demonstrated in an experimental model. This model consists in using~     8 color flow cytometry to look for characterizable leukemia cells added in different~     dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up~     to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found~     by RQ-PCR with the same dilutions. The model tissue came from laparoscopic ovarian drilling~     in patients with polycystic ovary syndrome. The main objective of this project is to~     validate techniques that have been previously codified with different populations of~     leukemia cells that may be characterized. The investigators then aim to adapt and validate~     this technique to look for MRD using 8 color flow cytometry on cryopreserved fragments of~     ovarian cortex from leukemia patients that are at risk of metastasis. Secondary objectives~     will be to implement procedures for oncological qualification of grafts in cases of~     malignant pathology and to consider the recommendations for using this cryopreserved ovarian~     tissue through the autograft technique for these indications.~   "
11981|NCT02900612|"~     This study aims to compare the effects of two water-based training models in physiological~     parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will~     be conducted in parallel with the participation of 45 dyslipidemic elderly women.~   "
11982|NCT02900599|"~     Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to~     antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use~     various psychometric tools to determine if these scores have a predictive value on late~     testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The~     expected outcomes would be to be able to stratify patients using a behavioural risk score~     and allocate targeted ressources to improve the quality of care for the most at risk~     patients.~   "
11987|NCT02900534|"~     The purpose of this study is to evaluate the efficacy of an internet-based self-help~     intervention for older adults with prolonged grief symptoms after spousal bereavement or~     separation/divorce. The study design is a randomized trial with a waiting control condition~     of 12 weeks and a follow-up after 6 months. The investigators will test the following main~     hypotheses:~        1. The intervention group shows a significant decrease in grief symptoms, psychological~          distress, depression symptoms and embitterment, and a significant increase in life~          satisfaction, as well as session related outcomes from baseline to 12 weeks post~          intervention assessment.~        2. The effects in the intervention group are larger than the effects in the waiting~          control group.~        3. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.~   "
11988|NCT02900521|"~     The registry is the main objective exhaustive list of cases validated stroke brain on a~     geographical area defined to calculate an incidence.~   "
11989|NCT02900508|"~     The purpose of this study was to investigate the effects of virtual reality-base training~     for cerebellar ataxia.~   "
11990|NCT02900495|"~     Children referred to the pediatric urology clinic for primary nocturnal enuresis will be~     screened for enrollment. Patients who fail behavioral therapy and who meet inclusion~     criteria will be offered therapy with a TENS unit.~      Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation~     arm with electrodes placed onto the abdomen in the suprapubic region directly over the~     bladder. Group 2 will be the distal neural loop arm with electrodes placed over the~     posterior tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed~     about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be~     the control arm with electrodes placed on the scapula. We will aim to recruit 32 patients~     per group for a total of 128 patients. The patients will be provided with a TENS unit (TENS~     3000 Analog) and electrode pads and caretakers instructed on how to use the apparatus.~      The TENS sessions will be performed nightly before bed for 20 minutes. TENS units will be~     set at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the~     patient. Diaries including nighttime incontinence episodes and a wet sheet scale (dry,~     damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit.~     Patients will be followed up after one month of TENS with evaluation including the Pediatric~     Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in~     children with bladder dysfunction; this questionnaire will be filled out prior to starting~     TENS treatment in order to compare the effect of treatment on QOL. . They will then follow~     up on these parameters again after another month (one month off of TENS therapy) to assess~     the durability of treatment effect. The data will be collected at different time points~     (baseline, 1 month, 2 months) for each group by itself and the groups compared against each~     other using statistical analysis.~   "
11991|NCT02900209|"~     The aim of this study is to determine responses of the immune system to the annual flu~     vaccination in people with COPD who experience frequent or infrequent exacerbations and~     healthy participants. We will collect blood and saliva immediately before and one month~     after flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly~     antibodies (that provide protection against infection) develop in the blood after~     vaccination we can provide important new information to help confirm whether those prone to~     COPD flare ups have weaker immune systems.~   "
11992|NCT02900196|"~     The purpose of this clinical study is to evaluate the effect of a four-week consumption of a~     fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea~     and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori~     eradication.~   "
11993|NCT02900183|"~     Patients with Alpha-1 Antitrypsin Deficiency (AATD) will be enrolled to receive multiple~     doses of ARC-AAT Injection. All subjects will require a pre-dose biopsy and a biopsy post~     last dose.~   "
11994|NCT02900170|"~     Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners~     which leads to kidney dysfunction. A recent review suggests that kidney function should be~     assessed (by measuring serum creatinine) serially in the first few months of starting a~     blood thinner. ARN is diagnosed when there is a decline in kidney function after starting~     the blood thinner and other possible causes of this decline have been excluded. ARN has~     mainly been studied in relation to the common blood thinner - warfarin, where the prevalence~     is variable but can be as high as 37% (approximately 1 in 3) in the patients at highest~     risk. The risk factors that make this side effect more likely include the presence of~     pre-existing kidney disease, high blood pressure, older age and diabetes mellitus. Studies~     have shown that the occurence of ARN can lead to an accelerated progression of pre-existing~     kidney disease and a 65% increase in the risk of death (mortality).~      The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been~     recently approved for use as blood thinners. They have a faster onset of action compared to~     warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most~     commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case~     reports that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is~     no study that has determined the true incidence of ARN in NOACs. Our study is designed to~     find out the incidence of ARN in patients who are started on rivaroxaban.~      The investigators intend to serially monitor the kidney function of 40 high risk patients~     who are recently started on rivaroxaban over a six month period. This will enable us to~     discover how many patients actually develop ARN after starting a NOAC. The information the~     investigators will obtain from this study will enable patients and health care providers~     make better decisions about using blood thinners. If the investigators find that the~     incidence of ARN with rivaroxaban is less common than that previously reported with~     warfarin, it can potentially make more patients use the NOACs and hence save them from the~     morbidity and mortality associated with ARN. Our study is unique because this will be the~     first study focused on ARN in one of the new blood thinners. The information the~     investigators get from this study will be a very important foundation for future studies.~   "
11995|NCT02900157|"~     This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK,~     immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid~     tumors.~   "
11996|NCT02900144|"~     The main purpose of this trial is to develop and investigate the effects of a modified~     comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents~     with chronic tic disorders and ADHD.~      CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the~     benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively~     associated with effect size in behavioral treatments for tics. Additionally, while tic~     disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.'~     Despite improving tics, measures do not show associated improved quality of life. Currently,~     there are no standardized behavioral treatments for tics that account for ADHD symptoms~     and/or addresses the impact that tics and ADHD symptoms have on quality of life.~      The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive~     Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment.~      The second aim is to determine the treatment feasibility and acceptability (e.g. retention,~     reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment.~     The investigators will evaluate and assess the randomization process, the treatment modules,~     and the expectations and satisfaction of the participants and their parents.~      The final aim is to use a pilot randomized control trial (RCT) design to evaluate~     improvement using measures including tic, ADHD and quality of life scales as rated by a~     blinded clinician. Though the investigators will evaluate efficacy of the modified protocol,~     the primary purpose will remain feasibility. The hope is to use this study to develop larger~     trials in the future.~   "
11998|NCT02900118|"~     Breast cancers are among the cancers that metastasize the most to the skeleton. The~     appearance of bone metastasis, whether they are initials or during a relapse, is a turning~     point of the disease, due to the additional morbidity they imply (pain, pathologic~     fractures, hypercalcaemia, neurological compression, etc.). A specific treatment of these~     metastasis is often undertaken, usually a chemotherapy or hormone therapy. It is important~     to evaluate the efficacy of this treatment in order to know whether to continue or change it~     depending on the response observed. But there is no consensus at this time on paraclinical~     examinations enabling this monitoring. Also, if some criteria for assessing bone metastasis~     in imaging and nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature,~     none is formally validated and evaluation in routine practice remains subjective.~      The main objective of our study is to determine if the PET-CT and the whole-body MRI are in~     agreement on the status of bone metastasis (stability, progression, partial response,~     complete response).~   "
11999|NCT02900105|"~     The investigators hope to learn if Letrozole is effective and safe in improving severe male~     infertility by increasing testosterone, decreasing oestradiol and stimulating sperm~     production thereby improving sperm motility (movement) and concentration. The study is being~     conducted because Letrozole is not yet proven to be a standard treatment in subjects with~     absent or very low sperm counts. The investigators are hoping to determine whether Letrozole~     is equal or superior to no treatment.~   "
12000|NCT02900092|"~     Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD~     do not respond to standard antidepressant therapies despite adequate dosing. An effective~     and well-tolerated antidepressant augmentation therapy would have important clinical and~     public health implications. Neuroactive steroid hormones are known to directly activate~     neurotransmitter receptors in the brain, and thus are potential candidates for augmentation~     therapies to enhance the effect of traditional antidepressants. The investigators~     hypothesize that administration of an allopregnanolone analog in women with~     treatment-resistant depression will improve depressive symptoms.~   "
12001|NCT02900079|"~     This study is part of a larger prospective cohort study (JOKA), designed to study the~     incidence and etiological spectrum of febrile illness occurring during a travel to the~     tropics, as well as clinical course, care, treatment and outcome of these febrile illness~     episodes. Its objective is to evaluate the clinical use of malaria rapid diagnostic tests~     (RDT) by travelers or their peers during travel, as a decision aid for the management of~     febrile illness in the tropics.~      If the study demonstrates that malaria can be ruled out safely by travelers themselves using~     a RDT, a combination of self/peer testing with SBET may become an alternative to~     antimalarial chemoprophylaxis in travel medicine.~   "
12002|NCT02900066|"~     This study is part of a larger prospective cohort study (JOKA), designed to study febrile~     illness occurring during a travel to the tropics, as well as the evaluation of the clinical~     use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a~     decision aid for the management of febrile illness in the tropics.~      Filter paper blood spots and paired serology are used in addition to routine post-travel~     evaluation, to study the incidence and etiological spectrum of febrile illness occurring~     during travel to the tropics.~      The study will yield valuable and prospective data of incidence rate, the clinical and~     etiological spectrum, clinical course and outcome of febrile illness during (and~     post-)travel in a prospective cohorts of travelers. This knowledge may lead to better~     pre-travel advice.~   "
12003|NCT02900053|"~     Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure~     to a terrifying event or ordeal in which there was the potential for or actual occurrence of~     grave physical harm. Traumatic events that may trigger PTSD include violent personal~     assaults, natural or human-caused disasters, accidents, and military combat. People with~     PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep~     problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite~     high, with 7-8% in various studies and 4% in french studies.~      The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake~     inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to~     trauma-linked elements (memories, feelings and thoughts) so the fear associated to the~     traumatic event can decrease. But the therapeutic response stays partial, even combining~     these treatments.~      To improve the PTSD treatment efficiency, innovative approaches are being explored like new~     drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but~     promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation~     (tDCS) to enhance the trauma-focused therapy results.~   "
12004|NCT02900040|"~     The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in~     french, and in English Computerized and VAlidated Data in Transplantation ) cohort was~     Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes~     University Hospital in France. The primary objective of this multicenter computerized~     database was to enable prospective clinical and epidemiological research studies concerning~     kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes,~     therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort~     allows the monitoring of medical records of all patient-specific and allograft-specific~     data, including bio-banking since 2005. Data are collected from the date of transplantation~     until the graft failure, at each scheduled outpatient visit or hospital admission motivating~     by a new clinical, therapeutical or biological expression. The DIVAT cohort contains~     information on more than 11000 transplant recipients between 1994 and today, issued from 8~     French university hospitals centers (the DIVAT Network is organized by a consortium~     agreement). 18% of all patients underwent retransplantation and 11% of all kidney~     transplants originated from living donors. The DIVAT network heavily works to ensure a~     high-quality data collection with the aim of exploring adequately the complex~     post-transplantation process. The Divat network encourage collaborations and enables~     interested researchers to submit a research project by completing a request form available~     on the DIVAT website (http://www.divat.fr/en) describing the context, objectives and design~     of the study~   "
12005|NCT02900027|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS APOC-III-LRx given to healthy volunteer subjects.~   "
41305|NCT02516345|"~     This study aims to test whether incentives can motivate children to promote increased~     physical activity of a working parent while also increasing their own activity levels.~   "
12006|NCT02900014|"~     Cell therapy appears to be an alternative to treat bone defects. Scientific advances have~     shown in animal models and in humans that mesenchymal stem cells were good candidates to~     support cellular bone regeneration after transplantation. However, their collection requires~     invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone~     regeneration has recently been identified in the nasal cavity, these cells are called~     ecto-mesenchymal cells. These stem cells have very similar biological characteristics of~     mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great~     potential for differentiation into osteoblast lineage. Given their properties and their ease~     of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell~     therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells~     represent a nasal bone reconstruction interesting alternative in particular in indication of~     the cleft. They are directly and easily accessible in these children when conventional~     surgical reconstruction. The investigators propose in this study to validate a production~     method of stem cell called ecto-mesenchymal isolated from a biopsy of the nasal cavity of~     children with cleft lip and palate to be able to soon propose cell therapy innovative in~     this indication.~   "
12007|NCT02900001|"~     This study is to evaluate the efficacy and safety of early invasive strategy and routine~     delayed invasive strategy in Chinese elderly patients of 75 years or older with non-ST~     elevation myocardial infarction, and to verify the hypothesis that routine delayed invasive~     strategy is inferior to early invasive strategy in such a group of patients.~   "
12008|NCT02899988|"~     The main purpose of this study is to evaluate the efficacy of the study drug LY3074828 in~     participants with moderate to severe plaque psoriasis.~   "
12009|NCT02899975|"~     The objective of this study is to validate the prototype of the WeTakeCare- system in the~     real environment (=end users homes) and is embedded in Work-Package 4 (validation and~     evaluation) with the following main tasks:~      T4.1. Definition of methodologies and protocols T4.2. First validation: concept assessment~     T4.3. Second validation: functional assessment T4.4. Third validation: real environment~     T4.5. Final check~      Within the validation phase III of our project the investigators want to validate the~     contents of our fitness and information software WeTakeCare with the target group: elderly~     and their unprofessional caregivers. It runs on the Microsoft Kinect-System, which is~     authorised in Switzerland, and is in accordance with the prescribing information. The~     fitness- and information software contains information about strategies and devices which~     are available in case an older person is not able to perform the everyday movements in a~     safe and easy way.~      Aim of the training and information software is to support elderly to stay independent from~     others help as long as possible. The mentioned software is not a medical or therapeutical~     treatment or a medical or therapeutical product. Performed exercises or presented~     information are highly regarded in the interest of safety and protection of the~     participants, and serves to prevent physical restrictions or damage .~      There is only minimal risk or burden for the participants; the contents of the intervention~     itself (training of basic motor skills, instruction of strategies and the use of assistive~     devices to (partly) compensate restrictions in ADL performance, enablement of caregivers)~     are a standard in rehabilitation of elderly.~      The investigators expect the start of the third validation in October 2015.~   "
12010|NCT02899962|"~     A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol~     foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis~     vulgaris.~      A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind,~     2-arm, parallel group trial.~   "
12011|NCT02899949|"~     Real-world data can supplement the knowledge gained from traditional randomized controlled~     trials. To date, only a couple of studies (Andrew et al. 2014 and Wilding et al. 2015) have~     been conducted assessing the use of dapagliflozin in the real-world clinical settings in the~     United Kingdom and no research has been done on the use of dapagliflozin in Canadian~     clinical practice settings.~      To the investigators' knowledge, no real-world study exits assessing the impact of using~     dapagliflozin in conjunction with insulin in people with type 2 diabetes mellitus on dosage~     and frequency of insulin, oral antiglycemic agents and hypertension drugs. This study will~     use an electronic medical record-based data that contains demographic, drug coverage,~     vitals, lab results, medical problems and diabetes-related complications, and medication~     prescription information of patients with diabetes received care from all outpatient~     diabetes clinics in London Ontario, Canada to assess the impact of using dapagliflozin in~     conjunction with insulin in patients with type 2 diabetes mellitus on health outcomes, and~     medications dosing and frequency.~   "
12012|NCT02899936|"~     The DOLF Triple Drug Therapy for Lymphatic Filariasis study will determine the frequency,~     type and severity of adverse events following triple-drug therapy (IVM+DEC+ALB, IDA)~     compared to the standard two-drug treatment (DEC+ALB, DA) in infected and uninfected~     individuals in a community in 5 different countries. The objective is to acquire safety,~     efficacy, and acceptability data to assess the safety and acceptability of the IDA drug~     combination.~   "
12013|NCT02899923|"~     Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked~     by the production of autoantibodies against the dermal-epidermal junction or against the~     inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal~     blisters.~      The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological~     findings, including skin direct immunofluorescence.~      Systemic corticosteroid therapy is generally considered as the mainstay of treatment for~     many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.~   "
12014|NCT02899910|"~     The purpose of this study is to measure the metabolic and behavioral effects of a 12-week~     yoga program coupled to health education (HED) compared to HED alone.~   "
12023|NCT02899793|"~     Primary Objectives: To assess the antitumor activity (proportion of objective response by~     RECIST 1.1 criteria) of pembrolizumab with objective tumor response in patients with~     persistent, recurrent or metastatic endometrial cancer harboring an ultra-mutated or~     hyper-mutated (MMR gene-defective) phenotype identified by next generation sequencing (NGS)~     and comprehensive genomic profiling (CGP). To determine the nature and degree of toxicity of~     pembrolizumab as assessed by CTCAE in patients with persistent, recurrent or metastatic~     endometrial carcinoma. Secondary Objective(s): To estimate the duration of progression-free~     survival (PFS) and overall survival (OS).~   "
12015|NCT02899897|"~     IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of~     septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40%~     and up to 65% of the population concerned. However, the capacity of the various indices to~     predict the response to IV fluid therapy in septic shock with left ventricular systolic~     dysfunction have not been clearly defined. Measurement of parameters reflecting filling~     pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate~     cardiac function and estimate the filling reserve, but with no strong evidence. Right heart~     catheterization with determination of cardiac output by pulmonary thermodilution can also be~     used to measure the various parameters commonly used to predict the response to IV fluid~     therapy. Very few data are available with no reliable and clinically relevant data in this~     population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the~     response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary~     thermodilution and right heart catheterization. Consequently, the capacity of the various~     indices of preload dependence to predict the response to IV fluid therapy in septic shock~     with left ventricular systolic dysfunction remains difficult to define.~   "
12016|NCT02899884|"~     The purpose of this study is to determine the prevalence of breakthrough cancer pain and~     characterize breakthrough cancer pain in an unselected, representative cohort of cancer~     outpatients with or without pain who attend consultations.~   "
12017|NCT02899871|"~     IBD (inflammatory bowel disease) are associated with various types of joint manifestations,~     especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint~     symptoms, with variable expressions and aetiologies, possibly responsible for impaired~     quality of life, and possibly leading to discontinuation of an effective and validated~     treatment.~   "
12018|NCT02899858|"~     Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to~     stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20~     years, clinicians have tried to reengage such these circuits for standing and walking in the~     lower spinal cord of paralyzed humans through novel paradigms of physical therapy,~     pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the~     spinal cord. Although standing and stepping with these maneuvers are rudimentary at best,~     these human studies offer promise to restore controlled, lower extremity movement to the~     spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal~     activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce~     more fatigue resistant, natural standing and stepping activity in humans. To date, there has~     been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have~     been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel~     intraspinal neuroprosthetic that should be able to restore control of standing or walking in~     a manner that is much more physiologically normal and tolerable than by stimulating each~     individual muscle group. Proof of the existence of these spinal circuits in man, and the~     ability to activate and control these circuits by first mapping the spinal cord is the basis~     of this proposal.~   "
12019|NCT02899845|"~     This project aims to study the effect of haptic sensory information delivered at the hand~     using a cane in light touch or light support condition on postural stability and spatial~     and temporal gait parameters of elderly subjects with and without walking difficulties~   "
12020|NCT02899832|"~     This study will included 20 children presenting with epilepsy with spasms. It aims to offer~     these children, non invasively and without supplementary examinations, a recording of local~     and cerebral hemodynamic changes concomitant with an electroencephalographic recording~     during epileptic episodes. This will be carried out by combining optical imaging using near~     infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous~     high-resolution (HR) recording.~      This study is among those based on multimodal analyses of epilepsy, combining methods of~     analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).~      Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal~     dysfunction from a functional point view. It is used in the routine follow-up of children~     with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in~     the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid,~     non invasive, and inoffensive which could easily be used at the child's bedside or in a~     clinical setting and can provide metabolic information about cerebral function.~      This study is multidisciplinary, which calls upon the skills of neurophysiologists,~     biophysicists, and clinicians~   "
12021|NCT02899819|"~     The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie~     region to commonly used pesticides. These pesticides were selected in a pilot study (the~     Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine~     perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators~     of pesticide use and the presence of pesticide in the environment in Picardie.~      These substances (or their metabolites) will be measured in the each newborn's meconium (the~     first faeces after birth) and each newborn's mother's hair in the Picardie region during the~     study period. The mother's exposure will also be assessed using a retrospective~     questionnaire (filled out within a few days of the delivery).~      Thus, the MecoExpo project will enable the investigators to:~        1. evaluate the relationships between foetal exposure (via the meconium), maternal~          exposure (via the hair and the questionnaire) and clinical parameters measured at birth~          (term, length, weight, etc.).~        2. map pesticide exposure across the Picardie region.~        3. create a meconium bank in Picardie (the first ever meconium bank in France).~   "
12022|NCT02899806|"~     The aim of this study was to investigate the impact of multimedia information on epidural~     anesthesia. Pregnant women were randomly assessed to get a video information in addition to~     an oral and written information on epidural anesthesia. Maternal satisfaction concerning the~     quality of the information as well their anxiety and understanding of the procedure were~     assessed and compared in both groups.~   "
12024|NCT02899780|"~     This study is a first-in-man clinical trial using fiber optically delivered ultraviolet~     light for reducing viable bacteria within indwelling tunneled dialysis catheters.~   "
12367|NCT02895451|"~     The purpose of this study is to investigate the effects of an extended behavioral~     intervention in exercise-based CR for improvement of physical capacity, adherence,~     psychological and physiological parameters, compared with usual care.~   "
12025|NCT02899767|"~     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an~     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,~     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive~     induction plus more potent intensification programs with chemotherapy alone or chemotherapy~     plus stem cell transplantation (SCT) has improved treatment results. Advances in~     understanding disease biology, improvements in induction and consolidation program, and~     better supportive care have also all contributed. A number of clinical and laboratory~     characteristics influence the response to treatment and, thus, the survival of patients with~     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.~     However, other factors may have a prognostic value and may influence patient's outcome.~      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it~     has become apparent that the frequency of allogeneic blood transfusions can modify host~     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic~     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood~     cell (RBC) transfusion need was identified as a strong and independent risk factor for~     survival in MDS, for which the presence and severity of anaemia were attributed to a~     clonally advanced and biologically more aggressive disease.~      Based on these data, we retrospectively assessed the prognostic value of RBC and platelet~     transfusions at the time of diagnosis and the frequency of transfusions during the first~     induction course of chemotherapy in a large unselected group of patients with previously~     untreated AML.~   "
12026|NCT02899754|"~     Veterans have a high risk of developing lung in comparison to general populations due to~     their older age and smoking history. Recent evidence indicates that lung cancer screening~     with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the~     rates of false positive findings are high, requiring further testing and evaluation.~     Preliminary studies report that while some Veterans are enthusiastic about screening, others~     are highly reluctant. Patient preferences should be considered as part of an informed~     decision making process for this emerging paradigm of lung cancer control. Effective methods~     for preference assessment among Veterans have not yet been developed, evaluated, and~     integrated into clinical practice. The specific aims of this study are to 1) elicit patient~     and provider stakeholder input to inform the development of a lung cancer screening decision~     tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that~     incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool~     compared to usual care on the decision process, clinical outcomes, and quality of life.~   "
12027|NCT02899741|"~     The purpose of this study is to determine whether omega-3 is effective in the treatment of~     medically intractable epilepsy as adjunctive therapy.~   "
12028|NCT02899728|"~     This randomized phase II trial studies how well olaparib, cediranib maleate, and standard~     chemotherapy work in treating patients with small cell lung cancer. Drugs used in~     chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate,~     and standard chemotherapy may work better in treating patients with small cell lung cancer.~   "
12029|NCT02899715|"~     This phase I trial studies the side effects and best dose of panobinostat in treating~     younger patients with diffuse intrinsic pontine glioma that is growing, spreading, or~     getting worse (progressive). Panobinostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
12030|NCT02899702|"~     IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at~     assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment~     in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.~   "
12031|NCT02899689|"~     Women undergoing mechanical cervical ripening for labor induction will be randomized to~     Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators~     (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.~   "
12032|NCT02899676|"~     The aim of this study was to identify neural correlates involved in arthmetics processing in~     adults and children aged 8 to 14 with normal cognitive function. Brain area will be~     identified by functional magnetic resonance imaging (IRMf).~   "
12033|NCT02899663|"~     Systematic retrospective medical chart and medical imaging file review of all patients~     receiving brain MRI for the follow-up of glioblastoma.~   "
12034|NCT02899650|"~     The purpose of this study to determine if older adults who are healthy and physically active~     (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous~     exercise of downhill running than younger peers.~   "
12035|NCT02899637|"~     The main objective is to conduct a study protocol to investigate the effects of repetitive~     Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals~     with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial~     of patients with iSCI will be conducted.~   "
12036|NCT02899624|"~     Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined~     by the presence of two sigmoid valves instead of three. It is conventionally associated with~     histological abnormalities of the wall of the ascending aorta, risk factors of aortic~     dystrophy observed in 50% of cases, and dissection. Long considered an accident of~     development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and~     aortic dystrophy suggests the existence of a genetic predisposition and a common genetic~     origin for these two pathologies.~      Data on the genetic basis of the BAV are still limited, but the existence of a large~     phenotypic diversity suggests the involvement of other genes. The establishment of large~     collections of DNA will allow great advances in this field.~      The purpose of this project is to confirm the existence of a genetic determinism at the~     origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying~     genetic defects associated with the presence of a BAV in a series of candidate genes.~   "
12744|NCT02890420|"~     This study permit to evaluate the characteristics of children in third year of preschool,~     during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual~     medical visit.The aim of the study is to describe the nutritional status of children~     under-six years of age: underweight, overweight, and obesity considering the sex. .~   "
12038|NCT02899598|"~     Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization~     against fetal platelet antigens with paternal origin not present in the mother. It is~     considered the equivalent of hemolytic disease of the newborn. The incidence of this disease~     is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or~     cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can~     cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic~     diagnosis requires the detection of anti-platelet antibodies with maternal determination of~     platelet phenotypes and genotypes of the two parents.~      The objective of this work is to develop specific molecular tools to fetal platelet~     genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 ,~     HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these~     results with those obtained from an invasive sampling of amniotic fluid.~      This is a prospective study to assess the technical and diagnostic performance of a new~     molecular method noninvasive prenatal diagnosis of platelet genotyping.~   "
12039|NCT02899585|"~     The aim of the research is to detect prematurely vulnerable patients needing a global~     coverage in integrated care with a created and metrological validated score.~   "
12040|NCT02899572|"~     Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients.~     The important frequency of these disorders and their consequences in term of quality of life~     have a strong contrast with the actual interest showed for them by the medical community.~      Natural evolution of the disease and its management make that these disorders often occur~     little time after a therapeutic change. As a consequence, patients often accuse their~     medication to be responsible for the appearance of these disorders. This confusion,~     associated to false believes that may have the patients on their disease or their treatment,~     often leads to treatment discontinuation which has a deleterious effect on the disease~     evolution.~      Educational therapy programs showed a positive impact on therapeutic adherence. Increasing~     patients' knowledge on their disease and treatments increases their therapeutic adherence~     and makes it easier to balance diabetes and therefore limits complications appearance.~      Educational therapy programs concern today the disease, its process, its evolution, its~     treatments, their efficacy, their adverse effects but erection disorders are not~     specifically addressed.~      This study aims to evaluate the impact of a sexology consultation on diabetes balance~     measured via HbA1c rate. This consultation aims at precising this particular symptom of~     erection disorders, without any medicine prescription. The aim is to explain to patients the~     different links between their symptoms, diabetes, medicines and themselves.~   "
12041|NCT02899559|"~     This primary object of this study is to test to the hypothesis that the both the nudge and~     boost messages will increase short term gym utilization relative to the control condition~     but that only the boost message will increase long-term gym utilization.~      Non-technical summary: College students will receive one of three messages about exercise.~     Their card swipe data as a measure of gym utilization will be tracked as an assessment of~     the effect of those messages.~   "
12042|NCT02899546|"~     Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter~     (PICC)-related infections among patients managed in the University Hospital of La Reunion~     for PICC setting.~   "
12043|NCT02899533|"~     In this study positron emission tomography (PET/CT) imaging will be used to evaluate~     evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial~     Hypertension (PAH) using the investigational radiotracer [18F]fluoroestradiol (FES).~   "
12044|NCT02899520|"~     The objective of this study is to compare two methods of pelvic floor muscle training:~     reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and~     Control of Perineum)~   "
12045|NCT02899507|"~     The purpose of this study is to determine whether there is potential benefits of~     prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest~     (OHCA) treated in intensive care unit with therapeutic hypothermia.~   "
12046|NCT02899494|"~     To emit voluntarily sounds mastered during the childbirth is a practice found in certain~     cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical~     coverage and because of the childbirth in a hospital environment, this tradition is not~     anymore transmitted.~      The emission of a sound vibration conjugated to a positive intention managed during the~     childbirth was experimented with around thirty mothers. In the term of this pilot study,~     most of the women expressed one felt very positive towards the new method, in particular~     when they compared it with a previous childbirth where this method was not used.~      During these childbirths, the midwives also indicated a shortening of the working time.~      The present study aim essentially is to confirm the positive effect of the method on the~     felt of the childbirth.~   "
12047|NCT02899481|"~     Investigators will perform a randomized controlled trial comparing the effect of~     transabdominal and transperineal ultrasound in pregnant women in the second stage of labor,~     in whom it was decided an operative delivery. Our objective is to evaluate the impact of~     intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy~     of an instrumental delivery.~   "
12048|NCT02899468|"~     The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual~     reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with~     traumatic brain injury (TBI). These patients, service members with TBI, can be both with and~     without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to~     improve cognitive and motor function, as well as mood.~   "
12049|NCT02899455|"~     A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and~     HGP0816 in Patients with Hypertension and Dyslipidemia~   "
12068|NCT02899208|"~     This study aims to investigate whether an actigraph, measuring in-hospital activity, used~     for a week after discharge from the ICU at Zealand University Hospital Køge, can predict~     physical function at three-month follow up.~      The hospital activity will be measured with actigraphy, a measurement tool that quantifies~     activity level. The activity will be measured for 7 days after ICU discharge. The actigraph~     is to be worn as a bracelet.~      The physical function will be measured with Chelsea Critical Care Physical Assessment Tool~     (CPAx). CPAx is assessed at ICU discharge and after three months.~   "
17177|NCT02832492|"~     In this study researchers will test pupil near response(PNR)in patients in unresponsive~     wakefulness syndrome(UWS)and compare the favourable prognostic difference between patients~     with PNR and patients without PNR.~   "
12050|NCT02899442|"~     With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious~     economic and social reasons, the consequences of night work on cardiovascular risks are~     substantial. Compared to day workers, it was reported higher risks of cardiovascular~     diseases (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The~     occurrence of metabolic syndrome increases the risk to develop high blood pressure, diabetes~     and cardiovascular events. Because some characteristics of night work are potentially~     modifiable, some preventive strategies could be applied to reduce its adverse effects. For~     shift workers, some recent guidelines (High Health Authority, 2012 & 2016) and fruitful~     literature propose to develop regular assessments of cardiovascular risk factors and~     occupational activities, and stress the need to expand preventive strategies. Moreover, some~     recent French laws provide an opportunity to implement preventive interventions and specific~     monitoring through the occupational physicians network. However, whether the concept is~     defined, the exact content, method and the potential benefits are unknown. The investigator~     assume that individual advice related to collective countermeasures referenced on guidelines~     (applied on worksite within plant) could lead a better improvement on incidence of metabolic~     syndrome compared to those that benefit only individual advice.~      Main objective:~      To measure the benefit from implementation of individual and collective prevention~     (dispensed in worksites within plants) on metabolic syndrome compared to strategy relying~     only on individual prevention among night workers, over 2 years' follow-up. The secondary~     objectives of the study are to evaluate in both groups:~        1. Observance of different types of preventive strategies~        2. Impact of observance of preventive advice on metabolic syndrome in shift workers and on~          each component of metabolic syndrome~        3. Determinants which promote the up-take of preventive strategies among night workers~        4. The countermeasures which could be applied and effective within company 5)~          Medico-economic assessment is planned from an ancillary study.~   "
12051|NCT02899429|"~     Systematic study of the ultrasound infringements of tendons chest expanders of entheses the~     most involved in spondylarthropathies and small joints of hands and feet in expanding~     patients of psoriasis to estimate if there is an infra-clinical infringement of the~     psoriasic rheumatism .~   "
12052|NCT02899416|"~     BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a~     cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from~     12.5 to 17.5 years old through 10 Europeans towns from 9 countries.~      BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants~     of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle~     risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors~     and risk population cluster.~   "
12053|NCT02899403|"~     In the perspective to better evaluate the efficacy of new treatment strategies for Alzheimer~     disease (AD), it appears important to develop experimental paradigms to precisely measure~     cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate~     drug efficacy profile.~      The use of Electroencephalography (EEG) may be, therefore, a good candidate. The purpose of~     the present study is to use EEG to more precisely explore cognitive processes in healthy~     subjects, with a particular interest in episodic and working memory functions that are~     usually altered in both AD and Mild Cognitive Impairment (MCI) as well as to better~     understand underlying neural mechanisms involved in these processes.~   "
12054|NCT02899390|"~     Diabetes is a major non communicable chronic diseases in the world. It occupies the fourth~     or fifth leading cause of death in most high-income countries and there is strong evidence~     that has epidemic proportions in many developing countries, including Mexico. Like diabetes,~     prediabetes is associated with obesity and insulin resistance, thus promoting a lifestyle~     with healthy eating and physical activity can reduce weight and in turn the risk of~     diabetes.~      Several studies have shown that it is possible to prevent or delay the development of type 2~     diabetes through a lifestyle intervention based on diet and physical activity. The National~     Diabetes Prevention Program is a study based on the Diabetes Prevention Program conducted in~     real-world conditions.~      It is known that the acculturation of some ethnic groups has led to the increase in certain~     chronic degenerative diseases due to increased associated risk factors. The rural Yaqui~     tribe has a high prevalence of overweight, obesity, high triglycerides and type 2 diabetes.~     In addition to the rural Yaqui tribe there is another settlement of this tribe in the city~     of Hermosillo Sonora. Information on the health of this ethnic group is limited, however, it~     is known that being seated in an urban setting with an obesogenic lifestyle, which has been~     shown to have serious health effects in other populations, suggesting a high prevalence~     chronic non-communicable diseases such as obesity, type 2 diabetes and hypertension at this~     ethnic group.~      The present study is a translational research clinical trial to evaluate the effectiveness~     of the National Diabetes Prevention Program to improve obesity parameters (weight, BMI,~     waist circumference) and increase physical activity in adults who are at risk of diabetes in~     the Yaqui tribe established in Hermosillo, Sonora.~   "
12055|NCT02899377|"~     This is a pilot imaging study to determine whether molecular imaging with 18^F~     fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT),~     11^C-Methionine (MET) PET/CT, and salivary gland magnetic resonance imaging (MRI) with~     Dotarem (gadoterate meglumine) have the potential to characterize and quantify disease~     manifestations in primary Sjögren's syndrome (pSS) subjects. This will be achieved by~     assessing the associations and consistency between the imaging techniques studied, clinical~     assessments (salivary and tear flow and clinical scores), laboratory biomarkers, and~     histological findings on minor salivary gland biopsy.~      In this study, healthy volunteers will be enrolled in Group A and pSS subjects in Group B.~     The subjects will be required to undergo screening and baseline assessments including~     unstimulated and stimulated salivary flow and Schirmer's test; an imaging visit (Visit 1); a~     sample collection visit (Visit 2) for repeat of selected baseline assessments and a minor~     salivary gland biopsy for pSS subjects only; and a follow-up visit. The total duration of~     participation in the study will be up to 11 weeks.~   "
12069|NCT02899195|"~     Patients with pleural mesothelioma that can not be surgically removed will receive~     durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as~     first-line treatment.~      Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory~     tests show that it works by allowing the immune system to detect your cancer and reactivates~     the immune response. This may help to slow down the growth of cancer or may cause cancer~     cells to die.~      The purpose of this study is to see whether adding durvalumab to standard chemotherapy will~     improve overall survival (OS).~   "
12091|NCT02898909|"~     Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed~     by ultrasound phacoemulsification of nuclear lens, which is then removed.~      It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the~     post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of~     ultrasonic energy.~      The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the~     patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal~     transparency.~   "
12056|NCT02899364|"~     Rationale: the cornerstone treatment of a heart attack is a procedure called primary~     percutaneous coronary intervention (PPCI): the cardiologist uses a catheter and guides it~     through an artery, mostly the wrist artery, to the site of the narrowing in the coronary~     artery in the heart and opens it with a balloon. Thereafter a small metal tube is placed at~     the site of the narrowing to keep the artery open). However, a heart attack still leads to~     irreversible injury to the heart with a risk of heart failure. The investigators have~     evidence from (cell/animal) that administration of hydrogen sulfide (H2S), which is also~     made in the human body, has been shown to protect the heart muscle and organs from damage~     caused by the lack of oxygen resulting from a heart attack. Data in humans suggests that~     sodium thiosulfate (STS) (a medicine that releases H2S in the body, and is already used to~     treat other diseases, i.e. cyanide poisoning and renal failure associated diseases) can be~     administered safely.~      Objective: to evaluate if sodium thiosulfate protects the heart from damage caused by a~     heart attack.~      Study design: a single centre, double blind (both doctor and patient do not know which~     treatment patient gets), randomized controlled clinical trial.~      A total of 380 patients, aged 18 years and above, undergoing treatment for a first heart~     attack are divided in two groups (decided by chance): 1 group receives sodium thiosulfate,~     the other receives a fake medicine (salt water that looks exactly like sodium thiosulfate).~      After 4 months patients receive a magnetic scan of the heart to evaluate the permanent~     damage of the heart muscle. When comparing the patients from both groups to each other the~     investigators can say something about the effectivity sodium thiosulfate.~   "
12057|NCT02899351|"~     In this research study, the investigators want to learn more about whether the Respiratory~     Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of~     age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to~     measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the~     number of times per minute a breath is taken (Respiratory Rate), and the amount of air going~     in and out of the lungs per minute (Minute Ventilation).~      It is important for medical staff to be able to collect information about breathing~     non-invasively because it may help determine if certain children are experiencing breathing~     problems sooner than the way it is currently detected.~      The goal of this study is to determine if the Respiratory Volume Monitor works accurately in~     infants less than 12 months of age.~   "
12058|NCT02899338|"~     To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after~     single injection using either auto injector or prefilled syringe.~   "
12059|NCT02899325|"~     Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed~     early the disease is treatable with surgery. Current conventional imaging modalities have~     limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans~     to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver~     cancer) using these PET/CT scans.~   "
12060|NCT02899312|"~     Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients~     with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients~     will have their PC return. Whether it has returned locally or distantly determines which~     type of treatment they will receive. Current conventional imaging modalities have~     limitations particularly at low PSA levels. This study proposes to use 18F-DCFPyL PET/CT~     scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body~     the PC has recurred.~   "
12061|NCT02899299|"~     The purpose of this study is to test the effectiveness and tolerability of the combination~     of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients~     with unresectable pleural mesothelioma.~   "
12062|NCT02899286|"~     To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute~     myeloid leukemia (AML) in terms of remission rate.~   "
12063|NCT02899273|"~     In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Preceding~     results of eye-tracking-studies on the perception of patients with unilateral cleft and~     patients with severe orthognathic malocclusion let us assume that caries and missing teeth~     might influence the observer's focus. The aim of this study is to test the hypothesis that~     the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.)~     are contemplated differently from and assessed more negatively than healthy patients.~     Particular attention should be paid to potential differences between the findings of the two~     observer-groups (medical laypersons/ dental students).~   "
12064|NCT02899260|"~     This study is designed as a prospective, randomized controlled trial that will compare the~     use of the peanut exercise ball in laboring patients compared with no use of the exercise~     ball. We hypothesize that use of the peanut ball decreases the incidence of cesarean~     section.~   "
12065|NCT02899247|"~     This trial, based on a split mouth and double-blind design, will evaluate the effects of a~     surface sealant on the clinical performance of composite resin class I restorations.~     According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be~     restored with Esthet X composite resin. For each pair, one surface will be sealed with~     Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced~     operators using modified USPHS (United States Public Health service) after 5 years after~     treatment. Data will be analyzed using the McNemar test (p < 0.05).~   "
12066|NCT02899234|"~     According to the World Health Organization cigarette smoking is today one of the leading~     single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has~     been marketed as a safer alternative to conventional cigarettes, and its global sales~     continue to grow exponentially each year. Despite growing e-cigarette use, scientific data~     on health effects are insufficient in some respects and completely lacking in others.~     Therefore the current study is designed to investigate the effects of active e-cigarette~     inhalation on the cardiovascular and respiratory systems.~   "
12067|NCT02899221|"~     This phase I trial studies the side effects and best way to give hyperthermia and high dose~     rate radiation therapy in treating patients with prostate cancer that has come back after~     prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses~     radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia~     therapy may make tumor cells more sensitive to the effects of radiation therapy by heating~     them to several degrees above normal body temperature. Giving hyperthermia and high dose~     rate radiation therapy may work better in treating patients with recurrent prostate cancer~     after radiation.~   "
12070|NCT02899182|"~     Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard~     diagnostic tool for prostate cancer and, though may be well tolerated for some patients,~     about 65 to 90% of then still complain of discomfort, weather associated or not to pain.~     Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction~     between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%,~     as a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation,~     without the need for an anesthesiologist.~      Materials and methods: A randomized clinical trial, simple blind, which took place in~     Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients~     each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which~     received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They~     were accessed for pain with VAS, answered a satisfaction task and were recorded about~     collateral side effects.~   "
12071|NCT02899169|"~     The investigators design a multicenter randomized controlled trial to prove that RIF plus~     ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for~     the patients with non-high-risk APL.~   "
12072|NCT02899156|"~     Delirium within the intensive care unit (ICU) is associated with poor outcomes such as~     increased mortality, ICU and hospital length of stay (LOS), and time on mechanical~     ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of~     delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing~     duration of delirium and subsequent complications.~      This is a single-center randomized, double-blind, placebo-controlled study of critically ill~     adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that~     flumazenil continuous infusion reverses hypoactive delirium associated with BZD toxicity and~     thereby reduces duration of delirium and ICU LOS.~   "
12073|NCT02899143|"~     The purpose of this study is to compare the effect of a short course antimicrobial therapy~     (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.~   "
12074|NCT02899130|"~     This trial will study the effect of a polyherbal capsule in lowering the viral load of~     patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B~     surface antigen elimination in 12 months~   "
12075|NCT02899117|"~     The proposed project will examine feasibility and preliminary efficacy of a yoga~     intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC)~     and includes two parts: (1) a survey of children and parents regarding preferences (e.g.,~     convenient days/times), experiences and expectations regarding yoga (including barriers and~     positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10~     pairs of children and parents.~   "
12076|NCT02899104|"~     Categorize the clinical parameters and patient determinants that drive physician decision~     making for treatment selection including Radium-223 for patients with mCRPC.~   "
12077|NCT02899091|"~     The objective of the study is to evaluate the safety and the potential therapeutic effects~     of CB-AC-02 Intravenous Transplantation in patients with Alzheimer' disease comprised of 2~     treatment cohorts:~   "
12078|NCT02899078|"~     This phase Ib/II trial studies how well ibrutinib and nivolumab work in treating patients~     with previously-treated kidney cancer that has spread to other parts of the body. Ibrutinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread. Giving Ibrutinib and nivolumab may work better in treating patients with~     metastatic kidney cancer.~   "
12079|NCT02899065|"~     This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate~     (in aggregate) both the use of the Cepheid GeneXpert Flu/RSV Assay and the use of~     pharmacist-led education for providers in the interpretation of these test results.~   "
12080|NCT02899052|"~     A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of~     venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed~     or refractory MM and have received 1 to 3 prior lines of therapy.~   "
12081|NCT02899039|"~     IgG4-related disease is a rare and very recently identified pathology, whose frequency is~     certainly underestimated.~      The clinical presentation varies among affected organs, and most often, patients have at~     least three organ damage.~      These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe~     fibrosis progression resulting in a loss of function.~      The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological~     marker, currently held by several teams, is the presence within the inflammatory infiltrate,~     of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG~     +> 50% on tissue immunostaining.~      The investigators project provides a global assessment of T lymphocyte abnormalities and~     specifically the TFH (Follicular Helper) during this IgG4-related disease compared to~     so-called groups control subjects suffering from Sjogren syndrome or healthy subjects.~   "
12082|NCT02899026|"~     Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine~     with high affinity that may have therapeutic benefit in the treatment of polymyalgia~     rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits~     IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation,~     resulting in the inhibition of the biological effect of IL-6. This study will evaluate the~     efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in~     the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and~     consists of the following phases: Screening phase, Part A: 52-week double-blind treatment~     phase, Part B: 52-week extension phase with no study drug administration and a 16-week~     follow-up phase if applicable.~      Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of~     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to~     receive one of two doses of sirukumab or placebo, each in addition to a pre-specified~     prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be~     assessed at Week 52. Subjects completing Part A of the study who are in clinical remission~     will be eligible to enter Part B, the 52-week extension phase, designed to investigate the~     long-term maintenance of remission and safety following cessation of sirukumab treatment and~     to assess long-term corticosteroid use. Subjects will need to have follow-up safety~     evaluations for at least 16 weeks after receiving the last dose of study drug, applicable~     for those who have withdrawn prematurely from the study or who have completed Part A but are~     not eligible for Part B.~   "
12083|NCT02899013|"~     The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six~     years after the first cases of luminal disease. If phenotypic data of the latter are well~     documented today, those of perianal disease remain inadequately described. The reasons are~     numerous: understated symptoms by patients, elementary semiotics proctology ignored by~     practitioners, lack of validated classifications to track these violations and challenges to~     undertake clinical trials to high standard of proof in view of these variables, etc. ...~     Moreover, the impact of these LAP varies across studies (10-80%). in addition to the~     above-mentioned reasons, these results are also due to the different definitions of LAP used~     in the studies, their collection in reference centers versus tertiary centers, their~     potential occurrence at any time of disease progression, their greater frequency in case of~     distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case~     of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should~     be better documented because they are a factor of poor prognosis of Crohn's disease.~   "
12084|NCT02899000|"~     Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel +~     oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer~     nodules or cysts (non-nodulocystic) during a 12-week treatment period.~   "
12085|NCT02898987|"~     The objective of the Dataids cohort is to continue a long-term, prospective collection of~     clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking~     care in 15 HIV centers in France in order :~        1. to provide and develop a surveillance system to describe clinical practice and temporal~          changes in the clinical course of HIV and HIV-related co-infections and co-morbidities~          in France.~        2. to assess the factors associated with the clinical, immunological and virological~          course of HIV infection and HIV-related co-infections and co-morbidities~      The specific objectives are as follows~        -  To continue surveillance of HIV infection in France to describe temporal changes~        -  To evaluate the efficacy of ART and factors associated with ART efficacy~        -  To monitor the uptake and outcome of HCV therapy~   "
12086|NCT02898974|"~     Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom,~     e.g. spasticity and pain, management. Unfortunately not much is known about its effects~     outside the treatment for these 2 symptoms. Several previous studies have suggested people~     with MS using medical marijuana have lower levels of physical disability and improved~     walking abilities. A major limitation of these previous studies is that the investigators~     used subjective measures of motor function. In this proposed observational case-control~     study the investigators plan to objectively measure multiple domains of motor function, such~     as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or~     given to participants.~   "
12087|NCT02898961|"~     Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in~     ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg~     gentamicin achieved target concentrations in ICU patients with severe sepsis.~   "
12088|NCT02898948|"~     Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is~     normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1~     for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes~     for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is~     repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells.~     Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into~     calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a~     neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other~     cytokines.~      PCT is used in critical care departments as a diagnostic marker, a guide to treatment~     (antibiotics are withdrawn if the level falls) and a prognostic marker.~      There are few data on the diagnostic use of PCT in an internal medicine department. The~     available studies yielded contradictory results and only one prospective study has been~     performed . The objective was to study PCT in non-infectious, inflammatory pathologies and~     to establish whether PCT could distinguish infections from other inflammatory pathologies in~     patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of~     0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have~     been performed but featured small sample sizes and a retrospective design.~      Of the various studies performed in internal medicine departments, none included patients~     presenting with a suspected bacterial infection (according to the clinician's~     interpretation) and lacking information on their bacterial status. In fact, these diagnoses~     are a core component of hospitalisation in internal medicine departments for fever or~     inflammatory syndrome. The investigators intend to include all patients, including those~     lacking information on their microbiological status).~   "
12089|NCT02898935|"~     Reconstruction software allows visualization of cortical structure in 3 dimensions, showing~     on a single picture the position of all the electrodes. The EEG signal of each recording~     plot of the electrode is analyzed and compared with the underlying brain structure~     reconstructed by the software. It is therefore possible to visualize 1) ictogenic and~     epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2)~     adjacent functional cortical areas with functional imaging and SEEG. Software makes it~     possible to determine the links between these areas. This study aims to show that using~     these software is an asset in surgical decision and in the choice of surgical strategy.~      Each patient has presurgical evaluation (usual care), including morphologic and (if~     necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the~     processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist.~     The surgical decision will be taken according to the usual staff procedures, based on the~     usual examination results. After the decision making process, the staff will be asked to~     reconsider the surgical decision, according to the analysis provided by the software. The~     discrepancies between the decisions will be recorded.~   "
12090|NCT02898922|"~     Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV)~     can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular~     carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection.~     Whether patients with HCV infection have non-protective antibody responses to hepatitis B~     vaccination more frequently than healthy subjects is still controversial and studies about~     cytokine response have been seldom reported.~      Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender~     matched healthy control were obtained from a community-based screening. All participants~     received three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months~     schedule. Anti-HBs was tested 1 month after the third dose of vaccination and was compared~     between two groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2),~     interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte~     were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.~   "
12093|NCT02898883|"~     The investigators study seeks to evaluate the feasibility and efficacy of a parent-focused,~     early intervention to prevent the development of chronic PTSD for children admitted to the~     emergency department for an acute traumatic injury and their parents. Furthermore, the~     investigators will identify potential risk factors for the development of PTSD and factors~     that influence treatment response. Finally, the investigators will prospectively measure~     trajectories of parental and child responses to trauma and their interaction over time. This~     study will bring together a multidisciplinary team across two major research universities~     (Case Western Reserve University and Kent State University) and a large pediatric trauma~     center (Akron Children's Hospital) in an effort to reduce rates of PTSD in children~     following traumatic injury.~   "
12094|NCT02898870|"~     The link between the products of synthetic chemistry and cancer is at the heart of much~     research. Recent work has identified the use of plant protection agents by farmers as a risk~     factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL)~     is the most common histology. Different biological models were used to understand the role~     of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and~     molecular level, on different signaling pathways. After metabolized by cytochrome P450,~     these compounds generally become pro-oxidants. The increase in reactive oxygen species rate~     (SAR) causes the activation of signaling pathways involved in cell proliferation and~     survival. But deregulation of oxidative status does not in itself justify the specificity of~     the impact of pesticides on specific pathologies. Several agents have a genotoxic effect,~     others induce the activation of signaling pathways by binding to transcription factors and~     others have immunomodulating properties.~   "
12095|NCT02898857|"~     Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this~     disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell~     lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including~     chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or~     induction chemotherapy). The reason of this combined modality treatment is the really poor~     prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when~     the lymph node under the carina is affected). Up till now, the five-year survival of~     patients who underwent surgical resection of N2 NSCLC does not exceed 15%~   "
12096|NCT02898844|"~     This study examined how dieting with a partner affects weight loss, diet adherence,~     psychological well-being, and cortisol.~   "
12097|NCT02898831|"~     This study will be a prospective randomized controlled trial comparing cold compression to~     no intervention immediately prior to and during intrauterine device insertion. Subjects will~     be randomized to cold compress or no intervention (standard practice in our clinics).~     Following IUD insertion they will complete a validated pain scale survey regarding their~     pre-procedure and intra-procedure pain.~   "
12098|NCT02898818|"~     To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear~     will be studied.~   "
12099|NCT02898805|"~     The study is designed to compare the effects of two combination of nutraceuticals: Armolipid~     Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and~     Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week~     treatment with one of the combinations, according to a randomized scheme, on metabolic~     parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In~     particular, it will assess the ability of the two combinations to reduce the levels of total~     and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.~   "
12100|NCT02898792|"~     Obstructive Sleep Apnea (OSA) is the most common problem that affects sleep. People with~     this problem have their airway blocked or minimized, causing snoring or gasping while~     sleeping. It can also reduce the amount of oxygen that circulates in the blood of people~     affected by it. Millions of Americans have OSA; 10% of adults have diagnosed OSA, an~     estimated 25% have undiagnosed OSA. There is concern in the medical community about how to~     manage pain in patients with OSA because of the risk of decreased or slower breathing~     associated with certain pain medications called opioids. Giving OSA patients opioids could~     cause them to have even lower oxygen amounts in their blood stream. It is conceivable that~     patients with OSA may require lower doses of opioids to cause decreased breathing as~     compared to patients without OSA, however this has not been proven. In this study, we are~     using a very short acting and easily reversible opioid pain medication called remifentanil~     in patients with OSA in order to find out if treated and untreated OSA patients respond to~     opioid differently than patients without OSA.~   "
12101|NCT02898779|"~     To investigate the comparative tolerability, metabolism and pharmacokinetics of individual~     enantiomers of PQ in healthy human volunteers. The specific aim is the comparative~     evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of~     PQ (RPQ and SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.~   "
12102|NCT02898766|"~     This will be a randomized, cross-over design. Subjects will be randomized to one of two~     interventions on two separate study days, 1 week apart.~   "
12103|NCT02898753|"~     Phase I/II study enrolling up to 16 patients in a three-month, Randomized, Parallel Active~     Control, Single and Repeat Dose, Dose-escalation Study of the Safety, Tolerability,~     Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VAL-1221 Delivered~     Intravenously (IV) in Ambulatory and Ventilator-free Patients with Late-Onset GSD-II (Pompe~     Disease) Study~   "
12104|NCT02898740|"~     This project is investigating whether a home-based exercise program will reduce depression~     in patients with Parkinson's disease.~   "
12105|NCT02898727|"~     This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor~     Type 2 (HER2) positive breast cancers are able to be controlled by local therapies,~     Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain~     Radiotherapy (WBRT).~   "
12116|NCT02898584|"~     The purpose of this research study is to test the feasibility, acceptability, and~     preliminary effectiveness of the use of a mobile pharmacist-led intervention that~     incorporates home BP monitoring and medication reminders with patients recruited from a~     primary care setting, as well as identify challenges and potential solutions to broader~     implementation of a mobile pharmacist-led home-based BP monitoring intervention in primary~     care clinics through key stakeholder interviews.~   "
12106|NCT02898714|"~     On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be~     reimbursed in Belgium by means of a new diabetes reimbursement program for adults. For~     children, the Freestyle Libre FGM is also reimbursed by means of a new reimbursement program~     from the first of August 2016 onwards. Making this the only way to receive the device in~     Belgium. To understand the impact of this new FGM on diabetes patients in UZ Leuven and OLVZ~     Aalst, we want to study the use of the device by our patients by means of an observational~     study where patients complete questionnaires at regular time points in the first year of~     usage and after 24 months Clinical data will be gathered during the routine clinical visits~     as part of the reimbursement program.~   "
12107|NCT02898701|"~     This study contains two pilot studies: 1) one study will investigate practice dosage of a~     postural stepping task in healthy young individuals in order to determine an operational~     definition of performance plateau, and 2) the other study will investigate whether~     practicing beyond reaching a performance plateau improves learning of a postural stepping~     task in healthy older adults, compared to discontinuing practice immediately after reaching~     a performance plateau. The investigators hypothesize that the group that continues to~     practice beyond reaching their performance plateau will learn and retain the motor task~     better than the other group.~   "
12108|NCT02898688|"~     This study will address vaccine uptake both for pregnant women and for their children,~     through 20 months of age, to test the hypothesis that exposure to the P3+ intervention~     package will increase the likelihood a pregnant woman gets herself vaccinated against~     influenza and pertussis before delivery and get her child vaccinated on time. This study~     builds off of a prior intervention, developed by Emory, at the practice, provider, and~     patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to~     improve vaccination uptake among pregnant women, and later, their children.~   "
12109|NCT02898675|"~     Platelet rich fibrin is a second generation platelet concentration which contains various~     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy~     of PRF in subjects of chronic periodontitis in the operation of conventional periodontal~     flap.~   "
12110|NCT02898662|"~     Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark,~     Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized~     patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once~     weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA~     controller medication, which is then tapered down and withdrawn during a period of 3 weeks~     and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is~     used as reliever medication during the whole study period. Primary endpoint is Loss of~     asthma control. When the endpoint is met, patients will resume their ICS/LABA, will be~     followed for an additional 4 weeks and will thereafter discontinue the study.~   "
12111|NCT02898649|"~     Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal~     prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer~     patients is diagnosed in operable status. So, most of patients could not be treated with~     curative resection.~      Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable~     due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but~     have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without~     radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only~     less than 30% of patients showed treatment response, and median survival of LAPC patient was~     only 9 months. Thus, more effective treatment modality is needed for LAPC patients.~      Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but~     strong electrical fields to create permanent and hence lethal nanopores in the cell~     membrane, to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis~     and has tissue selectivity, so adjacent tissue or vascular structures can be preserved.~      Several clinical trials using IRE were performed to liver, kidney or lung cancer patients.~     We will operate IRE procedure to LAPC patients who were previously received standard therapy~     but showed no response, using NanoKnife IRE device. We will investigate treatment response~     and safety of IRE.~   "
12112|NCT02898636|"~     Identify the cytokine or combination of cytokines, with the best diagnostic performance to~     characterize the vital nature of a skin wound in the body.~   "
12113|NCT02898623|"~     TB remains a health problem in France with about 5,000 new cases per year. Development of~     new screening tests is a priority for TB. The main objective of the study is to evaluate~     performances of innovative blood tests to identify active tuberculosis in adults patients~     living in low-prevalence country. Adult patients with possible TB from will be tested for~     the presence of antibodies directed against M. tuberculosis selected antigens. Positive and~     negative predictive values will be established based on TB culture results.~   "
12114|NCT02898610|"~     This study evaluates the use of Colchicine in adults over 40 years of age who have suffered~     an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other~     defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or~     to usual care alone.~      To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as~     antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice)~     compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial~     infarction, cardiac arrest, hospitalization for unstable angina and vascular death after~     ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other~     defined causes unrelated to atherosclerosis~   "
12115|NCT02898597|"~     As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as~     cardiovascular diseases and cancers on these people have consistently increased. Smoking is~     one of the major contributing factors to these health problems and rates of cigarette~     smoking in this group are substantially higher than those of the general population: 40-70%~     vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the~     negative consequence of smoking than their male counterparts. They are also less likely to~     see tobacco dependence treatment for dual stigma associated with both conditions: HIV~     infection and nicotine addiction. This is a pilot study to develop smoking cessation~     intervention for these women.~   "
12134|NCT02898350|"~     Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and~     efficacy of combined treatment for minimizing of surgical scars, including post Moh's~     surgery.~   "
12135|NCT02898337|"~     Torsades de pointes (TdP) is a polymorphic ventricular tachycardia associated with~     prolongation of the heart rate-corrected QT (QTc) interval on the electrocardiogram (ECG).~     TdP can result in catastrophic outcomes, including sudden cardiac death. QTc interval~     prolongation is a well-known adverse event associated with methadone use. While some risk~     factors for methadone-associated QTc interval prolongation and TdP have been identified, the~     contribution of interacting drugs and concomitant administration of other QTc~     interval-prolonging agents to overall risk has not been determined. The effect of ECG~     screening and monitoring on clinical outcomes in patients taking methadone has not been~     evaluated, and clinical opinion regarding routine ECG and risk factor monitoring varies.~     Twelve lead ECGs are costly and time-intensive for clinic staff. ECG screening in selected~     patients based on presence of QTc interval risk factors, rather than broadly in all patients~     taking methadone, would facilitate more targeted, strategic QTc interval monitoring. The~     FDA-approved AliveCor® handheld smart phone/tablet device records a single lead ECG (iECG)~     within 30 seconds. Use of this device may facilitate simpler, more rapid and less costly ECG~     monitoring in patients receiving care in narcotic treatment centers.~      Our long-term goals are to determine mechanisms by which drugs cause arrhythmias, to~     identify patients at greatest risk of drug-induced arrhythmias, and to determine safe and~     effective methods for prevention and management of drug-induced arrhythmias.~      Specific Aim 1: Identify independent risk factors for methadone-induced QTc interval~     prolongation in patients undergoing care in a narcotic treatment center.~      Research Design: This will be a retrospective/prospective analysis of ECGs and health~     information from patients receiving methadone therapy in the Eskenazi Health Midtown~     Narcotic Treatment Center in Indianapolis, IN. Currently, at the Midtown Narcotic Treatment~     Center, baseline 12-lead ECGs are recorded for all patients prior to initiation of methadone~     therapy; follow-up ECGs are obtained approximately 2 weeks after methadone initiation only~     in patients with a baseline prolonged QTc interval. At the start of the study,~     methadone-treated patients who have not had follow-up ECGs on methadone therapy will be~     identified and contacted prospectively. Those consenting to participation will undergo a~     follow-up 12-lead ECG to determine QTc interval during methadone maintenance therapy. For~     all patients, retrospective analysis of the electronic medical record will be performed to~     document sex, pregnancy status, age, family history, current and past medical history, and~     concomitant use of prescribed, over the counter, and illicit drug use with the aim to~     identify all potential risks. QTc interval prolongation will be defined as QTc interval ≥~     500 ms or an increase in QTc interval of ≥ 60 ms compared with the baseline QTc interval.~     Electronic health information variables will be compared in patients who develop~     methadone-associated QTc interval prolongation versus those who do not using univariate~     analysis. Patients with prolonged QTc interval at baseline will be excluded from the study.~      Specific Aim 2: Validate the handheld AliveCor® smart phone/tablet iECG device as a simple,~     rapid method of monitoring QTc intervals in methadone-treated patients in a narcotic~     treatment center.~      Research Design: A separate cohort of patients will be utilized to validate the AliveCor®~     device for use in measuring QTc intervals in patients initiated and maintained on methadone~     in a narcotic treatment center. Twelve lead ECGs and simultaneous single lead ECGs using the~     AliveCor® device will be recorded for all newly enrolled patients at baseline and again~     after six weeks of methadone therapy. The QTc identified by the 12-lead ECG will be compared~     to the single lead ECG for all baseline and follow-up recordings to validate the use of the~     AliveCor® device for potential use in narcotic treatment centers to reduce cost and save~     time. Comparison of QTc intervals between the 12-lead and single lead measurements will be~     performed using the Bland-Altman method for analysis of measurement agreement. The mean and~     95% confidence interval of the difference in QTc interval between the two methods will be~     calculated.~      This will be a pilot study to justify a larger extramural study to develop and validate a~     risk score for methadone-induced QTc interval prolongation and to use the handheld ECG~     device for QTc interval monitoring in patients identified as high-risk using this risk~     score. Our rationale is that identification of risk factors for methadone-induced QTc~     interval prolongation and quantification of degree of risk conferred by each risk factor~     will ultimately reduce the incidence and risk of QTc interval prolongation through targeted~     ECG monitoring of patients at highest risk and modulation of modifiable risk factors.~   "
12117|NCT02898571|"~     The aim of this project is to measure the differences in antioxidant capacity at different~     time points after consuming a single dose of antioxidant-containing drink (vitamin C or~     epicatechin) compared with a control drink in 10 volunteers, and then match the data with~     the proposed modelling corresponding to either homeostasis or accumulation. Additionally it~     will also determine whether the effect on changes of antioxidant capacity in response to~     epicatechin and vitamin c is equal.~   "
12118|NCT02898558|"~     This study explores the possible implications of the increase in perceived body size for~     rehabilitation of motor functions. In a recent study we have tested if motor abilities of~     patients with stroke improve wearing magnifying lenses, showing that a beneficial effect of~     magnifying lenses can be observed in some patients. In the present study, we will identify~     12 patients from this cohort who demonstrated an improvement greater than 10% in one or two~     motor task when wearing magnifying glasses. These participants will be invited to take part~     in a clinical study in which they will undergo a training phase: subjects will wear~     magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle;~     a log will be kept to document participation. Participants' performance on different motor~     tasks will be assessed before, immediately after and 1 month after the training session.~     Standardized measures of motor performance will include the the Action Research Arm test and~     the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will~     undergo grip strength, finger tapping tasks and a reaching and grasping task. We expect the~     repeated use of magnifying lenses to generate an improvement of patients' performance across~     tasks and this effect to be persistent in time.~   "
12119|NCT02898545|"~     This study will evaluate the recurrence rates of atrial fibrillation that develops in the~     hospital following non cardiac procedures or surgeries or acute medical illnesses.~   "
12120|NCT02898532|"~     Practising target shooting sport requires focused attention and motoric steadiness. Parental~     reports suggest that children with attention-deficit/hyperactivity disorder (ADHD) benefit~     from participating in target shooting sport in Danish Shooting Associations.~      Aim: This study aims at examining if and to which extent target shooting sport in children~     with attention difficulties reduces parent- and teacher-reported severity of~     inattentiveness, hyperactivity, and impulsivity, and improves the children's well-being and~     quality of life.~   "
12121|NCT02898519|"~     Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira)~     growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas~     aera, and especially in Reunion Island, as compared to metropoly, it is considered as a~     major public health issue.~      An important inter-individual variability in humoral immune response suggests that~     vaccination should be recommended in exposed subjects.~      This cohort study aimed to determine if subjects that have been infected by leptospirosis~     for 1 to 7 years still remain immunized, and then do not need vaccination.~   "
12122|NCT02898506|"~     The objective of the trial is to study whether daily treatment with liraglutide improves~     endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is~     tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet~     autoantibodies and have dysglycemia.~   "
12123|NCT02898493|"~     The evaluation of quality of life in health is particularly important for measuring the~     impact of the chronic diseases. The scales of measure constitute the main measurement tool~     in clinical trials because of their psychometrics properties and of their ease of use.~      Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions~     questionnaire ( EQ-5D) were widely validated in various populations, of which the population~     of the diabetics patients. Both scales have validated versions in French.~      In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject~     of many clinical and epidemiological trials. One of the difficulties encountered during the~     implementation of these studies is the absence of measurement tools validated for these~     populations.~      Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and~     Reunion Island, adapting and validating these scales according to an identical procedure in~     Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French~     versions of these scales in their populations of type II diabetics patients.~   "
12124|NCT02898480|"~     Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue~     against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown~     whether this can be used in retinal vascular occlusive diseases. The purpose of the present~     study is to examine whether the autoregulation of retinal vessel diameters in normal persons~     change after remote ischemic conditioning.~   "
12125|NCT02898467|"~     Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to~     rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs)~     represent about 70% of leukocytes and may constitute a source of proteases and oxidants that~     favour plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque~     of non-diabetic versus type 2 diabetic patients. For this purpose, investigators will~     quantify the presence of cell-free DNA, that reflect the formation of neutrophil~     extracellular traps (NETs) in carotid endarterectomy samples.~   "
12144|NCT02898220|"~     The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network~     has been established by the National Institute of Diabetes and Digestive and Kidney Diseases~     (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the~     study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and~     Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously~     undertaken. Patients with IC or CP are being recruited for a new study called the~     Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This~     research study will recruit Control Participants to better understand the symptoms of~     individuals with some form of IC or CP. As with many chronic pain disorders, IC and CP are~     poorly understood, and treatment is often not helpful. The goal of this study is to better~     understand how pain is felt in people with IC or CP and the investigators hope that this~     study will lead to improvement in the treatment of IC and CP.~   "
12790|NCT02889822|"~     Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and~     tolerability of single/multiple-dose administration of different doses of Alprostadil~     Liposome for Injection as well as to confirm the safety dose range.~   "
12126|NCT02898454|"~     Primary Objective:~      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone~     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and~     endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In~     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses~     will be also a co-primary objective.~      Secondary Objectives:~        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).~        -  To evaluate the efficacy of dupilumab in improving sense of smell.~        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses~          (Primary objective for Japan).~        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment~          with oral corticosteroids or NP surgery.~        -  To evaluate the effect of dupilumab on patient reported outcomes and health related~          quality of life outcome by sinonasal outcome test-22 (SNOT-22).~        -  To evaluate efficacy with various regimen.~        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and~          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated~          respiratory disease [NERD]).~        -  To evaluate the safety of dupilumab in patients with bilateral NP.~        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of~          treatment-emergent anti-drug antibodies (ADA).~   "
12127|NCT02898441|"~     The present study is a randomized controlled trial of LDCT screening for lung cancer versus~     usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active~     arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in~     usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung~     cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples~     were stored from the Active arm in a Biobank. Management of positive screening test was~     carried out by a pre-specified protocol.~   "
12128|NCT02898428|"~     With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels~     and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and~     formula feeding new mothers with type 1 diabetes at the second after delivery diabetes~     control compared with the first after delivery diabetes control at Steno Diabetes Center.~   "
12129|NCT02898415|"~     Liver transplantation (LT) is one of the curative treatment options for patients with HCC~     associated to chronic liver disease (cirrhosis). All current international guidelines~     recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to~     select patients affected by HCC for LT was originally proposed with the Milan criteria.~     These criteria were based on pathologic assessment of number and size of the HCC nodules on~     the explanted liver. Subsequently, many authors proposed the expansion of such restrictive~     criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on~     different combinations of morphologic parameters, have been defined on the pathologic~     staging of the tumor made on the removed liver, namely after LT, once decision on treatment~     and treatment itself could not be changed Although post-LT pathology / pre-LT radiology~     correlation have improved over time, significant biases still affect clinical assessment of~     HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust~     evidence indicates that other biological markers of aggressiveness (such as α-FP levels and~     clinical response to bridge therapies) have to be added when evaluating pre-operative~     variable Although many studies have been conducted, prognostic calculators of~     cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet~     available. Such models should be able to provide survival estimates based on pre-treatment~     oncologic variables.~      The main goal of the study is the definition of a cancer-specific prognostic model based on~     pre-operative features (radiologic staging and α-FP levels) of a wide population of patients~     who underwent LT for HCC.~      Considering the competitive risk of cancer-specific mortality and death due to other causes,~     the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the~     base of pathologic staging~   "
12130|NCT02898402|"~     Emergent and infectious diseases are a public health priority on Reunion Island. Amongst~     public health threats, the infection due to Coxiella burnetii (Q fever) seems to have~     appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one~     probable case with a goat farmer.~      According to the investigator, the diffusion of C. burnetti is more ancient and such~     diagnosis have been made in the last 30 years with 80 positive serologies identified between~     2005 and 2011.~      Considering the high epidemic power of this disease, its often silent clinical expression~     and its life-threatening condition, the principal investigator wishes to perform a~     sero-epidemiological study in order to establish or to reject the risk of emergence of Q~     fever in Reunion island.~      The study will be performed on pregnant women because Q fever is responsible for particular~     complications during pregnancy and because the number of pregnancy followed on Reunion~     island is stable from one year to the other. The pregnant women population presenting the~     same exposure criteria as the general population, this population will be used to~     extrapolate to the general population of the island.~   "
12131|NCT02898389|"~     The primary objective of this study is to show that cardiovascular risk factors associated~     with the chronic elevation of arterial resistance may be associated with false profiles of~     intracranial hypertension during transcranial doppler ultrasound of the middle cerebral~     arteries in intensive care unit patients. A false profile of intracranial hypertension is~     defined by a high pulsatility index without any intracranial pathology.~   "
12132|NCT02898376|"~     This study evaluates the dermatological life quality six months after spa cares in patients~     with severe late toxicity involving the skin and / or soft tissues after postoperative~     radiotherapy for breast cancer. Half of the patients will be treated with a combination of~     pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive~     skin-oriented spa cares in addition.~   "
12133|NCT02898363|"~     Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in~     France, develop as many cancers as persons in the general population. However, their tumors~     are different by their particular organ distribution, the age of onset, the biological~     background (2,000 genetic conditions are associated with an intellectual disability) and~     above all the unusual clinical presentation. These cancers are not well known from~     physicians, carers and families, and often discovered late. A recent review of the~     literature shows many inequalities in the prevention, monitoring, screening, diagnosis and~     treatment of cancer in these patients. Currently, no population study on clinical features~     and stage at diagnosis of cancer in PWIDs is available. No interventional research study has~     been conducted on this subject.~      Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result~     from a direct link between intellectual disability and cancer, but are related to diagnosis~     difficulties of these tumors which are not well known, and to difficulties of communication~     with these patients who do not express easily their symptoms, particularly pain.~   "
12136|NCT02898324|"~     Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined~     as a systematic aggressive behavior against a victim who cannot defend himself or herself.~     Victims suffer many consequences such as social isolation, psychological maladjustment, and~     self-injury behavior. Additionally, bullies have a higher risk for conduct problems and~     substance use disorders. These problems appear to last in time, affecting mental health even~     years later since the experience of bullying.~      There are few studies in Chile aiming to determine the prevalence of bullying. In one of~     such studies, 47% of the students reported having been bullied during the last month before~     the application of the questionnaire. Even though there are many initiatives and guidelines~     in Chile supported by the government to help schools in order to deal with bullying, there~     is no any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an~     anti-bullying program.~      KiVa anti-bullying prevention program contains universal and indicated actions. Main~     universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and~     an online game, which have the aim to raise awareness of the role of the group in bullying,~     increase empathy and promote strategies to support victims. Indicated actions consist of a~     set of discussion groups with the victims and with the bullies with proper follow-up.~      The aims of this study are: 1) To develop a culturally appropriate version of the Kiva~     material, and 2) to test its effectiveness of KiVa program with and without the online game,~     to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT~     design with three arms: i) KiVa full program group, ii) KiVa without online game program~     group, and iii) Control group.~   "
12137|NCT02898311|"~     This study evaluates the success rate, as the biological and prosthesis complications, of~     posterior single-unit implants immediately loaded with a chair side Computer-Aided Design~     and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4~     and 5 years.~      Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The~     time and cost benefit of the presented digital workflow, as patient centered outcomes will~     also be evaluated.~   "
12138|NCT02898298|"~     The purpose of this study is to evaluate the efficacy of a novel positive emotion regulation~     intervention that aims to increase positive emotions and improve emotion regulation skills~     in children, adolescents and young adults. The study focuses on individuals with a~     developmental disorder such as Autism Spectrum Disorder and other Learning or Developmental~     Disabilities in comparison to typically developing (TD) controls. Participants will complete~     a psycho-educative training to learn about positive emotions and how to increase them in~     their daily lives. Participants are expected to benefit from the training, which will be~     evident in a change in emotion experience, emotion regulation strategy use, and well-being.~     Emotion regulation efficacy will be related to symptom severity (autistic symptoms),~     alexithymia and problematic behaviors.~   "
12139|NCT02898285|"~     The primary objective of this investigation is to test the efficacy of two sport~     participation formats (individual sport, team sport) on key psychosocial outcomes compared~     to a non-sport condition among parents of young children who were not participating in sport~     at baseline of the study.~      Research of this type is important because parents represent a group dealing with numerous~     challenges and this is a period of time shown to have the greatest decline in physical~     activity. Furthermore, parents could reap great benefits in psychological health through the~     increase in physical activity and sport participation.~      It is hypothesized that participation will be predicted by sports commitment as per the~     tenets of the Sport Commitment Model, and commitment will be predicted primarily by~     enjoyment (+), social constraints from family obligations/involvement alternatives (-),~     followed by social involvement opportunities/personal investments (+).~   "
12140|NCT02898272|"~     The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in~     whom the University of Pittsburgh has already obtained baseline and five year data, in order~     to enhance bone mineral density and vascular function data collection from minority smokers.~     Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density.~     Non-invasive vascular studies will be performed to measure endothelial function.~     Questionnaires regarding symptoms and activity levels will be administered and a blood~     sample will be obtained in participants in which blood samples are not already available~     from the COPDGene study visits.~   "
12141|NCT02898259|"~     A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as~     Front-line Therapy for High Risk Indolent B cell Lymphoma~   "
12142|NCT02898246|"~     The aim of the study is to evaluate the psychometric properties of the newly developed Fear~     of Activity in Situations - Heart Failure (FActS-HF 15) scale. The FActS-HF 15 is a~     questionnaire assessing fear of physical activity (fear of movement) in patients with~     chronic heart failure. FActS-HF 15 assesses cognitions and emotions that can occur during~     physical activity, independent of avoidance behavior. Firstly, the study aims at evaluating~     the instrument's reliability and validity and to investigate associations of fear of~     physical activity with demographic, medical, and psychosocial patient characteristics.~     Secondly, the study aims at assessing everyday physical activity using accelerometric~     measures to test the hypothesis that fear of physical activity in patients with heart~     failure is related with lower actual physical activity.~   "
12143|NCT02898233|"~     The purpose of this study is to better understand how low-level light therapy (LLLT) can be~     used to augment the antidepressant effects of Deprexis, an internet-based treatment program~     for depression, for participants with current major depressive disorder. The researchers~     will administer active and placebo LLLT to the right forehead of participants who show an~     improvement of at least 10% in depressive symptoms from baseline after two weeks of Deprexis~     treatment.~      Hypothesis: Participants who receive active LLLT will show a greater reduction of depressive~     symptoms than participants who receive placebo LLLT.~   "
12145|NCT02898207|"~     This phase I trial studies the side effects and best dose of olaparib and Hsp90 inhibitor~     AT13387 when given together in treating patients with solid tumors that have spread to other~     places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary~     peritoneal, or triple-negative breast cancer that has come back. Olaparib and Hsp90~     inhibitor AT13387 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
14210|NCT02871336|"~     This data base has been set in order to gather medical and surgical information from~     patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or~     Assistance Publique des Hôpitaux de Marseille, France.~   "
12146|NCT02898194|"~     Background:~      Some people cannot make medical treatment decisions on their own. The people who make~     decisions on their behalf are called medical surrogates. Sometimes surrogates cannot predict~     which treatment course the person or their loved ones would have chosen. The surrogates~     often become distressed because of making these decisions. Researchers think a tool called a~     Patient Preference Predictor (PPP) may be able to make the process easier. The PPP would~     predict what treatment the person would want. This is based on treatment preferences of~     similar people in a similar circumstance. Researchers want to interview surrogates to~     explore their views on the PPP.~      Objective:~      To explore surrogates views on incorporating a PPP into shared medical decision-making.~      Eligibility:~      People 18 years or older who:~      Have acted as a surrogate medical decision-maker within the past 3 years. This includes~     decisions about~      treatment, medication, hospice care, hospital admission, or discharge.~      Are not pregnant~      Design:~      Participants will be screened by meeting with clinicians in person or by phone to discuss~     the study.~      Participants will take part in a focus group. This is a small group of people discussing~     their thoughts and opinions. This will last for about 2 hours.~      Participants will be served a light meal.~      Participants will provide information about themselves and their views. They will talk about~     their past experiences making medical decisions for someone. They will discuss how they felt~     about these decisions.~      The PPP will be explained to participants. They will give their views on it.~      The research team will audio record the focus group and take notes.~      Participants will fill out questionnaires.~   "
12147|NCT02898181|"~     Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is~     associated with increased systemic inflammation. Previous studies have demonstrated~     increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1),~     interleukin-6 (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in~     patients with heart failure (HF). Increased activity of sympathetic nervous system in ADHF~     is linked to inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated~     no significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS)~     is a non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve~     stimulation is thought to increase the parasympathetic activity and suppress the sympathetic~     activity. Clinical studies of vagal stimulation in chronic HF have been negative. Recent~     experimental and clinical data suggest that low level tragus nerve stimulation (LLTNS) may~     produce the same desired neuromodulator effect compared to LLVNS. It is however unknown if~     LLTNS in ADHF will directly lead to a reduction in the levels of pro-inflammatory cytokines~     (CRP, IL-1, IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker~     IL-10.The objective of this proposal is to determine the impact of LLTS on inflammatory~     cytokines in patients with ADHF.~      Patients will be randomized to either active or no stimulation(~8 hours daily). Serum~     collected will (post admission and on days 2, 3 and 4 post admission) will be used for~     cytokine measurement. This investigation will likely establish the first evidence of effects~     of LLTS on suppression of inflammation in patients presenting with ADHF.~   "
12148|NCT02898168|"~     Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in~     the daily life of patients. It is considered significant effects on their Quality of~     Life(QOL).~      Further methods of rehabilitation are required for convalescent patients to recover their~     function soon and better, due to a multitudes of recovery patient with troubles such as gait~     problem.~      This trial is studying to investigate the effects of gait training with a functional~     electrical stimulation (FES) `WalkAide[R](WA)' to improve the lower-limb function and~     ambulation in convalescent stroke patients.~   "
12149|NCT02898155|"~     Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To~     Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work~     Unveils Considerable Geographic Variation In The Rate Of Pah In France And Suggest That~     Primary Care Organization Might Play A Role In This Variation. However, A Limitation Of This~     Work Lies In The Lack Of Data On Actual Primary Care Utilization.~      The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially~     Avoidable Hospitalizations At the Zip Code Level, In The French Region~     Languedoc-Roussillon-Midi-Pyrénées.~      The investigator will implement An Ecological Approach In Which The Geographic Variation In~     The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate~     Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.~   "
12150|NCT02898142|"~     Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of~     intestinal triglyceride rich lipoproteins in patients with isolated fasting~     hypertriglyceridemia.~      The objective of this study is to compare the serum apoB48 rate after a standardized load~     test, among patients with isolated hypertriglyceridemia and patients with metabolic~     syndrome.~   "
12151|NCT02898129|"~     The research question is Are the different types of house in Ho Chi Minh city equally~     contributing to chronic respiratory diseases?.~      According to this question, a cross-sectional and explorative study was set up to explore~     the differences in the environmental characteristics and prevalence of chronic respiratory~     diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in~     100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and~     apartment) from November 2013 to June 2015. It included measures by environmental devices,~     questionnaires and indoor activities diaries.~      This study will aim to collect information about the prevalence of chronic respiratory~     diseases (CRDs) inside those house types to understand more about role of house types in~     developing CRDs.~      The objective is:~        1. to evaluate the relationships between the type of house and lung function of~          inhabitants in each housing type.~        2. to evaluate the effects of environmental risk factors in each house type on prevalence~          of CRDs~   "
12152|NCT02898116|"~     This is an open-label, multicenter, single-arm study to evaluate the safety and preliminary~     efficacy of a targeted therapy for NSCLC in combination with a checkpoint inhibitor:~        -  Ensartinib (X-396), an anaplastic lymphoma kinase (ALK) Inhibitor and~        -  Durvalumab (MEDI4736), an anti-programmed cell death ligand 1 (PD-L1) antibody.~   "
12174|NCT02897830|"~     Open-label study to evaluate the safety and efficacy of Ixazomib in combination with~     Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The~     patient population will consist of adult men and women up to 65 years, who have a confirmed~     diagnosis of MM who meet eligibility criteria.~   "
12153|NCT02898103|"~     The moderate-to-severe pain many patients experience following orthopedic surgery is often~     treated with opioids, which are associated with side effects such as nausea/vomiting,~     sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia~     with fewer side effects may be provided with a continuous peripheral nerve block, which~     involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s)~     supplying a surgical site. Local anesthetic is introduced via the catheter. However, there~     are major problems with continuous nerve blocks that have dramatically limited their use~     outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or nerve~     modulation is an alternative method of pain control involving the insertion of an~     electrical lead through an introducing needle—obviating an open surgical incision for~     placement—followed by the introduction of electric current to produce analgesia. This~     modality has been used to treat chronic pain, but it has not been evaluated with a~     randomized, controlled study when applied to acute pain management (post-surgical~     analgesia). This temporary therapy has multiple theoretical benefits over existing~     analgesics, such as a lack of systemic side effects (e.g., nausea, respiratory depression),~     an absence of induced muscle weakness, and a reduced risk of adverse events (e.g.~     infection). The purpose of the proposed randomized, double-masked, placebo-controlled,~     crossover, feasibility study is to explore the possibility of treating postoperative pain~     with ultrasound-guided percutaneous PNS and, if so, to help power a subsequent definitive~     randomized, controlled trial.~   "
12154|NCT02898090|"~     This research focuses on the development and validation of indicators on the appropriateness~     of oral anticoagulant prescriptions. The investigators want to propose transferable tools to~     other healthcare institutions to allow automated construction of indicators as part of a~     structured approach to improve future practices. The main objective of the study is to~     develop indicators on the appropriateness of oral anticoagulant prescriptions in adult~     medicine automated from the hospital information system and to assess their criterion~     validity.~   "
12155|NCT02898077|"~     The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab~     in participants with gastric and gastroesophageal cancer.~   "
12156|NCT02898064|"~     Consenting patients with multiple myeloma (MM) will be randomly allocated to receive either~     standard medical treatment (chemotherapy, radiotherapy, pain-killing medication) alone or~     standard medical treatment plus a brace. Patients will be regularly evaluated in research~     clinics; the results data will inform the design of a full trial. Information will be~     collected to inform a list of requirements a centre needs to have in place to run an RCT of~     these interventions.~   "
12157|NCT02898051|"~     Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment~     of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a~     high risk of recurrent thromboembolism. The high rate of recurrence may result from~     alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare~     the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer~     treated with curative dose of low molecular weight heparins (LMWH) for venous~     thromboembolism (VTE). The secondary purposes are 1/ to study the correlation between~     anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature~     of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients~     treated with LMWH for VTE.~   "
12158|NCT02898038|"~     Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS~   "
12159|NCT02898025|"~     This study aims to evaluate the effectiveness of the low level laser therapy and~     interferential current in 168 patients with knee osteoarthritis~   "
12160|NCT02898012|"~     The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a~     Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the~     efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70~     years and a KPS <70.~   "
12161|NCT02897999|"~     The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of~     single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult~     volunteers~   "
12162|NCT02897986|"~     Cancer remains the first cause of death due to disease in children and adolescents despite~     important progress and 70% of the survivors present sequelae. It is therefore mandatory to~     generate new and preferably less toxic treatment strategies relying on new anticancer~     agents, and/or new combinations or schedules of administered compounds.~      Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a~     daily/weekly basis. MC has been showed to be a safe and effective way to administer~     chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects.~      Drug repositioning consist in using non-anticancer drug for which anti-cancer properties~     have been unveiled. Propranolol is a non selective beta-blocker initially used to treat~     hypertension but recently its anticancer properties have been discovered. The place of~     Betablockers as anticancer agents is supported by both preclinical and epidemiologic data.~     The investigators have showed that the use of betablockers could sensitize breast cancer,~     angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an~     anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively~     their potential in adults with cancer but none in children so far.~      The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral~     metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a~     rolling six design and a dose escalation with thrice weekly oral vinorelbine only plus~     addition of daily oral propranolol after completion of the first cycle. PK analysis of~     vinorelbine and propranolol will be performed. Once the recommended dose of the combination~     established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as~     beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be~     evaluated.~      This will provide a well tolerated, all oral combination for patients with~     refractory/relapsing tumours. This combination could also be then proposed as a maintenance~     for instance in patients with rhabdomyosarcoma or neuroblastoma.~   "
12163|NCT02897973|"~     The prevalence of low back pain among persons with unilateral lower limb amputation is~     significantly higher than the rate experienced by the general public. Chronic pain,~     including low back pain, limits functional independence and negatively impacts quality of~     life. As such, this project will investigate the role of a biomechanical casual pathway in~     the development of low back pain; to do this, the investigators will explore the~     relationship between the adopted neuromuscular patterns post-amputation to perform~     activities of daily living and the risk of developing spinal tissue damage.~   "
12175|NCT02897817|"~     The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to~     injectable MTX remained strong or improved according to patient-reported outcome.~   "
13573|NCT02879747|"~     The objective was to study whether normal growth velocity can be maintained with adapted GH~     dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled~     catch up growth (=difference to target height reached, less than - 0.6 SDS).~   "
12164|NCT02897960|"~     Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute~     bronchiolitis. One third of these infants will develop recurrent episodes, leading to the~     diagnosis of infant asthma. Nowadays, no available treatment shortens the course of~     bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our~     hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will~     help to select infants who will benefit from anti-asthma therapy. In this setting the~     diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of~     clinical value. The investigators developed a wheezing recognition algorithm from recorded~     respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016).~     The objectives of the present cross sectional, observational study are 1/ to further~     validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital~     for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold~     standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent~     analysis by two experienced pediatricians.~   "
12165|NCT02897947|"~     There is no international consensus on evaluation and surgical treatment of Lumbar Spinal~     Stenosis (LSS). The indication for operative treatment is relative, and the variation in~     surgical rates and procedures is significant, both within and between countries.~     Understanding practice-based variety is critical since these differences may reflect a~     disparity in quality of the health care in different institutions, regions, or countries.~     Norway, Sweden, and Denmark do all have National spine registers for research and quality~     assessment. Comparing indications for surgery, selected procedure, patient reported~     outcomes, and factors predicting outcome after surgery for LSS between these countries could~     provide information about optimal indications and strategy for surgery. Register-based~     studies have advantages such as large sample sizes and high external validity, but also~     limitations such as lower follow-up rates, and inferior data quality compared to clinical~     trials.~      Hypotheses: Between these three countries, there are no differences in (i) indications for~     surgery, (ii) patient-reported outcome after surgery or (iii) risk factors associated to~     outcome are similar.~   "
12166|NCT02897934|"~     The objectives of this work are threefold:~        1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major~          breast cancer surgery~        2. To evaluate objective indices of patient recovery following anaesthesia and surgery in~          a 23 hour model of care~        3. To evaluate patient satisfaction with their care pathway~   "
12167|NCT02897921|"~     Many myopathies are inherited in a recessive manner, but in some of these recessively~     inherited disorders, clinical manifestations may potentially manifest in carriers of just a~     single mutation.~      The aim of the study is to describe the clinical characteristics of single mutation carriers~     of recessive myopathy, through measuring serum creatine kinase, muscle strength, muscle~     degeneration (by MRI) and heart affection. The investigators will do this by blood sampling,~     Biodex 4 Isokinetic Dynamometer, MRI analysis, ECG, Holter monitoring, and echocardiography.~      The aim is further to describe whether these characteristics are found primarily with~     specific mutations.~   "
12168|NCT02897908|"~     The primary goal of this study is to establish a database of people with varying levels of~     hepatic fibrosis and various etiologies of liver disease for use in future research~     protocols.~   "
12169|NCT02897895|"~     The study is an interventional, multicentre, prospective, randomized, controlled,~     single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin~     (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant~     center and according to the underlying lung disease (affected with cystic fibrosis or not)~     and will be randomized to either evaluation of calcineurin activity (CN-a) in combination~     with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to~     compare the proportion of acute rejection that has required a specific curative treatment at~     6 months after transplantation between patients in the two groups.~   "
12170|NCT02897882|"~     The objective of this project is to estimate the frequency and the characters of the chronic~     pains by a follow-up which begins during the registration on the waiting list of transplant~     and which ends at the end of the third year following the lung transplantation. It is a~     forward-looking study of prevalence entering within the framework of the common care. After~     lung transplant, pain will be evaluate with questionnaires every day during the~     hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.~   "
12171|NCT02897869|"~     Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study.~     Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or~     combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects.~     The study consists of an eligibility screening period, up to 3 treatments periods and a~     follow-up visit.~   "
12172|NCT02897856|"~     The goal of this study is to prove that intramuscular midazolam is more effective than~     buccal midazolam in cessation of seizure activity with comparable side effects.~   "
12173|NCT02897843|"~     Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric~     disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction~     continues to be a frequent adverse effect. Declarative memory and less so selective memory~     are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It~     is hypothesized that memory impairments are due to ECT induced disruptions on long term~     potentiation as well as in cerebral flux and glutamatergic and cholinergic systems.~     Different pharmacological agents for the treatment of ECT induced cognitive dysfunction have~     been tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid~     hormone, and stimulants have been used with equivocal results, and no controlled studies~     showed clear efficacy.~      Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation~     treatment that uses direct electrical currents to stimulate specific parts of the brain.~     Electrical currents are applied constantly at low intensities (1-2 mA) over a long period,~     usually in minutes (5-30 minutes), to achieve changes in cortical excitability by~     influencing spontaneous neural activity. There are two types of stimulation with tDCS:~     anodal and cathodal stimulation. Anodal stimulation acts to excite neuronal activity while~     cathodal stimulation inhibits or reduces neuronal activity. Several studies demonstrated~     moderate to strong effect sizes of tDCS in various neurocognitive and neuropsychiatric~     settings. Majority of studies show positive effects of tDCS on cognitive functioning among~     healthy volunteers and subjects with neurological or psychiatric conditions. Beneficial~     effects of online stimulation applied over the left dorsolateral prefrontal cortex have been~     reported for working memory, attention and information processing in depressed patients. To~     the investigators' knowledge no studies have evaluated the potential efficacy of tDCS for~     the prevention of ECT induced cognitive adverse effects.~      In the current study, the investigators propose a double blind, randomized controlled trial~     to test the use of tDCS as a strategy to prevent or mitigate the memory impairments~     frequently associated with an ECT course.~   "
12176|NCT02897804|"~     The overall objective of the proposed research is to reduce the incidence of sexually~     transmitted infections (STIs) among college students. The investigators propose to~     accomplish this by using the innovative, engineering-inspired multiphase optimization~     strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable~     internet-delivered behavioral intervention targeting the intersection of alcohol use and~     sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college~     students is diagnosed with an STI at least once during their college experience. Sexual~     activity when drinking alcohol is highly prevalent among college students. Alcohol use is~     known to contribute to the sexual risk behaviors that are most responsible for the~     transmission of STIs, namely unprotected sex, contact with numerous partners, and hook-ups~     (casual sexual encounters). Few interventions have been developed that explicitly target the~     intersection of alcohol use and sexual risk behaviors, and none have been optimized. In~     order to reduce the incidence of STI transmission among this and other high-risk groups, a~     new approach is needed. MOST is a comprehensive methodological framework that brings the~     power of engineering principles to bear on optimization of behavioral interventions. MOST~     enables researchers to experimentally test the individual components in an intervention to~     determine their effectiveness, indicating which components need to be revised and re-tested.~     Given the high rates of alcohol use and sex among college students, the college setting~     provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The~     proposed study will include a diverse population of college students on 4 campuses which~     will increase the generalizability of the findings. The specific aims are to (1) develop and~     pilot test an initial set of online intervention components targeting the link between~     alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized~     preventive intervention, and (3) evaluate the effectiveness of the newly optimized~     preventive intervention using a fully powered randomized controlled trial (RCT). This work~     will result in a new, more potent behavioral intervention that will reduce the incidence of~     STIs among college students in the US, and will lay the groundwork for a new generation of~     highly effective STI prevention interventions aimed at other subpopulations at risk.~   "
12177|NCT02897791|"~     Main idea perception of written stories and in pictures among impaired right hemisphere~     patients Abstract The right hemisphere is considered to complement the language processing~     abilities of the opposite hemisphere; it is responsible for the processing of secondary and~     unusual characteristics of linguistic stimulates. This processing enables, among other~     functions, the comprehension of metaphors and humor. Additionally, it enables the execution~     of inferring from spoken and written discourse. Studies which deal with common impairments~     among right-hemisphere-damaged (RHD) individuals, found that inference processing of written~     stories and narrative sequences presented in pictures was impaired. This impairment could~     damage the ability to create global coherence, which is an important component of central~     theme comprehension of different types of narrative. Another important component is~     superstructures, schemas which aid creating, remembering and producing the main ideas of~     spoken and written discourse. Other studies consider impairment in creating global~     coherence, or Theory of Mind impairment, as the source of central theme comprehension~     impairment among RHD individuals.~      Discourse is an integral part of interpersonal communication, and of proper social conduct.~     The themes chosen for conversation reflect the functional role of discourse from semantic~     and pragmatic points of view.~      The aim of the current study is to deepen the current knowledge concerning central theme~     comprehension among RHD individuals following cerebrovascular accident (CVA), in two genres~     of written discourse (classic stories and stories with a twist), and in situations~     represented by single pictures. Unlike written stories, the extraction of the central theme~     out of a single picture requires focusing on a single situation and relying on~     non-linguistic visual information. Differences concerning central theme comprehension in the~     different discourse genres and in the pictures might be able to assist in selecting~     diagnostic and therapeutic tools designed to work on high cognitive-linguistic abilities,~     which are usually impaired among RHD individuals. In later stage, these tools are meant to~     help improving RHD individuals' spontaneous narrative skills.~      The study will include 20 RHD adults following CVA, and 20 healthy adults without any known~     damage to the right hemisphere. The two groups will be matched concerning sex, age,~     educational level and socio-economic status. The subjects will perform the study tests~     during three sessions, 60 minutes each. The screening tests will include language diagnosis~     - Western Aphasia Battery (WAB), and reading test no. 37 included in the Psycholinguistic~     Assessments of Language Processing in Aphasia's battery (PALPA). Patients diagnosed with~     aphasia will be excluded from research. The research tests will include: central theme~     comprehension test in stories and pictures, including classic stories, stories with a twist,~     and pictures of different situations (each will be accompanied by a multiple-choice question~     concerning the central theme), sub- exanimations taken from Frigbi battery designed to~     evaluate memory and phonological memory capacity, Raven's Progressive Colored Matrices test~     designed to evaluate pre-morbid abilities (non-linguistic), Theory of Mind (T.O.M)~     evaluation test, and tests designed to evaluate central coherence impairment: Navon Figures~     test for evaluation of global visual perception impairment, and Rey-Osterrieth Complex~     Figure Test (RCFT) - Recall Form test for evaluation of visual-perceptive organizational~     ability, and non-verbal memory. The performances of the two groups will be compared in each~     test using statistical tests. In addition, the interaction between all variables will be~     measured.~   "
12178|NCT02897778|"~     The purpose of this study is to evaluate the effect of entinostat on heart rate and other~     electrocardiogram parameters. This study will also evaluate the safety and tolerability of~     entinostat, as well as pharmacokinetic and pharmacodynamic parameters.~   "
12179|NCT02897765|"~     The purpose of this study is to evaluate f the treatment with NEO-PV-01 + adjuvant in~     combination with nivolumab is safe and useful for patients with certain types of cancer. The~     study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a~     substantial improvement over other available therapies such as nivolumab alone. All eligible~     patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.~   "
12180|NCT02897752|"~     RATIONALE:~      The previous study resulted that the gait training using Functional Electrical Stimulation~     (FES) improved the ankle joint function and the walking ability for the chronic stroke~     patients with foot drop.~      In addition, the further exploratory study in multicenter obtained the result that the~     training with WA were especially good adaptation to the patients who have slight paralysis~     and can walk independently.~      PURPOSE:~      This multicenter prospective trial is studying to reveal whether the gait training with the~     WalkAide[R](WA) for chronic stroke patients who can walk independently is superior to gait~     training with a physical therapist.~   "
12181|NCT02897739|"~     Tako Tsubo Cardiomyopathy (TTC), also known as Broken Heart Syndrome, is a disorder of the~     heart that occurs most commonly in women (although it occasionally occurs in men) and is~     usually related to a stressful event. Symptoms are often similar to a heart attack, and~     include chest pain and shortness of breath. Although Tako Tsubo Cardiomyopathy is not a new~     medical condition, it has not been widely recognised until the last decade. Currently the~     investigators don't have an exact understanding of how or why the heart is affected in this~     way, and so the investigators are conducting a study to help understand what causes Tako~     Tsubo Cardiomyopathy.~   "
12182|NCT02897726|"~     The purpose of this study is to evaluate and compare the safety and pharmacokinetics of~     NVP-1402 and NVP-1402R in healthy male subjects.~   "
12183|NCT02897713|"~     Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse~     outcome. According to guidelines released from authority organizations, enteral nutrition~     (EN) should be prior approach for critically ill patients. However, initiation and delivery~     of EN during the early period of ICU admission are frequently hampered, which results in~     underfeeding. The investigators speculate whether an intensive enteral nutrition strategy~     could reinforce the delivery of EN thereby improving outcomes. In this multi-center,~     prospective, randomized parallel clinical trial, the investigators aim to assess the~     feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated~     patients.~   "
12184|NCT02897700|"~     The overarching purpose of this study is to determine if the mainstay chemotherapeutic~     regimens represented by several genotoxic agents including but not limited to~     Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the~     format of either a single agent or combinations are safe, tolerable, and effective in the~     treatment of patients with infiltrating ductal carcinoma of breast.~   "
12185|NCT02897687|"~     Twelve participants were randomized to either a Facebook group or a book club group for six~     weeks. Data was collected on the participants social and behavioral function at both the~     start and the conclusion of the intervention.~   "
12186|NCT02897674|"~     Aims: To investigate whether diet with realistic doses on palm oil will have an effect on~     lipid profile and fat deposition in healthy volunteers.~      Design: Randomized, parallel design over 14 weeks including a 2 week standardization period~     and 12 week supplementation. In the standardization period all participants will incorporate~     palm oil into their diet which will make up 20% of their calories providing a baseline~     measure. In the supplementation period of 12 weeks, each volunteer will be randomized into~     one of the three fats: palm olein, interesterified palm olein or soybean oil, consuming 20%~     of their calories from these fast and remaining 10% fat calories from fats naturally~     occurring in foods like meat and nuts. Otherwise participants will keep the rest of their~     diet habitual.~      Population: 60 healthy males and females aged between 18 and 60 years, of which 30~     participants with a BMI between 18.5-24.9kg/m2 and 30 participants with a BMI between~     25-29.9kg/m2 and fasting plasma glucose and no evidence of insulin resistance will be~     recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of~     diabetes, hypertension or hyperlipidemia.~      Treatment: Pre-intervention: Participants will be asked to record habitual dietary intake by~     completion of a 4-day food diary and be asked to wear an accelerometer armband to assess~     physical activity at the beginning and at the end of supplementation period.~      2 weeks standardization period: All participants will be asked to replace added fat in their~     diet with palm olein providing two thirds of 30% fat calories.~      At the end of the standardization period, which will be the first day of a 12 week dietary~     intervention, as well as at the end of 12 week supplementation, participants will attend the~     clinical research facility for a study visit. Weight, height and waist circumference will be~     taken; total and regional body composition will be measured by MRI. Fasting and post~     prandial plasma glucose, insulin, appetite hormones and lipids will be measured.~     Participants will be asked to come in for follow-up visits at week 6 and 10 for a single~     blood samples and weight check.~      12 week supplementation period: participants will be randomized into one of the three~     supplementation groups: palm olein, interesterified palm olein or soybean oil. Participants~     will be asked to consume two thirds of their 30%fat calories from one of the oils while~     incorporating it into their normal diet in cooking and baking.~   "
12187|NCT02897661|"~     Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to~     assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients~     with Crohns' disease.~   "
12993|NCT02887183|"~     This study is to determine early and more chronic changes in concentrations of biomarkers~     related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapyover a~     period of 12 months, and correlate these biomarker changes with cardiac remodeling~     parameters, patient-reported outcomes and cardiovascular outcomes.~   "
12188|NCT02897648|"~     The route of subcutaneous administration of drugs has become a common practice in some~     specialties (palliative care, geriatrics).~      This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by~     subcutaneous route but few clinical studies evaluating the level of scientific relevance~     justifies their use.~      The purpose of this study is to assess:~        1. / Determine that there is no difference between the subcutaneously compared to~          intravenous administration in terms of dosage and serum PK / PD of Beta lactam~          objectives in a geriatric population.~        2. / The safety and lack of toxicity of administrations subcutaneously.~      Advantages disadvantages~        -  easy Of establishment~        -  Simplicity Monitoring and manipulation~        -  Reduced Risk of infection~        -  No Risk of venous thrombosis~        -  Lower cost Simple -Technique for support at home taking~        -  Limitation Aggressive gestures~        -  multiplicity Of all possible injection sites~        -  Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL~          / 24 / site)~        -  Use Impossible for some drugs~        -  Risk Discomfort and intolerance at the injection site~      A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious~     disease specialists). Among them 97.5% reported regular use of the subcutaneous route for~     the administration of antibiotics.~      Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd~     (61.2%); the absence of marketing authorization for the subcutaneous route (34.5%); the~     absence of serum assay available (2.1%).~   "
12189|NCT02897635|"~     The purpose of this study is to develop and test a 12-month Integrative Medicine~     intervention based on Ayurvedic medicine in recent breast cancer survivors.~   "
12190|NCT02897622|"~     Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low~     quality of life. In 2014, a special unit based on case management (CM), for patients with~     SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating~     disorder is a serious illness that creates a great deal of suffering. Most patients who~     undergo specialized eating disorder treatment will be healthy, but a small percentage of the~     patients develop a SEED. SEED patient have gone through numerous of treatments and has been~     to several specialists units for years as well as they has completed many different~     therapies without getting fee from the eating disorder (ED). Due to the long term sick in ED~     the SEED patient is often alone and has difficulties to cope with everyday life situations.~     SEED patients are a vulnerable patient population with a great suffering and poverty to~     release the identity of the ED. However, no previous study is done in which patients with~     SEED themselves describe their own theory about why they are still ill and how specialized~     eating disorder care has affected them. In the ED field, there is a growing consensus that~     treatment of patients with SEED needs to be multi-professional, with a focus on improving~     the patients' social situation, minimizing medical complications, and enhancing quality of~     life and independence, rather than focusing one-sided on symptom reduction. Is case~     management a way to help the SEED patients witness a better quality of life? Besides the~     personal suffering of patients and their families, SEED is also associated with high costs~     for health care and for society in general.~   "
12191|NCT02897609|"~     3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most~     enteric infections in France including pyelonephritis and bacteraemia.~      However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is~     continuously increasing for several years. In 2012, in France, the proportion of E.~     resistant or intermediate coli categorized to C3G is 10 to 25% (EARSS data).~      Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for~     patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.~      At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.~      To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe~     antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test~     for detection of resistance to C3G.~      The Lacta ™ test could be used in this indication. This is a rapid test diagnostic~     orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic~     action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially~     marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial~     colonies in culture.~   "
12192|NCT02897596|"~     Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic~     Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of~     Grazoprevir + Elbasvir in HIV-HCV co-infected patients.~   "
12193|NCT02897583|"~     This is a single-center, prospective randomized controlled trial evaluating the safety and~     efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous~     detachment.~   "
12194|NCT02897570|"~     This study aims at assessing the effects of glucose and different types of breakfast on~     metabolic and neurofunctional responses in healthy individuals.~      Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received~     either a 50 g glucose load (control) or one of these breakfast:~      B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate~     filled sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream~     chocolate (15g). Prior and upon completion of each tolerance test, an EEG was performed to~     measure frontal P300-evoked potentials.~   "
12195|NCT02897557|"~     The purpose is to perform an early investigation on the safety and performance of an~     Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and~     gather clinical data that will be used to make improvements or modifications to the~     algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.~   "
12196|NCT02897544|"~     The purpose of this study is to develop and test a 6 month manualized Health Education~     intervention in recent breast cancer survivors.~   "
12197|NCT02897531|"~     The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after~     laparoscopic right hemicolectomy compared with that of side-to-side anastomosis. The~     investigators hypothesize that the end-to-side anastomosis may be associated with superior~     recovery compared with side-to-side anastomosis after laparoscopic right hemicolectomy under~     enhanced recovery program. The primary endpoint is the cumulative recovery rate, consisting~     of the recovery time of diet, pain, ambulation, and afebrile status.~   "
17268|NCT02831439|"~     The goal of this project is to examine the effectiveness and potential cost savings of two~     organizational interventions aimed at reducing the use of ineffective or unproven care among~     women with incident breast cancer.~   "
12198|NCT02897518|"~     The primary end point of this study is the feasibility of intubation. The secondary~     end-points are the success to intubate in the first attempt, the intubation time, the~     Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score~     and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and~     Glidescope®.~      Patients admit to the operation rooms of University of Naples Federico II and requiring~     endotracheal intubation for general anesthesia will be consecutively screened for the~     presence of predicted difficult airway according Italian guideline. According to this~     guideline, the presence of one or more of the following parameters may be considered highly~     predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm,~     mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior~     incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced~     mental-jugular distance. Patients matching more then 1 of the previous criteria stated by~     Italian guideline will be included in this case controlled study. Patients 1) without~     criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18~     years; or 4) declined consent to participate, will be excluded from this study.The primary~     end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary~     end-points were the learning curve, the intubation time, the Cormack and Lehane score view,~     and the need for maneuvers to aid the endotracheal intubation comparing different~     videolaryngoscopes available in our department. Two anesthesiologists with 10 years of~     experience in conventional endotracheal intubation and trained for video assisted intubation~     will perform the maneuvers.~   "
12199|NCT02897505|"~     Women will be recruited from the EMPOWER clinic when they present for care; they may be~     given a flyer as part of their clinic entry paperwork, or approached by a study staff member~     in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find~     out about the music workshops and the study through Sanctuary for Families staff, who will~     post flyers in their noticeboards or offices.~      This study will use a repeated measures survey design to evaluate the effect of a musical~     workshop intervention to aid in the management of mood, anxiety, and stress among women~     enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence.~     Assessment of the feasibility and acceptability of this music intervention will be carried~     out on participants as they are taught to manage stress and emotions.~   "
12200|NCT02897492|"~     Patients with chest pain may have postponed or missed diagnosis of acute coronary events due~     to relatively late detection of troponin elevation. The study will investigate a new~     diagnostic method for early detection of even minimal troponin elevation in patients~     admitted with chest pain.~   "
12201|NCT02897479|"~     This is a Phase II, open-label, multicenter study of Savolitinib administered orally once~     per day(QD) to locally advanced/metastatic PSC patients with MET Exon 14 mutation. The~     targeted population is the patients with MET Exon 14 mutation who have failed prior systemic~     therapy (ies), or are unwilling or unable to receive chemotherapy. Pathological diagnosis~     will be confirmed retrospectively by the central pathological laboratory.~   "
12202|NCT02897466|"~     Inappropriate antibiotic therapy in ventilator-associated pneumonia (VAP) is associated with~     increased mortality. The international guidelines recommend using broad spectrum~     antimicrobials especially in patients who received previous antimicrobials, with risk~     factors of muti-drug resistant (MDR) VAP or after 5 days of mechanical ventilation. Using~     broad-spectrum antibiotics for 48h until the results of conventional cultures and~     antimicrobial susceptibility testing (AST) are available, may promote the emergence of~     drug-resistant bacteria. Exposure to imipenem, as short as 1 to 3 days, is associated with a~     5-fold increase in the risk of imipenem resistance in the gut microbiota of ICU patients~     (Armand-Lefevre AAC 2013). Performing AST directly on clinical respiratory samples would~     hasten the process by at least 24h.~      The diagnostic performance of a rapid method combining mass spectrometry and direct AST~     [DAST] are previously analyzed, and compared it with the conventional method (mass~     spectrometry with conventional AST [CAST]) and its potential impact was assessed on~     antimicrobial use in 85 patients (Le DORZE M et al - Clin. Microbiol. Infect. 2015).~      The results produced by the dast were useable in 85,9% of the cases and the sensitivity and~     negative predictive values of DAST were 100% for all antibiotics tested, except gentamicin~     (97.1% [95%CI = 93.3-101] and 97.4% [93.7-101], respectively) and amikacin (88.9%~     [81.7-96.1] and 96.4% [92.1-100.7], respectively), compared with CAST. Specificity and~     positive predictive values ranged from 82.9 (74.2-91.5) to 100%, and from 86.4 (78.5−94.2)~     to 100%, respectively. If results had been reported to the clinicians, that DAST would have~     saved carbapenem prescription in 17 cases (22%) and would have allowed immediate narrow~     spectrum antimicrobials in 35/85 (41.2%) cases. But, the benefit of DAST was based on a~     simulation and should be now tested in a randomized fashion. This project is a prospective~     multicenter study. The hypothesis is that, DAST compared to CAST, would increase the number~     of adequate antimicrobial therapy within 24 hours in case of late VAP (> 5 days under~     mechanical ventilation) with Gram negative bacilli (GNB) in IC patients while sparing~     carbapenems (imipenem and meropenem). The primary objective is to determine the impact of a~     strategy using DAST on the rate of day1 adequate therapy without carbapenems in case of late~     VAP due to GNB.~   "
12203|NCT02897453|"~     This study is an opportunity to gather long term safety and efficacy information from~     patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).~   "
12204|NCT02897440|"~     A prospective cohort study to compare full repairing and partial repairing of soft tissue~     surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip~     function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty~     through an anteriorolateral approach were screened for inclusion. Patients with altered~     mental status SPMSQ <7, pathological fractures, non-walkers were excluded.~   "
12205|NCT02897427|"~     There are 2 parts in this study: pre-screening and the main clinical research study.~      The goal of the pre-screening part of this study is to learn if participant has antibodies~     against human papillomavirus (HPV) . Antibodies are created by the immune system and may~     attack foreign cells or diseased cells, such as HPV.~      The goal of the main study is to learn about the relationship between HPV and cancer risk in~     men who test positive for HPV antibodies. Researchers want to look for early methods of~     screening for certain types of cancer.~      HPV infections can lead to oropharyngeal, anal, and/or penile cancer. The goal of the entire~     study is to learn if screening for HPV can help doctors learn which participants may be at a~     higher risk for developing these types of cancer.~   "
12206|NCT02897414|"~     In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk~     evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA)~     opioid medications was necessary to support national efforts to reduce serious adverse~     outcomes resulting from opioid abuse. This study will evaluate trends before and after the~     ER/LA REMS implementation for changes in mortality rates associated with prescription~     opioids utilizing state medical examiner databases from multiple states. Databases from 2005~     through the most recent year available will be obtained.~   "
12207|NCT02897401|"~     Multicenter, national study, non-randomized , controlled, comparative with 4 independent~     groups (20 participants in each group). There are 3 experimental groups (smocker,~     nicotine replacement therapy an electronic cigarette) and 1 control group (without~     nicotine).~      The main objective of the study is to compare the level of urinary NNN in the electronic~     cigarette users versus the nicotine replacement therapy (patch) users.~   "
12208|NCT02897388|"~     To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality~     improvement program to increase breast milk feeding, and to evaluate its impact.~   "
12209|NCT02897375|"~     This phase I trial studies the side effects and best dose of palbociclib with cisplatin or~     carboplatin in treating patients with solid tumors that have spread to other places and~     usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor~     growth in patients with advanced solid tumors.~   "
12210|NCT02897362|"~     This study seeks to characterize sleep physiology in adolescents with and without Attention~     deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive~     and clinical outcomes within these groups.~   "
12211|NCT02897349|"~     To evaluate the efficacy and safety of linagliptin compared to placebo when added on to~     insulin therapy alone or in combination with metformin in Chinese patients with type 2~     diabetes mellitus with insufficient glycaemic control~   "
12212|NCT02897336|"~     An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and~     interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related~     sciatica.~   "
12213|NCT02897323|"~     The incidence of congenital heart disease is about 8 per thousand live births. Thanks to~     advances in cardiac surgery, 90% of children born with heart defects reach adolescence and~     adulthood. Congenital heart defects are the leading cause of heart disease in young adults~     and expectant mothers in Western countries. The number of patients increases continuously as~     life expectancy increases. An increasing number of patients with complex heart defects~     survive to adulthood. The medico-surgical management of this highly specialized growing~     number of patients is difficult and requires a multidisciplinary collaboration. In France,~     an estimated 200,000 patients the number of carrier patients with congenital heart disease.~     Half of them will require monitoring, medical procedures, catheterizations and/or surgical~     re-intervention. No objective demographic data are currently available on the French~     patients. So, the investigators decided to set up an epidemiological project to better~     understand this cohort of patients. The main objective of this project is to obtain accurate~     epidemiological data needed to adapt the supply of care.~   "
12214|NCT02897310|"~     This study assess the vital status, renal function and renal recovery of patients admitted~     to intensive care unit and requiring renal replacement therapy for acute kidney failure.~     Patient follow up is up to 3 years after ICU admission when possible.~   "
12215|NCT02897297|"~     All patients diagnosed or followed in Brest University Hospital for Philadelphia negative~     MPNs will be included in this observational study.~      MPNs recorded included: polycythemia vera (PV), essential Thrombocythemia (ET) and Primary~     Myelofibrosis (PMF).~      This is a not interventional study. Alive patients need to sign a non-opposition consent~     form.~      Patients will be followed until last news (death, change of reference centre...).~   "
12216|NCT02897284|"~     Burnout Syndrome is one of the major challenges for health systems worldwide. This study~     strives to evaluate the feasibility and effectiveness of an 8- versus 2-week~     mindfulness-based self-care program on burnout symptoms and psychological and biological~     variables.~   "
12217|NCT02897271|"~     The purpose of this study is to investigate features of patients with Eosinophilic~     Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone,~     including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic~     Colitis (EC).~   "
12218|NCT02897258|"~     The study T2HD Thrombosis and Haemorrhage in chronic hemodialysis patients is a study of~     pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis~     centers for adults Lorraine.~      The main objective is to :~      Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in~     chronic hemodialysis patients in the Lorraine region.~      The second objective is to :~      Study the impact of these practices on the survival and the occurrence of major clinical~     events, thrombotic and hemorrhagic.~   "
12219|NCT02897245|"~     Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of tyrosine~     kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories). Two other~     inhibitors of the BCR-ABL kinase are currently on the market in France, nilotinib (Tasigna®,~     Novartis Laboratories) in the first and second-line treatment and dasatinib (SPRYCEL®,~     Bristol-Myers Squibb Laboratories) in second line. Achieving a complete molecular response~     (CMR) in patients with Chronic Myeloid Leukemia (CML) treated with tyrosine kinase~     inhibitors may be currently regarded as the ultimate level of reduction of residual disease.~     The pilot Stop Imatinib study has opened the way for a french prospective study of stopping~     imatinib, the STIM study. The results of the STIM study showed that almost 60% of patients~     exhibited molecular relapse, most frequently within the first 6 months after~     discontinuation. The parameters that are statistically associated with the loss of complete~     molecular response are the Sokal score at diagnosis and the total duration of treatment with~     imatinib. Criteria to define molecular relapse in treatment free remission patients are not~     well defined and validated. The aim of the study is to validate the loss of major molecular~     response as a robust criteria for TKI resumption. The patient's population will be CML~     patients who are offered to discontinue therapy outside the STIM strial.~   "
12233|NCT02897063|"~     The purpose of this study is to learn more about the effects of midodrine and droxidopa, two~     medications used for the treatment of orthostatic hypotension (low blood pressure on~     standing), on the veins of the abdomen of patients with autonomic failure. The study will be~     conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and~     2 testing days. The total length of the study will be about 5 days. About 34 participants~     will be screened for the study.~   "
12220|NCT02897232|"~     This is a minimal risk, anonymous, convenience sample, social behavioral study using~     qualitative descriptive survey methods. It is to ascertain community member, physician,~     resident and medical student perspectives regarding Human Papillomavirus (HPV) infection,~     associated diseases and to identify barriers which prevent these groups from ensuring that~     males 9-26 receive the three-shot vaccine series to prevent HPV infection.~      The research is focused on these questions:~      Do community members understand the ease of transmission of the HPV virus in males 9-26? Do~     community members, physicians, residents and medical students have knowledge of the~     associated diseases that may occur with the HPV virus infection in males age 9-26? Do~     community members, physicians, residents and medical students know the ages in which males~     should receive the HPV vaccine three-shot series? What barriers prevent community members~     and physicians, residents and medical students from ensuring that males 9-26 receive the~     three-shot vaccine series to prevent HPV infection?~   "
12221|NCT02897219|"~     The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c~     and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once~     daily in combination with insulin for 24 weeks. This study will also assess the~     safety/efficacy of long-term treatment (52 weeks).~   "
12222|NCT02897206|"~     This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical~     trial that aims to investigate the beneficial and harmful effects of prophylactic use of~     imipenem in patients with predicted severe acute pancreatitis. All patients with first~     attack of acute pancreatitis, an onset of disease less than 72h before admission, and an~     APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.~   "
12223|NCT02897193|"~     Horizontal bone augmentation procedures are commonly used to increase bone width to allow~     the placement of dental implants or to improve aesthetics in deficient areas. Smaller~     diameter implants could be used instead in order to avoid bone augmentation procedures.~      The comparison between these two solutions will be evaluated in the trial.~   "
12224|NCT02897180|"~     The use of a supplement food like Nyaditum resae is a reliable opportunity to stop the~     progression towards active TB through the most updated knowledge of this disease:the~     induction of tolerance.~      In order to demonstrate the percentage of efficacy of this approach, different studies must~     be run to elucidate the percentage of protection in different setting all over the world.~     The strategy is to establish its efficacy through a simple clinical trial, aimed just to~     know the incidence of TB in Placebo and NR treated contacts of active TB cases.~   "
12225|NCT02897167|"~     The study of immune pathways involved in the etiopathogeny of schizophrenia would be an~     important advance to understand the mechanisms involved in the development of this disease~     and it would be a turning point in drug therapy. Until now, the mechanism of action of~     antipsychotics focused on the blockade or modulation of brain dopaminergic pathways. If~     immunological pathways responsible for neuroinflammation and neurodegeneration which involve~     alterations in different areas and brain pathways (including dopaminergic pathways) are~     discovered, investigators could develop new treatments that act on these new targets,~     allowing to delay the onset of the first psychotic episode and improve the evolution and~     impact of this disease.~   "
12226|NCT02897154|"~     The objective of this study is to compare the performance of two i-STAT Analyzers in a~     Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test~     glucose, hematocrit and sodium on capillary specimens.~   "
12227|NCT02897141|"~     The goal of this study is to facilitate the dissemination and implementation of patient~     centered outcomes research using mHealth technology to improve self-management of adverse~     symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially~     important because the US HIV epidemic continues to exact a huge toll, especially among~     Agency for Healthcare Research and Quality (AHRQ) priority populations including racial,~     ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom~     management strategies into patients' lives through the use of mHealth technologies has the~     potential to advance the effective dissemination and implementation of patient centered~     outcomes research findings.~   "
12228|NCT02897128|"~     Wound complications after sarcoma resection are frequent and potentially devastating~     problem. The burden of surgical wound complications in the lower extremity after~     preoperative external beam radiation therapy (EBRT) for soft tissue sarcoma is estimated at~     43%. A noninvasive method of predicting complications would be extremely beneficial. The aim~     of this study is to evaluate the relationship between preoperative skin oxygenation and~     wound outcomes in a multi-center prospective analysis. This information could lead to a~     change in practice regarding surgical timing and adjunctive interventions to improve wound~     healing outcomes.~   "
12229|NCT02897115|"~     A study comparing a treat-to-target (T2T) intense treatment approach in participants with~     axial spondyloarthritis (axSpA) with routine treatment (Standard of Care (SOC)) concerning a~     reduction in disease activity.~   "
12230|NCT02897102|"~     The aim of this study was to investigate the effects of a structured program, which was~     based on abacus training associated with other activities, administered as weekly group~     classes over a 7 month period in older adults.~   "
12231|NCT02897089|"~     The purpose of this study is to evaluate and compare the clinical retention of a resin-based~     fissure sealant placed with prior application of etch-and-rinse and self-etch modes of~     universal adhesives.~   "
12232|NCT02897076|"~     Extensive animal studies have indicated that antenatal betamethasone exposure results in~     altered developmental trajectories of several fetal systems. Follow up of a randomized~     controlled trial has shown that antenatal betamethasone exposure might result in insulin~     resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have~     clearly demonstrated that betamethasone-induced growth alterations were dose-related.~      In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung~     function, similar to those obtained after a full dose.~      Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the~     potential long term effects of this drug, is not inferior to a full dose to promote fetal~     lung maturation in Humans.~   "
12270|NCT02896582|"~     This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront~     obinutuzumab in mantle cell lymphoma patients treated by~     Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus~     obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance~   "
12234|NCT02897050|"~     This multi-center, open-label, phase II randomized controlled trial is to evaluate the~     efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX)~     followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as~     neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to~     study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC~     patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging~     are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC~     (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point~     is pathological complete response (pCR) rate, and the secondary end points include: clinical~     response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in~     the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T~     helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor~     microenvironmental immune cytokines. Once there is a significant statistical difference in~     terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall~     survival (OS) will be included in the secondary end points. The aims of this study are to~     determine whether the neoadjuvant T combined with metronomic CX followed by FEC can~     significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the~     anti-tumor immune effect of metronomic neoadjuvant chemotherapy.~   "
12235|NCT02897037|"~     The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI~     patients with DES.~      This is a prospective, randomized, single-blind, active drug controlled multicenter clinical~     research and the study would enrolled a total of 380 AMI patients undergoing percutaneous~     coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or~     unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.~   "
12236|NCT02897024|"~     The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy~     treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High~     intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks.~     In comparison, usual weekly is considered standard of care; although both dosing models are~     used clinically for children with CP.~   "
12237|NCT02897011|"~     To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves~     the vaccination response to a seasonal influenza.~   "
12238|NCT02896998|"~     The objective of this trial is to demonstrate that the functional outcome of 'removal on~     demand' of the syndesmotic screw is non-inferior compared to routine removal of the~     syndesmotic screw in patients with an ankle fracture.~   "
12239|NCT02896985|"~     This is a multi-center study that explores the relationship between recapture of response~     with escalation to weekly adalimumab and trough adalimumab concentration before escalation~     in patients experiencing lack of response (LOR).~   "
12240|NCT02896972|"~     To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap~     technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to~     demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using~     swept-source optical coherence tomography (OCT)~   "
12241|NCT02896959|"~     Postoperative surgical pain has been extensively study with regard to anaesthesia pain~     modalities, however little is published with regards to various arthroscopic shoulder~     surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various~     arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive~     water retention from the arthroscopic pump could causes excessive tissue pressure and~     swelling resulting in post operative pain. Unfortunately we could not find any literature in~     the English language regarding varying pressure pump settings on post operative pain~     control. For that reason we would like to assess how variable pump pressure effect tissue~     pressure over pre set time points, and how this may relate to post operative pain control.~   "
12242|NCT02896946|"~     The detection of small liver metastases represents a major challenge during the staging~     process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT~     represents the established imaging modality for selecting patients with pancreatic~     adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of~     patients undergoing a surgical procedure are finally found to have an unresectable disease~     because of arterial involvement, peritoneal carcinomatosis, or the existence liver~     metastasis that had not been detected by preoperative workup. Compared to CT,~     diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver~     imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be~     hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve~     the selection process of candidates for curative pancreatic resection by increasing the~     detection of LM undiagnosed by traditional preoperative work-up~   "
12243|NCT02896933|"~     35 patients with multiple sclerosis have been enrolled in a previous study to record and~     analyze gait parameters.~      This study aims to enroll gender and and matched healthy subjects for a control group, to~     compare patients' gait parameters with healthy subjects'.~   "
12244|NCT02896920|"~     This study assesses Humira's® real-life effectiveness in the management of dermatological~     manifestations of moderate to severe Hidradenitis Suppurativa (HS).~   "
12245|NCT02896907|"~     This pilot clinical trial studies the side effects of ascorbic acid and combination~     chemotherapy in treating patients with pancreatic cancer that has spread to other places in~     the body, has come back, or cannot be removed by surgery. Nutrients found in food and~     dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy~     regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic~     acid and combination chemotherapy may work better in treating patients with pancreatic~     cancer.~   "
12246|NCT02896894|"~     This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW)~     online community and its implementation in 3 hospital/health system sites across Ontario.~     The 6 month study includes 1000 participants that are randomized to an immediate treatment~     group or a delayed treatment group. The primary outcome includes a change in total and~     subscale scores on the Recovery Assessment Scale. Qualitative interviews with various~     stakeholders will explore issues relating to successful implementation.~   "
12247|NCT02896881|"~     In previous studies exploring specific sequences of MRI (susceptibility weighted imaging~     (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility~     of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging~     (static or dynamic).~      This prospective study aims to compare multisequence MRI to brain arteriography imaging in~     patients undergoing brain arteriovenous malformations embolization.~   "
12248|NCT02896868|"~     The main purpose of this study is to investigate the safety and tolerability of the study~     drug known as LY3041658 in participants with certain types of skin diseases. The study will~     measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127~     days for each participant, not including screening. This study is for research purposes~     only, and is not intended to treat any medical condition.~   "
12249|NCT02896855|"~     This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in~     China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared~     with placebo + trastuzumab + docetaxel in participants with previously untreated~     HER2-positive MBC.~   "
12250|NCT02896842|"~     Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line~     therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic~     responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose~     is not yet determined and randomized studies addressing this question are on-going. First~     results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for~     patients treated with imatinib high dose. Recent studies revealed that initial Imatinib~     plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a~     dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses~     (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).~      Results from the study of Larson et al. indicate that around 40% of the patients had a~     trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major~     molecular response rate at 12 months for the patients with the lower plasmatic through level~     is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.~      Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic~     level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will~     be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort~     1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000~     ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough~     plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and~     cohort 2 and every three months in cohort 3. The first endpoint of the study will be the~     rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the~     12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to~     40% of MMR at 12 months.~   "
12251|NCT02896829|"~     It's an observational study based on 98 patients included in the STIM trial to extend the~     monitoring of patients and to have molecular and clinical data, with long follow up. Are~     there late relapses? What has become patients who relapsed during STIM trial and restarted~     TKI (inhibitor tyrosine kinase) treatment?~   "
12252|NCT02896816|"~     Study Purpose:~      Parkinson's disease leads to severally impaired motor control. The purpose of this study is~     to better understand and analyze the characteristics of arm muscle activity while doing some~     reaching tasks and of leg muscles while walking. This will allow the investigators to~     improve understanding of the mechanisms underlying the motor impairments in Parkinson's~     disease.~   "
12253|NCT02896803|"~     Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for~     infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or~     hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil~     bolus and oxaliplatin). The primary endpoint is to assess the objective response rate~     according to RECIST criteria (version 1.1) and the secondary endpoints are time until~     clinical or radiological progression, overall survival, toxicity profile.~   "
12254|NCT02896790|"~     The use of oral targeted therapies draws new medical management but also new practices for~     the patients (compliance), their family and the healthcare professionals [1,2]. These~     therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the~     patient to learn to manage. This situation underlines the importance of a therapeutic~     education to accompany this learning [3]. Nevertheless, in France, the therapeutic~     educational programs, built according to the standards of the therapeutic education (TE),~     are still very rare in cancer research [4]. In May 2012, a therapeutic educational program~     for these patients has been developed in the oncology department of the Teaching Hospital of~     Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal~     cancer patients treated by oral targeted therapies, becomes here an object of research:~     MODAP (action-research).~   "
12255|NCT02896777|"~     The culturing human embryo in vitro is a process of myriad contributing elements. From these~     factors is the pH of embryo culture media, which is crucial for embryo development. The~     investigators plan to examine three different pH values of the culture media on the live~     birth rate of in vitro cultured human embryos.~   "
12256|NCT02896764|"~     Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays~     are divergent, forming a cone.~      As a result, this technique is less irradiating that the scanner. The purpose of this~     exploratory study is to compare the performance of the scanner and the cone beam in the~     detection of anatomical structures of the ear.~   "
12257|NCT02896751|"~     This is a small pilot study to look at the feasibility of creating a customized sleep mask~     for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for~     sleep apnea. The participant will have three dimensional (3D) pictures of the face taken by~     special cameras. The pictures will be sent to a 3D printer and a mask will be created based~     on the participant's face contours. The participant will use the mask for about 6 months.~     The study will measure the amount it is used during sleep and if there is an increase in~     reported comfort.~   "
12258|NCT02896738|"~     This pilot study aims to assess the interest to add an auditory pathway morphological~     analysis during the MRI exploration of visual pathway in visually impaired children.~   "
12259|NCT02896725|"~     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,~     lifestyles and activity, especially in older patients. Compression bandaging is the main~     treatment but there are few added treatments for patients with slow healing VLU. About 50%~     of patients with VLU may be slow healing. Research suggests using keratin dressings as well~     as using compression may help healing in patients with show healing VLU, but the current~     evidence is not enough to change clinical practice. The investigators will conduct a~     randomised controlled trial to test whether using keratin dressings is better than usual~     care for slow healing VLU.~   "
12271|NCT02896569|"~     The purpose of this study is to compare the tolerability of the application of a combination~     of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and~     cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional~     radiofrequency treatment using the Venus Viva versus standard of care.~   "
12260|NCT02896712|"~     First, the investigators will determine whether Acceptance and Commitment Therapy in~     combination with Contingency Management increases initial treatment response rates.~      Second, for patients who do not respond to initial treatment, the investigators will examine~     whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.~      Third, for patients who respond to initial treatment, the investigators will assess the~     relative benefit of continued treatment with Acceptance and Commitment Therapy in~     combination with Contingency Management, as compared to Drug Counseling in combination with~     Contingency Management, to prevent relapse.~   "
12261|NCT02896699|"~     This study will evaluate the feasibility of a network intervention to train individuals to~     disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in~     their social networks.~   "
12262|NCT02896686|"~     The aim of the present study is to determine the efficacy of the placement of an onlay mesh~     to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal~     resection for cancer~   "
12263|NCT02896673|"~     Acute respiratory distress syndrome remains a serious condition, with a mortality rate of~     between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by~     limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to~     reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and~     pulmonary lesions induced by mechanical ventilation. It is therefore now established that~     the respirator settings influence patient prognosis. However, around 30% of patients with~     ARDS ventilated with these settings supposedly protective continue to present signs of~     pulmonary hyperinflation on tomodensitometry, suggesting an additional reduction in the~     tidal volume could be required in certain patients. Electrical impedance tomography (EIT) is~     a new imaging technique that gathers functional pulmonary information at bedside.~      This technique also allows a regional analysis, allowing the complexity of the spatial~     distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a~     reliable method to detect at-risk situations of lesions induced by mechanical ventilation~     among patients with ARDS.~   "
12264|NCT02896660|"~     HITLAB will conduct a crossover study wherein participants will be asked to wear an~     actigraphy device continuously for 12 weeks. The first four weeks of the study participants~     will continue their previously scheduled treatment regimen, prior to receiving the~     Probuphine implant. Following four weeks of activity and sleep baseline monitoring using the~     actigraphy device, the participant will receive the Probuphine implant as part of their~     regularly scheduled treatment plan. Observation of the participant's activity levels will~     continue for eight weeks following implantation of Probuphine. Actigraphy measurements will~     include total time asleep, total time awake, sleep efficiency, and time mobile.~   "
12265|NCT02896647|"~     This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation~     (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity~     of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of~     neuraxis inflammatory diseases.~   "
12266|NCT02896634|"~     Dried Blood Spot or DBS is a collection of blood capillary drops spotted and dried on to a~     filter paper used for different bioanalysis. In comparison to conventional blood testing,~     DBS offers practical, analytical, clinical and financial advantages. This less invasive~     sampling is already used in infectious diseases screening and is useful for persons with~     poor venous (babies, drug users or elderly). Mass-spectrometry-based analyses allow protein~     quantification on very low amount of blood sample. In the project we combine the two~     approaches to measure on DBS blood proteins with clinical relevance -including many FDA~     approves biomarkers). The detection of the relevant clinical analytes will be validated on~     available patient samples in accordance with the clinical norm ISO15189 and the requirement~     for CE IVD marking. This will allow commercial developments (kits, protocols...) realized~     with the industrial partner Spot-to-lab~   "
12267|NCT02896621|"~     The investigators investigated diastolic function among patients with obstructive sleep~     apnea (OSA) and hypertension stage I. In this randomized controlled trial, participants were~     randomly allocated to one of two groups: chlorthalidone associated with amiloride or~     amlodipine. Randomization was carried out prior to the start of the trial by an~     epidemiologist out of clinic and the randomization list was stratified by gender and~     severity of OSA. The research team and participants were blinded to the randomization list~     and allocation concealment was implemented. This trial aimed to detect changes in the~     echocardiography parameters with the drug treatment (higher in the intervention than in the~     placebo group). The investigators also assess change in daytime sleepiness among~     participants who already have been diagnosed with OSA.~   "
12268|NCT02896608|"~     This study addresses the changes in the axonal excitability parameters. It will compare~     these changes in patients with early infantile epileptic encephalopathy with HCN1 channel~     mutation and in control patients, with and without epilepsy.~   "
12269|NCT02896595|"~     In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation~     (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical~     outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of~     concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can~     be managed with intravenous sedation or General Anesthesia (GA). Within this setting,~     General anesthesia is associated with improved procedure time and cure rate compared to~     sedation.~      Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an~     endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical~     populations to decrease procedure and recovery time, improve hemodynamic stability and~     reduce anesthetic requirements. It has also shown to decrease airway complications, and~     postoperative nausea/vomiting which are important factors that affect overall patient~     satisfaction.~      Although general anesthesia in electrophysiology procedures is associated with a higher cure~     rate, there have been reports of increased airway trauma.Additionally, it is believed that~     volatile anesthetics may be associated with increased ventricular action potential duration~     as well as prolonged QT interval. The increased usage of opioids during general anesthesia~     is also thought to interfere with electrophysiology studies by affecting vagal tone.~      At Virginia Commonwelath University (VCU) Health system, Anesthesiologists have been~     successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for~     over five years. The investigators plan to perform a retrospective review of all patients~     who underwent catheter ablation of PAF at Virginia Commonwealth University Health System~     from January 2014 - December 2015. The primary endpoint evaluated will be procedure time.~     Other data collected will include demographics, cardiac history, type of anesthesia, amount~     of intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total~     length of hospital stay, intra-procedure hemodynamics, intra-procedure~     ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month~     follow-up.~   "
12272|NCT02896556|"~     The purpose of this study is to evaluate the esthetic performance of resin infiltration~     technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth~   "
12274|NCT02896530|"~     Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly~     Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal~     complications. In over 60% of cases, these vascular complications of deep venous thrombosis~     (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a~     risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely~     related to disease activity.~   "
12275|NCT02896517|"~     Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most~     cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened~     for the most affected by this disease and aggravating factors population, associated~     comorbidities.~      The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.~        -  Acute renal failure and hyperkalemia are the major complications that worsen the~          prognosis.~        -  In most cases, acute renal failure is reversible. Acute renal failure caused by renal~          vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct~          cytotoxic action of myoglobin.~      If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the~     tissue damage is greatly aggravated during muscle reperfusion, creating~     ischemia-reperfusion. Reperfusion will not only cause the release into the bloodstream of~     the cell contents myocytes but also an increase in necrotic areas. Indeed, the massive~     arrival of oxygen at the myocyte will cause significant production of free radicals,~     increasing their toxic effects.~      Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation~     by bicarbonates is questionable oral alkalizing seems to be an alternative when possible~     (oral alkaline solution) but not used to this day.~      The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of~     the free radicals during reperfusion by decreasing their toxicity is still not considered~     clinically.~   "
12276|NCT02896504|"~     Some cancer patients report experiencing mild problems with thinking during or following~     chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory~     and difficulty performing complex or multi-tasks. These symptoms often soon disappear after~     treatment. However for some patients, they may persist for years and this can have a~     significant effect on their quality of life. The reasons for these symptoms are not well~     understood.~      This study proposes to examine the effects of chemotherapy on the brain and how the changes~     in the brain affect one's ability to move one's arms and fingers. By better understanding~     the negative consequences of chemotherapy on the brain and nervous system, the hope is to~     help pharmaceutical companies develop safer cancer treatment drugs.~   "
12277|NCT02896491|"~     To investigate possible effects of radio frequency electromagnetic fields on EEG activity~     during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG~     potentials, auditory evoked potentials) and cognitive performance measures in test of~     selective attention, divided attention and working memory in healthy elderly males (60 - 80~     years).~   "
12278|NCT02896478|"~     The path of a patient depends largely on his health care network, that is to say of the~     interrelationships between health professionals who will be involved throughout his career.~     At the hospital, the transition points in the care process is a vulnerable time for the~     patient regarding the continuity of his medication. These transition points are the intake,~     the transfer and the outlet. In town, our health system must be able to build on the~     inter-city hospital, warranty essential guarantee of the continuity of care. However, there~     is often a breakdown in this relationship with more or less serious consequences ranging~     from simple dissatisfaction of the patient, to the realization of duplicate examinations or~     the use unjustified emergency and re-hospitalization. Medication errors can occur, resulting~     from incomplete information or poorly communicated in this city hospital interface.~      The city hospital dysfunctions are mainly organizational, hospital being rather specialized~     therapeutic approach centered on pathology and medicine city instead focuses on a patient's~     overall approach.~      The involvement of the pharmacist in the hospital, as the city is an interesting axis to~     develop. In town, the pharmaceutical nomadism, including in major cities remains low,~     patients generally have a dedicated pharmacies for the treatment of their serious or chronic~     pathologies. The development of the pharmaceutical dossier today allows the pharmacies to~     access the history and the entire therapy of patients prescribed to town by different~     specialists and general practitioners, on the last 4 months. Its recent availability within~     our hospital Group allows us to consider its use to fully optimize the patient's drug~     monitoring.~   "
12279|NCT02896465|"~     Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute~     diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients~     hospitalized with acute diarrhoea.~   "
12280|NCT02896452|"~     The investigators have documented a genetic predisposition for some astronauts to develop~     ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women~     with polycystic ovary syndrome (PCOS) have several characteristics similar to those~     described in astronauts, including: higher homocysteine concentrations, increased incidence~     of intracranial hypertension, increased retinal nerve fiber layer thickness, increased~     incidence of white matter hyperintensities on MRI, increased androgen concentrations (or~     androgen responses to space flight), and indices of altered carbohydrate metabolism. Women~     with PCOS have not been evaluated in detail regarding the occurrence of other anomalies~     observed in astronauts including choroidal folds, optic disc edema and cotton wool spots as~     well as changes in cycloplegic refraction, and optic nerve sheath diameter. While~     researchers have evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial~     studies show an association with certain one-carbon polymorphisms, none have looked at the~     complete set of SNPs proposed here. This study will evaluate women with PCOS and/or~     idiopathic intracranial hypertension (IIH) to assess one-carbon biochemistry and genetics~     and their possible correlation with ophthalmologic findings. The investigators aim to~     clarify the relationship of one carbon metabolism and ophthalmic findings in astronauts and~     patients with PCOS and/or IIH.~   "
12381|NCT02895269|"~     COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis~     implemented by complementary alternative providers (traditional and faith healers) and~     conventional primary health care providers (PHCP) is compared with care as usual in which no~     formal collaboration takes place between the two groups of health providers. COSIMPO is~     therefore a test of a complex task sharing approach for the care of patients with severe~     mental disorders.~   "
12281|NCT02896439|"~     Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic~     injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported~     a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also~     providers of neurological complications with rates, significant, have recently been~     precisely detailed by a cohort study published by Lehmann et al. (2): In a series of 2073~     patients, the authors reported an overall complication rate of neurological related to the~     initial trauma of the order of 4%. In this series, 1395 patients were operated with a rate~     of iatrogenic neurological complications of 2 to 3%. Regarding the first routes (and~     therefore the types of fractures), the Kocher-Langenbeck path is the path that leads to the~     greatest number of neurological complications: 3 to 4% in this series (2). However, this~     cohort study does not specify what truncal achievement it is. Obviously violations posterior~     acetabular are preferentially providers of sciatic injury while violations prior acetabular~     are more providers of obturator or femoral lesions. But this is not always the case.~     Moreover, this study does not specify the type or severity of neurological involvement.~   "
12282|NCT02896426|"~     The main objectives of this study are to evaluate the feasibility, acceptability, and~     effects of a CPS parent group on outcomes for a sample of parents of children ages 3 to 5~     compared to outcomes after attending a parenting group that promotes behavioral (operant)~     parenting. We hypothesize that guardians in the CPS group will report a better understanding~     of how neurocognitive skills relate to children's behaviors, greater improvements in child~     functioning and behavior, and greater reductions in parents' stress than those in the~     comparison group.~   "
12283|NCT02896413|"~     Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer~     patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.~     Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study~     investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes~     in patients undergoing uterine cancer resection.~   "
12284|NCT02896400|"~     The investigators propose an innovative full-factorial design in a cohort of 1056 adult~     smokers in an urban emergency department (ED), to test the efficacy of four key intervention~     components: motivational interviewing, medication, quitline referral, and texting. At the~     trial's completion, a mixed-methods approach will be used to identify the components that~     were efficacious within the proposed cost constraint, along with feasibility and~     acceptability to providers and subjects. The investigators will then assemble an~     intervention that maximizes efficacy, given a cost-effectiveness constraint and findings~     from a qualitative analysis.~   "
12285|NCT02896387|"~     Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic~     abnormalities, primarily affects the skin and cornea. The most common forms are called~     Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and~     Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic~     treatment, no cure is available. To understand the molecular defects associated with this~     disease and to identify therapeutic tools, a research team modelized the disease by~     reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced~     iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and~     demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in~     patients.~      P63 gene belongs to the family of p53 gene. The functions of the two proteins are very~     similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in~     patients and thus alleviate skin defect healing and limbic regeneration.~   "
12286|NCT02896374|"~     Case-control comparison of clinical population, interventional and single-center research.~   "
12287|NCT02896361|"~     This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing~     stimulation paradigms in patients with chronic pain.~   "
12288|NCT02896348|"~     The goal of this study is to explore if the SynPhNe system can be used without difficulties~     in the home setting for upper extremity rehabilitation therapy for people who suffered a~     stroke.~   "
12289|NCT02896335|"~     This research study is studying palbociclib as a possible treatment for recurrent brain~     metastases.~      - Pfizer, a pharmaceutical company, is supporting this research study by providing the study~     drug as well as funding for research activities~   "
12290|NCT02896322|"~     Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative~     approach for early breast cancer after conservative surgery, for addressing the need of a~     radiotherapy target only to the surgical cavity in selected patients, exceeding the limits~     of other PBI/APBI.~   "
12291|NCT02896309|"~     This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal~     renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney~     disease. This treatment is compared to sodium chloride treatment, which serves as control~     for increased sodium-intake and no treatment, which serves as time-control.~   "
12292|NCT02896296|"~     Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who~     complete the RB-US-13-0003 study and for whom a new treatment venue has not been identified.~   "
12293|NCT02896283|"~     The aim of this randomized split-mouth design clinical trial is to clinically evaluate the~     effectiveness of diode laser in the healing of donor site of palate in free gingival graft.~   "
12294|NCT02896270|"~     The trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients~     with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change~     disease (MCD).~      VPA used as an add-on to steroids might induce clinical remission in a first category of~     patients and potentially reduce the dose of maintenance immunosuppression required to~     maintain remission thereafter.~      In a second category of patients VPA might allow the reduction or even cessation of~     immunosuppression while clinical remission is maintained.~   "
12295|NCT02896257|"~     This Quality Enhancement Research Initiative (QuERI) is designed to determine efficacy and~     acceptance of an intervention method to provide primary care providers with patient-tailored~     electronic consults and corresponding unsigned orders for de-implementation of inhaled~     corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.~   "
13574|NCT02879734|"~     The purpose of this study is to compare function of the peritoneal dialysis catheter in two~     groups of patients with and without prophylactic omentopexy that was performed during~     laparoscopic insertion of peritoneal catheters.~   "
12296|NCT02896244|"~     During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota~     (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the~     occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile~     infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number~     and severity of CDI are considered as worldwide public health threats.~      Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device~     in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to~     carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of~     antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and~     treated with predefined antibiotic classes known to increase the risk of CDI. The incidence~     of CDI in this population is unknown, yet, incidence is an important determinant for the~     required sample size.~      Therefore, the main objective of the current study is to assess CDI incidence in patients~     ≥50 years of age treated with predefined antibiotic classes.~      In addition, to optimise the target population of the DAV132 RCT, the effect of the~     predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore,~     biomarkers predictive of CDI occurrence might help identify patients at high risk for the~     disease, which could further optimise the RCT. No validated biomarkers have been described~     in the literature yet. Assessment of potential biomarkers is another aim of the present~     study.~   "
12297|NCT02896231|"~     This phase I, first-in-human dose-escalation study was conducted to determine the maximum~     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),~     pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.~   "
12298|NCT02896218|"~     Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment~     of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus~     (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin~     concentration in clinical practice, especially in the critically ill patients. So far, few~     studies have investigated the clinical outcomes of the dosage strategy that vancomycin~     dosage is administered and adjusted individually using PPK and Bayesian methods based on~     observed concentrations. The objective of this study is to investigate the effectiveness,~     safety and economics of the vancomycin individualized dosing service provided by~     pharmacists.~   "
12299|NCT02896205|"~     Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD.~     Lung involvement is the most common cause of death in these patients. The present study is~     performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD~     in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared~     with that of oral placebo.~   "
12300|NCT02896192|"~     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight and~     other factors in patients with pro-opiomelanocortin (POMC) deficiency obesity due to rare~     bi-allelic loss-of function POMC or PCSK1 genetic mutations.~   "
12301|NCT02896179|"~     Multiple Sclerosis (MS), the most common non-traumatic cause of neurologic disability in~     young adults, affects mobility and ambulation in the majority of patients. Nearly 50% of~     persons with MS will require an assistive device to ambulate within 10 years of diagnosis. A~     subgroup of MS is Primary Progressive MS, which manifests with gait disturbances over 80% of~     patients in the long term. In addition to altered gait, nearly 70% of patients will~     experience cognitive deficits during the course of the disease. Therefore, actions that~     facilitate patient involvement in finding solutions for personalized management of disease~     and disability are needed.~      Although immunomodulatory drugs offer some benefit in other types of Multiple Sclerosis,~     there is currently no effective treatment for Primary Progressive MS. A fundamental goal in~     the management of persons with MS is to maximize their ability to ambulate and perform safe~     and effective transfers in everyday life.~      In the last decade, research has increasingly centered on the effects of robot devices in~     the rehabilitation of patients with neurological diseases. This has led to the development~     of new robot-assisted gait devices engendered by virtual-reality systems, and several~     studies have demonstrated the positive effects that these devices have on gait endurance and~     quality of life in patients with neurological diseases and disability.~      The aim of this project is to develop and study the effects of a novel, cognitively~     intensive virtual-reality -based rehabilitation software application that simulates a~     real-world environment where a person can walk. The virtual-reality application is an~     upgrade version synchronized to a robotic device, the GEO System. The second aim is to~     compare the cognitive and motor effects of robot-assisted gait training with this~     application against training with robot-assisted gait training without virtual reality.~      The experimental group will receive robot-assisted gait training with the virtual-reality~     application and the control group will receive robot-assisted gait training All subjects~     will undergo training for 6 weeks (2 sessions/week) for a total of 12 sessions. Assessments~     before training, after training, and at follow-up will be performed using clinical and~     instrumental tests to compare the effects of training.~      Successful completion of the study may help patients to alleviate the impact of disability,~     increase their independence in activities of daily life, and improve their quality of life.~     Through new rehabilitative strategies that combine cognitive and motor training involving~     higher brain functions and motivation, patients will be stimulated to walk in a~     reality-based environment.~   "
12302|NCT02896166|"~     Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung~     cancer accounts for 85%. Only part of patients could be treated with radical surgery, and~     some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse~     surgery. For those patients, microwave ablation (MWA) could be an alternative treatment.~     Several small sample retrospective studies verified that MWA could be an efficacy and safe~     treatment.~   "
12303|NCT02896153|"~     In France, consumption of hypnotic drugs is high. In this context, and given the planned~     regulatory modifications, it seems essential to make an inventory of the consumption of~     drugs taken for a hypnotic purpose. This study aims to identify the substances (medical or~     not) used for a hypnotic purpose in the adult population going to a pharmacy.~   "
12304|NCT02896140|"~     The aim of this study is to determine the relationship between the percentage of calories~     from dairy intake and long-term glycemic control and weight maintenance in patients with~     type 2 diabetes who participate in an intensive lifestyle intervention program.~      The investigators hypothesize that overweight and obese patients with type 2 diabetes who~     consume higher percentage of calories from dairy products during intensive lifestyle~     intervention programs have better glycemic control and maintenance of weight loss as~     compared to those who consume lower percentage of calories from dairy products.~   "
12305|NCT02896127|"~     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to~     placebo in patients with ankylosing spondylitis at Week 16 and long term efficacy and safety~     up to Week 52.~   "
12306|NCT02896114|"~     The study aims to evaluate the current methods of surgical treatment for Congenital~     Pseudarthrosis of tibia(CPT) in children and their results respectively.~   "
12307|NCT02896101|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study~     to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark~     Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant~     Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis~     (AD).~   "
12308|NCT02896088|"~     Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and~     its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in~     temporary dentition could slow the specific development of carious lesions in early~     childhood. In addition, this non-invasive approach could delay the conventional food and~     thus save financial costs for more complex treatments. Finally, the installation of AS could~     afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged~     in the caries process.~   "
12309|NCT02896075|"~     The purpose of this study is first to investigate the effect of a controlled intervention~     with a comedy video on pain tolerance in a social setting while quantitatively measuring~     laughter in a young healthy population experiencing delayed onset muscle soreness. The~     comedy intervention will be compared to a control of watching a documentary. The second aim~     is to examine to what extent various methods of eliciting pain would cause physiological~     responses that confound the interpretation of a pain stimulus.~   "
12310|NCT02896062|"~     In the present study, a 4-week sleep coaching program is developed and evaluated in members~     of the German armed Forces. The aim of the program is to provide an efficient tool to~     prevent sleep disorders, and to improve mild sleep disorders, with a special focus on~     insomnia.~   "
12311|NCT02896049|"~     Based on the basic data of all patients foreseen for a local hyperthermia in the~     participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the~     complication rate (injury to the patients) will be recorded.~   "
12312|NCT02896036|"~     Purpose: The primary objective is to compare the time required for adequate intraperitoneal~     insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the~     number of attempts needed before successful entry is achieved. The secondary objectives will~     evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal~     insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and~     omental injury between the two techniques.~      Study design: prospective randomized control trial~      Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery~     for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress~     needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg~     of intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2~     insufflation, and will require less number of attempts to achieve successful entry.~   "
12313|NCT02896023|"~     Patients will be subjected to:~      A. Clinical evaluation including history and examination~      B. Ultrasonographic evaluation of Ovarian Morphometry:~        -  Patients will be evaluated in early follicular phase of the menstrual flow (cycle's~          days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China,~          by only one examiner to avoid inter-observer variations.~        -  Ovarian images will be procured in the sagittal and coronal planes and the frozen image~          reflecting the largest ovarian dimensions will be utilized for the measurement of~          ovarian length, width, and height (cm) as per standard clinical practice. Mean values~          of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume~          formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height~          (D3) × 0 .523}~        -  Antral follicle count will be determined for each patient~      C. Laboratory Evaluation:~      Blood samples will be collected in the early follicular phase. Samples will be immediately~     centrifuged and serum saved at -20 degrees for measurement of:~        -  Anti Mullerian Hormone (AMH)~        -  Follicle Stimulating Hormone (FSH)~        -  Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)~   "
12314|NCT02896010|"~     Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed~     to promote adherence to physical activity guidelines for people with prediabetes.~   "
12315|NCT02895997|"~     The purpose of the study is to determine if temporarily relocating clinicians who deliver~     remote care using the eICU telehealth system to Sydney, Australia will lead to greater job~     satisfaction, reduced physiologic stress, and improve performance. Four nurses and six~     physicians will be sent to a site in Sydney Australia on a rotating basis to determine~     whether providing care during the Australian daytime is more efficient and precise than~     providing care during the night in the United States.~   "
12316|NCT02895984|"~     Alcohol use is almost ubiquitous on college campuses and first-year students are at~     particularly high risk of alcohol-related harm when they first make the transition to~     college. Peers are important agents in socializing both healthy and unhealthy behaviors, but~     despite the clear role of peer behavior in the maintenance of college problem drinking,~     there have been no efforts to measure the effect of individual change on the reduction of~     alcohol-related risks in the broader student body. That is, despite the importance of social~     connections for inducing and maintaining alcohol use in youth, intervention approaches have~     not measured nor capitalized on the potential of social influences for changing this problem~     behavior. It is essential that we understand the indirect effects of individual~     interventions and the impact such interventions have on the social structure and social~     connections. The best way to evaluate such effects is to use a research design that~     experimentally manipulates drinking using the best available intervention and measures its~     effects on the social network and its members.~      The purpose of this research is to investigate whether using an established individual Brief~     Motivational Intervention (BMI) administered to a small number of influential network~     members embedded in a social network significantly reduces heavy drinking and alcohol~     consequences among close peers who do not receive any intervention (the investigators call~     this the indirect intervention effect). In addition, the investigators will investigate~     putative social influence mechanisms of this transmitted effect, investigate how specific~     types of network connections and relationships moderate the indirect intervention effect,~     and investigate the effects of the intervention on network position and structure.~     First-year students at Brown (N = 1,280) will be enrolled and assessed early in their fall~     2016 academic semester. Using baseline data, dormitories (N = 10) will be matched on size~     and randomly assigned to one of two conditions: BMI or natural history control (NHC). Heavy~     drinkers in each dormitory who are in the top quartile of betweenness centrality, a social~     network construct that reflects high connectivity and potential influence, will either~     receive BMI or serve as controls, according to their dormitory's intervention assignment.~     All participants will be assessed again 5 and 12 months after baseline to measure changes in~     behavior and in peer ties in the entire network of first-year students. The long-term~     objective of this research is to understand how peer influences function in social networks~     in order to leverage those mechanisms to reduce problematic alcohol use in heavy drinking~     populations.~   "
12317|NCT02895971|"~     The aim of this study estimate VTE incidence. Investigators prospectively record all cases~     of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs~     diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.~   "
12318|NCT02895958|"~     To investigate whether Zepatier can safely and effectively be administered in a community~     based setting to stable F3/F4 fibrosis HCV patients on stable opiate substitution therapy.~   "
12319|NCT02895945|"~     The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with~     congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective~     surgical, dental, or other invasive procedures.~   "
12320|NCT02895932|"~     The purpose of this study is to determine if changes in brain serotonin affects the~     accumulation of amyloid in the brain. The investigators will use brain imaging methods to~     measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's~     Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain~     imaging to assess amyloid accumulation two years after their first brain imaging session.~     All participants will undergo examinations to assess their motor function, and asked~     questions to assess their mood and thinking.~   "
12321|NCT02895919|"~     This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab~     as compared to current culture media standard, bedside inoculation with blood culture~     bottles.~   "
12322|NCT02895906|"~     This is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17~     years with 22q11DS who have a diagnosis of anxiety disorder, and/or ADHD, and/or ASD.~     Approximately 12 subjects will be initiated, dose optimized, and maintained on NFC-1 over a~     period of 5 weeks.~   "
12323|NCT02895893|"~     The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency~     management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis~     (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, the~     app).~   "
12324|NCT02895880|"~     The purpose of this study is to collect initial data on what survivors of childhood,~     adolescent, and young adult cancer think of how information about statins is communicated.~     Statins are medications that lower cholesterol. The results of this study will be used to~     improve the communication about statins. This is to aid patients and their providers in~     making health care decisions together, also known as shared decision making.~   "
12325|NCT02895867|"~     This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate~     the effect of dairy products with full or low fat on glycemic control and cardio-metabolic~     risk factors in comparison to a regular diet.~   "
12326|NCT02895854|"~     The aim of this trial is to find out if there are any differences in the profiles of acute~     and late adverse effects among men with low and intermediate risk prostate cancer treated~     either with low dose-rate brachytherapy or hypofractionated external radiotherapy~     (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each~     treatment will be analysed.~   "
12327|NCT02895841|"~     The purpose of this study is to learn more about the ways in which mobile technology can be~     integrated into inpatient care to help better track pain levels using mobile technology of~     patients with sickle cell disease, oncology patients, and bone marrow transplant patients.~     The study will assess whether or not daily mobile monitoring with wearable accelerometers~     (devices that detect movement as well as heart-rate) to monitor and manage medical~     treatments can have a lasting positive impact on outcomes in patients with chronic diseases.~     The investigator hopes to learn more about the ways in which mobile technology can be~     integrated into inpatient care. Specifically, the investigator is looking to help patients~     better track their pain, use wearable technology to track physiological measures (for~     example, heart rate, sleep quantity and quality), and integrate these data points into the~     medical care of patients by providing the information to providers. This study will first~     gather information regarding the feasibility and acceptability of the use of technology on~     the inpatient unit. This will help the study team to refine the technology of the mobile app~     and logistics of integration. Following this, the investigator will complete a second phase~     of the study, during which select patients will pilot the intervention. This will be~     followed by the third and final phase, during which patients will be randomly assigned to~     the active intervention or standard of care. This phase approach will enable the study team~     to refine the intervention, relying on the feedback from patients and providers, and~     subsequently test its utility compared to standard of care through random assignment.~   "
12328|NCT02895828|"~     This study will compare the effects of 2 exercise programs including core stabilization~     exercise and general trunk strengthening exercise programs on trunk muscle activity,~     physical dysfunction, quality of life and lumbar motion in low back pain patient with~     clinical lumbar instability.~   "
12329|NCT02895815|"~     The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells~     administered into the subretinal space by the suprachoroidal surgical approach and the~     subretinal access kit (SRAK-02) in participants with visual acuity impairment associated~     with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).~   "
12330|NCT02895802|"~     Purpose: To assess the feasibility of using videos depicting people with DS to teach other~     adults with DS to perform healthy behaviors.~      Hypothesis: Videos of adults with DS performing healthy behaviors is a more effective way to~     promote healthy behaviors by adults with DS than other methods tested.~      This project will study whether videos showing a person with DS washing his hands correctly~     can improve hand washing by other adults with DS.~   "
12331|NCT02895789|"~     This proposal will focus on (1) estimating oxidative capacity of specific muscle groups~     during exercise using near infrared spectroscopy and (2) describing body composition to~     better understand exercise capacity and mitochondrial function in ambulatory spinal muscular~     atrophy (SMA) patients and disease controls. It is a 6-month observational study including~     14 ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14~     healthy controls.~   "
12332|NCT02895776|"~     Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke.~     Data tend to show that final neurologic outcome is superior if the thrombectomy procedure~     was performed under conscious sedation.~      The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures~     every year.~      We report a rate of 5% of these procedures requiring general anesthesia despite conscious~     sedation being the standard of care. This study aims to identify clinical factors associated~     with a risk of conversion of a conscious sedation to a general anesthesia.~   "
12382|NCT02895256|"~     Cluster headache is a syndrome characterized by disabling headache and accompanying~     autonomic symptoms. Despite cluster headache is called suicide headache, its natural~     history has not been well investigated. We aimed to investigate its disease course, overall~     prognosis, and treatment pattern in our retrospective cohort.~   "
12383|NCT02895243|"~     This pilot study will be a clinical trial to test the feasibility and effectiveness of a~     kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease~     (ESRD) who are within 3-6 months of transplantation.~   "
12333|NCT02895763|"~     A Quality work was conducted to enable the future construction of a Quality of Life~     Questionnaire Related to Health (HRQoL) in patients with slowly progressive neuromuscular~     disease (NMD) as myopathies and muscular dystrophies. The discussion group training is an~     effective method to perform a thorough investigation of aspects of HRQoL potentially altered~     by NMD. Patients were recruited in France by 4 reference centers MNMs. All verbal~     interactions between participants focus groups were recorded. A qualitative analysis of the~     transcript was performed. The transcript provided 2424 CIF categories. The results helped to~     identify and quantify aspects of life that are altered by NMDs between patients. A pool of~     64 items and a validated questionnaire (the WHOQOLBREF) were thern passed by 159 patients~     enrolled in eight reference centers MNMs. The investigators constructed a questionnaire~     called QoLNMD which is composed of two general items and 24 items classified into three~     areas: (1) \ Impact bodily symptoms, (2) \ Self-perception and (3) \ Activity~     participation. Each area has good psychometric properties (Cronbach's alpha> 0.77,~     test-retest ICC> 0.81, H Loevinger> 0.41) and met the assumptions of IRT. the comparison~     with the WHOQOL-BREF was used to assess similarities and differences with a generic~     questionnaire. The next step was to validate the QoLNMD reassessing its psychometric~     properties in a new patient sample and calibrate the IRT measurement system. The purpose of~     these new part of study was to validate the French version of the QoL-NMD on a confirmatory~     sample of patients and to calibrate its measurement system. A prospective study in 8 NMD~     referral centers (France) was conducted. Both the QoL-NMD and a validated generic~     questionnaire (the WHOQOLBREF) were administered to patients. 156 patients were included for~     the confirmatory psychometric analysis. All three domains showed adequate psychometric~     properties and met IRT assumptions. The IRT model calibration was then performed~     successfully on 315 patients. The French version of the QoL-NMD showed adequate psychometric~     properties and can be used in rehabilitation services. A conversion table enables easy~     transformation of sum scores into IRT-calibrated measures. Minimum detectable change tables~     help interpreting score change.~   "
12334|NCT02895750|"~     There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and~     there is no available data in chronic kidney disease (CKD). The planned study aims to~     provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type~     II patients.~   "
12335|NCT02895737|"~     This prospective, randomized study was designed to analyse the difference of cerebral~     embolization in patients undergoing transcatheter aortic valve implantation with~     balloon-expandable vs. self-expandable valves by using a cerebral protection system (Claret~     Sentinel™ Device).~   "
12336|NCT02895724|"~     The purpose of this study is to examine if pressurechamber treatment (HBOT) can reduce early~     stages of breast cancer related lymphedema, and to explore the mechanisms involved in the~     disease progress.~   "
12337|NCT02895711|"~     The purpose of this study is to quantify the radiation exposure from diagnostic testing and~     surgical treatment during routine endourologic procedures for symptomatic urolithiasis.~   "
12338|NCT02895698|"~     The main aim of this study is to investigate the effects of dry cupping on calf muscle~     trigger points in patients with plantar heel pain. A secondary aim is to examine the~     correlation between several outcome measures in those patients.~   "
12339|NCT02895685|"~     The investigators have planned a randomized study, examining the effect of self-directed~     training in groups vs. individual training on trainees' acquisitions of open surgical~     skills.~      Eighty participants who signed up for a pre-existing simulation-based course in basic open~     surgical skills will be randomized to practice either in pairs or individually during the~     course. Participants open surgical skills will be tested on a simulated skin model before~     and after the course. The investigators hypothesis is that dyad training will enhance~     self-directed learning in open surgical skills.~   "
12340|NCT02895672|"~     This is a real-world, pre-post observational study from an ambulatory endocrinology practice~     which will determine the effectiveness and safety of the addition of glucagon-like~     peptide-1(GLP-1) agonist therapy (weekly exenatide {Bydureon} or daily liraglutide~     {Victoza}), added to the regimens of T2DM patients who have already received a minimum of~     one year of basal insulin therapy. Specifically, the investigators hypothesize that GLP-1~     agonist therapy added to basal insulin therapy will result in statistically significant~     improved glycemic control and weight loss, with no higher risk of hypoglycemia compared to~     baseline.~   "
12341|NCT02895659|"~     Background: Currently used crystalloid solutes have a variable composition and may therefore~     influence acid-base status, intra- and extracellular water content and plasma electrolyte~     compositions and have a major impact on organ function and outcome. Despite continuing~     evaluation no superiority of one particular type of fluid has been reached so far. To the~     best of the investigators' knowledge no study in humans has ever assessed whether the type~     of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery~     has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the~     animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac~     performance~      Primary Aim: In this study the investigators want to clarify whether a balanced type~     acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with~     better hemodynamic stability and cardiac function than a lactate-buffered crystalloid~     solute.~   "
12342|NCT02895646|"~     Beta-lactam antibiotics include penicillin and cephalosporins and are among the most~     prescribed antibiotics. This category of drugs is the most involved in immediate allergic~     manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000~     treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin,~     revealed by studies in groups of different ethnical origins in the same geographical region.~     There are also some families with a high frequency of allergic reactions without identified~     Mendelian inheritance.~      The purpose of this study is to identify predictive risk factors associated to immediate~     allergic reactions against beta-lactam antibiotics with a pangenomic approach.~      A secondary purpose is to identify rare predictive factors with homozygosity mapping and~     exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.~   "
12343|NCT02895633|"~     The purpose is to compare and evaluate multiple functional imaging methods (perfusion,~     diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular~     tumors and to determine which method or which association of methods could improve non~     invasive tissue characterization.~      Secondary purposes are:~        -  to determine a possible correlation between some parameters and the histological grade~          (FNCLCC)~        -  to suggest a coherent diagnostic imaging approach for osteoarticular tumors.~      The ancillary study will enroll patients needing radiological tumor follow-up. The purpose~     is to identify tools for evaluation of tumor activity and therapeutic response before~     modification of morpho-volumetric data.~   "
12531|NCT02893189|"~     Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical~     standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels~     planned.~      Patients will be followed up regularly during the interventional phase of the study until 12~     months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually~     for years 2 and 3.~   "
12344|NCT02895620|"~     Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the~     prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR~     and is given once a week for 6 weeks. It stimulates immune responses that can destroy~     bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes~     side effects. The investigators postulate that Xpert® test might be used to demonstrate the~     presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the~     time of intravesical treatment, which could be of very significant impact in the management~     of this complex situation.Urines of BCG treated patients are rich in immune system elements~     (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with~     urinary biomarkers. This study will allow assessing the effect of the complex inflammatory~     milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder~     cancer assay.~   "
12345|NCT02895607|"~     Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries~     in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible~     for CA. Currently 71.8% of knee arthroscopy are made in this context. However~     ligamentoplasties anterior cruciate are still carried out predominantly in conventional~     hospitalization (HC) with a median of 3 to 5.5 days of stay.~      Two recent prospective studies French single-operator shows the feasibility of~     reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were~     recorded, the risks are comparable to those of a HC.~      However, this support requires a structure and a coordinated network between different~     medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor,~     physiotherapist).~      The objective of the study is to evaluate (i.e. EPP or feasibility) ACL reconstruction in~     CA in hospitals, multi-operator.~   "
12346|NCT02894879|"~     The purpose of this study is to explore effectiveness of modified chest physical therapy~     techniques using new device in pre and post-operative program in patients undergoing open~     heart surgery~   "
12347|NCT02894866|"~     The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in~     term gestation newborn infants with hypoxic-ischemic encephalopathy..~   "
12348|NCT02894853|"~     We hypothesize that an early molecular profiling, that includes both tissue and blood-bases~     analysis, for all NSCLC patients, including stage I-III, will increase diagnostic~     efficiency. When molecular profiles are available at an earlier stage of disease, more~     patients will benefit from personalized therapy once needed. This will result in both a~     better quality of life and outcome.~   "
12349|NCT02894840|"~     The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain~     per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri~     Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.~   "
12350|NCT02894827|"~     Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a~     medication and digestive tolerance are ensured, the medication can be taken a long time from~     meals to reduce its side-effects. Despite numerous studies that have investigated links~     between medication and malnutrition, none have assessed the influence of the time the drug~     is taken on the evolution of the nutritional status of elderly hospitalized persons. So as~     to identify the best nutritional criterion in hospitalized persons, a retrospective pilot~     study will be conducted in about thirty patients. Their medication will be recorded and~     their nutritional status will be evaluated using the Geriatric Nutritional Risk Index~     (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short~     form.~      This preliminary study will allow us to choose the best nutritional criterion to compare the~     impact of two strategies for taking medication (post prandial versus pre-prandial) on~     improving the nutritional status of malnourished elderly hospitalized patients taking~     multiple drugs.~   "
12351|NCT02894814|"~     The primary purpose of this study is to investigate if patient involvement in the medication~     procedures through elements of the medication system One-Stop Dispensing (use of own~     medication, placed in bedside locker, partly or self-administration of medication) and~     focused dialogue about medication can maintain or improve the patients' health literacy to~     perform the prescribed medical treatment during and after hospitalization.~      The hypothesis is, that involving the patient in the medication procedure and focused~     dialogue about the medicine during hospitalization will improve the patients' health~     literacy measured by patient adherence, patient knowledge and perceptions of safety about~     the medication. It is further expected that more time will be spent together with the~     patient, and that the new medication procedures will be cost-neutral.~   "
12352|NCT02894801|"~     Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In~     France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57%~     in men to 60% in women. About one third of patients diagnosed with CRC will develop a~     metachronous recurrence during the following years. It is of paramount importance to~     accurately identify factors associated with the increased risk of progression and death, in~     order to develop effective follow-up and treatment strategies. However, to accurately assess~     the role of patients' specific characteristics in the progression of cancer several~     methodological challenges need to be overcome.~      One difficulty, common to prognostic studies of cancer, concerns the need to separate the~     effects of prognostic factors on different clinical endpoints, such as disease recurrence vs~     recurrence-free death. Another difficulty, encountered in prognostic studies, is that the~     cause of death is not available or not accurately coded. Yet, some patients are likely to~     die of causes not related to the disease of primary interest, especially in cancers with~     longer survival and in those that affect older subjects. Until recently, the existing~     statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to~     account for (i) possibly different effects of prognostic factors on death vs recurrence, and~     (ii) unknown causes of death. However, this challenge has been addressed by the recent~     development of the Markov relative survival model (MRS) , which extends the Markov~     multi-state model to incorporate relative survival modelling. Simulations demonstrate that~     MRS is able to accurately estimate different effects of prognostic factors on the risk of~     each of several events, including separate effects on disease-specific vs other causes of~     death. To date, the MRS had not been applied in clinical or epidemiological studies.~      The aim of this study was to assess the potential advantages of the new multi-state relative~     survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To~     this end, we compared the MRS results with those obtained with two more conventional~     analyses, based on Cox's proportional hazards model, and the multi-state Markov model~     proposed by Alioum and Commenges (2001). The three models were applied to explore the impact~     of prognostic factors on cancer-specific mortality and recurrence, in a large~     population-based French registry of colorectal cancer, with up to 25 years of follow-up.~   "
12413|NCT02894723|"~     Essential Hypertension is characterized by endothelial dysfunction due to reduced nitric~     oxide (NO) bioavailability. Impairment in nitric oxide-mediated vasodilatation in human~     brachial, coronary, and renal arteries has been demonstrated in patients with essential~     hypertension. Administration of L-arginine, a NO substrate yeld controversial results.~      The purpose of the present study, double blind and matched for age, sex and body mass index~     (BMI), is to assess the efficacy of L-arginine treatment on blood pressure (BP) control and~     arterial stiffness in patients with stage1 hypertension.~   "
12353|NCT02894788|"~     Several score systems were created to stratify perioperative risk and predict mortality. The~     study rises from the needing of a rapid and simple system to identify the patient worthy of~     Postoperative Intensive Surveillance. In the first phase Authors retrospectively~     investigated on patients underwent to elective surgery searching for determining factors~     (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs~     could predict the admission in ICU of consecutive patients scheduled for elective surgery~     during a three-months period and created an index, named PoIS (Post-operative Intensive~     Surveillance), based on the results of this analysis. Authors used surgical invasiveness~     (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass~     Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the~     development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).~      The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM~     resulted coincident and better than the American Society of Anesthesiology scoring system.~   "
12354|NCT02894775|"~     Since the early 1990s, evidence-based medicine has played an increasingly important role in~     decision-making for the treatment of patients with cancer. The highest level of evidence is~     attributed to the results of randomized comparative studies, and the public health~     authorities require proof from randomized therapeutic trials before authorizing the use of~     new treatments. Patients included in therapeutic trials benefit either from the best current~     treatment (control group) or from a treatment supposed to present a better or similar~     efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a~     randomized therapeutic trial represents the optimal therapeutic strategy.In order to~     optimize the fight against cancer, French public health policies have led to the progressive~     implementation of successive nationwide Cancer Plans since 2003. One of the objectives is~     to increase the proportion of patients included in clinical research trials. Thus, the~     fraction enrolled in France has progressively increased but remained low at around 8% in~     2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a~     context of socio-economic inequalities that concern resources, residence and access to~     services, identifying factors that determine inclusion in trials will in turn highlight the~     reasons for non-inclusion.~      The aim of this study was to determine, at a population level, the influence of demographic~     characteristics and socio-economic status of patients with digestive cancer on inclusion in~     a clinical trial.~      Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer~     Registry. According to a balancing score, the 136 patients included in a clinical trial were~     matched with 272 patients who met the eligibility criteria for trials. Deprivation was~     measured by the ecological European deprivation index. A conditional multivariate logistic~     regression was performed.~   "
12355|NCT02894762|"~     This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four~     skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical~     Chemistry Analyzer.~      Analyte Principle:~      Albumin (ALB) - Dye-Binding BCG~      Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)~      Glucose (GLU) - Hexokinase, Colorimetry~      Total Protein (TP) - Biuret~   "
12356|NCT02895594|"~     Retrospective medical chart review of patients undergoing surgical repair of idiopathic~     macular hole~   "
12357|NCT02895581|"~     Retrospective medical chart review of HIV-infected patients diagnosed with progressive~     multifocal leukoencephalopathy~   "
12358|NCT02895568|"~     This study is to measure prevalence of established and candidate molecular markers of drug~     resistant malaria at Komé, Doba, Republic of Chad.~   "
12359|NCT02895555|"~     The average life expectancy in Denmark is increasing resulting in an increasing part of the~     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes~     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,~     especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa~     et al.). LSS occurs in a combination of degenerative changes in the lower back, including~     hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.~      Current treatment of LSS is varied ranging from non-operativ conservative treatment to~     operation.~      Operative intervention shows very good results according to physical ability and~     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),~     but the most optimal treatment is still debated. Nevertheless, a decompression and, if~     needed, a spinal fusion is recommented.(Ausman).~      The investigators want to se whether i-FACTOR improves clinical outcomes compared to using~     allograft in spinal fusion in the elderly, and thereby find an improved methods operating~     this diffycult patient population.~      The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR~     or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due~     to degenerative listhesis.~   "
12360|NCT02895542|"~     This study to find out more about how patients take their anticancer medications and~     challenges related to taking cancer medications.~   "
12361|NCT02895529|"~     The purpose of this study is to investigate the hypothesis that the efficacy of intravenous~     (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous~     caspofungin as empiric therapy for suspected fungal infection participants with fever and~     neutropenia.~   "
12362|NCT02895516|"~     The study is a prospective, open-label, single-arm study, to evaluate the ease of use,~     tolerability, efficacy and safety of the Vibrant Capsule administered in the home~     environment.~      One arm will be assessed: Vibrant Capsule administered twice a week.~      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 6 weeks.~      During the 2 weeks of baseline, patients will be asked to refrain from taking any medication~     or supplement to relieve their constipation.~      After 14 days the patients will return and eligibility will be re-assessed. Patients will be~     instructed to complete a simple patient eDiary each day throughout the duration of the~     study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new~     capsules. A final visit will take place at the end of the 6 week treatment period.~   "
12363|NCT02895503|"~     The purpose of this research study is to evaluate the effects of yoga (including breathing~     exercises) on the quality of life in patients, diagnosed and undergoing standard treatments~     for non-small cell lung cancer.~   "
12364|NCT02895490|"~     This randomized clinical trial studies communication training in promoting employment~     retention among cancer patients. Communication training may improve patient-employer~     communication and increase the likelihood that cancer patients will remain employed, reduce~     patients' time away from work, and increase workplace accommodations that enable patients to~     balance treatment and work.~   "
12994|NCT02887170|"~     Losing contact with adult suicide attempters in the year after the suicide attempt (SA)~     increases the risk of recurrence. The situation with adolescents is unknown. Investigators~     aimed to determine whether being lost to contact early (LCE) by clinicians is a risk factor~     of longterm SA recurrence among adolescents and the associated factors.~   "
12368|NCT02895438|"~     Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is~     difficult, often resulting in a persistence of chronical abdominal pain.~      In adults, many patients affected by IBS improve under a gluten-free diet, even in the~     absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten~     Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the~     pathophysiological mechanisms also remain elusive.~      The aim of this study is to determine if NCGS exists in children with IBS and to identify~     the clinical, serological, and histological characteristics, which could distinguish~     patients with NCGS from conventional IBS and CD patients.~      This is a prospective cohort study in a population of children affected by a moderate to~     severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks.~     Then, children who improved under GFD were randomized in two groups for a double-blind~     placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out~     period, then a placebo reintroduction, whereas the other group had the placebo first, then~     the wash-out and the gluten reintroduction.~   "
12369|NCT02895425|"~     The rein registry collects case record data from patients with end stage renal disease~     followed in French Guiana. This allows to generate incidence and rates for terminal renal~     disease, mortality rates for each territory. The regional data are pooled in order to get~     national statistics for end stage renal disease and transplantation activity in order to~     adapt prevention to the main causes of renal failure and treatment and care infrastructure.~   "
12370|NCT02895412|"~     This study is to test a new therapy for patients with acute myeloid leukaemia who are~     undergoing blood stem cell transplant. In this study, the investigators will take a small~     number of your immune cells whose normal function is to give immunity to infections and help~     to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will~     then be given to the transplant recipient after the transplant. This is a sort of immunity~     transplant. The exact purpose of this study is to investigate if these cells are safe and~     effective in patients having a transplant for AML.~   "
12371|NCT02895399|"~     Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have~     shown that populations living in remote villages in the interior of the territory have early~     sexual relations and that multiple sexual partnerships are frequent. Hence, the main~     objective of the study was to determine the prevalence of HPV in these areas, and the~     predictive factors and epidemiology of this viral infection.~      Methods - This multicentric cross sectional study aimed the population of women aged 20 to~     65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing~     to participate will be included after being informed of the study team schedule through~     radio address and key opinion leaders. The search for HPV and cytologic examinations will be~     performed for each woman. 2 samples will be taken from each woman: one sample will be sent~     to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be~     performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur~     Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with~     carcinogenesis. HPV infection will be defined by the detection of viral DNA using the~     GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping~     will use Mapinfo.~   "
12372|NCT02895386|"~     To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous~     anastomosis in the iliac region (between the iliac artery and vein) in subjects with~     hypertension.~   "
12373|NCT02895373|"~     Bleeding complications and thromboembolic complications are frequent during extracorporeal~     membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using~     prostaglandins, in this case PGE1, may reduce thromboembolic complications without~     increasing the bleeding risk. This randomized, double-blind trial aims to investigate the~     effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.~   "
12374|NCT02895360|"~     Single-agent, open-label, multi-center sequential dose escalation and expansion study of~     BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with~     advanced or recurrent solid tumors.~   "
12375|NCT02895347|"~     The goal of our project is to define the optimal learning environment and protocol for dvSS®~     simulation activities using medical students as robotic-naïve research participants.~   "
12376|NCT02895334|"~     This study will conduct an initial clinical evaluation of this support program to examine~     its impact on reducing caregiver stress, increasing confidence in daily feeding, and~     improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).~   "
12377|NCT02895321|"~     The chief aim of this study is to evaluate the difference in tooth sensitivity after having~     used a gel containing nano - hydroxyapatite and potassium nitrate~      This randomized double-blind clinical study is designed to compare the efficacy in reducing~     dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium~     nitrate (Cavex Bite & White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste~     ( Colgate, Protection Caries, Palmolive SPA ).~      Specific objectives :~      To evaluate through standardized tests the dental sensitivity before and after the~     application of toothpastes; To compare the variations of dental sensitivity test and control~     groups.~      Safety:~      determination of adverse reactions, such as increased tooth pain and changes in the oral~     mucosa after application of the materials.~   "
12378|NCT02895308|"~     The aims of this study are to experimentally investigate and compare whether motivation~     variables can predict adherence to a prescribed assignment in face-to-face and online~     interventions using a psychotherapy analogue model.~      A total of 100 participants are included in this study and randomized to either a~     face-to-face or online intervention. Participants in both groups receive a psychoeducation~     session and are given an assignment for the subsequent week.~   "
12379|NCT02895295|"~     The objective of this study is to determine whether providing Medicare beneficiaries with a~     web-based patient-centered decision tool to help them choose among prescription medication~     coverage plans improves outcomes for patients including a greater likelihood of changing a~     plan, better coverage for prescribed drugs, less decisional conflict when choosing plans,~     and greater satisfaction with the choice process relative to current practice.~   "
12380|NCT02895282|"~     The main objective is to investigate chronobiological aspects of childhood obesity studying~     the potential relationship between meal patterns and circadian rhythmicity in a~     cross-sectional sample of obese, overweight and normal weight children/adolescent.~   "
12384|NCT02895230|"~     The research focuses on the safety profile of androgen-deprivation therapy (ADT). The~     hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across~     the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT~     modalities including intermittent ADT.~      ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh~     improvements in cancer-specific outcomes against potential increased risks for~     cardiovascular diseases. The potential for harm from ADT should be more precisely defined~     according to the type of ADT. Those potential risks underscore the importance of better~     understanding benefits of ADT, especially in contexts where data are still lacking.ADT is~     also indicated in sexually deviant behavior.~   "
12385|NCT02895217|"~     Exercise training on an immersible ergocycle is becoming more popular as it appears to be~     more suitable for men and women even with poor physical activity level. Commercial tagline~     highlight beneficial effect of this activity on weight management. However there are poor~     information concerning the energy response induced by this activity. The aim of this project~     is to investigate energetic response (energy expenditure and food intake) of a single bout~     of cycling exercise in water vs on dryland in normal weight and overweight premenopausal~     women.~   "
12386|NCT02895204|"~     To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP)~     on natural killer (NK) cell activity, circulating cytokines and serum protein levels.~   "
12387|NCT02895191|"~     Compared with placebo, evaluate the effects and safety of Ulinastatin added to conventional~     treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.~   "
12388|NCT02895178|"~     The purpose of this study is to examine the effects of exercise program on health-related~     physical fitness and biomarkers among breast cancer survivors.~   "
12389|NCT02895165|"~     The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize~     care and improve knowledge around the topics of fertility preservation and pregnancy issues~     in young breast cancer patients. The program was initiated at the National Institute for~     Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it~     has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano~     Mammella (GIM) study group. It is composed of two distinctive studies, one assessing~     fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence,~     two different study protocols were developed under the umbrella of the PREFER registry.~      PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of~     young cancer patients on the fertility preservation strategies available in Italy.~     Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies~     for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian~     function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e.~     long-term survival outcomes).~      PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management~     of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children~     born after prior in utero exposure to anticancer treatments, and the long-term survival~     outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of~     breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of~     breast cancer.~   "
12390|NCT02895152|"~     In patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical~     activity levels have been shown to increase the risk of hospital admissions and shorten~     survival rates. An established process in increasing activity levels is to undergo pulmonary~     rehabilitation classes.~      The investigators wish to identify whether the use of activity monitors,which will provide~     feedback on activity levels, will increase the physical activity levels of patients with~     COPD outside of the supervised pulmonary rehabilitation sessions.~   "
12391|NCT02895139|"~     This study will assess the ability of different orthotic insole treatments to reduce~     pressure under the ball of the foot. This is important for people who have diabetes because~     their feet are at higher risk of foot problems in this area. This study will involve the~     participants wearing a a range of insoles produced by milling, handmade processes and~     additive manufacture along with normal orthotic footwear. A researcher will measure the~     pressures under the feet while the participants walk wearing the orthotic insoles.~   "
12392|NCT02895126|"~     In so-called at risk families, the child-parent attachment relationship is more difficult to~     set up and this can be a barrier to social and emotional development of young children. To~     help parents build and sustain this relationship, and to prevent child development~     disorders, many parenting programs have been created, usually with frequent home visits by~     early childhood professionals. In France, therapeutic interventions at home are little used~     and they are not evaluated.~      In Montpellier, an action of this type has been conducted since 2001 by the Conseil~     Départemental de l'Hérault in collaboration with the University Hospital of Montpellier~     including, in addition to home visits, supervision of professionals: the Appui Parental~     Program.~      Before extending this action to other areas of Herault, the Conseil Départemental de~     l'Hérault, the Abri Languedocien and the University Hospital of Montpellier are~     conducting an assessment to know the effectiveness of the program for families under care.~      This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from~     families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental~     program (experimental group) and 44 benefiting a regular support (control group).~      A paediatric examination on the basis of the Denver scale, parental questionnaires,~     questionnaires to professionals and an a video of infant-parent interactions are used. The~     data, collected at baseline and 18 months later, will be compared.~   "
12414|NCT02894710|"~     Lidocaine, local anesthetic used for more than five decades, is being intravenously~     administered aiming at managing pain in different types of surgeries with promising results.~     Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to~     the difficulty of locoregional anesthesia and high level of opioid consumption.~      This randomized study aims to compare quality of perioperative analgesia after infusion of~     intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is~     to evaluate morphine consumption during the 48 postoperative hours.~      Others purposes are evaluation of peroperative remifentanil consumption, morphine~     consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3~     to 6 months after carcinologic ENT surgery, and incidence of side effects that can be~     attributed to lidocaine infusion.~   "
12393|NCT02895113|"~     The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot~     of acquired risk factors are involved in the development and progression of the disease.~     Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of~     developing complications increases with the duration of hyperglycemia, and usually become~     apparent in the second decade of hyperglycemia. Vascular complications are further~     subdivided into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular~     (coronary artery disease, peripheral arterial disease, cerebrovascular disease). It is~     estimated that the annual decline of estimated glomerular filtration rate (eGFR) in diabetic~     adults is about 2.1-2.7 ml/min.~      While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention~     in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA~     in these patients is at physician discretion.~      ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2~     and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin,~     serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due~     to its short half-life and artifacts associated with platelet activation ex vivo.~      COX are present in the kidney in the macula densa, in the medulla and in the interstitium.~     Experimental animals models have demonstrated that COX are involved in regulation of renal~     blood flow. In particular, in a murine animal model, after the administration of COX~     inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma~     flow and eGFR, suggesting a role for Tx in the progression of renal damage However, data on~     the relationship between aspirin and renal function in humans are scarce. In a recent work~     lead on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was~     associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up.~     Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of~     aspirin and with the decrease of eGFR at follow-up.~      The aim of the study is to evaluate the decline in renal function in diabetic patients~     treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.~   "
12394|NCT02895100|"~     The main objectives of this study are to evaluate the efficacy, safety, and tolerability of~     daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).~   "
12395|NCT02895087|"~     Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus~     in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus~     has been shown to have a unique ability to hide within the human gene inside human cells and~     in tissues, remaining 'silent' and rapidly reactivate 'waking up if ART is stopped.~      There are a number of ways to measure the silent HIV reservoir, including a common~     research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an~     early marker of the HIV virus waking up. It is often used to test how well new drugs~     developed to eliminate the silent virus might work.~      This study is examining whether the diurnal variation (daily rhythm) and/or stress can~     affect CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.~   "
12396|NCT02895074|"~     To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and~     conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in~     age-related cataracts.~   "
12397|NCT02895061|"~     Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol~     treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective~     was to observe the adverse effects between these two treatment regimens.~   "
12398|NCT02895048|"~     The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients~     with heart failure.~   "
12399|NCT02895035|"~     The objective of this study is to compare the maintenance of intraoperative mydriasis during~     cataract surgery between two drugs: epinephrine, which has routinely been used for decades,~     and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients~     undergoing cataract surgery that are enrolled in the trial will randomly receive one of the~     drugs in one eye, and the other eye will receive the drug during the subsequent cataract~     surgery.~   "
12400|NCT02895022|"~     The need to resort to a midwifery course work in cesarean is a common practice. Epidural~     analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the~     cesarean decision is taken course work in practice and the recommendations are to use the~     epidural catheter in place to convert the epidural analgesia in epidural anesthesia by~     re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases~     of extreme urgency and cons-indications for regional anesthesia as a purveyor of high~     maternal morbidity and mortality.~      The initial assumption is that the 2% lidocaine with epinephrine is the optimal and~     recommended local anesthetic solution.~   "
12401|NCT02895009|"~     The purpose of the study is to investigate the protective effects of short term TR Band~     compression on transradial coronary occlusion after transradial coronary intervention.~   "
12402|NCT02894996|"~     To predict fluid responsiveness in anesthetized pediatric patient is not an easy task~     although anesthesia provider has to deal with this question on their daily practices. Today,~     very few parameters can help anesthesia provider to predict fluid responsiveness in the~     pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge~     with high volume of fluid boluses to see if patient were fluid responsive or not. This could~     lead to fluid overload and it's associated morbidity. We would like to investigate if the~     cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be~     predictive of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective~     pediatric anesthetized patients.~   "
12403|NCT02894983|"~     There is no consensus about the best conservative treatment for patients with dorsally~     displaced distal radius fractures. The previous studies that have examined the most valid~     method for cast immobilization have lacked uniform and patient-rated outcome measures,~     proper randomization and sufficient study population. The aim of this study is to compare~     functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius~     fractures in patients aged 65 years or older. The conservative treatment is performed in~     clinical practice by various health care professionals with different techniques of~     reduction which are not limited to any specific technique in this pragmatic, randomized~     controlled trial.~   "
12404|NCT02894970|"~     To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults~     children and neonates and to compare normal controls to premature newborns suffering from~     patent ductus arteriosus and neonates suffering from pulmonary hypertension.~   "
12415|NCT02894697|"~     Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would~     increase the risk of adverse events including late stent thrombosis. OCT-guidance may~     improve more optimized scaffold placement and also better outcomes. However, there is still~     no sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it~     should be more evaluated in real practice. In the study, the investigators will evaluate an~     incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.~   "
12405|NCT02894957|"~     Rationale: No studies have examined the effect of varenicline for gradual smoking~     cessation in COPD smokers currently not interested in quitting.~      Objective: To compare the efficiency of varenicline-assisted gradual vs. abrupt smoking~     cessation in low-motivated COPD smokers~      Setting: Pulmonary outpatient clinic~      Design: Open, randomized pilot smoking cessation trial~      Participants: COPD smokers with low motivation to quit. Such low motivation will be defined~     as a score of ≤ 3 points observed in a 10 cm visual analog scale (0=non motivated; 10=highly~     motivated).~      Interventions/procedures: Patients will be randomized either to receive varenicline~     (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks~     before quitting. After quit-day, the two groups will receive standard 12-week varenicline~     treatment. Non-treatment follow-up will continue to 6 months.~      Measurements: The main outcome measure is carbon monoxide-verified complete abstinence rate~     (CAR) 6 months after quit-day. Other measures are: CAR at 3 months; point prevalence at 3~     and 6 months; change in motivation; cigarettes/day; differential dropout rate; decline in~     pulmonary function; COPD symptoms, episodes of exacerbation and medication; and adverse~     events.~      Sample size: One hundred twenty-one subjects per group will be necessary to detect CAR~     differences between the two groups of 15% at 6 months.~      Potential study limitations: The main potential limitation is the lack of 1-yr follow-up.~      Relevance: This study may provide useful preliminary information on the safety and~     efficiency of varenicline for gradual smoking cessation in low-motivated COPD smokers and~     it may assist in the preparation of a larger, more comprehensive trial.~   "
12406|NCT02894944|"~     Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y~     survival probability of less than 5% when all stages are combined. At present, only~     approximately 10%-20% of patients are considered candidates for curative resection. The~     majority of patients (50%-60%) are present with metastatic disease, and substantial number~     of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of~     diagnosis.~      Replication-competent Adenovirus-mediated Double Suicide Gene Therapy~     (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with~     prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of~     combination with standard chemotherapy with Theragene treatment is assessed in this study.~   "
12407|NCT02894931|"~     While previous atherosclerosis-related studies have focused mainly on the atherogenicity of~     lipids, the proposed study aims to investigate the effects of other dietary factors, i.e.~     monosaccharides, disaccharides, amino acids, or artificial sweeteners, on the atherogenicity~     of serum or macrophages. Findings from the current proposed study may shed light on yet~     unknown mechanisms by which the above dietary factors could affect atherosclerosis~     development and CVD risk and hence could possibly assist in the future development of~     anti-atherogenic strategies.~   "
12408|NCT02894918|"~     This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with~     nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This~     study is a Randomized, open-label, multi-center study.~      The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100~     PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:~      Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by~     Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49~     weeks. Note: NAs including: LAM, ADV, ETV, or TDF.~   "
12409|NCT02894905|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of~     AL-335 in participants with various degrees of impaired renal function (mild, moderate, and~     severe) compared to participants with normal renal function.~   "
12410|NCT02894892|"~     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan,~     there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric~     cancer development is known to follow a multistate process from non-atrophic gastritis,~     atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection~     plays the key role of this carcinogenic process. Although H. pylori eradication would result~     in a marked gastric cancer reduction, treatment success using standard regimens has become~     more difficult in recent years, and increased antibiotic resistance is considered the most~     important reason for decreased treatment efficacy. As no specific new medications have been~     introduced in recent years, novel treatment regimens have been created using different~     combinations, durations and sequences of available medications. The addition of bismuth~     improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori~     to bismuth has not been reported. Bismuth absorption is not required for efficacy in H.~     pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth~     with responsible for rapid destruction of H. pylori within the stomach remain unclear.~     Knowledge of the mechanism of action of bismuth compounds against H. pylori would be~     beneficial in the development of improved treatment regimens in this era of declining~     eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of~     H. pylori in specimen through electron microscopy after bismuth therapy and provide insight~     into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H.~     pylori therapeutic strategies.~   "
12411|NCT02894749|"~     This is a randomized prospective monocentric study to evaluate the benefits of a 3D~     rotational acquisition (3DRA) to assess technical success after treatment of infra-renal~     aneurysm with bifurcated endograft. Patients will be randomized between the standard~     strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and~     the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of~     radiation exposure and contrast medium used during the hospital stay, with a similar~     resolution between angioCT-scan and 3DRA to depict the main complications after EVAR~     (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group~     could benefit from an additional procedure during the same operating time, and therefore~     avoid a second intervention for the patient.~   "
12412|NCT02894736|"~     Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation~     treatment that is effective with no significant side effects. It can potentially be~     self-administered by patients in their own homes with remote monitoring, substantially~     reducing treatment costs and increasing accessibility, including to remote areas. This study~     will evaluate the feasibility and efficacy of home-administered tDCS treatment for~     depression.~   "
12417|NCT02894671|"~     The study has as general objective to analyze in the adult population, (male and female) the~     presence of a very common protein, in its normal form and modified, isolated from the blood~     of patients and called albumin. The opportunity to observe the distribution of this protein~     in the population, provides the basis to be able to perform this type of assay also in the~     population of patients with pathologies, in the near future, with the aim of increasing~     knowledge on the subjective tolerability to orthopedic implants.~   "
12418|NCT02894658|"~     The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment~     for meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of~     heat and pulsatile pressure. A recent study has observed that a single treatment with the~     LipiFlow system can decrease dry eye symptoms and objective findings of meibomian gland~     dysfunction for 1 year. We aim to see if the Lipiflow System will be beneficial in patients~     with Parkinsons disease who may have difficulty performing normal meibomian gland~     dysfunction treatment.~   "
12419|NCT02894645|"~     The overall objective of this study is to continue to improve the cure rate of childhood~     acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a~     multi-centre cooperative trial using a risk-stratified therapy based primarily on early~     response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.~   "
12420|NCT02894632|"~     A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing~     (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to~     model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to~     simplify patient installation.~   "
12421|NCT02894619|"~     This observational study evaluates prevalence of functional perinea disorders (stress~     urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults~     patients of the North-West CF Network. Its aims are to measure the severity of urinary and~     anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and~     social life and relationships ; identify the medical and demographic factors associated with~     the severity of urinary and anorectal disorders and their impact and determine the~     relationship between the severity of these disorders, various repercussions, and risk~     factors.~   "
12422|NCT02894606|"~     The investigators expect to better characterise B cell subpopulation and functional~     properties early after graft, to analyse effect of induction therapy (thymoglobulin versus~     basiliximab) on B cells, and to compare this B cell profiles with those obtained in our~     previous study in patients with chronic Antibody Mediated Rejection (cAMR)~   "
12423|NCT02894593|"~     The purpose of this study is to evaluate the antiplaque effects of an alcohol-free~     essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential~     oils (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash,~     and a negative control of a placebo solution (saline), using an in vivo plaque regrowth~     model of 3 days.~   "
12424|NCT02894580|"~     The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of~     sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more~     than 10 years ago and implantation's conditions tend to change.~   "
12425|NCT02894567|"~     The purpose of this study is to provide proof-of-concept that directional stimulation and~     directional recording, in an intraoperative setting, is perceivable in a subject. The tests~     will be performed using a dedicated intraoperative lead connected to an external~     neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.~   "
12426|NCT02894554|"~     The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported~     from 3% to 20.9%. And patient survival and graft survival rates following renal~     transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients.~     Due to viral replication in asymptomatic HBV carriers induced by post-transplant~     immunosuppression, liver-related complications, such as liver failure and bleeding, account~     for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.~      Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated~     antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal~     allograft recipients has significantly improved patient survival rates during short-term~     follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with~     chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related~     decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR~     increase was also observed in Lamivudine experienced CHB patients after switch to~     Telbivudine treatment.~      However, limited results were known about the renal function affected by oral anti-HBV drugs~     when patients received kidney transplantation. Therefore, we would like to conduct this~     study to evaluate the renal function of Lamivudine long term used HBsAg positive patients~     received kidney transplantation after switch to Telbivudine treatment. The clinical and~     virological outcomes will provide valuable insights of clinical practice.~   "
12427|NCT02894541|"~     The purpose of this study is to investigate the effects of food on the~     pharmacokinetics/pharmacodynamics of CKD-519.~   "
12428|NCT02894528|"~     Fifteen patients were selected, each presenting at least two jaw front teeth indicated for~     extraction: in the Test Group (TG), post-extraction sockets was filled by synthetic bone~     substitute ReproBone, and in the Control Group (CG) the socket was filled only by clot. In~     both groups, the sockets were covered by a resorbable collagen membrane BioMend, which in~     turn was covered by a flap. Computed tomography scans were acquired in the immediate~     postoperative period and 6 months after surgery, and the horizontal and vertical dimensional~     changes in bone crests were quantified.~   "
12429|NCT02894515|"~     The purpose of this study is to investigate whether 2 different tablet compositions are~     similar regarding absorption (uptake) in the body. One composition was used in the clinical~     development program and the other is intended for the market~   "
12430|NCT02894502|"~     The aims of this study will be to evaluate the effect of motivational interviewing (MI) to~     improve self-care in heart failure (HF) patients and caregiver contributions to HF~     self-care. Also this study will evaluate the effect of MI on the following secondary~     outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of~     life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use~     of emergency services, and mortality; In caregivers: generic quality of life, anxiety and~     depression, mutuality with patient, preparedness, social support and sleep quality.~   "
12432|NCT02894476|"~     The SUBUSQOL cohort aimed to improve knowledge of the quality of ambulatory care, in~     particular the prognostic role of the early satisfaction with care on the change from~     baseline quality of self-reported health status in outpatients with alcohol or opioid~     dependence. It is a multicenter prospective cohort. Satisfaction was assessed using a~     multidimensional self-administered and validated questionnaire during the early care~     process. In addition to measuring satisfaction and obtaining sociodemographic and clinical~     data, this study collected data on the self-reported health status at inclusion and 3, 6 and~     12 months after inclusion.~   "
12433|NCT02894463|"~     The aim of this study is to evaluate the potential risk of abusive behavior for children in~     care using nitrous oxide for dental care.~   "
12434|NCT02894450|"~     The objective of this study was to investigate whether there is a link between clinical and~     biological variables and bioassay high xaban in elderly patients as part of an unscheduled~     hospitalization.~   "
12435|NCT02894437|"~     The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care~     network of SCI patients whose general organization refers to the medical literature and the~     recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work~     (CFW) will be set up and semi-structured interviews will be conducted with patients and~     professionals. They will confirm or dismiss the CFW gradually with a refined coding As of~     domains and sub-domains of the skin preventing spinal cord injury related to the perceptions~     and behaviors of those involved in the sector. Quality control will be provided by experts~     in qualitative research and interviews will be stopped when the analyzes will further refine~     the domains and subdomains. A final framework will be validated to modulate our~     organization.~   "
12436|NCT02894424|"~     The idiopathic macular hole, age-related disease, is a major cause of vision loss and~     affects at least two persons in 1000 after 40 years.~      This hole causes an acute decline linked to a central scotoma. The only treatment is~     surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the~     tensile forces. To be sure the removed is complete and to facilitate the closure of the~     hole, a peeling of the internal limiting, the outermost layer of the retina, is often~     suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is~     colored with vital dyes to facilitate its removal. After closure of the macular hole, the~     central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is~     often described. This sensitivity decrease could be induced by the dyes used during surgery.~      This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant~     Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher~     concentrations, at least on the isolated retina models.~      It would be interesting to search for a decrease in retinal peri-foveal postoperative~     sensitivity after surgery of macular holes, performed with the usual dyes. Only~     microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive~     technique that explores the macular visual field. It is performed without iris dilatation~     and allows an automatic exploration ensuring rapid and accurate analysis of retinal~     sensitivity.~   "
12437|NCT02894411|"~     The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior~     oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO~     paralysis and of its congenital or acquired etiology, are based on a range of clinical~     findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side~     which increases in adducted position, the positivity of Bielschowsky head tilt test and the~     twisting of the eye fundus. These criteria are always considered together and are~     interdependent. The diagnostic value and the sensitivity of each of these signs is not~     defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding~     of the physiopathology of a number of oculomotor disorders.~      For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle~     is qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.~      The diagnostic value of various clinical signs observed in SO paralysis (sensitivity,~     specificity) remains unknown.~   "
12438|NCT02894398|"~     The purpose of this study is to evaluate the efficacy and quality of life in postmenopausal~     women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma~     of the breast), HR+ / HER2-, who are treated with letrozol as baseline therapy in~     combination with palbociclib (PD0332991)~   "
12439|NCT02894385|"~     Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety~     and tolerability of BAY 1841788 (ODM-201).~   "
12440|NCT02894372|"~     The purpose of the study was to assess the effectiveness of Faringomoss in reducing the~     throat discomfort and pain in patients with acute throat diseases and postoperative patients~     after throat surgeries.~   "
12441|NCT02894359|"~     Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary~     neck muscle activity causing abnormal head postures and movements. It is the most frequent~     form of adult focal dystonia. The distribution of dystonic muscles is unique for each~     patient, explaining the variety of patterns encountered.~      The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin~     injections and/or specific retraining therapy programmes. Therefore, analyzing the~     characteristics of abnormal head movements and identifying the dystonic muscles are the key~     points of these treatments.~      To a better understanding of the posture and movement disorders of head and neck, we wish to~     establish a three-dimensional (3-D) computer model of cervical spine movements of ten~     healthy subjects built from images obtained with the Cone Beam  system. Then we will~     compare the cervical posture and movements for each of ten CD patients matched in age and~     genre to the computer model. Comparison with patients' images in the axial plane~     reconstructed by computer with the 3-D computer model will lead to the description of~     various patterns of CD. Analysis of the musculoskeletal disturbances in CD should be a help~     to improve the localization of Botulinum Neurotoxin injection sites as well as retraining~     programmes.~   "
12517|NCT02893371|"~     The objective of this retrospective observational study is to compare commonly prescribed~     bipolar disorder medications for their impact on: (1) all-cause mortality; (2)~     hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of~     drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In~     addition, the investigators will examine heterogeneity of treatment effect by co-morbidity~     within pediatric, adult, and elderly sub-populations.~   "
12442|NCT02894346|"~     Since 2014 45 minutes of physical activity (PA) has been a mandatory part of all public~     schools in Denmark. PA has to be part of subject teaching, including Physical Education~     (PE), and of so-called support teaching. Research has shown that teachers not always find it~     meaningful to implement PA during lessons. In addition, even though PA seemingly has~     positive impacts on children's concentration and learning, teachers find it hard to~     integrate good quality PA with the learning objectives of any school subject. The purpose of~     this study is therefore to: 1) Analyse teachers' underlying factors of motivation for using~     PA as a learning tool using The Self Determination Theory (SDT), and 2) analyse how to~     support teachers' motivation by using the theory of scaffolding.~      The study uses mixed methods. Through quantitative and qualitative methods the study~     analyses behavioural patterns focusing on teachers' motivation for implementing PA and need~     for support. The process is iterative moving from a quantitative (survey) to a qualitative~     approach (interviews).~      The study provides new and important knowledge of teachers' motivation for implementing PA~     as a learning tool. Results from SDT analysis will point out teachers' levels of controlled~     versus autonomous motivation, and analysing teacher's need for scaffolding will give insight~     into how teachers' motivation can be framed in the process of implementing PA.~      There can be both potentials and barriers for implementing PA in a learning context, and in~     the process of implementing PA during school days the role of the teacher becomes crucial.~     It is therefore important to understand teachers underlying factors of motivation for using~     PA as a learning tool, and in order to help them carry out qualified and suitable PA, it is~     important that the investigators know how to support them and maintain their motivation in~     this process.~   "
12443|NCT02894333|"~     The ideomotor theory of action control is considered to be central to the understanding of~     human voluntary action. According to the ideomotor theory, an action is represented in terms~     of its desired sensory effects and actions are selected by internally activating these~     effect representations. Recent imagery and behavioral studies showed that this anticipated~     representation of action-effects triggered a sensory attenuation, meaning a decrease of~     perceptive performances or a decrease of sensory event-related potentials (ERP) for an~     expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to~     investigate sensory anticipation impairment in patients with Parkinson's disease. In a~     behavioral paradigm, patients and matched control participants have to perform a perceptive~     task on predicted visual action-effects mixed with mispredicted visual action effects.~     Performances should be better in mispredicted visual action effects for control participants~     only.~   "
12444|NCT02894320|"~     The ability to predict sensory effects of people's own motor actions is a key component of~     Human action realization. Recent studies revealed this anticipation process to be involved~     in early and late stages of voluntary actions. Nevertheless, the question whether the~     action-effect anticipation is impacted or not by motor pathologies, such as the~     Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by~     using a subliminal priming paradigm in patients with Parkinson's disease and in matched~     control participants. Indeed, subliminal primes corresponding to visual action-effects are~     displayed at different time points before the actions' execution. Results should allow to~     determine whether or not the action-effect prediction is impaired at different stages of~     voluntary action in patients with Parkinson's disease.~   "
12445|NCT02894307|"~     Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients~     with atrial ﬁbrillation or prosthetic heart valve and the incidence of death and recurrences~     in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the~     standard therapy for patients with a metallic valve, or bioprosthesis with atrial~     fibrillation (AF). The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves~     (RE-ALIGN) trial comparing dabigatran etexilate to warfarin was the only randomized~     controlled study in patient with mechanical valve prosthesis, but it was terminated~     prematurely because of an excess of thromboembolic and bleeding events among patients in the~     dabigatran group. To date, novel oral anticoagulants (NOACs) have shown to be not both safe~     and or effective for patients with mechanical valves.~   "
12446|NCT02894294|"~     Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health~     Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although~     randomized controlled trials have shown SMC to be highly effective, evidence and experience~     from routine implementation of SMC has been lacking. For these reasons, we conducted a~     comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection~     and disease and anemia when delivered through routine programs using existing community~     health workers in the Kayes region in Mali. Our evaluation used a pre-post design with~     cross-sectional surveys and abstraction of routine health information system data in an~     intervention district (Kita) where SMC was implemented through the health system, and a~     comparison district (Bafoulabe) where SMC was not implemented.~   "
12447|NCT02894281|"~     Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation.~     It causes a rapidly progressive and painful visual loss, often among young subjects.~     Diagnosis confirmation is important to start proper treatment, because a NORB is often the~     first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is~     difficult to define by a non-expert ophthalmologist.~      The pupillary light reflex is a way to test the visual afferent pathways. If it is subject~     to a large inter-individual variability, the dynamics of the pupillary light reflex and its~     latency are more reproducible. An easy way to study the dynamics of the pupillary light~     reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the~     conduction in the visual afferent pathways related to demyelination plate increases the~     latency of the pupillary light reflex and decreases the frequency of the PCT.~      Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to~     evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease~     in the frequency of the PCT in NORB, compared to the frequency observed in subjects~     ophthalmological or neurological disease, could help developing methods to study the~     conduction of the visual pathways with portable devices used during the standard~     ophthalmologic consultation and quickly orientate patients to specialized centers.~   "
12448|NCT02894268|"~     Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue~     treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is~     superior of tailored therapy as rescue treatment for helicobacter pylori Infection after~     failure of several therapy.~   "
12449|NCT02894255|"~     This prospective multicenter registry evaluates the efficacy of hybrid coronary~     revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous~     coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is~     to be performed in the left anterior descending artery and the left circumflex artery using~     only arterial grafts, whereas PCI is to be conducted for the treatment of significant~     stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This~     research plans to involve patients scheduled for coronary revascularization for multivessel~     coronary artery disease who consent to participate in the registry.~   "
12451|NCT02894229|"~     The primary purpose of the present study is to investigate the relationship between~     mindfulness and stress habituation. The investigators propose to measure the effect of~     mindfulness on stress habituation by randomly assigning participants to a 6-week~     mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group~     comparison intervention, or a waitlist control condition followed by repeated acute~     psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be~     collected from participants throughout both laboratory testing sessions to measure HPA axis~     activation (an essential stress-responsive system), along with other measures of~     physiological and psychological stress (e.g., heart rate, blood pressure, emotions).~     Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral~     skills group condition is an appropriate comparison group due to the well-documented~     efficacy of cognitive-behavioral interventions on stress.~   "
12452|NCT02894216|"~     The investigators retrospectively reviewed all radionuclide shuntographic tests using~     (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in~     nuclear medicine department of Far Eastern Memorial Hospital. The results of shuntography~     were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests~     were interpreted as normal and abnormal, including complete distal obstruction, partial~     distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on~     subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the~     investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value~     (PPV), negative predictive value (NPV) and overall accuracy.~   "
12453|NCT02894203|"~     The investigators aim to explore the psychobiological effects of a 5-day meditation~     intervention on offenders within dangerous and severe personality disorders (DSPD) unit at~     HMP Whitemoor. DSPD unit accommodates offenders with psychopathy or with two or more~     personality disorders. DPSD unit provides them with a 5-year rehabilitation programme that~     consists of group and individual therapy and aims to improve their self-regulation.~      This project includes a total of 60 participants and has two major methodological~     innovations. First, it will include yoga as an active control group that will be matched to~     the meditation intervention (which means it will have the same length and the same social~     components) and a passive control group that will be following their usual regimen. Thus,~     the effects of meditation will be contrasted with another type of intervention and with not~     receiving any intervention.~      The second methodological innovation is the combination of psychological and biological~     measures. Psychological measures include questionnaires (emotion regulation, mindfulness,~     stress) and cognitive measures (attention,empathy,behavioural control). Biological measures~     include EEG to measure brain activity related to empathy; gene expression and protein~     interlukin-6 to measure changes in immune system; and stress related hormone cortisol. The~     investigators also aim to determine to whom does meditation benefit the most by exploring~     how initial expectations of meditation, personality, mood and previous life adversity~     predict outcomes of meditation or yoga. The data will be collected at three time points: at~     baseline, immediately after and 10 weeks after the 5-day intervention.~      The investigators expect that meditation and yoga will similarly improve mental and physical~     health. If this hypothesis are confirmed, these results will extend previous findings on the~     benefits of meditation and yoga to vulnerable populations, and would provide a~     cost-effective addition to prisoner rehabilitation.~   "
12454|NCT02894190|"~     The main aim of this study is the development of the Beliefs about Ventilation Questionnaire~     (BVQ).~   "
12455|NCT02894177|"~     Difficult weaning from ventilation and extubation failure are major issues in intensive~     care, concerning 30% and 12% of patients respectively. These can be partly explained by the~     lack of accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation~     failure. The investigators performed a pilot study to evaluate transcutaneous carbon dioxide~     pressure (tcPCO2) monitoring during SBTs. The results showed that the difference between~     maximum and initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients~     who failed SBTs according to the usual criteria. Moreover, the results suggested that~     ΔtcPCO2 could be an accurate and early criterion for SBT failure. The size of the study~     could not examine ΔtcPCO2 regarding extubation failure. Therefore, the main objective of~     this study is to determine if Δ tcPCO2 during SBTs is associated with extubation failure.~   "
12456|NCT02894164|"~     This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during~     intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are~     performed.~      The purpose of the study is describe renal function in AKI survivors at follow up .~      Additional aims are to determine how well admission values of renal function markers perform~     as predictors of renal function at follow-up and whether estimates of renal function at~     follow-up differ depending on which renal function marker is used.~   "
12457|NCT02894151|"~     The primary objective : To compare effectiveness of pain control in endometriosis associated~     pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding~     pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS~     and DMPA in treatment of endometriosis associated pelvic pain~   "
12458|NCT02894138|"~     In this study the investigators test the hypothesis that alteplase given intra coronary~     after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and~     impaired microvascular function defined as a value of index of microvascular resistance~     (IMR) >30.~   "
12459|NCT02894125|"~     Low back pain is considered to be chronic if it has been present for longer than three~     months.~      This pathology is extremely frequent with an annual incidence between 5 in 10 % of the~     general population. Thus she is frequently met in general medicine, in particular to the~     ageing subject. It is the 2nd motive for consultation.~      The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable~     great majority of the cases but she pulled a socioeconomic cost mattering with a~     poly-consumption of care, in private individuals.~      The primary objective of this study is to determine the impact of a 3 months SPA Therapy on~     the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy~     of 3 weeks to Neyrac-les-Bains.~   "
12460|NCT02894112|"~     Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed~     in the regular diet. Milk products are unique in that they produce high insulin response~     despite their low glycemic index. The general aim of the proposed study is to determine the~     effect of fluid milk on attenuating the postprandial surge in plasma glucose and~     triglyceride after meals and its associated physiological mechanisms. The investigators~     hypothesize that the consumption of one or two servings of non-fat milk added to a standard~     oral glucose tolerance test (OGTT) solution or the high fat tolerance test meal will~     attenuate postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that~     the postulated improvement in postprandial metabolic response due to the consumption of~     fluid milk will be associated with increased postprandial insulin secretion as well as~     insulin-mediated endothelial vasodilation and whole-limb perfusion.~   "
12461|NCT02894099|"~     In adults, the sedentary behavior was related to cardiovascular risk markers, regardless of~     the level of physical activity (PA). However, the interruption of prolonged sedentary time~     has shown positive results even when performed in breaks of low intensity and short duration~     of activity. The aim of this study is to analyze the influence of a sedentary uninterrupted~     period, as well as different forms of breaks in sedentary time for the glycemic, insulin and~     inflammatory markers responses in older adults. This is a controlled clinical trial to be~     conducted in older (≥ 65 years) and sedentary (<150 min / week of moderate to vigorous~     physical activity) people. Those with BMI ≥ to 35.00 kg /m2; diabetic, on medication for~     glycemic control, or with absolute or relative contraindications to PA practice will not be~     included . Participants will undergo four phases of intervention separated by an interval of~     7 days: (1) Prolonged Sitting Time(PST), in which older people will stay for 5 hours seated;~     (2) Prolonged sitting with PA of light intensity and short duration (LiSd), time sitting is~     interrupted for PA bouts of 50-60% of the Heart Rate (HR)max; (3) Prolonged sitting with PA~     of moderate intensity and short duration (MiSd), time sitting will be interrupted for PA~     bouts of 65-75% predicted HR max; (4) Prolonged sitting with PA of moderate intensity and~     long duration (MiLd,) time sitting will be interrupted with PA bouts of 65-75% of HRmax. PA~     bouts will be performed by walking into a hallway every 20 minutes of sitting time and will~     last 2 minutes, except in MiLd phase (10 minute breaks every 75 minutes). To evaluate the~     effects of different PA interruptions in plasma glucose, serum insulin and inflammatory~     markers, blood samples will be collected serially (-30min, Baseline and 30min, 1h, 2h, 3h,~     4h and 5h after a standardized meal. It is expect that interruption of sedentary time, even~     with breaks of short duration and light intensity can bring benefits to cardiovascular risk~     markers even in the elderly.~   "
12462|NCT02894086|"~     Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about~     80,000 cases a year (in France). It mainly affects young adults but is associated with a low~     complication rate and a short stay in hospital. Ambulatory treatment is an innovative type~     of care in which the patient is hospitalized for less than 12 hours and does not stay~     overnight in hospital.~      Ambulatory care is based on the guidelines issued by three French learned societies (the~     SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national~     priority.~      The literature data show that 20% of patients undergoing appendicectomy for acute~     appendicitis can be treated on an ambulatory basis. However, the success factors for~     short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours)~     have yet to be identified.~      The investigators thus intend to perform a retrospective study of data from the PMSI French~     national hospital information system, in order to identify factors that are predictive of a~     length of hospital stay below 24 hours in patients having undergone appendicectomy for acute~     appendicitis during 2013 in France. The objective is to define the population of patients~     that could potentially benefit from ambulatory care.~   "
12463|NCT02894073|"~     Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in~     anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be~     challenging in the obese patient - even for the most experienced healthcare professionals.~      In a study, PVC placement was considered to be difficult in 46% of obese patients but only~     13% of non-obese patients.~      Placement of a central venous catheter is an option when PVC placement is impossible,~     although central access is associated with a non-negligible risk of complications~     (pneumothorax, infection, arterial puncture, etc.).~      Facilitating peripheral venous access in obese patients should shorten the time required for~     PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and~     discomfort for the patients) and limit the use of a central venous catheter.~      Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from~     Christie Medical) have been developed to guide PVC placement, there are no literature data~     on the value of these devices in the management of difficult venous access in obese~     patients.~   "
12464|NCT02894060|"~     Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents)~     are one of the main causes of mortality in the general population. The recruitment of~     macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated~     LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells~     characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are~     rarely followed by clinical events, but can progress to complicated atheromatoses~     (calcification, rupture) resulting in the occurrence of various clinical events such as~     myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes~     immunogenic and induces anti-LDLox antibody production that could be markers of progression~     of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE)~     such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are~     generated. In order to measure the level of markers in the blood, researchers developed a~     series of immunologic levels in vitro, using specific antibodies directed against~     well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter~     of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB~     concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality~     due to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all~     other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more~     specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36~     (sCD36) was recently identified. In this study, only healthy volunteers were recruited in~     order to be able to establish normal serum ranges of different immunologic biomarkers.~   "
12465|NCT02894047|"~     Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in~     adults. The erosive damage influences the functional prognosis in patients with RA. At~     present, there are no sufficiently sensitive and specific predictive markers of erosive~     damage.~   "
12466|NCT02894034|"~     Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence~     (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).~      Prognostic tools are indispensable in guiding and optimizing the care of these patients.~      Some diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP,~     occurrence of complications) as well as some classification schemes used for grading~     seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).~      A tool that is simple, reliable, reproducible, non costly, non invasive, and simple to~     perform (including remote methods and without changing planned patient care) would be ideal.~      The measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound~     in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for~     SAH) could be one of these tools.~      This measurement, previously demonstrated using ultrasound, could be carried out at the time~     of the patient's initial cerebral scan.~      In practice, at admission each patient undergoes a cerebral CT scan much more often than an~     ultrasound (faster, less costly, less technical training required).~      Two preliminary studies seem to suggest that this measurement of ONSD on CTc is a predictive~     factor for morbi-morbidity in patients having serious traumatic skull fractures.The~     measurement is reliable, reproducible, non invasive, and non costly, with good sensitivity~     and specificity.~      Proving that it is also applicable to SAH could be particularly useful.~   "
12802|NCT02889666|"~     The purpose of this study is to determine if the commonly administered chemotherapeutic~     agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid~     tumors in clinical oncology, either a single format or given as combinations followed by~     surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer~     patients.~   "
12467|NCT02894021|"~     Lymphoceles, or seromas, are the most frequent complication following mastectomy and are~     associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as~     the presence of a palpable post operative serous accumulation that is bothersome for the~     patient and requires a puncture and drainage or even several repeated punctures. The~     presence of seromas is therefore associated with discomfort and pain. Seromas could also be~     responsible for increased morbidity due to complications such as infection, suture~     separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct~     treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as~     obesity, increased post operative drainage of J1 to J3, and arterial hypertension.~      Different measures have demonstrated the benefits of limiting axillary lymphoceles after~     dissection : placement of a drain, padding and delay in shoulder mobility.~      Studies have shown that axillary padding decreases lymphocele development and shortens the~     length of hospital stay. Some studies based on padding of the mastectomy site also have~     shown a decrease in post operative seromas; however no study has been done on the usefulness~     of padding in the mastectomy site alone because they include both padding and a drain or~     padding of the axillary area.~      The padding technique the investigators employ is performed at the donor site in breast~     reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of~     seromas.~      In this study, the classic technique will be compared to padding in the mastectomy site with~     short drainage (48h).~   "
12468|NCT02894008|"~     This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in~     patients with persistent post kala azar dermal leishmaniasis (PKDL).~      This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral~     and cellular immune responses generated by the candidate vaccine in patients, and observe~     any clinical changes in the disease over a 42 day period following vaccination.~      Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight~     volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp~     or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC~     review.~   "
12469|NCT02893995|"~     This is an open-label, multicenter, parallel, randomized (1:1 Slow Dose Titration Group;~     Rapid Dose Titration Group), two-group study to evaluate the safety, tolerability,~     pharmacokinetics and efficacy of slow and rapid dose titration regimens of subcutaneous~     Remodulin infusion in subjects with pulmonary arterial hypertension (PAH). The study will~     include about 50 subjects at up to 10 clinical trial centers in China. The treatment phase~     of the study will last approximately 16 weeks. Subjects who complete all required~     assessments will also be eligible to enter a long-term open-label, extension study~     (CVT-CV-004).~   "
12470|NCT02893982|"~     The objectives of this study are to demonstrate feasibility of an optimized, image-guided~     pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while~     maintaining established dose constraints to normal tissues, and to determine the maximum~     tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a~     pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver~     lesions.~   "
12471|NCT02893969|"~     The goal of this study is to investigate when is the best time to resume physical activity~     following a head injury. Two treatment plans will be studied; the first treatment plan~     consists of gradually reintroducing physical activity in the child's routine, starting 72~     hours following the head injury. The second treatment plan involves physical and mental rest~     until the child as no more symptoms. Once symptom free, physical activity is gradually~     reintroduced in the child's routine.~   "
12472|NCT02893956|"~     Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery~     vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus~     screening may generate this hemodynamic response and whether postural support would be able~     to modulate it.~      Study design~      Prospective, single center, randomized study in less than 29 weeks of gestation neonates,~     with a post natal age < 48 hours, and requiring invasive mechanical ventilation.~      Crossover design with order of echocardiographies determined by computer randomization: in~     one group ultrasounds are performed with postural support, than standard conditions, in the~     other, ultrasounds are performed in standard conditions than with postural support.~      The objective of the study is to assess the ratio of the acceleration time/ejection time of~     pulmonary arterial flow.~      The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus~     shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right~     and left ventricular functions using tissue Doppler imaging and speckle-tracking~     echocardiography), pain assessment with a clinical scale and heart rate variability~     analysis.~   "
12473|NCT02893943|"~     The aim of the study is to evaluate the potential of probiotics on weight management. It is~     hypothesized that the consumption of 1 capsule of probiotics daily will modulate the~     intestinal gut microbiota thereby reducing body weight and fat compared to those who do not~     consume probiotics. In addition, a diet supplemented with probiotics can be expected to be~     more beneficial than a diet without probiotic supplementation in impacting biomarkers of~     obesity-associated disorders including diabetes, hypertension and CVD.~   "
12474|NCT02893930|"~     This phase II trial studies how well sapanisertib works in treating patients with pancreatic~     neuroendocrine tumor that has spread to other places in the body, does not respond to~     treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth~     or shrink tumor cells by blocking some of the enzymes needed for cell growth~   "
12475|NCT02893917|"~     This randomized phase II trial studies how well olaparib with or without cediranib works in~     treating patients with hormone-resistant prostate cancer that has spread to other places in~     the body. Olaparib and cediranib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
12476|NCT02893904|"~     A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics~     administration. The BIS, which provides a single number resulting from an algorithm~     calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and~     propofol may have different EEG effects, which might interfere on measured BIS values.~      The aim of this prospective randomized study was to compare, in steady state conditions, the~     EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both~     anesthetics, the BIS-concentration relationship and raw EEG were analysed at different~     levels of general anesthesia.~   "
12477|NCT02893891|"~     Literature data clearly demonstrate that treatment of obese patients is very expensive, long~     and achieve weight loss may not be permanent, and regardless of whether the treatment~     dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade~     has shown that after surgical interventional treatment of obesity occurs not only long-term~     (10 years and over) weight loss of 35-40%, but also an important endocrine changes.~      In recent years, it was discovered a number of signaling molecules produced by adipose~     tissue, whose physiological significance beyond the general metabolic aspects organism. The~     fat is therefore currently understood as an endocrine organ whose hormones modulate the~     function of many systems, including the skeleton. These hormones include the adipokines that~     modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by~     activation of neurohumoral hypothalamic centers - Leptin.~      Studying endocrine interactions between adipose tissue and bone is a highly topical issue.~     This mutual communication is a homeostatic feedback system in which adipokines and molecules~     secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone~     tissue. However, the mechanisms of this axis remain largely unknown.~   "
12478|NCT02893878|"~     The purpose of this 2016/17 pilot study is to improve the combination of a card-based~     adverse drug reaction (ADR) system and the use of routine data to collect adverse events~     following vaccination with seasonal influenza vaccines, as per European Medicines Agency~     (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements,~     and to identify additional data which may need to be collected in order to appropriately~     address the requirement.~   "
12479|NCT02893865|"~     Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of~     coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.~      Investigators hypothesise that oxidative stress decrease after 3 months of continuous~     positive airway pressure (CPAP) in this specific population.~      The results may have major implication in the comprehension of physiopathologic processes~     linking OSAS and CAD and in the treatment of OSAS in this specific population.~   "
12480|NCT02893852|"~     The purpose of this study is to investigate the effects of the Cognitive Orientation to~     daily daily Occupational Performance Approach (CO-OP Approach) on activity and participation~     in school-aged children with developmental coordination disorder (DCD).~   "
12481|NCT02893839|"~     Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever~     suspicion of allergy were asked to participate in the study. Besides a standard battery of~     respiratory allergens, native raw and cooked potato were tested by means of the prick to~     prick method, using a metal lancet.~   "
12482|NCT02893826|"~     Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in~     the treatment of aneurysmal subarachnoid hemorrhage.~   "
12483|NCT02893813|"~     Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic~     watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of~     lacrimal point. The objective of the study is to compare two surgical strategies for eyelid~     ectropion combined with ectropion of the lacrimal point~   "
12484|NCT02893800|"~     The project aims to make new technologies for locating people with dementia easier to use~     for the patients and those caring for them.~      Objective: To systematically understand what improves the user experience of persons with~     dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately~     allow users to obtain more benefits from using these watches.~      Aim: Improving the user experience of PwD and CG with locating system watches using a~     cross-over design and a theory-based educational session approach.~   "
12485|NCT02893787|"~     The main goal of this study is to compare the values of echocardiographic parameters~     obtained by Speckle Traking analysis on myocardial function among patients under 18 years~     treated with anthracyclines in childhood, with healthy age and sex mached volunteers.~   "
12486|NCT02893774|"~     Generally, French studies concerned with the quality of life of cancer patients focus on the~     period of treatment (up to 2 years post diagnosis). However, studies about quality of life~     after cancer are relatively rare (= long-term quality of life, or from 5 years post~     diagnosis). These studies mainly concern the most common cancers (breast and prostate).~      Or changes in quality of life after treatment could be different depending on the type of~     cancer. In addition, there is a significant influence of sociodemographic variables on the~     quality of life in remission.~      Similarly using remote diagnostics, quality of life questionnaires related to health, must~     be reassessed because too often developed for situations in process.~      Based on these findings, ELCCA II study proposes to study for five years, the evolution of~     the impacts of two types of cancer (breast and melanoma) on quality of life (overall and~     related to the subjective health), socioeconomic status, and behavioral and emotional~     dimensions (post-traumatic development, coping, anxiety-depression) of those treated.~   "
12487|NCT02893761|"~     A database of breast cancer patients was established at Institute Bergonié since the 90s ,~     to assess patients' survival, assess practice, search for prognostic factors.~   "
12488|NCT02893748|"~     The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep~     vs the standard of care Split-dose PEG prep used prior to colonoscopy.~   "
12489|NCT02893735|"~     The aim of this study was to evaluate the clinical performances of nano-hybrid resin~     composite systems used for anterior diastema closure and tooth reshaping at 4 years in~     service using FDI Criteria.~      Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to~     be used on each patient were randomly selected. Thirty-seven teeth (10 patients) were~     restored with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in~     Group 1; whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer)~     in combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic,~     functional and biological properties of the restorations were evaluated at baseline, 1-4~     years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using~     the Fisher's Chi-Square (p=0.05).~   "
12490|NCT02893722|"~     This study intends to carry out a prospective, randomized, double blind and controlled study~     to compare the influence of Atosiban and placebo on uterine contraction frequency,~     endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo~     implantation rate and clinical pregnancy rate on the RIF population after fresh embryo~     transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF~     and provide evidence-based basis for Atosiban for application in RIF population.~   "
12491|NCT02893709|"~     The objectives of this study are to examine the effects of ethnicity, gender, and proton~     pump inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize~     that PPI therapy might perturb microbial communities and alter the gut microbiome. Young,~     healthy subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to~     provide a baseline stool sample (Day 1) and were then given a course of omeprazole at~     therapeutic dose (20 mg daily) for a duration of 7 days. Stool samples were collected again~     on Day 7 and Day 14 (one week after stopping omeprazole). The DNA samples were subjected to~     16S ribosomal ribonucleic acid (rRNA) sequencing.~   "
12492|NCT02893696|"~     After injection of the spinal anesthetic drug, women will be allowed to lie down immediately~     (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal~     hypotension and fetal umbilical cord blood pH will be recorded.~   "
12493|NCT02893683|"~     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially~     memory function.~      Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165~     healthy volunteers were studied for its normalization.~      The main objective of the present study is to assess the validity of PVLT by comparing MS~     patients' test results to a database including the test results of 280 healthy control~     subjects, following recommended international standards (Benedict & al., 2002).~   "
12494|NCT02893670|"~     Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel~     diseases (IBD) to adult care is necessary in order to secure continues clinical management~     and to prevent possible deleterious clinical and psychosocial implications. In recent years~     there is an emphasis on successful transition, however, there are no standardized models or~     consensus guidelines incorporating both clinical and psychosocial aspects of transition.~     Objectives: To examine the effect a comprehensive clinical and psychosocial transition~     package on clinical management and patients outcomes in adolescents with IBD. Design: A~     prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the~     Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD~     and are planned to initiate transition process to adult care. Main outcome measures: Change~     in clinical management as a result of tailored re-evaluation as a part of tailored~     transition package. Secondary outcome measures: a. The effect of a tailored transition~     package on patients' self-efficacy perception and readiness for transition. b. The effect of~     a tailored transition package on patient's outcomes (disease activity, flares,~     hospitalizations) during the first year following transition.~   "
12495|NCT02893657|"~     The aim of the present study is the evaluation of the occurrence and effect of hepatic~     dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in~     liver haemodynamics in the early postoperative period.~   "
12496|NCT02893644|"~     Prospective study aiming to measure central ablation depth during excimer laser surgery in~     myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP,~     before and after laser ablation. This measurement will be compared with pre and 1 month~     postoperative topography differential pachymetric measurements.~   "
12497|NCT02893631|"~     Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery~     occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis~     induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration~     of these effects are unknown. Thus management of antithrombotics and hemostasis during~     thrombectomy and surgery is an issue.~      Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis,~     coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to~     evaluate the time required for the normalization of these disorders.~      Methods : Observational monocentric study including rtPA-treated patients requiring~     endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA~     administration to assess of fibrinolysis, coagulation and platelet functions with point of~     care devices and specific laboratory tests. Record of clinical and biological data.~   "
12498|NCT02893618|"~     Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of~     DCCR, 1 of which is administered both with and without food.~   "
12499|NCT02893605|"~     This is a case-control study performed on a biological collection. The polymorphisms present~     on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis~     (sporadic type) DNA samples and 400 control DNA samples.~   "
12500|NCT02893592|"~     The photorefractive keratectomy was the first correction mode refractive laser. It's a~     photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of~     epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a~     lot of interests: facility and speed of procedure as well as suppression of human variable.~     Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non~     inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive~     efficiency~   "
12501|NCT02893579|"~     This is a single center, randomized controlled trial which will include women with ischemic~     heart disease to receive either a self-directed stress reduction program delivered through a~     smart-phone application or activity tracking only for the first month (early SR~     intervention and delayed SR intervention, respectively). Patients will be monitored for 1~     month for application use and step counts via telephone or email interview and/or collection~     of screen-captured data. Baseline questionnaires will be repeated at the end of one month to~     assess for all primary and secondary measures, at which time the control group (activity~     tracking only) will be introduced to the intervention program. The early SR intervention~     group will not receive a new intervention but will be encouraged to continue using the app.~     Data will be collected for an additional 2 months with all participants in both groups.~     After the three-month study period, the study will close with the collection of final~     questionnaire data.~   "
12516|NCT02893384|"~     Pain following mastectomy surgery for breast cancer can be significant. Poorly managed pain~     in the immediate time-period following surgery can potentially lead to long-term (chronic)~     pain conditions. There is still a need to find the safest, least invasive, and most~     effective method to manage this pain. The investigators believe that a new technique of~     injecting local anesthesia (freezing) in to specific areas at the end of mastectomy surgery~     may be a very important step to managing pain after breast surgery. The investigators would~     like to begin by performing a pilot study, meaning the investigators will perform the~     technique in patients and compare what their pain outcomes are to patients who have not had~     the technique.~   "
12502|NCT02893566|"~     This is an eight-month research project using one group pretest-midst-posttest design. This~     study is based on self-efficacy and self-regulation of Social Cognitive Theory. The~     investigators will recruit 50 university students with a body mass index of 24 kg/m2 or~     above at one university campus. Participation is completely voluntary. After pretesting, a~     12-week Mi Band Step Challenge will be launched immediately. Participants will be assessed~     with the validated instruments of International Physical Activity Questionnaire~     (IPAQ)-Taiwan short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and~     self-regulation questionnaires. Mi Band activity trackers will be used to monitor step~     counts. An ioi 353 body composition analyzer will be used to assess body composition. Data~     will be analyzed using generalized estimating equation (GEE).~      The expected outcomes of this study include: (1) Mi Band Step Challenge will be developed~     based on the theory, which is expected to be effective. If this is true, the intervention~     can be packaged and applied at different types of colleges and universities with overweight~     students. (2) Mi Band Step Challenge has the potential to be used for the reference of the~     healthy weight - physical activity, which is embedded in the School Health Promotion Program~     executed by the Ministry of Education. (3) The result of this study can serve as an example~     for the promotion of evidence-based health care.~   "
12503|NCT02893553|"~     Dysregulation of blood pressure (BP), secondary to decentralized autonomic nervous system~     (ANS) control of the cardiovascular system, often results in chronic hypotension and~     orthostatic hypotension (OH) in persons with spinal cord injury (SCI), particularly in those~     with high cord lesions (i.e., above T6). While most hypotensive individuals with chronic SCI~     remain asymptomatic and do not complain of symptoms associated with cerebral hypoperfusion,~     evidence of reduced resting cerebral blood flow (CBF) has been reported in association with~     low systemic BP in the SCI and non-SCI populations. Reduced CBF in hypotensive individuals~     may lead to cognitive dysfunction, and we reported significantly impaired memory and~     marginally impaired attention processing in hypotensive individuals with SCI compared to a~     normotensive SCI cohort. Furthermore, we found that CBF was not increased during cognitive~     testing in individuals with SCI, which may contribute to impaired cognitive function~     compared to non-SCI controls. Although asymptomatic hypotension may have an adverse impact~     on cognitive function and quality of quality of life (QOL) clinical management of this~     condition is extremely low. In fact, we reported that while nearly 40% of Veterans with SCI~     were hypotensive, less than 1% carried the diagnosis of hypotension or were prescribed an~     anti-hypotensive medication. The discrepancy between incidence and treatment of asymptomatic~     hypotension in the SCI population may relate to a paucity of treatment options which are~     supported by rigorous clinical trials documenting safe and effective use of anti-hypotensive~     therapy on BP, CBF and cognitive function. We hypothesize these study medications may~     increase systolic blood pressure to the normal range and improve cerebral blood flow~     velocity. Results and conclusions will not be removed from the record.~   "
12504|NCT02893540|"~     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with~     metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the~     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy~     versus conventional chemotherapy.~   "
12505|NCT02893527|"~     Evaluate and compare the return to work rate at 12 months~   "
12506|NCT02893514|"~     This study will develop a clinical decision support tool that assists primary care providers~     in carrying out substance use interventions, and then compare (in Phase 2) two clinical~     scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention~     received) and changes in drug use at 3 and 6 months, among primary care patients.~     Investigators will develop the Clinical Decision Support (CDS) component and then test the~     full SUSIT approach, using mixed methods to assess its acceptability and adoption, and~     gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development~     is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a~     secondary study site to avoid contaminating the SO condition.~   "
12507|NCT02893501|"~     The objective of this study is to evaluate the microbiome composition of infant's (9-12~     month) skin experiencing diaper rash in order to determine if the onset and severity of~     erythema associated with diaper rash is influenced by the type of bacteria colonizing the~     skin.~   "
12508|NCT02893488|"~     This is an open-label, randomized, crossover study in healthy adult subjects with 5~     treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters~     and relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of~     TRIUMEQ™ ([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed~     under four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) +~     EPZICOM™ (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately~     20 subjects will be randomized, each to one of 5 treatment groups. The total duration of~     participation of a subject in this study will be approximately 10-11 weeks. It will include~     a screening visit within 30 days prior to the first dose of study drug, five treatment~     periods each with a single dose of study drug per treatment period and a follow up visit~     within 7 10 days after the last dose. There will also be a washout of at least 7 days~     between doses in each treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the~     GlaxoSmithKline group of companies.~   "
12509|NCT02893475|"~     Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal~     disease (ESRD) in terms of life expectancy and quality of life. This method allows~     preemptive transplantation, before beginning dialysis.~      The main objective of this study will be to investigate quality of life and societal~     participation in a population of LD kidney transplant recipients comparing preemptive LD~     transplantation versus non-preemptive transplantation (performed after a period of~     dialysis).~   "
12510|NCT02893462|"~     The aim of this study is the establishment of a warehouse physiological data and biomedical~     signal in intensive care adult patients in acute situations from particular records from the~     Philips Intellivue MP70 monitor.~   "
12511|NCT02893449|"~     Main objective:~      To assess the impact of a structured program of preoperative cognitive remediation on~     postoperative social adaptation in patients suffering from Parkinson's disease profiting~     from bilateral subthalamic nucleus stimulation.~      Secondary objectives:~      To assess in the same patients the impact of structured program of preoperative cognitive~     remediation on quality of life, mood, anxiety, apathy and psychologic, social and~     professional functioning depending on psychiatric symptomatology after intervention.~   "
12512|NCT02893436|"~     The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment~     when 2 responses to double burst stimulation are visually identical and this for 95% of~     patients.~   "
12513|NCT02893423|"~     With this research the investigators hope to determine the lowest dose of ropivacaine used~     in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after~     cesarean section (c-section).~   "
12518|NCT02893358|"~     The primary purpose of the study is to estimate the target organ protection after 12 months~     of antihypertensive treatment in masked hypertension patients with at least one kind of~     target organ damage (left ventricular hypertrophy, large arterial stiffness and~     microalbuminuria). Improvement was defined as the relevant parameter back to normal or~     declined at least 20%.~      The secondary objectives include: blood pressure lowering effect, target organ damage~     parameters improvement, and the incidence rate of all cause death and cardiovascular events~     (stroke and myocardia infraction).~   "
12519|NCT02893345|"~     People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk~     for unintentional injury and harm when resuming day to day activities in the home and~     community. People who sustain brain injuries primarily want to independently do the~     activities they enjoy while families primarily focus on avoiding injury or other harm~     events. Safe@Home is an injury prevention education and activity training program.~     Participants who have sustained a moderate or severe TBI receive a personalized strengths~     and safety risk assessment, tailored injury prevention education, and in-home training with~     a transition coach on self-selected activities. This study will evaluate whether the~     Safe@Home program reduces injuries and harm and increases clients' independence in their~     everyday activities in the home and community compared to a usual care control group.~   "
12520|NCT02893332|"~     To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than~     or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS)~     compared to TKI alone.~   "
12521|NCT02893319|"~     Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later~     in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated~     with early rapid growth, and include high maternal BMI prior to pregnancy and excessive~     gestational weight gain. This research focuses on aspects of early feeding as potentially~     modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized~     to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks~     postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads~     are also included. The hypothesis is that differences in feeding practices will be~     associated with differences in growth and that infants randomized to be fed from smaller~     bottles will grow more slowly that those randomized to larger bottles. Growth patterns of~     formula fed infants will also be compared to those of exclusively breastfed infants.~   "
12522|NCT02893306|"~     The purpose of this study is to evaluate whether the administration of multipotent stromal~     cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes~     progression.~   "
12523|NCT02893293|"~     The goal of the project is to evaluate osteonecrosis before and after decompression surgery~     with ferumoxytol-enhanced MRI.~   "
12524|NCT02893280|"~     ACSSLAP is the first island wide audit project in Sri Lanka on ACS.~   "
12525|NCT02893267|"~     Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke~     survivors. HSP is associated with poor rehabilitation outcomes, including interference with~     activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for~     HSP have been proposed, most do not result in long-term relief of pain.~      The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for~     the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular~     electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic~     review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only~     treatment to provide long-term relief of pain for those with HSP. However, physical therapy~     (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment~     for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the~     clinical community, the superiority of PNS to a course of PT must be demonstrated. The~     investigators completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants~     experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT,~     respectively. Thus, the primary objective of this 2-site RCT is to confirm the findings of~     this preliminary pilot RCT. Combining PNS and PT, which may be how PNS is actually~     implemented in clinical practice, may have a synergistic therapeutic effect. Thus, the~     second objective of this RCT is to determine if multimodal treatment of HSP with PNS + PT is~     more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be~     explored.~   "
12526|NCT02893254|"~     Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with~     ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to~     one or more nonsteroidal anti-inflammatory drugs (NSAIDs)~   "
12527|NCT02893241|"~     This is a national, multicentre, prospective, open, two-arm, non-interventional study with~     hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine~     after occurrence of perioperative hypotension, wherein the patients are assigned to a~     treatment arm based on the department.~   "
12528|NCT02893228|"~     Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an~     incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local~     anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline~     in this anatomical location prior to performing an interscalene block the incidence of~     phrenic palsy will be reduced.~   "
12529|NCT02893215|"~     The primary aim of the present study is to screen high-risk type 2 diabetes patients and~     heart failure patients without any history of atrial fibrillation (AF), ongoing oral~     anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack~     (TIA), for silent AF.~      Moreover, we aim to establish the prevalence of two or more risk factors for stroke in~     patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the~     feasibility for this group to undergo AF screening.~      Overall, the aim of the study is to prevent stroke in high-risk patients groups through~     identification of silent (asymptomatic) atrial fibrillation.~   "
12530|NCT02893202|"~     The purpose of the research project was to assess changes in Posttraumatic stress disorder~     [PTSD] symptoms, quality of life and participation of combat veteran who participate in~     equine assisted activities [EAA]. The study used a mixed-methods, waitlist-controlled,~     repeated measures trial of a standardized 8-week therapeutic riding intervention for combat~     veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans~     meeting inclusion criteria were selected to participate in either the intervention group or~     the control/waitlist group.~   "
12532|NCT02893176|"~     Potential therapy with MACITENTAN in the treatment of Chronic Lung Allograft Dysfunction~     (CLAD) after Lung Transplantation. Pilot Study, Double-blind, ADD-ON Therapy with~     MACITENTAN to usual standard of care immunosuppressive therapies after lung~     transplantation for established BOS Stages I or II versus a matched control group who~     receive usual standard of care immunosuppressive therapies alone, results in a decrease in~     the Primary Endpoint: rate of decline in Forced Expiratory Volume-1 sec (FEV1) versus~     time while Secondary Endpoints including: differences in Six minute walk distance (6MWD),~     BORG Score, corrected single-breath diffusing capacity (DCO corrected) at time intervals of~     1, 3, 6 months on therapy. Specific biomarkers for BOS, including inflammatory chemokines,~     which are routinely collected in the context of post-transplant surveillance will be~     analyzed. Chemokines which our group has previously described in the pathogenesis of the~     continuum of acute-to-chronic lung allograft rejection, have included both C-C (CCL2,~     CCL5) and CXC (CXCL9, CXCL10, CXCL11) chemokines as determined in bronchial-alveolar lavage~     (BAL).~   "
12533|NCT02893163|"~     The primary purpose of this trial will be to test the effectiveness of CHANGE intervention~     to increase physical activity, improve diets, reduce obesity and reverse Metabolic Syndrome~     among adult patients identified as at risk for cancer due to diet and physical activity~     behaviours when implemented in typical primary care settings within the Alberta context.~   "
12534|NCT02893150|"~     Mindfulness has been applied in the United States and Europe to improve both physical and~     psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its~     lack, may also have particular relevance to obesity and eating disorders, reducing the~     episodes of binge eating, which are partly responsible for weight regain for many people,~     and improving the eating behavior in order to promote awareness of emotional states which~     distort the physiological signals generated by the process. The hypothesis is that~     Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious~     eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a~     sustainable fashion, improve biochemical, psychometric and anthropometric parameters in~     primary care patients with overweight.~   "
12535|NCT02893137|"~     The present study proposes a new and potentially superior clinical approach to Optune™~     therapy of selected glioblastoma patients. The approach is based on combining TTFields with~     targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr~     holes, designed for the individual patient. Pre-clinical modeling results suggest that such~     procedures may enhance the induced electrical field strength by up to ~100% and thereby~     potentially improve the clinical outcome of treated patients to a significant extent.~      The study is an open label phase 1 clinical pilot experiment designed to investigate~     feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of~     glioblastoma will be included in the trial. All patients will receive TTFields therapy with~     targeted craniotomy and best physician's choice chemotherapy.~   "
12536|NCT02893124|"~     HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of~     drug resistance or suboptimal/partial virological response were enrolled. After giving~     informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and~     weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80~     micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with~     weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80~     micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).~   "
12537|NCT02893111|"~     Neuromyelitis Optica Spectrum Disorders (NMOSD) is characterized by the pathogenic anti-AQP4~     antibody, which can be produced by specific plasma cells. The patients who are not~     responsive to rituximab treatment may be due to the presence of short-lived and long-lived~     plasma cells. Previous studies confirmed that the proteasome inhibitor bortezomib (Velcade®,~     approved for therapy of multiple myeloma) eliminated both plasmablasts and plasma cells by~     activation of the terminal unfolded protein response. Treatment with bortezomib may help~     deplete plasma cells producing auto-antibodies. Therefore, the rationale for using~     bortezomib in NMOSD is in that bortezomib may help eliminate autoreactive plasma cells and~     reduce anti-AQP4 antibodies titers. It is noted that bortezomib may protect astrocytes from~     NFκB-dependent inflammatory damage in early events in NMOSD pathogenesis.~      The purpose of this study is to determine if the drug bortezomib contributes to reduce the~     average relapsing rates (ARRs) and alleviate neurological disability in NMOSD patients.~   "
12538|NCT02893098|"~     A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical~     Trial~   "
12539|NCT02893085|"~     The differential diagnosis between benign and malignant bile duct strictures is a difficult~     and demanding task for clinicians. Clinical, biochemical, and radiological characteristics~     of malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain~     preoperatively. For this reason, there is a need for the development of new diagnostic~     modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by~     tumor cells developing in the biliary tract.~      In addition, patient's tumor molecular profile is the basis for selecting personalized~     therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most~     frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7,~     ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS~     mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2,~     MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations.~      It is well established that KRAS and P53 mutations can be detected in bile samples from~     patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the~     pancreas. The main objective is to determine if bile sample analysis from patients with~     malignant biliary stricture may allow to identify tumor mutation profile and determine tumor~     genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial~     Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples.~      Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor~     tissues in a series of 10 patients surgically treated for malignant biliary stricture~     related to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical~     markers, VEGF and MMPs, will be assessed in bile samples obtained during endoscopic~     retrograde cholangiopancreatography in 50 patients with malignant biliary stricture and 50~     patients treated for benign biliary diseases.~   "
12540|NCT02893072|"~     Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy,~     that affect between 1 to 14% of population around the world. The overall purpose of this~     study is to determine the efficacy of individualized medical nutrition therapy (MNT)~     intervention to reduce and control the development of GDM.~   "
12541|NCT02893059|"~     The main objective of this study is to estimate the reporting bias of patients in terms of~     prescripted drug and care consumption by comparing data collected in a patient diary and~     database of health insurance .~   "
12803|NCT02889653|"~     The purpose of this study is to determine the incidence and severity of bleeding~     complications in patients with cerebrovascular and cardiovascular diseases treated with oral~     antithrombotic therapy.~   "
12542|NCT02893046|"~     The main objective of this research is to evaluate a care pathway adapted to different~     category populations at risk of being infected with the hepatitis C virus in order to~     improve both the diagnosis turnaround times and the access to treatment. The aim is to allow~     a quick and effective access to diagnosis and treatment of HCV by strengthening the city~     hospital networks, access to early consultations and coordination of medical social actors.~   "
12543|NCT02893033|"~     The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to~     2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS~     conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional~     outcome swallowing scale (3 scales). 3. MEP measurements~   "
12544|NCT02893020|"~     Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this~     study is in particular to investigate if this is the consequence of performing surgery (i.e.~     invasive procedures) or whether it is related to the cultural background of surgeons.~   "
12545|NCT02893007|"~     Family interventions have been emphasized in the treatment of BPD and have benefits for~     patients' symptoms and health; however, the effects of family interventions on family~     function and caregivers' health-related outcomes have not been well investigated. This~     randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at~     a medical center in northern Taiwan compared the effects of a brief family-centered care~     (BFCC) program with treatment-as-usual (TAU). The findings support both the feasibility of~     using the BFCC program for inpatients and its specific benefits for family function. An~     intensive family intervention during hospitalization has been suggested in psychiatric~     practice to support patients with BPD and family caregivers.~   "
12546|NCT02892994|"~     This study will compare ultrasound 0.4 W/cm^2 and 100% duty cycle versus no ultrasound~     (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied~     for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the~     subject and ultrasound operator will be blind to the dose. The outcome measures will be~     pressure pain threshold on both masseter muscles and both temporalis muscles, self reported~     pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles,~     and intraoral temperature. These outcome measures will be taken before and after each dose,~     so three times per subject.~   "
12547|NCT02892981|"~     Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion~     mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension~     patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic~     and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two~     components, alveolar and dead space ventilation.~   "
12548|NCT02892968|"~     Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars~     to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases~     suffer a complication known as delirium, or acute confusion. Patients with delirium may~     become frightened and agitated. This in turn leads to other serious problems. Having~     delirium doubles the chances of dying or can increase the need for admission into a nursing~     home. People with delirium spend an extra week in hospital on average.~      Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain~     almost immediately, and use of this technique is known to reduce delirium when administered~     by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients~     with hip fractures commonly wait hours or even days in the Emergency Department (ED) prior~     to their operation. Currently, these patients are given narcotic pain killers like morphine~     to dull their pain, as most ED physicians have not been trained in using this 'freezing'~     technique and Anaesthetists are rarely able to leave the operating room to administer~     freezing to patient in the ED.~      The EDU-RAPID study will test whether training ED physicians on how to use the nerve~     freezing technique will reduce the number of patients who develop delirium after a hip~     fracture. To study this, ED physicians will be trained at 6 hospitals in small groups every~     6 weeks over 18 months. The study will look at how patients who are treated by ED physician~     who has been trained compare to patients treated by a ED physician who has not yet been~     trained. Also, the study will see if the training motivates ED physicians to use the block~     regularly.~      If correct, this study could significantly improve the comfort, quality of life, and~     independence of patients who suffer a hip fracture. In addition, if the study shows a~     reduction in delirium rates, this could represent a significant cost reduction to the health~     care system.~   "
12549|NCT02892955|"~     The objective of the study is to continue to evaluate safety and clinical performance of the~     HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following~     completion of enrollment in the the MOMENTUM 3 IDE Study.~   "
12550|NCT02892942|"~     To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while~     maintaining large oocyte availability, investigators elaborated an innovative protocol~     (NATural Ovarian Stimulation) that dissociates E2 production from multiple follicle~     development.~      The purpose of this prospective, randomized trial is to demonstrate that, in a good~     prognosis IVF-ET population, the physiological E2 environment resulting from NATOS~     significantly improves IVF-ET outcome when compared to the conventional GnRH antagonist~     protocol.~   "
12551|NCT02892929|"~     This randomized clinical trial was designed to test the effectiveness of Motivational~     Interviewing in lowering blood pressure during six months follow-up.~   "
12552|NCT02892916|"~     Postoperative delirium is a frequent complication of major surgery and affects 10% to 70% of~     surgical patients > 60 years. Delirium is associated with increased morbidity and mortality,~     prolonged recovery, functional and cognitive dysfunction with nursing home or long-term care~     facility placement. The acute deterioration in cognition and psychomotor agitation~     frequently seen with delirium is often distressing for both patients and their relatives.~     The pathophysiology and causal relationship between delirium and persistent postoperative~     cognitive dysfunction remain incompletely understood. Identified clinical risk factors for~     both include advanced age, type of surgery, preexisting cognitive impairment, and drug~     addiction. The inflammatory response triggered by surgical trauma and pain may contribute to~     the development of delirium and cognitive impairment after surgery.~      Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia~     and postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on~     neuronal and microglial brain cells, it contributes to tone down the neuroinflammatory~     process associated with surgery. A recent body of evidence has shown that ketamine reduces~     the depressive-like behavior induced by inflammatory or stress-induced stimuli in mice.~     Ketamine was also found to reduce by 28% the absolute risk of postoperative delirium and~     levels of inflammatory biomarkers in cardiac surgical patients.~      Orthopaedic surgery is a high-risk situation for developing postoperative delirium. In~     patients undergoing total hip or knee replacement, the prevalence (incidence, respectively)~     of delirium is 17% (12-51%, respectively) and it is associated with a 6-fold increase~     increased risk of developing dementia and cognitive dysfunction after surgery. Hundred~     thousands of patients > 60 years undergo elective orthopaedic procedures per year around the~     world. The purpose of the study is to assess the superiority of ketamine at subanaesthetic~     dose versus placebo to reduce the incidence of postoperative delirium in patients aged ≥ 60~     years undergoing elective orthopaedic surgery under general anaesthesia.~   "
12553|NCT02892903|"~     A randomised controlled trial to compare two strategies for the investigation of coronary~     artery disease at the time of angiography. Patients will be randomised to conventional~     angiography or additional, routine pressure wire assessment - measuring fractional flow~     reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow~     percutaneous coronary intervention (PCI) (experimental arm).~   "
12554|NCT02892890|"~     Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy~     characterized by an inflammatory multifocal segmental demyelination. Due to the clinical~     heterogeneity of this condition and the lack of specific marker that can reliably identify~     all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors~     predicting the evolution or the prognosis of the disease. Current treatments are the~     intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the~     most commonly used. Responses of the patients to the treatments are variable. Thus, it is~     necessary to identify predictive markers of the therapeutic response of CIDP patients~     treated by IVIg.~      Several potential biomarkers have been proposed recently, but none of them has yet been~     validated as a predictive criterion for therapeutic response. It is therefore necessary to~     continue to investigate several biological parameters to identify a reliable biological~     marker.~      In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the~     axonal loss by a precise count of functional motor units. This method, more sensitive than~     the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX~     might be a good tool to better characterize the patients and to follow the course of CIDP.~     It also might be a new sensitive and reliable marker predictive of the therapeutic response.~      Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular~     diseases. A recent study on CIDP patients reported a significant decrease of the muscle~     Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical~     parameters. The use of advances MRI techniques could allow characterizing the structure and~     composition of muscle and nerve tissues of CIDP patients. It could also be a mean for~     identifying potential new markers, largely unexplored until now, that might be sensitive to~     disease course and/or IVIg response.~      The objective of this study is to identify predictive markers of the treatment response of~     CIDP patients receiving IVIg.~      This is a prospective observational exploratory study of a cohort of 30 CIDP patients~     treated with IVIg and followed-up during one year.~   "
12555|NCT02892877|"~     The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by~     registering, monitoring and treating women with GTD since november 1999. The aim is to~     improve the management of trophoblastic disease in France.~      About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy~     and surgery.~      The center works as follow, based on a multidisciplinary approach. The policy is that~     patient remains followed by her local physician, but can be seen and treated in the Center~     at demand and that the registry is done on a voluntary basis.~      Each administrative french area has a local expert team (oncologist and gynaecologist) who~     is able to look after the patients with the help of the national reference center physicians~     based in Lyon.~        -  Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement~          of his patient, for an opinion, an advice or simply to report the case.~        -  The center sends to the doctor the informed consent form to be signed by the patient, a~          registering form and information about pathology for patient and physician, and first~          guidelines based on initial pathology report.~      The patient remains followed by her gynecologist, who stays her first interlocutor~     throughout the whole process and she goes to her local laboratory for hCG monitoring;~        -  A letter is sent to the initial pathology laboratory that originally carried the~          diagnosis of molar pregnancy to require slide sending to the pathologist referral~          center (9 experts with a specific pathologist national network) that centrally review~          initial diagnosis.~        -  In the mean time, the data manager collects weekly hCG values to establish a follow-up~          chart. The physician is regularly informed by mail of the hCG evolution.~        -  The local physician is contacted in case of modification of the diagnosis by the~          pathologist expert. The center informs him about length and monitoring methodology.~        -  Emails or letters are sent at each step of the management (at inclusion, at hCG~          negativation, and at the end of hCG follow-up).~        -  In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if~          a neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT),~          physician is immediately contacted by phone or email by referent gynaecologist. A~          complete work up including pelvic US with Doppler, pelvic MRI, thoraco-abdominal~          CT-scan with chest radiography if pulmonary nodules are present and brain MRI, is~          planned to determine the adequate treatment.~      Very briefly, based on imaging results, FIGO stade and score are calculated to determine the~     risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is~     started in case of high-risk disease.~      The investigators have developped specific expertise at key levels of diagnosis, management,~     follow-up, fertility preservation and treatment.~      Assignments :~        -  Registration and monitoring post diagnosis of complete or partial molar pregnancy,~          choriocarcinoma,PSTT, ETT, atypical placental site nodules~        -  Histopathological analysis and genetics services~        -  Measurement of human chorionic gonadotrophin (hCG) isoforms~        -  Complex gynaecological surgery~   "
12556|NCT02892864|"~     Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear~     lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is~     a frequent but little-known pathology (20 / 100 000 inhabitants in France a year).~     Oro-facial functions and the ability to convey emotional facial information are seriously~     affected by facial palsy, thereby reducing patient's quality of life. The PFP can have~     several repercussions on the functional, aesthetic, social, occupational and psychological~     levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the~     precocity and the quality of the medical and paramedical care. It is essential to assess~     functional and psychological issues before beginning an adapted global therapeutic care. If~     these depressive symptoms can be explained by multiple factors, the inability to smile would~     be one of the triggering factors of depression. The facial feedback hypothesis could be one~     of many explications because smiling induces a positive emotional state and a feeling of~     well-being. In PFP, patients must cope with their difficulties to smile. Their facial~     behaviour affected their own emotional experiences.~      The main purpose of the present study is to determine if virtual rehabilitation program is~     relevant compared to standard therapy. The second aim is to characterize the efficiency by~     analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A~     secondary objective will be to decrease the functional and social repercussions of the~     facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual~     rehabilitation program will be implemented in an interactive platform.~      To this end, a parallel randomized controlled trial (RCT) of the two groups will be~     conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment~     in which active participation of the patient is necessary so only the assessment will be~     blinded. Facial motor skills (tongue, mouth and face motricity) are measured using~     electronic devices, objective and subjective evaluation with pragmatic fields such as~     communication, emotion and quality of life. The severity of patient's facial paralysis is~     appraised by the House and Brackmann scale. This global assessment will be conducted before~     the beginning of the therapy and every 3 months during 18 months.~      The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a~     baseline assessment. Simple randomization will be used in order to establish both~     therapeutic groups with 45 patients in each group.~      Group A: Patients taken care in consultation within the ENT service which provides~     oro-myo-functional classical rehabilitation.~      Group B: Patients taken care in external consultation who receive oro-myo-functional~     rehabilitation through a virtual rehabilitation program targeted at the smile, in their~     place of living in virtual conditions.~      The patients must have been diagnosed with unilateral peripheral facial palsy, according to~     House and Brackmann international classification.~      Inclusion time : 18 months~      Between-two-groups analysis will be conducted in order to compare a targeted and intensive~     implementation-intention rehabilitation such as virtual rehabilitation program to standard~     therapy. This virtual therapy will consist in repeating mentally movement desired, so that~     it will be more spontaneously executed in the every-day-life situation.~   "
12557|NCT02892851|"~     Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and~     social complications. Cocaine is the second most consumed illicit drug in France. Its~     prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise.~     Craving, the compulsive need to consume, is a key feature of cocaine addiction. It is also~     predictive of treatment efficacy. However, there is no validated treatment for severe~     cocaine dependence yet. Response to current psychological and medical treatment is poor,~     with 73% relapse after 3 months. Patients with severe cocaine addiction are thus in a~     therapeutic deadlock.~      To address these unmet medical needs, the investigators designed a pilot study (n=2) to~     evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei~     (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric~     complication. Indeed, compulsivity is a critical component of craving, and severe~     treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated~     using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of~     STN-DBS in rats addicted to cocaine. Together, these two lines of research suggest a~     therapeutic effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism~     on craving.~   "
12558|NCT02892838|"~     Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to~     relieve pain, restore function and correct deformity. It is a very common surgical procedure~     with figures showing more than 500'000 arthroplasties performed annually worldwide. Total~     knee arthroplasty is considered one of the most successful types of joint reconstruction in~     that surgical results usually meet and even exceed expectations. Much of the current~     literature focuses on the issues relating to implant wear as a potential failure mode for~     artificial knee implants. It has been suggested that knee with mobile or rotating bearing~     options, such as the comparative device proposed for this clinical investigation, may~     survive longer than fixed bearing knee designs because of the greater contact surface area~     possible with more congruent components with unconstrained, mobile component design.~   "
12559|NCT02892825|"~     The purpose of the study is to assess the effect of music therapy on anxiety and~     hypertension during cataract surgery procedures performed under topical anaesthesia.~   "
12560|NCT02892812|"~     The purpose of this study is to evaluate the safety and immunogenicity of LBVE013~     (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014~     (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.~   "
12561|NCT02892799|"~     This is a research study about monitoring diuresis in acute respiratory failure. Often,~     patients with respiratory failure have fluid building up in the lungs, which means less~     oxygen can reach the blood stream, which deprives the organs of oxygen. Managing the amount~     of intravenous fluids is crucial to the treatment of respiratory failure. Diuresis, the~     increased formation of urine by the kidney, is one way that fluid balance is maintained.~     Previous studies of respiratory failure suggest that diuretic therapy may be beneficial in a~     group of patients with Acute Respiratory Distress Syndrome, (ARDS), which is a severe type~     of respiratory failure. Although protocols exist for managing fluid status in ARDS, all of~     them require invasive monitoring using a central venous catheter. This study will compare~     central venous catheter-guided diuresis to ultrasound-guided diuresis. Participants in this~     study will be randomized into one of three treatment arms:~        -  Fluid and Catheter Treatment Trial-lite (FACTT-Lite) diuresis arm~        -  Echocardiography diuresis arm~        -  Central venous pressure CVP diuresis arm This research study will assess differences~          in clinical outcomes, number of ventilator free days, ICU free days, 60 day mortality,~          and incidence of acute kidney injury or new shock between the three treatment arms.~   "
12562|NCT02892786|"~     The dissemination of individual tumor cells is a common phenomenon in solid cancers.~     Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic~     situation is of high prognostic significance.~      The objective of our study was to detect circulating tumor cells in two different method in~     patient with head and neck squamous cell carcinoma .~   "
12574|NCT02892630|"~     The pregnancy may activate flares of certain autoimmune diseases such as lupus. The~     influence of pregnancy on the evolution of ITP was never studied while this pathology~     affects firstly women old enough to procreate. Also, the influence of ITP on pregnancy (risk~     of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather~     unknown and never studied in a prospective study. The realization of a prospective study to~     answer these questions is necessary to allow us to inform better the patients affected by~     ITP and to define better in this context the strategy of supervision of the mother, the~     foetus and the newborn. The highlighting of risk factors of ITP flare or obstetric or~     neonatal complications will indeed allow the implementation of prevention measures.~      The conclusions of this study will allow us to adapt national guidelines for ITP during~     pregnancy.~   "
13700|NCT02877953|"~     The investigators conducted a randomized controlled trial to describe if multidisciplinary~     and patient-centered transitional care interventions for patients with cirrhosis post-TIPS~     can improve compliance behavior and reduce complications post-TIPS after discharge.~   "
12563|NCT02892773|"~     The purpose of this study is to better understand how air is spread throughout study~     participants' lungs after abdominal surgery by comparing two lung inflation treatments:~        1. Incentive Spirometry (I.S.) lung expansion therapy~        2. EzPAP® lung expansion therapy.~      Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths~     after surgery helps lungs to stay inflated. At the University of Virginia, it is at the~     physician's discretion as to which treatment will be used to help with deep breathing lung~     inflation therapy after surgery. The investigators would like to know which of the lung~     inflation therapies is better at helping inflate participants' lungs.~      The investigators will be using a device called Electrical Impedance Tomography (EIT) to~     measure how effectively air spreads in participants' lungs. This device is not currently~     approved by the Food and Drug Administration (FDA) for the purpose used in this study, and~     therefore, it is considered investigational.~      Investigators are inviting eligible participants to consider participating in this study~     because doctors order Incentive Spirometry as a standard of care following upper abdominal~     surgery. Information gained from monitoring how air is spread throughout participants' lungs~     will help investigators to determine if there is a clinical difference and benefit when~     comparing Incentive Spirometry and EzPAP lung expansion therapies.~   "
12564|NCT02892760|"~     The purpose of this study is to develop a clinical algorithmic-based evaluation and~     treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to~     stroke.~   "
12565|NCT02892747|"~     The intervention tested in this research project aims to reduce the unplanned~     hospitalizations in CHF patients by preventing the malnutrition using a personalized~     dietetic education program. This new program provides concrete solutions to patients by~     offering balanced menu ideas, adapted to their tastes and social-cultural habits, and a~     panel of recipes easy to make, inexpensive and tasty (despite the lack of salt). This new~     educational program should improve the dietary behavior of patients and reinforce the~     importance of dietary guidance in support of the CHF.~   "
12566|NCT02892734|"~     The purpose of this research study is to look at the efficacy (the effect on tumor) and the~     safety (the effect on body) of the study drugs when given as a combination in patients with~     metastatic recurrent epidermal growth factor receptor 2 (HER2) negative inflammatory breast~     cancer. This is a phase II study of 2 drugs used in combination: nivolumab and ipilimumab.~     The combination of these drugs is already approved by the Food and Drug Administration (FDA)~     to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are not~     approved by the FDA for patients with metastatic recurrent HER2 negative inflammatory breast~     cancer, hence the treatment is considered experimental or investigational.~   "
12567|NCT02892721|"~     Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20~     individuals, half of whom will die from the disease. Late presentation of CRC has a poor~     prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate~     and early diagnosis of CRC is therefore crucial. In most patients this is achieved via~     colonoscopy, a camera test which is widely available and allows tissue samples to be taken~     of any abnormalities seen during the procedure. However, a non-invasive alternative is~     Computed Tomography Colonography (CTC) which uses X-rays to produce images of the large~     bowel which are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis~     of CRC (comparable to colonoscopy) and the cancer precursor - adenomatous polyps.~      Unlike colonoscopy, however, there is no accreditation process for CTC and there is no~     infrastructure to ensure that all reporting Radiologists are able to do so adequately and,~     as a result, there is a wide range of diagnostic accuracy. There are no universally-accepted~     standards to monitor quality or assess diagnostic performance, partly because we do not know~     what the quality markers are and there is currently no system to quantify them. Overall,~     this contributes to low cancer detection rates, missed cancers and inequity for patients~     across the National Health Service (NHS).~      This study aims to assess the impact of a structured training programme with assessment and~     feedback on NHS radiologist performance. If the impact is positive and results in~     significantly improved performance, then such a scheme could be adopted into an~     accreditation programme for CTC in the English Bowel Cancer Screening Programme (BCSP).~   "
12568|NCT02892708|"~     The objective of this study is to evaluate the efficacy and safety of surgical resection in~     elderly patients 70 years or older with a supratentorial glioblastoma de novo. The~     sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of~     malignant glioma in the elderly will also be studied.~   "
12569|NCT02892695|"~     The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients~     who are going to receive stem cell transplantation but without available treatment to~     achieve complete remission prior to the transplant.~   "
12570|NCT02892682|"~     Previous studies reported infraclinical modifications of the homeostasis in chronic~     urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to~     compare groups with isolated wheals, isolated angioedema, combination of both and hereditary~     angioedema in terms of coagulation pathways.~   "
12571|NCT02892669|"~     This study is designed to evaluate the predictive value of heart rate variability on medial~     outcome in patients admitted to the intensive care department~   "
12572|NCT02892656|"~     The purpose of this study is to determine the reliability of the Oswestry disability index~     (ODI) Numerical Rating Scale (NRS), Pain Self-Efficacy Questionnaire (PSEQ) and the Major~     Depression Inventory (MDI) in a chronic low back pain (CLBP) population referred to The~     Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.~   "
12573|NCT02892643|"~     Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with~     esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract~     reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin~     should be negative for malignancy with intraoperative frozen biopsy.~      Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with~     esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc~     lymph node dissection is mandatory. Resection margin should be negative for malignancy with~     intraoperative frozen biopsy.~   "
12614|NCT02892110|"~     Marijuana is the most commonly used illicit drug. There is high demand for effective~     interventions for cannabis use disorder, yet few specific treatments for have been~     developed. This study will evaluate the efficacy of varenicline for reducing marijuana use~     in people who use marijuana frequently.~   "
12575|NCT02892617|"~     Low back pain is one of the most frequent reasons for consultation in rheumatology. There is~     a strong correlation between low back pain, and the presence of a type of Modic 1 signal on~     MRI.~      The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on~     T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the~     endplates after gadolinium injection; it corresponds to a replacement of normal cancellous~     bone of fibrovascular tissue.~      The origin of this inflammatory process Modic 1 into the vertebra is still unknown.~      infectious hypothesis was raised, including contamination by germs called slow-growth such~     as Propionibacterium acnes (PA).~      Many studies interesting Bacteriological analysis of disc material found the presence of~     bacteria (prevalence between 0 and 54%).~      A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo~     in low back pain with Modic 1; a show effectiveness of this treatment on the different~     clinical parameters evaluated.~      However skin contamination is not formally excluded, particularly in patients previously~     infiltrated (including epidural).~      Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc~     disease, and the possible presence of PA or other slow-growing bacteria in samples obtained~     discal posterior approach would be related to intraoperative contamination or during~     preoperative spinal infiltrations The main objective is to assess the prevalence of germs~     slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in~     type 1 Modic.~   "
12576|NCT02892604|"~     A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide~     scale outpatient trials. Denominated as inControl , it includes improved user interface and~     communication modules while closed-loop algorithms remain similar. During this pilot study,~     the investigators will evaluate this new version of AP for a two-week period during which~     the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the~     clinical team with the new system and collect patient opinions on system acceptance from~     questionnaires. If this trial is conclusive, a randomized 6-month multicentre study~     including 240 patients will be initiated. A total of 5 patients will be included in this~     training study over a 4-week period.~   "
12577|NCT02892591|"~     This study investigates the ability of cannabis to reduce chronic back and neck pain and to~     reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone~     and a placebo.~   "
12578|NCT02892578|"~     Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic~     screening with electrocardiogram could improve atrial fibrillation detection. No studies are~     available in nursing home. The goal of this study is to screen atrial fibrillation in~     patients who live in nursing home.~   "
12579|NCT02892565|"~     The purpose is to determine the hypercoagulable phenotype by thrombinography associated to~     an increased risk of symptomatic and objectively confirmed first venous thrombotic event.~     This is a case-control study in a population with patients having systemic lupus~     erythematosus (SLE) and/or antiphospholipid antibodies (APL).~      Secondary purposes are:~        1. To determine the frequency of hypercoagulable phenotype in study population;~        2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype~          threshold on the importance of risk;~        3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency~          in different groups.~   "
12580|NCT02892552|"~     Objective: To evaluate the diagnostic concordance between multislice computed tomography~     (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of~     patients after cochlear implantation.~      Study Design: Prospective, randomized, single-center, interventional, pilot study on the~     diagnostic performance of a medical device.~      Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan~     after cochlear implant surgery.~      Interventions: Nine patients were implanted with electrode arrays from three different~     manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed,~     and 2 experienced radiologists blinded to the imaging modality evaluated the randomized~     images, twice.~   "
12581|NCT02892539|"~     The purpose of this study is to evaluate the radiation exposure in patients undergoing~     coronary angiography, and to identify reference values for the main radiation doses~     parameters.~   "
12582|NCT02892526|"~     The purpose is to determine intrinsic properties of various immunohistochemical markers~     (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound,~     alone and in association (evaluation of sensibility with surgery wounds and evaluation of~     specificity with post-mortem wounds).~      Secondary purposes are to measure the minimum time to obtain a positive labeling in vital~     wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different~     markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.~   "
12583|NCT02892513|"~     Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain~     management regimens. However, they come at a cost with profound impacts on gastrointestinal~     motility, respiratory depression, and even long-term dependence. Stimulating the external~     ear with cutaneous electrical current is similar to acupuncture and could help improve~     postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN,~     USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used~     with success in treating opioid withdrawal and in animal studies has shown increases in pain~     thresholds. The investigators propose a prospective, randomized, placebo-controlled,~     double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain~     and reduces opioid requirements for patients undergoing elective colon surgery.~      pain perception in post-operative patients may be modulated via the auricular branch of the~     vagus nerve. This has the potential to reduce the use of opioid medications, which will in~     turn reduce the incidence of postoperative ileus and reduce patient need for and dependence~     on narcotic pain medications. This would have an enormous economic impact due to decreased~     length of hospital stays for patients who undergo abdominal surgery. In addition, opioid~     reduction could potentially lessen the national crisis of opioid addiction.~   "
12584|NCT02892500|"~     This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high~     ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.~   "
13701|NCT02877940|"~     The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in~     terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation~     undergoing elective surgical procedure.~   "
12585|NCT02892487|"~     Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation~     indications have risen over the last decade, leading to a significant loss of quality of~     life for patients. Recently, many retrospective studies and two evidence-based and~     systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a~     trend toward benefit for a preventive swallowing exercise program.~      The main hypothesis of this study is that an early active swallowing therapy can improve the~     Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.~      The study will be a randomized controlled, open-label, multicentric phase III clinical trial~     comparing early active swallowing therapy versus non specific swallowing management (usual~     care).~   "
12586|NCT02892474|"~     The purpose of the study is to find out if hybrid coronary revascularization (HCR) and~     coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination~     of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical~     procedure to open up clogged heart arteries.~   "
12587|NCT02892461|"~     This study aims to determine whether umbilical cord milking can improve iron related health~     outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord~     milking, while the other half will receive routine clinical treatment and care.~   "
12588|NCT02892448|"~     There may be a relationship between heart function and the metal ION levels in patients~     having undergone total hip replacement. The idea is to use results from a clinical cardiac~     MRI to assess heart function in a sample of 20 patients whom have also undergone~     metal-on-metal hip replacement to determine whether having undergone this procedure may be~     impacting heart function. In addition to the clinically used parameters, the images will~     also be retrospectively assessed using special software to assess amount of fibrosis and~     early changes affecting cardiac muscle contraction which may be indicative of impaired heart~     function. With these values we will compare to known, and previously collected, hip~     replacement and function data to determine whether there is any differences in how the heart~     works in those having had a hip replacement relative to a normal population.~   "
12589|NCT02892435|"~     Comparison in abdominal wound healing after contaminated or dirty surgery with incisional~     negative pressure wound therapy versus standard dressing.~   "
12590|NCT02892422|"~     To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.~   "
12591|NCT02892409|"~     To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with~     bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,~     clarithromycin, amoxicillin, and lansoprazole.~   "
12592|NCT02892396|"~     This study evaluates the local and systemic inflammatory response in the airway in COPD~     patients who consume electronic cigarettes compared with conventional cigarette smokers.~   "
12593|NCT02892383|"~     The aim of the project is to improve quality of life for multiple myeloma patients in the~     future.~   "
12594|NCT02892370|"~     The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg~     SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the~     pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.~   "
12595|NCT02892357|"~     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to~     investigate the safety, tolerability and efficacy of Jianpi Qinghua granule combine and Low~     dose omeprazole in patients with non-erosive reflux disease (NERD)~   "
12596|NCT02892344|"~     The purpose of the trial is to evaluate efficacy and safety of QMF149 150/80 microgram o.d.~      delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms~     of lung function and symptom control in poorly (ie inadequately) controlled asthma patients.~     This study will assess contribution of LABA as an add-on therapy to low dose ICS~     monotherapy.~   "
12597|NCT02892331|"~     African Americans are at a substantially greater type 2 diabetes risk compared to~     Caucasians; however, very little data are available on the effects of exercise training on~     type 2 diabetes risk factors in at risk African Americans. The present proposal will~     evaluate the effects of 6 months of moderate versus vigorous intensity aerobic exercise~     training on fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle~     oxidative/insulin sensitivity markers, adiposity, and quality of life in African Americans.~   "
12598|NCT02892318|"~     This is a non-randomized, open-label, Phase Ib study of atezolizumab in combination with~     immunomodulatory agents for the treatment of participants with AML (relapsed-refractory and~     treatment-naive, elderly participants unfit for induction chemotherapy). The study has been~     designed with the intent, over time, to study multiple combinations of atezolizumab with~     different immunomodulatory agents in AML participants (e.g., umbrella study design). The~     study will begin with the evaluation of the combination of atezolizumab and guadecitabine~     (Arm A). In the future, additional arms may be added.~   "
12599|NCT02892305|"~     The goal of this study is to evaluate and describe the surgical and overall outcomes of~     subjects who undergo pancreatectomy and hepatic resection/ablation for pancreatic cancer~     with low-volume hepatic metastases, as part of routine care. Subjects will be followed to~     determine operative risks and 90-day morbidity and mortality. In addition, survival outcomes~     will be compared to historical controls who did not undergo surgery. Secondary outcomes will~     include mortality and morbidity; operative time; blood loss and transfusion requirements;~     and oncologic outcomes such as: margin status, lymph node harvest, disease-free survival,~     and overall survival. Analysis of subject and tumor characteristics will help the~     investigator identify subjects who would benefit from this aggressive multimodal approach.~   "
12600|NCT02892292|"~     The objective of this study is to realize the typing of all HLA loci and validate this~     technique with continued optimization of next-generation sequencing technology (NGS).~   "
12601|NCT02892279|"~     The adverse effects of air pollution on cardiovascular and respiratory health have been~     demonstrated in an extensive series of epidemiological, observational and experimental~     studies. In the current project the investigators aim to determine whether an acute exposure~     to diesel exhaust causes impacts on sympathetic nervous system activation in healthy~     volunteers.~   "
12691|NCT02891109|"~     The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells~     produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B~     cells, are known to control other cells. Their action in chronic immune thrombopenia is~     actually unknown.~   "
12602|NCT02892266|"~     This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in~     adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in~     the way adolescent transplant recipients take their prescribed medicine.~      Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver,~     lung, small bowel) transplant recipients and their parent(s)/guardian.~   "
12603|NCT02892253|"~     This Randomized Controlled Trial evaluates the clinical impact of parathyroid~     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy~     (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND)~     with NIR vs without NIR use during surgery.~   "
12604|NCT02892240|"~     In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures~     at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is~     still relevant and in use today.~      Many studies have sought to determine if the treatment had to be surgical or orthopedic.~     Although the standard treatment of displaced fractures of the acetabulum is the reduction~     and osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of~     the acetabulum, impaction of the femoral head or acetabular impaction affecting more than~     40% of the articular surface and including bearing zone. All these treatments and those~     supported have been studied in the literature.~      However the study of the laying of total hip remote trauma after acetabular fracture~     osteosynthesis or treated conservatively, is not rich in literature. Only a few articles~     have been published in recent years.~      Indeed, a recent review of the literature are nearly 11 series focusing on the results~     remotely hip prostheses for treatment of acetabular fracture. These two prospective series~     with between 21 and 63 patients. All authors report rates well above those reported~     complications for primary arthroplasty, with a revision of rates ranging between 0 and~     26.5%.~      Fractures of the acetabulum are covered in our service by one operator using the same~     release technique based on the stiffening. The objective of this study is to determine~     whether the systematic surgical treatment of these patients by an experienced operator~     reduces the high complication rate.~   "
12605|NCT02892227|"~     Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and,~     filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a~     more reliable estimate of the true blood volume the patient and thus lead to a therapeutic~     adjustment more suitable.~      This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30~     days and mortality, less alteration of biological parameters myocardial, kidney and liver.~   "
12606|NCT02892214|"~     The proposed study will evaluate how personality characteristics, cognitive factors and the~     emotional and behavioral responses of patients with provoked vestibulodynia (localized~     provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to~     therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional~     health and sexual functioning.~   "
12607|NCT02892201|"~     This is a phase II study for patients with squamous cell carcinoma of the head and neck who~     have residual disease following definitive therapy with radiation (with or without systemic~     therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of~     radiation therapy. Residual disease must be biopsy proven before the patient can consent to~     the trial, and can be either from lymph nodes in the neck, or from the primary tumor site.~     Prior to beginning study therapy patients are evaluated by an ENT to determine if they have~     disease amenable to surgical resection. Both resectable and unresectable patients will be~     eligible for participation in the study.~   "
12608|NCT02892188|"~     The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a~     physician-pharmacist collaboration.~   "
12609|NCT02892175|"~     The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the~     opportunity for all adults to write advance directives in case she would one day be~     unable to express their will. If this right is enshrined in the hospitalized patient's~     charter, brought to the attention of any patient entering a hospital, the fact remains that~     only 2.5% of the deceased have written advance directives (study National Institute of~     demographic studies published in 2012).~      Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the~     conditions of the end of life are insufficiently discussed with patients and their families~     and can lead to difficult situations conflicting view. Now, thinking about advance~     directives should allow an exchange on the conditions of the end of life desired by~     patients.~      Sicard report of December 2012 concluded that such legislation is known neither patients nor~     doctors. This is the first obstacle to its use, even if major psychological barriers exist~     both in patients that their doctors.~      It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new~     bill on the subject. The bill provides that advance directives will no longer be valid for 3~     years, but until changed or until the patient's death, and they can be invoked against~     doctors except emergency or illegality. In addition, to complete the bill, the Ministry of~     Health commissioned the National Health Authority (HAS) writing a form of advance~     directives, as well as a doctor's information guide and patient on the subject. The working~     group is chaired by Professor Sicard. Among the recommendations made to physicians (and by~     extension health professionals), the investigators accept that talk of advance directives as~     often as possible and as early as possible, even in the absence of commitment in the short~     or medium term prognosis .~   "
12610|NCT02892162|"~     Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial~     due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous~     study indicated that the upper area of the left atrium (LA) plays an important role in~     PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in~     progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators~     therefore hypothesized that AF should not be initiated or sustained if the latter crucial~     regions for AF maintenance are abolished. This study aimed to describe the efficacy and~     safety of additional linear ablation on the left atrial anterior wall for PerAF.~   "
12611|NCT02892149|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance~     treatment of anemia in subjects with DD-CKD~   "
12612|NCT02892136|"~     This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate~     pediatric patients with cardiovascular disease,congenital heart disease in patients of all~     ages, fetuses undergoing clinically indicated MR imaging.~   "
12613|NCT02892123|"~     ZW25, a humanized bispecific monoclonal antibody targeting the extracellular domain of HER2,~     has demonstrated activity in preclinical models of low and high HER2-expressing cancers,~     including ovarian, breast, gastric/ gastroesophageal (GEJ) and non-small cell lung. This is~     a Phase I study to evaluate the maximal tolerated dose (MTD) or optimal biological dose~     (OBD) and overall safety and tolerability of ZW25 in patients with locally advanced~     (unresectable) and/or metastatic HER2-expressing cancers.~   "
12615|NCT02892097|"~     The purpose of this study is to test the effects of three different rehabilitation training~     sessions that combine non-invasive brain stimulation (transcranial direct current~     stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP)~     for individuals with unilateral spatial neglect following stroke. This study is designed to~     determine the effects of tDCS + RTP on the excitability in the brain, attention to the~     affected side, and arm movement ability.~   "
12616|NCT02892084|"~     This project will evaluate two different methods of normalizing the center of mass~     acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern~     of recovery to analyze walking-specific adaptations as precursors to motor learning. In~     addition, the proposed project seeks to establish the optimal configuration of electrodes to~     activate neural circuits involved in post-stroke locomotion. Once the better method of~     training COMa and optimal parameters of electrode placement for tDCS are identified, the~     investigators will evaluate the effects of tDCS on locomotor adaptations during single~     sessions and over a five-day training period.~   "
12617|NCT02892071|"~     Tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing~     the medium depth trichloroacetic acid peel, CO2 laser and Qs-NdYag laser.~   "
12618|NCT02892058|"~     The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee)~     is justified by the opportunities for development of clinical trials targeting hip and knee~     OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment~     of symptoms. Such treatments are currently under development and will likely bring important~     changes in the treatment of patients. The development of a Flare-OA tool would be essential~     to capture the occurrence of flare, and to implement and adapt treatment strategies.~      This project was elaborated with the aims to:~        1. define the construct through development of a conceptual framework~        2. use the conceptual framework to inform the development of a patient-reported outcome~          measure, Flare-OA tool, for people with OA~        3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome~          Measures in Rheumatology) filter 2.0 and Rasch measurement methods.~   "
12619|NCT02892045|"~     A new NMT module from Mindray (Mindray Co. Shenzhen, People's Republic of China.) claims to~     measure 3 directional accelerography. The aim of the study is to compare the neuromuscular~     block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ED95) monitored by the NMT to~     that monitored by the Relaxometer mechanomyograph, and to clinically evaluate the new system~     for its diagnostic accuracy.~   "
12620|NCT02892032|"~     This study aims to examine the effects of smartphone-based Attention-Bias Modification~     Training (ABMT) in chronic pain participants.~   "
12621|NCT02892019|"~     This study is designed to explore lung function effects of two doses of indacaterol acetate,~     75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic~     exposure to indacaterol in plasma with historical data in adults, to identify an appropriate~     dose to Phase III evaluation.~   "
12622|NCT02892006|"~     Managing distress and improving well-being is critically important for optimal survivorship~     care. Treatment of distress leads to better adherence to treatment, better communication,~     fewer calls and visits to the oncologist's office, and avoidance of development of severe~     anxiety or depression. Based on national guidelines, distress is typically managed with~     pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or~     chaplaincy services. To our knowledge, the role of a structured improvisational comedy~     (improv) program in reducing distress and improving well-being has never been evaluated in~     the oncology setting.~   "
12623|NCT02891993|"~     The purpose of this research study is to address the challenge of symptom management for~     hospitalized patients with cancer.~   "
12624|NCT02891980|"~     This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity~     of two heterologous and two homologous prime-boost regimens using MVA-BN®-Filo and~     Ad26.ZEBOV administered in different sequences at Days 1 and 29 in healthy adult subjects~     aged 18 - 45 years.The study will evaluate the 'omics (transcriptomics, proteomics,~     lipidomics, metabolomics), antibodies for immunogenicity, CMI, ADCC, lymphoproliferative and~     plasmablast responses to MVA-BN®-Filo and Ad26.ZEBOV vaccines. The primary objectives of~     this study are: 1) To Assess the safety and reactogenicity of each study group. 2) To assess~     responses to the study vaccination by study group after the first, second and third dose by~     transcriptomics. 3) To assess the peak antibody response to the study vaccination by study~     group to filovirus antigens.~   "
12625|NCT02891967|"~     restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of~     performance and durability of both restorations during one year follow up~   "
12626|NCT02891954|"~     Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers.~     Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after~     administration of the first dose of canagliflozin. A genome-wide association study (GWAS)~     will be conducted to search for genetic variants that are associated with each of the~     pharmacodynamic responses to canagliflozin.~   "
12627|NCT02891941|"~     This exploratory study aims to identify the most promising biomarkers that alone or in~     combination might predict development of mood disorders [i.e., major depression (MD],~     cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment~     following repetitive/mild traumatic brain injury (MTBI).~   "
12628|NCT02891928|"~     The purpose of this study is to determine if the wearing of shoes rocker sole type~     prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of~     equilibrium.~   "
12629|NCT02891915|"~     This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical~     trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in~     children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care~     facilities, and emergency departments. Primary objective is to compare the composite overall~     outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP~     assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient~     beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)~   "
13702|NCT02877927|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to linezolid in the treatment of adults with acute bacterial skin and skin structure~     infections.~   "
12630|NCT02891902|"~     The purpose of this study is to evaluate in a multicentric cluster randomized study the~     effect of the presence of dedicated nurses for training of ICU staff in preventing~     nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used~     as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is~     included with the objective to show a reduction of one third of the rate of ICU-acquired~     bloodstream infections. The study is currently at the end of the recrutimeent phase.~   "
12631|NCT02891889|"~     The aim of this study is to investigate aspects of brown fat in scanner with injection via~     the PET-CT study.~   "
12632|NCT02891876|"~     Biodentine® is a most recent material for direct pulp capping. The aim of this study is to~     determine the 3 months success rate (defined as clinical and radiographic successes~     together) of direct pulp capping realized with Biodentine®.~   "
12633|NCT02891863|"~     The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility~     study that will assess and characterize early safety and effectiveness of low energy~     therapies in converting monomorphic ventricular tachycardias (MVTs).~   "
12634|NCT02891850|"~     To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5~     inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients~   "
12635|NCT02891837|"~     The purpose of this study is to determine whether L-citrulline is effective and safe in the~     prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing~     surgery for congenital heart defects.~   "
12636|NCT02891824|"~     This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess~     the efficacy of atezolizumab in combination with platinum-based chemotherapy plus~     bevacizumab administered concurrent to chemotherapy and in maintenance, in patients~     presenting epithelial ovarian cancer (including patients with primary peritoneal and / or~     fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval >~     6 months).~   "
12637|NCT02891811|"~     This is a randomized, 2-arm phase II, multi-center study to evaluate the overall response~     rate in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy~     with either KTd or KRd followed by randomization to either carfilzomib maintenance treatment~     for 12 months or to observation only. Maintenance is given for 12 cycles or progression of~     disease, whatever occurs first.~   "
12638|NCT02891798|"~     After total joint replacement, early hospital discharge to home (with patients capable of~     continuing a home-based rehabilitation program) is a cost- effective management strategy.~     This project will use improved local anesthetic nerve block techniques to enhance technical~     capability and clinical practice by (i) reducing pain and other morbidities during recovery,~     (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for~     earlier return home, and (iii) continued rehabilitation as an outpatient at home when~     feasible (versus in an extended care facility).~   "
12639|NCT02891785|"~     Background: Significant barriers to cancer pain management are patient-related. So far,~     cancer pain self-management support interventions have only been tested in strictly~     controlled settings of randomized controlled trials (RCT) and thus evidence for comparative~     effectiveness is lacking.~      Methods: This study includes a cluster RCT with a stepped wedge design and a qualitative~     substudy. The aim of the study is to evaluate the implementation of ANtiPain in clinical~     practice. The primary patient-related aim is to improve pain interference with daily~     activities. Secondary patient-related aims are pain intensity, barriers to pain management,~     self-efficacy, and quality of life. Secondary organization-related aims are nurse~     proficiency and satisfaction with cancer pain self-management support, participation rates,~     and implementation fidelity.~      Inclusion and exclusion criteria: On 10 to 13 wards adult oncology patients will be included~     (n=150 pre-, n=150 post-implementation) if they are admitted to one of the participating~     wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular pain medication, able~     to understand German, discharged with pain self-management, and give informed consent.~     Patients with signs of disorientation that may severely limit pain self-management will be~     excluded.~      Interventions: Pre-implementation, patients receive standard care. Post-implementation,~     patients receive ANtiPain which is based on 3 key strategies: information, skills building~     and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone~     calls after discharge. The implementation process will include training of the designated~     staff nurses, case discussions, as well as measures to ensure sustainability of the~     implementation (e.g., training of clinical nurse specialists).~      Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete~     questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be~     collected before implementation and 1 and 3 months after implementation. Data on ward and~     hospital level will be collected at the beginning of the study.~      Statistical analysis: The statistical analysis will be conducted based on mixed models, with~     a random intercept for the respective ward and time as a covariate.~      Qualitative substudy: The qualitative substudy will comprise interviews with head and~     intervention nurses about their views of the implementation.~   "
12640|NCT02891772|"~     Hypotension often happens immediately after anesthetic induction. Particularly in 5-10~     minutes after anesthetic induction it is reported to happen more frequently. Patients may~     have preexisting hypovolemia resulting from dehydration and impaired compensatory responses,~     which increase the risk. However, it is still challenging to assess intravascular volume~     status in spontaneously breathing patients before anesthetic induction. Recently, the~     measurement of corrected flow time in carotid artery was introduced as quite useful, simple~     and noninvasive for the evaluation of circulating blood volume. The aim of this study is to~     evaluate whether corrected carotid artery flow time as determined by ultrasonography in~     spontaneously breathing patients before general anesthesia can predict hypotension after~     induction.~   "
12641|NCT02891759|"~     This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm~     Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal~     matrices (ADM) offered by both vendors and can be used for post-mastectomy breast~     reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm~     Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction,~     these ADMs are used in the same manner. They may be inserted with a tissue expander~     immediately after skin- or nipple-sparing mastectomy. The investigators will examine~     breast-reconstruction associated complication rates, pre- and post-operative patient~     reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital~     costs. The endpoint will be either exchange of the tissue expander for a permanent breast~     implant or autologous flap, explantation due to patient preference, development of a~     complication, or less common reasons. The investigators propose that Cortiva 1mm Allograft~     Dermis and Alloderm RTU will have equivalent complication and patient reported outcome rates~     as well as physician reimbursement, but that direct hospital cost will be less with Cortiva~     1mm Allograft Dermis.~   "
12858|NCT02888938|"~     The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac~     joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and~     2° to quantify structural elementary lesions on MRI and for the first time on CT-scan~     according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis~     (ECHOSpA).~   "
12642|NCT02891746|"~     The aim of the study is to characterize and monitor the microbiome of premature infants born~     in the investigators facility until discharge from the NICU. The investigators will also~     examine the relationship between mode of delivery and the microbiome of the infant, while~     exploring various possible factors that may affect it. In addition, the investigators will~     compare the microbiome of premature infants to the microbiome of term babies born at the~     same time in the same facility.~   "
12643|NCT02891733|"~     Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of~     patients present themselves with a disease diagnosis immediately metastatic non curable.~     Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based~     chemotherapy with or without maintenance therapy. When there is to exhaust this first line,~     a second line treatment is offered to the patient. Three drugs are allowed in this~     situation: docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor~     for epidermal growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually~     standard in first online and in combination with platinum in all patients with non-squamous~     cancer, so that his place is in second line reduced facto). There is no recommendation for~     treatment in third line situation where only erlotinib is allowed.~      Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire~     system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3~     trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and~     non-squamous. The very recent availability in France of the drug under an ATU fact that it~     will most likely become a standard second line, which will tend to place the third line~     docetaxel.~      Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR~     mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does~     not seem appropriate or even harmful. A selection of patients likely to benefit from the~     prescription of EGFR TKI-is essential.~      Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central~     nervous system and the periphery. At the peripheral level, neurotensin is secreted~     postprandial by endocrine cells in the intestinal mucosa and is involved in the motor~     functions of the gastrointestinal tract. The effects of neurotensin pass through the~     activation of three subtypes of receptors which, mainly, NTSR1 and NTSR2 which are receptors~     coupled to G proteins in the extra-digestive normal tissues, including lung, torque NTS /~     NTSR1 n is not expressed physiologically. Rather, this complex is likely to recur in tumor~     tissues.~      The mechanism of this effect is derogatory activation torque NTS / NTSR1 of matrix~     metalloproteinases which causes the release by the cell membrane ligands EGF-like and~     thus, activation of HER receptor (EGFR or HER1, HER2 and HER3). Indeed, in experimental~     tumors created by subcutaneous injection in athymic mouse cell lines adenocarcinomas NTS + /~     NTSR1 + (non-mutated EGFR), treatment with erlotinib - which blocks EGFR pathway - causes a~     significant decrease of tumor growth.~      Expression of the neurotensin receptor in cancer cells metastatic primary bronchial~     adenocarcinoma is not known. Therefore, its pejorative prognostic value is not confirmed in~     the metastatic setting.~   "
12644|NCT02891720|"~     The goal of this study is to evaluate an integrated technology system that confirms~     ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and~     provides visual feedback mechanisms to promote enhanced adherence behaviors.~   "
12645|NCT02891707|"~     This joint research project between the Department of Veterans Affairs (VA) and Department~     of Defense (DoD) will demonstrate that the implementation of the Mobile Device~     Outcomes-based Rehabilitation Program (MDORP) will improve the quality of rehabilitative~     care at a decreased cost to the healthcare system and a reduced burden for service members~     (SMs) and veterans with lower limb loss. The development of the MDORP will be executed by a~     multisite translational clinical care team that will use web-based mobile computing devices~     designed to assess mobility, enable remote prescription of targeted exercise program, and~     provide continual measureable outcomes to document the continuum of care with the intent of~     maximizing prosthetic performance while minimizing adverse medical events. The information~     obtained from this web-based mobile device application will be used by clinicians to promote~     continuity of care from the DoD and VA facilities nationwide to the community and at home.~   "
12646|NCT02891694|"~     Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a~     dystrophy of the basement membrane or following corneal trauma. This syndrome is~     characterized by recurrent episodes of ocular pain more or less associated with localized~     separations between the outer epithelium and the epithelial basal lamina (basement membrane)~     because of anchorage abnormalities between these two corneal layers. This could be the~     result of an increased expression of metalloproteinases cleaving the hemidesmosomes which~     anchor epithelium to the basement membrane.~      The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of~     matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of~     such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3~     in the RCE syndrome.~   "
12647|NCT02891681|"~     To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in~     predicting and monitoring early neoadjuvant treatment response compared to pathological~     response.~   "
12648|NCT02891668|"~     This project has the following primary aims:~      The main objective is to delineate the association between changes in Resting energy~     expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4~     treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid~     patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and~     after 1 year of treatment.~      Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes~     in cognitive function and changes in body composition before and after one year of treatment~     and furthermore changes in insulin resistance following changes in body composition and free~     fatty acids (FFA).~   "
12649|NCT02891655|"~     Corneal stromal thinning observed in keratoconic eyes could result from an increased~     synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by~     an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and~     Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and~     metalloproteinases (MMP) may be observed between the apex of the keratoconus and the~     peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the~     development of specific inhibitors to slow or to stop keratoconus evolution.~   "
12650|NCT02891642|"~     The purpose of the current study is to establish a Liquid biopsy method (positive enrichment~     by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous~     effusions and to evaluate its sensitivity and specificity for clinical application.~   "
12651|NCT02891629|"~     The EyeControl device is an eye movement-based communication device in the form of wearable~     glasses with connected infrared cam-era that tracks the pupil and translates blinks and~     movements into commands.This study is aimed to demonstrate the safety and feasibility of the~     EyeControl device in healthy volunteers, and ALS patients in early stages.~   "
12652|NCT02891616|"~     In the current study, advanced positron emission tomography/computed tomography (PET/CT) and~     positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to~     validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade~     (DICB) therapy, who ultimately achieve clinical benefit, will have an increase, or FLARE,~     in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that~     after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in~     comparison to the patients classified as non-responders. In addition, alterations in tumor~     apparent diffusion coefficient (ADC) on diffusion-weighted magnetic resonance imaging~     (DW/MRI) will be evaluated, expecting after cycle#1: transient reductions in ADC due to~     lymphocyte proliferation, increased cellularity and restriction of water movement in~     responding patients, with these patients tumors having increased ADC at 2 cycles into~     therapy associated with tumor necrosis. This study will evaluate rather early PET imaging~     with FLT and FDG is a useful imaging biomarker of response to DICB.~   "
12653|NCT02891603|"~     The purpose of this study is to examine a new approach to preventing a serious problem after~     transplant called graft vs. host disease (abbreviated as GVHD).~      This is a single-arm, phase II, study of Pacritinib with Sirolimus and Tacrolimus~     (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated~     allogeneic hematopoietic cell transplantation (alloHCT).~   "
12654|NCT02891590|"~     The Primary Objective is to evaluate the safety and tolerability of multiple dose oral~     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.~      The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral~     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.~   "
12655|NCT02891577|"~     This study aims to describe the ratio of the diameter of inferior vena cava to the common~     femoral vein measured by ultrasonography in critically ill patients with shock, and to~     evaluate the potential link between this ratio and the existence of intra-abdominal disease.~   "
12656|NCT02891564|"~     Project:EVO is a video-game based intervention that targets neural networks associated with~     cognitive control. The same networks have been implicated in poor treatment response in~     middle and older aged adults suffering from major depression. Related work has demonstrated~     that healthy older adults show significant improvement in cognitive control. In a very small~     sample of older adults suffering from depression (n=12), we found similar improvements in~     selective attention and working memory after 4 weeks of intervention, along with~     improvements in mood comparable to participants receiving an evidence-based psychotherapy.~     The intent of this proposal is to first determine if at least 2/3 of participants who use~     Project:EVO for four weeks demonstrate significant improvements in the function of these~     neural networks, and if improvements are observed, to conduct a second study to see if~     changes in neural network functions are associated with changes in mood. If we show that~     Project:EVO improves neural function and mood to a greater degree than a placebo cognitive~     training game, we will be in a position to move onto the next phase of study, which is to~     demonstrate the intervention's efficacy in a much larger sample of adults with depression.~   "
12657|NCT02891551|"~     The study design is a prospective, non-interventional, observational single arm study.~      A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites~     in the Netherlands. In all cases, the decision to treat the patient with azacitidine was~     already made prior to the decision to enter the subject into the study.~      Recruitment will continue until end of June 2015, provided a minimum of 150 patients have~     been included in the study. When this date is reached, all patients on azacitidine will~     continue to be followed until the last patient enrolled has been followed for 12 months.~   "
12658|NCT02891538|"~     This will be a randomized, controlled pilot trial of patients with histological~     documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not~     received any treatments for cancer. If patient is a candidate for surgical resection, with~     no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects~     will be consented prior to surgery.~   "
12659|NCT02891525|"~     In this study, the investigators aimed at evaluating the role of sweet taste receptors in~     the gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or~     acesulfame-K were compared with placebo administration for their effects on gastrointestinal~     motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and~     insulin) and hunger feelings.~   "
12660|NCT02891512|"~     The purpose of the study is to determine the effectiveness of the treatment with very low~     frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated~     signs such as sensitivity disorders that affect the first three fingers and half of the~     fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (=~     Xinepa).~   "
12661|NCT02891499|"~     The purpose of this study is to evaluate the effect of Low level laser therapy on stability~     and displacement of orthodontic miniscrew implants using two different force application~     protocols.~   "
12662|NCT02891486|"~     Post-operative wound infections can prolong hospital stays, increase rates of readmission to~     the intensive care unit, and increase the costs of treatment significantly. This study will~     conduct a prospective chart review of all patients undergoing elective spinal surgery on~     both the neurosurgery and orthopedic spine services at two facilities on an academic campus.~     The investigators will collect the data of those patients who develop post-surgical~     infections. This data will then be analyzed and compared to published data from other~     studies. The aim of this investigation is to passively collect this infection data, which~     may ultimately provide needed baseline incidence rates using current and standard protocols.~   "
12663|NCT02891473|"~     The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using~     breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi~     muscle according to the Mézières Method to improve balance and posture and relief pain in~     patients with Parkinson's disease.~   "
12664|NCT02891460|"~     The purpose of this study is to evaluate the clinical response of the tumors within the~     bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at~     that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of~     ureters 6 hr post instillation.~   "
12665|NCT02891447|"~     The goal of this clinical research study is to learn whether cytoreduction surgery (surgery~     to reduce or remove lesions), gastrectomy (where all or part of the stomach is removed), and~     hyperthermic intraperitoneal chemoperfusion (HIPEC, a heated chemotherapy treatment~     delivered directly inside the abdomen during surgery) can help control the disease in~     patients with gastric and/or gastroesophageal cancer. The safety of these procedures will~     also be studied.~   "
12666|NCT02891434|"~     The task consists in reach as much bubbles as they can, the bubbles appear on the screen of~     the computer and should be reached in 10 seconds. To accomplish that, three different~     devices will be used: (1) Kinect for Windows Microsoft - which consists of a sensor that~     captures body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion,~     Inc., San Francisco, CA, USA), and (3) Touch Screen. To describe motor impairments was used~     the Motor Function Measure Scale; Scale Vignos and Scale Egen Klassifikation;~   "
12667|NCT02891421|"~     The project partnered with U.S. military veterans with a premier accredited therapeutic~     riding center for six weeks. The veterans interacted with horses by grooming and learning~     about them, as well as riding them for one hour per week during which they gained a variety~     of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress~     Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and~     emotional health and self-efficacy.~   "
12668|NCT02891408|"~     The primary objective of this study is to evaluate the single-dose pharmacokinetics (PK) of~     GS-0976 in adults with normal hepatic function, and mild, moderate, or severe hepatic~     impairment.~   "
12669|NCT02891395|"~     Open label non-randomized multicenter phase 2 trial with direct individual benefice~   "
12692|NCT02891096|"~     The investigators conducting this study to investigate the relation between the respiratory~     muscle strength and respiratory complications. To understand more about respiratory~     complications the influence of different factors (such as in- and expiratory muscle~     strength, lung function parameters, physical activity, smoking, medications,…) on~     respiratory complications (such as pneumonia) will be investigated.~   "
12670|NCT02891382|"~     This pilot study aims to compare the implementation process of three different interventions~     that use economic incentives to promote lifestyle behavioral changes in patients with Type 2~     diabetes mellitus (T2DM), and to identify barriers and facilitators linked to the process of~     implementing each of the interventions. The interventions are based on economic incentives~     directed to the patient (individual incentives) or a team comprised by the patient and a~     partner (mixed incentives).~      Design: Three-month randomized control pilot study to test the feasibility of implementing~     three types of intervention with economic incentives.~      Setting: Diabetes outpatient clinics from a public hospital in Peru. Population: Subjects~     are eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 -~     70 years of age, (3) have a body mass index between 25 - 39.9 kg/m2, (4) do not have~     blindness or amputations or foot ulcers or are on dialysis, and (6) have the ability to~     provide informed consent.~      To be eligible as a partner for the participant with diabetes, the partner has to (1) be~     between 18 and 70 years of age, (2) not have a physical or mental impairment that does not~     allow him to help the participant to lose weight, (4) be available and committed to~     supporting the participant in achieving their weight loss goals, and (5) be able to provide~     informed consent.~      Outcomes: Feasibility of conducting a three-arm incentives-based pilot study. Secondary~     outcomes: Weight loss, and change in glycated hemoglobin after 3 month.~   "
12671|NCT02891369|"~     The refractory malignant ascites is a complication of advanced stages of many cancer types.~     It is characterized clinically by abdominal pressure sensation, shortness of breath and~     pelvic pain. Thus, it contributes to decreased quality of life for these patients in~     palliative care.~      Conventional treatment is based on paracentesis of ascites. The progression of the disease~     leads to increased production of ascites requiring more frequent paracentesis. Main~     therapeutic alternatives are constituted by the controversial use of diuretics and the use~     of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF):~     bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the~     treatment of refractory malignant ascites showed no sufficient clinical benefit.~      VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and~     capillary filtration surface generating increased protein extravasation. These phenomena are~     responsible for an increase of the volume of ascites product. Thus the use of inhibitors of~     VEGF, such as bevacizumab, could reduce the production of ascites.~      The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on~     small animals in intraperitoneal administration.~      Studies in humans are few and the doses used are not consistent from one study to another.~   "
12672|NCT02891356|"~     The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to~     play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and~     adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to~     explore the relationship in anorexia nervosa patients with change in bone mineral density~     and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in~     180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed~     blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines~     (leptin, adiponectin and Préf-1)~   "
12673|NCT02891343|"~     The early assessment of new symptomatic drugs for Alzheimer disease remains difficult~     because of the lack of predictive end-point. The use of a battery including different~     parameters could improve this early development. In healthy volunteers, to test the reverse~     effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive~     impairment and cerebral activity changes by a challenge test. In this context, a transient~     hypoxia could be relevant.~   "
12674|NCT02891330|"~     The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due~     to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related~     symptoms occur very early after eating (within 30 minutes), are not associated with~     concurrent hypoglycemia, and are most prominent in the early postoperative period. This~     syndrome very debilitating for the patient can be improved by dietary and nutritional~     recommendations. We hypothesize that a personalized approach based on dietary and~     nutritional recommendations conducted by a nurse would likely to decrease the frequency of~     dumping syndrome and improve the postoperative quality of life of patients in the early~     postoperative period.~   "
12675|NCT02891317|"~     The purpose of this study is to assess how surgical interventions in glaucoma affect 24-hour~     intraocular pressure, 24-hour ocular perfusion pressure, optic nerve blood flow, and retinal~     oxygen saturation.~   "
12676|NCT02891304|"~     Hypothesis: ACE tool for colonoscopy and EGD allows for reliable standardized learning~     curves, competency benchmarks, and creation of a centralized database that compares trainee~     performance amongst peers. Trainees receiving quarterly learning curves achieve competence~     in endoscopic procedures at a faster rate (ie less procedures) compared to trainees~     receiving usual feedback on endoscopic performance as established by their respective GI~     fellowship program.~      Aims: To compare the number of procedures necessary to achieve competence in EGD and~     colonoscopy between trainees receiving learning curve performance feedback every three~     months in addition to standard feedback versus trainees receiving annual learning curve~     performance feedback in addition to standard feedback for these endoscopic procedures. To~     demonstrate the feasibility of development and adoption of a centralized database that would~     allow program directors and general GI trainees to generate performance reports in relation~     to national peers to provide real-time targeted performance feedback during training and~     evaluate trainee and GI fellowship program directors predictors of competence.~   "
12677|NCT02891291|"~     Optical coherence tomography is technology widely used in medicine. In this study, the~     investigators will use an optical tomographic scanner to scan skin tissue image.~   "
12678|NCT02891278|"~     This is a Phase I study with the goals of determining the feasibility, safety, and toxicity~     of administering sertraline in combination with timed-sequential cytosine arabinoside~     (ara-C) in adults with relapsed and refractory acute myeloid leukemia.~      Primary objective:~        -  To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of~          sertraline administered in combination with timed-sequential cytosine arabinoside in~          adult patients with relapsed and refractory acute myeloid leukemia.~        -  To evaluate the safety and tolerability of sertraline given in combination with~          timed-sequential cytosine arabinoside in adult patients with relapsed and refractory~          acute myeloid leukemia.~   "
12679|NCT02891265|"~     Tobacco use is the leading preventable cause of death contributing to more than 5 million~     estimated deaths per year globally. The longterm negative effects of smoking are well~     established. Complications due to smoking, from an orthopaedic perspective include impair~     bone and wound healing, and increased risk of infection and osteomyelitis.~      The primary outcome of this research is smoking cessation in patients attending the~     orthopaedic fracture clinic. This is a unique environment whereby previously healthy~     patients are faced with the impact of disability. This impetus to abstain from the benefit~     of fracture outcomes provides an opportunity for previously unattained early intervention~     and thus a greater potential for decreased patient morbidity and mortality. Furthermore it~     is a high volume clinic that, given the unique nature of traumatic injuries consists of a~     high proportion of males, ages 24-34 years old, obliged to follow up. This population is~     traditionally regarded as unattainable from primary prevention smoking cessation strategies.~     The investigators hypothesize that The Ottawa Hospital Fracture Clinic will serve as an~     effective environment to employ established primary prevention smoking cessation~     interventions, reducing the incidence of complications associated with fracture and surgical~     healing, and result in greater long-term cessation rates.~   "
12680|NCT02891252|"~     hemithyroidectomy as a outpatient procedure is performed in some countries, it has never~     been done a RCT whether it is feasible~   "
12681|NCT02891239|"~     This is an open-label, multi-center study. Subjects in this study will receive up to eight~     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm~     wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for~     one follow‐up (FU) visit at the clinic at 8 weeks following the last treatment.~   "
12682|NCT02891226|"~     The purpose of this study is to evaluate the safety and effectiveness of the study drug~     LY3074828 in participants with active Crohn's Disease.~   "
12683|NCT02891213|"~     Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The~     clinical manifestations are severe and affect multiple target organs such as the kidney,~     central nervous system, skin, heart and joints. Despite the progress made in the therapeutic~     approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's~     important to identify new biomarkers to help clinicians to predict severity and evolution of~     the disease for better adaptation of treatments and try to improve the prognosis.~      RAGE (Receptor for Advanced Glycation Endproducts) :~      RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor,~     involved in development of many diseases such as diabetes, chronic renal failure but also in~     vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number~     of crucial cell processes like inflammation, and tissue and cellular homeostasis.~      RAGE is able to bind not only the advanced glycation end products (AGEs) such as~     pentosidine, carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also~     other ligands such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have~     been correlated in recent studies to the activity index of SLE. The activation of RAGE leads~     to a cascade of intracellular signaling and activation of the transcription factor NF-ΚB .~     NF-ΚB enable the traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE,~     these cytokines involved in perpetuation of inflammation and tissue damages including lupus~     nephritis. Moreover, the activation of RAGE induces the expression of adhesion molecule such~     as sICAM -1 and sVCAM -1 wich were recently involved in SLE vasculitis.~      Soluble forms of RAGE, sRAGE and esRAGE :~      RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms,~     esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes).~     esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a~     'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell~     surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an~     anti-inflammatory action. Several studies have shown a decrease in circulating levels of~     sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy~     controls. However, the role of RAGE in SLE remains unknown.~      RAGE and Systemic Lupus Erythematosus, recent advances :~      Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE~     knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic~     manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory~     effect on the lupus nephritis and could be a potent therapy in mice.~      In humans, two studies show a correlation between the plasma level of sRAGE and lupus~     phenotype ( Nienhuis et al. , 2008).~      Working hypothesis :~      Based on the results and those of the current studies, the investigators think that RAGE~     axis and its soluble forms play a crucial role in the complex pathogenesis of SLE.~      The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the~     activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be~     novel biomarkers of SLE and sRAGE a potent therapeutic target.~   "
12684|NCT02891200|"~     The study is to compare the effectiveness of two health communication and dissemination~     strategies that are designed to engage patients and family caregivers in successfully~     managing COPD in 'real-world' settings. Both strategies aim to advance patient understanding~     of COPD, its treatment options, and self-care tasks; support them in coping with the~     disease; and enable them to adopt a variety of positive behaviors, including adherence to~     treatment plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming~     an active, healthy lifestyle. One strategy relies on the healthcare professional (HCP) as~     the primary communicator about COPD self-management (HCP arm), whereas the other uses a dual~     approach that involves both healthcare professionals and peer mentors delivering such~     communication (HCP plus Peer arm). Peer mentors are COPD patients and caregivers who have~     successfully managed COPD and have received foundational training on peer mentoring.~     Specifically, the study aims are to : 1) Conduct a randomized controlled trial in which the~     'HCP' and 'HCP plus Peer' strategies are tested in 'real-world' healthcare settings; 2)~     compare the impact of these strategies on patient satisfaction, experience, activation,~     self- efficacy, self-care behavior, health status, quality of life, use of Emergency~     Department (ED) and hospital services, and survival; and, 3) compare the impact of these~     strategies on caregiver satisfaction, experience, self-efficacy, stress, and coping skills.~   "
12685|NCT02891187|"~     The OPTIONs study is a randomized controlled, non-inferiority study to evaluate~     postoperative care using outpatient clinic visits versus telephone calls for women~     undergoing surgery for pelvic floor disorders. The primary outcome is patient satisfaction~     using the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS)~     questionnaire provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary~     outcomes include safety and cost analysis for patients' direct and indirect medical costs.~     Women who speak and understand either English or Spanish and planning to undergo an elective~     surgery for a pelvic disorder will be recruited. Baseline demographics, satisfaction, and~     cost analysis questionnaires will be acquired pre-operatively. Randomization will be~     assigned at the time of discharge from the hospital. Patients will either have scheduled~     clinic visits at 1-2 weeks, 6 weeks, and 3 months or telephone calls by a registered nurse~     at these same intervals. Questionnaires will be completed at 3 months for satisfaction and~     cost analysis.~   "
12686|NCT02891174|"~     To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in~     women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).~   "
12687|NCT02891161|"~     This is an open label, multi-institutional, single arm study of a phase Ib study, followed~     by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial~     cancer (UC). No randomization or blinding is involved.~   "
12688|NCT02891148|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single~     rising doses of BI 690517~   "
12689|NCT02891135|"~     In its 2015 revision of the global guidelines for HIV care and treatment, the World Health~     Organization called for initiating lifelong antiretroviral treatment (ART) for all patients~     testing positive for HIV, regardless of CD4 cell count. As countries adopt the new~     recommendation, known as treat all, millions of additional patients are becoming eligible~     for ART worldwide. In sub-Saharan Africa, where most of these patients are located, studies~     continue to document high losses of treatment-eligible patients from care before they~     receive their first dose of antiretroviral medications. Among facility-level reasons for~     these losses are treatment initiation protocols that require multiple clinic visits and long~     waiting times before a patient who tests positive for HIV is dispensed an initial supply of~     medications. Simpler, more efficient, accelerated algorithms for ART initiation will be~     needed if treat all is to realize the benefits expected.~      Experts have proposed a simplified clinical algorithm to screen patients for eligibility for~     immediate ART initiation at a patient's first clinic visit, without the use of point-of-care~     laboratory test technologies. The Simplified Algorithm for Treatment Eligibility (SLATE)~     uses four screens to assess whether a patient is eligible for same-day treatment initiation:~     i) symptom report, ii) medical history, iii) brief physical examination; and iv) readiness~     assessment. SLATE is a pragmatic, individually randomized evaluation to determine the~     effectiveness of the algorithm in increasing ART initiation among non-pregnant adult~     patients. Approximately 1,500 HIV-infected adult patients not yet on ART will be enrolled~     during a routine clinic visit and randomized to receive the intervention or standard care.~     Patients in the intervention arm will be administered the SLATE screens; those found~     eligible under the algorithm will be offered immediate treatment initiation, while those who~     are not eligible will be referred for standard clinic care. Patients in the standard arm~     will be referred for ART initiation under standard clinic procedures. All care after the~     initial visit will be by the clinic under standard of care. If successful, SLATE will offer~     a standardized approach to collecting and interpreting a minimum set of patient data that~     will avoid delaying treatment initiation for the majority of patients who are eligible for~     immediate ART, while deferring initiation in the minority who should not start immediately.~   "
12690|NCT02891122|"~     This study aims to determine if prolonged fasting represents an independent risk factor for~     hypotension during induction of general anesthesia in the elderly.~   "
12693|NCT02891083|"~     Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after~     radical resection still carries the risk of recurrence after complete surgical resection,~     especially in some high-risk patients. There are still lack of knowledge on postoperative~     treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of~     recurrence is associated with the location and cell differentiation of primary tumor, as~     well as the presence of lymphovascular invasion. This project is designed to study the~     efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk~     factors of recurrence after radical surgery. We aim to compare the differences among~     adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective~     randomized controlled trial. There has been no similar studies in esophageal cancer~     previously reported with similar design. The results of this study is expected to have a~     high clinical relevance.~   "
12694|NCT02891070|"~     The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr~     for use as an adjunct to sutured dural repair in cranial surgery.~   "
12695|NCT02891057|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
12696|NCT02891044|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
12697|NCT02891031|"~     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known~     as Somagh on serum uric acid levels.~   "
12698|NCT02891018|"~     Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter~     Vasoguard TM in treatment of in-stent restenosis.~      Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM~     Control group: paclitaxel release coronary balloon catheter SeQuent Please~   "
12699|NCT02891005|"~     Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter~     VasoguardTM in treatment of small vessel lesion.~      Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM)~     Control group: common balloon catheter (Maverick2)~   "
12700|NCT02890992|"~     Primary Objective:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age~     of 8 to 17 years, with LDL-C ≥130 mg/dL (3.37 mmol/L) on optimal stable daily dose of statin~     therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in~     case of intolerance to statins for at least 4 weeks prior to the screening period.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the pharmacokinetics profile of alirocumab.~        -  To evaluate the effects of alirocumab on other lipid parameters.~   "
12701|NCT02890979|"~     This pilot clinical trial studies how well a swallowable sponge cell sampling device and~     next generation sequencing work in detecting esophageal cancer in patients with low or high~     grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers~     in abnormal esophageal cells using a swallowable sponge cell sampling device and next~     generation sequencing may improve diagnosis and treatment of esophageal cancer.~   "
12702|NCT02890966|"~     The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic~     properties of multiple dose adminstration of SHR4640 in healthy volunteers.~   "
12703|NCT02890953|"~     The objective of this study is to evaluate the efficacy and safety of a single~     intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage~     (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control~     group.~   "
12704|NCT02890940|"~     The goal of this study is to explore whether facial expression changes in visual portraits~     correlate with Quality of Life (QOL) questionnaire responses before and after pet therapy~     sessions and to compare scores of QOL questionnaires before and after pet therapy.~   "
12705|NCT02890927|"~     The primary objective of the evaluation study is to determine if geriatric co-management is~     superior to standard of care in preventing functional decline in older patients admitted for~     acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology~     units of the University Hospitals Leuven.~   "
12706|NCT02890914|"~     Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound~     (TVUS) upon graduation from an accredited program, although TVUS education in residency is~     not standardized. The objective of this study is to assess for improvement in transvaginal~     ultrasound knowledge among residents after viewing an educational DVD.~   "
12707|NCT02890901|"~     The determinants associated with severe outcome and death from Escherichia coli bloodstream~     infections (BSI) remain poorly understood. The epidemiology of E. coli BSI has recently~     changed dramatically with the global emergence of multiresistant strains producing~     extended-spectrum ß-lactamases (ESBL). Outcome is worse in case of ESBL-E. coli, which may~     be due to the intrinsic virulence of ESBL-E. coli or to a delayed adequate empirical~     antibiotic therapy because of multiresistance. Predicting the severity of an infection as~     soon as the initial clinical assessment is of major importance to provide the best care,~     while limiting unnecessary hospitalizations and costs. Yet, no simple clinical score exists~     to predict the severity of E. coli infections.~      In a translational approach, the investigators will include during a maximum of one year 500~     adults with E. coli BSI hospitalized in 7 hospitals in the Paris area, France. Precise~     clinical data will be collected at inclusion and 28 days after inclusion or upon patient's~     discharge (if before day 28). The primary endpoint of the study is death from E. coli BSI at~     day 28.~      The first aim is to determine risk-factors for death at day 28, including clinical and~     bacteriological factors (determined by WGS) in the era of the global emergence of ESBL~     producing E. coli. The second aim is to determine virulence characteristics of ESBL strains~     both at the genome and phenotypic level thanks to a mouse model of septicaemia, and compare~     them to the clinical data. The third aim, will establish and evaluate a simple clinical~     severity score (named COLISCORE), in order to help clinician evaluate patients' severity~     upon initial clinical evaluation and particularly to detect patients at risk of severe~     outcome. The ultimate goal of this work is to have a clinical impact on patients'~     management, by understanding the determinants of patient severity due to E. coli BSI in the~     context of current major epidemiological changes.~   "
12708|NCT02890888|"~     Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.~   "
12709|NCT02890875|"~     Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated~     bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol~     lock therapy for CLABSI prophylaxis in adult patients on PN.~   "
12710|NCT02890862|"~     Development of reliable and objective evaluation methods is required for natural~     upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool~     for quantitative assessment of multijoint movements.~   "
12731|NCT02890589|"~     To assess strut coverage in patients presenting an acute myocardial infarction and treated~     either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel~     group design.~   "
12711|NCT02890849|"~     The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has~     an important role in guiding for the treatment of immune detection point. At the same~     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the~     information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple,~     rapid, non-invasive means of detection. The project is planned to explore the consistency~     analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to~     detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the~     expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures~     design information. Thus exploring the consistency analysis of PD-L1 expression level~     detected in tissues and pExo,guiding clinical practice of radiotherapy combining with~     immunotherapy.~   "
12712|NCT02890836|"~     Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat~     hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes.~     Second, to explore the prevalence of preeclampsia and preterm delivery in women with~     pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c)~     normal blood pressure before entering the third trimester of pregnancy. Third, to explore~     the influence of lifestyle, gestational weight gain and mental well-being on confirmed~     hypertension and preeclampsia in pregnant women with diabetes.~      Design: A prospective multicentre observational study where approximately 400 pregnant women~     with pre-existing diabetes are offered measurements of office blood pressure (BP) and home~     BP for three days three times during pregnancy as well as when the routinely measured office~     BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and~     home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP~     ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered~     antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension,~     b) white coat hypertension, and c) normal blood pressure before entering third trimester of~     pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible~     side effects of antihypertensive treatment including impaired fetal haemodynamics and lower~     infant birth weight will be recorded. The women will complete food diaries and~     questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate~     the influence of these parameters on hypertension and preeclampsia.~   "
12713|NCT02890823|"~     To characterize the effect of three different doses of vitamin D3 supplementation on serum~     25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing~     antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic~     drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis~     D among Thai patients with epilepsy.~   "
12714|NCT02890810|"~     In this placebo controlled, patient and assessor blinded clinical trial, the investigators~     will administer electroacupuncture vs sham electroacupuncture to patients suffering from~     chronic low back pain, and monitor their symptoms as well as collecting objective outcome~     measures. The investigators objective is to identify predictors of pain reduction and~     functional improvement with electroacupuncture vs placebo.~   "
12715|NCT02890797|"~     Assessment of thoracic echography for pleuroparenchymatous anomaly diagnosis complicating~     bronchiolitis. Assessment has performed by radiographic exam.~   "
12716|NCT02890784|"~     Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve~     disease (1st line) and patients with resistance or intolerance against alternative~     Abl-Kinase Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved~     Tolerability))~   "
12717|NCT02890771|"~     Periodontal disease is considered as inflammatory, multifactorial, and threshold disease~     accompanied by destruction of periodontium and eventually the loss of natural teeth.~     Periodontal disease is highly prevalent dental disease especially, in developing and~     underdeveloped countries affecting more or less 80% of the population. For the prevention of~     this highly prevalent dental affliction, still no effective and practical preventive~     measures are available which can reduce its high prevalence rate though, lot of research~     work is going on.~   "
12718|NCT02890758|"~     The purpose of this study is to find the number of natural killer (NK) cells from non-HLA~     matched donors that can be safely infused into patients with cancer. NK cells are a form of~     lymphocytes that defend against cancer cells. NK cells in cancer patients do not work well~     to fight cancer. In this study, the NK cells are being donated by healthy individuals~     without cancer who are not matched by human leukocyte antigen (HLA) genes to patients.~     After receiving these NK cells, patients may also be given a drug called ALT803. ALT803 is a~     protein that keeps NK cells alive, helps them grow in number and supports their~     cancer-fighting characteristics. HLA-unmatched NK cell infusion is investigational~     (experimental) because the process has not approved by the Food and Drug Administration~     (FDA).~   "
12719|NCT02890745|"~     The purpose of this study is to investigate the effect of empagliflozin on oxidative stress~     in patients with type 2 diabetes. The association is examined by comparing the difference in~     oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared~     to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each~     treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are~     measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and~     8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment~     with placebo. The results will be published in a peer-review journal.~   "
12720|NCT02890732|"~     This project will benefit from the results of the concept study conducted from July to~     October 2014 from groups of coronary patients. This first study will help to develop the~     precise contours of Appet HEART application for the production of the prototype version used~     in the clinical feasibility study.~      The objectives of the feasibility study are:~        1. assess the rate of use of the application~        2. to determine the ideal target population of the application~        3. to evaluate the effectiveness of the application~        4. to measure the risks and potential limitations of its use~        5. to determine the medical and economic impact of this application~   "
12721|NCT02890719|"~     Pilot, single center, open-label study to evaluate the efficacy and tolerability of~     Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant~     recipients with hepatitis C recurrence.~   "
12722|NCT02890706|"~     Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for~     patients with suspected with pulmonary embolism.~   "
12723|NCT02890693|"~     MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional~     interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic~     and mental health of women with GDM and their offspring.~      Primary objective of MySweetHeart Trial:~      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial~     intervention in women with GDM to improve 1) their metabolic health (decrease in maternal~     weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their~     mental health (decrease in maternal symptoms of depression during the same time period).~      Secondary objective of MySweetHeart Trial:~      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial~     intervention to improve other cardio-metabolic and mental health markers in women with GDM~     and their offspring.~      MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that~     assesses the effect of GDM on offspring cardiovascular health early in life. The principal~     investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital~     Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the~     surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and~     subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on~     the cardiovascular structure and function during the fetal period and neonatal adverse~     cardiovascular risk factors.~   "
12724|NCT02890680|"~     The purpose of this study is to evaluate the bone regeneration after impacted third molar~     surgery on split mouth design using platelet-rich fibrin.~   "
12725|NCT02890667|"~     This study is a population based observational study conducted on the French administrative~     databases to estimate cancer incidence in 2012 by using the ECHANTILLON GENERALISTE DES~     BENEFICIAIRES (EGB, a 1/97th dynamic random sample of the SNIIRAM).~      The EGB database contains anonymous and prospectively recorded data about all beneficiaries'~     medical reimbursements. Many algorithm definitions are defined to estimate the incident rate~     of cancer in 2012 from the EGB database. The incidence rates obtained by each algorithm~     definition are compared to national incidence rates by indirect age and sex standardization.~     National incidence rates are obtained from FRANCE CANCER INCIDENCE ET MORTALITE (FRANCIM):~     the French network of cancer registries.~   "
12726|NCT02890654|"~     Around the scoliosis surgery, the pain (pre or post operative, physical, psychological,~     fantasy or real) is a major concern for adolescents and their families. She is also a key~     concern of caregivers, both its assessment and management is complex. this pain involved~     predominantly in the quality of life of these teenagers today who will become the adults of~     tomorrow.~      To date in France, no study aims to describe and evaluate the effect of a multidisciplinary~     approach and its impact on the quality of life of these young people made.~      The present study wish to prevent, anticipate and limit the short, medium and long-term~     morbidity. Focus will be on pain and its management, on preparing for surgery,~     hospitalization, follow-up after surgery, rehabilitation until recovery.~      Help teens reclaim their bodies after the changes caused by the intervention is a major~     issue.~      This study believe that support good quality, adapted to patient needs will limit operating~     and postoperative pain in the medium and long term.~      Medical team developed special attention around the teenagers that are operated for~     scoliosis (teen groups and parent groups, interview before the operation and counseling,~     physiotherapy support ...).~      The present study would systematize data collections in order to have a comprehensive and~     accurate assessment of the care.~      The qualitative research will focus on the multidisciplinary care in an effort to evaluate~     the whole course of these teenagers, their experience and to identify efforts to put in~     place to optimize the current care.~   "
12727|NCT02890641|"~     Genetic abnormalities in focal epilepsies are well known. A novel gene (DEPDC5) was~     identified, associated with various genotypes of epilepsies. Recently, DEPDC5 mutations were~     identified also inside focal cortical dysplasias. This could suggest that a somatic mutation~     in DEPDC5 could be responsible for the cortical dysplasia. The study aims to identify~     various genetic mutations responsible for drug-resistant focal epilepsies due to Focal~     cortical dysplasia in children undergoing surgery for epilepsies due to focal cortical~     dysplasias in Rothschild Foundation, Paris. Patients and their parents will be recruited to~     identify genetic abnormalities both in lymphocytic and cortical DNA.~   "
12728|NCT02890628|"~     This study is to explore perceptions, experiences, beliefs and knowledge around teenage~     pregnancy, motherhood, sexual and reproductive health, family planning and support~     structures adolescent refugees and migrants and to identify demographic, social and medical~     characteristics of study participants.~   "
12729|NCT02890615|"~     Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1~     year after diagnosis, experience depressive symptoms that can have a negative impact on~     their quality of life. Canadian care guidelines for cancer survivors recommend supporting~     the active engagement of survivors in their self-care.~      This study is an evaluation of the effect of a depression self-care program which includes a~     self-care toolkit and support in the form of regular telephone calls from a self-care coach.~      The toolkit contains tools that help cancer survivors:~        1. Learn new information to better understand depression. This can help people feel that~          they are not alone, and that their experience is not abnormal. Better understanding a~          condition also helps people feel more confident in their communications with health~          care professionals and can make it easier to share their experience with family and~          friends.~        2. Learn and practice new coping skills. This can help people feel confident that they can~          engage in the behaviours that have been shown to be beneficial for mood, e.g.~          restructuring thoughts, problem solving, and planning pleasant activities.~      People eligible for the study are aged 18 and over, 1-10 years post-diagnosis, have~     completed primary cancer treatment (chemotherapy, radiation therapy or surgery) for any type~     of cancer, and have moderate depressive symptoms (as measured by a Patient Health~     Questionnaire (PHQ-9) score of 8-19). Recruitment will be conducted at cancer care centres~     in Montreal and at the Princess Margaret Cancer Centre in Toronto, and via community cancer~     support groups in Quebec and Ontario. Each participant enrolled in the study will receive~     the self-care toolkit (half will receive the toolkit and support calls at the start of the~     study, and half will receive the toolkit at the end), and will be followed for 6 months.~      This proposed self-care program is innovative in its approach to the treatment of depression~     and has the potential to significantly improve the quality of life for Canadian cancer~     survivors with persistent depressive symptoms. The results of the study will determine~     whether the supported depression self-care program for cancer survivors is effective. The~     program is designed to be sustainable and widely applicable as it involves minimal costs,~     and the coaching can be delivered by telephone by volunteers in hospital and community~     settings. Investigators will work with clinical stakeholders and patient representatives to~     ensure that deliverables are relevant to the target population. Specific deliverables (in~     both French and English) include: a toolkit with a manual describing its use; a manual~     detailing coaching procedures; reports for decision makers and community cancer care groups;~     and short summaries for stakeholder groups.~   "
12730|NCT02890602|"~     This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in~     patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate~     hematopoietic response of darbepoietin alfa and the quality of life assessment of~     increasement of hemoglobin.~   "
12732|NCT02890576|"~     The number of patients with cochlear implants increases every year, constituting an active~     queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380~     adult patients). The number of approved cochlear implant centers is limited by~     guardianships, and corresponds to the Hospitals University. It is not possible to create~     networks of correspondents. Teams of implantation centers must meet the needs of new~     patients and ensure continuity of care for patients already implanted: speech therapy~     monitoring, adjustment and rehabilitation.~      In case of malfunction of the implant, patients use in first-line reference center. The~     increasing number of patients leads to a lack of specialized teams that can not meet the~     demands of patients in a timely manner, while continuing to provide support for new~     patients. It is therefore necessary to find solutions to improve the service provided to~     patients who received a cochlear implant system to respond quickly and effectively to the~     request of troubled patients, while optimizing the workload of the teams . The introduction~     of a telemedicine platform is expected to achieve these goals, distinguishing minor~     malfunctions, not requiring a consultation in a center, and the most complex situations~     requiring consultation in a center.~   "
12733|NCT02890563|"~     Study purpose is to research whether compression therapy is beneficial after truncal vein~     RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be~     randomised to either no compression group (Group I) or compression group (Group II)~   "
12734|NCT02890550|"~     The aim of the study is to characterize the clinical manifestations of ALMS within the~     ciliopathies to prevent complications and determine preventive and therapeutic targets.~      The investigators believe that the clinical consequences of mutations in the gene result~     ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about~     the understanding and decision support other ciliopathies, but also about some common~     diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated~     a model of the channel concerned. Secondarily, the clinical data generated by this project~     will also be used as part of basic research (eg comparison with results in animal models,~     use of human cells for in vitro studies or transcriptomic ....) (which will be a secondary~     upgrading to this work).~   "
12735|NCT02890537|"~     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of~     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.~     Core decompression is currently the treatment of choice for early stage osteonecrosis of the~     femoral head. This method consists in decompressing the rigid intra-osseous chamber to~     promote revascularization, thus halting progression of the disease and stimulating repair.~     Still this treatment remains highly controversial, since the success rates of the first~     studies have not been repeated.~      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.~     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,~     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells~     recruitment.~      Three studies have indicated the potential clinical benefits of cell-based approaches for~     the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al.~     2004). This is on the basis of these observations that a proprietary population of~     autologous osteoblastic cells (PREOB®) has been developed.~      This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment~     of early stage osteonecrosis of the femoral head. The primary goal of this study was to~     investigate the safety and efficacy of the implantation of the investigational product~     PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone~     marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head,~     with a follow-up period of up to 5 years.~   "
12736|NCT02890524|"~     The investigators will investigate whether the night guard can suppress the development of~     recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral~     condition for 60 days before and after intervention with the night guard made of~     Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for~     measurement of inflammatory cytokines or oxidative stress.~   "
12737|NCT02890511|"~     A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose~     and recommended dose for phase II trial in patients with advanced solid cancer and explore~     efficacy of DHP107 in patients with gastric cancer~   "
12738|NCT02890498|"~     Retrospective analysis of vaginal microbiota in the post-operative course of patient~     operated for genital prolapse with vaginal mesh with or without mesh related complication~   "
12739|NCT02890485|"~     This study is testing the effectiveness of dry needling for pain management and on muscle~     strength and leg function for those with knee pain. Dry needling consists of small,~     monofilament needles that are administered directly into the tissue and manipulated to make~     the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal~     muscle and connective tissue to help diminish pain, reduce impairments of body structure and~     restore function.~   "
12740|NCT02890472|"~     22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch~     between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult~     series despite a perinatal mortality of 16% suggesting opportunities for improvement in the~     prenatal diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease~   "
12741|NCT02890459|"~     The success of combination HIV prevention efforts, including HIV treatment as prevention,~     hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The~     proposed study will evaluate the comparative effectiveness and sustainability of innovative~     incentive strategies, informed directly by behavioral economics and decision psychology, to~     promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.~   "
12742|NCT02890446|"~     This study compares the effects of an internal versus an external focus of attention on~     motor training of the affected arm for individuals with stroke. Participants were randomly~     assigned to either the internal or external focus treatment groups and received 12 sessions~     of arm training.~   "
12743|NCT02890433|"~     The national recommendations promote the applying of the Contact Additional Precautions~     (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant~     (MDR) bacteria. However, that could entail more costs and a reduction of quality of the~     patient care.~   "
12745|NCT02890407|"~     The association study will compare the allele frequencies of polymorphisms of a single~     nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control~     population.~      Patients will be included only if they are suffering from a typical form of tight and~     surgical tricuspid aortic stenosis. Patients will therefore only included if they are~     suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis~     or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.~   "
12746|NCT02890394|"~     The project is based on checking the effectiveness of the technique of suboccipital~     inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves~     the placement of the hands of the physiotherapist under the patient's head so that fingers~     can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads~     upward to contact the occipital condyles. At this point the investigator should gently move~     your fingers down, finding the space between the condyles and the spinous process of the~     axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull.~     In this technique the investigator would be carrying out the relaxation of the suboccipital~     muscles: lower rectus capitis posterior, superior oblique head straight back and head~     higher. It is a technique used very often but without knowledge about the time needed for~     implementation. In several studies that have used the technique it has been maintained for~     2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three~     groups formed by patients with mechanical neck pain that they applied the technique two,~     four or ten minutes and a control group of patients with mechanical neck pain. The four~     groups were measured before and after treatment the pain threshold to pressure by algometer~     and conduct the test repositioning of the head to show any changes after application of the~     technique.~   "
12747|NCT02890381|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to CIR 312.~   "
12748|NCT02890368|"~     This is a multicenter, open-label, phase 1 study that is being done to test intratumoral~     injections of TTI-621 in subjects that have relapsed and refractory percutaneously~     accessible solid tumors or mycosis fungoides.~      The study will be performed in two different parts. Part 1 is the Dose Escalation phase and~     Part 2 is the Dose Expansion phase.~      The purpose of this study is to characterize the safety profile of TTI-621 and to determine~     the optimal dose and delivery schedule of TTI-621.~   "
12749|NCT02890355|"~     This randomized phase II trial studies how well modified irinotecan hydrochloride,~     leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work~     compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a~     period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan~     hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and~     veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic~     pancreatic cancer.~   "
12750|NCT02890342|"~     Background:~      People s bodies need to break down food into the chemicals. These chemicals are used for~     energy and growth. Some people cannot process all chemicals very well. Too much of some~     chemicals can cause diseases. One of these diseases is called propionic acidemia (PA).~     People with PA can have problems with growth, learning heart, abdomen, and other organs.~     Researchers want to better understand how these problems happen.~      Objective:~      To learn more about propionic acidemia and the genes that might contribute to it.~      Eligibility:~      People at least 2 years old with PA who can travel to the clinic~      Some unaffected family members~      Design:~      Participants will have a 3 to 5-day hospital visit every year or every few years. Family~     members may have just 1 visit.~      During the family member visit, they may have:~      Medical history~      Physical exam~      Samples of blood and urine~      Questions about diet and a food diary~      Doctors and nurses may do additional studies:~      Samples of saliva, skin and stool~      Fluid from a gastronomy tube, if participants have one~      Dental and eye evaluations~      A kidney test - a small amount of dye will be injected and blood will be collected.~      Consultations with specialists~      A test of calories needed at rest. A clear plastic tent is placed over the participant to~     measure breathing.~      Stable isotope study. Participants will take a nonradioactive substance then blow into a~     bag.~      Photos taken of the face and body with underwear on~      Ultrasound of the abdomen~      Heart tests~      Hand x-ray~      Brain scan~      Participants may have other tests if study doctors recommend them. They will get the results~     of standard medical tests and genetic tests.~   "
12751|NCT02890329|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia~     that has returned after a period of improvement or does not respond to treatment. Monoclonal~     antibodies, such as ipilimumab, may block cancer growth in different ways by targeting~     certain cells. Drugs used in chemotherapy, such as decitabine, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work~     better in treating patients with relapsed or refractory myelodysplastic syndrome or acute~     myeloid leukemia.~   "
12752|NCT02890316|"~     To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive~     and emotional functions.~   "
12753|NCT02890303|"~     This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies~     during cataract surgery with phacoemulsification.~   "
12754|NCT02890290|"~     The purpose of this study is to determine whether a marine protein hydrolysate given as a~     supplement to meals with low protein content can prevent age related loss of muscle mass and~     improve physical function in frail elderly. The study will recruit elderly living at home~     with help from municipal health care services, and a secondary goal of the study is to~     describe food habits, seafood intake and nutritional status in this group of patients.~   "
14521|NCT02867202|"~     This study was taken out to compare two mechanical devices (intrauterine balloon and~     intrauterine contraceptive device) in the therapy for intrauterine adhesions after~     hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.~   "
12755|NCT02890277|"~     Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic~     diseases shown as female genital skin and mucosal tissue degeneration and pigmentation~     change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal~     skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug~     or surgical treatments. However, the effect is not good enough, but the diseases often recur~     and severely affect patients' quality of life. In this study, the investigators combined the~     technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang~     Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug~     to treat. The data from colposcopy and biopsy pathology were collected before and after~     treatment to create the objective identifying degree of the disease by with grading~     methods and evaluate the treatment effect. At the meantime, the standardized treatment~     procedure, methods and efficacy criterion were all stipulated to achieve satisfactory~     results, which could be used to clinical treatments. So far, the investigators have not seen~     similar study reported internationally.~   "
12756|NCT02890264|"~     The main purpose for holding this survey is epidemiological surveillance, it must provide~     the indicators that contribute to the evaluation of the plan improvement of the quality of~     life in chronic diseases and monitoring the goal of 81 health law public in August 2004.~     This survey is intended to be renewed during the implementation period of the public health~     law to provide plan monitoring indicators.~      The main objective is : To describe the quality of life of patients with major end-stage~     renal disease treated with dialysis method for at least one year.~      The seconds objectives are :~        -  To contribute to the knowledge of the key determinants of the quality of life among~          chronic renal failure patients.~        -  To study the influence on way of giving a questionnaire about assessment of level of~          quality of life~   "
12757|NCT02890251|"~     The purpose is to describe the level of visual maturation of premature newborns at term~     equivalent age.~      The secondary purpose is to determine factors associated to an altered level of visual~     maturation, through an exploratory approach.~   "
12758|NCT02890238|"~     100 women with infertility classified into 2 groups.~      Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2~     times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day~     of the same cycle orally 3 times/day.~      Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2~     times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same~     cycle orally 3 times/day.~   "
12759|NCT02890225|"~     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to~     eliminate stone completely,previous studies have proved that the application of External~     Physical Vibration Lithecbole(EPVL) treatment can effectively promote the discharge of renal~     residual stones after RIRS, improve the stone free rate(SFR) .However, when is the the best~     time of performing EPVL , and with the least complication, there is still no~     conclusion.Therefore, researchers purpose to evaluate the effectiveness of EPVL in treatment~     of residual fragments in different time (3 days ,7 days and 14 days) after RIRS by~     prospective study of clinical trial, which will determine the best time for performing EPVL~     treatment.~   "
12760|NCT02890212|"~     The main goals of antidepressant treatments are to achieve remission of depressive episodes~     and prevent recurrences. However, clinical trials designed to approve antidepressants~     targets a response rate of at least 50%, which is considered partially effective. Therefore,~     there is a need for new treatment strategies, including augmentation with other substances~     such as lithium. This research aims to verify through a pilot study, the effect of selenium~     as an augmentation treatment for sertraline-resistant major depression. This clinical trial~     was designed to be a randomized, placebo-controlled, double-blind trial evaluating the~     effect of selenium or placebo in subjects diagnosed with major depression who have not~     responded to treatment with sertraline~   "
12761|NCT02890199|"~     During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into~     the vaginal tissues to help with tissue dissection. It is common that anesthetic medication~     is mixed into this fluid to help with pain control after surgery. Usually the pain~     medication injected is short-acting. In this study the investigators plan to compare the~     usual short-acting injected pain medication with a long-acting injected pain medication to~     evaluate whether this improves pain control after surgery.~      One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous~     ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study~     participants will be randomized to one of two study groups:~        1. Lidocaine group (short-acting medication).~        2. Liposomal bupivacaine group (long-acting medication)~      Information will be collected on study participants, including: demographics, procedure~     data, and post-operative information. The primary outcome of this study is determine if use~     of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads~     to less post-operative pain compared to short-acting local anesthesia.~      Secondary outcomes include:~        1. post-operative opioid medication use~        2. return to baseline pain status~        3. post-operative time to first bowel movement~        4. post-operative antiemetic use (nausea medication)~        5. results of voiding trial after surgery~        6. patient satisfaction with pain control~   "
12762|NCT02890186|"~     To investigate the application of closed target-controlled infusion(TCI) of propofol and~     remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion~     with internal fixation surgery.~   "
12763|NCT02890173|"~     To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients~     with essential hypertension.~   "
12764|NCT02890160|"~     The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting~     Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device~     has been preliminary confirmed in a small-scale First-in-Man clinical trial.~   "
12765|NCT02890147|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to perform a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort~     to compare with systemic autoimmune diseases cohort into molecular clusters instead of~     clinical entities through the determination of molecular profiles using several Omics~     techniques.~   "
12766|NCT02890134|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to performe a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research consiteis to reclassify the individuals~     affected by SADs into molecular clusters instead of clinical entities through the~     determination of molecular profiles using several Omics techniques.~   "
12767|NCT02890121|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to perform a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research is to reclassify the individuals affected by~     SADs into molecular clusters instead of clinical entities through the determination of~     molecular profiles using several Omics techniques.~   "
12768|NCT02890108|"~     This study will compare the effect of acute consumption of two carbonated drinks, sweetened~     with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who~     normally consumed foods or drinks that contain non-caloric sweeteners~   "
12769|NCT02890095|"~     Exposure to certain classes of chemical contaminants, including certain persistent organic~     pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that~     lead to increase incidence of breast cancer in the Western world .~      However, the causal role of POPs in the onset of breast cancer remains nowadays unproven.~     Preliminary epidemiological studies on the impact of these environmental factors in breast~     cancer etiology have ignored the critical periods of exposure. Similarly, they have~     considered a limited number of pollutants (not including possible joint or synergistic~     effects between individual compounds) and did not distinguish the different breast cancer~     subtypes may have different etiologies or even of genetic susceptibility factors (POP~     polymorphism of detoxification enzymes).~      Thus, POPCASE study examines the association between the presence of breast cancer and the~     levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood,~     in particular using spectrometric methods developed by the team LABERCA (Nantes, France).~     These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame~     retardants) will be measured both quantitatively (tissue concentrations) and qualitative~     (relative proportions of different pollutants sought).~   "
12770|NCT02890082|"~     The rates of patients with spontaneous pregnancies reported after breast cancer is between 3~     and 7%, particularly because of these treatments.~      Therefore, it is essential to anticipate this problem by proposing the use of fertility~     preservation techniques for these young patients prior to any gonadotoxic treatment.~      PRESAGE study offers to patients fewer than 40, to preserve their fertility before~     neoadjuvant or adjuvant chemotherapy for invasive breast cancer.~      The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order~     not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen~     followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or~     embryonic.~      This procedure is already done in many countries, and by some French teams, by combining~     tamoxifen or letrozole to the classic gonadotropin stimulation.~   "
12771|NCT02890069|"~     The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents~     with immunomodulatory activity to identify the doses and schedule for combination therapy~     and to preliminarily assess the safety, tolerability, pharmacological and clinical activity~     of these combinations.~   "
12772|NCT02890056|"~     The purpose of this study is to determine the efficacy of a community-based behavioral~     intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water~     consumption among school-aged youth and parents/caregivers. We hypothesize that participants~     in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and~     increased water intake compared to participants in the comparison site at 2 and 6 months~     follow-up.~   "
12773|NCT02890043|"~     The object of this study was to evaluate the accuracy and safety of the Tirobot system.~   "
12774|NCT02890030|"~     The patients enrolled on this new study will serve as an appropriate comparison group~     consisting of patients with the diagnosis of germ cell testicular cancer who were cured with~     surgical resection and did not receive cisplatin-based chemotherapy with a group of patients~     from another study who did receive cisplatin-based chemotherapy.~   "
12775|NCT02890017|"~     This is a medico-economic study of outpatient surgery paired with a night stay in a~     patient-hotel, compared with a conventional hospitalization for three types of urological~     surgeries.~      The aim is to show that those two strategies are not different in term of adverse effects or~     rehospitalization, and that the patient-hotel provide a better quality of life at a reduced~     cost, in order to generate savings for the paying agent: the Healthcare insurance.~   "
12776|NCT02890004|"~     This prospective, observational study aim to identify :~        -  Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care~          unit~        -  The impact of standard therapeutic used (surgery, embolization ; medical treatment of~          vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)~   "
12777|NCT02889991|"~     This study evaluates the deep dry needling technique as a percutaneous technique included in~     the professional field of physiotherapy.~      The project quantifies a significant limit on the number of local twitch responses necessary~     for the favorable treatment of myofascial pain and analyzes the injury degree and/or the~     repair of myofascial tissue, with Elastography.~   "
12778|NCT02889978|"~     GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop~     assays to detect cancer early in blood. The purpose of this study is to collect biological~     samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors~     who do not have a diagnosis of cancer (blood) in order to characterize the population~     heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing~     cancer from non-cancer.~   "
13021|NCT02886806|"~     Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management~     based on a combination of several physiological variables (bispectral index [BIS], stroke~     volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop~     systems (PCLS) in patients undergoing high risk vascular surgery~   "
12779|NCT02889965|"~     OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in~     France. It aims to provide a major epidemiological tool on MS for the scientific community~     in France and abroad. This tool must help to answer a large number of questions concerning~     the causes and mechanisms of MS, the prognostic factors of disease progression, the~     effectiveness and safety of therapeutic drugs, the impact of the disease on patients and~     society, etc.~      In December 2015, it has already included more than 54.000 patients. To achieve this goal,~     OFSEP's objectives are~        -  To maintain and develop the French cohort of patients suffering from MS or related~          diseases and syndromes. This means collecting standardized socio-demographic and~          clinical data as part of the routine medical follow-up of patients already in the~          cohort and recruitment of new patients.~        -  To supplement the existing clinical data with standardized and quality biological~          samples and MRI scans.~        -  To improve the previous data with medical/administrative data from the health insurance~          fund databases in particular, in order to get more information on comorbidity,~          treatment protocols and the medico-economic aspects of this disease.~        -  To use OFSEP infrastructures to facilitate the implementation of specific studies~          requiring the collection of additional data or specific patient monitoring processes.~        -  To ensure the availability of these data and samples to researchers, health care~          authorities and industrial players to enable analysis and thus provide answers to~          research questions or public health issues. This availability is only possible after~          scientific and regulatory evaluation of the request.~        -  To provide regular descriptions of the patient population in the cohort to offer~          statistics, targets and up-to-date information on this disease and thus enable a better~          approach to the personal, professional and social impacts of the illness, the effects~          of basic treatments and the requirements related to the follow-up of this disease in~          France.~        -  To conduct specific studies on the entire population of patients in the cohort (parent~          cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four~          nested cohorts have been defined: patients with radiologically isolated syndromes,~          patients with clinically isolated syndromes, patients with primary progressive courses~          of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum~          disorders.~   "
12780|NCT02889952|"~     This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid~     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy~     (TT).~      It compares two groups of consecutive patients who underwent TT associated or not to lymph~     node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.~   "
12781|NCT02889939|"~     The aim of this project is to investigate whether it is possible to improve the functioning~     and activity level for individuals more than 6 months after stroke by partaking in a~     rehabilitation program consisting of high-intensity task-specific, goal-directed training in~     an enriched environment.~   "
12782|NCT02889926|"~     Leg ulcers are defined as wounds lasting for more than a month. They would receive 0.2% of~     the population of Western countries. In Europe, the cost per episode of leg ulcers is~     estimated at 6650 euros (10 000 euros for a foot ulcer). The cost of treatment of wounds~     would be 2 to 4% of the health budget. Infection is the most common complication of chronic~     wounds: in most cases, it results in delayed healing, at most, it can result in amputation~     or serious general complications Bacterial contamination of ulcers is constant. Over time~     for over 25 years, various studies have shown about relatively identical results. The~     bacteria are present in over 90% of the etiology of venous leg ulcers. These bacteria are~     divided into four most common classes: Staphylococcus aureus, Enterococcus, Streptococcus,~     Pseudomonas. The bacterial ecology changes over time. Indeed Staphylococcus aureus appears~     first, while the Pseudomonas is associated with ulcers lasting for several months. Anaerobic~     more difficult to find, are found in 30% of cases Cohabitation between leg ulcers and~     bacteria often without clinical consequence: These are the stages of infection and~     colonization.~      The infection is related to the proliferation of bacteria and their invasion into the skin,~     by increasing their virulence (virulence genes acquisition). The increase in the number of~     bacteria and the multiplicity of bacterial genera are one reason for the increased virulence~     of bacteria. When bacteria proliferate, because the host defenses are inadequate, or because~     there is a vascular disease which promotes the proliferation, clinical signs appear~   "
12783|NCT02889913|"~     Leg ulcers are frequent. There are no epidemiological studies available in France, but~     international studies estimate the prevalence between 0.045 and 0.63% of the total~     population, prevalence increases with age, reaching 5% of patients over 80 years.~     Extrapolating these prevalences in the French population between 28 000 and 395 000 people~     are affected in France a leg ulcer.~      It is a costly disease. In 2001, a French study conducted among 800 physicians, including~     85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was~     estimated that the total cost of treatment per patient average was 888 32 euros. This is~     truly a public health problem.~      Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed).~     However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis.~     These ulcers rare causes require specific treatments that can often heal. To diagnose, to~     perform a skin biopsy. Thus, the general practitioner must know when to put the indication~     for biopsy of a leg ulcer.~   "
12784|NCT02889900|"~     This is an open label, single arm, multi-center study to assess the efficacy and safety of~     the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade~     serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal~     carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not~     carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)~     mutations.~   "
12785|NCT02889887|"~     The aim of this study is to analyse correlation between the sensory processing and motor~     development in preterm infants.~   "
12786|NCT02889874|"~     This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus~     observation following breast conserving surgery and planned endocrine therapy in patients~     with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.~   "
12787|NCT02889861|"~     IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100~     for eligible patients with advanced melanoma who have previously participated in an IMCgp100~     study (parent study).~   "
12788|NCT02889848|"~     This pilot study evaluates the safety and tolerability of a single injection of collagenase~     enzyme directly into a uterine fibroid in subjects already selected for hysterectomy.~      Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen~     may be beneficial in reducing pain and bleeding associated with fibroids.~      Three subjects will be injected with saline only to evaluate the safety and effectiveness of~     the injection method. Additional subjects will then be injected with increasing doses of~     study drug.~   "
12789|NCT02889835|"~     This study will examine the clinical performance of Class II restorations over a three year~     period with 3 composite resins - a conventional composite resin, a flowable composite resin~     and a bulk placed and cured composite resin.~   "
13048|NCT02886455|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive.~   "
12791|NCT02889809|"~     There is a regulatory requirement to evaluate the extent of reduction (if any) of growth~     velocity associated with inhaled corticosteroid (ICS) containing products that are to be~     administered to children, and to this end there is Food and Drug Administration (FDA)~     regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind~     (treatment period), parallel group, placebo controlled, multicentre study to assess the~     effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth~     velocity in prepubertal asthmatic children on a background therapy of open-label~     montelukast. This study will be conducted over a total duration of approximately 76 weeks:~     16-week run-in period (single-blind placebo inhaler), 52-week double-blind treatment period~     (inhaled FF 50 mcg /placebo administered OD in the morning for 52 weeks) and 8-week~     follow-up period. The purpose of the study is to evaluate the magnitude of effect (with a~     level of precision) on growth velocity of prepubertal asthmatic paediatric subjects (aged 5~     to <9 years) following administration of OD inhaled FF 50 mcg for one year. This study~     fulfills European Union (EU) and United States (US) regulatory requirements for the~     evaluation of potential growth suppression in children.~   "
12792|NCT02889796|"~     The primary objective of this study is to evaluate the effects of filgotinib versus placebo~     in adults with active rheumatoid arthritis (RA) who have an inadequate response to~     methotrexate (MTX).~   "
12793|NCT02889783|"~     This is a routine evaluation of urethral sensation during urodynamic studies. The record has~     been realized retrospectively. The investigators propose a new way to represent urethral~     sensation, in a simple and non-invasive way.~   "
12794|NCT02889770|"~     This studies´ objective is to describe how different PEEP levels affect dead space measured~     by Bohr´s formula.~   "
12795|NCT02889757|"~     Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by~     supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However,~     there are few published data and large sample sizes regarding the protective effect of NAC~     against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.~      Therefore, the investigators designed a clinical trial with the aim to see whether NAC could~     protect against anti-TB drug-induced hepatotoxicity (DIH)~   "
12796|NCT02889744|"~     The investigators hypothesize that~        1. if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the~          33-TH may be lower than that in the 36-TH group.~        2. if decrease in SctO2 level is not caused by the degree of hypothermia but caused by~          brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest~          victims regardless of core temperatures.~      The primary objective of this study is to compare the 72-hour changes in SctO2 level between~     the 36-TH and 33-TH groups in cardiac arrest victims.~   "
12797|NCT02889731|"~     Background: Suicides by jumping from the high buildings of acute hospitals are dramatic~     events which are highly traumatizing to families, staff and fellow pts. In the 10 years~     from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures~     taken to predict and avoid them.~      The investigators hypothesized that constructive measures at the windows that would render~     access more difficult could discourage spontaneous suicidal behaviour and would reduce the~     suicide rates.~      Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg)~     was installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above~     the window parapet with the aim to visually, psychologically and physically discourage~     potential suicidal impulses.~   "
12798|NCT02889718|"~     This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on~     the effect of the hypnotic agent, measured by the bispectral index of the~     electroencephalogram, to maintain the hypnosis level within the recommended limits for~     general anesthesia. The analgesic agent is administered in Target-Controlled Infusion =~     TCI and analgesia evaluated by pupillometry.~      This is a prospective, open, non-controlled, non-randomized, monocentric study. The main~     objective is to study the potential contribution of the system in the conduct of~     anaesthesia, as decision support, for the administration of the hypnotic agent.~      Secondary objectives will include hemodynamic stability, and the average concentrations of~     opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.~      The study will involve surgical patients scheduled for surgery under general anesthesia for~     more than 1 (one) hour.~   "
12799|NCT02889705|"~     Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular~     torticollis (CMT) infants with quantified echotexture and measured thickness during the~     treatment course.~      Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital.~     Participants: Infants with clinical diagnosis of CMT, without any neurological presentation,~     cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the~     study.~      Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least~     two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM~     muscles during the follow-up period.~      End of follow-up: Subjects who still had prominent clinical presentations after~     physiotherapy for 6 months or were older than 1 year would receive surgery. Subsided~     presenting clinical features determined by the clinician was the other end-point of this~     investigation.~      Main Outcome Measures: The K value, derived from the difference of echo intensities (2)~     between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to~     represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and~     involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal~     sonograms. Clinical outcome was also recorded.~   "
12800|NCT02889692|"~     The investigators performed a randomized, double blind controlled, prospective study method~     on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy~     maintenance to prolong the efficacy of long-term survival of advanced pulmonary~     adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3~     years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy~     maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance~     therapy has a better efficacy on prolonging progression-free survival time, overall~     survival, improving quality of life(QOL) of patients than that of targeted maintenance~     therapy.~   "
12801|NCT02889679|"~     The aim of this study is to compare the efficacy of underwater resection (polypectomy)~     versus conventional polypectomy techniques for small and large colorectal lesions identified~     during colonoscopy.~   "
12804|NCT02889640|"~     This research aims to examine the extent to which a promising academic~     intervention—high-intensity tutoring by SAGA Innovations—that has previously been shown to~     significantly improve academic outcomes for disadvantaged Chicago youth can be implemented~     at an even greater scale. By taking advantage of the power of random sampling, this study~     will allow for observation of the program's effectiveness as if it were running at five~     times the proposed scale. In addition, this study will explicitly explore the extent to~     which there is a trade-off between effectiveness and scale.~   "
12805|NCT02889627|"~     Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This~     clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation~     for epilepsy.~   "
12806|NCT02889614|"~     Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic~     of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic~     (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims~     to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related~     psychiatric disorders.~   "
12807|NCT02889601|"~     Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of~     patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore~     developed a quantification and follow-up scale specifically dedicated to patients with FTD~     in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy,~     Perseveration, Hyper orality, Negligence and loss of Empathy.~   "
12808|NCT02889588|"~     Refractive surgery includes interventions to correct refractive errors, using a medical~     device such as a laser or an implant (intraocular lenses) or surgical instruments. The study~     distinguishes corneal interventions, carried on the surface of the eye, and intraocular~     interventions, performed on the lens or in the anterior or posterior chamber of the eye. The~     number of procedures in refractive surgery is growing significantly. They seem to offer~     satisfactory visual results but a number of issues remains unresolved. In order to get~     emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower~     orders (ie spherical refractive error and astigmatism). This increases high-order~     aberrations (the most common is a bright halo on the edge of the image). The cutting of the~     flap to the surface of the cornea in the case of LASIK increases high-order aberrations,~     which have the effect of reducing post-surgical visual performance (ie visual acuity and~     contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact~     lenses on a post-operative cornea is more complex. It is therefore necessary to limit these~     post-surgical aberrations and to identify their possible sources. Indeed, some authors have~     provided insight into the effects of some high-order aberrations, but the influence of~     several factors characterizing the preoperative eye on refractive surgery are still unknown,~     such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or~     astigmatism.~   "
12809|NCT02889575|"~     Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular~     filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF~     involving distress and destruction of tubular cells. This specific typology of ARF may~     evolve toward Chronic Renal Failure (CRF) concretizing a major public health issue.~      Predict the progression of ARF towards CRF appears essential. The investigators believe that~     the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk~     towards CRF.~   "
12810|NCT02889562|"~     In this open-label, prospective, randomized pilot study, patients who develop atrial~     fibrillation after isolated coronary artery bypass grafting surgery will be identified.~     Patients with persistent atrial fibrillation (>12 hours) or recurrent sustained atrial~     fibrillation (>2 episodes of atrial fibrillation lasting longer than 30 minutes) will be~     candidates for inclusion. Upon meeting study inclusion and exclusion criteria, and after~     informed consent, patients will be randomized to either the standard of care (warfarin per~     protocol) or apixaban arms of the trial. Routine postoperative care after CABG will occur in~     both groups. Upon discharge, anticoagulation in both groups will be managed by the~     anticoagulation clinic. Patients will be followed for 30 days after surgery.~   "
12811|NCT02889549|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been~     formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg~     daily plus aspirin for ACS patients. However, few East Asian patients have been included in~     these trials to assess the use of these drugs. In addition, a growing body of data supported~     that East Asian might have different adverse event profiles (thrombophilia and bleeding) and~     therapeutic window compared with white subjects. But it is still not clear whether a low~     dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary~     disease.~      Recent studies found that antiplatelet drugs might have anti-inflammatory effects and~     protect endothelial function. ACS patients treated by ticagrelor had a significantly higher~     increase in levels of circulating progenitor cells compared to those treated by clopidogrel,~     suggesting a benefit on endothelial regeneration that may participate in the pleiotropic~     property of the drug. This may prompt the regression of blood vessels and the endothelium~     stability. But it is not very clear that the effect of low-dose ticagrelor on vascular~     endothelial function in diabetic patients with stable coronary artery disease.~      Therefore, the investigators performed this randomized, single-blind clinical trial to~     observe the effects of different doses of ticagrelor and standard-dose clopidogrel on~     platelet aggregation and endothelial function in diabetic patients with stable coronary~     artery disease.~   "
12812|NCT02889536|"~     A parastomal bulge (PB) is a frequent long-term complication after stoma formation. Most~     parastomal bulging occurs within two years of stoma formation but is seen up to 20 years~     post-surgery. A bulge may be relatively obvious or extremely difficult to diagnose, and~     descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'.~     Previous studies report that quality of life as well as physical, psychological and social~     function are affected in patients with parastomal bulging. However, there is a lack of~     knowledge of patients' lived experiences with parastomal bulging. Insight into patients'~     experiences of symptoms in relation to parastomal bulging and the impact on everyday life~     may help identify issues of importance from the patient perspective. This, in turn, may help~     professionals to better understand and support patients with PB, and be of help when~     identifying patients' symptoms and determining relevant treatment strategies.~   "
12813|NCT02889523|"~     Phase I of the study is designed to determine the recommended phase II dose (RP2D) for~     tazemetostat in patients treated with R-CHOP 21.~      Phase II of the study is designed to determine the safety of tazemetostat in patients~     treated with 8 cycles of R-CHOP 21 and to determine the complete response rate according to~     Cheson International Working Group (IWG) 2014: Lugano Classification (i.e. Deauville scale~     1-3) after 8 cycles of Epi-RCHOP 21.~   "
12814|NCT02889510|"~     Type 2 diabetes (T2DM) is related to reduced pulmonary function. As experimental studies~     with glucagon-like peptide 1 (GLP-1) have shown an increase in pulmonary surfactant~     secretion, and the GLP-1 receptor has been found in significant amounts in the lung, it~     could be hypothesized that the treatment with liraglutide (a GL-1 agonist) will improve this~     reduced pulmonary function~   "
12815|NCT02889497|"~     This study evaluates the safety,three batches consistency and immunity duration of the~     post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71~     months.This study has two groups:safety observation group and immunogenicity observation~     group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2~     epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be~     randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.~   "
12816|NCT02889484|"~     Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national~     spine registries in Sweden, Norway and Denmark, there is a 30-60% difference in surgical~     incidence between these countries. The cause for this difference is not known. It may~     reflect a difference in incidence of lumbar disc hernia, but with a similar socio-economic~     and ethnical background in these countries, it is more likely that the differences are due~     to varying surgical indications. Comparing indications for surgery, patient reported outcome~     and factors predictive for outcome after surgery for lumbar disc hernia in these countries~     could provide information about optimal indications for surgery.~      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between~     these countries, (ii) there are no differences in indications for surgery between these~     countries and (iii), factors that predict outcome are similar in these countries.~      Method of research: By using data from three Nordic national spine registers, we will~     compare baseline data, indications for surgery and patient reported outcome one year after~     surgery for lumbar disc herniation. Register based studies have advantages such as large~     sample sizes, reflecting real life, but they also have limitations such as lower follow-up~     rates than clinical trials. A non-response analysis will be performed to take this into~     account.~   "
12817|NCT02889471|"~     110 patients with common bile duct (CBD) stones and had one or more anther preoperative~     predictors for high risk for difficult cholecystectomy admitted to departement of surgery of~     Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient~     divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP~     after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done~     within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and~     methylene blue injected at the end of the procedure to detected any leak in NB group~   "
12818|NCT02889458|"~     Introduction: With population ageing and increasing Westernization breast cancer continues~     to be important health conditions among women in Hong Kong. Greater collaborative research~     efforts are needed to examine the questions about population screening for breast cancer,~     the aetiology of such lesions and outcomes of breast cancer during survivorship period.~     There is a lack of locally-relevant models for assessing breast cancer risk. Contribution of~     novel genetic factors to breast cancer, identification of the key and functional alleles in~     gene regions associated with risk of breast cancer as well as gene-environment interaction,~     requires further investigation in Chinese population. Prognostic research studies in the~     West may not be readily applicable to the Chinese population.~      Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local~     Chinese by using case-control and cohort study design in the health care setting in Hong~     Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and~     to build infrastructure and biobank for breast cancer surveillance. We will follow up cases~     prospectively as a survivor cohort.~      Methods: A hospital-based case-control study and a prospective survivor cohort study will be~     conducted. Consecutive incident breast cancer and DCIS cases (n=3,500) within a 24-month~     period in Hong Kong will be recruited from public hospitals, private hospitals and private~     practices; and controls will be selected by frequency-matching on factors such as age and~     hospital/clinic setting. Cases will be prospectively followed up over a 2-year period, and~     data collection will occur at baseline (within 24 weeks of diagnosis), 6 months, 1 and 2~     years following baseline assessment. Biologic samples (including both blood, and tumour and~     normal breast tissue samples from the cases, and blood samples from the controls) will be~     collected for later genetic and molecular study including WGS, GWAS, gene-environment~     interaction and molecular functional studies. Depending on availability of pathology samples~     and resources, additional studies such as tissue microarray block production will be~     considered and performed in future. Data will be analysed by traditional regression, EWAS~     and genetic association methods, whenever relevant.~      Public Health Implications: The repository of clinical, radiological and biological~     materials assembled through this case-control study will serve as a common, publicly~     accessible platform for subsequent functional analysis and scientific interrogation. The~     case-control findings would offer an improved understanding to the state of the science on~     aetiology of breast cancer in Chinese women. In the genomics analysis, potential refined~     classification of breast tumours may enhance our understanding, detection and follow-up of~     such lesions, as well as enable us to have more informed targeted and personalized treatment~     selection for our women population. The cohort study findings are important for developing~     an effective strategy for the improvement of overall survival and quality of life for the~     cancer survivors in Chinese population.~   "
12819|NCT02889445|"~     4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl~     cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain~     barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not~     transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase~     I/II trials in humans with primary and secondary tumors involving the brain with success.~     Complete remissions in both primary (astrocytomas, GBM) and metastatic lung cancers.~      This trial is open for pediatric and adolescent subjects with advanced cancer - brain~     involvement is not required.~   "
12820|NCT02889432|"~     Orthognathic surgery is commonly performed for the treatment of dentofacial deformities.~     Yet, one of the most prevalent and long-term complication encountered is neurosensory~     disturbance thus impairing sensation to parts of the face. In Hong Kong, it has been~     reported that in patients receiving orthognathic surgery, 5.9% experience long-term~     neurosensory disturbance post-surgery.~      Melatonin is a neurohormone that is produced and secreted by the pineal gland in the brain.~     Its main physiological role in humans is to regulate sleep. Oral Melatonin supplements is~     also used in the management of jetlag and other sleep disorders. Recently, animal and human~     studies have shown Melatonin to improve tolerance to pain and to have a neuroprotective and~     neuroregenerative effect after nerve injuries.~      Hence, it is hypothesized that peri-surgical oral Melatonin supplement can improve~     neurosensory recovery after orthognathic surgery~   "
13049|NCT02886442|"~     This study investigates the impact of real output on the adhesion of two adhesives.~   "
19127|NCT02806908|"~     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate~     the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to~     narcolepsy.~   "
12821|NCT02889419|"~     KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to~     estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the~     realization of self-catheterisation (SC) for patients affected by multiple sclerosis with~     severe to moderate disability.~      Secondly, the study aims to :~        -  Estimate the effect of underwear on quality of life, tiredness linked to the act,~          comfort in the realization of SC, complications with SC, third party intervention ;~        -  Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd~          week of evaluation ;~        -  Measure if the patient reused underwear and if he bought it at 6 months and at 1 year~   "
12822|NCT02889406|"~     In a recent study, we have demonstrated that the motivational therapy approach to treat~     childhood obesity is highly effective at clinical and metabolic levels. This efficacy has~     been proved in a clinical outpatient setting. However, a standardized collaborative approach~     between the clinic and the primary care services would allow a faster and easier approach to~     childhood obesity treatment. Furthermore, this motivational and educational intervention~     would benefit from the current technologic facilities, the long term effect of the education~     at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that~     would be useful specially in low income families (with a higher prevalence of childhood~     obesity).~      The aim of this study is assessing the clinical and metabolic efficacy of a family~     intervention, coordinated between the clinical and primary care services from the Tarragona~     health-care region, using a motivational therapy at individual and group levels, which~     involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese~     child.~      The design will be a clustered randomized control trial, with an intervention group that~     will receive a multicomponent motivational and educational plan which will be compared to a~     control group receiving the usual recommendations performed in primary care centres (n=167~     per group). The treatment of both study groups will last 12 months and will be performed at~     the primary care centres. In parallel, the study team will validate the methodology used to~     assess body composition in obese children as well as the changes produced by the~     intervention.~   "
12823|NCT02889393|"~     The purpose of this study is to determine whether teduglutide is safe and feasible to be~     given for the treatment of enterocutaneous fistula (ECF). We hypothesize that the drug will~     be well-tolerated and will improve the volume of daily ECF output as well as improve the~     functional quality of life.~   "
12824|NCT02889380|"~     This is a multicenter retrospective study in good prognosis Chinese patients. Data will be~     collected from infertile women who underwent first in vitro fertilization (IVF)/intra~     cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist~     (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with~     clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than~     35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10~     milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30~     kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and~     the total dose of Gonadotropin used no more than 2500 IU in current cycle. No~     intervention(s) will be administered on the subjects. Data required to investigate the~     factors associated with the pregnancy outcome of GnRH antagonist IVF cycle will be collected~     from the subjects' medical records into database through electronic data capture system and~     analyzed.~   "
12825|NCT02889367|"~     The purpose of this study is to determine the relationship between the plasma concentrations~     of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate)~     using exposure-response (ER) analysis.~   "
12826|NCT02889354|"~     The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for~     feasibility and acceptability in a pilot study with a single group design. The study also~     evaluates measurements and recruiting possibilities, and effects of the intervention.~     Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for~     participation in an RCT at psychiatric outpatient units, 2. The measurements in the study~     are feasible and reasonable in regards to patient characteristics; that is, the patients are~     responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible~     in terms of treatment completion, compliance to home assignments, and credibility and~     relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The~     CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress,~     depression, and anxiety, and improves quality of life.~   "
12827|NCT02889341|"~     Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after~     one months and after 2 months taken Docosahexanoic Acid or placebo.~   "
12828|NCT02889328|"~     Randomized, placebo-controlled, phase III study of regorafenib 160 mg once daily on~     intermittent dosing schedule of 3 weeks on treatment followed by 1 weeks off demonstrated~     the significant benefit of regorafenib in terms of PFS in patients with GISTs who had failed~     to both imatinib and sunitinib. However, there are concerns that tumors and tumor-related~     symptoms may be progressed during off treatment period. Investigators hypothesize that~     continuous dosing schedule of regorafenib might be feasible and effective to prevent disease~     flare on off-treatment period. Based on the results of previous dose escalation study for~     continuous regorafenib dosing, we investigate the 100 mg daily dose of regorafenib in~     patients with TKI-refractory GISTs.~   "
12829|NCT02889315|"~     Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to~     local pain it causes a deterioration of quality of life or even abandonment of treatment.~     The aim of this study was to evaluate the safety and quality of life (QoL) in patients~     treated with treprostinil administration using an implantable Lenus Pro® pump. This is a~     observational study involving patients with PAH treated with a subcutaneous infusion of~     treprostinil with intolerable pain at the infusion site, who were therefore referred for~     pump implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire~     was performed at the time of initiating therapy with treprostinil, before and 2-9 months~     after implantation.~   "
12830|NCT02889302|"~     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and~     evaluate the safety of KPS-0373 in SCD patients.~   "
13527|NCT02879175|"~     After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a~     risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of~     aneurysms.~      Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by~     ruptured intracranial aneurysms.~   "
12831|NCT02889289|"~     This study will evaluate the potential for improving balance for a single individual with a~     history of traumatic brain injury (TBI). The participant will engage in supervised therapy~     using commercial games on the Xbox Kinect. This study will also evaluate the viability of~     improving cardiovascular fitness using this intervention as well. The investigators~     hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable~     way of improving cardiovascular fitness.~   "
12832|NCT02889276|"~     This study will be the first to examine the effects of a functional resistance exercise~     programme that closely replicates daily activities and their effects on quality of life,~     body composition and functional fitness in cancer survivors. This study will also use a~     supervised and group based exercise setting to help with socialisation and confidence with~     an aim to improve the exercise experience. Eligible participants should be 18-90 years old,~     been treated for colorectal cancer (stages I-IV) in the previous 3 months to five years and~     with no limitations to exercise. The study will include a 12-week exercise period where~     participants will be randomly allocated to the control group or to take part in 32~     supervised one-hour group exercise sessions involving exercises to target the whole body at~     a moderate intensity which will take place in the Mountbatten Centre, Pyramids Centre,~     Fareham Leisure Centre or Horizons Leisure Centres. Depending on participants' membership~     status those in the control group could use the centre's exercise referral programme, which~     has a cost attached, or they will be encouraged to meet national physical activity~     recommendations by walking 30 minutes per day on most days of the week. The only difference~     between the two groups will be the supervised group functional resistance training. At the~     beginning and end of the 12-week study period a number of health-related fitness tests will~     be performed to assess health outcomes, such as resting blood pressure & heart rate,~     respiratory function, body fat measures (body mass index, waist circumference and body fat~     %), functional performance measurements, handgrip strength, a 6 minute walk test and~     self-efficacy to regulate exercise and measures of quality of life questionnaires.~     Participants will be provided with their own results and an overview of the whole study~     data.~   "
12833|NCT02889263|"~     The problem of rehospitalizations in the US is well documented but poorly understood.~     Although Medicare compares the rates of rehospitalization across the country, we have found~     no comparison of different countries. This is a first attempt to compare rehospitalization~     in the US with France where national health insurance (NHI) provides easy access to primary~     care but, like the US, policymakers struggle to improve coordination between hospitals and~     community-based health care providers.Although France's NHI system with central state~     intervention differs from the United States' tradition of federalism, private health~     insurance and pluralism, policymakers seek to achieve cost savings and to reform the health~     care system. A recent literature review on avoidable rehospitalization of older persons in~     France cited studies on the topic and relied largely on ones from the US. Starting in 2013,~     the Center for Medicare and Medicaid Services' (CMS) 'Hospitals Readmissions Reductions~     Program' withheld up to 1% of regular reimbursements for hospitals with higher than expected~     (by CMS) rates of rehospitalization, within 30 days of discharge, due to heart attacks,~     heart failure and pneumonia. CMS increased this to 2% in 2014, will raise it to 3% in 2015~     and may subsequently expand the list of conditions for which it will penalize early~     rehospitalizations. Policymakers in France have been reluctant to implement a hospital pay~     for performance system based on a rehospitalization indicator whose validity is a subject of~     considerable controversy. Despite the controversy and differences in approach, a comparison~     of rehospitalizations between the US and France provides a cross-national perspective on a~     timely policy issue facing both countries.~   "
12834|NCT02889250|"~     This is an open label study with a sample size of 6 to develop deep brain stimulation of the~     subcallosal cingulate white matter(SCCWM) for late life depression using an experimental~     medicine approach in which the investigators will program the device based both on 1) a~     neurophysiologic measure of target engagement and 2) safety (defined as lack of~     neuropsychiatric worsening and stable neurocognition).~   "
12835|NCT02889237|"~     This study is designed as a single-blind RCT in 80 postmenopausal women to compare the~     effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two~     daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium~     + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture)~     in terms of calculated bone strength based on analysis of cortical and trabecular bone~     parameters using HR-pQCT, fracture healing and functional outcome.~   "
12836|NCT02889224|"~     Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and~     cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in~     the pathophysiology of Cushing's syndrome.~      The investigators speculate that:~        -  acute or chronic variations in plasma cortisol may induce changes in the activity of~          the ECS~        -  that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol~   "
12837|NCT02889211|"~     The purpose of this study is to help researchers learn about how the brain responds to~     rewards. This study is interested in seeing how these responses differ between people who~     are more and less responsive to insulin in their body, and people with and without~     depression.~   "
12838|NCT02889198|"~     The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with~     Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools~     designed to help child care programs improve their nutrition environment (specifically~     classrooms serving 3-5 year olds) over the course of 4 months.~   "
12839|NCT02889185|"~     This study aims to assess the contribution of the multimodal imaging, combining a routine~     examination using Optical Coherence Tomography (OCT) with an imaging procedure using~     adaptive optics retinal camera.~      This is a feasibility study with a limited number of patients.~   "
12840|NCT02889172|"~     The purpose of this study is apply a Brief Intervention (PST) in Diabetic and Obesity~     patient in primary care of Mexico City to improve their depressive and anxious symptoms and~     stabilization of metabolic variables.~   "
12859|NCT02888925|"~     The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face~     perception by comparison of performances of epileptic patients and control individuals,~     sex-, age- and socio-educational level-matched.~      Secondary purposes are to prospectively evaluate neuropsychological impact of anterior~     temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face~     perception (exploratory study).~   "
12860|NCT02888912|"~     The aim of this clinical trial was to compare the clinical performances of a glass ionomer~     restorative system with a micro hybrid resin based composite in class I and class II~     cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored~     with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).~     Restorations were evaluated at baseline and yearly during 6 years according to the~     modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).~   "
12841|NCT02889159|"~     Chronically photodamaged skin is visually characterized by dryness, wrinkles, brown spots,~     leathery appearance, etc. This happens as a result of excessive exposure to UV light from~     the sun. While the sun's exposure leaves the skin's surface visibly changed, the skin's~     unseen immune system may also be permanently altered as a result of the exposure, making it~     more likely to develop a variety of skin cancers and infections. This study will examine the~     lasting changes in the immune system of the skin caused by UV exposure. Investigators will~     stimulate different aspects of the skin's immune system by giving an injection of Candida~     Albicans (CANDIN®) and histamine phosphate (HISTATROL®), topical applications of imiquimod~     5% cream (ALDARA®) and performing a tape stripping procedure with adhesive tape. The use of~     Candida Albicans (CANDIN®), histamine phosphate (HISTATROL®), and tape stripping are common~     procedures in clinical settings to stimulate skin desired skin responses. Imiquimod 5% cream~     (ALDARA®) is an FDA-approved drug for the treatment of basal cell carcinomas, actinic~     keratoses and genital warts. Investigators will compare the reaction of the skin's immune~     system on a cellular level from skin normally exposed to the sun exposure to an area~     normally hidden from sun exposure.~   "
12842|NCT02889146|"~     The purpose of this study is to verify if a protocol of early and progressive mobility which~     includes the use of technology is able to increase the level of physical activity and~     improve functionality and respiratory and muscular function of Intensive Care Unit patients~     compared with conventional Physical Therapy.~   "
12843|NCT02889133|"~     Primary Hypothesis~        -  The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting~          iron-deficient erythropoiesis will not meet FDA standards for clinical use.~        -  The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron~          repletion will improve significantly and will meet FDA standards for clinical use.~   "
12844|NCT02889120|"~     Prescription of medicines by telephone in French medical call Centres is a part of the~     general practitioners activity.~      This study aimed to described drug prescription by phone (MTP) performed in four medical~     call centers. The primary objective is to evaluate adherence to french practice guidelines~     for the drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective~     is to evaluate the risk/benefit ratio for drug prescription by phone.~   "
12845|NCT02889107|"~     This study aimed to evaluate long term benefits in speech reception in noise, after daily 10~     week use of an assisting listening device (personal frequency-modulates systems) , in~     non-aphasic stroke patients with auditory processing deficits.~   "
12846|NCT02889094|"~     The overarching purpose of this study is to further understand the reasons for and clinical~     implications of persistent HBV infection in patients co-infected with HIV and HBV in the era~     of highly effective antiviral treatment against both viruses.~   "
12847|NCT02889081|"~     The study is a prospective birth cohort study and the purpose is to describe the status of~     maternal key nutrients(eg. folate and vitamin D) supplementation among pregnancies at early~     gestation in Shanghai, to find out the association between the level of serum key nutrients~     and atopic dermatitis (AD) in offsprings during 6 months.~   "
12848|NCT02889068|"~     The purpose is to determine the benefit of next generation sequencing (NGS) targeted on~     genes involved in intellectual disability for etiologic diagnosis of intellectual~     disabilities. In other words, it concerns the number of patients whose etiologic diagnosis~     will be established with NGS and could not with common techniques. Actually, the molecular~     etiology of intellectual disability is crucial to calculate the risk of recurrence and~     allows the perinatal diagnosis to these families.~      Secondary purposes are:~        1. To determine the place of NGS in the strategy of etiologic diagnosis of intellectual~          disability, to determine the order of analyses performed for a patient with~          intellectual disability without clinical signs.~        2. To evaluate the number of variants with unknown significance and thus non-usable for~          genetic counselling without supplementary analysis.~        3. To determine the number of samples that can be at most pooled keeping a good efficacy~          of capture and results with suitable read depth~        4. To determine the possibility of detecting copy number variations (CNVs) in genes of~          interest with NGS~        5. To establish genotype/phenotype correlations for each gene for which a mutation has~          been identified~        6. To optimize the software pipelining for a rapid analysis for diagnosis.~   "
12849|NCT02889055|"~     Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the~     lightest possible sedation strategies, avoiding the administration of benzodiazepines source~     of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion.~     Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane)~     in resuscitation is interesting because their favorable pharmacokinetic even after prolonged~     administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.~      There are two suitable delivery devices sevoflurane in intensive care, both with CE marking.~     The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use~     and reliable. The objective of this study was to evaluate the use of Mirus ™ device in~     trauma resuscitation and cardiovascular resuscitation.~      Specifically, it will use this modality in case of failure with conventional sedation~     products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to~     severe agitation.~   "
12850|NCT02889042|"~     France is one of the European countries with the highest rate of death by suicide, more than~     10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate~     tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by~     an upward trend between 2005 and 2010. However, the most important predictor of death by~     suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV),~     especially benzodiazepines. These IMV, there have been 16% recurrence in the past year and~     21% at 4 years among hospitalized patients. Or a Health Barometer 2005 survey showed that~     58% of respondents with a TS over the last 12 months had not been hospitalized. This type of~     acting out, especially the repeated IMV (IMVr) is underestimated epidemiologically because~     it is an unknown phenomenon and too little screened by health professionals.~   "
12880|NCT02888652|"~     Study on the registration of coronary heart disease patients undergoing PCI in Chinese's~     population. Get the incidence of adverse events in these patients after PCI, a clear type of~     adverse reaction, forms, influencing factors, to establish risk management processes,~     clinical safety and reasonable treatment, and provide the basis for further research and~     reference.~   "
12851|NCT02889029|"~     Management of complex airway stenoses with dedicated tailored stents wrought by 3D~     computer-assisted conception~      Dedicated Airway Stents for Central Airway Stenoses~      DASCAS~      Toulouse University Hospital is the sponsor of this research.~      This research will be conducted with the support of AnatomikModeling and ADERSPOT~        -  Background: Tracheobronchial stent are devices designed to manage central airway~          stenoses of various origins. Their shape and sizes are however not suitable for~          stenosis of complex anatomy.~        -  Purpose: The investigators propose to test the feasibility and safety of treating~          complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted~          conception~      Abstract: Central airway obstruction is currently managed with non-personalized stents,~     which are usually efficient but lead to severe and potentially lethal complications in 10%~     of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents~     seem particularly unsuited for anatomically complex stenosis.~      Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D~     chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically~     improve the tolerance and safety of such prostheses.~      This first feasibility study, dedicated to patients suffering from anatomically complex~     stenosis will test the safety of treating patients with these new approach. It should lead~     to larger studies evaluating these new types of stents in larger indications.~      After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are~     designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The~     stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the~     same terms as pre-existing models.~      Close follow up is then conducted, including clinical evaluation after one week, three and~     six months; spirometry at one week and 6 months and chest CT-scan at one week.~   "
12852|NCT02889016|"~     This study is an investigation of the neurologic, immunologic, and rheumatologic markers of~     Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by~     the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction~     accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include~     anxiety, emotional lability, depression, irritability, aggression, oppositionality,~     deterioration in school performance, behavioral (developmental) regression, sensory~     amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is~     thought to be caused by infection, inflammation, or alternate triggers that is associated~     with a brain response that leads to these symptoms. The purpose of this study is to examine~     specific neurologic, immunologic, rheumatologic, and genomic, components in children with~     the acute-onset of psychiatric symptoms. This research may begin to uncover a much larger~     story of autoimmune processes that are involved in psychiatric disorders of childhood. By~     better understanding the etiologic components of psychiatric phenomenon, future treatments~     may be better targeted to underlying causes.~   "
12853|NCT02889003|"~     Single-center study, prospective, phase II trial.~      The study objectives are :~        -  To assess safety of the combination of Pioglitazone and TKI in CML subjects who~          experience a loss of MMR following a first TKI discontinuation.~        -  To assess survival without loss of MMR over a 12 months period following a second TKI~          discontinuation in subjects who achieve or maintain < MR4.5 with the combination~          Pioglitazone and TKI administered for at least 6 months.~   "
12854|NCT02888990|"~     1. The use of imatinib in combination or in association with chemotherapy is now~          considered as the gold standard for the treatment of Ph+ ALL. The complete remission~          (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of~          imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients~          and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and~          over.~        2. However, despite high CR rates, the progression free survival rate at 12 months of~          patients treated with the combination of imatinib and chemotherapy is 30% to 50%.~          Relapses remain frequent and only patients intensified with allogenic haematopoietic~          stem cell transplantation are in long term remission. This strategy is not fully~          applicable to most patients aged 55 years and over.~        3. Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with~          BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop.~          The exact incidence of the T315I mutation is controversial and can be estimated to be~          near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a~          very strong predictor of relapse.~        4. Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro~          activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317~          mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain~          mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to~          imatinib is 33% and the median progression-free survival is 3.7 months. Progression~          free survival (PFS) rate at 12 months is 22%.~      The goal of this trial is to evaluate the efficacy and the tolerance of the combination of~     dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy~     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a~     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be~     used in this trial with the addition of dasatinib as concomitant therapy during induction~     and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and~     a progression free survival of 60% at 12 months are expected. The patients will be~     prospectively monitored for minimal residual disease and mutation.~   "
12855|NCT02888977|"~     The use of imatinib in combination with chemotherapy is now considered as the gold standard~     for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with~     chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well~     tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90%~     in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+~     ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with~     low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with~     low-intensity chemotherapy is currently initiated within the EWALL centers.~      3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation~     of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the~     EWALL-PH-01 study it could be anticipated that 50 to 100 patients aged more than 55 years~     will be diagnosed during this 6 months period of time. In addition, all the EWALL centers~     are not participating to the EWALL-PH-02 study and thus these centers could be offered to~     treat patient following the EWALL backbone in addition to imatinib. 4. A minimum data set~     will be defined in order to collect the data of the patients treated following the EWALL-PH~     imatinib study. The main recommendation is to follow as close as possible the procedures of~     the EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data~     set. This imatinib treated cohort of patients would be of particular importance in order to~     better define the potential benefit of using one TKI compared to one other. From the end of~     the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were~     treated following the common backbone schedule in combination with imatinib or others TKI.~     Patients not included in clinical trials for other reasons were also offered a treatment~     with the combination of TKIs and backbone low-intensity chemotherapy. The goal of this~     observatory retrospective and prospective is to describe the efficacy and the tolerance of~     the combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy~     (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.~   "
12856|NCT02888964|"~     This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of~     the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®)~     in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e.~     a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European~     Leukemia Net recommendations) after at least 2 years of therapy with imatinib.~      Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase~     (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not~     eradicated by imatinib alone in almost any of the patients.~      Treatment discontinuation in patients treated by imatinib and in complete molecular~     remission for more than 2 years yield molecular relapses within 6 months in half of the~     patients,indicating the persistence of CML progenitor cells. STAT5 expression is required~     for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the~     dysregulated activity of BCR-ABL in CML.~      Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A~     and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential~     therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical~     studies, we went ahead and administered pioglitazone to one patient who suffered from both~     diabetes type II and CML with residual disease after continuous treatment with Gleevec. The~     amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3~     months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9~     months post-treatment, the latest time point assessed. This striking anecdotal result now~     forms the rationale for filing this formal Phase II clinical trial application.~   "
12857|NCT02888951|"~     This study evaluates the amount of fluid remaining in the stomach of diabetic patients after~     a standard fasting period, and compare it with non-diabetic patients coming for elective~     surgical procedures.~   "
12861|NCT02888899|"~     Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The~     prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women~     have been reported. Quality of life in patients with FI is decreased considerably, in a~     similar extent as in patients with ulcerative colitis in relapse.~      Management of FI usually involves a stepwise approach; beginning with more conservative~     strategies and moving on to more appropriately tailored medications, bowel-retraining,~     biofeedback and psychosocial support. Although a combination of these treatment alternatives~     often improves symptoms they are not always successfully. Neuromodulation is a relatively~     new treatment modality for FI that is based on recruitment of residual anorectal~     neuromuscular function pertinent to continence by electrical stimulation of the peripheral~     nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs~     direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation~     technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial~     nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar~     nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve~     may lead to changes in anorectal neuromuscular function similar to those observed with SNS~     but without the need of a permanent surgically implanted device. Tibial nerve stimulation is~     therefore an attractive treatment alternative for FI patients since the treatment is~     well-tolerated and treatment results have been very promising.~      Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation~     (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with~     biofeedback alone. The investigators also aim to study which FI patients have most profit of~     the addition of PTNS.~      Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology,~     University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will~     be mailed to the FI patients and they are instructed to record their FI symptoms, bowel~     habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before~     consideration of enrolment into the study, gastroenterologists assess all the patients'~     medical history and perform a physical examination. Subjects will also have an endoanal~     ultrasonography and the investigators will measure rectal volumes, sensational thresholds~     and anal sphincter function.~      FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in~     combination with biofeedback or biofeedback alone. The treatment will be performed by~     physiotherapists.~   "
12862|NCT02888886|"~     The purpose is to study the correlation between systemic inflammation (serum levels of CRP,~     IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a~     representative cohort of patients with chronic obstructive pulmonary disease (COPD).~      Secondary purposes are:~        1. To confirm the increase of cardiovascular mortality and the importance of~          cardiovascular morbidity in patients with COPD,~        2. To establish the role of various genetic polymorphisms in the correlation between~          systemic inflammation and cardiovascular disorders observed in COPD,~        3. To search for acceleration of aging of cardiovascular system evaluated with carotid~          intima-media thickness when systemic inflammation markers are increased,~        4. To study the correlation between COPD risk factors (tobacco and other food factors),~          change of respiratory functional data and cardiovascular morbi-mortality. In this study~          cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy,~          left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is~          confirmed with standard techniques and independently of this study. Results of clinical~          examination, ECG, echocardiography and /or brain scanner will be collected.~   "
12863|NCT02888873|"~     The aim of this randomized, prospective clinical study was to compare the clinical~     performance of a universal light-curing, ultra-fine particle hybrid composite with a new~     version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.~   "
12864|NCT02888860|"~     It is proposed to carry out the study in three medical or surgical intensive care units~     (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see~     Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will~     be taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over~     the duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be~     assessed in all patients (according to the CIC), and antibodies to yeast glycans will be~     determined by a simultaneous multiparametric analysis involving several families of natural~     or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).~   "
12865|NCT02888847|"~     Compare teeth sensitivity using bleaching protocol with different light intensities (Philips~     Zoom!™ White Speed whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.)~     versus bleaching protocol with the same light intensity (Philips Zoom!™ Advanced Power~     whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.).~   "
12866|NCT02888834|"~     Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general~     population. Adverse drug reactions (ADR) are common in this population. In elderly subject,~     prevalence of ADRs ranged from 4.3% to 63.0%.~      Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their~     preventability.~      Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of~     Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65~     years who presented a serious ADR notified to the Regional Pharmacovigilance Center were~     included in the study.~   "
12867|NCT02888821|"~     A school-based behavioral intervention for Mexican youth with attention/behavior concerns~     (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y~     Tareas para el Éxito [CLS-FUERTE]:) will be pilot-tested in a mixed-method investigation~     with four Mexican elementary schools.~   "
12868|NCT02888808|"~     Obesity is a strong risk factor for GERD. This study assessed the role of obesity among~     patients having erosive GERD and controls.~   "
12869|NCT02888795|"~     Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a~     long time. However the study about the mechanism is scant. The question of biomarkers of~     knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved.~     On this basis, the aim of this study was to characterize the secreted protein factors behind~     the inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.~      10~12 older than 65 years old knee OA patients will be recruited for clinical Western~     Ontario McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee~     joint synovial fluid analysis before and after hypertonic dextrose prolotherapy. The~     expressions of inflammatory factors will be measured by a novel cytokine antibody array~     methodology. The study will evaluate inflammation-related cytokines in patients of knee~     joint synovial fluid. Human Cytokine Antibody Array that allows profiling synovial fluid~     production of anti and pro-inflammatory cytokines simultaneously. Altered levels of cytokine~     from the array membranes incubated with tissue lysates will quantitatively depict as a~     histogram for relative cytokine induction or reduction in the synovial fluid. The cytokines~     messenger ribonucleic acid levels will be quantified by quantitative reverse-transcription~     polymerase chain reaction and proteins expression was analyzed by Enzyme-Linked~     ImmunoSorbent Assay. The WOMAC Index, minimum joint space width, and Human Cytokine Antibody~     Array between before and after interventions will be compared. Differences between groups~     will be determined by the Mann-Whitney U test. For the synovial angiogenesis is accompanied~     with inflammatory feature in knee OA, associations between endothelial growth factor (VEGF)~     expression and VEGF isoforms pattern will be determined with the Spearman correlation.~   "
12881|NCT02888639|"~     The pharmacoepidemiological EPHEYL (Étude PHarmacoÉpidémiologique de l'hYperparathyroïdie~     secondaire en Lorraine) study is a 2-year, open-cohort, prospective, observational study on~     incident SHPT, i.e. newly diagnosed, with a 2 year follow-up, set in the 12 dialysis units~     located in the French region of Lorraine (public or private).~   "
12870|NCT02888782|"~     Patients who are discharged from hospital can be overwhelmed when they suddenly have to~     manage new conditions or medications. These changes can be particularly difficult for people~     on many medications or with multiple health conditions. There is a real risk that this will~     lead to emergency room visits, hospital readmission, and even death. In addition to~     endangering patients, these adverse events are very costly to the healthcare system. The~     good news is that these events can be preventable if patients receive care that is better~     coordinated.~      Patient-oriented research will be conducted to determine if a pharmacist-led medication~     therapy management service can improve health outcomes of 'medically complex' patients~     transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more~     comprehensive service than their community pharmacist would normally provide. The program~     will use a new Pharmacist Clinic service to provide care and support which does not~     currently exist for patients in NL after they leave hospital. After discharge, patients will~     be randomly divided into two groups: one group will receive care as usual from their doctor;~     the other group will have their medications assessed by a clinic pharmacist within one week~     of hospital discharge along with their usual care from their doctor. The two groups will be~     compared to determine whether specialized pharmacist services after hospital discharge is~     satisfactory to patients/providers, improves patient health, and reduces emergency room~     visits, hospital readmissions, and repeat trips to the doctor. If successful, this project~     will help ensure that patients are taking the right medications in the right way, improving~     individual health and making better use of healthcare system resources.~   "
12871|NCT02888769|"~     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to~     evaluate the effectiveness of automated mobile phone text message-based intervention for~     secondary prevention, including lifestyles modification, medication adherence improvement~     and risk factors control among coronary heart disease (CHD) patients without diabetes. The~     participants will be randomized into intervention and control groups in a 1:1 ratio. The~     intervention group will receive 6 pre-designed text messages per week in addition to usual~     care for one year, while the control group will receive usual care.~   "
12872|NCT02888756|"~     iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients~     based on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture~     of APC activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and~     the HIV target antigens contained in HIVACAT to be administered through the intranodal~     route. iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling~     viral replication in the absence of anti-retroviral therapy.~   "
12873|NCT02888743|"~     This phase II trial studies the side effects of durvalumab and tremelimumab and to see how~     well they work with or without high or low-dose radiation therapy in treating patients with~     colorectal or non-small cell lung cancer that has spread to other parts of the body.~     Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability~     of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor~     cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work~     better in treating patients with colorectal or non-small cell lung cancer.~   "
12874|NCT02888730|"~     Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial~     colonization is facilitated by a reduced mucociliary function and some previous studies~     suggest that the microbiology of the upper airways might influence the microbiology of the~     lower airway. The aim of this randomized control study is to demonstrate efficacy of~     antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in~     sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores,~     quality of life and lung function~   "
12875|NCT02888717|"~     The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor~     prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the~     standard treatment for advanced cervical cancer. In case of para-aortic lymph node~     involvement, an extension of radiotherapy fields is recommended.~      A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm~     and which benefited from the expansion of radiotherapy fields was identical to the survival~     of pN0 patients.~      However, due to a specific disease, this technique should not be performed in all patients.~     It is necessary to reliably select patients with retroperitoneal lymph node involvement. For~     this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging~     surgery with a definitive histological analysis.~      So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to~     improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to~     conventional histology.~   "
12876|NCT02888704|"~     This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately~     subacute and chronic atopic dermatitis after an intravenous injection of autologous~     mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine~     clinically proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory~     efficacy of the ADSTEM Inj. at the proper dose.~   "
12877|NCT02888691|"~     The aim of the study is to investigate glycemic control during a low carbohydrate diet~     compared with during a high carbohydrate diet in adults with insulin pump treated type 1~     diabetes.~   "
12878|NCT02888678|"~     This study evaluates whether the integration of an Economic Strengthening program with an~     HIV-prevention education program produce synergistic effects on economic and health outcomes~     for South African youth ages 14-17 years old.~   "
12879|NCT02888665|"~     This phase I/II trial studies the side effects and best dose of doxorubicin hydrochloride~     when given together with pembrolizumab and to see how well they work in treating patients~     with sarcoma that have spread to other parts of the body or that cannot be removed by~     surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin~     hydrochloride together with pembrolizumab may work better in treating patients with sarcoma.~   "
12882|NCT02888626|"~     A single-center prospective, open-label uncontrolled pilot study. Subjects will receive up~     to 7 laser treatments, spaced 1 to 8 weeks apart, and will be followed at 2 weeks (±1 week)~     post-first treatment and 12 weeks (±2 weeks) post-final treatment.~   "
12883|NCT02888613|"~     This study aims to compare the results of two mini invasive surgical approaches in abdominal~     aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with~     transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit~     will be assessed after 30 days.~      The secondary purpose of this study is to assess the life quality and morbi-mortality at 30~     days, as well as at 6 and 12 months.~   "
12884|NCT02888600|"~     This study is a two-arm randomized controlled trial comparing two 8-week stress management~     programs for reducing inflammation and improving well-being among older adults.~   "
12885|NCT02888587|"~     The study has two objectives:~        1. To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts~          from human tissue to produce organoids. These organoids will be used to study the~          biology of innervated sensory epithelial cells.~        2. to collect subject data relating to clinical management and demographic characteristics~          of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind~          visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.~   "
12886|NCT02888574|"~     This study is a placebo-controlled, double-blind, within-participants crossover~     investigation of the effect of intranasal oxytocin on pain and function among women with~     chronic pelvic pain.~   "
12887|NCT02888561|"~     Patients with poor heart function can, in certain situations, have a further weakening of~     the heart muscle such that it becomes difficult to provide enough blood to the brain and~     other organs. In these cases, heart function can be supported by the use of medicines or~     heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a~     drip). Although Dobutamine has been in use for decades and does improve blood flow to the~     organs, previous studies have not shown any impact on recovery of heart muscle function and~     survival. Key to unravelling this discrepancy is to understand the precise effects of~     Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to~     find out whether simultaneous infusion of another drug called Nitrite (naturally occurring~     substance that is found in beetroot for example, much like GTN) can enhance the beneficial~     effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years,~     major advances in technology mean that it is now possible to obtain this information in~     patients undergoing coronary angiography procedures by making detailed measurements of heart~     muscle function and blood flow in the heart arteries using a conductance catheter (measures~     volume and pressure within the main pumping chamber of the heart) and the Combowire (dual~     pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand~     the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen~     supply and oxygen usage through this use of this technology, directly following the patients~     routine coronary angiogram. Patients will have these measurements taken using the technology~     described above during the infusion of both dobutamine and nitrite, inserted through blood~     vessels that reach the heart.~   "
12888|NCT02888548|"~     Upper limb spasticity is currently mainly managed with local toxin treatments. Recent~     studies suggested combining botulinum toxin injections with splinting to optimise~     rehabilitation in spastic patients. However, one study focused exclusively on lower limb~     spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger~     spasticity in children.~      A study was performed in adult patients with upper limb spasticity treated with botulinum~     toxin injections used as primary objective the tolerance for dynamic splinting. The authors~     noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has~     been conducted to date on the splinting + toxin combination in adults.~      Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum~     toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this~     reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days~     after botulinum treatment.~      Based on this principle, we hypothesise that dynamic night splinting applied just after~     botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint~     providing continuous stretching of the wrist and fingers in extension whilst allowing active~     flexion. Night splinting is thought to promote optimal functional use of the paretic upper~     limb during the day and thus prevent learned non-use, which could worsen the spasticity.~      Each patient will receive treatment cycles, whose results will be compared, so that each~     patient will act as his/her own control. The evaluation will be based on the Tardieu scale~     chosen for its greater inter-individual reproducibility and greater reliability to measure~     spasticity.~      The degree of extension of wrist and fingers provided by the splint will be adjusted to the~     patient's clinical condition with the elastic tensioners. The purpose of the splint is to~     maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching~     maximum extension, which could be harmful.~      This protocol is designed to determine whether dynamic night hand splinting combined with~     botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain~     damage.~   "
12889|NCT02888535|"~     Primary immune deficiencies (PID) are characterized by a failure of the immune system that~     is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300~     different inherited rare disorders were described. The occurrence of PID in adult is rare~     and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs~     are based only on expert recommendations and do not include comprehensive symptoms of PIDs.~     Recurrent infections, more aggressive, are the most common mode of revelation of the PID.~     Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic~     granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID.~     The objective of this study was to evaluate the occurrence of unknown PID in adult admitted~     in critical care unit and to determinate if the investigation of PID in patients with severe~     infections or HLS should be routinely performed in MCIU.~   "
12890|NCT02888522|"~     Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment~     of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality~     and occur in about 30% of cases. The occurrence of relapses is important during the first~     three months post-allogeneic transplant, then gradually decreases during the first year~     post-allograft and then becomes weaker. After relapse, therapeutic options include the~     reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy~     or a new transplant. The performance is influenced by the early introduction of treatment~     whose effectiveness is related to the importance of tumor burden. Immunomodulation of~     preemptive strategies have recently been established by decreasing immunosuppression and~     achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.~      The aim of this study is to evaluate the incidence of relapse following the recommendations~     of post-allogeneic transplant immunomodulation of the French society of bone marrow~     transplantation.~   "
12891|NCT02888509|"~     To explore the neural and cognitive mechanisms of depression (including unipolar depression~     and Bipolar disorder) and anxiety using multimodal MRI techniques.~   "
12892|NCT02888496|"~     Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at~     characterizing immunological abnormalities in PMR patients, and to assess the effects of~     tocilizumab therapy on this abnormalities.~   "
12893|NCT02888483|"~     The overall objective of this project is to evaluate and validate the accuracy and usability~     of a deployed beta sensor-based system. This is a cross-sectional validation study of 100~     apparently health community dwelling adults aged 60+ years. Participants will perform~     standardized lifestyle, exercise and sedentary type physical activities in a clinic~     laboratory and home setting.~   "
12894|NCT02888470|"~     The aim of the study is to estimate the proportion of intensive care unit patients receiving~     current aminoglycosides dosing regimens as part of their antibiotic therapy and achieving~     the recommended maximal plasma concentration (Cmax) after the first and subsequent~     aminoglycoside doses.~   "
12895|NCT02888457|"~     Rationale~      In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal~     conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in~     infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7~     % in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved~     from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in~     Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease~     (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants < 2 years~     of age. The impact of the current change in PCV-program is hard to predict, but could~     eventually result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A).~      With this unique situation the foundation was laid for a carriage study during which the~     nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the~     nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants~     attending day-care centers (DCC), two populations with high reported pneumococcal carriage.~     Young children are an important reservoir and major source of transmission of bacteria to~     the whole community and thus the preferred population to study nasopharyngeal (NP) carriage.~      Aim of the study~      The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal~     vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus~     in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide~     future pneumococcal vaccine program decisions and vaccine development, and to feed AOM~     treatment guidelines in a PCV-program environment. The study will monitor overall~     pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to~     antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal~     colonizers associated with disease, in particular Haemophilus influenzae, will be studied in~     order to evaluate if changes in pneumococcal carriage impact on the carriage of those~     pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM~     and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or~     AOM recurrence to identify any association with the carried pathogen.~   "
12896|NCT02888444|"~     A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully~     stop smoking after taking varenicline are less likely to relapse back to smoking if they~     continue using varenicline for a further 12 weeks~   "
12897|NCT02888431|"~     The purpose of this study is to determine the correlation between pH, base deficit, and~     lactate values when comparing venous and arterial blood samples in the pediatric population.~   "
12898|NCT02888418|"~     This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine~     (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17~     years old and preliminarily explore the immunogenicity.~      135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of~     9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15~     women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30~     women and 30 men in vaccine group and 15 women and 15 men in placebo group.~   "
12899|NCT02888405|"~     The present study sought to investigate the effects of acute dietary changes on estimates of~     body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body~     weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of~     carbohydrate) were examined.~   "
12900|NCT02888392|"~     The proposed study will primarily demonstrate the efficacy of kiwifruit as a food~     intervention for the relief of constipation and associated symptoms in functionally~     constipated adults, and those with IBS-C. Secondary measures will show the consumption of~     kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with~     IBS-C.~   "
12901|NCT02888379|"~     A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the~     Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in~     Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity~   "
12902|NCT02888366|"~     This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for~     breast -related symptoms or signs. Breath tests will be performed in order to demonstrate~     that the outcome of mammography results combined with breast test results improves clinical~     sensitivity and specificity in a group that has an increased prior probability of cancer.~     Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™)~     and also with a laboratory-based assay of samples collected into an inflatable bag~     (BreathBag™).~   "
12903|NCT02888353|"~     Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter~     Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic~     Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has~     been established in patients with pacemakers or ICD's but only in patients in whom strict~     vetting procedures were implemented. These vetting procedures were initially developed to~     eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over~     recent years however, objective scientific evidence has failed to support this concern~     raising the question as to whether or not these vetting procedures are necessary.~      Investigators hypothesize that in view of the existing objective scientific data, evolution~     of device technology and the fact that the investigators have scanned more than 2,000~     devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances~     previously excluded from MRI protocols can be safely scanned without prior vetting.~      This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an~     implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike~     previous studies where strict vetting procedures were implemented pre-procedure, All~     patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion~     in the study provided participants meet standard MRI inclusion/exclusion safety criteria.~   "
12904|NCT02888340|"~     The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in~     the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern~     Hospital (ANW). The investigators suggest that the proposed intervention - provision of~     acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt~     the trajectory (and potential cycle) of medication misuse by providing an alternative at a~     critical point of contact within the healthcare system, potentially disrupting the pathway~     from ED visit to opioid usage after discharge.~   "
13528|NCT02879162|"~     The standard or usual treatment for this disease may be chemotherapy or other types of~     treatment to slow the spread of the disease and relieve some symptoms of this cancer.~   "
12907|NCT02888301|"~     This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed~     tomography (CT) in imaging patients with cancer before and after treatment with a therapy~     that activates the patient's immune system (immunotherapy). PET/CT scans give detailed~     pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive~     substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly~     expressed in activated immune cells, making them light up during PET/CT scans. Doctors also~     want to know how 18F-clofarabine is distributed throughout the body before and after~     treatment with immunotherapies.~   "
12908|NCT02888288|"~     The purpose of this study is to evaluate if implementing an adapted Human Immunodeficiency~     Virus (HIV) curriculum plus mental health intervention versus HIV curriculum alone is~     acceptable and feasible and if it improves mental health, antiretroviral therapy (ART)~     adherence, and virologic outcomes among HIV-positive adolescents. HIV curriculum will~     continue to take place prior to the start of the monthly Saturday youth clinic. Mental~     health intervention sessions will take place three times a month for four months in groups~     of eight based on age and gender. Caregivers will attend two sessions to support the youth~     and provide the guardian perspective on caring for HIV-positive adolescents. The~     investigator hypothesizes the mental health intervention will be acceptable, feasible, and~     will improve mental health and ART adherence among participating youth and this improvement~     will be sustained over time.~   "
12909|NCT02888275|"~     Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary~     profile that makes it an attractive anesthetic for pediatric patients with congenital heart~     disease (CHD). The aim of this study was to investigate the renal protective effect of~     dexmedetomidine in the perioperative setting in children with heart disease.~      Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug~     (NoDEX) group.~      The primary objective of this study was to assess the relationship between the use of~     intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric~     patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether~     there was an association between dexmedetomidine use and duration of mechanical ventilation~     or cardiovascular ICU stay.~   "
12910|NCT02888262|"~     This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a~     composite electronic Smartphone-based biomarker and 3) a neurocognitive signature for~     bipolar disorder~   "
12911|NCT02888249|"~     The purpose of this study is to determine whether the abuse liability of cigarettes with~     altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar,~     casings) is reduced relative to standard composition cigarettes.~   "
12912|NCT02888236|"~     A study of LEO 32731 in the treatment of psoriasis vulgaris~   "
12913|NCT02888223|"~     Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively~     randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A),~     or the alternate sequence (group B). All participants who completed the SCT800HA1 study will~     enter the efficacy and safety study (Protocol No.: SCT800HA3).~   "
12914|NCT02888210|"~     To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes~   "
12915|NCT02888197|"~     Non-interventional extension study to investigate VVC recurrence and candida colonization~     following the P2 acute VVC study~   "
12916|NCT02888184|"~     The aim of the study is to identify prognostication predictors of 6-months neurological~     outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia~     (TH).~   "
12917|NCT02888171|"~     The main objective of the study is to compare the impact of oral ferric citrate compared to~     standard of care oral ferrous sulfate on serum iron, percent transferrin saturation,~     ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic~     kidney disease (CKD) and absolute iron deficiency.~   "
12918|NCT02888158|"~     The primary objective of this study is to compare two groups of~     gynecologic/urologic/visceral internes in terms of the time required to perform a~     laparoscopic surgical intervention (nephrectomy) on an animal model (pig).~      The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer~     training with robotic assistance versus (2) Pelvic-Trainer training without robotic~     assistance.~   "
12919|NCT02888145|"~     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who~     have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their~     fertility. The main part of the ovary is preserved, as primordial and primary follicles are~     resistant to freezing / thawing protocols. In the absence of other techniques (in vivo~     maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved~     tissue is currently the only technique allowing fertility to be restored. Autograft is~     possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or~     a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic~     pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to~     the lack of any codified technique for evaluating residual disease (MRD). The team has for~     two years been developing and validating a technique to look for residual disease in~     fragments of ovarian cortex in cases of acute leukemia. This technique is based on an~     original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian~     cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of~     the technique have been demonstrated in an experimental model. This model consists in using~     8 color flow cytometry to look for characterizable leukemia cells added in different~     dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up~     to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found~     by RQ-PCR with the same dilutions. The model tissue came from laparoscopic ovarian drilling~     in patients with polycystic ovary syndrome. The main objective of this project is to~     validate techniques that have been previously codified with different populations of~     leukemia cells that may be characterized. We then aim to adapt and validate this technique~     to look for MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex~     from leukemia patients that are at risk of metastasis. Secondary objectives will be to~     implement procedures for oncological qualification of grafts in cases of malignant pathology~     and to consider the recommendations for using this cryopreserved ovarian tissue through the~     autograft technique for these indications.~   "
12946|NCT02887794|"~     Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the~     population worldwide. Although pathophysiology of this disease remains unclear, a growing~     interest is emerging for low-level sensory function, acknowledging that deficits in early~     stages of sensory processing are related to higher-order cognitive disturbances in~     schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were~     found correlated with disabilities to discriminate psychoacoustic parameters of sounds.~   "
12947|NCT02887781|"~     This study aims to investigate the factors (clinical, care-related and genetic) affecting~     renal outcome in patients with TSC (Tuberous sclerosis complex)~   "
13703|NCT02877914|"~     This study will use a two-stage random sampling design to create a nationally representative~     sample of patients with heart failure (HF) in China. The investigators sought to describe~     the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to~     identify targets for care quality improvement.~   "
12920|NCT02888132|"~     Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms,~     including progressively increasing fatigue, angina, exertional dyspnea, and syncope.~     Conservative medications are used to treat the vast majority of patients. Invasive therapy,~     which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is~     introduced to patients with refractory symptoms or drug resistance. Considering the~     sternotomy and relatively high patients' tolerance required in myectomy, the potentially~     risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic~     septum, and the potential risk of conduction block after these two treatments, the~     development of new minimally invasive approach is warranted.~      Previous researches have illustrated the effectiveness and feasibility of transcatheter~     radio frequency ablation for HOCM patients. By far, there has been no report on~     transthoracic laser-induced interstitial thermotherapy (LITT) for human treatment. Since~     2004, our department has adopted High Intensity Focused Ultrasound, radio frequency and~     laser in solid tumors treatment, including liver tumors and fibroid. Also our center has~     conducted several animal experiments to verify the feasibility of radio frequency/laser in~     septal myocardium ablation.~      The purpose of this study is to lead echocardiography-guided transthoracic radio~     frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment~     plans for HOCM patients, and verify the safety and validity of intervention treatment in~     long term.~   "
12921|NCT02888119|"~     This study aims to develop, evaluate and translate highly accelerated imaging sequences~     (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard~     clinical 3T scanner using novel compression sensing and parallel imaging strategies.The~     overarching objective of the study is to establish a non-invasive imaging biomarker based on~     the development of rapid relaxation mapping with compressed sensing (CS) that will be~     clinically useful for assessment of early Osteoarthritis. A total of 90 subjects including~     30 patients with high risk of developing knee OA, 30 patients with mild OA and 30 healthy~     controls will be accrued.~   "
12922|NCT02888106|"~     Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in~     Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with~     Chronic Viral Hepatitis B with Delta-agent~   "
12923|NCT02888093|"~     Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the~     correction of female pelvic organ prolapse. The original description of this procedure~     included the use of permanent sutures. However, permanent suture use in this vaginal~     application can result in some minor complication such as persistent vaginal spotting,~     vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized~     delayed-absorbable sutures in order to avoid these complications. Retrospective studies are~     conflicting as to whether or not absorbable suture provides as durable an anatomic outcome~     as permanent suture. There are currently no high-quality, prospective studies that have~     evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.~      This study will recruit women scheduled to undergo USLS with or without other prolapse or~     anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable~     suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome~     will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12~     month follow up visit. Subjects and assessors will be blinded.~   "
12924|NCT02888080|"~     The purpose of this study is to assess if ACZ885 will improve lung function in association~     with reduction of tissue inflammation in patients with chronic sarcoidosis.~   "
12925|NCT02888067|"~     The purpose of this study is to determine whether deep neuromuscular blockade provides~     better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal~     cord resections requiring jet ventilation.~   "
12926|NCT02888054|"~     This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose~     Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed~     Healthy Adult Subjects~   "
12927|NCT02888041|"~     According perinatal surveys, induction of labor is performed at more than 20% of pregnant~     women.~      According to a survey on the trigger practices in France, prostaglandins are widely used to~     initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).~      The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal~     deliveries.~      Currently, 25.4% of patients who was not put in work after 24 hours are triggered by~     oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal~     dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses.~      Using a second Propess® is carried out in several maternity hospitals, as reported by the~     survey on the cervical ripening practices in France. This second administration could be the~     solution to reduce the rate of caesarean in France which amounted to 20.8%.~   "
12928|NCT02888028|"~     This study investigates whether an additional remote follow-up of patients with implantable~     cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels~     of anxiety and depression and device acceptance. Patients are randomized to either~     conventional in-office FU only or additional remote surveillance, follow-up duration is 12~     months. The influence of other variables (age, sex,..) is evaluated regarding their~     influence on study endpoints.~   "
12929|NCT02888015|"~     Pt will be provided with a upper extremity exercise program that will be completed daily~     during their session with occupational therapy. During the session the Activity Measure-Post~     Acute Care and an activity tolerance chart will be completed. The data from the outcome~     measures will be used to determine if there is a benefit to completing a daily exercise~     program.~   "
12930|NCT02888002|"~     A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association~     with an outpatient addictions clinic.~   "
12931|NCT02887989|"~     The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control~     sham intervention for a broad and representative group of medical and surgical patients~     with pain. Hospitalized patients will receive specialized VR interventions, administered via~     portable VR headsets, to manage breakthrough pain. Control patients will view content on the~     in-room Health and Wellness television channel. Investigators will follow patients~     throughout the course of their hospitalization and monitor outcomes during and after their~     stays, including pain levels, medication requests, and quality of life.~   "
12934|NCT02887950|"~     For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an~     important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus,~     hypertension and cardiovascular disease), and several studies have shown that the transition~     to menopause is associated with adverse changes in body composition. In particular, it is~     common to observe the accumulation of adipose tissue in the abdominal region which is~     believed to be an important determinant of the increase in cardiovascular risk.~      The first-line strategy for weight management in overweight / obese subjects is the~     modification of dietary habits and lifestyle in terms of physical activity. However,~     nowadays, there is also a growing interest in complementary therapies (i.e. herbal~     supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more~     consistent results. In this context, preliminary evidence supports the potential role of~     some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and~     chlorogenic acid as adjuvants of dietary therapy for overweight.~      These nutrients may be an important therapeutic aid for overweight subjects. However, in~     support of their use, the evidence from good quality trials is limited.~   "
12935|NCT02887937|"~     The overarching goal of the proposed research is to evaluate whether qualitative and~     quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in~     assessing suspicious indeterminate cystic appearing breast masses and ultimately determine~     whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that~     breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology~     obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these~     non-enhancing cystic lesions can be followed and do not need biopsy intervention.~   "
12936|NCT02887924|"~     Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group,~     application of SLI maneuver followed by respiratory support with nCPAP immediately~     afterwards in preterm infants at high risk for RDS would reduce the need for intubation and~     mechanical ventilation in early period and ultimately will improve respiratory outcomes.~   "
12937|NCT02887911|"~     The purpose of this study is to characterize adult subjects regarding their history of~     allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may~     influence asthma severity and control. Assessments include baseline medical history, lung~     function tests, questionnaires and collection of specimens for phenotypic characterization.~   "
12938|NCT02887898|"~     The investigators hypothesize that non-optimal basal-bolus insulin treated patients with~     type 2 diabetes can achieve better metabolic control by counting carbohydrates with~     concurrent use of an automated bolus calculator. Additionally, the investigators propose~     that this intervention will lead to improvement in patient related outcomes.~   "
12939|NCT02887885|"~     Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women~   "
12940|NCT02887872|"~     Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation~     (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic~     stroke in improving ability to perform daily tasks. Method: Four participants with chronic~     stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE)~     five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of~     motion (ROM), and analysis of muscle activation/deactivation during release of grasp through~     electromyography (EMG). Ability to perform daily functional tasks was assessed using the~     Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that~     improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO~     regimen. Ability to perform daily functional tasks improved in all participants. Conclusion:~     Results should be interpreted cautiously due to the pilot nature of the study and small~     participant number. Further research in this area is warranted.~   "
12941|NCT02887859|"~     This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when~     surgically implanted into a leg to improve blood flow in patients with peripheral arterial~     disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.~   "
12942|NCT02887846|"~     Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more~     comfortable than it as non-invasive respiratory support for the prevention of extubation~     failure in preterm with gestational age of 26-32 weeks.~      Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days~     will be included in the study.When patients were Fi O2 < 0,40, Pa CO2 < 65 mmHg, pH> 7.20,~     MAP (mean airway pressure) <7 cm H2O, they will be extubated if statistically~     stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure~     will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is<0.30 at 24 hours~     and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and~     FiO2 < 0.30 at 24 hours and above, free oxygen will be introduced.~   "
12943|NCT02887833|"~     If cancer spreads to bones it can be very painful, especially when trying to move around.~     One of the best treatments is radiotherapy, which has to be given in a cancer centre. Even~     with this treatment, only about half of people will get good pain relief, and that can take~     up to 6 weeks to work fully. If we know who is unlikely to benefit , then we can explore~     other forms of pain relief sooner, without having to go through radiotherapy unnecessarily.~      We have found that there may be a very simple way to identify patients likely to get good~     pain relief, using a test of changes in temperature sensation over the painful bone. This~     study will explore whether this simple bedside test can be used in a community setting to~     identify which patients suffering from cancer induced bone pain will get good pain relief~     from radiotherapy.~   "
12944|NCT02887820|"~     This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG~     algorithm in addition to traditional laboratory tests to guide transfusion and coagulation~     management of ECMO patients.~   "
12945|NCT02887807|"~     Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of~     these patients remains poor with significant mortality and severe neurological sequelae in~     survivors.~      The objective of the present study is to determine whether cyclosporine can improve patient~     clinical outcome after shockable CA. 520 patients with CA will be entered into a~     multicentre, randomized, placebo-controlled study. They will receive one single injection of~     cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint~     (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave~     or absent motor response or extension to the nociceptive stimulation…) will be assessed 7~     days after CA.~   "
12948|NCT02887768|"~     Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label,~     non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart~     adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and~     subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair~     with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial~     performance. This study will interrogate epicardial infarct repair in patients undergoing~     coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial~     infarction as an adjunct to surgical revascularization. Patients will be evaluated for~     markers of cardiac function and left ventricular remodelling using cardiac magnetic~     resonance imaging (MRI). Adverse events will be monitored to ensure safety.~   "
12949|NCT02887755|"~     The purpose of this study is to test a low cost, non-invasive, wearable near-infrared~     spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a~     rehabilitation aid for war-fighters with lower extremity limb loss. This sensor can record~     real-time physiologic data that relates to total fitness capacity and exertion levels and~     may help develop individualized programs on a per-patient basis. The uniqueness of this NIRS~     measurement system is that it provides real-time muscular oxygenation, dehydration, and iron~     status during whole-body exercise, as well as training-induced adaptations. Currently, no~     technology like this has been tested in an amputee population. Successfully validating this~     technology in a wounded warrior population would provide vital information regarding tissue~     perfusion after injury and new opportunities for improving rehabilitation outcomes.~   "
12950|NCT02887742|"~     Epidemiologic Study and Impact Study of a Dialysis Solution Change on the~     Electrocardiographic Profile of Patient~   "
12951|NCT02887729|"~     Genkyst is a regional cohort involving up to nephrologists working in private and public~     nephrology centers in the West of France. It registers clinical and molecular genetic data~     of all consenting patients with ADPKD from this area.~   "
12952|NCT02887716|"~     The objective of this study is to describe the change in the percentage of fat in the lumbar~     spine.~   "
12953|NCT02887703|"~     This study evaluates the effectiveness of a 12-week in home balance training program with~     and without sensory augmentation for individuals with ataxia. Subjects wear a belt while~     performing balance exercises three times per week for 12 weeks. The belt measures body~     motion and has small vibrating elements called tactors mounted inside that when turned on,~     feel like a cell phone set to vibrate. The tactors provide information about body motion and~     indicate when and how to make a postural correction. Subjects will receive six weeks of~     balance training with the tactors turned on and six weeks of balance training with the~     tactors turned off.~   "
12954|NCT02887690|"~     The purpose of this study is to optimize the Defense Advanced Research Projects Agency's~     (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the~     performance, usability, and patient acceptance of the MPL in a clinical setting. This study~     will be a non-randomized limited clinical optimization study. The study will consist of two~     phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure~     twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial~     amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL~     using a virtual limb controlled by signals from surface electromyograms (sEMG). The first~     six trans-humeral amputee subjects and the first six trans-radial amputee subjects with a~     demonstrated proficiency controlling the MPL based on analytical performance metrics will~     enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom~     socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one~     half-hour sessions, working with an occupational therapist and research associates and~     completing both quantitative and qualitative assessments.~   "
12955|NCT02887677|"~     This study is designed to test the hypothesis that the treatment-induced reductions in the~     ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the~     group of placebo.~      It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of~     dapagliflozin versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It~     will be conducted in three centers.~      Potentially eligible patients will be asked to provide written informed consent (Screening~     Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit~     the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible~     patients will be randomized to one of the two treatment arms and will continue with the next~     visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).~      Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated~     by the protocol in V1 and V3 with the Mobil-O-Graph monitor.~      Blood samples will be collected as indicated by the protocol in Screening Visit for the~     measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In~     addition, blood samples will be collected in V1 and V3 for routine hematological and~     biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver~     function parameters.~      Urine samples will be collected as indicated by the protocol in V1 and V3 for the~     measurement of albumin to creatinine ratio.~   "
12956|NCT02887664|"~     Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy~     and lactation for the prevention of preterm birth, beneficial effects on fetal development,~     visual and cognitive development and other functional outcomes of the infants.~      The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty~     acid and inflammation markers in SGA infants compared with appropriate for gestational age~     (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid~     concentrations in cord blood will differ from those observed in AGA and might correlate with~     the level of circulating mediators.~   "
12957|NCT02887651|"~     The purpose of this study is to determine whether a local fractionated radiation therapy~     achieves a better local tumor control after complete surgical metastases resection at 6~     month as compared to observation alone. Further it should be evaluated if cognitive~     functioning and quality of life is similar in both groups.~   "
12969|NCT02887495|"~     The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help~     researchers use clinical data and human biospecimens to investigate why scleroderma patients~     develop certain complications from their disease. Patients with confirmed scleroderma,~     raynauds or positive autoantibodies are invited to participate. This research may help us~     understand how to prevent and treat scleroderma and other diseases.~   "
12958|NCT02887638|"~     Diagnosing and treating posture-related headache (PRH), such as tension-type and~     cervicogenic headache, is seriously hampered because of common features and complex~     interaction of the neurological and musculoskeletal system. Current therapies are therefore~     not as effective and the population of patients with PRH keeps on increasing. The diagnostic~     as well as the therapeutic process need more structure in order to select the most effective~     treatment; thereby contributing to preventive measures. This goal can be achieved through~     fundamental research with a clinically oriented background. Our study starts from a clinical~     problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture~     seems to play an important role in PRH, the first step in the diagnostic process is to~     analyse postural differences between a PRH- and a control-group. In addition, the role of~     the dura mater in the headache-process will be examined. Patients with PRH will be~     classified in homogeneous groups based on these results. In a second phase~     individual-specific treatment programs will be composed. The general treatment-approach of~     postural abnormalities in the past failed because of the heterogeneous patient-populations.~     Sub-classifying musculoskeletal problems has been proven to be successful in the past~     (O'Sullivan & Dankaerts, non-specific low back pain).~      Our study is divided in 2 phases:~        -  phase 1: profile analysis (no intervention, experimental headache-group vs.~          asymptomatic controls)~        -  phase 2: interventional phase (clustered headache-groups, based on the results of phase~          1~   "
12959|NCT02887625|"~     To compare efficacy, safety and durability of combination therapy with pioglitazone plus~     GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus~     sulfonylurea~   "
12960|NCT02887612|"~     Gastric cancer is one of the common malignant tumors in China, with relatively high incident~     rate and mortality among the population. Surgery is the conventional treatment option for~     early and intermediate-stage stage gastric cancer, but postoperative relapse is the major~     issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of~     166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is~     reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new~     biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.~     The present clinical trial aims to elucidate the correlation between the serum ctDNA status~     and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical~     treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical~     index to predict postoperative relapse.~   "
12961|NCT02887599|"~     Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer~     in the world. This is due to high recurrent rate after surgical resection and poor response~     to chemotherapy and radiotherapy.~      Recent studies revealed that peri-tumoral structure and patients' immune status including~     cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While~     past studies focused on oncogenes and tumor suppressor genes, recent studies focused on~     patients' own immunity. Patients' immunity modified by cancer cells is found to be~     correlated to cancer progression and metastasis.~      Natural killer cells, playing an important role in cytotoxic immune system, are revealed to~     be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal~     cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer~     progression and metastasis were accelerated.~      This study sought to find the correlation of patients' cytotoxic immune status to cancer~     progression and status by measurement of NK cell activity in pancreatic cancer patients.~     This would be basic support to construct a prognostic model of pancreatic cancer for early~     metastasis and post operational recurrence.~   "
12962|NCT02887586|"~     Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It~     plays an important role in improving the quality of life among advanced cancer patients.~     Through a randomized controlled single blinded clinical research, we will observe the~     differences of appetite, food intake amount, weight and KPS between the auricular needling~     treating group and control group before and after the treatment. Based on the results of the~     research, we can prove the clinical effectiveness of auricular needling in treating cancer~     induced anorexia and possible mechanism of the method.~   "
12963|NCT02887573|"~     Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages~     of no requirement for sedation and air insufflation.The bowel preparation has a closely~     relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean~     the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.~   "
12964|NCT02887560|"~     The aim of the study is to describe the early adaptation of the right ventricle assessed by~     echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.~      Secondary objectives include change of haemodynamics measured by transpulmonary~     thermodilution and evolution of right heart function in terms of primary graft dysfunction~     grading.~   "
12965|NCT02887547|"~     Gingival Crevicular Fluid samples will be collected using periopapers after accelerated~     tooth movement technique, results will be achieve with cytokine measurements that will be~     done using Luminex Assays and cytometer flow~   "
12966|NCT02887534|"~     A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three~     dose levels in patients with acute low back pain~   "
12967|NCT02887521|"~     This is a study funded by the National Institute of Health. The rationale for the need of~     this research is the lack of any well proven risk-reducing intervention that may decrease~     the morbidity of lung cancer resection in patients with COPD or that may improve their~     quality of life trajectory, a meaningful outcome in the overall disease progression. The~     proposed intervention is unique as it combines exercise and behavioral interventions that~     were pilot tested in a randomized single-blinded controlled design in the proposed~     population and proved feasible and potentially effective. The aim is to test the effect of~     the proposed rehabilitation on length of stay, pulmonary complications and quality of life~     trajectory.~   "
12968|NCT02887508|"~     The goal of this study was to empirically test a newly developed online HIV sexual risk~     reduction intervention (HINTS) among a representative sample of gay and bisexual men living~     with HIV who meet sex partners online.~   "
13711|NCT02877810|"~     The purpose of this study is to determine the impact of an existing tele-emergency care~     network on quality of care, appropriateness of care utilization, patient safety (medication~     errors), and cost effectiveness compared to telephone consultations from a healthcare system~     prospective.~   "
12970|NCT02887482|"~     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.~     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1~     clinical trial of this vaccine which encodes for the premembrane-membrane and envelope~     regions of Zika virus.~      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in~     South America, Central America, and the Caribbean islands commencing in late 2014 or early~     2015. Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome~     in adults and microcephaly and other birth defects among children born to mothers who are~     infected during pregnancy. At present no vaccines or treatments have been approved for Zika~     virus infection.~   "
12971|NCT02887469|"~     This study will investigate efficacy and safety of rapid intermittent correction compared~     with slow continuous correction with hypertonic saline in patient with moderately severe or~     severe symptomatic severe hyponatremia~   "
12972|NCT02887456|"~     The maintenance of primary teeth until their exfoliation has been one of the main purposes~     of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of~     the permanent dentition. Often, injuries or extensive dental caries reach the pulp of~     deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this~     study was to conduct a randomized clinical trial is to evaluate the performance of~     endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.~   "
12973|NCT02887443|"~     This phase I open label study is conducted to assess the potential pharmacokinetic~     interaction of Raxone® with midazolam in healthy male volunteers~   "
12974|NCT02887430|"~     The aim of this study was to investigate whether the eight therapy session with foot~     reflexology can reduce pain intensity when applied as an addition to the standards care of~     low back pain according to the Malaysian low back pain management guidelines.~   "
12975|NCT02887417|"~     Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the~     most frequent immune cells in glioblastoma are tumor associated macrophages, which find~     theirself in an anti-inflammatory (M2) phenotype.~      Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory~     status.~   "
12976|NCT02887404|"~     Investigators plan to study the role of spine surgery analgesic pathways - for procedures~     with high risk of postoperative pain - in improving the quality of recovery~   "
12977|NCT02887391|"~     Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining~     health, quality of life as well as poor nutritional status. Hemodialysis patients must~     follow a very restrictive diet, and many patients do not eat well and usually report poor~     appetites. A new approach to dialysis is being used in some hospitals in Alberta and~     elsewhere, called in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows~     people to receive their dialysis at a hospital or clinic while they sleep. Since this~     in-centre nocturnal dialysis gives people 8-hour hemodialysis treatment 3 times per week (24~     hours of dialysis per week) the patients have better removal of the waste products from~     their bodies than conventional hemodialysis (an average of 12 hours per week). Also of~     importance, when using in-centre nocturnal dialysis, people will have more time during the~     day to work, spend with family, as well as have time to shop for food, to cook and even to~     eat, which in turn will likely result in improvement in the quality of their lives. This~     study will follow 10 patients on conventional dialysis and 10 patients on in-centre~     nocturnal dialysis for 6 months and compare their food intake, muscle mass, weight, body~     mass index (BMI) and nutrition-related lab tests. The purpose of this study is to determine~     whether there is an improvement in the nutritional status of the in-centre nocturnal~     hemodialysis patients compared to the nutritional status of conventional hemodialysis~     patients.~   "
12978|NCT02887378|"~     A cross-over study of the impact of histologic results of bronchial biopsies performed using~     hot clamps compared to bronchial biopsies using standard clamps~   "
12979|NCT02887365|"~     Investigators would like to assess the efficacy and safety of tegafur-uracil in patients~     with stage II MSI-L or MSS colon cancer under metronomic setting for one year.~   "
12980|NCT02887352|"~     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially~     executive functions. The California Card Sorting Task (CCST) assesses specific components of~     problem-solving ability. There is currently no French version of this test. Reims~     neurological department in collaboration with Rothschild Foundation has developed a French~     adaptation of CCST. This version includes three cards packages with two alternate forms to~     control practice effects (test-retest). In order to assess test-retest reliability we have~     to verify the comparability of the three cards packages within one session in MS patients.~   "
12981|NCT02887339|"~     The Ethical, Legal and Social Issues Substudy in relation to the Genotype Tissue Expression~     Project (GTEx) aims to describe tissue requesters' approach to discussions about donation to~     GTEx and to assess the determinants of families' and patients' willingness to donate to~     GTEx. It also explores ethical issues such as privacy, risks, and release of incidental~     findings and recommend best practices for conducting authorizations and training requesters.~   "
12982|NCT02887326|"~     The biomarker study adds to our previous study on biomarkers in tear fluid. In this study~     the investigators examine wether the biomarker levels are in correlation with the disease~     level and duration of disease.~      The questionnaire study focuses on the patients perspective. With a validated questionnaire~     fore keratoconus patient it examine the patients self.-evaluated visual challenges and~     quality of life~   "
12983|NCT02887313|"~     Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally~     advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response~     (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR.~     We aimed to enhance the neoadjuvant treatment, adding mFOLFOX6 during CRT and after~     radiotherapy, to improve the pathologic outcome and the survival outcome.~   "
12992|NCT02887196|"~     Twenty-five women will be followed through their breast cancer treatment. The women will be~     asked to provide their opinions and desires for lifestyle intervention at different times~     throughout treatment. In addition, basic clinical data will be collected . The primary goal~     of this pilot study is to investigate the physical and behavioral changes that occur in~     patients receiving treatment for breast cancer.~   "
12984|NCT02887300|"~     Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can~     be harmful to psychological well being, as demonstrated by the high numbers of Irish~     hospital doctors experiencing burnout. Burnout has been linked to poor healthcare quality,~     medical errors and low patient satisfaction. To prevent further escalation of this problem,~     there is a need for effective stress-reducing intervention, such as meditation. Meditation~     practice has a confirmed positive effect on well being; through greater insight and~     awareness, meditation could help ED staff to become more attentive to and understanding of~     their patients' complaints, enhancing patient satisfaction and safety. However, based on~     current research it is difficult to distinguish between the effects of meditation on well~     being and those associated with bringing people together. There is therefore a need for a~     larger randomised study (RCT) including a participants that receive no meditation~     intervention.~      This pilot study aims to examine the suitability of RCT to assess the effect of mantra~     meditation on burnout among ED staff. The investigators will also examine participant~     recruitment and retention, data management and outcomes assessment methods for well being,~     patient satisfaction and biological markers. There will be two groups: intervention group~     (meditation) and control group (non-meditation). 30 ED staff placed in the intervention~     group will discuss prescribed texts and learn mantra meditation over a 7-week period,~     accompanied by 20 minutes of daily meditation practice. 30 ED staff placed in the control~     group will work in the ED as usual and not receive any texts. Biological samples and~     questionnaires will be obtained at three time points. Participant feedback will also be~     sought through interviews. This study will highlight issues related to participant~     recruitment, retention, and adherence, questionnaires, logistics, and data management and~     pave the way for an efficient, effective, and larger study that will investigate mantra~     meditation as a means of reducing burnout in ED staff.~   "
12985|NCT02887287|"~     The study aimed to prove EEN is effective for inducing early clinical remission, mucosal~     healing, promoting fistula closure and reducing the size of abscess to adult CD patients.~     They plan to include about 50 patients and observe the effect of EEN.~   "
12986|NCT02887274|"~     Persistence of a marked compensatory anti-inflammatory innate immune response after an~     insult is termed immunoparalysis. There is no biomarker available to determine the immune~     status of patient. Thus, the need for early and definite diagnosis of immune status of~     patient with sepsis, as well as the identification of patients at risk of evolving with~     severe organ dysfunctions, is crucial.~      Most important of all, speed is the key to survival. Therefore, it of crucial importance to~     identify which patient characteristic determines the poor prognosis. Early intervention can~     improve the prognosis. Investigators foresee an urgent need to identify predictors for~     mortality in severe sepsis, including clinical factors or immune status. Recently, the PIRO~     model has been proposed as a way of stratifying septic patients according to their~     Predisposing condition, the severity of Infection, the Response to therapy and the degree of~     Organ dysfunction. The immune status may be associated with above model. However, there is~     paucity data addressing this issue. In this study, investigators will also analyze the~     progression of patient condition during treatment and the associated immune status change.~     In the future, Investigators hope the determination of immune status may contribute to this~     model of classification rather than just being used as prognostic markers. Despite the~     advances in the knowledge of the basic processes that trigger and sustain the systemic~     inflammatory response in sepsis, the search for a magic bullet to treat this syndrome has~     been frustrating. The incidence of severe sepsis and septic shock still remains quite high,~     as does its mortality, which has decreased very little over the past decades.~   "
12987|NCT02887261|"~     For esophageal cancer patients,chest CT could provide more accurate staging information and~     eliminated operation that could not achieve R0 resection such as T4 disease. However, the~     variation image quality was usual encountered because of contrast medium was injected via~     peripheral vein. Power injectable port could provide a secure vascular access as~     administration route for contrast medium via central vein. This could provide higher~     intravascular contrast medium concentration and could lead better image quality. This study~     divided into two arms, one group planned to receive power injectable port and another~     received conventional port. The aim of study was tried to identified the image differences~     between different contrast medium administration route and the its survival impact of~     esophageal cancer.~   "
12988|NCT02887248|"~     The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel~     plus gemcitabine given for 6 cycles, followed by maintenance nab-paclitaxel alone, in~     patients with cisplatin-ineligible or cisplatin-incurable advanced urothelial carcinoma~     (UC).~   "
12989|NCT02887235|"~     The purpose of this study is to determine whether medically tailored meals (HDTM) can~     improve quality of life for patients with metastatic cancer.~   "
12990|NCT02887222|"~     Until recently, at Mount Sinai Hospital (MSH), epidural analgesia for labor pain was~     delivered with a pump that could only provide continuous infusion of the freezing medication~     in combination of pushes of medication activated by the patient, a technique called patient~     controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested~     that this continuous infusion of medication is not as effective as we thought, and suggested~     that instead of continuous infusion we should use intermittent programmed pushes. We now~     have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a~     new technological advance based on the concept that boluses of freezing medication in the~     epidural space are superior to continuous epidural infusion (CEI). Recently we switched our~     epidural pumps at MSH, and our new pumps are able to deliver bolus of medication at regular~     intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have~     shown that delivering analgesia in this manner prolong the duration of analgesia, reduce~     motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and~     decrease local anesthetic consumption. We have recently concluded a study at MSH using PIEB~     where we observed excellent results. However, in that study we observed that some patients~     exhibited higher than necessary sensory blocks. We believe that we can optimize the~     technique by using the same interval of the previous study with smaller volumes of the~     intermittent boluses. We also believe that by optimizing the technique we may be able to~     reduce even further the amount of medication used by each patient.~      The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed~     interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of~     women the necessary drug requirements during first stage of labor (EV90), thus avoiding~     breakthrough pain and need for PCEA or physician intervention. We hypothesize that this~     effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).~   "
12991|NCT02887209|"~     Insomnia is a problem for approximately 75% of people living with HIV, which is much higher~     than the 6% to 10% of people with insomnia in the general population. It is currently~     unknown why the rate of insomnia is so high among people living with HIV, and because of~     this, they are often excluded from clinical trials examining the usefulness of cognitive~     behavioural therapy for insomnia (CBT-I), which is recommended as the first-line treatment~     for insomnia. Insomnia is also associated with poorer immune functioning and lower~     medication adherence. The purpose of this study is to examine whether CBT-I is useful at~     reducing insomnia among people living with HIV, and to examine whether this counselling is~     safe to provide to this population. Other purposes are to explore whether reducing insomnia~     will lead to improved immune functioning and medication adherence, to collect feedback about~     people's experiences receiving CBT-I, to examine which psychological and behavioural factors~     are associated with insomnia severity among people living with HIV.~   "
12995|NCT02887157|"~     Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its~     vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study~     utilizes new technology to determine visual and neurological development of very preterm~     infants in the intensive care nursery, during a period of rapid growth of the retina, optic~     nerve and brain. The long-term goal of this study is to help improve preterm infant health~     care via objective bedside imaging and analysis that characterizes early critical indicators~     of poor vision, neurological development and ROP, which will rapidly translate to better~     early intervention and improved future vision care.~   "
12996|NCT02887144|"~     The aim of the current Investigation is to evaluate the safety and performance of SenSura~     test product 1pc flat and convex light compared with commercial SenSura.~   "
12997|NCT02887131|"~     The purpose of this study is to describe normal dynamic computed tomography anatomy of hind~     foot in inversion/eversion movement, and to define diagnostic criteria for subtalar~     instability.~   "
12998|NCT02887118|"~     Quantitative and prognostic evaluation of dense red blood cells in sickle cell children:~     preliminary single center study from the Creteil pediatric cohort.~   "
12999|NCT02887105|"~     The purpose is to determine the relationship between anxiety and cognitive performances in~     patients with acute and chronic phases of cerebrovascular accident (CVA). Data from~     neuropsychological assessment concerning cognitive processes (working and episodic memory)~     sensitive to different dimensions of anxiety will be analyzed.~      The secondary purpose is to evaluate how some neurological (hemispherical lateralization of~     lesions), psychological (depression) and demographic (quality of life) variables can~     increase the effects of different dimensions of anxiety on cognitive processes, during the~     acute and/or chronic phase of CVA.~   "
13000|NCT02887092|"~     Hip and knee osteoarthritis (OA) is an important health problem with a high prevalence and~     significant consequences on functional ability, perceived health, restriction of autonomy~     and handicap. The weight of multimorbidities and their interaction on functional ability and~     perceived health are left unexplored. This project will rely on the cohort KHOALA,~     representative, multiregional, of 881 prevalent cases (symptomatic hip and knee OA).~      Main objective:~        -  to describe the evolution over time of pain, functional ability, social participation~          and quality of life in subjects with hip and knee OA~        -  to identify prognosis factors of disease evolution (socio-demographic, clinical, and~          other health parameters)~        -  to determine interactions with comorbidities, other personal and environmental factors~          (ICF model).~      Concurrent objective: to improve measurement of perceived health specific to hip and knee OA~     by the OAKHQOL by improving its metrologic performances based on item response theory.~      Task 1: To prepare an improved measurement scale, available as a judgment criteria for the~     3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-OAKHQOL Task~     2: Evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design~     to best assess the evolution of perceived health and functional ability over time, and to~     identify stability of deterioration of autonomy. Perspectives: This project targets to~     provide public health deciders with information of good quality to help them manage~     determinants of perceived health in OA subjects, as essential factors to health care~     resource utilization in their various modalities.~   "
13001|NCT02887079|"~     EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in~     infective endocarditis) is a prospective cohort study with a biological collection.~      The main objective is: to re-evaluate the potential value of antiphospholipid (aPL)~     antibodies as predictors of embolic events in IE in the light of the improved current~     knowledge on these aPL.~      The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation~     markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von~     Willebrand factor) will be taken into account in the analysis, and interest in predicting~     embolic risk, alone or in combination with aPL will be investigated.~   "
13002|NCT02887066|"~     The purpose is to build up a data observatory of individuals with thoracic pain evoking~     acute coronary syndrome (ACS). The aim is the characterization of this population of~     patients consulting at emergency department, the evaluation of therapeutic strategies with~     regard to guidelines and the becoming of patients including severe complications and~     mortality.~   "
13003|NCT02887053|"~     The purpose of this study is to optimize clinical MR protocols and to validate MR~     acquisition parameters.~   "
13004|NCT02887040|"~     Patients ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma will be~     enrolled in this study. However, the primary objectives of this study are to 1) compare~     overall survival, the time from randomization to death from any cause, for study subjects~     3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma who receive~     Antineoplaston therapy (Atengenal + Astugenal) + radiation therapy vs. radiation therapy~     alone and 2) describe the toxicity profile (all subjects) for Antineoplaston therapy +~     radiation therapy vs. radiation therapy alone.~      A secondary objective is to compare progression-free survival for study subjects 3-21 years~     of age with newly-diagnosed, diffuse, intrinsic pontine glioma treated with Antineoplaston~     therapy + radiation therapy vs. radiation therapy alone.~   "
13005|NCT02887027|"~     Multiple studies indicate that exercise is effective in treating depressed mood and reducing~     anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in~     individuals with anxiety and depressive disorders, exercise could help reduce these symptoms~     and aid in the overall treatment of these disorders. This project aims to test an ecological~     momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in~     individuals with anxiety or depressive disorders. Previous protocols have tested the~     acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the~     study, focus groups were conducted to explore the acceptability and usability of the~     Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app~     based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6~     healthy participants. Preliminary unpublished findings indicate that the app was acceptable~     and promoted increased physical activity. The aim of this protocol is to test the~     acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood~     in patients with anxiety or depressive disorders.~   "
13006|NCT02887014|"~     To study the impact of providing specific verbal instructions in inpatients (and/or their~     relatives) undergoing colonoscopy on the quality of bowel preparation.~   "
13007|NCT02887001|"~     Incomplete information or poorly communicated to the transitional stages of the patient's~     drug therapy hospitalized cause medication errors. These steps are the admission, transfer~     within the institution and hospital discharge to home or another institution.~      The adequacy of the prescription recommendations of good practice is not always optimal.~      The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more~     and more heavily in health spending and in the prolongation of hospitalization or re~     hospitalization.~      Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its~     effectiveness on these three themes; it seems appropriate to assess this practice in the~     environment of the French health system.~   "
13008|NCT02886988|"~     Linear hypertrophic scar is a common surgical problem that can be difficult to manage,~     especially for the median sternotomy scar. Despite high demand for the early intervention to~     prevent and treat surgical scars, there is yet no universal consensus on satisfactory~     treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in~     medicine for more than 30 years. It induces chemodenervation through acting on the~     presynaptic neuron to prevent release of acetylcholine, which leads to functional~     denervation of striated muscle for about 6 months after injection. The aim of this~     randomized controlled trial is to evaluate the efficacy of Botulinum toxin type A as a~     prophylactic treatment in the early postoperative of median sternotomy for the purpose of~     preventing excess scar formation.~   "
13009|NCT02886975|"~     The purpose of this study is to determine whether low protein diet and very low protein diet~     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney~     disease (CKD , stage 2 to 5).~   "
13010|NCT02886962|"~     Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation~     whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines~     for the hemodialysis patients with atrial fibrillation, the general guidelines apply.~     However, several retrospective studies suggest that these patients do not benefit from the~     oral anticoagulation regarding the risk of stroke and may even experience more bleedings and~     deaths.~      The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic~     risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients~     with atrial fibrillation.~   "
13011|NCT02886949|"~     This study aims to evaluate the effects of thyroid functions on energy homeostasis and~     inflammation.~   "
13012|NCT02886936|"~     The goal of iFIT Prosthetics, LLC® was to create and commercialize a modular, immediate fit,~     fully adjustable, transtibial prosthesis system suitable for mass production using high~     strength injection molded polymer materials. This goal was achieved and the aim of this~     project is now to conduct a feasibility and effectiveness study and to assess the design of~     the device. The investigators will be fitting up to 30 transtibial amputees that are current~     prosthesis users with the iFIT device. Patients will wear the device for 2 weeks and~     evaluate for comfort, stability and ease of use as compared to their conventional device.~     The investigators will also be obtaining socket pressures and gait biomechanics of~     participants wearing both devices.~   "
13013|NCT02886910|"~     This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood~     count, blood culture) and clinical observation by standardized physical examination versus~     the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical~     observation and antibiotic therapy) in the management of asymptomatic infants born at term~     to mothers with suspected chorioamnionitis. The primary outcome of the study is the~     difference in the prevalence of sepsis-related symptoms between the two groups.~   "
13014|NCT02886897|"~     Background: Combinations of dendritic and cytokine-induced killer cell (D-CIK) based~     adoptive immunotherapy and anti-PD-1 antibody may enhance the immune response and stop~     cancer cells from growing.~      Objective: Phase II clinical trial to investigate the safety, clinical activity and toxicity~     of combinations of D-CIK and anti-PD-1 antibody in patients with treatment-refractory solid~     tumors.~      Methodology: Phase II clinical trial in patients with advanced metastatic hepatocellular~     carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung~     cancer,breast cancer and other solid cancers. The D-CIK was isolated from peripheral blood~     of participants,then activated,expanded and incubated with anti-PD-1 antibody before~     infusion. The enough number (1.0-1.5 *10^10 cells) of D-CIK were infused back into~     participants.~   "
13015|NCT02886884|"~     This is a 10 subject trial to demonstrate the safety of allogeneic hMSCs administered via~     infusion therapy for diabetic subjects with endothelial dysfunction.~   "
13016|NCT02886871|"~     The overall goal of this study is to test personalized mobile phone-based physical activity~     interventions among staff members at the University of California, Berkeley. Most physical~     fitness applications for smartphones and activity trackers use a constant goal for the~     number of steps each day. However, if the step goals are dynamically adjusted according to~     past behavior, then the corresponding goals may encourage individuals to increase their~     physical activity level. This study consists of a randomized controlled trial in which we~     are assessing the efficacy of two different algorithms for calculating personalized goals~     for the number of steps each day.~   "
13017|NCT02886858|"~     While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates~     and cognitive side effects limit its long-term use. There is no consensus about optimal~     continuation pharmacological treatments after a ECT course.~      Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse~     rates.~   "
13018|NCT02886845|"~     The purpose of this study is to determine the frequency of two Single Nucleotide~     Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .~   "
13019|NCT02886832|"~     The purpose of this study is to assess the efficacy of a Prostate Health formulation on~     scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation~     will also be assessed.~   "
13020|NCT02886819|"~     Aim: Hypothesis of this study was that WBV activates different receptors or reflex pathways~     depend on vibration intensity. Aim of this study was to test this hypothesis.~      Methods: This study was conducted on 11 healthy adults. WBV was applied at various~     frequencies and amplitudes. The right soleus T-reflex latency was determined before and~     during WBV. WBV-IMR latency of the right soleus was determined using two different vibration~     intensity: weak vibration and powerful vibration. T-reflex latency and WBV-IMR latency were~     determined by using cumulated average method.~   "
13022|NCT02886793|"~     Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension~     (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently,~     pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been~     adequately characterized due to the lack of markers. A better understanding of the~     mechanisms that regulate this proliferative disorder will allow the identification of new~     therapeutic targets for HP.~      The objective of the project is to identify cell proliferative processes in severe forms of~     PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo~     characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs)~     analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs~     and the right ventricle between patients and controls.~   "
13023|NCT02886780|"~     Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and~     response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland~     University hospital has developed a concentrated 4-day treatment format which has been~     evaluated as part of standard care. Next step in the methodological development is to~     conduct a randomized controlled trial where the 4-day format is compared to self-help and~     waiting list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants~     (16 in each group) are ordinary patients (>18 yrs) entitled to care in the specialist health~     care.~   "
13024|NCT02886767|"~     This study examines the effect of skin-to-skin contact between father and newborn on the~     father-neonate attachment relationship. By block randomization, participants were allocated~     to an experimental (n=41) or a control group (n=42).~   "
13025|NCT02886754|"~     Importance: Clinical communication is an important source of medical error and preventable~     adverse events.~      Objective: To determine the effectiveness of proficiency-based progression (PBP) simulation~     training for ISBAR (Identify, Situation, Background, Assessment, Recommendation)~     communication in the deteriorating patient.~      Setting: The study will be conducted in University College Cork, Ireland. Participants:~     Third year undergraduate nursing and fifth year medical students, who are scheduled to~     undertake ISBAR training as part of the National Early Warning Score (NEWS) programme.~      Intervention: Participants will be prospectively randomized to one of three groups before~     undertaking a performance assessment of an ISBAR communication relevant to a deteriorating~     patient in a high fidelity simulation laboratory: HSE group (the national e-learning~     programme only); S group (national e- learning plus simulation training) and PBP group~     (national e-learning plus proficiency-based progression simulation).~      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication~     in the context of an acutely deteriorating patient.~   "
13026|NCT02886741|"~     In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that~     had been shown to prevent surgical site infections (SSI) associated with hip and knee~     arthroplasty. Project JOINTS (Joining Organizations IN Tackling SSIs was a multi-faceted,~     disciplined initiative that used the Rapid Spread Network (defined above), methods and tools~     developed during previous IHI campaigns to influence orthopedic practices and hospitals~     performing hip and knee arthroplasty. Rather than launch nationally as other campaigns have~     done, Project JOINTS was introduced in a cluster-randomized fashion to enable a rigorous,~     independent evaluation of its effectiveness in promoting uptake of new evidence-based~     practices.~   "
13027|NCT02886728|"~     The primary objective of this study is to evaluate the effects of filgotinib in combination~     with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).~   "
13028|NCT02886715|"~     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing~     Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a~     Vehicle Control in the Treatment of Acne Vulgaris~   "
13029|NCT02886702|"~     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing~     Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a~     Vehicle Control in the Treatment of Stable Plaque Psoriasis~   "
13030|NCT02886689|"~     C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory~     rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic~     juvenile arthritis, established under the auspices of national health authorities.~      Its goal is to document safety, effectiveness in routine practice of various therapy,~     including biotherapy, of prescription or non-prescription over 5 years.~      A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI~     > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it~     will be possible to have patients non exposed to biotherapy (non indication, refusal,~     contraindication) compared to patients exposed to biotherapy, and to monitor adverse events~     occurrence as well as effectiveness in routine practice over time, according to~     prescription, maintenance or switch of various therapies.~   "
13031|NCT02886676|"~     Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal~     disease.~      It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC)~     exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and~     leukotriene biosynthesis.~      Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary~     antioxidants level in CP subjects.~      Materials And Methods- The study was a randomized double-blind clinical and biochemical~     trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department~     of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test~     Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals~     for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and~     CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded~     at baseline, 1 month & 3 months.~   "
13032|NCT02886663|"~     This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic~     patients, to restore the vision of patients with homonymous hemianopsia consecutive to~     stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the~     cerebral localization and in 60% of stroke interesting the territory of the posterior~     cerebral artery.~   "
13318|NCT02882932|"~     Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using~     normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load~     after giving lavage with SOS solution and in other group normal saline. SOS is a high level~     disinfectant, non-flammable and no special training is required to handle it.~   "
13033|NCT02886650|"~     When focal epilepsies become drug-resistant, it could be eligible for cortical surgical~     resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed~     during presurgical evaluation. Some of these children can have access to thermocoagulation~     inside the ictal onset zone, at the end of the monitoring and before to remove the~     electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to~     millimetric cortical lesions around the electrodes. The aim is to stop or at least, to~     reduce the seizure frequency for few weeks or months. This could be a benefit for the child,~     and also a confirmation of the ictal onset zone and guide the surgeon. This technique is~     currently used in adult population for years, but remains very rare in children.~   "
13034|NCT02886637|"~     The purpose of the present study is to evaluate the effects of immune function on~     prognositic outcome in critical ill patients with Acinetobacter baumannii infection.~   "
13035|NCT02886624|"~     The purpose of this study is to assess the rate of sustained virological response (SVR) 12~     weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in~     patients with acute hepatitis C genotype1 or 4 and co-infected with HIV.~   "
13036|NCT02886611|"~     The study aims at searching for a genotype-phenotype correlation in patients with a genetic~     pathology of the ocular surface, in order to identify genetic abnormalities associated with~     the most severe clinical situations.~   "
13037|NCT02886598|"~     The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for~     injection under the conditions of general clinical practice in Korea.~   "
13038|NCT02886585|"~     This research study is studying Pembrolizumab as a possible treatment for this diagnosis for~     metastases in the central nervous system (brain and spinal cord).~   "
13039|NCT02886572|"~     The purpose of this study is to determine the effectiveness and efficiency of Single~     Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more~     brain metastases~   "
13040|NCT02886559|"~     Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the~     treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The~     investigators designed a new regimen, including chidamide, decitabine, aclarubincin,~     cytarabine and G-CSF, to treat rrAML.~   "
13041|NCT02886546|"~     Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many~     advantages, including a reduced need for blood transfusion and fewer surgical complications~     compared with conventional open prostatectomy. As this approach is also recommended in~     elderly patients with serious comorbidities, optimal fluid therapy guidance during this~     procedure is important.~      Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV)~     are used to predict and guide fluid therapy during controlled ventilation. These variables~     arise from heart-lung interactions during positive pressure ventilation, which influence~     left ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep~     Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and~     respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by~     changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic~     surgery under these conditions may be questioned. A recent study established that PPV and~     SVV derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict~     fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another~     study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness~     during laparoscopic surgery.~      The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse~     contour analysis, which is quickly and easily calibrated from the Doppler signal. We~     hypothesized that PPV and SVV measured by calibrated pulse contour analysis would be a good~     indicator of fluid responsiveness during laparoscopy with pneumoperitoneum.~      The primary objective of this study was to demonstrate that PPV and SVV measured by~     calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid~     responsiveness during RALP, which involves both pneumoperitoneum and the Trendelenburg~     position. Investigators also assessed the capacity of other dynamic variables (SPV [systolic~     pressure variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and~     corrected flow time [FTc]) to predict fluid responsiveness during RALP.~   "
13042|NCT02886533|"~     Prospective, multicenter, observational study with a three-year inclusion period (from~     January 1, 2012 to December 31, 2015) and a 6-month follow-up~   "
13043|NCT02886520|"~     This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF)~     and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female~     stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the~     other half will be operated with PP ones.~   "
13044|NCT02886507|"~     This is a randomized double-blinded placebo-controlled study to evaluate the effects of~     NSK-SD consumption in subjects with Stage I hypertension.~      The study population will be randomized into two groups, where both groups will receive~     dietary and lifestyle recommendations to help reduce hypertension. One group will receive~     placebo and the other group NSK-SD for 8 weeks.~      The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of~     treatment in the two subject groups.~   "
13045|NCT02886494|"~     A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate~     Efficacy and Safety of BAC in Patient with Alzheimer's Disease or Vascular Dementia~   "
13046|NCT02886481|"~     Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most~     common and most serious complications of thyroid surgery. Neuromonitoring of the inferior~     laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to~     locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle~     which is stimulated electrically at the location of ILN, producing an acoustic and visual~     signal. This is a basic electromyographic technique whose diagnostic and prognostic~     potential for the entire neuromuscular system has not yet been fully explored. The study of~     action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at~     the beginning and end of dissection, notably the decrease in amplitude, could allow a~     diagnosis during the course of surgery making it possible to diagnose lesions of the nerve~     and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral~     recurrent paralysis. It could also enable the surgeon to give a prognosis for functional~     recovery.~   "
13047|NCT02886468|"~     Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.~     Although there are several causes of fatal anaphylaxis, food allergy is one of the most~     common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A~     delay in epinephrine administration may contribute to an increased risk of death. Therefore,~     the World Allergy Organization recommends that, for the treatment of anaphylaxis,~     epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.~      In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg,~     the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the~     weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and~     Jext®.~      Several studies suggest that the needle length needle is sometim~   "
13050|NCT02886429|"~     Postoperative pain is the most undesired consequence of surgery, and if not managed~     adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to~     reveal that postoperative pain is insufficiently managed throughout the first world, let~     alone in the Third World. An American survey over 20 years showed that only one in four~     patients had adequate relief of postoperative pain. This has led recovery room protocols to~     include pain as a fifth vital sign that needs to be addressed before patients are discharged~     to the ward~   "
13051|NCT02886416|"~     The objective is to characterize the viral evolution and viral factors determining HIV~     virulence, the evolution of the HIV reservoir in PBMC and the co-evolution of anti-HIV CD8 T~     cell repertoires. The coordinated study of virus evolution, host responses and~     identification of genetic determinants of virulence should allow to better understand~     mechanisms of HIV pathogenicity and persistence of mutations in viral reservoirs.~   "
13052|NCT02886403|"~     The study investigates the impact real output has on the adhesion of adhesives.~   "
13053|NCT02886390|"~     The purpose of this study is to determine whether remote limb ischemic conditioning(RIC)~     increase the risk of intracranial hemorrhage for the acute ischemic stroke patients who~     received r-tPA thrombolytic therapy.~   "
13054|NCT02886377|"~     To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked~     po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis~     (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.~   "
13055|NCT02886364|"~     The purpose of this mixed methods study is to evaluate the implementation of an adapted Safe~     Childbirth Checklist in a rural hospital in Chiapas, Mexico. The study aims are:~        1. To evaluate the implementation of the adapted Safe Childbirth Checklist using quality~          of care indicators and the perspectives of providers and patients;~        2. To examine changes in the perceptions of disrespectful and respectful practices around~          childbirth among providers before and after a quality improvement program.~        3. To understand how postpartum women and their male partners perceive the care they~          received at the hospitals in Ángel Albino Corzo and Revolución with regard to~          disrespectful and respectful practices, and how, if at all, these experiences compare~          with prior birth experiences in other settings.~        4. To examine trends in proportion of facility-based births in the catchment area of the~          hospital after the implementation of the adapted Safe Childbirth Checklist~   "
13056|NCT02886351|"~     The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In~     concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its~     safety and widespread of its use nitrous oxide is not a potent drug and many times dentists~     fail to gain cooperation in moderate or high anxious children, and the alternatives are to~     use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher~     concentration was not conducted in Pediatry densitery. The aim of this study is to compare~     the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70%~     with 50% parameters, sedation depth, adverse events and cooperation of the child during the~     dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up~     to 70% is a safe and effective sedation method in dental treatment of children.~   "
13057|NCT02886338|"~     External control of capsule endoscopy (CE) by means of an applied magnetic field is a~     possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this~     study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule~     endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum~     in healthy subjects.~   "
13058|NCT02886325|"~     The overall goal is to develop a culturally appropriate and easy to disseminate educational~     intervention documented to improve cancer prevention and increase cancer screening behaviors~     in the rural Midwest.~   "
13059|NCT02886312|"~     This study will evaluate patient comfort and oxygen delivery efficiency when providing~     supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen~     delivery system. The goals of the study are to evaluate different oxygen flow rates and~     oxygen delivery modes. In addition, the investigators will investigate if the system can~     detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators~     will also investigate how well high flow oxygen delivered only during inspiration is~     tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow~     delivered only during the inhalation phase of the breath.~   "
13060|NCT02886299|"~     Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg~     (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their~     dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density~     lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were~     compared before and after 16-week treatment.~   "
13061|NCT02886286|"~     The purpose of this study is to determine whether the local anesthetic bupivacaine delivered~     intrathecally in small doses via PTM self-administered boluses significantly improves the~     breakthrough pain and functional status of patients with chronic intractable pain who are~     managed with an intrathecal drug delivery system.~   "
13071|NCT02886156|"~     Multiple clinical studies have indicated that obstructive sleep apnea (OSA), the most common~     chronic sleep disorder, may affect neurocognitive function, and that treatment for~     continuous positive airway pressure (CPAP) has some neurocognitive protective effects~     against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive~     architecture and function remain unclear. Therefore, this multicenter trial was designed to~     investigate whether and when neurocognitive architecture and function in patients with OSA~     can be improved by CPAP treatment, and to explore the role of gut microbiota in improving~     neurocognitive function during treatment.This study will be a multicenter, randomized,~     controlled trial with allocation concealment and assessor blinding. A total of 148 eligible~     patients with severe OSA will be enrolled from five sleep centers, and randomized to receive~     CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive~     function, structure and function of brain regions, gut microbiota, metabolites, biochemical~     variables, electrocardiography, echocardiography, pulmonary function, and arterial stiffness~     will be assessed at baseline before randomization and at 3, 6, and 12 months. In addition,~     the investigators will enroll 74 healthy controls and assess all of the aforementioned~     variables at baseline.~   "
13062|NCT02886273|"~     Sudden cardiac death (SCD) accounts for approximately 15 percent of the total mortality in~     industrialized countries, and most commonly results from cardiac arrest due to ventricular~     fibrillation (VF). VF can appear both with identifiable heart disease and as an idiopathic~     arrhythmia. The most commonly underlying heart disease associated with out-of-hospital~     cardiac arrest (OHCA) is coronary artery disease (CAD).~      In this study the investigators intend to give a thorough description of the study~     population based on demographic data, clinical information, medical history and biochemical~     parameters. The investigators plan to assess the total number of OHCA cases among patients~     reported to the ambulance service in the local region during the study period, and determine~     the proportion with documented VF. Next the investigators need to evaluate the clinical~     baseline profile of those included in the study as compared to that of the total VF~     population. High sensitivity cardiac Troponin T cTnT) and brain natriuretic peptide (BNP)~     will be added to the baseline data for further classification of the included SCA patients.~      The main aim of the study will be to evaluate the diagnostic value of copeptin in the~     setting of sudden cardiac arrest (SCA).~      As a second aim the investigators intend to evaluate the association between VF and the~     content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cells.~      Furthermore, as vitamin D is associated with n-3 fatty polyunsaturated acids (n-3 PUFAs) in~     the diet, the third aim will be to assess the association between 25-hydroxy (OH)-vitamin D~     and VF. Matched MI patients will be selected for comparison.~   "
13063|NCT02886260|"~     This study aims to:~        1. describe the monitoring of patients treated for spinal disorders.~        2. create a comprehensive database of reliable and readily exploitable quickly to produce~          a library of cross publications between orthopedic surgery and neurosurgical services.~          This database will include clinical, functional , radiographic , educational, social~          and professional data.~        3. obtain a cohort of patients in the comprehensive range of spinal pathologies.~        4. standardize data collection in this cohort with similar national projects.~   "
13064|NCT02886247|"~     The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the~     investigators are interested in both the genetic and non-genetic causes of pancreatic~     cancer. The investigators are particularly interested in finding the genes that cause~     pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have~     another close relative who has also developed pancreatic cancer. This clustering of~     pancreatic cancers in families has yet to be explained; however, the investigators continue~     to identify new familial pancreatic cancer genes that explain this clustering in subsets of~     families. For example, in 2009 and 2012 the investigators discovered that mutations in the~     PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in~     families.~   "
13065|NCT02886234|"~     This study will investigate whether phone-delivered mindfulness training is feasible and~     acceptable for persons living with HIV and whether it may help them improve adherence to~     medications and reduce risky sexual behaviors.~   "
13066|NCT02886221|"~     Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments~     of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion~     within the orthopaedic community. The purpose of this longitudinal prospective study was to~     evaluate radiographic and functional outcomes in patients with mild-to-severe HV who~     underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and~     lateral release.~   "
13067|NCT02886208|"~     This study is a collaboration between investigators and two community partners: a youth~     employment program and an urban farm. The community partners hire 300+ adolescents for~     summer jobs at various organizations. Approximately 120 adolescents will be employed with~     the urban farm site. As one component of their program evaluation plan, investigators will~     evaluate change in BMI of participants. The investigators hypothesize that there will be a~     reduction in BMI of those participants working at the urban farm site.~   "
13068|NCT02886195|"~     The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor~     Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus~     sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth~     Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).~   "
13069|NCT02886182|"~     To date, several studies have manifested that high levels of adrenal corticosteroids and~     oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and~     immune function status changes can result in minimal fluctuations in liver function tests.~     Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum~     period. Peripartum hepatitis flares leading to hepatic decompensation have been~     reported.Therefore, the investigators aim to detect and observe the immune function status~     and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in~     late pregnancy and the postpartum period.To provide a clinical evidence for the~     administration of chronic hepatitis B virus infection pregnant women.~   "
13070|NCT02886169|"~     The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS)~     levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory~     markers and the formation of foam cells, a situation that can have different effects~     depending the type of dietary fat and presence of metabolic conditions such as abdominal~     obesity and insulin resistance.~      Given that the diet of the Colombian population is rich in saturated fats, and taking into~     consideration the general resistance to complex dietary changes, the purpose of this study~     is to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in~     reducing levels of biochemical markers of cardiovascular risk in adults with and without~     abdominal obesity.~   "
13072|NCT02886143|"~     Urinary retention is a common problem, particularly in hospitalized patients. When a Foley~     catheter is removed, a patient must be monitored for urinary retention. The usual method is~     a passive voiding trial where the catheter is removed, the bladder fills with urine and the~     patient is monitored for voiding over approximately 6 hours. Another option is an active~     voiding trial where the bladder is filled with saline before the catheter is removed and the~     patient is immediately assisted to void. This study seeks to determine the effect of active~     vs passive voiding trials on time to hospital discharge, rate of urinary tract infections,~     and rate or urinary retention in the general hospitalized population.~   "
41487|NCT02514122|"~     A randomized double blind control trial to investigate the safety and efficacy of~     subcutaneous ketamine for control of post operative pain in low resource settings.~   "
13073|NCT02886130|"~     In order to attain the elite level on the national scene, volleyball players need several~     attributes. In addition to mastering technical and tactical skills, great jumping ability is~     another important asset. Maximal power output needed to achieve height during a jump~     necessitates coordinated neuromuscular recruitment and muscle mass among others.~     Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases~     acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone~     concentrations, two factors that could theoretically be associated neuromuscular~     transmission and muscle mass.~      However, until now only a few studies have investigated the role of A-GPC in human exercise~     performance. Published results were mixed. One recent study showed that isometric peak force~     was slightly but significantly increased when subjects had ingested a daily dose of 600 mg~     of A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).~      The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher~     dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball~     players.~   "
13074|NCT02886117|"~     The main objective of this study is to determine the capacity of a questionnaire to predict~     a normal balance sheet of haemostasis.~   "
13075|NCT02886104|"~     The surgical and local ablation strategy for the treatment of resectable synchronous and~     metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of~     this study is to compare two treatment strategies in which simultaneous resection of both~     primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous~     CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in~     SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and~     survival.~   "
13076|NCT02886091|"~     Treatment of keloids scars is difficult and controversial. These keloids have a functional~     and aesthetic impact. A lot of treatment are described with a lot of relapses and~     aggravation. Authors report outcomes of the treatment with shaving and cryosurgery~   "
13077|NCT02886078|"~     The primary objective is to investigate the active extension six months after implantation~     of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.~      This is a randomized controlled trial including 70 patients with PIP OA indicated for~     CapFlex arthroplasty.~   "
13078|NCT02886065|"~     This research study is studying a targeted therapy as a possible treatment for Smoldering~     Multiple Myeloma.~      The following intervention will be involved in this study:~        -  Lenalidomide~        -  Durvalumab~        -  PVX-410~   "
13079|NCT02886052|"~     The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy~     (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist~     guided ICBT or to an active control who receives written information on sleep, insomnia, and~     sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment~     compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is~     to evaluate changes in symptoms of complicated grief and depression.~   "
13080|NCT02886039|"~     Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to~     50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity~     : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount.~     The American Academy of Neurology identifies accurate predictors of poor neurologic outcome~     (2): clinical examination findings such as no pupil response, no corneal reflexes, no motor~     response to stimulation and early myoclonus status epilepticus; biologic parameters like~     high neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results~     like flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked~     potentials (SEP) with no response to N20. Brain imaging may provide additional informations~     but not recommended yet. However, these pronotic markers were developed before the~     introduction therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest~     by international guidelines, based on demonstration of improved survival and neurological~     recovery in comatose survivors of CA (7). TH and its associated use of sedative and~     paralytic agent may delay neurologic recovery and affect the optimal timing of prognostic~     variables (8).~      Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally~     accept and recommended and they were created before TH.~      In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH,~     we developped an electroencephalographic score to predict precocity the neurologic outcome~     according to the Cerebral performance category (CPC) (13-14).~      The purpose of this study is to evaluate a simple and objective electroencephalographic~     score helpful to predict neurologic outcome after CA. Then, we would like to create a~     composite score to have a multimodal prognostication.~      Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if~     indicated and then were immediately admitted in emergency room of ICU. All patients were~     intubated and mechanically ventilated. Sedation was performed with continuous infusion of~     midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized~     with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic~     medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive~     seizure.~      Mild TH between 33 -34 °C was performed by active cooling with intravascular device~     (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained~     between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine,~     epinephrine) according cardiac output monitored by echocardiography.~      After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular~     blocking agents were arrested at 35.5°C and sedation at 36.5°C.~      Neurological evaluation performed at 48 hours off sedation included a clinical evaluation~     (Glasgow score, myoclonus status, response to orders, motor response to stimulation,~     brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2,~     Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two~     certified electroencephalographers blind from clinical neurologic outcome.~      Survival and neurologic outcome according to CPC were assessed at ICU discharge and three~     months later.~   "
13081|NCT02886026|"~     This study compare the efficacy of conventional photodynamic (PDD) guided transurethral~     bladder tumor resection in the operating theatre with outpatient PDD guided laser~     destruction of bladder tumors through flexible cystoscopes.~   "
13082|NCT02886013|"~     Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms~     suggests changes in energy metabolism; this variation may be responsible for the development~     of various diseases including obesity. The aim of this study was to identify the presence of~     these polymorphisms in Mexican adolescents with overweight and obesity at high risk for~     developing diabetes. Methods and Results: This was a descriptive cross-sectional study,~     where 71 healthy adolescents (average age of 16) were included. Anthropometric measurements,~     Body mass index, as well as the determination of glucose, insulin and HOMA index were~     calculated from all the patients. The FTO rs9939609 and PPARy rs1801282 polymorphisms were~     determined by real-time PCR.~   "
13083|NCT02885987|"~     The purpose of this investigator-initiated study is to determine whether the use of an~     accessory device called Endocuff can improve colonoscopy quality in patients who are~     undergoing average risk colorectal cancer screening. Primary end point is adenoma detection~     rates.~   "
13084|NCT02885974|"~     The purpose of this study is to compare patient tumor tissue before and after treatment with~     chemotherapy plus celecoxib. Investigators will look at gene expression, to see what effect~     celecoxib may have on tumor cells.~   "
13085|NCT02885961|"~     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but~     recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is~     produced as a result and is over expressed in IPF patients, so may be important in~     propagating disease activity. We aim to recruit patients with IPF and then complete FDG~     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans~     pre and post manipulation of the coagulation cascade to assess the role of this biological~     pathway in disease activity. Previous studies from our institution have demonstrated~     increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but~     to date the cells and pathways responsible for this signal have not been identified and thus~     need further exploration.~   "
13086|NCT02885948|"~     This is an investigator led, randomised, double blind, placebo controlled, double arm~     comparator study.~   "
13087|NCT02885935|"~     The investigators examined the effects of 4-week dietary protein intake in mixed meals at~     two levels of protein amount on whole body glucose metabolisms in older adults with~     metabolic syndrome.~   "
13088|NCT02885922|"~     Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this~     study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic~     outpatient, who receiving a new anti-diabetic drugs.~   "
13089|NCT02885909|"~     This study will be conducted in the ward of Taichung Veterans General Hospital. The patient~     with hyperglycemia in hospitalization will be enrolled by glucose management team.~   "
13122|NCT02885480|"~     Describe and analyze routes and modes of care for patients in emergency consultant in~     various emergency care and public psychiatric outpatient devices to provide useful~     information to optimize trajectories taken into psychiatric load on the Eurométropole~     territory upstream and downstream of where they viewed urgently.~   "
13090|NCT02885896|"~     In order to show that tailored pediatric counselling by telephone can reduce the number of~     unscheduled and medically unjustified physicians visits in emergency structures, a~     randomized controlled study is conducted. It compares the proportion of cases which used the~     emergency services or unscheduled consultation according to whether they received (or not)~     nurses' telephone advices from the platform. Indeed, our hypothesis is that the presence of~     nurses responding at the Reception and Control Calls Center inside the Emergency Medical~     Services (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver~     appropriate advice to people calling for benign pathologies they see as urgent and to answer~     questions following specific recommendations - will reduce the number of unplanned and~     medically unjustified consultations in medical emergency structures.~      This platform was set-up in order to show it may be a solution in response to the growing~     demand for pediatric care from the population, helping to reduce overcrowding in emergency~     care facilities. Indeed, promoting home care or only if necessary scheduled consultation~     reinforces the conduct to have when facing a pathology from their child. It will also help~     by reducing unjustified use of emergency structures, improving not only the users' reception~     conditions who actually require support in these structures with less waiting time, but also~     the working conditions for employees who perform there.~   "
13091|NCT02885883|"~     Three groups of patients will be considered: a control group (n = 10); a group of patients~     with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI~     will replace CT-scan usually performed in routine before the procedure (n = 15); a group of~     patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with~     gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D~     gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with~     the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution~     2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA~     relaxation times. Argus software will be used for post-treatment imaging. Quantitative data~     will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed~     between the three groups. Statistics will be performed with SPSS software in bilateral~     analysis and a value of p < 0.05 will be considered as significant.~   "
13092|NCT02885870|"~     The spinal cord is a common site for the development of several neurodegenerative~     neurological disorders (spinal muscular atrophy or SMA, amyotrophic lateral sclerosis or~     ALS, X-linked spinal bulbar muscular atrophy or SBMA). In different proportions, these~     diseases involve axonal loss in large funiculi of the spinal white matter, their~     demyelination, and loss of ventral horn motor neurons or motoneurones of the spinal gray~     matter. The lack of specific biomarkers of these macro and microscopic spinal damages, makes~     it difficult the differential diagnosis and monitoring of these diseases.~      Techniques to explore non-invasively the human central nervous system, such as magnetic~     resonance imaging (MRI) and electrophysiology, are potential tools to extract specific~     biomarkers of spinal damages. However, imaging techniques are still poorly developed at~     spinal level for technical (specific antennas), anatomical (size of the spinal cord,~     vertebrae) and physiological reasons (cardio-respiratory movements). However, recent~     advances in the field of spinal cord imaging allowed to extract quantitative data on neuron~     loss, axonal degeneration and demyelination in different spinal pathologies whether~     degenerative (ALS or SMA) or traumatic (SCI). Correlations were found with clinical data,~     and in ALS patients, the changes in MRI metrics over time paralleled the functional~     deterioration. The electrophysiological techniques are used since a long time, leading to a~     good knowledge of the neurophysiology of human spinal cord. In addition, electrophysiology~     indirectly provides data at a microscopic scale, providing information on the excitability~     of spinal neural networks and giving an estimate of the amount of functional neurons.~      By combining these techniques for the investigation of human spinal cord in vivo, the goal~     is to extract new biomarkers using as study models, diseases of the spinal cord affecting~     differentially the white and the gray matter (SMA, SBMA and ALS).~      At first, new methods of diffusion MRI and modelling will be performed in healthy subjects~     to assess the axonal density and diameter of the fibers in the white matter. The anatomical~     imaging T2 will measure the geometrical parameters of the spinal cord such as its surface~     and/or volume at a given vertebral level. Thanks to imaging, we will construct via methods~     of segmentation and image processing, an atlas of the spinal cord that will allow to locate~     spatially spinal atrophy in patients. After this phase of validation, A study of patients~     will be conducted using these new MRI techniques, in addition to those already developed in~     the laboratory. The contribution of electrophysiology will be to assess more accurately the~     microscopic damage. Quantitative data from imaging and electrophysiology will be correlated~     with clinical data in order to extract the most relevant biomarkers.~      This project has thus a methodological interest by proposing the development of new methods~     to assess the human spinal cord, at both macro and microscopic levels. These methods are~     based on the development of the techniques developed at spinal level and which are already~     applicable to human pathologies. The original combination of imaging and electrophysiology~     will also enable us to further analyze the human spinal cord, both anatomically and~     functionally. This project has an important clinical value for the extraction of biomarkers~     in diseases where there is an unmet need for diagnosis, monitoring, prognosis and evaluation~     of new therapies.~   "
13093|NCT02885857|"~     Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of~     patients with chronic kidney disease.~   "
13094|NCT02885844|"~     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be~     created long enough for safely testing changes in human perception and behavior. In addition~     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present~     another unique opportunity to test the same responses to hypergravity and back to 1G.~      Spatial orientation perception is a critical subsystem that is used by the central nervous~     system in the control of vehicles and other complex systems in a high-level integrative~     function. Evidence from space flight research demonstrates that spatial orientation is~     altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke~     2008), transitions corresponding to mission phases particularly critical for crew safety and~     mission success. Accurate perception of self-in-space motion and self-motion relative to~     other objects is critical for successful operations that involve motor control e.g. doing an~     extra-vehicule activity or piloting the spacecraft. To date, there is only limited~     operational evidence that these alterations cause functional impacts on mission-critical~     operations and control capabilities. Immediately after space flight, most crewmembers have~     reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or~     other symptoms of motion sickness), and frequently manifested by lack of coordination,~     particularly during locomotion The hypothesis is that alteration in sensorimotor performance~     induced by inverted vision is gravity depend: maximum alteration during hypergravity,~     intermediary alteration during normal gravity, minimal alteration during weightlessness.~   "
13095|NCT02885831|"~     The aim of this study is to prove the improvement of pubo-femoral distance by early~     abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a~     clinical stable hip but an abnormal hip ultrasonography).~   "
13096|NCT02885818|"~     Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential~     effects on B cells are not well described. This study will assess the effects of abatacept~     therapy on the phenotype and function of peripheral blood B cells in patients with RA.~   "
13097|NCT02885805|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
13098|NCT02885792|"~     Schizophrenia is a severe mental illness associated with excess mortality and affecting~     nearly 1% of the population. The average life expectancy for patients diagnosed with~     schizophrenia has been 55-60 years through the last generations in Denmark, while the~     general population has over the same period of time experienced an increase in life~     expectancy. As a result, the standardized mortality rate for patients with schizophrenia has~     increased markedly over the last three decades and is currently a major public health~     concern. Causes of death are mainly cardiovascular disease and patients diagnosed with~     schizophrenia has a relative risk of cardiovascular disease that is about 2-fold higher than~     the general population.~   "
13099|NCT02885779|"~     The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.~      There is however no forward-looking or retrospective study comparing the~     microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access~     celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section)~     in gynecological surgery.~      The objective of this preliminary study is to compare both surgical care in terms of~     morbidity died operating, in adnexa surgeries.~   "
13100|NCT02885766|"~     A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability,~     safety, pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult~     patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which~     is resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL~     gene.~   "
13123|NCT02885467|"~     This is a randomized study investigating whether identification, ligation, and burial of~     superficial branches of the saphenous nerve crossing the surgical field during total knee~     arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to~     standard total knee arthroplasty.~   "
13101|NCT02885753|"~     Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from~     cancer. Between 30 to 60% of patients develop limited or predominant liver metastases.~     Surgical resection of these metastases, only curative treatment is not immediately possible~     in 10-15% of cases. In unresectable patients, current palliative treatments are based on~     systemic chemotherapy associated or not with the targeted therapies (anti-EGFR~     (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was~     paid to intensified treatment regimens in order to improve their efficiency and improving~     the tumoral response rate, the intensity of the response and its earliness correlate with~     improved overall and progression-free survival.~      The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of~     64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who~     have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits~     systemic and especially neurological toxicities, thanks to a greater hepatic clearance.~      In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with~     oxaliplatin has showed promising efficacy results associated with good tolerance from the~     first line onwards. Indeed, we can expect from the Phase II recent data, a control rate~     close to 100%, with high response rates associated with early maturity and depth responses~     as well as prolonged survival. However, to date, in the absence of randomized trial testing~     this combination, this strategy does not have sufficient evidence to be integrated in our~     routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.~   "
13102|NCT02885740|"~     The purpose of this study is to analyze the association of atrial fibrillation onset in~     normal heart and:~        -  Genetic determinants (genes of receptors, enzymes involved in synthesis and~          degradation, genes of bioavailability of coenzymes and nutritional precursors)~        -  Metabolic determinants of adenosine and methionine cycles~        -  Nutritional determinants.~      Secondary purposes are:~        -  Analysis of physiopathologic mechanisms of AF in normal hearts and adenosine~          metabolisms and its interaction with methionine metabolism, according to identified~          genetic determinants~        -  Analysis of blood markers of adenosine and methionine metabolites as phenotypic markers~          of detected polymorphisms~        -  Evaluate the role of adenosine receptors in AF onset~   "
13103|NCT02885727|"~     Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is~     well tolerated and stimulates a clinically significant pancreas-cancer specific immune~     response.~      The primary objective will be to evaluate whether the combination of RT and durvalumab can~     improve median PFS compared to chemotherapy historical control data in metastatic pancreas~     cancer patients who have progressed through first-line chemotherapy.~      The primary intent of RT in this study is to augment a pancreatic cancer-specific immune~     response when given with durvalumab.~   "
13104|NCT02885714|"~     Rotator cuff tear is a very common and disabling condition that can be related to acute~     trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in~     abduction, abduction weakness and night pain. Rotator cuff tear surgery is a~     well-established form of treatment in acute rotator cuff tears, although beneficial results~     have been reported for both conservative and surgical treatment of rotator cuff tears.~     Rotator cuff tear repair surgery involves a considerable amount of re-ruptures, and it is~     possible that the repaired tendon do not heal despite surgical repair. On the other hand~     rotator cuff tears are also found in completely asymptomatic persons and the clinical~     significance of a rupture may be generally lower than estimated. The above-mentioned~     factors, as well as recent research and meta-analysis on the treatment of mainly~     degenerative rotator cuff tears indicate that there is a limited evidence that surgery is~     not more effective in treating symptomatic rotator cuff tear than conservative treatment~     alone. However, these previous research findings cannot be applied directly to traumatic~     tears, although degeneration can be considered always to contribute to the creation of a~     rotator cuff tear.~      During few last decades, despite the lack of evidence on the superiority of one treatment~     over another, the use of surgery to treat this disorder has been substantially increased.~     Treatment expectations are found to be important in predicting patient related outcome~     measures. In addition, surgery itself may produce a profound placebo effect. There are no~     previous placebo-controlled trials on the topic of interest. In order to find out the true~     efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly~     the supraspinatus tendon, the investigators have designed this multi-centre, randomized,~     placebo-controlled efficacy trial.~   "
13105|NCT02885701|"~     The purpose of this study is to determine if any difference exists among 3 different~     postoperative splinting regimens- no splint, removable splint, and plaster non-removable~     splint- following mini-open carpal tunnel release (CTR) surgery.~   "
13106|NCT02885688|"~     The goal of this clinical research study is to learn if adding liquid nutrition therapy that~     is given by vein to standard-of-care treatment for sepsis can help to control sepsis~     symptoms better than giving standard-of-care treatment alone.~      Researchers also want to compare the length of ICU and hospital stay and any side effects~     between these 2 treatments.~   "
13107|NCT02885675|"~     To evaluate the correlation between the value of miRNA related to ARDS and vascular~     endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in~     patients with ARDS.~   "
13108|NCT02885662|"~     To examine antihypertensive effect and safety of CS-3150 in patients with primary~     aldosteronism.~   "
13109|NCT02885649|"~     This pilot phase 0 trial studies how well enzalutamide works before surgery in treating~     patients with kidney cancer. Androgens are a type of hormone produced by the body that may~     cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the~     amount of androgens produced by the body and keep kidney tumors from growing.~   "
13124|NCT02885454|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA)~     ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone~     and ethinylestradiol in healthy female participants.~   "
13125|NCT02885441|"~     Patients with acute pancreatitis will be randomly assigned in either study group to receive~     oral Ketorolac or control group (double blind study).~   "
13126|NCT02885428|"~     The pathophysiological features of myocardial diabetic subject combined with cardiac~     autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent~     myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the~     sudden onset of a myocardial infarction, or even sudden death.~      That is why the investigators want to evaluate the contribution of non-invasive tools to~     stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map:~     Technical myocardial speckle tracking in studying strains overall average left ventricular~     (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress~     echocardiography with dobutamine (ESD)~   "
13127|NCT02885415|"~     the troponin level and ECGs pre and post operative will be used to determined prevalence of~     myocardial injury among patients undergoing gastrointestinal surgery~   "
13110|NCT02885636|"~     The enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction~     (HFpEF) has led to a need to understand the pathogenesis and treatment options for this~     morbid disease. Recent research from the investigator's group and others have shown that~     pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV)~     dysfunction is present in both early and advanced stages of HFpEF.~      These abnormalities in the RV and pulmonary vasculature are coupled with limitations in~     pulmonary vasodilation during exercise. There are no therapies directly targeted at the~     pulmonary vasculature that have been clearly shown to be effective in HFpEF. A recent study~     by Mayo Clinic Investigators has demonstrated pulmonary vasodilation with dobutamine (a beta~     2 agonist) in HFpEF. As an intravenous therapy, this is not feasible for outpatient use.~      In the proposed randomized, placebo-controlled double blinded trial, the investigators seek~     to evaluate whether the commonly used inhaled bronchodilator albuterol (a beta 2 agonist),~     administered through a high-efficiency nebulizer device that achieves true alveolar drug~     delivery, improves pulmonary vascular resistance (PVR) at rest and during exercise in~     patients with HFpEF as compared to placebo. This has the potential to lead to a simple cost~     effective intervention to improve symptoms in HFpEF, and potentially be tested in other~     World Health Organization (WHO) Pulmonary Hypertension groups. PVR is an excellent surrogate~     marker for pulmonary vasodilation and has been used in previous early trials of PH therapy.~   "
13111|NCT02885623|"~     This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid~     cells in patients of hematologic malignancy.~      Tumor cells either express membrane molecules or release tumor-derived soluble factors able~     to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role~     in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an~     important function in the pathophysiology of various forms of cancers. Fkn is the only known~     ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique~     receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+~     myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the~     clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple~     myeloma (MM).~   "
13112|NCT02885610|"~     The purpose of this study is to initially access the safety and effectivity of RC18 combined~     with standard treatment and Placebo combined with standard therapy in subjects with Moderate~     to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.~   "
13113|NCT02885597|"~     The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are~     effective in the treatment of active Rheumatoid Arthritis (RA).~   "
13114|NCT02885584|"~     High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which~     high frequency pulses accumulate to generate a low frequency tidal volume at a controlled~     airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury.~     The goal of our study is to compare, in early ARDS patients, the effects of conventional~     mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment~     and distension evaluated by CT-scan~   "
13115|NCT02885571|"~     This study evaluates whether objective compliance monitoring can increase mandibular~     advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of~     participants will be assigned to objective compliance monitoring group (experimental group),~     while the other will be assigned to subjective compliance monitoring group (control group).~     A physician will prescribe and explain to patients based on data from objective or~     subjective compliance monitoring.~   "
13116|NCT02885558|"~     The purpose of this study is to examine the role of T-type calcium channels in endothelial~     dysfunction observed with ageing.~   "
13117|NCT02885545|"~     Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at~     high risk for stroke. The use of blood thinking medication in dialysis patients is~     controversial and warfarin carries a serious risk for major bleeding.~      The Watchman device may be an ideal therapy for this population as after implantation it~     allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.~   "
13118|NCT02885532|"~     The ability to meaningfully consent intoxicated and chemically dependent patients for~     research has inhibited medical advances in this vulnerable population. A recent pilot~     supported use of the University of California, San Diego Brief Assessment of Capacity to~     Consent tool to assess the capacity of intoxicated emergency department patients to~     participate in research. The objective is to determine the number of intoxicated emergency~     department patients who could correctly complete the questionnaire, and evaluate alcohol~     concentration, sedation and ability to recall participation upon sobriety.~   "
13119|NCT02885519|"~     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care~     (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation~     (VR) intervention for people on sick leave because of burnout, adjustment disorder and~     psychological stress in Denmark~   "
13120|NCT02885506|"~     The First in Human (FIH) study is separated into two parts:~        -  The first part is a Single Ascending Dose (SAD), double-blinded, randomized and~          placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).~        -  The second part is a food effect cohort with an open-labelled, randomized fed/fasted~          cross-over design.~      The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics~     (PK) of P218 in healthy volunteers.~   "
13121|NCT02885493|"~     The strong relationship between falling and severity of cognitive impairment in the elderly~     is well established. The association premorbid gait and executive disorders suggests that~     they are under tension by the same mechanisms. The gait fortiori neurological are fall risk~     factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are~     subcortical origin involving so the basal ganglia. This study is indeed based on the~     assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes~     resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the~     contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with~     cognitive impairment and greater susceptibility to confusional states. The executive~     disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye~     movements, impaired vision contrasts are well established in the degenerative parkinsonian~     syndromes. This study proposes a new approach to assessing gait disorders to define a high~     risk of falling in the presence of parkinsonian walking in the elderly over 75 years.~   "
13128|NCT02885402|"~     Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an~     infection or an inflammatory process that affects millions of people. The first symptoms~     usually appear from 40-50 years and at this point, conventional radiological tests provide~     diagnostic elements relatively late, poorly correlated with pain relief and providing no~     functional information. In this context, there is a real need for imaging techniques for~     early detection of osteoarthritic changes in a still reversible stage for faster support and~     MRI appears to be the tool of choice.~      Conventional proton MRI sequences already allow improved detection possibilities compared to~     conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient~     to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to~     recent technological advances, exploration MRI other nuclei such as sodium is now possible.~     Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss~     and ultimately a gradation osteoarthritic reached.~      This project's main objective is to quantify the biochemical changes (sodium content)~     occurring at different stages of osteoarthritis defined by clinical algofunctional scores~     (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).~   "
13129|NCT02885389|"~     Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters~     with an onset in the first year of life. West syndrome represents a subset of ISs that~     associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or~     regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many~     patients, however, remain without etiological diagnosis, which is critical for prognostic~     purpose and genetic counselling. In the present study, the investigators performed genetic~     screening of 73 patients with different types of ISs by array-CGH and molecular analysis of~     5 genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of~     epileptic encephalopathies, including ISs, as well as MAGI2, which was suggested to be~     related to a subset of ISs.~   "
13130|NCT02885376|"~     The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in~     reducing the severity of oral mucositis secondary to radiation therapy for head and neck~     cancer.~   "
13131|NCT02885363|"~     The main objective of this study is to clarify prospectively prognosis of patients newly~     diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival~     of the following events: death, heart transplantation or hospitalization for cardiovascular~     complications). In a second time, prognosis factors will be identify in these patients with~     LVNC.~   "
13132|NCT02885350|"~     In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will~     be compared when given either intrathecally or epidurally in primiparous parturients during~     early phase of the labour.~   "
13133|NCT02885337|"~     Osteoarthritis leads to reduced independence and quality of life. Total hip replacement is a~     successful and cost-effective surgical intervention to relieve pain and improve functioning~     in patients with osteoarthritis. Research has shown that pre-operative health status~     strongly predicts outcomes including physical function and hospitalization length after hip~     replacement surgery. Frail patients, in particular, are at greater risk of poor~     post-operative outcomes and could potentially benefit from interventions targeting an~     improvement in their health status prior to undergoing a hip replacement surgery. Partnering~     with Young Men's Christian Association (YMCA) and a multi-disciplinary team of healthcare~     providers, this pilot trial will examine the feasibility of a multi-modal intervention for~     frail patients that includes a supervised exercise program, vitamin D and protein~     supplementation, and a medication review. The results of this feasibility study will guide~     the design of a future multi-center study, which if successful, could be developed into a~     routine model of care that is implemented in joint replacement programs across Ontario and~     ultimately improving the lives of frail seniors undergoing hip replacement.~   "
13134|NCT02885324|"~     This pilot will study the feasibility and exploratory efficacy of using Cabozantinib for~     recurrent or refractory high grade glioma for which there are no curative options. Patients~     will also be followed for safety, time to progression, event free survival and overall~     survival~   "
13135|NCT02885311|"~     The purpose of this research study is to develop and test a care model to treat excessive~     drinking and alcohol use disorders in the primary care setting. The goal of this research~     study is to increase the identification and treatment of problem drinking in the primary~     care setting. You are being asked to participate in this study because routine screening and~     assessment conducted at your primary care clinic indicates that you have recently exceeded~     healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.~   "
13136|NCT02885298|"~     Endotracheal intubation is most commonly taught and performed with the patient supine.~     Recent literature suggests that elevating the patient's head to a more upright position may~     decrease peri-intubation complications. However, there is little data on success rates of~     upright intubation in the emergency department. The goal of this study was to measure the~     association of head positioning with intubation success rates among emergency medicine~     residents.~   "
13137|NCT02885285|"~     The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and~     depression in Parkinson's disease. It is well established that exercise improves the motor~     symptoms of Parkinson's disease. However, it is not clear which types of exercise are most~     beneficial for specific non-motor symptoms.~   "
13138|NCT02885272|"~     The goal of this clinical research study is to compare the results during different scanning~     time points after a contrast drug is given for a FDG PET/CT. The contrast drug helps the~     researchers see the images more clearly.~   "
13139|NCT02885259|"~     Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be~     tested in patient witch MMN and currently under maintenance treatment with IVIG for safety,~     tolerability and efficacy.~   "
13140|NCT02885246|"~     The purpose of this study is to assess the prevalence, strain circulation and disease burden~     of seasonal Influenza A and B in Panama, selected countries of Central America and the~     Caribbean from the Year 2010 to 2015.~   "
13141|NCT02885233|"~     This study evaluates the effectiveness of a web-based fall prevention program called Free~     From Falls Online (FFFO) on people with multiple sclerosis.~   "
13142|NCT02885220|"~     The aim of our study is to determine if the goal directed weight loss program improves~     weight loss versus the conventional weight loss program after laparoscopic sleeve~     gastrectomy.~   "
13143|NCT02885207|"~     The knowledge of encephalitis associated with antibodies targeting intracellular antigens,~     and neuronal surface antibody syndromes has expanded considerably in recent times.~      The primary purpose of the investigators protocole is to determine the incidence of~     anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal~     epilepsy of unknown cause to guide the management of these patients.~      The investigators hypothesis is that dysimmune encephalitis is more common than is suggested~     by the current literature, and that sometimes forms of encephalitis dysimmune at minimum~     can be observed only in the form of focal epilepsy without further manifestation associated.~   "
13144|NCT02885194|"~     Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly~     understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS)~     could make a profit on the pain in PD.~      The investigator would drive a study with a follow up of PD patients before and after~     STN-DBS. The pain will be clinically explored by targeted questionnaires and~     electrophysiological through laser evoked potentials.~      The questionnaires are designed to quantify and characterize the pain in these patients.~     Laser evoked potentials will, through repetitive stimulation, study both the functional~     status of the afferent nociceptive pathways, their habituation to repetitive nociceptive~     stimuli, and so better understand any abnormalities of the central processing of nociceptive~     information.~   "
13145|NCT02885181|"~     The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for~     the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active~     RA despite methotrexate (MTX) therapy who had an inadequate response to MTX (either alone or~     in combination with biological disease modifying anti-rheumatic drugs [bDMARDs]).~   "
13146|NCT02885168|"~     The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated~     with dose-response curve is diminished in septic shock and ameliorated by activated protein~     C (APC).~      This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen~     species (ROS) markers and increase of circulating catecholamines.~   "
13147|NCT02885155|"~     The purpose of this study is to determine the prognostic value of echocardiographic~     parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial~     hypertension (PAH).~      A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months.~     In pulmonary fibrosis it has been demonstrated that the variation of clinical and~     paraclinical parameters between 2 examinations has a prognostic interest. In this study the~     prognostic value of variation of some echocardiographic parameters between initial~     examination and echocardiography after 3 or 6 months will be evaluated.~      Another secondary purpose is to create a common database for Pneumology, Cardiology and~     Epidemiology departments with prospective registration of new cases of PAH and follow of~     patients under treatment.~   "
13148|NCT02885142|"~     Local excision for early rectal cancer has proven its feasibility and oncological safety.~     Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal~     carcinomas respectively. Two procedures are currently performed in these early cancers as~     well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven~     its superiority over traditional transanal excision, is a surgical approach associated with~     a 92% R0 excision rate, a survival comparable to radical anterior resection and a low~     morbidity. It consists of a full-thickness excision. The second procedure is a recently~     introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the~     mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates~     than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to~     65% in the subgroup of European series. Though very promising, the role of ESD remains~     controversial in malignant lesions with few published reports. There are therefore 2~     different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve~     the same oncological treatment. So far, only one retrospective single-center study including~     63 patients has compared TEM and ESD in early rectal cancer without finding any difference~     between the 2 procedures, and there are no other available studies comparing TEM and ESD for~     any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for~     early rectal cancer and rectal adenomas for short- and long-term outcomes.~   "
13149|NCT02885129|"~     The main objective is to assess the measurement characteristics (validity, reproducibility)~     and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology~     and rheumatology hospital and liberal and hospital oncology and Infectious disease, by~     following the evolution of patient compliance at D0 and D15.~      The second objective is to assess the sensitivity to change of scale EGOMAC following~     developments compliance 3 months.~   "
13150|NCT02885116|"~     In this study effect of NHF on pulmonary thermodynamic parameters will studied.~   "
13151|NCT02885103|"~     This study will prove to concept of effectiveness of NHF in combination with a nebulizer on~     reversibility of lung function in COPD patients.~   "
13152|NCT02885090|"~     Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations~     in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been~     recently discovered being involved in other forms of RTT. However, at least 5% of typical~     forms and more other atypical forms are not linked to any of 3 genes known to be involved in~     the disease.~      The purpose of this study is to identify new genes involved in molecular etiology of typical~     and atypical forms of RTT.~   "
13164|NCT02884934|"~     Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked~     venous thromboembolism have a high risk of recurrence after stopping anticoagulations.~     Extending anticoagulant therapy for an additional 18 months is associated with a major~     reduction of recurrent VTE; however this benefit tended to be lost after stopping~     anticoagulation during a follow-up period of two years. This risk of recurrentce is likely~     to continuously increase over the years as well as the risk of chronic thromboembolic~     pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome~     (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these~     risks over 6 years of follow-up in patients who have been initially treated during 6 months~     or 24 months (patients included in the PADIS PE and PADIS DVT trial).~   "
13712|NCT02877797|"~     Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper~     GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and~     evaluation of the papilla duodeni major.~   "
13153|NCT02885077|"~     Even with the advances in clinical therapy and percutaneous interventions, coronary artery~     bypass grafting (CABG) is still widely used in the treatment of patients with coronary~     artery disease (CAD). However, it is a complex procedure that triggers important organic~     implications especially on pulmonary function. In relation to the treatment of patients~     undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These~     programs can also be associated with other muscle training measures, among these there is~     inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT~     daily, but there are few studies about the effects of high intensity training loads~     performed on alternate days. In this context, is justified the use of a device such as the~     recent Powerbreathe, which uses higher training loads that would provide greatest benefits,~     whereas the magnitude of the response to training tends to increase with load.~      OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined~     aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity,~     respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and~     endothelial function in patients who underwent CABG in phase II cardiac rehabilitation~     program.~      METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed~     in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa~     Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and~     respiratory muscle strength (spirometry and digital manovacuometry), as well on the maximal~     exercise capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of~     quality of live (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers).~     After the evaluation will be randomly allocated into two groups: the control group will~     perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group~     cardiac rehabilitation associated with the IMT High-intensity. The intervention will last~     twelve weeks for both groups and after this phase patients will be submitted again to the~     assessment tools.~      EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation~     (phase II) after coronary artery bypass surgery patients.~   "
13154|NCT02885064|"~     This study is observational only and is intended to evaluate changes in the makeup and~     function of bacteria naturally present in the mouth during treatment with braces to~     straighten teeth.~   "
13155|NCT02885051|"~     The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain~     Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).~   "
13156|NCT02885038|"~     Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility,~     dose and source, may have an impact on transfusion responses and outcomes. Because of the~     relative scarcity of PCs the selection of a specific PC for issue to the patient remains a~     challenging process. Regulatory agencies do not fully address these characteristics in their~     recommendations for prophylactic transfusions.~      The aim of the study was to analyse the effect of product-related factors in a real life~     setting, in order to determine which ones are the most relevant when selecting PCs for~     patients in prophylactic conditions. Two different endpoints are studied: the corrected~     count increment and the platelet transfusion time intervals.~   "
13157|NCT02885025|"~     Allergic rhinitis is a common illness suffered among US Veterans. There are medications that~     help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some~     patients have increase symptoms with exposure to their trigger, such as a grasses when~     combined with pollution due to oxidative stress from pollution. In this study, patients with~     allergic rhinitis to grass will be given broccoli sprout extract that contains an~     antioxidant sulforaphane do see if there is beneficial effect in these patients.~   "
13158|NCT02885012|"~     The purpose of this study is to learn more about the safety and effects of switching~     treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24~     weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension~     (CTD-PAH).~   "
13159|NCT02884999|"~     This cohort study describes the epidemiology of trauma patients and their management in a~     French academic trauma center. It also aims to determine what recommendations from the~     European trauma guidelines is applied in routine.~   "
13160|NCT02884986|"~     Acute pain is the result of activating nociceptive pathways in both the peripheral and~     central nervous system. The origin of most acute pain from surgical stimulation is the~     mechanical trauma of the local tissue and the subsequent acute inflammatory response.~      No studies have investigated the combined use of anti-inflammatory analgesics with spinal~     anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in~     patients undergoing day-case IHR. The aim of the investigators study is therefore to assess~     the efficacy of preoperative combined administration of etoricoxib and standard spinal~     anaesthesia in the reduction of postoperative pain following IHR.~   "
13161|NCT02884973|"~     It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of~     live births, 5,000 new cases per year currently in France These are serious diseases that~     can be life-threatening to more or less short term.~      The advances in surgical techniques in recent years has improved the prognosis of these~     patients in the first months of life.~      The success of surgery is, among other things, conditioned by a support per complex~     operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic~     support techniques.~      These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of~     non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.~      The fundamental principle of NIRS based on an estimate of the percentage proportion of~     cerebral oxy-hemoglobin.~      A light source is emitted by NIRS and through body tissues to the brain where the light will~     be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.~      Refracted light will be analyzed by NIRS which in turn using software will help to determine~     a percentage of oxyhemoglobin.~      Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this~     principle to estimate cerebral tissue oxygenation but also for other tissues such as the~     kidney.~      More than the figure, those are changes NIRS compared to a baseline that will alert us to~     the conditions of tissue oxygenation and allow us to identify hypoxia times.~      Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the~     percentage of oxyhemoglobin and deoxyhemoglobin percentage.~   "
13162|NCT02884960|"~     The purpose of this study is to evaluate the safety and effectiveness of Embozene~     Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine~     fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6~     sites. Symptom severity, health-related quality of life, and the appearance of the fibroids~     will be assessed prior to treatment. Patients will then undergo the uterine fibroid~     embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which~     will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months~     and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the~     procedure.~   "
13163|NCT02884947|"~     This aim of this study is to improve the outcomes for patient with gliomas undergoing~     neurosurgery by maximising the extent of resection whilst minimising neurological morbidity.~     This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages~     of the patients' clinical management.~   "
13165|NCT02884921|"~     Dental treatment for children should be done in a calm atmosphere and without pain. Oral~     Propacetamol has been shown to be effective in a variety of postsurgical pain models.~      There are no studies on paracetamol preemptive analgesia effect on the pediatric population~     in the dental setting which compare analgesic effect when administered before Vs after the~     dental treatment.~      The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the~     prevention of postoperative pain in children undergoing dental treatment.~   "
13166|NCT02884908|"~     The primary study objective is to determine the efficacy of pregabalin administered orally~     for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress~     disorder who have selected genotypes at the gamma-amino butyric acid transporter and~     receptor genes. The secondary objective is to assess the safety and tolerability of~     pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress~     disorder who have selected genotypes at the gamma-amino butyric acid transporter and~     receptor genes. The investigators will utilize a large and diverse sample of~     African-Americans that includes both genders and individuals with different types of trauma.~     All participants will receive standardized bi-weekly Brief Behavioral Compliance Enhancement~     Treatment (BBCET).~   "
13167|NCT02884895|"~     Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal~     intubation is usually achieved by a direct laryngoscope.It is an effective method but~     requires experience and skill demanding a long learning time.The use of the Laryngeal Tube~     Suction for fast control of the airway is known for many years. The Intubating Laryngeal~     Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the~     effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by~     unskilled practitioners in anesthetized patients with the head in neutral position (trauma~     model).~   "
13168|NCT02884882|"~     Compare the emotional experience of patients with focal lesions of the basal ganglia by~     ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted~     by neuropsychological and electrophysiological assessments.~   "
13169|NCT02884869|"~     Control the airways by endotracheal intubation is an important part of treatment for a~     trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is~     known for many years. The aim of this study is to examine the effectiveness of the~     Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners.~      The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway~     will be more success and faster compared to the standard way of direct laryngoscope.~   "
13170|NCT02884856|"~     Visual shade matching (VSM) is the most common procedure to select an adequate shade in~     dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical~     (VC) the most popular among the available guides. VSM is a subjective and inconsistent~     process with many observer related variables (e.g. color deficiency, experience, gender and~     eye fatigue) that can influence on the final color appearance. The gender influence on the~     accuracy of VSM is controversial.~      The purpose of this study is to evaluate the VSM performed by female (F) and male (M)~     students, using VC shade guide, testing the null hypothesis that VSM is not influenced by~     gender.~   "
13171|NCT02884843|"~     The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in~     blind and fibreoptic endotracheal intubation.~      The current randomized study is designed to assess the success rate of blind and fibreoptic~     endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and~     Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the~     Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite~     differences in their structural design.~   "
13172|NCT02884830|"~     Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) ,~     resulting in increased end expiratory lung volume and positive end expiratory pressure~     (PEEPi) at the end of a normal expiration.~      Static hyperinflation worsens the work of breathing is increases patient's dyspnea.~      The application of a continuous positive airway pressure (CPAP) has been shown to improve~     static hyperinflation and to decrease the work of breathing.~      Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation.~     The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and~     functional respiratory parameters.~   "
13173|NCT02884817|"~     A commercially available mouth rinse with ethyl lauroyl arginate and essential oils claims~     to have enhanced antimicrobial properties as compared to the traditional essential oil~     products. The aim of the present study was to compare the plaque and gingivitis inhibiting~     effect of the commercial product containing essential oils with ethyl lauroyl arginate with~     one placebo and one negative control in a modified experimental gingivitis model. In three~     groups of healthy volunteers, experimental gingivitis was induced and monitored over 21~     days, simultaneously treated with the commercial test solution, 21.6% hydro-alcohol solution~     and sterile water respectively. The maxillary right quadrant of each individual received~     mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and~     mechanical oral hygiene. Compliance and side effects were monitored at day 7, 14, and 21.~     Plaque and gingivitis scores were obtained at baseline and at day 21.~   "
13174|NCT02884804|"~     At the entry of the delivery room, a standard blood analysis will be performed (Blood count,~     PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the~     center's practices.~      The percentage of the immature platelets is a an additional parameter on the hemogram.~      The clinical assessments (recorded in medical records) and biological values will be used to~     determine if there is a correlation between these data and the occurrence of postpartum~     hemorrhage.~   "
13175|NCT02884791|"~     The primary aim of this study is to examine the effect of acute ingestion of fructose on~     serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with~     metabolic syndrome.~   "
13211|NCT02884323|"~     This is a single centre open label study measuring lower limb physiology in patients with~     venous leg ulcers at the University Hospital of South Manchester.~      Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes~     in microcirculation will be measured at baseline after the gekoTM device is activated.~     Ambulatory venous pressure and venous transit times will be performed whilst the participant~     is standing, sitting and supine~   "
13176|NCT02884778|"~     Title: Evaluation of the last version of the PMD200TM and its NoL index in patients~     undergoing laparotomies with intraoperative epidural analgesia Objectives: Measure NoL Index~     variability after a nociceptive stimulus at various intravenous remifentanil infusion rates.~     To compare the results obtained with the PMD200TM with those gathered in our previous study~     with the PMD100TM under the same clinical conditions.~      Study Design: Prospective observational study Subject Population: Adults scheduled to~     undergo elective abdominal surgery with laparotomy under general anesthesia and epidural~     analgesia Sample Size: 30 patients Study Duration: Starts April 2016 - Ends September 2016~     Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None~     expected~   "
13177|NCT02884765|"~     Prospective data will be collected in approximately 250 patients sustaining BCFx with or~     without any additional fracture(s) of the symphysis. Patients will be followed according to~     the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data~     collection will include fracture details (i.e. classification, mechanism of injury),~     treatment details, functional and patient-reported outcomes, and anticipated or~     procedure-related adverse events (i.e. complications).~   "
13178|NCT02884752|"~     Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide~     between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University~     hospitals in France. This increasing number of cases raises several issues. Are they the~     consequences of better detections and reporting, or are they reflecting any epidemiologic~     changes? For answering these questions, we performed a 10 year (2002-2012) retrospective~     multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter~     species.~   "
13179|NCT02884739|"~     As in the general population, there is a gradual and steady increase in life expectancy of~     patients with schizophrenia. But this increase is at a smaller scale, with a rate of~     premature death that is still 2 to 3 times higher than that found in the general population.~     This excessive early mortality is explained by an overrepresentation of suicide deaths, but~     also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are~     only very few epidemiological data on the mortality of patients with schizophrenia,~     including those aged over 60 years. What are the sociodemographic and clinical~     characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they~     benefit from a somatic follow-up adequate and systematic? What are their levels of social~     independence and of quality of life? the answers these questions and the description of the~     offer of geriatric care and of psychiatric care currently provided by different sectors of~     psychiatry in France is an indispensable prerequisite for any project to improve the quality~     of life, state of health and mortality of older patients with schizophrenia.~   "
13180|NCT02884726|"~     The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in~     subjects with advanced and/or metastatic solid tumors.~   "
13181|NCT02884713|"~     Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy.~     Different second-line therapeutic options are available. However, the success of second-line~     therapy has not been addressed or reported from Saudi Arabia.~      Objectives The primary objective was to evaluate the efficacy of the 10-day course of~     levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H.~     pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to~     treatment, factors associated with eradication of H. pylori and adverse events associated~     with the treatment.~   "
13182|NCT02884700|"~     The study aimed at further describing the epidemiological, clinical, diagnostic and~     prognostic features in legionellosis cases admitted to Grenoble University Hospital during~     the 2006-2011period. The investigators also tested lower respiratory samples collected from~     these patients during their routine medical care, using a number of molecular tools allowing~     determination of the involved Legionella species, the bacterial load, and the presence of~     antibiotic resistant mutants. Our primary goal was to define biological markers that could~     predict severity and outcome of infection in legionellosis cases requiring hospitalization.~   "
13183|NCT02884687|"~     The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville~     (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the~     appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are~     realized on the study period with all concerned actors of the Good Use of antibiotics. An~     interviewing plan and tree interview guidelines were created. All SDI are processed by the~     same person.~   "
13184|NCT02884674|"~     Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and~     robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right~     inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind,~     randomized, placebo-controlled, monocentric study.~   "
13185|NCT02884661|"~     In order to evaluate the implementation for the recommendations about the patient care for~     atrial fibrillation in aged patients, a non-interventional study is performed~     retrospectively by comparing two approach of the focus in Cardiology Department and in~     Geriatric unit.~   "
13186|NCT02884648|"~     The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to~     control ovarian, fallopian, or primary peritoneal cancer that has been found during~     second-look surgery.~   "
13187|NCT02884635|"~     The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics~     and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.~   "
13188|NCT02884622|"~     Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA~     mutations in the CFTR gene, polymorphic variations in disease-modifier genes and~     environmental exposure. The contribution of genetic factors has been extensively~     investigated, whereas the mechanism whereby environmental factors modulate the lung disease~     is unknown. Because these factors can affect the epigenome, investigators hypothesized that~     DNA methylation variations at disease-modifier genes modulate the lung function in CF~     patients.~   "
13189|NCT02884609|"~     The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous~     administration of Paracetamol for patients in palliative care.~   "
13190|NCT02884596|"~     The aim of this study was to evaluate the success of inferior alveolar nerve block (IANB)~     for mandibular molars with irreversible pulpitis in women under treatment with selective~     serotonin reuptake inhibitors (SSRIs).~   "
13191|NCT02884583|"~     Prevalences of food allergies and asthma increased in the population during the last~     decades. These two pathologies, responsible for a real burden, are often associated and are~     to be considered as comorbidities; this aspect is more and more studied in the literature~     and many authors tried to find a link between diets and asthma. The narrow link between~     these two atopic pathologies and the fact that food allergy can come along with respiratory~     symptoms also in patients without history of asthma must be better understood, considered~     into the management of food allergy. The main objective of this study is to study the~     prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral~     food challenge (OFC) in patients older than 5 years. The secondary objective is to study the~     risk factors to develop asthma during a food allergy reaction.~      This historical-prospective single center study , was realized in the Allergy Unit of the~     University Hospital of Montpellier. All the patients having been hospitalized for a positive~     OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was~     established according to the recommended international clinical and physiological criteria.~     Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was~     calculated. The search for risk factors was made by a logistic regression univariate then~     multivariate, completed by a decision tree.~   "
13192|NCT02884570|"~     To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and~     fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.~   "
13193|NCT02884557|"~     Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC).~     These diseases are a public health problem because they concern many patients (1 case in~     1000). IBDs are characterized by dysregulated immune response against luminal antigens~     causing chronic inflammation of the gut in genetically predisposed individuals. Their exact~     cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is~     a liver inflammatory disease of unknown origin that is known to be strongly associated with~     IBD. An important clinical observation highlights the mild symptoms of IBD when associated~     to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is~     associated with a progression of intestinal inflammation.~      Based, on these clinical findings that suggest a protective effect regulator of liver~     inflammation on intestinal inflammation, and on the results obtained by our group in mouse~     models that identified the natural killer T cell (NKT) as essential in control of~     experimental colitis, the project aims to determine, using PCR, if the expression of NKT~     cell markers are increased in the colon of patients with PSC+IBD compared to patients with~     IBD alone or PSC alone.~   "
13194|NCT02884544|"~     The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady~     state (following up to 5 weeks of treatment) in children using an outpatient, single-center,~     open-label, flexible dose-escalation study design.~   "
13195|NCT02884531|"~     The incidence of hip osteoarthritis (OA) is rising in western countries due to an ageing~     population and the epidemic of obesity. Patients with hip OA tend to complain of hip pain~     and stiffness which affect alignment and mobility of the whole body and typically result in~     general musculoskeletal pain and disability. Clinical guidelines recommend a combination of~     exercise therapy, weight loss and education, adjusted to the individuals needs, to be tried~     out before arthroplasty eventually is offered. However, to obtain a satisfactory long-term~     outcome is a challenge as patients may not be motivated to comply with a training program~     including functional strength and mobility training, if not guided by a therapist. Basic~     Body Awareness Therapy (BBAT) may be an alternative training modality with a better~     potential for lasting effects. It is a low-impact movement therapy focusing on alignment of~     the body and quality of movements, implemented in daily life activities. In the BBAT~     learning process by doing, reflecting on and transferring body awareness into daily life~     movements, the investigators hypothesize that the patients will obtain self-efficacy and~     mastering, of importance for continued training on their own. This hypothesis will be~     examined in the present randomized controlled trial, comparing Patient Education combined~     with BBAT and Patient Education alone. The investigators will, accordingly, examine the~     supplementary effects of BBAT for patients with hip OA. They will also explore the~     importance of movement quality as observed by physiotherapist using Body Awareness Rating~     Scale, and how it relates to how patients perceive their movement performance. In the study~     the investigators will particularly address long-term effects of the intervention by~     comparing survival of the native hip in the two groups included in the study. Data from the~     study will be included in a national database of patients with non-surgical treatment of hip~     and knee OA (NOAR), giving rise to comparison of different movement therapies.~   "
13196|NCT02884518|"~     The purpose of this study is to determine whether dopamine synthesis capacity by using [18~     fluorine(F)]-DOPA PET for patients with schizophrenia in the maintenance phase can predict~     treatment discontinuation.~   "
13197|NCT02884505|"~     The overall purpose of this study is to employ a pragmatic, multidimensional assessment of~     hypersomnolence that piggybacks on routine clinical care in patients with suspected~     disorders of central nervous system (CNS) hypersomnia, to determine whether these additional~     objective and subjective assessments are useful in the diagnosis and management of these~     patients.~   "
13198|NCT02884492|"~     This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET~     scan is used to measure the abnormal accumulation of protein called tau in the brain. These~     are thought to be involved in Alzheimer's disease. The investigators will also perform brain~     MRI and to tests to measure the participant's memory and thinking.~   "
13199|NCT02884479|"~     The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with~     Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell~     Lung Cancer.~   "
13200|NCT02884466|"~     Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the~     leading cause of years lived with disability. The high prevalence causes a substantial~     impact on patients, communities and health-care systems. There is a continuing challenge to~     offer evidence-based rehabilitation for patients with CLBP. There is a lack of studies on~     adequate follow-up approaches to maintain successful treatment. No earlier study has~     assessed if the positive treatment effects of a multidisciplinary rehabilitation~     intervention can be maintained with an intervention alternating between inpatient~     interventions and home-based activities.~      Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in~     maintaining successful treatment after 6 months, than a usual multidisciplinary~     rehabilitation intervention in patients with CLBP.~      The novel intervention is a 14-week program alternating between in total three weeks of~     inpatient intervention and home-based activities. This alternation allows the participants~     time and opportunity to adapt and transfer inpatient learning to activities and~     participation in their own environment in interaction with everyday life situations and~     surroundings. Usual care is a four-week inpatient intervention. It is hypothesized that the~     intervention will be superior to usual care.~      Method The study will be conducted at The Danish Rheumatism Associations' rehabilitation~     centre Sano Aarhus. 160 participants with CLBP will be randomly allocated to one of two~     groups. The novel intervention consists of: 1) a pre-admission day, 2) two weeks of~     home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities,~     5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd~     two-days inpatient follow-up. Usual care consists of a four-week inpatient intervention.~      The two groups will be compared according to disability, pain, pain self-efficacy, quality~     of life, depression and exercise capacity.~      Relevance The present study has emerged out of the fields where patients, clinicians and~     researchers intersect and is consequently highly clinically relevant. If positive treatment~     effects can be maintained or even improved in the long term, the results may serve as~     inspiration for the design of multidisciplinary rehabilitation interventions in clinical~     practice; this will be valuable for future patients with CLBP.~   "
13201|NCT02884453|"~     Some cancers of the oesophagus and stomach express excessive copies of either the cMYC~     (Myelocytomatosis oncogene) gene, the HER2 (Human epidermal growth factor receptor 2) gene~     or both. These genes may potentially contribute to the growth and spread of cancer.Ibrutinib~     is a drug that is already used in the treatment of certain cancers of the immune system.~      There is preclinical evidence that it shows activity against gastric and stomach cancer~     cells over-expressing cMYC and HER2 genes.~      The iMYC study will assess the activity of ibrutinib in cancers of the oesophagus and~     stomach which over-express these genes and which have previously been treated with standard~     chemotherapies.~      Any anti-cancer activity seen will be measured and correlated with metabolic changes on FDG~     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) - PET (positron emission tomography)~     scan, changes in DNA and circulating tumour cells in the blood, and molecular changes in the~     cancer itself through the use of optional repeat tumour biopsies. If an effect is seen it~     could provide justification for further research in this group of patients.~      Patients will be eligible if they have advanced cancer of the oesophagus or stomach and have~     been treated with at least one line of prior therapy. The study will be conducted at the~     Royal Marsden Hospital at its Sutton and Chelsea sites.~      It will involve an initial group of up to 17 patients. Screening, recruitment and follow up~     will last for 3 years in total.~      Patients wishing to take part must consent to having their cancer biopsied to test for cMYC~     and HER2 amplification, as well as a number of imaging and blood tests. There are optional~     further tumour biopsies whilst on study.~      Patients will be treated with ibrutinib until progression of their disease or unacceptable~     toxicity.~   "
13202|NCT02884440|"~     Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to~     treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after~     spine surgery with 24 hours morphine consumption~   "
13203|NCT02884427|"~     The design aims to investigate the value of direct current, specifically the polar effects~     this has, and its influence on neuromuscular changes described in the literature. This~     research proposal seeks to assess the influence of application anode and cathode pole in~     muscle strength when testing handgrip dynamometry by healthy subjects. The study will~     evaluate changes in muscle strength when performing a manual dynamometer test in a group~     exposed to the application of cathode, another exposed to the application of anode, compared~     with a control that will not receive the intervention will be evaluated. Subsequently the~     investigators proceed to compare the maximum force obtained from the dynamometry test in~     each of groups and between the groups .~   "
13204|NCT02884414|"~     The purpose of this study is to quantify differences in joint mechanics between different~     types of walking in healthy individuals and individuals with knee pathology. The~     investigators will determine how modifying gait through feedback and/or cutaneous~     stimulation changes joint loading.~   "
13205|NCT02884401|"~     This is a prospective case series study aiming to evaluate the effect of post-menopausal~     osteoporosis on the jaw bone around dental implants with a modified titanium surface. The~     study consists of 8 visits that will be performed within a minimum period of 15 months.~     Participants will be recruited from the Rheumatology Department and Radiology Department at~     Barts Health National Health Service (NHS) Trust.~      Participants will include 20 post-menopausal osteoporotic women with a requirement of a~     tooth to be replaced. The main objective of this study is to radiographically compare~     alveolar (jaw) bone changes in width and height after the placement of a dental implant with~     a hydrophilic (SLActive) surface and 12 months after loading (placement of the crown) it in~     post-menopausal osteoporotic women.~   "
13206|NCT02884388|"~     The purpose of this study is to validate the hypothesis that a combined nerve block produces~     better outcomes including intraoperative stress, hemorrheological indexes, postoperative~     immune function, and incidence of postoperative complications than general anesthesia.~   "
13207|NCT02884375|"~     The management of older patients with cancer has become a major public health concern in~     Western countries because of the aging of the population and steady increase in cancer~     incidence with advancing age. Cancer treatment of aged patients is complex due to~     comorbidities, polypharmacy and functional status. The heterogeneity of the older population~     in terms of comorbidities and functional status may explain the difficulty in establishing~     management recommendations.~      Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can~     evaluate patient's resource and strengths, in order to help oncologist to define the most~     effective treatment. The GA developed by geriatricians and recommended by the International~     Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health~     status; comorbidities; functional status; nutritional, cognitive, psychological, and social~     parameters; and medications. The GA uses validated geriatric scales to produce an inventory~     of problems, which can then serve to develop an individualized geriatric intervention plan;~     it may be an important step in selecting elderly patients for cancer screening and~     treatment.~      The objectives are:~        -  To assess the role of GA for decision making process for older patients with cancer~        -  To identify geriatric and oncologic factors associated with overall survival, treatment~          feasibility, toxicities, morbidities~        -  To develop and/or validate screening tests for frailty in geriatric oncology~        -  To develop and validate frailty classifications~      Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective~     study that includes all patients age 70 years or older who has a diagnosis of solid cancer~     or hematologic malignancies in French hospitals~   "
13208|NCT02884362|"~     In research on melanoma, translational research is the essential link between basic research~     and clinical research by facilitating the passage between discovery and improvement in the~     quality of patients care.That is the reason why it is very important to collect, and~     centralize clinical and biological data of patients with melanoma.~      The aim of the project is to provide to scientific community a structured, mixed clinical~     and biological database, unique in France, in order to insure accessibility to clinical~     data.~   "
13209|NCT02884349|"~     The aim of the study is to determine the influence of the combined anteversion of acetabular~     cup and the femoral stem used in total hip arthroplasty on the theoretical and actual range~     of motion of the hip in three dimensional space.~   "
13210|NCT02884336|"~     Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused~     by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being~     the orange zest and the bacteria is considered harmless.~   "
13212|NCT02884310|"~     Individually-tailored administration of the opioid analgesic component during general~     anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to~     look if the gradient response of a nociception index to a calibrated tetanic stimulus during~     standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal~     intubation and before skin incision. The studied parameters are the SPI index developed by~     General Electric, the Analgesia Nociception Index and the pupil dilation using the pupil~     scan algometer.~   "
13213|NCT02884297|"~     The purpose of this study is to evaluate the feasibility of the measurement of the placental~     perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography with~     a contrast agent: SonoVue®.~   "
13214|NCT02884284|"~     In order to accelerate border crossing between basic research and clinical research in~     breast cancer, it is necessary to easily use clinical and biological data. That is the~     reason why it is very important to create a clinical, biological and pathologic beast cancer~     database, mainly prospective but also retrospective. All data are from patients treated in~     Toulouse Centre.~      The scientific community will easily have access to clinical and biological informations~     through a centralized, structured database , leading to optimize patients with breast cancer~     treatment.~   "
13215|NCT02884271|"~     In the last ten years patient safety during routine surgical interventions has increased;~     however as there is an increase in the number of specialized surgical interventions and high~     risk patients like elderly and emergency patients, the incidence of perioperative cardiac~     arrest has not reduced but remains fixed. The incidence of perioperative cardiac arrest~     varies from 4.3-34.6 for each 10,000 procedures. However as in a lot of other countries~     exact data are lacking also for Turkey. With this study the investigators want to start~     collecting data about intraoperative cardiac arrest in Turkey, starting at their institution~     The aim is to evaluate the incidence and outcome in the study. Secondary aim is to assess~     the causes of cardiac arrest in the operating room.~   "
13216|NCT02884258|"~     This case-control study compares IVF results and live birth rates in women undergoing IVF~     with a history of bariatric surgery as compared to women without bariatric surgery history~     and matched for weight, age and parity.~   "
13217|NCT02884245|"~     E2 given in late luteal phase can be extended beyond the onset of menses for a period of at~     least eight days before the start of the stimulation, allowing scheduling of stimulation in~     order to limit oocytes retrievals during weekends .~      Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended~     release kinetics, seems particularly interesting for a synchronous recruitment of follicles~     after homogenization of the cohort.~      The objective of this study is to evaluate the impact on the response to ovarian stimulation~     with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age~     at which declining of ovarian reserve usually begins. The management of these patients in~     terms of organization of the center is also evaluated.~      The scheduling of IVF cycles represents a double benefit. On one hand, to enable a~     synchronization of the follicular cohort for a best response and a higher number of mature~     oocytes. On the other hand, a more efficient organization for both the center (avoiding~     retrievals on weekends and public holidays, organize and distribute equally the activity,~     reduce cost operations) and couples (personal and professional organization).~   "
13218|NCT02884232|"~     The purpose is to evaluate feasibility of medical supervision of professionally active~     asymptomatic wood workers with questionnaires and nasofibroscopy.~      Secondary purposes are:~        -  Feasibility evaluation of identification of former and actual professional expositions~          to wood dust and to various naso-sinusal carcinogenics in case of co-expositions~          (formaldehyde, chrome, nickel, leather)~        -  Description of abnormal symptoms identified by occupational doctor and needing an~          otorhinolaryngology test~        -  Description of results and examinations induced by nasofibroscopy in symptomatic or~          asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases~        -  Evaluation of participation of workers retiring in 2 years after inclusion to medical~          supervision program~        -  Evaluation of information flow among different players~        -  Assessment of costs induced by this targeted screening: direct medical costs (screened~          pathologies, induced additional examinations…) and indirect costs for company (duration~          of worker absence for transfer, medical and additional examinations).~   "
13219|NCT02884219|"~     Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in~     preterm infants, especially in those born at a gestational age <28 weeks and/or a birth~     weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has~     been associated with serious complications. However, a common finding is that medical and/or~     surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity.~     This might be related to the fact that a substantial portion of preterm infants are treated~     unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without~     any specific intervention. An expectative approach is gaining interest, although convincing~     evidence is still missing.~      The objective of this study is to investigate whether in preterm infants <28 weeks'~     gestation with a PDA an expectative management is not inferior to early treatment with~     regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or~     bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.~   "
13220|NCT02884206|"~     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on~     cognitive function in patients with heart failure with preserved ejection fraction.~     Cognitive function will be assessed using a comprehensive battery of tests with an~     evaluation of longitudinal change of cognitive domains including memory, executive function,~     and attention.~   "
13260|NCT02883686|"~     Depression during pregnancy and postpartum is a major public health problem with adverse~     correlates and consequences for women and their children; although efficacious treatments~     for depression during pregnancy exist, few women receive such care. A widely recognized~     barrier to treatment engagement is the lack of effective, available care that is well~     aligned with women's treatment preferences. To close the gap between treatment need and~     receipt among depressed pregnant women, this study aims to develop and test the~     effectiveness of disseminating behavioral activation, an efficacious and acceptable~     treatment for depression, using peer delivery for pregnant women with depression.~   "
13261|NCT02883673|"~     The purpose of this study is to assess the safety and effectiveness of the InPress Device in~     treating primary postpartum hemorrhage.~   "
13221|NCT02884193|"~     Cryotherapy has a wide range of clinical applications in rehabilitation, used for activities~     such as controlling inflammation, pain control or management of edema after an injury or~     surgery. In the field of cryotherapy they studied cold neuromuscular responses, where it has~     shown a decrease in nerve conduction velocity, which leads to a decrease in muscle strength.~     However it has been described in some work applications brief cold (Quick Icing) may be~     opposite to those described effects, increasing the strength, the time of intervention the~     most important and decisive in these possible improvements or decreases factor. This effect~     is observed in response to a few seconds of application of cold, and would be given by an~     increased activity of motor neurons. Assess the influence of rapid cooling application~     (Technique Quick Icing) and prolonged cooling in handgrip strength when performing a~     manual dynamometer test in college students.~   "
13222|NCT02884180|"~     Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group~     clinical trial~      Trial acronym: DEXRAR~      Background: Effective postoperative pain management is essential for the well-being and~     rehabilitation of the surgical patient. No gold standard exists for pain treatment after~     revision total knee arthroplasty (TKA) and combinations of different medications are used~     with virtually no evidence for combined analgesic efficacy.~      Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone~     as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local~     infiltration analgesia~      Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B)~     isotonic saline i.v.~      Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised~     computer-generated allocation sequence and allocation concealment with block size of 12.~     Blinding of assessor, investigator, caregivers and patients.~      Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for~     the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of~     0,05 and a type 2 error rate of 0,20.~   "
13223|NCT02884167|"~     Constipation is a symptom based disorder with a prevalence of 15% in the adult population~     and its management remains challenging. Although not life threatening, constipation is~     associated with impaired quality of life, increased healthcare costs and excess work~     absenteeism. Constipation represents a heterogeneous disorder with a multifactorial~     pathogenesis. Several risk factors have been suggested to lead to the condition and are~     divided in 3 main categories: a) physiological, b) environmental and c) demographic. To~     date, there is lack of large epidemiological studies on proposed aetiological factors of~     constipation, especially studies assessing all proposed risk factors of constipation~     together.~      The overall aim of this study is to investigate the multidimensional (physiological,~     environmental and demographic) predictors of constipation with the use of a multivariate~     analysis statistical model.~      This is a large single centre case control study comparing constipated adults with healthy~     individuals matched for age, gender and ethnicity.~      The duration of the study is 2 weeks in total and includes a screening visit, a 2 week~     run-in period and a baseline visit at the end of the run-in period. Transit time between~     constipated and healthy individuals is assessed at baseline visit. Differences in~     gastrointestinal symptoms, dietary intake as well as differences in stool output (e.g. stool~     frequency and consistency) between constipated and healthy individuals are assessed over the~     baseline period (the week before the baseline visit). Differences in female sex hormone~     levels as well as stool markers and markers of fermentation (e.g. fecal water, stool pH,~     short chain fatty acids) between constipated and healthy individuals are assessed at~     baseline visit. Furthermore, differences in environmental measures (physical activity,~     anxiety, smoking) and differences in demographic measures (age, gender, body mass index)~     between patients suffering from constipation and healthy individuals are also assessed at~     baseline visit.~   "
13224|NCT02884154|"~     The exact incidence of subepithelial tumors (SETs) in the gastrointestinal (GI) tract is~     unknown, but the prevalence of gastric SETs detected during routine~     esophagogastroduodenoscopy is 0.36%. GI SETs may include leiomyoma, GI stromal tumor (GIST),~     schwannoma, lipoma, cyst, or ectopic pancreas. Surgical resection is the principal~     diagnostic and therapeutic method for SETs, especially for large and symptomatic ones.~     Preoperative pathological diagnosis of SETs may facilitate clinical decision making, but~     conventional endoscopic forceps biopsy does not yield adequate amounts of subepithelial~     tissue for definitive diagnosis.~      Although endoscopic ultrasonography (EUS) is the best imaging modality for the evaluation of~     SETs, it cannot substitute histopathological diagnosis. EUS-guided fine-needle aspiration~     (EUS-FNA) may provide adequate amounts of tissue for the diagnosis of SETs, but it does not~     always afford adequate samples for immunohistochemical analysis because of the often small~     number of cells obtained by aspiration. Since some SETs, especially GI mesenchymal tumors~     such as GIST or schwannoma, have varied morphologic appearances, and diagnosis using a small~     biopsy is not straightforward, immunohistochemical analysis is strongly advisable, if not~     essential. EUS-guided Trucut biopsy (EUS-TNB) may overcome the limitations of EUS-FNA in~     procuring sufficient core tissue specimens. Although EUS-TNB is more accurate than EUS-FNA~     for diagnosing GI mesenchymal tumors, the rigidity of its 19-gauge (G) caliber and the~     mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its~     use for SETs located in the gastric antrum and duodenum. Therefore, a needle facilitating~     adequate histological core sampling with easy maneuverability needs to be established. A 19G~     EUS-guided fine-needle biopsy (EUS-FNB) device with ProCore reverse-bevel technology was~     recently introduced. A multicenter study revealed that histological samples could be~     successfully obtained using this needle in most patients having GI SETs, with a diagnostic~     accuracy of >80%.10 However, because of technical difficulties with this needle in the~     gastric antrum and duodenum, the same FNB device was recently developed in a 20 G platform~     with coiled sheath. This prospective, multicenter study aimed to evaluate feasibility,~     yield, and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath~     in patients with GI SETs.~   "
13225|NCT02884141|"~     ARCADIA is a national registry designed to document phenotypic and genetic traits in~     patients with renal and/or cervical artery fibromuscular dysplasia (FMD).~      FMD is a group of arterial diseases that most commonly involve renal and carotid arteries.~     Patients with FMD may present with renovascular hypertension and/or with cerebrovascular~     symptoms. Angiographic classification includes the multifocal type and the focal type. FMD~     may affect one or more vascular beds and progress to more severe stenosis and to renal or~     cerebrovascular complications. FMD may be familial (OMIM #135580).~      Our main objective is to create a FMD registry that will collect standardized information~     from all consenting patients diagnosed with the condition in 16 participating centers. This~     registry, along with a collection of leukocyte DNA, will constitute a resource for further~     clinical research on FMD. The first application will be the assessment of the frequency of~     multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal~     artery FMD and vice-versa. The second application will be a case-control study to identify~     susceptibility genes for FMD.~      Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with~     either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial~     angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection~     of bioclinical and morphologic information. Phenotypic assessment will be performed in~     accordance with current recommendations and best clinical practice.~      Given the multicenter nature of the study and the recruitment capacity of each centre,~     enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate~     estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95%~     confidence interval will extend 0.035 from the observed proportion for an expected~     proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition~     to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a~     genome-wide association study seeking for susceptibility genes~   "
13226|NCT02884128|"~     This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal~     encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid~     tumors.~   "
13265|NCT02883621|"~     Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip~     of the colonoscope, was proven to increase the adenoma detection rate during screening~     colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization~     and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is~     still under investigations. The aim of this study is to compare the diagnostic yield of the~     CAE to the standard endoscopy in esophagus.~   "
13227|NCT02884115|"~     A continuing challenge to determining the response to treatment of early syphilis (primary,~     secondary, early latent syphilis) is exemplified by the substantial proportion of patients~     who fail to achieve serological cure and remain serofast. Although retreatment is often done~     in clinical practice, optimal management remains uncertain due to the paucity of data~     regarding serological response to retreatment and long-term outcomes. Furthermore, the~     investigators cannot rule out that the gradually increasing seroreversion/serological cure~     rates may have been due to the natural decline in rapid plasma regain (RPR) titers after~     initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the~     investigators would like to conduct a clinical trial to compare the serological response~     rates of serofast early syphilis cases retreated with three doses benzathine penicillin and~     absence of any retreatment (control group).~   "
13228|NCT02884102|"~     Here we propose an integrative sequencing approach utilizing a 1500 gene exome comparative~     analysis between multiple myeloma or related plasma cell malignancies and normal cells~     coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of~     the genetic alterations for the purpose of identifying informative and/or actionable~     mutations in patients with multiple myeloma and plasma cell malignancies. The approach will~     enable the detection of point mutations, insertions/deletions, gene fusions and~     rearrangements, amplifications/deletions, and outlier expressed genes among other classes of~     alterations.~   "
13229|NCT02884089|"~     This study will look at how a single dose of abemaciclib will impact the body's ability to~     get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the~     effect of a single dose of abemaciclib on kidney function by measuring blood and urine~     markers. Side effects will also be documented.~      Each participant will complete four study periods. During each study period, participants~     will stay in the clinical research unit for nine days and eight nights.~      The study will last approximately 10 weeks, not including screening. Screening is required~     within 28 days prior to the start of the study.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
13230|NCT02884076|"~     To validate the ability of the Sodergren score in guiding the management of symptomatic~     haemorrhoids in a Malaysian population.~   "
13231|NCT02884063|"~     In the way for developing and optimizing protocol to be used as non- invasive methodology~     used as routine testing for PGS.~      This protocol is to be adapted to replace the using of life embryo cells for genetic testing~     and aneuploidy study as well as for any type of genetic testing including single gene~     disorder or HLA typing or study.~   "
13232|NCT02884050|"~     Data generated from this pilot project will be used to support a larger, NIH funded study to~     investigate the physiologic mechanisms associated with the cognitive side effects of a~     commonly prescribed antiepileptic drug (AED), topiramate (TPM). This study will provide~     pilot data to 1) demonstrate the viability of using quantitative electroencephalogram (EEG)~     to examining physiological effects of AEDs as they relate to language function, and 2)~     perform formal power estimate calculations in support of a longer-term connectivity study~     using stochastic modeling techniques including power, coherence, and Granger causality~     metrics to analyze AED effects on quantitative EEG. Traditionally, the cognitive side~     effects of AEDs have been considered a byproduct of decreased neuronal excitation associated~     with medical therapy, although recent data suggests that this may not be true for some newer~     medications, such as TPM. The proposed experiments will employ quantitative EEG to~     investigate the effects of topiramate on neuronal network connectivity and~     pharmacokinetic/pharmacogenetic relationships in order to explore individual physiological~     responses. Topiramate is selected because of its relatively unique effects on generative~     verbal fluency, but unlike older AEDs, TPM is associated with little EEG change. The~     investigators will compare the effects of TPM to baseline and an inactive placebo in a~     randomized double blind crossover design.~   "
13233|NCT02884037|"~     In Non-alcoholic fatty (NAFLD) liver disease patients, the investigators hypothesized that~     rifaximin might act on Gram-negative bacteria and IBO thereby inhibiting LPS-mediated~     proinflammatory cytokine production. This work evaluates the efficacy of 6 months~     administration of rifaximin in NAFLD patients.~   "
13234|NCT02884024|"~     An observational study designed to compare colonic cytokine concentrations in lean versus~     obese individuals~   "
13235|NCT02884011|"~     Retrospective study to examine the effects of chronic antihypertensive medications on~     vasopressor dosing in septic shock~   "
13236|NCT02883998|"~     To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal~     outpatient physical therapy (OPT) after hospital discharge of patients undergoing a~     unicompartmental knee arthroplasty (UKA).~   "
13237|NCT02883985|"~     The purpose of this study is to determine whether high dose of radiation therapy (RT) are~     effective over standard 6-week radiation treatment in patients with breast cancer~   "
13238|NCT02883972|"~     This study will investigate whether influenza vaccine uptake by school-age children (in~     school-based clinics) can be increased by making behavioural-insight informed changes to the~     invitation process which encourage parents to return consent forms.~   "
13239|NCT02883959|"~     Pain is a common problem encountered in about 60 % of critically ill patients who can~     communicate. Its occurrence can be related to several causes, mainly dominated by invasive~     procedures.~      Pain management is typically based on a combination of prevention, evaluation, and~     therapeutic agents. However, it appears important to develop adjuvant approaches. Music~     therapy is one of them and that has been evaluated in various medical conditions.~      The aim of our study is to evaluate the analgesic effect of music therapy in critically ill~     patients during potentially painful nursing procedures.~   "
13262|NCT02883660|"~     The purpose of this study is to determine whether patients who have been prescribed~     antidepressant medications and have experienced significant adverse effects are more likely~     to be poor metabolizers on the CYP450 (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+) drug metabolizing~     enzymes and/or homozygous for the short allele of the serotonin transporter (SLC6A4)~     compared to patients who took an antidepressant medication and did not experience~     significant adverse effects but also had minimal or no response to the medication. The~     target medications being studied include escitalopram, citalopram, paroxetine, fluvoxamine,~     venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran only.~   "
13240|NCT02883946|"~     Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases~     of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs,~     cladribine and pentostatin, which have shown similar efficacy and constitute the gold~     standard of care either as front-line therapy or for relapsed patients.~      However, despite the remarkable response rates obtained with purine analogs therapy, some~     patients will eventually relapse and the efficacy of these agents seems to decrease at each~     line of treatment. The addition of new molecules to purine analogs may improve the response~     rates and prevent relapse.~      Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20~     molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years~     ago and several series of patients treated with rituximab as monotherapy were published in~     the following decade, reporting response rates ranging from 25% to 80%.~   "
13241|NCT02883933|"~     The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in~     western populations. Among all melanomas, those located on the head and neck are more~     frequent than expected regarding the surface of this anatomical area, occur in older~     subjects than melanomas at other sites and have a worse prognosis than melanomas at other~     sites. The question whether head and neck melanomas could be a distinct entity has been~     debated.~   "
13242|NCT02883920|"~     Work related asthma and rhinitis are frequent diseases with a significant morbidity and a~     social and economic impact. Farmers are highly exposed to various inhaled agents such as~     organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders~     and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis~     and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop~     farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to~     pollen allergy, especially gramineae pollen. They can also be related to the use of~     pesticides or exposure to mites .~   "
13243|NCT02883907|"~     The utility of conventional imaging in the development of new treatments for osteoarthritis~     (OA) is hindered by:~        1. Difficulty in non-invasively evaluating the initial response to potential new treatment~          options. OA typically develops over a long time period, so evaluating the efficacy of~          new treatment options over a timeframe relevant to experimental medicine studies is~          difficult.~        2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous~          condition and identifying which subgroups of patients are most likely to benefit from~          new treatments is crucial.~      Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential~     to solve these problems. However, their reliability needs to be fully established and~     knowledge of likely effect sizes is required to inform sample size considerations for~     further longitudinal/interventional studies.~      This study aims to help address these issues by:~        1. Calculating effect sizes for MR measurements to inform sample size calculations for~          future studies.~        2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee~          joint.~      The investigators will examine a single knee of an initial 15 participants with MR.~     Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with~     clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex~     and body mass index in a 1:2 ratio) who do not have clinical features of OA.~      Participants will undergo an initial (baseline) MR examination, followed by repeat MR~     examinations at approximately 1 month and 1 year following the baseline examination.~      This will allow us to assess both the reliability of our MR measurements and the expected~     progression in our MR measurements in OA subjects in the absence of any disease-modifying~     intervention.~   "
13244|NCT02883894|"~     Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin~     in European countries, including France.~      Immunologically, BP is characterized by the production of autoantibodies directed against~     two major components of the hemidesmosome, BP180 and BP230.~      The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its~     serum level at diagnosis have been correlated with disease activity. The anti-BP230~     autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis~     did not correlate with disease activity.~      Up to now, no clinical or immunologic factors have been identified to predict outcome of~     patients with good or poor prognosis bullous pemphigoid as defined by long complete~     remission off therapy and recurrent disease requiring maintenance therapy for years. The~     usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also~     remains unclear.~   "
13245|NCT02883881|"~     determination if, within a keratoconic population, strong eye rubbing was correlated with~     visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry,~     keratometry, and tomography classification determinating keratoconus stage.~   "
13246|NCT02883868|"~     To assess the association between stromal demarcation line after collagen crosslinking (CXL)~     for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical~     outcomes of CXL~   "
13247|NCT02883855|"~     The aim of this study to determinate if there is a correlation between visual acuity gain in~     patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK)~     corneal keratoplasty and the central thickness of the graft.~   "
13248|NCT02883842|"~     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to~     evaluate the effectiveness of automated mobile phone text message-based intervention for~     secondary prevention, including lifestyles modification, medication adherence improvement~     and risk factors control among coronary heart disease (CHD) patients with diabetes. The~     participants will be randomized into intervention and control groups in a 1:1 ratio. The~     intervention group will receive 6 pre-designed text messages per week in addition to usual~     care for one year, while the control group will receive usual care.~   "
13258|NCT02883712|"~     Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic~     drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as~     exemplified by some genetic diseases. However, the lack of specific guidelines for the~     choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the~     very large number of drugs with different and sometimes complex metabolism are challenges~     for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to~     pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage~     and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more~     unrelated with the cytochrome P450 and less generalised adverse events. However, their~     metabolism could be more complexe (i.e. the less known Uridine~     5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological~     adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which~     could largely impede the observance and the quality of life even if the number of seizure is~     reduced or not. The goal is to determine the predictive and the modulating factors of~     pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with~     a specific analysis (drug by drug) from a cohort of 1000 patients.~   "
13249|NCT02883829|"~     Adolescence and emerging adulthood are critical periods during which health outcomes may be~     imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in~     the college environment, college students with T1D may be especially vulnerable to these~     risks.~      Our goal is to develop preliminary evidence in support of a scalable intervention targeting~     diabetes health management and alcohol use avoidance for college youth with T1D. For this~     project the investigators will engage at least 120 youth with T1D in college. The study~     sample will be drawn from two national, non-profit, peer support based groups: the College~     Diabetes Network (CDN) and the TuDiabetes Network.~      The study aims to 1) develop and pilot and educational video intervention; 2) determine the~     acceptability and efficiency of various web platforms for engaging college students in~     completing a survey about their health and alcohol use and to; 3) compare effectiveness of~     delivery of a brief intervention delivered by a peer versus a provider. The investigators~     plan to engage 120 college youth with T1D in completing a survey about their health~     knowledge and alcohol use behaviors.~      Baseline survey items will ask participants about knowledge, attitudes, and practices/plans~     for diabetes self-management and alcohol use in college. In response to survey items,~     participants will provide information on topics including general and disease-specific~     health information, as well as attitudes, behavior, beliefs, and knowledge related to~     alcohol use. Participants will also respond to questions relating to social support, mental~     health, and perseverance and commitment to long term goals.~      Following the baseline survey, participants will be presented with a brief educational video~     about diabetes self-management and alcohol use risks. Participants will be randomized to~     receive one of two educational video interventions. One version will be framed and delivered~     from a peer-based source and the other from a provider, content will otherwise be identical.~     Participants will receive 2 follow-up surveys; one immediately following viewing the video~     and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey~     will test salience, recall, and effects on health knowledge, beliefs and behavioral~     intentions.~      While the main purpose of the pilot is to ascertain preferences in the absence of~     preliminary data, our a priori hypothesis is that peer delivery will have greater impact for~     this population.~   "
13250|NCT02883816|"~     The main objective of this study is to show that there is a concordance between lung disease~     at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis~     asymptomatically.~      This will identify at the first examination at 8 weeks, newborns who have the most impaired~     lung function at 13 months. To meet this objective an assessment of their lung function at 9~     weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.~   "
13251|NCT02883803|"~     The purpose is to determine the effect of mesenchymal stem cells administered at the early~     phase of septic shock on the evolution of organ failure assessed by SOFA score (Sepsis Organ~     Failure Assessment score) on day 7 (or death day or day of recovery unit exit if before day~     7) compared to that observed in a group of control patients.~      The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the~     occurrence and duration of failure of each organ and on the mortality at day 28 and day 90.~     The safety of administration will be also assessed.~   "
13252|NCT02883790|"~     The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin~     1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood~     alteration in cancer patients~   "
13253|NCT02883777|"~     This study is a randomized clinical trial, which will follow and evaluate 120 kidney~     transplant recipients over one year. There will be two groups: a control group and the~     intervention group. The dietitian visits will happen monthly during the first six months and~     twice in the last six months.The intervention group will receive a high-protein and low~     glycemic index diet (1,3g/kg/day of protein) and the control group will keep following the~     hospital standard protocol. The study assessments (weight, anthropometry and biochemistry)~     will be performed during these visits over one year after the randomization period.~   "
13254|NCT02883764|"~     Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics~     screening program are being offered an opportunity to have their blood fatty acids levels,~     especially omega-3 fatty acids [omega-3 index] measured at no charge. At some locations,~     participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three~     months later, all employees at these locations are given a second opportunity to have their~     blood omega-3 levels [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] measured.~     The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study~     population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after~     people have learned their omega-3 index, and 3) determine if differences in omega-3 index~     concentrations can be detected 3 months later between locations receiving information alone~     vs information+coupon.~   "
13255|NCT02883751|"~     Diabetes mellitus is a major public health problem and it is estimated that 300 million~     individuals will be affected by the year 2030. Non-diabetic ulcers are one of the most~     frequent complications of this disease and, if untreated, can lead to the amputation of~     lower limbs. Thus, there has been growing interest in the use of light emitting diode (LED)~     devices to accelerate the tissue repair process and lower the cost of ulcer treatment in~     this population. The Mandaqui hospital complex is a general, tertiary, teaching hospital~     that is a reference center for revascularization surgery and endovascular treatment in~     Brazil. The aim of the proposed study is to evaluate the action of LED therapy on the~     complete healing of ulcers following minor amputations in patients with Diabetes mellitus.~     Methods: A single-center, randomized, controlled, double-blind, clinical trial with two~     parallel groups will be conducted following the criteria of the CONSORT Statement. The~     project will be registered with www.clinicaltrials.gov. The sample will be composed of 40~     patients with a diagnosis of Diabetes mellitus in follow up at the vascular clinic of~     Mandaqui hospital complex who meet the inclusion criteria. The control group (n = 20) will~     receive traditional rayon bandages with essential fatty acids and secondary coverage with~     gauze, which will be changed on a weekly basis. The treatment group (n = 20) will be~     submitted to LED therapy (635 nm; 4 J/cm2; 10 minutes) with weekly applications and the~     ulcers will also receive the traditional bandage treatment described above. The patients~     will be followed up until the complete closure of the ulcer, which will be the primary~     outcome. The ulcers will be examined on a weekly basis by a researcher with no awareness~     regarding the allocation of the individuals to the different groups and will assess, signs~     of infection, edema, redness, heat and the presence of gangrene. Photographs of the ulcers~     will also be taken for the subsequent determination of the area. Another researcher with no~     knowledge regarding the allocation of the participants will measure the surface of the~     ulcers with the aid of the ImageJ software program. The data will be submitted to~     appropriate statistical analyses. After closure of the ulcers, the patients will be followed~     up for a period of six months.~   "
13256|NCT02883738|"~     The main objective of this study is to identify the superficial muscle groups involved in~     gene-related tremor and assess the reduction in the intensity of the tremor after transient~     electrical stimulation.~   "
13257|NCT02883725|"~     The esophageal atresia is a group of birth defects including a break in continuity of the~     esophagus with or without persistent communication with the trachea (tracheoesophageal~     fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive~     ...).~      The current prognosis for this ailment is good. However he persists a mortality (<10%) and~     significant morbidity, firstly related malformations (heart, kidney, for example), and~     secondly with particularly difficult anatomical forms (Forms long defect) .~      The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an~     estimated ± 2,500 new cases over to 10 years in France.~      The current project aims to set up a national registry (Metropolitan France and Dom Tom) to~     measure the prevalence of esophageal atresia among live births, phenotypic characteristics,~     the circumstances of their diagnosis, and their initial future at short-term during the~     first year of life, at which time occurs the vast majority of deaths and complications in~     this disease.~   "
13266|NCT02883608|"~     Examination of major duodenal papilla (MDP) using a standard forward-viewing~     esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the~     modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses~     a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve~     visualization and examination of MDP. The aim of this study is to compare CA-EGD to~     side*viewing duodenoscope for complete examination of MDP.~   "
13267|NCT02883595|"~     The purpose of this study is to determine whether thymosin alpha 1 is effective on improving~     monocyte function and has the desired pharmacologic activity for sepsis~   "
13268|NCT02883582|"~     The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen~     generator with nebulizer in an adjuvant therapy for patients with severe asthma.~   "
13269|NCT02883569|"~     Purpose: Comparative effectiveness research (CER) between surgical and non-surgical~     treatment for patients with low back pain Hypothesis: There will be significant differences~     in surgical and non-surgical treatment effect in patients who need operation for herniated~     intervertebral disc and spinal stenosis.~   "
13270|NCT02883556|"~     The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient~     with locally advanced or metastatic squamous cell carcinoma of the skin~   "
13271|NCT02883543|"~     Eligible patients are administered with oral icotinib 125mg three times daily for two~     months, in which responsive patients (partial response and stable disease) are randomized~     (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent~     radiotherapy, or icotinib monotherapy.~   "
13272|NCT02883530|"~     The Investigators hypothesise that asthma is not a single disease, but a syndrome resulting~     from several distinct underlying disease processes known as endotypes. There are~     approximately 30,000 genes in humans, and each gene is responsible for the production of a~     particular protein. Using a technique called whole genome expression profiling The~     Investigators have undertaken a small study looking at the activity of all 30,000 genes in~     the airway tissue of people with asthma. This work has identified 3 mutually exclusive~     distinct molecular patterns (endotypes) of severe asthma and has identified other~     potentially important molecular targets (manuscripts in preparation). In particular,the~     Investigators have found that 25-50% of patients have asthma associated with the activity of~     proteins called Th2 cytokines (Th2-high asthma). New treatments are in development that~     target this pathway. However, the Investigators do not know what is driving severe asthma in~     patients who do not express these Th2 cytokines. The aim of this study is to investigate in~     more detail the molecular mechanisms driving severe asthma in patients who do not express~     Th2 cytokines (Th2-low asthma), so that the Investigators can identify new targets for~     treatment in this group. To do this the Investigators will collect airway tissue via a~     telescope (bronchoscope), and analyse gene and protein expression in the tissue. The~     Investigators will then compare the molecular activity between patients with Th2-high and~     Th2-low asthma, and healthy control subjects (data obtained from a parallel study).~   "
13273|NCT02883517|"~     To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially~     aggressive primary cutaneous lymphomas, the investigator opted to search a representative~     tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis~     fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary~     cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will~     be collected during 12 months.~   "
13274|NCT02883504|"~     The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main~     goal for performing an echocardiography in the routine clinical practice. Conflicting~     evidence exists about mitral E/e' ratio reliability for predicting high LVeDP~   "
13275|NCT02883491|"~     The overall goal of this clinical research study is to prospectively assess primary outcomes~     related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30~     days. The secondary goal is to compare validated prediction models and a modified European~     Society of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD)~     driven with clinical risk assessment being secondary, and with primary outcomes of clinical~     deterioration within 5 days.~   "
13276|NCT02883478|"~     Compare different corneal parameters and visual outcome of corneal collagen cross-linking~     (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with~     hydroxypropyl methylcellulose.~   "
13277|NCT02883465|"~     Extubation is a crucial step when patients are being weaned from mechanical ventilator~     support. Indeed, the patient has to face an increasing burden imposed to the ventilation~     system. The ability to overcome this event will determine the patient survival. A warning~     signal could be very useful is this situation. 2 recent studies have shown that measuring~     diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a~     population with a high risk of diaphragmatic weakness, characterized by a high failure~     extubation rate. This study aims to verify that this kind of group of patients does exist.~   "
13278|NCT02883452|"~     A new subcutaneous infliximab formulation is being developed by Celltrion, Inc. as an~     alternative to the intravenous regimen where subcutaneous infliximab injection typically~     takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab~     would increase the treatment options available to patients, particularly those wishing to~     self-administer their therapy [Jackisch et al. 2014]. This Phase 1 randomized, open-label,~     multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and~     safety between CT-P13 SC and CT-P13 IV in patients with active CD or active UC.~   "
13279|NCT02883439|"~     The aim of this study is to investigate and to compare the bioavailability of MP29-02 and~     fluticasone propionate in nasal tissue after nasal application. This may provide a rational~     basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has~     demonstrated the efficacy of the twice-daily treatment; however, so far, no data are~     available on the local tissue concentrations of MP29-02 after topical application.~   "
13280|NCT02883426|"~     This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live~     attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.~   "
14034|NCT02873598|"~     This is a dose escalation trial to evaluate the safety of stereotactic body radiotherapy~     (SBRT) delivered in 3 fractions for patients with locally advanced pancreatic cancer (LAPC)~     who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel).~   "
13281|NCT02883413|"~     The purpose of the current study is to investigate the role of Cognitive Remediation Therapy~     (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia~     Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment~     engagement post-discharge, increased rate of weight gain post-discharge, reduction in~     symptom accommodation, and increased behavioral flexibility in adolescents and parents.~   "
13282|NCT02883400|"~     To study spironolactone to prevent CNI kidney injury.~   "
13283|NCT02883387|"~     This study will Investigate whether or not preoperative computed tomography (CT) angiography~     will lower operative times and post operative complications for breast reconstruction~     performed with a deep inferior epigastric artery perforator flap (DIEP).~   "
13284|NCT02883374|"~     The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced~     cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced~     cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then~     overall survival, event-free survival are accessed for efficiency, and laboratory tests~     about the function of vital organs are accessed for safety.~   "
13285|NCT02883361|"~     The proposed research is a randomized controlled investigation of the efficacy of~     motivational interviewing (MI) to improve adherence to aromatase inhibitors (AI) in a~     community sample of patients with poor adherence to AIs.~   "
13286|NCT02883348|"~     Investigating the predictive value of patient satisfaction with care on 6 months and 1-year~     quality of life.~   "
13287|NCT02883335|"~     The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring~     in Lorraine a French region, and follow up on them for an indefinite duration, registering~     disease evolution and intercurrent events.~   "
13288|NCT02883322|"~     Objectives: To identify the respective contributions of back-translations and of the expert~     committee in the process of cultural adaptation of patient reported outcome with an~     experimental design in the adaptation process :~      Four translations of a questionnaire will be produced:~        -  A simple translation by two translators, who serves as the basis for the three other~          translations~        -  A translation made with the use of a back-translation.~        -  A translation with review by an expert committee.~        -  A translation the use of a back-translation and review by an expert committee.~      Properties of each translation will be analyzed and compared~   "
13289|NCT02883309|"~     The patient subjected to hemodialysis has a low physical capacity due to being advanced in~     years and the complexity of the process, which is encouraged by family members and~     caregivers who lead them to a total dependence. The Intradialytic physical exercise is~     presented as an alternative to counteract this functional deterioration of patients with~     terminal chronic kidney failure.~   "
13290|NCT02883296|"~     Main purposes of this study are :~        -  Analysis of relapse risk of anal fistulae with prospective follow-up of patients~          undergoing pelvic MRI every 6 months for one year. This monitoring also determines if~          the presence of path of fistulae visible on MRI during inclusion visit is associated to~          increased risk of perianal abscess under infliximab or adalimumab treatment.~        -  Evaluation of interest of new magnetic resonance imaging sequences for detection of~          persistent anal fistulae under infliximab or adalimumab treatment.~      Secondary purposes are:~        -  Description of patients with one or more paths of fistulae visible with MRI after at~          least one year of treatment with infliximab or adalimumab administered for anal~          fistulae and showing a complete healing of fistulae at clinical examination of~          inclusion visit.~        -  Identification of predictive factors (included the presence of paths of fistulae~          visible with MRI during inclusion visit) of relapse of anal fistulae during the~          1-year-follow-up after inclusion visit.~   "
13291|NCT02883283|"~     This study explores the potential for a more rapid onset of pain relief when drug~     administration is performed through the epidural needle, a technique of epidural loading~     that provides a rapid and reliable level of labor analgesia without the disadvantages of a~     combined spinal-epidural, and could add a valuable new tool to anesthesiologists.~   "
13292|NCT02883270|"~     This study investigates the effects of Robotic-assisted gait training in non-ambulatory~     patients after Guillain-Barré syndrome.The participants are randomly divided into two~     groups.Patients of the treatment group receive robotic-assisted gait training,while the~     contorls receive conventional rehabilitation.~   "
13293|NCT02883257|"~     The purpose of this study is to locate clinical markers (for example, interviews,~     questionnaires, and computer tasks) and biological markers (for example, physiological,~     blood-based, or electroencephalography measurements) that predict response to cognitive~     behavioral therapy for depression.~   "
13294|NCT02883244|"~     The aim of this study is to evaluate the efficacy of a new interdental cleaning device~     (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can~     promote the establishment of a hygienic routine of cleaning interproximal spaces.~   "
13295|NCT02883231|"~     To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and~     to explore its clinical significance.~   "
13296|NCT02883218|"~     The purpose of this study is to understand the impact community-acquired sepsis~     patients'immunosuppression in early stage to prognosis,including mortality and chance of~     secondary infection.~   "
13297|NCT02883205|"~     The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left~     ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing~     life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still~     diagnosed late. This delay in diagnosis is due to the non-specificity of clinical,~     electrocardiographic and echocardiographic disease, but also by a certain ignorance of this~     pathology in the medical community. The importance of early diagnosis of Fabry disease and~     heart disease is well established: enzyme replacement therapy is most effective when~     instituted early, before the onset of irreversible damage such as fibrosis. With the~     blotter, we now have a simple and robust screening tool for Fabry disease, achievable~     consultation. Targeted educational interventions to physicians have shown their~     effectiveness in improving the screening and diagnosis of rare diseases. We offer a~     prospective observational type before / after study, which aims to assess the value of an~     educational brochure for cardiologists to improve the screening and diagnosis of Fabry~     disease in Normandy.~   "
13298|NCT02883192|"~     Cesarean section is a frequent procedure in the obstetric surgery. The most widely used~     anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal~     anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population.~     The aim of the study is to investigate the effect of the preventive use of Ondansetron on~     the prevention of hypotension~   "
13299|NCT02883179|"~     The aim of our study is to compare the analgesic effect of topical application of~     lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal~     tears.~   "
13300|NCT02883166|"~     Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly~     blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of~     abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor~     bio-availability and is fully converted to the active moiety abiraterone. Abiraterone~     acetate tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in~     combination with 10mg prednisolon daily.~      Abiraterone acetate has a low solubility in aqueous media and a low permeability. The~     bioavailability of abiraterone acetate is significantly influenced when ingested with food.~     Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a~     5- or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect~     studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A~     continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more~     compatible with a normal lifestyle and therefore easily sustainable in daily practice.~     However, the effect of a continental breakfast on the absorption of abiraterone is unknown~     yet. Furthermore, increasing healthcare costs are a growing concern in all developed~     countries. Therefore effort should be invested to keep anticancer treatment affordable. A~     food intervention resulting in a better absorption and enhanced exposure to abiraterone, can~     lead to a reduced dose, which could significantly impact health care costs for a tumor which~     is as prevalent as metastatic prostate cancer.~      Therefore the investigators want to perform a bioequivalent study to investigate what dose~     of abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted~     conditions.~   "
13301|NCT02883153|"~     Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is~     expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT~     (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of~     patients with RCC. The aim of the present study is to show the impact of the~     Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.~   "
13302|NCT02883140|"~     Non tumor salivary gland diseases are common and include sialadenitis, sialadenosis, stones,~     stricture and ductal dilatation, anatomical abnormalities. A radiological examination is~     required in order to sign the diagnosis, locate precisely the lesions and define the~     therapeutic strategy. Cone beam computerized tomography (CBCT), because of its accessibility~     and the possibilities it offers in terms of image processing, is a potential alternative to~     the conventional sialography and to the MRI sialography, considered as a gold standard~     procedure. Our comparative study, aims to evaluate the diagnostic performance of the 3D-CBCT~     sialography compared to MRI sialography, in patients with non tumor ductal salivary~     diseases.~   "
13303|NCT02883127|"~     The primary goal of this case control study is to investigate the effect of implementation~     of motivational interviewing with focus on diet and weight gain in addition to the routine~     treatment on prevention of excessive gestational weight gain and fetal growth in pregnant~     women with type 2 diabetes.~      Design: Prospective cohort study where an unselected cohort of all pregnant women with type~     2 diabetes are offered intervention with motivational interviewing in addition to routine~     treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated~     with routine treatment only will be studied. With an inclusion period of 2 years, each~     cohort is expected to include 150 participants. The women in the study group will receive~     one-to-one coaching based on the principles of motivational interviewing, every second week~     throughout the pregnancy. Both cohorts receive the same routine care for pregnant women with~     type 2 diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal~     gestational weight gain and the infants Large for Gestational Age.~   "
13304|NCT02883114|"~     This study is to evaluate the effect of multiple doses of itraconazole, the potent~     cytochrome P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following~     a single dose administration in healthy subject.~   "
13305|NCT02883101|"~     Number of Patients:~      Study group - Bronchiectasis that is not attributable to Cystic fibrosis~        -  Group 1 - Pulmonary Rehabilitation~        -  Group 2 - Standard care~      Sample size - 20 in each arm~      Study Design:~        -  Randomised controlled trial (RCT)~      All patients who qualify for the study will undergo a detailed evaluation. Baseline~     assessment will include the following parameters:~        -  Anthropometry~        -  Pulmonary Function Tests and Respiratory muscle strength~        -  Cardiopulmonary Exercise Testing (CPET)~        -  Six Minute Walk Test (6MWT)~        -  Severity of dyspnoea (Dyspnoea scale)~        -  Limb muscle strength~        -  Inflammatory markers in the serum - C-reactive protein~        -  Quality of Life~      Patients will then be randomized (using table of random numbers) to either the pulmonary~     rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation,~     patients will again be reassessed by the aforementioned tools.~   "
13306|NCT02883088|"~     The multicenter observational CLIMA registry has been conceived to explore correlation~     between OCT morphology of atherosclerotic plaques located in the left anterior descending~     artery with mid and long term clinical outcome.~   "
13307|NCT02883075|"~     Multiple studies have compared spinal anesthetic performed supine versus lateral, with~     varying results, in parturients having elective cesarean section. Needle positioning during~     spinal placement has also been examined. No positioning techniques have demonstrated~     definitive superiority for hemodynamic stability.~      Investigators propose that following spinal placement in the sitting position if the patient~     is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic~     changes caused by sympathectomy related to the subarachnoid block can be avoided.~      This is the first study to examining the influence of position changes after spinal~     anesthetic placement in the sitting position, which includes hemodynamic variables not~     previously studied including cardiac output, (total peripheral resistance) TPR, TSF, and~     pulse pressure variation (PPV).~   "
13308|NCT02883062|"~     This randomized phase II trial studies how well carboplatin and paclitaxel with or without~     atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III~     triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor~     growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
13309|NCT02883049|"~     This randomized phase III trial studies how well combination chemotherapy works in treating~     young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come~     back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase~     inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving more than one drug (combination~     chemotherapy) and giving the drugs in different doses and in different combinations may kill~     more cancer cells.~   "
13310|NCT02883036|"~     Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL~     fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the~     formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on~     chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its~     downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive~     inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML.~     As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and~     nilotinib have more potent anti-leukemic activity and less side-effect. However, acquired~     resistance to TKIs is one of the main obstacles to effective CML treatment and is involved~     in gene amplication of ABL tyrosine kinase point mutations. The outcomes of patients with~     these ABL tyrosine kinase point mutations have linked to worse prognosis and higher~     mortality generally. Metabolic adaptations are common in cancer cells, and cancer cells~     become more dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum~     antibiotics, inhibits mitochondrial biogenesis as its an interesting side-effect.In recent~     study,researchers indicated that tigecycline can eradicate cancer stem cells by targeting~     mitochondrial.Here, the investigators test tigecycline's anti-leukemic activity to chronic~     myeloid leukemia in vitro.~   "
13311|NCT02883023|"~     Capillary malformations (port-wine stains) consist of abnormally developed capillary blood~     vessels in the skin. To date, laser therapy is the only widely accepted treatment modality~     for capillary malformations, but this therapy has a suboptimal effect in approximately~     50-60% of patients.~      Intralesional bleomycin injections (sclerotherapy) are a common effective treatment option~     for vascular malformations with blood vessels with larger diameters. However, bleomycin~     cannot be injected adequately in the small sized vessels of capillary malformations. The use~     of an electric field over the tissue (electroporation) may solve this problem: it increases~     cell membrane permeability and therefore promotes localized delivery of drugs, within~     (endothelial) cells.~      Electroporation in combination with bleomycin sclerotherapy ('electrosclerotherapy') may~     therefore offer new therapeutic options for capillary malformations. This proof of principle~     study aims to explore the effectiveness, safety and feasibility of this potential treatment~     option in a within-patient-controlled pilot study.~   "
13312|NCT02883010|"~     Surgical Site Complications (SSC's) are responsible for increased morbidity in patients~     undergoing surgery resulting in prolonged length of stay in the hospital while increasing~     treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on~     closed incisions has been reported in the literature to reduce SSC's including Surgical Site~     Infections (SSI's), with many promising studies in general surgery, including some studies~     using single use NPWT. However, to date, there are very few randomised controlled trials~     (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may~     be discharged from hospital earlier, with the negative pressure incision management in~     place. This has implications in terms of cost savings for the health care system and enables~     the patient to be able to return to their normal daily routine more quickly. The hypothesis~     of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up~     period, as compared to standard care in patients undergoing colorectal procedures.~   "
13313|NCT02882997|"~     This study will determine the feasibility of using an interactive computer game to elicit~     repetitive practice of paretic arm movements in the homes of community dwelling stroke~     survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.~   "
13314|NCT02882984|"~     A multi-center phase III randomized controlled study to evaluate the efficacy of~     Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from~     non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI~     concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS~     (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive~     function, quality of life (QoL) and adverse events.~   "
13315|NCT02882971|"~     Currently, there is no observational pain scale for use in the outpatient setting for adult~     patients. An observational pain scale can allow for objective measurement of pain in~     patients over time and after treatment without the bias associated with self-report.~     Currently chronic pain patients are asked to rate their pain many times throughout their~     care, often over years. This introduces a bias in reporting as a pain a person is currently~     experiencing will seem more severe then a remembered pain event. A behavioral pain scale~     would allow for an objective measurement of pain that is reliable across multiple raters and~     comparable over time, which can help in judging the success of pain treatments.~   "
13316|NCT02882958|"~     The investigators hypothesize software-based fusion/navigation will be accurate to within 3~     mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of~     prostate US/MRI software-based fusion/navigation technology.~   "
13317|NCT02882945|"~     To explore the possible implications of HLA-DRB1*04 alleles in patients with type 2 DM and~     macroangiopathy~   "
15276|NCT02857335|"~     15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased~     intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish~     whether there was any affect of the disease on their cognitive function~   "
13319|NCT02882919|"~     Health risk screening in adolescent primary care is infrequently performed and results are~     rarely followed by targeted intervention. In response to the need for screening-linked~     interventions, the study team has developed and optimized a web-based, electronic~     Personalized Motivational Feedback tool referred to as Check Yourself v2.0 Based on~     motivational interviewing, a technique to mobilize personal change, Check Yourself is~     designed to promote healthy choices for the multiple behaviors relevant to adolescents.~   "
13320|NCT02882906|"~     One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized,~     hyperirritable points in the skeletal muscles that are associated with palpable nodules in~     muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the~     same clinical characteristics as active MTrPs but they do not provoke spontaneous pain.~     Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic~     neck and shoulder pain.~   "
13321|NCT02882893|"~     The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of~     Crows Feet Lines(CFL).~   "
13322|NCT02882880|"~     To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep~     bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.~   "
13323|NCT02882867|"~     It is well known that participation in sports activities as a youth has several health~     benefits, but at the same time, studies report that the risk is high to obtain injuries~     related to participation. There is, however, increasing evidence that many of these injuries~     can be prevented if necessary measures are taken. Prospective studies are therefore needed~     to be able to plan and carry out measures to prevent the occurrence of injuries. The overall~     aim of the project KLUB is to study the prevalence and incidence of injuries among athletics~     youths aged 12-15 years. A particular focus will be placed on identifying factors associated~     with injury occurrence.~   "
13324|NCT02882854|"~     Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post~     Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of~     post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea~     scores will be assessed with two groups. One group will receive 1 mg of GF to take orally~     and the other group will receive a similar appearing placebo (containing no drug) to take~     orally.~   "
13325|NCT02882841|"~     The study is a multicenter, international descriptive study with a bio-collection in 300~     evaluable Crohn's disease patients to be processed after usual biological tests via~     bioinformatics tools.~      At this time, this study has no impact neither on treatment nor on disease diagnostic, these~     will be based on usual medical practices and is no investigational product associated with~     the conduct of this study.~   "
13326|NCT02882828|"~     Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of~     immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood~     samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert~     system and made them available to the transplant community through our very successful ISBA~     (Immunosuppressive drugs Bayesian dose Adjustment) website.~      Briefly, we first need to develop a population pharmacokinetic model using rich~     pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The~     model developed can then be used for inference of ISD PK parameters in new patients using~     Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK~     parameters are estimated based on the known PK parameters in the population (mean and~     distribution), given the dose and concentrations observed in a patient. Our previous studies~     have shown that a limited sampling strategy (LSS) based on 3 samples collected within the~     first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the~     present study, the AUC0-24h and the recommended dose will be calculated using Bayesian~     estimators previously developed using PK data from the clinical trials run by Veloxis, and~     proposed to the clinicians via a dedicated website comparable with ISBA.~   "
13327|NCT02882815|"~     The purpose of the study is to collect more data about performance and safety of the device~     called IrisFITTM PFO occluder. This data will be used to help more patients who will~     accept treatment with this device in the future.~      Patients will undergo routine examination, procedure and follow-up. Related data will be~     collected and kept in a way that patient info is well protected.~   "
13328|NCT02882802|"~     Research has consistently shown that Veterans with PTSD are more likely to experience higher~     levels of anger and commit aggressive acts compared to Veterans without PTSD. Given the~     significant negative impact that anger and aggression can have on the lives of Veterans,~     their families, and society at large, there is a great need to examine novel interventions~     that could decrease anger and aggression risk with this population. Mindfulness may be one~     such technique, given its effectiveness in assisting individuals in regulating difficult~     emotions and in decreasing physiological reactivity, which have both been implicated in PTSD~     and aggression perpetration. Findings showing that a mindfulness intervention is effective~     in reducing anger and aggressive behavior would be relevant for Veterans with PTSD~     experiencing such difficulties and would help prevent the detrimental consequences that can~     come from anger and aggression among these individuals.~   "
13329|NCT02882789|"~     Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous~     dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary~      • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose~   "
13330|NCT02882776|"~     This study aims to examine the effect of ginger beverage consumption on platelets activity~     in apparently healthy Saudi adult volunteers.~      As for the Saudi population, consumption of powdered ginger dissolved in hot water is a~     common practice. Accordingly, in this study, it is tempting to speculate the effect of this~     form of ginger consumption, given in separate time points per day, on platelet aggregation~     profile by using platelet aggregation analogues. If positive results were obtained, the herb~     could provide natural protection against the development of platelet aggregation~     complications and could be a potential alternative to aspirin, used for improving blood~     circulation and hematological pathophysiologies in diseased individuals.~   "
13655|NCT02878538|"~     The investigators propose to conduct a series of N of One (No1) single blinded clinical~     trials to pilot the feasibility of using the iron-chelator deferiprone on Mild Cognitive~     Impairment (MCI). Chelation therapy has previously been reported to slow the rate of~     cognitive decline in Alzheimer's Disease (AD) by 50% in a single human randomized clinical~     trial.~   "
13331|NCT02882763|"~     ZEPPELIN (Zurich Equity Prevention Project with Parents Participation and Integration) is a~     longitudinal, randomized controlled intervention study. The main objective is to examine the~     effectiveness of the early intervention program Parents As Teachers (PAT) in~     psychosocially disadvantaged families. This includes four aims:~        1. Identification of children at risk at an early age, using an interdisciplinary network;~        2. Investigation of the acceptability of the program by the parents;~        3. Evaluation of the intervention process and efficacy during and immediately after~          program implementation;~        4. Evaluation of the efficacy in terms of child academic performance.~   "
13332|NCT02882750|"~     This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection~     and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with~     this information the Shared Decision Making (SDM) process.~      300 consecutive patients will be followed up from prior the treatment to 12 months~     afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18,~     Decision Self-Efficacy Scale) by a remote web-based system.~      Deliverable:~        1. Differences after VATS resections or SABR in terms of physical and psychological~          symptoms, quality of life and satisfaction~        2. Patient perspectives of the Shared Decision Making Process.~   "
13333|NCT02882737|"~     This project is part of several studies exploring situations, where glucagon potential has~     lesser glucose elevating effect. Exercise can be one of these situations as exercise may~     reduce liver glycogen depots.~      The investigators aims are:~        1. To compare the increase in plasma glucose after 200µg glucagon given either after~          exercise or after resting for 45 minutes.~        2. To determine whether a subcutaneous glucagon injection just before exercise has a~          greater impact on hepatic glucose production and thereby is superior to an injection~          after exercise in preventing hypoglycemia during and two hours after exercise.~        3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at~          either the abdominal wall or on the upper arm.~   "
13334|NCT02882724|"~     Background: It has been shown that adults with Multiple sclerosis (MS) have less leg~     strength than their peers, as well as impaired balance, which has led to an increased~     prevalence of falls in this population.The purpose of this study was to assess the effects~     of 8-weeks aquatic exercise training in balance, endurance and speed in women with MS.~      Methods: In this semi-experimental study, 32 women with clinically-definite~     relapsing-remittent MS who were registered through the Isfahan MS association volunteered~     for this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15)~     groups. Aquatic exercise group completed a 8-week aquatic exercise training program~     consisted of three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent~     of their maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group~     was instructed to maintain their current lifestyle. The balance of angry was surveyed with~     using of Berg analyze, speed and endurance 6 minutes walking test before starting of~     exercise program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained~     data's were analyzed using analysis of variance with repeated measures.~   "
13335|NCT02882711|"~     The primary objective of this study is to determine the effectiveness of serial infusions of~     intravenous (IV) ketamine in adults with treatment resistant depression (TRD).~   "
13336|NCT02882698|"~     The game Marble Maze Classic® will be used, in which the participants have to move the~     mobile phone to conduct a virtual marble through a maze design. The investigators will~     evaluate 100 individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and~     divide both with DS and TD into group 1 and 2, where each group consists of 25 participants,~     with group 2 using a maze design totally opposite to group 1.~   "
13337|NCT02882685|"~     This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a~     randomized prospective setting. This study also adresses the issue of bile reflux after MGB.~   "
13338|NCT02882672|"~     This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could~     improve adiponectin and cardiovascular disease risk factors in overweight coronary heart~     disease patients. Patients were included in the study if: they were approved to do so~     following a physical, physiological and psychological test; did not take part in regular~     physical activity; had stable heart failure for at least 3 months. Exclusion criteria~     included: a history of surgery within the preceding 4 months; had an unstable angina, acute~     phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy,~     exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure~     more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease;~     exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health~     problems that prevented maximum effort on the treadmill test. Target population included of~     all patients with a history of myocardial infarction and diagnosis of congestive heart~     failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary~     heart disease patients were randomly assigned to either an eight-week, three times weekly~     exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took~     place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute~     warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or~     jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute~     cool-down.~   "
13339|NCT02882659|"~     The primary objective of this study is to evaluate the safety of autologous dendritic killer~     cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated~     dose (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination,~     assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE).~     The secondary endpoints regarding efficacy includes the generation of tumor specific immune~     response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of~     life~   "
13362|NCT02882360|"~     Pregnant women with BMI>40 will be approached for participation in a study to reduce the~     rate of post-operative wound infection from C-section. Women will be randomized to a~     commonly used wound product (Kerlix-AMD) which consists of a PHMB-impregnated gauze versus~     normal gauze, and rates of post-operative surgical site infection will be assessed. Women~     with a planned procedure will also be randomized to applying Kerlix versus gauze for 3 days~     pre-operatively to determine if this improves outcomes as well.~   "
13656|NCT02878525|"~     The purpose of this study is to study the effectiveness of laparoscopic internal gastric~     banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy~   "
13340|NCT02882646|"~     In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the~     frequent strategy used over bilateral ones. However, the clinical need for bilateral~     training is supported by evidence that shows that unilateral training of the impaired limb~     does not automatically restore bimanual coordination and function. Increased focused is~     needed on developing more robot-assisted therapy that can train the impaired arm bilaterally~     and unilaterally. Controlling these robots is often difficult and requires a better~     understanding of the coupling effects of the left and right hand before and after a stroke.~     There is a need to develop robot-assisted therapy devices that can address coupled and~     uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human~     bimanual actions along with the intermanual division of labor in various ADL tasks. This~     study focuses on bilateral training and the use of bio-inspired control algorithms to~     understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke~     subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a~     stroke or cerebral palsy will be evaluated by a member of the research team and asked to~     perform a battery of tasks to test the viability and usability of a bilateral robot system~     called BiADLER, which allows patients to complete daily tasks with varying levels of~     assistance to adapt task performance to each individual subject's performance. Subjects will~     to provide feedback to the researchers on their observations and thoughts about the therapy~     devices.~   "
13341|NCT02882633|"~     The purpose of this study is to compare lumbar plexus block to fascia iliac block done in~     adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid~     consumption, and quality of recovery 48 hours post operatively will be used for comparison.~   "
13342|NCT02882620|"~     Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and~     survival in the general U.S. population have been attributed to routine screening with~     prompt removal of polyps, early detection, and timely and appropriate treatment. American~     Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes~     and are significantly less likely than non-Hispanic Whites to receive recommended CRC~     screening. The purpose of this three-arm randomized controlled trial is to determine the~     efficacy of interventions designed to enhance CRC screening. The study also uses mixed~     methods to finalize the intervention and to determine promoters and barriers of screening.~     The study also conducts process evaluation to determine cost-effectiveness of the~     interventions, fidelity of study implementation, and to develop plans to sustain and~     scale-up the intervention model. The study will determine the efficacy of serially~     implemented interventions of graded intensity for increasing CRC screening using the fecal~     immunochemical test (FIT) in accordance to recommended guidelines among average risk~     American Indians (AIs) aged 50-75 residing on reservations in rural Southwestern U.S. Serial~     implementation refers to offering routine screening, irrespective of response to an earlier~     invitation, in concordance with guidelines which recommend annual FIT testing between ages~     50-75. The FIT is most appropriate because it is an approved, high sensitivity fecal occult~     blood test and is available at Indian Health Service (IHS) and tribal health facilities~     where resources to provide screening colonoscopy are limited. The study is a collaborative~     effort between the Albuquerque Area Indian Health Board (100% Indian-owned and operated),~     six Pueblo Tribes in rural Southwestern U.S., and the University of New Mexico. Findings~     from this research could lead to an immediate increase in CRC screening and ultimately~     reduce CRC burden among AIs, thus addressing national and tribal priorities of reducing CRC~     disparities among AIs.~   "
13343|NCT02882607|"~     The purpose of this study is to test the efficacy of an innovative, culturally relevant,~     community-based peer group intervention to increase young rural Malawian women's~     preconception behaviors to optimize their reproductive health. The study uses a~     longitudinal, two group (two-arm) design with a delayed control group.~   "
13344|NCT02882594|"~     The overall objective of the study is to improve the experience for pediatric patients~     undergoing anesthesia inductions. The specific objective for this proposal is to establish~     whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the~     Induction Compliance Checklist.~   "
13345|NCT02882581|"~     The general purpose of the trial is to investigate whether metformin is taken up into the~     breast tumor. Studies in the last few years have shown an effect of metformin on cell~     proliferation on breast cancer. It is though unclear whether the effect on tumor is direct,~     indirect or a combination of the two. The investigators plan to:~        -  investigate if metformin is taken up in breast cancer using our novel 11C-metformin~          tracer and positron emission tomography (PET)~        -  investigate whether the uptake is correlated to the amounts of organic cation~          transporters (OCT1-3, MATE 1 &2 and PMAT) using quantitive polymerase chain reaction~          (qPCR).~   "
13346|NCT02882568|"~     Improve knowledge of the immune response to sepsis in obese patients. Define immunological~     and genetic prognostic factors of severe infections which can motivate a change in the~     therapeutic attitude~   "
13347|NCT02882555|"~     The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise.~     The purpose of this study is to determine if a short muscular exercise inhibits the cough~     reflex induced by capsaicin inhalation.~   "
13348|NCT02882542|"~     NOTE: This is the third of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
13349|NCT02882529|"~     NOTE: This is the second of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
13383|NCT02882087|"~     This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study~     of the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor~     receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists~     due to treat moderate and severe rheumatoid arthritis.~   "
13350|NCT02882516|"~     NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response~     to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
13351|NCT02882503|"~     Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to~     the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms.~     Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary~     mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard~     treatment of solid or cystic pancreatic lesions with malignant potential has been surgical~     resection, with lesions in the pancreatic head requiring a Whipple resection whereas~     pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection~     carry significant morbidity and mortality. The study would like to outline the feasibility,~     safety, adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency~     ablation (RFA) in pancreatic neoplasms.~   "
13352|NCT02882490|"~     This is a randomized controlled trial to assess the efficacy of a parent training program to~     control disruptive behaviors in children with Tourette Syndrome.~   "
13353|NCT02882477|"~     Patients who are genetically diagnosed with the recently reported and rare Wolfram syndrome~     type 2 ( WFS2) and have the degenerative and symptomatic disease including signs such as~     diabetes, platelet aggregation defect or visual problems will be asked to participate in~     this study. Knowing the pathomechanism of WFS2 with rapid cell death, after doing baseline~     investigations to asses the severity of their disease, the participants will be offered a~     chelator therapy with in addition to the antioxidant Acetylcystein, in diabetic patients an~     Incertin (GLP-1 ) therapy will be offered as well. The baseline investigations will be~     repeated after 2 months and after 5 months of therapy in order to asses the progression of~     the disease and to show if the chelator and anti oxidant therapy and in diabetic patients~     the GLP-1 therapy could stop the progression of the disease.~   "
13354|NCT02882464|"~     Miller Class I Gingival Recessions (GR) have been treated by using Coronally Advanced Flap~     (CAF) with Platelet Rich Fibrin membrane (PRF membrane) or Connective Tissue Graft (CTG).~     The aim of this study was to evaluate the effect of different multiple layers of PRF~     membranes for the treatment of GR and compare the results with CTG procedure.~   "
13355|NCT02882451|"~     Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS)~     and functional disorders of the biliary tract. In this study, pinaverium bromide was~     compared with Vitamin C for the facilitation of bile duct cannulation in patients. The~     primary outcome was successful deep bile duct cannulation. The second outcome was the major~     papillary orifice, bile juice flow from the papilla, time to achieve deep bile duct~     cannulation, and fluoroscopy time for deep bile duct cannulation in the pinaverium bromide~     group versus Vitamin C group.~   "
13356|NCT02882438|"~     Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a~     fungal infection of the feet and it is easily spread. Oral therapy is usually used for~     chronic conditions or when topical treatment has failed. The aim of this study is to prove~     the antifungal and antibacterial activity of Ginko Biloba (GKB) & Glucosamine (GL) as~     separate material or both in combination.~   "
13357|NCT02882425|"~     The primary purpose of this phase 1 study is to investigate the absolute bio-availability of~     a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the~     blood when administered as an oral tablet (ACT-293987) compared to an intravenous~     administration in healthy subjects.~   "
13358|NCT02882412|"~     Long-term use of opioids for chronic pain is a growing health and social problem, mainly~     because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy~     for opioid dependence. This substitution therapy in patients with opioid dependence lessens~     withdrawal symptoms and craving. There is limited research on the effectiveness of~     buprenorphine/naloxone in patients with chronic pain and iatrogenic opioid dependence. The~     primary aim of this study is to investigate the effectiveness of buprenorphine/naloxone in~     patients suffering from chronic pain and an iatrogenic induced dependence on opioids. This~     study will investigate the effects of opioid substitution by buprenorphine/naloxone in~     patients suffering from chronic pain using long-term opioids, with pain and withdrawal~     symptoms as primary outcome measures. Secondary outcome measures will be craving, substance~     use, psychiatric comorbidity and quality of life.~   "
13359|NCT02882399|"~     The pubic and abdominal pathology is common among athletes. It leads to a shutdown of~     physical activity for several months, and requires rehabilitative care, or surgery for a~     permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of~     sports.~   "
13360|NCT02882386|"~     The aim of this study is to investigate the amino acid kinetics in blood after a bout of~     strength training and ingestion of different milk protein supplements (native whey, whey~     protein concentrate 80, hydrolysed whey, microparticulated whey and milk) The investigators~     hypothesize that native whey will give a faster and higher rise in blood concentrations of~     leucine compared to the other milk protein supplements.~   "
13361|NCT02882373|"~     The goal of this clinical research study is to learn if L-arginine can help control side~     effects of anti-cancer drugs such as high blood pressure, protein in the urine, and kidney~     problems. L-arginine is a nutritional supplement and will be compared to a placebo in this~     study.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
13622|NCT02878967|"~     The time-frame and the follow-up elements after embolization of brain aneurysm are not~     standardized. Therefore, few reliable follow-up data are available for these patients.~      This study aims at collecting standardized long term data for these patients, in order to~     assess the occurence of aneurysm recanalization and particularly those requiring another~     intervention on the aneurysm.~   "
13363|NCT02882347|"~     Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient~     death, however, definite treatment strategy has not been established. The liver is a~     regenerating organ and the possibility of PHLF could be reduced when the appropriate liver~     regeneration is guaranteed.~      Portal flow has known to be important during liver regeneration. Low portal flow cannot~     induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic~     sinusoid resulting liver failure.~      Various medications has been used in malignant liver cirrhosis to reduce portal pressure.~     Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal~     pressure.~      In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to~     PHLF patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver~     resection) until recovery from liver failure. For assessment of the recovery of liver~     failure, the investigators evaluate aspartate transaminase (AST), alanine transaminase~     (ALT), serum total bilirubin and prothrombin time periodically after administration of~     medication.~   "
13364|NCT02882334|"~     Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures~     during writing. Limited finger independence during writing manifests as difficulty~     suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also~     have difficulty in fine control of grip force. However, some previous studies indicate~     positive effects of individual finger movement training in WC although these studies lacked~     enhanced visual feedback of activations in 'stationary' fingers. The investigators have~     recently developed the Finger Force Manipulandum which quantifies the forces applied by the~     fingers in different tasks. This method is sensitive for detection and quantification of~     small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary'~     fingers can be displayed on-line providing enhanced feedback on independence of finger~     movements. The aim of this study is to test the effectiveness of finger individuation~     training using the FFM to improve symptoms in WC patients.~   "
13365|NCT02882321|"~     This clinical research study has 2 parts: dose escalation and dose expansion.~      The goal of dose escalation in this clinical research study is to find the best dose of~     IACS-010759 that can be given to patients with relapsed or refractory AML.~      The goal of dose expansion in this clinical research study is to learn if the dose of~     IACS-010759 found in the dose escalation part of the study is the best dose to use in future~     studies using IACS-010759 in patients with AML.~      The safety and tolerability of this drug will also be studied.~      This is the first study using IACS-010759 in humans.~   "
13366|NCT02882308|"~     OPHELIA (OlaParib in patients with HEad and neck squamous-celL carcInomA) trial is a Greek,~     investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients~     with operable histologically documented squamous-cell carcinoma of the oral cavity,~     oropharynx, hypopharynx or larynx will be randomized between combination with cisplatin and~     olaparib, monotherapy with olaparib or no treatment, before standard treatment.~   "
13367|NCT02882295|"~     Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts~     writing. It leads to partial or complete inability to use the hand only during the~     handwriting gesture. It is characterized by the appearance of cramps or spasms of certain~     muscles of the hand and/or forearm.~      Clinical scales currently use for the assessment of WC fail to accurately reflect changes in~     the characteristics of handwriting in response to treatments (Botulinum Neurotoxin~     injections and / or retraining therapy).~      The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information~     in terms of speed and precision of handwriting gesture. This timed handwriting test is to~     follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the~     time in seconds required to carry out the zigzag path and count the number of errors (output~     path and contacts with obstacles). The investigators propose to validate the ZZTT for the~     assessment of the handwriting gesture of WC.~   "
13368|NCT02882282|"~     The goal of this clinical research study is to compare pembrolizumab to standard of care~     observation (no treatment) in controlling oral pre-malignant lesions and IENs. The safety~     and tolerability of pembrolizumab will also be studied.~   "
13369|NCT02882269|"~     A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant~     chemotherapy with postoperative chemotherapy in patients with resectable locally advanced~     colon cancer~   "
13370|NCT02882256|"~     Patients seen in the ED with either a laceration, minor head injury, or urinary tract~     infection will be randomized to one of two groups. Both groups will receive the standard~     written discharge instructions; in addition, one group will watch video discharge~     instructions. Each patient will be asked to complete a short survey with questions related~     to the discharge instructions received in the ED, and will be called 5-7 days after the ED~     visit to ask questions about discharge instructions and the ED visit.~   "
13371|NCT02882243|"~     This investigation will provide safety and effectiveness information on the use of the~     FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by~     evaluating:~        -  Safety as measured by the rate of serious operative and post-operative complications.~        -  Patients' quality of life, measured by health-related quality of life questionnaires up~          to 24 months following the procedure, as compared to patient's baseline.~   "
13372|NCT02882230|"~     The frequency of neurological and psychiatric complaints for participants taking~     rilpivirine, elvitegravir, or dolutegravir reaches on average 20—30% during clinical trials.~     The inclusion and exclusion criteria for enrolling people living with HIV are at times so~     selective and the subsequent descriptions of minor or severe adverse events (AE's) so often~     imprecise and ambiguous that one cannot extrapolate these particular research results to~     practicing medicine. These adverse events negatively affect the patient's quality of life~     and ultimately his or her good adherence to treatments.~      This study aims at assessing the prevalence and at describing the neurological and~     psychiatric adverse events related to these drugs.~   "
13373|NCT02882217|"~     The study focusses on the evaluation of safety and tolerability of the XC8. The design of~     the study involves sequential dosing of cohorts (group of volunteers), taking increasing~     doses of the product after receiving conclusion and recommendation for further continuation~     of the study from the Dose Escalation Committee.~   "
13674|NCT02878291|"~     The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide~     conjugate vaccine in healthy volunteers aged above 3 Months~   "
13374|NCT02882204|"~     The investigators propose to study the brain processes that result in thought and language~     disorder and influence outcomes seen in patients with schizophrenia using a combination of~     brain scans and clinical assessments. The project will assess patients at various stages of~     psychosis (first episode and chronic stage >3 years of illness) referred to the Prevention~     and Early Intervention in Psychosis Programme using Magnetic Resonance Imaging (MRI scans).~     To track the outcome of this illness, investigators will follow-up patients over 3 years and~     collect MRI scans over four sessions for each patient. Participants will also complete a~     clinical assessment examining symptoms and functioning as per the current clinical practice~     within the PEPP program.~   "
13375|NCT02882191|"~     To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to~     support commencing a Phase III Clinical Study~   "
13376|NCT02882178|"~     Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of~     metastatic castration-resistant prostate cancer. To investigate whether the precautions for~     the use of cabazitaxel (contraindications, hepatic function, premedication for~     hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions~     of administration) are respected in routine practice, an observational cohort study will be~     implemented in 32 oncology centres of South-West region of France (CABOBS study). The~     primary objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions~     with the Summary of Product haracteristics (SPC) in clinical practice (indications and~     monitoring methods) and according to the conditions of use. Panel of experts were convened~     to assess the conformity of prescription of cabazitaxel with a Delphi consensus method. The~     Delphi method is most suited to areas where a limited number of evidences are available to~     enable a recommendation or guidelines to be drawn. Moreover, all the evaluated items came~     from an official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected~     from the experts to select the most relevant items. In the frame of the CABOBS study, this~     method will allow to select items of the SPC list according to their importance, and to~     define the primary objective of conformity to cabazitaxel conditions of use.~   "
13377|NCT02882165|"~     Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally~     induced lung damage e.g. cigarette smoking and air pollution which, over time, causes~     individuals to suffer from symptoms including chronic cough and progressive breathlessness.~     In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades~     before the symptoms appear and the disease is diagnosed.~      The aim of this study is to identify those COPD patients who currently have milder disease~     and to investigate whether a detailed, medical assessment which has time to assess all~     aspects of their care will improve their lung health and general wellbeing.~      COPD is a major cause of disability and death in the UK, with around 835,000 people~     currently diagnosed with the disease and an estimated further two million people who suffer~     from symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die~     from COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in~     England and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes~     an enormous symptom burden to patients, and accounts for up to half of emergency admissions~     to already overstretched hospital services in England (4).~      People with COPD, with a past history of smoking, are at higher risk of other medical~     problems such as heart disease and stroke(5). Being breathless and having multiple physical~     health problems can also lead to mental health problems such as anxiety and depression(5).~     This means it can be challenging to provide this group of people enough time to fully assess~     and treat all their problems, particularly due to current pressure on the length of GP~     appointment times.~      Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and~     intervention provided a key part of the strategy for COPD published by NHS England in~     2012(6). With early diagnosis, the opportunity is provided to intervene with the aim of~     improving symptoms and exercise tolerance, reducing the risk of exacerbations, slowing~     deterioration and prolonging quality of life.~   "
13378|NCT02882152|"~     Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia~     and postoperative bleeding from intrathecal morphine with the continuous femoral and a~     single-shot sciatic nerve blockades.~   "
13379|NCT02882139|"~     Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP)~     and ventricular fibrillation (VF)) represent a major event in the clinical history of a~     patient and they can lead to hemodynamic instability and sudden cardiac death (SCD).~     Recurrences of ventricular arrhythmias and electrical instability have exponentially~     increased in the last decades and a new clinical entity called electrical storm (ES) has~     emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more~     sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia~     lasting 12 hours or more and that does not respond to treatments.~      Most of the patients presenting ES are already implanted with an ICD. This is due to 3~     factors: first, patients with ICD implant are at higher risk to develop ventricular~     arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records~     and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would~     not be detected. Third, and more important, the device gives the possibility to survive to~     an arrhythmic episode, making it possible for the patient to experience an ES. The incidence~     of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for~     secondary prevention and from 4 to 7% in patients with ICD for primary prevention.~      The aim of the ELECTRA registry is twofold:~        1. To create an international registry on clinical features, optimal therapy, ablation~          strategy, prognosis and the effect of ICD programming on patients with ES.~        2. To use the data derived from the registry for a prospective, observational study on~          mortality and rehospitalization rate in patients with ES.~   "
13380|NCT02882126|"~     This is a multicenter, open-label trial to evaluate the safety of continued therapy with~     subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete~     the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial~     centers in China who completed all required assessments in the CVT-CV-003 study. Study~     visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months~     until the study is discontinued by the sponsor.~   "
13381|NCT02882113|"~     This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated~     clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality~     and the trough level change after conversion to Advagraf® in liver transplant recipients.~   "
13382|NCT02882100|"~     This study is powered to prospectively evaluate the relative effectiveness of adjuvanted~     trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality,~     hospitalization, and functional decline in a nursing home population in the U.S., compared~     to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV;~     Fluvirin).~   "
44513|NCT02474589|"~     Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and~     tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.~   "
13384|NCT02882074|"~     The purpose of this study is to evaluate whether patients receiving human albumin for plasma~     volume replacement during cardiac surgery have improved postoperative endothelial function~     compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative~     endothelial function, measured with peripheral arterial tonometry as reactive hyperemia~     index (RHI) within 2 hours following surgery, will be compared in cardiac surgical patients~     randomized to receive human albumin or 6% HES solutions for intraoperative volume~     replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using~     EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will~     perform additional EndoPAT measurements to describe the expected changes that occur in~     endothelial function during the perioperative period (baseline, early postoperative and 24~     hours postoperative) using RHI.~      This study will also determine whether human albumin 5% reduces plasma biomarkers of~     endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and~     endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples~     will be taken on the morning of the surgery, within one hour of arrival to the intensive~     care unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU~     (three times altogether). These samples will be used to measure the plasma concentrations of~     two biomarkers that measure endothelial injury.~   "
13385|NCT02882061|"~     Neck pain is a very common diagnosis and physical therapy, specifically thoracic~     manipulation, has been shown to be an effective treatment. Thoracic manipulation, which~     involves a quick thrust type push to a segment of the midback region of the spine, has been~     shown to decrease pain and improve function in individuals with neck pain. However, it is~     not known if there is a test that will accurately identify individuals with neck pain who~     would respond more favorably to thoracic techniques. The Cervical-Thoracic Differentiation~     Test (CTDT) is a test used clinically to differentiate pain originating from either the~     cervical (neck) or thoracic (midback) regions of the spine in individuals with neck pain. It~     has also been speculated that specific unloading tests, where a tester selectively unloads a~     portion of the weight of the cervical or thoracic spine through manual distraction may help~     determine who will respond more favorably to thoracic treatment. To the best of our~     knowledge, despite widespread clinical use, these tests have not been tested for validity or~     reliability at this time. Therefore, the purposes of this research are to assess the~     reliability and criterion referenced validity of the CTDT and unloading tests, as well as~     examine the relationship between tests and baseline subject characteristics.~   "
13386|NCT02882048|"~     This study is to compare two groups undergoing opioid weaning as ordered by their referring~     physicians. One group will undergo the standard opioid weaning process and the other group~     will have the addition of the NADA Protocol to the weaning process.~   "
13387|NCT02882035|"~     66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet~     Institute, the Belgian oncology institute. One group received an opioid anesthesia, the~     other group an opioid free one. The hypothesis of this study was that opioid free anesthesia~     improves the postoperative quality of recovery of anesthesia.~   "
13388|NCT02882022|"~     This study is an investigation into the effect that CPAP has on the pressure in the middle~     ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of~     CPAP pressure delivered via a full face mask. These measurements will be used to determine~     optimal levels of CPAP to affect individual's middle ear pressure, particularly those with~     negative middle ear pressure due to Eustachian tube dysfunction.~   "
13389|NCT02882009|"~     The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to~     assess pain following subcutaneous (SC) administration of gantenerumab as a~     high-concentration liquid formulation (HCLF) at different injection speeds. The total~     duration of the study for each healthy participant will be up to approximately 21 weeks.~   "
13390|NCT02881996|"~     The objective of this study is to evaluate two standard post-operative pain regimens~     routinely used after laparoscopic appendectomy for perforated appendicitis. The~     investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV~     ketorolac with narcotic pain pump will decrease time to transition off patient/nurse~     controlled analgesia (PCA) to oral pain medications.~   "
13391|NCT02881983|"~     Background:~      Difficulties in assigning and identifying emotional states, or to regulate the emotional~     costs are recognized as one of the major factors of relapse. This study aimed to evaluate~     the emotion regulation processes, in short term (STA, after 1month of withdrawal) and~     long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared~     to healthy control participants (C) in a positive and negative emotion induction protocol.~      Main aim:~      Evaluating the emotional regulation deficits assessed with physiological indicators (heart~     rate variability, electrodermal response, pupil diameter) and clinically in presentations of~     visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's~     (AUD) patients with short and long term abstinent compared to a control group of healthy~     subjects. The investigators are particularly interested in the evolution of heart rate~     variability considered as a good marker of vulnerability to AUD.~      Secondary objectives:~      Studying the relationships between physiological measures and clinical variables such as~     behavioral indicators and self-reported assessment of cognitive and emotional skills among~     the three groups (STA, LTA and C).~   "
13392|NCT02881970|"~     Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain~     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal~     damage and loss.~      Currently, only total or partial body hypothermia can partially prevent cell loss. However,~     no treatment exists to restore neuronal functions.~      Cord blood stem cells are a promising treatment for the near future.~      The primary objective of this study is to test the safety and feasibility of a curative~     treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.~      The secondary objectives are to test the efficacy of this curative treatment with cell with~     neurogenic potential on the prevention of neurologic sequelae, as well as to test the~     optimum timing of cell preparation administration~   "
13740|NCT02877433|"~     This study aims to compare the clinical performance of 4 mm short implants supporting~     cross-arch fixed reconstructions in the edentulous mandible either with a combination of two~     short implants as distal support and two implants of conventional length placed in the~     interforaminal region, or with a combination of four short implants as distal support and~     two interforaminal implants of conventional length.~   "
13393|NCT02881957|"~     Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized~     clinical trials within an intensive care unit (ICU) environment. Despite these findings,~     there have been no studies examining the impact of hypovitaminosis D in specialized~     neurocritical care units (NCCU). Given the often significant differences in the management~     of patients in NCCU and more generalized intensive care units there is a need for further~     inquiries into the impact of low vitamin D levels in this specific environment. This study~     proposes a randomized, double-blinded, placebo-controlled, single center evaluation of~     vitamin D supplementation in the emergent NCCU patient population. The primary outcome will~     involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes,~     including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge,~     complications and quality-of-life metrics. Patients will be followed for 6 months~     post-discharge.~   "
13394|NCT02881944|"~     Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are~     poorly digested in intestines. The undigested carbohydrates are fermented in the colon by~     gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension~     of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by~     production of chemicals that influence Veteran's intestines which then result in reduced~     disease symptoms.~      The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP~     (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.~   "
13395|NCT02881931|"~     The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information~     coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion~     through self-report. The purpose of this study is to identify real or potential~     comprehension or usage problems with questionnaire items or response options. Through a~     process of structured cognitive de-briefing with HDGEC participants and companions,~     independently, followed by qualitative analysis, the final phrasing of the individual items~     and response options for the scale will be generated. Depending on the results of the first~     round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.~   "
13396|NCT02881918|"~     The purpose is the description of anti-tumor immune responses in general and according to~     clinical stage and disease free survival (DFS: survival without recurrence (local or~     distant)) in patients with Head & Neck Squamous Cell Carcinoma~      Secondary purposes are:~        -  Study of relationship between anti-tumor immune response and qualitative (yes/no) and~          quantitative (number) presence of circulating tumor cells (CTCs);~        -  Study of relationship between qualitative (yes/no) and quantitative (number) presence~          of CTCs and clinical stage as well as DFS~        -  Study of relationship between anti-tumor immune response and clinical stage as well as~          DFS.~   "
13397|NCT02881905|"~     There is a significant difference between CM LOC and ball attachment, when considering the~     peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives~     are to determine if CM LOC attachment improves the peri-implant soft tissue response and~     decreases the marginal bone loss around implant when compared to conventional ball~     attachment~   "
13398|NCT02881892|"~     The aim of study was to evaluated the correlation between plasma levels, dialysate~     appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis~     adequacy in CAPD patients.~   "
13399|NCT02881879|"~     The aim of the study is to evaluate the safety and tolerability of subcutaneous~     immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis~     with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity.~      It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5~     participating spanish sites.~      Primary endpoint of the study is to assess the safety and tolerability of subcutaneous~     immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis~     with or without mild asthma sensitized to house dust mites~      Secondary objective is to evaluate the indirect immunotherapy efficacy through the~     measurement of immunoglobulin level changes and cutaneous reactivity~   "
13400|NCT02881866|"~     This study evaluates the effect of inhaled furosemide on different types of breathlessness~     relief in healthy volunteers. Each volunteer inhaled mists of either furosemide or a control~     substance on 3 occasions per day on 2 separate days. On one day they performed one~     breathlessness test which creates an 'urge to breathe' known as air hunger (AH) and the~     other day they performed a breathlessness test which increases the sense of work/effort (WE)~     of breathing. The study is double blinded so neither the volunteer or the research knows~     which mist is being inhaled.~   "
13401|NCT02881853|"~     This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and~     multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in~     healthy subjects and in subjects with atopic disease.~   "
13402|NCT02881840|"~     Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass~     balance recovery, metabolite profile, metabolite identification and pharmacokinetics of~     14C-labelled APD421~   "
13403|NCT02881827|"~     The purpose of this study is to obtain experimental data on the possible changes that saliva~     may suffer when brought to low-level laser therapy protocols for analgesia in the masseter~     muscle, because this be on the Parotid salivary gland.~   "
13413|NCT02881697|"~     The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine~     protein kinase that controls growth and metabolism. In mammals (including humans), mammalian~     TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene.~     In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin~     resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet~     (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic~     insulin resistance, investigators have already performed transcriptomics and proteomics~     analysis on visceral white adipose tissue in a mouse model. The aim of the study is to~     confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.~   "
13414|NCT02881684|"~     This research project will provide insight into the efficacy and safety of aspiration~     therapy in the management of obesity and its comorbidities in the Asian population, and will~     determine if there is a role for this novel endoscopic device in the treatment algorithm of~     obesity in the investigators' local regions.~   "
13404|NCT02881814|"~     The physiotherapist in the ICU is involved in taking patient's respiratory load, especially~     in the treatment of ventilation disorders, swallowing disorders, weaning from mechanical~     ventilation, aerosol therapy, oxygen therapy and the establishment noninvasive ventilation~     (NIV).~      The choice of one or more techniques, defining the modalities of treatment in respiratory~     physiotherapy, is at the end of a systematic, focused and disciplined. Patient evaluation is~     necessary to determine the indication for respiratory physiotherapy, choose the method of~     treatment and monitor patient progress and evaluate the effectiveness of the treatment.~      When the physical therapist patient assessment usually used clinical examination, blood~     gases, auscultation and thoracic imaging. However, the diagnostic accuracy of chest~     radiograph and auscultation is weak with regard to the pathologies which may indicate~     respiratory physiotherapy in the ICU: pulmonary consolidation, pleural effusion, atelectasis~     or interstitial syndrome. Thoracic CT remains the gold standard in the evaluation of lung~     parenchyma but requires patient transport, exposed to radiation and is more expensive.~     Compared to CT, lung ultrasound has greater sensitivity and specificity than the radiography~     in the diagnosis of these pathologies. It also assesses the diaphragm with greater accuracy~     and reproducibility than the tools Routine measurements (Maximum inspiratory pressure,~     P0.1). Ultrasound can diagnose dysfunction in intensive care with excellent sensitivity and~     specificity compared to the measurements of transdiaphragmatic pressures.~      The French physiotherapist is authorized to perform an ultrasound as part of its balance~     sheet (4), pulmonary and diaphragmatic ultrasound could allow the therapist to clarify the~     indication for respiratory physiotherapy and avoid unnecessary or inappropriate treatments.~     This provision of information may also change the therapeutic management of the~     physiotherapist. Given its relatively recent appearance, the interest of the use of~     pulmonary and diaphragmatic ultrasound respiratory physiotherapy has never been evaluated.~     Xirouchaki et al. evaluated the impact of lung ultrasound on the physician's clinical~     decision among ICU patients and showed that it significantly influenced the medical~     diagnosis and modified the therapeutic management. A ur knowledge, no study has evaluated~     the impact of the information provided by ultrasound in the clinical decision-making in~     respiratory physiotherapy in patients hospitalized in intensive care or not~   "
13405|NCT02881801|"~     This study aims to describe the pattern of active and sedentary time in survivors of a~     critical illness, at three time points during their hospital admission (awakening in the ICU~     after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital).~      The specific research objectives are to~        1. Determine the duration of active and sedentary parameters including time and bouts in~          24 hour periods~        2. Examine changes in the active and sedentary parameters including time and bouts between~          time points of awakening and both ICU and hospital discharge.~        3. Conduct a preliminary examination of relationships between activity and sedentary~          behaviour metrics with measures of muscle strength, physical function and hospital~          length of stay.~   "
13406|NCT02881788|"~     Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase~     awareness regarding brain health and its maintenance as well as increasing awareness of the~     impact of alcohol on brain function. In the immediate future, we hope to obtain data from a~     non-injured normative, diverse population represented by the state fair patrons.~   "
13407|NCT02881775|"~     The purpose of the study is to identify things that influence the ability to turn on the~     thigh muscle (quadriceps). The thigh muscle tends to be under active with knee~     osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are~     also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to~     determine whether it may help turn up activity in the under active thigh muscle~     immediately after its application. rTMS uses a targeted pulsed magnetic field, similar to~     what is used in an MRI (magnetic resonance imaging) machine to send an electrical signal~     from the brain to the thigh muscle.~   "
13408|NCT02881762|"~     This is a single-site, longitudinal, open-label, interventional study for evaluating the~     effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C~     and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.~   "
13409|NCT02881749|"~     The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low~     dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous~     T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose~     TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and~     confirmation that their disease stage has been downgraded to IA or IB, subjects will use~     Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a~     maintenance drug will be followed clinically through Modified Severity Weight Assessment~     Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will~     be followed histopathologically through skin biopsies performed at the screening visit,~     immediately after observation period, one month after the start of the maintenance period,~     and twelve months after the start of the maintenance period (4 biopsies total).~   "
13410|NCT02881736|"~     Clinical assessment of motor and sensory deficits is still today largely based on tests that~     do not permit any precise quantification. However, robotic technologies, coupled with~     neuroimaging techniques constitute new tools to assess sensorimotor functions that could~     allow to conceive neurorehabilitation protocols better adapted to the neurological~     impairment of each patient and to her/his specific recovery profile.~      The goal of this project is to contribute identifying the factors that determine functional~     recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our~     research on two factors that contribute in a complementary way to motor control: 1) the~     processing of proprioceptive informations, and 2) the processing of movement-execution~     errors. In this purpose, we will combine psychophysical methods that allow to precisely~     quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More~     specifically, we will exploit experimental protocols that have been developed in basic~     research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely~     quantify motor and proprioceptive deficits in stroke patients. Then, we will link these~     behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation~     task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI)~     completed by diffusion tensor images (DTI) in order to achieve a finer description of the~     cerebral lesions.~      The present study will include two experimental parts, respectively centered on the~     proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution~     errors (Part 2).~      Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present,~     deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially~     to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in ~     proprioception for action  are more determinant than deficits in the conscious sense of~     position (classically tested in clinics). In this purpose, we will collect three sets of~     behavioral data, in chronic stroke patients and healthy control participants, respectively~     intended to assess a) motor deficits, b) troubles in conscious sense of position, and c)~     deficits in proprioception for action. To better document the neuronatomical substrates of~     these different types of deficits. In this purpose, we will link the obtained behavioral~     data with the results of detailed analyses of the lesions of the tested stroke patients.~      Anomalies in the processing of movement-execution errors in stroke patients : We will assess~     movement-execution error processing in stroke patients, in order to test the idea that~     anomalies in error processing might contribute to motor deficits in stroke patients. In this~     purpose, we will record an electrophysiological correlate (ERP) of movement-error processing~     during a motor adaptation task. We will analyse the relation between the modulation of this~     ERP and motor performance. We will also examine the relation between these two sets of data~     (behavioral and electrophysiological) and the behavioral data collected during the first~     part of the study (Proprioceptive deficits). This will provide us with insight into the~     relationship between proprioceptive deficits and cinematic error processing. As in the first~     part of the study, we will link the observed electrophysiological and behavioral anomalies~     with the results of a detailed analysis of the anatomical lesions of the tested patients.~   "
13411|NCT02881723|"~     The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep~     quality remains poor. Because of a high level of risk of developing an Obstructive Sleep~     Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of~     the impact on quality of life is important in order to propose preventive and therapeutic~     solutions to these patients.~   "
13412|NCT02881710|"~     Multicenter, prospective, uncontrolled study to evaluate variations in urinary~     concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care~     patient.~   "
13415|NCT02881671|"~     Identification of genes involved in congenital atrioventricular block and progressive~     Cardiac Conduction Disease.~   "
13416|NCT02881658|"~     This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled~     clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage~     enriched with plant sterol for 3 weeks. This study also examines if there is other~     health-benefits by consuming the plant sterols fortified soya beverage in terms of serum~     total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and~     musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow~     rate, bio-impedance and body balance.~   "
13417|NCT02881645|"~     The purpose of this study is to assess the effectiveness of a best practices nursing~     protocol in intensive care units on the occurrence of critical incidents compared to the~     common practices.~   "
13418|NCT02881632|"~     A cohort observational study to characterise baseline Structured Light Plethysmography (SLP)~     outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM~   "
13419|NCT02881619|"~     Objectives: This study will determine the effectiveness of preemptive administration of~     etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35%~     hydrogen peroxide.~      Materials and Methods: Fifty patients will be selected for this triple-blind, randomized,~     cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be~     administrated in a single-dose 1 hour prior to bleaching procedure. The whitening treatment~     with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth~     sensitivity will be assessed before, during and 24 hours after the procedure using analog~     visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days~     after each session. Relative risk to sensitivity will be calculated and adjusted by session;~     while comparison of overall risk will performed by McNemar's test. Data on the sensitivity~     level for both scales and color shade will be subjected to the Friedman, Wilcoxon and~     Mann-Whitney tests, respectively (α = 0.05).~   "
13420|NCT02881606|"~     Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1~     presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM~     (CAD/NAM). The aim of the study is to compare between short term clinical effects of both~     interventions as regards alveolar alignment, nasal esthetics and interlabial gap.~   "
13421|NCT02881593|"~     For twenty years, as for other surgical disciplines, new minimally invasive techniques have~     been developed with the main goal the reduction of muscle trauma associated with the~     surrounding roads classic and reduce morbidity linked to this one.~      More recently, minimally invasive methods dedicated to spinal surgery were established, for~     the treatment of herniated discs initially, then for narrow lumbar canals.~      The canal release on minimally invasive fusion, using a tubular system for muscle retraction~     is a new technique that has proven effective: post operative pain reduction of hospital stay~     and blood loss.~      The objective of the study is to investigate the quality of ductal release in these~     minimally invasive fusions.~      Main objective of the study: Evaluation of the quality of the release of post scanners~     operative minimally invasive arthrodesis~      Secondary Objectives: Assessment rates/types of early complications of technical Minimally~     invasive - early postoperative results (postoperative pain, analgesic consumption, length of~     hospital stay, blood loss) - in clinical outcomes in the short and medium term decompression~     after minimally invasive fusion.~   "
13422|NCT02881580|"~     The surgical management of spinal deformities especially in adults is complex. The~     conventional surgical treatment of these deformations is a scope arthrodesis of the spine.~     The quality of the result depends on many variables such as the choice of the vertebrae to~     fuse, location and the number of implants, the type of material used or the type of~     correction maneuver used.~      All these variables affect the surgical outcome and may be involved as a modifiable risk~     factor for possible postoperative complications. The study proposes to focus on the~     junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK) 1.~     Their prevalence in adults ranges from 20% to 43% depending on the series (Yang and Cheng,~     2003; Yagi, King and al.2012).~      The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower~     plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra~     proximal not instrumented (Glattes and al.2005) 4; this measure is being compared to the pre~     operative data.~      Either the CJP are asymptomatic and do not require revision surgery (Yagi King and al.2011)~     5 either they are and thereby generate a revision surgery (Kim Bridwell and al.2008;~     Watanabe Lenke and al.2010) .~      Several factors may potentially influence the development of the CJP. Among them, age,~     preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid~     instrumentation, correction forces applied during surgery, sagittal balance pre and post~     operative degeneration joint capsules, etc. There are few studies on the identification and~     analysis of these risk factors; literature gives only single-center studies on small samples~     10 with a single surgical procedure. Review articles describe the incidence and risk factors~     of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to~     this day.~      The aim of this study is to determine the incidence of occurrence of postoperative kyphosis~     proximal junctional and identify risk factors for developing this major complication of a~     multicenter population of scoliosis operated an extensive fusion.~   "
13423|NCT02881567|"~     The primary objective of the study is to evaluate the effects of treatment with daclizumab~     on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple~     Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab~     due to safety concerns. The secondary objectives of this study in this study population are~     to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse~     activity including the annualized relapse rate (ARR) and the proportion of participants~     experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related~     outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in~     participants previously treated with natalizumab.~   "
13424|NCT02881554|"~     This pilot trial studies how well single photon emission computed tomography~     (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in measuring~     liver function in patients with liver cancer that has or has not spread to other place in~     the body who are undergoing radiation therapy or surgery. Diagnostic procedures, such as~     sulfur colloid SPECT/CT scans, may measure normal liver tissue before, during and after~     treatment and help doctors plan better treatment for liver cancer patients.~   "
13425|NCT02881541|"~     Evaluate the complement of patient care course in the development of proctology outpatient~     surgery (CAP) by providing:~        -  An additional preoperative nurse consultation day hospital~        -  And a phone call from a nurse at D + 1 of the operation~      This corresponds to a reinforced support.~   "
13495|NCT02880631|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO System in the commercial setting in subjects recently implanted under the CE-Marked~     indication for resistant hypertension.~   "
13496|NCT02880618|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO System in the commercial setting in subjects recently implanted under the CE-Marked~     indication for heart failure with reduced ejection fraction (HFrEF).~   "
13426|NCT02881528|"~     The autoimmune diabetes ACCELERATOR PREVENTION TRIAL (adAPT) is based on the accelerator~     hypothesis. The trial is designed to establish whether metformin, an oral hypoglycaemic~     agent that is known to reduce insulin demand in type 2 diabetes (T2D), can do the same in~     children at risk of type 1 diabetes (T1D) and thereby prevent disease.~      The first phase of adAPT will screen participants aged 5-16 years (inclusive) for~     islet-related autoantibodies who are the siblings or offspring of individuals diagnosed with~     T1D before the age of 25years in Scotland and England.~      There are four principle islet-related antibodies associated with T1D. The presence of two~     or more confers a 40% risk of developing T1D in five years. While the presence of none or~     one antibody carries a similar risk for developing T1D to the general population (1 in 500~     in 5years).~      It is anticipated that 5% of those screened will be identified as double-antibody positive,~     these participants will be invited to join the intervention phase of the study - randomised~     controlled trial (RCT). Up to 200 eligible subjects could be identified by screening with a~     minimum of 90 being enrolled into the RCT phase.~      adAPT is a proposed three stage project. The current protocol defines the screening phase,~     Stage 1 and seamless entry into Stage 2. Screening will identify children and young people~     at high risk of developing T1D and invite them to participate in Stage 1 which will involve~     a minimum of 4 months treatment with either metformin/placebo, however Stage1 treatment will~     run seamlessly into Stage 2. Stage 1/2 treatment will last up to 21 months (to accommodate~     15months screening, 4 months treatment and 2 months analysis). Post Stage1 analysis/ late~     Stage 2 participation will last up to 36 months (participants enrolled early into Stage 1~     will have the longest intervention).~      During the Stage1 participants will be tested on three occasions (baseline, month 1 and~     month 4) for metabolic response using a 5-point mixed meal tolerance test (MMTT). Testing~     will continue in Stage 1/2 with 3 visits further visits at months 8, 12, 18. Late Stage 2~     visits will occur on months 24, 30 & 36.~      Participants will be invited to continue into Stage 3, taking treatment up to 60 months post~     analysis of Stage 1 and associated protocol amendment and additional consent.~   "
13427|NCT02881515|"~     Excess dietary salt increases the risk for cardiovascular events, even in people that are~     not hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure~     and sympathetic nervous system responses to various perturbations and increases blood~     pressure variability. This proposal will examine the effects of low, medium, and high salt~     diets on cardiovascular reactivity and blood pressure variability.~   "
13428|NCT02881502|"~     Program： Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe~     Asthma Aim：The early prediction of severe asthma, early intervention on the disease, reduce~     the family and the national finance.~      design:This study is a single center randomized controlled trial designed by the Department~     of respiratory medicine, Xijing Hospital, as the main research unit.Compare the case~     group(severe asthma group and mild-and-moderate asthma group) and control group(healthy~     control group) by detecting the activity of MPO、NE、MMP-9 and ECP in the peripheral blood and~     the activity of HDAC2 in PBMCs of patients.~      case:60~      Case selection:~      Inclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was~     signed.~      Exclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to~     be combined with psychotropic medication.~   "
13429|NCT02881489|"~     The goal of this study is to investigate the safety and tolerability of autologous bone~     marrow-derived mesenchymal stem cells administration in the individuals with diagnosed~     amyotrophic lateral sclerosis.~   "
13430|NCT02881476|"~     The goal of this study is to investigate the safety and tolerability of allogeneic Wharton's~     jelly-derived mesenchymal stem cells administration in the individuals with diagnosed~     amyotrophic lateral sclerosis.~   "
13431|NCT02881463|"~     Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks~     such as rising from a chair. Therefore interventions aimed at improving muscle strength and~     sit-to-stand task performance are very important for these patients. The effect of exercise~     programs, including home exercise programs (HEP), on muscle strength, joint pain and~     function is well known and widely researched, yet not many studies have investigated the~     effect of an HEP on electromyographic activity (EMG) of muscles when performing everyday~     tasks, such as rising from and sitting on a chair. The aim of this study was to investigate~     effect of prehabilitation in women with severe knee joint OA scheduled for knee joint~     arthroplasty (TKA).~   "
13432|NCT02881450|"~     Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this~     study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January~     2012 with capture-recapture design using several independent sources of case~     identification.~   "
13433|NCT02881437|"~     Most immunodeficiencies are related to severe immunoglobulin deficiencies which require~     lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and~     severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or~     subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV~     infusions or have difficulties with venous access. No head-to-head data are available to~     directly compare HyQvia with conventional SCIG. However, SCIG is indicated for~     administration frequencies from daily up to every other week dosing while HyQvia is~     indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG~     trough level after switching from standard SCIG to every other week HyQvia and HyQvia every~     3-4 weeks~   "
13434|NCT02881424|"~     Background:~      Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic~     outcome relies on relapse prevention which seeks to identify high risk situations and~     individual's response to these situations especially the emotional response to social~     environment. Alcohol-dependence also induces cognitive impairments leading to social~     cognition impairments increasing the risk of relapse.~      Familiarity is a key process in social interactions: it induces the feeling of prior~     knowledge of a stimulus without remembering consciously its identity. Followed by a second~     process based on the contribution of contextual information (recollection) familiarity~     allows face recognition.~      Main aim:~      Study of familiarity for faces in alcohol-dependence~      Secondary objectives:~      Highlighting correlations between familiarity impairments and clinical outcomes~   "
13435|NCT02881411|"~     The main aims of this preliminary research are to determine if combined self-soft tissue~     therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a~     feasible and acceptable treatment approach for FMS. All participants on the six week FCSP~     will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group~     (FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome~     measurements at the start of the feasibility study, at six weeks and three months after~     completion.~      This feasibility study hypothesis is that the SST approach will be acceptable to FMS~     patients and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be~     beneficial. This feasibility study will inform a larger randomized controlled trial (RCT) on~     this combined treatment approach to FMS.~   "
19128|NCT02806895|"~     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate~     the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to~     obstructive sleep apnea.~   "
13436|NCT02881398|"~     The primary objective of this investigation was to assess the impact of new mobile health~     devices on health outcomes among patients with rheumatic and structural heart disease in a~     resource limited area. To achieve this aim the investigators utilized smartphone-connected~     devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and~     pocket-sized and handheld ultrasound. The main question asked in this investigation is if~     mobile health assessments accelerates medical-decision-making and if it shortens the time to~     definitive therapy.~   "
13437|NCT02881385|"~     Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer~     inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between~     humans and ventilators,making people uncomfortable and prolonging weaning time.Some~     ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it~     will make the transforming more synchrony with humans.Our prospective observational study~     will prove the superiority of the auto cycle function.~   "
13438|NCT02881372|"~     This is a single-center, prospective, pilot clinical trial in which children ages 5-17 years~     with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive~     oral desensitization with that specific food antigen, followed by reintroduction of that~     food into the diet.~   "
13439|NCT02881359|"~     This study will assess the effectiveness of commercially available LifeSeal® Kit as measured~     by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing~     low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal®~     will be offered to participate~   "
13440|NCT02881346|"~     This study aims to assess how the Enstilar® aerosol foam performs in daily real-life~     practice with regards to effectiveness and convenience of application to psoriasis plaques~     on body and extremities. In addition the profiles of patients prescribed Enstilar® will be~     described, and preceeding, concomitant and follow-up management will be mapped. The study~     will be conducted in about 100 dermatology clinics all over Germany,~   "
13441|NCT02881333|"~     Currently, for a patient with intellectual disability without a recognizable syndrome (most~     cases), the way to diagnosis is often long, tedious and expensive because different~     approaches are used one after the other to identify structural variants (duplications,~     deletions and other) and point mutations (sequencing of one or more candidate genes). The~     development of high-throughput sequencing techniques (next generation sequencing: NGS) has~     drastically increased the detection of point mutations offering the possibility to test a~     large number of genes simultaneously. NGS also shows a huge potential in detecting~     structural variants. The objective of this research is to assess the sensitivity of a~     simultaneous detection of point mutations and structural variants by NGS approaches. This~     would bring together in a single step the equivalent of performing an array-Comparative~     genomic hybridization (CGH) analysis plus performing a targeted sequencing of candidate~     genes. Investigators will compare two approaches for this simultaneous detection: a targeted~     enrichment of candidate genes coding regions using probes covering these regions associated~     with a backbone of genomic probes, an approach that could be implemented immediately in~     diagnostic at the hospital, and a whole genome sequencing (WGS), that is currently a too~     expensive tool for routine diagnosis but that should be the approach used in the future.~     Investigators will compare these two approaches to the traditional one: CGH array + WGS. The~     implementation of a one step strategy to detect both types of mutations (punctual and~     structural) would accelerate and improve the access of patients to a molecular diagnosis.~   "
13442|NCT02881320|"~     The primary objectives of this study are to evaluate the steady state pharmacokinetics (PK)~     for bictegravir (GS-9883) and confirm the dose of bictegravir/emtricitabine/tenofovir~     alafenamide (B/F/TAF) fixed-dose combination (FDC) in HIV-1 infected, virologically~     suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age). This~     study will also evaluate the safety and tolerability of B/F/TAF FDC through Week 24 in HIV-1~     infected, virologically suppressed adolescents and children.~   "
13443|NCT02881307|"~     The purpose of this research study is to evaluate if a weight loss intervention will improve~     your rheumatoid arthritis disease activity.~   "
13444|NCT02881294|"~     The purpose of the study is to investigate the effect of Food, Gender, and Age on the~     Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects~   "
13445|NCT02881281|"~     Adolescence is the most important period of growth for humans. The conflict and disagreement~     which exists within family relationships will affect the children behaviors. Family~     relationships are the cause of many problems in adolescents, to develop a training program~     on problem-solving skills for adolescent girls to change their relationship with their~     parents.~   "
13446|NCT02881268|"~     Open-label, non-randomized, prospective, single center, observational, translational study~   "
13447|NCT02881255|"~     The purpose of the study is to compare standard, single chamber transvenous ICD to~     sub-cutaneous ICD in occurrence of perioperative and long term device related complications~     and failed appropriate clinical shocks and arrhythmic death.~   "
13448|NCT02881242|"~     This phase II trial studies how well trametinib works in treating patients with~     hormone-resistant prostate cancer that is growing or getting worse and has spread to other~     parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
13449|NCT02881229|"~     This study aims to develop a clinical database of patients presenting with vulvar complaints~     in order to comprehensively assess the presentation and current trends in management of~     vulvar disease.~   "
13450|NCT02881216|"~     This study sought to compare procedural performance of a new coronary stent generation, that~     is already available in Germany, with hitherto established current drug-eluting stents.~   "
13451|NCT02881203|"~     This study investigates the Breathe Well device to test whether it is superior to the~     existing treatment standard of the Varian Realtime Position Management (RPM) system in~     assisting patients with deep inspiration breath hold.~   "
13452|NCT02881190|"~     A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC~     administered subcutaneously to subjects with HER2-positive malignant in advanced malignant~     solid tumors.~   "
13784|NCT02876861|"~     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin~     (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the~     overall survival for high-grade upper tract urothelial carcinoma.~   "
13453|NCT02881177|"~     The purpose of this pilot study is to determine the tolerability, feasibility, and~     preliminary effectiveness of intranasal oxytocin administration prior to motivational~     enhancement group therapy sessions on laboratory-based measures of addiction, social~     connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with~     men (MSM). The investigators propose a randomized, double-blind, study of intranasal~     oxytocin versus placebo 40 IU prior to each of three Motivational Enhancement Group Therapy~     (MEGT) sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use~     disorder.~   "
13454|NCT02881164|"~     To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic~     response and satiety in subjects with type 2 diabetes mellitus under intensive insulin~     therapy.~   "
13455|NCT02881151|"~     This study involves the treatment of cognitive impairment secondary to moderate to severe~     brain injury using central thalamic deep brain stimulation. Although all patients will~     receive stimulation continuously through an implanted pacemaker-like device, half of the~     patients will have the device deactivated during a blinded assessment phase. The device will~     be reactivated following this assessment and patients will have the option to continue~     stimulation in an open-label continuation.~   "
13456|NCT02881138|"~     A tolerance, safety and pharmacokinetic ascending dose Phase I Study of RC48-ADC~     Administered Subcutaneously to Subjects With HER2-Positive malignant in Advanced Malignant~     solid Tumors.~   "
13457|NCT02881125|"~     This phase I trial studies the side effects and best dose of nortriptyline hydrochloride~     when given together with paclitaxel in treating patients with small cell carcinoma that has~     come back. Nortriptyline hydrochloride, may help disrupt survival signals and cause cancer~     cell death. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving nortriptyline hydrochloride and paclitaxel may work~     better in treating patients with small cell carcinoma.~   "
13458|NCT02881112|"~     The study is an open-label, non-controlled study of the safety and effectiveness of~     investigator determined Provant therapy in subjects with pain and/or edema from various pain~     etiologies. Information collected in the study will be entered into a registry database.~   "
13459|NCT02881099|"~     Prospective observational study of Parkinson's disease with repeat clinical assessment and~     biobanking of blood samples.~   "
13460|NCT02881086|"~     A phase IV study with the primary goal to optimize therapy of adult patients with acute~     lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric~     based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual~     disease (MRD) based individualised and intensified therapy. Study will further evaluate the~     role of asparaginase intensification, the extended use of rituximab and the use of~     nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore~     two randomisations will focus on the role of central nervous system (CNS) irradiation in~     combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL~     and the role of SCT in high-risk patients with molecular complete remission. Finally a new,~     dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL~     positive ALL.~   "
13461|NCT02881073|"~     The primary aim is to establish the effectiveness of plasma PlGF measurement in reducing~     maternal morbidity (with assessment of perinatal safety in parallel) in women presenting~     with suspected pre-eclampsia prior to 37 weeks' gestation.~      The long term aim is to demonstrate that knowledge of PlGF measurement enables appropriate~     stratification of the antenatal management of women presenting with suspected pre-eclampsia,~     such that those at highest risk receive greater surveillance with a decrease in maternal~     adverse outcomes, and those at lower risk can be managed without unnecessary admission and~     other interventions, such that the results would influence international clinical practice~     in antenatal patient healthcare~   "
13462|NCT02881060|"~     Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is~     used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair~     the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the~     dual hormone treatment in preventing hypoglycaemia.~      The purpose of this study is to determine, whether ethanol influences the glucose response~     to subcutaneous glucagon during mild hypoglycaemia.~      The investigators hypothesize that prior evening ethanol consumption does not reduce the~     effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol~     consumption.~      The study aims:~        1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to~          restore plasma glucose after an episode of mild hypoglycemia.~        2. To determine the late effects of ethanol on the counter-regulatory hormones and~          hypoglycaemia awareness during mild hypoglycaemia~      A double-blinded placebo-controlled study will be conducted. Participants will serve as~     their own controls. Eligible participants will after an informed consent complete two study~     visits, one with and one without ethanol consumption, in a random order. On each study~     visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a~     meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous~     injection of 100 mcg glucagon is administered. Two hours later a second bolus is~     administered.~   "
13463|NCT02881047|"~     Graft versus host disease (GVHD) is a common complication of allogeneic stem cell~     transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced~     sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once~     present, there are few therapeutic options. We will treat sclerosis and limb contractures~     with an ablative fractional laser, a device FDA-approved for scar treatment. This approach~     has successfully treated contracturesdue to burn scars.~   "
13464|NCT02881034|"~     Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin~     than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure~     the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal~     function.~   "
13626|NCT02878915|"~     Using ultrasound to guide vascular catheterism in children is highly recommended for central~     venous access. It has been proven that central venous line is inserted faster, with fewer~     attempts and complications. Its interest in central arterial line insertion is less obvious.~     It seems to have benefits in adults, both for radial and femoral arterial insertion. But~     there is no study assessing the interest of ultrasound guided arterial puncture in~     children,.~   "
13465|NCT02881021|"~     Background: Rotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain,~     resulting in considerable losses to society and public coffers. Muscle imbalance and~     inadequate sensorimotor control are deficits often associated to RCTe. Kinesiotaping (KT)~     has been widely used for rehabilitation of RCTe. While previous studies have examined the~     effects of KT on shoulder injuries only in short-term and as an isolated method of~     treatment, no published study has addressed its mid- and long-term effects when combined~     with a rehabilitation program (RP) for patients with RCTe (as used in clinics). The main~     objective of this study will be to assess the effectiveness of therapeutic KT application~     added into an RP in reducing pain and disabilities in patients with RCTe. Secondary~     objectives will cover underlying factors related to shoulder control, such as muscular~     activity, acromiohumeral distance (AHD), and range of motion (ROM).~      Methods/Study design: A single-blind, randomized controlled trial will be conducted.~     Fifty-two patients, randomly allocated to one of two groups (KT or no-KT), will receive 10~     physiotherapy sessions over six weeks. The KT-group will receive therapeutic KT added to the~     RP, whereas no-KT group will receive only the RP. Primary outcomes will be symptoms and~     functional limitations assessed by Disabilities of the Arm, Shoulder, and Hand (DASH)~     questionnaire. Measurements will be taken at baseline, week-3, week-6, week-12 and 6-month.~     Secondary outcomes will include shoulder active ROM, AHD at rest and at 60º of abduction,~     and shoulder muscle activation during arm elevation. The added effects of KT will be~     assessed through 2-way ANOVA for repeated measures.~      Discussion: Investigations with a high level of evidence are needed to determine scientific~     evidence-based concerning the efficacy of KT for the rehabilitation of individuals with~     RCTe. This RCT will be the first to assess the effectiveness of KT added into a conventional~     RP for patients with RCTe, addressing underlying factors that could explain the possible~     benefits of this method, in a mid- and long-term. Results may contribute to build solid~     evidence on the addition of KT in a physiotherapy intervention for this population.~   "
13466|NCT02881008|"~     Randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in~     patients with HBeAg negative chronic hepatitis B.~   "
13467|NCT02880995|"~     The first purpose of this study is to determine if dopamine synthesis capacity is~     significantly lower in treatment non-responders from illness onset relative to treatment~     responders. And the second purpose of this study is to determine the potential of [18~     fluorine(F)]-DOPA to be used to predict treatment response to antipsychotic treatment in~     first episode psychosis.~   "
13468|NCT02880982|"~     The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised~     placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape~     Town Metropolitan Municipality, Western Cape Province, Republic of South Africa.~      The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg~     (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent~     tuberculosis infection (LTBI) in Cape Town primary schoolchildren.~      Statistical analysis will be performed on an intention-to-treat basis to compare acquisition~     of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis~     will be logistic regression with presence/absence of LTBI at follow-up as the outcome,~     adjusted for a random effect of school of attendance.~   "
13469|NCT02880969|"~     End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of~     graft availability. Being under dialysis requires a recourse to pluri-weekly magazine of~     health care system, impacting negatively patient's quality of life (QoL) and their~     entourage, at a psychological, physical and social level.~      Although further studies have assessed QoL in ESRD grafted children, a lack of information~     exists concerning patients' QoL during dialysis before graft. In addition, some limits could~     be listed, these studies have small samples, 50 patients at all, and only clinical~     determinants are studied. A larger clinical research assessing children's QoL studying~     individual and populational factors is necessary.~      The aim of the study is to assess the influence of individual and populational determinants~     on children's QoL with ESRD, treated by dialysis.~      Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be~     realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders,~     ii) younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one~     of the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and~     the 31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be~     re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be~     signed by patient and their mainly caregiver.~      Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and~     VSP-A. In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment~     (IPPA), optimism (Y-LOT) measures and socio-demographic data will be collected.~     Self-administered questionnaires will be used for assessing caregivers' Qol (SF36), anxiety~     (STAI-Y), coping (BriefCope situational format), health care system satisfaction (Care~     quality scale) and burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by~     caregivers will be assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition,~     socio-demographic data, urban environment and economic environment will be collected.~     Clinical data will be collected by health professionals.~      Results expected A sample of 136 children with ESRD is expected for identifying individual~     and populational factors which could influence chronic dialysed children QoL, in order to~     propose adjustments to optimize these patients quality of life.~   "
13470|NCT02880956|"~     This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early~     Alzheimer's Disease.~   "
13471|NCT02880943|"~     This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum~     tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer~     patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.~   "
13472|NCT02880930|"~     Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances~     the immune system and may help protect against chest infections that can cause wheezing~     illness or worsen asthma symptoms. The Department of Health recommends a dose of 10~     micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However,~     many studies have reported that this dose is not enough to raise plasma 25(OH)D~     concentration to the levels most likely to prevent against worsening of asthma symptoms.~     Such studies suggest that 25 micrograms of vitamin D/day. This dose is safe but its effects~     on vitamin D blood levels have not yet been specifically tested in children with~     asthma/wheeze. This study is designed to determine the optimal oral daily vitamin D~     supplementation dose to treat vitamin D deficiency in children with asthma or preschool~     wheeze. Over the 6-month course of the study, participants will meet with the study team~     four times in clinic or in their own home and will be contacted by telephone five times.~     Children will be asked to give a drop of blood via a fingerprick to test their vitamin D~     level and a sample of nasal epithelial lining fluid for measurement of inflammatory markers~     on three separate occasions.~   "
13509|NCT02880449|"~     The aim of the project is pilot an intervention to promote physical activity (PA) among~     older women.~      Participants will be women aged ≥50 years attending an identified community centre situated~     in a socioeconomically deprived area of Belfast. The intervention consists of education,~     social support and information on local opportunities for physical activity (PA), based on~     Social Practice Theory. A stepped wedge design shall be used. The intervention was developed~     using findings from a literature review, systematic review and interviews with stakeholders.~     Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and~     qualitative interviews.~   "
13638|NCT02878759|"~     The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis~     and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic~     disease.~   "
13473|NCT02880917|"~     Chronic pain represents an important health problem responsible for decreases in quality of~     life, and is associated with great negative impact in society and economy. In many cases,~     its treatment does not reach therapeutic success causing health professionals and patients~     dissatisfaction. Chronic pain is also associated with somatization, hopelessness and~     catastrophizing thinking. These information processing includes sensorial, emotional and~     cognitive-appraisal thinking, which manifests the working of neural networks at cortical and~     sub-cortical levels. Attention is a central aspect in the processing of pain modulation.~     Like in addictions (e.g. smoking, alcohol), chronic pain may debut with displacement in the~     focus of attention and alterations in the sensorial processing in the incentive-motivation~     tests. Considering that other studies have indicated that experimental and clinical pain is~     capable of modulating cognitive activities such as attention and expectation, in this study~     the investigators will test the hypothesis that the presence of pain will reduce the~     reaction time to visual stimuli related to pain/suffering, and this bias could be modified~     using transcranial direct current stimulation (tDCS).~   "
13474|NCT02880904|"~     The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).~   "
13475|NCT02880891|"~     The microthreaded and platform switched implants could control the stress in the suitable~     range. The splint would disturb the function. So it is necessary to know whether the~     splinted single-unit crowns is fit for the adjacent multi-implants.~      Outcome variables: Splinted single-unit crowns on one side implants and non-splinted~     single-unit crowns on the other side Materials and method: 80-100 consecutive implants in at~     least 20 patients would be included for implant- supported restorations in the posterior~     maxilla or mandibular. All patients would be in general good health. For every patient, the~     same posterior teeth had lost on both sides for more than 6 months. All patients were~     treated by the same qualified surgeon.~      Prosthetics procedure would be performed by an experienced prosthodontist. The two sides~     were allocated to the test or the control group according to the predefined~     computer-generated randomization table. Clinical evaluations and radiographic analysis were~     performed by an oral and maxillofacial radiologist who was not aware of the type of~     Prosthetics technique that was used.~   "
13476|NCT02880878|"~     This is a multicenter, randomized, adaptive clinical trial comparing standard medical~     management to early (<24 hours) surgical hematoma evacuation using minimally invasive~     parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial~     intracerebral hemorrhage.~   "
13477|NCT02880865|"~     This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine~     (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not~     adversely affect immunogenicity or safety.~   "
13478|NCT02880852|"~     In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly~     intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will~     evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of~     belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to~     receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the~     treatment of SLE. Subjects will be followed for 84 days after the administration of drug.~   "
13479|NCT02880839|"~     To compare the internal fixation results of three pedicle screw implantation methods and~     investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.~   "
13480|NCT02880826|"~     The tools to measure safety culture (CS) have recently become available. No study has~     focused on the measure in France, apart from pilot studies. intensive services are~     particularly at risk of serious adverse events occurred (SAEs). Patients who are~     hospitalized are in fact fragile and precarious clinical condition requires rapid decision~     taken often. Diagnostic or therapeutic strategies have report risk-benefit narrow. They~     may well be complicated by EIG.Safety of care is a priority in the field of health in~     general, and especially in intensive care. CS measure in this context seems particularly~     relevant.~      The main objective is to describe the CS intensive care units in France. The study will~     explore the development of the CS level for the units investigated.~      This study will also describe the main features of RMM practiced in intensive care units in~     France.~   "
13481|NCT02880813|"~     This pilot study will look at whether infusion of nutrients into the duodenum or into the~     stomach will result in:~        1. decrease in hunger and food intake~        2. greater weight loss due to loss of body fat with reductions in waist and hip~          circumferences~        3. improvements in other weight-related health conditions such as diabetes, high blood~          pressure, and high blood triglycerides. Inclusion criteria: 25-60 years old with a BMI~          of ≥ 30≤55 kg/m2.~      Subjects (16 individuals) will be in the study for 12 days and have a dobhoff tube placed at~     the start of the study. Subjects will visit MCRU daily for 12 days where meals will be~     provided, and where anthropometric measures, blood work during an oral mixed meal tolerance~     test (study start and study end), and surveys will be completed. The dobhoff tube will~     remain in place until the end of the study.~   "
13482|NCT02880800|"~     The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus~     the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia)~     on an as needed basis within a well defined fast track protocol that includes multimodal~     analgesia for patients who are undergoing elective primary knee replacement surgery. The~     investigators assumed that with the multimodal analgesia regimen without the use of IVPCA~     will demonstrate decreased consumption of postoperative opioids, reduced incidence of~     opioids related side effects and decreased length of stay in the hospital.~   "
13483|NCT02880787|"~     The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery~     from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and~     pediatric population.~      Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:~        -  the onset of clinical action of curare: suppression of the first response of train of~          four monitoring (T1) of 95% initial value~        -  the duration of clinical action of curare: recovery of the first response of train of~          four monitoring (T1) to 25% initial value~        -  recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of~          four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)~        -  complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.~   "
13484|NCT02880774|"~     Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex~     and multifactorial pathology, where functional and pathological changes commit~     temporomandibuar articulation, masticatory muscles, and other associated structures. In the~     light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment,~     including physical therapy with the use of manual features, has been excelling. Objective:~     The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on~     the mandibular movement and lateralidades, through the three-dimensional kinematics in~     subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and~     functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment~     sessions. Method: This is a clinical trial randomised, placebo-controlled and blind,~     designed to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned~     ultrasound). Individuals will be randomised controlled trials and allocated into two groups:~     Group A (intervention) and Group B (placebo) and evaluated by the Research Diagnostic~     Criteria for Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale~     of Pain (END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional~     Scale and Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will~     be the primary outcome and will be quantified by three-dimensional kinematic analysis. The~     pain, Functionality and quality of life will be the secondary outcomes. Initially the~     distribution of data will be checked by the Shapiro-Wilk test. In comparisons between the~     groups, if the data present normal distribution will be used a repeated measures ANOVA to~     two factors, being these: Group (intervention and placebo) and treatment (pre and~     post-intervention), with Bonferrone correction. If the data do not show normal distribution,~     a logarithmic function is used to correct striping. As level of significance will be used p~     < 0.05.~   "
13485|NCT02880761|"~     A cohort including more than 100 maintenance hemodialysis patients will be followed up~     according to a certain Following-up System of Native Arteriovenous Fistulae (AVF)~     prospectively. The assessment results of the Following-up System of AVF help the physicians~     make decisions of AVF surgery and puncture methods. The results of this study would identify~     the effect of the system on survival of AVF. Other 100 hemodialysis patients from other~     centers will be treated by routine protocol and compared to the experiment goup.~   "
13486|NCT02880748|"~     Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number~     of adenomas may be missed in patients with polyps found by previous colonoscopy. And water~     exchange (WE) method may increase the detection of missed adenoma compared with traditional~     air insufflation (AI) colonoscopy. The investigators aim to investigate whether water~     exchange colonoscopy method, compared with air insufflation method, can improve the~     detection of missed adenomas in patients undergoing selective polypectomy.~   "
13487|NCT02880735|"~     It has been suggested that patients with Myotonic Dystrophy type 1 have primary altered~     ventilatory response to chemical stimuli and chronic hypoventilation is related not always~     to muscle weakness. Also, it is known that Non Invasive Mechanical Ventilation can improve~     ventilatory response to chemical stimuli, especially to hypercapnia.~      This study evaluates the effect of Non Invasive Mechanical Ventilation on ventilatory~     response in patients with Type 1 Myotonic Dystrophy, the ventilatory response to chemical~     stimuli will be measured before and after mechanical ventilation in patients with myotonic~     dystrophy type 1.~   "
13488|NCT02880722|"~     Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable~     bowel syndrome are essential in order to investigate natural disease course and potential~     treatment options aimed at symptom improvement, since biological markers are currently~     unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week~     questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an~     electronic questioning method characterized by random and repeated, momentary assessments in~     the subject's current state and environment, might overcome these limitations. Aim of this~     study is to validate an IBS-specific electronic patient-reported outcome measure, based on~     the Experience Sampling Method-principle, for symptom assessment in IBS.~   "
13489|NCT02880709|"~     Major weight loss and taste changes are well documented in patients with hematological~     cancer during chemotherapy. It has previously been documented, that such patients have~     preferences for much umami, a little sweet, sour and salt, and no bitter. The purpose of the~     study was to convert these results into real diets. Patients participated in two sensory~     pilot studies (n=10), where dishes were tested for preferences before and after~     chemotherapy. From these results four dishes were selected and tested on 32 patients in 30~     days in a cross-over design. The diets resulted in a beneficial and statistical significant~     difference in weight development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention~     period and -2.8 ± 5.2 kg (-4%) in the control period. This difference persisted after~     sensitivity analysis (± 10%) p= 0.005. However, the nutritional intake was still low in both~     periods, and the treatment with cytarabin turned out to be a major confounder as dosage was~     significantly higher in the control period.~   "
13490|NCT02880696|"~     A key function of our brain is to identify temporal structures in the environment and use~     them to form expectations. These expectations allow us to plan and organize our behavior~     towards changes in the environment, and optimize the use of our attentional and motor~     resources. They also allow us to establish harmonious social interactions, coordinating us~     with our interlocutor during an exchange. Our ability to form temporal expectations seems to~     emerge very early but the development of this process is unknown. We only know that a set of~     basic skills, probably related to that ability, are present from birth. This suggests that~     temporal processing capabilities emerge during the prenatal period, but this has not been~     studied. The objective of this project is to study preterm infants brain's ability to~     process the intervals between stimuli and to form expectations on that basis.~   "
13491|NCT02880683|"~     A single-center feasibility study in patients undergoing cardiac catheterization, to~     investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve~     stimulation.~   "
13492|NCT02880670|"~     This is an open-label, single-dose, study in healthy males. The primary objective is to~     assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral~     dose of radiolabeled BMS-986142 in healthy male subjects.~   "
13493|NCT02880657|"~     The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation~     in physical condition improvements of healthy subjects, in comparison to a placebo.~   "
13494|NCT02880644|"~     In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and~     safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in~     United States and GALILEO study performed in Europe and Asia/Pacific.~      With the project of Hermes Study, the first observational study conducted in France in~     patients with CRVO and treated with aflibercept, we would like to evaluate in real life the~     monitoring and the use of Aflibercept. The primary objective of this study will also be~     based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal~     perfusion will be particularly evaluated by using ultra wide field angiography technology.~   "
13497|NCT02880605|"~     Coronary revascularization (CR) is increasing rapidly in China and varies significantly in~     proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China.~     Recently, National Center for Cardiovascular Disease organized experts to release Chinese~     version appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed~     at regulating indications of CR. The criteria is considered to contribute to clinical~     practices, quality assessment and health insurance policy, however, the validation of C-AUC~     is unknown.~      Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center~     prospective registry. The investigators will recruit 4000 patients undergoing elective~     coronary angiography with positive outcome consecutively and collect baseline information.~     Sequently, one-year follow up will be done to collect the prognose, including death,~     rehospitalization, medicine, medical compliance and life quality etc. One hand, the~     investigators will compare the outcomes between different therapies in the same indications~     according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators~     will evaluate the rationality of CAD therapy in Beijing by C-AUC.~   "
13498|NCT02880592|"~     This is a multi-center, randomized controlled trial designed to evaluate the use of fresh~     hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of~     fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs~     compared to SOC alone.~   "
13499|NCT02880579|"~     The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and~     appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency~     and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral~     infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It~     therefore remains a significant therapeutic challenge, especially for patients with~     against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty~     years of mechanical devices have been developed to remove, as quickly as possible, the cause~     of intracranial arterial occlusion and allow restoration of blood flow before brain damage~     is irreversible.~      NTF The protocol is part of the evaluation process of our clinical practices recommended by~     the National Health Authority (HAS), in the specific context of mechanical thrombectomy~     performed in French centers of interventional neuroradiology working with neurovascular~     units (A V).~   "
13500|NCT02880566|"~     Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp~     blocks on hemodynamic stability and opioid consumption during and after craniotomy.~   "
13501|NCT02880553|"~     The World Health Organization International Classification of Functioning, Disability and~     Health has shown that the environment can play a major role in patients' disability, and~     hence in their quality of life. This study considers social dimensions of quality of life,~     particularly family as well as social and professional networks.~   "
13502|NCT02880540|"~     Obesity represents one of the most important public health issues according to the World~     Health Organization and it has reached epidemic proportions globally. The prevalence of~     childhood obesity has rapidly increased over the past decade and is associated with multiple~     co-morbid disease states . It is estimated that approximately 15.5% of children and~     adolescents are obese with a body mass index of ≥95th percentile for age . This not only~     poses health concerns for the patient, but also places increased demands on our healthcare~     system that is already overwhelmed by burgeoning costs. Moreover, obese children and~     adolescents who maintain excessive weight as adults are predisposed to cardiovascular~     disease and premature death.~      In carefully selected patients who have failed to lose weight by diet and exercise,~     bariatric surgery provides an option to obtaining a healthy weight.~      It is increasingly becoming an attractive option, with the number of adolescents undergoing~     bariatric surgery in the United States tripling between 2000 and 2003.~      Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,~     which presents unique challenges to the anesthesiologist managing their perioperative care .~     Bariatric surgery in obese adolescents may be associated with significant postoperative~     pain. Potent intravenous opioids such as fentanyl and morphine are at the mainstay of~     perioperative pain management. Unfortunately, respiratory depression and airway obstruction~     can often occur following administration of opioids in obese patients . This makes providing~     a safe analgesic regimen difficult during the perioperative setting. As opioids can be~     associated with respiratory depression and upper airway obstruction, surgeons and~     anesthesiologists alike must reconcile the adequacy of pain control with the risk of~     respiratory complications after surgery in obese adolescents.~   "
13503|NCT02880527|"~     Polymyositis and dermatomyositis are characterized by the association to a myopathic~     syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an~     important factor of morbidity and mortality in these patients. At present, studies that~     evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly~     recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis~     has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic~     criteria of Bohan and Peter). However, previous works are old and retrospective; above all,~     they have almost always been performed (90% of cases) from cases reported to the hospital,~     leading to selection bias and an underestimate of the true prevalence of polymyositis /~     dermatomyositis in the general population.~      Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based~     on the population of Normandy.~   "
13504|NCT02880514|"~     A prospective, randomized, single-blind, intra-patient controlled, multicenter study. Study~     subjects will undergo implant placement on one side following in-office balloon dilation,~     while the contralateral side serves as a control.~   "
13505|NCT02880501|"~     Minimally invasive PFNA fixation for the treatment of intertrochanteric femoral fracture~     will be used in 20 patients within 2 years to objectively validate the safety and~     effectiveness of PFNA in the treatment of fracture of long tube-like bone.~   "
13506|NCT02880488|"~     The validation of a French questionnaire is very important to assess rigorously and~     objectively the impact of the treatments of strabismus and amblyopia on children quality of~     life.~   "
13507|NCT02880475|"~     This is an open-label, randomized, single-dose, parallel group study. The objectives of this~     study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN)~     prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese~     patients with moderate to severe chronic non-malignant pain.~   "
13508|NCT02880462|"~     The goal of the study is to investigate whether adding different doses of sulforaphane will~     benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.~      This study will compare the sulforaphane with placebo. There is a thirty percent change~     (less than half) of receiving the placebo. The purpose of including placebo is to judge if~     the outcome is related to the study medication rather than other reasons.~   "
13510|NCT02880436|"~     Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol~     levels and diabetes there are also acute factors potentially triggering acute coronary~     events. The impact of various substances and air pollution are described.~      Particulate matter, especially with small particle size (<2.5µm) has been shown to have a~     positive correlation with myocardial infarctions. However, other studies failed to show this~     correlation.~      With respect to nitric oxydes the majority of published studies detected a significant~     correlation with myocardial infarction, too, although a highly ranked publication failed to~     show the same result. In addition data on the impact of sulfur dioxide and carbon monoxide~     concentration on cardiac events is very heterogeneous.~      Published data indicates additive effects of age and other epidemiological variables~     suggesting the need of a multivariate analysis.~      The rationale of the study is to test if the above mentioned air pollution factors have a~     significant and independent impact on the incidence of myocardial infarctions~   "
13511|NCT02880423|"~     Based on the accumulated literature, salpingectomy may significantly reduce the risk for~     ovarian cancer. If investigators can prove that there is no increase in surgical~     complications and morbidity during salpingectomy in CS, compared to tubal ligation,~     investigators can recommend for women who are interested in sterilization- salpingectomy~     during cesarean section .~   "
13512|NCT02880410|"~     Multicenter, open-label, prospective designed study to characterize the performance of brain~     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in~     combination with standard of care radiation therapy and temozolomide for the treatment of~     newly diagnosed glioblastomas (GBM).~   "
13513|NCT02880397|"~     A single-center, randomized controlled clinical trial was done to assess the periodontal~     status of the individuals and the presence of red complex microorganisms (RCM) such as~     Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival~     tissues of periodontal pockets at baseline followed by the application of mangostana gel as~     an adjunct to scaling and root planing. The periodontal parameters and RCM were again~     assessed at 3rd month and compared with the placebo group.~   "
13514|NCT02880384|"~     Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using~     current diagnostic tests to the number detected using the BioFire Diagnostics~     investigational polymerase chain reaction (PCR) platform.~   "
13515|NCT02880371|"~     This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose~     (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab~     in adult patients with selected advanced solid tumors (Part A), to assess the~     pharmacodynamic effects of the combination and to describe the preliminary antitumor~     activity of the combination in patients with advanced unresectable/metastatic melanoma (Part~     B), and to estimate the efficacy of the combination in patients with PD-L1-positive NSCLC~     (Part C).~   "
13516|NCT02880358|"~     EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological,~     observational, prospective and multicenter study. This study includes at first an exhaustive~     recording of the cases on a geographic area at East of France, then the recorded patients~     are followed up in a cohort at least 3 years. This study follows the experiences of the~     EPICAL study led by our team.~      Main objective: To describe the characteristics of the patients affected by acute heart~     failure and to identify prognostic factors, in particular related to care. More exactly :~        -  To describe the sociodemographic, clinical, biological and therapeutic characteristics~          of the patients presenting an acute heart failure during hospitalisation and living at~          East of France ;~        -  To study the short and medium-term morbi-mortality of these patients, and identify the~          main factors determining the prognosis for survival ;~        -  To evaluate the prognostic impact of the intra and extra-hospital care ;~        -  To identify the evolution of the care's practices of the decompensated heart failure~          since the EPICAL study (15 years) and their influence on the prognosis of the disease.~      Secondary objective: to constitute a biological collection of serum, plasma and urine of~     patients' sample presenting an acute heart failure.~   "
13517|NCT02880345|"~     This is a pilot study of a fixed dose of Pembrolizumab in combination with two different~     regimens of hypofractionated radiation. It is designed to demonstrate the activity and~     safety of the combination treatment in advanced urothelial cancer patients with prior~     exposure to PD-1 inhibitors.~   "
13518|NCT02880332|"~     The primary scientific objective of the study entails examining whether altered endogenous~     pain inhibition is present in children with functional abdominal pain (FAP) and irritable~     bowel syndrome (IBS) compared with healthy controls (Part 1). A secondary objective implies~     examining whether pediatric pain neuroscience education (PNE) is able to improve pain~     catastrophizing, pain-related fear, pain intensity (including symptoms and indices of~     central sensitization) and pain-related functional disability in children with FAP or IBS~     (Part 2).~   "
13519|NCT02880319|"~     This research study is studying a form of radiation therapy called stereotactic body~     radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or~     other bone~   "
13520|NCT02880306|"~     Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk~     of developing malignancies, while studies examining the association between hepatocellular~     carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of~     HCC between participants with and without RA.~   "
13521|NCT02880293|"~     This study will test whether half matched donors with favorable KIR genes will reduce the~     risk of cancer recurring after transplant.~   "
13522|NCT02880280|"~     Observe the therapeutic efficacy of human menopausal gonadotropin combining with human~     chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.~   "
13523|NCT02879227|"~     Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.~   "
13524|NCT02879214|"~     The purpose of this study is to determine the feasibility of minimal invasive surgical~     resection through simultaneously integrated dose escalation given concurrently with~     chemotherapy for locally advanced squamous cell cervical cancer.~   "
13525|NCT02879201|"~     The investigators conducted a comparison trial between SLED and CRRT in critically ill~     patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome~     were recovery of renal function, complications during therapy and duration of~     hospitalization.~   "
13529|NCT02879149|"~     The objective of this long-term study is to evaluate the long term effectiveness and safety~     of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects~     originally treated under Protocol BMTI-2006-01.~      Subjects will be asked to consent and return to provide long-term follow-up data at or after~     60 months (5 years) have elapsed since their original surgery as a subject in protocol~     BMTI-2006-01.~      STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained~     and remains comparable to that of autologous bone graft over long-term subject follow-up.~      REGULATORY PHASE: Post-approval study~   "
13530|NCT02879136|"~     Gait and balance problems are a significant source of disability in patients with Parkinson~     disease. Physical therapy remains one of the main treatments. On the other hand some~     medications, such as methyphenidate and atomoxetine, have been tried with promising results.~     The outcomes in gait and balance in Parkinson disease after a combination of physical~     therapy and the medications mentioned above have not been explored yet. The investigators~     want to evaluate whether the addition of medication, either low dose of methylphenidate or~     atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson~     disease more than physical therapy alone. The investigators propose a pilot, single center,~     rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat~     analysis.~   "
13531|NCT02879123|"~     This trial aims at collecting standardized data concerning the early neurological clinical~     recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.~      Although this outcome is a major issue of patients' prognosis, it is rarely collected at~     this stage of their follow-up.~   "
13532|NCT02879110|"~     In this proposed study, the investigators will evaluate the the efficacy, safety and related~     mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will~     recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or~     placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety~     assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims~     are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other~     behavioral problems and adaptive behaviors. Biological samples also will be collected, and~     stored to research related mechanisms.~   "
13533|NCT02879097|"~     The purpose of this study is to determine whether CBT124 and Avastin® are comparable in~     terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124~     matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).~   "
13534|NCT02880254|"~     Kurbo is a health and fitness app that is targeted toward the pediatric population. It~     utilizes games and activities to educate children about healthy eating, portion control/size~     and exercise. It allows for food tracking by using servings of macronutrients and food~     groups and sets goals for achieving a healthy BMI through modification of diet intake. In~     addition to being created solely for children and adolescents, a unique feature of this app~     is an option to speak with a personal health coach on a regular basis to obtain feedback,~     advice and encouragement. Studies suggest that weight loss outcomes are best with more~     frequent contact hours but most weight loss clinics, including ours, are not equipped to~     meet with patients on a weekly basis or even monthly basis. The personal coaching aspect of~     Kurbo is expected to improve outcomes by increasing user access to feedback and advice.~      The purpose of this pilot study is to assess the feasibility, compliance with and effects of~     a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents~     in a pediatric weight management program. The investigators will assess the impact of the~     app as an adjunct to current weight management therapy, both with and without the personal~     health coach (PHC) option.~   "
13535|NCT02880241|"~     The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed~     activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced~     Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax~     malaria in patients, both over 14 and 28 days. Additional aims are to characterise the~     safety of MMV390048 in patients. Patient safety will be monitored for up to 35 days~     post-dose including pharmacokinetic assessments. The study will investigate descending~     single doses of MMV390048 in response to results obtained in the first cohort/dose in each~     malaria sub-type. The results of this trial will identify active, well-tolerated doses for~     investigation in combination with a partner drug within a Phase IIb clinical trial.~   "
13536|NCT02880228|"~     This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in~     treating patients with newly diagnosed multiple myeloma that are eligible for stem cell~     transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with~     multiple myeloma.~   "
13537|NCT02880215|"~     Although negatively biased attention has a central theoretical and empirical role in the~     maintenance of depression, there are few behavioral treatments that successfully target and~     improve this deficit. The current proposal builds upon prior work and aims to further~     develop an attention bias modification intervention. The investigators propose to develop a~     highly specific intervention that directly targets negative attention bias and the~     neurobiology that supports it, using cutting-edge cognitive neuroscience to inform treatment~     development and improve quality of life of patients whose psychopathology is maintained by~     negative attention bias.~   "
13538|NCT02880202|"~     This is a pilot study to evaluate the impact of massage therapy in hospice patients.~   "
13539|NCT02880189|"~     This study is designed to investigate the impact of weight loss achieved with the IGB on~     NASH with early fibrosis in a select cohort of patients with obesity preselected to have a~     high pre-test probability of having NASH with early fibrosis based on MRE-Hepatogram. In~     addition, this study will explore potential non-invasive imaging criteria for NASH and early~     fibrosis using EUS-Elastography.~   "
13653|NCT02878564|"~     The aim of this study is to assess the impact of Schistosoma mansoni infection and its~     treatment on genital immunology and HIV susceptibility in Ugandan women.~   "
44858|NCT02469857|"~     The purpose of this study is to determine whether AB103 is safe and effective in the~     treatment of patients with necrotizing soft tissue infections receiving standard of care~     therapy.~   "
13540|NCT02880176|"~     Radical cystectomy with urinary diversion is associated with substantial perioperative~     morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional~     decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases~     the risk of readmission, and adds substantially to health care costs. Protocols that~     emphasize early and frequent ambulation after surgery decreases post-operative morbidity,~     but poor patient adherence diminishes the effectiveness of these protocols, which are~     currently implemented only during the hospital stay. Financial incentives overcome present~     bias and offer a novel and practical approach to increasing ambulation during the~     post-operative period in the hospital and also after discharge. This application proposes a~     pilot randomized, controlled trial to estimate the effect size of financial incentives on~     achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month~     following radical cystectomy. Secondary outcomes include step count, composite morbidity,~     and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy~     at the Hospital of the University of Pennsylvania will be randomized to either control~     (education of step goal with monitoring and daily feedback) or a gain financial incentive~     combined with a lottery incentive if they achieve 75% of the daily goals during the study~     period. Fitbit Zips will be used to measure step counts for all participants. This proposal~     will provide the preliminary data needed to design future, larger trials that will test the~     effect of financial incentives to increase ambulation on post operative complications,~     readmissions, and functional decline.~   "
13541|NCT02880163|"~     The purpose of this study is to demonstrate safety, effectiveness and benefit‐risk profile~     of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due~     to trauma in patients where emergent laparotomy is required.~   "
13542|NCT02880150|"~     Climbing at high altitude and tolerating hypoxic environment require specific physiological~     adaptations. Large intersubjects differences exist regarding the ability to adapt to high~     altitude and hypoxia. The present study aims to characterise the physiological responses to~     hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised~     that elite climbers would show better physiological responses to hypoxia and more preserved~     performances compared to sea level.~   "
13543|NCT02880137|"~     Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective~     non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and~     adult cardiac transplant recipients? Will perfusion deficits correlate with significant~     coronary artery stenosis identified by standard stress echocardiography and Invasive~     Coronary Angiography (ICA), and identify diffuse small vessel disease more effectively than~     current non-invasive techniques?~   "
13544|NCT02880124|"~     The purpose of this study is to compare the acute metabolic responses and time-trial~     performance following the ingestion of carbohydrate solutions containing either maple syrup,~     maple sap, corn syrup, a commercial sport drink or water.~   "
13545|NCT02880111|"~     Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different~     according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study~     is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a~     Pseudomonas Aeruginosa chronic colonization.~   "
13546|NCT02880098|"~     Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is~     increasing, yet normal values are still to be determined for the latest generation of tests,~     such as High sensitivity cardiac troponin T test. This study is an observational study~     designed to determine biological normal values of High sensitivity cardiac troponin T test~     (troponin T -us) in newborns.~   "
13547|NCT02880085|"~     The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from~     other muscular-tendinous pathologies is, actually, the injection of intra-articular~     anesthetic (lidocaine), with a pre- and post- evaluation of pain scale.~      If, after injection, the pain disappears, the pain is probably due to an articular problem~     (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity~     of 81%.~      C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be~     a marker, simply detectable, to assess the healthy of the cartilage status and could be~     measured in serum and urine.~   "
13548|NCT02880072|"~     A phosphate supplement is part of the treatment of patients with the refeeding syndrome~     (RFS). It is not known, if the generalized edema also affects the intestine to decrease~     absorption. The aim was to investigate, if oral treatment is possible in mild to moderate~     RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested~     four oral solutions of phosphate in two-day periods. In a low-dose period the investigators~     compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and~     potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period~     20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four~     hours after the ingestion, the urinary excretion after four hours.~      P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®,~     but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution.~     There was no difference in the increase between the patients with low p-phosphate and those~     with normal values, and no correlation between baseline p-phosphate and percent increase.~     There was no group difference in the urinary excretion of phosphate. The investigators~     conclude that phosphate can be readily absorbed after oral administration, but skimmed milk~     can´t be recommend for this purpose.~   "
13549|NCT02880059|"~     Patients with intracerebral aneurysm will be screened for sleep apnea using out of center~     polysomnography/polygraphy. Baseline blood pressure and medication will be assessed.~     Patients will be followed for up to 5 years to examine the increase in aneurysm size,~     rupture rate and changes in medication.~   "
13550|NCT02880046|"~     Purposes of this study are :~        -  Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro~          inhibition of PD-1/PDL-1 pathway~        -  Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of~          patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen~          because of use of anti-PD-1 or anti-PDL-1 antibodies~        -  Comparison of this technique with IFN-γ Elispot assay for detection and quantification~          of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.~   "
44936|NCT02468804|"~     We hypothesize that reductions in gamma activity are a key mechanism underlying cognitive~     dysfunction in PD and that interventions to increase gamma activity will improve cognition.~   "
13551|NCT02880033|"~     Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models~     to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC~     can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative~     stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron~     metabolism and programmed cell death ...). The platelets are pivotal in the healing system~     with large range of growth factors. A new therapeutic concept of conservative iron chelation~     with deferiprone for neuroprotection is under development.~      The action of deferiprone on the different mechanisms and notably the oxidative stress are~     to obtain from a collection of PBMC and platelets from patient having Parkinson's disease~     and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.~      PBMC and platelets will be stored for future analyses.~   "
13552|NCT02880020|"~     This randomized phase II trial studies how well nivolumab with or without ipilimumab works~     in treating patients with gastrointestinal stromal tumor that has spread to other places in~     the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and~     ipilimumab, interfere with the ability of tumor cells to grow and spread.~   "
13553|NCT02880007|"~     This prospective phase II trial study aims to optimize the increase in dose to the target~     volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume~     (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with~     locally advanced cervical cancer.~   "
13554|NCT02879994|"~     This phase II trial studies how well pembrolizumab works in treating patients with epidermal~     growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior~     tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal~     antibodies, such as pembrolizumab, may block growth in different ways by targeting certain~     cells.~   "
13555|NCT02879981|"~     This pilot, multicentric and observational study will assess the of safety of~     sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants~     with acute bronchitis. Administration of treatment will be according to physician's~     recommendation under local labeling.~   "
13556|NCT02879968|"~     Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and~     Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma~     antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.~   "
13557|NCT02879955|"~     To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1),~     after ingestion of glucose and fructose as separate monosaccharides or combined in the~     disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated~     subjects and BMI-matched controls.~   "
13558|NCT02879942|"~     Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of~     placental insufficiency. These complications affect 5-15% of pregnancies, and are~     responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have~     an increased risk for cardiovascular events, both at short and long term. This justifies the~     need to improve diagnostic tools to identify patients at risk for these complications. PE~     and IUGR are multifactorial entities. Screening algorithms should thus include several~     parameters to achieve high detection rates. Research has mainly focused in the analysis of~     biophysical and biochemical parameters, and the study of the placenta itself has not been~     included in current diagnostic strategies. Investigators hypothesize that detection rates of~     preeclampsia and intrauterine growth restriction could be improved by the study of placental~     characteristics in the first trimester of pregnancy.~   "
13559|NCT02879929|"~     Nasal symptoms are the main elements that lead to a therapeutic decision and allow for~     evaluating treatment effects or natural evolution. Despite availability of several~     questionnaires with good measurement qualities, no systematic assessment takes into account~     the specific physical and psychosocial consequences of each of the six main nasal symptoms,~     independently of the disease. The study proposed to measure these symptoms with the use of a~     selfreport questionnaire and to test the validity of the questionnaire in a large~     representative sample of patients attending outpatient rhinologic clinics.~   "
13560|NCT02879916|"~     This study describes the difference of analgesic effect of levobupivacaine 0.5% administered~     through an interscalene nerve block with or without a stellate ganglion block. The length of~     the analgesic effect is our primary outcome parameter. Half of the recruited patients will~     receive a stellate ganglion block and half of the patients won't.~   "
13561|NCT02879903|"~     The aims of the present study will be identify 5 types of fimbrial subunit genotype strains~     in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third~     two periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers.~     Clinical and microbiological parameters were evaluated at baseline and 3 months after~     periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession~     and Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene~     strains will be determined by Polymerase Chain Reaction.~   "
13562|NCT02879890|"~     National cohort study aimed to investigate the impact of comorbidities (number and type of~     comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).~   "
13563|NCT02879877|"~     This study is designed to evaluate the safety and tolerability of UCB7858 when given as~     single ascending doses administered by intravenous or subcutaneous infusion in healthy~     subjects.~   "
13571|NCT02879773|"~     This study uses CT scans to assess airflow in the lung, the scan is quick, cheap and~     painless. The information from the scan may help doctors tell which patients are suitable to~     have surgery to cure early stage lung cancer. It may also help doctors tell which patients~     would benefit from surgery for emphysema and diagnose types of lung disease. The~     investigators will follow up patients who go through surgery to test how well the scan~     predicts the function of the lung after surgery. The investigators will follow patients~     being investigated for lung disease to test how accurate the scan is at the getting the~     diagnosis right.~   "
13572|NCT02879760|"~     This is a Phase 1/2, multi-center, open-label, dose-escalation trial of Ad-MAGEA3 and~     MG1-MAGEA3 in combination with pembrolizumab in patients with Non-Small Cell Lung Cancer who~     have completed a first standard therapy with an platinum based chemotherapy.~   "
21054|NCT02781571|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir~     (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV)~     who have received a liver transplant.~   "
13564|NCT02879864|"~     Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often~     appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and~     persists for years after treatment in more than 35% of patients. Fatigue is the earliest and~     most important symptom described by cancer patients. Its prevalence in cancer chemotherapy~     patients is between 70 and 100%. Fatigue is more common to cancer patients and to the~     general population or other types of patients. Typically described as a lack of energy~     associated with mental disorders, fatigue related to cancer can be extremely debilitating.~     The causes are many, mainly including the cancer itself, side effects due to treatment,~     sleeplessness due to pain, anxiety or depression. The cancer-related fatigue has a negative~     and significant direct impact on all aspects of the patient's quality of life, especially~     the physical, social and behavioral. Despite the availability of certain treatments and the~     advanced biomedical research, fatigue remains an inevitable consequence of cancer and its~     treatment.~      The therapeutic use of natural light in medicine dates back to the late nineteenth century.~     Its remarkable effect on the stimulation of the immune system and fight against infections~     caused the development of the first therapy techniques (also called luxthérapie) awarded in~     1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the~     regulation of circadian rhythms and homeostatic. The mechanism of action passes through a~     path non-visual involving melanopsin ganglion cells located in the retina. Activation of~     the pineal gland (epiphysis) by melanopsin cells allows transduce information shadow and~     light in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is~     well established for treating fatigue-related disorders such as chronic fatigue, seasonal~     depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism~     is disturbed. Light therapy, by its mechanism of action, allows reprogramming of the~     biological clock and improved synchronization of circadian rhythms.~   "
13565|NCT02879851|"~     The study aims at quantifying the registration error obtained in routine patients in~     different parts of the prostate and for operators with different experience in order to~     assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.~      Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate~     cancer will be prospectively offered to enter the study.~      The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex,~     midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the~     prostate will be obtained at the end of the placement. As per our routine procedure,~     patients will undergo unenhanced prostate MRI to control the position of the fiducials. An~     elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively~     performed by operators of varying experience using the Koelis system. The fiducials (visible~     on MR and ultrasound images) will be used to quantify the registration error.~   "
13566|NCT02879838|"~     The purpose is to compare clinical, functional, professional and socio-economical~     characteristics of patients with occupational asthma and work aggravated asthma.~      Secondary purposes are:~        -  to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric~          oxide and cytology of induced expectoration;~        -  to estimate medical-social becoming of diagnosed work-related asthma after one year;~        -  to establish a biobank of blood samples of individuals with work related asthma for~          measurement of cytokines and search for genetic polymorphisms associated with asthma.~   "
13567|NCT02879825|"~     Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular~     apparatus with a prevalence of 2-3% in the general population. This valvular disease is~     generally considered as benign, but may at term evolve toward mitral valve regurgitation of~     various severity and/or arrhythmia.~      Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only~     patients with significant mitral regurgitation will undergo subsequent examination (24-hour~     external loop recording, exercise ECG, cardiac MRI) and a close follow-up.~      External loop recording and exercise ECG have an interest in the identification of patients~     presenting with arrhythmic complications, such as premature ventricular contractions, and in~     the global evaluation of hemodynamic consequences of the mitral regurgitation.~      More recently, detection of myocardial fibrosis among patients with MVP and severe~     ventricular arrhythmia has been identified. Fibrosis could evolve independently of the~     valvular regurgitation's severity and could be a substrate (myocardial scar) leading to~     ventricular arrhythmia. However, no study has specifically characterized myocardial lesions~     among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac~     magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and~     characterization, and echocardiography, particularly speckle-tracking imaging,~     identification of static (fibrosis) and/or dynamic (ventricular systolic deformation~     patterns using speckle-tracking strain) myocardial lesions.~      Identification of patients with impaired deformation patterns, fibrosis or with premature~     ventricular contractions may isolate a sub-group of patients with a higher risk of severe~     ventricular arrhythmia for whom a closer follow-up could be justified.~   "
13568|NCT02879812|"~     The purpose of the current study is to test a systems-level approach to disseminate a~     multicomponent, multilevel intervention consisting of educational materials about~     transplantation and the new kidney allocation system targeting dialysis facility Medical~     Directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 end stage renal~     disease Network regions across the United States will be randomized to receive intervention~     materials. The overall goal of the study is to extend the influence of the national~     allocation policy in reducing disparities in early steps in kidney transplant access.~   "
13569|NCT02879799|"~     In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are~     at greater risk for breathing and feeding problems, as well as infections, than babies born~     on their due date (full term). As a result, parents must leave their preterm babies in the~     hospital to fully develop and become healthy enough to take home. When it is time for~     discharge, parents are often not ready to look after their baby because they may have~     limited involvement in the care of their baby in hospital. In addition to the distress and~     costs to parents of having a baby in hospital, health system costs are also increased the~     longer a baby is in hospital. The purpose of this project is to test a new way to integrate~     parents into the care of their baby through a program called Family Integrated Care~     (FICare). In FICare, parents are educated and supported by nurses to provide care for their~     baby; nurses and doctors still provide intravenous medications and medical procedures.~     FICare has been tested in Ontario and shows promise as a better model of care for the small~     percentage of babies born more than 8 weeks early, who have to spend a long time in~     hospital.~      Now the investigators want to test FICare with the greater percentage of preterm babies who~     are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and~     if their babies are healthier. The investigators also want to know if FICare can reduce~     distress for parents. The investigators propose to test FICare in Level II Neonatal~     Intensive Care Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs~     and comparing the outcomes with the other Level II NICUs who do not use FICare. If FICare~     improves outcomes for preterm babies and their parents, the investigators will implement it~     in all Level II NICUs. In Alberta, the investigators want the best quality care for our most~     vulnerable babies and their parents. This project is aligned with Alberta's Health Research~     and Innovation Strategy priority of wellness at every age (child and maternal health), and~     with Alberta Health Services' quality of care goals to increase efficiency, effectiveness,~     appropriateness, and acceptability of health care services delivery.~   "
13570|NCT02879786|"~     The purpose is to determine the hierarchy of sensory afferents according to different forms~     of dyslexia in children.~      The secondary purpose is to determine sensitive and sufficiently specific posturographic~     indexes for standard diagnosis of different types of dyslexia.~   "
13575|NCT02879721|"~     Barrett`s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic~     transformations eventually can lead to cancer development. Today, the only way for early~     detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue~     sampling for histopathology, the latter being the only validated biomarker for esophageal~     adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient~     selection before inclusion into BE surveillance programmes.~      Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts~     being under different medical treatment. In a British epidemiological study 2007 Sjöberg et~     al noted a lower prevalence of EAC among patients treated with antihypertensive drugs~     interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and~     ACE-inhibitors. The last decade this endocrine signalling system has been proven to be~     involved in pathological conditions such as inflammation, wound-healing and even cancer, in~     several organ systems.~      Earlier reports from the investigators laboratory indicate the existence of a local RAS in~     the esophageal wall musculature and in the squamous mucosa. In the investigators latest~     explorative study, the investigators discovered the altered expression of classical RAS~     components in BE with and without dysplasia (unpublished results).~      By a possible alteration in RAS-related protein-expression in BE with increasing grade of~     dysplasia towards EAC, the investigator may have a possible pathway leading to biomarkers~     for cancer-development. Furthermore, the already well-known anti-hypertensive drugs~     ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The~     investigators therefore wish to test, in an exploratory prospective randomized~     placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the~     addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to~     see if the expressions of well-known biomarkers for cancer and inflammation are altered.~   "
13576|NCT02879708|"~     In several low and middle-income countries, Social Accountability (SA) interventions have~     been introduced as an innovative approach to governance, aiming to improve delivery of~     public services. These interventions typically include information provision to citizens~     regarding their rights/entitlements and local provider performance, and additionally,~     facilitation of community engagement with providers and officials.~      The state government of Uttar Pradesh (UP) and the Uttar Pradesh Health Systems~     Strengthening Project (UPHSSP) have identified 12 districts where the social accountability~     initiative will be introduced on a priority basis. This study focuses on interventions in 2~     of these districts (Sultanpur and Fatehpur), to study mechanisms through which information~     and collective action lead to improved accountability and outcomes. Within the 2 districts,~     the study is implemented as a cluster randomized evaluation with 120 villages randomized~     into 2 treatment arms and one control arm.~      This study aims to: (a) measure the causal effect of SA interventions on key outcomes~     (health status, quality of service); (b) test the effectiveness of social networks based~     strategies to disseminate information for community engagement; and (c) study individuals'~     decisions to participate in collective action efforts in the context of social networks and~     information interventions. In addition to evaluating the impact of the SA interventions, the~     study aims to generate new knowledge on relative strengths of information seeding~     strategies, identifying those that maximize the spread of information through the village~     network, and subsequently estimate peer effects on participation decisions.~   "
13577|NCT02879695|"~     This phase I trial studies the side effects and best dose of blinatumomab when given with~     nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+~     precursor B-lymphoblastic leukemia that has come back after a period of improvement or has~     not responded to treatment. Monoclonal antibodies, such as blinatumomab, nivolumab and~     ipilimumab, may interfere with the ability of tumor cells to grow and spread.~   "
13578|NCT02879682|"~     To compare presurgical motor mapping by navigated transcranial magnetic stimulation for~     surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data~     into neuronavigation as control.~      Primary objective: Permanently new postoperative deficit is lower when the preoperative~     motor mapping is available to the surgeon~   "
13579|NCT02879669|"~     The trial is an open-label, parallel group, multicentre trial that will recruit a total of~     30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a~     non-randomised safety phase and a randomised phase. The safety phase will consist of a~     lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised~     phase will not commence until the DSMB has deemed the safety lead-in data appropriate for~     continuation. A total of 24 patients will be included in the randomised phase; 14 patients~     will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will~     receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety,~     immune activation, clinical response and the correlation between clinical outcome and the~     immunological data.~   "
13580|NCT02879656|"~     The present collaboration study on the treatment of distal radius fractures is aimed to:~      (i) to compare the functional outcome in patient rated wrist evaluation (PRWE) score after~     closed reduction and cast immobilization and operative treatment with volar locking plate in~     the initial treatment of primarily unstable, non-reducible distal radius fractures in~     patients over 65 years.~      (ii) to compare the functional outcome in PRWE score after closed reduction and cast~     immobilization and operative treatment with volar locking plate in the treatment distal~     radius fractures with early instability during follow-up, ie. loss of reduction at one week~     (5 to 10 days) in patients over 65 years.~      (iii) to compare pain, disability, quality of life, grip strength and the number of~     complications after conservative treatment and initial and postponed operative treatment of~     distal radius fracture (iv) to assess the effect of pain catastrophizing score (PCS) on the~     functional outcome of conservatively and operatively treated distal radius fracture~   "
13581|NCT02879643|"~     This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined~     with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute~     lymphoblastic leukemia (ALL).~   "
13582|NCT02879630|"~     Patients receiving acyclovir as standard of care will be enrolled into this study. The~     currently recommended dosing strategy at our institution for obese patients is to receive~     intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have~     blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total~     time period of 12 hours. These patients will already be hospitalized for other reasons, and~     will not be required to make additional trips to the hospital. A total of approximately 4-5~     tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control~     (non-obese) patients will be enrolled.~   "
13583|NCT02879617|"~     This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1~     inhibitor durvalumab as first-line therapy in 50 patients with advanced NSCLC and ECOG~     Performance Status 2 (PS2).~   "
15930|NCT02848898|"~     This trial consists of application of little devices (named Equistasi®) generating focal~     vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The~     expected effects are on gait and postural instability.~   "
13584|NCT02879604|"~     Significant cognitive impairment (executive functions, memory, attention) is common in~     schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and~     atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years,~     alternative non-pharmacological therapeutics have been developed in schizophrenia. These~     techniques called cognitive remediation specifically target cognitive deficits. The first~     cognitive remediation available for patients was designed to stimulate new learning, or~     relearning, of cognitive tasks, and thus to improve certain deficient domains. These~     procedures were efficient in improving cognition as measured by neurocognitive tests but~     their impact on functioning and daily life was weak. In a second time, compensatory~     remediation has been developed. Compensatory approaches seek to make improvements in the~     patient's functioning by avoiding areas of impairment and recruiting other intact cognitive~     domains or by creating a supportive external environment. In recent meta-analysis~     compensatory remediation has larger effect-size than classical cognitive remediation, with~     an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of~     California) developed and tested a group-based, manualized, compensatory cognitive training~     intervention.~      Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily~     transposable in community care. Our team translated this method into French. The~     investigators planned a cost -utility study between CCT and treatment as usual in~     schizophrenia patients with less than 10 years of evolution.~   "
13585|NCT02879591|"~     The objective of AlterEgo is the creation of an interactive cognitive architecture,~     implementable in various artificial agents, allowing a continuous interaction with patients~     suffering from social disorders, by virtue of changes in behavioural (robot-based) as well~     as morphological (avatar-based) properties of that agent. The project includes research in~     fundamental and clinical neurosciences, interaction modeling, development of new~     computer-vision techniques and human-robot interfaces, as well as evaluation of the~     scenarios with patients before, during, and after training sessions. At the end of the~     project, the investigators will produce a new avatar-based clinical method able to enhance~     social interaction of patients.~      The first challenge of this project is to create an avatar alter ego of a patient. Based on~     recent work in social robotics and neurosciences, the investigators hypothesize that if~     patients face artificial agents morphologically and behaviourally similar to them, they will~     increase their social interaction. The second challenge is to transform the morphology and~     the behaviour of the similar artificial agent into that of a healthy and different agent.~     The investigators assume that the smooth and continuous behavioural shift from~     similar/unhealthy to complementary/healthy social behaviour will lead to a better social~     rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in~     service robotics. AlterEgo is an interdisciplinary project at the interaction of Social~     Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision~     (DFKI), and Psychiatry (CHU).~      This project includes a set of experiments that started in april 2014 and will terminate in~     september 2016 before undergoing a randomised clinical research.~   "
13586|NCT02879578|"~     Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of~     NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and~     adults with Tourette Syndrome (TS).~   "
13587|NCT02879565|"~     Progress in resuscitation has increased the chances of survival after anoxic or traumatic~     brain injury. More and more patients with severe cerebral damages are resuscitated but upon~     awakening from coma, some patients remain in a state which cannot be qualified as conscious~     and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative~     state). This condition can be transitory and evolve towards recovery, or remain chronic and~     lasting for years.~      To improve the diagnosis of patients with disorders of consciousness, recent advances in~     brain imaging have led to the development of new methods of detecting awareness. In the~     absence of overt behavioral responses from these patients, imaging-based diagnostic methods~     have been first used to assess whether some cerebral areas were preserved in UWS patients~     and showed an activation of the primary sensory cortices in some UWS patients, whether it~     occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical~     issues are raised for clinicians before responding to such requests:~        1. Is it technically possible to generalize neuroimaging protocols to all healthcare~          institutions?~        2. Is it ethically acceptable to propose neuroimaging protocols without an accurate~          estimation of their psychological impact on families and caregivers?~      The present study aims to understand and anticipate the technical and ethical issues related~     to an evaluation of consciousness with functional neuroimaging. How the evaluation of~     awareness in a patient affects the caregivers and family members will be investigated. By~     using qualitative research hopes and expectations will be clarified through the experiences~     of families, clinicians and nurses faced to this situation.~      Will be included in this research professional caregivers and persons closely related to UWS~     patients:~        -  Family members or close circle visiting the patients on a regular basis~        -  Referring clinicians~        -  Nurses in charge of the patients' care~      This prospective study uses qualitative, interview-based, research. Two key-moments are~     explored in succession to examine the impact of a neuroimaging evaluation of consciousness~     in institutionalized UWS patients:~        -  interviews of professional caregivers and families about their hopes concerning the~          evaluation of consciousness of UWS patients,~        -  interviews of professional caregivers and families about the impact of evaluating~          consciousness on their beliefs~   "
13588|NCT02879552|"~     Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with~     favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the~     efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.~   "
13589|NCT02879539|"~     Reducing power consumption in the cochlear implant is crucial to the development of future~     smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be~     more efficient in power consumption to the standard ACE strategy. However in order to~     develop smaller sound processors, further battery life power savings are required. The aim~     of this study is to evaluate three experimental sets of MP3000 parameter sets, compared~     against the default ACE program. In the background for each of the four strategies,~     experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an~     additional phase of the study, low stimulation rate ACE programs will also be evaluated~     against the default stimulation rate.~   "
13590|NCT02879526|"~     The purpose of this study is to investigate efficacy and safety of Chidamide Combined With~     Cyclophosphamide、Prednisone、Thalidomide in Treatment of Fragile Patients With~     Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center~     Study~   "
13591|NCT02879513|"~     This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP)~     versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced~     breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy.~   "
13654|NCT02878551|"~     The process of enhancing functional capacity of the individual in anticipation of an~     upcoming stressor has been termed prehabilitation. In the present pilot trial, the impact~     of a multimodal prehabilitation intervention composed of exercise, nutritional supplement~     and psychological well-being begun in the preoperative period will be evaluated.~   "
13592|NCT02879500|"~     Sugars have been singled out as one of the prime culprits in the dual epidemics of obesity~     and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means~     for displacing excess calories from free sugars in the diet. There is, however, a concern~     that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes.~     This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that~     sugars in the diet not be replaced with ASBs but rather with healthy options such as~     water. Whether ASBs more than water will contribute to obesity and diabetes remains unclear.~     To address this important question, the investigators propose to conduct a series of~     systematic review and meta-analyses of the totality of the evidence from randomized~     controlled trials and prospective cohort studies to evaluate the effects of water and ASBs~     in the development of overweight and obesity. The findings generated by this proposed~     knowledge synthesis will help improve the health of consumers through informing~     evidence/base guidelines and improving health outcomes by educating healthcare providers and~     patients, stimulating industry innovations, and guiding future research design.~   "
13593|NCT02879487|"~     The aim of this study is to assess a major complication of total laparoscopic hysterectomy,~     vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be~     operated for laparoscopic hysterectomy will be randomized to two different techniques. The~     colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the~     second group. All of the operations will be preformed by the same surgical at a university~     hospital. Vaginal dehiscence after surgery is the primary outcome measure.~   "
13594|NCT02879474|"~     State of the question Over the past decade, the incidence of melanoma (MM) has steadily~     increased in France and in most developed countries. This increased incidence was concerned~     mainly MM thin while the incidence of MM thick that represent the true killers, and~     mortality from MM remained stable or increased slightly over the same period. These~     epidemiological data and observations from everyday medical practice dermatologists suggest~     the existence of different growth patterns within MM. Indeed, some MM progressing slowly~     sometimes for decades before diagnosis but are thin at the time of resection. Conversely,~     others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection~     sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the~     relative mortality in MM, as improved screening failed to influence to this day.~      Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor~     of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to~     calculate the growth rate, an Australian team recently studied the growth rate in a~     population of patients suffering from MM. In this population 1/3 of MM had a growth of more~     than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals~     (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The~     European and Australian people are very different in particular regarding the prevention~     policy, these results can not be extrapolated to the French population.The main objective is~     to identify risk factors for FGMM in French propulation~   "
13595|NCT02879461|"~     Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes~     affecting the various vertebral segment structures, including: a joint zigoapofisária,~     yellow ligament, the articular capsule and the intervertebral disk. These changes decrease~     the area of the spinal canal and press the neural structures and may present clinically as~     the narrow tunnel syndrome.~      This presentation was first described by Verbiest associated with these anatomical changes~     the clinical manifestations; corresponding to low back pain, pain in the legs that worsen~     with the fact ambulate and improve with rest, this presentation called neurogenic~     claudication .~      The lumbar canal stenosis was divided into two main types; congenital and acquired . The~     first is associated with a reduced size of the pedicles, which leads to a reduction of the~     diameter of the spinal canal, common in patients achondroplasics . The acquired is~     considered the most common type and is associated with aging, including all anatomical~     structures of the lumbar segment .~      With an aging population the number of symptomatic patients is increasing, although there is~     no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical~     approaches to the spine in patients over 60 years of age (7).~      As described by Daffner et al a reduction in blood flow leads to production of inflammatory~     mediators, which associated with anatomical changes previously described lead to the~     clinical picture with lameness and pain in the lower limbs Treatment of these patients is~     beginning with guidance on the disease, adequate pain control, physical therapy and exercise~     for maintaining the activities of daily living. If these measures fail a surgical approach~     may be necessary, especially in patients with exercise intolerance, difficulty walking and~     urinary incontinence .~      The surgical approach despite being widely studied in the literature prospective controlled~     studies are rare, found series of case studies or retrospective studies, we try to evaluate~     the effectiveness of surgery compared to rehabilitation in symptomatic patients in an~     attempt to assess the impact of surgery associated with comparing therapy with isolated~     therapy in these patients.~   "
13596|NCT02879448|"~     The Amulet™ device will be evaluated for safety and efficacy by demonstrating its~     performance is non-inferior to the commercially available WATCHMAN® left atrial appendage~     closure device in patients with non-valvular atrial fibrillation. Patients who are eligible~     for the trial will be randomized to receive either the Amulet device or the WATCHMAN device~     and will be followed for 5 years after device implant.~   "
13597|NCT02879435|"~     This research will explore the question of whether preincisional skin infiltration with~     bupivacaine 0.25% decreases postoperative pain after Cesarean delivery.~   "
13598|NCT02879422|"~     Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these~     countries (and the gold-standard treatment, laser photocoagulation has proven to be~     effective in preventing vision loss at the end stage of eye disease due to proliferative~     diabetic retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing~     search for predictive factors of sight threatening stages of diabetic retinopathy has become~     more important.~      Previous studies that have examined candidate predictive factors for diabetic eye disease~     have mostly focused on systemic risk factors leading to PDR. Among various clinical~     parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration,~     neuropathy and elevated triglycerides have been associated with PDR.~      Some genetic factors may also account for the development of PDR and are prospectively~     considered in this study .~   "
13623|NCT02878954|"~     This research project aims to investigate the gender-based difference in patients with~     peripheral artery disease. To attend this, this study has two specific objectives:~      Objective 1: To identify gender-specific barriers towards exercise and physical activity in~     patients with peripheral artery disease (PAD).~      Objective 2: To evaluate gender-specific differences in functional capacity and~     cardiovascular function and regulation in patients with PAD at rest, during and following a~     single session of maximal exercise.~   "
14035|NCT02873585|"~     A comparison of caries detection rates between conventional intraoral bitewing radiography~     and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray~     source array. The secondary objective is to assess participants experience with the s-IOT~     device.~   "
13599|NCT02879409|"~     There are numerous possible reasons why it could be speculated that HbA1c variability may~     affect complication risk. Of interest are the concepts that both laboratory and clinic~     evidence suggests that periods of sustained hyperglycemia are 'remembered' (metabolic~     memory), this in turn is recognized to place patients at greater long-term risk of~     complications. As such it can be speculated that the detrimental effect of variability in~     HbA1c may be mediated via the same mechanism as 'metabolic memory' phenomenon.~      Aims: To determine whether treatment to one of 2 threshold levels will result in one group~     of type 2 diabetes patients having the same mean HbA1c but with differing HbA1c variability~     to that of another and related to markers of oxidative stress, inflammation and~     microvascular complications. To determine whether a difference in HbA1c variability between~     the 2 groups will reflect in changes in small nerve fibers assessed with the sensitive~     method of corneal confocal microscopy and cardiac autonomic function testing. To assess the~     reproducibility of HbA1c measurement from a whole blood samples initially analyzed and then~     stored at -80C until the end of the study (2-3 years), as well as storing an aliquot of~     haemolysate, for reanalysis at the end of the study.~      In one arm the investigators will intensify treatment in those with FPG>140mg/dl until their~     FPG is <90mg/dl, using whatever treatment is clinically appropriate for them, and only~     intensify it further if their FPG rises to >140mg/dl again. In the other group the~     investigators will intensify if their FPG is >115 mg/dl until it is <=115 mg/dl and~     intensify further if >115 mg/dl again. A total of 20 visits within a time frame of 2 and~     half years will be performed. Visits procedures will include routine biochemistry, eGFR,~     lipids, fasting glucose, insulin and full blood count, HbA1c, SHBG, hsCRP. EPIC and G-PAQ~     questionnaires will be collected. Autonomic function testing using deep breathing heart rate~     variability, and a sensitive measure of small fiber neuropathy using corneal confocal~     microscopy and a 24 hour urine collection for urinary isoprostanes to measure oxidative~     stress will be performed, at baseline, 12 and 24 months.~   "
13600|NCT02879396|"~     Saint Luke Home (SLH) is a home for low-income seniors who are ≥ 55 years and in need of~     basic living help in Tucson, Arizona. Reports shows that emergency calls are made from SLH~     (64 residents) around 60 times each year with emergency department (ED) visits and hospital~     admissions that follow. In 2014, a total of 70 calls were made, and in 2015, 49 calls. The~     Director, who is a nurse by training, and staff report that many of these calls are related~     to medications and may be avoidable. Therefore, we believe we can make a difference and~     decrease emergency calls, ED visits and hospitalizations that can be avoided with a program~     to teach the elders and staff at SLH. The program is called Preventing Avoidable Admissions~     Among Assisted Living Elders (PA4LE) and will consist of a 2-hour session every two weeks~     including home or clinic visits (elder preference), educational sessions, and staff~     training.~   "
13601|NCT02879383|"~     The Revita System is intended to improve glycemic control in patients with Type 2 diabetes~     who have preserved pancreatic beta cell function and whose diabetes is poorly controlled~     with oral anti-diabetic medications. The purpose of this study is to demonstrate the~     efficacy and safety of the Fractyl DMR Procedure using the Revita System compared to a sham~     procedure for the treatment of uncontrolled type 2 diabetes.~      Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham~     treatment arm will cross over to receive the DMR treatment at 24 weeks with background~     medications held constant from 24-48 weeks of follow up.~   "
13602|NCT02879370|"~     The technique the investigators propose to perform colorectal and colo-anal anastomosis in~     patients underwent low and ultra-low anterior resection for rectal cancer could potentially~     reduce the anastomotic leakage rate by better trans-anal introduction of the circular~     stapler, elimination of the previous suture lines and dog ears, combined with direct~     inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually~     direct repair of any small anastomotic defects. Another important point in cancer surgery is~     the easily identification of the distal margin. In fact, this technique is simple to~     perform, reproducible and safe in terms of complications.~   "
13603|NCT02879357|"~     The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious~     Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and~     allow control over their own decisions, relieve burdens of decision-making on family~     members, and help patients achieve a state of peace as they approach the end of life.~   "
13604|NCT02879344|"~     ECMO (extra-corporeal membrane oxygenation) is a blood oxygenation technical and~     purification of carbon dioxide by means of an extracorporeal circulation using a pump~     (identical to those used in cardiac surgery) and a membrane permitting gas exchange. This~     technique is used for almost 40 years in the acute respiratory distress syndrome (ARDS) but~     benefited from many technology improvements over the past 10 years.~      The circuit is now fully pre-heparin, not imposing obtaining activated partial~     thromboplastin time (aPTT) high. Centrifugal pumps limit the risk of intravascular~     hemolysis. The multi-perforated drainage cannula in place in femoral vein or jugular no~     longer need to maintain hypervolaemia to ensure sufficient flow.~      The membrane ensuring gas exchange is now polymethylpentene. This hollow fiber system~     ensures the gas exchange.~      In light of recent technical improvements, manufacturers indicate that the membranes can be~     used for 3 weeks. However, after a few days of use, fibrinoplaquettaires microthrombi form~     at the ECMO circuit, up from cannulas up to the oxygenator, decreasing membrane efficiency~     and imposing more early changes of the circuit. This hypercoagulable state was revealed~     through the study of classical plasma markers of coagulation. There is not so far from~     reliable predictive marker of thrombus formation, indicating a need to change the circuit.~      The production of microparticles (MPs) is a characteristic of cells subjected to an~     activation or apoptosis. MPs are membrane Smaller fragments released into the extracellular~     milieu after rupture of the asymmetry of the distribution of membrane phospholipids and~     characterized by the presence of phosphatidylserine (PhtdSer) on their surface, as well as~     various antigens expressed by their cells of origin. The PhtdSer is a pro-coagulating~     surface on which are going to assemble the enzymes responsible for the formation of thrombin~     and increases proportionally the TF activity ultimately leading to fibrin polymerization in~     the vessels.~      The vesiculation phenomenon exists in healthy subjects. In human pathology, many examples~     emphasize the fundamental role of MP in clotting or thrombosis. The PM generating fault is~     associated with bleeding disorders (Scott syndrome, dysvésiculation syndrome). Conversely,~     high circulating levels of MP are found in many thrombotic diseases (myocardial infarction,~     diabetes, antiphospholipid antibody syndrome, preeclampsia ...). Platelet and intense~     monocyte endothelial activation, observed in sepsis and severe trauma, is accompanied by the~     generation of procoagulant MP carriers of tissue factor (TF). These MP diffuse into the~     vascular compartment pathogenic potential may exacerbate inflammatory and thrombotic~     responses and play a leading role in triggering the DIC.~      More recently, various studies have shown that the microparticles are not only activation~     markers or injury, but also cellular elements having a true pathogenic role. Because they~     contain or express on their surface various biological effector (adhesion molecules, tissue~     factor, inflammatory mediators or apoptogenic, growth factor ...) the microparticles are~     able to interact with their environment and modulate cellular very different way the~     properties of target cells. And platelet or leukocyte microparticles could actively~     participate in the thrombotic process by increasing adhesion of monocytes and endothelial~     cells, or by inducing endothelial procoagulant response.~   "
13605|NCT02879331|"~     The study hypothesis is that patients with homogeneous emphysema behave differently compared~     to heterogeneous emphysema with respect to exercise capacity. A better understanding of this~     difference will allow the investigators to choose the best treatment for each type of~     patient.~      The main purpose of this study is to evaluate the change in exercise capacity measured by~     cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction~     with coils (eLVR).~      As a secondary purpose, the investigators want to perform an exploratory, randomized study~     to compare the results of two different therapeutic approaches in a small sample of patients~     with homogeneous emphysema.~   "
13606|NCT02879318|"~     The standard or usual treatment for this disease consists of two chemotherapy drugs~     gemcitabine and nab-paclitaxel given together.~   "
13607|NCT02879305|"~     The purpose of this multi-center event-driven study in participants with anemia associated~     with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.~   "
13608|NCT02879292|"~     Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal~     medical emergencies.This retrospective study will review the files of all infants with HPS,~     who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical~     Center between the years 2006 to 2015.~   "
13609|NCT02879279|"~     Stroke is frequently associated with significant disability and impaired quality of life.~     Persistent motor impairment is common with often incomplete recovery of motor function in~     response to rehabilitation, mainly in the upper limbs. Robot-mediated therapy has been~     proposed as a viable approach for the rehabilitation of the upper limb, but as the evidence~     quality is low, more rigorous studies are needed. Previous studies have focused on the~     effects of devices acting on a limited number of joints, often limiting the workspace on a~     plane. This study aims to evaluate the efficacy of a multi-set of robotic and technological~     devices for the rehabilitation of the upper limb in sub-acute stroke patients.~   "
13610|NCT02879266|"~     This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine~     TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus~     infection.~   "
13624|NCT02878941|"~     The objective of this study is to obtain and compare bilateral elbow joint synovial fluid~     from patients with unilateral intraarticular elbow fracture and a contralateral healthy~     appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for~     metabolites and proteins. Matched-pair statistical analysis will be performed to determine~     the metabolites and proteins that may play the greatest role in development of joint~     contracture.~   "
13611|NCT02879253|"~     This study is part of the french research program ANR NEMRO MICROROBOTIC NASAL ENDOSCOPY BY~     OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES.~     Recent studies have shown a strong correlation between the decrease in olfactory faculties~     of patients and the presence of neurodegenerative diseases.~      This possible relationship has created a need to inspect in detail the area of the nasal~     cavity that houses the olfactory function.~      Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of~     patients, with a view to extract images through non invasive imaging probe, and hoping to~     identify early signs of degeneration the olfactory tissue. The robot developed will thus be~     able to navigate in the nasal cavity of patients, and to break into the olfactory slots,~     which will host the imaging phase.~      The purpose of this study is therefore to collect data on the usual path of instruments~     (endoscope, for example) in this area, and future potential pathway of the robot. This~     collection made from Computed Tomography (CT) scans will define the clinical geometry of the~     target area and provide precisely the dimensional constraints needed to build the NEMRO~     robot .~   "
13612|NCT02879240|"~     Up to 50% of infants and young children cry during the administration of their inhaled~     treatment for their asthma. This results in decreased lung deposition, and thus decreased~     effectiveness of their inhaled treatment.~      The objective of this study is to evaluate whether animated cartoons can increase the~     cooperation of young children with asthma who are not cooperative during the delivery of~     their ICS therapy through a pMDI/spacer.~   "
13613|NCT02879084|"~     This study investigates the variations in the retinal nerve fiber layer (RNFL) thickness~     during uncomplicated anterior and intermediate uveitis, respectively. The objectives are to~     1 ) confirm the RNFL thickening during an uncomplicated anterior uveitis as described in the~     literature, 2) measure the RNFL thickness during an uncomplicated intermediate uveitis~     specifically and 3) describe the variation in time of RNFL thickness during the two types of~     uveitis.~   "
13614|NCT02879071|"~     The time-frame and the follow-up elements after embolization of brain arteriovenous~     malformations are not standardized. Therefore, few reliable follow-up data are available for~     these patients. This study aims at collecting standardized long term data for these~     patients.~   "
13615|NCT02879058|"~     This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic~     myomectomy impacts quality of life. Half of participants will undergo laparoscopic or~     robotic myomectomy with use of the intraoperative ultrasound and half will undergo~     traditional laparoscopic or robotic myomectomy.~   "
13616|NCT02879045|"~     The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of~     striae gravidarum: A randomized controlled clinical trial.~   "
13617|NCT02879032|"~     Exercise treadmill test (ETT) is frequently done, inexpensive, relatively safe investigation~     for diagnosis of ischemic heart disease and prediction of exercise capacity. Ischemic heart~     disease is increasing by leaps and bounds all over the world even in the developing~     countries like Bangladesh. The incidence rate of coronary artery disease (CAD) is not~     limited to male gender as previously seen. As a cause of industrialization and increased~     life expectancy, incidence of ischemic heart disease in females is escalating now in~     Bangladesh also. Though ETT is a well accepted investigation to diagnose CAD, it has a high~     false positive and false negative result if ST segment response alone is calculated for~     interpretation of the test. Duke Treadmill Test and Simple Treadmill Test are valid and well~     known scores which can predict coronary artery disease burden more efficiently than ST~     segment response alone. Computer generated Cleveland clinic score is another valid treadmill~     score which has a complex algorithm but effective way to predict 3 year and 5 year~     survivability. These three scores are well tested on western population but to our best~     knowledge there is little or no information regarding their predictability of CAD in~     Bangladesh. It's well known that ETT has a high false positive result in female population,~     so applying the scores may render ETT more efficient and abrogate unwanted risk of~     undergoing coronary angiography to diagnose CAD in females. In this study the investigator~     will try to find out the accuracy of commonly applied treadmill scores and ST segment~     response to diagnose CAD as well as accuracy of computer generated Cleveland Clinic Score~     will be tested. Total 110 people including male and female will be included according to~     inclusion and exclusion criteria and informed written consent will be taken. The patients~     who have undergone ETT and coronary angiogram with in six months for confirmation and~     identification of coronary artery disease in accordance with the recommendation of ACC~     guideline for CAG will be selected . All available data will be analyzed using SPSS. The~     accuracy of different scores will be calculated and compared with each other. According to~     currently available data from studies in western population the treadmill scores will have~     good predictability and will be efficient to abolish high false positive result in female~     population in Bangladesh.~   "
13618|NCT02879019|"~     Whereas the efficacy of exercise interventions has been abundantly proven in male with~     peripheral artery disease (PAD), it remains to be determined whether these interventions are~     effective in women. The aim of this randomized controlled trial which will be performed with~     34 PAD women will be to investigating the effects of 12 weeks of supervised walking on~     functional capacity and cardiovascular function and regulation at rest and during exercise.~   "
13619|NCT02879006|"~     The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in~     combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help~     children and adults who are allergic to foods be able to safely tolerate food allergens.~     Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew,~     hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for~     the treatment of food allergies in children and adults. Investigational means it has not~     been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers~     hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the~     outcome of sustained unresponsiveness (which is the ability to consume a food allergen and~     pass an oral food challenge after being off treatment for 3 months) as compared to placebo~     (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help~     adults and children be able to safely ingest the foods they are allergic to.~   "
13620|NCT02878993|"~     This study aims to assess whether the electrical signal of the diaphragm (diaphragm~     electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of~     the lungs) can predict which infants will be successfully extubated (have the breathing tube~     removed without needing it replaced.)~   "
13621|NCT02878980|"~     This clinical trial studies how well an exercise intervention works in reducing symptoms and~     improving clinical outcomes in patients with ovarian cancer undergoing platinum-based~     chemotherapy. Exercise may train the body to repair deoxyribonucleic acid (DNA) damage~     more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve~     quality of life, increase survival, and decrease recurrence rates in patients with ovarian~     cancer.~   "
13625|NCT02878928|"~     A prospective, multi-center, randomized, subject and outcome evaluator blind ,~     parallel-group study evaluating the effect of pharmacogenetic-guided versus standard of care~     treatment for subjects diagnosed with depression and/or anxiety disorders.~   "
13627|NCT02878902|"~     Kidney failure is a major public health problem. REIN registry shows that 33% of patients~     treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care~     is associated with an increased risk of morbidity and mortality, with less access to off~     dialysis center and kidney transplant. In addition, the emergency management has an impact~     on the organization of health structures. The High Authority of Health in 2012 issued a~     care pathway Guide aimed to report in this process of the multidisciplinary nature of the~     management and coordination of principles and procedures for the Chronic Renal failure and~     cooperation between professionals involved.  A function of coordinator of the Chronic Renal~     Disease was set up in service since May 2013. Investigators propose to carry out a study to~     value its impact on the start of the dialysis in emergency and hypothesize that this feature~     innovative in France improves the patient pathway and thus reduce support emergency~     frequency of ESRD.~      The objective of this study is to show the improvement of the quality of care for terminally~     chronic renal failure patients.~      This is to evaluate an experiment aimed to facilitate a complex care path. If this~     experiment is successful, it could form part of advanced practice.~   "
13628|NCT02878889|"~     A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen~     Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.~   "
13629|NCT02878876|"~     This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare~     effects of milk containing only A2 type beta casein versus milk containing both A1 and A2~     beta casein proteins on the gastrointestinal symptoms for the health people who~     self-reported to be lactose intolerant.~   "
13630|NCT02878863|"~     An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and~     tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild~     necroinflammatory activity on liver biopsy.~   "
13631|NCT02878850|"~     The purpose of this study is to learn more about how participants heal from acute spinal~     cord injury.~   "
13632|NCT02878837|"~     This randomized, open clinical trial sought to compare the use of Midazolam and~     Dexmedetomidine during surgery in patients under regional anesthesia.~      The primary objective was to determine the superiority of either drug during the~     intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.~      Secondary objectives included the determination of superiority regarding the postoperative~     period.~      For that, patients were randomized into two groups and sedated with either Midazolam or~     Dexmedetomidine.~   "
13633|NCT02878824|"~     Difference in autonomic nervous system processes across cultural and ethnic groups was~     suggested and autonomic regulation differentiation may occur even at an early age. However,~     the role of ethnicity and environment on regulation of response towards sensory stimulation~     in children is not well understood yet. This research aims to compare the autonomic activity~     at resting condition and toward a block of auditory stimulation between typically developing~     children from different countries and living environments. There will be two phases in this~     study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing~     Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino~     children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be~     recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U~     group), and (b) 32 typically developing Filipino children who are living at~     Philippines-Rural area (PH-R group). Participants will be composed of males and females ages~     7-12 years old, and without known history of developmental disabilities, medical history of~     cardiac or pulmonary problem, medical history of diabetes, or having any sensory deficits.~     Recruited participants will watch a silent movie, and listen to a block of sound. Autonomic~     activity (heart rate variability and electrodermal activity) will be measured and recorded~     using Polar H2 heart rate monitor and eSense skin response. Recordings will be screened for~     ectopic beats of HRV or bursts of EDA. The HRV and EDA signals will be processed by using~     aHRV and the eSense propriety software, respectively, and according to the standards of~     editing HRV and EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and~     hypothesis interaction between conditions (resting condition vs. auditory stimulation) and~     groups (HK group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group)~     will be tested with repeated measures of MANOVA. All significant levels will be set at p≤~     0.05. This study will increase the understanding on the role of culture and environment in~     the regulation of behaviour in auditory processing. The findings of this research may~     further shed light on the evaluation and treatment planning for children across and within~     cultures.~   "
13634|NCT02878811|"~     The investigators will consecutively recruit 5000 patients hospitalized for heart failure~     (HF) from 50 hospitals across China and follow them up for one year, describe treatment~     patterns during hospitalization and the follow-ups, examine patients recovery trajectory~     after HF, and identify targets for care quality improvement.~   "
13635|NCT02878798|"~     The TopCSPN trial is a double blinded randomized placebo controlled study of oral topirmate~     as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy~     (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria)~     who do not have an alternative cause for neuropathy will be potentially eligible. The co~     primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy~     (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The~     treatment phase will last 24 months.~   "
13636|NCT02878785|"~     The purpose of this study is to find the best way to combine a new chemotherapy drug with~     one that is already in use to treat AML. The new experimental drug is called talazoparib~     (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA).~     The FDA is allowing the use of talazoparib for the purposes of this study.~      Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as~     well as off label for AML.~      Lab work suggests that talazoparib will increase the effects of decitabine in leukemia~     cells.~      Investigators hope that treating patients with decitabine and talazoparib together will be~     more successful that treating patients with decitabine alone.~      This study has two parts. The purpose of part one the study is to find out the best doses of~     decitabine and talazoparib to use when they are given together to treat AML. The purpose of~     part two is to see how well the drugs work together to treat AML.~      All participants in the study will be treated with decitabine and talazoparib.~      Part one of the study will include as few as two people and as many as 36 people to find the~     best dose levels of the study drugs. Part one will begin enrolling first. Part two of the~     study will not start until the Part one of the study is complete. Participants will be told~     which part of the study they may be enrolled in. Part two of the study may include as few as~     79 people and as many as 135 people. Part two includes three separate arms. Participants~     enrolled in Part two of the study, will be assigned to one of the three arms below in order~     to test the success rate of the study drug dose determined by Part one:~        -  Arm A will enroll adult patients with AML who are thought not to be likely to tolerate~          or respond to standard chemotherapy;~        -  Arm B will enroll adult patients with AML that has not responded to previous treatment~          or has come back after responding to previous treatment;~        -  Arm C will enroll adult patients previously treated with a DNA methyltransferase~          inhibitor (decitabine, azacitidine or guadecitabine).~      This is a multi-center study. Up to 171 people may take part in this study globally.~   "
13637|NCT02878772|"~     Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke.~     Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration.~     Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the~     outcomes of stroke. For this multi-center study, investigators recruited 60 patients with~     anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but~     lasted less than 48 hours. These patients, after randomly division into two groups, received~     either standard management alone (controls) or standard management plus vinpocetine (30 mg~     per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).~   "
13639|NCT02878746|"~     The investigators developed a real-time 2-axis mirror robot system as a simple add-on module~     for conventional mirror therapy using a closed feedback mechanism, which allows for~     real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke~     patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions).~     For the conventional mirror therapy group, the investigators prepared the tasks for fine~     motor training.~   "
13640|NCT02878733|"~     The invesitgators utilized the Cerner HealthFacts database (a large HIPAA-compliant~     clinical-administrative database maintained by Cerner Inc., USA) to identify a cohort of~     6,249 adults that underwent on-pump cardiac surgery for valve and/or coronary artery~     procedures between January 2001 and March 2013. Of these, the investigators selected 1136~     patients who received 5% albumin on the day of or the day following cardiac surgery and~     matched them (1:1) with 1136 patients who did not receive albumin. Characteristics on which~     patients were matched included patient demographic, hospital and procedural characteristics,~     baseline patient comorbidities including preoperative CKD and 26 other grouped conditions,~     as well as acute severity of illness at admission to ICU.~   "
13641|NCT02878720|"~     Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus~     nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present~     study is to explore whether the combination of these two approaches might enhance their~     positive effects on motor recovery. Safety and efficacy of this combination will be assessed~     within a proof-of-principle, double-blinded, randomized, sham-controlled trial.~     Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to~     improve the response to the following robot-assisted therapy. Patients with both ischemic~     and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with~     real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as~     primary outcome, while changes in several quantitative indicators of motor performance~     extracted by the robot as secondary outcomes.~   "
13642|NCT02878707|"~     Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In~     brain tumor resection craniotomy, it is proven to be effective in improving postoperative~     hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives~     postoperative pain. In addition, many animal experiments show that DEX inhibits the~     proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also~     reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral~     focal ischemic region (penumbra). However, the neuroprotective effects were never~     investigated clinically in patients undergoing brain tumor resection surgery.~   "
13643|NCT02878694|"~     Interventional , multicenter , comparative study. One eye receiving the cells and the~     contralateral eye as a negative control . If effectiveness following review of the primary~     endpoint and the advice of an independent expert committee , the experimental treatment will~     be offered to the patient to the contralateral eyelid.~      Objective is to restore muscle function levator muscle of the upper eyelid by providing a~     registry of autologous myoblasts from a non- clinically affected muscle .~   "
13644|NCT02878681|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF levels in DME patients in a detailed time course.~   "
13645|NCT02878668|"~     Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is~     the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful~     in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study~     is to assess the predictive value of biomarkers for early complication after~     hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.~   "
13646|NCT02878655|"~     The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is~     one of the main factors of poor prognosis, justifying the surgical management of neck~     dissection as a reference treatment.~      Under the influence of the American Hayes Martin, it was considered until the 1960s that~     over the intervention was, the greater the chance of recovery was. But has since been~     developed by the Argentine Osvaldo Suarez the concept of functional course, which consists~     of resection of lymph node tissue while retaining the main structures (muscles, nerves,~     vessels), as opposed to the recess radical which is reserved for the invasive metastasis.~      In addition to these notions, our job is to evaluate the quality of life of patients with~     SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb~     sector to support the approach which would be to stop the systematic inclusion of this~     territory.~   "
13647|NCT02878642|"~     The main assumption is that the dolutegravir can get virologic suppression to suboptimal~     adherence levels (between 80 and 95%, and after treatment interruptions) where other~     molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).~      While the investigators goal is not to compare molecules (study with one arm) in terms of~     forgiveness, the results of this cohort in terms of forgiveness could be compared to other~     cohorts available.~   "
13648|NCT02878629|"~     The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular~     Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and~     Hypopneas.~   "
13649|NCT02878616|"~     Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter~     the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate~     dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting~     kidney transplantation~   "
13650|NCT02878603|"~     The objective of this study is to evaluate long-term safety and efficacy of caplacizumab, to~     evaluate safety and efficacy of repeated use of caplacizumab and to characterize long term~     impact of TTP.~   "
13651|NCT02878590|"~     Prospective, non-randomized, open label study~   "
13652|NCT02878577|"~     This project, will combine the data collected from existing and innovative technologies:~     fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology~     (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic~     resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging~     of brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is~     responsible for recruiting patients from the Department of Neurosurgery and Department of~     Rehabilitation and also is responsible for performing the needed tests.~   "
13657|NCT02878512|"~     Management of nephrolithiasis has been revolutionized by the advent of shock-wave~     lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive~     endoscopic technique and is used for the fragmentation and removal of stones of size more~     than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL~     is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the~     possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is~     the gold standard for this surgery.The advent of new drugs has refined the technique of~     general anaesthesia. However there are several issues related to prone position still to be~     addressed like accidental extubation and difficult reintubation, nerve injuries and post~     operative respiratory complications.~      Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established~     technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also~     been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from~     the surgical site. This not only allows to limit the dose of the local anaesthetics, but~     also limit motor and sympathetic blockade. Selective sympathetic block is associated with~     respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our~     current study. In the present study the investigators aimed to evaluate the efficacy of~     segmental epidural for PCNL and compared it with standard technique i.e. GA.~   "
13658|NCT02878499|"~     The primary objective of this study is to undertake a longitudinal investigation of the~     impact of sleep and circadian rhythm disturbances on cognitive and behavioural trajectories~     in children with autism spectrum disorder (ASD) age 3-10 years old.~      This innovative study will use objective quantifiable measures of sleep and circadian~     rhythms in addition to subjective measures.~      The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,~        1. sleep disturbances are correlated with circadian rhythm disturbances;~        2. both sleep and circadian rhythm disturbances are negatively correlated with cognitive~          performance and positively correlated with behavioural disturbances;~        3. sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion,~          impact the cognitive and behavioural development of children with ASD, depending on age~          (prospective longitudinal analyses).~   "
13659|NCT02878486|"~     The purpose of this study is to determine whether the researchers can help people change the~     amount of time they spend in sitting activities and whether this change might improve health~     outcomes.~   "
13660|NCT02878473|"~     Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with~     liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres~     due to historically poor results. Two retrospective evaluations have shown a 5 year survival~     ~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver.~     This suggests that LT can be a curative treatment if applied selectively. This study will~     evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic~     patients who meet the strict selection criteria. Patients with advanced cirrhosis (not~     candidates for resection) currently have no other curative treatment options. Participants~     will be allowed bridging therapies prior to receiving transplant. Participants will be~     followed for 5 years from the time of transplant with patient survival and disease~     recurrence as outcome measures.~   "
13661|NCT02878460|"~     The ORI (Reserve Oxygen Index) is an index measured through sensors SpO2 (oxygen saturation~     by pulse oximetry - Radical-7 MASIMO) that evaluates noninvasively PaO2 (partial pressure of~     oxygen). It represents the high PaO2 with values to 0 for a PaO2 <100 and up to 1 when the~     PaO2 rises above 200 mmHg. Monitoring by the ORI, with setting an alarm for low values~     (≥0,01) could help alert nurses when to decrease the FiO2 (inspired oxygen fraction). This~     could reduce the FiO2 and avoid hyperoxia (i.e. daily PaO 2> 80 mmHg or 100). In the~     literature, hyperoxia can be associated with prolonged mechanical ventilation, with~     increased risk of atelectasis, or with excess mortality. And the use of high FiO2 led to a~     over-consumption of oxygen and therefore to additional costs.~      The purpose of this feasibility study is to evaluate the use of ORI can help to decrease~     length of moderate hypoxemia (PaO2>100mmHg) during mechanical ventilation and~     oxygenotherapy, in comparison with monitoring the SpO2 only.~   "
13662|NCT02878447|"~     The sequelae of tuberculosis are still the commonest causes of haemoptysis in the developing~     world, where life-threatening haemoptysis remains a common and not infrequently fatal~     medical emergency. Haemoptysis can be life-threatening either as a result of compromised gas~     exchange or because of circulatory collapse secondary to acute blood loss. Haemodynamic and~     ventilatory support, followed by bronchial artery embolisation (BAE) as a bridge to~     potentially curative treatment such as lung resection, remains the standard of care. Often~     patients do not qualify for surgical intervention and BAE is, at best, a temporary solution.~     External beam radiotherapy (EBRT) may be an alternative, curative intervention in the~     management of haemoptysis in patients with no alternative options. There is a paucity of~     studies reporting the use of EBRT in patients without malignancy and with regards to~     specific doses of EBRT. This pilot study aims to explore the potential of varying doses of~     EBRT in the management of massive haemoptysis.~   "
13663|NCT02878434|"~     The researchers aim to record the incidence, treatment and long term follow up of fertility~     preserving cancer treatment. Both the oncological and fertility outcome are recorded.~      Study population: All patients with a cancer for whom a fertility preserving cancer~     treatment is applied. The results of the study population are compared to young women~     undergoing standard cancer treatment.~   "
13664|NCT02878421|"~     The purpose of this study is to assess the effects of electronic cigarettes-nicotine and~     electronic cigarette-nicotine free on endothelial function as compared to traditional~     cigarettes.~      Participants will be randomized to one of three groups in a 1:1:1 fashion. The groups will~     be:~        1. Continue with tobacco cigarettes~        2. Switch to electronic cigarettes containing nicotine plus flavor~        3. Switch to electronic cigarettes containing flavor alone Treatment period will be 28~          days~   "
13675|NCT02878278|"~     1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and~          pharmacodynamics between two different method of drug administration: 10mg, daily and~          30mg/d, twice every week, and find out the more effect way of Chidamide administration.~        2. To examine whether Chidamide could activate EB virus, and whether the above two~          different ways of administration are different in EB virus activation.~   "
13665|NCT02878408|"~     Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far~     missing in psychiatry, and to design innovative treatment approaches based on the discovery~     of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known~     to be significantly associated with neuro-inflammation, the project I-GIVE will combine~     multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global~     hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between~     susceptibility to environmental factors (such as winter-spring births, infections,~     urbanicity…) and genetic factors controlling immune responses.~      Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical~     profiles and immuno-inflammatory/immuno-genetic markers, and description of~     patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to~     design innovative treatments and foster personalized psychiatry tailored to the needs of~     each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a~     preclinical model for their ability to slow, stop, or even reverse the progression of the~     psychosis in patients. I-GIVE project should thus lead to major results that will have~     strong impacts on the scientific community, pharmaceutical industries and, in a longer term,~     on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.~   "
13666|NCT02878395|"~     The purpose is to search for enterocyte-specific or non-specific molecular signature of~     post-operating recurrence of Crohn's disease in transcriptome (measurement of gene~     expression through number of mRNA copies transcribed for each gene) and in methylome.~      Secondary objectives are to compare expression and methylation profiles according to:~        -  treatment response~        -  morphological (endoscopic and/or radiological) and clinical post-operating recurrence.~   "
13667|NCT02878382|"~     In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing~     prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL),~     is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).~      Reduced response rates are observed in thicker skin lesions, which may be due to~     insufficient PpIX accumulation within the target tissue.~      To enhance PpIX production,several physical and chemical pretreatments have been suggested.~     One of the chemical substances proposed to stimulate PpIX production is vitamin D because of~     its ability of being a keratinocyte pro-differentiating hormone.~      Based on in vitro and in animal model studies, we propose to study the potential impact of~     patient vitamin D pre-treatment in AK response to MAL-PDT.~   "
13668|NCT02878369|"~     In order to identify the responding patients with vascular filling test, this research aims~     to compare the performance of the increased flow in the femoral artery to the performance of~     the blood pressure increase.~      The reference measurement will increase cardiac output measured by ultrasound.~   "
13669|NCT02878356|"~     In the Swedish county councils and municipalities, Motivational Interviewing (MI) training~     with different forms and content is taking place as part of the implementation of the~     method. The study aims to evaluate to what extent the practitioners acquire and retain MI~     skills trough the different training methods used by comparing them with a format that in~     previous studies has shown to be required for the long-term acquisition of proficiency in~     MI; training including supervision consisting of feedback based on monitoring of practice.~   "
13670|NCT02878343|"~     This study will evaluate the comparative effectiveness of behavioral economic financial~     incentives and environmental strategies, separately and together, in achieving initial~     weight loss and maintenance of weight loss, in obese employee populations. Our study~     contributes to the Centers for Disease Control and Prevention's efforts to combat obesity~     but in particular to the Centers for Disease Control's winnable battles (physical activity~     and obesity); the National Center for Chronic Disease Prevention and Health Promotion's~     strategic priorities around well-being, health equity, and evaluation and dissemination of~     environmental and systems-wide solutions to address public health problems; and the National~     Center for Chronic Disease Prevention and Health Promotion's domain around healthier~     work-site initiatives, the Centers for Disease Control and Prevention's efforts to improve~     nutrition and physical activity to prevent obesity, and reduction of cardiovascular disease~     risk. This study is a 4-arm randomized controlled trial in which 344 employees of the City~     of Philadelphia, Independence Blue Cross, and South Eastern Pennsylvania Transportation~     Authority with initial Body Mass Index of 30 will be randomized to receive one of the~     following: 1) Daily lottery type incentives tied to achievement of weight loss goals~     (incentive arm); 2) individually tailored environmental strategies around food intake and~     physical activity (environmental arm); 3) a combination of incentives and environmental~     strategies (combined arm); or 4) standard employee wellness benefits and weigh-ins every 6~     months (control arm). Phase I of the study (first 6 months) will focus on weight loss; Phase~     II (months 7-18) will focus on continued weight loss or maintenance for those who choose to~     maintain weight loss as opposed to continuing to try to lose weight; Phase III (months~     19-24) will provide a period of post-intervention follow-up to measure sustainability of~     effects.~   "
13671|NCT02878330|"~     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and~     antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29~     and 35 weeks gestational age and entering their first RSV season.~   "
13672|NCT02878317|"~     The purpose of the present study is to investigate the association between the accumulation~     of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people~     receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as~     the impact of a dietetic intervention on AGE accumulation. AGE will be measured~     non-invasively in the skin using a technique called skin autofluorescence (SAF).~      The present study will be conducted in two parts:~      Study 1: this will be a prospective study where participants will be followed-up for up to~     five years. The research team will measure the accumulation of AGE in the skin using a quick~     (less than five minutes) and painless technique called SAF. This involves placing the~     forearm on a piece of equipment that shines a light on the skin and measures the amount of~     light that is reflected back. Participants will be asked to complete nutritional and quality~     of life questionnaires, measurements of weight, height, arm circumference and skinfold~     thickness (i.e. anthropometry), simple eyesight tests and blood tests.~      Study 2: participants will be randomly assigned either to a low AGE diet (intervention~     group) or to a standard diet for people on dialysis (control group). Participants will be~     followed-up for 2 years and will receive precise oral and written instructions on how to~     comply with the diets. Blood and eyesight tests, SAF measurements, anthropometry and~     nutritional and quality of life assessments will be conducted.~      In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE~     levels and do some additional blood tests to help us investigate the effects of AGEs on the~     body. If the participants agree, the investigators will also store some of the blood for~     future research.~   "
13673|NCT02878304|"~     The overall aim is to identify key determinants for recovery of hand function after stroke~     by applying newly developed hand function measures together with MRI measurements of the~     lesioned cerebral structures.~   "
13678|NCT02878239|"~     Static imaging has been commonly and clinically accepted to assess the severity of medial~     knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to~     evaluate the kinematic characteristics of the knees in patients with KOA. Most of the~     current studies focus on the sagittal plane of the knee, but very few of them focus on the~     frontal or horizontal plane. With the different severity of medial KOA, anatomical~     structures of the knees will change and influence kinematics of the knees, such as~     osteophytes and deformity. At present, there has been no study focusing on the relations~     between the imaging assessment of the severity and quantitative kinematics of medial KOA.~     The aim of the study is to explore the relationship between the imaging assessment based on~     the Kellgren-Lawrence Scores and in vivo 3D knee kinematic characteristics in Chinese~     patients with medial KOA during walking using a new portal gait system.~   "
13679|NCT02878226|"~     Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated~     with an increased risk of maternal and perinatal morbidity and mortality, particularly in~     developing countries compared to developed countries. UR occurs mainly as a consequence of~     poorly managed labour~   "
13680|NCT02878213|"~     The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric~     sensing compared with customary electrical isolation tests and Adenosine infusion at the end~     of the procedure. Furthermore, safety, usability and clinical applicability of the system~     for guided AF ablation will be confirmed.~   "
13681|NCT02878200|"~     Reactive treatment of household contacts of a confirmed malaria case has been shown to~     reduce infection prevalence since the former as they are at an increased risk of infection.~     However, implementing this on a programmatic scale poses significant pressure on the health~     system and may not be sustainable without the active involvement of the recipient community.~     This study investigates a novel approach to reducing residual malaria transmission that~     combines the elements of active community involvement in reactive treatment of household~     contacts of a clinical case reporting at a health facility. The investigators hypothesize~     that in areas of low transmission (prevalence of infection ≤10%), most asymptomatic carriers~     are clustered around clinical malaria cases in the same households. Also, targeting~     individuals sharing a sleeping area with diagnosed malaria case will reduce parasite~     carriage in the community. This is a cluster-randomized trial where villages in Central and~     Upper Baddibu, North Bank East Region of The Gambia, are randomized to receive either~     reactive treatment of household contacts following a confirmed case of malaria or standard~     care, i.e. treatment of index case only. Formative research into community perception and~     reaction to self-administered treatment will be used to generate, adapt and evaluate~     messages that encourage adherence and compliance to treatment. This will be tested in the~     first year of the implementation, and findings used to develop a final model of messages to~     be implemented in the second year of the study. The primary outcome is the prevalence of~     malaria infection, determined by molecular methods, in all age groups at the end of the~     second intervention year and the incidence of clinical malaria during the transmission~     season.~   "
13682|NCT02878187|"~     Bleeding is the most significant cause of maternal death worldwide with more than half of~     those occurring within the first day of delivery. About 10.5% (some estimate as high at~     12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum~     hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and~     placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of~     Cesarean hysterectomies done for abnormally adherent placentation~   "
13683|NCT02878174|"~     Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when~     the internal jugular vein cannulation is attempted with US. This study is a clinical trial~     that compares the success rates of both techniques and shows the non-inferiority of the~     prelocation technique. However, during prelocation technique, rotated screen of the US is~     used instead of original screen. The angle of rotation is determined by the degree of~     rotation of US probe where an accelerometer is attached.~   "
13684|NCT02878161|"~     Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a)~     inhibitors have demonstrated an outstanding performance in relieving joint inflammation and~     retarding bone erosion involved in RA. However, there is still about one-thirds of RA~     patients had a poor response to TNF α inhibitors. The Investigators hope to discover~     prediction protein with a domestic genetic background and finally establish prediction~     system with Chinese characteristics.~   "
13685|NCT02878148|"~     Prospective single centre study aiming at validating a conditional imaging strategy for~     diagnosis of suspected kidney stone.~      Consecutive Emergency department patients referred to the medical imaging department for~     exploration of a suspected acute uncomplicated renal colic will undergo the following~     interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic~     unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment~     of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical~     prediction score for symptomatic stone.~      Patients will be followed up at 1 month to record the need for urologic intervention and its~     type.~      The performances of different conditional imaging strategy for the diagnosis of suspected~     renal colic will be assessed retrospectively. The conditional strategies tested will be~     based on the patient's stone score and BMI and targeted use of combined plain X-ray and~     ultrasonography and/or unenhanced CT.~      The reference diagnosis for renal colic will be made according to the finding of a ureteral~     stone or indirect signs of urolithiasis at unenhanced CT.~   "
13686|NCT02878135|"~     intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's~     often complain that its placement is one of the most uncomfortable parts of this procedure~   "
13687|NCT02878122|"~     Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking~     surgery and chemotherapy based on taxol and carboplatine. Initial response is often good,~     but most often a recurrence occurred in the first 18 months. Early recurrence signs~     chemoresistance and palliative treatment. The study of predictive clinical or biological~     factors is required to adapt therapeutic and develop new treatments.~   "
13688|NCT02878109|"~     This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy~     of trans-arterial chemoembolization by comparing imaging results before and after treatment~     for at least one untreated hepatic tumor.~   "
13689|NCT02878096|"~     The primary objectives of the study are:~        -  To determine the absolute bioavailability of SK-1404~        -  To assess the mass balance recovery after a single oral (PO) dose of carbon-14~          (14C)-SK-1404~        -  To provide plasma, urine and faecal samples for metabolite profiling and structural~          identification~      The secondary objectives of the study are:~        -  To determine the routes and rates of elimination of [14C]-SK-1404~        -  To identify the chemical structure of each metabolite with an exposure (AUC) of more~          than 10% of circulating total radioactivity~        -  To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404~        -  To further explore the PO PK of SK-1404~        -  To provide additional safety and tolerability information for SK-1404~   "
13690|NCT02878083|"~     The main objective of this project is to demonstrate the feasability of an endomicroscopic~     biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling~     vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab~     to rhodamine.~      This project should allow the development of a biomarker of therapeutic efficacy for~     vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while~     respecting manufacturing standards and Good manufacturing procedures.~   "
13691|NCT02878070|"~     My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower~     adults with chronic spinal cord injury (SCI) in the self-management of their primary health~     care needs to prevent secondary conditions. In a randomized controlled trial, participants~     assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for~     six months. PHCs are experienced, empathetic peer mentors living with SCI who act as~     supporters, role models, and advisors, providing goal-setting support, motivation,~     education, and resource referral to participants. Participants complete surveys at baseline,~     2, 4, and 6-months, as well as qualitative exit phone interviews.~      It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care~     interactions as reflected in increases in three domains of self-advocacy: assertiveness,~     illness education, and potential for mindful non-adherence, 2) Increase participants'~     self-efficacy for health care navigation, preference for involvement in, and satisfaction~     with their primary care physician (PCP), and 3) Increase health related quality of life and~     medical social support compared with those receiving usual care. Additional secondary~     hypotheses state that the MCMC intervention will increase access to primary care and use of~     preventive screening services compared with those receiving usual care.~   "
13692|NCT02878057|"~     The treatment of the patients with recurrent and metastatic breast cancer remains a major~     problem. There is still a lack of effective targeted therapy for Her-2 negative breast~     cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast~     cancer, the investigators believe that it is necessary to further explore the efficacy and~     safety of apatinib in advanced breast cancer.~   "
13693|NCT02878044|"~     The objective of this project is to evaluate a treatment decision aid for patients with low~     risk thyroid cancer.~   "
13694|NCT02878031|"~     This one-arm safety intervention study is aimed at increasing access to treatment of~     pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons~     (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups~     and recording their findings in case report forms. CORPs will also be involved in improving~     care seeking for pneumonia in children by training them to conduct health education sessions~     for men and women in their respective communities.~      The primary objective is to assess if CORPs can safely and appropriately manage chest~     indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The~     primary outcomes will be the proportion of children under five with chest indrawing~     pneumonia who were managed appropriately by CORPs and the clinical treatment failure of~     chest indrawing pneumonia. Secondary outcomes will include proportion of children with chest~     indrawing followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and~     clinical relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia~     disappeared by day 6. Approximately 308 children 2-59 months of age with chest indrawing~     pneumonia would be needed for this safety intervention study.~   "
13695|NCT02878018|"~     Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary~     glomerulonephritis in children.This is an important chronic disease endangering children's~     health.The main drugs in clinic are glucocorticoid,immunosuppressants and~     anticoagulation.Subject group concluded a series of prescriptions to treat children with~     purpura nephritis:Qijishenkang lotion,Zhubai lotion,More Kidney lotion.Prospective cohort~     study of clinical research methods are adopted.To develop clinical diagnosis and treatment~     scheme which can be widely used to treat children with purpura nephritis (Heat Toxin~     Injuring Collaterals Type,Damp Heat Injuring Collaterals Type,Qi Deficiency and Blood Stasis~     Syndrome).~   "
13696|NCT02878005|"~     The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal~     Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the~     passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was~     designed to assess the success rate of blind and fiberoptic endotracheal intubation using~     iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.~   "
13697|NCT02877992|"~     The purpose of this project is to study the presence of expression differences - at RNA and~     protein level - of different members of the tachykinin family and kisspeptin and their~     receptors, between fertile women and infertile patients with different etiologies.~   "
13698|NCT02877979|"~     A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety~     and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to~     healthy HIV-negative women.~   "
13699|NCT02877966|"~     The primary objectives of this study are to evaluate the effects of an amino acid mixture~     (Amixea) on the body composition as assessed by DXA, and on QMVC as assessed by strain~     gauge, in advanced NSCLC patients, compared to placebo, after 10 weeks of treatment.~      Secondary objectives are to evaluate the activity of Amixea on the degree of protein~     synthesis, on the nutritional risk and status and quality of life in advanced NSCLC~     patients, compared to placebo, after 10 weeks of treatment. In a small subsample, body~     composition will be evaluated opportunistically from clinically available CT scans.~      Adherence to, and patient satisfaction of treatment will be evaluated as exploratory~     objectives of this study. Finally, the overall safety and product tolerability will be~     evaluated.~   "
13704|NCT02877901|"~     It is a prospective randomized- placebo control crossover study to evaluate the effect of~     long acting tolterodine (anticholinergic) in improving and treating nocturnal incontinence~     in patient after radical cystectomy and orthotopic urinary diversion. patients will be~     randomly allocated into two groups. one will receive the drug and the other will receive~     placebo. continence status will be evaluated before and 4 weeks after treatment by the~     number of pads used and the ICIQ-UI short form questionnaire. This is followed by two weeks~     of drug washout then reevaluation of the continence status and each group will be crossed~     over and lastly will be evaluated again.~   "
13705|NCT02877888|"~     Despite the availability of free health dental service in Sri Lanka, the prevalence and~     severity of dental caries among 6year old school children stand at a very high level~     according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003.~     Professional fluoride varnish application has become popular as variety of studies has found~     that it is an efficient method in reducing dental caries. The simplicity of its application~     makes it very suitable and practical for use in dental clinics and outreach dental services,~     especially in young children.~      Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium~     fluoride varnish in prevention of dental caries in permanent incisors and molars in children~     between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind,~     randomized controlled trial. A sample of school children (6-7 years) will be randomized into~     varnish and control groups. All the children will receive routine caries preventive measures~     of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish~     group will receive fluoride varnish professionally applied after prophylaxis every 6 months.~     Clinical examinations of all children will be performed at the beginning of the study and 1~     year and 2 years later. All the caries at the dentinal level of both groups will be~     stabilized with temporary restorations at the beginning. During this period, each school~     will be visited four times at 6-month interval for recruitment, dental examinations, and~     fluoride varnish applications. Recruited children will be randomly assigned to either a~     treatment (5% NaF varnish) or a control group. Caries examinations will be conducted using~     the International Caries Detection and Assessment System (ICDAS). The cost for the dental~     team's school visits; cost involved in the treatment of dental caries throughout the course~     of the study in both groups will be evaluated and compared at the end of the study. The~     sample size is calculated as 160 each arm to detect 5% caries change with 80% power.~     Analysis The effect of intervention will be measured by number of caries prevented. New~     caries in the usual care and intervention group will be calculated after the completion of~     the study. The costs for intervention will be estimated. The costs will be estimated for the~     dental material, time for human resources and indirect costs.~   "
13706|NCT02877875|"~     The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual~     school-based therapy on students' mental health and school-related outcomes, and test~     whether changes in school outcomes are mediated by changes in student mental health.~   "
13707|NCT02877862|"~     This innovative project seeks to harness mobile phone technology as a means to take~     preventive health care to a new level among ovarian cancer survivors. Using the Fogg~     Behavioral Model, developed from the concept of persuasive technology, this study proposes~     to develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to~     motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective~     is to develop and assess the feasibility and effectiveness of a theory-based intervention~     aimed to encourage ovarian cancer survivors to receive genetic counseling~   "
13708|NCT02877849|"~     Due to the relapsing nature of alcoholism, excessive alcohol consumption represents a~     significant cost to US society ($249 billion in 20101). About 64% of those entering~     treatment will relapse within one year. New interventions targeting the underlying brain~     biomarkers of relapse vulnerability hold significant promise in reducing this critical~     public health problem. Using resting functional magnetic resonance imaging (fMRI) we have~     identified brain biomarkers that support long-term abstinence and brain biomarkers that~     predict relapse. Our data point to specific brain biomarkers that index higher relapse~     vulnerability at 11 weeks of abstinence. Many individuals, however, have already relapsed by~     this time. It is unknown whether these biomarkers can be identified earlier during the~     recovery period. We need to investigate whether this biomarker of relapse vulnerability can~     be identified during earlier stages of abstinence. Earlier identification of this biomarker~     will give valuable information for timely targeted interventions (e.g. closer monitoring,~     longer stay in treatment program, neuromodulation), increasing the chances of maintaining~     abstinence. The overall objective of this study is to identify biomarkers of relapse during~     early abstinence (2-3 weeks of abstinence). A secondary objective is to evaluate whether~     non-imaging measures such as craving6 and executive function7 add value to prediction~     models. Findings from this proposal will provide insight into the neurobiology of relapse~     vulnerability that will inform new treatment strategies needed to improve treatment outcome.~   "
13709|NCT02877836|"~     The aim of this study is to evaluate the organization of the motor circuit in a group of~     patients suffering from dystonia compared with a group of healthy controls. Deep Brain~     stimulation is a functional neurosurgery technique consisting in neuromodulation of the~     motor circuit that has been applied to dystonia. The efficiency of this technique depends on~     the relative preservation of the function and the structure of the motor network .~      The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this~     study might contribute to expand our understanding of the abnormalities in motor circuit~     activation and the integrity of CNS structure underlying dystonia. This study might~     contribute therefore to the refinement of Deep brain stimulation indications and techniques~     in complex dystonia syndromes~   "
13710|NCT02877823|"~     Pediatric antipsychotic treatment is associated with significant obesity-related side~     effects, including weight gain, increased blood sugar, abnormal cholesterol, and risk of new~     onset diabetes. Antipsychotic-induced weight gain is most prominent over the first 6 months~     of treatment. In this study, youths who are started on antipsychotic medication are~     identified for a health intervention to minimize antipsychotic-induced weight gain and also~     have collateral health benefits for the child's parent. Children are identified through a~     Medicaid medication authorization program which provides a complete list of eligible youth.~     Youth-parent pairs will be enrolled. All youth and their parents enrolled in this study are~     offered healthy lifestyle education with simple targets to reduce risk of~     antipsychotic-induced weight gain (e.g. reduce sugar sweetened beverage intake, engage in 1~     hour of daily physical activity). Half of families will also receive 1) home delivery of~     bottled water, 2) provision of a child pedometer, and 3) health coaching/support from a~     telephone-delivered, parent peer program (Family Navigator). Home water delivery has been~     demonstrated to dramatically reduce sugar sweetened beverage intake in general pediatric~     studies. Child pedometers will be used to encourage parent monitoring of child physical~     activity. Parent peer support will be provided through a Family Navigator, who is a parent~     with lived experience raising a child with special mental health needs. Family Navigators~     address practical barriers to lifestyle changes for low income families (e.g. identify safe~     environment for physical activity, support access to food pantries) and provide emotional~     support for parents dealing with competing child health priorities (emotional stability,~     obesity health concerns). Family Navigator contact is exclusively by phone, and all study~     visits will occur in the home. The Family Navigators are supervised by a child mental health~     expert team, with an on-call licensed clinician available to address any after hours/weekend~     urgent concerns. The impact of this intervention will be studied on both child and parent~     health outcomes (weight, blood pressure, sugar sweetened beverage consumption), child~     physical activity, as well as parent behaviors associated with child healthy lifestyle~     changes (e.g. modeling healthy behaviors, monitoring child activity). Assessment of the~     impact of this healthy lifestyle intervention on other obesity related outcomes that are~     monitored through blood work (e.g. blood sugar, cholesterol). These labs are obtained by~     community prescribers as part of standard of care and submitted to Medicaid as required for~     ongoing approval. No blood work will be done in this study protocol. Child lab results will~     be requested from the Medicaid pre-authorization program.~   "
13713|NCT02877784|"~     Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in~     progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia~     and dysarthria. OPMD is considered a rare disease; therefore, limited research is available~     on the natural progression of the disease or the utility of biomarkers to identify~     swallowing impairment. The aim of this study is:~        1. To identify accurate, reliable and non-invasive clinical markers of swallowing~          impairment~        2. To determine the discriminate ability of these markers to identify impairments in~          swallow safety and swallowing efficiency.~   "
13714|NCT02877771|"~     The goal of this study is to assess the functionality of an integrated predictive low~     glucose suspend system designed to minimize the incidence and duration of hypoglycemia by~     suspending insulin delivery if hypoglycemia is projected.~   "
13715|NCT02877758|"~     Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging~     skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can~     reduce the visible signs of cutaneous aging.~   "
13716|NCT02877745|"~     In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary~     artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative~     atrial fibrillation and complications will be assessed. The primary objective is to~     determine, whether SDB patients have a higher rate of Major Adverse Cardiac and~     Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.~   "
13717|NCT02877732|"~     This is a prospective multi-center cohort feasibility and exploratory study.~   "
13718|NCT02877719|"~     The aim of this study is to explore the impacts of poverty and income disparity on the~     psychological well-being of Hong Kong Chinese children.~   "
13719|NCT02877706|"~     CARMEN is a clinical registry of all incident adult Immune thrombocytopenia (ITP) patients~     in the Midi-Pyrenees region (South of France). It is aimed at describing ITP clinical~     features, assessing several second-line treatments (SLTs) benefit-to-risk balance and~     adherence to guidelines for ITP management.~   "
13720|NCT02877693|"~     to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in~     patients undergoing an elective thoracic MRI scan.~   "
13721|NCT02877680|"~     Type 1 diabetes (T1D) management is particularly challenging during adolescence as~     responsibility for management begins to shift from parents to youth, and positive family~     teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family~     interventions for T1D are beneficial but have limited potential for translation to clinical~     practice, and universal preventive approaches designed to explicitly promote existing T1D~     management strengths are needed. Ultimately, the goal of this line of research is to~     validate brief, convenient, and helpful tools that families of all adolescents with T1D can~     use to strengthen positive family teamwork and ultimately promote optimal diabetes health~     outcomes.~   "
13722|NCT02877667|"~     Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.~   "
13723|NCT02877654|"~     Increased intestinal permeability is one of the main pathophysiological mechanisms involved~     in irritable bowel syndrome. The expression of some intestinal tight junction proteins is~     decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased~     intestinal permeability. Currently, no test used in clinical practice could assess~     intestinal permeability.~      We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.~   "
13724|NCT02877641|"~     This phase IIb randomized trial studies how well cholecalciferol (vitamin D3)~     supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient~     patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation~     may help reduce the risk of developing lung cancer and strengthen the diaphragm in~     cholecalciferol-deficient patients with COPD.~   "
13725|NCT02877628|"~     Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic~     monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be~     communicate to clinicians or patients during the study.~   "
13726|NCT02877615|"~     The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing~     functional recovery after an ischemic stroke.~   "
13727|NCT02877602|"~     This is a qualitative study to determine which factors affect the patient experience of~     having a liver MRI, what information patients would like to receive after their MRI, and how~     patients would like this information communicated to them.~   "
13728|NCT02877589|"~     Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV)~     and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but~     can cause fulminant hepatitis and death. More, they impact the treatment of cancer by~     chemotherapy delays or stops. They can occur during cancer treatment but also after~     stopping, at the immunological rebound. This risk persists for at least 6 months after~     cessation.~      The key to the prevention, and the first step, is serological testing. It is also the main~     problem because international recommendations diverge. Hepatologists and infectious disease~     specialists recommend routine screening HBV of all candidates for immunosuppressive therapy.~     These recommendations are more implemented by hematologists, given the frequency of HBV~     reactivation associated to haematological malignancies. Clinical oncology societies~     guidelines suggest a selective screening in case of risk factors of hepatitis B or in~     patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell~     transplantation or lymphoma treatment).~      The consequence of these differences is a sub-screening by oncologists and the persistence~     of fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with~     low prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk~     HBV and HCV can be assessed.~   "
13729|NCT02877576|"~     The purpose is to evaluate specific capacities of face detection of individual neurons by~     comparison with their capacity of object detection in medial temporal lobe and ventral~     temporal cortex in epileptic patients.~      Secondary purpose is to evaluate specific capacities of detection of known faces of~     individual neurons by comparison with their capacity of detection of unknown faces in medial~     temporal lobe and ventral temporal cortex in epileptic patients.~   "
14280|NCT02870387|"~     The investigators will conduct a pilot quality improvement trial to assess the impact of~     offering inpatient consultation to further optimize coordination and improve care for~     high-risk chronically ill children receiving comprehensive care in an enhanced medical home.~   "
13730|NCT02877563|"~     This study represents an important step to validate the use of contrast-enhanced ultrasound~     (CEU) as a clinical research tool that can be used as a biologic readout of new therapies~     for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing~     impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging~     can be used to accurately assess therapeutic improvements in tissue perfusion that are~     linked to symptom improvement.~   "
13731|NCT02877550|"~     Follicular lymphoma (FL) is an indolent yet incurable lymphoma characterized by initial~     responses to standard therapies, invariably followed by shorter disease free intervals.~     Obinutuzumab, a novel type II, anti-CD20 monoclonal antibody has been approved in~     combination with chlorambucil for the treatment of previously untreated chronic lymphocytic~     leukemia (CLL) and in combination with bendamustine followed by obinutuzumab alone for FL~     who did not respond to, or who progressed during or after treatment with rituximab or a~     rituximab-containing regimen, or in relapse after such treatment. Additionally, venetoclax,~     a small molecule Bcl-2 inhibitor, showed single agent activity in relapsed/refractory (R/R)~     CLL and other B-cell lymphomas, including R/R FL. Preclinical evidence suggests a synergism~     of the two drugs in vitro as well as in different lymphoma in vivo models. Based on single~     agent clinical activity and on the preclinical data of the combination of both drugs and~     aiming to develop a new chemotherapy-free combination regimen, this trial plans to evaluate~     the combination of obinutuzumab and venetoclax in previously untreated FL patients in need~     of systemic therapy. This phase I study will provide information on the safety and~     tolerability together with evidence of preliminary antitumor activity. Combination treatment~     consists of a 6 cycles of 28 days each. The combination therapy is followed by a 2 years~     maintenance with obinutuzumab. Dosing of obinutuzumab is as per Swissmedic approval in~     FL.Venetoclax will be administered in different dose levels according to the trial design.~   "
13732|NCT02877537|"~     The purpose is to characterize the change of respiratory admittance induced by salbutamol~     inhalation in children and young adults. A variation threshold will be fixed to distinguish~     asthmatic and healthy subjects.~      This project could allow a better identification of asthmatic individuals needing a~     treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments~     administered in individuals with respiratory but not asthmatic symptoms, a better~     comprehension of bronchial hyperreactivity and its role in asthmatic disease.~   "
13733|NCT02877524|"~     The clinical course of chronic obstructive pulmonary disease (COPD) is associated with~     recurrent episodes of exacerbation that results in respiratory failure. The treatment of~     respiratory failure is supportive and involves inhalation bronchodilators along with~     systemic steroids. In few cases the management of acute respiratory failure requires~     positive pressure ventilation (non-invasive or invasive). The use of NIV in acute~     exacerbation of COPD has resulted in significant reduction in morbidity and mortality.~     Although pressure support ventilation (PSV) allows the patient to influence the breathing~     pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and~     severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. Adaptive support~     ventilation (ASV) is a newer mode of ventilation that incorporates feedback mechanisms and~     thus provides a stable minute ventilation. We hypothesize that the use of ASV as a mode~     during ventilation using NIV in patients with acute exacerbation of COPD may result in~     reducing the duration of ventilatory support, need for intubation, and duration of intensive~     care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.~   "
13734|NCT02877511|"~     To assess the safety of a sunscreen product under supervised outdoor-use conditions~   "
13735|NCT02877498|"~     Neuroparalytic snake envenomation results in severe muscle weakness and respiratory failure.~     Treatment requires administration of anti-snake venom and supportive care in the form of~     invasive mechanical ventilation. Whether using adaptive support ventilation (a closed loop~     mode of ventilation) in comparison to volume controlled ventilation will shorten the~     duration of ventilation remains undetermined. The current study is planned to compare~     adaptive support ventilation (ASV) mode of ventilation versus volume controlled ventilation~     (VCV) during invasive mechanical ventilation for the management of respiratory failure~     secondary to neuroparalytic snake envenomation.~   "
13736|NCT02877485|"~     The purpose of this project is to determine if intranasal corticosteroids have an effect on~     nasal obstruction in patients with nasal septal deviation.~   "
13737|NCT02877472|"~     To confirm 1) whether, compared with core decompression alone, core decompression with~     porous tantalum rod implantation improves the hip joint function of patients with avascular~     necrosis of the femoral head after femoral neck fracture surgery, 2) whether porous tantalum~     rod shows favorable biocompatibility with the human body, and 3) whether this treatment~     method is feasible for treating avascular necrosis of the femoral head after femoral neck~     fracture surgery.~   "
13738|NCT02877459|"~     A multicenter, prospective, single-arm clinical investigation to evaluate the short term and~     long term safety of a modified staged treatment algorithm using the AeriSeal System.~   "
13739|NCT02877446|"~     Chronic heart failure is a common disease. It is also a serious disease with a mortality of~     50% at 5 years, representing a significant cost in terms of public health expenditure.~      Heart transplantation represents the gold standard of care for terminal heart failure~     patients reached the end of the disease despite optimal medical and surgical management of~     their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3~     years.~      Long term LVAD are an innovative technology available for more than a decade, developed in~     part because of the shortage of cardiac grafts and high mortality among patients waiting for~     transplants due to an important pending.~      This technique is used substantially only for ten to fifteen years in the world. Survival~     after implantation of latest devices reaches 80% at 1 year.~      In France, this technique is intended for patients with terminal heart failure who ended~     different pharmacological and invasive therapeutic resources available.~      Currently, academic centers that offer the possibility of long-term LVAD support are~     organized unicentric in order to centralize specialized care for these patients.~      Indeed, patients candidates for the establishment of a long-term LVAD are rigorously~     selected to ensure an acceptable survival.~      However, practices vary considerably from one center to another in particular regarding:~        -  Implantation indications,~        -  Pre-implantation patient assessment,~        -  Monitoring,~        -  Implementation of pharmacological treatments, particularly anticoagulants or~          betablockers.~   "
13741|NCT02877420|"~     The investigators aim to test a curriculum of non-technical skills (NTS) training for~     simulation-based training of colonoscopy. There is no known literature to date on the~     optimal approach on how to teach NTS in endoscopy. The objectives are to evaluate a~     simulation-based curriculum to teach NTS, to explore the relationship between NTS and other~     domains of competency, and understand how NTS are acquired in endoscopic training.~   "
13742|NCT02877407|"~     -  objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal~          hysterectomy for uterine prolapse~        -  prospective randomized clinical trial~        -  patient~             1. 60yrs or more women and~             2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom~        -  number of patient: 146~        -  randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy~        -  follow up: postoperative 1 year~        -  primary endpoint: recurrence rate~             1. recurrence of uterovaginal prolapse POP-Q stage II-IV~             2. recurrence of associated symptom~        -  secondary endpoint~             1. postoperative 1 year QOL, degree of satisfaction evaluation~             2. operative time, estimated blood loss~             3. hospitalization period, postoperative pain, return to normal activity~   "
13743|NCT02877394|"~     Constipation is a very common problem. Western style toilets that are nearly universal in~     the United States require the person to sit on the toilet. However, results from~     uncontrolled studies suggests that a squatting posture (as prevalent in many foreign~     countries) may be better at facilitating evacuation compared to a Western style commode. One~     uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly~     98% of 153 constipated participants. Hence, the investigators propose to evaluate the~     benefits of a footstool on symptoms and anorectal functions in constipated patients.~     Hypothesis: the regular squatting assist device (7 inches) but not a sham device (2 inches~     tall) will improve symptoms of constipation.~   "
13744|NCT02877381|"~     To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA)~     [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral~     repeated dosing] to minimize post-operative blood loss and transfusion requirements~     following revision total knee arthroplasty (RTKA).~   "
13745|NCT02877368|"~     The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the~     arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly~     targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor.~     Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is~     generally well-tolerated and known to improve performance status but up to 16% grades 3-4~     toxicities, leading to at least 40% withdrawals, have been reported.~      Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients~     included in phase 1 trials, suggesting that it should be considered an inclusion criterion~     for such studies. Sarcopenic patients had low performance status, shorter survival, more~     chemotherapy toxicities and post-operative infections, and longer post-operative~     hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib~     or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal~     cell or hepatocellular carcinomas.~      Computed tomography (CT) scans acquired during routine care have been validated as an~     accurate and robust imaging technique to evaluate sarcopenia in cancer patients.~   "
13746|NCT02877355|"~     This trial is conducted in Europe. The aim of this trial is, to investigate the effect of~     upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in~     the body) of oral semaglutide in subjects with type 2 diabetes.~   "
13747|NCT02877342|"~     A prospective observational study using an interrupted time-series design to evaluate the~     effect of pre-hospital notification on trauma patients arriving at a trauma centre by~     ambulance, in India~   "
13748|NCT02877329|"~     Randomized trial comparing internet-delivered ACT with therapist support against waiting~     list for persons with hearing loss and comorbid psychological distress~   "
13749|NCT02877316|"~     Background: Persons with a past episode of self-harm or severe suicidal ideation are at~     elevated risk of self-harm as well as dying by suicide. It is well established that suicidal~     ideation fluctuates over time. Safety plans in paper format are mandatory part of the~     treatment regime in the suicide preventive clinics in Denmark. The aim of the trial is to~     compare the paper version of the safety plan with a new-developed app in reducing suicide~     ideation and other symptoms, as an add-on to the supportive psychotherapy delivered in the~     clinics.~      Hypothesis: It is hypothesized that participants randomized to MYPLAN will have lower~     suicide ideation as well as improvements on the secondary outcomes than users who have the~     paper version.~      Methods: The trial is designed as a 2-arm observer-blinded parallel group randomized~     clinical superiority trial, where participants will either receive: 1) Experimental~     intervention: the safety plan provided as the app MYPLAN, or 2) Treatment as Usual: the~     safety plan in the original paper format. Both intervention groups will also receive~     standard psychosocial therapeutic care, up to 8-10 sessions of supportive~     psychotherapy.Based on a power calculation a total of 546 participants, 273 in each arm will~     be included. They will be recruited from national suicide preventive clinics. Follow-ups~     will be conducted at 3, 6, 9, and 12 months after date of inclusion.~      Participants, inclusion and exclusion criteria: There is no age restriction on participation~     in the study and all participants will be recruited from the suicide prevention clinics in~     Denmark. These clinics are highly specialized outpatient care centers, offering short-term~     supportive psychotherapy and social counselling for suicidal patients. In order to~     participate in the study, participants must have a smartphone (IPhone or android phone) and~     understand sufficient Danish to use MYPLAN. Persons having a particularly severe alcohol or~     substance abuse disorder, which might inflict with skills of orientation and memorywill not~     be offered participation in the RCT.~      Outcomes Patient reported outcomes (PROM) are collected at baseline and follow-up through~     self-administered tablet/internet-based questionnaires. Primary outcome is suicide ideation.~     Secondary outcomes are:, hopelessness, depressive symptoms, quality of life, and modified~     CSQ-8.~      Statistical analysis: Data analysis will be based on intention-to-treat principle. We will~     examine this using repeated measurement in mixed models. Missing data will be handled with~     multiple imputations.~      The trial will start in November 2016 and patient recruitment is expected to finish November~     2017. Analysis and results are expected in 2018.~   "
13750|NCT02877303|"~     The goal of this clinical research study is to learn if Blinacyto (blinatumomab), when given~     after Hyper-CVAD, can help to control newly diagnosed B-Cell Lineage ALL. The safety of this~     drug will also be studied.~   "
13751|NCT02877290|"~     In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance~     cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one~     without in a randomized cross-over design. The aim is to measure, whether NIV is able to~     change peripheral and respiratory muscle oxygenation.~   "
13752|NCT02877277|"~     This study evaluates whether vitamin C improves responses to epigenetic therapy with DNMTis.~     Half of the patients will receive vitamin C and DNMTi while the other half will receive~     placebo and DNMTi.~   "
14281|NCT02870374|"~     The project team developped and validated a French patient-based health-related quality of~     life instrument in kidney transplant: the QoL Retrans.~      The aim of the study is to determine the minimum significant change of the valdiated tool:~     ReTransQol~   "
13753|NCT02877264|"~     This is a randomized, single-center, open-label, three-period, six-sequence, crossover,~     comparative study to evaluate the oral bioavailability of single doses of three vapendavir~     drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral~     suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy~     volunteers. The study design consists of six dosing sequences. Each sequence comprises 3~     periods and each subject is administered one of the three dosing formulations in the first~     period. A subject receives a different formulation in each of the subsequent periods, so~     that all subjects receive each formulation. The periods are separated by an approximate~     7-day washout.~   "
13754|NCT02877251|"~     REMMITE, a retrospective and prospective registry with one-year follow-up, will provide~     valuable insights into the clinical diagnosis, management, treatment trends as well as~     related outcomes of three cohorts: DVT, DVT-PE, PE patients throughout many regions of~     Mexico and through different health care systems.~   "
13755|NCT02877238|"~     Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may~     mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.~   "
13756|NCT02877225|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of~     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.~   "
13757|NCT02877212|"~     Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by~     antibody-mediated platelet destruction. The complex pathogenesis of ITP with multiple~     challenges to immune system in terms of genetic predisposition, infection, responsiveness to~     immunosuppressive therapy (IST) and inhibition of platelet production has proven the~     diversity of constraints in diagnosing and treating ITP. Thrombopoietin receptor agonist~     (Eltrombopag) is specifically indicated for the treatment of thrombocytopenia in patients~     with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient~     response to corticosteroids, immunoglobulins, or splenectomy. This clinical trial aims to~     investigate the association of Fc gammaRIIIA gene (V158F) genetic predisposition with~     treatment outcome of Immune Thrombocytopenia (ITP) in refractory ITP patients and especially~     with Eltrombopag.~   "
13758|NCT02877199|"~     The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the~     on-treatment viral kinetics and could predict virological outcome in treatment-experienced~     HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.~   "
13759|NCT02877186|"~     This pilot study is being conducted to evaluate whether consumption of diet soda sweetened~     with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a~     one week run-in period, healthy, young adults are randomized to consume either diet soda or~     carbonated water (control) three times per day for one week. Stool and urine samples are~     collected at baseline, following the run-in, and after the one-week intervention.~   "
13760|NCT02877173|"~     A phase II,randomized,double-blind,multi-doses,positive drug parallel~     controlled,multi-center clinical trial to evaluate initially the efficacy and safety of~     alprostadil liposomes for injection in the treatment of atherosclerotic occlusive disease of~     the lower extremities.~   "
13761|NCT02877160|"~     This study is a single-center, randomized, open-label crossover study to assess the~     pharmacokinetics and food effect of AL-794 formulations in healthy subjects.~   "
13762|NCT02877147|"~     The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to~     households with school-aged children during the summer through electronic benefit transfer~     (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special~     Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The~     evaluation design included two components: an impact study and an implementation study. The~     evaluation assessed the impact of SEBTC on children's food security and nutritional status,~     household food expenditures and purchasing behaviors, parental perceptions, and~     participation in nutrition assistance programs. The implementation study analyzed SEBTC use~     patterns using administrative data, and described demonstration implementation and costs.~   "
13763|NCT02877134|"~     The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in~     participants with moderately to severely active Crohn's disease.~   "
13764|NCT02877121|"~     The purpose of this study is to assess the Respiratory Muscle Function and Neural~     Respiratory Drive in Interstitial Lung Disease patients.~   "
13765|NCT02877108|"~     There is limited information on the best psychoactive medication to treat agitated patients~     in the emergency department. The intent of this study is to fill in knowledge gaps in the~     current practice of treating psychiatric patients in the acute care setting. The purpose of~     this study is to determine the best treatment for agitated psychiatric patients in the~     emergency department.~   "
13766|NCT02877095|"~     The Pilot study is designed to evaluate the overall safety and feasibility of a strategy~     based on subcutaneous delivery of furosemide. It will be used to inform the subsequent~     evaluation phase of the study (separate protocol). The primary objective of the study is to~     determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible~     in patients with acute heart failure.~   "
13767|NCT02877082|"~     This phase II trial studies how well tacrolimus, bortezomib, and anti-thymocyte globulin~     (thymoglobulin) work in preventing low toxicity graft versus host disease (GVHD) in patients~     with blood cancer who are undergoing donor stem cell transplant. Tacrolimus and~     anti-thymocyte globulin may reduce the risk of the recipient's body rejecting the transplant~     by suppressing the recipient's immune system. Giving bortezomib after the transplant may~     help prevent GVHD by stopping the donor's cells from attacking the recipient. Giving~     tacrolimus, bortezomib, and anti-thymocyte globulin may be a better way to prevent low~     toxicity GVHD in patients with blood cancer undergoing donor stem cell transplant.~   "
13768|NCT02877069|"~     This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA)~     injectable gel for filling fine lines, as measured by skin texture improvement, and for~     improvement of skin quality.~   "
13769|NCT02877056|"~     The goal of this laboratory research is to look for genes that can predict which patients~     will achieve a complete disappearance of their colorectal cancer after treatment like~     chemotherapy, radiation, or other therapy.~   "
21505|NCT02775695|"~     This is a window-of-opportunity study that examines the efficacy of doxycycline, and~     FDA-approved oral antibiotic, on metakaryotic (cancer stem cells) in resectable pancreatic~     cancer following eight weeks of treatment.~   "
13770|NCT02877043|"~     In 2009, centres that carried out lung resection for cancer were required to obtain~     authorization following the first cancer plan. One of the criteria to obtain authorization~     was the volume of activity: the centre had to carry out at least 30 lung resections per year~     for cancer. Five years later, it would be useful to know the impact of this new organization~     of oncology on the quality of care. To answer this question, the PMSI database is an ideal~     source of an indicator of quality: in-hospital mortality. This observational cohort study~     will be conducted using the national PMSI database with data covering the period from 1st~     January 2005 to 31st December 2013. It will be limited to hospitalization for lung~     resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the~     period 2008-2010 includes the implementation of authorizations for cancer surgery.~   "
13771|NCT02877030|"~     Testing the effectiveness of an exercise protocol engines sensory performed through a~     virtual reality platform in individuals infected with HTLV-1~   "
13772|NCT02877017|"~     Miscommunications are a leading cause of serious medical errors in hospitals, contributing~     to more than 60% of sentinel events, the most serious adverse events reported to the Joint~     Commission. Efforts to improve patient safety in hospitals have centered on improving~     communication between providers. While provider-focused communication interventions have led~     to reductions in patient harm, patients and families have been notably absent from most~     interventions to improve patient safety. This proposal seeks to develop and investigate the~     effectiveness of a family safety engagement intervention aimed at reducing harm in~     hospitalized children.~   "
13773|NCT02877004|"~     The purpose of this research is to gather preliminary information on the effectiveness of~     Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central~     body region.~   "
13774|NCT02876991|"~     The purpose is to evaluate if sodium fluoride PET in patients having already undergone a~     choline PET negative for bone extension (non-metastatic status) modifies the status of~     patients concerning the existence or not of bone metastases.~      Secondary purposes are:~        -  To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by~          choline PET, leads to change of treatment~        -  To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results~          (metastatic status and number of lesions)~        -  To evaluate the inter-judge concordance of interpretation of sodium fluoride PET~        -  To study the discordance of metastatic status of 2 techniques.~   "
13775|NCT02876978|"~     The purpose of this study is to observe and confirm the safety, tolerance and cell~     pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)~   "
13776|NCT02876965|"~     This study evaluates the effect to a muscle stretching program combined with physical~     exercise versus a physical exercise program in patients with fibromyalgia.~   "
13777|NCT02876952|"~     Acute myocardial infarction (MI) continues remains to be a major cause of death and~     disability worldwide. Exercise therapy has long been used for rehabilitation purposes and~     the benefit of regular physical exercise is also well established. The intensity of aerobic~     exercise training is a key issue in cardiac rehabilitation programmes.Endurance aerobic~     training is typically performed as continuous training at moderate to-high exercise~     intensity in steady-state conditions of aerobic energetic yield. However, interval training~     (i.e., repeated bouts of short-duration, high to severe- or severe to extreme-intensity~     exercise, separated by brief periods of lower-intensity) has been proposed to be more~     effective than continuous exercise for improving exercise capacity. Adding to that,~     health-related adaptations to low-volume and high intensity interval training have been~     presented.~      On the other hand, the Mediterranean Diet has been widely reported to be a model of healthy~     eating for its contribution to a favourable health status and a better quality of life,~     reducing in overall mortality from cardiovascular diseases.~      Considering all the above mentioned in MI population, the principal objective for the~     INTERFARCT study will be to assess the effects of different programs of high intensity~     aerobic interval training and Mediterranean Diet recommendations in the clinical condition,~     cardio-respiratory fitness, biomarkers, ventricular function and perception of quality of~     life after myocardial infarction.~      Methods/Design: One hundred and fifty people after suffering acute MI will perform different~     assessments to evaluate clinical history, physical, biochemical and nutritional condition,~     and quality of life before and after 16-week of follow-up. All participants will receive~     Mediterranean diet recommendations and will be randomly assigned to attention control group~     (diet and physical activity recommendations) or exercise groups (diet recommendations plus~     high-intensity aerobic interval exercise). Participants assigned to an exercise group will~     train 2 days/week under supervision (day 1-treadmill and day 2-bike protocol). There will be~     two aerobic exercise groups: 1) high-intensity interval training and high-volume (HV-HIIT)~     group, and 2) high-intensity interval training and low-volume (LV-HIIT) group.~   "
13778|NCT02876939|"~     This project comprises three sets of physiological studies - testing eight specific~     hypotheses - that will contribute new knowledge on proprioception and motor control in a~     genetic disorder that affects specific components of the sensory nervous system.~      I: To investigate the neurophysiological basis for disturbed motor control in Hereditary~     sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing~     cutaneous feedback on motor control in HSAN III III: To investigate the cortical~     representation of proprioceptive inputs in HSAN III~   "
13779|NCT02876926|"~     This study explores whether offering follow-up counseling and referral over the phone after~     using a home-based HIV test increases rates of ever and repeat testing, compared with~     home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based~     testing.~   "
13780|NCT02876913|"~     The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the~     surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are~     often not fitted in anatomy of Korean people because of small nostril. When the size of the~     tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the~     glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube~     and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who~     are scheduled for nasal intubation for general anesthesia will be enrolled. The primary~     outcome is the proportion of patients who are in inappropriate insertion of nasotracheal~     tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of~     nostril, length from the nare to the carina and vocal cord are measured.~   "
13781|NCT02876900|"~     This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo~     transdermal patch in subjects diagnosed with schizophrenia.~   "
13782|NCT02876887|"~     The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months~     improves walking performance in individuals with peripheral artery disease compared to~     placebo.~   "
13783|NCT02876874|"~     To observe the relationship between the activity of rheumatoid arthritis and~     popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial~     lymphatic vessels~   "
21506|NCT02775682|"~     The purpose of this study is to determine whether patients with epilepsy exhibiting impaired~     dCA, which may contribute to subsequent stroke.~   "
13785|NCT02876848|"~     Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine~     therapy (AET) is associated with a significant survival advantage. Nonadherence is a~     particular challenge in older women, even though they stand to benefit the most from AET.~     Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health~     administrative claims data was developed to provide point-of-care decision support for~     clinicians.~   "
13786|NCT02876835|"~     The purpose of this multi-center event-driven study in non-dialysis (ND) participants with~     anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy~     of daprodustat compared to darbepoetin alfa.~   "
13787|NCT02876822|"~     The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy~     among HSCT patients in a tiered, step-wise manner (step one/two) in order to define~     treatment doses capable of providing vitamin D sufficiency.~   "
13788|NCT02876809|"~     This study evaluates the associations between biomarkers of ageing, comprehensive geriatric~     status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA~     metagenome sequencing in Moscow centenarians.~   "
13789|NCT02876796|"~     The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976~     (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose~     administration in overweight and/or obese, but otherwise healthy, male adults.~   "
13790|NCT02876783|"~     Observe and describe the relationships between impairments and function, systematically~     characterize recovery patterns and examine short and long term rehabilitation outcomes. This~     project is purely observational, descriptive and non-experimental. N=273~   "
13791|NCT02876770|"~     The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion~     upon short-term performances, on the following morning. Twelve soccer players from a~     Tunisian squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform~     three testing sessions, with one test session per day. During each session, MEL (5mg) , MEL~     (8mg) or placebo were ingested, in a randomized order, before nocturnal sleep. The next~     morning (08:00h), participants performed the following psycho-cognitive and physical tests:~     Hooper's index, reaction time, vigilance, handgrip strength , squat jump , modified agility~     test , Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of~     perceived exertion was recorded immediately after the WanT, and blood lactate measures were~     taken after 3min of recovery. Blood glucose was measured before and 3 min after the Wingate~     test.~   "
13792|NCT02876757|"~     In December 2015, Health Canada issued a warning about a potential relationship between~     suicide and finasteride use and called for further research. No population based studies~     have assessed the risk of suicide with finasteride use, and this risk is not currently part~     of the product monograph. Furthermore, the link between depression and finasteride has not~     been well studied in the older population who are the primary users of this medication.~   "
13793|NCT02876744|"~     The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long~     term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy.~     The accuracy of the analysis of the vascularization of retinal layers of the posterior pole~     of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not~     there are areas of macular ischemia in a patient. However, current technical limitations~     (small field analysis) of OCT-A imaging only allow a limited study of retina at the~     posterior pole of the fundus.~      This study seeks to demonstrate whether there is a link between macular ischemia detected by~     the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in~     diabetic patients.~   "
13794|NCT02876731|"~     Prospective, monocentric, comparative, non randomised~      Primary objective :~      - to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the~     conventional block and diffusion sequence in the search for bone metastases~      Secondary objectives :~        -  compare accuracy of MRI diffusion and conventional MRI~        -  explore the evolution of the results of the different types of imaging over time or~          under treatment for patients with repeated examinations at 6 months~   "
13795|NCT02876718|"~     The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation~     (NVAF) patients towards different options of an anticoagulation treatment.~      Patient preferences for anticoagulant treatment attributes (convenience attributes only),~     based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of~     switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient~     treatment satisfaction will be documented, measured by score differences of the Anti-Clot~     Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.~   "
13796|NCT02876705|"~     The purpose of this study will be to study the individual spatiotemporal structure and~     dynamics of topologically defined areas of perceived body discomfort and pain during~     exercise. Participants will perform two constant tests (cycling and running) at an intensity~     corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e.,~     hard). Using a body map template, participants will report every 15s the perceived locations~     with discomfort and pain independently of the magnitude of the discomfort and pain.~   "
13797|NCT02876692|"~     This is a prospective cohort study:~        1. First step: to establish a new scoring system for predication of delayed graft~          function(DGF) following kidney transplantation based on previous and new study data.~          The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring~          system and kidney evaluation System based on Lifeport platform ).~        2. Second step: validate the new scoring system through prospective cohort study in our~          transplantation center and modify the scoring system if needed. Recruiting 300~          patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients~          will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR),~          graft survival and patient survival~        3. Step 3: Further validate the new scoring system in six other transplantation centers~          and developing a software in the end. Recruiting 300 patients, follow up at day 3, week~          1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,~          PGF, AR, graft survival and patient survival~   "
13798|NCT02876679|"~     The study is designed as a two arm randomized Phase II, multicenter trial comparing~     cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis~     in patients with hematologic malignancies undergoing reduced intensity conditioning~     hematopoietic stem cell transplantation.~   "
13799|NCT02876666|"~     The SCI Virtual Coach study has developed an on-screen, human-like character that will~     provide support, education and coaching to adults with spinal cord injury (SCI) to aid in~     the prevention of serious secondary conditions like pressure ulcers. In a randomized~     controlled trial, participants assigned to the Coach intervention will have a touch-screen~     computer placed in their homes and be asked to interact with the Coach on a daily basis for~     2 months. Participants will be asked to complete surveys at baseline and 2 months.~      The SCI Virtual Coach study aims to measure how accessible and usable participants feel the~     Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge~     how effective the Coach is in changing self-care knowledge, health care behaviors,~     self-efficacy for self-care, and perception of social support in participants.~   "
13800|NCT02876653|"~     Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can~     lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is~     difficult because of associated risk factors (diabetes, hypertension, dyslipidemia,~     obesity), promoting themselves aging. The investigators propose to compare a group of OSAS~     patients free of any associated pathology, to subjects matched for age, sex, smoking and~     body mass index (BMI)~   "
13801|NCT02876640|"~     This phase Ib trial studies how well retinoid 9cUAB30 works in producing a biologic effect~     in patients with early stage breast cancer. Chemoprevention is the use of drugs to keep~     breast cancer from forming or coming back. The use of retinoid 9cUAB30 may slow disease~     progression in patients with early stage breast cancer.~   "
13802|NCT02876627|"~     Introduction: The purpose of this study was to determine the effect of twelve weeks of~     aerobic exercise program on erythrocyte levels in women with breast cancer after~     chemotherapy.~      Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged~     between 47-65 years) volunteered for this study, and then randomly selected an exercise (n =~     15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise~     training program consisted of three sessions per week, each session lasting 30 to 60 minutes~     50 to 75 percent of their maximum heart rate reserve, while the control group were followed.~     Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak~     oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis~     of data, repeated-measures analysis of variance (ANOVA) was used.~   "
13803|NCT02876614|"~     Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal~     injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for~     two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of~     normal pressure hydrocephalus.~      In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF~     unlike other reference tests.~      In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and~     throat of the patient to collect a possible flow of CSF.~      These samples are analysed by radioactivity measurements and bring an added value to the~     exam.~      The interest of this examination for management of CSF leak/fistula remains unclear.~      The aim of this study is to identify and analyse results of all RC examinations performed~     since 2005 in the Nuclear Medicine department of the Neurological Hospital.~      The full analysis of patients will allow discussing the role of RC in management of CSF~     leak/fistulae in clinical practice.~   "
13804|NCT02876601|"~     Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of~     veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact~     mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will~     be investigated in the human endotoxemia model in order to gather further information on its~     actions.~   "
13805|NCT02876588|"~     Currently, at least 70,000 U.S. physicians use computerized provider order entry (CPOE) to~     place orders. This number is expected to rise sharply as hospitals continue to take~     advantage of federal incentives and adopt electronic health record (EHR) technology.~     Although CPOE is associated with a reduction in medical errors, when orders are placed~     electronically certain types of errors, including placing orders on the wrong patient, may~     occur more frequently. The mechanism by which multiple patient records opened simultaneously~     can lead to wrong-patient errors may be related to the ease with which users can toggle~     between patient records and the similar looking computer screens. The magnitude of this risk~     needs to be established to help Health Information Technology (IT) leadership decide how to~     safely implement CPOE systems. There have been no studies demonstrating whether multiple~     records increase the risk of wrong-patient errors, by how much, and if any increase is~     dependent on the number of records open. This research project is an important first step in~     quantifying this risk.This will be the first study to achieve the following aims:~        1. Assess the relationship between the number of records open at the time of placing an~          order and the risk of placing an order on the wrong patient.~        2. Compare the incidence of wrong-patient orders in a restricted environment that limits~          providers to only one record open at a time to an unrestricted environment where~          users can open a maximum of four records at once.~        3. Use results to inform a larger-scale health IT implementation research project~          evaluating the balance between the wrong-patient error risks and potential efficiency~          gains of having multiple records open at once, with rigorous research methodologies.~        4. Disseminate results to help inform decisions on how to safely implement EHR systems.~   "
13806|NCT02876575|"~     The purpose of this study is to assess the severity of post-operative pain following the use~     of the BiZact™ device in adult (≥22 years of age) tonsillectomy procedures.~   "
13807|NCT02876562|"~     Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for~     augmenting keratinzed gingiva , improved wound healing, recession coverage in localized~     gingival recessions and multiple recession coverage.~      However there are very few randomized controlled clinical trials in the literature that~     compare collagen matrix versus connective tissue graft in the management of multiple~     recession type defects. To the best of our knowledge there is only one randomized controlled~     trial that compares modified coronally advanced tunnel+connective tissue graft with collagen~     matrix in the management of multiple gingival recessions.~      Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the~     management of Millers class I and II multiple gingival recessions. The use of collagen~     matrix in combination with Modified Coronally Advanced Tunnel as a surgical technique will~     be compared for recession coverage.~   "
13825|NCT02876328|"~     The purpose of this study is to evaluate the safety and immunogenicity of three vaccine~     strategies that may prevent Ebola virus disease (EVD) events in children and adults.~     Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA)~     boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.~   "
13826|NCT02876315|"~     Many older adults do not get enough zinc, vitamin C and vitamin D, and this can be related~     to decreased ability to fight infection. The purpose of this research study is to determine~     if taking a multivitamin/mineral supplement every day for 12 weeks will increase the ability~     of immune cells in blood to kill bacteria.~   "
13808|NCT02876549|"~     This will be a single-arm observational cohort study. Malaria patients with Plasmodium vivax~     and meeting study inclusion criteria, who give consent to be enrolled in the study, will~     have their G6PD status measured by the CareStart™ G6DP rapid diagnostic test (G6PD RDT), and~     primaquine prescribed according to the result. According to the G6PD RDT result, primaquine~     will be prescribed at 0.25mg/kg/day for 14 days (normal patients) or 0.75mg/kg weekly for~     eight weeks (deficient patients). All will receive treatment with chloroquine to clear~     asexual stages of infection.~      Patients will be reviewed at day 2, day 7 and day 14. At these visits patients will undergo~     a brief clinical assessment and a small blood sample will be taken for repeat haemoglobin~     measurement and dried blood spot for carboxyprimaquine measurement (day 7 and day 14 only).~      In general, antimalarial treatment will be unsupervised to reflect field conditions. However~     a subset of 25 G6PD normal patients at a single site will have each day of their primaquine~     treatment administered and observed at the treatment centre. This is to determine a~     calibration curve for primaquine pharmacokinetic studies.~      Dried blood spots will be stored appropriately. Day zero samples will be genotyped in~     Bangkok (MORU, Dr. Mallika Imwong) after DNA extraction. PCR-RFLP will be used to detect the~     allele associated with the Mediterranean variant of G6PD deficiency. In addition DNA~     extracts will be sent for more systematic genetic testing for known G6PD variants through~     existing collaborations with the Wellcome Trust Sanger Institute. The day 7 and 14 dried~     blood spot samples will be analysed in the MORU pharmacology laboratory for primaquine and~     carboxyprimaquine concentrations, from which adherence to primaquine can be determined~     retrospectively, using the subset of 25 patients receiving directly observed therapy to~     calibrate the results.~   "
13809|NCT02876536|"~     The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation~     (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.~   "
13810|NCT02876523|"~     The management of hilar biliary strictures remains difficult. These strictures are~     classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should~     be performed in types I and II while a percutaneous drainage is performed in type IV. There~     is controversy as to whether partial or complete liver drainage should be done. Furthermore~     there are no standards for drainage types (metallic stents, plastic stents). Morbidity~     remains high and a multistage procedure can be required.~      This study aims at evaluating the clinical practices in the investigators' center in order~     to determine the key factors that contribute to the drainage success or failure.~   "
13811|NCT02876510|"~     The ACTolog clinical trial IMA101-101 is a first-in-human trial for the ACTolog concept~     targeting patients with advanced stage solid cancers depending on the expression of ACTolog~     targets within their tumors. In the IMA101-101 trial, a patient's tumor is first biomarker~     tested for the expression of ACTolog targets (antigen warehouse). Only if the individual~     tumor is positive for at least one ACTolog target, the patient will be enrolled in the~     trial.~   "
13812|NCT02876497|"~     Surgical samples of human primitive breast: Representative and various surgical samples of~     human primitive breast carcinoma in terms of histological type. Moreover, healthy tissue~     from the same patient will be analysed in parallel. Adjacent normal epithelial structures~     will be defined as at least 5 mm away from the tumor and histologically normal in~     appearance.~      Isolation, differentiation of human monocyte-derived Macrophages (Mphs) and determination of~     the Macrophage (Mph) migration mode : Human Mphs will be differentiated from blood monocytes~     isolated from the same patient than the tumor sample. Blood samples will be obtained~     following standard ethical procedures.~   "
13813|NCT02876484|"~     The purpose of this study is to examine the effects of bile acid and bile acids sequestrants~     on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.~   "
13814|NCT02876471|"~     Emerging evidence suggests that there is a causal link between obstructive sleep apnea(OSA)~     and hypertension. Patient with this syndrome exhibit several characteristics: high~     prevalence, frequent non-dipper status, diastolic and nocturnal predominance, which are~     related to clinical and subclinical organ damage in heart and brain. However, the influence~     of OSA on nocturnal hypertension development has not yet been clarified. Blood pressure~     variability (BPV) plays a role in vascular damage, independent of blood pressure. Apnea~     overloads the autonomic cardiovascular control system and may influence BPV,which is~     classified by different time interval, including beat-to-beat, hour-to-hour day-to-night~     changes or long-term, for example days, weeks, months, seasons, and even years. All BPV~     abnormalities are associated with an increased incidence of cardiovascular events and~     mortality. The investigators pre-experiment estimate BPV by ambulatory blood pressure~     monitoring (ABPM), which unable to capture the BP fluctuation accurately during the apnea~     event. The small studies exam beat-to-beat BP and OSA，and the investigators can't couple the~     events with blood fluctuation, also incapable calculate the correlation of them. This study~     is aimed to use pulse transmit time(PTT) based blood pressure measurement which can be~     useful for continuous monitoring of blood pressure to monitor nocturnal beat-to-beat blood~     pressure fluctuation in OSA with or without hypertension, investigating the degree of~     relevance between hypoxia, AHI, nocturnal hypertension development and BPV. Besides that the~     investigators also evaluate the effect of continuous positive airway pressure(CPAP) on blood~     pressure and nocturnal beat-to-beat BPV.~   "
13815|NCT02876458|"~     Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The~     most common cause of SCD is acute coronary artery occlusion. Several registry based studies~     suggest that coronary angiography (CA) performed at admission followed if necessary by~     coronary angioplasty improves in-hospital and long term survival. Recent guidelines~     recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac~     cause of arrest. However there is a lack of randomized data on this topic.~      Several retrospective studies have shown that if the post-resuscitation electrocardiogram~     (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion~     during the CA is high (70-80%). In contrast, if no ST segment elevation is present the~     probability is low (15-20%).~      Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting~     these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA.~     It may increase the delay of performing other therapeutic modalities such as CT brain or~     thorax scan to determine the cause of SCD. Performing the CA 48 to 72 hours after admission~     would facilitate the management of these difficult patients. However if the cause of the~     arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of~     post-arrest shock and the mortality may increase. Therefore a randomized study comparing~     immediate versus delayed (between 48 to 72 hours) CA in survivors of SCD with no obvious~     non-cardiac cause of arrest is warranted.~   "
13827|NCT02876302|"~     This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast~     Cancer (IBC).~      The Following drugs will be use in combination with Ruxolinitinib.~        -  Paclitaxel (also called Taxol)~        -  Doxorubicin also called Adriamycin~        -  Cyclophosphamide, also called Cytoxan~   "
13816|NCT02876445|"~     Huntington's disease (HD) is a rare inherited neurodegenerative disorder, progressing~     between 15 and 20 years and affecting one person out of 10.000. In France, it concerns some~     6.000 patients symptomatic and 12 000 asymptomatic carriers.~      Few extensive researches have been conducted on the progression of the disease, which is~     defined in the literature in 5 stages in a functional approach.~      Therapeutically, no cure for HD is currently validated but only symptomatic treatments.~     There's various treatment options: medicated, humans (physiotherapy, speech therapist,~     occupational therapist, ..).~      Although these treatment options do not prevent the progression of the disease, their~     combination associated with a stimulating environment may slow the decline of physical,~     intellectual and psychic abilities of patients.~      In social terms, patients with HD require sustained support, especially in cases of family~     isolation.~      The behavioural, gaiting and eating disorder as well as the communications difficulties make~     it difficult support daily for the entourage. The caregivers are sometimes dealing with~     untenable situations. Home care services, which are crucial to alleviating dependency,~     relieve family caregivers but are for the most severe patient.~      Moreover, the justified placement decision in an institution generates a feeling of guilt~     for the family.~      The caregiver is the person who brings non-professional assistance , partly or wholly , to a~     dependent member of his entourage , for the activities of daily living. This regular care~     may be provided permanently or not. It can take many forms, such as , care , nursing ,~     support to education and social life , administrative procedures , psychological support .~      Caregivers have their lives profoundly reshaped. They are often forced to give up some of~     their habits , give up their future plans , change their relationships. The commitment of~     caregivers with patients with Huntington's disease actually sounds on their mental and~     physical health, as well as their social and professional life~      Very few studies have been conducted to measure the difficulties and implications of these~     caregivers.~   "
13817|NCT02876432|"~     Activation of the sympathetic nervous system attenuates inflammation via catecholamines,~     recent advances in electroacupuncture allow activating critical neuronal networks with the~     release of catecholamines the aim of this research was to evaluate de effect of~     electroacupuncture in the activation of sympathetic nervous system and the control of low~     back pain in athletes~   "
13818|NCT02876419|"~     The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B /~     hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In~     this protocol, similar reduction/clearance of serum HBsAg and improved response to~     immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol~     was designed to include a 24 week follow-up period after treatment, however given the strong~     antiviral response against HBV and HDV infection in these patients, it is now important to~     extend the follow-up period in these patients to monitor over a longer period after~     treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in~     the REP 301 protocol.~   "
13819|NCT02876406|"~     This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications~     after elective cardiac surgery, comparing it with others markers such as lactate,~     arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for~     postoperative complications.~   "
13820|NCT02876393|"~     Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with~     diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related~     to the high and fluctuating sugar levels in the blood stream. An eye with DR will have~     abnormal appearing retinal blood vessels which become engorged and dilated, leaky and~     fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia~     (lack of blood supply). A particular feature of DR is the accumulation of fluid in the~     macula which is the central part of the retina and responsible for detailed eye sight. This~     peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation~     without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance~     and abnormalities of blood fats are found. The investigators wish to study DR and DMO using~     high resolution retinal imaging and functional tests in normal participants, those~     participants with diabetes without any overt signs of disease and those with DR and DMO in~     order to understand how the condition develops and whether there are any unique risk factors~     that can be identified~   "
13821|NCT02876380|"~     The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval~     on 12 lead electrocardiogram (ECG), strengthened by a positive family history and/or~     characteristic arrhythmias and confirmed by genetic testing. However, for several reasons~     such LQTS testing cannot be performed successfully before birth. First, fetal ECG is not~     possible and direct measure of the fetal QT interval by magnetocardiography is limited to~     fewer than 10 sites world-wide. Second, while genetic testing can be performed in utero,~     there is risk to the pregnancy and the fetus. Third, although some fetuses present with~     arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular~     (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common~     presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is~     unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and~     undiagnosed during fetal life, with dire consequences. For example, maternal medications~     commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal~     fetal ventricular arrhythmias. But the most significant consequence is the missed~     opportunity for primary prevention of life threatening ventricular arrhythmias after birth~     because the infant is not suspected to have LQTS before birth. The over-arching goal of the~     study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to~     do so by developing an algorithm using fetal heart rate (FHR) which will discriminate~     fetuses with or without LQTS.~      Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study~     to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses~     recruited from 13 national and international centers where one parent is known by prior~     genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated~     channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2~     (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have~     chosen this population because 1) These mutations are the most common genetic causes of~     LQTS, and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene~     mutations is autosomal dominant. Thus, progeny of parents with a known mutation are at high~     (50%) risk of having the same parental LQTS mutation. The algorithm will be developed using~     FHR measured serially throughout pregnancy. All offspring will undergo postnatal genetic~     testing for the parental mutation as the gold standard for diagnosing the presence or~     absence of LQTS.~   "
13822|NCT02876367|"~     This study to collect and identify rodents and mites across transects through diverse~     habitats used by the human community from a localised area identified as a scrub typhus 'hot~     spot'.~   "
13823|NCT02876354|"~     Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is~     reflected by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein~     (dp-ucMGP) and seems to be correlated with vascular calcifications. Vascular calcifications~     can be assessed using the AC24 score on a lateral abdominal X-ray.~      The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis~     cohort after supplementation with vitamin K2 and the correlation between this rate of~     decrease and the Aortic Calcification Severity (AC24) score. The factors associated with~     high levels of dp-ucMGP will be analyzed as well.~   "
13824|NCT02876341|"~     Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy~     on new onset atrial fibrillation and clinical outcomes in septic shock.~   "
15931|NCT02848885|"~     This is a novel study that seeks to explore the clinical and functional imaging effects of~     transcranial direct current stimulation (tDCS) on illness awareness or anosognosia in~     schizophrenia, arguably the most treatment-resistant manifestation of the disorder.~   "
13828|NCT02876289|"~     Perampanel is a non-competitive antagonist of the AMPA (~     2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved~     by the European Medicines Agency as adjunctive treatment for partial-onset seizures in~     patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and~     safety of perampanel as add-on treatment in patients with refractory epilepsy.~      The investigators retrospectively collected and analyzed the data of patients with~     refractory epilepsy who had been treated with perampanel between May of 2014 and April of~     2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The~     mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d~     (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the~     responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were~     reported in 60 patients (54.5%). Most common side effects were behaviour disturbance~     (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).~   "
13829|NCT02876276|"~     Hyaluronic acid (HA) has been used as a dermal filler in medicine for many years. It also~     has umpteen benefits in terms of aiding in rapid healing and resolution of inflammation.~     Thus in the present study, HA has been used at the test site to fill papillary recession~     defects. At the control site saline was injected as the placebo.~   "
13830|NCT02876263|"~     The aim of this prospective, explorative study of noninvasive neuromonitoring was to search~     potential and practical methods associated with neurological outcome in the perioperative~     and immediate postoperative setting of surgery of the thoracic aorta. These methods include~     abbreviated EEG monitoring, near-infrared spectroscopy, transcranial Doppler ultrasound and~     biochemical markers associated with neuronal damage.~   "
13831|NCT02876250|"~     The morbidity and mortality of patients undergoing lung transplantation in the acute phase~     following surgical intervention is mainly due to the primary graft failure (PGF).~      The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion~     injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from~     the donor (cold ischemia) followed by another when it is grafted into the recipient's~     thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to~     reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is~     associated with significantly higher levels of 30-days all-cause mortality. Patients with~     PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.~      Ischemic postconditioning, has recently been described in experimental models of~     ischemia-reperfusion injury in the heart, and although not yet fully understood. Several~     studies suggest that the mitochondria play a central role in cellular survival mechanisms~     after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability~     transition pore (mPTP)).~      Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion~     binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective~     effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in~     clinical phase II trials in reperfused myocardial infarction patients.~      The hypothesis of this study is that the administration of CsA in transplanted patients~     (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s)~     from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency~     and severity of PGF.~   "
13832|NCT02876237|"~     The investigators propose to carry out a prospective analysis of physical impact,~     psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of~     localized prostate cancer with an indication of curative radiotherapy. This standardized~     geriatric assessment will collect social information, functional, sensory, cognitive,~     emotional, motor, nutritional, and medical related to comorbidities . The quality of life of~     patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European~     Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the~     end of radiotherapy (2 months) and at 6 months. This short follow-up period seems~     appropriate in this elderly population and will allow an answer within 2 years to the~     problem raised in clinical practice.~   "
13833|NCT02876224|"~     This is an open-label, multicenter, single-arm, two-stage, Phase Ib study designed to assess~     the safety, tolerability, and pharmacokinetics of oral cobimetinib with intravenous (IV)~     atezolizumab and bevacizumab in participants with metastatic colorectal cancer (mCRC) who~     have received and progressed on at least one prior line of therapy that contained a~     fluoropyrimidine and oxaliplatin or irinotecan. There are two stages in this study: Stage 1~     (safety run-in period) and Stage 2 (dose expansion with two cohorts, an expansion cohort and~     a biopsy cohort).~   "
13834|NCT02876211|"~     Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol~     is a selective vitamin D receptor activator with potential benefits on anti-inflammatory~     cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may~     improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.~   "
13835|NCT02876198|"~     The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is~     currently the standard treatment for retinal neovascularization. The VEGF stimulates~     endothelial cells' proliferation and migration. It also increases microvascular~     permeability. If the VEGFs have proven their efficiency in the decrease of choroidal~     neovascular proliferation, their impact of the head of the optic nerve's microvasculature is~     yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with~     oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by~     the anti-VEGF may have an incidence on the loss of retinal nerve fibers.~   "
13836|NCT02876185|"~     Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension.~     The treatment aims to stabilize the visual field deficiencies by lowering the intraocular~     pressure. Due to the fluctuation of the visual field test and re-test measures, the European~     recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in~     order to know if the pathology is progressing despite the current treatment (or if the~     treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists~     renders the monitoring of a beginning glaucoma, rarely compatible with the present~     recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when~     faced to a decreasing medical demography and an increase the patient's needs.~      This study should allow to validate the possibility to delegate monitoring tasks to~     orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to~     orthoptists would permit a better distribution of the ophthalmologist's activities.~   "
13837|NCT02876172|"~     This small study will look at the safety and estimate the strength of effect (effect size)~     of a combination of Cognitive Behavioral Conjoint Therapy (CBCT) and~     3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in ten pairs of people, one~     with and one without PTSD. The pairs can be spouses or romantic partners, siblings or other~     relatives or close friends. The study will measure PTSD symptoms, as well as symptoms of~     depression, sleep quality and relationship satisfaction and functioning before and after a~     one-month course of CBCT that includes two MDMA+CBCT visits. CBCT psychotherapy is designed~     to treat PTSD and relationship problems in pairs in a close relationship, and MDMA-assisted~     psychotherapy uses the experimental drug MDMA to enhance and strengthen psychotherapy. There~     is evidence that each of these treatments, on its own, can help people with PTSD. The study~     will also measure personality and how each member of a pair thinks about and behaves in~     relationships and expresses emotions before and after having MDMA+CBCT. Pairs will have two~     day-long sessions scheduled two weeks apart. During the first MDMA+CBCT session, both~     members of the pair will receive 75 mg MDMA with the option of receiving a second dose of~     37.5 approximately an hour and a half later. During the second session of MDMA+CBCT,~     subjects may receive either 100 or 75 mg, with the decision concerning dose made by the~     researchers after discussion with the subjects. An optional dose half the size of the~     initial dose will be offered approximately an hour and a half later. Following informed~     consent and screening there will be one enrollment visit over videoconference. Before the~     first MDMA+CBCT session, there will be an introductory session including 3 segments of CBCT~     psychotherapy on the day before the first MDMA session. The introductory session and the~     CBCT sessions will be done in person at the study site. During each MDMA+CBCT sessions, two~     therapists will work with with the pair. Blood pressure, heart rate and body temperature~     will be measured periodically during each MDMA+CBCT session. The pair will stay at the study~     site overnight with a night attendant on duty, and they will have an integrative~     psychotherapy session on the morning after the MDMA+CBCT session. Each member of the pair~     will be contacted by the researchers for a week after each MDMA+CBCT session. The pair will~     have CBCT and integrative sessions over videoconferencing twice a week for two weeks~     following the on-site integrative session. One month after the second MDMA+CBCT session,~     both participants will have an evaluation and testing visit over videoconference and will~     complete measures of PTSD symptoms, sleep quality, perceived growth related to experiencing~     a trauma, symptoms of depression, and how people think and feel about emotions and their~     relationships. The member of the pair with PTSD will also undergo an interview measure of~     PTSD symptoms. The pair will complete measures and questionnaires three and six months after~     the second MDMA+CBCT session. The study is open label, meaning the researchers and subjects~     will be aware of the doses of MDMA used in the study. The study will test and compare~     changes in symptoms and relationship issues before and after the course of psychotherapy.~   "
13838|NCT02876159|"~     This is a prospective pilot study designed to suggest differences in the immunologic~     response to the seasonal influenza vaccine in people with regular vaccination history~     compared to those vaccinated less regularly. Participants will receive one dose of the Food~     and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system~     data will be collected at standard time points. The duration of the study for each~     participant will be approximately 1 month.~   "
13839|NCT02876146|"~     Study design to define improved management of patients with hepatic alveolar echinococcosis~     treated with albendazole and especially make appropriate and timely decision of treatment~     withdrawal .~      Based on exploratory analysis of existing and newly developed biological and imaging exams,~     for diagnosis and follow-up, and study of the relationship of these markers to the viability~     of the parasite and/or the activity of the parasitic lesions The study included two series~     of patients: operated on (curative hepatectomy) // non-operated on~   "
13840|NCT02876133|"~     Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in~     most European countries. Colonoscopy has been shown to reduce CRC incidence, however its~     effectiveness depends on the sensitivity to detect pre-malignant lesions.~      Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as~     novel tools for the early detection of colonic sessile serrated lesions (SSL). The~     investigators will perform a multicenter-randomized-controlled-trial to study the role of~     NBI in SSL detection.~   "
13841|NCT02876120|"~     The START study will implement osteoarthritis (OA) treatment recommendations to increase the~     use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary~     referrals to secondary care, unnecessary use of costly imaging modalities and use of~     treatment modalities supported by low quality of evidence). The purpose of the STavanger~     osteoARThritis (START) study is to improve the quality of OA care and increase the~     collaboration between health care professionals in primary health care and across health~     care levels.~   "
13842|NCT02876107|"~     The goal of this clinical research study is to learn if adding panitumumab to the~     combination of carboplatin and paclitaxel can help to control IBC when given before other~     standard chemotherapy and surgery. The safety of these drug combinations will also be~     studied.~   "
13843|NCT02876094|"~     Several factors make the use of celecoxib in human SMA patients appealing including: 1)~     low-dosing required for potential therapeutic effect (the corresponding dose in humans is~     much lower than that commonly used in adults and children with; 2) favourable side effect~     profile of this drug (particularly at the dosing required); 3) the fact that celecoxib~     crosses the blood brain barrier and 4) demonstration of efficacy in a genetically and~     pathophysiologically faithful animal mode. The investigators therefore believe that~     celecoxib is a promising disease modifying therapy for SMA.~   "
13844|NCT02876081|"~     Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of~     lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic~     disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a~     mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase~     inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of~     chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy,~     frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and~     improves survival from approximately 4.5 with best supportive care alone to 15 months.~     However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6~     months and benefit from a second-line chemotherapy. Authorized drugs in this setting are~     pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients~     whose tumor does not harbor an EGFR mutation is questionable . In the second line setting,~     docetaxel provides less than 10% of partial responses and progression-free survival of 10 to~     12 weeks. There are no standard options following failure of two previous lines of standard~     chemotherapy. In view of these modest results, new agents and therapeutic strategies are~     greatly needed for this patient population.~      Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the~     central nervous system and in periphery. At the peripheral level, NTS is released by the~     endocrine cells of the intestinal mucosa after meals and acts as an endocrine hormone~     involved in the postprandial regulation of the motor functions of the gastrointestinal~     tract. The effects of NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2~     exhibit high and low affinity for NTS, respectively, and belong to the family of G protein~     receptors; NTSR3 is a single transmembrane domain receptor. Exogenous activation of NTSR1~     leads to cell proliferation, survival, mobility and invasion in cancer cells from diverse~     origin. These effects are the result from the activation of kinases and effectors, such as~     PKC, MAPK, FAK, RHO-GTPase, RAS and Src. The PKC activation may induce MAPK by direct~     stimulation of Raf-1, or by transactivation of the EGFR. The activation of MAPK via NTSR1 is~     mainly associated with uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of~     lung tumors, whereas they are never expressed in the normal tissue. NTSR1 high expression is~     a negative prognostic factor in stage I to III operated lung adenocarcinomas. Sustained~     stimulation of NTSR1 results in the activation of MMP1, the release of EGF like ligands~     such as HB-EGF as well as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR,~     HER2 and HER3 overexpression and activation. Accordingly, xenografted tumors expressing NTS~     and NTSR1 show a positive response to erlotinib, whereas tumors void of NTSR1 expression~     have no detectable response.~      Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In~     preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in~     tumour growth inhibition and regression of established subcutaneous tumours derived from~     four human cell-lines known to co-express ErbB receptors.~      Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will~     respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin~     activation.~      Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all~     lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR~     TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high~     level of expression. This subpopulation of patients represents approximately 20% of lung~     adenocarcinomas.~   "
13845|NCT02876055|"~     Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting~     in severe postoperative pain, especially in the first 48 hours after surgery. The use of~     interscalene brachial plexus nerve block remains the cornerstone for analgesia following~     shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has~     been increasing interest in its use for total joint arthroplasty.~      Since the benefits of local infiltration analgesia within a comprehensive multi-modal~     analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the~     Investigators plan to assess and compare analgesia outcomes between three intervention~     groups: single shot interscalene brachial plexus block (SISB), continuous interscalene~     brachial plexus block (CISB), and local infiltration analgesia (LIA).~   "
13846|NCT02876042|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO system in the commercial setting in subjects recently implanted under the CE-Marked~     indication for resistant hypertension that also have evidence of heart failure with~     preserved ejection fraction (HFpEF).~   "
13847|NCT02876029|"~     The study focus is on the possible improvement in glucose tolerance at a second standardized~     meal that can be achieved when preceded by a test meal with a low GI and a high GP.~   "
13854|NCT02875938|"~     This investigation uses a single-subject, adapted alternating research design to compare two~     different experimental conditions using music with lyrics combined with visual stimulation~     of the written lyrics, to extend the emotional word effect to phrases, in order to stimulate~     reading comprehension of the trained material for patients with aphasia. The two music~     conditions include 1) music with sung lyrics simultaneously with silent reading of the~     written lyrics; and 2) music with sung lyrics, followed by silent reading of the written~     lyrics (i.e. priming with the music). A control set without music will be used additionally~     within every third session to detect potential history and maturation effects. All~     conditions will be followed by a silent reading phrase-completion task composed of written~     words from the total combined sets of stimuli.~   "
13848|NCT02876016|"~     Bring elements of understanding to the study of brain organization bodily representations.~     The body is organized into multiple, distinct levels of representation. The body schema is~     an unconscious and dynamic representation of his body, updated constantly, resulting from~     the convergence of multiple sensory information, which articulates with the motor systems to~     participate in the genesis of the action. The self-image corresponds to a more abstract~     representation of the body, covering symbolic and imaginary aspects drawn from the emotional~     life of the individual. Finally, the body of another person engages simultaneously shared~     and differential representational systems that allow understanding the actions of others~     while preserving the identity of the agent responsible for the action. These various bodies~     represented subtly interacting and participating in equilibrium, the self-awareness building~     as being curious, social and acting. Brain organization bodily representations remains a~     fundamental question still poorly explored that is of major scientific interest because of~     its influence on identity and social construction, and the serious repercussions that are~     their problems, also for the individual and society. This project aims to deepen this~     hypothesis using a methodology combining functional imaging and awake surgery. The richness~     of this project lies in the innovative methods of investigation, and in the plurality of~     disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams~     (clinical and research) grouped for wear.~      The subjects enrolled in this study are all candidates in patients with awakened provided~     surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake~     neurosurgery is for patients with glial tumors, but also brain metastases and~     intra-parenchymal cavernomas. A first experimental session will be held in pre-operative~     period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a~     precise functional mapping of cortical structures, including lateral occipital, involved in~     body representation. The second experimental session will be conducted in the neurosurgical~     intervention, practiced one to four weeks later.~      This dual approach that combines the functional stimulation of a cortical area (imaging) and~     functional inhibition (in surgery) allows you to make extremely robust scientific arguments~     about the causal relationships linking structure and function~   "
13849|NCT02876003|"~     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over~     50% of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical~     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to~     improve second-line therapy in GBM have met with only marginal success and there is a large~     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug~     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,~     but not by normal cells or blood vessels in normal tissue. It is believed that activation of~     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the~     activity, safety and CNS exposure of G-202 in patients with PSMA-positive recurrent or~     progressive GMB receiving G-202 by intravenous infusion on three consecutive days of a~     28-day cycle.~   "
13850|NCT02875990|"~     Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of~     cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are~     associated with immunosuppression and lack of T cell response Such mechanisms would promote~     progression to cancer and progression of it . Various factors such as an increase of~     regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling~     pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms.~     At this stage of knowledge, a better characterization of local and systemic~     immunosuppressive signing of cervical cancer is needed. The results should have a~     significant medical impact for the identification of new prognostic markers and new~     therapeutic targets for the treatment of patients with cervical cancer.~      The aim of this research project is to define the signing of immunosuppressive cancer cervix~     and analyze the different mechanisms involved in this immunosuppression.~   "
13851|NCT02875977|"~     The investigators intend to measure compliance with attending pelvic floor physical therapy~     (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute~     educational video or reading a handout explaining the therapy.~   "
13852|NCT02875964|"~     Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions~     implied in epileptic discharges and in normal function.~      The current practice in most cases is to implant intracerebral electrodes in order to~     localize these regions in a reliable manner. However, non-invasive methods have been~     developed in order to record brain activity with no risk for the patient.~      Still, it is necessary to validate and improve the signal processing methods and the~     underlying models these methods in order to optimize their use in clinical practice. To do~     so, it is necessary to record simultaneously electroencephalogram (EEG) and~     magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous~     recordings will permit to confront the exact same activity recorded non-invasively at the~     surface of the head, and represented on the brain thanks to the model and directly within~     the brain.~      The objective is to define the conditions under which one can represent faithfully the~     activity measured intracerebrally from the surface measurements.~      It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60~     patients. It will be record resting state signals, as well as stimulation protocols. The~     interictal epileptic discharges will be marked on the different modalities, and evoked~     potentials/fields computed in response to protocols. Sensitivity of recordings to activity~     visible on depth recordings will be evaluated as a function of localization of brain~     generators. Advanced signal processing methods will be used such as source localization and~     independent component analysis, in order to increase sensitivity of measures.~   "
13853|NCT02875951|"~     A prospective, non-interventional, non-controlled multicenter observational study to~     evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with~     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with~     everolimus and exemestane.~      The main objective of the study is to evaluate medication adherence in postmenopausal,~     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a~     combination of everolimus and exemestane. Additionally, other aspects of the~     pharmacotherapy, with focus on the patient perspective, will be investigated:~        -  Patient satisfaction with treatment information~        -  Patient satisfaction with treatment~        -  Health-related quality of life~        -  Treatment efficacy~        -  Treatment-related toxicity~        -  Patient follow-up by the oncologic team/general practitioner and or specialized home~          nurses~      This study should reveal information necessary for the development of pharmacotherapeutic~     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug~     over a long period.~   "
13855|NCT02875925|"~     This is a non-randomized, prospective, quasi-experimental study designed to assess the~     impact of pharmacist-provided medication management on total cost of care and clinical~     outcomes (ie, hospitalizations, emergency department visits) in a real-world clinical~     practice.~   "
21507|NCT02775669|"~     Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which~     underwent an operation due to craniosynostosis.~   "
13856|NCT02875912|"~     This study will evaluate whether or not engaging family members of patients admitted to the~     ICU in Family Care Rituals will reduce stress related symptoms of PTSD, depression and~     anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are~     defined as several domains in which family participation may be of benefit, focusing on the~     5 physical senses as well as the personal care of the patient and spirituality of the~     patient~   "
13857|NCT02875899|"~     Prospective, single-arm, multicentre, international Registry of the Surfacer System for the~     treatment of patients with limited or diminishing upper body venous access or pathology~     impeding standard access methods.The purpose of this post-market Registry is to assess the~     standard of care and clinical outcomes of the Surfacer System used in clinical routine~     according to the approved commercial indications.~   "
13858|NCT02875886|"~     In this clinical study the anti-hypertensive response to dietary salt restriction is~     compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride~     in adult patients with chronic kidney disease.~   "
13859|NCT02875873|"~     A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution~     compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically~     ill patients~   "
13860|NCT02875860|"~     This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO)~     rather than expectant management during pregnancy, followed by standardized postnatal~     management, increases survival at discharge and decreases oxygen need at 6 months in case of~     survival till discharge.~   "
13861|NCT02875847|"~     The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients.~     A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria~     will be included. The participants will be randomized into one of three groups consuming~     either HMO (two groups) or placebo (one group).~      The primary objective of the study is to establish the effect of HMOs on the faecal~     microbiota in IBS patients. Secondary objectives are to assess the effect on~     gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and~     anxiety and depression.~   "
13862|NCT02875834|"~     To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once~     daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having~     achieved normokalemia following two days of initial ZS therapy (10g TID).~   "
13863|NCT02875821|"~     In this study, the investigators investigate beneficial effects of ipragliflozin, newly~     developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in~     subjects with T2DM when added to metformin and pioglitazone therapy.~   "
13864|NCT02875808|"~     The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal~     infection in neurosurgical patients with an external ventricular drainage is evaluated.~   "
13865|NCT02875795|"~     The hypothesis of the present study is that an automatic assessment technic can measure the~     impact of the speech disorders on the communication abilities giving a severity index of~     speech in patients treated for head and neck and particularly for oral and pharyngeal~     cancer.~   "
13866|NCT02875782|"~     The study is a randomized controlled trial (RCT) on a tailored smoking cessation~     intervention targeted type 2 diabetic patients who smoke (DM intervention). The objectives~     are:~        1. to study the effectiveness of the DM intervention in achieving (a) smoking cessation,~          (b) smoking reduction, and (c) progress to a higher stage of readiness to quit;~        2. the changes in levels of HbA1c between (a) the intervention group and the controls, and~          (b) quitters and continuing smokers;~        3. the predictive factors for the success of the outcomes above.~   "
13867|NCT02875769|"~     The aim of this randomized, single blinded clinical trial was to evaluate the effect of a~     pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and~     sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a~     dental prophylaxis with ultrasonic scaler.~   "
13868|NCT02875756|"~     The investigators plan to evaluate the effect of the number of needle revolutions inside the~     node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA) in patients with sarcoidosis.~   "
13869|NCT02875743|"~     Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients~     undergoing intensive chemotherapy or transplantation.~      This current study aims to assess the impact of prophylactically using the broad-spectrum~     anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic~     anaemia and those undergoing intensive chemotherapy, for example for acute myeloid~     leukaemia, and allogeneic stem cell transplantation.~   "
13870|NCT02875730|"~     This is a prospective trial investigating the effectiveness of a modified MRI preparatory~     pulse sequence to improve pulmonary vein isolation visualization.~   "
13871|NCT02875717|"~     Retrospective Analysis of patients that received shockwave lithotripsy as Treatment of~     ureteral or kidney Stones. Condition examinated is the effect of low molecular weight~     Heparins and acetylsalicylic acid on the Formation of renal hematoma after shockwave~     lithotripsy. Primary outcome is documented hematoma in a postoperative ultrasound control.~     Secondary outcomes are perioperative complication, Need for erythrocyte tranfusion,~     interventions for bleeding control, readmission or death within 30 days.~   "
13872|NCT02875704|"~     In this study, markers of oxidative stress will be measured in the aqueous humour of~     stargardt disease, age related macular degeneration and diabetic retinopathy patients~     compared to controls.~   "
13873|NCT02875691|"~     This randomized double blind clinical trial performed on 68 patients (32 in intervention and~     36 in control group) diagnosed with SLE. The patients in intervention group were given daily~     dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of~     two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg~     of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some~     biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline~     and end of the study.~      The investigators used SLEDAI (systemic lupus erythematous disease activity index )~     questionnaire for evaluating the clinical signs of the disease. The questionnaires filled~     out at baseline and after 3 month.~   "
13874|NCT02875678|"~     A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and~     Nutrient Volume Tolerance in Patients with Functional Dyspepsia.~   "
13875|NCT02875665|"~     This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the~     treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in~     older people living at home or in a Care Home. It will determine patient acceptability,~     tolerability and usability of the T-2 gekoTM device for FI by assessing:~        1. device user factors: acceptability of use, ease of device placement, ease of device~          interface control and understanding of device instructions;~        2. tolerability of device: skin tolerability.~   "
13876|NCT02875652|"~     Quantification and follow-up during 3 years of circulating tumoral DNA in patients with~     choroidal melanoma~   "
13877|NCT02875639|"~     The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue~     prescription which treat the disease of qi deficiency and blood stasis. And at the same time~     this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of~     coronary heart disease (CHD) heart failure the curative effect and security.~   "
13878|NCT02875626|"~     This is a single-center prospective study evaluating the diagnostic performance and safety~     of Infracyanine in women with early breast cancer whose the research of sentinel node(s)~     combines isotopes and Infracyanine.~   "
13879|NCT02875613|"~     The purpose of this study is to determine whether avelumab, an investigational antibody~     against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer.~     Avelumab is designed to block the interaction between programmed cell death protein 1~     (PD-1), a known immune checkpoint, and PD-L1. By blocking this interaction, the immune~     system may be stimulated, allowing it to more effectively recognize and attack the cancer.~   "
13880|NCT02875600|"~     To determine the difference in baseline MR flow measurements and post-prandial MR flow~     measurements between patients diagnosed with CGI and patients not diagnosed with CGI.~   "
13881|NCT02875587|"~     The aim of this study is to compare the efficacy of calcium gluconate infusion versus~     cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients~     pretreated with GnRH agonist long protocol who are at high risk for OHSS.~   "
13882|NCT02875574|"~     The 'rising tide' of antimicrobial resistance is a source of concern across most infectious~     diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were~     resistant to the cheap and effective first-line drug isoniazid. It is of great importance to~     prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance~     by treating such patients as well as possible.~      Currently, guidance on the best treatments for isoniazid resistant tuberculosis is~     inconsistent globally. Data from randomised controlled trials, the peak quality of evidence,~     is sparse. It is thus important that studies using pre-existing observational data are~     undertaken.~      The investigators aim to use data and samples collected from Public Health England and~     National Health Service hospitals to determine a) the best treatments for patients with~     isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug~     resistance in the infecting bacteria influence a) (nested case-control study). Eligible~     participants will have had isoniazid resistant tuberculosis (without associated rifampicin~     resistance) in England between 2009 and 2013 and will have been notified to Public Health~     England. The study will be conducted at University College London, National Health Service~     hospitals and Public Health England and will last until December 2017. Patient hospital~     records and disease surveillance records will be accessed and cultured bacteria from~     previously stored samples sequenced.~   "
13883|NCT02875561|"~     The primary objective of this study is to evaluate the incidence of vulva dysplasia~     recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or~     ultrasonic aspiration.~   "
13884|NCT02875548|"~     This study will provide continuing availability to tazemetostat as a single agent to~     subjects who have completed their participation in an antecedent tazemetostat study (either~     with monotherapy or combination therapy). In addition, long-term safety and overall survival~     will be collected.~   "
13885|NCT02875535|"~     Reducing youth suicide in the U.S. is a national public health priority. Sexual and gender~     minority adolescents are at elevated risk for suicide. Safer school environments, however,~     can decrease this risk. This study capitalizes on the critical role of school nurses in~     improving the mental health of this vulnerable population through implementation and~     sustainment of evidence-based strategies to enhance school environments. In addition to~     suicide, the conceptual framework and methods for this novel, nurse-led intervention can be~     applied to address the health-related concerns of other pediatric populations encountered in~     school settings as well.~   "
13886|NCT02875522|"~     The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to~     inflammation in the lungs and blood vessels that can lead to secondary problems such as~     blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has~     been shown to reduce the risk of heart and brain disease; however, it is currently unknown~     whether exercise training can have the same affect in patients with COPD. The aim of this~     study is to investigate how eight weeks of aerobic exercise training improves blood vessel~     and heart function and brain blood flow in patients with COPD.~   "
13887|NCT02875509|"~     One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years~     1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory~     cells during the first 24 hours after surgery. The results of the differential count were~     computerized by using artificial neural network for obtaining wound inflammatory cell node~     (WICN). The patients were followed up for sixteen years or to the death. WICN values were~     compared with the patients´ survival.~   "
13888|NCT02875496|"~     Establishment of a BNA reference database for the Adult and Elderly Population.~     Hypothesis-generating study designed to collect data that will aid in future scientific and~     engineering exploration of correlations between clinical assessments and BNA scores. The~     results are primarily intended for scientific inquiry and engineering development purposes,~     and may be used in future regulatory submissions.~   "
13912|NCT02875184|"~     This is a multicenter, prospective, non-interventional, observational single arm study.~      Two-hundred patients will be recruited in the Netherlands over a one year period. In all~     cases, the decision to treat the patient with apremilast will be made prior to the decision~     to enter the subject into this study. Treatment will be according to routine clinical~     practice and based on recommendations as per the Summary of Product Characteristics (SPC) of~     apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.~   "
13889|NCT02875483|"~     Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is~     detrimental to maternal and child health. Tubal sterilization may be performed immediately~     following a delivery, or as an interval procedure remote from pregnancy. Many women request~     sterilization to follow delivery, but it is frequently not completed during the peri-partum~     hospitalization. Women who are denied an immediate post-partum tubal are generally~     candidates to complete the procedure as an interval surgery within a few months of delivery,~     but few do so. Women who request tubal sterilization and do not receive it are at highest~     risk for a rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within~     1 year.~      The standard care at many institutions for a patient denied tubal sterilization during~     hospitalization is to offer a short term contraceptive and instruct the patient to follow up~     for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires~     tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates~     for post-partum care are high at about 50%-60%, and therefore, many patients are never~     scheduled for their surgery. If the process of scheduling interval tubal sterilization~     surgery could be expedited, rates of completion could be improved.~   "
13890|NCT02875470|"~     This study compares the efficacy of diamond burs and Gracey curettes in non-surgical~     periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical~     parameters and scanning electron microscopic investigations on root surfaces. Two quadrants~     of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were~     treated with Gracey curettes. Also 21 hopeless teeth received root planing either with~     diamond burs or curettes or no treatment at all and were then extracted for microscopic~     evaluations.~   "
13891|NCT02875457|"~     Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several~     phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer~     and other tumors also showed apatinib has less toxic side effects and better patient~     tolerance. However, the clinical application of apatinib in small cell lung cancer is still~     lack of evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line~     treatment for small-cell lung cancer. The purpose of this multicenter, randomized,~     prospective study is to investigate the efficacy and safety of apatinib as the maintenance~     therapy for extensive stage small cell lung cancer after combined with etoposide and~     cisplatin chemotherapy.~   "
13892|NCT02875444|"~     Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk~     of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's~     treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of~     45-50 mm in women.~      The importance of this measure for patient management justify a specific and homogeneous~     protocol of measure. However, the diversity of methods of measuring the maximum diameter~     with scanner and ultrasound was shown.~      The impact of various angio-CT based measures of maximum AAA diameter, and the impact of~     reproducibility limits on the decision to operate have never been investigated.~   "
13893|NCT02875431|"~     Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy~     and fusion~   "
13894|NCT02875418|"~     Background:~      Identification and measurement of uterine contractions throughout pregnancy and labor is~     crucial to the well being of both mother and fetus. Prematurity is one of the major causes~     for adverse pregnancy outcomes, and clinical decision-making often relies on uterine~     frequency as recorded by a tocodynamometer, as well as on other methods including~     sonographic cervical length, pelvic examination.~      Objective:~      To show that the use of the EUM in preterm labor is effective in establishing true preterm~     labor.~   "
13895|NCT02875405|"~     The purpose of this study is to determine if preforming a posterior left pericardiotomy~     prevents atrial fibrillation after cardiac surgery.~   "
13896|NCT02875392|"~     Studies reveal special function of fucoidan so far include anti-virus, anti-tumor,~     immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney~     dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on~     the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.~   "
13897|NCT02875379|"~     Background. Non invasive positive pressure ventilation (NIV) is among first line treatments~     of acute respiratory failure. Several interfaces are available for non-invasive~     ventilation.Despite full face and oronasal masks are more frequently used, some evidence~     suggests that helmets may optimize patients' comfort and NIV tolerability.~      During NIV, humidification strategies (heat and moisture exchangers HME or heated~     humidifiers HH) may significantly affect patient's comfort and work of breathing.~      Despite physiological data suggested heated humidification as the best strategy during NIV~     with full face masks, no differences were found in a randomized controlled study assessing~     the effects of HME or HH on a pragmatic clinical outcome.~      However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet~     NIV make such results not applicable to this particular setting.~      The investigators designed a randomized-crossover trial to assess the effect of four~     humidification strategies during helmet NIV on patients with acute respiratory failure, in~     terms of comfort, work of breathing and patient-ventilator interaction.~      Methods. All awake, collaborative, hypoxemic patients requiring mechanical ventilation will~     be considered for the enrollment. Hypercapnic patients (i.e.PaCO2>45 mmHg) will be excluded.~      Each enrolled patient will undergo helmet NIV with all the following humidification~     strategies in a random order. Each period will last 60 minutes.~        -  Passive humidification, double tube circuit.~        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification~          chamber temperature 33°C.~        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification~          chamber temperature 37°C.~        -  Passive humidification with HME, Y-piece circuit.~      Ventilatory settings (Draeger Evita xl or Evita infinity ventilators):~      Pressure support ventilation; pressure support=20 cmH20; FiO2 titrated to obtain SpO2~     between 92 and 98%; positive end-expiratory pressure=10 cmH2O; maximum inspiratory time 0.9~     seconds; inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum~     inspiratory flow; pressurization time=0,00 s.~      Such settings will be kept unchanged during the whole study period. An oesophageal catheter~     will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga)~     (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an~     airway occlusion test during NIV with oronasal mask. Work of breathing will be estimated~     with the pressure-time product (PTP) of the pleural pressure.~      A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated~     laptop.~      At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual~     analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the~     Borg dyspnea scale.~      The following parameters will be record at the end of each cycle:~      Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and~     esophageal pressure signals will be reviewed offline to detect patient-ventilator~     asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and~     asynchrony index (number of asynchrony events divided by the total respiratory rate computed~     as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will~     be computed. The trigger delay will be also measured. The pressurization and~     depressurization velocity will be assessed with the PTP airway index 300 and 500~     (inspiratory and expiratory), as suggested by Ferrone and coworkers. The work of breathing~     (WOB) for each breath will be estimated by PTPes.~      An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet~     temperature, relative and absolute humidity.~      Primary endpoints: patient's comfort, work of breathing and asynchrony index.~      Sample Sizing:~      Given the physiological design of the study, the investigators did not make an a priori~     sample size and plan to enroll 24 patients.~   "
13898|NCT02875366|"~     This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in~     subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.~     This study is designed to evaluate the effect of LUM/IVA on manifestations of CF affected by~     exercise tolerance & training.~   "
13899|NCT02875353|"~     The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates~     of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in~     PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for~     prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet~     drugs or with large ulcers) after snare resection of benign colon polyps.~   "
13900|NCT02875340|"~     The objectives of this study are to assess the safety, tolerability, pharmacokinetics and~     efficacy of VAL401 in the treatment of patients with locally advanced or metastatic~     non-small cell lung adenocarcinoma.~   "
13911|NCT02875197|"~     The purpose of this research is to provide clinically, administratively, and field-relevant~     objective running outcomes by directly comparing running biomechanics of individuals with~     lower extremity amputation (ILEA) using RSPs (Running Specific Prostheses) and traditional~     prostheses. Within this purpose, the project has two specific aims:~      Specific Aim 1: To compare RSPs and traditional prostheses with respect to running ability~     and performance~      Specific Aim 2: To compare RSPs and traditional prostheses with respect to injury risks~     associated with running~      Hypothesis 1a: RSPs will outperform traditional prostheses at all velocities as measured by~     kinetic data (ground reaction forces, joint powers, joint and limb work) and 50m dash time.~      Hypothesis 1b: ILEA intact limbs and able-bodied control limbs will outperform residual~     limbs with RSPs and traditional prostheses at all velocities as measured by kinetic data.~      Hypothesis 2: Running with RSPs will show reduced acute and chronic injury risks compared to~     traditional prostheses at all velocities as measured by loading rates, EMG amplitudes,~     lumbopelvic kinematics, and modeled joint loads.~   "
13958|NCT02874586|"~     An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination~     of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).~   "
13901|NCT02875327|"~     Background:~      The SEER database collects data about people with cancer. SEER stands for Surveillance,~     Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who~     have low income or serious medical needs. Many studies have shown that Medicaid recipients~     with cancer are more likely to be diagnosed later in the disease than people with other~     insurance. They are also less likely to get treatment. Researchers want to compare Medicaid~     data and SEER data. They want to make this available to other scientists.~      Objectives:~      To link people in the SEER database to Medicaid data for the years around their cancer~     diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.~      Eligibility:~      No people are enrolled in this study.~      Design:~      The SEER finder file will be securely uploaded to the CMS Data Center.~      The finder file will be matched against the Medicaid Personal Summary file at the CMS Data~     Center.~      If participants appear in both the SEER file and Medicaid file, their data will be~     extracted.~      The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers~     will see if the Medicaid dates fall in certain periods. These are 12 months before, the~     month of, and 11 months after diagnosis.~      If participants are eligible for Medicaid for these periods, a flag will be created in the~     file. It will note the participants is eligible and why.~      The SEER finder file will be destroyed.~      The only data saved will be:~      Each participant's unique random SEER case number linked to their Medicaid number~      Monthly flags about Medicaid eligibility~   "
13902|NCT02875314|"~     This is a prospective randomized clinical trial, to determine whether dose-intensive tandem~     Consolidation, in a randomized comparison with single cycle Consolidation, provides an~     event-free survival (EFS) and overall survival (OS). The study population will be high-risk~     patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with~     central nervous system (CNS) embryonal tumors completing Head Start 4 Induction. This~     study will further determine whether the additional labor intensity (duration of~     hospitalizations and short-term and long-term morbidities) associated with the tandem~     treatment is justified by the improvement in outcome. It is expected that the tandem (3~     cycles) Consolidation regimen will produce a superior outcome compared to the single cycle~     Consolidation, given the substantially higher dose intensity of the tandem regimen, without~     significant addition of either short-term or long-term morbidities.~   "
13903|NCT02875301|"~     This randomized control trial will examine whether a 12 month monitored exercise~     intervention improves brain health in cognitively normal older adults. This trial will also~     address several important unanswered questions: (1) Are the recommended public health~     guidelines of 150 minutes/week of exercise sufficient for improving cognitive performance?~     (2) Does exercise influence brain structure and/or function? (3) Is there a dose-response~     effect of exercise on the above variables such that greater amounts of exercise brings about~     greater benefits in cognitive and brain health? (4) What are the mechanisms by which~     exercise influences brain health? and (5) What factors attenuate or magnify the effects of~     exercise on brain and cognitive health and contribute to the individual variability in~     intervention outcomes?~   "
13904|NCT02875288|"~     Aim: To compare the postoperative outcomes after surgical infiltration with plain~     bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally~     invasive, general surgery procedures. To the investigators knowledge, there are no~     head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus~     liposomal bupivacaine to evaluate postoperative pain and return of function.~   "
13905|NCT02875275|"~     This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3~     possible test meals (Grass Jelly). The participants will have the option to voluntarily~     choose which study part(s) to participate. This study will be evaluated on 40 healthy~     Chinese male subjects from the general public over a period of one year.~   "
13906|NCT02875262|"~     Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological~     deterioration is an important cause of mortality and morbidity. These secondary changes, so~     called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react~     to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and~     are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been~     evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients~   "
13907|NCT02875249|"~     Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients~     for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side~     effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models~     of GI mucositis pathophysiology are generally silent on the role of the intestinal~     microbiome.~      The aim of the study is to identify functional mechanisms by which the intestinal microbiome~     may play a key role in the pathophysiology of GI mucositis, the investigators applied high~     throughput DNA-sequencing analysis to identify microbes and microbial functions that are~     modulated following chemotherapy.~   "
13908|NCT02875236|"~     Efficacy and safety of octaplasLG® administration vs. crystalloids (standard) in patients~     with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial.~   "
13909|NCT02875223|"~     Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion,~     First-In-Human (FIH) clinical study of CC-90011 in subjects with relapsed and/or refractory~     solid tumors (including neuroendocrine carcinomas (NEC)) and Non-Hodgkin's lymphomas (NHLs).~     The dose escalation part (Part A) of the study will explore escalating oral doses of~     CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011.~   "
13910|NCT02875210|"~     Actually, there are several laximeters for measuring anterior tibial translational in case~     of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and~     Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters~     values), have a bad correlation between them and so are not comparable in current~     literature. The aim of this study was to compare results of these tests and establish a~     ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each~     instrumented test.~   "
14036|NCT02873572|"~     Addictions without substances are an emergent problem giving rise to a recent and increasing~     request of care. Among these new addictions, pathological gambling and pathological online~     video gaming which are up. The purpose of this study is to identify vulnerability factors~     (personality traits, decision making strategies...), which are common or specific to each~     type of game (on line poker, casino, MMORPG, and no-gamers).~   "
13913|NCT02875171|"~     Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced~     cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure~     treatment can potentially reverse cardiac dysfunction at the early stage of cardiac~     toxicity, early detection of AIC is crucial.~      Transthoracic echocardiography is recommended for monitoring left ventricular function in~     patients receiving these molecules. In routine practice, left ventricular systolic function~     is mainly assessed by the left ventricular ejection fraction (LVEF), measured by~     two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience~     and is not sensitive enough to detect subclinical myocardial dysfunction.~      To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed.~     This technique allows for a study of global and regional myocardial deformation, especially~     the longitudinal component, which appears to be the most sensitive one. Several studies have~     already emphasized the role of global longitudinal strain (GLS) to detect slight alterations~     in systolic function, especially in the setting of potentially cardiotoxic drugs and even~     after low to moderate doses of anthracyclines. A recent expert consensus paper strongly~     recommends GLS assessment for the detection of subclinical left ventricular dysfunction due~     to anthracycline therapy.~      Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few~     data exist on the optimal timing to perform echocardiography.~      The investigators hypothesized that very early measurement of GLS in the time course of~     anthracycline therapy could predict subsequent left ventricular systolic dysfunction.~      The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m²~     of anthracyclines can predict AIC.~   "
13914|NCT02875158|"~     Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce~     intraocular pressure in case of glaucoma. Due to concerns over complications, the main~     indications for this second-line treatment are refractory glaucoma medication / surgery and~     low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the~     majority of researchers and clinicians according to the published literature. Some have~     proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.~      The aim of this study is to determine how different parameters affect the efficacy of the~     treatment. This is a prospective double-blinded randomized controlled trial comparing two~     groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000~     mW for 2 seconds.~   "
13915|NCT02875145|"~     The follow up time after keratoplasty now routinely exceeds multiple decades. It is common~     for keratoplasty patients to also undergo cataract surgery at a later date in their lives.~      Keratoplasties and cataract surgery both result in local inflammation. This may influence~     the density of endothelial cells, and on average there is a loss of 10% in endothelial cells~     within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is~     required to maintain graft transparency. It may be therefore difficult to strike a balance~     between loss of visual acuity due to the cataract of to the loss of graft transparency over~     the long term.~      The investigators aim to compare graft survival in patients with clear crystalline lens with~     and without cataract surgery.~   "
13916|NCT02875132|"~     To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR)~     and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with~     acral lentiginous melanoma treated with pembrolizumab~   "
13917|NCT02875119|"~     This is a two-part study. The first part is a single-dose open label design. The second part~     employs a multiple dose, randomized, placebo controlled study design. Studies have~     demonstrated that GRFT is highly potent for HIV prevention and is effective at very low~     concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal~     concentration of GRFT for the prevention of HIV, based on preclinical data, will be~     evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be~     minimally absorbed systemically, if at all.~   "
13918|NCT02875106|"~     The primary objective in this study is to identify commercial pulse detection systems (CPDS)~     parallel to electrocardiogram (ECG) recording within routine clinical setting, which are~     able to detect atrial fibrillation or sinus rhythm of screened patients.~   "
13919|NCT02875093|"~     Assessment of safety and tolerability of drug combination and determine time on treatment,~     Overall survival (OS) and response rate with patient disease burden, and type of disease~   "
13920|NCT02875080|"~     The ratios of the geometric means of the ODT formulation to those of the reference~     formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of~     brexpiprazole (OPC-34712)).~   "
13921|NCT02875067|"~     This trial is to assess the safety & efficacy of the Combination of Pembrolizumab and~     Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.~   "
13922|NCT02875054|"~     Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as~     compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP)~     following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and~     hand-arm bimanual intensive training (HABIT).~   "
13923|NCT02875041|"~     This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic~     stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in~     Parkinson's disease patients.~   "
13924|NCT02875028|"~     Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet~     inhibition may also exert positive results on coagulation activation and may beneficially~     influence the inflammatory response. Since vorapaxar is the first available substance of a~     new class of platelet inhibitors its effects on the human coagulation system and the~     inflammatory response will be assessed in the well-established human endotoxemia model.~   "
13925|NCT02875015|"~     Postoperative pain, the quality of their recovery and the opioid consumption following a~     midurethral sling placement are being compared between 2 groups. One group will have the~     hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group~     will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine~     solution.~   "
13926|NCT02875002|"~     This phase 1, multicenter, open-label study is designed to find the RP2D of volasertib, a~     PLK1 inhibitor, and belinostat, an HDAC inhibitor, when given in combination to patients~     with relapsed or refractory B-cell or T-cell lymphoma. A standard 3+3 dose-escalation design~     will be employed with study enrollment beginning at dose level 1.~   "
13927|NCT02874989|"~     The purpose of this study is to determine whether dasatinib and quercetin can reduce the~     expression of pro-inflammatory cells obtained by skin biopsy.~   "
13928|NCT02874976|"~     Interventional~   "
13929|NCT02874963|"~     This intervention study is designed to evaluate the effects of non-surgical procedure in~     addition to surgical procedure on systemic inflammation and glycemic control in with type 2~     diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic~     patients.~   "
13930|NCT02874950|"~     Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and~     shoulder areas, are some of the most common issues among office workers. The Social Security~     Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at~     a maximum of 10,000 per year.~      Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a~     sample of office workers; 2. Test effective methods of reducing lower back, neck and~     shoulder pain in this sample by training exercise, or ergonomics modification, or both of~     them; and 3. Assess discomfort scores and the range of motion of the lower back, neck and~     shoulder muscles among the office workers after undertaking the different methods for a~     period of 6 months.~      Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and~     forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from~     3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups~     (receiving training exercise, receiving modified ergonomics, receiving a combination of~     exercise and ergonomics modification) and a control group (receiving none of these~     interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal~     discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of~     the interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were~     measured by a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived~     exertion of training exercises. The rapid office strain assessment (ROSA) questionnaire was~     used to assess the strain associated with office work. Height and weight were also measured~     to calculate the body mass index (BMI).~   "
13931|NCT02874937|"~     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and~     probably is responsible for CDN $250 million in health care spending each year.There is no~     known medical treatment for frequent fainting. Two randomized studies suggest that~     inhibition of norepinephrine transport (NET) reuptake with sibutramine and reboxetine (NET~     inhibitors) prevents syncope on tilt testing by about 80%, and the investigators reported~     that sibutramine markedly reduced the frequency of vasovagal syncope in 7 of our most~     symptomatic patients. Sibutramine and reboxetine, for different reasons, are not available~     in Canada. However atomoxetine is available and is used to help patients with attention~     deficit disorder. There are no data pertaining to its hemodynamic effects in patients with~     vasovagal syncope. Although a randomized clinical trial of atomoxetine for the prevention of~     vasovagal syncope would be needed before clinical use, the investigators first need a proof~     of principle study. The objective is to determine in a prospective, randomized, parallel,~     double-blind study if atomoxetine 40 mg bid in patients at least 18 years old with recurrent~     vasovagal syncope will better prevent syncope during tilt testing than placebo.~   "
13932|NCT02874924|"~     The ability to mount an effective immune response declines with age, leaving the elderly~     increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug~     to prevent transplant rejection, increases the lifespan and healthspan of mice and~     ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in~     laboratory animals. Investigators are conducting a translational trial to test whether~     rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).~   "
13933|NCT02874911|"~     Exergame training might offer a novel treatment approach even in largely nonambulatory~     subjects with multisystemic degenerative spinocerebellar ataxia.~   "
13934|NCT02874898|"~     This study examines how marijuana use affects processes related to recovery from chronic~     posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic~     PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana~     use. This study will assess how individuals with PTSD with heavy or no marijuana use perform~     on a discriminative conditioning and extinction paradigm designed to measure fear extinction~     learning, and how they respond to a brief daily imaginal exposure treatment in regards to~     PTSD symptom reduction.~   "
13935|NCT02874885|"~     Objectives:~        -  To establish the rate of circulating tumor cells (CTC) positivity in patients with~          locally-advanced rectal cancer (LARC), relative to other stages;~        -  To assess changes in detected CTCs associated with neoadjuvant therapy in patients with~          LARC;~        -  To correlate CTC counts with neoadjuvant treatment response as an indicator of disease~          risk.~   "
13936|NCT02874872|"~     The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary~     antibiotic use in skilled nursing facilities. The first target of intervention is the tasks~     carried out by nursing staff after a change in condition and after an antibiotic~     prescription is initiated. The second target are the management staff who provide feedback~     to staff. The third target are the administrators who identify and overcome organizational~     barriers to implementation.~      In this study, we will implement two tools that are intended to minimize unnecessary~     antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility~     staff assess risk and communicate with prescribers when residents experience a change in~     health status that may result in the use of antibiotics. The second tool is used after an~     antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides~     prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions,~     narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic~     therapy.~   "
13937|NCT02874859|"~     This a non-interventional retrospective study on the efficiency and the tolerance of~     intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema~   "
13938|NCT02874846|"~     To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal~     Intraocular Pressure.~   "
13939|NCT02874833|"~     A randomized single-blinded prospective study to evaluate the efficacy of an individualized~     supervised 8-week exercise program in subjects with moderate to severe depressive episodes~     compared to treatment-as-usual~   "
13988|NCT02874196|"~     The purpose is to determine diagnostic performances of flat panel dual energy arthrography~     and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as~     reference the results of surgery performed 6 months after arthrography.~      Secondary purposes are:~        -  To describe the level of concordance of each technique with the indication for surgery~        -  To study inter-technique concordance with kappa coefficient~        -  To study the relationship between density differential between 2 acquisitions and grey~          level on subtraction, i.e. subtraction quality according to metal~   "
13940|NCT02874820|"~     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the~     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric~     conditions such as depression and addiction, along with neurodegenerative disorders such as~     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated~     functional interactions with the opioid system, where I2BS ligands have been shown to affect~     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.~     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic~     effects in different models of pain.~      The location of I2BS on astrocytic glial cells and the possibility that they may in some way~     regulate glial fibrillary acidic protein have led to increased interest into the role of~     I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has~     been shown to increase in Alzheimer's disease post mortem, and it has also been suggested~     that I2BS may be a marker for the severity and malignancy of human glioblastomas.~      The lack of suitable imaging tools for the I2BS has meant that information regarding the~     number and distribution of I2BS in the brain has come from preclinical species and in vitro~     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to~     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional~     distribution in the living human brain. In this study the investigators plan to utilise~     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo~     using PET.~   "
13941|NCT02874807|"~     Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of~     antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water~     retention and secondary natriuresis and is a common cause for hyponatremia.~      The therapeutic options, aside from treating the underlying disease, depend upon the onset~     and severity of the symptoms and involve usually fluid restriction or hypertonic saline~     infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or~     vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable~     number of patients which do not sufficiently respond, making additional therapy necessary.~      Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is~     a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is~     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered~     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent~     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with~     hypotonic hyponatremia as in SIADH.~      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the~     serum sodium levels of patients with SIADH.~   "
13942|NCT02874794|"~     To determine whether treatment with sacubitril/valsartan provides a superior effect on~     aortic characteristic impedance compared to enalapril in patients with heart failure and~     reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) after 12 weeks~     of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc =~     dP/dQ in early systole) between baseline and Week 12.~   "
13943|NCT02874781|"~     This study measures the sublingual microcirculation of patients with kidney transplant using~     MicroScan. The data will be compared with data of health volunteers and end stage renal~     disease patients on hemodialysis.~   "
13944|NCT02874768|"~     This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will~     be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group.~     In the dexmedetomidine group, patients will receive continuous intravenous infusion of~     dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients~     will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6~     mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with~     chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data~     such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be~     recorded. The microcirculation will be examined by Cytocam. The following microcirculatory~     parameters will be investigated: total small vessel density, perfused small vessel density,~     microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays~     will be used to measure serum level of endocan, diamine oxidase, and neutrophil~     gelatinase-associated lipocalin at preset time points. The primary goal of this study is to~     compare the effect on microcirculation between dexmedetomidine and propofol in intensive~     care unit patients after abdominal surgery.~   "
13945|NCT02874755|"~     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency~     (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in~     the private health sector of Mumbai city, India.~   "
13946|NCT02874742|"~     The purpose of this study is to determine if the addition of daratumumab to~     lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of subjects~     achieving stringent complete response (sCR), as defined by the International Myeloma Working~     Group (IMWG) criteria, by the time of completion of post autologous stem cell~     transplantation (ASCT) consolidation treatment, compared with RVd alone.~   "
13947|NCT02874729|"~     Tumour biomarkers are substances produced by cancer or by other cells of the body in~     response to cancer conditions. They are used to help detect, diagnose, manage and predict~     outcome or recurrence of some types of cancer. Tumour biomarkers can also help doctors~     choose the most appropriate therapy or judge if treatment is successful. Several tumour~     biomarkers are already used in the clinic; however, many others do not meet rigorous~     scientific standards to enter into clinical practice and some solid cancers can be only~     detected using tissue biopsy, a rather invasive procedure. Likewise, evaluating efficacy of~     novel therapies during clinical trials relies on adequate and specific laboratory tests.~     Therefore novel biomarkers and novel methods, to measure them, still represent an un-met~     clinical need.~      This study aims to develop innovative, more sensitive and reliable tests for better targets,~     in order to assess and monitor circulating cancer biomarkers. Easily accessible samples,~     like blood, will be tested such that invasive tissue biopsies can be avoided. Both healthy~     individuals and cancer patients will be recruited in this study to establish if a laboratory~     test is powerful enough to distinguish between individuals that may have cancer or not.~     Participants' involvement will also support development of novel tests to decide if a novel~     therapy is efficiently counteracting cancer growth or not.~      Participants in the study will be asked to donate blood, sputum, urine or other body fluids,~     depending on the cancer and the assay being developed. After participants give their~     informed consent, the researchers will isolate cells, soluble factors or nucleic acids from~     body fluids. Researchers will then use various laboratory techniques to screen cells,~     soluble factors or nucleic acids for specific markers. This study looks at the effectiveness~     of using laboratory tests to quantify tumour markers in body fluids and, subsequently, to~     monitor patients' response to treatments.~   "
13948|NCT02874716|"~     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency~     (PPIA) program on quality of health care. The PPIA is a tuberculosis pilot program~     implemented in the private health sector of urban Patna in the state of Bihar, India.~   "
13949|NCT02874703|"~     In this study, investigators plan to test two potential mechanisms contributing to diastolic~     dysfunction among asymptomatic persons with HIV who are on cART. The first proposed~     mechanism is that heightened systemic immune activation/inflammation in HIV contributes to~     myocardial inflammation, which in turn promotes myocardial fibrosis. The second mechanism is~     that ectopic fat deposition (increased visceral adiposity) in HIV relates to increased~     intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV~     positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for~     evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid~     content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and~     markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS~     outcomes.~   "
13950|NCT02874690|"~     The overall goal of this research is to use neurophysiological measures to profile strengths~     and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum~     Disorder to clarify diagnosis and to predict treatment response.~   "
13951|NCT02874677|"~     Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous~     system. In France, it concerns approximately 80 000 patients and represents one of the most~     frequent neurological affections in young adults. Effort deconditioning of people affected~     by MS is already proven, but it is not just linked to the disease itself. The decrease of~     capacities to produce an effort is aggravated by neurovegetative and cardiovascular~     disorders. The limitation or the complete stop of physical activity is often linked to the~     fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance~     disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated~     by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and~     alter significantly the quality of life.~      Some reeducation programs were proposed in hospitalization with some efficiency on~     functional capacities. It is now admitted that physical exercise is not noxious, and allows~     the implementation of effort reeducation for MS. Randomized controlled studies have shown in~     MS patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of~     life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort~     reeducation on treadmill. Unfortunately, the efficiency of these programs on walking~     endurance are controversial.~      During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1)~     corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows~     the precise determination of the limit from which the body is incapable of producing the~     necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a~     level of load with enough intensity for the subject to support the test without dyspnea. A~     VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to~     effort due to dyspnea and excessive muscular fatigue. This indication is very informative~     about the quality of life of patients.~      The goal of this study is to apply a personalized reeducation concerning the working load~     pre-hyperventilation to deconditioned subjects, easily worried by effort induced~     breathlessness and fatigue in order to get the optimization of the aerobic function. The~     hypothesis is that reeducation at this level improves the distance of walking and the~     quality of life of patients affected by MS.~   "
13952|NCT02874664|"~     Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular~     repolarization in subjects with small cell lung cancer (SCLC).~   "
13953|NCT02874651|"~     This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have~     residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The~     purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an~     inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the~     survival in these patients treated with apatinib versus placebo (phase IIb).~   "
13954|NCT02874638|"~     Protein requirements in individuals who participate in endurance-based exercise training~     have been suggested to be greater than the current recommended dietary allowance (RDA).~      The biological value of protein depends on its amino acid composition. Essential amino acids~     are believed to have main role on whole body protein metabolism. However, it remains to be~     determined what role non-essential amino acids (NEAA) may have in regulating protein~     metabolism and contributing to the increased protein requirements after endurance exercise.~      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid~     requirement in children, normal healthy adult and clinical populations. However, the IAAO~     method has never been utilized for assessing the effect of NEAA on protein requirements~     after endurance exercise.~      The objective of the current study is to investigate the importance of NEAA for~     endurance-trained male subjects.~   "
13955|NCT02874625|"~     In this randomized clinical trial, the bio-compatibility of 2 materials used for dental~     restorations will be compared: glass-ionomer vs resin-based composites.~      Urine and saliva samples will be taken for determination of bisphenol A levels at several~     time points, and for analysis of the estrogenic activity using ERE-CALUX.~      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit.~     Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined~     using UPLC-MS/MS.~   "
13956|NCT02874612|"~     Background: The often studied psychosocial correlates that relate to health outcomes in~     adolescents with Type 1 Diabetes (T1D) are factors such as self-efficacy, depression,~     distress, quality of life, and adherence. These psychosocial factors are not well-studied~     within a young adult (YA) population and the parents of YAs during the transition planning~     phase. Impact: This study aids program development for pre-transfer educational~     interventions to ensure more successful post-transfer health outcomes from both a patient~     and parent perspective. Methods: This longitudinal study is designed to characterize the~     psychosocial factors relevant for a population of YA with T1D. Data analyses of these~     psychosocial and transition readiness variables allow for understanding of prospective~     health outcomes for young adults with T1D during the transition process. Implications/Future~     Directions: From a clinical perspective, the outcomes of this feasibility study will be~     two-fold: (1) establish which of the clinical measures used in the study are related to~     meaningful health outcomes in this young adult population in order to determine future~     standardized assessments in the Diabetes Center and (2) determine which psychosocial~     constructs are relevant to health outcomes to then more fully develop the Diabetes Center's~     transition program interventions to improve functioning clinic-wide (e.g., group day~     sessions). Finally, it would be attractive to various National Institutes of Diabetes and~     Digestive and Kidney Disorder (NIDDK) grant mechanisms to identify the relevant psychosocial~     measures that assess the psychosocial functioning of YA with diabetes after they transfer to~     adult care.~   "
13957|NCT02874599|"~     Adult patients who require multiple dental restorations will be included in this study.~     Urine and saliva samples will be taken for determination of bisphenol A levels at several~     time points, and for analysis of the estrogenic activity using ERE-CALUX.~      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We~     will determine global alterations in DNA methylation and DNA hydroxymethylation levels using~     UPLC-MS/MS.~   "
13959|NCT02874573|"~     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy~     of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients~     with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a~     recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the~     immunoglobulin G1 (IgG1) subclass. Tocilizumab is formulated as a concentrate for solution~     for infusion, and will be administered by intravenous infusion.~      The investigators propose a 12-week randomized controlled trial of tocilizumab, given in~     adjunct to antipsychotics, in N=20 stable outpatients with schizophrenia or schizoaffective~     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity~     C-reactive protein [hsCRP]>0.5 mg/dL). The investigators hypothesize that adjunctive~     treatment with tocilizumab will be associated with significant improvement in cognition~     compared to placebo in patients with schizophrenia, and baseline IL-6 levels are higher in~     tocilizumab-treated responders versus non-responders, and there will be greater decreases in~     hsCRP from baseline to week 12 in tocilizumab-versus placebo-treated responders, with~     response defined as ≥0.5 standard deviation (SD) improvement in cognition. Tocilizumab is~     administered as an intravenous infusion every 4 weeks. Following a screening evaluation,~     participants will receive three infusions of siltuximab, one at baseline, another at week 4~     of the study, and another at week 8. The investigators will measure changes in cognitive~     function and symptoms over a 12-week period. Complementing previous positive clinical trials~     of non-steroidal anti-inflammatory drugs, this would be a proof-of-concept study that~     targeting specific cytokines is a viable treatment for schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical~     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for~     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,~     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.~      On 11 January 2010, Tocilizumab was approved by the U.S. Food and Drug Administration (US~     FDA) as Actemra for the treatment of rheumatoid arthritis. The FDA approved tocilizumab for~     the treatment of systemic juvenile idiopathic arthritis for children from two years of age~     in April 2011.~   "
13960|NCT02874560|"~     In a population of patients suffering from schizophrenia being treated for an episode of~     clinical destabilization and followed for a period of twelve months, the main objective is~     to evaluate the proportion of patients achieving functional remission and its relationship~     to clinical remission.~   "
13961|NCT02874547|"~     Community Health Workers (CHWs) using patient stories to support hypertension management is~     a randomized controlled trial to evaluate the implementation of a CHW-delivered culturally~     appropriate storytelling intervention for english and spanish-speaking patients diagnosed~     with hypertension who receive care at community health center settings.~   "
13962|NCT02874534|"~     The overall goal of this project is to develop a novel transdiagnostic treatment for~     anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA), using ultra-high~     field functional neuroimaging. There is a critical need for a validated treatment that~     specifically targets anhedonia, and this project will evaluate the effects of this new~     treatment on anhedonia and will establish how this treatment impacts brain systems that~     mediate reward processing, clinical symptoms of anhedonia, functional outcomes, and~     behavioral indices of reward processing. This work will also identify brain targets by which~     future novel anhedonia treatment may be evaluated.~   "
13963|NCT02874521|"~     The purpose of the trial is to compare the effects of intra-dialytic low-frequency~     electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis~     without exercise training.~   "
13964|NCT02874508|"~     To analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a~     quantitative change in one or several leukocyte subpopulations and whether such changes are~     associated with perioperative cardio-vascular events.~   "
13965|NCT02874495|"~     Crohn's disease goes along with an alteration of the quality of life, even in remission and~     has a negative impact on stress management linked to the pain and the health. Conversely,~     stress and psychological variables play a significant role in the pathogenesis of this~     disease. These interrelations reflects the link between the brain and the digestive tract,~     called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface,~     relaying in a bidirectional way, informations between the digestive tract and the central~     nervous system (CNS).~      Visceral information can thus modulate the functionnement of CNS's areas involved in pain~     management but also in the management of emotional and cognitive behaviours. Yet, numerous~     work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a~     dysautonomia of the sympatho-vagal balance.~      Human brain respond by advance before and during the application of a painful stimulus that~     enable the organism to regulate its nociceptive system in order to handle the aversive~     stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain~     awareness.~      The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse~     in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension~     and anxiety, that could influence visceral perception (increasing it). Nevertheless, only~     few studies exists about the differential role of certain or uncertain anticipation of the~     pain, despite the fact that they are associated to different emotional, cognitive and~     behavioral responses, and the effect of anticipation on painful visceral perception, have~     not yet been studied for parents in remission of Crohn's disease.~      The main goal is to search during certain and uncertain visceral anticipation, induced by~     distension of an intra-rectal balloon for persons suffering from Crohn's disease in~     remission, compared to control subjects, with an MRI functional study~   "
13966|NCT02874482|"~     Background:~      Patients with schizophrenia are abnormally disturbed by information onsets, which may result~     in a disadvantage in filtering relevant information. It seems that they accord the same~     importance to all objects in a scene without taking into account the relevance of objects~     (cognitive salience) or their emotional charge (salience emotional).~      The paradigm of change blindness offers the interesting possibility of studying sensitivity~     to the sudden irruption of visual information with ecological stimuli in schizophrenia. An~     increased attentional capture by the irruption of visual information would suggest better~     performance in patients than in healthy controls. Moreover, patients are disturbed to~     processing of emotional information, in this way we would like to measure the impact of~     emotional salience on the visual exploration.~      Main aim:~      The main objective is to evaluate, if patients with schizophrenia quickly detect changes~     occurring on irrelevant objects in the understanding of the scene.~      Secondary objectives:~      To evaluate in patients with schizophrenia the impact of emotional salience using the same~     paradigm.~      To separate an explicit response (motors responses) with an implicit response (eye tracking~     measures).~      Methodology:~      30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96~     scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants'~     speed and accuracy in explicitly reporting the changes via motor responses and their~     capacity to implicitly detect changes via eye movements.~   "
13989|NCT02874183|"~     To assess the effectiveness of pharmacist's provided education in HF patients, in improving~     patients' knowledge and self-efficacy, and to assess the impact of this intervention on the~     rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after~     discharge.~   "
14037|NCT02873559|"~     In this scientific clinical investigation, we will test whether testosterone and progressive~     resistance training can improve muscle strength and reduce the risk of falls in older men.~     In addition, we will examine whether this treatment improves quality of life, functional~     capacity, including sexual function and counteracts depression. Such a project have not been~     performed earlier.~   "
13967|NCT02874469|"~     Sudden death is a public health problem with more than 300,000 cases per year in USA and~     40,000 cases per year in France. Moreover, despite all recent therapeutic improvements~     (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains~     drastically poor and less than 50% of the patients admitted alive at hospital will survive~     to the event at 1 year.~      Outside all medications and technical care to improve patient prognosis, a psychological~     evaluation looks also critical to detect the occurrence of a post traumatic stress~     syndrome. In fact, along with the event severity, a variable period of amnesia related to~     coma may favor the occurrence of such a syndrome and psychological issues, which at the end~     may lead to impairment of patient quality of life.~      Previous studies have evaluated the impact of an intensive care unit diary on psychological~     distress in patients and relatives in the context of severe traumatisms. Such an evaluation~     has however never been done in the specific setting of sudden death and the frequency of~     this syndrome is unknown in this context.~      Aim The aim of the present study is to evaluate the impact of an intensive care unit diary~     on the occurrence of a post traumatic stress syndrome after a sudden death.~      Secondary objectives~        -  To evaluate the frequency of the occurrence of a post traumatic stress syndrome and~          other psycho traumatic symptoms after sudden death~        -  To evaluate the impact of an intensive care unit diary on the severity of this~          syndrome, psycho traumatic symptoms, and psychopathologic comorbidities~        -  To evaluate the impact of the diary on psycho traumatic symptoms and their severity in~          patient's relatives~        -  To evaluate the satisfaction of the patients and their relatives regarding medical~          cares in both groups (with and without diary)~        -  Comparison of nurse diagnostic (psychological distress) and diagnostic made by~          dedicated personal with a specific formation in psychology~        -  Qualitative evaluation of the diary~        -  Evaluation of the paramedical feeling before and after the diary input in practice~   "
13968|NCT02874456|"~     The purpose of this study is to seek the presence of ZIKV in semen, to determine its~     localization and to assess the efficiency of spermatozoa processing methods to obtain virus~     free spermatozoa.~   "
13969|NCT02874443|"~     This project is a clustered randomized controlled trial of a knowledge translation~     intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent~     is to reduce the rate of cesarean section (CS) in first time mothers without increasing~     maternal or neonatal morbidity. The guidelines were developed from data from the Consortium~     for Safe Labor. The unit of randomization will be sites in Alberta that deliver~   "
13970|NCT02874430|"~     This phase II trial studies how well metformin hydrochloride works together with doxycycline~     in treating patients with localized breast or uterine cancer. Metformin hydrochloride may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Doxycycline may stop the growth of bacteria by keeping them from making proteins and~     minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving~     metformin hydrochloride together with doxycycline may be a better way in treating patients~     with localized breast or uterine cancer.~   "
13971|NCT02874417|"~     This investigation examines the efficacy of a 35 minute computerized psychoeducation~     protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor~     for the development and maintenance of various forms of psychopathology.~   "
13972|NCT02874404|"~     This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in~     treating patients with diffuse large B-cell lymphoma that has returned after a period of~     improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
13973|NCT02874391|"~     Use of arteriovenous fistula for IV drug administration is controversial and often~     prohibited by nephrologists. However, we have been using this method in our department for~     years now in order to keep the patients 'veins for other fistulas in the future. The aim of~     this study is to evaluate our practice and maybe provide a justification for a larger~     multi-center study given the importance of this subject in patients with chronic renal~     failure.~   "
13974|NCT02874378|"~     Postoperative renal function recovery is very important to value the operation quality after~     kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow~     rate and perioperative renal function. Some animal experiments have revealed its beneficial~     effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the~     effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing~     Cystatin C level and enhancing renal function after kidney transplantation.~   "
13975|NCT02874365|"~     A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and~     ulcerative colitis), FAP patients and healthy controls. Investigate the morphological~     characteristics of organoids, the expression of genes and proteins of the~     Wnt/APC/beta-catenin pathway within both ISC.~   "
13976|NCT02874352|"~     This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM)~     system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for~     dysphagia and aspiration for the intensive care population with tracheostomy. This pilot~     study aims to determine the incidence of dysphagia and aspiration risk in intensive care~     patients with tracheostomy and the investigators hypothesise that the incidence of dysphagia~     in intensive care patients with tracheostomy will be higher than in an age matched~     population.~   "
13977|NCT02874339|"~     The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is~     non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with~     acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the~     emergency department.~   "
13978|NCT02874326|"~     The purpose of this study is to determine whether long-acting octreotide is safe and~     effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).~      The study hypothesis is that octreotide is safe and will reduce transfusion requirements and~     endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal~     telangiectasias.~   "
13987|NCT02874209|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and~     peripheral motor neurons, characterized by the rapidity of its evolution (median survival of~     3 years). The pathophysiology of the disease is still poorly understood. Neuronal death~     results from several cellular mechanisms entangled, including mitochondrial dysfunction. The~     absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On~     the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium~     (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated~     with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction~     causing the accumulation in the sodium and calcium cell causing neuronal death. These~     studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease,~     stroke and brain tumors. They demonstrated that sodium MRI could be an effective and~     sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this~     study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral~     sclerosis.~   "
14066|NCT02873182|"~     A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to~     assess autonomic neural function during spinal and/or pelvic surgery in women and men.~   "
13979|NCT02874313|"~     Objectives: Main objective: To compare the percentage of patients with new microaneurysm or~     hard exudates after 12 months between the CPAP group and the control group. Secondary~     objectives: To compare the central macula volume, ganglion cell layer thickness and central~     fovea thickness at baseline and 12, 24 and 52 weeks after randomization between the two~     study groups; to compare the percentage of patients who have an improvement loss of visual~     acuity (more than or equal to 15 letters in patients with macular edema and more than or~     equal to five letters in patients without macular edema) among the baseline visit and the~     weeks 12, 24 and 52 between the two study groups; to compare the percentage of patients who~     reach a higher level of diabetic retinopathy at 54 weeks between the two study groups; to~     compare the resolution time of central macula thickness from the randomization between the~     two study groups; to compare the glycated hemoglobin at baseline and 12, 24 and 52 weeks~     after randomization between the two study groups; and to compare the serum levels of~     inflammatory cytokines, oxidative stress biomarkers, sympathetic tone, and intake regulator~     hormones at baseline and 12 and 52 weeks after randomization between the two study groups.~      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional~     treatment-controlled trial of 12 months of duration.~      Subjects will randomize to conventional dietary and pharmacological treatment or~     conventional dietary and pharmacological treatment plus continuous positive airway pressure~     (CPAP). Study subjects: Subjects 35 to 75 years with type 2 diabetes and a clinical~     diagnosis of mild diabetic retinopathy (with or without macular edema), better visual acuity~     from 20/40 to 20/320 letters and refraction with a spherical equivalent less than ± 5~     diopter.~      Efficacy variables: Thickness of the central sub-field, central subfield volume, ganglion~     cell layer thickness, and presence of clinical or subclinical macular edema, serous retinal~     or retinal pigment epithelium detachment, intraretinal cysts or haemorrhages assessed by~     optical coherence tomography; presence of cotton exudates, microhemorrhages, microaneurysms,~     , microvascular retinal abnormalities, or a vein/artery ratio > 2/1 in examination of ocular~     fundus/retinography; better corrected visual acuity; glycosylated hemoglobin (HbA1c);~     fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; lipid~     profile, troponin I, proBNP, homocysteine and C-reactive protein; systemic biomarkers of~     inflammation, oxidative stress, endothelial damage, sympathetic activity and~     appetite-regulating hormones and clinical questionnaires: short form (SF)-12, visual~     function questionnaire (VFQ25) and iPAQ.~   "
13980|NCT02874300|"~     People with memory problems can struggle with everyday activities and may stop doing things~     they want to do. They are more prone to accidents and have a higher risk of falling.~     Occupational therapists can advise how to do daily activities more easily and safely.~     Physiotherapists can teach exercises which increase activity and improve balance, and may~     help maintain memory.~      There is little research on how to make these interventions work for people with memory~     problems. The investigators have developed two activity and exercise programmes suitable for~     people with memory problems. The investigators will study them in a feasibility trial. One~     programme involves high-intensity supervision (50 visits over one year), the other~     moderate-intensity supervision (11 visits over three months). The investigators will compare~     these with standard falls prevention assessment and advice (1-3 therapist visits). The~     investigators will encourage participants to exercise by themselves or with family members~     over the year, and once the programme ends.~      People with early dementia or memory problems will be eligible for this study. If possible,~     the investigators will also recruit a family member. Participants will be recruited from~     memory clinics or the 'Join Dementia Research' register. The intervention will be delivered~     over a maximum of 1 year in their own homes. Researchers will visit to collect information~     at baseline and at 12 months. The investigators will measure ability in activities of daily~     living, activity, quality of life, memory and health service use. Participants will complete~     weekly falls diaries. Intervention persistence will be measured for 24 months.~      The investigators will conduct interviews and discussion groups to help develop the~     programmes, and understand how they work in practice ('process evaluation'). The~     investigators will also do initial work on health economic modelling, dissemination and~     implementation.~      Study findings will be used to refine the intervention, and inform a planned definitive~     randomised controlled trial.~   "
13981|NCT02874287|"~     The purpose of this study is to evaluate whether treated with hydroxychloroquine could~     improve therapeutic effect for patients with high-risk coronary artery disease.~   "
13982|NCT02874274|"~     This is a study to see whether participation in the Edmond J. Safra Interdisciplinary Home~     Visit Program for Advanced Parkinson's (HVP) increases the rate of age-appropriate~     vaccinations in people with advanced Parkinson's Disease (PD) and related disorders. This~     study will evaluate the impact of the HVP on the rate of common illnesses such as flu and~     pneumonia in patients with advanced PD and related disorders over the course of one year.~      As there is currently no data available on the baseline rate of vaccinations in either~     homebound or less disabled PD populations, investigators will seek to establish the baseline~     rate of vaccinations, barriers to getting vaccinated, and baseline healthcare utilization in~     these populations by piloting (Phase 1) and then implementing (Phase 2) a survey via~     telephone interviews. Investigators will then test feasibility of offering influenza and~     pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort~     (Phase 3), and will compare their pre- and post-intervention rates of both outpatient and~     acute healthcare utilization and self-reported illness.~   "
13983|NCT02874261|"~     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a~     diverse and growing list of disorders including cardiovascular disease. During WBPA,~     patients lie in the supine position on a bed that is capable of translating back and forth~     parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is~     best described as a form of passive exercise. The frequency of the translation (up to 180~     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by~     the patient or health care professional.~      The science behind the therapeutic effects of WBPA still remains largely unknown.~      We are observing how WBPA may impact on sleep and activity in individuals with PD~   "
13984|NCT02874248|"~     This study is conducted to evaluate the effect of single and multiple therapeutic and~     supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability~     and on cardiac repolarization, as detected by QT interval corrected with Fridericia's~     formula (QTcF).~   "
13985|NCT02874235|"~     This study compares music therapy with verbal psychotherapy (treatment as usual) in an~     outpatient psychiatric clinic for traumatized refugees. Based on positive results from a~     pilot study, the randomized clinical trial are a non-inferiority design to detect whether~     music therapy is not less effective than verbal therapy carried out by psychologists, and~     can serve as a complementary treatment modality (n=70).~      The participants are adult Arabic or Danish speaking refugees suffering from posttraumatic~     stress disorder (PTSD). The patients are referred to outpatient treatment by their medical~     doctor. Data collection takes place in three clinics in Region Zealand, Denmark. The music~     therapy method used are Guided Imagery and Music (GIM).~      Primary outcome is pre and post measures of HTQ (Harvard Trauma Questionaire) and secondary~     outcomes are pre and post measures of Quality of Life Questionnaire (WHO-5), Tension~     Dissociation Scale (DSS), Somatoform Dissociation Questionaire (SDQ) , Revised Adult~     Attachment Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and~     Substance P).~   "
13986|NCT02874222|"~     Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer~     and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors~     (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage~     breast cancer. The effectiveness of current therapy is widely recognized to be compromised~     by poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms~     (AIMSS), a syndrome that affects up to 40-50% of women who take these medications. The~     syndrome that was not recognized during the registration trials for this class of drugs, it~     can lead to discontinuation in up to 24% of women over 2 years. Knowledge that can be used~     to prevent discontinuation of these important agents because of severe AIMSS is urgently~     needed.~   "
13990|NCT02874170|"~     Drepanocytose disease is the first genetic disease in the world. It results in the synthesis~     of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to~     structural changes of red blood cells (RBC) which then take the shape of a sickle, become~     more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass~     destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with~     low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the~     microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the~     failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to~     life-threatening patients. Preliminary studies conducted on patients with drepanocytose~     disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in~     the supply and use of oxygen. To date, the translation of this metabolic remodeling in the~     muscle work is not known.~      This project's main objective is to evaluate muscle function in drepanocytose attempted~     patients. We hypothesized that muscle remodeling associated with sickle cell disease have a~     functional impact on strength and muscle metabolism. The main objective is to characterize~     the maximal voluntary plantar flexor muscles. The criteria for these targets will be based~     on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and~     sickle cell patients (HbSS) oxygen saturation.~      The strictly non-invasive approach proposed in this project will study the functional~     parameters of the muscle of sickle cell disease and the possible link with the clinical~     manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation~     and pH plays a major role.~   "
13991|NCT02874157|"~     Viral infections are only recently been investigated in patients on mechanical ventilation~     (MV) in ICU. It is especially the progress in the direct detection of these pathogens that~     allowed intensivists to try to assess objectively the impact of viruses in their patients.~     This is of course of viral infections Community (influenza virus, rhinovirus ...), but~     some viruses also occur under mechanical ventilation in immunocompetent adults. This is~     called viral infection nosocomial whose Herpesviridae are the most frequent and best~     studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary~     infection. This reactivation is explained by the fact that after a few days of mechanical~     ventilation appears immunoparalysis, which can make the bed of bacterial or viral~     infection.Several studies have compared the pp65 antigenemia for quantitative PCR in~     immmunodéprimés patients. For example, in transplant patients (solid organs), the~     sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57%~     and 81.6% respectively. No work, however, has to date compared these techniques in the~     intensive care patient. In a subject shortly epidemiological study, the sensitivity of the~     quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this~     same study shows that half of the positive PCR on the BAL are not accompanied by a positive~     antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never~     been validated to date in intensive care. Finally, no work has so far evaluated the~     diagnostic performance of quantitative PCR performed on BAL~   "
13992|NCT02874144|"~     To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving~     signs and symptoms of disease in patients with sinusitis.~   "
13993|NCT02874131|"~     This study is a randomized controlled trial comparing an integrated treatment, Behavioral~     Activation + Cognitive Processing Therapy (BA + CPT), to CPT alone among active-duty service~     members with posttraumatic stress disorder (PTSD) and comorbid major depressive disorder~     (MDD). Participants will complete assessor-administered and self-report measures at pre- and~     post-treatment assessments, as well as a 3-month follow-up. Additionally, participants will~     complete self-report measures of PTSD and MDD symptoms at each therapy session.~   "
13994|NCT02874118|"~     The frailty and frail elderly was defined in 2001 by Fried as a physiological state of~     heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3~     categories: frail, pre-frail and not frail. The prevalence of frailty in the general~     population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years.~     This concept is explored in some chronic diseases, in order to prevent the loss of autonomy~     and tailor the treatment. In the carrier population of HIV, a North American retrospective~     study showed the frailty syndrome manifested as early as 10 years before, than in the~     general population. Furthermore various studies show in this specific population, increased~     incidence of diseases linked to age, suggesting an accelerated and premature aging.~      objectives: The objective of this study is to determine the prevalence of frailty defined~     Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV~     infection.~   "
13995|NCT02874105|"~     The rotator cuff tendinopathy is very common and associated with degenerative or traumatic~     changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps.~     Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff~     which means a loss of mobility or strength. The origin of this pathology remains~     controversial and many causes have been evoked (subacromial mechanical impingement,~     degenerative changes, muscle imbalance…). The clinical impairment is not always the same and~     varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder.~     The first treatment of the rotator cuff pathology is always non surgical and consists in~     relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and~     physiotherapy. The aim of this management is to relieve pain and to restore the mobility and~     a good function of the shoulder.~      There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff~     tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the~     muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and~     which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of~     this approach is to augment the subacromial space in order to decrease the inflammation of~     the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering~     (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described~     (3C Concept for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality~     of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In~     order to simplify and to improve its reliability, a special device called Scapuleo® has been~     developed. The aim of this device is to help the physiotherapist to realize simultaneously a~     subacromial decompression, a specific strengthening of the rotator cuff muscles and an~     optimal activation of the lower trapezius and the anterior serratus.~      Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol~     for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.~      We proposed a prospective and randomized study. All the patients treated in our department~     for simple tendinopathy of the rotator cuff or partial thickness tear were included in this~     study after signed consent. The physiotherapy protocol consists in 20 sessions of either~     Conventional program (Control group) or Dynamic Humeral Centering (Study group). The~     clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and~     Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study~     hypothesis. The assessor of all outcomes was blinded to the interventions.~   "
14028|NCT02873676|"~     The purposes of this study were to investigate the prevalence and risk factors for~     sarcopenia in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification~     Project (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.~   "
13996|NCT02874092|"~     This is an open label study to assess the improvement in the Disease Activity Score for~     28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who~     have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria).~     There will also be a cross sectional analysis of baseline platelet activity in subjects with~     rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any~     study medication, and will only have one study visit.~      Patients will receive 90 mg ticagrelor orally bid. The patients will receive drug for~     30-days. Methotrexate dose will remain stable throughout the study duration.~   "
13997|NCT02874079|"~     Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis,~     linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200~     pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous~     dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in~     Europe. The incidence of the individual entities is slight significantly different within~     Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA~     and South America. The most common of these disorders is the bullous pemphigoid.~      A considerable progress has been made in the last years to elucidate the pathogenic role of~     autoantibodies in these diseases. To this end, various in vitro and animal experiments have~     been used to understand some basic pathophysiological mechanisms in these diseases. Further~     studies are currently being carried out to explain a precise elucidation of the disease~     process and to be able to treat the patients targeted later.~      At present, however, no data are available to explain why certain individuals develop the~     autoimmune disease and others do not. Epidemiological studies showed some triggers to the~     development of autoimmune dysregulation, e.g. drugs.~      Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the~     disease. A clear association with certain HLA regions have been shown in patients with~     pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the~     HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was~     described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear~     IgA dermatosis the association with HLA antigens is less pronounced. Another indication of~     the importance of the genetic background in these diseases can be elucidated from the~     observation of autoantibodies at a low concentration in healthy relatives of pemphigus~     patients.~   "
13998|NCT02874066|"~     Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake~     of antiviral therapy for these patients is limited in the era of interferon (IFN) plus~     ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and~     the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct~     acting antiviral agents (DAAs), several studies have indicated high rates of SVR and~     excellent safety profiles to treat patients with severe renal impairment. With regard to~     ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1)~     study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease~     (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7~     patients achieved SVR. Although the data confirmed the excellent safety and efficacy in~     HCV-1b patients with severe renal impairment, the patient number was small and the data with~     regard to treatment-expeirenced patients was lacking. Therefore, we aimed to evaluated the~     safety and efficacy of ProD for 12 weeks in trearment-naive and treatment-experienced HCV-1b~     patients receiving hemodialysis.~   "
13999|NCT02874053|"~     Background:~      People with cancer often have to make complex decisions about their treatment. For some of~     these decisions, they have to weigh the benefits of a treatment against its side effects.~     They may have to think about its potential to increase the risk of another disease. One~     example is hormone replacement therapy. That reduces a woman s risk of getting colorectal~     cancer, but it raises her risk of getting breast cancer. Researchers want to learn more~     about how people make tradeoff decisions like these.~      Objective:~      To learn about how people respond to information about hypothetical health and medical~     treatment options.~      Eligibility:~      Adults ages 18 70.~      Design:~      Participants will have one 30-minute visit.~      Participants will complete a series of short questionnaires. These will be about their~     beliefs and values. Some may be about cancer and heart disease risk. Participants ages 18 to~     29 will answer questions about sexual health.~      Participants will write a paragraph or two about a room in their house or about a life~     event.~      Participants will read a series of stories. These will describe different hypothetical~     health treatments.~      The stories describe a pill that lowers the risk of one health condition, but raises the~     risk for another. After each story, participants will note how willing they are to take the~     pill.~      Participants will answer questions about the information that they got. They will also~     answer questions about their health, beliefs, and opinions.~      Participants will do 2 attention tasks computer.~   "
14000|NCT02874040|"~     Study the efficacy of endoresection of the tumor scar or, when surgery is not possible,~     transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary~     enucleation~   "
14001|NCT02874027|"~     Microbiome studies may be highlighted as crucial in the development of depression for TBI~     patients. The microbiota-gut-brain connection may further provide an opportunity for~     microbiota manipulation to treat the TBI patients with depression.This study is to~     investigate whether exist the relationship between depression and circadian rhythm of~     patients with TBI or not and focus the study on the potential of the host-microbiota~     interaction in regulating depression.~   "
14002|NCT02874014|"~     The study is to examine a moderate hypofractionation regimen of proton beam therapy for high~     risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are~     treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the~     regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180~     centigray/fraction) simultaneously. The overall treatment time is 5 weeks.~   "
14003|NCT02874001|"~     Validation of the PO-BADO in its short and long versions that need a standardized validation~     process with the inclusion of 450 Patients~   "
14004|NCT02873988|"~     Airway epithelium integrity is essential to maintain its role of mechanical and functional~     barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its~     integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial~     repair may participate in airway remodelling. The objective was to determine if airway~     epithelial wound repair of airway epithelium is abnormal in COPD.~   "
14005|NCT02873975|"~     This research study is studying a checkpoint kinase 1 (CHK1) inhibitor as a possible~     treatment for advanced solid tumors that harbor genetic alterations in the homologous repair~     (HR) pathway or with genetic alterations that indicate replication stress.~   "
14006|NCT02873962|"~     This research study is evaluating two drugs called Nivolumab and Bevacizumab as a possible~     treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.~   "
14029|NCT02873663|"~     The investigators will test the validity of biomarkers for the detection of heavy alcohol~     use in patients with and without liver disease.~   "
14007|NCT02873949|"~     Etiopathology of periodontitis is complex and various risk factors are known :~        -  Bacterial factors: major risk factor. Although the presence of periodontopathogen~          bacteria is necessary for the onset of periodontitis, these microorganisms are not~          sufficient for progression of all periodontal disease.~        -  Immune factor: host immune response modulates the disease evolution to destruction or~          recovery. The most studied cytokine in periodontology is IL-1 that induces various~          immune reactions and bone resorption directly or indirectly through the stimulation of~          prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are~          responsible of the degradation of bone extracellular matrix.~      Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is~     modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells~     (TREM) whose role in periodontitis is unknown.~      The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers~     in infected sites and in healthy sites in patients affected by periodontitis.~      Other purposes are~        1. Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients~          affected by periodontitis and in healthy patients~        2. Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic~          periodontitis treatment~        3. Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and~          clinical signs of periodontitis~        4. Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment~        5. Description of presence of some bacteria in sites analyzed for soluble TREM-1 and~          TREM-2~        6. Search for the most observed bacteria in presence of high concentrations of soluble~          TREM-1 and TREM-2 before and after etiologic treatment~        7. Evaluation of the impact of psychological stress measured through salivary cortisol~          level in saliva on TREM-1 and -2 expression~        8. Evaluation of the impact of psychological stress through stress and anxiety~          auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations~          in crevicular fluid of healthy and pathologic teeth.~   "
14008|NCT02873936|"~     The primary objective of this study is to evaluate the effects of filgotinib versus placebo~     in adults with active rheumatoid arthritis (RA) who have an inadequate response to biologic~     disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.~   "
14009|NCT02873923|"~     The DATECAN-2 project aims at assessing the surrogate properties for OS of several~     time-to-event endpoints through meta-analyses of completed and published randomized~     controlled trials. Two main cancer localization are concerned: breast cancer and soft-tissue~     sarcomas. The impact of survival endpoints' definitions on the trials' results and~     conclusions will also be evaluated.~   "
14010|NCT02873910|"~     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for~     reduction of susceptibility to infections and other complaints after extreme physical stress~     (participation in a marathon).~   "
14011|NCT02873897|"~     In independent elderly people, the aim is to test recipes for different types of food from~     different countries (starter, main course with culinary aids, carrot purees, desserts and~     smoothies) likely to improve sensory acceptability of foods for elderly people who are~     dependent for their meals (persons for whom at least one meal per day is provided by a~     catering service - meals at home, old people's home). All of the recipes were developed~     thanks to the first two parts of the OPTIFEL project so as to take into account the needs of~     elderly people and recommendations in each country. The interest is to increase the~     sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional~     content of the foods, to meet the nutritional needs of this specific population with~     enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre)~     suitable for different cultures. This ongoing research is being conducted on 2-4 different~     variants of each type of product: the starter (a soup of legumes), the main dish (diced~     chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit~     smoothies.~      For each product family, two products will be selected for each country: the preferred~     product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins~     and minerals) and the standard product without enrichment.~      Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary~     aids, 2 carrot purees, 2 desserts and 1 smoothie~   "
14012|NCT02873884|"~     The first aim of this study is to test the effect of the case management on the evolution of~     therapeutic alliance in patients with first episode psychosis in comparison with traditional~     nursing. The second aim is to test the effect of case management on nurses' well-being in~     comparison with traditional nursing. The third objective aims to show if therapeutic~     alliance is associated with insight in patients and with clinical and demographic data.~   "
14013|NCT02873871|"~     Randomized clinical trial to compare radial artery patency after transradial coronary~     catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or~     therapeutic coronary catheterization will be prospectively enrolled in this single-center~     trial and will be randomized to radial hemostasis with TerumoBand® or a standardized~     compressive dressing with gauze and elastic bandage.~   "
14014|NCT02873858|"~     Malnutrition is a frequent problem in persons older than 65 years: the prevalence of~     malnutrition can reach 25 to 29% in persons living at home who require help, figures vary~     between 19 and 38% for those living in institutions, and finally, the prevalence of~     malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have~     attempted to explain modifications in attitudes, behaviour, the frequency of meals or~     nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this~     project is to test the hypothesis that perhaps it is not as much the capacity to perceive a~     smell or a taste that affects eating behaviour in the elderly as their ability to~     distinguish between smells or tastes on the one hand (perceptual processing), and their~     ability to correctly interpret a chemosensory signal on the other (cognitive processing).~   "
14015|NCT02873845|"~     Altered quality of life in patients with stage III or IV colon cancer is well known. At~     their sides, their spouse/partner must also cope with the suffering caused by the disease~     and the upheavals that it engenders, with the treatments, in the organization of their~     everyday life. The physical, emotional, social and financial impact of cancer in general and~     its treatment on care-givers has already been studied. However, there are no data concerning~     the objective burden, that is to say the nature and the magnitude of the care weighing on~     the spouse of persons with colon cancer. Objective is to develop and validate a~     questionnaire that can be completed by the spouse/partner of patients with stage III or IV~     colon cancer so as to evaluate the burden of the disease in everyday life. It will allow~     medico‐social professionals to identify spouses/partners in difficulty and the needs of~     patients so as to offer the best support.~   "
14030|NCT02873650|"~     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral~     dose in subjects with moderate and severe hepatic impairment.~   "
14031|NCT02873637|"~     The main objective of this study is to show that postoperative Total Knee Replacement (TKR),~     an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor~     quadriceps femoral perineural catheter that (KTF) infused with even low doses of local~     anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking~     of the knee feasible at the bedside.~      Patients will be randomized in two arms:~        -  catheter in position under sartorial (experimental group)~        -  femoral catheter (control group)~   "
14016|NCT02873832|"~     Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of~     species and are characterized by their chaperone function, thanks to their ability to~     prevent aggregation and to promote the renaturation/break down of damaged proteins. Among~     other targets, they also chaperone JAK2, a key step that is deregulated in signalling in~     myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a~     potent cytoprotective action through their multiples inhibiting effects on apoptotic~     processes.~      Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS~     cells.~      However, in vitro studies of different cell models have shown the interest of HSP90~     inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal~     models with results in terms of blood counts and overall survival. In addition, it seems~     that the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90~     inhibitors. Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of~     cell growth, even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors~     are known to stimulate the expression of other HSP, notably HSP27 and HSP70, which are,~     through their properties, tumorigenic and could lead to an escape phenomenon. Thus the~     combined use of several HSP inhibitors could be beneficial, and eventually present~     synergistic effects on the inhibition of tumour processes.~   "
14017|NCT02873819|"~     This is a multi-center, randomized, double-blind clinical trial to assess the safety and~     efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at~     high-risk following surgery and adjuvant chemoradiotherapy.~   "
14018|NCT02873806|"~     The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two~     iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two~     anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.~   "
14019|NCT02873793|"~     By analogy with the mouse, the activity of control pathways for transposable elements (TE)~     in foetal primordial germinal cells could prove to be a determinant for fertility in~     adulthood in humans. Moreover, defects in the control of transposable elements (TE) could~     also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal~     instability and tumorigenesis. In this context, the aim is to analyse a specific type of~     adult germinal testicular cancers, seminomas. Directly related to our research interest, the~     histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent~     of germinal cells normally present in foetuses. The investigator postulates that these~     similarities could also extend to the biology of transposable elements (TE), and in~     particular to the initiation of the control of these elements. The management of seminomas~     requires surgery, orchiectomy, which consists of the total excision of the affected~     testicles. Using high-resolution high-throughput sequencing techniques, we propose to~     analyse the control pathways of transposable elements (TE) in tumour samples harvested from~     surgical pieces in comparison with adjacent healthy tissue. The results obtained in these~     tumour samples will be compared with those in normal foetal gonad samples.~   "
14020|NCT02873780|"~     The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk~     test and the 3 minute step test, for COPD patients.~   "
14021|NCT02873767|"~     This study is designed to evaluate the safety and tolerability of single ascending doses of~     UCB4019 administered by subcutaneous injection in healthy subjects.~   "
14022|NCT02873754|"~     This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile~     intervention to target smoking-cessation and increase physical activity among low-income~     persons. The intervention is called Smoking Treatment and Exercise Program for Underserved~     Populations (STEP UP).~   "
14023|NCT02873741|"~     The purpose of this research is to study different strategies to identify women at highest~     risk for anal cancer. Primarily, investigators want to study a risk assessment called the~     Anal Cancer Risk Index; it gives women an overall number score based on risk factors that~     they may have for anal cancer, such as age, number of sexual partners, or smoking.~     Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are~     more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The~     study team will collect swabs of the cervix and the anus to study different laboratory tests~     that could identify women at highest risk of cervical and anal cancer. These laboratory~     tests include an anal pap smear, tests for markers of disease and tests that detect the HPV~     types most likely to cause cancer. The study team would like to see which of these~     laboratory tests do the best job at predicting precancerous lesions in the anus and are~     better indicators of risk for cancer. After collecting these swabs, women will have a~     procedure called high resolution anoscopy where investigators look closely at the anus and~     biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes~     that HPV can make in cells to see if these tests predict anal lesions.~   "
14024|NCT02873728|"~     The goals of this series of studies is to test the effect of RIC on chronic leg ulcers~     (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological~     mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled~     study.~   "
14025|NCT02873715|"~     This study is designed to translate an evidence-based family-based weight loss treatment for~     childhood obesity (FBT) into primary care settings using co-located interventionists to~     serve as a model for care delivered within a patient-centered medical home. FBT plus~     enhanced usual care (FBT+EUC) will be compared to enhanced usual care (EUC) alone, and the~     families will be followed for a 2 year period to assess between group differences in the~     targeted child and parent outcomes, weight changes in non-targeted siblings who are~     overweight/obese, parent and child changes in delay of gratification, and how these changes~     relate to weight loss, and the assessment of how provider attitudes predict their intention~     to use FBT in the future. The results of this study will inform future dissemination and~     implementation of FBT into primary care settings.~   "
14026|NCT02873702|"~     The purpose of this study is to determine the efficacy of dexlansoprazole compared to~     lansoprazole in healing erosive esophagitis (EE) in Chinese participants.~   "
14027|NCT02873689|"~     The purpose of this study is to determine the efficacy of dexlansoprazole compared to~     placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants~     with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).~   "
14038|NCT02873546|"~     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial~     Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal~     (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the~     application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated~     at short term (1 week post-treatment) and mild term (3 weeks post-treatment).~      After unblinding, patients who received placebo treatment could be received active tDCS.~   "
14039|NCT02873533|"~     The analysis of this study will achieve an improvement in the management of patients over 70~     years with adaptation of chemotherapy regimens after analysis of the subject and its~     psychosocial environment.~      The analysis of socio-economic impacts will implement actions to optimize the care of the~     elderly while emphasizing the value of management / cost of care.~   "
14040|NCT02873520|"~     To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat~     Advanced Gastric Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Gastric Cancer.~   "
14041|NCT02873507|"~     A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft~     steatosis prior to transplantation will be conducted. An MRI of the donor liver within the~     transport cooler will be obtained on its way to the operating room.~   "
14042|NCT02873494|"~     PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography~     (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to~     compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler~     echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.~   "
14043|NCT02873481|"~     This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in~     CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond~     Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will~     provide the necessary preliminary data to fuel an appropriately powered randomized~     controlled trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing~     stress resilience, and improving maternal-child outcomes among overweight/obese diverse~     women. Because increasing physical activity has been found to have important mental health~     effects and maternal-child outcomes, it stands to reason that this innovative intervention~     has the potential to impact the way prenatal care is delivered in high risk populations.~   "
14044|NCT02873468|"~     The purpose of this study is to evaluate the efficacy of three doses of fluticasone~     propionate oral (viscous suspension) on changes of eosinophilic infiltration in esophageal~     biopsies.~   "
14045|NCT02873455|"~     Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery.~     The investigators aim to evaluate the effect of video information on preoperative anxiety~     level in patients with colorectal cancer.~   "
14046|NCT02873442|"~     To evaluate the safety and effectiveness of cell therapy using precision cells Combined With~     TACE in Advanced Liver Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Liver Cancer.~   "
14047|NCT02873429|"~     This project focuses on whether nonspecific factors as well as patient characteristics~     contribute to treatment outcome differences. The project uses assessment instruments,~     computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement~     Information System (PROMIS®). The research team has recently developed and tested (using~     PROMIS methods) a set of instruments to assess non-specific factors in healing from the~     patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL)~     assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare~     Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward~     Complementary and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief,~     easy to use and understand, and are designed to apply to a broad spectrum of treatments and~     health conditions. In this project, the investigators aim to 1) evaluate whether HEAL~     predicts chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects~     based upon HEAL and PROMIS scores in integrative and conventional medicine settings, and 3)~     interview patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log~     for enhancing communication. The investigators will administer HEAL CATs and other PROMIS~     CATs (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients~     who are starting treatment for chronic pain in integrative medicine and conventional~     medicine settings. Follow-up assessments will be completed 2 and 4 months after baseline~     testing. The investigators will evaluate factors that may predict which patients judge~     themselves to be improved, the same, or worsened. Some of the possible factors that may~     contribute to improvement include HEAL scores, emotional distress, or the preference for CAM~     or conventional treatment. The investigators are also interested in learning whether~     patients find the assessments to be clear and useful. A subset of 50 patients and~     approximately 10 clinicians will complete interviews about the HEAL and PROMIS questions,~     and about the Pain Log developed by a patient advocacy group partner, the American Chronic~     Pain Association. By interviewing patients and their healthcare providers, the investigators~     hope to determine the clarity and acceptability of the HEAL and other assessments, and to~     learn whether HEAL and PROMIS summaries enhance patient-provider communication in the~     clinical partnership.~   "
14048|NCT02873416|"~     To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy~     to treat Advanced Lung Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Lung Cancer.~   "
14049|NCT02873403|"~     Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to~     aging and increasing obesity, the prevalence of KOA is expected to increase in the developed~     country in the next 20 years. KOA decreases quality of life of patients through chronic~     pain, joint stiffness, and reduced social activity, which influence emotional wellness as~     well. KOA has also impact on the biomechanics of the lower limbs, leading or amplifying the~     tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the~     medial knee joint loading may lead patients into a vicious circle by increasing knee pain,~     decreasing activities, increasing weight and disease progression. Knee brace is a~     non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the~     limb. However, the main issue is the poor compliance because of lack of effectiveness, more~     drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness,~     aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in~     design, 3D printing may resolve most of these complaints.~      This study aims to compare clinical and biomechanical effectiveness, comfort and patients~     complaints of a knee brace made by 3D printing to a conventional knee brace.~      The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead~     the experimental trial. They will recruit men or women (40 to 70 years old) suffering from~     medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period,~     they will wear 2 different knee braces for two weeks each with a 1-week period without knee~     brace between. Participants will have five visits to GCU: once for leg measurement to make~     knee braces and four times to fill questionnaires and perform gait analysis. Besides, they~     will wear activity monitor for 3 non-consecutive weeks.~   "
14050|NCT02873390|"~     To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat~     advanced cancer.~      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with relapsed or refractory cancer that has not responded to or~     has relapsed after standard treatment.~   "
14051|NCT02873377|"~     Construction workers have the highest rate of smoking among all occupations, and are~     frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with~     smoking to increase their health risks. Minority construction workers, in particular, have~     higher smoking and lower cessation rates compared to other groups, and they generally show~     lower access and participation in cessation and health promotion services. The number of~     Hispanic workers employed in the construction industry in the US has tripled in the past~     decade to 2.6 million (23% of all construction workers). This study will develop,~     administer, and evaluate a novel smoking cessation program in a hard-to-reach and~     underserved population of Hispanic male construction workers using using pilot cluster~     randomized clinical trial (RCT) to test the developed intervention for feasibility and~     potential efficacy.~   "
14052|NCT02873364|"~     Chronic spontaneous urticaria is an inflammatory disease which is characterized with~     intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent~     studies have suggested a role for vitamin D in modulation of immune system and pathogenesis~     of chronic urticaria.~   "
14053|NCT02873351|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in~     patients with AMD, and measure the effects on surrogate functional biomarkers of AMD.~   "
14054|NCT02873338|"~     The purpose of this study is to determine whether CX-01 when given together with standard~     induction and consolidation therapy for acute myeloid leukemia (AML) will increase the~     effectiveness of the induction/consolidation therapy. Three different doses of CX-01 will be~     studied and safety and tolerability will be assessed.~   "
14055|NCT02873325|"~     DESIGN:~      Disease registry - non-interventional.~      INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or~     cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.~   "
14056|NCT02873312|"~     Approximately 10 US Study Sites will participate over total 18 months Study population will~     consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3~     months.~      Primary Study Objective~        1. To assess efficacy of the StimRouter stimulation therapy in improving OAB symptoms of~          urgency and frequency as measured by Patient Voiding Diary when targeting the posterior~          tibial nerve~        2. To assess safety of the StimRouter therapy~      Secondary Study Objective~      To evaluate:~      Efficacy of the StimRouter stimulation therapy in decreasing specific OAB symptoms of~     urgency, frequency, and urinary urge incontinence as measured by the Global Response~     Assessment (GRA) and 7-day Patient Voiding Diary~      Study Design is prospective, multi-center, randomized, double-blinded~      Primary Endpoint The primary efficacy endpoint will be the difference between the~     investigational and control groups in proportion of responders, defined as a return to~     normal voiding (7-day average in voids/leak episodes < 8) OR > 50% improvement in average~     voiding frequency above 8 that patient had at baseline OR > 50% improvement in average~     number of moderate to severe urgency episodes at approximately three months after~     programming as measured by 7-day Patient Voiding Diary.~      Primary Outcomes:~        1. Proportion of responders based on Patient Voiding Diary~        2. Adverse Event Reports~      Secondary Endpoints:~      The secondary efficacy endpoint will be the difference in specific OAB symptoms of urgency,~     frequency, and urinary urge incontinence as measured based on (1) the difference in~     proportion of subjects in the investigational and control groups who have moderately or~     markedly improved overall response on a 7 level Global Response Assessment (GRA) at~     approximately three months after programming; and (2) the difference in responses on the~     7-day Patient Voiding Diary between the baseline visit and approximately three months after~     programming.~      Secondary Outcomes:~        1. Global Response Assessment (GRA)~        2. Urgency, frequency, and urinary urge incontinence as measured by Daily Patient Voiding~          Diary~   "
14057|NCT02873299|"~     The purpose of this study is to compare two slightly different methods of transcranial~     magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)~   "
14058|NCT02873286|"~     A total of 400 subjects will be recruited into five treatment subject groups à 80~     subjects.Subject will receive two administrations 4 weeks apart which will consist of~     MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).~   "
14059|NCT02873273|"~     The purpose of this study is to determine whether a longer duration, controlled, sustained~     release dexamethasone delivery system would be more effective in helping patients with~     osteoarthritis reduce their pain, remain functional, and delay their need for knee~     replacement.~   "
14060|NCT02873260|"~     This study will evaluate the ability of a single dose of the live attenuated recombinant~     tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against~     infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005~     vaccine.~   "
14061|NCT02873247|"~     Patients who test Helicobacter pylori positive, are treated with antibiotics. However, due~     to a number of factors (such as unknown treatment compliance, no standardized follow-up,~     ...), a relative low eradication-percentage was reported.~      Therefore, the investigators want to measure the anticipated improvement in~     eradication-percentage due to the standardized treatment schedules (1st line, 2nd line and~     further) and the optimized communication with the general practitioner and patients.~   "
14062|NCT02873234|"~     Chinese Medicine syndrome differentiation has been a prevalent therapy in China for~     thousands of years. It is based on patients' symptoms, pulse, tongue and coating on the~     tongue. Therefore, the syndrome of patients and corresponding Traditional Chinese Medicine~     (TCM) may vary.~      This multicenter prospective cohort studies the efficiency and safety of TCM compared with~     antidepressants. A total number of 4600 cases with primary depression are expected to be~     collected and divided into 3 cohorts based on the patients' requirement and choices.~     Patients in one group will receive TCM, and patients in the other two groups will~     respectively receive antidepressants only and integrated treatment of TCM and~     antidepressants. This study has 2 phases: treating period and the follow-up.~      The main purpose of this long-term study is to evaluate the efficiency of TCM compared with~     antidepressants in reducing relapse and suicide rate, changing lifestyle, improving patient~     compliance as well as the safety.~   "
14063|NCT02873221|"~     This study will evaluate the long-term safety and tolerability of intermittent treatment~     with ubrogepant for the acute treatment of migraine over 1 year.~   "
14064|NCT02873208|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     ALKS 3831 in subjects with schizophrenia.~   "
14065|NCT02873195|"~     This randomized phase II trial studies how well atezolizumab and capecitabine with or~     without bevacizumab work in treating patients with colorectal cancer that is not responding~     to treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in~     treating colorectal cancer.~   "
14069|NCT02873143|"~     The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most~     common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared~     with other types of knee pain is unknown.~      In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire~     on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically~     diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly~     selected adolescents who did not report knee pain in 2011, will be contacted again to gain~     insights into their prognosis.~   "
14070|NCT02873130|"~     Voice disorders in teachers have a significant impact on communication, quality of life, and~     economic costs to the healthcare system. We need to advance the prevention of voice~     disorders in teachers by testing an online telepractice model with synchronous (in~     real-time) and asynchronous (stored and accessed later) methods. The current study will~     investigate the effectiveness of the theoretically-driven Global Voice Prevention Model~     (GVPM) delivered by two methods; 1) online telepractice (synchronous and asynchronous) and~     2) traditional, in-person for vocally healthy physical education and vocal music student~     teachers. Effectiveness of the model will be assessed by voice-related measures captured~     daily on a smartphone app during student teaching, matching the asynchronous aspects of the~     telepractice model and representing the effects of vocal loading from teaching.~   "
14071|NCT02873117|"~     This is a multicenter, cohort study based on medico-administrative data from pathology~     laboratory registries and drug reimbursement files (CNAM-TS).~   "
14072|NCT02873104|"~     To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for~     circumferential reduction.~   "
14073|NCT02873091|"~     Sixteen million babies were born in 2010, approximately half were by cesarean. Labor~     analgesia should be the first choice for these parturients based on the consideration of~     security and humanization. However this labor analgesia rate is quite low in China (<5%)~     while in western country, this rate is up to 60%. Programmed intermittent epidural bolus~     (PIEB) is the latest technique for labor analgesia which has less neurotoxicity~     theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled~     epidural analgesia (PCEA) which is used most commonly. In that study, they reported less~     total local anesthetic consumption, fewer manual bolus doses and greater patient~     satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons~     of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied~     analgesia, and not adapted to the symptoms of motor block, such as inability to move their~     legs distressing, both are important reasons of refusing labor analgesia and preferring to~     cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more~     effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed~     to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in~     Chinese parturients.~   "
14074|NCT02873078|"~     This randomized controlled study aims to evaluate the efficacy of exposure-based~     Internet-delivered cognitive behavior therapy for children 8-12 years with Functional~     Abdominal Pain Disorders. The children participate along with their parents, who will also~     receive specific modules with information on how to support their children in the treatment.~     Predictors and mediators for treatment effects will be studied as well as the cost~     effectiveness of the intervention.~   "
14075|NCT02873065|"~     This study compared efficacy and safety of Ilaprazole based triple regimen therapy including~     Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the~     first line eradication treatment of H.pylori~   "
14076|NCT02873052|"~     The MyoVista system is a novel electrocardiogram technology that provides non‐invasive~     assessment of myocardial abnormalities by analyzing energy changes at the cellular level of~     the myocardium.~   "
14077|NCT02873039|"~     Over the past decade, advancements in therapies available for pulmonary hypertension (PH)~     have increased life expectancy for those who qualify and receive treatment. Yet,~     prognostication of these patients has remained a clinical dilemma. The application of the~     REVEAL registry predictive algorithm provides information about estimated 1-year survival~     but since invasive measurements from a right heart catheterization cannot easily be~     repeated, it is not feasible to continually use this longitudinally to assess the disease~     burden. Simple tests such as BNP has been shown to be very clinically relevant in short~     -term and long term prognostication and seems to correspond well to the right ventricular~     failure. Elevated right atrial pressures, and its estimation via IVC measurements predict~     poor survivorship in a recent retrospective analysis. As clinical measurement of jugular~     venous pressure is becoming less reliable, we aim to bring point- of-care ultrasound to the~     outpatient setting. Point of care ultrasound is widely used in the Emergency Department and~     Intensive Care Unit settings. By measuring estimated right atrial pressure (eRAP) via~     Inferior Vena Cava (IVC) measurements at outpatient clinic visits we aim to find a~     correlation with the existing and widely used B-type Natriuretic Peptide (BNP), that is~     collected at each visit as a part of regular care. These measurements can be followed~     longitudinally and may aid in prognostication. Data will be collected over the period of 1~     year at clinic visits. A composite endpoint (including death, hospitalizations for PH,~     addition of new PH specific therapy after a stabilization period of 3 months, lung~     transplant or atrial septostomy) will separately be collected. At the end of the data~     collection period, clinical data only will be collected for a additional 2 years via phone~     correspondence, chart review or at regular PH clinic visits.~   "
14078|NCT02873026|"~     Eye trauma is a leading cause of blindness and visual impairment. Penetrating injuries of~     the eye are more likely to result in poor vision and the main cause of this is a scarring~     response on the retina (proliferative vitreoretinopathy, PVR) The purpose of this study is~     to investigate the potential of an anti-inflammatory treatment (triamcinolone acetonide) to~     improve the outcome of surgery in eyes that have suffered severe trauma.There is good~     evidence from laboratory studies that additional steroid treatment into and around the eye~     at the time of surgery could reduce scarring by reducing inflammation and improve visual~     outcomes.~   "
14079|NCT02873013|"~     This study will target patients who have received a histopathological diagnosis of prostate~     cancer and who are undergoing treatment in various forms, including active PSA surveillance,~     surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey~     information about the patient at time of diagnosis, clinical staging, details of initial~     treatment, status of disease progression, and prognosis at the end point of the study. The~     purpose of the study is to clarify distribution of staging, the actual status of treatment~     choices and treatment outcomes.~   "
14080|NCT02873000|"~     To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With~     Shortness of Breath.~   "
14081|NCT02872987|"~     The GMALL registry serves the purpose of ALL research and quality assurance. The Registry~     collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical~     routine, whether or not the patient is treated within a clinical trial.~   "
14082|NCT02872974|"~     MySweetHeart Cohort is an observational study to assess the effect of gestational diabetes~     mellitus (GDM) on early life offspring's cardiovascular health.~      The primary objective is to assess the effect of GDM on the surrogate markers of~     cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical~     atherosclerosis). The secondary objective is to assess the effect of GDM on the~     cardiovascular structure and function during the fetal period and neonatal adverse~     cardiovascular risk factors.~      The main hypothesis is that offspring of women with GDM have a larger LVMI and a larger cIMT~     at birth (primary outcomes) compared with offspring of women without GDM. Further, other~     hypotheses are that offspring of women with GDM have more foetal cardiovascular alterations~     and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with~     offspring of women without GDM.~      My SweetHeart Cohort is linked to MySweetHeart Trial, a randomized controlled trial~     assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial~     intervention to improve the cardio-metabolic and mental health of women with GDM and their~     offspring. The principal investigators of this trial are Prof Jardena Puder and Dr Antje~     Horsch from Lausanne University Hospital.~   "
14083|NCT02872961|"~     PURPOSE: This study will evaluate the relationships between small intestinal bacterial~     overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal~     pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome~     (IBS), functional dyspepsia (FD), & functional abdominal pain (FAP), to better understand~     the role of SIBO in their pathogenesis. DESIGN & PROCEDURES: Cross-sectional study.~     Subjects: Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years,~     undergoing endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for~     IBS, FD, or FAP, without evidence of an organic etiology of abdominal pain upon routine~     laboratory, radiologic, endoscopic, histologic evaluation. Sample Size: At least 30~     patients, ≥ 15 with SIBO (i.e., positive small bowel aspirate culture and/or glucose breath~     hydrogen test), and ≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates,~     serum, breath samples, symptom questionnaire responses. Measures: 1) Immune activation &~     inflammation - measured by serum cytokine levels & small intestinal tissue inflammatory cell~     infiltration & cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker~     FACES™ Pain Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III~     Version. 3) Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS &~     POTENTIAL BENEFITS: Aside from the risks associated with routine endoscopy with biopsies,~     which would occur even without study enrollment, the risks associated with serum collection,~     one extra biopsy specimen collection, small bowel aspirate collection, completion of pain~     scales/ questionnaires, and the glucose breath hydrogen test for the purposes of the study~     are minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the~     relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS,~     FD, and FAP. Potential biomarkers to support the diagnosis of these FGIDs and novel targets~     for therapy, such as immune molecules and previously unrecognized bacterial phylotypes and~     species possibly contributing to disease pathogenesis, may be identified. Also, determining~     the reliability of the glucose breath hydrogen test vs. small bowel aspirate culture in the~     diagnosis of SIBO in this setting may enable the physician to avoid invasive and costly~     procedures in the diagnostic work-up of children with these FGIDs.~   "
14084|NCT02872948|"~     The main objective of this study is to estimate the intrinsic diagnostic qualities of the~     digital dPCR in the screening of T21 from a multicentrique sample of patients with~     pregnancies at high risk of T21 (risk > 1/250).~      The profit expected from this technique is to propose to the encircled women a screening~     more successful than that of the screening combined(organized) of the 1st quarter, simple of~     realization and in a moderate cost. We thus propose here an original alternative(alternate)~     method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent~     technical improvements and his(her,its) advantages medical - economic allow to envisage a~     reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in~     most of the laboratories. This pilot project could serve for the later development of a~     study of clinical validation multicentrique of large scale(big turntable ladder).~   "
14085|NCT02872935|"~     In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of~     crystalloids, with placing the spinal, along with administering a phenylephrine infusion and~     glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and~     good intra and post-operative pain relief.~   "
14086|NCT02872922|"~     Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This~     biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of~     regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle~     cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by~     technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and~     all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz~     ultrasound waveforms improved endothelial function in health volunteers and this~     vasodilation persisted for 20 min, which provided them with anti-inflammatory vascular~     effects. In subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia~     reduce NO bioavailability causing endothelial dysfunction. Low intensity therapeutic~     ultrasound is an electrotherapeutic instrument employed in musculoskeletal injuries that~     promotes endothelium-dependent vasodilation, and its mechanism of action has not been~     studied on DM2. The aim of our study is evaluate endothelial function of patients with DM2~     after different waveforms (placebo, continuous and pulsed) of therapeutic ultrasound.~     Therapeutic ultrasound is a electrotherapeutic instrument that can changes arterial~     endothelial function of subjects with DM2 because of NO bioavailability increasing, which~     implies anti-inflammatory and vasodilatory beneficial alterations for diabetic patients.~   "
14087|NCT02872909|"~     This study aims to examine whether the pain of topical photodynamic therapy (PDT) is~     significantly different when using low irradiance ambulatory light emitting diode (LED)~     devices compared with conventional higher irradiance hospital based LED light sources when~     used for superficial non-melanoma skin cancer. The investigators are also investigating the~     phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical~     trial.~   "
14108|NCT02872701|"~     This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected~     lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron~     emission tomography imaging based on standard of care. This study aims to assess the~     efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within~     the operating theater, and to assess the safety and tolerability of single intravenous doses~     of OTL38.~   "
14123|NCT02872493|"~     The purpose of this study is to determine whether or not the total length of small intestine~     effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to~     ten years postoperatively. Roux-en-Y gastric bypass and vertical sleeve gastrectomy will be~     the surgical groups in this study. We aim to determine if bowel length has a significant~     effect on long term weight loss or other nutritional deficiencies in this bariatric cohort.~   "
14088|NCT02872896|"~     Subjects will first have a blood pressure reading recorded on both arms using a non-invasive~     blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be~     recorded using the ClearSight monitor on each hand over a one-minute period. If mean~     arterial pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP)~     monitoring cuff or the ClearSight system differs by more than 10% from arm to arm, the~     subject will be excluded from the study.~      Before induction of anesthesia, the subject will be randomized to either:~      ClearSight group + usual clinical care: Information from ClearSight monitor will be~     available to the clinicians. According to ASA guidelines, usual blood pressure monitoring~     includes non-invasive blood pressure measurements every 5 minutes during a surgical case.~      Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor~     will not be available to the clinicians.~      Both patient groups will have continuous ClearSight monitoring and non-invasive blood~     pressure monitoring every 5 minutes. The difference will be in the intervention group data~     from the monitor will be available to the clinicians in the operating room, but in the~     control group data from the ClearSight monitor will not be available (blinded) to the~     clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor~     continuous blood pressure data will be recorded for each study patient and will be used for~     analysis.~      The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and~     will complete POMS morbidity surveys.~   "
14089|NCT02872883|"~     This is a pilot study that will eventually result in a main randomised controlled trial that~     will look at what management is associated with a higher rate of normal birth and a lower~     rate of chorioamnionitis (maternal infection) when women break their waters but labour does~     not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks~     gestation) is a physiological event that happens during labour. However, according to Gunn~     et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time~     between the rupture and the onset of labour is called latent phase and time wise is~     variable.~      Studies have showed no statistically significant differences in terms of neonatal infection~     or chorioamnionitis when the investigators induce labour with prostaglandins compared to~     when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number~     of confounding factors that might relate to the incidence of chorioamnionitis (maternal~     infection), the strongest predictor was having more than 8 vaginal examinations since the~     rupture of membranes and before delivery which was a stronger predictor than the duration of~     the latent phase. It is thought that by reducing the number of internal examinations,~     chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main~     RCT will compare clinical outcomes and maternal satisfaction when women consent to be~     randomized to four groups: (1) Active management and routine internal examinations during~     labour, (2) Active management and reduced internal examinations, (3) Expectant management~     and routine internal examinations, (4) Expectant management and reduced internal~     examinations.~      This application seeks ethics approval for the pilot phase to ensure that a definitive study~     can be undertaken appropriately. It is important to test that all the components work well~     individually and as a whole, to estimate sample size and ultimately to test the integrity of~     the research protocol before embarking on the main trial.~   "
14090|NCT02872870|"~     This study will help to better characterize oral and written language disorders and~     determine if these disorders are continuous or not. The participants ( dyslexic and~     dysphasic patients and control adults) will carry out an auditory lexical decision task~     during which an electroencephalogram (EEG) will be recorded.~   "
14091|NCT02872857|"~     The purpose of this study is to examine the effects of the study drug--Galantamine—on~     patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH~     will tolerate the study drug and how it may improve brain functioning in patients after SAH.~   "
14092|NCT02872025|"~     This is a pilot study to investigate the change in the immune microenvironment of high risk~     ductal carcinoma in situ (DCIS) after short term exposure to pembrolizumab.~   "
14093|NCT02870972|"~     This 2-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in~     preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the~     study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.~     Assuming successful completion of Part 1, additional subjects will be randomized in Part 2~     to one of 2 lower doses of BCX7353 or placebo. The study will compare the number of acute~     attacks in each treatment group, as well as a number of other clinical and pharmacologic~     outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.~   "
14094|NCT02870140|"~     The primary objective of this study is to compare the performance of SUPRAFLEX to that of~     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The~     patients will be followed through 3 years for major clinical events.~   "
14095|NCT02870127|"~     The existence of a family factor in the genesis of varicose veins is certain, but few~     studies have addressed reliably instead of the genetic factor in clinical and molecular~     level. The investigator initiated an original study to identify one or more genetic~     abnormalities predisposing to varicose disease, based on a combined approach of genetic~     linkage and of exome sequencing. The clinical research phase is an essential prerequisite to~     the identification of genetic mutations; it is to identify large affected families and~     ensure an extremely rigorous and accurate phenotyping of individuals over several~     generations. A first clinical work has identified and / or phenotype 8 families with a~     genetically informative family suggesting autosomal dominant inheritance. Linkage analysis~     suggested several candidate chromosomal regions without allowing the identification of a~     gene. This project aims to resume and expand the Family clinical investigations and apply~     the techniques of genome analysis points, including exome sequencing on the most informative~     families to identify the genes and mechanisms responsible of this disease and improve the~     prevention and the treatment of varicose veins.~   "
14096|NCT02870114|"~     The purpose of this study is to implement a national survey to collect information regarding~     Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial~     factors.~   "
14097|NCT02870101|"~     The purpose of this study is to provide data and analyses to support 510(k) applications to~     the FDA for multiple nucleic acid amplification tests (NAATs) diagnostic platforms.~   "
14098|NCT02872831|"~     The primary objective of this proposed prospective randomized, multi-center study is to~     evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to~     compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle~     aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in~     the pancreas and gastrointestinal tract. The secondary objective is to determine the ability~     of the 22G SharkCore™ needle system to yield histologic tissue.~   "
14099|NCT02872818|"~     The purpose of the study is to determine apoptotic signaling pathways such as Survivin,~     Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial~     hyperplasia after metformin and medroxyprogesterone acetate administration.~   "
14100|NCT02872805|"~     One of the distinct challenges faced by emerging adults with HIV is the transition of their~     care from their long-term pediatric HIV provider to treatment within an adult HIV program.~     The consequences of an unsuccessful transition can range from difficult to catastrophic. The~     Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a randomized trial of~     innovative interventions targeting gaps in care that are major drivers of loss in the ART~     continuum of care cascade among adolescents and increasing missed opportunities to engage~     adolescents into care. The specific aims of ADAPT are: 1. To inform strategies for~     transition services in resource-limited settings; 2. To examine the developmental, clinical,~     and other factors that predict a successful transition; and, 3. To gain fundamental insight~     on implementation barriers among African adolescents through the application of the~     ego-network defined social support that will inform targets for structured intervention.~     ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites~     supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators~     will conduct six focus groups including: Adolescent patients, parents and health care~     providers. To address aim 2, the investigators will conduct a cluster randomized clinical~     trial. The two interventions are based on prior evidence-informed engagement strategies: 1)~     educational interventions and 2) interventions that use a peer transition advocate who~     prepares the adolescent and their parents for transition. The investigators will enroll 300~     patients (150 patients in each arm). The sites will be randomized to an intervention. The~     primary outcome will be successful transition, keeping two follow-up appointments within a~     nine months period following transition. Secondary outcomes, as recommended by focus group~     participants will also be measured. To examine the potential role of social network~     components and characteristics of both egos and alters on primary outcomes, a Generalized~     Estimating Equation (GEE) approach will be used to explore the associations between primary~     outcomes and factors at the ego, alter, and network levels. The finding from this study will~     guide institution of best practices for transitioning adolescents in Nigeria and other~     countries lower and middle income countries with similar challenges and potential for high~     impact.~   "
14101|NCT02872792|"~     Cycloergometer is a validated method for different care. This kind of device allow passive~     and active care for patient. The interest of cycloergometer for patient hospitalized in~     Intensive Care Unit for Sepsis has never been demonstrated.~      The main objective of this study is to determine the impact of early mobilization by~     cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients~     with septic shock~      The secondary objectives of this study are to assess the impact of early mobilization by~     cyclo-ergometer in association with standard physiotherapy on:~        1. the duration between hemodynamic stability* and the removal of sedation~        2. the duration between the removal of sedation and ICU discharge~        3. the mechanical ventilation duration (invasive and noninvasive)~   "
14102|NCT02872779|"~     The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and~     clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA),~     circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate~     the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest~     that early evaluation could be clinically relevant. Indeed, early tumoral response seems to~     be correlated to overall survival. Moreover, post-operative morbidity increases with the~     number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy~     regimens when response appears to be insufficient.~      The aim of the present study is to evaluate, in a prospective cohort of patients treated~     with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted~     therapy as first line treatment for a mCRC, the correlation between early variations of~     circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA,~     and the 3 months objective response as defined in the RECIST 1.1 guideline.~   "
14103|NCT02872766|"~     43 Subjects (43 eyes) qualified for participation will undergo the required screening~     procedures to determine study eligibility. The surgical protocol involves applying~     riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA light~     with the KXL II system according to the programmed treatment pattern.~      All use of the KXL II system will be in accordance with the general instructions in the~     operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and~     24 months after treatment.~      Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual~     acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS),~     will be obtained at baseline and at appropriate times after the treatment.~   "
14104|NCT02872753|"~     The rational of intra-articular Platelet-rich Plasma (PRP) administration is based on both~     the biological and mechanical properties of PRP, which exerts positive effects on the~     modulation of the entire joint environment through the local release of a milieau of growth~     factors and other bioactive molecules that act on all the articular tissues, contributing to~     minimize the inflammatory distress following surgery.~      The aim of the present double blind controlled study is to evaluate the effects in terms of~     pain control and functional recovery provided by a single intra-operative injection of PRP~     performed at the end of arthroscopic partial meniscectomy.~      Patients included in this trial will be randomized in two treatment groups: the first one~     will receive a single injection of 3-5 cc of PRP (which will be produced directly in the~     operating room (OR) using a dedicated centrifuge) at the end of the arthroscopic~     meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure~     the double blinding of the trial all the patients enrolled will undergo blood harvesting~     before anesthesia, and PRP will be produced just for the patients included in PRP group.~      All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery~     by the following evaluation tools: IKDC (International Knee Documentation Committee)~     subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS~     (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the~     basal evaluation and at each follow-up visit up to 2 months, active and passive Range of~     Motion (ROM) of both the operated and contralateral knee were documented; also in addition,~     the trans-patellar circumference of both knees was registered to assess the trend of knee~     swelling over time.~      Drugs assumption during the follow-up period will be recorded for each patient. All eventual~     adverse events occurred during the follow-up period will be registered.~   "
14105|NCT02872740|"~     Title: Embolization of Gastric Arterial Supply for Weight Loss~      Sample size:~      10 patients~      Study Population: Morbidly obese patients who were seen by the bariatric surgery program at~     Toronto Western Hospital but are either not interested or not eligible for surgery.~      Study Design:~      Single center, randomized, prospective, non-blinded pilot study.~      Study Duration:~      12 months (November 2015 - December 2015).~      Agent:~      150-250 micron polyvinyl alcohol particles~      Primary objective:~      To further evaluate the safety of embolization of the left gastric and gastroepiploic~     arteries. To determine if either or both will result in significant weight loss and decrease~     in waist circumference among obese patients.~      Primary objective measure:~      The number of adverse events in a 1 year period will be recorded. The weight change from~     baseline will be recorded.~   "
14106|NCT02872727|"~     The object of this new project is to proceed with investigations with the employees of the~     cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory~     function while measuring their nanoparticle exposure. This will enable us to assess the~     possible link between exposure and respiratory function evolution in the employees~   "
14107|NCT02872714|"~     The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a~     monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma~     harboring FGF/FGFR alterations.~   "
14109|NCT02872688|"~     The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic~     bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults.~     Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is~     open-label and subjects will act as their own controls as the microbiome is unique to~     individuals. During the run-in period, subjects will collect two stool samples and complete~     daily bowel habit diaries in order to understand usual habits and profile the microbiome for~     each subject. 30 subjects will take part in this research study conducted at Nutrasource~     Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be~     collected at the end of the study and daily bowel habit diaries maintained for the duration~     of the study.~   "
14110|NCT02872675|"~     This study will investigate the effects of consuming a nutritional supplement (Bimuno®~     Galactooligosaccharide), and Placebo in a randomised order on gut bacterial composition,~     markers of inflammation/immune function, and pulmonary function in adults diagnosed with~     Exercise-Induced Asthma (EIA).~      We hypothesise that positively altering the gut bacterial composition of adults with EIA~     will lead to improvements in immune function, and subsequently pulmonary function.~   "
14111|NCT02872662|"~     This study aims to develop highly sensitive methods for early detection of relapse based on~     the patients unique mutations. Initially, a mutational screen is being performed. Primers~     directed against these mutations will be constructed and presence of mutations will be~     followed in bone marrow and blood frequently after transplantation.~   "
14112|NCT02872649|"~     Patients with severe heart failure supported by left ventricular assist device (LVAD)~     require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct~     thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term~     anticoagulation.~      In this pilot single-center study, thirty LVAD patients with stable renal function were~     scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after~     implantation of a HeartWare HVAD system following an open-label balanced parallel group~     design.~   "
14113|NCT02872623|"~     Early diagnosis of tumors of the small intestine is a challenge for clinicians and for~     radiologists. The detection of tumors of the small intestine is a field in which the video~     capsule endoscopy has the lowest performance.~      The entero-CT with enteroclysis is the imaging technique used primarily to explore patients~     with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis~     has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the~     patient and it is a complicated examination in terms of logistics with necessity of specific~     equipment to insert the nasojejunal tube.~      MRI has been proposed as an alternative imaging technique and satisfactory results have been~     reported with the MRI enteroclysis. However, this technique has several disadvantages~     related to nasojejunal tube insertion and the necessity of equipment compatible with the~     high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to~     distend the small intestine by ingestion of large quantities of a liquid, has a major and~     undisputed role in the exploration of Crohn's disease of the small bowel. However, its~     capacity for distension of the small intestine for optimal tumor detection is questioned and~     its role in tumor detection is largely unknown.~   "
14114|NCT02872610|"~     The objective of the SOS-trial is to examine if an online self-help intervention is~     effective in reducing suicidal thoughts among people at risk of suicide. The SOS-trial is a~     randomized, wait-list controlled trial with 1:1 allocation ratio. A total of 438 people with~     suicidal thoughts will be allocated to the intervention condition (N=219) or the control~     condition (N=219). The intervention condition consists of a six-week internet-based~     self-help therapy intervention. The control condition consists of a waiting list assignment~     for 32 weeks. The primary hypothesis is that the intervention is superior to the control~     condition in reducing suicidal thoughts at post-test (6 weeks). The SOS-trial is a partial~     replication of a previously conducted Dutch trial.~   "
14115|NCT02872597|"~     This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to~     standard therapy in the treatment of severe asthma attacks in children admitted to the~     Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and~     half will receive an inhaled placebo.~   "
14116|NCT02872584|"~     Free fatty acid index will be measured in patients before and 1 month after high dose~     prednisone.~   "
14117|NCT02872571|"~     The liver may not be an optimal site for islet transplantation due to obstacles by an~     instant blood-mediated inflammatory response, and low revascularization of transplanted~     islets. Therefore, intramuscular islet transplantation offers an attractive alternative,~     based on its simplicity, enabling easier access for noninvasive graft imaging and cell~     explantation.~   "
14118|NCT02872558|"~     This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis~     Media in the Emergency Department setting.~   "
14119|NCT02872545|"~     The purpose is to compare percentages of myocardial segments showing attenuation in patients~     in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or~     semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.~      The hypothesis is that the percentage of myocardial segments with attenuation is~     significantly lower when acquisitions are made in forward tilted position (biker position).~      The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to~     attenuation artifacts (anterior, apical and inferobasal regions).~   "
14120|NCT02872532|"~     This protocol is being designed to offer testicular tissue cryopreservation to male~     pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or~     facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive~     potential.~   "
14121|NCT02872519|"~     This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG~     [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients~     with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as~     18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has~     spread.~   "
14122|NCT02872506|"~     Compare the quality of life at 6 months between 2 populations of patients followed for~     terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.~   "
22651|NCT02760810|"~     This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear~     fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users~     over a 14-day period.~   "
14124|NCT02872480|"~     Healthy (non-injured) and concussed college-aged participants will complete two testing~     sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a~     progressive exercise session to establish symptom exacerbation or maximal exercise capacity.~     Individuals randomized to the control group will receive no intervention between sessions,~     while individuals randomized to the intervention group will complete 30 minutes of~     stationary bike exercise at least 3 days/week.~   "
14125|NCT02872467|"~     The purpose of this research is to study the effects of nasal oxytocin administration on~     maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with~     prenatal use of cocaine during the current pregnancy will be studied at 3-6 months~     postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice~     daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information~     collected is confidential.~   "
14126|NCT02872454|"~     Major depression is the leading cause of disability in the United States and is a major~     contributor to suicide, a leading cause of premature death. The majority of individuals with~     depression do not receive adequate pharmacologic or psychotherapeutic treatment due to~     difficulty accessing services or stopping treatment due to side effects, non-response, or~     the stigma associated with attending mental health clinic visits. Mobile health information~     technology services, such as text messaging, have the potential to provide effective~     self-management support for depression to nearly every adult in the US with depression.~     Guided self-help via text messaging has been shown to be effective for improving a range of~     health behaviors as well as symptoms of depression. However, previously studied depression~     text messaging services have not utilized the breadth of psychotherapeutic techniques shown~     to be effective for depression nor have they attempted to tailor the psychotherapeutic~     content to the individual in order to improve acceptability and outcomes. Advanced~     artificial intelligence methods (e.g., reinforcement learning) offers the capability to weed~     out ineffective messages and to target messages to individuals in order to substantially~     improve program effectiveness. This pilot study is the first step in towards developing an~     artificially intelligent text message service for depression.~      The specific aims of the study are to: 1) demonstrate the feasibility of recruiting and~     enrolling participants from the general population of US adults and delivering a~     text-messaging intervention for depression, 2) determine whether there are differences in~     the perceived helpfulness of messages derived from different psychotherapeutic treatment~     modalities, and whether these differences are moderated by participant characteristics~     (e.g., age, gender, depression symptom severity), 3) determine whether messages derived from~     different psychotherapeutic treatment modalities or their perceived helpfulness are~     associated with changes in depression symptoms, and whether these relationships are~     moderated by participant characteristics.~   "
14127|NCT02872441|"~     IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by~     inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells~     predominance, and fibrosis in involved tissues. Despite a preferential involvement of~     exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are~     usually effective in this indication, but with poor tolerance and a high risk of relapse~     after decrease or withdrawal of this treatment. In this context, identification of new~     therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD~     remains actually unknown. In previous studies, it has been shown that T follicular Helper~     (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in~     the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of~     patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B~     cell compartment. In this context, this population could have an important contribution in~     the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.~      TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This~     study is an exploratory prospective multicentric study. Thirty patients with a suspected~     diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in~     the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic~     biopsy sample, will be obtained in this study. The results obtained in patients with a~     confirmed diagnosis of IgG4-RD ( IgG4-RD group ) will be compared to results of patients~     with another diagnosis ( control group ). Main objective of the study is to show by~     confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue~     of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of~     Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory~     cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating~     biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells~     after sorting of these cells and co-culture tests with autologous naive B cells. All these~     results will be compared between the  IgG4-RD group  and the  control group . This study~     should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and~     blood biomarkers, and identify therapeutic targets in these patients.~   "
14128|NCT02872428|"~     THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was~     to determine the safety and tolerability of ascending doses of valproic acid (also known as~     Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250~     mg/kg in healthy subjects.~      ID: VPA-C-002~      The second part of the study will also be to determine the safety and tolerability of single~     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic~     shock.~   "
14129|NCT02872415|"~     Numerous experimental and clinical studies have shown that preterm neonates are particularly~     sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each~     situation causing pain or discomfort can alter their development and cause short term~     cardiovascular consequences but also have long-term neurocognitive influences. Repetitive~     procedural pain can also lead to changes in the pain sensitivity threshold therefore. The~     most common painful procedures are lancing for blood glucose testing. In adults, infants and~     term newborns, forearm blood glucose testing has been demonstrated to be less painful than~     conventional sites (heel, fingers). But data is lacking in preterm neonates.~      The primary purpose of this study is to demonstrate a significant reduction in pain response~     during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born~     up to 32 weeks gestation.~      This study is an interventional multicenter (3 centers), randomized, double bind trial with~     a cross over assignment. 60 premature neonates born between 23 to 32 weeks.~      Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose~     pricks will be included. The different sites will be randomly successively tested.~   "
14130|NCT02872402|"~     The goal of the study is to investigate the effect of a lifestyle intervention program~     (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on~     minimizing postpartum weight retention among women with recent GDM.~   "
14131|NCT02872389|"~     The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and~     desflurane at equal minimum alveolar concentrations using power spectral analysis of the~     electroencephalogram.~   "
14154|NCT02872090|"~     The aim of this interventional, randomized, double-blind, monocentric, cross-over study is~     to quantify the possible deleterious effect on the cardiac autonomic nervous system control~     of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one~     beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.~   "
14155|NCT02872077|"~     This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal~     abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General~     Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment~     for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall~     length of stay.~      This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by~     means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.~   "
14156|NCT02872064|"~     Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast~     cancer.~   "
14132|NCT02872376|"~     Anemia is the most common extraintestinal manifestation of IBD, occurring in 6 to 74 percent~     of patients. Most cases of anemia in IBD are due to iron deficiency (IDA) and to anemia of~     inflammation (AI). Although the ECCO diagnostic criteria for IDA are simple, and iron~     supplementation represents a cheap and usually effective treatment, many IBD patients with~     IDA are not properly treated. The inconsistent adherence, by many physicians, to treatment~     guidelines for IDA in IBD is often motivated by the belief that mild to moderate degrees of~     anemia may not have a significant impact on the patient's quality of life or do not~     represent the main clinical problem of the patient, that oral iron supplementation may~     adversely affect disease activity, and that parenteral iron administration may cause severe~     side effects. On this basis, we aim to perform a longitudinal, prospective, observational~     study whose main objective is the determination of the prevalence of anemia in IBD patients~     in Italy. Secondary objectives of the study are a) to investigate the pathogenesis of anemia~     in IBD, with a particular focus on the differential diagnosis between IDA and AI, and how~     disease activity, extension or behavior influence the relative frequency of IDA and AI; b)~     to verify the adherence to ECCO guidelines for the treatment of IDA in IBD (the proportion~     of patients with IDA that receive adequate iron supplementation); c) to administer dedicated~     questionnaires to the patients in order to measure the influence of anemia on fatigue and~     quality of life among IBD patients.~   "
14133|NCT02872363|"~     Breast screening is a service offered by the NHS to help detect breast cancer and~     precancerous changes early at a time when treatment is more likely to be curative. An~     effective service must reach the 'at risk' but asymptomatic population. Breast screening~     uptake in London, consistently falls below the national target and is well below the~     national average. Uptake in West London is particularly low, with boroughs in Inner North~     West London having the some of lowest uptake rates in the country.~      Routine text message reminders have proven effective at improving uptake of breast screening~     appointments. However little attention is paid to the content of the messages. Previous~     studies of text message reminders in other clinical areas have shown that the content of~     these messages matters and some text messages are more effective than others.~      This protocol describes the design of a randomized controlled trial to investigate the~     effect of differently worded text messages on the engagement with breast screening in West~     London.~      Two intervention arms were designed taking into consideration results of a 1000 woman survey~     to highlight the behavioural barriers that most predict attendance. The survey tested 15~     behavioural constructs and the two that most strongly predicted history of attendance were~     used to inform the text message content of the intervention arms for this trial.~      To this end, this randomised controlled trial (RCT) will test the current standard practice~     text message reminder against two intervention text message trial arms informed by the above~     described survey.~      The setting is West of London Breast Screening Service and women aged 47-73 who are due for~     screening will be randomized to receive one of the three trial arms.~      The primary outcome is the difference in uptake between trial arms. Further statistical~     analysis will analyse the difference in uptake by age group, deprivation score and previous~     attendance status.~      Result will inform how small changes to the word content may have significant effects on~     attendance at screening mammogram appointments.~   "
14134|NCT02872350|"~     Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in~     premature infants.~      The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to~     date is the reference examination to confirm or refute the diagnosis. Indeed, the presence~     of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the~     diagnosis. The prognostic value of these radiographic findings is currently controversial.~      Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began~     to be considered for some years. It also has other advantages, including that of not being a~     radiating examination. Studies on the prognostic value of abdominal ultrasound are rather~     few. Moreover, they involve a series of heterogeneous patients in terms of gestational age.~     Or the pathophysiology of ECUN in children born at term and in children born prematurely is~     not the same.~      The objective is to study prospectively the prognostic contribution of abdominal ultrasound~     in the ECUN in premature under 33SA.~   "
14135|NCT02872337|"~     The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical~     therapy protocol on postoperative (1) discharge disposition, (2) pain, function and~     stiffness and (3) patient satisfaction.~   "
14136|NCT02872324|"~     Mindfulness is both a natural resource of individuals present in all individuals in varying~     degrees characteristic ability of attention to the experience that unfolds moment by moment~     without judgment and a practice based on meditation, mindfulness exercises, which aims to~     enhance two central skills of mindfulness that are the presence and acceptanc. In the~     context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT~     is recognized as effective in psychological suffering and relapse. The mechanisms implied in~     MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms,~     reduction of rumination is a major factor in the action of MBCT, especially for patients~     with less than three depressive relapses.~      This exploratory research focuses on the impact of mindfulness functioning (mindfulness~     resource level at baseline) on the benefits of MBCT for patients with recurrent depressive~     disorder.~      The objective is to assess whether the level of mindfulness resource of patients with~     recurrent depression is a factor contributing to the positive effect of a MBCT applied in~     add-on to conventional care.~      This objective will be measured by comparing the clinical improvement of patients secondary~     to MBCT according to the initial categorization of the mindfulness resource.~      Clinical improvement will be more important for patients characterized by a lower initial~     level of mindfulness resource.~   "
14137|NCT02872311|"~     This is an open-label, randomized trial in up to 180 adults aged 65-74 years to evaluate the~     immune response to standard dose, high dose, and adjuvanted influenza vaccine across 2~     seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines~     and will have pre and post-vaccination serum blood draws for a total of 6 draws over 18~     months.~   "
14138|NCT02872298|"~     Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation~     (TLD) Therapy in subjects with severe, refractory asthma.~   "
14139|NCT02872285|"~     The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC~     in patients with moderate plaque-type psoriasis.~   "
14157|NCT02872051|"~     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care~     intervention and 2) an integrated mental health care and vocational rehabilitation~     intervention for people on sick leave because of depression and anxiety in Denmark~   "
14158|NCT02872038|"~     The purpose of this study is to compare the efficacy of empirical antibiotics of~     CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy~     versus combination of cefazolin and ceftazidime. Patients were randomized to be administered~     either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or~     cefazolin and ceftazidime (control group) in the same dose.~   "
14140|NCT02872272|"~     The loss of skin barrier function after burn causes increased susceptibility to infections,~     which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics~     are one part of the therapeutic arsenal available to treat these infections. Pseudomonas~     aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this~     population of patients.~      The use of dressings impregnated with amikacin is a common practice. Actually, there are no~     available data on local and systemic effects with this antibiotic. The study of tissue and~     plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this~     singular use of amikacin and improve the care of burn patients.~      The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin~     after dermal administration and impregnated dressing to estimate the pharmacokinetic~     parameters and their variability in a burned population.~      Secondary objectives are to assess on the one hand the relationship between the~     effectiveness of treatment and the concentration of antibiotic at the site of tissue~     infection, and on the other hand to assess the relationship between plasma concentration and~     the toxicity found of this treatment. We would like also to note the efficacy of the~     antibiotic treatment in terms of: need for repeat surgery (new skin graft), healing time and~     hospital length of stay.~      Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the~     start of treatment.~      The knowledge about the tissue concentrations obtained and a possible systemic absorption~     will then provide additional safety data and optimize the conditions of use of these~     dressings (dosage, frequency of administration) for effective treatment and safe.~   "
14141|NCT02872259|"~     The purpose of the study is to assess the safety and efficacy of BGB324 given together with~     standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard~     treatment alone,~   "
14142|NCT02872246|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
14143|NCT02872233|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
14144|NCT02872220|"~     The primary objective of this tudy was to evaluate the potential of photoallergy of of sun~     care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104~     application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed~     by irradiation with UV A and UVB.~      The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002,~     and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse~     events (AEs) throughout the study.~   "
14145|NCT02872207|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist.~   "
14146|NCT02872194|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist. The study design was a three cell, single~     blind study. Subjects were given the industry standard shampoo mixture in one eye and an~     exploratory sunscreen in the other as according to the randomization schedule.~   "
14147|NCT02872181|"~     During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to~     reduce compression of the major blood vessels by the uterus. Despite this common practice,~     there is no conclusive evidence to support this practice. In fact it may even be deleterious~     to have women positioned in this position. The aim of the study is to determine whether or~     not tilting women to the left during cesarean section (CS) is helpful or detrimental. The~     authors hypothesize that left uterine displacement of 15 degrees, which is commonly~     employed, is useless for preventing compression of these blood vessels. To investigate this~     question, women will be randomly assigned to either be tilted 15 degrees to the left during~     CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use,~     patient satisfaction, maternal complications, and fetal complications will all be collected~     and compared.~   "
14148|NCT02872168|"~     Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC,~     France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound~     of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or~     bioconversion. The biological properties of pyridinium furosemide are currently under~     investigation. Furosemide is a diuretics currently used in the treatment of patients with~     heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of~     patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of~     furosemide in humans. This study will contribute to assess the fate of pharmaceutical~     residues of furosemide in the environment.~   "
14149|NCT02872155|"~     This study evaluates if oral hydratation is as effective as endovenous hydratation in the~     prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under~     study conducting contrasted computed tomography.~   "
14150|NCT02872142|"~     This is a pilot, phase IIa, prospective, open-label, single-arm study to evaluate disease~     progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE)~     using Albutein® 5% in subjects with amyotrophic lateral sclerosis (ALS).~   "
14151|NCT02872129|"~     A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in~     western Sweden.~      The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming~     to investigate the effect of pool exercise and patient education.~      The primary aim of the present study is to examine the change of symptoms after 11-12 years~     in 166 women with FM or CWP and also investigate predictors of change of symptoms and work~     ability.~      The 166 women will be asked to participate in the present follow-up study. The follow-up~     examination comprises a standardised interview of symptoms and demographic variables, a~     battery of self-administered questionnaires and tests of physical function.~   "
14152|NCT02872116|"~     The main purpose of this study is to compare how long patients with gastric or~     gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab~     and chemotherapy compared with patients receiving chemotherapy alone.~   "
14153|NCT02872103|"~     This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the~     efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy~     treatment.~   "
14159|NCT02871999|"~     Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of~     gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or~     cell biology. Patients are randomized into 2 groups: The control group receive normal~     treatment only, the experimental group receive acupuncture therapy besides normal treatment.~     Clinical evaluation is based on the observation of the pain degree and life quality~     improvement. Blood biochemistry tests mainly include Prostaglandin~     E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide~     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis~     factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum~     cortisol, estradiol (female), progesterone (female), testosterone (male) etc.~   "
14160|NCT02871986|"~     The investigators wish to explore the variability of uterine, breast and bone outcome~     markers as surrogates to assess the adequacy of exogenous oestrogen replacement in~     individuals with hypogonadism.~   "
14161|NCT02871973|"~     The objective of this research is to conduct a small randomized pilot study to evaluate the~     feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary~     care setting to enhance parent-child interactions and explore potential impacts on parenting~     behaviors.~   "
14162|NCT02871960|"~     The purpose of this study is to evaluate surgical stress and immune function after robotic~     versus laparoscopic colectomy.~   "
14163|NCT02871947|"~     Severe asthma is a heterogeneous disease characterized by the need for treatment with high~     doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it~     accounts for a significant percentage of the consumption of health care resources. Severe~     asthma comprises various clinical and pathophysiological phenotypes. In this current study,~     we aimed to clinical characteristics and cytokes profile in severe asthma patients.~   "
14164|NCT02871934|"~     This study will determine whether using a genetic test (for the SLCO1B1 gene) can help~     patients and providers choose the right type and dose of cholesterol-lowering statin~     medications to lower the risk of cardiovascular disease, while minimizing the muscle pain~     side effects that sometimes occur with statins.~   "
14165|NCT02871921|"~     In the proposed project, we will provide 30 minutes face-to-face communications with~     interviewers through internet/webcam 4 times per week for 24 weeks, followed by sustaining~     dose of 2 times per week of 30 minutes session for additional 24 weeks (Experimental Group).~     The Control Group will receive once per week phone call which lasts less than 5 minutes~     where interviewers ask brief questions to monitor their social activities and any changes in~     health conditions. The primary outcomes are pre-post changes in cognitive test scores and~     exploratory outcomes are structural and functional pre-post changes in specific brain~     regions measured by MRI and resting state fMRI.~      This is a multi-site study where study participants will be recruited at OHSU and University~     of Michigan (UM). Study recruitment, interview (prevention trial), data entry, and MRI~     assessment will be conducted at both sites.~   "
14166|NCT02871908|"~     The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938~     administration for the prevention of diarrhea and AAD in children.~   "
14167|NCT02871895|"~     In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of~     severe sepsis and septic shock, as well as strategies for bedside implementation. The~     treatment recommendations were organized in two bundles. In an international study,~     enrolling adult patients with severe sepsis admitted to these intensive care units,~     investigators found that while mortality from severe sepsis is high (44.5%), compliance with~     resuscitation and management bundles is generally poor in much of Asia. Investigators need~     to identify the patients at risk for high in-hospital mortality in order to take appropriate~     steps.~      From their past studies, investigators found that sepsis involved inflammation and~     coagulation. The multiple organ involvement was associated with interaction of novel~     biomarkers such as cytokines. There is limited data regarding comparing and application of~     biomarkers of different characteristic on sepsis treatment. A simultaneous detection of~     multiple cytokines may provide significant prognostic information. For other biomarkers,~     promising observation data have been put forward, but their potential needs to be evaluated~     in large-scale, well-designed prospective intervention studies before clinical use can be~     recommended. Besides many clinical studies on biomarkers were confounded by its lack of~     standard bundle care for severe sepsis patient.~      Here investigators performed a systematic study aimed at evaluating~        1. the individual and combined diagnostic accuracy of biomarkers for predicting mortality;~        2. whether trend change in biomarker level more useful for above prediction;~        3. which biomarker or biomarker combination checked can predict patients at risk of~          evolving with severe organ dysfunctions.~   "
14168|NCT02871882|"~     To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,~     postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum~     FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on~     therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in~     combination with metformin.~   "
14169|NCT02871869|"~     Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma~     (NHL), has great heterogeneity in clinical manifestations, histological morphology and~     prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin +~     Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as~     the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with~     DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to~     initial and secondary drug tolerance. This study aimed to explore whether Cinobufacini~     Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in~     close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates~     of adverse reactions induced by Cinobufacini Tablets during treatment.~   "
14170|NCT02871856|"~     People who may be at increased risk of lung cancer due to age and smoking history will be~     invited to participate in this international study to determine the best way of using~     computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show~     that CT screening (screening tests can find diseases early, when they're easier to treat)~     can reduce deaths from lung cancer and this study will help determine who is most likely~     benefit from screening.~   "
14171|NCT02871843|"~     This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By~     add-on what is meant is that the experimental intravenous therapy, RRx-001, is combined or~     added on to standard of care. In newly diagnosed GBM standard of care consists of~     radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by~     maintenance TMZ given until the tumor progresses or worsens. By maintenance therapy what~     is meant is that TMZ is given less frequently to prolong or extend the time during which the~     tumor remains stable.~      G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation,~     Part A) patients will be entered or assigned sequentially (that is consecutively) to~     gradually escalating or increasing doses of RRx-001 after patients have been entered on the~     previous dose until such time as it is no longer tolerated. At each dose level, a separate~     cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be~     administered by intravenous infusion (in other words, by slow injection in the veins) over~     30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved~     chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.~      In the second part of this study (Part B), new groups or cohorts of patients will receive~     RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once~     weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will~     receive increasing doses of RRx-001 and temozolomide (in other words, a double dose~     escalation) to establish an acceptable safety and activity window, in other words, a dose~     range that is relatively free of toxicity as well as active against the tumor, although the~     primary purpose of this study is to assess or evaluate safety.~      The reason or rationale to add on RRx-001 to radiotherapy and TMZ, which is described in~     more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a~     chemosensitizer, which means that experimentally it increases the activity of radiation and~     chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have~     experienced minimal toxicity or side effects with RRx-001 alone and also in combination with~     radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well~     with radiotherapy and TMZ in GBM without adding toxicity~   "
14172|NCT02871830|"~     Children and young people are recommended to undertake at least 60 minutes of moderate to~     vigorous intensity physical activity each day. However recent findings have indicated that~     only 51% of children aged 7 years were meeting these guidelines. Previous research has also~     highlighted girls are significantly less active than. Furthermore, children living in~     Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here~     reaching the recommended ≥ 60 minutes a day. The development of interventions which can~     successfully increase levels of physical activity in adolescent girls in Northern Ireland is~     of key importance. The aim of this intervention is to investigate whether or not girls (aged~     11-13 years) can increase their daily levels of physical activity over a 12 week period by~     taking part in a school-based brisk walking intervention. The impact of participating in a~     school-based brisk walking intervention on a range of other outcome measures will also be~     investigated. A total sample of 200 adolescent females will be recruited onto the study,~     with recruitment of participants taking place at the school level. Following written consent~     from parents/guardians and assent from participants, participants will be randomised at the~     school level to either participate in the walking intervention or to act as controls.~     Objective physical activity will be assessed at 3 time points using an Actigraph~     accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months~     post-intervention) participants will also undergo measurements of height, weight, waist and~     hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also~     complete questionnaires assessing levels of physical activity and a number of psychosocial~     variables at each time point. Following completion of follow up measurements, a sub-sample~     of participants (n=45) will be invited to take part in focus groups to evaluate their~     experiences of the intervention.~   "
14173|NCT02871817|"~     The CLEAR study is testing the level of agreement between in office visual acuity and Amsler~     grid testing using a mobile vision testing application, Paxos Checkup Study and standard in~     office methods. In addition the percent of patients able to successfully complete home~     testing on the digital device will be assessed.~   "
14174|NCT02871804|"~     Eligible patients will be centrally randomized to either Arm A (resection of the splenic~     vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein~     together with the pancreas).~   "
14175|NCT02871791|"~     This research study is studying a combination of targeted therapy and hormonal therapy as a~     possible treatment for breast cancer that has spread to other places in the body and is~     hormone receptor positive (HR+) and HER2-negative.~      The names of the study interventions involved in this study are:~        -  Palbociclib~        -  Everolimus~        -  Exemestane~   "
14176|NCT02871778|"~     To evaluate the safety and efficacy of treatment with VX-371, and the effect of VX-371 on~     quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).~   "
14177|NCT02871765|"~     The objective of this study is to evaluate an educational program for Atrial Fibrillation~     patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life~     distresses and quality of life.~   "
14178|NCT02871752|"~     We propose to examine the efficacy of couples-based mindfulness-based stress reduction~     (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS~     adherence, with a sample of men on AS and their spouses.~   "
14179|NCT02871739|"~     The Health Decision Sciences Center (HDSC) staff has deployed different approaches to~     training clinicians to engage patients in shared decision making for common medical tests~     and treatments. The purpose of the study is to compare the effectiveness of shared decision~     making (SDM) skills training courses using standardized patient interactions (SPI) and~     written evaluations.~   "
14180|NCT02871726|"~     The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound~     (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially~     clustered, rather than uniformly distributed, and do not accurately follow the recommended,~     sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping~     of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or~     target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are~     poorly targeted and their spatial mapping remains subjective.~   "
14181|NCT02871713|"~     Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her~     baby and may contribute to developing long term pain and disability. Women having a CD~     receive pain medication (morphine) as part of their spinal anesthetic to help with pain~     relief after surgery. Morphine works well however has several side effects such as nausea,~     vomiting and itching which may be severe enough to make it difficult to care for herself and~     her new baby. In some cases, morphine causes difficulty in passing urine within first~     24-hours of the CD requiring catheterization and thus restricting mobilization. The~     quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution~     to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to~     provide effective pain control without the side-effects associated with the spinal morphine.~     This study is to determine if women receiving QLB have as good pain control with fewer side~     effects than those who do receive the spinal morphine. Adequate pain control will be~     assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect~     profile of the two techniques, quality of recovery and long term impact will also be~     compared during this study.~   "
14196|NCT02871518|"~     This is a Phase II trial to study the effectiveness of two cycles versus three cycles of~     Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced~     Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.~   "
14197|NCT02871505|"~     The investigators compare the treatment results and clicical presentations of different~     Molecular subtyping of Treponema pallidum~   "
14182|NCT02871700|"~     The specific aims of this study will be to:~        1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy~          (MT) versus a control intervention on motor and functional outcomes of stroke patients.~        2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and~          control intervention by using magnetoencephalography (MEG).~        3. determine the correlations between neural activation changes and clinical outcomes~          after AOT and MT.~        4. identify who are the potential good responders to AOT and MT.~   "
14183|NCT02871687|"~     The purpose of this research protocol is to determine if the same effects are observed in~     vivo in humans through a randomized controlled study. Data regarding a novel mechanism of~     the widely used statin class of medications on the mineralocorticoid pathway would likely~     have significant clinical implications on the future management of hypertension and other~     cardiovascular disease given the known pleiotropy of aldosterone action.~   "
14184|NCT02871674|"~     The study aims to implement and evaluate an RCT of behavioural sleep interventions for~     children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to~     address the following questions:~        1. To what extent can a behavioural intervention improve sleep difficulties and increase~          sleep duration in children with ADHD?~        2. To what extent do intervention-induced changes in sleep for children or primary~          caregivers (women) account for any changes in ADHD symptoms?~   "
14185|NCT02871661|"~     INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a~     negative impact over quality of life in women with this diagnose. The existing treatments,~     however, are manifold but insufficient. This study aims to verify the effectiveness of~     kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia.~     METHODS: A single-blind randomized controlled trial will examine 58 women, divided into~     three treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline),~     amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline~     hydrochloride associated with electrotherapy (interferential current). Exclusion criteria~     are: presence of infections or genital cancers, chronic degenerative diseases; younger than~     18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic~     floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride~     and being pacemakers use. The parameters analyzed before and after treatment will be: muscle~     volume of the anus elevator and perfusion of the pudendal artery obtained with 3D~     ultrasound, subjective pain in vaginal intercourse (visual analog scale), monthly frequency~     of vaginal intercourse, pain referred within vulvar touch on physical examination (swab test~     from zero to 10) and female sexual function (Female Sexual Function questionnaire - FSFI).~     There will be a follow up of subjective pain in vaginal intercourse and monthly frequency of~     vaginal intercourse obtained by telephone contact with the voluntary on one, six and twelve~     months after the end of interventions. The data will be analyzed using Chi-square test of~     Pearson, Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared~     using the Wilcoxon test (related samples) and McNemar (effect of the intervention),~     considering statistical significance level of 5%. The software used is the statistical~     analysis software (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003~     and Statistical Package for the Social Sciences (SPSS) -Release 17.0.~   "
14186|NCT02871648|"~     The purpose of this research protocol is to determine if the same effects are observed in~     vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona~     glomerulosa cells to regulate aldosterone production in a short feedback loop would provide~     important insight into hormone regulation, and explain variability in pathophysiologic~     states such as hypertension and cardiovascular diseases.~   "
14187|NCT02871635|"~     Primary Objective:~      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with~     EU-approved Humira® in patients with active Crohn's disease (CD).~      Secondary Objectives:~      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501~     with EU-approved Humira® across the induction and maintenance phases.~   "
14188|NCT02871622|"~     Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35~     International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical~     practice and will be followed for 2 years for data collection. Major adverse cardiac events~     (MACE) results at 9 months will be compared to the results obtained from the BioMatrix~     FlexTM arm of the LEADERS trial.~   "
14189|NCT02871609|"~     This study is performed to analyze various aspects of biofilms on ureteral stents in a~     longterm setting.~   "
14190|NCT02871596|"~     The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol~     blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal~     microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace~     analysis) and fecal microbiota composition (assessed by next generation sequencing).~   "
14191|NCT02871583|"~     The aim of the present prospective controlled study is to compare the trunk muscle strength,~     quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.~   "
14192|NCT02871570|"~     The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK~     and safety.~   "
14193|NCT02871557|"~     This was a prospective multicenter cohort study of elderly people admitted to the acute care~     for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse~     outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women~     (61%).~   "
14194|NCT02871544|"~     Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination~     with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with~     sepsis.~   "
14195|NCT02871531|"~     Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy~     (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and~     patient quality of life in patients with extended criteria.~      Methods: A prospective, randomized, controlled trial will be conducted with 178 patients~     presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion~     criteria include: a single or multiple retinal tears in detached retina between 7 and 5~     o'clock being of any size and any distance apart from each other, including giant retinal~     tears with inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where~     suspected tear is between 7 and 5 o'clock, retinoschisis with RD if tears are located~     between 7 and 5 o'clock, mild proliferative vitreoretinopathy, none or mild vitreous~     hemorrhage. Patients will be excluded if there is a small retinal tear or multiple tears~     less than 30o apart between 8 and 4 o'clock in detached retina, retinal tear in detached~     retina between 5 and 7 o'clock, <18 years old, inability to read English, mental incapacity,~     previous history of RD, scleral buckle or vitrectomy in index eye, inability to maintain~     appropriate head posture at post-operative period and inability to visualize peripheral~     retinal due to media opacity. Patients will be randomly allocated into two groups: PnR +~     cryotherapy/laser or vitrectomy + cryotherapy/laser and the intervention will take place~     within 24 hours and 72 hours for attached and detached macula status, respectively. Patients~     will undergo a complete ophthalmological examination, including visual acuity and fundus~     assessment at baseline and at 3, 6 and 12 months after surgery. Visual acuity will also be~     measured at 1, 7 and 30 days after surgery. Global health related quality of life will be~     evaluated with the SF-36v2 questionnaire at baseline, 1 month, 1 and 2 years after~     intervention, while the VFG25 questionnaire will be applied at 3, 6, 12 and 24 months after~     surgery to measure vision related quality of life.~   "
14198|NCT02871492|"~     Randomized, double-blind, multi-center, three arm parallel group, comparative trial to~     assess pritelivir ointment safety and efficacy, ie, proportion of subjects with~     non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison~     with placebo or Zovirax® Cream. The start of treatment with trial medication will be~     initiated by the subject within one hour of noticing the first sign or symptom (eg,~     prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the~     affected area 5 times daily for 4 days.~      After self-initiation of treatment with trial medication subjects will be assessed daily by~     the Investigator until complete healing for a maximum of 13 days.~      Subjects will document application of trial medication and the status of their lesion in a~     diary. There will also be blood sampling, ECG measurement and physical examination performed~     at the investigational site.~   "
14199|NCT02871479|"~     This trial will be a single-blind, randomized, placebo-controlled, safety, tolerability and~     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment~     regimen when administered daily for up to 28 days to patients at least 17 years of age, with~     atopic dermatitis.~   "
14200|NCT02871466|"~     stem cells therapy may be a choice therapy for advanced heart failure patients refractory to~     medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous~     history of myocardial infarction and coronary artery revascularization. These patients,~     without indication to receive a cardiac resynchronization therapy (CRT), may have a~     worsening of heart failure, and symptoms of coronary artery disease. In this study we have~     evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class,~     hospitalization rate, echocardiographic left ventricle functionality, and associated to~     reduction of angina after a treatment with stem cells intra thoracic infusion.~   "
14201|NCT02871453|"~     The investigators design a randomized, control study to evaluate the therapeutic effect of~     scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients~     using the following outcomes: motor function, activity of daily living,quality of life.~   "
14202|NCT02871440|"~     Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is~     being developed by Allergan. It is desirable to understand the effect that this new emulsion~     has on tear film evaporation and tear lipid profile via interferometry, in patients with~     evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate~     the retention time of the lipid components of the new emulsion via tear collection and~     analysis in EDE and non-EDE patients~   "
14203|NCT02871427|"~     This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the~     treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior~     Disorder (RBD) in subjects with Lewy body dementia (LBD).~   "
14204|NCT02871414|"~     The purpose of the project is to improve the sleep quality and sleep duration of post 9/11~     veterans seeking college degrees. Preliminary research findings within CSU's New Start for~     Student Veterans program indicate veterans with service-related injuries report difficulties~     with sleep quality and duration. The REST program will recruit 24 college veterans and~     engage them in a seven-week multi component sleep improvement program using evidence-based~     educational and behavioral change supports that are considered best practice for improving~     sleep quality. The investigators' scientific objectives in this application are to establish~     the efficacy of a group-based sleep education and sleep-skills intervention to improve sleep~     quality and duration, and to advance understanding of relationships between participants'~     sleep-related knowledge and behaviors associated with improved sleep quality and duration in~     veterans with service-related injuries in college. The investigators will initially engage 8~     participants to establish treatment fidelity and participant satisfaction of the 7-week~     group intervention. This will be followed by engaging 16 additional participants in the~     7-week group intervention, 8 will be randomly placed as wait-list controls and then receive~     the intervention. The 7-week group intervention will take place within the CSU Occupational~     Therapy Department, and all assessments will be completed using a web-based survey.~   "
14205|NCT02871401|"~     The investigators will conduct a single-center, prospective, randomized, placebo-controlled,~     double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary~     fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of~     current or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization~     will be to pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will~     be enrolled and randomized to treatment with pirfenidone plus valganciclovir (20 subjects)~     or pirfenidone plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety~     and tolerability will be determined by type, frequency and duration of adverse events (AEs)~     and serious adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects~     will be offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon~     completion of treatment (12 weeks). Subjects will then be followed up at routine clinic~     visits at 6, 9 and 12 months for data collection.~   "
14206|NCT02871388|"~     The objective of this protocol is to adapt and pilot test an existing lifestyle modification~     intervention for weight loss for women with overweight or obesity who have had a recent~     false positive mammography screen. The purpose of this pilot trial is to establish~     feasibility of CONECT to promote weight loss through increased physical activity and diet~     change.~   "
14207|NCT02871375|"~     The purpose of this study is to evaluate DAILIES TOTAL1 ® Multifocal (DTl MF) contact lenses~     in current multifocal contact lens wearers with symptoms of end of day discomfort compared~     to their habitual multifocal contact lens correction.~   "
14208|NCT02871362|"~     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-118 on the~     systolic and diastolic blood pressure (BP) and to explore the effects on parameters of lipid~     metabolism in subjects with elevated BP and low density lipoprotein cholesterol (LDL-C)~     levels in a pilot study.~   "
14209|NCT02871349|"~     The purpose of this study is to find out how the brain of people with autism is affected by~     Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA~     approved for the treatment of heart conditions such as blood pressure~      This research is being done because there are currently no drug treatment options for~     language impairments and social difficulties often experienced by people with autism.~   "
14211|NCT02871323|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug, MEDI4736 (Durvalumab), is in patients with myelofibrosis (MF). The~     study drug belongs to a group of drugs called immune checkpoint inhibitors, which have shown~     promise in other forms of cancer, such as melanoma and lung cancer. One of the effects that~     this drug has is to activate the patient's own natural immune system. The purpose of this~     study is to examine the safety and tolerability of the study drug, to study how effective it~     is at treating patients with myelofibrosis, and to explore how certain markers in the~     patient's blood and/or bone marrow may be affected by the study drug.~   "
14212|NCT02871310|"~     The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive~     effects in healthy subjects.~   "
14213|NCT02871297|"~     Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent~     patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)~     diagnosis of MDD~   "
14214|NCT02871284|"~     Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy~     negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is~     frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins~     including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide,~     lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe~     and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options~     or preventive measures are lacking.~      There is evidence that physical activity strategies are able to address existing CIPN~     symptoms and potentially increase quality of life in affected patients. CIPN symptoms~     involves restrictions of sensory and sometimes motor modalities, for example, deficits in~     plantar perception and dysfunction of postural control and one study in type II diabetes~     patients also suggested that structured exercise might have a preventive potential with~     regard to peripheral neuropathy incidence.~      Based on these findings, we aim to investigate the preventive potential of a sensorimotor~     intervention vs. machine-based resistance training vs. usual care (wait-list control group)~     in a randomized controlled three-arm intervention trial among cancer patients undergoing~     chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to~     include 82 patients per intervention arm resulting in a total patients number to be enrolled~     of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and~     electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via~     questionnaires (EORTC QLQ-CIPN20 & FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the~     effectiveness of the selected interventions will be objectively evaluated by spectral~     analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are:~     physical performance, sleep quality and chemotherapy compliance.~   "
14215|NCT02871271|"~     The purpose of this study is to evaluate the tolerability and benefit of IQP-AS-121 on~     reducing fatigue and tiredness and to improve mental alertness.~   "
14216|NCT02871258|"~     To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of~     atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open~     label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who~     qualify for enrollment in the study will receive therapy with The MetaNeb® System following~     the labeled instructions for the device. Details of the treatment including duration and~     frequency will be defined in treatment procedures.~   "
14217|NCT02871245|"~     Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle~     section of the rectum will be as the research object. Cancer patients are diagnosed based on~     pathology or cell biology. The trial is randomized, parallel and open. They are randomized~     into 2 groups: both groups receive surgery. The experimental group receives conventional~     treatment combine with electroacupuncture Zusanli point .etc finish operation and the~     contrast receives the same conventional treatment with experimental group. Clinical~     evaluation includes gastrointestinal tract recovery of function, pain relief, life quality~     improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone,~     peroxidatic reaction and the ratio of immune cells.~   "
14218|NCT02871232|"~     To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if~     the REMS meets its surveillance goals, and if it does not, to modify it appropriately based~     on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for~     trends before and after the shared REMS is implemented to collectively assess for changes in~     abuse, misuse, overdose, addiction, and death for different risk groups and settings.~   "
14219|NCT02871219|"~     The goal of this clinical research study is to learn if combining obinutuzumab and~     lenalidomide can help to control previously untreated FL.~   "
14220|NCT02871206|"~     This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine~     (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in~     Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine~     whether the AV vaccine, can provide increased community-wide protection.~   "
14221|NCT02871193|"~     The procedures of thoracotomy are among the most painful operations. In addition to~     post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative~     discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient~     and prevent postoperative complications such as pneumonia, atelectasis, or respiratory~     failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard~     technique for providing analgesia after a thoracotomy. However, TEA carries side-effects~     such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory~     depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an~     alternative technique for TEA that may offer a comparable analgesic effect and a better side~     -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as~     single injection, they can provide analgesia for limited period. Various adjuvants have been~     tried in the past in order to enhance the duration and quality of postoperative analgesia.~     Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of~     local anesthetic block. The mechanism of its action is blocking the nociceptive impulse~     transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have~     been shown to provide superior analgesia and greater patient satisfaction compared with~     intermittent administration. System of wire-less PCA provides remote monitoring, information~     management and PCA devices with high precision. The purpose of this research is to determine~     whether dexamethasone might prolong the duration of analgesia and improve the short-time~     outcomes when administered for TPVB along with local anesthetic agents in elective~     thoracotomy.~   "
14292|NCT02870231|"~     This trial is conducted in the United States of America. The aim of this trial is to~     investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD~     (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in~     Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity~   "
14222|NCT02871180|"~     Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated~     in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h~     periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10~     p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a~     confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day.~     Secondary endpoint was the blood glucose profile during this period.~   "
14223|NCT02871167|"~     The aim of the study is to perform a French multicenter prospective interventional study in~     order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo~     cryopreservation in young women with breast cancer. The oncologic and reproductive benefit /~     risk ratio will be investigated in the oncology and reproductive area.~   "
14224|NCT02871154|"~     Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more~     than 39 hours after hCG injection may be of benefit.~      We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for~     intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from~     hCG to OPU.~   "
14225|NCT02871141|"~     The project aims to investigate markers of neural activity and connectivity, neurochemistry,~     hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity~     underlying treatment response and remission after ECT. These measures will be assessed in~     depressive patients prior, during and after ECT and also after 6 months. Furthermore, we~     will investigate a control group of depressive patients treated with antidepressants.~   "
14226|NCT02871128|"~     Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial.~     Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day~     for a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other~     group (n = 20) is a commercial iron supplement. We assess whether Natureheme-iron can~     promote iron absorption and antioxidant effects, and compare the effects with commercial~     iron supplement. When this study is completed, it will increase the value of~     Natureheme-iron, and can improve health of Taiwanese.~   "
14227|NCT02871115|"~     The purpose of this research study is to address the challenge of medication management for~     older patients undergoing treatment for cancer. The sponsor of this protocol is the~     Massachusetts General Hospital Cancer Center who is providing funding for this research~     study.~   "
14228|NCT02871102|"~     Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for~     which the current standard treatment is supportive care and avoidance of complications with~     lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a~     means of lung protective ventilation, but the mechanism for its effectiveness is not yet~     clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP).~     Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible~     means to minimize ventilator-induced lung injury. This protocol aims to identify the range~     of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure~     and the stress index, a tool to recognize potential lung hyperinflation during mechanical~     ventilation.~   "
14229|NCT02871089|"~     The purpose of the study is to use a novel treatment approach, the artificial pancreas,~     after diagnosis of type 1 diabetes (T1D) to improve glucose control with the anticipated~     improvements of residual C-peptide secretion.~      This is an open-label, multicentre, single-period, randomised, parallel group design study.~     It is expected that a total of up to 190 subjects (aiming for 96 randomised subjects) will~     be recruited within ten working days of diagnosis of type 1 diabetes through paediatric~     diabetes centres in the UK. Half of the participants aged 10 to 17.9 years will be treated~     by conventional insulin injections and the other half by the artificial pancreas (closed~     loop insulin delivery system). Each treatment will last 24 months.~      Subjects in the intervention group will receive additional training on components of the~     artificial pancreas, i.e. insulin pump and continuous glucose monitoring (CGM), prior to~     starting closed loop insulin delivery. Subjects in the control intervention group will~     continue with standard therapy, i.e. multiple daily injection therapy. The study includes up~     to 14 visits and 1 telephone/email contact for subjects completing the study. After run-in~     and randomisation, visits will be conducted every 3 months in both arms. Beta-cell function~     will be assessed by serial measurement of C-peptide in response to a standardised mixed meal~     tolerance test (MMTT). MMTTs will be conducted at baseline, 6-,12- and 24 months post~     diagnosis.~      The primary outcome is the between group difference in the area under the stimulated~     C-peptide curve (AUC) of the MMTT at 12 month post diagnosis. Secondary outcomes include~     between group differences in stimulated C-peptide AUC over 24 months, differences in~     glycaemic control as assessed by HbA1c, time spent in glucose target range, glucose~     variability, hypo- and hyperglycaemia as recorded by periodically applied CGM, as well as~     insulin requirements and change in bodyweight. Additionally, cognitive, emotional and~     behavioural characteristics of participating subjects and parents will be assessed, and a~     cost utility analysis on the benefits of closed loop insulin delivery will be performed.~     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes,~     diabetic ketoacidosis (DKA) and number, nature and severity of other adverse events.~   "
14230|NCT02871076|"~     The objective of this study is to determine if acupuncture is an effective treatment option~     for treating combat Veterans with PTSD.~   "
14231|NCT02871063|"~     The purpose of this piece of research is to assess the effect of altitude on the clinical~     evolution of ARDS. For this purpose, patients who live and receive care at sea level are~     compared with those who live and receive care at high altitudes. For reasons of convenience,~     a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be~     sought to assess whether adjusting the cut-points for the severity categories of ARDS~     improves the ability to predict some adverse events, by comparison with unadjusted~     cut-points. The results of this research will probably be disruptive, and will provide the~     first information yet about the effect of altitude on ARDS; they will therefore be of great~     interest for the international scientific community and for the direct care of patients. A~     high bibliometric impact is to be expected.~   "
14232|NCT02871050|"~     The purpose of this study is to create a biobank, which collects, stores, and distributes~     samples of human tissues, blood, and related health information to qualified scientists, in~     order to help doctors and researchers better understand why Castleman Disease occurs and~     develop ways to better treat and prevent it.~   "
14233|NCT02871037|"~     The current study is the first clinical trial proposed with PF-05221304. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     single and repeated doses of PF-05221304 to healthy adult subjects. The study may also~     evaluate effect of food on PK of PF-05221304.~   "
14365|NCT02869230|"~     Here were present a controlled clinical trial comparing wire-guided lesion localization~     (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable~     breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in~     Bogotá,Colombia.~   "
14234|NCT02871024|"~     Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized~     fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of~     randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality~     of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal~     sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain~     very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin~     B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that~     removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary~     tract infection (UTI)-related severe sepsis will attenuate sepsis associated~     microcirculation failure and result in early reversal of shock and less extent of end-organ~     damage.~   "
14235|NCT02871011|"~     The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing~     solution footbath and it's effect on the clinical signs and symptoms associated with Tinea~     Pedis~   "
14236|NCT02870998|"~     This study aims to compare the impacts of two versions of a continuing education activity~     targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction;~     3) learning; 4) competence; 5) performance; 6) patient health outcomes.~   "
14237|NCT02870985|"~     The clinical investigation is a non-inferiority, multicenter, blinding evaluation,~     randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects~     will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES,~     in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment~     of coronary artery disease.~   "
14238|NCT02870946|"~     Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support~     device for cardiogenic shock (CS) patients. During ECMO support, renal replacement therapy~     (RRT) facilitate more rapid metabolic or uremic control and more effective prevention and~     management of fluid overload which happened in critical state. CS patients who are likely to~     receive ECMO support will be enrolled and randomized with a 1:1 allocation to a simultaneous~     RRT arm vs. standard care arm.~        1. The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.~        2. The patients in the standard care arm will not receive RRT when ECMO is commenced. Only~          when a patient demonstrates AKI and fulfills any one of the criteria of the~          conventional RRT indication during ECMO support or after ECMO weaning,~          conventional-indication RRT would be delivered.~      The primary outcome is all-cause 30-day mortality after ECMO is commenced~   "
14239|NCT02870933|"~     Heart Failure has several etiologies and one of them is coronary artery disease. Coronary~     artery bypass grafting (CABG) is one of revascularizations method which has been used for~     decades in coronary artery disease theraphy. However, data about coronary artery bypass~     grafting shows that post-CABG patients still have low ejection fraction. For the last~     decade, there have been a lot of studies about the using of stem cells to increase heart~     contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone~     marrow stem cells which has been proved to have higher angiogenesis potential. The stem~     cells is given during CABG by injection transepicardial and transseptal. The purpose of this~     study is to determine whether transpicardial and transseptal injection of CD 133+ bone~     marrow stem cells can improve myocardial perfusion in patient with low ejection fraction~     following CABG surgery.~   "
14240|NCT02870920|"~     The standard or usual treatment for this disease is treatment with drugs and other~     treatments that may help to make a patient better or may improve their quality of life. This~     treatment is known as best supportive care (BSC). Although patients with best supportive~     care can feel better for some months, the cancer usually continues to grow.~   "
14241|NCT02870907|"~     Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to~     histopathological risk factors of the International Retinoblastoma Staging Working Group.~   "
14242|NCT02870894|"~     Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute~     respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for~     estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW),~     often are unreliable or require invasive measurements. The purpose of the this study is to~     develop a novel approach to reliably assess extravascular lung water by electrical impedance~     tomography(EIT).~   "
14243|NCT02870868|"~     Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S.~     use breathing exercises for health purposes. The aim of this project is to examine if~     different slow breathing has different physiological and psychological effects.~   "
14244|NCT02870855|"~     Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive~     technology, many studies have considered that the cause of two-thirds of implant failure is~     the decreased endometrial receptivity. Human chorionic gonadotropin (hCG) is an early~     pre-plant signal molecule secreted by the embryo, it can promote endometrial proliferation,~     increase blood flow and promote embryonic adhesion and inhibit self-regulate apoptosis of~     trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo~     transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But~     some studies found that the intrauterine injection of HCG can not significantly improve the~     success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG~     time is too late to significantly increase the implantation rate. Would ahead of~     intrauterine injection of HCG be more effective? Thus, the patients of repeated implantation~     frozen embryo cycle according to the random principle accepted two kinds of transplants~     ways: ①intrauterine injection of HCG before blastocyst transfer; ②blastocyst transfer. Try~     to understand whether intrauterine injection of HCG can significantly improve the clinical~     pregnancy rate of blastocyst transfer in repeated implantation failure patients.~   "
14245|NCT02870842|"~     Investigators hypothesized that maintaining low fraction of inspired oxygen would be~     beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children~     undergoing general anesthesia.~   "
14351|NCT02869412|"~     This randomized pilot clinical trial studies how well a computer-based behavior change guide~     works in increasing physical activity in patients with prostate cancer who have received~     androgen deprivation therapy. A computer-based behavior change guide website may increase~     physical activity level for prostate cancer survivors and help doctors understand what~     outcomes related to becoming physically active are most important to patients with prostate~     cancer.~   "
14246|NCT02870829|"~     The proposed study will seek to evaluate the prevalence and the progression of vascular~     calcification in a cohort of maintenance hemodialysis patients in Asian population. It will~     also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of~     vascular calcification in this group of patients.~      This will be a single-center randomized, prospective and open-label interventional clinical~     trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute~     difference in coronary artery calcium (CAC) score at 18-month between control and~     intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve~     calcification, percentage of patients with regression of coronary artery calcification of at~     least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any~     cause and major adverse cardiovascular events (MACE) over the same period.~   "
14247|NCT02870816|"~     The purpose of this study is to determine whether amnion membrane grafts are more effective~     than another tissue engineered skin substitute, when used to treat diabetic foot ulcers~     (DFUs).~   "
14248|NCT02870803|"~     Around the world there is an increasing incidence of diabetes mellitus, with millions of~     people affected. In this population, diabetic macular edema (DME) is the most common cause~     of visual impairment. While the visual impairment caused by EMD is variable, its early~     treatment can improve visual acuity and quality of life. The objective of this project is to~     use the new OCT-angiography technology, which evaluates macular capillary network without~     the need of intravenous injection of contrast, to assess macular microcirculatory network in~     its response to intravitreal pharmacological treatment of EMD. The resulting qualitative~     evaluation can be helpful in understanding the pathophysiology of visual loss associated~     with DME and in determining prognosis.~   "
14249|NCT02870790|"~     A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual~     elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is~     the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of~     co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale~     study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will~     comprise mostly gay and bisexual men (GBM) but will also include small numbers of~     heterosexuals, injecting drug users, and transgender men and women. The drug will be used~     according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new~     intervention over a 12 month period, and following participants for two years on treatments,~     a reduction of about 50% in new HIV diagnoses in NSW is expected.~      The study aims to assess the incidence of HIV among PrEP study participants and measure the~     population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over~     a two-year period.~      It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the~     incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed~     PrEP and measure the effect of the rapid roll-out of PrEP on the overall number of~     notifications of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of~     PrEP use and medication adherence, and monitor behavioural risk practices among PrEP users.~      The main population group will be 3700 gay men at high risk of HIV infection. All procedures~     of this study are guided by the NSW Guidelines on PrEP.~      Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Protocol Coordinating~     Investigator: Dr. Iryna Zablotska.~   "
14250|NCT02870777|"~     Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at~     diagnosis are generally excluded from first-line allo-SCT. However, these patients may~     eventually relapse in some of cases. The purpose of this study is to establish risk~     stratification based on cytogenetics and minimal-residual-disease(MRD) analysis to determine~     whether a MRD-directed therapy for low and intermediate AML patients has positive results in~     terms of overall survival.~   "
14251|NCT02870764|"~     This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will~     assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract]~     treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina~     pectoris.~   "
14252|NCT02870751|"~     Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in~     many countries. Vaccine candidates targeting ST are in development. A human challenge model~     using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but~     not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an~     early and efficient evaluation of an ST-toxoid based vaccine.~      In this controlled human infection study the investigators will assess the safety of a~     ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in~     healthy human volunteers.~   "
14253|NCT02870738|"~     Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary~     frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the~     bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem,~     tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS~     symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in~     treatment and often years of suffering. This clinical trial will test a bladder directed~     therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT)~     to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding~     dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor~     muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and~     allow for early, more effective treatment.~   "
14254|NCT02870725|"~     Having co-occurring depression and chronic headaches is challenging and can greatly impact~     one's professional, personal, family, and social life. People living with chronic headaches~     are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety),~     reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis~     or under-treatment of both chronic conditions.~      This study is a pilot clinical trial that will compare the effectiveness of a brief~     cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group.~     The aim of the study is to determine how well the CBT intervention will reduce the~     frequency, severity and level of disability of both the headaches and depression symptoms.~      **Study will be conducted at Henry Ford Hospital - Main campus in Detroit, MI. Must already~     be, or are willing to become, a patient of the Henry Ford system to participate. Please~     contact me with any questions about this.~   "
14255|NCT02870712|"~     During childbirth, the recommendations have evolved to a restriction of episiotomy. This~     reduction results in an increase of superficial vaginal and perineal tears. These lesions~     are usually routinely sutured which often causes the onset of discomfort and pain in the~     immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin~     was not sutured perineal tears during the second degree. Others have compared different~     techniques in the same indications (separated points running suture, biological adhesive)~     without demonstrated impact. These studies were not interested in isolated perineal tears or~     first degree or the application of a simple manual compression with or without a suture~     according to the result of hemostasis.~      Our objective is to evaluate the possibility of not suture the perineum of the first degree.~     The use of suture only result of bleeding not yielding to manual compression.~      Our approach is guided by the principles of primum non nocere and discerning about the~     dogmatic systematization.~   "
14256|NCT02870699|"~     Docetaxel is widely used in oncology for the treatment of many solid tumors. The side~     effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is~     neutropenia. Skin and nail manifestations, frequency, the second category of adverse events~     after haematological adverse events.~      Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having~     nail damage.~      The purpose of this study is to confirm the effectiveness of the film-forming solution~     Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and~     treated by adjuvant docetaxel.~   "
14257|NCT02870686|"~     For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure.~     However, the risk associated radiation exposure to patients and staff are not neglible.~     Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile~     duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is~     highy accurate technique in detecting common bile duct stone and guiding for therapeutic~     intervention. There has been a few data from literature showed that EUS guided CBD stone (~     CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and~     complications. This randomized trial is designed to address the question that EUS guided~     CBDS removal is equivalent to ERCP in term of efficacy and safety.~   "
14258|NCT02870673|"~     In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral~     neuropathy and usually happened to female, mid-age population, overweight persons, and those~     who overused their hands for work or production. Some research claimed this might be~     correlated to anatomical characteristics such as the longer anteroposterior diameter or~     smaller cross section area of the wrist. Preliminary symptoms often start with sensory~     domain (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned~     above) and then progress to motor domain (thenar muscle atrophy and clumsiness) if left~     untreated.~      Depending on the severity, patient's willingness and convenience, there are many options for~     CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the~     first choice, including physiotherapies, local injection and night splints. Local steroid is~     proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the~     effects will decline gradually and repetitive injections is suggestive. The patients with~     severe symptoms which comprise thenar muscle atrophy will be advised to receive~     decompression surgery.the surgery can alleviate the illness with high success rate up to~     70%. Unfortunately, there are still patients who will relapse or undergo side effects, for~     example, finger weakness.~      In recent years, acupuncture researches focused on CTS intervention have been outgrowing and~     promising. Whereas, there are still lack of evidence which stands for the therapeutic~     effects comparing with local steroid injection. This limits the built-up of suspect~     mechanism of acupuncture intervention for CTS.~      This is a preliminary, randomized and single-blinded study which started since 2016 and last~     for a year. The investigators utilize ultrasound to guide the depth of needle penetration~     which prevents unnecessarily tissues injury such as artery or dry needle injury. This~     procedure also guarantees the needles lie directly on the upper surface of the median nerve.~     One group will receive electrical stimulation and another won't. The investigators use~     electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal~     Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and~     hand score and Jamar grip dynamometer as outcome measurements. The results gathered from two~     experimental groups will be compared with the data from the control group whose participants~     only receiving local steroid injection once in the first week. The participants are all~     above 18 years old and complain of illness for a least 3 months without any surgery or local~     injection for a least 1 year. The investigators set up strict exclusive criteria and sample~     size estimation is 70.~   "
14259|NCT02870660|"~     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder, defines as high~     cholesterol level and premature death. The prevalence of FH has been reported in few~     countries however unknown in Iran. Thus recognize the FH patients, determine the diagnostic~     strategies and appropriate treatments are important.~      Also acute coronary syndrome (ACS) is a group of conditions which arises from reduction of~     blood flow in coronary arteries. Three specific conditions are included: ST elevation~     myocardial infarction, non ST elevation myocardial infarction and unstable angina. Premature~     ACS defined by occurrence of ACS<55 for men and ACS<60 for women. Studies demonstrated~     direct connection between familial hypercholesterolemia and occurrence of premature ACS.~     Investigators intent to detection of FH amongst patients with acute coronary syndrome.~   "
14260|NCT02870647|"~     Prospective, international, non-randomized, multicentre, clinical investigation (phase IV).~     The aim of the study is to investigate the correlation between HF, severe SBD, and AF in~     CRT-P patients at 6 months.~   "
14261|NCT02870634|"~     Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study~   "
14262|NCT02870621|"~     The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when~     accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue~     samples to test this hypothesis. Renal tumor could itself be responsible for inflammation~     and fibrosis in its environment. This study aims to measure the influence of the tumor on~     his kidney Environment and fat and define molecular markers not influenced by renal tumor.~     The main objective is to compare the inflammation of the perirenal fat taken in two~     locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each~     patient as his own control. The secondary objective is to compare the degree of interstitial~     fibrosis of the renal cortex in the same sampling methods.~   "
14263|NCT02870608|"~     The objective of the study was to evaluated the feasibility and reproducibility of the~     measurement of lung elasticity report / fetal liver according to gestational age in a group~     of patients with a normal course of pregnancy and in a group of Patients at risk of preterm~     delivery.~   "
14264|NCT02870595|"~     The investigators hypothesize that patients who receive 1% lidocaine injections for digit~     blocks of the finger will experience less pain when the injection is accompanied by the use~     of a micro-vibratory stimulator (MVS) compared with patients who receive injections without~     the MVS.~   "
14265|NCT02870582|"~     The investigators do the clinical trial (patients with metastatic colorectal cancer treated~     with donafenib/placebo after failure of standard therapy) to assess efficacy and safety of~     donafenib in patients with metastatic colorectal cancer, progressing after all approved~     standard therapies.~   "
14266|NCT02870569|"~     Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).~   "
14267|NCT02870556|"~     Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in~     total laryngectomy patients. PCF significantly increases morbidity, length of~     hospitalization, and cost of care, in addition to delaying the beginning of adjuvant~     therapy. The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation~     in the primary management of laryngeal carcinoma has resulted in an increase in the PCF~     formation after salvage laryngectomy (STL).~      Previously reported risk factors for PCF development include preoperative radiotherapy,~     tumor stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and~     anemia.~      Among surgical options, the pectoralis major myofascial flap has been proposed to cover the~     pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin~     during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural~     anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is~     to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of~     pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis~     major myocutaneous flap.~   "
16001|NCT02847897|"~     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in~     patients with vulvovaginal atrophy. Eligible subjects will receive 3 treatment sessions, 4~     weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.~   "
14268|NCT02870543|"~     This study aims to evaluate, through a crossover, controlled, double-blind and randomized~     clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa~     officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years~     old with nocturnal bruxism will be randomly allocated into different groups of treatment~     stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4)~     Phytolacca decandra associated with Melissa officinalis. All children will participate to~     each clinical stage, with a period of 14 days of whashout. Children and the principal~     investigator will be masked to treatment. The efficacy will be evaluated through parents~     report about the absence of tooth clenching or grinding by children and electromiography~     exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life~     related to oral health.~   "
14269|NCT02870530|"~     The purpose of this study is to determine the efficacy of of gastric bypass without gastric~     division as a treatment for morbid obesity~   "
14270|NCT02870517|"~     The purpose of this study is to assess the effect of music, played prior to a surgical~     procedure, on stress levels during induction of anesthesia. Hypothesis: playing calming~     music, pre-selected by the investigator and the patient, beginning just prior to induction~     and terminating after induction will positively reduce the patient's heart rate, blood~     pressure, and respiratory rate during this period. For this study, noise-cancelling~     headphones with the ability to play music via an iPod will be utilized.~   "
14271|NCT02870504|"~     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a~     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an~     existing angle close or angle adhesion in order to reduce the risk of attack of the angle~     closure glaucoma. However, there are very little research on the laser site, laser~     wavelengths, laser energy and laser spot intervals. The purpose of this study is to~     determine the optimum laser site of LPI.~   "
14272|NCT02870491|"~     The purpose of this study is to assess how free distribution and preemptive home delivery of~     oral rehydration salts (ORS) by community health workers affects ORS use. The investigators~     will measure the impact of the combination of the two interventions (free distribution +~     pre-emptive home delivery) as well as the impact of each intervention separately (free~     distribution without home delivery and pre-emptive home delivery without free distribution).~   "
14273|NCT02870478|"~     The purpose of this study is to determine whether less frequent dosing of atropine drops may~     be as effective as daily dosing for the treatment of progressive myopia.~   "
14274|NCT02870465|"~     The main objective of this non-interventional, observational study is to analyze the rate~     and type of infection complications while performing closed reduction internal fixation~     (CRIF) of hand fractures in the operating room versus an ambulatory setting. The~     investigators will do so by prospectively collecting data on the type of fracture,~     handedness, co-morbidities, duration of treatment, number and type of K-wires, duration of~     fixation and complication rate. Patients presenting with hand fractures to the emergency~     room will be recruited. Patients will be recruited in multiple centres across Canada and~     managed according to the institutional standard. The complication type and rate will be~     recorded and analyzed to determine a difference of performing the procedure in the operating~     room or clinical setting.~   "
14275|NCT02870452|"~     The purpose of this study is to evaluate the relative effectiveness of two psychological~     interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and~     managing pain, regulating emotional state and improving quality of life in Portuguese PWH.~   "
14276|NCT02870439|"~     Burn injury with full-thickness skin damage that encompass large body surface areas can~     induce local and systemic perturbations that are costly in terms of human suffering as well~     as in strains on the health care system. Characterization of new major molecular biomarkers~     involved in this process creates significant diagnostic and therapeutic challenges.~      Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric~     transcription factor comprising an α and a β subunit. It was shown that under normoxic~     conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic~     conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a~     spectrum of target genes encoding multiple angiogenic growth factors and cytokines of~     potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative~     splicing have been identified.~      The importance of HIF-1α in wound healing in animal models has been suggested by several~     studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of~     impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in~     mice in case of burn wound skin that in the case of excisional cutaneous wound. Other~     studies have shown that the expression of HIF-1α was correlated with the extent and depth of~     the burns.~      This study aims to improve the knowledge on the pathophysiological factors involved in the~     field of wound healing. The assumptions are based on results of studies done on mice, and~     this work aims to document these findings in humans.~      Objective~      The main objective of the study is to compare the variations of expression of HIF-1α~     measured in blood and skin tissue samples in three groups:~        -  Subjects with major burn wounds involving more than 20% of the total body surface area;~        -  Subjects with burn wounds smaller than 5% of total body surface area;~        -  Subjects with a skin wound after a surgical procedure requiring a skin resection.~      Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site~     to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α~     target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and~     to assess the correlation between the expression of HIF-1α and the kinetics of wound healing~     of the subject rated by evaluation of time of donor sites complete epithelialization.~      Material and Methods~      We propose to create three groups:~        -  15 patients with extensive third degree burns involving more than 20% of the total body~          surface area;~        -  15 patients with less extensive third degree burns, involving less than 5% of body~          surface area;~        -  15 patients with post-surgical wounds with skin resection. Skin and tissue specimens~          will be collected three times: day 0, 7 and 14 from burned patients (with more than 20%~          of the total body surface area and less than 5% of body surface area). Samples of skin~          tissue will be collected within the skin resection from patients with post-surgical~          wounds at day 0, blood samples will be collected at day 0 and 14.~   "
14277|NCT02870426|"~     To obtain olfactory bulbs from brain stem dead patients who undergo organ donation.~      Aims:~        1. Optimisation of olfactory bulb collection and olfactory ensheathing cell culture and~          storage.~        2. Study of the effects of patient diagnosis, age, cause of death and co-morbidities on~          cell survival and regenerative function.~        3. In future studies, the olfactory ensheathing cells may be injected into patients with~          spinal cord injuries.~   "
14278|NCT02870413|"~     The investigators will conduct a randomized controlled trial (RCT) to generate data on the~     impact of direct-to-consumer telelactation (virtual breastfeeding support) services.~     Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a~     critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into~     two study arms: 1) outpatient telelactation services via video calls on personal devices or~     2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and~     satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and~     compared across groups.~   "
14279|NCT02870400|"~     The primary objective of the study is to assess the safety and tolerability of single~     ascending doses of REGN2477 in healthy women not of childbearing potential.~   "
14282|NCT02870361|"~     Insulin resistance is a central pathophysiological component of type 2 diabetes and is~     associated with a high risk of cardiovascular disease. The tissue in which it manifests are~     mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is~     independent of insulin, this organ has traditionally not been studied in this regard. In~     animal experiments, however, knockout of the insulin receptor in the brain leads to obesity~     and peripheral insulin resistance. This finding of insulin action in the brain could also be~     confirmed in human studies.~      The investiagtors intend to investigate whether central nervous insulin action affects~     insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15~     minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion.~     Insulin sensitivity of the brain is measured by a an established protocol with functional~     magnetic resonance imaging before and after nasal insulin administration.~   "
14283|NCT02870348|"~     This is a multi-center, open-label study to evaluate the long-term safety of weekly IV~     infusions of 60 mg/kg Alpha-1 MP in adult subjects with AATD in Japan who have completed~     Study GTI1401.~   "
14284|NCT02870335|"~     Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with~     other theories such as the weakness of the extensor muscles of the back or hamstring injury,~     can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To~     observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF)~     after three treatment sessions. In turn, know which of the two treatments have a greater~     benefit and longer. Methods: The population consists of grass hockey players and senior~     category aged between 16-30 years. They were randomly divided into two treatment groups.~     Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study~     duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each~     evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris~     questionnaire.~   "
14285|NCT02870322|"~     This research will use randomized controlled trial (RCT) methodology to assess the~     feasibility of a prescription for fruit/vegetable CSA shares or exercise by bikeshare on~     obesity-related outcomes. Three cohorts of n=10 University of Wisconsin-Madison (UW)~     students (total 30) will be randomized to three groups: (1) a 10-week fruit and vegetable~     community supported agriculture (CSA) share prescription program with vegetable education~     and cooking support from UW Slow Food; (2) a 10-week Madison B-cycle bikeshare membership~     prescription program with exercise support or (3) a non-interventional wait-list control~     group. The primary outcome will be change in Body Mass Index (BMI) (a measure of obesity~     using a person's weight in kilograms divided by his or her height in meters squared).~     Secondary outcomes will be fasting lipids, blood pressure, and glycated hemoglobin (HGA1c)~     levels. All of these measures will be tested at baseline and just after the 10-week~     intervention~   "
14286|NCT02870309|"~     This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of~     weekly intravenous infusions of 60 mg/kg of Alpha-1 MP for 8 weeks.~   "
14287|NCT02870296|"~     The primary study goal is to improve the quality of care transitions for patients with new~     episodes of venous thromboembolism (VTE).~      Primary Outcomes: To measure differences in the quality of care transition, as measured by~     the Care Transition Measure (CTM)-15 in the investigators target population of patients with~     incident VTE randomized to either a multicomponent, anticoagulation medical home~     intervention or usual care.~      Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage,~     all-cause re-admissions, and mortality between the investigators intervention and comparison~     groups at 30 and 90 days in the investigators target population.~      Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and~     time in the therapeutic range (TTR) for patients on warfarin in the investigators target~     population.~   "
14288|NCT02870283|"~     To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)~     mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),~     and assessment of the quality of life of these patients.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of bipolar mixed episodes.~   "
14289|NCT02870270|"~     Radiation therapy (RT) leads to a markedly reduced salivary secretion rate, which makes it~     difficult to eat and talk and it is a risk factor for oral disorders such as caries and~     mucosal infections. A reduced salivary secretion rate is often a life long side-effect of~     the treatment that seriously affect the quality of life. To reduce these side-effects the~     patients get preventive and supportive oral treatment in connection with their cancer~     treatment. However, regardless of radiation doses given, the severity of the problems vary~     considerably. Therefore, a better understanding on when and why problems occur is important~     for the identification of subjects at risk and to find better measures and treatments,~     suited for their individual needs.~      Dentate subjects were included referred before RT. Data were collected before and during~     treatment as well as 6, 12 and 24 months after completed RT. Cancer diagnosis, treatment,~     radiation doses, infections and medication were obtained from medical records.~      Dietary habits were registered using a questionnaire focusing on intake of carbohydrate-rich~     food-items and items containing sugar-substitutes. The subjects weight was registered~     before, during and after RT.~      A clinical examination was performed before and 6, 12 and 24 months after completed RT.~     Panoramic x-rays were taken as well as bitewing radiographs. The number of teeth, caries~     status, oral hygiene were registered. Mucositis was registered during RT.~      Secretion of stimulated whole saliva was determined. Minor labial and buccal gland saliva~     secretion rate was determined using the Periotron-method. Microbial samples were collected~     from the tongue, buccal mucosa and supragingival plaque and microorganisms associated with~     oral health and oral disorders analysed using cultivation technique.~      The quality of life was registered using the questionnaires EORTC QLQ-C30 (European~     Organization for Research and Treatment of Cancer Quality of Life Questionnaire). To address~     additional symptoms associated specifically with cancer in the head and neck region and its~     treatment, a complementary 35-item module, the EORTC QLQ-H&N35 was used.~      The patients also completed the Hospital Anxiety and Depression Scales, HADS, which is used~     to measure severity of anxiety and depressive symptoms and provides estimates of possible~     mood disorders in patients with somatic comorbidity.~   "
14290|NCT02870257|"~     Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will~     be recruited and randomized into two groups of treatment. The group a will receive a~     strenghtening protocol with progressive overload during 20 sessions and group b will~     receive the same protocol with minimal load, without change during the 20 sessions. The~     primary outcomes measures will be pain, function, quality of life, global impression of~     recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6~     months (follow-up). The secundary outcomes will be disability, quality of life measure by~     other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these~     data, change will be measure from baseline at 10 weeks (after 20 sessions).~   "
14291|NCT02870244|"~     Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene~     modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded~     investigator initiated therapy for patients with advanced melanoma.~   "
14293|NCT02870218|"~     Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes~     will be recruited and randomly assigned to one of five groups (n=64/group), who will be~     asked to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to~     subjects' menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine~     (standardized nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group~     will include 32 heavy, long-time smokers (≥ 10 cigarettes/day for ≥ 10 years), and 32 light~     smokers with a shorter smoking history (<10 cigarettes/day for <10 years), who are~     hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also~     have free access to nicotine-containing e-cigarettes (15 mg/ml) throughout the 12-week~     period. Abuse liability of combustible cigarettes will be assessed by behavioral~     (cigarettes/day, time to first cigarettes), self-report (rewarding effects, withdrawal~     symptoms) and biochemical indices (expired air carbon monoxide, cotinine blood sampling).~   "
14294|NCT02870205|"~     Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo~     NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis~     (subjects 12 years of age and older)~   "
14295|NCT02870192|"~     Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative~     adverse events is scant. A multicenter pool-analysis of prospectively collected database on~     1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients~     experienced complications, 41 discovered and managed intraoperatively, 22 postoperative~     complications, and 9 required readmission. Despite accepted lower rate of morbidity, these~     results come from four well equipped European centers by four surgeons practiced at least~     200 LVMR.~   "
14296|NCT02870179|"~     The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical~     Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during~     non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse~     Oximeter.~      The study is observational in nature which quantifies device performance and accuracy in~     compassion to a Reference Pulse Oximeter.~   "
14297|NCT02870166|"~     Given the structural essential, catalytic and co-catalytic played by zinc in many sections~     of protein metabolism, carbohydrate and lipid (zinc is involved in the function of more than~     300 metalloenzymes and metalloproteins), one can imagine the impact of a deficiency or even~     a sub-chronic zinc deficiency on the health of the individual. Studies multiply that show~     that, long-term, marginal zinc deficiency is a risk factor for the development of cancer or~     neurodegenerative complex diseases (eg Alzheimer's disease). In addition, the short-term~     zinc deficiencies foster the development of skin conditions and susceptibility to viral and~     bacterial infections. The aim of this project is to identify, in the population of patients~     with pseudo-acrodermatitis enteropathica (AE) tested in the investigators laboratory, rare~     variants (mutations real epimutations or polymorphisms) located in solute carrier family~     39 member 4 (SLC39A4) gene or in 55 other genes chosen for their role in zinc homeostasis.~   "
14298|NCT02870153|"~     The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and~     Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal~     cancer.~   "
14299|NCT02870088|"~     The purpose of this project is to investigate the effect of breaking prolonged sitting on~     acute adipose tissue and metabolic responses.~   "
14300|NCT02870075|"~     The purpose of this study is to investigate whether dietary conditions (fed versus fasted)~     affects the acute responses to exercise.~   "
14301|NCT02870062|"~     The search for preventive measure with daily bathing with chlorhexidine in the critical care~     patient will result in a reduction in patient colonization with multidrug resistant~     pathogens. Thus, preventing healthcare associated infections. The aim of this study was to~     determine the impact of daily bathing with chlorhexidine in patient colonization,~     environment and healthcare workers in the medical intensive care unit (MICU).~      The study will be conducted at the University Hospital Dr. José Eleuterio González, a~     450-bed teaching hospital in Monterrey, northeast Mexico.~      This is a prospective, experimental, randomized, open-label, double blind study comparing~     chlorhexidine versus placebo. Any patient 18 years or older admitted to the MICU or with~     less than 48 hours of patient-days will be included. Patients who present burns with more~     than 20% body surface, pregnant patients and patients with allergy history to chlorhexidine.~      Samples will be obtained from the patient, patient environment and healthcare personnel.~      Sampling of the environment (bed rail, mechanical ventilator, table adjacent to the bed,~     etc.) and patient's anogenital and pharyngeal region will be collected with swabbing~     technique using cotton swabs and cultured according to Public Health England.~      Patient skin sampling will be obtained from anorectal region, pharynx, axillary and inguinal~     fold collected with Williamson-Kligman technique. Colonies will then be further selected and~     properly cultivated according to their characteristics. Antibiotic susceptibility, clonal~     relationship, biofilm index and antibiotic susceptibility to chlorhexidine will be~     determined.~      Demographics and clinical data will be collected from admission, throughout hospitalization~     and discharge.~   "
14302|NCT02870049|"~     The purpose of this study is to determine whether inreach and outreach strategies will be~     superior to usual care, and combination of both will be superior to either strategy alone.~   "
14303|NCT02870036|"~     This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of~     Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and~     Leucovorin Calcium in patients with advanced solid tumor or advanced/metastatic colorectal~     cancer.~   "
14304|NCT02870023|"~     Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor~     control, and compromised gait function. Reduced walking speed, balance, and fatigue are the~     cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There~     is increasing scientific support of strength training for improving walking function. The~     evidence for balance training remains flawed. It is known that neurological damage in MS~     leads to increased cognitive processing in the planning of movements, which predisposes~     fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that~     motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.~      Purpose: The aim of the study is to determine whether there is a differentiated effect~     between strength and balance training measured by motor function, strength, balance, and~     fatigue.~   "
14305|NCT02870010|"~     Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)~        -  classical chemoembolization consists in injecting an emulsion of an anticancer agent in~          Lipiodol® via the hepatic artery~        -  doxorubicin, an anthracycline, is the most frequently used drug in lipiodol~          chemoembolization (LCE)~        -  however, less than half of HCC respond favourably to classical lipiodol~          chemoembolization (LCE) with doxorubicin/Lipiodol®~      In this trial, we propose to introduce in clinical practice a strategy based on idarubicin~     to achieve a more effective antitumor effect for the following reasons, recently pointed out~     by our team:~        -  idarubicin is an anthracycline that penetrates tumour cells more quickly and is more~          cytotoxic than doxorubicin on hepatocellular carcinoma cell lines~        -  idarubicin is injected in a solution of embolization microspheres of a diameter of~          (300-500µm), which all the progressive and controlled release of the anticancer drug,~          whereas the doxorubicin/Lipiodol® emulsion is unstable~   "
14306|NCT02869997|"~     The aim of this study is to evaluate the prognostic value of the suppression ratio monitored~     by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient~     admitted to our intensive care unit after a cardiac arrest are included. The results of the~     suppression ratio will be collected in the 6 first hours of admission. We will evaluate the~     link between suppression ratio and cerebral performance category score collected at three~     months.~   "
14307|NCT02869984|"~     Poor functional outcomes has been reported inevitably, and up to 90% of the patients have~     experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But,~     currently there has been no specific treatment for ARS and symptom based empirical~     management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D,~     and has been revealed to be slowing the bowel movement and improving stool consistency and~     urgency.~      We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS~   "
14308|NCT02869971|"~     The primary objective of this trial is to compare the 9-month effect on lower urinary tract~     symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard~     Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with~     symptomatic BPH who failed after a first line medical treatment with alpha-blockers.~      The secondary objectives of this study are to:~        -  Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health~          Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well~          as the side effects of the 2 strategies;~        -  Report the safety of PAE;~        -  Evaluate patient's adherence to medical treatment;~        -  Analyse the costs of each strategy and report the incremental efficiency (incremental~          cost utility ratio) of prostatic artery embolization compared to medical treatment.~   "
14309|NCT02869958|"~     It is recommended that patients with asthma owned a written action plan which must include~     the names, doses and dosing of the treatment they should take when acute respiratory~     symptoms occur.~      Current written action plans must be short to be readily used (1 page) and, therefore,~     cannot fit all acute situations. Moreover, they may not be available where and when~     required.~      The investigators sought that a digital action plan, available through Smartphone or tablet~     computer connected to the internet, could adequately provide suitable action plans according~     to the severity of the described exacerbation, and would be more easily available when~     useful.~      The aim of the study is to study the effect of the use of a digital action plan for asthma~     exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to~     physicians or to emergency departments, hospitalizations) in children and in adults with~     asthma. The investigators hypothesized that the use of the digital action plan could reduce~     avoidable unscheduled visits due to mild or moderate exacerbations that could successfully~     be managed by the patient or his/her caregivers.~   "
14310|NCT02869945|"~     Parkinson's disease onset is clinically defined as the appearance of motor symptoms~     including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms~     occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence~     suggesting that the level of dopaminergic denervation is not homogenous at the time of~     diagnosis.~      Some patients have a higher level of dopaminergic loss at disease onset indicating the~     existence of compensation mechanisms. The aim of this study is to decipher how the~     metabolism of dopamine is involved in this compensation with a focus on the polymorphism of~     the COMT gene. This gene is expressed according to two variant: (i) COMT H that encodes a~     form of the enzyme with a high level of activity and (ii) COMT L that encode a form of the~     enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population:~     (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated~     with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and~     COMT LL).~      The hypothesis is that this polymorphism of the COMT gene may participate to compensation~     mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms~     onset than patients with COMT LL genotype.~      To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17~     patients for each genotype). Given the distribution of COMT polymorphism in the population,~     a maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.~      Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms~     scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's~     disease behavioral assessment scale (ECMP). All the patients will have a monophotonic~     emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic~     denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be~     optional and will allow direct measurements of dopamine metabolites.~      The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane~     scans according to COMT genotype, age, gender and severity of motor symptoms on the~     MDS-UPDRS part 3.~      If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in~     order to delay dopaminergic drugs initiation for PD patients.~   "
14311|NCT02869932|"~     The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive~     Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net~     at day 21. This strategy has significantly improved the performance of CF neonatal screening~     (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties.~     Up to 85-90% of CF patients detected through the NNS program has a classical CF form with a~     positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR~     mutations with at least one non-CF causing mutation and a sweat test <60mmol/L or 1, 0 CFTR~     mutation and an intermediate sweat test value ≥ 30 et < 60mmol/L raising a diagnosis and~     prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic~     over time, some will develop symptoms prompting clinicians to maintain a rigorous~     surveillance for the entire atypical cohort, whose modalities vary a lot among centers and~     countries.~      This prospective multicenter study with a standardized assessment of a matched cohort with~     atypical CF versus classical CF from 6 years of age (60-65 cases in each cohort) is~     aimed at evaluating pulmonary and nutritional status to, better define the best monitoring~     follow-up, therapeutic management and familial genetic counseling.~   "
14312|NCT02869919|"~     This study aims to investigate whether there is a difference in Vitamin D levels between~     critically ill adult patients with and without acute kidney injury.~   "
14313|NCT02869906|"~     Functional assessment of non-culprit lesions during percutaneous coronary intervention (PCI)~     in patients with acute coronary syndrome could improve risk stratification and shorten the~     duration of hospital stay by decreasing the need for additional non-invasive stress testing~     to detect residual myocardial ischemia. The investigators aimed to assess the reliability of~     the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in~     non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation~     myocardial infarction (STEMI).~   "
14314|NCT02869893|"~     The goal of this research study is to learn more about the pancreas. The investigators want~     to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a~     normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the~     pancreas. The investigators also want to figure out how much fluid the pancreas releases in~     response to secretin. Secretin is a chemical in the body that causes the pancreas to release~     fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify~     dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the~     pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.~   "
14315|NCT02869880|"~     Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster~     randomized controlled trial to determine whether, in parents (of children with Crohn's~     Disease) or patients > 18 years old being approached for trial participation, a pre-consent~     discussion enhanced with decision aids is more effective than the standard pre-consent~     discussion in transferring knowledge to parents/patients related to trial participation.~   "
14316|NCT02869867|"~     Nursing study, prospective, randomized, two-center open-label.~      Patients will be randomized into two groups during their first laying Qutenza®:~        -  Patients receiving the laying of Qutenza® without refrigerated cushion~        -  Patients receiving the laying of Qutenza® associated with a refrigerated cushion~      The objective of the study is to evaluate the effectiveness of the application of cold to~     the reduction of pain (burning) after one hour of patch installation high concentration~     capsaicin (Qutenza®) in patients localized neuropathic pain.~   "
14317|NCT02869854|"~     In a pilot study 90 physically inactive patients will be randomized to three different~     intervention groups; mindfulness training, mindfulness training and Physical Activity~     Referral scheme (PARs) or only PARs Follow-up will be done at baseline, three and six months~     with questionnaires, accelerometers and analysis of traditional risk factors to evaluate~     whether mindfulness may increase physical activity and decrease physical inactivity.~   "
14318|NCT02869841|"~     Midline laparotomy is commonly used in emergency and elective cancer surgery and patients~     need effective and safe pain treatment after this type of surgery. Nowadays modern~     anticoagulant therapy may prevent use of central regional blocks in pain management.~     Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied~     using different administration techniques. The primary aim is the efficacy of the rectus~     sheath analgesia measured with pain ratings and the amount rescue opioid used.~      Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to~     analgesia method used.~   "
14319|NCT02869828|"~     Core temperature monitoring is mandatory during major surgery. The accurate techniques~     currently used are invasive, such as artery catheter and oesophagal probe. A new~     non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure~     core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to~     oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients~     during surgery.~   "
14320|NCT02869815|"~     The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant~     chemotherapy is controversial. Lower detection rate and higher false negative rate are the~     main problem. The purpose of this study is to determine the detection rate and the false~     negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue)~     after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer.~     This is a single arm clinical trial.~   "
14321|NCT02869802|"~     Researchers are looking for better ways of understanding and treating pancreatic cancer. The~     purpose of this study is to see how useful it is to look for changes and characteristics in~     your genes (molecules that contain instructions for the development and functioning of the~     cells) and the genes within the tumour. These characteristics may be useful in choosing~     treatments for patients in the future. Changes (mutations) in genes have been shown to be an~     important characteristic in cancers. Looking at differences in genes in patients with~     advanced pancreatic ductal adenocarcinomas and comparing this information with response to~     their initial chemotherapy treatment may help to learn which treatments may be better for~     certain patients after initial treatment.~   "
14322|NCT02869789|"~     A study to evaluate the safety of Nivolumab administered in combination with Ipilimumab in~     patients with advanced cancers. The initial cohort will enroll patients with newly diagnosed~     Stage 4 or recurrent non-small cell lung cancer.~   "
14323|NCT02869776|"~     The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in~     high prevalence settings, such as detoxification centers with a large proportion of young~     injection drug users. The latest venipuncture testing will be compared to rapid finger stick~     testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a~     short-term drug detoxification center will be determined.~   "
14324|NCT02869763|"~     The aim of the clinical trial is to study the intra-individual variation of steroid profile~     parameters after experimental administration of different doses of ethanol in Caucasian~     women.~   "
14325|NCT02869750|"~     To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin),~     in obese and non-obese patients with polycystic ovary syndrome (PCOS).~   "
14326|NCT02869737|"~     Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its~     detection mainly relies upon classic biological test like the prothrombin time and the~     international normaliezd ratio (INR). These tests are not available at the bedside. Point of~     care (POC) device for INR measurement are now available like the Coaguchek, Roche, France.~     The aim of the present study is to test the correlation between the POC INR and the~     laboratory INR.~   "
14327|NCT02869724|"~     This study will evaluate the efficacy of an advice with a weekly divided drug delivery,~     compared to an usual monthly delivery in the prevention of voluntary drug intoxications~     repeated.~   "
14328|NCT02869711|"~     The present study focuses on the quality of care and how the health executives can bring it~     to a central place in their management. A training-action has been set-up at the Health~     Executive training institute (University Hospital Grenoble) to improve care quality. Reports~     prepared by students (tutored projects) related to operational diagnosis and action plans~     about care quality improvement are given to health executives. The objective is to evaluate~     how the health executive will use the tutored project to improve care quality and set-up~     actions.The hypothesis is that the health executive will use the tutored project to improve~     project management.~   "
14329|NCT02869698|"~     This prospective research aims to develop the use of Spectral Imaging in addition Dynamics~     of cortical electrical stimulation to identify major anatomical and functional networks in~     epileptic patients candidates for surgery and explored by stereoencephalography, to minimize~     risk of post-surgical cognitive deficits.~   "
14330|NCT02869685|"~     The detection of tissue PD-L1 immunohistochemistry in NSCLC has an important role in guiding~     for the treatment of immune detection point.Radiation therapy can enhance the effect of~     immunotherapy,but radiation dose and timing are waiting to be solved. At the same~     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the~     information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple,~     rapid, non-invasive means of detection. The project is planned to explore the consistency~     analysis of PD-L1 expression level detected in tissues and pExo before and after~     radiotherapy.We have designed five kinds of radiation-division with bioequivalent doses, and~     detected the expression levels of PD-L1 in pExo after 24h, 48h of each stage of~     radiotherapy.PD-L1 mRNA levels in pExo detected at different time points,by using variance~     analysis of repeated measures design information.Probing the best timing and manner of~     radiotherapy division which can make PD-L1 express more,guiding clinical practice of~     radiotherapy combining with immunotherapy.~   "
14331|NCT02869672|"~     This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal~     Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3~     group according to their age, receiving the test vaccine and the control vaccine at the~     proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.~   "
14332|NCT02869659|"~     This randomized controlled clinical trial will use methylomic and transcriptomic profiling~     to examine the effects of a weight loss intervention on the cholesterol metabolism gene~     network in monocytes and adipocytes and investigate the longitudinal relationship between~     these modifications and glycemic improvements.~   "
14333|NCT02869646|"~     Current treatments for Veterans with PTSD include medications and therapy where the patient~     talks about traumatic events in order to desensitize to them. While these treatments work~     for many, a large minority of Veterans do not want medications or exposure therapy. The~     investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden~     treatment options. The investigators' first study showed that it helped most people.~     However, the investigators need better scientific evidence that it works by comparing ACU to~     a placebo, such as sham acupuncture (fewer needles in non-important sites) and determining~     if ACU alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly~     assigned (like a coin flip) to receive either ACU or sham. The investigators expect to find~     that the ACU treated patients have more improvement in PTSD and in physiology (less startle~     reaction - assessed non-invasively using skin sensors) than the patients in the sham group.~     This study will provide information to support the use of acupuncture for PTSD at the VA,~     which will expand treatment options.~   "
14334|NCT02869633|"~     This phase II trial studies how well ibrutinib works in treating patients after a donor stem~     cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
14335|NCT02869620|"~     Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer~   "
14336|NCT02869607|"~     Database of Institut Paoli-Calmettes patients diagnosed with breast cancer~   "
14337|NCT02869594|"~     Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer~   "
14338|NCT02869581|"~     Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms~   "
14339|NCT02869568|"~     Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer~   "
14340|NCT02869555|"~     Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma~   "
14341|NCT02869542|"~     Database of Institut Paoli-Calmettes patients diagnosed with lymphoma~   "
14342|NCT02869529|"~     Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia~   "
14343|NCT02869516|"~     Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia~   "
14344|NCT02869503|"~     Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer~   "
14345|NCT02869490|"~     Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer~   "
14346|NCT02869477|"~     Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer~   "
14347|NCT02869464|"~     The purpose of this study is to examine the percentage of patients who present with~     abdominal aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely;~     to examine the percentage of patients who present with intracranial aneurysms will also have~     abdominal aortic aneurysms.~   "
14348|NCT02869451|"~     The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation~     treatment. The intervention combines mobile technology with behavioral strategies,~     counseling, and medications.~   "
14349|NCT02869438|"~     The purpose of this study is to investigate the onset and maintenance of effect of~     benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life~     during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic~     inflammation. A subset of patients will take part in body plethysmography substudy to~     further investigate the effect on lung function.~   "
14350|NCT02869425|"~     This study is designed to assess the effects of a therapeutic dose of arbaclofen extended~     release (ER) tablets compared with placebo on human sperm concentration, motility, and~     morphology in male subjects with multiple sclerosis (MS).~   "
22680|NCT02760290|"~     Cesarean section will performed via intraperitoneally and extraperitoneally. During~     postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel~     movement, discharged time will be compared.~   "
14352|NCT02869399|"~     This is an open-label randomized phase II multicenter trial. An estimated 350 patients~     deemed to be in complete remission at month 3 after curative treatment are considered for~     this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on~     dietary intervention in addition to standard recommendations and a control arm (arm B)~     including only standard recommendations. The intervention strategy is based on the AICR/WCRF~     recommendations for cancer and recurrences prevention and it is focused on decreasing~     inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction~     in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two~     arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time~     trend in the prevalence of side effects and quality of life, as assessed by the EORTC~     QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA)~     will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and~     conducted in 6 European countries.~   "
14353|NCT02869386|"~     Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces~     alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest~     cost-effectiveness. However, scientific proof of improved functional outcome compared to~     usual care is still lacking. The objective of this trial is to show improved functional~     outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.~   "
14354|NCT02869373|"~     The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization~     exercise program on pain, trunk muscle endurance and postural stability in women with benign~     joint hypermobility syndrome~   "
14355|NCT02869360|"~     Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled~     clinicians to measure disease activity but there are inherent limitations.~     Clinical/radiographic dissociation can be seen in some patients and the abnormalities are~     not specific.~      This pilot study is an opportunity to determine the relationship between quantitative~     advanced MRI measures and OCT with PET measurements of microglial activation and myelin~     health.~   "
14356|NCT02869347|"~     Iodinated contrast media have been causally linked to acute kidney injury known as~     contrast-induced nephropathy (CIN), which is the consequence of CM-induced local renal~     ischemia and direct toxic effects. Conestat alfa (recombinant human C1 esterase inhibitor)~     has been shown to decrease renal ischemic damage in experimental models of renal ischemia.~      The Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced~     Nephropathy in High-risk Subjects (PROTECT) Study is a randomized, placebo-controlled,~     double-blind single-center trial that will assess the effect of prophylactic administration~     of Conestat alfa on the degree of acute kidney injury subjects undergoing elective coronary~     angiography. Patient with an estimated glomerular filtration rate <=50 ml/min/1.73 m2 and at~     least one additional risk factor for CIN will be enrolled and randomly assigned to 1)~     Conestat alfa at 50 U/kg given as intravenous injection immediately before and 4 hours after~     coronary angiography or 2) placebo (sodium chloride). All patients will receive standard~     intravenous hydration with isotonic saline. Surrogate markers of kidney injury will be~     assessed over a 48 hours time period. Patients will be followed for cardiovascular and renal~     events over 12 weeks.~      The primary outcome measure is peak change in urinary Neutrophil gelatinase-associated~     lipocalin within 48 hours after elective coronary angiography.~   "
14357|NCT02869334|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS), when combined with different forms of computer based training, improves the ability~     to discriminate small differences between sounds in people diagnosed with schizophrenia or~     schizoaffective disorder.~   "
14358|NCT02869321|"~     Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be~     performed with a radiological approach. This procedure is usually not performed under~     general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric~     insufflation and incision of the abdominal wall. Standard analgesic treatments are usually~     not well-fitted due to onset of action or route of administration. An alternative solution~     could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use~     allowing repetition if needed, during the procedure.~      The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT®~     to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®),~     in radiologic percutaneous gastrostomy tube placement:~        -  during the procedure~        -  following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30~          min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).~      Secondary purposes are to compare easiness of 2 treatments and their adverse effects.~   "
14359|NCT02869308|"~     The purpose is to determine whether measurements of left ventricular ejection fraction~     (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera~     are equivalent.~      Secondary purposes are:~        -  To evaluate the influence of cardiac activity recorded by D-SPECT camera on~          equivalences defined in primary purpose~        -  To evaluate the influence of the indication for the examination with a distinct~          analysis of a group having the examination for a known or suspected cardiomyopathy~          (LVEF often abnormally low) and a group having the examination for a chemotherapy~          supervision with heart initially considered healthy (LVEF often normal).~   "
14360|NCT02869295|"~     This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study~     of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.~   "
14361|NCT02869282|"~     Multicentric, observational, prospective, non-interventional study with occasional~     biological sample collection (serum bank, urine bank and tumor bank)~   "
14362|NCT02869269|"~     Previous studies have shown that colorectal cancer patients' prognosis and overall survival~     was related with immune cell expression in patients' tissue. However, the circulating immune~     cell activity changes in patients' blood has few studies. The purpose of this study is to~     analyze the variation of circulating immune cell activity in colorectal patients' blood~     which is classed as clinical staging.~   "
14363|NCT02869256|"~     It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous~     leukemia cases of registration (CML) prospectively and retrospectively.~   "
14364|NCT02869243|"~     The purpose of the study is to evaluate the feasibility and safety of intra-tumor and~     interstitial therapy with hBMP4 in increasing doses in patients with progressive and/or~     multiple recurrent Glioblastoma multiforme (GBM).~   "
14366|NCT02869217|"~     The target populations for this phase I study with TBI-1301 are patients with advanced solid~     tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not~     limited to ovarian cancer, synovial sarcoma, esophageal cancer and malignant melanoma.~     Patients must be positive for HLA-A*02:01 or HLA-A*02:06 and the patient's tumor tissue must~     be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells,~     which are a natural type of immune cell in the blood, and send them to a laboratory to be~     modified. The changed T cells used in this study will be the subject's own T cells that have~     been genetically changed with the aim of attacking and destroying cancer cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion. The purpose of this study is to test the~     safety of genetically changed T cells and find out what effects, if any, they have in~     subjects with advanced solid tumors.~      The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the~     recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide~     pre-treatment and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.~   "
14367|NCT02869204|"~     The purpose of this project is to investigate whether a combination of a local injection of~     platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine,~     as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote~     tissue healing in patients undergoing open upper-abdominal surgery.~      Primary endpoint is cases of wound infection and secondary endpoints are time of tissue~     regeneration (days), judged by traditional clinical observation and experimentally assessed~     by ultrasound.~      The experiment is performed as a parallel two-armed, randomized, controlled trial.~      A total of 40 subjects will be included in the trial i order to ensure the power of the~     study, despite a drop off of up to 25%.~   "
14368|NCT02869191|"~     The purpose of this study is to assess the blood cultures' profitability in intensive care~     unit and create a validated prediction rule for extractioning in critical patients.~   "
14369|NCT02869178|"~     Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to~     severe exhibit significant reduction in the ability to exercise compared to those with mild~     dysfunction , and have worse prognosis. However, some clinical markers of severity and~     diagnosis widely used in this population such as ejection fraction (EF) , are not always~     able to translate the actual degree of cardiac damage as well as their relationship with the~     cardiorespiratory fitness of these individuals and prognosis .~      Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting~     exercise tolerance in heart failure patients with moderate and significant systolic~     dysfunction.~   "
14370|NCT02869165|"~     A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal~     alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of~     menopause.~   "
14371|NCT02869152|"~     The purpose of this study is to develop a technique that allows physicians to identify the~     first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there~     is no technique used to find these lymph nodes in the rectum during surgery and therefore~     many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers,~     imaging and a gamma probe will be used in this study during a standard minimally invasive~     transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able~     to locate these lymph nodes they will be removed during surgery. If the technique is~     successfully developed as a result of this research, it could help patients in the future~     with early stage rectal cancer by allowing doctors to see if their cancer has spread to the~     lymph nodes of the rectum without having to undergo a total rectal resection. These patients~     would then be able to undergo a TES combined with a lymph node dissection to gain more~     knowledge about the stage of their disease. This knowledge would then be used to determine~     if and what further treatment is necessary for the patient's rectal cancer.~   "
14372|NCT02869139|"~     Package of mentholated measures for the relief of thirst in the anesthesia recovery room:~     Randomized clinical trial~   "
14373|NCT02869126|"~     The purpose is to demonstrate the concordance of diagnostic information obtained with:~        1. a conventional examination with 2 distinct recordings on D.SPECT camera after~          99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours~          later,~           and~        2. a double isotope examination with a supplementary recording after injection of a little~          activity of thallium-201 at rest after the first recording and before the second~          injection of 99mTc-sestamibi for conventional recording at rest,~      in patients showing abnormalities of myocardial perfusion in stress myocardial~     tomoscintigraphy.~   "
14374|NCT02869113|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist.~   "
14375|NCT02869100|"~     The purpose is to compare detection of axial inflammatory lesions in patients affected by~     spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic~     resonance imaging (MRI), the reference technique.~      It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis~     of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of~     patients with early forms of spondyloarthritis.~      Secondary purposes are:~        -  To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage~          (except spine and sacroiliac joints)~        -  To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and~          compare these data to clinic-biologic parameters used in clinical practice (BASDAI,~          BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural~          evaluation (sacroiliac New York, mSASSS and BASRI scoring methods)~        -  To study correlation of axial and peripheral bone inflammation (spine and sacroiliac~          joints) evaluated with sodium fluoride PET with biologic markers of inflammation and~          bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α).~      Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI.~     It is interesting to compare to activity obtained with PET. Moreover, it has been recently~     showed the disassociation of inflammation and structural progression (anti-TNF treatments do~     not prevent structural progression) that is associated to markers of bone remodeling whose~     activity is influenced by an activation/inhibition system of biologic markers of~     inflammation.~   "
14376|NCT02869087|"~     The aim of this study is to prospectively collect information to evaluate the safety and~     performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system~     for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the~     superficial femoral artery (SFA).~   "
14377|NCT02869074|"~     The present Project is a third phase of the previous PCM-EVW-ES Project (Batlle et al.~     Thromb & Haemost 2015) with the aim of its extension, further analysis with an innovation~     development in the field of von Willebrand disease (VWD) based in the newer recently~     available methodologies. The aim of this project is to help the physician in a more uniform~     characterization and therapy of VWD in clinical practice, at an international level. A~     reduction of the expenses in the diagnosis process by using the new methodologies is~     pursued.~   "
14378|NCT02869061|"~     Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by~     enzymatic digestion from a portion of the fat harvested from the patient's front abdominal~     wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension~     will be performed. This is a single arm study with no control. All patients receive cell~     therapy.~   "
14379|NCT02869048|"~     Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to~     destruction of the neural pathways which control the conscious movements of the muscles.~     This destruction leads to muscular dystrophy with increasing difficulties in moving,~     breathing, swallowing, and speaking. In the last phase of an ALS patient's life it is~     necessary with respiratory therapy in order to breathe. In average an ALS patient lives 3~     years from the time he or she gets the diagnose.~      The cause of the disease is still unknown and there is currently no treatment which can stop~     the progression of the disease. Former clinical studies have indicated that the innate~     immune system and in particular the complement system plays a significant role in the~     progression of ALS. The complement system, which is activated in cascades, is part of the~     innate system but participates in the innate as well as the acquired immune system. Former~     clinical trials have been characterized by limited knowledge about both the complement~     system as well as to how it is measured.~      Today it is possible to measure directly on the different components of the complement~     system and to understand its contribution to the overall immune response. It is also~     possible today to detect defects of the complement system. All these progressions are the~     foundation for this project which is carried out in close cooperation with one of the~     world's leading researchers in the complement system, professor Peter Garred from~     Rigshospitalet.~      The aim is to make a national research project about ALS in order to investigate the role of~     the innate immune system, and especially the complement system, in patients with ALS.~      In the long term the hope is, that this will lead the way to a targeted and effective~     medical treatment to the people affected by this grave disease.~   "
14380|NCT02869035|"~     Major Depressive Disorder (MDD) is one of the most severe and frequently occurring brain~     disorders worldwide. It has been linked to serotonergic dysfunction, sexual dysfunction,~     vulnerability to stress and neuro-inflammation. However, at the same time the etiological~     understanding is limited. Most antidepressants act on the serotonin (5- HT) system, yet~     between 30-50 % of patients with MDD does not respond successfully to 5-HT acting drugs.~     Recent experimental models from our group suggest that cerebral 5-HT levels in vivo can be~     indexed through molecular brain imaging of the 5-HT 4 receptor (5-HT4R) with a novel~     Positron Emission Tomography (PET) ligand (11C-SB207145). Also, our human studies have~     confirmed that cerebral synaptic 5-HT is inversely related to 5-HT4R binding and this~     technique thus can be used to investigate the role of 5-HT tone in the brain in MDD with~     differential responses to standard antidepressant treatment. By using multimodal~     neuroimaging technology, we aim to determine the status of the 5-HT system prior to and~     after either successful or failed neuropharmacological intervention in a non-randomized~     longitudinal open clinical trial. 100 untreated patients with moderate to severe MDD will be~     included. Data collection from various neurobiological domains (i.e, 5-HT4R PET imaging,~     Magnetic Resonance Imaging (MRI), functional MRI (fMRI), electroencephalogram (EEG),~     psychometrics, neuropsychological tests, and peripheral biomarkers) will be conducted~     before, during and after 12 weeks of antidepressant treatment. The objective is to identify~     predictors of pharmacological antidepressant treatment response in depressed individuals~     before and after 8 weeks of antidepressant treatment.~   "
14381|NCT02869022|"~     The objective of this investigation is to demonstrate non-inferiority in outcome of~     Custodiol-N against Custodiol in heart transplantation.~   "
14382|NCT02869009|"~     The risk of early recurrence or progression of acute ischemic stroke is very high, even in~     patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment~     reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or~     minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased~     hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the~     dual antiplatelet treatment could reduce the risk of early recurrence or progression in~     patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators~     hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in~     this group of patients.~   "
14383|NCT02868996|"~     This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in~     healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous~     dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.~   "
14396|NCT02868827|"~     The purpose of the research study is to determine whether a single high dose of vitamin D is~     helpful in reducing critical illness related complications in intensive care patients who~     are having sever vitamin D deficiency.~      Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A~     number of scientific studies have documented a strong correlation between low levels of~     vit.D and increased rate of adverse outcomes including infection, acute kidney injury and~     mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated 50%~     reduction in hospital mortality in severe vit.D deficient patients following a single high~     dose of cholecalciferol (Vitamin D3). However the role of Vit.D supplementation to boost up~     host immune system and eventually reduction of mortality has yet to be determined by large~     randomized controlled trails in humans. Hence we aim to run a randomized controlled trial~     (RCT) in order to study the role of Vitamin D in critically ill patients.~   "
14384|NCT02868983|"~     Behavioral problems are part of many of the chronic diseases that cause the majority of~     illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse,~     failure to take treatment, sleep problems, anxiety, depression, and stress are major issues,~     especially when chronic medical problems such as heart disease, lung disease, diabetes, or~     kidney disease are also present. These behavioral problems can often be helped, but the~     current health care system doesn't do a good job of getting the right care to these~     patients.~      Behavioral health includes mental health care, substance abuse care, health behavior change,~     and attention to family and other psychological and social factors. Many people with~     behavioral health needs present to primary care and may be referred to mental health or~     substance abuse specialists, but this method is often unacceptable to patients. Two newer~     ways have been proposed for helping these patients. In co-location, a behavioral health~     clinician (such as a Psychologist or Social Worker) is located in or near the primary~     practice to increase the chance that the patient will make it to treatment. In Integrated~     Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely~     with the medical provider as a full member of the primary treatment team.~      The research question is: Does increased integration of evidence-supported behavioral health~     and primary care services, compared to simple co-location of providers, improve outcomes?~     The key decisions affected by the research are those made at the practice level: whether and~     how best to use behavioral health services. For patients, whether to seek out or accept~     offered behavioral health services will be influenced by the manner they are made available.~      The investigators plan to do a study of 40 practices which will each start off using~     co-location. Over time, each one will convert to IBH using a practice improvement method~     that has helped in other settings. The investigators will measure the health status of~     patients in each practice before and after they start using IBH. The investigators will~     compare the change in those outcomes to health status changes of patients in practices who~     have not yet started using IBH.~      The investigators plan to study adults who each have both medical and behavioral problems,~     and get their care in Family Medicine clinics, General Internal Medicine practices, and~     Community Health Centers.~   "
14385|NCT02868970|"~     This project proposes to implement and compare new community pharmacy-based strategies for~     improving vaccine coverage.~   "
14386|NCT02868957|"~     The objectives of this study were to compare the precision of two digital intraoral scanners~     from a series of repeat scan images, and to investigate the effect of the learning curve on~     changes in trueness when scanning the full arch of the oral cavity in actual patients.~   "
14387|NCT02868944|"~     The addition of morphine to a local anesthetic when performing an epidural analgesia during~     labor analgesia has improved the efficiency and the action duration of analgesia. One~     limitation of this technique is the time of installation of the analgesic effect (about 30~     minutes) when using the only epidural. Therefore, the technique of sequential combined~     spinal epidural was introduced. This is to shorten the installation time by direct injection~     into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has~     been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could~     potentiate the effect of the local anesthetic.~   "
14388|NCT02868931|"~     This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly~     developed treatment and education programme for diabetic patients with an insulin pump~     therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the~     difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome~     variables are: diabetes-related distress, depressive symptoms, health-related quality of~     life, diabetes self-efficacy, self-care behavior, hypoglycemia awareness, and attitudes~     towards insulin pump therapy.~   "
14389|NCT02868918|"~     The aim of this study is to compare the effect of new bioactive dentine substitute~     (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and~     radiographically using digital radiography in the terms of postoperative pain and~     biocompatibility to the pulp.~   "
14390|NCT02868905|"~     The purpose of this study is to compare average methylation of epigenetic markers on genomic~     DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:~        -  Of obese young adults and healthy young adults~        -  Of obese young adults and individuals affected by Alzheimer's disease (AD) having been~          obese at young adult age (<50 years old) or individuals affected by Alzheimer's disease~          (AD) having never been obese.~      The secondary purpose is to determine if there is an association between the frequency of~     these epigenetic markers and elements associated to the metabolic syndrome (lipidic and~     glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass,~     body mass index) in young adults.~   "
14391|NCT02868892|"~     Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the~     cervix will receive Pemetrexed.~   "
14392|NCT02868879|"~     The different subtypes of Schizophrenia might have a disordered connectivity as their final~     common pathways.~      The investigators will use multimodal structural MRI to assess anatomical connectivity on~     the one side and its functional consequence on functional connectivity on the other side to~     assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with~     control subjects.~      The coherence between structural and functional anomalies will be especially studied.~   "
14393|NCT02868866|"~     The USC PRC's applied research project will study the dissemination and implementation of an~     evidence-based program shown previously to significantly increase physical activity and~     fruit and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition;~     FAN). Guided by two theoretical frameworks, the specific aims of the applied research~     project are to: 1) examine the adoption and reach of FAN in churches and organizational~     factors associated with adoption; 2) characterize implementation fidelity and multilevel~     factors associated with implementation; 3) describe organizational maintenance of FAN and~     factors associated with maintenance; and 4) study the effectiveness of FAN. In Phase 1,~     churches in a rural county with a high proportion of African American residents will be~     randomized to receive training in FAN from a community health advisor (n=40) or to be part~     of a delayed intervention control group (n=20). In Phase 2, a quasi-experimental study wil~     be done with a large religious denomination in SC (churches are not randomized).~   "
14394|NCT02868853|"~     The purpose of the study is to test the effectiveness of two different methods of mobile~     dietary self-monitoring for weight loss. Both of these interventions will provide weight~     loss information through twice weekly audio podcasts. In addition to the podcasts,~     participants will be asked to track their diet using an assigned mobile applications (for~     their smartphone), which will be randomly assigned.~   "
14395|NCT02868840|"~     Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by~     continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the~     integration and balance of mind and body using the fundamental principles of slow, smooth,~     and continuous movement control, and the transfer of body weight while maintaining an~     upright and relaxed posture. The present randomized clinical trial project aims to apply the~     suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and~     to evaluate the effects on physical (balance), psychological, and cognitive function.~   "
14399|NCT02868788|"~     This study will help elucidate the mechanism underlying the cardioprotective and~     anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and~     oxidative stress markers, based on a contemporary understanding of this process. In~     addition, there have been very few studies that explored the immediate change in oxidative~     stress and incretin secretion after fiber intake. In this study, the investigators will be~     able assess the short term metabolic impact of dietary fiber at great details. The result~     will contribute to dietary recommendation or designing of fiber supplementation for~     prevention/treatment of diabetes, obesity and cardiovascular disease.~   "
14400|NCT02868775|"~     This is a prospective pilot study, with a recruitment goal of 60 patients. Patients who are~     female, above the age of 18, and with a diagnosis of IC/BPS based on clinical criteria and~     O'Leary Sant ICPI and ICSI scores undergoing cystoscopy, hydrodistention and bladder biopsy~     will be included. The bladder biopsies will be evaluated for TLR4 expression, and sent for~     histological assessment of mast cell count. Additionally, data will be collected at~     baseline, day of surgery, day 7, day 14 and day 28. Data will include validated~     questionnaires, lower urinary tract symptoms, and recorded pain medication use.~   "
14401|NCT02868762|"~     This study investigates in patients whose primary complaint is either neck pain and/or a~     voice disorder , if there are any correlations between subjective neck and voice symptoms~     according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI~     questionnaire results for voice disordered patients will be retrieved from the data base of~     the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain~     patient questionnaire data will be retrieved from an ongoing study. The agreement between~     subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.~   "
14402|NCT02868749|"~     This study is a single-blind intra-individual comparative study to evaluate the short and~     medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA),~     designed for deep injection, that have been used for several years on a worldwide scale.~   "
14403|NCT02868736|"~     -  To demonstrate the tests' performance when compared to the detection of PJI using the~          Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for~          diagnosing PJI.1 This criteria-based definition of PJI places emphasis on culture~          techniques that identify pathogens, but also provides for minor criteria that can be~          used to diagnose PJI;~        -  To calculate the tests' clinical sensitivity, clinical specificity, positive predictive~          value (PPV), and negative predictive value (NPV).~   "
14404|NCT02868723|"~     This will be a prospective randomized 2 year study of patients admitted to the Hamad General~     Hospital (HGH) and the Stroke Prevention Clinic with a diagnosis of ischemic stroke (IS) and~     Transit ischemic attacks (TIAs). After signing of the informed consent forms and initial~     evaluation and investigations, all patients enrolled in the two arms ( study arm and control~     arm) of the study will be followed for one year (monthly visits for the first three months~     followed by visits three months until completion of study: total of 6 follow up visits) and~     the pre-specified investigations repeated at the one year follow up. In one arm (the control~     group), the patients will be offered best risk factor management strategies as currently~     being practiced by stroke specialists at HGH in Qatar. And in the second ( the subject~     group) arm, with assistance of a nurse-practitioner and pharmacist, the investigators will~     make aggressive attempts to meet to target defined risk factors and have the evaluations~     and investigations completed as in the initial year cohort. All patients will have risk~     factor stratification according the Framingham Risk Score (FRS) and the change in score~     measured over time.The primary objective will be to determine if an approach that utilizes a~     comprehensive strategy results in a significantly outcome. A clinically 'meaningful'~     difference in the blood pressure (BP) and lipid control of 10% between the aggressively~     managed versus patients treated with the standard of care will require minimum of 200~     patients in each group (alpha error set at 0.05 and beta error at 0.20, power 80%) to be~     recruited over 1 year and followed for one year (total study duration 2 years).~      All patients will have screening magnetic resonance imaging (MRI) (including gradient echo~     (GRE) sequence), carotid 3D Doppler measurement of plaque volume, and PAD assessments,~     C-reactive protein (CRP) and evaluation for protein urea at baseline. These studies will be~     repeated in 1 year at the time of exit from the study. The co-primary objective would be to~     monitor progression (or regression) of plaque build-up on 3D Doppler imaging of the carotid~     arteries between the two cohorts. The investigators hypothesize that aggressive management~     of vascular risk factors to recommended target levels will lead to better vascular health.~     Compared to current practice, comprehensive and coordinated approach at preventive measures~     will lead to more patients with better control of blood pressure and lipid levels. Improved~     risk factor management will result in slowing of atherosclerosis and its downstream effects~     which will be measurable on sophisticated blood and imaging testing. Clinically this will~     translate into fewer hospital re-admissions.~   "
14405|NCT02868710|"~     The purpose of this study is to: 1) determine the cohort specific technical error to use in~     the categorization of response rate; 2) determine if an individualized intensity~     prescription is superior to a standard approach in regards to VO2max and cardiometabolic~     risk factor responsiveness; 3) Investigate the time course changes throughout 12 weeks of~     CRF training between an individualized and standardized exercise prescription; and 4)~     determine if non-responders can become responders if the exercise intensity prescription is~     modified.~      It is hypothesized that:~        1. The individualized method will elicit a greater responsiveness for all measurements~          when compared to the standardized method.~        2. There will be a greater amount of non-responders in the standardized group (based on~          changes in VO2max).~        3. When participants in the standardized group are considered non-responders and change~          their exercise prescription to the individualized group, they will become a responder~          (based on changes in VO2max)~   "
14406|NCT02868697|"~     Goal of the study:~      A- To find out the best protocol for catheter lock solution to decrease the prevalence of~     catheter thrombosis~        1. - The time to first episode of catheter thrombosis lead to catheter change.~        2. - Number of acute episode of thrombosis that interrupt dialysis~        3. - Median Survival life of the catheter in both groups after adjusting it to the~          outcome.~      B- Specific Objective: To evaluate the cost effectiveness by measure~        1. Amount of r-TPA used in each group to treatment acute catheter thrombosis~        2. Number of catheter exchange in both group~        3. Hospitalization days related to catheter malfunctioning or CRI in each group~        4. Type and days of antibiotics~        5. Cost of the treatment in each group~           c- Secondary Objective:~           To correlate the result of two catheters lock solution protocols with the published~          data using r-TPA instead of heparin once week as compared with heparin 3 times per week~          as a locking solution.~   "
14428|NCT02868411|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of traveller's fever caused by known pathogens, close to~     the reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC traveller's fever tests .~      The objective of this study is to implement a new diagnosis strategy relying on the~     hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever~     of at least 10%.~   "
14407|NCT02868684|"~     This longitudinal cohort study aims to detect the topographical nature of the white matter~     microstructure and resting state functional connectivity patterns across the whole brain in~     the evolution of pathology as a function of time following mild TBI. All consecutively~     patients with the non-contrast head CT because of acute head trauma from the local emergency~     department (ED) formed the initial population of this study. Age, sex, education-level~     matched healthy controls will also be enrolled. The initial scan will performed within 7~     days post-injury. Clinical assessment was performed within 24 hours of MR imaging and~     included a broad neuropsychological and symptom assessments. Follow-up examination will~     conduct at 1 month, 3 month, 6-12 months.~   "
14408|NCT02868671|"~     The overall goal of this study is to examine if acupuncture intervention can reduce the~     onset of post-traumatic stress disorder (PTSD), and affective and cognitive complaints among~     mild traumatic brain injury (TBI). This study also hypothesized that compared to those in~     the sham acupuncture and waiting list control groups, patients in the real acupuncture group~     will have fewer symptoms of depressive symptoms, sleep problems and post-concussion~     symptoms.~   "
14409|NCT02868658|"~     Although clinical presentation of influenza is often symptomatic, asymptomatic cases also~     occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is~     very important because of the risk of cross-transmission to hospitalized patients. The~     principal objective of the study is to estimate the incidence of symptomatic and~     asymptomatic influenza among healthcare workers in short-stay wards. The results of this~     study will lead to a better understanding of the burden of asymptomatic influenza among~     healthcare workers and might be used as an argument to increase influenza vaccine coverage~     among healthcare workers.~   "
14410|NCT02868645|"~     Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been~     shown that periostin is over expressed in fibrous component in patients bones ; but~     periostin has never been measured out in serum of patients, although it is easy to assess.~     This study aims to show whether serum periostin is elevated in serum of patients with~     fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.~   "
14411|NCT02868632|"~     This is an open-label, three-cohort, phase Ib study to determine the safety, recommended~     phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in~     combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination~     of MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma~     of pancreas.~   "
14412|NCT02868619|"~     Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating~     medical and psychological consequences. 30% of obese suffer from BED type of eating~     disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of~     cases. Many arguments are in favor of the involvement of the reward circuitry, with the~     central role of NAc in the pathophysiology of BED and obesity. The recent application and~     effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest~     that DBS may be of interest in treating obesity and BED with potential target for the NAc.~     This project propose to study fMRI activation of the reward system in response to food~     stimuli to better direct the DBS targets. This is a pilot study to define indication~     criteria based on fMRI to obese BED patients are potential candidates for treatment with~     DBS.~   "
14413|NCT02868606|"~     Many hospitals have begun giving insulin to nearly all patients with diabetes while they are~     in the hospital even if a patient does not use insulin at home. Controlling blood sugar with~     insulin when a patient is hospitalized is believed to reduce the risk of complications and~     death, but research has not demonstrated these benefits except in patients who are~     critically ill. The purpose of this study, therefore, is to evaluate whether such insulin~     therapy actually does reduce in-hospital complications, deaths, need for intensive care, or~     length of stay in the hospital.~   "
14414|NCT02868593|"~     The primary purpose of this study is to assess the contribution of a non-invasive sampling~     (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.~   "
14415|NCT02868580|"~     This is a phase 2a open label, multicentre design study to investigate the safety of Triumeq~     in patients with ALS at 24 weeks post treatment. In this phase 2a study the investigators~     aim to determine whether a combination of anti-retroviral therapy, Triumeq (dolutegravir~     50mg, abacavir 600mg, lamivudine 300mg) is tolerated and safe in patients with ALS. As~     secondary outcomes, ALSFRS-R, ALSQOL, physical examination, neurophysical parameters and~     respiratory and muscle function will be evaluated. Blood and urine samples will be stored~     for possible future analysis for viral activity. Subjects will be screened for the study~     after signing an approved Informed consent document.~   "
14416|NCT02868567|"~     This study will comprise an 18-week open label safety and tolerability trial. In this study,~     a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate~     ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be~     obtained. This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of~     this measure was shown in MS studies when compared to the MSWS-12 (12 item walking scale)~     and CGI (clinical global impression) scales (35-37). A consistent responder will be defined~     as improvement in 3 of 4 Timed 25Foot Wwalk while on medication, compared with the baseline~     results while off medication.~   "
14417|NCT02868554|"~     Purpose:~      The objective of this study is to investigate the effects of accelerated Invisalign and~     vibration therapy on rate of orthodontic tooth movement, activation of inflammation~     biomarkers as well as pain levels experienced by orthodontic patients during the initial 12~     weeks of alignment.~      Participants:~      Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency~     Program will be recruited for this study. Patients older than 18 years old will be otherwise~     healthy subjects previously diagnosed with malocclusion.~      Procedures (methods):~      Each patient will be randomly allocated into either a control group or one of two~     intervention groups. Patients within the control group will receive standard Invisalign~     therapy without vibration. Patients within the intervention groups will receive accelerated~     Invisalign therapy with or without vibration. Patients receiving vibration therapy will~     utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30~     Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's~     dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks~     progress visits.~   "
14418|NCT02868541|"~     The objective of this project is to study the prevalence of viruses and bacteria responsible~     for transmissible acute respiratory infections in the respiratory tract of pilgrims~     returning from the trip. The patients included, will be the consultant pilgrims to the~     traveler health center, and before leaving for Hajj. Based on the results obtained in~     previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total~     (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and~     throat (swab) prior to departure for the hajj. In return, patients will be reconvened~     systematic consultation to record medical events potentially encountered during the trip,~     and it will again be performed the same nasal swabs and throat. It will then be performed on~     these samples' return from hajj molecular detection (PCR and RT-PCR) of 35 viruses and~     bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4),~     Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus,~     polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila~     pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples~     return of hajj positive should be cultured for the isolation of the strain. For patients~     positive return, it will be done further research of these 35 viruses and bacteria on~     samples start of hajj, the same method described above. In addition to this systematic~     consultation, and if symptoms return, the pilgrims will be seen in consultation for a~     diagnosis evaluation and therapeutic management.~      This study will shed light on the acquisition of microorganisms respiratory tropism during~     the stay and on the potential risks associated with the circulation of these pathogens after~     the trip.~   "
14419|NCT02868528|"~     With the development of society, more and more aged pregnant women because of various~     reasons, their abnormality rate of egg chromosome was higher than that of young women, then~     the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women~     is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut~     down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy~     termination after the prenatal diagnosis, reduce their pain of body and mind, the~     investigators will carry out this study. This is a prospective randomized controlled study~     of preimplantation genetic screening with Next generation sequencing technology. The embryos~     with more developmental potential and normal chromosomes should be selected. There is no~     related studies in Chinese. Most international research are limited to fluorescence in situ~     hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So~     there is no evidence of the effects of PGS on advanced age women.~      This study is to compare the outcomes between the advanced age women with two methods~     respectively. After blastocyst culture, blastocysts will be transferred in the control~     group. In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast~     biopsy will be performed and chromosome screening with Next generation sequencing（NGS）~     technology, at the same time, the blastocysts will be frozen, then the blastocysts with~     normal chromosome will be thawed and transferred. The investigators expect that, in PGS~     group live birth rate 、cancellation rate and pregnancy rate are higher than in control~     group; abortion rate is lower than that of the control group.~   "
14420|NCT02868515|"~     The objective of this study is to examine the effects of 2 servings of hot cereal per day~     over 2 weeks on digestive health in children that typically eat low fiber diets.~   "
14421|NCT02868502|"~     The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage~     devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with~     postural change from the sitting to supine positions in eyes with open-angle glaucoma.~      Patients will be assigned to the different study groups according to their past ocular~     history. Interventions are similar to all study group and no medical therapy alteration will~     be made.~   "
14422|NCT02868489|"~     The hypothesis is to determine the effect of bacillus coagulans and galactomannans~     (LactoWise®) administration on microbiota of obese patients undergoing sleeve gastrectomy by~     observing standard protocol measurements in patients following sleeve gastrectomy: blood~     markers and weight, in addition incorporating the Gastrointestinal Quality of Life Index~     (GIQLI)~   "
14423|NCT02868476|"~     Clinical and subclinical thyroid disease is usually used to describe patients with mild~     symptoms correlated to hyperthyroid or hypothyroid state. Therapeutic decision for clinical~     and subclinical thyroid dysfunction should be considered individually. But long term outcome~     for treatment of such functional and structural thyroid diseases had not been recorded~     delicately in Taiwan. Further investigations should be observed in the future.The purpose of~     this study is aiming for early prevention and detection the potential risk factors for~     thyroid diseases in Taiwan.~   "
14424|NCT02868463|"~     The purpose of this study is to characterize bladder urinary oxygen tension (BUOT) in women~     whose urinary microbiomes contains at least one anaerobic bacterial species versus women~     whose urinary microbiomes do not contain anaerobes.~   "
14425|NCT02868450|"~     In 2012, a previous work showed that T. whipplei is a common bacterium detected in various~     situations. A large part of the population is therefore exposed to a T. whipplei but there~     is that some people probably with immunological and genetic factors predisposing which~     develop a disease. The association teams with experience in HLA-typing will allow us to~     better identify patients with a risk of chronic complication.~      The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in~     patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple~     disease and/ or, endocarditis and/or encephalitis).~   "
14426|NCT02868437|"~     This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked~     hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following~     curettage for retained product after second trimester abortion. One group of participants~     will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid~     gel while the other group will underwent curettage alone (control group).~   "
14427|NCT02868424|"~     Phase I/II Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment~     Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD)~     Patients~   "
14491|NCT02867592|"~     This phase II trial studies how well cabozantinib-s-malate works in treating younger~     patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not~     respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel~     growth.~   "
14429|NCT02868398|"~     This study monitors the efficacy and safety of Golimumab in maintaining deep remission and~     quality of life in Ulcerative Colitis patients in deep prolonged remission with Infliximab.~     Patients will be followed up for one year and they will be assessed with biochemical tests~     (C-Reactive Protein , Full Blood Count , Faecal Calprotectin),endoscopic evaluation (MAYO~     Score) and finally histologically.~   "
14430|NCT02868385|"~     An open label, randomized controlled trial of single vs. multiple treatments of praziquantel~     in intestinal African schistosomiasis in Côte d'Ivoire~      This study aims to determine the efficacy of repeated (up to four times) praziquantel~     treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the~     traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive~     antigen- and DNA-detection methods.~   "
14431|NCT02868372|"~     The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc~     of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in~     both groups will be followed up during hospital stay and outpatient clinic visits a week and~     a month after cesarean delivery for surgical site complications which will be evaluated by~     the researcher.~   "
14432|NCT02868359|"~     The purpose of this study is to evaluate the effect of pregabalin on patient reported~     outcomes compared with conventional analgesic care in chronic cervical pain patients with~     accompanying upper limb radiating pain (neuropathic component) treated in primary care~     settings under routine clinical practice.~   "
14433|NCT02868346|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of sexually transmitted infections caused by known~     pathogens, close to the reception of Emergency service. In this instance 30% of patients~     have no etiological diagnosis after the POC sexually infection transmitted tests .~      Most sexually transmitted infections can be diagnosed from an anal swab which is not~     routinely performed. In this study, we suggest to test the hypothesis that anal swab in~     addition to the routine genital swab would increase by at least 5% the diagnosis capacity of~     sexually transmitted infections after the POC tests.~   "
14434|NCT02868333|"~     Background: Most children with primary immune deficiency (PID) now reach adulthood. However,~     few studies have evaluated their health status and health related quality of life (HRQoL).~      Objective: To investigate long-term morbidity, the French Reference Center for PIDs~     initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency~     Long-term Cohort). The data collected will be used to assess the physical health condition~     of patients who reached adulthood and the impact on their quality of life.~      Methods: Patients are asked to complete health status questionnaires. A severity score~     (grade1 [mild] to grade 4 [life-threatening]) is assigned to each health condition. The~     HRQoL of patients is compared to age- and sex-matched French normal values using the SF36~     HRQoL questionnaire.~      Capsule summary. This will be the first study of adult survivors of childhood PID describing~     how the burden of health conditions affect their quality of life.~   "
14435|NCT02868320|"~     This study was conducted at the teaching hospital of Misr University for Science &~     Technology. It aimed to examine the use of SMS technology in educating and monitoring~     diabetic patients in Egypt, and assess the impact of educational text messages on their~     glycemic control and self-management behaviors. Participants were randomized into an~     intervention and a control group. Intervention patients received an instruction booklet as~     well as daily educational and weekly reminder messages to better control their diabetes.~     Control patients received the same instruction booklet but no SMS messages. Both group~     patients took an HbA1c test at the beginning and end of the study period and were asked to~     measure their blood glucose once a week and record their readings into a monitoring table~     over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be~     greater among intervention patients at the end of the study. Secondary outcomes included~     blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of~     hospital/ER visits, frequency of blood glucose measurement, among others.~   "
14436|NCT02868307|"~     Quality of life (QoL) measurements have become an important way to evaluate the treatments~     and care provided to patients with schizophrenia. Understanding determinants of QoL in~     schizophrenia is of importance for developing effective interventions that would improve~     patient functional and subjective well-being. A challenge in the interpretation of QoL~     measures, especially in longitudinal studies, is that QoL is self-reported by the patient~     and might be influenced by psychological phenomena such as adaptation to illness. An~     important mediator of this adaptation process is a response shift (RS), which involves~     changing internal standards, values and the conceptualization of QoL. RS can be divided into~     three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization~     (i.e., a change in the importance attributed to component domains constituting QoL) and 3)~     recalibration (i.e., a change in a patient's internal standards of measurements). Patients~     may change their frame of reference, rendering scores from different measurement occasions~     incomparable. An RS is a potential explanation when the QoL of an individual who has~     experienced a serious health event or chronic condition is similar to the QoL of a healthy~     individual. With an RS, the concept of QoL changes over time and cannot be compared~     longitudinally because of changes in internal standards, values, and/or concepts. True~     change may be over- or underestimated when a RS is present, leading to biased estimates of~     the magnitude of change.The objective is to examine whether a response shift, a change in~     the internal standards of a patient, occurs in patients suffering from schizophrenia and in~     their caregivers.~      This is a monocentric and propective design study, with inclusion of patients and caregivers~     on a 12-month period, and a follow up on a 12-month period.~      100 patients with schizophrenia and 100 caregivers~      Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test -~     pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other~     statistical approaches such as confirmatory factorial analysis, multilevel models and CART~     method.~   "
14446|NCT02868177|"~     Given the data on the active ingredients of Valedia, this research aims to evaluate the~     effect of its chronic consumption (24 weeks) in association with some vitamins and trace~     elements on glucose and lipid homeostasis and especially on fasting plasma glucose in~     volunteers with abdominal obesity associated with impaired glucose tolerance or untreated~     type 2 diabetes and hypertriglyceridemia. This clinical study is designed as a pilot study~     in order to estimate the effect of a dietary supplement formula containing Valedia, vitamins~     and trace elements and its variance on several glucose and lipid homeostasis related~     parameters since these data are still unknown for this specific dietary supplement formula.~     Collected data will provide more reliable information which may be used to plan a subsequent~     larger main study.~   "
14478|NCT02867761|"~     The study hypothesis is that symptomatic current and former smokers with spirometric values~     within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC < 80% predicted~     [to guard against restrictive lung disease]) will still derive symptomatic benefit from~     long-acting bronchodilator therapy even though they are excluded from current GOLD guideline~     recommendations.~   "
14492|NCT02867579|"~     Described in the 1970's, pregnancy denial occurs as the un-consciousness of being pregnant~     for several months or throughout the entire period. Body transformations are most of the~     time not clearly noticeable. The prevalence of this symptom could represent 2 or 3 births~     over 1000. The definition of pregnancy denial remains unclear due to the different~     nosological classifications used. There is no international consensus. Encountered~     terminologies are different from on author to another: pregnancy denial, pregnancy negation.~     The difficulties to define properly pregnancy denial accurately reflect the clinic~     heterogeneity of our patients when practicing on a daily basis. As a result, it is difficult~     to find predictive factors: any women of childbearing age, regardless her age, parity or~     social professional category, can be subjected to pregnancy denial. Several publications~     report observations of case of denial of pregnancy, few retrospective studies were realized,~     only two studies were interested in the future of the child, and no prospective study was~     interested in the future of the relation mother - child. The denial of pregnancy questions~     the maternal psychic functioning. No link between psychiatric disorder and denial of~     pregnancy was until then established. Our various clinical meetings, with mothers having~     presented a denial of pregnancy and reporting a difficult personal history with many breaks~     and events susceptibly traumatic, brought us to emit the following hypothesis: an insecure~     attachment of the mother would participate or at least would facilitate in the construction~     of a denial of pregnancy. These mothers would have a difficult access, even impossible for~     the infantile experiences, the essential experiences in the psychic reorganizations of the~     pregnancy that prepare the woman to accept her new functions of mother. The investigators~     hypothesize that the attachment and the development of the child, as well as interactions~     mothers-babies are disturbed when the woman presents a denial of pregnancy.~      The research will compare the maternal functioning in both constituted groups (group denial~     of pregnancy versus groups control), by estimating the type of maternal attachment, without~     omitting to look for a possible psychiatric pathology, and a personality problem at the~     mother.~      From the questioning on the psychodynamic considerations of the denial of pregnancy, and~     also on the future of the dyade mother-baby, the investigators construct a national program~     of clinical research called Attachment and pregnancy denial, with the participation of 13~     centers in France. This research is a prospective cohort examination with main objectives:~     study the impact of the denial of pregnancy on the pattern of attachment of the child, on~     the interactions of dyads mother-child and on the early development of the child with a~     20-month follow-up. It's a multicenter case-control study with 13 centers (Reims,~     Strasbourg, Besançon, Nancy, Toulouse, Amiens, Troyes, Toulon, Limoges, Ile-de-France,~     Lille, Bordeaux, Paris 18ème), to find the maternal risks factors associated to pregnancy~     denial (secondary objectives).~      The main objectives of this study are: (i) studying the relationship between pregnancy~     denial and the attachment pattern of the child; (ii) studying the relationship between~     pregnancy denial and the early interactions of mother-infant dyads; (iii) studying the~     relationship between pregnancy denial and the early development of the child.~      The secondary objectives of this study are: (i) studying the relationship between the~     duration period from the pregnancy announcement to the delivery and the early development of~     a child, including the attachment pattern of a child, the early interactions of~     mother-infant dyads, (ii) looking for the risk factors associated to pregnancy denial,~     including the type of attachment, the existence of a personality disorders and/or a~     psychiatric pathology~   "
14437|NCT02868294|"~     Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by~     fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real~     congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1~     in 10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with~     symptomatology minor to the patients with lethal form during the neonatal period. The main~     symptoms are dominated by fractures and bone deformities, particularly in the lower limbs.~     Bisphosphonate medication is used for over 10 years to reduce the number of fractures.~     However the long-term effects are not known to date, not allowing even to establish proof of~     the benefit risk. Thus unable to process all of these patients and over a long time, these~     drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat~     fractures, treat bone deformities and prevent fractures future. In the long bones of the~     limbs, the only effective techniques are intramedullary nailing. The majority of realized~     nailing nailing are either sliding or telescopic enabling having a reinforced bone of an~     intramedullary osteosynthesis material over its entire length during the period of bone~     growth. It has been shown that the technique of the sliding nailing was inexpensive but~     reliable especially before the age of 5 years. After that age, all are telescopic nailing~     nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in~     France. However, the number of complications relating to its use is important. Thus, there~     are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one~     or more times during growth. A new nail presented at the French orthopedic company in 2005~     and Fassier Duval reported a much lower complication rate because the rate of nail migration~     is only 9%, without opening the knee joint, which is not possible with the highlight of~     Bailey-Dubow.~      It is proposed to conduct a prospective series of 10 nailing the lower extremities with this~     nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a~     series of patients already treated with Bailey-Dubow nails in order to highlight the~     advantages and disadvantages of using of such a nail.~   "
14438|NCT02868281|"~     This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided~     treatment compared with usual care in asthma subjects in China. It is designed to assist~     Chinese subjects and physicians improving adherence to the guidelines through the inclusion~     of the ACT in the patient's asthma management plan. This is a prospective, multicentre,~     cluster-randomized, open-label 24-week study. In this cluster-randomization design, each~     study center, considered as a cluster, will be randomized to either ACT guided treatment~     group or control group (usual care group). For the subjects who are recruited in the ACT~     centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for~     more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20,~     less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less~     than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the~     control centers, they will be treated based on doctor's subjective judgment. Assignment to a~     treatment will not occur, as no treatment intervention is provided for this study. A total~     of 528 asthma subjects are planned in the study. The randomization will be stratified~     according to the Tier of the hospitals (Tier 3 verses Tier 2).~   "
14439|NCT02868268|"~     This proposal sets forth the platform for a Precision Medicine clinical trial through the~     New Approaches to Neuroblastoma Therapy (NANT) consortium. The plan is to utilize NANT's~     established multi-institutional infrastructure and Translational Genomics Research Institute~     GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological~     specimens in relapsed/refractory neuroblastoma (rNB) including those obtained from the bone,~     bone marrow or soft tissue. Our primary aim is to identify subgroups of rNB patients who~     have potentially targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or~     immunologic (tumor-associated macrophage infiltration and/or programmed death ligand [PD-L1]~     expression) biomarkers in rNB. Additional potential novel biomarkers will also be evaluated~     and reported in this cohort of patients.~   "
14440|NCT02868255|"~     project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as~     a new immunotherapy strategy in cancer.~      Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be~     used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal~     Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy~     volunteers.~   "
14441|NCT02868242|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in~     pediatric participants who are undergoing cancer chemotherapy.~   "
14442|NCT02868229|"~     This is a randomized, double-blind, placebo-controlled trial designed to evaluate the~     safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or~     placebo~   "
14443|NCT02868216|"~     Stress, anger and depressed humor can operate as a trigger to an Acute Coronary Syndrome.1~     It is often found in the literature that patients refer excessive anger, anxiety, sadness,~     pain or acute stress promptly before the acute myocardial infarction (AMI) onset, and recent~     meta-analysis report a strong association between the occurrence of AMI and many of these~     acute emotions.2 According to Mostofsky, Maclure, Tofler, Muller and Mittleman3 the risk of~     suffering an AMI doubles after anger burst episodes when compared to another experienced~     situations.~      Anger is a common manifestation of psychological stress,4 and has been considered as an~     hypothesis that this emotion could trigger off an atherogenic process through several~     mechanisms.5-9 Evidences even suggest that hostile people that inhibit their anger~     expression are more prone to develop coronary atherosclerosis.10~      Coronary atherosclerosis features narrowing of coronary arteries on account of endothelial~     thickening caused by the build up of atheromatous plaques.11 It is a process characterized~     by inflammatory and fiberproliferative response of the artery wall, caused by continuous~     aggression to its surface and whose thickening, evoked by the evolution of fat streaks~     atherosclerotic lesions, until fiber plaques is quite slow.12~      Vascular alterations present in atherosclerosis derive from some essential processes:~     endothelial dysfunction, that has an early establishment and alters vase responsiveness,~     leading to vessel constriction,13 coronary blood flood disorders, 13,14 atherosclerosis and~     thrombosis evolution. Endothelial dysfunction also results in the loss of natural~     anti-thrombotic properties involved in the endothelium patency.14~      According to a study performed by our group in the Hemodynamics Sector of the Cardiology~     Institute of Rio Grande do Sul and recently published in the International Journal of~     Cardiology, anger management was significantly lower among patients with CAD when compared~     to those without CAD, and the occurrence of major cardiovascular events (MACE) was~     significantly higher in patients presented with lower anger control. Both associations were~     independent from traditional risk factors, occurrence of previous events or another anger~     aspects.15 Thus, this study was designed in order to evaluate the effect of the cognitive~     training to anger management and control on endothelium-dependent vasodilation of the arm~     artery in patients with acute myocardial infarction with ST segment elevation submitted to~     primary coronary intervention. Secondary objectives comprehend the assessment of the this~     treatment influence on the incidence of recurrent cardiovascular events in these patients.~   "
14444|NCT02868203|"~     This study evaluates the completeness of strut coverage and vessel wall response, at~     different time points (3-6-12 Months), following CordimaxTM stent implantation in patients~     with non-ST elevation acute coronary syndrome~   "
14445|NCT02868190|"~     This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two~     trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle~     glaucoma on one topical hypotensive medication~   "
14493|NCT02867566|"~     The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP~     in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.~   "
14447|NCT02868164|"~     The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary~     Sciences, New Delhi. As a part of this study history will be taken and clinical examination~     will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic~     Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic~     Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which~     is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool~     will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will~     be instilled into proximal small intestine by way of a thin and soft tube inserted through~     nose. This administration of sample, 50 ml daily will occur once a month every month for 6~     months. The liver function parameters will be assessed and thereafter at 1 month and 3~     months & subjects will be clinically assessed for improvement or worsening.~   "
14448|NCT02868151|"~     The surrounding controversies both advocating and simultaneously opposing the use of vitamin~     C, mostly extrapolating animal models to human models, it has not been used individually to~     assess the severity of oral mucositis during chemoradiotherapy.~      The present study is undertaken to evaluate the effect of vitamin C oral supplements in~     assessing the severity of oral mucositis during chemoradiotherapy for oral cancer.~   "
14449|NCT02868138|"~     The aim of this single-center observational study was to evaluate quality of life, clinical~     effectiveness, and satisfaction in pediatric and young adult patients with sickle cell~     disease receiving hydroxyurea.~   "
14450|NCT02868125|"~     There is no standardized protocol regarding the post-operative radiographic follow up of~     patients that sustain pertrochanteric hip fractures and are treated with closed reduction~     and internal fixation. The policy in the investigator's institution as in other hospitals is~     to conduct a radiogram of the operated hip during the first days following operation after~     the patient bore weight on the fixated femur. The investigator's goal is to asses the added~     value of this policy and to offer recommendations regarding this specific followup~     component.~   "
14451|NCT02868112|"~     The purpose of this research study is to pilot test a transdisciplinary intervention that~     integrates both geriatrics and palliative care with routine oncology care for older adults~     with incurable cancer. The investigators will explore their perceptions of the supportive~     care needs of older patients with cancer. Using these data, the investigators will finalize~     the transdisciplinary intervention and perform a pilot, randomized trial of the~     transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed,~     incurable cancer.~   "
14452|NCT02868099|"~     The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut~     subjects with persistent or chronic primary immune thrombocytopenia (ITP).~   "
14453|NCT02868086|"~     The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of~     public health. The therapeutic arsenal has widely grown throughout the years with the~     emergence of intra-vitreous anti-angiogenic treatments, under different surveillance~     protocols. The PRN surveillance (pro re nata: an on-demand treatment with monthly~     follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain~     the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular~     signs of activity. The monitoring is done during common practice via OCT B scans showing~     indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been~     recently enriched with new programs allowing the visualization of sub-retinal neovessels~     without the use dyes (OCT angiography). The OCT angiography is automatically done by a~     program using standard OCT sections. During the monitoring of a patient using the OCT A, the~     signs of renewed neovascular activity are represented by an arterialization or the~     development of an arteriole network of the neovessel with the reappearance of a hyper~     reflective flow after a neovascular regressive phase. Indeed, the visualization of~     neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications~     (anticipation of the injections). Knowing that the injection time-table of ARMD patients~     treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity.~     This activity is evaluated during routine clinical practice by very specific signs,~     observable on OCT B scans. The hypothesis of this study is that the search of activity sins~     on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this~     injection time-table, with an impact of the patient's visual acuity.~   "
14454|NCT02868073|"~     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the~     Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN)~     Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers~   "
14455|NCT02868060|"~     The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in~     patients with immune thrombocytopenia.~   "
14456|NCT02868047|"~     There is tremendous variability in regard to provider perception of findings on EUS for~     chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers~     to determine the validity of minimal standard criteria.~   "
14457|NCT02868034|"~     Research on spinal manipulative therapy for individuals with low back pain has been hampered~     by a lack of understanding of which of the physiologic effects produced by spinal~     manipulation are related to clinical benefit, and how these effects can be used to optimize~     treatment outcomes. Prior research has identified physiologic effects that relate to the~     clinical benefits from spinal manipulation treatment. The goal of this project is to examine~     strategies to use these effects to identify optimized treatment protocols. The results of~     this project will provide critical information for future clinical trials related to spinal~     manipulation.~   "
14458|NCT02868021|"~     This pilot study will investigate the effects of blood flow restriction (BFR) exercise for~     up to 6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure~     clinical outcomes such as strength, lower extremity function, and pain.~   "
14476|NCT02867787|"~     Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of~     the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of~     botulinum toxin are mainly based on its ability to block the neuromuscular transmission by~     preventing the release of acetylcholine, creating paralysis muscle relative and reversible.~      It has been used in the treatment of cervical dystonia, migraine headaches, and an~     antinociceptive effect. The analgesic effect occurred even prior to the release muscular.~     Several randomized studies have been published about it. The investigators assume that~     intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy~     rotator cuff.~   "
14459|NCT02868008|"~     Microsurgical resection for eloquent arteriovenous malformations (AVMs) remains challenging.~     Currently, there are only two grading systems concerning pretreatment assessment of brain~     AVMs: the Spetzler-Martin grading system proposed by Spetzler and Martin in 1986 and the~     supplementary grading system proposed by Lawton in 2010. Controversies exist regarding the~     treatment timing and treatment modalities for eloquent AVMs. Till now, there is no clinical~     trial concerning the efficacy of multimodal magnetic resonance imaging techniques in~     assessing the surgical risk for eloquent AVMs. The investigators assume that multimodal~     imaging-based grading system is superior to the classic Spetzler-Martin grading system and~     the supplementary grading system in predicting the surgical risk for eloquent AVMs.~   "
14460|NCT02867995|"~     The purpose of this study is to determine whether glaucoma drop aids will be cost-effective~     in delivery of ophthalmic medications by improving medication compliance, visual function,~     and even decreasing medication waste in the patient population at Boston Medical Center~   "
14461|NCT02867982|"~     This is a two-year prospective randomized clinical study to to evaluate whether the gingival~     thickness and insertion depth of dental implants have any influence on marginal bone levels~     changes around platform switched implants.~   "
14462|NCT02867969|"~     This is a piloting study using continuous motor training provided via whole body-controlled~     video games (exergames) to establish proof-of-concept evidence that such training leads to~     motor and neural changes in pre-manifest subjects with spinocerebellar ataxias (SCA).~   "
14463|NCT02867956|"~     The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients~     with platinum resistant or refractory ovarian cancer when combined with etoposide.~   "
14464|NCT02867943|"~     As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is~     proportional to CO2 production and inversely related to cardiac output (Fick equation).~     Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because~     of buffering of bicarbonate ions by the protons produced in excess secondary to the~     hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of~     tissue hypoxia.~   "
14465|NCT02867930|"~     The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable~     alternative for moderate sedation in out-patient diagnostic trans-esophageal~     echocardiography.~   "
14466|NCT02867917|"~     The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil~     orange®, Volcolon® and generic orange psyllium.~   "
14467|NCT02867904|"~     The purpose of this study is to assess the efficacy of intra-operative subacromial~     corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of~     life scores and activity level when compared to a control group.~   "
14468|NCT02867891|"~     In this trial the investigators will evaluate the outcomes of 4 pre‐defined groups of~     individuals according to the therapeutic intervention. The investigators will determine the~     outcome of each group by monitoring the survival and the response rates of patients with~     FLT3-ITD AML relapse after allo-HSCT.~   "
14469|NCT02867878|"~     The investigators will randomize patients admitted to hospital with Takotsubo diagnosis to~     systematic high-dose adenosine infusion for 3 minutes (in addition to standard of care) vs.~     standard of care. The primary aim of the study is to demonstrate that adenosine infusion is~     associated with a larger and more rapid recovery of left ventricle function.~   "
14470|NCT02867865|"~     Locally advanced Gall bladders cancers not amenable for curative resection are often treated~     with chemotherapy alone which is the current standard of care. Randomized trials have shown~     survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is~     not common western world and thus there is lack of evidence regarding the impact of~     neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with~     chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo~     R0 resection in few published studies. Also if the patients develop distant metastasis~     during this neoadjuvant therapy they can be spared of unnecessary surgery.~      In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated~     with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability~     rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35~     and 20 months for the patients undergoing R0 resection.~      In this study the investigators intend to compare the effects of using neoadjuvant~     chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall~     bladder cancers in terms of down staging and overall survival.~   "
14471|NCT02867852|"~     Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland~     histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise~     specified) distinguish themselves for the expression of androgen receptors (AR), which is~     reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen~     deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or~     disseminated AR-expressing disease. No other therapy except palliative chemotherapy is~     available after progression on ADT, thus underling the necessity of alternative therapeutic~     approaches.~   "
14472|NCT02867839|"~     The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin~     versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with~     locally advanced gastric cancer.~   "
14473|NCT02867826|"~     The aim of this study is to compare the visualization rates of the ampulla of Vater using~     forward- viewing endoscopes with or without cap attached to the distal end in the same~     patient.~   "
14474|NCT02867813|"~     The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and~     well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease~     (CVD).~   "
14475|NCT02867800|"~     To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when~     added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin~     inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine,~     thiotepa, melphalan, and alemtuzumab for conditioning.~   "
14477|NCT02867774|"~     The purpose of this pilot study is to evaluate the impact of an intervention to increase~     physical activity on pain, function and quality of life in women with chronic pelvic pain.~   "
14479|NCT02867748|"~     Abstract:~      Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the~     quality of life of many female individuals and frequently treated by surgical intervention.~     The incontinence curative operations revolutionized at 1995, with the introduction of the~     first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty~     (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later~     proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries.~      Among other peri-operative complications attributed to the commonly used anti-incontinence~     TOT are the thigh and groin pain. These pains are subjects of concern for patients and~     physicians worldwide. Another, rare yet very disturbing post-operative complication is~     erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was~     claimed to be a predictive sign for future erosion of the polypropylene tape into the~     vaginal cavity.~      This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon~     J&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable~     polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this~     study is to evaluate the feasibility, the safety and the cure rate of both procedures, as~     well as documenting the post-operative immediate, and long term thigh and groin pain levels,~     and dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at~     vaginal examination and the possible relation of this to further vaginal tape exposure.~      Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene~     material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels~     at the short and long term post-operative course, as well as to reduced tape palpability and~     exposure to the vaginal cavity. investigators believe that favorable results for this study~     might improve patients' post-operative quality of life and overall satisfaction.~      Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress~     incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.~   "
14480|NCT02867735|"~     To evaluate the safety and tolerability of LKA651 in patients with macular edema from~     diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal~     vein occlusions (RVO)~   "
14481|NCT02867722|"~     In this study, daylight PDT will be administered to interested patients at~     Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an~     effective and painless alternative to traditional PDT. Daylight PDT involves application of~     the photosensitizer in the physician's office followed by exposure to daylight.~   "
14482|NCT02867709|"~     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25~     and 50 mg) compared to placebo for the acute treatment of a single migraine attack.~   "
14483|NCT02867696|"~     The primary aim of this study is to examine the effect of applying a minimal contact~     technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change~     compared to Standard Care. Forty participants at 1-year post bariatric surgery will be~     randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery).~     Analyses will be conducted to compare these interventions for differences in body weight,~     body composition, fitness, physical activity, engagement, psychosocial measures, and~     intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable~     monitor that provides feedback on energy expenditure and physical activity, electronic~     tracking of dietary intake, and integration of an electronic scale to provide comprehensive~     feedback to the participant on all components of weight management. TECH participants will~     receive a monthly telephone call from the intervention staff to provide guidance on their~     weight management efforts.~   "
14484|NCT02867683|"~     This study evaluates the use of vibrotactile feedback to traditional vestibular treatment~     protocols. Half the patients will have vibrotactile feedback added to their treatment~     protocols while the other half will undergo traditional vestibular treatment without~     vibrotactile feedback.~   "
14485|NCT02867670|"~     TMS is a non-invasive brain stimulation technique, which can be used to change the activity~     of a person's brain cells without needles or surgery. In this study, the invesigators are~     interested in the brain's ability to adapt (also called neuroplasticity) and regain~     language functioning after a stroke—specifically, they want to determine whether how a~     person's brain responds to TMS in the short term can be used to predict how well they will~     recover language abilities in the long term.~   "
14486|NCT02867657|"~     The purpose of the study is to determine whether a five day mindfulness retreat in nature~     can reduce stress and affect the expression of inflammatory and telomeric genetic markers~     among bachelor students at Danish Universities and University Colleges.~      It is the hypothesis that perceived stress is reduced and the expression of genetic markers~     of inflammation is reduced after a five day mindfulness retreat. Secondary, telomerase~     activity may be increased after the mindfulness retreat.~   "
14487|NCT02867644|"~     The hypothesis is to assess the contribution of conversational hypnosis on anxiety of~     patients who undergoing for a preoperative breast tracking and improve their care~   "
14488|NCT02867631|"~     The Postpartum Weight Management Study is a true community-academic collaboration, bringing~     together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith~     Wright from the University of Pennsylvania to address the needs of postpartum moms. The~     project is an innovative intervention to help moms lose weight after the birth of their~     baby. Helping mothers control their weight during pregnancy and beyond can help both mother~     and baby avoid later obesity and cardiovascular disease. Although all women are at risk for~     retaining the weight gained during pregnancy, this problem is amplified for low-income,~     minority women. The holistic approach aims to prevent postpartum weight retention and~     increase breastfeeding duration with a multi-component, low-cost intervention that provides:~     1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a~     baby carrier to combine exercise with infant care, and a pedometer to accurately measure~     exercise at home; 3) Enhanced peer support, including home visits and group classes with~     other mothers; and 4) Task-oriented professional support from nutrition and lactation~     experts, who assist women in developing a personalized health plan. The effectiveness of the~     intervention will be evaluated using a randomized control methodology among clients of MCC.~   "
14489|NCT02867618|"~     This is an open label, phase I/II, dose-escalation study in the initial phase I followed by~     a phase II.~      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and~     dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants~     with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The~     safety and toxicity of this combination will be evaluated throughout the entire study.~      If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is~     established, the phase II part of the study will be initiated.~      Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for~     participants with R/R NHL.~   "
14490|NCT02867605|"~     The purpose of this study is to evaluate whether oral HA35 supplementation changes the~     normal intestinal bacteria, increases intestinal protection, decrease intestinal~     inflammation and permeability, and to assess any health benefits and confirm the safety~     profile of HA35.~   "
14494|NCT02867553|"~     Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A~     quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B~     cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good~     prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous~     recurrences. The radiotherapy is currently the most widely used treatment, with complete~     response rate close to 100% for a lesion treated. However, it has limits when there are~     outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in~     three), or during recurrences. In these situations, conventional chemotherapy is not~     recommended and multi-field radiotherapy is often used empirically, but its effectiveness~     has never been studied prospectively.~      Recently, retrospective studies with small numbers patients (totaling sixty patients)~     reported complete response rates of 80 to 100% with rituximab (anti-cluster of~     differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized~     treatment by intravenous with a recurrence rate of less than one case in three. These data~     suggest that rituximab by intravenous with a standardized initial cycle followed by a~     maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with~     multiple lesions or of recurrent lesions.~   "
14495|NCT02867540|"~     Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80%~     of them will have complications that will require a surgical procedure, usually an~     ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the~     anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at~     least 60% in one year and 80% within three years. The gold standard for monitoring being~     ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to~     12 months after surgery and then every 2 years.~      The MRI enterography is a validated technique for the assessment of small bowel Crohn's~     disease. The enterography MRI is a validated technique for the assessment of small bowel~     Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy,~     with excellent performance in terms of recurrence detection sensitivity and suggested as an~     alternative to it to avoid an invasive procedure repeated in these patients. The MRI~     enterography (without enteroclysis) does not provide as good distension of the bowel loops~     as MRI enteroclysis because it relies on the principle of oral ingestion prior to the~     examination of large amounts of liquid. However, it is much better tolerated by the patient,~     does not involve radiation that exists with enteroclysis, is much simpler to use and~     requires no special equipment to magnetic fields.~   "
14496|NCT02867527|"~     Few publications provide information on the natural history of glaucoma, outside of clinical~     trials do not always reflect what is observed in common situation for various reasons~     (specific selection criteria and sometimes restrictive, stronger motivations patients and~     physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much~     information on the natural history of glaucoma are unknown to date (degradation rate of~     visual field and visual function over time, risk of blindness in the years following~     diagnosis, effects of various treatments to reduce intraocular pressure and preserving~     visual field deterioration, etc.). Obtaining such important data to improve the management~     of glaucoma patients (choice of treatment methods, identification of predictors of rapid~     change that can make choosing more aggressive treatment and more regular monitoring, etc.)~     requires the establishment of cohort of patients followed and treated with the methods~     usually used in current practice, and besides therapeutic trial.~   "
14497|NCT02867514|"~     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial~     Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent~     subjects compared to the application of a placebo tDCS (sham procedure) on the craving,~     which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is~     also evaluated 1 month post-treatment.~   "
14498|NCT02867501|"~     The aim of the study is to assess if venous distension in patients with aneurysmatic~     arteriopathy is higher compared to patients with peripheral arterial occlusive disease~     (PAOD) and in controls.~   "
14499|NCT02867488|"~     The objectives will be to evaluate the dose-response between the amount of soybean oil in~     salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in~     salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and~     beta-carotene.~   "
14500|NCT02867475|"~     Study 1:~      The investigator hypothesizes that the level of knowledge about the benefits of physical~     activity, physical activity level and physical fatigue level observed in cancer patients,~     would influence their beliefs about physical activity and their intention to engage in AP.~   "
14501|NCT02867462|"~     The medical teams are increasingly sought by patients to get the most possible information,~     probably expressed in a different form and thereby supplementing the information already~     received. Coulter et al. reached similar conclusions in their study of the writings of~     patient information documents. They point out, moreover, the best adaptation of the patients~     better informed compared to those with less or no information.~      This need for information varies over time. It is present before treatment begins, continues~     during treatment and persists after treatment. Given the specific features of radiotherapy,~     the manipulators are important interlocutors to participate in the accompanying caregiver~     time.~      In conclusion, the quality of information delivered to the patient has been poorly~     evaluated, let alone with validated tools in this area.~      The impact of information on the tolerance of the treatment also needs to be confirmed,~     knowing that an informed patient seems less anxious and better prepared for future~     treatment.~   "
14502|NCT02867449|"~     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.~     However, the majority of treated patients remain symptomatic. The metacognitive therapy by~     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this~     study is to investigate this approach with a randomized controlled trial by comparing~     metacognitive therapy with exposure and response prevention for obsessive-compulsive~     disorder.~   "
14519|NCT02867228|"~     This study will evaluate the correlation between invasively measured parameters (work of~     breathing/power of breathing, resistance and elastance), derived using esophageal pressure~     measurements, and their corresponding non-invasive estimated values (noninvasive work of~     breathing/power of breathing, resistance and elastance), computed using airway pressure and~     flow measurements only.~   "
14503|NCT02867436|"~     The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in~     children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta~     cell function as compared to age matched controls. Primary objective of the trial is the~     change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT)~     between group on GFD and standard gluten-containing diet.~      Secondary objectives are:~        -  Changes in immune parameters between gluten-free diet group and control group;~        -  Differences in fecal microbiome between children on normal diet and children on GFD;~   "
14504|NCT02867423|"~     The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an~     industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an~     interest in irradiation (boost) of tumor site after conventional irradiation. The radiation~     boost is currently issued by electrons, protons or brachytherapy. These techniques require~     several fractions and are associated with cutaneous toxicities and aesthetic problems. CK~     has an interest in reducing the number of fractions and a reduction of dose delivered to the~     skin.~      CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for~     inoperable breast tumors and has proven its effectiveness and safety of treatments.~      The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays~     issued by CK for boost to the tumor site after conventional breast irradiation.~      The results, in terms of local control, will be evaluated on clinical monitoring.~   "
14505|NCT02867410|"~     Feeding problems are common among babies who are born preterm or who have medical~     conditions. It is not yet known which babies admitted to neonatal units are most at risk of~     feeding problems. Studies have shown that the degree of prematurity and the presence of~     additional health problems make feeding difficulties more likely. However, research does not~     always agree on which health problems are most associated with feeding problems and many~     studies on prematurity exclude babies with the most complex health problems. Additionally,~     not all babies with complex health problems and feeding problems are premature. This study~     aims to answer the question 'Is gestational age or medical status the better indicator of~     risk for feeding difficulties?'~      This research will study babies admitted to the Royal Preston Hospital Neonatal Unit in 2015~     using routinely collected data about stored on BadgerNet, a patient data management system.~     Coded data will be collected for the following variables: gestational age category~     (extremely preterm, very preterm, moderate-late preterm, term), medical status by number and~     type of bodily systems with health issues, and feeding outcome (full oral feeding by 37~     weeks, 40 weeks, before discharge, or discharged home with tube feeding).~      Appropriate statistical tests will be used to determine the presence or absence of~     correlation between gestation age and medical variables and feeding outcome. Information~     from this study will be used to inform neonatal service delivery (including Speech and~     Language Therapy referral criteria and caseload prioritization) and areas in need of further~     research.~   "
14506|NCT02867397|"~     The goal of the current study was to investigate the safety and determine the maximum~     tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with~     advanced or metastatic solid tumors.~   "
14507|NCT02867384|"~     This research study is studying a drug called obinutuzumab as a means of preventing chronic~     Graft vs. Host Disease (cGVHD).~   "
14508|NCT02867371|"~     The Archimedes System is an image-guided navigation system used to access tissue samples in~     the lungs. This study is being conducted to confirm the performance of the Archimedes System~     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung~     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor~     is conducted.~   "
14509|NCT02867358|"~     The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation~     of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains,~     fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.~   "
14510|NCT02867345|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     castration resistant prostate cancer (CRPC). Blood samples will also be collected for~     research purposes.~   "
14511|NCT02867332|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic advanced renal cancer. Blood samples will also be collected for research~     purposes.~   "
14512|NCT02867319|"~     This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide~     vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and~     active surveillance.~   "
14513|NCT02867306|"~     The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the~     pharmacokinetics of once weekly oral methotrexate (MTX).~      This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of~     ASP1707, as well as safety and tolerability of coadministration of ASP1707 and MTX in~     patients with rheumatoid arthritis (RA).~   "
14514|NCT02867293|"~     Massive ascites is usually controlled over several weeks pre-operatively in liver transplant~     recipients with the risk of encephalopathy and peritonitis. We hypothesized that~     intra-operative drainage of ascites will be safe and avoids the inherent risks of~     pre-operative drainage.~   "
14515|NCT02867280|"~     This prospective multicenter non-randomized controlled study evaluates the efficacy and~     safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with~     microvascular invasion after radical resection compared to conventional therapies.~   "
14516|NCT02867267|"~     The purpose of this study is to determine whether thymalfasin is safe and effective in~     patients who have sepsis~   "
14517|NCT02867254|"~     Pulpal and periodontal tissues are closely related and have similar microbiota that~     cross-contamination between the pulp and periodontal tissues.The aim of this study was to~     investigate the prevalence of isolated Candida albicans from periodontal endodontic lesions~     in diabetic and normoglycemic patients and their virulence in different atmospheric~     conditions. A case-control study was conducted on 15 patients with type 2 diabetes mellitus~     (G1) and 15 non-diabetics (G2), with periodontal endodontic lesions. Samples of root canals~     and periodontal pockets were plated on CHROMagar for later identification by polymerase~     chain reaction (PCR) and virulence test.~   "
14518|NCT02867241|"~     The primary goal of this research is to evaluate the effectiveness of an intervention for~     parents to reduce tobacco smoke exposure of young children~   "
14522|NCT02867189|"~     Aims and objectives The purpose of this study was to develop an atlas to explore the effect~     of micro-instrument cleaning on the safety of cataract surgery.~      Background Cataract surgery safety is affected by many factors, the most influential of~     which is the quality of instrument cleaning. Previous studies focused on the reaction in the~     eye after cataract surgery. None offered a solution for manually cleaning ophthalmic~     micro-instruments or response data for surgical instruments after cataract surgery.~      Design The study was designed to collect quantitative data derived from postoperative ocular~     evaluation.~      Methods We developed an atlas that details micro-instrument cleaning that could be used to~     train nurses to have this skill. A total of 120 cataract patients were divided evenly into~     experimental and control groups. In the experimental group, cataract surgery was undertaken~     using microsurgical instruments that were cleaned by the atlas-trained nurses. In the~     control group, micro-instruments were used that had been cleaned by non-atlas-trained~     nurses. All the patients underwent the same postoperative tests: anterior chamber cell~     counts and visual and intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.~   "
14523|NCT02867176|"~     This is a prospective, randomized, single blind study. Patients enrolled in the study were~     randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain~     scores and variables will be evaluated, along with others side effects variables.~   "
14524|NCT02867163|"~     This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in~     total knee replacement patients who received an intraoperative dose of tranexamic acid.~   "
14525|NCT02867150|"~     The purpose of this study is to determine whether red light therapy using LED 635nm red~     light for body contouring of the waist, hips and thighs is as effective as red light therapy~     using Laser 635nm red light.~   "
14526|NCT02867137|"~     The PreTBI I study will investigate whether prehospital blood samples drawn already in the~     ambulance can rule-out intracranial lesions in patients suffering head trauma. The study~     aims to improve triage and treatment of patients suffering mild head trauma, who are~     considered low-risk patients. These patients do not always benefit from hospitalization, but~     are nevertheless admitted on precaution, as clinical assesment can be difficult.~      Hypotheses:~        1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules~          out traumatic intracranial lesion with a sensitivity >97%.~        2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI~          patients rules out traumatic intracranial lesion with sensitivity >97% and results in~          lower false positive rate than S100B.~        3. Prehospital measurements of both GFAP and S100B results in lower false positive rates~          than in-hospital measurements.~   "
14527|NCT02867124|"~     This proposed five-year study will focus on whether the addition of providing XR-NTX~     treatment at a patients' place of residence will increase adherence and thus efficacy of the~     medication.Following initial screening, informed consent, and medical examination,~     pre-release prisoners at each facility will be block randomized (N=240) within gender to~     either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six~     monthly injections post-release in the community at an opioid treatment program; or~     Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly~     injections post-release in the community at the patient's place of residence.~   "
14528|NCT02867111|"~     Infertility is considered a disease by the World Health Organization, and it is increasing~     worldwide, affecting more than 70 million couples. About 50% of the cases are due to male~     inability to fertilize the oocyte. In the last 40 years, several techniques, known as~     Assisted Reproduction Technology (ART) have been developed to treat infertility, but the~     efficiency is still relatively low (around 30% of success) whereas the remaining 70%~     attempts again several times, an expensive and emotionally moving treatment. Over 4million~     of infertility treatments are practiced around the world per year and a 50% increment is~     expected over the next 6years. Even though ART allows the birth of babies that would be~     impossible under natural circumstances, it is still necessary to improve the procedures in~     order to increase treatment efficiency. The success of ART depends, to some extent, on sperm~     quality. Indeed, the relevance of spermatozoa quality is notorious even beyond~     fertilization, extending to embryo development and implantation. In this context, it has~     been developed a new technology that allows the selection of those spermatozoa at their best~     functional state (Sperm Selection Assay, SSA; Patent approved for USA and Europe, pending~     for Japan and Argentina). This method is based on the attraction of spermatozoa ready to~     fertilize the egg, towards a physiological attractant molecule. The SSA may be applied to~     improve diagnosis and infertility treatment. The investigators hypothesis states that the~     use of the SSA will improve the number of good-quality embryos which are the ones to be~     transferred by intracytoplasmic sperm injection (ICSI), providing a healthy embryo~     development. The protocol involves three experimental groups where the SSA will be used or~     not, before performing the ICSI: 1)SSA containing the sperm attractant molecule, 2)SSA~     without the attractant molecule, and 3)without SSA. The patient inclusion criteria involve~     female factors associated to tubal obstruction and/or endometriosis and male factors~     associated to sperm disability. Several outcome parameters will be determined, the~     percentage of fertilization, embryo quality, rate of pregnancy and rate of birth. The study~     will be carried out in the Universitarian Institute of Reproductive Medicine (IUMER) which~     has been recently established in a public hospital depending on the National University of~     Córdoba, offering free high complexity infertility treatment to patients without health~     insurance or economic support~   "
14529|NCT02867098|"~     An open label comparison of concentration of the study medication administered intravenously~     (IV) versus subcutaneously (SC) in healthy volunteers.~   "
14530|NCT02867085|"~     The prospective BoHemE study is designed to evaluate the correlation between bone marrow~     function and skeletal health in elderly patients (>= 60 years) with or without pre-existing~     myelodysplastic syndromes (MDS).~   "
14531|NCT02867072|"~     Appendectomy is the most common surgical procedure performed in emergency surgery. Because~     of lack of consensus about the most appropriate technique, appendectomy is still being~     performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis,~     the investigators aimed to compare the laparoscopic approach and the conventional technique~     in the treatment of acute appendicitis.~   "
14543|NCT02866916|"~     This is a single site, open-label, non-randomized, dose escalation phase I study designed to~     evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a~     synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger~     RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.~      A standard method 3+3 will be used for dose escalation. A maximum of 30 patients will~     complete the dose-escalation phase of the study; 12 additional patients will be included at~     the RP2D in the expansion phase.~   "
14772|NCT02863939|"~     The aim of this study is to test for an early post-stress cardiac output (CO) change by~     impedance cardiography and its relation to the severity and extent of myocardial ischemia~     and angiographic coronary disease in subjects undergoing exercise stress testing using a~     novel cadmium-zinc-telluride (CZT) SPECT camera.~   "
14532|NCT02867059|"~     This is a single-centre, open-label, study using induced blood stage malaria (IBSM)~     infection to characterize the activity of (+)-SJ000557733 or SJ733 for short, against early~     Plasmodium falciparum blood stage infection. The study will be conducted in two cohorts (n=8~     per cohort). The anticipated efficacious dose range is expected to be within a range of 125~     to 600 mg. The dose used in the first cohort was determined on the basis of the safety and~     PK data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and~     will be 150 mg. Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia)~     obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed~     600 mg. Based on the PK from all three cohort from the FIM study, the median estimated dose~     to obtain the target SJ733 AUC of 13,000 (ug hr/L) is 370 mg. The dose of cohort 2 (≤600mg)~     is intended to provide further concentration-response information in the human challenge~     model.~      For Cohort 2 only, a second dose of SJ733 may be administered at peak gametocytaemia to~     assess if SJ733 can reduce gametocytes and subsequent infectivity to mosquitoes (a washout~     of ~15 days post initial SJ733 treatment will be observed). Depending on the data obtained~     from the first two cohorts, there may be a subsequent cohort, with the investigated dose of~     SJ733 to be determined by the Sponsor and Principal Investigator (PI) and endorsed by the~     Safety Review Team. Should this third dose be investigated, a substantial amendment~     including preliminary data from the first two cohorts will be submitted to the HREC for~     approval.~   "
14533|NCT02867046|"~     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment~     of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious~     complication can be developed. Against this backdrop, if there is any difference of~     frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method~     using medial approach and method using lateral approach in anteroposterior view, the result~     can be crucial factor in selecting the approach. In addition, appropriate volume of~     injection will be checked in each approach.~   "
14534|NCT02867033|"~     The purpose of this study is to constitute the French largest Aggressive fibromatosis~     cohort.~   "
14535|NCT02867020|"~     Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone,~     abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in~     hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated.~   "
14536|NCT02867007|"~     The purpose of this study is to characterize the safety, tolerability, and determine the~     maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of~     exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to~     subjects with locally advanced or metastatic solid tumors.~   "
14537|NCT02866994|"~     This randomized comparative effectiveness trial examines the potential psychosocial and~     physical health-related benefits of sharing personal websites with other women with breast~     cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family~     and friends only (PCO condition) in a sample of women with metastatic breast cancer.~   "
14538|NCT02866981|"~     The purpose of this registry is to determine if select patients with CNS metastatic disease~     can be safely observed rather than treated. The investigators hypothesize that there is a~     subset of patients with small asymptomatic CNS mets that do not require treatment, these~     patients can simply be observed and will not have CNS progression.~   "
14539|NCT02866968|"~     The study will be a pilot interventional case series aiming to treat 30 patients with~     Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo~     FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The~     doctor is informed of the procedure on the day of.~   "
14540|NCT02866955|"~     Despite advances in early detection and treatment strategy, about 25 to 40% of patients~     treated for breast cancer develop metastasis.~      Some patients are in a therapeutic impasse situation. It is therefore necessary to consider~     all possible options. The Estramustine showed encouraging results in the treatment of~     metastatic breast cancer.~      Given the clinical data, the answer rate of Estramustine and its impact on progression free~     survival deserve to be studied in earlier clinical situation.~      This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and~     metastates, already treated with aromatase inhibitors and for whom this treatment has~     failed.~   "
14541|NCT02866942|"~     A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently~     been approved by a number of licensing boards and is given by a spray into the nose. In the~     United Kingdom (UK), the vaccine has been demonstrated to be highly effective against~     influenza infection. Further, despite concerns that LAIV can cause wheezing in children~     under age 2 years, the previous SNIFFLE studies have demonstrated it to be safe in children~     over 2 years with mild-moderate asthma.~      The objective of this multicentre study is to further assess the safety of intranasal LAIV~     in children with asthma and recurrent wheeze, including those with severe symptoms.~   "
14542|NCT02866929|"~     Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged~     in the past few years as an appealing alternative for patients and practitioners. In the~     context of a thin biotype, these approaches pose a burden that could precipitate periodontal~     detrimental changes. Therefore, case selection and the implementation of periodontal biotype~     enhancing strategies become a relevant consideration to ensure long-term successful~     treatment outcomes. This study focuses on the biological and clinical value of the use of a~     porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of~     Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of~     Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic~     protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect~     that supports an increase on tooth movement rate. The designs of this randomized controlled~     clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho~     tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho~     tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements~     will capture the clinical phenotype; while the biologic phenotype will be derived from~     evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and~     Interleukin-1RA. The significance and innovative value of this proposal stems from the use~     of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the~     corticotomy. This approach could prove to be effective to further increase the therapeutic~     window that allows accelerating orthodontic treatment and, at the same time, could decrease~     the recession risk in movements of proclination of antero-inferior incisors. Besides, the~     use of a collagen scaffold alone could potentially trigger a comparable orthodontic~     acceleratory outcome that could be evaluated as an alternative to decortication.~   "
14773|NCT02863926|"~     Patients scheduled for below knee amputation (BKA) to receive bone marrow cells (cBMA)~     injected IM in the leg proximal to the BKA in the index limb to prevent ischemic wound~     complications after surgery.~   "
14544|NCT02866903|"~     Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of~     rare primary peritoneal cancers, or more frequently distant extension of digestive cancers~     (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can~     be considered as a distinct oncological entity as its genesis, natural history, and response~     to systematic treatments differ to those of other metastases. The development of PC,~     observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in~     the course of the disease. The prognosis is defined by the possibility of complete~     resection, possibly after neoadjuvant treatment. The benefit provided by the combination of~     cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to~     systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based~     on overall survival in several randomized trials, among which one evaluated oxaliplatin. The~     evaluation of the clinical benefit-risk related to the repeated administration of~     non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in~     patients with PC of colorectal origin is already being investigated by several international~     teams.~      The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with~     this disease. The intraperitoneal rather than intravenous (IV) administration of~     oxaliplatin, in this combination, could increase the response of peritoneal lesions known to~     be relatively insensitive to IV chemotherapy.~   "
14545|NCT02866890|"~     The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural~     changes in design. As these changes may influence the performance of the LTS-D relative to~     the old LTS-D version the investigator decided to check the new LTS-D in the pediatric~     version The investigator hypothesized that the LTS-D perform clinically well during general~     anesthesia with controlled ventilation.~   "
14546|NCT02866877|"~     This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients~     who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development~     of augmented renal clearance and the effects and duration of effects this may have on~     levetiracetam clearance.~   "
14547|NCT02866864|"~     The investigators will evaluate sensitization to animal allergens and allergic symptom~     during contacting animal allergens in Korean veterinary researchers who attend their annual~     conference.~      The investigators will compare sensitization to animal allergen and other clinical and~     occupational factors between subjects who suffer from allergic symptom during contacting~     animal and those who do not.~   "
14548|NCT02866851|"~     Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥~     20%. The use of the web-application their will be proposed .~      They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond~     the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).~      The temperature measurement is performed at home by an infrared forehead thermometer~     provided as part of the study, in a systematic manner once daily at the same time of day and~     in case of unexplained fatigue or chills.~      Before any fever reported to the physician via the web-application (alert), a questionnaire~     will be completed by the patient to the search for gravity criteria to assess his condition~     at home. The patient will be hospitalized immediately if it shows signs of severity in order~     to document the infection and provide intravenous antibiotics adapted to the clinical~     condition; in the absence of these signs, the patient will make a count to the nearest lab~     and will receive oral antibiotics if indicated. The subsequent strategy will be defined by~     the web-application algorithm to optimize the care of patients.~      The ability to use a web-application could allow early detection of complications of~     post-chemotherapy haematological toxicity and offer a taking over guided by a~     decision-making algorithm managed by the physician.~      The aim is to favour the taking over at home.~   "
14549|NCT02866838|"~     Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the~     coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors~     apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of~     NOAC treatment (NOAC-ICH).~      Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There~     is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable~     outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of~     bleeding conditions other than ICH.~   "
14550|NCT02866825|"~     The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the~     trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal~     antibody IFX-1 in these patients. In addition, this trial further aims to characterize the~     safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on~     clinical surrogate endpoints.~   "
14551|NCT02866812|"~     During the last decade, the embolization has become the treatment of choice for ruptured~     intracranial aneurysms, to improve the neurological outcome of patients. At the same time,~     for his safety, she also became the technique allowing prophylactic treatment of unruptured~     intracranial aneurysms discovered incidentally during imaging exams.~      Regarding patients with ruptured intracranial aneurysms, patients who survive often have a~     reduced quality of life while one in two has a good neurological outcome after embolization.~     Depression, anxiety and fatigue, whose the psycho-social impact is important, are often~     cited. This description has often been done without considering the realized type of~     treatment (surgery or embolization) and mostly of neurological and functional status of the~     patient remotely (disability or not in daily activities).~      Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and~     embolization is programmed. They would present an cognitive impairment in one case in five~     at 1 month of treatment.~      If depression, fatigue and difficult return to working life are logically found in patients~     with severe sequelae (disability in daily activities) of their ruptured intracranial~     aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a~     favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.~      A precise status of these populations is necessary, especially as the discovery and~     treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that~     their good neurological status should allow a priori to return easily at the active life.~   "
14552|NCT02866799|"~     This study assesses the effectiveness of a complex intervention in young-old patients with~     multimorbidity and polypharmacy aimed at improving physician drug prescription in primary~     care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1)~     and 12 (T2) months from baseline compared to usual care.~   "
14553|NCT02866786|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of~     reproductive age and is a leading cause of infertility due to anovulation. Oral~     contraceptive pills (OCPs) are considered as first line medical therapy to regularize menses~     in woman with PCOS. However they may worsen the metabolic profile of patients by elevating~     insulin resistance which is already deranged in PCOS. As there is higher prevalence of~     insulin resistance in Indian women with PCOS, insulin sensitisers like metformin may be more~     beneficial. Hence this study is undertaken to compare the combined effect of metformin and~     OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in~     patients with PCOS and to evaluate whether this combination of drugs is more advantageous~     than OCPs or metformin alone in improving the clinical and metabolic profile.~   "
14554|NCT02866773|"~     In Hong Kong, nearly 40% of adults were overweight or obese, and about 60% of total~     registered deaths were due to four major preventable non-communicable diseases. Many~     residents are lack of attention to personal healthy lifestyle and family holistic health.~     This project focuses particularly on the promotion of healthy diet and physical activities~     enhancement in families through the well-established community network of the Hong Kong~     Island Women Association (HKIWA). This project includes three major components:~     Train-the-trainer and -ambassador workshop, community-based family interventions, and public~     education events. It is expected that knowledge and skills of the community leaders and~     ambassadors are strengthened through the 'Train-the-trainer and -ambassador' (TTTA)~     workshops. Furthermore, they are expected to help the implementation of community-based~     family interventions and public education events on the personal and family holistic health~     of the community participants.~   "
14555|NCT02866760|"~     This study aims at understanding the needs and concerns of Chinese current smoking patients,~     including their risk perceptions, and the behavior, attitudes, and experiences related to~     smoking and smoking cessation. Specifically, how smokers overcome withdrawal symptoms and~     cigarette cravings, as a result of banning on smoking in hospitals, will be explored. In~     addition, whether smokers will stop, resume or continue smoking after hospitalization will~     be investigated.~   "
14556|NCT02866747|"~     This study is a phase I/II, national, multicenter, open-label study starting with a Phase I~     part followed by a Phase II part.~      The phase I part of the study aims to evaluate the safety of the association of~     hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab~     immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will~     be enrolled in this phase I part.~      Once the recommended combination schema will be declared, patients will be enrolled in the~     Phase II part of the study in order to evaluate the efficacy (local control rate) of the~     combined treatment in recurrent glioblastoma. In this Phase II part, patients will be~     assigned by randomization to one of the two following arms:~        -  Arm A (control arm): Radiation therapy alone (17 patients)~        -  Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab (33 patients)~   "
14557|NCT02866734|"~     Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic~     retinopathy (DR) is one of the most common complications of DM. Screening for DR is a~     cost-effective method to identify patients who are at risk of vision loss so that timely~     treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set~     up screening services (RAMP) in the government outpatient clinics and all DM patients~     attending these clinics will be screened at least once every two years and some every six~     months, according to their individual risks. However, those diabetic patients who attend the~     private sector for their primary care may not have access to this service.~      Aim: This study from the University of Hong Kong aims to determine the characteristics of a~     sustainable approach to setting up an effective and quality-controlled screening service for~     DR in the private primary care sector of Hong Kong and to estimate the potential benefit to~     be gained in terms of impact on avoidable vision loss, costs of care and potential for~     further development of this model in chronic disease care.~      Methods:A screening centre is being set up and a randomised study carried out in which~     screening will be offered at three different fee levels to subjects recruited by their~     general practitioner (GP). The following data will be collected (a) willingness to attend~     screening at the different fee levels (b) screening findings in terms of DR and other eye~     diseases (c) risk factors and other characteristics of those screened and unscreened. The~     information will allow us to estimate the level of fee which best combines effectiveness~     with sustainability in the longer term.~   "
14558|NCT02866721|"~     This study is being done to test if it is safe to give stem cells to adult patients with~     Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human~     mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different~     types of cells and respond to various environmental situations. Allogeneic means the cells~     come from another person (a donor).~      This study is only looking at whether or not it is safe to give the stem cells to adults~     with CF and how the infusion is tolerated. In the future, other studies may be done to see~     if stem cells can be a new therapeutic treatment for CF.~      Stem cells, like other medical products that are intended to treat, cure or prevent disease,~     generally require approval from the U.S. Food and Drug Administration (FDA) before they can~     be marketed. The FDA has not approved any stem cell-based products for usual medical care,~     other than some specific blood forming stem cells for certain indications.~   "
14565|NCT02866630|"~     In the last few years, anaesthetics gas such as isoflurane, desflurane and sevoflurane used~     in heart surgery have shown some benefits to reduce the risk of heart muscle damage than~     total intravenous anesthetics. A study by the investigators suggested that isoflurane needs~     a longer duration to achieve equilibrium between coronary sinus and radial artery,~     indicating that isoflurane in coronary sinus does not accurately reflect its level in the~     heart muscle. Different agents have unique characteristics with different equilibration~     rate. However, the levels of sevoflurane and desflurane in coronary sinus and radial artery~     have not been measured. In addition, lactate is believed to be a very useful indicator to~     predict the outcome of recovery phase after any surgery. This study aims to measure the~     level of sevoflurane or desflurane in blood circulation. It will also assess whether~     sevoflurane or desflurane concentration in the blood is correlated to the its oxygenator~     exhaust level and affected by temperature, haematocrit level and gas flow rate during~     heart-lung machine. It also aims to examine the association of lactate and the outcomes of~     cardiac patient in intensive care unit after cardiac surgery.~   "
14559|NCT02866708|"~     This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue~     perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot~     study will look at the effects of intermittent negative pressure (INP) therapy wound healing~     and the peripheral macro- and microcirculation in spinal cord injured patients with chronic~     leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized~     clinical trial with single-subject multiple baseline design. We will perform convenience~     sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment~     by the end of december 2016.To ensure equal distribution of participants in each study arm,~     we will perform block randomization. A statistician will randomized patients to either~     intervention arm or control arm before start of the study: At baseline, each participants~     will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP~     therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in~     the the control group (A) will be re-examined, and start 8-week INP therapy. Also the~     intervention (INP) will be subjected to the same lower limb in each individual throughout~     the study period. The other leg will act as a intra-individual control.~      At baseline (week 0), and during the course of the study (every 4th week), the participants'~     wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after~     intervention the following measures will be performed: Demographic data (weight, height,~     ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser~     Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and~     health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be~     examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx~     devices and provided the necessary training to perform this project. Outcome variables~     assessed before and after the study period will be: wound healing (primary endpoint),~     quality of life (secondary endpoint), skin perfusion pressure (secondary endpoint),~     ankle-brachial pressure (secondary endpoint) and segmental pulse-volume recording (secondary~     endpoint). The aim of this project is to prospectively examine and elucidate the effect of~     intermittent negative pressure therapy applied to a limited part of the lower limb on~     clinically relevant measures related to wound healing and peripheral macro- and~     microcirculation in patients with spinal cord injury.~      The hypothesis of the study is:~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve wound healing in the foot compared to before treatment (baseline).~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve macro- and microcirculation in the foot compared to before~          treatment (baseline) in patients with spinal cord injury.~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve macro- and microcirculation in the intervention foot compared to~          the control foot in patients with spinal cord injury.~   "
14560|NCT02866695|"~     This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid~     organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney~     transplant recipients and 10 lung transplant recipients. The investigators have selected~     these two populations as the represent the spectrum of solid organ transplantation: kidney~     transplant recipients are the largest transplant population, but have lower levels of~     immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden~     of skin cancer and actinic keratoses.~   "
14561|NCT02866682|"~     As the patents for brand-name immunosuppressive medications expire, there is increasing~     interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies~     showing bioequivalence, questions remain regarding the clinical impact of use of generic~     immunosuppression.~      The most important immunosuppressive agent in the modern transplant era is arguably~     tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to~     answer the question regarding the clinical impact of generic tacrolimus use as measured~     primarily by acute rejection, loss of graft function, and patient death through a randomized~     trial of 4 parallel groups: Brand tacrolimus only, brand tacrolimus for 6 months than switch~     to Generic A, Generic A only, or Generic A for 6 months than switch to any other generic~     tacrolimus. Given that kidney, liver, and heart transplantation are the most commonly~     performed transplants with well-defined measures of rejection and graft failure, these~     organs will be studied in a two-center study designed to accrue the target number of~     transplant recipients within the three-year study period.~   "
14562|NCT02866669|"~     The central objective of this proposal is to rigorously compare two strategies designed to~     improve BP control in primary care practices serving rural Southeastern African Americans~     with low socioeconomic status (SES) living in the Black Belt.~      The Agency for Healthcare Research and Quality (AHRQ) Disparities Report identifies~     individuals with rural residence, minority ethnicity, and low SES as being at high risk for~     poor health outcomes. The Black Belt region stretches from eastern Texas in an arc to~     Maryland and includes residents with all 3 of these characteristics - the proverbial triple~     threat. This traditionally agricultural region is characterized by steep poverty, low~     educational attainment, scarce resources, and mostly African American residents. The Black~     Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the~     highest cardiovascular disease (CVD) mortality in the US. The AHRQ Disparities Report also~     cites that the Southeast has lower quality of care than the rest of the US, thus effective~     strategies to optimize CVD prevention in general and hypertension (HTN) control specifically~     are urgently needed here.~      In year 1 (AIM 1) we're engaging community members (community members who have experience~     being community peer advisors or have high blood pressure) to develop the study~     interventions and protocols. In years 2-5, the investigators will test these interventions.~   "
14563|NCT02866656|"~     In the present study, by evaluating the efficacy and safety of low intensity ultrasonic on~     ASO, to explore the noninvasive auxiliary treatment of ASO. 90 patients were randomly~     divided into 2 groups: A)control group, patients were given Conventional conservative~     treatment; B）treatment group, patients were given Conventional conservative treatment and~     low intensity ultrasonic treatment ; Treatments last for 4 weeks, three times a week,~     stimulation was given 8 minutes every time, location of treatment were lower limb ischemia~     area and its surrounding tissues; outcome indicators were recorded Before and 4 weeks after~     the trial, The Walking Impairment Questionnaire (WIQ), ankle brachial ratio, the farthest~     distance Walking, percutaneous tissue oxygen tension, tissue oxygenation index recovery~     time, local skin temperature, ultrasonic blood vessels, and muscle enzymes, hepatic and~     kidney function.~   "
14564|NCT02866643|"~     A barrier to initiating progestin contraceptives in the early postpartum period is the~     concern of interference with breastfeeding, specifically lactogenesis. In this trial, the~     investigators aim to add to safety data on the effects of immediate insertion of the~     contraceptive implant on breastfeeding. The investigators seek to examine the time to~     lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a~     contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82~     consenting women will be randomized to immediate implant insertion (0-2 hours following~     delivery) in the delivery room or insertion of the implant following delivery in postpartum~     room and prior to medical discharge (24-48 hours following delivery).~   "
14566|NCT02866617|"~     In dentistry, 3D printing technology is gaining interest. One of the potential application~     is to construct appliances on 3D reconstructed study models.~      The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers~     (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models~     by assessing the oral health-related quality of life (OHRQoL) instrument, Little's~     Irregularity Index (LII) and compliance.~   "
14567|NCT02866604|"~     The main objective of this study is to compare the clinical outcomes of TBI patients~     receiving only Sterofundin or 0.9% saline as main fluid therapy.~   "
14568|NCT02866591|"~     Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local~     cancer breast.~      It is sometimes poorly tolerated by some patients who complain of an uncomfortable~     examination or pain.~      Breast compression by the manipulator aims to reduce the thickness of the breast during~     mammography; This act is an important factor of pain or discomfort felt by the patient. But,~     it is also an image quality factor.~      This study aimed to compare self-breast compression by the patient to the compression~     standard technique carried out by the manipulator.~   "
14569|NCT02866578|"~     Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative~     respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly~     increase the peri-operative morbidity and require invasive treatments during longer and more~     expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related~     factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary~     atelectasis seems to play a central role in the occurence of these PPCs. The open lung~     approach is a ventilation strategy that aims to open the lung and keep it open using~     different ventilatory settings. The efficacy of that strategy is not demonstrated in the~     global surgical population. However, its application in the perioperative care of cardiac~     surgery patients could be of great interest by counteracting the development of atelectasis.~      The purpose of this multicentre, double blinded, randomized controlled study is to evaluate~     the influence of a perioperative multimodal protective ventilation strategy based on the~     open lung approach on postoperative outcomes during the first 7 days following cardiac~     surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump~     cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive~     end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of~     ultraprotective ventilation during CPB. It will be compared to a conventional approach~     without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary~     endpoint is any post-operative pulmonary complication. The secondary endpoints are any~     post-operative extra-pulmonary complications and the number of ICU-free days to day 7.~   "
14570|NCT02866565|"~     Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization~     among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and~     precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past~     decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors,~     healing rates of DFU remain low.~      Mechanisms of faulty wound healing in diabetic patients are complex, related to both~     intrinsic and extrinsic factors. The main reasons for impaired healing appears to be:~     1/exhaustion of local cell populations that promote wound healing; 2/excessive production of~     matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of~     MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor~     cells and impairment of their functioning. These imbalances may result in excessive~     degradation of extracellular matrix components, as well as an inappropriate local~     inflammatory response .~      Adipose-derived stroma vascular fraction provides a rich and easily accessible source of~     autologous cells for regenerative medicine applications. Il contains multipotent stem cells~     and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound~     healing. There are attracted to the wound site where they supplement the wound bed with~     similar cell types, secrete numerous growth factors and cytokines, increase macrophage~     recruitment, enhance granulation tissue, and improve vascularisation . The reparative~     capabilities coupled with good safety of ADRCs have been illustrated in a study for treating~     severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly~     in patients with diffuse scleroderma. Numerous case reports showing healing of refractory~     wounds following treatment with autologous ADRCs have also been reported.~      Based on these previous reports, the present study aims to assess the efficacy and tolerance~     of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.~   "
14571|NCT02866552|"~     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an~     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are~     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a~     result, patients suffer from everyday disability, with consequences on their occupational~     activities and social contact, sometimes severely altering their quality of life. To date,~     no anti-fibrosis treatment has proven effective; existing vasodilation treatments are~     unfortunately not very effective, and are associated with adverse effects or restrictions.~     It is consequently of utmost importance that an effective treatment for sclerodermic hands~     be developed. The injection of adipose autologous tissue is a common practice in plastic~     surgery, and has been known for over a century. Adipose tissue, originally used to increase~     volume, is also characterized by trophic properties associated to stromal vascular fraction~     (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some~     SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.~     The injection of SVF into the fingers would also make it possible to control the production~     of the extracellular matrix and to improve the balance between fibrosis and fibrolysis,~     resulting in an improvement of cutaneous sclerosis~      The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients~     suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison~     to the control group.~   "
14572|NCT02866539|"~     The aim of the study is to control blood sugar with Sugar Balance capsules which is the~     leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea~     spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.~   "
14573|NCT02866526|"~     Severe haemophilia is a rare disease characterized by spontaneous bleedings from early~     childhood, which may lead to various complications especially in joints. Due to advances in~     medical care and more specifically in the development of prophylactic strategies by the~     application of clotting factor concentrates, life expectancy of persons with severe~     haemophilia has significantly increased over the last decades. This progress requires a~     long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up~     and to a prophylactic treatment then depends on how successful patients' transition from~     childhood to adulthood has been as this process involves a transfer of responsibility from~     parents to patients concerning the management of their health. Beyond the issue of patients'~     adherence, a suboptimal transition may also impair quality of life and the entry into~     adulthood, especially at the social, emotional and professional levels. Only a few studies~     have been conducted to identify the specific needs and difficulties young persons with~     severe haemophilia experience during their transition from childhood to adulthood, and none~     of these studies has been carried out in France where the features of the health care system~     are very specific.~      Therefore, this study aims to address the issue of transition into adulthood among young~     persons with severe haemophilia in France. This study will focus not only on the~     facilitators and barriers of the access to health care but also, from a more global~     perspective, on all the specific concerns and difficulties they may experience as they grow~     into adulthood which may impair their long-term health related quality of life as well as~     their personal empowerment. This study will also allow to identify some of the socio-~     cognitive, emotional, and familial determinants of a good transition into adulthood.~   "
14620|NCT02865915|"~     This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of 3~     doses of MLE4901 versus placebo in women with PCOS.~   "
14774|NCT02863913|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic advanced bladder cancer. Blood samples will also be collected for research~     purposes.~   "
14574|NCT02866513|"~     Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury~     (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of~     VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes~     like APRV could generate high levels of transpulmonary pressure.~      The aim of this study is to evaluate the variations of transpulmonary pressure during the~     use of APRV by clinicians~   "
14575|NCT02866500|"~     Context: the oral cancer is the 5th cancer in order of frequency for human in France. It is~     the country where the mortality by oral cancer is the most raised in Europe. The most~     frequent location concerns the oral cavity prevalency of which is one of higher in the~     world. The main risk factors are the tobacco and the alcohol.~      The oral cancer is treated in the great majority of the cases by radiotherapy which is going~     to pull xerostomy, responsible for the degradation of the oral state. Furthermore, it will~     increase the risk of appearance of osteoradionecrosis (ORN) when the patient is carrier of~     buccal lesions and\or when he will have to undergo surgical acts. Consequently, the initial~     oral state of the patients is to be estimated so as to eliminate any source of the~     infection. An unfavourable initial state will increase the risk of degradation of this one~     and appearance of ORN. However, at present few epidemiological data are available concerning~     the oral state of the patients presenting an oral cancer.~      Objective: the main objective of this study is to describe, before radiotherapy, the oral~     state of the patients presenting an oral cancer and to follow the evolution of this oral~     state for three years and to register the patients quality of life. The secondary objectives~     are to describe the distribution of risk factors of the degradation of the oral state (oral~     hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and~     to register the impact of the dental restorations on the radiological assessment.~      Methods: this prospective epidemiological study of observation will be realized in the~     service of odontology of the Timone hospital (Marseille, France) in association with the~     services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy~     and medical oncology of Timone and Paoli Calmettes institute (IPC). All the toothed patients~     affected by an oral cancer untreated will be included, or treated surgically only, of more~     than 18 years old and for whom an initial dental assessment will be realized. The main~     assessment criteria will be the CAD index and the parodontal state.~      Expected results and perspectives: This study will allow to have epidemiological data~     concerning patients' oral state affected by an oral cancer before and after radiotherapy. It~     will allow to set up a consensus of good practice.~   "
14576|NCT02866487|"~     The pattern of lower airway inflammation in asthma is heterogeneous, but in many patients,~     the polymorphonuclear neutrophil (PMN) is the predominant granulocyte infiltrating the~     airspaces. Although it is known to have an important function in innate immune defense, the~     role of the PMN in asthma has not been well elucidated. In work in progress, the~     investigators have identified the receptor for IL-5 on the surface of bronchoalveolar lavage~     (BAL) PMNs in a subset of children with severe, treatment-resistant asthma, a characteristic~     that is not found in peripheral blood neutrophils. While the function of this IL-5 receptor~     has yet to be determined, preliminary evidence strongly supports a mechanism linking~     neutrophilic with type 2 inflammation in the lower airways of children with asthma, a~     discovery that has exciting potential to modify the treatment of asthma.~      The primary objective of this observational cross-sectional study is to test the overall~     hypothesis that therapeutic intervention directed against the IL-5R on lung PMNs will~     decrease inflammation and improve clinical outcomes in patients with poorly controlled~     asthma. The secondary study objective is to demonstrate that IL-5R expression on~     lung-infiltrating PMNs is functional, will activate known IL-5R-induced signaling pathways,~     and will lead to enhanced PMN pro-inflammatory activity including increased PMN recruitment,~     prolonged survival, degranulation, and release of reactive oxygen species.~   "
14577|NCT02866474|"~     Malnutrition particularly affects people who delegate the preparation of their meals with~     46% of persons living at home and using a meals-on-wheels service, or those in old people's~     homes (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of~     malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in~     independent persons (Aupalesens Survey). This proportion, which is particularly high, is~     essentially due to the absence or insufficient level of individual monitoring of the~     nutritional status of these dependent populations despite the different recommendations.~     EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and~     gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data~     collection in 2012); in parallel, few professionals are really trained in the needs of the~     elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional~     follow-up is proposed (Guide 2012).~      Symmetrically, the constant search to control costs in western healthcare systems has led~     managers to systematically reduce care costs, in particular those that are not directly~     related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In~     the collective catering services, there is, for example, a systematic effort to reduce daily~     costs/materials, without measuring the global cost related to the efficacy of care.~      The present work is part of the RENESSENS project: these studies will be conducted in two~     elderly populations, one living at home and receiving meals on wheels daily and a regular~     visit of a dietician, who will propose individual nutritional follow-up and the second~     living in an old people's home (EHPAD) that will benefit from the improved management of its~     catering service (good culinary practices, including specific training for personnel and~     meals adapted to the needs of residents). The principal aim of these two studies will be~     common and will be to evaluate the efficacy of this specific type of management of meals and~     nutrition compared with a reference meals-on-wheels service and a reference EHPAD.~   "
14578|NCT02866461|"~     This study is designed to study brain mechanisms associated with symptoms and severity of~     Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported~     and objective measures of disease severity.~   "
14579|NCT02866448|"~     The purpose of this study is to investigate the effect of acute isoquercetin~     supplementation, aspirin, and isoquercetin/aspirin combination on platelet aggregation,~     blood pressure and vasculat stiffness (eg digital volume pulse), as well as investigating~     the plasma accumulation and urine excretion profiles of quercetin.~   "
14580|NCT02866435|"~     The purpose of this study is to investigate how the brain responds to low blood glucose in~     non-diabetic individuals. The ultimate goal is to understand the brain substrates of~     hypoglycemia unawareness, a condition that can occur in patients with type1 diabetes~     undergoing insulin treatment.In the present study, the investigators focus on differences~     between two groups of non-diabetic subjects: one group who experienced two episodes of~     hypoglycemia the day prior to the study (and supposedly developed some level of unawareness~     to hypoglycemia), and one group who did not. In this study, a 3 tesla MRI scanner is used to~     acquire brain images. The imaging system is identical to the ones used in hospitals.~   "
14581|NCT02866422|"~     To support the discovery of new means for revealing the presence of Obsessive Compulsive~     Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to~     automate existing diagnostic procedures allowing for more efficient diagnostic methods that~     would broaden clinical scope and outreach.~   "
14582|NCT02866409|"~     This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to~     local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control~     post craniotomy pain.A third group where patients were administered bupivacaine only~     infiltration has also been created.~   "
14737|NCT02864394|"~     The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus~     docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death~     ligand 1 (PD-L1) positive tumors who have experienced disease progression after~     platinum-containing systemic therapy. The primary hypothesis of this study is that~     pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS)~     compared to docetaxel in participants with PD-L1 positive tumors~   "
14583|NCT02866396|"~     Spinal surgery is associated with intense pain and associated to a history of preoperative~     chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when~     high dose of opioid are required. Preoperative pain is associated with high postoperative~     pain scores and opioid requirement promoting persistent hyperalgesic state. The~     investigators will evaluate the postoperative opioid consumption and pain scores in patients~     scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with~     preoperative pregabalin-free patient that will receive pregabalin only during surgery.~   "
14584|NCT02866383|"~     This is a prospective, randomized, open-label phase 2 study in patients with metastatic PC~     refractory or intolerant to at least one line of prior systemic chemotherapy with~     gemcitabine or platinum-containing regimens to determine the efficacy and safety of~     nivolumab or nivolumab plus ipilimumab administered concurrently with high dose RT. Patients~     with metastatic PC who are feasible candidates for radiation and biopsy of primary and/or~     metastatic lesions will be included.~   "
14585|NCT02866370|"~     The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30~     with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and~     Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis~     must be histologically confirmed and central pathological review of the presenting tumour or~     biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous~     differentiation~   "
14586|NCT02866357|"~     To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute~     exacerbation of COPD and asthma who required hospitalization.~      To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.~      To assess if the infective aetiologies have associations with the clinical outcome of the~     patients.~   "
14587|NCT02866344|"~     This single-center, prospective, randomized clinical trial is designed to compare the~     clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to~     determine the optimal operative intervention for the local treatment of resectable~     colorectal cancer liver metastases. The primary aim of this study is to test the following~     hypothesis: 2-year local disease control is equivalent between patients receiving the~     experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection)~     as treatment for colorectal cancer liver metastases determined to be resectable by~     radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic~     (regional) and metastatic disease recurrence rates are equivalent between the two treatment~     arms in this study.~   "
14588|NCT02866331|"~     This study is performed to reveal the safety and feasibility of combination therapy with~     autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of~     G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1)~     Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test~     (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic~     factors/anti-inflammatory cytokines.~   "
14589|NCT02866318|"~     This retrospective, cross-sectional cohort study was conducted to investigate the novice~     practitioners' learning curve of visual estimation of LV ejection fraction (%) through a~     echocardiographic video files at the academic emergency department (ED) in tertiary urban~     hospital.~   "
14590|NCT02866305|"~     Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous~     pneumothorax in young adults is very limited, and treatment has also been controversial.The~     Aim of this study is to optimize the treatment, estimate the actual incidence, and identify~     possible risk factors including genetic predispositions.~   "
14591|NCT02866292|"~     This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and~     non-pregnant nulliparous women and to correlate with their sexual function and b) to compare~     PFM strength and sexual function between women in the second and third pregnancy trimesters.~   "
14592|NCT02866279|"~     The investigators goal is to measure the impact of timing of postpartum contraceptive~     implant insertion on breastfeeding success and duration and to explore women's experiences~     with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time~     period~   "
14593|NCT02866266|"~     Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency~     Department visits and hospitalizations for overdose/poisoning and death among patients~     prescribed ER/LA opioid analgesics.~   "
14594|NCT02866253|"~     The purpose of this study is to compare the effect of pre-IVF cycles treatment with and~     without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes~     obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve)~     patients and the expression of BMP-15(bone morphogenetic protein 15),GDF-9（growth~     differentiation factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.~   "
14595|NCT02866240|"~     This is a single site, non-randomized, prospective, open-label, interventional~     pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical~     epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure~     onsets originating from the lateral cortical surface of any lobe. Patients will be recruited~     from the epilepsy clinics of Boston Children's Hospital (BCH) and Beth Israel Deaconess~     Medical Center (BIDMC), the home institutions of the principal investigators. All patients~     and referring physicians will be requested to maintain their current antiepileptic drugs~     throughout the study with changes after enrollment permitted only to maintain pre-enrollment~     drug levels, or if clinically necessary. The primary outcome measure will be the change in~     seizure frequency (seizures/4-week period) as compared to baseline. Secondary outcome~     measures include change in interictal discharge burden, change in cortical excitability, and~     quality of life measures.~      Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS~     administered to the seizure focus for 10 sessions over a 2-week period with the allowance of~     make-up sessions in week three. Subjects will be evaluated at baseline, during the~     stimulation sessions, and 4 and 8 weeks after the completion of the tDCS visits~   "
14596|NCT02866227|"~     This is a Phase II study designed to assess the safety and efficacy of an investigational~     product, TOL-463, to treat vaginitis.~   "
14597|NCT02866214|"~     The Purpose of this study is to determine if the Febuxostat has an effect on endothelial~     dysfunction on hemodialysis patients.~   "
14598|NCT02866201|"~     Traveler's diarrhoea or turista is the most common disease in travelers. It has been~     reported based on studies in 20 to 60% of travelers, depending among other conditions and~     travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by~     bacteriological v,irological and parasitology traditional techniques. This ignorance of the~     diarrhoea etiology causes difficulties in the establishment of a specific and rapid~     management in this extremely common condition and having a significant cost to society.~     Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase~     Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's~     diarrhoea using simple rectal swabs.~      So, the principal objective of this study is to assess the efficacy of a new diagnosis~     strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The~     hypothesis consists in improving the number of patients with a confirmed etiological~     diagnosis of traveler's diarrhoea by 5%.~   "
14599|NCT02866188|"~     In this study, we want to find out whether the recognition of cardiac arrest using a smart~     watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using~     the smart watch is easy and fast to the witness, like a general person. By using the smart~     watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is~     beginning earlier than using conventional cardiac arrest recognition method in field.~   "
14600|NCT02866175|"~     There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy~     in subjects with atrial fibrillation AF following percutaneous intervention PCI with~     stenting. This study is designed to evaluate the safety and to explore the efficacy of an~     edoxaban-based antithrombotic regimen versus a vitamin K antagonist VKA-based antithrombotic~     regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety~     outcome in cardiovascular clinical trials, especially for antithrombotic strategies and~     invasive procedures.~   "
14601|NCT02866162|"~     Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases~     characterized by congenital neutropenia associated with the involvement of other organs.~     Most patients have syndromic congenital neutropenia, which does not correspond, either~     clinically or genetically, to any other previously described form. A large number of genes~     still have to be identified in these syndromic forms.~      The aim of this study is to identify the molecular bases of congenital neutropenias that~     have not yet been classified, by taking advantage of high-throughput exome sequencing.~   "
14602|NCT02866149|"~     Exploratory study on blood-borne biological markers and their correlation with clinical and~     pathological characteristics.~   "
14603|NCT02866136|"~     Conservative treatments of retinoblastoma (RETINO 2011)~        1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction~          (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8~        2. -Multicentric non randomised, phase II study for the patients with bilateral very~          asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups~          B/C/D according to the age and vitreous seeding~        3. - Multicentric non randomised, phase II study for the patients treated by 6 cycles of~          three drugs regimen and local treatments for bilateral group D eyes or on the only eye.~   "
14604|NCT02866123|"~     There are several ways to verify the correct positioning of a gastric tube. Radiography is~     considered the reference method. The use of ultrasonography could diminish the number of~     radiographies necessary. The hypothesis of this research is that gastric ultrasonography~     performed during insertion of the tube is a reliable examination to check the correct~     positioning of gastric tubes in intensive care.~   "
14605|NCT02866110|"~     Emotion-related brain activation is made visible for patients via neurofeedback with the aim~     to improve discriminability of emotional arousal and emotion regulation. With functional~     magnetic resonance imaging (fMRI), information of current brain activation is imaged and fed~     back to the patient via a visual display. Patients with borderline personality disorder~     (BPD) usually hyper-activate brain regions associated with emotion. In this study, BPD~     patients will be provided with neurofeedback from the amygdala, which is crucial for the~     processing of emotions. The aim of the study is to observe, whether amygdala-neurofeedback~     would help BPD patients to improve emotion regulation. Compared to a control condition,~     improved brain self-regulation and emotion regulation is expected with three neurofeedback~     training sessions.~   "
14606|NCT02866097|"~     This study will provide important evidence to the Ministry of Community Development, Mother~     and Child Health (MCDMCH) and the Ministry of Health (MOH) on how to effectively implement~     iCCM with a focus on improving both the flow of supplies to CHWs as well as the quality of~     their supervision and mentorship. The overall aim will be to determine whether improvements~     in supplies for community health workers (CHWs) and strengthened supervision result in~     improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea~     in rural Zambia when compared to CHWs offering iCCM without this logistics and supervision~     support.~   "
14607|NCT02866084|"~     This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric~     stimulation on vestibular migraines. All subject who meet the study criteria will be in an~     active treatment group. All subjects will report the frequency of the migraines and undergo~     periodic testing of symptoms.~   "
14608|NCT02866071|"~     STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects~     who report clinically important reductions in pain score (defined as 2 points on a 0-10~     verbal numerical rating scale) after receiving fentanyl (50mcg) with or without intranasal~     (IN) ketamine (50mg) prior to hospital arrival for the treatment of acute traumatic pain.~      Design and Outcomes This is a prospective, randomized, placebo-controlled single-site~     clinical trial. The primary outcome variable is reduction of reported pain of at least 2~     points (on the 0-10 Verbal Numerical Rating Scale1,2) when comparing the pretreatment pain~     score to the pain score obtained upon reassessment 30 minutes after medication~     administration. Secondary outcomes include: reduction of reported pain at Emergency~     Department (ED) arrival; the incidence of adverse events; additional opiate requirements~     prior to ED arrival and in the first three hours of ED care; development of chronic pain~     (measured by the Brief Pain Inventory,3) or post-traumatic stress disorder (measured by the~     PTSD Checklist for DSM-54) and overall satisfaction with life (measured by the Satisfaction~     With Life Scale5) at 90-days after injury.~      Interventions and Duration Adults who qualify for prehospital pain treatment under paramedic~     standing orders will be screened for inclusion and, if eligible, will undergo an~     IRB-approved consent process concurrent with receiving 50mcg fentanyl (IV or IN per current~     standard practice). Consenting subjects will be 1:1 randomized to receive either 50mg IN~     ketamine or IN placebo. Pain will be rated on a 0-10 scale by the subject prior to~     treatment, at 30 minutes following treatment, at ED arrival, and at 30 minute intervals for~     the first three hours of their ED care. Additional pain medications given prior to hospital~     arrival and within the first three hours of ED care will also be recorded. The primary~     outcome will be reduction in baseline pain between the pretreatment measurement and 30~     minutes after medication administration. Overall satisfaction with life and symptoms of PTSD~     and chronic pain will be assessed before hospital disposition (in-person) and via phone~     follow-up at 90-days (+/- 14 days) after injury.~      Sample size and Power The Investigators consider a two point reduction in pain to be~     clinically significant, and thus will compare the proportion of subjects achieving a two~     point reduction in pain at 30 minutes post-medication administration between the treatment~     group and the control group. Sample size considerations are based on this primary analysis.~     To test the hypothesis that the proportion of those treated with fentanyl alone that have at~     least a 2 point reduction in their pain will be lower than the proportion of those treated~     with the combination of fentanyl and single-dose ketamine who have a 2 point reduction in~     their pain, the investigators will use a chi-square test (or the Fisher's Exact Test if~     appropriate). An intent to treat approach will be used. It is expected the response rate in~     the two groups will be 40% and 60%, respectively. These estimates are based on the response~     rates in a study comparing pain management efficacy between subjects treated with morphine~     alone and morphine plus ketamine. With this magnitude of effect, a sample size of 97 per~     group will have 80% power to detect the difference between the two groups when the critical~     level of significance is set to 5%. To allow for subject drop-out, protocol deviations, and~     missing outcome data, the investigators plan to enroll an additional 15% in each arm, for a~     total of 224 subjects.~   "
14609|NCT02866058|"~     This study will examine the effect of cesarean section on perinatal mortality, using data~     provided by the Canadian Institute for Health Information.~   "
14621|NCT02865902|"~     Objective: The aim of this study was to determine the effects of Low Level Laser Therapy~     (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS).~      Materials and Methods: Forty patients requiring FGG were selected for this randomized~     controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and~     compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency,~     colour match (CM), and H2O2 bubbling test for the evaluation of complete wound~     epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning~     level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue~     thickness (TT) was measured at baseline and at the 1st month.~   "
14738|NCT02864381|"~     The primary objective of this study is to evaluate and compare the efficacy of GS-5745 in~     combination with nivolumab versus nivolumab alone in adults with recurrent gastric or~     gastroesophageal junction (GEJ) adenocarcinoma.~   "
14610|NCT02866045|"~     Sub epithelial lesions (SELs) of the gastrointestinal (GI) tract are commonly identified~     during routine endoscopy. Most of these lesions are benign. However because there is the~     potential for malignant transformation it is important to correctly identify the lesion in~     order to determine if any further therapy and/or surveillance is necessary for the patient,~     particularly for gastrointestinal stromal tumors (GISTs).~      Obtaining a definitive diagnosis for SELs is often difficult since biopsies of the normal~     overlying surface mucosal layer are typically normal. EUS-FNA is the standard method by~     which a biopsy-proven diagnosis is obtained for most SEL's. However, the yield for a~     definite diagnosis from EUS-FNA for SELs is often suboptimal. Recently a new biopsy method,~     called single incision needle-knife (SINK) was introduced that may prove more useful in~     determining a definitive diagnosis. Furthermore, recent advances in core biopsy needles for~     EUS offer the hope for improved outcomes with EUS-guided fine-needle biopsy (FNB). However,~     it remains unclear whether superior diagnostic outcomes are obtained using the new SINK~     biopsy method or using new EUS-FNB core needles.~   "
14611|NCT02866032|"~     The primary objective of this study is to evaluate the efficacy of topical MOB015B in~     patients with mild to moderate distal subungual onychomycosis (DSO).~      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild~     to moderate DSO.~   "
14612|NCT02866019|"~     The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial~     regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal~     wound site after extensive ESD for superficial esophageal cancer.~   "
14613|NCT02866006|"~     BVAC-C is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell.~     This study is Open-label, dose-escalation, multiple dosing study to evaluate the safety,~     tolerability, immune response and pre efficacy of BVAC-C in patients with multiple~     metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure~     to standard care. 9~18 patients will be enrolled~   "
14614|NCT02865993|"~     The purpose of this study was to evaluate, for the first time in Literature, the effects of~     betadine washing versus normal saline washing after uterine closure in women undergoing~     cesarean section (CS) at ≥36 gestational weeks in terms of post CS infections, complication,~     fever and pain.~   "
14615|NCT02865980|"~     This randomized clinical trial will conducted involving 60 patients under hemodialysis and~     hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were~     assigned to experimental and control groups of 30 people, randomly (double block). In the~     both intervention and control group, first will be washed the Catheter with Betadine, but in~     intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for~     15 seconds. The incidence and severity of inflammation as well as infection of vascular~     access will be assessed in patients on hemodialysis for each patient before starting the~     process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.~   "
14616|NCT02865967|"~     Asthma is the most common chronic condition in children and one of the five most burdensome~     diseases in the United States. Despite this, research and care for childhood asthma are~     limited by inefficient utilization of electronic medical records (EMRs) to facilitate~     large-scale studies and care.~      The primary goal of this clinical trial is to implement the asthma-Guidance and Prediction~     System (a-GPS) on the Asthma Management Program (AMP, a current care coordination program~     for asthma care of children aged 5-17 years at Mayo Clinic). Primary hypothesis: The~     implementation of a-GPS in the current care is logistically feasible.~   "
14617|NCT02865954|"~     he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is~     associated with incontinence, pain, reduced stability of the core and functional deficits.~     The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the~     correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard~     care. However, only a small proportion of women seek medical care for incontinence in~     Canada. Recently, there has been an influx of mobile Health technology applications marketed~     for pelvic floor restoration and fitness that have not been studied. The existence of~     mHealth technologies may represent an innovative mode to support pelvic health, however~     systematic exploration to substantiate claims and proposed benefit is required. This pilot~     study aims to understand the utility of a new mobile health application, iball, as a~     rehabilitation tool to promote optimal pelvic floor function and to correct pregnancy~     related pelvic floor dysfunction. The iball is comprised of a device and a mobile app, and~     it has been brought to market in Europe as a consumer product. The study aims to assess the~     acceptability, feasibility, and effectiveness of the iball as a pelvic floor muscle training~     intervention, in comparison to standard care.~   "
14618|NCT02865941|"~     It has been observed that target fortification on different schedules leads to meal to meal~     variation. It changes the ratio of protein to energy and the percentage of carbohydrate to~     non-protein energy which may, affect growth. In the past, the investigators have analyzed~     the outcomes of breast milk composition when target fortification is done with different~     analysis schedules. The investigators were able to measure the macronutrient intake for~     different milk analysis schedules via a theoretical model and show that the more frequent~     schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to~     a high variation of macronutrients. It was observed that, in all the breast milk samples~     measured twice per week, infants achieved on average the recommended macronutrients in line~     with current recommendations. Nonetheless, the model only looks at the macronutrient intake~     and does not investigates the relationship between macronutrient variation and its effect on~     growth.~      The aim of the current study is to compare a frequent schedule of measurement of~     macronutrient analysis with a reduced schedule of measurement and to study its affect on~     growth, protein accretion and metabolic parameter.~   "
14619|NCT02865928|"~     This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in~     subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will~     be enrolled into the study at presurgical testing. Subjects will be stratified based on~     surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or~     placebo. All patients will receive standard intraoperative anesthesia and standard~     postoperative pain control. The primary endpoint is the amount of opioid administered~     postoperatively. Secondary endpoints include postoperative pain intensity at timed~     intervals, amount of opioid administered intraoperatively and postoperatively, incidence of~     nausea and vomiting, time to discharge and patient satisfaction~   "
14622|NCT02865889|"~     Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for~     colorectal and gynecologic cancers. This innovation could be used either for staging purpose~     and therefore could steer global therapeutic options or for surgical management only.~      Increase knowledge and skills lead to an increase in the number and rate of the women this~     innovation could be offered. The project team observed a shift from traditional surgical~     management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.~      This innovation however increases some costs (the surgical stage) but decrease some others~     (the post surgical stage).~      Foreseeing the pace of the dissemination needs to have objective and reliable data about who~     had access to laparoscopic surgery and who didn't (and why) and accurate assessment of~     related costs.~      This program will focus on uterine cancer (both cervix and corpus).~   "
14623|NCT02865876|"~     The objective of this study is to evaluate the efficacy and safety of accelerated~     cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as~     adjunctive therapy.~   "
14624|NCT02865863|"~     A phase II randomized, placebo controlled study evaluating the efficacy of~     Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86~     healthy adults over a 24 week supplementation period.~   "
14625|NCT02865850|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of~     anemia and maintenance of HGB in subjects with DD-CKD.~   "
14626|NCT02865837|"~     The purpose of this study is to compare, for each patient, dosimetry of organs at risk~     (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a~     urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical~     cancer.~   "
14627|NCT02865824|"~     Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days~     in patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The~     purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding~     risks during polypectomy and if b) discontinuation of these drugs increases the occurence of~     thromboembolic events.~   "
14628|NCT02865811|"~     This research study is studying the combination of Pegylated Liposomal Doxorubicin (PLD) and~     Pembrolizumab as a possible treatment for Recurrent Ovarian, Fallopian Tube or Peritoneal~     Cancer that is resistant to platinum therapy.~      The following interventions will be used in this study:~        -  Pegylated liposomal doxorubicin (PLD)~        -  Pembrolizumab~   "
14629|NCT02865798|"~     Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after~     coronary artery disease, hypertension, and heart failure, especially in senile patients who~     have more comorbidities and often require intervention. The prevalence of senile VHD is~     increased gradually as the growth of the age. In addition important changes have occurred as~     regards the presentation and treatment of the disease over recent years. However, there is~     little information about senile VHD in China. The purposes of this study are to evaluate the~     clinical characteristics, reasons for hospitalization, risk stratification, treatment~     modalities, quality of life and outcomes of senile hospitalized patients with VHD, to~     determine the risk factors affecting the prognosis, further to lay the foundation for~     establishing a prognosis model suitable for Chinese senile VHD.~   "
14630|NCT02865785|"~     The aim of present study is to evaluate the effect of intralipid 20% infusion, once between~     days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy~     test on clinical pregnancy rates in women with unexplained recurrent implantation failure.~   "
14631|NCT02865772|"~     The aim of this study to determine the reference ranges of LBC on gastric aspirate in~     healthy term newborns.~   "
14632|NCT02865759|"~     To improve pregnancy outcome, 39 000 pregnant women will be randomized to receive~     information about Mindfetalness or to routine care. The level of randomization will be the~     antenatal clinics in the Stockholm area.~   "
14633|NCT02865746|"~     The objective of this randomized double-blind study was to evaluate the effect of~     betamethasone in the control of postoperative pain in patients undergoing endodontic~     treatment.~   "
14634|NCT02865733|"~     The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil~     Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH)~     after Fontan operation with univentricular physiology.~   "
14635|NCT02865720|"~     The purpose of this study is to determine if an investigational treatment is safe and well~     tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.~   "
14636|NCT02865707|"~     Ulcerative colitis (UC) is a relapsing chronic intestinal inflammation with no existing~     cure, that affects over 300 per 100.000 Canadians, the highest prevalence in the world. This~     disease leads to a significant economic burden due to frequent hospitalizations, continuous~     use of expensive medications to prevent flares, work losses. It also has a significant~     impact on the quality of life, a risk of colectomy and development of colorectal carcinoma.~     The standard drug therapies are expensive and potentially toxic, and mostly directed against~     the chronic inflammatory process.~      Relatively little is known about the pathogenesis of UC. One of the hypotheses is that UC is~     the result of a dysbiosis between disease-inducing and protective intestinal bacteria in a~     genetically susceptible host. Non-digestible dietary carbohydrates (NDC) stimulate the~     growth of protective endogenous intestinal bacteria which ferment them into short-chain~     fatty acids (SCFA), some of the latter with natural anti-inflammatory properties, and are~     called prebiotics. NDC are very inexpensive versus the standard drugs for UC and are easier~     to administer than probiotics. The investigator was the first to report that oral intake of~     NDC, the dietary β-fructans inulin plus fructo-oligosaccharides (FOS), reduced colitis in a~     genetically-induced rat colitis model. Both inulin and FOS reduced colitis, each NDC~     modifying specific luminal microbiota. A small trial with the same mixture of NDC in~     patients with active UC relapsing on oral 5-aminosalicylic acid (5-ASA) showed a~     dose-dependent clinical response, confirming the transnational potential of this NDC~     mixture.~      The investigators propose a randomized placebo-controlled trial to assess if inulin plus FOS~     can also prevent such relapses in UC patients with inactive disease on stable maintenance~     drugs. Primary hypothesis is that inulin plus FOS is effective adjunct therapy to standard~     drugs for maintaining clinical remission. The second hypothesis is that the colonic~     microflora and its metabolic function, altered by inulin plus FOS, or not, mediate~     protection or relapse in UC. The longitudinal design of this maintenance prevention study~     and by serially collecting colon biopsies, stool, serum and urine within the same patient~     before a relapse (inflammation) occurs, would enable to identify unique changes in the~     intestinal microbiota, their metabolic functions and also assess effects on host-immune~     response that are associated with remission or before a relapse occurs during treatment with~     beta-fructans, or not.~   "
14685|NCT02865070|"~     This is a pilot study is to test a wireless, skin-sensor device against current technology~     in the NICU to monitor vitals~   "
14759|NCT02864108|"~     The Human Trisome Project will significantly increase the speed of Down syndrome research~     and the understanding of associated medical conditions. Its biobank will provide~     de-identified samples to research.~   "
14637|NCT02865694|"~     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder define as high~     cholesterol level and premature death. The prevalence of FH reported in few countries~     however unknown in Iran. Thus determine the FH patient, finding diagnostic strategy and~     appropriate treatment are important. We intent to use cascade method to screening patients,~     also our expected outputs are to develop and implement a registry program for FH patients~     and their families and to study their genetic disorder. FH patients will be followed from~     management, treatment and prevention of Cardio vascular disease in order to increase~     premature death.~   "
14638|NCT02865681|"~     The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins~     (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor~     any and all side effects of the nasal Menopur.~   "
14639|NCT02865668|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     coadministered with canagliflozin in healthy fed and fasted participants.~   "
14640|NCT02865655|"~     To apply an existing diagnostic imaging test (saline infusion sonohysterography by~     Hysteroscopic) to characterize the filling defect of a previous cervical cesarean delivery~     scar in the nonpregnant uterus~   "
14641|NCT02865642|"~     In this study the investigators want to test the hypotheses that, serotonergic~     neuromodulation increases perilesional neuroplasticity, leading to improved behavioural~     outcomes through a more efficient allocation of functional resources, greater structural~     reorganization and less remapping via alternative circuits.~   "
14642|NCT02865629|"~     N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar~     disorder: a functional connectivity study~   "
14643|NCT02865616|"~     To measure the resolution of diarrhea as well as the feasibility of administration and~     safety of MET-1 for the treatment of recurrent CDI in patients who have experienced at least~     two prior episodes of CDI and have developed recurrence after having completed standard-of~     care oral antibiotic therapy to treat CDI.~   "
14644|NCT02865603|"~     The aim of this study is to measure the impact of the intervention (PAX GBG) during 7 months~     in Estonian-language 1st grade classrooms on students' mental health and behaviour, and~     teacher's self-efficacy.~   "
14645|NCT02865590|"~     The sinus infiltration technique for sinus floor elevation has been used successfully when a~     reduced vertical height is available in the posterior maxilla. However, the effect of the~     different graft material on the volume and on the quality of new bone formed has not been~     fully investigated. The aim of this study is to evaluate the clinical and histological~     effect of a test material, lyophilized equine bone (Bio-gen®), compared with control~     material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral~     approach.~   "
14646|NCT02865577|"~     Poor function of the right side of the heart and rise in pressure of the blood vessels~     leading to the lungs are two main heart-related factors that are associated with worsening~     of airway disease. A relatively new method which uses magnetic field to create images of the~     heart called cardiac magnetic resonance (CMR) imaging shows immense promise in detailed and~     accurate assessment of the heart in patients with airway diseases. This project aims to~     assess the heart in patients with asthma and chronic obstructive pulmonary disease (COPD) as~     well as healthy participants using CMR to help us determine features on CMR that are~     different is patients with asthma and COPD compared to healthy participants. This may help~     with early identification of patients who are at risk of episodes of acute worsening of~     airway disease, called exacerbation, and potentially halt the progression of the heart~     dysfunction with currently available or new treatments.~      Study involves one visit at Glenfiled Hospital, Leicester, lasting approximately 4 hours.~     The visit will include following assessments: clinical history, health status, physical~     examination, electrocardiogram (ECG), blood tests, lung function testing, echocardiogram and~     CMR. Part of the study will involve a participant questionnaire in which the participants~     will rate their CMR experience. The results will potentially change the way CMR is~     undertaken. A sub-set of the participants will also be invited back to do a one off focus~     group discussing the CMR experience further.~   "
14647|NCT02865564|"~     The aim of the study is to elucidate the relationship between postnatal antibiotic~     administration on development of gut microbiota and possible protective influence of~     simultaneously administration of probiotic during antibiotic therapy on development of gut~     microbiota, functional gastrointestinal disorders of infancy, weight gain and body~     composition.~   "
14648|NCT02865551|"~     The investigators intend to compare the rate of urinary retention among female patients~     after vaginal delivery under epidural anesthesia, depending on bladder catheterization type,~     either by a foley catheter inserted adjacent to epidural anesthesia or intermittent~     catheterization applied every 4 hours during labor.~   "
14649|NCT02865538|"~     This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose~     study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814~     will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will~     be dosed for 14 days.~   "
14650|NCT02865525|"~     Medication non-adherence is an economic problem and a major public health challenge. Factors~     influencing medication adherence can be modelled according to five dimensions: disease,~     medication, patient and its close relatives, demographic and socioeconomic factors and~     health care system. A tool is needed to qualify medication adherence in order to adapt~     tailored support for individual patients to promote and optimize adherence to therapy.~      The objective of this work is to present the preliminary results of QUILAM project which is~     divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence~     in chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument~     (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during~     educational interventions.~   "
14760|NCT02864095|"~     The purpose of this study is to compare the blood loss of intravenous and topical~     administration of low dose epinephrine plus combined administration of intravenous and~     topical tranexamic acid for primary total hip arthroplasty.~   "
15310|NCT02856880|"~     The aim of this exploratory study is to assess the ability of two test toothpastes~     containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate~     (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque~     bacteria using the plaque glycolysis regrowth model (PGRM).~   "
14651|NCT02865512|"~     It is known that postoperative pain after thoracotomy or lobectomy is very severe,~     therefore, intraoperative or postoperative pain management using continuous thoracic~     epidural catheterization is suggested good option to prevent this complication.~      The spread of local anesthetics is influenced by various factors including volume, location~     of needle insertion, speed of injection, patient position, age, weight and height. However,~     there are few studies about the effect of different patient position during thoracic~     epidural catheterization.~      This study was designed to evaluate the effect of different patient position affecting~     thoracic epidurography.~   "
14652|NCT02865499|"~     This study addresses a lifespan approach to healthy development and aging with direct~     relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot~     study to: i) better estimate power for a larger trial, ii) establish the safety and~     potential beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine~     whether the effects of acarbose on the microbiome likely play a role in its enhancement of~     longevity and/or healthy aging. These are essential initial steps for translating acarbose~     into an anti-aging human therapy.~   "
14653|NCT02865486|"~     In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions~     will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that~     they differ in terms of acid stability, lipid droplet size and fat redispersibility. The~     investigators hypothesize that the gastric emptying of fat will differ between the lipid~     emulsions.~      An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid~     emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded~     study.~   "
14654|NCT02865473|"~     The aim of the present study is to develop a measurement protocol for optimal imaging of the~     anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering~     bleb and pseudoexfoliation deposits on the lens based on measurements in patients with~     glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for~     classification, therapy, progression and prognosis and imaging of the angle between the iris~     and the cornea is the key for open angle and closed angle glaucoma differential diagnosis.~     For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to~     validate whether the protocol can also be more widely applied in these patients. Based on~     the obtained measurement protocol, further studies investigating anatomy and pathophysiology~     of the anterior segment of the eye as well as surgical outcome in patients with glaucoma and~     PEX can be planned.~      The aim of the study is to develop a measurement protocol for OCT imaging and~     characterization of the anterior chamber in glaucoma patients.~   "
14655|NCT02865460|"~     The primary objective of this clinical trial is to determine if treatment with ubiquinol, a~     form of coenzyme Q10, improves the physical function of men and women Veterans suffering~     from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the~     Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms.~     Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers~     in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity~     level, and cognitive and mental functioning.~   "
14656|NCT02865447|"~     Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral~     bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used~     as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip~     joint.~   "
14657|NCT02865434|"~     Prospective, open-label, multicenter, dose escalation, safety study of injected Tc 99m~     tilmanocept in the detection of and assessment of localization to skeletal joints in~     subjects with and without active RA by SPECT imaging.~   "
14658|NCT02865421|"~     Androgenetic alopecia (AGA) is a common form of hair loss in both men and women,~     characterized by progressive patterned loss of hair from the scalp. The current study has~     been designed for restoration of hair in AGA by implanting a combination of autologous~     mesenchymal stem cells (derived from the adipose tissue) and human platelet rich plasma.~   "
14659|NCT02865408|"~     Enhancing the anabolic effect of nutrition in critically ill patients by administering~     exogenous amino acids.~   "
14660|NCT02865395|"~     Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a~     variety of ailments. These procedures often require that the bladder be filled and emptied~     with sterile water or saline several times during the procedure, and often result in the~     patient receiving a catheter at the end of the procedure. One common side effect is that~     patients experience bladder spasm or discomfort for a period of time after these procedures.~     Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the~     post-operative setting to relieve these symptoms.~      The principle objectives of this study are:~        1. To determine if the addition of a B and O supprette suppository at the end of~          cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and~          urinary discomfort that patients experience in the post-operative setting.~        2. To determine if using peri-operative B and O supprette suppositories reduces the need~          for pos-operative oral Ditropan and use of narcotic pain medications.~   "
14661|NCT02865382|"~     Optical Enhancement Technology might be superior to the conventional HD-WL in detecting~     colorectal adenomas~   "
14662|NCT02865369|"~     A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir~     and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic~     hepatitis C genotype 1b Infection~   "
14663|NCT02865356|"~     The study is designed as a proof of concept, multi-center, randomized, double-blind and~     vehicle-controlled study with intra-individual comparison of treatments.~      Three age cohorts of patients will be included in the study according to the following age~     ranges:~        1. ≥18 years old (minimum 6, maximum 18 patients)~        2. >12 - 17 years old (minimum 6, maximum 18 patients)~        3. >2 - 12 years old (minimum 6, maximum 18 patients)~      The main objectives of study are:~      To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared~     to placebo topical solution for the treatment of patients with mild to moderate atopic~     dermatitis (AD).~      To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in~     patients with mild to moderate AD.~   "
16778|NCT02837731|"~     This study assesses the mean difference in fluid balance at ICU discharge and associated~     patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients~     with refractory hypotension in an ICU setting.~   "
14664|NCT02865343|"~     The investigators have an existing exercise program (N>70) with a unique population of~     individuals with spinal cord injury (SCI) who have been enrolled in FES-RT for at least 6~     months. Roughly half have high level SCI. Thirty individuals with high level SCI who have~     FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 4 months~     with either NIV or sham NIV. Before and after training, the investigators will assess~     maximal aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference.~     Based on the investigators current data, it is hypothesized that only those randomized to~     NIV will experience further increases in aerobic capacity and that these increases will~     relate to increases in cardiac output and arterio-venous oxygen difference. This~     Exploratory/Developmental Research project will lay the groundwork for a larger study of the~     impact of FES-RT+NIV to improve health and function in those with high level SCI.~   "
14665|NCT02865330|"~     Description:~      Multicentre observational study, not randomized. Ambispective character (retro and~     prospective). Opened to any member of the Asociación Española de Urología (AEU), public and~     private medicine.~      Justification:~      Active surveillance is a strategy proposed to control the overtreatment derived from the~     opportunist screening in prostate cancer (PCa).~      Its development in our country is erratic and different in every Center. This database tries~     to include most of patients included in active surveillance in Spain with a few minimal~     inclusion criteria.~      Multicentre registry and follow up of the active surveillance in Spain.~      Hypothesis:~      Mortality cancer specific for PCa includible in active surveillance to 15 years is lower~     than 5 %.~   "
14666|NCT02865317|"~     Cortical activity during rest and with stimulation by functional magnetic resonance imaging~     will be investigated in patients with OBPI.~   "
14667|NCT02865304|"~     The purpose of the present study was to prospectively evaluate the efficacy and safety of~     endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2~     negative metastatic breast cancer (MBC) patients.~   "
14668|NCT02865291|"~     The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of~     accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for~     self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases~     from the rectum.~      The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it~     improves management of fecal incontinence and improves quality of life.~      Patients will record bowel events in a daily diary over a 5 week period, which includes 1~     week of adjustment to device use, 2 weeks without using the device followed by 2 weeks using~     the device. Quality of Life questionnaire will be completed before and after use of the~     device. Stool leakage data collected when the device is not being used will be compared with~     data collected during use of the device to determine effectiveness.~   "
14669|NCT02865278|"~     Randomized placebo-controlled crossover study during which participants undergo two~     different experimental days. The participants consume a red grape based- drink (polyphenols:~     300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml).~     After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood~     samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after~     the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to~     evaluate bioavailability.~   "
14670|NCT02865265|"~     The association between ultrasound-guided Pecs II block and parasternal block can represent~     a valid alternative in the management of acute and postoperative pain syndrome after~     quadrantectomy with or without axillary dissection.~   "
14671|NCT02865252|"~     Osteoarthritis (OA) is the most prevalent form of arthritis and is reported to be the most~     important reason behind functional disability and musculoskeletal disorders among aged~     individuals. OA is a total joint failure; represented by pathological damage to articular~     cartilage, that affects bone, menisci, synovium, ligaments, and neuromuscular tissue. Knee~     OA could be responsible for pain and functional disability in 19.2% of individuals aged more~     than 45 years in the Framingham study and in 27.8% of such individuals in the Johnston~     County Osteoarthritis Project. However, in the third National Health and Nutrition~     Examination Survey (NHANES III), nearly 37% of individuals aged 60 years or older had~     radiographic knee OA. Oliveria et al. (1995) reported that age- and sex-standardized~     incidence rates of symptomatic hip, knee, and hand OA were 88, 240, and 100/100,000~     person-years, respectively. In addition, the incidence rates of symptomatic OA of the knee,~     hand, or hip increased rapidly at age 50 and then levelled off beyond age 70. There were not~     enough data to report the prevalence of OA in Arabic countries. However, a cross-sectional~     study performed in Saudi Arabia demonstrated radiographic knee OA in 53.3% of men and 60.9%~     of women, while about 18% of women and 10% of men had symptomatic OA. Although it is well~     established that OA is mainly caused by damage occurring in the joint because of~     degeneration and inflammation, there is no known cure for OA and our understanding of the~     pathological aetiology of OA is still deficient and poorly understood.~      The primary objective of this study is to investigate the immediate and the carry-over~     effect of MWM on pain and function in patients with knee OA. A secondary objective is to~     evaluate this effect among those patients who demonstrate features of central sensitization.~   "
14672|NCT02865239|"~     Breast MRI is performed in prone position which causes a number of questions. Indeed, the~     correlation with mammography and echography and the identification of preoperative lesions~     can be complex as echography and surgery are carried in supine position while mammography is~     performed in standing position.~      Moreover, the prone position is often considered as uncomfortable by the patients. However,~     there is few publications in the literature on breast MRI in decubitus position.~   "
14673|NCT02865226|"~     Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective~     control and a reduction of postoperative morbidity and mortality.~      The gold standard for local analgesia is the thoracic epidural. However, this technique can~     be dangerous with severe complications.~      The paravertebral block showed comparable efficacy to the thoracic epidural for local~     analgesia . In addition, it has a better safety profile. There are several installation~     techniques. The difference in efficiency of these laying techniques is unknown.~   "
15326|NCT02856672|"~     The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme~     Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate~     oropharyngeal seal pressure in different head and neck positions and perform similarly~     during pressure controlled ventilation in neutral position, despite differences in their~     structural design.~   "
14674|NCT02865213|"~     This experimental study will evaluate the effect of different methods for the molar~     intrusion (compared with the control group) in adolescent and adult patients with open bite~     malocclusion. The study sample will consist of 36 patients with anterior open bite. The~     sample will be randomly allocated into two experimental groups, in addition to a control~     group.~      The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi~     and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be~     used in the first treatment group, while miniscrews will be used in the second treatment~     group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes~     occurring after intrusion of posterior teeth will be assessed by using posteroanterior and~     lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be~     evaluated, in addition to the comparison of the post-treatment skeletal and dental changes~     that occurs between groups.~   "
14675|NCT02865200|"~     Aim: This study was planned for comparing physical activity levels, nutrition quality and~     quality of life of the individuals that are diagnosed with and without metabolic syndrome~     (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).~      Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and~     (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic~     characteristics of the individuals that participated the study were registered with a survey~     form. The long form of the International Physical Activity Questionnaire was used for~     determining physical activity levels of the individuals; whereas total numbers of daily~     steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener~     (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was~     used for the assessment of health-related qualities of life of individuals and Beck~     Depression Inventory (BDI) was used for the assessment of depression. In addition,~     biochemical analysis and anthropometric measurements of individuals were also taken.~   "
14676|NCT02865187|"~     SUMMARY:~      Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive~     age women with a prevalence as high as 15%. The clinical symptoms of PCOS including~     menstrual dysfunction, infertility, hirsutism, alopecia, acne, and the possible increased~     risk of diabetes and cardiovascular disease have been reported to be significant~     contributors to psychological morbidity and impact health-related quality of life. For women~     with PCOS, the changes in physical appearance and the associated mood disorders appear to be~     deleterious for sexual function.~      Vitamin D deficiency (<20 ng/ml serum concentration of 25[OH]D), which affects from 67% to~     85% of women,4 is closely linked to symptoms of PCOS. The main physiologic role of vitamin D~     is to regulate calcium and phosphorus homeostasis and to promote bone health. Although there~     has been an increase in awareness of the importance of sexual dysfunction and QoL in women~     with PCOS, few studies have evaluated the outcomes of treatment for PCOS upon sexual and~     subjective health status of women.~      The goals of this study are:~        1. To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian~          Syndrome (PCOS)~        2. To determine the effects of Vitamin D therapy, with and without hormonal~          contraceptives, on SDy in women with PCOS in the absence of depression.~      METHODS:~      The study will enroll 60 women diagnosed with PCOS and reporting SDy at the Wright State~     Physicians (WSP) OB-GYN Practice and the WSP Family Medicine Practice.~      All participants will take vitamin D 600IU/day and will choose between hormonal and~     non-hormonal contraceptive methods (target of 30 participants in each group). Participants~     will complete three study visits (Initial, Month 3, and Month 6). Vitamin D levels will be~     drawn at the beginning of the study and again at 3 and 6 months after initiation of vitamin~     D therapy. Each participant will be asked to complete the Female Sexual Function Index~     (FSFI) and the Beck Depression Inventory (BDI) prior to initiation of treatment and again at~     6 months.~   "
14677|NCT02865174|"~     Our purpose of this study is to conduct a prospective randomized controlled trial to~     investigate the blood-conservation effect of this two topical hemostatic agents in primary~     TKA procedures in patients with a risk of thromboembolic events. We will also observe if~     there is increased risk of thromboembolism by use of topical hemostatic agents.~   "
14678|NCT02865161|"~     This study is conducted to study the efficacy and safety of Niselat in patients with~     osteoarthritis.~   "
14679|NCT02865148|"~     Research indicates that up to two-thirds of patients with advanced cancer experience~     significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms~     are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach~     patients strategies to increase their sense of self-efficacy to manage symptoms may be~     helpful in alleviating multiple cancer-related symptoms. The efficacy of CBT protocols for~     reducing distinct symptoms in early-stage breast cancer has been shown; however the role of~     CBT protocols for multiple symptoms in late-stage cancer is less clear. The current study~     aims to investigate the feasibility and acceptability as well as obtain an initial estimate~     of efficacy of a novel, cross-cultural CBT intervention that addresses multiple symptoms in~     advanced breast cancer patients. The target outcomes of intervention will be reduction in~     symptoms of anxiety and depression, pain, and fatigue. A randomized controlled design will~     compare patients receiving a CBT protocol to a waitlist control in both Singapore and US~     patients. The larger goal of this collaborative effort is to determine the scalability of~     such an intervention that can potentially provide needed symptom burden relief to advanced~     cancer patients.~   "
14680|NCT02865135|"~     This research study is studying a therapeutic vaccine, named DPX-E7, as a possible treatment~     for Human Papilloma Virus or HPV related head and neck, cervical or anal cancer (positive~     for HLA-A*02).~   "
14681|NCT02865122|"~     The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620~     compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks~     old) with SBS following surgical resection~   "
14682|NCT02865109|"~     To provide access to nusinersen to eligible patients with Infantile-onset Spinal Muscular~     Atrophy (SMA) (consistent with Type 1) to address a high-unmet medical need.~   "
14683|NCT02865096|"~     This study is attempting to determine whether there is any effect (worsening or improvement~     of sexual function) after marijuana consumption. Both users and non users of marijuana will~     be given the opportunity to participate by completing a questionnaire.~   "
14684|NCT02865083|"~     The purpose of this study is to investigate the effects of the Traxi Pannus retractor in~     obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus~     retraction techniques. Patients will be randomized to the use of the Traxi retractor during~     Cesarean section (treatment group) or the use of traditional pannus retraction techniques~     (control group). The primary outcome to be followed is surgical site disruption. The~     investigators will also assess the duration of surgery or length of time from skin incision~     to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length~     of stay, need for hospital readmission or emergency room visits, or other complication rates~     between the two groups.~   "
14686|NCT02865057|"~     Vaginal exams are used routinely in labor to assess cervical dilation and position of the~     baby (facing anterior, facing to the right or left side, facing towards maternal spine).~     This technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to~     help confirm or correct the vaginal assessment by obstetricians, but has not been used to~     assess the utility of immediate feedback to improve the accuracy of vaginal assessment by~     physicians in training. The investigators plan to use ultrasound assessment to determine if~     this education is effective in increasing accuracy in the resident population.~   "
14687|NCT02865044|"~     The objective of this study was to evaluate and compare the acute bioavailability of EPA and~     DHA in wax ester form provided as a dietary supplement compared to a well-studied and~     defined ethyl ester formulation in generally healthy men and women.~   "
14688|NCT02865031|"~     Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin~     protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative~     vitreoretinopathy (PVR) in patients with perforating globe injuries.~      Methods: This is a prospective, single-center, open-label, interventional case series. A~     single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24~     hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated.~     ERG was done before injections, at day 10, and 3 months. Serial plasma decorin levels were~     assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included~     globe survival, retinal attachment rate, and PVR evaluation.~   "
14689|NCT02865018|"~     Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system.~     Patients have relapses (also known as attacks) which are often quite severe and leave them~     with significant disability. Without treatment, within 5 years 50% of NMO patients are blind~     in one or both eyes or require walking assistance (cane, walker or wheelchair).~      NMO has only been relatively recently described and is fairly rare. Most NMO patients'~     immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in~     certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they~     trigger a cascade of events involving the immune system which eventually leads to damage to~     the nervous system. This ultimately leads to disability, some of which is permanent.~      Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4~     antibody. However, recent experiments in animal models of NMO have shown the importance of~     what happens inside the central nervous system after the antibody binds to the nervous~     system cell. Specifically, researchers have noted the importance of a specific cell type,~     eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they~     could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular~     over-the-counter allergy medicine.~      Cetirizine is already known to be safe and well-tolerated in the general population. In this~     study, the researchers plan to add cetirizine on to patients' current NMO treatment. The~     researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO~     patients have less relapses and therefore less disability over the course of the year~     following initiation of treatment. The researchers also plan to study how cetirizine changes~     the immunological profile in NMO patients by examining blood and cerebrospinal fluid.~   "
14690|NCT02865005|"~     Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the~     treatment of acne vulgaris.~   "
14691|NCT02864992|"~     This study will look at how effective the study drug (tepotinib) is at stopping the growth~     and spread of lung cancer that carries a specific genetic alteration (MET exon 14 skipping~     alterations) and that did not respond to standard of care treatment such as chemotherapy~     (platinum doublet containing regimen). This study will also measure a number of other things~     including safety of the study drug and the side effects, how body processes the study drug,~     or how the study drug affects your quality of life. The study also has an optional~     pharmacogenetic research part. Pharmacogenetic research is an important way to try to~     understand the role of genetics in human disease and how genes impact the effectiveness of~     drugs, because differences in genes can change the way a person responds to a particular~     drug~   "
14692|NCT02864979|"~     This is a clinical prevention trial of mesalamine in patients with LS (Lynch syndrome).~     tumor free carriers of a known genetic mutation in a major (mismash repair) MMR gene will be~     randomized 1:1:1 to receive 3600mg 5-ASA (mesalamine), 1600mg 5-ASA, or placebo. Patients~     will be identified through local or national registries and through collaboration with~     satellite centers. Tumor free patients, assessed by colonoscopy, will be allocated to the~     study. After a 2-year intervention phase patients will be assessed by colonoscopy for the~     presence of colonic neoplasia. The investigators expect a 50% reduction of neoplasia in~     5-ASA-treated patients. Secondary endpoints are tumor multiplicity and trend analysis for~     the severity of the neoplastic lesion.~   "
14693|NCT02864966|"~     This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a~     panel of healthy adult subjects. The patches will be affixed to the back and remain under~     occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch~     removal.~   "
14694|NCT02864953|"~     This study evaluates the use of the investigational drug CIRARA versus placebo in patients~     with a large hemispheric infarction.~   "
14695|NCT02864940|"~     The study aim is to determine if periodic online cognitive exercises (Lumosity) improve~     memory function in ruptured cerebral aneurysm patients with disabling baseline memory~     deficits within the first 24 months after rupture. Half of the subjects will be randomized~     to use Lumosity-designed online cognitive exercises and half will serve as an active control~     group performing online crossword puzzles.~   "
14696|NCT02864927|"~     The purpose of the study is to perform the re-examination of Menactra® administered in the~     routine clinical settings in accordance with the Ministry of Food and Drug Safety~     regulation.~      Primary objective:~        -  To describe the safety profile after 1 dose of Menactra® administered from 9 months to~          55 years of age under standard health care practice.~   "
14707|NCT02864784|"~     Studies objectives:~      To evaluate the safety, tolerability and efficacy of AMOR-1 given in combination with ZA or~     with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:~        -  Safety and Tolerability:~        -  Adverse events (AEs) and serious AEs~        -  Safety laboratory measurements~        -  Hypercalcemic and hypercalciuric episodes~        -  Treatment withdrawal due to AEs and overall~      Efficacy:~        -  Skeletal Related Events (SREs)~        -  Measurable and evaluable disease progression~        -  Progression Free Survival (PFS)~        -  Pain assessment via the VAS scale~   "
14708|NCT02864771|"~     The purpose of this study is to identify markers of increased risk for incident ventricular~     arrhythmias and cardiovascular events in patients already being treated with an implantable~     cardioverter-defibrillator (ICD) by exploring patient history and clinical findings,~     biological markers, ECG markers, and echocardiographic markers.~   "
15327|NCT02856659|"~     Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To~     test speech understanding in each device and usability of upgrade.~   "
14697|NCT02864914|"~     Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose~     cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2~     diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk~     management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a~     post-authorisation safety study (PASS) to evaluate the liver and renal safety of~     empagliflozin. The study will also evaluate the risks of severe complications of urinary~     tract infections (UTIs) and genital infections. To evaluate the association between~     empagliflozin use and mentioned outcomes routinely collected health information from the~     Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of~     National Statistic will be used. This PASS will be conducted through an observational cohort~     study among adult patients with T2DM and at least 12 months of continuous enrolment in the~     CPRD where new users of empagliflozin will be compared to new users of other SGLT2~     inhibitors and to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be~     made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the~     primary and secondary outcomes. The primary outcomes will be: acute liver injury (ALI),~     acute kidney injury, hospitalization due to severe complications of urinary tract infection,~     and genital infections. The secondary outcomes will be: ALI in patients without predisposing~     factors, chronic kidney disease, outpatient severe complications of UTI, and genital~     infections resulting in hospitalization or systemic treatment.~   "
14698|NCT02864901|"~     This study is a Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1),~     multiple dose, single center study to evaluate the safety and proof of concept in a chewing~     gum formulation 3 times per day over 4 treatment days.~   "
14699|NCT02864888|"~     The primary objective of this protocol study is to investigate the effect of Antineoplaston~     therapy on the QT/QTc interval in study subjects age 3 to 21 years with newly-diagnosed,~     diffuse, intrinsic brainstem glioma. This investigation is to be conducted in parallel with~     a phase 3 efficacy and safety study of combination Antineoplaston therapy + radiation vs.~     radiation alone (BRI-BT-52).~   "
14700|NCT02864875|"~     The objetive of this study is to compare the treatment of two groups of politrauma patients~     that have fibrinogen deficiency (Fibtem < 9) diagnose by thromboelastography (ROTEM) but do~     not have clinical or laboratorial signs of coagulopathy at emergency room admission. One~     group will receive fibrinogen concentrate (Haemocomplettan) and the control group will be~     clinically followed. If any of the groups show clinical signs of coagulopathy it will be~     treated by anesthesiologist decision.~   "
14701|NCT02864862|"~     The purpose of this study is to evaluate the esthetic outcomes following immediate implant~     combined with the autogenous tissue graft or acellular dermal matrix compared to immediate~     implant alone.~   "
14702|NCT02864849|"~     This study is designed to test the efficacy and safety of total neoadjuvant induction and~     consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent~     capecitabine for MRI defined high-risk rectal cancer.~   "
14703|NCT02864836|"~     The distribution of stable (non-radioactive) isotopes in living organisms is increasingly~     studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive~     organisms, but also in mammals.~      The scientific community shows a growing interest in the study of the isotopic distribution~     of Cu in humans: this distribution can vary according to gender or nutrition. Concerning~     pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in~     cirrhosis.~      Additionally, a promising area of study focuses on the role of Cu in cancerous tumors,~     neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.~      Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are~     important: platinum penetrates into the cell through a Cu receptor, it interacts with the~     regulation mechanisms of Cu and platinum.~      Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in~     patients with breast tumor and of Cu in patients presenting breast as well as colorectal~     tumors.~      The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results~     highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of~     Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast~     tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the~     serum and the isotopic modifications happen earlier than usual modifications of biochemical~     tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3,~     Carcinoembryonic antigen (CEA).~      Currently, there is no information about the distribution of the stable isotopes of Cu in~     head and neck tumors.~      The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in~     tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor~     types, head and neck tumors and lymphomas, will be also investigated in order to determine~     if this distribution is specific of a tumor type or not.~      In case of positivity of this variation, the prognostic interest of these parameters will be~     evaluated.~   "
14704|NCT02864823|"~     Necrotizing scleritis with severe ischemia is refractory to conventional treatment because~     of avascular necrosis.~      The investigators assessed the therapeutic efficacy and safety of autologous perichondrium~     transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the~     therapeutic effects.~   "
14705|NCT02864810|"~     [18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will~     noninvasively assess thrombus in whole body with good sensitivity with information of~     thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and~     diagnostic performance of [18F]GP1 will be assessed in all subjects.~   "
14706|NCT02864797|"~     Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an~     important part of the female cancer in France with more than 15 000 new cases in 2012. As~     considerable progress have been made in diagnostic and therapeutic strategies, an important~     part of the gynecologic cancers are diagnosed at an early stage and globally, the after~     treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of~     evident interest to study health related Quality of Life (QoL) among these patients who will~     continue to live after their cancer and to consider QoL as a primary end-point, beyond~     overall survival.~      The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a~     working group initiated in Besançon and whose goal is to investigate QoL of gynecologic~     cancers' patients. It gathers several entities from the hospital of Besançon, namely the~     Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology~     Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical~     practice, with the main objective of longitudinally collecting and analyzing QoL data of~     these women.~      The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in~     September 2015 with the goal of assessing the feasibility of the cohort. The feature of this~     study is that patients answer to QoL questionnaires using tablets computer and the~     Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions~     to collect patient reported outcomes is drastically increasing those last years. It has been~     underlined that routinely collecting symptoms could increase both QoL and survival among~     cancer patients. It enables to use these data in real-time in routine practice by presenting~     QoL scores to physicians in simple graphical histograms for both transversal and~     longitudinal measurements and it ensures a reliable data collection.~   "
14709|NCT02864758|"~     The purpose of the study is to compare the one-year and two-year risk of each of the~     following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death~     between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF)~     during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus~     dabigatran~   "
14710|NCT02864745|"~     ICU acquired weakness contributes (ICUAW) to poor functional outcome in survivors of~     critical care. Most damage occurs during the first week of critical illness when patients~     are unable to cooperate with conventional active rehabilitation. Functional electrical~     stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term~     outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial.~     Adults (n=150) mechanically ventilated for < 48 hours from 4 ICUs who are estimated to need~     >7 days of critical care will be randomized to receive either FES-CE-based intensified~     rehabilitation or routine care, which will continue until ICU discharge. Primary outcome:~     Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional~     performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and~     muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle~     biopsies to look at mitochondrial function, fibre typing and regulatory protein expression~     in response to FES-CE.~   "
14711|NCT02864732|"~     The purpose of this study is to investigate the feasibility of applying neuromuscular~     electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and~     whether the electrical stimulation improve pain, function and muscle strength.~   "
14712|NCT02864719|"~     The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving~     Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary~     intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults~     with chronic fatigue.~   "
14713|NCT02864706|"~     This protocol is written to describe the procedures for a single 5, 6 or 7 year follow-up~     control visit of patients who participated in the 12-month SCHEDULE-study and the following~     3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit is to~     examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of~     everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard~     immunosuppressive regimen including CsA, on renal and heart function. During the time period~     of this follow-up examinations, this visit will be performed as part of a routine annual~     visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).~   "
14714|NCT02864693|"~     The purpose of this research is to evaluate benefits of a microprocessor controlled~     prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon~     fiber prosthetic ankle-foot device.~   "
14715|NCT02864680|"~     This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of~     magnocellular system (visual event-related potential, visual ERP).~      Secondary purposes of this study are to evaluate the impact of regular use of cannabis on~     the temporal sensitivity of magnocellular system (visual event-related potential), on the~     dynamics of cortical visual processing during face perception test (visual event-related~     potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).~      The ancillary study is a genetic analysis of a group of candidate genes that aims to~     identify biomarkers for changes in visual processing. This will allow to distinguish among~     more homogeneous and specific groups in future studies on larger cannabis user population.~     This ancillary study concerns all participants subject to their informed consent~     (facultative study).~   "
14716|NCT02864667|"~     Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in~     Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray~     detector PaxScan 4030MCT. The modified detector is essentially identical to the previous~     model except a different detector housing which allows a narrower dead-space between the~     active area and the top of the housing.~      The benefit of the modified detector is that it allows Koning to modify the patient exam~     table, achieving a flatter surface in the center. The flatter surface will increase patient~     comfort and improve workflow.~      Meanwhile, flatter surface may also affect patient positioning and the coverage of the~     breast. The adequacy of the overall image quality with the new table/detector should be~     verified by radiologists.~   "
14717|NCT02864654|"~     Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic~     digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site~     of muscle injury. All patients will receive cell therapy. This is a single arm study with no~     control.~   "
14718|NCT02864641|"~     The purpose of this project is to test the efficacy of Planet K, a mobile and web-based~     technology infrastructure specifically designed to (a) enhance youths' chronic kidney~     disease- and treatment-related knowledge through interactive and game-based educational~     materials; (b) support adherence to the treatment regimen through customized task prompts~     via mobile and web-based delivery; and (c) promote patient-provider communication through~     real-world data collection and feedback loops. Investigators will examine the effectiveness~     of the Planet K mobile app and website in improving treatment adherence, disease-related~     knowledge, transition readiness, condition management, and the psychological correlates of~     these variables in adolescents and young adults with chronic kidney disease (CKD).~   "
14719|NCT02864628|"~     A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two~     vaccinations with MVA-BN-RSV vaccine or placebo.~   "
14720|NCT02864615|"~     Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic~     body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR,~     mTOR or immune checkpoint inhibitors.~   "
14721|NCT02864602|"~     This is a volunteer study examining the effect of different doses of IV dexamethasone on~     prolongation of median nerve block in the forearm.~   "
14722|NCT02864589|"~     The purpose of this study is to evaluate the feasibility and acceptability of two different~     modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and~     adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or~     Vocal Tic Disorder (PTD).~   "
14723|NCT02864576|"~     Cognitive remediation (CR) and aerobic exercise have separately shown promising results in~     schizophrenia cognitive improvement, despite this, the impact in improving functionality is~     still limited. Aerobic exercise increases Brain Derived Neurotrophic Factor (BDNF) levels,~     promoting neuronal and cognitive plasticity, which can maximize the impacts of CR. The aim~     of this randomized controlled trial is to study the efficacy of a 3-month intensive program~     that combines CR plus physical exercise comparing it to cognitive remediation plus a control~     activity.~   "
14724|NCT02864563|"~     Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and~     evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic~     pattern is an important prognostic marker which might be taken into account for treatment~     stratification.~      This protocol deals with a prospective analysis of the genomic profile established by~     CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in~     France, to obtain genomic profiles and being able to determine their prognostic impact in~     the various protocols of treatment. The objective of this study will be a better therapeutic~     stratification in the future trials, studies or protocols of treatment.~   "
14725|NCT02864550|"~     Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay,~     bisexual and other men who have sex with men (gbMSM), with the potential for significant~     sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising~     rates of this STI have prompted a search for novel prevention solutions. A recent pilot~     study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool.~     This innovative approach to STI prevention has solid clinical precedent, both from the HIV~     pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for~     other infections. The overarching goal of this project is to determine whether the daily use~     of doxycycline is an efficacious and acceptable intervention for syphilis prevention in~     high-risk, HIV-positive gbMSM.~   "
14726|NCT02864537|"~     The aim of the study was to compare self-management of anticoagulant treatment with~     conventional anticoagulant treatment in Norway.~   "
14727|NCT02864524|"~     Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia~     syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program~     for lower thoracic and cervical spine.~      Study Design: A single-blind randomized controlled trial was conducted on patients with~     fibromyalgia syndrome (FMS).~      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to~     an experimental group receiving manipulative and massage therapy, or to a control group for~     exercise program.~   "
14728|NCT02864511|"~     The purpose of this study is to describe a safe and consistent technique for neck~     rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the~     intervention and determine the patients that would benefit most.~   "
14729|NCT02864498|"~     The purpose of this study is to determine whether orally administered DS107 (1g and 2g~     doses) is effective in the treatment of moderate to severe atopic dermatitis.~      Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.~      The study will enroll approximately 300 subjects.~   "
14730|NCT02864485|"~     Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor~     prognosis. In patients with resectable disease, surgery offers a distinct survival benefit.~     This study will offer live donor liver transplantation (LDLT) to select patients with~     unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on~     standard chemotherapy. Potential participants will be evaluated for liver transplant~     suitability and must also have a willing, healthy living donor come forward for evaluation.~     Those participants who undergo LDLT will be followed for survival, disease-free survival and~     quality of life for 5 years and compared to a control group of participants who drop out~     of study prior to transplantation due to reasons other than cancer progression.~   "
14731|NCT02864472|"~     The aim of this study is to compare the efficacy of early intervention of PDT combination~     compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV~     patients showing insufficient response with initial loading dose.~   "
14732|NCT02864459|"~     When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous~     breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated.~     When the patient is reintubated the mortality rate increases and the length of intensive~     care unit stay is also increased. It is vital to intensively assess the patient before~     extubation and correctly predict extubation success. Muscular ultrasound may be helpful in~     these situations.~   "
14733|NCT02864446|"~     Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell~     damage, has recently been proposed as a clinically useful measure in the early detection of~     necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium~     obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient~     as a marker for early detection.~   "
14734|NCT02864433|"~     The investigators aim to evaluated a public health program in Haiti that introduced an oral~     cholera vaccine as part of comprehensive control efforts for a major cholera epidemic.~     Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at~     preventing cholera in many settings, it had not extensively been used to control an~     outbreak, and it had not been extensively studied in populations that were previously naive~     to cholera (i.e. countries that had never had cholera before). This cholera epidemic was the~     first ever report of cholera in Haiti.~      After the cholera vaccination campaign was complete, the investigators aimed to evaluate the~     field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and~     determining if cholera patients had been vaccinated. The investigators compared the rate of~     vaccination in cholera cases to controls from the community that had not had cholera in a~     case-control study.~      The investigators also performed a second study - a bias-indicator study - that enrolled~     patients with non-cholera diarrhea, and community controls. The role of the bias-indicator~     study was to evaluate for potential sources of bias, since the investigators could expect~     that cholera vaccination should have no effect on non-cholera diarrhea.~   "
14735|NCT02864420|"~     The investigators propose a home hospital model of care that substitutes for treatment in an~     acute care hospital. Limited studies of the home hospital model have demonstrated that a~     sizeable proportion of acute care can be delivered in the home with equal quality and~     safety, reduced cost, and improved patient experience.~   "
14736|NCT02864407|"~     To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with~     COPD in a routine clinical practice setting~   "
15147|NCT02859025|"~     Our aim was to combine regenerative techniques with bone grafting in human models to~     increase predictability and survival of reconstructed tissue. The MSCs in this study were~     derived from an intra oral fat source (BFP) and were cultured over natural bovine bone~     mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat~     human alveolar cleft defects.~   "
14739|NCT02864368|"~     Newly-diagnosed glioblastoma multiforme with complete or partial surgical resection, CMV~     seropositive patients will be eligible to enroll on this 2-arm randomization trial.~     Following standard of care chemoradiation, eligible subjects will be consented and~     randomized to cycles of either 5-day standard of care post-radiation temozolomide (TMZ) or~     21-day dose-intensified TMZ. Subjects will receive tetanus-diphtheria (Td) pre-conditioning~     on day 22 of the first post-radiation cycle of TMZ and the following day, receive the first~     of 3 every other week via intradermal (i.d.) injections of the study drug cytomegalovirus~     peptide (PEP-CMV), a vaccine mixture comprised in 2 components (referred to as Component A~     and Component B) the next day. The subjects will resume cycles of TMZ, resulting in a 28-day~     delay between cycle 1 and 2, and continue PEP-CMV vaccinations every month with cycles of~     TMZ and then monthly to a maximum of 20 vaccines unless progression occurs.~   "
14740|NCT02864355|"~     The objective of this prospective, randomized controlled study is to ascertain whether the~     perioperative use of the FloTrac device to guide fluid and vasopressor management during~     esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary~     complications; however, the secondary outcome of decreasing patient morbidity (acute renal~     injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital~     stay.~   "
14741|NCT02864342|"~     A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on~     adherence in COPD patients~   "
14742|NCT02864329|"~     Basic and clinical research is revealing that various noncoding and small RNAs play~     important and diverse roles in germ cell development and quality, including X/Y silencing~     during meiosis, gene regulation, DNA damage responses, and protection of the genome against~     transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA~     species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific~     PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human~     infertility are largely uncharacterized. The goal of this study is to elucidate the role of~     small RNA pathways in the events that give rise to viable euploid gametes. Four projects and~     three cores are included in this study.~   "
14743|NCT02864316|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     radiation-induced solid tumors.~   "
14744|NCT02864303|"~     Although saliva is not generally regarded as one of the most interesting biological fluids,~     the fact that it can be sampled using simple, noninvasive methods makes it an interesting~     alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of~     salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant~     literature as well as various clinical trials. Saliva collection which is now well~     standardized has the major advantage of being simple and non-invasive. An original study had~     already discussed possible changes in the salivary composition in Alzheimer's disease (AD).~     The feasibility and the potential interest of measuring saliva concentration of the amyloid~     peptides was reported in an article published recently. The prospect of using saliva for~     early diagnosis and monitoring of AD is thus of major interest and the objective of the~     current trial.~   "
14745|NCT02864290|"~     The purpose of this study is to evaluate the safety and tolerability of AGS62P1 given at two~     dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, weekly), in subjects~     with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In~     addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the~     anti-leukemic activity of AGS62P1.~   "
14746|NCT02864277|"~     The aim of this study is to compare outcomes of conventional perioperative care with those~     of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing~     open abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators~     hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of~     hospital stay, without increasing readmission rates. ASD~   "
14747|NCT02864264|"~     The primary purpose of this study is to determine if single and multiple doses of BMS-986184~     are safe and well tolerated in healthy male and female subjects. The primary purpose of the~     proof of mechanism study is to determine safety and efficacy in patients with ulcerative~     colitis.~   "
14748|NCT02864251|"~     The purpose of this study is to determine whether Nivolumab+ chemotherapy and~     Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M~     negative NSCLC who failed first line (1L) EGFR TKI therapy~   "
14749|NCT02864238|"~     The economic burden of health care is becoming a greater burden from year to year. Medicare~     spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent~     to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was~     attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA)~     and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012.~      The push to create Accountable Care Organizations (ACO) has taken these initiatives a step~     further. The goal would be to move away from a fee for service system and base reimbursement~     on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories~     of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and~     healthcare associated infections will be the foci for 2013. Centers for Medicare and~     Medicaid Services (CMS) has also initiated a valve bundled payment system that encompasses~     total patient care for 90 days, including readmissions.~      Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care~     Improvement have placed quality and cost effectiveness into the spotlight for clinicians in~     the ICU and beyond. While clinicians have always been focused on evidence based therapies~     with little concern for cost, in the new era of healthcare understanding cost, value and~     effectiveness of therapies will be key for improved patient outcomes and institutional~     solvency in trying economic times.~      Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart~     and vascular institute identified the importance of an electronic medical record that~     includes display and utilization of key drivers of quality and success across the continuum~     of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of~     care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers,~     multi-specialty physicians, case managers, informatics specialists, and performance~     improvement representatives to develop an electronic pathway of care using evidence based~     and best practices for cardiac surgery.~   "
14761|NCT02864082|"~     Congenital ichthyosis (CI) is a large, heterogeneous family of inherited skin disorders of~     cornification resulting from an abnormality of skin keratinization, such as scaling and~     thickening of the skin. Treatment options include keratolytic agents, which can abruptly~     lead to extensive shedding or peeling of scales. PAT-001 primarily acts as a keratolytic~     agent; thus, making it a potential drug candidate for the treatment of skin disorders~     associated with hyperkeratinization, such as CI. The current study intends to evaluate the~     safety and tolerability of PAT-001 in patients with CI of either the Lamellar or X-Linked~     subtypes.~   "
15148|NCT02859012|"~     To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma~   "
14750|NCT02864225|"~     Background:~      Identification and measurement of fetal heart tracings throughout pregnancy and labor is~     crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most~     common indications for operative vaginal delivery or cesarean section. Therefore, management~     of labor requires reliable and accurate information about fetal heart rate.~      In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart~     rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic~     changes (accelerations or decelerations). In each stage of labor the tracing may have~     different characteristics, with variable decelerations much more common at the end of the~     second stage of labor.~      Objective:~      To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the~     reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the~     same patients.~   "
14751|NCT02864212|"~     The aim of this observational study is to create a data base to extract feature of~     fast-acting drugs that can be monitor in real time to design control strategies based on~     high order sliding mode controller to create a robust drug infusion system.~   "
14752|NCT02864199|"~     This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum~     concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and~     ribavirin combination therapy following single and multiple doses in participants with CHC~     infection and moderate to severe renal impairment or end-stage renal disease (ESRD)~     receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the~     target sample size is 48 individuals.~   "
14753|NCT02864186|"~     That study have the primary purpose identify if exist difference to the healing and quality~     of life between women that use of a surgical support bra, common support bra and without~     support bra after coronary artery bypass graft surgery.~      To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality~     of life life through specific instruments.~   "
14754|NCT02864173|"~     Postoperative cognitive dysfunction (POCD) presents as a long-lasting decline in cognitive~     function following surgery. Recognized as an important neuropsychological complication of~     anesthesia and surgery, POCD occurs predominantly in elderly patients, and even after minor~     procedures. It affects 41% of patients over the age of 60 years one week after major~     noncardiac surgery, and persists until the third postoperative month in 13% of cases. POCD~     has an adverse impact on quality of life, may result in prolonged hospitalization and~     increased health care costs, and is associated with the risk of leaving the labor market~     prematurely and dependency on social transfer payments, as well as increased one-year~     mortality. Elderly patients are particularly at risk. Other risk factors include a~     pre-existing cognitive impairment, cerebral, cardiac or vascular disease, diabetes, alcohol~     consumption and a lower level of education. The occurrence of postoperative delirium seems~     to predispose patients to POCD. However, POCD itself is not associated with the development~     of dementia.~      The pathogenic mechanism leading to POCD remains unclear. Numerous etiologic pathways have~     been suggested: cerebral ischemia due to impaired intraoperative cerebral perfusion and/or~     oxygenation, systemic inflammation and the effect of proinflammatory cytokines on the brain,~     altered cholinergic neurotransmission, anesthetic neurotoxicity, hormonal changes induced by~     surgical stress, sleep or circadian disturbances, or genetic factors.~      Several studies have explored possible associations between a specific genotype and POCD;~     however, these were predominantly performed in patients undergoing cardiac surgery or~     carotid endarterectomy. Previous reports primarily focused on the analysis of the~     apolipoprotein E genotype as a predisposing factor for POCD. Results of some of these~     studies have been pooled in a recent meta-analysis. Other studies have investigated~     polymorphisms of the human circadian clock gene HPER3, complement, cytochrome P450, platelet~     glycoprotein IIIa, phosphodiesterase 4D, P-selectin, C-reactive protein, and the inducible~     nitric oxide synthase promoter.~      The primary aim of this retrospective study of available cohort data is to investigate a~     specific genotype and to identify single nucleotide polymorphisms (SNPs) which may~     predispose elderly patients undergoing major noncardiac surgery to POCD.~   "
14755|NCT02864160|"~     Language barriers continue to impede access to quality care for limited English proficient~     populations. Recent research has demonstrated that access to language concordant providers~     increases quality of care. This project evaluates the efficacy and acceptability of a model~     intervention to improve second language proficiency, patient-centered communication, and~     clinical competency of nurse practitioner students who care for Spanish-speaking patients~     with diabetes.~   "
14756|NCT02864147|"~     This is a randomized Phase II, three arm control trial in patients with Cervical~     Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3~     meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study~     pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed~     from endocervical cytobrush samples to determine HPV status associated with the dysplasia.~      Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be~     randomized to one of three arms: observation only (control), imiquimod only, imiquimod +~     9-valent HPV vaccine.~   "
14757|NCT02864134|"~     BACKGROUND AND OBJECTIVES: The recent expansion of the applications of optical coherence~     tomography (OCT) demonstrated a higher correlation between the analysis of ganglion cells~     and visual function, in comparison with the analysis of the nerve fiber layer for several~     diseases of the optic nerve. Atrophy of the ganglion cells tends to induce the visual~     function deficits. In the case of optic neuritis, inflammation of the optic nerve causes a~     deficit of visual function initially with low vision, color blindness and visual field.~     Secondary atrophy of ganglion cell can result. The purpose of the study is to evaluate the~     correlation between the analysis of ganglion cells at the time of diagnosis of optic~     neuritis and the resulting visual acuity at 6 months and visual function (visual acuity,~     color vision and perimetry) 1 year regardless of treatment. A predictive effect could help~     predict the patient's clinical course and management of uncertainty and anxiety. MATERIALS~     AND METHODS: An assessment at diagnosis and follow-ups at 6 months and 1 year with a~     measurement of best corrected visual acuity, a test color vision HRR (Hardy-Rand-Rittler),~     an OCT with analysis of ganglion cells and perimetry Humphrey 30 -2 fast will be done.~     Simple linear and logistic regressions will be used. RESULTS: We expect that there will be a~     significant association between atrophy of ganglion cells in the diagnosis and residual~     visual function after an episode of optic neuritis. We believe that the initial atrophy is~     associated with poorer visual prognosis. CONCLUSION: A predictive effect could help to~     inform the patient about the evolution of the disease and provide early visual~     rehabilitation.~   "
14758|NCT02864121|"~     High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development.~     Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical~     cancer development. The aim of this study is to validate the integration of the HPV-HR as an~     appropriate biomarker of the severity of precancerous lesions and progression of cervical~     lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular~     Combing technology, which allows direct and high-resolution visualization of the integration~     of high-risk HPV genomes.~   "
14762|NCT02864069|"~     Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk~     for cognitive decline and dementia, with combinations of non-pharmacological interventions~     providing greatest promise for impacting cognitive aging. This, paired with limited~     cognitive benefits from pharmacological interventions in dementia, has shifted focus to~     non-pharmacological interventions administered earlier in the disease course. This~     application, therefore, proposes a randomized controlled trial (RCT; 12-week active~     intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided~     progressive increases in weekly step counts), computer-based cognitive training program~     (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on~     cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults~     with mild cognitive impairment (MCI).~   "
14763|NCT02864056|"~     This is a two-centre parallel group randomised controlled trial with an embedded process~     evaluation and intervention pilot phase (details not provided in this summary). The overall~     research question is: Can a Tai Chi exercise programme prevent falls among people with~     dementia (PWD), specifically among older PWD living at home?~      Primary Outcome measure:~      • dynamic postural balance (as a surrogate for falls).~      Secondary outcome measures:~        -  to explore the effects of a Tai Chi exercise programme on static and functional~          postural balance, fear of falling, cognitive functioning, falls, and quality of life.~          Also to explore the effects of a Tai Chi exercise programme on their informal carer's~          dynamic and static postural balance, quality of life, and carer burden~        -  to determine the acceptability and safety of the Tai Chi intervention~        -  to inform the design of a future definitive clinical trial.~   "
14764|NCT02864043|"~     The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research.~     Participation is completely voluntary and does not affect the patient's medical care that~     chooses not to participate. The purpose of this Study is to determine the performance of the~     NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE).~     This is done by the collection and analysis of the medical record information, imaging data,~     and pathology results. The information is then stored and may be used at a later time for~     various future analyses and publications. Any future analyses involving this Study will only~     use the information collected in this Study. No further involvement or additional informed~     consent of participants will be needed if future analyses are performed.~      This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE~     with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE~     surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an~     imaging procedure called VLE (volumetric laser endomicroscopy).~      The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration~     (FDA).~      Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging~     System at participating hospitals will be invited to participate in this Study. The Study is~     taking place at up to 4 hospitals, and as many as 100 patients may participate in this~     Study.~   "
14765|NCT02864030|"~     On March 17th, 2011, the European Commission issued a marketing authorization valid~     throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the~     treatment of patients with locally advanced or metastatic breast cancer who have progressed~     after at least two chemotherapic regimens for advanced disease.~      As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its~     safety profile outside clinical trials is warranted.~      Indeed the possibility to select patients at risk for developing Eribulin-induced~     neuropathy, will allow the exclusion from these treatment of those patients harbouring the~     specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in~     treatment discontinuation, the ability to anticipate which patients will experience severe~     toxicity could allow for either early intervention or even possibly for prophylactic~     therapy, or for selection of the patients to be treated.~   "
14766|NCT02864017|"~     The main objective of this study is to demonstrate that the only administration of~     L-citrulline, can improve immune functions in critically ill patients at high risk of~     nosocomial infection.~   "
14767|NCT02864004|"~     The aim of the study is to assess the use of the apomorphine pump in earlier stages of~     Parkinson' Disease (PD), when motor complications have just developed and before patients~     are significantly affected in their social and occupational functioning. The investigators~     hypothesize that apomorphine pump is superior in terms of positive impact on quality of life~     (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance~     of severe disabling motor complications thus favoring the maintain of patients' social and~     occupational status with a significant positive economic impact of the health system.~   "
14768|NCT02863991|"~     ONC201 is an orally bioavailable first-in-class small molecule with demonstrated antitumor~     activity in preclinical models of difficult-to-treat solid and liquid tumors without~     imparting significant toxicity. This is a Phase 2 open-label study of ONC201 administered~     orally once every 3 weeks as a single agent to patients with relapsed/refractory multiple~     myeloma.~      Funding Source - FDA OOPD~   "
14769|NCT02863978|"~     Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is~     very sensitive as newborns are exposed to a high risk of morbidity and mortality, with~     severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted~     a specific funding from the European Union in the framework of the Horizon 2020 programme~     (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to~     develop the Digi-NewB project. This project aims to develop innovative non-invasive~     monitoring tools to support decision making in health. Such tools include a new generation~     of real time monitoring in neonatology using composite indices made of cardio-respiratory~     variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all~     physiological data relevant for the creation of the composite indices.~   "
14770|NCT02863965|"~     The aim of the study is to evaluate the diagnostic value of high definition endoscopy and~     optic enhancement in gastric neoplasia.~   "
14771|NCT02863952|"~     The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to~     the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.~   "
16823|NCT02837146|"~     This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive~     very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and~     methotrexate (MTX).~   "
14775|NCT02863900|"~     The main objective of our project is to further characterize the deregulation of CE~     (Cholesterol Epoxides) metabolism in different moleculars subtypes of BC (BC=Breast Cancer)~     (luminal A and B, HER2+ and triple negative). We will study not only the level of expression~     of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved~     were identified in our preclinical work (GSTA1 (Glutathione S-Transferase A1 ), DHCR7,~     D8D7I, 11βHSD2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates~     of CE (hydrolyses cholesterols-5,6-epoxide ), CT (into cholestane-3β, 5α, 6β triol ), DDA~     (Dendrogenin A)and OCDO (6-oxo-cholestan-3β, 5α-diol ). Our preliminary results demonstrate~     the feasibility of these dosages. We will also establish whether these deregulations are i)~     correlated with different histo-prognostic parameters (pN (N= Node), pT (T= Tumor) , EV,~     TIL…) but also clinical ii) an independent prognostic parameter of BC in terms of~     disease-free survival, metastasis-free survival and overall survival. The cohort consists of~     350 cases of BC, treated between 2009 and 2011 as well as all relevant clinical~     informations. In parallel, we will continue our preclinical work by characterizing the~     targets and mechanisms of action of OCDO. Our preliminary results indicate that OCDO is a~     modulator of the glucocorticoid receptor (GR), which could be target to inhibit this~     pathway. On the other hand, we will characterize in the same manner as in human tumors, the~     deregulations of the CE metabolism in vitro and in vivo (including xenografts in mice of~     human tumors, in collaboration with Roman-Roman S) on a representative panel of BC molecular~     subtypes, sensitive or not usually administered in clinical treatment and study the~     anti-tumor effect of various anti-OCDO therapies (therapies preventing its production such~     as Tam (tamoxifen) or DDA, inhibitor of the enzyme producing OCDO, or an inhibitor of the GR~     (glucocorticoid receptor )), alone or in combination with conventional therapies~   "
14776|NCT02863887|"~     The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits,~     increased physical activity, improved blood glucose and cholesterol, and weight related~     quality of life in obese African American adults through a sustainable, technology enhanced,~     church-based program.~   "
14777|NCT02863874|"~     INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some~     form of perineal tear and of these 60-70% will require suturing. It is of great importance~     that operators are familiar with the best suturing technique and suture material in order to~     minimize possible associated short- and long-term sequelae. There is evidence for suturing~     continuously to reduce postoperative pain and superficial dyspareunia, but the choice of~     suture-material is still debated. The function of a suture is to close the wound to minimize~     the bleeding, the risk for infection and to adapt the wound edges to promote anatomic~     correct healing. Infection results in softened wound edges, shirked sutures, pain and~     dehiscence. Delayed and/or compromised wound healing is correlated with impaired strength in~     the affected tissue. Reported frequency of infection after first and second degree tear is~     between 1 and 11% where the discrepancy most likely is due to poor registration and~     follow-up. In 2004 Polyglactin 910 was launched with a new antibacterial coating of~     Triclosan (VicrylPlus®). Studies suggest a correlation between the use of VicrylPlus® and a~     reduction of up to 30% of surgical site infections (SSI) compared to conventional sutures in~     a non-colonized wound.~      OBJEKTIVE: The primary objective is to compare infection rates and pain intensity when using~     Vicryl® versus VicrylPlus® for perineal repair after delivery. Secondly, to show if there is~     difference in insufficient wound healing or superficial/deep dyspareunia after one year~     between the two groups.~      METHODS The participants are randomly allocated to continuously suturing with either Vicryl®~     or VicrylPlus®. Sealed identical looking envelopes are prepared and placed in the delivery~     room (randomized into blocks of 50, 948 in total) containing randomization number, sutures,~     declaration of informed consent and questionnaires. The participants are instructed to fill~     in the first questionnaire after 7 days and the second questionnaire after 8 weeks post~     partum. After 8 weeks all participants are offered a routine visit to the out-patient~     clinic. After one year an internet-based survey will be sent out to the participants. In~     case of complains/signs of deficient healing after one year the woman will be offered a~     clinical control. Data will be analyzed according to intention to treat.~   "
14778|NCT02863861|"~     The purpose of this study is to compere between Propofol-Ketamine combination and~     Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in~     paediatric patients.~   "
14779|NCT02863848|"~     The main objective of this Pilot study was to assess the beneficial effects of a daily~     supplementation with Orafti inulin‐type fructans in 2‐5 year old constipated children The~     study is primary aimed to develop a feasibility study to assess the beneficial effect of~     inulin‐type fructans in the described population with regard to the adequate criteria for a~     larger trial. Secondary objectives are to obtain data about the feasibility of the protocol~     (as pilot study). To obtain data useful to perform sample size calculations for a big study~     designed specifically to investigate the beneficial effect of inulin‐type fructans in the~     treatment of constipated children.~      Study design and subjects: Double‐blind, randomized, placebo‐controlled parallel group~     trial; where 2‐5 year‐old constipated children received inulin‐type fructans or the same~     amount of placebo (maltodextrin) during 6 weeks. The study protocol was approved by the~     local Ethical Committees.~      Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency,~     gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication~     required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention~     and after follow‐up were obtained in order to be analysed to know about the microbiota.~     Dietary intake was also recorded at baseline, end of intervention and after follow-up.~      Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III~     constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency).~     Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of~     laxative during the study and 2 weeks before, use of pre‐ probiotics or antibiotics during~     the study and 4 weeks before, organic causes of defecation disorders, other metabolic or~     renal abnormalities or mental retardation, no parent's command of any local language.~   "
14780|NCT02863835|"~     Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the~     lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and~     specially Bronchiolitis Obliterans Syndrome (BOS). Hence, for this study, the investigators~     aim to show that EIT would provide an accurate diagnostic CLAD with an ability to to~     distinguish BOS from Restrictive Allograft Syndrome (RAS) and to stage BOS accurately when~     compared to FEV1 the current gold standard. The investigators are also aiming to provide~     physiological data in lung transplant recipients with chronic rejection.~   "
14781|NCT02863822|"~     The purpose of this study is to evaluate the effectiveness of the low fermentable~     oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The~     investigators will compare education in the low FODMAP diet to a standard healthy diet for~     improving symptoms in FD.~   "
14782|NCT02863809|"~     This is a phase I/II prospective, randomized, multi-center, double-masked,~     vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen~     cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for~     high-risk keratoprosthesis implantation but because of a history of corneal melts or~     autoimmune diseases are not candidate for a traditional corneal transplant.~   "
14783|NCT02862977|"~     The purpose of this study is to evaluate the safety and efficacy of an association with one~     anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory~     plus caffeine in the treatment of osteomuscular pain in adults.~   "
14812|NCT02863406|"~     Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients~     suffering from sarcoidosis.~      Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron~     Microscopy and MicroAnalysis.~      For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies~     (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific~     Professional and environmental questionnary.~      Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco~     consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year,~     smoking more than 10 pack-year)~   "
14784|NCT02863783|"~     RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of~     pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been~     developed which enables fiducial coils to be placed at the precise site of biopsy.~      INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to~     place fiducials in the tumor. During surgery we will assess whether it improves tumor~     visualization.~      OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to~     mark pancreas tumors in 20 patients and to assess whether the fiducials impact tumor~     visualization during pancreas surgery.~      STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions.~      STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully~     placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and~     ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis~     with the intention to assess feasibility and to gather data to power larger trials.~   "
14785|NCT02863770|"~     RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but~     there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas~     and neoplasia in the setting of pancreatitis.~      INTERVENTION: The innovation in this project will be the addition of intravenous contrast to~     standard EUS examination if the pancreas.~      PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately~     diagnose lesions and target biopsies, and to define the quantitative features of this~     method.~      STUDY POPULATION:The population will include patients with pancreas cysts, masses, and~     inflammation presenting for EUS as part of standard clinical care.~      METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by~     EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging.~      ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts,~     masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen~     lesion will be assessed. Intra and interobserver variability will be assessed by comparing~     conventional EUS and contrast EUS of each case in a random order (intraobserver agreement)~     and among a group of blinded endosonographers (interobserver agreement).~   "
14786|NCT02863757|"~     The purpose of this study is to determine the disease progression in CHB/NAFLD compared with~     CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular~     carcinoma (HCC).~   "
14787|NCT02863744|"~     Assessment of wound healing progression after surgery is important. Currently blunt~     surrogate markers such as probing is used. Limitation of these markers is that it represents~     the history of healing and not the ongoing activity. As hallmark of healing is collagen~     remodeling, it is of interest to study the cytokine profile that relates to wound healing.~     Such knowledge may potentially lead to new diagnostic strategies to study wound healing in a~     better way reflecting the healing phenotype. Understanding wound healing at molecular level~     provides an in depth basis to develop treatment strategies that can prevent delayed~     healing.2 As recommended by Consensus Report of 10th European workshop on periodontology~     that, there is a need for more studies at cellular level to identify cytokine, chemokine,~     and intracellular signaling networks for better regenerative approaches10, the present~     clinical trial was designed.~      On account of a considerable lacunae in this area of periodontal research, this study is~     planned to assess the MMP-8 levels during the post-op healing following CAF+SCTG surgery for~     recession coverage and to better identify the mechanism involved in wound healing. This~     information can be used to prevent the normal surgical wound from altered healing~     experience.~   "
14788|NCT02863731|"~     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases,~     diabetes, several types of cancer and all-cause mortality. In combination with static and~     awkward postures, the prevalence of musculoskeletal diseases can increase further. Although~     the implementation of sit-to-stand or active workstations can help to reduce sitting time,~     improve physical activity at work and promote health benefits, it might also lead to changes~     in cognitive functions such as productivity. The purpose of this study is to evaluate the~     short-term effect of alternating working postures on cognitive performance for healthy~     people.~   "
14789|NCT02863718|"~     This is a prospective, multicenter, randomized, placebo-controlled, double-blind phase III~     study that compares the efficacy and safety of oral ibrutinib in previously untreated Binet~     stage A CLL patients without treatment indication according to iwCLL guidelines but risk of~     early disease progression.~      For event-free survival (EFS), an improvement from 24 months for untreated intermediate or~     (very) high risk CLL to 48 months for subjects treated with ibrutinib is considered~     clinically relevant. Ibrutinib / placebo is administered continuously orally until~     symptomatic disease progression, unacceptable toxicity, or voluntary treatment withdrawal,~     whichever occurs first.~   "
14790|NCT02863705|"~     The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN®~     (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine~     tartrate/timolol malate) and also in patients who require additional IOP lowering with~     LUMIGAN® (bimatoprost) 0.01%.~   "
14791|NCT02863692|"~     Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic~     leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL),~     T/Natural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL)~     and Richter's transformation~   "
14792|NCT02863679|"~     This study was taken out to assess the postoperative analgesic efficacy of tetracaine~     hydrochloride gel in patients with intrauterine adhesion treating with intrauterine~     balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel~     group and control group.~   "
14793|NCT02863666|"~     Prospective observational clinical study to verify an algorithm used to predict~     cardiopulmonary events in patients presenting to the emergency department.~   "
14794|NCT02863653|"~     Objective: To evaluate what factors contribute to social participation restrictions in~     subjects with Rheumatoid Arthritis (RA), considering the model International Classification~     of Functioning (ICF).~      Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using~     instruments to measure two constructs of component social participation.~   "
15617|NCT02852876|"~     The objective of this study is to evaluate the safety and tolerability of single rising~     doses of ASP2151 under fasted condition in healthy male subjects.~      The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under~     fasted versus fed conditions in healthy male subjects.~   "
14795|NCT02863640|"~     Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among~     the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE)~     and the external segments of the retinal photoreceptors, plays a crucial role in this~     pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients~     treated with the L-DOPA, developed only later an ARMD when compared to the untreated~     patients.~      The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical~     pole.~      This receptor, via several intracellular mechanisms, regulates the cell's exosomal and~     endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases~     significantly the RPE's exosome release.~      The contents of the exosomes is still uncertain, however in addition to their signalization~     role, it seems they transport pro-inflammatory components, possibly helping the cellular~     recruitment due to the mononuclear phagocytic systems, particularly toxic for the~     photoreceptors.~      The aim of this study is to validate the hypothesis stating that he L-DOPA would play a~     protective role against age related macular degeneration.~   "
14796|NCT02863627|"~     This study will evaluate the course of care of newborns, to understand why some newborns~     have improper care pathways, particularly as regards the first medical consultation at the~     exit of motherhood. It is also to organize a better quality care network to hospital~     discharge to avoid unnecessary use of pediatric emergencies, which represents a real public~     health problem.~   "
14797|NCT02863614|"~     The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam~     reduce the pain associated with endometrial scratching/injury.~   "
14798|NCT02863601|"~     The primary purpose of this study is to determine whether buprenorphine and metabolite~     exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs~     during pregnancy and between pregnancy and the postpartum state.The study will define the~     pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing~     based on objective, physiological parameters of satiety. The study will also determine which~     maternal, placental or fetal factors impact the risk of Neonatal Abstinence Syndrome (NAS)~     and will define neonatal exposure to buprenorphine through breast milk.~   "
14799|NCT02863588|"~     Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible~     for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may~     reactivate without known reasons, causing severe irreversible visual loss. The overall~     recurrence rate of OT in Europe is greater than 80% for patients and may range from one~     episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not~     reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted~     in these immunocompetent patients. These clinical and biological expression changes might be~     related to an individual genetic susceptibility of each patient. The advanced analysis of~     the entire genome now possible to consider the project.~   "
14800|NCT02863575|"~     An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental~     pain.~   "
14801|NCT02863562|"~     Soccer is a sport that attracts many participants and leads to a substantial number of~     injuries, especially of the ankle. Enhancement of functional joint stability by kinesio~     taping proprioceptive training may be important both in prevention and rehabilitation of~     ankle injuries. The main aim of this study was to determine the effect of kinesio taping and~     proprioceptive exercises on parameters related to ankle stability, such as the injury~     incidence, pain, static or dynamic stability and flexibility, in amateur soccer players~     training 3 times a week.~   "
14802|NCT02863549|"~     The aim of this study was to investigate the procedural feasibility and 30-day results of~     transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in~     selected, highly symptomatic patients with severe tricuspid regurgitation (TR).~   "
14803|NCT02863536|"~     The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months,~     clinical study.~      Interventional, non-controlled, multicenter trial with a prospective design on one cohort of~     patients~   "
14804|NCT02863523|"~     The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a~     unique collaborative, stepped-care intervention for patients with uncontrolled Type 2~     diabetes and co-morbid distress and/or depression.~   "
14805|NCT02863510|"~     A pilot, single-center, prospective, observational study. The objective is to demonstrate~     that catheter-based renal denervation using carbon dioxide renal angiography in patients~     with moderate to severe chronic kidney disease can be performed for treatment of~     uncontrolled hypertension.~   "
14806|NCT02863497|"~     This study aims to determine if there is an impact on sexual distress using~     mindfulness-based sex therapy (MBST) in addition to standard urogynecologic care, in women~     with both urinary incontinence (UI) and sexual dysfunction.~   "
14807|NCT02863484|"~     The blood loss will be compared in middle fossa meningiomas which will receive pealing of~     the outer layer of the lateral wall of the cavernous sinus and those which will not revive~     pealing before the dura is opened~   "
14808|NCT02863471|"~     In patients with peritoneal metastases of colorectal cancer could be a radical removal of~     all tumor foci a significantly improved survival compared to a sole systemic chemotherapy~     are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).~   "
14809|NCT02863458|"~     The study aims to comprehensively analyze data from a large and unselected older AML~     population in the US, both treated and untreated. These data will widen understanding of~     treatment decisions for the older Acute Myeloid Leukemia (AML) population. Through use of~     the SEER-Medicare Registry, the effectiveness and impact of HMA treatments as well as the~     effectiveness of lenalidomide will be studied.~   "
14810|NCT02863445|"~     Obese women are significantly more likely than their normal BMI counterparts to experience~     failure of orally-dosed emergency contraceptives. The PI's preliminary data provides~     evidence for testing a dose escalation strategy in an effort to provide improved efficacy~     from orally-dosed emergency contraceptives in obese women. The overall project will be~     focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency~     contraception but this protocol registration is for the LNG aspect of the study procedures.~   "
14811|NCT02863419|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and~     safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2~     Diabetes Mellitus.~   "
14813|NCT02863393|"~     The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes~     and hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin~     resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary~     function, the oxygen content of the body and therefore reduces inflammation of cells. The~     aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing~     exercises instead of aerobic exercise to reduce the fat in liver inflammation.~   "
14814|NCT02863380|"~     The investigators hypothesize that personalizing the rTMS targets using functional MRI will~     increase its efficacy. The most dysfunctional regions or the most dysfunctional network will~     be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS~     procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over~     trial.~      In this pilot study the primary outcome measure will be the correction of the MRI anomalies.~     Symptoms reduction and the proportion of remitters will be secondary outcome measurements.~   "
14815|NCT02863367|"~     Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in~     advanced metastatic pancreatic cancer.~   "
14816|NCT02863354|"~     The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept~     injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal~     non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR) primarily~     assessed through retinal capillary non-perfusion.~   "
14817|NCT02863341|"~     This is a multi-centre study in Singapore nursing homes, investigating the factors that~     affecting deprescribing, and if a team-care based deprescribing standard practice gives~     superior health and pharmacoeconomic outcomes over current medication review practice.~   "
14818|NCT02863328|"~     This trial is conducted globally. The aim of this trial is to investigate Efficacy and~     Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.~   "
14819|NCT02863315|"~     The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal~     direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord~     injury who have chronic neuropathic pain.~   "
14820|NCT02863302|"~     The aim of this study is to test a complementary therapy intervention (reflexology) that~     will assist in improving quality of life (QOL) for patients undergoing chemotherapy for~     acute myeloid leukemia. within the context of conventional medical care. Quality of life~     will be assessed via intermediate indicators: 1) physical indicators (greater physical~     functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality,~     lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3)~     chemotherapy side effects associated with the digestive system.~   "
14821|NCT02863289|"~     To date, the clinical benefits and harms of surgical intervention in proximal humerus~     fractures in children remain debatable. The practical question raised by orthopaedic~     surgeons is: for children and adolescent, are the clinical and radiological outcomes after~     non-operative management as equivalent as after surgical management for proximal humerus~     fractures? The investigators' hypothesis is that due to the healing potential of the~     proximal humerus, the outcome from this fracture is usually excellent.~      The investigators have applied for Caldicott approval to identify a cohort of eligible~     patient from NHS Tayside's radiography service. With the community health index (CHI)~     number, the investigators can review all shoulder X-rays performed in children and~     adolescents, aged from 10 to 18-year-old in NHS Tayside, from 2008 to 2015. The Caldicott~     approval also allowed the investigators to obtain clinical communication from the Clinical~     Portal (electronic summary healthcare records). The investigators will then conduct mail~     questionnaires, based on the Upper Extremities Functional Index (UEFI). The investigators~     will send out invitation letter with participation information and the UEFI questionnaires~     to the eligible patients; with return postages. If no response within 2 weeks, the~     investigators will send out 1 further reminder. If no further response, the patient will be~     excluded from the study.~   "
14822|NCT02863276|"~     Background Surgical injury provokes a stress response. These pathways mediated by stress~     hormones and cytokines cause a catabolic state. The loss of body cell mass may result in~     prolonged convalescence and increased morbidity. Protein catabolism after colorectal surgery~     is even more increased in patients with type 2 diabetes mellitus. Epidural blockade, by~     reducing the intensity of the catabolic response, improves substrate utilization after~     surgery in non-diabetic patients. This effect is even more pronounced in diabetic patients~     receiving amino acids.~      The aim of the study is to explore the effect of two different protocols to manage blood~     glucose control on glucose and protein metabolism in patients with type 2 diabetes mellitus~     undergoing colon surgery and receiving epidural analgesia and perioperative feeding with~     amino acids. The following hypotheses are tested:~        1. Tight perioperative blood glucose control with intensified insulin therapy compared to~          standard blood glucose control in presence of general anesthesia with epidural~          analgesia and amino acid infusion would reduce endogenous glucose production and~          leucine oxidation.~        2. Tight blood glucose control and perioperative infusion of amino acids induce a more~          positive protein balance compared to standard blood glucose control by better oxidative~          glucose utilization and redirecting amino acids from oxidative to synthetic pathways.~      Material and Methods A total of 20 patients with diabetes mellitus type 2 undergoing~     elective colorectal surgery will be admitted to the study. Patients will be randomly~     assigned to receive standard blood glucose control (blood glucose target <10 mmol*l-1;~     control group; cytotoxic T lymphocyte (CTL) group, n=8) or to receive tight blood glucose~     control with intensified insulin therapy (blood glucose target<6 mmol*l-1; intensified~     insulin group; II group, n=8). All patients will receive general anesthesia and an epidural~     catheter for perioperative analgesia. During surgery (intraoperative state) and immediately~     after surgery (postoperative state) when receiving an amino acid infusion protein and~     glucose kinetics will be assessed using a stable isotope technique with L-[1-13C]leucine and~     [6,6-2H2]glucose and circulating concentrations of glucose, glucagon, insulin and cortisol~     will be measured. The primary endpoints of the study will be protein balance. Sample size is~     set to ensure at least 80% power at a significance level of 0.05.~   "
14823|NCT02863263|"~     This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane~     foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment~     is 20 patients, with 10 patients per arm.~   "
14854|NCT02862847|"~     Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute~     diarrhoea. They have been identified in the pathological stools of infants and~     immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8%~     depending on the virus, the cohort and the country studied.~      To date, no study on these two viruses has been conducted in France to evaluate the~     circulation and the pathogenicity of these viruses in subjects with diarrhoea.~      The aim of this study is thus to:~        -  show that these viruses are in circulation in France in infants younger than 5 years~          old and that the proportions are similar to those reported in the literature.~        -  confirm the relationship between the diarrhoea and the infection with these viruses.~   "
15618|NCT02852863|"~     To identify by ultrasound the possible changes in gastric volume and content after chewing~     gum for an hour in volunteers with complete fasting (more than 8 hours).~   "
14824|NCT02863250|"~     Severe and unstopped blood loss can occur for a number of different reasons including after~     a serious injury, delivery of a baby and following other medical and surgical emergencies.~     The investigators understanding of how to best treat people with serious bleeding is still~     incomplete, with many questions remaining. These include questions regarding how many people~     have serious bleeding events, what happens to them and the best way to treat them.~      The Massive Transfusion Registry (MTR) is a register of patients who have experienced major~     blood loss that required a massive transfusion in any clinical setting.~      The MTR uses electronic data extraction and data linkage methodologies. Pre-existing~     clinical data from hospital data sources, including Laboratory Information Systems (for~     transfusion history and laboratory results) and Health Information Services databases (for~     Patient demographics and admission data), are electronically extracted by staff employed at~     the participating hospitals. The data is then sent to the MTR Research Team, located at~     Monash University, where it is then linked, analysed and stored.~      The establishment of a Massive Transfusion Registry will be a unique and important resource~     for clinicians in Australia, New Zealand and internationally, for Blood Services and for the~     broader community. It will provide valuable observational data regarding the types and~     frequency of conditions associated with critical bleeding requiring massive transfusion, the~     use of blood component therapy (i.e. ratios and quantities of different types of red cell to~     non- red cell components) and patient outcomes.~   "
14825|NCT02863237|"~     Brian injured patients are predisposed to various complications related to mechanical~     ventilation. Appropriate decision making of the weaning is crucial and validated predictive~     parameters are desirable. In present study, the investigators aim to a) validate the~     electrical activity of diaphragm (EAdi) derived parameters, and b) evaluate the traditional~     predictive parameters in weaning prediction in brain injured patients.~   "
14826|NCT02863224|"~     Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact~     pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is~     advancing age. The rate of ageing is not the same in all age matched individuals. The~     concept of accelerated ageing suggests that the presence of a number of specific genetic,~     environmental or systemic risk factors may cumulate to accelerate the ageing process in some~     individuals and lead to the development of age-related disease. Understanding the factors~     that influence accelerated ageing is vital.~      Advanced glycation end products (AGEs) are a complex group of compounds that are naturally~     formed. They accumulate gradually with age in cells, tissues and blood vessels throughout~     the body where they adversely affect structure and function. Circulating AGE levels can be~     influenced by oxidative stress levels and dietary intake. Recent research has found that~     sustained exposure to high levels of circulating AGEs could be a major factor in the~     development of a number of chronic age-related degenerative disorders, including POAG.~      To date there have been few clinical studies that have been able to non-invasively explore~     the association between AGE levels and the development and progression of glaucomatous optic~     neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary~     intake make to total tissue AGE levels in such patients. Furthermore little is understood~     about the relationship between AGE levels and retinal vascular function, a parameter known~     to be altered in GON that also could be influenced by AGE levels.~      The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with~     parameters of retinal vascular function, oxidative stress, dietary intake and the presence~     of GON. Establishing this association could increase our understanding of the pathogenesis~     of GON and allow a new biomarker for accelerated ocular ageing to be realised~   "
14827|NCT02863211|"~     Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus~     on traditional risk factors, such as age, gender, smoking status, blood pressure, and~     cholesterol; however, this approach does not directly assess cardiovascular function and~     underestimates the risk of experiencing adverse cardiovascular outcomes in women. This~     prospective, observational trial will examine the ability of the Heart Attack Prevention~     Program for You (HAPPY Hearts) screening protocol, a series of non-invasive procedures to~     identify middle-aged and older women who are at elevated risk for experiencing an adverse~     cardiovascular event in the five-year period after screening. The predictive value of the~     HAPPY Hearts protocol will also be compared to the Framingham Risk Score to determine if one~     method has better sensitivity for estimating risk for an adverse cardiovascular outcome.~   "
14828|NCT02863198|"~     One hundred and twenty women with unexplained infertility were included in the study.~     Divided randomly into two groups:~      Group I: (60 patients): (control group)~      Group II (60 patients): (study group)~      All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle,~     Doppler examination was performed to all patients. Also on day 5, but only for group (II)~     patients, local endometrial injury was performed. Doppler studies was repeated, for all our~     patients, on the same day of prescribing human chorionic gonadotropin~   "
14829|NCT02863185|"~     Patients with chronic kidney disease (CKD) are high risk for death and cardiac disease is~     the major cause of death. CKD patients commonly have traditional risk factors for coronary~     artery disease, such as age, gender, hypertension, cigarette smoking, and dyslipidemia.~     Previous studies have reported that reducing cholesterol levels is associated with reducing~     morbidity and mortality from atherosclerosis. In particular, pharmacologic treatment using~     statin has been decreased the risk of adverse cardiovascular events in CKD population.~     Therefore, guidelines recommended the use of statin in CKD patients. On the other hands,~     niacin or fibrates is not recommended concomitantly with statins in patients with CKD~     because of increased risk of adverse events. In addition, recent study has reported that~     there was no incremental clinical benefit from the addition of niacin to statin therapy, in~     further decreasing the incidence of major cardiac events.~      Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in~     patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be~     explained by anti-inflammatory, anti-oxidative, or anti-thrombic effects. In addition,~     omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid~     metabolism. The erythrocyte membrane content of FA has been shown to correlated with the FA~     content of the myocardium. The risk of cardiovascular disease is significantly reduced in~     patients with high omega-3 FA, such as eicosapentanoic acid or docosahexaenoic acid (DHA),~     in the erythrocyte membrane. In contrast, high levels of erythrocyte membrane total~     trans-FA, trans-oleic acid, and arachidonic acid (AA) are associated with an increased risk~     of cardiovascular disease. Erythrocyte membrane monounsaturated FA (MUFA) content, including~     oleic acid, is significantly higher in patients with acute coronary syndrome than control~     subjects. The erythrocyte membrane oleic acid content was also higher in dialysis patients~     who have high risks of cardiovascular disease compared to control subjects. Therefore, the~     modification of erythrocyte membrane FA content is very important with respect to~     cardiovascular disease. In a previous study, erythrocyte membrane omega-3 FA was shown to be~     increased and the MUFA content was decreased after omega-3 FA supplementation in HD~     patients. However, there are no reports about the effect of statin on the erythrocyte~     membrane FA composition in CKD. Recent study has reported that those with pitavastatin 4mg~     were decreased DHA to AA ratio, but those with pravastatin 20 mg were not change the DHA to~     AA ratio in patient with CAD. Statin may have important role on the modulation of~     erythrocyte membrane FA. In this study, the investigators hypothesized that pitavastatin~     supplementation can modify erythrocyte membrane FA content, including MUFA and oleic acid,~     in CKD patients. In addition, the investigators evaluated the effect of pitavastatin on~     adiponectin and glucose level in CKD patients.~   "
14874|NCT02862587|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using precision cells to treat~     Advanced Lung Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Lung Cancer.~   "
14875|NCT02862574|"~     The primary objective of this study is to evaluate the efficacy of GS-5745 versus placebo as~     an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with~     moderate to severe rheumatoid arthritis (RA).~   "
45490|NCT02461576|"~     Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA~     quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.~   "
14830|NCT02863172|"~     Objectives:~        1. To examine the variations in clinical features, survival outcomes, family history, and~          health behavior among proband patients who are known or suspected to have a hereditary~          colorectal cancer syndrome~        2. To compare the clinical features, survival outcomes, and health behavior of the proband~          vs. his/her family members who may or may not be affected by the hereditary colorectal~          cancer syndrome~        3. To explore for correlations between germline genetic variations in both the probands~          and family members with observed variations in the overall disease phenotype across~          probands and kindreds, within a given syndrome. Disease phenotype is defined to~          include: (1) clinicopathologic features including patient demographics and oncologic~          outcomes; (2) clinical manifestations of disease including the timing, spectrum and~          severity of CRC and extracolonic cancers. Genetic variations may include the specific~          codon mutated, the type of mutation and sequence alteration, chromosomal/gene copy~          number changes, and gene polymorphisms.~        4. To explore for correlations between germline genetic variations in both the probands~          and family members with observed variations in somatic CRC tumor biology, including~          tumor pathology and other tumor molecular markers~   "
14831|NCT02863159|"~     The objective of this study is to evaluate the uncorrected binocular distance, intermediate,~     and near visual acuities, and assess patient's spectacle independence and satisfaction in~     individuals undergoing bilateral cataract extraction that have received two different arms~     of near add design IOLs of the same diffractive multifocal model.~   "
14832|NCT02863146|"~     HALACAP-1406 is a prospective single-centre non-interventional study assessing the~     refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®)~     in the conditions of use specified in its marketing authorization. Eribulin will be used~     alone for the treatment of the patients having a locally advanced or metastatic breast~     cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.~   "
14833|NCT02863133|"~     The study is a prospective, multicenter, multinational study to assess the safety and~     performance of the Easyx (trade name) Antia Liquid Embolic during embolization of~     intracranial malformations and fistulas. The clinical trial will include patients already~     scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be~     required to collect the safety and performance data of the study material. Up to 65 patients~     will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be~     required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat~     brain arteriovenous malformations - AVMs or brain tumours. Only experienced~     neuroradiologists will be invited to participate in this study.~   "
14834|NCT02863120|"~     This study is being done to evaluate the outcomes of patients undergoing total knee~     replacement with two different methods of local pain control:shots of liposomal bupivacaine,~     a long acting anesthetic, directly into the knee during surgery or anesthetic delivered~     continuously to the adductor canal to provide long term pain relief. The goal is to try to~     find a standard protocol that provides the greatest pain relief for patients undergoing~     total knee replacement.~   "
14835|NCT02863107|"~     The goal of this laboratory research study is to learn more about genetic factors that may~     influence the risk for developing colorectal cancer at a young age.~   "
14836|NCT02863094|"~     To investigate the treatment effect of continuous transcranial magnetic stimulation on~     schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by~     functional MRI~   "
14837|NCT02863081|"~     Select Specialty, a national network of more than 100 LTACHs across the United States, has~     expressed the desire to adopt the ABCDEF bundle as a standard of care for its patients. As~     part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement~     project in one of its local hospitals. The overall purpose of this before-after study is to~     study prospectively the process and effects of implementing the ABCDEF bundle into the~     everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.~   "
14838|NCT02863068|"~     The investigators propose a Phase II study, prospective and placebo controlled, of a topical~     cream containing sodium nitrite compared to the current standard of care. Sodium nitrite is~     a local donor of nitric oxide, which is known to improve blood flow and decrease bacterial~     load in the ulcer bed. The primary objectives are to evaluate the safety of topical sodium~     nitrite cream treatment in patients with sickle cell disease and chronic leg ulcers and to~     determine its effectiveness in accelerating the healing process and decreasing the pain~     associated with ulceration.~      Potential benefit will be a durable resolution or improvement of the leg ulcer and its~     associated pain. Possible side effects include decreased blood pressure and~     methemoglobinemia, secondary to sodium nitrite absorption through the ulcerated skin.~   "
14839|NCT02863055|"~     This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with~     unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A:~     nintedanib and arm B:placebo~   "
14840|NCT02863042|"~     The investigator hypothesizes that primary acute ankle deltoid ligament repair can help~     restore ankle radiographic congruity and functional outcomes.~   "
14841|NCT02863029|"~     New studies are revealing how a high-fat diet could be making the cells of the intestinal~     lining more likely to become cancerous. The investigators would like to study how obesity~     influences growth of intestinal stem cells, which could then trigger intestinal tumors.~      The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants~     from each of two different BMI categories: 20-25 and 35 & above), who will be asked to~     provide blood, stool, & urine samples, undergo a flexible sigmoidoscopy, and complete food~     frequency questionnaires~   "
14842|NCT02863016|"~     The aim of this study was to evaluate the effect and timing of action on the inflammatory~     state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online~     postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of~     acetate ) in the medium term. In addition, the study will evaluate other parameters of~     efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to~     bone metabolism and vessel calcification in the medium term.~   "
14843|NCT02863003|"~     Retrospective and prospective cohort of patients with germ cell tumor in treatment.~   "
14844|NCT02862990|"~     To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of~     loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.~   "
14845|NCT02862964|"~     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are~     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This~     device uses sound waves to create pictures of the spine in three dimensions. This may allow~     the physician to view the spine in more detail for procedures such as spinal anesthesia and~     other diagnostic procedures.~      The investigators aim to assess the benefit of using the Accuro versus traditional landmark~     palpation technique to determine accurate spinal level for procedures. Patients who undergo~     interventional pain procedure per standard care under fluoroscopy and require the presence~     of an anesthesia provider at the UVA Pain Management Clinic will be approached for~     enrollment.~      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of~     palpating the iliac crests to estimate spinal level, which will be marked with a single dot~     from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5~     interspace and mark this point with two dots. Participants will then be taken into the~     fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on~     fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces~     that were marked using the palpation and Accuro techniques. The anesthesiology attending~     provider in the fluoroscopy suite will then confirm the true interspace position of these~     marks under fluoroscopy. It will then be recorded how many spaces off the palpation and~     Accuro techniques are from the intended L4/L5 level.~   "
14846|NCT02862951|"~     The specific aim is to attempt to quantify the amount and efficiency of sleep that~     parturients receive after placement of labor epidural analgesia.~   "
14847|NCT02862938|"~     This is a randomized, sham controlled, masked clinical trial of 60 study participants with~     glaucoma. Participants with a qualifying study eye will be randomized after screening and~     baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham~     surgery (control arm), and no explant will be required.~      An examination for safety will occur one day and one week following implant and periodically~     thereafter for 24 months post-implant. Based on the primary analysis of data at 6 months,~     patients in the control arm may be offered the NT-501 ECT implant at the 12 month time~     point.~   "
14848|NCT02862925|"~     This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian~     Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the~     intermittent auscultation protocols at KCMC, and to validate whether or not a handheld~     Doppler device can perform the fetal scalp stimulation test accurately.~   "
14849|NCT02862912|"~     This study aims to determine whether or not spinal anesthesia with the local anesthetic~     drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and~     results in faster discharge from the post-anesthesia care unit after surgery.~   "
14850|NCT02862899|"~     The investigator will study the possibility of in situ heating of the liquid containing the~     chemotherapy, so as to avoid the need for an external pumping system with its complexity,~     and its associated risks and costs.~      The use of a heating cable (prototype hereinafter called Thermowire, made by the company~     EFS, which is in charge of its development) was patented and tested in pigs in two studies~     that included 15 animals altogether (in 7 of which the heating cable was used). The aim of~     the first study was the purely safety aspects, while the efficacy to obtain hyperthermia,~     the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration~     of the chemotherapy were evaluated in a second study. The results obtained justify transfer~     to use in humans in the context of a clinical trial so as to obtain CE certification.~   "
14851|NCT02862886|"~     CHRONOLOGICAL DESCRIPTION OF THE STUDY~        1. Information provided to study participants~        2. Collection of written informed consent~        3. Harvesting of myometrial biopsies~        4. Creation of tissue explants using myometrial biopsies~        5. Stimulation of the explants with LPS~        6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative~          stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to~          prevent the appearance of oxidative stress and its consequences on tissues, as a~          complement to previous studies, is an additional argument for the clinical development~          of this class of pharmaceuticals in the management of threatened premature delivery and~          labour induction.~   "
14852|NCT02862873|"~     The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist)~     before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic~     arterial pressure (SAP).~      The expected results are a decrease in the frequency and severity of hypotension, thus~     leading to improved comfort for the mother and decreased maternal and foetal morbidity.~     Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation,~     with sometimes severe consequences for neonates.~      It has been established that episodes of hypotension alter foetal pH. Investigators~     therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a~     benefit for the infant.~      One of the objectives of this study is also to observe a decrease in the quantity of~     vasopressors used and thus to avoid the adverse effects of their use in high doses.~      The expected results are thus an improvement in haemodynamic stability during spinal~     anaesthesia for caesarean section.~      The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive~     Arterial Pressure) as the collection of haemodynamic data will allow greater precision with~     the continuous measurement of AP, as well as a study of maternal cardiac output.~   "
14853|NCT02862860|"~     As glycaemic variability on the one hand and hypoglycaemia on the other are associated with~     oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect~     the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic~     properties.~      The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will~     wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of~     hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions)~     associated with proatherogenic alterations in lipoproteins, in particular:~        -  LDL oxidation~        -  HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant~          capacity)~   "
14876|NCT02862561|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy~     to treat Advanced Gastric Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Gastric Cancer.~   "
14855|NCT02862834|"~     In the context of this study, the investigators wish to take advantage of high-throughput~     genetic techniques (microarray and high-throughput exome sequencing) to identify new genes~     implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these~     syndromes, opportunities for genetic counselling for patients and their families and the~     follow-up of patients, notably with regard to the risk of tumours.~      This study will make it possible to identify new genes implicated in syndromic poikiloderma~     and improve the diagnostic strategy proposed to patients with these syndromes, and to~     propose to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the~     risk of tumours, genetic counselling to families and eventually an antenatal diagnosis to~     couples who would like to have one for future pregnancies.~      The identification of new genetic causes of syndromic poikiloderma will also make it~     possible to complete the current classification of these syndromes~   "
14856|NCT02862821|"~     The purpose of this study is to identify alterations of motivational processes related to~     decision making in uncertainty condition associated with gambling addiction: by studying the~     dynamics between brain systems involved in decision making and motivation.~   "
14857|NCT02862808|"~     Evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated~     severe intellectual disability without a molecular diagnostic, with suspected autosomal~     recessive inheritance, allowing accurate genetic counseling in this high risk of recurrence~     group of diseases~   "
14858|NCT02862795|"~     Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions.~     Little is known about HPV carriage in anal canal previous to cancer occurrence in the~     population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective~     study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence~     in anal canal in a population non selected by its HIV status. In that purpose patients are~     prospectively recruited in a french university hospital gastroenterology unit and anal~     smears are collected during a colonoscopy with cytobrush.~   "
14859|NCT02862782|"~     Background~      The trigger for the final maturation of the ovum by providing integration of Human Chorionic~     Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced~     long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF~     treatment.~      In a recently published work which compared two types of ovulation induction (standard dose~     of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was~     a statistically significant increase in the rates of implantation, clinical pregnancies and~     live births rates by providing integration of hCG and GnRH agonist.~      To conclude, providing GnRH agonist in combination of hCF in standard dose is today an~     accepted treatment for final maturation of the ovums.~      OBJECTIVE~      The investigators objective is to investigate whether providing integrated treatment of~     Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to~     final maturation of the ovum can improve the quality of the embryos, clinical pregnancies~     and live births rates in women treated with GnRH Antagonist protocol.~      The main objective is to compare between two existing treatments.~   "
14860|NCT02862769|"~     The aim of this study is to evaluate the impact of intravenous lidocaine on acute and~     chronic post surgical pain on patients undergoing video assisted thoracoscopic~     surgery(VATS). The investigators believe that systemic administration of lidocaine during~     the perioperative period would be effective in preventing chronic pain post VATS. In~     addition to chronic pain the investigators believe it will reduce acute postoperative pain~     as well as each patients total opioid requirement.The investigators believe that this will~     have a significant impact on the care of patients presenting for VATS.~   "
14861|NCT02862756|"~     Endovascular treatment of ruptured and unruptured intracranial aneurysms presents~     complications, mainly the thrombo-embolic complication. No specific studies have been~     conducted to study factors associated with the occurrence of thromboembolic complications~     (symptomatic or not) post endovascular treatment of intracranial aneurysms.~   "
14862|NCT02862743|"~     Analysis of somatic mutations in tumors is currently indicated for daily practice in all~     metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers~     validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in~     some cases it requires invasive biopsies.~      In this context, molecular characterization of a tumor material flowing (circulating tumor~     DNA and / or circulating tumor cells) could afford to benefit patients in the best~     conditions of current targeted therapies and future.~   "
14863|NCT02862730|"~     Closed-loop systems are an emerging technology that automate hormone delivery. They are~     quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories~     have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop~     systems with insulin only, one variety of which is the low glucose suspend safety feature~     now available from Medtronic (MiniMed 530G with Enlite). The study described within this~     protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood~     glucose in people with type 1 diabetes before and after exercise. The new algorithm will~     have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode~     and an insulin only mode with predictive low glucose suspend, all with an exercise detection~     algorithm. The purpose of this study is to determine whether a dual hormone AP with an~     exercise detection algorithm outperforms both single hormone AP and a low glucose suspend~     algorithm and current care using the subject's own insulin pump.~   "
14877|NCT02862548|"~     The primary objectives of this study are to evaluate the safety, tolerability, and efficacy~     of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing~     regimens in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or~     greater chronic kidney disease who have received a liver transplant.~   "
14878|NCT02862535|"~     The primary objective of this study is to characterize the safety and tolerability of~     GS-5745 as monotherapy and in combination with S-1 and cisplatin chemotherapy in Japanese~     participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal~     junction (GEJ) adenocarcinoma.~   "
14879|NCT02862522|"~     Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the~     association with inflammation and coronary microvascular endothelial dysfunction is not~     well-defined. The aim of this study was to determine the relationship of serum uric acid,~     inflammatory markers and CED.~   "
14864|NCT02862717|"~     End-stage renal disease represents a major problem for public health, and is a severe~     disease affecting hundreds of millions of people in the world and increasing rapidly. It~     brings about complex implications to social and economic structures of every nation.~     Providing renal replacement therapy including , peritoneal dialysis and renal transplants~     for ESRD patients are resource intensive. Possible options have been proposed to ease the~     burden include early medical intervention to slow the progression of chronic kidney disease~     in high-risk patients, promotion of renal transplantation, and use of the most~     cost-effective dialysis therapy without compromising outcome. In Malaysia, despite growing~     financial pressure in health care system, cost-effectiveness studies of RRT modalities are~     scarce.The prevalence of ESRD patients on dialysis are approximately 34, 767 as of 2014 and~     expected to rise significantly in the foreseeable future. Thus, the sustainability of~     dialysis therapy is uncertain. This study aimed to assess the cost utility of hemodialysis~     and continuous ambulatory peritoneal dialysis treatment from Malaysia Ministry of Health~     perspective. One hundred and eighty patients will be recruited from five state hospitals via~     National Renal Registry. Patients' resource utilization including overhead costs,~     medications, dialysis consumables and hospitalizations will be recorded using specially~     designed case report form. Patients' quality of life will be assessed using validated~     EQ-5D-3L questionnaire. Survival analysis will be conducted based on NRR data. Next, a~     hypothetical cohort Markov model will be constructed to assess the cost utility of HD and~     CAPD using varying levels of CAPD use versus current practice. The data collection period is~     from 1st October 2016 to 30th September 2017. Incremental cost effectiveness ratio is the~     primary outcome of this study.~   "
14865|NCT02862704|"~     The purpose of this study is to collect the data on the safety and potential effectiveness~     of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver~     metastases expressing MG7 positively.~   "
14866|NCT02862691|"~     The goal of this study is to compare the speed and adequacy of pain relief in Emergency~     Department patients with a toothache after an oral analgesic or a local anesthetic~     administered as a nerve block or by local infiltration.~   "
14867|NCT02862678|"~     Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part~     of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI)~     is a non radiating imaging, not requiring injection of gadolinium, giving informations on~     tumor activity, based on the brownian motion of water molecules. The differences in motion~     are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect~     changes in water molecules motion and redistribution between the intra- and extracellular~     compartments. Several studies have shown that malignant lesions have an ADC coefficient~     lowered as compared to benign lesions.~   "
14868|NCT02862665|"~     In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products~     transfusions are often necessary to control intraoperative and postoperative bleeding.~     Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before~     surgery, and patients with normal hemoglobin level may become anemic during and/or after~     surgery. Perioperative transfusion carries risks far beyond transmission of infection and~     has been demonstrated to be associated with adverse outcomes related to postoperative~     pulmonary complications, decreased renal function and increased mortality. Thus, the~     important of blood conservation stratigies to minimize transfusion is being increasingly~     emphasized. In recent trial by Johansson and colleagues, they concluded that the~     perioperative administration of intravenous iron isomaltoside 1000 increased the hemoglobin~     level and prevented anemia 4 weeks after cardiac surgery. Therefore, perioperative iron~     isomaltoside 1000 administration among the patients undergoing complex valvular heart~     surgery could reduce not only the perioperative allogeneic transfusion but also the~     incidence of postoperative adverse events. The aim of this study is to examine the effect of~     perioperative iron isomaltoside 1000 administration on transfusion requirements in patients~     undergoing complex valvular heart surgery.~   "
14869|NCT02862652|"~     Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic~     strategies allow healing of over 80% of children. However these treatments are associated~     with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during~     treatment initiation, are the thromboembolic complications.~      The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy~     used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no~     efficacy in the prevention of these thromboembolic complications. Therefore most authors~     consider that a multifactorial mechanism is behind these events, involving both treatment~     and malignant cells. The interaction of these two factors participate in the damage of the~     vascular endothelium.~      The microparticles are membrane fragments derived from budding from the membrane of~     activated cells or apoptosis. Their thrombogenic role is linked to the expression of~     coagulation activators such as tissue factor. It is also associated with their role in the~     modulation of signaling pathways involved in the invasiveness and angiogenesis in~     endothelial cells.~      In acute lymphoblastic leukemia, the presence and role of microparticles have not been~     studied. Our hypothesis is that of production of microparticles upon lysis of blasts then~     upon activation of endothelial cells induced by the induction therapy, participating in a~     procoagulant phenotype.~   "
14870|NCT02862639|"~     The current management of osteoarthritis is based on non-pharmacological and pharmacological~     means which include intra-articular injections.~      The recommendations on the management of hip osteoarthritis stipulate that intra-articular~     injections of corticosteroid may be considered in patients with an exacerbation not~     responding to oral treatments. Several recent studies show the effectiveness of~     intra-articular corticosteroids compared with anesthetics. The intra-articular injection of~     viscosupplementation alone has never been validated in this indication since controlled~     studies did not show efficacy over placebo. At present, viscosupplementation is considered~     an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in~     hip osteoarthritis.~   "
14871|NCT02862626|"~     The incidence of type one diabetes is still rising, especially in children under 5 years~     old. Mothers often are the primary caregivers of these children. To take care of a young~     child with diabetes is a great responsibility and mothers must be constantly vigilant. This~     study aims to assess the psychological state of these mothers (in term of depression,~     anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.~   "
14872|NCT02862613|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With~     TACE in Advanced Liver Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Liver Cancer.~   "
14873|NCT02862600|"~     The purpose of this study is to evaluate the effect of perhexiline on exercise performance~     (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe~     heart failure following dosing for 16 weeks.~   "
14880|NCT02862509|"~     o Chronic rhinosinusitis is one of the most common health issue affected American~     population. Surgery plays an important role in the patients who failed the medical~     treatment. The most difficult location to be operated endoscopically is the frontal sinus.~     Frontal sinus is also found to be one of the most common sinus for residual and recurrence~     after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus~     surgery cares. The topical therapy can be delivered by many approaches. According to the~     standard clinical practice guideline and recommendations, intranasal corticosteroid spray is~     suggested. The technique proved to have greater distribution than standard intranasal spray~     is instillation of steroid nose drops. The head position for instillation of steroid nose~     drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor~     position.~   "
14881|NCT02862496|"~     The purpose of the study is to determine whether maternal bone resorption would be seen in~     Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels,~     serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels~     in the patients with Hyperemesis Gravidarum.~   "
14882|NCT02862483|"~     The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower~     urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a~     randomized, double blinded, parallel design, active controlled, multi-center, phase 3~     clinical trial~   "
14883|NCT02862470|"~     The investigators expected to enroll 30 patients with papillary, follicular or anaplastic~     thyroid cancer, and collect their urine samples before operation, immediately after~     operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal~     proteins and probable biological markers. The investigators hope to find the prognostic~     biological markers via this prospective study. The investigators further hope to find newly~     therapeutic mechanism and medications for such patients with poorly-differentiated or~     anaplastic thyroid cancer.~   "
14884|NCT02862457|"~     This is an open-label, non-randomized, Phase I study of MK-3475 (pembrolizumab) and~     INCB024360 (epacadostat) in participants with advanced solid tumors. The primary objective~     of the trial is to evaluate the safety and tolerability of INCB024360 administered alone and~     in combination with MK-3475.~   "
14885|NCT02862444|"~     Postpartum depression (PPD) is a highly prevalent and serious mental health problem and is~     defined as the most recent episode of depression occurring between four weeks and twelve~     months after childbirth. PPD has negative effects, which are usually strongest during the~     first six months and may decrease the quality of mother-child interaction, adversely~     affecting the child's behavior and emotional and cognitive development, as well as the~     spouse marital relationship.PPD prevalence is estimated at 10 to 20%. A recent studies among~     Arab-Bedouin women, reported 31% - 43 of PPD.~      Aims: To develop and implement a culturally appropriate intervention program by using focus~     group (FGs) methodology~      Methods and Research program description: The study includes two phases. First, qualitative~     study will be conducted by using focus groups (FGs) method and based on the results of this~     phase we will develop a culturally based program. The second phase will include~     implementation and evaluation of the effectiveness of a culturally appropriate intervention.~   "
14886|NCT02862431|"~     The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult~     Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.~   "
14887|NCT02862418|"~     This research study has 2 purposes:~        1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer~          pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as~          well as traditional MRI.~        2. To collect images and health information about lungs that have different kinds of lung~          diseases to compare to healthy lungs. This collection will help researchers and~          clinicians to better understand lung variations in health and disease.~      This study will involve one MRI session that will take about 10 to 30 minutes and for some~     participants a breathing test that measures how well the lungs are working. This test is~     called spirometry.~   "
14888|NCT02862405|"~     The loss of central vision causes difficulty not only in reading but also in faces~     recognition, and in particular in the identification of facial expression, objects or~     spaces. These visual deficits have been mainly studied in relation with reading, which is~     the main complaint of these kind of patients. However, there are not enough data regarding~     perception of objects and spaces in this population. Then, the objectives are to study the~     visual-spatial abilities in individuals with vision loss, and altered cognitive processes,~     (2) to develop clinics tools for early detection and quantification of visual-spatial~     deficits and (3)to understand the capacities of normal peripheral vision in order to test~     the possibility of potential training for use of peripheral vision when central vision is~     impaired by an ophthalmic pathology.~   "
14889|NCT02862392|"~     The hypothesis of this study is that progressive AIS is characterized by a disorder of~     orthostatic postural control. The analysis and the treatment of posturographic signal on~     computerized integrate force plates, coupled to clinical and radiographic examinations,~     could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could~     help the clinician in his therapeutic approach, based on the postural control improvement~     (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by~     corset). This method is non-invasive, without side effects, fast and achievable in routine~     care at the moment of the diagnosis of AIS.~   "
14890|NCT02862379|"~     The risk of falling affects more than one third of people over 65 years old and over 50% of~     persons over 80 years. These falls have important consequences for the autonomy of the~     elderly patient and also increase the risk of sequelae and death.~      The goal of this study is to evaluate a personalized rehabilitation program for elderly~     patients that fall for the first time and to measure the impact on the fear of falling of~     these patients. This intervention is a home-based program combining exercises, home~     modifications and education on fall risk factors.~   "
14922|NCT02861950|"~     This is a prospective randomized multi-center non-inferiority trial conducted through the~     Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the~     incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair~     compared with penile nerve block.~   "
15619|NCT02852850|"~     Molecular imaging with infliximab antibody with FITC has the potential to predict~     therapeutic responses to infliximab antibody and can be used for personalized medicine in~     ulcerative colitis.~   "
14891|NCT02862366|"~     Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such~     as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF)~     have a higher risk of arterial or deep-vein thrombosis. This is responsible for a~     significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular~     inflation and blood hyperviscosity, resulting from these diseases, fail to account for these~     thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic~     drug treatment.~      These last years, cellular microparticles (MPs) have been shown to play a major role in~     thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells,~     platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller~     than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as~     support for the coagulation factors. Increase in the plasma concentration of procoagulant~     platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary~     syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that~     platelet microparticles are involved in the hypercoagulability of MPNs patients.~   "
14892|NCT02862353|"~     The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from~     a peripheral destruction of platelets in the presence of the drug only. They usually involve~     immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein~     or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The~     most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory~     drugs or anticonvulsants but the list is not exhaustive.~      in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM~     is suspected but the offending drug is difficult to identify in generally poly-medicated~     patients.~      Several drugs may be suspected and the clinician uses biology for rapid assistance to the~     de-prescription and reduces unnecessary therapeutic substitutions in an always difficult~     clinical situation.~      The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a~     biological test of thrombocytopenia induction in the presence of the drug and the patient's~     serum that is to say its antibodies and complement fractions with cytometry reading flow.~     This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in~     hospital laboratories. But this test must be validated on well-documented clinical cases.~      The purpose of this pilot project is to validate the technical and assess the clinical~     specificity of the test TITIM for hard imputability drugs validated by a committee of~     experts combining a posteriori of clinical and biological criteria of routine.~   "
14893|NCT02862340|"~     Autism, ranked among the '' pervasive developmental disorders' (ASD), is characterized by~     disturbances in the areas of reciprocal social interaction, communication and behavior,~     interests and activities restricted, repetitive. Various studies indicate that autistic~     disorder is subjected to a genetic predisposition, most likely polygenic and heterogeneous.~     However, no major gene responsible for this disorder has yet been identified. Given the link~     between the Fragile X syndrome (the most common form of mental retardation (MR) hereditary)~     and autistic behavior, it seems interesting to look, also, a possible link to the molecular~     level. Among the proteins interacting with FMRP (absent protein in fragile X patients), the~     investigators were interested to CYFIP1, protein encoded by the gene CYFIP1 appears to be a~     good candidate gene involved in the RM and autism by its chromosomal position and function.~     As FMR1, CYFIP1 is expressed in the brain cortex, hippocampus and Purkinje cells of the~     cerebellum. This protein co-localizes and interacts with Rac and FMRP, which are both~     involved in neurogenesis and cognitive development. In humans, the gene encoding CYFIP1 is~     located in the 15q11-q13. Now, the only autosomal abnormalities most frequently observed in~     autism are those involving the proximal 15q region, including duplications or 15q11-q13~     triplications interstitial, of maternal origin.~      These data suggest that an / or more autism genes responsible are probably present in the~     15q11-q13 chromosomal region, although no gene has yet been identified. Thus, the study of~     the role of CYFIP1 gene in patients with autism spectrum disorders would most likely~     contributory.~      The investigators wish to study the involvement of the 15q11-q13 chromosomal region and~     CYFIP1 gene in autistic disorder in a hundred patients from the Autism Resource Centre (ARC)~     Nice PACA antenna, over a two year period.~      The diagnosis and assessment report of children likely to be included in this study will be~     conducted at ARC Nice. Balance sheets are made according to the recommendations of the High~     Authority of Health for diagnosis of infantile autism and PDD. These children are then sent~     to the Genetic Consultation Nice Hospital where an analysis of the background and a specific~     morphological examination will be realized..~   "
14894|NCT02862327|"~     Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged~     postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after~     ultrasound guided axillary brachial plexus block~   "
14895|NCT02862314|"~     There is actually no consensus in place defining for which patients with suspected~     inhalation pneumonia antibiotic treatment should be initiated and what the duration of this~     antibiotic treatment should be.~      This absence of recommendations results in excessive use of antibiotics, in emergence of~     multi-resistant strains and increase of costs. Several studies have been performed~     investigating antibiotic treatment based on procalcitonin values and have demonstrated a~     decreased use of antibiotics without change in mortality rates, in duration of~     hospitalization, in occurrence of super-infections or in infection relapse rate. Of the~     studies performed in an intensive care setting, none has specifically studied inhalation~     pneumonia.~      The objective of this study is to determine whether use of a decisional algorithm based on~     procalcitonin values allows reducing antibiotics exposure in patients who are intubated~     because of coma in comparison with standard care according to actual guidelines and clinical~     experience with respect to ventilator-acquired pneumonia.~      The study has a prospective, multi-centre, comparative, randomized, open design. It is a~     superiority study, with as primary parameter the duration of antibiotic therapy during the~     first 15 days after admission in the intensive care unit (ICU).~      Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale~     (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration~     of ventilation exceeding 48 hours.~      There will be two treatment groups, stratified by centre and randomised in blocs of 4: one~     group for which treatment initiation and discontinuation will be guided by a~     procalcitonin-based decisional algorithm and a control group to whom antibiotics will be~     administered according to the standard protocols of each participating centre.~      Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α~     level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the~     treatment arm guided by procalcitonin values, the number of patients to be included is 83~     per treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166~     patients should be included.~   "
14896|NCT02862301|"~     The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral~     blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group)~     and healthy controls (control group).~   "
14897|NCT02862288|"~     The aims of this work were to assess the feasibility, efficacy, short-term outcome and~     safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.~   "
14898|NCT02862275|"~     This phase I trial studies the side effects of atezolizumab in treating patients with cancer~     following adoptive cell transfer. Monoclonal antibodies, such as atezolizumab, may interfere~     with the ability of tumor cells to grow and spread.~   "
14899|NCT02862262|"~     A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection~     and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B.~     parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical~     specimens; banked, pre-selected clinical specimens; and contrived specimens.~   "
14900|NCT02862249|"~     Patients with advanced cirrhosis have enteric dysbiosis with small bowel bacterial~     overgrowth and translocation of bacteria and their products across the gut epithelial~     barrier. This culminates in systemic inflammation and endotoxemia which induces innate~     immune dysfunction predisposing to infection and development of complications such as~     bleeding, sepsis and hepatic encephalopathy. It also plays a key role in the natural history~     of cirrhosis by influencing the rate of progression to advanced liver disease and terminal~     liver failure.~      The investigators propose an intervention utilising Faecal Microbiota Transplantation (FMT)~     from a healthy donor to modify the gut microbiome alleviating gut dysbiosis and immune~     dysfunction. This may ultimately reduce the progression to chronic liver failure and the~     development of infection and organ dysfunction.~      The primary objective of this study will be to assess whether stabilising gut dysbiosis with~     FMT in patients with advanced cirrhosis is both feasible and safe.~   "
14901|NCT02862236|"~     The experiment is aimed to examine the effect of common psychiatric drugs on several~     cognitive functions, in a healthy and subclinical adult population. The investigators~     hypothesize that baseline stress level regulates drugs effects on cognitive performance.~     Additionally, different levels of stress may moderate the drugs-cognition relations. In~     order to examine our hypotheses, the investigators focus on two anxiolytic drugs: herbal~     based (Hypericum) and benzodiazepine (Alprazolam). about 160 healthy (and/or subclinically~     anxious) subjects (aged 18-40) will be administered with single dose of the drugs (between~     subjects) on two different experiment dates - so subject that will be administered with a~     drug will receive placebo on the second date, or vice versa. The design will be double blind~     and second experiment day will occur at least 14 days after the first. Prior to~     administration, the investigators will measure depression and trait anxiety and state stress~     and anxiety, using inventories and cortisol in saliva test. Subjects will undergo a battery~     of computerized cognitive tests measuring working memory, attention, executive control,~     visual perception and long term memory. State anxiety and stress will be also measured~     before and after the battery. A gentle stress manipulation will be conducted during some of~     the tests.~   "
14902|NCT02862223|"~     This open-label study investigated the effectiveness of Neprinol on maintaining healthy~     cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per~     day over a period of 12 weeks.~   "
14903|NCT02862210|"~     Frontotemporal dementia (FTD) is a progressive neurodegenerative illness that affects the~     frontal and anterior temporal lobes of the brain. Changes in behavior, including agitation,~     aggression, and repetitive behaviors, are common symptoms in FTD. The investigators~     currently do not have good medications to treat these symptoms in FTD, and the medications~     the investigators use often have side effects. In this project, the investigators will test~     the use of low-dose lithium, compared to a placebo pill, for the treatment of behavioral~     symptoms in FTD. Lithium greatly reduces the behavioral symptoms of bipolar disorder, and~     many have found low-dose lithium to be well-tolerated in patients with dementia. Lithium~     appears to inhibit the creation of a protein involved in many cases of FTD called tau.~   "
14904|NCT02862197|"~     The purpose of this study is examine whether invasive pulmonary artery pressure (PAP)~     monitoring could be beneficial for the patients in dialysis treatment. Ten implantable~     pressure sensors (CardioMEMS ®) will be implanted and the PAPs of the individual~     participants are recorded during and in between the routine dialysis treatment sessions.~     This is an exploratory pilot study, where major interest lies in the values and changes in~     PAP in relation to other hemodynamic parameters among patients in dialysis treatment.~     Implanted device is only monitoring the patient without any effect on the actual treatment.~   "
14905|NCT02862184|"~     Many women will likely experience a sexual problem in their lifetimes. The Prevalence of~     Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking~     (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual~     function. Results from this study estimated that 12% of women experience a diagnosable~     sexual disorder that causes personal distress, with lack of sexual desire being the most~     prevalent. - See more at:~     http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf~   "
14906|NCT02862171|"~     A follow-on, open label trial to assess continued safety of and adherence to the~     Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women~   "
14907|NCT02862158|"~     This is a single center, prospective study to evaluate the efficacy and reproducibility of~     frequency doubling technology (FDT)-based visual field devices compared to conventional~     Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this~     study.~   "
14908|NCT02862145|"~     This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics~     of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with~     easily accessible lesions will undergo serial biopsies and serial blood samples will be~     collected.~   "
14909|NCT02862132|"~     Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7~     integrin which modulates lymphocyte trafficking in the gut.~      Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in~     induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease~     (CD), respectively.~      Recent real life cohorts in adults support the effectiveness of VDZ in inducing and~     maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the~     use of VDZ besides two retrospective case series.~      Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults~     and practically non-existent in children.~      The investigators aim to prospectively explore the real life short and longer term outcomes~     of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment~     success based on VDZ trough levels and other clinical and laboratory variables.~   "
14923|NCT02861937|"~     Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and~     chronic periodontitis. A significant increase in the concentration of IL-21 in gingival~     crevicular fluid is observed with an increase in the amount of periodontal destruction. Non-~     surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis~     and chronic periodontitis~   "
14924|NCT02861924|"~     Measure microcirculatory responses after localized ischemia obtained by local application of~     pressure (laser speckle).~   "
14910|NCT02862119|"~     Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with~     multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the~     infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still~     not well established. Current guidelines recommend PCI of only the infarct related artery~     (IRA). However, recent small scale randomised controlled trials indicate that full~     revascularization of these non-infarct related arteries during the index procedure is~     superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to~     determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI~     in stable angina.~      Objective and methods: To test the hypothesis that a strategy of systematic complete~     revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to~     improved clinical outcomes at one year compared to initial conservative management of~     non-culprit lesions. The trial is a prospective international multicentre registry-based~     randomized controlled trial with combined primary endpoint of all-cause mortality and~     non-fatal MI at one year. Key secondary endpoint is unplanned revascularization. 4052~     patients with acute STEMI/very high risk NSTEMI with multi-vessel disease in Sweden,~     Denmark, Norway, Finland, Iceland, Latvia and Poland will be randomized into 2 arms:~        1. FFR-guided PCI of non-culprit lesions during index hospital admission or~        2. Initial conservative management following acute PCI of the culprit lesion(s) or~      Randomization and data collection in the registries - the Swedish Coronary Angiography and~     Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic~     data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events~     at a low cost. Adjudication of clinical events and collection of data from other registries~     including death cause registries is also planned.~      Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very~     high risk NSTEMI improves clinical outcome compared to conventional management this will~     change practise in how we should best manage these patients. Therefore a study of this size~     will definitely be of great importance in determining future guidelines for this large~     patient group to reduce both morbidity and mortality.~   "
14911|NCT02862106|"~     The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based)~     treatment in chronic hepatitis B patients and to explore the most effective dosage and~     provide the rational for optimal dosing schedule.~   "
14912|NCT02862093|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex~     may affect neuro-adaptations associated with alcohol use disorder (AUD), potentially~     influencing craving and alcohol intake.~      Investigators investigated alcohol intake and dopamine transporter (DAT) availability by~     Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before~     and after deep rTMS.~   "
14913|NCT02862067|"~     To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory~     fitness in patients with systolic heart failure.~   "
14914|NCT02862054|"~     To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic~     lymphohistiocytosis (HLH) in patient with unknown etiology.~   "
14915|NCT02862041|"~     In this prospective, randomized, double blinded study, the needle tip and needle shaft~     visibility of echogenic and nonechogenic needle were compared in ultrasound guided~     infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery~     were included in the study. Patients were randomised into two groups, group E (Echogenic)~     and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance~     infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic~     needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The~     subjective assessment for needle tip/shaft visibility as scored by the performer and the~     objective assessment from the recorded block procedure video were noted.~   "
14916|NCT02862028|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat~     relapsed or refractory cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with relapsed or refractory cancer that has not responded to or~     has relapsed after standard treatment.~   "
14917|NCT02862015|"~     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their~     quality of life have seriously deteriorated. There have been a few studies that showed an~     effect for pain control by hyperthermia (heating the patient's body). However, there are~     several limitations in conventional hyperthermia.~      In a previous pilot study (NCT02150135), we found the improvement of quality of life,~     function, and symptom.~      From this background, the investigators tried to show the effect of Oncothermia with~     conventional chemotherapy for pain control, increasing quality of life, and anti-tumor~     treatment.~   "
14918|NCT02862002|"~     A first empirical evidence on the difficulties of observance of morphine in cancer patients~     invited a multidisciplinary team to initiate an innovative quality approach. It shows the~     lack of transcript of a comprehensive care causing a problem for monitoring actions~     undertaken for the relief of pain. In addition, two exploratory studies targeting the~     expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong~     opioids.~      The E.T.P, public health priority, provides a framework for action and improving care. In~     oncology, the involvement of the patient in pain relief and management of opioids represents~     an axis of intervention more appropriate. Yet, it is not found in literature. In our~     department, we conduct an experimental therapeutic education program type caratif and a~     nurse consultation FTE receiving opioids on the model of nursing care of J. Watson~     (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient~     experience). The ETP folder and its tools have been continuously validated with patients.~     The heart of the educational process is in the patient's complex path neat oncology and~     relies on interaction and creativity between patient and caregivers.~   "
14919|NCT02861989|"~     Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high~     mortality in the elderly. Despite numerous programs aiming at improving OP care, the~     prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are~     multiple, both in the general and at-risk population, and in medical practitioners. Since~     they do not perceive their susceptibility to OP, people do not see the benefit of~     prevention. In addition, physicians do not give sufficient importance to OP prevention and~     care, despite the existence of guidelines.~      The investigators implemented a qualitative study to explore the knowledge and~     representations regarding osteoporosis in the general and at-risk population and in doctors~     in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured~     face-to-face interviews with general practitioners. Understanding barriers to osteoporosis~     care in patients and general practitioners will help to set up effective strategies to~     improve prevention and treatment.~   "
14920|NCT02861976|"~     The current study seeks to begin the crucial work of creating effective protocols to prevent~     opioid addiction and overdose by developing and pilot testing an opioid risk screening~     protocol at Wisconsin trauma centers.~   "
14921|NCT02861963|"~     The aim is to compare effective growth true hypoplastic pulmonary arteries using Right~     Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and modified~     Blalock-Taussig shunt~   "
14925|NCT02861911|"~     Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized~     by progressive weakness and atrophy of specific skeletal muscles. One of the major problems~     of patients affected by FSHD is the limitation in performing daily activities induced by the~     progressive muscle weakness. This sedentary lifestyle can cause a debilitative cycle, and~     neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies~     have indicated the safety and the effectiveness of moderate aerobic training programs in~     patients with FSHD. However, these training programs have limited applicability in patients~     with more severe muscular weakness. Artificial strength training by means of neuromuscular~     electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD~     patients suffering from neuromuscular disorders. Therefore we propose to investigate the~     feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps~     muscle weakness in patients affected by FSHD.~   "
14926|NCT02861898|"~     Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically~     treated by surgery, radiation therapy and chemotherapy, either individually or in~     combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate~     for brain cancer patients, with median survival at approximately 12 months. Glioma is the~     most common form of primary brain cancer, afflicting approximately 7,000 patients in the~     United States each year. These highly malignant cancers remain a significant unmet clinical~     need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor)~     which is blocked by Cetuximab (CTX). The investigators have recently completed a separate~     Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX~     after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in~     revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of~     CTX is well tolerated with few adverse effects. The investigators hypothesize that in~     patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and~     efficacious for our patients when combined with standard chemoradiation (STUPP protocol).~      This trial will be a non-randomized open label Phase I/II clinical trial. In addition to~     standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX~     intra-arterially after BBBD for a total of three doses at approximately post surgery days~     30, 120 and 210.~   "
14927|NCT02861885|"~     There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently~     identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a~     new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would~     be faster than through the usual adenoma to cancer way. It would be then responsible of a~     lot of missed lesions or interval cancer. The missed SSL rate is estimated at between 27%~     and 59%.~      Current diagnosis methods show weakness to identify those SSL. In order to improve their~     detection, the investigators dispose of several coloration techniques. Indigo carmine~     chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal~     carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any~     efficacy on the adenoma detection rate, except for patients with Lynch syndrome.~      The objective is to better describe the SSL endoscopic semiology (detection and~     characterization) and to establish standards for the endoscopic techniques in order to~     improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2~     fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely~     used for other indications, in comparison with the White Light technique (WLI).~      Therefore, the investigators propose a prospective, observational, multicentric cohort study~     in order to 1) define SSL endoscopic various aspects 2) establish which technique (white~     light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL,~     namely detection and characterization 3) evaluate the multifocal dimension rate for those~     lesions at ascending colon level.~      The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic~     NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic~     diagnosis. Better SSL detectability thus their systematic resection could have a long term~     effect in reducing both colon cancer rate and interval cancer~   "
14928|NCT02861872|"~     Ovarian cancer is the third most common gynecological malignancy worldwide. Because of late,~     aspecific symptoms, the disease is usually diagnosed at an advanced stage. Most patients~     experience recurrence and die as a result of the disease within 5 years. Treatment is a~     combination of surgical debulking and systemic administered chemotherapy. Intra-peritoneal~     (IP) chemotherapy with is currently considered the most effective treatment. In patients~     with at least an optimal surgical debulking, this leads to an improvement in life expectancy~     from 50 to 66 months. IP administration of chemotherapeutic agents is still not common~     practice. Furthermore recent studies revealed that cancer cells express a variety of tumor~     antigens, which can be targeted by the immune system. Also ovarian cancer shows evidence of~     a role for the immune system in clinical outcome. Novel insights into the mechanism of~     action of chemotherapy indicate that the efficacy of chemotherapeutic interventions are~     dependent on the modulation of the immune system. The impression exists that since IP~     chemotherapy is used, relatively more recurrences outside the abdominal cavity are observed.~     As of yet, no studies have described pharmacokinetics and pharmacodynamics of IP~     administered cisplatin and paclitaxel in the blood circulation. The investigators propose to~     study the use of this aspiration fluid from the IP cavity as a biomarker for the efficacy of~     chemotherapy intervention, monitor the effect of chemotherapy on IP tumor cells in the~     peritoneal cavity and monitor the effect of chemotherapy on immune cells present in the IP~     cavity. As well the investigators propose to correlate the presence and amount of tumor~     cells in peritoneal fluid with the debulking efficacy and CA 125 levels. Secondary to this~     the investigators intend to determine the pharmacokinetics of cisplatin and paclitaxel when~     administered in the IP cavity in the central circulation (plasma) as well as in the~     peritoneal fluid. In this observational explorative study women, aged younger than 70 years,~     who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in~     an adequate physical and biochemical state to receive chemotherapy are included.~     Immunological cell counts, tumor marker, immunological cell pathway activation and plasma~     concentrations of cisplatinum and paclitaxel in venous blood and in fluid aspirated from the~     abdominal cavity will be measured.~   "
14929|NCT02861859|"~     The purpose of this study is to evaluate whether adding olanzapine 5mg to standard~     antiemetic medication can significantly reduce chemotherapy-induced nausea and vomiting in~     breast cancer patients receiving emetogenic chemotherapy regimens such as anthracycline with~     cyclophosphamide-based chemotherapy and platinum-based chemotherapy.~      To help clinicians prescribe antiemetic medications in a more patient-centered,~     evidence-based and cost-effective manner, we've developed the world's first validated~     risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of~     this, it is now possible to perform a trial of personalized precision antiemetic therapy for~     breast cancer patients.~      Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains~     among the most feared and expected side effects of chemotherapy for breast cancer.~     Inadequately controlled CINV can significantly reduce a patient's quality of life, impair~     functional activity, lead to chemotherapy dose delays and reductions, and even~     discontinuation of treatment. The merit of current antiemetic medications is based on their~     ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is~     the major issue for breast cancer patients.~      With olanzapine demonstrating significant promise in preventing acute and delayed nausea,~     the investigators are proposing to evaluate guideline-recommended aprepitant-based triple~     regimen compared to the same regimen plus olanzapine (5 mg) for patients at high personal~     risk for CINV. For patients at low personal risk for CINV the investigators will also~     evaluate guideline-recommended double antiemetic regimen compared to the same regimen plus~     olanzapine (5 mg).~   "
14930|NCT02861846|"~     Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases~     with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to~     55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular~     disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including~     an Alzheimer's disease (AD), is also common. However, investigators do not have any marker~     that might help to identify the patients who develop epilepsy after 60 years and who might~     be, despite a normal cognitive functioning, already engaged in the pathophysiological~     process of AD.~      A number of data suggest a link between the pathophysiological process of AD and~     epileptogenesis:~      (i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is~     an aggravating factor for cognition, (iii) in animal models of AD, the relationship between~     neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a~     pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in~     these models, the administration of an antiepileptic drug protects from deterioration of~     cognition, (v) the close relationship between amyloid and neuronal hyperexcitability might~     be mediated by the inflammatory processes associated with AD, and particularly the~     microglial activation which role in epileptogenesis has been shown elsewhere.~      Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60~     years, the occurrence of epilepsy might reflect the presence of an ongoing amyloid~     pathology. Our goal is to identify through biomarkers of AD in the cerebrospinal fluid of~     patients who develop an epilepsy after 60 years with normal MRI and normal cognition those~     at high risk of later developing clinically defined AD.~      Identifying patients with amyloid pathology which would be expressed through epilepsy before~     the onset of cognitive dysfunction might help to adapt both the management of seizures and~     of the cognitive dysfunction.~   "
14931|NCT02861833|"~     This is a first care research focuses on the study of adaptation strategies implemented by~     cancerous wound patients. Today, advances in treatment generally increases the life~     expectancy of a patient with cancer. the patients thus live longer with their wound. How to~     live then? The literature review shows that there is research on adaptation strategies in~     cancer pathology and that different factors seem to interact with these strategies. However~     the investigators have not found written on the theme cancerous wound and adaptation~     strategies.~      the investigators conducted a pilot study of this research in medical oncology, Prof.~     service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation~     centers contacted but also areas for improvement. Indeed, the investigators now were doing a~     study of adaptation strategies implemented by the patient time T of his life. However,~     adaptation is a process in constant motion, the investigators want to identify two different~     time patients coping strategies following a specific charge nurse taking.~   "
14932|NCT02861820|"~     The study purpose is to examine whether there are structural or functional differences in~     the brains of individuals who use cocaine or amphetamines as opposed to control participants~     who have never used cocaine or amphetamines. More specifically, it will allow the~     investigator to see how the brain changes once people get sober and how those changes relate~     to successful recovery. This study will allow the investigator to examine the interaction~     between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than~     thought). Results from this study will inform new biologically-based interventions to~     compliment existing treatment programs, in the hope of leading the field in a new direction.~   "
14933|NCT02861807|"~     Alcohol use disorder (AUD) impacts millions of Americans and is associated with significant~     behavioral, social, economic, medical, and neurobiological dysfunction, yet current~     behavioral treatments for AUD are only modestly effective. The proposed research will test~     the efficacy of a novel behavioral intervention, which combines brain stimulation with~     mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and~     ultimately lead to large effect size reductions in heavy drinking among individuals with~     AUD. Given that mindfulness and brain stimulation are already available for home use there~     is great potential for the ultimate dissemination of the intervention on a large scale,~     which could have a significant impact on public health.~   "
14934|NCT02861794|"~     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.~     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant~     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of~     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have~     been developed to solve the problem. However, most of their designs are based on~     experimental data and little has been studied about their actual performance in vivo. In~     this study, the investigators will analyze the in vivo stability of the Global Medacta Knee~     Sphere (GMK Sphere) implant. Migration of the implants will be monitored with a high~     precision measuring method called Radiostereometric Analysis (RSA). The investigators assume~     the investigators study will contribute the development of more satisfying knee implants.~   "
14935|NCT02861781|"~     This project aims at identifying new determinants of type 2 diabetes in severe obesity. To~     do so, a biological collection, including tissues of interest in the field of metabolism,~     will be collected during bariatric surgery in obese patients. Three different groups of~     metabolic status of patients, corresponding to different stages of evolution of the disease,~     will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity.~      The main objective is to compare, between these 3 groups of patients, several biological~     processes that may be involved in the pathophysiology of type 2 diabetes and disorders~     associated with obesity, including:~        -  Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma,~          serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)~        -  Identification of metabolic signatures, protein and miRNA in plasma~        -  Immunoinflammatory response in adipose tissue~        -  Polymorphisms SNP from whole blood~        -  Histological analysis of tissue sections This main objective will be studied on samples~          taken at the time of surgery Secondary objectives will be to study the changes in~          metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of~          surgery, according to the initial metabolic state.~   "
14936|NCT02861768|"~     The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for~     suspected tuberculosis.~      Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis~     pharyngeal.~      Secondary~        1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus~          noninvasive pharyngeal samples taken routinely.~        2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the~          sample versus noninvasive pharyngeal samples taken routinely.~        3. Beijing genotype prevalence among patients with pulmonary tuberculosis.~   "
15042|NCT02860390|"~     This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old~     individuals with persistent asthma comparing differing levels of texting interventions with~     each other and with a usual care group. The two texting interventions include 1) texting~     only the individual with asthma and 2) texting the individual with asthma and an important~     person in that individual's life such as a parent or spouse. These two texting groups will~     be compared to a group receiving usual asthma care at Denver Health.~   "
14937|NCT02861755|"~     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans~     with depression receive adequate treatment, and one-third of those receiving treatment do~     not benefit. In this pilot project investigators will bring together two approaches that~     have the promise to reach large numbers of depression sufferers: a skills-based intervention~     for increasing positive affect and experiences in depressed individuals, delivered in an~     inexpensive self-paced mobile format. The study will make use of smartphone technology to~     improve conventional outcome measurement via in-the-moment emotion sampling and mobile~     assessment of heart rate variability, a predictor of cardiac health that may mediate some of~     the health effects of depression. The aims are: 1) Retool the existing web-based positive~     emotion intervention for use on smartphones, with innovative exercises that help~     participants bring the skills they are learning into real-life situations; 2) Perform a~     small feasibility trial of the mobile intervention on individuals with clinical depression~     recruited online 3) Eventually incorporate feedback from the small feasibility trial to~     improve the online intervention and conduct a full randomized trial on a larger scale~   "
14938|NCT02861742|"~     The KALICOU 3 study will evaluate the effect of emotional skills of patients and their~     partners on their individual disease subjective experience during care pathways, from~     chemotherapy to surveillance.~   "
14939|NCT02861729|"~     The purpose of this randomized controlled clinical trial is to evaluate the clinical~     outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium~     silicate ceramic system compared to partial coverage restorations fabricated with lithium~     disilicate ceramic system.~   "
14940|NCT02861716|"~     In this study the investigators aim to determine the analgesic effect and side effects of~     intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric~     patients undergoing major abdominal cancer surgeries.~   "
14941|NCT02861703|"~     Obesity presents serious psychological and physical consequences for breast cancer~     survivors, including diminished quality of life, poorer prognosis and increased mortality.~     As such, there is a great need to develop strategies for these women to maintain optimal~     body weight. Diet and exercise have been shown to lead to successful weight loss among this~     population but these effects are seldom sustained, plausibly because these efforts alone~     overlook less obvious, but equally important, psychosocial factors that can interfere with~     prolonged progress. This study will implement a group-based intervention addressing diet and~     exercise along with other psychosocial issues related to survivorship such as depression,~     fatigue, body image and social support. Based on the growing popularity and benefits of~     computer-based health care, including convenience and anonymity, this intervention will also~     be offered online, representing the first of its kind. It is hypothesized that 1) women in~     both intervention groups will achieve significantly greater loss in weight and improvement~     in psychosocial well-being than those in a control group and 2) women in the online group~     will achieve outcomes comparable to those in the face-to-face group. This research has the~     ability to improve the long-term health of breast cancer survivors by incorporating~     psychosocial interventions into standard medical care practices and has the potential to~     increase accessibility of these services using online technology.~   "
14942|NCT02861690|"~     The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal~     Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal~     Carcinoma~   "
14943|NCT02861677|"~     Background: Pharmacists have been proven to improve patient outcomes, medication adherence,~     glycemic control, reduce blood pressure, low-density lipoprotein, health care costs and~     length of hospital stay, and enhance quality of life.~      Objective: to measure the impact of clinical pharmacy service on patient care and cost~     saving of patients at inpatient wards and ambulatory care clinics of Jimma University~     Specialized Hospital.~      Methods: single center Randomized Controlled Trial will be conducted. Participants will be~     assigned to either pharmacy professionals' intervention group or non-intervention (control)~     group based on computer generated random number. The study will be done from July 26 to~     September 15, 2016. The total sample size is calculated with Open Epi online sample size~     calculator with 95% CI and 80% power. The total sample size is found to be 146 for~     inpatients and 473 for outpatients. Linear regression, student's t-test, logistic regression~     and chi-square test will be used for statistical analysis. Variables with p<0.05 will be~     considered statistically significant.~   "
14944|NCT02861664|"~     This study will evaluate the effectiveness of an experimental dentifrice containing stannous~     fluoride, an established dentine tubule occlusion technology, at reducing dentine~     hypersensitivity (DH) compared to a negative control dentifrice. The test and control~     dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative~     air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.~   "
14945|NCT02861651|"~     Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid~     leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The~     World Health Organization classification recognizes two subclasses, M6a, a leukemia with~     myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to~     distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic~     proliferation, which is increased when dysplasia is present. No recurrent cytogenetic~     abnormality is specific of AEL and the prognosis is poor with a median survival of 17~     months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in~     AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD~     and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database.~     To further characterize AEL, determine whether it constitutes a distinct class of AML and~     document the reasons for its poor prognosis, the investigators will search for molecular~     alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and~     next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid~     malignancies or in erythrocyte differentiation.~   "
15043|NCT02860377|"~     Mother spend a large amount of time with their children. It is assumed that mother~     contributes to their neurological development not only with visual stimuli, but also with~     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in~     response to the self-name being spoken by the mother than by a stranger. Therefore,~     investigators suppose that recorded maternal voice can stimulate the pediatric patients and~     thereby fasten the emergence from general anesthesia.~   "
14946|NCT02861638|"~     Postoperative rehabilitation is required for a successful outcome following total hip~     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to~     strengthen quadriceps, to restore normal gait, and to recover independence in activities of~     daily living. In the last decade action observation treatment, in addition to conventional~     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is~     growing evidence of the applicability of action observation training in rehabilitative~     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of~     cerebral palsy and of aphasia.~      Nevertheless those are small studies and one of them included a mixed population of hip and~     knee arthroplasty.~   "
14947|NCT02861625|"~     The aim of this randomized multicenter study is to evaluate the impact in offering the~     condolence letter to the family caregivers (indicated as the reliable person by the patient~     himself at each hospitalization) and a bereavement consultation with the reference~     physician.~   "
14948|NCT02861612|"~     This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in~     patients with cervical spinal injuries.~   "
14949|NCT02861599|"~     Before proposing this observational study protocol, a randomized study was attempted. This~     consisted in proposing to families of children with difficulties in learning to read, via~     the speech therapists who were treating them, to take part in a randomized trial that~     compared speech therapy alone with a combination of speech therapy and proprioceptive~     therapy. If parents agreed in principle with the study, the child underwent a complementary~     speech therapy examination and was referred to the nearest investigating doctor for~     inclusion. However, this study had to be abandoned because of insufficient recruitment (2~     patients included in 1 year). Despite the motivation and training of participating speech~     therapists, proposing a study based on randomization to families often in distress proved to~     be extremely difficult, as their conviction of the interest of proprioceptive therapy was~     greater than the available scientific evidence suggested. Direct recruitment by~     investigating ophthalmologists was not possible because they were consulted directly by the~     families so as to obtain proprioceptive therapy. The principle of randomization would thus~     not have been accepted.~      In light of the above, we decided to turn towards a non-randomized study comparing outcomes~     in two groups of children:~        -  children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte~          d'Or~        -  children managed by one of the four speech therapists who do not propose proprioceptive~          therapy and who accepted the principle of the study.~   "
14950|NCT02861586|"~     The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine~     against Chikungunya virus after one or two vaccinations by comparison of two different dose~     levels.~   "
14951|NCT02861573|"~     The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)~     combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC).~     There will be three cohorts in this study with 70 participants enrolled in each cohort:~     Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab +~     docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome~     measures will be assessed individually for each cohort.~   "
14952|NCT02861560|"~     A prospective case series investigating the efficacy and safety of dehydrated human~     amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure~     ulcers~   "
14953|NCT02861547|"~     Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The~     Glasgow score alone, assessed at the initial phase, is not enough to determine the~     prognosis.~      The aim of this study is to define and to evaluate a prognostic score for early death based~     on clinical and CT-scan findings in an observational retrospective derivation cohort of~     patients hospitalized for traumatic brain injury.~      This cohort will allow us to carry out a uni- and then multi-variate analysis so as to~     create a prognostic score for early death.~      We will subsequently test this score in a prospective validation cohort.~   "
14954|NCT02861534|"~     This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event~     driven study of vericiguat (MK-1242) in participants with HFrEF. The primary hypothesis is~     vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of~     the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in~     participants with HFrEF.~   "
14955|NCT02861521|"~     Moving one's joints through their full range of motion (ROM) is crucial for health and~     wellbeing. Those who are unable to do so have difficulty carrying out simple activities like~     walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA)~     is the most common form of arthritis. About a third of people with knee OA develop knee~     flexion contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC~     before a knee replacement is a big risk factor for redeveloping one after the operation.~     Many people with a KFlC in the knee for surgery also have a KFlC in the other knee. The~     investigators believe that this non-surgical KFlC increases the risk of re-developing a KFlC~     in the surgical knee after surgery by encouraging bending of the surgical knee to avoid one~     leg being shorter than the other. No one has ever looked at whether fixing this leg length~     difference using a shoe lift would prevent this problem and there is little information to~     help design such a study. Here the investigators will see if testing shoe lift use for~     preventing KFlC is feasible. The investigators hypothesis is that a study evaluating the~     benefit of using a shoe lift to correct leg length difference in the non-surgical knee is~     feasible.~   "
14956|NCT02861508|"~     The purpose of the proposed research is to examine whether incorporating point-of-care~     ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect~     diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared~     to usual care.~   "
14969|NCT02861339|"~     A retrospective study has shown the association between the inflammatory bowel diseases~     (IBD) and the presence of a keratoconus. This new study will measure the prevalence of~     keratoconus and follow its activity in patients affected by IBD and followed up in~     hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will~     be compared to known data of literature about general population.~      The secondary purpose is to search for a relationship between the presence of a keratoconus~     and activity criteria of IBD.~      Perspectives are a systematic screening for keratoconus in patients affected by IBD with the~     amelioration of the ophthalmologic care of IBD patients and confirmation of the recent~     hypothesis of inflammatory origin of keratoconus.~   "
14957|NCT02861495|"~     The proposed study of humeral shaft fractures in adults will examine outcomes in patients~     treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures~     (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an~     internal gear system controlled wirelessly by rare earth magnets, which typically offers~     distraction for lengthening. In the humerus however, during the treatment of acute~     fractures, this percutaneously inserted nail can also offer compression during the healing~     process, thereby negating the effect of gravity, which may in turn lead to a faster and more~     consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of~     the nail may employ an accordion technique (alternating compression-distraction, a feature~     unique to this implant.~   "
14958|NCT02861482|"~     Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major~     causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic~     medical disorders (including inherited and acquired coagulopathy). Management of PPH~     contains the application of uterotonic agents, using hemostasis agents, transfusion of blood~     component products, conservative procedures (intrauterine packing or balloon tamponade,~     compression sutures, vascular ligation and uterine artery embolization using sponges), and~     even hysterectomy.~      The Bakri Balloon has attained its efficacy and popularity ever since it was invented by~     Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for~     PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical~     data of preventive usage.~      The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early~     management of PPH.~   "
14959|NCT02861469|"~     This qualitative study aimed to describe and understand the factors leading to the admission~     in emergency unit of patients coming from their home, in an end of life situation.~      This study was conducted in the university hospital of Besançon, France. Semi-structured~     interviews were conducted with general practitioners and family members in order to~     understand the factors leading, from their points of view, to the admission in emergency~     unit whereas this hospitalization wasn't necessary.~   "
14960|NCT02861456|"~     The goal of the proposed research is to test the feasibility of a functional progression~     program to reduce cost and possible radiation exposure for adolescent athletes with low back~     pain. Specifically the investigators plan to test the feasibility of using progression in~     rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with~     low back pain, instead of using advanced imaging which is the current practice. The~     investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging)~     and 10 of proposed intervention (functional progression) to assess the feasibility of using~     functional progress to guide treatment. The outcomes measured will be number of days for~     rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability~     to return to sport, time needed to return to sport. If this pilot demonstrates the~     feasibility and a decreased rate of advanced imaging and similar clinical outcomes the~     investigators plan to progress this work into larger trials.~   "
14961|NCT02861443|"~     The main objective of this study was to determine the frequency of the practice of colonic~     irrigation (CI) among patients with a colostomy,.~      Other objectives are:~        -  To compare the quality of life between a group of patients with a colostomy and~          practicing CI versus a group of patients with a colostomy without CI.~        -  To determine the causes of non-realization of the CI or failure.~        -  To determine the conditions of realization of colonic irrigation by the return of user~          experience (time of day when the CI is practiced, amount and type of fluid used, time~          spent in the bathroom, time to recurrence of stool, media used between two~          irrigations).~   "
14962|NCT02861430|"~     Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular~     biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy~     for non metastatic colon cancer.~   "
14963|NCT02861417|"~     The goal of this clinical research study is to learn if busulfan with cyclophosphamide (when~     given with other helper drugs listed below) can help control the diseases listed above when~     given before a stem cell transplant. The safety of these study drug combinations will also~     be studied.~   "
14964|NCT02861404|"~     The principal objective of the study is the evaluation of the role of Human Papilloma Virus~     (HPV) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or~     not. This epidemiological study is an ancillary study of the prospective, randomized~     controlled, clinical study VRAIE (sponsor: APHP) comparing 5 usual strategies in the~     management of plantar warts.~   "
14965|NCT02861391|"~     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in~     patients with urinary stress incontinence (USI). Eligible subjects will receive 3 treatment~     sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last~     treatment.~   "
14966|NCT02861378|"~     Dental procedures often require the use of local anesthesia. The effects of the anesthesia~     usually linger for some time after the dental procedure is completed which can lead to~     discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown~     phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal~     of local anesthesia compared to sham injections. However, no trials have been conducted~     comparing phentolamine mesylate to a true control injection. Such trials are needed in order~     to definitively show that it is the phentolamine mesylate itself that is causing the~     reduction in anesthesia rather than a dilution effect.~      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial~     evaluating the difference in time required to the return of normal soft-tissue sensation and~     function in participants who had received an inferior alveolar nerve block (using 2%~     Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse~     (phentolamine mesylate) or 2) sterile physiological water (control).~      The study population will comprise dentistry and dental hygiene students of the second year~     classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen~     because these students usually practice dental anesthesia on each other as a part of a~     course on local anesthesia.~      This proposed pilot scale study will be a double-blind controlled trial using parallel~     groups. As part of their usual anaesthesia course, the dental and dental hygiene students~     will be practicing their inferior alveolar nerve injections on one another using 2%~     Lidocaine 1:100,000 epinephrine. Students who decide to participate in the study will be~     randomly assigned to one of two groups: Group 1 will receive an injection of OraVerse~     (treatment group), while Group 2 will receive an injection of sterile physiological water~     (control group). The time required to the return of soft-tissue sensation and function will~     be assessed using a questionnaire.~   "
14967|NCT02861365|"~     This is a study of the perfusion of the myocardium in adults with specific forms of repaired~     congenital heart disease using established cardiac MRI techniques and correlating perfusion~     with clinical outcomes.~   "
14968|NCT02861352|"~     The purpose of this study is to determine the effect of a moderate decrease in dietary zinc~     on DNA strand breaks and other cellular zinc biomarkers.~   "
14970|NCT02861326|"~     Aim: The aim of this study was to evaluate the relationship between initial probing depth~     (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT)~     in chronic periodontitis patients.~      Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic~     periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling~     and root planing was applied in two sessions. Probing depth (PD), clinical attachment level,~     gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites~     were grouped according to their IPD and root number of teeth as single- or multi-rooted.~   "
14971|NCT02861313|"~     Comparing the quality of life and periimplant condition around a single implant retained~     mandibular overdenture in two groups one will have a ball attachment and the other is having~     a (CM-LOC) one.~   "
14972|NCT02861300|"~     This study has two portions. The main goal of the Phase I portion of this research study is~     to see what doses of CB-839 and capecitabine can safely be given to patients without having~     too many side effects. Other purposes of this research study will be to determine what side~     effects are seen with this combination of medicines. The Phase II portion of the study will~     test how many patients show shrinkage in their tumor with this combination of medicines and~     what changes occur inside the cancer cells and blood cells after treatment.~   "
14973|NCT02861287|"~     This study aims to realize an economic evaluation of the introduction of Plerixafor in~     addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed~     or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF~     alone.~   "
14974|NCT02861274|"~     OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio~     inhibitory response to the head up tilt testing (HUT) evaluation.~      METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without~     asystolia (2A type) have been enrolled in this study. These patients have been studied by~     electrophysiological study (ES). After ES patients have been differently treated~     (interventional treatment group A, v/s drug therapy group), and followed up during 360 days,~     to evaluate syncope recurrences.~   "
14975|NCT02861261|"~     The purpose of this study is to conduct a multicenter randomized, double-blind,~     placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after~     berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes~   "
14976|NCT02861248|"~     A prospective study to evaluate the efficacy and safety of FMRT for treating~     non-hypertrophic post-burn scars in an Asian population.~   "
14977|NCT02861235|"~     Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the~     presence and severity of abnormalities of myocardial perfusion, as well as the extension of~     infarction residua. However, actual imagery devices (gamma cameras) have low resolution and~     detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection~     sensitivity and could allow proportionally diminishing injected activities or recording~     times. Only one pilot study has been recently published on this type of camera, the D.SPECT~     camera.~      This study will compare images recorded during 15 to 20 minutes by conventional cameras and~     2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions.~     The purpose is to demonstrate the equivalence of images recorded by two camera types for~     diagnostic information and the secondary purpose is to demonstrate the superiority of the~     D.SPECT camera in terms of image quality.~   "
14978|NCT02861222|"~     The purpose of this study is to determine the toxicity and tolerance of Myocet® in children~     and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20%~     of the dose recommended for adults and a dose recommended for adults, administered in single~     dose in 1-hour perfusion each 21 days.~      Other purposes are to determine the recommended dose of Myocet and to assess the response to~     drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite~     doxorubicinol during 72 hours after Myocet administration will also be studied.~   "
14979|NCT02861209|"~     This study aims to develop, implement and evaluate a care pathway for patients with cancer~     who are treated with oral anticancer drugs (OACD).~      The care pathway will be developed in six hospitals in Flanders, and will be adapted to the~     local setting and situation.~      The investigators hypothesize that the implementation of a care pathway will increase the~     quality of the drug therapy, the communication between health care professionals (HCPs) and~     patients, and will lead to an improved level of self-management and adherence. Moreover, the~     invesitgators hypothesize that the care pathway will facilitate the communication between~     HCPs in the hospital setting and in ambulatory care, and will improve counseling skills,~     self-efficacy and self-confidence of HCPs.~      At the end of the study, a roadmap for the nation-wide implementation of a similar care~     pathway will be constructed based on the experiences of the participating hospitals. This~     roadmap will certainly include an e-learning platform for healthcare professionals.~   "
14980|NCT02861196|"~     This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular~     invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment~     model，then to clarify the probability of bladder preservation, corresponding cancer specific~     survival, and the quality of life.~   "
14981|NCT02861183|"~     A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to~     provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).~   "
14982|NCT02861170|"~     This study evaluates the effectiveness of a brief mindfulness-based intervention on~     post-operative pain and disability among anxious patients with chronic pain undergoing total~     hip arthroplasty.~      All participants will receive an educational brochure and links to videos containing~     strategies for coping with pain and anxiety. The half of the participants who are allocated~     to the treatment arm will also receive a 10 minute mindfulness intervention called a body~     scan.~   "
15007|NCT02860845|"~     The purpose of this study is to determine whether a formula of boric acid and probiotics for~     vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis~     in comparison to pharmacological reference controls (depending on the suspected diagnosis).~   "
15054|NCT02860234|"~     This study is designed to test the efficacy of tailored operative or non-operative~     management (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity~     modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main~     purpose of this study is to increase organ-preservation rate for low-risk rectal cancer~     patients.~   "
14983|NCT02861157|"~     The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based~     technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes~     disease- and treatment-related knowledge through interactive and game-based educational~     materials; (b) support adherence to the treatment regimen through customized task prompts~     via mobile and web-based delivery; and (c) promote patient-provider communication through~     real-world data collection and feedback loops. Investigators will examine the effectiveness~     of the Planet T1D mobile app and website in improving treatment adherence, disease-related~     knowledge, transition readiness, condition management, and the psychological correlates of~     these variables in youth with type 1 diabetes.~   "
14984|NCT02861144|"~     The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities is a randomized~     control trial that will test the effectiveness of partnership incentives plus evidence-based~     education to optimize glycemic outcomes among diabetic patients compared with usual care.~   "
14985|NCT02861131|"~     Substantial respiratory morbidity has been associated with postoperative residual paralysis,~     which is fairly common after general anesthesia involving a neuromuscular blocking agent.~     Common practice in United States is to reverse neuromuscular blockade with neostigmine at~     the end of surgery. A new drug with evidence of more complete neuromuscular reversal has~     been developed, sugammadex. The objective of this study is to determine if a strategy of~     rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects~     with any postoperative pulmonary complication, compared to neostigmine.~   "
14986|NCT02861118|"~     The purpose of this study is to evaluate the impact of the co-morbidities profile on~     treatment response in inflammatory bowel disease (IBD) patients.~   "
14987|NCT02861105|"~     The purpose of this study is to assess the efficacy of LMWH treatment in women with~     unexplained infertility and negative immunological markers undergoing ICSI.~   "
14988|NCT02861092|"~     It exists recommendations to get an optimal antibiotic treatment for bone and joint~     infection and prescription of antibiotics in the bone and joint infections on material meets~     certain obligations: the micro-organism must be known, the antibiotic therapy must be~     started in association, obtaining high plasma levels, use of molecules having good bone~     circulation. It is recommended to initially administer treatment with intravenous route and~     to propose an oral relay, under conditions. It is recommended to administer the antibiotic~     treatment for at least 6 weeks.~      The dosages of antibiotics are adapted to the weight of patients in order to respond to~     those recommendations. But little is known about the optimal dose of treatment to give to~     obese patients (BMI>=30) and the frequency of serious adverse events in these patients in~     which the dosage is then higher can be more important compared to non-obese patients. The~     aim of the study is then to evaluate the risk of occurrence of serious adverse events in~     obese patients and to identify risks factors.~      This study consists in a retrospective cohort of obese patients treated for a bone or joint~     infection and having had a serious adverse event. Several data are collected concerning:~     demographics data, treatment responsible of the serious adverse event (molecules, dosage,~     route), description of the serious adverse event, residual rate for vancomycin.~   "
14989|NCT02861079|"~     This study evaluates the addition of transcervical Foley catheter balloon and vaginal~     prostaglandin E2 in induction of labor at term. Half of participants will be used combine~     transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will~     be used alone vaginal prostaglandin E2.~   "
14990|NCT02861066|"~     Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,~     patients often face barriers to accessing mental health care, particularly psychotherapeutic~     interventions, including long wait-times and demanding therapeutic protocols. For instance,~     Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of~     depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over~     30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to~     care. The goal of this project is to test the effectiveness of an Abbreviated MBT (<10 hours~     of clinical time and <10 hours of homework) in reducing symptoms of depression/anxiety and~     improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing~     mental health care.~   "
14991|NCT02861053|"~     The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet~     inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The~     beneficial role of a regular physical activity on the quality of life of patients having an~     IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The~     mechanism by which the physical activity could improve the quality of life of the patients~     remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014].~     Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated~     the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It~     was recently demonstrated that the chronic fatigue observed in patients with IBD came along~     with a physical reduction in the performances during the exercise test and a reduction in~     the physical activity of the patients [Vogelaar, 2015].~      Our hypothesis is that a regular moderate physical activity could improve physical~     performance during an effort et could reduce the chronic fatigue and improve their quality~     of life.~   "
14992|NCT02861040|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug volasertib is in combination with liposomal vincristine (Marqibo;~     an FDA-approved drug) in patients with relapsed/refractory acute lymphoblastic leukemia.~     While VSLI demonstrated an overall response rate of 35% in Acute Lymphoblastic Leukemia~     (ALL) patients that had failed to respond to or relapsed after chemotherapy, combining it~     with other agents may increase clinical benefit.~      Volasertib inhibits proteins involved in the cell cycle that are increased in ALL. When~     volasertib inhibits these proteins ALL cells die. In the laboratory, volasertib has been~     shown to increase activity of vincristine against ALL cells. Therefore, we think the~     combination of volasertib and VSLI will be more effective against your leukemia than either~     drug used alone. This study will try to find out what effects, good and/or bad, this drug~     combination has on the patient and their cancer, and to find a dose that may be used in~     future studies.~   "
15055|NCT02860221|"~     The purpose of this study is to compare the blood loss of intravenous and topical~     administration of low dose epinephrine plus combined administration of intravenous and~     topical tranexamic acid for primary total knee arthroplasty.~   "
14993|NCT02861027|"~     Due to the importance of the functions of the gluteus medium, mainly during gait, it becomes~     essential to strengthening early in the musculature. The association of muscle strengthening~     with the Functional Electric Stimulation (FES) comes to accelerate stabilization of hip,~     leading to functional rehabilitation early and improves the quality of life through~     rehabilitation in social life and activities of daily life. Thus, it becomes a relevant~     study to assess objectively the implications of FES in muscle strengthening of gluteus~     medium associated with the Physiotherapy Protocol Total Hip Arthroplasty (PPTHA), through~     the assessment of motor performance in patients undergoing surgery for Total Hip~     Arthroplasty (THA), aiming to better rehabilitation strategies for this population.~      The objective of the research is to assess the effects of functional rehabilitation through~     PPTHA associated with FES in the gluteus medium compared only with the PPTHA, in patients~     undergoing surgery for THA.~      The principal hypothesis is that there is difference between the functional rehabilitation~     of the patients undergoing PPTHA associated with the FES of gluteus medium, after THA and~     the patients submitted only to PPTHA.~   "
14994|NCT02861014|"~     The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to~     assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting~     Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a~     Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4~     weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),~     and a Follow-up period of at least 2 years.~   "
14995|NCT02861001|"~     Optical guidance for percutaneous tracheotomy in intensive care is usually performed by~     bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL)~     has been introduced that allows for endotracheal visualization.~      For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy~     with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory~     results, patients are randomized to receive optical guidance by bronchoscopy or by~     VivaSight-SL tube. The primary end point is the visualization through the tube camera of~     endotracheal landmark structures for tracheotomy and visualization of the needle insertion~     (according to score, see detailed description).~   "
14996|NCT02860988|"~     The purpose of this study is to determine differences among incarcerated or recently~     incarcerated fathers who receive targeted services and those who do not.~   "
14997|NCT02860975|"~     The purpose of this study is to define the safety and the biochemical-physiological response~     of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.~   "
14998|NCT02860962|"~     A proof-of-concept study to determine the antidepressant potential of Dextromethorphan for~     treating depression associated with Major Depressive Disorder in inpatients.~   "
14999|NCT02860949|"~     Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients~     undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular~     infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited~     on the added benefits of PCI using different combinations of local anesthetic agents.~     Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and~     without PCI.~      Half of participants received LAI with PCI, while the other half received LAI without PCI~     during total knee arthroplasty.~   "
15000|NCT02860936|"~     ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard~     treatment is surgical excision followed by radiotherapy in selected cases. The disease is~     characterized by a progressive course with local and distant recurrences. First-line~     treatment is palliative chemotherapy that had modest results. Expression of the epidermal~     growth factor receptor in ACC of salivary origin has been reported. Several papers report~     that a high percentage of ACCs carries a chromosome translocation that results in the~     overexpression of the oncogene MYB, which is involved in cell proliferation, apoptosis,~     differentiation and in upregulation of several growth and angiogenetic factors contributing~     to the autocrine activation of the FGFR and VEGFR-mediated angiogenesis. Recently two whole~     genome sequencing of several ACC tumor/normal pairs have found mutations in genes involved~     in the FGF/IGF/PI3K pathway corroborating the hypothesis that this subset might benefit from~     inhibitors of this pathway. Based on these premises several antiangiogenic drugs and FGFR~     inhibitors are currently under investigation and a response rate of 11% was observed in ACC.~     Lenvatinib is an oral multiple RTK inhibitor targeting VEGFR-1-3, FGFR-1-4, RET, c-KIT, and~     PDGFR. On February 13, 2015 the drug has been approved by FDA for the treatment of patients~     with locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid~     cancer. Based on preclinical and clinical data, the investigators believe that targeting~     angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to~     test Lenvatinib in patients with relapsed and/or metastatic ACC.~   "
15001|NCT02860923|"~     This hypothalamic obesity is associated with serious metabolic and psychosocial~     consequences.~      The purpose of the study is to compare the change of body weight after 6 months treatment~     with a lifestyle intervention + exenatide compare to the one after the same lifestyle~     intervention+ placebo in adults patients suffering from a hypothalamic obesity due to~     treatment of craniopharyngioma.~   "
15002|NCT02860910|"~     The general objective of this study is to advance insight into non-pharmacological~     treatments for maturing women that impact psychological health and wellbeing of women~     adapting to menopause, a natural but often challenging developmental milestone.~   "
15003|NCT02860897|"~     PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy~     by randomizing treatment modalities to determine differences in adherence to either form.~      HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen~     therapy when prescribed as a 6 week course of postoperative therapy after female pelvic~     reconstructive surgery.~   "
15004|NCT02860884|"~     The main objective of this study is to evaluate the ability of infrared spectroscopy to~     discriminate simple hepatic steatosis from NASH~   "
15005|NCT02860871|"~     The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave~     Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients~     from other causes of joint effusion by analyzing ex vivo joint fluid samples collected~     during routine clinical care.~   "
15006|NCT02860858|"~     Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity~     in patients with symptomatic macular PCV.~   "
15008|NCT02860832|"~     Background and significance: Though the problem of bullying among adolescents is evidently~     increasing and of a serious social concern, it is often undetected until serious outcomes~     have surfaced. In recent years, along with the rapid expansion of the Internet, social~     network services (SNS) and smart phones, cyber-bullying has been growing. Compared to the~     traditional bullying, cyberbullying is unique in nature and potentially more hazardous in~     terms of invisibility, lack of control, where it enables communication with a broad range of~     people at any time and place.~      To explore deeper understanding of the magnitude and the impact of the bullying among~     adolescents in Taiwan to inform public policy and future health intervention programs may be~     beneficial not only to Taiwan but also to Asia as a whole. Many Asian countries now suffer~     the similar problems of bullying among adolescents, since these countries share similar~     characteristics of development (spread of internet, SNSs and smart phones).~      Goal and objectives: This study aims to explore Taiwanese adolescents' experiences,~     perceptions, opinions and mental health regarding cyberbullying and traditional bullying to~     inform the development of questionnaire in the quantitative phase of mixed methods study.~      Study design: A qualitative study design with in depth interviews will be adopted.~      Target population and study setting: Senior high school students will be recruited from~     Taipei city, Taiwan.~      Sample size and sampling method: Participants will be sampled by convenience sampling until~     thematic saturation is attained, probably around 50 students.~      Data collection: Face-to-face in-depth interview with semi-structured questionnaire will be~     used.~      Data analysis: All interviews will be voice-recorded, transcribed, analyzed by thematic~     analysis procedure. Analysis process will include familiarization, coding, searching for~     themes, reviewing the themes, defining, naming themes and writing up or weaving the analytic~     narrative. Triangulation and supervision will also ensure credibility and balance in the~     process.~   "
15009|NCT02860819|"~     This is a proof-of-concept study to define efficacy of gemcitabine, carboplatin and~     VELIPARIB (ABT-888) in patients with refractory germ cell tumors (GCTs). PARP proteins are~     involved in base excision repair (BER), one of the major DNA repair system in cells and PARP~     is overexpressed in testicular GCTs (TGCTs) compared to normal testis and data suggest that~     PARP overexpression is early event in TGCTs development. Patients with low PARP expression~     in primary tumour had non-significantly better OS compared to patients with high PARP~     expression (5-year OS 89.2% vs 78.7%; HR=0.50, 95% CI 0.21 to 1.17, p=0.12). The aim of this~     study is to evaluate PARP inhibitor VELIPARIB in combination with gemcitabine, carboplatin~     in patients with refractory germ cell tumors (GCTs).~   "
15010|NCT02860806|"~     The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single~     escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to~     evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872~     administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of~     one selected dose administered as a continuous IV infusion at various durations and to~     characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous~     infusion.~   "
15011|NCT02860793|"~     The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned~     to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and~     CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia~     (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to~     convey promigratory and antiapoptotic signals into the cell and represents an independent~     prognosis factor of survival in patients treated with induction chemotherapy. This study~     aims at:~        -  evaluating the impact of PTK7 expression on primary AML cells ex vivo~        -  evaluating the diagnostic and prognostic value of a soluble form of PTK7~   "
15012|NCT02860780|"~     The main purpose of this study is to evaluate the safety of the study drug prexasertib in~     combination with ralimetinib in participants with advanced or metastatic cancer.~   "
15013|NCT02860767|"~     The purpose of the study is to evaluate the concentrations of antibiotics used as empirical~     treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee~     prostheses~   "
15014|NCT02860754|"~     This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI~     score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac~     surgery. In addition, this study will assess whether the patients' reported MET score~     corresponds to the determined MET score from the 6MWT distance completed.~   "
15015|NCT02860741|"~     Rural African Americans are disproportionately impacted by social stressors that place them~     at risk for experiencing elevated depressive symptoms. This project will test the~     effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use~     within rural African American churches. Further, this project will gather data on strategies~     necessary to promote the successful implementation of this intervention within rural African~     American churches.~   "
15016|NCT02860728|"~     Structural changes in skeletal muscles of patients with chronic obstructive pulmonary~     disease (COPD) have been linked to impaired muscle function, reduced exercise capacity, and~     increased mortality associated with this disease. Muscle dysfunction also contributes to~     dyspnea intensity and the ability to sustain exercise, making aerobic exercise training~     intolerable at the intensity and/or volume required to achieve clinically important changes.~     Resistance training (RT) is an attractive exercise modality because it is efficacious and~     more tolerable initially. No work has examined whether a short-term RT program can reduce~     exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients~     with COPD.~   "
15017|NCT02860715|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study~     designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7~     in healthy volunteers.~   "
15018|NCT02860702|"~     A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in~     infants with single ventricle physiology fed an exclusive human milk diet prior to, and~     throughout the post-operative period following, surgical repair. Human milk is defined as~     expressed human milk or donor milk and its derivatives, human milk-based fortifier and human~     milk caloric fortifier.~      The study hypothesis is that infants fed an exclusive human milk diet will have short and~     long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes~     while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).~   "
15019|NCT02860689|"~     Objective: To analyze the association between sexual function of men with spinal cord injury~     with possible predictive factors for dysfunction.~   "
15041|NCT02860403|"~     Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional~     rehabilitation and cerebral plasticity through the qualitative and quantitative mental~     practice approach. For this, the investigators will use magnetoencephalography (MEG) but~     also physiological and behavioral indicators developed by the Laboratoire de la Performance~     Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.~   "
15020|NCT02860676|"~     The purpose of the study is to investigate the safety of the investigational drug called~     cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug~     called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that~     is on the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and~     survival of the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should~     target the cancer cells. Cirmtuzumab is considered experimental because its use is not~     approved by United States (US) Food and Drug Administration (FDA).~      Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease~     the number of CLL cells, the investigators do not know if this will work in humans.~     Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerable in study~     participants when given for a duration of 6 to 12 months.~   "
15021|NCT02860663|"~     Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3~     (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is~     currently not scientifically established.~      Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2~     affected vitamin D status equally in humans and if rejected, to estimate the difference in~     activity.~      Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded~     randomized cross-over study with 12 young, apparently healthy male volunteers and was~     performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers~     received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6~     weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d~     VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in~     serum were quantified my LC-MS/MS using 0.1 mL serum.~   "
15022|NCT02860650|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.~   "
15023|NCT02860637|"~     In addition to the motor and sensory functions, sexual function changes after spinal cord~     injury and is considered one of the most common problems, ranging from a decrease in sexual~     desire to disturbances of erection, orgasm and ejaculation.~      Objective: To assess the impact of the complexity of traumatic spinal cord injury in male~     sexual function.~   "
15024|NCT02860624|"~     This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to~     that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of~     GERD.~   "
15025|NCT02860611|"~     Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s~     while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell~     auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via~     an association with T helper cells. In this study investigators aimed to investigate the~     difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.~      The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used~     oral antidiabetics but insulin before and 31 healthy subjects (CG).~      Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)~     levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were~     compared with those in T2DPs and controls.~   "
15026|NCT02860598|"~     Anemia concerns a lot of patients with cancer and affects their quality of life (QOL).~     Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating~     agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin~     level (Hb) and is a validated alternative to transfusion.~      However, in hematology, if there are some specific recommendations for the use of ESAs in~     lymphoid pathology, there are none for myeloid disorders and in the context of autografts~     and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are~     in particular interested in both indications: treatment of anemia in acute myeloid leukemia~     (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a~     non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell~     source.~   "
15027|NCT02860585|"~     The objective of this study was to evaluate the outcome of patients affected with different~     subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and~     autologous haematopoietic progenitor cell transplantation.~   "
15028|NCT02860572|"~     Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most~     common trigger to administer fluid bolus in a multinational practice survey in intensive~     care. The effect of fluid bolus on cardiovascular variables can be very short-lived among~     patients in shock suggesting that fluid boluses in the optimization phase are unlikely to~     improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor~     renal response to fluid bolus.~      Objective: To investigate, whether fluid bolus - as a standard of care - improves urine~     output in oliguric patients compared to a non-interventional follow-up approach without~     fluid bolus.~      Design: Investigator-initiated, open, randomized, controlled study~      Interventions:~        1. Intervention group - follow-up without intervention~        2. Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)~      Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and~     sepsis~      Trial size: 120 patients randomized in 4 ICUs~   "
15029|NCT02860559|"~     This is a study of stem cell transplantation with TBX-1400 in pediatric subjects with severe~     combined immunodeficiency (SCID).~      The donor cells are exposed to a protein that has been shown in the laboratory to improve~     the ability of the donor cells to make blood and immune cells after transplant. Exposure of~     the donor cells to this protein does not modify the genes in the cells in any way.~      This study has two goals. The first goal is to find out if transplant with TBX-1400 is safe.~     The second goal is to find out what effects TBX-1400 stem cells have on time to engraftment~     in pediatric subjects with SCID. The study hypothesis is that TBX-1400 cells will shorten~     the time to immune reconstitution after transplant.~   "
15030|NCT02860546|"~     A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Patients with~     Microsatellite Stable Refractory Metastatic Colorectal Cancer~   "
15056|NCT02860208|"~     The objective of this prospective clinical study was to evaluate the 3-year outcomes of~     anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant~     therapy (SPIT) programme was followed.~   "
15031|NCT02860533|"~     The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the~     photoplethysmography signal of the inbuilt camera can measure blood pressure (BP)~     fluctuations with sufficient correlation compared to the goldstandard oscillometric BP~     measurements. Investigators will recruit patients who are scheduled for a routine treadmill~     stress test and assess their blood pressure before and right after the test with the~     smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced~     BP fluctuations are encountered during vigorous activities. The primary endpoint of the~     iPARR DELTA BP Study is the correlation of the absolute difference of subsequent~     measurements between both techniques. If the relative chances of BP fluctuations are~     sufficiently assessed with this new device, BP fluctuations could be monitored continuously~     after calibration.~   "
15032|NCT02860520|"~     The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading~     to severe low vision and is the leading cause of consultation in reference centers dedicated~     to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity~     (clinical, genetic and molecular), which made them unreachable by traditional molecular~     diagnostic sequencing technology by the large number of genes to be tested (> 190).~      The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected~     possibilities of investigation and ultimately to improve the care of patients. This project~     aims to study the genetic and molecular epidemiology of an interregional french (grand EST)~     cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual~     field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190~     known genes (https://sph.uth.edu/retnet/).~      This research will provide a molecular epidemiological cohort study compared to prior~     publications on the frequency of genes involved. The benefit for patients is important to:~     establish a mode of transmission of the disease and optimize genetic counseling (currently~     very empirical); establish phenotype-genotype correlations in the French population (very~     few studies to date) and from the data of international literature; identify patients likely~     to be included in future therapeutic protocols of research; identify patients with~     significant potential for future projects to identify new genes.~      The primary purpose of the protocol is to use high throughput sequencing to identify~     pathogenic variants in genes involved in RP.~      The secondary purposes will be the following:~        -  Determining the diagnostic yield~        -  Study the genotype-phenotype correlation.~      The secondary purposes will be the following:~        -  Determining the diagnostic yield~        -  Study the genotype-phenotype correlation~   "
15033|NCT02860507|"~     The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing~     deep neuromuscular blockaded (induced by rocuronium)~   "
15034|NCT02860494|"~     Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the~     development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and~     skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients,~     are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a~     topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective~     is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy~     and safety of topical everolimus versus placebo in patients with angiofibromas.~   "
15035|NCT02860481|"~     FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the~     diagnosis of cancer.~      A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal~     melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will~     include n=10 patients per histological type except for breast cancer (n=50). 100 patients~     are expected in this cohort.~      A second cohort will explore the more promising histological type (if any) in term of~     incidence of detection. 100 patients are expected for this second cohort.~   "
15036|NCT02860468|"~     The compliance of participants in cranberry related clinical trial is poor due to the~     bitterness and astringency of cranberry products. There is a pressing need for an effective~     approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant~     Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models~     established from the investigator's previous study provide an opportunity to identify~     cranberry juice consumers. In this blinded, placebo-controlled, cross-over study,~     investigators hypothesize that the established statistical models of PLS-DA (Partial least~     squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant~     analysis) can identify cranberry juice consumers and non-consumers by analyzing the~     metabolomic changes in blood and urine among young women. In order to further explore the~     function of cranberry, microbiome profile will also be compared between cranberry juice~     consumption and placebo consumption after long-term treatment. Another comparison of~     metabolomic changes between short-term treatment and long-term treatment will be made to~     further identify candidate biomarkers of cranberry consumption and explore the correlation~     between acute effects and chronic effects of cranberry.~   "
15037|NCT02860455|"~     The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of~     blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard~     laboratory blood gas analysis (COHb) have reported contradictory results.~      the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO~     poisoning, enabling rapid detection and management of patients with suspected CO poisoning~     in the prehospital emergency setting This study assesses the diagnostic value of pulse~     CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital~     management of patients with suspected carbon monoxide (CO) poisoning.~   "
15038|NCT02860442|"~     The overall goal for the study is to test the efficacy of a smartphone app which includes an~     alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for~     National Guard members in the State of Ohio who meet criteria for at-risk drinking in the~     previous 3 months. The main hypothesis is that those in the SP-BI group with have reduced~     frequency and intensity of at-risk drinking and fewer binge drinking episodes.~   "
15039|NCT02860429|"~     The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on~     gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed~     gastrointestinal cancer based on pathology or cell biology.They are randomized into 2~     groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin~     20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven~     days in addition to the chemotherapy.The control group only receive the same chemotherapy~     with the treatment group.Both group have the same adjuvant therapy.Mainly to study of~     oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve~     toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug~     toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory~     cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.~   "
15040|NCT02860416|"~     The purpose of this study is to collect additional Investigational cognitive tasks and~     additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).~   "
15044|NCT02860364|"~     Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic~     surgeries to be performed safely. Hypothermic circulatory arrest provides protection to~     cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during~     surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these~     consequences, a trend towards warmer core body temperatures during circulatory arrest has~     emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C)~     hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the~     length of cardiopulmonary bypass time and other key measures of morbidity and mortality.~   "
15045|NCT02860351|"~     In the present study, the cross-sectional area of subclavian vein, the distances of~     subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different~     head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous~     breathing adults.~   "
15046|NCT02860338|"~     This retrospective study is a more extensive, confirmatory analysis of the cognitive and~     functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA~     and compares specialized dementia care and a comprehensive treatment approach versus usual~     care delivered in a non-specialist setting.~      The first group of patients (n= 328) was seen by a dementia specialist, who utilized a~     standardized assessment and treatment protocol (CNS). This included comprehensive~     identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing~     metabolic conditions as well as maximally- dosed FDA-approved medications for dementia,~     depression, and PBA.~      The second group of patients (n= 280) was seen by non-dementia specialists in the community~     and received usual care which did not include comprehensive assessment or treatment of~     underlying metabolic derangements or maximal utilization of currently available medications.~      This study, evaluating date from a larger cohort (n>800) of specialist-treated~     cognitively-impaired patients, will further examine the hypothesis that a comprehensive~     dementia treatment protocol yields cognitive stabilization and/or improvement using already~     available dementia drugs when compared with usual community care.~   "
15047|NCT02860325|"~     Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS)~     and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive~     pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume~     (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient~     discomfort, favouring fighting the machine, and increases the risk of air trapping and~     lung overdistension even in patients with non-invasive ventilation (NIV).~      Recently, a new modality of synchronization has been available for pediatric and neonatal~     use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic~     electrical activity (Edi) as a signal to start the rise in pressure of the ventilator, and~     to adjust the tidal volume and the inspiratory time (cycling off) to the patient needs,~     breath by breath.~      The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities~     (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring~     prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum~     cytokines concentration, reduces the need for oxygen and respiratory support, and if it~     increases the probabilities of survival without bronchopulmonary dysplasia (BPD).~   "
15048|NCT02860312|"~     Patients on chronic hemodialysis present severe physical dysfunctioning associated with a~     significant reduction of their muscle mass. These two parameters are associated with~     increased morbidity and mortality along with deconditioning and poor quality of life. There~     are several studies- usually short term, single center uncontrolled and underpowered- that~     have shown a significant improvement of the physical, metabolic and dialytic parameters.~      There are only few studies that have measured the impact of a long term intradialytic~     exercise intervention on a supervised manner. This is a multi-center controlled study~     examining the effects of intradialytic cycling on parameters of physical functioning, body~     composition, cardiovascular and nutritional status, immunological status and quality of life~     in a group of clinically stable hemodialysis patients~   "
15049|NCT02860299|"~     In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no~     leakage of the lock into the bloodstream should have been seen. Lock leakage could have~     particularly serious, and especially clinical, repercussions in these patients who already~     have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this~     study is to investigate the leakage of locks into the bloodstream by measuring, before and~     after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings~     will complete safety data already collected in the VERROU REA study.~   "
15050|NCT02860286|"~     This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of~     tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to~     determine eligibility for the study will be performed within 21 days of the first planned~     dose of tazemetostat.~      In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1~     status will be treated and undergo pharmacokinetics (PK) blood sample collection after a~     single tazemetostat 800 mg.~      Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant~     mesothelioma.~      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity~     or withdrawal of consent, or termination of the study. Response assessment will be evaluated~     after 6 weeks of treatment and then every 12 weeks thereafter while on study.~   "
15051|NCT02860273|"~     In this study the investigators will determine whether the use of High Flow Nasal Cannula~     Oxygen during test enhances exercise performance in COPD patients on a treadmill.~   "
15052|NCT02860260|"~     The aim of this study is to show for the first time that treatment with intravenous~     fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases~     in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.~      The analysis of the recovery of functional and cognitive abilities as well as mood at 3~     months will allow us to study the impact of BDNF on these parameters. Thus, depending on the~     results obtained, circulating BDNF could serve as an early marker of these.~   "
15053|NCT02860247|"~     This study aims at determining within a short time (<3h) the susceptibility to clinical~     isolates of E. coli to the major antibiotics directly from positive blood cultures.~   "
46380|NCT02449928|"~     Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with~     other solution, in order to make clear whether can improve the prognosis.~   "
15057|NCT02860195|"~     A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine~     the presence of vapor of alcohol in insensible perspiration.~      One of possible application would be a continuous and non invasive monitoring of drinking~     behavior. To investigate the validity of this method, it's necessary to compare Transdermal~     Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations~     and breath Alcohol Concentrations provided by reference methods.~      The purpose of this study is to identify the kinetic of alcohol concentration in blood,~     exhaled air and sweat after alcohol ingestion.~   "
15058|NCT02860182|"~     Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and~     severe (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical~     outcomes have improved with the development of surgical techniques, but the postoperative~     mortality remains high (15-30% at 30 days). Endovascular approach with the deployment of~     endoprosthesis sealing the proximal intimal tear is an attractive minimally invasive~     technique, which can represent an alternative to surgical repair especially in high risk~     patients.~   "
15059|NCT02860169|"~     This study aim to adapt and test a novel indication of motivation in participants with cold~     & flu using the Picture Surfing Task (PST). The purpose of this task, in both healthy~     participants and those with cold & flu, will be to provide a measure of: 1) change in~     general motivation, 2) change in cold and flu-specific motivation, and 3) any change in~     general tendency to exert force to serve as a control.~   "
15060|NCT02860156|"~     This is a multicenter clinical trial of a cross section of HIV+ patients with and without~     diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100~     HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers,~     phenomapping, metabolomics, cMRI, echocardiography to determine characteristics unique to~     this patient population.~   "
15061|NCT02860143|"~     A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to~     adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare~     the time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the~     capnograph C. Compare the incidence of missing or poor quality readings between the RVM and~     the capnograph D. Compare RR readings between the RVM and the capnograph (during periods~     with adequate data quality on both devices) E. If RMV can identify respiratory obstruction.~     Capnography~   "
15062|NCT02860130|"~     The purpose of this research is to determine if an investigational new drug solution called~     Prismocitrate 18 lengthens extracorporeal circuit life in acute kidney injury (AKI) patients~     treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT~     treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who~     receive CRRT treatment with no anticoagulation.~   "
15063|NCT02860117|"~     The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in~     the control of pain intensity, the impact on the consumption of opioids and observe the side~     effect profile in patients suffering from great extent of burns.~   "
15064|NCT02860104|"~     The investigators will perform this study to prospectively analyse the clinical outcome~     after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under~     ultrasound (US) guidance.~   "
15065|NCT02860091|"~     The main objective of this proposed investigation is to evaluate blood ropivacaine~     concentrations in infants and toddlers following the initiation of, and over the course of,~     continuous paravertebral nerve blockade using ropivacaine infusion for postoperative pain~     control following esophageal atresia repair procedures that include posterior tracheopexy.~      Continuous paravertebral infusion of ropivacaine is the current standard of practice for~     this surgical population at the investigators' institution and, as such, this study does not~     aim to alter the current standard clinical care received by participants but rather evaluate~     the blood concentrations of ropivacaine as it is routinely used.~   "
15066|NCT02860078|"~     Qualitative and quantitatively evaluate the pain control and incidence of adverse effects in~     patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural~     puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and~     location of the sacral epidural space. A group will be submitted to epidural corticosteroid~     infiltration associated with local anesthetic with the use of fluoroscopy for locating the~     sacral epidural space, which is currently the gold standard for this technique, while in~     another location group will be held with the use of ultrasound.~   "
15067|NCT02860065|"~     The purpose of this study is to compare the effect of low and high dose CPC-201 on brain~     function including cerebral acetylcholinesterase (AChE) activity measured by positron~     emission tomography (PET).~   "
15068|NCT02860052|"~     This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be~     conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea~     pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the~     interdigital areas and all affected and immediate surrounding areas of one or both feet once~     daily for 2 weeks, followed by a 4-week post-treatment observation period.~   "
15069|NCT02860039|"~     This phase II randomized trial studies how well high dose flu vaccine works in treating~     children who have undergone done stem cell transplant. Higher dose flu vaccine may build a~     better immune response and may provide better protection against the flu than the standard~     vaccine.~   "
15070|NCT02860026|"~     This clinical trial will compare the growth and tolerance of infants who consume an~     investigational cow's milk-based infant formula to those who consume a marketed cow's~     milk-based infant formula through approximately 4 months of age.~   "
15081|NCT02859883|"~     The monitoring and prognosis of patients with familial polyposis adenomatous rests on~     analysis of the transitional mucosa at the anal margin and especially on the tracking,~     characterization and resection of lesions of dysplasia type of high grade at the duodenal~     level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are~     used. The FUSE technology allows the simplification or even the improvement of patient~     surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a~     second screen to enlarge the field of view may allow both analysis of duodenum and the main~     and accessory papilla with one single endoscope and to decrease the number of omitted~     lesions .~   "
47701|NCT02432690|"~     This is an open label, single-arm, phase II study. The study population is adult patients~     with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.~   "
15071|NCT02860013|"~     There are two main aims in this study. The first objective is to evaluate whether a~     particular telehealth solution, in addition to standard treatment and care, lead to a~     significant decrease in the mortality and an increase in health related quality of life for~     patients suffering from Heart Failure that may benefit from telehealth compared with only~     standard treatment and care. The second objective is to examine the additional costs of the~     telehealth solution and assess whether this solution is a cost-effective way to care for~     patients with Heart Failure across patients and municipality districts.~      It is hypothesized that telehealth care will increase patients quality adjusted life years~     compared to usual practice, since no difference in mortality and a higher health related~     quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in~     the number of admissions and readmissions to hospitals and a 30% reduction in the number of~     outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to~     whether these savings are offset by other costs such as more visits to general~     practitioners, community care or the implementation costs.~   "
15072|NCT02860000|"~     This phase II trial studies how well alisertib with or without fulvestrant works in treating~     patients with endocrine-resistant breast cancer that has spread to other places in the body.~     Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of~     estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving~     alisertib with or without fulvestrant may be better in treating patients with breast cancer.~   "
15073|NCT02859987|"~     Peripherally Inserted Central Catheter (PICC) are intravascular devices used on patients~     undergoing IV therapy. Insertion of these catheters can be achieved either by using the~     anatomical landmarks for the veins or using ultrasound guidance. The guidelines recommend~     the use of ultrasound guidance for central venous access catheterization to facilitate~     central venous cannulation (CVC) and to reduce the risk of complications, but the scientific~     evidence is limited and heterogeneous.~      This is a prospective randomized clinical trial in adults patients requiring peripherally~     inserted central catheter (PICC) placement for intravenous therapy.~      The principal aim of this randomized clinical trial is to evaluate the effectiveness of~     ultrasound-guidance technique for successfully peripherally central venous catheterisation~     in the first attempt versus landmark method, in the context of PICC cannulation.~      Patients are randomized (1:1) in two groups: Control arm (landmark technique) versus~     Experimental group (ultrasound guidance technique). In order to avoid expected biases the~     investigators stratified the cases by difficulty for venous cannulation. Crossover was~     allowed if catheterisation could not be reached after two unsuccessful venipunctures, to~     prevent suffering of the patients and troubles in its care.~   "
15074|NCT02859974|"~     Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction~     (VCD) is a laryngeal breathing disorder that has several potential causes. In some~     individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack,~     but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be~     devastating, leading to harmful, invasive, and ineffective treatments over a period of~     years. Numerous anecdotal reports indicate that several behavioral techniques, may be~     surprisingly effective and even curative. However, data are lacking. The form of respiratory~     retraining technique tested in the current study educates people with PVFMD about breathing~     and teaches them a number of breathing exercises specially designed to restore normal~     breathing patterns.~      This case series study will use a dyspnea perception questionnaire, patient daily logs, and~     physiological measurements of heart rate and breathing to examine whether this form of~     therapy can improve exertion-induced PVFMD symptoms.~   "
15075|NCT02859961|"~     This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety,~     and tolerability of the strategy of shifting clinically stable patients receiving~     suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral~     suppression for 48 weeks following study entry.~      Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO~     140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of~     existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one~     week overlap at the end of the treatment in subjects who do not experience virologic~     failure.~   "
15076|NCT02859948|"~     Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and~     best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.~   "
15077|NCT02859935|"~     The purpose of this randomized controlled intervention study at the STI outpatient clinic of~     Amsterdam is to answer the following questions : Does a personalised behaviour intervention~     comprising of targeted in-depth screening on mental health problems and drug use and, in~     case identified, subsequent linkage to care increase help seeking behaviour, and decrease~     risk behaviour in MSM who are at high risk for STIs and HIV?~   "
15078|NCT02859922|"~     The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal~     Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the~     LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in~     their structural design.~   "
15079|NCT02859909|"~     The main purpose of this study is to assess the efficacy and safety of BT595 in adult~     subjects with chronic ITP. The primary objective of this study is to determine the rate of~     subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at~     least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at~     least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in~     addition to further efficacy assessments, are to evaluate the safety of BT595.~   "
15080|NCT02859896|"~     Primary Objective:~      Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid~     hormone (iPTH).~      Secondary Objectives:~        -  Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol)~          capsules.~        -  Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration~          of Hectorol®.~   "
15090|NCT02859766|"~     This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of~     free and vascular endothelial growth factor (VEGF)-bound abicipar following single and~     multiple intravitreal injections of abicipar pegol in treatment-naïve patients with~     neovascular age-related macular degeneration (AMD).~   "
15082|NCT02859870|"~     The coloscopy is considered as the gold standard for screening and resection of colorectal~     adenomas. However the literature reports that the rate of omitted adenoma is still high (24~     to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view~     with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre~     has demonstrated the feasibility with a significant improvement of the rate of detected~     adenomas. This first study in France concerning this technology has the objectives to~     demonstrate the feasibility in France, the safety and to compare the rate of detected~     adenomas with data of the literature.~   "
15083|NCT02859857|"~     The objective of this study is to characterize the safety profile and determine the maximum~     tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according~     to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with~     advanced solid tumors. Secondarily to assess the preliminary antitumor activity of BXQ-350~     in solid tumors and recurrent high grade gliomas.~   "
15084|NCT02859844|"~     Many patients with neurological diseases suffer from neurogenic lower urinary tract~     dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency~     with or without incontinence and voiding dysfunction. In addition, the upper urinary tract~     may be jeopardized because of high intravesical pressure caused by detrusor overactivity~     with concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment~     of NLUTD is a challenge since conventional conservative therapies often fail and more~     invasive treatments such as intradetrusor onabotulinumtoxinA injections, bladder~     augmentation and urinary diversion have to be considered. Neuromodulation therapies~     including tibial nerve stimulation (TNS) may be alternative non-invasive treatment options.~     Indeed, TNS is an effective and safe treatment for idiopathic overactive bladder proven in~     randomized controlled trials (RCTs), but its value in neurological patients is unclear. In a~     recent systematic review, the investigators found evidence that TNS might become a promising~     treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently~     needed to reach definitive conclusions. However, the investigators study will be the first~     adequately sampled and powered, randomized, placebo-controlled, double-blind trial assessing~     transcutaneous TNS (TTNS) for NLUTD. This trial will provide significant insights into the~     efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is~     really effective in the neurological population, the investigators findings would completely~     revolutionize the management of NLUTD in daily clinical practice. Moreover, this~     interdisciplinary trial will relevantly influence the neurological and urological approach~     in the management of NLUTD promoting future collaborative projects improving patients'~     medical care and underlying the pioneering role of Switzerland in the rapidly developing and~     ambitious research field of neuro-urology.~   "
15085|NCT02859831|"~     Fusarium are microscopic filamentous fungi that live as saprobiontics in outside~     environments. They are found in the soil, the air, in water and on numerous plants. The~     frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd~     most frequent invasive mycoses. Most cases have been reported in the United States, in~     France, in Italy and in Brazil. A few epidemiological studies have shown the role of water~     in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on~     the role of water in the transmission of mycoses in hospitals. The aim of this prospective~     study is to describe, in time and pace, the contamination by Fusarium sp. in the water of~     two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and~     major works (reconstruction of a hospital). In each hospital, one reconstruction site will~     be compared with a site not under reconstruction (control).~      Water samples will be taken from the rooms of hospitalized patients.~   "
15086|NCT02859818|"~     Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary~     management of type 1 diabetes for adolescents, favoring their adherence and improving their~     quality of life and metabolic control. Six pediatric diabetes teams have engaged in action~     research to build a regional ETP program based on social cognitive theory of Bandura,~     assuming that the learning strategies of theory, applied in ETP program, should strengthen~     self-efficacy of adolescents with type 1 diabetes, which could induce an improvement~     behaviors adherence, quality of life and physiological profile of participants about 6~     months post-inclusion in the program.~      Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a~     cohort of adolescents with type 1 diabetes who followed a therapeutic education program~     based on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary~     objectives are to describe the evolution of 6 months of glycemic control, behavior of~     adherence, quality of life and other components of social cognitive theory for this~     population, to explore the effects of socio-cognitive profile on adherence, quality of life~     and glycemic control among adolescents with type 1 diabetes followed this program.~      Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who~     participated in ETPACAP program, consisting of three components:~        -  A quantitative component: collection and analysis of changes over 6 months of~          self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);~        -  A qualitative component: interviews with 32 participants at M0, M3 and M6 on the~          socio-cognitive factors according to Bandura (analysis continues theming);~        -  An integrative component, exploring the effects of the components of social cognitive~          theory on adherence, glycemic control and quality of life of adolescents with type 1~          diabetes cohort.~      Expected results: This research is expected to bring new knowledge about the ETP programs~     and the adolescent cohort studied to make an improvement and adjustment of educational~     sessions relevant to the needs and expectations of this population.~   "
15087|NCT02859805|"~     The objective of this study is to validate a diagnostic tool severity of these common~     non-motor manifestations, disturbing and little recognized as a self-questionnaire. This~     assessment tool used on different subgroups of patients (free from any treatment at an early~     stage of the disease and the stage of motor complications) will better understand the~     natural history of the non-motor fluctuations (FNM)~   "
15088|NCT02859792|"~     The study will be conducted in two steps:~        1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel~        2. Estimation of the probability of response associated to the MED.~      Each step has a main objective:~      Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients~     with chronic SCI~      Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve~     spasticity vs placebo, in patients with chronic SCI.~   "
15089|NCT02859779|"~     Background: In type 1 diabetes, adolescence is often associated with deterioration in~     glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment~     compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to~     insulin. Therapeutic patient education (TPE) is the key to successful management of the~     disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the~     Mediterranean region in France, and the care teams implementing them wish to promote joint~     reflection with sick teenagers and families to identify needs and expectations of everyone~     on priority skills to develop, to promote better management of the disease and improved~     quality of life.~      Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to~     be developed during the educational sessions, to promote self-management of their disease~     and their treatment.~      Method: Four audio-recorded focus groups will be organized in all 10 clinical settings~     (adolescents, parents and health professionals). Thematic analysis will be carried out from~     the transcript of the focus groups.~      Expected results: The results will allow a joint reflection involving the participation of~     young patients, families, health professionals and the research team to build and implement~     new educational sessions that meet the identified needs. This action resulting from the~     research is expected to pool resources in different health facilities providing therapeutic~     education programs and to harmonize practices.~   "
15091|NCT02859753|"~     To date, the majority of studies that have evaluated the efficacy of microwave ablation~     (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and~     compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local~     recurrence and survival have been retrospective. There have been no prospective randomized~     studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume,~     the response after one session, local recurrence rates in the first year, complication rates~     and survival at 3 and 5 years for HCC lesions > 2 cm in patients with Child-Pugh A and B~     cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are~     equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for~     lesions > 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in~     retrospective studies.~   "
15092|NCT02859740|"~     The objective of this study is to demonstrate the validity, the reproducibility and the~     coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM)~     mobility scale questionnaire in adults with lower-limb amputations.~   "
15093|NCT02859727|"~     This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor,~     to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI that~     already participated to the CDZ173X2201 study. The study is open-label designed to establish~     the long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target~     population.~   "
15094|NCT02859714|"~     Previous studies have shown geographic disparities in the detection of colorectal adenomas~     in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological~     deprivation index (EDI). On the other hand, the extremely low detection rates for these~     lesions in everyday practice before the implementation of organized screening for colorectal~     cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce~     socio-geographic inequalities in access to care and prevention. Yet, participation in~     screening also varies depending on the socio-economic level. In this context, the Côte-d'Or~     Polyps Registry, the only body to have data for the pre-screening period (before 2003), will~     make it possible to determine whether the implementation of organized screening led to the~     elimination of socio-geographic disparities concerning the detection of adenomas.~   "
15095|NCT02859701|"~     Single-centre, randomised, double blind, placebo controlled, single ascending dose study.~     The study will comprise of 2 parts: Part A (Cohorts 1 and 2); Part B (Cohorts 3 to 8).~   "
15096|NCT02859688|"~     Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene~     expression and lead to human diseases.~      However, unlike genetic mutations, epimutations can in theory be reverted through~     developmental epigenetic re-programing, which should limit their transmission across~     generations. Following the request for a parental project of a patient diagnosed with~     Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from~     the proband and his father, we had the exceptional opportunity to evaluate the question of~     inheritance of an epimutation. We provide here for the first time evidence for efficient~     reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has~     important implication for genetic counseling.~   "
15097|NCT02859675|"~     This study will improve our understanding of the mechanisms underlying anorexia in persons~     with Crohn's disease flare-ups. The practical spin-off from this research is potentially~     very important for the management of nutritional disorders associated with the disease by~     guiding diets towards foods that correspond to patients' preferences and/or to modified~     tastes. In addition, the results could lead to the identification of sensory markers that~     herald an inflammatory flare-up of the disease.~   "
15098|NCT02859662|"~     It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment~     syndrome.~      the aim of this study is to assess the qualities of a predictive score on the occurence of~     this syndrome after surgery of ruptured aortic aneurysm~   "
15099|NCT02859649|"~     According to the working memory model, which accounts for the organisation of working~     memory, the processing of non-meaningful gestures is not clear. Some authors suggest that~     working memory for non-meaningful gestures has the same characteristics as the phonological~     loop, made up of a phonological store and of a revival process (articulatory rehearsal).~     These characteristics are evidenced in memory span tasks, memory span which is itself~     determined by the duration of the memory trace and the time required to refresh the trace by~     subvocal rehearsal.~      The investigators therefore aim to set up a gestural working memory task, which is specific,~     simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first~     be an exploratory and descriptive study with healthy subjects.~   "
15100|NCT02859636|"~     The main objective is to evaluate the pronostic value of endothelial dysfonction in acute~     heart failure on a combined criteria associating cardiovascular mortality, nex~     hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2~     month and 1 year before acute heart failure.~   "
15101|NCT02859623|"~     Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease characterized by an~     aggressive clinical behavior and a poor prognosis. It predominantly affects elderly males~     with an average age of 67 years at diagnosis and the affected organs are usually the skin,~     bone marrow, lymph nodes and the central nervous system. Patients with BPDCN have poor~     outcomes with median overall survival (OS) ranging in the largest series of patients from 8~     to 12 months.~      Patient care must be defined in this pathology. Despite 40%-90% complete remission (CR)~     rates after initial chemotherapy, relapses are almost inevitable.~      The investigators have developed a national network to collect clinical and biological data~     of French patients diagnosed with BPDCN.~   "
15102|NCT02859610|"~     research on interactions between portal hypertension and microparticles~   "
15103|NCT02859597|"~     This study evaluates the ability of high flow nasal cannula versus nasal cannula to~     oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal~     procedures.~   "
15104|NCT02859584|"~     A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis~     (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum~     cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of~     decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol~     (SalivCort) in SAH.~      Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were~     measured~   "
15106|NCT02859558|"~     The study is being done to:~        -  start ART early in those recently or acutely infected with HIV-1~        -  see how starting ART as soon as the infection is found affects the amount of HIV-1 in~          blood and how well the body fights the HIV-1 infection~        -  look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells~          (infection-fighting cells in blood) after 48 weeks of ART~        -  see how early treatment for HIV affects the numbers of HIV-1 infection fighting cells~          (CD4+ and CD8+ T-cells) in blood~   "
15107|NCT02859545|"~     Chronic pain is a highly prevalent and costly health care problem. Yet, little is known~     about the optimal ways for health care providers and family members to respond to the~     distress expressed by people with chronic pain. The aim of the current study is to compare~     two models of responsiveness to identify responses that result in better functioning and~     adjustment. An experimental design will be used to test the extent to which emotional~     validation (e.g., an empathic response to distress) increases or decreases pain behaviors~     during physical activity. Romantic partners of individuals with chronic pain will be~     randomly assigned to receive validation or control training. Following training, people with~     chronic pain and their partners will engage in a discussion about pain and complete~     household tasks to examine the effects of partner training on communication, pain intensity,~     and pain behavior. Additionally, each individual in the couple will complete self-report~     measures after the discussion, after the household tasks, and one-month following the~     laboratory visit.~   "
15108|NCT02859532|"~     Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a~     thrombus within the venous system, mainly the lower limbs. The clot structure directly~     influences both its location, but also its progressive profile expansion material or~     regression and embolic migration.~      Few data are available regarding the evolution of structural properties of thrombus after an~     acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into~     fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how~     the thrombus responds to forces which it is subjected.~      Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to~     study its evolutionary properties.~   "
15109|NCT02859519|"~     The primary objective of this study is to evaluate the efficacy of topical MOB015B in~     patients with mild to moderate distal subungual onychomycosis (DSO).~      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild~     to moderate DSO.~   "
15110|NCT02859506|"~     Today, we know that olfactogustatory alterations occur in cirrhotic patients before the~     liver transplant but no study has been conducted to show eventual disturbances after the~     transplantation able to explain modifications in eating behaviour. In parallel, the~     metabolic status, itself dependent on liver metabolism, influences food preferences and is~     modified after the transplantation as the liver recovers its ability to store glycogen, but~     is not able to inform the brain as the afferent nerve impulses have been suppressed. The~     innovative aspect of this project is to provide information on the importance of the liver~     in the regulation of energy homeostasis.~      The results of this study will improve our understanding of eating behaviour and~     olfactogustatory sensitivity and allow us to orient liver transplant patients towards~     appropriate diets.~   "
15111|NCT02859493|"~     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on~     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is~     a randomized, double-blind, placebo-controlled study. The administration of yeast will be~     local (vaginal).~   "
15112|NCT02859480|"~     This study is a prospective, randomized, open-label, single-center trial designed to compare~     the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL)~     rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary~     intervention with the newer drug-eluting stent.~   "
15113|NCT02859467|"~     Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for~     Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).~      Study Design: A single-blind randomized controlled trial was conducted on patients with FMS.~      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to~     an experimental group receiving kinesio taping and inhibitory treatment techniques, or to a~     control group for exercises and electrical stimulation therapy.~   "
15114|NCT02859454|"~     Background:~      Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus.~     It can cause voice changes, airway compromise, pulmonary lesions, and cancers. PD-L1 is a~     protein on cells. It may be able to stop or decrease the immune system s response to viruses~     such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1.~     Researchers want to see if Avelumab treats RRP and study its side effects.~      Objective:~      To see if Avelumab works in treating RRP and is safe.~      Eligibility:~      People ages 18 and older with aggressive RRP that has not responded to available treatments~      Design:~      Participants will be screened with:~      Medical history~      Previously collected tumor tissue~      Physical exam~      Blood, urine, and heart tests~      Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx,~      and upper windpipe.~      Before starting treatment, participants will have:~      Endoscopy under anesthesia. A sample of papilloma will be taken.~      Voice handicap questionnaire~      CT scans~      Apheresis: An IV is inserted into an arm vein. White blood cells are separated~      from the rest of the blood and stored for research. The rest of the blood is returned~      through the same IV or one in the other arm.~      Participants will get the study drug by IV every 2 weeks for up to 12 weeks.~      Participants will repeat the previous tests throughout the study.~      If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then~     every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses.~      Participants will be evaluated 30 days after their last infusion. They will then be~     contacted annually.~   "
15115|NCT02859441|"~     Objective: Von Hippel-Lindau (VHL) disease is an autosomal dominant heritable disorder in~     which multiple benign and malignant neoplasms and cysts of specific histopathologies develop~     in the kidney, adrenal gland, pancreas, brain, spinal cord, eye, inner ear, epididymis and~     broad ligament. The disease affects about 7,000 individuals in the United States. Retinal~     capillary hemangiomas (RCH) are the most common and often the earliest manifestation of VHL~     disease and may lead to significant vision loss. In some such eyes, inexorable progression~     of RCH leads to blindness and phthisis bulbi despite aggressive treatment. Levels of~     vascular endothelial growth factor (VEGF), a potent mediator of angiogenesis and vascular~     permeability, have been shown to be elevated in multiple cell types deficient in the VHL~     protein (pVHL). Platelet-derived growth factor (PDGF), which has an important role in~     stabilization of immature new vessels during angiogenesis, is upregulated in pVHL-defective~     cell lines and expressed in other pVHL-defective tumors. Anti-VEGF therapy alone had no~     beneficial effect on ocular VHL disease in two previous phase 1 studies. The objective of~     this study is to investigate the safety and possible efficacy of combination investigational~     treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and~     ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease.~      Study Population: Five participants with severe ocular VHL disease will receive the~     combination investigational treatment in one eye and will be followed for 104 weeks. Up to~     an additional two participants may be enrolled to replace participants withdrawing from the~     study prior to their Week 52 visit.~      Design: In this phase I/II, single-center, prospective, open label, non-randomized,~     uncontrolled, single group trial, one eye of eligible participants will be treated with~     investigational products, E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist.~     Participants will receive combination investigational treatment consisting of intravitreal~     injections of E10030 (1.5 mg in 0.05 mL) and ranibizumab (0.5 mg in 0.05 mL) every four~     weeks from baseline through Week 16 (totaling five treatments) and then every eight weeks~     through Week 48 (totaling nine treatments from baseline). Starting at Week 52, participants~     meeting criteria for a sufficient response will be eligible to continue to receive~     injections as needed as frequently as every 4 weeks through Week 92 in the treatment~     extension phase. All participants will be followed for 104 weeks.~      Outcome Measures: The primary outcome for the study will be safety of the combination~     investigational treatment, assessed by tabulation of adverse events reported through Week~     52. Secondary outcomes will include tabulation of adverse events at Week 104, and the~     following measures in the study eye at Week 52 and 104: the proportion of participants~     experiencing reduction in size of at least one RCH in the absence of other ablative~     treatment (assessed by fundus photography and fluorescein angiography [FA]); the proportion~     of participants experiencing moderate vision loss (defined as a loss of greater than or~     equal to 15 letters from baseline on Electronic Visual Acuity [EVA] testing); mean change in~     visual acuity; change in size of RCH (measured by fundus photography and FA); change in~     exudation (measured by fundus photography, optical coherence tomography [OCT] and FA);~     change in epiretinal proliferation, fibrosis or retinal traction (assessed by OCT and fundus~     photography); proportion of participants undergoing ablative treatment of RCH or ocular~     surgery; proportion of participants with successful ablative treatment of RCH; and the~     proportion of participants with appearance of one or more new RCH.~   "
15145|NCT02859051|"~     The purpose of this study is to determine if a preparation teaching intervention before IV~     insertion, taught by MEDi to children and their parents, will lead to lower levels of~     expected and experienced pain and fear and less distressing pain memories, as compared to~     children who receive standard care. In addition, it will be examined whether this~     preparation intervention will lead to greater parental self-efficacy, less anxiety, and less~     distressing pain memories as compared to controls.~   "
15116|NCT02859428|"~     Background:~      Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn~     more about how its symptoms change over time. They want to look for changes in the blood and~     cells of people with the most common forms of HSP that might allow them to better understand~     the disease.~      Objectives:~      To learn more about common forms of hereditary spastic paraplegia and find out how it~     progresses over time.~      Eligibility:~      People age 7 and older with SPG3A, SPG4A, or SPG31~      Design:~      Participants will have 1 two-hour visit each year for up to 5 years.~      At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a~     tool will remove a small piece of skin.~      At all visits, all participants will have a physical exam and blood drawn.~      At all visits, participants will do a few tasks like walking quickly and climbing stairs.~      Participants can give permission for their skin cells, DNA samples, and data to be used in~     other studies. The samples and data will have no identifying information.~   "
15117|NCT02859415|"~     Background:~      Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6~     hours a day for 7 straight days. Many of them had liver damage as a side effect. It was~     discovered that only people with certain genes got this side effect. Researchers want to~     test mithramycin in people who do not have those certain genes.~      <TAB>~      Objectives:~      To find the highest safe dose of mithramycin that can be given to people with chest cancer~     who have certain genes over 24 hours instead of spread out over a longer period of time. To~     see if mithramycin given as a 24-hour infusion shrinks tumors.~      Eligibility:~      People ages 18 and older who have chest cancer that is not shrinking with known therapies,~     and whose genes will limit the chance of liver damage from mithramycin~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Lung and heart function tests~      X-rays or scans of their tumor~      Liver ultrasound~      Tumor biopsy~      Participants will be admitted to the hospital overnight. A small plastic tube (catheter)~     will be inserted in the arm or chest. They will get mithramycin through the catheter over~     about 24 hours.~      If they do not have bad side effects or their cancer does not worsen, they can repeat the~     treatment every 14 days.~      Participants will have multiple visits for each treatment cycle. These include repeats of~     certain screening tests.~      After stopping treatment, participants will have weekly visits until they recover from any~     side effects.~   "
15118|NCT02859402|"~     Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The~     role of allogeneic stem cell transplantation have been demonstrated in these patients. This~     clinical trial is studying the efficacy and safety of busulfan plus fludarabine as~     conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and~     NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies~     including autologous transplantation.~   "
15119|NCT02859389|"~     Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits,~     reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive~     assessment is frequently implemented during therapy and continued into survivorship to~     monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at~     10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are~     comparable to or lower than patients without DS, however, these patients are at greater risk~     for treatment-related toxicities. Children with preexisting neurodevelopmental conditions,~     including DS, are systematically excluded from neurocognitive assessment on clinical trials,~     contributing to a gap in the investigators understanding of outcomes in these patients with~     preexisting neurocognitive vulnerability. The investigators propose a novel preliminary~     investigation of functional outcomes in children with DS and childhood leukemia. This study~     has implications for future treatment of leukemia patients with DS, and may generalize to~     leukemia patients with other predispositions or preexisting neurodevelopmental conditions~     (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).~      Primary Objective:~        -  To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia~          with Down Syndrome using a novel assessment approach.~   "
15120|NCT02859376|"~     The objective of this trial is to compare the analgesic effect of a single dose of oral~     sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular~     puncture) versus multiple doses of oral sucrose 24% administered two minutes before and~     during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks~     hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant~     Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual~     Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).~   "
15121|NCT02859363|"~     Fabry disease is an X-linked disorder of glycosphingolipid catabolism caused by a deficiency~     of the enzyme α-galactosidase A (α-Gal A), which leads to a progressive accumulation of~     globotriaosylceramide (Gb-3) in plasma and tissue lysosomes throughout the body. Lysosomal~     accumulation can result in lysosomal and cellular dysfunction, which leads to renal,~     cardiac, and central nervous system (CNS) complications.~      It is estimated that 1 in 40,000 males has Fabry disease, whereas the estimated prevalence~     in the general population is 1 in 117,000 people. Newborn screenings for both classical and~     atypical Fabry disease in Taiwan also revealed a markedly high incidence of 1 in 2,300 and 1~     in 3,000 newborns. Cerebrovascular variant Fabry disease may affect up to 4.9% of male~     patients and 2.4% of female patients with idiopathic stroke.~      The diagnosis of Fabry disease can be challenging due to the diverse signs and symptoms,~     different ages of onset, and variable timing and severity of progression. The importance of~     Fabry disease lies in the irreversible renal, cardiac, cerebrovascular, and neurological~     damage. An early diagnosis of Fabry disease is important for initiating symptom management~     and reducing life-threatening complications, as well as for early identification of other~     affected family members. Therefore, the present study would like to conduct further~     screening of high-risk group of early cerebrovascular involvement that is essential for the~     successful management of Fabry disease.~   "
15146|NCT02859038|"~     The purpose of this study is to answer the fundamental question, should the physicians~     choose Surgery or Chemotherapy (SOC 2) in advanced ovarian cancer?~   "
15620|NCT02852837|"~     The purpose of this study is to evaluate the tolerability, safety and the pharmacokinetic~     (PK) profile of daratumumab in Chinese participants with relapsed or refractory multiple~     myeloma (MM) who failed at least 2 prior lines of systemic therapy.~   "
15122|NCT02859350|"~     This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in~     healthy Equatoguinean adults, adolescents, children and infants who receive doses of~     0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared~     with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will~     also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the~     administration of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10^5 PfSPZ) under~     anti-malarial chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for~     safety, tolerability, immunogenicity and efficacy against controlled human malaria infection~     (CHMI).~   "
15123|NCT02859337|"~     Obese women are significantly more likely than their normal BMI counterparts to experience~     failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for~     testing a dose escalation strategy in an effort to provide improved efficacy from~     orally-dosed emergency contraceptives in obese women. More data is needed regarding~     emergency contraception containing ulipristal acetate. The overall project will be focused~     on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency~     contraception but this protocol registration is for the UPA aspect of the study procedures.~   "
15124|NCT02859324|"~     CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in~     combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who~     have progressed after or were intolerant to no more than 2 previous systemic therapies for~     unresectable HCC, or are naïve to systemic therapy.~   "
15125|NCT02859311|"~     One third of patients diagnosed with heart failure demonstrate left ventricular reverse~     remodelling and recovery of cardiac function following a period of medical therapy. These~     patients have an excellent long-term prognosis. Whether they need to remain on long-term~     medical therapy is not clear. The investigators will investigate the safety of therapy~     withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac~     function, in a randomised controlled trial.~   "
15126|NCT02859298|"~     Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of~     premature delivery (TPD), the most important complication and the leading cause of~     hospitalization during pregnancy has multiple origins which are seldom precisely identified.~      The standard medical examination for the detection of patients with TPD is the endovaginal~     ultrasonographic examination of uterine cervix (echography).~      Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging~     technologies with polarized light. The polarization is the spatio-temporal orientation of a~     wave's electric field. This light property, invisible with the naked eye, is sensitive to~     the morphological transformations of a tissue and the orientation of collagen fibers. Such~     tool would not require an extensive training and should provide an objective quantitative~     result with a sensitivity and specificity greater than conventional ultrasonography. This~     would be a considerable contribution to the health care of TPD, a real societal problem in~     Belgium, Europe and all over the world.~      The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the~     structural evolution, the density and the orientation changes of collagen fibers. A relevant~     scoring of collagen status might provide an alternative, and potentially objective and~     accurate quantifier of the time left before delivery.~   "
15127|NCT02859285|"~     The purpose of this research study is to learn about sexual function in postmenopausal women~     and to determine whether the use of topical clitoral application of estradiol improves~     women's libido, arousal, and orgasmic ability.~   "
15128|NCT02859272|"~     Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables~     pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital~     hiatus. POP is more frequent among women who had their uterus removed.~      We would like to investigate whether suspension of the top of the vagina during remowal of~     the uterus prevents subsequent POP.~      The purpose of the PhD project is therefore to describe validity, terminology, and operative~     performance of used suspension methods during benign hysterectomy in Denmark. Further, to~     investigate these suspension methods' possible association with pain, life quality,~     sexuality, pessary use, and POP .~   "
15129|NCT02859259|"~     An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529~     administered as BMS-663068 (Prodrug).~   "
15130|NCT02859246|"~     It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount~     of corneal filaments and improving symptomology in subjects with filamentary keratitis.~   "
15131|NCT02859233|"~     Postdural puncture headache (PDPH) is defined, according to the International Headache~     Society, as any headache develops within 5 days after a lumbar puncture. It worsens within~     15 minutes after sitting or standing and improves within 15 minutes after lying.~      For preventing PDPH, there are some uncomfortable practices for patients (fluid~     supplementation and bed rest) and expensive for hospital (time spend for information and~     management of fluid intake). Patients are usually advised by nurses. If bed rest is not~     effective in prevention of PDPH, fluid supplementation is not an advice based on any~     evidence but only on routine. By this trial, the investigators want to evaluate the~     scientific value of this advice, in the standard patient care.~      The primary objective of this study is to compare oral hyperhydration (2 liters during 2~     hours after lumbar puncture - the most common routine according to an internal pilot survey)~     versus no advice about the fluid intake to prevent the PDPH.~      The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.~   "
15142|NCT02859090|"~     It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed,~     HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological~     inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat.~     Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin~     lymphomas, and targeting this HSP at the cell surface using specific antibodies could~     constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the~     importance of these proteins in the development of lymphomas, their expression and their~     role in the activation of normal B lymphocytes and the normal development of germinal~     centres is not known.~      The expression of Heat shock proteins should vary among the different B lymphocyte~     populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells).~      The aim of this study is to establish an expression profile for heat shock proteins in~     populations of B lymphocytes in human tonsils~   "
15132|NCT02859220|"~     This study included 80 patients with end stage renal disease requiring dialysis treatment to~     evaluate two techniques for the determination of parathyroid hormone (PTH)~      Objective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH~     1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP =~     cyclase inactivating PTH) with kit Duo PTH Immunoradiometric Scantibodies allows an~     improvement in the therapeutic management of abnormal calcium and phosphate, with a better~     match to the targets of current international recommendations, followed by the conventional~     intact PTH assay.~      Primary endpoint:~      For each patient, a score will be awarded based on the number of criteria (including~     calcium, phosphorus and calcium phosphate product) in the target international guidelines~     :0-1-2 or 3.~      The primary endpoint will be the average scores in both groups at the beginning and the end~     of the study,~      Main secondary endpoints:~        -  Changes in the number of patients responding to international guidelines for each of~          the three parameters studied (serum phosphate, corrected calcium, phosphorus product)~          in the 2 groups,~        -  Evolution of Elecsys intact PTH Roche in the 2 groups,~        -  Salaries and changes in the number of drugs to normalize the phospho-calcium balance in~          each group received,~        -  cardiovascular events (morbidity and cardiovascular mortality),~        -  Total mortality.~      Statistical analysis:~      This is a randomized, two parallel arms. The investigators will compare the average number~     of criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis~     will be performed with the software Splus.~   "
15133|NCT02859207|"~     The primary objective of the study is to evaluate the effects of hepatic impairment on the~     pharmacokinetics (PK) of E2609 after a single dose administration.~   "
15134|NCT02859194|"~     ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure~     patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in~     respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure~     patients. V-A ECMO can also be used during lung transplantation, substitution of~     cardiopulmonary bypass, which can show sufficient performance during operation and better~     postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral~     artery, there is a pro blem of differential hypoxia which might influence coronary artery~     and head vessels. In this prospective study, the investigators are planning to put another~     ECMO catheter into internal jugular vein which takes a role of left to right shunt, to~     mitigate the hypoxia of coronary artery.~   "
15135|NCT02859181|"~     Protein requirements in active individuals have been suggested to be greater than the~     current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adolescents have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order~     to characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in adolescent, males using~     the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
15136|NCT02859168|"~     The purpose of this study was to show the immediate effects of myofascial induction on~     perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast~     cancer survivors suffering shoulder/arm morbidity.~   "
15137|NCT02859155|"~     Determine clinical and pathological factors associated with perioperative morbidity and~     mortality, and oncological outcomes after multivisceral en bloc resection in patients with~     colorectal cancer.~   "
15138|NCT02859142|"~     The purpose of this study is to learn if the combination of a study drug and patch is more~     effective in helping heavy drinkers stop smoking than just the patch alone The study drug,~     varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop~     smoking, but it is not known if the addition of varenicline to standard smoking cessation~     treatment with nicotine patches will help people stop smoking who are regular, frequent~     drinkers. This study is being done because cigarette smoking is the number one preventable~     cause of death and disease in the United States.~   "
15139|NCT02859129|"~     This study is intended to evaluate the potential 2-way reciprocal interaction between~     multiple doses of Epanova™ and a single dose of rosuvastatin~   "
15140|NCT02859116|"~     The purpose of this study is to help scientists understand how the gut senses ingested~     nutrients and what kind of processes take place for their absorption in order to establish~     the association with diabetes and other metabolic diseases Scientists need human specimens~     to study.~   "
15141|NCT02859103|"~     Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major~     depressive disorder (MDD), and it may impact how patients with depression experience reward.~     Understanding how anhedonia is related to the experience of reward may help improve how~     depression is treated. Computer tasks can be used to measure how reward is experienced, and~     these measures might be able to predict things like who is likely to become depressed, or~     who will respond to antidepressant medication. Studying the relationship between anhedonia~     and reward in patients with depression might also tell us something about how to improve~     diagnosis and treatment of other psychiatric disorders.This is an open label controlled~     treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas~     that may be related to how people perform on the tasks. The investigators goal is to use~     this information to help us find a reliable predictor that can be used to guide MDD~     treatment.~   "
15143|NCT02859077|"~     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in~     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use~     EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both~     EGFR mutation and BIM deletion polymorphism.~   "
15144|NCT02859064|"~     Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can~     be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide~     (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA~     approval to treat patients with metastatic NETs. The purpose of this study is to determine~     if treatment for patients with NETs can be optimized by combining these therapies.~   "
15149|NCT02858999|"~     Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis. Plasma~     cell leukaemia is defined as: at least 2,000 circulating plasma cells per µL for a blood~     leukocyte count higher than 10,000/µL or 20% of plasma cells for a leukocyte count less than~     10,000/µL. Plasma cell leukaemia can be either primary, when it constitutes the first~     manifestation of the disease, or secondary in the setting of relapsed/refractory multiple~     myeloma. Primary plasma cell leukaemia (PPL) is a rare disease, representing only 1 to 2% of~     all cases of multiple myelomas at diagnosis. As the annual incidence of multiple myeloma in~     France is about 4,000 new cases, an estimated 40 to 80 new cases of PPL would be observed~     each year.~      Few data are currently available in the literature concerning the pathophysiology and~     therapeutic management of PPL, and are derived from retrospective series based small numbers~     of patients. The prognosis of PPL in response to conventional chemotherapy remains poor with~     a median survival of 7 to 14 months. However, longer survivals have been obtained with~     intensive therapy and haematopoietic stem cell transplantation (allogeneic or autologous~     HSCT).~      The investigators propose to perform a prospective study of the management of patients with~     PPL under the age of 70 years, in combination with a laboratory study: 12 weeks of induction~     chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with~     Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles. Peripheral blood~     stem cell collection after mobilization by G-CSF will be performed after high-dose~     Cyclophosphamide chemotherapy. Autologous HSCT conditioned by high-dose Melphalan will be~     performed during the following month for all responding patients. During the 3 months after~     this first autologous HSCT, allogeneic HSCT with attenuated conditioning will be proposed in~     patients under the age of 66 years in complete remission with a suitable donor, and another~     systematic autologous HSCT will be proposed in all other patients. For all patients not~     treated by allogeneic HSCT, consolidation/maintenance therapy will be performed 3 months~     after the second autologous HSCT: 4 quarterly consolidations with~     Bortezomib-Lenalidomide-Dexamethasone (VRD) with maintenance by 2 months of Lenalidomide~     between these cycles, for a total duration of one year.~      The laboratory assessment will consist of blood and bone marrow samples systematically~     obtained at diagnosis for plasma cell phenotyping by cytometry, cytogenetics, FISH, study of~     the gene expression profile and SNParray. A DNA bank and plasma bank will be constituted.~     The investigators also propose to study residual disease by cytometry (after the first~     autologous HSCT, before and at the end of the consolidation/maintenance phase), as it~     increasingly appears to have a major impact on survival in multiple myeloma.~   "
15150|NCT02858986|"~     Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to~     reduce the time required to complete tasks in laboratory settings. This benefit derives from~     the addition of binocular depth perception cues when compared to two-dimensional (2D)~     systems. This year a '4K' laparoscopic system has become commercially available, so-named as~     it provides a high resolution 2D image with four times the number of pixels of 2D full high~     definition. The improved visualisation is likely to provide additional non-binocular depth~     cues. It is currently unclear to what degree improving the resolution of 2D systems can~     compensate for binocular depth cues.~      Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides~     benefits in simulated tasks when compared to the monocular vision provided by~     high-resolution 4K systems.~      Methods: Two experiments will be performed: 1) A laboratory assessment of 3D versus 4K~     laparoscopic systems against industry optical standards, 2) A study to assess the benefits~     to novices and expert surgeons of using 3D and 4K laparoscopic systems during laparoscopic~     simulator tasks. The primary outcome measure is number of errors during laparoscopic~     simulator tasks. The secondary outcome measures include: objective and subjective measures~     of picture quality, task completion time, side effects (such as eye discomfort) and~     cognitive workload during laparoscopic simulator tasks~      Impact: This study is a unique, first-of-its-kind investigation into two new surgical~     technologies, and is the first study to involve a 4K system. The uptake of three-dimensional~     systems has been curbed by financial cost and the limitations of early 3D technologies. This~     study aims to determine which system may be the safest, quickest and most cost- effective,~     in order to guide future investment and technological development towards either 3D or 2D~     systems. In addition, these systems may also aid in the learning curve of trainee surgeons.~   "
15151|NCT02858973|"~     This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203~     in healthy volunteers conducted at one study center in the United States~   "
15152|NCT02858960|"~     The aim of this study is to compare exercise capacity in COPD patients through two different~     systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The~     Venturi Mask (VM).~   "
15153|NCT02858947|"~     The aim of this study was to investigate the clinical effectiveness of direct resin~     composite restorations placed with different placement techniques (incremental or bulk) and~     with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich~     technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal),~     in a randomized controlled comparison.~   "
15154|NCT02858934|"~     The standard treatment for women with a relatively small breast cancer without arguments for~     involvement of the axillary lymph nodes, is breast conserving surgery followed by~     radiotherapy of the whole breast, often with a complementary dose to the operated area~     (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before~     the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered~     in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in~     quality of life. Randomized trials have shown that shorter schedules, delivering slightly~     more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical~     study, the investigators have tested such a short schedule and shown that it is equally safe~     and equally well tolerated as the conventional schemes. Other hospitals have examined (and~     still are examining) the safety and tolerance of even shorter schedules, delivering~     radiotherapy in 1 week.~      This clinical study involves delivering radiotherapy in 1 week and before the surgery in~     stead of following surgery. In the postoperative setting, it is often debatable which volume~     should be included in the boost. Often boost-volumes remain large because of uncertainties~     in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on~     imaging. This can result in smaller boost volumes. The surgery will follow shortly after~     termination of the radiotherapy, resulting in a very short treatment period.~      This study is an open study investigating the effect on quality of life of a very short~     preoperative radiotherapy for early breast cancer.~   "
15155|NCT02858921|"~     This study aims to determine which of 3 drug combinations best reduces the size of tumour~     prior to surgery for advanced melanoma and prevents the recurrence of melanoma after~     surgery.~   "
15156|NCT02858908|"~     The purpose of this study is to determine whether Tideglusib is safe and efficacious in the~     treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy.~     The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.~   "
15157|NCT02858895|"~     This is a single-arm, open-label, multicenter study in approximately 43 adults with primary~     (de novo) Glioblastoma that has recurred or progressed after failure of first-line therapy~     [according to Response Assessment in Neuro-Oncology (RANO) criteria]. Eligible subjects will~     receive intratumoral infusion of MDNA55 administered via convection-enhanced delivery (CED).~   "
15158|NCT02858882|"~     People living at Northern latitudes are at risk of suffering from vitamin D insufficiency~     due to low sun exposure and the risk may be even more pronounced among elite swimmers since~     indoor training further reduces sun exposure. In light of this, the investigators want to~     examine vitamin D status in young elite swimmers and if there is an association between~     vitamin D status and muscle strength.~   "
15621|NCT02852824|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     655130 in healthy male subjects following IV administration of multiple rising doses. The~     study will also explore safety and tolerability following a single IV administration.~   "
15159|NCT02858869|"~     This pilot trial studies the side effects of giving pembrolizumab together with stereotactic~     radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread~     to the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability~     of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation~     therapy that delivers a single, high dose of radiation directly to the tumor and may cause~     less damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery~     may be a better treatment for patients with melanoma or non-small cell lung cancer that has~     spread to the brain.~   "
15160|NCT02858856|"~     This is a pilot study that investigate efficacy and safety of Deciten granule on immunity of~     patients with breast carcinoma receiving chemotherapy.~   "
15161|NCT02858843|"~     The purpose of this research study is to find out if the combined therapy~     lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.~   "
15162|NCT02858830|"~     Studying patients with rare adipose tissue disorders may help the investigators to better~     understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and~     thus have an enormous impact on public health.~   "
15163|NCT02858817|"~     Single center, randomized, placebo-controlled, double-blinded trial using PfSPZ Challenge~     (NF54) under A/P chemoprophylaxis for immunization and PfSPZ Challenge (NF54) for repeat~     CHMI.~      A total of 30 adult, healthy, malaria naïve volunteers will receive three injections by~     Direct Venous Inoculation (DVI) of either placebo (n = 10), 51,200 PfSPZ Challenge (NF54) (n~     = 10), or 150,000 PfSPZ Challenge (NF54) (n = 10) under chemoprophylaxis with A/P at 4 week~     intervals. The placebo will be NaCl 0.9%.~      Ten weeks after the last dose of PfSPZ Challenge (NF54) for immunization, volunteers will~     undergo first CHMI and followed until asexual blood stage parasitemia, detected by~     quantitative real time PCR (qPCR) or thick blood smear microscopy. If parasitemic, they will~     be treated with A/P (used in this case as a standard treatment regimen). In the event of no~     parasitemia, volunteers will be followed until Day 28 post-CHMI and will not receive A/P.~      Forty-four weeks after the last immunization, a second CHMI will be administered to assess~     longevity of protection. All volunteers will be followed up to 28 days post-inoculation.~     Those developing parasitemia will be treated with A/P.~   "
15164|NCT02858804|"~     The purpose of this study is to:~        1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin,~          cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and~          dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma~          patients (age≤65 years);~        2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance~          regimens.~   "
15165|NCT02858791|"~     The investigators will investigate the interrelationship of macrophage migration inhibitory~     factor (MIF) and free T4 in patients with PAH.~   "
15166|NCT02858778|"~     A prospective randomized controlled trial studying the ordering of palliative care~     consultations in the emergency department (Ig) versus later palliative care consultations in~     the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with~     a 1:1 ratio.~   "
15167|NCT02858765|"~     The purpose of this project is to study the influence of light on sleep, wakefulness, EEG~     activity and cognitive performances. The study aim also to evaluate techniques for~     registration and analysis of the EEG over periods of time.~   "
15168|NCT02858752|"~     This project studies memory and attention in healthy children aged from 5 to 17 years. The~     processes investigated are short term memory (auditory and visual) and attention.~      To characterize these processes involved in childhood, neuropsychological and~     neurophysiological assessments will be performed (using Electro-encephalography measures,~     behavioural responses and questionnaires).~   "
15169|NCT02858739|"~     AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well~     as the long-term clinical results in terms of safety and efficacy of the polymer-free DES~     technology in all comers patients with an indication to percutaneous coronary intervention.~      PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac~     events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and~     ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC~     classification (19).~      PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR).~      STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective~     observational registry aiming to enroll a population of 1000 patients.~      STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last~     patient in the registry.~      CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years~     after the index procedure.~      PATIENTS SELECTION CRITERIA:~      This is an all comers registry and patient who will be enrolled have to meet the sequent~     criteria:~        -  Patient must be at least 18 years of age at the time of signing the Informed Consent~          Form after Biofreedom placement.~        -  All de novo lesion subsets are included.~        -  Patient must agree to undergo all required follow-up visits and data collection.~        -  Patient must have indication to percutaneous coronary intervention following:~             -  Stable angina or evidence of myocardial ischemia with stress echocardiography/~               myocardial SPECT/exercise test, or~             -  Unstable angina / non ST-elevation myocardial infarction~             -  ST-elevation myocardial infarction with de novo culprit lesion.~      EXCLUSION CRITERIA:~      The exclusion criteria must follow the most recent IFU which may include but are not limited~     to the following:~        -  Known intolerance to any of the device components~        -  In-stent restenosis~        -  Woman with childbearing potential~        -  Age < 18y/o~        -  Inability to provide written informed consent~      EFFICACY PARAMETERS: TLR and TVR up to 5-year follow-up.~      SAFETY PATIENT ORIENTED PARAMETERS: all cause mortality, any myocardial infarction, Stent~     thrombosis based on the ARC classification, up to 5-year follow-up and bleeding occurrence~     according to BARC classification. Data on dual antiplatelet therapy use will also be~     collected and analyzed according to duration and cessation modalities.~      Sample size justification: Being this an observational registry aiming at quantifying effect~     estimates without direct comparisons to other devices for coronary angioplasty, we relied on~     confidence interval profiling for sample size justification, without proceeding with formal~     power analysis. The main analysis will be an overall and comprehensive analysis and it will~     be planned the primary analytical approach of all-comers patients with coronary artery~     disease and indication to PCI. Accordingly, we computed that a target sample of 1000~     patients will enable the computation of reasonably precise 95% confidence intervals.~     Specifically, assuming a 8% MACE rate at 1 year (in keeping with RUDY study and LEADERS FREE~     trial design), confidence intervals computed with the adjusted Wald method would be 7.1% to~     9.6% for a 1000-patient sample (point estimate 80/1000 [8.0%]). Given that the registry aims~     to reflect real-world patients and practice, no prevision to limit or restrict patient~     enrollment is considered.~      Analytical plan: Continuous endpoints will be summarized by presenting the total number of~     patients, mean, standard deviation, median, minimum, and maximum. Tabulation of categorical~     parameters will include counts and percentages. The outcomes will be summarized as both a~     discrete and a continuous variable using the method described above. Survival analysis will~     be performed with the Kaplan-Meier method. Statistical inference will be based on the~     computation of 95% confidence intervals using the adjusted Wald method. Additional analyses~     will involve key subgroups defined according to baseline, lesion, and procedural features,~     with statistical significance set at the 5% 2-tailed level. Specifically, Student t, Fisher~     exact, and log-rank tests will be used for such bivariate analyses, whereas multivariable~     linear regression, logistic regression, and Cox proportional hazard analyses will be used to~     adjust for confounders.~   "
15170|NCT02858726|"~     2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in~     patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients~     will receive either CR845 or placebo after each dialysis session for eight weeks. The safety~     and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will~     also have pharmacokinetic assessments completed. Part B of the study will assess one dose of~     IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe~     itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part~     A.~   "
15171|NCT02858713|"~     Medical adherence to topical corticosteroid products in psoriasis patients is a main~     determinant for poor treatment effect.~      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso~     QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)~     (Teslo) can improve medical adherence among psoriasis patients treated with a topical~     calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).~   "
15172|NCT02858700|"~     After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP),~     the pediatrician must make a difficult decision quickly or not to prescribe additional~     examinations and / or hospitalize or not the newborn in order to administer parenteral~     antibiotics. This decision takes into account several contextual data, (clinical, biological~     and bacteriological clinical data) to be considered simultaneously. These information lack~     sensitivity and specificity.~      Therefore, the common attitude among newborns in many countries remains the achievement of a~     significant number of additional tests and the establishment, without a prior evidence of~     infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization.~     However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:~        1. one source to higher health care costs (hospitalization, additional examinations)~        2. Selection of the bacterial ecology of the newborn and neonatal services and~        3. stress for the newborn and parents~   "
15181|NCT02858583|"~     Research question In newborn infants requiring CPR, does CC superimposed by sustained~     inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous~     circulation?~      Overall objective: CC superimposed by sustained inflation will improve short- and long-term~     outcomes in preterm and term newborns.~      Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation~     (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC)~     compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated~     newborns.~   "
15182|NCT02858570|"~     TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national~     multi-center, with a total of 1,644 research participants stratified into 3 groups according~     to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum~     II - 1 to 10 years; Stratum III - less than 1 year old).~      BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate~     immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated~     to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the~     study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the~     comparator vaccine currently available for the National Immunization Program in the child's~     immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target~     age group of vaccination in routine public health services and will be available to the~     National Immunization Program as a strategy to ensure sustainability and self-sufficiency to~     vaccination policy.~      OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3~     months to 19 years of age, in relation to the vaccine against meningococcus C currently~     provided by the National Immunization Program. To evaluate the safety and reactogenicity of~     MenCC Bio-vaccine in patients from 3 months to 19 years old.~      SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate~     vaccine in a subset of survey participants, aged 11 to 19 years.~      STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years,~     attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de~     Janeiro (living in areas covered by the municipal units health participants) that fit in the~     study eligibility criteria.~      NUMBER OF CENTRES: Two Clinical sites.~      STUDY DURATION: Estimate of 19 months.~      INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in~     three age groups, with specific vaccination schedules. For the age groups I and II are~     applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3~     doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the~     National Immunization Program.~      OUTCOMES PRIMARY:~      Immunogenicity:~      Proportion of seroconversion defined by the seronegative status change (titles of~     bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of~     bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of~     post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.~      Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and~     the ratio of these securities after the full vaccination schedule by age stratum.~      Safety and reactogenicity: Frequency and intensity of adverse events solicited and~     unsolicited, which occurred 30 days after vaccination.~      SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in~     a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age~     escalation, with interim analysis of inter-layer security and approval by the Security~     Independent Monitoring Committee of progression to the next lower age stratum.~   "
15173|NCT02858687|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis~     strategy of tonsillitis after POC tests.~      The objective of this study is to implement a new diagnosis strategy relying on the~     hypothesis that a second pharyngeal swab would improve the etiological diagnosis of~     tonsillitis of at least 5%.~   "
15174|NCT02858674|"~     The objective of this proposal is to develop, implement, and test the effectiveness of a~     computerized clinical decision support system for hospitalized patients with heart failure.~      Aim 1: Develop an electronic health record (EHR) based search method that uses both~     structured data and natural language processing of unstructured text to identify~     hospitalized patients with heart failure while they are still in the hospital.~      Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical~     decision support system (CDSS) to support delivery of evidence-based care to hospitalized~     heart failure patients using human computer interaction methods.~      Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision~     support system (CDSS) on processes of care for heart failure patients who are hospitalized~     for other causes. As part of the evaluation, we will test two implementation strategies, one~     of which will introduce the CDSS as an interruptive alert to providers, the second of which~     will introduce the CDSS as part of a provider checklist that exists on the side of the~     screen for each patient.~   "
15175|NCT02858661|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of meningitis caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis~     strategy of meningitis after POC test.~   "
15176|NCT02858648|"~     The purpose of this study is to examine whether a behavioral lifestyle intervention using~     mobile smart phone technology for self-monitoring can lead to greater improvements in~     diabetes outcomes.~   "
15177|NCT02858635|"~     Suicide is a major health problem that causes annually a million death worldwide. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition and stressful condition. According to this model, individuals~     who carry a suicidal act when subjected to stress factors (environmental stress, depression,~     substance ...) are those which have a specific vulnerability.These vulnerabilities can be~     considered as clinical parameters (propensity to despair, aggressive and/or impulsive~     traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and~     cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly~     underpinned by genetic factors. The interest of current researches is to identify biomarkers~     that will improve the opportunities for early identification of subject with a risk for SB.~      The four goals of this project are in the continuity of previous works team:~        1. To determine whether combinations of the main serotonin-related genes may better~          contribute to the vulnerability to SB, than when they are considered independently.~        2. To assess whether the associations between these genes and SB are modulated by~          childhood trauma, life events and stress response associated with these environmental~          factors.~        3. To test the value of combined clinical, neuropsychological and genetic factor for~          suicide prevention, in a prospective study, in particularity impulsivity and gene gene~          interaction.~        4. To investigate the association between events in real life (using ecological momentary~          assessment) and emotional response and suicidal ideation.~      The investigators propose to use a multidisciplinary approach to answer these questions and,~     hence, be able to identify new prevention strategies for SB.~   "
15178|NCT02858622|"~     Alleviating pain in children undergoing renal transplant is extremely challenging. Large~     incisions as those of renal transplant (Gibson's incision) require special techniques of~     pain control that don't affect hemodynamics or renal function. Since the transplant incision~     doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control~     in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior~     abdominal wall together with the underlying parietal peritoneum.~   "
15179|NCT02858609|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis~     strategy of diarrhoea after POC tests.~   "
15180|NCT02858596|"~     Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term~     enteral tube feeding in patients with insufficient oral intake. Although peristomal site~     infection is often noted as the most common adverse event after PEG tube placements, it is~     seldom life-threatening and considered a minor adverse event. Feeding-related adverse events~     have been identified as the main cause of death after PEG, with up to 50% of postoperative~     early mortality (30 days) being attributed to aspiration pneumonia. This may be related to~     the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even~     though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of~     preventing GER. It has been more than a decade since semi-solid feeds were developed as an~     alternative to conventional liquid feeds to prevent feeding-related adverse events.~     Unfortunately, there is limited published literature on this topic despite the wide usage of~     this feeding method in Japan. Amidst the growing popularity of this method and the~     introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we~     initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in~     2014.~   "
15622|NCT02852811|"~     The aim of the study is to investigate if group education about the topic menopause to women~     in PHC can improve women's menopausal symptoms and reduce depression.~   "
15183|NCT02858557|"~     This clinical study is designed to evaluate the effect of two dietary patterns,~     Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and~     microbial parameters in patients after pouch surgery and to assess the effect of a personal~     tailored diet, based on microbial profile, on disease outcomes and generate a predictive~     model for future interventions.~   "
15184|NCT02858544|"~     The primary goal of this study is to provide clinicians with a brief, patient~     self-administer instrument yielding a single composite score that reliably correlates with~     objective findings on standardized neurocognitive assessment for concussion.~   "
15185|NCT02858531|"~     Epidemics and infectious diseases in general, punctuate much of the activity of an emergency~     service. The impact of winter infections is particularly important to vulnerable populations~     such as infant during bronchiolitis epidemics and the elderly during seasonal influenza.~     Each year, these epidemic phenomena lead to disorganization of emergency services and~     healthcare teams by lack of anticipation and organizational measures in particular to manage~     the approval of emergency services for the most vulnerable populations requiring~     hospitalization.~      For 2 years, the pediatric emergency department of St Etienne University Hospital has a~     decision support tool for the periods of winter epidemics. Through a retrospective analysis~     of Passages of Emergency summary, this tool provides an estimate of infants with~     bronchiolitis flow day to day, and the availability in real time of an abnormally high flow~     of patients to pediatric emergencies. These data can help to affirm that the epidemic begins~     in this hospital.~   "
15186|NCT02858518|"~     Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic~     blood flow. It is a public health problem with 600,000 to 1 million people involved in~     France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant~     risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The~     anticoagulant standard treatment helps prevent the occurrence of this complication.~      However, oral anticoagulation also exposes patients to an increased risk of bleeding. The~     bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED,~     ATRIA and scores Shireman and Charlson ...).~      moreover, in geriatric hospital care, every patient has a standardized geriatric~     assessment to assess and quantify functional capacity, autonomy, cognitive abilities,~     nutritional status, psychological state and its environment social.~      Thus, the objective of the investigators study was to determine the frequency of each item~     of each bleeding risk assessment score and geriatric assessment in patients 80 and older~     hospitalized geriatric ward in the department and with anticoagulant.~   "
15187|NCT02858505|"~     Anaemia is the most worldwide health problem affecting pregnant women in both developed and~     developing countries. During pregnancy there is an inconsistent increase in plasma volume~     and haemoglobin mass.~      Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman~     needs about 1000 mg of iron during pregnancy.~      Diet alone cannot give pregnant woman the daily required amount of the iron (about 27~     mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take~     a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin~     their pregnancy with low iron stores, particularly in the second and third trimesters, so~     prevention should start as soon as possible even before pregnancy to prevent depletion of~     iron store and further Iron deficiency anemia.~      Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia~     during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous~     sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with~     constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and~     vomiting.~      Iron amino acid chelates have been emerged to be used as agents for prevention and treatment~     of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy~     with minimal unpleasant side effects.~      Twin pregnancies have a significant role in perinatal morbidity due to increased risks of~     low birth weight and preterm birth. The iron requirement for twin pregnancy is probable~     double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is~     usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency~     anemia.~   "
15188|NCT02858492|"~     This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1)~     kinase inhibitor, in subjects with moderate to severe RA who are currently being treated~     with disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is~     to investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects~     with moderate to severe RA. In addition to the PK, a number of experimental and clinical~     endpoints will be employed to obtain information on the PD, and preliminary efficacy in~     subjects with active RA. Although no formal hypothesis will be tested, these endpoints will~     enable a broader understanding of the mechanism of action and potential for clinical~     efficacy of GSK2982772 in RA. After a screening period of up to 30 days, approximately 30~     subjects will be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks),~     followed by a follow-up period (28 days). The total duration of participation in the study~     will be approximately 20 weeks from screening to the last study visit.~   "
15189|NCT02858479|"~     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response~     to stimuli that normally are not) and spontaneous pain (occurring at rest, without~     stimulation).~      This pain is secondary to nervous system injury affecting the sensory system. The lesion is~     either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity~     and reorganization of brain activity.~      Previous studies in functional neuroimaging have focused on brain areas activated during~     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but~     it was not possible to conclude formally.~      The objective of this study is to understand the brain dysfunction that induces allodynic~     pain considering the deafferentation of each patient and possible cortical losses.~   "
15216|NCT02858128|"~     The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted~     magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results~     with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in~     patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile~     who could benefit from treatment with stereotactic body radiation therapy (SBRT) were~     selected and their responses to these techniques were rated.~   "
15190|NCT02858466|"~     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response~     to stimuli that normally are not) and spontaneous pain (occurring at rest, without~     stimulation).~      This pain is secondary to nervous system injury affecting the sensory system. The lesion is~     either at the nerve endings of the spinal cord or brain.~      It induces a loss of sensitivity and likely reorganization of brain activity that are~     causing pain and which are the subject of this study.~      Previous studies in functional neuroimaging has focused on brain areas activated during~     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but~     it was not possible to conclude formally. The authors failed to assess the part of the~     effect of the loss of sensory afferents (deafferentation) and the basal brain function.~      Indeed, the operation without any sensory stimulation is not known yet is the initial level~     of activity which is the benchmark for studying brain function during stimulation. The~     objective of this study is to understand what are the cortical systems of allodynic~     dysfunctional in patients compared with controls at baseline.~   "
15191|NCT02858453|"~     This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other~     urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants~     will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of~     the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125~     for 40 weeks.~   "
15192|NCT02858440|"~     The purpose of this study is to evaluate the immune response, safety and reactogenicity~     after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary~     vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age~     in Russian healthy children according to the Russian immunisation schedule~   "
15193|NCT02858427|"~     The study aims to determine the correlation between the cognitive inhibition impairment and~     the history of suicide attempt in elderly depressed patients.~   "
15194|NCT02858414|"~     This study evaluates the impact of highly active antiretroviral therapy on the size of the~     latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The~     activation state of the cells will be assessed, by measuring the activation of Akt, to~     determine its influence on the size of the viral reservoirs.~   "
15195|NCT02858401|"~     The primary objectives of this study are to evaluate the safety and tolerability of a 6-dose~     regimen of GS-9620 (at 1 mg, 2 mg, and 4 mg dose levels) in HIV-1 infected virologically~     suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of~     GS-9620 as measured by changes in plasma HIV-1 RNA.~   "
15196|NCT02858388|"~     The goal of the study is to investigate if the active agent of Sinuclean Nebules is~     efficacious in the treatment of pediatric exudative otitis media, comparing with saline.~      Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg,~     extracted from Ecballium Elaterium.~   "
15197|NCT02858375|"~     The study aims to assess and compare the pain in women suffering from provoked~     vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18~     months after treatment.~   "
15198|NCT02858362|"~     A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation with SMT~     C1100 (ezutromid) in Ambulatory Paediatric Male Subjects with Duchenne Muscular Dystrophy~     (DMD)~   "
15199|NCT02858349|"~     Subjects with stroke will have behavioral testing and brain imaging before and after a~     4-week control period and a 4-week exercise intervention.~   "
15200|NCT02858336|"~     Background:~      Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period~     stops for a temporary time. This is due to improper function of the hypothalamus. This is~     the part of the brain that directs the whole reproductive system. Researchers want to learn~     more about functional HA. They also want to learn how diet, exercise, and other factors may~     change women s menstrual cycles.~      Objective:~      To better understand functional HA.~      Eligibility:~      Healthy women ages 18 28 years old who:~      Have regular periods~      Exercise no more than 4 hours a week~      Had their first period at age 11 14~      Design:~      Participants will be prescreened over the phone.~      Participants will be screened with:~      Blood and urine tests~      Medical history~      Physical exam.~      Participants will have 9 or 10 visits over about 3 menstrual cycles. These include:~      Repeat of screening tests~      Questionnaires~      Exercise test~      Resting energy expenditure test: Participants fast overnight before the test. They lie on~     their back under a~      canopy for a half hour.~      Body composition test: This is done with a dual energy x-ray absorptiometry (DXA) scan.~      Pelvic ultrasound~      For two full-day visits, an IV is inserted into an arm vein. The IV takes a blood sample~     every 10 minutes for 8 hours.~      Participants will keep logs:~      Menstrual cycle log~      Diet log for three 4-day cycles~      Participants will receive test kits to complete at home:~      Daily blood and urine sample~      Ovulation~      Participants will take a daily iron supplement. They will wear a wristband that monitors~     activity 24 hours a day.~      Participants will stick to a special diet for two 5-day periods of time. They will complete~     two 4-day exercise programs.~   "
15217|NCT02858115|"~     During thoracic surgery, an excessive use of fluid results in pulmonary complications.~     Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation.~     The investigators hypothesized that the assessment by transesophageal echocardiography (TEE)~     of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict~     fluid responsiveness in patients receiving one-lung ventilation.~      This retrospective, observational, single center study was from January 2014 to December~     2015. The investigators included 105 patients requiring one lung ventilation lung resection.~     The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of~     crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min,~     remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an~     increase in the VTI above 15% after infusion of 500 ml of crystalloid.~   "
15218|NCT02858102|"~     This study aims to develop a program of systematic physical exercise maintained for at least~     12 weeks to normalize biomarkers of metabolic syndrome; improve neurocognition and social~     functioning; increase empowerment, self-esteem and self-efficacy and reduce self-stigma in~     individuals with severe mental disorder with metabolic syndrome.~   "
15623|NCT02852798|"~     This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as~     second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer.~   "
15201|NCT02858323|"~     Background:~      Platelets are blood cells that help blood clot. Some people have what is called~     thrombocytopenia. This means they have a low blood platelet count. They need platelet~     transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of~     these people. They become refractory. This means their platelet levels no longer increase~     after transfusions. Researchers want to study a procedure that detects HLA antibodies. They~     want to test how well it predicts how a person will respond to a transfusion. They want to~     see if it does this better than the procedure that is usually used.~      Objective:~      To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in~     people who get platelet transfusions. To test if this method better predicts response to~     platelet transfusion than the IgG solid phase immunoassay method.~      Eligibility:~      People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who:~      Agreed to have their specimens and data used for future research~      Had Class I HLA antibodies detected by the IgG method~      Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody~     result~      Design:~      For each participant, researchers will look at a small portion of their archived plasma~     sample. The samples were left over from prior HLA antibody tests.~      Participants samples will be analyzed. They will be tested to see if C1q-binding HLA~     antibodies are present. This will be done by solid phase immunoassay. Results will be~     compared with the past results of the IgG method.~      Participants data will be stored in database that s protected by password.~   "
15202|NCT02858310|"~     Background:~      Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers~     caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy,~     researchers take a person s blood, remove certain white blood cells, and insert genes that~     make them to target cancer cells that have the E7 protein. The genetically changed cells,~     called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want~     to see if this can help people.~      Objective:~      To determine a safe dose of E7 TCR cells and whether these cells can help patients.~      Eligibility:~      Adults ages 18 66 with an HPV-16-associated cancer, including cervical, vulvar, vaginal,~     penile, anal, or oropharyngeal.~      Design:~      Participants will list all their medicines.~      Participants will have many screening tests, including imaging procedures, heart and lung~     tests, and lab tests. They will have a large catheter inserted into a vein.~      Participants will have leukapheresis. Blood will be removed through a needle in the arm. A~     machine separates the white blood cells. The rest of the blood is returned through a needle~     in the other arm.~      The cells will be changed in the lab.~      Participants will stay in the hospital. Over several days, they will get:~      Chemotherapy drugs~      E7 TCR cells~      Cell growth factor~      Shots or injections to stimulate blood cells~      Participants will be monitored in the hospital up to 12 days. They will get support medicine~     and have blood and lab tests.~      Participants will have a clinic visit about 40 days after cell infusion. They will have a~     physical exam, blood work, scans, and maybe x-rays.~      Participants will have many follow-up visits with the same procedures. At some visits, they~     may undergo leukapheresis.~      Participants will be followed for 15 years.~   "
15203|NCT02858297|"~     Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of~     chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and~     was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral~     lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising~     therapeutic option. The investigators compared clinical effectiveness of Glucosamine~     combined with two topical corticosteroid regimens to that of topical corticosteroid alone in~     symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on~     expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.~   "
15204|NCT02858284|"~     The purpose of this study is to evaluate whether the TUG device is safe and effective in~     patients with primary open angle glaucoma or ocular hypertension.~   "
15205|NCT02858271|"~     Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and~     pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers~   "
15206|NCT02858258|"~     The primary objective of the the trial is to establish one of three study arms, as future~     standard based on the comparison of the investigator-assessed failure-free survival.~   "
15207|NCT02858245|"~     A prospective, open-label, and multi-centered feasibility registry.~   "
15208|NCT02858232|"~     Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that~     dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded~     with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell~     proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly~     re-infused. The previous research data showed that MASCT had the modest overall response and~     less adverse effects for Hepatocellular Carcinoma patients.~      The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.~   "
15209|NCT02858219|"~     The main objective of this study is to compare the efficacy of botulinum toxin injections on~     vestibulodynia pain compared to a group treated with a placebo.~   "
15210|NCT02858206|"~     This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent~     nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and~     pathological lymph node metastases rate in premise of lower toxicities in locally advanced~     esophageal cancer.~   "
15211|NCT02858193|"~     To investigate the bioequivalence between two formulations containing~     S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys) when administered as single~     oral dose in two consecutive study periods to healthy male and female volunteers under~     fasting conditions.~   "
15212|NCT02858180|"~     This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have~     advanced cardiac disease or advanced lung disease.~   "
15213|NCT02858167|"~     The purpose of this study is to define a reference population for FDG-PET neurological~     examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma~     (tumor in remission, low disabling chronic tumor).~   "
15214|NCT02858154|"~     This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to~     oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are~     scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC~     procedure uses humidified room air delivered by nasal cannula at higher pressures and will~     test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the~     current clinical standard of care. All the infants in the study will have a brief test~     period of about 3 to 4 hours with the HFNC before participants begin their standard clinical~     PSG for titration of oxygen by nasal cannula for treatment of OSA.~   "
15215|NCT02858141|"~     This data base has been set in order to gather oncogeriatric information from elderly~     patients with pancreatic cancer who underwent an oncogeriatric evaluation.~      ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and~     Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated~     Cancer Research Site).~   "
15219|NCT02858076|"~     Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause~     acute and dramatic vision loss for patients with diabetes, there is no current,~     evidence-based clinical guidance as to what treatment method is most likely to provide the~     best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial~     growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each~     provide the opportunity to stabilize or regress retinal neovascularization. However,~     clinical trials are lacking to elucidate the relative time frame of visual recovery or final~     visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic~     Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent~     with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including~     greater visual acuity improvement and reduced rates of recurrent VH as compared with saline~     injection. It is possible that a study with a longer duration of follow-up with structured~     anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to~     avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the~     other hand, advances in surgical techniques leading to faster operative times, quicker~     patient recovery, and reduced complication rates may make prompt vitrectomy a more~     attractive alternative since it results in the immediate ability to clear hemorrhage and to~     perform PRP if desired, often as part of one procedure. This proposed study will evaluate~     the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt~     vitrectomy + PRP and intravitreous aflibercept injections.~   "
15220|NCT02858063|"~     -  Selection of patient and preparation of questionnaires~        -  Presentation of the study by the doctor~        -  Verbal consent of participants (patient and Partner)~        -  Delivery of booklets~        -  Response to documents (questionnaires and written consent) at home, send by mail~   "
15221|NCT02858050|"~     The study will look at real-times adhernce monitoring with Portal-724 MEMS cap. It~     integrates medication bottle, Smart Cap, Pill Dispenser, Embedded Computer, Embedded~     Cellular Modem and Tamper Proof apparatus. This device is capable of transmitting pill~     dispensing events from the patient's home to the Cloud over Cellular and IP networks. The~     transmission is done in real time if cellular coverage is above 1-bar, but if cell is not~     available or if the signal is below threshold, then the device Store-and-Forward feature is~     automatically activated.. Patient will be randmized to real-time monitoring or to have~     monitoring data download monthly at each study visit while taking hepatitis C medications~   "
15222|NCT02858037|"~     HIV Open-label Prevention Extension (HOPE).~   "
15223|NCT02858024|"~     A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative~     Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine,~     Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine~   "
15224|NCT02858011|"~     In the last two decades, cash transfer (CT) programs have emerged as a popular approach to~     long-term poverty alleviation. While the main goal of cash transfer programs is to reduce~     poverty, they also have the potential to improve many development outcomes, such as health~     and education.~      While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs~     on poverty and food security and have, for the most part, found positive impacts, less is~     known about the impacts of CTs in Africa south of the Sahara, and, in particular, West~     Africa. Moreover, despite the fact that cash transfers have been shown to lead to decreases~     in poverty, improvements in household food security, and increases in health service~     utilization, impacts on children's nutritional status (including anthropometric measures)~     are generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and~     governments are left with the question of how to design social safety nets, such as cash~     transfers, to achieve greater impact on diet quality, health, and nutrition.~      The overall goal of this research is to generate evidence and knowledge on an integrated~     program implemented by the Government of Mali that includes a combination of cash transfers~     and targeted nutrition interventions. The information generated will inform program~     implementers and policymakers about best options to improve food security and nutrition~     among vulnerable groups and individuals in West Africa. Specifically, the main objectives of~     the research are~        1. To provide evidence on the contribution of integrated social transfer programs to~          enhancing household welfare, food security, dietary diversity, and maternal and child~          nutrition in West Africa.~        2. To test different features and combinations of cash transfers with targeted nutrition~          interventions, and assess their impact on food security and maternal and child~          nutrition and health outcomes in Mali.~        3. To generate knowledge regarding the pathways of impact of these different program~          packages, identify the most effective and efficient modalities in the context of Mali,~          and derive lessons learned for other countries in the region.~      The research entails two study designs: i) a repeated cross-sectional survey (baseline,~     midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to~     asses the program's impact on child nutrition and health outcomes; ii) a panel study~     following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of~     household welfare outcomes. The study will be conducted in the 96 communes where the~     Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso,~     Koulikoro, Segou, Mopti and Kayes.~   "
15225|NCT02857998|"~     A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523~     in Patients With Relapsed or Refractory Mature B-cell Neoplasms~   "
15226|NCT02857985|"~     The size of the infarct is particularly important prognostic marker. It is clearly~     established that the extent of the infarct is not only correlated to mortality, but also~     long-term adverse events. The evaluation of the infarct size at the acute phase of the~     disease is therefore an essential clinical tool to adapt the immediate treatment and~     follow-up of patients. It is therefore crucial to have techniques that are effective,~     precise, reproducible, and easily performed during the acute phase to quantify the size of~     the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the~     standard examinations for the evaluation of infarct size. However, these exams are difficult~     to perform during the acute phase of the infarct owing to difficulties in monitoring~     unstable patients and the limited availability of the apparatus. It is for this reason that~     the investigators would like to investigate the rotational angiography (RA), which is~     comparable to a scanner in its mode of action but does not require transfer of patients as~     performed using the same apparatus that used for diagnostic coronarography and therapeutic~     angioplasty. RA is a radiological technique that uses the system employed for coronagraph,~     and consists rotating the fixed C-Arm around the patient and acquisition of a series of~     images that are then reconstituted. The investigators propose to evaluate the size of the~     infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as~     possible after RA and the investigators hope to demonstrated that RA allows the measurement~     of an infarct as precisely as cardiac MRI.~   "
15328|NCT02856646|"~     The purpose of this study is to gather data on patients diagnosed with and treated for~     classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is~     rendered, as well as assess the outcome of those treatment options and their impact on~     quality of life. Additional analyses will also attempt to identify prognostic or predictive~     biomarkers~   "
15666|NCT02852239|"~     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral~     dose in subjects with severe renal impairment and end stage renal disease not on dialysis.~   "
15227|NCT02857972|"~     General objective:~      To assess the preference and performance in terms of satisfaction and acceptability as well~     as safety profile of a novel innovative design of menstrual hygiene device (Wondaleaf®)~     during the night for menstruating women by comparing it to prior experience of the usual~     hygienic product for menstrual control, i.e. sanitary pads.~      Specific objectives:~        -  To determine the preference of participants between Wondaleaf® and usual sanitary pads~          as a night use menstrual hygiene product.~        -  To determine the satisfaction of participants towards Wondaleaf® and usual sanitary~          pads as a night use menstrual hygiene product.~        -  To determine the acceptability of participants towards Wondaleaf® as a night use~          menstrual hygiene product.~        -  To determine the safety profile of the Wondaleaf®.~   "
15228|NCT02857959|"~     The purpose of this study is to observe the serological response to 1 or 3 weekly doses of~     benzathine penicillin G in patients with early syphilis.~   "
15229|NCT02857946|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals~     & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International~     GmbH, Germany) after a single oral dose administration of each to healthy adults under~     fasting conditions~   "
15230|NCT02857933|"~     The purpose of this study is to determine the optimal frequency and intensity of physical~     therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be~     randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy.~     Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation~     for children with cerebral palsy, including frequency (number of sessions per week and the~     number of weeks), intensity (how hard the patient works), and time (how many total hours) of~     rehabilitation treatment.~   "
15231|NCT02857920|"~     The aim of this study is the safety and efficacy of Bevacizumab plus natural killer (NK)~     immunotherapy to many kinds of recurrent solid tumors.~   "
15232|NCT02857907|"~     The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune~     senescence. Markers of immune senescence expression is assessed in a prospective cohort of~     renal transplant recipients the day of transplantation and one year after renal~     transplantation.~   "
15233|NCT02857894|"~     Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by~     vascular abnormalities of the walls of small choroidal vessels, reproducing the specific~     aspect of polyps (cluster aspect). PCV is one of the boundary-forms of age related macular~     degeneration.~      These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and~     occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients~     would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions~     have been induced by radiotherapy treatment and may show an increased sensibility to~     radiation in these patients.~      Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in~     relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic~     lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering~     the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it~     seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM~     gene.~      Considering the frequency of PCV worldwide, it seems important to identify the predisposing~     genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer~     prevention (reinforced protection against radiations, including light) and to develop~     therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular~     control of DNA).~   "
15234|NCT02857881|"~     Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology,~     characterized by a progressive corneal thinning. This disease leads to a bombing of the~     cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity~     sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL)~     and simple corneal de-epithelization are two common surgical technics aiming to slow the~     progression of this pathology. They consist in rigidifying the corneal structure in order to~     stabilize its deformation progression. Even though these technics are commonly performed,~     none of these strategies has proven their efficiency. The effects of CXL can be due to the~     superficial scarring reaction as well as the effects of corneal remodeling induced by the~     de-epithelization phase during a CXL procedure, and not due to the covalent links between~     collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition~     in the presence of Riboflavine De-epithelization may be an equally effective treatment, when~     compared to CXL, but without long term secondary effects. Its association with a therapeutic~     photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate~     its opacities in order to recuperate the transparency of the cornea) will aim to improve the~     regularity of the anterior corneal surface, thus allowing a better epithelial attachment~     (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of~     corneal biomechanics. PKT is a reliable technic; however it has not yet proven its~     efficiency in the treatment of keratoconus.~      The purpose of this study is to describe the effects of de-epithelization associated with a~     therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the~     proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1~     year, after an intervention of de-epithelization associated with therapeutic~     photokeratectomy.~   "
15235|NCT02857868|"~     The main purpose of this study is to evaluate the effect of varying degrees of impaired~     hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after~     a single oral dose.~   "
15236|NCT02857855|"~     The aim of this prospective randomized controlled trial is to evaluate the impact of high~     concentration supplemental postoperative oxygen therapy on short-term and long-term results~     of liver transplantation, particularly with respect to infections and biliary complications.~   "
15237|NCT02857842|"~     This study explores whether patients hospitalized with chronic obstructive pulmonary disease~     (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect~     by controlling the treatment by daily measurements of eosinophils.~   "
15251|NCT02857660|"~     The aim of the study is to determine the effect of 16 weeks of Whole~     Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity~     (SO) in community dwelling male subjects 70+ with SO .~      108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein~     (3) sedentary control group.~      WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar~     current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be~     adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg~     body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score~   "
16341|NCT02843425|"~     The goal of this clinical research study is to learn if eating canned, pre-cooked beans can~     help improve the levels of healthy bacteria in the digestive system and reduce the effects~     of obesity on cancer risk in patients with or without a previous history of colorectal~     cancer.~   "
15238|NCT02857829|"~     Achieving optimal concentration during cognitively demanding tasks is of immense human~     value. Despite our understanding of the important role that attention, working memory, and~     fluid intelligence play in professional success, and the huge individual differences in~     these constructs, the modulation of these cognitive domains has not been rigorously studied.~     From the widespread use of caffeine, to the more questionable and increasing use of~     prescription medications to achieve peak attention, the tremendous interest in achieving~     cognitive performance has driven individuals to experiment, often with prescription and~     illegal drugs. Herein, we aim to standardize and extend the study of attention modulating~     substances, to identify blends that achieve safe enhancements in attention and working~     memory. Specific to this proposal, we aim to develop SPRINT, a blend of natural and~     generally regarded as safe compounds to improve attention and working memory in normal,~     healthy individuals. SPRINT is composed of caffeine (100 mg), L-theanine (200 mg),~     vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).~   "
15239|NCT02857816|"~     To evaluate the NURO system for the treatment of OAB in drug naïve patients.~   "
15240|NCT02857803|"~     Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more~     ecologically valid context. The purpose of this study is to determine whether this~     methodology has more impact on stroke rehabilitation than a paper and pencil personalised~     program and conventional therapy, which is motor-focused.~   "
15241|NCT02857790|"~     Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy~     (HSRA) is commonly used to treat complex and calcified coronary artery stenoses.~     Theoretically, HSRA may have deleterious effects on the coronary microcirculation and result~     in peri-procedural myocardial infarction (Type 4a MI).~      This study is assessing the effects of HSRA PCI using serial multi-parametric stress~     perfusion cardiac magnetic resonance imaging (CMR) (1.5 Tesla MAGNETOM Avanto, Siemens~     Healthcare). The study will prospectively enrol up to 75 patients (minimum completed cohort~     of 50 patients) undergoing elective HSRA PCI and performing multi-parametric CMR at 3~     time-points: before HSRA, 1 week post-HSRA, and 6 months post-HSRA. Myocardial perfusion~     will be assessed using pharmacological stress with intravenous adenosine (140~     micrograms/kg/min) at each time point. High-sensitivity cardiac troponin (hsTn) and ECGs~     will be performed post-HSRA.~   "
15242|NCT02857777|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in elderly Japanese subjects and healthy younger adult~     Japanese subjects.~   "
15243|NCT02857764|"~     The purpose of the study is to estimate the incidence of below-knee lower extremity~     amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose~     co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i antihyperglycemic agents (AHA) overall and~     in the subgroup with high cardiovascular (CV) risk and to compare the hazards of below-knee~     lower extremity amputation in canagliflozin new users versus non-SGLT2i AHA new users.~   "
15244|NCT02857751|"~     The current study evaluates psychological and physical health outcomes for active-duty~     service members following participation in an established surf therapy program. Participants~     complete assessments before and after the surf therapy program, as well as brief assessments~     before and after each surf therapy session.~   "
15245|NCT02857738|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
15246|NCT02857725|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
15247|NCT02857712|"~     SGCs are rare (less than 1% of head and neck cancers) and include many malignant histotypes.~     SGCs are treated mainly with surgery, followed by radiotherapy in selected cases.~     Chemotherapy is reserved for palliative treatment of metastases or local recurrence but~     results in term of response rate are very low. Adenoid cystic cancer (ACC) is the most~     common SGC histotype observed in metastatic subjects while the other histotypes (non-ACC)~     such as mucoepidermoid cancer (MEC), salivary duct gland cancer, adenocarcinoma,~     myoepithelial carcinoma are more uncommon. A phase II trial with sorafenib carried out in 37~     subjects (19 ACC and 18 non-ACC) with recurrent and/or metastatic SGCs showed a response~     rate of 16% (11% in ACC and 22% in non-ACC). In preclinical models, VEGF seems to contribute~     to tumor aggressiveness and to distant metastatization of SGCs, in particular in ACC and~     MEC. Remarkably three confirmed partial responses, one ACC, one renal cancer and one lung~     cancer, on 36 patients were observed in a phase I study with Inlyta, a potent VEGFR~     specific-inhibitor approved by FDA as second line treatment for renal cancer. Based on these~     data, we want to test Inlyta in patients with relapsed and/or metastatic SGC.~   "
15248|NCT02857699|"~     A prospective cohort of 250 patients with solid tumours included in phase I clinical trials~     of targeted agents will be enrolled. Patients will be treated with MTA in mono therapy or in~     association with chemotherapy or other targeted agents in 4 large phase I centers.~      Patients from trials investigating chemotherapy alone will not be included. Quality of life~     will be assessed during the treatment period.~   "
15249|NCT02857686|"~     The safety and effectiveness of the mini-dose Bier block, a technique of i.v. regional~     anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated~     in the emergency department treatment of pediatric upper extremity fractures and~     dislocations.~   "
15250|NCT02857673|"~     Child maltreatment, particularly neglect, disproportionally affects low-income children with~     special health care needs (CSHCN) and has serious short and long-term consequences.~     Currently, few replicable, evidence-based preventive services exist for such families,~     particularly within the context of the patient-centered medical home. Child Abuse Prevention~     Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and~     protective factors for child neglect, has the potential to improve key parenting skills and~     overall wellbeing, ultimately improving outcomes for high-risk children. This study is a~     multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child~     neglect, adherence to recommended medical care, and family stressors and strengths.~   "
15273|NCT02857374|"~     This pilot clinical trial studies intravital microscopy in identifying tumor vessels in~     patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining~     sentinel lymph nodes through intravital microscopy before they are removed, doctors may~     learn specific information regarding how melanoma may spread to lymph nodes and other sites~     of the body.~   "
15252|NCT02857647|"~     An interventional prospective study on 200 bariatric surgery candidates from the Assuta~     Medical Center (AMC). The first 100 patients will be assigned to the control group and the~     later 100 patients will be assigned to the experimental group. All the participants will~     receive standard care, and only those participants who will assigned to the experimental~     group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the~     surgery date. The videotaped lecture will include information and guidelines of bariatric~     surgery preparation. All participants will complete Bariatric surgery knowledge~     questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric~     committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In~     addition, 20 participants will be recruited to a pilot study for the validation of the~     Bariatric surgery knowledge questionnaire.~   "
15253|NCT02857634|"~     Bladder cancer is one of the most common cancer worldwide and the second most frequent~     urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has~     improved tumor detection but with a high false positive rate. Indeed, the main limitation of~     the PDD is its lack of specificity, ranging from 35 to 66%. The association of this~     technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual~     wavelength illumination and detection, could improve the identification of tumoral lesions.~     The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique~     for the diagnosis of tumors bladders.~   "
15254|NCT02857621|"~     Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid~     in interstitial spaces. It is a progressive chronic disease and without appropriate~     management may result in serious complications. In Israel, patients are referred to~     physiotherapists certified in treatment for lymphedema. According to the International~     Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach.~     Amongst the different methods of lymphedema management, the use of compression is the only~     treatment that has shown to be effective in randomized controlled trials.~      The ISL recommends that patients with lymphedema in the lower limb ought to bandage their~     leg with multi-layer bandaging on a daily basis for a period of two to four weeks. A new~     classification system for compression bandages was recommended; pressure of <20 mmHg was~     categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong.~     In patients with leg edema, bandages with strong pressure were shown to be the most~     effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between~     35 and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of~     measurement instruments is currently the only realistic method for determining the actual~     pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor~     is it realistic in terms of time.~      Recent studies show that many healthcare professionals use inadequate sub-bandage pressure.~     No study so far has focused on therapists that are trained in lymphatic treatment. In spite~     of correct pressure bandaging importance, the question whether physiotherapists succeed in~     correctly applying it is left unanswered. The main purpose of this study is to evaluate the~     pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who~     treat lymphedema.~      34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each~     volunteer will receive a questionnaire concerning their self-perceived competence in the~     application of compression bandages. Afterwards, two practical trials will be held a week~     apart in which the subjects will be asked to apply bandages using strong and medium~     pressure. Using PicoPress®, pressure will be measured directly after bandaging and two hours~     later. Our hypothesis is that the majority of therapists will properly apply medium or~     strong pressure on the lower limbs.~   "
15255|NCT02857608|"~     Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the~     detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.~   "
15256|NCT02857595|"~     Behavioral lifestyle treatment for obesity produces clinically significant weight loss and~     corresponding improvements in disease risk and severity when delivered via in-person group~     and/or individual treatment sessions. Online versions have been developed in order to reduce~     costs. These programs typically include weekly weight loss lessons and tailored feedback on~     patients' weight loss progress. However, online programs often produce suboptimal outcomes~     compared to programs delivered in-person due to insufficient adherence to prescribed~     behavioral strategies, and a lack of objective methods for behavioral self-monitoring to~     support adherence. One approach to monitoring and improving adherence involves tracking~     patients' weight loss progress on a personalized nomogram (i.e., graph). The nomogram is~     based on a dynamic energy balance equation and depicts the expected weight loss over time if~     the participant is adherent to a prescribed goal for caloric intake and physical activity. A~     complementary approach to measuring and intervening on adherence involves the use of mobile~     technology to monitor eating behavior. The Bite Counter is a wrist-worn device similar to a~     wristwatch that measures the timing, frequency, rate, and duration of eating events by~     monitoring the wrist roll motion that occurs when food is brought to the mouth. By using~     mathematical models to calibrate the Bite Counter to the weight loss nomogram, it may be~     possible to identify the optimal number of bites that any given patient should take each day~     in order to facilitate weight loss. The purpose of the proposed study is to conduct a small~     randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy~     of adding weight loss nomograms and the Bite Counter to an established online weight loss~     program. A sample of 30 participants with overweight/obesity will be randomly assigned in~     equal proportions to one of three 12-week weight loss programs: (a) online behavioral weight~     loss treatment alone (OBWL), (b) online behavioral weight loss treatment plus the provision~     of weight loss nomograms with weekly feedback tailored to the nomogram (OBWL+N), or (c)~     online behavioral weight loss treatment plus the provision of weight loss nomograms with~     weekly feedback tailored to the nomogram and provision of a Bite Counter that can be used to~     alert participants when they are approaching their maximum number of prescribed bites per~     day (OBWL+N&BC).~   "
15257|NCT02857582|"~     Patients who have received antibiotics and thereafter developed diarrhea are investigated~     for presence of Clostridium difficile toxin. Primary treatment is given with oral~     metronidazole/vancomycin. In case of relapse, secondary treatment is given with either~     cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where~     secondary treatment with vancomycin fails cultured gut microbiota is given as final~     treatment. As an extension treatment, all failures were treated with cluttered gut~     microbiota through the upper route. In both cases As an alternative cultured gut microbiota~     may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with~     interview and stool collection for analysis of Clostridium difficile.~   "
15258|NCT02857569|"~     The study is a randomized Phase I/II trial aiming to evaluate the 6 month treatment~     tolerance defined as the related grade 3-4 toxicity event-free survival and clinical~     activity of the combination therapy IT ipilimumab + IV nivolumab.~      The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an~     internal control to interpret the results obtained in the IT ipilimumab arm.~   "
15259|NCT02857556|"~     The principal objective of this study is to qualify markers of oxidative stress in~     inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not),~     and patients with end-stage kidney failure (diabetic or not), who require dialysis. The~     evaluation of these markers will be done by the activation and localization of proteins~     implicated in vascular tone and oxidative stress in monocytes, correlated with the~     distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to~     describe their evolution under treatment, which could lead to interventional studies.~   "
15274|NCT02857361|"~     The study will look at whether it is preferable to administer two wafers simultaneously or~     separately.~   "
15275|NCT02857348|"~     The objective of this study is to compare the efficacy of a video game designed to~     recalibrate physician heuristics in trauma triage with a standard educational program.~   "
16364|NCT02843126|"~     The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK)~     immunotherapy to recurrent breast cancer.~   "
15260|NCT02857543|"~     The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA~     and MED in obese (BMI >95%) children ages 9-18 with hypercholesterolemia (>169 mg/dl) and a~     parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity~     Registry. When possible, in-person discussions or phone calls with their primary or tertiary~     care physicians will introduce eligible patients and their parents to the study. All~     eligible patients and parents will receive letters describing the study and requesting their~     participation. Subjects can choose not to participate in the study, and their health care~     will not be affected in any way. Subjects not participating will be asked if they are~     willing to answer a brief questionnaire about why they chose not to participate. The~     proposed study will be carried out for a total of 52 weeks. The investigators expect to~     recruit a total of 180 participants (30 children and 30 parents/guardians in each of the~     three groups). Each child and parent/guardian pair will be randomly assigned to either PB~     no-added-fat, AHA or MED.~   "
15261|NCT02857530|"~     Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic~     anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II~     phase, multi-center clinical research.~   "
15262|NCT02857517|"~     The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular~     endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.~   "
15263|NCT02857504|"~     One lung ventilation (OLV) has become a standard procedure for the vast majority of~     interventions in pulmonary surgery. It is used in both techniques: thoracotomy and~     videothoracoscopy (VATS).~      OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the~     investigators want to find out if there is any advantage with one or another.~   "
15264|NCT02857491|"~     Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana~     vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal~     detachment. This study will compare intravitreal injection of anti-vascular endothelial~     growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus~     is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge~     related complications.~   "
15265|NCT02857478|"~     The objective of this study was to assess the safety and appropriateness of a sunscreen~     product for use on sport users, under supervised outdoor-use conditions. The study was~     conducted under the supervision of a Board-Certified Dermatologist at an outdoor,~     chlorinated swimming pool facility.~   "
15266|NCT02857465|"~     To assess the efficacy of epidural dexamethasone administration, compared to placebo, in~     reducing local anesthetics consumption during labor epidural analgesia in parturient women~   "
15267|NCT02857452|"~     The evaluation of lupus patients must include several approaches, in particular disease~     activity and quality of life.~      The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to~     evaluate disease activity. It has the advantage of being inexpensive, easy to use in large~     cohorts and has been used in several studies. It has never been validated in French. The~     Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is~     specific to systemic lupus erythematous; it was developed from interviews with patients.~      This tool, validated in a British population, has never been validated in French.~   "
15268|NCT02857439|"~     What combination of ≤ 6 clinical variables will give the highest specificity for indicating~     significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?~      Although shoulder trauma is a common injury, there is no clinical decision rule to determine~     the necessity for radiography for these traumas. With this trial the investigators aim to~     develop such a rule to reduce the amount of radiographs without missing any significant~     injuries.~      The primary objective is to compose a set of clinical diagnostic criteria predictive of~     shoulder fractures or dislocations that would reduce the amount of radiographs without~     missing any significant injuries. A second objective is to determine if the clinical~     decision rule is applicable for triage use.~   "
15269|NCT02857426|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory~     Primary Testicular Lymphoma (PTL)~   "
15270|NCT02857413|"~     The aim of this study is the evaluation of the frequency of xerostomia and their management~     after radiotherapy in head and neck cancer.~      The quality of life of these patients is also analysed with European Organization for~     Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).~   "
15271|NCT02857400|"~     Prospective, open label, randomized and multicentric study evaluating the efficacy of an~     organized consultation return home compared to a current standard of care in patient~     hospitalized due to metastatic solid tumor cancer.~      Subject will be randomized (1:1) as described below :~      • Arm A (standard) : current standard of care ; connection documentation faxed to GP (~     General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO~     standard of care, organized consultation return home between patient, GP DESC (diploma of~     complementary specialized study) and patient's referent GP~   "
15272|NCT02857387|"~     Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins~     grouped under the name of  non-enzymatic post-translational modifications . They often~     correspond to the irreversible binding of glucose or other oses (glycation) or urea~     derivatives (carbamylation) on proteins and lead to the formation of complex compounds~     (post-translational modifications derived products, PTMD) that can accumulate in tissues and~     be responsible for deleterious effects. The specific role of these compounds in the~     pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and~     cellular mechanisms implicated.~      This project is based on the hypothesis that non-enzymatic post-translational modifications~     may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD~     could therefore constitute relevant biomarkers in this specific clinical situation.~      To explore these potential new biomarkers, the investigators designed a study in patients~     having experienced an acute coronary syndrome and followed during a year. The concentrations~     of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and~     evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac~     rehabilitation will be assessed.~      This should help to identify new (and non-traditional) biomarkers of coronary heart disease~     and determine some of the implicated pathophysiological mechanisms.~   "
15277|NCT02857322|"~     The experimental strategy is to develop a specific device about the anesthetic and surgical~     acts for a subject with a documented psychiatric condition and to benefit from surgery. This~     device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative~     phase. A nurse anesthetist will come into contact with the subject the day before surgery.~     This contact will be concomitant with the pre-anesthesia visit. She explained about the~     general organization of the arrival in the operating room. The interview will be a minimum~     of 15 minutes and beyond if necessary. This will be accompanying this the next day in the~     operating room in order to optimize its hospitality and installing the block, guide the~     subject through all the steps before falling asleep. Finally, even accompanying will be~     present upon awakening the subject in the recovery room.~   "
15278|NCT02857309|"~     The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM)~     in the heart failure population with ejection fraction ranging between 25 and 45%. The study~     is designed in an adaptive manner to ensure proper statistical significance and power of the~     primary efficacy evaluation.~   "
15279|NCT02857296|"~     The research project aims to analyze the implementation of a new health care system -~     alternative device to hospitalization and crisis home for people without home - whose~     objective is to provide the homeless and suffering from severe psychiatric disorders~     adequate care to prevent situations from seeking care or complication of their disease. This~     device, if it has the administrative and legal structure of the Twin Stop Health Care~     (LHSS), is based on the original concept of Soteria House. This will build tools for~     evaluating the performance of care device by a process evaluation describing and analyzing~     what activity involves the device, This research seeks to analyze the experimental device in~     the early stages of its implementation. The observation and analysis of the program period~     will adjust the management arrangements of the device. The data and conclusions from this~     research will identify the contributions and benefits of such a device and analyze the~     difficulties encountered in its implementation.~   "
15280|NCT02857283|"~     To investigate if low level ozone exposure will cause measurable inflammation in nasal~     cells.~   "
15281|NCT02857270|"~     The purpose of this study is to determine the safety of an extracellular signal regulated~     kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents~     in participants with advanced cancer.~   "
15282|NCT02857257|"~     Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human~     intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with~     symptoms of IBS and serve as their own controls. After an observation time of 4 weeks,~     patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by~     the duodenal route via gastroscopy. Two treatments are given within a 1-week interval.~     Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks).~     Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid~     (rRNA) analysis and bacterial functional parameters (microflora-associated characteristics).~   "
15283|NCT02857244|"~     The study team proposes to treat Parkinson's patients with gait difficulty with~     multidisciplinary approach of medications. Single medication treatment, such as the use of~     cholinergic-boosting anti-dementia medication targeting cholinergic deficiency to improve~     executive dysfunction and attention deficit, or the use of medication boosting the~     norepinephrine system, have not proven effective so far in treating the gait difficulty.~     Anti-anxiety medications, particularly the SNRI (serotonin and norepinephrine reuptake~     inhibitor) medications, which also ameliorate the norepinephrinergic deficiency, have not~     been studied except for one successful case report using duloxetine to treat primary~     progressive freezing of gait.~      Targeting multiple mechanisms at same time, such as the combination of a SNRI antianxiety~     medication (also boosting the norepinephrine system, such as duloxetine) with an~     anti-dementia medication correcting the cholinergic deficiency (such as donepezil), or~     targeting a new mechanism, such as the use of anti-GABAergic medication targeting the area~     responsible for gait and sleep cycle (pedunculopontine nucleus area, PPNa) should be tried.~      Therefore, a collaboration of multidisciplinary teams among the neurology movement disorder~     team and cognition and sleep team, and psychiatry team is essential, which has not been~     tried before in studying and treating the challenging gait difficulty in Parkinson patients.~   "
15284|NCT02857231|"~     Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to~     impedance parameters as measured by ImpediMed's BIS technology.~   "
15285|NCT02857218|"~     This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging~     (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer.~     Ferumoxytol is a form of very small iron particles that are taken up by cells in normal~     lymph nodes and may work better in imaging patients with esophageal cancer when paired with~     MRI.~   "
15286|NCT02857205|"~     Hirschsprung disease is a congenital abnormality due to the lack of migration of neural~     crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the~     absence of parasympathetic control of the distal bowel from the anal sphincter to various~     levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The~     incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the~     aganglionic segment.~      Regardless of the surgical complications, patients with Hirschsprung disease are exposed to~     the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is~     responsible to a major part of Hirschsprung disease morbimortality. Its onset is more~     frequent during the first two years of life and then decrease with age.~      Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that~     involves microbiota, intestinal barrier, immune system and enteric nervous system. This~     breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be~     responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the~     pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients~     limit any conclusion or clinical use.~      We hypothesize microbiota is a major factor in HAEC onset and in their functional bowel~     problems. Considering HAEC is more frequent the first two years, we think intestinal~     microbiota changes with time in those patients. This project is innovative because we will~     use high throughput sequencing methods and analysis for microbiome analysis on fecal samples~     from a multicenter cohort of patients at various ages.~      Multicentre transversal study.~      This study has the potential to significantly modify clinical practice for Hirschsprung~     disease patients: a better care for HAEC and functional troubles thanks to a better~     understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic~     treatment of patients at high risk of HAEC.~   "
15329|NCT02856633|"~     The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE~     Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti~     Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital~     signs and to detect the health conditions required by the competition.~   "
15287|NCT02857192|"~     Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The~     investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17~     response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there~     are to date no data concerning their precise phenotypic and functional characteristics and~     notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the~     investigator is that, in GCA, there is quantitative and above all functional deficit of~     Treg. Recently, progress has been made in the identification of Treg with new markers~     (CD39), which will make it possible to better identify and to study their specific~     functions. In this study the phenotypic and functional characteristics of Treg in GCA will~     be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted~     treatments for patients with GCA, notably via the blockage of cytokines that inhibit the~     differentiation and/or function of Treg.~      The study is classified interventional because a lot of blood samples are taken.~   "
15288|NCT02857179|"~     The aim of this cohort study is to collect prospectively clinical data on all the patients~     admitted in the investigators department for bariatric surgery or for any complication of a~     bariatric procedure. The investigators goal is not only to improve the follow-up but also to~     assess and publish the investigators results regarding weight loss and the complication~     rate.~   "
15289|NCT02857166|"~     The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity~     (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with~     advanced solid tumors.~   "
15290|NCT02857153|"~     This will be a multicentre, randomised, controlled and prospective clinical trial. All~     participants provided their written informed consent to participate in a randomized trial~     that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in~     elderly patients (65 or more years of age) during noncardiothoracic surgery under general~     anesthesia. The investigators hypothesise high-level blood presure of the intervention for~     reducing the incidence of post-operative complications.~   "
15291|NCT02857127|"~     A quasi experimental study evaluating the effectiveness of a walking program at primary~     health care settings in a low-income area~   "
15292|NCT02857114|"~     Measure the impact of touch relaxation on pain communicative patients suffering from chronic~     pain of cancer origin inpatient Oncology. measure over three days the effects on pain~     anxiety welfare and consumption of analgesics~   "
15293|NCT02857101|"~     The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of~     cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The~     determination of calprotectin in ascites, used for the diagnosis of infection of ascitic~     liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the~     determination of calprotectin in ascites was not evaluated properly. The investigators would~     thus evaluate the interest of the determination of calprotectin in ascites for the rapid~     diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their~     disease. The main purpose of this pilot study will determine the optimal threshold~     calprotectin in ascites for diagnosis of ISLA.~   "
15294|NCT02857088|"~     The study aimed to determine the emotional reactivity of depressed patients to visual and~     olfactory stimuli in comparison with healthy volunteers.~   "
15295|NCT02857075|"~     Every year, several millions of red cell concentrates are transfused. For each of them, a~     pretransfusional compatibility test is performed. In France, an ABO compatibility test at~     the patient's bedside is performed, but rhesus compatibility is not yet checked. However,~     rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.~      The objective of ABORDAGE project is to develop another biochip that specifically captures~     RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.~   "
15296|NCT02857062|"~     The investigation will evaluate, under dermatological control, the cutaneous in-use~     tolerance of E45 Eczema Repair Emollient with two or three times daily application, over a~     period of two weeks on children and babies with dry/atopic and very dry/atopic skin.~   "
15297|NCT02857049|"~     Malnutrition affects until 70% of the patients hospitalized in geriatric's units and~     constitutes an independent risk factor of morbidity and mortality. Malnutrition is also~     associated with increased length of stay and increased costs, and alters the quality of~     life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of~     malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional~     supply with a high density of calorie and protein. The clinical efficiency of ONS is well~     demonstrated whether on nutritional parameters or on clinical outcomes. However,~     acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only~     50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple:~     anorexia, taste changes, monotony … also partly because patients dislike flavor, taste or~     texture. The respect of patients' preferences is essential to improve the therapeutic~     observance to ONS. Generally, ONS are delivered after the patient has told his preferences~     orally to the dietitian. To date, there is no study evaluating the effect of an alternative~     strategy based on a preliminary degustation of several products on the effective consumption~     of ONS in geriatrics.~      The study is designed as prospective, randomized, controlled, open study to test this~     strategy in older undernourished people hospitalized in geriatrics who require prescription~     of ONS. This study will be performed among 220 older people hospitalized in two departments~     of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).~      The main objective is to compare the therapeutic observance to ONS when products are~     delivered to older people according to the usual way (preferences announced orally and/or~     dietitian's choice) or according to an alternative strategy based on a preliminary~     degustation of several products varying for flavor and texture but always in respect of the~     medical prescription. The secondary objective is to compare the evolution of the nutritional~     status estimated by routinely used clinical and biological parameters, as well as the main~     clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients~     will be reevaluated clinically 3 months after the hospital's discharge.~      The hypothesis is that a strategy based on a preliminary degustation, leading to an informed~     choice, will significantly improve the acceptability and the effective consumption of ONS~     during the hospital stay, and will also impact positively the nutritional status at~     hospital's discharge and 3 months after. The validation of this hypothesis could allow~     recommending the generalization of preliminary degustation of ONS at the time of their~     prescription to optimize the therapeutic observance in undernourished older people.~   "
15298|NCT02857036|"~     The study aims to characterize the rhythmic parameters of unipolar depressed patients that~     are associated with the response to antidepressants after 6 weeks of treatment.~   "
15330|NCT02856620|"~     The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in~     patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study)~     Part I: Observational study to characterize phenotypes, structural alterations and~     biomarkers profiles in a broad spectrum of patients with aortic stenosis and heart failure~     with preserved ejection fraction (HFpEF).~      Part II: Prospective cohort study to characterize patients' phenotypes, cardiac structural~     alterations, circulating biomarkers and frailty in order to optimize risk stratification and~     patient selection for aortic valve intervention.~   "
23312|NCT02752035|"~     The purpose of this study is to determine the efficacy superiority of ASP2215 and/or ASP2215~     plus azacitidine versus azacitidine as measured by overall survival (OS) and event-free~     survival.~   "
15299|NCT02857023|"~     Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD).~     These deficits can significantly disrupt otherwise normal trajectories toward academic and~     vocational achievement and negatively impact psychosocial outcomes. Despite widespread~     recognition of neurocognitive deficits, there are no treatments shown to maintain or recover~     functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been~     a standard intervention used to stabilize and recover functioning in individuals with~     accidental or disease-related brain injury. Recent advances in technology have led to the~     development of computerized CT programs. This study seeks to assess the feasibility and~     efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents~     with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a~     randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed).~     Feasibility will be assessed by examining participation, retention, and program completion~     rates, as well as feedback from a feasibility and acceptability questionnaire and a brief~     qualitative interview. Participants will also complete assessments of attention, working~     memory, and academic fluency at baseline and immediately following the intervention. A final~     assessment will be conducted 6 months after the conclusion of the intervention to evaluate~     the stability of treatment effects.~   "
15300|NCT02857010|"~     Double-blind placebo randomized controlled trial evaluating the clinical efficacy of~     allogenic bone marrow derived mesenchymal stem cells in cirrhotic patients with~     acute-on-chronic liver failure~   "
15301|NCT02856997|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE~     regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.~   "
15302|NCT02856984|"~     The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP)~     study is to assess the strength of the association between Zika virus infection (ZIKV)~     during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission.~     The study will prospectively enroll a cohort of pregnant women during the first trimester of~     pregnancy and follow them through their pregnancy to identify for clinical evidence of acute~     ZIKV, while controlling for potential confounders. Outcomes in the women, the developing~     fetus, and infants will be assessed. All protocol-specified data will be recorded and~     entered in a central data management system for the purposes of analysis of composite data~     from the study.~   "
15303|NCT02856971|"~     Between 2009 and January 2016, the investigators included 49 patients from four hospitals in~     Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee~     arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive~     cohort aims at studying the functional results after 2 years follow up.~   "
15304|NCT02856958|"~     The purpose of this study is to compare acute nerve decompression versus nonoperative~     treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We~     hypothesize that acute nerve decompression patients will have better long-term outcomes to~     patients treated non-operatively for peroneal nerve palsies after TKA.~   "
15305|NCT02856945|"~     At this time, there is no standardization for knee trauma care in children. Each physician~     is free to resort or not to radiography to verify or dispel bone fracture, depending on~     radiographic device availability. This decision is based on trauma severity, clinical~     features, and physician experience.~      Knee traumatisms are a common reason of consultation. In emergency departments, radiographic~     use is widespread for those traumatisms, but not in private practice.~      Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no~     details. Yet, radiography exposes bone fracture which may require a specific orthopaedic~     care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in~     order to identify severe knee traumatisms, requiring radiography to assess bone fracture.~      Those criteria should have a sensibility close to 1, and the highest specificity. Such~     criteria could significantly decrease the number of radiography thus irradiation,~     emergencies waiting time, and consultation expenses without missing bone fracture.~      Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated~     tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both~     immediately and in the emergency department. Presence of one of those criteria required~     front and profile radiography to assess bone fracture.~      However, few studies have been conducted among children, and they do not confirm the use of~     those criteria targeting fracture screening. Data are contradictory and they do not allow~     concluding that such criteria could be of benefit for children. Moreover, studies only~     consider adults clinical criteria. This study would be the first to implement specific~     paediatric criteria, which make this study original.~   "
15306|NCT02856932|"~     PICOTS:~      P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass~     Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance~     (Functional properties Biological properties) using (World Dental Federation) Fédération~     dentaire internationale (FDI) criteria for dental restorations.~      T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high~     caries risk patients with class I cavities will glass ionomer with glass hybrid technology~     has similar clinical performance as conventional high viscosity glass ionomer~   "
15307|NCT02856919|"~     This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent~     vascular facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.~   "
15308|NCT02856906|"~     The purpose of this study is to determine whether what kind of occlusion are related the~     orofacial pain under investigation, and whether occlusal adjustment have an effect in relief~     of this kind of orofacial pain.~   "
15309|NCT02856893|"~     The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as~     a new standard for testing tumor progression compared with conventional radiological~     procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M~     test during treatment the investigators will assess the predictive value of liquid biopsies.~     APPLE trial will examine the best strategy for delivering osimertinib (upfront versus~     sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally,~     the trial will also explore the mechanisms of acquired resistance to Osimertinib based on~     the results of an optional biopsy upon progression.~   "
16874|NCT02836470|"~     The purpose of this study is to establish preliminary evidence of the efficacy, safety, and~     tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal~     adhesions in subjects undergoing elective bowel resection.~   "
15311|NCT02856867|"~     This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II~     trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This~     study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with~     metastatic disease. Patients will have had no previous chemotherapy for metastatic~     esophagogastric cancer. Patients will receive nintedanib or placebo in combination with~     mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous~     infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85~     mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or~     placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long~     as they have not experienced any adverse events requiring permanent discontinuation of study~     medication and have not demonstrated disease progression.~      The primary objective is to test the hypothesis that progression free survival (PFS) is~     prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma~     when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus~     mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in~     the pooled arms.~   "
15312|NCT02856854|"~     EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone~     (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name~     Serax®; now marketed as oxazepam (generic) only).~      This Phase 1b cocaine interaction study is being conducted in order to assess the safety and~     PK of EMB-001 and cocaine in combination.~   "
15313|NCT02856841|"~     44 patients were enrolled in this study as they had malignant epithelial ovarian~     tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and~     compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum~     cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied~   "
15314|NCT02856828|"~     The purpose of this study is to evaluate the effectiveness of a novel digital image~     enhancement (DIE) technology in reducing the radiation exposure to both the patient and~     surgical staff during standard intramedullary nail placement for treatment of hip fractures.~     Secondarily, to evaluate whether the image quality and reproducibility of desired images can~     be improved with use of the DIE technology. Finally, to evaluate whether DIE technology~     reduces total operative time.~   "
15315|NCT02856815|"~     To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the~     patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular~     carcinoma~   "
15316|NCT02856802|"~     A safety and efficacy of DFN-02, being conducted at multiple centers in the United States.~   "
15317|NCT02856789|"~     The purpose of the study is to give the proof of concept of the Fibrin structure assay on~     STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from~     the normal population. Secondary objectives are to determine the precision of the assay, to~     record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation~     activation assay and in a coagulation-lysis assay.~   "
15318|NCT02856776|"~     There continues to be debate as to how much vitamin D an adult requires to be vitamin D~     sufficient. A multitude of association studies have suggested that improving serum 25(OH)D~     >30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of~     this study is to define dynamic changes in PTH, broad gene expression in circulating immune~     cells, metabolomics, and microbiome profile in response to varying doses of vitamin D~     supplementation.~   "
15319|NCT02856763|"~     To identify predictive factors of adalimumab (anti TNF) response in patients with luminal~     Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete~     resolution of infection.~   "
15320|NCT02856750|"~     A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for~     Adjutant Pain Control Following Acute Rib Fractures.~   "
15321|NCT02856737|"~     Delirium is an acute disturbance in mental abilities and confusion that affects many patient~     in the hospital and is caused by multiple factors including and altered sleep/wake cycles~     and multiple sedating medications. Patients in the ICU are particularly susceptible to~     developing delirium due to increased noise levels and metabolic derangements.~      Numerous studies have shown that delirium can be associated with many negative outcomes,~     including longer hospital length of stay, increased time on a ventilator, higher mortality~     rates, and greater long-term cognitive dysfunction. There are a series of~     non-pharmacological interventions that have been shown to reduce delirium especially in~     intensive care units. These include noise reduction, frequent reorientation, reducing~     unnecessary stimulation at night, and grouping patient care procedures.~      The aim of this study is to evaluate the benefits of eye masks and earplugs (used~     concurrently) on reducing delirium and to assess for associated outcomes such as length of~     stay, use of sedating medications, morbidity, and mortality. The benefits of this are to~     improve sleep quality, and this intervention has been associated with a reduction in the~     risk of delirium.~   "
15322|NCT02856724|"~     This study evaluates the effectiveness and safety of early amniotomy after vaginal~     prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early~     active phase of labor for early amniotomy group ( half of participants) when the cervix will~     dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other~     half of participants) until the membranes rupture spontaneously.~   "
15323|NCT02856711|"~     The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an~     enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new~     parents prepare for parenting and respond to common stressors.~   "
15324|NCT02856698|"~     Acute pulmonary edema (APE) is a common condition in the emergency room, associated with~     considerable mortality. The use of intravenous morphine in the treatment of APE remains~     controversial and Benzodiazepines have been suggested as an alternative for morphine to~     relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in~     APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to~     evaluate the efficacy and safety of morphine in patients with APE.~   "
15325|NCT02856685|"~     This is a Phase 1/2, open-label, multicenter study.~   "
16966|NCT02835274|"~     The primary objective is to characterize the programming effects of Boston Scientific~     Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of~     Parkinson's disease in acute and chronic settings.~   "
15331|NCT02856607|"~     Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner~     surface of the heart), which may include one or more heart valves. Epidemiologic pattern has~     changed during the last 20 years whereas the incidence was unchanged. However, the mortality~     increase despite recent diagnosis and therapeutic advances.~      Only few investigations consider the prognostic and the therapeutic medical care according~     to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom~     diagnosis and medical care are realized in a referent center with cardiac surgery, (ii)~     patients secondary addressed to a referent center with cardiac surgery, (iii) patients for~     which the totality medical care are performed in non-referent health center. In addition,~     epidemiologic studies concern only a part of IE, not including most of the time the patients~     hospitalized in non-referent center.~      The aim of the study was to determine the prognosis of threated patients according to the~     clinical care pathway. Secondary objectives was (i) to evaluate the application of European~     recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and~     surgical practice, (ii) to compare the epidemiologic profile according to the type of~     center.~      For this, 300 patients addressed in the 22 French participating centers for a possible or~     certain IE according to Duke Criteria were prospectively included during 3 years.~      Patient data (clinical, demographical, biological, microbiological, echocardiographic and~     evolutive data) were collected at the admission, during hospitalization, at discharge and~     one-year follow up.~   "
15332|NCT02856594|"~     This study aims to determine whether, compared with placebo, the nighttime administration of~     a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative~     delirium in extubated post-cardiac surgical patients.~   "
15333|NCT02856581|"~     This randomized phase III trial studies how well smoking cessation intervention works in~     reducing surgical complications in patients with newly diagnosed lung cancer who smoke~     cigarettes. This study will use two smoking cessation interventions: Varenicline (a drug~     that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine)~     with behavioral interventions (consisting of a brief clinician-delivered intervention and~     tobacco quitline [tobacco cessation service available through a toll-free telephone number]~     follow-up) with placebo (a pill with no active medication) along with the same behavioral~     interventions. It is not yet known whether smoking cessation intervention prior to surgery~     is effective in reducing surgical complications for these patients.~   "
15334|NCT02856568|"~     This phase Ib trial studies the side effects and best dose of ricolinostat when given~     together with gemcitabine hydrochloride and cisplatin in treating patients with~     cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the~     body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     ricolinostat together with gemcitabine hydrochloride and cisplatin may work better in~     treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to~     other places.~   "
15335|NCT02856555|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in~     adults with nonalcoholic steatohepatitis (NASH).~   "
15336|NCT02856542|"~     This study aims to describe the patient population being treated and evaluate their~     treatment adherence and treatment outcomes during treatment of scalp psoriasis with~     Daivobet® gel Applicator for 4 weeks.~   "
15337|NCT02856529|"~     Considering the importance of infection control practices, Madinah Public Health Department~     launched a new license program for healthcare workers, the Basic Infection Control Skills~     License program (BICSL). BICSL has been launched to train healthcare workers all over the~     region in a scientific standardized way.~      To assess BICSL effectiveness, a non-randomized control study will be conducted in two of~     the general hospitals in Madinah. An electronic bilingual self-administrated valid and~     reliable questionnaire will be used to evaluate the workers knowledge and practices before~     and after three and six months of the intervention. The knowledge and practice answers were~     scored and the scores were categorized to facilitate the comparison. A BICSL certified~     trainer will be conducting the intervention, a one to one training session. A SPSS program~     will be used to analyze the data. Administrative and ethical approval was obtained from~     Madinah health authority. The participants will complete an electronic consent before they~     fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not~     will be insured to all participants. This study will assess the license effectiveness in~     improve knowledge and compliance.~   "
15338|NCT02856516|"~     This will be a randomized, cross-over design. Subjects will be randomized to one of three~     interventions on three separate study days, 1 week apart.~   "
15339|NCT02856503|"~     High-doses of Vitamin D (VD) may be used as targeted therapy against breast cancer. The~     investigators will assess the effect of high dose VD on the following biomarkers in the~     breast cancer cells: VDR, estrogen receptor (ER), progesterone receptor (PR), epidermal~     growth factor receptor 2 (Her2/neu), androgen receptor (AR), as well as epidermal growth~     factor receptor 1 (EGFR) and Ki-67, as markers of proliferation, and E-cadherin, a marker of~     invasion and metastasis.~   "
15340|NCT02856477|"~     The study aims to assess the therapeutic benefits of the adaptation of the antidepressant~     dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.~      Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the~     action time and the after effects.~   "
15341|NCT02856464|"~     The trial will be conducted as a multicentre open label, randomised prospective phase II~     clinical trial in patients with high risk myeloid malignancies.~      The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI)~     delivered as part of a planned schedule improves the disease free survival of patients with~     myeloid malignancies.~   "
15342|NCT02856451|"~     A case series analysis of encephalitis events reported to the Sponsor for patients treated~     with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.~   "
15343|NCT02856438|"~     The objective of this expanded access program is to provide treatment with elotuzumab in~     combination with lenalidomide and dexamethasone for patients with relapsed or refractory~     multiple myeloma at Japanese sites where licensed physicians determine clinical need.~   "
15344|NCT02856425|"~     Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid~     tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the~     combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and~     clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy~     for the benefit of the patients.~   "
15345|NCT02856412|"~     There is evidence demonstrating that aerobic exercise improves many symptoms of~     Posttraumatic Stress Disorder (PTSD) including; anxiety, depression, insomnia, and~     cognition. With the goal of using exercise as a rehabilitation therapy for Veterans with~     PTSD, a team of scientists and doctors developed a 12-week exercise program, combining~     aerobic and strength training with concentration training and mindful breathing techniques.~     The initial pilot study suggested that Integrative Exercise may improve overall quality of~     life, sleep quality, cardiovascular fitness, and PTSD symptoms. This new study will help~     determine the effectiveness of Integrative Exercise compared to health education classes.~     The overall goal is to determine if integrative exercise is an effective rehabilitation~     intervention for combat Veterans with PTSD.~   "
15346|NCT02856399|"~     The methadone is an useful opioid for the cancer pain treatment, mostly used in second or~     last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians~     agree that the methadone could have an effect in neuropathic cancer pain. During a previous~     study the investigators find that the pain was still improving after the week 2, but they~     had only a small number of patients still included at this stage and they cannot conclude.~      The investigators decide to follow up systematically all the patients undergoing a methadone~     treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain~     improvement.~   "
15347|NCT02856386|"~     Micronutrients missing in the diet may assist in supporting digestive health in children~     with chronic GI issues. This study will monitor changes in symptoms associated with~     digestive problems in children provided with a dietary supplement that will be taken in~     conjunction with the standard of care.~   "
15348|NCT02856373|"~     Rationale:~      Sympathetic activity plays an important role in the pathogenesis of ventricular~     tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on~     individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation~     (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce~     local and whole-body sympathetic activity. The investigators hypothesize that percutaneous~     transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries~     will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in~     patients with sympathetic ventricular arrhythmias.~      Objective:~      This study will investigate the effects of renal nerve stimulation before and after~     percutaneous transluminal RDN on cardiac excitable properties including induction of~     ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with~     catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and~     arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular~     arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM)~     and ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the~     anti-arrhythmic effects of RDN in patients with sympathetic ventricular tachy-arrhythmias.~      Study design:~      Investigator initiated, multi centre, six pretest-posttest design studies.~      Study population:~      Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal~     pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT~     syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-65~     year.~      Intervention:~      RDN will be performed according to routine clinical practice. Prior to the ablation~     procedure, catheter mapping of the renal arteries will be performed according to routine~     clinical practice. Clinical and biological responses to transluminal electrical renal nerve~     stimulation will be assessed before and after RDN.~      Study endpoints:~        -  Main procedural study endpoint: Induction of ventricular arrhythmias in response to~          renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced~          ventricular arrhythmias after RDN.~        -  Main clinical study endpoint: Development of ventricular arrhythmia during exercise~          stress testing performed 6 months after procedure.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      In several studies, it was shown that RDN was safe. The intervention resulted in~     significantly better control of blood pressure with less medication, and beneficial changes~     in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a~     higher success of atrial fibrillation prevention. In case reports and case series, RDN had a~     favourable effect in patients with sympathetic drug refractory ventricular~     tachy-arrhythmias.~   "
15349|NCT02856360|"~     The objective of this proposal is to determine the effects of footwear stiffness on a large~     cohort of high school football players during a football season. The investigators expect~     that functional athlete groups will be developed, based on subject specific assessments~     (biomechanical, morphological, performance, comfort), and lead to important translational~     findings that may impact footwear modification and recommendation to a population of~     American football players. Two standard cleats will be randomized and provided during a~     season of high school football. Ratings of comfort, performance, and injury will be~     collected throughout the season.~   "
15350|NCT02856347|"~     The aim of the study is to study a radiating diagnosis agent used in post surgery when the~     biological assessment highlighted a residual disease.~      This is an inter-regional multicentric, prospective study evaluating the benefit of PET~     F-DOPA imaging in involved node detection compared to standard imaging assessment of~     medullar thyroid cancer.~      The purpose of the study is to evaluate the impact and performance of a new PET / CT~     (computerized tomography ) tracer targeting dopamine receptor to detect a residual~     ganglionar biological disease after initial surgery in Medullar thyroid cancer without~     morphological detectable target compared to standard imaging~      Obtained data will be compared to a gold standard based on cytology performed on :~        -  nodes when they could be removed~        -  histology when a new surgery will be recommended~        -  surveillance when the 2 first cases will be not applicable (imaging monitoring,~          evolution of thyrocalcitonin)~   "
15351|NCT02856334|"~     The purpose of this study is to determine if the psychosocial factors in women with chronic~     pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors~     with central sensitization and dysfunctional pain.~   "
15360|NCT02856217|"~     Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the~     vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced~     pelvic organ prolapse and serves as the criterion standard against which other operations~     are compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral~     anterior longitudinal ligament reinforced with a graft, usually synthetic mesh. More than~     225.000 surgeries are performed annually in the United States for pelvic organ prolapse.~     Abdominal sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but~     little is known about safety and long-term effectiveness.~      Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on~     lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with~     laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for~     pelvic organ prolapse.~   "
15361|NCT02856204|"~     This research trial studies the shotgun sequencing of blood samples in diagnosing febrile~     neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients~     with acute myeloid leukemia in the laboratory may help identify pathogens and accurately~     diagnose infections such as febrile neutropenia.~   "
15352|NCT02856321|"~     A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL)~     muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into~     this muscle have not yet been described in the literature. Based on the results of a~     previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target~     for botulinum toxin injections in the early management of spastic equinus in children aged 2~     years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.~      The aim of this retrospective study is to describe in intramuscular BoNT (Dysport)~     injections into PL based on the results obtained in a cohort of children (approximately 30~     subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the~     service since 2007 until July 2012.~      The investigators results are based on clinical, radiological and video evaluations. For~     this study, data will be collected in medical folder of each children belonging to this~     cohort.~      All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which~     have been treated by BoNT (Dysport) intramuscular injections into PL in the service between~     2007 and July 2012 will be screened. Subjects will be selected according to the following~     defined inclusion and exclusion criteria.~      Data will be collected retrospectively (using a specific case report form designed for the~     study) in medical folder of each included subject for all visit of follow-up after BoNT~     (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then,~     data will be entered in a database. After that, they will be analysed .~   "
15353|NCT02856308|"~     This is a prospective, single-arm, multi-center, international, open-label, non-randomized,~     clinical study.~      The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair~     implant device in subjects affected with hair loss.~   "
15354|NCT02856295|"~     The aim of this study is to compare between anti-10a levels in postpartum women receiving~     different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's~     weight and the second group receiving 1mg/kg to a maximum dose of 120 mg~   "
15355|NCT02856282|"~     The purpose is to obtain real-world information on how consumers are complying with the~     product labelling This study will coincide with the launch of Pirinase Hayfever Relief for~     Adults 0.05% Nasal Spray in the United Kingdom (UK).~   "
15356|NCT02856269|"~     The purpose of this pilot study is to determine whether zinc supplementation significantly~     affects immune activation in HIV-infected subjects.~   "
15357|NCT02856256|"~     The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to~     the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's~     blood. The choroidal thickness fluctuates according to the state of fullness of its~     constitutive vessels. The choroid and the neuroretina (separate by the pigmentary~     epithelium) are intimately linked and are subject to modifications during the ingestion of~     caffeine and taurine combined. Several authors have shown a significant decrease of the~     choroidal thickness lasting at least 4 hours after the ingestion of a small coffee. This~     decrease may be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant~     amino acid in the retina. Recent studies have shown the importance of this amino acid in the~     physiology of both, retinal pigmentary epithelium and retinal ganglion cells.~      RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the~     equivalent of a coffee mug) and 1 g of taurine.~      This pilot trial aims to study the variations of the choroidal thickness and to describe~     possible modifications within the pigmentary epithelium, due to the ingestion of caffeine~     and taurine. The results of this study will act as a reference for an ulterior trial aiming~     specific choroidal pathologies of young patients, such as the central serous~     chorioretinitis.~   "
15358|NCT02856243|"~     Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted~     organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia~     vasculitides are associated with significant morbidity and mortality, and require~     therapeutic intervention. With the discovery of hepatitis C virus (HCV) as the etiologic~     agent for most cases of mixed cryoglobulinemia new opportunities and problems for crafting~     therapy of HCV mixed cryoglobulinemia (MC) have emerged. A new and major concern was the~     potential adverse effects that immunosuppressive therapy with glucocorticoids and cytotoxic~     drugs could have on an underlying chronic viral infection. Alternatively the discovery of~     HCV provided the opportunity to control HCV-MC with antiviral therapy based on the belief~     that the underlying infection was driving immune complex formation and resultant vasculitis.~     Inducing a sustained virologic and clinical response and minimizing the use of~     immunosuppressive drugs are the main goals in the treatment of patients with HCV-MC~     vasculitis. Aggressive antiviral therapy has been shown to induce a complete remission of~     HCV-MC in up to 70% of patients. New antiviral combination, Interferon (IFN)-free regimens~     have recently proved very high virological response rate and with a very good safety profile~     and now need to be evaluated in severe and/or refractory HCV-MC patient's population.~   "
15359|NCT02856230|"~     Endovascular treatment of below the knee disease is a well-established therapy to improve~     outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated~     the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel~     disease. A successful recanalization of foot artery was related to a higher ulcer healing~     and a reduction of major amputation. Moreover absence of revascularization in a patient with~     critical limb ischemia is an independent risk factor for mortality. Despite the introduction~     of new devices dedicated to below the knee vessel disease treatment, with the development of~     guides and conical balloons, long term patency outcomes are still poor. Restenosis was~     observed in more than two thirds of patients within 3 months after angioplasty of tibial~     arteries with a high target lesions revascularization. These re-interventions are~     characterized by a higher morbidity and mortality due to several comorbidities associated to~     these patients. These data confirm the need to obtain more lasting results in order to~     improve long-term outcomes of these patients.~      Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after~     angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty~     have shown controversial results.~      The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL~     paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb~     ischemia.~   "
23353|NCT02751489|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
15362|NCT02856191|"~     The aim of this pilot study is to determine, as exhaustively as possible thanks to the~     continuous and precise recording of heart rhythm, the frequency of de novo atrial~     fibrillation in septic shock, which is currently unknown, and to identify specific factors~     that could be associated with the condition. These will be investigated more precisely in a~     future study. This constitutes the first step in a reflection on the management of Cardiac~     Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as~     a major prognostic factor for morbimortality, but for which management is uncertain in the~     absence of reference data.~   "
15363|NCT02856178|"~     This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML~     patients.~   "
15364|NCT02856165|"~     Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to~     provide respiratory support in children with moderate to severe bronchiolitis.~      However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN~     is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of~     acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently~     the need of PICU transfer.~   "
15365|NCT02856152|"~     This open-label, randomized, 4-way crossover study in healthy participants will determine~     the relative bioavailability of the tablet formulation relative to the capsule formulation~     and the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet~     formulation.~   "
15366|NCT02856139|"~     PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using~     ultra-widefield fluorescein angiography (UWFA).~      DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with~     best corrected visual acuity ≥ 20/20, refractive error < 3.00D, and without visible retinal~     pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was~     detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to~     the scleral spur was measured by ultrasound biomicroscopy.~   "
15367|NCT02856126|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial~     infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in~     patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).~   "
15368|NCT02856113|"~     This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD)~     compared to placebo when administered as monotherapy, or when added onto a background of~     metformin alone, insulin alone, or a combination of metformin and insulin in pediatric~     participants 10 to 17 years of age with type 2 diabetes mellitus (T2DM).~   "
15369|NCT02856100|"~     We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant~     PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging~     therapies for a spectrum of patients suffering from PCa. In this study we will image~     patients with CRPC undergoing second-line anti-androgen therapy (enzalutamide or~     abiraterone) using 18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring,~     with correlation to standard-of-care conventional imaging modalities (CIM) (CT, bone scan)~     and clinical follow-up.~   "
15370|NCT02856087|"~     High-dose remifentanil infused intraoperative ironically results in postoperative~     hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced~     hyperalgesia in animal model. In this clinical trial in patients undergoing general~     anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on~     remifentanil-induced hyperalgesia~   "
15371|NCT02856074|"~     The current management of ischemic stroke is based on different strategies that may be~     combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a~     telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal,~     it seems necessary to evaluate practices in local care in the field and the impact of these~     on the prognosis of ischemic stroke victims. The aim of this observational study is to~     compare these different care practices without interfering with the choice of strategy.~      A blood sample will also be taken at different times to study the value of growth~     differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as~     prognostic biomarkers~   "
15372|NCT02856061|"~     This pilot study examines concurrent and predictive relationships between eye tracking and~     clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye~     tracking will be comprised of both laboratory-based measures (using a commercial~     eye-tracking system) as well as home-based measures (using tablet-based eye tracking~     systems). The major goals of this study are both to improve our understanding of the~     potential role of eye tracking in clinical trials and to advance technologies that may~     further improve the sensitivity, robustness, accessibility, and ultimate utility of eye~     tracking methodologies.~   "
15373|NCT02856048|"~     The purpose of this study is to determine the efficacy of a temporary ovarian suppression~     obtained by administration of a gonadotropin releasing hormone agonist during alkylating~     agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH)~     serum levels in adolescents and young women with cancer.~   "
15374|NCT02856035|"~     Stroke (795,000/year in the US and 30 million existing stroke survivors in the world)~     damages brain neural structures that control coordinated upper limb movement. To most~     effectively target the brain damage, interventions should be directed so as to restore brain~     control serving coordination of peripheral neuromuscular function. Currently, there is a~     lack of a transformative intervention strategy, and only limited efficacy is seen in~     response to neural rehabilitation that is only peripherally-directed (limbs e.g.) or only~     directed at the brain. This study will employ a novel neural feedback approach with a~     closed-loop, real-time paradigm to engage and retrain existing brain function after stroke.~     Real-time functional magnetic resonance imaging (rtfMIR) provides neural feedback with the~     advantage of precisely identifying the location of brain activity for multiple cognitive and~     emotional tasks. However, the rtfMRI is costly and precludes motor learning that requires~     sitting and engaging the upper limb in complex motor tasks during imaging acquisition. In~     contrast, real-time functional near-infrared spectroscopy (rtfNIRS), although not as~     spatially precise as rtfMRI, offers a low-cost, portable solution to provide brain neural~     feedback during motor learning. This proposal will utilize both technologies in a hybrid,~     sequential motor learning protocol. Moreover, the study protocol will also simultaneously~     involve both central effective signals (through neural feedback) and peripheral affective~     signals by employing neutrally-triggered functional electrical stimulation (FES)-assisted~     coordination practice, which produces peripherally-induced affective signals from muscle and~     joint receptors. This novel combination intervention protocol will engage the central~     nervous system, motor effective pathway training along with induction of affective signal~     production (FES-assisted practice), all of which will be implemented within the framework of~     evidence-based motor learning principles.~   "
15375|NCT02856022|"~     The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation~     (EINS) is more effective than intravesical irrigation (II) in treating bladder pain~     syndrome.~   "
15376|NCT02856009|"~     Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of~     aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis.~     Patients older than 75 years also show excess mortality. One of the hypotheses to explain~     this situation is the high level of frailty in this population. Many tools to measure the~     concept of frailty have been developed. One important dimension of these tools is the~     nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent~     situation, is also a complex phenomenon.~      The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as~     a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in~     subjects older than 75 years hospitalized in Dijon CHU.~   "
15377|NCT02855996|"~     The Child and Family Research Partnership (CFRP) will be conducting the local evaluation~     of AVANCE's Fathers in Action/Padres Activos (FA/PA) fatherhood program. AVANCE is a~     non-profit organization that has served low-income families and children since its founding~     in 1973. AVANCE sites have been providing fatherhood services for some time, but the~     programming offered has varied across sites and no rigorous evaluation of the programs has~     been completed. Through a federally-funded Responsible Fatherhood grant, AVANCE aims to~     create one fatherhood curriculum to be used across their sites: Fathers in Action/Padres~     Activos (FA/PA).~      The purpose of the study is to advance the field of knowledge in the area of fatherhood~     programing by providing rigorous evidence on the impact of a comprehensive fatherhood~     program on enhancing a father's ability to be involved with and parent his child, in~     addition to providing more information on the selective characteristics of fathers who~     choose to participate in fatherhood programs. The study will seek to answer the following~     research questions: (1) What are the demographic and relationship characteristics of fathers~     who choose to participate in the Fathers in Action/Padres Actívos (FA/PA) program, and how~     do these characteristics compare to the fathers associated with mothers and children in~     other AVANCE programs?; (2) Does the FA/PA program positively impact parenting and~     co-parenting, father engagement and involvement, and healthy relationship?; (3) Are the~     program impacts similar for low-income fathers across regions (Houston v. the Rio Grande~     Valley), race/ethnicity (African American v. Hispanic), and coresidential status~     (nonresident v. resident)?; and (4) What are the factors that enhance or impede the~     successful implementation of the FA/PA program?~   "
15378|NCT02855983|"~     The specific aim of this study is to determine whether perforating fat injections to the~     plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia~     thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic~     fat properties of adipose stem cells (ie. growth factors) to the improvement in pain,~     quality of life, and plantar fascia thickness over time.~   "
15379|NCT02855970|"~     The aim of this work is to develop and validate a scale adapted to French cultural~     characteristics. It will be based on the SS-QoL scale and be simple and quick to use in~     everyday practice. It is not simply a translation. This transcultural adaptation requires~     linguistic and psychometric validation, by studying its validity, its reliability and its~     sensitivity to change, as though it were a new instrument. The investigators will then~     develop a short version by reducing the items and conduct a psychometric validation.~      The translation and validation of a short French version of the SS-QoL scale will generate a~     reliable and sensitive, easy-to-use tool suitable for use in everyday practice.~      The final objective is to use this tool as a principal judgement criterion in future~     therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic~     factors that affect quality of life so as to provide better management of this disease.~   "
15380|NCT02855957|"~     Our project aims to assess and validate an innovative prognostic and diagnostic test in~     order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for~     a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia~     and iii) follow the evolution of this pool in response to treatment of patients. In the~     future, this prognostic test based on the measurement of free α-Hb pool may be suitable for~     routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients~     and a group of 50 healthy volunteers have been recruited.~   "
15381|NCT02855944|"~     The purpose of this study is to determine how patients with ovarian, fallopian tube, and~     primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.~   "
15382|NCT02855931|"~     Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of~     chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The~     goal of surgery is now to widely marsupialize the sinus cavities in order to optimize~     topical steroid irrigation treatment in the postoperative period. With that being said, the~     true extent of surgery needed for optimal patient outcome has yet to be elucidated. More~     specifically, in the last 30 years, people have argued about the best way to manage the~     middle turbinate. Some state that it should be preserved at all times to protect the sinus~     cavities from inhaled irritants and allergens and keep this surgical landmark untouched for~     future surgeries. On the other hand, there are defenders of routine resection of this~     turbinate, whether it is affected by polypoid changes or not. Many studies have looked at~     the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis,~     anosmia, or atrophic rhinitis but the more recent literature does not show such significant~     associations. A recent topic of debate is whether partial removal of the anterior and~     inferior portion of the middle turbinate affects nasal polyps recurrence or improves~     long-term outcomes by further facilitation of post-operative topical therapies. Some~     retrospective data has shown that its resection could prolong the time before the need for~     revision surgery and improve both endoscopic and olfaction scores. A few prospective studies~     have also been published but unfortunately none of these were randomized, thus introducing a~     significant selection bias. Thus, there is a need for a formal randomized, controlled trial~     to elucidate this question.~   "
15390|NCT02855827|"~     Ovarian cryopreservation is one of the available option for preserving fertility prior to~     potentially sterilizing treatments. In the absence of other techniques such as in vitro~     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used~     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was~     obtained by Roux et al. in 2009.~      This clinical trial aims to build a cohort of patients likely to use their ovarian tissue~     cryopreserved by autograft.~   "
15383|NCT02855918|"~     Suicidal behavior (SB) is a major public health problem in France, with more than 10,000~     suicides and 220,000 suicide attempts per year.~      According to the commonly accepted model for understanding suicidal behavior, individuals~     who carry a suicidal act when subjected to stress factors (environmental stress, depression,~     substance ...) are those which have a specific vulnerability.~      These vulnerabilities can be considered as clinical parameters (propensity to despair,~     aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the~     serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...).~     Suicidal vulnerability is partly underpinned by genetic factors. The interest of current~     researches is to identify biomarkers that will improve the opportunities for early~     identification of subject with a risk for SB. Numerous scientific studies, including~     post-mortem studies of the brains of suicide completers, have established a link between~     dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic~     activity of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and~     suicidal behavior. A prospective study is needed to quantify and qualify in the blood of~     depressed patients (with or without a history of suicide) and healthy controls, the editing~     changes and the expression and alteration of the activity of ADARS.~   "
15384|NCT02855905|"~     A cold season involves higher cardiovascular morbidity and mortality. Several epidemiologic~     studies have implicated that persons with a cardiac disease, such as coronary artery disease~     (CAD) may be at higher risk for these adverse health events, but the mechanisms are not well~     established. Because both exercise and cold exposure stimulates cardiac and circulatory~     functions it is important to study their interaction especially among people with CAD and~     whose myocardial oxygen supply and function are weakened. The study examines how recommended~     health-enhancing upper and lower body exercise and warm-up in combination with cold exposure~     affects cardiovascular functions of people with CAD.~      The research includes randomized controlled experiments where the participants are 35-75~     year old men with CAD (CCS I-II) and recruited from the Oulu University Hospital. Each~     participant undergoes four different trials in random order where the temperature (+22°C or~     -15°C) and the form of exercise (brisk walking at 5.5 km/h or upper body exercise at 30 W),~     and warm-up regime is varied. The used exercise, clothing and exposure resemble an ordinary~     wintertime exercise event. Novel techniques are used to broadly assess cardiovascular~     function before, during and in the recovery phase.~      The obtained information is synthesized and translated to tailored year-round exercise~     instructions for people with CAD by the research team including experts from sports~     sciences, physiology, public and occupational health, clinical sciences and with~     complementary knowledge in physical activity, effective interventions and cardiovascular~     function. The study has broad national and international impact on the relatively passive~     aging population having CAD and residing and working in a cold climate. The produced~     information enables finding means to activate persons with CAD and where appropriate and~     safe year-round exercise may reduce or prevent adverse health effects. Health care personnel~     will have an improved possibility to prescribe physical activity programs for their clients~     and enabling better instructions of healthy and safe exercise as a way to promote health.~   "
15385|NCT02855892|"~     This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel~     design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001~     in patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group~     out of the three study groups and a placebo group after four weeks of placebo run-in period.~     Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment~     of benign prostatic hyperplasia, and a placebo is administered intradermally twice with~     two-week interval during this period. After that, the randomized subjects receive a study~     drug and a placebo intradermally seven times with two-week interval by visiting at Week 0,~     2, 4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week~     13 and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is~     evaluated over the 16-week period.~   "
15386|NCT02855879|"~     The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose~     metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients~     about to undergo coronary artery bypass grafting (CABG).~      In addition, the effect of these anomalies on post CABG morbi/mortality in the short term~     will be evaluated.~   "
15387|NCT02855866|"~     The scientific interest of this study is to improve post-operative comfort in patients after~     thyroid surgery using simple, inexpensive techniques. The investigator expects that local~     applications of ice or cortisone aerosols will reduce swallowing discomfort and control~     post-operative pain (POP). The investigator hopes that local cryotherapy will decrease~     post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the~     serous fluid at the site of the thyroidectomy).~   "
15388|NCT02855853|"~     Even though cognitive-motor performances are impaired in frail elderly subjects compared~     with healthy elderly subjects, exercising cognitive-motor processes in an implicit manner~     can improve the carrying out of real actions in everyday life.~      No training programme using virtual reality and serious games oriented towards the~     perception/action system has been tested in frail elderly subjects.~      The expected results are:~        -  In the short term, greater strengthening of motor and cognitive abilities in subjects~          trained with the virtual reality and serious games, thanks to stimulation through~          action and through the underlying processes.~        -  In the long term (+1 and +3 months at the end of the training period) better~          preservation of motor and cognitive abilities in subjects who took part in the virtual~          reality and serious games programme.~   "
15389|NCT02855840|"~     Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)~     are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for~     100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases~     and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM~     on the everyday life of patients are heavy, and notably linked to skin involvement, to~     diminished functional capacities and psychological problems. The vast majority of these~     diseases concern middle-aged, professionally-active individuals, for whom the~     socio-professional repercussions are major and too often neglected. The aim of this study is~     to analyse the consequences of auto-immune diseases on quality of life. Current quality of~     life questionnaires are not suitable, and do not reveal the reality of the situation and its~     different nuances. In this research, the quality of life of patients will be envisaged~     through their everyday lives. How do these patients construct the social reality of the~     disease? How do they perceive their health status and their social situation? How do they~     organize their everyday lives around the disease: work, leisure, relationships with their~     entourage... ?~   "
15530|NCT02854007|"~     A multicenter, prospective, observational cohort study with clinical, quality of life, and~     economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients~     with ischemic heart disease revascularized with Absorb in standard clinical practice in~     Spain. A before-after comparative analysis will be performed, so that each patient will act~     as his/her own control.~   "
15391|NCT02855814|"~     The American Academy of Pediatrics has recommended that growth in size (weight, length, and~     head circumference) and in body composition (fat and lean mass) in preterm infants should~     adhere as close as possible to the growth and body composition of a healthy infant in utero~     at the same gestational age. However, there are no body composition reference curves~     available at this time for the preterm infant population. The purpose of this study is to~     collect cross-sectional body composition data using air displacement plethysmography (PEA~     POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm~     infants within 3 days of birth, for the purpose of generating means, standard deviations,~     and percentile values for total body fat mass, total fat free mass, and percent body fat for~     infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth~     retardation will be selected for form the reference sample. The goal is to generate a set of~     common reference curves to be used in clinical centers against which to compare body~     composition status for individual infants.~   "
15392|NCT02855801|"~     The main objective of this project is to study, in patients with rheumatoid arthritis, the~     effects of an intermittent type exercise associated with cryotherapy on the level of~     inflammation during its recovery.~   "
15393|NCT02855788|"~     phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin,~     Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer~   "
15394|NCT02855775|"~     This Study evaluates covariables being able to potentially influence the elimination of the~     monoclonal antibodies (trastuzumab, bevacizumab and denosumab).~   "
15395|NCT02855762|"~     The gut microbiome is a new target to improve burden of disease measures in mood disorders,~     yet novel interventions to affect the gut microbial complement and improve psychiatric~     outcomes have not been developed. Animal studies show causative influence of the gut~     microbiome on developmental trajectories of central neurochemical systems to effect~     anxiety-like and depressive-like behaviors. Preliminary studies in humans show psychiatric~     benefit of pre- and pro-biotic supplementation in depressed individuals. However, it has not~     been determined which gut microbes are beneficial or detrimental to human mental illness and~     how to specifically target them for therapeutic benefit. Our long-term goal is to determine~     effective methods to target the human gut microbiome to improve mental health treatment~     outcomes. The objective of this study is to determine how specific dietary control alters~     the microbiome composition to effect clinical outcome measures in a longitudinal study of~     individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) /~     high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific~     butyrate producing members of the Firmicutes phylum in the gut microbiome, which will~     attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients.~     The rationale for the proposed research is to take the first step in a continuum of studies~     to develop personalized novel approaches to treat mood disorders, including the need to~     address gut dysbiosis, which often co-occurs with mental illness. The investigators will~     test our hypothesis and achieve the objective of this proposal with the following Specific~     Aims: 1) Determine the taxonomical change in the stool microbiome following a low CHO / high~     PUFA diet; and 2) Determine the changes in sleep quality, anxiety, and depression following~     a low CHO / high PUFA diet. These aims will be achieved using the unique resources at the~     University of Michigan, including the Nutrition Assessment Laboratory for dietary~     intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter~     Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators~     expect to set the stage for future studies to assess neurochemical mechanisms. These data~     will provide a greater understanding of the mechanism by which diet controls the specific~     microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve~     response to psychiatric treatment paradigms.~   "
15396|NCT02855749|"~     Use of the ultrasound before, during and after percutaneous tracheostomy allows us great~     advantages; anatomy of the pre and paratracheal region and displaying potential aberrant~     vessels, and so the needle and dilator to move away from risk areas and ensure the~     prevention of possible vascular complications. Measuring the distance from the skin into the~     trachea can be done and this allows us to choose the average size tracheostomy tube.~      The aim of this study, In the process of applying percutaneous tracheostomy, to compare the~     reliability of the traditional landmark method, ultrasound-guided long axis in plane~     application and ultrasound-guided short axis out of plane application.~   "
15397|NCT02855736|"~     Suicide is a major health concern. Weeks following psychiatric admission are a highly~     suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot~     study suggested the feasibility of positive psychology in patients in suicidal crisis.~     Notably, gratitude exercises suggested improvement in optimism and hopelessness, two~     dimensions associated to suicide. Moreover, gratitude has been associated to suicidal~     ideation and attempt, independently from depression. Thus, investigators want to conduct the~     first randomized controlled study in order to assess effectiveness of gratitude exercises~     (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal~     ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.~   "
15398|NCT02855723|"~     Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated~     surgically with systematic lymph node dissection while in 70%, there is no lymph node~     metastasis. The technique of identifying the sentinel node (GS) is validated for these~     tumors because the status of the sentinel node is predictive of the other nodes status in~     the neck. This helps to diagnose the presence of metastases without lymph node dissection~     and thus select patients requiring a treatment node. However, the oncological and functional~     results of a therapeutic strategy based on identifying the GS is unknown.~      This open-label randomized multicenter clinical trial aims to compare the oncologic and~     functional outcome of two strategies : the current management versus the management based on~     the sentinel lymph node.~      The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding~     10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2~     years with estimated incremental cost-effectiveness and incremental cost-utility, then a~     step with log term modeling.~      A reduction in morbidity and treatment costs in the sentinel node arm are expected in this~     study.~   "
15399|NCT02855710|"~     This project aims at assessing the opposite relation, namely the effect of a training of the~     general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done~     by the means of a serious game. Serious games are more and more used to improve the~     compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost~     tool for rehabilitation.~   "
15400|NCT02855697|"~     PARP inhibitors, such as olaparib, significantly improve progression free survival (PFS) in~     participants with recurrent, platinum-sensitive high-grade serous/endometrioid ovarian~     cancer (HGS/EOC), who harbour a germline mutation in BRCA 1 or 2 genes. Despite some of the~     most impressive hazard ratios seen in ovarian oncology, such improvements in PFS have not~     translated into improved overall survival (OS) advantage potentially because maintenance~     poly ADP ribose polymerase inhibitors (PARPi) are only being administered during a single~     remission. Here the investigators will test the feasibility of administering a second course~     of olaparib in participants who have recurrent platinum-sensitive HGS/EOC.~   "
15401|NCT02855684|"~     Primary Objective:~      To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated~     hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients~     with type 2 diabetes mellitus.~      Secondary Objectives:~        -  To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia~          and nocturnal hypoglycemia.~        -  To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values~          (all and reaching target without hypoglycemia).~        -  To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose~          (all and reaching target without hypoglycemia).~        -  To compare the frequency of occurrence and diurnal distribution of hypoglycemia by~          category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe,~          probable and relative).~        -  To assess the safety and tolerability of insulin glargine (U300).~        -  To assess the development of anti-insulin glargine antibodies (AIA).~   "
15402|NCT02855671|"~     The application of infrared thermal imaging in the diagnosis and prognostication of septic~     illness in adults.~      During times of severe infection (sepsis), the small blood vessels supplying oxygen and~     nutrients to the skin and other organs (called the microcirculation), become abnormal and do~     not function as they normally would in health. Monitoring these small blood vessels is~     difficult to do clinically and the investigators want to investigate a new way of doing~     this.~      The aim of this study is to validate a novel method of assessing the function of the~     microcirculation in healthy volunteers and patients with sepsis, by measuring the skin~     temperature profile of the leg and face with a thermal imaging camera. Thermal imaging~     cameras measure the heat given off by all objects and represents this as a picture, with~     colour used to represent the different temperatures.~      Patients will be recruited from the Emergency Department and Intensive Care Units at~     University Hospitals of Leicester in to one of two groups based on their illness severity;~     uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third~     group. Recruitment will take place over a 6-month period with follow-up lasting for~     12-months following recruitment. 105 participants will be recruited in total.~      Temperature patterns seen on the face and leg will be investigated between the different~     groups. Changes in these temperature patterns as patients recover from sepsis (or indeed~     become worse), will also be investigated. Information from the thermal images will be~     correlated to routinely measured markers of infection, including clinical measurements~     (blood pressure, pulse, etc) and routine blood investigations.~   "
15403|NCT02855658|"~     To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome~     under Chinese herbal medicine (SS-1) treatment.~   "
15404|NCT02855645|"~     Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of~     diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen,~     According to traditional Chinese writing record that Trichosanthes root has the action of~     downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes~     root may lower blood sugar levels in the modern study. The investigators designed a double~     blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar~     were divided into treatment and control groups, and each group was 30 patients. In the~     treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days~     continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g,~     bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood~     sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root~     treatment. The investigators predict the results of the present study indicated that~     Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.~   "
15405|NCT02855632|"~     The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating~     Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after~     hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.~   "
15406|NCT02855619|"~     Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from~     mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning~     in intensive care have been performed, with inconsistent results, utilizing different~     methods of IMT in different populations.~      In this study, the investigators want to compare the incidence of 3 inspiratory muscle~     training programs on inspiratory strength, on difficult to wean patients in intensive care~     unit.~      This is a multi-center randomized trial not blinded with 3 parallels groups:~        -  Martin's group: a threshold-based IMT is performed like used by Martin in a randomized~          trial in 2011, in a view of inspiratory strength increase.~        -  Cader's group: a threshold-based IMT is performed like used by Cader in a randomized~          trial in 2010 , in a view of inspiratory endurance increase.~        -  EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory~          strength and endurance increase.~      The investigators think that a new threshold-based IMT performed in a view of both~     inspiratory strength and endurance increase, is more effective and well tolerated than the 2~     others protocols.~   "
15407|NCT02855606|"~     The purpose of this study is to determine the factors associated with acceptability to oral~     HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and~     transgender women (TGW).~   "
15418|NCT02855463|"~     The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the~     Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating~     information about the definition and evolution of viruses. Its genome encodes about 1,000~     proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant~     viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which~     led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and~     compounds of bacterial origin or cellular proteins This project focuses on the detection and~     analysis of new viral agents (viruses and virophages giant amoeba environmental) and their~     involvement in human pathology.~      The objectives of this study are observational: detect and document the presence of giant~     viruses and virophages of amoebae in the faeces of children presenting to the pediatric~     emergency reception service of the North Hospital in AP -HM with or without clinical~     evidence of gastroenteritis.~   "
15419|NCT02855450|"~     An 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel~     groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy~     of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus~     vehicle in patients with glaucoma.~   "
15408|NCT02855593|"~     The proposed qualitative inquiry seeks to understand medical acupuncture from both the~     physician and the patient perspective. Interviewees will be asked to describe their~     experiences from the point of diagnosis or training up until the present day to capture the~     nature of their experiences across the treatment trajectory. Sample size for the qualitative~     data collection will be based on saturation of themes (thematic findings, e.g., patient talk~     is limited by family knowledge or physician-patient communication is limited by time~     constraints in the clinical setting), meaning investigators will continue recruitment until~     they are no longer hearing new experiences from participants. Saturation will be kept~     separate by groups (i.e., saturation of themes must be met within the group of patients~     separately from providers). Investigators will conduct preliminary data analysis after each~     10 interviews to determine when saturation is reached. Recruitment numbers here are~     anticipated maximum numbers needed to reach saturation. Investigators plan to recruit and~     sample provider and patient populations in the following way. Investigators will group~     physicians by the physician's training so that we are sensitive to the fact that helpful~     patient-physician interaction approaches may differ across the patient's lifespan or with~     patient or physician experience with acupuncture. Audio recordings from each interview will~     be professionally transcribed and analysis will be concurrent with data collection to ensure~     reliability and validity of findings. Investigators will review transcripts as data are~     collected to identify emergent themes and ensure thematic saturation.~   "
15409|NCT02855580|"~     The purpose of this study is to examine the feasibility, acceptability, and utility of~     pharmacogenomic (PGX) testing (specifically for the cytochrome P450 2D6 and 2C19 genes)~     prior to initiating treatment with an antidepressant (AD) among children and adolescents in~     the University of Florida Child Psychiatry clinics.~   "
15410|NCT02855567|"~     This study investigates the role of acupuncture in controlling post-operative pain in~     patients who have undergone gynecological surgery.~   "
15411|NCT02855554|"~     The overall goal of this project is to evaluate the clinical potential of fast quantitative~     myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging~     (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial~     diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.~   "
15412|NCT02855541|"~     Previous research suggests that prolonged sitting increases risk for cardiometabolic~     diseases and the risk factors associated with cardiometabolic diseases. However, no study to~     date has examined if a chronic intervention that breaks up prolonged sitting in a real-world~     environment results in a reduction in the metabolic risk factors associated with~     cardiometabolic diseases. Thus, the objective of this study is to examine the potential~     health benefits of breaking up sitting bouts throughout the workday using a small cycling~     device (DeskCycle) in office workers involved with jobs that require prolonged bouts of~     sitting. The investigators hypothesize that breaking up sitting will be associated with~     improvements in cardiometabolic disease risk factors. More specifically, the investigators~     hypothesize that breaking up sitting will decrease blood glucose during an oral glucose~     tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure,~     decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total~     cholesterol, and triglycerides.~   "
15413|NCT02855528|"~     The aim of this study is to prospectively investigate the diagnostic performance and~     potential radiation dose reduction in coronary artery calcium scoring using the new tin~     filter system of the 3rd generation DSCT scanner.~   "
15414|NCT02855515|"~     The main diagnostic challenge in patients with OSA (obstructive sleep apnea) is to determine~     the location of obstruction of the upper airway during sleep. This is so, because the~     otorhinolaryngology examination, which states probable site of obstruction of upper airways,~     is performed in the awake status. Therefore, drug-induced sleep endoscopy (DISE) has been~     introduced in the diagnostic algorithm of OSA patients during the last decade. The advantage~     of DISE is, that the collapse of upper airways, which is not visible during the awake status~     can be observed and targeted therapy according to the location and degree of obstruction of~     the upper airway can be applied. As a result, higher treatment success in patients with OSA~     can be reached.~   "
15415|NCT02855502|"~     tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic~     scar formation and obstruction of the airway lumen by excess granulation tissue. This~     process is progressive so treatment and prevention is essential. Resection-anastomosis of~     the trachea is becoming the standard of care in many centers and gives the most consistent~     results in both adult and pediatric patients. But recurrence stenosis, re-granulation and~     re-inflammation are probable. This study aimed to assess the efficacy of systemic~     prednisolone on prevention of recurrent tracheal stenosis after surgery.~   "
15416|NCT02855489|"~     This study has three primary goals. First, to design distinct interventions that target the~     three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and~     perceived behavioral control (PBC)). The second goal is to determine which combination of~     the Theory of Planned Behavior constructs is more successful at changing condom use behavior~     among college students. Finally, the investigators will examine the impact change in~     targeted constructs has on those not targeted by an intervention. The current study intends~     to empirically test how the constructs (i.e., attitudes, norms, PBC) in the Theory of~     Planned Behavior influence each other to increase condom use with college students.~   "
15417|NCT02855476|"~     HDClarity will seek to enroll approximately 600 research participants - 500 of whom will be~     at different stages of Huntington's disease (HD) and 100 healthy controls. The primary~     objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways~     that will enable the development of novel treatments for HD. The secondary objective is to~     generate a high quality plasma sample collection matching the CSF collections, which will~     also be used to evaluate biomarkers and pathways of relevance to HD research and~     development.~   "
15531|NCT02853994|"~     The study is a prospective, non-randomized, multicenter, post-marketing surveillance study~     evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding~     device approved indications:~        -  In-stent restenosis lesions: either bare metal or drug eluting stent restenosis~        -  Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in~          side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary~          arteries~        -  Small vessels: treatment of lesions ≤2.75 mm~        -  BMS implantation followed by DCB inflation~   "
15420|NCT02855437|"~     The purpose of this study is to determine the feasibility and acceptability of using~     different remote data collection technologies to ascertain flare occurrence among gout~     patients. Two technologies will be the focus of this study: a telephone based interactive~     voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of~     this study will not only guide research approaches in clinical trials, but may also have~     direct implications for monitoring patient outcomes in the context of day-to-day clinical~     practice.~      The investigators hypothesize that acceptability will be greater for RheumPRO application~     than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with~     a greater frequency of patient-initiated interactions.~   "
15421|NCT02855424|"~     Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in~     chronic. In addition, the poor fitness may obstacle activities of daily life, decrease~     activities of autonomic system, and increase risks of recurrent, therefore, the~     cardiopulmonary endurance training should be included into the early-stage rehabilitation~     program. The ergocycling training could improve cardiopulmonary endurance for individuals~     with stroke. Moreover, the low-intensity exercise training can increase the willingness, and~     it is safer than the moderate-intensity exercise training. However, it needs to be evaluated~     whether the low-intensity exercise training can bring sufficient benefits, compared to the~     moderate-intensity exercise training. Objectives of the study is to compare the exercise~     benefits between the low-intensity and moderate-intensity exercise training, and then these~     would offer optimal exercise prescription and considerations in clinical practice.~   "
15422|NCT02855411|"~     The purpose of this study is to determine whether PF-04958242 is safe and effective in the~     treatment of cognitive dysfunction in schizophrenia subjects~   "
15423|NCT02855398|"~     The purpose of this 18-month project is to investigate how decision-making influences food~     choice and consumption in children ages 7 to 11 years old. Although several studies suggest~     that the ability to make good decisions relates to eating behaviors, no studies have looked~     at how food reward influences the decision-making process to impact actual food intake. This~     proposal will answer these questions and bridge this gap in knowledge, which could lead to~     the development of more effective interventions for childhood obesity. To accomplish this,~     the investigators have assembled a diverse team with expertise in food intake, nutrition,~     and decision sciences. First, the investigators will establish if there are differences in~     decision-making between children varying in weight status. Second, the investigators will~     determine if performance on behavioral decision-making tasks relates to food consumption in~     the laboratory. Third, the investigators will examine response functional magnetic resonance~     imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e. food~     and money) and determine if this is influenced by child weight status. Fourth, the~     investigators will examine differences in fMRI BOLD at rest in decision-making regions are~     correlated with food intake and weight status. Eighty-two children will participate in our~     study. The long-term goal of this project is to investigate if there are differences in~     brain regions corresponding to these behaviors in overweight children and if these~     differences relate to eating behaviors in this population. Children will undergo fMRI while~     playing a reward task as well as consume meals in our laboratory. Decision-making will also~     be assessed by having children complete various behavioral measurements of reward and~     inhibitory control.~   "
15424|NCT02855385|"~     This study sought to find the health seeking behavior of patients with rectal bleeding as~     related to their risk to develop colorectal cancer and also assess the general~     practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.~   "
15425|NCT02855372|"~     It is commonly accepted that the characteristics of the organ donor impact on the future~     post transplant. In lung transplantation (LP), the defining characteristics of the ideal~     donor includes an age less than 55 years. However, before the pulmonary graft shortage with~     a corresponding mortality still too high waiting list, the lung graft acceptance criteria~     were reassessed permitting criteria extension ( marginal graft). And were grafted,~     depending on the urgency and accessibility problems in the registry of potential candidate,~     organs from donors aged 55 and older with quite comparable to those obtained from younger~     donors . Nevertheless, it is common practice that the grafts from older donors are more~     readily allocated to older candidates and the most severe, as many confounding factors to~     assess the real impact of donor age on post-transplant evolution on small cohorts.~      The main goal of this study is to compare the survival of lung transplant patients depending~     on the age difference between donor and recipient.~      The study will be conducted from a broad national cohort of lung transplant patients~     registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted~     by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on~     French territory. It provides a standardized common longitudinal monitoring of the recipient~     from his transplant. Currently more than 1,000 patients included in this study are~     transplanted.~   "
15426|NCT02855359|"~     This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination~     with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse~     large B-cell lymphoma or follicular lymphoma Grade 3b.~   "
15427|NCT02855346|"~     PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel~   "
15428|NCT02855333|"~     The purpose of this study is to analyse retrospectively the early postoperative and~     functional outcome of patients (pts) after Merendino procedure for benign or early malignant~     lesions of the distal part of the esophagus or the gastroesophageal junction.~   "
15437|NCT02855216|"~     The cervical spine should work as a functional unit. If hypomobility should exist in any of~     the segments it would limit the mobility of the spine as a whole. Although it is frequent~     that certain cervical segments present hypomobility, they are not always related to~     symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have~     not been evaluated.~      The objetive of this trials is to assess and compare the effects on cervical mobility, of~     the manual technique of sub-occipital inhibition by applying pressure and self-treatment by~     way of Occipivot® cushion, in subjects with no cervical symptomatology but with limited~     mobility assessed by the flexion-rotation test.~   "
17034|NCT02834377|"~     The purpose of this study is to evaluate the effectiveness of using the personal~     preoperatively assessed cardiac output in high-risk patients to guide perioperative~     administration of fluids and vasoactive drugs on predefined postoperative complications.~   "
15429|NCT02855320|"~     Background : Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA)~     are painful chronic diseases which impair quality of life and work capacity. Biologics are~     very effective and widely used therapies. However, they are known to entail risks,~     particularly of infections. The risk of severe infections is of 5%/patient-year with a~     maximum during the first six month after the initiation of the first biologic therapy.~      Patient education (PE) is recommended for the management of chronic diseases. In the case of~     biologics, PE aims to help patients to learn specific skills particularly on safety issues,~     e.g stopping the biologic treatment in case of fever or surgery. Safety skills are assessed~     by the validated BIOSECURE questionnaire. PE seems efficient for safety skills in a few~     non-randomized studies. In 2010 a national cross sectional survey on 677 patients showed~     that the risk of incorrect answers in the BIOSECURE questionnaire was 4 times lower among~     patients who had benefited from an education by a nurse or other kind of educational process~     (OR =3,8 IC95% :[1,68-8,8].~      Aims and Hypothesis: this trial aims to investigate the effects of a nurse-led~     self-management education face to face intervention on safety skills of patients with~     arthritis treated par sub cutaneous biologics. Our hypothesis is that the intervention group~     will report better skills at the 6 months follow up compared to usual care i.e information~     by the rheumatologist in current consultation.~      Methods : multicentric randomized controlled open trial with blinded assessment of the~     primary outcome. The intervention group will have a nurse education consultation at M 0 and~     M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients'~     health beliefs and educational needs, focusing on safety skills, self-injections and~     motivation. The control group will have usual care by the rheumatologist.~   "
15430|NCT02855307|"~     Regular physical activity is associated with many health benefits for individuals with type~     1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin~     requirements, improved body composition and quality of life. However, exercise-induced~     hypoglycemia is very frequent and thus is the main limiting factor for physical activity~     practice in this population.~      The artificial pancreas is composed of three components: glucose sensor to read glucose~     levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the~     required insulin dosages based on the sensor's readings. A dual-hormone artificial pancreas~     would regulate glucose levels through the infusion of two hormones: insulin and glucagon.~     The artificial pancreas has the potential to reduce the risk of exercise-induced~     hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to~     be explored.~      The objective of this study is to investigate 1) if announcing postprandial exercise to the~     artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) in the context~     of unannounced exercise, if dual-hormone artificial pancreas will reduce hypoglycemic risk~     compared to single-hormone artificial pancreas.~   "
15431|NCT02855294|"~     1. Recording Data Sheet:~           All data and information of each woman in both groups (A & B) participated in this~          study were recorded in a recording data sheet (Appendix II).~        2. Weight-Height scale:~           A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight,~          and 1 to 200 centimeters height was used to measure the relevant subject's data.~        3. Siemens Immulite Immunoassay System:~           (Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A)~          to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE~          21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.~        4. Biodex balance system:~      Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to~     measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows~     approximately 20 degree inclination in 360 degree range and is interfaced with computer~     software. It measures the patient's ability to control the platform's angle of tilt, which~     is quantified as a variance from the center, as well as the degree of deflection over time~     at various stability levels as shown in (Fig. 6).~      Stability levels allowed by the system ranged from one to eight. Stability level 8, allows~     the highest level of stability as it makes the platform to be the least tilted. On the other~     hand, stability level one represents the least level of stability and is more difficult for~     the subject to maintain stability on.~      The test consists of recording the patient's ability to control the platform variance from a~     perfectly balanced position. A large variance is indicative of poor control and balance.~     Further definition is realized with the quantification of Anterior/ Posterior and~     Medial/Lateral responses.~   "
15432|NCT02855281|"~     This is a prospective diagnostic pilot study to create hypotheses regarding~     immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared~     to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done~     to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.~   "
15433|NCT02855268|"~     This will be a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study~     conducted in subjects with Alport syndrome at multiple investigative centers.~   "
15434|NCT02855255|"~     The proposed study will compare the efficacy of two psychological stop smoking~     interventions, amongst people living and working in the Lambeth and Southwark boroughs of~     London.~   "
15435|NCT02855242|"~     The human gut microbiota has become the subject of extensive research in recent years,~     particularly in regards to the role it plays in obesity. Although lifestyle factors, diet,~     and lack of exercise contribute largely to this obesity epidemic, there is increasing~     evidence that the human gut microbiota also influences weight gain.~      The investigators hope to learn more information about the change in gut microbiota,~     especially with regards to those who are successful with weight loss, versus those who don't~     lose weight, after participating in a lifestyle modification program at the Dan Abraham~     Healthy Living Center (DAHLC).~   "
15436|NCT02855229|"~     The overarching goal of this multi-disciplinary research program is to develop and optimize~     new cross-species translational assessments of reward and cognition that will not only be~     assessed in parallel in humans and rats, but also produce neurophysiological and behavioral~     metrics that can be objectively compared across species. The research will build on prior~     studies by further developing and optimizing (in Phase 1), then validating via~     pharmacological challenge (in Phase 2), the following assays in both humans and rats:~        1. advanced neurophysiological and computational modeling techniques to record and analyze~          EEG activity within and across species; and~        2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility~          will be analyzed within and across species.~      The second phase of the study will test the translational validity of these assays, by~     assessing the impact of a targeted drug on task performance and EEG activity in both~     species.~   "
15438|NCT02855203|"~     This investigator driven study will examine the safety, efficacy and biological effects of~     combining pembrolizumab (MK-3475) an antibody targeted against anti-programmed cell death 1~     (PD-1), with stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell~     carcinoma (RCC). The investigators hypothesise that the safety profile of this combination~     will be clinically acceptable.~   "
15439|NCT02855190|"~     This is an open-labelled two-arm pilot comparative prospective study. All the subjects will~     undergo image assessment in the two stages of exchange arthroplasty surgery. At the first~     stage, each enrolled subject will receive both FDG and Ga68 citrate PET/CT scans before the~     first operation for periprosthetic Joint Infection (PJI). Thus, the test results of FDG and~     Ga68 for each individual can be obtained. After the first operation, the surgery/biopsy~     proof can be obtained as the gold standard. The subjects those with PJI negative will~     complete the process at the first stage.~      And the second stage of this study will be based on the subjects with positive PJI from the~     first operation. They will receive both FDG and Ga68 citrate PET/MR scans after antibiotic~     bone cement was implanted. The sensitivity/accuracy of the two tracers for PET/MR can be~     calculated and compared. This stage is aimed to answer whether PET/MR scan is a feasible~     imaging tool to provide diagnostic information of infection control status after the~     resection arthroplasty of hip/knee PJIs, especially with the implantation of antibiotic~     loaded bone cement.~      In the second stage, the investigators shift the imaging modality to PET/MR based on the~     following reasons: (1) MRI itself has no radiation burden; (2) MRI provides more accurate~     tissue contrast information and therefore better anatomic delineation; and (3) currently~     there was no study indicating the existence of ABLC may hamper the interpretation of images.~      The study duration is expected to be completed in a period of 3 year. It plans to enroll a~     total of 50 subjects with suspicious infection. And the investigators expect the PJI~     prevalence will be around 60%, i.e. the anticipated number of subjects of true PJI is around~     30. The sample size and the prevalence is given based on the clinical availability and~     consideration.~   "
15440|NCT02855177|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2~     weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.~   "
15441|NCT02855164|"~     The purpose of the study is to assess the effects of different doses of LJN452 with respect~     to safety, tolerability, and on markers of liver inflammation in patients with NASH~   "
15442|NCT02855151|"~     The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on~     the management of gastrointestinal disease. The registry will evaluate efficacy, safety and~     technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and~     prospective registry study.~   "
15443|NCT02855138|"~     The investigators consider that there are some rising concerns about the use of isotretinoin~     by women of reproductive age with depleted ovarian reserve, hence it is important to detect~     the effect of isotretinoin on ovarian reserve.~      There has not been a well-designed study evaluating its effects on the human ovarian~     reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS).~     For this reasons, this study was administered to determine whether there is an effect of~     isotretinoin on the gonads and hirsutism in women with acne and PCOS.~   "
15444|NCT02855125|"~     This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with~     S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in~     patients with advanced or metastatic NSCLC.~      The study will be conducted internationally in 2 regions: Asian [Japan] and Western [Europe~     and US]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1~     ratio.~   "
15445|NCT02855112|"~     Spinal Muscular Atrophy (SMA) is an autosomal recessive disease of motor neurons. In the~     early 1980s, Werdnig from Vienna University and Hoffman from Heidelberg University described~     this disorder. So SMA type 1 was named Werdnig- Hoffman disease. This is the first genetic~     disorder that cause death after cystic fibrosis in infants with the prevalence of 1 in 6000~     birth. Mutation in the SMN1 gene (Survival Motor Neuron) is the reason for the disease that~     cause decrease in the SMN protein production. So the alpha motor neurons in the spinal cord~     ventricle horn will be destroyed and it cause progressive paralysis and defenite death.No~     specific therapy is yet available for the treatment of Werdnig-Hoffmann disease. Treatment~     is not disease-modifying and just is supportive. SMA type 1 is diagnosed within the early 6~     month after birth and accompanied with breath disorders and definite death in 2 years. The~     affected infants have a weak muscle tone and they couldn't even hold their head up. Perhaps~     the only open way for these patients is the application of stem cells that could deliver~     trophic factor to the apoptotic cells. So this study focuses on the effectivness of cell~     therapy via adipose derived mesenchymal stem cells on the probable phenotypic changes in~     these patients.~   "
15446|NCT02855099|"~     Many patients we encounter a month post TAVI, still complain of having symptoms limiting~     their daily activity. The investigators set out to study whether rehabilitation strategy~     early after the procedure contributes to reduction of the physical disability these patients~     suffer from.~      Cardiac rehabilitation (CR) is a well-established treatment in patients who underwent~     cardiac surgery. Patients after TAVI, are natural candidates for referral to exercise-based~     CR. Despite this, until 2013 no data have been available about the safety and the efficacy~     of a comprehensive rehabilitative period in these subjects. CR is a helpful tool to maintain~     independency for daily life activities and participation in socio-cultural life. despite~     these differences, both patient groups did benefit in the same way from a post-acute~     in-patient rehabilitation program as assessed by 6-Minute Walking Tests and FIM scores.~     Patients who were unable to walk and those were slow walkers at baseline experienced an~     improvement in functional status after TAVI, whereas the fast walkers did not improve and~     actually experienced a modest decrease in 6MWTD.It has been shown that patients referred for~     rehabilitation after TAVI are often very frail, with a high grade of functional impairment,~     dependence on others and high risk of clinical complications. During a rehabilitation~     program, based on a multidimensional assessment and intervention, most patients showed~     significant improvement in functional status, quality of life, and autonomy, which remained~     stable in the majority of subjects during mid-term follow-up.~      To the investigators knowledge, no prospective study compared rehabilitation strategy to~     conservative treatment after TAVI. the investigators set off to test the investigators~     hypothesize that CR may help in the short and long term prognosis of these patients.~   "
15447|NCT02855086|"~     This pilot phase I/II trial studies the best dose of cetuximab-IRDye 800CW and how well it~     works in detecting tumors in patients with malignant glioma who are undergoing surgery.~     Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a~     special camera is used.~   "
15448|NCT02855073|"~     The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee~     Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.~   "
15449|NCT02855060|"~     The purpose of this study is to determine whether the use of pelvic binders in the ambulance~     setting improves outcomes including mortality in patients with pelvic fractures.~   "
15474|NCT02854735|"~     The purpose of this study is to define the role of total body composition in the guidance of~     nutritional support and treatment monitoring in head and neck patients. Furthermore, the~     second aim of this study is to compare the clinical performance of dual energy X-ray~     absorptiometry as compared to CT in evaluating total body composition of patients.~   "
15532|NCT02853981|"~     The purpose of this study is to determine whether clamp-crush technique for liver~     parenchymal transection is as safe as Harmonic scalpel device. outcomes will include:~     perioperative mortality, surgery-related complications, blood loss, amount of blood loss~     during hepatectomy, operating time, transection speed, markers of liver parenchymal injury~     and hospital stay.~   "
15450|NCT02855047|"~     The primary objective of this study is to evaluate plasmatic concentrations of free PGF and~     sFlt1 for blood samples taken before a first low-molecular-weight-heparin injection and also~     for blood samples taken on the 4th day of injections (the latter correspond to the first~     systematic control of platelet counts) in women who have an obstetric antiphospholipid~     antibody syndrome and who are initiating a new pregnancy with recommended treatment. Our~     goal is to test the prognostic value of these data on the occurrence of:~        -  pregnancy loss categorized as embryonic loss (before 10 weeks gestation), fetal death~          (before 20 weeks gestation), stillbirths (from 20 weeks gestation to delivery), and~          neonatal death defined before reaching 28 days of age.~        -  ischemic placental pathology (pre-eclampsia, retro-placental hematoma, birth of a~          small-for-gestational-age infant)~   "
15451|NCT02855034|"~     Head injury is a frequent motive of consultation in paediatric emergency units and the first~     cause of mortality in infants of more than one year old in developped countries. The~     indication of performing cerebral CT scans currently depends on clinical decision based on~     recommendations used in adults. In this way, 60 to 90% of scans are normal in children with~     head injury. CT scan is expesive and irradiating with the risk of increasing the cancer in~     children. Protein S 100B and copeptine are biomarkers which have shown their ability to~     detect cerebral lesion in children with head injury. (protein S 100B and /or in adults~     (protein S 100B and copetine.~      It is the first clinical biological evaluation of severity of head injury based on dosing of~     copeptine alone or associated with proein S 100B.~   "
15452|NCT02855021|"~     Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients~     during their evolution. In addition, treatments of motor signs have a potential impact on~     these disorders and conversely.~      The purpose of this study is to show focal abnormalities in brain metabolism in the~     precuneus and posterior cingulate region are predictive of the onset of dementia within 2~     years.~   "
15453|NCT02855008|"~     Aggressive/challenging behaviors in individuals with intellectual disability are a major~     public health concern for them, their families, their service programs and staff, and their~     communities. This randomized clinical trial will test the efficacy and cost effectiveness of~     a preventive community-based social problem solving intervention, the Steps to Effective~     Problem-solving (STEPS), delivered in group homes. The program uses residential staff~     participation and the group environment to facilitate improved social problem solving skills~     and reduce aggressive/challenging behaviors in this population in group homes and work~     settings.~   "
15454|NCT02854995|"~     Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this~     approach has long been held as the 'gold standard. Whilst this may be curative in many~     cases, it has been shown that 20% of boys require a further operative procedure on their~     penis to widen the urethral opening (to treat meatal stenosis)~      An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening~     of the foreskin) was combined with injection of steroids into the affected foreskin.~     Subsequently, the same group compared the outcomes of this technique with circumcision, and~     reported circumcision was successfully avoided in 92% of the preputioplasty group. In~     addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery)~     was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer~     protection against meatal stenosis and reduce the requirement for further surgery; and (ii)~     offer the benefit of retaining the foreskin, the function of which, while debated, likely~     includes sexual function. In view of these potential benefits, authors have called for a~     randomised trial to compare circumcision to preputioplasty and injection of steroids.~   "
15455|NCT02854982|"~     To study the quality of life of patients with prostate cancer at a distance from their care~     at a time when they are supposed to have taken a normal life and compared to subjects~     without cancer prostate of the same age.~   "
15456|NCT02854969|"~     Through several questionaries the investigators will measure the satisfaction of patients~     diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a~     smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.~   "
15457|NCT02854956|"~     X-linked Mental retardation (XLMR) represent 10% of the causes of mental retardation with a~     prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (Opitz et al., 1986). This~     heterogeneous group of XLMR includes dozens of rare diseases, some of them affecting only a~     few patients. Molecular diagnosis is currently available in France for 25 XLMR genes, within~     the national network of XLMR molecular diagnosis. However, whereas some syndromes such as~     Fragile X syndrome, are now well clinically defined, this is not the case for recently~     identified syndromes for which very few data is available, preventing clinicians to focus~     molecular diagnosis on a specific gene.~      Therefore, this study aims to :~        -  Achieve a description of the clinical phenotype specific to each XLMR gene (Phase 1 of~          the study, n=200)~        -  Characterize the cognitive learning mechanisms and dysfunctional neural networks~          involved (Phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in~          the same gene). These two elements constitute key steps to develop appropriate~          rehabilitation strategies and targeted pharmacological therapies.~      Moreover, the impact of mental retardation on the primary caregiver within the family and~     the induced burden in terms of psycho-social, organizational and economic burden will also~     be assessed. These elements, directly related to the patient's environment, are very~     important to characterize in order to better understand the consequences of each gene~     mutation (Phase 3 of the study, n=283). For example, it is necessary to better understand~     the impact of Fragile X syndrome in terms of capacity and behavior, lifestyle, and health~     care needs of the patients While advancing knowledge allows to consider innovative~     therapeutics, the implementation of these therapeutics and assessment of their impact on the~     patients' life trajectory, require precise characterization of the population to be treated~     in medico socioeconomic terms.~   "
15458|NCT02854943|"~     Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.~   "
15459|NCT02854930|"~     Migraine is a common disabling primary headache disorder. Epidemiological studies have~     documented its high prevalence and high socio-economic and personal impacts. Migraine~     affects more than 20% of the French population. However, the physiopathology of migraine is~     always partially known. Cortical spreading depression (CSD) is the widely accepted as the~     electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient~     neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known~     phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening~     conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep~     intrusion have been discussed. However, the role of DCE has never been discussed. The goals~     of this study are : to see if there is an epidemiological link between NDE and migraine/ to~     specify if NDE was followed by a migrainous headache.~   "
15460|NCT02854917|"~     This study is a retrospective review of the data collected in a previously completed~     randomized, controlled trial (RCT) entitled Memantine and Comprehensive, Individualized,~     Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial~     (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's~     Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an~     individualized management program consisting of home visits, educational sessions for~     caregivers, and a caregiver support group. Participants received the study intervention for~     28 weeks; study follow-up lasted for 52 weeks.~      The collected data from the existing study books from the 28 week treatment portion of the~     RCT will be carefully examined with respect to each of the research questions for the~     present retrospective study.~   "
15461|NCT02854904|"~     Alpha-agonist in anesthesia display immunomodulatory effect in addition to antiadrenergic~     control. This effect of the immune system can be a key to a better perioperative safety and~     quality.~      The association of dexmedetomidine at general anesthesia adds up organic protection and~     inflammatory control to a surgery trauma owing to antinociception and immunomodulatory~     effect.~      The aim this study is evaluate if the association of dexmedetomidine at general anesthesia~     standing effective immunomodulatory control to trauma and improve changes at outcomes in~     patients undergoing to spinal fusion.~   "
15462|NCT02854891|"~     Myopia, the most common human eye disorder, is a phenomenon characterized by an~     unconstrained elongation of the eye globe There are number of theories concerning the~     environmental effect on the emmetropization process, most are related to childhood exposure~     to outdoor activity, near work and sleep with night light. Studies in lab animals found an~     association between intensity of ambient lighting and myopia development.~      In this study, the investigators will examine the ambient light in kindergarten and schools~     and their relation to refractive error. Diurnal luminance in kindergarten and school class~     room will be measured and correlated to biometric measures such as refraction, axial length~     and keratometry.~   "
15463|NCT02854878|"~     A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing~     head lice and their eggs.~      23 participants will be enrolled in this study. The first 12 will be combed with model A and~     the remaining 11 will be combed with model B~   "
15464|NCT02854865|"~     Determining the LV filling pressure is a key element in the diagnosis and management of~     patients with suspected decompensated heart failure. The aim of the present study is to~     assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain~     (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio~     in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in~     patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method~     based on 2D strain imaging that enables the simultaneous quantification of myocardial strain~     in different left ventricular segments; its 3-click method minimizes variability related to~     a manual tranig of endocardial border required in an usual 2D-strain analysis.~      AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The~     study is a prospective observational single-center cohort study. 30 Patients scheduled for~     elective cardiac surgery will be included in the study group. The study is designed to~     assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in~     estimation of LVFP measured as PCWP.~   "
15465|NCT02854852|"~     Changes in the vascular tone of anesthetized patients is common and cause hemodynamic~     problems. The monitoring of such changes in vascular resistance using simple and~     non-invasive tools is lacking. The present study was designed to determine if~     photoplethysmography can detect changes in the systemic vascular resistance using Doppler as~     the reference method.~   "
15466|NCT02854839|"~     The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural~     killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial~     chemoembolization (TACE).~   "
15467|NCT02854826|"~     Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to~     rapidly identify and provide safe and effective inpatient care to high risk older adults and~     help support their successful transition back to the community. Developed and demonstrated~     to be effective in one hospital - the model is now being disseminated and studied in three~     additional hospitals (multiple organizational case study).~   "
15468|NCT02854813|"~     Investigators aimed to investigate the association between over active bladder and coronary~     artery disease as demonstrated on coronary angiography.~   "
15469|NCT02854800|"~     The purpose of this study is to examine the effectiveness of a smoking cessation~     intervention for cigarette smokers enrolled in an outpatient program for opioid dependence.~     Treatment effects will be compared as a function of phase in the outpatient program: 0-90~     days, 90 days-1 year, and more than 1 year.~   "
15470|NCT02854787|"~     The purpose of the study is to determine if an intravenous bolus of phenylephrine is more~     effective compared to an intravenous bolus of norepinephrine associated with crystalloid~     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.~     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and~     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all~     participants will receive spinal anesthesia with a local anesthetic and sufentanil. This~     study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a~     computer generated system to be in one of two groups.~   "
15471|NCT02854774|"~     This is a randomized controlled trial of knee muscle versus hip muscle strengthening for~     Patellofemoral Pain Syndrome.~   "
15472|NCT02854761|"~     This study evaluates the safety and tolerability of the investigational drug EF-022 in the~     treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will~     be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months.~     Preliminary effect of the drug on the disease will be evaluated by following the number and~     severity of the lesions in the respiratory tract and the effect on voice changes.~   "
15473|NCT02854748|"~     This study is a randomized, open-label, multiple dosing, crossover study to evaluate the~     drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers~   "
15533|NCT02853968|"~     The purpose of this study is to study stained Castleman's Disease lymph nodes and perform~     flow cytometry and cell culture experiments on Castleman Disease blood samples to determine~     which cellular pathways and immune cell types are driving the disease.~   "
15475|NCT02854722|"~     In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for~     osteoporosis. Osteoporosis is a common complication in various diseases, such as~     hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all~     share iron accumulation as a common denominator. Moreover, a 3-year retrospective~     longitudinal study has shown that iron accumulation was also associated with osteoporosis in~     healthy adults and especially that it can increase the risk of fractures in postmenopausal~     women. Based on these observations, iron chelation therapy may have a promising future in~     the treatment of iron accumulation-related osteoporosis by removing iron from the body.~      The purpose of this study is to determine whether the addition of the iron chelator,~     deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.~   "
15476|NCT02854709|"~     This is a randomized cross over study of the effect of 2-week sleep extension in chronically~     sleep deprived non-diabetic individuals on glucose metabolism.~   "
15477|NCT02854696|"~     The main goal is to perform a cost-utility analysis to compare islet cell transplantation~     versus best medical treatment (defined as Sensor augmented pump therapy) for patients with~     brittle type1 diabetes.~   "
15478|NCT02854683|"~     We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic~     Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate~     prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia~     syndrome (POTS) in which standing results in an excessive heart rate, and neurally mediated~     hypotension (NMH) in which standing causes a fall in blood pressure and fainting.~     Intravenous fluids can alleviate these symptoms, but is difficult to administer; oral fluids~     fail to provide the same benefit. We would therefore like to test the effectiveness of an~     oral rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and~     sodium, to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare~     these results with healthy control subjects.~   "
15479|NCT02854670|"~     This study aims to assess the pain on contact in provoked vestibulodynia, measured with~     Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.~   "
15480|NCT02854657|"~     The proposed study is a continuation of a research program (STU00017005: Interventions to~     teach melanoma patients skin self-examination) designed to increase early detection of~     melanomas before they metastasize. In 2015, approximately 73,870 individuals in the U.S.~     will be diagnosed with invasive melanoma and about 9,940 will die from the disease. During~     2002-2011, melanoma incidence increased at an average annual rate of 1.6% for men and 1.5%~     for women. People with a history of melanoma have 10 times greater risk of developing a~     second primary melanoma relative to the general population.Early detection with surgical~     excision at an earlier stage when treatment is usually more effective is the only proven~     curative strategy.~   "
15481|NCT02854644|"~     This study evaluates the frequency of the spontaneous T cells specific CD4 answers of~     tumoral antigens breast cancer and glioma.~   "
15482|NCT02854631|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-4997 in~     combination with prednisolone versus prednisolone alone in participants with severe~     alcoholic hepatitis (AH).~   "
15483|NCT02854618|"~     This study evaluates the immune response for patients affected by metastatic breast cancer~     treated by everolimus~   "
15484|NCT02854605|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     participants with nonalcoholic steatohepatitis (NASH).~   "
15485|NCT02854592|"~     Stroke is one of the leading causes of death and disability in China. Intravenous~     thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for~     ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in~     addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010~     Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke,~     and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is~     used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese~     experience with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a~     multicenter, prospective, registry study. The aim of INtravenous Thrombolysis REgistry for~     Chinese Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of~     intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute~     ischaemic stroke.~   "
15486|NCT02854579|"~     The purpose of this study is to investigate the efficacy and safety of allogenic neural~     progenitor cell and paracrine factors of human mesenchymal stem cells for patients with~     moderate/severe Hypoxic-Ischemic Encephalopathy~   "
15487|NCT02854566|"~     Observational retrospective study on 36 consecutive patients having had surgery for a~     periprosthetic fracture of the femur between 2010 and 2015.~      The goal of the study is to test whether osteosynthesis was a secure choice at a certain age~     and with any type of Vancouver fracture.~   "
15488|NCT02854553|"~     The transversus abdominis plane (TAP) block is an effective regional nerve block for the~     anterior abdominal wall. An anesthesiologist typically administers the TAP block~     preoperatively with ultrasound guidance. It is not yet commonly used during anterior~     abdominal wall liposuction, where postprocedural pain remains a major concern for patients~     and surgeons.~   "
15489|NCT02854540|"~     This small feasibility study will evaluate the use of hydrogel electrode pads (rather than~     tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis~     device. Participants will treat one hand with the hydrogel-based iontophoresis device and~     leave the other hand untreated.~   "
15490|NCT02854527|"~     Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin,~     furosemide, metformin, and rosuvastatin when given all together as a cocktail~   "
15491|NCT02854514|"~     For all women immediately after ovum retrieval from 80 women undergoing IVF, intra uterine~     salin flushing will be analyzed using a multiplex immunoassay for soluble regulators of~     implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect~     implantation predictors.~   "
15558|NCT02853643|"~     The purpose of this study is to evaluate the safety and tolerability, and determine the~     blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of~     ASN002. Healthy volunteers will be participants in the study.~   "
15492|NCT02854501|"~     The current study included the singleton pregnancies (without history of previous risk~     factors), had their homocysteine measured as part of a serum-screening program in addition~     to uterine artery Doppler. Sensitivity, specificity, positive and negative predictive~     values, for development of preeclampsia and other adverse pregnancy outcomes were assessed~     as follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler~     with a mean RI >0.5, all unilateral notches with a mean RI >0.6, in addition, absence of~     notches with a mean RI >0.7; (3) Doppler assessment combined with the homocysteine cutoff~     (6.3 µmol/l).~   "
15493|NCT02854488|"~     The study is a global safety surveillance study of pregnancy outcomes in women who were~     exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age~   "
15494|NCT02854475|"~     The purpose of this study is to~      I. determine several skin parameters, for example natural moisturizing factor (NMF) and~     cholesterol, with Raman spectroscopy in vivo and~      II. compare the results with the corresponding cholesterol levels measured in venous blood.~   "
15495|NCT02854462|"~     The aim of this project is to test whether training parents to ask their children~     'inference- eliciting' questions during book reading is effective in promoting story~     comprehension for 4-year-olds from a range of socio-economic backgrounds.~   "
15496|NCT02854449|"~     This study will follow-up different immune cell populations in the blood before, during and~     after high dose radiation therapy which should give new information of the efficacy of Local~     Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.~   "
15497|NCT02854436|"~     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of~     niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and~     deoxyribonucleic acid (DNA) repair anomalies.~   "
15498|NCT02854423|"~     Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based~     everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as~     compared with early generation DES. BP-BES with DP-EES have been directly compared in 2~     randomized trials, showing no differences between the two devices in all-comer patients~     during long-term follow-up. It is unknown whether these results are consistent in real-world~     patients with diabetes mellitus during long-term follow-up. To evaluate the safety and~     efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as~     compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with~     diabetes mellitus during long-term follow-up.~      Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or~     DP-EES implantation were included in a multicenter registry between January 2007 and May~     2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using~     propensity score matching. The pre-specified primary endpoint is the occurrence of major~     cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI)~     or target-vessel revascularization (TVR). Secondary endpoints are the individual components~     of the primary endpoint as well as definite stent thrombosis (ST).~   "
15499|NCT02854410|"~     The purpose of this study is to evaluate whether dietary nitrate supplementation could~     improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent~     chemo-radiation therapy.~   "
15500|NCT02854397|"~     In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema~     (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker~     for acute attack of bradykinin-mediated angioedema to help clinicians for patient care.~     However, previous works are carried out for that purpose. All the potential candidate~     biomarkers must be validated in prospective studies to estimate their specificity and~     sensitivity values, and to understand their potential utility in patient care.~      The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in~     pediatric population, for the differential diagnosis between HAE crisis and angioedema~     resulting of mast cell activation crisis (the main differential diagnosis of HAE).~   "
15501|NCT02854384|"~     This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the~     functions of the central nervous system (CNS) in epileptic patients.~   "
15502|NCT02854371|"~     Liver function is a key factor that can help predict the clinical outcome in patients with~     cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG)~     or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function~     in several studies. There have been several approaches to measure liver function using~     gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic~     acid enhanced liver MRI is clinically used world widely, it would be valuable if we can~     measure liver function using hepatocyte fraction.~   "
15503|NCT02854358|"~     Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of~     the most common side effect of radiation therapy among patients with HNC. Mouth dryness~     significantly impairs patients' quality of life (QOL).~      HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their~     beneficial effects in recent studies, we decided to design a randomized, controlled clinical~     trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation~     induced xerostomia~   "
15504|NCT02854345|"~     The goal of this study is to assess the performance of parathyroid imaging on a~     cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for~     primary hyperparathyroidism.~   "
15516|NCT02854189|"~     The purpose of this study is to explore the effects of the Oxford unicompartmental knee~     arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure~     and one without. Specifically, this study compare the number of occurrences of postoperative~     genu recurvatum and the postoperative hyperextension angles among the patients.~     Additionally, the knee scores, the pain scores, and the functional scores for the two groups~     of patients are compared.~      Materials and methods: This study prospectively followed 104 patients (114 knees) who had~     been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and~     had had a minimum of 24 months of follow-up. The patients were divided into two groups:~     those without preoperative genu recurvatum (85 patients; 94 knees) and those with~     preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative~     genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores,~     and the functional scores were recorded and compared between two groups..~   "
15505|NCT02854332|"~     Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more~     than 58 % for patients that carry a lesion of the spinal cord. This pathological condition~     stays a major health problem, particularly as the efficacity of available treatments is~     currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by~     a pharmacological approach.~      In case of failure, drug treatments or in addition of these ones, stimulation of the motor~     cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that~     found its place for neuropathic drug-resistant pain management only since a decade.~     Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are~     still little understood. This stimulation can be realised in a chronic and invasive way with~     implanted electrodes. This process allow a lasting relief for about half of operated~     persons, without the possibility to identify clinical selection criterion reliable for~     potentially responding patients for this technique.~      Recently, two electrophysiological non invasive techniques have been developed, allowing to~     get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic~     stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).~      The main goal of this study is to compare the importance of analgesic effect of tDCS in~     chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of~     stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already~     validated by data of the literature.~   "
15506|NCT02854319|"~     The objective of the REPRISE EDGE study is to confirm the acute performance and safety of~     the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for~     transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific~     aortic stenosis who are considered high risk for surgical valve replacement.~   "
15507|NCT02854306|"~     Mindfulness is a common practice already widely used, that has shown benefits in terms of~     psychological and physical health. It is about learning or learn again to be self present~     and aware to the environment, across breathing, sensations, emotions and thought centering~     exercises, in the present moment without any judgement.~      The goal is to evaluate the efficacy of mindfulness versus an active control group in~     bariatric surgery.~   "
15508|NCT02854293|"~     Prospective, randomized, multicentre phase III study to evaluate the level and type of~     information requested by patients or families during a palliative care consultation after~     they have been given the Booklet-Question List (BQL).~   "
15509|NCT02854280|"~     Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF),~     the modification of one or the other can affect the neuronal O2 availability.~      Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in~     state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and~     therefore of the CBF, can create an important dizziness between the demand and the supply of~     cerebral O2.~      It seems that hypoxia can trouble in a significant way the response of central neurons, just~     as the production of a motor cortex generated motor command.~      Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat~     for brain oxygenation and the motor command, with the consequence a decrease of the exercise~     performance.~      This projects aim to study effects of hypoxia on the brain function for patients suffering~     from chronic respiratory disease. Neurophysiologic responses of the brain while resting or~     exercising, including drip and cerebral oxygenation, cortical excitation and motor command~     resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz~     in blood.~      The study will use a multidisciplinary and supplementary methodological approach : the~     near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF,~     neurostimulation procedures and electromyography (EMG) to appreciate the cortical~     excitability, measure the level of central activation and motor command.~      The goals of this study will be :~        -  Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of~          voluntary activation and central fatigue to the effort for the chronic hypoxemic~          patient compared to healthy control subjects.~        -  Analyse disruptions of locomotion parameters and posturographyc, in simple and double~          task, involving different levels of cerebral task.~        -  Analyse acute effects of an improvement of arterial oxygenation for patients suffering~          from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation,~          cortical excitability, mechanisms of voluntary activation and central fatigue.~        -  Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for~          patients suffering from obstructive sleep apnea (OSA) with the same parameters.~   "
15510|NCT02854267|"~     A dedicated guide for physicians and organ procurement nurses meeting with the next of kin~     could be associated with a reduction in organ donation refusal rate, and in anxiety of~     professionals involved in such meetings~   "
15511|NCT02854254|"~     In decompensation of heart failure, it may occur low cardiac output. For patients in this~     situation, the use of inotropic may be necessary. Prolonged intravenous infusion of~     inotropic agents can lead to phlebitis in peripherally venous access. On the other hand,~     central venous access presents complications inherent in the procedure. The peripherally~     inserted central catheter (PICC) may be an option in this situation. The present research~     project is a randomized clinical trial to evaluate the incidence of phlebitis by using the~     PICC in comparison to the peripheral venous access. The criteria for inclusion are: advanced~     congestive heart failure, in use of intravenous inotropic; platelets > 50.000 mm3 and left~     ventricular ejection fraction (LVEF) < 0.45. Patients will be randomized to receive the PICC~     or keep the peripheral venous access. The main outcome will be the occurrence of phlebitis.~     The sample size will be of 40 patients for each group (PICC and control). The data will be~     analyzed by logistic regression. Will be considered significant P 0.05.~   "
15512|NCT02854241|"~     The purpose of this study is to investigate clinical feasibility of annual non-contrast~     magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group,~     in comparison with biannual ultrasonography.~   "
15513|NCT02854228|"~     The purpose of this study is to observe predictors of pituitary tumor recurrence and markers~     of persistent disease activity through computerized collection of comprehensive demographic,~     therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions~     of all types.~   "
15514|NCT02854215|"~     The purpose of this study is to investigate the medico-economic impact of adherence to INCa~     (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in~     cost per Quality Adjusted Life Years (QALY).~   "
15515|NCT02854202|"~     The investigators hypothesis is that eating whey protein in breakfast will reduce overall~     postprandial glycemia in individuals with type 2 diabetes (T2D).~   "
15528|NCT02854033|"~     Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging~     Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.~     ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been~     combined public/private collaborations between academia and industry to determine the~     relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker~     characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the~     study is to continue to discover, optimize, standardize, and validate clinical trial~     measures and biomarkers used in AD research.~   "
15517|NCT02854176|"~     Worldwide, 9.6% of men and 18% of women aged over 60 years suffer from osteoarthritis (OA),~     most of which involve the knee. Within the OA patient population, 80% of the OA patients~     have limitations of movement, and 25% cannot perform the majority of their daily activities~     (WHO). Some of these symptoms contribute to arthrogenic muscle inhibition (AMI), a reflexive~     decrease in motor output to the muscles surrounding the affected joint.~      AMI is characterized by abnormal afferent information transmitted to the central nervous~     system, resulting in altered afferent feedback to the quadriceps motoneurons (MN) which in~     turn results in reduced excitability of that particular pool. The altered afferent input is~     suggested to stem from stimulation of mechanoreceptors, via joint effusion or excessive~     movements, nociceptors as a response to pain, or loss of joint receptors (Palmieri-Smith et~     al., 2009). Although the evidence concerning the role of the central nervous system is~     scarce, pre- and postsynaptic spinal mechanisms directly affecting alpha-MNs seem affected.~     Dysfunction of γ-loops also seems to be involved (Konishi et al., 2002). These mechanisms~     together result in AMI that manifests through aberrations in voluntary quadriceps torque,~     force control, and reflex excitability often measured by the H-reflex (Hopkins et al.,~     2000).~      Besides the evident role of motor efferents, sensory afferents also influence motor control~     (Gentilucci et al., 1997) and poor proprioceptive function is predictive of poor chair-stand~     performance (Sharma et al., 2003). Reduction of the sensory deficits could potentially~     increase motor function in knee OA. The present study aims to evaluate whether low-intensity~     peripheral electrical nerve stimulation, a form of increasing afferent input, could~     potentially improve OA patients' motor function. The most limiting factor in OA patients,~     however, is pain, experienced at rest and during movement. Although previous paradigms used~     high-frequency stimulation and the lack of physiological explanations concerning pain~     reductions after peripheral electrical nerve stimulation, it is possible that reductions in~     experienced pain are mediated by reduced analgesia, i.e., decreased excitability of~     nociceptive neurons.~   "
15518|NCT02854163|"~     The investigators propose an open label pragmatic clinical and laboratory study designed to~     investigate, in detail, the clinical and molecular effects of Interleukin 17 (IL-17) and~     inhibition of IL-17 with secukinumab, on neutrophil function in vitro and ex vivo.~      As secondary, exploratory objectives, the investigators will utilise the fact that~     secukinumab is to be administering to 20 patients with Psoriatic Arthritis (PsA) and~     investigate whether there is any relationship between vitamin D status and response to~     secukinumab, with respect to efficacy and adverse events. The results of this secondary~     exploratory analysis will inform the design of a larger, definitive study.~   "
15519|NCT02854150|"~     The main objective is to improve genetic counseling in patients with Spina Bifida, by the~     characterization of variants in new genes using high throughput sequencing either on a panel~     of targeted genes or on exome in families.~   "
15520|NCT02854137|"~     Evaluation of the human eye irritation potential of a test sunscreen formulation.~   "
15521|NCT02854124|"~     The objective of this project is to evaluate the presence of melanoma quiescent or~     initiating clonal cells in peritumoral healthy tissue displaying the same molecular~     signature than those of the tumor/metastasis and to correlate this presence to the~     prognostic value.~   "
15522|NCT02854111|"~     The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the~     latest Thai National Health Examination Survey, an estimated 3.2 million people had DM, of~     whom one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more~     sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is~     recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT~     provides useful diagnostic information, poor patient tolerance of glucose solutions is~     inevitable.~   "
15523|NCT02854098|"~     Benign Hypermobility Joint Syndrome is a group of inherited abnormalities in the structure~     of connective tissues, manifested by disturbances in the proportion of collagen. The main~     symptoms of this syndrome include: laxity of joint capsules and ligaments, hypermobility of~     the joints, as well as numerous disturbances in the functioning of internal organs that~     contain connective tissue, including the gastrointestinal tract. Hypermobility of joints~     affects approximately 10% of the population of Western countries, is more common in small~     children and female. Modified Beighton scale is the basic scale for assessing hypermobility~     of joints. The scale (as assessed using the goniometer) is a reliable tool for the~     evaluation of excessive laxity of the connective tissue in children.~      Functional constipation is a very common condition, affecting approximately 3-5% of children~     and adolescents, with peak onset between 2 and 4 years of age. The etiology of this disorder~     is multifactorial, and till day it is still exactly unknown why some children develop~     constipation, while in others we can observe the correct scheme of defecation. Suspending~     stool enhances the retention of fecal masses, which subsequently causes painful defecation.~     Diagnosis is based on history, clinical symptoms and physical examination. Increased~     susceptibility of the wall of the distal gastrointestinal tract could explain the~     predisposition of some children to retain fecal masses and the development of constipation.~      Due to the unclear etiology of functional constipation, it seems reasonable to conduct a~     study assessing whether excessive laxity of connective tissue (assessed on the basis of the~     hypermobility of the joints) facilitates the accumulation of stool in the large intestine,~     and so is the one of the reasons leading to development of functional constipation in~     children.~   "
15524|NCT02854085|"~     The objective of this study is to determine the impact of Art Therapy and Music Reminiscence~     Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V:~     Mild Neurocognitive Disorder) using a randomized control design.~      Specifically, the structural cerebral changes that occur with the two interventions and the~     extent to which the therapies may reverse cognitive impairment and/or prevent further~     cognitive decline, will be determined.~      The hypothesis is that participants in both active intervention arms will perform better on~     neuropsychological tests of cognition and will show positive changes on functional imaging~     studies compared to controls who will not receive any intervention. Participants in the~     interventions will also have positive changes in blood biomarkers, enhanced psychological~     well-being and reductions in anxiety and depressive symptoms compared to the control group.~     No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence~     Activity is more effective as the comparison is exploratory.~   "
15525|NCT02854072|"~     To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus~     Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer~     patients.~   "
15526|NCT02854059|"~     The main purpose of this study is to evaluate safety and tolerability in patients diagnosed~     with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single~     intravenous dose of IdeS.~   "
15527|NCT02854046|"~     Calciphylaxis, also called Calcific Uremic Arteriolopathy (CUA) is a lethal affection mostly~     affecting patient in end stage renal disease. The survival rate is described around 20 to~     46% at one year.~      Clinical presentation is very painful skin lesions with ulceration mostly located on the~     trunk or thigh.~      Current knowledge about physiopathology, diagnostic practice and therapeutic is very~     limited.~      Actually there is no European study about calciphylaxis and risk factors, diagnostic~     practice and outcome factors.~   "
15529|NCT02854020|"~     Since the number of air travelers, including the elderly and passengers with an underlying~     disease, is increasing every year, the number of inflight emergency patients is expected to~     increase as well. The investigators attempted to identify the incidence and types of~     inflight medical emergencies and analyze the first aid performed by cabin crew members or~     medical volunteers in flights by an Asian airline. The investigators also investigated the~     causes of inflight deaths and aircraft diversions.~   "
15534|NCT02853955|"~     Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and~     effective alternative treatment option for selected patients at high risk for cardiac~     surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair~     (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this~     multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to~     evaluate the effectiveness and durability of this minimally invasive treatment option in~     this subset of patients.~   "
15535|NCT02853942|"~     Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous~     adipose stem cell transplantation in the treatment of makes the acceptance micro vascular~     decompression hemifacial spasm patients to nerve function to obtain a better recovery.~      Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve~     dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.~      Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm~     to decrease neural electrophysiological index of patients research design：Single center,~     prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical~     score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal~     fluid index Evaluation of therapeutic effect：Facial nerve function evaluation~     (House-Brackmann classification, facial nerve function classification scale SFGS), facial~     nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric~     measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular~     decompression were listening to nerve in intracranial segment wrapped around the autologous~     fat stem cell therapy overall safety and evaluation methods including adverse events,~     laboratory tests, vital signs, electrocardiogram.~   "
15536|NCT02853929|"~     The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa~     booster dose given at 12-18 months of age to infants who received primary vaccination at~     6-12 weeks. All infants in this booster study were born to pregnant women who participated~     in the study 116945 [DTPA (BOOSTRIX)-047].~   "
15537|NCT02853916|"~     The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and~     explore dose-response relationship by comparing two different doses.~      The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood~     glucose.~   "
15538|NCT02853903|"~     The aim of this study is the efficacy of autogenic and allogenic natural killer (NK)~     immunotherapy on recurrent solid tumors.~   "
15539|NCT02853890|"~     Obstetric analgesia is a requirement of our times. The different applicable methods vary in~     effectiveness. The essential part is represented by epidural analgesia which remains one of~     the most effective methods. It is important to know other methods to respond to all~     requests. The applications of these methods, patient satisfaction and psychic experience,~     complications or incidents remain poorly or partially evaluated in France.~      The main objective is to describe the different techniques of anesthesia/analgesia actually~     used in France for the management of pain during vaginal deliveries and cesarean sections on~     a representative sample of all maternity hospitals at a given time(7 days per maternity~     hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).~      Secondary objectives will be multiple :~        -  Describe the results of analgesic methods on the physical pain of patients during labor~          by a global visual analog scale~        -  Describe the feeling of pregnant women relative to the different anesthesic and~          analgesic techniques, by an analysis of the questionnaire responses~        -  Describe the frequency of adverse events of birth~   "
15540|NCT02853877|"~     This study will evaluate the effectiveness of financial incentives and messaging tailored to~     individual goals and aspirations to promote and sustain weight loss. This is a 2-arm~     randomized controlled trial that will recruit eligible employees at a large university to~     participate in a 3-month weight loss program, followed by a 3-month follow-up period. The~     primary outcome will be change in autonomous motivation for weight loss.~      The study hypothesis is that intervention group participants will have a greater increase in~     autonomous motivation for weight loss than participants in the control group at 12 weeks.~   "
15541|NCT02853864|"~     The purpose of this study is to determine the effect of gender on pharmacodynamic~     interaction of propofol and dexmedetomidine, exploring the effect of gender on propofol~     unconsciousness median effective concentration with different dose dexmedetomidine.~   "
15542|NCT02853851|"~     This study aims to construct and validate an international professional perceived stress~     scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive~     Care Units).~   "
15543|NCT02853838|"~     The purpose of this research is to determine the effect of prolonged slow expiration~     techniques, provoked coughing and standard therapy compared to chest wall manual vibration~     and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of~     acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and~     use of supplementary oxygen.~   "
15544|NCT02853825|"~     Every program element was designed to ensure that all children in the areas served will live~     in stable, happy, healthy family situations. The JFCS Healthy Families/Healthy Children~     program will provide relationship skill enhancement interventions. All program participants~     in the intervention group will have acces to: parenting skill enhancement interventions,~     employment readiness and/or situation enhancement, as well as financial knowledge and/or~     situation enhancement.~   "
15545|NCT02853812|"~     The proposed research is to identify the brain areas activated or deactivated by tinnitus in~     humans. The identification of these areas is expected to be able to treat tinnitus~     refractory to traditional therapies by methods of brain stimulation. Furthermore, this~     technique would be very useful to verify the effectiveness of any treatment to relieve~     tinnitus.~      The brain activation measured during fMRI will be performed in a position of rest, after~     inhibition of tinnitus, and after application of a sound that does not inhibit tinnitus.~     This comparison will identify specific brain areas activated or deactivated by tinnitus.~   "
15571|NCT02853474|"~     This prospective, randomized, open-label and multicenter phase III study is aimed to~     estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology~     care including first-line chemotherapy (experimental arm) over standard oncology care only~     (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer,~     pancreatic cancer, biliary tract cancers).~   "
15546|NCT02853799|"~     Continuous enteral feeding is the most common type of nutrition used in critically ill~     patients despite being non-physiologic, as all mammalian alimentary tracts have been~     designed for intermittent ingestion of nutrients. The small numbers of randomized controlled~     studies that have compared intermittent gastric feeds (IGF) to continuous gastric feeds~     (CGF) in intensive care units have demonstrated that IGF is safe, feasible and have the~     shorter time to goal nutrition. Studies of healthy adults have also demonstrated that the~     mean glucose concentration (MGC) is lowered when bolus enteral feedings are used instead of~     continuous feeds; these changes in glucose-insulin metrics might be beneficial to a~     critically ill patient population where stress hyperglycemia is common. This study will~     compare the effects of CGF and IGF in a critically ill medical patient population.~     Glucose-insulin dynamics for each type of enteral feed will be analyzed by performing a~     randomized crossover study to compare the effects of CGF and IGF on MGC, total insulin~     infused, glucose variability (GV), episodes of hypoglycemia and maximum glucose~     concentration values.~   "
15547|NCT02853786|"~     The Language Environment Analysis (LENA) system is a specific tool for the language~     environment analysis. Children aged from 18 months to 6 years old, with cochlear implants~     (CIs), wear an electronic device during a day and their language interactions are~     registered. Then the investigators can analyze with a specific software four different~     parameters (adult words, conversational turns, child vocalizations and media exposure) and~     compare them to the language ability of the children assessed by a speech therapist. With~     the results, the speech therapist can advise the parents how to improve the language~     environment to help their children with CIs for their language development. Parents are~     encouraged to follow these advices at home during few months (5 months +/-1 month). Then~     there is a new registration of the LENA device and another language assessment are~     performed, to see if there is any improvement. The investigators also measure the family~     participation.~      Hypothesis : There is an influence of the language environment measured by the LENA system~     on language development in children with cochlear implants.~   "
15548|NCT02853773|"~     This study aims at investigating the acute influence of artificially sweetened beverages~     consumption (as compared with sugar-sweetened beverages and water consumption) on brain~     responses to the viewing of food images, on physiological responses (gut-derived hormones~     and lipid metabolites) and on the food intake behavior.~   "
15549|NCT02853760|"~     Using a within-subject design, 42 healthy participants were randomly exposed to three~     different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary~     control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale~     and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the~     conditions.~   "
15550|NCT02853747|"~     The project is designed as a large scale, cross-sectional study. The aim of the study is to~     investigate the association of micro- and macrovascular function with physical fitness and~     body composition in primary school children.~   "
15551|NCT02853734|"~     The research aims to compare the inflammatory status of visceral adipose tissue from obese~     patients depending on the presence and severity of periodontitis, in order to establish a~     potential causal link between the severity of the bacterial contamination and insulin~     resistance.~   "
15552|NCT02853721|"~     150 patients divided into two groups.The experimental group was submitted at the assay of~     iPTH six hours after surgery whilst the control group was submitted to a daily assay of~     serum calcium and phosphorus.~   "
15553|NCT02853708|"~     The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic~     Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that~     produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the~     epidemiology of ESBL producing ST131clonal group in our university hospital. All patients~     with an infection due to ESBL E. coli will be prospectively included for a 2-year period.~     ST131 isolates will be identified and risk factors associated to ST131 will be determined in~     comparison to non-ST131 ESBL E. coli.~   "
15554|NCT02853695|"~     By means of a questionnaire the investigators will study the implementation of hysteroscopy~     in Flanders and the Netherlands~   "
15555|NCT02853682|"~     The glycocalyx is a layer of proteins and complex sugars covering the endothelium of~     vessels. Its role as capillary filtration control is important. In case of alteration of the~     glycocalyx, experimental models and some clinical studies show an increased capillary leak~     responsible for interstitial edema. The analysis of glycocalyx in routine care is important~     to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis~     of excess water and its impact on organ. This analysis challenge is to justify filling~     solution of choice according to the characteristic of this capillary leakage.~   "
15556|NCT02853669|"~     Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory~     nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain~     management with less motor affection. Also, it has a clear anatomical landmark that will~     increase the success rate (femoral artery) (*).On the other hand, being a branch of the~     femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness.~     Likewise, the great variation of the knee nerve supply.~      This prospective double-blinded randomized controlled trial is comparing ultrasound guided~     adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients~     undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in~     early mobilization and better physiotherapy.~      This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness,~     fewer opioids consumption with the same or better pain score.~   "
15557|NCT02853656|"~     Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of~     pregnancies; preterm birth can lead to complications for the baby.~      When mothers are identified as being at risk of going into preterm birth (giving birth~     within the next 14 days) there are several treatments available that may help reduce the~     likelihood of complications for the baby. These treatments usually need to be started within~     24 hours so it is very important that diagnosing preterm labour in not only fast but~     accurate.~      There are several methods commonly used within hospitals for diagnosing mothers who may be~     at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN)~     and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).~      The purpose of this study is to compare the two tests to see which is more accurate at~     predicting preterm birth.~   "
15559|NCT02853630|"~     This study is a multicentre, randomized, open label on comparison of pancreatic beta cell~     recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily~     for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in~     Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus~     Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin~     secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes~     will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in~     terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction~     in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement~     in insulin sensitivity, Improvement in oral disposition index, Percentage of patients~     reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study~     population and General safety in terms of occurrence of adverse events~   "
15560|NCT02853617|"~     AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone~     of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed~     on the surface of a wide array of microbes.~      AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety~     of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a~     single U.S. center, based on 4 subjects per dose group. The study will consist of 2 parts:~     Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a~     second dose of AV0328.~   "
15561|NCT02853604|"~     High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent~     chemotherapy and radiation therapy. This is a group of patients with a significant unmet~     need. The estimated probability of disease recurrence or death within 4 years of diagnosis~     is 50% and the prognosis is very grave for those who experience a recurrence.~      The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to~     placebo administered following CCRT with curative intent in subjects with HRLACC.~   "
15562|NCT02853591|"~     This study seeks to evaluate post-operative patient pain and quality of life, and~     intra-operative hemodynamic status and changes in inflammatory markers, with use of a~     pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum~     pressure settings.~   "
15563|NCT02853578|"~     National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants~     of both sexes, aged equal or more than 12 and less than 65 years. The group will use~     Busonid® (budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12~     hours (400mcg / day). During follow-up visits if the participant has not shown an increase~     in forced expiratory volume in one second greater than 12% and greater than 0,20L or 200ml~     in spirometry compared with baseline visit, will increase the dose to 800 mcg / day (2x 400~     mcg day).~      The study aims to revalidate by the National Health Surveillance Agency (ANVISA) the~     registration of the drug Busonid® which there is a vast scientific literature on the~     pre-clinical and clinical evidence that the efficacy and safety of budesonide. Thus,~     outlined is a single-arm study, which is applied to the study of the group of participants~     the same intervention for a certain period and the participants are evaluated for response.~   "
15564|NCT02853565|"~     To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when~     administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in~     Patients with Newly Diagnosed Glioblastoma Multiforme.~   "
15565|NCT02853552|"~     The overall study purpose is to evaluate the safety, feasibility and acceptability of~     advance distribution of misoprostol to be used as 'first aid treatment' administered by the~     woman herself or her family to help treat excessive bleeding in home births.~   "
15566|NCT02853539|"~     Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral~     nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim~     of the study was to assess its value in chronic intestinal failure patients.~   "
15567|NCT02853526|"~     To date, there is no treatment strategies for these patients according to American~     Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V~     consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative~     treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in~     patients with PVT and CPTV.~   "
15568|NCT02853513|"~     The scientific approach of this project proposes to build a cohort of psychological~     injuries post-attack of 13 November 2015. This is called patients involved, ie patients~     who directly witnessed the events and having the most either came under automatic gunfire or~     were close to an explosion, whether or not physically injured.~      The main objective is to define and validate a model of transition from acute stress~     disorder (ASD) to posttraumatic stress disorder (PTSD) for better detection of the risk of~     unfavorable and thus better patient supported.~      The first step is to determine independent risk factors found in analytic prospective cohort~     study.~      Bayesian models are well suited to exercise because they can integrate (i) the context~     related to the patient, (ii) the context related to the trauma itself, and (iii) the~     immediate reactions and long-term to the latter . They are particularly suited to~     understanding the brain disordered by saying down information (prior probability) wrong by~     improper memory of the traumatic event. The confrontation of these descending information~     and perceived bottom-information could be partly responsible for the symptoms of PTSD.~      Once validated, the model will characterize the individual level the most at risk of~     unfavorable patients (calculating a probability of developing PTSD) and to assess the~     epidemiological impact on long-term cohort of event considered.~      These determinations are necessary prerequisites to optimize the means of support for these~     current and future casualties.~      The investigators main objective is to define a Bayesian model describing a resilient~     functioning facing a trauma which also allows to describe a possible evolution of the ASD to~     PTSD by an error.~      The state of PTSD or not will be determined by the PCL-S scale.~   "
15569|NCT02853500|"~     This research study is studying the Surefire Infusion System (Surefire) for increasing~     delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage~     Hepatocellular Carcinoma (HCC) (Barcelona Clinic Liver Cancer (BCLC) class B; locally~     advanced, liver restricted disease patients.~      The names of the study interventions involved in this study are:~      -Trans-arterial chemoembolization (TACE) with or without the utilization of Surefire~   "
15570|NCT02853487|"~     The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.~   "
15572|NCT02853461|"~     In this study the investigators sonicate the bearing components of the explanted hip~     prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and~     quantitatively). The hip prosthesis bearing components are composed from different material.~     The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic,~     metal and polyethylene prosthesis components through microbiologic analysis of sonicates.~   "
15573|NCT02853448|"~     There are many instances where there is no access to a centrifuge (Emergency wards, EMT~     truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a~     new collection tube which could separate serum and plasma from whole blood immediately upon,~     if not during, collection, would be extremely beneficial. Such a new tube could save time~     and cost by eliminating centrifugation steps that are currently required to obtain serum and~     plasma.~   "
15574|NCT02853435|"~     This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,~     tolerability, and relative bioavailability of the 2 free base tablet formulations (related~     compound [RC] and high shear wet granulation [HSWG]) compared to the reference capsule~     formulation under fasted conditions. This is a 3-period; cross-over study that will guide~     which gepotidacin formulation will be used for future studies. Following review of~     pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed~     with Parts 1b and 2.~      Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the~     selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected~     gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will~     be evaluated under fasted conditions.~      The duration of the study (from Screening to the Follow-up visit) will be approximately 44~     days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The~     approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3~     treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12~     Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.~   "
15575|NCT02853422|"~     The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical~     and therapeutic decisions.~   "
15576|NCT02853409|"~     The purpose of this study is to evaluate possible changes in quality of life related to~     health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of~     follow-up.~   "
15577|NCT02853396|"~     Stigma is a significant concern for those who experience psychosis. People with psychosis~     are the most stigmatised group of all mental health difficulties. There is a lack of~     research examining the effectiveness of psychological therapies for people who experience~     psychosis who are also experiencing negative impacts of stigma. To date, all studies~     examining stigma therapies have been conducted with outpatients and no support have been~     developed for inpatients. The aim of this study to conduct a pilot randomised controlled~     trial of a brief therapy (based on cognitive behavioural therapy)to help participants cope~     with stigma. It will be compared to a educational control intervention. Both therapies will~     last approximately two hours and be conducted in one or two sessions by the principal~     investigator (clinical psychologist). Participants will be given a number of questionnaires~     assessing a number of outcomes such as impacts of stigma, depression, recovery, and~     self-esteem. Participants will be assessed on these measure prior to the therapy, post~     therapy and at follow-up.~   "
15578|NCT02853383|"~     The purpose of this study is to determine COPD prevalence among patients registered in the~     healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of~     Moscow).~      To describe the clinical profile of COPD patient who is under outpatient surveillance at~     polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity,~     occupation), smoking status, disease duration, disease severity grade, distribution by~     disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).~   "
15579|NCT02853370|"~     Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered~     as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and~     represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of~     differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an~     almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the~     disease pursues an aggressive course and most patients die of lymphoma progression within~     3-4 years.~      Retrospective studies have indicated that purine analogous achieved very high response rates~     in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of~     differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in~     combination with chemotherapy has been reported to be very effective in producing a rapid~     clearance of neoplastic cells.~   "
15580|NCT02853357|"~     The purpose of this study is to determine the short-term effects of thoracic spine thrust~     manipulation on participants with low back pain. Participants in this study will be~     randomized to receive either the lower thoracic spinal manipulation and a standard set of~     exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized~     that thoracic manipulation when combined with core strengthening exercises will have~     positive short term improvements in pain and function for patients with LBP as compared to a~     sham manipulation combined with core strengthening exercises.~   "
15581|NCT02853344|"~     The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab~     (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this~     study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will~     consist of participants with non-clear cell (ncc) RCC.~   "
15582|NCT02853331|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)~     in combination with axitinib versus sunitinib monotherapy as a first-line treatment for~     participants with advanced/metastatic renal cell carcinoma (mRCC).~      The primary hypotheses of this study are: 1) The combination therapy of pembrolizumab plus~     axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival~     (PFS) as assessed by blinded independent central imaging review per Response Evaluation~     Criteria in Solid Tumors version 1.1 (RECIST 1.1) and 2) the combination therapy of~     pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall~     Survival (OS).~   "
17035|NCT02834364|"~     Trial for patients with refractory multiple myeloma after failure of at least two treatment~     regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors~     Encorafenib (LGX818 in) combination with Binimetinib (MEK162).~   "
15583|NCT02853318|"~     This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral~     cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary~     peritoneal cancer. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may block~     tumor growth in different ways such as boosting your own immune system to find, recognize~     and kill tumor cells as well as by blocking the growth of new blood vessels necessary for~     tumor growth and nutrition. Drugs used in chemotherapy, such as low dose oral~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, as well as by further enhancing your own body's immune response against~     cancer cells. As these three drugs have all been shown to improve the immune response~     against cancer cells giving pembrolizumab, bevacizumab, and cyclophosphamide together may~     work better in treating patients with recurrent ovarian, fallopian tube, or primary~     peritoneal cancer.~   "
15584|NCT02853305|"~     The purpose of this study is to determine the efficacy and safety of pembrolizumab (MK-3475)~     with or without chemotherapy versus chemotherapy alone in participants with advanced or~     metastatic urothelial carcinoma (bladder cancer).~      The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy~     alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in~     participants with programmed cell death ligand 1 (PD-L1) positive tumors and in all~     participants (includes those participants with PD-L1 positive tumors and those with PD-L1~     negative tumors).~   "
15585|NCT02853292|"~     Intravenous high-dose amoxicillin is a frequently prescribed antibiotic in intensive care~     units and infectious disease departments, in such indications as meningitis, endocarditis,~     listeriosis, or documented susceptible osteo-articular infections.~      Among possible side effects is the occurrence of amoxicillin crystalluria. Its incidence is~     unknown. It is deemed uncommon but literature is poor and its incidence is probably~     under-estimated. It can be complicated with hematuria or acute renal failure and may require~     renal replacement therapy. measures that can limit the impact of this nephrology~     crystalluria.~      Since the beginning of 2014, because of the occurrence of a case of macroscopic crystalluria~     in our unit and a pharmacovigilance alert, it has been decided to search systematically for~     amoxicillin crystalluria in several centers of the north-east of France. The investigators~     propose to study these patients, through an observational study of a multicenter~     longitudinal cohort, to assess the incidence of amoxicillin crystalluria during high dose~     intravenous amoxicillin treatment.~   "
15586|NCT02853279|"~     One hundred participants from a combination of (a) local advertisements and/or (b) those~     whose details are held on a research database (of previous volunteers indicating willingness~     to be contacted about future studies) will be sought to volunteer for this study. Written~     informed consent will be gained following greater than 48 hours for the purpose of reading~     the Participant Information sheets. The study will then involve two stages (i) recruiting~     participants for a cross sectional analysis of the relationship between physical activity~     levels and cardiovascular and cognitive function, and (ii) a longer exercise training study~     in a subsample of these volunteers (i.e. participants who volunteer to exercise train).~     Participants for stage 1 will then visit the laboratory in the University on three occasions~     (over a three week period) to be assessed for body composition, exercise tolerance, current~     physical activity levels, cognitive function and arterial and cardiac health. Each visit~     will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to~     wear for a period of one week in order to assess movement counts and sedentary behaviour.~     Stage 2 will include only those participants who have volunteered for the exercise training~     component (approx 60). These participants will then be randomly divided into two groups.~     Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise~     in a traditional manner at a moderate intensity, whilst the second group will exercise at a~     heavy intensity but in short bursts. Both groups will complete the same amount of work but~     in two differing modes. Both groups will attend the laboratory twice per week for supervised~     exercise sessions and also perform one home based 30 minute brisk walk per week. All~     participants will be re-examined at 12 weeks.~   "
15587|NCT02853266|"~     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has~     been reported worldwide, but it is ten times more common in Asian population. It is the~     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80%~     of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~      KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder.~     The problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the~     heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance~     with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral.~      There is currently no vaccine available against Kawasaki disease so it is extremely~     important to be able to recognize symptoms before they set in and become too severe.~      Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately~     after infection, may last up to a few weeks or months. Infection may be mild or~     asymptomatic. There may be fever or swelling around the site of inoculation, and acute~     infection may result in severe inflammation of the heart muscle. The notion that the~     pathology of CD has an autoimmune component was initially based on the finding of~     circulating antibodies binding heart tissue antigens in patients chronically infected with~     T. cruzi.~      A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry~     characterized by a serological reactivity to a well-defined T. cruzi antigen in blood~     samples from individuals not exposed to the parasite. The measured seroprevalence of such~     cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood.~      There are similarities in mechanism of CD and KD: it could be interesting to explore the~     presence of NCRA in blood samples from adults with a history of KD.~      The objective of the study is the measurement of the biomarker NCRA in serum in adults with~     a history of KD compare to a control population. This measurement and the prevalence may~     permit to associate the NCRA to a possible pathogenic agent.~   "
15588|NCT02853253|"~     SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare~     the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants~     < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide®~     20%. This study will offer new information for optimizing the management of preterms~     requiring parenteral nutrition. The investigators hypothesis is that the composition of~     SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a~     lower incidence of BPD.~   "
15600|NCT02853097|"~     This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)~     in blood from patients with prostate cancer that does not respond to hormone therapy and has~     spread to other places in the body. Studying samples of blood from patients with prostate~     cancer may help doctors to learn more about the changes that occur in tumor cells over time~     and how they become resistant to anti-cancer drugs.~   "
15601|NCT02853084|"~     This is an open label, single arm trial to evaluate the efficacy, safety, and~     pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).~   "
15602|NCT02853071|"~     This study evaluates efficacy, safety and quality of life in patients affected by metastatic~     breast cancer RH+/ HER2- and treated by estramustine phosphate.~   "
15603|NCT02853058|"~     High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but~     also with stillbirth and distress during labor.~   "
15589|NCT02853240|"~     Cerebral palsy (CP) is a group of non-progressive motor dysfunction but often changing,~     secondary to injury or brain abnormalities that occur in early stages of development. In~     children with CP, the brain injury lead to a delayed motor development in the first weeks,~     associated with muscular spasticity. Drug treatments include oral treatments (baclofen and~     tizanidine) and injectable treatments like Botox (intramuscular injection) and neurolysis~     with alcohol or phenol (local injection into the nerve).~      Regarding botulinum toxin, there is no study questioning its effectiveness. However, no~     publication on the pathophysiology of human muscle of the CP child after toxin injection was~     found. The action of the toxin on the neuromuscular junction (NMJ) and muscle structure is~     unknown in children with CP.~      The primary objective of this study is to describe structural abnormalities of the CP~     child's muscle following multiple toxin injections in terms of NMJ fragmentation and axonal~     sprouting.~      Secondary objectives:~      To evaluate the relationship between:~        -  The severity of the motor impairment and muscle structural abnormalities.~        -  The clinical measure of spasticity and muscle structural abnormalities.~        -  To compare the structure spastic muscles with toxin injections and spastic muscle~          without toxin injections~      For muscles with multiple toxin injections, assessing the relationship between :~        -  The number of toxin injections and muscle structural abnormalities.~        -  The date of the first injection and muscle structural abnormalities.~        -  The total dose of injected toxin in the muscle and its structural abnormalities.~        -  The nature of the product injected in the muscle and its structural abnormalities.~      This innovative study will improve the knowledge on the effects of long-term botulinum toxin~     injections on the muscle (and therefore its safety in usual care), on the spastic muscle NMJ~     of CP children, on the pathophysiology of the CP child's muscle.~      All the visits all acts will be performed according to usual patient follow-up. Only a~     biopsy will be performed in addition, taken from an injected muscle during a planned~     operation. A biopsy may also be performed on a muscle without toxin injection if the act is~     made possible by the planned surgery. No biopsy will be made on a muscle that would not~     require surgery.~   "
15590|NCT02853227|"~     This paper will present a specific tool for evaluation of cosmetic results after breast~     conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap.~     Introduction of a breast score system using digital photography seems to be a reliable tool~     for estimation of cosmetic results after breast surgery. The method has been employed on a~     specific group of 346 consecutive patients operated for breast cancer with breast conserving~     surgery. For the purpose of this study breast score system was tested on patients with free~     flap breast reconstruction (DIEP flap).~   "
15591|NCT02853214|"~     Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma~     accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma~     commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined~     significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown~     and no lifestyle or environmental exposure factors have been identified that are~     consistently linked to increased risk of MM, MGUS or the transition between the two.~      The overall goal is to identify risk genes for dysglobulinemia, and more specifically~     Multiple Myeloma. This will involve the conservation of cells in a bank and genetic~     sequencing on samples obtained from families with at least two cases of dysglobulinemia.~     Material used for sequencing is likely to include fresh peripheral blood cells or~     lymphoblastoid lines established from peripheral blood lymphocytes of patients.~   "
15592|NCT02853201|"~     Mechanical ventilation is a life-saving treatment for critically ill patients who are unable~     to breathe on their own. At the time of recovery, separation from the ventilator is~     performed without difficulty for the majority of patients. However, approximately 15% of~     patients experience extubation failure, i.e. they are re-intubated after extubation within a~     period of 48 hours to 7 days. Patients who fail extubation are exposed to a longer duration~     of mechanical ventilation, higher rates of ventilator-acquired pneumonia, higher morbidity,~     and higher ICU mortality. Therefore, it is of relevant importance for clinicians to identify~     patients who are at risk of extubation failure as soon as ventilation has been discontinued.~     However, current clinical assessment has poor predictive performance: some physiological~     variables can be helpful but can only be obtained invasively using esophageal and gastric~     catheters.~      Using ultrasound measurements to assess the activity of the respiratory muscles could be of~     particular interest for this purpose. By showing an early recruitment of the accessory~     muscles as well as diaphragm dysfunction or hyperactivity, ultrasounds could help clinicians~     pay greater attention to such patients and therefore try to apply specific therapeutics.~     There are several advantages to ultrasounds: they are non-invasive, available in most~     intensive care units, and previous studies have reported reasonable reliability of the~     measurements.~      In the present study, we aim to assess the contractility of the respiratory muscles~     (diaphragm, intercostal, and sternocleidomastoid) using ultrasounds to identify patients who~     may be at risk of extubation failure and/or ICU readmission.~   "
15593|NCT02853188|"~     The aim of the study is to evaluate if the plasma activity of the tissue factor at the time~     of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction~     (surgery or two first cures of chemotherapy), can be a predictive factor of venous~     thromboembolism disease in the year which follows the diagnosis, independently of the other~     parameters.~   "
15594|NCT02853175|"~     In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic~     Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with~     cystic fibrosis.~   "
15595|NCT02853162|"~     Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation~     therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).~   "
15596|NCT02853149|"~     This study determines in people with chronic SCI the health and functional impact and user~     acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact~     and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI~     caregiver health and function and whether the complementary caregiver curriculum (CCC)~     enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the~     LI program.~   "
15597|NCT02853136|"~     To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306~   "
15598|NCT02853123|"~     The primary objective of the present study is to evaluate the effect of tiotropium +~     olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity~     of breathlessness during the 3min constant speed shuttle test (CSST).~      A secondary objective is to explore the relationship between reductions in breathlessness~     during the 3min CSST and reductions in breathlessness during activities of everyday living~     as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following~     bronchodilator therapy.~   "
15599|NCT02853110|"~     The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal~     SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with~     acceptable toxicity in addition to whole gland prostate SBRT.~   "
15616|NCT02852889|"~     The purpose of the study was to verify the efficacy of using internal jugular vein (IJV)~     size and distensibility as an index of fluid responsiveness in mechanically ventilated~     patients after cardiac surgery.~   "
15604|NCT02853045|"~     Despite a large diffusion for generic anti-hypertensive, they are not currently used.~      Clinical validation studies could be better to convince users and prescribers than~     pharmacologic validation only.~      A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place~     in real conditions of care for hypertensive patients, for a manometer control criteria.~      The aim of the study is to test the hypothesis of non-inferiority for generic~     anti-hypertensive for blood pressure control.~   "
15605|NCT02853032|"~     Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral~     prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a~     safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the~     large variability in the magnitude of clinical outcomes reported is likely related to the~     current lack of knowledge of ideal side of stimulation (left vs right) and the limited~     precision in the targeting of brain circuits needed to obtain an optimal treatment response.~     In this protocol the investigators will: 1) generate individualized treatment plans based on~     an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based~     connectivity analysis to guide the delivery of adjunct, imaging-based & robotically~     delivered rTMS to active duty military (ADM) subjects with PTSD participating in an~     intensive program providing integrated evidence-based psychotherapy and pharmacological~     management (Treatment as Usual (TAU)). 2) To use clinician ratings and self-report PTSD~     symptom scales, as well as other indicators of clinical change, to determine whether~     compared with TAU, addition of adjunct rTMS improves clinical outcomes. 3) To conduct~     neuroimaging-based assessments aimed to measure rTMS effects on network connectivity in ADM~     receiving treatment for PTSD and the potential correlation of connectivity changes with~     clinical outcomes.~   "
15606|NCT02853019|"~     Anhedonia and avolition reflect emotional and motivational disorders, respectively. However,~     if these disorders play a major role in the symptomatology of schizophrenia, their~     mechanisms remain poorly understood, and existing treatments are inefficient on these~     symptoms. The literature suggests that the impairment does not concern emotion or motivation~     per se, but rather their influence on cognition. This project aims at using recent advances~     in the fundamental domain to better understand the cognitive and neuronal mechanisms of the~     patients' alterations, and especially how emotion and motivation influence cognition in~     schizophrenia.~   "
15607|NCT02853006|"~     The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It~     requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).~      This study is about the set up of an innovative test for lung cancer prognosis, based on~     biopsies and surgical material : LungCancerTest, with the creation of a start-up in~     progress.~      The main goal of this study is to approve the diagnostic value of the molecular signature of~     the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with~     lung cancer.~   "
15608|NCT02852993|"~     Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC~     transfusion has proven its efficacy regarding mortality and morbidity, but it is not without~     side effects. The infectious side effects of transfusion are largely considered under~     control, non-infectious side effects are taking center stage. Seeking explanations for the~     beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and~     optimal use of this precious resource.~      The investigators aim to study the impact of donor and RBC characteristics on patient~     survival.~   "
15609|NCT02852980|"~     Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth~     in the Hospital center Rene Dubos and having gestational diabetes.~   "
15610|NCT02852967|"~     This study is being conducted to evaluate the safety, tolerability, and efficacy of KD025 in~     adult subjects with moderate to severe chronic plaque psoriasis.~   "
15611|NCT02852954|"~     Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be~     questionable whether tumor cells express PIBF for escape of immune system. There are some~     studies in the literature that evaluate PIBF expression of different malign cells (e.g.~     glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary~     brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has~     been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF~     expression of endometrial tumor cells. Therefore, the investigators aim to determine the~     PIBF expression levels in the endometrial cancer cells.~   "
15612|NCT02852941|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke~     Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a~     impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis.~     Ilmenau) in stable renal transplant recipients Nutritional status was measured by Tanita 418~     Monitor.~   "
15613|NCT02852928|"~     Generation of a common European database and biobank Continous assessment and implementation~     of guidelines and treatment protocols Establishment of a large observational cohort of chILD~     patients Determination the value of outcomes used in child Assess treatment variations used,~     deliver data from defined protocols and linked outcomes~   "
15614|NCT02852915|"~     The purpose of this study is to compare the short- and long-term survival of laparoscopic~     surgery and conventional open surgery for T4 colon cancer.~   "
15615|NCT02852902|"~     Main objective: to observationally assess the efficacy and safety of different~     antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacteriaceae in SOT.~      Secondary objectives:~        1. To evaluate the efficacy and safety of different antibiotics used for the treatment of~          infections caused by ESBL- and carbapenemase-producing Enterobacteriaceae in the SOT~          population.~        2. To compare the efficacy of different antimicrobials between SOT and non-SOT patients~          (using matched controls from the non-transplant INCREMENT cohort).~        3. To create a microbiological collection of ESBL- and carbapenemase-producing~          Enterobacteriaceae isolated from the SOT population.~        4. To provide data on specific MICs for each antimicrobial evaluated.~        5. To provide data on the prevalence of specific mechanisms of resistance and their~          clinical impact in the particular setting of SOT.~        6. To organise an international consortium capable of developing high quality prospective~          cohort studies and randomised clinical trials in the area of MDR and XDR~          Enterobacteriaceae in SOT.~   "
15624|NCT02852785|"~     The main purpose of this study is to characterize and compare the 3D shoulder kinematics~     bilaterally while performing functional movement patterns tests that hypothetically~     replicate the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for~     flexion (early and late cocking of the arm) and D2 for extension (acceleration, deceleration~     and follow-through of the arm) of the upper extremity of proprioceptive neuromuscular~     facilitation techniques.~   "
15625|NCT02852772|"~     Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment.~     Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably~     affecting the small vessels. In the older general population microalbuminuria is associated~     with greater annual cognitive decline and has been proposed as an easily and inexpensive~     measured marker predicting future cognitive function decline. Ageing of the PLH leads to an~     increase of cognitive disorders and chronic renal failure incidence and could imply a common~     underlying mechanism affecting the renal and cerebral microvasculature. In this setting the~     investigators undertake this prospective, cross-sectional, case-control study to determine~     whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good~     combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a~     marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years~     and with cART-sustained immunovirological control for at least 1 year.~   "
15626|NCT02852759|"~     Insulin resistant volunteers will undergo an 8-week cold treatment, 2 hours per day, to~     selective regions of the body enriched with brown fat including neck, supraclavicular and~     interscapular regions) in combination with electroacupuncture (EA). Their insulin~     sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation~     will be determined by analyzing fat biopsy samples and/or positron emission tomography and~     computed tomography (PET/CT)-scans.~   "
15627|NCT02852746|"~     The study aims to compare the performance and the 3D shoulder kinematics of volleyball~     attackers with and without scapular dyskinesis and shoulder symptoms in two physical~     performance measures of the upper extremity, and correlate their outcomes with a~     self-reported measure of function of the upper extremity.~   "
15628|NCT02852733|"~     The purposes of this study are :~        -  To know and to understand frequency and variability (quantitative and qualitative) of~          end-of-life emergencies in nursing homes.~        -  To know and to understand practices applied in these situations depending on the~          institution and the different reasons of hospital use.~        -  To know and to understand the practical and organizational elements, in nursing homes,~          that can determine a (re) hospitalization or an end-of-life~   "
15629|NCT02852720|"~     Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard~     of care for analgesia after cesarean section. There is no information on levobupivacaine~     pharmacokinetics post TAP after pregnancy.~      Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the~     electrocardiogram (ECG).~      Method: The investigators will study 12 healthy term pregnant patients, scheduled for~     elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with~     20 ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at~     1-2-6 and 12 hours post puncture. 2 ml of venous blood will be obtained at~     2-5-10-30-45-60-90 and 180 minutes. With a Holter machine we will study the effect of~     levobupivacaine plasma levels and the QTc changes.~      Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .~   "
15630|NCT02852707|"~     This study compares the performance and 3-dimensional shoulder kinematics between sides in~     unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers)~     and non-athletes during two physical performance measures of the upper extremity, one in an~     open kinetic chain position (unilateral seated shot put test) and the other in a closed~     kinetic chain position (upper quarter Y balance test)~   "
15631|NCT02852694|"~     The purpose of this study is to compare the effectiveness of weekly subcutaneously~     administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition~     -free 1-year remission compared with:~        -  daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease~        -  subcutaneously administered adalimumab in high risk paediatric Crohn's disease~   "
15632|NCT02852681|"~     This single-center, open-label, randomized, balanced, single-dose, two-treatment,~     two-period, two-sequence crossover study was conducted under medical supervision in 28~     healthy female volunteers.~   "
15633|NCT02852668|"~     The inexorable decline in motor skills during aging provides the investigators with an~     elderly population with various functional limitations. Among these, the ability to walk,~     being associated with the risk of falling has been studied by several authors. The adoption~     of strength and power training as an intervention strategy to reduce the negative effects~     arising from the physiological or pathological process of aging has been widely discussed in~     these studies. However, the effects of these interventions on biomechanical gait indicators~     have not been fully debated yet. Therefore, this study aimed to compare the effects of these~     two training protocols on functional capacities and biomechanical gait parameters of elderly~     women.~   "
15634|NCT02852655|"~     This research study is studying an immunotherapy as a possible treatment for Glioblastoma.~   "
15635|NCT02852642|"~     Introduction: the physiological aging process induces several structural changes in the~     musculoskeletal system. These, in turn, result in functional changes that are reflected in~     the senescent dependency, determining the reduction in their quality of life. Power training~     has been identified as ideal to mitigate the effects of aging. However, there are~     indications that an intervention based on the potentiation of the stretch-shortening cycle~     action is a better choice.~   "
15636|NCT02852629|"~     Observational two year study to evaluate the utility of a decision-support sheet on how to~     proceed in case of aggravation of a patient's condition with advanced disease.~   "
15704|NCT02851745|"~     The primary objective of the study is to evaluate the effect of linagliptin 5 mg daily~     versus the corresponding placebo on the LV systolic function (measured by midwall shortening~     analysis) in patients with T2DM and a documented baseline concentric LV geometry and LV~     systolic dysfunction.~   "
15705|NCT02851732|"~     The purpose of the study is assess the impact of and educational multifaceted intervention~     in adherence to evidence based thearapies prescription (according to local guidelines) for~     cardiovascular prevention in high risk patients for (lipid lowering agents, antiplatelets~     and ACE Inhibitors) in 12 months.~   "
15637|NCT02852616|"~     Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of~     Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen~     controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after~     the completion of the therapy.~      In the current study, we will investigate the progression of PTSD symptoms and emotional~     stress before, during and after therapy. After a semi-structured interview all participants~     will be asked to report in monthly telephone interviews their core symptoms. Structured~     interviews after 6 and 12 months are used to validate the outcome. A convenience sample of~     individuals with a PTSD will be offered participation in the study.~   "
15638|NCT02852603|"~     Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge~     blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD~     are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to~     establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This~     study is intended to collect the gene information in sporadic TAAD patients and to explore~     the relationship between genetic variation and the incidence of sporadic TAAD for further~     study.~   "
15639|NCT02852590|"~     Medications are the most commonly used clinical intervention and complications associated~     with their use are one of the most common causes of adverse events in health care. Adverse~     Drug Reactions (ADR) are a major cause of morbidity and pose a substantial burden on limited~     health care resources.~      Many drugs used to treat children in hospitals are either not licensed for use in children~     or are prescribed outside the terms of their product license (off-label prescribing). This~     is mainly due to the lack of clinical trials in this vulnerable population, and both~     practical difficulties and ethical considerations arising from involving children in~     clinical research.~      Drugs used within the specifications of the product license might be less likely to cause~     ADR compared to drugs that are either unlicensed or off-label for use in children. Few~     studies have shown a significant association between pediatric off-label drug use and ADR.~      To compare the probability of ADR after a licensed drug prescription versus the probability~     of ADR after prescribing a drug off-label in children, we are conducting a multi-center~     prospective observational study in different pediatric hospital wards in France.~      The availability of electronic health records made this study feasible. An automatic data~     extraction from hospital information systems has been implemented. A computer algorithm for~     determining pediatric drug labelling (i.e. off-label or unlicensed use) using the French~     summaries of product characteristics available in Thériaque® database has been developed.~     Detection of ADRs is carried out by health care professionals and research groups using a~     trigger tool and patients' electronic health records. The causality between ADRs and~     suspected medications is evaluated using the Naranjo and the French methods by regional~     pharmacovigilance centers. An independent pharmacovigilance board validates ADR evaluations,~     assesses both of their severity and avoidability, and indicates therapeutic alternatives to~     suspected medications.~      This is, to our knowledge, the first large multi-center and prospective study in France that~     evaluates the relationship between adverse drug reactions and unlicensed/ off-label drugs~     use in hospitalized children. The results of this study will provide more information on the~     prescription practice and the amplitude, nature and consequences of unlicensed/off-label~     drug use in hospitalized children. It will also help identify the risk factors of ADR that~     could be used to implement preventive actions, and guide future research in the field. An~     indirect benefit is represented by the increase of physicians' awareness in detecting and~     declaring ADRs and by communicating the results to the health professionals and to the~     public. This study is funded by ANSM (the French Medicine Agency).~   "
15640|NCT02852577|"~     The purpose of this study was to determine whether clonazepam and paroxetine are effective~     in the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and~     post-treatment.~   "
15641|NCT02852564|"~     Phase 1 study to provide quantitative characterization of the renal elimination of~     ethacrynic acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC)~     at the time of transurethral resection of bladder tumor~   "
15642|NCT02852551|"~     A single‑center, randomized, placebo‑controlled study consisting of both a single ascending~     dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability,~     pharmacokinetics and effect of food using PAT‑1251 orally administered to healthy subjects~   "
15643|NCT02852538|"~     This study aims to measure the effect of a neurobiologically-guided intensive family based~     treatment for adults with anorexia nervosa.~   "
15644|NCT02852525|"~     The purpose of this study is to further validate the use of probe-based confocal laser~     endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in~     a larger patient base.~   "
15645|NCT02852512|"~     The aim of the study is to perspectively compare the anatomical and functional outcomes of~     Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.~   "
15646|NCT02852499|"~     The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of~     Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on~     the general population and aims to cover several areas of environmental health research,~     including endocrine disruptors and air pollutants.~      The main objectives is to quantify the impact of pollution during pregnancy and the first~     years of life on three main health outcomes : growth, respiratory health and~     neuro-development ; and to better understand the biological mechanism (such as genetic~     analysis to study the role of environmental factors on genes expression as well as the role~     of genetic factors on health). The objective is to include 500 families.~   "
15647|NCT02852486|"~     The purpose of this study is to evaluate treatment-free remission after imatinib~     discontinuation in patients with chronic myeloid leukemia with deep molecular response.~     Before discontinuation, patients will receive pioglitazone associated with imatinib during 3~     months.~   "
15648|NCT02852473|"~     This study involves a breathing motion assessment in healthy subjects before and after~     continuous positive airway pressure (CPAP) administration using MRI images.~      The hypothesis for this study is that CPAP administration will significantly reduce~     breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so~     they possibly will not have to hold their breath during the procedure.~   "
15649|NCT02852460|"~     To evaluate the influence of rapid recovery on sleep quality following total hip replacement~     surgery~   "
15650|NCT02852447|"~     The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.~      The secondary objective is the analysis of predictors of change in the ovarian reserve after~     surgery~   "
15651|NCT02852434|"~     This study seeks to compare self-administered lidocaine gel for pain control during cervical~     preparation for dilation and evacuation (D&E) to paracervical block.~   "
15706|NCT02851719|"~     To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes~     additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.~   "
15961|NCT02848417|"~     The investigator proposes to perform a phase I/II study comparing two nutraceuticals and~     placebo that target mediators identified in the investigator's prior dynamic modeling study~     of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before~     treatment and on therapy to assess the modeling and the impact of the interventions on the~     homeostatic networks that have identified, with an added focus on the glutathione/redox~     system.~   "
15652|NCT02852421|"~     Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast~     surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of~     recovery, reduced chronic pain and possibly reduced metastasis with breast cancer.~     Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With~     multiple injections, the risk is increased for a pleural, an intraneural, and/or an~     intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use~     of ultrasound imaging enables real-time needle visualization during the procedure. This may~     improve efficacy and reduce the chances of complication like pneumothorax. Currently, there~     are no data comparing ultrasound-guided single injection technique with multiple injections~     technique with regards to extent of spread for PVB. Our objective is to investigate the~     extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at~     one versus five paravertebral sites for patients undergoing major breast surgery. In~     addition, the investigators wish to compare the performance time and duration of analgesia.~      Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with~     or without axillary node dissection will be randomized to receive either single or multiple~     injections PVB. The PVB will be performed in prone position under real-time ultrasound~     guidance using a para-sagittal approach.The patients in single injection group will receive~     single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous~     sham injections. Patients in the multiple injection group will receive five injections of~     PVB from T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural~     drift will be used as a sign of correct needle tip location and local anaesthetic spread.~     The pinprick method will be used to assess the extent of dermatomal blockade, 20 minutes~     following the completion of procedure. All patients will receive a standardized general~     anesthesia for the surgery. Any adverse events including pneumothorax, epidural spread, LA~     toxicity/seizure, total spinal, will be recorded.~   "
15653|NCT02852408|"~     Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity~     all over the world for gallstone. Although it has low morbidity, postoperative pain is~     challenging situation like every other operation.~   "
15654|NCT02852395|"~     This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and~     repeated doses, and to evaluate its potential effectiveness for treating insomnia.~   "
15655|NCT02852382|"~     This study evaluate the effects of scalp block versus local infiltration on haemodynamic~     response to head pin replacement and skin incision and postoperative analgesia in posterior~     fossa surgery~   "
15656|NCT02852369|"~     Objective: To determine the effectiveness of an upper extremity, task oriented training~     program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a~     stroke.~      Method: A single-subject AB series design with a follow-up to assess the effectiveness of~     TOTE Home which includes a maximum of 30, one hour sessions of training conducted in~     participants' homes. Repeated target measures of accelerometry and level of confidence to be~     analyzed throughout the study. Change scores from standardized assessments to be evaluated~     at baseline, post-intervention, and follow-up time periods.~   "
15657|NCT02852356|"~     The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse~     incubator and CultureCoin dish compared to standard big-box incubators and standard culture~     dishes used for embryo culture.~   "
15658|NCT02852343|"~     The investigators main objective is to show that OSNA technique is as accurate as~     pathological analysis (frozen section / HE staining and immunochemistry) to detect occult~     lymph node metastasis (micro and macrometastasis).~   "
15659|NCT02852330|"~     Collection of normative voltage tomography data during and/or immediately after electrode~     insertion into the cochlea using Surgical Assistant (SA16) research software and~     postoperatively at activation, three and twelve months post-activation with CS19 research~     software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532~     cochlear implant.~   "
15660|NCT02852317|"~     The purpose of this study is to assess diagnostic performance of urinary markers of detrusor~     overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine~     triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida~     patients.~   "
15661|NCT02852304|"~     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked~     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of~     cholesterol esters and triglycerides.~      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a~     fatty liver, hepatic fibrosis that can evolve up to cirrhosis.~      LAL deficiency is responsible for significant morbidity and early mortality in children,~     adolescents and adults in connection with a multi visceral disease reaching the liver,~     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or~     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for~     the synthesis of the LAL.~      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto~     blotting paper .~      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of~     its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver~     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis~     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.~      Inclusion period of 12 to 18 months (100 patients).~   "
15662|NCT02852291|"~     Multisite randomized trial of a parenting intervention in Liberia for caregivers of young~     children. Two main objectives of the Parents Make the Difference program are to teach~     parents (a) skills for decreasing harsh punishments and replacing those with positive ways~     to manage children's behavior and (b) skills for having more positive interactions with~     their children, including interactions that encourage learning. As a result of positive~     changes in parenting, the investigators expect that, over time, children's behavioral and~     cognitive well-being will improve and that future abuse and poor developmental outcomes will~     be prevented in the long-term.~   "
15663|NCT02852278|"~     The purpose of this study is to learn about rates of patient-reported disease progression in~     patients with motor neuron diseases (amyotrophic lateral sclerosis, progressive muscular~     atrophy, primary lateral sclerosis, hereditary spastic paraplegia) outside the clinical~     setting, and the patient-reported clinical characteristics that influence this rate of~     progression. All patients enrolled in CReATe Connect, a Rare Diseases Clinical Research~     Network (RDCRN) Contact Registry, will be invited via email to participate in this study.~   "
15664|NCT02852265|"~     Women currently using or starting a combined oral contraceptive will be offered study~     enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to~     evaluate if they continue the COC, continue the implant, or both, and to assess adverse~     events and bleeding patterns.~   "
15665|NCT02852252|"~     The study objective is to collect prospective data on cancer patients who undergo surgery~     and intraoperative imaging. The registry will include (but not limited to) cancer type,~     stage, intraoperative challenges to the surgeon, usage and results of intraoperative~     imaging, and recurrence surveillance.~   "
15667|NCT02852226|"~     UCSF is conducting an evaluation of a demonstration project. The aims of the CRUSH-PrEP for~     Women project are to integrate the delivery of a comprehensive PrEP package for HIV-negative~     at-risk women into primary care settings. The delivery of the PrEP package will leverage the~     well regarded reputation of the LifeLong primary care clinicians to provide a highly~     effective combination HIV prevention strategy including; PrEP, post-exposure prophylaxis~     (nPEP), repeat HIV and STI testing, treatment of sexually transmitted infections.~     Counselling for for sexual health promotion and services specifically designed for~     vulnerable women such as staying free of violence and domestic abuse will be offered as an~     integrated part of this package. UCSF will conduct evaluation activities only. The~     investigators expect that UCSF will enroll 50 participants in the evaluation assessments~     across the 15 months of data collection. Evaluation cohort participants will provide~     quantitative data to evaluate the linkage and engagement in care among clinic attendees as~     well as the uptake and use of Pre-Exposure Prophylaxis.~   "
15668|NCT02852213|"~     The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC~     delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in~     children with aromatic L-amino acid decarboxylase (AADC) deficiency.~   "
15669|NCT02852200|"~     Many tools to evaluate frailty have been developed. However, at the time our study was~     designed, none of these instruments had been validated in terms of psychometric properties.~     The aim of this study was to validate the modified version of the Short Emergency Geriatric~     Assessment (SEGAm) frailty instrument in elderly people living at home.~      It was an observational, longitudinal, prospective, multicentre study, set up in four~     departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions~     (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and~     was able to read and understand French, with a degree of autonomy corresponding to groups 5,~     or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic~     characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric~     validation was used to study feasibility and acceptability, internal structure validity,~     reliability, and discriminant validity of the SEGAm instrument. ~   "
15670|NCT02852187|"~     Prospective randomized clinical study comparing Signus MOBIS PEEK vs SIGNUS MOBIS II ST in~     patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1~   "
15671|NCT02852174|"~     Caring for a disabled adult, particularly those with long-lasting impairment, has been~     associated with elevated levels of stress, depression and anxiety among caregivers.Recent~     studies show that veteran caregivers experience higher levels of psychological distress than~     caregivers in the general population, highlighting the psychological needs of this~     population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control~     trial designed to test the effectiveness of a mindfulness at reducing stress, depression and~     anxiety in veteran caregivers in Champaign and Danville County.~   "
15672|NCT02852161|"~     A pilot study to assess the accuracy and acceptability of a magnet assisted capsule~     endoscopy in detecting esophageal pathology compared to standard endoscopy.~   "
15673|NCT02852148|"~     The aim of the study is to evaluate participant reported quality of life, safety, and~     overall performance with ACTICOAT in a clinical setting.~      ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a~     variety of wound types. It is widely used in routine clinical practice within the UK.~     ACTICOAT is CE marked and will be used within the intended indications for use. The proposed~     study is required for regulatory purposes.~      Primary Objective: To evaluate change in health related quality of life, associated with~     treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single~     index utility scores from baseline to 3 weeks.~      The study will also seek to gather and report relevant safety and performance data and~     evaluate change, where applicable, for outcomes including: clinical signs and symptoms of~     infection; wound length / width / depth; wound healing measures; tissue staining; pain,~     adherence, and pain on application / removal; wear time; adverse events and device~     deficiencies.~      In total 25 participants will be recruited into the trial, comprising a minimum of 8~     participants with a full or partial thickness burn and a minimum of 8 participants with a~     full or partial thickness chronic wound. All participants will have their wound dressed~     using ACTICOAT, and will be followed-up for 3 weeks.~   "
15674|NCT02852135|"~     Till date, the tracheal tube was considered as the gold standard for providing a safe~     glottic seal, especially for laparoscopic procedures under general anaesthesia.The~     disadvantages of tracheal intubation, which involves rigid laryngoscopy,are in terms of~     concomitant haemodynamic responses and damage to the oropharyngeal structures at insertion.~     Postoperative sore throat is also a serious concern.~      The PLMA and the SLMA are a new entrant to the family of LMA with some added features over~     the classic LMA.Several publications have reported the successful, safe use of Laryngeal~     Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no~     studies that have examined the application of Laryngeal Mask Airway in patients during~     lateral positioned laparoscopic general anesthetic surgery. The aim of this study is to~     observe the safety and efficacy when Proseal laryngeal mask or Supreme laryngeal mask used~     in lateral positioned laparoscopic surgery under general anesthesia.~   "
15675|NCT02852122|"~     The investigators determine the target number as 54 patients based on the following reasons:~     (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to~     99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would~     be 47 under the condition of 20% more distant metastasis cases were identified by the~     PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test.~     Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly~     diagnostic number for the high risk prostate cancer patients in our hospital annually is~     ~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until~     18 months since the study begin. The study could be completed in 2 years with 54 cases~   "
15745|NCT02851212|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     coadministered with canagliflozin in healthy fed and fasted participants.~   "
15962|NCT02848404|"~     The purpose of this study is to examine therapeutic efficacy of catergorical language~     fluency smartphone game apllication in mild congnitive imapirment and mild Alzheimer's~     dementia.~   "
15676|NCT02852109|"~     The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal~     injury and 15 patients negative for magnetic resonance examination with no trauma with~     DTI(diffusion tensor imaging). The investigators then determine the FA（fractional~     anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting~     area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the~     FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow~     Coma Scale) and coma time,so that the investigators can quantify the damage degree of~     patients' white matter fiber.By using fiber tractography the investigators can have the~     extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and~     give guidance for the clinical decision and the judgement of prognosis).~   "
15677|NCT02852096|"~     One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu)~     immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or~     multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical~     method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral~     heterogeneity.~   "
15678|NCT02852083|"~     This is a Phase II, multicentre, open-label, randomized, and controlled study, evaluating~     the efficacy and safety of combined modularized treatment of treosulfan, pioglitazone and~     clarithromycin in patients with with squamous and non- squamous cell lung cancer,~     respectively after platin failure.~   "
15679|NCT02852070|"~     Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two~     common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types~     of lower respiratory tract infection.~      Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml),~     including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy,~     and other bronchoalveolar lavage related adverse events.~   "
15680|NCT02852057|"~     This study focuses on glaucoma therapy by drug eluting contact lenses. The contact lens will~     be loaded with timolol maleate and dorzolamide hydrochloride, both of which are commonly~     used ophthalmic drugs. Additionally, the lenses will contain vitamin E ((+) α-tocopherol) as~     an additive for achieving extended release of the drugs.~      This study is to assess the safety of the drug loaded contact lenses and the effectiveness.~     Effectiveness will be a drop in IOP after using the lenses.~   "
15681|NCT02852044|"~     For decades, it has been known that post-meal blood glucose concentrations were associated~     with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose~     tolerance test (OGTT) has been used since at least 1923 and has remained the most common~     test for assessing glucose tolerance. Arterial blood (or arterialised blood using heated~     hand technique) is most appropriate for determining glucose tolerance and insulin~     sensitivity since this best represents the concentrations of metabolites and hormones that~     peripheral tissues are exposed to. It is essential to investigate whether venous blood~     (sometimes used during an OGTT) is representative of arterialised blood during an OGTT, and~     under different metabolic conditions.~      The investigators want to understand whether OGTT-derived insulin sensitivity indices differ~     from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest~     vs lower-limb exercise) influences the difference between forearm venous and arterialised~     concentrations of glucose and insulin during an OGTT.~   "
15682|NCT02852031|"~     The purpose of this initiative is to improve care and outcomes for infants with HLHS by~     expanding the NPC-QIC national registry to gather clinical care process, outcome, and~     developmental data on infants with HLHS between diagnosis and 12 months of age, by improving~     the use of standards into everyday practice across pediatric cardiology centers, and by~     engaging parents as partners in the process.~   "
15683|NCT02852018|"~     The aim of this project is to identify common genetic polymorphisms associated with the~     occurrence of rhythmic events in patients with severe cardiomyopathy.~   "
15684|NCT02852005|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the~     AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who~     previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.~   "
15685|NCT02851992|"~     This is a multicenter, non-controlled, prospective study. 250 subjects (GTS standard and~     lateralized) will be recruited. Study will be conducted in centers across Europe.~   "
15686|NCT02851979|"~     Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of~     pregnancy. They are considered as an important risk factor for subsequent neuropsychological~     deficiency. Current pharmacological treatments are not very effective, and have side effects~     (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs~     with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the~     incubator's pillow might reduce the frequency of apneas. This latin square design study will~     test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor~     duration, intensity, and sequence using three different odors, to reduce apneic episodes~     measured using 24-registration of heart and respiratory rates.~   "
15687|NCT02851966|"~     The investigators hypothesize that sperm production varies with time in men with no sperm in~     semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to~     monitor these changes. The investigators further hypothesize that TEX101 levels may be used~     to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide~     the highest successful rates of sperm retrieval.~   "
15688|NCT02851953|"~     The purpose of the present clinical investigation is to collect data regarding the safety~     and effectiveness of the Aqueduct 100 device.~      The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach~     desired cervical dilation, and the time frame required to reach desired cervical dilation.~   "
15689|NCT02851940|"~     The investigators aim at prospectively comparing procedural pain, adverse events and~     rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline~     injection in patients with symptomatic hemorrhoidal disease~   "
15758|NCT02851043|"~     This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The~     pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing~     indices non-invasively. This study compares the pneuRIP to an existing Respitrace system~     (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties~     will be monitored with both systems.~   "
15690|NCT02851927|"~     Undiagnosed pleural effusion is a diagnostic dilemma especially in exudative pleural~     effusions (EPE). 20-40 % are unable to be attributed to a specific diagnosis, even after~     thoracentesis and closed pleural biopsy. Thoracoscopy has been demonstrated to increase the~     diagnostic yield in undiagnosed EPE. The diagnostic yield of thoracoscopy in malignant and~     TB pleural effusion ranges from 91% to 94% and 93% to 100%, respectively.~      Rigid thoracoscopy has traditionally been the modality of choice. The recently introduced~     semirigid thoracoscope provides ease of handling like a flexible bronchoscope. However,~     there are concerns about the diagnostic yield of semi-rigid thoracoscopy when compared with~     rigid thoracoscopy. According to the available literature, the yield of semirigid and rigid~     thoracoscopy is almost similar if adequate pleural biopsy is obtained. However there are~     concerns that with semi-rigid thoracoscope, there might be greater incidence of inability to~     obtain adequate pleural biopsy. On the other hand, the use of conventional rigid~     thoracoscope may be associated with greater procedure related pain.Mini-Thoracoscopy is a~     newer rigid thoracoscopy instrument which is smaller in diameter (5.5 mm) and may allow~     pleural biopsy with a smaller incision. There is scant literature on its utility. The~     investigators hereby propose to undertake a randomized comparison of rigid 'mini~     thoracoscope' vs semi rigid tharacoscope in undiagnosed pleural effusions.~   "
15691|NCT02851914|"~     Depression is seen in 9-11% of ALS patients and adequate and proper treatment is needed. In~     this study, ALS patients will be screened for depression using self-reported multiple choice~     questionnaire. Patients who fulfill the criteria for depression based on this screening tool~     will be evaluated by psychiatrist before inclusion in the study. The investigators will also~     measure quality of life and functional status by simple questionnaires. The patients will be~     allocated into two treatment groups to receive either TCA or SSRI for 12 weeks. Patients~     will be evaluated every 4 weeks and phone calls will be made in between the visits if needed~     to assess about efficacy and any side effects. If any patient reports having suicidal~     thoughts on any of these phone calls or clinic visits, he/she will be immediately sent to~     the ER for appropriate management. The investigators will repeat the questionnaires in the~     clinic visits, and use them in the data analysis to look for any improvement and to compare~     the two medication classes used in this study. This data may be used later on to do larger~     studies and help to make standard recommendations in treating depression in ALS patients.~   "
15692|NCT02851901|"~     This double-blind placebo-controlled design with 374 cancer patients will compare standard~     varenicline treatment (12-weeks active + 12-weeks placebo) to extended varenicline treatment~     (24-weeks active) for increasing week 24 & 52 biochemically-confirmed 7-day point prevalence~     abstinence, assess effects of extended varenicline therapy on QOL, including varenicline~     side effects, and assess changes in affect & cognitive impairment as mediators of extended~     varenicline therapy effect on quit rates.~   "
15693|NCT02851888|"~     The purpose of this research is to determine differences in outcomes in patients who do, or~     do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip~     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement~   "
15694|NCT02851875|"~     The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about~     scleroderma. This information could be used in future research to increase the understanding~     of disease mechanisms, treatments, and outcomes. This research may also help develop new~     therapies, novel measures of disease assessment or identify previously unknown~     manifestations of the diseases. A prospectively followed cohort is an integral component of~     future translational and clinical research programs. A registry for scleroderma would allow~     for information to be gleaned about patients in real-world situations in an effort to~     improve the reality, generalizability and applicability of information gathered.~   "
15695|NCT02851862|"~     The purpose of this study is to learn more about the natural history of Late Onset GM2~     Gangliosidosis (Tay-Sachs disease and Sandhoff Disease) to inform future clinical trials.~   "
15696|NCT02851849|"~     The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c)~     during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects~     with Type 2 Diabetes Mellitus (T2DM)~   "
15697|NCT02851836|"~     this study aims to validate a picture data set that particularly activates the attachment~     process and that could be used in attachment studies.~   "
15698|NCT02851823|"~     The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG~     laser therapy to that of scaling and root planning with hand instruments in nonsurgical~     treatment of chronic periodontitis.~   "
15699|NCT02851810|"~     The study aims to identify specific visual scanning patterns of attachment pictures in~     adolescent with different attachment style.~   "
15700|NCT02851797|"~     it is a randomised, double blind, parallel group, placebo controlled study. A total of 213~     male ambulant subjects will be randomised 2:1 (givinostat:placebo).~      Subjects will be stratified for their concomitant use of steroids in 4 strata:~        1. Deflazacort daily regimen~        2. Deflazacort intermittent regimen~        3. Other steroids daily regimen~        4. Other steroids intermittent regimen. The study duration is planned for 19 months.~   "
15701|NCT02851784|"~     The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of~     combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in~     hepatocellular carcinoma(HCC).~   "
15702|NCT02851771|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of pneumonia caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribo~     Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo~     Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new~     pathogens described in POC laboratory, this study proposes to expand the etiological~     diagnosis strategy of pneumonia after POC tests.~   "
15703|NCT02851758|"~     The investigators propose a robust therapeutic intervention to ameliorate myocardial~     ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients~     requiring extracorporeal membrane oxygenation (ECMO), by direct injection of autogeneic~     mitochondria into the ischemic myocardium.~   "
15707|NCT02851706|"~     Background:~      Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer~     deaths in the U.S. in children and adults. Little progress has been made in treating brain~     tumors. Researchers want to learn more about these tumors by studying people who have them.~      Objectives:~      To understand brain and spinal cord tumors better and uncover areas for further research.~     Also, to connect people with these tumors to doctors who can help them manage their illness~     and give them new treatment options.~      Eligibility:~      People ages 3 and older who have been diagnosed with a tumor of the brain or spinal cord.~      Design:~      Participants will have an initial (baseline) visit. They will have their medical history~     taken and undergo physical and neurological exams. They will have blood tests. They may have~     scans (imaging studies) of the nervous system.~      If participants have urine or cerebrospinal fluid collected during their regular care,~     researchers may save some.~      Brain tumor tissue from a prior surgery may be studied.~      Genomic DNA testing will be done on samples. Results will be linked to participants medical~     and/or family history.~      The number of study visits at NIH will depend on the wishes of participants and their local~     doctors.~      Participants will take a brain tumor survey on a computer. They can take it all at once or~     in 6 separate sections.~      Participants will answer questions about their general well-being. They will answer~     questions to learn if they have symptoms of depression or anxiety.~      Physicians will discuss test results with participants. They will recommend management and~     treatment options.~   "
15708|NCT02851693|"~     The diagnosis of cutaneous lesions often involves the use of surgical and invasive~     procedures such as biopsy or excision in order to analyze the structure and appearance of~     the fabric pathologists. With recent advances in optical and electronic fields, considerable~     efforts were produced to build high-performance optical instruments, able to transcribe the~     internal structure of the skin with varying degrees of depth and variable resolution.~      The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and~     in real time. This area is booming and new optical instruments are created to eventually be~     able to offer a reliable alternative to invasive techniques.~      The optical properties of different tissues have been studied for several years by different~     research groups: the coefficient of light absorption by the tissue both in vivo and in~     vitro, the coefficient of light scattering or the index refractive were characterized in~     various tissues that make up the skin.~      Other studies have focused on melanoma detection by multispectral optical techniques, or via~     the technique of optical coherence tomography (OCT) performed on lesions suspicious for~     cancer, but without linking criteria between these two techniques.~      However, no study to date and to our knowledge has been able to demonstrate the different~     optical parameters obtained with OCT and can be directly connected to known and~     histopathological parameters commonly used in the diagnosis of lesions skin. This study aims~     to verify if it is possible to determine the parameters measured in OCT that would~     discriminate between benign and malignant lesions.~   "
15709|NCT02851680|"~     In the context of screening for infectious fungal diseases in patients with malignant~     haemopathy, and particularly patients with acute leukaemia, the investigator aims to~     evaluate the performance of an already commercialized but little used serum screening test~     (Fungitell® test) and to determine its place in the management strategy for invasive~     aspergillosis.~   "
15710|NCT02851667|"~     According to the Social Welfare Department statistics, Kwun Tong has been ranked as the~     highest for the reported cases of elderly abuse (12.3%), the second and fourth highest for~     the reported cases of battered spouse (9.2%) and child abuse (7.9%) respectively. To~     strengthen family well-being in the Kwun Tong community, the investigators adopt a~     community-based participatory (CBP) approach and implement a community-based Learning~     Family campaign in Kwun Tong district with the investigators collaborator, the Christian~     Family Service Centre (CFSC). The campaign aims to promote family health, happiness, and~     harmony (3Hs) through cultivating cooperative and self-regulated family learning culture in~     Kwun Tong district.~   "
15711|NCT02851654|"~     Dry eye syndrome is a benign situation however its impact on patient's quality of live and~     on health system is not trivial. One problem is the lack of correlation between patient's~     symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of~     increased interest in this pathology particularly its frequency. To date no treatment of dry~     eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has~     mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals~     between 2 blinks is not gaussian but exponential. In this study, it is proposed to use~     modern eye-movement recorder to measure the blink frequency on longer duration (12 minutes)~     while reading on a screen computer and during a face-to-face interview before and after~     treatment of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.~   "
15712|NCT02851641|"~     The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using~     a pushed probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).~      In the investigator's experience, this risk seemed to minus using a pushed probe rather than~     the classical pulled-type probes.~      A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold~     standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the~     use of an orolaryngeal mask. A forthcoming study will evaluate the results of this~     anesthetic change.~   "
15713|NCT02851628|"~     The investigation is a prospective non-blinded and non-randomized clinical investigation.~     The investigation is designed to assess the gender-based sizing which the Genos mask concept~     is based on and how it compares to a conventional sizing present in the Prototype Full Face~     Mask (PFFM) mask.~   "
15714|NCT02851615|"~     The objective of this study is to determine the feasibility and acceptability of SCThrive, a~     an innovative, technology-enhanced, group self-management intervention that uses a mixed~     in-person and online format and supported by a tailored mHealth tool, iManage. The study~     will also evaluate the initial efficacy of SCThrive for increasing behavioral activation~     (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators~     hypothesize that participants in the SCThrive group will show greater BA (primary outcome)~     at post-treatment than the attention control group, and that participants in the SCThrive~     group will continue to show significantly greater BA at the six week follow-up compared to~     the attention control group. Investigators will also explore whether SCThrive is associated~     with greater improvements in self-management behaviors and quality of life (secondary~     outcome) compared to attention control at the six-week follow-up assessment.~   "
15715|NCT02851602|"~     HDL in obese non-diabetic patients show major alterations in their function and thus their~     cardio-protective effects. These alterations could be explained by the quantitative and~     qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules~     play a major role in HDL function and probably present early modifications in obesity, even~     before the onset of glycaemia deregulation.~      The aim of this study is to show the presence of qualitative and quantitative modifications~     of phospholipids and sphingolipids in HDL from obese patients compared with HDL from~     non-obese controls.~   "
15716|NCT02851589|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.~   "
15717|NCT02851576|"~     Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by~     a clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their~     original donor or a haploidentical donor, in case of Umbilical cord blood transplantation,~     in the event of refractory ADV infection or disease.~   "
15718|NCT02851563|"~     The purpose of this study is to learn more about the natural history of Canavan disease~   "
15719|NCT02851550|"~     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked~     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of~     cholesterol esters and triglycerides.~      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a~     fatty liver, hepatic fibrosis that can evolve up to cirrhosis.~      LAL deficiency is responsible for significant morbidity and early mortality in children,~     adolescents and adults in connection with a multi visceral disease reaching the liver,~     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or~     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for~     the synthesis of the LAL.~      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto~     blotting paper.~      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of~     its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver~     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis~     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.~      Inclusion period of 12 to 18 months (100 patients).~   "
15720|NCT02851537|"~     EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is~     responsible. The objective is to study EPIRMEX at the age of 5 years corrected executive~     functions (EF) in children born very prematurely in relation to structural brain~     abnormalities in magnetic resonance imaging (MRI) (technical conventional and advanced)~     performed at the age of term. The current demand is expected to finance a project on a~     subset of the population of premature EPIRMEX subjects who had an advanced technique as~     magnetic resonance spectroscopy (MRS). It is a recent imaging technique for a study of the~     cerebral metabolism. It is based on the detection of cerebral metabolites, and the~     variations of their concentration to characterize different pathologies. In most cases,~     combinations of metabolites are informed creatine + phosphocreatine (CR),~     glycerophosphocholine + phosphocholine (CHO) + Nacétylaspartate Nacetylaspartylglutamate~     (NAA), myoinositol (INS) and lactate (LAC). In the premature newborn, the NAA / CHO ratio~     increases with age in all brain regions. The LAC / NAA ratio decreases significantly with~     age in the thalamus, basal ganglia, the corticospinal tract, and parietal white matter tends~     to decrease elsewhere . A number of studies show that proton spectroscopy term can predict~     the long-term newborn who presented an anoxic-ischemic encephalopathy .These studies~     indicate that an increase in lactate and a decrease in NAA are correlated with abnormal~     neurological development. And decreases in NAA / CR and / or NAA / CHO ratios are predictive~     of motor abnormalities in children with anoxic encephalopathy presented an ischemia . These~     decreases were also measured in the basal ganglia, occipital cortex, and areas near the~     last. Few studies have explored the magnetic resonance spectroscopy of proton-term~     prediction of the future of large premature.~   "
15721|NCT02851524|"~     Falls in the elderly population are a major public health problem because of their frequency~     and their consequences, notably in terms of dependence their cost to society. In most cases,~     balance disorders related to an impaired vestibular system are blamed, even though there is~     no formal evidence that this is the case.~      Vestibular tests in routine otoneurological practice are based on the exploration of~     vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to~     screen for vestibular disorders in falls.~      A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as~     the pathways via which vestibular afferents are transported to the subject's conscience.~     Thanks to this apparatus, a stimulus of body movement will be generated, but with limited~     tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone~     is able to indicate to subjects their position in space. The subject will be required to~     detect oscillatory movement, and then to distinguish between a vestibular stimulus and a~     pulsed auditory stimulus.~      The study hypothesis is that the movement stimulation generated by our prototype will be~     sufficient to stimulate the vestibular system, which will manifest itself as a conscious~     sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.~   "
15722|NCT02851511|"~     A randomized two-phase clinical trial will enroll 360 participants with age-related~     cognitive decline, but not Alzheimer's disease or other neurodegenerative diseases~     (MoCA>25). Cognitively healthy elderly adults will undergo a CT intervention or education~     training-control (TC) condition in combination with transcranial direct current stimulation~     (tDCS) or sham tDCS control. The CT intervention will employ a suite of adaptive training~     tasks (Double Decision - Useful Field of View, Card Shark - Working Memory, and Freeze Frame~     - Arousal-Alerting) from the POSIT Science Brain HQ6, a well validated CT method for~     enhancing cognitive functioning in the elderly. TC will involve exposure to educational~     nature videos and related content questions of the same interval and duration as CT,~     providing a well-matched active control. Participants will receive CT or TC in conjunction~     with tDCS or sham/placebo prefrontal stimulation administered during training. Participants~     will be assessed at baseline, after CT (12 weeks), and at 12-month follow-up. At each time~     point, a comprehensive neurocognitive, clinical and multimodal neuroimaging assessment of~     brain function, metabolic state, and brain structure will be conducted. Functional magnetic~     resonance imaging (FMRI) will be used to assess brain response during working memory,~     attention and memory encoding. Proton magnetic resonance spectroscopy (MRS) will assess~     cerebral metabolites and gamma-aminobutyric acid (GABA) concentrations. GABA concentrations~     from MRS will provide a sensitive marker of neuro-plastic change in task-associated brain~     regions. Alzheimer's disease risk factors (APOE4, familial history), baseline~     clinical/demographic characteristics (e.g., diabetes), and neuroimaging biomarkers (e.g.,~     white matter abnormality load) will assess factors with predictive value for individual~     response to tDCS and CT. Based on power analyses of intervention effects, 80 participants~     will be randomized to the four treatment conditions in phase 1. Following the intervention,~     CT (n=40) and TC (n=40) conditions will be compared. Interim analyses aimed at showing that~     CT has previously established strong effects on cognitive outcomes will be performed,~     thereby enabling elimination of the TC condition. Phase 2 will enroll the remaining 280~     participants into the two CT intervention conditions.~   "
15806|NCT02850419|"~     The 105-15-201 study is designed to assess the effectiveness and tolerability of the~     combination of heat-activated target therapy (radiotherapy + hyperthermia +~     lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer~     patients.~   "
15723|NCT02851498|"~     This controlled weight loss trial in adults at cardiometabolic risk (elevated~     triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel,~     high-protein pasta and cereal to examine the physiological impact of stealth substitution of~     dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and~     dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone~     PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM~     cereal) was matched with conventional flaked cereal. Participants were instructed to follow~     an energy restricted diet (-500 kcal/d) and incorporate a test food into each of three meals~     over a 24-hour period. The diet-induced changes in body mass and lean body mass were tracked~     as well as changes in in insulin sensitivity and common blood biomarkers.~   "
15724|NCT02851485|"~     This is an open-label study to determine the pharmacokinetics of a new tablet formulation of~     GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human~     study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972~     administered as tablet will also be investigated in this study. A dose of 600 mg has been~     selected. The study is a phase I randomized open-label cross-over study with three single~     dose treatments:~      A) 600 mg GLPG1972 oral solution after overnight fast,~      B) 600 mg GLPG1972 oral tablet after overnight fast,~      C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.~      A washout of at least 6 days between subsequent dosing days is respected so that no~     measurable plasma levels or biologically significant effects are remaining. There will be~     frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be~     selected according to the inclusion and exclusion criteria and 2 subjects each will be~     randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)~   "
15725|NCT02851472|"~     The investigators seek to determine whether providing inhaled nitric oxide (iNO; a~     vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of~     preterm neonates during and after the subject receives a packed red blood cell transfusion~     (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled~     nitric oxide vs. placebo at these body sites to determine whether iNO will alter the~     fractional tissue oxygen extraction. Treatment and control groups will be compared to each~     other at equivalent epochs as will individual patients before, during and after the PRBC~     transfusion.~   "
15726|NCT02851459|"~     This study is the first phase of a trial examining decision making about vaccines. This~     phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held~     by parents of young children and pre-adolescents. The participant's vaccine beliefs will be~     assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A~     vaccine-related message that appeals to the individual's three most or least emphasized~     moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be~     assessed to determine the impact of the message.~   "
15727|NCT02851446|"~     Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory~     failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for~     patients in the last two categories for whom it significantly prolongs life expectancy.~     Overall, the treatment is well tolerated, its principal adverse effects being discomfort~     related to the mask.~      In certain patients, morning dyspnoea when the mask is removed has been described. This is~     disabling as it limits everyday activities for at least 30 minutes, and defines~     deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles~     of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic~     work after a night of rest.~      The aim of this study is to investigate the prevalence of and factors associated with~     reventilation syndrome (DS) in a population of patients with ventilation whatever the~     reason, in a stable state, and followed by the medical devices department of Dijon CHU, so~     as to better understand the mechanisms. Patients with DS will subsequently be invited to~     participate in a therapeutic trial.~   "
15728|NCT02851433|"~     Heart surgery is a considerable source of stress for the myocardium that must be minimized.~      Troponin Ic is a reliable marker to determine the level of this myocardial stress.~      Studies have shown that post-conditioning with AVH has a protective effect on the~     myocardium, if the treatment is initiated at the start of the ischemia.~      The aim of this study is to evaluate the protective effect on the myocardium (by measuring~     troponin levels) of the association of pre-conditioning and post-conditioning with~     Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve~     replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with~     Propofol.~   "
15729|NCT02851420|"~     The detection of suspect lesions is based on the clinical examination of the oral cavity and~     pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology~     examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be~     difficult. On the one hand , it is an invasive procedure, and may engender complications,~     and on the other hand, certain modifications of the mucosa may be discrete, or not~     particularly specific or, on the contrary, disseminated or extremely widespread.~      Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to~     restrict the use of biopsies to patients in whom it is really necessary 2) and to identify~     the area where the biopsy should be done in cases of multiple lesions. In this context,~     spectroscopy could be a promising alternative.~      The investigator puts forward the hypothesis that cancerous and precancerous lesions of the~     mucosa of the upper airways and digestive tract present a characteristic spectrometric~     profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show~     signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be~     diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal~     wavelengths absorbed by haemoglobin.~      This pilot study will make it possible to construct an algorithm that could be used to~     classify lesions of the upper airways and digestive tract as either seemingly benign or~     cancerous.~   "
15730|NCT02851407|"~     This study is to compare the efficacy and safety of defibrotide versus best supportive care~     in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients~     undergoing hematopoietic stem cell transplant who are at high risk or very high risk of~     developing VOD.~   "
15807|NCT02850406|"~     This study consists of two parts, Part A and Part B. Part A is a single dose PK study in~     adolescent subjects with Sickle Cell Disease. Part B is a multiple dose safety, exploratory~     efficacy and PK study in adolescent Sickle Cell Disease subjects.~   "
15731|NCT02851394|"~     Sternotomy, the reference approach for heart surgery, may induce profound and intense~     post-operative pain. One method of analgesia used is patient-controlled intravenous~     morphine.~      The analgesic efficacy of continuous wound infiltration at the sternum following heart~     surgery has been demonstrated.~      The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.~      The aim of this study is to determine whether a bolus of tramadol associated with the~     continuous administration of levobupivacaine via the wound catheter could potentiate the~     local anaesthetic effects, thus leading to a decreased consumption of postoperative~     intravenous morphine, and a decrease in morphine-related side effects.~   "
15732|NCT02851381|"~     Single compassionate use subject is an 83 year old woman with a history of lymph node~     positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern~     Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive~     chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis~     in combination with gemzar. The patient is currently being treated and is tolerating gemzar.~   "
15733|NCT02851368|"~     This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with~     indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung~     nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled~     camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a~     fluorophore with a long-standing high safety profile.~   "
15734|NCT02851355|"~     Clinical follow-up survey of the Norwegian material of paediatric patients who received~     therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life,~     education, work, family and children, delayed effects of tumour disease and treatment,~     endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.~   "
15735|NCT02851342|"~     In this study, 100 persons with Multiple Sclerosis and 50 matched controls will be examined~     with magnetoencephalography (MEG), magnetic resonance imaging (MRI) and cognitive tests. The~     primary hypothesis for the study is: Interhemispheric connectivity, determined using graph~     theoretic analysis (GTA) on source-reconstructed MEG data, is a biomarker for cognitive~     deterioration in MS, which has value at the individual patient level.~   "
15736|NCT02851329|"~     The investigators propose a non-invasive prognostic tool for TKIs resistance in patients~     with stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography~     phenotypic features, which can be conveniently translated to facilitate the pre-therapy~     individualized management of EGFR TKIs in this disease.~   "
15737|NCT02851316|"~     Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term~     outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it~     is unclear if WBV influences athletic tasks such as running. The purpose of this study is to~     evaluate the influence of WBV on running biomechanics in individuals with ACLR.~   "
15738|NCT02851303|"~     This study investigates the use of methadone versus morphine wean for the treatment of~     neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who~     require pharmacotherapy for NAS will receive a methadone wean, and half will receive a~     morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be~     studied.~   "
15739|NCT02851290|"~     Hypospadias is one of the most common genitourinary (GU) malformations, seen in~     approximately 1 of 250 male live births. Common methods of local anesthesia administration~     for hypospadias surgery include caudal and dorsal penile nerve blocks. While both methods~     are known to be effective with minimal risk, the effect on post-operative complications is~     not well-established. The purpose of this randomized controlled trial is to evaluate if~     caudal versus dorsal penile nerve block results in higher rates of post-operative~     complications.~   "
15740|NCT02851277|"~     The purpose of this study is to evaluate the safety and tolerability of ASP0892 after~     intradermal or intramuscular injection in adults with peanut allergy.~   "
15741|NCT02851264|"~     The aims of the present study：~        1. To investigate the diagnosing value of optical enhancement technology for early~          esophageal squamous neoplasia.~        2. To assess the detection rate of early esophageal squamous neoplasia by virtual~          chromoendoscopy with optical enhancement technology .~   "
15742|NCT02851251|"~     These exams are vital to protect healthy neonates from blindness. The purpose of this study~     is to better screen ocular disease in otherwise healthy neonates using wide-field digital~     imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital~     Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network~     will be built with the collaboration of eight hospitals from different parts of China.~   "
15743|NCT02851238|"~     This study aims to prove that driving pressure limited ventilation is superior in preventing~     postoperative pulmonary complications to existing protective ventilation.~   "
15744|NCT02851225|"~     Currently the Toulouse University Hospital, the organization of transfusion care for~     patients requiring regular transfusions is based on reading the biological results received~     by fax before confirming or disproving a planned hospitalization or program a new hospital~     if needed.~      Remote transmission of laboratory results, replacing fax communication might facilitate the~     coordination of care that results from these laboratory results and provide a better respect~     of the Plan Custom Care Transfusion (PPST).~      The investigators offer organization of transfusion supportive care for patients with~     conditions requiring biological monitoring using the techniques of information and~     communication telemedicine.~      Primary objective~      - Assess the feasibility of setting up an upload procedure biological results in the~     treatment of transfusion supportive care.~      Secondary objectives~        -  Assess the evolution of the quality of life of patients during the treatment~        -  Assess changes in patient satisfaction over the support~        -  Assess the evolution of the satisfaction of the medical team at home and at Toulouse~          University Hospital~        -  Describe the programming time (hospitalization, consultations)~        -  Estimate the loss of biological results~        -  Assessment of the descriptive use of hospitalization, consultation and biological~          examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates~          for hospitalizations, NGAP rates for consultations and biology of nomenclature (NABM)~          for biological tests.~   "
15808|NCT02850393|"~     Mental-health conditions affect million people worldwide. The economic burden of mental~     illness is enormous and the economic health of both developing and developed nations will~     depend on controlling the staggering growth in costs from mental disorders.~     Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that~     affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions~     (persistent intrusive thoughts and images with highly distressing contents) and compulsions~     (repetitive activity), and severely impairs the lives of those affected. Despite their~     interest as effective and affordable care and rehabilitation, cognitive therapeutic profits~     too little from the increasing accumulation of knowledge in neuroscience, and~     neuroscientists pay too little attention to the challenges faced by clinical psychologists~     and psychiatrists. To reduce this cultural gap, two teams specialized in the study and~     multimodal imaging of healthy participants and clinical patients with mental health~     disorders, the UMR-S INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team~     (UMR-S 6301 CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an~     integrated approach of the neural mechanisms at stake from basic neuroscience using~     state-of-art neuroimaging techniques, to novel and ground breaking psychological~     intervention. Both teams evolve at the brain imaging Cyceron center in Caen in connection~     with the Mental Health and Addictology Center, offering unique opportunities for such~     translational research. This project will capitalize on recent evidence showing that healthy~     participants can prevent unwanted images from entering consciousness using inhibitory~     control and memory suppression techniques, disrupting traces of the memories in sensory~     areas of the brain, and weakening their vividness and later reentrance. OCD is characterized~     by aberrant and excessive visual intrusions, usually extremely vivid, detailed, and~     unpleasant. These distressing images are particularly uncontrollable and may frequently~     initiate compulsive rituals. In a first phase of this proposal will use functional magnetic~     resonance imaging (fMRI) to develop a neurobiological model of the cognitive computations~     achieved by inhibition network to suppress memory. To achieve this goal we will develop an~     attentional model of healthy memory inhibition functioning, simulating the deployment of~     attentional resources and the different mental processes at stake during suppression. Using~     sophisticated analyzing tools of fMRI data, we will use this model to decode and infer the~     representational content of the brain inhibition network, and further refine the~     connectivity pathways which underlie such control. The lack of a strong neurobiological~     model prevents the development of therapies which would increase functionality of this~     network and optimize intervention aiming to disrupt mental intrusions and obsessions. In a~     second phase, we will assess whether memory suppression may be transferred and trained in~     OCD patients using images depicting their own obsessions, as a promising avenue to reduce~     their symptoms on the long run. In addition, fMRI and other brain structural acquisitions~     will be collected before and after cognitive training to memory suppression, offering a~     unique opportunity to observe the online dysfunction of intrusion control in OCD patients~     and to identify neurobiological markers predictive of training outcome and network~     reconfiguration with training. A fundamental goal of motivated forgetting involves not only~     to exclude unwelcome content from consciousness but also to reduce their later emotional~     impact by doing so. In parallel of these two main phases, we will thus also measure~     physiological markers of autonomic nervous system activity changes in response to suppressed~     images to better identify the consequences of memory suppression on emotional states,~     anxiety, and mental health in general.~   "
15746|NCT02851199|"~     Electroencephalograhy (EEG) is used as a tool for diagnosing epilepsy/convulsions.~      During the recording, especially for childen who are suspected of having abbcence epilepsy~     the investigators will perform an EEG recording including a provocation test of~     hyperventilation in order to induce epileptic discharges.~      There is no clear instruction about the position of the child during performing this~     hyperventilation provocation.~      Clinical observations showed that this provocation is more effective when it's performed in~     the siiting position.~      No study was previously performed to investigate this issue~   "
15747|NCT02851186|"~     Objectives:~      To examine the efficacy and safety of electroacupuncture (EA) combined with auricular~     acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for~     gynecological diseases.~      Hypothesis:~      Acupuncture is effective and safe to reduce postoperative pain during the first 5 days~     following surgery as compared to a sham control.~      Design and strategy:~      This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two~     subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture~     treatment or sham control. Subjects in both groups will undergo standard operation procedure~     and receive post-operative analgesics based on usual care.~      Study instrument:~      A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome~     assessment.~      Intervention:~      Subjects in the treatment group will receive EA combined with AA within two hours before~     operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days.~     Subjects in the control group will receive non-invasive sham procedure in the same schedule.~      Main outcome measures:~      Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after~     surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge.~      Secondary outcome:~      Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D,~     EQ-5D-5L and adverse events will be documented and compared between groups.~      Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the~     Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's~     T-test.~      Expected outcome: AUC of the acupuncture group is expected to be significantly lower than~     sham acupuncture group.~   "
15748|NCT02851173|"~     This is a mechanism-driven translational project to test the efficacy of transcranial~     low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged~     adults.~   "
15749|NCT02851160|"~     Qualitative study on data from interviews such patients, relatives and doctors involved in~     the implementation of cancer care. Framework type of method using grounded theory~   "
15750|NCT02851147|"~     The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit~     Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and~     subsequently submitting a questionnaire and hold an interview with the operator.~      Of special interest for the study is to confirm whether the illumination level of SL-D301 is~     enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower~     than other existing Topcon digital ready slit lamps due to regulations that limit the~     maximum light intensity on the human eye. The SL-D301 will be compared against the predicate~     device SL-3G.~   "
15751|NCT02851134|"~     This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in~     individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.~   "
15752|NCT02851121|"~     The main goal of this study is to better understand the link between motor system (action)~     and perception in variable sensorial forms by examining the time course and the dynamic of~     electroencephalography (EEG) activations. To do so, differents sensimotor study protocols in~     linguistics and in the fiels of emotional and spatial perception will be realised in order~     to study prcisely differents links parception-action.~   "
15753|NCT02851108|"~     Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum~     malaria treatment in African children: A randomised controlled trial~      Elimination has become the goal of malaria programmes in an increasing number of endemic~     countries and regions. As resistance against artemisinin compounds has recently started to~     emerge in South-East Asia, there is a clear need to develop alternative malaria drug~     combinations. Adding another anti-malarial with a short half-life such as methylene blue to~     standard ACT could be a strategy to prevent artemisinin resistance development. Moreover,~     adding a gametocytocidal drug to ACT reduces the probability of transmission of P.~     falciparum parasites including drug-resistant parasites.~      Objectives: The primary objective of this trial is to investigate the safety of artesunate~     (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young~     children with uncomplicated falciparum malaria in Burkina Faso.~   "
15754|NCT02851095|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR)~     tablets co-administered with canagliflozin in healthy fed and fasted participants.~   "
15755|NCT02851082|"~     Physical activity is lower in patients with haemophilia than in their healthy peers.~     Nevertheless, exercize is recommended for those patients and supported by evidence. Until~     2013, scientific and medical evidence to encourage physical activity for patients with~     haemophilia were listed to increase their locomotor function, their metabolic status, their~     fitness level and their well-being. In 2013, an original publication by Groen et al.~     suggested that physical activity could also interact with the specific and biological~     disturbance of the disease.~      We propose to consider that regular endurance exercize prescription should be encouraged in~     patients with haemophilia not only for a healthier lifestyle but also because it could~     positively alter the specific biological blood disturbance seen in haemophilia.~     Nevertheless, before planning a well powered intervention trial we need to determine the~     acceptability of regular exercize and the expected value of factor Factor VIII, von~     Willebrand factor and von Willebrand propeptide after an endurance training program.~   "
15756|NCT02851069|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
15757|NCT02851056|"~     The purpose of this study is to test what effects (good and bad) a new cancer vaccine will~     have on participants and their cancer, when administered before and after their autologous~     hematopoietic cell transplant (HCT).~      The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is~     made using the participant's own blood cells. The vaccine will contain a virus called an~     adenovirus, similar the virus that causes the common cold. The virus has been changed so it~     cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer~     Center in the Cell Therapy Laboratory Facility.~   "
15759|NCT02851030|"~     Increasing physical activity (PA) and limiting sedentary time are important for many aspects~     of a young child's wellbeing. However, young children's PA is often limited, and instead~     preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more~     than 7 million U.S. children younger than 5 attend center-based child care, the early care~     and education (ECE) setting is an important source of PA for young children. Thus, PA~     promotion efforts in ECE programs are crucial to increasing the activity levels of young~     children, although few interventions exist and most have limited success.~      Classroom teachers are important gatekeepers to physical activity in ECE classrooms, as they~     can determine how active children are in their care. However, teachers often hesitate to~     implement physical activity in their classrooms. Teachers' attitudes about PA, confidence in~     modifying children's PA, and their own physical abilities can influence the amount of~     activity they provide and how they interact with children to support PA. Few models exist to~     enhance teachers' skill in promoting children's activity, although such an approach could~     result in more sustainable outcomes. Innovative approaches to physical activity promotion~     are needed, which engage teachers through training, ongoing technical assistance, and~     easy-to-use resources.~      This project aims to improve children's physical activity through the Move, Play, Learn!~     intervention, an intervention designed to alter the behavior of classroom teachers to~     increase PA in children (3-5 years old) enrolled in ECE programs through a novel, behavioral~     coaching approach.~      To evaluate the 10-week intervention, 32 classrooms in ECE centers will be recruited and~     randomly assigned to the Move, Play, Learn! intervention or a waitlist control. Teachers in~     the intervention arm will attend training workshops to learn how children's activity can be~     increased using natural opportunities across the child care day and how teacher engagement~     with children can impact activity outcomes. Teachers will be asked to modify typical~     classroom activities to be more active, using strategies and resources (e.g., how-to videos,~     pocket activity cards) and will be asked to modify their interactions with children to~     support PA. Goal setting, self-monitoring, and tailored feedback will facilitate behavior~     change.~   "
15760|NCT02851017|"~     Balance training is an important component of physical fitness, however due to the mundane~     and often repetitive nature of balance training alone this is often forgotten about and as a~     result people may be more susceptible to postural control instabilities. A potential~     solution to the mundane aspect of balance training is the use of exergaming (interactive~     exercise and gaming combined) through the use of commercial gaming systems such as the~     Nintendo Wii, Dance Dance Revolution (DDR) and more recently the XBOX Kinect. The aim of the~     investigation was to assess the XBOX Kinect versus traditional balance training on postural~     control, flow and technology acceptance.~   "
15761|NCT02851004|"~     This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy~     and safety of BBI608 in combination with pembrolizumab in patients with metastatic~     colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.~   "
15762|NCT02850991|"~     Definitive chemoradiation is the standard treatment for locally advanced esopahgeal cancer.~     NCCN recommends radiation dose of 50-50.4Gy as the definitive radiation dose for esophageal~     cancer with definitive chemoradiation. However, as many studies in China showed that the~     most common recurrence site after definitive chemoradiation was within the radiation region.~     But there have not been large randomized clinical trials to investigate the optimal~     radiation dose with concurrent chemotherapy for esophageal cancer in China. The purpose of~     this clinical trial is to investigate the optimal radiation dose for thoracic esophageal~     squamous cell cancer with definitive concurrent chemoradiotherapy.~   "
15763|NCT02850978|"~     Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with~     COPD in real-world setting~   "
15764|NCT02850965|"~     To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in~     patients with moderate to severe chronic plaque psoriasis.~   "
15765|NCT02850952|"~     To determine whether implementation of Rehab MATRIX will improve patient safety, patient~     satisfaction and nursing indices.~   "
15766|NCT02850939|"~     Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all~     breast cancer patients with hormone receptor-positive tumors, which represent 75% of all~     breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the~     risk of death nearly in half during the second decade after diagnosis, research shows.~     Despite the proven benefits, about 33% of women who are prescribed EHT do not take their~     medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk~     of recurrence and death.~      This educational randomized controlled study will develop and pilot-test a bilingual,~     culturally tailored, personalized, interactive mobile application (app) in combination with~     patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT)~     among breast cancer patients.~   "
15767|NCT02850926|"~     This study will determine if protective soccer headgear reduces the incidence or severity of~     Sport Related Concussion injuries (SRCs) in US adolescent (high school) soccer players. Half~     the subjects will practice and play during their soccer season with soccer head gear~     specifically marketed to reduce the incidence of SRCs while the other half of the subjects~     will practice and play without the head gear.~   "
15768|NCT02850913|"~     Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children~     in Africa. A number of toxic, nutritional, infectious, para-infectious and environmental~     causes have been studied but the only consistent association has been with infection by the~     parasite Onchocerca volvulus. There is no specific treatment for NS and also for the adult~     onchocerca. However, antibiotic depletion of the Onchocerca volvulus co-symbiotic bacteria~     Wolbachia with tetracyclines such as doxycycline results in sterilisation and premature~     death of the adult worm and marked reductions in dermal microfilaria density. Potentially,~     such therapy that kills adult onchocerca volvulus may improve the outcome of NS if the~     association were true.~   "
15769|NCT02850900|"~     Response to psoriasis treatment is variable in large part because of poor adherence~     treatments. Studies using electronic monitors have assessed adherence to topical and~     injectable psoriasis treatments and to biologics, yielding critically important insights.~     Adherence to oral psoriasis treatments is not as well characterized but is also critical, as~     the therapeutic windows for these treatments are narrower than for other psoriasis treatment~     options.~      The proposed study will assess patients' adherence to oral psoriasis treatment (primarily~     methotrexate) and will also collect pilot data on an intervention to improve adherence. The~     primary hypothesis of the investigators study is that adherence to oral psoriasis treatment~     is poor and that a reporting intervention may improve adherence to oral psoriasis treatment.~     In the investigator-blinded, 6-month prospective study, patients will be randomized to~     standard-of-care treatment or standard-of-care supplemented with the weekly online reporting~     intervention. Adherence will be assessed using electronic monitors. This randomized trial~     will permit the investigators to determine adherence to oral psoriasis treatment, assess the~     relationship between adherence and psoriasis outcomes, identify factors that are associated~     with adherence to oral psoriasis treatment (including physician trust, confidence in the~     treatment plan, and depression), and obtain preliminary data on the impact of an~     Internet-reporting measure on patients' adherence to oral psoriasis treatment~   "
15770|NCT02850887|"~     The aim of this study is to determine the effect of airway management (a set of medical~     procedures performed to prevent airway blockage and thus ensure an open path between a~     patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography~     [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and~     the effect on airway complications (problems), time to biliary cannulation (access into bile~     duct) and total procedure duration (length of time). Two methods are being compared and~     studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks~     pain) technique in which anesthetic and respiratory gases pass through a tube placed in the~     trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation:~     local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that~     treats pain) only.~   "
15771|NCT02850874|"~     This single-center, prospective proof-of-concept study is designed to evaluate the surgical~     outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal~     chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT;~     neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients~     having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk~     clinical features. The investigators hypothesize that HIPEC administered in this clinical~     course will reduce postoperative peritoneal disease recurrence. The investigators also~     expect that local recurrence of disease will be reduced. The primary aim of this study is to~     compare 2-year peritoneal disease-free survival between patients receiving the experimental~     therapy (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy~     (SCT + PD). Secondary aims are to determine the clinical feasibility and outcomes of~     neoadjuvant HIPEC for resectable PDAC using patient demographics and disease characteristic~     data.~   "
15772|NCT02850861|"~     In condylar fracture surgery, reduction is the most difficult step and the key factor which~     determined the postoperative outcome. Therefore, the aim of this study is to develop a new~     instrument, which the investigators call condylar redactor, to assist the surgeon to reduct~     the condylar segments effectively.~   "
15773|NCT02850848|"~     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test~     Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an~     Equivalent Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy~   "
15774|NCT02850835|"~     Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality~     of life, daily activities and sexual function. Latina women are disproportionally affected,~     with significantly higher rates of POP compared to women of other ethnicities. Decision aids~     have been used to increase patient knowledge prior to physician intervention and to~     facilitate informed patient participation on treatment selection. The investigators~     hypothesize that the use of a video decision aid prior to initial Urogynecology specialist~     evaluation of Latina women with POP in a border region university-affiliated medical clinic,~     will increase patient knowledge regarding the condition, decrease decisional conflict~     regarding selection among different treatment options and increase patient satisfaction with~     selected treatment.~   "
15775|NCT02850822|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess~     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome~     (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and~     AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in~     discussion. In this study, the safety and efficacy of chemotherapy and no chemotherapy~     pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow~     blast cells less than 50%) undergoing allo-HSCT are evaluated.~   "
15776|NCT02850809|"~     Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell~     carcinoma treated by Radiofrequency ablation. All patients will be included consecutively~     and retrospectively in all centers to obtain the required number of patient followed during~     5 years.~   "
15777|NCT02850796|"~     This study aims to test the efficacy and feasibility of an acceptance, mindfulness and~     compassionate-based intervention for women with overweight and obesity without binge-eating~     disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster~     fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's~     University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma~     and unhealthy eating behaviours and promote quality-of-life by targeting weight-related~     experiential avoidance and self-criticism patterns. The intervention focuses on fostering a~     greater awareness and ability to be in contact, tolerate and accept all internal experiences~     (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than~     trying to avoid, control or change them. Additionally, the intervention intents for~     participant's to develop a compassionate attitude towards themselves, especially during~     challenging times in order to decrease shame and self-criticism.~   "
15778|NCT02850783|"~     Rationale: Lymph node status is the most important factor in the selection of patients for~     adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30%~     stage I/II patients with negative lymph node involvement will develop distant metastases and~     eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of~     the lymph nodes could contribute to a better survival of colon cancer patients. This~     sentinel lymph node (SLN) procedure aims to identify the first draining lymph node(s) from~     the primary tumour, which have the highest risk of harbouring metastases. These SLNs can be~     pathological analysed with several more sensitive histopathologic techniques like~     immunohistochemical staining (IHC).~      Objective: Aim of this study is to investigate if the combination of a radioactive and~     fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node~     mapping (SLNM) technique in colon cancer by utilizing the radioactive component for~     preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component~     for guidance to the SLNs during surgery.~      Study design: Single centre pilot study Study population: Ten patients with colon cancer~     (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3,~     scheduled for laparoscopic surgical resection of the tumour.~      Intervention (if applicable):~      The present study will be performed with the radioactive tracer 89Zr-Nanocoll and~     fluorescent tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the~     radioactive tracer 48 hrs before surgery. After injection, patients will undergo the first~     PET/CT scan. A second PET/CT scan will be performed ± 24 hrs after tracer injection and a~     third scan just before the surgical procedure; ± 48 hrs after tracer administration. During~     the surgical procedure ICG diluted in saline and human albumin will be injected at the base~     of the tumour by colonoscopy. The PET/CT images will be compared with respect to the total~     number and location of foci and , if visible, lymphatic vessels. During surgery the~     fluorescent nodes will be marked with a suture in vivo. Thereafter the PET/CT images will be~     used as a roadmap, to detect SLNs which are not visible with the NIR laparoscope. These~     nodes will be marked with a suture too. When all radioactive and/ or fluorescent nodes are~     detected, the specimen will be resected like the conventional method. Ex vivo the specimen~     will be inspected for fluorescent and/or radioactive nodes not found in vivo. All the~     identified nodes will be taken out ex vivo and stored separately. The entire specimen will~     be submitted for pathologic examination. All identified SLNs will be stained with~     hematoxylin-eosin (H&E). If the fluorescent or radioactive SLNs are negative after routine~     H&E staining, they will be sliced in multiple parts and examined with H&E staining and~     immunohistochemistry with the specific marker CAM5.2. Finally, the pathologist uses~     palpation to identify the remaining non-fluorescent and/ or radioactive lymph nodes. Nodes~     found by palpation will be screened for fluorescent and/ or radioactive activity too.~      The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an~     interactive video morphometry system (Leica, Cambridge, UK).~      Main study parameters/endpoints: Main study parameter is the identification rate of SLN~     mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR)~     fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics~     of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are~     the number and localization of the SLNs and optimal tracer volume.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All participating patients will receive conventional resection of the tumour~     and follow-up according to normal standards in our hospital. The main goal of this study is~     to optimize the SLN mapping technique in colon cancer. If the investigators are able to~     identify the true SLN this could lead to better staging and survival of patients with this~     type of cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the~     hospital will be prolonged with one day. The additional risks of exposure to radiation for~     participating patients are calculated and can be considered as negligible.~   "
15779|NCT02850770|"~     The objective of this study was to investigate the feasibility, perceived usefulness, and~     potential effectiveness of a short text or voice message intervention to activate 1)~     physical activity behavior change among low-income, urban, Latino patients in diabetes~     management and 2) supportive behaviors by family members or close friends.~   "
15780|NCT02850757|"~     This study will compare the efficacy of modified William's airway versus U shaped Guedl's~     airway in assistant of fiberoptic bronchoscope during endotracheal intubation~   "
15781|NCT02850744|"~     PQR309 is an oral, dual pan-PI3K (phosphatidylinositol 3-kinase phosphoinositide 3-kinase)~     and mTOR (mammilian target of rapamycin) inhibitor that penetrates the blood-brain barrier~     at pharmacodynamically active concentrations. This study plans to evaluate PQR309 in~     treatment of patients with first progression of glioblastoma.~   "
15866|NCT02849730|"~     In this retrospective study, postoperative pain score, epidural patient controlled analgesia~     (Epi-PCA) related complications, the risk factors for requirement of rescue analgesics and~     antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl~     and ropivacaine-based Epi-PCA during postoperative 48 hours after various surgeries.~   "
15867|NCT02849717|"~     The purpose of this study is to see whether exercise can improve the health and well-being~     of patients scheduled to undergo surgery for a bowel related condition.~   "
15782|NCT02850731|"~     Highly diversified programs of physical activity in older people have shown their~     effectiveness in terms of improving functional capacities. Only one of these programs, to~     date, has used a motorized platform. The motorized platform allows the use of sensorimotor~     programs adapted to this population. Thus, for the user, a combination of motor and sensory~     capacities necessary to actively control different positions as well as reactions to~     maintain balance are stimulated, and are as important as psychomotor capabilities to~     maintain autonomy and the fight against losing independence.~      Demonstration of the effectiveness of this type of equipment would propose a new modality of~     physical activity adapted to this population. Use of this new equipment could allow the~     possibility of standardizing this activity, whilst continuing to individualize physical~     activity programs.~      Two phases for each group (Intervention/Control):~      Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group)~     or an adapted physical activity program (Control group) under supervision of a therapist who~     will adapt the program according to the progress of the patient, following a standardized~     procedure (exercises: postural/balance training, strength training for the legs/trunk and~     coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program~     at home for both groups, performed independently.~      Blinded evaluations will be performed at 6 weeks and at 6 months for each group.~      The investigators hypothesis is that the use of the motorized platform will allow superior~     physical performance compared to a traditional physical activity program.~   "
15783|NCT02850718|"~     A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test~     sublingual sildenafil wafer.~   "
15784|NCT02850705|"~     Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor,~     based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from~     multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore,~     NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort,~     including not only NMO but also clinical syndromes suggestive of a first episode~     (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer~     questions that could not have been addressed at the level of a single centre.~      Objectives: The main objective is to describe the clinical, radiological and biological~     features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse~     myelitis (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their~     evolution. The second aim is to create a biobank dedicated to NMO (serum, whole blood for~     RNA and DNA extraction, cerebrospinal fluid), to promote translational research in the~     field. Methods: NOMADMUS is a prospective, multicentre, observational study of patients~     NMOSD and related disorder in France. Prevalent cases are included retrospectively and then~     followed prospectively. Incident cases are included from disease onset and followed~     prospectively. A minimal set of data has been defined and synthesized on specific paper~     forms derived from the European database for multiple sclerosis (EDMUS) forms. Patients are~     systematically tested regarding their AQP4-IgG and MOG-IgG status. All the data are~     centralised in a EDMUS-derived database in Lyon, the EDEN software. All cases are validated~     and classified by an expert committee.~   "
15785|NCT02850692|"~     Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of~     patients: its main manifestation is the development of portal hypertension (PHT). The~     pathophysiology of this comorbidity is still poorly understood. It was previously considered~     secondary to the formation of biliary cirrhosis but another hypothesis would be that of a~     primitive pathology of venous vessels may cause the gradual emergence of portal hypertension~     without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a~     specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane~     conductance Regulator) protein is expressed on the surface of endothelial cells. The~     investigators hypothesize that liver disease related to PHT−associated cystic fibrosis is~     associated with systemic endothelial dysfunction.~      The aim is:~      To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when~     associated with PHT.~      To study the correlations between measures of systemic endothelial function and serum~     markers of endothelial dysfunction and between measures of liver stiffness and systemic~     endothelial function.~   "
15786|NCT02850679|"~     This is a retrospective multi-center patient cohort study investigating patients with~     persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify~     clinical predictors for ineffective ECV to improve management quality of persistent AF.~   "
15787|NCT02850666|"~     This is a one-group, pre-post feasibility study of an intensive, interdisciplinary (theatre,~     Occupational Therapy (OT), and Speech Language Pathology (SLP)) intervention targeted at~     social skill development in children, aged 3-4. The intervention uses process drama modified~     with OT and SLP techniques and using typically developing peer models. Feasibility outcomes~     are recruitment rates, retention rates, daily program records of ease of implementing~     program, and record of modifications needed. Child primary outcomes are Social Skills~     Improvement Scale (SSIS), Theory of Mind (T0M) Battery and Inventory, Structured Play~     Assessment (SPA), and Communication and Symbolic Behavior Scales (CSBS) scores within 4~     weeks of program end. Secondary outcomes are brain activity in frontal lobe and~     temporal/parietal areas measured by high density EEG within 4 weeks of program end, parental~     interview at 3 months related to child's social skills, and observational data on social~     skills during the program.~   "
15788|NCT02850653|"~     Endophthalmitis is a serious eye infection of exogenous origin (post-operational,~     post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic~     emergency.~      Each patient suffering from endophthalmitis must have immediately an ocular sampling, an~     intra ocular injection of antibiotics and a systemic antibiotic cover.~      The etiological treatment will be adapted according to the infectious agent.~   "
15789|NCT02850640|"~     Cost and Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS),is a~     cohort study which aims to capture health care utilization, cost, and quality of life~     indicators of patients with advanced cancer and their primary caregivers.~   "
15790|NCT02850627|"~     The purpose of this study is to test the expression of microRNAs related to the syndromes~     after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the~     effects of Tongguan capsule, and provide the biological foundation of curative effect of~     Tongguan capsule.~   "
15791|NCT02850614|"~     Juniors and seniors will be recruited to participate in the study, which will begin in the~     fall 2016 and run through May. The intervention will be a randomized-controlled trial, where~     students are randomized to either a control or incentive condition. Physical activity will~     be automatically tracked throughout the study period using FitBit activity trackers~     wirelessly linked to the gaming application on students' Chromebooks or mobile phones.~     Students who achieve 30 minutes of MVPA during the school day and/or 60 minutes of MVPA over~     the entire day will receive in-game rewards moving them up leaderboards in the game,~     providing them with more game points, or allowing them access to more game elements.~     Baseline outcome measures will be collected at the beginning of the school year in the fall,~     and post-intervention outcome measures will be collected in May.~   "
15792|NCT02850601|"~     The objective of this single center, 4-week, open label randomized, phase II study is to~     evaluate and characterize the tolerability and clinical effectiveness of dexamethasone~     0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen~     planus.~   "
15793|NCT02850588|"~     The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of~     stents placed directly into the carotid artery while reversing blood flow within the carotid~     artery to reduce stroke risk. It will compare this less-invasive surgical procedure with~     standard carotid endarterectomy in centers that participate in the Society for Vascular~     Surgery Vascular Quality Initiative.~   "
15794|NCT02850575|"~     This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough~     IMAGIKA technology.~   "
15795|NCT02850562|"~     The objective of this study is to test the effects of a healthy diet & walking (Controls)~     compared to a healthy diet, walking, and balance/strength exercises (Intervention) on muscle~     density in two populations: elderly individuals and obese individuals. The intervention will~     be 3 months in length. During this time, both Control and Intervention groups will meet one~     time each week for educational sessions on healthy diet strategies and to participate in a~     group walk for the Control group or group exercises for the Intervention group. The Control~     group will be asked to walk on their own an additional 4 times per week (5 times total) for~     at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month~     time point. The Intervention group will walk two times per week using the same criteria as~     above, and in addition will do balance/strength exercises on a total of three days per week.~     Measurements will be made at baseline, at intervention completion (3 months) and at a~     follow-up (6 months -3 months after completion of the intervention). At 3 months, the~     control group will be invited to add the balance/strength exercises.~      The hypotheses are that adding balance & strength exercises to a healthy diet plan will~     increase muscle density (decrease fat infiltration) and improve muscle function in the~     elderly and in the obese populations. Increases in muscle density are expected to show~     greater improvements in muscle function in the elderly population, while it is speculated~     that greater improvements in metabolic measures will show in the obese population.~     Participants in the intervention group will have a greater reduction in falls and less~     hospital, ER & clinic visits compared to the control group, but both groups will have an~     improved quality of life, positive changes in eating behaviors, and decreased perceived~     stress.~   "
15796|NCT02850549|"~     The purpose of this study was to assess if pain and function in patients with neck pain is~     less when physical therapists use a classification system.~   "
15797|NCT02850536|"~     This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered~     via the hepatic artery using the Surefire Infusion System (SIS) for patients with~     CEA-expressing liver metastases.~   "
15798|NCT02850523|"~     Anxiety Disorders (AD) are a serious mental health concern, affecting up to 15% of perinatal~     women. AD often coexists with depression and result in high distress and an impaired ability~     for new mothers to take care of themselves and their babies. In spite of the high prevalence~     of AD during pregnancy and postpartum, research and clinical attention in this area is~     lacking and no know empirically supported psychological treatments exist. Further, since~     many perinatal women are unable to choose not to take medication for their mental health~     symptoms, establishing an effective non-pharmacological alternative is imperative.~     Cognitive-behavioural therapy (CBT) is a well-established psychological treatment for mental~     health disorders, with noted moderate to large effect sized (.5-1.3). The investigators have~     recently developed a novel CBT treatment program for perinatal women with AD and ran an~     initial pilot study thereafter. A significant reduction in symptoms of anxiety and~     depression was found, along with reported high levels of treatment satisfaction. The purpose~     of the current study is to confirm the effectiveness of this treatment using a larger sample~     in the form of a rigorous randomized controlled trial (RCT).~   "
15799|NCT02850510|"~     Aim of study:~      To evaluate the effects of the shortened version of the Incredible Years (IY) Basic~     programme, the study which the parents were recruited to. A randomising experimental control~     between-group design was used with pre- and post-intervention measurements, and a one-year,~     four-year and ten-year follow-up. Children and families were randomized to either the~     shortened basic version (n = 89), or the control group (n = 97).~   "
15800|NCT02850497|"~     Aim of this study is to compare at 6 months follow-up, endothelization and malapposition,~     evaluated by means of optical coherence tomography, in terms of number of struts not~     endothelized or malapposed, after the implantation of three new generation stent: Cre8,~     Biomatrix and Xience.~   "
15801|NCT02850484|"~     The objective of this pivotal study is to evaluate the relative bioavailability of SYN010~     HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.~   "
15802|NCT02850471|"~     TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI)~     and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint~     stimulation protects against postoperative pulmonary complications in patients who are~     receiving mechanical ventilation during general anesthesia for gynecologic laparoscopic~     surgery.~   "
15803|NCT02850458|"~     The purpose of this study is to evaluate the clinical results of implant-retained mandibular~     overdentures in edentulous patients.~   "
15804|NCT02850445|"~     Regular psychosocial intervention combined with antipsychotic drugs, compared with usual~     medication alone treatments, can reduce psychiatric symptoms and improve quality of life in~     patients with schizophrenia. However, it's expensive, time-consuming, and sometimes~     inconvenient for patients and their family members in developing areas where the number of~     well-trained therapist remains limited in local psychiatric settings. The investigators~     aimed to establish an efficient model of integrated treatment (IT) for patients with~     schizophrenia. The procedure contains two stages: a centralized treatment during~     hospitalization and the following consolidation treatments with long intervals.~   "
15805|NCT02850432|"~     The aim of this study is to establish a clinically feasible simultaneous evaluation of heart~     and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI~     imaging markers in the evaluation of PAD and prediction of treatment outcome.~   "
15809|NCT02850380|"~     The purpose of the study is to investigate spatial orientation in weightlessness as it~     manifests not in perception but rather in motor performance by direction and reaction time~     of flip switch.~      Hypotheses are that flip switch:~        1. will be biased towards visual allocentric cues when those are available;~        2. will be biased towards the egocentric reference when tactile cues are added;~        3. will be dominated by egocentric cues when visual cues are not available;~        4. will be delayed and more variable when confirmatory gravitational cues are absent;~        5. will be faster and more reliable in absence of conflicting gravitational cues, and even~          more so when tactile cues are added;~        6. The difference will be more pronounce when tested under Dual-task condition~   "
15810|NCT02850367|"~     NO is an ubiquitous molecule contributing to many physiological functions such as~     vasodilation, immune and oxidative stress responses. NO production can be supplemented~     either by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by~     providing nitrate which can lead to NO. In the present project the investigators evaluate~     the effect of various acute and chronic oral NO precursors supplementation on exercise~     performance and responses in healthy young and older subjects.~   "
15811|NCT02850354|"~     The regulation of the cardiovascular respiratory system after changing environmental~     conditions or changes in work rates are essential for cognitive as well as physical~     functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs~     cardiovascular function that may cause loss of consciousness. Some anti-g maneuvers, such~     as muscle contraction of the lower extremities and buttocks or intermittent exhalation on~     exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance~     to high +Gz.~      Main objective of this experiment is to investigate the effects of anti-g maneuvers on~     cardiovascular and respiratory tolerance to the push-pull-effect.~      Cardiovascular and respiratory functions will be evaluated with the following parameters:~     heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide~     output, ventilation, breathing frequency, body core temperature.~      Electromyography (EMG) will not be a judgment criteria but will be used to check the quality~     of 'muscle contraction' anti-g maneuver.~      The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory~     tolerance to the push-pull effect, especially when they are combined.~   "
15812|NCT02850341|"~     The purpose of this study is to determine if the use of pedometers can help depressive~     inpatients in psychiatric clinics to increase their level of physical activity. Therefore~     patients are given a pedometer and instructions how to raise their level of daily steps.~     Intervention group is compared with a control group that is receiving treatment-as-usual.~     The intervention is hypothesized to increase number of daily steps and have positive effects~     on mood, depression and anxiety.~   "
15813|NCT02850328|"~     The aim of this study is to evaluate the applicability of high-load resistance training as a~     countermeasure for long term space flights, the current project has two scientific goals.~      The main objective is to perform a deeper examination of muscle function and MVC in~     weightlessness (parabolic flight).~      The secondary objective is to gather further insight into the underlying mechanisms and~     structures based on investigations targeting the neuromuscular and musculotendinous systems~     and their interaction.~   "
15814|NCT02850315|"~     The pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial~     infarction when deadlines are too long for primary angioplasty. Coronary angioplasty is then~     carried out within 3 to 24 hours following thrombolysis. The adjuvant antiplatelet therapy~     of thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). These~     clopidogrel doses are associated with a very low anti-platelet aggregation response within~     24 hours following administration. However, the antiplatelet agregation that inhibits the~     progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce~     the risk of thrombotic events. Intracoronary thrombus residual angiographic~     post-thrombolysis was associated with impaired myocardial reperfusion but coronary~     angiography has a very low sensitivity for detecting the thrombus. The optical coherence~     tomography (OCT) is currently the method of choice to visualize and quantify the~     intracoronary thrombus. It is used routinely in the presence of a thrombus to correctly~     estimate the size of the artery and for the evaluation of good stent apposition.~      The thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in~     case of major thrombotic mass. Intracoronary thrombus residual post-thrombolysis could be a~     marker for the quality of reperfusion itself correlated to the quality of the antiplatelet~     post-thrombolysis.~      The investigators therefore hypothesize that the systematic use of the OCT before elective~     angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the~     use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. Our study~     will also correlate the importance of the residual thrombus before angioplasty myocardial~     reperfusion one hand and to the inhibition of platelet activity observed other.~   "
15815|NCT02850302|"~     Breast cancer is a major public health problem. In France, it is the leading cause of cancer~     death in women. According to the National Cancer Institute (INCA), approximately 49,000 new~     cases were diagnosed in 2012 in France.~      It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior,~     biological and prognosis differ. Amongst these entities, the breast cancer triple negative~     (TN) is defined by the absence of expression of estrogen receptor and progesterone and the~     absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and~     occurs more frequently in young women. This is a very proliferative tumor phenotype with~     metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified~     molecular target, no targeted therapy has today shown benefit in terms of survival compared~     to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of~     this tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose~     (FDG) is a molecular imaging test that can identify from the first or second neoadjuvant~     chemotherapy treatment non-responder patients to treatment with low probability of~     pathologic complete response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET~     examinations should be performed; a) a pretreatment PET b) a control PET after one or two~     treatments. The objective of this pilot, single-center, prospective study is a preliminary~     identification of recurrent genomic alterations among triple-negative tumors with early~     chemoresistance, identified by PET in the first cycle of neoadjuvant therapy.~   "
15816|NCT02850289|"~     This multi-center, observational study will examine the clinical use and outcomes of~     pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in~     participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline,~     12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be~     required for participants with an HCV genotype other than 2 or 3. Quality of life data will~     be collected at baseline, and at each follow-up visit.~   "
15963|NCT02848391|"~     Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in~     normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to~     evaluate the impact of a flight simulation on walking endurance in these patients.~   "
15817|NCT02850276|"~     The purpose of this study is to explore a possible link between the autonomic nervous system~     and immune function in patients with HIV. Sometimes HIV can cause these nerves to function~     abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a~     condition that is different from person to person. In some people it causes no symptoms and~     is not harmful, in others it may cause symptoms such as dizziness or lightheadedness,~     nausea, vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN~     don't know that they have it. One of the important nerves in the autonomic nervous system is~     the vagus nerve. Abnormal function of the vagus nerve may cause stomach and intestinal~     slowing, which could lead to an overgrowth of bacteria. The body senses these bacteria and~     tries to fight them, leading to inflammation.~      In this study the researchers will test whether abnormal function of the vagus nerve in HIV~     is associated with stomach slowing and overgrowth of bacteria, and if a drug called~     pyridostigmine can help.~   "
15818|NCT02850263|"~     Intravitreal aflibercept has been approved for the treatment of visual impairments due to~     diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014~     respectively.~      The main objectives of this observational cohort field study are to evaluate effectiveness~     of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti~     vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine~     clinical practice in the United Kingdom.~   "
15819|NCT02850250|"~     -  To evaluate plasma concentrations of Cefuroxime in this patient population~        -  To determine if certain pathophysiological and/or iatrogenic conditions alter the~          pharmacokinetics in this patient group.~        -  To develop a rational physiological population pharmacokinetic model that describes~          plasma concentrations of medications in these patients.~   "
15820|NCT02850237|"~     Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest~     with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root®~     (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2~     (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support~     following most recent European Resuscitation Guidelines but with another monitor. Until now~     it is the only parameter which may predict return of spontaneous circulation. Because of~     this, researchers want to measure both with the same device, which gives the investigators~     the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very~     precisely. In this manner researchers want to investigate the predictive value of cerebral~     saturation and compare it end-tidal CO2.~   "
15821|NCT02850224|"~     In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines~     on cardiovascular health and risk reduction in children; among these guidelines were~     screening recommendations for obesity and obesity-related conditions. Following publication~     of this report there was a call for caution and for increased patient (parent, child) input~     on implementing these guidelines. There are limited current studies evaluating~     patient-centered outcomes (PCO) in the well-child setting, however, given the childhood~     obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI~     ranks first among 22 cities with data for the prevalence of overweight and obese youth~     (39.7%), making Henry Ford Health System, which is located in Detroit, MI, an ideal setting~     to study childhood obesity related research questions.~   "
15822|NCT02850211|"~     Selective cyclooxygenase (COX)-2 inhibitors are commonly used analgesics that provide~     similar analgesia but reduced adverse effects compared to other analgesics. However, few~     studies have been conducted on postoperative pain and tendon-to-bone healing. Here, the~     investigators investigated the effect of a selective COX-2 inhibitor on analgesia and~     tendon-to-bone healing following arthroscopic rotator cuff repair.~   "
15823|NCT02850198|"~     This research is primary to compare effectiveness of scalp electroacupuncture and scalp~     acupuncture on motor function of the upper limb(UL) in convalescence phase of ischemic~     stroke. The clinical research is a randomized controlled trial (RCT),consisting of two arms~     of scalp electroacupuncture group and sham sclp electroacupuncture group to value difference~     of upper limb function after 4 weeks. The result indicates that scalp electroacupuncture is~     more sufficient to alter function. The purpose is to value effectiveness of scalp~     electroacupuncture on motor function of the upper limb in convalescence phase of ischemic~     stroke.~   "
15824|NCT02850185|"~     The purpose for this study is to determine safety and effectiveness of the oxyhydrogen~     generator with nebulizer through an adjuvant therapy for the severe COPD patients in the~     stable phase.~   "
15825|NCT02850172|"~     The purpose of this stratified randomized controlled trial (RCT) is to test the effects of~     Walk, Eat, & Breathe on preserving patients' nutritional status, functional walking~     capacity, pulmonary function, and emotional well-being during the CCRT and surgery~     course.Additionally, effects to reduce treatment-related complications and length of~     hospital stay for esophagectomy will be evaluated between experimental and control groups.~   "
15826|NCT02850159|"~     The purpose of this study is to investigate the effect of dual-mode non-invasive brain~     stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS)~     over the primary motor cortex of the lower leg and anodal transcranial direct current~     stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in~     patients with Parkinson's disease (PD) with freezing of gait (FOG).~   "
15827|NCT02850146|"~     Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in~     the LEARN-Tau study. The study designed to evaluate the imaging characteristics of~     18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of~     18F-AV-1451.~      The study will run in parallel to the LEARN study. In this study, participants will undergo~     up three (3) 18F-AV-1451 PET scans over a 3 year period. Imaging visits will occur at the~     start, middle and end of the participant's participation in the LEARN study (corresponding~     to LEARN Visit 1, between Visit 4 and 6, and Visit 8).~      The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over~     time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older~     individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451~     and any side effects that might be associated with it.~      Site investigators, participants, and study partners will not be informed of the results of~     the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may~     be of potential medical concern will be provided for appropriate follow-up.~   "
15828|NCT02850133|"~     Background:~      Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases~     compared to the healthy population. Aerobic exercise training is one of the recommended~     treatments. However, literature regarding the effect of aerobic training on patients with~     SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum~     myokines immediately after exercise and after a training program among patients with SCI.~      Method:~      Male patients with SCI and age- and sex-matched healthy individuals were recruited.~     Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak~     exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic~     exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise~     physiology parameters, and serum myokine (myostatin, insulin like growth factor, and~     follistatin) concentrations were measured pre- and post-exercise in both groups, and were~     repeated in patients with SCI post-training.~   "
15829|NCT02850120|"~     Complications from mesh procedures (i.e. insertion of tension-free vaginal tapes (TVT),~     trans-obturator tapes (TOT) and suprapubic slings (SS)) used during surgical treatment of~     stress urinary incontinence have caused major concern around the world.~      The investigators aim to conduct a retrospective cohort study using administrative inpatient~     data from the Hospital Episode Statistics (HES) database to determine the complications of~     all first-time surgical mesh procedures in the treatment of stress urinary incontinence~     (SUI) in women treated in a National Health Service (NHS) hospital in England who were~     discharged from hospital between 1st April 2007 and 31st March 2015.~      The primary outcome measure is the number and types of complications (occurring~     peri-procedurally, within 30 days of the mesh procedure and those occurring during~     follow-up). Additional outcomes recorded include: the numbers and types of mesh procedures,~     including those with potentially confounding concomitant procedures.~   "
15830|NCT02850107|"~     This study is designed to collect information during a procedure that is routine care for~     treating a blockage in a blood vessel in the upper part of the participant's leg. This study~     is for data collection reasons to help doctors gain better understanding of the treatment of~     disease in the blood vessels of the legs. You will be treated with two devices that are~     routine, or standard of care, for your doctor to treat blockages in the blood vessel of the~     leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood~     vessel. Data will be collected to assess what length of time the blood vessel will be~     prevented from re-narrowing through twenty-four (24) months after the procedure.~   "
15831|NCT02850094|"~     The investigators propose a 24 week program to provide proof-of-principle evidence that~     financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more~     physically active.~   "
15832|NCT02850081|"~     The investigators hypothesize that pre-operative statin use is neuroprotective at maximal~     doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin~     doses for two weeks (12-18 days) prior to CEA using change in performance on a battery~     neuropsychometric tests as outcome measure. Study will recruit patients based on their~     preexisting statin regimen.~      The investigators hypothesize that in asymptomatic CEA patients: 1) Pre-operative statin use~     is neuroprotective against early cognitive dysfunction (eCD) and lowers the risk of early~     mortality. 2) Maximal doses may be essential in achieving optimal neuroprotection against~     eCD.~   "
15833|NCT02850068|"~     This study is to test a new treatment method, geniculate artery embolization (GAE), to~     reduce the severity of pain and disability caused by knee osteoarthritis.~   "
15834|NCT02850055|"~     Tinnitus is one of the most prevalent symptoms that causes more disability in patients with~     temporomandibular disorder (TMD). The present study postulates a possible link between~     temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and~     physiological relationship, proposing a physiotherapy treatment for the temporomandibular~     joint to improve tinnitus.~      The aim of the study is to evaluate the effectiveness of adding specific manual therapy to a~     multimodal physiotherapy treatment in patients with tinnitus and temporomandibular disorder.~   "
15835|NCT02850042|"~     This pilot study was designed to compare the effects of modified constraint-Induced therapy~     and occupation-based intervention to increase functional motor recovery in stroke~   "
15836|NCT02850029|"~     This is an international observational cohort study on current aminoglycoside practices in~     intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring~     data will be collected during the first week of aminoglycoside (tobramycin, amikacin or~     gentamicin) administration in different countries over a year. A minimum of ten consecutive~     patients will be enrolled at each site.~   "
15837|NCT02850016|"~     The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin~     alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals~     during an analytical interruption of ART.~   "
15838|NCT02850003|"~     Study designed to assess the safety and plasma PK of tretinoin and its metabolites from~     topically applied IDP-120 gel.~   "
15839|NCT02849990|"~     This phase II trial studies how well androgen receptor antagonist ARN-509, abiraterone~     acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate~     cancer that has spread from where it started to nearby tissue or lymph nodes before surgery.~     Androgen can cause the growth of tumor cells. Hormone therapy using androgen receptor~     antagonist ARN-509, abiraterone acetate, prednisone, degarelix, and indomethacin may fight~     prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of~     androgen by the tumor cells.~   "
15840|NCT02849977|"~     The purpose of this screening study is to identify people who have a rare genetic cause of~     obesity - specifically three genetic variants (a change in the DNA structure) of the POMC,~     PCSK1 and LepR genes that are currently known to result in obesity.~      This screening study will not include any investigational drugs. You will be asked to~     provide a DNA sample and answer some questions about your medical history and hunger.~   "
15868|NCT02849704|"~     The objective of this study is to evaluate the malabsorption blood test (MBT), stool~     coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential~     screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic~     insufficiency (RPF/PI). A further objective is to determine the test responses before and~     after pancreatic enzyme medication administration (Creon36™) in the patients with chronic~     pancreatitis (CP).~   "
15841|NCT02849964|"~     The REIN registry highlights significant disparities in the incidence of end-stage renal~     disease (ESRD) between regions, especially in the North East of France. According to the~     literature, the incidence of ESRD in an area could be related to contextual factors~     influencing the needs for dialysis or transplantation (age structure, prevalence of risk~     factors, socioeconomic and morbidity levels), as well as to primary and secondary care~     provision (general practitioners and nephrologists) and to practice patterns in nephrology.~      The aims of this project are the following:~        1. to compare the incidence of renal replacement therapy (dialysis or preemptive~          transplantation) for ESRD between the départements and the cantons belonging to the~          5 regions of Eastern France (Alsace, Lorraine, Champagne-Ardenne, Bourgogne and~          Franche-Comté), while taking into account differences in population sizes and spatial~          patterns of the data,~        2. to analyse the relations between incidence disparities and socioeconomic environment,~          geographic accessibility to primary and secondary care and medical practice patterns,~          after adjusting for morbidity and mortality rates (incidence of diabetes,~          cardiovascular mortality).~      This project will enable a better understanding of the mechanisms involved in the spatial~     variations of ESRD incidence, while disentangling effects related to the need from effects~     related to service supply in different socio-economic contexts. It will be possible to~     identify a lack of equity in access to renal replacement therapy if, after adjusting for~     need indicators, there were variations of incidence of ESRD related to availability of~     service or to socioeconomic context. Highlighting such effects would lead to search for~     corrective measures in collaboration with the different stakeholders.~   "
15842|NCT02849951|"~     The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on~     treatment is effective and safe for the induction of remission in ulcerative colitis~     patients refractory to standard treatment with mesalamine~   "
15843|NCT02849938|"~     The specific aims of the study are to:~        1. Assess the feasibility of a TytoCare telehealth device with remote audio/video~          connection for evaluation of children with medical complexity in the home environment.~        2. Evaluate the usability of a TytoCare telehealth device in transmitting real time images~          (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart~          and breath sounds)~        3. Compare the impact of the TytoCare telehealth device versus traditional telephone~          assessment on patient management and user satisfaction~   "
15844|NCT02849925|"~     This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent~     molars may be arrested by sealing using two different types of materials; a glass ionomer~     and a resin sealant. A Randomized controlled clinical trial was designed. Children between 6~     and 12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars~     were allocated to one of the two arms of the study. Clinical and radiographic lesion~     progression were the main outcome. Integrity of the material and retention were secondary~     outcomes. A follow up period of 24 months with check-ups at 6 and 12 months was considered.~   "
15845|NCT02849912|"~     Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have~     resulted in improved cure rates with a 5 year relative survival rate estimated at 55% and a~     5-year prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody~     to the standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine,~     and prednisone (CHOP) led for the first time to decline of the specific mortality.~      After treatment, patients with NHL experienced elevated risks for therapy-related leukemia,~     several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric~     diseases which impact on quality of life. However little is known concerning long-term~     toxicity of this class of new agents so called targeted drugs such as anti-CD20.~      The primary objective of this cohort study is to estimate long term toxicity in NHL patients~     (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare~     drugs consumption to that of controls (i.e. external analysis).~   "
15846|NCT02849899|"~     Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to~     increased morbidity and reduced survival of transplants and patients. Corticosteroids,~     anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major~     diabetogenic impact and greatly contribute to the increase in diabetes prevalence after~     transplantation.~      There are to date few studies concerning the pharmacological prevention of post-transplant~     diabetes. Hecking et al. have recently reported that a short treatment with insulin,~     administered immediately after transplantation, reduce the incidence of de novo diabetes~     one-year post-transplant. This study included 50 renal transplant patients and showed that a~     three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The~     occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.~      No further pharmacological strategy has been developed to date. Relevant experimental~     evidences suggest that gliptins could be used in the pharmacological prevention of~     post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4),~     which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric~     inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP~     concentrations which induce insulin secretion and inhibition of glucagon secretion. The~     gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood~     glucose, gliptins have pleiotropic effects including a protective effect on β cells and~     anti-inflammatory effect.~      The additional cost associated with new-onset diabetes after transplantation could be also~     significantly reduced by efficient prevention. A US study found that, for the period between~     1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2~     years after transplantation. Moreover, transplantation resulting in one of the best~     increases of patients' quality of life, its estimate is essential in the treatment~     evaluation of this population.~   "
15847|NCT02849886|"~     This study evaluates the frequency of occurrence, severity, and response to treatment by a~     chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the~     case of acute Graft versus Host Disease (aGvHD) occurring after the administration of~     T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and~     T-lymphocytes~   "
15848|NCT02849873|"~     The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac~     Cream.~   "
15849|NCT02849860|"~     Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant~     metabolites after topical dermal application of IDP-121 lotion.~   "
15850|NCT02848807|"~     Determine whether nutritional support with high protein ONS in adult oncologic patients in~     the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of~     systemic therapy.~   "
15851|NCT02848794|"~     The study is aimed to evaluate the efficacy and safety of Apatinib and Irinotecan in~     patients with recurrent high-grade glioma.~   "
15852|NCT02848781|"~     The current standard of care for ventricular tachycardia (VT) includes the use of medicine~     called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD)~     therapy. These treatments are used to terminate the irregular heartbeats and bring the heart~     back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the~     heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation~     procedure in addition to an ICD to treat their VT condition or risk of developing VT. This~     study aims to show that treating VT with catheter ablation, if performed preemptively at the~     time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to~     improved survival.~   "
15853|NCT02848768|"~     The purpose of this study is to validate of a predictive nomogram of response or resistance~     to targeted therapies in metastatic clear cell renal cell carcinoma~   "
15854|NCT02848755|"~     Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high~     risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive,~     inexpensive bedside tool and examinations can be repeated as often as necessary without~     major disturbance of vulnerable infants. The anterior and posterior fontanelles from~     excellent acoustic windows to examine the deep midline and periventricular regions of the~     brain.Some data demonstrated that cerebral palsy can be accurately predicted with US.~     However, cranial US is not very suitable for investigating cortical regions or structures in~     the posterior fossa. There is limited data for very preterm infants.The investigators aimed~     to measure ventricular index, cranial height, biparietal diameter and calculate brain volume~     in a huge number of infants.~   "
15855|NCT02847702|"~     The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of~     VM902A twice daily compared to placebo in subjects with moderate to severe chronic pain due~     to OA of the knee.~   "
15856|NCT02847689|"~     The purpose of this study is to examine whether playing recordings of a mother's voice to~     her infant while in the hospital nursery is an effective treatment for promoting healthy~     brain and language development in infants born preterm.~   "
15857|NCT02847676|"~     Our study aims to characterise a possible pluripotent cell population in the abdomen~     responsible for peritoneal adhesions. We therefore want to take samples from women~     undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and~     characterise them for markers of pluripotency.~   "
15858|NCT02849834|"~     The primary aim of this study is to evaluate the induction of sensory-motor cortex~     plasticity after motor cortex stimulation in healthy subjects, using laser-evoked~     nociceptive cortical potentials, and in chronic neuropathic pain patients using functional~     MRI. As a secondary goal, the project will analyse possible correlations between the~     magnitude of cortical plasticity and that of the pain-relieving effect.~      In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory~     cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a~     cross-over randomized study.~      Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4~     weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over~     randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI~     (motor activation) performed before the first rTMS session and the last day of each session~     of rTMS.~   "
15859|NCT02849821|"~     This is a prospective, controlled and observational study. Participants underwent a 3-hour~     exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level~     (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool~     samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent~     time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000~     m) can alter disease activity and can modulate a pro inflammatory reaction.~   "
15860|NCT02849808|"~     Corneal transplantation have been performed for several decades, follow-up time in some~     centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary~     considerably from center to center. These variations may be explained by differences in~     case-mix and surgical techniques used.~      The investigators aim to better understand the factors associated with long term graft~     survival.~   "
15861|NCT02849795|"~     Body composition analysis and especially body fat distribution in regions of interest~     (android and in particular intra-abdominal region) provides some information on the risk of~     cardiovascular disease. There is little data available on the body composition analysis in~     psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in~     particular data on fat distribution in regions of interest regarding the risk of~     cardiovascular disease.~      Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic~     properties that are interesting to explore in pathologies with a higher risk of~     cardiovascular disease like psoriasis or psoriatic arthritis.~      Adipokines have been investigated in psoriasis but fat tissue and in particular its~     distribution (android/visceral or intra-abdominal) has not been studied in parallel.~     Moreover, relation between adipokines and psoriasis area or severity has been studied but~     the relation between adipokines and cardiovascular risk factors has not yet been~     investigated.~      The aim of this study is to investigate relations between the body fat distribution,~     adipokines rates and the risk of cardiovascular disease of these patients.~   "
15862|NCT02849782|"~     This prospective monocentric open label trial was realized in the Laboratory of Clinical~     Functional Exploration of Movement at the University Hospital of Besancon. Cognitive~     evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine~     treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation,~     respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1.~      Fampridine was prescribed according to guidelines issued by the French Health Products~     Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement~     of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is~     recommended to evaluate improvement after 2 weeks of treatment. According to the~     practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine~     treatment), patients were classified into 2 groups: responders whose clinical status was~     improved and non-responders whose clinical status was not improved.~   "
15863|NCT02849769|"~     Following product approval, further confirmation of the MR Conditional Tachyarrhythmia~     Therapy Systems sensing and detection performance post MRI exposure will be obtained by~     actively monitoring de-identified device data obtained through the Medtronic CareLink®~     Network.~   "
15864|NCT02849756|"~     Estimate the future six months after the admission in an intensive care unit of the patients~     of 85 and more years old in terms of autonomy.~   "
15865|NCT02849743|"~     This research study will test if oxytocin, delivered by nasal spray, will promote weight~     loss in children and adolescents with Hypothalamic Obesity as compared to a placebo. The~     study is divided into two parts. During the first part, subjects will receive either~     oxytocin or placebo. In the second part, subjects will cross-over to receive the other~     treatment - either oxytocin or placebo. During study visits participants will do blood~     tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires.~   "
15900|NCT02849288|"~     The trial is designed to assess safety and feasibility of the Bigfoot Biomedical Type 1~     Diabetes Management System (T1DMS) in up to 50 participants in a closely monitored Clinical~     Research Center (CRC) environment.~   "
15869|NCT02849691|"~     Dipeptidyl-peptidase-4 (DPP4) is an important regulator of incretins and inflammation, and~     participates in the pathophysiological process of acute myocardial infarction (AMI). However~     clinical data of DPP4a in AMI patients is sparse. This study was to investigate the role of~     plasma DPP4 activity (DPP4a) in patients with ST-segment elevation myocardial infarction~     (STEMI) treated with percutaneous coronary intervention (PCI). This was a analysis of~     consecutive patients conducted at a tertiary referral center from January 2014 to October~     2015. The investigators included 747 STEMI-patients, treated with PCI from January 2013 to~     October 2015. Blood samples were collected immediately at admission. The patients were~     divided into four groups according to DPP4a quartile.~   "
15870|NCT02849678|"~     This research study is testing whether the local anesthetic lidocaine is as effective as~     ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve~     blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in~     this hospital for post-operative pain control for the past few years, thus has become the~     standard drugs used for this nerve block. Lidocaine has numerous potential advantages over~     ropivacaine, such as faster onset of action, better safety profile and greater~     anti-inflammatory action. Catheters placed near both sides of a patient's spine for~     postoperative pain control are called thoracic paravertebral nerve blocks and are a part of~     routine care. Through those catheters, a numbing medication, or local anesthetic, to block~     the transmission of pain from the surgical incision to the spinal cord, thus reducing pain.~     The research part of the study is whether subjects will receive either the local anesthetic~     lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine~     controls pain better and facilitates a faster recovery after abdominal surgery than~     ropivacaine.~      In this research study, the investigators will compare patient-reported pain scores, any~     additional pain medication requirements for adequate pain control, time it takes for bowel~     function to return to normal following surgery, as well as the incidence of any side~     effects, such as numbness and weakness, subjects may experience between those receiving~     lidocaine versus those receiving ropivacaine. The investigators will screen 100 patients and~     enroll 60 subjects into this study.~   "
15871|NCT02849665|"~     Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight~     newborn. The Kangaroo Position is the main feature of this method. The infant should be~     lightly dressed, in prone position and upright against the torax of the parents. Researches~     provides evidence that the Kangaroo Position induces an increase in myoelectric activity of~     preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo~     Position so that ocurr changes in electromyographic. An increase in electromyographic~     activity was observed after 24 hours or more of submission to the Position Kangaroo, however~     period lower of submission to the Position Kangaroo have not been evaluated yet. Also~     unknown are the physiological mechanisms that cause this muscle response. One hypothesis~     would be the increase in temperature caused by skin to skin contact which could improve~     circulation in small vessels with direct influence on the infusion and nutrition of muscle~     tissue. Objective: Evaluate the immediate effect of Kangaroo position in the~     electromyographic activity and microcirculation of preterm newborn. Method: It will be a~     randomized and controlled trial from August 2016 to February 2017 with newborn preterm~     admitted at the Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and~     exclusion criteria will be randomized into two groups: Kangaroo Group (experimental group)~     and Not Kangaroo Group (control group). The data of the electromyographic activity and the~     microcirculatory parameters will be assessed and recorded in three stages: before the~     Kangaroo position, one and three hours after of continuous submission in the Kangaroo~     Position (for the group of cases) and before the Kangaroo position, one and four after the~     three assessments (for the control group). In the control group, the preterm newborns will~     be not submitted to Kangaroo position until the completion of the last and third evaluation.~     The acquisition of the electromyographic signal will be conducted through an equipment~     electromyography Miotool 400® brand (Miotec Equipamentos Biomédicos - Brasil). To assess~     microcirculation will be used for the white light spectroscopy method through the drive~     moorVMS-OXY®. The project was submitted and approved by Ethics Committee for Research on~     Human Beings of IMIP (52381915.5.0000.5201). This study is part of a anchor project approved~     by Conselho Nacional de Desenvolvimento Científico e Tecnológico- CNPq (process~     458163/2014-7).~   "
15872|NCT02849652|"~     Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by~     2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3~     times greater than in the general population. Further, even the recent small decline in~     smoking rates that has been reported in the general population in the past decade has not~     occurred among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US~     are by individuals with a psychiatric disorder and the primary cause of death among~     Americans with an SMI is a tobacco-related disease.~      This cluster randomized trial will be conducted in 14 Philadelphia community mental health~     clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through~     Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators~     hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of~     adherence to guidelines for treating TUD will be greater among clinic personnel that receive~     the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention~     and at a 3-month follow-up, rates of client smoking cessation will be significantly greater~     in clinics that receive the ATTOC intervention than among clients treated with usual care;~     and 3) using non-inferiority testing, at the end of the intervention and at a 3-month~     follow-up, there will be no significant degradation in mental health functioning or QOL~     among clients who receive care at clinics that received the ATTOC intervention than among~     clients treated with usual care.~   "
15873|NCT02849639|"~     The study will examine the impact on cognitive reserve of a pharmacist-physician~     patient-centered medication therapy management intervention to address inappropriate~     medication use as identified by the Beers 2015 list. By bolstering cognitive reserve, this~     project will directly address the National Alzheimer's Project Act 2015 priorities serving~     to delay onset of symptoms in preclinical dementia. The results of this study will provide~     valuable insights on how to expand this intervention to reduce the prevalence and associated~     healthcare costs of symptomatic Alzheimer's disease.~   "
15874|NCT02849626|"~     This is an open-label, multicenter study with an extension phase to evaluate the safety and~     tolerability of an perampanel oral suspension when administered as an adjunctive therapy in~     children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or~     primary generalized tonic clonic seizures (PGTC).~   "
15875|NCT02849613|"~     Stroke is the second leading cause of death in the world population. When not fatal, stroke~     often results in disability, and secondary health problems affecting not only patients but~     also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE~     will focus on the clinical assessment of regenerative cell therapy to improve stroke~     recovery and patients quality of life.~   "
15876|NCT02849600|"~     This is a retrospective cohort study with two specific aims. The first aim focuses on the~     treatment outcome of different VPT protocols in young permanent tooth. The second aim is to~     determine if MTA is a suitable material in VPT and related factors potentially influencing~     prognosis.~   "
15877|NCT02849587|"~     This study was authorized by the California Legislature (Assembly Bill 266, the Medical~     Marijuana Regulation and Safety Act (73) to help with detection of driving under the~     influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis~     with either 0% (placebo), 5.9%, or 13.4% Δ9-THC at the beginning of the day, and then~     complete driving simulations, iPad-based performance assessments, and bodily fluid draws~     (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the~     subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship~     of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in~     terms of hours from initial use, (3) if saliva or expired air can serve as a useful~     substitute for blood sampling of Δ9-THC in judicial hearings and (4) if testing using an~     iPad can serve as a useful adjunct to the standardized field sobriety test in identifying~     acute impairment from cannabis.~   "
15878|NCT02849574|"~     To improve the management and risk reduction, it is essential to understand the evolution of~     the consumption of psychoactive substances, medicated or not in detention; it does not have~     at present no data on this subject. This work has as main objective to evaluate the~     development of substance use terms (goods and consumption practices) by the inmates between~     the period preceding their incarceration and their fifth month in detention.~   "
15879|NCT02849561|"~     With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio~     respiratory arrest is a public health issue.~      The goal of this study is to evaluate the pupillary light reflex measured by the dimension~     of the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest.~     By participating to this study, the patient get the same tratments and exams than in a usual~     managing cares.~      In addition of these events, the pupillary light reflex is studied as soon as the patient is~     accepted in the department, and then on the second day.~      Currently, the evaluation of the neurological becoming rely on a multimodal clinical and~     paraclinical approach.~      The study of the pupillary light reflex measured by the diameter of the pupil could be a~     prognosis factor of neurological evolution for patients in post cardiac arrest, so a~     reliable and available prognosis marker in patient care.~      The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the~     diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients~     after a cardiac arrest.~      Principal criteria of judgement is the percentage of the pupillary light reflex variation~     measured with Neurolight®, compared between two groups.~   "
15880|NCT02849548|"~     The purpose of this study is to examine effects of blocking the orexin system with~     suvorexant after exposure-based intervention for posttraumatic stress disorder (PTSD) on~     sleep, PTSD symptoms, and intersession habituation.~   "
15881|NCT02849535|"~     The rise of oral targeted therapies favors outpatient care of cancer patients but exposes~     them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to~     treatment, inappropriate management of side effects and interactions with other~     co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity)~     are all the more important that ambulatory monitoring of treatments prescribed at the~     hospital remains underdeveloped due to default of coordination between these two settings.~      Adverse drug reactions are a major concern, as such, and because they involve prescription~     changes (dose reduction, treatment interruption). This results in a decrease in the dose~     taken and a risk of loss of efficacy.~      In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher~     because the oral targeted therapies available in this indication have a safety profile~     marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to~     reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules~     are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with~     drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss~     of efficacy.~      The investigators propose to assess a program set up to secure drug taking by enhancing~     self-management of side effects and control of drug interactions by the patient. This~     program includes pharmaceutical visits and involves inpatient and outpatient (doctor,~     referent pharmacist and liberal nurse) professionals.~      The hypothesis of the study is that the PRISM care program will improve self-management of~     side effects by the patient, resulting in a relative dose intensity of oral chemotherapy~     improved compared to usual care.~   "
15882|NCT02849522|"~     This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS).~     This register enables us to collect data on the treatment of LUTS using prostate artery~     embolisation (PAE), and other surgical methods to answer the following questions posed by~     NICE in 2013:~        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?~        -  How does PAE compare with conventional surgical treatments? This will primarily be a~          surgical procedure called TURP (see below).~        -  Which patients would most benefit from PAE over the other treatment options? This is a~          pilot study, and the final register will contain data from roughly 100 patients for PAE~          and 100 patients for the other surgical interventions, allowing us to answer NICE's~          research questions, update NICE guidance documentation, and do further research with~          more patients if necessary.~      Our hypothesis is:~      • PAE produces significant improvements in the IPSS score 12 months post-procedure~   "
15883|NCT02849509|"~     The aim of this non-interventional study is to describe patient's perception of~     anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while~     suffering from atrial fibrillation (according to its approved indication in the approved~     dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K~     Antagonist (VKA).~   "
15884|NCT02849496|"~     This randomized phase II trial studies how well veliparib and atezolizumab work either alone~     or in combination in treating patients with stage III-IV triple negative breast cancer.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor~     cells to grow and spread. It is not known whether giving veliparib and atezolizumab either~     alone or in combination would work better in patients with triple negative breast cancer.~   "
15885|NCT02849483|"~     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies~     reported that ramosetron is also effective treatment of irritable bowel syndrome. The~     investigators examine the effect of ramosetron on postoperative bowel motility.~   "
15886|NCT02849470|"~     Purpose The primary objective of this study is to evaluate the safety and efficacy of the~     use of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction~     (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP) as compared with~     adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment~     of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).~      Assigned Interventions~        1. HD-PRP + Matristem Matrix (ACell)~        2. Experimental: HD-PRP + Emulsified AD-tSVF~        3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip~          Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway)~          Centrifugation technique to acquire concentrated platelets (per manufacturer's approved~          protocol) Healeon ACM Emulsification System that prepares microcannula harvested~          AD-tSVF for small needle (25g) retrograde threaded intradermal scalp injection.~      Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by~     Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration~     (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA,~     USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection~     in scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker~     system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic~     digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP +~     cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat~     Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection~     patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to~     concentrate Platelets via using manufacturer standard protocol~   "
15887|NCT02849457|"~     Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled,~     double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis~     Complex who are less than 6 months of age prior to the onset of their first seizure~   "
15888|NCT02849444|"~     A prospective, multicentre, post-authorisation observational study. The objective of this~     study is assess the response of renal function in clinical practice to anti-multiple myeloma~     therapy in patients with relapsed MM and CrCl <50 mL/min/1.73 m2.~   "
15889|NCT02849431|"~     This study explores the feasibility of a mindfulness-based intervention for people with a~     diagnosis of borderline personality disorder.~   "
15890|NCT02849418|"~     This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with~     neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not~     been adequately managed with medications for urinary incontinence due to NDO.~      This study consists of a screening phase up to 28 days followed by a double-blind Treatment~     phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either~     GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects~     who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment~     phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to~     receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since~     the previous treatment. The duration of overall treatment phases is 48 weeks. The total~     duration of participation for any subject will not exceed 52 weeks, including screening.~   "
15891|NCT02849405|"~     Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is~     known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an~     impact on the entire vascularization including the microvascularization. The retina is a~     nervous tissue that is supported by microvascularization. Therefore, systemic diseases that~     affect the nervous or the cardiovascular system are susceptible to have manifestations in~     the retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation;~     diameter and appearance of arterioles) have been suggested. A quantitative approach would~     strengthen the interpretation of these evaluations.~      The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the~     capacity to identify and quantify a variety of biomolecules specific to the retina and the~     optic nerve.~      The purpose of this pilot study is to determine if the MHRC has the capacity to detect a~     specific hyperspectral signature in the retinal arterioles of subjects suffering from~     arteriosclerosis.~   "
15892|NCT02849392|"~     Research investigating beneficial effects of regular pistachio feedings on body composition~     (BC) and blood lipids are limited, and there are no studies that have investigated the~     effects of feeding pistachios on bone density or membrane incorporation of fats. The purpose~     of this study is to examine the effects of pistachio consumption on body composition, bone~     density, markers of bone turnover, erythrocyte membrane incorporation of fatty acids, lipid~     status, inflammatory markers, dietary quality/micronutrients and satiety using a cross-over~     study with two 12-week treatment periods (pistachio added (20 percent of kcals) and a~     no-pistachio control diet), separated by 15-week washout period. The investigators will~     recruit 30 female students from Cal Poly, San Luis Obispo (CP-SLO) and female 30 students~     from Cal Poly, Pomona (CP-P) facilitating a collaborative project and using the expertise of~     both Dr. Laura Hall (CP-SLO) and Dr. Bonny Burns-Whitmore (CP-P). The investigators hope to~     show the health benefits of pistachios as part of an overall healthy lifestyle.~   "
15893|NCT02849379|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent tongue cancer.~   "
15894|NCT02849366|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent sarcoma.~   "
15895|NCT02849353|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent ovarian cancer.~   "
15896|NCT02849340|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent cervical cancer.~   "
15897|NCT02849327|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent pharyngeal cancer.~   "
15898|NCT02849314|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent laryngeal cancer.~   "
15899|NCT02849301|"~     Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the~     majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S.~     healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths~     are directly attributable to PTB.~      Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are~     drugs that can slow or stop labor contractions in the attempt to delay births preceded by~     PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with~     PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have~     advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no~     maintenance tocolytic agent has been shown to be beneficial in preventing PTB.~      The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin~     pessary compared to standard care in singleton gestations with arrested PTL and with short~     transvaginal ultrasound (TVU) cervical length (CL) <25mm~   "
15903|NCT02849249|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability~     of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea~     and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild~     asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level~     changes and skin reactivity.~   "
15904|NCT02849236|"~     Breast augmentation surgery can cause important postoperative pain, especially when~     bilateral subpectoral implants are used. The investigators hypothesized that a technique of~     regional analgesia, the pectoral nerve block type I (or PECS I block) would reduce pain~     within the first twenty-four hours and, in turn, morphine consumption and associated side~     effects. This is a randomized, controlled, double-blind study which compares intra and~     postoperative analgesia with or without PECS I block in breast surgery.~   "
15905|NCT02849223|"~     The primary aim of this study is to assess the magnitude of transcranial direct current~     stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic~     brain injury. This study will also attempt to identify biomarkers associated with treatment~     response. Last, acceptability and tolerability of procedures will be assessed. To accomplish~     these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will~     be conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation~     offered concurrent with working memory training. Neural efficiency will be measured with~     electroencephalogram (EEG) pre and post-intervention.~   "
15906|NCT02849210|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability~     of subcutaneous immunotherapy with Olea europaea pollen extract in patients with~     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity~   "
15907|NCT02849197|"~     Comparison of limited excision-primary closure, Limberg, and modified Limberg flap~     techniques for the surgical treatment of pilonidal sinus disease, each performed by a~     separate surgeon, in terms of postoperative outcomes and recurrence rates.~   "
15908|NCT02849184|"~     The purpose of this study is to compare the effectiveness and safety of suvorexant versus~     placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.~   "
15909|NCT02849171|"~     This is a pilot study. The purpose of this study is to test if an imaging tracer, not~     approved by the FDA, called 18F-Fluorocholine (18F-FCH) is useful for evaluating this type~     of cancer. This tracer is used to perform PET scans. The researchers want to see if the~     18F-FCH PET scan, using the study tracer 18F-FCH, can improve upon the usual scans at~     diagnosing or monitoring this type of cancer.~      In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true~     tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It~     is important to distinguish true tumor growth from inflammation since inflammation indicates~     the tumor is responding to treatment. With standard MRI, it is difficult to determine if~     changes following treatment are due to tumor growth or inflammation early on. Researchers~     hope to learn if the investigational tracer, 18F-FCH, will be able to distinguish true tumor~     growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.~   "
15910|NCT02849158|"~     Single center interventional study to explore activity of fibroblasts in the tumor and away~     in the healthy rectal tissue.~   "
15911|NCT02849145|"~     Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA~     rate in the blood, before and after curative resection of hepatic metastasis of uveal~     melanoma (HMUM) and during post-surgery follow-up~   "
15912|NCT02849132|"~     Patients who have completed 2-years entecavir-based treatment in Regress Study will receive~     another 5-years entecavir extension therapy. Patients will be assessed at baseline and every~     six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan; A third liver biopsy will be performed at year 3 in patients~     who have significant fibrosis at second biopsy. CT and endoscopy will be performed at~     baseline and year 3.~   "
15913|NCT02849119|"~     Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be~     performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less~     utilized than TP approach because of technical difficulties when using rigid laparoscopic~     instruments in the small space of retroperitoneum cavity. However, with advanced surgical~     skills and thoughtful patient selection, RP approach may be associated with shorter~     operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS)~     compared with TP approach.~      Therefore, the investigators performed randomized control trial to compare the outcomes of~     the two approaches (TP-LPN or RPN vs RP-LPN or RPN).~   "
15914|NCT02849106|"~     Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture~     3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this~     technique for treatment response in patients treated by two different chemotherapies (FOLFOX~     or FOLFIRI) for colorectal cancer.~   "
15915|NCT02849093|"~     The primary aim of the study is to investigate whether optical coherence tomography (OCT)~     may be a useful tool for investigating the in-vivo histology of ocular structures in~     patients with tear film pathology. In epiphora the investigators will image the proximal~     lacrimal system. In dry eye syndrome the investigators will image the lacrimal gland and~     also the buccal mucosa.~      The secondary aim of the study is to investigate the appearance of the normal cornea and~     conjunctiva under OCT imaging.~   "
15916|NCT02849080|"~     This trial is globally conducted. The aim of this trial is to investigate Efficacy and~     Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation~     versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.~   "
15917|NCT02849067|"~     It is known that laughter can bring benefits in terms of physiological and psychological~     parameters, in addition to improving the individual's quality of life. However, the~     literature is still scarce as to the existence of studies investigating the effects of a~     comedy film specifically in hemodynamics.~   "
15918|NCT02849054|"~     To determine the appropriate volume (size) of ventilator breath during volume-targetted~     ventilation for infants born with congenital diaphragmatic hernia.~   "
15919|NCT02849041|"~     Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the~     smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are~     carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is~     responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus),~     nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and~     some myeloid leukemias.~      This study aims to evaluate the combined effect of the scanner and the search for~     circulating tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers~     to cessation and addressing the psychological impact this approach.~   "
15920|NCT02849028|"~     Microbiome studies may be highlighted as crucial in the development of sleep disorder for~     TBI patients. The microbiota-gut-brain connection may further provide an opportunity for~     microbiota manipulation to treat the TBI patients with sleep disorders.This study is to~     investigate whether exist the relationship between sleep disorder and circadian rhythm of~     patients with TBI or not and focus the study on the potential of the host-microbiota~     interaction in regulating sleep disorder.~   "
15921|NCT02849015|"~     The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK)~     immunotherapy to tumors in transplanted liver.~   "
15922|NCT02849002|"~     The primary objective of this study is to collect un-blinded BrainPulse recordings from~     youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in~     order to improve a concussion detection algorithm previously developed by Jan Medical, Inc.~     Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to~     study the subject's recovery process. The symptomatic evaluation, physical examination, and~     BrainPulse recordings will be entered in a database to assess clinical outcome and device~     utilization.BrainPulse(TM)~   "
15923|NCT02848989|"~     Studies have shown that on-going pain following breast surgery is common and may limit the~     ability to participate in physical activity, cause tiredness, difficulty in daily~     chores/activities as well as other problems.~      This study is evaluating whether participating in a 12-week Qigong program (pronounced chee~     kung), an exercise program that involves gentle movements combined with breathing/relaxation~     techniques, also known as mind-body exercise, leads to improvement of pain, physical~     function, and quality of life among breast cancer survivors that have significant pain~     following surgery.~   "
15924|NCT02848976|"~     Regular physical activity promotes physical and mental well-being in the general population.~     Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity~     or because of deficiencies related to the disease, or even on the advice of their caregivers~     in order to save their functional abilities. Time for leisure activity could be almost 20%~     lower in MS patients compared to healthy controls, and this situation is likely to aggravate~     the functional symptoms of multiple sclerosis.~      The literature described the benefit of physical activity for MS patients according to~     protocols and varied assessments. Evaluations were indeed concern very analytical elements~     of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account~     the performance of components or fatigue and quality of life. Due to the multiplicity of RE~     protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the~     double issue was the profit earned by an RE program and of this benefit by level of severity~     of MS. The main objective of our study was an evaluation of the effects on fatigue and~     quality of life of a retraining program to effort suitable for levels of impairment and~     patients with MS activity limitations. The secondary objective was checking a performance~     improvement of the patients in this adapted program.~   "
15925|NCT02848963|"~     ASA I-II 3-12 years old children participated to this study. All Participants will divide~     into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at~     anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of~     ketamine-propofol mixture with %67 of Mcfarlan dose regiment.~      In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia~     induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol~     mixture with %80 of Mcfarlan dose regiment.~      In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction.~     General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90~     of Mcfarlan dose regiment.~      After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU~     will be recorded. These data will be evaluated with statistically.~   "
15926|NCT02848950|"~     The basis for obesity's impact on reproduction is not well characterised and there is a~     controversy whether the key organ influenced by it are the ovaries or the uterus.~      Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to~     determine if Metformin helps to increase fecundability by affecting the uterus in women~     undergoing ART. As a surrogate marker- flows in the uterus will be tested during the~     treatment.~   "
15927|NCT02848937|"~     This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM~     citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3~     mM acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate~     the performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq,~     compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.~   "
15928|NCT02848924|"~     Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in~     cases of severe bleeding. In all cases the functional is a major issue with a potential~     reach of walking ability and maintaining the seated and standing positions. The treatment of~     such lesions requires management to a specialist, or the ability to use such centers for~     advice or transferring patients. This organization was recommended after the symposium of~     the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the~     incidence and clinical features of these fractures have evolved to worsening the functional~     prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study~     assessing needs and practices at national and regional level. The long-term objective is to~     propose a regional organization of care of these patients in order to reduce morbidity and~     mortality associated.~   "
15929|NCT02848911|"~     The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with~     acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of~     increasing doses and different infusion times of AFM11 infusion in patients with adult~     B-precursor ALL~   "
15932|NCT02848872|"~     The hypothesis of this study is that functional tumor infiltrating lymphocyte (TIL)~     isolation from resected lung cancer specimens is feasible, allowing determination of tumor~     antigen-specific T cell reactivities. The primary objective of this study is to investigate~     the feasibility of isolating functional tumor infiltrating lymphocytes s(TILs) to determine~     tumor antigen-specific T cell re-activities in 30 resected lung tumor specimens. Successful~     isolation of TILs will be defined as collecting 1x10-6 viable, CD45+ mononuclear cells or~     greater from tumors containing >/=1 gram of excess tissue. If successful isolation of TILs~     can be obtained from >/= 66% of resected tumor specimens, the protocol will be considered~     feasible. The primary exploratory objective is to identify immunologic signatures that~     predict clinical outcomes from cytotoxic chemotherapy and/or immunotherapy.~   "
15933|NCT02848859|"~     This is a pilot study randomizing patients with insomnia and coronary heart disease to~     either general sleep hygiene counseling and web-based cognitive behavioral therapy for~     insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral~     therapy at a later date).~   "
15934|NCT02848846|"~     The NEBIAS (NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS)~     proposal aims at developing and clinically evaluating (in selected amputees) a~     neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the~     natural one. This will be possible by means of a novel neural interface able to provide a~     stable and very selective connection with the nervous system. This goal will be achieved by~     combining microtechnology and material science and will allow, on one side, recording of the~     motor-related signals governing the actions of the amputated hand/arm for the motion control~     of a mechanical prosthesis, and on the other providing sensory feedback from tactile and~     kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within~     the residual limb. The NEBIAS proposal is also aimed at finding out the 'language'~     intrinsically linking central nervous system with peripheral nerve signals in order to~     govern simple and complex hand/fingers movements. To reach this goal, a variety of~     techniques exploring brain and nerve functions will be assembled and integrated; this~     includes the analysis of electromagnetic brain and nerve signals, as well as of~     movement-related changes in brain's blood flow/metabolism.~   "
15935|NCT02848833|"~     To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type~     2 diabetes mellitus in a routine clinical practice setting~   "
15936|NCT02848820|"~     OBJECTIVE~      The aim of this study is to compare the effectiveness of initial non-operative treatment~     strategy (reserving appendectomy for those not responding or with recurrent disease) with~     immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple~     appendicitis in terms of complications, health-related QOL and costs.~      Main research question: What is the difference in proportion of patients experiencing~     complications within 1 year between both strategies in children from 7 to 17 years old,~     inclusive, with acute simple appendicitis?~   "
15937|NCT02848729|"~     This study is to test the hypothesis that an opioid used to treat postsurgical pain, IV~     morphine, will impact the absorption of coadministered oral acetaminophen and result in~     altered pharmacokinetics in healthy subjects.~   "
15938|NCT02848716|"~     This is an international, prospective, multicenter and randomized phase III study designed~     to determine if patients with locally advanced cervical cancer have longer overall survivals~     with pretherapeutic paraaortic surgical staging when compared to radiologic staging.~   "
15939|NCT02848703|"~     Myocardial perfusion is a major parameter characterizing the status of capillary circulation~     of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI)~     during the 1st pass of a contrast agent through the capillary system. This technique is~     radiation-free, but it is difficult to repeat measurements during a single exam. Also, a~     number of patients suffering from cardiac disease cannot receive contrast agent injections.~     The investigators have developed a totally non-invasive approach for quantifying myocardial~     perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the~     capillaries (Arterial spin labeling, ASL).~      Goal : The major goal of this research protocol is to validate a totally non-invasive method~     of myocardial blood flow quantification using MRI without contrast agent injection~   "
15940|NCT02848690|"~     This parallel, randomized clinical trial will include 120 participants. They will be~     allocated to a sodium restriction educational intervention or usual care groups. The~     educational intervention will be planned based on the DSRQ application and sessions will be~     conducted once a month for the period of six months. Both spot urine collection to estimate~     sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the~     end of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM)~     will be conducted at the beginning and at the end of the follow-up. Anthropometric~     measurements, blood pressure measurement and 24-hour food recall will be collected during~     follow-up.~   "
15941|NCT02848677|"~     Cardiovascular disease (CVD) is considered the main cause of mortality in the western world.~     There are many factors that contribute to the onset and progression of cardiovascular~     disease, including hypertension. Hypertension is a multi-factorial condition that includes~     nutritional disorders in its causality line. It is believed that advanced glycation~     end-products (AGEs) is one of the pathophysiological causes that explain the occurrence of~     high blood pressure in diabetic patients. This study has the role of describing the protocol~     of a randomized clinical trial aiming to evaluate changes in serum levels of end products of~     advanced glycation after an intervention for eating habit changes in hypertensive~     individuals.~      The investigators designed a randomized clinical trial, with non-blinded assessment of~     outcomes. Participants will be recruited from the outpatient clinic for hypertension of a~     public hospital in Porto Alegre, aged from 40 to 80 years old and without diabetes.~     Hypertension is defined as systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90~     mmHg, or antihypertensive medication use. Participants will be assigned to one of two~     groups. The intervention group will receive monthly educational intervention sessions for~     low salt diet, high in fruits and vegetables, and low in processed foods for a period of 6~     months. Besides these, the intervention group will receive a standard telephone interview~     every two weeks to motivate them to follow the diet. The control group will receive the~     usual counseling for low sodium diet in monthly appointment with a dietitian, following the~     hypertension care clinic protocol.~      This study aims to investigate if there are significant changes in serum levels of advanced~     glycation end products, after the nutritional intervention with diet guidance in fruits,~     vegetables, low in sodium and processed foods in hypertensive patients because several~     studies have shown that less processed food rich in antioxidants with low sodium content,~     play an important role in reducing levels of AGEs which are precursors of vascular~     inflammation and progression of cardiovascular diseases.~   "
15964|NCT02848378|"~     This study investigates the levels of advanced oxidation protein product and monocyte~     chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25~     participants with chronic periodontitis, 25 participants with gingivitis and 25~     periodontally healthy subjects are included into this study. In each participant, four sites~     are identified for gingival crevicular fluid samples.~   "
15942|NCT02848664|"~     The purpose of this study is to develop appropriate training methods and gather participant~     feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST~     is a small device that provides external vibratory stimulation to the larynx during~     swallowing and swallowing training. A secondary purpose of the study is to determine how 3~     months of use of the PMSST affects swallowing physiology, brain activation, oral intake and~     quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on~     use of the vibratory device.~   "
15943|NCT02848651|"~     This is a Phase II, open-label, prospective, multicenter study designed to evaluate the~     efficacy and safety of single-agent atezolizumab in participants with treatment-naive~     locally advanced or metastatic NSCLC. In addition, the primary biomarker objective is to~     evaluate various predictive cutoffs for novel blood-based diagnostic assays.~   "
15944|NCT02848638|"~     The primary goal of the study is to see if the PET/CT will be able to determine the precise~     location of the Y-90 particles within the liver and within the tumors. We hope to use this~     information in order to see if these particles distribute evenly throughout large tumors or~     if the particles go into the tumor which is located in the portal vein.~      The secondary goals are threefold. First correlate the distribution of Y90 particles (as~     demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a~     difference in the Y90 particle's distribution when a low particle load (1-3 million~     particles) is used compared to when a high particle load (6-8 million particles) is used.~     Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently~     being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair~     production PET research imaging.~   "
15945|NCT02848625|"~     This study will evaluate whether regular yoga exercises designed specifically for patients~     with Idiopathic Pulmonary Fibrosis is associated with any change in quality of life. Half of~     the participants will be randomized to yoga, half to usual care. After the first group~     completes 12 weeks of yoga, the patients who were randomized to usual care will completed 12~     weeks of yoga.~   "
15946|NCT02848612|"~     To prevent thromboembolic complications, the embolization procedure is performed under~     prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care~     testing according to international guidelines. However, these guidelines are based on~     limited scientific evidence and the ideal level of anticoagulation required has not been~     precisely defined. Furthermore, the correlation between the point-of- care tests used at~     Amiens University Hospital and the reference methods used in the laboratory varies~     considerably according to the available literature.~   "
15947|NCT02848599|"~     The purpose of this study is to determine whether epidural levobupivacaine applied for the~     purpose of post-operative analgesia compared to systemic analgesia with morphine leads to~     better pain control, stronger suppression of the inflammatory response and the production of~     inflammatory mediators, faster recovery of patients and consequently less incidence of~     postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of~     femoral fractures.~   "
15948|NCT02848586|"~     The purpose of this study is to determine if using e-cigarettes (ECIG) rather than regular~     tobacco cigarettes alters lung inflammation in people with HIV. The study is also interested~     in asking subjects their opinion on the use of ECIG and how they make them feel. This study~     is for research purposes only and is not intended to treat asthma or HIV or to modify~     tobacco use.~   "
15949|NCT02848573|"~     we propose this study and try to find out possible clinical applicable non-invasive imaging~     indices or its combination with the laboratory indices to predict the status of hepatic~     fibrosis in BA patients.~   "
15950|NCT02848560|"~     This is an observational study for children with Cystic Fibrosis (CF) who are eligible based~     on their CF gene type. One group will be called the treatment group because they have the~     gene type (homozygous F508del) that makes them clinically eligible through their CF care~     provider to begin treatment with the new FDA approved CF drug called orkambi. For the~     control group, children will be enrolled who have a similar CF gene type (heterozygous~     F508del) but are not eligible to be prescribed orkambi.~      The two groups will be followed for four visits over about 3 to 4 years to observe changes~     in the lungs. Methods to measure the changes in lung disease will include:~      MRI with non-FDA approved inhaled xenon gas to take detailed images of the lungs, Pulmonary~     Function Tests (PFT), Lung Clearance Index (LCI), Baseline CT image of the lungs if not~     ordered as part of usual clinical care.~      The first two visits will be done before starting clinical treatment with orkambi and will~     be a minimum of 28 days apart and up to 18 months. The third visit will be scheduled about 3~     months after starting orkambi and the fourth visit about 18 months later. For the control~     group, the timing of visits will be similar to treatment group and visits may be scheduled~     around annual CF care visits.~   "
15951|NCT02848547|"~     An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this~     study we estimate the incidence of type 2 diabetes among participants enrolled in the~     diabetes prevention programme. This will provide comparison of the progression to diabetes~     among group motivated through text messages and the group educated only during enrollment. A~     total of 537 participants were enrolled in the primary study and are invited to participate~     in a follow-up visit 3 years post active trial period.~   "
15965|NCT02848365|"~     Postoperative sore throat (POST) is a common problem following the use of endotracheal~     intubation during general anaesthesia. It leads to dissatisfaction and discomfort after~     surgery and can delay a patient's return to normal routine activities. POST has been rated~     by patients as the eighth most adverse effect in the postoperative period. The incidence of~     sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal~     intubation also leads to hemodynamic stress response. The response can be deleterious in~     patient with or without cardiac disease. It is related to the degree of manipulation of the~     airway during endotracheal intubation and has been studied during intubation for some~     equipment used for endotracheal intubation~   "
15966|NCT02848352|"~     The study aimed at identifying whether different expectations have an impact on experiencing~     emotions in the form of sadness.~   "
15997|NCT02847949|"~     This is a Phase 2 multi-center, open-label study that allows subjects who derived clinical~     benefit after completing IGN002 treatment in a separate Valor study (e.g. IGN002-101) to~     continue treatment with IGN002. Subjects who completed a separate Valor-sponsored IGN002~     study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are~     eligible to participate in this study.~   "
15952|NCT02848534|"~     The gold standard for diagnosing a bacterial infection is isolation of the pathogenic~     germ, which is not easy in routine clinical practice.~      Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on~     admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP)~     and procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other~     causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the~     specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%)~     and the specificity was 81% (95% CI: 67%-90%).~      The first cellular immune response to infection consists of the mobilization of polynuclear~     neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory~     cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection~     site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN)~     observed in bacterial infections.~      Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be~     used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis~     in the emergency department was studied and the researchers found higher diagnostic values~     than for CRP and PCT.~      The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or~     hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied~     before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the~     white blood cell count and the PNN).~   "
15953|NCT02848521|"~     This is a prospective, non-interventional study (NIS) measuring health-related quality of~     life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD~     patients in Europe.~   "
15954|NCT02848508|"~     To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to~     adapt a fixed metformin daily posology according to renal function on the basis of the first~     short-term study made by the investigators.~   "
15955|NCT02848495|"~     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of~     the general population. The devastating complication of IA is its rupture, resulting in~     subarachnoid haemorrhage that can lead to severe disability and death.~      Unfortunately, there are neither reliable clues nor diagnostic tools to predict the~     formation and/or the fate of an IA in a given individual. Also, there is no pharmacological~     drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage.~     Current treatments are invasive with a significant risk of procedural morbidity. Thus, still~     now, the management of patients with IA remains extremely challenging and still~     controversial.~      Although the pathogenesis of IA has been the subject of many studies for the last decade,~     the mechanisms underlying IA formation, growth and rupture are still mostly unknown and~     relevant animal models of IA are not available.~      Familial history of IA predisposes to IA formation and rupture and increasing evidence~     suggest a genetic component of IA formation, with heterogeneous modes of inheritance and~     penetrance.~      This project, gathering neuroradiologists, geneticists and vascular biologists, addresses~     the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and~     predictive tools of risk of IA.~      The investigators propose to identify IA-causing variants by whole-exome sequencing in~     familial forms of the disease.~      The investigators hypothesises that the functional analysis of the causal / susceptibility~     variants thus identified will provide clues to understanding the pathological mechanisms of~     IA formation, and the bases for developing diagnostic tools. This project aims at meeting~     this challenge. Based on preliminary data that already allowed to identify such a variant,~     and the combination of genetic and functional investigations, the specific objectives of~     this project are: - To identify IA-causing variants in familial forms of the disease by~     whole-exome sequencing; - To understand the function of these genes/ variants in the~     formation and rupture of IA by molecular and cellular approaches and generation of relevant~     animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.~   "
15956|NCT02848482|"~     Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or~     photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated~     by exposure to light of a specific wavelength in the presence of oxygen. In recent years,~     PDT has been introduced as an important novel disinfection therapy in the field of implant~     dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial~     PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment~     of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and~     is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.~      Inconsistent results have been reported regarding the potential role of PDT as an adjunct to~     mechanical debridement in the management of peri-implant infection. Thus, the aim of the~     present trial is to investigate the treatment effect of non-surgical treatment with and~     without photodynamic therapy on initial peri-implantitis.~   "
15957|NCT02848469|"~     The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3~     fatty acids in the reduction of risk of psychosis.~      The study is being coordinated by the HRB Clinical Research Facility at University College~     Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy~     University Hospital, Cork. The study will be carried out in collaboration with the HRB~     Clinical Research Facility in Dublin in prior to rolling out to other centres around~     Ireland.~      The Study is funded by Stanley Medical Research Institute, a non-profit organization~     supporting research on the causes of, and treatments for, schizophrenia and bipolar~     disorder. It is the largest provider of funding for research in serious mental illness~     outside of the U.S. government.~   "
15958|NCT02848456|"~     This study investigated the effects of spinal manipulation on central nervous system~     activity. The presence of postactivation potentiation, an increase in muscular force~     production following prior muscular contractions, was measured with electromyography and the~     muscular force production during electrically-induced calf muscle reflexes. It was~     hypothesized that significantly greater potentiation would be stimulated by a calf muscle~     contraction with spinal manipulation delivered immediately beforehand than the potentiation~     arising from the contraction only.~   "
15959|NCT02848443|"~     The main purpose of this study is to assess the safety and tolerability and to determine the~     recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with~     metastatic colorectal cancer.~   "
15960|NCT02848430|"~     Human safety studies will be carried out to test whether hop botanical dietary supplements~     used by peri- and post-menopausal women are safe to use with Food and Drug Administration~     (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at~     the University of Illinois at Chicago without any harmful effects) will be given with four~     selected FDA-approved drugs to determine if the hop supplement can increase or decrease how~     these medications are absorbed, metabolized and excreted by the human body. Preclinical~     studies predict that the hop supplement might affect the metabolism or break down of these~     probe drugs.~   "
15998|NCT02847936|"~     Surgical repair of perineal lesions after delivery can be associated with infection of the~     surgery site. The aim of this study was to compare the surgical site infection with~     triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after~     delivery.~   "
15967|NCT02848339|"~     Data about aspirin desensitization for patients with coronary artery disease undergoing~     percutaneous coronary intervention are sparse.~      This is a prospective, multicenter, observational study including 7 italian centers, to~     assess safety and feasibility of a standard desensitization protocol in patients with~     aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin~     sensitivity undergoing coronary angiography are prospectively enrolled.All patients~     underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20,~     40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5~     hours.All patients are followed for desensitization procedure success, description of~     reactions due to the desensitization procedure, and in hospital major adverse cardiac events~     (MACE). All patients are also followed-up for 12 months in order to assess their long-term~     risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA~     sensitivity.~   "
15968|NCT02848326|"~     This study will evaluate the safety and tolerability of the following doses of AGN-241689:~     10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the~     prevention of episodic migraine and will characterize the dose/response relationship.~   "
15969|NCT02848313|"~     This is an open-label, Phase 1 single-center study in approximately 40 subjects who have 1~     eye with intermediate AMD, including a high-risk drusen without geographic atrophy (GA)~     subgroup and a noncentral GA subgroup. Eligible subjects will receive 40 mg of elamipretide~     administered as a once daily 1.0 mL subcutaneous injection for 12 weeks.~   "
15970|NCT02848300|"~     This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost~     Formulation A and Formulation B following 14 days of once daily topical administration in~     male participants with androgenetic alopecia (AGA).~   "
15971|NCT02848287|"~     Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA~     are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are~     several preventive strategies but none of them completely prevent EA.~      Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might~     reduce the incidence of postoperative EA.~   "
15972|NCT02848274|"~     The purpose of the study is to develop a prognostic index model for the rare disease of~     mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical~     data at various institutions. The investigators hope this will enable the identification of~     low- and high-risk groups for survival in order to improve patient care and outcome.~   "
15973|NCT02848261|"~     The primary objective of this project is to examine the impact of a continuous glucose~     monitoring (CGM) intervention on health and psychological outcomes in young children with~     type 1 diabetes (T1D).~   "
15974|NCT02848248|"~     The study will examine the safety profile of SGN-CD123A. The study will test increasing~     doses of SGN-CD123A given every 3 weeks to patients.~   "
15975|NCT02848235|"~     Kenya recently adopted new treatment guidelines for pregnant women with HIV, which calls for~     all women to initiate triple-drug antiretroviral therapy (ART) at or soon after their first~     visit for antenatal care. As part of this new standard of care to prevent mother to child~     transmission of HIV (PMTCT), Kenya also established the Kenya Mentor Mother Program (KMMP)~     in 2012 to provide guidance for standardizing peer education and psychosocial support~     services within the national PMTCT program. This new standard of care (life-long ART and the~     KMMP) will only yield significant improvements in preventing mother to child transmission if~     women accept the triple-drug treatment during pregnancy and adhere to visit schedules so~     that they receive uninterrupted supplies of their medications during pregnancy through at~     least the cessation of breastfeeding. The primary objectives of this study are: (1) to~     evaluate implementation of the new guidelines in Kenya under actual, real-world conditions~     in major maternal and child health clinics in the southern Rift Valley region of Kenya; and~     (2) to evaluate, also under routine program conditions, the benefits of an innovative~     intervention package designed to improve implementation of the new treatment guidelines. The~     intervention uses the existing Mentor Mothers, who already are part of the PMTCT program~     staff at clinics. At the end of each clinic visit, the Mentor Mother will review with~     patients their treatment plan and schedule their next visit. The Mentor Mother will also~     offer, at each encounter, to send a text message reminder to the patient for their next~     clinic visit and offer to set up an automatic reminder directly on the patient's cell phone.~     The intervention strategy was developed in close collaboration with local health facility~     and PMTCT program staff based on their prior and on-going experience providing PMTCT~     services in the region, and this strategy has the potential to dramatically improve PMTCT~     service delivery and support global goals to eliminate mother to child transmission.~      The study is taking place in 12 clinics in the south-rift valley region of Kenya. A total of~     360 patients will be enrolled into the study (approximately 30 at each clinic). The~     investigators are enrolling patients to receive their permission to look at information~     recorded in their medical records. All patients eligible for the study, who provide written~     consent, will be included in the study until the target number of 360 is obtained. After~     consenting, the study will have no further contact with patients. Because the study only~     reviews information in medical files that clinics already collect as part of routine care,~     risks to patients are minimal. The only possible risk is the accidental disclosure of HIV~     status, but the study is designed to minimize such a risk. There are no direct benefits to~     study participants, as the study is designed to understand existing adherence to PMTCT care~     and treatment and to improve such adherence. The study is expected to start in 2016 and end~     in 2019.~   "
15976|NCT02848222|"~     The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist~     Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be~     done by assessing for improvement in ocular oil gland function and comfortable contact lens~     wearing time after one month of daily warm compress application. The efficacy of the Bruder~     Moist Heat Compress applied once will be compared to twice daily application as well as~     compared to warm compress application using a wash cloth.~   "
15977|NCT02848209|"~     The purpose of this study is to examine the histological skin changes induced by different~     peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous~     undermined facial skin flaps.~   "
15978|NCT02848196|"~     The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT~     technique in oligometastatic patients affected by adrenal gland metastases.~   "
15979|NCT02848183|"~     The purpose of this study is to optimize therapy according to the known risk factors and~     treatment response in pediatric acute myeloid leukemia (AML)~   "
15980|NCT02848170|"~     Phase 3 study to examine the relation between antihypertensive effect and baseline factors~     exploratively, compared to olmesartan medoxomil in patients with essential hypertension.~   "
15996|NCT02847962|"~     Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid,~     although sorghum and cowpea may be suitable alternative FBF commodities. The objective of~     the Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to~     determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or~     better, nutritive value and acceptance compared to a traditional corn-soy blend. The~     effectiveness of each blend will be determined in an efficacy study of Tanzanian children~     under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.~   "
15981|NCT02848157|"~     Caudal block is often performed to relieve postoperative pain in pediatric urological~     surgery. Recently, pudendal block is also used in penile surgery and it has advantage~     because of less side effects such as transient weakness of low extremities, but limited to~     use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic~     drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an~     alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect~     and potentiates the effect of local anesthetics. There are many studies about the~     potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it~     has been limited in pediatrics. Recent study said that local anesthetics with~     dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal~     block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine~     in pediatrics as well as adults.~   "
15982|NCT02848144|"~     Infectious shocks are associated with high mortality rates (20-40%). Anti-inflammatory~     strategies based on the postulate that mortality related to sepsis is mainly due to an~     overwhelming pro-inflammatory immune response have failed. Some patients surviving this~     initial phase can develop immune dysfunctions because the compensatory mechanisms become~     deleterious when they persist over time. The persistence of immunosuppression at day 3 or 5~     is independently associated with more nosocomial infections and higher mortality rate. The~     clinical and laboratory evidence for sepsis induced immunosuppression have been recently~     reviewed by Hotchkiss et al. Apoptosis-induced depletion of immune effector and blood~     studies from septic patients showed decreased production of pro-inflammatory cytokines,~     decreased HLA-DR expression, increased percentage of regulatory T cells, and increased~     production of programmed cell death (PD)-1. Some small positive phase 2 trials of biomarker~     guided immune enhancing agents granulocyte-macrophage colony stimulating factor (GM-CSF) and~     interferon γ (IFN γ) have been reported.~      There are insufficient data showing that such an immunosuppression exists in children. Only~     one study performed in children with organ dysfunctions admitted to pediatric intensive care~     unit (PICU), showed that 34% of them developed immunosuppression. This study was performed~     on a heterogeneous population and immunological analyses were limited. Therefore, there is a~     crucial need of studies on septic patients with matched controls to provide more evidence~     that the same paradigm exists in children. The collaboration of laboratories with a high~     level of experience in this domain, and a clinical unit with a high potential of recruitment~     of children with severe infectious shock should allow us to perform the first prospective~     study specifically done in children with infectious shock.~      The main hypothesis is that children with severe infectious shock developed sepsis-induced~     immunosuppression as shown in adults. This will be assessed by the expression of HLA-DR on~     monocytes' surface. We make the hypothesis that children who become immunosuppressed are~     more prone to develop secondary nosocomial infectious and stayed longer in PICU and in~     hospital.~      Children aged from 1 month to 17 years, admitted to PICU at HFME Lyon-Bron are eligible if~     they have the criteria for severe sepsis or septic shock, defined by the Surviving Sepsis~     Campaign 2012 or those of Toxic Shock Syndrome (TSS) (definitions of CDC - Center for~     Disease Control). An information leaflet will be issued to parents and children /~     adolescents and they will be informed of their right to object to the search. Are provided~     as part of this research:~        -  Immunological measures (mHLA -DR) in three stages: in the first 48 hours, between D3/5~          and D7/9. The volume of collected blood will not exceed 2.4 ml / kg.~        -  The collection of nosocomial infections and status at D30 A control group of patients~          hospitalized for surgery without sepsis or toxic shock criteria will be recruited in~          the same hospital by ICU investigators and matched for age. Similarly controls will be~          given oral and written information and they will have the opportunity to deny~          inclusion. They will have the same exams as the first group of patients.~   "
15983|NCT02848131|"~     The study goal is to assess the effect of senescent cell clearance on senescence burden,~     physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC)~     functionality in patients with chronic kidney disease (CKD).~   "
15984|NCT02848118|"~     Procedure sedation of flexible bronchoscopy (FB) comforts patients undergoing FB.~     Hypoventilation during FB is a concern. The investigators investigate the feasibility of~     monitoring capnography in FB sedation.~   "
15985|NCT02848105|"~     aGVHD remains as complication in patients after allogeneic stem cell transplantation.~     Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab~     study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit~     CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects.~     In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment~     may improve the outcome of aGVHD.~   "
15986|NCT02848092|"~     Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative~     driving outcomes, including motor vehicle crashes, which may be caused by visual inattention~     (i.e., looking away from the roadway to perform secondary tasks). A driving intervention~     that trains teens to reduce instances of looking away from the roadway will be tested in~     teens with ADHD.~   "
15987|NCT02848079|"~     This study will examine the safety and effectiveness of oxaliplatin in combination with~     TAS-102 (TAS-OX) for treatment of patients with metastatic colorectal cancer whose cancer~     has progressed or recurred after FOLFOX chemotherapy.~   "
15988|NCT02848066|"~     The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor~     biomarker with gastric cancer pts and cancer-free healthy volunteers.~   "
15989|NCT02848053|"~     Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a~     long-term effect on the risk of diabetes and provide evidence that early intervention by~     traditional Chinese medicine could delay the progression from impaired glucose tolerance to~     diabetes.~      Study contents: 1.420 participants were followed up for 8 years to assess the long-term~     effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of~     impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To~     participants that determined the status of glucose metabolism, a variety of ways were used~     to find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory~     sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin~     injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral~     glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed~     to assess the state of glucose metabolism. 4. Questionnaires were given to all the~     participants to investigate their condition of treatment, diet, exercise and other~     lifestyle.~   "
15990|NCT02848040|"~     Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the~     UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients~     with inflammatory bowel disease.~      The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for~     BAM, but it is not widely available and it is also time consuming, expensive and involves~     exposure to radioactivity. Some clinicians give a course of blind or empirical treatment~     instead. The National Institute of Clinical Excellence (NICE) recognised these issues and~     highlighted the need for cheaper and safer tests to identify BAM.~      This study will assess the accuracy of a simple, convenient and inexpensive laboratory test~     for the rapid diagnosis of BAM which measures bile acids in stool. This test has the~     potential to have a broad impact on clinical practice and patient care by enabling doctors~     to identify and treat patients with BAM promptly. Results from the second phase of the study~     will allow the assessment of the benefits of monitoring the stool test to determine whether~     the bile acid changes can predict the response to treatment and dosage needed for each~     patient.~   "
15991|NCT02848027|"~     Single-center, lab blinded to include up to 200 subjects with knee osteoarthritis.~     Collection of synovial fluid from diseased knee before and after Regenexx®SD treatment will~     serve as the experimental condition, i.e. the osteoarthritic knee.~   "
15992|NCT02848014|"~     The purpose of the study is to determine whether a short psychological intervention aiming~     at optimizing expectations is able to foster positive emotions and whether an intervention~     inducing positive emotions is able improve participants' expectations. Furthermore, the~     investigators will examine whether both interventions are effective in buffering the stress~     response after an acute stressor in a healthy sample compared to a control condition.~   "
15993|NCT02848001|"~     CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects~     with relapsed or refractory acute myeloid leukemia~   "
15994|NCT02847988|"~     The primary aim of this proposal is to test the effectiveness of neuromuscular electrical~     stimulation (NMES) in improving functional status and muscle function in patients receiving~     prolonged mechanical ventilation.~   "
15995|NCT02847975|"~     Investigators recently showed that tadalafil restores functional sympatholysis in patients~     with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD~     via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also~     be restored by sodium nitrite— which is an indirect nitric oxide donor.~   "
15999|NCT02847923|"~     The aim of this study is evaluate a software developed for alternative communication~     designed for people with speech difficulties. The software was executed by 30 volunteers~     using mobile devices that helped to play the scenarios simulated of communication~     situations.~   "
16002|NCT02847884|"~     Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any~     part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness,~     stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss,~     skin rashes, arthritis and inflammation of the eye.~      Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children.~     In adults it has been shown that the amount of this drug a person has in their blood can~     show how well it is working for them. Health Canada has approved Infliximab -IFX for the~     treatment of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to~     younger children when other therapies do not resolve their disease symptoms. This is called~     off-label use of Infliximab.~      IFX levels in the body and consequently its efficacy can be influenced by many biological~     characteristics within the patient's body. In about 17% of those treated with IFX, the~     patient's immune response against IFX may lead to a three to fivefold increased risk of loss~     of response. This immune response to the medication often occurs when drug levels are~     undetectable in the body. Thus it is in order to achieve best results with this treatment,~     physicians need to be able to adjust dosing specific to each patient. A recent study has~     shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up~     to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next~     infusion.~      In order to minimize the loss of response, we hope to conduct an observational cohort study~     of pediatric patients treated with IFX.~      This open label, cohort study aims to:~        1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect~          IFX levels during the first three loading infusions~        2. Obtain data to create a model that can guide and adjust the IFX dose and frequency to~          achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.~   "
16003|NCT02847871|"~     Loss of mobility is predictive of a loss of autonomy and is often the first sign of~     functional decline. Loss of mobility is also associated with poor perceived quality of life,~     depressive symptoms, high risk of adverse events such as falls and fractures, to an~     increased risk to input in institution and mortality's increase.~      Consequences and frequency of loss of mobility make essential its identification, evaluation~     and the practice of preventive measures in primary care.~      The implementation of effective interventions in primary care to prevent or delay the loss~     of mobility is a public health priority.~      PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care,~     based on a personalized multimodal intervention: screening, support combining physician,~     teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and~     nutritional counseling.~   "
16004|NCT02847858|"~     Health -E-You is an interactive, individually tailored computer application (App) that was~     developed to educate adolescent girls about contraceptive methods and assist them in~     selecting a contraceptive method that meets their individual needs. The goal is to reduce~     disparities in unintended pregnancy rates among Hispanic adolescent females.~      The App was designed in close collaboration with clinicians and Hispanic adolescents.~     Health-E You was designed to be used in conjunction with a clinical encounter to prime both~     the patient and provider prior to the face-to-face visit to facilitate the discussion and~     provision of appropriate contraception. It is founded on key principles of Social Cognitive~     Theory.~      Through an interactive approach, Health-E-You assesses the users' sexual health risks,~     knowledge and contraceptive use history and preferences to facilitate a sense of agency and~     self-efficacy around selecting an effective contraceptive method. First, the user selects~     their preferred language (English or Spanish) and according to the selected language, the~     App provides a brief description of the module and consents the user to participate. It then~     assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers~     to the truth vs. myth statements are then presented to the user as short, easy-to-read~     explanations. Next, the App assesses the user's individual contraceptive needs and~     preferences. The user is also screened for possible medical contraindications to~     contraceptive methods. Based on the user's input, the App provides individually tailored~     messaging and recommendations for contraceptive methods according to the user's own timeline~     for childbearing and their lifestyle preferences, past experiences and needs. The~     recommendations are presented on a visual continuum of effective contraceptive options based~     on desired duration of action and efficacy. Users then have the option to learn more about~     the recommended method(s) and they also have the option to learn more about any of the~     contraceptive options. Evidence-based contraceptive information is presented in a~     user-friendly format that includes YouTube style videos. Users can select to view brief~     video vignettes that feature clinicians who provide additional information about the method~     of interest and/or videos of diverse young women who discuss their experiences with each of~     the contraceptive methods. At the end of the App, adolescents are asked to select the method~     (s) they are most interested in using. They are also encouraged to use condoms to protect~     against sexually transmitted infections (STIs) and provided information about emergency~     contraception. Users can review a summary of a key information gathered from the App and are~     offered the opportunity to share that information with their clinician so that the clinician~     can better support the adolescent in selecting and using an effective and appropriate~     contraceptive method.~      The objective of this study is to evaluate the effectiveness of Health-E You on its ability~     to address disparities in contraceptive knowledge, access and utilization among Hispanic~     adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse~     (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based~     Health Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be~     randomized, with equal chance, to use the Health-E You App or to provide usual care (without~     the App). A total of 1400 Hispanic adolescents will be selected to participate in the study~     (700 at intervention clinics and 700 at the control clinics). The investigators hypothesize~     that adolescents who use the Health-E You App will have greater sexual health knowledge and~     will be more likely to use effective contraceptive than adolescent who do not use the App.~     The investigators will also evaluate the effectiveness of the App on its ability to improve~     the effectiveness and efficiency of the health visit. Participants will be asked to complete~     follow-up surveys immediately following the clinical encounter and at three and six months~     after the clinical encounter.~      The ultimate goal of this study is address health disparities in the use of effective~     contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among~     at-risk Hispanic adolescent girls.~   "
16005|NCT02847845|"~     The purpose of this study is to verify the efficacy of taking red ginseng for chronic~     fatigue patient.~   "
16006|NCT02847832|"~     The ability of different methods to discriminate between benign and malignant adnexal masses~     has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA~     logistic regression model LR2 were superior to RMI and to all other methods for predicting~     malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of~     methods requires them to be applied on the same tumor population.~      The general objective of this study is to prospectively validate the Simple Rules, ADNEX,~     the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct~     comparison of these tools.~      IOTA7 is an international multicenter prospective observational study including different~     types of ultrasound centers and examiners with different levels of ultrasound experience. In~     total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.~   "
16007|NCT02847819|"~     Total of 100 patients are included in this is a prospective observational study to evaluate~     the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing~     thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be~     compared to post operative ultrasound scans.~   "
16008|NCT02847806|"~     Sexual steroids administered to supra-physiological doses are likely to change the~     carbohydrate and lipid metabolism.~      Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic~     treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both~     steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by~     the reference method of the hyperinsulinemic euglycemic clamp.~   "
16009|NCT02847793|"~     Cognitive biases are a hallmark of depression but there is scarce research on whether these~     biases can be directly modified by using specific cognitive training techniques.~      The aim of this study will be targeting and modifying specifically relevant attention biases~     in participants with subclinical depression using eye-tracking methodologies. This~     innovative approach has been proposed as a promising future line of intervention in~     Attention Bias Modification procedures (Koster & Hoorelbeke, 2015).~      Recent findings suggest that depression is characterized by a double attentional bias (Duque~     & Vazquez, 2015), More specifically, depressed individuals have difficulties both to~     disengage from negative materials (e.g., sad faces) and to engage with positive materials~     (e.g., happy faces). Thus, training procedures to change attentional biases should target~     these two separate components.~   "
16010|NCT02847780|"~     This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel~     techniques (causing least discomfort to the patients) for the detection of impaired~     vocal-cord movement after thyroid surgery.~   "
16011|NCT02847767|"~     The high dose per fraction (>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy~     (SABR) has been shown to be more effective at local tumor control than treatments employing~     more conventional dose fractions. The mechanisms for this are currently under debate. One~     possible mechanism for this increased effectiveness is that high dose/fraction causes~     significant vascular damage to the tumor. This study hopes to measure vascular integrity pre~     and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.~   "
16012|NCT02847754|"~     Standard indications for palliative radiation of bony metastases include pain, spinal cord~     compression, and impending pathologic fractures.~      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid~     complications. Tailored training of the paravertebral musculature may support Radiation~     therapy and improve above named factors. DISPO-2 was designed to investigate the impact of~     tailored physical exercise in patients with unstable vertebral metastases as compared to~     manual therapy (massage etc.). The trial includes patients with painful unstable bony~     metastases, patients with spinal cord compression or impending pathological fractures are~     excluded. The investigations are carried out in a prospective randomized controlled phase-II~     parallel group design.~   "
16037|NCT02847390|"~     The investigators will develop a novel diabetes prescriber superuser educational program~     focused on inpatient diabetes management for physicians, based on their input. The~     investigators will then examine the impact of the diabetes prescriber superuser program and~     an analogous diabetes nurse superuser program that is already developed on glycemic control~     and other outcomes in hospitalized patients with diabetes.~   "
16013|NCT02847741|"~     Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to~     the understanding of SB is a stress vulnerability model, but so far, all scientific works~     has no clinical application. The management of psychiatric patients, including depressed~     subjects, faces the inability to detect those with a high risk of SB. Many studies have~     shown a link between low cholesterol and SB. A study has recently proposed a total~     cholesterol threshold below which the risk of suicide could be increased. However, a~     prospective study is needed to assess the predictive nature of such an indicator.~   "
16014|NCT02847728|"~     This is an observational, multicenter study in patients treated with nivolumab for the~     approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the~     United States (US). Targeted countries in the EU for study participation include Austria,~     Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to~     assess the safety experience, survival, adverse event management, and outcomes of adverse~     events associated with nivolumab in routine oncology care facilities.~   "
16015|NCT02847715|"~     Improvements in cancer treatment have led to an increasing number of patients being cured or~     in remission, but they are followed up to detect recurrence, manage persistent symptoms and~     late treatment effects. With growing survivors, traditional hospital follow-up is not~     sustainable. New models of follow-up care are needed. This research project aims to develop~     and establish the feasibility of introducing a new electronic care pathway/system for remote~     monitoring ovarian cancer patients in remission. The project includes a development phase,~     followed by a before-and-after study to explore the feasibility of a new pathway/system for~     remote monitoring.~   "
16016|NCT02847663|"~     This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after~     a muscle damage protocol.~   "
16017|NCT02847650|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     PF-06649751 in Parkinson's disease patients at early stage of the disease.~   "
16018|NCT02847637|"~     This is a randomized, multicenter, open-label, Phase 3 clinical study in participants aged~     12 years or older to evaluate the efficacy, safety, and pharmacokinetics of prophylactic~     emicizumab versus no prophylaxis in participants with severe hemophilia A without inhibitors~     against FVIII.~   "
16019|NCT02847624|"~     The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in~     patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world~     clinical setting in Japan.~   "
16020|NCT02847611|"~     The main objective of this work is to validate the dynamometer LABIN in comparison with the~     technique of gold-standard reference JAMAR, in a healthy population.~      The infringement of the prehension is frequent and impacts on the social and professional~     quality of life of the patients. There are numerous instruments measuring the strength of~     prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the~     maximal strength of the prehension. It is at present Gold Standard for the measure of the~     strength of prehension. There is for the moment no electronic known instrument exploring the~     endurance of the strength of prehension during an effort of tightening. This parameter would~     indeed be interesting for the exploration in geriatrics and in the neuromuscular~     pathologies.~      This study justifies itself by the fact that the dynamometer LABIN should allow the~     evaluation of the muscular endurance of the strength of hand as complement of the peak of~     strength~   "
16021|NCT02847598|"~     The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing skin~     disease activity in participants with systemic lupus erythematosus (SLE) (Part A), and in~     participants with active cutaneous lupus erythematosus (CLE) with or without systemic~     manifestations (Part B), and to investigate the dose response relationship in participants~     with active SLE and skin manifestations (Part A only). Secondary objective is to evaluate~     additional efficacy parameters of BIIB059 in reducing SLE disease activity.~   "
16022|NCT02847585|"~     Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children.~     Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10~     (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has~     shown significant health benefits in adult patients with cardiovascular disease, it is worth~     studying water-soluble coenzyme Q10 supplements to evaluate their potential role as~     complementary therapy for PDCM. The purpose of this study is to explore the potential role~     of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will~     recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between~     coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection~     fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant~     enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and~     inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months~     water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will~     assess the quality of life of PDCM patients by questionnaire. Through this study, we expect~     to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and~     will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac~     function and reduce inflammation, and further reduce the rate of heart transplantation and~     increase quality of life in PDCM.~   "
16023|NCT02847572|"~     This will be a single center, non comparison clinical trial. Fifty study patients will have~     the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their~     non-dominant eye. The investigators will be evaluated vision at distance, intermediate and~     near as well as assessing patient satisfaction and spectacle independence.~   "
16055|NCT02847156|"~     Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data~     mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in~     young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF~     children are rare and the impact of most frequent viruses such as human rhinoviruses is~     usually not correctly evaluated.~      The aim of this study is to assess the frequency of lower and upper RVI during a 1 year~     follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and~     therapeutic level.~      Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the~     short term and without any particular link with a specific virus as previously described.~   "
16024|NCT02847559|"~     The purpose of this research study is to determine the effects bevacizumab (the study drug)~     combined with Optune (the study device) tumor treatment field therapy has on meningiomas.~     Bevacizumab is considered investigational because the US Food and Drug Administration (FDA)~     has not approved its use for the treatment of meningiomas. The study drug is a medication~     that blocks the growth of new blood vessels. It is thought that the study drug may interfere~     with the growth of new blood vessels and therefore might stop tumor growth, and possibly~     shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood~     vessels. Optune is also considered investigational because the US FDA has not approved its~     use for the treatment of meningiomas. Optune is a device that the patient will wear and use~     for at least 18 hours of each day. It delivers alternating electrical current to the~     patient's brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to~     occur in order for cell division to occur and allows tumors to grow. By slowing this~     process, we hypothesize that meningioma growth may also be slowed.~   "
16025|NCT02847546|"~     The primary objective of this study is to collect data to confirm the performance and safety~     of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in~     the preparation for Transcatheter Aortic Valve Implantation (TAVI).~   "
16026|NCT02847533|"~     This study focuses on blood inflammatory markers (pro-inflammatory cytokines,~     anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant~     unipolar depression in comparison with non-resistant unipolar depressed patients.~   "
16027|NCT02847520|"~     If the addiction to games of chance and gambling is a disease of increasing knowledge, the~     emergence of poker rout evaluation procedures, prevention and treatment usually offered to~     players in need. In the case of poker, which unlike other games has a real part to address~     and which damages are expressed differently, the evaluation can not be done identically to~     other games. This problem has often been emphasized in the literature, in particular the~     lack of specific tools for the identification of poker gambling problems. Thus, the fact of~     developing a specific evaluation tool could allow poker to take into account the specificity~     of poker among other games. This would be part of the evaluation complement batteries~     currently available to players in general by offering a specific tool, and secondly to allow~     the assessment of the aspects of the problems often absent for other games . The goal here~     is to develop and validate a specific tool detection of problem gambling in the particular~     context of poker.~   "
16028|NCT02847507|"~     Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France~     in 2016.~   "
16029|NCT02847494|"~     This is an emergency department based randomized trial in which we compare two different~     treatment for migraine headache. The goal is to decrease the number of headache days during~     the week after ED discharge.~   "
16030|NCT02847481|"~     This is a randomized pilot study to characterize engraftment of a donor's microflora onto~     patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota~     transplantation.~   "
16031|NCT02847468|"~     Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with~     inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has~     both antiangiogenic and antiproliferative effect, is the only therapeutic with proven~     survival benefits. However, the efficacy of Sorafenib remains inconstant with a media~     overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the~     overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to~     find an early and accurate way to determine which patients are best responding to therapy in~     order to avoid the toxicity and cost of ineffective therapy.~      Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited~     performance in the setting of HCC because of lack of sensitivity, in particular for~     well-differentiated tumours. However FDG uptake is related to proliferation rate and is an~     efficient marker survival following liver transplantation and selective internal radiation~     therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static~     scan provides better characterization of the tumour by adding information on tumour~     perfusion.~      FCH which reflects lipids metabolism and specifically choline kinase activity, has shown~     promising results for detection of HCC when compared with FDG alone. Moreover, choline~     activity is related to a kinase pathway in mammalian cells, which is specifically inhibited~     by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour~     differentiation, by opposition to FDG. Therefore, several studies have suggested that~     combined evaluation of tumour glucose and lipid metabolism could play a complementary role~     for the evaluation of HCC in the setting of detection, staging and to predict recurrence~     following surgical resection. Thus, the investigator hypothesize that the combination of FDG~     and FCH may be the most accurate imaging evaluation of HCC.~      Thus the aim of the present study is to determine the predictive performance of survival of~     lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with~     advanced HCC.~   "
16032|NCT02847455|"~     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a~     randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into~     three groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of~     ilaprazole, 5, 10 mg/day, and one of Rabeprazole 10 mg/day as positive control. The primary~     endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its~     resolution from active to scarring stage. Symptoms relief was evaluated as secondary end~     points by using a graded score. Safety and tolerability were evaluated on basis of clinical~     assessments.~   "
16033|NCT02847442|"~     The purpose of this study is to evaluate the change in subject's condition according to the~     Investigator's Global Assessment of Change after three months of treatment with 50 mg~     opicapone once daily in a heterogeneous patient population reflecting daily clinical~     practice.~   "
16034|NCT02847429|"~     This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral~     crenolanib versus oral placebo in combination with best supportive care in subjects with~     advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120~     subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching~     placebo orally (PO) 3 times daily (TID) in combination with best supportive care.~   "
16035|NCT02847416|"~     the aim of this study are to explore the characteristics of mean airway pressure,~     oscillatory amplitude and power spectral density (PSD) of oscillatory airway pressure that~     generate by various loaded and flow rate during expiration and inspiration in healthy~     subjects and to explore the best loaded and flow rate for airway secretion clearance using~     the BreatheMAX® device~   "
16036|NCT02847403|"~     The overall objective of the study is to assess the potential effects of the long-acting~     GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and~     related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).~   "
16056|NCT02847143|"~     The study aims to characterize the cerebral activation modifications related to nasal~     oxytocin administration during vizualisation of distress images in population of healthy~     people with different attachement styles.~   "
16038|NCT02847377|"~     The development of biomarkers will lead the dynamic of personalized medicine and fill the~     unsatisfied needs in oncology for prediction of therapeutic response.~      Molecular imaging enables non invasive quantification of biomarkers. The development of~     molecular imaging biomarkers is closely related to the development of therapeutic molecules.~     Among the potential targets, kinases offer a lot of advantages: (i) they play a central role~     in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in~     biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic~     (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic~     indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the~     most sensitive and dedicated to evaluate small molecules. However few radiotracers are~     available and their specificity limits their clinical use. The IMAkinib® approach is an~     innovative method proposed to develop new PET radiotracers adapted to current medical and~     economical challenges.~      The epidermal growth factor receptor (EGFR) is an established target for the treatment of~     advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)~     Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved~     for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).~     Unfortunately the majority of patients will develop a resistance to the TKI in the long term~     (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients~     (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool~     to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators~     have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated~     ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine~     the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a~     compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET~     imaging.~   "
16039|NCT02847364|"~     The purpose of this study is to determine whether chewing gum post-operatively decreases the~     time to first flatus or defecation in patients undergoing spine surgery as a indirect~     indicator of post-operative ileus.~   "
16040|NCT02847351|"~     The study aimed to investigate whether an Arabinoxylan-enriched crackers consumption for 4~     weeks in overweight and obese patients without diabetes mellitus have specific healthy~     effects on glycemic control (reduction of homeostatic model assessment -HOMA index-).~     Furthermore, study evaluated the effects of Arabinoxylan on insulin, lipid and Ghrelin.~   "
16041|NCT02847338|"~     High blood pressure (Hypertension) is extremely common and is a major cause of heart~     disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will~     require treatment for hypertension at some point in their lives. A healthy lifestyle alone~     is often not enough to control blood pressure, and drug treatment is usually required.~     Although a wide variety of drugs are available to treat hypertension, choosing the right~     kind of tablet or combination of tablets for individual patients is a problem, and therefore~     many people have poor blood pressure control.~      Hypertension treatment within the UK is currently selected according to age and self-defined~     ethnicity (SDE). There are limitations to this approach which include wide variability in~     the response to hypertension drug classes between people. There is also uncertainty about~     selecting hypertension drugs for ethnic minorities other than those of African/Caribbean~     ancestry, for example, South Asians because of a lack of information from trials. In the AIM~     HY-INFORM study the investigators are looking to recruit equal number of black/caribbean,~     south asian and white european participants to be able to compare differences in~     hypertension treatments and ethnicity.~      The primary objective of this study is to determine if the response to antihypertensive~     drugs differs by self defined ethnicity.~   "
16042|NCT02847325|"~     AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits~     Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in~     inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte~     activation (predominantly B-cell activation) in the preclinical studies. The nonclinical~     program has demonstrated that AC0058TA has the potential to interfere with signaling~     functions mediated by tyrosine kinases and may be useful for controlling excessive or~     aberrant T- and B-cell activation in autoimmune diseases.~      As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the~     unmet need of this patient population, for whom there are currently no effected therapies~     and there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves~     the disease process.~   "
16043|NCT02847312|"~     In this proposed human trial, the investigators aim to establish whether 4 weeks of daily~     consumption of beta-glucan matched meals providing either a high dose or a moderate dose of~     oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in~     markers of CVD risk and gut health relative to an energy matched control intervention in~     healthy adults with above average blood pressure.~   "
16044|NCT02847299|"~     The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance~     techniques requiring no equipment other than the volumetric fan. The two methods are~     air-stacking and hyperinflation .~      The study is a Cross-over, monocentric and open label study~   "
16045|NCT02847286|"~     A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004,~     containing 25 MG of Dapivirine.~   "
16046|NCT02847273|"~     Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures~     regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a~     normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at~     the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new~     4-wavelength generation of NIRS monitors which could reliably assess real-time absolute~     values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2~     values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the~     new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.~   "
16047|NCT02847260|"~     The purpose of the study is to evaluate the safety and tolerability of a rapid dose~     titration regimen of subcutaneous Remodulin® therapy in patients with PAH.~   "
16057|NCT02847130|"~     This research study seeks to identify, understand, and overcome barriers to the use of~     clinical practice guidelines by pediatric oncology healthcare providers The treatments for~     childhood cancers are intense and result in a high rate of symptoms which require support by~     healthcare providers. By reviewing patients' medical chart records, meeting in focus groups~     and in one-on-one interviews, healthcare providers may improve how clinical practice~     guidelines are used to support children undergoing cancer treatment.~   "
16058|NCT02847117|"~     Mastiha is a natural product from the tree Pistacia lentiscus var. Chia (Anacardiaceae)~     growing exclusively in the Southern part of Chios Island. It is the natural resinous exudate~     produced after longitudinal incisions made at close intervals from the base of the trunk up~     to the thicker branches of the tree. U.S. Food and Drug Administration has classified~     Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as~     anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European~     Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to~     the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders,~     skin inflammation and healing (EMA/HMPC/46758/2015).~      However, the bioavailability of its microconstituents in human biological samples is still~     undetermined. To this end, the current study aims to investigate the whether Mastiha's~     compounds are bioavailable in healthy adults. Twenty apparently healthy men, aged 20-40~     years old, will be enrolled based on certain inclusion and exclusion criteria. The staff of~     the study will provide detailed information regarding the aims, the methods, anticipated~     benefits and potential hazards of the study and all patients will receive the Patient~     Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether~     they want to participate in the protocol. Each patient agreeing to participate will sign an~     Informed Consent document and the staff will explain to patients that they are under no~     obligation to enter the trial and that they can withdraw at any time during the trial,~     without having to give a reason. A copy of the signed Informed Consent will be given to the~     participant.~      After enrollment, the volunteers will undergo a medical and dietary assessment and their~     health status will be evaluated through a complete blood count. Then, they will follow a~     low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables,~     legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and~     after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood~     samples will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha~     intake. Until timepoint 6h, they will be allowed to consume only water. Urine samples will~     also be collected on timepoints 0h, 4h, 8h and 24h.~      After collection, the phenolic and terpenoid content or metabolites of Mastiha will be~     identified in plasma samples applying LC-HRMS. Additionally, the metabolomic profile will be~     assessed in plasma samples with LC-HRMS and in urine samples with NMR-based metabolomics.~     Oxidative stress will be evaluated through the CuSO4 technique and oxidised LDL levels in~     serum samples, as well as F-2 isoprostanes in urine samples.~   "
16365|NCT02843113|"~     Through Stepping Up 4 Your Child, non-custodial fathers will be provided with a~     comprehensive, solution-oriented program featuring group based parent education and~     individualized case management to help them achieve financial independence, increase their~     parenting skills, and develop a co-parenting alliance.~   "
16048|NCT02847247|"~     Purpose: The purpose of this study is to classify volunteers as endotoxin-responders or~     non-responders following inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE).~     Endotoxin is a commonly encountered bioaerosol and component of indoor and outdoor air~     pollution. For reasons that remain unclear, some individuals appear to be more susceptible~     to the inflammatory effects of inhaled endotoxin than are others, possibly owing to single~     nucleotide polymorphisms in the Toll-like receptor 4 (TLR4) gene that influence TLR4~     signaling and function. These susceptible individuals represent a population of particular~     interest for further mechanistic studies of the effects of endotoxin and for therapeutic~     trials. Susceptibility to inhaled endotoxin will be determined by measuring change in~     peripheral blood neutrophil counts, a biomarker of systemic inflammation, following inhaled~     CCRE. In our previous work, the investigators have found that inhalation of 20,000 EU CCRE~     is well tolerated and induces measurable increase in neutrophil content of peripheral blood~     in susceptible individuals. Our hope is that this CCRE inhalation protocol can be employed~     to screen large populations for susceptibility to the inflammatory effect of inhaled~     endotoxin.~   "
16049|NCT02847234|"~     Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or~     dental infections. The infection can rapidly descend into the mediastinum and lead to a~     life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive~     care with radiologist and with early and repeated surgical debridement. Anti-inflammatory~     drugs have been incriminated by authors in the development of necrotizing fasciitis.~     Recently, a single-center study demonstrated that pharyngeal source of CNF and oral~     glucocorticoid intake before admission was associated with the occurrence of mediastinitis.~      The aim of the study is to assess the incidence and factors associated with CNF~     complications, in particular mediastinitis. Secondary outcome is to describe patient~     characteristics, medical and surgical management.~      Methods: A retrospective, observational, non-interventional multicentre study is conducted~     in nine intensive care units in France from January 2005 to December 2016.~   "
16050|NCT02847221|"~     Successful weaning from mechanical ventilation in ICU patients depends on patient ability to~     breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow~     (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a~     dedicated flow-meter that required patient disconnection from the ventilator, limiting the~     generalizability of this procedure. This study aimed to predict extubation outcome in a~     consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF~     measurements were done by freezing ventilator screen and scrolling the cursor to the maximal~     value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.~      The objective was to assess the performance of CPF to predict early extubation outcome.~   "
16051|NCT02847208|"~     Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis~     (CF). Only few studies have described contraceptive practices in cohorts of CF women.~      The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon~     adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire~     about their contraceptive choices, frequency of gynaecological follow-up and cervical~     screening. Other clinical data were collected from the CF adult centre registry.~      One hundred and twenty women (100%) answered the questionnaire, among whom two were~     post-menopausal (46 and 59 years of age), and five were pregnant.~      Seventy-four per cent of the women declared they had undergone gynaecological followup (89%~     of the women with transplantation), and only 55% reported having at least one previous Pap~     smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite~     immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic~     women, it was 61%. Among contraception users; 65% used oral contraception, predominantly~     combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only~     contraception. Intrauterine device accounted for 10% of patients using contraception, and~     tubal ligation only 4%.~      This study is limited by its cross-sectional design. Despite an internal validation of the~     questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken~     into account.~      This study of practices highlights the importance of improved information regarding~     sexuality, fertility and reproductive health in young women with CF. A regular~     gynaecological follow-up and cervical screening is mandatory in this population.~      Better gynaecological care and contraceptive advice would help to avoid unplanned~     pregnancies, and optimize contraceptive selection in relationship to specific clinical~     conditions.~   "
16052|NCT02847195|"~     Assess the depth of sedation and analgesia in pediatric intensive care is critical to the~     management of intubated patients under mechanical ventilation. The responsiveness of the~     pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in~     anesthesia and intensive care to assess the quality of analgesia in adult population.~     Visually measuring the diameter of the pupil remains very imprecise, but this measure can be~     accurately and quickly performed thanks to portable devices called Pupillometers. Some~     devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter,~     the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed~     of contraction. Pupillometry was tested in adult ICU patients, during painful and painless~     procedures [1]. In this study, pupillometry was more sensitive for detecting pain compared~     to the change in heart rate or bispectral index. The objective of this work is to perform~     measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU.~     In parallel we will continue using the Comfort B-scale (has been validated for assessment of~     pain in children admitted to a pediatric intensive care unit [2-5] and compare the results~     of both types of assessment pain.~   "
16053|NCT02847182|"~     This is a single site, prospective, randomized, double-blind study of a single intravenous~     autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with~     Autism Spectrum Disorder (ASD). Participants will be randomly assigned to Sequence A,~     consisting of a single infusion of CB cells at baseline followed 6 months later by a single~     infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline~     followed 6 months later by an infusion of CB cells. All participants will ultimately be~     treated with CB cells at some point during the study. Participants with an available~     qualified autologous CB unit will receive autologous cells, and those without a suitable~     autologous CB unit available will receive cells from a ≥4/6 HLA-matched, ABO-matched~     allogeneic, unrelated donor CB unit from the Carolinas Cord Blood Bank. All infusions will~     be double-blinded. The primary outcomes will be assessed 6 months after the initial infusion~     in the sequence. Additional testing for secondary exploratory analyses will be performed at~     12 months. Duration of study participation will be 12 months from the time of baseline~     infusion.~   "
16054|NCT02847169|"~     The aim of this prospective study is to evaluate the clinical performance of filcon IV1~     toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.~   "
16059|NCT02847104|"~     Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously~     known diabetes. It was demonstrated that hyperglycemia was associated with increased~     hospital mortality in various medical and surgical ICU situations. However, discrepant~     results from recent randomized, clinical trials of tight blood glucose control in ICUs have~     not allowed conclusions regarding whether there is a causal link between hyperglycemia and~     ICU mortality. In addition to the mean blood glucose level, glucose variability has recently~     been emphasized as an independent predictor of ICU and hospital mortality. This concept has~     been described in a wide variety of medical, surgical and trauma ICU patients. In all of~     these settings, glycemic variability was measured with various indices but was steadily~     associated with ICU and/or hospital mortality in non-diabetic ICU patients. Conversely,~     glycemic variability was either weakly or not associated with mortality in ICU patients with~     previously known diabetes. Notably, all of these data have been observational, and~     interventional trials remain lacking to assess the impact of glycemic variability reduction~     on ICU mortality and thus to demonstrate causality. However, glycemic variability was~     considered sufficiently important to be mentioned in recent international guidelines for the~     management of hyperglycemia in critically ill patients. In these publications, experts from~     the American College of Critical Care Medicine emphasized that glycemia should be maintained~     at less than 9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic~     variability. To achieve these goals, computer-based insulin infusion protocols have~     demonstrated their superiority to paper-based protocols. Glucose concentrations, variation~     per unit of time between the last and current glucose measurements, insulin dosage, and~     carbohydrate intake were the main input variables used in these different computerized~     algorithms. However, such protocols are not widely available because commercial systems have~     licensing fees and academic protocols do not always go beyond the pilot phase.~      To address this issue, the investigators adapted a previously validated, paper-based,~     dynamic protocol (DP) to an actual recommended glycemic target range. Our aim was to assess~     the efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol,~     compared to a paper-based, sliding scale static protocol (SP).~   "
16060|NCT02847091|"~     The objective of this study is to assess the reduction in insulin dose from baseline at Week~     24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when~     ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes~     mellitus receiving insulin therapy.~   "
16061|NCT02847078|"~     The purpose of the study is to investigate the effects of smart phone app on the secondary~     prevention for patients with coronary heart disease post percutaneous coronary intervention.~   "
16062|NCT02847065|"~     In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes.~     E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia.~     In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public~     health, causing increased mortality, particularly in the elderly, and an increase in the~     average hospital stay. However, few studies have specifically concerned with the criteria~     associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally,~     improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E.~     coli has importance in terms of public health and is a prerequisite to the development of~     preventive strategies and to improve the short-term prognosis.~   "
16063|NCT02847052|"~     IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial~     barrier function and regeneration during experimental colitis. IL-22 binding protein is a~     small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing~     the binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding~     protein is regulated in Inflammatory bowel disease to better understand the way IL-22 acts~     on epithelial cells during flares of the disease.~   "
16064|NCT02847039|"~     The research project aims to try to answer the many questions raised by the identification~     of new early repolarization syndrome. The questions are varied with both taking optimal~     clinical management of patients, the frequency and significance of this anomaly in the~     population on the electrophysiological and molecular basis responsible for this~     electrocardiographic abnormality.~      To try to answer these many questions, the approach will be twofold: clinical and genetic.~        -  Establishment of a clinical database containing information of patients who have been~          identified as carriers of the anomaly based on the initial clinical presentation in~          order to determine their prognoses.~        -  Physiological approach will be based on a molecular approach to identify genetic~          abnormalities may be involved in this syndrome.~        -  200 asymptomatic patients and an unlimited number of patients who presented syncope or~          aborted sudden death will be included.~      A blood sample (15 ml) will be performed at inclusion.~   "
16065|NCT02847026|"~     This is an open-label phase IV, randomized controlled trial of inactivated poliovirus~     vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster~     dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying~     IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and~     fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus~     vaccines will be evaluated.~   "
16066|NCT02847013|"~     This present investigation aims to determine whether a transversus abdominous plane(TAP)~     block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section~     decreases post-operative pain. The hypothesis is that performance of the TAP block with~     liposomal bupivacaine will decrease post-operative narcotic use.~   "
16067|NCT02847000|"~     Patients with pancreatic cancer which has stopped responding to one or more chemotherapy~     drugs are asked to take part in this study. The study hopes to find out whether decitabine,~     the drug being studied, will have an effect on pancreatic cancer. The decitabine is being~     given at a lower dose than its approved use. It is also being given with another drug,~     tetrahydrouridine (THU), to improve the exposure of your pancreatic cancer cells to~     decitabine.~      The purpose of this study is to determine if the drug combination of decitabine and~     tetrahydrouridine can recognize a certain DNA target in your cancer. All cells have DNA~     within them, and tumor cells have abnormal DNA.~   "
16068|NCT02846987|"~     The purpose of this study is to test any good and bad effects of the study drug called~     Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects.~     Researchers hope to learn if the study drug will delay the growth of the cancer or shrink~     the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA~     approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with~     breast cancer, lymphoma, and lung cancer.~   "
16097|NCT02846610|"~     The German Network for acute pain management and Regional Anesthesia (NRA) is a~     multi-center, non-interventional registry and benchmark project, assessing and analysing~     clinical and patient-reported procedural and outcome data of systemic analgesia and regional~     anesthesia hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and~     professional Society German Anesthetists (BDA)~   "
17036|NCT02834351|"~     The purpose of this study is to evaluate the effect of muscle ischemia during claudication~     on mitochondrial function.~      Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac~     group) feasibility study.~   "
16069|NCT02846974|"~     Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency~     patients, providing a continuous estimate of hemoglobin saturation in arterial blood.~     Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller~     centres and poor countries, putting millions of patients in danger of easily treatable and~     preventable conditions. With current rapid prototyping technologies such as 3D printing, it~     is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold~     standard. The goal of this study is to develop, validate and certify a pulse oximeter that~     measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be~     certified with Health Canada, and then released under the Open Hardware License (OHL), such~     that hospitals and ministries of health in rural and impoverished communities in Canada and~     internationally would have easy access to these devices.~   "
16070|NCT02846961|"~     The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar~     CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately~     to severe inflammatory bowel disease.~   "
16071|NCT02846948|"~     The aim of the study is to identify the diagnostic value of the focused assessed~     echocardiography protocol (FATE - Holm et al 2012) for patients undergoing urgent abdominal~     surgery and having signs of sepsis. The extended cardiac monitoring may affect patient's~     management during perioperative period. The investigators expect that the incidence of~     hemodynamic instability will be reduced and the outcomes of the patients will be improved.~   "
16072|NCT02846935|"~     The purpose of this study is to evaluate how well the study drug works and safety of oral~     decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is~     being given at a lower dose than used for its approved use. It is also being given with~     another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to~     decitabine.~   "
16073|NCT02846922|"~     To evaluate the efficacy of catheter ablation and rate control in heart failure patients~     with atrial fibrillation.~   "
16074|NCT02846909|"~     Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be~     lost in the second trimester, which is much lower than in the first trimester. Once a~     pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.~      Congenital fetal abnormalities and maternal anatomic factors as immunologic factors,~     infection, and thrombophilia should be considered; however, a reason and its result~     connection may be difficult to be established.~      Cervical incompetence means that the cervix is weak and unable to remain closed during the~     pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in~     maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to~     ascending infection may be more important.~      Cervical cerclage is performed usually in women with a history of mid-trimester abortion or~     spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing~     recurrent loss.~      Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians~     despite the absence of a well-defined population for whom there is clear evidence of~     benefit. Furthermore, there is little consensus on the optimal cerclage technique and timing~     and type of suture placement.~      The Progesterone is known to have an inhibitory action on uterine contractility and is~     thought to play a main role in the maintenance of pregnancy until term. Progesterone is also~     able to modify the ultrastructural organisation of the myometrium by inhibiting the gap~     junctions, and preventing muscular contraction.~      Different routes of administration of progesterone have been described in the literature.~     These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and~     daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.~      A recently published Cochrane review further confirmed the beneficial effects of~     progesterone in infant health following administration in women considered to be at~     increased risk of preterm birth due either to past history of preterm birth or when a short~     cervix was identified on ultrasound.~      However; most of these published studies have been conducted to test the effect of~     progestational agents for the prevention of preterm labor not miscarriage.~      Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler~     ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth~     retardation and fetal anemia, and it plays an important role in managing of these conditions~   "
16075|NCT02846896|"~     PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental~     pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking.~     Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of~     diseases. In addition, the investigators study will be the first one carried out in the~     country on PBC, and therefore will raise disease awareness and create a network.~   "
16076|NCT02846883|"~     This project is to determine the safety and explore the effectiveness of allogeneic (not~     cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in~     decreasing inflammation and possible enlargement of the participants' abdominal aortic~     aneurysm. Participants will be selected as a possible subject because of an abdominal aortic~     aneurysm discovered on the ultrasound or computed tomographic (CT) scan requested by the~     participants' doctor.~      The purpose of this study is to collect information that will be used to determine if MSCs~     can be used to decrease inflammation and possibly slow down enlargement of the participants'~     aneurysm. The investigators will also be collecting blood samples to study special~     inflammatory cells that cause aneurysms as well as asking participants to have a PET~     (positron emission tomography) scan that can measure inflammation directly in the~     participants' aneurysm.~   "
16077|NCT02846870|"~     This randomized clinical trial studies how well visually enhanced education works in~     improving prostate cancer and treatment knowledge in patients with prostate cancer that has~     not spread to other places in the body. Visually enhanced education includes pictures,~     drawings, and photos, may help doctors better convey information about radiation and~     prostate cancer to patients.~   "
16078|NCT02846857|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy~     regulates glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective of this study is to compare, in a randomized multicenter trial, the~     effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented~     pump therapy with low-glucose suspend in regulating day-and-night glucose levels in~     outpatient settings for 15 weeks in adolescents and adults.~      The investigators hypothesize that dual-hormone closed-loop will reduce time spent in~     hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective~     than sensor-augmented pump therapy with low-glucose suspend.~   "
16079|NCT02846844|"~     In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3)~     Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and~     Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform~     Training (Experimental).~   "
23386|NCT02751060|"~     The purpose of this study is to determine whether the expression level of miR-320a are~     effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of~     coronary heart disease.~   "
16080|NCT02846831|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy~     regulates glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective of this study is to compare the effectiveness of single-hormone closed-loop,~     dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in~     regulating day-and-night glucose levels in adults with T1D for 2 weeks in outpatient~     settings.~      The investigators hypothesize that dual-hormone closed-loop will increase the percentage of~     time of glucose levels spent in the target range in adults compared to single-hormone~     closed-loop, which in turn will be more effective than sensor-augmented pump therapy.~   "
16081|NCT02846818|"~     Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB)~     during cardiac surgery. The aim of the present study is to investigate whether the lactate~     to pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow~     reflects a derangement of global cerebral energy state during cardiopulmonary bypass.~   "
16082|NCT02846805|"~     The purpose of this study is to investigate to what extent IOs improve the functionality of~     edentulous patients and changes in quality of life and overall patient satisfaction~     following treatment with IOs.~   "
16083|NCT02846792|"~     This phase I/II trial studies the side effects and best dose of plinabulin when given~     together with nivolumab and to see how well they work in treating patients with stage~     IIIB-IV non-small cell lung cancer that has come back or spread to other places in the body.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving nivolumab and plinabulin together may work better~     at treating patients with non-small cell lung cancer.~   "
16084|NCT02846779|"~     The purpose of this study is to evaluate three pharmacist-outreach strategies for improving~     adherence to insulin among individuals with diabetes. The three approaches are~     equivalently-priced but vary by degree of targeting and intervention intensity.~   "
16085|NCT02846766|"~     This is a two center, open label, non-randomized Phase II study of lenvatinib in adult~     subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR~     signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day~     cycles.~   "
16086|NCT02846753|"~     A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for~     the treatment of pulmonary regurgitation with or without stenosis in patient with native~     outflow tracts.~   "
16087|NCT02846740|"~     This pilot study aims to investigate whether a treatment called cranial electric stimulation~     or CES can decrease risk factors for suicide. The specific CES device we will use is called~     Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).~   "
16088|NCT02846727|"~     The purpose of this study is to determine if fluorescence angiography can detect occult~     shock (hypoperfusion).~   "
16089|NCT02846714|"~     The overall purpose of this study is to test the feasibility, acceptability, and preliminary~     efficacy of a family-focused behavioral intervention (FLARE, which stands for Family~     Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive~     behaviors among children at elevated risk for the disease.~   "
16090|NCT02846701|"~     The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie~     before the daily taking dose of duloxetine) in patients relieved of at least 30% of their~     neuropathic pain with duloxetine treatment.~      The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6~     hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic~     pain with duloxetine treatment.~      Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the~     degree of pain relief and to evaluate the sensation of the global improvement experienced by~     the patient.~   "
16091|NCT02846688|"~     To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal~     Mucosa.~   "
16092|NCT02846675|"~     it's a self-control, double blind study of autologous adipose-derived stromal vascular~     fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under~     IRB-approved protocol in a feasibility and safety study.~   "
16093|NCT02846662|"~     Background: Depression is a usual comorbid event associated to chronic diseases, such as~     hypertension and diabetes, constituting an important public health problem, with negative~     consequences for patients' quality of life and self-care, as well as for compliance with~     medical treatment. In low and middle income countries depression is often unrecognized and~     untreated, and there is a lack of human resources to treat depression and other mental~     problems in these health care systems.~      Aim: The present study aims to test a 6 week low-intensity psychological intervention~     (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms~     and co-morbid diabetes and/or hypertension recruited in primary health care units, in São~     Paulo (Brazil).~   "
16094|NCT02846649|"~     The objective is to determine feasibility and acceptability of a text message (SMS)-based~     relapse prevention intervention as measured through: (1) study retention and SMS query~     completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease~     of use. Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment~     for opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS)~     score of >3 and are being discharged to outpatient (community) resources. All participants~     receive standard of care in the ED, complete a baseline web survey, are asked to text with~     us for at least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone~     call between day 8 and 14. Investigators expect preliminary findings to support a relapse~     prevention intervention delivered through SMS. Based on feedback from this mixed methods~     study, investigators plan to test a refined SMS program in a randomized trial.~   "
16095|NCT02846636|"~     The main objective of this study is to evaluate the 10 year performances of Mpact cup in~     total hip arthroplasty.~   "
16096|NCT02846623|"~     The goal of this clinical research study is to learn if atezolizumab and obinutuzumab~     (either with or without ibrutinib) can help control CLL. The safety of this drug combination~     will also be studied.~   "
16098|NCT02846597|"~     The appropriate pressure and duration needed for sustained lung inflation in preterm infants~     at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating~     two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds,~     during the application of sustained lung inflation in the resuscitation of preterm infants~     with respiratory distress in the delivery room.~   "
16099|NCT02846584|"~     The main purpose of this study is to explore the sequential therapeutic effect and evaluate~     the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of~     relapse/refractory B cell malignancies.~   "
16100|NCT02846571|"~     The treatment in this trial consists of intraocular islet transplantation. A single dose of~     1000 - 2000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the~     anterior chamber of the eye through a self-sealing incision of the peripheral cornea. The~     procedure is projected to take approximately 20-30 minutes. Subject will remain flat on~     their back for 45-60 minutes after islet infusion to maximize adhesion of the islets to the~     iris.~   "
16101|NCT02846558|"~     This is a pragmatic, single-blinded randomized trial of improving adherence to dietary~     interventions in patients with MS who are receiving monthly natalizumab infusions.~   "
16102|NCT02846545|"~     The primary purpose of this study is to determine if golimumab can preserve beta-cell~     function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).~   "
16103|NCT02846532|"~     The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic~     (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy~     administered to pediatric participants 2 to 8 years of age with single ventricle physiology~     who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to~     evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched~     to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid~     (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for~     thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle~     physiology who have completed the Fontan procedure within 4 months prior to enrollment.~   "
16104|NCT02846519|"~     The purpose of this study is to evaluate the pharmacokinetics of intranasally administered~     esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to~     evaluate the effects of rifampin on the pharmacokinetics of intranasally administered~     esketamine in healthy Caucasian participants.~   "
16105|NCT02846506|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     co-administered with canagliflozin in healthy fed and fasted participants.~   "
16106|NCT02846493|"~     This prospective, randomized, controlled clinical trial will evaluate the effect and~     security of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.~   "
16107|NCT02846480|"~     To find out the effectiveness of physical therapy associated with the surgical treatment~     over the simptoms and quality of life in III and IV grades of pelvic organ prolapse,~     patients will be randomly assigned to one of these groups: experimental group: pre-surgical~     and post-surgical physical therapy + behavioral education + surgical therapy. Control group:~     surgical treatment + behavioral education.~      In both groups several physical therapy assessments will be undertaken: 1st before surgery;~     2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months~     post-surgery.~   "
16108|NCT02846467|"~     The aim of this study is to evaluate the comprehension of the Informed consent with the~     Standard Verbal Communication (SVC) versus Portable Video Media (PVM).~   "
16109|NCT02846454|"~     This proposed randomized, double blinded 12 week crossover human feeding study aims to~     investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety~     by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes~     in the human gut microbiota in healthy weight males (22 to 24.9kg/m2)~   "
16110|NCT02846441|"~     Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons.~     When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain~     post-hepatectomy liver function, techniques as preoperative portal vein embolization or~     two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be~     performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ~     liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on~     the basis of standardized future liver remnant or future liver remnant on body weight.~     However, decrease of liver function between stages, measured by means of laboratory~     parameters, has been demonstrated to be associated with higher 90-day mortality, regardless~     of FLR volume. In other words, this volumetric increase may not reflect the increase of~     liver function.~   "
16111|NCT02846428|"~     This study will evaluate the efficacy and safety of treatment with oral capecitabine or~     intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide,~     prior to surgery in participants with breast cancer. The participants will receive 4 cycles~     of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin +~     Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85).~     After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast~     surgery with regional lymph node dissection will be performed, followed within a maximum of~     6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both~     study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square~     (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second~     treatment period, participants will enter the post-treatment follow-up period which will~     last for 5 years from the initial date of participant randomization. During this period~     participants will be evaluated once a year on the anniversary date of randomization.~   "
16138|NCT02846077|"~     The project is designed to document in college undergraduates the relationships among~     sleep/wake timing and duration, use of mobile phones and other electronic devices, food~     timing and content, self-reported mood and physiological measures.~   "
16245|NCT02844686|"~     New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary~     results suggested that dynamic acquisitions could allow the assessment of myocardial flow~     reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the~     feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac~     SPECT in 20 patients.~   "
16112|NCT02846415|"~     This study intends to use Play Intervention for Dementia (PID) to promote cognitive~     functions of people with early to moderate dementia.~      This is a cluster randomized controlled trial aims to recruit 38 participants from two study~     sites. Participants will be randomly allocated into intervention or wait-list controlled~     groups. Both groups will receive the same content of PID programme at different time. The~     PID consists of 12 weekly sessions. Each session lasts for 45-75 minutes. The PID will be~     facilitated by a play specialist, trained elderly volunteers, and centre staffs. Cognitive~     functions will be evaluated with Montreal Cognitive Assessment, Fuld Object Memory~     Evaluation and Modified Verbal Fluency Test, conducted by a trained research assistant~     blinded to group allocation. Centre staffs (not involved in the PID) will be interviewed.~     Every alternate session will be video-taped for understanding the experience of the~     participants in the PID programme.~   "
16113|NCT02846402|"~     HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are~     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers~     in Kampala, Uganda. This study will determine whether directly giving participants an HIV~     self-test or giving them a coupon to collect a test at a drug store or clinic improves~     outcomes compared to standard of care.~   "
16114|NCT02846389|"~     Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The~     investigators think that moderate exercise, done 15 minutes at a time, can reduce the~     fatigue. This study is designed to gather more information, so that in the future, doctors~     can recommend whether patients should engage in exercise during a radiation treatment~     course.~   "
16115|NCT02846376|"~     The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or~     the combination of nivolumab with ipilimumab given after bone marrow transplant for patients~     with acute myelogenous leukemia and myelodysplastic syndrome.~   "
16116|NCT02846363|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,~     France (AVC69) the investigators observed that only a small percentage of patients could~     access to thrombolysis in time. In this cohort of 1306 patients treated in one of the~     emergency department of the Rhone region for a suspected stroke, 84% of patients reached~     hospital through an emergency department instead of going directly to a stroke unit. Among~     those patients, only 8% were finally thrombolysed, because of extended management times..~     Our hypothesis was that public awareness campaign designed to improve public's knowledge and~     skills would consequently reduce prehospital time and favour call to prehospital emergency~     medical services (EMS).~      The investigators will conduct an awareness campaign aimed at the general population, using~     different communication media, the content will be developed based on the results of a~     qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with~     communications professionals. To assess the effects of this campaign, a comparative~     quasi-experimental before-after study will be conducted. A control region where no awareness~     stroke program has been set up has been selected, data will be collected in the two regions.~     The assessment of the impact of the campaign will focus on the comparison of the evolution~     of indicators between these two regions. Three assessment time will be provided: before~     starting the program, at 3 months and at the end of the program.~   "
16117|NCT02846350|"~     This study proposes to assess the impact of a provider-based intervention to enhance~     re-engagement and improve retention, adherence, persistence and viral load among challenging~     patients in Argentina~   "
16118|NCT02846337|"~     Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney~     failure induced by a chronic heart failure. Sodium overload is one of the main causes~     leading to the occurrence or the exacerbation of this syndrome. Some patients have a massive~     sodium retention on which medications are not effective enough. These patients have no~     further therapeutic options because of the refractory congestion and a 3-months mortality~     rate around 15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an~     excessively impaired quality of life.~      For those refractory heart failure with cardio renal syndrome, nephrology departments resort~     to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated~     ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in~     this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National~     Authority of Health recently published new Good Practice Guidance thereupon, strengthened by~     the increasing number of publications and the widespread use of this technique. There is~     therefore a consensus among professionals about the benefits of such a technique in those~     indications. However, bibliographical data are not strong enough to support a strong level~     of evidence. None of foresight strategies have been compared to others in a proper~     randomized controlled trial, and there is no clue about any suspected superiority from one~     strategy to another.~      So far, the investigators propound invasive, expensive and not validated techniques to~     patients with functional and vital prognosis altered. The investigators think it's essential~     to prove the efficacy of such an approach. They wish to quantify those techniques impact on~     rehospitalization, with a consideration for the potential survival impact.~      It seems unethical to evaluate separated techniques, taking in account that patients with~     severe heart failure will switch from one technique to another among their care. It is~     therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal~     dialysis, isolated ultrafiltration) compared to a medication-restricted care.~   "
16119|NCT02846324|"~     This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF~     subjects will be randomized to receive GBT440 or Placebo orally daily.~   "
16120|NCT02846311|"~     The rapid and accurate detection of influenza virus in respiratory specimens is required for~     optimal management of patients with acute respiratory infections. Because of the variability~     of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of~     influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza~     diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic~     acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza~     A&B assay in comparison with the routine Xpert Flu/RSV assay.~   "
16139|NCT02846064|"~     Ovarian cryopreservation is one of the available option for preserving fertility prior to~     potentially sterilizing treatments. In the absence of other techniques such as in vitro~     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used~     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was~     obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency~     of the graft in terms of restoration of ovarian function and live births. It will also allow~     us to carry out the patient follow-up after ovarian tissue cryopreservation and after~     autograft when achieved. In cases of neoplastic malignancies, minimal residual disease~     detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.~   "
16140|NCT02846051|"~     Compare the frequency of varicose veins in the lower limbs in a population exposed to~     intensive sport compared to individuals matched by sex, age and body mass index (BMI) did~     not have an intensive sport.~   "
16121|NCT02846298|"~     Since the discovery of streptomycin in 1944, aminoglycosides retain a remarkable~     bactericidal activity vis-à-vis including aerobic gram-negative bacilli. Thus, their~     synergistic effect with beta-lactams and their rapid bactericidal on many make unavoidable~     pathogens and make it a cornerstone of the treatment of patients with severe sepsis or state~     of septic shock.~      This is antibiotics exclusively parenteral administration. Their effectiveness is~     concentration-dependent and are administered by 30-minute infusion. Tolerance of venous is~     usually excellent. Their potential nephrotoxicity or cochleovestibular toxicity requires~     accurate monitoring of antibiotic residuals.~      Moreover the fact that the effectiveness of the aminoglycosides is concentration dependent,~     the rate at the peak is decisive. A first sub-therapeutic dose leads to adaptively resistant~     bacteria compared to the aminoglycoside and therefore an increase of Minimal Inhibitory~     Concentrations (MIC). Many studies have been conducted in patients hospitalized in intensive~     care, highlighting underdoses in aminoglycosides when the prescribed dosages consistent with~     those used in non reanimated patients. Dr Moore showed in 89 ICU patients with bacteremia~     gram-negative bacilli, the relationship between the clinical course and obtaining whether~     therapeutic levels during the first administration of aminoglycosides. Thus, mortality in~     patients whose antibiotic concentrations to peak were subtherapeutic, amounted to 20.9%~     against 2.4% when concentrations were within the therapeutic range. In the context or an~     initial peak in the PK / PD ( Pharmacokinetic / Pharmacodynamic) objectives namely Cmax /~     MIC ≥ 8-10 desirable, individualized therapeutic drug monitoring and identification of~     factors that may cause a concentration of antibiotic at sub-therapeutic peak seems necessary~     , in patients for the majority an increased volume of distribution.~      In addition to the β-lactams and glycopeptides, due to the increased volume of distribution~     in critically ill patients in sepsis, evaluation of serum 24 hours after starting treatment~     to check that the PK / PD goals for these molecules is achieved.~   "
16122|NCT02846285|"~     The various causes of bleeding Proctological are well known to gastroenterologists in~     clinical practice but their proportions have not, to our knowledge, been dedicated~     epidemiological studies. Investigators wanted to evaluate this data as part of a specialized~     consultation. Investigators have prospectively collected the causes of gastrointestinal~     bleeding down the patients seen two of us in specialized proctology center. A clinical~     examination including an inspection, palpation and feel, and a anoscopy (when possible) were~     made during the consultation. Local levies referred (s) histological and / or infection were~     also carried out if necessary. When she had not been made, a colonic exploration was offered~     to all patients over 45 years and / or when indicated by the pathological context. When~     there were several possible causes, the clinician holding one that seemed to be the main.~     Patients consulting within four months postoperatively a proctology action were not~     included. The study period extended from September 2013 to July 2014 inclusive. The~     collection of anonymous data.~   "
16123|NCT02846272|"~     To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative~     workup of children with intractable epilepsy referred for surgery.~   "
16124|NCT02846259|"~     The first purpose of this study is to find out the clinical benefit and risk of oral aspirin~     for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in~     patients in the real world.~      The second purpose of this study is to get the prediction model of aneurysm's rupture in~     patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral~     ischemia , and find out who is suitable for oral aspirin.~   "
16125|NCT02846246|"~     Current home care service are to a large extent task oriented with a limited focus on care~     recipient's involvement. Furthermore, studies have shown that low care recipients'~     involvement might decrease older people's quality of life. Person-centred care focusing on~     involvement has improved the quality of life and the satisfaction with care for older people~     in health care and nursing homes but there is a lack of knowledge about the effects and~     meaning of a person-centred interventions in aged care at home. Present study describes the~     evaluation of a person-centred and health-promoting intervention.~   "
16126|NCT02846233|"~     In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are~     instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as~     the most advanced therapy. However, a significant number of these patients continue to have~     poor diabetes control. The most common reason is the noncompliance with multiple injections~     and the patient's reluctance to accept insulin-induced weight gain. More recently, the~     algorithm in diabetes management has significantly changed to accommodate the newer~     generation of medications. Addition of the diabetes medications, that can induce weight loss~     such as oral Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like~     peptide (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended~     before the patient is advanced to MDI. This approach works very well in most patients since~     weight loss gives the patients an extra motivation to take medication regularly. Similarly,~     the patient does not require to take an insulin injection before each meal throughout the~     day in this approach.~      Unfortunately, there are still a large number of patients with poor glycemic control who are~     still on MDI. Some of them were initiated on MDI before the availability of newer~     generations of medications. Some were started simply because the physician was not aware of~     or not the familiar with the new recommendations. Regardless of the reason, these patients~     are likely to remain on MDI despite chronic poor glycemic control since the physicians are~     understandably reluctant to step down the most advanced insulin therapy. In addition, there~     has been no data on the benefits and safety of the stepping-down approach from the most~     advanced insulin therapy to the more patient-friendly approach that is the combined use of~     oral SGLT2i and once-weekly GLP1 RA injection.~   "
16127|NCT02846220|"~     Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of~     cardiovascular disease and premature deaths in the world. Despite availability of effective~     drugs to control blood pressure, uncontrolled blood pressure and low adherence to~     antihypertensive drugs persist as major public health and clinical challenges. On average,~     50% of adults adhere to chronic disease medications and lower levels of adherence are~     associated with worse blood pressure control and adverse outcomes. Many barriers to~     adherence are well known and have been targeted in interventions to improve medication~     adherence. As of yet, no single intervention has emerged as superior or even particularly~     effective in improving adherence. The investigators have recently identified unconscious,~     self-protective 'hidden motives' that contribute to nonadherence to chronic disease~     medications. There is a critical need to expand on this insight to test the potential for~     targeting individuals' 'hidden motives' for low adherence using an innovative learning~     process called Immunity-to-Change.~      As a critical step in testing this intervention to target these 'hidden motives', the~     investigators will undertake a pilot study to assess the feasibility and acceptability of~     the Overcoming Immunity-to-Change intervention and determine effect sizes of the~     intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The~     investigators will test the Immunity-to-Change intervention in a sample of nonadherent older~     adults with hypertension (n=18). Another sample of nonadherent older adults with~     hypertension will be monitored for comparison (n=18).~   "
16128|NCT02846207|"~     This clinical research is based on the fundamentals of using Chinese medicine, which will~     improve Qi and promote blood circulation, to treat patients in the recuperating stages of~     cerebral infarction with deficiency in Qi and blood stasis syndrome. By assimilating Chinese~     medical theory, this research aims to study the biological basics of the stroke and the~     cause for the deficiency in Qi and blood stasis syndrome; explore the therapeutic mechanism~     of the treatment methods; as well as ascertaining the relationship between Qi, blood and~     blood vessels.~   "
16129|NCT02846194|"~     The purpose of this study is to determine the effect that the Brief Guided Imagery (BGI)~     technique has on fibromyalgia patients suffering from chronic pain in regards to their sense~     of pain, wellbeing and quality of life.~      This study will explore whether daily training of one to two minutes exercises in Brief~     Guided Imagery can reduce chronic pain and improve the quality of life of patients by~     studying specifically patients suffering from fibromyalgia.~      Chronic pain is a common condition which affects person's physical and mental health. It~     occurs in between 10% to 40% of the population, depending on the exact research and chosen~     sample. In 2010 Manchikant et al. found an effect chronic pain has on human functioning and~     quality of life.~      A research from 2007 defined chronic pain as pain that lasts more than three months. Being~     long lasting by its nature, chronic pain has an ongoing effect on deteriorating the quality~     of life. In this regards, quality of life is scientifically determined by five modes: i.~     Physical wellbeing. ii. Mental wellbeing. iii. Social wellbeing. iv. Emotional wellbeing,~     and v. sense of development and self-realization.~      Chronic pain damages daily ongoing functions and is also related to sleep disturbances,~     stress and unemployment. A direct correlation was also found between chronic pain and~     psycho-social .~      One of the many results of chronic pain is the huge impact on the economy, such as absence~     from work due to sick leaves. The overall cost of chronic pain was found to be one percent~     of the total expense on health. The frequency and impact of chronic pain is such that some~     professionals define it as an epidemic.~      In many cases, chronic pain occurs with patients suffering from a wide spectrum of medical~     disorders. In 2007 Tunks et al. demonstrated that chronic pain often accompanies an illness~     that involves also a psychological aspect.~      Both Baird et al. in 2004 and Menzies et al. in 2012 found a significant positive effect~     daily guided imagery exercises have on chronic pain. The study proposes to research the~     specific technique of Brief Guided Imagery on chronic pain, and will focus on patients~     suffering from fibromyalgia.~      Fibromyalgia is a syndrome where a patient suffers from both chronic pain and a fatigue. The~     pain of fibromyalgia is characterized as abstract and non-localized, while the fatigue~     appears in a varying range of intensity. These symptoms are often accompanied by exhaustion,~     lack of energy, somatic disorders and psychologic symptoms such as depression.~      The ongoing pain, fatigue and depression cause fibromyalgia patients to further suffer from~     sleep disorders and diminishing ability to function. Menzies et al. studied in 2012 the~     effect of guided imagery exercises on the stress level, pain, fatigue and depression. The~     study also examined different physiologic blood markers (such as proteins, cytokines and C~     reactive.~      Menzies found a positive and significantly large improvement in the ability to control both~     stress and pain levels, and treat the depression of the participants. However, no~     significant changes were observed in the blood tests monitoring the levels of physiologic~     markers in the blood.~   "
16130|NCT02846181|"~     The primary objectives of the study are:~        -  To assess the mass balance recovery after a single PO dose of [14C]-SK-1405~        -  To provide plasma, urine and faecal samples for metabolite profiling and structural~          identification~   "
16131|NCT02846168|"~     The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major~     adverse cardiovascular events (MACE) in patients with acute myocardial infarction who~     undergo percutaneous coronary intervention.~   "
16132|NCT02846155|"~     By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the~     investigators hope to find out the optimal gastric preparation plan.~   "
16133|NCT02846142|"~     This trial will consist of three parts: the first two parts will enroll healthy female~     volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment~     groups.~      The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized~     to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A~     total of 24 subjects are anticipated to participate in this part of the study.~      Following the conclusion of the respective SAD level dose groups and after sufficient review~     of study data and approval by the SRC, a second set of healthy adult female subjects will~     participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3~     cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed~     for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate~     safety, PK and other relevant data. The SRC will determine whether to proceed to the next~     planned dose level, to reduce the dose, or to stop the study. The next cohort may commence~     only after written SRC approval. A total of 24 subjects are anticipated to participate in~     this part of the study.~      Following completion of the SAD and MAD, 40 female healthy volunteers will participate in~     two treatment periods of the DDI study component: Treatment period A will consist of once~     daily oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).~      Treatment period B will randomize subjects to PTI-428 or placebo in combination with once~     daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following~     completion of the subjects' second treatment period, they will be followed for 7-days after~     their last dose.~   "
16134|NCT02846129|"~     Incidence of anesthesia related complications in multiple gestation patients undergoing~     cesarean delivery has not been reported in Thailand. The aim of this study is to identify~     complications that occur which may derived from different anesthetic techniques used, such~     as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood~     transfusion and fetal outcome.~   "
16135|NCT02846116|"~     The aim of this study is to evaluate using of new ceramic material Vita Suprinity and~     lithium disilicate on patient satisfaction combined with shade matching.~   "
16136|NCT02846103|"~     Increasing evidence suggests that immune responses might be a determining factor in lung~     cancer tumor progression.~      The impressive clinical responses obtained with immune checkpoint inhibitors~     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune~     response is required for their efficacy and highlight the critical role of antitumor T cell~     immunity. Recent progress on the fields of tumor immunology underlines the critical role of~     CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity.~     Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.~      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the~     investigators group have previously described novel promiscuous peptides (referred as~     UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared~     tumor antigen.~      By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected~     in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this~     response were inversely correlate to the disease stage. Furthermore, UCP-specific responses~     were significantly found in patients with low PD1+ and TIM3+ T cells.~      Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer~     before and after treatment (chemotherapy, immunotherapy).~   "
16137|NCT02846090|"~     Nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown~     a huge increase . This is because of the increase the geriatric population in the community~     and advanced medical care. Surgical correction, as a treatment, solves this problem greatly~     especially with the modern surgical techniques .~      Peribulbar block reduced the admission discharge time and reduced the burden on both the~     patients and the medical team. On the other hand, it carries the risk of increased~     intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery.~      Dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing~     intraocular pressure (IOP). This effect has been shown at a histological level and clinical~     level~   "
16246|NCT02844673|"~     To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU~     (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.~   "
16141|NCT02846038|"~     Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents~     of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and~     ensuring that medical management aligns with the families' goals of care. Communication is~     particularly important during conversations about disease reevaluation, which often~     necessitate parental decision-making in the context of emotional distress. POs employ a~     spectrum of communication styles and strategies during challenging conversations, and there~     is no consensus regarding linguistic or thematic metrics for high quality communication of~     upsetting information. In order to better understand how POs communicate difficult~     information to POCCs, the investigators propose a pilot study designed to accomplish the~     following primary aim:~      Primary Objective:~        -  To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence)~          communication techniques employed by POs in the delivery of difficult prognostic~          information to POCCs through content analysis of audio-recorded conversations between~          POs and parents of children with high risk cancer at the time of disease reevaluation.~      The study expects to enroll up to: 30 patient participants, 30 parents, 6 primary pediatric~     oncologists, 30 non-primary oncologist care team members, 30 extended family members, and 30~     friends of the family (total = 156).~   "
16142|NCT02846025|"~     ABSTRACT~      Epigenetic mechanisms may be involved in the regulation of lipid metabolism and inflammatory~     markers may therefore contribute to the cardiovascular risk profile, as well as~     environmental factors have a significant impact on the epigenetic program of gene~     expression. Methyl groups are usually added or removed as needed and can be influenced by~     diet soon, dietary factors have been linked to the change of DNA methylation, resulting in~     changes in gene expression. Research on the prevalence of gene methylation levels on the~     impact of nutrient intake, as well as the inflammatory condition and the results of dietary~     interventions for the genes, it is a sparse area in studies and, therefore, expanding of the~     knowledge. Thus, understanding the effects of a diet rich in antioxidants and hazelnut oil,~     in inflammation and DNA methylation profile is important because chronic diseases with~     cardiovascular disease can begin with the consumption of modified lipids and can research~     this stage provide important dietary allowances for the development of this disease~     prevention strategies even in adulthood. This PhD project is linked to a larger project~     entitled II Diagnosis Cycle and Intervention Food Situation, Nutrition and Noncommunicable~     Diseases Prevalent over the City Population of João Pessoa / PB (II DISANDNT / PB) and have~     two methodological designs: the first one is the composition of a representative sample of~     adults in the city of João Pessoa, from II DISANDNT / JP, population-based study and~     cross-sectional. The second methodological design was developed with a subsample of the~     above population, selected from criteria being the type and interventional clinical trial.~     This model will have to evaluate the effect of a diet rich in antioxidant and hazelnut oil,~     in inflammation and gene expression.~   "
16143|NCT02846012|"~     The purpose of this study is to collect development and outcome data on human embryos which~     are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective~     to demonstrate its performance efficacy in comparison to existing commercially available~     single culture or continuous embryo culture media.~   "
16144|NCT02845999|"~     Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances~     in GI cancer treatments, the 5-year overall survival rate for these patients remain~     unacceptable, except for patients who are candidates for metastasis surgical resection.~     Strategies leading to a decrease of metastatic number and size will contribute to improve~     the probability to undergo a curative surgical procedure.~      Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive~     transfer and may have a role in the treatment of selected malignancies, since the failure to~     recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell~     elimination of that target cell. NK also express an activating Fc receptor that mediates~     antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory~     cytokines in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal~     antibody against colorectal cancers that expressed EGFR (epidermal growth factor receptor),~     improves overall survival and progression-free survival and preserves quality-of-life~     measures in patients with colorectal cancer in whom other treatments have failed.~      In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical~     trial assessing NK cell based immunotherapy. Patients with liver metastases related to a~     EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a~     complete response or a curative resection of residual metastases will be included in this~     phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005).~     This phase I/II study will involve 22 patients. The main objective of this study will be to~     demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab.~     Secondary objectives will include the assessment of the clinical efficacity of this~     strategy.~   "
16145|NCT02845986|"~     The purpose of this study is to explore the safety and feasibility of the Laparoscopic~     Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper~     third gastric adenocarcinoma（cT2-4a, N-/+, M0）.~   "
16146|NCT02845973|"~     The aim of the study is to identify and verify one or more gut bacteria of which the~     abundance in feces may help to early diagnosis colorectal cancer.~   "
16147|NCT02845960|"~     The purpose of this study is to evaluate the influence of rapid recovery on sleep quality~     following total knee replacement surgery.~   "
16148|NCT02845947|"~     This study seeks to research the effects of music therapy during pediatric extubation~     readiness trials. Amount of sedation, physiological measures, and parent/staff satisfaction~     surveys will be measured.~   "
16149|NCT02845934|"~     This Study evaluates the performance (sensitivity, specificity, positive and negative~     predictive value values and likelihood ratios) of the DNA detection test for the diagnosis~     of mucormycosis by comparing it to the routine tests such as CT scan aspects,~     histopathology, microscopy and fungal culture, in a test group of 52 patients including :~        -  patients at high-risk according to the EORTC/MSG criteria (patients with prolonged~          severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of~          allogeneic HSCT, or inherited severe immunodeficiency),~        -  patients with other predisposing factors of invasive mould disease ( diabetes, AIDS,~          haematological malignancies or solid tumours, trauma, burns); Patients already~          diagnosed with probable or proven mucormycosis irrespective of underlying conditions.~   "
16150|NCT02845921|"~     Propofol is an intravenous anaesthetic agent used for both induction and maintenance of~     anaesthesia. An important adverse effect is the significant fall in blood pressure. The~     current clinical study will be done to determine the efficacy of leg elevation and wrapping~     in reducing the incidence and severity of propofol induced hypotension in patients~     undergoing general anaesthesia.~   "
16152|NCT02845895|"~     The prevalence of malnutrition in hospital is very high (30 percent) with major consequences~     in terms of morbidity and mortality, generating significant health care costs. The positive~     impact of its support is demonstrated.~      The HAS (High Sanitary Authority) recommends a screening of all adult hospitalized in the~     first 48 hours, with no consensus regarding the organization of screening within care~     services. Various strategies have been implemented. Although this screening is part of the~     nursing role, old and recent studies show that it is not done systematically and nutritional~     disorders are largely under-diagnosed and therefore untreated.~      The investigators assume that an organization of screening for eating disorders, based on a~     caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour~     l'Amélioration de la Qualité et de la Sécurité des Soins witch is an indicator for the~     improvement of the quality and security of care) Screening indicator of nutritional~     disorders Level 3, compared to an organization classic involving the care teams in their~     entirety. This indicator reflects the care system performance.~      In this study, patients will have no intervention. Only the organization of the care staff~     will be adapted but with no changes on the care of patients~   "
16153|NCT02845882|"~     The outcomes of children with lymphoblastic lymphoma (LBL) in China in the investigators'~     previous study were not unexpected. In this study, through further modification treatment~     protocols and strengthen domestic multicenter collaboration, the investigators try to~     improve survival for children with LBL when compared to the previous study.~   "
16154|NCT02845869|"~     During basic training, 15% of military recruits develop knee pain, which hinders their~     chance to complete training. Current therapeutic options have had variable levels of~     success. Light therapy was shown to reduce pain in chronic inflammatory related knee~     pathology. The current clinical study is designed to evaluate light therapy, as an adjunct~     to conservative physiotherapy for treatment of acute overuse KP in combat soldiers.~   "
16155|NCT02845856|"~     The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK)~     immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.~   "
16156|NCT02845843|"~     This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety~     of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with~     MERS.~   "
16157|NCT02845830|"~     Maintaining of improving the quality of life amongst the elderly with early phase dementia~     (EwD) is nowadays one of the key aims of health care services. When investigating the~     quality of life trajectories, it is necessary to examine contributing factors. The aim of~     the project is to ascertain the profile of quality of life trajectory amongst Czech EwD and~     to identify the most important factors affecting it. The results will be compared to the~     results from the elderly without dementia. A quantitative approach, longitudinal prospected~     design utilising a battery of questionnaires in the Czech language will be used. At the same~     time, translation and validation of the Czech version of QOL-AD and PDI will be carried out.~     The group of respondents will include EwD and elderly without dementia living in home~     environment. Knowledge of the quality of life trajectory and the factors involved will~     enable interventions to maintain or improve the quality of life of the elderly with~     early-stage dementia in home environment in future. Project Aims The aims are to ascertain~     the quality of life trajectory profile amongst the elderly with early phase dementia, to~     identify the most important factors involved and to compare the results to control group.~     Validation of the Czech versions of QOL-AD and PDI questionnaires will be performed.~   "
16158|NCT02845817|"~     This study take place in the palliative care units of Burgundy-Franche-Comté regions and at~     the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and~     understand the meaning of explicit requests to hasten death (euthanasia and assisted~     suicide).~      This involves conducting interviews with patients, carers to whom the request has been~     expressed and a relative chosen by the patient. This study aims to describe the request over~     time. This will be done through two series of interviews, one as soon as it is first~     expressed, then one week later.~   "
16159|NCT02845804|"~     The objectives of this study are~        1. To establish a prospective registry of the whole patients who received percutaneous~          coronary intervention with Xience Xpedition™/Alpine™ stent~        2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience~          Xpedition™/Alpine™ stent~        3. To compare the long-term efficacy and safety of coronary stenting between the Xience~          Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had~          established their own registry~   "
16160|NCT02845791|"~     To investigate whether the interactive family based lifestyle programme leads to behaviour~     change at 6 months with the primary outcome being increased levels of moderate to vigorous~     physical activity (MVPA).~   "
16161|NCT02845778|"~     Melatonin is an endogenous hormone. It is able to promote nighttime sleeping and could~     induce sleep at daytime in adult and children with the nonpainful diagnostic procedure.~     However, previous formulation had problems of unstability of product and low oral~     bioavailability. Melatonin niosomes oral gels are formulated in order to overcome the~     problem of drug absorption and stability. This study is a randomized, double-blind, three~     phase crossover design in 15 male volunteers. Melatonin niosomes oral gel will be applied at~     doses 2.5, 5, and 10 mg with 7 days washout for each period. The pharmacokinetics data,~     sleep induction effect, and adverse event will be determined.~   "
16162|NCT02845765|"~     The purpose of this study is to evaluate the correlation between fundus oculi's~     vascularization in patients with erectile dysfunction and not, and, in the same patients,~     before and after using drugs for ED.~   "
16163|NCT02845752|"~     The purpose of this study is to determine whether exercise can be prolonged in COPD can by~     the inhaled bronchodilator Stiolto Respimat. The study will identify whether any endurance~     benefit is due to reduction in fatigue that originates within the skeletal muscles and/or~     from effects on neural activation of the skeletal muscles.~   "
16164|NCT02845739|"~     The main goal of project is to study the distribution of HPV genotypes in the anogenital~     area and peripheral humoral immune responses HPV (total and neutralizing Ab) before and~     after renal transplantation. Furthermore, the investigators wish (i) establish whether there~     is a correlation between HPV infection and HPV immune response before and after~     transplantation, and (ii) determine whether there is a link between HPV infection and~     immunosuppression.~   "
16165|NCT02845726|"~     This study is performed to analyze various aspects of biofilms on ureteral stents.~   "
16166|NCT02845713|"~     The study will be an open label cohort study with 2 two-treatment groups 2). Both groups~     will be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg +~     Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will~     include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment~     group will include men and women who are free of W. bancrofti infection based on negative~     blood tests for both microfilariae (Mf) and circulating filarial antigen (N=30). Active~     follow-up for adverse events (AE) will be for 72hrs and passive follow-up for 7 days~     following treatment.~      Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals~     with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital~     and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis~     (LF) infected individuals any AEs develop within the first 72 hours following treatment and~     uncommonly up to 7 days post-treatment.~      All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.~      Subjects will be monitored for 72-hours after treatment for safety and to facilitate~     sampling for drug analyses and safety tests. Participants will undergo clinical monitoring~     every 6 hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine +~     Albendazole (IDA) treatment. Participants will also be monitored for hematologic, or~     biochemical abnormalities during the period of observation.~   "
16167|NCT02845700|"~     The study will use a prospective design consisting of three phases. The phases are:~        1. the development of the sensory retraining treatment (SRT),~        2. the evaluation of the treatment's feasibility and acceptability, and~        3. an assessment of its efficacy.~      During the third phase, a pilot study will be conducted in which participants will be~     randomly assigned to either SRT or a waitlist control group in order to assess efficacy.~     Diagnostic information and eligibility criteria will be assessed using the Structured~     Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale for DSM-5~     (CAPS-5).~   "
16168|NCT02845687|"~     The purpose of this study is to conduct an observational assessment of natural outcomes~     within the Duke Smoking Cessation Program (DSCP), Quit at Duke. This assessment will~     include information regarding abstinence rates, changes in patient emotional state following~     treatment, and costs of operations. Primarily, this study will assess the financial~     sustainability and the cost-effectiveness of the program.~   "
16169|NCT02845674|"~     This is a safety extension enrolling subjects participating in Study OTX-101-2016-001~   "
16170|NCT02845661|"~     Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and~     sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain~     cooperative and can be easily aroused. This study was designed to explore the correlation of~     Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses~     of dexmedetomidine intravenously.~   "
16171|NCT02845648|"~     To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with~     anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic~     enuresis and evaluate the potential implication of improved AA for treatment response~     prediction.~   "
16172|NCT02845635|"~     The purpose of this study is to better characterize the fluctuations in multiple sclerosis~     symptoms and their relationship to medications, to length/extent of disease, and to a~     variety of physiologic measures.~   "
16173|NCT02845622|"~     This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on~     vascular reactivity and metabolic profile. Participants, divided in six groups, will receive~     one of these breakfast integrations for 14 days:~      group 1) 30 g peeled hazelnuts;~      group 2) 30 g unpeeled hazelnuts;~      group 3) snack with 30 g peeled hazelnuts;~      group 4) snack with 2.5 g cocoa powder;~      group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;~      group 6) empty snack, control group.~   "
16174|NCT02845609|"~     Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release~     formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is~     currently studied as a substrate replacement therapy for patients with GNE myopathy. The~     investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related~     thrombocytopenia.~   "
16175|NCT02845596|"~     The purpose of this study is to determine the feasibility of comparing outcomes of patients~     treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD)~     hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.~   "
16176|NCT02845583|"~     the study consists of an observational study aimed at quantifying the economic burden of the~     nursing activities on the overall cost of hospitalizations funded through DRG tariffs for~     Major complexity oncology patients.~   "
16177|NCT02845570|"~     Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect~     granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this~     PET tracer, including identification of subclinical disease in latently infected~     individuals. This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect~     pulmonary lesions in individuals with active pulmonary tuberculosis.~   "
16178|NCT02845557|"~     Early onset type 2 diabetes mellitus among adolescents/youth (YT2DM) is a rising phenomenon.~     The pathophysiology has been studied primarily on non-Asian populations while literature on~     incretin effect is scarce. The investigators evaluated insulin sensitivity, beta-cell~     function, incretin hormones and their effect in YT2DM from a multiethnic Malaysian~     population. The characterization of this population may enable us to better tailor their~     antidiabetic care.~   "
16200|NCT02845271|"~     Primary Objective:~      To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for~     relief of knee pain in patients with osteoarthritis (OA) of the knee.~      Secondary Objectives:~      To assess the safety and tolerability of a single intraarticular dose of GZ389988 in~     patients with painful OA of the knee.~      To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in~     patients with painful OA of the knee.~   "
16247|NCT02844660|"~     A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine~     the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for~     the treatment of chronic, non-healing diabetic foot ulcers (DFUs)~   "
23534|NCT02749136|"~     The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant~     modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable~     pancreatic cancer.~   "
16179|NCT02845544|"~     The study of the behavior of the mechanisms of body balance with a workout based on the~     Pilates method can facilitate the development of more accurate rehabilitation approaches.~     However, there is still little scientific information on its effects on the locomotor system~     and it's necessary to search for new methods to evaluate its strategies more specifically.~     Thus, this study aims to determine whether an exercise program based on Pilates method has~     influence on the static and dynamic postural balance of sedentary adults. This is a~     randomized controlled trial, which will be developed with an initial sample of 20 subjects~     of both sexes, aged between 18 and 30 years, divided into two groups: a control group and an~     experimental group. Participants with physical activity time up to 150 minutes per week will~     be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those~     who have no experience with the Pilates method. In the experimental group a workout program~     will be done for 6 weeks with individual classes including exercises based on the Pilates~     method, during 1-hour, twice a week. Assessments will be made prior and after the training~     program with anamnesis, anthropometric measurements and also the Balance Error Scoring~     System and the Star Excursion Balance Test Y to assess postural balance. During the tests~     and training program exercises the muscle activity of paraspinals and transversus abdominis~     will be analyzed using surface electromyography (sEMG), and body mass center displacement~     will be measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The~     data will be entered in a spreadsheet and statistically tested with SPSS software. The tests~     will include the comparison of means, association, correlation and effect size, which will~     be chosen according to the distribution of the data and will use the 5% significance level~     for all tests.~   "
16180|NCT02845531|"~     The purpose of this study is to determine whether ICD(Implantable Cardioverter~     Defibrillator) implantation on the top of optimal medical therapy in patients with variant~     angina manifesting as aborted sudden cardiac death reduces the incidence of the death from~     any cause compared with optimal medical therapy alone.~   "
16181|NCT02845518|"~     Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in~     pulmonary vascular resistance leading to right ventricular (RV) failure and eventually to~     death. The therapeutic strategy has become complex and needs to perform recurring follow up~     evaluations including a right heart catheterization (RHC).~      Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right~     ventricular (RV) volumes and important prognostic predictors such as cardiac index, stroke~     volume (SV) and right ventricular ejection fraction (RVEF).~      The main objective is to assess the hemodynamic diagnosis performances (sensibility and~     specificity) at baseline and at follow up visits of cMRI to detect an unfavorable~     hemodynamic status in comparison with the results of the RHC (current guidelines).~      The primary endpoint is: sensitivity and specificity of cMRI for the diagnosis of an~     unfavorable status defined by the current RHC criteria (with 95% confidence interval).~      The secondary objectives are: to identify clinical and hemodynamic variables independently~     contributing to prognosis, to quantify complications due to cMRI and to RHC and to compare~     acceptability and tolerability of cMRI over RHC for the patient.~      PAH patients will be recruited in 18 centers of the French network of severe pulmonary~     hypertension in a prospective cohort study.~      180 subjects will be enrolled in the study: that size will give the study 90% power to find~     significant at the 5%-level.~      If the primary endpoint were reached, since first, strategies and procedures planed in this~     project are consistent with those currently used in routine and second, inclusion criteria~     are not limited to a sub-population of PAH patients, positive results could allow to broadly~     extending our findings. Therefore, it will be possible to decrease the number of RHC, an~     invasive and cumbersome procedure without altering the prognosis. Moreover all clinical~     procedures would be performed in outpatient clinics and thereby would reduce the cost to~     assess the severity of the disease. Current recommendations for evaluation of severity and~     follow-up being mainly derived from consensus of opinion of the experts, positive results~     will also improve the level evidence of severity assessment of PAH patients.~   "
16182|NCT02845505|"~     The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial~     territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of~     CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the~     IVUS information about myocardial territory and stenosis severity and predicts the extent of~     CAMS-derived myocardial size.~   "
16183|NCT02845492|"~     This study compares Qigong movement-based meditation exercise with a healthy living~     exercise-wellness course. There are two primary goals of this research:~        1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise~          interventions with the specific goal of understanding the physiology of Qigong.~           Using a simple noninvasive EEG setup, the study will test some of the same brain~          mechanisms that have been found in mindfulness meditation.~           The study will also investigate Qigong's effects on stress and heart signals and on~          inflammation in the immune system. A key hypothesis is that Qigong will show~          distinctive, stronger effects on brain and heart measures. A related hypothesis is that~          Qigong will show stronger effects on blood markers of inflammation.~        2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan~          for a larger clinical trial.~   "
16184|NCT02845479|"~     Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative~     care intervention delivered by naturopathic doctors in conjunction with standard surgical~     and oncologic care of people with thoracic cancer.~   "
16185|NCT02845466|"~     Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or~     more months to heal. Growth factors have been used to try and improve this healing, however,~     many such studies have failed, and that is thought to be due enzymes in the wound that~     degrade the growth factors and prevent them from working. This is a proof of concept study~     that will evaluate the treatment of chronic leg ulcers with topically applied growth factors~     that are combined with a therapy to prevent their inactivation in the wound.~   "
16186|NCT02845453|"~     The purpose of this study is to determine whether quetiapine is effective in the treatment~     of youth with co-occurring substance use disorders and bipolar disorder.~   "
16187|NCT02845440|"~     The overall aim of this study is to test the effect of academic detailing (i.e.~     provider-level educational intervention focused on evidence-based smoking cessation~     treatment for those with psychiatric illness), alone or in combination with practical~     support from a community health worker, on the provision and utilization of standard of care~     smoking cessation treatment to those with serious mental illness (SMI). Further, this study~     will determine if these interventions improve smoking cessation rates for adults with SMI~     who smoke.~   "
16188|NCT02845427|"~     Comparative randomised study to clarify which better to use or no use of closed suction~     drain system after total hip arthroplasty regarding amount of blood loss, need for blood~     transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early~     post-operative rehabilitation. Patients will be followed up for one month postoperative~     clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view~     plain x-ray of the hip).~   "
16189|NCT02845414|"~     This is a single center, phase I dose escalation study designed to determine the maximum~     tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL~     (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients~     with advanced, previously treated, refractory solid tumors.~   "
16237|NCT02844790|"~     This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart~     in healthy Chinese subjects.~   "
16190|NCT02845401|"~     The investigators' research is aimed at developing more effective, finite approaches for~     managing individual patients with chronic hepatitis B (CHB). This prospective clinical and~     basic scientific study exclusively focuses on patients with the early antigen negative form~     of disease, which in developed countries is treated indefinitely with antiviral drugs. The~     investigators' study BeNEG-DO, directly offers patients who are already taking standard~     oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or~     continue treatment. Drawing on data from pilot studies, including the investigators' own~     University of California, San Francisco and Sutter Institutional Review Board-approved~     study, the investigators will examine a finite HBV treatment strategy on clinical outcome~     and safety. In conjunction, the investigators will study immunologic mechanisms and gene~     expression profiles that correlate with and predict the post-treatment clinical course. The~     BeNEG-DO study could seriously question, and potentially change, the current treatment~     paradigm for millions of patients with CHB and also lead to new disease-terminating~     antiviral therapeutics.~   "
16191|NCT02845388|"~     Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate~     alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.~   "
16192|NCT02845375|"~     In this study the investigators will assess (i) the effect of partial neuromuscular blockade~     (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to~     isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by~     sugammadex, neostigmine or placebo in healthy volunteers.~      Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced~     by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from~     TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy~     volunteers.~   "
16193|NCT02845362|"~     Measurements of dysphagia severity are important when making management decisions and in the~     objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a~     validated self-report inventory using a visual analogue scale. This questionnaire permits a~     quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia~     in different pathology. Opposed to largely used videofluoroscopy swallowing study and~     endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure~     and enables a readily available assessment. Validated French version is not yet available.~     In the first phase of the study the investigators will validated this translation in~     dysphagic patients and control. Secondly, the investigators will validate the SSQ in~     Neuromuscular patients.~   "
16194|NCT02845349|"~     Traumatic brain injury (TBI) is a major public health problem with an annual incidence of~     about 1.7 million per year. TBI is associated with various long-term morbidities. Among~     them, psychiatric disturbances are the major cause of chronic disability and poor quality of~     life. Major depression is the common psychiatric sequela post TBI with rates ranging from~     13% at 1 year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred~     to as TBI depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such~     as anxiety, aggression, substance abuse and cognitive deficits that often makes treatment~     difficult. Despite increased rates of depression, there is no Food and Drug Administration~     (FDA) approved drug/s for its treatment.~      The investigators propose to address these limitations by use of a novel serotonergic agent,~     vortioxetine, which has a multimodal mechanism of action through serotonin transporter~     (SERT) inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor~     partial agonism, and 1A receptor agonism.~      Overarching Goal: The overarching goal of the proposed pilot study is to determine the~     effectiveness and safety of vortioxetine for the treatment of post-TBI depression and~     co-morbid NPS.~      Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who~     meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for~     screen failures. Written informed consent will be obtained from these patients. Subjects~     will be followed for a total of 12 weeks. Subjects will be randomized to either the~     vortioxetine arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine~     10mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically~     necessary, at week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1~     or 2 visits) and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric~     instruments will be used to compare the effectiveness of vortioxetine versus placebo~     treatment at week 12 compared to baseline Relevance: This study has the potential to provide~     strong preliminary evidence for the use of vortioxetine as a safe and novel agent for~     treatment of TBI depression and its psychiatric co-morbidities. If found to be effective,~     results from this study can be used to design larger studies and also determine brain~     changes associated with its use via neuroimaging.~   "
16195|NCT02845336|"~     Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks~     orbital tissues, resulting in characteristic changes in eyelid position, globe position in~     the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially~     blinding disease, and current treatments largely consist of nonspecific reduction of~     inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED~     progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital~     changes become fixed and can be modified only by surgery.~      The investigators propose to treat a cohort of patients with active TED using a selective~     COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group.~     The investigators hypothesize that celecoxib will reduce the severity of disease and/or~     prevent progression to proptosis, diplopia, and corneal exposure or compressive optic~     neuropathy.~   "
16196|NCT02845323|"~     This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab~     plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus~     Urelumab, while the other half will receive Nivolumab alone.~   "
16197|NCT02845310|"~     The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke~     volume variation plus a restricted fluid management approach to standard fluid management in~     patients undergoing major abdominal operations.~   "
16198|NCT02845297|"~     This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase)~     of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with~     pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The~     dose/schedule of AZA selected for this study is FDA approved for patients with MDS/AML.~   "
16199|NCT02845284|"~     This randomized clinical trial is an adolescent focused implementation science study~     directed at improved social support and prevention of both HIV/STI's and subsequent~     unplanned pregnancies. The study population is pregnant adolescents who are attending~     antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer~     lead, reproductive health promotion interventions compared to routine health care will be~     studied. The study participants will be individually randomized to one of three arms.~   "
16248|NCT02844647|"~     A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of~     treatment with radium 223. Study participants will undergo anatomical MR imaging combined~     with the new hyperpolarized MRI (1 hour exam) prior to treatment.~   "
16201|NCT02845258|"~     Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case~     of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In~     modern medicine the preferred way to perform such a drainage is by the means of endoscopic~     ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed~     in different scenarios. The cyst appearance and the drainage stents and/or technique may~     impact the clinical outcome.~      This study is a prospective, single-center observational study on the outcome after~     EUS-guided drainage of pancreatic pseudocysts.~   "
16202|NCT02845245|"~     Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of~     high-energy trauma such as motor vehicle collisions or fall from a height. They are complex~     injuries often associated with significant fragment displacement and severe soft tissue~     injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons~     use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and~     displacement. Yet, in some cases, it is still difficult to identify the relationship among~     bone fragments, which often makes articular restoration challenging. As a result, patients~     with non-anatomic joint reconstructions have a higher rate of poor outcomes.~      The primary objective of this study will be to compare patient outcomes in two groups, one~     group who will receive enhanced pre-operative planning (3D printed plastic prototype +~     standard of care [SOC] imaging with 3D CT scan + plain film radiographs) and a second group~     who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film~     radiographs only). Patient outcomes collected throughout the 12 month post-operative period~     will include an assessment of radiographic fracture healing (union, non-union, malunion),~     pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's~     self-report, and development of complications (infection, wound healing, re-operation, and~     re-hospitalizations). The secondary objective of this study will be to evaluate whether~     utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the~     original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs~     only).~   "
16203|NCT02845232|"~     Blood transfusion requirement represents one of the most significant cost driver associated~     with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities~     in older patients, AML in older patients is more often associated with adverse features than~     in younger adults. Physicians might therefore decide to offer palliative or supportive care~     rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy,~     such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best~     Supportive care (BSC). Blood transfusion requirement represents one of the most significant~     cost driver associated with AML.~      The present study assesses the cost-effectiveness of intensive chemotherapy versus Best~     Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose~     cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70~     years or older regarding blood product transfusions from a French payer perspective.~     Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to~     represent the most commonly used treatment for elderly AML according to the defined status~     of patients considered as 'fit' or 'unfit' for intensive chemotherapy.~   "
16204|NCT02845219|"~     This trial is conducted in Europe. The aim of the trial is to investigate the influence of~     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of~     ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy~     postmenopausal females.~   "
16205|NCT02845206|"~     Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads~     to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be~     dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from~     the normal alignment of the limb can lead to abnormal stresses on the implant and~     accelerated failure. Patient specific cutting blocks may result in a more individualised~     implant placement, improved pain and function following surgery, and a long-lasting implant.~      This trial is designed to investigate if there is any benefit to bespoke instrumentation in~     terms of pain and function to the patient, and an economic benefit to the NHS.~   "
16206|NCT02845193|"~     The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents'~     satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve~     and facilitate the surgical procedure after lip closure. This might decrease the need of~     further interventions to improve esthetics and function of CLP patients. This trial will~     help the patients and practitioners in taking the decision of inclusion of NAM in the CLP~     treatment protocol as a mandatory step or skip a useless procedure with all of its burden.~   "
16207|NCT02845180|"~     The purpose of this study is to assess local tissue reaction and retention of an adipose~     allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous~     abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.~   "
16208|NCT02845167|"~     Basic animal research has demonstrated that exercise training can protect the myocardium~     from ischemia-reperfusion injury through several biological mechanisms . This effect of~     exercise training may be beneficial in the perioperative period when cardiac complications~     may arise. However, exercise induced cardioprotection is lost completely within 18 days of~     stopping the training program. This finding from animal research will be used to test the~     hypothesis that 3 days of consecutive exercise with the last bout conducted within the last~     24/48 hours prior to surgery, will have a cardioprotective effect . Specifically, exercise~     has been shown to protect cardiac myocytes against reperfusion induced oxidative stress and~     mitochondria against reperfusion induced damage. This exercise mediated cardioprotection is~     observed in short moderate duration ischemia (i.e. 5-20 min) and moderate to severe~     (i.e.20-60 min) ischemic insults. The effects of exercise induced cardioprotection have only~     been investigated at cell level and it has not been shown whether this will translate into a~     reduction in postsurgical reperfusion injury and associated complications. To study this~     potential cardioprotective effect the investigators will aim to recruit patients who have a~     high risk of receiving reperfusion injury during surgery. Specifically, the investigators~     will recruit abdominal aortic aneurysm patients where the risk of heart complications is~     high. There is also currently no evidence in the published literature with regard to the~     effect of preoperative supervised exercise.~   "
16209|NCT02845154|"~     Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known~     complication in liver transplantation. Several trials investigated variables that my~     contribute to the generation of these two complications for reducing their incidence and~     magnitude. The investigators will investigate the effect of acute conditioning of the~     recipients circulation to the vasoactive mediators in the graft as well as the congested~     intestine through intermittent purging of graft contents into the patient's systemic~     circulation in living donor liver transplantation.~   "
16210|NCT02845141|"~     The overall objective is the histological and radiological assessment of bony consolidation~     of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous~     spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.~      Clinical correlation with the histological and radiological results using the SF36~     questionnaire.~   "
16211|NCT02845128|"~     Multicentric cohort study recruiting patients admitted to the intensive care unit (ICU) with~     acute respiratory failure (ARF) and receiving treatment with high-flow nasal cannula (HFNC).~      This is a second part of the initial study PF(AG)101/2011 where the investigators created~     the ROX index to predict the need of failure with HFNC treatment in patients with ARF~     secondary to pneumonia, and the investigators want to validate ROX index with this second~     prospective cohort results.~   "
16212|NCT02845115|"~     The aging of the population, and greater exposure to noise, are responsible for an increased~     incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that~     has become a real public health problem. The main means of rehabilitation of this disability~     is represented by the apparatus of patients with conventional hearing aids. However, these~     hearing aids have several drawbacks that limit their profits, often abandoning the~     prosthesis by the patient.~      Middle ear implants were developed to answer these problems. They are intended to amplify~     the sound signal by transmitting directly to the middle ear to compensate for the hearing~     loss and are indicated in case of failure or contraindication of conventional equipment.~     However, these middle ear implants currently have limitations as performance failure. Recent~     data show that the performance of the ossicles repair techniques are dependent on the~     coupling of the ossicular prosthesis to the ossicles. Furthermore, advances in the~     understanding of the biomechanics of the ossicles confirm the importance of the placement~     and linkage of surgical restoration processes. This data can be applied to middle ear~     implants to improve performance. Indeed, a preliminary experimental study on anatomical~     parts, using analysis of the vibration of the middle ear structures by laser velocimetry,~     allowed us to define the transducer placement method and coupling method to ossicles.~      We wish to validate in vivo results in a pilot study on a small number of patients by~     comparing two surgical techniques guided by velocimetric measures.~   "
16213|NCT02845102|"~     Depression is common among individuals with chronic illness such as chronic heart failure~     (CHF) or chronic obstructive pulmonary disease (COPD) and is a strong predictor of poor~     clinical outcomes and high rates of avoidable 30-day readmissions. While depression is a~     treatable condition, few people with depression receive effective treatment. The proposed~     study aims to develop a relational agent system to deliver depression treatment to patients~     with chronic illness and comorbid depression. While depression is a treatable condition,~     less than 36% of people with depression receive effective treatment. The proposed study aims~     to design and develop a technology-driven relational agent system to deliver a 6 module,~     blended approach of cognitive behavioral therapy and self-management education (RA-CBT) to~     support patients with CHF or COPD and comorbid depression. The relational agent is a human~     animation program that interacts with patients, integrates best practices from~     provider-patient communication theory, emulating the face-to-face conversational behavior of~     an empathic provider emphasizing nonverbal communicative behavior such as gaze, posture,~     gestures, etc. The RA-CBT program will be accessed via tablet technology by participants.~     The study investigators will conduct a pre-post feasibility study to understand the~     feasibility and acceptability of using the RA-CBT system and its effectiveness in treating~     comorbid depression. If successful, this new approach to depression treatment would~     immediately expand access and scalability for post-discharge mental health support in the~     care transition.~   "
16214|NCT02845089|"~     A retrospective observational longitudinal medical chart review study of randomly sampled~     patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each~     patient will be 12 months.~   "
16215|NCT02845076|"~     Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These~     strategies have yet not been compared to each other. Therefore, the investigators planned to~     perform a prospective, randomized, pilot study involving hypercapnic acute respiratory~     failure patients ready to be weaned off from NIV. The investigators are going to compare the~     success rate of NIV weaning and the duration of NIV after randomization between 3 NIV~     weaning methods: gradual decrease in duration of NIV or level of ventilator support, and~     abrupt discontinuation of NIV.~   "
16216|NCT02845063|"~     The study aims to systematically investigate the interaction between training modality, ACE~     genotype and disease in heart patients whom complete a cardiovascular rehabilitation~     program. This is carried out with the goal to improve the benefit of cardiovascular~     rehabilitation for the patient by maximising adjustments in muscle structure and function~     with the intervention. A population of healthy individuals will be recruited who will carry~     out the same training program, in order to compare the training effects respective to the~     general population.~   "
16217|NCT02845050|"~     Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with~     cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer~     (JaNEO).~   "
16218|NCT02845037|"~     The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single~     oral doses~   "
16238|NCT02844777|"~     This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled,~     multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of~     VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult~     subjects.~   "
16239|NCT02844764|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000~     patients.~   "
16219|NCT02845024|"~     Aim:~      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy~     plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who~     have periodontitis.~      Materials and methods:~      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and~     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and~     type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More~     than 110 have), and also with periodontal disease are chronic moderate (at least in three~     areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by~     clinical examination and radiographic signs are being); Takes place. The initial HbA1c~     Patients should be between 7-9 percent over the past three months has changed his medication~     also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe &~     Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and~     its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded.~     Group 1: (12 patients) was treated with oral hygiene instruction, Scaling, and root~     planing, and doxycycline for 15 days; and Group 2: (12 patients) has the same treatment~     but with placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS),~     glycated hemoglobin (HbA1c) level, will be reevaluated.~   "
16220|NCT02845011|"~     The investigators will conduct a randomized, controlled, single-blinded study of patients~     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of 12 academic teaching~     hospitals in Iran from August 1, 2016 to February 31, 2017. The intervention and control~     groups were labeled group 1 and 2 respectively. The assessment tool was scored by the~     principle investigator and an ICU nurse. The data analyzer was blinded to group~     randomization and was not present during CPR.~   "
16221|NCT02844998|"~     The purpose of this study is to investigate the relationship between physical activity and~     PE, and determine whether moderate physical activity might delay ejaculation time or be an~     alternative treatment for PE.~   "
16222|NCT02844985|"~     The study is intended to identify gene polymorphisms significantly associated with specific~     behavioral- and preoccupation-typologies of sexual addiction, and to identify additional~     potential genetic markers of sexual addiction. Research subjects with sexual addiction will~     be identified from the out-patient and in-patient populations of the investigative sites.~     Research subjects in the Control Group will be identified from the general population and~     from the student body of selected colleges. Approximately 1100 subjects will be enrolled in~     the study. Anticipating 10% drop-out, this is intended to generate a population of~     approximately 500 men and women clinically diagnosed with sexual addiction, and~     approximately 500 healthy men and women who do not meet diagnostic criteria for sexual~     addiction nor have psychopathology who will serve as the control population.~   "
16223|NCT02844972|"~     Decisions to limit and stop active therapeutics are common in the emergency unit. They are~     framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable~     obstinacy and care of the patient's pain in later life. The pain assessment is an issue for~     these patients whose in majority, are not communicating. Moreover, no specific tool and the~     teams in charge, not knowing the patient make the recognition and treatment of pain symptoms~     very complex. This is the potential interest of directly involving the family or the person~     of confidence in this management , the first step being the detection and evaluation of~     pain.~   "
16224|NCT02844959|"~     The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial~     fibrillation recurrency after ablation. Inflammatory response will be assessed by double~     measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix~     metallopeptidase 8 (MMP8) and body temperature. Dynamics of change of troponin I will be~     measured additionally.~      After ablation each patient will be monitored with ECG telemonitoring system for 7 days.~   "
16225|NCT02844946|"~     Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent~     operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing~     persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also~     experience significant distress, including depression and post-traumatic stress disorder, as~     well as persistent pain. Importantly, significant stigma is associated with seeking mental~     health care among Veterans; and poor management of multiple conditions results in increased~     morbidity and mortality, increased risk for suicide, and significantly decreased quality of~     life. Thus the challenge for treatment providers is to provide a unified and acceptable~     intervention for Veterans with these interdependent systemic comorbid concerns. The aim of~     this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to~     more than one diagnosis) life skills workshop to help Veterans develop skills needed to~     pursue valued goals in the face of life's challenges.~   "
16226|NCT02844933|"~     The primary objectives of this study are to assess the efficacy of Cannabidiol Oral Solution~     on hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS), and to assess~     the efficacy of Cannabidiol Oral Solution on body weight in subjects with PWS.~   "
16227|NCT02844920|"~     This study is designed to observe the presence or absence of intrauterine adhesions at 6~     weeks after treatment with the Sonata® System through hysteroscopic evaluation by third~     party readers.~   "
16240|NCT02844751|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000~     patients.~   "
16241|NCT02844738|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000~     patients.~   "
16242|NCT02844725|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic~     drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind,~     parallel, and placebo-controlled study.~   "
16243|NCT02844712|"~     Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by~     mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a~     negatively tested beta-lactam.~   "
16244|NCT02844699|"~     A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy~     study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in~     patients with prostate cancer.~   "
16228|NCT02844907|"~     The purpose of this study is to determine the interaction of GLP-1 and GIP to regulate~     insulin secretion in nondiabetic subjects. The first part of this aim will determine the~     threshold plasma concentration of GLP-1 that increases insulin secretion to test the~     hypothesis that fasting levels of circulating GLP-1 are insufficient to mediate β-cell~     secretion. The second part of the aim will determine whether the insulin response to~     specific amino acids is dependent on the α-cell release of GLP-1.~      The study will enroll up to 40 healthy overweight participants and while it is anticipated~     that the screening blood draw will yield a number of screen failures, it is estimated that~     12 subjects will complete the entire study protocol. Enrolled participants will be asked to~     complete five study visits including the consent visit and four infusion study visits that~     will include hyperglycemic clamps. Each infusion procedure will last 4 hours.~      The primary outcome for visits 2-3 will be insulin secretion in response to hyperglycemia~     and GLP-1. Data will be analyzed using 2-way ANOVA for repeated measures using time and~     treatment as the two factors. Post-hoc comparisons will be used to determine the stage when~     intact GLP-1 levels exceed fasting levels and the stage when insulin secretion exceeds that~     of the clamp alone. The primary outcome for visits 4-5 will be arginine-stimulated insulin~     secretion with and without GLP-1r blockade. The mean increment of ISR above baseline in the~     15 minutes after arginine stimulation will be used to integrate insulin secretion, the~     primary outcome measure, and two-way analysis of variance with fasting/hyperglycemia, and~     Ex-9/saline as the two factors; post-hoc comparisons among the 4 insulin responses will be~     made if a significant interaction is present.~   "
16229|NCT02844894|"~     This study investigates the effects of dexmedetomidine and esmolol given intravenously~     before intubation on sympathetic response caused by intubation itself. Half the patients~     will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia~     modified albumine levels will be measured~   "
16230|NCT02844881|"~     The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients~     with advanced solid tumors.~   "
16231|NCT02844868|"~     Transcortical direct current stimulation (tDCS) is an emerging technique in the~     rehabilitation of hemiplegic patients after stroke.~      This study aims to assess the observance and the tolerance of repeated tDCS stimulation over~     the primary motor cortex of the lower limb coupled to a motor training program, among~     hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind,~     study with two parallel groups of 15 subjects each. The study will analyze first, the~     patient's observance considered good if 75% of the patients completed the entire protocol~     duration and the tolerance through a questionnaire. The secondary end point will try to~     estimate, if possible, the effect size of the walking performance measured with the~     six-minute walk test and aerobic performance measured with VO2peak of this training program~     compared to the same program combine with placebo stimulations. These evaluations are~     performed before, during and after the rehabilitation program.~   "
16232|NCT02844855|"~     Memory for action is especially important in everyday life although current literature is~     not very abundant. The enactment effect (i.e. better memory for performed actions than for~     verbally encoded sentences) is usually described as a robust effect in aging and can be~     found in many diseases. Although the enactment effect has been studied for three decades,~     there is still no consensus on how it enhances memory. Therefore, in order to gain~     additional insight into the representational basis of the enactment effect, in the present~     study, the investigators propose to test neurological patients. The investigators suggested~     that memory for action should be better than memory for verbally encoded information in~     Alzheimer's disease and Parkinson's disease.~      If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive~     assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD~     (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will~     perform the same tests to verify that they have no cognitive impairment. Then, two~     experimental conditions will be presented in all patients and controls: a first in which~     participants will have to name drawings (verbal learning) and a second in which they will~     have to reproduce an action associated with drawings (action learning). Immediately after~     this learning phase, a recognition task will be available and therefore participants will~     have to recognize drawings that had been presented previously. The main criteria used in the~     statistical analysis will be the correct recognition score.~   "
16233|NCT02844842|"~     This is an observational prospective study to assess the tolerability and safety of~     treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will~     be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses~     at initiation period till maintenance dose is reached) The study population is both: adult~     and child, polysensitized to at least 2 allergen sources with rhinitis or allergic~     rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.~      The assignment of a patient to a particular therapeutic strategy will not be decided in~     advanced by a trial protocol but will be determined by routine clinical practice. The~     decision of the investigator to prescribe a particular treatment will be clearly dissociated~     from the decision to include the patient in the study. The patients will not suffer any~     intervention, whether diagnostic or monitoring, other than the usual in clinical practice.~   "
16234|NCT02844829|"~     This study will enroll 200 men with clinical suspicion of prostate cancer due to higher~     serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.~      Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla~     (T) magnetic field using surface coils will be used to non-invasively predict the presence~     or absence of prostate cancer.~      Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine~     twelve core TRUS biopsy.~      Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh~     biopsy sample will be collected and correlated with the presence or absence of prostate~     cancer.~   "
16235|NCT02844816|"~     This phase II trial studies how well atezolizumab works in treating patients with non-muscle~     invasive bladder cancer that has come back and has not responded to treatment with Bacillus~     Calmette-Guerin (BCG). Monoclonal antibodies, such as atezolizumab, may block specific~     proteins found on white blood cells which may strengthen the immune system and control tumor~     growth.~   "
16236|NCT02844803|"~     The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis~     Combination Therapy in Type 2 Diabetes Mellitus Patients.~   "
16249|NCT02844634|"~     Men who have sex with men remain at high risk for HIV infection. Targeting prevention~     interventions to MSM at highest risk of seroconversion is an important goal of combination~     prevention interventions. Antecedent diagnosis of another sexually transmitted infection~     (STI), particularly syphilis, may serve as an entry point for biomedical prevention as these~     individuals are at highest risk for incident HIV. The use of the antiretroviral combination~     of tenofovir/emtricitabine has been shown to be associated with an overall 44% reduction in~     HIV acquisition in high-risk MSM when taken daily as PrEP. In those individuals with~     detectable drug levels, the benefit was as high as 90% risk reduction. In real-world~     evaluations of PrEP, high-risk sexual behaviour may continue as evidenced by high rates of~     intercurrent sexually transmitted infections. As such, biomedical interventions that may~     offer additional reduction in acquisition of common sexually transmitted infections should~     also be evaluated.~      Recently a small pilot study has demonstrated potential benefit from a similar strategy for~     syphilis prevention. In this study 30 MSM were randomized to receive either 100mg~     doxycycline once daily or contingency management strategies linked to remaining free of~     sexually transmitted diseases at progressive study visits. Overall, those receiving~     doxycycline were significantly less likely to be diagnosed with any STI during followup than~     those in the comparator arm.~      The investigators therefore propose to undertake a pilot study to evaluate the feasibility~     of using both tenofovir/emtricitabine and doxycycline (immediate or deferred use) for~     pre-exposure prophylaxis amongst HIV-negative MSM with recent history of syphilis infection~     in Vancouver, Canada.~   "
16250|NCT02844621|"~     The purpose of this study is to evaluate the effects of a common over-the-counter~     medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy~     older adults.~   "
16251|NCT02844608|"~     Symptoms related to the disease and/or treatment are common in cancer patients and can~     affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be~     underestimated and underreported by the physician. Measure of the HRQoL has been~     significantly developed in clinical trials and has become a key endpoint to assess clinical~     benefit of new therapeutic strategies and as prognostic factor of overall survival for~     several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer,~     prostate cancer and hepatocellular carcinoma.~      Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for~     advanced solid tumors showed that clinical benefits were associated with symptom~     self-reporting during cancer care, including the improvement of the overall survival.~      The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in~     daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make~     the HRQoL data accessible and exploitable in real time to physician, to help medical~     professionals to optimize their practices by adopting a holistic and personalized approach~     based on the perception of the patients of their HRQoL and symptoms.~   "
16252|NCT02844595|"~     The number of people who smoke, have concurrent depression and that seek treatment for~     smoking cessation has increased in recent years. This implies the need to design intensive~     and specific interventions that target this issue. In depression treatment, behavioural~     activation is one of the psychological interventions whose characteristics of brevity,~     flexibility and efficiency make it an ideal candidate to be included as part of smoking~     cessation treatment, especially when smokers have depressive symptoms. The aims of the~     present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking~     cessation treatment with elements from behavioural activation for managing depressed mood (a~     randomized control trial with three groups: standard cognitive-behavioural smoking cessation~     treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural~     activation, and a control group of delayed treatment) at the end of treatment, and at 3-,~     6-, and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural~     smoking cessation treatment plus behavioural activation improves depressed mood at the end~     of treatment and 3-, 6, 12-months follow-ups.~   "
16253|NCT02844582|"~     This phase II trial studies how well cabazitaxel and prednisone work in treating patients~     with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs~     used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading.~   "
16254|NCT02844569|"~     This study will be a randomized clinical trial involving a total of 24 subjects. The~     investigators propose to recruit subjects into 2 groups: 1) Extraction treated with~     xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction~     treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft~     Seal®). All subjects recruited will have already been approved and treatment planned for~     extraction + implant placement by non-study personnel to avoid any potential conflict of~     interest. All subjects will have radiographs that show the tooth planned for extraction.~     Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation.~     After tooth extraction, subjects will receive a standard site preservation therapy consisted~     with xenograft bone substitute + collagen dressing or the alternative site preservation~     therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the~     conventional 6-month healing period, subjects will receive a dental implant in the previous~     extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm~     gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for~     future histological and histochemical analysis. After dental implant placement, all subjects~     will receive a healing abutment for soft tissue healing prior to implant restoration.~      During the 6-month healing time after tooth extraction and site preservation therapy,~     subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning~     for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed~     tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and~     appropriate extraction planning and at 6-month post-extraction for volumetric measurement~     and appropriate implant treatment planning.~      Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs.~     6-month healing). CBCT images will be analyzed by non-contact reverse engineering system.~     Soft tissue volumetric analysis will be performed to compare the soft tissue healing between~     BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured~     with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.~   "
16255|NCT02844556|"~     The purpose of this study is to carry out an international multicenter trial to get more~     convincing and valuable results of the SMILE surgery and compare the outcomes between the~     SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis)~     surgery.~      The investigators hope to investigate the differences between the SMILE and the FS-LASIK~     surgery comprehensively, including the comparison of visual acuity, refraction, the~     correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the~     corneal ectasia, the characteristics of the changes of central corneal thickness and the~     complications. To meet the demands of a multi center trial, all the examination equipments~     should be same in each center, and this will limit the variations within a study~   "
16256|NCT02844543|"~     This study will assess the effects of exercise and non-concussive bodily contact on~     eye-tracking scores collected by the EYE-SYNC eye-tracking device.~   "
16257|NCT02844530|"~     The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan~     for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370~     MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for~     the expression of CD22 has been chosen in order to propose this protocol to all adults with~     CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is~     almost 100% in this setting but some patients are documented between 70 and 100%. RIT will~     be assessed in comparison with standard of care salvage chemotherapy regimens. Only three~     standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for~     the comparative analysis of clinical efficacy.~   "
16258|NCT02844517|"~     The objective of the study is for clinical staff to gain experience using the proposed~     artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home~     usability prior to initiating a large randomized controlled trial.~   "
16259|NCT02844504|"~     Breast cancer patients often suffer from long-term physical symptoms of weakness. In this~     study, investigators propose to compare how two different low intensity physical exercise~     training programs can improve handgrip strength for breast cancer patients with symptoms of~     weakness. Using brain imaging, the study will also investigate changes in brain structure,~     and muscle activity associated with handgrip.~   "
16260|NCT02844491|"~     Cancer-specific splice variants gain significant interest as they generate neo-antigens,~     that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature~     B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of~     membrane expression of the spliced isoform.~      The investigators group would now determine if it's possible, in patients with~     lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20~     peptides.~      If this memory response exists, it will confirm the interest of this antigen as a target for~     tumor immunotherapy.~   "
16261|NCT02844478|"~     The purpose of this study is to explore the differences in quality of life , inflammation,~     stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers~     of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will~     complete the Stress-Busting Program for Family Caregivers in the language of their choice~     (English or Spanish).~   "
16262|NCT02844465|"~     The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser~     ablation system for mesial temporal epilepsy (MTLE).~   "
16263|NCT02844452|"~     Introduction: Atopic dermatitis (AD) is chronic relapsing inflammatory skin disease inducing~     poor quality of life. Its conventional treatments often cause unsatisfactory relief and~     adverse effect in long-term application. Acupuncture treatment is regarded to have curative~     effect on AD symptoms. The aim of this trial is to evaluate the therapeutic effect of~     acupuncture on AD symptoms including pruritus and poor quality of life in patients with AD.~      Method and Analysis: This trial is randomized, sham-controlled pilot trial with different~     visit frequency. 30 eligible patients with atopic dermatitis will be randomly allocated in a~     ratio of 1:1:1 to the Verum Acupuncture group 1 (VA1, 3 days weekly), Verum Acupuncture~     group 2 (VA2, 2 days weekly) and Sham Acupuncture group (2 days weekly). The acupuncture~     treatment will be given three or two times a week for 4 weeks according to the allocated~     group. The main outcome measures are Visual analogue scale for itch (itch VAS), SCORing~     Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) to evaluate the~     improvement of AD symptoms and Patient Oriented Eczema Measure (POEM), Dermatology Life~     Quality Index (DLQI) to assess the quality of life of AD patients. It will be measured at~     baseline, once a week during treatment period and after follow-up period.~      Ethics/Dissemination: This protocol was approved by the Institutional Review Boards at Kyung~     Hee University Korean Medicine Hospital on May 2016. The permission number is~     KOMCIRB-160212-HRBR-004. This trial will provide the data of therapeutic effects of treating~     atopic dermatitis with acupuncture in accordance with the different visit frequency. The~     outcomes will be facilitated to calculate the sample size of further study with the same~     design of this study. The findings from this trial will be published and presented in~     conference.~   "
16264|NCT02844439|"~     This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with~     recurrent glioblastoma.~   "
16265|NCT02844426|"~     To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria,~     Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.~   "
16266|NCT02844413|"~     Regular exercise is recommended as an adjuvant treatment in hypertensive subjects by both~     European and American guidelines. Crucially, however, there are no precise recommendations~     on the type of physical exercise and how it should be instituted A relatively short period~     (5 months) of regular aerobic interval training (AIT), significantly decreased blood~     pressure, pulse wave velocity, and most applanation tonometry indexes in hypertensive~     subjects also undertaking pharmacological treatment in our study.~   "
16267|NCT02844400|"~     The primary objective of this study is to establish the feasibility and value of physical~     fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this~     project will establish the groundwork for physical function assessment in larger cancer~     clinical trials to assist patient selection and evaluation of toxicity and/or response among~     trial participants.~   "
16268|NCT02844387|"~     This study evaluates the nutritional supplement arginine as supportive measure for patients~     with unresectable metastatic brain tumors that receive radiation therapy with palliative~     intent~   "
16269|NCT02844374|"~     Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of~     the world's population.~      Although effective, epilepsy surgery fails in many cases, the percentage of patients free~     from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of~     epilepsy.~      It is in this context that EPISTIM is interesting, and its aims isb a better~     electrophysiology delimiting of cortical networks that imply the genesis of seizures with~     the aim to improove surgery results.~      This study will rely on the intracerebral records and on corticales electrical stimulation~     as they are currently routinely used by epileptic patients candidates for surgery.~   "
16270|NCT02844361|"~     The purpose of this study is to evaluate whether autologous stem cell transplantation will~     improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with~     conventional chemotherapy.~   "
16330|NCT02843568|"~     The purpose of this study is to develop radiation plans that will help preserve lung~     function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful~     in designing radiation treatment plans that help us avoid healthy normal functioning lung~     tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly~     where the tumor is and how it moves when you breathe. In this study we will also use the~     4DCT scans to try to identify high functioning normal lung tissue.~   "
16271|NCT02844348|"~     A chronic renal disease can results in the development of cardiovascular complications,~     including chronic arterial disease ; but a cardiovascular disease may be from a kidney~     malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic~     hemodialysis patients taken in charge in Grenoble in the last years suffered from an~     arterial disease at a symptomatic stage. Breakthrough pain can appear during the~     hemodialysis sessions. These sessions induce sudden hemodynamic changes and a peripheral~     vasoconstriction reaction that increases in particular all pain phenomena related to chronic~     low limbs ischemia. Therefore, patients have to face pain, sometimes chronic but also~     breakthrough pain, during the dialysis sessions, in all its dimensions.~      The analgesic balance through the classical drug treatment is extremely complex, as they are~     both at risk of overdose and of partial effectiveness. Strict medical treatment remains~     unsatisfactory, as it takes into account only the expressions of symptoms during dialysis~     sessions, when most of the time pain is already installed and analgesic treatment is not~     completely effective.~      The combination of classic pharmacological treatment with hypnosis, already used in other~     indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful~     feeling on patients suffering from arterial disease during the dialysis sessions, with a~     beneficial impact on their overall quality of life. There is also evidence to suggest that~     hypnosis may be more effective treating neuropathic or vascular pain, those experienced by~     our patients, than musculoskeletal pain, like back pain.~      Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act~     of dialysis. It can be described at the same time as a modified state of consciousness and a~     particular intersubjective relation between a practitioner and his patient. The practice of~     this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the~     trust developed during regular chronic treatment can become an asset to shorten the~     induction phase and help to install this intersubjective relation.~      The high incidence of this complication, the difficulties of current pain management and the~     impact on everyday life for the patients, justify the choice of this approach, where more~     further research is needed.~   "
16272|NCT02844335|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced breast cancer.~   "
16273|NCT02844322|"~     The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone~     combined with rituximab or bortezomib regimens in newly diagnosed Waldenström~     macroglobulinemia patients.~   "
16274|NCT02844309|"~     The purpose of this study is to evaluate the efficiency of an oral regimen in newly~     diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone~     following by thalidomide and prednisone maintenance therapy.~   "
16275|NCT02844296|"~     Smoking is highly addictive and quitting is difficult. Relapse is common because of~     withdrawal symptoms such as craving, headache, mood change and irritation. In addition to~     pharmacotherapy, exercise can acutely reduce craving, withdrawal symptoms and negative~     affect in regular smokers. Exercise effectively reduces negative affect and attentional bias~     towards smoking, and hence might relieve craving.Instead of long duration (30+ minutes)~     exercise, short-bout exercise is more easily adhered to in daily living and achieves similar~     health gain as long-bout exercise.Handgrip, which enhances training of hand-griping~     strength, is a common short-bout exercise tool used for lowering blood and arterial~     pressure.Therefore, this exercise tool might also raise smokers' interest to initiate this~     simple and effective exercise for quit attempt.~      This RCT study was proposed by using short-bout exercise (intervention) and healthy diet~     (control ) for smoking cessation, targeting adult clients who enrolled in smoking cessation~     service of ICSC, smoke 10 cigarettes or more a day when they initially receive the treatment~     from ICSC, can access to Internet by using smart phone and interested in participating in an~     exercise/diet program for smoking cessation. All the participants will be randomized the~     subjects to one of the RCT groups by using sequentially numbered, opaque sealed envelope~     method. Participants from both groups will be helped to install a phone application (App) in~     their smartphone which can send reminders of doing exercise or healthy diet. Also, the~     participants will enter their smoking and craving data by the App by answering the automatic~     pooped daily questionnaire. Telephone follow-up will be conducted at 2,6 and 12 months.~   "
16276|NCT02844283|"~     This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial~     infarction disease.~   "
16277|NCT02844270|"~     The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a~     total of 45 patients. The goal is to access the feasibility, safety and efficacy of~     Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with~     de novo coronary lesion.~   "
16278|NCT02844257|"~     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an~     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,~     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive~     induction plus more potent intensification programs with chemotherapy alone or chemotherapy~     plus stem cell transplantation (SCT) has improved treatment results. Advances in~     understanding disease biology, improvements in induction and consolidation program, and~     better supportive care have also all contributed. A number of clinical and laboratory~     characteristics influence the response to treatment and, thus, the survival of patients with~     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.~     However, other factors may have a prognostic value and may influence patient's outcome.~      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it~     has become apparent that the frequency of allogeneic blood transfusions can modify host~     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic~     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood~     cell (RBC) transfusion need was identified as a strong and independent risk factor for~     survival in MDS, for which the presence and severity of anaemia were attributed to a~     clonally advanced and biologically more aggressive disease.~      Based on these data, the investigators retrospectively assessed the prognostic value of RBC~     and platelet transfusions at the time of diagnosis and the frequency of transfusions during~     the first induction course of chemotherapy in a large unselected group of patients with~     previously untreated AML.~   "
16279|NCT02844244|"~     To strengthen family well-being and neighborhood cohesion in Kwun Tong community, a~     community -based Learning families campaign was conducted. As an initial step of this~     project, the investigators conducted a need assessments before designing and conducting a~     train-the-trainer workshop.The train-the-trainer workshop aimed to prepare the members of~     Estate Management Advisory Committees (EMAC) and Mutual Aid Committees (MACs) to implement~     and assist in conducting a series of community-based family well-being activities for~     residents in a public housing estate. Focus group interviews (before and one year after~     training workshop) were conducted to obtain opinion from the members of EMAC and MACs of the~     public housing estate. Questionnaire assessments were conducted before, immediately after~     finishing the training workshop, one year after training workshop.~   "
16331|NCT02843555|"~     The purpose of this study is to:~        1. define novel homogeneous groups of patients with LDs and~        2. work toward finding the cause of these disorders.~   "
16280|NCT02844231|"~     Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This~     NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during~     arousal from SWS, that induce psychological distress and alter quality of life, leading to~     fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning.~      The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty~     maintaining stable, consolidated sleep and experienced more arousals and microarousals,~     specifically from SWS, leading to increased NREM instability, especially during the first~     sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and~     partially in NREM sleep, resulting in no conscious awareness of actions.~      A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode~     found increased activation in the posterior cingulate cortex and cerebellum, with~     deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during~     confusional arousals confirmed both local arousal of the motor and cingulate cortices and~     increased delta activity in the frontoparietal associative cortices.~      The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12~     SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and~     12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep~     deprivation condition associated with forced arousal (auditory stimulus).~      The comparative analyses of SPECT acquisitions between different states (wakefulness, slow~     wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights~     about the complex pathophysiology of SW episodes.~   "
16281|NCT02844218|"~     Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those~     aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly~     patients, owing to comorbidities, the greater possibility of other hematopoietic disorders,~     and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy,~     administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy~     for this patient population. This approach improved survival compared with supportive care~     (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that~     the results of intensive chemotherapy in elderly patients remain poor. Although complete~     remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term~     survival has been poor. Furthermore, most clinical trials have only enrolled patients with~     an adequate performance status (PS).~      Prognostic models have been developed from clinical trial data to predict the outcomes for~     older patients. However; each model relies on chronologic age. Age is a surrogate measure~     for both changes in tumor biology and patient characteristics. Understanding which patients~     are likely to benefit from intensive therapies versus low-intensity therapies or supportive~     care is critical. The definition of fit to undergo intensive induction therapy has not~     been established, and the therapeutic choice is mainly determined by physician and patient~     decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more~     beneficial than best supportive care and hydroxyurea. The recent availability of new drugs~     that could have an improved side effect profile and, in some cases, bioavailability might~     offer future improvement for this patient population. In this setting, the investigators~     have tended to consider, since 2007, patients aged ≥70 years as potential candidates for~     alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they~     presented in good physical condition.~      The investigators goal was to determine whether age ≥ 70 years could represent a useful and~     simple cut off for treatment decision-making in clinical practice and whether low-intensity~     therapy could be an alternative therapeutic approach to intensive chemotherapy even for~     patients aged ≥ 70 years who were theoretically fit (WHO /ECOG/ PS of ≤ 2).~   "
16282|NCT02844205|"~     Neonatal intensive care is necessary for the survival of preterm baby. Several studies show~     the deleterious effect on the immature brain due to stimulations caused by the environment~     and hospital care.~      However, a specific and individualized support to the development during the first weeks of~     this preterm patient has a positive effect on newborn development.~      A new practical newborn behavioral observation scale has been developed by the investigators~     care unit in order to adapt care and individualized support to the development for each~     patient.~      The goal of this study is to estimate the external reproductibility of this scale by~     experimented nurse in order to implement an individualized care program.~   "
16283|NCT02844192|"~     Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of~     treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution,~     vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin~     underdosing in ICU patients, among others.~      To date, bedside estimation of vancomycin volume of distribution is challenging, and new~     methods for optimizing drug administration are required.~      The Picco device is a moderately invasive hemodynamic monitoring system, providing~     parameters that may help estimation of vancomycin pharmacokinetics parameter.~      The aim of this study is to test whether addition of hemodynamic parameters would improve~     pharmacokinetics modelling of vancomycin concentration in ICU patients.~   "
16284|NCT02844179|"~     This research study is intended to determine the initial safety and tolerability of single~     oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is~     believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name~     Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's~     chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized~     (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ,~     the drug to be studied in this research, is the active ingredient in TBZ. The present study~     will confirm safety and tolerability of HTBZ and will investigate its expected effects on~     brain sites that are the target of TBZ therapy.~   "
16293|NCT02844062|"~     Chimeric antigen receptor (CAR)-modified T cells can mediate long-term durable remissions in~     recurrent or refractory CD19+ B cell malignancies, and are a promising therapy to treat~     glioblastoma, which is the most dangerous and aggressive form of brain cancer. EGFRvIII~     mutation (epidermal growth factor receptor variant III, EGFRvIII) is the results of tumor~     specific gene rearrangement naturally happened in about 30% of glioblastoma patients and~     produces a mutated protein with neo-antigen that is tumor specific and is not expressed in~     normal human tissues. Therefore, EGFRvIII is an attractive target for CAR T cell therapy. We~     have constructed a lentiviral vector that contains a chimeric antigen receptor that~     recognizes the EGFRvIII tumor antigen. A truncated EGFR (tEGFR) which lacks of the ligand~     binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CAR~     vector and is used for in vivo tracking and ablation of CAR T cells in necessary. This pilot~     study is to determine the safety and efficacy of autologous anti-EGFRvIII CAR T cells in~     patients with recurrent glioblastoma.~   "
16332|NCT02843542|"~     A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr)~     prior to surgery in parathyroid tumor patients.~   "
17037|NCT02834338|"~     Randomized Controlled Trial to monitor and increase the postoperative mobilization of the~     patients undergoing major visceral surgery by giving a continuous autofeedback of the step~     count using activity tracking wristbands.~   "
16285|NCT02844166|"~     The presence of pressure injuries has been considered a quality indicator of health care~     services and efforts has been made to develop guidelines to prevent this issue. Intensive~     care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due~     to reduced mobility of critically ill patients and large number of devices and hard~     technologies that jeopardize preventive measures, such as, decubitus changes. There are not~     current definitive evidence about the superiority of any support surface to treat or prevent~     pressure injuries. The objective of the present study is to analyze if the use of~     viscoelastic support surface in vulnerable critically ill patients decreases the incidence~     of pressure injury compared with pyramidal foam support surface.~      Randomized clinical trial performed in an intensive care unit for adult patients in a~     philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤~     14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay,~     contraindication of performing complete institutional preventive measures for support~     injuries, presence of support injuries at ICU admission or absence of informed consent.~     Randomization will be made by computerized generated numbers and patients will be allocated~     in two groups in a ratio of 1:1. All study patients will be cared for according to standard~     institutional preventive measures. The interventional group will be placed in an ICU bed~     with viscoelastic support surface and the control group in an ICU bed with pyramidal foam~     support surface. The main outcome evaluated will be the occurrence of type II pressure~     injury. Secondary outcomes are the time to the occurrence of pressure injury, length of ICU~     and hospital stay and 28 days mortality rate. Significance level will be 5%.~   "
16286|NCT02844153|"~     Metformin is the most widely prescribed oral treatment for diabetes, and the only one that~     showed a survival benefit.~      Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney~     disease (CKD) patients.~      The aim of the study is to describe the use and side-effects of metformin in CKD patients in~     routine practice.~   "
16287|NCT02844140|"~     Dose distribution calculations for proton therapy are more accurate when based on DE-CT than~     on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations~     is for lung cancer patients.~   "
16288|NCT02844127|"~     The purpose of this study is to determine how the position of the right ventricular (RV)~     coil of an implantable cardioverter defibrillator (apex versus septum) affects the~     defibrillation threshold; specifically, can defibrillator threshold be improved by~     implantation site selection.~   "
16289|NCT02844114|"~     This study evaluates the effect of the serum level of Superoxide Dismutase (SOD),~     Malondialdehyde (MDA), pro-inflammatory factors, stress hormones and Glutathione peroxidase~     (GSH-PX)in tumor patients with the treatment of Ganoderma lucidum spore based combination~     chemotherapy. Half of participants will receive Ganoderma lucidum spore and chemotherapy in~     combination, and the other half will receive a placebo and chemotherapy.~      Study design: Phase 2. Experimental: Ganoderma lucidum spore & Chemotherapy; Placebo~     Comparator: Placebo & Chemotherapy.~      Outcome Measure:~        1. The life quality of participants was assessed with use of the Functional Assessment of~          Cancer Therapy-General (FACT-G) questionnaire at the initial diagnosis (baseline) and~          at 42 days after the treatment;~        2. Investigators assessed Procedural mortality factor ligand 1(PD-L1)expression~          prospectively on tumour cells and tumour-infiltrating immune cells with the VENTANA~          PD-L1 immunohistochemistry assay;~        3. National Cancer Institute Common Toxicity Criteria.~      Statistical analysis: All experiment results were analyzed with Statistical Product and~     Service Solutions (SPSS) software (version 16.0). Data are presented as mean±standard~     deviation and analysed by one-way ANOVA. Semi-quantitative data were compared using the~     Kruskal- Wallis nonparametric analysis. The results were considered statistically~     significant at P<0.05.~   "
16290|NCT02844101|"~     Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded~     and the non-blinded group. The blinded subjects will be informed that we were testing the~     reliability of a new device for body posture assessment and these youngsters will did not~     receive any information with regards to physical activity. Conversely, the non-blinded~     subjects were informed that the device was an accelerometer that assessed physical activity~     levels and patterns. Participants will be instructed to wear the accelerometer for 4~     consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall~     duration and the duration relative to the quality of the physical activity patterns~     (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group~     during the 4-day monitoring, then compared between the two groups using the Student's t~     test.~   "
16291|NCT02844088|"~     Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in~     Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European~     countries, France introduced meningococcus C conjugate vaccine in 2009 but this~     recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in~     2015).~      The situation in France is very different from UK and there is no data on the subject. The~     vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison~     between vaccinated and unvaccinated people, among which meningococcus circulation could~     maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and~     natural immunity among Puy-de-Dôme population.~   "
16292|NCT02844075|"~     In this study, participants with esophageal squamous cell carcinoma will receive~     preoperative chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo~     surgery. The primary study hypothesis is that adding pembrolizumab will increase complete~     pathologic response rate at surgery.~   "
16305|NCT02843906|"~     The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's~     Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of~     cognitive deficits in older patients with bipolar disorders.~   "
16333|NCT02843529|"~     The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool~     to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.~     The design of this study is guided by two overriding factors: 1) to optimize the performance~     of the ALTOIDA™ neuromotor classifiers, the subjects making up the training sets must be~     well characterized as to their clinical diagnosis, and 2) all ALTOIDA™ tests must be~     performed and reproduced in real-world clinical settings.~   "
16294|NCT02844049|"~     Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as~     more than 40% of patients are resistant to the standard pharmacological and psychotherapy~     approaches and about 10% show severe disability and require institutionalization. These~     resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain~     Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate~     neural networks. Although promising, these results need nevertheless to be replicated and~     confirmed within a larger cohort of patients and considering a different main objective,~     instead of clinical improvement only. Indeed, despite a positive treatment response,~     adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus~     beyond symptom reduction, health-related quality of life (QoL) represents a more important~     objective of a treatment, as it includes both the individual's functional status and the~     individual's subjective perception of the impact of the illness on the patient's life. STN~     DBS induces significant clinical improvement, which may not be proportional to the QoL gain.~     Consequently, QoL appears to be a better outcome to target in the coming studies than~     clinical improvement alone. THe investigators thus propose a prospective study assessing the~     QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT)~     at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus~     BMT alone.~   "
16295|NCT02844036|"~     Currently, the standard treatment for proximal thromboses lesions responsible for~     post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages~     are judged too distal or the patient is judged inoperable for a curative surgical gesture,~     there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent~     embolism. Prognosis is then pejorative with a 60% mortality at 5 years.~      This study propose an alternative treatment for these patients in therapeutic dead end.~     This is about applying arterial thrombosis technique to the pulmonary circulation.~   "
16296|NCT02844023|"~     Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is~     the most frequent vasculitis of the population over the age of 50. This vasculitis is at the~     origin of an inflammatory infiltrate of arterial tunics, essentially composed of~     lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw~     pain, scalp hyperesthesia, but can also be serious ischemic complication, especially~     ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high~     dosage corticosteroid therapy.~      Diagnosis is based on criterias of the American College of Rheumatology, dating back to~     1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are~     also issues of becoming dependent on steroid.~      So it is important to determine new diagnosis markers and a therapeutic following of giant~     cells arteritis.~      With this study several biomarkers of inflammation will be studied in order to determine if~     one ore many of them have a good sensitivity and special feature for diagnosis and following~     of giant cells arteritis.~      The main goal is to determine a new diagnosis marker for giant cells arteritis.~   "
16297|NCT02844010|"~     This study is based on the change in weight of hospitalized patients knowing that the~     diagnosis of malnutrition based on the presence of at least one clinical or laboratory test~     which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in~     hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in~     cases of wasting energy and protein in the elderly April 2007).~      The goal of this study is to find the correlation between hospitalization and weight loss,~     significant risk factors for malnutrition in a situation of community-acquired pneumonia~     infection.~   "
16298|NCT02843997|"~     Bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and~     socio-professional life of sick subjects, and also increase mortality by suicide. Suicide is~     considered as a bipolar disorder result.~      The main goal of this study is the endophenotype characterization from a clinical and~     cognitive point of view, of a bipolar spectrum's disorder present in a family, and then~     highlight a mutation of one of the genes involved is this disorder.~   "
16299|NCT02843984|"~     Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid~     concentration of 47 cytokines, chemokines and growth factors.~   "
16300|NCT02843971|"~     Monocentric, prospective study, comparison of the water drinking test response in the supine~     and in the sitting position using the intraocular pressure monitoring device Sensimed~     Triggerfish in healthy subjects.~   "
16301|NCT02843958|"~     This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of~     blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).~      This device was created as an alternative to blood sample, that have to be done in a medical~     laboratory.~      The main goal is to evaluate the accuracy of the International Normalized Ratio (INR)~     measurement of this new portable device for diagnostic in vitro, among healthy patients and~     patients under anti-vitamin K treatment.~   "
16302|NCT02843945|"~     Initial study to evaluate local control and the preferred method of attachment of the~     CivaSheet in the setting of suspected close or positive margins at the time of surgical~     tumor removal.~   "
16303|NCT02843932|"~     The aim of this study is to reveal neurobiological bases of the motor control of conscious~     perception, thanks to new techniques of functional cerebral imaging (MRI), and potentials~     deteriorations connected to neuropsychiatric disorders like conversion disorder.~      The Hospital University Center of Grenoble will provide patients from Neurology department,~     characterized with non psychogenic epileptic seizures and abnormal psychogenic movements,~     from conversive origin.~      Subjects will be scanned by Magnetic Resonance Imaging during a motor paradigm inducing a~     perceptive conflict between two informations : proprioceptive information coming from the~     action (drawing) and visual information (draw's mark) that appears on the screen when there~     is movement.~   "
16304|NCT02843919|"~     The goal is to identify neuro-physiological signatures at several levels of mental workload~     during the realisation of tasks, performed by all the subjects.~      In parallel, there will be a methodological work consisting to develop the classification~     algorithms, predictives of these levels of mental workload in real time, in purpose to~     implement a passive brain-machine interface in the best interest of operators that~     accomplish complex tasks.~      Mesures of electro-physiological activity will be recorded in order to approve states of~     charge in addition to behavioral performances.~   "
16306|NCT02843893|"~     Sedation-analgesia is an important therapy for patients in resuscitation. It requires a~     surveillance, in order to avoid excessive or insufficient dosages of sedative or~     nonmorphinics, sources of side effects. Yet, means of surveillance are limited in~     resuscitation care : variations of blood pressure and heart rate are not very sensitive~     criterias. Clinical scales to measure the sedation and analgesia level were proposed for~     patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural~     pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive~     stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients~     under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold~     by pupillometry for patients in resuscitation receiving a sedation-analgesia.~      The main goal of this study is to measure the minimum intensity of a painful stimulation~     (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care~     receiving sedation-analgesia continuously.~   "
16307|NCT02843880|"~     Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to~     80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any~     pathological consequence. Immunosuppression may reactivate the virus causing either a~     CMV-active infection or a CMV disease with attributable symptoms.~      In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical~     immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim~     is to study the risk factors for developing viremia or CMV disease in ICU patients in septic~     shock without previous immunodepression and determine the relationship between viral~     reactivation and this acquired immunity alteration.~   "
16308|NCT02843867|"~     The incidence of atherosclerotic complications is increased after kidney transplantation.~     Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an~     inflammatory disease in which all players in the immune response are involved. The impact of~     these immune responses is not well known in immunocompromised patients, particularly among~     organ transplant. Nevertheless, the work of our group suggest that innate and acquired~     responses through different mechanisms influencing the evolution of atheromatous disease~     after transplantation.~      The investigators therefore propose to study the impact of the expansion of regulatory T~     cells on the risk of atherosclerotic complications after transplantation.~      Since November 2008, the investigators began a multicenter, prospective study whose purpose~     is to study in detail the immunological mechanisms of atherosclerosis after transplantation~     via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It~     was planned to include 500 patients and to date a little more than half have been included.~     After completion of the blood test, the tubes are routed over the Biomonitoring Platform~     (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.~      The atherosclerotic events are recorded prospectively. The investigators hope to implement~     as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T~     cells on the risk of atherosclerotic events.~      Our hypothesis is that a cell rate regulatory T below the median results in an increase of~     5% of atherosclerotic complications.~   "
16309|NCT02843841|"~     The prevention of allograft rejection in kidney transplantation requires administering to~     the patient an immunosuppressive regimen of induction. The induction strategy is based on an~     injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a~     lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic~     the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk~     patients. Our group showed a significant increase in death rates in transplant patients with~     lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is~     related to complications following chronic inflammation observed in some patients~     lymphopenic.~      Preliminary studies have shown that the induced lymphodéplétion ATG appears to be~     accompanied by an increase of the bacterial products in the blood of transplanted since a~     significant increase in the sCD14 is observed in these patients one year. We also observed~     increased concentrations of LPS in patients in the ATG group. This could indicate a~     secondary bacterial intestinal translocation to a weakening of intestinal immunity linked to~     the ATG.~      The main objective of the study is to assess the impact of anti-lymphocyte globulin~     polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a~     constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.~      The secondary objectives are to evaluate bacterial translocation, the effect of bacterial~     translocation on structural and metabolic functions of the intestinal epithelium, chronic~     inflammation, immune reconstitution, regeneration, activation and proliferation of T~     lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate~     immunity and the composition of the intestinal microbiota.~      The study population consists of renal transplant patients of Nephrology of the University~     Hospital of Besancon. Patients will be divided into 2 groups according to induction~     immunosuppressive therapy prescribed the day of renal transplantation as part of their usual~     care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody~     treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with~     anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the~     group of patients treated with ATG.~   "
16310|NCT02843828|"~     The purpose of this study was to investigate the effects of the new wearable hip assist~     robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd.,~     Korea) to gait rehabilitation in elderly adults and stroke patients.~   "
16311|NCT02843815|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced NSCLC.~   "
16312|NCT02843802|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced liver cancer.~   "
16313|NCT02843789|"~     The aim of this study is to analyze the variation of adiponectinemia and its molecular forms~     in RA patients receiving tocilizumab therapy.~   "
16314|NCT02843776|"~     The study epiDESA2 identifies all explicit requests for euthanasia or assisted suicide~     expressed by the person him/herself, regardless of which professional is asked and~     regardless of where the request is made (primary care, health institutions, medico-social~     institutions including nursing home care or at home) in the Burgundy-Franche-Comté region~     during six months.~   "
16325|NCT02843633|"~     This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the~     Gazelle™ Bare Metal Stent arm of the Leaders Free study in high bleeding risk patients.~   "
16326|NCT02843620|"~     This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native~     type-II collagen, on adults with moderate knee pain. Half of the participants will receive~     the b-2Cool containing supplement while the other half will receive a placebo pill.~   "
16327|NCT02843607|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced kidney cancer.~   "
16328|NCT02843594|"~     The purpose of this research study is to evaluate the clinical outcomes of different~     cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract~     surgery.~   "
16329|NCT02843581|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced esophageal cancer.~   "
16315|NCT02843763|"~     As early complications of transplantation (acute rejection and infections) were better~     controlled and that the survival of kidney transplants has increased, chronic complications~     of immunosuppression became increasing challenges. The incidence of cancer is greatly~     increased in transplant and cancer is now the first cause of death. The iatrogenic~     immunosuppression plays a major role in the increased incidence of cancer. If it is accepted~     that the incidence of cancer is generally increased after transplantation, the increased~     risk is very different from a specific cancer to another. Furthermore the specific treatment~     of the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the~     context of transplantation is related to the possibility of modulation of immunosuppression.~     However, there is no immunological marker for predicting the effectiveness of a modification~     of the immunosuppression.~      Several studies point to the important role of CD4 T cells into Th1 anti-tumor~     immunosurveillance group cancers. Identified helper degenerate peptides, called Universal~     Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP~     peptides bind most HLA-DR alleles most frequent of the population and have the particularity~     of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it~     possible to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of~     human cancers.~      The main objective of this study is to determine whether, in renal transplant patients, the~     occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.~   "
16316|NCT02843750|"~     To obtain definitive evidence for the effectiveness of a short preoperative inspiratory~     muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical~     resection.~   "
16317|NCT02843737|"~     The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep~     fragmentation on 405 patients who will perform a polysomnography under spontaneous~     breathing.~   "
16318|NCT02843724|"~     A two year, two arm pragmatic trial to investigate the integration of naturopathic care with~     conventional medical care to provide additional benefit beyond that of conventional medical~     care alone in achieving adequate control of diabetes.~   "
16319|NCT02843711|"~     LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery~     during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung~     adenocarcinomas. For all patients, clinical data and histopathological data are available.~     The objective of this study is to characterize these lung adenocarcinomas by the LungCarta~     Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA~     mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study,~     the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform~     immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are~     correlated with clinical, histopathological and molecular data.~      Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's~     expression.~   "
16320|NCT02843698|"~     The study aims to investigate the effect of dexmedetomidine on oxygenation and lung~     mechanics in morbidly obese patients~   "
16321|NCT02843685|"~     Many health care interventions and medications found to have benefits (efficacy) in~     experimental, tightly-controlled, human research trials are later found to lack real-world~     health benefits (effectiveness). Inadequate surveillance of real-world clinical~     effectiveness may falsely reassure clinicians and those who monitor healthcare quality,~     propagating unrecognized ineffective or harmful treatments at high costs to patients and~     society. The failure to translate potential health benefits into realized gains, or to~     detect unexpected harms in healthcare delivery, stems from a lack of methods with which to~     robustly measure real-world (in)effectiveness. Current methods to detect changes in outcomes~     'before and after' implementation may be biased by secular trends in healthcare practice and~     outcomes; other methods to compare outcomes for treated and untreated patients may be biased~     by unmeasured factors.~      The current project aims to develop and demonstrate - as a proof-of-concept - the use of a~     quasi-experimental research method called 'regression discontinuity design (RDD)' in~     surveillance of real-world clinical effectiveness. RDD had previously found use in the~     evaluation of educational programs in which students scoring below a threshold were assigned~     an intervention. The US Department of Education considers RDD designs to have quality~     similar to randomized trials.~   "
16322|NCT02843672|"~     INTRODUCTION~      Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of~     surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head,~     shortening and / or raising the metatarsal. It has been somewhat controversial, with more~     than 25 different lesser metatarsal osteotomies described to date.~      The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment~     in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a~     valid technique that yields results similar to open osteotomy for the treatment of~     metatarsalgia and other forefoot problems. It has been somewhat controversial the choice~     between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO)~     and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders~     and retractors surgeons in open and percutaneous surgery.~      The purpose of this study is to compare the clinical results between two different surgical~     treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).~      MATERIAL AND METHODS~      The investigators design an open randomized controlled clinical trial with patients operated~     in the same centre.~      The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the~     criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with~     different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for~     hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal~     percutaneous osteotomy for lesser toes deformities.~   "
16323|NCT02843659|"~     The primary objective of this study is to evaluate the efficacy of treatment with either~     lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's~     syndrome as measured by the change from baseline in ESSDAI at Week 12 between active~     treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.~   "
16324|NCT02843646|"~     The purpose of this study is to investigate the use of the WalkAide, a Neuroprosthetic~     device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that~     with WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and~     independence of completing the task.~   "
16334|NCT02843516|"~     Implantable Loop Recorders (ILRs), are subcutaneous heart monitors, which are implanted for~     different reasons including syncope (fainting), pre syncope (near fainting), palpitations~     and stroke. They monitor the heart and detect abnormalities.~      Atrial fibrillation (irregular heart rhythm),is a common cardiac arrhythmia associated with~     a five-fold risk of stroke. Atrial Fibrillation increases the risk of stroke in patients to~     a different degree according to a risk stratification score. Anticoagulation is recommended~     to all high-risk patients.~      Recent published studies have shown a high incidence of Atrial Fibrillation detected by ILRs~     in patients with previous stroke.~      It is not known whether a similar incidence of Atrial Fibrillation occurs in patients~     without previous stroke. It is also not know ''how much'' Atrial Fibrillation is necessary~     to increase the risk of stroke, how relevant the finding of Atrial Fibrillation is and~     whether everybody with Atrial Fibrillation should have anticoagulation or whether a bit of~     Atrial Fibrillation is actually normal in most people.~      The purpose of this study is to identify and compare the rate and the burden of Atrial~     Fibrillation (more or less than 30 seconds) in patients with and without previous stroke.~      Medical notes and Implantable Loop Recorder records of the patients that had the devices~     implanted in Addendbrooke's Hospital from March 2009 up to 1 month after the implantation of~     the latest device will be inspected in order to identify whether the device had detected~     Atrial Fibrillation and if so the burden of Atrial Fibrillation in the two different groups~     of patients (with and without previous stroke).~      The risk of stroke for each patient will be calculated. Echocardiographic (ultrasound scan~     of the heart)risk factors for Atrial Fibrillation will be identified and compared between~     the two groups.~      This is going to be a retrospective study and we will be inspecting patients' data only.~   "
16335|NCT02843503|"~     Primary objective is to assess the impact of different reference glucose measurement methods~     on the measured performance of a CGM system, aiming at further standardization for the~     assessment of CGM systems. Secondary objective is to describe the relationship between~     glucose concentration of venous, capillary and arterialized-venous measurement samples.~      Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes~     aged 18 years and older will be included.~      Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the~     clinical research center (CRC) twice during a 6 day period. These visits will have a~     duration of 8 hours. Blood will be drawn for the determination of glucose concentrations~     using venous, arterialized-venous and capillary sampling techniques. The patient will~     receive his usual breakfast and an increased insulin bolus will be administered to correct~     the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia.~     Blood sampling will continue until the end of the admission. The sensor will be worn until~     the end of the second 8-hour CRC session, which will be planned on day 6 or earlier~     depending on patient preference. The sensor will be removed and their sensor and blood~     glucose meter data downloaded from the devices. In the case of sensor failure before the~     first CRC session, patients will be instructed to insert a new sensor per the manufacturer's~     instruction and to notify study staff of the event. In case of failure of the sensor after~     the first CRC session but before the second CRC session, patients will return to the CRC for~     sensor removal and for data download.~   "
16336|NCT02843490|"~     Several studies during the last years reported the involvement of anti-retinal~     autoantibodies in ocular disorders, such as AMD. These studies support the growing evidence~     of an immunological involvement in the pathogenesis of AMD. In the planned trial it is~     planned to enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy~     volunteers. The investigators will evaluate the change from Baseline (Visit 1) in BCVA score~     at Week 12 (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular~     AMD patients (group 1) will be accompanied for 6 months and blood samples will be collected~     at baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers~     (group 2) will be enrolled and a blood sample will be collected once for analysis of~     antibody profiles. Antibody profiles of all study participants will be analysed to address~     questions as defined in the outcome measures.~   "
16337|NCT02843477|"~     It is still challenging to assess intravascular volume status in spontaneously breathing~     patients. Recently, the measurement of corrected flow time in carotid artery was introduced~     as quite useful, simple and noninvasive for the evaluation of circulating blood volume~     change. The aim of this study is to evaluate whether corrected carotid artery flow time as~     determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously~     breathing patients before induction of general anesthesia.~   "
16338|NCT02843464|"~     Patients with acute myocardial infarction (AMI) are in critical condition especially without~     emergency reperfusion therapy. For example, heart failure, heart rupture, malignant~     arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may~     play an effective endogenous cardiac protection. This study will investigate whether~     long-term RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients~     without emergency reperfusion therapy. 220 AMI patients without emergency reperfusion~     therapy were randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year)~     or control group (routine treatment). Cardiac troponin (TNI), high-sensitivity C-reactive~     protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible~     factor-1 (HIF-1), echocardiography and magnetic resonance（MR）were detected in hospital, 1~     month and 1 year after discharge. Patients will be followed up by telephone at the end of~     one year. The major adverse cardiovascular events (MACE) include cardiovascular death,~     spontaneous myocardial infarction, unplanned revascularization and stroke.~   "
16339|NCT02843451|"~     The proposed study will consist of a 9 week double-blind cross-over study trial of milk~     thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a~     one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting~     of active treatment with milk thistle, and the other 4 week phase consisting of inactive~     placebo treatment. Participants will be randomized to receive either milk thistle or placebo~     during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS~     pharmacy at the University of Chicago.~   "
16340|NCT02843438|"~     Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop~     learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to~     an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults~     immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical~     diagnosis of ocular toxoplasmosis is more complicated in presence of posterior~     neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs~     heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this~     situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.~      Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the~     host and the pathogen and there can trigger a crossed immune response. Stress proteins~     haven't been explored yet, in the context of toxoplasmosis uveitis on humans.~      The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers~     of ocular toxoplasmosis.~      The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG~     anti-Hsp70) in toxoplasmosis uveitis.~   "
16342|NCT02843412|"~     Background: Gastric cancer (GC) is major global health concern and the second leading cause~     of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the~     Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu~     antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity~     of Her2/neu overexpression and amplification in GC should be noticed. The investigators~     investigated the significance of evaluating Her2/neu expression in different paraffin blocks~     of tumor tissue in GC.~      Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one~     tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin~     blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry~     (IHC). In cohort 2, the investigators combined the results from two different paraffin~     blocks and used the higher one as the final score.~   "
16343|NCT02843399|"~     Primary objective of this study is to compare diabetes-related healthcare utilization and~     costs in patients initiating exenatide once weekly vs insulin glargine.~   "
16344|NCT02843386|"~     After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external~     radiotherapy) patients with high risk of metastasis are randomized between:~        -  Adjuvant chemotherapy with Fotemustin.~        -  Observation~      Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance~     of Fotemustin, quality of life, and Overall Survival.~   "
16345|NCT02843373|"~     The overarching goal of this research program is to elucidate causal and directional neural~     network- level abnormalities in depression, and how they are modulated by an~     individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the~     investigators can overcome a major limitation of EEG - the inability to demonstrate~     causality. Here, we plan to recruit patients with medication-resistant depression undergoing~     rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the~     excitability and connectivity profiles of brain networks and how they are modulated during~     treatment. This study aims to provide objective brain network measures that can predict and~     track clinical response to TMS treatment. Findings from this study will be utilized to~     develop a novel, personalized treatment protocol based on individual brain networks.~   "
16346|NCT02843360|"~     The major elements of the survey were sampling, questionnaire design, field survey and~     database construction. This survey incorporated the multistage stratified sampling scheme.~     Questionnaires include health status, utilization of health care, health behaviors, quality~     of life, and social economic status.~   "
16347|NCT02843347|"~     The STRIDE Biorepository is an optional substudy available to participants in Bone Marrow~     Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN~     1503) (STRIDE).~   "
16348|NCT02843334|"~     Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked~     mutation and characterized by an alpha-galactosidase A (GLA) deficiency. It causes~     globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This~     accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency.~     Due to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated~     incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international~     literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to~     an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other~     organs irreversible lesions, and to enhance the familial screening.~      We aim to conduct a multicentric cross-sectional prevalence study in 5 areas~     (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving~     biologic collection and genetic diagnosis test. Our objective is to measure the prevalence~     of FD among dialysis patients. Eligible patients will be included after signing the informed~     consent.~      In the five participating areas, all of the dialysis centers will be asked for involvement.~     Nominative data of the French renal epidemiology and information network (REIN) registry~     will enable first patients screening for eligibility among prevalent dialysis patients. If~     needed (insufficient or absent data in the REIN registry), data will be completed with~     medical files.~      A blood drop will be collected during a hemodialysis session (or the monthly test for~     peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the~     diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas~     screening in women will be established on the association of alpha-galactosidase activity~     and lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in~     order to confirm the diagnosis for women, and, for all, to offer familial testing. Results~     will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed~     with FD will be managed in accordance with the guidelines of the French National Authority~     for Health (F.N.A.H.).~   "
16349|NCT02843321|"~     To assess the safety and biological efficacy of prophylactically administered donor-derived~     multi-infection specific cytotoxic T lymphocytes (CTLs) (targeting cytomegalovirus (CMV),~     Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza (Flu),~     BK virus (BKV), and Aspergillus (Asp)) combined with early immunisation with Influenza and~     VZV vaccines for the prevention of viral and fungal infection following allogeneic blood or~     marrow stem cell transplantation.~   "
16350|NCT02843308|"~     The proposed study aims to investigate the efficacy of adding in-home decluttering practice~     to Buried in Treasures Workshop (BIT) facilitated group treatment for hoarding disorder.~   "
16351|NCT02843295|"~     Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is~     characterized by a progressive decline in graft function correlating with tissue~     destruction. Recent data suggest that it may be possible to delay graft destruction if~     adequate management is initiated early (ie, at the stage of subclinical CAN). It is~     therefore essential to design new tests allowing physicians to predict transplant recipients~     prone to develop CAN~   "
16352|NCT02843282|"~     The purpose of this study is to examine cognitive and brain changes in individuals with~     bipolar disorder as a result of a cognitive training intervention.~   "
16366|NCT02843100|"~     The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled pilot~     trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine~     whether induction of remission and maintenance of remission can be achieved with a new~     dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with~     Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel~     approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.~   "
16367|NCT02843087|"~     The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered~     offspring from obese and normal weight mothers.~   "
16368|NCT02843074|"~     This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and~     tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the~     induction, consolidation, and maintenance treatment of transplant eligible, newly diagnosed~     multiple myeloma patients.~   "
16369|NCT02843061|"~     The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to~     recurrent B lymphoma.~   "
16353|NCT02843269|"~     Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness~     presenteeism, sickness absenteeism or a combination of these among females with high~     physical work demands. These studies have provided evidence that workplace health promotion~     (WHP) interventions are effective, but long-term effects are still uncertain. These studies~     either lack to succeed in maintaining intervention effects or lack to document if effects~     are maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational~     Muscle pain) is a WHP program among health care workers. A job group characterized by having~     high physical work demands, musculoskeletal disorders, high sickness presenteeism - and~     absenteeism.~      FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism~     and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as~     other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to~     maintain participation to regular physical exercise training, after a one year intervention~     period. The entire concept was tailored to a population of female health care workers. This~     was done through a multi-component intervention including 1) intelligent physical exercise~     training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training~     (CBT).~   "
16354|NCT02843256|"~     Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath.~     Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects~     who were in negative energy balance then fed a positive energy balance meal. Measuring one~     liter of exhaled breath daily may be a more convenient way to measure negative or positive~     energy balance in patients receiving intravenous nutrition.~   "
16355|NCT02843243|"~     A risk stratification in hemodynamically stable patients with acute pulmonary embolism (PE)~     is deemed necessary to guide patient management. With the aim to improve the positive~     predictive value (PPV) for PE-related adverse events in in normotensive patients, a number~     of scores combining multiple risk-factors have been published. In addition, an algorithm for~     the risk-stratification of patients with PE has been proposed by the European society of~     cardiology. None but one of these scores underwent external and prospective validation. The~     aim of this study is to externally and prospectively validate the PPV for PE-related adverse~     events of the Bova score and modified FAST score in a large multicenter cohort.~   "
16356|NCT02843230|"~     This research study aims to predict treatment response to anti-angiogenic therapy (Avastin)~     using advanced magnetic resonance imaging (MRI) and spectroscopy (MRS) for Glioblastoma~     patients.~   "
16357|NCT02843217|"~     Aim: Determine the overall effectiveness of a targeted digital messaging intervention at~     improving colorectal cancer (CRC) screening rates compared to care as usual.~      Hypothesis: Screening rates will be higher for patients who receive the digital messaging~     intervention, compared to the control group in which patients receive care as usual.~   "
16358|NCT02843204|"~     The aim of this study is the safety and efficacy of anti-PD-L1 plus NK immunotherapy to~     multiple solid tumors.~   "
16359|NCT02843191|"~     This trial is to assess the efficacy and feasibility of consolidation chemotherapy after~     neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.~   "
16360|NCT02843178|"~     Improving diets through increased food and vegetable (F&V) consumption significantly reduces~     the risk of cardiovascular disease (CVD). Programs increasing the accessibility and~     affordability of F&Vs among low-income Americans have been hindered by the food consumption~     cycle associated with poverty: the tendency to over-consume calories shortly after receiving~     funds at the beginning of each month, draining the budget for F&V purchases, or for all food~     purchases, by month's end. An emerging theory about dietary behavior suggests that providing~     funds for food in smaller installments distributed throughout the month will smooth the~     consumption cycle and improve healthy eating—counteracting the tendency to respond to lump~     sum, once-monthly funding installments by purchasing calorie-dense foods immediately after~     funds are received. The theory also suggests that funds targeted toward specific healthy~     foods (e.g., F&Vs) will improve diets more than untargeted funds, despite the inconvenience~     of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting~     by comparing alternative approaches for delivering food purchasing vouchers. We have~     established and tested the infrastructure to provide vouchers accepted by numerous food~     sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this~     infrastructure, we will conduct a randomized trial with a two-by-two factorial design,~     comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a~     sequential week of the month (lump sum versus distributed funding), and comparing vouchers~     restricted to F&V purchases to vouchers redeemable for any food (targeted versus untargeted~     funding). Low-income adults (N=288) recruited through our community partners will be~     randomized to one of four 6-month interventions: monthly targeted, monthly untargeted,~     weekly targeted, or weekly untargeted vouchers. Participants will be assessed through~     efficient verbal 24-hour dietary recalls validated among low-literacy populations, to~     determine daily consumption of F&Vs and metrics of overall dietary quality at months 0, 6~     and 12 (6 months after vouchers end). Additional surveys will identify moderators and~     mediators of dietary improvement.~   "
16361|NCT02843165|"~     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)~     combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the~     anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.~   "
16362|NCT02843152|"~     This study use Loewenstein cognitive function rating scale to meet the standards of the~     elderly cognitive function assessment. POCD diagnostic criteria used is the recommended~     value Z current international law, in order to reduce the effects of exercise, we selected~     50 cases of patients with age-matched healthy control group as a spouse, the same scale~     testing. And Loewenstein Assessment Scale cognitive function after some domestic research~     proved to have good sensitivity, and easy to test small changes in cognitive ability.~      Before the investigation began strict inclusion and exclusion criteria, the use of simple~     intelligence scale exclude preoperative cognitive decline in the elderly significantly, the~     use of depression rating scale for anxiety rating scale before surgery to exclude severe~     depression and severe anxiety in elderly self self patient. Testing by the same person in~     the same way neurocognitive assessment test twice, 7 days apart.~      Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few~     reports of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and~     control groups of different polymorphisms, polymorphisms Discussion Han population of~     postoperative cognitive dysfunction associated with susceptibility to find Chinese Han~     population of postoperative cognitive disorders genetic susceptibility markers, which~     provide scientific screening and early diagnosis of postoperative cognitive impairment at~     high risk in accordance with~   "
16363|NCT02843139|"~     Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood.~     Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested~     as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese~     children at risk for diabetes in future.~   "
16370|NCT02843048|"~     Despite being effective in weight reduction in severely obese patients, bariatric surgery~     (BS) negatively influences bone metabolism and increases the risk of falls thereby~     potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are~     unknown but may be related to calcium and vitamin D malabsorption, changes in the energy~     regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS~     induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D~     supplementation, which provide little benefit.~      Exercise is an effective strategy to prevent bone mass losses in several health conditions.~     However, no study so far has examined the effects of an exercise-training program in the~     prevention of BS induced bone loss. The investigators main goal is to investigate the~     effects on bone metabolism and fracture risk of an exercise-training program specifically~     tailored to improve bone health and balance of patients that underwent BS. The investigators~     will perform a randomized controlled trial on obese patients (n=80; BMI>40 Kg.m-2) elected~     to BS. Patients will be randomly assigned into 2 groups i) a group receiving standard~     follow-up and medical care, or ii) a group that will undergo a 11 months' Exercise Training~     program designed to improve bone health and reduce fall risk plus the standard follow-up and~     medical care. All patients will be assessed i) before the surgery, ii) one month, iii) 6~     months, and iv) 12 months after the surgery. Assessments include: biochemical markers of~     bone turnover (BTM), BMD, bone tissue biomechanical properties, hormones involved in the~     regulation of energy, gastrointestinal and bone metabolism, body composition, BMI,~     nutritional intake, balance, muscle strength, cardiorespiratory fitness and daily physical~     activity. These evaluations will allow the investigators to understand the effects of an~     exercise-training program on bone metabolism of BS patients, contributing also to further~     elucidate the mechanisms underlying BS induced bone loss and fracture risk increase. The~     investigators will use established methods in the literature as well as novel procedures,~     which will enable them to overcome some of the limitations of previous studies. At the end~     of the study the investigators expect to have collected consistent data about whether an~     exercise-training program is or is not able to effectively prevent BS induced bone losses~     and fracture risk increases.~   "
16371|NCT02843035|"~     Primary Objective:~      Part 1:~        -  Evaluate central nervous system (CNS) biomarkers in adult Gaucher disease (GD) type 3~          (GD3) patients that distinguish GD3 from Gaucher disease type 1 (GD1).~        -  Screen adult GD3 patients who qualify for treatment with GZ/SAR402671 in Part 2.~      Part 2:~        -  Evaluate the safety and tolerability of GZ/SAR402671 in adult GD3 patients.~        -  Evaluate the change in cerebrospinal fluid (CSF) central nervous system (CNS)~          biomarkers from adult GD3 patients receiving GZ/SAR402671.~      Secondary Objectives:~        -  Evaluate the pharmacokinetics of GZ/SAR402671 in adult GD3 patients.~        -  Explore the efficacy of GZ/SAR402671 in infiltrative lung disease (IDL) in adult GD3~          patients.~        -  Explore the efficacy of GZ/SAR402671 in systemic disease in adult GD3 patients.~        -  Explore the efficacy of GZ/SAR402671 in neurological function and on exploratory CSF~          biomarkers in adult GD3 patients.~   "
16372|NCT02843022|"~     The purpose of the study is to determine whether a web-based nursing intervention delivered~     during the postpartum period will decrease symptoms of postpartum depression and parenting~     stress.~   "
16373|NCT02843009|"~     Skeletal muscle is the largest organ in the human body and has many important roles in~     determining our physical abilities and overall wellbeing. One major function of skeletal~     muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus,~     tasks often referred to as functional abilities. During healthy ageing muscle size is~     reduced by approximately 0.5-2% a year (known as sarcopenia), with concurrent reductions in~     functional abilities. This can result in a reduction in quality of life and loss of~     independence, both of which are clearly not desirable. The incidence of sarcopenia is around~     20% between 50-70 years and around 50% in those over 80 years, with the absolute numbers and~     the average age of the population rising. One method through which muscle function can be~     enhanced and retard the progression of sarcopenia, across all age groups, is through~     exercise. The effectiveness of exercise will depend on a number of genetic and environmental~     factors, with nutritional intake being one of the most important and easily altered. Recent~     research has suggested that altering the type of fatty acids consumed may have a positive~     effect on muscle function. Little research is yet to be carried out in elderly humans. This~     is important as that findings from animal models are not definitively transferrable to~     humans. The main aim of the current proposal, therefore, is to investigate the effect the~     consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), long chain~     polyunsaturated fatty acids found in oily fish, on the response to a resistance training~     programme in the elderly. A further aim is to determine the mechanisms which result in these~     adaptive responses. The project will be centred round a large 18 week resistance~     training/nutritional (EPA/DHA) intervention with both males and females over the age of 65~     years. There are three main research questions and experiments stemming from this~     intervention. 1) Does the consumption of EPA and DHA result in a greater increase in~     strength, power and functional abilities in response to resistance training? To answer this~     question a series of measures of muscular performance and functional abilities will be~     assessed. 2) Does the consumption of EPA and DHA increase the size and quality of muscles,~     reduce the amount of fat found within the muscle and decrease inflammation? To address this~     question the participants will have MRI images of their muscles and blood samples taken~     before and after the intervention. This will allow the calculation of muscle mass/fat~     content and circulating levels of inflammatory markers. 3) Does the consumption of EPA and~     DHA enhance the activity of the molecules involved in controlling muscle mass after a single~     bout of resistance exercise? For this question muscle samples will be obtained before and~     after a single training session and measure changes in molecules previously identified as~     important in the changes in muscle mass in response to exercise. A fourth aim running~     throughout the proposal is 4) Do males and females respond differently to the combination of~     EPA/DHA and resistance exercise? Differences in protein metabolism have previously been~     noted between genders and yet the investigation of these differences is often overlooked.~     The investigators will investigate this by studying responses in groups of males and~     females. In summary, the aim of the proposed project is to test the hypothesis that the~     consumption of fatty acids found in oily fish will improve the response of an elderly~     population to a resistance training intervention. The major outcome of the proposal would be~     in establishing a beneficial effect of fish oil on muscular adaptation in the elderly,~     opening up a widely available therapeutic strategy for an improvement in the quality of life~     in the elderly population. Such strategies are of particular importance due to the~     increasing age of the UK population.~   "
16374|NCT02842996|"~     With an ageing population, hip fractures are likely to become a significant public health~     burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient~     outcomes and experience underpin the National Health Service (NHS) Constitution in driving~     quality improvement and performance.~      We aim to conduct a qualitative research study to ascertain the important patient and carer~     reported experience measures following hip fracture surgery in the elderly to improve~     quality of care and service provision.~      To learn about patient and care-giver experience to ascertain which aspects are important to~     patients and what can be improved.~   "
16375|NCT02842983|"~     After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90~     bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg~     will be randomised into two groups, esmolol group and control group. Patients allocated to~     esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart~     rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To~     investigate myocardial performance, the investigators will assess Tissue Doppler imaging by~     echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol~     infusion once achieved the predefined heart rate threshold and 72hours after esmolol~     infusion.~   "
16376|NCT02842957|"~     The primary purpose of the current 6-month study is to determine the effect of an~     integrated, comprehensive, individualized, intervention program including dietary, exercise,~     pharmacy, and behavioral counseling on patient performance of the short physical performance~     battery (SPPB) which gives an indication of an individual's ability to perform activities of~     daily living dependent upon lower extremity function. Additional objectives include the~     impact of the intervention on cardiovascular risk factors, and the impact of the~     intervention on other indices of physical function in stage 3-4 CKD patients. The~     investigators hypothesize that patients who participate in this integrated, intensive,~     individualized lifestyle intervention will have higher SPPB scores compared to individuals~     in the usual care group. The investigators also hypothesize that this approach will lead to~     higher adherence rates to the lifestyle recommendations and that those who adhere will also~     show better improvements in the measured variables over time compared to patients who are~     randomly assigned to the usual care group or who comply poorly with the various study~     components.~   "
16377|NCT02842944|"~     The purpose of this study is to compare mechanical ventilation following advice from the~     Beacon Caresystem to that of routine care in patients from the state of requiring invasive~     mechanical ventilation until successful extubation. The Beacon Caresystem will be compared~     to routine care to investigate whether use of the system results in similar care and reduced~     time for weaning from mechanical ventilation.~   "
16378|NCT02842931|"~     Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90~     with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly~     diagnosed patients with DLBCL with intermediate and high risk.~   "
16379|NCT02842918|"~     No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on~     neurodynamic mobility, as compared to a sham intervention. This study aims to determine the~     immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test~     (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic~     limitations.~   "
16387|NCT02842814|"~     Whether and when systemic lupus erythematosus (SLE) patients with stable disease should~     withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for~     disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects~     even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC~     withdrawal in SLE patients with stable disease more than one year and to establish a~     predictive model for flare risk stratification.~   "
16388|NCT02842801|"~     The purpose of the study is to identify the characteristics of young adults with pain in the~     groin, lateral hip or buttock who will benefit from manipulation of the hip.~   "
16380|NCT02842905|"~     Most of us will experience some degree of hearing loss as we get older. Hearing loss can be~     due to genetics, trauma, infections, exposure to loud sounds, toxins or ageing. It can~     affect one or both ears and without treatment causes difficulty with following conversations~     in the home or workplace. Individuals with hearing loss can seek treatment from either an~     audiologist or a physician. An audiologist specializes in identifying, diagnosing, treating~     and monitoring disorders of the auditory and vestibular system portions of the ear.~     Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also~     dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly,~     however they diagnose hearing loss and can recommend hearing aids amongst other treatments~     for hearing loss. It is undecided whether consulting with a physician in addition to an~     audiologist will improve the acceptability of hearing aids to potential users compared to~     consulting with an audiologist alone.~      The purpose of this study is to determine whether physician involvement (in addition to an~     audiologist) in the hearing aid fitting process will benefit patients. The study utilizes~     questionnaires to assess satisfaction and benefit from hearing aid fittings. Furthermore,~     participants decision to keep the purchased hearing aids will be recorded.~      The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons~     and audiologists. A hearing aid suitable for the needs of the participant will be fitted by~     an audiologist. In the first 21days after the fitting, participants will attend follow-up~     visits with the audiologists for adjustments to the hearing aids to best meet their specific~     listening needs. After 21 days, eligible participants will be allocated to either the~     Control or Test groups. During Phase II the participants will have a follow-up visit with an~     audiologist (Control group) or their referring physician (Test group). During this visit~     participants in both groups will be asked to describe the change in their hearing~     performance related to the use of hearing aids. The study involvement time for each~     participant will extend over a period of 90 days. At the study's end visit, participants~     will be asked to complete a questionnaire.~      The time taken to fit a hearing aid varies depending on the individual needs of the patient.~     It is estimated that at most 10 visits will be required over 90 days to complete the hearing~     aid fitting and study processes. These visits will be of 30 minutes duration on average,~     except for the initial and final visits which lasts for 45 minutes. A patient will spend a~     maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of~     this time will be specifically related to the study.~      Each participant is under no obligation to retain the hearing aid if s/he is not satisfied~     with the hearing device, nor will any of the study investigators pressurise the participants~     to retain the hearing device. The study is not intended to provide participants with hearing~     aids, but rather to determine the benefit derived from hearing aids and consultations with~     health professionals.~   "
16381|NCT02842892|"~     For optimal jumping performance an adequate interaction of muscles and tendons is required.~     A parameter in the functional evaluation of both structures is their stiffness (resistance~     of the tissue against deformation by external forces). It is unclear so far if higher~     stiffness values of tendon or muscle or a specific stiffness relation of both tissues is the~     cause of better jumping performance. The present study examines this based on the Achilles~     tendon and the calf muscles or the patellar tendon and the hamstrings by three different~     forms of jumps (squat jump, counter-Movement Jump, Drop-Jump).~      The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional~     study, the jump height of the participants will be measured for each jump form: squat jump~     (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into~     the knees) or drop jump (jump from small box with direct re-jump). The order of the jump~     form is determined randomly. The measurements are carried out within one day. Furthermore~     the international physical activity questionnaire will be used in order to assess the level~     of physical activity.~      As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and~     patellar tendon will be detected. The measurement is carried out before the jumps (there are~     three jumps after one sample jump performed). The measurement is executed non-invasively and~     completely painless using Indentometers and MyotonPro. With both devices, minimal pressure~     on the examined tissue will be exerted and measured how much of this can be compressed.~   "
16382|NCT02842879|"~     The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital.~     Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop~     score < 6, gestational age > 41 weeks or medical indication for induction of labor.~      Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.~      The primary outcome will be to compare the variation of Bishop score (difference between~     Bishop score before and after application of Foley catheter) between outpatient and~     inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter~     application-to-delivery time, inpatient time, sequential use of prostaglandins, infection~     and maternal pain.~   "
16383|NCT02842866|"~     The aim of the study is to demonstrate non-inferiority of immunogenicity and evaluate the~     safety of a single dose of MenACYW conjugate vaccine compared to a single dose of Menomune®~     - A/C/Y/W-135 in adults 56 years of age and older in the US.~      Primary objective:~        -  To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine compared to those observed following the administration of a single~          dose of Menomune® - A/C/Y/W-135.~      Secondary objective:~        -  To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups~          A, C, Y, and W following the administration of MenACYW conjugate vaccine to those~          observed following the administration of Menomune® - A/C/Y/W-135~      Observational objectives:~        -  To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by~          hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW~          conjugate vaccine or Menomune® - A/C/Y/W-135.~        -  To describe the safety profile of MenACYW conjugated vaccine compared to that of the~          licensed Menomune® - A/C/Y/W-135 after a single administration.~   "
16384|NCT02842853|"~     The purpose of the study is to demonstrate the immune lot consistency of the antibody~     responses to meningococcal serogroups A, C, Y, and W following the administration of a~     single dose of MenACYW conjugate vaccine and to demonstrate the immune non-inferiority of~     the antibody responses to meningococcal serogroups A, C, Y, and W following the~     administration of a single dose of MenACYW conjugate vaccine vs licensed MCV4 vaccine.~      Primary Objectives:~        -  To demonstrate the immune lot consistency of the antibody responses to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine with respect to serum bactericidal assay using human complement~          (hSBA) geometric mean titers.~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the~          administration of a single dose of licensed MCV4 vaccine.~      Secondary Objective:~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the~          administration of a single dose of licensed MCV4 vaccine in the adult population (18 to~          55 years old)~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the~          administration of a single dose of licensed MCV4 vaccine in the adolescent population~          (10 to 17 years old)~      Observational Objectives:~        -  To describe the safety profile of MenACYW conjugate vaccine and that of the licensed~          MCV4 vaccine.~   "
16385|NCT02842840|"~     Stroke is a major cause of morbidity and mortality, especially in low and middle income~     countries including Iran. Patients with recent stroke or TIA are at high risk for new~     vascular events. Several evidence based strategies in secondary prevention of stroke are~     available but frequently underused. The study is aimed to evaluate an intervention to~     improve patients with Stroke.~   "
16386|NCT02842827|"~     This is a Phase 1 open label study of the dose and duration of an orally administered LSD1~     inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic~     syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known~     as tretinoin and Vesanoid®) in combination with IMG-7289. This study investigates the~     following:~        -  The safety and tolerability of IMG-7289, with and without ATRA~        -  The pharmacodynamic effect of different IMG-7289 doses and treatment durations, as well~          as IMG-7289 administered in combination with ATRA~        -  The pharmacokinetics of IMG-2789, with and without ATRA~   "
24080|NCT02741973|"~     The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for~     school sports to evaluate potential effects in stress reduction and concomitant~     psychological parameters.~   "
16389|NCT02842788|"~     Prone positioning has been shown to improve survival in patients with acute respiratory~     distress syndrome (ARDS). However, a recent large observational study found that prone~     positioning was used in only 7% of all ARDS patients, and 16% in the severe category.~     However, this study did not focus on the prone position per se. In present study, the~     investigators would like to explore the rate of use of prone positioning in ARDS patients~     and the reasons why this treatment was not applied. The present study is one-day prevalence~     study repeated four times over one year.~      The hypothesis is that the rate of use of prone position is greater than 50% in the severe~     ARDS category.~   "
16390|NCT02842775|"~     Cervical myelopathy is common among aging population.One of the complication of cervical~     myelopathy is balance impairment.In this study, the patients with cervical myelopathy~     undergo biomechanical, imaging and functional assessment. The dynamic balance training is~     introduced to the patients with cervical decompression surgery.This study is expected to~     provide important empirical evidence to guide postoperative rehabilitation of myelopathy~     patients and improve patients' long term quality of life.~   "
16391|NCT02842762|"~     This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the~     operating room in cardiac surgical patients. Each patient will serve as his own control,~     following a paired design.~   "
16392|NCT02842749|"~     To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with~     local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine~     tumors.~   "
16393|NCT02842736|"~     The purpose of the study is to evaluate the safety and effectiveness of the Cerene~     Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding~     (menorrhagia) due to benign causes for whom child bearing is complete.~   "
16394|NCT02842723|"~     Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection~     and protontherapy to management paediatric craniopharyngioma.~   "
16395|NCT02842710|"~     The main objective of this study and to know the incidence of healthy carriers of~     Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur~     .~      This assessment will be made preoperatively by a nasal sampling and analysis through it by~     rapid Polymerase Chain Reaction method GeneXpert® .~   "
16396|NCT02842697|"~     This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers~     designed to determine the diagnostic performance of virtual hepatic venous pressure gradient~     (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for~     non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients~     with compensated cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by~     means of catheterization of a hepatic vein with a balloon catheter is the gold-standard~     method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.~   "
16397|NCT02842684|"~     Preoperative planning has been carried out to allow for response preparedness . A layer~     technique is usually used with standard radiography .The investigators have a record of~     routine preoperative radiographs by standard recognized as having an advantage over the~     reproducibility of measurements compared with plain radiography . The Toulouse Hospitals~     have developed this technology and is part of the routine assessment of hip prothesis pre~     and postoperatively.~      The TraumaCad software can superimpose implants on Picture Archiving and Communication~     System and evaluate digital and reproducible size of the implants and their correct position~     .~      This is to demonstrate the superiority of modern digital tools in the preoperative~     preparation in Orthopaedics set.~   "
16398|NCT02842671|"~     The investigators are evaluating the implementation and the effectiveness of a medical~     student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder~     coming into Penn State Hershey Children's Hospital for a medical procedure. The ASAP program~     involves training and assigning a medical student as an Ambassador to help advocate for the~     special needs of a child with ASD. This study is designed to compare patient satisfaction of~     children and families who are assigned an Ambassador to those who are not assigned an~     Ambassador during the procedure. The secondary objectives are to measure overall medical~     student satisfaction with the program, medical student career interests before and after~     participation, and medical student comfort level interacting with children with ASD before~     and after participation.~   "
16399|NCT02842658|"~     The purpose of this study is to determine whether a supervised exercise-training program,~     initiated prior to chemotherapy induction (pre-conditioning) and continued throughout~     chemotherapy treatment, can preserve short- and long-term cardiovascular performance,~     skeletal muscle function, cognitive ability and quality of life better than current standard~     or care recommendations for exercise during chemotherapy.~   "
16400|NCT02842645|"~     Children exposed to alcohol or drugs during pregnancy: Growth, health and development~     Background Children exposed to drugs during pregnancy are at risk of developmental~     disorders. The scope and size of this problem is poorly known in Norway.~      Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is~     associated with more uncertainty. Withdrawal in the neonatal period has been perceived as~     the main problem. There is less knowledge about long-term outcome of exposure to drugs~     during pregnancy.~      Aim The aim of the study is to investigate the physical and mental health of children~     exposed to drugs during pregnancy. Identify the children's need for measures in the home and~     school, and how many of the children who are taken care of in fostercare.~      A sample of the children will be offered radiological examination of the brain (f-MRI). The~     purpose is to study the relationship between exposure to drugs, child development,~     environment and organic brain dysfunction.~      Design The project is a quantitative study. The relationship between exposure to drugs and~     development will be measured by questionnaires, clinical examination, neuropsychological~     tests and radiological examination (f-MRI).~      Children aged 2-15years who were referred, examined or treated for drug related problems at~     the Department of Pediatrics, Haukeland University Hospital will be invited to participate~     in the study.~      Information retrieval and examination of the children are expected to be completed during~     2011. Data analysis and further processing of data are expected to be completed during 2013.~   "
16458|NCT02841891|"~     The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled,~     multicenter technical feasibility clinical study comparing standard anastomosis closure~     technique (Control) to standard closure techniques plus Sylys® Surgical Sealant (Test)~     during colorectal and ileorectal anastomosis procedures.~   "
16401|NCT02842632|"~     Training in TEE is based on hands-on training in the operation room which is time consuming~     and therefore its use and experience is limited among anesthesiologists.~      Recent studies demonstrate that simulation-based education is also superior to a~     conventional didactic system and superior to hands-on teaching in the OR in terms of~     theoretical knowledge in echocardiography. So far there is no study evaluating the study~     effect in obtaining the 11 basic TEE views as recommended by the American Society of~     Echocardiography (ASE) and the Society of Cardiovascular Anesthesiologists (SCA) between~     simulator training and training in the operation room in residents with no prior knowledge~     of echocardiography. The basic TEE examination focus on the 11 most relevant views.~      Therefore the investigators want to assess if there is a difference in the study effect in~     obtaining the 11 basic TEE views and also in theoretical knowledge in 3 groups of residents~     with no prior knowledge of echocardiography:~      the simulation group (CAE Vimedix Simulator), the hands-on OR group and the online group~     (http://pie.med.utoronto.ca/TEE/).~      prospective randomized single-center study. The investigators want to include 51 anaesthesia~     residents (17 per group) in their first or second year of training with no prior knowledge~     of echocardiography in this randomized, Controlled single-centre study.~      The investigators want to assess the pre- and post training scores of the theoretical~     multiple choice test and the practical test in all 3 groups. The multiple choice test~     consists of 50 questions with 1 point per question (max. 50 points) and the practical test~     is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix~     Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria~     including image angle, overall clarity and visualization of 3 major anatomic structures~     pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum~     of 109 (ME asc. aortic LAX has only 2 main structures). Further the time to adjust each view~     and the time to complete the basic TEE Examination will be assessed.~   "
16402|NCT02842619|"~     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II~     as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived~     cells in reconstructing bone in two clinical indications:~        1. Bone augmentation (e.g. sinus augmentation)~        2. Bone grafting after removal of cysts from jaws~   "
16403|NCT02842606|"~     Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years,~     therefore, there have been considerable efforts to identify strategies for prevention and~     management of risk factors. The diet, with its pleiotropic effects, is one of the most~     effective approaches to reduce the cardio-metabolic risk. In this context, the dietary~     fibers have been extensively studied and the available evidence supports the beneficial~     effects of its consumption. However, worldwide the average fiber consumption is still less~     than the recommended daily dose. For this reason, the availability of functional foods, such~     as additional sources of fiber in the diet, may facilitate the attainment of fiber~     recommended.~   "
16404|NCT02842593|"~     This study evaluates the effects of two types of resistance exercise training~     (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and~     local measures of arterial stiffness in trained young men.~   "
16405|NCT02842580|"~     The intensity of tumour response appears to be correlated with the feasibility and the~     duration of a therapeutic pause or of a reduced maintenance therapy maintained until~     progression in patients initially controlled by so-called induction chemotherapy.~     Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has~     shown that it is possible to improve the tumour response rate and patient prognosis in 1st~     and 2nd lines. With a very favourable safety profile , it is an excellent candidate as~     induction treatment and also as maintenance treatment. Prospective data from recent trials~     have actually demonstrated improvement in PFS and/or overall survival with bevacizumab~     maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy~     (FOLFIRI or FOLFOX + bevacizumab).~      At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line~     metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab~     maintenance in 2nd line metastatic, despite progression, thus appears to be a valid~     strategy.~   "
16406|NCT02842567|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The~     pathogenesis of NAFLD is generally considered the result of a series of liver injuries,~     commonly referred as multi-hit hypothesis. Several studies suggest that inflammatory~     pathways and oxidative stress could be responsible of disease progression to non-alcoholic~     steatohepatitis (NASH).~      Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with~     antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several~     anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation~     and platelet aggregation.~      Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with~     conflicting results. It inhibits proinflammatory cytokine production and attenuates the~     release of profibrogenic agents and liver collagen.~      The purpose of this interventional study is to evaluate the efficacy and tolerability of~     Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.~   "
16407|NCT02842554|"~     The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/~     Placebo Administration (DPA) training to increase subjects' ability to discriminate between~     active and placebo treatments in a double-blind crossover trial of a known analgesic,~     measured by standardized effect size, relative to untrained control subjects.~   "
16408|NCT02842541|"~     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and~     pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in~     subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1~     dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will~     initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3~     dose levels. Safety will be assessed over the 28 days after the single dose prior to moving~     to the next higher dose level. Once all subjects in the single dose arm have been dosed with~     EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the~     repeat dose arm. Subjects in the repeat dose arm will receive one dose each month for 3~     months and will be assessed for safety. Escalation to the next higher dose will occur once~     it is determined safe to proceed to the next dose level. Six subjects will be dosed at each~     of the 3 dose levels.~   "
16409|NCT02842528|"~     The purpose of this study is to specify the cognitive and genetic pattern associated with~     alcohol dependence. Results will help identifying more precisely vulnerability factors~     associated with this disorder.~   "
16422|NCT02842359|"~     Primary Objective:~      To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each~     irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients~     diagnosed with hyperlipidemia, hypertension.~      Secondary Objective:~      To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin~     fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and~     hypertension, with adequately controlled blood glucose levels in groups.~   "
16410|NCT02842515|"~     Current endodontic treatment are based essentially on the ouster of parenchyma in case of~     trauma or irreversible pulp inflammation. These situations typically affect immature teeth~     in subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to~     discontinuation of root development and apical closure. The challenge for the clinician in~     the management of such situations is then preserving a pulp vitality. But current practices~     consist in a filling of the endo-canal system with an inert or semi-inert material. In this~     case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is~     the study the feasibility of preparing an autologous combined advanced therapy medicinal~     product (ATMP) for dental pulp regeneration in the patient with irreversible pulp~     inflammation or dental trauma.~   "
16411|NCT02842502|"~     This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product)~     production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7)~     with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary~     biopsies are planned to be done in order to be transferred to laboratory. Then, the~     possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use~     for skin substitute production in clinical condition is evaluated (primary outcome).~   "
16412|NCT02842489|"~     The purpose of this study is to determine whether the left lateral tilt-down position, which~     includes procedures that involve placing patients on their left lateral side at an angle to~     make their heads lower than their feet, is more beneficial than the left lateral horizontal~     body position (patient horizontally laying on their left side, traditionally used for~     colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy~     procedure and patients' pain.~   "
16413|NCT02842476|"~     The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell~     Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as~     compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal~     is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is~     expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry~     System will meet a specification of 3 or better in non-motion conditions for the range of~     70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.~   "
16414|NCT02842463|"~     The purpose of this study is to determine, if it exists, a relation between plateau heart~     rate from the last 3 minutes of the 6-minute stepper test and heart rate from first~     ventilatory threshold from cardiopulmonary exercise testing in order to individualise~     pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary~     disease.~   "
16415|NCT02842450|"~     The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and~     possibly additional examinations including endoscopy and imaging; any of these steps of the~     diagnosis can only be replaced by another.~      In the absence of data in the literature on the evaluation of specific LAP Crohn inspection,~     Clemence Horaist et al established definitions of these lesions inspection with the help of~     an expert group, then evaluated the diagnostic agreement LAP these definitions in the same~     group from a selection of photographs. Definitions ulceration, fistula, inflammatory~     external os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)~      The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is~     appropriate that recognizes and adopts adequate care, this care has been a consensus in~     2014. The interns Hepato gastroenterology must learn during their training to know the~     terminology of LAP Crohn inspection and to recognize so considered acceptable by experts.~   "
16416|NCT02842437|"~     The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in~     patient with sepsis undergoing cleaning focus of infection.~   "
16417|NCT02842424|"~     Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces~     progressive narrowing and occlusion of the arteries supplying the lower extremities. The~     most common clinical manifestation of PAD is claudication, i.e., a severe functional~     limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by~     rest. The standard therapies for claudication include the medications cilostazol and~     pentoxifylline, supervised exercise therapy and operative revascularization. Recent data~     demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE)~     inhibitor Ramipril produces improvements in the walking performance of patients with~     claudication that are higher than those of cilostazol and pentoxifylline and similar to~     those produced by supervised exercise therapy and operative revascularization. The~     mechanisms by which Ramipril therapy produces this impressive improvement in the functional~     capacity of claudicating patients remain unknown. The Investigators hypothesize that~     treatment of claudicating PAD patients with Ramipril will improve walking performance and~     quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a~     consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle~     cells and reduced collagen deposition in the affected gastrocnemius.~   "
16418|NCT02842411|"~     Chronic constipation is one of the risk factors of inadequate bowel preparation, which could~     influence the effect of colonoscopy. The risk factors associated with inadequate bowel~     preparation in constipated patients remains unclear. Here the investigators investigated the~     high risk factors which might have influence on bowel preparation quality in a prospective~     cohort of patients with functional constipation.~   "
16419|NCT02842398|"~     The purpose of this study is to determine if selected sequence training using the Balance~     Master, added to established physical therapy treatment programs, will increase gait~     velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation~     to their ability to cross an intersection within the confines of community traffic signal~     (>120 cm/sec).~   "
16420|NCT02842385|"~     Changes in the marginal bone level surrounding the implant are the frequently used~     parameters in assessing the short- and long-term success. Multiple biological and~     biomechanical factors have been reported to adversely affect marginal bone level. Recently,~     initial vertical mucosal tissue thickness has also been reported to have an impact on bone~     stability.The hypothesis of present study is that soft tissue thickness on implant placement~     has no positive impact of crestal bone remodeling.~   "
16421|NCT02842372|"~     This is a non-interventional prospective study to investigate the treatment response to~     topical application with Ectoin Dermatitis Cream 7% as first-line therapy of grade I acute~     skin graft-versus-host disease.~   "
16424|NCT02842333|"~     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human~     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study~     tumor-specific CD4+ T cell responses.~      The aim of this prospective preliminary study is to evaluate the presence of UCP-specific~     Th1 responses in patients in complete remission of CML two years after end of Tyrosine~     Kinase Inhibitor (TKi) treatments.~   "
16425|NCT02842320|"~     The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic~     myelogenous leukemia (CML).~      Its effectiveness in controlling the progression of the disease is such that it is possible~     today to consider stopping treatment in patients with deep molecular response (> RM4.0).~      Only in about 50% of cases, patients relapse. It has been shown in these patients that~     hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These~     cells are probably at the origin of relapse. It is therefore necessary to develop~     complementary therapies to cure the disease and consider discontinuation iTKs The~     development of anti-tumor immunotherapy approach using genetically modified T cells to~     express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address~     this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.~   "
16426|NCT02842307|"~     This is an expertise-based randomized controlled trial. The hypothesis of this study is that~     the differences in expertise of acupuncturist may impact clinical effect. In this study,~     patients will be randomized to 4 group, receiving the treatment from senior acupuncturist,~     junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive~     the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of~     treatment is from the first day receiving cisplatin until two days after cisplatin on each~     group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.~   "
16427|NCT02842294|"~     The primary aim of this french multicenter national study is to assess and compare time to~     quality of life score deterioration (targeted dimensions : global health, fatigue and~     emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated~     with bevacizumab in metastatic colorectal patients.~   "
16428|NCT02842281|"~     This study evaluates whether the gut microbiome is involved in determining whether children~     with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given~     fructans (a sugar often found in wheat). Participants will both receive a diet with fructans~     and a diet without fructans.~   "
16429|NCT02842268|"~     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after~     exercise compared to the full coverage observed prior to exercise.~   "
16430|NCT02842255|"~     This study is about the development of a new medical device for the monitoring of of sleep~     disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of~     an oximeter, an actimeter in order to measure the activity level of the subject, his state~     of sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).~      Developing this device is realized in several steps : a study (ALMOST) is already in~     progress and its goal is to acquire a database of polysomnography to create automatic~     algorithms in order to detect respiratory disorders with this device under development.~      The main goal of the study is to calibrate the oxymeter under development.~   "
16431|NCT02842242|"~     The purpose of this phase 2 open-label pilot study is to evaluate the efficacy,~     pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in~     subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.~   "
16432|NCT02842229|"~     This is a post-authorization, retrospective multicentre observational nationwide study~     (PAS-OD). It will be conducted by reviewing medical records and database of patients who~     participated in the validation of the psychometric properties of the GAH study~     (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be~     collected to ensure its retrospective nature, thereby reflecting routine clinical practice~     and non-interference in the physician's clinical practice~   "
16433|NCT02842216|"~     Monocentric study in University Hospitals Leuven (campus Gasthuisberg).~      Hospital medical records from all pregnant women who delivered between 01/07/2015 and~     31/12/2015 in University Hospitals will be analyzed for the presence of medication and~     supplements.~      Some demographic and obstetric parameters will be collected as well.~      The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be~     no intervention among the selected sample.~   "
16434|NCT02842203|"~     This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker~     and as a monitor of disease recurrence in stage III colorectal cancer (CRC).~   "
16435|NCT02842190|"~     Mechanical ventilation is important in the care of preterm infants with respiratory failure,~     but may be associated with lung injury. Efforts are needed to avoid or minimize the use of~     mechanical ventilation. However, there is no consensus on the best non-invasive ventilation~     mode after extubation in preterm infants.~      Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation~     (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following~     extubation in preterm infants ≤ 1250 g birthweight.~   "
16436|NCT02842177|"~     The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive~     method. It is also sound safe and cheap contraceptive methods available and is nearly~     maintenance free for up to 10 years.~      The fear and the pain associated with intrauterine devices insertion consider barriers to~     using this contraception method, this is because that the mucosal lining of female genital~     tract is highly sensitive to touch and pain. However; most of small procedures done in this~     sensitive area are performed without analgesia.~      The pain during intrauterine devices insertion is due to application of the tenaculum ,~     traction of the cervical canal, passing the uterine sound, insertion of the intrauterine~     devices through the cervix, and irritation of the endometrial lining by the intrauterine~     devices .~      Previous studies have reported different lines to decrease pain during intrauterine device~     insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or~     intrauterine lidocaine and misoprostol up to paracervical blocks.~      Previous studies, in literature, have found that the most painful steps during intrauterine~     devices insertion were uterine sounding then intrauterine device insertion itself, followed~     by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum~     and a single-tooth tenaculum on pain perception during intrauterine devices and found no~     difference in reported pain.~   "
16437|NCT02842164|"~     Induction of abortion is a hot subject that has complex and emotional controversy. The most~     common time of abortion is the second trimester which represent about 10-15% of all induced~     abortions over the world. As well as, two-thirds of all serious abortion-related~     complications are related to induced second trimester abortion.~      There are many causes for induction of abortion in the second trimester such as missed~     abortion, serious fetal abnormalities such as central nervous system or skeletal~     malformation and lastly some women do not wish to continue a pregnancy and will often seek~     out termination of pregnancy.~      Termination of second trimester is more risky than the first trimester. So many lines have~     been emerged to achieve safe and effective method of termination of second trimester.~      Pharmacologic management seems to be an appealing method for induction of abortion. The~     combing between mifepristone and misoprostol is the effective regimen for termination of~     second trimester abortion with success rate reaching about 97-99% within 24 hours.~      However, mifepristone is not available or affordable in many countries worldwide so~     misoprostol have been used alone but it needs higher total dose with lower effectiveness and~     higher percentage of side effects rate than the combined regimens.~      The optimal method for inducing second trimester nulliparous women with an unfavorable~     cervix is not known. Several studies in literature have described the effectiveness of~     Foley's catheter in cervical ripening and improvement of Bishop's score in women with unripe~     cervices . It may act in addition to its mechanical effect by increasing the release of~     prostaglandin and/or oxytocin release secondary to localized inflammation.~      In practice, the insertion of intra-cervical Foley's catheter balloon is followed by~     applying tension in trial to shorten the time between the insertion and expulsion of the~     fetus, however; this tension adds more pain for the pregnant women with higher rate of~     vaginal bleeding and dissatisfaction.~      Gary et al in 2016 concluded that the application of tension did not result in faster~     delivery times, but did result in faster times to catheter expulsion.~   "
16438|NCT02842151|"~     The purpose of this study is to evaluate current available assessments (automated vs.~     manual) with which manifest refraction data and biometric variables are obtained to~     understand if data from an automated refractor can be utilized to optimize the A-constant as~     well as manual subjective refraction (ie, to a clinically insignificant difference). The~     A-constant is the calculated number that helps the surgeon determine which IOL should be~     implanted in the eye during cataract surgery.~   "
16439|NCT02842138|"~     This is a single arm, open-label, one center, dose escalation clinical study to determine~     the safety and efficacy of infusion of autologous T cells expressing CD19-redirected~     Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19~     positive B-cell lymphoma.~   "
16440|NCT02842125|"~     This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in~     combination with oral metronomic capecitabine in patients with unresectable, refractory~     liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary~     hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design. The Maximum~     Tolerated Dose (MTD) will be determined as well as the general safety and preliminary~     efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be~     followed.~   "
16441|NCT02842112|"~     Over recent decades, improvements have been made in the treatment of adult acute myeloid~     leukemia (AML). This has been mainly attributed to improvements in supportive therapy and to~     intensification of treatment strategies. The introduction of a post-induction myeloablative~     regimen followed by allogeneic stem cell transplant (SCT) has reduced the relapse rate in~     younger adults. However, this procedure is limited by the availability of human leukocyte~     antigen (HLA)-identical donors and conventional SCT preparative regimens according to~     patient age. In the absence of a compatible donor, myeloablative chemotherapy followed by~     autologous peripheral blood (PB) SCT remains one treatment strategy in adult patients with~     AML, allowing 35 - 50% long-term survivors. Despite several advantages of the CD34+ cell~     mobilization procedure, recent data have shown that relapse was higher and leukemia-free~     survival (LFS) shorter compared with bone marrow (BM) autografts. Higher doses of CD34+~     peripheral blood stem cells (PBSCs) are collected to ensure engraftment and possibly reduce~     the incidence of treatment-related mortality (TRM). Although there is a threshold CD34+ cell~     dose below which engraftment is delayed in AML, the positive linear correlation of the~     number of CD34+ cells and kinetics of engraftment reaches a limit above which an increase in~     the number of progenitor cells does not provide any additional benefit. Relapse has been~     shown to be higher and survival shorter for those who receive the highest CD34+ PB doses.~     Although highly active against the leukemia bulk, intensive chemotherapy often spares the~     hardiest leukemia stem cells (LSCs) responsible for relapse. Detection of minimal residual~     disease (MRD) in autologous PBSC products may reflect inadequate in vivo purging, at least~     in part responsible for relapse. Although representing a heterogeneous cell population~     including both normal and leukemia cells, and despite that recent data have challenged the~     CD34+ CD38- phenotype of LSCs in AML, the CD34+ CD38- cell population generally remains~     considered enriched for LSCs.~      In this setting, MRD remaining during morphological complete remission (CR) should be~     relatively enriched in CD34+ CD38- leukemia cells, and their persistence after CR~     achievement should correlate with disease recurrence. This was investigated in a cohort of~     123 patients with AML following apheresis procedures after CR achievement. The investigators~     also studied the impact of the infused dose of subpopulations of CD34+ PB cells on the~     outcome of a subset of 71 patients who further underwent autologous PBSCT.~   "
16442|NCT02842099|"~     The study is a prospective, randomized phase II clinical trial, to compare the efficacy and~     safety profiles of standard chemotherapy versus standard chemotherapy followed by~     capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.~   "
16443|NCT02842086|"~     The primary objective of this study is to assess the rates of HIV-1 seroconversion in Men~     (MSM) and transgender women (TGW) who have sex with men and who are administered daily~     emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir DF (F/TDF) with a~     minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up.~   "
16444|NCT02842073|"~     This is an open-label Phase IIa pilot study of the tolerability and effects on binge~     drinking of bupropion and naltrexone for binge drinkers and assess cortical adaptation to~     tactile stimuli in subjects with binge drinking.~   "
16445|NCT02842060|"~     This study uses an interactive design and development process to develop tailored messages~     that align YMSM's relationship experiences and desires with HIV prevention strategies. The~     study includes a tailored online prevention, intervention, as well as an attention control~     non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the~     intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability,~     and gather preliminary behavioral data to inform a subsequent application. Follow-up~     assessments will be collected at thirty (30), sixty (60), and ninety (90) days~     post-intervention.~   "
16446|NCT02842047|"~     Caregivers of persons with cancer may face many challenges as they support and care for a~     person receiving treatment. Sometimes having to help make treatment decisions for a patient~     can cause distress for caregivers. The purpose of this study is to evaluate 2 different~     electronic approaches to providing support for a caregiver. One group will have access to an~     on-line program with videos, providing education on decision making strategies for~     caregivers of patients with cancer, to watch and a daily meditation application and the~     other group will have access to the daily meditation application. Investigators will~     randomly assign participants to each group.~   "
16447|NCT02842034|"~     This study is to determine whether high frequency repetitive transcranial magnetic~     stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia~     patients~   "
16469|NCT02841748|"~     A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year~     in order to potentially improve progression free survival in a squamous cell carcinoma of~     the head and neck cohort at high-risk for recurrence.~   "
16448|NCT02842021|"~     To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads~     and vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory~     interdigital tinea pedis in subjects 12 years of age and older. The results of this study~     will be utilized to perform power calculations for the Phase 3 pivotal trials.~   "
16449|NCT02842008|"~     Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball~     players. About the 85% of this population had shoulder pain in some moment of their life.~     Some studies suggest that exercise is an important tool as an element to treat and prevent~     shoulder injuries. For that reason, an intervention program would be a useful tool for~     prevent shoulder injuries in this population.~      The purpose of this study is determine the effects of therapeutic exercise program~     wheelchair basketball players, in order to prevent shoulder injuries.~   "
16450|NCT02841995|"~     This study is being conducted to evaluate the safety, tolerability, and activity of KD025 in~     adult subjects with chronic Graft versus Host Disease (cGVHD).~   "
16451|NCT02841982|"~     This prospective, randomized study,control study aims to compare the analgesic~     effect,opioids consumption,quality of recovery,length of hospital stay and incidence of~     chronic pain,et al. between single-injection QLB(quadratus lumborum block) ,~     single-injection QLB +continuous QLB and intravenous patient-controlled analgesia (IPCA)~     alone in patients undergoing laparoscopic renal surgeries.~   "
16452|NCT02841969|"~     More patients with diabetes mellitus have led to increasing rates of chronic non-healing~     wounds. These wounds are colonised with pathogens, including multi-drug resistant organisms.~     Despite repeated courses of antibiotics subsequent management is difficult due to~     devascularisation of surrounding tissues and healing failures. Ultimately, patients may~     require amputation. Electrolysed water is a novel antiseptic produced by passing an electric~     current through a mixture of tap water and salt. Microbiocidal activity is due to the~     presence of hypochlorous acid at neutral Ph. Irrigation of chronic wounds with electrolysed~     water reduces bacterial load and appears to encourage wound healing. Following an~     encouraging pilot study, we propose to compare electrolysed water against conventional~     management for diabetic patients with non-healing foot ulcers. Adult diabetics with chronic~     ulcers attending podiatry at Hairmyres Hospital will be recruited to receive regular~     debridement and irrigation of wounds using either in-use product (Prontosan™) or~     electrolysed water as part of a prospective randomised controlled trial. Strict enrolment~     criteria will be applied, with regular clinical assessment and microbiological screening.~     Lesions present for >6 weeks and >2cm will be photographed at trial entry and graded using~     standardised criteria. Wounds will be monitored for at least 12 weeks (max. 20), with~     primary composite end-point defined as complete healing; >50% healing of initial lesion;~     and/or avoidance of surgical intervention. Secondary endpoints are surgical intervention,~     including debridement or amputation; antibiotic therapy; and/or patient death. The main~     objective is to compare rapidity of wound healing using either in-use product or~     electrolysed water. Improved healing could potentially benefit patients who might otherwise~     progress to amputation. We will also monitor antimicrobial consumption in study patients~     throughout the trial. A final objective is to cost the use of electrolysed water vs cost of~     Prontosan in the routine management of diabetic foot ulcers.~   "
16453|NCT02841956|"~     Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term~     outcomes in young people with a first episode of psychosis (FEP). The standard of FEP care~     within the US focuses on targeted provider education regarding signs and symptoms of early~     psychosis to motivate patient referrals to FEP services, followed by initiation of services~     within largely clinic-based settings Experience at the Early Diagnosis and Preventive~     Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two~     important bottlenecks to reducing DUP, consistent with reports in the literature from other~     FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral~     sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building~     upon a comprehensive and established referral network of 20 sites across the Sacramento area~     (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the~     investigators will address delays in patient identification and engagement using a~     two-phase, cluster randomized design. The investigators will consecutively test the impact~     of two interventions to reduce DUP, defined in this RFA as time from first onset of~     psychotic symptoms to engagement in FEP specialty care. To address identification delays,~     the investigators will examine the use of standard targeted provider education plus novel~     technology-enhanced screening compared to standard targeted provider education alone,~     testing the hypothesis that the education plus technology-enhanced screening will identify~     more patients, earlier in their illness. To address engagement delays, the investigators~     will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to~     standard clinic-based procedures for intake, engagement and initiation of treatment, to test~     the hypothesis that the mobile approach facilitates earlier and more stable engagement,~     thereby reducing DUP. The proposed work will provide new specific evidence-based practices~     for reducing DUP and improving outcomes through specialty care of individuals with a first~     episode of psychosis.~   "
16454|NCT02841943|"~     Study Design: Prospective observational study~      Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health~     District, Sydney, Australia.~      Target study size: 100 patients~      Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital~     (LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47,~     HREC/LNR/14/LPOOL/150]~      Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between~     March-October 2016~      Aims:~        1. to determine the descriptive and predictive value of variables (outlined below) related~          to oxygen delivery/consumption in regards to the effects of intravascular volume~          expansion~        2. to assess correlations between central and peripheral variables (outlined below)~          relevant to oxygen delivery/consumption~        3. to assess correlations between a set of variables (outline below) and patient centred~          outcomes in ICU and in hospital~      Main variables collected:~        1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)~        2. Common carotid arterial Doppler~        3. Arterial/mixed venous/central venous blood gas analyses~        4. Haemodynamic parameters~        5. Organ support measures~      Data collection time points:~        1. ICU admission (within 30 minutes)~        2. Before administration of a fluid bolus~        3. After administration of a fluid bolus~        4. 6 hours after ICU admission~        5. Morning of first postoperative day (12-24 hours)~      Outcome measures:~        1. the response to intravascular volume expansion~        2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay~      Data analysis:~        1. Clinical data are collected bedside using an electronic case record form~        2. Descriptive statistics~        3. Paired and unpaired comparative~        4. Correlative and predictive statistics~   "
16455|NCT02841930|"~     The ActionHealthNYC program is a year-long demonstration program to improve access to high~     quality health care for NYC resident immigrants who do not qualify for public insurance with~     incomes at or below 200% of the Federal Poverty Level (FPL). The purpose of this study is to~     determine whether improved access and care coordination services provided through the~     ActionHealth NYC program allows participants to have easier access to healthcare~     (particularly primary care and preventive services) than non-participants.~   "
16456|NCT02841917|"~     Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for~     patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with~     severe AS are deemed inoperable due to comorbidities such as severe respiratory disease,~     chronic renal disease and peripheral vascular disease. Transcatheter aortic valve~     replacement (TAVR) has emerged as a novel therapeutic modality for inoperable patients and~     an effective alternative to SAVR in selected high and intermediate-risk patients. Myocardial~     ischemia and reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to~     cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac~     surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter~     time of ischemia and hypotension and may be associated with less ROS mediated MRI.~     Inflammatory responses and reperfusion injury following TAVR have not been previously~     described nor compared to SAVR. The aim of this study is therefore to compare the oxidative~     stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and~     determine whether it correlates with clinical outcomes.~   "
16459|NCT02841878|"~     Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal~     micro-inflammation, epithelial permeability disorder and proteases activity increase have~     been demonstrated in the patients' gastrointestinal tract. Protease activity increase could~     be subjected to a genetic determinism (decrease in proteases inhibitors genes expression).~     Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies~     supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS~     patients and healthy subjects). 2/ Establishing a correlation between proteases activity,~     mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic~     potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in~     subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/~     Demonstration of restorative potential of proteases inhibitors.~   "
16460|NCT02841865|"~     The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor~     size, has been considered as a reproducible method that facilitates not only the measurement~     of the mass but the evaluation of response to given treatments; while classic chemotherapy~     induces a reduction of the tumor, new target therapies frequently produce the stabilization~     of the disease or a delayed progression. These new therapeutic alternatives have shade light~     on the limitations of the RECIST criteria, since the response to these type of treatments~     are basically associated with changes on the radiological characteristics of the tumor, as~     well as other findings in functional imaging.~      This study is aimed to compare the response rates according both Choi and RECIST criteria.~   "
16461|NCT02841852|"~     Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in~     the world and the most effective drugs available to reduce gastric acid secretion. However,~     studies have shown that PPIs are not always prescribed with a clear indication. Indeed,~     between 25% and 86% of older individuals taking a PPI have been overprescribed these~     medications. In older patients, overprescribing of a PPI is associated with increases in~     morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that~     overprescription of PPIs is associated with the individual multimorbidities in older~     patients evaluated using the multimorbidities group criteria included in the CIRS. The aim~     of the present study was to establish a relationship between overprescribing of PPIs and~     multimorbidities in older patients.~   "
16462|NCT02841839|"~     To identify a sampling method for collecting subgingival plaque~   "
16463|NCT02841826|"~     The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible~     contraceptive method. It is also sound safe and cheap contraceptive methods available and is~     nearly maintenance free for up to 10 years.~      The fear and the pain associated with IUDs insertion consider barriers to using this~     contraception method, this is because that the mucosal lining of female genital tract is~     highly sensitive to touch and pain. However; most of small procedures done in this sensitive~     area are performed without analgesia.~      The pain during IUDs insertion is due to application of the tenaculum , traction of the~     cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and~     irritation of the endometrial lining by the IUDs.~   "
16464|NCT02841813|"~     The incidence of preterm birth increases annually. Premature delivery has become the leading~     cause of neonatal illness and death. For the survived premature babies, the incidence of~     sequelae is also higher than the full-term babies, which brings a heavy burden to a family~     and society. Preterm birth has become the important factor affecting the quality of births.~     The occurrence of premature birth is the outcome of combined action of genetic and~     environmental factors. However, its etiology is not clear. Recent studies have shown that~     the risk of preterm birth is associated with dietary factors. Choline is an essential~     nutrient for human health and it plays an important role in the growth and development of~     fetuses and neonates. The investigators previously found that serum levels of free choline~     in preterm mothers were lower than those in normal mothers with full-term birth. Serum~     levels of free choline also reduced in preterms after receiving parenteral nutrition (PN).~     However, the relationships between choline and preterm birth is not clear. Therefore, this~     study is aimed to explore the effect of choline intake during pregnancy and genetic~     polymorphisms on the risk of preterm birth and on the clinical outcomes in preterms~     receiving total PN therapy. Healthy Chinese pregnant women with their healthy term infants~     will be recruited as the control group, while Chinese women with preterm delivery and their~     preterm infants will be recruited as the preterm group. Dietary choline intake during~     pregnancy will be evaluated by semi-quantitative food frequency questionnaire and 24-h~     dietary recall questionnaire. Gene polymorphisms in the key enzymes of choline metabolism~     will be identified among the participated women and neonates through Real-time polymerase~     chain reaction. Choline and its related metabolites will be assayed using high performance~     liquid chromatography combined with mass spectrometry among all mothers and preterms before~     and after 7-days PN treatment. The influence of genetic risk factors and metabolic changes~     of choline on the physical and mental development of preterms will be evaluated. The results~     of this study will contribute to a comprehensive understanding of the role of choline and~     the relative gene polymorphisms on the risk of preterm birth, which will be helpful for~     estimating the high risk in advance. The results will also provide the scientific evidences~     to establish the personalized amount of choline intake among women and infants, optimize~     nutrition support for pregnant women and preterms, and promote better prenatal and postnatal~     care.~   "
16465|NCT02841800|"~     Only a small proportion of patients with biliary obstruction caused by~     hepatopancreatobiliary malignancies are suitable for surgical resection. Therefore, most~     patients with malignant biliary obstruction will need palliation of their obstructive~     jaundice to relieve the symptoms and prevent life threatening complications such as biliary~     sepsis. The endoscopic or percutaneous/transhepatic routes, such as endoscopic retrograde~     cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC), and~     stents are accepted approaches for the relief of jaundice in malignant biliary obstruction.~     Improvement in the bilirubin level is also essential before palliative chemotherapy is~     considered in these patients. However, tumor ingrowth still remains a major cause of~     obstruction. In this trial, the investigators will use HabibTM EndoHPB (EMcision Ltd., UK)~     catheter which was used for the endobiliary radiofrequency ablation (RFA) treatment as a~     form of neoadjuvant therapy in hepatopancreatobiliary adenocarcinoma.~   "
16466|NCT02841787|"~     The goal of this field trial is to tailor and test a web-based intervention in adults 65~     years of age or older. Two versions of the web-based intervention have been created and will~     be tested--one with an online social network and one without an online social network. The~     purpose of this study is to: pilot a novel intervention, examine methods to improve~     adherence to web-based interventions (e.g., peer network); collect data on feasibility,~     acceptability, and efficacy of an web-based intervention for late life depression; and~     ultimately, to overcome the numerous barriers to treating depression in later life.~   "
16467|NCT02841774|"~     HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin~     therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg~     daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart~     disease (CHD).~   "
16468|NCT02841761|"~     The purpose of this study is to evaluate the effect of AC-080 on the pharmacokinetics of~     midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of AC-080 when~     administered alone and in combination with midazolam.~   "
16470|NCT02841735|"~     It is important to explore use of technology to reduce drinking. The purpose of this~     research study is to compare different types of mobile technology for their effects on~     alcohol drinking and ratings of usability among young adults.This study will be conducted in~     four phases: a web-based screening assessment; brief appointment on the day of the alcohol~     drinking session; alcohol drinking session; and a follow-up appointment. Participation in~     this study will last approximately two months.~   "
16471|NCT02841722|"~     The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or~     febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in~     dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical~     response. To avoid those episodes, or to shorten the duration and reduce the associated~     risk, administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended.~     Recombinant G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the~     proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily~     administration (such as filgrastim, lenograstim) and a single administration~     (pegfilgrastim).~      Various international learned societies offer recommendations for primary care, secondary or~     curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal~     time for the administration of growth factors and duration of administration are not very~     clear. If it seems clear that the treatment should not be initiated within the first 24~     hours following administration of chemotherapy, summaries of the characteristics of~     different products do not provide evidence to optimize the administration day depending on~     the kinetics evolution of neutrophils. In addition, no information is given as to the choice~     of a formulation with respect to the other.~      The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the~     evolution of neutrophil function of time and explain the pharmacodynamic variability during~     the administration of chemotherapy based on eribulin. The description of the evolution of~     neutrophils when growth factors are administered give the opportunity to streamline~     administration regimens of these factors and to provide guidance on the circumstances in~     which they should or should not be given while weekly chemotherapy.~      Expected benefits and foreseeable risks With the exception of surplus withdrawals during the~     first 2 cycles of treatment, this study will have no impact on the care of patients.~   "
16472|NCT02841709|"~     The primary objective of this study is to assess the effect of ACT-541468 on a measure of~     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in elderly subjects~     with insomnia disorder.~   "
16473|NCT02841696|"~     Hypertension is a major cardiovascular risk factor. Heart failure is one of its main~     complications but the factors that influence its development are still insufficiently known.~     The primary objective is to determine associated factors to the occurrence of left~     ventricular (LV) systolic dysfunction assessed by an alteration of the Global Longitudinal~     Strain (GLS) after more than the years of hypertension. The secondary objective is to~     estimate the prevalence of LV systolic dysfunction in a cohort of hypertensive people~     followed for over 10 years and formulate pathophysiological hypotheses on the development of~     this heart disease.~   "
16474|NCT02841683|"~     Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS),~     was developed in France to provide an adapted web and mobile application support to smoking~     cessation for all adults smokers, with or without chronic diseases, who want to stop~     smoking. This paper presents the study protocol of the evaluation of the program. The~     primary objective of this evaluation is to assess the efficacy and efficacy conditions of~     eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user~     characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations~     of use, social or environmental contextual factors likely to influence the efficacy of eTIS,~     and the behavior change techniques (BCTs).~      Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial~     including a process evaluation with at least 3000 participants randomized to the~     intervention or to the control arm (current practices presented in a non-interactive~     website). Inclusion criteria are: Adults, Smokers with an information and consent form~     completed, Getting a smartphone and using mobile applications, wanting stop to smoking in~     short, medium or long terms. The exclusion criterion is the refusal to participate in the~     study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later.~     The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the~     point prevalence abstinence of 30 days at 12 months later, number of quit attempts during~     the study, progression of stages within the program (changes and duration in each stage).~     Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic~     regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A~     multivariate multilevel analysis will explore the influence of patients' characteristics,~     social and environmental context, conditions of use and behavior change techniques on~     results.~      Dissemination -The findings of this study will allow us to understand and characterize the~     efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological,~     environmental and contextual factors, which could influence the efficacy of this type of~     intervention on smokers. These findings will be disseminated through peer-reviewed journals,~     national and international conference presentations and public events.~   "
16475|NCT02841670|"~     This is a monocentric, longitudinal, prospective, observational post-market follow-up study.~      30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the~     cataract procedure, data collection will take place during visits planned by the physician~     as part of normal follow-up.~      Patients with cataract will be recruited from the clinic by the investigator based on the~     inclusion and exclusion criteria.~      The patient will be followed up after one day, one week, one month, six months, one year and~     three years post-op. An interim analysis will be performed with one-year clinical results.~      The main objective of the study is to evaluate is to evaluate efficacy and long-term safety~     for the InFo - Instant Focus © lens.~   "
16476|NCT02841657|"~     -  To compare surgical and oncological outcomes in patients underwent to colorectal~          resection with 3D vs 2D laparoscopic technique.~        -  To evaluate the visual overload in surgeons using 3D laparoscopic technique.~   "
16477|NCT02841644|"~     For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the~     joint capsule require formal irrigation and debridement in the operating room to minimize~     the risk of developing septic complications. The literature supporting this practice is~     sparse and stems primarily from wartime injuries that may not be generalizable to the~     smaller, less contaminated arthrotomies seen in the civilian population. Despite the~     classical teaching of all traumatic arthrotomies requiring irrigation, debridement, and~     closure in the operating room, numerous surgeons around the country are beginning to treat~     small traumatic arthrotomies without surgery. The purpose of this study is to evaluate the~     cost of treatment as well as incidence of adverse events, such as the development of septic~     arthritis, in patients undergoing operative and non-operative treatment of traumatic~     arthrotomies.~   "
16478|NCT02841631|"~     Human Papilloma Virus (HPV) has been shown to be a cause of Head & Neck Squamous Cell~     Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients~     with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of~     patients who do not have HNSCC. The current incidence of oral HPV infection is not known in~     the general population locally and there is also limited information on what particular~     localities within the mouth that patients' harbour HPV infection what strains are present~     and if there are any differences in viral load.~      Therefore the aim of this project is to investigate within patients that undergo~     tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present~     within the community.~   "
17038|NCT02834325|"~     The purpose of the study was to describe early predictors and to develop a prediction tool~     that accurately identifies the need for mechanical ventilation in pneumonia patients with~     acute respiratory failure treated with High Flow nasal cannula.~   "
16479|NCT02841618|"~     The purpose of this study is to understand how consuming healthy cookies every day for two~     weeks will affect different types of fat in the blood. Specifically, the overall goal of~     this study is to find out if the healthy cookies can increase a polyunsaturated fat called~     linoleic acid in plasma, red blood cells and white blood cells.~   "
16480|NCT02841605|"~     The close homology between the central and enteric nervous systems suggests that a disease~     process affecting the central nervous system could also involve its enteric counterpart. The~     investigators have recently shown in that the enteric neurons can be readily analyzed using~     routine colonic biopsies. This led us to propose that the enteric nervous system could~     represent a unique window to assess the neuropathology in living patients with a~     neurodegenerative disorder. The investigators have already used this approach to show that~     Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to~     Parkinson's disease, the detection of Alzheimer's disease (AD) pathology in the enteric~     neurons has so far failed. This may be due to the low number of human tissue samples in~     addition to the low sensitivity of the immunohistochemical methods that were used. The aim~     of the current research project will be therefore to reevaluate AD pathology in a large~     number of human colonic samples using both a morphological and biochemical approach .~      The enteric nervous system could represent a unique window to assess the neuropathology in~     living patients with AD. This might open the way to the development of novel AD biomarkers~     that will directly assess the neuropathological process.~      Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system~     (ENS) in AD patients~      Secondary Aim(s):~        1. To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD~          patients~        2. To assess neuronal loss in submucosal tissue in AD patients.~        3. To examine Glia cells in the enteric nervous system in AD patients..~   "
16481|NCT02841592|"~     This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen~     content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device~     at the flush rate, used with active positive pressure assistance.~   "
16482|NCT02841579|"~     The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the~     objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and~     the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.~      Safety and efficacy will also be measured.~   "
16483|NCT02841566|"~     The purpose of this study is to to explore the link between materialism and addiction to~     gambling and money~   "
16484|NCT02841553|"~     In this study, the investigators hypothesize that studying monogenic variants with strong~     effect associated with severe insulin deficiency of Wolfram syndrome will provide important~     insights into the more complex type 1 and type 2 diabetes mellitus.~      Aim 1. Establish and maintain a registry of patients with Wolfram syndrome. An Internet~     based registry will be employed to enroll participants with the clinical diagnosis of~     Wolfram syndrome (insulin dependent DM and bilateral OA). Clinical information regarding age~     of diagnosis and progression of the disease will be collated and analyzed to better define~     its natural history, along with potential metabolic phenotypes such as glucose intolerance~     of heterozygous parents and unaffected sibs.~      If not already completed, blood for WFS1 sequence analysis will be obtained on the~     participants (parents and sibs also for control purposes) and sent to a CLIA certified lab~     to define the mutation. This information will benefit patient families and referring~     physicians by providing a genetic diagnosis and where indicated. The Wolfram Syndrome~     Registry will foster international collaborations to more efficiently and systematically~     collect Wolfram syndrome patients and their clinical and experimental data.~   "
16485|NCT02841540|"~     This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm~     expansion portion. The primary objectives of the study are to determine the maximum~     tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in~     participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic~     Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a~     single agent administered orally once daily on a 5 days on/9 days off repeated dosing~     schedule in 28-day cycles in participants with MDS, AML, or CMML.~   "
16486|NCT02841527|"~     Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to~     worsen.~      In the UK and worldwide the three most commonly performed operations are laparoscopic~     adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and~     laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated~     with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target~     recruitment of 1341 patients in eleven hospitals and its aim is to compare the~     effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.~   "
16487|NCT02841514|"~     Study title: The Efficacy and Safety of tooth bleaching procedure using Y10 Whitening~     toothpaste and RF current~      The Device: The Brighttonix Y10 Tooth Whitening system is indicated for use in painless~     non-invasive tooth whitening treatments.~      Design: Single center, randomized, controlled, double blind, two-arm, prospective clinical~     study.~      Follow up visits at 7 days (phone visit), 12 weeks and 26 weeks.~   "
16488|NCT02841501|"~     This is a prospective case-control physiopathological study, which main objective is to~     determine the genetic host factors predisposing to candidemia. Secondary objectives are to~     develop new diagnosis tools using the biological collection, to describe and update~     epidemiology, to analyse the influence of genetic polymorphisms on prognosis.~   "
16489|NCT02841488|"~     This project is one of four components of a thematic project that aims to evaluate the use~     of ultrasound in regional blocks, called Use of ultrasound in regional blocks and~     injections for the treatment of acute and chronic pain.~      It will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in~     patients with peripheral arterial occlusive disease through continuous sciatic nerve block~     by perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.~   "
16506|NCT02841267|"~     The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that~     neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular~     Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.~      This study will provide the clinical assessment of the safety, tolerability,~     Pharmacokinetics and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory~     adults with LGMD2I.~   "
16490|NCT02841475|"~     Atrial fibrillation (AF) is a common condition whose prevalence increases with advancing age~     . One of the main complications of this arrhythmia is the occurrence of systemic~     thromboembolism, the first of which the occurrence of cerebrovascular accident (CVA) . The~     advanced age itself is an independent risk factor for occurrence of stroke in the context of~     AF , evidenced by the score awarded to the age over 75 years in the risk estimate~     thromboembolism in the score CHA2DS2-Vasc . Making the elderly a priority target for the~     prevention of thromboembolism, both because of the increased thromboembolic risk and~     prevalence of AF in this population. For many years, vitamin K antagonists (VKA) have proven~     their effectiveness in this context . But the effectiveness and safety of thromboembolism~     prevention by anti-vitamin K treatment involves maintaining the INR (International~     Normalized Ratio) in the therapeutic range. Indeed occurred of a thromboembolic or~     haemorrhagic adverse event directly correlates to having an INR outside the therapeutic~     range and maintaining the INR in the therapeutic range is subject to many variations inter-~     and intra-individual. They include, genetic factors , food , drug interactions , as well as~     disease processes . Or one of the elderly characteristics is the coexistence of multiple~     pathological processes or comorbidities . The supposed interaction between comorbidities and~     variability of INR has been little studied: Only a few studies have examined the factors~     associated with the stability of the INR and unstable . The identification of patients at~     risk of instability INR yet allow clinicians greater vigilance and better identification of~     patients for whom the initiation of treatment with vitamin K does not appear the best~     therapeutic strategy.~      Our study seeks to determine whether comorbidity, assessed by the Charlson comorbidity~     index, are associated with instability of the INR, among more than 80 years for patients~     treated with AVK atrial fibrillation.~   "
16491|NCT02841462|"~     The overall objective of this trial is to explore the dose-tolerance (safety) and~     dose-response (efficacy) of single 3-minute intra-bursal perfusions of a physiological~     saline solution at increasing temperatures.~   "
16492|NCT02841449|"~     The aim of this study is to investigate whether hydration status affects blood sugar control~     and appetite regulation. In order to do this, participants will undergo a monitoring phase~     whereby their weight, diet and physical activity are monitored, followed by a dehydration~     protocol involving fluid restriction and sitting in a heat tent. In one arm of the trial,~     participants will remain dehydrated for the remainder of the day (i.e. after the heat tent)~     by having their fluid intake restricted, and in the other arm of the trial, participants~     will be rehydrated by consuming the necessary amount of plain water. All participants will~     undergo both arms of the trial, the order of which will be chosen randomly.~      Several measures will be taken throughout the trial. Before participants go into the heat~     tent, they will provide a urine sample (for baseline hydration status as indicated by urine~     osmolality), a blood sample (for glucose, insulin, arginine vasopressin,/copeptin, ghrelin~     and serum osmolality and plasma volume), and have a peripheral quantitative computer~     tomography scan of their thigh to indicate muscle size. On the day proceeding the heat tent,~     participants will have these measures repeated, along with metabolic rate before consuming a~     75 g glucose drink, followed by 15 minutely blood samples and hourly metabolic rate measures~     for 120 minutes (i.e. an oral glucose tolerance test; OGTT). Following this, participants~     will be presented with a large bowl of pasta and sauce and will be instructed to eat until~     satisfied (maximum 30 min). Blood samples will be taken every 10 minutes for 60 minutes~     following the meal.~      Participants also have the option to opt-in to have a muscle biopsy taken. This will be~     taken before and ~120 minutes after the glucose drink.~   "
16493|NCT02841436|"~     Pancreatic cancers is one the most important malignancies with highest mortality in the~     world. The prognosis of these patients is very poor. Although some patients with~     early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of~     patients present with locally advanced or metastatic status are inoperable. Patients in this~     late status usually are recommended to receive palliative bypass operation such as~     choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the~     pancreatic cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy.~     However, the main drawback of RFA is its side effect to damage adjacent structure such as~     bile duct, and the tumors located adjacent to vessels could not be ablated well.~   "
16494|NCT02841423|"~     Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac~     surgery is a common problem.~      Therefore,this study was designed to assess POCD after closed-loop coadministration of~     propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia~     in elderly patients undergoing major noncardiac surgery. Methods: After approval of the~     local ethical committee was obtained, 204 patients (American Society of Anesthesiologists~     physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into~     this pospective randomized monocenter study. Patients received anesthesia 3 days after using~     a neuropsychological test battery.~   "
16495|NCT02841410|"~     This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision~     making when evaluating the healthiness of food products with nutritional information~     displayed either with a Traffic Light system, a colored nutritional label, and a Guideline~     Daily Amount system, a numeric label.~   "
16496|NCT02841397|"~     Noninvasive pulse oximetry-determined SpHb will be compared to ABG co-oximetry and research~     lab equipment-determined Hb values, Oxygen Reserve Index (ORI) will be correlated with paO2~     via ABG, PVI and acoustic waveform data will be compared to the arterial waveform extracted~     SVV or PPV values. The study goal is to establish the correlation of Hb values determined by~     the SpHb system with Hb as measured by other validated devices, use ORI to correlate with~     paO2 in the moderate hyperoxic regions and correlation of PVI with SVV or PPV values.~   "
16497|NCT02841384|"~     Introduction: Patellofemoral pain syndrome (PFPS) is related to the previous sore knee,~     change functionality and postural control deficits. One of the possibilities for pain~     control and better positioning of the patella is the rigid bandage patellar widely used by~     clinicians and researchers.~      Objective: To evaluate the effect of rigid patellar bandage on postural control, pain and~     function in sedentary women with PFPS.~      Methods: The sample will be composed of 30 volunteers, sedentary, between 18 and 55 years;~     randomized group Bandage Functional Rigid (n = 15) and Banding Placebo (n = 15). All fill~     the Personal Data Sheet, Visual analog scale Pain Questionnaire Previous Knee Pain Scale;~     and will be submitted to analysis of postural control (static and dynamic) and carry out the~     test and sit up in pre conditions and post application of the bandage.~      Hypothesis: Expected to observe the effect of rigid patellar bandage in pain, function and~     postural control in sedentary women with PFPS.~   "
16520|NCT02841085|"~     Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or~     identifying genes involved in subjects at high risk for thrombotic and in whom screening for~     detectable hereditary thrombophilia was negative.~   "
16521|NCT02841072|"~     The primary objective of this study is to document the rates of success and serious~     complications among women having outpatient medical abortions with 200 mg mifepristone + 800~     buccal misoprostol at 64-70 days of gestation.~   "
16498|NCT02841371|"~     Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in~     adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate~     (GFR) are the primary means of screening for CKD in epidemiological investigations. However,~     there are many important problems to be solved, whether albuminuria test or GFR evaluation.~     The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months,~     with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein~     excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects~     of different times of screening for CKD and observe the daily physiological variation of~     ACR, PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders,~     in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment~     of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP)~     based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid~     (DTPA) renal clearance method. Then to develop GFR estimation equation based on the~     combination of serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.~   "
16499|NCT02841358|"~     Niemann-Pick disease, Type C is a rare genetic disorder characterized by a failing in~     intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain.~      Neurological signs are at the forefront of the disease. There are also psychiatric signs of~     psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were~     published. These signs can be concomitant with neurological signs or precede them.~      Is is likely that psychotic disorders are the first signs of a Niemann-Pick disease not yet~     non encore diagnosed for some patients. Yet, no prevalence study for this disease in a~     psychiatric population of patients currently exists. In response to this problem this study~     proposes to search patients whose disease could be of organic origin or patients whose~     disease is suspected, based on clinical data. The diagnosis will be confirmed certified with~     a genetic and/or biochemical test.~   "
16500|NCT02841345|"~     In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention~     dysfunction contribute, according to the theories of neuroscience, the development of mood~     disorders following disturbances in the interaction-care emotion. In this context, the~     general objective of this research project is to refine our understanding of the~     similarities and distinctions between bipolar and schizophrenic patients in the basic~     emotional information processing. Specifically, these are: 1) to better understand what~     level of basic emotional information processing both conditions differ or are comparable and~     in what sense and 2) estimate, in both pathologies, the specific influence of the nature of~     the task of processing emotional information. To answer these questions, the investigators~     have developed a protocol to specifically target different information processing channels~     playing on the nature of the spatial frequency content of emotional natural scenes. To~     estimate in both pathologies, the specific influence of the nature of the task on emotional~     processing, 3 types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks~     whose categorization one focused on the emotional feelings of the individual and the other~     on the tendency to action. Both tasks categorization should involve more specifically the~     ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC)~     respectively. All patient data will be compared with data from healthy control participants.~   "
16501|NCT02841332|"~     The purpose of this study is to estimate the capacity of the multimodal imaging parameters~     measured at 15 days and 2 months of initiation of treatment with bevacizumab, to measure~     changes in clinical status (sensitivity to measure changes) in patients treated for~     recurrent glioblastoma.~   "
16502|NCT02841319|"~     The investigators have planned a research on the effects of virtual reality therapy and home~     exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul~     University Istanbul Faculty of Medicine in the Department of Physical Medicine and~     Rehabilitation. The eligible patients will be randomized into two groups. The patients in~     intervention group will participate in a computer based virtual reality exercise program for~     a period of 8 weeks supervised by the investigators. In addition, these patients will~     receive a home exercise program. The patients in the control group will receive only a home~     exercise program for 8 weeks. All patients will be evaluated before treatment, immediately~     after treatment, and 3 months after the end of the treatment.~   "
16503|NCT02841306|"~     20 patients presenting a rhegmatogenous retinal detachment with more than 4 days of duration~     will be prospectively included.~      A single dose of ursodeoxycholic acid will be administered orally before surgery at~     different time-points in 16 subjects. Standard surgery will be performed and ocular samples~     will be collected during the procedure. Ursodeoxycholic acid treatment will be continued in~     treated patients during 3 months after surgery.~      Ocular and serum samples from the 4 untreated patients will serve as negative controls for~     the determination of UDCA levels.~   "
16504|NCT02841293|"~     The originality of the GRECCAR project is to propose a holistic approach of the evaluation~     combining the paradigms of surgical efficacy, costs, quality of life and oncological~     adequacy, reflecting real life.~   "
16505|NCT02841280|"~     It is estimated that in the United States there are approximately 8 million individuals who~     have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and~     is often poorly controlled due to an expanded volume state; diuretics are frequently~     prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but~     their use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are~     less potent, their use may be associated with less acute kidney injury, but as yet there are~     no firm data to support that thiazide diuretic therapy can improve BP among subjects with~     advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in~     advanced CKD either alone or in combination with loop diuretics and concluded that thiazides~     may be useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and~     weight loss by 1-2 kg in observational studies. Observational data show that thiazides lead~     to an improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic~     whereas randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had~     only between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate~     their safety and efficacy in moderate to advanced CKD.~   "
17039|NCT02834312|"~     This dose-finding study is being conducted to select the daily oral dose of estetrol (E4)~     for the treatment of vasomotor symptoms (VMS) in post-menopausal women.~   "
16507|NCT02841254|"~     Meningitis are serious infections. Evidenced by high rates of mortality and sequelae.~     However, these diseases have a relatively small impact. Also physician services Home~     Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis.~     Indeed, it is only after this essential clinical milestone that will be carried out a lumbar~     puncture which will confirm the diagnosis and to quickly begin treatment.~      Unfortunately, if recent studies can improve the therapeutic management of patients with~     meningitis, no study was interested in yet fundamental step of diagnosis.~      It seems therefore necessary to achieve a prospective clinical study to reassess the~     adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve~     a predictive clinical score of the presence or absence of meningitis.~   "
16508|NCT02841241|"~     This is a prospective, single arm, roll-in study of esmolol infusion for patients with~     septic shock with persistent tachycardia after adequate intravenous volume expansion. The~     study will evaluate the adequacy and efficiency of study protocols for the anticipated, main~     ECASSS study, which will have a separate entry in clinicaltrials.gov.~   "
16509|NCT02841228|"~     Lung cancer is one of the most common cancer and the leading causes of cancer death in~     worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with~     LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous~     integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety~     increasing the radiation dose and benefit for inoperable NSCLC patients.~   "
16510|NCT02841215|"~     Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment.~     Ivermectin is a recommended treatment in common forms of scabies and represents a promising~     treatment in crusted scabies in case reports. However, response to ivermectin remains~     variable among studies, and there is no consensus on the schemes to adopt (dosages and~     administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity~     (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg~     ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of~     scabies (crusted and profuse).~   "
16511|NCT02841202|"~     The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula,~     retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT).~     The present clinical study is the first research reported in the literature which is~     investigating the posterior ocular segment changes in women using OCP by using OCT.~   "
16512|NCT02841189|"~     This is a single center trial to evaluate the performance of the King Vision video~     laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the~     performance is satisfactory, this device may become a standard laryngoscope for tracheal~     intubation in elective and emergent tracheal intubations.~   "
16513|NCT02841176|"~     This study will be an open label pilot study to explore the utility of thermography in~     assessing response to Golimumab treatment in Psoriatic Arthritis (PsA). Ten patients~     fulfilling the Classification criteria for Psoriatic Arthritis (CASPAR) for Psoriatic~     Arthritis with active disease and eligible for anti-TNF therapy will be invited to~     participate in this study. They will be assessed at 4 time points during the study: prior to~     their first anti-TNF medication (screening and basal visits), and subsequently within 5 days~     after their 2nd and 4th doses of monthly Golimumab.~   "
16514|NCT02841163|"~     Measurement of herniated disc resorption and assessment of satisfaction regarding~     post-treatment state and integrative Korean medicine treatment through phone interview in~     500 patients with MRI follow-up results receiving treatment for lumbar and cervical disc~     herniation at Jaseng Hospital of Korean Medicine.~   "
16515|NCT02841150|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of~     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.~   "
16516|NCT02841137|"~     This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg~     tablets compared to progesterone 100 mg capsules on the endometrial thickness of~     post-menopausal women under hormone therapy with estradiol.~   "
16517|NCT02841124|"~     The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer~     is a complex process that is always painful for patients, relatives and professionals. For~     more than 10 years, shared decision making has been more and more emphasized. However, few~     data in the literature rely on clinical research. In order to understand their difficulties~     and issues, this study explores the determinants and modalities of DLWT and analyses the~     feasibility of different methods for investigating this decision making process.~   "
16518|NCT02841111|"~     Kidney transplantation is the treatment of choice for ESRD. However, the life expectancy of~     kidney transplant patients is lower than that of the general population. Deaths recipients~     are due mainly to cardiovascular diseases related to a chronic inflammatory state. In~     addition, renal transplant patients frequently have anemia, identified as an independent~     cardiovascular risk factor that can be corrected by blood transfusion.~      But the relationship between transfusion and inflammatory condition are bidirectional. The~     patient's inflammatory condition will sound on the effectiveness of transfusion and~     transfusion could trigger an inflammatory condition. This has been reported with the said~     blood components aged, especially with packed red cells in patients hospitalized in~     intensive care after heavy heart surgery.The main objective of this study is to evaluate the~     impact of early transfusions on the evolution of renal transplantation (ie death, anti-HLA~     immunization, acute rejection, graft loss, delayed graft function, cardiovascular events )~     taking into account in the analysis: patient age at the time of transplantation, the number~     of incompatibility (s) (HLA class I and / or II) between the graft and the patient and sex~     of the recipient.~      This is a multicenter retrospective observational study (descriptive epidemiological~     study).The impact of early transfusions is determined retrospectively over a period of 6~     years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers~     of France met the criteria for inclusion. This cohort represents about 12 000-14 000~     patients~   "
16519|NCT02841098|"~     The purpose of this study is to determine whether carotid surgery combined with optimal~     medical therapy improves long-term survival free of ipsilateral stroke in patients with~     asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when~     compared with optimal medical therapy alone.~   "
16522|NCT02841059|"~     In this prospective, comparative non-randomized multiple teaching hospitals study, the~     investigators try to determine the relationship of total hysterectomy and Taiwanese female~     pelvic floor and sexual function from the view of epidemiology and clinical survey. This is~     an important issue that related to female autonomy, health care resources and even national~     health policy. The study results will help to understand whether there is unnecessary part~     in the current hysterectomy procedures and its potential health hazard.~   "
16523|NCT02841046|"~     To evaluate the application of fluid-infusion therapy with the combination of stroke volume~     variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients~     underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old,~     cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into~     two groups randomly: group C with CI as the primary judgment and group S with the~     combination of SVV and CI as the primary judgment.~   "
16524|NCT02841033|"~     Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once~     weekly for two months, then every 2 weeks for four months, then once each month. Study~     treatment may continue until disease progression, unacceptable toxicity, or decision to~     withdraw from the trial. Disease evaluations will be performed every three months until~     disease progression.~   "
16525|NCT02841020|"~     The purpose of this study is to determine if biopsy for non-neoplastic renal disease for~     patients with a small renal mass results in greater postoperative renal function than the~     current standard of care (no additional biopsy).~   "
16526|NCT02841007|"~     The geko™ device is indicated for the prevention and treatment of oedema. The aim of this~     study is to show that recruiting, and performing study assessments in ankle fracture~     patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible,~     and to obtain data to support the powering of a larger study to demonstrate the~     effectiveness of the geko™ device at reducing length of stay for this population of~     patients. This study will also allow us to assess the acceptability, tolerability and~     compliance of treatment with the geko device.~   "
16527|NCT02840994|"~     The objective of the proposed clinical study is to investigate the safety and tolerability~     of CV301 in combination with OPDIVO® (nivolumab), an anti PD1- inhibitor, compared to~     nivolumab alone in subjects with previously treated non-small cell lung cancer (NSCLC). The~     clinical study is designed to evaluate the possible enhanced antitumor activity of CV301~     with nivolumab compared to nivolumab alone in a setting in which nivolumab is the~     standard-of-care, second-line therapy, for metastatic NSCLC. The rationale for combining~     CV301 with nivolumab is based on the hypothesis that CV301 can induce specific immune~     response in the tumor, and that in combination, nivolumab may augment the T cell-mediated~     immune response generated by CV301 by blocking the inhibitory signal of the PD-1.~      The study will include a Phase 1 dose escalation part to assess the safety and tolerability~     of CV301 alone, prior to moving into the combination with nivolumab (the Phase 1b~     component). The Phase 1 part of the trial will be followed by a Phase 1b component to test~     in a single arm lead-in stage the safety and tolerability of the combination treatment, i.e.~     CV301 plus nivolumab, before expanding the number of patients to be treated in the~     randomized Phase 2 part of the trial. The objective of the Phase 2 is to assess the safety~     and preliminary efficacy of CV301 in combination with nivolumab compared to nivolumab alone~     in subjects with previously treated NSCLC.~   "
16528|NCT02840981|"~     The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary~     characteristics in Mediterranean countries, is associated with high antioxidant capacity~     linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA)~     availability and oxidation in mitochondria, thus reducing the production of the reactive~     oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to~     the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED~     (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On~     the other hand, to allow a more an accurate measurement of the actual macro and~     micronutrient intakes, including dietary anti-oxidant micronutrients, the 7-day food records~     is considered as the gold standard of self-administered food frequency questionnaires.~      Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse~     biological processes, including lipid metabolism, are low in obese patients, as a possible~     attempt to decrease fat oxidative capacity and mitochondrial ROS production, however~     promoting ectopic liver fat storage.~      The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and~     the visceral adiposity index (VAI), a gender-specific mathematical index based on simple~     anthropometric and metabolic parameters, represent well-validated, reliable and widely used~     markers of cellular health and ectopic adipose distribution and function, respectively. The~     fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an~     independent predictor for diabetes mellitus.~      Aim of the present study was to investigate in adult obese individuals the levels of Sirt4~     according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the~     possible association with single dietary components evaluated by 7-day food records, and to~     evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular~     health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.~   "
16529|NCT02840968|"~     In this cross-sectional observational study the investigators evaluated the association~     between the adherence to the MD and PhA in a sample of adult population, stratified~     according to categories of sex, age, and BMI.~   "
16530|NCT02840955|"~     Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis.~     Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100,~     which has the ability to specifically lyse the cell wall of S. aureus. The investigators~     hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently~     decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of~     Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis.~     Secondary goals are to retrieve information about the effect on clinical symptoms, quality~     of life, growth characteristics of Staphylococcus aureus and the further microbiome.~   "
16565|NCT02840500|"~     Patients treated in Palliative Care Units are potentially fragile patients, especially in~     our case, which are cancer patients. The management of these patients is usually done from~     experience, because these patients rarely meet criteria for clinical trials, as their~     inclusion could affect results obtained in the trial.~      There is insufficient clinical information on the quality of life of cancer patients with~     breakthrough pain treated in palliative care units according to routine clinical practice.~     For this reason we consider it is appropriate to prospectively evaluate the quality of life~     of cancer patients with cancer breakthrough pain treated in palliative care units as well as~     the characteristics of these patients.~      This post-authorization observational study will assess the quality of life of patients with~     breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.~   "
16531|NCT02840942|"~     Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized~     children. The placement of IVs requires significant staff time, contributes to health care~     costs, and causes pain and distress in the patients receiving them. Techniques currently~     used at Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase~     success of IV placement center depends on members of the Child Life Department distracting~     patients during insertion. Recent literature has suggested that humanoid robots can be a~     powerful form of distraction and lead to decreased pain during painful procedures in~     children. Work done by the University of Southern California (USC) Interaction Lab has shown~     that socially assistive robots can use techniques more complex than pure distraction to lead~     to a human-robot interaction that is perceived as more positive by the human. The~     investigators propose a project pairing children receiving an IV with either a (1) Child~     Life staff member only (2) pure distraction robot + Child Life or (3) an robot teaching~     coping skills + Child Life with a goal of reduced pain. Pain will be measured by participant~     self-report, family member perceived pain, parasympathetic activation, and pain behaviors as~     measured by video.~   "
16532|NCT02840929|"~     OBJECTIVES: Up to 15% of patients with peptic ulcer bleeding will develop rebleeding, mainly~     in those with ulcers of higher-risk stigmata (i.e. Forrest class Ia to IIb). Randomized~     trials show that second-look endoscopy is effective in reducing rebleeding rate. However,~     whether to withhold aspirin or other anti-platelet agents (for the treatment of established~     cardiovascular or cerebrovascular diseases) remains controversial. Studies have shown that~     although continuation of anti-platelet agents reduces mortality rate due to reduced~     cardiovascular and cerebrovascular events, there is a marginal increase in rebleeding risk.~      HYPOTHESIS: We hypothesize that continuation of aspirin or other anti-platelet agents~     coupled with second-look endoscopy could reduce the rebleeding rate without increasing the~     risk of thromboembolic events in high-risk patients.~   "
16533|NCT02840916|"~     Objective: To determine the therapeutic effect of acupuncture on postpartum weight~     retention.~      Methods: 66 subjects after delivery with postpartum weight retention will be randomly~     divided into laser acupuncture and control group. A single-blind clinical trial will be~     conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions~     per week. After about 3 weeks of treatment, the differences of the subjects' body weight,~     body mass index, and waist circumference will be analyzed with ANOVA between laser~     acupuncture and control group.~   "
16534|NCT02840903|"~     The objective of this study is to evaluate the image quality for different iodine delivery~     rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced~     Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.~   "
16535|NCT02840890|"~     Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide~     (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with~     breast cancer and in adjuvant situation.~      The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for~     breast cancer is associated with several invalidating side effects for the quality of life~     of patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11%~     will present nausea and vomiting of grade 3-4. Current treatments to prevent these~     gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at~     Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in~     gastrointestinal toxicities with preventive treatments, 83% of patients would use~     alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or~     osteopathy.~      Osteopathy is a method of care and unconventional therapeutic approach. In France, the~     professional title of osteopath is recognized. It aims to prevent and treat functional~     disorders, especially those related to adverse effects of treatment. In oncology, this~     discipline may have additional support for the patient by limiting the mechanical and~     physical constraints of sensitive areas to the toxicity of the treatment. In the case of~     gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in~     abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could~     have an interest in the management of gastrointestinal toxicities related to chemotherapy in~     women with breast cancer and in adjuvant treatment situation.~   "
16536|NCT02840877|"~     After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an~     infectious disease globally. Retrospective studies from many countries, including the United~     States and South Africa, have consistently reported that in addition to having a higher~     burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes.~     This prospective study will attempt to clarify both behavioral and biologic causal~     mechanisms underlying the deleterious effects of problem alcohol use on TB treatment~     response.~   "
16537|NCT02840864|"~     Aim of the study is to test whether surgical removal of a tumor under sonographic control as~     compared to conventional method reduces the rate of resections and local relapse~   "
16538|NCT02840851|"~     Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral~     vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young~     women, young men, older women, and older men using Magnetic Resonance (MR) imaging and~     transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.~   "
16539|NCT02840838|"~     We are investigating ways to reduce pain after abdominoplasty. We hypothesize that injection~     of Dysport (botulinum toxin A) into the rectus abdominis, abdominal wall musculature, during~     abdominoplasty will provide a more effective, longer lasting method for pain control than~     standard of care alone (use of Exparel (liposomal bupivacaine) intraoperatively followed by~     PRN narcotics. We will randomize patients to receive either Disport + standard of care or~     saline (placebo) + standard of care and compare post operative pain for the following 2-3~     months.~   "
16574|NCT02840383|"~     Assess the effects of a school-based multi-component intervention on school connectedness,~     school engagement, and developmental assets through a group randomized, participatory trial.~   "
16575|NCT02840370|"~     The purpose of this study is to investigate whether transcranial direct current stimulation~     (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The~     experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham~     tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three~     language production tasks and a nonverbal executive functions task.~   "
16540|NCT02840825|"~     Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a~     significant impact on the neurosensory development of newborns and especially preterm~     infants. HCMV infection may result from maternal-fetal transmission during pregnancy or~     postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm~     infants, the risk of postnatal infection, particularly through breast milk, is much higher~     in this population (prevalence of about 20%). Many learned societies wonder about the~     interest to inactivate HCMV (by freezing or pasteurization) in breast milk in order to~     reduce or eliminate contamination of these children. However, freezing is relatively~     inefficient to reduce contamination and pasteurization drastically alters the nutritional~     quality of the milk. Therefore, a systematic preventive treatment of breast milk for very~     preterm infants is not currently recommended. An alternative approach could consist in~     detecting HCMV in breast milk to target at-risk situations. This detection can be performed~     by PCR but its cost and the time required to obtain the result prohibits its use for a mass~     detection. Currently, viral status of breast milk is not explored in practice and, depending~     on the health centers, breastfeeding is continued as such or milk is systematically~     inactivated.The main objective of VIRUMILK is to study the feasibility of the CMV detection~     in breast milk from lactating mothers with a biochip.The ultimate goal is to prevent~     postnatal HCMV infection of preterm newborns less than 33 weeks.~   "
16541|NCT02840812|"~     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose~     administration study design. Healthy subjects will be matched to severe renal function~     impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as~     parallel control, which matches healthy with normal renal function according to the of~     subjects with impaired renal function as, after enrollment of subjects with severe impaired~     renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and~     control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect~     the blood and urine samples before and after the administration to perform pharmacokinetic~     analysis and safety observation.~   "
16542|NCT02840799|"~     This trial seeks to assess if potassium nitrate (KNO3) therapy improves exercise capacity~     and oxygen uptake in heart failure patients with preserved ejection fraction (HFpEF).~   "
16543|NCT02840786|"~     This is a randomized study comparing stent and plaque excision systems in treatment of~     Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal~     artery)~   "
16544|NCT02840773|"~     The aim of the present study was to determine the levels of sRANKL and OPG as well as their~     relative ratio in PICF surrounding the two different types of implant-abutment connections~     on short implants after a 12-month monitoring period. Additionally, their association with~     clinical findings and microbiological markers in plaque samples were assessed in the present~     study.~   "
16545|NCT02840760|"~     The purpose of this study is to explore the therapeutic effect and mechanism of transcranial~     magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.~   "
16546|NCT02840747|"~     This document is a protocol for a non-interventional human research study in which the~     investigator hopes to better understand the changes that take place in T cells in Cutaneous~     T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the~     collection and storage of tissue samples from patients with CTCL for future research~     studies. Collection and storage of tissue samples from control patients will also be carried~     out.~   "
16547|NCT02840734|"~     This study investigated the immediate effects of Kinesio taping on muscular power, strength,~     endurance, and lower limb fatigue when taping is applied to rectus femoris and around the~     patella of obese adults based on Kinesio taping techniques.~   "
16548|NCT02840721|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     PF-06480605 in subjects with moderate to severe ulcerative colitis.~   "
16549|NCT02840708|"~     Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose~     inhalation.~      Study Design: Pharmacokinetic open study~   "
16550|NCT02840695|"~     Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial~     skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During~     the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been~     successfully introduced to reduce the disease activity. It is unclear whether bDMARD~     treatment had an effect on spinal fracture risk related to AS. This national registry study~     will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort~     of patients with AS.~   "
16551|NCT02840682|"~     The primary objective of this study is to describe mortality of newborns who received basic,~     advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research~     Unit.~   "
16552|NCT02840669|"~     Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in~     the Caucasian population. The main manifestations of FA are progressive sensory and~     cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A~     severe CM affects ~60% of FA patients, mostly young adults, and leads to cardiac failure~     then death. Currently, no therapy can change the course of this severe cardiomyopathy.~      This study is designed to characterize the cardiac manifestations of FA using cardiac~     magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of~     fatigue severity, in the context of the neurological disease.~   "
16553|NCT02840656|"~     In this prospective observational study we aim to determine the prevalence of oropharyngeal~     and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility~     to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to~     determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic~     characteristics of oropharyngeal and rectal of predominant GNB colonization.~   "
16554|NCT02840643|"~     To examine efficacy of combined unimanual and bimanual intensive therapy in children with~     unilateral brain injury. A key question in hemiplegia therapy is whether the affected hand~     should be trained alone or in tandem with the other hand. In constraint-induced movement~     therapy (CIMT), a participant's less-affected upper extremity is restricted with a sling,~     cast, or mitt, while the participant actively uses the affected arm and hand in skill-based~     therapeutic activities. Bimanual therapy, in contrast, engages both hands in therapeutic~     movement. Since constraint and bimanual therapy target different aspects of hand use, they~     could have synergistic effects on hand function when given in combination.~   "
16555|NCT02840630|"~     The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers~     controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the~     non-diabetic group while the diabetic volunteers will be randomised to a diabetic control~     intervention group or a diabetic fish intervention group. Baseline data will be collected~     from all three groups but only diabetic control intervention group and diabetic fish~     intervention group will go through the 16-week study. This will allow the investigators to~     compare the metabolic health across South Asian population in people with and without~     diabetes.~      The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or~     approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control~     intervention group will continue with their habitual diet, while subjects in the diabetic~     fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g~     n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA~     intervention study among South Asian people in the United Kingdom was able to reverse lipid~     abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However,~     the same study also shows that their daily consumption of EPA and DHA is only 68±99 and~     112±171 mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to~     increase compliance.~      Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be~     recruited only to obtain baseline data in order to compare their metabolic profile with that~     of the diabetic volunteers. This will allow us to investigate the link between omega 3~     status and glycaemic control in a South Asian population.~      Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture~     the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other~     key nutrients such as vitamin D, selenium and iodine.~   "
16556|NCT02840617|"~     This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence~     imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the~     ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be~     possible to use fluorescence navigation system in helping prostate biopsy and lymph node~     dissection in the future.~   "
16557|NCT02840604|"~     The management of cancers and their therapeutic guidance was until shortly mostly based on~     histopathological considerations of the tumor. the development of targeted therapies is a~     turning point and keeps increase. These molecules target a specific molecular defect in the~     tumor making it more effective and more specific treatment. But these treatments are only~     effective if the tumor has a specific molecular abnormality that is characterized and known.~      These therapeutic progresses have been made possible through the decoding of the human~     genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of~     therapies targeting a specific molecular abnormality are available in the therapeutic~     arsenal and dozens more are under development in clinical trials Phase 1 to 3.~      In recent years, the democratization of next generation sequencing has opened a new era in~     cancer research but also for molecular diagnostics. Indeed, the enormous sequencing~     capabilities offered by high-throughput sequencing technologies allow analysis in a limited~     time the entire coding sequence of the genome (exome), or even the entire genome of a tumor~     (whole genome sequencing). Thus, the evolution and the development of broadband and~     associated bioinformatics tools for genomics techniques now make it possible to establish~     the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to~     propose and specifically targeted direct therapeutic identified genetic alterations and~     supposedly responsible for tumor development. An analysis of tumor exome by next-generation~     sequencing (NGS) and provides information on genetic modifications of these tumors.~      This study did not aim to evaluate a therapeutic strategy or treatment. The objective of~     this study is to evaluate the clinical benefit of an analysis of exome performed in current~     practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed~     by quantifying the number of patients undergoing therapeutic proposal based on the results~     of the analysis of the profile of the tumor.~   "
16558|NCT02840591|"~     Primary aim of this study is to assess the feasibility of conducting clinical research for~     delirium (confusion due to medical problems) at Clements University Hospital in Dallas,~     Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or~     an over-the-counter supplement called Citicoline are safe and beneficial in delirium.~   "
16559|NCT02840578|"~     Objectives: To examine whether NK cell activity associates with two confirmed risk factors:~     (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for~     potential confounders, including age, gender, body mass index (BMI), personal history of any~     cancer, and family history of cancer. This project is aimed at measuring NK cell activity,~     which may eventually help in reducing false positive rates of LDCT screening, improve early~     detection of lung cancer, and assist in risk assessment in patients with lung cancer. The~     investigators hypothesize that measurement of NK cell activity may be a useful tool for~     assessing changes in immunosurveillance in patients with conditions or diseases where NK~     cell activity has been shown to be reduced, such as lung cancer~   "
16560|NCT02840565|"~     The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple~     rising dose regimens of BIA 5-453.~   "
16561|NCT02840552|"~     The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to~     establish our ability to reproduce results from the literature using FCH-PET/CT as a~     diagnostic and decision making tool in the management in two predefined groups of prostate~     cancer patients, specifically, biochemical recurrence and high risk staging. The primary~     endpoints of the study are the incidence of adverse events (AE) in the study population up~     to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a~     per-patient and per-lesion basis.~   "
16562|NCT02840539|"~     The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone~     are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3~     lines of previous treatment.~   "
16563|NCT02840526|"~     Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative~     pain management after open renal resection surgery.~      Design, setting, participants: It was a prospective, randomised, open label study held in a~     university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were~     scheduled for elective open renal surgery (open nephrectomy or open nephron-sparing surgery)~     and randomised into two groups - group PVB (n=27) and group GEN (n=31).~      Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by~     general anaesthesia. GEN group received standard general anaesthesia. Both groups were~     treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with~     non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS,~     oxycodone requirement in time points, total oxycodone requirement, and sedation levels~     throughout the first 48h. The investigators measured opioid related adverse events 24 and 48~     h postoperatively and patients satisfaction 48h postoperatively.~   "
16564|NCT02840513|"~     This randomized controlled trial is going to evaluate whether an intervention consisting of~     a smartphone application to assist smokers living with HIV to quit in combination with CO~     self-monitoring compared to stop smoking counselling by physicians during usual care results~     in higher self-reported and biochemically verified smoking cessation rates at 6 months.~   "
16576|NCT02840357|"~     The main purpose of this study is to determine the effect of consumption of purple wheat~     anthocyanin-rich products for eight weeks by human participants with an elevated level of~     chronic inflammation, on oxidative stress and inflammatory responses as measured by select~     plasma biomarkers.~   "
17074|NCT02833857|"~     This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in~     pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at~     the end of hemodialysis.~   "
16566|NCT02840487|"~     Background:~      The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash,~     joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were~     reported in babies born to mothers infected with the Zika virus. Rare cases of a severe~     nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some~     people with Zika virus infection. There is currently no cure for or vaccine against the~     infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small~     amount of Zika virus protein. The body may use this to build an immune response.~      Objective:~      To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.~      Eligibility:~      Healthy people ages 18 35~      Design:~      Participants will be screened through a separate protocol with:~        -  Medical history~        -  Physical exam~        -  Lab and urine tests~      Participants will be randomly assigned to 1 of 4 study groups. They will have about 18~     clinic visits over 2 years. Most will occur in the first year, with long-term follow-up~     visits at months 18 and 24. Visits include a physical exam and blood and urine tests.~      Participants will have vaccine injections. A high-pressure device pushes the vaccine through~     the skin and into the muscle of the upper arm. They will have 2-3 injections depending on~     their group.~      Vaccine visits last 4-6 hours. Others last 1-2 hours.~      Participants will keep a diary for 7 days after each injection. They will record their~     temperature and measure any skin changes at the injection site each day.~      Participants might have extra visits and blood tests if they have health changes.~   "
16567|NCT02840474|"~     Background:~      The human body uses antibodies as one way to help fight infection. VRC01LS is an antibody~     directed against the HIV virus. Researchers want to see if it is safe and well tolerated.~     They will study the amount of VRC01LS in the body and how it changes over time. They will~     check to see if people who get VRC01LS develop an immune response to it.~      Objective:~      To see if VRC01LS is safe and well tolerated.~      Eligibility:~      Adults ages 18 70 who are HIV infected but otherwise healthy. Females who are able to get~     pregnant must be willing to use birth control during the study.~      Design:~      Participants will be screened in another protocol.~      Participants will get the study drug one time, by IV infusion. A needle will guide a thin~     tube into a vein. The study drug mixed with salt water will be dripped into the vein over~     about 30 minutes.~      Participants will be monitored for 30 minutes after the infusion.~      Blood samples will be taken at the following times:~      Once before the infusion~      5 times in the 4 hours after the infusion~      1 time 24 hours after infusion. Some participants may have 3 optional blood draws in the~     time period between 4 and 24 hours.~      For 3 days after the infusion, participants will write their temperature and symptoms in a~     diary.~      There will be a total of 23 study visits over 48 weeks. Ten visits will be in the first 4~     weeks. At all visits, participants will answer health questions and give blood samples.~   "
16568|NCT02840461|"~     A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical~     study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis~     Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of~     moderate to severe papulopustular rosacea.~   "
16569|NCT02840448|"~     Background:~      People with Williams Syndrome (WS) and supravalvular aortic stenosis (SVAS) have less~     elasticity in their blood vessels. This is called blood vessel stiffness. Researchers want~     to see if it affects brain development and cognitive abilities.~      Objectives:~      To test if blood vessel stiffness in people with Williams Syndrome and supravalvular aortic~     stenosis affects brain development and cognitive abilities.~      Eligibility:~      People ages 7 85 who have WS or SVAS~      Healthy volunteers ages 7 85~      Design:~      Participants will have 1 visit. All participants will have the same tests.~      Participants will have a physical exam and medical history.~      Participants will give consent for the study team to review their medical records. If the~     participant is a child or an adult with WS, a parent or guardian will give the consent.~      Participants will have pulse wave velocity/pulse wave analysis. They will lie still in a bed~     for up to 30 minutes. Their torso will be measured. A blood pressure cuff will be put on a~     leg while a probe is placed on the neck. A similar test will be performed with the blood~     pressure cuff on the arm.~      Participants will have ultrasounds of the heart and neck. Each will take 45 minutes.~      Participants will have tests of memory, quickness, and attention. These will take about 1~     hour.~      Participants will have an MRI scan. They will lie still for about 45 minutes on a table that~     slides into a machine. The machine is a large tube that takes pictures using magnetic~     signals. Participants with questions or concerns about the scanner can visit a practice~     scanner on the day(s) before the test to familiarize themselves with the machine.~   "
16570|NCT02840435|"~     This study is designed to test the effectiveness of the smoking cessation intervention Sit~     to Quit through a randomized-control trial. This study will compare abstinence outcomes in~     the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit~     Line.~   "
16571|NCT02840422|"~     The reduction of functional limits and disablilities induced by knee osteoarthritis as well~     as improvement of patients quality of life is a public health need registered amongst the~     priorities established by the French law of August 9th 2004 relative to Public Health~     policy. However, the response to this need is not limited to treatment with health products.~      This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of~     life treated by intraarticular injections, eventually for several years, by difference of~     usual clinical trials.~      This open, prospective, multicentric study aims to analyse, in patient care, the impact of~     three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months~     (D180) in the symptomatic treatment of knee osteoarthritis.~   "
16572|NCT02840409|"~     This is an open-label, randomized, multi-center, comparator Phase II trial looking at the~     addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with~     progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of~     initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68~     weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of~     Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered~     every two weeks IV for the initial 24 weeks. Randomization will take place at the time of~     registration taking into account NF1 and BRAF-KIAA1549-fusion status.~   "
16573|NCT02840396|"~     The purpose of this study is to investigate the effects of repetitive transcranial magnetic~     stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.~   "
16577|NCT02840344|"~     This study aims to improve relationship, psychological, and physical adjustment among young~     breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life~     partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet~     the specific needs for young breast cancer survivors and their partners. The intervention~     will be administered in your home by using recorded videos of a trained MBSR instructor.~     Before, during, and after the 8-week intervention, participants will be asked to complete~     surveys.~   "
16578|NCT02840331|"~     The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor~     size, number and location of the combination of photodynamic diagnosis (PDD) and therapy~     (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric~     cancer at 50 adult patients.~   "
16579|NCT02840318|"~     The investigators developed the theory-driven 'Compassion Intervention', an integrated,~     interdisciplinary approach to address existing gaps in end-of-life care for people with~     advanced dementia. The Intervention consists of two core components: facilitation of an~     integrated, multi-disciplinary approach to assessment, treatment and care; and education,~     training and support for formal and informal carers. The intervention is implemented by an~     Interdisciplinary Care Leader. The primary aim is to understand how the Intervention~     operates in two care homes (with nursing support) in two different health and social care~     economies; one in the Camden Commissioning Group and one in the Barnet Commissioning Group,~     both in London, UK. The secondary aim is to collect preliminary outcome data and estimate~     the cost of employing an Interdisciplinary Care Leader to inform further evaluative studies.~     The final aim is to check that the Intervention causes no harm to residents and their family~     carers.~   "
16580|NCT02840305|"~     Using the available data from psychophysics, cellular electrophysiology and functionnal~     neuroanatomy of visual pathway, current models of visual recognition suppose that the~     perception of scenes start with a parallel extraction of differents elementary visual~     characteristics to different spatial frequencies according to a default processing principle~     named : 'coarse-to-fine'.~      According to this principle, the visual scene's analysis would be decomposed in two steps.~     Fisrt, the fast analysis of the global information borne by low frequency of the scene will~     provide an overview of the scene's structure and would enable a first perceptive~     categorisation which would be then refined, approved or denied by the latest analysis of the~     most local, detailed and precise information, carried by the very high spatial frequency of~     the scene.~      The research carried out since several years is preparing a biologically plausible model and~     to find brain bases by different imaging techniques among healthy subjects but also patients~     with a brain lesion and patients with a peripheral lesion.~      The main goal of this Magnetic Resonance Imaging study is to find brain bases of natural~     scenes's visual perception of the natural scenes.~      Three studies in Magnetic Resonance Imaging will be conducted, during which subjects will~     have to categorize pictures of natural scenes filtered in spatial frequencies. The outcome~     of this study will allow to refine models of visual recognition, most of them based on~     analysis of spatial frequencies.~   "
16581|NCT02840292|"~     The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late~     preterm neonates' was done with an objective to determine whether low maternal hemoglobin~     (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age)~     correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm~     Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be~     undertaken to improve their long term outcomes and to generate useful data on a previously~     well recognised but under researched entity.~   "
16582|NCT02840279|"~     This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled,~     multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic~     profile of BPN14770 in healthy young and elderly male and female subjects and to provide a~     preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.~   "
16583|NCT02840266|"~     The purpose of study is to determine the diagnostic value of Hearing test program on smart~     phone for detected patients who has hearing loss.~   "
16584|NCT02840253|"~     Investigators have started an awake spinal anesthesia program in conjunction with pediatric~     surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of~     general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a~     lack of significant hemodynamic changes in neonates and infants following spinal anesthesia;~     however, there are limited data regarding its impact on tissue oxygenation. The goal of the~     current study is to assess changes in tissue and cerebral oxygenation using non-invasive~     near infrared spectroscopy following spinal anesthesia.~   "
16585|NCT02840240|"~     Opioids are effective analgesics, but cause side effects including sedation, respiratory~     depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a~     FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless~     leg syndrome, may decrease your need for narcotics and thus decrease the risk of side~     effects. The investigator hopes this study will determine if gabapentin enacarbil decreases~     opioid consumption and pain after surgery.~      Patients having elective hip and knee surgery will be asked to participate in the study.~     Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or~     Placebo twice per day for 5 days.~      One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg~     twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil~     600mg or placebo 600mg two hours before the surgical procedure. Six hours after the~     completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg.~     If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or~     placebo 600mg pills to take home along with instructions. However, if the patient remains~     hospitalized, on the first day after the surgery, the patient will have pain assessed in the~     morning using a numerical rating score. The patient's quality of recovery will be evaluated~     using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo~     600mg twice a day with meals. The second and third day the patient is in the hospital, the~     patient will have pain assessed in the morning using a numerical rating score and the~     patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals.~     Then, three months after surgery, the patient will receive a phone call to follow-up with~     possible pain or discomfort the patient may be feeling.~   "
16586|NCT02840227|"~     The primary hypothesis is that disease-free survival is improved in patients undergoing~     resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients~     with combined general-epidural anesthesia & analgesia as compared to patients receiving~     general anesthesia and postoperative patient-controlled opioid analgesia. Patients having~     surgery for resection of potentially curable lung cancer will be randomized to combined~     general and epidural anesthesia or general anesthesia with opioid analgesia. The primary~     outcome will be disease-free survival.~   "
16824|NCT02837133|"~     Typically a course of yoga therapy for stress management takes place over a week, however,~     investigators are often asked to provide a single session for workers. The aim of this study~     is to assess the benefits of a single session of an integrated yoga program compared with~     other relaxation techniques for the staff of schools.~   "
16587|NCT02840214|"~     This research project is focusing on changes in mental fatigue due to transcranial direct~     current stimulation (tDCS) in healthy individuals. The study aim is to see if mental fatigue~     can be rescued by administering a safe dose of tDCS. tDCS has been shown to decrease fatigue~     in healthy individuals experiencing extended wakefulness, and the investigators aim to~     investigate if similar results can be found in a fatigue inducing task. This is a~     single-blind randomized control trial that will compare mental fatigue between tDCS~     treatment and sham treatment groups through both subjective and objective measures.~     Objective fatigue will be measured by reaction time with the Stroop test and subjective~     fatigue will be measured by the multidimensional fatigue inventory questionnaire.~   "
16588|NCT02840201|"~     This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed~     to validate biomarkers in subclinical atrial fibrillation and to determine if the~     prospective biomarker will be informative of the potential efficacy of treatment.~   "
16589|NCT02840188|"~     The aim of this project is to evaluate retrospectively goalkeeper's fractures in children~     using the children fracture classification and to evaluate the distal radius tilt angle of~     the growth plate on plain radiographs of the forearm.~      Patients positive for goalkeeper's fracture will prospectively answer a questionnaire~     concerning risk factors and circumstances during the injury.~   "
16590|NCT02840175|"~     As biologic treatments are expensive and associated with some concerns regarding long-term~     safety, investigator hypothesize that early tapering and then withdrawal of biological~     agent, in an homogenous group of children with juvenile idiopathic arthritis achieving~     inactive disease, is safe and not inferior to the maintenance of stable treatment intensity~     over 24 weeks. In addition, investigator also hypothesize that an earlier tapering of~     treatment is associated with a better quality-of-life and a general cost saving effect.~     MRP8/14 will be studied as a potential biomarker for the risk of relapse. A study for~     biologic agent, anti-biologic agent antibodies and a pharmacogenomic approach will complete~     the research, as pharmacokinetic study during withdrawal of biologic treatment are rare in~     children.~   "
16591|NCT02840162|"~     This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2)~     inhibition suggested by preclinical systems occur in human prostate cancer. To answer this~     question, men who have chosen prostatectomy will be randomly assigned to preoperative~     treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant,~     and benign prostate tissue will then be examined for apoptosis, androgen receptor and~     prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment~     effects. The data generated by this study will serve as a foundation for the development of~     COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger~     scale clinical trials aimed at treatment and prevention of prostate cancer, and will~     validate current preclinical models used to study COX-2 in prostate cancer.~   "
16592|NCT02840149|"~     Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine~     scan. This technology allows precise and early cancer to be visualized and measured on whole~     body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular~     imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTANOC is a~     nuclear medicine imaging agent that is not yet approved by Health Canada but used~     extensively throughout the world. The Ki-67 index, a marker of cell proliferation in NETs,~     is one of the most important prognostic factors in this disease. The objective of this study~     is to evaluate if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely~     correlates with Ki-67 score on initial biopsy. If this hypothesized correlation between SUV~     and Ki-67 score is reproduced, then DOTANOC would serve as a non-invasive method to assess~     cellular proliferation and therefore prognosis of these patients.~   "
16593|NCT02840136|"~     In this trial, various factors that may influence the antibiotic concentrations measured in~     the sputum of cystic fibrosis patients are studied.~      A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as~     hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this~     dilution is unknown and will be determined by comparing sputum samples collected before and~     after the use of an aerosol.~      A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple~     aliquots of the same sputum sample will be compared.~      A third factor is the variability between several sputum samples collected during a drainage~     session. The antibiotic concentrations in 3 separate sputum samples will be compared.~      The final goal is to standardise the sputum sample collection and processing of the samples~     to ensure a accurate concentration measurements in sputum.~   "
16594|NCT02840123|"~     The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG)~     treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines~      Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal~     Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response~     generated in peripheral blood and CSF Assess overall survival and progression free survival~     Correlate the neuroradiological changes with the clinical course and immune response~     generated in peripheral blood and CSF Quality of life evaluation~   "
16595|NCT02840110|"~     Subjects treated with ACTR087 may participate in this long-term follow-up study after the~     completion of the final scheduled visit in the parent clinical study or other~     investigational setting, such as compassionate use, named patient IND, expanded access~     program, or equivalent setting. No investigational product or treatment will be administered~     in this study. These subjects will be followed for safety monitoring on a schedule of~     decreasing frequency through 15 years post-ACTR087 treatment, in accordance with US FDA~     Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving~     recombinant DNA-containing investigational products.~   "
16596|NCT02840097|"~     Trauma is the leading cause of death and disability in children in the United States. The~     long-term goal of this project is to evaluate the benefits and harms of tranexamic acid~     (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot~     study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured~     children.~   "
16773|NCT02837796|"~     The investigators think that the two techniques of TOT (inside-out and outside-in)~     procedures both statistically improve the sexual functions, psychosocial state and quality~     of life after the surgery. Additionally postoperative physical and behavioral-emotional~     scores in PISQ-12 were statistically more increase in inside-out group than the outside-in~     group.~   "
16597|NCT02840084|"~     Purpose: The purpose of this investigation is to test the safety and effectiveness of the~     Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic~     treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation~     Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen~     System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective~     in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic~     breast augmentation patients, maintained at one year from the final treatment. Potential~     benefits of the study to subjects include improvement in the grade of capsular contracture~     of the breast without surgical treatment. The investigation is planned to last 12 months.~   "
16598|NCT02840071|"~     Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer~     Experiencing Psychological Distress.~      Head and neck cancer (HNC) patients are particularly vulnerable to experiencing~     psychological distress . The current guidelines from the National Institute of Health and~     Care Excellence are that cognitive-behavioural therapy (CBT) is to be offered to adults with~     a long-term physical health condition experiencing anxiety and depression. CBT has been~     shown to have several inadequacies for individuals with physical health conditions such as~     cancer. Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming~     to change a person's interaction with their thoughts rather than suppress or alter thought~     content. Although studies indicate encouraging findings for the effectiveness of ACT for~     individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and~     there is a need to evaluate the replicability of ACT effects in people living with HNC,~     given the unique challenges inherent to the disease and its treatment.~      This study aims to inform clinical practise by using a hermeneutic single-case efficacy~     design (HSCED) to answer the following questions:~        1. Is there evidence of psychological change after the introduction of the ACT~          intervention?~        2. If present, are the changes attributable to (a) ACT components, (b) common factors,~          and/or (c) non-therapeutic factors?~      The study will involve recruiting three adults with HNC from specialist HNC psychology~     services. Each participant will have six individual sessions of ACT and complete various~     process and outcome questionnaires during sessions. Following the intervention, participants~     will have a semi-structured interview where their views of the therapy and any changes made~     will be explored. Two outcome measures will be posted to participants at 1-month and 3-month~     post intervention.~   "
16599|NCT02840058|"~     Recent scientific advances have shown the important role of immune system against cancer.~     Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment~     and generate durable clinical responses in some patients. The development of tools for~     monitoring anti-tumor immune responses dynamically is a major challenge to predict the~     effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.~      Thus, the objective of our study is to analyse the interest of the monitoring of~     anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy,~     using an immunoassay developed by our group.~   "
16600|NCT02840045|"~     The purpose of this study is to use a new method to differentiate mnesic abilities of early~     alzheimer patients and patients with a depressive disorder.~      This method is based on the recording of cerebral activity while patients listen to~     familiar, unfamiliar and newly-learned music.~   "
16601|NCT02840032|"~     Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in~     lung transplant patients~   "
16602|NCT02840019|"~     The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing~     MRI coils specifically for pregnant women and testing recently developed MRI image~     acquisition techniques. The investigators aim to more reliably obtain higher quality fetal~     MRI images when compared to current clinical fetal MRI.~   "
16603|NCT02840006|"~     CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide~     a number of conditions that exceed the limits of cardiovascular stability, myocardial~     protection and other organs. Moreover, the combination of general anesthesia and spinal~     anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The~     goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative~     in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal~     anesthesia associated with general anesthesia.~      METHODS: Clinical, prospective, randomized and double covered study, approved by the~     Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing~     the Terms of consent, were randomized and divided into two groups: GI - General and GII -~     General + subarachnoid. General anesthesia was induced according to the weight of each~     patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20~     mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in~     cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study~     was performed using the Mann-Whitney test; the level of statistical significance was set at~     5%.~   "
16604|NCT02839993|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
16605|NCT02839980|"~     In this prospective observational multicenter study we aim to determine the prevalence of~     oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized~     subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in~     surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery)~     and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of~     such colonization in a 10-day timeframe; determine the phylogentic characteristics of E.~     coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E.~     coli isolates; to compare the phylogentic characteristics of colonization and potential E.~     coli infection isolates; to compare the rectal and oropharyngeal colonization composition;~     description of oropharyngeal microbiote~   "
16618|NCT02839811|"~     The COBIOPHAD project targets the development of a highly sensitive, selective, and~     multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address~     the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a~     retrospective study, BLC structures involved in drug hypersensitivity will be identified~     from sera of allergic patients (versus controls) and coupled on the device.~      A prospective study will be performed for the recruitment of samples corresponding to~     patients with known IgE hypersensitivity to BLCs based on results from allergy tests and~     clinical history. Controls will include: non-allergic individuals with known tolerance to~     betalactams. The samples will be used for the validation of the COBIOPHAD device in real~     settings.~   "
16619|NCT02839798|"~     This study is designed to evaluate the safety and preliminary efficacy of synchronized~     transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device~     (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an~     open label study in which subjects will receive treatment 5 days per week for 6 weeks.~   "
16606|NCT02839967|"~     According to the International Association for the Study of Pain (IASP), the~     temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of~     orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular~     joints. Pain is considered one of the most common and limiting clinical manifestations. One~     of the most used resources to treat muscle pain is the low-level laser therapy (LLLT),~     However, the mechanisms responsible for the effects observed in clinical trials remain~     poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has~     some advantages, among them the larger area radiation point and low cost. However, its~     effects remain elusive in intraoral application in temporal muscle, lateral and medial~     pterygoid muscle. Assuming that there is need to investigate therapeutic resources that~     combine not only different wavelengths as well as different light sources (LED and LLLT),~     this study aims to evaluate the effect of phototherapy with a combination of different light~     sources on pain, joint mobility, equity and quality of jaw movements after treatment in~     patients with TMD. It will be made a randomized, placebo-controlled and double-blind~     clinical trial. Individuals participate with myogenic temporomandibular disorder, being~     allocated into 2 groups randomly and stratified by the method of sealed envelopes. The~     results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and~     kinematics. The protocols will be used in a 6 sessions and will be evaluated in four~     different moments. The analyses of the data will be performed by adopting a significance~     level of 5%.~   "
16607|NCT02839954|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell~     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.~   "
16608|NCT02839941|"~     The objective of the study is to evaluate the effect of iguratimod concomitant with~     conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly~     mismatched Kidney Transplant recipients.~   "
16609|NCT02839928|"~     Nasal Ketamine has previously been tested in children for deep sedation or preoperative~     anxiolysis. The investigators intend to test the efficacy of low dose nasal Ketamine in~     children undergoing minor procedures in the emergency department.~   "
16610|NCT02839915|"~     The purpose of this study is to determine the effectiveness of folinic acid in the treatment~     of language problems in children with autism spectrum disorder. Folinic acid, also known as~     leucovorin, is approved by the U.S. Food and Drug Administration (FDA) to decrease side~     effects during cancer chemotherapy. Folinic acid may be helpful in treating language~     problems in children with autism spectrum disorder, but this is not known. Therefore,~     folinic acid is an investigational new drug for this study.Investigators will enroll up to~     60 participants in this study at the Marcus Autism Center over 5 years and a total of 160~     participants across all three centers. Participation will last between 12 - 24 weeks~   "
16611|NCT02839902|"~     The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid~     ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients~     receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group~     of patients not treated with omega-3-acid ethyl esters.~   "
16612|NCT02839889|"~     The purpose of this study is to determine if naloxegol can be used in the treatment of~     opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of~     a two week randomized double blind period followed by a two week open-label period.~   "
16613|NCT02839876|"~     The purpose of this study is to determine if intravenous acetaminophen is superior to oral~     acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.~   "
16614|NCT02839863|"~     Due to better treatment options and earlier detection, survival rates of patients with~     breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality~     of life and the cosmetic outcome are becoming more important. Also, many competing~     experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are~     being developed, all in need to be properly evaluated before being implemented in routine~     clinical care. Randomized Controlled Trials are the gold standard to do so, but they have~     shown many challenges, especially when applied in a cancer setting. The 'cohort multiple~     Randomized Controlled Trial (cmRCT)' design is a promising design for multiple~     (simultaneous) randomized evaluations of experimental interventions, with potential for~     increased recruitment, comparability and long-term outcomes as a standard.~      By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the~     investigators aim to:~        -  provide an infrastructure for efficient, fast and pragmatic evaluation and~          implementation of experimental interventions~        -  gain insight into short and long-term treatment response, toxicity, complications,~          quality of life and survival of patients with breast cancer.~   "
16615|NCT02839850|"~     The primary objective of this study is to examine the change from pre-operative baseline to~     two year postoperative functional performance improvement for the ATTUNE primary, cementless~     TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be~     carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless~     CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).~   "
16616|NCT02839837|"~     Depression is associated with a disruption in the mechanisms that regulate neuroplasticity.~     Effective treatment and rehabilitation of depression, and other neurological and~     neuropsychiatric disorders, relies on neuroplasticity. Thus, identifying therapies that~     enhance neuroplasticity (neuroplastic adaptation) are vital in the comprehensive treatment~     of depression. Aerobic exercise training has been demonstrated to have antidepressant~     properties and single bouts of aerobic exercise may provide short-term improvements in~     affective states in depression. Furthermore, acute aerobic exercise may enhance the response~     to known neuroplasticity-inducing paradigms. However, it is unclear if aerobic exercise can~     influence neuroplasticity in depression and the neurobiological mechanisms underlying acute~     neuroplastic changes are not well understood in depressed and healthy cohorts. Thus, the~     purpose of this project is to examine the acute effects of aerobic exercise on neuroplastic,~     neurobiological, and mood indices of depression.~   "
16617|NCT02839824|"~     Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient~     adherence to investigational products increases in the context of clinical trials. By the~     same token, efficacy of interventions may be overestimated in clinical trials.~      For this reason, an observational study to collect data on the effectiveness of several~     colonic preparations when these are used under usual clinical practice is proposed.~   "
16620|NCT02839785|"~     SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8~     and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence~     of pain in these populations was respectively 60 and 69% while it is about 35% in typically~     developed children of the same age.~      The main location of the pain for 60% of children with CP was the lower limbs, caused by~     musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE~     2, 50% of the children complained about pain during physical therapy.~      If the pain is part of the management of physiotherapy, a recent review showed that for a~     condition such as chronic back pain, the level of evidence of the effectiveness of~     physiotherapy techniques in reducing pain is low. The effectiveness of these techniques~     would include higher efficacy on anxiety than pain itself.~      Despite significant involvement of physiotherapists in the management of pain, the focus on~     pain should increase, in particular taking into account the procedural/induced pain (caused~     by treatment).~      In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to~     reduce the pain of children during medical procedures. For the latter most of them require~     the presence of two individuals to provide the therapy. This is unsuited for out-patient~     care provided to the majority of children with CP.~      Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination~     with the treatment of several indications in child pain (migraine, postoperative pain,~     etc.). Ibuprofen is commonly used in children during painful procedures and represented the~     4th molecule among prescribed per os analgesic drugs in 2008 in the United States.~   "
16621|NCT02839772|"~     An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a~     research based skin management regimen compared to the current regimen. The experimental~     group added 2% glycerine to the current skin care regimen and used 1 litre of water in the~     water soak compared to the 6 litres used in the current regimen.~   "
16622|NCT02839759|"~     This RCT will have two arms: A control group that receives the standard of care from~     audiologists and an experimental group that receives both the standard of care and the~     at-home use of the TELLYHealth intervention. Subjects in each group will complete~     questionnaires at enrollment, mid-study and at the end of the study.~   "
16623|NCT02839746|"~     Describe patient and physician assessed factors for patient well-being when treated with~     Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to~     previous antithrombotic treatment (switcher)~   "
16624|NCT02839733|"~     Background:~      Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter~     dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in~     motor skill learning. Genes that relate to DA function may affect a person s ability to~     learn new cognitive or motor skills. Some children with CP can learn motor skills easily~     while others have trouble. Researchers want to find out if DA gene variations cause some of~     this variability.~      Objectives:~      To learn more about how DA and its related genes affect motor and cognitive learning in~     people with and without CP.~      Eligibility:~      People ages 5 25 with and without CP who can:~      Follow the protocol~      Attend and perform the training sessions~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood draw for genetic tests~      The study has 2 parts. Participants with CP can join both. Those without can join only Part~     1.~      All participants will have a baseline assessment: short motor skills test and blood draw.~      Part 1:~      Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the~     clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor~     training sessions are at the clinic. Participants will step on lines in a virtual reality~     environment.~      Part 2:~      Two lab training sessions at least 1 week apart. Participants will perform tasks on a~      computer.~      Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides~     into a machine that takes pictures. They will be in the scanner about 45 minutes. They may~     have a~   "
16625|NCT02839720|"~     This pilot clinical trial studies how well selumetinib works in treating patients with~     neurofibromatosis type 1 and dermal neurofibromas. Selumetinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
16626|NCT02839707|"~     This randomized phase II/III trial studies how well pegylated liposomal doxorubicin~     hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian,~     fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy,~     such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. block tumor growth Monoclonal antibodies, such as atezolizumab~     and bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not~     yet known which combination will work better in treating patients with ovarian, fallopian~     tube, or primary peritoneal cancer.~   "
16627|NCT02839694|"~     Background:~      Most patients who have surgery for cancer that has metastasized (spread) to the lungs later~     get more metastases that cannot be treated with surgery or chemotherapy. The drug resistance~     may be due to DNA changes in cancer cells that activate some genes and turn others off.~     Researchers want to test a combination of drugs for people with metasteses. Decitabine (DAC)~     may reverse the DNA changes. Tetrahydrouridine (THU) makes DAC last longer. Celecoxib may~     slow the progression of cancer.~      Objectives:~      To determine a safe dose of DAC and THU by mouth. To see if DAC-THU with or without~     celecoxib reactivates genes in lung metastases.~      Eligibility:~      Adults 18 years and older, with cancer in both lungs that can be treated with surgery.~      Design:~      Participants will be screened with:~      Blood, lung, and heart tests~      Scans~      Tests for viruses~      Pregnancy test~      Participants will have blood and stool tests.~      They will have surgery to remove metasteses in 1 lung.~      About 3 weeks later, they will have lung scans. If the disease is not back, participants~     will get DAC and THU with or without celecoxib, by mouth for 6 weeks.~      Participants will have more scans. If the disease is not worse, they will continue the study~     drugs for 4 more weeks.~      Participants will have more scans and heart and lung tests. They will have surgery to remove~     metasteses from the other lung.~      Participants will have weekly blood and urine tests, plus several blood draws the first 2~     days of taking the drugs.~      Participants will have exams and blood tests before each surgery.~      Participants will have follow-up visits 1 and 3 months after the second surgery.~   "
16628|NCT02839681|"~     Background:~      Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a~     protein on the surface of tumor cells in many types of tumors, including most lung cancers.~     Researchers want to find a safe dose for the study drug for lung cancer. They want to see if~     it can shrink tumors in mesothelin-positive lung cancer.~      Objectives:~      To test the safety and effectiveness of anetumab ravtansine for lung cancer.~      Eligibility:~      Adults 18 years and older who have lung cancer that has gotten worse on other therapy~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Tumor tissue sample. This can be from a previous procedure.~      Blood and urine tests~      Heart tests~      Scans. For one scan, a small amount of radioactive substance is injected into the blood.~      Eye exam~      The study will have 21-day cycles.~      On day 1 of each cycle, participants will get the study drug through a tube inserted in a~     vein.~      Participants will repeat a heart test in cycles 1 and 2.~      They will have blood tests weekly in cycle 1, twice in all other cycles.~      They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of~     year 2, then every 12 weeks.~      Participants will have samples of tumor tissue taken twice.~      About 30 days after stopping the study drug, participants will have a follow-up visit. This~     will include medical history, physical exam, blood and pregnancy tests, and heart and eye~     tests.~      Some will be called a few times a year to discuss their health and treatment.~   "
16629|NCT02839668|"~     Because neoplastic disease is one of the leading causes of death worldwide and breast cancer~     is one of the most frequent neoplasia among women, the possibility of influencing the~     evolution of patients starting from the moment of surgical intervention using a~     perianesthesic intervention is a scientific topic of high interest. The study will compare~     two anesthetic techniques and their efficiency in lowering the factors that can favorize the~     dissemination of neoplasia and their role in the prevention of postoperative pain. The serum~     level of vascular endothelial growth factor A (VEGF-A) will be determined before and after~     the surgical intervention after using two different types of anesthesia (inhalational and~     intravenous), and the immunohistochemical expression of vascular endothelial growth factor~     receptors (VEGFR) will be determined on the excised tissue. For the two different types of~     anesthesia a continuous infusion of lidocaine 1% will be associated. The study will compare~     the short-term and long term-outcome of the patients assigned the two different types of~     anesthesia and their immediate postoperative evolution .~   "
16630|NCT02839655|"~     The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in~     Asia and begins to spread in Western countries. The main advantage of the technique is to~     avoid a scar in the neck by placing it either in the axilla or at the hairline behind the~     ear to improve esthetic consequences and body image. It is not surgery minimally invasive~     but rather a way of remote access surgery.~      Data from the literature including cohort studies and meta-analyzes attest the security of~     the procedure in comparison with classic thyroid surgery (which remains the gold~     standard). However there is few data on the effectiveness of the technique in terms of the~     completeness of the surgery, according to the routine standard criteria used in~     endocrinology and endocrine cancer, and no French medico-economic study has been performed.~   "
16631|NCT02839642|"~     Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the~     parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and~     affects 3,000 to 10,000 persons in France. PSP is characterised by a doparesistant~     parkinsonism with axial signs such as early gait instability and falls, oculomotor signs~     such as a vertical gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural~     disturbances. The latter predominantly manifest as psycho-motor slowness, apathy and frontal~     executive deficits. Swallowing impairments and falls may lead to life-threatening situations~     and death occurs 6-9 years after disease onset.~      Apart from L-dopa which may transiently and inconsistently improve motor symptoms no~     effective symptomatic, disease-modifying or neuroprotective therapy is presently available~     to reduce disability in any way. Therefore these patients often receive mostly non-medical~     care such as physiotherapy and speech therapy.~      In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP~     correlated with gait and balance impairments . This stands in contrast with the limited~     number of studies of cholinergic augmentation strategies in PSP.~      Trials of cholinesterase inhibitors in PSP have produced rather conflicting results:~     donepezil improves cognition but deteriorates some motor functions whereas a case series of~     5 PSP patients treated with rivastigmine found an improvement in several cognitive aspects~     and no deterioration of motor functions .On the other hand in Parkinson's disease there is~     convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls~     Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase~     inhibitor) may reduce gait and postural impairment in PSP and may therefore limit the number~     of falls and their consequences both in terms of injuries sustained (fractures etc...) and~     on the patients' autonomy. In addition investigators hypothesise that rivastigmine may also~     reduce the cognitive and behavioural impairment associated with PSP. Taken together these~     improvements are likely to produce a significant effect on the patients' quality of life and~     their caregiver burden.~   "
16632|NCT02839629|"~     A study to describe and evaluate patient characteristics and clinical outcomes in Subjects~     with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.~   "
16633|NCT02839616|"~     The Institutional Registry of Liver Transplantation is a system for data collection related~     to patients with liver disease who are possible candidates for liver transplantion. This~     tool was designed by a multidisciplinary team that includes hepatologists, surgeons,~     informatics and biostatisticians. It intends to collect the information from the clinical~     evaluation, physical examination, complementary diagnostic methods and laboratory data. The~     information is captured sistematically, following structured, standardized and monitored~     processess to ensure the quality of the data obtained.~      The aim is to use the available technology to generate a complete database that can be used~     to answer research questions.~   "
16634|NCT02839603|"~     To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani~     infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to~     inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV~     co-infected individuals in East-Africa (Ethiopia).~   "
16635|NCT02839590|"~     There are currently many surgical options for patients with glaucoma and ocular hypertension~     (OHT), including the Hydrus Microstent implant, HiFU (High intensity Focused ultrasound),~     STAR flo, Kahook Dual Blade, Diode laser, trabeculectomy and the Baerveldt implant, but~     little is known about how these different surgical techniques used to treat glaucoma affect~     the flow of fluid through and out of the eye (aqueous dynamics).~   "
16774|NCT02837783|"~     The objective of this trial is to determine the effect of linaclotide on abdominal girth in~     irritable bowel syndrome with constipation (IBS-C) participants with the baseline symptoms~     of abdominal bloating and an increased abdominal girth.~   "
16636|NCT02839577|"~     The aim of the study is to determine the effect of steroid in High Volume Injection (HVI)~     compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon~     thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).~      Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls~     0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI~     without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).~      All subjects will perform a 12-wk eccentric training program with further eccentric training~     3 times per week from week 12 to week 24.~      Clinical examinations and ultrasound will be performed at baseline (before treatment) with~     follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any~     possible changes and differences between the two groups.~   "
16637|NCT02839564|"~     Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term~     effects are not known. The objective was to to evaluate long term effects of laparoscopic~     adhesiolysis for treating chronic abdominal pain.~      Therefore one hundred patients with abdominal pain attributed to adhesions were randomized~     to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was~     assessed after 3, 6 and 12 months and 12-year follow-up.~   "
16638|NCT02839551|"~     Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and~     in the absence of contraindications), but there are no standardized protocols and most~     groups use hypothesis (clinically-driven) protocols.~      investigators used 20 year experience in drug hypersensitivity to analyse retrospectively~     171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis,~     they identified optimal doses to include in a data-driven protocol. This data-driven~     protocol will be applied to new prospective patients, to test its safety and benefits (gain~     in time, hospital and patient benefits).~   "
16639|NCT02839538|"~     Background and Objectives: Postoperative analgesia and early recovery are relevant for~     hospital discharge after hemorrhoidectomy. This study investigated the postoperative~     analgesic effect with local infiltration compared with spinal block.~      Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group~     (LG) received local infiltration under general anaesthesia; spinal group (SG) received a~     subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol~     infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of~     0.5% hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and~     1% lidocaine for SG. There were assessed: postoperative pain intensity, sphincter~     relaxation, motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and~     adverse effects.~   "
16640|NCT02839525|"~     The study is a randomized, double-blinded, placebo-controlled trial that will include the~     participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional~     strategies that help to minimize the effects of muscle damage induced by exercise.~      The procedures will be performed at the Federal University of Health of Porto Alegre~     (UFCSPA).~   "
16641|NCT02839512|"~     This is a single center study to assess metabolic effects in subjects after a Jejunal to~     Ileal Diversion procedure was performed using colonoscopes.~   "
16642|NCT02839499|"~     Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over~     60 years with major consequences especially on the cardiovascular system.~      This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved~     in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet,~     logically leading to atrophy of the muscles aerodigestive crossroads.~      Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the~     individual to a higher risk of apnea and hypopnea during sleep.~      The objective of this study is to determine if there is a significant increase in the~     prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term~     care units, receiving a mixed food compared to residents in supply to normal texture.~   "
16643|NCT02839486|"~     The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during~     elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata:~     neonates, infants, children weighting less than 40 kg and children weighting more than 40~     kg.~   "
16644|NCT02839473|"~     The primary objective consisted of avoiding deterioration and/or restoring the integrity of~     the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2~     radiation dermatitis.~   "
16645|NCT02839460|"~     This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and~     expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well~     as healthy, physically active controls.~   "
16646|NCT02839447|"~     The purpose of this study is to determine if elevations in oxidative stress, as measured by~     oxidation-reduction potential (ORP), can distinguish between semen samples from men with~     abnormal semen parameters from those with normal semen parameters. Static ORP (sORP)~     results, measured by the MiOXSYS System- a novel technology, will be compared to the current~     World Health Organization (WHO) semen analysis parameters (5th Edition WHO Laboratory Manual~     for the Examination and Processing of Human Semen [2010]).~   "
16647|NCT02839434|"~     Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive~     cardiac procedures .~      Additional parenteral anticoagulation is necessary for these procedures (FA ablation and~     invasive coronary explorations).~      The unfractionated heparin doses are adapted on a monitoring test heparin, activated~     clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This~     goal is the same whether the patient is on oral anticoagulant treatment or not, and~     regardless of the initial level of anticoagulation.~      The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well~     documented, but few data have been published on the effects of heparin monitoring tests,~     particularly on the ACT.~      The aim of this stuy is to redefine the target values of ACT and unfractionated heparin~     doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.~   "
16775|NCT02837770|"~     The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac~     Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain~     related to intravitreal injections will be evalutated.~      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.~   "
16648|NCT02839421|"~     The aim of the present study is to evaluate the clinical and microbiological efficacy of~     moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in~     treating generalized aggressive periodontitis. Forty five subjects will be randomly~     allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable~     bacteria. The primary outcome variable to determine the superiority of one treatment over~     the others would be differences between groups for means CAL changes at 6 months~     post-treatment. Secondary outcome variables include differences between therapies for the~     mean changes in the mean levels of PD and the proportion of BOP.~   "
16649|NCT02839408|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an~     adjunct to scaling and root planning (SRP).~      Material and methods: Fifty-four chronic periodontitis patients will be recruited and~     monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12~     months after therapy. All patients will receive scaling and root planning and randomly will~     be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental~     (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used~     once per day during 3 months. Antibiotic will be used once per day during 5 days.~   "
16650|NCT02839395|"~     The human eye has a dual role, which is reflected by the various photo-receptors used for~     vision of images and colors ,Image forming photoreceptors (IFP) and for entrainment of our~     Biological clock located in the hypothalamus through the retinal ganglions known as~     non-image forming photoreceptors (NIFP). The recently discovered new photo-pigment~     melanopsin which is sensitive to short wavelength (SWL) illumination exists in the-NIFP. The~     axons of the NIFP form a special nerve known as the Retino-hypothalamic-tract (RHT) that~     transfers the SWL signal to the biological clock resulting in suppression of pineal~     melatonin (MLT) production. This is the basic mechanism by which environmental light/dark~     cycles entrain the biological clock and transfer the message to organs, tissues and cell.~      The American Medical Association (AMA) issued a resolution in 2012 stating that light at~     night constitutes environmental pollution because it violates the daily cycles, including~     the waking and sleeping cycles, and suppresses the secretion of melatonin from the pineal~     gland at night. Results of other studies have shown that exposure to artificial light at~     night (ALAN) and mainly those emerging from SWL sources suppresses MLT-produced in the~     pineal gland. Computers, tablets, TVs, and smart-phones screens emit SWL illumination,~     during the day and night hours, whether as active or passive users. The results of previous~     studies show that, exposure to SWL-ALAN illumination suppresses MLT-secretion and disrupts~     sleep patterns. In order to understand better the effect of SWL-exposure emerging from~     screens on human behavior and health, the investigators will study the effects of~     SWL-exposure on the structure and quality of sleep, cognitive functioning in Continous~     Performance Test (CPT III), emotional state, and physiological, variables (melatonin~     secretion levels and body temperature) that were not tested in previous studies.~   "
16651|NCT02839382|"~     The purpose of this project is to build capacity for quality improvement (QI) in small~     primary care practices across Washington, Oregon and Idaho by improving risk factors for~     heart attacks such as blood pressure, cholesterol and smoking. The Northwest Coalition for~     Primary Care Practice Support will assist practices by providing them with a QI coach,~     creating group learning opportunities, and conducting educational outreach activities. An~     innovative study design will be used to determine what levels and types of support are most~     helpful and effective.~   "
16652|NCT02839369|"~     The goal of the present study was to look at the effect of changing walking parameters on~     the dynamic walking characteristics among children post severe traumatic brain injury,~     children with cerebral palsy and typically developed controls.~   "
16653|NCT02839356|"~     Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a~     well-recognized complication with significant morbidity and even mortality. A variety of~     possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary~     edema caused by manipulations during cannulation or endoscopic treatment has received the~     most attention. The papillary edema may cause temporary outflow obstruction of pancreatic~     juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis.~     Topical application of epinephrine on the papilla may reduce papillary edema. Moreover, it~     is reported that epinephrine sprayed on the papilla may be effective to prevent PEP.~     However, it is still unclear that epinephrine sprayed on the papilla can prevent acute~     pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a~     prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent~     PEP after ERCP.~   "
16654|NCT02839343|"~     The purpose of this study is to compare any good and bad effects of using chemotherapy~     compared to chemotherapy and radiation prior to surgery. This study will allow the~     researchers to know whether which approach is better, the same, or worse than the other.~   "
16655|NCT02839330|"~     This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots~     of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18~     years of age receiving the vaccine and 798 healthy adults receiving placebo. Subjects will~     be randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment~     will be stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate~     safety assessment of the entire age spectrum.~   "
16656|NCT02839317|"~     The cause of CD could be different according to age at onset of CD symptoms. Indeed we know~     that some very young patients at CD diagnosis have particular genetic variants as~     abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way,~     the microbiota also undergoes substantial changes at the extremes of life, in infants and~     older people and the ramifications of which are very few being explored. The comparison of~     microbiota by principal component analysis and genetic profile of patients with CD beginning~     at the extremes of life could help us to better known physiopathology of CD according to age~     and provide arguments that CD beginning at the extremes of life could be different diseases.~      The aim of the study is to ascertain through population-based study the hypothesis that gut~     microbiota is different between paediatric-onset and elderly-onset CD patients in relation~     with genetic and environmental mechanisms. The results will provide a better knowledge of~     the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD~     onset (i.e. according to the gut bacteria involved).~   "
16657|NCT02839304|"~     The objective of the study is to demonstrate the safety and feasibility of the PolarStar~     system is subjects with Paroxysmal Atrial Fibrillation.~   "
16658|NCT02839291|"~     To evaluate the current medical practice and its influence on health-related quality of~     life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates~     or denosumab) for at least one year.~   "
16659|NCT02839278|"~     The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory~     treatment on costimulatory molecules expressed on monocytes.~   "
16660|NCT02839265|"~     Based on promising data from our laboratory demonstrating synergy between ablative local~     radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are~     performing a phase II study combining FLT3L immunotherapy and SBRT for patients with~     advanced NSCLC that has progressed following standard systemic therapy. All patients will~     receive daily subcutaneous injections of CDX-301 (75 µg/kg) for 5 days, beginning on the~     first day of SBRT. SBRT will be delivered to a single pulmonary lesion. Depending on the~     size and location of the target lesion, the SBRT regimen will be 34 Gy x 1 (peripheral~     tumors smaller than 2 cm and not adjacent to the chest wall), 18 Gy x 3 (peripheral tumors~     not eligible for 34 Gy x 1), or 10 Gy x 5 (central tumors). The primary endpoint will be~     progression-free survival at 4 months, defined using immune-related response criteria~     (irRC). A total of 29 patients will be enrolled.~   "
16661|NCT02839252|"~     The specific aims of this pilot study are to:~        1. Evaluate the effectiveness of the asthma education intervention on asthma knowledge~        2. Determine whether the asthma education intervention improves child and parent asthma~          treatment self-efficacy~      Our hypothesis is that the asthma education intervention will significantly improve asthma~     knowledge and asthma self-efficacy at 1 month post-intervention as compared to controls.~   "
16662|NCT02839239|"~     The objective of this study is to determine an efficacy of the combination of L. rhamnosus~     19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in~     infants aged 4 through 12 weeks with IC. The active group of infants will receive~     lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily~     as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and~     at the end of intervention to define a difference between the groups~   "
16663|NCT02839226|"~     This prospective, placebo-controlled, double blind, randomized study is designed to assess~     the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies~     including arterial ulcers, diabetic ulcers and venous ulcers, of at least 3 months duration.~     After collection of comprehensive medical data to confirm eligibility of patient and~     obtaining informed consent , patients will enter Screening run-in Period where all wounds~     will be cleaned if necessary by surgical debridement and irrigation (isotonic solution)~     prior to initiation (run-in phase) of the study according to physician's instructions.~     During the 14 day screening period, all subjects will receive standard of care (SoC) on a~     daily basis, as per indication and patients status, according to physicians instructions.~     Wounds will be morphologically assessed by the treating physician and by photographic~     evaluation by the PI once a week - at days 7 and 14 of the screening run-in phase. Following~     the run-in period, Subjects with wounds of ≥ 5cm2 and ≤100 cm2 of at least 3 months duration~     that fail to respond to treatment with SoC during the screening run-in phase will be~     enrolled into the study. Eligible subjects with wounds will be randomized and treated~     topically with AR/101+ SoC or placebo +SoC once daily for up to 14 days. During this~     treatment phase I, depending on their wound size and wound type, subjects will receive~     treatment dose applied topically daily and wounds will be dressed according to physician's~     instructions. Wounds will be photographed daily and assessed by the treating physician in~     the clinic once a week (at the end of each weekly period). During the treatment period,~     adverse events and concomitant medications will be monitored; wounds will be morphologically~     assessed by photo documentation and followed for wound bed progression and granulation~     tissue formation. At the end of Treatment period I, patient's wounds will be analyzed and~     all patients from both treatment arms with wound score 0-2 will be assigned to receive the~     study drug for and additional up to 14 days treatment phase II in full accordance with the~     treatment regimen described in Treatment phase I. A termination visit will be performed at~     day 14 of Treatment phase I or II or earlier if the wound has reached the maximum score on~     the granulation scale or if the wound is ready for skin grafting; or in any case of early~     withdrawal that is not due to withdrawal of consent.~   "
16664|NCT02839213|"~     The management of normal labor is both an art and a science. For decades, health providers~     have worked to manage labor actively and safely, with the goal of shortening the duration of~     painful labor. Reduction of Cesarean sections and other fetal and maternal complications is~     also an important aspect of labor management.~      The safety of active management of labor has been demonstrated by several prospective~     randomized clinical trials. A shorter duration of labor from admission to delivery has also~     been consistently reported in numerous studies of women treated with the active management~     protocol.Hyoscine butylbromide belongs to the parasympatholytic group of drugs and is a~     semisynthetic derivative of scopolamine. It is an effective antispasmodic drug without the~     untoward side effects of atropine. Hyoscine butylbromide is a quaternary ammonium compound~     and has peripheral anticholinergic action, but no central action as it does not cross the~     blood-brain barrier. Hyoscine butylbromide acts primarily by blocking the transmission of~     neural impulses in the intraneural parasympathetic ganglia of abdominal organs, apparently~     inhibiting cholinergic transmission in the synapses of the abdominal and pelvic~     parasympathetic ganglia, thus relieving spasms in the smooth muscles of gastrointestinal,~     biliary, urinary tract, and female genital organs, especially the cervico-uterine plexus,~     thus aiding cervical dilatation.~      Spasmolytic drugs are frequently employed in delivery rooms to overcome cervical spasms and~     thus reduce the duration of labor.~      Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals~     in the world. The mechanism by which it acts in the context of labor has not yet been~     elucidated, and evidence of its efficacy has been largely anecdotal.~      Major studies have been carried out to evaluate the effects of the injectable or suppository~     form of Hyoscine butyl bromide on cervical dilatation; a majority of these studies~     demonstrated the efficacy of Hyoscine butyl bromide in augmenting labor. However, a few~     studies showed no effect of Hyoscine Butyl bromide on accelerating labor. In addition, some~     studies also used oxytocin in active management of labor, which would certainly affect the~     duration of labor and increase bias in the results. The specific objectives of this study~     will be to assess whether Hyoscine butyl bromide is effective in hastening cervical~     effacement and dilatation, thus shortening the duration of the first and second stages of~     labor with or without labor augmentation. We also intended to determine whether the use of~     Hyoscine butyl bromide in the first and second stages of labor has any associated increases~     in complications, such as an increase in blood loss or the rate of cesarean deliveries.~   "
16665|NCT02839200|"~     The primary objective of this study is to assess the effect of ACT-541468 on a measure of~     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with~     insomnia disorder.~   "
16666|NCT02839187|"~     The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients,~     who responded to strict physiological criteria typical of AD pathology. The objective of the~     present study was to identify the earliest alterations in cerebral connections that could~     contribute to the initial episodic memory impairment.~   "
16667|NCT02839174|"~     The investigators have identified a support group on social media with ~1500 members~     (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted~     diet. Many participants report exceptionally low HbA1C and insulin requirements. If these~     anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical~     trial would be warranted.~      The investigators propose to survey the above-mentioned group and their professional~     diabetes care providers to characterize glycemic control and explore associated dietary and~     diabetes care factors.~   "
16668|NCT02839161|"~     Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in~     hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon.~     Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine~     co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B~     vaccine co-administered with sterile saline. All injections will be delivered~     intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.~   "
16776|NCT02837757|"~     Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with~     metastatic renal cell carcinoma.~      The objective of this study is to investigated the influence of everolimus immune modulation~     on antitumor efficacy .~   "
16777|NCT02837744|"~     To evaluate Safety and Efficacy of Axiostat® hemostatic dressing as compared to Standard~     Institutional Care product in terms of time to achieve hemostasis, post application~     complication and comfort levels of patients.~   "
16669|NCT02839148|"~     This study will provide a tool for researchers to measure important outcomes in relation to~     trial of intervention to reduce or prevent stunting.~      Hypothesis: We assume that appetite score will be associated with improvement in growth and~     development parameters of children given the nutrition and psychosocial stimulation~     intervention~      Objectives:~      To explore maternal perception regarding childhood stunting To develop and validate an~     appetite measuring tool To assess the appetite status of young children To examine the~     relationship between appetite score, growth and development, potential biomarkers of~     appetite, child food intake and intestinal inflammation of the children.~      Methods: In the first phase, a qualitative study will be conducted to explore maternal~     perception regarding childhood stunting and to develop a tool- the Early Childhood Appetite~     and Satiety Tool(ECAST) using mixed method approach (qualitative and quantitative). In the~     second phase, a community-based trial will be conducted with 50 stunted children of aged~     12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children~     (non-stunted).~   "
16670|NCT02839135|"~     In this comparative bioavailability and in vivo skin adhesion study, the impact of minor~     changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and~     change of the manufacturing line of the micro porous membrane will be tested.~   "
16671|NCT02839122|"~     This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic~     interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy~     male volunteers.~   "
16672|NCT02839109|"~     In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by~     surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of~     the patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival~     benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional~     failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with~     computed tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but~     still misses significant clinical evidence. Whole-body diffusion-weighted imaging (DWI)~     magnetic resonance imaging (MRI) has shown potential benefits, which might be enhanced by~     combining both methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic~     FDG-avid lesions and seem to assess post-treatment changes, especially regarding nodal~     staging. Both techniques claim an important role in selection of patients with clinical~     complete response (cCR) and indirectly with pathologic complete response (pCR) after nCRT.~     However, the exact role and complementary effects of both techniques is still unknown.~      For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with~     fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual~     tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery,~     approximately 6-10 weeks after nCRT and compared with the situation at primary staging.~     Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0)~     after nCRT may refrain from surgical resection and related morbidity and mortality. However,~     patients without early (2wk after commencement) response during nCRT course may not benefit~     from nCRT.~      DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion~     coefficient (ADC), which indirectly measures tissue density, can be used to determine the~     likelihood of tumor response to treatment. High ADC before treatment has shown to predict an~     unfavorable response. Tumors with low ADC values on presentation generally respond better to~     treatment. An increased ADC in patients during and after nCRT could be used to predict early~     pathologic response i.e. discrimination of responders and non-responders to nCRT.~   "
16673|NCT02839096|"~     The investigators will randomize women diagnosed with anemia in the mid-trimester of~     pregnancy to once or twice daily iron supplementation~   "
16674|NCT02839083|"~     Breast surgeries are usually associated with significant postoperative pain. Suitability of~     analgesic technique after breast surgery is always questionable. The aim of this study is to~     compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance~     as regards to potential complications and analgesic efficacy of both techniques in the first~     24 h after modified radical mastectomy.~   "
16675|NCT02839070|"~     The study is a combination of outpatient and inpatient monitoring. During the 27-day~     inpatient portion of the study, the individual's sleep-wake schedule will be varied daily.~     Volunteers will be randomized to a regular or irregular inpatient schedule.~   "
16676|NCT02839057|"~     Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the~     elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while~     surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment~     or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of~     retrospective studies has recently found an improved survival with surgical treatment. This~     national registry study is designed to estimate the survival of non-surgical and surgical~     treatment in a population-based cohort.~   "
16677|NCT02839044|"~     Arterial calcification is an independent predictor of coronary events associated with a 3-4~     fold increased risk of cardiovascular events. Currently, no effective intervention exists to~     reduce arterial calcification. However, recent studies showed that vitamin K may reduce~     ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification.~      The primary objective is to determine if MK-7 supplementation leads to stabilization or~     attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF~     PET/CT imaging in patients with type 2 diabetes and arterial disease.~   "
16678|NCT02839031|"~     Diabetes mellitus in children and adolescents is a source of stress and poor quality of life~     for themselves and their family. Development of adaptive coping strategies may be improved~     by focused parent and children training. This study assesses a cognitive behavioral~     treatment (CBT) for children/adolescents with diabetes and their parents in comparison with~     standard health educational interventions. The investigators main aim is to verify that the~     CBT program improves overall balance of glycaemia better than phone contact without CBT~     content (control group). Secondary objectives are expected improvements of health-related~     quality of life and coping styles in parents and children.~   "
16679|NCT02839018|"~     Little is known about nutritional Parameters that potentially influence the course of~     intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the~     nutritional profiles in blood, urine and muscle in respective patients at risk.~   "
16704|NCT02838693|"~     The Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of~     Type 2 Diabetes (BRITE-SPOT) has been set up to prospectively collect clinical data and~     biologically relevant samples from individuals with, and at risk for type 2 diabetes (T2D),~     with the aim of delineating factors related to susceptibility, progression, complications~     and response to treatment. Expanded from BRITE-SPOT, Assessing the Progression to Type - 2~     Diabetes (APT-2D) is a prospective cohort with a focus on non-diabetics (normoglycemic or~     prediabetic), to expand the sample size and depth of metabolic phenotyping in these upstream~     groups, with the more targeted aim of delineating factors related to insulin sensitivity~     versus secretion, that relate to progression to T2D.~   "
16680|NCT02839005|"~     Context: Cesarean section is the most common surgery in women, both in developed and~     underdeveloped countries. However results are conflicting report in which material for~     intradermal suturing get better aesthetic result. Objective: To compare the aesthetic~     appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal~     sutures for skin closure in women undergoing cesarean section first. Methods: This is a~     clinical, prospective and randomized study which was conducted in the Department of~     Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in~     PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first~     included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30)~     polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a~     score, according to Trimbos table, six months after surgery. Later the results were compared~     to non-parametric statistical tests~   "
16681|NCT02838992|"~     To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate~     hematopoietic reconstruction in severe aplastic anemia patients and improve clinical~     curative effect and safety~   "
16682|NCT02838979|"~     The primary goal of proposed investigation is to study the impact of oral glutamine~     supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial~     energetics and vascular function using 31P magnetic resonance spectroscopy and optical~     spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to~     describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as~     well as inflammatory and oxidative stress biomarkers among persons with chronic kidney~     disease.~   "
16683|NCT02838966|"~     The purpose of this study is to determine the optimal effective dose for preoperative~     nutritional supplementation with immunomodulators on immune function and perioperative~     outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.~   "
16684|NCT02838953|"~     To determine whether the COPD impairs the diaphragmatic mobility (DM), and verify~     improvements after an inpatient pulmonary rehabilitation (PR).~      Ultrasonography on M-mode will assess the diaphragmatic mobility at rest breathing and at~     slow deep inspiration. Lung functions test, arterial blood gas analyses, six minute walk~     test will be also performed, on COPD patients and healthy subjects.~   "
16685|NCT02838940|"~     Background~      Preventive antibiotic treatment before performing invasive procedures is a basic element in~     preventing infections. The essence of preventive antibiotic treatment is strengthening the~     defense mechanisms of the immune system by preserving a certain drug levels in the blood.~     The timing of giving the antibiotics is very important. Several research groups have tried~     to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in~     serum and adipose tissue in women during cesarean. These groups presented conflicting~     research results.~      OBJECTIVE~      This study will discuss the preventive antibiotic treatment levels accepted prior cesareans,~     to determine:~        1. What are the factors affecting the level of drug in the blood?~        2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal~          Inhibitory Concentration)?~        3. Is the provision of usual preventive care also addresses the situations of metabolic~          disorder?~   "
16686|NCT02838927|"~     Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none~     exists specifically for France. Hypoparathyroidism could led to complications. Here, the~     investigators plan to collect data about both epidemiology, medication and complication of~     hypoparathyroidism in France.~   "
16687|NCT02838914|"~     The purpose of the study is to assess the reconstruction and inverse reconstruction in right~     atrium by speckle tracking echocardiography combined with real-time three dimensional~     echocardiography for atrial fibrillation patients before and after radiofrequency ablation~     (RFCA)~   "
16688|NCT02838901|"~     This is a double-blind, randomized, placebo-controlled, pilot study. Participants will be~     randomized to receive either beetroot juice or a beetroot juice placebo, as a dietary~     supplement, for 30 days. Beetroot juice is high in nitrates, a chemical when ingested is~     found to increase blood flow to the brain. The purpose of this research study is to~     determine the safety and feasibility of using this nutritional intervention in~     (ischemic)stroke survivors, and prove that plasma levels of nitrate and nitrite increase as~     expected. Secondary outcomes includes measuring a comprehensive set of outcomes related to~     functional status post-stroke, including mobility, upper extremity strength, cognition,~     depression, and disability. Patients will also be randomized to MRI perfusion scanning in~     the region of the stroke to measure cerebral blood flow.~   "
16689|NCT02838888|"~     Screening colonoscopy is considered the gold standard for adenoma detection in the colon.~     However, it has been shown that a considerable number of polyps can be missed during~     screening colonoscopy. Until now the endoscopist himself is responsible for the detection of~     adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect~     lesions. Recently, a computer program was developed that can be used to recognize and~     extract suspicious structure from colonoscopy video sequences. The program was built to~     automatically detected colonic polyps and to highlight the polyps by colour marking. The~     program was now refined so that the respective structures can be highlighted during real~     time colonoscopy. The aim of this feasibility study is to test whether the software is~     applicable during real time colonoscopy.~   "
16690|NCT02838875|"~     Background Neonatal hypoglycemia is one of the most common metabolic disorders in~     neonatology. Maintaining stable levels of glucose in the transition from fetal life to life~     after birth is very important. Yet, except for the recognizing of at-risk populations, there~     are not many individual measures which can help and predict which newborns (from at-risk~     populations) will develop hypoglycemia and which will not.~      OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth~     and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the~     hours after birth in the population that is at increased risk of this complication in~     advance.~   "
16705|NCT02838680|"~     To evaluate the safety and performance of the HLT System in patients with severe aortic~     stenosis who present at high risk for aortic valve replacement surgery.~   "
16706|NCT02838667|"~     Nephrology participation in care of patients undergoing CABG could reduce AKI through~     correction of modifiable risk factors and early detection and intervention of post-op AKI.~   "
16707|NCT02838654|"~     The purpose of this study is to analyze the reliability of epidural wave form during~     cerivical epidural injection.~   "
16691|NCT02838862|"~     Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years~     as rare tumors, their incidences are increasing. Due to their potential of early metastases~     and their heterogenous response to therapy, these tumors are important clinical entities. A~     major problem remains the impossibility to adequately predict tumors' response to treatment,~     precluding an individualized therapy. Further, there is no method to efficiently screen~     these tumors. Protein based analyses (proteomic analyses) gain in interest as methods to~     address this problematic.~      The present study was designed to investigate epidemiologic data of patients with GEP-NEN~     and to answer following questions using proteomic analysis applied to existing pathology~     specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures~     in this type of tumors? Is the response to therapy predictable using specific protein~     signatures? Is the tumor's tendency to metastasize related to specific protein signatures?~   "
16692|NCT02838849|"~     Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of~     life, fecal characteristics and microbiota) measured during a week of monitoring followed by~     randomization to a 14 days course of increased fiber in diet or increased fiber and water~     intake, with repetition of parameters measuring at the end.~   "
16693|NCT02838836|"~     Patients with resectable solid primary cancers and even limited number of metastases are~     potentially curable. However, most patients develop recurrences despite surgery. Circulating~     and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the~     blood, urine and bone marrow will increase understanding of cancer spread and advance~     knowledge to develop individualized therapies.~   "
16694|NCT02838823|"~     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with triple negative breast cancer who have failed in~     routine systemic treatment. The study will be conducted in 2 parts: dose escalation and~     cohort expansion to investigate tolerability and efficacy.~   "
16695|NCT02838810|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha and NAs.~   "
16696|NCT02838797|"~     This is a study to determine the safety and tolerability of a new medicine (RQ10) for~     gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look~     at the effect of this medicine on gastrointestinal problems. The results will determine if~     future studies are appropriate. In this study, RQ10 will be compared to a placebo (a~     look-alike inactive substance). Participation will include multiple office visits.~     Approximately 48 people will participate.~   "
16697|NCT02838784|"~     This study will compare the proportion of patients who have wound closure within 12 weeks as~     well as the time to wound closure in patients receiving Artacent™ versus standard of care~     for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be~     assessed at 6 months via a telephone survey~   "
16698|NCT02838771|"~     The aim of this research was to develop a dysphagia screening measure and evaluate the~     prevalence of dysphagia and its clinical manifestation in different in age population~     groups.~   "
16699|NCT02838758|"~     The purpose of this study is to evaluate the effectiveness of a device that delivers~     freezing temperature compared to injecting lidocaine (an anesthetic medication) in providing~     pain relief to patients with disorganized nerve bundle between the toes, also known as~     Morton's neuroma. The same ultrasound technology that the obstetricians use to visualize a~     fetus inside a pregnant woman will be used to help the study physician to locate the~     Morton's neuroma while precisely delivering the freezing temperature and lidocaine near the~     nerve.~   "
16700|NCT02838745|"~     Primary Objective~      To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed~     when given in conjunction with cisplatin in patients with resectable malignant pleural~     mesothelioma MPM.~      Secondary Objectives~      To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic~     Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable~     MPM.~      To assess overall survival and progression-free survival after PD or EPP and HIOC with~     cisplatin and pemetrexed for MPM~      Correlative Objectives~      To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as~     a hyperthermic intrathoracic lavage after PD or EPP~      To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM~     tissue correlates with clinical response to pemetrexed.~   "
16701|NCT02838732|"~     In this project, the investigators aim to investigate if daily carnitine supplementation~     could induce TMAO productivity of vegetarian gut microbiota and through which the TMAO~     producers might be disclosed.~   "
16702|NCT02838719|"~     Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides~     analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal~     wall. In the past, a number of adjuvants have been added to the local anaesthetics in~     peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In~     recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics~     in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure~     and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When~     added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to~     prolong the analgesia time. A number of previous studies have also shown an opioid sparing~     effect of steroids, when used intravenously perioperatively. Though previous studies have~     shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane~     block prolongs the duration of block, however it is not known whether this effect of~     dexamethasone is due to its peripheral action or because of its systemic absorption. Thus,~     in this study planned to compare the effectiveness of dexamethasone on quality and duration~     of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane~     block versus when given systemically by intravenous route along with transverse abdominis~     plane block using local anaesthetics only, in patients undergoing gynaecological~     laparoscopic procedures under general anaesthesia.~   "
16703|NCT02838706|"~     The overall aim of the study is to investigate the time difference in the diagnosing of~     anemia among elderly with hip fracture, between measurements with standard blood samples and~     non-invasive SpHb-measuring. Another aim is to investigate the relationship between~     perfusion index and prolong perioperative anemia and the potential impact on perioperative~     complications.~   "
16708|NCT02838641|"~     This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for~     GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis~     (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation~     procedures, will be recruited for this study over a period of 18 months. Clinical likelihood~     of TB will be systematically scored according to various clinical parameters. This will~     determine the pre-test probability. Clinician will decide if anti-TB treatment is to be~     started and patients will be followed up for a minimal of 18 months. Sensitivity,~     specificity, positive, negative predictive values and the respective likelihood ratio will~     be calculated accordingly.~   "
16709|NCT02838628|"~     In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment will be~     evaluated in adult subjects with a clinical diagnosis of stable, clinically typical actinic~     keratosis (AK) on the face or scalp.~   "
16710|NCT02838615|"~     The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural~     spreading and provocation of concordant paresthesia, amount of radiation exposure and total~     procedure time between transforaminal and parasagittal interlaminar epidural injection.~   "
16711|NCT02838602|"~     This is a transnational prospective randomized trial comparing definitive carbon ion therapy~     versus photon or combined photon and protontherapy as standard treatment for unresectable or~     macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial~     chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of~     trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously~     irradiated and without pre-planned surgery or chemotherapy after the clinical trial~     procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated~     in carbon ions centers in Europe and patients of the standard arm are treated in France in~     their closest participating radiotherapy center. An accrual of 250 patients is needed and an~     absolute difference of 20% of relapse free survival at five years is awaited. The main~     endpoint is the progression free survival at five years. The trial is supported by the~     French program of clinical research and the national health insurance. Two associated~     studies are carried out: a radiobiological one looking for radioresistance markers in the~     sarcomas biopsies, and the second one is about medico economics.~   "
16712|NCT02838589|"~     This randomized controlled trial investigates the effect of a single dose of glucagon-like~     peptide-1 (GLP-1) receptor agonist on cerebral blood flow velocity and cortical oxygination~     in humans without cerebrovascular disease. This study serves as a control for a similar~     study investigating the effect in stroke patients (ref. to EGRABIS1).~   "
16713|NCT02838576|"~     Arthralgia has been a common complaint in postmenopausal period which seems to be involved~     with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems~     to relate with the level of physical activity, climacteric symptoms and pain~     catastrophizing. In view of the multiple dimensions involved in arthralgia in postmenopausal~     women which characterize it as a complex phenomenon, this study aims to describe the effects~     of hormone replacement therapy in women aged between 45 and 55 years, considering estrogen~     as a possible anti-nociceptive factor.~   "
16714|NCT02838563|"~     Current scales are not suited to a direct measure for the elderly with cognitive disorders~     and are difficult to handle for the care teams. In this context, a visual analog scale was~     created to answer a single question How are you feeling now, immediately? with the help of~     pictograms. This study aims to assess the validity and reliability of the Scale of~     Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre~     (EVIBE)) in people with Alzheimer's disease or a related disease.~   "
16715|NCT02838550|"~     The aim of this study is to analyze the effect of a motivational online intervention (MOI)~     using pedometers to increase physical activity in a sample of sedentary students. It will be~     compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a~     pedometer of new generation); MOI condition (access to a MOI and the use of a blinded~     pedometer); and CONTROL condition (the use of a blinded pedometer).~   "
16716|NCT02838537|"~     This study will be conducted as a retrospective study of exposed and unexposed cohort of the~     French population included all beneficiaries aged 65 and older. Exposed patients will be~     matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two~     exposed arms and two non exposed control arms will be planned. Triptan arm will be user of~     triptan defined as at least one recorded dispensing of any drug during the follow up, with~     no recorded of any of these drugs during the previous 6 months (new or incident users).~     Ergot arm will be user of ergot derivative defined as at least one recorded dispensing of~     any drug during the follow up, with no recorded of any of these drugs during the previous 6~     months (new or incident users). This study involved data from the French National Health~     Insurance Information System (Système National d‟Information Inter-Régimes de l‟Assurance~     Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de~     Médicalisation des Systèmes d‟Informations, PMSI).~        -  The SNIIRAM is a vast national medico-administrative database representing the most~          part of the French population, allowing to identify and to describe precisely all~          medication dispensations (name of drug, date of dispensing and quantity) including~          triptans and other reimbursed medications.~        -  The PMSI provides medical information about all patients admitted to hospital in~          France, including discharge diagnoses encoded according ICD-10, medical procedures and~          French diagnosis-related groups The research proposed is expected to provide an update~          and nationally-consolidated estimation of the cardiovascular risk is associated to~          triptans use in elderly population.~   "
16726|NCT02838407|"~     The purpose of this study is to identify and characterise bacteria present in the lower~     airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL)~     is indicated by the clinician.~   "
16752|NCT02838069|"~     ASCs will be administered via intra-articular use into the knee joint affected by OA where~     they are expected to exert their therapeutic effects.~      The objective of this clinical trial is to generate efficacy and tolerability profiles of~     single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when~     administered locally into a knee joint affected by OA after in vitro cell expansion. The~     potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this~     chronic and debilitating disease will be assessed by MRI after 1 and 2 years.~      This will be a phase IIb, multi-centre, prospective, randomized, double-blind study,~     comparing culture-expanded autologous ASC with placebo.~   "
16717|NCT02838524|"~     Partially assisted mechanical ventilation is ideally titrated to maintain adequate~     inspiratory muscle activity (i.e. preventing disuse atrophy) while avoiding excessive (i.e.~     fatiguing) inspiratory loads. The advent of ventilator modes enabling flow and pressure~     assistance in proportion to patient inspiratory effort (i.e. Proportional Assist Ventilation~     (PAV), Neurally-Adjusted Ventilator Assist (NAVA)) permit careful titration of ventilatory~     support to achieve desired levels of patient inspiratory effort. However, data on the~     acceptable range of values for inspiratory effort and respiratory muscle load-capacity~     balance during mechanical ventilation are currently very limited. Such data are critical to~     inform a physiologically sound evidence-based approach to titrating partially-assisted~     ventilatory support. This study is designed to ascertain a physiologically acceptable range~     of inspiratory effort in mechanically ventilated patients. The study protocol includes~     measurements of the respiratory system during spontaneous breathing as well as evaluating~     the diaphragm in real-time with the use of ultrasonography. The experimental design outlined~     in the present study is predicated on the assumption that the range of values for~     inspiratory effort and load-capacity balance observed in patients who are successfully~     weaned from mechanical ventilation represent the safe and appropriate range of target~     values.~   "
16718|NCT02838511|"~     Though most physicians believe they can identify frail patients, frailty is a poorly~     characterized and complex clinical syndrome. Frailty has been categorized four dimensions by~     de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy);~     2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and~     mood); and, 4) social (social contact and support). 1 However, the pathophysiology of~     frailty remains unclear. Two broad hypotheses have been proposed.~      Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation~     and additive effect of multiple deficits, which occur across various domains. The more~     deficits a person has, the more likely that person is to be frail. Frailty in this paradigm~     is thus measured by identifying the number of positive factors/ deficits from a list. This~     is used to create a proportional index of deficits, expressed as the ratio of deficits~     present to the total number of deficits considered.~      Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to~     correlate well with patient outcomes after surgery.~      Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she~     identified various clinical features that define frailty as a clinical syndrome. This~     criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion,~     slowness, and low physical activity level. The Fried index is the most commonly used~     phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during~     preoperative visits. Measurement of these factors in a perioperative setting was further~     characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score~     (HFS).~      Currently, there exists no gold standard for assessment of frailty, especially in the~     perioperative setting. In the absence of a well-accepted gold standard, a measurement of~     frailty which would predict adverse postoperative outcomes would be useful. However, no~     study has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery.~      All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic~     main campus will be included in the this prospective observational cohort study. Frailty~     would be evaluated prospectively using HFS and components of MFI will be obtained from~     Cleveland Clinic Perioperative Health Documentation System registry (PHDS).~   "
16719|NCT02838498|"~     To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP~     cannulation success rate of novice surgical trainees.~   "
16720|NCT02838485|"~     Goals : ( a) to examine differences in cortical activity during hand movements with a mirror~     compared to imagery of the same movements, and (b) to examine correlation between cortical~     activity during imagery or mirror treatment and the pain and performance measures in finger~     amputees.~      A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI)~     preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue~     Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and~     Jebsen Taylor Hand Function Test will be used.~   "
16721|NCT02838472|"~     Nicotinamide nucleotide transhydrogenase (NNT) mutations cause glucocorticoid and~     mineralocorticoid deficiencies through decreased detoxification of reactive oxygen species~     (ROS) in adrenocortical cells.~      Ascorbic acid is well known by its high antioxidant activity due to the neutralization of~     free radicals and other reactive oxygen species.~      Preliminary results of NNT_p.G200S homozygous fibroblasts' treatment with 10 micro molar~     L-ascorbic acid shows significant improvement in mitochondrial morphology and in ROS~     content.~      The aim of this study is to figure out if ascorbic acid treatment improves the phenotype of~     NNT patients by reducing ROS in their adrenocortical cells and preventing their apoptosis.~   "
16722|NCT02838459|"~     Using a prospective cohort design, the aim of this study is to compare the performance of~     clinicians with prediction models in triaging trauma patients.~   "
16723|NCT02838446|"~     The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery~     (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was~     carried out on 36 patients. These patients were randomly assigned to two groups: classic~     treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week)~     physical therapy and rehabilitation intervention. Outcome measurements were based on upper~     extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand~     Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale),~     range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation~     with goniometer), grip strength (standard grip strength with Jamar hydraulic hand~     dynamometer; lateral, palmar and pinch strength with pinch meter).~   "
16724|NCT02838433|"~     The impressive clinical responses obtained with immune checkpoint inhibitors~     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune~     response might be required for their efficacy and highlight the critical role of antitumor T~     cell immunity.~      Recent progresses on the field of tumor immunology underline the critical role of CD4 helper~     1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore,~     monitoring tumor specific TH1 response could be relevant in cancer patients.~      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the~     investigators team have previously described novel promiscuous peptides (referred as UCP:~     Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor~     antigen.~      By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this~     study in melanoma before and after treatment.~   "
16725|NCT02838420|"~     This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and~     safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in~     asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be~     randomized 2:1 into one of the two treatment groups to receive either alectinib (600~     milligrams [mg] twice daily [BID]) or crizotinib (250 mg BID) orally, respectively.~   "
16727|NCT02838394|"~     Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are~     inserted into myofascial trigger points or other tissues underneath the skin. It is used to~     treat myofascial or neuromusculoskeletal pain and to improve movement impairments. Although~     more and more physical therapists add this treatment tool to their skill box, there is~     uncertainty about its working mechanism and its efficacy. The latter is partially due to the~     challenging task of finding and using a true control or sham treatment. The investigators~     will use blunted needles, which will not perforate the skin, as sham treatment.~      This study will assess if DN of a trigger point in the gluteal muscles increases pain~     pressure threshold in that muscle, in another muscle innervated by the same segment (L4/5)~     and in an area not supplied by the same segment (i.e. the ipsilateral posterior shoulder).~     In addition, this study will assess if functionality, as measured by the Oswestry Disability~     Index (ODI) and 15-point Global Rating of Change Scale (GRoC) questionnaires, improves after~     2-3 treatments (1 week) of DN.~   "
16728|NCT02838381|"~     The aim of this study is to characterize the genetic and cellular immunological parameters~     of metastatic digestive cancer patients having short and long responses to chemotherapy.~   "
16729|NCT02838368|"~     The incidence of type II glycogen-storage disease (Pompe disease) varies depending on~     ethnicity and geographic region. As of 2010, nine studies have been published documenting~     the incidence of Pompe disease. It is most common within the African American population,~     with an incidence of 1 in 14,000. In the U.S. more broadly speaking, the combined incidence~     of all three variants of the disease is 1 in 40,000. These estimates relied on the~     frequencies of three mutations in the gene acid alpha-glucosidase (GAA), leading to variants~     of the disease. Criteria for inclusion in the studies were often non-selective; in many~     cases, molecular genetic screening was done at birth. With such a high prevalence of Pompe~     disease reported, it is expected that large university medical centers specializing in~     neuromuscular diseases would see a higher incidence of Pompe disease among their patients.~     From a comparable Italian multicenter study, it appears that Pompe disease accounts for 3%~     of all patients presenting with proximal weakness with or without CK elevation.~      This study will measure the incidence of Pompe disease based on manifest laboratory~     abnormality, namely low GAA enzyme activity. Analysis of GAA enzyme activity will be~     determined through a blood sample of 4 mL. The study seeks to measure the epidemiology of~     Pompe disease by symptomatically screening all patients who present with symptoms of~     hitherto undiagnosed proximal weakness with or without elevation of the muscle enzyme,~     creatinine kinase (CK), or elevation of CK alone, at thirteen academic tertiary~     neuromuscular practices throughout the United States and Canada. Total recruitment is~     expected to be ~1,500 participants. It is anticipated that the number of incident Pompe~     cases in this cohort would be between 3-5%, i.e. 45-75 newly diagnosed cases of Pompe~     disease.~   "
16730|NCT02838355|"~     The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via~     nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory~     complications. This device will detect the amount of carbon dioxide exhaled with each breath~     and may better predict high levels of this than traditional monitoring. This may reduce the~     number and severity of respiratory issues. A convenience sample of 60 participants either~     scheduled for continuous flow left ventricular assist device (CF-LVAD) implant or who have~     been readmitted to an ICU with a CF-LVAD will be recruited and randomized to usual care or~     usual care plus ETCO2-NC throughout their stay in the ICU.~   "
16731|NCT02838342|"~     This study will evaluate the potential immunomodulatory synergy of the association of~     metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).~   "
16732|NCT02838329|"~     The purpose of this study is to determine weather using warmed (body temperature) 0.75%~     Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset~     time of surgical block, compared to standard room temperature~   "
16733|NCT02838316|"~     The primary objective of this study is to evaluate the safety of Autologous Muscle Derived~     Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of~     tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or~     radiotherapy for squamous cell cancer of the oropharynx.~   "
16734|NCT02838303|"~     The purpose of this study is to evaluate self-reported symptoms as a proxy for acute~     organophosphate poisoning by examining self-reported acute organophosphate poisoning~     symptoms and PchE activity in response to occupational acute organophosphate exposure among~     farmers in Nepal.~   "
16735|NCT02838290|"~     Background: Over 39% of approximately 3,000 doctors (The British Medical Association~     quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded,~     tired, low and lacking energy. Such occupational distress may link to psychological and~     physical difficulties in doctors and have negative outcomes for organization and patients.~     The aim of the current study is to investigate the impact of an induction programme on~     occupational distress of doctors.~      Methods/design: Doctors will be invited to take part in an online research. Participants~     will be randomly assigned to the experimental and control groups. Participants in the~     experimental groups will complete one of the induction topics (about stress at work). Before~     and after an induction programme participants will be asked to fill in an online survey~     about their current occupational distress and organizational well-being.~      Discussion: The investigators expect that doctors' psychological, physiological and~     organizational well-being will improve after an induction programme which should serve as a~     resource for better doctor's own health understanding.~   "
16736|NCT02838277|"~     The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT)~     disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT~     in these disorders that is resistant to diet and exercise.~   "
16737|NCT02838264|"~     The purpose of this study is to estimate the effect of itraconazole on the single dose~     pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.~   "
16751|NCT02838082|"~     OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI~     during inpatient rehabilitation. Twenty participants will be allocated (by minimization)~     either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep~     efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior~     Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the~     trial period to examine relationships among them.~   "
16738|NCT02838251|"~     About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD)~     associated. The compression band is still a controversial issue in this context. It allows~     the reduction of venous hypertension and edema, but it could potentially degrade the~     arterial infusion of high levels of compression. The French High Authority for Health (HAS)~     defines mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers~     blood predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood~     with moderate involvement for IPS values between 0.7 and 0.9.~      Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg.~     In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter~     compression, bit by elastic bands (exercising low power compression at rest) under medical~     supervision, informing the patient to remove the bandage if pain or aggravation. It is~     therefore necessary to adapt the compression therapy in case of venous ulcers associated~     with arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS~     <0.6 against indicates compression.~      A recent study showed that compression bit elastic bands could not only improve venous~     return, but it would also increase the distal arterial flow in a patient population with~     mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain~     patients below the threshold of 0.6 indicates that against a compression according to HAS.~     To our knowledge this is the only study that has examined the effect of compression on blood~     perfusion.~   "
16739|NCT02838238|"~     Our study is a prospective, randomized phase II clinical trial, to compare the efficacy and~     safety profiles of single X versus placebo as adjuvant chemotherapy regimens for elder~     breast cancer patients.~   "
16740|NCT02838225|"~     Our study is a prospective, non-inferior, randomized phase II clinical trial, to compare the~     efficacy and safety profiles of DA versus DAC as adjuvant chemotherapy regimens for~     early-stage breast cancer patients.~   "
16741|NCT02838212|"~     The purpose of this study is to determine the incidence of drug-related deaths in a~     university hospital during the year 2015~   "
16742|NCT02838199|"~     The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR)~     with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with~     bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with~     symptomatic severe aortic valve stenosis.~   "
16743|NCT02838186|"~     The aim of this study is to evaluate the examination of the proximal colon with the~     retroflexion colonoscopic technique in terms of feasibility and its possible additive~     contribution in the detection of important lesions, namely polyps and cancers.~   "
16744|NCT02838173|"~     This study compare the Serratus block plane (SPB) and the local infiltration of the tissue~     in the prevention of acute and chronic pain after breast cancer surgery.~   "
16745|NCT02838160|"~     A randomized controlled triple blinded clinical trial with repeated measurements. The~     reporting of this study complies with the CONSORT (Consolidated Standards of Reporting~     Trials) statement for trials of non-pharmacological treatments.~      The first aim of the study was to evaluate the effectiveness of the three competing~     interventions on the critical care nurses' knowledge of, attitudes toward and adherence to~     17 ventilator bundle components; the second aim was to determine the effectiveness of~     adherence to 17 ventilator bundle components with pre-defined ventilator bundle on the~     psychological factors of critical care nurses including nurses' stressors in intensive care~     unit (ICU), perceived stress, trait and state anxieties; the third aim was to evaluate their~     impact on the clinical outcomes; and the fourth aim was comparing KAP and psychological~     factors with clinical outcomes.~   "
16746|NCT02838147|"~     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance first diagnosed~     during pregnancy [1]. It is associated with adverse pregnancy outcome for the mother, and~     the fetus with consequences regarding future health and development of the neonate. Maternal~     consequences include increased rate of operative and cesarean delivery, hypertensive~     disorders during pregnancy and future risk for type 2 diabetes mellitus (T2DM) as well as~     other aspects of the metabolic syndrome, such as obesity, cardiovascular morbidities and~     recurrent GDM [2-4]. Also, children born to mothers affected by gestational hypertension~     have been found to have higher body mass index (BMI), systolic blood pressure, glucose and~     insulin levels [5]; this risk extends into adulthood, with an 8-fold increased risk of type~     2 diabetes among young adults exposed to gestational diabetes during fetal life [6].~      Of all types of diabetes, GDM accounts for approximately 90-95% of all cases [4, 7]. It~     complicates up to 14% of all pregnancies. Its prevalence is increasing and parallels the~     rising incidence of type 2 diabetes mellitus worldwide [3,4]. Risk factors for developing~     GDM in pregnancy include obesity, previously GDM, glycosuria, family history, ethnicity and~     hypertension [5,6].~   "
16747|NCT02838134|"~     Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the~     consequences of postoperative pain and analgesia consumptions. The investigators' goal is to~     establish the relationship between the use of deep neuromuscular blockade (NMB) during~     laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the~     investigators designed a trial in which patients scheduled for living donor nephrectomy are~     randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will~     be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.~   "
16748|NCT02838121|"~     Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy~     under mechanical unloading after THR implantation, further compromises the longevity of~     implant. The prospective randomized study is aimed to investigate the periprosthetic bone~     loss after primary total hip replacements.~   "
16749|NCT02838108|"~     This is an observational study examining outcomes and treatment patterns in a~     community-based cohort of subjects with Chronic obstructive pulmonary disease (COPD) who are~     based in the Kannapolis, NC area.~   "
16750|NCT02838095|"~     To examine the neurobehavioural responses to two successive cycles of sleep restriction and~     recovery in adolescents, and to determine the benefits of napping on cognitive performance,~     alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and~     no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15~     days. The nap group received an afternoon sleep opportunity lasting 1 hour.~   "
16869|NCT02836535|"~     The purpose of this study is to understand the patient experience with an adverse event~     after surgery. An adverse event is an undesirable experience or complication associated with~     your surgery.~   "
16753|NCT02838056|"~     Traditionally, placement of the epidural catheter is based on hand feel of passing through~     the ligamentum flavum as well as loss of resistance while injecting the air through the~     needle. However, both are subjective and not necessarily encountered consistently. Moreover,~     the onset of sensory block is usually slow, thus making confirmation of catheter position a~     tough task and may delay the turnover of the operating room. The only way to confirm the~     catheter position objectively without delaying surgery is to find a reliable indicator~     within minutes of local anesthetic injection. In this study, we try to use the change of~     temperature in the big toe as a surrogate indicator of correct epidural catheterization.~   "
16754|NCT02838043|"~     This study will be an 8-week open-label pilot study examining subjective and objective~     changes in mood, anxiety, cognition, and sleep before and after the introduction of a~     probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10~     treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to~     examine the full composition of the micro biome, the investigators will also be collecting~     and analyzing fecal samples as well as blood samples to examine changes in plasma levels of~     inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying~     mechanisms of any changes seen.~   "
16755|NCT02838030|"~     Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World~     Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher~     in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that~     preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality.~     Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so~     far there is no effective treatment to decrease the morbidity and mortality of this entity,~     so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in~     addition to the information the investigators have reduced the effect of these strategies on~     arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in~     this population. It is for this that is of interest to know the efficacy and safety of the~     combination of L-arginine low dose, which is known as an important eNOS in NO production~     substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the~     prevention of preeclampsia and also determine their effect on arterial stiffness as a~     noninvasive method, as is the applanation tonometry.~   "
16756|NCT02838017|"~     The goal of this project is to identify a strategy to reduce wound complications in women~     who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel~     skin incisions are closed by subcuticular sutures followed by either placement of~     Steri-Strips or Dermabond. Either Steri-Strips or Dermabond can be placed over the wound as~     a covering but it is unclear which may reduce wound complication rates. The hypothesis of~     this study is that Dermabond will result in a reduction in wound complication rates when~     compared to Steri-Strips. Previously published studies in non-obstetric populations have~     identified Dermabond as a potential intervention to reduce wound complications. The eligible~     population for this study will include women at NorthShore University HealthSystem Evanston~     Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean~     delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive~     either Steri-Strips or Dermabond. The primary outcome to be evaluated will be wound~     complication which will include wound infection (cellulitis or subcutaneous infection),~     wound separation (partial or complete), wound seroma/hematoma. Secondary endpoints to be~     investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference~     in total time for application.~   "
16757|NCT02838004|"~     This is an interventional, non-controlled, multicenter international trial with a~     prospective design on one cohort of patients.~   "
16758|NCT02837991|"~     This is a study to determine the safety of CDX-014 and effectiveness (how well the drug~     works).~   "
16759|NCT02837978|"~     This study is designed to observed prospectively the efficacy and safety of 6 months~     treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA~     patients who shown insufficiency response or intolerance to DMARDs~   "
16760|NCT02837965|"~     The study is an observational, multi-center, prospective, non-interventional and open-label~     data collection study assessing outcomes, treatment patterns, adverse events and costs in~     patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year~     with a follow-up (observation period) of 1 year for each patient. Four dermatology centres~     in France will participate. The hypothesis to be answered by the study is that superpotent~     topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world~     life as recommended by French guidelines and whether this treatment influences the medical~     costs by comparison with systemic therapies (e.g. methotrexate or prednisone).~   "
16761|NCT02837952|"~     This study is being conducted to determine the overall analgesic efficacy and safety of a~     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in~     subjects who are experiencing post operative pain following surgical extraction of 3 or more~     third molar teeth. A review of any reported adverse events will also be completed.~   "
16762|NCT02837939|"~     This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes~     homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs,~     chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections~     in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..~   "
16763|NCT02837926|"~     The study aims to identify global and local determinants of HPV vaccine acceptability, HPV~     vaccine uptake and compliance as well as identify logistics and programmatic issues in each~     country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to~     mid-aged women attending screening.~   "
16772|NCT02837809|"~     The MILD project is a randomized lung cancer screening trial whose primary aim is to~     evaluate the impact on mortality of early lung cancer detection through LDCT (low-dose~     computed tomography) in 2 groups: a control group undergoing a program of primary prevention~     with pulmonary function test evaluation and a group undergoing a periodic spiral CT~     associated with primary prevention and pulmonary function test evaluation. This last one is~     also randomized in two arms: yearly low-dose CT vs CT every 2 years.~      MILD trial comprehensive design combines for the first time primary prevention (smoking~     cessation) with early detection, and molecular risk profile through assessing the value of~     blood and tissue biomarkers.~   "
16764|NCT02837913|"~     The primary aim of the current study will be to determine if the use of an underbody heating~     mattress during cesarean sections will decrease the incidence of postoperative hypothermia,~     defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia.~     As part of the primary outcome the difference in the incidence of shivering, its severity,~     and need for treatment will be investigated. As a secondary goal other maternal~     perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level~     on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound~     infections, length of hospital stay, maternal satisfaction, time to first breastfeeding,~     time to first 'skin to skin' contact. The relationship between maternal hypothermia and~     newborn outcomes of temperature and APGAR scores will also be evaluated.~      Active preoperative and intraoperative warming may prevents inadvertent perioperative~     hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The~     underbody warming mattress may be a step towards finding a suitable form of warming that is~     comfortable for awake patients, does not interfere with skin to skin contact and~     maternal-fetal bonding.~   "
16765|NCT02837900|"~     The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy~     of a second course of TPX-100 administered by intra-articular injection to subjects with~     osteoarthritis of the knee who participated in study TPX-100-1.~   "
16766|NCT02837887|"~     This randomized clinical trial studies how well a computerized cognitive behavior therapy~     program works in treating depression in patients with cancer. The cognitive behavior therapy~     program uses a series of internet-delivered sessions intended to help patients identify and~     change problematic patterns of thinking and behavior that maintain depression.~   "
16767|NCT02837874|"~     Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer.~     The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of~     dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to~     gastric stasis or obstruction. The investigators will assess complications, dumping syndrome~     and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for~     gastric cancer.~   "
16768|NCT02837861|"~     A randomized, parallel-group, pilot study comparing the effect of the early addition of~     intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated~     alone immediately post traumatic injury.~      Primary: To determine that early and adequate nutritional support will improve protein~     economy in the first week post -injury as measured by nitrogen balance. We hypothesize that~     an improvement in nitrogen balance with early maximized protein intake will support the~     production of acute phase proteins, major antioxidants and the inflammatory response.~      Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR)~     technologies we will determine that our plan for early and adequate nutritional support with~     adequate protein from day one post injury will alter the metabolomics profile when compared~     to routine nutritional support.~      Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines~     and soluble proteins.~   "
16769|NCT02837848|"~     Rotator cuff tendinopathy (RCT) is the most frequent cause of shoulder pain. RCT is~     frequently termed as impingement syndrome, based on the underlying mechanism in which the~     subacromial space soft tissues (subacromial bursa, rotator cuff tendons and long head of the~     biceps tendon) get encroached under the coracoacromial arch when the arm is elevated. RCT~     contributes in the decrease in quality of life and function, and in inducing work~     incapacities and sleep disorders.~      Exercises, as conservative management, were shown to be effective in increasing function and~     in decreasing pain related to RCT. However, the lack of studies comparing different types of~     exercises (i.e. concentric, eccentric, scapular strengthening, proprioceptive, coactivation)~     is reported by many systematic reviews. One type of exercise, coactivation strengthening,~     could be more efficient. Coactivation strengthening implies a recruitment of the pectoralis~     major and the latissimus dorsi while performing regular strengthening. When theses muscles~     are recruited, the medio-inferior orientation of their tendons creates a force vector that~     limits the superior translation of the humeral head, thus limits the subacromial narrowing.~      The aim of this study is to evaluate the efficacy of coactivation strengthening exercises in~     patient with RCT compared to regular strengthening exercises. Forty-two participants~     diagnosed with RCT by an orthopaedic surgeon following a standardized protocol will be~     randomised to either coactivation or regular strengthening exercises. Participants will~     perform a 6-week exercise protocols. Outcomes will be measured at baseline, and at three,~     six, 12, 18 and 24 weeks. The primary outcome is function assessed with the Disabilities of~     arm, shoulder and Hand (DASH) questionnaire. Secondary outcomes focus on pain (visual analog~     scale), quality of life (Western Ontario Rotator Cuff Index), impression of change (Patient~     Global Impression of Change), subacromial distance (ultrasonography) and muscular strength~     (manual dynamometer). Investigators expect that coactivation strengthening exercises will be~     more efficient over the short and long term.~      This trial will provide data to guide clinicians in the treatment of RCT to reduce recovery~     time and to bring patients back as quickly as possible to work or usual function.~   "
16770|NCT02837835|"~     Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect.~     Numerous arguments are in favor of continuous administration of ceftazidime, both for~     reasons of clinical efficacy and to preserve bacteriological mutation. The investigators~     report a prospective, single-center, parallel-group, randomized, controlled trial comparing~     two modes of administration of ceftazidime, namely, continuous administration (loading dose~     of 20 mg/kg of body weight followed by 60 mg/kg/day) versus intermittent administration (20~     mg/kg over 30 min every 8 h) in 34 patients with ventilator-associated pneumonia due to~     Gram-negative bacilli. The study was performed over 48 h with 13 and 18 assessments of serum~     ceftazidime in the continuous-infusion group (group A) and the intermittent-fusion group~     (group B), respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both~     groups at 44 h to determine ceftazidime levels in the epithelial lining fluid. The~     investigators chose a predefined threshold of 20 mg/liter for serum concentrations of~     ceftazidime because of ecological conditions in our center.~   "
16771|NCT02837822|"~     It's well known that Spinal cord stimulation (SCS) changes the perception of chronic pain in~     the area stimulated by epidural electrodes. However, we don't know the effect of this type~     of stimulation on the perception of external sensations (temperature, touch, pressure, and~     vibration) and sharp pain. Quantitative sensory testing (QST) is used to quantify~     somatosensory phenotype. This QST battery tests different subtypes of nerve fibres (Aβ, Aδ~     and C) involved in the transduction of sensory information from the periphery to the spinal~     cord.~      The purpose of this study is to evaluate the effects of the SCS on sensory perceptions of~     patients with chronic pain (CRPS, FBSS). Sensorial perception tests will be carried out in~     accordance with a standardized procedure (Rolke et al. Pain, 2006). For non-implanted~     patients, an initial visit will be conducted before the operation. For all participants, two~     other visits will take place at least 6 months after the operation to perform the tests with~     and without stimulation.~   "
16779|NCT02837718|"~     Background Peripheral nerve blocks with use of USG allowed visualisation of the structures~     and nerves and made the block administrations safe, quick and comfortable. However there are~     few publications concerning the minimum local anesthetic volume capable of providing blocks.~     In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic~     For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.~      Materials & Methods A total of 55 ASA I-II patients underwent hand surgery operation by~     administering USG guided-axillary brachial plexus blockage were included in the study.~     Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume~     was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the~     blockage, volume was decreased by 0.5 for each nerves. Block administration time, block~     onset times, anesthesia times and time to first analgesic requirement were recorded.~   "
16780|NCT02837705|"~     The human Prion diseases can be classified into sporadic, acquired and inherited forms.~     Inherited forms usually manifest in higher age so there have to be factors preventing Prion~     propagation in young mutation carriers. Antibodies against the flexible tail of Prions have~     been shown to be protective in mice. The investigators intend to screen mutation carriers~     and controls for the presence of Prion autoantibodies.~   "
16781|NCT02837692|"~     The purpose of this study is to assess the pharmacokinetics of single-dose evening~     administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and~     gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of~     single-dose evening administration of JNJ-42847922 in healthy Japanese adults.~   "
16782|NCT02837679|"~     The study is a randomized study of patients living in four municipalities in Eastern~     Jutland. After geriatric assessment half of the patients will be offered a tailor-made~     intervention in their homes. The follow-up will last for at least 90 days and include~     treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and~     malnutrition. The other half of the patients, the results of the assessment and~     recommendations will be given to the patients and their general practitioner.~      The primary efficacy variables are accomplishment of planned cancer treatment, reduction of~     complications and admissions to hospital and increased quality of life,.~      If geriatric assessment and a tailor-made follow-up result in a better quality of life with~     less complications and admissions the offer may be extended to a longer period, younger age~     groups and other cancer diagnoses.~   "
16783|NCT02837666|"~     The purpose of this study is to demonstrate that Spirulina maxima intake and a dosed~     physical activity program will decrease, both independently and synergistically,~     cardiovascular risks (Dyslipidemias and oxidative stress) in overweight and obese subjects.~   "
16784|NCT02837653|"~     Objective: To determine the influence of a counseling of physical activity (PA) versus usual~     care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back~     pain (CLBP).~      Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups:~     an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted~     of 32 participants and were evaluated twice (pre and post-intervention), being spaced one~     month, both groups received telephone follow-up for their participation. The primary~     endpoint was the magnitude of the (CP) measured by the tool grading scale of chronic pain~     (EGDC), while as secondary were considered the cardiovascular risk factors, catastrophism,~     kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).~   "
16785|NCT02837640|"~     The purpose of this study is to evaluate the effect of L-Dopa on the progression of~     retinitis pigmentosa.~   "
16786|NCT02837627|"~     Due to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm~     infants. To limit the potentially harmful widespread of pharmacological treatment, a~     step-wise approach, which firstly undertakes conservative strategies, is currently~     considered the best choice to manage GER in the preterm population. Among the most common~     conservative strategies, postural measures seem to effectively reduce GER features in~     symptomatic preterm babies, whereas feed thickening is almost ineffective.~      Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate~     sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral~     intakes. Continuous feeding and boluses are the most common techniques of enteral tube~     feeding in Neonatal Intensive Care Units; at present, however, the effects of these~     techniques on GER features have not been clearly established.~      This observational, prospective and explorative study primarily aims to evaluate the effect~     of different techniques of enteral tube feeding on GER frequency and features in symptomatic~     preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple~     intraluminal impedance (pH-MII) for GER evaluation.~   "
16787|NCT02837614|"~     The study composed of sixty patients, each of whom required surgical extraction of a single~     impacted mandibular third molar under local anaesthesia. The patients were randomly~     allocated to one of 3 groups of 20 each. The three groups were categorized as Group A~     (intramuscular dexamethasone), Group B (submucosal dexamethasone) and Group C (control). The~     objective measurements of facial pain, swelling, and trismus was performed by an independent~     examiner at baseline (preoperatively), and at days 1, 3, and 7 postoperatively.~   "
16788|NCT02837601|"~     A prospective, randomized, controlled single-center clinical Study designed to evaluate~     Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS)~     at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be~     randomized in a 1:1 treatment device to control ratio into one of two (2) different study~     arms:~        1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or~        2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.~   "
16789|NCT02837588|"~     -  Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS~        -  MJS electrode is effective for transvaginal treatment at pelvic pain patients~        -  Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment~   "
16790|NCT02837575|"~     The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA~     vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).~   "
16870|NCT02836522|"~     The purpose of this study is to finalize development of a questionnaire that measures~     health-related symptoms and concerns for persons diagnosed with, and either treated or~     monitored for, anal pre-cancer lesions.~   "
16791|NCT02837562|"~     The goal of the present study is to evaluate the prevalence of radiation-associated lens~     opacities among interventional cardiology staff members (such as physicians, technicians,~     and nurses) and determine its association with occupational history.~      The hypothesis of the study is that interventional cardiology staff will have high~     prevalence of radiation-induced lens opacities, which will be higher than non-interventional~     cardiology staff and will correlate with the estimated cumulative lifetime dose.~   "
16792|NCT02837549|"~     The purpose of this study is to determine the feasibility and preliminary effects of a novel~     treatment approach to improve arm function in patients with scleroderma who have upper~     extremity contractures. It is a Phase 1, one arm trial in which participants will be~     assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8~     individual sessions with an occupational therapist. Feasibility of the procedures is a major~     focus of this project.~   "
16793|NCT02837536|"~     The goal of this study is to evaluate the agreement between intraocular pressure (IOP)~     measurements taken by iCare, held in both vertical and horizontal positions. In addition,~     iCare measurements will be compared against pneumotonometry measurements to assess for~     accuracy.~   "
16794|NCT02837523|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Cystinosis~     disease from plasma.~   "
16795|NCT02837510|"~     This study will examine how abstinence-induced brain changes contribute to smoking cessation~     outcomes in treatment-seeking smokers.~   "
16796|NCT02837497|"~     Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality~     cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective~     of this study is to determine if a novel patient-centric resuscitation care improvement~     bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac~     arrest improves CPR quality and survival outcomes in a multi-center trial.~   "
16797|NCT02837484|"~     This study was designed to evaluate the long term effectiveness of a product used in knee~     surgery called Affinity™ Membrane.~   "
16798|NCT02837471|"~     The purpose of this prospective randomized controlled trial (RCT) is to evaluate the~     feasibility and usability of a commercial pedometer and web application in a case-managed~     home-based Cardiovascular disease prevention and rehabilitation program for French-speaking~     Canadians.~   "
16799|NCT02837458|"~     The purpose of this study is to determine whether the transcutaneous application of~     unmodulated 30 Kilohertz (KHz) alternating currents could produce a quickly conduction block~     and if the pain of whiplash patients decreased.~   "
16800|NCT02837445|"~     The purpose of this double blind randomized study is the evaluation of the safety and~     efficacy of the Moderato System. The Moderato pacemaker is indicated for patients who~     require a dual chamber pacemaker and also have hypertension, in order to reduce their blood~     pressure.~   "
16801|NCT02837432|"~     There is good evidence to suggest that the pathological version of sadness that people with~     Major Depression experience could be caused by the failure of the hormone cortisol to~     properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This~     project investigates if the subgenual cingulate cortex has become insensitive to cortisol in~     patients with depression and tests for variants of the cortisol receptor genes that could~     predispose individuals to develop cortisol insensitivity.~   "
16802|NCT02837419|"~     This study evaluates patients on ECLS treatment as considered appropriate with mortality and~     health related Quality of life and costs.~   "
16803|NCT02837406|"~     The aim is to evaluate a national health information technology-based program to improve~     healthcare coordination and access to information.~   "
16804|NCT02837393|"~     The investigators objective is to determine if urinary electrolyte abnormalities exist in~     only one or both kidneys in participants with and without a history of kidney stones. To~     meet this objective, the investigators are going to take urine samples from each kidney at~     the time of kidney stone surgery. The samples will then be analyzed for absolute and~     relative differences in the concentrations of urine electrolytes, such as calcium.~   "
16805|NCT02837380|"~     This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of~     100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese~     subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in~     Chinese healthy population when administered using dry powder inhaler (DPI)as a blended~     combination of UMEC/VI in one strip and FF in the second strip in dose combinations of~     100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/~     Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of~     inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and~     inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be~     enrolled in the study. After taking into account the allowable time windows for screening,~     treatment and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.~   "
16806|NCT02837367|"~     The NutriGen project will be using nutrigenomic methods to determine the effectiveness of~     treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic~     signature) of obese individuals.~   "
16807|NCT02837354|"~     The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65~     years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI~     studies of these infarcts are rare. They are described as punctate, cortical silent.~     Frequency and pathophysiology is poorly understood. The investigators put the question of a~     link with hemorrhagic lesions of the AAC.~   "
16808|NCT02837341|"~     Respiratory rate as an important predictor for adverse events, but still a neglected vital~     sign.~      Precise and simple measurement of the respiratory rate in volunteers by a new electronic~     camera device in different settings.~   "
16809|NCT02837328|"~     The primary objective of this research is to determine whether oral magnesium~     supplementation in healthy, community-living individuals will be associated with reductions~     in the burden of arrhythmias in the upper chambers of the heart (supraventricular~     arrhythmias).~   "
16810|NCT02837315|"~     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session~     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use~     and drug-related consequences in college student~   "
16811|NCT02837302|"~     Protein-calorie malnutrition is frequently observed in patients with advanced liver~     cirrhosis. There have been continued interests in potential benefits of long-term oral~     branched-chain amino acid supplement in improving severity of liver disease. However, there~     are limited evidences in literature. The aim of this study is to evaluate the efficacy of~     oral branched-chain amino acid in patients with advanced liver cirrhosis.~   "
16812|NCT02837289|"~     Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius~     influence the mechanics of patellofemoral joints through increased dynamic knee valgus and~     can lead to Patellofemoral Pain Syndrome (PFPS). Mechanoreceptors can be stimulated by an~     elastic tape, which sends desired tactile cues via afferent improving the functional support~     of the musculoskeletal system.~      Objective: To analyze the response to hip stabilizer muscle activation in street runners~     with PFPS through the application of elastic tape therapy.~      Methods: The investigators evaluated street runners between the ages of 18 and 45, who run~     at least 5km/week and had been suffering from pain for at least 3 months. The volunteers had~     been assessed in relation to their measurements, experience of pain and training routine,~     their medius muscle (GM) and biceps femoris muscle (BF) had also been tested with surface~     electromyography through pre-determined performance tests. The participants of both groups~     wore a bandage for 6 weeks (1 per week). However for the participants of the placebo group~     the investigators applied a different anatomical path without tension, eliminating all the~     therapeutic elements. The volunteers were reassessed following the trial.~      Hypothesis: Expected to observe that elastic tape therapy do result in any improvement in~     the activation of hip muscles and improvement of pain in street runners with patellofemoral~     pain syndrome.~   "
16813|NCT02837276|"~     This pilot study aims at investigating the relationship between intermittent hypoxemia (IH)~     and acute kidney injury (AKI) in preterm infants.~      AIM 1: Test the hypothesis that intermittent hypoxemia is associated kidney injury in~     preterm infants, as reflected by a rise in serum creatinine.~      AIM 2: Test the hypothesis that there is rise in acute kidney injury urinary biomarkers with~     increased intermittent hypoxemia.~   "
16814|NCT02837263|"~     The purpose of this research study is:~        -  To find out how safe the study drug, pembrolizumab, is when combined with stereotactic~          body radiotherapy (SBRT) to the liver.~        -  To see how well subjects can tolerate treatment with pembrolizumab and SBRT.~        -  To find out how often colorectal cancer comes back 1 year after surgically removing all~          known disease and being treated with SBRT and pembrolizumab.~   "
16815|NCT02837250|"~     RECRUITING NOW AT www.pos4health.org~      This project has developed a patient-centered eHealth intervention; specifically, an~     Internet intervention, targeting multiple issues and nonadherence in HIV. The intervention,~     Pos4Health, includes peer role model videos and evidence-based interactions to promote~     understanding, coping with, and managing risk factors for nonadherence to ART, and to~     improve nonadherence itself. In this Pilot Trial, investigators will test the eHealth~     intervention Pos4Health with PLWH who reside outside urban centers.~   "
16816|NCT02837237|"~     This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney~     Disease (CKD) (including patients with severe renal impairment and those on hemodialysis~     [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of~     KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular~     filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification~     of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.~   "
16817|NCT02837224|"~     Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently~     reported serious adverse event for five of the last six years. Retained surgical sponges~     have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital~     stay, infection, fistulas/ bowel obstructions, and death). The national standard for~     prevention of retained surgical sponges relies heavily on manual counting several times~     before, during, and after the surgical procedure. If a sponge is missing, a series of steps~     are taken to reconcile the count. These steps require extra time and pull personnel away~     from other competing priorities. If the final closing count remains incorrect, it is common~     practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge.~     This X-Ray is expensive and increases the time required for the surgery.~      Novel technology using a radiofrequency (RF) is now available for detecting and preventing~     retained surgical sponges. The objective of this study is to evaluate the in-use~     effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the~     cost of searching for sponges and prevention of incorrect counts.~   "
16818|NCT02837211|"~     TREND is a pilot randomized trial comparing two alternative methods of initiating a~     low-calorie weight loss diet. The study will compare the traditional diet initiation of~     abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus~     a 6 week tapering of energy intake from a baseline level. These two approaches will be~     compared with respect to their impact on energy regulatory systems of the body, weight loss~     and other measures, up to a year after diet initiation.~   "
16819|NCT02837198|"~     To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of~     FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or~     uric acid-underexcretion type.~      In addition, to investigate the additive effects of the combination of FYU-981 and~     topiroxostat administered orally to male hyperuricemic patients with uric~     acid-overproduction type.~   "
16820|NCT02837185|"~     This study will look into the effects of Botulinum Toxin in patients with primary cervical~     dystonia. The effects will be determined by neck muscle activity measurements and brain~     function activity measurements. The goal of the study is to try to identify markers of the~     effects of Botulinum toxin.~   "
16821|NCT02837172|"~     This project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive~     method to improve early diagnosis of Parkinson's disease (PD). Two populations will be~     evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan,~     and 2) individuals with well characterized PD and healthy controls, drawn from the fully~     enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.~   "
16822|NCT02837159|"~     The purpose of this randomized study is to assess the efficacy of a mobile application for~     the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors~     (CCR).~   "
16825|NCT02837120|"~     Acute non-traumatic chest pain is a common kind of symptom in extremely critical condition,~     with various pathogenesis and different level of risk . Chest pain in high risk takes 1/3 of~     that. It mainly includes acute coronary syndrome (including myocardial infarction and~     unstable angina pectoris, accounted for over 95% of chest pain in high risk), aortic~     dissection, pulmonary embolism etc, and is in high lethality and deformity.~      The investigators do the research :~        1. To study the diagnosis and management condition of acute chest pain in extremely~          critical condition for last ten or more years in Qilu Hospital,Shandong University.~        2. To discuss the significance of key accompanying symptoms(for example radiating pain,~          chest distress, sweating, nausea etc), physical signs and lab examination in early~          diagnosis and risk stratification of acute chest pain in extremely critical condition.~        3. To study the effect factors of thrombus burden in STEMI patients, at the same time,~          creat a a simple, practical and scientific method of blood clots classification.~   "
16826|NCT02837107|"~     While it is well accepted that a low level of RONS production is necessary to maintain~     physiological function, too much formation of RONS are believed to participate in~     biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level,~     as a consequence of oxidative stress has been linked to a number of serious diseases,~     including cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis,~     neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes~     and the process of aging.~      The dietary intake of antioxidants is thought to play a major role in oxidative stress~     network. Many epidemiologic studies have reported an inverse association between vegetable~     and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs.~     However, although many clinical trials have been conducted with vitamins (E, C or their~     combinations) their in vivo protective effect remains uncertain. Therefore the possibility~     that the complex mixture of phytochemicals in foods may contribute to their protecting~     effects has been raised. In this concept, it is possible multiple compounds to act through~     complimentary or synergistic mechanisms to present a greater biologic effect than can be~     achieved by any individual component To investigate this hypothesis, a double-blind,~     randomized, and placebo-controlled clinical trial was conducted in order to investigate the~     effects of a multi-micronutrient supplement against oxidative stress in apparently healthy~     adults.~   "
16827|NCT02837094|"~     The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3~     GNP peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every~     28 days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first~     dose). Treatment will be given into the arm at a volume of 50ul.~      No blinding or randomisation will be performed. In keeping with standard phase 1 study~     designs, no placebo or control group is included as the primary aim is to establish whether~     there are any major unexpected safety issues in the use of this IMP for the first time in~     man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.~   "
16828|NCT02837081|"~     Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial~     use, reduce bacterial resistance, unnecessary drug costs and enhance patient health~     outcomes. Two core strategies of ASP recommended as effective in guidelines are formulary~     restriction with drug preauthorization and prospective audit with feedback. Investigators~     will evaluate the effectiveness of the 2 strategies using antimicrobial utilization and~     patient outcomes.~   "
16829|NCT02837068|"~     The purpose of this study is to determine whether wheelchair handrail compensator plus~     rehabilitation training could do better than ordinary wheelchair plus rehabilitation~     training in relieving pain and improving daily life activity, upper limb motor function and~     quality of life for patients with hemiplegic shoulder pain.~   "
16830|NCT02837055|"~     It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for~     endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated~     camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation~     of the tube's passage through the vocal cords during intubation.~      Patients who are requiring urgent or endotracheal intubation in intensive care are~     randomized to receive either a conventional intubation with direct laryngoscopy or to~     receive intubation with the VivaSight-SL-Tube. Primary outcome measures are first attempt~     success rate and number of attempts to successful intubation.~   "
16831|NCT02837042|"~     Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in~     less developed countries. PSCC is a highly aggressive malignancy characterized by early~     spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will~     serve as the investigational agent for this penile cancer study.~   "
16832|NCT02837029|"~     The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest~     dose of the study drug nivolumab that does not cause unacceptable side effects, for~     combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to~     evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of~     the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere).~     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but~     has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab~     is an antibody (a human protein that sticks to a part of the tumor and/or immune cells)~     designed to allow the body's immune system to work against tumor cells. Y-90 is currently~     FDA approved for the treatment of hepatocellular carcinomas, but has not yet been~     investigated in combination with nivolumab for this disease.~   "
16871|NCT02836509|"~     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for~     the pain treatments.~      The objective of the study was to assess whether intravenous Paracetamol has superior Low~     Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults.~      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.~   "
16875|NCT02836457|"~     The primary objectives of this study is to estimate the real-world safety profile of Eliquis~     in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to~     affect the incidence of bleeding. Lastly, the secondary objective of this study is to~     estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism~     patients.~   "
16833|NCT02837016|"~     The investigators propose a randomized controlled trial (RCT) to investigate the feasibility~     and efficacy of non-intrusive biofeedback devices that can be worn throughout the day in~     providing therapeutic cues to college students suffering from chronic anxiety. The~     biofeedback device detects physiological stress indices in real time (e.g., changes in~     breathing rate) and provides feedback (e.g., through minor vibration or text messages)~     serving as a cue to the wearer to recall therapeutic steps at exactly those moments they~     need to exert cognitive control. Students will be randomized in a 1) experimental group with~     biofeedback device and 2) experimental group without biofeedback device. Experimental groups~     will undergo an intervention that will strengthening cognitive control through~     mindfulness-based relaxation techniques. Outcome measures will include a multi-method~     approach collecting questionnaire, behavioral, neuro-scientific, and psycho-physiological~     indices of anxiety and self-control. The proposed study is innovative and has the potential~     to lead to more effective and cost-efficient types of intervention applications in the~     future.~   "
16834|NCT02837003|"~     To evaluate safety of reduction of dual antiplatelet therapy period to three months after~     implantation of Ultimaster sirolimus-eluting stent (U-SES).~      Additionally to investigate appropriateness of thienopyridine monotherapy with~     discontinuation of aspirin.~   "
16835|NCT02836990|"~     This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision~     Management System versus Dermabond in preventing groin wound infections in patients who~     undergo vascular surgery requiring a groin wound. Half of the patients will receive~     Dermabond and the other half will receive the Prevena Incision Management System for their~     groin wounds.~   "
16836|NCT02836977|"~     Primary Objective:~      To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant~     oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in~     patients with stage III colon cancer after radical resection.~      Secondary Objectives:~        -  To assess 5-year overall survival (OS) in each arm~        -  To assess the safety profiles~   "
16837|NCT02836964|"~     To evaluate the clinical success, stability, radiographic bone level changes and~     peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns~     restorations in early loading in the mandibular first molar region.~   "
16838|NCT02836951|"~     Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal~     models. The objective of this study is to find whether similar markers are detectable in the~     body fluids of human subjects that have sustained a TBI.~   "
16839|NCT02836938|"~     It's the aim of this study to clarify, whether the non-invasive assessment of breath can~     serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of~     BOS can be discriminated by the level of certain VOCs than there would also be a potential~     to actually predict the development at an early stage and would enable an earlier~     intervention.~   "
16840|NCT02836925|"~     This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus~     ledipasvir ± ribavirin (genotype 1, 3 and 4) or sofosbuvir + ribavirin (genotype 2) for~     patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).~   "
16841|NCT02836912|"~     Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive~     pulmonary disease (COPD). However, merely 30% patients know how to do the exercise~     correctly. Therefore, it is worthy to investigate the applications in clinical practice. In~     addition, there are no relative research in Taiwan to see effects of an 8-week pulmonary~     rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with~     COPD.~   "
16842|NCT02836899|"~     The purpose of this study is to determine whether nitric oxide is effective in the treatment~     of acute kidney injury in cardiac surgical patients with endothelial dysfunction undergoing~     prolonged cardiopulmonary bypass.~   "
16843|NCT02836886|"~     This study will be using this technique, called VirCapSeq-VERT to analyze the white blood~     cells of patients with Sézary syndrome. This could provide the foundation for future studies~     looking to understand the role that viruses play in the origin of Sézary syndrome. This~     could have important implications for the future development of new and effective therapies~     for the disease.~   "
16844|NCT02836873|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and moderate~     renal impairment.~   "
16845|NCT02836860|"~     The purpose of this study is to compare combined tactile stimulation and verbal instruction~     to verbal instruction only on lumbar multifidus muscle activation in asymptomatic healthy~     adults and in patients with LBP.~   "
16846|NCT02836847|"~     The purpose of this study is to evaluate the feasibility, efficacy and safety of target~     therapy according to genomic and proteomic profiling combined with GEMOX in advanced or~     recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.~   "
16847|NCT02836834|"~     The primary objective is to assess the safety and tolerability of JS-001 in subjects with~     various advanced or recurrent malignancies, including solid tumors and lymphomas, and to~     evaluate its preliminary efficacy.~      The secondary objectives are to: 1) characterize the single-dose and multi-dose~     pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3)~     assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate~     biomarkers associated with the efficacy of JS-001.~      The exploratory objectives include to evaluate the consistency between biomarker detection~     results of archived tissue and fresh frozen tissue, and to assess the consistency of~     response using various response criteria (such as irRC, WHO, RECIST and irRECIST).~   "
16848|NCT02836821|"~     The primary purpose of this study is to investigate potential pharmacokinetic interaction in~     healthy volunteers when apatinib is administered in combination with rifampicin. Secondary~     objective is evaluating the safety and tolerability of apatinib alone and when~     co-administered with rifampicin.~   "
16934|NCT02835690|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with~     locally advanced or metastatic non-small-cell lung cancer (NSCLC).~      Cycle 1 is 28 days long; subsequent cycles are 21 days long.~   "
18016|NCT02821533|"~     The aim of the current study is to study the safety and effectiveness of TACE using a high~     dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and~     it improves the therapeutic effect of conventional TACE.~   "
16849|NCT02836808|"~     Abstract: Empowerment interventions for chronic diseases are an evolving process. No~     agreement exists regarding the necessary components and methodologies to be applied.~     Systematic reviews have assessed the effect of self-management interventions. Improvements~     in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In~     the long term, no major changes have been achieved in weight, physical activity, smoking~     status, and depression scores.~      There is a need for additional studies. The Center for Comprehensive Care of Patients with~     Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment~     techniques (using simple low-cost interactive tools) over a short period of time followed by~     at-distance support using internet or cell phone technology. The target population consists~     of patients with type 2 diabetes, free of chronic complications who are non-smokers. The~     intervention is composed of four monthly visits followed by a continuous at-distance support~     system. At each visit, patients stay for six hours in the center. Information is presented~     in group sessions. Empowerment techniques are applied during individual exchanges with the~     team or during facilitated group sessions. In summary, empowerment programs are an unmet~     need in many healthcare services.~   "
16850|NCT02836795|"~     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with advanced melanoma or urological cancers who have~     failed in routine systemic treatment. The study will be conducted in 2 parts: dose~     escalation and cohort expansion to investigate tolerability and efficacy.~   "
16851|NCT02836782|"~     New markers of viral activity are now under investigation. Aim of the study is to~     investigate the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in~     HIV-positive population. In HIV/HCV coinfected population, the study of HIV reservoir~     dynamics and the analysis of the prevalence of HCV resistance-associated mutations will help~     clinicians to improve the management of coinfected patients.~   "
16852|NCT02836769|"~     Although evidence exists to support cancer rehabilitation, services are fragmented and~     rehabilitation professionals are consulted infrequently and often long after treatment ends,~     when chronicity of problems limits the impact of intervention. Therefore, the objective of~     this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation~     Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and~     resources to meet those needs; to establish individualized rehabilitation goals for HNC~     survivors and personalized action plans to meet those goals; and to provide support to HNC~     survivors for the implementation and evaluation of action plans. This project consisted of~     intervention development and pilot evaluation; this trial registration describes the pilot~     evaluation phase only.~   "
16853|NCT02836743|"~     To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.~   "
16854|NCT02836730|"~     The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar~     disc herniation and 60-70% in patients with spinal stenosis.~      At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc~     herniation and spinal stenosis are treated by a multidisciplinary team comprising~     rheumatologists, physiotherapists, chiropractors, and social workers according to current~     guidelines. Therefore we have a unique opportunity to report the long term outcome in~     candidates for surgery, regardless of whether they have surgery or not, after having~     received optimal but unsuccessful nonsurgical treatment.~      The purpose of this study is to answer the following questions: 1) What is the proportion of~     patients operated upon after referral to surgical evaluation with positive MRI findings,~     persistent low back pain, and poor outcome following non-operative treatment? 2) What was~     the outcome in these patients 2 years following referral? 3) Where any baseline variables~     predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in~     patients with or without surgery?~   "
16855|NCT02836717|"~     The aim of this study is to determine the success rate, the success duration, the~     complication rate, maintenance effort and quality of life several years after sacral nerve~     modulation (SNM) treatment for constipation or stool incontinence.~   "
16856|NCT02836704|"~     Primary Objective:~      -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior~     to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one~     episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in~     overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs~     (OADs).~      Secondary Objective:~        -  To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.~        -  To evaluate the percentage and accumulated percentage of patients achieving fasting~          plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).~        -  To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).~        -  To evaluate the insulin doses change.~        -  To evaluate the weight change.~        -  To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia~          occurrence.~        -  To descriptively evaluate the safety profile.~        -  To assess patient and physician satisfaction and adherence (drop-out rate and the~          percentage of patients who can follow the treatment and insulin titration).~        -  Subgroup analysis on efficacy (control rate, control rate without confirmed~          hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:~        -  Age~        -  Duration of diabetes~        -  Baseline treatment (OAD)~        -  Baseline HbA1c, FPG and PP~   "
16872|NCT02836496|"~     Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is~     considered to play an important part in the pathology, including eosinophilic asthma, HES,~     and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood~     eosinophil counts is observed in association with mepolizumab administration, with~     concomitant clinical improvement. This is a 32-week treatment period, randomized,~     double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in~     adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This~     study will demonstrate the efficacy of mepolizumab compared with placebo based on~     maintenance of control of HES symptoms during the treatment period. The study will comprise~     of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment~     period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week~     additional follow-up period (12 weeks after the last dose of study treatment).~   "
16873|NCT02836483|"~     A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II~     Trial of LCB01-0371.~   "
16857|NCT02836691|"~     The autonomic nervous system (ANS) plays an important role in asthma, primarily through the~     parasympathetic (by the cholinergic pathway) promoting bronchoconstriction. Asthma is a~     chronic inflammatory disease, however, bronchoconstriction is not always caused by bronchial~     inflammation, as occurs in paucigranulocitic phenotype or noninflammatory asthma. The~     hypothesis of this project is based on the activation of the parasympathetic nervous system~     (PNS) would be involved in the pathogenesis of noninflammatory asthma (paucigranulocitic~     phenotype) and emotional stress and poor control of patients with severe asthma. To~     determine the ANS involvement in the pathogenesis of paucigranulocItic phenotype in asthma~     and correlate emotional stress, mediated by the ANS, with uncontrolled severe asthma. 30~     asthmatics with different clinical severity (mild, severe controlled and uncontrolled~     severe) will be recruited , along with a control group of 10 healthy people. Descriptive~     variables, spirometry, inflammatory parameters (FeNO and inflammatory cell count in induced~     sputum), blood, saliva, urine and hair to obtain stress markers (glucose, copeptin,~     prolactin, cortisol) will be collected, and be supplied validated questionnaires of asthma~     control, quality of life and stress. For monitoring the response of the ANS will be done~     through an electrocardiogram, recording the heart rate variability (HRV). This analysis is~     carried out with the collaboration of engineers specialized in the characterization of~     cardiovascular signals for measuring the ANS.~   "
16858|NCT02836678|"~     The effect of adding Nanobone on horizontal bone gain in ridge splitting.~   "
16859|NCT02836665|"~     After admission to the emergency room each dermatological patient is routinely assessed to~     Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for~     anamnesis followed by randomization in two equal study groups.~      Patients of group A (control group) wait routinely until the dermatological investigator in~     charge arrives at the emergency room. Once the dermatological investigator is on site, he~     gives a diagnosis and proposes a therapy.~      For Patients of group B (teledermatology) study-related photographs of the skin lesion and~     anamnesis data are uploaded to the hospital information system medico. Those data can~     directly be processed by the dermatological investigator in charge who enters his diagnosis~     and his therapy proposal.~      Subsequently an internal control is carried out as the same investigator comes personally to~     the emergency room to check its telemedical diagnosis and therapy proposal.~      Finally both time periods patients have to wait in the emergency room for their diagnosis~     and therapy are compared with each other.~   "
16860|NCT02836652|"~     This study is a prospective, multi-center, randomized, double-blind placebo-controlled study~     of subjects receiving the HM II LVAD as per the current FDA approved indications for use.~   "
16861|NCT02836639|"~     Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan)~     conditioning regimen for ASCT in non-Hodgkin's lymphoma~   "
16862|NCT02836626|"~     Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is~     estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to~     functional difficulties performing activities of daily living, pain with bowel movements,~     and pain with sexual activity . There is anecdotal evidence supporting the use of deep~     fascial scar mobilization techniques in reducing abdominal surgical scar pain, and yet~     almost no research has been published. The aims of this randomized clinical trial will be to~     determine if deep fascial scar mobilization techniques or superficial scar mobilization~     techniques will improve chronic pain and its resulting functional deficits, threshold~     pressure discomfort, pressure tolerance and mobility restrictions resulting from C-section~     surgery and to see if these interventions are more effective than no intervention. A~     positive result may result in an increase in the use of this intervention and thus the~     reduction of chronic scar pain for many women; it may provide justification for insurance~     reimbursement for this approach and it will also pave the way for further investigation into~     the use of these techniques with other types of painful scars including hysterectomy.~   "
16863|NCT02836613|"~     The main purpose of this study is to evaluate how much galcanezumab gets into the body after~     it is given as an injection just under the skin by two different devices. This study will~     measure how much galcanezumab reaches the blood stream and will test how it affects~     calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may~     occur will be collected. The study will last about 20 weeks for each participant. Screening~     is required within 45 days prior to the start of the study.~   "
16864|NCT02836600|"~     The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in~     Japanese participants with advanced solid tumors.~   "
16865|NCT02836587|"~     Fall related injuries are major health problem which effect especially elderly population.~     After experiencing a fall, most of the elderly are unable to resume their previous mobility~     and the fear of future falls affects their daily life. Falls in elderly population are often~     related to balance or gait problems. The aim of this study is to assess the influence of~     balance training on postural and motor control of healthy elderly participants. The study is~     designed as a parallel interventional study with experimental and control group (allocation~     ratio 1:1). Participants' general health, balance abilities, fear of falling and gait~     stability and variability will be assessed on the baseline measurement, right after and 2~     months after the completion of the training programme. Experimental group will undergo~     training focused on development of balance abilities and strength twice a week (60 minutes~     in length each) for 8 weeks. Participants will receive individualized exercises which will~     be focused on the main 4 types - stance exercises, gait and transition exercises and~     strength exercises especially focused on muscle strength of lower extremities.~   "
16866|NCT02836574|"~     The purpose of the present study is to compare the safety and efficacy of up to 2 injections~     of NKA given 3 to 6 months apart (maximum) in subjects who are randomized to receive their~     first treatment as soon as the NKA product is made available versus subjects who are~     randomized to undergo contemporaneous, standard-of-care treatment for CKD during the first~     12 18 months prior to receiving up to 2 injections of NKA.~   "
16867|NCT02836561|"~     The goal of this project is to investigate whether a pre-visit telephone intervention could~     increase awareness of long-acting reversible contraception (LARC) availability at the time~     of uterine evacuation.~   "
16868|NCT02836548|"~     This is a mono-center open-label proof-of-concept pharmacologic study to explore the~     efficacy and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant~     for BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors.~   "
16876|NCT02836444|"~     Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for~     epidemiological studies but are not adequate for inclusion of patients into therapeutic~     clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset~     is appropriate for stratifying lung severity and risk of death in ARDS patients. The~     investigators will perform an observational, non-interventional, multicenter, prospective~     audit in a network of intensive care units in Spain for evaluating the severity and risk of~     death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS~     diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of~     the study NCT02288949.~   "
16877|NCT02836431|"~     This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the~     blood when given by nasal spray. The study will help us determine the best dosing amount for~     children undergoing sedation or anesthesia with DEX.~   "
16878|NCT02836418|"~     ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the~     United States (US) and Europe who participated in the Study ATYR1940-C-003 (Stage 1 only) or~     ATYR1940-C-004 (i.e., the parent studies).~   "
16879|NCT02836405|"~     The main purpose is to study brain plasticity (the changes that occur in the brain through~     experience) in individuals with autism spectrum disorder (ASD). Research suggests that~     during development, the brains of individuals with ASD may change in response to their~     experiences differently than the brains of typically developing individuals. Investigators~     want to understand why and how this difference may contribute to the symptoms of ASD.~   "
16880|NCT02836392|"~     This is a translational, multicentre questionnaire study. The study design follows that of a~     cross sectional, quantitative research approach. Data collection will involve~     self-administered, paper-based questionnaires. The method of data collection allows for a~     large sample size without major expense. The questionnaires are comprised of several~     questions examining areas such as demographic details, cancer diagnosis, understanding of~     the term 'clinical trials', attitudes to personal participation in cancer clinical research~     and the experience of patients who previously participated in a cancer clinical trial. The~     study will be opened in all interested hospitals in Ireland following initiation of the~     study at each site. Questionnaire completion will be seen as implied informed consent and no~     formal consent will need to be signed by the patient. The paper-based questionnaire~     responses will be electronically and anonymously recorded in a computer database to~     facilitate analysis.~   "
16881|NCT02836379|"~     In the context of radiotherapy, control of breakthrough pain represents a special challenge.~     Patients undergoing radiotherapy may experience different situations of pain that may be due~     to the need to remain immobilized during radiotherapy session, the need to wear an~     immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation~     after the development of proctitis, or sudden pain during the night causing sleep~     disturbances.~      In a survey conducted in radiation oncology services more than half of patients treated with~     radiotherapy experienced pain, and 39% of patients reported that their pain was not treated~     properly. This situation may increase the patient's anxiety, dissatisfaction with treatment,~     affect their quality of life and can even come to refuse radiotherapy treatment.~      This post-authorization observational study will assess the quality of life of cancer~     patients with breakthrough cancer pain treated in radiotherapy services in Spanish~     hospitals.~   "
16882|NCT02836366|"~     With this study results of the Targon® PH+ nail, developed for the treatment of humeral head~     fractures, will be investigated clinically, radiological evaluation is optional. The primary~     objective of this study is to examine the effect of a plating treatment on the speed of~     recovery of functional capacity in adult patients. Secondary aims are to examine the level~     of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation~     and complications.~      Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by~     Aesculap~   "
16883|NCT02836353|"~     Surgery on the gastrointestinal (GI) tract results in profound changes to the metabolic~     profile. This is well described, including the rapid resolution of diabetes seen after~     bariatric surgery. The underlying pathophysiology, and incidence in lean patients undergoing~     surgery for cancer, is somewhat less described. The investigators plan to assess the~     symptomatic and glycaemic profile, as well as causative pathways, for metabolic symptoms in~     patients after surgery on the GI tract. The investigators will use glucose tolerance tests,~     physiological challenges with somatostatin analogues and antibiotics, and assess tissue~     transcriptomic changes.~   "
16884|NCT02836340|"~     Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac~     arrest (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die. As most~     patients die due to brain damage sustained during cardiac arrest and the subsequent~     reperfusion phase, effective neuroprotective strategies could potentially improve outcome.~     In animal experiments, 2-Iminobiotin (2-IB), a selective neuronal and inducible nitric oxide~     synthase (NOS) inhibitor, given upon reperfusion has been shown to improve memory function.~     Since 2-IB has not shown any safety issues in preclinical and clinical studies. Before~     embarking on large studies with efficacy as primary endpoint, safety, tolerability and~     pharmacokinetics need to be established.~      Objective: Evaluate short term safety and tolerability, and the pharmacokinetic properties~     of 2-IB in adult patients after OHCA.~      Study design: Phase 2, single-centre, open-label, dose-escalation intervention study.~      Study population: Three cohorts of eight evaluable patients admitted to the ICU after OHCA~     due to a cardiac cause.~      Intervention:~      The first eight patients will receive 0,055 mg/kg 2-IB every 4 hours intravenously, 6 times~     in total (part A). The second eight patients (cohort B) will receive 0,165 mg/kg every 4h~     iv, 6 times in total. The third eight patients (cohort C) will receive 0,5 mg/kg every 4h~     iv, 6 times in total. Medication has to be given as soon as possible and within 6h after~     OHCA. Escalation to the next dose level will only be done after pharmacokinetic analyses~     have performed, no relevant safety issues have been encountered, and the DSMB approves to~     move to the next dose level.~      Main study parameters/endpoints:~      Study parameters to evaluate short term safety and tolerability will be vital signs (heart~     frequency, blood pressure, cardiac ischemia) before and until 15 minutes after~     administration. (Serious) Adverse Events will be recorded on the ICU (up to 7 days) or until~     discharge from the ICU. For evaluation of the pharmacokinetics profile of 2-IB, 9 plasma~     samples will be analysed. Secondary parameters: Biochemical markers Neuron specific Enolase~     and s100b at 24h and 48h after start of study drug, occurrence of SAEs until 30 days after~     OHCA including death, long term term efficacy as determined by the Cerebral Performance~     Category (CPC), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) or~     the Telephone Interview Cognitive Status (TICS) scale at 30 days after OHCA.~   "
16967|NCT02835261|"~     The overall goal of this project is to test the hypothesis that long-term, sustained sleep~     restriction (SR), in women, will lead to increased cardio-metabolic risk. This will be~     characterized by increases in visceral adiposity, unhealthy lifestyle behaviors (poor~     dietary quality and low physical activity) and cardio-metabolic risk factors (blood~     pressure, glucose intolerance) relative to habitual sleep (HS). The investigators expect~     these changes to be worse in pre- compared to post-menopausal women.~   "
16885|NCT02836327|"~     To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and~     neuromyelitis optica spectrum disorders.~      The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white~     matter fiber tracts destruction , iron deposition and cerebral blood flow of associated~     regions in multiple sclerosis and neuromyelitis optica spectrum disorders using~     contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping,~     diffusion tension imaging, and arterial spin labeling with post labeling delay of 2.0~     seconds. Transfer constant volume , magnetic susceptibility, cerebral blood flow and~     fractional anisotropy(FA) value were measured in lesion and normal appearing white matter.~   "
16886|NCT02836314|"~     The aim of this split mouth, single-center, controlled study is to compare the healing of~     intrabony defects treated with a combination of Anorganic Bovine Bone Mineral~     (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis~     being tested in the study was that PRF would augment the regenerative effects of ABBM in~     human intrabony defects.~   "
16887|NCT02836301|"~     Investigators will evaluate organ donation educational videos with a 2x3 single blinded~     Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs).~     The testimonial video about Uncontrolled Donation after Circulatory Determination of Death~     (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live~     uDCDD footage, differing endings, or combinations. Video production will be informed by the~     entertainment education model and produced with experts including an Academy Award winning~     filmmaker. The primary outcome is whether participants immediately enroll in the NY State~     Organ Donor Registry (either online or by our RA mailing in the official form with prepaid~     postage). Investigators hypothesize that each video will induce differences in registration~     compared to the control and that there is an interaction effect with video genre and story~     outcome.~   "
16888|NCT02836288|"~     The primary purpose of this study is to see if it is safe to give patients with head and~     neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they~     receive radiation, chemotherapy, and/or surgery for their cancer treatment to treat~     depression and its effects. Researchers would also like to see if giving ketamine at the~     same time as cancer treatment is practical and reasonably acceptable to the patient.~      Depression has many negative consequences for outcomes in those with head and neck cancer.~     It causes delayed treatments, increases in hospital lengths of stay, decreases in treatment~     adherence, poorer self-care, and decreased quality of life, even at 3 years post treatment.~     The presence of depression is the number one predictor of incomplete treatment and~     difficulty with rehabilitation. Therefore, investigators would also like to see if it is~     feasible to give patients ketamine during their routine cancer treatment treat depression~     and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and~     quality of life. The study will also use a placebo to compare to the good and/or bad effects~     of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a~     liquid to be taken by mouth.~      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic~     by itself for some diagnostic and surgical procedures or combined with other general~     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered~     experimental in this study because it is not approved by the FDA for the treatment of~     depression.~   "
16889|NCT02836275|"~     Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian~     tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules'~     to classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple~     Rules give an inconclusive result and therefore a suitable second line test is necessary.~     Recently the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance~     Imaging (MRI) score system that focuses on ovarian tumors.~      The aim of this prospective study is to evaluate the performance of pelvic MRI examination~     with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING~     system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the~     prediction of malignancy). Other aims are the determination of the malignancy rate per~     ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the~     assessment of the accuracy of the specific diagnosis based on MRI images.~      The study is a multicenter prospective study. In centers where perfusion -and diffusion~     weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses~     based on ultrasound, the study is considered to be interventional. However, in other~     centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging~     can be standard of care. In these centres, the study can be considered to be observational.~      The IOTA-MRI project is linked to the IOTA study. In this multicenter study different~     diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass~     prior to surgery. This study allows to define a subgroup of patients in which Simple Rules~     are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI~     project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included~     consecutively, yet only after completing the informed consent. Recruitment will take 2 years~     of time as of the start of the individual center.~      The gold standard is the histopathology diagnosis of the mass within 120 days after~     ultrasound evaluation. The surgical approach is chosen by the managing clinician.~   "
16890|NCT02836262|"~     To evaluate effectiveness and safety of the HIT Hip Replacement System (HHRS) in patients~     undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using~     patient-reported, clinical, radiologic, and radiostereometric outcomes. Safety will be~     evaluated through the collection of device-related and unanticipated device-related adverse~     events.~   "
16891|NCT02836249|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive~     and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic~     hepatitis B virus (HBV) infection in China.~   "
16892|NCT02836236|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive~     and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic~     hepatitis B virus (HBV) infection in China.~   "
16893|NCT02836223|"~     This study evaluates the addition of an interdental cleaning device paired with a manual~     toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival~     bleeding and reduction of gingival inflammation.~   "
16894|NCT02836210|"~     To prospectively compare clinical outcomes using straight (perpendicular) versus angled~     trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane~      Primary Endpoints:~      Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS.~      Secondary Endpoints:~      Rate of postoperative wound-related complications such as hypotony, choroidal detachments,~     endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.~   "
18017|NCT02821520|"~     To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination~     with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).~   "
16895|NCT02836197|"~     Today, oncological care offers more effective and personalized treatments than ever before,~     while cancer patients and their physicians are increasingly confronted with uncertainty.~     Physicians may experience a lot of difficulties to simultaneously address this uncertainty~     with their cancer patients and to support their hope. Although previous studies reported the~     effectiveness of communication skills training designed for health care professionals (CST),~     specific training addressing uncertainty and hope in oncology have not yet been studied.~     This project aims to assess in a randomized study the efficacy of a 30-hour CST program~     addressing uncertainty and hope in oncology and designed for physicians. The efficacy will~     be assessed by analyzing physicians' acquisition of communication skills addressing~     uncertainty and hope in encounters with a simulated advanced stage cancer patient.~   "
16896|NCT02836184|"~     With calcium carbonate as the positive control drug, to observe the effectiveness and safety~     of nicotinic acid in hemodialysis patients with hyperphosphatemia~   "
16897|NCT02836171|"~     he primary purpose of this study is to investigate potential pharmacokinetic interaction in~     healthy volunteers when apatinib is administered in combination with itraconazole. Secondary~     objective is evaluating the safety and tolerability of apatinib alone and when~     co-administered with itraconazole.~   "
16898|NCT02836158|"~     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high~     effective in elderly patients with primary central nervous system lymphoma (PCNSL).~   "
16899|NCT02836145|"~     Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged~     women that frequently cause urogenital infection, voiding difficulty, urinary retention,~     pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of~     women. Risk factors of the above diseases include pregnancy, vaginal delivery, and~     menopausal status. Despite playing a crucial role in the pathophysiology of the above~     diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the~     current treatment modalities.~      The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for~     current research and future cell therapy because of their significant self-renewal,~     differentiation potential and the relative lack of ethical conflict. With the advent of~     efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into~     hiPSCs, researchers can generate personalized lines of cells from which it will be possible~     to obtain differentiated cells in a less invasive way, introducing opportunities in treating~     diseases that are now considered incurable.~      Until very recently, little success has been achieved in terms of skeletal muscle~     differentiation from hiPSCs. The purpose of this study is to explore the applicability of~     the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the~     associated biomolecular messages. It is anticipated that the derived skeletal muscle~     progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence~     and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital~     problems.~   "
16900|NCT02836132|"~     The aim of this Phase II Small Business Technology Transfer grant is to complete development~     of a virtual reality intervention to augment and improve commercial Internet-delivered~     behavioral weight loss treatments, and to test it in a randomized controlled trial.~   "
16901|NCT02836119|"~     The overarching study aim is to evaluate the development of sleep behavior and gut~     microbiota (GMB), and their potential interaction, during the vulnerable period of the first~     year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new~     insight into the functional coevolution of the GMB and host sleep behavior.~   "
16902|NCT02836106|"~     The aim of this project is to elucidate how high-fat meals with different kinds of dairy~     products affect postprandial responses of lipid metabolism and inflammatory markers in~     healthy and obese subjects.~   "
16903|NCT02836093|"~     Many patients receiving radiation therapy for breast cancer experience fatigue although~     doctors do not fully understand why. The purpose of this study is to test if patients who~     experience fatigue during radiation treatment for breast cancer have changes in their~     capability to perform exercise on a treadmill.~   "
16904|NCT02836080|"~     Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%,~     yet youth are challenged to access services in a timely fashion. To address MHA system gaps,~     this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for~     at-risk youth with MHA challenges. In partnership with community agencies, adolescent~     psychiatry hospital departments, and family health teams, investigators have developed an~     innovative model of service provision involving rapid access to MHA services. This model~     will be implemented and compared to the usual treatment youth receive in hospital-based,~     outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services~     geared to need in a youth-friendly environment is expected to result in better MHA outcomes~     for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more~     youth- and family-centred, and be more cost-effective.~   "
16905|NCT02836067|"~     The purpose of this study is to learn how smoking affects the immune systems in people with~     HIV infection. The investigators would like to know if HIV infected smokers who quit smoking~     have different responses in their tissues from people who keep smoking.~   "
16906|NCT02836054|"~     Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40~     and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar~     disorder, after an evaluation of their cognitive functions.~      Comparison between two groups of patients : patients with cognitive disorders and patients~     without cognitive disorders.~      The objective is to describe and compare the profile of those biomarkers in those two~     populations.~   "
16907|NCT02836041|"~     The investigators want to better understand how children sleep at night at MSKCC, so that~     the investigators can learn how to improve the sleeping environment.~   "
16908|NCT02836028|"~     The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of~     talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and~     safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed~     ovarian, fallopian tube, and peritoneal cancer.~   "
18029|NCT02821364|"~     PIPT Trial (Philadelphia Immediate Transport in Penetrating Trauma Trial) A prospective~     randomized clinical trial comparing pre-hospital procedures to immediate transportation in~     patients with penetrating injury and shock.~   "
16909|NCT02836015|"~     The investigators seek to apply a shared medical visit model and interdisciplinary approach~     to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c~     as a marker of glycemic control and evaluate their mood with PHQ screening tools. The~     investigators seek to improve diabetes care for this group of underserved patients.~     Potential participants will be selected from the UNMC diabetes registry. Eligibility~     criteria includes adult patients over the age of eighteen years old with Type 2 diabetes,~     HgbA1c greater than 8%, whose preferred language is Spanish. Exclusion criteria include~     pregnancy, residency at a nursing home or other facility, substance abuse, and physician~     recommendation that study is not appropriate for the patient.~   "
16910|NCT02836002|"~     This is a single-center, open label study. The primary aim of this project is to develop a~     controlled human malaria infection transmission model (CHMI-trans) or challenge model to~     evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to~     block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum~     (Pf) gametocyte carriers for Anopheles mosquitoes.~   "
16911|NCT02835989|"~     Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment~     program for high users of Emergency Medical Services (EMS). Individuals who have been~     identified as active callers to EMS, individuals who have called EMS for lift-assists, and~     direct paramedic referrals are referred into the community paramedicine home visit program.~     The program will focus on in-home chronic disease management, community health service~     connections, and EMS usage education. Aside from chronic disease management, aspects of the~     program include health-related quality of life, social isolation and other social~     determinants of health. Participants in the program will have up to 3 one-on-one home visits~     from a community paramedic to ultimately reduce repeat EMS calls and improve their overall~     health.~   "
16912|NCT02835976|"~     This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum~     of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the~     pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.~   "
16913|NCT02835963|"~     No studies have analyzed the predictive value of different anamnestic and clinical signs for~     the diagnosis of acute heart failure (AHF) in patients admitted to emergency department.~     That's why the expert group of the AHF of South West of France mobilizes to conduct this~     study to evaluate the diagnostic predictive value of different anamnestic and clinical signs~     for the diagnosis of AHF to emergencies.~   "
16914|NCT02835950|"~     The objective of this study is to assess the safety, performance and initial effectiveness~     of the TIVUS™ System when used for pulmonary artery denervation through subjective and~     objective change in clinical parameters and haemodynamic evaluation. This is a prospective,~     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up~     to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who~     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific~     medications.~   "
16915|NCT02835937|"~     Do ambulatory RBC transfusions improve home functional status?~   "
16916|NCT02835924|"~     The purpose of this study is to assess the safety and tolerability of different~     dose-escalation approaches of regorafenib in mCRC patients.~   "
16917|NCT02835911|"~     This registry study is intended to establish a large prospective longitudinal clinical~     cohort of lymphoma patients in Malawi, as such data is currently lacking from sub-Saharan~     Africa. The investigators will perform core biopsies on at least 800 consecutively enrolled~     patients with suspected lymphoma for accurate histopathologic characterization. The~     investigators will systematically collect relevant clinical and laboratory data, and~     longitudinally follow those with confirmed hematologic malignancies receiving treatment~     according to local standards of care to assess outcomes.~   "
16918|NCT02835898|"~     Objective: The aim of this pilot study is to evaluate the alterations of epigenetic patterns~     in periodontally diseased individuals, before and after periodontal treatment, also in~     comparison to periodontally healthy patients.~      Materials & methods: Twenty patients were voluntarily enrolled in two groups: 10~     participants with healthy periodontium, and 10 participants with chronic periodontitis.~     Clinical parameters were recorded and gingival biopsies were collected within the following~     timelines: At baseline (for both groups), after 15 days (for the diseased group only) and~     after two months (for the diseased group only).~   "
16919|NCT02835885|"~     The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus~     Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the~     physiological effects of tVNS at different stimulation parameters. The electrical~     stimulation variables will be pulse width, frequency, and current. This will be tested in a~     laboratory setting and will measure tVNS effects on heart rate, respiration rate, blood~     pressure, and perceived pain. This is a feasibility and small safety study.~      Hypothesis: tVNS is feasible and safe~   "
16920|NCT02835872|"~     There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in~     order to confirm the product's efficacy. Thus, the objective of this study is to assess the~     effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.~   "
16921|NCT02835859|"~     The purpose of this study is to collect data that will help researchers better understand~     the various causes of obesity and diabetes; particularly to understand how consumption of~     NCASs affects the way the body uses nutrients.~   "
16922|NCT02835846|"~     This purpose of this study is to understand the types of bacteria that are in the bladder~     and vagina in patients with overactive bladder (OAB) symptoms and understand if the types of~     bacteria change when with the use of estrogen in the vagina. The investigators are also~     trying to understand how estrogen influences the body's ability to make substances called~     peptides that can kill bacteria.~   "
16968|NCT02835248|"~     Medical alert devices with automatic fall detection functionality use accelerometry to~     detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing~     the alert button. This can save lives and prevent complications associated with long periods~     of time spent on the floor after a fall. In this project, the sensitivity and false alarm~     rate of a commercially available medical alert device will be tested in a population of 200~     community-dwelling older adults.~   "
16923|NCT02835833|"~     Angiogenesis, the development of new blood vessels, plays an important role in the disease~     development and tumor growth in many solid organ malignancies. Bevacizumab was the first~     anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with~     multiple tumor types. However, the responses from Bevacizumab are often transient due to the~     tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways~     instead.~      Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer,~     colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and~     Nintedanib are being proposed to target the tumor's manipulation processes to generate~     alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.~   "
16924|NCT02835820|"~     Randomized control pilot 12 week feeding trial to compare the preliminary effects of~     ketogenic diet (versus patient choice diet) on HIV-associated neurocognitive impairment. N =~     20 (n = 10/10) randomized to diet condition. Pilot data necessary to evaluate the~     feasibility and determine initial data for primary outcomes in order to accurately determine~     needed sample size for larger clinical trial.~      Outcomes: 1) cognition (NIH Toolkit), 2) cardiometabolic markers (insulin glucose, insulin~     resistance, markers of inflammation), and 3) neural activity (as determined by functional~     MRI..~   "
16925|NCT02835807|"~     A sample of mothers in Tennessee are recruited to a group-randomized pretest-posttest~     controlled trial evaluating the effect of a social media campaign to decrease mothers'~     permissiveness for daughters to indoor tan. The primary outcomes is mothers' permissiveness~     for indoor tanning by daughters. Secondary outcomes are mother's indoor tanning prevalence~     and their support for stricter bans on indoor tanning by minors.~   "
16926|NCT02835794|"~     The purpose of this study is to determine the safety and establish the maximum tolerated~     dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with~     relapsed and/or refractory MDS.~   "
16927|NCT02835781|"~     Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls~     reconstructions. However, it is solely used in breast reconstructions after breast carcinoma~     amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared~     to current treatment options, however, this has to be proved.~   "
16928|NCT02835768|"~     Background: Provision of anticipatory guidance to parents is recommended as an effective~     strategy to prevent injuries among young children. Internet-based anticipatory guidance is~     suggested to reinforce the effectiveness of injury prevention, and improve parents'~     knowledge on child safety. Parents receiving the guidance can reduce children's exposure to~     injury risk by adopting better childcare practices and using appropriate child safety~     devices at home.~      Objective: This study will examine the effectiveness of Internet-based injury prevention~     program with parental anticipatory guidance in enhancing mothers' knowledge on child safety.~     It aims at increasing mothers' knowledge and motivation of learning about domestic injury~     prevention through a new Internet-based intervention model. It also targets to improve~     mothers' attitude and perceived behavioral control of domestic safety practice.~      Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers~     from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong.~     Participating mothers will be randomized into the intervention or control group with equal~     likelihood. Mothers in intervention group will be provided with free access to an~     Internet-based injury prevention program with anticipatory guideline whereas those in the~     control group will receive relevant parenting booklet.~      Results: It is hypothesized that mothers' general and age-appropriate knowledge on child~     safety and motivation of learning about domestic injury prevention as the primary outcome~     measures will be enhanced.~      Conclusions: The Internet is increasingly recognized as a practical and cost-effective~     platform for health education and safety information delivery. The goals of this study are~     to examine the effectiveness of a new Internet-based intervention program for improving~     mothers' knowledge, and raising mothers' awareness about the importance and consequences~     caused by domestic injuries.~   "
16929|NCT02835755|"~     This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV)~     vaccine intervention works in increasing HPV vaccine coverage among young adult gay and~     bisexual men. Giving young men information about the HPV vaccine and the importance of~     vaccination may encourage them to get the HPV vaccine.~   "
16930|NCT02835742|"~     Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.~      Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy~     study.~   "
16931|NCT02835729|"~     The purpose of this study is to characterize the regimen limiting toxicities (RLT) and~     recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving~     remission induction chemotherapy with cytarabine and idarubicin.~      Safety and tolerability of Indoximod will also be evaluated at the RP2D in combination with~     standard-of-care (SOC) chemotherapy (defined as induction therapy with idarubicin and~     cytarabine and consolidation with high-dose cytarabine (HiDAC) in this trial) followed by~     single agent indoximod maintenance therapy in patients with newly diagnosed AML as compared~     to safety and tolerability of SOC chemotherapy alone.~   "
16932|NCT02835716|"~     This Observational protocol will attempt to verify two recent and very critical concepts in~     ALZ Clinical Research by studying high-risk individuals who already are taking medications~     which may prevent the onset of ALZ.~        -  It may be possible to determine the future development of ALZ in a preclinical state in~          a cognitively normal but high risk individual at least 18-24 months before any symptoms~          develop of cognitive impairment.~        -  Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ~          can prevent of delay the occurrence and severity of ALZ.~      Caveats~      Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat~     ALZ, nor develop or use medications or diagnostic neuroimaging outside of already approved~     and accepted parameters. Persons who volunteer to be study subjects in this observational~     protocol will be under the care of their primary care / specialty physician, who will order~     tests and treatments as they see appropriate.~      Although there is a very large body of peer-reviewed scientific literature demonstrating~     that certain functional MRI patterns are associated with certain neurologic conditions, the~     utilization of fMRI for the evaluation of neurologic disorders is still considered an~     emerging science and therefore in the investigational stage. Although this protocol will~     report on brain patterns of certain neurologic conditions such as cognitive impairment and~     Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings~     are not considered stand alone or diagnostic per se and should always be considered by the~     PMD in conjunction with the patient's clinical condition. These data should only be used as~     additional information to add to the PMD's diagnostic impression.~   "
16933|NCT02835703|"~     The purpose of this study is to evaluate safety and efficacy of three main perfusion methods~     in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.~   "
16969|NCT02835235|"~     This trial is conducted in the United States of America. The aim of the trial is to~     investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and~     Female Subjects being overweight or with obesity~   "
16935|NCT02835677|"~     With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of~     caregiver assistance, with a concomitant increase in burden for the caregiver. In fact,~     effect on caregiver burden can be seen as a potential indicator of the efficacy of MS~     management, suggesting that the caregiver is an appropriate and independent target for MS~     therapeutic strategies.~      MS patients report difficulty implementing and continuing with home exercise, mobility, and~     walking programs. This feasibility study will test integration of a successful behavioral~     caregiving intervention into clinical practice to improve functioning of Veterans with~     multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a~     behavioral caregiver intervention designed to address caregiver coping and management of~     patient concerns, with special focus on patient mobility and walking. A pre-post~     intervention design will compare outcomes for Veterans and Caregivers.~      For Veterans, the intervention will target Caregiver participation in home-based Veteran~     mobility activities. MS Caregivers report high burden, stress, and depression involved in~     caring for their loved ones, especially as mobility declines and these outcomes are related~     to physical and emotional health status of the patient. For Caregivers, the intervention~     will focus on improving Caregiver coping and on managing MS-related problems. Outcomes for~     both will be measured at baseline, 3 months, and 6 months.~      Study Objectives include:~        1. Test whether a caregiver intervention can be integrated into an MS clinical setting.~        2. Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and~          number of Veteran MS problems and safety alerts reported).~        3. Determine whether Veteran outcomes are improved (EDSS walk, timed up and go test,~          self-efficacy, and depression).~        4. Determine which types of Caregivers will benefit most.~        5. Determine which types of Veterans will benefit most.~        6. Refine materials for future clinical research, translation and implementation.~   "
16936|NCT02835664|"~     This study will investigate the effects of 6 week Nicotinamide Riboside supplementation~     (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will~     be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information~     about the underlying mechanism, will be muscle mitochondrial function, brown fat activity,~     ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body~     composition and acetylcarnitine levels.~   "
16937|NCT02835651|"~     The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid~     (C18:0) have different effects on HDL metabolism during the fasted state.~   "
16938|NCT02835638|"~     The main goal of this French multicenter observational cohort study is to prospectively~     collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the~     quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of~     Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.~   "
16939|NCT02835625|"~     Compare digital breast tomosynthesis (DBT) with digital mammography (DM) as a screening tool~     for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening~     Program at the screening unit in Bergen, Norway, with regard to early performance measures,~     including prognostic and predictive tumor characteristics, radiation doses and~     cost-effectiveness.~   "
16940|NCT02835612|"~     There are several intervention programs involving multisensory and motor stimulations such~     as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a~     continuous program of early intervention involving very preterm infants' families in their~     first 12 months of life taking the chance of their neuronal plasticity during this period.~     Preterm infants born in our institution will be included when they complete 48 hours after~     birth (first intervention). All preterm infants and their mothers will be followed during~     neonatal period and pre hospital discharge they will have a second intervention ( to measure~     parental bond ). After discharge they will be conducted to follow up program and we will~     divided all very low birth weight infants included in the study in two groups according~     previous randomization:~        1. Standard care with motor, and cognition evaluation and intervention according to their~          needs~        2. Program of early intervention with parents' orientation independently of f the standard~          evaluation and care that will be performed.~      All phases of neurodevelopment will be evaluated, and the parents will be oriented to~     stimulate motor, language and cognition iteratively and continuously at home; this is a~     innovative method to improve very preterm neurodevelopment outcome.~      Randomization: in neonatal period, preterm infants will be sequentially randomized when they~     completed 48 hours after birth in:~      Group 1- conventional group (CG): standard care, according to the routine care of the NICU~     (skin-to skin care by mother, kangaroo care ).~      Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage~     therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from~     randomization until hospital discharge. Intervention performed exclusively by the mothers~     was based on studies regarding the application of skin stimulations and passive exercises in~     preterm infants.~      Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the~     routine care of the neonatal intensive care unit (NICU).~   "
16941|NCT02835599|"~     REVOLUTION will be a US multicenter observational registry in scope and governed by a~     steering committee of approximately 8 experts in NSCLC and outcomes research. The primary~     goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be~     a multicenter registry enrolling approximately 2,500 patients. Additional patients limited~     to those with EGFR mutations may be enrolled following the initial study period as needed to~     ensure adequate sample sizes needed to examine primary questions of interest in the EGFR~     mutant population. Patients will be enrolled over a three year period across approximately~     25 geographically diverse academic as well as community based sites within the US. The five~     year follow-up period will ensure robust survival data for correlations with clinical,~     tumor, and treatment variables.~      The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with~     particular characteristics of interest including patients with adenocarcinoma, and EGFR~     mutations and effectively evaluate these patients with respect to key outcomes of interest~     including overall survival, time to progression, stage at progression, secondary metastases~     including brain metastases (at diagnosis and progression), comorbidity burden, and~     performance status at index date.~      The study design allows a cross-sectional perspective with collection of detailed patient~     and clinical characteristics at enrollment followed by longitudinal assessment of clinician~     and patient-reported endpoints every three months. Centralized follow-up will be conducted~     by having sites upload patient data following each visit via the web-based data system, with~     patients who do not show up for site visits being contacted via telephone by the Duke~     Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will~     be weighted based upon provider specialty and ability to enroll patients with NSCLC with the~     specified inclusion criteria.~   "
16942|NCT02835586|"~     It is a pilot study to evaluate the feasibility and the efficiency of local delivery of~     paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the~     realization of a large randomized multicentric study. Patients concerned are in critical~     ischemia.~   "
16943|NCT02835573|"~     The purpose of this study is to evaluate the potential diagnostic and prognosis value of~     circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial~     injury at the emergency department (ED) and intensive care unit (ICU).~   "
16944|NCT02835560|"~     This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple~     regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin~     500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment~     of H.pylori.~      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal~     ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive~     patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based~     bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth~     Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID.~     After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from~     the first day dosing.~   "
17006|NCT02834741|"~     This is a first in human study of NYX-2925. It will evaluate single and multiple ascending~     doses of NYX-2925 in healthy volunteers.~   "
17007|NCT02834728|"~     This was a prospective multicenter cohort study of elderly people admitted to medical wards~     via emergency departments. Subjects were followed up to 36 months. It aimed to study the~     inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included :~     85+/-5 years, and mainly women (65%).~   "
16945|NCT02835547|"~     The hypothesis is that chronic inflammatory dysimmune state promotes the development of~     cardiovascular complications. The biological assumption is based on the fact that chronic~     inflammation promotes lesions of the vessel wall (endothelial alterations, calcification,~     atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in~     prevention.~      The project CARMIN involves the assessment of cardiovascular risk factors, their management,~     and their influence on cardiovascular prognosis in patients with autoimmune diseases and~     immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of~     patients with different types of dysimmune disorders: systemic lupus erythematosus,~     rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants,~     and hematopoietic stem cells transplants.~   "
16946|NCT02835534|"~     This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to~     rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients.~     It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.~   "
16947|NCT02835521|"~     Introduction; reception must be understood as the offered attention within the relationship~     between a healthcare worker and the patient, including attitudes of inclusion, hearing,~     valorization of complains and identification of needs, being these individual collective. As~     a part of this process, communication is a primary and indispensable toll through which the~     healthcare team and the patient interchange information.~      Objective: to evaluate the influence of perception of patients suffering of knee~     osteoarthritis over fear, catastrophizing of pain and effectiveness, related to~     intra-articular injection od corticosteroids.~      Material and method: it will be performed a prospective, controlled and randomized study~     eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint~     injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the~     outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will~     be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.~   "
16948|NCT02835508|"~     The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of~     JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60~     milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male~     Japanese participants.~   "
16949|NCT02835495|"~     Diabetes and obesity are both major public health concerns and the prevalence of diabetes is~     even higher in the patient population of the Veterans Administration. This planning project~     is designed to adapt a successful weight-loss program for delivery through an existing~     outpatient clinic to reach local Veterans at risk for developing diabetes. The information~     gathered as a part of this project will be used to plan a larger trial designed to improve~     the health of Veterans by offering them a diabetes prevention program through their usual~     source of healthcare.~   "
16950|NCT02835482|"~     The use of the femtosecond laser causes an increase in the intraocular pressure (IOP)~     between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).~      If it is known that elevated IOP accelerates the degradation of retinal ganglion cells,~     whose axons form the optic nerve.~      No data has been published to date on potential adverse effects of femtolaser cataract~     surgery performed in patients with glaucomatous optic neuropathy.~      Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed~     analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic~     neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss~     of this layer.~      The investigators propose to evaluate the effects of elevated intraocular pressure in~     glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.~   "
16951|NCT02835469|"~     The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after~     embryo transfer in patients treated with Menopur® Multidose~   "
16952|NCT02835456|"~     The aim of this study is to determine if the Sharklet catheter, with its unique surface~     micropattern, reduces infections in participants, when compared to a standard silicone~     catheter.~   "
16953|NCT02835443|"~     This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment~     of stroke and will help understand if DBS improves motor recovery for patients who continue~     to have significant impairment.~   "
16954|NCT02835430|"~     -  Gingival recession is defined as the apical migration of gingival margin beyond~          cemento-enamel junction with the exposure of root surface. More than 20% of the~          population presents one or more tooth surfaces with gingival recession.~        -  The main conditions leading to the development of this defect are gingival anatomical~          factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.~        -  The main goal of treating gingival recession is to restore the gingival margin to~          cement-enamel junction (CEJ) and normal sulcus with a functional attachment.~        -  A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second~          generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that~          contains growth factors and cicatricial properties for root coverage procedures.~        -  Space is necessary to provide a channel for the migration of progenitor cells towards~          and on the denuded root surface, where they can differentiate into cementum and~          periodontal ligament cells.~        -  Since the gingival recession defects are non-space making, it may be difficult using~          the membrane technique alone, and hence, the use of a graft material underneath the~          membrane may help to resolve this problem. Root coverage tended to be better with the~          addition of demineralized freeze-dried bone allograft (DFDBA). These allografts prevent~          the collapse of membrane into the defect, stimulate the proliferation of osteogenic~          progenitor cells, and are thus, capable of promoting regeneration of attachment~          apparatus.~        -  Till date, no study is available in the literature on clinical evaluation of CAF~          (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession~          defects.~        -  And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky~          Mountain Particulate Allograft) for the management of isolated gingival recession~          defects.~   "
16964|NCT02835300|"~     This project will preliminarily validate CampAir, an empirically-based dynamic e-health~     intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled~     asthma to learn how to manage their illness and improve their asthma control. In addition to~     developing a highly novel product for adolescents with asthma, the research proposed for~     this project will address unique scientific questions. Despite the high asthma prevalence~     among adolescents, few interventions have specifically targeted adolescents. This study is~     innovative in that it is among the few to focus on adolescents, who are often overlooked by~     the healthcare system. This research will assess factors associated with successful~     implementation of CampAir, thereby providing new information regarding how e-health~     interventions can be effectively developed and implemented for use with adolescents with~     asthma.~   "
17008|NCT02834715|"~     The main aim of the study is to assess the short term and 1-month metabolic effects of~     Stevia rebaudiana bertoni in patients with type 2 diabetes.~   "
16955|NCT02835417|"~     Background~      The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal~     acidosis. FHR variability is traditionally investigated using Fourier transform, however,~     fetal conditions differ from adults (higher frequency, widely instable signal) modifying~     spectrum repartition along frequencies, making this approach inappropriate. New mathematic~     approach, including Multifractal analysis, adaptative multiscale complexity analysis,~     nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify~     parameters associated with fetal acidosis. Modern classification system, driven by the data,~     based on these relevant parameters should help to dsiccriminate the fetus at risk for~     acidosis and help the clinician in decision making for the management and termination of~     labor. Analysing 20 to 30 minutes sliding windows with these different methods in a limited~     number of cases (foetus born with acidosis) and controls (foetus without acidosis) should~     lead to identify relevant parameters, which will be submitted to these classification tools.~     For external validation, a large database, including more than 4500 FHR recording documented~     with foetal outcomes, will be used to evaluate the performance of the combination of~     parameters identify and classification system used to discriminate foetuses at risk for~     short term acidosis or not, in order to give a relevant information to the clinician before~     acidosis occurs, to make the appropriate decision.~   "
16956|NCT02835404|"~     The objective of this study was to evaluate the efficacy and complication of the treatment~     of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without~     platinum in local advanced cervical cancer patients in the short and long term.~   "
16957|NCT02835391|"~     This study is a post market, multi-centre, randomised study evaluating PerClot compared to~     usual care. PerClot is a CE marked device and is currently used as a haemostat in~     gynaecological surgery throughout Europe. The purpose of this study is to collect additional~     post market data on its use in this indication.~   "
16958|NCT02835378|"~     In France, there is currently no data to directly estimate the number of bilateral upper~     limb amputations, their characteristics and therapeutic care.~      By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR)~     Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the~     upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of~     the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic~     of amputees patients referred by orthopaedic centres in the United Kingdom , whose~     population's characteristics are similar to France) identified 395 incident cases of upper~     limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic,~     infectious or related to diabetes. The population was relatively young, aged between 15 and~     54 year old.~      On this basis, the estimated number of new cases of bilateral upper limb amputations~     throughout France should therefore be about 40 incident cases over a 5-year period.~      This observational study is aimed at collecting comprehensive and high quality data to~     describe the French population of bilateral upper limb amputees.~   "
16959|NCT02835365|"~     Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in~     neurology to treat spastic contracture. Several clinical studies have suggested its efficacy~     in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose.~     French drug authority has authorized its use in 2012 whereas the l'European Association for~     the Study of the Liver recommends to perform additional studies on this indication.~      The goal of this observational study is to evaluate the use of baclofen for~     alcohol-dependence in real life care as well its efficacy.~   "
16960|NCT02835352|"~     This study evaluates the impact of essential oils massage on anxiety of patients who are~     suffering from cancer at a metastasis stage. Half of patients will be massaged first by~     essential oils and then by oil only. The other half will be massaged first by oil and then~     by essential oils.~   "
16961|NCT02835339|"~     The purpose of this study is to learn how medications participant will receive in the course~     of their delivery are metabolized (broken down by the body). The investigators hope to learn~     more about the way drugs are metabolized by pregnant women, and how those drugs are~     distributed in the blood and body compartments and cleared in the urine, and how maternal~     body weight affects the metabolism. With this information the investigators will be able to~     develop a treatment regimen considering factors in the body that affect magnesium levels so~     that the investigators can improve treatment of pregnant women. The goal of the study is to~     understand how different dosing of magnesium sulfate affects blood levels of the magnesium~     in larger women.~      Magnesium sulfate is generally given to patients to protect the mother against seizures in~     the case of preeclampsia. Different hospitals in the United States use different doses of~     magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate~     for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every~     hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at~     the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every~     hour until treatment for preeclampsia is complete. Participants will receive magnesium~     sulfate in the course of their normal clinical care whether or not they participate in this~     study.~   "
16962|NCT02835326|"~     The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA)~     compares a novel community-based exercise and dietary weight loss program to the Arthritis~     Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA)~     patients.~   "
16963|NCT02835313|"~     Stroke survivors, as a group, are extremely inactive and this has serious consequences for~     them, including an increased risk of a second stroke and developing other diseases. This~     study investigates a novel intervention designed to improve everyday activity after stroke~     by combining walking training to improve walking capacity with a program to encourage more~     daily walking.~   "
16965|NCT02835287|"~     The overall objective of the proposed cluster randomized trial is to test whether~     implementation of protocol-based integrated care will improve CVD risk factors (glycated~     hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 18 months and~     reduce major CVD events (non-fatal stroke, non-fatal myocardial infarction, hospitalized~     heart failure, and CVD mortality) over 3 years among patients with type 2 diabetes and~     additional CVD risk factors or clinical CVD compared to usual care in community clinics in~     Xiamen, China.~   "
17009|NCT02834702|"~     The study aims to examine the efficacy and safety of sinew acupuncture for chronic~     mechanical neck pain (CMNP).~   "
16970|NCT02835222|"~     This pilot phase II trial studies how well selinexor works when given together with~     induction, consolidation, and maintenance therapy in treating older patients with acute~     myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and~     daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Selinexor with induction, consolidation, and maintenance therapy may kill more~     cancer cells in older patients with acute myeloid leukemia.~   "
16971|NCT02835209|"~     Mechanical ventilation is a life-sustaining intervention in premature infants with~     respiratory difficulties. There is relative consensus when to intubate and provide positive~     pressure mechanical ventilation in the presence of respiratory failure. In contrast,~     discontinuation of mechanical ventilation during recovery remains largely subjective. A~     potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT).~     The efficacy of SBT or other tests used in older patient populations in improving clinical~     judgment is questionable in the neonatal population with its unique physiology, respiratory~     mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a~     standard part of neonatal assessment for extubation from mechanical ventilation.~      Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine,~     lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT.~     An SBT performed in one position may not predict infant respiratory status after extubation~     in another position. Understanding the impact of infant positioning and work of breathing~     indices independently or in combination with an SBT will aid clinicians in decision-making~     and potentially decrease neonatal morbidity (inaccuracy with timing and safety of~     extubation). This pilot study will begin to explore these clinically relevant factors.~      Objectives: This pilot study will investigate the (1) role of infant position on SBT score~     and (2) the relationship of work of breathing indices in reference to the SBT score and~     infant position.~   "
16972|NCT02835183|"~     The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1~     diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will~     be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be~     randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and~     then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa.~     The primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump~     calculators will be: mean postprandial glucose level and number of events with excessive~     blood glucose highs and lows.~   "
16973|NCT02835170|"~     This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy,~     safety of intramuscular injections of autologous immunoglobulin in patients with~     moderate-to-severe atopic dermatitis.~   "
16974|NCT02835157|"~     Fluid resuscitation is the cornerstone of pediatric shock management; current practices of~     fluid resuscitation in children are not evidence based. Normal saline is the preferred~     crystalloid recommended during initial resuscitation in shock, as the incidence of~     hyponatremia is lower with normal saline compared to all other fluids available and commonly~     used. However, normal saline has its own set of undesired physicochemical actions. Emerging~     data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and~     consequently, acute kidney injury associated with infusion of large volumes of normal~     saline. Balanced salt solutions or crystalloids, which have composition resembling plasma~     but lower chloride concentrations than normal saline, clearly decrease the risk of~     hyperchloremia and metabolic acidosis in adult as well as pediatric studies when used during~     the peri-operative period. The results favored balanced solutions in comparison to normal~     saline. Recent systematic reviews comparing balanced or buffered versus non-buffered fluids~     for surgery in adults favored the former solution as the metabolic derangements were less~     with the use of this type of fluid. In adult patients, the two solutions have been compared~     in various other settings as well such as in traumatic brain injury and in shock. The~     results favored balanced solutions in comparison to normal saline. However, in the~     non-surgical setting there is a paucity of evidence on the use of these solutions in~     children with shock and more evidence needs to be generated to support or refute the use of~     this fluid as compared to normal saline.~      Given this background, the investigators decided to compare the effect of two solutions on~     the incidence of acute kidney injury in children resuscitated with either of the two fluids.~     Children receiving volumes of at least 20 ml/kg in the first hour of resuscitation as~     boluses would be enrolled and followed up for the proposed outcome variables. The~     investigators plan to enroll 708 patients over a period of 3 years. The investigators~     believe that the proposed study will provide the answer to the safety of normal saline which~     is the most widely preferred initial fluid for fluid resuscitation in children with shock~     due to sepsis.~   "
16975|NCT02835144|"~     The prevalence of addictive disorders in old age is increasing. Age specific and appropriate~     therapeutic concepts tailored to in-patients thus represent a promising approach for the~     future. The investigated therapeutic intervention is a therapy program for integrated~     qualified acute treatment of alcohol and drug problems (TIQAAM).~   "
16976|NCT02835131|"~     Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia.~     Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals~     may respond to a new somatostatin analog, pasireotide. This is a compassionate use study of~     the effects of pasireotide on individuals with suboptimally treated congenital~     hyperinsulinism.~   "
16977|NCT02835118|"~     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses~     of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and~     females.~   "
16978|NCT02835105|"~     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single~     oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males~     and females.~   "
16979|NCT02835092|"~     The study evaluates the effects of two commercially available weight loss programs, the TSFL~     and the MEDD programs, each compared to a self-directed control diet, on changes in body~     weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and~     women.~   "
17010|NCT02834689|"~     Walking is encouraged for people with type 2 diabetes but there is little evidence that~     performing a bout of walking can improve glucose control. Furthermore, it is unknown how~     participant characteristics (e.g., age, sex, medications) impact the acute glucose responses~     to walking in people with type 2 diabetes. The primary purpose of this study is to examine~     how a standardized bout of walking impacts glucose control assessed over 24 hours using~     continuous glucose monitoring. A secondary purpose is to determine whether responses are~     influenced by age, sex, and medication use.~   "
17011|NCT02834676|"~     The aim of the study is to evaluate the clinical effects of Discogel® Radiopaque Gelified~     Ethanol as therapeutic substance for nucleolysis application in the patients with cervical~     disc hernia who had chronic pain and weakness on the neck, shoulders and arms.~   "
16980|NCT02835079|"~     Duchenne muscular dystrophy (DMD) is a progressive devastating disease that affects mainly~     boys, with an incidence of about 1:3,500 live births. The pathology of DMD is a result of~     non-repaired muscle damage that leads to muscle-tissue replacement by scar tissue, a process~     known as fibrosis. Currently, there is no effective treatment for the disease. The only~     therapy offered to these boys are steroids which slightly delayed the disease progression.~     The boys lose their ability to walk at around the age of 12, and die in the 4th decade of~     life from severe heart and lung problems.~      In this study investigators will test the efficacy of Tamoxifen treatment in ambulatory DMD~     boys. Tamoxifen is a drug used for palliative treatment of breast cancer patients and has an~     outstanding safety profile. In addition, Tamoxifen was tested in the past in boys, for other~     pediatric indications, and showed an excellent safety with no side effects.~      Tamoxifen is being tested in this study, as a therapy for DMD, for the following reasons:~      (i) it was shown to have anti-fibrotic effect in multiple in-vivo systems; (ii) it assists~     in the repair of damaged muscles.~      In other words, Tamoxifen is expected to have a synergistic effect on DMD patients, due to~     its dual mechanism of action. Indeed, Tamoxifen was shown to have significant beneficial~     effects in the mdx mouse model of DMD. Also, a small compassionate cohort of 3 boys, treated~     for 6 months with Tamoxifen, yielded very encouraging results.~   "
16981|NCT02835066|"~     This pilot trial studies patient function/fitness and psychosocial health in improving~     health-related quality of life and decreasing treatment-related toxicity in patients with~     stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may~     help doctors improve conventional therapy in patients with non-small cell lung cancer.~   "
16982|NCT02835053|"~     The investigators will examine the association between preoperative frailty and~     postoperative outcomes and resource utilization after emergency general surgery.~   "
16983|NCT02835040|"~     Pneumonia is the commonest illness requiring hospitalization in Australia. Elderly patients~     account for most admissions and incur highest costs due to longer hospitalizations, higher~     readmission risks and poor functional outcomes. Previous clinical trials show a number of~     medical and allied health interventions can effectively shorten hospitalization or reduce~     readmissions, but these have been poorly and inconsistently applied in practice. This~     proposed research builds on previous studies by applying these interventions as a~     standardized combined package, evaluating their effectiveness in a real world Australian~     setting and quantifying effects on both clinical outcomes and health service costs.~   "
16984|NCT02835027|"~     Study of acute lower ischemia therapies based on data collected from the Swedish Vascular~     Surgery Registry between 1994 and 2014.~      Primary endpoint is long term amputation-free survival and secondary end-points are 30 days~     and 1 year amputation-free survival as well as different revascularization techniques~     results and time trends.~   "
16985|NCT02835014|"~     This study will focus on screening for mental health symptoms in adolescents with type 1~     diabetes mellitus (T1DM) while assessing the relationship of these symptoms with a~     parent-reported parenting styles survey, and the youth's report of their ability to manage~     their own diabetes care through a self-efficacy survey. Gender differences will be explored~     in relation to the different measures.~   "
16986|NCT02835001|"~     Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on~     Hyperinflation in Severe Emphysema~   "
16987|NCT02834988|"~     The investigators hypothesize that performing SLND (instead of complete lymphadenectomy)~     will decrease complications such as hemorrhage, lower extremity lymphedema and lymphocyst~     formation while enhancing quality of life in EC patients with low risk for nodal~     involvement.~      The investigators also hypothesize that SLND is an effective method of staging these~     patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with~     newly diagnosed EC and this prognostic information obtained from SLND could guide selection~     of adjuvant treatment and improve overall survival.~      Using SLND as an alternative may also have additional medical and economic impacts.~     Prolonged hospitalization and associated costs can be avoided by shortening overall surgery~     duration.~   "
16988|NCT02834975|"~     The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the~     immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and~     Pembrolizumab will invigorate tumor-specific T-cell immunity in this setting by inhibiting~     PD-L1/PD-1 signaling, and may result in deeper and more durable responses compared with~     standard chemotherapy alone.~   "
16989|NCT02834962|"~     To study the difference between single and double bundle ACL graft cross-sectional~     dimensions compared with native ACL using postoperative 3-D MRI.~   "
16990|NCT02834949|"~     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session~     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and~     alcohol-related consequences in college students.~   "
16991|NCT02834936|"~     This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of~     advanced pre-treated Non-small cell lung cancer With HER2 Mutation.~      To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To~     observe Progression free survival (PFS). To assess the overall survival (OS).~      A secondary aim is to obtain safety information.~      To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.~   "
17012|NCT02834663|"~     Title of study:~      Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR)~     with DME assessed by microaneurysm changes: A pilot study Objectives To evaluate the effects~     of intravitreal Ranibizumab injection on microvascular changes in eyes of mild-to-moderate~     NPDR with DME~      Primary objective:~      To compare microvascular changes assessed by microaneurysm counts in eyes of~     mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline~     through 6 months after treatment.~      Secondary objectives:~      To investigate other efficacy endpoints including other microvascular, anatomical, visual~     acuity change and safety in mild-to-moderate NPDR with DME after intravitreal Ranibizumab~     injection from baseline through 6 months after treatment.~   "
17122|NCT02833220|"~     The purpose of this study is to determine the effects of TMS on the ANS. The investigator~     will determine whether single-pulse TMS of the primary motor cortex in the dominant~     hemisphere in healthy, young adults will affect 1) heart rate and heart rate variability, 2)~     blood pressure and 3) baroreflex function. This study is foundational in that it will begin~     to characterize how single-pulse TMS affects the ANS in healthy adults.~   "
16992|NCT02834923|"~     The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary~     clinical intervention frameworks that are commonly invoked to support better type 2 diabetes~     (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both~     the PCMH and CCM, and focuses on the central role of patients in managing their illness by~     engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite~     its recognized importance, SMS programs for diabetes continue to demonstrate limited~     effectiveness in the real-world of primary care.~      SMS is comprised of two complementary and interactive components: (1) patient engagement~     (e.g., the process of eliciting and responding to patients emotions and motivations related~     to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals,~     creating action plans). While several sophisticated SMS programs have been developed for~     T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely~     ignoring unique aspects of the patient context that drive and maintain health behavior.~     Considerable clinical research suggests that the addition of a structured, evidenced-based~     program of patient engagement can maximize the effectiveness of SMS programs for patients~     with T2DM in primary care.~      To date there has been no systematic study of the degree to which fully integrating enhanced~     patient engagement as part of SMS will increase the initiation and maintenance of behavior~     change over time, and for which kinds of patients enhanced patient engagement is essential.~     To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS~     behavior change tool program, called Connection to Health (CTH), with an enhanced CTH~     program that includes a practical, time-efficient patient engagement protocol, to create a~     program with an integrated and comprehensive approach to SMS, called Enhanced Engagement~     CTH (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with~     regard to self-management behaviors and glycemic control in resource-limited community~     health centers, where vast numbers of patients with T2DM from ethnically diverse and~     medically vulnerable populations receive their care. The investigators will use an~     effectiveness-implementation hybrid design, employing the Reach Effectiveness Adoption~     Implementation Maintenance (RE-AIM) framework to test these two SMS programs for T2DM. This~     will provide critical information that will support dissemination and implementation of~     effective SMS programs in resource-limited primary care settings, serving diverse and~     medically vulnerable populations with much to gain from improved SMS.~   "
16993|NCT02834910|"~     Enterobacteriaceae are bacteria of the gastrointestinal tract which are also the most~     frequently involved in bacterial infections, especially urinary tract infections. Because of~     their presence in the gut, these bacteria are the most exposed to antibiotic treatment~     administered to patients.~      Therefore, many antibiotic resistance mechanisms are observed in some of them. Quinolone~     antibiotics are often used because of their distribution in the body, of the great number of~     bacterial species that are sensitive to these antibiotics and the possibility to give oral~     treatments.~      For a long time no transferable resistance gene to quinolones from one bacterium to another~     had been observed. This phenomenon has been demonstrated in 1998 in a bacterium of the~     Klebsiella pneumoniae species carrying a qnrA gene which encodes a protein that protects the~     target of the antibiotic in the bacteria. Since several genes have been observed. These~     genes reduce the sensitivity of the bacteria without ever reach detectable resistance levels~     on the tests commonly used in the laboratory. However, these genes are often found among~     enterobacteria in combination with other mechanisms of resistance to other classes of~     antibiotics including beta-lactam antibiotics that are widely used antibiotics.~      Moreover, it is considered that quinolone administration to bacteria carrying these qnr~     genes could promote the emergence of mutants resistant to quinolones to a more high-level.~     That furthers multiresistance emergence when the bacteria is already resistant to~     beta-lactam antibiotics.~      The aim of this study performed between April 2008 and March 2009 was to collect strains~     resistant to beta-lactams because of the production of enzymes, called extended-spectrum~     beta-lactamase to determine quinolone resistance gene frequency in these bacteria.~      Meanwhile, control patients were selected to seek the emergence of these genes risk factors.~      The clinical study failed to identify specific risk factors, however, the biological study~     enhanced the knowledge on this issue with the setting-up of a method for rapid detection of~     these plasmidic mediated quinolones resistance genes and the description a new plasmid~     containing a qnr gene, qnrD, whose study is still ongoing.~   "
16994|NCT02834897|"~     The purpose of this study and demonstrate the reliability of EOS imaging system in the~     measurement of internal diameters of obstetrical pelvis versus Goldstandard current that~     is the pelviscanner.~   "
16995|NCT02834884|"~     SPECTArare is a program aiming at establishing a quality assured platform for collecting~     clinicopathologically annotated biological material from patients with primary rare tumors~     (6 new cases/100,000/year) to support biospecimen-based translational research and biomarker~     discovery.~   "
16996|NCT02834871|"~     The purpose of this study is to compare the cervical muscular force control , taking into~     account the proprioceptive signals, in patients with and without cervical dystonia.~   "
16997|NCT02834858|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic~     foot.This study intends to establish an optimal clinical research program, and attempts to~     break the technical bottleneck in the stem cell therapy for treating diabetes related~     vascular complications.~   "
16998|NCT02834845|"~     Controlled hypotension is a preferred method for reducing surgical bleeding during~     septoplasty operations however, the level of hypotension and bradycardia should not disrupt~     cerebral oxygenation. On this account, the investigators aim to investigate the effects of~     different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation~     during controlled hypotension using near infrared spectroscopy.~   "
16999|NCT02834832|"~     This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the~     wear of denture teeth.~   "
17000|NCT02834819|"~     The purpose of this study is to determine whether nebulized 3% hypertonic saline is more~     effective than the current standard of care in the treatment of viral bronchiolitis in~     children.~   "
17001|NCT02834806|"~     This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent~     - BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent~     System is a single use device/drug combination product comprising:~        -  A mounted Cobalt Chromium (CoCr) alloy based stent~        -  A Rapid Exchange (RX) delivery system~        -  A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving~          coronary luminal diameter in patients with symptomatic heart disease due to lesions in~          vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.~   "
17002|NCT02834793|"~     This study is being conducted to demonstrate that perampanel given as adjunctive~     anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in~     participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome~     (LGS).~   "
17003|NCT02834780|"~     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and~     recommended Phase 2 dose (RP2D) of H3B-6527 (Part 1), and to assess the safety and~     tolerability of H3B-6527 as a single agent administered orally (Part 2) in participants with~     advanced hepatocellular carcinoma (HCC).~   "
17004|NCT02834767|"~     Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence~     exists that some behavioral (e.g. exercise based) therapies may assist in lessening the~     severity of this disorder. The proposed investigation will examine the effects of eight~     weeks of genioglossus muscle strength training on measures of snoring and OSA severity as~     well as genioglossus protrusive muscle strength.~   "
17005|NCT02834754|"~     This is a pilot study that will determine the endoscopic recurrence of Crohn's disease 12~     months after curative, resective ileal or ileocolonic surgery in patients receiving~     post-operative vedolizumab (Entyvio) or placebo. The investigators hypothesize that the~     administration of post-operative vedolizumab will decrease the endoscopic recurrence of~     Crohn's disease.~   "
17013|NCT02834650|"~     This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular~     Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better~     understand the health of the heart and changes in heart health over time in boys with DMD.~      Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that~     can serve as endpoints for detecting on-target and/or off-target cardiac effects during~     clinical drug trials for boys with DMD.~      Consequently, the first objective is to identify and characterize several cardiac MRI~     biomarkers for boys with DMD.~   "
17014|NCT02834637|"~     Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and~     mortality rates are very high. HPV vaccines are most effective if given to girls who have~     not yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe,~     acceptable and can be delivered with high coverage (around 80%). However, the cost of~     delivering HPV vaccine is considerably higher than costs for traditional infant/child~     vaccinations. This is primarily because of costs to establish outreach programmes and~     associated personnel costs including nurses who must spend significant time away from their~     posts to deliver vaccine, especially if multiple doses are needed. There is global interest~     in simplifying HPV vaccine delivery by reducing the number of doses. If a single dose could~     be given, this could halve the costs of delivery, making it more accessible to the~     populations that need it most. Recently, the WHO recommended that 2 doses of HPV vaccine~     could be given to young girls, based on studies in high and upper middle income countries.~     However in Africa high rates of infections like malaria and worms can affect immune~     responses to vaccines. It is essential to know that reducing the number of doses does not~     reduce the protective immune response of these vaccines. The investigators are conducting a~     trial in Tanzanian girls aged 9-14 years to establish whether a single dose of HPV vaccine~     produces immune responses that are likely to be effective in preventing cervical cancer. Two~     different HPV vaccines, the bivalent (2-v) vaccine that protects against HPV 16/18 (the~     cause of 70% of cancers) and a new 9-valent (9-v) vaccine that protects against 9 HPV types,~     will be compared. The trial will randomise 900 girls to 6 groups and follow them for 36~     months. Girls will receive the 2-v or the 9-v HPV vaccine, as 1, 2 or 3 doses. Girls~     receiving 1 or 2 doses will be compared with those receiving 3 doses of the same vaccine, to~     ensure that the reduced dose regimen produces an immune response that is not inferior to the~     standard 3 doses. The immune responses in this study will also be compared with results from~     other countries where the vaccine has been shown to be protective. This will provide~     information about whether a reduced number of doses is likely to be protective in Africa.~     This work will be extremely important in informing future HPV vaccination strategies and~     will be one of the first randomised trials of 1 and 2 doses of any HPV vaccine in Africa.~   "
17015|NCT02834624|"~     Premature infants frequently have trouble breathing after birth. If the respiratory disorder~     is caused by surfactant deficiency or dysfunction, the disease is treated with a medication~     called surfactant that is given to the infant through a tube inserted into the windpipe.~     This study will compare the safety of two of the commonly used surfactants, poractant and~     calfactant,in the United States. Poractant has added chemicals called phospholipids which~     are known to cause inflammation and irritation in the body of premature infants. The~     investigators will compare this to another similar surfactant that does not contain these~     chemicals by looking at samples from the windpipe, while the tube is in place, and from~     blood tests in the first few days of life.~      The investigators are hoping to learn whether calfactant is a safer therapeutic agent to~     treat respiratory distress syndrome in preterm infants compared to poractant.~   "
17016|NCT02834611|"~     This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced~     solid tumors.~   "
17017|NCT02834598|"~     The study evaluates the benefits of a rocking movement on well-being and attention, through~     high-density electroencephalography recordings. The effect of the rocking movement is~     compared to a seated position and a lying position.~   "
17018|NCT02834585|"~     Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging~     5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local~     recurrence and distant metastasis. A link seems to exist between local recurrence and~     overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A~     combination of resection and radiotherapy is the optimal treatment of primary tumours~     according to histological grade and surgical result. Modern imaging techniques such as~     ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to~     rule-out a recurrence in patients operated on for STS. However, none of this technique is~     perfect and different advantages and drawbacks have to be considered in choosing one or~     another technique. In the past, US was used in tumour follow-up to detect tumour~     recurrences, however these studies didn't use high-resolution transducers and the timing of~     imaging respect to surgery was not defined. The recent advances in transducer technology~     improved the diagnostic capabilities of US.~      For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality.~     The reasons are that US is widely available, fast, easily repeatable and often more~     accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers~     have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in~     the evaluation of superficial soft-tissues. US and MR Imaging are often not able to~     differentiate benign from malignant tumours, therefore several lesions detected with US or~     MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of~     Medical Oncology) published in 2010 found that there are no published data to indicate the~     optimal routine follow-up policy of surgically treated patients with localized disease.~     Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is~     superior and cost-effective compared to US for the assessment of the primary site.~     Considering that surgically treated intermediate-/high-grade patient may be followed~     frequently, even every 3-4 months in the first 2-3 years and considering that performing US~     is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic~     performance of US in the detection of local recurrences of adults patients with soft tissue~     sarcomas of the limb.~   "
17019|NCT02834572|"~     Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at~     severely disproportionate rates. A key component of HIV prevention for communities at risk~     is diagnosing HIV infections through regular HIV testing. A significant proportion of young~     Black MSM and transwomen have not tested in the prior year. This research study seeks to~     address low HIV testing rates among young Black MSM and transwomen by testing a brief~     Internet-based HIV testing intervention optimized for mobile devices. The intervention takes~     advantage of the variety of HIV testing options now available, including the HIV self~     testing, couples-based HIV counseling and testing and traditional clinic-based testing and~     will provide men and transwomen with a tailored recommendation of their optimal HIV testing~     approach. The investigators are conducting a pilot randomized study among young Black MSM~     and transwomen followed for 6 months to estimate the intervention's potential efficacy in~     increasing HIV testing.~   "
17020|NCT02834559|"~     This study investigates the effectiveness of a simple treatment to prevent proliferative~     vitreoretinopathy (PVR).~      Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is~     used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal~     detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that~     receives the trial drug.~   "
17021|NCT02834546|"~     The aim of this pilot study is to correlate the sorafenib plasma concentration to observed~     toxicity and to the disease control rate in 100 patients undergoing a palliative treatment~     of hepatocellular carcinoma (HCC). If some correlations are observed, we will consider~     planning a larger interventional study to adjust sorafenib daily dose to plasma~     concentration.~   "
17033|NCT02834390|"~     This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile,~     the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical~     studies of the combination of quizartinib and induction and consolidation chemotherapy.~   "
17022|NCT02834533|"~     Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait~     training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).~      Method: A Randomized, double-blind, controlled clinical trial was carried out in forty~     patients with relapsing remitting MS. All patients were randomized into two groups. One~     group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both~     the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A~     skilled-blinded neurologist and psychologist administered clinical and neuropsychological~     scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of~     the rehabilitative program.~   "
17023|NCT02834520|"~     60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30~     control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa~     utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.~   "
17024|NCT02834507|"~     The purpose of this study is to determine the effect of two different multiple-dose regimens~     of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of~     levodopa in Parkinson's Disease (PD) patients.~   "
17025|NCT02834494|"~     Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for~     predicting histological response to neoadjuvant chemotherapy in patients with locally~     advanced breast cancer.~   "
17026|NCT02834481|"~     The main objective is to assess correlation between ANI/NIPE values and external evaluation~     COMFORT B scale during painful medical cares and during said comfort medical cares in~     intubated children admitted in pediatric intensive care unit postoperative of cardiac~     surgery with extracorporeal circulation.~   "
17027|NCT02834468|"~     The project was undertaken by Qilu Hospital, Shandong University in China. In order to~     report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and~     intravenous immunoglobulin in the management of newly diagnosed ITP patients.~   "
17028|NCT02834455|"~     Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary~     pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is~     difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant~     cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing~     mutation status for targeted therapies.~      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than~     conventional CT for detecting malignant lesions >10mm. However, no randomised trial has~     investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely~     PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.~      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing~     direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the~     medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but~     allows only sampling from the parietal pleura. To date, no randomised studies have compared~     medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or~     economics.~      The investigators will perform two randomized studies to investigate whether~        1. PET/CT is comparable to CT alone~        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,~          time-to-diagnosis.~   "
17029|NCT02834442|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     MT-7117 in healthy subjects.~   "
17030|NCT02834429|"~     The aim of this study is to assess the clinical utility of the whole blood~     transglutaminase-based rapid test against current serological tests and the gold standard of~     duodenal biopsy. The investigators will recruit patients (n=1000) from the endoscopy~     department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK). The patients~     recruited for this study will already have been referred for a consultation and gastroscopy.~     In addition, these patients will already have been serologically tested for IgA TTG, EMA and~     a total IgA immunoglobulin level (as per normal clinical practice).~      All duodenal biopsy specimens will be fixed in buffered formalin and embedded in paraffin~     wax. Standard, 3μm thick sections at three levels will be stained with haematoxylin and~     eosin and reported routinely. Additionally, biopsies demonstrating increased intraepithelial~     lymphocytes only (changes compatible with but not diagnostic of coeliac disease) will be~     stained with KiRAS or CD4/CD8 which are markers for coeliac disease.~   "
17031|NCT02834416|"~     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive~     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC~     but has many side effects. Researchers have shown that exercise, specifically one-on-one~     supervised exercise improves many of the side effects of ADT. However, exercise programs for~     men on ADT are not widely available. More questions need to be answered in order for~     exercise programs to become part of PC treatment. First, can programs that require fewer~     resources, such as group-exercise or home-based exercise, also improve ADT side-effects?~     Second, do exercise-related benefits continue beyond the structured exercise program? And~     what makes people continue exercising? Third, which exercise program is most cost-effective?~      In this study, the investigators will compare: (a) group supervised in-centre and (b)~     home-based supported exercise programs to see which program is most effective for men with~     PC on ADT. The investigators will also look at what motivates people to continue to exercise~     both during a structured program and after the program is complete and will examine which~     exercise program is most cost-effective.~      Participants (men with PC on ADT) will be recruited from one of the following cancer~     centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary,~     the Juravinski Cancer Centre in Hamilton, and the Southlake Regional Health Centre in~     Newmarket. When a patient agrees to participate, patient will be randomly placed in 1 of 2~     exercise programs. All programs will include the same type of exercises (aerobic, resistance~     and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day~     (as tolerated) for the length of the program (6 months). The investigators will look at how~     men with PC on ADT respond to the exercise program by measuring quality of life (QOL),~     fatigue and different physical measures before, during, and after the exercise program.~      Although the investigators know that supervised one-on-one exercise is most effective at~     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial~     and more financially responsible. This study will allow the investigators to begin to answer~     these questions so that structured exercise programs become a regular part of PC treatment.~   "
17032|NCT02834403|"~     This is a Phase Ib study assessing the maximum tolerated dose (MTD) and dose-limiting~     toxicities of L-NMMA when combined with docetaxel in refractory locally advanced or~     metastatic triple negative breast cancer patients. The study will be conducted in two~     stages. Stage 1 of the study will determine the MTD of L-NMMA when combined with 75 mg/m2~     docetaxel. Stage 2 of the study will determine the MTD of L-NMMA when combined with 60 mg/m2~     docetaxel. Five dose levels of L-NMMA (5, 7.5, 10, 12.5, and 15 mg/kg) will be investigated~     in stage 1. The starting dose of L-NMMA will be 7.5 mg/kg. As patients are accrued, a~     standard Bayesian model averaging continual reassessment method (CRM) approach will be used~     to determine the appropriate L-NMMA dosage. In stage 2, the starting dose will be one dose~     level above the MTD determined in stage 1. Again the CRM will be used to determine the~     appropriate L-NMMA dosage.~   "
17040|NCT02834299|"~     This study will compare unguided and guided dialectical behavior therapy (DBT) self-help to~     an attention-placebo self-help control condition. Participants with binge eating disorder~     will be randomly assigned to one of the three self-help conditions for 12 weeks. Six guided~     self-help sessions will take place via secure video-calling. Assessments will take place~     before, mid-way through, and after the self-help program as well as at 3-month follow-up.~     Six guided self-help sessions will take place via secure video-calling.~   "
17041|NCT02834286|"~     The purpose of this study is to determine the response rate and response duration with the~     combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.~   "
17042|NCT02834273|"~     The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of~     morbidity, disability and stroke associated mortality Under-education about stroke may~     prevent people from recognizing symptoms early enough to seek immediate care.~      The studies reported on stroke patients managed in stroke center have shown that 39-42% of~     patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.~      The stroke patients are therefore a population at high risk for neurological events and~     cardiac vascular recurrence. However, no studies have evaluated the interest of the~     development of therapeutic workshops in stroke unit to educate patients about symptoms~     suggestive of stroke, risk factors and what to do in cases of stroke.~      Investigators assume that the setting up of a therapeutic education workshop in the stroke~     unit may allow a better understanding of the symptoms, risk factors and what to do following~     stroke. So there is a direct benefit to the patient represented by a better knowledge of~     stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced~     risk of recurrence.~      More generally, there is a real benefit to promote these messages to the public through the~     patient and his relatives~   "
17043|NCT02834260|"~     Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and~     constitute one of the main factors reducing graft survival. They mainly occur during the~     first 18 months. Prevention usually relies on a topical treatment with dexamethasone or~     prednisolone for standard risk patients. Eye drops are instilled three times a day during at~     least 3 months then tapered.~      OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone~     during several months. It is indicated for intravitreal injection to treat macular edema.~      The investigators hypothesized that this implant could be used after subconjunctival~     injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop~     instillations.~   "
17044|NCT02834247|"~     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended~     Phase 2 dose, safety and efficacy of TAK-659 in combination with nivolumab in participants~     with advanced solid tumors.~   "
17045|NCT02834234|"~     Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and~     nothing is known about molecular characteristics of this disease. As main cancers, genetic~     heterogeneity is probable. This genomic profiling associates Comparative Genomic~     Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a~     biomarker that could be used in the treatment of this rare disease. Corresponding~     histopathological and immunohistochemical report as all clinical data are available. All~     data with be merged to underline a few genes of interest on which we will focus our next~     investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was~     also described in pleural mesothelioma. Mutations in oncogenic drivers that could be~     targeted by specific therapy will be on particular interest in management of this rare~     disease with bad prognosis.~   "
17046|NCT02834221|"~     This study is designed to evaluate the use of real-time ultrasound-guided femoral~     venipuncture during pulmonary vein isolation for treating atrial fibrillation .~   "
17047|NCT02834208|"~     Schizophrenia is an invalidating psychiatric illness with a strong genetic component~     characterized by abnormal processing of emotional information. This alteration in emotion~     processing has been described in acute as well as in remission phases of the illness. It has~     also been found in healthy relatives of patients with schizophrenia and in subjects at high~     risk of psychosis. Thus, alterations in emotional information processing are not only linked~     to the prognosis but can also be considered as a marker of vulnerability of schizophrenia.~     In addition, schizophrenia patients differ from healthy controls in neural activity in brain~     regions implicated in emotions processing. However, interpretation of findings in patients~     is limited by confounding factors, such as antipsychotic treatments or alterations due to~     the course of illness. Also, there is no data concerning genetic factors (polymorphisms or~     gene expression) underlying these patterns of cerebral activation in emotion information~     processing.~      So, the main objective of this study is to compare the cerebral activity of schizophrenia~     patients to that of healthy siblings and healthy controls in an emotional processing task.~   "
17048|NCT02834195|"~     Cerebral palsy (CP) has been defined as a group of permanent disorders of the development~     of movement and posture causing activity limitation(s) that are attributed to~     non-progressive disturbances that occurred in the developing fetal or infant brain.~      Investigators previously developed two classification systems, one for the upper limb and~     one for the hand, based on 100 films of patients with cerebral palsy. Separate~     classifications were developed following an initial study in which investigators found no~     correlations between upper limb and hand patterns, meaning that specific upper limb patterns~     are not always associated with specific hand patterns. Thumb patterns were not included in~     these classifications since robust classifications already exist, moreover thumb patterns~     are independent from hand patterns.~      The aim is to evaluate the inter- and intra-rater reliability of two previously developed~     classifications of upper limb and hand patterns.~   "
17049|NCT02834182|"~     Theory of mind (TOM), a main component of social cognition processes, refers to the capacity~     to infer one's own and other person's mental states. Deficits in social cognition are found~     in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare~     the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy~     participants during the performance of a TOM task. Results may help to understand the neural~     bases of the impairments in social cognition in schizophrenia and bipolar disorder, which~     may in turn help to propose potential new psychosocial therapeutic approaches in these~     disorders.~   "
17142|NCT02832947|"~     Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8~     months after bariatric surgery~   "
17050|NCT02834169|"~     Despite advances in the management of and changes in clinical practice, little is known~     about the epidemiology, patterns of care and outcomes of rare peritoneal surface~     malignancies patients in France.~      In order to better understand the characteristics of rare peritoneal surface malignancies~     and to evaluate treatment strategies, the RENAPE registry aims at the collection of data~     from patients presenting with a rare peritoneal surface malignancy in France. Data will be~     entered prospectively in a specifically designed and secured web database.~      All RENAPE's centres and physicians are invited to register patients with a rare peritoneal~     surface malignancy diagnosis and to participate to the registry. Data will be evaluated~     within regular time frames, focusing on types of rare peritoneal surface malignancies,~     treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing~     to the better understanding of these rare cancers.~   "
17051|NCT02834156|"~     This protocol is a pilot study on standard care. The main goal is to assess the impact of~     positioning on lumbar puncture process especially on pain sensitivity in children.~      It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period~     is one year, and number of inclusions forecasted is about 30. Each patient will have one LP~     in a seated position and one in a lying position.~   "
17052|NCT02834143|"~     Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial~     disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there~     are no recent epidemiological data on morbidity and mortality of critical ischemia.~     Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and~     are not subject to a clear consensus.~      Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European~     working group) in a population of severe ischemia in patients in order to offer relevant~     simple and reproducible criteria. Secondly Investigators propose to monitor the medium and~     long term evolution of these patients ICC defined to clarify the prognosis.~      diagnostic criteria of the different societies:~        -  TASC: Transatlantic criteria: very characteristic pain, wound optional, variable~          hemodynamic criteria as the presence of a wound or not~        -  VALMI: French criteria derived vascular medical college: characteristic pain, sore,~          hemodynamic reproducible, reliable criteria~        -  European working group: European definition of criteria, including a characteristic~          pain, requires no wound, different hemodynamic criteria of 2 others.~   "
17053|NCT02834130|"~     Severe forms of hemophilia and other constitutional bleeding disorders represent a group of~     rare diseases. In last decades, news therapies have dramatically increased life expectancy~     and joint's protection.~      The investigators propose to set up a single-centre, descriptive, transversal pilot study,~     designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or~     allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment~     Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the~     totality or part of the device accompanying the diagnostic announcement in the past 10~     years.~   "
17054|NCT02834117|"~     Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of~     infertility. This method is performed in presence of supernumerary embryo(s) after fresh~     transfer, or after freeze all embryos in case of medical reasons. It is necessary to control~     that the transfer is performed when the endometrium is receptive, which is essential for~     embryo implantation and pregnancy. This period is defined as the implantation window.~     Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate~     ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a~     natural cycle (NC). The objectives of this open randomized study is to compare the number of~     visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of~     life in both groups.~   "
17055|NCT02834104|"~     Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix~     remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions~     despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased~     myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present~     clinically with symptoms of cardiac failure although this is often a subclinical disease.~     Various imaging modalities and collagen biomarkers have been used as surrogate markers to~     assess the presence, extent, and turnover of myocardial fibrosis. Techniques using~     echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to~     detect early features of systolic and diastolic left ventricular dysfunction and impaired~     contractile reserve. Further identification of diffuse reactive fibrosis may be possible~     with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol~     is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification~     against histology as standard of reference.~   "
17056|NCT02834091|"~     The use of hypnosedation in the context of anesthesia is validated. This is a technique that~     combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with~     local anesthesia surgical site. It can favorably replace general anesthesia if surgery or~     endoscopy allows but doctors will always need local anesthesia surgical site where surgery~     The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to~     the operating room and in the various services of conventional and ambulatory~     hospitalizations.~      The goal of the investigators is to evaluate these parameters on a prospective cohort of~     patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or~     surgery.~   "
17075|NCT02833844|"~     The study is divided into 2 parts. The first part of the study will be double-blinded and~     will last for 24 weeks. During this time, subjects will be randomized in a ratio of 2:1 to~     receive either Repatha (evolocumab) QM or placebo QM.~      The second part of the study is a 24-week open label extension period. During this time all~     subjects will receive Repatha (evolocumab) QM.~      The clinical hypothesis is that subcutaneous Repatha (evolocumab) QM will be well tolerated~     and will result in greater reduction of LDL-C, defined as percent change from baseline at~     week 24, compared with placebo QM in HIV-positive subjects with hyperlipidemia or mixed~     dyslipidemia.~   "
17076|NCT02833831|"~     The primary objective of this study is to evaluate the effect of supratherapeutic exposures~     of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel~     2).~   "
18030|NCT02821351|"~     The primary objective of this study is to establish the safety and performance effectiveness~     of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic~     paroxysmal atrial fibrillation (PAF).~   "
17057|NCT02834078|"~     According to the International Diabetes Federation, one in every 12 individuals is a~     diabetic (about 8% of the world population). Major risk factors of diabetes are all the~     aspects of modern life which include obesity, over-weight, high-risk behavior like smoking,~     alcohol, multiple drug use-recreational or prescribed, environmental risk factors like~     inactivity and lack of exercise. However there is a window of opportunity between health and~     disease, which is pre-diabetes.~      Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance~     (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l~     and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.~      Though there are plenty of drugs available for significantly impaired glucose metabolism~     (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose~     metabolism is questionable due to risk of untoward hypoglycemia.~      On the other hand, herbal products like curcumin, as a single ingredient has poor~     bioavailability problem that restricts its use as standalone treatment. Inulin works as~     pre-biotic and help to maintain gut microbiota which is considered as precursor for progress~     of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of~     impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic~     gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on~     anti-oxidant pathways.~      None of these popular ingredients has been studied for their role in structural and~     functional health of pancreatic β cells which is very important for prediction of further~     progress of marginally impaired glucose metabolism to significantly impaired glucose~     metabolism.~      It is an unmet need to develop a product which not only improves insulin sensitivity, but~     also help to preserve the structural and functional health of pancreatic β cells. It also~     needs to improve overall metabolic and endothelial health of the person considering the~     close association between impaired glucose metabolism and these parameters.~      The proposed supplement - Berberine GlucoGold - is an improved version of successfully~     marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the~     ingredients complement each other in such a way that along with the individual role in~     glucose metabolism it also takes care of overall bioavailability and stability of the~     supplement. As per the previous data on ingredients, the supplement is also expected to~     preserve the structural and functional health of pancreatic β cells. The ingredients are~     also known to have positive effect on overall metabolic and endothelial health. Thus BGG has~     been developed to address the unmet needs in the area of glucose metabolism and overall~     metabolic health.~   "
17058|NCT02834065|"~     In this study the investigator will randomize 273 subjects to deep (<20°C), low~     (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with~     circulatory arrest. The primary purpose of this study is to determine the effect of deep vs~     low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and~     leukocyte SUMOylation patterns after surgical circulatory arrest in participants.~   "
17059|NCT02834052|"~     The main purpose of this study is to determine the dose of poly-ICLC that is safe and~     tolerable when it is combined with pembrolizumab in patients with colon cancer. This study~     will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune~     system in the patient's blood and inside the tumor; how it affects the size and number of~     tumor(s) in each patient; and how effective the combination is in patients with colon cancer~     that is unlikely to respond to pembrolizumab alone.~   "
17060|NCT02834039|"~     This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and~     tidal volume 10ml/kgBW in laparoscopic nephrectomy patients~   "
17061|NCT02834026|"~     Muscle strength can be measured by dynamometry, but the investigators did not find in the~     literature the study of this technique in the quadriceps of patients with chronic kidney~     disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps~     muscle strength in patients with chronic kidney disease during hemodialysis. This study will~     be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a~     university hospital, over 18 years, of both genders who underwent hemodialysis for more than~     six months and signed the consent form and enlightened. Patients will be divided into two~     groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics~     and quadriceps strength given by standardization of technique, with hard and windy belt. The~     control group will be reassessed after two months of the initial assessment, since the~     intervention group held two months of training in hemodialysis a physical therapy protocol~     with the cycle ergometer.~   "
17062|NCT02834013|"~     This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors.~     Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
17063|NCT02834000|"~     Continuous cardiovascular monitoring as part of management of high-risk surgical patients is~     widely practiced, however its role in low-risk surgical patients is unclear. Detailed~     monitoring of cardiovascular parameters from pre-induction stage allows clinicians to~     individualise anaesthetic management in the perioperative period. The investigators' aim was~     to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients~     undergoing surgery following induction of anaesthesia with propofol using a continuous~     non-invasive blood pressure device (LiDCOrapid™).~   "
17064|NCT02833987|"~     The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs)~     is associated with an increased risk of major bleeding compared to warfarin use, for the~     treatment of venous thromboembolism (VTE).~      The investigators will carry out separate population based cohort studies using health~     administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will~     be defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an~     incident diagnosis of VTE having occurred within 30 days prior to the date of the~     prescription for the DOAC or warfarin. Follow-up will continue until a hospitalization or~     emergency department visit for a major bleed. The results from separate sites will be~     combined to provide an overall assessment of the risk of major bleeding in DOAC users.~   "
17065|NCT02833974|"~     This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with~     intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks,~     will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic~     asthma.~      This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group,~     8-week treatment study.~      The study will consist of a screening period of up to approximately 4 weeks (involving two~     screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of~     up to 3 months. The total duration of the study for each subject will therefore be a maximum~     of approximately 6 months.~   "
17077|NCT02833818|"~     There are few scientific reports on preterm infants with birth weights between 1500 and~     2000g. Adequate and properly balanced supply of nutrients believed to better growth and~     cognitive development in this patient group, and optimized nutrition is an important part of~     treatment There is a need for more studies that can provide knowledge of growth and weight~     development in preterm and small for gestational age (SGA) infants with a birth weight~     between 1500 and 2000g.~   "
17078|NCT02833805|"~     Our primary objective is to determine if it is feasible for previously untreated severe~     aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and~     post transplantation cyclophosphamide.~   "
17066|NCT02833961|"~     Cerebral vascular disorder is one of the most fatal diseases despite current advances in~     medical science. The large number of negative clinical trials on neuroprotection in acute~     stroke is a pointer to the fact that translating better understanding of the pathogenesis~     and pathophysiology to clearly beneficial treatment strategies remains a daunting task. This~     project aims at elucidating the plausible biophysical events that affect water and~     metabolite diffusion in brain tissue after ischemia, by combining the information provided~     by two advanced methods of magnetic resonance (MR) diffusion imaging: diffusional kurtosis~     imaging and diffusion-weighted spectroscopy.~      Diffusion weighted imaging (DWI) has been established as a major tool for the early~     detection of stroke. However, information obtained using conventional DWI may be incomplete.~     Diffusional kurtosis (K) is a quantitative measure of the complexity or heterogeneity of the~     microenvironment in white and grey matter, which offers complementary information and may~     potentially be a more sensitive biomarker for probing pathophysiological changes. In~     addition, to gain more specific insights into molecular mobility in the intracellular~     environment, it is beneficial to assess the diffusion properties of metabolites, such as~     N-acetylaspartate (NAA), creatine and phosphocreatine (Cr), and choline containing compounds~     (Cho). Assessment of metabolite diffusion changes by diffusion-weighted spectroscopy (DWS)~     provides information specific to the intracellular environment. In particular, thanks to the~     specific compartmentation of NAA almost exclusively in neurons and of Cho in glial cells,~     the diffusion properties of these metabolites may provide specific insights into the~     pathological processes occurring independently in the two cell types. In addition, measuring~     a temporal profile of diffusion coefficient of these compounds may help clarify underlying~     pathophysiological changes in neuronal cells during acute ischemia.~      With the help of these two advanced methods, a proof-of-concept trial is proposed on 24~     healthy subjects and 24 ischemic stroke patients. Ischemic stroke patients will be scanned~     three times with a 3T MR scanner (before day 10 post-stroke, around week 4 and 3 months), in~     order to extract diffusion kurtosis imaging (DKI) and DWS metrics and understand the~     dynamics of the cellular mechanisms at play in cerebral ischemia. The goal of this study is~     to investigate neuronal and glial metabolite diffusion changes at different time points~     after ischemic stroke, in both infarcted and non-infarcted hemispheres. The aim is to get~     non-invasively important information on the evolution of the cellular damage in this~     disease, and possibly distinguishing between neuronal and glial processes (by measuring the~     metrics extracted for these two sequences), as well as on the different mechanisms leading~     to metabolite diffusion changes in the two brain areas, thus providing a great impact on the~     strategy of treatment for patients with cerebral infarction.~   "
17067|NCT02833948|"~     The aortic valve is located between the left ventricle and the aorta. Patients with~     symptomatic, severe aortic valve stenosis conventionally have it surgically replaced~     requiring direct access to the heart through the chest. Transcatheter aortic valve~     replacement (TAVR) is now a well-established alternative for treating severe aortic valve~     stenosis. Both types of intervention improve prognosis and alleviate symptoms.~      The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported~     that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been~     suggested to be potentially related with neurological events. In addition, the occurence of~     this phenomenon can be reduced with anticoagulation blood thinning therapy.~      The purpose of this study is to evaluate if anticoagulation compared to the usual double~     platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.~   "
17068|NCT02833935|"~     Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based~     tele-rehabilitation physical activity intervention aimed to enhance basic psychological~     needs, motivation, physical activity (PA), and quality of life- related outcomes of adults~     with spinal cord injury (SCI). It is anticipated that the individuals who receive the~     physical activity intervention (intervention group) will have moderate increases in their~     basic psychological needs, autonomous motivation, life satisfaction, and physical activity~     participation, and a moderate decrease in controlled motivation and depressive symptoms~     compared to the individuals who did not receive the intervention (control group).~   "
17069|NCT02833922|"~     The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal~     Timing (DOT), an app-based method of family planning that can be used via Android devices,~     for women who use the method to avoid pregnancy.~   "
17070|NCT02833909|"~     The objective is to investigate ex vivo the inflammatory response in hidradenitis~     suppurativa (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the~     skin of patients treated surgically for this disease.~      The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL)~     IL-17, could serve as a relay in the inflammatory process leading to HS severity and~     recurrences.~   "
17071|NCT02833896|"~     Medical context:~      Several molecular studies showed chromosomal alterations in patients with endometrial~     cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several~     genes of interest have been dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus~     conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX,~     MammaPrint), correlation between the tumor profile and life project in the case of cancer~     the endometrium could be done. A study is already underway at the Reims University Hospital~     with funding from the League against cancer and AOL in 2010 CHU Reims. It should identify~     the specific alterations of nosologic continuum of pathology and characterize areas of~     interest on the genome. To date, 39 patients with endometrial cancer and 15 patients with~     endometrial hyperplasia (patients 'cases') were included in the study. For this study, 10~     patients exhibiting neither cancer nor endometrial hyperplasia were also included. Samples~     of these 10 patients 'witnesses' were pooled to serve as a reference for analyzing patients~     'cases'.~      objectives: In continuation of the study began in November 2009, refine the study of genomic~     imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation~     between genomics and proteomics by immunohistochemical studies and analyzing the~     microsatellite instability.~      To study the prognostic role of genetic factors in patients carriers of a disease~     endometrial (cancer or hyperplasia).~      Material and methods :~      Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by~     a cohort study of patients 'cases'.~      Population / patients: in total, it is planned to include 72 patients with hyperplasia or~     endometrial cancer (22 patients included in the pre-study part funded by the League against~     cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).~      Plan of investigation: the study includes two phases:~      Sectional study:~      The inclusion of 10 patients witnesses has already been completed in the first project.~      During the consultation in the obstetrics and gynecology department of the Reims University~     Hospital and the surgical department of the institute Jean Godinot, terms and objectives of~     the study have been and will be presented to patients where cancer or hyperplasia~     endometrial was diagnosed by achieving endometrial biopsy.~      If the patient agrees to participate in the study, the management of its pathology~     (hysterectomy, hysteroscopy and curettage resection) will not be changed.~      The samples taken during the surgery were analyzed and will be as provided in the first~     research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A~     comparative genomic hybridization is conducted using the DNAs thus obtained.~      Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will~     be performed on all samples already obtained and on future withdrawals.~   "
17072|NCT02833883|"~     The main purpose of this study to define the good and/or bad effects of the combination of~     enzalutamide and CC-115 in patients with castration-resistant prostate cancer.~   "
17073|NCT02833870|"~     Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health~     challenge. Because of the limited effectiveness of pharmacological treatments, there is a~     growing interest in care approach based on nonpharmacological treatments, such as musical~     interventions. Several lines of evidence suggest that musical interventions could improve~     behaviour, emotion and even cognition in patients with AD. However, very few studies respond~     to the methodological constraints required for clinical controlled trials carried out in~     well selected groups of patients. The efficiency of such care approaches is not~     scientifically proved yet and the impact of musical interventions has rarely been compared~     to another pleasant intervention, leaving open the question about the specific benefits of~     music in patients with dementia. The main goal of this research project is to demonstrate~     short and longer-term efficiencies and the specificity of musical interventions in dementia~     by investigating their effects not only in patients but also in familial and professional~     caregivers.~   "
17079|NCT02833792|"~     STUDY OBJECTIVES~      Primary:~      To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem~     cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to~     subjects with mild to moderate dementia due to Alzheimer's disease.~      Secondary:~      To assess the preliminary efficacy of hMSCs versus placebo in subjects with~     Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric~     endpoints.~   "
17080|NCT02833779|"~     Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause~     of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree~     about which type of exercise is most appropriate. Manual Physiotherapy combined with guided~     exercise is a commonly applied clinical treatment, but no proof of its effectiveness has~     been shown. Clinical trials comparing results of treating subacromial syndrome of the~     shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher~     improvement, basically because patients suffered from chronic tendinitis and the treatment~     period lasted only two weeks. That is the reason why the investigators propose a long-term~     follow-up study and a more complete assessment of effectiveness of the exercise prescribed~     to improved this pathology.~      Objectives:~        -  Assessment of effectiveness of two different types of treatment of subacromial syndrome~          of the shoulder.~        -  Comparison of effectiveness of both treatments in order to select that one yielding~          better results as the one to be applied as a routine practice.~      Patients will be assigned one of the following treatments:~        -  Group 1: patients will be taught exercises in groups of six people, on a daily basis~          for twelve sessions.~        -  Group 2: patients will be taught the same exercise as Group 1, individually, and will~          receive manual therapy consisting of muscular and joint re-centering.~      A modified version of the Constant scale will be used to assess mobility and pain shoulder.~   "
17081|NCT02833766|"~     The main objective of the trial is to determine the efficacy of doxorubicin-loaded anti-EGFR~     immunoliposomes as first-line therapy in patients with advanced triple Negative, EGFR~     positive breast cancer. In this proof of concept trial, all patients will have an~     administration of the doxorubicin-loaded anti-EGFR immunoliposomes (anti-EGFR-IL-dox) every~     28 days, until progression or unacceptable toxicity.~   "
17082|NCT02833753|"~     This is a Phase I dose escalation study to determine how much chemotherapy can be safely~     administered into the abdomen while experiencing the fewest possible side effects.~   "
17083|NCT02833740|"~     The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of~     a set of three simplified mid-upper arm circumference classification devices (Click-MUAC)~     for use by mothers and caregivers to screen for acute malnutrition in young children. The~     study will be conducted in Isiolo County, Kenya. The study builds on the recent approach of~     training mothers to screen for acute malnutrition in their own children (mother MUAC~     approach).~      The primary aim of the study is to describe and compare the performance of a set of three~     prototype Click-MUAC devices against a gold standard of classification, in terms of measures~     of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the~     classification (diagnosis) of acute malnutrition. A secondary aim of the study is to~     determine the difference in agreement with the gold standard classification amongst~     mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular~     MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is~     equal to the gold standard of classification in terms of measures of agreement for the~     classification of acute malnutrition. A secondary hypothesis of the study is that agreement~     with the gold standard classification is better amongst mothers/caregivers using a~     Click-MUAC prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes~     of the study will be used to decide on whether production of a Click-MUAC device is~     desirable and, if this is the case, to select a design based on the performance of the~     prototype devices and the stated preferences of intended users.~   "
17084|NCT02833727|"~     Aim : To compare, among patients with an uncontrolled moderate to severe asthma, the blood~     eosinophil levels of smokers and non-smokers.~      Secondary aims: In uncontrolled moderate to severe asthmatic subjects, to compare between~     asthmatic smokers and non-smokers: sputum eosinophils counts, fractional exhaled nitric~     oxide (FeNO), pre and post bronchodilator Forced expiratory volume in one second (FEV1) /~     Forced vital capacity (FVC), Asthma-related quality of life, asthma exacerbations during the~     year preceding enrolment in the study, Medical direct and indirect costs related to asthma~     during the year preceding enrolment in the study, and adherence to asthma treatment during~     the year preceding enrolment in the study.~      Methods: Cross sectional observational study. Never-smoker and smoker asthmatics treated~     with at least 2 controller medications with a smoking history ≥10 pack/year with a ACQ score~     ≥ 1.5 points will be identified in the database RESP. Their clinical data will be matched to~     the Régie de l'assurance médicale du Quebec (RAMQ) and Maintenance et exploitation des~     données pour l'étude de la clientèle hospitalière (MED-ECHO) administrative databases and~     reMed (data on medications for patients with private health insurance) in order to access to~     data on medical services, hospitalisations and medications delivered by pharmacies. T~   "
17085|NCT02833714|"~     The purpose of this research is to characterize the effect of teriflunomide on the~     activation of B-cells, as well as its capacity to modify B-cell cytokine secretion. The~     in-vitro identified effects of teriflunomide on the expression of B-cell activation markers,~     costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then~     be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated~     with this medication.~   "
17086|NCT02833701|"~     This phase I trial studies the side effects and best dose of ascorbic acid when given~     together with bevacizumab in treating patients with high grade glioma that has come back~     (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of~     tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow~     the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work~     better in treating patients with high grade glioma.~   "
17120|NCT02833246|"~     This study is being done to determine if sending reminder text messages helps patients take~     their Oral Anticancer Medication (OAMs) when they are supposed to.~   "
17121|NCT02833233|"~     This study is being done to evaluate the safety of combining two strategies called~     cryoablation and immune therapy in women with curable early stage breast cancer.~   "
17087|NCT02833688|"~     To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During~     hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle~     maneuver. A few clinical studies had shown dexmedetomidine could reduce~     ischaemia/reperfusion (IR) injury caused by the secretion of reactive oxygen species and~     inflammatory cytokines. Glutathione-S-transferase (GST) was a sensitive and specific marker~     for hepatic injury in several studies before. So the investigator decided to use it as the~     primary endpoint. Besides, in our center, there are some liver resection surgeries that~     didn't need occlusion. So it can serve the best placebo for determine the the actual effect~     of dexmedetomidine on the IR injury in further subgroup analysis.~   "
17088|NCT02833675|"~     Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be~     evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE~     (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe~     prognosis. The distinction is based on clinical features (spontaneous crisis duration,~     presence of concomitant hives, atopic history...). Sometimes it could be difficult to make~     the difference. Nowadays, there is no biological marker of the crisis. The search for~     biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has~     identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and~     specificity of these markers.~      We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin~     during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or~     abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic~     etiology) at the time (day 0) and at distance from the crisis (D7).~   "
17089|NCT02833662|"~     Higher risk of cardiac and respiratory post-operative events is observed in patients with~     unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA~     screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia~     (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be~     compared with the research of arrhythmia, in order to show if they are linked to the~     hypoxemia events.~      Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and~     respiratory postoperative complications will be assessed in OSA patients.~   "
17090|NCT02833649|"~     To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to~     evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data~     preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable~     Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up~     from this standardized, multi-center clinical investigation, support from clinical and~     optical viewpoints TICL implantation, in stable keratoconus.~   "
17091|NCT02833636|"~     The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the~     clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score~     could evaluate the prognostic of recanalization of non-infarct-related coronary arteries~     (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI.~     The objectivity of current study was to assess the prognostic value of ACEF score in acute~     ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after~     successful primary PCI.~   "
17092|NCT02833623|"~     Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human~     population, resulting in high healthcare costs worldwide. However, H. pylori eradication~     rate is low nowadays and patients's compliance is one of the most important effective~     factors.~   "
17093|NCT02833610|"~     This research study is studying a possible therapy as a possible treatment for the~     consequences of Multiple Myeloma with renal insufficiency.~   "
17094|NCT02833597|"~     Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in~     arteriopathy when performing rowing on effort.~   "
17095|NCT02833584|"~     The purpose of this study is to determine whether regular dosage of paracetamol causes~     transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.~   "
17096|NCT02833558|"~     Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat~     superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered~     problem during submucosal dissection and is usually managed with electrocautery. However,~     this does carry a risk of deep thermal injury and perforation.~      PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent~     adherent barrier when applied to a bleeding point.~      The aim of this trial is to study the use of PuraStat® in reducing the need for thermal~     haemostasis during ESD.~   "
17097|NCT02833545|"~     Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single~     Center.~   "
17098|NCT02833532|"~     The purpose of this study is to evaluate non-inferial study of the after using Volus~     application, compared to the powerfill.~   "
17099|NCT02833519|"~     The purpose of this study is to examine the effect of supervised group exercise on mental~     wellbeing and signs of depression among pregnant women at risk of perinatal depression in a~     randomized controlled clinical trial.~      The investigators hypothesis is that 70 minutes of supervised group exercise twice a week~     for 12 weeks by pregnant women at risk of perinatal depression, will improve the~     participants mental wellbeing and reduce their symptoms of depression.~   "
17100|NCT02833506|"~     This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with~     MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal~     cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the~     immune system to find and kill tumor cells. Biological therapies, such as sirolimus, use~     substances made from living organisms that may stimulate or suppress the immune system in~     different ways and stop tumor cells from growing. Giving sirolimus and vaccine therapy may~     work betting in treating patients with ovarian, fallopian tube or primary peritoneal cancer.~   "
17101|NCT02833493|"~     The investigators aim to give an overview of Iron overload(IOL) of patients with AA and low~     and int-1 risk MDS and their sequelae under different chelation treatment. And the~     investigators also aim to evaluate the relationship of LIC and T2*/R2*.~   "
19723|NCT02799043|"~     A prospective, multicenter, randomized study to assess the safety and effectiveness of~     FIRM-guided procedures in conventional redo RF ablation procedures for the treatment of~     persistent and paroxysmal atrial fibrillation.~   "
17102|NCT02833480|"~     This study will evaluate the effects of budesonide (using Symbicort which is budesonide and~     formoterol) and fluticasone (using Advair which is fluticasone and salmeterol) on the airway~     microorganisms of patients with moderate-to-severe chronic obstructive pulmonary disease~     (COPD). This is a randomized, parallel group, two-centered clinical trial study to evaluate~     the effects of a 12 week treatment with Symbicort 400 mcg BID and Advair 250 mcg BID (via~     Diskus) on airway microbiota in patients with moderate-to-severe COPD. The control arm of~     this study will be Oxeze 12 ug BID.~   "
17103|NCT02833467|"~     Targeted next generation sequencing (NGS) provides a promising method for diagnostic~     purposes by enabling the simultaneous detection of multiple gene mutations. This study is to~     evaluate the feasibility and application value by using NGS into identifying genomic~     mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from~     surgical patients~   "
17104|NCT02833454|"~     The purpose of the study is to study the effect of anatomical direct insertion ACL~     reconstruction compared with conventional anatomical ACL reconstruction.~   "
17105|NCT02833441|"~     Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two~     consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be~     randomized to a community based peer counseling support group or clinic based standard of~     care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the~     efficacy of the intervention in improving adherence and virologic suppression.~   "
17106|NCT02833428|"~     The aim of this study was to analyze using an artificial intelligence engine (IA) the~     influence of the pathophysiological environment (set parametric monitoring data, imaging,~     biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish~     the principles of a new approach for studying spinal cord injury patients. It does not meet~     the usual criteria of clinical trials in so far as it does not test on patients the effect~     of a therapeutic~   "
17107|NCT02833415|"~     This study is a clinical study to investigate the gluconeogenesis pathway related to~     visceral adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects~     of empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using~     functional studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated~     nuclear magnetic resonance (NMR) spectroscopy platform.~   "
17108|NCT02833402|"~     Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency~     urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal~     incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves,~     thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of~     this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI~     remains unclear. Moreover, there are little data regarding specific patient characteristics~     that may serve as predictors for SNM success. Recent studies suggest that the bacterial~     community that lives in the urinary tract plays a role in the development and continuation~     of urinary symptoms. It is proposed that the urinary microbiome may change in women before~     and after SNM implantation and this study aims to describe these changes. Investigators in~     this study also hope to determine if differences in the urinary microbiome exist in women~     with a positive response to SNM treatment (responders) compared to those without symptom~     improvement (non-responders). This hypothesis will be tested by collecting urine samples as~     well as questionnaire and medical data from subjects with UUI that are already planning on~     undergoing SNM as part of clinical care before and after their SNM treatment.~   "
17109|NCT02833389|"~     This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     repeat dosing of UTTR1147A in patients with neuropathic diabetic foot ulcers that do not~     respond adequately to standard wound care. Patients across multiple sites will be assigned~     to one of the 4 cohorts (Cohort A, B, C and D) based on the eligibility criteria and~     randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12~     weeks, in addition to standard wound care.~   "
17110|NCT02833376|"~     Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most~     frequently performed procedures worldwide, and despite the advancements of medical~     equipment, remain dependent on experience and practice of the anesthesiologists. Although~     antisepsis takes part of the daily routine, there are still no solid scientific evidence of~     the most appropriate antiseptic for these procedures.~      Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin~     antisepsis for the neuraxial blocks.~      Methods: This is a clinical trial, a prospective, randomized study. There will be selected,~     consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly~     assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%,~     and to group B (n = 35), in which the antiseptic will be performed with the 0.5%~     chlorhexidine in alcoholic solution. Samples will be collected with swabs in an area of 25~     cm² for bacterial cultures three times: in pre-antisepsis moments, in the second minute~     after antisepsis, and immediately after the puncture. The number of colonies forming units~     per square centimeter (CFU / cm²) will be counted. The data will be analyzed statistically.~   "
17111|NCT02833363|"~     Helicobater pylori plays an important role in the development of gastric cancer. Eradication~     therapy can reducing the morbidity of gastric cancer, but can't totally prevent it~     especially when atrophy and more serious precancerous lesions already happened. Prior~     studies found the gastric bacterial difference among gastritis, intestinal metaplasia and~     gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted~     in the development of gastric cancer. The pathological change makes a more suitable~     environment for bacteria to overgrowth. This study are designed to analyze the gastric~     microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia,~     intraepithelial neoplasia and gastric cancer.~   "
17112|NCT02833350|"~     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active~     comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and~     safety of GDC-0853 in participants with moderate to severe active RA and an inadequate~     response to previous methotrexate therapy (Cohort 1) or methotrexate and tumor necrosis~     factor (TNF) therapy (Cohort 2).~   "
17417|NCT02829333|"~     The purpose of this study is to verify the effect of anesthetic technique on the change of~     postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to~     explore the potential impact of the anesthetic technique on leiomyomas recurrence and growth~     after the surgery of abdominal myomectomy.~   "
17113|NCT02833337|"~     Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are~     considered as the most challenging scenarios for implant-supported oral rehabilitation in~     modern implant dentistry. Therefore, a comprehensive and precise understanding of such~     anatomical structures are needed to avoid potential complications that ultimately might~     jeopardize the treatment outcome.~      Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such~     as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it~     offers a viable and reliable tool to study anatomical structures such as the posterior~     atrophic maxillae~   "
17114|NCT02833324|"~     This trial will investigate whether using reminder alarms with a wireless activity tracking~     device (Fitbit) will increase daily ambulation in individuals who have just had colorectal~     surgery.~   "
17115|NCT02833311|"~     Maintaining a healthy diet and engaging in routine physical activity may help decrease~     severity of symptoms, prevent secondary conditions, and slow functional decline in people~     with disabling neuromusculoskeletal conditions. However, people with these conditions face~     many health barriers to engaging in healthy behaviors. With the advent of portable~     technologies, such as smart phones, tablets and PDAs, there is a need to explore whether~     these technologies can help people with disabling conditions to stay motivated and overcome~     barriers to engaging in healthy behaviors.~   "
17116|NCT02833298|"~     Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV)~     infection in the United States have advanced liver disease. Patients with advanced~     fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are~     clinically cured of HCV continue to have an elevated risk of developing hepatocellular~     carcinoma (HCC). According to guidelines from several professional societies and from the~     American Association for the Study of Liver Diseases (AASLD), in particular, patients with~     advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC~     whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening~     has risen dramatically in recent years due to the confluence of three factors: Increased~     screening for HCV, which has allowed more people to realize that they have this often~     silent infection; the availability of safe and highly effective direct acting antiviral~     drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to~     achieve an SVR; and the long duration of HCV infection in many patients, which has allowed~     enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in~     the era of DAAs and to promote HCC screening, the objective of this study is to conduct a~     randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC~     screening between patients randomized to either personalized patient navigation or automated~     reminders (e.g. electronic or mailed). Both interventions represent improved care over~     current standard of care (no patient navigation or automated reminders). There is no~     evidence to suggest one intervention is better than the other. Healthcare providers who~     agree to participate in the study will be contacted to confirm the liver disease status of~     their patients and during the clinical trial the providers of patients in both arms of the~     trial will be sent reminders about the need to schedule patients for screening visits.~   "
17117|NCT02833285|"~     The inflammatory response involves many players from the immune response, including B~     lymphocytes. These cells are responsible for the synthesis of immunoglobulins in response to~     the presence of an antigen. They are characteristic of chronic inflammation. There are~     several subsets of B cells characterized by specific membrane markers. Once activated, these~     cells express many factors contributing to tissue destruction seen in periodontitis and~     particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-B ligand,~     tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and Monocyte~     Chemoattractant Protein-3).~      During the establishment of a periodontal disease, an important inflammatory infiltrate is~     observed in the gum. This infiltrate is characterized by the presence of many B lymphocytes.~     B cell subsets in the blood and the gum of patients with periodontitis have been little~     studied. However, the number of autoreactive B cells (cluster of differentiation (CD)19+,~     CD5+) has been reported to be higher in the blood of patients with periodontal disease. In~     the gum, the rate of B and T cells increases with the level of inflammation and is~     correlated with the severity of the inflammatory process. Activation of B cells is a~     prerequisite for the progression of gingivitis to periodontitis. B cell distribution could~     then be an indicator of disease progression, but also allow to study the response to~     treatment.~      The aim of this pilot study is to characterize B cell subsets in the blood and the gum of~     patients with periodontitis, according to disease activity. Analysis of B cells in the blood~     could highlight the association of a particular subpopulation with aggressive periodontal~     disease and evidence a particular biological profile of the host response. The investigators~     also wish to observe the evolution of this phenotype following an unconventional surgical~     therapy.~      This study would better understand the pathogenesis of periodontal disease and refine the~     diagnosis, prognosis and treatment of periodontitis, and thus participate in the development~     of personalized medicine. Biological monitoring of therapeutic effects may be initiated and~     allow more effectively prevent recurrence.~   "
17118|NCT02833272|"~     Inappropriate medication use among the elderly ranges from 11% to 62% and is a major concern~     for patient safety. Benzodiazepines account for approximately 20 to 25% of inappropriate~     medications prescribed to the elderly, thus reducing their inappropriate use could have a~     substantial impact on patient safety and overall well-being among elderly patients. The~     Choosing Wisely Canada- Geriatrics guidelines for high value health care recommend against~     the prescription of benzodiazepines or other sedative-hypnotics (Z drugs) in older adults as~     first choice for insomnia, agitation or delirium. Despite evidence of potential harms,~     benzodiazepines and non-benzodiazepine sedatives (including the Z-drugs: eszopiclone,~     zopiclone, zolpidem and zaleplon, henceforth referred to as sedatives) continue to be~     prescribed inappropriately to patients in hospital and community settings.~      Our primary objective is to facilitate the deprescription of benzodiazepine and~     non-benzodiazepine sedative hypnotics (sedatives) using a combination of physician education~     sessions and an updated patient educational pamphlet based on Tannenbaum's EMPOWER study~     conducted in a community-based setting.~   "
17119|NCT02833259|"~     From 10% to 30% of patients hospitalized with community-acquired pneumonia (CAP) are~     readmitted within 30 days of discharge. These readmissions have negative consequences for~     the patients and the hospitals where they are treated, including impaired quality of life,~     exposure to hospital-related adverse events, and increased resource utilization.~      Risk-adjusted readmission rates can be easily computed and tracked from computerized~     hospital discharge data, using validated models. As part of the Hospital Readmission~     Reduction Program (HRRP) effective in fiscal year 2013, United States hospitals with higher~     than expected 30-day readmission rates after pneumonia hospitalization have been subject to~     financial penalties from the Center for Medicare and Medicaid Services (CMS). The underlying~     logic of the HRRP is based upon the notion that short-term readmission is often a~     preventable adverse outcome, reflecting suboptimal quality of care during index~     hospitalization. Yet, published evidence suggests that less than one in four all-cause~     readmissions are deemed avoidable. Because only avoidable readmissions can be influenced by~     interventions designed to decrease readmission rates, avoidable readmission is a more~     relevant metric than all-cause readmission for tracking quality of hospital care for~     pneumonia.~      The purpose of this study is to develop an administrative data-based risk prediction model~     for identifying potentially avoidable readmissions within 30 days of discharge for patients~     hospitalized with CAP.~      R3P is a retrospective observational cohort study of consecutive adult patients discharged~     from two hospitals with a diagnosis code of CAP. Data sources include routinely collected~     hospital discharge data and retrospective chart reviews.~   "
17123|NCT02833207|"~     The growing population of obese adults is predicted to create a large public health burden~     in the next few decades. This study examines function of small blood vessels providing blood~     flow to skeletal muscles, to test if younger obese individuals (<40 years old, BMI >30) are~     already displaying reductions in blood vessel function. This study will test if the signals~     blood vessels use to increase blood flow are changing in these same subjects. Findings from~     this study may help create treatments to delay or prevent some of the negative effects of~     obesity on vascular health.~   "
17124|NCT02833194|"~     The primary objective of this study was to evaluate and compare the prevalence of the~     following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of~     women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical~     histories 10 years after their initial assessment/diagnosis.~        -  Mood disorders, including depressive episodes during the previous two weeks, recurrent~          depressive disorders at any point in life, dysthymia in the last two years, or any~          current or past manic episode;~        -  Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia~          with panic disorders, current social phobia, generalized anxiety in the last 6 months,~          or current posttraumatic stress syndrome;~        -  Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past~          or present (clinically validated),~        -  Current alcohol or drug problems (dependence or abuse).~   "
17125|NCT02833181|"~     The investigators propose to evaluate circadian variation of EEG using BIS (bispectral~     index) monitor in ICU patients in three different groups: non-sedated, only sedated and~     sedated and curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge~     frequency), bispectral index and EMG (electromyography) during 24 hours in admitted patients~     except acute neurological disease.~   "
17126|NCT02833168|"~     It is the aim of this project to develop and validate a German language screening~     questionnaire for symptoms of respiratory muscle weakness and sleep-disordered breathing~     (SDB) in patients with neuromuscular disorders.~   "
17127|NCT02833155|"~     The purpose of this study is to evaluate the safety and tolerance of entinostat administered~     orally as a single agent in a weekly dosing schedule. Additionally, this study will~     characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced~     breast cancer. And to define the profile of adverse events, including laboratory parameters~     in these subjects~   "
17128|NCT02833142|"~     The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B~     and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary~     objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess~     the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of~     BIIB033-A and BIIB033-B.~   "
17129|NCT02833129|"~     The purpose of this study is to assess the effect of playing high school football on later~     in life cognitive functioning and mental health. This is an observational study that will~     use data from the Wisconsin Longitudinal Study to compare high school football playing~     graduates in 1957 with comparable non-high school football playing graduates on cognitive~     functioning and mental health measures when participants are in their 60s.~   "
17130|NCT02833116|"~     This study evaluate the administration of epidural betamethasone versus dexamethasone for~     pain reduction, consumption of analgesic and quality of life. Half of the patient will~     receive dexametasone and the other half betametasone.~   "
17131|NCT02833103|"~     Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter~     of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common~     bile duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of~     life (QoL).The primary objective of this trial is to evaluate the efficacy of relieving~     abdominal pain of Pinaverium Bromide in medication therapy for patients with~     post-cholecystectomy SOD.~   "
17132|NCT02833090|"~     The goal of this study is to describe the increase in plasma serotonin or~     5-hydroxytryptamine (5-HT) in patient with increased severity of aortic stenosis and~     increased weight cardiac muscle.~   "
17133|NCT02833064|"~     Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the~     latter often associated with a poor outcome. To improve outcomes for these patients,~     clinicians need to develop a clearer understanding of the pathophysiology of this condition.~     Biomarkers and novel imaging techniques are vital to investigating and understanding the~     pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be~     eligible to take part in the study. The study will involve collection of biological samples~     (blood, urine, stool and breath) from included patients once daily for up to 7 days. For~     patients undergoing liver transplantation, a small sample of explanted (removed) liver~     tissue will be obtained. A small subgroup of patients with paracetamol induced acute liver~     failure will be eligible to be included in a pilot MRI (magnetic resonance imaging) study,~     which will involve two MRI scans during the first 7 days of their admission. All patients~     will be recruited from the Royal Infirmary of Edinburgh.~   "
17143|NCT02832934|"~     Coronary heart disease (CHD) are the leading causes of mortality and morbidity, particularly~     with the current context of an aging population. Prospective cohort studies, as well as~     analyses of pooled individual participant data suggest up to a 60-90% increase in the risk~     of CHD or HF events among adults with severe SHypo. However, no large randomized controlled~     trials (RCT) have assessed the impact of thyroid replacement on cardiovascular (CV) imaging~     outcomes. The goals of this proposal are to address the impact of thyroid replacement on~     subclinical atherosclerosis. The investigators will conduct a RCT in 185 patients with~     subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an~     average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities~     measured by carotid ultrasound at the close-out visit. Assessment of the impact of thyroid~     replacement on subclinical atherosclerosis within a trial will aid decisions and~     evidence-based guidelines development to treat a potential modifiable risk factor, such as~     SHypo.~   "
17144|NCT02832921|"~     The primary objective of this program is to apply a virtual reality (VR) cognitive-motor~     rehabilitation program to delay or slow cognitive decline of middle-aged adults who have a~     family history of Alzheimer's disease (AD) and thus are at particularly high risk of~     developing the disease.~   "
17134|NCT02833051|"~     The purpose of this project is to examine the effects of an acute bout of exercise on~     children's energy intake over the course of a day. Previous studies in adolescents and~     adults have shown exercise to be effective in decreasing short-term energy intake, with some~     variability. Individual characteristics such as habitual physical activity and psychological~     factors may influence the effect of exercise on energy intake, but these factors have yet to~     be examined. The investigators have assembled a multi-disciplinary team of researchers, with~     expertise in eating behavior, exercise, psychology, and clinical research in order to~     examine these questions. First, the investigators will examine the difference in energy~     intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise~     compared to 30 minutes of rest. Second, the investigators will collect objective measures of~     children's habitual physical activity, child characteristics (body composition, eating~     behavior traits), and individual responses to the controlled exercise bout. The~     investigators can then examine both group and individual differences in the energy intake~     response to exercise. Twenty children (ages 9-12) will be tested over the course of three~     visits. The key outcome will be differences in energy intake in response to exercise vs.~     rest. Secondary outcomes include the influence of differences in habitual physical activity,~     personal characteristics, and responses to the exercise bout on children's energy intake.~     The long term goal of this line of research is to understand the mechanisms behind the~     interaction between exercise and energy intake. The translational potential of this research~     will be to inform personalized childhood obesity prevention strategies in children at risk~     for overweight.~   "
17135|NCT02833038|"~     The primary purpose of this study is to investigate the effect of intravenous magnesium on~     blood pressure after Trendelenburg position during robot assisted prostatectomy.~      The secondary purpose of this study is to investigate the effect of intravenous magnesium on~     pain after robot assisted prostatectomy.~   "
17136|NCT02833025|"~     Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and~     mortality. Clot formation and clot stability are important factors in coagulation and~     hemostasis. As such platelet dysfunction and impaired thrombin generation play a central~     role in bleeding after cardiac surgery. The primary objective of this study is to evaluate~     the relationship between point-of-care determined platelet function and thrombin generation~     and postoperative bleeding in infants and young children undergoing cardiac surgery with~     cardiopulmonary bypass adjusting for clinically important confounding factors.~   "
17137|NCT02833012|"~     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of~     acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil,~     AC-1202, AC-1204, and Axona®.~   "
17138|NCT02832999|"~     This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes~     mellitus patients on oral glucose lowering agents, and naive to incretinomimetic.~     Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and~     arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day~     changes in insulin secretion and insulin sensitivity.~   "
17139|NCT02832986|"~     Herpes zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes~     zoster is caused by reactivation of the virus varicella zoster of latent infection in~     sensory ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset.~     However, the most common complication of herpes zoster is the post herpetic pain, which is~     usually defined as a persistent chronic pain for ≥ 3 months after rash onset. The risk of~     herpes zoster in life is 25-30%, but this figure rises to 50% among those aged ≥ 85 years.~     Similarly, the risk of experiencing post herpetic pain increases with age.~      Despite treatment with antiviral drugs, post herpetic pain has been reported in 10-20% of~     all patients with herpes zoster, but its incidence increases significantly in elderly~     patients over 60 years. It can be particularly harmful when it occurs on a particular field,~     elderly multiple pathologies, fragile and with multiple treatment. In this context of~     decompensation cascade greatly exacerbate the impact of the initial local disease.~     Ophthalmologic involvement is rare but clinically worrisome and generates significant costs.~   "
17140|NCT02832973|"~     A randomized clinical trial comparing sequential nephron blockage (SNB) with dual blockade~     of the renin-angiotensin system (RAAS) plus bisoprolol (DBB) in the treatment of resistant~     arterial hypertension (RH) was designed to investigate the importance of the SNB and the~     contribution of its volume component versus DBB and the importance of the serum renin in~     maintaining BP levels. This randomized trial with two treatment arms could help tailor~     therapy by identifying a more effective choice to control hypertension whether by acting on~     the control of volume or sodium balance, or by acting on the effects of the RAAS on the~     kidney.~      Methods - Participants: 80 patients undergoing treatment for RH with losartan (100-200 mg),~     chlorthalidone (25 mg), and amlodipine (5 mg) will be randomly divided into two groups after~     applying inclusion and exclusion criteria.~      Group 1: Sequential nephron blockade (SNB Group) n = 40 Group 2: Dual blockade of the RAAS~     plus bisoprolol (DBB Group) n = 40 Intervention: SNB consists in a progressive increase in~     sodium depletion. After the administration of a thiazide diuretic (chlorthalidone) and~     aldosterone receptor blocker, low doses of furosemide are administered and subsequently~     amiloride is prescribed to enhance the natriuretic effect.~      The dual blockade of the RAAS plus bisoprolol is used to increase the effect of angiotensin~     receptor 1 blockers (ARBs). Therapy then requires sequentially adding an angiotensin~     converting enzyme (ACE) inhibitor to reduce the levels of angiotensin (Ang) II resulting~     from blockage of the Ang II receptor and then to administer a beta-blocker to decrease the~     elevated renin secretion due to both the ACE inhibitors and ARBs Objective: This study,~     which compares two antihypertensive treatment regimens in patients with RH, has the~     following objectives: to demonstrate the therapeutic efficacy of SNB against DBB in RH~     patients, and to assess the side effects and adherence to treatment over 20 weeks of~     treatment.~      Enrollment: The eligibility criteria will follow those shown in the flowchart for the~     diagnosis of RH of the First Brazilian Position on RH.~      Patients will be excluded if they have: chronic renal failure, atrial~     fibrillation/atrioventricular block, contraindication to the drugs that will be used,~     refusal or failure to follow the regimen and secondary hypertension.~      Follow-up: Patients will be analyzed in five visits at intervals of 28 days for 20 weeks~   "
17141|NCT02832960|"~     Coronary heart disease (CHD) and heart failure (HF) are the leading causes of mortality and~     morbidity, particularly with the current context of an aging population. Prospective cohort~     studies, as well as analyses of pooled individual participant data suggest up to a 60-90%~     increase in the risk of CHD or HF events among adults with severe SHypo. However, no large~     randomized controlled trials (RCT) have assessed the impact of thyroid replacement on~     cardiovascular (CV) imaging outcomes. The goals of this proposal are to address the impact~     of thyroid replacement on cardiac function. The investigators will conduct a RCT in 185~     patients with subclinical hypothyroidism who will be randomly assigned to thyroxine or~     placebo with an average follow-up of 24 months from baseline. The main outcome will be CV~     imaging modalities measured by echocardiography at the close-out visit. Assessment of the~     impact of thyroid replacement on cardiac function and subclinical atherosclerosis within a~     trial will aid decisions and evidence-based guidelines development to treat a potential~     modifiable risk factor, such as SHypo.~   "
17145|NCT02832908|"~     Brain trauma is an important burden in traumatologic intensive care. In these patients the~     treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is~     difficult to assess the actual physiopathologic status of the brain. Changing the position~     of these patients (semi-seated to lying position) causes changes in the hémodynamics brain~     conditions, so in monitoring parameters . The analysis of these changes can givr us valuable~     clinically informations.~   "
17146|NCT02832895|"~     Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial~     cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury.~     The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral~     arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to~     detect a segmental lesion on the anterior cerebral arteries (ACA).~      The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA.~     However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not~     been yet determined.~      The goal of the present study is to determine the rate of detection of the ACA by using the~     FBW in patients with ABI in ICU.~   "
17147|NCT02832882|"~     In this study, the investigators are going to prospectively compare the clinical outcomes~     (technical success rate, 12 month local tumor progression rate, complication rate, tumor~     seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique~     for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method~     with the same device.~   "
17148|NCT02832869|"~     High quality bowel preparation is essential for successful colonoscopy. This study aimed to~     assess the impact of reinforced education by Wechat or short message service (SMS) on the~     quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled~     study was conducted. Reinforced education groups received additional education via reminders~     by Wechat or SMS 2 days before colonoscopy. The primary outcome was the quality of the bowel~     preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes~     included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective~     feelings of patients.~   "
17149|NCT02832856|"~     This evaluation will test the program effectiveness of a relationship education program~     (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on~     outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is~     more effective than a control curriculum of job-readiness programming, and 2) whether an~     abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson~     version.~   "
17150|NCT02832843|"~     The aim of this study was to elucidate genetic susceptibility of patients with~     nontuberculous mycobacterial lung disease using genome-wide association study.~   "
17151|NCT02832830|"~     The aim of this explorative trial is to verify the comparability of a fractionated intensity~     modulated radiotherapy with a conventional radiotherapy related to quality of life on the~     one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well~     as pain relief and local response for palliative patients with painful spinal bone~     metastases on the other hand. This is a single-center, prospective randomized controlled~     trial with parallel-group design to determine the quality of life after RT in patients with~     spinal bone metastases. Two different techniques were evaluated: intensity modulated~     radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each.~      Experimental intervention:~      IMRT 10 x 3 Gy~      Control intervention:~      3D-RT 10 x 3 Gy~   "
17152|NCT02832817|"~     Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units~     or perioperative. The mortality and morbidity increase for cardiovascular reason, due to~     hypoxia has been reported several times. It is therefore important to detect hypoxemia very~     early and with accuracy. The objective is to correct the causes quickly and thus avoid or~     minimize complications.~      In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen~     Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to~     the formation of free radicals, which in physiological condition are regulated by~     antioxidant mechanisms. However, in anesthesiology, it is common to find pathological~     situations (acute respiratory distress syndrome, shock, prolonged inflammatory state) where~     these regulatory mechanisms are overwhelmed. Oxygen administration to supra-physiological~     concentrations leads to a formation of excessive free radicals, aggravating the existing~     injury (including lung).~      Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and~     tolerance. Currently, the standard method for assessing oxygenation is the arterial blood~     gas analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial~     blood sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely~     unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen~     Saturation, called pulse oximeters. Pulse oximeters have become an integral and mandatory~     part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen~     Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their~     therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So~     pulse oximetry is a method considered reliable and especially non-invasive. It is less~     expensive and does not require blood sampling. These qualities explain why these devices are~     easily used in anesthesia, intensive care and in emergency situations.~      However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen~     Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is~     necessary to objectify the benefits and limitations of pulse oximetry to optimize their use,~     especially in these situations of high risk, where a discrepancy between the values measured~     by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be~     detrimental.~      It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a~     comparative study.~   "
17153|NCT02832804|"~     To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct~     current stimulation (tDCS) in the patients with primary chronic insomnia .~   "
17154|NCT02832791|"~     The purpose of this randomized study is to compare clinical and functional outcomes of both~     surgery techniques for anterior cruciate ligament reconstruction (using quadriceps tendon~     versus hamstring tendon) after reconstruction in athletes.~   "
17164|NCT02832661|"~     Biomargin is a European research program aimed at evaluating the diagnostic performance of~     biomarkers with respect to renal graft injuries, as well as their prognostic performance~     with respect to 3-year and 5-year graft outcomes.~      Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of~     individual kidney graft lesions will be determined systematically in urine and blood samples~     collected in patients from the time of transplantation onwards, as well as in the graft~     tissue when biopsies are required for medical causes or performed systematically in the~     investigation centres. Their diagnostic and prognostic performance will be checked against~     histological reading of the biopsies and evolution of the graft function over time.~   "
17178|NCT02832479|"~     Evolution of medical care for patients with cystic fibrosis appeared in recent years:~     prolongation of life expectancy with consequently increased comorbidities and the use of~     lung transplantation, systematic neonatal screening of new born since 2002, prescription of~     expensive new molecules or new presentation. This evolution justifies to realize an update~     of statistics of costs of care and to assess adherence to treatment~   "
17155|NCT02832778|"~     The purpose of the study is to measure the drug levels in the blood of HIV-infected~     individuals taking anti- HIV medication efavirenz 400 mg once daily in the presence of~     anti-TB medication rifampicin and isoniazid. The study is being run in two-stages - London~     (Stage 1) and Kampala (Stage 2).~      In London (Stage 1): HIV-1 infected patients (without tuberculosis infection) on established~     treatment with a combination based on 600 mg efavirenz dose will be recruited.~      In Kampala (Stage 2): Patients with both HIV-1 and tuberculosis infection being treated with~     600 mg efavirenz combination for HIV AND undergoing TB treatment with a dual therapy regimen~     contaning rifampicin and isoniazid will be recruited.~      Efavirenz-containing regimens are recommended as first-line therapy for HIV-TB co-infected~     patients. It has been shown there is a lack of a significant difference between efavirenz~     400 mg and efavirenz 600 mg, indicating that 400 mg efavirenz is non-inferior to the~     standard dose.~      The advantages of antiretroviral dose reductions may translate into greater benefits for~     more individuals infected by HIV globally, since they may allow access programs to reach~     higher numbers of infected patients and compensate for the finite global manufacturing~     capacity and increasing demand. For efavirenz, significant price reductions have been~     achieved through elimination of trade, logistics and manufacturing capacity barriers, and~     further price reductions could be achieved with a significant reduction in the cost of~     pharmaceutical ingredients. However, no data on the PK and effectiveness of efavirenz 400 mg~     once daily during TB treatment has been produced. Given that many patients on Efavirenz-~     based ART will need to be treated for TB during their lifetime and rifampicin is one of the~     most commonly used treatment for tuberculosis, it is important to study the reduced dose~     under carefully monitored conditions prior to roll out of a lower dose standard treatment.~     Therefore, we aim to investigate the PK of efavirenz 400 mg once daily in HIV-infected~     individuals in the presence of rifampicin and isoniazid in London, UK and in~     HIV/TB-co-infected individuals on dual anti-TB treatment in Kampala, Uganda~   "
17156|NCT02832765|"~     The primary goal of the study is to determine the local control-rate after radiotherapy (RT)~     with and without simultaneous integrated boost (SIB) concepts in patients with bone~     metastases of the spine. Further study objectives are survival, and clinical parameters such~     as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and~     consecutively an increased re-sclerotization of the bone metastasis due to a higher~     biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain~     relief and mobility.~   "
17157|NCT02832752|"~     The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region~     may improve the survival of young patients with sudden unexpected cardiac arrest.The primary~     aim of this study is to determine the benefit of the systematic integration of ECPR services~     into the out-of-hospital cardiac arrest management algorithm. This study is a controlled~     parallel group design with group allocation based on region of treatment. The investigators~     will compare the outcomes of ECPR-eligible patients in the intervention region, in~     comparison to patients meeting the same criteria in a comparable setting.~   "
17158|NCT02832739|"~     The aim of the USECARE AAL project is to improve and test SENACA, an ICT-based~     self-management support system for chronically ill patients and informal caregivers. 96~     end-users will be instructed to use SENACA for approx. 3 months (in Israel, Norway and~     Switzerland). Amongst others, clinical and behavioural outcomes will be recorded.~     Additionally, SENACA's usability will be evaluated to determine its potential future~     scalability.~   "
17159|NCT02832726|"~     The study investigates the absorption of different doses of hydroxocobalamin and~     cyanocobalamin in a vitamin B12-replete Danish population.~   "
17160|NCT02832713|"~     In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents~     35% of cases. It is thought that more than 2.5 million people older than 65 years have knee~     osteoarthritis.~      Currently, osteoarthritis management is based on three major axes:~        1. Non-pharmacological means, such as patient education, loss of weight and physical~          activity~        2. General pharmacological treatments: mainly paracetamol and then schedule II and III~          painkillers as well as nonsteroidal anti-inflammatory agent.~        3. Intra-articular pharmacological treatments:~             1. Intra-articular injections of corticosteroids: they are recommended during~               hydarthrotic flare-ups~             2. Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the~               absence of intra-articular effusion. However, their efficacy is questioned by most~               experts in the case of symptomatic knee osteoarthrosis.~        4. Sometimes, surgery is the only therapeutic option. However, besides the fact of~          exposing patients, who are sometimes frail, to several peri- and post-operative~          complications, the recovery rate (variable according to the prosthesis type and ranging~          from 5% to 25% at 9 years) in an ageing population justifies waiting as much as~          possible before surgery. Therefore, it is important to test new therapeutic options for~          symptomatic osteoarthrosis that will allow postponing the surgical treatment.~        5. The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative.~          BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the~          management of painful reactive periarticular muscle contractures. However, BoNT-A has~          also antalgic activity independently of the myorelaxant effect. This allows explaining~          in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six~          randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections~          of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee~          osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with~          a significant antalgic effect only in the groups treated with BoNT-A. No study has~          compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA~          in knee osteoarthritis and this is the aim of this trial.~   "
17161|NCT02832700|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has~     proven safe and with no influence on dietary intake. In a pilot study the investigators~     found, that orally administered CGMP seems to have a beneficial effect comparable to that of~     mesalazine in active distal ulcerative colitis.~      The investigators now wish to evaluate the effects in healthy subjects by studying the~     anti-inflammatory and microbiome modulating properties and by assessing possible changes in~     gastrointestinal symptoms.~   "
17162|NCT02832687|"~     Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose~     IV acetaminophen on patients' readiness for discharge. In doing so the investigators will~     also investigate the various factors that could potentially contribute to a patient's~     readiness for discharge such as overall opioid consumption, time to rescue medication,~     incidence of postoperative nausea and vomiting, pain scores, and perioperative stress~     markers and their overall correlation with IV acetaminophen intake.~   "
17163|NCT02832674|"~     A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and~     neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be~     enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the~     remainder will have a total of 5 study visits.~      All subjects will have a single treatment administered. The first 30 subjects will have an~     extra visit at Day 60 intended to allow collection of photo images post treatment to be used~     for the validation of three blinded raters.~      Photo images will be collected using 2D standard photography and 3D using the Vectra system.~     The architecture of the skin in the affected area will be measured using the Cutometer, a~     suction like instrument that measures elasticity. Sensory and safety will be measured using~     a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study~     duration is approximately 6 months.~   "
17176|NCT02832505|"~     This study has two major purposes:~        1. To test developed multiple anatomic and functional MRI methods;~        2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and~          monitoring of the progression of renal dysfunction.~      These purposes will be achieved by performing pilot studies with cohorts of patients.~   "
17165|NCT02832648|"~     This research aims to determine whether selenium supplements improve bone and muscle health~     in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken~     bones).~      Osteoporosis is a major public health problem. One in two women and one in five men over age~     50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women~     with below-average bone density around the time of the menopause might have previously taken~     hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side~     effects. Therefore there is a need for safe, effective and inexpensive preventative~     interventions for women at risk of osteoporosis.~      Selenium is a chemical nutrient present in several human proteins, including anti-oxidants.~     Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging~     reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil,~     and so is obtained from many foods. However, soil selenium levels are low in Europe, and~     dietary intake in the UK is below recommended levels.~      We previously found that women with higher blood selenium levels have stronger bones, but~     this doesn't prove that giving selenium will improve bone strength.~      The investigators propose a randomised controlled trial to compare selenium supplements with~     a placebo (dummy treatment) in women with below-average bone density. The investigators will~     give selenium (at two different doses) or placebo to 120 women for six months and use blood~     and urine tests and bone density scans to see if giving selenium does have any effect on~     bone. The investigators will also do muscle function tests and measurements of free radical~     molecules.~   "
17166|NCT02832635|"~     The purpose of this study is to evaluate the effects on neurocognitive function of~     whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of~     hippocampus for patients of brain metastases, as well as the feasibility and risk of~     avoidance of hippocampus during whole-brain radiotherapy.~   "
17167|NCT02832622|"~     This is a prospective, multicenter, non-randomized registry/observational study. The study~     will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac~     Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT~     implantation.~   "
17168|NCT02832609|"~     The purpose of this study is to study the role of closing volume as a determinant of~     orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in~     closing volume in supine position would be greater in orthopneic than in non-orthopneic~     subjects, and (2) the relationship of change in closing volume to change in dyspnea with~     position would be dependent on expiratory flow limitation in the sitting position.~      In stable obese subjects, in sitting and supine positions, the investigators measured Borg~     dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen~     expiration test, from which the investigators determined closing volume and closing~     capacity, slope of phase III, and opening capacity.~      Orthopnea was defined as any increase in the Borg score in the supine position from its~     value in the sitting position~   "
17169|NCT02832596|"~     The arterial blood pressure is thought to affect the ratio between filtration and~     reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During~     induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the~     plasma volume increases. The aim of the study is to evaluate weather a maintained blood~     pressure with norepinephrine during anesthesia induction reduces the increase in 125~     iodine-labeled human serum albumine (125I-HSA) measured plasma volume.~   "
17170|NCT02832583|"~     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich~     Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin~     rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions~     4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months~     after the last injection session. Safety was assessed by reported adverse event analysis.~   "
17171|NCT02832570|"~     Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on~     treadmill of PAD patients with claudication~   "
17172|NCT02832557|"~     The goal of this study is to identify miRNAs that are at increased or decreased levels in~     the saliva of children with autism spectrum disorder (ASD) or developmental delay and would~     be useful biomarkers for the screening of toddlers and young children for ASD. These~     biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us~     to understand some of the changes in the brains of autistic children.~   "
17173|NCT02832544|"~     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD),~     Atrial fibrillation (AF)/flutter and stroke.~      A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus~     standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to~     VKA, with testing for superiority if non-inferiority is satisfied.~   "
17174|NCT02832531|"~     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD),~     Atrial fibrillation (AF)/flutter and stroke.~      A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in~     high risk patients either with AF and unsuitable for VKA or without AF and with high risk~     factors.~   "
17175|NCT02832518|"~     The incidence and prevalence of dialysis in Taiwan remains higher as compared to past~     several years. The number of dialysis reported about 6-7 million people each year and the~     2014 full-year cost estimation was about 330 million NTDs. According to age-standardized~     population statistics in 1995, the number of dialysis per million population in 2006 year~     were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent~     recorded.~      EarlySense system is certified by TFDA, FDA and many other countries, which consists of~     mainly two parts. One for the sensing element, which placed under the mattress and the other~     one is AC-powered display panel bed. This system has the ability to monitor the patients~     physiological functions just be in contact via bed. When the patient laid on bed, the sensor~     which is placed under the bed would detects heart rate, breathing rate and activity level as~     well as other physiological signals. The system is also able to distinguish between patients~     in bed and out of bed during the operation to save the patient's records and information~     (including heart rate, respiratory rate and level of activity, and may render trends). The~     system is also have capability for real-time data transmission information which includes a~     warning to the nurses' station or other monitoring center of the screen by providing~     real-time information to nurse.~      In this research project, we will use EarlySense equipment for continuous monitoring the~     dialysis patient's physiological data along with clinical data such as A. acute~     complications such as rapid changes in blood pressure, respiratory rate, movements of~     patients and Nausea or vomiting, etc phenomenon's) B. Lab examination data C. Status of~     patient whether patients hospitalized or not and patient death occurred or not. The study is~     expected to have a pilot study for more than three months' duration. Through this EarlySense~     continuous monitoring and gather the data, we will analyse to develop a prediction model and~     confirmed with indicators. Evidences from these analytics would help to propose ways to~     improve it and implement Positive predictive validity models.~   "
17179|NCT02832466|"~     Patients undergoing haemodialysis present a decrease in physical function, but little is~     known about the rate at which function decreases.~      The purpose of this study is quantifying the nature and degree of functional deterioration~     experienced by stage 5 chronic kidney disease patients during a six month period of~     maintenance haemodialysis therapy.~   "
17180|NCT02832453|"~     The purpose of this study is evaluate the effectiveness of different doses of supervised~     exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care~     intervention tool for the management of the metabolic syndrome in low active adults with one~     or more metabolic risk factors.~      Secondary aims of the study are to investigate the effects of these interventions on~     systemic inflammation and adipose tissue function, cardiorespiratory fitness, physical~     activity and sedentary habits, and the cost-effectiveness of the intervention with regard to~     health related quality of life.~      The general hypothesis is that adults with risk factors for metabolic syndrome participating~     in interventions for the promotion of a healthy lifestyle that together with counselling~     strategies will include supervised physical exercise of vigorous intensity will present~     greater improvements in terms of metabolic risk, physical condition, physical~     activity/sedentary behaviours and psychological parameters at the end of the intervention~     and at 6-months follow-up than participants in interventions for the promotion of a healthy~     lifestyle that will include counselling plus physical exercise of low-to-moderate intensity~     or interventions based exclusively on counselling.~      It is a three arms controlled randomized clinical trial implemented in the Primary Health~     Care setting and of 10 months duration.~   "
17181|NCT02832440|"~     Although exercise training of haemodialysis patients is associated with generally positive~     outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is~     often related to financial cost and/or staffing limitations. Home-based programs could be an~     alternative means of providing exercise benefits without associated implementation costs The~     aim of this study was to compare the effects of 4 weeks intradialytic versus home based~     exercise for haemodialysis patients regarding adherence and strength gains.~   "
17182|NCT02832427|"~     Although the first outpatient review following cardiac surgery is conventionally scheduled~     for six weeks after hospital discharge, there is no evidence to support this practice.~     Thirty-day mortality and morbidity rates, which are now widely used as indicators of the~     quality of surgical care, reveal rates that are higher than corresponding in-hospital rates.~     Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are~     not known. The objectives of our study are to determine the postoperative mortality and~     morbidity rates in the 6-week interval between hospital discharge and the first planned~     specialist review after cardiac surgery, and to assess the level of patient satisfaction~     with current practice.~      The study will enrol eligible patients who are undergoing elective and urgent coronary~     artery bypass and/or valve surgery at our institution over a 6-month period and provide them~     with study information. Prior to discharge after surgery, prospective participants will be~     consented and given a questionnaire to take home, complete and bring along to the outpatient~     appointment.~      The investigators will analyse the data to determine the rates and timing of the~     complications, and the impact on postoperative recovery. The investigators will also assess~     the level of patient satisfaction with the current practice.~      Appropriate conclusions either in support of current practice or, a change in practice would~     be drawn..~   "
17183|NCT02832414|"~     The purpose of this study is to determine if a lifestyle change program for obese patients~     who are already receiving continuous positive airway pressure (CPAP) treatment can achieve~     weight loss and overall improvement of obstructive sleep apnea syndrome (OSAS).~   "
17184|NCT02832401|"~     Caffeine is the most used psychoactive drug in Canada, with regular consumption by 88% of~     the adult population, While rates of caffeine consumption are considered to be high in the~     general population, there is some evidence that they may be even higher within schizophrenia~     patients; in a 2006 U.S. study, daily consumption rates of caffeine were nearly double those~     observed in a healthy control population (471.6 mg/day vs. 254.2 mg/day). Furthermore, 13%~     of the schizophrenia population studied ingested more than 1000 mg/day of caffeine, well~     above the 400 mg daily maximum recommended by Health Canada. High doses of caffeine are~     particularly concerning for individuals with schizophrenia; caffeine alters dopaminergic~     activity at post-synaptic neurons through its actions at adenosine A2A receptors, which may~     exacerbate positive symptoms, such as delusions and hallucination. This significant rate of~     consumption is likely due in part to caffeine's actions on the human brain, resulting in~     increased arousal, elevated mood and beneficial effects on a wide-range of cognitive~     processes including verbal working memory, sustained attention, and executive function.~     These areas of caffeine-induced cognitive improvement notably overlap with the cognitive~     domains that are reported to be diminished in schizophrenia. Despite this overlap and the~     rates of caffeine consumption observed within schizophrenia, research reports examining the~     effects of caffeine on cognition and brain activity are all but non-existent in this~     population. The primary objective of this proposal is to compare the effects of caffeine and~     placebo on brain function during cognitive tasks in participants with schizophrenia. While~     the investigators have specific hypotheses for each task, overall the investigators~     hypothesize that caffeine will improve cognitive function (as evidenced by larger ERP~     amplitudes and/or reduced ERP latencies) compared to placebo in schizophrenia patients, with~     similar effects (albeit reduced in magnitude) observed in non-patient healthy controls.~   "
17185|NCT02832388|"~     In this study the investigators aim to identify and include all patients with Primary~     Aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the~     characteristics of these patients, to explore the cardiac effects of PA, and to identify the~     long-term patient outcome after treatment. A subgroup of the included PA-patients perform~     Cardiac MRI to assess myocardial function in rest and during stress, myocardial mass and~     myocardial fibrosis, compared to a group of healthy controls.~   "
17186|NCT02832375|"~     This single center, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice.~   "
17187|NCT02832362|"~     This will be a single-center, randomized, parallel-group, placebo-controlled study to assess~     the local nasal tolerability and safety of multiple administrations of topically~     (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult~     participants~   "
17188|NCT02832349|"~     The Epilepsy Patient Education (EPE) is very important for the comprehension of the disease~     and its management. The EPE allows patients and caregivers to acquire together some autonomy~     and some skills that will help them live better with the disease.The primary objective of~     this study is to evaluate the impact of a program of educational activities (EA) on the~     quality of life of epileptic patients measured by the validated scale Quality Of Life in~     Epilepsy -31 (QOLIE-31).Investigators hope a difference in improving the quality of life~     score of 25% between the 2 groups.~   "
17189|NCT02832336|"~     Caffeine may be playing a beneficial role in patients with narcolepsy. However, the~     relationship between caffeine and its effects on narcoleptic patients has not been examined,~     and it is also unclear whether caffeine provides a beneficial effect or not. Hence, the aim~     of this study is to assess the effects of caffeine consumption on daytime sleepiness and~     reaction time in narcoleptic patients.~   "
17190|NCT02832323|"~     Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through~     erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the~     hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to~     reach this target depends on numerous and imbricated factors such as age, associated~     pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO~     response and Hemoglobin (Hb) level is currently the only and late tool to assess the~     efficacy.~   "
17191|NCT02832310|"~     The aim of this study is to determine the relation between arterial diameter and flow of~     carotis interna, brachial artery and radial artery before and after valsalva maneuver.~   "
17192|NCT02832297|"~     In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 265~     biologic-naïve subjects with RA who are candidates for treatment intensification due to~     inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.~   "
17193|NCT02831244|"~     The purpose of this study is to evaluate the performance of the Agili-CTM implant in the~     treatment of osteoarthritis of the Great Toe.~   "
17194|NCT02831231|"~     This study is intended to determine whether the addition of trospium chloride to xanomeline~     tartrate will ameliorate the peripheral cholinergic side effects that have been previously~     experienced with xanomeline tartrate when administered alone.~   "
17195|NCT02831218|"~     The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary~     angiography)-guided and imaging-guided strategy in patients with native coronary artery~     disease undergoing Bioresorbable Vascular Scaffold implantation.~   "
17196|NCT02831205|"~     The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is~     non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to~     target-lesion failure (TLF) at 1 year.~   "
17197|NCT02831192|"~     The purpose of this study is to see whether HLA-mismatched donor cells infusion with~     chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve~     survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a~     prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and~     toxicities.~   "
17198|NCT02831179|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has~     spread to other places in the body and usually cannot be cured or controlled with treatment,~     has returned after a period of improvement, and cannot be removed by surgery. Veliparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading.~   "
17199|NCT02831166|"~     Primary percutaneous coronary intervention represents the gold standard for the treatment of~     ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are~     associated with an increased risk of mortality, re-infarction, and stroke. Although the~     prognostic value of access site related bleeding complications is still debated, transradial~     approach is associated with better short-term outcomes and reduced hospital stay as compared~     to transfemoral approach. The investigators aimed to compare transradial approach with~     transfemoral approach with systematic achievement of hemostasis by the implantation of a~     vascular closure device in a national multicentre randomized clinical trial.~   "
17200|NCT02831153|"~     This study evaluates the effects of emotional status on coronary flow in patients undergoing~     elective coronary angiography. Patients whom undergoing elective coronary angiography will~     fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety~     Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled~     both before the intervention and after 1 hour the patients learned the results of the~     coronary angiography. The other scales will be performed after 1 hour the patients learned~     their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial~     Infarction) frame count method.~   "
17201|NCT02831140|"~     This prospective, randomized study is designed to evaluate the effectiveness of~     postoperative care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison~     with the traditional postoperative care.~      In order to conduct this study, patients having a thoracic surgery will be randomly~     attributed to FTR protocol group or control group.~   "
17202|NCT02831127|"~     Plastic and covered metal stents need to be removed or exchanged within appropriate time in~     case of undesirable complications. However, it is not uncommon that patients does not follow~     the recommendation for further stent management after ERCP. we hopothesized that short~     message service (SMS) intervention monthly could improve the adherence in patients with~     benign pancreaticobiliary after ERCP.~   "
17203|NCT02831114|"~     Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane~     chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is~     difficult and at this time conventional treatment is primarily limited to the global use of~     antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom~     improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus;~     however, few studies have evaluated acupuncture as a viable treatment for taxane induced~     peripheral neuropathy. This study will enroll female breast cancer survivors at the~     Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship~     to assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences~     the mechanisms underlying resolution of TIPN. This would provide critical validation of~     acupuncture and increase potential for other forms of chemotherapy induced peripheral~     neuropathy.~   "
17204|NCT02832271|"~     The purpose of the study is to evaluate the efficacy and safety of green tea in~     endometriosis.~   "
17229|NCT02831946|"~     To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure~     at cesarean section (CS) on long-term cosmetic and maternal outcome.~   "
17205|NCT02832258|"~     Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae~     (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of~     antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal~     treatment of E-ESBL is nearly impossible at this time.~      Our aim was to describe the characteristics and treatments of urinary tract infections~     caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.~   "
17206|NCT02832245|"~     The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a~     multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive~     data registry of consecutive patients with venous thromboembolism.~      The main objective is to provide information on the Internet to help physicians to improve~     their knowledge on the natural history of thromboembolic disease, particularly in those~     subgroups of patients who are usually not recruited in randomized clinical trials (pregnant~     women, elderly patients, disseminated cancer, severe renal insufficiency, patients with~     contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of~     decreasing mortality, frequency of thromboembolic recurrences as well as bleeding~     complications and arterial events.~      As an additional objective RIETE is also aimed to create predictive scores that help~     physicians to better identify patients with high risk of presenting some of these~     complications.~      The primary parameters recorded by the registry comprise details of each patient's clinical~     status, including any coexisting or underlying conditions, and the type, dose, duration and~     outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints~     are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor~     bleeding complications, and death.~   "
17207|NCT02832232|"~     There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy,~     for treatment of patients with chronic neck pain. In our clinical practice, a favorable~     effect is observed on patients with chronic neck pain, but there are no published studies~     evaluating the results of this techniques on pain, mobility and disability.~      The objective of this trial is to evaluate if the suboccipital manual techniques, provides~     further improvement in pain intensity, neck disability, range of motion, on patients with~     chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated~     with physiotherapy. For this purpose, investigators conduct a double-blind (patient and~     evaluator) randomized controlled trial, in a Public Primary Care Center.~      Seventy four subjects will be randomized (computer application) into three groups:~     Mobilization Group, Maintained pressure Group and Control Group. All the three groups~     receive the same protocolized physiotherapeutic treatment during three weeks and,~     additionally, the Mobilization Group receives six sessions (two sessions in a week during~     three weeks) of translational dorsal glide mobilization technique grade III of the~     atlanto-occipital joint and the Maintained pressure Group receives six sessions (two~     sessions in a week during three weeks) of pressure maintained suboccipital Inhibition~     technique. The Control Group receives the protocolized physiotherapeutic treatment only.~      Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured~     at baseline, after treatment period, and three months after discharge from treatment. After~     discharge for treatment the patient subjective opinion about their evolution will be~     collected through a Global Rating of Change (GROC) scale, and evaluation of headache~     disability (HIT-6).~   "
17208|NCT02832219|"~     Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet~     no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity~     in humans. In this double blind, placebo-controlled, crossover pilot trial, the~     investigators will evaluate the effects of H2 intervention on body composition, hormonal~     status, and mitochondrial function in middle age overweight women, with hydrogen~     administered orally for 4 weeks.~   "
17209|NCT02832206|"~     This study evaluates in detail efficacy and safety (including neurological safety) of hybrid~     ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF).~     An implantable ECG monitor will be implanted to all patients for rhythm monitoring.~     Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological~     examination and periprocedural transcranial Doppler measurement.~   "
17210|NCT02832193|"~     Data on how to avoid POCD are limited. The purpose of this monocentric parallel - grouped~     observational registry is to collect study data of the incidence of postoperative cognitive~     dysfunction (POCD).~   "
17211|NCT02832180|"~     This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of~     child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the~     pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and~     Norethindrone Acetate.~   "
17212|NCT02832167|"~     The purpose of this study is to determine whether Nivolumab is an effective treatment for~     advanced or metastatic cancer. The study will evaluate the clinical benefit rate of~     Nivolumab in subjects at 16 weeks from enrollment. Various advanced or metastatic tumor~     types are eligible for enrollment. Subjects must have received prior standard of care~     treatment for their cancer before enrollment.~   "
17213|NCT02832154|"~     This pilot clinical trial studies how well an internet-delivered positive affect (PA)~     intervention works in managing emotion in young adult cancer survivors. An~     internet-delivered PA intervention may teach younger cancer survivors healthy coping skills~     and help doctors to learn more about what effects mood may have on the health and well-being~     of young adults with cancer.~   "
17214|NCT02832141|"~     This pilot study aims to i) represents the feasibility of the study design and ii) to point~     out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the~     sympathetic nervous system.~   "
17215|NCT02832128|"~     The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide~     an indication of improvement in performance of tests across a battery of speech and hearing~     assessments in cochlear implant users.~   "
17230|NCT02831933|"~     This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and~     stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before~     nivolumab in patients with metastatic squamous and non-squamous non-small cell lung~     carcinoma (NSCLC). In situ gene therapy will consist of adenovirus-mediated expression of~     herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.~   "
17216|NCT02832115|"~     The primary objective of the study is to determine the role of transdermal vasodilators as~     an adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient~     comfort, and post procedure radial artery patency during transradial coronary angiograms and~     interventions. The study hypothesis is that transdermal vasodilators will increase radial~     artery size and reduce radial artery spasm as well as improve patient comfort and post~     procedure radial artery patency. This is a single-center, double-blind, randomized,~     placebo-controlled study comparing the effect of transdermal preparations of lidocaine +~     nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing~     transdermal coronary angiograms. Prior to the procedure, each patient will be randomized~     into either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.~   "
17217|NCT02832102|"~     The purpose of this study is to determine new multiscale signatures for the prediction of~     head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage~     III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for~     overall survival.~   "
17218|NCT02832089|"~     Oral carvedilol administered in escalating doses in patients with atrial fibrillation among~     patients with AF with fast ventricular rate.~   "
17219|NCT02832076|"~     The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed~     for 10 days on wound healing in female obese patients undergoing midline exploratory~     laparotomies for ovarian cancer.~   "
17220|NCT02832063|"~     The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244~     administered over 12 weeks to participants with mild to moderate acne vulgaris relative to~     placebo.~   "
17221|NCT02832050|"~     Study synopsis Objectives~        -  To determine whether delivering a semi-structured play therapy intervention can improve~          procedure-related anxiety / ability to cope with a procedure / procedure-related pain~          for children and young people.~        -  To determine whether delivering a semi-structured play therapy intervention can improve~          patient experience of blood monitoring.~      Patients~        -  Patients aged 5 - 17 years who are under the care of the rheumatology team.~        -  Patients expected to require at least two blood tests during a 12 week period. Design~        -  Recruitment over 24 weeks with each child in the study for a 12 week period.~        -  20 patients will receive play therapy intervention as outlined in the play therapy~          intervention for blood tests.~        -  20 patients will be the comparator group. They will be offered standard care for blood~          tests.~        -  All children will be offered local anaesthetic cream for each blood test. Blood tests~          will be performed by venepuncture unless specifically requested otherwise by patient.~        -  All children will complete outcome measures at baseline, beginning and end of each~          procedure session and at completion of the study at 16 weeks.~      Outcome Measures~        -  Procedure-related anxiety visual analogue scale (VAS) score - completed by child~        -  Observer procedure-related anxiety VAS score - completed by parent~        -  Procedure-related coping VAS score - completed by child~        -  Procedure-related pain VAS score - completed by child~        -  Patient experience VAS score - completed by child and parent separately~   "
17222|NCT02832037|"~     The objective of the study is to investigate the efficacy, safety and pharmacokinetics of~     four different doses of BI 425809 once daily compared to placebo given for 12 weeks in~     patients with schizophrenia on stable antipsychotic treatment.~   "
17223|NCT02832024|"~     This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to~     Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).~   "
17224|NCT02832011|"~     This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged,~     below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin~     or olive-oil fortified breast milk. Cases will receive same amount of calorie intake either~     with eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil~     doesn't increase proinflammatory cytokines and grant enough weight gain in premature infants~     at the end of the study, investigators will suggest olive oil to replace eoprotin which is a~     very costly breast milk-fortifier.~   "
17225|NCT02831998|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP~     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
17226|NCT02831985|"~     A large number of children with otitis media undergo surgery with ventilation tubes (VTs)~     placed in the tympanic membrane. This is done to improve hearing and speech development and~     to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is~     required to assure that the tubes are functional, hearing loss has been corrected, and~     potential complications are properly diagnosed and managed. Guidelines regarding follow-up~     care give different advices concerning when, how and by whom the controls should be made.~      The primary goal of this study is to investigate if follow-up care after surgery with VTs of~     children aged 2-12 years can be done by general practitioners instead of specialists without~     negative consequences for the patient.~      In the study the child`s hearing and speech development, middle ear function, subjective~     complaints and complications will be assessed. User satisfaction and other aspects related~     to the quality of control will also be assessed.~      If the study shows that follow-ups after surgery with VTs can be done on the level of~     primary care without loss of care quality, specialist health care services will be spared~     and cost-effectiveness for the overall healthcare system will improve.~   "
17227|NCT02831972|"~     An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses~     of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects.~     Period 1 consists of a single oral dose of AG-120 will be administered at Hour 0 followed by~     PK sampling for 504 hours (21 days). In Period 2, multiple oral doses of itraconazole will~     be administered once daily (QD) for 18 consecutive days with a single oral dose of AG-120~     coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21~     days) following AG-120 dosing on Day 1.~   "
17228|NCT02831959|"~     The study is a prospective, randomized controlled phase III trial, to test the efficacy,~     safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic~     radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to~     supportive treatment alone. The device is an experimental, portable, battery operated device~     for chronic administration of alternating electric fields (termed TTFields or TTF) to the~     region of the malignant tumor, by means of surface, insulated electrode arrays.~   "
17231|NCT02831920|"~     The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic~     biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the~     one hand and underdiagnosis and undergrading of significant PCa on the other.~     multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the~     clinics for biopsy targeting, but the value in biopsy naive patients remains controversial.~     With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised~     with the potential to improve ultrasound imaging for prostate cancer detection and~     localisation significantly. The past years numerous studies have been performed with CEUS,~     all basing their results on subjective judgement of the investigator. To overcome these~     difficulties CEUS quantification techniques have been used with encouraging first results.~     These imaging techniques have been proposed to improve the yield of prostate biopsies and~     possibly replacing systematic biopsies.~      In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy.~     Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS~     lesions, together with standard systematic biopsies in the same patients by separate blinded~     clinicians. The main outcome measure is the per-patient (significant) prostate cancer~     detection rate for each of the biopsy regimens.~   "
17232|NCT02831907|"~     The purpose of this study is to evaluate the possible association between portal vein flow~     pulsatility and acute kidney injury after cardiac surgery. Participants will undergo~     assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound~     before surgery and daily for three days after cardiac surgery.~   "
17233|NCT02831894|"~     Treatment-seeking insomnia sufferers most often present in primary care venues where the~     first and usually only treatment is a prescription for a sedative hypnotic, typically a~     benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients,~     short-term or intermittent use provides satisfactory insomnia relief. However, more than 65%~     of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain~     on these agents for more than five years. Whereas some patients may appreciate partial or~     full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of~     these agents may not represent optimal therapy. A sizable proportion of insomnia patients~     who participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy~     (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment.~     However, it is difficult for most long-term hypnotic users to convert from use of~     medications to a self-management approach. Interventions that combine CBT-I with supervised~     medication tapering (SMT) have shown the greatest promise for achieving this outcome, but~     almost 50% of patients who receive this assistance either fail to discontinue their~     hypnotics or return to them even if they do achieve short-term abstinence. Previous research~     provides only a rudimentary understanding of how to help long-term hypnotic users~     discontinue their sleep aids and successfully manage their insomnia with CBT-I techniques.~      Limitations of existing research include failure to consider how:~        1. the pace of hypnotic withdrawal influences outcomes;~        2. patient characteristics such as belief in the need for sleep medications, and anxiety~          sensitivity moderate outcomes; and~        3. hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes.~      This R34 project will gather key pilot data to address these limitations. Specifically, this~     project will compare the currently recommended tapering pace (25% dose reduction every two~     weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering~     condition to determine the influence of tapering pace on outcomes. The study also will~     examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and~     hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic~     withdrawal symptoms and level of sleep disturbance during withdrawal will be tested as~     mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be~     randomized to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be~     examined to assess their influence on outcomes. Primary outcomes will include drop-out rates~     and hypnotic discontinuation rates observed for each SMT pace. Investigators will tally~     rates of those who achieve hypnotic dose reductions during SMT and those who return to~     hypnotic use by a 3-month follow-up as secondary endpoints. Results will inform a future~     R01-level clinical trial focusing on tapering pace, patient characteristics that moderate~     the effect of tapering pace, and psychophysiological processes that mediate the effect of~     tapering pace. This line of research will inform clinical practice by helping to refine~     guidelines for tapering pace so as to provide more successful, person-centered interventions~   "
17234|NCT02831881|"~     A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in~     Non Emergent High Risk PCI patients.~   "
17235|NCT02831868|"~     To determine the safety, tolerability and efficacy of the HAVAI device as a minimally~     invasive double anchor and suture orthopedic implant fixation device for IMA reduction in~     cases of HV deformities when the IMA is greater than 120 and less than or equal 200.~   "
17236|NCT02831855|"~     This study is designed to evaluate the efficacy and safety of tofacitinib modified release~     formulation (11mg QD) versus tofacitinib modified release formulation plus continued~     methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are~     insufficiently responding to their stable dose of methotrexate treatment.~   "
17237|NCT02831842|"~     This non-interventional study will meta-analyze overall survival outcomes among the~     participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat~     sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with~     bevacizumab containing treatment regimen in routine clinical practice. The study leveraging~     secondary data from existing cohorts in the United Stats of America (USA), Germany,~     Australia, and Denmark.~   "
17238|NCT02831829|"~     The aim of the study is to compare the effect of water-based and land-based exercise~     training, and usual care (no exercise training) in patient with coronary artery disease, on~     exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic~     function, and markers of neurohormonal activity, activated hemostasis and inflammation.~   "
17239|NCT02831816|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP~     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
17240|NCT02831803|"~     This study is designed to test the feasibility of asking older adults with high blood~     pressure to supplement their daily diets with walnuts and extra-virgin olive oil.~   "
17241|NCT02831790|"~     The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of~     a novel education program in combination with usual care, versus usual care alone, on~     preparing parents of children undergoing Fontan surgery for the challenges of the~     postoperative course.~   "
17242|NCT02831777|"~     The goal of the study is to test the capability of the CareTaker monitor to calibrate its~     continuous blood pressure readings independently. Currently the device requires another~     approved blood pressure monitor to provide a starting calibration.~      The new control module enables the CareTaker to perform a pressure sweep of the internal~     pressure in the finger cuff. The resulting data is analyzed using a combination of pulse~     analysis/oscillometry approach.~   "
17243|NCT02831764|"~     This study will compare safety, efficacy, and tolerability of a two drug regimen of~     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two~     nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate~     [TDF]/emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human~     immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received~     antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral~     activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long~     term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148.~     Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC~     FDC. Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels~     and by screening CD4+ (cluster of differentiation 4) cell count.~   "
17244|NCT02831751|"~     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the~     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The~     study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP~     Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria~     and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine~     is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The~     study will also help to define the optimal dose in this population, establish potential~     competitive advantages, and support the design of future studies.~   "
17245|NCT02831738|"~     Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial~     visit after administration of polydextrose (12g) compared to 0 mg placebo.~      Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in~     3 days following treatment administration.~   "
17266|NCT02831465|"~     Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is~     used to assess the ventilatory function during exercise in COPD (Chronic Obstructive~     Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and~     is believed to be due to expiratory flow limitation.~      The present study is intended to assess whether DH can also occur during MVV in normal~     subjects without expiratory flow limitation.~   "
17246|NCT02831725|"~     1. Demographics data;~        2. Nutritional evaluation data;~        3. All biochemical monitoring data during the study period;~        4. All nutritional treatment data will be recorded daily during the study period,~          including actual calorie intake, protein intake, and the proportion of calorie/protein~          administered by EN and/or PN route. The nutritional treatment protocol will be decided~          by the attending physician, the investigator will not intervene.~        5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll~          into the study, and the metabolomics of the samples will be analyzed analysis using a~          combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish~          metabolic profile baseline.~        6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients~          according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take~          one blood sample daily during the whole study period. The plasma sample will be used~          for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be~          used for metabolic dynamic modeling.~        7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal~          fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial~          infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization~   "
17247|NCT02831712|"~     This study aims to investigate a possible effect of iron status on temporary build-up of~     non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.~   "
17248|NCT02831699|"~     This study will evaluate subjects with fever and/or rash to determine the percentage of~     those infected by the Zika, Chikungunya, or Dengue virus. The study will also compare the~     clinical signs, symptoms, and lab abnormalities related to each virus, to better specify~     each virus's characteristics.~   "
17249|NCT02831686|"~     The purpose of this study is to test the safety of a combination of study drugs called~     selinexor (KPT-330) and ixazomib (MLN9708) with a low dose of dexamethasone. This study~     tests different doses of the study drug, selinexor to see which dose is safer in people.~     Depending on which group (dose level) you are in, the dose of selinexor will vary, but the~     ixazomib and dexamethasone doses will be the same among the groups.~   "
17250|NCT02831673|"~     This study will compare safety, efficacy, and tolerability of a two drug regimen of~     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two~     nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose~     combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected~     adult subjects that have not previously received antiretroviral therapy. The study is~     designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that~     of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability~     and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised~     1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV~     1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation~     4) cell count.~   "
17251|NCT02831660|"~     The objective is to collect the safety data of idarucizumab for patients treated with~     dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of~     uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are~     required.~   "
17252|NCT02831647|"~     Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE~   "
17253|NCT02831634|"~     Feasibility study for a method allowing identification of tumor mutated epitopes in patients~     with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for~     these tumor neo-antigens in their lymph nodes~   "
17254|NCT02831621|"~     Excess ectopic fat deposition is associated with development of cardiovascular and metabolic~     diseases. This study investigates how lifestyle interventions can have an effect on~     different sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover,~     the clinical and economic value of exercise to supplement a hypocaloric diet is~     investigated.~      Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women~     during consultations. Also, recruitment posters will be used in the University Hospital of~     Antwerp and the University of Antwerp. Potential participants meeting all a priori set~     inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric~     diet group (usual care) or a group of hypocaloric diet combined with physical fitness~     training. Both groups will undergo an intake procedure in which personal goals are set and~     barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured~     by imaging techniques after three and six months of intervention. A post-intervention~     follow-up period of six months is planned. Based on the known relationship between ectopic~     fat and cardiovascular outcomes, the short term study results will then be extrapolated to~     an estimation of the reduction of cardiovascular events.~      The following clinical outcomes will be presented: change in ectopic fat in the abdomen~     (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular~     lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity)~     intervention. The impact of supervised exercise in addition to diet will be expressed in~     projected healthcare costs and quality adjusted life years.~   "
17263|NCT02831504|"~     PhenoDM1 will use patient reported outcomes to assess levels of pain, fatigue and quality of~     life in this cohort. Clinical and functional outcomes will look at muscle wasting and levels~     of myotonia. DNA, RNA, serum and CSF samples will be taken from all patients so that~     additional genetic and molecular biomarker analysis can be carried out. A subset of patients~     will undergo detailed sleep studies along with skeletal muscle MRI of the lower limbs. This~     study will complement the work of other groups currently looking at myotonic dystrophy type~     1 using the same outcomes and measures where possible.~   "
17264|NCT02831491|"~     The main purpose of this study is to evaluate the safety of the study drug ramucirumab in~     combination with weekly docetaxel in participants with stage IV non-small cell lung cancer~     (NSCLC) following disease progression after prior platinum-based chemotherapy.~   "
17265|NCT02831478|"~     To assess the safety of a sunscreen product under supervised outdoor-use conditions with the~     target consumer~   "
17267|NCT02831452|"~     The aim of this study is to determine if there is a correlation between digital palpation,~     perineometry and dynamometry as PFM function evaluation methods in nulliparous without~     pelvic floor dysfunction.~   "
17255|NCT02831608|"~     Background. For more than a century a causal link between influenza and cardiovascular~     disease has been suspected. It is conceivable that influenza may precipitate plaque rupture,~     increase cytokines with central roles in plaque destabilization and trigger the coagulation~     cascade. Accordingly, registry studies, case control studies and a few small randomized~     trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute~     myocardial infarction (AMI) is increased following respiratory infection and that the risk~     of stroke and AMI in patients with established cardiovascular disease seem to be reduced~     following influenza vaccination. In May 2015 a Cochrane review concluded that influenza~     vaccination may reduce cardiovascular mortality and cardiovascular events but bias and~     inconsistent results in prior studies require higher-quality evidence to confirm these~     findings. High costs and little commercial interest in conducting a randomized trial on~     influenza vaccine in cardiovascular disease stand in the way.~      Objective. The objective is to document whether influenza vaccination protects against~     cardiovascular events and death after an AMI.~      Methods. Population: 4400 patients with ST-elevation (STEMI) or non-ST elevation myocardial~     infarction (NSTEMI) are randomized 1:1 in a blinded fashion using an RRCT design and~     followed up via registries and two telephone calls. Intervention: Influenza vaccination.~     Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial~     infarction and stent thrombosis till 1 year in patients with STEMI/NSTEMI undergoing~     coronary angiography/PCI. Patients will be included in the study in all of Sweden's 8~     university hospitals, 3 university hospitals in Denmark, 1 in Finland, 1 in Iceland and in 1~     specialized heart center in Norway. Secondary endpoints are time to all-cause death, time to~     stent thrombosis, time to revascularization, time to myocardial infarction, time to stroke~     or time to rehospitalization for heart failure till 1 year, 2 years, 3 years and 5 years.~     Furthermore, an extensive health-economic analysis will be conducted. The trial has been~     approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency~     (EudraCTnr -2014-001354-42) in Sweden.~      Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza~     vaccination may become an important novel in-hospital therapy for patients with~     cardiovascular disease and the accompanying direct and indirect societal gains will be~     profound. IAMI will be the first placebo-controlled RRCT conducted.~   "
17256|NCT02831595|"~     Modern knee implants combine several types of metal and therefore potentially expose~     patients to different metal ions.~      Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion~     process and the metallic ions release towards the surrounding biologic environment, thus,~     making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.~      The aim of the study is to verify that the postoperative plasma metal concentrations at 1~     year are not different than preoperative values.~   "
17257|NCT02831582|"~     This clinical trial studies the use of omega-3 fatty acid supplementation in preventing~     aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3~     supplementation may help relieve moderate to severe bone pain and improve joint symptoms~     caused by aromatase inhibitor-induced arthralgias.~   "
17258|NCT02831569|"~     This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy~     of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients~     with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome~     associated with muscle strain. More than 90 patients will be screened to enroll~     approximately 80 patients in the trial.~      After giving written informed consent, patients will be enrolled in the trial. Patients who~     are considered eligible for the trial by the Investigator after consent and complete the~     trial procedures and assessments at Visit 1 will receive the trial medication and enter the~     open-label treatment period of 2 weeks. Patients who complete the open-label treatment~     period will enter the follow-up period of 1 week and complete the trial after confirmation~     at the last visit (or phone interview).~   "
17259|NCT02831556|"~     Summary~        1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid~          acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images.~          The study will use a newly developed acquisition method and post-processing technique~          to create three dimensional image models of the abdomen and/or pelvis.~        2. Study activities and population group. The study population will be a convenience~          sample of patients of any age presenting to the Emergency Department with complaints~          necessitating a clinical abdominal and/or pelvic imaging. The study intervention~          includes acquisition of research ultrasound images, which will not be used for clinical~          care, and comparison of these images with clinically obtained images. Other clinical~          data such as surgical and pathology reports will also be reviewed. 3.Data analysis and~          risk/safety issues. This is a pilot study intended to determine feasibility and to~          refine image reconstruction algorithms. Research images will be compared to clinical~          images. Comparison of research images with final diagnosis will also occur. The~          research intervention, an ultrasound exam, has no known safety risks. The only risk to~          subjects is loss of confidentiality.~      This study is observational, not interventional, because the experimental ultrasound will be~     performed in all subjects and will not be used in the clinical care of patients~     (consequently, will not have the opportunity to affect clinical outcomes). Experimental~     images will be reviewed after completion of clinical care and will not be provided to the~     clinicians caring for the subjects. The investigators are not measuring the effect of the~     ultrasound examination on the subjects' outcomes.~   "
17260|NCT02831543|"~     A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical~     trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in~     functional dyspepsia patients.~   "
17261|NCT02831530|"~     Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous~     cancers including breast cancer. The objective of this study is to identify if a new~     preoperative oral treatment, abemaciclib directed against the CDK / 6 compared to no~     treatment, inhibits tumor growth or induced senescence (aging) tumor.~      This early study is offered to women who are going to be operated on for breast cancer with~     expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive~     one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other~     patients do not receive treatment. The decision to receive or no treatment will be done by a~     random computer draw.~      The drug's effectiveness will be evaluated primarily on the biological parameters of the~     tumor itself when comparing surgery to before treatment. These results biomarkers will allow~     us to better know how this treatment and eventually will be used in future to identify~     patients for whom treatment with abemaciclib more efficiency.~      Patients treated in the protocol will then receive treatment entirely conventional in their~     breast cancer within the parameters of their tumors: their participation is very limited in~     time.~   "
17262|NCT02831517|"~     The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of~     BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants;~     and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy~     Japanese participants. The secondary objective of this study is to assess the safety and~     tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian~     participants) and as repeated oral doses (Japanese participants).~   "
17269|NCT02831426|"~     The rationale for present trial conception and design moves forward from the assumption that~     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is~     feasible, safe and giving rewarding results when compared to the standard retro-pectoral~     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes~     between a biological and a synthetic material when placed as a support under the mastectomy~     skin flaps, both in terms of immediate complications and of long-term results.~   "
17270|NCT02831413|"~     This project will test the effectiveness of offering healthy marriage and relation education~     for youth as part of the regular school curriculum and examine whether providing enhanced~     training and support for facilitators shows promise for enhancing the effects on high school~     students. The evaluation will examine a range of students' relationship outcomes, including~     their attitudes toward relationships, their knowledge of healthy relationships, their~     communication skills, and the characteristics of their current relationship.~   "
17271|NCT02831400|"~     The purpose of this study is to detect changes in circulatory I-FABP values (50% increase)~     in elderly volunteers following the combination of moderate physical activity and a standard~     meal.~   "
17272|NCT02831387|"~     The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry~     Eye Symptoms.~   "
17273|NCT02831374|"~     Purpose: This prospective randomized comparative clinical study was conducted to assess the~     effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration~     potential on lower third molar extraction sockets.~      Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a~     lower impacted third molar and who fulfilled the inclusion criteria were recruited. The~     patients were categorized into two groups, Group A and Group B. For each group 25 patients~     were randomly allocated. The predictor variable in Group A was the application of PRP Gel~     whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing~     and osseous regeneration was assessed using standard methods. These outcome variables were~     assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th,~     10th, and 16th postoperative week for assessment of bone healing. The data were recorded and~     tabulated.~   "
17274|NCT02831361|"~     The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg~     orally administered once daily for 24 weeks compared with placebo in patients with type 2~     diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in~     combination with metformin stably for 8 weeks.~   "
17275|NCT02831348|"~     This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children~     with inflammatory and non-inflammatory conditions.~   "
17276|NCT02831335|"~     The purpose of the study is to investigate the associations of the age-related changes in~     the brain, kidneys and cognitive performance in healthy adults by utilizing multiple~     anatomic and functional MRI methods along with a battery of cognitive tests.~   "
17277|NCT02831322|"~     Several approaches have been proposed to reduce the risk of RAO, including anticoagulation,~     immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler~     ultrasound examination showed that interrupted blood flow in RA tend to occur in the~     proximal end rather than distal part of the artery,which was ignored by a majority of~     interventional cardiologists. Different insights into occlusion location may lead to~     different options of sheath materials, models, catheters and puncture access. Thus, the~     investigators designed this present study to explore the reason of radial artery endothelial~     dysfuction and damage and occlusion location by ﬂow-mediated dilation (FMD) to determine the~     suitable method to reduce occlusion risk during TRI.~   "
17278|NCT02831309|"~     ACS examined the potential influence of intermittent physical activity breaks of various~     intensities (control, light, moderate, vigorous) on measures of immediate mental~     performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We~     build upon previous work to hypothesize that higher-intensity intermittent physical activity~     breaks throughout an 8-hour day will improve immediate mental performance, mood, and~     post-exercise physical activity levels, while reducing hunger and post-exercise food intake.~   "
17279|NCT02831296|"~     SPOT SMA is a prospective NIH-supported clinical study targeting pre-symptomatic or recently~     diagnosed infants and children with Spinal Muscular Atrophy (SMA) types 1, 2, or 3 and their~     healthy control siblings less than 36 months of age at the time of study enrollment. The~     main objective of the study is to prospectively collect longitudinal clinical outcomes and~     provide counseling and education to parents of newly diagnosed children. The study will~     assess the impact of current standard of care management paradigms and interventions on~     health outcomes in newly diagnosed SMA infants and children with type 1, 2 or 3 and age~     appropriate controls. There is no investigational drug and no specific intervention in this~     study. Rather, the investigators will document outcomes related to current therapies~     provided to participating subjects, and will educate participants about possible clinical~     trial opportunities.~   "
17280|NCT02831283|"~     This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A~     type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal~     accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in~     the brain. These are thought to be involved in Alzheimer's disease. The investigators will~     also perform brain MRI and do tests to measure the participants' memory and thinking.~   "
17292|NCT02830984|"~     Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important~     techniques in the treatment of bile duct stones. A number of studies have been conducted~     using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In~     those studies, the authors suggested that EST plus LBD might lower the risk of post~     procedure pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than~     the pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary~     drainage catheter can prevent PEP. However, it is still unclear that nasobiliary drainage~     after endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative~     pancreatitis in treating of large bile duct stones.The investigators therefore designed a~     prospective randomized trial to determine whether nasobiliary drainage prevent PEP after~     endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.~   "
17281|NCT02831270|"~     Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's~     outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential~     procedure for cardiac surgery, dilutes patient's blood components, possible impact of~     applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well~     investigated.~      In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years,~     n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients~     (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage~     and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be~     started at 30 min after anesthesia induction and before CPB application for surgery. In both~     groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless~     priming solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr~     will be determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the~     second ANH of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5),~     immediately and 1 hour after the weaning from CPB (T6, T7) and at the end of surgery (T8).~     S-Cr will be determined by using a point-of-care test device (StatSensor™ Creatinine, Nova~     Biomedical, USA).~   "
17282|NCT02831257|"~     The goal of this clinical research study is to learn if the study drug AZD2014 can shrink~     growing or symptomatic meningiomas.~   "
17283|NCT02831101|"~     We compared BIS values during propofol stepwise induction with or without concomitant~     sufentanil in patients ≥ 65 years .~   "
17284|NCT02831088|"~     Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA~     receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute~     ischemic stroke patients receiving endovascular treatment to remove clot within 8 hours~     following stroke onset. Neu2000KWL will be administered before endovascular treatment.~   "
17285|NCT02831075|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic~     foot.This study intends to establish an optimal clinical research program, and attempts to~     break the technical bottleneck in the stem cell therapy for treating diabetes related~     vascular complications.~   "
17286|NCT02831062|"~     This study will evaluate patients who have an episode of moderate to severe acute kidney~     injury (AKI) and are followed in a focused post-AKI clinic. After patients present signs of~     kidney recovery and before hospital discharge, patients who give consent will be enrolled in~     the study. At the first post-AKI clinic visit, patients will be randomly allocated to follow~     a normal (ad-lib) or a low protein diet (LPD) for 3 months. Patients allocated to a LPD will~     receive a drug called Ketosteril. This drug allows the intake of essential amino acids while~     minimizing the amino-nitrogen intake, what in excess, can be bad for the recovered kidney.~     The investigators will evaluate the nutritional parameters and the kidney recovery of all~     patients and compare these parameters in those two groups.~   "
17287|NCT02831049|"~     Background:~      Sights, sounds, and smells can be associated with alcohol and tempt people to drink. The~     connection between encountering cues and wanting to drink might be reduced by behavioral~     techniques, like giving the cues at certain times, in certain circumstances.~      Objective:~      To see if visual imagery and behavioral techniques can reduce alcohol craving and drinking.~      Eligibility:~      Healthy people ages 21 65 who are mildly concerned about their drinking and have had these~     habits in the past 3 months:~      Women: More than 3 drinks any single day and more than 7 drinks per week~      Men: More than 4 drinks any single day and more than 14 drinks per week~      Design:~      Participants will be screened with medical history, physical exam, blood tests, alcohol~     breath tests, hepatitis tests, and alcohol and drug use questionnaires.~      Participants will get a smartphone to carry throughout the study. They will use it to report~     on their drinking, moods, and activities daily. The phone s GPS will record their locations~     throughout each day.~      There will be 6 study visits over 4 weeks. Visits will last up to 4 hours, but the final~     visit lasts up to 7 hours. Visits include the following:~      Not drinking alcohol or using illicit or over-the-counter drugs at least 24 hours before~     each~      visit~      Providing urine and breath samples.~      Exposure to various cues. Participants reactions will be monitored by measuring heart rate,~      blood pressure, and skin temperature.~      Drinking alcohol or soft drinks. For visits with alcohol, transportation to and from the~      visit will be provided.~      About a month after the last visit, participants will be called to ask about their drinking~     and cravings.~   "
17288|NCT02831036|"~     20 healthy man, 10 in trial group and 10 in control group (randomly divided) will~     participate in the experiment on order to evaluate if improvement in physical fitness~     influences spatial learning in humans.~   "
17289|NCT02831023|"~     The purpose of this study is to determine the most efficacious transmission blocking drug~     regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be~     the proportion of mosquitoes infected pre and post-treatment, assessed through membrane~     feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed.~     Primary endpoint will be a within group comparison between the mean of the pretreatment~     infectivity (Day 0) and infectivity at 7 days post first dose.~   "
17290|NCT02831010|"~     The purpose of this study is to explore the perinatal risk factors of encephalopathy of~     prematurity and the morbidity of the following neurodevelopmental impairments in preterm~     infants with gestational age <32 weeks in China.~   "
17291|NCT02830997|"~     In total knee replacement operations, the surgeon uses techniques and instruments to guide~     the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are~     placed into the correct position. There are many techniques a surgeon can use to achieve~     accuracy in the operation. This study will compare the Principal Investigator's present~     precision-guided technique and instrumentation methods with a newly developed technique that~     uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to~     learn whether the use of the different guidance systems results in differences of accuracy~     of the placement of the prosthesis; 2.) to compare the length of time it takes an~     experienced joint replacement specialist to complete the operation using the different~     guidance systems; 3.) to learn whether there are advantages of either system in terms of the~     function and recovery of patients over the first year after surgery; and, 4.) to provide the~     manufacturer of the stereotactic guidance system with feedback on the technical ease of use~     and workflow ease of the system which may be used for training and education purposes and/or~     for planning further refinements to the system. The study will enroll up to 150 patients~     from Athens Orthopedic Clinic over 2 to 3 years.~   "
17293|NCT02830971|"~     The nurses were learned the theoretical and practical skills previously during their~     studentship period. The procedures will be the first time the nurses wanted to perform in~     ICU. All clinical situations including patient, procedure, and shift will be similar for~     nurses. The end point will be reaching to the 95 score of learning curve. The reason for~     selection less than 5 percent variation was the flattening of learning curve (the plateau~     section).~   "
17294|NCT02830958|"~     The hip is a commonly performed operation. It is a prosthetic joint replacement surgery~     whose effectiveness depends on the quality of architectural and mechanical reconstruction of~     the artificial hip, integrity and balance of the periarticular musculature. To achieve this~     dual purpose, two elements are essential: access to the hip that best meets the musculature~     and is able to restore the balance, and adequate prosthesis.~      Despite the move towards a surgery less invasive hip replacement is a procedure that causes~     tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in~     about 30% of cases.~      Several studies have shown that there are risk factors for chronic post-surgical pain. They~     are both related to patients but also to surgery.~      Puolakka in his study correlates chronic pain and post-surgical acute pain following surgery~     in surgical patients with total knee arthroplasty. Indeed, post-operative acute severe pain~     multiplies by 10 the risk of developing chronic pain.~      It is thus advantageous to reduce the postoperative pain, localized mainly in the~     trochanteric region, to decrease the risk of developing chronic post surgical pain. Now~     medical comunity know that the post-operative bruising and tissue damage are partly~     responsible for these pains.~      The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the~     1970s It is water resistant and retains its properties up to 5 days.~      It has the characteristic to cause elevation of the epidermis and thereby reduce the~     pressure on the mechanoreceptors below the dermis. This would have the effect of reducing~     nociceptive stimuli.~      Its designers also claim it would have a beneficial effect on the lymphatic and venous~     circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the~     pressure in the dermis and promoting lymphatic drainage through its mechanical action during~     movement.~      The lymphatic system is responsible for the capture of waste from venous blood (catabolites,~     plasma proteins) and thus can promote the absorption of edema.~      In his study, Donec highlights a significant decrease in pain and a higher absorption of~     postoperative edema in the Kinésiotape® group than in the control group in surgical patients~     with total knee arthroplasty .~      The Curetape® band is used in the orthopedic surgery department since 2010 in current care.~      Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients~     with a total hip replacement.~   "
17295|NCT02830945|"~     American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with~     higher prevalence and incidence, younger age at onset, and poorer survival than other racial~     and ethnic groups. With a stroke incidence more than twice that of the general U.S.~     population, stroke in AI's is a public health problem of staggering scope. AI's also have~     disproportionate burdens of many risk factors for stroke, including hypertension, smoking,~     obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention~     have included AI's. The investigators at WSU, and community partners, have designed the~     Family Intervention in the Spirit of Motivational Interviewing (FITSMI), a program~     delivered at the household level to encourage lifestyle changes that transform the home~     environment and reduce stroke risk for all residents. FITSMI uses a talking circle format~     in which facilitators guide participants to identify goals for change and create a tailored~     plan for sustainable implementation that may target smoking, exercise, diet, or medication~     adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text~     messaging used to boost long-term adherence. In a group-randomized trial design, the~     investigators will recruit 360 households where Strong Heart Family Study members aged 45~     and older reside. The investigators will assign half to FITSMI and half to a control~     condition that receives educational brochures.~   "
17296|NCT02830932|"~     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the~     Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F~     Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to~     Healthy Volunteers~   "
17297|NCT02830919|"~     This phase III clinical study will be conducted in Brazilian research sites. It will be~     included in the study 314 participants diagnosed with primary knee OA according to the~     classification criteria of the ACR. After a washout period, the participants will be~     randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine~     origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate +~     chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment~     period of the study will be of 24 weeks. Each participant will perform seven visits to the~     research site. The main evaluations will be the improve of pain in the target knee by~     questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and~     quality of life by SF-12 questionnaire.~   "
17298|NCT02830906|"~     We would like to know the prophylactic anti-emetic effect of ramosetron compare to~     ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and~     intrathecal morphine .~   "
17299|NCT02830893|"~     This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever~     Actuated Resonance Assistance. LARA facilitates patients in performing a high amount of~     practice using their moderate to severely impaired upper extremity after stroke.~      Investigators will recruit 44 subjects with subacute strokes to participate in the study~     through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants~     will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA~     therapy group will use LARA to propel themselves to therapy appointments in the unit and to~     play video games with the affected upper extremity for 30 mins / day. The standard therapy~     group will use a standard wheelchair to propel themselves using their unaffected upper and~     lower extremities. They will be asked to perform a matched duration of standard arm~     exercises for 30 mins/ day. This program of standard arm exercises was developed by an OT at~     the Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported~     exercises.~      This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge~     from the acute rehabilitation unit if sooner, and a 3-month follow up.~   "
17300|NCT02830880|"~     The purpose of this study is to assess if using~     anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan~     will be useful in determining if participants are responding to chemotherapy treatment.~      Investigators will enroll participants whose cancer has been treated with hormone therapy~     and now the cancer is not responding to the treatment (Castration -resistant), and so~     therefore will be started on chemotherapy. Investigators will enroll thirty (30)~     participants in this study.~   "
17301|NCT02830867|"~     The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive~     inheritance, is a rare disease (70 patients described in the world). The outcome of these~     patients and potential complications of this disease are not, to date, yet all known and~     described.~   "
17302|NCT02830854|"~     A variety of non-pharmacological interventions have been used in the management of~     Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic~     modality has demonstrated conclusive positive results in terms of effectiveness. Although it~     is still unknown what triggers AD, recent studies have shown that AD is associated with~     brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental~     molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable~     mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and~     perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis~     to be evaluated in this project is that administration of H2 will positively affect~     patient-reported outcomes and clinical biomarkers in men and women suffering from AD.~   "
17303|NCT02830841|"~     Remote ischemic preconditioning(RIPC) is emerging as an promising therapeutic paradigm to~     combat the detrimental impact of ischemic and reperfusion injury. In liver transplantation,~     ischemic and reperfusion injury severely impacts the post-surgery liver function and patient~     outcome. This prospective, double blind, randomized clinical trial is aimed to test the~     protective effect of RIPC against hepatic ischemic and reperfusion injury in pediatric liver~     transplantation.~   "
17304|NCT02830828|"~     INTRODUCTION Carpal tunnel syndrome (CTS) is a common condition that results in impaired~     hand function. In cases of CTS the pinch grip force between the thumb and index finger~     becomes unnecessarily high to prevent objects from slipping when they are picked up.~      HYPOTHESES The proposed study will investigate the following hypotheses regarding CTS.~      As an object is picked up, the investigators suspect there will be several points at which~     grip force will be different between patients with different severities of CTS, i.e. grip~     may deteriorate as CTS gets worse.~      The investigators also suspect grip force will be affected depending on the weight of the~     object, i.e. patients with CTS may struggle with objects of a certain weight.~      Patients with CTS sweat less, and this may affect their grip. The investigators suspect that~     pinch grip in CTS patients is disproportionately altered by the frictional properties of the~     object and by the moistness of the skin.~      The investigators suspect patients with CTS will be less able to adapt to sudden changes in~     an object's weight.~      The investigators wish to examine how the above are affected after surgical treatment of~     CTS.~      METHODS The investigators will include patients with symptomatic, idiopathic CTS, aged~     between 18 and 80 years. The investigators' centre will recruit CTS patients who will attend~     their National Health Service (NHS) outpatient appointment followed by nerve conduction~     studies. An equal number of healthy participants will be recruited for comparison purposes.~      At the aforementioned appointment, patients will undertake a pinch grip force test using a~     device that will test the above points.~      Patients will have normal care under their surgeon, which may include an operation for~     treatment of CTS. Therefore some patients will be invited back to have grip tests again~     after their operation. No aspect of the study will prevent a patient from receiving their~     normal National Health Service (NHS) care.~   "
17305|NCT02830815|"~     This will be a prospective, blinded, cross-over study to compare the effects of two~     anesthetic techniques on the interpretability of auditory brainstem response testing in~     children.~   "
17306|NCT02830802|"~     The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung~     Salbei) whether it is less or equal effective in alleviating inflammatory signs of~     intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients~     dependent on ADL.~      Randomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo~     mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional~     to habitual oral hygiene protocol.~      The main outcome parameter will be Sulcus Bleeding Index SBI.~   "
17307|NCT02830789|"~     This study investigates whether calcium citrate or calcium carbonate are the optimal~     supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass~     operation.~      Half of the participants will be randomized to receive calcium citrate, while the other half~     will receive calcium carbonate. The study will be double blinded.~   "
17308|NCT02830776|"~     Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are~     most pronounced when used directly onto the cornea for the treatment of glaucoma. Changes~     are primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in~     deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of~     topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement,~     may provide a metered effect on the periocular tissues and allow for a topical approach to~     periocular rejuvenation.~      This is a proof of concept study which aims to enroll a series of patients with mild to~     severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid~     margin, and evaluate for cosmetic improvement of the periocular area.~   "
17309|NCT02830763|"~     This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty~     acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit~     cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M)~     associated with adipose triglyceride lipase (ATGL) genetic defects.~   "
17310|NCT02830750|"~     Prospective data collection of patients undergoing Atrial Fibrillation Ablation.~   "
17311|NCT02830737|"~     Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma~     (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an~     electrode needle directly into the tumor. This clearly violates no-touch technique based on~     the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to~     30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch~     RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer~     cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA~     treatment reduce the recurrence rate after operation in comparison with the traditional RFA~     treatment. This research project aims at using the prospective randomized comparative method~     to compare the short-term and the long-term curative effects between no-touch RFA and~     traditional RFA treatments for small hepatic carcinoma.~   "
17319|NCT02830633|"~     The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved~     total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether~     LNTME is more effective for protection of pelvic autonomic nerve function from surgical~     impairing when comparing to open TME.~   "
17360|NCT02830074|"~     Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal~     cord injuries and disorders (SCI/D). The investigators' aim is to test a program that~     addresses challenges and barriers to positive airway pressure (PAP) treatment of SDB among~     patients with SCI/D. The investigators anticipate that patients who receive this program~     will have higher rates of PAP use and will demonstrate improvements in sleep quality,~     general functioning, respiratory functioning and quality of life from baseline to 6 months~     follow up compared to individuals who receive a control program. This work addresses~     critical healthcare needs for patients with SCI/D and may lead to improved health and~     quality of life for these patients.~   "
17312|NCT02830724|"~     Background:~      In a new cancer therapy, researchers take a person s blood, select a certain white blood~     cell to grow in the lab, and then change the genes of these cells using a virus. The cells~     are then given back to the person. This is called gene transfer. For this study, researchers~     will modify the person s white blood cells with anti-CD70.~      Objectives:~      To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain~     the treatment is safe.~      Eligibility:~      Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.~      Design:~      Participants will be screened with medical history, physical exam, scans, and other tests.~     They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is~     removed through a needle in the arm. A machine separates the white blood cells. The rest of~     the blood is returned through a needle in the other arm.~      Eligible participants will have an intravenous catheter placed in their upper chest. Over~     several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in~     the hospital.~      Participants will take an antibiotic for 6 months after treatment. They will repeat~     leukapheresis.~      Participants will visit the clinic every 1-3 months for the first year after treatment,~     every 6 months for the second year, and then as determined by their physician. Follow-up~     visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies,~     and a physical exam.~      Throughout the study, blood will be taken and participants will have many tests to determine~     the size and extent of their tumor and the treatment s impact.~   "
17313|NCT02830711|"~     The mood was influenced by many factors in children. Sport, such as high-altitude mountain~     trek activity was thought benefit for human's mood and health. The expedition therapy was~     more and more popular in many schools recently. However, as the investigators best~     knowledge, there was no article discuss the relation between the mood and high-altitude~     mountain trek activity such as benefit influence in children. So, the investigators conduct~     the study.~      Method: Demographic data will be recorded. The Professor Yeh's mood questionnaires were used~     to record the mood status of before and after the 3 days high-altitude mountain trek~     activity.~      Statistical analyses: Participants rated their emotional states (happiness, sadness,~     anticipation, and anger) on a Likert scale. Each variable will be presented as descriptive~     statistics. Student t test or other suitable statistical method(s) will be used to determine~     the correction among the variables with scores of mood status. The paired t test or other~     suitable statistical method(s) will be used to determine the correction among the scores of~     mood status before and after the mountain activity. A difference was considered~     statistically significant if the p value were less than 0.05. All statistical analyses will~     be performed using SPPS statistical software for Windows, version 14 or more updated~     version.~   "
17314|NCT02830698|"~     The irritable bowel syndrome (IBS) is a very common disease in the pediatric population,~     where classical medical treatment does not always prove effective. This clinical entity has~     an impact on the individual physiological balance particularly on the autonomic regulation.~     Studies concerning adults with irritable bowel syndrome, showed significant changes in heart~     rate variability indices (HRV: heart rate variability).~      The study of time and frequency domain analysis of HRV allows noninvasive and reproducible~     assessment of the cardiac sympathetic and parasympathetic tone.~      The investigators hypothesize that the sympathovagal balance could be altered in children in~     case of prolonged nociceptive stress as the investigators find it in IBS. In recent years,~     the control of pediatric pain experienced considerable growth through hypnosis techniques~     and several studies have shown analgesic efficacy with a beneficial effect in terms of~     quality of life in children.~      Our study aims to assess the impact of the hypno-analgesia treatment of IBS on sympathovagal~     balance. The investigators propose to realize in 7 to 18 years old children with IBS a~     single center prospective study to highlight after a standardized hypnosis program, changes~     in the time and frequency domain indices of heart rate variability and clinical or quality~     of life parameters. The primary endpoint will be the high frequency HF indice. Secondary~     endpoints will be the other indices of HRV (Ptot, VLF, LF, ratio LF / HF, SDNN, SDANN,~     pNN50, RMSSD), the Quality of Life Questionnaire values (PedsQL ™ 4.0) a pain scale and the~     composite score of Francis.~   "
17315|NCT02830685|"~     The rationale for present trial conception and design moves forward from the assumption that~     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is~     feasible, safe and giving rewarding results when compared to the standard retro-pectoral~     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes~     between a biological and a synthetic material when placed as a support under the mastectomy~     skin flaps, both in terms of immediate complications and of long-term results.~   "
17316|NCT02830672|"~     In this randomized, prospective clinical trial, patients with trigger finger or trigger~     thumb, will be treated with two different methods; ultrasound-guided release of the first~     annular pulley or open surgical release of A1 pulley. Results will be compared regarding~     functional, clinical and cosmetic outcome.~   "
17317|NCT02830659|"~     The purpose of this study is to determine the outcome of cochlear implant including post~     operative hearing ability, developing of language, complication from cochlear implant,~     quality of life, and success factor of cochlear implant.~   "
17318|NCT02830646|"~     Obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal~     replacement. Bariatric surgery is a treatment for severe or morbid obesity whose renal~     benefit is currently unknown. The glomerular filtration rate (GFR) is the best parameter to~     define the kidney function. It can be estimated using formulas by assaying endogenous~     markers (creatinine, cystatin C) or measured with an exogenous tracer glomerular filtration~     (51 Cr-EDTA).~      Bariatric surgery alters the production of endogenous markers and the extracellular volume~     (VEC) with 2 important consequences on the assessment of GFR: the formula to estimate GFR is~     not possible to compare renal function before and after surgery because of the variation in~     production of endogenous glomerular filtration markers in the same subject; decreasing VEC~     predicted decreased GFR after surgery, since these parameters are in part proportional to~     each other.~      Our working hypothesis is that bariatric surgery protects the kidneys of patients with~     chronic kidney disease. To demonstrate this, investigators propose to compare the ratio DFG~     / VEC before and after gastric bypass.~      Goals The main objective is to measure the effect of gastric bypass on the report DFG / VEC.~     Secondary objectives are to assess the effect of gastric bypass on the albumin / urine~     creatinine and evaluate the performance of the main GFR estimating formulas in people with~     severe or morbid obesity.~   "
17320|NCT02830620|"~     The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity~     which compromises the forecast of these patients. Several cytokines pro-inflammatory as~     interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the~     man and the animal. Besides, it is now established that different neuronal populations,~     localized in the hypothalamus, are nerve centers of the control of the appetite and the~     energy homéostasie. However, there is not enough evidence of a direct action of cytokines on~     these neurones, suggesting the participation of intermediate molecules as chimiokines,~     inflammatory molecules produced in reaction to an immunological stress by gliales cells and~     acting directly on the surrounding neurones. The implication of chimiokines in the syndrome~     of anorexia-cachexie associated with the cancer thus seems very likely Among these,~     chimiokines  Monocyte Chemoattractant Proteins 1-3  or MCPs represent obvious candidates~     because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual~     expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial~     by-product, the lipopolysaccharide (LPS).~      The investigators' main objective is to test at the Man's, in situation of cancer of the~     pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the~     syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest~     describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand,~     physical composition on the other hand;; ii) the impact of the other chimiokines,~     particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer,~     iii) the correlation enters their profile of expression plasmatique and the severity of the~     anorexia, the energy metabolism and the physical composition; iv) the same research on the~     other inflammatory factors plasmatiques, of nature different from chimiokines; v) the~     correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and~     inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.~   "
17321|NCT02830607|"~     Low back pain (Lower Back Pain ) is extremely common , affecting more than 80 % of the~     general population in the modern world , one is considered the most common cause of~     disability in people under the age of 45. Lower back pain represents a social problem and~     substantial economies in Western countries , also considered a first cause for orthopedic~     consultation. In recent decades , a number of methods developed for assessing the functional~     status of patients with low back pain , and over twenty -five generic methods available~     today for use in pain clinics , orthopedic clinics and in clinical trials A large part of~     the measures used to monitor the response of patients to treatment of low back pain based on~     self-report questionnaires ,on patients' pain intensity , quality of life measures , and~     functional status In recent years a number of wearable monitoring devices designed to help~     people assess the progress of sports activity , by measuring steps , pulse , and quality of~     sleep , in this study we will use these measures to assess treatment efficacy after steroid~     injection to the epidural space in patients with low back pain . And compare the results to~     those taken from subjective self-report questionnaires .~   "
17322|NCT02830594|"~     This phase II trial studies how well pembrolizumab and palliative radiation therapy works in~     treating patients with esophagus, stomach, or gastroesophageal junction cancer that has~     spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Palliative radiation therapy,~     such as external beam radiation therapy, uses high energy beams to treat symptoms that are~     caused by tumors. Giving pembrolizumab together with palliative radiation therapy may work~     better in treating patients with esophagus, stomach, or gastroesophageal junction cancer~     that has spread to other parts of the body.~   "
17323|NCT02830568|"~     The main objective of this multicentre study is to conduct the evaluation of cost-efficiency~     of various techniques of kidney taking with regard the quality of life of the kidney living~     donors.~      It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery~     pure or  hand-assisted  and cœliosurgery assisted by robot) and to determine their~     respective advantages in quality of life, then their medico-economic consequences in a~     cost-efficiency approach from the point of view of the society.~      The evaluation will concern the donor and the receiver followed three months after the~     taking.~      The open donor nephrectomy will be the technique of reference with which will be compared~     the two others.~   "
17324|NCT02830542|"~     The study will involve administering a single dose of investigational drug or placebo in~     ascending dose cohorts. This study is designed to evaluate the safety and tolerability of~     investigational drug as well as the efficacy of investigational drug versus placebo in~     adults with primary (first episode) Clostridium difficile infection (CDI).~   "
17325|NCT02830529|"~     African Americans with prehypertension have a 35% greater risk of progressing to~     hypertension than whites. Dietary Approaches to Stop Hypertension (DASH) is a gold standard~     intervention for hypertension self-management. However, the barriers to self-management of~     hypertension reported by AAs include stress, including perceived stress related to~     racism/discrimination; perceived lack of control over getting hypertension in the future;~     limited social support; and low motivation to change behaviors. Activating the emotional and~     task areas of the brain are hypothesized to improve self-management behaviors. The purpose~     of this study is to test the effects of a promising new self-management intervention for~     AAs, a Mindfulness Attitude to Deliver the Dietary Approach to Stop Hypertension (MAD DASH)~     that departs from conventional interventions to address prehypertension by combining two~     self-management interventions (Mindfulness and DASH) in a group setting. Teaching~     mindfulness; a form of meditation and the DASH diet to participants is expected to result in~     a reduction in blood pressure as compared to usual care or DASH diet education alone.~   "
17326|NCT02830516|"~     Classically lung elastance and transpulmonary pressure are measured from the difference in~     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure~     divided by the tidal volume. This requires the presence of a esophageal balloon catheter~     which is cumbersome and costly. In this study values obtained as described above are~     compared to values obtained with a new method in which a stepwise increase in positive~     endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume~     which the patient is ventilated with. These measurements are performed in anesthetized~     patients prior to major surgery.~   "
17337|NCT02830373|"~     This study aims to investigating the efficacy and safety of low profile visualized~     intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular~     aneurysms.~   "
17338|NCT02830360|"~     This is a pilot study to determine the feasibility of a larger scale multicenter trial~     comparing first line catheter ablation to antiarrhythmic drug therapy for patients with~     prior MI, an ICD and VT.~   "
17361|NCT02830061|"~     This study looks at the experiences of teenagers and young adults who have been offered~     ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or~     cancer treatment putting them at moderate-to-high risk of premature ovarian failure.~   "
17327|NCT02830503|"~     Project summary~      Rationale~      Many NICU's replace their feeding tubes once a week or more rarely in order to avoid~     disturbing the infants. The researchers discovered that there are high concentrations of~     potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even~     within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to~     the colonization of the gut, and development of dysbiosis might lead to necrotizing~     enterocolitis. The researchers speculate if replacing the resident feeding tube every day~     and thereby decreasing the amount of potentially pathogenic bacteria given to the infants~     via the feeding tube will lead to fewer bacteria present in the upper part of the~     gastrointestinal tract of the infant and hence a reduced competition with probiotic~     colonization.~      Objectives~      The investigators plan to conduct an intervention study in premature infants receiving~     probiotics (< 30 weeks of gestation) where the feeding tube will be replaced every day in~     the intervention group and once a week (standard practice) in the control group. The main~     outcome will be bacterial concentration in the stomach after one week of life.~      Methods~      The study is a prospective, randomized controlled trial in preterm infants. Infants will be~     randomized to the intervention group in which the tube is replaced every day or the control~     group which will follow normal practice in the department. The intervention will last one~     week. The infants will be followed until discharge. The investigators plan to include 11~     infants in each group.~      Primary outcome~      Concentration of bacteria in gastric aspirates on day seven.~   "
17328|NCT02830490|"~     The investigators pretend to calculate values absolute and relative reliability that have~     not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and~     go).~   "
17329|NCT02830477|"~     The primary objective of this study is to investigate weekly prophylaxis dosing regimens~     used in standard clinical practice.~      In addition the study will capture reported bleed rate, pattern of change in KOVALTRY~     prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product~     switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data~     (if performed), KOVALTRY consumption, as well as safety data.~   "
17330|NCT02830464|"~     In this study, prognostically relevant biomarkers for cardiovascular / renal insufficiencies~     will be clinically evaluated, to improve the course of assessment of such disease and to~     gain new insights into the typical course of congestive heart failure. This is a~     prerequisite to allow patients to appropriate treatment as soon as possible.~   "
17331|NCT02830451|"~     Clinical, diagnostic, and therapeutic data as well as information on adverse events and~     HRQOL outcomes specific for patients with metastatic spine tumor(s).~   "
17332|NCT02830438|"~     In this proposal, the aim is to examine shear wave elastography (SWE) measurements in~     diseased native kidneys and correlate them with grades of fibrosis using histological~     samples.~      The overall goals of the proposed study are addressed by the following specific aim.~      Specific aim: To determine whether differences exist in elasticity measurements between~     native kidneys with and without fibrosis.~      Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of~     tissue elasticity and stiffness compared to kidneys with zero fibrosis.~   "
17333|NCT02830425|"~     A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.~      Objectives:~        1. To estimate and describe patterns of multimorbidity and polypharmacy in patients over~          64 admitted for a chronic disease exacerbation.~        2. To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP /~          START (SS) criteria.~        3. To evaluate the relationship between multimorbidity and PPI and adverse medication~          (RAM) preventable reaction.~      The cohort will include 800 patients >64 years admitted in internal medicine and / or~     geriatric department of 5 hospitals of the National Health Service. Application of the SS~     criteria (released in 2015) on admission and at discharge, and collection of demographic and~     clinical variables including comorbidities, baseline chronic medication, geriatric~     syndromes, functional capacity and RAM. Descriptive analysis and bivariate parametric or~     nonparametric tests will be applied to analyze relationship between morbidity, polypharmacy,~     SS criteria and RAM. Intraobserver agreement will be assessed for SS criteria. Multiple~     regression techniques will be applied, where the dependent variable will be the PPI or the~     RAM.~   "
17334|NCT02830412|"~     This project intends to develop and implement an electronic reminder for post-operative~     nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.~      Each patient will have his or her PONV risk classified based on the following risk factors:~     Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of~     procedure > 60 minutes.~      Patients will be randomized to either receive the PONV reminder or not. Those receiving the~     PONV reminder will have the PONV risk assessment and current guideline information for PONV~     prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning~     of the case.~      At the end of the procedure (specific at documentation of emergence), the reminder will~     assess the current status of PONV prophylaxis as per anti-emetic medications administered~     and compare the current status to the recommended status based on published guidelines.~      If the current status is compatible or exceeds the recommended status the reminder will~     silently document compliance.~      If published guidelines suggest additional PONV prophylaxis based on the patients risk~     profile and a comparison with the currently documented status, an electronic reminder will~     appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance~     guideline adherence.~      The reminder will not recommend a specific medication, intervention or therapy.~      It will be completely the decision of the anesthesia provider if and how to modify the PONV~     prophylaxis for the patient.~      Subjects randomized to not receive the electronic display will have it deactivated.~   "
17335|NCT02830399|"~     It's a prospective, multicentric, randomized, controlled study concerning 84 patients with~     treatment-resistant depression (TRD). The aim of the study is to evaluate the augmentation~     of Electroconvulsive therapy (ECT) by repeated Transcranial Magnetic Stimulation (rTMS). The~     primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating~     Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the~     safety and most particularly the cognitive effects of this association.~   "
17336|NCT02830386|"~     This study aims to investigating the efficacy and safety of low profile visualized~     intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular~     aneurysms. The follow-up duration is 1 year.~   "
17339|NCT02830347|"~     The aim of this study is to evaluate the nature of the change in oral and gut bacterial~     resistance profiles after antibiotic therapy for a surgical procedure in two groups. The~     intervention group will receive a course of amoxicillin and analgesics after surgical~     extraction and have bacterial samples taken from saliva, tongue coatings and stool samples~     at four appointments over a period of six months. This will be compared to the control group~     which receive only analgesics after the surgical extraction.~      An examination of the development and sustainability of antibiotic resistance in the oral~     and gut microbiome of healthy cohorts will be followed up for 6 months, after surgical~     extraction of impacted teeth.~      Change in proportion of antibiotic resistant bacterial components will be studied using~     Metagenomic DNA sequencing and quantification of resistant genes .~   "
17340|NCT02830334|"~     Background:~      Doctors and nurses who work in non-mental health settings need ways to know when patients~     are at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an~     emergency department for children. This is a 4-item suicide risk screening tool. We wanted~     to see if this is also a good tool to use in the outpatient setting. Two studies are being~     done to test it at hospitals. This study is for researchers to analyze the data from those~     two studies.~      Objectives:~      To combine and analyze data from two studies to see how well the ASQ can detect suicide risk~     in pediatric outpatient clinics.~      Eligibility:~      No people are enrolled in this study.~      Design:~      Participants in the two non-NIH studies will give consent for their data to be shared.~      The data will be confidential and secure. They will have no personal information attached to~     them.~      Researchers will get the data and analyze them.~   "
17341|NCT02830321|"~     The purpose of this study to explore the association between Hyperemesis Gravidarum in~     pregnant women and Helicobacter pylori infection.~   "
17342|NCT02830308|"~     Background:~      There are many endocrine and metabolic-related conditions. Two well-known disorders include~     diabetes and thyroid disease. Some of these diseases are caused by a change in genes.~     Researchers want to identify the genes involved in these disorders. They hope this will help~     them learn more about these diseases.~      Objectives:~      To learn more about conditions that affect the hormone-secreting glands (endocrine glands)~     in adults. To train doctors to diagnose and treat people with endocrine or metabolic~     conditions.~      Eligibility:~      Adults age 18 years and older with a known or suspected endocrine disorder.~      Relatives ages 18 years and older.~      Doctors will review all requests and available medical records to determine final~     eligibility for the protocol.~      Design:~      Participants will have a medical history and physical exam.~      Most participants will have 1 visit, and may have follow up visits if necessary. They may~     have tests, surgery, or other procedures to help diagnose or treat their condition. These~     could include:~        -  Blood, urine, and saliva tests~        -  Imaging tests. These may include X-ray, ultrasound, or scans.~        -  Sleep study~        -  Medical photographs~        -  Visits with other specialists at NIH~      Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may~     be stored in the freezer for future studies.~      Participants may be asked to participate in genetic testing. They will give a blood or~     saliva sample for this.~   "
17343|NCT02830295|"~     A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia~     patients as compared with a control intervention consisting of treatment as an usual.~     Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary~     end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and~     the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory,~     Beck Depression Inventory and Short Form 36. All assessments will be repeated at post~     treatment, 12 weeks and 24 weeks~   "
17344|NCT02830282|"~     This is a nested multicenter, prospective cohort study within the I-SPY 2 TRIAL for women~     undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing~     definitive surgical resection and have clinical or radiographic evidence of residual tumor~     at the completion of chemotherapy.~   "
17345|NCT02830269|"~     Transcranial Doppler ultasonography is usually used in the evaluation and management of~     patients with cerebrovascular disease. This noninvasive method measures local blood flow~     velocity and direction in the proximal portions of large intracranial arteries. The operator~     requires a short training and experience to perfom. The third ventricle diameter measurement~     by transcranial duplex flow sonography was performed in healthy volunteers . This studies~     show similar results in those obtained with the MRI or Computer Tomography (CT). Currently~     the third ventricle diameter measurements by transcranial Doppler ultrasonography was not~     validated for neuro-intensive care unit patients. The investigators propose to used recent~     ultrasound system to validate the third ventricle diameter measurements in comparaison with~     the standard method (CT).~   "
17346|NCT02830256|"~     Nociception in intensive care unit is frequently evaluated with some tools such as BPS~     (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in~     intubated and brain injured ICU patients. The investigators propose to validate the NCS~     adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and~     the Pupillary response (videopupillometry) to noxious stimulation (common procedure of~     care).~   "
17347|NCT02830243|"~     The purpose of this clinical trial is to compare analgesic effect of sevoflurane and~     desflurane at equal minimum alveolar concentrations using surgical pleth index.~   "
17359|NCT02830087|"~     This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol~     by gaining a better understanding of the relationship between tourniquet pressure and time,~     and intraoperative performance and post-operative outcomes. This study does not seek to~     answer the question of tourniquet vs no tourniquet, but to seek a tourniquet usage that~     would maximize the intraoperative benefits for the surgeon and minimize the negative~     consequences for patient outcomes.~      Specific Aim #1: enroll around 146 primary TKA patients.~      Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in~     relation to intraoperative performance.~      Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative~     pain and complications of short-term, intermediate, and long-term followup.~      Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative~     function of short-term, intermediate, and long-term followup.~   "
17348|NCT02830230|"~     There is a strong causal association between persisting genital tract infection with Human~     Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus)~     cancer.The robust study from India have shown that single round of HPV DNA screening test to~     significantly reduce the cervical cancer mortality. The above findings are very encouraging~     since it demonstrates that a simple and reliable HPV DNA test which is now available in low~     income countries has a potential to be accepted as primary screening test in future.~      The cross-sectional studies from developed countries from year 1999-2004 which focused to~     determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and~     higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%.~      Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have~     focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and~     higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average~     sensitivity of 79%.Among the developing countries cross-sectional study from India which~     evaluated test reported sensitivity of only 68.2%.~      There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA~     HC2 test between the developed and developing countries to determine CIN2+ Lesions while~     there is no difference in the specificity.~      A study that was conducted in Chinese women to detected the prevalence of HPV genotype among~     women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author~     reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis~     as compared to other two groups.~      So the study will explore if if the presence of untreated co-infections with STIs/RTIs~     (Sexually transmitted infections/Reproductive tract infections) resulting in cervical~     inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of~     blood and excess mucus associated with the conditions leading to low sensitivity of the test~     in context to Indian Scenario.~   "
17349|NCT02830217|"~     ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden~     myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary~     intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients~     are readmitted shortly after the primary PCI for several unfavorable clinical outcomes~     including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart~     failure. This study is intended to test the predictive ability of a new biomarker soluble~     ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly~     associated with unfavorable clinical outcomes of patients with ischemia heart diseases and~     heart failure. This study will further investigate the ability of sST2 to predict~     unfavorable outcomes for STEMI patients after primary PCI.~   "
17350|NCT02830204|"~     The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3~     valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis~     (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed~     inoperable due to the extent of calcification.~   "
17351|NCT02830191|"~     Ciclosporin A (CsA) is an immunosuppressive drug used in organs and tissues transplantations~     (kidney, heart, liver, bone marrow ...) to prevent rejection, and in different autoimmune or~     inflammatory diseases. A therapeutic drug monitoring (TDM) is required during a CsA~     treatment. It is justified by a narrow therapeutic range between efficiency and~     nephrotoxicity, and by large intra- and interindividual pharmacokinetic variability. TDM of~     CsA is conventionally performed by determining residual concentration, and sometimes~     concentration at 2 hours after administration. TDM of CsA is currently performed by venous~     sampling on ethylenediaminetetraacetic acid (EDTA). Dried blood spot (DBS) sampling could be~     a particularly interesting alternative to conventional blood sampling. With DBS, capillary~     blood is obtained from a finger prick by the patient himself, and the blood drop obtained is~     deposited on filter paper, which can be stored at room temperature and then be sent to the~     laboratory by mail.~      This sampling method has several advantages : it requires small blood volumes, it is less~     invasive than conventional venous sampling, sampling can be performed by the patient himself~     at home few days before the consultation, and the results of the analysis can be available~     to the clinician on the day of consultation, allowing dose adjustment more quickly.~      Several studies have been published in recent years using DBS sampling method, for various~     drugs such as antimalarials, antiepileptics, antiretrovirals, metformin, benzodiazepines, or~     immunosuppressants. Only one clinical validation study of TDM of CsA using DBS method was~     published by Wilhelm et al. (2013) in a population of 38 patients who received allogeneic~     stem cell transplant recipients. The results showed excellent correlation between the~     concentrations determined by the two sampling methods.~      The investigators propose an observational study at the University Hospital of Caen for~     clinical validation of DBS sampling for TDM of CsA in kidney transplantation, for which~     there are no data published. During a nephrology consultation, for each patient, venous and~     finger prick blood samples are simultaneously collected. CsA assays were performed by liquid~     chromatography-tandem mass spectrometry (LC-MS/MS) for the two sampling methods. A specific~     LC-MS/MS assay method applied for DBS samples was developed and validated for this study~     (DBS/LC-MS/MS). Correlation between the results obtained from the two sampling methods will~     be evaluated, on at least 100 samples. Patients have to answer a questionnaire to assess~     pain and comfort of DBS sampling, and feasibility of self-sampling at home by this method.~     The aim of this clinical validation study of DBS sampling is the establishment of the~     systematic TDM of CsA for renal transplant patients by DBS sampling at the University~     Hospital of Caen.~   "
17352|NCT02830178|"~     The Purpose of this study is to examine whether evidence of channeling exists by analyzing~     within a cohort of participants with first prescriptions of single-ingredient paracetamol or~     ibuprofen (or both) whether participants with paracetamol were more likely to have an~     ibuprofen-related contraindication.~   "
17353|NCT02830165|"~     This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients~     with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery.~     SBRT is a type of external radiation therapy that uses special equipment to position a~     patient and precisely deliver radiation to tumors in the body. Delivering radiotherapy~     before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues~     better than delivering radiotherapy after prostatectomy.~   "
17354|NCT02830152|"~     Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF)~     poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is~     a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio~     of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the~     effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in~     patients with NVAF and prior ICH.~   "
17355|NCT02830139|"~     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal~     metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the~     trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal~     resection in terms of overall survival.~   "
17356|NCT02830126|"~     The purpose of this study is to implement an Anesthesiology Control Tower (ACT). This pilot~     study will employ the existing information technology infrastructure at Barnes Jewish~     Hospital to create a remote monitoring and alerting system for the operating rooms. Similar~     to telemedicine methods employed in critical care, the ACT will support operating room~     clinicians in adhering to best-practice principles.~   "
17357|NCT02830113|"~     This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT)~     of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive~     protein(CRP) level amongst non-diabetic subjects.~   "
17358|NCT02830100|"~     The goal is to define what is the nature of intern speech, how it manifests itself, who deal~     with agency in intern speech and finally what is the role of intern speech in attention~     tasks.~   "
17373|NCT02829905|"~     Study will develop, validate and pilot measures to assess quality of experiences of~     mammography. Pilot data collection and analysis will investigate modifiable factors most~     important in determining quality of patient experiences of mammography.~   "
17362|NCT02830048|"~     Diabetes is a chronic condition that affects 1 in 16 people in the UK, and leads to~     difficulty controlling blood sugar levels. This is due to an imbalance between two main~     hormones: insulin, which lowers blood sugar, and glucagon, which causes it to rise. Most~     current anti-diabetic medications work to improve insulin levels, however research is now~     shifting to better understand how glucagon levels play a key role in this disease.~      Glibenclamide is a type of anti-diabetic medication (sulfonylurea) which is commonly used to~     increase the amount of insulin released by the pancreatic beta-cells. Studies in mice and~     human cells from donors with type 2 diabetes have shown that sulfonylureas can also improve~     glucagon levels when used in very small doses by working on different cells in the pancreas~     (alpha-cells).~      The aim of this study is to find out whether low doses of glibenclamide can improve glucagon~     levels in patients with type 2 diabetes, and whether in the future this could be used to~     better control high blood sugar levels, without the risk of causing low blood sugar.~      Participants with type 2 diabetes who are diet-controlled or on metformin will be given a~     liquid containing a low dose of glibenclamide. They will need to attend the OCDEM Clinical~     Research Unit at the Churchill Hospital, Oxford, for early morning blood tests every 3-4~     days over a period of 3 weeks. A continuous glucose monitor will also be fitted during this~     time.~      This study is funded by the NIHR OxBRC.~   "
17363|NCT02830035|"~     The purpose of this study is to compare the clinical efficacy of real-time ultrasound~     guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing~     success rate of spinal needle insertion, success rate rate of single needle pass, duration~     and immediate complications.~   "
17364|NCT02830022|"~     Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and~     behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to~     ASD. The investigators proposed to explore the impact of physical activity on these~     disorders. In this context, it is necessary to characterize the cardiorespiratory capacities~     of ASD children in order to promote physical activity for this population. To examine~     potential differences between ASD and control children, some explorations were proposed: a~     maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of~     autonomic nervous system).~      An actimetry during one week (evaluation of physical activity and sleep) completed this~     study in order to specify sleep characteristic and established the possible link between~     physical activity sleep characteristics and physical fitness in ASD children.~   "
17365|NCT02830009|"~     The aim of this study is to know the difference between protein profiles (multi-analyte~     profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients~     'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also~     leads to the formation of kidney stones.~      The aim is to identify patterns of discriminating markers associated with primary~     hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.~   "
17366|NCT02829996|"~     Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of~     topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in~     subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.~      All subjects who meet the study's enrollment criteria following Screening will undergo~     washout of all prohibited medications (if washout is needed), including their routine~     glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to~     both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes~     for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing~     in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active~     drug product. During the Treatment Period, study drug (Active and Placebo) eye drop~     applications will occur twice daily, in the morning and in the evening. The Treatment Period~     will be followed by an Observation Period of approximately 7 days wherein no study eye drops~     are instilled.~      The purpose of the study is to assess the overall benefit/risk profile of binocular topical~     application of different doses of trabodenoson (3.0% and 6.0%) when combined with~     latanoprost (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.~   "
17367|NCT02829983|"~     To assess the periodontal clinical response and the possible adverse effects of the~     clarithromycin combined to periodontal mechanical therapy in the treatment of patients with~     generalized aggressive periodontitis.~   "
17368|NCT02829970|"~     There are currently no published randomized controlled studies examining psychosocial~     interventions for college students with ADHD, and none specifically targeting AUDs in this~     population at any age, despite the clear indication from emerging research of the need for~     such interventions. In the current study, the investigators will develop BA-based treatment~     intended to increase involvement in healthy, goal-directed activities (e.g., academic,~     recreational or social activities) and to reduce problematic drinking behaviors and other~     risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation~     for Attention & Alcohol Disorders; BAAAD). Finalized treatment manuals, altered based on~     focus group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80~     college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The~     investigators expect that BMI + BAAAD will be successful with college students with ADHD, in~     terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI~     + SC. This treatment development study will set the stage for larger-scale RCTs.~   "
17369|NCT02829957|"~     A large proportion of women with menstruating potential with newly diagnosed VTE or atrial~     fibrillation, treated with apixaban will have less menstrual blood loss than patients~     randomized to rivaroxaban.~   "
17370|NCT02829944|"~     The purpose of this study is to determine if the infusion of the local anesthetic~     ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a~     pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery~     incision, will reduce the pain experienced after cesarean section and need for narcotic pain~     medicine.~   "
17371|NCT02829931|"~     The main purpose of this study is to evaluate the safety and tolerability of nivolumab,~     given in combination with hypofractionated stereotactic re-irradiation of recurrent high~     grade gliomas.~   "
17372|NCT02829918|"~     This research study is designed to see if a drug called Nivolumab is effective in treating~     patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the~     U.S. Food and Drug Administration (FDA) for treatment of certain types of cancer but is not~     approved by the FDA for treatment of your type of cancer.~   "
17374|NCT02829892|"~     Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the~     relationship with the environment and empower people. Patients with AD present in 90% of~     cases of behavioral disorders and of these behavioral disorders include agitation, apathy~     but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy~     on the behavior of patients with AD. The main objective of the study was to assess the~     influence of environmental light nighttime sleep of residents.~   "
17375|NCT02829879|"~     Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in~     response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to~     any dental condition or pathology. Multiple therapies for the treatment of DH have been~     studied, including equivocal evidence about the efficacy of potassium nitrate salts and~     recent investigations a promising new 8% Arginin dentifrice.~      Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm~     sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2)~     dentifrices in the treatment of dentin hypersensitivity.~      Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy~     volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile,~     with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar~     teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8%~     arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium~     nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene~     habits will be recorded in a clinical chart, while O´Leary plaque index and dentin~     hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks.~     DH will be evaluated through the mean VAS value in response to evaporative and thermal~     stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11~     program.~   "
17376|NCT02829866|"~     Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are~     constantly looking to improve all aspects related to this procedure weather is improvement~     of implant design, instrumentation or surgical technique. Excellent clinical and~     radiological results were observed at medium and long term in the last years for AMIStem~     system.~      This observational study has the objective to survey hip prosthesis stability and function~     of the operated hip in patients who are not exposed to surgical risks. The principal~     investigator will contact all patients in order to perform the follow-up visit according to~     standard practice. Patients operated between January 2010 and December 2011 will be invited~     in the study during the clinical visit organised according to standard practice.~     Preoperative clinical and radiological data, intraoperative details and postoperative~     follow-up data at 1-year will be retrospectively collected. Five-year data will be~     prospectively collected after inclusion in the study.~   "
17377|NCT02829853|"~     Major impacts of air pollution are lung diseases such as granulomatous diseases and mainly~     sarcoidosis. Understanding the respective role of inorganic / nanoparticles and genetic~     background in these chronic diseases is a major challenge for the management of patients and~     prevention strategies. Granulomas are characterized by giant epithelioid and multinucleated~     cells, reflecting a severe disturbance in immunological pathways induced both by toxic~     exposure and genetic predisposition. Previous studies demonstrated that professional~     environmental context and acute exposures (the World Trade Center disaster) to~     micro/nanoparticles have a pathogenic impact with a sharp increase in sarcoidosis.~     Sarcoidosis is a multifactorial disease occurring in a genetically vulnerable context. Many~     gene variants have been linked to an increased odds-ratio of the disease, such BTNL2,~     CCDC88B, ANNEXIN A11 involved in regulation of T-cell activation and maturation pathways. We~     have contributed since 2008 to a national cohort (GSF, 28 centers) of ≈ 800 sarcoidosis~     patients with familial and sporadic presentation of the disease. This collection has been an~     exceptional (and worldwide unique) tool for the implementation of an exhaustive clinical~     database on sarcoidosis, modelling of disease evolution and identification of clinical /~     genetic criteria differentiating sporadic and familial forms.~      The main goals of the project are:~        1. Completion of the genetic data in order to establish a pattern of gene variants~          segregating with familial forms of the disease, compared to sporadic one. This will be~          done by WES (WHOLE EXOME) analysis on the previously collected DNA samples. The~          informed consent for the patients included the information about the BTNL2 gene, which~          has been already tested since 2008, and related genes connected to immune pathways,~          thus allowing a unambiguous information about the research finality of the project.~        2. Completion of the clinical data about each patient, in cooperation with the GSF~          network, management of the database established since 2008. The data collected are~          those which are commonly detailed in the normal follow-up of the patients. The project~          do not include any new interventions on the patient (neither radiological or invasive~          tests).~        3. Specific biological studies might be done on the white blood cells of the patients, and~          might need in such cases a new blood sampling, both in patients and first degree~          related healthy controls. Theses specific studies will be presented to an ethical~          committee (CCP) in order to validate the feasibility in term of 'new intervention' on~          the cohort. The samples collected will be at the same volume of a classical blood~          sampling (2*7 ml).~        4. Any other projects, submitted to the GSF network will needed a specific registration~          and ethical committee validation.~   "
17378|NCT02829840|"~     The goal of Part 1 of this clinical research study is to learn if ponatinib alone can help~     to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this drug will also~     be studied.~      The goal of Part 2 of this clinical research study is to find the highest tolerable dose of~     ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can~     help to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this~     combination will also be studied.~   "
17379|NCT02829827|"~     The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics~     and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant~     infantile spasms~   "
17380|NCT02829814|"~     The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg~     tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.~      The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for~     fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results~     provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects~     upon pain, sleep and other FM symptomatology.~   "
17390|NCT02829684|"~     Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth.~     PWS represents a large fraction of mental retardation syndromes due to a genetic cause and~     the most frequent cause of genetic obesity. The majority of the patients are seen by~     paediatricians. This syndrome is responsible for severe physical, psychological and social~     impairments.~      The diversity and the severity of the manifestations of this disease explain the requirement~     of multidisciplinary care which deserve specific evaluation. Today the follow-up and~     management of a great proportion of these patients are greatly insufficient if not absent.~      Teams strongly lack information on the natural history of this severe disease and on the~     factors involved in its evolution and the outcome of these patients throughout life. The~     present project is to implement a register in the whole country for children and adult~     patients~   "
17381|NCT02829801|"~     The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in~     geriatrics. Many studies have shown a link between the presence of the animal and the~     psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or~     irritability that affects their quality of life and improved cognitive abilities. However,~     many methodological flaws in these researches exist.~      The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients~     with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short~     and medium term (before care, during care (at the beginning and end of each session), 1 week~     after, 2 weeks and 1 month after the last session) compared to a group receiving the same~     stimulation without the dog's response.~      Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed:~     AAT group versus control group. The only difference between these two groups is the~     intervention of the dog at each workshop in the AAT group.~      Each workshop will consist of three identical times. It will begin with a 15 minute~     introductory activity, the first goal will be to establish a relationship with patients~     (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical~     in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of~     the session This study should highlight a positive effect of animal assisted therapy on the~     well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of~     these positive effects.~   "
17382|NCT02829788|"~     The peritoneum is the second most common site of recurrence in patients with colorectal~     cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the~     prognosis of these patients and incorporates surgical removal of all visible disease~     followed by chemical destruction of microscopic disease through chemoperfusion. The most~     validated predictors of outcome are preoperative tumor burden measured in terms of the~     peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score).~     Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and~     colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy~     associated with higher morbidity.~   "
17383|NCT02829775|"~     This open label extension study will give an opportunity to the participants that have~     responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant~     Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal~     Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for~     Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant~     Melanoma (MM).~   "
17384|NCT02829762|"~     The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of~     geriatric and Social intervention associated techniques of Domotic and Remote assistance~     (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of~     isolation, treated for locally advanced or metastatic cancer.~   "
17385|NCT02829749|"~     The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair~     technique as compared with conventional open-heart on-pump mitral valve surgery in patients~     with severe primary mitral regurgitation.~   "
17386|NCT02829736|"~     Chest tubes are used routinely although preliminary studies demonstrate the feasibility and~     safety of intraoperative chest drain removal. Previous studies are however either~     retrospective or mainly concerning benign disease.~      Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge~     resection have less pain, better pulmonary function and similar complication profile than~     participants treated with standard post-operative chest tube, and could possibly be~     discharged earlier.~   "
17387|NCT02829723|"~     The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in~     combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent~     or in combination with PDR001, administered intravenously (i.v.) in adult patients with~     advanced solid tumors.~      Dose escalation will be guided by a Bayesian logistic regression model with overdose~     control. Once MTD/ RP2D is declared, patients will be enrolled in the phase II part in the~     selected indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to~     further assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001.~     Should signs of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as~     single agent, a phase II part will be opened in order to further explore BLZ945 single agent~     efficacy at the recommended dose.~   "
17388|NCT02829710|"~     Management of analgesia and sedation is an integral component of the medical care of a~     critically-ill child. Its role is to assure comfort and safety to a patient undergoing~     painful cares and technical procedures; it can also be, in particular situations like acute~     respiratory distress syndrome or acute brain injury, a full processing treatment.~      Sedation involves, most of the time, the association of an opioid and a sedative. The use of~     these drugs is difficult in children, because of a specific metabolism, inducing tolerance~     and withdrawal in case of prolonged administration.~      The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible~     score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to~     avoid inadequate sedation.~      Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation,~     longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data~     suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the~     treatment to the patient's need and permit a reduction in the duration of mechanical~     ventilation.~      The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric~     intensive care unit on duration of mechanical ventilation, total doses and duration of~     medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of~     ventilator-associated-pneumonia and occurrence of withdrawal.~   "
17389|NCT02829697|"~     The aim is to investigate the effect of perineural administration of a series of different~     volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability~     of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.~      The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but~     only to a certain degree. After a sufficient volume a 'saturation level' will be reached,~     and nerve block duration will not increase further.~   "
20006|NCT02795325|"~     A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine~     the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1~     administered via-intravenous infusion (IV)~   "
17391|NCT02829671|"~     Suicide is a major health problem that causes annually a million death worldwild. Loneliness~     is known to be associated with suicidal ideation in minors and to be related with suicidal~     risk in elerly people. However little is known about this association in a middle-aged~     population. Loneliness is a modifiable factor with suitable psychotherapeutic measures, it~     is essential to improve the scientific and medical knowledge about the link between this~     feeling and suicide risk in a population of depressed patients in middle age.~      The main objective is the study of the relationship between loneliness and the occurrence of~     SB in major depressed adult population over 12 months.~      The secondary objectives are:~        -  Identification of risk factors (clinical, neuropsychological and biological) of the~          occurrence of SB within a clinical population and their interaction;~        -  Identification of predictive factors (clinical, neuropsychological, biological)~          therapeutic response to antidepressant in the context of depression.~   "
17392|NCT02829658|"~     Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability~     and impulsivity. Several North American prospective studies support the high level of mental~     health care utilization in this population. There is little data in other systems of health~     organization, such as France. Furthermore, little is known on the variables associated with~     the mental health service utilization among BPD patients.~      The main objective was to compare the utilization of mental health care among BPD patients,~     to the general population and patients with another personality disorder (PD) and to~     describe the demographic and clinical factors associated with the group of patients who use~     the most health care.~   "
17393|NCT02829645|"~     Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects~     in the quality of life of patients and thier relatives. Management of ED is very difficult :~     the prognosis remains relatively poor both in terms of remission rate and quality of life.~     In this context, the contribution of new strategies for pathophysiological exploration and~     the development of therapeutic options are crucial.~      In this project the investigators aim to constitute un cohort of patients from a day unit~     specialized in the management of ED. A prospective follow-up will be offered to patients to~     assess their clinical and psycho-social evolution. The overall objective is to identify~     which factors are prognostic of clinical improvement of the ED. We also want to better~     characterize patients that will migrate from diagnosis to another.~   "
17394|NCT02829632|"~     Brief Summary: This randomized clinical pilot will test the feasibility of having~     individuals self-monitor for 12 weeks and based on what the participants record be given~     feedback messages. The investigator will use this information to refine the questions and~     data collection procedures for the larger study.~      Participants will be randomized into 3 groups~        -  self-monitoring only~        -  self-monitoring w/ feedback messages~        -  self-monitoring w/feedback messages and group sessions Feedback messages will be~          delivered up to 4 times per day using a different schedule. The group sessions will be~          held in the 2nd, 4th and 8th week of the 12-week study.~      All participants will be asked to complete questionnaires and 2 assessment visits at~     baseline and 12 weeks.~   "
17395|NCT02829619|"~     Meal times differ from culture to culture. These differences may influence energy regulation~     and, consequently, body weight. Current studies support the notion that not only what but~     also when the investigators eat may have a significant role in obesity treatment.~     Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in~     the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This~     project aims to study in a Mediterranean population the potential influence of genetics and~     food timing on obesity, metabolic syndrome and weight loss.~   "
17396|NCT02829606|"~     A device has been developed that has eye trackers integrated within the Head Mounted Display~     (HMD) and can remap text and images around the scotoma in real time to prevent information~     loss from a central scotoma. It can also carry out other types of image processing such as~     contrast enhancement and image magnification. The aim of this study is to assess the~     efficacy of this device on the visual performance of participants suffering from central~     vision loss, with and without remapping~   "
17397|NCT02829593|"~     You are invited to participate in a study designed to investigate the effects of diabetes~     mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a~     possible participant because you fit into one of the following categories. a) you are either~     healthy and competent, are not pregnant and you have no known medical disease and therefore~     your glucose metabolism will be typical of a normal person, or b) you have diabetes.~   "
17398|NCT02829580|"~     Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises~     with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial~     stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances~     such as nitric oxide.~      The present study assess the vascular properties of carotid and brachial arteries in~     children with SCD compared with a control group without cardiovascular risk factors.~   "
17399|NCT02829567|"~     The purpose of this study is to determine whether motivational interviewing is effective in~     improving oral hygiene in orthodontic patients wearing fixed appliances.~   "
17400|NCT02829554|"~     Background:~      Researchers are testing new methods for research projects. They want to see how people~     respond to different types of communication, including videos. They also want to learn how~     people respond to life events and how they pay attention to computer tasks. They want to~     learn about how various risks and threats affect the way people make decisions.~      Objectives:~      To learn how different stimuli and events affect the way people make decisions.~      Eligibility:~      Adults ages 18 and older with a U.S. computer address~      Design:~      Participants will be recruited online.~      Participants will take one of three studies online. Each study will take about a half hour.~      Participants in Study 1 will watch a short video from a popular movie then answer questions.~     They will also complete 2 questionnaires. One will be about how likely they think it is that~     they will experience different risks and threats. The other will be about goals for behavior~     change.~      Participants in Study 2 will write in detail about a life event. Then they will answer~     questions. They will also complete the same 2 questionnaires as Study 1.~      Participants in Study 3 will pay close attention to words and images on a computer. They~     will answer questions about attitudes toward different behaviors, products, and experiences.~   "
17401|NCT02829541|"~     The primary objective of the study is to evaluate the safety and tolerability of single oral~     doses of BIIB068 in healthy participants. Secondary objectives are to characterize the~     single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the~     effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine~     the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the~     single-dose PK of BIIB068 in healthy participants.~   "
17402|NCT02829528|"~     An initial evaluation of Little Flower Yoga for Kids will be conducted in a small sample of~     18-30 Kindergarten and First Grade students (3-5 per class) enrolled in Girls Preparatory~     Charter School of the Bronx. The overall aim of this study is to ascertain the short and~     longer-term effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program~     for children, which incorporates five elements (connect, breathe, move, focus, relax) to~     improve the child's ability to sustain attention and regulate emotions.~   "
17403|NCT02829515|"~     For the purpose of quality assurance, the Swedish Association for Otorhinolaryngology and~     Head and Neck surgery has developed several national registers concerning ear, nose and~     throat care. One of these is the National Tonsil Surgery Registry in Sweden (NTSRS). In~     NTSRS patients undergoing tonsil surgery for benign indications are included. Data regarding~     indication, surgical methods and techniques as well as patient reported outcomes measures~     are collected. The register is designed to facilitate description of clinical activities in~     a unit and help identify the need of clinical improvement programs. By compiling national~     data, the register can be used to describe clinical practice in a large national cohort.~   "
17404|NCT02829502|"~     This randomized controlled trial investigates the effect of a single dose of glucagon-like~     peptide-1 (GLP-1) receptor agonist in the subacute phase of stroke in humans. The primary~     endpoint is the mean flow velocity in the middle cerebral arteries measured by transcranial~     doppler and cortical oxygination measured by near infrared spectroscopy (NIRS). The~     secondary endpoints are changes in endothelial/inflammatory biomarkers in the blood, changes~     in the ankle-brachial index and changes in the reactive hyperaemia index measured by~     EndoPAT2000.~   "
17405|NCT02829489|"~     The purpose of this study is to evaluate the current state of nutrition care and patient~     related outcomes in patients with head, neck and esophageal cancers in North America, Europe~     and Australia.~   "
17406|NCT02829476|"~     Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to~     secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the~     origin of this illness. Recently, the melatonin pathway has been investigated as~     pinealectomy of the chicken creates a scoliosis that resembles AIS and melatonin~     supplementation reverses the process. In addition administration of melatonin to AIS~     patients improved the pathology. However this hypothesis has shown controversial results.~     Recent studies have demonstrated melatonin cellular resistance in osteoblastic cells from~     AIS patients. Melatonin acts through G protein coupled receptor (GPCR), mainly using the Gi~     pathway. In AIS osteoblasts, this pathway is blocked leading to a decrease in the~     inactivation of the adenylyl cyclase and therefore maintenance of high level of cyclic~     adenosine monophosphate (cAMP) concentrations in the cells. As modulation of cAMP is~     important for osteogenesis such resistance may be critical for the initiation or the~     development of AIS.~      Gi signalization is used by several other GPCR, thus, this hormonal resistance could~     logically be found in other hormonal or mediator pathways. A precedent study previously~     focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic~     values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures~     osteoblasts.~   "
17407|NCT02829463|"~     In this study, the investigators use the clinical documentation and imaging data of MRI to~     do research. Clinical subjects were divided into two groups: osteoarthritis patients and~     healthy controls without osteoarthritis. Differences of MRI data were studied between two~     groups.~   "
17408|NCT02829450|"~     The purpose of this study is to determine whether the treatment of peritoneal~     ultrafiltration can improve survival and quality of life of refractory congestive heart~     failure with special accent on preserving residual renal function and peritoneal membrane~     characteristics/~   "
17409|NCT02829437|"~     Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)~   "
17410|NCT02829424|"~     The overall purpose of this trial is to assess efficacy and safety of the combination of low~     doses of Methotrexate (MTX) with anti Tumor Necrosis Factor (TNF) alpha to improve initial~     efficacy and maintenance rate of anti-TNF alpha treatment in patients with psoriasis.~   "
17411|NCT02829411|"~     The project will test the strategy of integrating 25 hours of relationship education into an~     existing employment program for low-income individuals ages 18-30. It will use a 2-arm~     randomized controlled trial to test the effect of this full package of services on~     participants' employment outcomes and relationship outcomes.~   "
17412|NCT02829398|"~     The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is~     associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for~     DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the~     prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived~     variables to be used alone or in combination for prediction of DCI~   "
17413|NCT02829385|"~     This study makes an observation over the objective response rate of Apatinib and XELOX~     combination regimen in the first-line treatment of metastatic colorectal cancer. All the~     participants will receive the treatment of Apatinib and XELOX combination regimen.~   "
17414|NCT02829372|"~     The purpose of this study is to determine the safety profile and maximum tolerable dose~     (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers~   "
17415|NCT02829359|"~     Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related~     hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA~     . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum~     HBV-DNA negative HBV-related HCC are unclear.~   "
17416|NCT02829346|"~     This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty~     which is an alternative route of administration for blood loss reduction. Half of~     participants will receive intravenous tranexamic acid injection, while the other half will~     receive peri-articular tranexamic acid injection during total knee arthroplasty.~   "
17418|NCT02829320|"~     This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the~     efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia~     not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the~     initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using~     ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the~     starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or~     maintain the target Hgb levels. This study will consist of a 4-week screening period, a~     24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period),~     and a 2- to 4-week follow-up period.~   "
17419|NCT02829307|"~     GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the~     body, and by itself, has no pharmacological action. A pharmacologically active drug can be~     attached to GSK3128349 with the goal of changing the distribution and/or duration of action~     of the attached drug. This study will determine the distribution and pharmacokinetics~     (duration) of GSK3128349 itself after a single intravenous infusion. GSK3128349 has been~     labeled with and the radioisotope 89Zirconium allowing it to be visualized in the organs of~     the body using a PET scanner at multiple time points after GSK3128349 dosing. The data from~     this study will help predict the distribution of future drugs attached to GSK3128349. The~     total duration of a subject's participation is about approximately 10 weeks, including the~     screening period.~   "
17420|NCT02829294|"~     This is a prospective, open-labeled clinical trial. Subjects that qualify for enrollment and~     provide informed consent will be treated with a novel topical cerumen (earwax) removal~     product. The primary goal of this pilot study is to gain an understanding of the safety and~     efficacy of this novel product.~   "
17421|NCT02829281|"~     Introduction: Osteoarthritis of the knee is a very common disease. However there are few~     treatment options for these patients. Botulinum toxin type A is an option for chronic pain.~     If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum~     toxin type A can be useful for treat these patients.~      Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus~     Botulinum toxin type A in the treatment of patients with knee osteoarthritis.~      Methods: A prospective controlled randomized double blind studied with three groups (n = 35~     each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular~     medication in a single moment will be undertaken. The three groups will be: Botulinum toxin~     type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of~     triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline~     group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators ~     blind  in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain,~     quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC~     questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial~     hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be~     used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures .~     Will be considered as statistical significance the difference of 5 %.~   "
17422|NCT02829268|"~     The purpose of this study is to assess the safety and tolerability of dantrolene sodium in~     patients with Wolfram syndrome. Wolfram syndrome is a rare genetic disorder, causing~     diabetes mellitus, optic atrophy, and deafness as well as various other possible disorders~     including premature death in most patients.~      There is a screening period up to 28 days, a 24-week treatment period, and a 4-week safety~     follow-up period. Study assessments include medical & medication history, physical exams,~     neurological exams, eye exams, endocrine exams, vital signs, height, weight,~     electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.~   "
17423|NCT02829255|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on cerebral autoregulation~   "
17424|NCT02829242|"~     Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon~     dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less~     postoperative pain, shorter hospital stay and faster recovery. After prolonged operative~     time in a Trendelenburg position rare but significant complications are a cerebral oedema or~     a well leg compartment syndrome.~      Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the~     perfusion pressure is decreased proportionally to the lower extremity elevation. The~     condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia~     and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after~     4 hours in a Trendelenburg position.~      If not promptly diagnosed and treated, a compartment syndrome has devastating complications~     like permanent dysfunction, limb loss, renal failure or even death.~      There are no specific guidelines for diagnosis and for the timing of surgical decompression.~     Fasciotomy is a clinical decision. There is no universal agreement at which compartment~     pressure irreversible muscle damage occurs.~      The only objective diagnostic tool available is currently to measure the intramuscular~     pressure, however this is invasive, painful and may yield unreliable results. An~     intracompartment pressure of 0- 10mm Hg is the normal range.~      Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral~     and somatic tissue oxygenation below the sensors and may help detecting promptly a~     compartment syndrome.~      Therefore, the investigators designed the present study to detect a change in the tissue~     oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the~     Trendelenburg position.~   "
17425|NCT02829229|"~     The purpose of this study is to determine the effect of the community-based obesity~     treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.~   "
17426|NCT02829216|"~     The objective is to measure the frequency, functionality and phenotype of bone~     marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem~     cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be~     monitored at the same time. These results will be correlated with the extent of cytopenia~     and clinical graft-versus-host disease grading.~   "
17621|NCT02826681|"~     Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750~     mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency~     anemia (IDA).~      Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior~     FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS~     symptoms worsen or reoccur.~   "
17427|NCT02829203|"~     Frailty is an important risk factor for cardiovascular disease (CVD), recent data has shown~     significant association between pre-frailty and the risk of incident for CVD, irrespective~     of any classical cardiometabolic risk factors, suggesting that targeting pre-frailty as a~     potentially reversible risk factor for CVD in the elderly. Patients with high levels of~     frailty have an increased risk in post-operative period, with more time in mechanical~     ventilation, length of stay and complications (stroke and death) compared to patients with~     low frailty levels. The investigators hypothesized that pre-frailty patients also have a~     higher surgical risk compared to no-frailty patients.~   "
17428|NCT02829190|"~     The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements~     data with morphological images.~      Even if the anatomy of the external carotid artery is well known, data obtained through~     Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial~     surgery as for example arteriovenous malformations,radionecrosis, head and neck~     micro-reconstructive surgery.~      The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular~     flow characterization branches of the external carotid artery in healthy patients and in~     pathological cases.~   "
17429|NCT02829177|"~     The objective is to determine if lowering serum uric acid by means of allopurinol in the~     course of kidney disease may be effective in preventing or improving albuminuria and renal~     function in Type 1 Diabetic patients. The study is a double blinded, randomised,~     placebo-controlled cross-over clinical trial.~   "
17430|NCT02829164|"~     Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura~     nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes~     in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's~     disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share~     biological and histological characteristics, as well as common pathophysiological~     mechanisms, particularly the production of abnormally glycosylated IgA1 promoting their~     proliferation in the mesangium. Tonsils part of Iga abnormal production sites that would be~     associated with an infectious stimulus, tonsillectomy has been studied as a possible~     treatment in primitive IgA nephropathy. The benefit of tonsillectomy is controversial: many~     Japanese studies demonstrate its effectiveness in terms of reduction of proteinuria,~     improved renal function in the long term regression of histological lesions and reduced risk~     of relapse following clinical remission whereas European studies do not suggest its~     effectiveness in treating IgA nephropathy. In this context, the aim of our study is to~     describe the scope of practice of tonsillectomy in the treatment of primary renal disease in~     IgA child in the inter East region and describe the short renal become Strasbourg end of the~     cohort that received this treatment.~   "
17431|NCT02829151|"~     -  Prospective, randomized, controlled, multi-center study~        -  A total of 390 subjects with critical limb ischemia will be included according to~          inclusion and exclusion criteria.~        -  Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP:~          aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin,~          clopidogrel) A group, or DAP (aspirin, cilostazol) B group.~        -  All patients will be treated with angioplasty for critical limb ischemia.~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be~          performed at 1 year.~   "
17432|NCT02829138|"~     There are many health benefits associated with the consumption of omega-3 dietary fats.~     Omega-3 fats, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can~     be found in marine food products such as fatty fish, in fortified products such as eggs and~     milk, or in dietary supplements such as fish oil. Despite numerous health benefits, it is~     well documented that most people in Western society are not meeting the recommended daily~     amounts of EPA and DHA omega-3 fats.~      The overall objective of this study is to examine whether providing young adults (18-25~     years) with personal genetic information changes behavior with regards to omega-3 fat~     consumption. In order to achieve this objective, study participants will be divided into two~     groups: 1. Genetic and 2. Non-Genetic. The Genetic Group will be provided with their~     personalized information regarding a common gene variant in addition to general information~     regarding the health benefits of omega-3 fats, while the Non-Genetic Group will only receive~     the general information. Primary outcomes studied will include dietary habits and secondary~     outcomes include blood markers of cardiometabolic health.~   "
17433|NCT02829125|"~     The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced~     by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for~     patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid~     mobilization of patients. This strategy targets multiple elements (20 items) to support~     pre-, intra- and postoperative patients. This reduces the pain and the different organ~     dysfunction induced by surgical stress significantly decreasing length of hospital stay,~     postoperative morbidity and costs.~      Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies~     have analyzed the influence of preoperative exercise on postoperative rehabilitation.~   "
17434|NCT02829112|"~     Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually~     benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the~     clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic~     criteria validated for this rare disease. The low number of cases reported in the literature~     reflects the difficulty of studying the epidemiology of this disease, to establish and~     evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To~     our knowledge, no study has previously used to estimate the incidence and prevalence of this~     disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in~     2016 by a study capture-recapture using several independent sources of identification of~     cases in order to have recent epidemiological data and learn more about this disease.~   "
17435|NCT02829099|"~     The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and~     schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced~     stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when~     administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer~     and cutaneous melanoma in Part 2.~   "
17436|NCT02829086|"~     The US Committee for Refugees and Immigrants (USCRI) will be conducting an evaluation of a~     healthy marriage and relationship program developed by USCRI titled Refugee Family~     Strengthening (RFS) Program. This program is funded through an initiative of the~     Administration for Children and Families, Office of Family Assistance (OFA).~      The study is intended to measure if the identified interventions improve the well-being of~     individuals and families within the refugee and immigrant population served by USCRI.~     Outcomes to be measured include behavioral outcomes and perceptual changes towards healthy~     relationships, family development, and positive home environment. The study will examine the~     following:~        1. Participants will identify utilizing healthy marriage and relationship skills.~        2. Participants will report an increase in satisfaction with conflict management with~          others after completion of the relationship workshop series.~        3. Participants will report an increase in quality and time spent with children.~        4. Participants will report an increase in economic stability.~   "
17437|NCT02829073|"~     The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2~     disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom.~     Tinnitus can result from exposure to continuous noise from vehicles, generators, and other~     equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems.~     Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an~     obstacle to be overcome in return-to-duty decisions and represents a serious liability to~     the retention of a healthy and fit force. Until recently, there has been no treatment that~     has been clinically validated as consistently effective. The development of the Neuromonics~     Tinnitus Treatment sought to overcome the practical limitations of previously available~     approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated~     the efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials~     studied target populations that may not be representative of the typical Soldier~     experiencing tinnitus.~      One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be~     recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus~     Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a~     similarly-treated device using a placebo treatment. The study uses a randomized,~     double-blind design. The effectiveness of the treatments will be assessed using standard~     audiometric procedures and tinnitus subjective questionnaires.~      This study will allow the Office of the Surgeon General of the Army to provide direction~     regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating~     tinnitus that adversely affects Soldier deployability and operational performance. Retention~     of a fit force and improved quality of life for active-duty Soldiers are important issues~     associated with a successful approach to the treatment of tinnitus.~   "
17438|NCT02829060|"~     This study will be a multi-institutional randomized clinical trial of a short course of~     pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to~     undergoing percutaneous nephrolithotomy. The select patient population will be those~     patients deemed to be at a moderately increased risk of postoperative infectious~     complications. These higher risk patients are those with indwelling urinary drainage tubes~     and those with a positive preoperative urine culture.~   "
17439|NCT02829047|"~     The study is a prospective, multicenter, open-label, single-arm study, to evaluate the~     tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.~      One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2~     days, followed by one day without, one per day for 2 days followed by one day without, etc.~     (14 capsules in 3 weeks).~      The study will have one interim analysis.~      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 6 weeks.~      Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2~     weeks of baseline, patients will be asked to refrain from taking any medication or~     supplement to relieve their constipation.~      After 14 days the patients will return and eligibility will be re-assessed. Patients will be~     trained on how to use the base unit.~      Patients will be instructed to complete a simple patient eDiary each day throughout the~     duration of the study. After 3 weeks of treatment, the patient will attend for evaluation~     and to receive new capsules. A final visit will take place at the end of the 6 week~     treatment period.~      Patients will receive phone calls up to twice per week and patient compliance will be~     monitored during the 8 weeks of the study.~   "
17440|NCT02829034|"~     This study is looking to see if giving ranolazine to subjects on stable pulmonary~     hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their~     health by improving right ventricular (RV) function.~   "
17441|NCT02829021|"~     This study evaluate diagnostic accuracy of dynamic infrared thermography compared to~     mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected~     for assessment after mammography screening were invited to dynamic infrared thermography~     before clinical mammography and further examination.~   "
17442|NCT02829008|"~     This is a single-center, open, randomized, controlled phase 2 clinical trial designed to~     compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast~     cancer patients after failure of taxanes and anthracycline-containing regimens.~   "
17443|NCT02828995|"~     The Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA~     Study was designed to develop a comprehensive diabetes stigma survey measure. The draft~     measure will be piloted with approximately 50 patients visiting the Vanderbilt University~     Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new~     survey measure and to determine if any questions in the diabetes stigma measure are~     predictive of diabetes medication adherence.~   "
17444|NCT02828982|"~     The goal of this research is to determine the effectiveness of a powered prosthesis compared~     to an unpowered prosthesis during short bouts of walking, extended periods of walking (to~     fatigue), and performance in the community.~   "
17455|NCT02828839|"~     The objective of the study is to assess the design features of a modified stainless steel~     access needle (single use disposable) in a clinical setting and a disposable, single use,~     custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The~     disposable stainless steel access needle may be used with or without the disposable needle~     guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary~     purpose of the single-use disposable access needle is to guide the use of a biopsy gun to~     obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of~     the perineum. The primary purpose of the disposable needle guide is to stabilize the needle~     biopsy and better approximate the most direct path to the prostate.~   "
17734|NCT02825212|"~     10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated~     with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or~     non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects~     with cirrhosis).~      The researchers anticipate that approximately 20% of subjects may have cirrhosis.~   "
17445|NCT02828969|"~     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the~     basic rights of others or major age-appropriate norms are violated. So defined, these~     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder~     management is a public health issue and a societal question. Conduct disorders affect 5 to~     9% of 15-year old boys.~      Care management of children and adolescents admitted for disruptive behaviors in emergency~     rooms is an issue. No consensus or official recommendation exists. However, use of emergency~     care in this context is increasing in most western countries and it exposes to several risks~     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and~     suicide risk). The Trajectories project is designed to describe children and adolescents~     with disruptive behaviors, their care management and to follow their life trajectory and~     psychiatric evolution after admission to emergency rooms. Better understanding this~     population will improve their medical and social care management, thereby giving~     professionals the right tools.~      The main objective of this project is to implement a multidisciplinary and integrative~     research combining clinical considerations and social sciences to determine the trajectory~     of this population.~   "
17446|NCT02828956|"~     By use of several questionaires, this study aimed at an investigation of the changes in~     motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia~     nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire~     (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment~     period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed.~     Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the~     outcome of AN was assessed.~   "
17447|NCT02828943|"~     The purpose of the present study is to determine the utility and effectiveness of combined~     inspiratory (IMT) and expiratory muscle training (EMT) in improving ventilatory function in~     people who are disabled by long-term stroke (greater than 8 months following onset) with~     hemiparesis or hemiplegia. xx subjects will be randomized into 2 parallel groups in which~     the experimental group will undergo combined IMT and high-resistance EMT and the comparison~     group will undergo IMT with low- resistance EMT. Both training techniques involve breathing~     through a tube with known amounts of resistance. Subjects will perform the breathing~     maneuvers for 10 repetitions, twice daily, 5 days per week for 4 weeks, in the home~     environment. Adherence will be monitored by reminder telephone calls at least weekly.~     Outcomes will be assessed using maximum inspiratory and expiratory pressures and standard~     pulmonary function testing.~   "
17448|NCT02828930|"~     The purpose of this single-center, open-label, non-randomized study is to assess the~     excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of~     [14C]-labeled idasanutlin administered orally and [13C]-labeled idasanutlin administered~     intravenously in a single cohort of eligible participants. Participants will be screened for~     participation in this study within 21 days of receiving the first dose of study drug on Day~     1. Treatment period will continue up to Day 28 after which participants will enter 28 day~     follow-up or the optional treatment extension of idasanutlin, depending on safety parameters~     and as per opinion of the Investigator.~   "
17449|NCT02828917|"~     MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination~     product comprising:~        -  A mounted Cobalt Chromium (CoCr) alloy based stent~        -  A Rapid Exchange (RX) Coronary System Delivery System~        -  A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating~        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for~          improving coronary luminal diameter in patients with symptomatic heart disease due to~          lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex~          lesions.~      JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient~     population to show equivalence to the results of the BIONICS Trial.~   "
17450|NCT02828904|"~     The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate~     (CMA) is currently unknown as the available data have significant limitations and lack data~     on direct comparison between levonorgestrel (LNG) and CMA containing COCs. This new study is~     designed to assess the VTE risk associated with CMA containing COCs compared to LNG~     containing COCs in a large case-control study.~      The objective of this study is to compare the VTE risk of COCs containing CMA 2mg / EE 30µg,~     compared to COCs containing LNG 0.15mg and 30µg ethinylestradiol (EE).~   "
17451|NCT02828891|"~     This is a single center, prospective study to calculate cerebrospinal fluid pressure (CSFp)~     using a non-invasive device and assess its role in the development of optic neuropathy due~     to glaucoma or idiopathic intracranial hypertension (IIH). The study also aims to assess~     whether CSFp differs between untreated and treated patients with glaucoma, ocular~     hypertension, IIH, and other ocular diseases that may be associated with CSFp differences.~   "
17452|NCT02828878|"~     Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up~     period of 180 days after the transplantation of ApoGraft.~   "
17453|NCT02828865|"~     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers~     is one the most common malignancies in the world. Over 10000 new cases per year are~     diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains~     dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to~     85%) of patients present with advanced or unresectable disease. In contrast, small liver~     cancers can be cured with an appreciable frequency. Five-year disease-free survival~     exceeding 50% has been reported for surgical resection, and for the inoperable patients who~     do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is~     recommended as an alternative curative therapy. However, the main drawback of RFA is its~     limitation to tumor size and location. The tumors larger than 5 cm in diameter or located~     adjacent to vessels, could not be ablated completely sometimes.~   "
17454|NCT02828852|"~     The objective is to compare women's platelet answer in the last month of pregnancy to women~     old enough to procreate, no pregnancy and without hormonal treatment.~      The hypothesis of research is that the decrease of platelet answer in pregnant women could~     not only limit the occurence of embolic accidents but also explain the lowest incidence of~     the arterial thrombosis in comparison with the venous thrombosis.~   "
20349|NCT02790840|"~     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three~     AF-219 formulations; to assess the effect of Omeprazole on the multiple dose PK of three~     AF-219 formulations; and, to assess the safety and tolerability of AF-219.~   "
17456|NCT02828826|"~     At home, maintenance, physical performance declines more or less rapidly from 6 weeks~     depending advancing age and duration of the training period . It is feared that the advice~     or prescription of regular physical maintenance at the exit of the service, has only~     adherence to the 50% like the medication prescribed. A US study of 2000 on the observance of~     healthy living recommendations, despite the many messages promoting physical activity, shows~     that only 24% of Americans aged 65 to 74 were taking physical activity regular. There are no~     French-date data.~      If physical maintenance is routinely recommended for the elderly living at home, so the way~     to encourage these people to practice more often possible these recommendations remains~     therefore a problem of public health.~      The recent OSSEBO study (intervention for the prevention of injurious falls in elderly~     women: background and design) recalled the interest to propose a program of physical~     exercise to reduce trauma and falls in the elderly. It also shows the possibility to~     implement an effective program on a long-term and large scale in France. The study allowed~     patients to participate in collective sessions of physical exercises, within the framework~     of an association. Patients were invited to continue their home exercises they had learned.~      Also, the investigators hypothesize that the monthly telephone coaching , directed by the~     physical therapist following a physical fitness exercise program which they have been~     trained during their hospitalization in SSR , would allow older patients to maintain fallers~     their physical performance at home for at least 6 months after leaving~   "
17457|NCT02828813|"~     This study investigates the neural mechanisms of motor and cognitive networks using~     cognitive assessment, reaction time measurement, high-density EEG and fMRI.~   "
17458|NCT02828800|"~     The purpose of this study is to realize a cartography of the allodynic and hypoasthetic~     territories associated with a neuropathic pain appearing in patients who underwent a Total~     Knee Arthroplasty (TKA)~   "
17459|NCT02828787|"~     The main objective of this study is to identify by functional and structural MRI which are~     the brain areas activated in various pruritic situations to deduct a model describing the~     different causes of pruritus.~      The investigators are going to compare two chronic pruritus conditions (histaminergic~     urticaria and non histaminergic: psoriasis) to a healthy control group.~      The secondary objective of this study is to specify a classification index from the~     physiological results obtained by brain imaging to differentiate multiple types of pruritus.~   "
17460|NCT02828774|"~     Using phage libraries extensively pre-absorbed on a series of normal cell types, we will~     isolate phage specifically internalized by B-CLL cells from newly diagnosed and untreated~     CLL patients. Peptide sequences are then derived by Next Generation Sequencing (NGS).~     NGS-based studies are contributing to an improved understanding of cancer heterogeneity in~     order to tailor treatment to patients based on the individual makeup of their tumor. However~     the use of NGS to derive phage displayed peptide sequences is so far rare (22).~     Traditionally, after exposure to a target and recovery by elution, the phage clones are~     isolated by titration on bacterial lawns. It is technically demanding and labour intensive~     to select and analyze more than about 15 of the sometimes thousands clones recovered.~     Therefore information on other potentially important sequences is missed. NGS allows~     sequencing of the entire recovered phage pool and provides far more detailed bioinformatic~     analyses of peptide sequences or motifs. RNA from the CLL cells is used for RNA-seq~     expression sequencing. The wide application of NGS in combination with bioinformatics tools~     has begun to revolutionize cancer research, diagnosis and therapy. The peptide and RNA~     sequencing data will afford bioinformatic testing of correlations of exome expression and~     clinical parameters with the pattern of peptide sequences internalized by CLL cells of~     different patients. This information is crucial to answering questions 1, 2 and 3 discussed~     on page 1 above. The results of this analysis will probably not allow identification of~     specific receptors targeted by the peptides. The aim at this stage of the research is to~     identify candidate targeting peptides. Once identified, further research will be needed to~     identify the receptors to which they bind. Regarding question 4, there is currently very~     little published information on the therapeutic potential of PDCs in leukemia. Using two~     peptides we have isolated that target murine A20 leukemic cells, we will prepare multi-drug~     PDCs (using technology we have developed) and in an animal model, test their ability to~     enhance the survival and quality of life of CLL bearing animals.~   "
17461|NCT02828761|"~     This research asks whether coronary calcium scoring, a non-invasive test based on computed~     tomography scanning, is a better way to diagnose chest pain patients than other currently~     used methods. Three of four patients will undergo calcium scoring and the remaining patients~     will receive standard care.~   "
17462|NCT02828748|"~     Chronic intestinal inflammation characterizes inflammatory bowel diseases (IBD), which~     consist mainly of Crohn's disease and ulcerative colitis. The exact etiology is unknown for~     both diseases and therapeutic attempts aimed at down-regulating intestinal inflammation use~     both mediator-specific and nonspecific immune suppression. These attempts cause considerable~     side effects. Also, IBD patients are different in their genetic background and pathology. It~     was previously shown that products based on marijuana (Cannabis sativa) produce beneficial~     effects for patients with IBD, and medical cannabis-based products were formerly proven to~     have anti-inflammatory activity in laboratory experiments and in clinical tests. However, it~     is unknown how C. sativa-based medical products exert their effect in IBD and additional~     research and development should be done. One issue to be resolved in the process of~     medicalization of C. sativa is the base for the differences in patient response to different~     C. sativa lines, in order to fine-tune C. sativa -based treatment to IBD patients.~      For this aim of fine-tuning C. sativa -based treatment to IBD patients, we characterized the~     chemical composition of different C. sativa lines and their anti-inflammatory activities on~     colon cells lines. Extracts of C. sativa lines were prepared using various methods and~     cannabinoids and terpenoids profile was determined by chemical analysis. We found that~     different compounds have different effects on inflamed colon cell lines, leading to changes~     in interleukin secretion, inflammation markers and gene expression in the treated colon~     cells. In addition, we have developed a unique system relevant for personalized medicine in~     IBD. This system allows a patient-specific determination of the effect of C. sativa -based~     treatment. Following, clinical tests will be conducted aiming to develop cannabis-based~     products from different C. sativa lines, with anti-inflammatory activity that is effective~     and optimized for the different IBD patients.~   "
17463|NCT02828735|"~     The purpose of the study is to evaluate the use of subcutaneous impedance measured with an~     implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate~     monitor.~   "
17464|NCT02828722|"~     The purpose of this study is to determine whether the environmental simulation of daytime~     and night time alternation as well as by the nutrition protocol corresponding to the daily~     rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit~     (ICU) requiring mechanical ventilation.~   "
17476|NCT02828566|"~     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard~     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in~     the paediatric population. The aim is to assess if IN administration is equivalent to the~     current standard of care, IV. The population to be studied is children 4-17 years of age who~     require a simple orthopaedic reduction. Following a double dummy approach to overcome the~     difficulty in masking interventions, each participant will receive both IV and IN~     interventions, only one of which will be the real drug. Procedural sedation and analgesia~     (PSA) will be assessed using the Dartmouth Operative Conditions Scale (DOCS).~   "
17767|NCT02824783|"~     The aim of the study is to investigate the quality of life and satisfaction of patient who~     underwent colorectal surgery using an enhanced recovery protocol when back home.~      In this retrospective study patients will be telephoned and asked to answer a questionnaire.~   "
17465|NCT02828709|"~     Irreversible Electroporation (IRE) is an emerging technique delivering electrical pulses to~     ablate tissue, with the theoretical advantage to overcome the main shortcomings of~     conventional thermal ablation. Recent short-term research showed that IRE for the ablation~     of renal masses is a safe and feasible treatment option. In an ablate and resect design,~     histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE targeted~     renal tumors were completely covered by ablation zone. In order to develop a validated~     long-term IRE follow-up study, it is essential to obtain clinical confirmation of the~     efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges~     verification of a suitable imaging modality. The objectives of this study are the clinical~     efficacy and safety of IRE ablation of renal masses and to evaluate the use of~     cross-sectional imaging modalities in the follow-up after IRE in renal tumours.~      This is a prospective, human, in-vivo study among 20 patients presenting with solid~     enhancing SRM on cross sectional imaging suspect for renal cell carcinoma (RCC).~     Preoperatively, imaging is required through Magnetic Resonance Imaging (MRI),~     Contrast-enhanced ultrasound (CEUS) and contrast-enhanced Computed Tomography (CT).~     Furthermore, serum creatinine levels and VAS scores are obtained. A biopsy of the SRM will~     be performed in preoperative setting. IRE ablation will be performed using CT-guidance and~     ablation success will be measured directly after the ablation through contrast-enhanced CT.~     Device related adverse events (AE) will be registered using the Common Terminology Criteria~     for Adverse Events (CTCAE) version 4.0 guideline. One week post ablation only CEUS and MRI~     will be performed to limit exposure to ionizing radiation. At 3 months, 6 months and 12~     months post ablation CEUS, MRI and CT will be performed. Additionally, at these time points~     serum creatinine levels and VAS scores will be obtained, and quality of life will be~     assessed through SF-36 questionnaires. Residual and recurrent disease will be assessed~     through tissue enhancement on cross sectional imaging.~   "
17466|NCT02828696|"~     This study evaluates the effectiveness of a minimally invasive treatment, consisting of~     partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of~     rehabilitation of advanced and generalized dental wear over a period of 5 years.~   "
17467|NCT02828683|"~     The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster)~     sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI),~     by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare~     metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.~   "
17468|NCT02828670|"~     T follicular helper lymphocytes are involved in the pathophysiology of autoimmune diseases.~     In humans, an increase in the proportion of circulating follicular helper T lymphocytes is~     observed in systemic lupus erythematous, Sjögren syndrome. No study has yet been conducted~     in patients with autoimmune hemolytic anemia. In another autoimmune cytopenia, immunological~     thrombocytopenia pathogenesis (ITP), the investigators showed for the first time an increase~     in circulating TFH and splenic TFH and their implication in the activation of autoreactive B~     lymphocytes.~      Hypothesis is that autoimmune hemolytic anemia is associated with an increase in the number~     and/of function of TFH, which thus participate in the hyperactivation of B lymphocytes.~      The demonstration that TFH are implicated in autoimmune hemolytic anemia will rapidly lead~     to the use of targeted therapies to inhibit these cells. These treatments are in the~     clinical phase of development in other autoimmune diseases.~      This study is interventional because of a lots of blood sample~   "
17469|NCT02828657|"~     A prospective, multicenter, open-label, post-approval study of the safety and effectiveness~     of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older)~     with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2~   "
17470|NCT02828644|"~     This is an exploratory study to assess potential maintenance of clinical benefit (cognition~     and symptoms) following 4 weeks of at-home digital therapy in ADHD children.~   "
17471|NCT02828631|"~     Videolaryngoscope provide better view of the larynx. This better view could improve the~     navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result~     in adult, one previous report using Glidescope in children did not show better performance~     than direct laryngoscope. The aim of this study is to compare the performance of McGrath,~     Pentax and Macintosh laryngoscope for nasotracheal intubation in children.~   "
17472|NCT02828618|"~     This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only,~     and Part 3 is a multinational trial.~      All patients with suspicion of advanced ovarian cancer are detected in the participating~     study centers in a pre-screening. The study centers will register all patients with~     suspected ovarian cancer in a screening log. After the patients have given informed consent,~     they can be enrolled in different parts of the study.~      TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En~     detail, this part of the trial will evaluate if one of two strategies of timing surgery~     within the therapeutic procedures may show any significant advances in terms of overall~     survival over the other.~   "
17473|NCT02828605|"~     The purpose of this study is to test a tablet-based application called VIP Transplant,~     devised to improve the recovery experience of patients that have recently had organ~     transplant surgery. The study will consist of two non-randomized arms: the first arm will~     consist of usual care and the second will be using the newly developed app for 21 days to~     replace their in-person visits. Using questionnaires and in-app usage metrics, the research~     team will track whether patients have a better medical outcome, greater patient satisfaction~     with care, and greater compliance rates as compared to patients who do not use VIP~     Transplant to manage their care.~   "
17474|NCT02828592|"~     Severe aplastic anemia is a rare and serious form of bone marrow failure related to an~     immune-mediated mechanism that results in severe pancytopenia and high risk for infections~     and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance~     of survival; however, a response rate with just immunosuppression for those patients lacking~     suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of~     patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3~     relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical~     donor for transplantation has good response rates and significantly lower rates of acute and~     chronic GVHD.~   "
17475|NCT02828579|"~     Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious~     diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only~     effective method of achieving weight loss in patients with morbid obesity.~      The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty~     liver disease in patients operated on due to morbid obesity.~   "
17477|NCT02828553|"~     There is an overwhelming amount of deconditioning that occurs during the hospitalization to~     a patient admitted with a primary diagnosis of congestive heart failure. The goals of this~     study are to determine if monitored activity and aggressive mobility provides improved~     outcomes in hospitalized heart failure patients.~   "
17478|NCT02828540|"~     To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic~     stroke~   "
17479|NCT02828527|"~     Background / Rationale at. The mild head injury.~      In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of~     mild head trauma. This is a pattern of frequent use of the health system. The reason for~     consultation, benign appearance, present a significant risk of complication. In 15 to 25% of~     the evolution of head injury is unfavorable. Disorders of attention, memory disorders,~     psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome,~     post-concussion syndrome.~      The post-concussion syndrome:~      It affects approximately 20,000 people per year in France. This is a common disease and most~     undervalued in the general population. diagnostic criteria post-concussional disorder~     according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than~     3 months after head injury. This syndrome is responsible for suffering, personal and~     professional sound and quality of life of patients. It is particularly debilitating in~     everyday life, and can have disastrous consequences on their family, social, cultural and~     professional. It gives rise to many financial implications with compensation requirements~     and expertise consultations.~      Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has~     been shown that screening and early treatment of post-concussion syndrome from the slight~     head injury prevents chronicity of symptoms.~   "
17480|NCT02828514|"~     The purpose of this study is to determine nasal resonance change after endoscopic endonasal~     transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.~   "
17481|NCT02828501|"~     Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain.~     However, the methods by which SMT exerts its effects are not well understood. The aim of~     this study is to assess potential changes in pain pressure threshold following both a~     cervical and lumbar spine manipulation in a single treatment session at sites local and~     diffuse to the site of manipulation application. This study will also attempt to determine~     if the order of the cervical and lumbar manipulation application impacts pain pressure~     threshold changes.~   "
17482|NCT02828488|"~     Fragility, geriatric concept recent identification is defined by simple physical indicators.~     The literature suggests that it is related to the risk of hospitalization, falls,~     institutionalization and death. Some studies have shown a link with heart disease, including~     heart failure. The link with the TIA (transient ischemic attack) has however never been~     studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA~     is unknown.~      Several questions need to be asked: Among older patients hospitalized for TIA, what~     proportion of those completing the criteria of frailty? In this same population, is there a~     correlation between fragility and scores ABCD2 score itself predictive of the risk of~     subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher~     risk of ischemic stroke (which could cause a strengthening of prevention measures)?~   "
17483|NCT02828475|"~     This is a pilot study of surgical patients whose postoperative care will be augmented with a~     personalized risk prediction platform (CALYPSO app).~   "
17484|NCT02828462|"~     The emergence of oral delivery in cancer therapeutics is expected to result in an increased~     need for better coordination between all treatment stakeholders, mainly to ensure adequate~     treatment delivery to the patient. There is significant interest in the nurse navigation~     program's potential to improve transitions of care by improving communication between~     treatment stakeholders and by providing personalized organizational assistance to patients.~     The use of health information technology is another strategy aimed at improving cancer care~     coordination that can be combined with the NN program to improve remote patient follow-up.~     However, the potential of these two strategies combined to improve oral treatment delivery~     is limited by a lack of rigorous evidence of actual impact.~      The investigators are conducting a large scale randomized controlled trial designed to~     assess the impact of a navigation program denoted CAPRI that is based on two Nurse~     Navigators and a web portal ensuring coordination between community and hospital as well as~     between patients and navigators, versus routine delivery of oral anticancer therapy. The~     primary research aim is to assess the impact of the program on treatment delivery for~     patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves~     a number of other outcomes, including toxic side effects, patient quality of life and~     patient experience . An economic evaluation adopting a societal perspective will be~     conducted, in order to estimate those health care resources' used. A parallel process~     evaluation will be conducted to describe implementation of the intervention~   "
17485|NCT02828449|"~     Therapeutic education is an effective way to support the prescription of oral chemotherapy~     in oncology. It aims to increase adherence to treatment, to better control the side effects~     and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes~     region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien~     Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education~     Program context of each of these institutions.~      The objective of this study is to evaluate the implementation of the intervention in the 3~     participating centers, over 1 year:~        1. Assess the achievement of the target population~        2. Evaluate the adaptation of intervention in context~        3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life,~          identification of interactions with the environment linked to the center,~          identification of unintended effects of the intervention.~        4. Assessing the sustainability of the intervention~   "
17486|NCT02828436|"~     To investigate the exercise blood pressure response during a lower-extremity dynamic~     exercise in postmenopausal women with hypertension and to determine if lumbar epidural~     spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and~     men with hypertension.~   "
17529|NCT02827877|"~     This pilot clinical trial studies how well copper Cu64-DOTA-trastuzumab positron emission~     tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab~     before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive~     breast cancer that has spread from where it started to nearby tissue or lymph nodes.~     Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a~     patient's response to trastuzumab and pertuzumab before surgery in patients with locally~     advanced HER2 positive breast cancer.~   "
18031|NCT02821338|"~     The objective of this study is to determine bioequivalence between two different~     formulations of lamotrigine extended release tablets (one reference product and one generic~     product) in a healthy adult population, following a single oral dose under fed conditions.~   "
17487|NCT02828423|"~     Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained~     defects may be limited, as EMD does not maintain a space itself. It has been proposed the~     use of combined therapy, using a bone graft in combination with EMD to avoid the collapse of~     the flap into the bony defect during the healing time. Therefore the aim of this study is to~     evaluate the clinical and radiological healing response of non-contained infrabony defects~     following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD~     alone.~      Methods: Fifty-two patients with at least 1 infrabony defect > 3mm in depth with a probing~     pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic~     parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the~     procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome~     was the change in clinical attachment level (CAL).~      Results: Analysis of the data demonstrated a statistically significant difference from~     baseline within each group (p<0.05), showing a difference in clinical and radiographic~     parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no~     statistically significant differences between treatment groups.~      Conclusions: It was concluded that the treatment of non-contained infrabony defects with~     EMD, with or without BC, resulted in statistically significant better results after 12~     months when compared to baseline measurements. In contrast, the combined approach did not~     result in a statistically significant improvement.~   "
17488|NCT02828410|"~     This is an open label trail to test the hypothesize that serum bovine immunoglobulin protein~     isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with~     an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic~     IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up~     to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads~     to improved nutritional status and QOL. A secondary objective is to evaluate SBI in the~     management of their disease, including impact on clinical symptoms.~   "
17489|NCT02828397|"~     Primary Objective: Determine blood concentrations of two formulations of REGN2222~      Secondary Objective: Assess safety and tolerability of REGN2222~   "
17490|NCT02828384|"~     Background:~      Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and~     urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols~     (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP~     diet in FI patients is needed.~      Aims:~        1. Compare the treatment response with a low FODMAP vs. psyllium based on number of~          episodes in patients with FI.~        2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on~          pre-specified clinical and quality of life endpoints.~      Methods:~      This is a prospective, randomized control trial of adults meeting the Rome III criteria for~     FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period~     and randomization, during which the severity of symptoms will be assessed and eligibility~     determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total~     of 20 patients will be recruited for each arm.~      The primary endpoint will be treatment response based on number of incontinence episodes. A~     treatment response is defined as a reduction in the number of FI episodes/week.~   "
17491|NCT02828371|"~     Verticalization was reported to improve the level of arousal and awareness in patients with~     severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the~     effectiveness of a very early stepping verticalization protocol on the functional and~     neurological outcome of patients affected by disorder of consciousness due to ABI.~      Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU~     on the third day after an ABI. They were randomized to undergo conventional physiotherapy~     alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table~     with robotic stepping device. Once stabilized, patients were transferred to a~     Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on~     the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).~   "
17492|NCT02828358|"~     This pilot trial studies the side effects of azacitidine and combination chemotherapy in~     infants with acute lymphoblastic leukemia and myeloid/lymphoid or mixed-lineage leukemia~     (MLL) gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone,~     daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase,~     hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin~     calcium, and thioguanine work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving more than one drug may kill more cancer cells.~   "
17493|NCT02828345|"~     This research trial studies the levels of a type of biomarker, circulating tumor cells~     (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological~     molecule found in blood, other body fluids, or tissues that is a sign of a normal or~     abnormal process, or of a condition or disease. A biomarker may be used to see how well the~     body responds to a treatment for a disease or condition. Studying samples of blood in the~     laboratory obtained before and after treatment from patients with melanoma may help doctors~     learn more about changes that occur in CTC levels and whether they may predict how well~     patients will respond to therapy.~   "
17494|NCT02828332|"~     Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD,~     but little is known about their determinant in a long-term perspective. The EpiTED cohort~     was set-up in order to understand the heterogeneity of developmental trajectories among~     children with a diagnosis of PDD and the role of clinical, biological and environmental~     factors in their adaptive outcome. It is one of the rare cohorts involving a long term~     prospective follow-up based on a large set of variables, and precise phenotypes of the~     entire autism spectrum.~   "
17495|NCT02828319|"~     To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213~     administration in patients with iron deficiency Anemia~   "
17554|NCT02827552|"~     This study aims to explore prospectively the distribution of individual radiosensitivity in~     the pediatric population and to determine the predictive power of individual~     radiosensitivity biomarkers from an immunofluorescence technique on primary dermal~     fibroblasts~   "
18303|NCT02817763|"~     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered~     parameters of connective tissue graft associated or not with partial resin composite (RC)~     for the treatment of gingival recession with NCCL, performed before the surgical procedure.~   "
17496|NCT02828306|"~     Patients with skull defects after craniotomy for example tumor resection, head trauma,~     stroke, need a reimplantation of the bone afterwards. For some circumstances, their own bone~     cannot be reimplanted due to infection, tumor infiltration, damage to the bone, or aseptic~     bone necrosis. In these cases a Patient Specific Implant (PSI) needs to be designed to fit~     into the patient`s skull defect.~      The design of the PSI is based on the preoperative CT-scan of the patient`s head with the~     skull defect, the imaging data set is uploaded and processed with IPlanNet software by~     BrainLab®. With the help of the software, a 3D model of a negative mould of the PSI is~     designed and printed. In the operation room, the PSI is fabricated under sterile conditions~     using the PSI mould. The design of the PSI mould with the help of IPlanNet is demanding and~     takes some few hours depending on the complexity of the case to be designed. In certain~     cases the accuracy of the fabricated PSI mould is not optimal, so that the surgeon~     intraoperatively has to adapt for the inaccuracy to achieve the best cosmetic and functional~     results at the expense of the operation duration, a known risk factor for postoperative~     wound infection and other perioperative complications.~      Therefore, the investigators have developed an automated computer-based algorithm for PSI~     design (CAPSID). With the help of this tool, an accurate PSI and its corresponding mould can~     be calculated and designed based on the preoperative CT scan of the patient within 5-15~     minutes and the corresponding mould can be printed. This step is automated and thus,~     independent of the neurosurgeons experience and skills in 3D processing software. The mould~     can be used for intraoperative fabrication of the implant under sterile conditions in the~     common way as described above. The possible advantages of the clinical establishment of this~     procedure would be a higher accuracy of the PSI compared to the conventional PSI fabrication~     method with better cosmetic results, lower costs and faster availability and production~     leading to shorter waiting time for the patient, and as a consequence of the higher accuracy~     leading to shorter operation time, with a reduction of risk of operative adverse events for~     the patient. Furthermore, the proof of practicability of this new method, could lead to new~     concepts in the field of Computer-based Patient Specific Implants in modern medicine in~     general.~   "
17497|NCT02828293|"~     The objective of this research project is to perform a comparative study on the in vivo~     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed~     Bearing TKA and the GMK UC Fixed Bearing TKA.~   "
17498|NCT02828280|"~     The direct objective of this study is to determine whether an experienced provider can more~     adequately and/or easily ventilate an anesthetized patient with the NuMask device as~     compared to traditional bag-valve-mask ventilation. The researchers believe that mean tidal~     volumes obtained by experienced providers when manually ventilating anesthetized patients~     with the NuMask device will be larger than when using the traditional bag-valve-mask.~   "
17499|NCT02828267|"~     A brief negotiational interview (BNI), administered in an Emergency Department setting for~     both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's~     alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-60~     minute) counseling session administered by non-addiction specialists based on the concepts~     of the FRAMES model of motivational interviewing. The investigators will conduct a pilot~     study to test the feasibility of the study protocols, acceptance of the intervention, and~     patient enrollment and retention rates, as we prepare for a fully powered randomized~     controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical~     Center (KCMC) Emergency Department.(ED)~   "
17500|NCT02828254|"~     The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in~     patients with cirrhosis due to hepatitis C by 12-month follow-up.~   "
17501|NCT02828241|"~     The purpose of this exploratory study is to assess the efficacy, safety and tolerability of~     DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.~   "
17502|NCT02828228|"~     1. Analyze the influence of vitamin D supplementation in obese children during weight-loss~          program on BMI, body composition and bone mineral density.~        2. Analyze the influence of vitamin D supplementation on the risk profile of~          obesity-related complications, namely impaired tolerance of glucose, insulin~          resistance, dyslipidemia and arterial hypertension, in obese children participating in~          weight-loss program.~        3. Analyze the prevalence of vitamin D deficiency among obese children.~        4. Analyze the risk factors of vitamin D deficiency in obese children (age, gender,~          pubertal status).~   "
17503|NCT02828215|"~     The objectives of this study include using the new technology of SS-OCT (swept source~     optical coherence tomography) to evaluate morphological abnormalities of the vitreous,~     retina and choroid and to assess the repeatability of retinal and choroidal thickness~     measurements in retinal disease using SS-OCT. A secondary objective is to use the new~     imaging modality of adaptive optics to directly visualize photoreceptor mosaics and~     microvasculature in eyes with retinal and choroidal disease.~   "
17504|NCT02828202|"~     Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of~     patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and~     multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011~     with anti-CTLA4, programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene,~     serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of~     advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological~     studies aiming to validate and identify new prognostic and predictive factors based upon~     clinico-epidemiological and histological data, genomic host and tumor alterations, tumor~     microenvironment characteristics, individual immunological profile and functional imaging.~     In the context of marketing of costly innovative molecules prospective collection of~     economic data on treatment and toxicity are required. Large biobanks collecting data from~     cohorts of advanced melanoma are mandatory for such projects.~      MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose~     objectives are :~        -  To provide an annual instrument panel with a descriptive and correlative analysis of~          patients with advanced melanoma in France including epidemiological, clinical and~          biological socio-economic characteristics~        -  to validate and identify new clinical, epidemiological, and biological prognostic~          factors such as genomic host and tumor alterations, tumor microenvironment~          characteristics, individual immunological profile in advanced melanoma.~        -  to evaluate the risk-benefit, the impact on treatment on patient quality of life, the~          management cost of patients treated with the validated and future treatments of~          metastatic melanoma. The project also aims to define predictive biomarkers of response~          and toxicity including pharmacogenetics and tumor genetics alterations, tumor~          microenvironment characteristics, individual immunological profile.~      Patients with unresectable stage III or stage IV melanoma will be enrolled prospectively for~     1 year with a 3 years follow-up (a total of 1000 patients will be enrolled) from 26 French~     centers A database of clinical monitoring of metastatic patients will be established and~     associated with a virtual tumor bank. This national database will be issued from the use of~     biological, clinical and imaging databases already available in the centers and optimized~     for this project; this database will also results from the interaction with the French~     national cancer institute (INCa) genotyping platform.~   "
17505|NCT02828189|"~     The main objective of this study is to determine whether the proposed program of therapeutic~     exercise is effective in improving fatigue and quality of life, more than the exercise~     unsupervised depending on their preferences, in women treated for breast cancer.~   "
17506|NCT02828176|"~     The aim of the study is to investigate the effect of different angles of lateral tilt on the~     maternal hemodynamics before and after spinal anesthesia~   "
17507|NCT02828163|"~     Comparing the effect of injecting autologous platelet rich plasma and triamcinolone~     acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.~   "
17555|NCT02827539|"~     The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy~     with the current standard of fluoroscopy. This research is being conducted to demonstrate~     the utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a~     spinal cord stimulator epidural array.~   "
17508|NCT02828150|"~     Although it is demonstrated that nutritional support can improve clinical outcomes, the~     literature shows that approximately 50% of cancer patients are not able to meet their~     estimated energy requirements. Recent clinical studies suggest that a supplementary support~     for parenteral nutrition (PN) could significantly help to improve the nutritional status of~     malnourished cancer patients.~      International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical~     cancer patients if enteral nutrition is not feasible and in patients affected by severe~     iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated~     for more than 7 days. However, there are no studies on the effects of integrative PN in~     hospitalized, malnourished, hypophagic, non-surgical cancer patients.~      Recent studies have reported on the validity of bioelectrical impedance vector analysis in~     monitoring the body composition of patients receiving nutritional support. Particularly,~     phase angle proved to be a superior prognostic marker than other nutritional screening~     tools.~   "
17509|NCT02828137|"~     The neutrophil-to-lymphocyte ratio (NLR) has been proven to be reliable inflammatory marker~     for atherosclerotic process and predictor for clinical outcomes in patients with various~     cardiovascular diseases. Recent study reported elevated NLR was associated with impaired~     myocardial perfusion in ST-segment elevation myocardial infarction (STEMI) patients. The~     investigators sought to determine whether NLR is associated with coronary microcirculation~     assessed by index of microcirculatory resistance (IMR) in STEMI patients who undergone~     primary percutaneous coronary intervention (PCI). A total of 123 patients with STEMI~     underwent successful primary PCI were consecutively enrolled. NLR at admission was~     calculated, and the patients were divided into three groups according to NLR tertiles. IMR~     was measured by intracoronary thermodilution-derived method immediately after index PCI.~   "
17510|NCT02828124|"~     A Study to Evaluate the Safety and Tolerability of BMS-986183 in Patients with Liver Cancer~   "
17511|NCT02828111|"~     This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to~     compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in~     comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational~     center (metasite) in the United States will participate in this study. Approximately 36~     subjects who meet the study entry criteria will be enrolled into one of four sequential~     cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or~     vehicle gel.~   "
17512|NCT02828098|"~     12 to 24 patients with aggressive solid tumors from whom biopsies can be obtained, will~     receive BO-112 through IT administration.~      Injected lesions must be palpable and biopsiable at the time of injection, and biopsied~     after 7-14 days. Patients will not receive an alternative therapy during the period~     comprising from first and second biopsy. BO-112 will be administered at a starting dose.~     Upon confirmation of the safety profile of the starting dose and evaluation of the~     pharmacokinetic (PK) profile, three additional dose levels are expected to be tested.~      During the course of the study, subjects will be examined for any side effects that may~     occur (safety and tolerability).~      Additionally this study will also study BO-112 biological activity, the innate and adaptive~     immune system response and signaling pathways, as well as signs of clinical relevance, will~     be studied.~   "
17513|NCT02828085|"~     Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade,~     recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and~     can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis~     is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to~     improve the diagnosis of this syndrome investigators have developed a strategy of systematic~     prescription of biological tests by kit. This prescription by 'kit' strategy proved its~     interest by comparison with an intuitive requirement of biological. In this study~     investigators want to improve the diagnostic causative of pericarditis by implementing a new~     diagnostic strategy. This new strategy includes (i) samples additional less invasive for the~     patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective~     diagnostic techniques: specific Polymerase Chain Reaction (PCR)~   "
17514|NCT02828072|"~     The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with~     anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac~     autonomic control in a population of patients with anxiety-depression disorders which will~     undergo a specific SKY treatment.~   "
17515|NCT02828059|"~     A medical approach that warrants continuous and reliable local administration of non-opioid~     analgesic drugs might substantially improve post-surgery pain management in CS, while~     decreasing the necessity of staff-dependent invasive procedures and the probability of~     untoward effects following systemic drug exposure. ReadyfusOR® is a formulation comprising a~     Ropivacain-loaded single-use pump which has been approved for regional application of the~     analgesic drug, also comprising obstetric interventions. There is, however, scarce~     scientific information on the efficacy and benefit of this anesthetic drug formulation for~     pain management following CS by means of continuous wound infiltration.~   "
17516|NCT02828046|"~     The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after~     single and multiple doses in healthy volunteers.~   "
17517|NCT02828033|"~     This study is an open label proof of concept study of rilonacept for patients with ANSHL~   "
17518|NCT02828020|"~     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50~     and 100 mg) compared to placebo for the acute treatment of a single migraine attack.~   "
17575|NCT02827279|"~     The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders,~     affecting nearly 1% of the general population. The disorder of social interaction has often~     been described as resulting from poor emotion recognition, or a bad perception of biological~     motion. However, the results of studies on these issues are very divergent. The PDD also~     been described as a disorder of emotion regulation, but few studies address the emotional~     feelings of individuals with ASD and their neuropsychological implications.~      The main objective is to study the effect of induced emotion in the children with ASD on his~     visual exploration strategies.~      This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy~     terms of the look in a group of children with ASD, in a context of emotional induction (joy,~     fear, sadness or anger) using of sound stimuli.~   "
17519|NCT02828007|"~     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease~     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive~     ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is~     blowing air through a mask. NIV provides patients with a bigger expansion of their lung when~     they are breathing. This better expansion helps patients to have more oxygen and less waste~     gas (or carbon dioxide) in their body.~      These improvements enhance survival and quality of life. In order to provide appropriate~     ventilation for each patient, the ventilator can generate different types of blowing:~        -  Continuous positive airway pressure (CPAP) which delivers a constant pressure to the~          mask~        -  Pressure support ventilation (PSV) which delivers a constant pressure to the mask and,~          on top of that, delivers more pressure when the patient begins to breathe in.~        -  Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to~          generate the flow when the patient begins to breathe in.~      These different types of blowing have consequences on patient comfort as well as on the~     improvement of their ventilation.~      To assess the improvement of the ventilation, the investigators currently use blood tests,~     however, these reflect overall output and may miss more subtle changes in breathing that~     could affect how patients feel.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV onto~     lung ventilation in real-time.~      The investigators hope to use the EIT technology to assess in real-time patients lung~     ventilation when they are using the NIV. The investigators hope that EIT will provide them~     with information on which type of blowing is more effective and more comfortable than the~     others.~   "
17520|NCT02827994|"~     This study compared the effectiveness of pain neurophysiology education and neck/shoulder~     exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).~   "
17521|NCT02827981|"~     Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of~     MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is~     characterized by a vertebral bone edema secondary to active discarthrose. Its prevalence is~     estimated at 6% of the general population and up to 40% of the CLBP according to studies.~     Following the discovery of this recent diagnostic entity, responsible for low back pain, the~     question of its management is debate in the medical community. Early studies demonstrate the~     effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest~     the contrary, infectious, incriminating a pathogenic role of certain bacteria such as~     Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment~     with prolonged antibiotic therapy. This study will aim to assess the effectiveness of~     intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work~     will be to assess these infiltrations in various subgroups such as patients with a previous~     surgery of the spine or a history of scoliosis or spondylolisthesis.~   "
17522|NCT02827968|"~     This is an open label, dose escalation study to evaluate the safety and tolerability of~     KN035 in advanced and metastatic solid tumor.~   "
17523|NCT02827955|"~     Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200~     implying that at least 300 000 peoples are concerned in France. Its frequency increase with~     age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that~     can be associated with head/voice tremor. ET induces a social impairment but also~     difficulties to perform any task requiring dexterity. With time, tremor can be so severe~     that every activity of daily living is impaired with loss of autonomy.~      Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the~     beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep~     Brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be~     proposed. However, in case of medical or surgical contra-indication, Gamma Knife (GK)~     radiosurgery thalamotomy can be an alternative option.~      Patients will be included with a minimum of 12 months after having the first thalamotomy~     (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in~     cognitive assessment, voice assessment and balance and postural assessment or~     neuroradiological abnormality.~      Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical~     assessment (tremor rating scale) impairment of activity of daily living, neuropsychological~     evaluation, voice assessment and balance and postural assessment.~      The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will~     be done.~      This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery~     thalamotomy in ET patients with severe impairment.~   "
17524|NCT02827942|"~     Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan~     20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg~     bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1~     week. Success or failure of eradication was determined by the 13C-urea breath test performed~     at 1 month after the therapy.~   "
17525|NCT02827929|"~     The objective of this study is to determine whether the systematic education on air way~     disease and inhalers in outpatient settings contributes to improve the quality of life.~      Education has been known to be effective for management of chronic airway disease. However,~     the real benefits remain unclear. An organized education on the chronic airway disease is~     directed by primary care physicians, and the investigators evaluate the effectiveness of the~     education.~   "
17526|NCT02827916|"~     Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer.~     However, the development of neuropathic pain under treatment limits its use. These are~     manifested by acute hyperesthesia / distal cold allodynia and chronic course of~     hypoesthesia.~      It is widely reported that these pains are consecutive to hyperexcitability of some~     ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological~     mechanisms of neurotoxicity are multifactorial and still imperfectly described.~      Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose~     challenge is to quantify / measure NAION and explained by a biochemical approach,~     specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study~     insofar design methodology relies heavily on techniques developed for LIPIDOXA study and~     that the expected results will be complementary to those of LIPIDOXA.~   "
17527|NCT02827903|"~     Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin~     or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia~   "
17528|NCT02827890|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     sitagliptin and lobeglitazone in healthy male volunteers.~   "
17576|NCT02827266|"~     This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia~     and quality of life in participants with diabetes and chronic renal failure and who are not~     receiving dialysis.~   "
18304|NCT02817750|"~     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of~     zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.~   "
17530|NCT02827864|"~     This project is designed to investigate the effects of combining tDCS and MT in patients~     with subacute and chronic stroke. This project is also designed to investigate the optimal~     application timing of tDCS in combination with MT in patients with subacute and chronic~     stroke. Patients with subacute and chronic stroke will be recruited and randomized into one~     of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT~     group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of~     MT followed by 30 minutes of functional task training. For the participants in the SEQ~     group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied~     concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS~     electrodes will be placed on the scalp without actual current output. The interventions will~     be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be~     assessed by blinded evaluators before, after, and 3 months post intervention. To study the~     possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON~     vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be~     performed. Additionally, the partial eta square (η2) will be calculated to determine the~     effect size of interest.~   "
17531|NCT02827851|"~     Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic~     digestion. SVF will be administered in a single dose intraarticularly 4 weeks after~     arthroscopic debridement. All patients will receive cell therapy.This is a single arm study~     with no control.~   "
17532|NCT02827838|"~     This pilot clinical trial studies how well durvalumab before surgery works in treating~     patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab,~     may interfere with the ability of tumor cells to grow and spread.~   "
17533|NCT02827825|"~     The aim of this study is to describe the population of patients admitted to the ICU in~     neurosurgery for stroke requiring secondary care in intensive care and their future.~   "
17534|NCT02827812|"~     Parkinson's disease (PD) is a chronic neurodegenerative disease due to the loss of~     dopaminergic neurons in the substantia nigra, leading to motor symptoms of tremor, rigidity,~     and bradykinesia, as well as an array of non-motor symptoms that affect cognition, sleep,~     behaviour, and the autonomic nervous system.~      Lifelong rehabilitation measures, along with medication treatment, are the major components~     of patient management. Physical exercises positively affect patients' quality of life (QOL)~     and their functional capacities. Poor adherence to rehabilitation, limited patient~     education, and access to specialized care can be barriers to treatment. A number of papers~     in fact report that telemedicine is an acceptable means of care delivery reduces travel~     burdens and may improve patient outcomes. However, most of these studies were not randomized~     or controlled and did not include nursing home patients, who may benefit the most from~     specialty care.~      Moreover, there is no evidence supporting the use of telerehabilitation for physical~     assessments of people with PD. For this reason investigators hypothesize that a home~     telerehabilitation system guiding patients in following their exercise program combined with~     a computerized decision-support tool monitoring patient performance, would be feasible for~     and acceptable to patients with PD and would improve functional status.~   "
17535|NCT02827799|"~     The purpose of this exploratory developmental study is to test the feasibility,~     acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I)~     among adults who have stable Heart Failure. Participants were randomized either to a~     treatment (CBT-I) or attention-control condition (heart failure self management education).~   "
17536|NCT02827786|"~     A single-centre, industry sponsored, proof-of-concept pilot study to assess the feasibility~     of Electromagnetic Acoustic Imaging (EMA) as an imaging platform in the visualization of~     hepatic tumours.~   "
17537|NCT02827773|"~     The aim of this research project is to compare the use of Talking Pill Bottles to usual~     care in patients who have low functional health literacy and who purchase medications for~     primary hypertension at a retail pharmacy with regard to:~        1. feasibility of the procedures,~        2. utility of the equipment,~        3. medication adherence,~        4. self efficacy in medication self management, and~        5. blood pressure control.~   "
17538|NCT02827760|"~     The composition and metabolism of human gut microbiota play crucial roles in health.~     Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine~     having not only the highest density of microbes in terms of bacterial cells per gram but~     also the most metabolically active microbial community. Genetics, mode of birth, infant~     feeding patterns, antibiotic usage, sanitary living conditions and long term dietary habits~     contribute towards shaping the composition of the gut microbiome. Diet clearly has a major~     impact on variation in the gut microbiota composition, and this can be detected in faecal~     samples after only a few days. The bacterial metabolism of dietary components produces much~     chemical diversity in the large intestine with protective or detrimental effects on disease~     development.~      Dietary protein levels are relatively high in western European populations, up to 103g/d, as~     reported by Food and Agriculture Organization. This may result in high levels, entering the~     large gut where it can become a substrate for proteolytic bacteria. Protein specifically can~     provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be~     detrimental. Protein intake from the diet might not be the only source of microbial~     proteolysis; the human body also secretes considerable amounts of protein into the digestive~     lumen which can potentially be used by the microflora. On the contrary, end products of~     carbohydrate metabolism can be positive for health. In this context, prebiotics are~     carbohydrates that are resistant to digestion and can become available for bacteria in the~     colon to produce short chain fatty acids and inhibit the production of harmful metabolites.~     A switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis~     therefore has positive capacity through the production of more benign metabolites.~      Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting~     bacteria only. Given the high intake levels of protein in Western populations, they may be~     useful to modulate the composition/activity of the microbial gut ecology for improved~     health.~      Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their~     administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These~     microorganisms are involved in the reduction of intestinal endotoxin concentration, improve~     glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy~     individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake.~      The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on~     the negative consequences of colonic fermentation in individuals consuming high protein~     diets. The hypothesis to be tested is that their action promotes carbohydrate degrading~     bacteria at the expense of protein utilisers.~   "
17577|NCT02827253|"~     The purpose of this study is to describe brain´s morphological changes induced by chronic~     kidney disease (CKD) in advanced stages (stages 4 and 5 defined by KDOQI guidelines) and~     also by haemodialysis using MRI.~      Based on the hypothesis that hypotension may cause damage in some organs including brain the~     investigators study if intradialytic hypotension (IDH) causes any type of changes in gray~     and white matter of the brain.~   "
18051|NCT02821052|"~     This trial is conducted in Asia. The aim of this Non-interventional study is to investigate~     the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in~     Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical~     practice conditions.~   "
17539|NCT02827747|"~     Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural~     changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus~     is 1:2000 in the general population. Oxidative stress has been thought to have a major~     effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in~     metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells~     undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic~     effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and~     E are important antioxidants in the human body. To this date, the role of systemic~     antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it~     has yet to be established as to whether there is a correlation between serum antioxidant~     levels, and the severity of disease in the Keratoconus patient. The investigators propose to~     investigate the plasma levels of antioxidants in relation to disease severity. The~     investigators will also investigate the role of antioxidant supplementation—consisting of~     parenteral Glutathione (GSH), and Vitamins A, C and E—in delaying the disease progression in~     Keratoconus.~   "
17540|NCT02827734|"~     Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges~     set by the complex pathophysiology of this heterogenous group. The investigators therefore~     aimed to evaluate novel or not widely used diagnostic approaches for the detection and~     therapeutic monitoring of patients with various ILDs.~   "
17541|NCT02827721|"~     Current guideline-based criteria defining COPD do not meet the challenges set by the complex~     pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not~     widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.~   "
17542|NCT02827708|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and~     safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate~     renal impairment.~   "
17543|NCT02827695|"~     Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject~     as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled~     hypertension will be enrolled into a screening phase to measure medication non-adherence.~     Each subject will use an electronic pill tray for 1 month without any reminder functions~     activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK~     or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and~     will receive attention control texts with healthy lifestyle information. SMASK will have the~     reminder functions of the electronic pill tray activated and will receive a Bluetooth blood~     pressure monitor and an app to collect the data and send to researchers.~   "
17544|NCT02827682|"~     The morbidity of colorectal cancer and the surgery number among elderly is growing. The~     investigators need to provide more advanced and specific monitoring technology for these~     patients. Index of consciousness (IoC) monitor is now widely used among endoscopy,~     cholecystectomy and other common clinical applications. The investigators goal is to verify~     whether using IoC monitor could help to improve the postoperative recovery after colorectal~     surgery.~   "
17545|NCT02827669|"~     The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a~     12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One~     Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2~     diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch~     in combination with the One Drop app and Experts program, and assess whether this group is~     more engaged or experiences a different impact as compared to participants who utilized the~     One Drop app and Experts program only.~   "
17546|NCT02827656|"~     The purpose of this study is to compare two luteal support protocols in In vitro~     fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome~     (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation~     triggering is as good as low dose hCG on day 3 post triggering..~   "
17547|NCT02827643|"~     The purpose of this study is to determine whether calcium and vitamin D supplement can~     attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil~     fumarate.~   "
17548|NCT02827630|"~     The purpose of this study was to evaluate the efficacy of a new digital health offering,~     Proteus Discover to lower blood pressure and glycated hemoglobin in patients with~     uncontrolled hypertension and type 2 diabetes.~   "
17549|NCT02827617|"~     The general aim of the project is the identification of dynamic molecular markers that can~     help the early and real time prediction of sustained benefit or no benefit from ibrutinib~     treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess~     whether clearance of TP53 mutated clones translates into a predictive biomarker of long term~     benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a~     sensitive tool that can early and dynamically inform on the development of ibrutinib~     resistant mutations in CLL.~   "
17550|NCT02827604|"~     This prospective, clinical, observational study compares preoperative and intraoperative~     sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean~     section.~      It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and~     transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.~   "
17551|NCT02827591|"~     This prospective, clinical, observational trial compares the measured value with~     quantitative ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value~     with quantitative ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the~     experimental measurement done in vitro (postoperatively) of lower uterine segment of women~     who underwent second cesarean section.~   "
17552|NCT02827578|"~     Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding~     symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a~     randomized, double blinded, parallel design, active controlled, multi-center, phase 3~     clinical trial~   "
17553|NCT02827565|"~     The objective of this study is to optimize the search by next-generation sequencing (NGS)~     mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic~     profiles obtained with those from tumors embedded in paraffin~   "
18331|NCT02817399|"~     The purpose of this study is to examine the short term effect of functional electrical~     stimulation treatment versus neuro-muscular electrical stimulation on gait quality for~     patient after anterior cruciate ligament reconstruction.~   "
17556|NCT02827526|"~     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain~     during the first 2-3 days following the operative procedure. Several factors contribute to~     postoperative pain in this patient population. Many patients present to surgery dependent on~     relatively high doses of oral opioids; this daily administration leads to tolerance to the~     effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain~     worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of~     the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which~     leads to fluctuations in levels of pain control (patients have to push a button to deliver~     pain medication when they begin to feel discomfort). Recent data suggest that the use of a~     long-acting opioid like methadone in the operating room, which provides analgesia for 24-36~     hours, may improve pain control after spinal fusion surgery. However, other pain treatment~     modalities are required in this patient population. Studies have demonstrated that ketamine,~     a drug that prevents pain by a mechanism different from opioids, is effective in reducing~     pain medication requirements when given in the perioperative period. Small-dose infusions~     not only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In~     particular, the combination of methadone and ketamine may be especially effective in~     controlling pain in patients following major operations. The aim of this randomized clinical~     trial is to examine the effect of a low-dose perioperative infusion of ketamine, when given~     with methadone in the operating room, on postoperative pain medication requirements, pain~     scores, and clinical recovery characteristics after spinal fusion surgery.~   "
17557|NCT02827513|"~     The purpose of this study is to investigate the safety, tolerance, food effect,~     pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended~     release (XR) formulations of Centanafadine (CTN) in Young Healthy participants.~   "
17558|NCT02827500|"~     The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of~     approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of <35%~     and heart-rate >70 beats per minute (bpm) who are being discharged from the hospital~     following stabilization from acute heart failure (HF) and will be randomized to a treatment~     strategy of predischarge initiation of ivabradine or usual care.~      All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart~     rate and systolic blood pressure will be assessed at this clinical visit. For participants~     randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart~     rate may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants~     randomized to usual care, ivabradine may be initiated at the provider's discretion. All~     participants will have a second follow-up study visit 6 weeks (42 +/- 14 days)~     post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will~     be assessed. For participants already taking ivabradine in either treatment group, the heart~     rate may again be used to adjust the dose of ivabradine. For participants not yet receiving~     ivabradine, it may be initiated at the provider's discretion. All participants will receive~     a 90 (+/-7) day post-discharge phone call by site to assess for event status and~     tolerability of ivabradine. All participants will have a final study visit at 180 (+/-14)~     days post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City~     Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending~     physician may initiate ivabradine per usual care clinical practice.~      The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment~     strategy of initiation of ivabradine prior to discharge for a hospitalization for acute HF~     will be associated with a greater proportion of participants using ivabradine at 180 days.~     Secondary objectives are to assess the impact of predischarge initiation of ivabradine~     on:Heart Rate (Percent change in heart rate from baseline to 180 days and Median heart rate~     at 180 days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ)~     and Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of~     predischarge initiation of ivabradine on other assessments of evidence-based implementation~     of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on~     whether or not indication status was retained and whether or not an ivabradine prescription~     was provided. Tolerability of ivabradine and adverse events during study follow-up.~   "
17559|NCT02827487|"~     Two hundred and ten women requesting IUD insertion will be randomly divided into three equal~     groups. To ensure blinding the double dummy technique will be used in which group 1 will~     receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo~     similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in~     addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to~     Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour~     before the procedure.~      After insertion of the IUD the women's pain perception will be assessed using a visual~     analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10~     corresponding to the worst possible pain.~   "
17560|NCT02827474|"~     The purpose of this study is to determine aspects of abortion care most important to the~     patient in creating a high quality abortion experience, to investigate patients'~     expectations of abortion care, and to explore provider perceptions of patients' abortion~     experiences and assess concordance with patients' perspectives.~   "
17561|NCT02827461|"~     The purpose of this study is to understand the hereditability of sleep homeostasis, i.e.,~     drive for sleep by looking at monozygotic and dizygotic twins.~   "
17562|NCT02827448|"~     The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive~     laboratory test performed on urine, predicts loss of kidney function in patients that have~     had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart~     (TAH) implanted.~   "
17563|NCT02827435|"~     Reperfusion of renal graft in kidney transplantation can change the~     pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of~     urine output during surgery may change the PKPD parameters of the drugs, including~     elimination rate. The goal of this study is to characterize the PKPD model of rocuronium~     during kidney transplantation and establish a basis for adequate dosage of rocuronium in~     kidney transplantation.~      Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated.~     Furthermore, the factors related to the changes will be assessed. Adjusting the infusion~     rate according to the step of kidney transplantation will lead to stable muscle relaxation~     and fast recovery.~   "
17564|NCT02827422|"~     Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard~     care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of~     rewarming is still unknown. The objective of this project is to improve the outcomes for~     patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic~     hypothermia established from the analysis of multicenter registry data.~   "
17565|NCT02827409|"~     To determine whether performing extended delayed cord clamping in term neonates that require~     resuscitation improves early transition as compared to short-delayed cord clamping.~   "
17578|NCT02827240|"~     ZEST is a cluster-randomized trial designed to determine whether HIV self-tests are~     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers~     in Zambian transit towns. This study will determine whether directly giving participants an~     HIV self-test or giving them a coupon to collect a test at a drug store or clinic improves~     outcomes compared to standard of care.~   "
17579|NCT02827227|"~     The objective was to identify factors associated with the normalization of the CD4/CD8 ratio~     (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined~     antiretroviral therapy (cART).~   "
17566|NCT02827396|"~     Background: It is asserted that 85% of disabled children live in resource poor countries~     with few available disability services. Measurements have shown an increase in disability~     prevalence from 2% to 4% over the past three decades in Malawi. A recent prevalence study in~     Mzuzu city, found 19.7% disability prevalence with associated social and psychological~     burden of care; marriage disruptions and divorces among parents of disabled children due to~     stigma and cultural misconceptions about disability.~      Studies have shown a link between parenting children with intellectual disabilities and~     parental psychological health problems and overall Quality of life. However, with~     interventions, these negative impacts are not as severe as once thought.~      Research Objectives: This study aims to design a Malawi specific Psychosocial Training~     Intervention for parents with intellectually disabled children and assess the impact of the~     Intervention in reducing psychological distress among these parents in Malawi.~      Methodology: This study will use mixed methods design. It will employ an explanatory~     sequential design, where by qualitative data collection and analysis builds to quantitative~     data collection and analysis; and final interpretation.~      The study will be conducted within catchment areas of two disability organisations that are~     operating in Mzuzu and Lilongwe.~      On sample size for the quantitative part, calculation using 5% level of statistical~     significance, power of 90% and effect size of 0.4 [effect size found in recent meta-analysis~     for similar intervention, gives 81 participants in each arm of the intervention.~     Questionnaire with social-demographic data in section one; and Self-Reported Questionnaire~     will be administered at baseline, 6 & 12 months follow-up. Quantitative data will be coded~     on a computer, cleaned and analyzed using STATA. Mann-Whitney test will be used to measure~     the impact of the intervention. Qualitative data will be analysed using content analysis~     with the help of Nvivo.~      All ethical consideration will be followed to ensure that subjects are treated with respect;~     allow for their right to refuse participation in the study; and conducting interviews in~     privacy.~      Dissemination: Findings will be disseminated through Continous profesional development (CPD)~     sessions at the two clinic sites; Research Dissemination Conferences in Malawi and~     Sub-region; and three manuscripts submission for publication in peer reviewed journals.~   "
17567|NCT02827383|"~     This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate~     potential for effect of fractionalized bouts of stair climbing on glucose control in adults~     at risk for type 2 diabetes.~   "
17568|NCT02827370|"~     The purpose of the study is to determine if a targeted dietary change can enhance the effect~     of neo-adjuvant chemotherapy~   "
17569|NCT02827357|"~     This chart review describe the response to systemic chemotherapy of patients with non-small~     cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor~     receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of~     the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2~     mutation in order to inform the design and powering of future randomized controlled clinical~     trials of HER2-directed therapy.~   "
17570|NCT02827344|"~     Immunotherapy is probably, since the development of therapies targeting EGFR mutations or~     ALK rearrangement, the most attractive therapeutic perspective in the management of~     metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint~     PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous~     clinical trials with recently published positive results leading to the approval of one drug~     in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1~     (PD-L1) expression by tumor cells is strongly associated with the response to such molecules~     so that the participation in various clinical trials is currently reserved for patients~     expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or~     CT-guided) representing a considerable drag on the access to these treatments. Circulating~     tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and~     non-invasive access to the tumor. It has already been demonstrated that molecular~     characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate~     the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.~      Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell~     functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to~     test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated~     to the response to these drugs.~      The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1~     expression on CTC~   "
17571|NCT02827331|"~     The question of the inclusion of periods of interruptions and periods unobservable has been~     studied as part of medico-administrative databases. However, the specificity of the health~     insurance databases justify the realization of dedicated methodological research. A thorough~     knowledge of the purpose of these data, how they collect and restitution is an essential~     prerequisite to carry out this work.~      One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis~     of the comparison between the exposure groups. However, this traditional approach has the~     major drawback of neglecting the changing nature of drug exposure, and therefore fails to~     take into account any changes or interruptions doses. Approaches to take into account the~     time dependent variables were developed. These allow to take into account any interruptions.~     However, as part of study on health databases, sometimes we do not have the status in~     relation to the exhibition on the entire monitoring period. This is for example the case~     during hospitalization. The bias generated by the failure to take account of these periods~     (non measurable time bias) can be problematic when a long exposure and chronic disorders~     require hospitalization.~   "
17572|NCT02827318|"~     Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is~     complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for~     overconsumption, is characterized by reduced prefrontal cortex activity, which in turn~     directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and~     insulin levels. This double blind randomised controlled trial explores the influence of~     disinhibited eating and vagal tone (heart rate variability) on the postprandial response to~     GL and hunger.~   "
17573|NCT02827305|"~     This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the~     reduction of plaque and gingival inflammation. Patients were divided into three groups of~     which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and~     group 3 received gotukola mouthwash only.~   "
17574|NCT02827292|"~     This study evaluates the effect of per-operative music on the bio-molecular inflammatory~     response in laparoscopic surgery. Per-operative music intervention will be given to the test~     group via headphones while the control group will be applied headphones without any music~     (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and~     24 hours postoperatively along with the baseline levels measured preoperatively. The values~     will be compared between the test and control groups.~   "
17959|NCT02822287|"~     This is a 1-treatment arm, open label design. This 1-day study includes a screening on day~     of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if~     participants are eligible for dosing the same day). The study also includes a supervised~     dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.~   "
17580|NCT02827214|"~     Thoracolumbar (TL) burst fractures in neurologically intact patients account for~     approximately 45% of all TL spine injuries. Despite being common fractures, there is~     significant variability in treatment recommendations encompassing surgery and non-surgical~     treatment options. The controversy regarding optimal treatment for these injuries is fueled~     by several studies which suggest a potential benefit to surgical treatment in the realm of~     patient satisfaction, and the overall socio-economic burden of treatment while other studies~     demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study~     aims to perform a prospective cohort analysis investigating the clinical outcome of various~     treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A~     cost-effectiveness analysis will also be performed to identify costs and benefits of each~     treatment option. More specifically a sub-group analysis will be performed for this group of~     patients, which have equipoise in regards to patients treatment, as decided by a blinded~     review panel.~   "
17581|NCT02827201|"~     The main objective of this trial is to evaluate every 2 months alternating~     nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the~     progression of disease at 6 months.~   "
17582|NCT02827188|"~     The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is~     to develop a non-pharmacological intervention program for children with Attention Deficit~     Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention,~     hyperactivity, and impulsivity. The present study will investigate the validity, feasibility~     and efficacy of this novel intervention.~   "
17583|NCT02827175|"~     Annually about 10 to 15 million international travelers from Europe visit tropical~     countries. Returning from a journey, fever is the cardinal symptom of many infections. This~     is the second reason for consultation (23%) for return from a trip, after digestive~     disorders (42%). Urgent evaluation must always be proposed. Although that may be the~     manifestation of a benign disease, fever of return can also presage a rapidly progressive~     and lethal disease. In 50% of cases, patients return home, after treatment and disappearance~     of symptoms, though the microorganism responsible for the pathology is not able to be~     identified. The prescription of a series of systematic biological examinations in the form~     of a diagnostic kit has shown its relevance and its effectiveness in improving the~     etiological diagnosis of endocarditis and pericardites for optimal support. In this study we~     propose to assess the effectiveness of the systematic prescription of a diagnostic kit~     'fever of the traveler' to all patients hospitalized with a fever after returning from a~     trip. Ready to use kit brings together in a single bag (i) instructions for use, (ii) the~     tubes, bottles and jars for the etiological diagnosis of fever of the traveler in the usual~     support (iii) an additional blood tube for research of pathogens emerging.~      Primary:~      To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of~     travelers on the return.~      Hypothesis:~      Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the~     return through the development of a diagnostic kit.~   "
17584|NCT02827162|"~     Primary objectives:~        -  To assess how dengue vaccine efficacy varies across participant subgroups regarding~          polymorphism in human leukocyte antigen (HLA) alleles of interest.~        -  To assess the association between HLA alleles and, serotype-specific neutralization~          antibody titers and summary neutralization measure in the vaccine and placebo groups.~        -  To assess the association between the polymorphism in HLA alleles of interest and~          susceptibility to Dengue fever and Dengue Haemorrhagic fever.~      Secondary objectives:~        -  To assess whether dengue serotype-specific neutralizing antibody titers and associated~          summary neutralization measure at 28 days post-dose 3 are related to the rate of~          occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3~        -  To evaluate whether the dengue serotype-specific neutralizing antibody and associated~          summary neutralization measure at 28 days post-dose 3 are related to the level of~          vaccine efficacy against dengue viruses after post-dose 3.~   "
17585|NCT02827149|"~     Italian, retrospective, prospective, observational, multicentre, spontaneous,~     non-interventional, non-pharmacological The study aims to analyze in the national Italian~     experience~        1. The compatibility level selected by the Italian Transplant Centres using an high~          resolution HLA typing at the start of search process for hematopoietic stem cell~          transplantation from volunteer unrelated donor~        2. The transplant outcomes in terms of Overall Survival, Disease Free Survival, Relapse~          Rate and Transplant Related Mortality and the correlation with the level of HLA~          matching pairs of donor/recipient included in the Italian Bone Marrow Donor Registry~          and Promise registry.~        3. The possible identification of allelic mismatching combinations characterized by~          increased cross-reactivity associated with higher incidence of acute or chronic~          graft-versus-host disease .~        4. The possible identification of combinations of allelic mismatching characterized by~          higher permissiveness.~   "
17586|NCT02827136|"~     The primary purpose of this study is to investigate the effect of lidocaine patch on the~     shoulder pain score after end of surgery.~      The secondary purpose of this study is to investigate the effect of lidocaine patch on the~     total number of analgesic request on ward.~   "
17587|NCT02827123|"~     The primary purpose of this study is to investigate the effects of McGrath MAC~     videolaryngoscopy on the intubation time for orotracheal intubation in children.~      The secondary purpose of this study is to investigate the effects of McGrath MAC~     videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.~   "
17588|NCT02827110|"~     A semi-rigid cervical collar is recommended for immobilization of the cervical spine in~     patients with cervical spine injury. It has been suggested that a reduction in mouth opening~     is the major contributing factor to the deterioration in the glottic view obtained.~     Fiberoptic intubation is among the most versatile techniques for managing both the~     anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic~     bronchoscope with videolaryngoscope has been suggested to permit visual control of the~     passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is~     to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone~     and bronchoscope with pentax airwayscope.~   "
17589|NCT02827097|"~     The primary purpose of this study is to investigate the effect of rectus sheath block on~     abdominal pain score after robotic single port cholecystectomy.~      The secondary purpose of this study is to investigate the effect of rectus sheath block on~     fentanyl consumption during stay of recovery room after surgery.~   "
17590|NCT02827084|"~     The study aims to analyze the immediate effects and 72 hours after application of the~     Kinesio Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO)~     and vastus lateralis (VL), the isokinetic performance of the quadriceps and referred pain of~     subjects with PFPS. The volunteers will be randomly assigned to one of the three groups and~     perform one of the protocols: control - remain at rest; KT - application of Kinesio Taping~     with tension in the VMO region; placebo - application of Kinesio Taping without tension, in~     the same region. All volunteers will be submitted to the evaluation of pain intensity, the~     electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before~     the application of KT, immediately after the application of KT and after 72h of application.~     Average effect estimates (differences between groups) for all variables will be calculated~     using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).~   "
17591|NCT02827071|"~     The purpose of this study is to evaluate this AngioScan angiography software on patients~     with various retinal vascular disorders. The advanced OCT instrument is an FDA approved~     clinically used camera, but the AngioScan angiography software is not FDA approved.~     Investigators would like to know if this imaging device and software can improve the quality~     of images and visualization of imaged tissues and whether they are useful in the diagnosis~     and treatment of eye diseases. Images collected in this study may be compared to other~     images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).~   "
17592|NCT02827058|"~     The purpose of this study is to determine whether injection needle pen point type 'PP Gauge~     25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for~     healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.~   "
17593|NCT02827045|"~     Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania~     (maniac phase). Vestibular tests have been shown high sensibility and specificity as a~     biological marker for major depression. This exploratory investigation will measure and~     compare the vestibular activity of bipolar disorder patients during different phases ( 6~     depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).~   "
17594|NCT02827032|"~     To perform post-market surveillance and evaluate the performance of the MobiusHD System in~     subjects with primary resistant hypertension.~   "
17595|NCT02827019|"~     Motherhood Our Lady of Good Help is from the 2006 merger of three hospitals, St. Joseph, Our~     Lady of Good Help and Saint-Michel. She was transferred to a new building in the heart of~     Paris Saint-Joseph Hospital Group website in March 2011. The premises of the birth room are~     spacious and nice. All delivery rooms are supposed to welcome the mother and child when the~     birth goes smoothly. There is a resuscitation room (called Nursery) for newborns requiring~     medical care. But since the installation in the new building, we had the impression that a~     number of children born without pathology futures and with good adaptation at birth passed~     through this room for no apparent medical reason.~      We wanted to make an inventory of home practice healthy newborns in our maternity, evaluate~     the reasons for a possible separation and appreciate the feelings of mothers cope with this~     separation.~   "
17596|NCT02827006|"~     CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects~   "
17597|NCT02826993|"~     A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between~     5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other~     reasons. The current standard procedure is to refer the patient to the department of~     radiology for a CT-colonography. In some instances the radiology department can offer the~     investigation the next day, and thus in the same colon preparation. At other times they~     cannot, and the patient has to go through an second colon preparation for the colonography.~      A CCE procedure could be provided to the participants immediately after the failed~     colonoscopy and the investigation can be completed the next morning in the same bowel~     preparation without a visit to the radiology department.~   "
17598|NCT02826980|"~     Endometriosis is defined as the presence of endometriotic tissue outside the uterus. Its~     pathophysiology is still misunderstood today, but more and more work on this pathology are~     published. The clinical presentation is generally characterized by the existence of cyclical~     pelvic pain, with dysmenorrhea, dyspareunia, dysuria, dyschezia.~      But, there are a wide variety of symptoms, with different painful sites and different types~     of pain.~      The estimated prevalence of endometriosis is about 10% in women. But the impact of this~     disease on quality of life and its economic impact is estimated considerable. In a US study,~     the direct costs associated with endometriosis were estimated at US $ 2.801 per woman. Some~     studies have focused also to quantify work absenteeism associated with endometriosis.~      The etiology of endometriosis is based on the migration of endometrial fragments reaching~     the pelvis via the tubes and establishing themselves on other sites, thus creating non~     cyclical uterine pain. Catamenial pace of pain is suggestive of the diagnosis, but with~     time, the pain tends to be chronic rather than cyclical. The standard diagnosis is based on~     visualization and histological examination of the lesions.~      The wide variety of symptoms of endometriosis often leads to wandering and medical~     diagnostic delay. A better understanding of this disease by the medical community would~     allow better management of these patients. Currently, endometriosis remains a misunderstood~     disease by rheumatologists. However, the initial presentation may mimic rheumatologic~     symptoms; thus, rheumatologists may face this disease.~      The purpose of this study was to determine the prevalence and characteristics of~     manifestations of endometriosis in a cohort of patients with a recent diagnosis of~     endometriosis established. Secondly, it may well be possible to establish a list of symptoms~     and signs suggestive of endometriosis for the rheumatologist, allowing to contact a~     specialized consultant gynecologist some patients by mistake in rheumatology.~   "
17599|NCT02826967|"~     This study will allow investigators to determine whether colonic irrigation may allow for a~     non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could~     lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus~     increased cancer prevention and early detection.~   "
17608|NCT02826850|"~     This project is one of four components of a thematic project that aims to evaluate the use~     of ultrasound in regional and infiltration blocks, called Use of ultrasound in regional~     blocks and infiltration for the treatment of acute and chronic pain.~      It aims to evaluate quantitatively and qualitatively the knee pain control in patients with~     osteoarthritis after neurotomy by saphenous nerve radiofrequency guided by ultrasound ,~     compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy .~      Differences between total consumption of analgesics, side effects of medications , impact on~     quality of life and functional capacity in patients undergoing saphenous nerve neurotomy by~     radiofrequency guided by ultrasound compared to neurotomy by radiofrequency of genicular~     nerves guided by fluoroscopy, will also be evaluated.~   "
17609|NCT02826837|"~     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of~     LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced~     Colorectal Cancer~   "
17960|NCT02822274|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17600|NCT02826954|"~     The study is based on the theory of a unified airway that considers the nose and paranasal~     sinuses together with lower airways as one integrated unit. The upper and lower respiratory~     tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes~     in one portion of the airway, can provoke similar changes throughout the airway. This is~     well documented in asthmatic patients but documented poorly in patients suffering from~     chronic obstructive lung disease (COPD).~      COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal~     involvement has been found to directly affect the lower airway, sinonasal disease is~     under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger~     project where the goal is to gain knowledge supporting the theory of a unified airway in~     patients with COPD.~      Here sinonasal, pulmonary and generic health related quality of life will be studied in a~     group of patients with COPD versus a control group. The severity of nasal airway obstruction~     will be linked to the the severity of pulmonary airway obstruction. Assessment of~     pathological changes in the nose with nasal endoscopy, as well as performing a nasal~     cytological brushing for the identification of nasal inflammatory responses in the nose,~     will be conducted in both the control and study group.~   "
17601|NCT02826941|"~     This study was a multicenter, randomized, controlled pilot trial of moderate systemic~     hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal~     encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.~   "
17602|NCT02826928|"~     Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the~     diagnosis and follow-up of patients with small-intestine neuroendocrine tumors. Although~     this marker has good specificity, its sensitivity is moderate and its dosage is~     constraining, since it requires urine collection over 2-3 days and specific diet.~     Preliminary data suggested that overnight 5HIAA value may be representative of 24-hour 5HIAA~     value, and that plasma 5HIAA dosage could be a valuable alternative to urine 5HIAA dosage.~     The main objective of this study is to compare sensitivity and specificity of overnight~     5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine~     neuroendocrine tumors.~   "
17603|NCT02826915|"~     Epilepsy in children is a major public health issue. It is the first neurological disease of~     the child. The specific incidence of epilepsy rates were highest during the first year of~     life, between 75,105 and 250,105 hab.an hab. year and remain high in the age group between 0~     and 10 years. Epilepsies predictions are varied. They can be spontaneously benign, drug-,~     chemically dependent or drug-resistant. These, refractory epilepsies, represent 20% of~     epilepsy as a child and adolescent than adult is about 1200 children and 1200 adults~     Picardy. The validation of non-invasive investigative tools is becoming a necessity in the~     management of drug-resistant epilepsies especially when a surgical decision is envisaged.~     The aftermath (motor, cognitive, sensory) appear to rule early; but they are sometimes~     limited to learning deficits detected later in the school curriculum. The investigators know~     that defects in neuronal electrical activity (eg critical discharges) induce a metabolic~     response and conversely metabolic disturbances can cause abnormal electrical activity. It is~     therefore important to have tools to better characterize the interactions between these two~     mechanisms to better understand brain function in the brain during development and during~     pathological situations. The investigators lack quantitative criteria regarding the impact~     of crises on the metabolic activity and thus predictive criteria consequences of crises on~     brain function. The deleterious hazard must be considered at all ages in both structures to~     causing seizures than in those where the crisis spread. The functional characterization,~     electrical, metabolic and anatomic pathology of these networks is necessary and contributes~     to a better understanding of physiological and pathological brain function, and helps to~     define the most appropriate treatment strategy.~      About childhood epilepsy, analysis of the EEG allows in 75% of cases to find predictive~     patterns characteristic of becoming. However in 25% of cases, we lack predictive objective~     criteria. This highlights the importance of developing analysis tools for more accurate and~     efficient brain function and to improve the management and evaluation of the prognosis of~     these children.~   "
17604|NCT02826902|"~     The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the~     quality of recovery from surgery has been reported in several different types of operations.~     The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess~     the degree of recovery after anesthesia and surgery, and has been validated in previous~     studies. Limb lengthening surgery is unique in that it is usually purely cosmetic, and the~     patients are mostly young and healthy patients. The present study aims to compare the~     quality of recovery with the QoR-40 questionnaire, in patients undergoing bilateral limb~     lengthening surgery under general anesthesia with either TIVA with propofol or inhalational~     anesthesia with desflurane.~   "
17605|NCT02826889|"~     Appropriate fluid management is an important part of anesthesia in patients undergoing~     surgery, and several dynamic indices have been suggested to have high predictability for~     fluid responsiveness in patients receiving mechanical ventilation. Among various surgical~     positions, the prone position is known to cause unique physiologic and hemodynamic changes~     and affect the predictability and cut-off values of dynamic indices for fluid~     responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected~     flow time were able to predict fluid responsiveness with relatively high accuracy in~     patients undergoing spine surgery in the prone position using a Wilson frame. However, the~     Jackson frame is known to have less effects on the cardiovascular system compared to the~     Wilson frame, and therefore may be physiologically more appropriate in patients undergoing~     surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can~     be monitored non-invasively in patients under mechanical ventilation. The present study aims~     evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid~     responsiveness in the supine and prone positions in patients undergoing posterior lumbar~     spinal fusion using the Jackson table.~   "
17606|NCT02826876|"~     Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use~     of narcotic drugs.~   "
17607|NCT02826863|"~     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the~     efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric~     and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be~     randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All~     subjects will be titrated to their randomized dose over a 14-day Titration Period. Following~     titration, subjects will continue treatment at their randomly assigned dose over a 12-week~     Maintenance Period. Total treatment time from the beginning of the Titration Period through~     the end of the Maintenance Period is 14 weeks.~   "
17620|NCT02826694|"~     The NC NEXUS research study is exploring the utility of next generation sequencing in~     newborn screening and parental decision making. The National Institutes of Health (NICHD and~     NHGRI) are co-funding this study under a single U-19.~   "
17961|NCT02822261|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17962|NCT02822248|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17610|NCT02826824|"~     The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the~     general population. This malformation is mostly diagnosed prenatally by ultrasound, usually~     at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.~      Several studies in recent years have helped to define the determinants of prognosis for the~     unborn child suffers from agenesis of the corpus callosum, whether total or partial. These,~     mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no~     other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning~     or viral seroconversion when pregnancy) is associated with favorable developments in terms~     of psychomotor development in 80% of cases Similar results were also found in prospective~     studies, while the associated nature of the defect seems most heavily encumber the prognosis~     as other malformation or syndrome associated with agenesis of the corpus callosum Although~     these recent data have already significantly influence prenatal counseling and outcome of~     pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis~     of the corpus callosum are still valid.~   "
17611|NCT02826811|"~     BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.~      In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is~     the main strategy that has proven effective in reducing the risk of BKVN. However, it~     exposes a transplant rejection risk estimated between 4 and 14% according to studies.~      Despite the pre-emptive reduction of immunosuppression, a significant number of patients~     continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's~     therefore urgent to develop new prognostic markers to identify earlier and more effectively~     patients with a higher risk of developing BKVN.~   "
17612|NCT02826798|"~     The purpose of this study is to compare the safety and effectiveness of four different doses~     of cytomegalovirus vaccines in healthy adults.~   "
17613|NCT02826785|"~     This study investigates the feasibility of a cognitive strategy training intervention for~     people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to~     complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire~     study duration per participant = 8 weeks). We will measure participant responsiveness and~     the overall efficiency of the intervention process.~   "
17614|NCT02826772|"~     This study is an open-label, non-randomized, dose escalation study in subjects with~     metastatic castrate resistant prostate cancer (mCRPC) who progressed both hormonal therapy~     (abiraterone or enzalutamide) and chemotherapy (docetaxol), or cannot tolerate either or~     both therapies.~      There will be two treatment phases:~        -  Phase I: Multiple dose escalations of GT0918 to establish safety and tolerability~        -  Phase II: Two identified dose levels from Phase I to further evaluate the safety,~          tolerability and antitumor activity of GT0918; subjects will be randomized into the 2~          treatment arms.~   "
17615|NCT02826759|"~     This study is designed to compare the serum sphingolipidomic analyses in healthy,~     pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups.~     As ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in~     inflammation, immunity and cancer, investigators proposed a hypothesis that~     sphingosine-1-phosphate and other sphingolipids may be associated with the progress of type~     2 diabetes. sphingolipids may be a biomarker for diabetes.~   "
17616|NCT02826746|"~     The primary purpose of this study is to investigate the effect of intravenous magnesium on~     postoperative throat pain after thyroidectomy.~      The secondary purpose of this study is to investigate the effect of intravenous magnesium on~     total dose of fentanyl in recovery room after thyroidectomy.~   "
17617|NCT02826733|"~     Many cognitive functions in human are based on asymmetric brain networks. For most adults,~     language is processed largely by the left hemisphere while other auditory treatments, such~     as voice recognition are rather based on the right hemisphere. Many studies helped to~     highlight the presence of anatomical and functional asymmetries both in the first months of~     life. What are the causes of these imbalances? How do they develop? Are they necessary for~     operation or for effective learning?~      The investigators would like in this work, in collaboration with applied mathematics team of~     Compiègne and INSERM team, to determine from which period the development of hemispheric~     dominance is set up for recognition of language and in which brain structure it occurs in~     preterm infants whose sound environment is usually very different from that of the fetus.~     The impact of this environment on brain development of infants and their early learning will~     be assessed.~   "
17618|NCT02826720|"~     The aim of present study is to investigate any relationship between hyperlipidemia and~     periodontal disease regarding the periodontal parameters and plasma lipid parameters, along~     with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol~     consumption.~      In this cross sectional study, a total of 160 individuals were divided into two groups based~     on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63).~     Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical~     attachment level (CAL) clinical parameters and community periodontal index of treatment~     needs (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density~     lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had~     been determined previously during individuals routine systemic examinations. Daily brushing~     habits and interdental cleaning together with dietary habits, alcohol consumption and~     physical activity levels were also recorded.~   "
17619|NCT02826707|"~     Despite physical activity (PA) being a valuable modality for promoting health, the evidence~     for effective PA intervention strategies for manual wheelchair (MWC) users is~     underdeveloped. Community-based programs and telephone-counselling interventions to increase~     PA among MWC users have had some success, but the uptake and adherence to these~     interventions remains low within this population. Community-based programs may not reach MWC~     users who live in rural areas and have issues with transportation, while health~     professionals may not optimally relate with MWC when providing telephone counselling.~     Although the PA needs of MWCs are not fully understood, there is reason to believe that~     including peers into intervention delivery may have benefits.~      A feasibility trial is critical and prudent prior to moving forwards with a large and~     expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention~     meets the needs of the target population; the right outcomes are measured; and that the~     intervention is feasible to administer.~      The objective of this study is to evaluate the feasibility of a Smartphone-delivered~     Peer-led Physical Activity Counselling (SPPAC) program for MWC users.~   "
17622|NCT02826668|"~     The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success~     rate and efficiency of labor epidural placement in the lateral position. The investigators~     hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield~     similar ultrasound results when done immediately prior to epidural placement. The~     investigators also hypothesize that the use of ultrasound with landmarks marked and depth to~     the epidural space estimated will facilitate epidural placement in terms of both efficiency~     (time required for placement) and efficacy of pain relief.~   "
17623|NCT02826655|"~     This is a feasibility study to assess the use of wide field adaptive optics optical~     coherence tomography (WF-AO-OCT) to determine whether there are structural differences in~     the peripheral retina in participants diagnosed with diabetic retinopathy compared to a~     healthy control group. This study being conducted under an abbreviated IDE. The~     investigators will analyze data using descriptive statistics. Risks related to light~     exposure will be managed by ensuring that the exposure to the WF-AO-OCT light source is well~     below maximum permissible limits for safe exposure.~   "
17624|NCT02826642|"~     The purpose of this study is to evaluate the safety, tolerability and potential efficacy of~     IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia~     (AML).~   "
17625|NCT02826629|"~     The investigators recently showed that visuomotor integration was significantly altered in~     schizophrenic patients during: (i) a grip force task (Teremetz et al., 2014), and (ii) a~     saccadic paradigm (oculomotor task)(Amado et al., 2008). Given this findings, the~     investigators propose a combined study of oculomotor and grip force control to better~     characterize the sensorimotor integration deficit. This approach may allow for~     identification of behavioural biomarkers of vulnerability to develop schizophrenia.~   "
17626|NCT02826616|"~     Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce~     the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect~     of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation~     myocardial infarction is not sure. this study aim to study the effect of Trimetazidine~     during the primary PCI on cardiac function in patients with ST-elevation myocardial~     infarction.~   "
17627|NCT02826603|"~     Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe~     plaque psoriasis.~   "
17628|NCT02826590|"~     This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the~     neck, neck muscle electromyography and sympathetic nervous system activity in people with~     neck pain.~   "
17629|NCT02826577|"~     No studies to date have examined the effects of pregnenolone on hypervigilance for social~     threat in individuals with perceived social isolation (PSI). We therefore are conducting a~     double-blind randomized research study combining three validated behavioral paradigms on~     social threat attention, perception of others, and emotion regulation with high-density~     electrical neuroimaging to probe the neuro-circuitry of social threat processing in young~     adults high in perceived social isolation two hours after the oral administration of 175mg~     pregnenolone (N = 24), 400mg of pregnenolone (N = 24), or placebo (N = 24). Such research~     has the potential to yield important insights into the neurobehavioral mechanisms of~     pregnenolone on hypervigilance for social threat and perception of others--- a first key~     step toward the development of adjunctive pregnenolone therapy in individuals with PSI.~   "
17630|NCT02826564|"~     The goal of the proposed research project is to assess the safety (dose limiting toxicity,~     DLT) of the combination of pembrolizumab and high-dose stereotactic body radiotherapy (SBRT)~     in patients with metastatic urothelial cancer. Both the SBRT dose and pembrolizumab dose~     will be fixed, but the timing of the combination will be varied. Secondary objectives~     include response rates, local control, progression-free survival (PFS) and overall survival~     (OS). Exploratory endpoints include immunologic responses and response rates in PD-L1- TIL-~     tumors. The combination sequence with the most promising response rates and the best safety~     profile will be selected to continue in a Phase II trial.~   "
17631|NCT02826551|"~     Post-operative pain control following elective anterior cruciate ligament reconstruction~     continues to be a hurdle for orthopaedic surgeons. This obstacle becomes particularly~     problematic during the first 36 hours after the operation, when the patient is experiencing~     pain at its peak intensity. Good control of pain leads to better patient comfort, confidence~     to place weight on the operative limb and improved ability to perform critical exercises in~     this period to improve joint range of motion.~      A variety of anesthetic techniques have been employed to reduce pain including: cryotherapy,~     systemic analgesic and anti-inflammatory drugs, intrathecal, regional blockade of peripheral~     nerves and frequently intra-articular injections. Each technique has been studied at length~     with mixed but overall favorable results. However, in the authors' experience, after femoral~     nerve blockade, patients continue to complain of posterior knee pain in the Post-Anesthesia~     Care Unit (PACU) and peri-operative period. Intra-articular injections comprised of morphine~     and other Na-channel blocker analgesics may curb some of this pain by bathing the posterior~     capsule in anesthetic. However, there is still a large concern amongst orthopaedic surgeons~     about the potential harm these agents may have on the knee's healthy articular cartilage~     surfaces. The long term effects, including chondrolysis have been documented in the shoulder~     and while in the short term this effect is diminished there is still hesitation among~     surgeons to use this form of pain blockade.~      This has led the investigators to adapt a technique of isolated posterior capsular~     injections after total knee replacements from the joint arthroplasty literature, which has~     shown favorable results with low complication risk. The investigators plan to study the~     effectiveness of this technique during ACL reconstruction in an attempt to curb the amount~     of posterior knee pain and decrease the overall narcotic use postoperatively while limiting~     the exposure of the native cartilage to harmful agents.~   "
17632|NCT02826538|"~     Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with~     patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis~     fractures compared with the standard procedure of fracture fixation.~   "
17642|NCT02826408|"~     Palpitation is a common complaint. Patients frequently feel this symptom despite having~     normal rhythm during symptoms. I have seen many patients who improve significantly on~     treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of~     discomfort that subsequently starts the feeling of palpitation. On searching literature I~     found no study that investigated the effect of PPI's on palpitations. Therefore I propose a~     study where the investigators randomize people with palpitations with normal heart rate (no~     arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or~     placebo. The result will help to investigate if the improvement is true and if the results~     are positive this can provide a simple treatment for a common problem.~   "
17643|NCT02826395|"~     The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of~     our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient~     management in patients with prostate cancer.~   "
17633|NCT02826525|"~     This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose~     study conducted at a single site. The study plans to include up to approximately 46~     evaluable subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver~     disease (liver fat content > = 8%) on metformin monotherapy.~      Three initial cohorts are planned:~        -  Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo~        -  Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo~        -  Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the~          possibility to add additional subjects if drop-out rates are higher than expected~      Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may~     be included in the study.~      The primary objectives of this clinical trial are to investigate the safety and tolerability~     of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the~     effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp~     with tracer technique; and to assess the effect of AZD4076 on liver fat content using~     magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple~     dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to~     reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on~     24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin~     resistant (HOMA-IR) and Matsuda index.~   "
17634|NCT02826512|"~     Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be~     treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or~     patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a~     maximum of one prior line of treatment for incurable disease will be treated with Niraparib~     until disease progression~   "
17635|NCT02826499|"~     Pedicular screwing has become the gold standard for intervertebral fixation required in~     degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing~     methods exist.~      The free hand pedicular screwing requires a high learning curve and has, as a consequence, a~     high malposition rate.~      The placing of pedicular screws under fluoroscopic control is the most common technique as~     it is both reproducible and accessible. It is a two dimensional imaging technique. The~     profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and~     the direction of the screw in the sagittal plane. However, there is no real control of the~     direction of the pedicular screw in the horizontal or frontal plane. The screw malposition~     rate is less important than with the 'free hand' technique but remains none of the less~     significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the~     patient and the staff.~      New revolutionary techniques as the tridimensional navigation and the per-operatory~     tomodensitometry appeared in the last few years. The techniques give the best results when~     used concommitantly. The material has the advantage of being very precise. The pedicular~     screw malposition rate is minimal after a three-dimensional localisation. However, those~     systems require qualified staff and expose the patient and the nursing team to high~     radiation levels. The costs are higher and the surgery duration is globally longer. It is~     thus difficult to implement this technique in each belgian hospital.~      Finally, the Pediguard technique appeared on the market. It is a guide for the perforation~     of the pedicular channel, with a probe at its extremity. This probe allows a real time~     measurement of the electric conductivity of the tissues that are being crossed. The~     conductivity measure is translated in a sound signal. Because the cortical bone has a low~     conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a~     medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the~     event of a breach in the pedicular cortical, as blood and periost have a high~     conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard~     technique helps thus to anticipate a cortical effraction, by detecting the proximity of the~     cortical wall. It is efficient but remains relatively expensive.~      The main objective of this study is to determine the precision of the placing of pedicular~     screws, with and without Pediguard system, under fluoroscopy.~   "
17636|NCT02826486|"~     This study will assess the efficacy and safety of BL-8040 as a single agent and in~     combination with pembrolizumab (Keytruda®) in subjects with metastatic pancreatic~     adenocarcinoma.~   "
17637|NCT02826473|"~     Neurocognitive Disorder (NCD) affects over 116'000 people in Switzerland and is frequently~     unrecognized and underdiagnosed. Because missed and delayed diagnosis are associated with an~     increased burden of disease health Service Research has prompted a discussion about~     diagnostic guidelines and screening programs. Some argue that screening for NCD in primary~     care is the optimal strategy to increase recognition rates; others consider test protocols~     implemented into hospital admission assessments as more justified. There is no distinct~     recommendation due to a lack of empirical data on the benefits and harms of cognitive~     testing yet. This trial strives to fill this gap and provide information about the benefits,~     harms and the economic case of routine cognitive testing for neurocognitive disorder in high~     risk elective inpatients, in Switzerland.~      The investigators hypothesize that, cognitive tested patients, compared with patients not~     cognitive tested, will have higher health-related quality of life at 12months; and lower~     medical health care costs at 18months.~   "
17638|NCT02826460|"~     A retrospective chart review in which the information in the standard psychosocial~     evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and~     correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include~     rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication~     Level Variability Index). The researchers will evaluate the degree to which both single~     elements in the evaluation as well as a cumulative score derived by a structured review of~     the chart using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT)~     model can predict posttransplant outcomes.~   "
17639|NCT02826447|"~     This project is a prospective observational cohort study to quantify the risk of acquiring~     Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams~     University Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient~     trajectories within the hospital; and 2) assessing the ward-specific risk based on the type~     and number of procedures performed and the prevalence of HCV viremia in patients within each~     ward.~   "
17640|NCT02826434|"~     The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and~     Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or~     III Triple Negative Breast Cancer. This research study is studying the safety, tolerability,~     and immune response of these treatments.~      The names of the study interventions involved in this study are:~        -  PVX-410 Vaccine~        -  Durvalumab (MEDI4736)~   "
17641|NCT02826421|"~     The purpose of this study is to compare corneal incision size after IOL implantation with~     the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one~     manually loaded IOL delivery system).~   "
17644|NCT02826382|"~     A phase 0 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer~     and determination of human dosimetry.~   "
17963|NCT02822235|"~     The purpose of this study is to gather information regarding the population with moderate to~     severe inflammatory bowel disease (IBD), the burden of the disease, and understand their~     treatment patterns, particularly on the use of available biologic therapies.~   "
17645|NCT02826369|"~     Breast MRI is increasingly important in breast screening imaging. It is currently based on~     dynamic sequences after contrast injection whose temporal resolution must be less than 90~     seconds with dynamic acquisitions at different times.~      These curves profiles are designed to differentiate benign from malignant lesions. Recently,~     Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions;~     lesion enhancement curves over time were more accurate than the curves usually performed.~      It seems necessary to work on sequences having better temporal resolution without~     compromising however spatial resolution.~   "
17646|NCT02826356|"~     Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and~     angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these~     treatments is challenging because they are expensive and have short shelf lives making it~     illusory that all emergency department (ED) stock them. The aim of this retrospective study~     was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which~     step of the care, the specific treatment was administered. The second objective was to~     analyse the availability of these treatment in the area around Lyon, France and the factors~     that may influence it.~   "
17647|NCT02826343|"~     First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic~     resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the~     University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed~     and optimized for the equipment at UVA. These sequences will need to be evaluated in healthy~     adults for comparison with results obtained and in adults with lung diseases to optimize the~     sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to~     be optimized for the parameters of a human MR coil and the gas exchange characteristics in~     healthy and diseased lungs.~      Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to~     monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting~     beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of~     the current COPD therapeutics. The investigators will characterize the functional changes of~     the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment~     after a three-month trial. Also the investigators will compare corresponding results~     obtained by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based~     dynamic contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed~     tomography (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The~     investigators anticipate that the results from this project will greatly improve the~     investigators understanding of the lung functional responses of COPD subjects to current~     therapeutics. Also, the investigators expect that this project will provide evidence to~     consider Xe129 MRI as a diagnostic strategy to assess and monitor therapeutic responses of~     existing and new pharmaceuticals, and thus Xe129 MRI will stimulate development of novel~     therapies for COPD in the future~   "
17648|NCT02826330|"~     Transversal multicentric French study on the microbiota in patients with Crohn's disease and~     their first degree healthy relatives The primary objective is the comparison of microbiota~     between patients with CD, healthy controls non genetically linked and first degree healthy~     relatives of patients with CD.~   "
17649|NCT02826317|"~     Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after~     surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion~     of CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as~     nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are~     the risks of pain chronicization and the duration of the severe pain is longer (5,6).~     However, acute neuropathic pain (ANP) can be present in the postoperative setting. However,~     data on the prevalence of ANP immediately after surgery are scarce and no screening tool has~     been validated so far in this setting. Therefore, the first objective of this multicenter~     observational study is to prospectively describe the incidence of APSNP in a large~     population using the DN4 questionnaire. The second objective of our study is to confirm the~     hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large~     population. It is hypothesized that the systematic use of the DN4 questionnaire in~     postoperative could help detect patients at risk of CPSNP.~   "
17650|NCT02826304|"~     The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal~     hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and~     Postoperative outcomes~   "
17651|NCT02826291|"~     The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with~     histological ultrastaging examination in the sentinel lymph node assessment in patients with~     endometrial cancer.~      The molecular biologic method OSNA is a modern way of metastatic spread detection in~     lymphatic nodes using quantitative reverse transcription polymerase chain reaction.~     Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker~     (detected by OSNA).~      The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could~     help to improve the standards of care in endometrial cancer patients.~   "
17652|NCT02826278|"~     Normal values for female external genitalia size at birth, particularly clitoris and blood~     level of androgens are not well known. This study's aim is to collect normal values in 180~     newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according~     to gestational age and birth weight.~      The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at~     birth, and their evolution until Day 3 of life (if the child is still at the hospital).~      The investigators also want to establish normal values of blood testosterone,~     17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol,~     deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone),~     using samples taken for systematic post natal screening of diseases (only in new born of 35~     or more weeks of birth).~      This is an observational prospective study.~   "
17653|NCT02826265|"~     Current diagnostic tools used in pulmonary disease often do not meet the challenges set by~     the respective pathophysiology. The investigators therefore aimed to evaluate novel or not~     widely used diagnostic approaches for the detection and therapeutic monitoring of patients~     with various pulmonary diseases.~   "
17654|NCT02826252|"~     The aim of this study is to examine inhalation behavior in patients enrolled in the German~     Ventavis patient support program Ventaplus when these patients are switched from Ventavis~     (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.~   "
17655|NCT02826239|"~     The investigators aim to evaluated the effect of postural changes on novel lung function~     parameters derived from multiple-breath-washout.~   "
17656|NCT02826226|"~     The investigators aim to evaluate the effect of bronchodilatator testing on~     multiple-breath-washout derived lung function parameters.~   "
17657|NCT02826213|"~     Comparison of two techniques of renal pre-transplant infusion on the evolution of renal~     function in the recipient: multicentre randomized trial~   "
18332|NCT02817386|"~     The purpose of this study is to investigate the possible relationship of microRNA and~     postoperative delirium.~   "
17658|NCT02826200|"~     The RETORIC study is a prospective cohort study with a primary aim to assess the incidence~     and independent predictors of reduced leaflet motion and valve thrombosis after TAVI~     procedure using multimodality imaging strategy comprising cardiac CT, transesophageal~     echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will~     assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced~     leaflet motion and/or thrombosis when compared with those with normal leaflet function. In~     addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to~     single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.~      The primary outcome of the nested randomized trial will be the presence of reduced leaflet~     motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of~     ischemic changes in brain demonstrated by MRI.~   "
17659|NCT02826187|"~     Total replacement of hip joint is one of the most important medical innovations of the~     twentieth century. More than 100,000 hip replacements are being laid each year in France.~      Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects~     of continuous improvement.~      Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons~     for joint replacement of the defective hip.~      The anchor and friction torque are both essential to the survival of hip implants. Therefore~     acetabular implants without cement with ceramic insert or polyethylene in a metalback or~     full polyethylene coated with titanium grains without metalback are proposed, but they have~     their own complications (Squeaking, fractures, recovery difficulties, difficult radiographic~     analysis, high cost for ceramics, primary stability defects, instability of the instrument~     set, Titanium residues in absence of metalback. An alternative to these implants may be an~     acetabular component without cement with polyethylene insert with an end metalback to~     increase both polyethylene thickness and size of the head in order to expect a low~     complication rate with important longevity for a lower cost.~      This study was conducted to ensure the safety and effectiveness of the acetabular implant~     POLYMAX~   "
17660|NCT02826174|"~     Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for~     more than 100 years. Because conventional PKP is associated with the potential for the~     development of devastating complications such as expulsive suprachoroidal hemorrhage and~     endophthalmitis, we modified the technique to one that is a closed surgery under topical~     anesthesia with the anterior chamber maintained to achieve favorable results. Topical~     anesthesia is an attractive alternative to traditional injection local anesthesia since the~     potentially serious complications associated with retrobulbar and peribulbar anesthesia can~     be avoided. The closed PKP procedure with the stable anterior chamber essentially changes~     the open nature of conventional PKP. The advantages, i.e., decreased surgical risks,~     postoperative complications, and surgical difficulties, make PKP viable in most complicated~     cases.~   "
17661|NCT02826161|"~     This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical~     trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel~     versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung~     cancer who have disease progression following systemic treatment with a platinum-based~     combination regimen in the metastatic setting, who have received treatment with an immune~     checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly~     paclitaxel is an acceptable treatment option.~   "
17662|NCT02826148|"~     The diagnosis of developmental disorders in adults is still difficult. Indeed, in France,~     there is not questionnaires to easily and accurately diagnose this disorder. Several~     diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical~     tool that aims to better identify autism spectrum disorders including mild forms in adult~     people and help to diagnose of high-functioning autism . The objective of this study is to~     perform a complete validation of this scale in the french version.~   "
17663|NCT02826135|"~     The purpose of this study is to evaluate predictability of an abdominal compression-induced~     change of blood pressure for fluid responsiveness in children with single ventricle~     (bidirectional cavopulmonary shunt and Fontan tract).~   "
17664|NCT02826122|"~     The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in~     patients with morbid obesity attending a conservative lifestyle change program, 2)~     investigate effects on cardiac function, cardiorespiratory Fitness, body composition,~     quality of life and cardiovascular risk through the program, 3) investigate feasibility of~     introducing two different activity monitors throughout the program, and 4) comparing~     compliance to activity sensor market leader FitBit Application versus Mio Pai Application~   "
17665|NCT02826109|"~     Periodontal disease is a gum infection caused by plaque on teeth containing both bacteria~     and calculus (hard) deposits. These need to be removed on a regular basis to maintain gum~     health and to prevent teeth weakening. A routine cleaning procedure, scaling/root planing,~     is accompanied with post-operative soft tissue tenderness and teeth sensitivity making oral~     hygiene maintenance difficult during wound healing. The need for novel therapeutic~     approaches, such as cyanoacrylate adhesives, has been identified. It has been hypothesized~     that its application may provide comfort and assist patients with their daily oral self-care~     procedures following teeth cleaning.~   "
17666|NCT02826096|"~     The study is to examine the therapeutic effect of a brief version of biofeedback therapy~     (developed bu the research team) on panic disorder. It is a randomized controlled design.~     The severity of panic symptoms of two groups of panic patients (reveiving biofeedback~     therapy or not) were measured before and after the six week duration. Besides, the severity~     of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.~   "
17667|NCT02826083|"~     Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of~     natural polyphenolic extracts of edible plants) has a significant and favourable effect on~     oxidative stress notably with a decrease in certain markers of oxidative stress and on~     plasma lipid parameters, the investigator proposes to study the effect of 6 months of~     treatment with XXS in a controlled study against placebo in a population of persons~     presenting a lipid profile at the upper limit of normal.~   "
17668|NCT02826070|"~     The purpose of this study is to demonstrate that long-term treatment (up to six years) with~     telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and~     fibrosis/cirrhosis.~   "
18333|NCT02817373|"~     This study is designed to predict implantation of a fresh, high quality embryo in an in~     vitro fertilization (IVF) cycle by using ultrasound based uterine factors.~   "
17669|NCT02826057|"~     This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24~     hours or 48 hours of targeted temperature management.~      The overall aim is to evaluate the importance of plasma complement protein concentrations in~     patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48~     hours of targeted temperature management.~      The specific aim is to evaluate:~        -  the concentration of plasma lectin pathway proteins the first, second and third day~          after cardiac arrest~        -  the relation between concentration of plasma lectin pathway proteins and mortality~        -  if prolonged targeted temperature management influences the concentration of plasma~          lectin pathway proteins~      This study is a sub-study to the trial entitled: Time-differentiated targeted temperature~     management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)~      The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin,~     M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.~   "
17670|NCT02826044|"~     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent~     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose~     study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of~     SP2086 in healthy volunteers.~   "
17671|NCT02826031|"~     This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for~     which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In~     the first 4 weeks (run-in period), the subjects will receive on-demand treatment with~     Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in~     period, the subjects, if their knee pain has not worsened to a level requiring surgical~     treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via~     intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR~     75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR~     75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD）~     may be administered to the subjects of both groups on demand as long as they have a knee~     pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain~     occurs again and requires treatment, oral administration of DICL-SR may be resumed. A~     subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse~     effects.~      A total of 8 visits have been scheduled for this study, including Visit 1/screening period~     (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3),~     Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).~      A total of 300 subjects will participate in this study at 6 to 8 centers in China, and~     patient enrollment is expected to take up to 12 months.~   "
17672|NCT02826018|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV)~     infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with~     HBV.~   "
17673|NCT02826005|"~     Examination the ability to early diagnose HCC by combining three biomarkers technology~     developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and~     the Israeli population.~      This blood test will serve as an additional diagnostic tool tools currently in use~     (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular~     carcinoma.~      Another group that will be examined for all three biomarkers will be patients which already~     diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the~     correlation between the presence of tumor, the number of them and the tumor size and the~     three biomarkers concentration in their blood~   "
17674|NCT02825992|"~     Post Market Clinical Follow-up Study designed to evaluate the incidence of device- and~     procedure-related safety, efficacy, and efficiency (6 and 12 month outcomes) when using the~     AcQMap™ as an imaging and mapping system for ablation of persistent atrial fibrillation~     (AF).~   "
17675|NCT02825979|"~     The EARLY-AF study is centered on an evaluation of the impact of the early invasive~     management of Atrial Fibrillation. The primary goal of the study is to evaluate the clinical~     effectiveness of an early invasive approach. Specifically, the investigators are aiming to~     evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line~     therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms,~     hospitalisations, and health care utilization).~   "
17676|NCT02825966|"~     A prospective, validation study to evaluate the data accuracy of heart sounds recorded by~     the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with~     the heart sounds data recorded by an FDA-cleared device.~   "
17677|NCT02825953|"~     The present study was designed to evaluate, in premature babies with RDS breathing~     spontaneously, the efficacy of combined treatment with nasal continuous positive airway~     pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to~     assess the safety of surfactant nebulization in this clinical situation, and to ﬁnd out~     whether treatment with aerosolized surfactant would reduce the need for mechanical~     ventilation. And other aim suggest that aerosolized dates compared with dates of INSURE~     (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.~   "
17678|NCT02825940|"~     This phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and~     preliminary anti-tumor activity of atezolizumab in Chinese participants with locally~     advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer,~     hepatocellular carcinoma (HCC), and other solid tumor types that are refractory to standard~     therapeutic modalities and for whom no further standard therapy is available or who have~     refused standard therapy.~   "
17679|NCT02825927|"~     The purpose of this study is to determine whether a specific rehabilitation program with~     oral screen used in an elderly population with dysphagia can improve elderly's swallowing~     capacity.~   "
17680|NCT02825914|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has~     proven safe and with no influence on dietary intake. In a pilot study the investigators~     found, that orally administered CGMP seems to have a beneficial effect comparable to that of~     mesalazine in active distal ulcerative colitis.~      The investigators wish to evaluate the effects in a larger group of patients with active~     ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and~     microbiome modulating properties.~   "
17681|NCT02825901|"~     The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on~     cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between~     the supplement and the cardiovascular disease-related gene expression is evaluated. The~     results will be used for the application of functional products for cardiovascular~     protection.~      Ninety subjects (age 30~65) with Prehypertension or Hypertension stage 1 will be included~     and randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects~     will take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2,~     4, 6 and 8. The blood biochemical parameters and gene expression analysis will be examined~     on week 2, 4, 6, 8 and 10 (the follow up).~   "
17682|NCT02825888|"~     Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of~     Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A~     prospective observational cohort study~      Background: Axillary brachial plexus (ABP) block is commonly performed as the primary~     anesthetic technique to provide surgical anesthesia and postoperative analgesia for elbow,~     forearm and hand surgery. Compared to general anesthesia, ABP blocks have been shown to~     result in better pain relief, less nausea and vomiting, shortened length of hospital stay,~     decreased side effects of opioids painkillers and better patient satisfaction. These~     beneficial effects of ABP blocks are particularly useful for patients who are overweight or~     obese as this cohort is at a higher risk of experiencing complications from general~     anesthesia. Traditionally, nerve blocks have been described technically challenging in obese~     patients. This may not be true now with availability of high-resolution ultrasonography~     (US). US imaging also allows doctors the ability to visualize the needle live to allow for~     more accurate needle placement. This allows local anesthetic to be placed more precisely~     resulting in faster onset anesthesia, decreased local anesthetic drug dosages, reduced~     complications and higher success rate. Ultrasound guidance has not been used for performing~     ABP block in previous studies in obese patients.~      Hypothesis: We hypothesize that the block failure rate is no worse in obese compared to~     non-obese patients when US guidance is used to perform ABP blocks.~      Specific Objectives: The primary objective of this study is to evaluate whether obese~     patients receiving US guided ABP block as their primary anesthetic modality have a block~     success rate (defined by a Composite Score ≥ 14 at 30 minutes) worse than their non-obese~     peers. The secondary objective is to evaluate time parameters around ABP performance,~     incidence of complications and patient satisfaction.~      Methods: This study will be conducted as an observational quasi-experimental multicenter~     trial at St. Joseph's Health Care (SJHC), London, ON and the Nova Scotia Health Authority~     (NSHA) Halifax Infirmary (HI) site, Halifax NS. There will be 250 patients taking part in~     this study. One hundred and fifty patients have already completed the study in Ontario. The~     duration of the study at the Halifax Infirmary is 10 months. Healthy patients (aged 18-75~     years) scheduled to undergo elbow/ forearm/ or hand surgery will be invited to volunteer in~     this observational study. A study investigator or resident under direction supervision of a~     study investigator will perform the ABP block. There is NO experimental drug or treatment in~     this study. Patient demographics including age, sex, arm circumference, height, weight and~     Body Mass Index will be recorded. Nerve blocks will be performed in a designated area near~     operating rooms called the block room. US will be used for identification of the nerves~     supplying the arm and an ABP block will be performed with a total volume of 30 mL of 0.5%~     ropivacaine according to a standardized procedure. Measurements of sensory and motor~     blockage will be recorded every 5 minutes for 30 minutes following the ABP block. Block~     success will be measured and is defined as a score of ≥ 14 on the Composite Score (CS)~     within 30 minutes of ABP block completion. According to routine care, all patients will~     receive a phone call from the investigators 24-48 hours after surgery to inquire about~     complications. The study follows non-inferiority design to show that the success rate in the~     obese group is not worse than the non-obese when anesthetized. In non-inferiority trials,~     both intention to treat and per-protocol analysis are recommended; both approaches should~     support non-inferiority The student's t-test (unpaired, two tailed) will be used for~     comparison of the means of continuous, normally distributed data or Mann-Whitney U test as~     appropriate. Categorical data (success rate, complication rate) are to be analyzed using χ2~     test or Fisher's exact test, as appropriate. An interim analysis will not be conducted and~     set at 0.05 for significance and 95% confidence intervals.~      Significance/ Importance: This study would provide anesthesiologists additional information~     to inform their clinical decision-making when dealing with obese patients. To date there are~     no publications or any registered trials exploring the success rates and technical aspects~     of ABP blockade in obese patients using US guidance technology for block performance.~     Therefore, this study is novel and timely for the patient groups.~   "
17683|NCT02825875|"~     In this study we aim to more precisely define the clinical utility of PSMA imaging across a~     range of clinical indications in men with prostate cancer. To accomplish this, we will make~     the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation~     oncologists at Johns Hopkins and survey physicians as to the indication for ordering the~     PET/CT and if a change in management occurred as the result of new information gained from~     the scan. We believe these data will prove critical for planning future studies aimed at~     evaluating the efficacy of this test for improving patient outcomes.~   "
17684|NCT02825862|"~     The investigators aim to experimentally manipulate presence of questions on positive or~     negative affective attitudes to see if including these moderate as intention to become an~     organ donor. The methodology will be replicated across three international sites (RCSI~     Dublin, RCSI Bahrain, RCSI Perdana University).~   "
17685|NCT02825849|"~     Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial~     lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to~     standard therapies, present a significant clinical challenge. The aim of this trial is to~     assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial~     lining thickness in patients with thin lining or Asherman's Syndrome.~   "
17686|NCT02825836|"~     M7583 is an investigational drug that is being evaluated for the treatment of patients with~     B-cell malignancies, which are cancers that form in B cells (cells that are part of the~     immune system). This study has been designed to assess the use of the study drug in patients~     with B-cell lymphomas who have tried and did not respond well (or the B-cell lymphoma came~     back) to at least one but not more than three types of treatment for cancer. This is a Phase~     I/II study, which means that it is looking at several dose levels of an investigational~     medication in terms of its safety and how well it is tolerated in multiple doses. The final~     selected dose will be tested for activity against the tumor in specific populations of~     lymphoma (Mantle cell lymphoma and Diffuse Large B Cell Lymphoma)~   "
17687|NCT02825823|"~     The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and~     can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a~     ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance~     but this has not been adequately studied. The purpose of this study is to determine whether~     supplementing with an acute dose of ketone salts can alter fuel use during exercise and~     improve exercise performance.~   "
17688|NCT02825810|"~     The aim of this study will be to determine the effectiveness of a physical therapy program~     which is based on cervical motor control exercises in long-term breast cancer survivors in~     order to improve their motor control and its possible impact on pain, mood state and quality~     of life.~   "
17689|NCT02825797|"~     This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the~     antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV)~     broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in~     HIV-infected individuals. This study is intended to support the development of the~     combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.~   "
17690|NCT02825784|"~     A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability,~     and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd)~     specially formulated to meet the unique nutritional needs of children from birth to 10 years~     with chronic kidney disease (CKD)~   "
17691|NCT02825771|"~     Suicide is the second leading cause of death for American Indians and Alaska Natives aged~     18-34 years. This study will evaluate Caring Contacts, a low-cost, sustainable intervention~     for suicide prevention that sends caring text messages to people at risk. The investigators~     will implement the intervention at four tribal sites, leveraging community strengths and~     values to address this tragic health disparity in an underserved minority population.~   "
17692|NCT02825758|"~     A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element~     supplement for children aged 11 years and over and adults on a ketogenic or restricted~     therapeutic diet with regard to product tolerance, palatability and compliance.~   "
17693|NCT02825745|"~     In brief, this research is a prospective, feasibility study to evaluate the use of Betashot-~     a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in~     children and adults diagnosed with epilepsy.~      MCT is a type of dietary fat used in the ketogenic diet.~   "
17694|NCT02825732|"~     The investigators will investigate which patients' characteristics are associated with~     caregivers burden and its evolution for outpatients visiting a memory clinic, in particular~     how functional autonomy, behavioral and psychological symptoms as well as patients~     comorbidities can influence caregiver burden.~      The study will be conducted among outpatients with progressive cognitive complaint followed~     in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers~     experience a higher burden due to disease symptoms such as impairment of functional~     autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive~     decline.~   "
17721|NCT02825381|"~     The primary goal of the study is to evaluate the success rate of routine one-stage exchange~     for treatment of chronically infected total hip arthroplasty performed at the investigators~     institution, and to compare it to the current literature reporting success rate of selected~     one-stage exchange procedure or two-stage procedure.~      The secondary goal is to detect the potential prognostic factors and potential selection~     criteria which may influence the success rate. The tested hypothesis is following: the~     success rate of routine one-stage exchange is lower than that of selected one-stage or~     two-stage procedure~   "
17695|NCT02825719|"~     Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to~     menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of~     minimal invasive surgery is limited. There is also increase risk of intraoperative blood~     transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM).~     Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding,~     fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking~     evidence in terms of long term safety and efficacy, especially in Chinese population. The~     aim of the present study is to evaluate the effect and safety on preoperative use of~     Ulipristal on fibroid.~   "
17696|NCT02825706|"~     Although arthropathy is a serious problem in patients with hemophilia due to the associated~     morbidity and incapacity, to the best of the investigators knowledge, no studies have looked~     at the effect of educational physiotherapy for its clinical improvement.~      This contribution presents the results of educational physiotherapy program applied for 15~     weeks with home exercises - in patients with hemophilic arthropathy. After treatment,~     experimental group showed improved a significant reduction of pain, and best quality of life~     al illness behaviour. During treatment no patient showed elbow haemarthrosis, which~     underlines the safety of this physiotherapy program.~   "
17697|NCT02825693|"~     This study aims to examine the health economic impact of adopting femtosecond laser~     technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare~     system, the National Health Service (NHS).~   "
17698|NCT02825680|"~     The overall goal of this project is to test whether the Learn. Engage. Act. Process (LEAP)~     intervention helps teams within the Veterans Health Administration's local MOVE! group~     weight management programs be more in line with guidance. Forty-eight sites will be~     randomized to the LEAP intervention, which is a virtually delivered program that relies on~     the IHI Model of Change, an online learning platform for clinician teams to share ideas and~     progress, an audit and feedback process, and a barrier buster tool. The LEAP intervention~     will be compared to active support that is provided to all VA MOVE! programs by the National~     Center for Health Promotion and Disease Prevention (NCP). The investigators will compare~     whether participation in LEAP results in engaging more Veterans in the MOVE! weight~     management program compared to facilities not participating in LEAP. The investigators will~     also collect information to understand what components of LEAP worked best and how to scale~     up so more teams can participate in LEAP.~   "
17699|NCT02825667|"~     Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial~     therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the~     observed differences on the dependent variables: range of motion, pain and physical~     condition.~      At the same time, the study will determine whether there are adverse effects or bleeding~     complications as a result of applied physiotherapy treatment.~   "
17700|NCT02825654|"~     The purpose of the study is to better understand the health, including lung health, of~     Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi~     Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations.~   "
17701|NCT02825641|"~     The study is intended to compare expectant management and on presentation labor induction in~     women with premature rupture of membranes.~      The means of labor induction and cervical ripening are either oxytocin or dinoprostone.~      Expectant management in this obstetrical state means waiting 24 hours from the onset of~     rupture of membranes and then commencing labor induction with either oxytocin or~     dinoprostone depending on the patient`s obstetrical history and cervical condition.~      The investigators` hypothesis is that active management will lead to a higher rate of~     vaginal deliveries, a shorter interval between the time of rupture of membranes and the time~     of delivery, a lower rate of cesarean sections and a better obstetric result for the mother~     and the fetus/newborn.~   "
17702|NCT02825628|"~     This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre~     study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC)~     and skeletal metastases.~      The primary objective is to evaluate the relative change from baseline in response markers~     related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three~     different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).~   "
17703|NCT02825615|"~     Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and~     conventional method (CM) were compared to find the better technique in general and in~     different hemodynamic subsets of patients.~      Method This is a prospective randomized, single center study of 100 patients. The details of~     the primary cannulation technique, number of attempts, time taken, failure and cross-over~     technique were recorded for three different hemodynamic subsets with Systolic blood pressure~     <80 mm hg, 80-100 mm hg and > 100 mm hg.~   "
17704|NCT02825602|"~     The Vietnam Era Health Retrospective Observational Study (VE-HEROeS) is a national study on~     the health and well-being of Vietnam Veterans, including Blue Water Navy Veterans, as well~     as Veterans who served elsewhere during the Vietnam Era (1961-1975), and similarly aged U.S.~     residents who never served in the military. The investigators will invite approximately~     43,000 Vietnam and Vietnam Era Veterans, and approximately 11,000 members of the general~     U.S. population to participate in VE-HEROeS. These individuals are scientifically selected~     to participate; the study is not able to accept volunteers.~      All participants in VE-HEROeS will be asked to fill out a questionnaire on their military~     service, general health, age-related conditions, health care use, and the health experiences~     of their children and grandchildren. A smaller group will be asked to provide the~     investigators with access to some of their medical records. Topics of special focus for the~     study include cognition, hepatitis C infection, and neurologic conditions.~   "
17722|NCT02825368|"~     The purpose of the study is to compare the immunological response of homeopathic vaccines to~     placebo and to conventional vaccines in healthy young adults.~   "
17723|NCT02825355|"~     This study aims to evaluate the effect of SLN mapping compared to conventional radical PL on~     the incidence and severity of lymphedema in women with early stage cervical and endometrial~     cancer.~   "
17964|NCT02822222|"~     The purpose of this study is to evaluate the safety of RMJH-111b, including how well it is~     tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The~     study will also measure the amount of magnesium in the blood and urine before and after~     RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics).~   "
17705|NCT02825589|"~     Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead~     to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate~     whether more accurate dry weight assessment with BIA in these patients can lead to better~     sleep quality (measured by sleep actigraphy and questionnaires). The investigators will~     enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose~     age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality~     index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of~     consciousness and unstable hemodynamics will be excluded. Then eligible patients will be~     randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The~     investigators will assess participants' dry weight at beginning of study, 3rd month and 6th~     month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep~     questionnaires score, left ventricular mass index by echocardiography, ambulatory blood~     pressure monitoring and blood chemistry results were collected at beginning of study, the~     end of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters~     between the groups. The secondary outcomes are change of sleep questionnaires scores, change~     of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular~     complications between groups.~   "
17706|NCT02825576|"~     The purpose of this study is to determine if the use of sugammadex (compared with~     neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).~   "
17707|NCT02825563|"~     The purpose of this study is to further study the pharmacokinetic characteristics of~     Anlotinib in Advanced Cancer Patients with High Fat Diet.~   "
17708|NCT02825550|"~     The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere~     (T-ACE Beads) interventional therapy for liver cancer~   "
17709|NCT02825537|"~     The main objective of this study is to compare precisely, under standardized test~     conditions, water balance changes in healthy subjects with or without the daytime use of~     compression stocking.~   "
17710|NCT02825524|"~     The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency~     ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia~     or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.~   "
17711|NCT02825511|"~     Assessment of the concordance of the initial clinical and histological diagnosis and to~     explore its prognostic impact in terms of risk of recurrence.~   "
17712|NCT02825498|"~     Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI)~     dependent atrial flutter. We plan to perform a randomized prospective trial comparing the~     efficacy of contact force (CF) guided CTI ablation against catheter ablation with the~     operator blinded to contact force parameters.~   "
17713|NCT02825485|"~     It has previously been found that there is no correlation between degree of hydronephrosis~     and presence of reflux; however this is oftentimes the criteria physicians use to obtain a~     VCUG.~   "
17714|NCT02825472|"~     Rationale: Regular physical activity and aerobic exercise training are related to decreased~     cardiovascular mortality in healthy individuals, as well as in individuals with~     cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available~     on exercise training in adult patients with congenital heart disease.~      Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a~     six-month sports participation program in addition to usual care in symptomatic adult~     patients with congenital heart disease improves exercise capacity and quality of life, and~     lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.~      Study design: International, multi-centre parallel randomized controlled trial.~      Study population: Adult patients with congenital heart disease, who are in New York Heart~     Association (NYHA) class II or III.~      Intervention (if applicable): The intervention group receives a six-month individualized~     exercise training program, the control group receives usual care.~      Main study parameters/endpoints: The primary outcome is the change in peakVO2 between~     patients in the sports participation group, and the control group. Secondary outcome~     measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The~     primary safety outcome is the composite of all hospitalizations, and all deaths during, or~     within three hours after exercise. The secondary safety outcome is the composite of all~     exercise related injuries for which medical attention is sought.~   "
17715|NCT02825459|"~     The purpose of this study is to see whether adults who use e-cigarettes every day experience~     symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.~   "
17716|NCT02825446|"~     Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will~     remove the spasm with macro and microcirculatory blood flow, which increases~     revascularization patency of tibial arteries.~   "
17717|NCT02825433|"~     The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for~     patients receiving procedural sedation during endoscopy procedures in order to observe what~     changes commonly occur.~   "
17718|NCT02825420|"~     Non-interventional, multicenter, prospective, European study to describe the effectiveness~     of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to~     SmPC regardless of previous use of an antiangiogenic drug~   "
17719|NCT02825407|"~     There are few data on elderly people concerning mechanisms involved in the in vivo release~     and perception of aromatic compounds. Any knowledge on this point would be of great interest~     to the scientific community. Concerning the dimensions of sensory perception and in-mouth~     comfort, there is, to our knowledge, no methodology to describe them. These dimensions are~     truly original and innovative, and investigating them will lead to the development of foods~     adapted to elderly populations with chewing and salivation disorders.~      The expected results are:~        -  to obtain two groups of subjects with differences in chewing abilities and saliva~          production~        -  the characterization of flavour release profiles in elderly subjects with regard to~          oral physiology (mastication and salivation) and saliva composition~        -  a sensory profile describing in-mouth comfort when food is eaten~   "
17720|NCT02825394|"~     The investigators study aims to test the correlation between the Cascade Abrazo~     point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of~     apixaban, dabigatran and rivaroxaban, and to determine the diagnostic accuracy of POCT to~     rule out or detect relevant levels of non-vitamin K antagonist oral anticoagulants (NOAC) in~     real-life patients.~   "
17724|NCT02825342|"~     Non cardiac chest pain (NCCP) is defined as recurring, angina-like, retrosternal chest pain~     of non cardiac origin. Annual prevalence of NCCP in the general population of the western~     world ranges from 25-35%. Of those patients presenting to an emergency room with chest pain,~     a cardiac etiology is ultimately found in only 11-39%. Several conditions are associated~     with NCCP, with gastroesophageal reflux disease (GERD) being the most prevalent,~     constituting up to 60% of cases. However, NCCP is considered a disorder of heterogenous~     nature and several other conditions, apart of GERD, such as esophageal dysmotility and~     esophageal hypersensitivity have been implicated.~      Treatment of NCCP remains a real challenge due to the diverse underlying mechanisms~     responsible for patients' symptoms. Given the fact that GERD is by far the most common~     etiology, proton pump inhibitor (PPI) therapy has been tried extensively; however, after 6~     weeks of treatment complete resolution of symptoms occurs in only 30% of patients, the~     optimal duration of PPI administration is not known, while the best maintenance dose has~     never been determined. Although the administration of selective serotonin reuptake~     inhibitors (SSRIs) could theoretically benefit those patients with esophageal~     hypersensitivity, the trials that have been published so far have included small number of~     patients and reported conflicting results, while the co-administration of PPIs with SSRIs~     has not been evaluated so far. Furthermore, data on treatment of patients with functional~     chest pain are lacking.~   "
17725|NCT02825329|"~     Open-label, non-controlled study of standard care plus the TORAYMYXIN PMX-20R (PMX~     cartridge) in subjects who have endotoxemia and septic shock. This is a continued access~     study subsequent to the EUPHRATES clinical trial NCT01046669.~   "
17726|NCT02825316|"~     This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on~     therapy for induction of remission in adult patients with active Crohn's disease and to~     evaluate its effects on clinical, inflammatory and microbial parameters.~   "
17727|NCT02825303|"~     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases,~     diabetes, several types of cancer and all-cause mortality. In combination with static and~     awkward postures, the prevalence of musculoskeletal diseases can increase further. Although~     the implementation of sit-to-stand or active workstations can help to reduce sitting time,~     improve physical activity at work and promote health benefits, it might also lead to changes~     in cognitive functions such as productivity The purpose of this study is to evaluate the~     mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as~     physiological and cognitive parameters for healthy people of working age in comparison to~     their traditional workplace.~   "
17728|NCT02825290|"~     This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with~     modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of~     ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone~     only in ovulating women.~   "
17729|NCT02825277|"~     Introduction~      Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy~     complications related to chronic utero-placental hypoperfusion. Three-dimensional power~     Doppler (3DPD) angiography has been used for the evaluation of utero-placental~     vascularisation and three vascular indices have been calculated: the vascularisation index~     (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints~     hinder the clinical use of 3DPD as physical characteristics and machine settings may affect~     3DPD indices, and so its clinical significance is not yet clear.~      Objectives~      The primary objective is to better understand the clinical significance of 3DPD indices by~     evaluating the relationship between these indices and placental morphometry. Secondary~     objectives are (i) to determine the impact of machine settings and physical characteristics~     on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation~     patterns.~      Methods and analysis~      This is a prospective controlled study. We expect to include 112 women: 84 with normal~     pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for~     PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent~     caesarean section, utero-placental 3DPD images with five different machine settings will be~     acquired. Placentas will be collected and examined after surgery and stereological indices~     (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and~     VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler~     and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between~     3DPD indices and morphological indices will be assessed by Bland and Altman plots. The~     impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated~     with a multivariate linear regression model.~   "
17730|NCT02825264|"~     STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting~     anti-fibrotic properties. Release of this CE Marked implant has been limited to leading~     Glaucoma Centers in Europe. Therefore this Clinical Experience Program is being initiated to~     expand the surgical and clinical practice knowledge about the use of STARflo for reducing~     intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world~     population of patient.~      This program is designed to be an international multicenter observational study Patient data~     may be collected retrospectively and/or prospectively for up to 5 years after surgery.~      The aim of this program is to document the patient's benefit following implantation of the~     STARflo implant in a real-word patient population, to learn about surgical practices and to~     collect data to support future cost-effectiveness analysis~   "
17731|NCT02825251|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of~     Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.~   "
17732|NCT02825238|"~     The purpose of this research is to develop and test the feasibility of an exercise~     intervention for persons with painful knee osteoarthritis involving the patella (kneecap).~     Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week~     supervised exercise program that targets strengthening the hip and trunk core muscles.~     Painfree control participants will attend one session to gather biomechanical, strength, and~     function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility~     outcomes include adherence to the treatment program, recruitment, and retention. It is~     hypothesized that PFOA group participants will change score on a knee pain and function~     questionnaire by the minimum clinically important difference score for positive improvement~     at the end of the 6-week intervention program.~   "
17733|NCT02825225|"~     The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy.~     The secondary objective is to evaluate pain perception using a validated scale to compare~     the analgesia provided by the two different local anesthesia schemes. Data will be~     prospectively collected from patients who will undergo prostate biopsy in a single high~     volume urology center. The patients will be randomized to two different biopsy samplings and~     two local anesthesia schemes.~   "
18355|NCT02817087|"~     Transcranial magnetic stimulation for post-stroke upper-body motor deficits.~   "
17735|NCT02825199|"~     Objective: Assess the effect of caffeine in the following vestibular function tests:~     Cervical Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and~     Caloric Test.~      Methods: Randomized, prospective triple-blind, placebo controlled clinical trial. All~     participants underwent otoscopy, tympanometry, responded to the Profile of Mood State~     (POMS), submitted to the cVEMP, oVEMP and caloric tests. After that they received placebo or~     caffeine capsule (300mg) and repeated the procedures 45 minutes after.~   "
17736|NCT02825186|"~     The purpose of this study is to compare the efficacy and side effects of topical Loteprendol~     etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.~   "
17737|NCT02825173|"~     The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for~     the reinforcement and protection of gastrointestinal anastomosis.~   "
17738|NCT02825160|"~     This study is collecting post-marketing information on the safety and effectiveness of~     Ventavis under the routine clinical practice for patients with PAH~   "
17739|NCT02825147|"~     Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in~     Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients.~     Asparaginase-based treatment has been demonstrated as promising response rate and survival~     superiority. Stage-specified regimen may bring out exciting efficacy with good safety.~   "
17740|NCT02825134|"~     A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic~     valve replacement in patients 75 years of age or younger suffering from severe aortic valve~     stenosis.~      Study hypothesis: The clinical outcome (composite endpoint of all-cause mortality, MI and~     stroke) obtained within 1 year after TAVR is non-inferior to SAVR.~   "
17741|NCT02825121|"~     Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis~     by stimulation of the ulnar nerve at the wrist.~      However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort,~     arterial catheterization), it is impossible to access the patient's wrists, delaying~     monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient~     extubation , leading in some cases to single injections lack of control of the reversal of~     the patient.~      To overcome these technical difficulties, a group nerve / muscle looks interesting and often~     easily accessible to the anesthesiologist.~      The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis~     brevis muscle and allows quick access to monitoring the reversal before the end of the~     intervention.~      The primary outcome was to compare the speed of recovery from neuromuscular block flexor~     hallux versus that of the adductor pollicis.~      The secondary objective was to compare the speed of installation of deep neuromuscular block~     flexor hallucis versus that of the adductor pollicis.~      This is a prospective, exploratory, uncontrolled, single-center for routine care.~      Are included all aged patients over 18 years, ASA I or II, without guardianship, having no~     known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach,~     predictable difficult intubation .~   "
17742|NCT02825108|"~     The present study is designed as a pilot study with 50 patients in each group. Data~     collection form will be filled by the researcher who does not know the type of intervention~     in each group~   "
17743|NCT02825095|"~     Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in~     treatment of patients with malignant pleural effusion~   "
17744|NCT02825082|"~     EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS~     AFFECTING MORBIDITY AND MORTALITY~   "
17745|NCT02825069|"~     This general population based, randomized controled trial aims at answering two major~     hypotheses: First, systematic early introduction of solid foods decreases the incidence of~     food allergy and dietary restrictions by the age of one year. Second, stimulation with the~     symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe~     allergic symptoms.~   "
17746|NCT02825056|"~     There is paucity of literature on the effects of intrathecal morphine on the postoperative~     hemodynamics in the cardiac-surgical patients.We planned this study to compare the~     post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two~     study groups) and outcome of combined general anesthesia + high spinal block, with or~     without intrathecal morphine in patients undergoing cardiac-surgical procedures in our set~     up.~   "
17747|NCT02825043|"~     The primary objective of this study is to look for a correlation between the use of HFNC in~     the outpatient setting in patients with previous COPD exacerbation and the change in their~     BCSS score. The hypothesis is that home use of HFNC will lead to a reduction in BCSS score~     by 1.3.~   "
17748|NCT02825030|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17749|NCT02825017|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17750|NCT02825004|"~     The purpose of this study is to prevent burnout and offer the hospital staff a space for~     processing the emotional experiences.~   "
17751|NCT02824991|"~     Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with~     the purpose of obtaining local twitch responses (LTRs), which are highly effective in~     releasing MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR~     intensities required for optimal clinical results are poorly understood, especially in~     relation to range of motion after intervention. Therefore, evaluating the intensity of LTRs~     is relevant for implementing DN in different clinical settings, such as in patients with~     muscular or neurological dysfunctions. One way to assess muscle contractions and LTRs is~     through ultrasound video analysis.~      The aim of this report was to evaluate the reliability of semi-automatic LTR intensities~     tracking during dry needling by assessing ultrasound signals with an image processing~     method, in addition to evaluating the relationship between LTR intensities and muscle~     elasticity.~      Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary~     outcome measure was the LTR intensities determined by percentage change of muscle thickness.~     The secondary outcome measures were the muscle elasticity of medial gastrocnemius and~     hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs,~     detected by a physical therapist and ultrasound assessment, were induced by inserting a~     filament needle into muscle latent trigger points in medial gastrocnemius. The intensities~     of LTRs were measured by assessing ultrasound images using an optical flow method and~     through comparisons with manual detection.~   "
17752|NCT02824978|"~     to evalute if therapeutic alliance is related to adherence in JIA~   "
17753|NCT02824965|"~     This will be a Phase Ib open-label trial of CAVATAK™ (CVA21) in combination with~     Pembrolizumab for the treatment of patients with advanced NSCLC. The dose of Pembrolizumab~     will be fixed at 200mg. Three cohorts (dose levels) of intravenously-delivered CVA21 will be~     explored, using a standard 3+3 patient dose escalation design. The starting dose of CVA21~     will be one log below the 1 x 10^9 TCID50 dose found to be safe when CVA21 was given alone~     in an ongoing Phase I study (NCT02043665).~   "
17754|NCT02824952|"~     Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be~     done by PET-CT scan after 6 weeks.~      In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding~     patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of~     response assessment at each time-point).~   "
17755|NCT02824939|"~     This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block~     with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of~     performance and safety when administered postoperatively in patients who undergo~     laparoscopic nephrectomy.~      To fulfill this purpose, three groups of patients each with 32 patients, will be formed.~     Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group~     will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after~     completion of surgery. The third (Control group) will not receive any blocks. After shifting~     patients to recovery all three groups will be put into intravenous patient controlled~     analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine~     consumption over the first postoperative 24 hours, ease of performance of individual blocks~     and associated adverse events, adverse events associated with opioid use, patient recovery~     and satisfaction will be noted.~   "
17756|NCT02824926|"~     This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate~     efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active~     control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises~     enrollment, treatment and follow-up visits. Treatment period is 14 days.~   "
17757|NCT02824913|"~     The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive~     techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the~     administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry~     eye disease.~   "
17758|NCT02824900|"~     The purpose of this study is to investigate the effects of vibration stimuli to contra~     lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke~     patients.~   "
17759|NCT02824887|"~     Compare the curative effects of electroacupuncture deep needling difference in efficacy of~     the conservative treatment for lumbar five point therapy and routine western medicine, to~     explore the efficacy and superiority, open a new way for the treatment of lumbar disc~     herniation.Through a comparative analysis of the data on the efficacy of different TCM~     Syndrome Types in the subgroup of patients with, to explore the effect of Electroacupuncture~     of deep needling and five lumbar acupoint therapy is most suitable for the TCM syndrome~     type.Through follow-up, patients in the two groups moment condition and the survival of the~     state was evaluated, explore the effect of electroacupuncture deep needling the long-term~     effects of five lumbar acupoint therapy for treatment of lumbar disc herniation and factors~     that may influence the recurrence of symptoms.~   "
17760|NCT02824874|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     lobeglitazone and sitagliptin in healthy male volunteers.~   "
17761|NCT02824861|"~     This study evaluates a technology based intervention (physical activity tracker, text~     messages, health coach, global positioning system enabled location based feedback on~     physical activity) to support physical activity in cancer survivors after completing~     oncology rehabilitation. In Phase 1 all participants received the full intervention. In~     phase II participants are randomly assigned to receive the full intervention or a fitbit~     only.~   "
17762|NCT02824848|"~     Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes~     the infant to tilt the head to one side and turn it to the other side. Infants with CMT also~     show unequal use of both sides of the body for movement and play. In this randomized~     clinical trial, researchers will compare two physical therapy (PT) treatment methods,~     passive stretching and Perception-Action (P-A) Approach, in their effects on head position~     and use of both sides of the body in infants with CMT. Behavior demonstrated during PT~     sessions by infants in the two groups will be also compared. Thirty-six infants with CMT~     will be randomly assigned to a passive stretching group or a P-A Approach group. The infants~     in both groups will attend 5 weekly PT sessions, including the initial evaluation, 3~     subsequent weekly sessions, and a re-evaluation session. At visits 1 and 5, each infant's~     habitual head position, the ability to turn the head to both sides, muscle strength on both~     sides of the neck, motor development, and use of both sides of the body for movement and~     play will be assessed. Each infant's behavior exhibited during therapy will be assessed at~     visits 2-4. Results obtained from the two groups will be compared.~      It is hypothesized that:~        1. There will be significant gains achieved by both intervention groups between the~          initial and final assessments on the following outcome measures:~             1. Still photography~             2. Arthrodial goniometry used to assess active head rotation to both sides~             3. The Muscle Function Scale (MFS) used to assess neck muscle strength~             4. The Alberta Infant Motor Scale (AIMS) used to assess motor development~        2. There will be no significant difference between the groups on the above listed measures~          after the intervention is completed.~        3. The P-A Approach group will achieve greater gains than the passive stretching group~          between the initial and final assessments on the Functional Symmetry Observation Scale~          (FSOS) used to assess the use of both sides of the body for movement and play~        4. The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than~          the passive stretching group assigned based on participants' behavior demonstrated~          during PT intervention sessions~   "
17763|NCT02824835|"~     The purpose of this study is to determine the effects of the plant hormones strigolactones,~     on cell cultures of colonic polyps and colorectal cancer.~   "
17764|NCT02824822|"~     Epilepsy is a common condition which affects over 3 million people in the US. Patients with~     uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which~     is greatest in those under 40 years of age. The exact mechanisms and causes are not~     understood but can be due to underlying conditions which affect the heart and brain, which~     may lead to dangerous heart rhythms and death. Some of these conditions which affect heart~     and brain have an identifiable genetic cause. This study aims to identify known genetic~     causes of heart rhythm and sudden death related disorders in patients with epilepsy.~   "
17765|NCT02824809|"~     The Aims of the study are estimate the association between the severity of COPD and free~     testosterone level and the prevalence of hypogonadism in adult men with stable COPD~   "
17766|NCT02824796|"~     The purpose of this study is to determine whether a new parent training protocol for~     children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of~     the art Parent Training protocol (PBT) by increasing the long term effectiveness of the~     treatment, reducing the dropout rate and reducing the comorbidities.~   "
17768|NCT02824770|"~     Endogenous melatonin is produced by the pineal gland at night under normal conditions and~     regulates the sleep-wake cycle. Artificial light administered at night suppresses melatonin~     production and sleep disturbances are accompanied by abnormal melatonin secretion such as~     phase delay. Therefore, dramatic disturbances of endogenous rhythms in intensive care unit~     patients have remarkable effects on melatonin production. In addition to its physiological~     roles in regulating sleep patterns, melatonin has been demonstrated to provide~     antiinflammatory effects in experimental models. Although some previous studies have~     investigated the circadian pattern of melatonin in intensive care unit patients, the~     investigators think that the present study is the first one that will assess the effects of~     controlling noise and light on melatonin and inflammatory response after major abdominal~     surgery.~   "
17769|NCT02824757|"~     This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in~     patients with interstitial lung disease. Patients with interstitial lung disease who is on~     the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose~     monitoring (CGM). The data attained from the CGM are used to define the glycemic~     characteristics in patients using glucocorticoids and the difference of glucose features due~     to different doses.~   "
17770|NCT02824744|"~     The purpose of the study is to evaluate prospectively the clinical benefits of 2 different~     flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial~     management of bronchiolitis in infants.~      Design: Prospective, controlled, randomized, multi-center.~      Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory~     distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will~     be randomized in two groups:HFNC 2l/min/kg or HFNC 3l/min/kg during 24 hours.~      Conditions of measurements:~      Primary endpoint: Proportion of failure in both arms during the first 24 hours.~      Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point)~     or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above~     4) or apnea.~      Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN~     score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%,~     transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2~      Statistic: Intention to treat Analysis.~      Expected number of patients: 135 per arm: 270 children.~   "
17771|NCT02824731|"~     This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with~     different radiation modalities - protons or photons. Patients with different kinds of brain~     tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is~     that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after~     proton compared to photon treatment.~   "
17772|NCT02824718|"~     Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce~     sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic~     activity. The most common cause of hypoparathyroidism is damage to or removal of the~     parathyroid glands due to neck surgery for another condition. Hypoparathyroidism can also be~     caused by an autoimmune process. In rare cases, hypoparathyroidism may occur as a genetic~     disorder inherited as an autosomal recessive, autosomal dominant or X-linked recessive~     trait. The autosomal dominant hypocalcemia (ADH) is mainly caused by heterozygous activating~     mutations in the CASR gene encoding CaSR). ADH differs from other cause of~     hypoparathyroidism by the increased risk to develop hypercalciuria and nephrolithiasis. The~     purpose of the study is to compare two therapeutic approaches in ADH in order to limit the~     risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia:~     rhPTH(1-34) vs association of active vitamin D and hydrochlorothiazide.~   "
17773|NCT02824705|"~     Study investigators will develop a biomarker-based EN decision rule for post-operative~     infants with CHD. Investigators lack objective data to inform decisions regarding provision~     of EN, an area where subjective decision-making is currently the rule. Lack of standardized~     practices for post-operative feeding lead to EN practice variation, which may harm these~     infants with regard to septic morbidity and long-term neurocognitive outcomes. Study~     investigators will address gaps in knowledge regarding the emerging role of the~     gastrointestinal tract as a modulator of SIRS, sepsis, and organ dysfunction after CPB~     during childhood. Finally, this proposal will inform the design of future studies to provide~     individualized, safe EN support, targeted to intestinal EBF. This proposal presents several~     innovations. First, the investigators will explore the gastrointestinal tract as a way to~     improve post-operative outcomes after surgical repair of CHD in infants. Second, the~     investigators will develop a feeding intolerance scale for use in future studies of EN~     titration in infants with CHD. Third, this proposal prospectively evaluates biomarkers of~     intestinal EBF in infants with CHD, a major advance in biomarker development in this field.~   "
17774|NCT02824692|"~     The purpose of this study is to determine whether a focused ultrasound examination for the~     heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant~     clinical findings in elderly patients before emergent surgery.~   "
17775|NCT02824679|"~     A case control study conducted on 120 women coming to Cairo University Maternity Hospital~     .Patients who meet the inclusion criteria were asked to participate in the study and a~     verbal consent was obtained from each patient. Patients will be divided into three equal~     groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be~     injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be~     monitored in bed. Vaginal examination will be conducted every two hours. The duration of the~     first stage was calculated from the time of cervical dilatation of three to four centimeters~     in active labour until a fully dilated cervix will be observed~   "
17776|NCT02824666|"~     This study involves evaluating the occupancy of ATI-9242 at steady state at three different~     dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts~     of subjects.~   "
17777|NCT02824653|"~     Graft versus host disease is a serious and often life-threatening complication in allogeneic~     haematopoietic stem cell transplantation. Although corticosteroids are the first-choice of~     treatment in these patients, but about 30-50% patients do not respond to it and develop~     steroid-refractory GVHD. Mesenchymal stem cells (MSC) have emerged as a promising treatment~     option in these patients. This phase-I/II clinical trial aims at establishing the safety and~     clinical efficacy of allogenic ex-vivo cultured MSCs to treat steroid-refractory GVHD in a~     Pakistani HSCT cohort.~   "
17778|NCT02824640|"~     People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other~     groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have~     been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are~     expensive, so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to~     prescribe DAAs because they are concerned that PWID won't take their medication or that~     these patients might become reinfected.~      Several good models for treating PWID exist. One of them is to provide directly observed~     treatment (DOT). Another model provides treatment to PWID with the support of patient~     navigators (PN), public health workers who offer support and education to patients. Though~     both the DOT and PN models have been successful, we still don't know which model works best.~      In this study, the investigators will study both DOT and PN models for treating HCV in PWID.~     The investigators' goal is to find out which model produces the best results and is~     preferred by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight~     sites around the country. Patients will be randomized into either the PN or the DOT groups.~     Patients who end up in the PN group will get a biweekly blister pack of medication to take~     home. Their PN will provide education and support. The investigators will find out whether~     patients adhered to medication using an electronic adherence monitoring system. Patients who~     are randomly assigned to the DOT group will take their medication in front of a staff~     member.~   "
17779|NCT02824627|"~     Irritability and emotional dysregulation are recognized as serious aspects of~     psychopathology seen in in pediatric psychiatric patients. While various behavioral as well~     as psychopharmacological interventions have shown some efficacy in improving irritability~     and emotional dysregulation, there are no data determining the neurobiological mechanism of~     effect at the neural level. Previous studies have demonstrated that heightened amygdala~     response to negative emotional stimuli is closely related to irritability and emotional~     dysregulation in children and adolescents. Also, there are studies showing administration of~     oxytocin can decrease the heightened amygdala response to negative emotional stimuli across~     various psychiatric diagnoses. This study is a double-blind randomized trial of oxytocin for~     irritability and emotional dysregulation in the pediatric population. Neuroimaging~     modalities of fMRI and MEG are employed to probe the neuro-circuitry changes occurring as a~     result of the oxytocin intervention, specifically including heightened amygdala response to~     negative emotional stimuli and dysfunctional fronto-amygdala connectivity. The investigators~     will also investigate the genetic sequence of the oxytocin receptor in the study~     participants and its relationship with symptom profile and neural activity changes. Children~     and adolescents (age 10-18) with a diagnosis of disruptive mood and/or behavior disorders~     (including Attention Deficit/Hyperactivity Disorder [ADHD], Oppositional Defiant Disorder~     [ODD], Conduct Disorder [CD], and Disruptive Mood Dysregulation Disorder [DMDD]), and~     clinically significant levels of irritability and emotional dysregulation as measured by the~     Affective Reactivity Index Scale (score>/= 4).~      2 weeks randomized, double-blind treatment with intranasal oxytocin (24 IU daily, or 12 IU~     daily if the weight is < 40kg) with assessment of diagnosis, symptom profiles (the Affective~     Reactivity Index [ARI], Inventory of Callous-Unemotional Trait [ICU], Behavior Assessment~     System for Children, second version [BASC-2], and Clinical Global Impression [CGI]) and pre-~     and post-oxytocin treatment neuroimaging (fMRI and MEG). The genetic sample will be obtained~     via buccal mucosa sampling.~      Participants may receive outpatient clinically indicated follow-up care in the UNMC~     department of psychiatry or other local community agency as appropriate.~   "
17780|NCT02824614|"~     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes~     in the food industry and are also recommended to diabetic patients. Both substances are~     already in use in the food industry and are freely available. Since the 1970s, beneficial~     effects on oral health could be demonstrated as oral bacteria were influenced positively.~     Animal studies showed an increase in gut Clostridium perfringens after xylitol intake;~     certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on~     the human gut microbiota are lacking so far. In this trial, investigators aim to examine~     whether gut microbiota and glucose tolerance can be influenced by polyol intake in a~     non-diabetic but obese cohort.~   "
17781|NCT02824601|"~     This randomized clinical trial evaluated the effectiveness of supplemental photodynamic~     therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected~     root canals after one-visit and two-visit treatments.Twenty-four primarily infected root~     canals with apical periodontitis were selected and randomly divided into one-visit (n=12)~     and two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using~     the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17%~     Ethylenediamine tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL)~     was applied to root canals for 60 seconds and submitted to laser with a potency of 60~     milliwatts (mW) and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit~     treatment and after 14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL)~     in the two-visit treatment. Samples were collected before and after root canal procedures.~     Endotoxins were quantified by chromogenic limulus amebocyte lysate assay. Culture techniques~     were used to determine bacterial colony-forming unit counts.~   "
17782|NCT02824588|"~     The goal of this project is to investigate and improve executive control function in two~     distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized~     that there is a significant difference in the executive control function of patients with~     neuropathic pain and FM pain. It is also hypothesized that all participants with poor~     executive control functioning will report significant improvements in pain intensity,~     functioning and cognitive complaints following cognitive training. The study tests and~     influence the working memory concepts of inhibition, updating and flexibility through an~     experimental, cross-over treatment design.~      To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80~     with FM) from the Departments of pain management and research at St Olav's University~     Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine~     whether or not executive control, processing speed and memory function differs in two~     distinct populations of pain patients. Moreover, whether impairments are amended by~     computerized training.~   "
17783|NCT02824575|"~     The purpose of this study is to determine the safety and tolerability of rebastinib when~     combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced~     breast cancer.~   "
17784|NCT02824562|"~     Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine~     has described chronic pain as a complex chronic disease and a national public health~     crisis. The unique neurobiological basis and psychosocial context of chronic pain in~     HIV-infected patients underscores the importance of developing and testing a behavioral~     intervention specifically tailored to this population. This study will pilot test a~     newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.~   "
17785|NCT02824549|"~     The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system~     in children will be evaluated by questionnaires, pictures of the insertion site and~     comparison of the glucose results with capillary blood glucose determinations.~   "
17786|NCT02824536|"~     This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly~     neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074,~     when given in combination, in human immunodeficiency virus (HIV)-uninfected individuals.~     This study is intended to support the development of the combination of 3BNC117 and 10-1074~     mAbs for use as prophylaxis against HIV infection in healthy HIV-uninfected individuals at~     risk for HIV infection.~   "
17787|NCT02824523|"~     The purpose of this research study is to learn new information about the underlying cause of~     aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy.~     AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to~     aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on~     individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for~     clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and~     subsequent treatment with daily high-dose oral aspirin is standard of care for patients with~     AERD who do not respond adequately to steroids and have recurrent nasal polyposis or~     symptomatic asthma. This study will involve four visits to Brigham and Women's Hospital and~     will align closely with the standard of care for the treatment of AERD.~   "
17788|NCT02824510|"~     The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG~     evolution without insulin dose modification in patients with T1D under continuous~     subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare~     differences between these 2 groups; 2) to evaluate the impact of insulin dose modification~     (bolus, basal, reduction or increase, based on SG evolution profile obtained after first~     exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen,~     and compare differences between these 2 groups.~   "
17789|NCT02824497|"~     Respiratory distress is one of the first hospital grounds during the neonatal period. The~     clinical presentation and severity vary by gestational age and cause. She reports to various~     etiological factors as maternal, neonatal or sometimes entangled. The symptomatic management~     has benefited from organizational progress (perinatal care) and techniques, including~     antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so~     that the use of intubation is less frequent. The short-term evolution of patients with early~     respiratory distress is based on gestational age, cause and initial management.~   "
17790|NCT02824484|"~     This study aims to investigate the efficacy of Guided Written Disclosure Protocol (GWDP) in~     promoting post-traumatic growth through a process of meaning reconstruction in cancer~     patients at the end of chemotherapy. Also, the intervention (GWDP) intends to reduce~     distress symptoms (i.e. intrusive thoughts, avoidance, depression and anxiety).~   "
17791|NCT02824471|"~     'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated~     heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a~     consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red~     cell membrane properties, shape, and density, and subsequent critical changes in~     inflammatory cell and endothelial cell function. Our goal is to understand the impact of CMA~     abnormalities in SCD, by interrogating a number of recognized interactions in a range of~     clinical phenotypes.~      To date, correlative studies in SCD, by us and others, have range between clinical reports,~     based on tests, interventions, and chart review of individuals or groups of individuals and,~     at the other extreme, identification of functional gene polymorphisms based on population~     studies. The investigators wish to augment these studies through a systematic examination of~     cellular membrane properties and activation status. Of hematologic disorders, SCD may be~     unusually susceptible to such an examination.~   "
17792|NCT02824458|"~     The main purpose of this study is to evaluate the safety and efficacy of Apatinib in~     combination with Gefitinib as compared to placebo in combination with Gefitinib in~     participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an~     activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and~     tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion~     (Part A) before proceeding to the second portion of this study (Part B).~   "
17793|NCT02824445|"~     After 13 years of war, PTSD has become pervasive in service members. Traditionally it is~     evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing~     therapy, prolonged exposure therapy and medication management with limited success.~     Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving~     individual cognitive function in the past decades, both in healthy population and in~     patients with depression. TMS has been approved by the FDA in treatment of major depressive~     disorder and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of~     individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to~     treat veterans with war-related PTSD, a syndrome that includes depressive and anxious~     symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better~     than the current FDA approved methods for treating PTSD.~   "
17794|NCT02824432|"~     The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085)~     on vascular endothelial function when administered for 8 weeks, as measured by FMD, in~     patients with hyperlipidemia.~   "
17795|NCT02824419|"~     The goal of the current study is to evaluate the potential of the selected PET tracers to~     detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the~     detection of certain inflammatory processes or malignant tumors, and their targets present~     similarities with molecular mechanisms of sarcoidosis.~   "
17796|NCT02824406|"~     The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR)~     measurements in adult patients with Sickle Cell Disease (SCD).~      The primary objective is to assess whether there is a correlation between CVR and silent~     cerebral infarcts (SCIs).~   "
17797|NCT02824393|"~     The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal~     Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.~   "
17798|NCT02824380|"~     An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/~     Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.~   "
18002|NCT02821715|"~     This Phase 2 study is a 3-site, double-blind, randomised, placebo-controlled, 3-way~     cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug~     THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).~   "
17799|NCT02824367|"~     Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer~     of depression and / or anxiety. Also, clinicians reported that they exhibit specific~     personality traits (e.g., rigidity and perfectionism).~      To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's~     disease showing promising results. Recently, perfectionism has received particular attention~     because of it association with many emotional disorders. Thus, some psychometric tools have~     been developed in order to evaluate different aspects of perfectionism. Yet, none of them~     has been used in people with Parkinson's disease.~      The objective of this study is to investigate whether there is a direct link between~     Parkinson's disease and perfectionism by using psychometric tools from the CBT literature.~     Identifying such link would allow to justify the use of CBT in people with Parkinson's~     disease with the goal in mind to improve their care and quality of life.~   "
17800|NCT02824354|"~     Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of~     alcohol consumption. It appears to be significantly more effective in the group of heavy~     drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is~     greater than 120 g/day.~      No data are available concerning nalmefene in alcohol-dependent patients with alcoholic~     cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy~     drinking in patients with alcoholic cirrhosis, with potential improvement of liver function.~     No comparator is available for nalmefene, as all other molecules require abstinence prior to~     starting treatment.~   "
17801|NCT02824341|"~     Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder~     (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic~     system and brainstem.~      Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic~     drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic~     pathways which belong to the so-called reward system.~      A strong link was found between these two disorders and therefore the investigators believe~     that RBD is associated with impaired reward system.~      The main objective of this study is to evaluate differences in brain activation between PD~     patients with and without RBD.~      The investigators hypothesize that PD patients with RBD have a more severe dysfunction of~     the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without~     RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic~     treatment.~   "
17802|NCT02824328|"~     The investigators propose to collect biologic samples (i.e. tumor tissue, ascites, and/or~     blood), from patients undergoing standard of care therapy for a gynecologic malignancy. To~     detect changes in the immune response following chemotherapy, collection of biologic samples~     will occur at baseline and at the time of surgery following chemotherapy.~   "
17803|NCT02824315|"~     The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of~     simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS~     022227), when these drugs are co-administered in healthy Japanese participants.~   "
17804|NCT02824302|"~     Labor pain is complex to understand and challenging to define because of the interaction of~     multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result~     in harmful physiological and psychological consequences for both mother and baby. It is~     therefore important to understand the prelabor factors that may affect the labour pain to~     facilitate the intrapartum pain management. The goal of this prospective observational study~     is to verify if expectations regarding pain experience translate to actual pain outcomes for~     women who are undergoing induction of labor.~   "
17805|NCT02824289|"~     A sample of local government organizations are recruited to a group-randomized~     pretest-posttest controlled trial evaluating the effect of a campaign to promote workplace~     policy and education on sun protection for outdoor workers. Primary outcome is adoption of~     formal policies and secondary outcomes are implementation of policy and sun protection~     practices by outdoor workers.~   "
17806|NCT02824276|"~     Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of~     disability and reduced quality of life. The prescription of opioids for chronic low back~     pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the~     CDC in their recent Guideline (released in March 2016): Opioids are commonly prescribed for~     pain. An estimated 20% of patients presenting to physician offices with noncancer pain~     symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid~     prescription. Interestingly, patients scoring very high on measures of psychological~     distress tend to be systematically excluded from RCTs, even though this subgroup of patients~     is highly prevalent within the chronic pain population.~      This study will provide key information on individual differences in the outcomes of opioid~     treatment, and its findings should facilitate more effective tailoring of analgesic regimens~     to individual patient characteristic.~   "
17807|NCT02824263|"~     Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown~     mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid~     metabolism during sleep, which over time could lead to diabetes and cardiovascular disease.~     This study examines metabolic changes during sleep in patients with obstructive sleep apnea.~     Patients accustomed to CPAP therapy are enrolled to undergo sleep studies, either on CPAP~     therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are~     obtained so that metabolic function can be compared between sleep apnea and CPAP nights.~   "
17808|NCT02824250|"~     The primary aim of this study is to conduct a randomized controlled feasibility trial of~     MBSR for patients with moderate-to- severe migraine headache.~   "
17815|NCT02824159|"~     Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic~     Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and~     Mantle cell lymphoma (MCL) for idelalisib.~      Clinical trials for ibrutinib and idelalisib were performed with a small number of patients~     (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of~     these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this~     study is to determine the association between clinically significant side effects occurrence~     during the first year of treatment and plasma mean concentration of the steady state of~     ibrutinib or idelalisib at 1 month.~   "
18003|NCT02821702|"~     This study is the first to investigate the fertility outcome and the influence on ovarian~     reserve after using uterine artery embolization during cesarean delivery.~   "
17809|NCT02824237|"~     Background:~      The increasing effect of environmental, occupational and climate change poses serious global~     threat for public health. More than half of the world's population, including around 85%~     people in Bangladesh, are exposed to household air pollutants (HAP). Environmental~     consequences of climate change are among the highest. Little evidence is available on the~     effects HAP on cardiopulmonary outcomes in low-income populations. Same is true for~     occupational health and climate change. The investigators will evaluate the effects of HAP~     on cardio-pulmonary and markers of immune function among non-smoking individuals. The~     investigators will also conduct two pilot studies to explore health effects associated with~     working in the garments industry and that of temperature due to climate changes.~      Hypothesis:~        1. Preclinical measures of cardiovascular diseases and pulmonary function are associated~          with exposure level of house hold air pollution (HAP) (assessed through PM2.5, CO and~          BC concentrations)~        2. Stable biomarkers of immune function and inflammation are associated with exposure~          level of HAP.~        3. Use of improved cook stove reduces exposure to HAP and thereby improve pre-clinical and~          molecular measures of cardio-pulmonary and immune functions.~      Methods: The investigators will conduct a cross sectional study to assess the associations~     of HAP with preclinical makers of CVD among 600 non-smoking participants aged 25 to 65~     years. Biomass exposure will be assessed for PM2.5, carbon Monoxide (CO) and black carbon~     (BC) by collecting personal air samples for 24-hour. Blood sample will be utilized from a~     subset of 200 adult participants and 60 children aged 3-5 years for assessing immune~     markers. The study will be conducted in icddr,b and URB study site at Matlab and Araihazar~     respectively.~      After the cross sectional assessment, the investigators will conduct a pre-post intervention~     study to evaluate effectiveness of improved stoves in a subset of 200 homes. The~     investigators will measure the aforementioned markers after two years of cook stove~     installation. Finally, as pilot studies, health outcomes due to climate change (temperature~     change) and occupation (garment industry work) will be explored.~      Outcome measures:~      HAP will be assessed through PM2.5, CO and BC concentrations. Pulmonary function will be~     assessed through FEV1, FVC and FEV1/FVC. Preclinical makers of CVD will include RH-PAT, FMD,~     IMT, BAD, EKG and PFT. Markers of Immune function - proliferation of macrophage, dendritic~     cells (DC), neutrophils and T-cell, as well as macrophage derived cytokines (a panel of 17~     or 27 cytokines) in peripheral blood mononuclear cells (PBMC)~   "
17810|NCT02824224|"~     This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in~     new users of the 52mg levonorgestrel-releasing intrauterine device. Half of participants~     will receive a course of tamoxifen three weeks after insertion of the IUD, while the other~     half of participants will receive a course of placebo.~   "
17811|NCT02824211|"~     Purpose: To investigate the feasibility of a new oxygen delivery device, the Right Dose~     System (RDS). It delivers individualized boluses of oxygen during rest and exertion to~     maintain acceptable oxygen saturations.~      The procedures include: Enrollment of 10 patients, who are randomized to either exercise~     with their oxygen prescription followed by exercise with the RDS, or exercise with the RDS~     followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis.~     Each set of exercise will be separated by a 30 minute recovery session. Subjects will be~     adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will~     be above 18 years of age. Subject participation will last approximately 1 month. Subjects~     will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation~     program. Consent will take place in the pulmonary clinic, pulmonary function lab or~     pulmonary rehabilitation by trained study physicians. If Multi-center: N/A (single center)~     If Single center or investigator-initiated: 10 subjects will participate in the study.~   "
17812|NCT02824198|"~     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine~     dose administered 5 years after the completion of a 3-dose vaccination schedule.~      Primary Objective:~        -  To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GTMR) of~          a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in~          subjects from CYD 28 trial (subjects from Group 1 only).~      Secondary Objectives:~        -  If the primary objective of non-inferiority is achieved: To demonstrate the~          superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third~          CYD dengue vaccine injection in subjects from CYD28 trial (subjects from Group 1 only).~        -  To describe the immune responses elicited by the CYD dengue vaccine booster or placebo~          injection in subjects who received three doses of the CYD dengue vaccine in the CYD28~          trial in all subjects.~        -  To describe the neutralizing Abs levels of each dengue serotype post-dose 3 (CYD28~          subjects) and immediately prior to booster or placebo injection in all subjects.~        -  To describe the neutralizing Ab persistence 6 months, 1 year and 2 years post booster~          or placebo injection in all study subjects.~        -  To evaluate the safety of booster vaccination with CYD dengue vaccine in all study~          subjects.~   "
17813|NCT02824185|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the~     second in terms of mortality. At an early stage, which is based on a low number and size of~     liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative~     treatment can be performed, i.e. liver transplantation, surgical resection, or~     thermo-ablation. These treatments can lead to severe complications, so patients benefiting~     from them must be carefully selected. The correct identification of all HCC lesions at the~     time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis~     but its field of exploration is limited to the upper abdominal area and its sensitivity~     decreases for nodules of less than two centimetres. Such lesions could actually be HCC that~     will cause early post-operative progression.~      Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide~     prognostic information but impacts initial staging in less than 5% of cases. However, PET~     with fluorocholine (FCH), available in France since 2010, could detect intra- and~     extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting~     patient management (e.g. 52% of patients in a small case study).~      FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC,~     combining in a single multimodality investigation the reference morphological imaging~     technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI~     is able to detect, in patients eligible for curative treatment, additional preoperative~     intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional~     imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.~   "
17814|NCT02824172|"~     The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose~     accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee~     and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually~     considered a benign pathology that cures in the majority of cases. However, in 5-10% of~     cases there is persistent residual pain in adulthood.~      The classic complication is the avulsion fracture of the tibial tuberosity in adolescents~     who continued his sports without restriction.~      The possible consequences are numerous including the presence of a free bone fragment at the~     insertion of the tendon originally described by Osgood the establishment of a genu~     recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying~     sport.~      The main two treatments are complete rest from sport activity or cast immobilization.~      The main objective is to compare these two technics according to the proportion of full~     sporting recovering at 12 months~   "
17816|NCT02824146|"~     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of~     pediatric patients undergoing general anesthesia. The collapse of dependent lung zones~     starts with anesthesia induction but can persist for hours or even days after surgery. Such~     anesthesia-related atelectasis has a number of negative clinical consequences such as the~     impairment of arterial blood oxygenation and lung mechanics as well as the predisposition~     for ventilator-associated lung injury. The adjustment of ventilator settings for preventing~     the occurrence of atelectasis and for reducing pulmonary complications remains~     controversial.~      Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children,~     including atelectasis of different origins. LUS has demonstrated its high sensitivity and~     specificity for diagnosing anesthesia-induced atelectasis in children.~   "
17817|NCT02824133|"~     The investigators will look for the presence of the fusion gene in all patients operated on~     for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the~     latter being sought in both routine and anomalies never co-existing.~      The hypothesis is that the rate of progression-free survival in grade IV gliomas and III~     without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of~     patients relapse before 6 months of treatment), must be with this new treatment 35% (primary~     endpoint).~      The main objective is the evaluation of disease-free survival at 6 months.~   "
17818|NCT02824120|"~     Laugh is more than visual and vocal behave, is always followed by a series of physiological~     changes, including contractions of musculoskeletal system, increase of cardiac frequency by~     catecholamine release and hyperventilation that promoves the increase of maximum breathing~     and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the~     quality of life of individuals can influence physiological and biochemical parameters of the~     human body.~   "
17819|NCT02824107|"~     The aim of this study is to identify groups of subjects at risk of recurrence in secondary~     prevention based on Psychosocial Factors.~      The aim is also to propose novel levers to reduce health inequalities in this population so~     as to develop new prevention strategies for neuro- and cardio-vascular health This study is~     based on data from questionnaires (Quality of life at work, perceived stress, perceived~     disease severity) and on behavior indicators (factors related to lifestyle: alcohol,~     smoking, obesity, sedentarity).~      Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study~     because of blood sample~   "
17820|NCT02824094|"~     Primary objective of this study is to allow access and evaluate the safety of crizotinib for~     patients in Japan with advanced NSCLC harboring a translocation or inversion involving the~     ROS1 oncogene.~   "
17821|NCT02824081|"~     Suicide is a major health problem that causes annually a million death worlwide. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition (personality, family history of SB…) and stressful conditions~     (early life adversity).~      Studies show that suicide ideations could favour inflammation and that depression is~     associated with an elevated inflammation.~      Recent evidences also suggest that inflammatory mediators play a critical role in SB.~      The aim of the study is to evaluate the inflammatory markers rate on depressed patients with~     or without personal history of SB.~      In the second part of the study, the relations between the rates of inflammatory markers and~     characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression~     of 5HT2B receptor will be investigated.~   "
17822|NCT02824068|"~     Long-term outcome in late-onset Pompe disease treated beyond 36 months (ATBIG-Pompe-Study),~     a multicenter, multinational, longitudinal, non-interventional observational study in~     subjects, at least 8 years old, diagnosed with late-onset Pompe disease retrospectively and~     prospectively collects data to understand clinical progression in terms of muscle and~     respiratory function, and clinical symptomology treated with alglucosidase alfa more than 36~     months in 100 subjects.~   "
17823|NCT02824055|"~     This is a multicenter, randomized, double-blind, placebo-controlled, three period crossover~     study to evaluate the effects of RO5545965 on the functioning of key brain circuitry~     involved in negative symptoms using functional magnetic resonance imaging (fMRI) and~     reward-based learning in stable participants with mild to moderate negative symptoms of~     schizophrenia treated with antipsychotics. Participants will be randomized to one of six~     different sequences during which each participant will receive three 3-week treatment~     courses with RO5545965 5 milligrams (mg), RO5545965 15 mg and placebo. Each treatment period~     will be separated by a washout period of 14 days. Total duration of study will be~     approximately 17 weeks.~   "
17824|NCT02824042|"~     Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of~     anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by~     concomitant administration of itraconazole in subjects with mesothelin-expressing advanced~     solid cancers~   "
17825|NCT02824029|"~     This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in~     the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial~     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth, by altering the environment around the tumor or by affecting the~     immune system.~   "
17826|NCT02824016|"~     Prospective, multicentric, comparative, non randomised, in current care.~      Primary objective:~        -  To evaluate the incidence of hypothyroidism in breast cancer patients treated by~          radiotherapy including the supra-clavicular area over a period of 5 years (60 months).~      Secondary objectives :~        -  To calculate the dose of irradiation received by thyroid gland during the treatment.~        -  To compare the rate of incidence of hypothyroidism in women who received a~          supra-clavicular irradiation (group 1)and in those who did not (group 2).~        -  To estimate and compare the rate of incidence of chronic thyroid lesions in the 2~          groups.~        -  To look for predictive factors of hypothyroidism de novo in group 1 women particularly~          regarding the dose-volume parameters.~        -  To propose recommendations for the thyroid follow-up after supra-clavicular~          irradiation.~   "
17827|NCT02824003|"~     The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic~     Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.~   "
17865|NCT02823509|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17866|NCT02823496|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
17828|NCT02823990|"~     This phase II trial studies how well TG4010 and nivolumab work in treating patients with~     non-small cell lung cancer that has gotten worse after one line of systemic therapy.~     Vaccines are made from a gene-modified virus, such as TG4010, may help the body build an~     effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab,~     interfere with the ability of tumor cells to grow and spread. Giving TG4010 and nivolumab~     together may work better in treating patients with non-small cell lung cancer that has~     gotten worse after one line of systemic therapy.~   "
17829|NCT02823977|"~     This study is designed to evaluate the addition of ketamine to dexmedetomidine as adjunctive~     therapies of severe alcohol withdrawal in medical ICU patients. Specifically, this study~     will assess whether the combination of ketamine and dexmedetomidine reduces the doses of~     conventional agents used for alcohol withdrawal while maintaining patient comfort and safety~     and will explore if the combination alters the expression of catecholamines in the serum~     over time.~   "
17830|NCT02823964|"~     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and~     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be~     formulated without enteric coating for administration either as a capsule or as a dosing~     solution dissolved in water or juice.~   "
17831|NCT02823951|"~     The purpose of this study is to evaluate the proportion of patients who demonstrate no~     medical need to discontinue therapy among DMT-naïve patients with relapsing forms of~     multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg~     bid based on real-world data.~   "
17832|NCT02823938|"~     In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among~     these substances, some, not prescribed in an indication related to cognitive function,~     however, will influence thereon.~      Several drug candidates with potential preventive effects have already been explored with~     little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other~     studies have suggested the existence of deleterious cognitive effects of certain substances~     (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of~     a limited number of drugs were analyzed, and most drugs have not been specific study in~     epidemiology.~      The study of this research theme has often been restricted by the limited size of the cohort~     of staff, not allowing the study of sometimes rare drug exposures, and poverty of the~     information collected on drug exposures. Thus, most studies focuses on families of molecules~     among the most prescribed. In addition, we now know that the pathophysiological process~     underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10~     years before the diagnosis of dementia. It is therefore essential to have a setback of~     several years between drug exposure and diagnosis of dementia to assess their role in the~     genesis and evolution of the disease.~      The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance~     and those of medicalization program of information systems (PMSI) for a sample of 550 000~     subjects enrolled in the general scheme of the insurance since 2004 and followed for a~     period of 20 years.~   "
17833|NCT02823925|"~     Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare~     inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase~     2 (MMP2) gene. Treatment options are limited. The investigators reviewed the outcome of~     patients affected with MONA and treated with intravenous bisphosphonates in the clinical~     Center.~   "
17834|NCT02823912|"~     The increased mortality from cardiovascular disease has a significant impact on the~     population, and the prevalence of these diseases it become one of the major problems, since~     it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease~     according ENSANUT; the above is attributed to the increase of diseases associated with an~     inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes~     mellitus (DM).~      The cholesterol is a major risk factor in the development of cardiovascular disease, and in~     turn increases the chances of death; however, the treatment of choice is based on changes in~     lifestyle, which for most people are difficult to maintain long-term. As for the drug~     therapy treated with drugs many people do not achieve their therapeutic goals, and therefore~     the inflammatory condition that underlies this disease remains.~      Recent studies have focused on the possible role of capsaicin in the inflammatory state~     through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory~     activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the~     expression of certain genes involved in this process induced. Capsaicin is a natural choice~     and well tolerated with few side effects limited to the gastrointestinal tract such as~     dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect~     of capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.~   "
17835|NCT02823899|"~     Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food~     contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and~     mortality in low income countries like Bangladesh. In our country, Cholera disease burden~     consists of both cholera outbreaks and endemic cholera comprising at least 300,000 severe~     cases and 1.2 million infections each year. To combat this situation, Vaccination against~     cholera has been proved effective both in endemic and epidemic settings. But, the WHO~     recommended Dukoral and Prequalified Shanchol are quite expensive for our country~     perspective. Therefore, locally manufactured OCV can improve the cost effectiveness and make~     it affordable for all. The hypothesis of this proposal is that Locally produced orally~     administered whole cell inactivated HL-OCV test formulations A and B are safe and~     immunogenic in adults and children in Bangladesh as compared to ShancholTM. The results of~     the study will allow us to understand the safety and immunogenicity outcome of the HL-OCV~     compared to Shanchol vaccine. The total sample size will be 840 healthy participants. 840~     healthy participants (360 adults, 240 Children and Adolescent and 240 young children) of~     18-45 years, 5- less than 18 years and 1 year to less than 5 years will be enrolled in the~     study. Children whose parents/guardians give voluntary consent will be enrolled in the~     study. The investigators will provide 2 dose of vaccine for three groups in 14 days~     interval. Test formulations will be locally manufactured and the comparator group will get~     Shanchol. The Investigators propose to collect three blood samples (Day 0, 14 and 28).~   "
17867|NCT02823483|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
17836|NCT02823886|"~     An intense inflammatory reaction is triggered by the ischemic injury during myocardial~     infarction. The inflammatory processes involved are complex and haven't been explored in~     detail in human patients. This inflammatory response can increase myocardial damage~     following reperfusion, leading to adverse remodeling and adverse events (heart failure,~     sudden cardiac death).~      Cardiac MRI can assess the size of myocardial infarction and many other parameters~     associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction.~      (However the association between biomarkers of inflammation and these imaging parameters is~     not known).~      There is very little data correlating imaging markers of myocardial injury to the~     biokinetics of inflammation biomarkers.~      In this study, the aim is to assess the relationship between the kinetics of specific~     inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis~     Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2),~     neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20~     acute mycardial infarction (AMI) patients.~   "
17837|NCT02823873|"~     The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff~     in pregnant and postpartum women who have either normal blood pressure or high blood~     pressure.~   "
17838|NCT02823860|"~     To access to good quality biological samples is a prerequisite for high level translational~     research. The BIG-RENAPE study has been established by the French hyperthermic~     intraperitoneal chemotherapy centers involved in the management of peritoneal surface~     malignancies.~      The main BIG-RENAPE study aim is to create a large multicentric and prospective repository~     for biological and tissue samples, which will provide a source of materials for a wide array~     of health related research studies - BIG-RENAPE Biobank-based research: i) validating known~     and promising biomarkers; ii) identifying new predictive and prognostic factors; iii)~     evaluating the impact of current health care strategies; iv) standardizing diagnostic and~     therapeutic management through guidelines; v) developing new drugs.~      The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing,~     storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue~     (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of~     diagnostic and therapeutic care. The patient and his derivates are anonymized and registered~     in a national web database reporting disease status, treatments, surgical procedures,~     pathological diagnosis, quality of life's assessment and long term follow-up. All~     participants have given their informed consent before any sample. The BIG-RENAPE study was~     approved by the local Ethical Committee, based on the assessed compliance to French~     regulatory rules.~   "
17839|NCT02823847|"~     The goal of this clinical research study is to learn how a new method for performing oral~     (mouth) exams can help doctors check for suspicious lesions (called premalignant and~     malignant oral lesions [PMOL]) in the mouth of HIV-infected smokers.~   "
17840|NCT02823834|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study~     to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed~     in the European Union (EU). These types of studies are required by regulatory authorities~     for all THA devices that do not have medium to long-term clinical evidence available at the~     time of gaining approval to market in the EU. This study has been designed in accordance~     with the medial device directives (MEDDEV) 2.12/2 rev 2.~   "
17841|NCT02823821|"~     This global study will assess the effect of randomising dialysis sites to one of two default~     dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major~     cardiovascular events and death in patients receiving maintenance haemodialysis.~   "
17842|NCT02823808|"~     All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo~     group (control) after intensive COAD treatment based on identical protocol.~        -  All subject will be managed with once daily, fixed dose, single tablet treatment based~          on the study protocol, and followed-up for 104 weeks.~        -  Any group of subjects who fail to reach glycemic target with single tablet treatment,~          subject will be treated with rescue medication and stopped regular observation.~   "
17843|NCT02823795|"~     This study evaluates if motivational interviewing sessions aiming to motivate recently~     discharged patients with either chronic obstructive pulmonary disease or congestive heart~     failure to be active in post-discharge self-management can reduce re-hospitalization rates.~   "
17844|NCT02823782|"~     Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for~     consultation, among the most frequent, in general or pediatric medicine. Among the different~     clinical forms of instability, ADHD appears to be an especially disabling condition for the~     development of the child, both in psychomotor, cognitive, emotional and relational aspects.~     Further, a significant link between ADHD children and some children with High Potential (HP)~     is observed. HP children show overall ahead cognitive developments compared to children with~     the same age. In these children, as well as in children with ADHD, an attention~     vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits~     that significantly contrasted with some of their cognitive skills. Regarding the HP, the~     hypothesis is that children with significantly heterogeneous results (Complex) to the~     Wechsler IV scales are affected by this shift, and hence, by the difficulty of a~     differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that~     are more homogeneous (Laminar).~      The goal of this work was to study a population of 80 children aged from 8 to 12 years (20~     subjects per group) to evaluate the functional and structural brain development by:~        -  Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations,~          involving attention, working memory and semantic processing, and emotional~          stimulations,~        -  fMRI acquisitions at rest (without activation),~        -  diffusion tensor magnetic resonance imaging (DTI) acquisitions,~        -  3D anatomic acquisitions. Identification of developmental differences in certain~          cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or~          functional networks preferentially used by one or other of these groups, will help to~          better understand this disease, and to improve the differential diagnosis in order to~          implement a more appropriate and personalized management of the patients via new~          therapeutic strategies.~   "
17868|NCT02823470|"~     The study will evaluate the impact of smart adherence technology for monitoring on~     lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with~     Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane~     Conductance Regulator (CFTR) mutation.~   "
17869|NCT02823457|"~     This study implement a values-based motivational interviewing (VBMI) intervention to promote~     treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30~     Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis~     C virus (HCV) infection.~   "
18092|NCT02820519|"~     Loxapine is an antipsychotic drug approved for the treatment of schizophrenia in several~     countries including the United States. In animal studies in mice, loxapine reduced~     neuropathic pain. Hence, in a proof-of-principle and dose-escalating study the tolerability~     and analgesic efficacy of loxapine will be evaluated in patients with neuropathic pain.~   "
17845|NCT02823769|"~     Despite the advances in adhesive restorative techniques and materials, dental caries still~     remains a critical concern even today. In addition, recurrent caries related to microleakage~     is a common mode of failure of directly placed resin composite restorations. Resin~     composites are particularly susceptible to recurrent caries due to polymerization~     contraction and also imperfect adhesion of restorative to tooth tissue. Thus, strong durable~     bond between adhesive restoratives and tooth tissue and increasing the resistance of teeth~     to acid by encouraging the development of remineralization are essential to withstand~     secondary caries. Fluoride has been documented as a major contributing factor for the~     decline in the incidence of dental caries and also it has been accepted as an agent in the~     prevention of caries. Giomers are a new group of anhydrous resin based direct adhesive~     restorative materials based on the filler technology (PRG) have both advantages of glass~     ionomers namely, fluoride release and recharge, and resin composites with excellent optical~     and mechanical properties. The chemistry of Giomer materials facilitates fluoride ion~     release with the potential for a lower incidence of recurrent caries that was accepted as a~     major factor to retreat a resin restoration. Limited number of studies is available on their~     fluoride release, and polishability, as well as clinical survival.~      The objective of this controlled clinical trial is to evaluate the clinical performance of~     restorative material SI-R21204 resin composite versus a nano-hybrid resin com-posite~     materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40~     patients are recruited to the project which is carried out at the School of dentistry,~     Istanbul Medipol University, Turkey.~   "
17846|NCT02823756|"~     The primary purpose is to examine the impact that physical therapy (PT) interventions,~     including manipulations, have on physical activity levels outside of the clinical~     environment in persons with low back pain (LBP) as measured both objectively with an~     accelerometer and subjectively with questionnaires.~      The secondary purpose is to determine if a relationship exists between objective physical~     activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk~     distance, lower extremity muscle endurance.~      The tertiary purpose is to assess the predictive value that a standing manual lumbar~     unloading technique has for relief of pain following manipulation~   "
17847|NCT02823743|"~     The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with~     placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy~     is detected on transvaginal ultrasound (around gestational week 6+) and continues to week~     35/36. The study is a single center, randomized, placebo-controlled, double blind and~     stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are~     enrolled, 200 in each arm aspirin / placebo.~   "
17848|NCT02823730|"~     To compare the incidence of major adverse cardiac events among a series of patients~     receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls~     who have received the Promus Premier drug-eluting stent with durable polymer.~   "
17849|NCT02823717|"~     Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the~     series), and are a source of potentially serious complications, even long time after~     delivery (especially disorders of anal continence, psychological trauma). If a number of~     risk factors are well described, the support arrangements at the time of delivery and the~     characteristics of the review Proctological remote delivery and its relationship to the~     clinical status of patients is little known and rarely studied.~      In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients~     with a diagnosis of severe perineal tear was made are taken following load with common~     rules, both for the immediate repair for the remote monitoring. Patients of both sites are~     indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.~      The same support on both sites allows to consider the creation of a relatively homogeneous~     cohort in terms of support and consider an important recruitment. Moreover, the geographical~     proximity of the inclusions sites (maternity) with proctology service is likely to limit the~     risk of lost sight of.~   "
17850|NCT02823704|"~     The study ia aiming to the assessment of Mid-Regional proadrenomedullin (MR-proADM) as a~     novel biomarker that can provide accurate short-, mid- and long term prognostic information~     in the triage and multi-dimensional risk assessment of patients in the Emergency Department~     (ED). A clinical algorithm with predefined MR-proADM cut-off values: <0.75 nmol/L (low~     risk), 0.75 nmol/L≥ and ≤ 1.5 nmol/L (intermediate risk); >1.5 nmol/L is pre-defined. Based~     on these cut-off values, a prespecified algorithm aiming to predict i) reduction of~     hospitalization in the ward/ICU and increase of out-patient treatment (rule-out of risk);~     and ii) reduce adverse complications (identify patients at risk) will be applied and~     compared with the initial clinical decision.~   "
17851|NCT02823691|"~     This is a Pilot, One-arm, Open-label, Prospective Study to evaluate Safety of Lanreotide 120~     mg ATG in combination with Metformin in patients with advanced progressive GI or lung~     carcinoids.~      The patient population will include patients with a histologically documented diagnosis of~     Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and~     lung NET carcinoids.~   "
17852|NCT02823678|"~     This study will enroll 100 patients scheduled to undergo a pancreatectomy.~      The primary objective is to develop a scoring system using pancreatic volume measured by CT~     scan and intraoperative measurements of the pancreas parenchyma to predict the onset of~     diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with~     pre-existing diabetes to see if their diabetes worsens or improves.~   "
17853|NCT02823665|"~     The purpose of this study is learn the effect of gastric bypass surgery and sleeve~     gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after~     eating.~   "
17854|NCT02823652|"~     This research trial studies how well pre-test genetic education and remote genetic~     counseling works in communicating tumor profiling results to patients with advanced cancer.~     Web-based genetic education before receiving tumor profiling results and remote genetic~     counseling for patients with potential germline mutations may increase genetic knowledge and~     reduce distress for patients with advanced cancer.~   "
17894|NCT02823132|"~     The aim of this study is to investigate levels of a protein, mannose binding lectin, in~     patients with acute leukemia who develop or not an invasive fungal infection.~   "
17895|NCT02823119|"~     The aim of this study is to evaluate the effect of hysteroscope diameter on the pain~     experienced by nulliparous patients undergoing diagnostic office hysteroscopy.~   "
17855|NCT02823639|"~     Impairments of cognition are a core, severely disabling feature of schizophrenia leading to~     poor long-term outcome with no established treatment available.~      Particularly impaired executive functions (e.g working memory) are frequently observed and~     are consistently associated with reduced activation of the dorsolateral prefrontal cortex~     (dlPFC). Deficits in those functions have been shown to be closely related to negative~     symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion~     that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.~      Noninvasive brain stimulation like tDCS can enhance executive functions like working memory~     in healthy subjects as well as in patients. To identify the optimal parameters for this~     intervention in patients with schizophrenia, the investigators first test the effects of~     different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality~     (left, right) on working-memory performance (nback task) in a sham-controlled cross-over~     design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be~     registered with electroencephalography (EEG).~      These experiments will provide reliable data for an evidence-based development of new~     clinical interventions to improve treatment of cognitive deficits in patients with~     schizophrenia and thus enhance schizophrenia prevention and recovery.~   "
17856|NCT02823626|"~     Primary Aims~        1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute~          decompensated heart failure patients.~        2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in~          causing volume loss and symptom relief in patients with ADHF treated with high-dose~          spironolactone.~      Secondary Aims~      1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal~     function.~   "
17857|NCT02823613|"~     The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is~     reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is~     upregulated in conditions with low salt.~   "
17858|NCT02823600|"~     The purpose of this research study is to look at retinal abnormalities in outpatient renal~     dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.~   "
17859|NCT02823587|"~     The purpose of this study is to assess the effect of pulmonary rehabilitation on the~     transport of secretions, inflammation and respiratory resistance, and its repercussions on~     the quality of life in patients with bronchiectasis.~   "
17860|NCT02823574|"~     A study in patients with metastatic or recurrent squamous cell cancer of the head and neck~     to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate~     714)~   "
17861|NCT02823561|"~     Obesity is one of the greatest public health challenges of the 21st century. Its prevalence~     has tripled in many countries of the European Region since the 1980s, and the numbers of~     those affected continue to rise at an alarming rate. In addition to causing various physical~     disabilities and psychological problems, excess weight drastically increases a person's risk~     of developing a number of noncommunicable diseases including cardiovascular disease, cancer~     and diabetes, in association or not to metabolic syndrome. The risk of developing more than~     one of these diseases (co-morbidity) also increases with increasing body weight. Every year~     a growing number of patient tend to suffer of more severe obesity and difficulty in losing~     weight even with a restricted diet and exercise.~      Garcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties;~     new evidence point out some promising effects in the prevention of lipogenesis and the~     promotion of lipolysis . Currently in the scientific literature there is only one paper, by~     Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet.~     This work has demonstrated a significant reduction in weight loss , compared to the placebo~     group,due to the use of Garcinia mangostana.~      Aim of the present study is the evaluation of safety and efficacy of weight loss in severe~     obese patients. Also cardiometabolic parameters and flogosys serum indicators will be~     evaluated before and after 6 month therapy of low calory diet alone or in association with~     Garcinia mangostana extract.~   "
17862|NCT02823548|"~     PICASSO has been designed to demonstrate that combination therapy with CS/GH has superior~     efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to~     100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with~     symptomatic hand osteoarthritis.~   "
17863|NCT02823535|"~     The overarching objective of this proposal is to conduct a randomized trial to evaluate the~     effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance~     abuse prevention and well-being enhancement program designed specifically for military~     personnel. Iwin provides an innovative, tailored mobile application using best practices in~     behavior change science and innovative technology to assist military personnel in preventing~     substance abuse and enhancing well-being by providing them with the most appropriate~     intervention content at the right time. It integrates Transtheoretical Model of Behavior~     Change based tailoring, in app messaging, stage of change matched activities, and engaging~     game-like features in a cutting edge multiple behavior change program. The efficacy of the~     Iwin program will be determined by tests of statistical significance indicating that~     participants in the Treatment condition had lower scores on an index of substance use and~     other behavioral risks. The overall design is a 2 group (treatment and control group) by 3~     Occasions with repeated measures across occasions.~   "
17864|NCT02823522|"~     Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related~     diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac~     disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of~     sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during~     elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC)~     challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest~     that wheat components other than gluten can cause the symptoms, and therefore the term~     non-celiac wheat sensitivity (NCWS) has been proposed instead of NCGS. While it is well~     known that CD is a long-life condition and a strict adherence to the gluten-free diet must~     be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the~     researchers published a retrospective study, including 276 patients with irritable bowel~     syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during~     a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many~     of these patients are still following a wheat-free diet, and B) which percentage was still~     suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.~   "
17870|NCT02823444|"~     To systematically develop, test, and refine peripheral vascular electrocardiography-gated~     fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial~     disease without gadolinium contrast.~      To test prospectively the accuracy of fast spin echo in peripheral arterial disease~     patients, compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance~     angiography. Additionally, as a substudy of this project, we will compare our fast spin echo~     approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as~     time-of-flight and steady-state gradient echo imaging.~      The overarching goals of our research are to develop and validate a peripheral magnetic~     resonance imaging technique that accurately depicts anatomy and disease without exposing~     patients to exogenous contrast material and its associated risks.~   "
17871|NCT02823431|"~     The purpose of this study is to evaluate how urethral analgesia impacts voiding efficiency~     in healthy women. The investigator hypothesizes that anesthetizing the urethral with~     lidocaine gel will decrease voiding efficiency as measured by standard bladder testing~     (urodynamic testing).~   "
17872|NCT02823418|"~     Postpartum depression (PPD) affects approximately 15% of women during the first year after~     giving birth, and is common across cultures. The etiology of postpartum depression is not~     totally clear. The severe pain experienced during childbirth was reported to be associated~     with the development of postpartum depression. The purpose of the present study is to~     evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum~     depression.~   "
17873|NCT02823405|"~     The goals of this protocol are 1) to investigate the safety and tolerability of X4P-001 in~     combination with Keytruda® (pembrolizumab) in patients with advanced melanoma, and 2) to~     assess serial biopsies of melanoma tumor lesions obtained throughout the study for~     inflammatory and tumor cell infiltrates. After completion of study treatment, patients with~     resectable disease will undergo surgery, unresectable patients may continue on pembrolizumab~     as standard of care.~   "
17874|NCT02823392|"~     Unanticipated difficult airway comprises of unexpected difficult bag mask ventilation or~     unforeseen difficult laryngoscopy. The incidence of difficult laryngoscopy or unanticipated~     difficult intubation in children was varied from 1.2 %to 4.77% depending on general or~     specific population and type of surgery. The known risk factors of difficult intubation in~     children were young age, associated syndrome or congenital abnormality and obstructive sleep~     apnea. Moreover, the predictors of difficult laryngoscopy by physical examination were~     associated with short interincisors distance, high frontal plane to chin distance, short~     thyromental distance and Cormack & Lehane classification 3 or 4. However, little knowledge~     is known regarding difficult bag mask ventilation in children. The incidence of difficult~     bag mask ventilation was 6.6% according to the single study. A few study reported the~     independent risk factor of difficult bag mask ventilation in children which were young age,~     obesity, use of neuromuscular blocking agent and airway surgery. In addition, the~     association between difficult bag mask ventilation and difficult intubation are still~     unknown. To understand more of difficult bag mask ventilation in children and~     factor-association may reduce incidence of morbidity and mortality by identifying difficult~     airway, preparing personnel and equipment tool in order to improve clinical outcome in~     pediatric anesthesia. The objectives of the study were to determine the predictors of~     difficult bag mask ventilation and the association with unexpected difficult intubation in~     children who came for elective surgery in tertiary care hospital of southern Thailand.~   "
17875|NCT02823379|"~     The purpose of this project is to test a 12-month, culturally relevant, Smartphone-delivered~     PA program to improve and maintain high physical levels and reduce cardiometabolic disease~     risk among obese AA women.~   "
17876|NCT02823366|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation However, about 40% of~     patients do not respond to UDCA optimally as assessed by known criteria for biochemical~     response. Those patients represent the group in need for additional therapies, having~     increased risk of disease progression and decreased survival free of liver transplantation.~     Both lab research and some clinical studies suggest that fenofibrate could improve~     cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary~     secretion and anti-inflammation effect. Here we start a random, open and parallel clinical~     research to explore the effect of fenofibrate in the PBC treatment.~   "
17877|NCT02823353|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC)~     approved by US and European drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in~     patients with PBC improves serum liver biochemistries and survival free of liver~     transplantation However, about 40% of patients do not respond to UDCA optimally as assessed~     by known criteria for biochemical response. Those patients represent the group in need for~     additional therapies, having increased risk of disease progression and decreased survival~     free of liver transplantation. Both lab research and some clinical studies suggest that~     fenofibrate could improve cholestasis in multiple ways including reduce of bile acid~     synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a~     random, open and parallel clinical research to explore the effect of fenofibrate in the PBC~     treatment.~   "
17878|NCT02823340|"~     Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment.~     Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and~     photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and~     24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients~     before and after treatment. The satisfaction and adverse reactions of the research~     participants were recorded at every follow-up visit.~   "
17879|NCT02823327|"~     This research trial studies clinical factors and gene expression analysis for prognosis in~     tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary~     effusion lymphoma. Gathering health information over time and studying samples of tissue~     from patients in the laboratory may help doctors learn about the prognosis of patients with~     AIDS-related primary effusion lymphoma.~   "
17880|NCT02823314|"~     Nausea and vomiting are two of the side effects associated with the most common~     antineoplastic chemotherapy treatments. The Medical Taping Concept (MTC) is an economical~     technique, easy to apply. This is a technique that may help reduce nausea and vomiting after~     application of chemotherapy in cancer patient.~   "
17881|NCT02823301|"~     The main purpose of this study is to evaluate the effectiveness and the maintenance of a~     behavior change program called VAMOS (Active Life Improving Health) Program on physical~     activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/~     Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil,~     defined according to environmental and income characteristics. Therefore, initially all~     geographic areas around the HC will be visited to classify the public places as favorable~     (with the presence of spaces for the practice of PA) and unfavorable environmental (do not~     have spaces for physical activity). Thereafter, four HC will be selected: high income + high~     environmental quality index, high income + low environmental quality index, low income +~     high environmental quality index, low income + low environmental quality index. In each HC,~     the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS~     group and control group. The participants that will be assigned to the VAMOS group will~     participate in a behavioral change program aimed at motivating changes in physical activity~     and eating habits during five months (12 meetings - six weekly meetings and six fortnightly~     meetings), while the control group will receive one educational lecture regarding lifestyle~     changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and~     will be mediated by the physical education professional previously trained. The Program will~     be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and~     maintenance. The effectiveness will be assessed from measurements of physical activity,~     eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid~     profile before and after five months of intervention. The implementation will be assessed by~     identifying the extent to which the program will be conducted as planned. The maintenance~     will be estimated from revaluations of all outcomes, as measured before and after the~     intervention, six months and one year after the end of the program.~   "
17882|NCT02823288|"~     South Africa has one of the highest rates of violence towards women globally. However,~     little is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an~     intervention that targets men as individuals, groups, and community members in a peri-urban~     setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the~     intervention condition or a control group. By speaking to men at baseline, 12 months, and 24~     months, investigators will learn whether violence and other health behaviors shift over~     time. Alongside the trial, qualitative research will explore how the intervention took place~     and why participants may change attitudes or behaviors.~   "
17883|NCT02823275|"~     Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical~     situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need~     surgical treatment. Both cast immobilisation and functional treatment have proved to be~     reliable postoperative treatment regimes. Insight into the quality of life and the level of~     pain is necessary to determine if these treatments can be related to higher patient~     satisfaction and earlier resumption of daily activities and work.~      Objective: The aim of this study is to examine two postoperative treatments for surgically~     corrected ankle fractures. Postoperative, direct functional mobilisation is compared to~     short term plaster cast fixation. The focus of this study is on quality of life, pain and~     the use of pain medication, and resumption of work and daily activities.~      Main study parameters/endpoints:~      Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain~     disability index), complications~   "
17884|NCT02823262|"~     The purpose of this research study is to evaluate a decision aid to help women aged 70 and~     older decide on treatment for their breast cancer.~   "
17885|NCT02823249|"~     With this study the investigators investigate the effects of amino acids (tryptophan,~     leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.~   "
17886|NCT02823236|"~     The aim of the study is to assess the efficacy and safety of the combination of~     intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical~     pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the~     treatment of keloid scars in adults. The duration of this three-arm clinical trial will be~     12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences.~     The estimated number of persons to be recruited and randomized for the study is 102.~   "
17887|NCT02823223|"~     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr~     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous~     emphysema patients in a controlled trial design setting.~   "
17888|NCT02823210|"~     Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common~     natural evolution: a chronic phase, characterized by a major risk of vascular events,~     followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN~     include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer~     entities. During the past years, CML became a paradigm for targeted therapy and personalized~     cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many~     other mutations, opened similar perspectives. However, several questions remain to be~     answered in MPNs regarding the clinical implication of these major scientific discoveries:~     what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of~     complications and progression? Can these new biomarkers be used in the perspective of a~     personalized therapy of MPNs? his project will focus on the qualification of a series of~     known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with~     well-annotated samples~   "
17889|NCT02823197|"~     The purpose of this study is to determine whether a theory- and evidence-based intervention~     aiming to promote active transport for short distance travel among older adolescents is~     effective in increasing attitude, subjective norm, self-efficacy, awareness and habit~     towards active transport, and intention to use active transport after obtaining a driving~     license.~   "
17890|NCT02823184|"~     The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive~     for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).~   "
17891|NCT02823171|"~     A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the~     Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT]~     Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral~     Administration in Healthy Subjects~   "
17892|NCT02823158|"~     Deep brain stimulation (DBS) is an established treatment for advanced complicated~     Parkinson's disease (PD). Several controlled randomized studies have given proof of an~     advantage for operated patients as compared to medically treated patients in terms of motor~     outcome, activities of daily living and health status. However these studies have addressed~     mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared~     to best medical treatment (BMT) in a prospective randomized controlled trial in patients~     with complicated PD who are not good candidates for STN stimulation. The investigators aim~     assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.~   "
17893|NCT02823145|"~     This is an international, multicenter, open-label, long-term safety study of ZX008 in~     pediatric and young adult subjects with Dravet syndrome who have successfully completed 14~     weeks of treatment in the core study (ZX008-1501 and ZX008-1502).~   "
17896|NCT02823106|"~     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the~     safety and feasibility of super-selective intra-arterial administration of verapamil and~     citicoline immediately following successful endovascular thrombectomy as a potential~     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.~     This trial represents the first time that citicoline will be evaluated in human subjects as~     a superselectively administered neuroprotective agent administered in an acute time frame as~     an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to~     evaluate combinational therapy for acute stroke neuroprotection.~   "
17897|NCT02823093|"~     The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of~     thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic~     calcifications development. This is a biomedical research without health product,~     transversal and monocentric study which compares the aortic calcifications levels of two~     populations : one treated by VKA and the other which has never been treated by VKA.~   "
17898|NCT02823080|"~     To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte~     retrieval (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome~     (OHSS) after gonadotropin- releasing hormon agonist induction protocol.~      Patients & Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound~     scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients~     underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25~     mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value~     (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites~     grading were re-evaluated on Day-3, 6 and 8~   "
17899|NCT02823067|"~     The primary objective of this observational study is to describe the prevalence of pruritus~     and pemphigoid in nursing home patients. Secondary outcomes are the relationships of~     demographic factors and medical risk factors with pemphigoid, including dementia and~     neuropsychiatric symptoms, medication use and Karnofsky score.~   "
17900|NCT02823054|"~     Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is~     usually taking to restore coronary revascularization, and its dissection can lead to~     accidental or voluntary pleural effusions. Respiratory complications are frequent, due to~     the drainage required. In this study, the investigators propose one-lung ventilation to~     facilitate artery grafting and surgical procedure. The investigators will include all adult~     patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in~     a prospective, controlled, randomized and monocentric study. The main objective is to~     demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined~     by presence of drainage and/or pneumothorax on X-ray chest in the ICU.~   "
17901|NCT02823041|"~     This is a confirmatory randomized controlled trial of the efficacy of a novel intervention~     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the~     same systematic cognitive training alone. Treatment occurs for 6 months after randomization,~     with a followup assessment at 12 months. The investigators hypothesize that combining~     neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical~     exercise will produce neurotrophin increases and cognitive and functional improvements, even~     relative to cognitive training alone. The investigators target the period shortly after a~     first episode of schizophrenia to maximize the generalization of cognitive improvement to~     functional outcome, before chronic disability is established.~   "
17902|NCT02823028|"~     Tweet2Quit is an innovative smoking cessation intervention that combines real-time online~     peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the~     investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.~   "
17903|NCT02823015|"~     Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem,~     affecting between 25 and 50% of patients. Several factors are associated with the~     development of PPBCS, including acute postoperative pain. The analysis of pain trajectories~     through mixed model modeling is an alternative to static pain measures, improving precision~     and providing information on the time course of pain resolution. Our aim was to investigate~     if the characteristics of pain trajectories during the first postoperative week are~     correlated with the persistence of pain 3 months after breast cancer surgery.~   "
17904|NCT02823002|"~     This study will collect data from multiple academic institutions. The primary objective for~     part A of this study is to determine the impact of anesthetic injection rate and temperature~     on pain perception during dermatologic procedures, and the objective for the part B of this~     study is to determine if buffering of the anesthetic solution alters pain perception.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
17905|NCT02822989|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and~     musculoskeletal pain is one of the most common symptoms. This study will investigate whether~     transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This~     study will additionally investigate the biologic effects of vagus nerve stimulation on~     inflammation. It will be the first clinical study using one of the body's own pathways of~     modulating the immune system and inflammatory response, the cholinergic anti-inflammatory~     pathway, in SLE.~   "
17906|NCT02822976|"~     Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac~     surgery, septic and critically ill patient population. It is a promising test to understand~     the complex relationship between glycemia, diabetes and outcomes in patients admitted to the~     intensive care unit.~      Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is~     associated with poor outcomes.~   "
17907|NCT02822963|"~     Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH~     symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP),~     is recommended. Although the procedure is quit safe, these old men often take anticoagulants~     and antiplatelets to control cardiovascular diseases, which arose some concerns for their~     bleeding risk. The management of anticoagulation in patients undergoing surgical procedures~     is challenging because interrupting anticoagulation increases the risk of thrombotic events.~     At the same time, surgery and invasive procedures have associated bleeding risks that are~     increased by the anticoagulant administration. Now, the recommendation about anticoagulants~     and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore,~     there is no relative studies done in Taiwan population, which calls for further~     investigation.~   "
17908|NCT02822950|"~     The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in~     the Intensive Care Unit (12). This study will include medical and post-surgical patients who~     develop an infection where Avycaz can be utilized. Since these patients will have variable~     PK parameters, the investigators will also analyze (time-kill) these serum concentrations~     (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to~     determine microbiologic activity of Avycaz in critically ill patients with variable~     characteristics. Monte-Carlo simulations will also be conducted against clinical ICU~     isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK~     parameters.~   "
17909|NCT02822937|"~     This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive~     measurements to two short-acting cognitively active pharmacological agents. The participants~     will receive a placebo, and two pharmacological agents in a randomized order for three~     in-clinic study days. During each study day in the clinic, the participants will use~     Project: EVO Monitor and another cognitive task through the day.~   "
17910|NCT02822924|"~     The objective is to evaluate the clinical effectiveness and safety of PAE in treating~     patients with BPH.~   "
17911|NCT02822911|"~     Alcohol misuse affects 5 million people in France. Even though the elderly are also~     concerned by this pathology, there is not much information about chronic alcohol misuse of~     this population in particular.~      Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV)~     and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a~     biological marker of alcohol misuse, the specificity of the CDT is known to be superior to~     the GGT as well.~      However, when it comes to the elderly, alcoholism diagnosis tools are based on research of~     younger populations.~      This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the~     elderly.~   "
17912|NCT02822898|"~     The prescription of intravenous maintenance solutions - although widespread - lacks~     important data on the optimal sodium and potassium content, which has given rise to an~     important debate in the scientific literature. Our study compares two different infusion~     fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized~     crossover design over two 48 hour periods during which subjects are not allowed to eat or~     drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of~     potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both~     solutions are administered at 25 mL/kg of ideal body weight, as recommended by current~     guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The~     primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than~     hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine~     and serum, clinical parameters and bioelectrical impedance analysis.~   "
17913|NCT02822885|"~     This study was to investigate the diagnostic value of ultrasonography and blood flow~     measurements in uterine arteries and spiral arteries by transvaginal color Doppler~     ultrasonography in the detection of the endometrial pathology in women with postmenopausal~     bleeding.~   "
17914|NCT02822872|"~     Infertile couples who come for evaluation and treatment in IVF unit could be under~     psychological stress. Many authors in the past suggested that stress itself is one of the~     factors that directly influence fecundability rate. In couples treated in IVF unit, the~     investigators aim to measure chronic stress by measuring hair cortisol level (as a marker~     for chronic cortisol release) and by filling different questionnaires.~   "
17915|NCT02822859|"~     The study will assess three different nebulizers for use in methacholine challenge testing~     in order to determine if the Aeroneb Solo would make a suitable replacement for the~     long-used and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will~     be compared to evaluate whether current guidelines for the methacholine challenge should be~     updated for superior standardization.~   "
17916|NCT02822846|"~     The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to~     monitor the position of the intubation probe.~      The primary assessment criterion is of study the position of the intubation probe with two~     examinations carried out independently :~        -  sonography~        -  chest radiography~      A correct position of the intubation probe will be considered if there is :~        -  Highlighting of the extremity of the intubation probe in endo tracheal~        -  Highlighting bilateral lung sliding~   "
17917|NCT02822833|"~     Endometrial cancer is the most common gynecologic malignancy in developed countries and the~     second one in developing countries following cervical cancer. The primary treatment for~     endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with~     adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who~     have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial~     cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients.~     The primary purpose of the present study is the to investigate the feasibility of sentinel~     lymph node determination in endometrial cancer patients operated via conventional~     laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected~     prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph~     nodes will be removed and examined by frozen section. Afterwards, systematic pelvic~     lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3,~     metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes,~     paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to~     compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer~     patients.~   "
17918|NCT02822820|"~     This single-institution prospective randomized clinical trial will be performed at the~     Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and~     cervix cancer who will be operated for staging via laparoscopic approach will be included in~     the study. The included patients will be randomized to two groups before surgery. During the~     operation of first group instruments with advanced bipolar energy will be used during~     lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the~     operation will be performed by conventional bipolar energy forceps. The outcome parameters~     to be measured are intra-operative bleeding, duration of operation, intraoperative~     complications, postoperative pain score, postoperative complications, postoperative duration~     of hospitalization, late complications such as lymphocele formation and costs.~   "
17919|NCT02822807|"~     The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii~     is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is~     associated with secretion by the body both many antibodies against the bacteria but also~     against certain cells of the body (autoantibodies). These autoantibodies may have no effect~     or be associated with specific symptoms. Anti-Phospholipid antibodies are especially~     prevalent in the Q fever. Apart from this infection, they are associated with~     thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These~     conditions have also been described as complications during Q fever. In a retrospective~     preliminary work on Q fever, we have shown that the presence of high levels of IgG~     anti-cardiolipin was associated with the presence of valvular and the evolution to~     endocarditis. Such associations have a therapeutic involvement and must therefore be~     confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could~     be systematically proposed to patients with valvular disease of trans-thoracique ultrasound~     but IgG anticardiolipin high levels. Other special attention could be given to patients with~     high autoantibodies.~   "
17920|NCT02822794|"~     The primary objective of this study is to evaluate the antiviral efficacy, safety, and~     tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC)~     and ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) who have previously~     failed a direct-acting antiviral (DAA)-containing regimen.~   "
17921|NCT02822781|"~     Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency,~     flow) because currently treatment protocols available to us are with a limited efficacy. The~     assessment of the response to surgical treatment protocols and monitoring the become of~     patients treated with only drugs should allow investigators to identify the predictive~     patient's profile for the response. With this prospective data, this study would allow~     investigators to make a classification of Chronic rhinosinusitis.~   "
17922|NCT02822768|"~     The goal of this study is to examine patients undergoing incision and drainage of cutaneous~     abscesses to determine if routine packing of the abscess cavity affects the need for further~     interventions such as repeat incision and drainage, antibiotic administration or hospital~     admission.~   "
17923|NCT02822755|"~     The purpose of this study is to determine the effectiveness of an individualized video~     recording in improving adherence in home exercise programs for orthopaedic physical therapy~     patients.~      Specific aims:~      1. Evaluate whether individualized video recordings improve adherence with home exercise~     programs (HEP) as compared with conventional printed instructions measured by a self-report~     exercise log. (1-tail analysis)~   "
17924|NCT02822742|"~     The purposes of this study are to investigate the effect of intraocular pressure lowering~     efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle~     glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic~     solution.~   "
17925|NCT02822729|"~     The purposes of this study are to evaluate the long-term safety and intraocular~     pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of~     DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle~     glaucoma or ocular hypertension.~   "
17926|NCT02822716|"~     The objectives of this study are to study the safety and effect of IRE as a treatment for~     inoperable hepatic and pancreatic malignancy.~   "
17927|NCT02822703|"~     Tobacco use is one of the most significant cancer control and public health challenges in~     the US today. Half of all smokers in the US will attempt to quit tobacco each year, but~     fully 95% of those who attempt to quit will reverse this decision within 12 months and~     choose the transient, albeit immediately rewarding activity of smoking at the cost of much~     larger long-term rewards such as future health and long life. This project seeks to improve~     scientific knowledge of these decision-making processes and potentially improve the~     treatment of tobacco dependence by examining the feasibility of using a brain stimulation~     technique, repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of~     an existing evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment~     for medication resistant depression and is being examined as a treatment for a variety of~     other disorders. This study will utilize an intensity and duration of rTMS that is well~     within the safety parameters and similar in location and intensity to that used in previous~     studies with smokers to reduce cigarette consumption.~   "
17928|NCT02822690|"~     The aim of this study is to get insight in the quality of life at the end of life and~     quality of dying for patients died at the hospital in the department Groningen (the~     Netherlands).~      The primary endpoint is the quality of life at the end of life and the secondary endpoint is~     the quality of dying. Both according a numerical rating scale.~      An explorative analysis will be done for differences for the hospitals in Groningen, effect~     of using the Liverpool care Pathway for the dying, effect of using consultation by the~     palliative consultation team, effect of using the Hospice@UMCG intervention, correlation~     with the quality of life at the end of life and quality of dying according to nurses and~     doctors.~   "
17929|NCT02822677|"~     The investigators will conduct a cross-sectional study to discovery the distribution of IBS~     subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the~     investigators will also collect the serum, urine and stool samples of the participants to~     explore the host-gut microbiota metabolic interactions associated with IBS subtypes.~   "
17930|NCT02822664|"~     The main objective is to identify cerebral correlated of pedophilia using neuroimaging~     techniques.~   "
17931|NCT02822651|"~     Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey~     conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of~     subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency~     (<10ng/ml).~      Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the~     number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5~     million € in 2011, and with it the costs for health insurance. However, there is currently~     no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.~      We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate~     assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected~     through a self-administered questionnaire.~   "
17932|NCT02822638|"~     Ischemic heart disease is the leading cause of mortality in industrialized countries. ST~     elevated acute myocardial infarction is one of its most frequent and deadly manifestation.~     In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely~     reperfusion (primary percutaneous intervention) and significant progression in pharmacologic~     intervention.~      However, death and heart failure incidence after STEMI remain elevated: up to 20% at one~     year.~      Also, therapeutic management following international guidelines is standardized toward a~     one-size fits all therapeutic management.~      In order to continue improving myocardial infarction outcomes, there is a need to better~     understand and individualize therapeutic targets such myocardial reperfusion injury, post~     reperfusion inflammation, adverse left ventricular (LV) remodeling ….~      This knowledge will allow us to propose new therapeutic strategies and in the long run~     strive towards personalized medicine.~      The aim objective of this cohort of STEMI patients is to identify new biological markers of~     injury and prognosis.~   "
17933|NCT02822625|"~     QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component~     responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral~     neuropathic pain in non-diabetic adults either alone or in combination with other~     analgesics. Acute pain experienced during and after the procedure can be relieved by local~     cooling methods and oral analgesics but the pain remains intense. The hypothesis is that~     hypnosis via a standardized hypnotic message would increase the local tolerance of the~     treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm~     or refute this hypothesis.~   "
17934|NCT02822612|"~     Ophthalmology is among the most technology driven of all medical specialties, with advanced~     medical imaging devices - and specialised computer software - increasingly adopted for~     routine clinical use. While many such devices are capable of completing specific tasks, lack~     of usability prevents their widespread adoption (i.e., such devices are not easy to learn~     and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that~     are difficult to use expose patients to clinical risk as a result of human error during~     usage.~      With the introduction of a new medical technology, it is essential, therefore, to have a~     deep understanding of patients, what they need, what they value, their abilities, and also~     their limitations.~      Human factor and usability testing, also known as human factor engineering, deals with the~     formal study of people's interaction with their environment (in this case, the binocular OCT~     device). Structured, patient-centred, usability testing is essential to the design, clinical~     validation, regulatory approval, and widespread implementation, of all new medical devices.~     This is particularly the case for a putative binocular OCT system - a device intended for~     automated use in visually impaired, often elderly, populations. Although the binocular OCT~     is already at an advanced stage of hardware development, the EASE study will facilitate an~     iterative process of operating software and workflow modifications to optimize the device~     for use in these populations.~   "
17935|NCT02822599|"~     The goal of the study is to determine whether the use of Human Fibrinogen Concentrate~     (RiaSTAP) will decrease the need for component blood therapy in neonates and infants~     undergoing cardiopulmonary bypass.~   "
17936|NCT02822586|"~     The purpose of this study is to evaluate the cutaneous toxicity and treatment response~     associated with administering concurrent TSEB and brentuximab vedotin in patients with~     mycosis fungoides or Sézary Syndrome.~   "
17937|NCT02822573|"~     This study is to compare the safety and effects of donepezil (Aricept) or if it decreases~     memory loss after receiving chemotherapy for breast cancer.~   "
17938|NCT02822560|"~     The present clinical trial is performed in the field of vascular surgery. The aim of the~     study is the economical and clinical comparison of two different access ways to the femoral~     artery with intention of endovascular repair of aortic aneurysm. The usual access is a~     surgical cutdown to the femoral artery and is compared to a percutaneous access which is~     closed via a suture mediated device (Perclose ProGlide, Abbott).~   "
17939|NCT02822547|"~     Patients will receive Peginterferon alfa-2a according to the standard medical practice but~     the observation period is 12 weeks~   "
17940|NCT02822534|"~     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent~     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose~     study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in~     Type 2 Diabetes Patients .~   "
17941|NCT02822521|"~     The overall objective of this proposal is to implement a smartphone application (app) +~     population management system to monitor rheumatoid arthritis (RA) disease activity between~     scheduled physician office visits. The population management system includes: 1) a web-based~     dashboard that consolidates incoming patient-reported data using pre-programmed algorithms~     to identify increases in disease activity, and 2) the population manager, a trained~     individual who monitors the web-based dashboard and connects patients with their HCPs. The~     investigators central hypothesis is that the combined smartphone app + population management~     system will improve patient satisfaction and management of RA disease activity.~   "
17942|NCT02822508|"~     The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and~     efficacy versus placebo in adults experiencing non-idiopathic constipation.~   "
17943|NCT02822495|"~     This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA)~     partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV-associated~     viremia and disease for which there is no comparable or satisfactory alternative therapy to~     treat the patient's disease or condition. Patients must not be eligible to enroll in~     clinical trials designed to support the development and marketing approval of Atara~     EBV-CTLs.~   "
17944|NCT02822482|"~     The study consists of two distinct and sequential parts:~        -  A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination~          (copanlisib/cetuximab) and the RP2D~        -  A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended~          Phase 2 Dose)~      All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in~     association with Cetuximab.~   "
17956|NCT02822326|"~     The purpose of this study is to evaluate the safety and efficacy of chimeric antigen~     receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or~     refractory CD19+ acute Leukemia.~   "
17957|NCT02822313|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17945|NCT02822469|"~     Background: Different therapeutic approaches have been proposed for the treatment of TMD.~     Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and~     phototherapy applications, are among the most common. The combination of local treatments~     and adjacent structures such as the cervical region have also been studied in this area. It~     is believed that the anatomic proximity, neuronal interconnections and convergent afferents~     from the trigeminal and cervical areas can lead the understanding of the relationship of~     these structures. In order to assess the effects of these different forms of treatment~     studies have used different resources such as diagnostic imaging and biological signals, in~     order to complement the clinical diagnosis. Infrared thermography has been one of the~     resource assessment in the literature and it is interesting and stands out from other~     methods because it is functional, non-invasive and inexpensive.~      Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles,~     severity, pain, range of mandibular motion and neck disability in TMD patients, before and~     after physical therapy applied to the cervical and thoracic regions.~      Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of~     indirect treatment on the thermography of the masticatory muscles, severity, pain, range of~     motion and neck disability in individuals with TMD. These will be randomized and allocated~     into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for~     Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI),~     Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).~      Statistical analysis: The temperature of the orofacial region, acquired through thermography~     is considered the primary endpoint and as a secondary endpoint will be the evaluation of the~     severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by~     pachymetry and neck disability by NDI.~      Statistical analysis: The normality of the data will be verified using the~     Kolmogorov-Smirnov test, which will be expressed as mean and standard deviation and/or~     median and interquartile range. Repeated measures analysis of variance of two factors, post~     hoc Bonferroni will be used for inter and intra-group comparisons. The significance level of~     p≤0.05 is set.~   "
17946|NCT02822456|"~     The aim of this study is to test the clinical effectiveness of IOE tube using individually~     customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when~     unconscious patients have no choice but tube feeding.~   "
17947|NCT02822443|"~     The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU)~     conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on~     self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on~     differential effects. Moreover, the mechanisms of change of both conditions are~     investigated.~   "
17948|NCT02822430|"~     For several decades, authors are interested in the existence and meaning of painful symptoms~     in a population of psychiatric inpatients. But, to date, studies specifically focused on the~     impact of pain in patient populations in psychiatric hospitals are few. More recently, a~     review of the literature highlights the difficulties of evaluation of pain in populations of~     psychiatric patients but also the complex interrelationships between painful symptoms and~     psychiatric diseases. The first national survey conducted among 172 health which evaluate~     pain and its management in the field of psychiatry concluded on the need to develop research~     in this area.~   "
17949|NCT02822417|"~     To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia~     and the effect of genetic variation in gDNA on the recovery time of postoperative~     anesthesia.~   "
17950|NCT02822404|"~     Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve~     renal toxic threats in children given their immature kidney. This toxicity is increased~     especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the~     available evaluation methods of the renal function could be very restrictive to perform on~     children. In this study, the investigators intend to test the use of the cystatin C as an~     effective and reliable biological marker of renal toxicity in children treated with~     cisplatin and / or ifosfamide.~   "
17951|NCT02822391|"~     Orofacial impairment following stroke frequently involves a reduced chewing performance and~     dysphagia. This study investigated the sensitivity of oral tissues following stroke and its~     potential impact on chewing efficiency.~      The following two Null-hypotheses (H0) were tested:~      i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy~     controls.~      ii. Intra-oral sensitivity is not correlated to chewing efficiency.~   "
17952|NCT02822378|"~     Postmenopausal women often seek non-pharmacologic interventions for the protection of bone~     health. Previous research in humans and rodents has indicated that dietary dried plum~     consumption may be beneficial for bone health, especially in postmenopausal women. However,~     it is unknown in what quantity dried plums need to be consumed to be of benefit and through~     what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study~     is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on~     bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal~     women. The investigators also seek to evaluate the mechanisms underlying the effects of~     dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated~     metabolites in the urine of postmenopausal women taking different doses of dietary dried~     plums. The investigators aim to further investigate the mechanisms of dried plum action on~     bone by measuring markers of bone metabolism in response to dried plum consumption.~   "
17953|NCT02822365|"~     This pilot study tests the pocket phantom tool in improving the accuracy of quantitative~     positron emission tomography/computed tomography (PET/CT) imaging of patients with solid~     tumors. The pocket phantom tool may help test the accuracy of the PET/CT scanner and~     indicate whether adjustments need to be made to get consistent information.~   "
17954|NCT02822352|"~     Colitis is inflammation of the large bowel and it is often caused by conditions known as~     ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated~     inflammatory response against the bowel - the body attacks the bowel. Patients who have had~     colitis affecting most of the large bowel for more than 8 years are at increased risk of~     cancer of the large bowel. In view of this, many national gastroenterology organisations~     have recommended that such patients have regular colonoscopies to detect pre-cancerous areas~     and even early cancer in the large bowel. Early detection of such areas, will lead to early~     treatment thereby reducing the risk of developing significant large bowel cancer. These~     regular colonoscopies are known as surveillance colonoscopies.~      Official international guidelines for surveillance in patients with ulcerative and Crohn's~     colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10~     centimeters and of any suspicious areas. Recent studies have shown that spraying dye such as~     indigo carmine (a type of food dye) helps highlight abnormal areas that could harbor~     pre-cancerous cells. This technique is time-consuming, and tedious. There are no set~     standards of what is considered a satisfactorily completed dye spray colonoscopy. The uptake~     of this technique in the UK has not been uniform. Therefore virtual chromoendoscopy has been~     studied as an alternative method to improve the detection of pre-cancerous tissue in~     patients with longstanding colitis.~   "
17955|NCT02822339|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
17965|NCT02822209|"~     The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of~     one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV.~     Controlling the timelines in a care program seems crucial to improve prognosis of lung~     cancer.~      The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care~     program for patients of thoracic oncology.~   "
17966|NCT02822196|"~     HYPOTHESIS~      Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block~     (PVB) for acute pain control after unilateral mastectomies.~      SPECIFIC AIMS~      Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in~     patients undergoing unilateral mastectomy~      Secondary aim To compare the onset and duration of block and dermatomes blocked in both~     groups To compare the need of post-operative rescue analgesia in both groups. To compare the~     development of chronic incisional pain in both groups Functional outcome with respect to~     daily activities.~   "
17967|NCT02822183|"~     This online survey presents capnography waveforms and asks the survey participants to give~     feedback about their interpretation of the patient status, both in the form of a score and a~     set of text to describe their interpretation.~   "
17968|NCT02822170|"~     The purpose of this small pilot study is to refine a combined intervention of IV amino acids~     and cycle ergometry in critically ill patients, and to gather preliminary data, before~     proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined~     intervention.~   "
17969|NCT02822157|"~     This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian~     tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard~     chemotherapy with the possibility of crossover at the time of progression.~   "
17970|NCT02822144|"~     In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients,~     65 % of whom keep long-term disability. Several multicentric randomized controlled trials~     have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke~     on functional disability, compared to a medical treatment alone (thrombolysis).~      The timeliness of revascularisation is an essential factor of good prognosis. This~     intra-arterial treatment, associated with thrombolysis if applicable, is the reference~     treatment of large-vessel occlusion. The stillness of the patient is required to control the~     safety of the recanalization. Currently, either a general anesthesia or a sedation can be~     performed.~      Several studies have shown a trend to superiority of the sedation but none was conducted~     with a high level of proof methodology.~      The aim of our multicentric randomized controlled trial is to compare sedation and general~     anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior~     cerebral circulation. The main outcome will be the efficacy on the functional neurological~     prognosis at 3 months.~   "
17971|NCT02822131|"~     High dietary phosphate intake in the general population is associated with a higher risk for~     developing kidney disease and cardiovascular disease with an increased overall mortality.~     Whereas the effects of high phosphate intake on general health become clearer, almost~     nothing is known about underlying mechanisms. More recently, the investigators and others~     found in animal models that FGF23 stimulates the renal NaCl cotransporter NCC, the target of~     thiazide diuretics, and that increased NCC activity may increase blood pressure. The~     investigators could also show that increasing dietary phosphate intake in mice, increases~     FGF23 and NCC activity within 3 days. Thus, the objective of this single-centre~     observational cross-over study including 20-45 year old healthy male probands is to~     elucidate the role of dietary phosphate on blood pressure regulation and renal handling of~     sodium chloride in healthy subjects. Further the impact of dietary phosphate intake on the~     regulation of phosphaturic hormones and other factors regulation blood pressure will be~     investigated. In addition, the investigators will examine whether phosphate intake modulates~     gut microbiome composition. The primary outcome in this study is the change in blood~     pressure in healthy subjects on low-phosphate diet compared to healthy subjects on~     high-phosphate diet. In addition, to assess changes in NCC activity as the main mechanism of~     phosphate-sensitive blood pressure regulation, renal sodium chloride excretion after~     administration of hydrochlorothiazide will be measured. The secondary outcomes of this study~     are: changes in renal phosphate, calcium and potassium excretion, changes in phosphate~     regulation hormones such as 25-OH-Vit. D, 1,25-(OH)2-Vit. D, PTH, FGF23, dopamine in plasma~     and urine, changes in plasma and urinary aldosterone levels, changes in~     sodium/chloride-cotransporter NCC and NaPi-IIa assessed from urinary exosomes, and changes~     in stool phosphate excretion and gut microbiome composition.~   "
17972|NCT02822118|"~     To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of~     IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was~     designed. Patients were applied for central random number and were given corresponding~     treatment according to inclusion sequences.The treatment group was administered the Chang'an~     I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo,~     150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.~   "
17973|NCT02822105|"~     The purpose is of this study is to assess the safety and tolerability of three dose levels~     of H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult~     subjects.~   "
17974|NCT02822092|"~     This is an observational neuroimaging treatment study. This study involves examining the~     neural circuitry of controlled treatment of patients presenting with a first-episode of~     psychosis with risperidone. Patients who present for treatment of a first psychotic episode~     with a schizophrenia spectrum diagnosis and who are eligible to undergo treatment with~     risperidone will be offered participation in the study. Clinical ratings, neuropsychological~     testing, neuroimaging and EEG will be conducted at baseline. Additionally, subjects will~     undergo the same assessments at week 12 to determine treatment-related biomarkers. Clinical~     ratings, including neurocognitive testing, will be conducted by blinded raters at study~     visits during treatment. Healthy controls (N=50) will also be recruited and scanned twice~     (12-week interval) to control for effects of time and practice.~   "
17975|NCT02822066|"~     The pupose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used~     preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests~     including the tumor markers to evaluate the general condition of patients. Intraoperative~     US/CEUS/CT would be applied to monitor ablation lesions.~   "
17976|NCT02822053|"~     The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US)~     -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the~     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and~     laboratory tests including the tumor markers to evaluate the general condition of patients.~     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.~   "
17977|NCT02822040|"~     This study will attempt to validate a method of estimating root length on panoramic~     radiograph by crown measurement on intraoral digital scans.~   "
17978|NCT02822027|"~     Infection and inflammation is related to increased encephalopathy of prematurities.~   "
17979|NCT02822014|"~     Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after~     two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB~     treatment response monitoring tool.~      Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of~     TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators~     correlated evolution of FDG uptake with clinical evolution of patients.~   "
17980|NCT02822001|"~     The Primary objective of this study is to determine whether patients who receive sugammadex~     immediately after tracheal extubation will exhibit a decrease in the incidence of~     postoperative residual paralysis and an associated decrease in the incidence of~     postoperative respiratory depression (which can precede critical respiratory events, CRE).~      The Secondary objectives are to: a) determine whether patients receiving sugammadex will~     have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and~     b) to improve patient safety by documenting whether postoperative respiratory depression~     (decreased MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor)~     is due to opioid administration vs. postoperative residual neuromuscular block (by comparing~     postoperative VAS scores and total opioid administered).~   "
17981|NCT02821988|"~     It is well established that obese women are at an increased risk of stillbirth compared to~     non obese women. This has led many physicians to begin antenatal testing in obese women in~     the third trimester through either nonstress tests or biophysical profiles. However, there~     is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of~     this study is to determine if antenatal testing improves outcomes in obese women and to~     determine the optimal mode of testing (either nonstress tests or biophysical profiles).~   "
17982|NCT02821975|"~     Cognitive impairment plays an important role in functional recovery and leads to long-term~     sickness absence. Therefore there is a need of a treatment specifically improving cognitive~     functions. In this pilot study the investigators aim to evaluate the feasibility of using~     cognitive computer training in patients with unipolar depression to enhance cognitive~     performance. Further the investigators investigate whether this intervention shortens sick~     leave.~   "
17983|NCT02821962|"~     Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates~     of total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been~     shown to be high in patients with cardiovascular disease, but it is not yet known if current~     CR programming results in significant reductions in these behaviours, or whether a targeted~     component is warranted. It is also unclear if self-reported sedentary time measures can~     provide valid and reliable information for monitoring these behaviours in a CR setting, or~     whether more objective measures are needed. The purpose of this study is to assess the~     feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR~     setting, describe changes in sedentary time that occur with standard CR and assess whether~     the addition of prompting cues from a device can result in further declines in sedentary~     behaviour and improvements in clinical outcomes, health related quality of life, symptoms of~     anxiety and depression, aortic stiffness, and aerobic capacity.~   "
17984|NCT02821949|"~     Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to~     check clinically, biologically and radiologically absence of infection. This biological~     evaluation is based on the CRP rate. Lots of infections may occur in this situation and~     could reduce by three the patient's life duration. However it is very important to make as~     early as possible a correct diagnosis of infection. CRP rate is classically higher for those~     patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is~     well-known for its better sensibility and specificity for the infection diagnosis but has~     never been study in case of active cancer. The aim of this study is to evaluate the~     Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and~     reliable method to use. So the investigators decided to include each new patient with NSCLC~     stage IV coming for his first-line chemotherapy without any infection sign, and to realize a~     Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the~     chemical laboratory and the result will not be communicated to the patient physician. A new~     clinical evaluation will be realized either at the hospital or by phone at day 7 to search~     any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21~     and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.~   "
17985|NCT02821936|"~     The purpose of this study is to evaluate the concordance between Positron E mission~     tomography parametric imaging versus standard PET for the 1 year prognosis of patients with~     NSCLC treated by radiochemotherapy.~      The ancillary study will evaluate the interest of parametric PET imaging during the~     treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a~     treatment re-planification or intensification (not realized on the present study).~   "
17986|NCT02821923|"~     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes~     in the food industry and are also recommended to diabetic patients. Both substances are~     already in use in the food industry and are freely available. Since the 1970s, beneficial~     effects on oral health could be demonstrated as oral bacteria were influenced positively. A~     pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit~     from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the~     blood vessels. In this trial, investigators aim to examine whether this effect can be found~     in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.~   "
17987|NCT02821910|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly~     developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin &~     metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and~     metformin XR administered simultaneously.~   "
17988|NCT02821897|"~     Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months~     Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus~     total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted~     with a multicolumn lead.~   "
18052|NCT02821039|"~     The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a~     collaborative project to coordinate a team of investigators from various regions of Turkey.~     The purpose of the Registry is to collect epidemiological data on patients with idiopathic~     pulmonary fibrosis and other causes of UIP, and to obtain information about the natural~     course of the disease and the treatment response.~   "
17989|NCT02821884|"~     Transcranial direct current stimulation (tDCS) has been shown not only to improve motor~     function but also increase cortical excitability and neural plasticity. Several studies~     demonstrated that the combination of tDCS and different treatments are more effective than a~     single tDCS alone. However, the effects of combination tDCS and neuromuscular electrical~     stimulation (NMES) on upper extremity motor recovery in patients with stroke have not yet~     been investigated. Taking into consideration the safety and feasibility of new medical~     technology, recruitment of healthy subjects as a pilot study. And then recruit the stroke~     patients to investigate the effects for the combination of tDCS and NMES on upper extremity~     motor recovery in stroke.~   "
17990|NCT02821871|"~     All eligible subjects were randomly assigned to group A and group B sequences, each sequence~     has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study~     ,the investigators collected the blood samples,urine samples and fecal samples to analyze.~   "
17991|NCT02821858|"~     The purpose of this study is to investigate the pharmacokinetics (PK), safety and~     tolerability following single oral administration of ascending doses of odalasvir (ODV) in~     healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability~     following single oral administration of ascending doses of AL-335 in healthy Japanese~     participants (Panel 2; Sequential Design).~   "
17992|NCT02821845|"~     This project will characterize lower extremity eccentric muscle function among individuals~     who have undergone locomotor training after spinal cord injury and will evaluate the effect~     of downhill training at slow speeds - targeted to rehabilitation eccentric function of the~     hip.~   "
17993|NCT02821832|"~     Background:~      Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts~     about 6 months. Some people with less severe TB might not need to take the drugs that long.~     Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might~     show who will be cured after only 4 months of treatment.~      Objective:~      To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for~     people with less severe TB.~      Eligibility:~      People 18 65 years old who have TB treatable with standard TB drugs~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      HIV test~      Sputum sample: Participants will be asked to cough sputum into a cup.~      Chest x-ray~      Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6~     more times during the 18-month study. Visits include:~      Sputum samples~      Physical exam~      Blood tests~      PET/CT scans at 2 3 visits: Participants fast for about 6 hours before the scan.~     Participants get FDG, a type of sugar that gives off a small amount of radiation, through an~     arm vein. They lie on a table in a machine that takes pictures of the body.~      Chest x-rays at 1 2 visits~      Participants who we believe are likely to be cured at 4 months will be randomly assigned to~     get either 6 months of treatment or 4 months of treatment.~      Participants may be asked to join a substudy using their sputum samples or additional blood~     tests.~   "
17994|NCT02821819|"~     The purpose of this prospective single-center study is to evaluate the laboratory outcome~     after random start ovarian stimulation in oocytes donors. The study will be performed in~     egg-donors but this type of treatment has the potential to be implemented in general~     infertility population.~   "
17995|NCT02821806|"~     Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the~     Expansion of T Cells for Adoptive Cell Therapy~      Background:~      New therapies are being developed that use a person s own immune system to fight tumors.~     Some of the tumors being studied include cancers caused by viruses. Researchers want to use~     the healthy cells of volunteers to perform research studies. To do this, they are collecting~     lymphocytes through leukapheresis.~      Objectives:~      To collect healthy cells from volunteers for research studies for new cancer therapies.~      Eligibility:~      Healthy people ages 18 and older~      Design:~      Participants will be screened with a standard donor questionnaire. It asks about their~     health and past medical problems. It also asks about risky behaviors that could increase~     their exposure to viruses or bacteria that could be transmitted through a transfusion.~     Participants will give a blood sample to make sure they are able to donate. They will have a~     physical exam. A finger stick test will check their hemoglobin, or red blood cell, level.~     They might give a urine sample.~      Participants will undergo apheresis. For this, a needle is placed in a vein in each of their~     arms. Their blood is taken from one arm. A machine separates the white cells from the red~     cells and plasma by a spinning process. The white cells are removed and directed into a~     plastic bag. The red cells and plasma are returned through the needle in the other arm. The~     entire procedure takes 4 6 hours.~      Participants may donate every 21 days in this protocol if they choose to.~   "
17996|NCT02821793|"~     The main objective of study is to describe the priorities of elderly patients (70 years and~     over) undergoing a first medical treatment for cancer, at initiation of treatment and after~     3 months of treatment. The main criterion is a prioritization of 4 items per patient from a~     list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life~     expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity,~     economics.~   "
18004|NCT02821689|"~     Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with~     prevalence up to 65%, and is considered to be one of the determining factors of prognosis.~     Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with~     characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies,~     mainly from Asia, including ours, have demonstrated that these patients with CADM tend to~     develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy,~     such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a~     6-month survival rate of less than 50%.~      Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of~     idiopathic pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients~     with IPF suggested that it could ameliorate pulmonary function decline and improve the~     progression-free survival. Its utility in connective tissue disease (CTD) related ILD has~     been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the~     investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone~     on RPILD associated with CADM.~   "
18093|NCT02820506|"~     The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in~     combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and~     in patients with cervical cancer tumour size > 2 cm.~   "
17997|NCT02821780|"~     Cerebral autosomal dominant arteriopathy with subcortical infarct (CADASIL) is a lethal~     disease caused by a gene mutation that affects arteries in the brain. Symptoms include~     migraines, strokes, memory loss, and dementia. There are no treatments. Researchers want to~     study people who have CADASIL to learn more about it.~      Objectives:~      To learn more about CADASIL by studying people who have it.~      Eligibility:~      People ages 18-100 who were diagnosed with CADASIL in the past 5 years and can make their~     own decisions~      Design:~      Participants will be screened in another NIH protocol.~      Participants will have 3 visits over 2 years. These may include:~        -  Physical exam~        -  Thinking and concentration tests~        -  Blood tests~        -  Skin biopsy: A small skin punch is removed from the arm or leg~        -  Eye exam and eye imaging tests~        -  Fluorescein angiogram: A catheter is placed in an arm vein. Dye is given through the~          catheter and travels~      to the eyes.~        -  EndoPAT: A small clamp on the fingertip measures blood volume.~        -  Cardio-ankle vascular index (CAVI): Artery stiffness is tested with blood pressure~          cuffs on the arms and~      legs. Soft electrodes on the skin measure heart signals.~        -  Brain MRI or MRA: They lie on a table that slides in and out of a tube that takes~          pictures. They may get~      a contrast agent in their vein. It brightens the brain so researchers can see where blood~     flows.~        -  CT scan of the heart: They lie on a table that slides in and out of a machine that~          takes pictures.~        -  They get contrast dye injected through a catheter. They may get a medicine that makes~          their blood~      vessels bigger or slows their heart rate.~   "
17998|NCT02821767|"~     Background:~      The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people~     with eye diseases.~      Objective:~      To examine and treat people with eye diseases and learn more about eye diseases and how they~     are inherited.~      Eligibility:~      People with eye diseases who can give consent or have a guardian who can consent for them~      Design:~      Participants will be screened with an eye exam.~      Participants will have 1 12 visits per year depending on their eye disease for up to 5~     years. Visits last about 4 hours and could include:~      Medical and family history~      Physical exam~      Eye exam and photography.~      Oculography: They put on contact lenses or goggles. They watch spots on a computer~      screen for 20 30 minutes.~      Electrooculography: Small metal disks are placed on the skin next to both eyes. They look~     left~      and right in the dark and light for about 30 minutes.~      Electroretinography: They sit in the dark with their eyes patched. A small metal disk is~     taped~      to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They~      watch flashing lights.~      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is~      injected through the tube and travels up the blood vessels in the eyes. Pictures are taken~     of the~      eyes.~      Immunosuppressive treatment~      Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small~      biopsy sample from the surface of the eye.~      Blood tests~      Skin, tear, urine, saliva, stool, or hair sample~      Exam under anesthesia for some children~      At each visit participants could get medications, eye drops, eye injections, laser~     treatments, or surgery.~   "
17999|NCT02821754|"~     BACKGROUND:~        -  Various tumor ablative procedures and techniques have been shown to result in~          immunogenic cell death and induction of a peripheral immune response. The term ablative~          therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency~          ablation (RFA) and cryoablation (CA).~        -  The underlying hypothesis of this study is that the effect of immune checkpoint~          inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular~          carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof~          of principle as well as safety and feasibility of this approach with anti-CTLA4~          therapy.~        -  Based on the concept of PDL1-mediated adaptive resistance and the emerging role of PD1~          therapy in HCC, we would like to evaluate the combination of tremelimumab and~          durvalumab (with ablative therapies) in HCC and BTC.~      Objectives:~      - To preliminarily evaluate the 6-month progression free survival (PFS) of combining~     tremelimumab and durvalumab in patients with advanced HCC (either alone or with~     cryoablation, TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC)~     (either alone or with cryoablation or RFA).~      ELIGIBILITY:~        -  Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma~          OR histopathological confirmation of carcinoma in the setting of clinical and~          radiological characteristics which, together with the pathology, are highly suggestive~          of a diagnosis of HCC (or biliary tract carcinoma).~        -  Childs-Pugh A/B7 cirrhosis only is allowed. If patient does not have cirrhosis, this~          limitation does not apply.~        -  Patients must have disease that is not amenable to potentially curative resection,~          radiofrequency ablation, or liver transplantation.~      DESIGN:~      We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in~     cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will~     receive tremelimumab and durvalumab only (i.e. No interventional radiologic procedures).~        -  A: Advanced HCC, BCLC# Stage B/C~             -  N= 1st 10 pts: No ablative procedure Cryoablation/RFA/TACE##~             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28~               days until EOS###~             -  40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem +~               dur + cryo~        -  B: Intra/extra-hepatic cholangiocarcinoma~             -  N= 1st 10 pts: No ablative procedure; RFA/ cryoablation~             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28~               days until EOS###~             -  30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem~                  -  BCLC = Barcelona clinic liver cancer staging system~                       -  For BCLC stage B patients TACE may be repeated as per standard of care~                            -  EOS = End of study treatment or meeting any of the off-treatment or~                              off study criteria.~   "
18000|NCT02821741|"~     Background:~      The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience~     of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to~     study how this stimulation affects the perception of pain. They also want to study how mood~     affects the experience of pain.~      Objective:~      To study the effects of mood and vagus nerve stimulation on the experience of pain.~      Eligibility:~      Healthy people ages 18 and older who are fluent in English~      Design:~      Participants will be pre-screened with a 15-minute phone call.~      Participants will have three 2-hour visits.~      At the screening visit, participants will be screened with:~      Medical and psychiatric history~      Physical and psychological exams~      Questionnaires about physical and psychiatric health and mood~      Urine tests~      A heat probe on the forearm. The temperature will be increased until it is painful~      but tolerable.~      Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do~     the following:~      Eat, use nicotine, or exercise for at least 2 hours~      Drink alcohol for 24 hours~      Take certain medicines for 3 days~      Testing includes:~      Urine drug screening~      Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an~     area~      of the ear away from the vagus nerve will be stimulated. This will be done with mild~     electric~      shocks that cause a tingling, pricking, or itchy feeling.~      Heat applied to the forearm until it is painful but tolerable~      Completing several forms on a computer or on paper about how they are feeling~      Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure~   "
18001|NCT02821728|"~     This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences~     in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made~     between participants randomised to the broccoli-rich diet and those randomised to the~     non-intervention arm.~   "
18005|NCT02821676|"~     Regional Anesthesia is a procedure in which numbing medication is injected around nerves~     that transmit pain from areas involved in a surgery. The objective is to block the nerves so~     a patient does not feel pain after surgery. Regional nerve blocks offer many advantages over~     traditional anesthetic techniques, including faster recovery time, fewer side effects and a~     dramatic reduction in post-surgical pain.~      The use of regional anesthesia in breast reconstructive surgery, such as the latissimus~     dorsi flap, has led to major improvements in patient care. Today, the most common regional~     anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block,~     where numbing medication is injected around the nerves supplying the chest wall.~      While intercostal nerve blocks have been used successfully in breast surgery, they do not~     provide a complete nerve block to the chest wall, as there are some nerves that are~     unaccounted for in the block which can contribute to a patients pain after surgery.~      The mixed pectoral one / serratus plane block (PECI/SPB) block is another regional nerve~     block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers~     a more complete pain blockade than the intercostal nerve block, as it includes more nerves~     that supply the breast. In addition to this, the intercostal nerve block is a so-called~     blind-technique compared to the PECI/SPB block, which is more accurately guided by~     ultrasound. Blind techniques are associated with higher failure rates.~      Both the intercostal nerve block and the PECI/SPB nerve block have been used successfully at~     the Ottawa Hospital. In this study, the investigators propose a prospective, double blinded,~     randomized controlled, head to head comparison of the PECI/SPB and intercostal nerve block~     to determine which block is associated with the best pain blockade and patient satisfaction~     in lattissimus dorsi flap surgery.~   "
18006|NCT02821663|"~     Systemic sclerosis is a systemic connective tissue disease with physical and mental~     disturbances. Based on a pilot study the feasibility and effectiveness of a novel,~     self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical~     guidance and music therapy is assessed.~   "
18007|NCT02821650|"~     The aim of this study is to find out the impact of a locally designed and manufactured~     improved stove intervention on the level of household air pollution and the impact on~     associated respiratory health indicators and predictors of women and children.~   "
18008|NCT02821637|"~     Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity~     and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to~     exercize because of their physical condition start an effort rehabilitation program at the~     Organization. The study will evaluate the impact of this rehabilitation program on quality~     of life and appetency to physical activity for these children and teens.~   "
18009|NCT02821624|"~     This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data~     for G1T38 in humans and will allow further development of G1T38 in patients with cancer.~   "
18010|NCT02821611|"~     The professional program in Physical Therapy is rigorous and demanding on students,~     resulting in high levels of fatigue, stress, and sleep disturbance that can impact student~     performance and wellbeing. This project seeks to investigate ways to reduce student stress,~     monitor their quality of sleep and possibly enhance their learning through the practice of~     meditation.~   "
18011|NCT02821598|"~     This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF)~     patterns delivered to the upper limb, lower limb and trunk for promoting motor irradiation~     to the contralateral lower limb.~   "
18012|NCT02821585|"~     Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic~     syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin~     resistance) that increase the cardiovascular risk. The investigators have observed in~     previous studies a strong association between the adherence to a Mediterranean diet and the~     prevalence of metabolic syndrome on patients with metabolic syndrome. However, no~     intervention has been realized on this population and the current recommendations (low fat~     diet) differ from the Mediterranean diet. A nutritional intervention on the principles of~     the Mediterranean diet could therefore play a role in the treatment of the metabolic~     syndrome in Type 1 diabetes patients. The main objective of this study is to examine the~     impact of a nutritional intervention on the waist circumference after 6 months of an~     intervention group (Mediterranean diet) versus a control group (low fat diet).~   "
18013|NCT02821572|"~     Autoimmune thrombocytopenia, also called immune thrombocytopenic purpura (ITP) is an~     autoimmune disease, characterized by the peripheral destruction of platelets of~     immunological origin and the inappropriate medullar production of platelets.~      Monocytes/macrophages play a double role by phagocyting platelets recognized by~     autoantibodies and by maintaining the autoimmune response via their function as antigen~     presenting cells. The functions of macrophages are partially regulated by binding with~     Immunoglobulin G at their receptors (FcγR) which could be inhibiting, FcγRIIb, or activating~     (FcγRI, FcγRIIa, FcγRIII). Therefore, a disequilibrium in the FcγRIIa/FcγRIIb ration could~     be implicated in ITP, as already reported for other autoimmune diseases like rheumatoid~     arthritis (RA) and systemic lupus erythematous (SLE) The aim of this project is to compare~     the expression of FcγR in patients with ITP who have been treated with rituximab with that~     in matched healthy subjects. A correlation between relative expression of these different~     FcγR (FcγRIIa/FcγRIIb ratio) and the response to splenectomy and to rituximab will be~     studied.~      This study is interventional because of a lots of blood sample The results of our study will~     in due course make it possible to define predictors of the response to treatments, so as to~     better identify patients likely to benefit from these different treatments.~   "
18014|NCT02821559|"~     Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil~     (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as~     well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is~     administered in 15-minutes infusion, complications related to continuous infusion can be~     avoided, and it becomes a potential good candidate for locoregional treatments as hepatic~     intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU,~     clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients,~     mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a~     synergic effect when combined with TS inhibitors, and its association with raltitrexed was~     evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one~     of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly~     FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a~     significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo.~     Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile~     even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and~     bevacizumab seems safe.~      Then, the investigators decided to perform a randomized pharmacokinetic comparative study~     between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX~     (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer~     patients, in a ping-pong crossover strategy to reduce the intra-individual variability.~     Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly~     schedules, respectively. The secondary end-points were, objective response rate evaluated by~     RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity~     between two arms for the first 2 cycles.~   "
18015|NCT02821546|"~     Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary~     research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography~     (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of~     peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP~     pancreatitis.~   "
18018|NCT02821507|"~     Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient~     survival. Current treatment options consist of wide surgical resection, however for patients~     with a local recurrence or metastatic disease the outcome is poor. New treatment options~     being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR)~     inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and~     thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in~     cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma~     treated with mTOR inhibitors have been conducted and they show promising results. From these~     studies the investigators can conclude that the combination of an mTOR inhibitor with~     cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment~     options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc~     consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according~     to a common protocol with the combination of sirolimus and cyclophosphamide using the growth~     modulation index for evaluation in the current clinical study protocol.~   "
18019|NCT02821494|"~     A phase I study to establish the highest safe dose that induces HPV16 E6-specific T-cell~     responses, using the highly promising novel therapeutic vaccine concept named: Hespecta (HPV~     E Six Peptide Conjugated To Amplivant®) to induce HPV16 E6-specific T-cell responses.~   "
18020|NCT02821481|"~     The purpose for this study is to determine if beta-alanine supplementation combined with~     endurance-based resistance training can increase gains in muscular endurance to a greater~     extent than endurance-based resistance-training alone in older adults.~   "
18021|NCT02821468|"~     A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of~     DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES~     study was a phase IV, double blind, randomized and non-inferiority trial to compare the~     efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) +~     chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA~     with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain~     subscale by 50% without significant difference between groups. Further, there was no~     difference in all secondary outcomes assessing patient's pain, functional capacity,~     stiffness, inflammation, joint swelling, effusion, and overall quality of life.~      This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the~     good health of the cartilage of patients suffering of knee osteoarthritis as revealed by~     qualitative assessment of cartilage biochemical composition in vivo.~   "
18022|NCT02821455|"~     The aims of the study is to determine if end-tidal concentrations of the anaesthetic gases~     isoflurane and sevoflurane as measured by a standard gas monitor are related to the blood~     levels during one-lung ventilation.~   "
18023|NCT02821442|"~     To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent~     painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel~     chemotherapy 6 months prior~   "
18024|NCT02821429|"~     Respiratory weaning failure worsens prognostic of patients following on-pump cardiac~     surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic~     echographies are useful in order to improve this critical medical status.~      Based both on a previous study conducted in the critical care unit of Purpan and on~     literature we hypothesize that a combined thoracic echography score could be of interest. We~     make the hypothesis that the use of a score based on thoracic combined echography (ETC =~     cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning~     in cardiac surgery and allows to improve the characterization of the causes of this failure~   "
18025|NCT02821416|"~     This is a randomized, double-blind, parallel group, placebo-controlled study designed to~     evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every~     4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with~     an inhaled allergen.~   "
18026|NCT02821403|"~     Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity,~     accommodative response, color vision, and subjective grading of the quality of life and~     vision.~      Purpose: To determine and compare the visual performances after wearing the blue-light~     blocking lenses in participants with and without presbyopia.~      Methods: One hundred and sixty computer users (computer usage >2 hours/day) with (n=120,~     aged >40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three~     pairs of ophthalmic lenses will be prescribed for the participants, in which one pair of~     them will be the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be~     used for intermediate vision (i.e., computer usage) in presbyopic group, and for distant~     vision in non-presbyopic group. The adaptation period for each pair of lenses will be 1~     month. The pre- and post-treatment contrast sensitivity, accommodative response and color~     vision will be measured. The participants will also be asked to complete questionnaires~     about their quality of life and vision, and the performances of these ophthalmic lenses.~      Significance: The blue-light blocking lens reflects the short-wavelength lights and protects~     the retina from blue-light hazards; however, blue lights are eccential for various visual~     function and circadian rhythms. This study will evaluate the impact of the blue-light~     blocking lenses on visual function and quality of life, and determine whether the blue-light~     blocking lenses are good choices for extra ocular protection.~   "
18027|NCT02821390|"~     The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to~     intravitreal injections will be evaluated.~      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.~   "
18028|NCT02821377|"~     Introduction: Patients with chronic liver diseases are usually thin as a result of~     hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of~     other adyponectins such as visfatin.~      Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide~     plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard~     oral diuretic schedule, in patients with cirrhosis and refractory ascites.~      Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to~     outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment~     with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the~     first day after admission until 3 days before discharge (Group A ), or repeated paracentesis~     from the first day after admission until 3 days before discharge (Group B, ).~      Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and~     after the two type of treatment.~   "
18032|NCT02821325|"~     The purpose of the study: is to quantify the amount of post-operative effusion or hematoma~     present after total knee arthroplasty pre-operatively, post-operative day #0,1.~      Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at~     the following times:~        -  Pre-operatively~        -  Post-operative day #1 (approximately 16-20 hours post op)~        -  Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the~          Loma Linda radiology department as per normal protocols. No special imaging procedures~          will be undertaken.~      Subjects will be both male and females, they will be patients from the Principle~     Investigator and Co-Investigators practice. Subjects will be between the ages of 18-89 years~     of age.~      The total participation will last approximately 30 days.~      Subject selection will be approximately 10 English speaking, both male and female between~     the ages of 18 to 89 years of age. Subjects will be recruited from the Principal~     Investigators and Co-Investigators clinic. There will be no advertising or electronic~     recruiting. The study is expected to last 12 months.~   "
18033|NCT02821312|"~     This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study~     to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral~     Administration of DA-8010 in Healthy Subjects.~   "
18034|NCT02821299|"~     The experience of face and hand composite tissue transplantations reported in the~     international community have mainly concerned trauma patients. Feasibility and individual~     benefit have been demonstrated for these indications, in properly selected patients. The~     first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A~     certain number of patients, who have suffered direct (extended period of intubation during a~     stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns)~     to the larynx, present irreversible trauma or injury to the larynx in which conventional~     treatments are unable to restore laryngeal function. These patients find themselves severely~     disabled, with a significant reduction in their quality of life. They suffer from~     stigmatization which leads to social isolation (professional and personal). In some~     circumstances, providing healthy tissue and anatomical or functional components (cartilage,~     muscle, nerves, blood vessels) by means of an allogeneic laryngeal transplantation, is the~     only way of allowing patients, whose quality of life has been seriously affected, to speak,~     breath and swallow normally. The extremely promising results from other international teams~     in this area have encouraged the investigators to present this project.~      The specificities of the protocol compared to previous transplantations carried out by other~     teams are:~        -  The technique for nerve re-innervation which should make it possible to decannulate all~          patients and improve functional outcomes in the graft.~        -  A dual therapy immunosuppressive regimen will be used, if the patient's clinical and~          biological status permits, which can be adjusted according to the type of tissue~          grafted.~      It might be thought that the need for immunosuppressive therapy means the indications will~     remain rare, representing an incidence of less than five patients a year in France. However,~     the interest of this research project does not reside in the number of patients concerned~     but rather the total lack of any existing therapeutic solution. Conducting a case series~     will help determine whether, under certain conditions, laryngeal transplantation can improve~     the management of patients for whom the usual reconstructive surgery options are~     unsatisfactory.~      The study is intended to provide a descriptive analysis of a case series of three laryngeal~     transplantations before and after comparisons, each patient serving as their own control.~   "
18035|NCT02821286|"~     This project intends the analysis and profiling of specific antibodies against major peanut~     allergens in peanut allergic individuals and molecular cloning of human antibodies against~     major peanut allergens.~   "
18036|NCT02821273|"~     In preterm infants with respiratory distress syndrome, mechanical ventilation is related to~     increased risk of death and complications. Surfactant is an important methods to reduce~     mortality and intubation rates. INSURE technique is a standard method to administrate~     surfactant. However, several preterm infants need two or more surfactant, and therefore one~     more intubation is needed. How to reduce the times of intubation is an challenges for~     neonatologists.~   "
18037|NCT02821260|"~     The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader~     center for surgery of epilepsy in infants and children.~      Postoperative follow-up of these children is performed during medical and neurosurgical~     consultations in order to assess the frequency of attacks and to reduce medication.~      On average, two postoperative consultations are carried out between 3 and 5 months and~     between 12 and 18 months. Beyond 18 months, some children may benefit from long-term~     monitoring at this center, but most children are followed by their neurologist .~      Therefore, the center has no rigorous and systematic collection of standardized data on the~     outcome of these patients.~      The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children~     with a monitoring of 3 years.~   "
18038|NCT02821247|"~     This is a prospective, observational, multi-center, study. The study will be conducted in~     approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to~     collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120~     patients for which the decision to treat with intravitreal aflibercept injections is made at~     the discretion of the attending physician, according to his/her medical practice. Visits~     will be performed at baseline, aflibercept first injection (if different from enrollment)~     and at 12 and 24 months. The 12 and 24 month comprise the data collection visits during~     which any data generated in the period preceding these visits will be recorded.~      All required information for the purposes of this study will be collected using electronic~     Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be~     specifically designed for the needs of the study and will adhere to all applicable data~     protection regulations and requirements with regard to electronic records.~      The study observation period for each patient enrolled in this study is the time from the~     beginning of treatment with intravitreal aflibercept injection up to two years or until~     discontinuation of intravitreal aflibercept injection-treatment due to any reason including~     withdrawal of consent or patient loss from follow-up.~   "
18063|NCT02820896|"~     This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the~     safety, tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two~     participant populations: healthy participants and participants with mild-to-moderate~     Alzheimer's disease. This study is a single dose, dose-escalation, and multiple dose study~     comprising approximately six single dose cohorts in healthy participants administered~     RO7105705, either intravenously (IV) or subcutaneously (SC), and comprising one or more~     multiple dose cohorts in healthy participants administered RO7105705 IV every week (QW), a~     total of 4 doses, and one or more multiple dose cohorts in participants with Alzheimer's~     disease administered RO7105705 IV QW, a total of 4 doses.~   "
18064|NCT02820883|"~     This is an open-label, dose-escalation pilot study with a total of 30 participants with 10~     per dosage group. The aim of the pilot study is to explore the preliminary safety of an~     experimental recombinant staphylococcus aureus vaccine.~   "
18039|NCT02821234|"~     One-tenth of the population suffers from insomnia, increasing their risk on other health~     problems such as depression. Self-reported sleep quality only was historically leading for~     insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated~     with insomnia, either physiological (increased heart rate, higher frequency EEG) or~     predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts).~     Strong evidence shows that those suffering from insomnia with physiological hyperarousal are~     at higher risk of short and long term severe health problems such as inflammation and~     hypertension than the group without physiological hyperarousal. The neurophysiological basis~     of these insomnia phenotypes has however barely been investigated, although its results can~     have major consequences for how this limiting condition will be treated.~      To support the development of a differential diagnosis of insomnia, structural and~     functional brain connectivity in insomnia patients with different levels of hyperarousal~     will be investigated and related to sleep variables. Investigators will compare the insomnia~     group to a normal sleeping control group. Investigators expect that the emotion processing~     circuit (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared~     to normal sleeping controls and b) the directionality of this effect to depend on the level~     and type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity~     to be positive correlated with physiological hyperarousal level and d) prefrontal activity~     to be positively correlated with cognitive-emotional hyperarousal level. Investigators~     expect a higher physiological hyperarousal level to be reflected in affected afferent~     pathways of the amygdala towards the ventromedial prefrontal cortex and investigators expect~     higher cognitive-emotional hyperarousal to be related to affected efferent pathways from the~     ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a~     mediating role in both types of hyperarousal and their brain activation patterns in insomnia~     patients and normal sleeping controls.~      These data can lead to the definition of new insomnia phenotypes and to new customized and~     effective insomnia treatment, focused not only on improving sleep but also on changing~     dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe~     health problems.~   "
18040|NCT02821208|"~     The goal of this study is to identify the prognostic factors of quality of life in patients~     with psychogenic non-epileptic seizures~   "
18041|NCT02821182|"~     We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved~     clinical response rates and PFS compared to anti-PD1 treatment in monotherapy.~      The current phase II trial aims at exploring the suggested benefits of the combination and~     aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects~     of radiotherapy in addition to anti-PD1 treatment.~   "
18042|NCT02821169|"~     Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many~     chronic rhinosinusitis for whom the medical treatment failed. In order to improve the~     postoperative management of patients treated with ESS, we aim to assess the analgesic action~     of local injection of ropivacaine in the nasal fossa.~   "
18043|NCT02821156|"~     This is a prospective, observational, multicenter study conducted during 1 year in adult and~     paediatric intensive care units equipped with the EZ-KINOX™ system.~      A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial~     Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in~     the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™~     system was planned to be included.~      The study is strictly non-interventional with the aim of describing current practices and~     therefore did not affect the patient usual management.~   "
18044|NCT02821143|"~     Investigators hypothesize that telemedicine may be an effective tool to improve palliative~     care in nursing home, by providing on-site specialized and interprofessional consultation.~     The objective of this study is to assess the impact of telemedicine in decreasing the rate~     of hospitalization, compared with usual care, in nursing home resident with palliative care~     needs.~   "
18045|NCT02821130|"~     Shortness of breath (dyspnea) during exercise is a major source of distress and is a~     commonly reported symptom in patients with cystic fibrosis (CF). A recent treatment option~     known as Orkambi, which combines the drugs lumacaftor and ivacaftor, may be used in patients~     with CF to help improve lung health. However, the effects of this combination therapy on~     dyspnea and exercise performance, a known predictor of survival in CF, are not clear. The~     investigators aim to understand the effects of Orkambi on these symptoms and to gain new~     insight into the potential health improvements in CF from using this treatment option.~   "
18046|NCT02821117|"~     The study is designed to determine glycaemic control achieved using the FreeStyle Libre~     Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose~     (SMBG) for the self-management of diabetes.~   "
18047|NCT02821104|"~     This study evaluates how genetic variations in complement, a part of the immune system,~     affect cardiovascular risk in adolescents.~   "
18048|NCT02821091|"~     Aim 1: Determine the relationships between muscle quality and balance performance as well as~     any association with fracture and fall history in older adults.~      Muscle quality will be calculated from the information of muscle strength and body~     composition (strength/lean muscle mass). The investigators will compute the joint torque~     during functional activates using biomechanical data from the 3-D motion analysis, whereas~     the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis~     (BIA). Clinical and functional assessments for balance performance will also be conducted.~     Fracture and fall history prior to the testing will be recorded retrospectively.~      Aim 2: Identify the relationships between force usages during balance perturbation in older~     adults.~      Lateral and forward/backward perturbation while walking will be used to elicit balance~     recovery responses. The degree of necessary joint force and how this relates to a person's~     functional capacity at specific joint levels will be determined by the torque demand to~     capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a~     joint-specific unified scalar quantity representing the balance recovery demand normalized~     by the maximum muscle strength capacity of an individual. It would indicate whether a person~     can recover balance and to what extent of his/her maximum capacity is taxed.~      Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized~     strengthening and balance training program on improving balance performance in older adults.~      Personalized strengthening and balance training exercise will be personalized based on the~     results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and~     split-belt balance perturbation instrumented treadmill. The exercise group will receive~     training 2 times a week for 2 months and the age-matched control group will maintain their~     usual daily life activities. All assessments will be performed at baseline, and 1 week after~     training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following~     the training period.~   "
18049|NCT02821078|"~     The objective of the project is to establish the 3D velocity mapping of the hepatic~     vasculature and its consistency. Specifically, the investigators will assess the consistency~     of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein)~     and outflow (inferior vena cava differential flow). According to the mass conservation~     physical property, blood inflow must equals blood outflow. The relative gap between the~     measured values will characterize the consistency of the acquisition.~   "
18050|NCT02821065|"~     Modern technology like computers, smartphones and the Internet enable patients to measure~     certain health indicators, like blood pressure and body weight, from the comfort of their~     own homes. This information can also be shared electronically with doctors and other~     healthcare providers to monitor remotely. This is called home health monitoring. In~     TEC4Home, we are developing a home monitoring solution for patients with heart failure to~     support their care and recovery at home after a visit to the emergency department. We hope~     to show that this solution decreases revisits to the emergency department and increases~     quality of life for patients.~   "
19448|NCT02802683|"~     The purpose of this study is to compare the frequency of hypotension between hyperbaric~     anesthetics and isobaric anesthetics during cesarean section and determine whether~     continuous infusion of phenylephrine is effective in mothers who received hyperbaric~     anesthetics.~   "
18053|NCT02821026|"~     Islet transplantation is a relatively new procedure used in people with difficult to control~     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas of a deceased~     organ donor. After the cells are carefully prepared, the islets are transplanted into~     patient's body. These transplanted islets may produce insulin for the patient. Patient may~     be able to reduce or eliminate the need for insulin injections for an unknown period of~     time. Patients who receive an islet transplant may need to stay on powerful~     immunosuppressive drugs for as long as the islets remain alive and working. These drugs help~     to prevent the immune system from attacking the transplanted islets.~      Under current standard of care procedure, islets are transplanted into patient's liver. The~     investigators have learned that some of these cells do not survive the current procedure and~     are lost around the time of transplant. Therefore in this study, the investigators are~     studying a new transplant procedure that may help prevent this islet cell loss. The new~     procedure involves transplanting the islets into an omental pouch instead of into the liver.~     The omentum is a large apron-like fold of membrane inside the abdomen that drapes over the~     intestines. This study will test to see if omental islet transplantation is safe and~     effective. Standard immunosuppressive medicines (anti-thymocyte globulin, tacrolimus,~     mycophenolic acid, sirolimus, etanercept) will be used in this study to prevent rejection of~     the islets.~      This study is a collaborative research with the University of Miami, and the same study~     protocol has been in use over there. Recruitment in Edmonton will continue until all~     subjects [N=6] needed for the study are transplanted. All subjects in this study will~     receive islet transplants using the study procedure.~   "
18054|NCT02821013|"~     The purpose of this study is to compare the effects on melanoma of taking a government~     approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent~     continuously. Researchers want to see if the two ways of giving this type of treatment work~     equally well in extending the life of patients with melanoma, or not.~   "
18055|NCT02821000|"~     The purpose of this study is to determine the safety, tolerability, and overall response~     rate (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or~     metastatic melanoma, with disease progression following first line chemotherapy or targeted~     therapy. ORR will be based on Response Evaluation Criteria in Solid Tumors version 1.1~     (RECIST 1.1). The primary hypothesis is that ORR per RECIST 1.1 by central independent~     radiology review is greater than ORR from historical control (10%).~   "
18056|NCT02820987|"~     This study evaluates PK/PD of an extended-infusion protocol of meropenem,~     piperacillin-tazobactam and cefepime, in the early phase of septic shock.~   "
18057|NCT02820974|"~     There lacks effective early screen system for the migraine-susceptible women during the~     peri-menopause period. The processing of acute pain and cognition as well as the underling~     functional magnetic resonance imaging (fMRI) features are suitable for screening~     pain-susceptible individual. However, there is no study on this issue among the large sample~     peri-menopause women. The investigators thus designed the current trial to investigate the~     processing of acute pain and cognition as well as the underling featured functional magnetic~     resonance imaging (fMRI).The investigators will combine pain behavior,cognitive task, fMRI~     analysis, psychophysiological interaction (PPI) and suitable statistical package to~     investigate the relationship between the above mentioned features and the occurrence of~     migraine and then test the efficacy of these features in predicting migraine development.~     The investigators will then try to establish the screening system for migraine-susceptible~     individuals in peri-menopause women.~   "
18058|NCT02820961|"~     The purpose of this study is to determine the effect of exemestane on the pharmacokinetics~     (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in~     patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast~     cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in~     combination with exemestane, and assess the effectiveness of entinostat in combination with~     exemestane in terms of best overall response and overall survival.~   "
18059|NCT02820948|"~     A prospective, randomized study was performed. The patients were randomized into 2 groups:~     those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those~     patients who not (Group 2).~      Incisional surgical site infection (SSI), microbiological cultures from the infected~     surgical wounds, postoperative pain and acute phase reactants were investigated.~   "
18060|NCT02820935|"~     This is a two-part study to be conducted at a single study site in the US. Both parts of the~     study may be conducted in parallel.~      A total of approximately 38 subjects will participate in this study, with approximately 19~     subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only~     participate in one of the parts.~   "
18061|NCT02820922|"~     The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in~     our clinic for emergency orthopedic surgery at a 1 year period.~   "
18062|NCT02820909|"~     The femoral approach is the preferred vascular access for the set-up of emergency catheters~     in severely traumatized patient. This location combines simplicity and speed of~     installation, it allows the simultaneous set-up of arterial and venous catheters, and is a~     provider of few complications and failures.~      The ultrasound guidance has greatly reduced installation times, failures and complications~     related to the set-up of central venous catheter. This was amply demonstrated in the~     internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al~     2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for~     the set-up of arterial and venous catheters in the femoral emergency has not been evaluated~     in terms of reduction in complications.~      Then the main objective of this study is to demonstrate that the ultrasound guidance reduces~     early complications related to the set-up of arterial and venous catheters in the femoral~     emergency, among severely traumatized patient compared to the reference anatomical~     technique.~   "
18065|NCT02820870|"~     The investigators are trying to understand the impact of the new VA/DoD cholesterol~     guidelines on primary care clinics and what the VA or the clinic could do to help clinicians~     and teamlets improve their statin use. To do this, the investigators will talk to providers~     about these guidelines and perform a brief intervention to help providers meet the~     guidelines' recommendations.~   "
19724|NCT02799030|"~     This was a placebo controlled, double blind, randomized phase II dose-response study to~     evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 -~     aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic~     keratosis (AK).~   "
18066|NCT02820857|"~     Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive~     neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and~     digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.~      Recent data on the initial presentation of GEP-NEC have been reported in two retrospective~     studies and a French cohort study. No standard second-line treatment has been defined for~     NECs. Despite a very negative prognosis, these NECs have a certain amount of~     chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri,~     or Folfox, or single drug treatments such as temozolomide are the proposed options but with~     a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown~     promising results in well differentiated neuroendocrine tumors (NET), known for being~     hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but~     never in the context of a phase II study. Its combination with Folfiri is efficient and well~     tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially~     represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or~     III studies have reported results for these patients, and no on-going phase II or III trial~     have been identified to date.~      The main objective of this study is to show that, after the failure of a first-line~     chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows~     significant prolongation of overall survival in adult patients with GEP-NEC.~   "
18067|NCT02820844|"~     GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of~     overactive bladder (OAB) in several countries, however, it has not been approved for OAB~     treatment in Japan. This study has been planned to evaluate the efficacy and safety of~     GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been~     adequately managed with other medications for OAB.~      The primary objective of this study is to evaluate the superiority of a single dose~     treatment of GSK1358820 100 units (U) compared with placebo.~      The study comprises a screening phase up to 28 days, followed by a double-blind treatment~     phase of 12 to 48 weeks wherein subjects will receive a single treatment of either~     GSK1358820 100 U injection or Placebo injection, in a ratio of 1:1, with further~     stratification within the treatment arms according to the number of urinary urge~     incontinence episodes during screening. Subjects meeting the criteria for re-treatment will~     receive a second and third treatment. Each re-treatment will be with open-label GSK1358820~     100 U injection, and will be spaced at least 12 weeks from the previous treatment.~      The total duration of participation for any subject will not exceed 52 weeks, including~     screening and the 48-week treatment period.~   "
18068|NCT02820831|"~     A prospective observational cohort study to assess the predictive value of preoperative~     frailty on postoperative quality of life in peripheral vascular surgery patients.~   "
18069|NCT02820818|"~     Preterm birth alters the normal sequence of lung development with lasting respiratory~     consequences. It is still unclear whether observed respiratory morbidities in preterm born~     individuals reflect sequelae from a non-progressive lung disease that occurred early in life~     or result from ongoing active disease that, if left undiagnosed and untreated, could~     increase the risk of a COPD-like phenotype. We propose to examine micro-structural~     abnormalities of the lung using innovative non-invasive imaging technologies in relation to~     pulmonary function and markers of inflammation and oxidative stress in young adults born~     preterm.~   "
18070|NCT02820805|"~     The purpose of this study is to determine the effect of carbohydrates on blood glucose~     levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight~     (NW) and overweight or obese (OW/OB) children.~   "
18071|NCT02820792|"~     The LMA ProtectorTM is a new extraglottic airway device which brings together features of~     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate~     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM~     (single use - prevention of disease transmission). In the following randomized study the~     investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,~     fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM~     and the Ambu AuraGainTM in paralyzed, anesthetized patients.~   "
18072|NCT02820779|"~     The purpose of this study is to evaluate the effectiveness, long-term safety and explore the~     safety and efficacy factors WILLIS™ intracranial stent graft system in clinical~     applications.~   "
18073|NCT02820766|"~     The primary objective of the study is to determine how the short-term outcome of subjects~     implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with~     other PS total knee systems, and to determine if there is a difference in health care~     resources consumed that may result in economic savings to patients, the facility and/or the~     payer.~      To address the study objectives, patient self-assessment questionnaires, and other objective~     measures of post-operative function and health care resource utilization will be used for~     data collection.~   "
18074|NCT02820753|"~     This study will leverage available technologies and test strategies to impart the Universal~     Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely~     use, and adhere to their complex medication regimens.~   "
18075|NCT02820740|"~     Multicenter, open-label, prospective designed study to characterize the performance of brain~     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for~     the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are~     candidates for LITT surgery.~   "
18076|NCT02820727|"~     This study addresses the influence of anesthesia induction, ventilation and influence of~     cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function.~     Influence on patient outcome is also studied. Three dimensional echocardiography is applied.~   "
18077|NCT02820714|"~     The objective of this study is to evaluate BLI801 laxative in adults experiencing~     non-idiopathic constipation.~   "
18078|NCT02820701|"~     This prospective, randomized, controlled trial is proposed to investigate the effect of OMT~     on sacral base asymmetry as assessed by ultrasound.~   "
18079|NCT02820688|"~     This prospective, randomized, double blind study aims to determine the optimal volume for~     adequate sensorial and motor blockade following an infraclavicular block. Patients will be~     randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine~     180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL,~     second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor~     block will be compared for patients between groups~   "
18080|NCT02820675|"~     The German Quality Network Sepsis is an association trying to improve quality of care for~     patients with sepsis, severe sepsis and septic shock or being in risc thereof.~      The icosmos trial investigates the impact on the use of routine data, a risk adjustment~     algorithm and feedback to all hospitals as well as a structured implementation for regular~     screening for deteriorating patients, and education on in-hospital mortality.~   "
18081|NCT02820662|"~     The development of the retinal vascular network is generally complete during the 3rd~     trimester of pregnancy but may continue during the first 15 days of life. This late~     maturation may cause problems in pre-term births and may result in immature vascularization~     of the retina, a condition called retinopathy of prematurity. Among the different factors~     affecting the development of the retinal vasculature, the tissue level of omega-3~     polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the~     PUFA present in the tissues (nature of the phospholipids in their membranes). This project~     aims to show a possible association between levels of omega-3 PUFA and the onset of~     retinopathy of prematurity (ROP).~   "
18082|NCT02820649|"~     Rationale. Sleep loss is a risk factor for cardiovascular events mediated through~     endothelial dysfunction.~      Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction~     induced by total sleep deprivation (TSD) in healthy young men.~      Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of~     interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well~     as pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at~     baseline, during TSD, and after one night of sleep recovery. Biomarkers of endothelial~     activation, inflammation, and hormones will bemeasured from morning blood samples at 07:00~   "
18083|NCT02820636|"~     The study is about developing the best aftercare treatment possible for Latino/a adolescents~     who have been hospitalized in a psychiatric unit due to a suicidal crisis (suicidal thoughts~     or attempts). The treatment's purpose is to help adolescents and their caregivers develop~     skills to prevent future suicidal crises. Latino/a adolescents usually report more suicidal~     behavior than other ethnic groups. The question that the investigators want to answer is if~     a new treatment (socio-cognitive behavioral therapy-(SCBT)) developed to their specific~     needs, taking into account their culture and aspects of adolescence, performs better than~     the treatment that they usually receive. Fifty adolescents will be recruited from the~     Bradley Hospital adolescent inpatient unit or the Hasbro Inpatient Medical & Psychiatric~     Program, or referred to Gateway Healthcare after discharge from other inpatient units in~     Rhode Island; half of them will be assigned randomly to the treatment they would usually~     receive (TAU) and the other half to the new treatment (SCBT). In both groups, caregivers and~     adolescents will have to complete questionnaires and interviews before the beginning of~     treatment and at 3, 6, and 12 months after the treatment begin. Questions to the~     participants will be related to their presenting symptoms, family, social group, problems,~     and other similar topics. Also, participants will be asked about their satisfaction with the~     treatment they are receiving. The purpose of the questionnaires and interviews are to follow~     their progress in therapy. At the end, comparisons will be made between the group who~     participated in TAU and the group who participated in the SCBT, based on the assessment~     results from the adolescents and caregivers.~   "
18084|NCT02820623|"~     The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity~     measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The~     investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3~     conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each~     group). To calculate the outcomes of interest, each condition will be compared to the~     gold-standard fidelity measurement method, direct observation.~   "
18085|NCT02820610|"~     It is important to keep children undergoing laparoscopic surgery pain free.~   "
18086|NCT02820597|"~     This pilot study is a single arm study designed to evaluate the feasibility of cryoablation~     in the nasal passageway using the ClariFix Device, to reduce the symptoms of chronic~     rhinitis.~   "
18087|NCT02820584|"~     Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20~     patients (in order to achieve 12 valuable patients). The expected accrual time would range~     between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring~     will end two years after the initial surgery of the last patient enrolled. The primary~     objective will be to assess the activity of immunotherapy in terms of its effect on immune~     response. In particular we will investigate the effect of treatment on effector cells~     including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12~     eligible patients was identified on ethical and practical considerations, rather than by a~     formal sample size calculation.~   "
18088|NCT02820571|"~     The OPAL study is about health outcomes in older adults. The investigators are surveying~     4,000 adults across England to see how health and physical activity change over time. The~     information that is collected will help the investigators to understand how a person's~     health, including conditions such as back pain, affect their mobility as they age, and~     provide insight into improving the management of health in older adults.~   "
18089|NCT02820558|"~     This study evaluates the delivery of substance P via the celiac artery in the treatment of~     recent onset type 1 diabetes.~   "
18090|NCT02820545|"~     The study aims to construct and validate a self-administrated questionnaire to assess the~     patients' perception of patient safety in surgical care units. The originality of the study~     is to perform sociological interviews of hospitalized patients to assess their own~     perception on the safety of their care and to create corresponding items which will be~     included in a new questionnaire. In a second step, patients' perception of patient safety~     will be assessed in numerous surgical care units in France, in order to analyze the~     psychometric properties of the questionnaire and consequently to validate the questionnaire.~     The patients' perception will be compared to the healthcare professionals' perception on~     patient safety and to the patient safety strategies in place in the care units.~   "
18091|NCT02820532|"~     Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate~     for this uncertainty. However it is not known if the couch motion influences the respiratory~     pattern of the patients. This will be evaluated in this study on healthy volunteers.~   "
18094|NCT02820493|"~     Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and~     Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical~     practice for the treatment of patients with Crohn disease (CD). Unfortunately, their~     efficacy is limited. Based on these concepts, a new drug has been developed for IBD~     treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively~     blocks gut lymphocyte trafficking.~      The hypothesis of this study is that VDZ therapy may be to halt CD disease progression~     during time and modifying its natural history, using Lemann Index.~   "
18095|NCT02820480|"~     Rehab in a Crate is a therapy gym designed to be affordable, compact and easily~     transportable. The purpose of this particular study is to gain feedback on the initial~     design of the Rehab in a Crate system. This will be accomplished by using qualitative~     ethnographic research methods (i.e. human centered design) in the form of surveys that have~     been carefully designed by members of the research team. The eligibility criteria of this~     survey research reflects the intended user base of an eventual finished product, which is~     survivors of stroke and cerebral palsy across the globe. And while healthcare professionals~     are not the user base per se, their expertise and feedback should be instrumental in the~     design of future iterations of the Rehab in a Crate. Ease of use, utility, design, and~     various features, both existing and intended, will all be surveyed items.~   "
18096|NCT02820467|"~     Investigators conduct a monocentric pilot study with the objective to determine the~     hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best~     correlated with toe pressure in patients with suspicion of critical limb ischemia.~   "
18097|NCT02820454|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. AGuIX particles~     may increase the effectiveness of radiation therapy by making tumor cells more sensitive to~     radiation.~      PURPOSE: This first-in-man Phase I trial will study the side effects and best dose of AGuIX~     when injected together with whole brain radiation therapy in treating patients with multiple~     brain metastases. The effectiveness of the combination of AGuIX and radiation therapy will~     be also assessed.~   "
18098|NCT02820441|"~     The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with~     14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.~   "
18099|NCT02820428|"~     Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in~     Parkinson's disease. They may be induced by both the pathology and the dopaminergic~     treatment and must be considered in treatment policies.~      Due to their specificity and the absence of an appropriate evaluation tool, behavioral~     disorders are rarely searched for.~      Therefore, investigators developed a scale permitting qualitative and quantitative~     evaluation of behavior according to the severity of the disorders.~      This study aims to define reference values for healthy individuals~   "
18100|NCT02820415|"~     Oocyte accumulation by vitrification is a valid strategy to increase the number of available~     embryos for biopsy and the number of viable euploid embryos to transfer after~     preimplantation genetic testing.~   "
18101|NCT02820402|"~     Project Viva is a prospective cohort study of maternal and child health, following over~     2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.~   "
18102|NCT02820389|"~     This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for~     patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS~     costs and waiting times whilst increasing patient satisfaction compared to clinical practice~     with utilisation of Optical Colonoscopy.~   "
18103|NCT02820376|"~     The purpose of this study is to assess the degree of agreement of the measurement of~     differential renal function in living donors by CT (computed tomography) and SPECT (single~     photon emission computed tomography).~   "
18104|NCT02820363|"~     The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used~     in conjunction with standard-of-care treatment compared to standard-of-care treatment alone~     in the care of subjects with open fractures of the tibial diaphysis.~   "
18105|NCT02820350|"~     The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to~     renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute~     kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)~   "
18106|NCT02820337|"~     The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose~     tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV~     infection, anf morbid obesity with undetectable viral load (VL) and having HIV~     lipohypertrophy particularly truncal. The study covers both the morphology of~     adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of~     antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue~     and the plasma before and after bariatric surgery.~   "
18107|NCT02820324|"~     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine~     administered as needed (PRN) compared with placebo in patients with moderate to severe acute~     pain after abdominoplasty.~   "
18108|NCT02820311|"~     The purpose of this study is to evaluate if TD-4208, an investigational drug being developed~     to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the~     electrical activity of the heart.~   "
18109|NCT02820298|"~     The purpose of this study is to investigate the effect of a high-fat meal on the levels of~     bexagliflozin in the blood in healthy subjects.~   "
18154|NCT02819713|"~     This is a randomized controlled trial. One group (intervention group) will get in advance to~     the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group)~     will get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured~     using the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0~     is no pain and 10 is most worst imaginable pain.~   "
18175|NCT02819440|"~     Obesity and its adverse cardiometabolic consequences are major public health problems.~     Several features of obesity contribute to the associated cardiovascular risk and are~     potential targets for intervention. These include insulin resistance and beta cell~     dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study~     is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic~     health in individuals who are obese and insulin resistant.~   "
18110|NCT02820285|"~     Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its~     strong increase in the last 20 years. Among the many complications associated with obesity,~     liver complications (steatosis and steatohepatitis [NASH]) are among the most common.~     Semaphorins were described in the early 1990. More than 20 types of these proteins have been~     reported to date. These proteins were used for neural development. Since many functions have~     also been described. The semaphorins are involved in numerous physiological or~     physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression),~     the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show~     that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and~     inflammation. Immune semaphorin are new players in the regulation of inflammation and immune~     reactions.~      The role of immune semaphorin in regulating inflammation in the two compartments (liver and~     adipose tissue) could be a crucial step that could lead to more severe liver damage. Its~     dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation~     of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic~     markers or future therapeutic targets.~   "
18111|NCT02820272|"~     Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound~     healing in complicated wound. However for many patients, the application and removal of the~     NPWT is source of procedural pain. Some techniques had been reported to reduce these pain~     such as administering topical lidocain or normal saline solution before the dressing change.~     The authors hypothesized that administering cold water into the NPWT sponge would decrease~     pain during dressing changes.~   "
18112|NCT02820259|"~     The purpose of this study is to demonstrate that the biliary concentration of TCR is a good~     marker of its immunosuppressive activity.~   "
18113|NCT02820246|"~     Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged~     hospital stay and delayed recovery. In these patients the incidence of complications such as~     nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In~     addition a relevant proportion of patients have a nutritional intake below their needs~     during hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at~     discharge up to 3 times more frequent when actual food intake was below 25% of calculated~     needs.~      The aim of this international cross-sectional multicentre audit and registry is to generate~     a risk and level of nutritional intervention profile for an individual unit/ward based on~     case-mix, nutrition care and available structures. This profile should give a snapshot on~     the relation of risk to resource allocation. The audit is unit centered. Each unit get as a~     feedback anonymously its position compared with all other participating units. Risk~     adjustment for selected patient groups, social environments and structures is planned.~      In conclusion this audit/registry will serve five distinct aims:~        -  Generate a precise map of the prevalence of malnutrition before admission and of~          decreased nutrient intake according to risk factors, medical specialty, organisational~          structures and countries.~        -  Increase in awareness for clinical nutrition in patients, caregiver and hospital~          managers.~        -  Enlarge and maintain a reference database for hospitalised patients~        -  Provide individual unit benchmarking~   "
18114|NCT02820233|"~     This study examines the role of the epidermal growth factor (EGF) receptor family and the~     EGF family of ligands in the regulation of non-myocytes isolated from the human heart.~   "
18115|NCT02820220|"~     Observational, cross sectional study, carried out with the help of a pre-designed and~     pre-tested questionnaire with the research hypothesis as: Knowledge and perception regarding~     JSSK and RBSK in nursing students is better as compared to in-service nurses as well as~     patients/patient attendants (attending LHMC and associated hospitals, New Delhi, India)~   "
18116|NCT02820207|"~     OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk~     factors for unstable carotid plaque. This study was designed to evaluate whether carotid~     intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced~     ultrasound (CEUS).~      METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared~     to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with~     CD34 and MMP9 staining.~   "
18117|NCT02820194|"~     The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT~     by means of a randomised, controlled trial in patients affected by inoperable colorectal~     liver metastases. The chosen comparator is MWA.~      The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term~     outcomes.~   "
18118|NCT02820181|"~     Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must~     be securely fixed to prevent movement or decannulation and tracheostomy ties must be~     exchanged as needed. However, the process of ties exchange is always risky and complicated.~     A novel tracheostomy tie has been designed to ensure the safety during exchanging and~     conveniences of cleaning. This study is to determine if the new device is better than the~     old one.~   "
18119|NCT02820168|"~     The purpose of this study is to create a human-readable and executable computer language to~     implement medical prescriptions and to evaluate and refine this language, with the goal of~     improving safety and efficacy of patient care.~   "
18120|NCT02820155|"~     This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and~     multiple dose study.~   "
18121|NCT02820142|"~     The incidence of acute kidney injury (AKI) among all hospitalized patients is approximately~     7%. Among these patients, sepsis and septic shock remain the most important cause of acute~     renal failure (ARF) and account for more than 50% of cases of AKI. The goal of this project~     is to uncover key factors that lead to renal function recovery. This study is planned to~     survey novel biomarkers that reflect tissue pathology or regeneration. During the~     hospitalization, blood and urine sample will be collected for NGAL and inflammatory marker~     analysis in the patients with bacteremia, while the rest sample will be collected for~     further novel biomarker survey. This study is to early predict the renal function impairment~     and identify the possible molecule that involved in renal function recovery.~   "
18122|NCT02820129|"~     This study evaluates whether or not the use of a medication wallet card in patients over 70~     taking 5 or more medications promotes self-efficacy with regards to coping with illness,~     understanding medications, and staying healthy. Half of the participants will receive an~     individualized medication wallet card with their medications and medical conditions listed~     while the other half will receive a simple reminder card.~   "
18123|NCT02820116|"~     This is an open-label, multicenter, single-arm, phase II interventional clinical trial~     evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA-~     IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage~     IIIA- IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be~     enrolled. EGFR mutation will be prospectively tested in all the participants' biopsy samples~     and confirmed in surgical resected samples.~      Neoadjuvant treatment phase:~      Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be~     scheduled to continue until the disease progression or unbearable toxicities appear.~      Surgery treatment phase:~      Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The~     patients with responsive disease considered to be technique resectable will undergo~     resection.~      Post-surgery phase:~      It is the discretion of the investigator whether the patient is a candidate for~     post-operative treatment which is considered to be in the best interest of the patients. It~     is recommended that patients with positive margins or residual tumor after surgery should~     receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest~     CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan~     (ECT) every 12 months -- for up to 5 years.~   "
18124|NCT02820103|"~     1. To test the effectiveness of the theory-based interventions (text+visual and text-only~          BCT-based interventions) against usual care in changing patients' intentions to phone~          ambulance immediately with symptoms of ACS ≥ 15 minutes duration.~        2. To determine the most effective mode of delivery by comparing the text+visual BCT-based~          intervention with text-only BCT-based intervention.~        3. To investigate any unintended consequences of the intervention on intentions to phone~          an ambulance for non-life-threatening symptoms.~   "
18125|NCT02820090|"~     Infection and trauma take a important role in the acute respiratory failure.There are~     different causes and degrees of inflammatory reaction in the critically ill patient. The~     inflammatory reaction should also affect patients on mechanical ventilation dependence with~     body physiological response and disease prognosis in patients. Therefore, the investigators~     hypothesize that inflammation may have an important role in the prediction of weaning from~     mechanical ventilation.~   "
18126|NCT02820077|"~     This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of~     bleeding from malignant lesions of the upper GI tract. Half of participants will receive~     hemostatic powder and half will be submitted to standard treatment.~   "
18127|NCT02820064|"~     Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic systemic hypoxia~     and low-grade inflammation as well as by an alteration of arginine (ARG) metabolism. As ARG~     is synthetized from circulating citrulline (CIT), an alteration of CIT homeostasis,~     particularly its production by ornithine transcarbamylase (OCT) in small intestine could be~     involved. We hypothesized that hypoxia +/- inflammation, classically associated to COPD, has~     effects on OCT regulation in enterocytes.~      This study aims at exploring the effects of hypoxia and inflammation on the production of~     citrulline by ornithine transcarbamylase (OTC) activity in enterocytes from explant cultures~     of duodenal tissue.~   "
18128|NCT02820051|"~     Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of~     respiratory diseases. Although midazolam is the recommended sedative agent by most~     guidelines, propofol has gained popularity due a short recovery time, however, evidence to~     propofol use for sedation during FB is scarce. There is little evidence about transcutaneous~     CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered~     by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough~     inhibition.~      The investigators performed a randomized controlled trial to determine whether~     non-anesthesiology-administered balanced-sedation with propofol was related to high values~     of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The~     investigators included data from outpatients 18 years or older with an indication for FB in~     a university hospital in northern of Mexico. Secondary outcomes were recuperation time,~     patient satisfaction and adverse effects.~   "
18129|NCT02820038|"~     The aim of the proposed project is to compare the effectiveness of two strategies designed~     to enhance patient understanding of medication risks/benefits: (1) Medication Guides,~     mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes,~     developed by Woloshin and Schwartz to enhance the usability of consumer medication~     information. The investigators will also assess whether the effectiveness of these~     communication strategies can be increased by Gist Reasoning Training, which is designed to~     enhance patients' ability to extract meaningful gist from complex information.The~     investigators anticipate enrolling 300 individuals with rheumatoid arthritis. The study will~     use a randomized controlled trial design with four study arms. Data will be collected~     primarily via self-administered, Internet-based surveys using REDCap. All participants will~     be followed for 6 months after the completion of baseline data collection.~   "
18130|NCT02820025|"~     The current study is designed to investigate the difference of plasma orexin A levels~     between doxapram group and controlled group at emergence time from sevoflurane-remifentanil~     anesthesia who will undergo elective lumbar surgery.~   "
18131|NCT02820012|"~     Although practiced for many years, surgical correction of scoliosis is relatively subject~     published for idiopathic scoliosis and a few published for other types of scoliosis.~      This study involves a creation of an observatory of patients undergoing scoliosis by ST2R~     reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ®~     system.~      The main objective is to analyze the three-dimensional correction of the deformity after~     intervention and its maintenance over time depending on the etiology of scoliosis.~      This research is conducted in pediatric surgery services specialized in this technique.~      Correcting radiographic parameters is directly related to the surgical procedure. The~     quality of life of patients is indirectly affected by the surgery. Secondary objectives are~     to analyze the surgical technique and to evaluate its impact on the quality of life of~     patients.~      This study will firstly to have a better understanding in:~        -  Scoliosis of the children and adolescents and their surgical treatment;~        -  The impact of the surgical procedure by the ST2R technique on the three-dimensional~          correction, and the patient's quality of life; and secondly, better management of~          patients requiring surgery for scoliosis as well as a public health impact.~   "
18132|NCT02819999|"~     The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline~     treatment of small cell lung cancer (SCLC).~   "
18133|NCT02819986|"~     The purpose of the present study is to determine the effectiveness and feasibility of the~     Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders.~     PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help~     individuals return to life roles including readiness to return to work. PGAP has been shown~     to be effective with some chronic health conditions however has not been specifically~     studied in mental health populations. The study consists of 10 one hour weekly therapy~     sessions that focus on reducing psychosocial risk factors that result in disability through~     the use of goal setting, activity planning and activation, monitoring and challenging~     thoughts about return to work, and problem solving. Participants will also be asked to~     complete short self-report questionnaires as well as a semi-structured interview about the~     participants anxiety, mood, impact of disability, and current functioning at the beginning~     of session one and within two weeks after session 10. Two short questionnaires will also be~     completed at each session measuring the degree to which the participants daily life impacts~     and is affected by anxiety or mood symptoms.~   "
18134|NCT02819973|"~     VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three~     specific research questions. In black patients eligible for a primary prevention implantable~     cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational~     video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated~     risk factors, and ICDs; 2) what is the effect of a patient-centered educational video~     compared with UC on the decision for ICD implantation, decisional conflict, and receipt of~     an ICD within 90 days of the decision; 3) what is the effect of racial concordance between~     study patients and video participants (health care providers/patients) on the decision for~     ICD implantation, decisional conflict and ICD receipt within 90 days of the decision. In~     addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be~     conducted to determine the salient influences on their decision and explore the reasons for~     their ultimate decision and subsequent implantation or non-implantation of an ICD.~      Approximately 480 patients eligible for a primary prevention ICD will be enrolled at~     approximately 12 hospitals in this study. Study sites selected for VIVID will be~     geographically diverse and provide care to a significant proportion of racial and ethnic~     minority patients. Patient's will be mailed a letter, regarding the study, prior to their~     initial visit. At the initial visit, patients will be approached about participation in the~     trial. For those interested, informed consent will be obtained and patients will be~     randomized. The investigators will be utilizing electronic consents on an iPad. Black~     patients will be randomized to one of 3 arms: educational videos presented in the same~     format; one with black participants (patients and providers) or the other with white~     participants (patients and providers); The third arm will be usual care (control) and the~     provider can interact with the patient consistent with their typical/usual care. Notably,~     for both intervention and control arms, all patient management decisions are completely at~     the discretion of the care providers.~   "
18135|NCT02819960|"~     Diarrhea is a relatively common complication in patients with cancer. At its inception,~     several mechanisms participated; malabsorption on the basis of mucositis induced by~     chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to~     infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites~     can also induce diarrhea directly due to effect on the intestinal mucosa.~      Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical~     assumptions and the results of several clinical trials. Lactic acid bacteria involved in the~     treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce~     bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects~     activation or deactivation of metabolites which cause diarrhea. Production of short chain~     fatty acids, which are important for the maintenance of intestinal mucosal cells also~     contributes to their antidiarrhoeal effect.~      This randomized, double-blind, placebo controlled, multicentre trial was designed to~     evaluate potential of probiotics to prevent grade 3-4 diarrhea in patients treated by~     irinotecan based chemotherapy during first 6 weeks of irinotecan based chemotherapy~   "
18136|NCT02819947|"~     To establish a new prospective cohort of Korean patients with systemic sclerosis and track~     the natural history of the disease over time.~      To generate new hypotheses for further investigation.~   "
18137|NCT02819934|"~     A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male~     Subjects~   "
18138|NCT02819921|"~     This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The~     purpose of this study is to determine if desvenlafaxine was effective in decreasing the~     frequency and severity of hot flashes in breast cancer patients taking tamoxifen.~   "
18139|NCT02819908|"~     To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular~     solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first~     week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).~      The hypothesis is that the dropless regimen will be non-inferior to the less drops~     regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.~   "
18140|NCT02819895|"~     The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a~     customized automated telephone and email immunization reminder system will be feasible,~     acceptable, and significantly improve immunization utilization rates.~   "
18141|NCT02819882|"~     This study is a prospective, multicenter non-interventional cohort study designed to develop~     a registry in unresectable locally advanced or metastatic disease.~   "
18142|NCT02819869|"~     The study demonstrated that either statin or metformin served as notable use in reducing the~     incidence of many cancers.~   "
18143|NCT02819856|"~     The primary objective of this study is to determine the safety and tolerability of SPI-1005~     treatment in CF patients with active pulmonary exacerbation that are receiving an IV course~     of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE)~     reporting, hematology (CBC) chemistry (Chem-20).~      The secondary objectives of this study are to determine the pharmacokinetics of oral~     SPI-1005 at 200, 400 and 600 mg BID for 14 days. Peak/trough assessments will be determined~     for ebselen, its major metabolite and selenium. Clinical assessments of the severity of~     sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and~     lung function will be made compared between treatment arms and the placebo arm of this~     study.~   "
18144|NCT02819843|"~     The purpose of this phase II clinical study is to test the good and bad effects of T-VEC~     (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with~     melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis.~   "
18174|NCT02819453|"~     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence~     against viral and bacterial stimuli by modulating the immune response. The aim of this study~     was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome~     and to investigate whether corticosteroid attenuate its levels.~   "
18192|NCT02819219|"~     This study will examine the effects of supplemental ElevATP with or without a blend of~     extended-release caffeine and B vitamins for changes in body composition, athletic~     performance, and hematology over a 12 week intervention period.~   "
18145|NCT02819830|"~     This study is investigating whether a six-week exercise training programme, designed for~     patients with Rheumatoid Arthritis, improves disease activity, inflammation,~     cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular~     disease. Twenty four patients will be randomly assigned to an intervention or control group~     (n=12 in each group). The intervention group will will undertake a fully supervised~     structured exercise training programme, consisting of both aerobic and strength training~     exercise, taking the form of two 70-minute group fitness classes per week for six weeks.~     These participants will also undertake a 30-minute walk in their own time. The control group~     will continue to go about their normal daily activities. Measurements will be made before~     and after the intervention/control period, including assessments of disease activity (e.g.,~     by gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS)~     ) and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a~     strength test, a flexibility test, Health Assessment Questionnaire Disability Index~     (HAQDI)). Blood samples will also be collected from patients before and after the~     intervention/control period to measure markers of inflammation, such as C-reactive protein~     (CRP) and Erythrocyte Sedimentation Rate (ESR). The investigators will also measure other~     parameters that are linked to type II diabetes (e.g., fasting glucose concentration) and~     factors implicated in cardiovascular disease risk (e.g., lipid profile and resting blood~     pressure).~   "
18146|NCT02819817|"~     This is a double blind placebo-controlled RCT comparing the speed of healing of simple~     traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard~     care.~   "
18147|NCT02819804|"~     The purpose of this research study is to determine the acceptable upper limit dose of~     nivolumab in combination with dasatinib that may be given to patients with~     relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).~     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but~     has not yet been investigated in Ph+ ALL. Dasatinib is currently FDA approved for the~     treatment of Ph+ ALL, but has not yet been investigated in combination with nivolumab for~     this disease. There is evidence that dasatinib not only blocks the Philadelphia chromosome~     or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL)~     mutation, but also increases the activity of cells in your immune system. Nivolumab~     increases T cells in your immune system, which allows your immune system to attack the~     cancer. We think the combination of these drugs will be more effective against your leukemia~     than either drug used alone.~   "
18148|NCT02819791|"~     The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux~     Hospital University) showed that following myocardial infarct (MI) or ischemic stroke (TIA~     or stroke), the global management (medical and educational) of patients led to very~     long-term satisfactory results in terms of reduction of cardiovascular (CV) risk and~     morbidity and mortality. However, the specific effect of therapeutic education beyond the~     conventional treatment has never been an adequate assessment. The following at 1 year of~     this study will show the evolution of chronic long-term CV disease in patients who received~     therapeutic education, and to explain the mechanisms. The challenge of this project is to~     demonstrate for the first time the superiority of therapeutic education and conventional~     care and propose a modeling program for national diffusion.~      Patients who experienced a CV event (MI, stroke) will be randomized into 2 groups of 165~     patients each: 1) receiving conventional treatment alone; 2) receiving conventional~     treatment + CEPTA program. The study was built for a 1-year follow-up period, to demonstrate~     the impact of therapeutic education on evolution of risk factors, physical, psychological~     and social health of patients. The main benefit of this study for the patient is the~     implementation of an optimized treatment and long-term monitoring by a cardiology referral~     center.~   "
18149|NCT02819778|"~     Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric~     emergency departments. So as not to overlook the risk of complications, which occur at a~     rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient~     observation are prescribed. Ultimately, the majority of these measures could be avoided and~     a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for~     children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in~     blood, such as the S100B protein, has the potential to reduce the number of these~     unnecessary measures.~   "
18150|NCT02819765|"~     This study aims to establish a biorepository and phenotyping database to investigate~     longitudinal changes in ALS subjects. Blood, including DNA and RNA, cerebrospinal fluid~     (CSF) and electrophysiologic measures will be collected every 3 months over 1 year. The~     database and specimen repository will be made available to ALS researchers on a merit basis.~   "
18151|NCT02819752|"~     This study aims to establish whether the combination of pembrolizumab (MK-3475) and~     conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels~     of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will~     provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as~     these are the primary acute toxicities associated with this treatment regimen. In addition,~     toxicity outside the radiation portals (which may theoretically be exacerbated by radiation)~     will be studied. However, all toxicity will be monitored. This study will also give an~     indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately~     selecting a group of patients with high- and intermediate-risk disease who have a~     significant chance of experiencing loco-regional or systemic failure.~   "
18152|NCT02819739|"~     The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass~     by his heart preconditioning effect is associated with a lower incidence of cardiac~     arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of~     myocardial ischemia-reperfusion injury in cardiac surgery postoperative.~   "
18153|NCT02819726|"~     This is a multicenter, randomized, double-blind, parallel group study to compare the PK, PD,~     safety, efficacy, tolerability, and immunogenicity of SAIT101 versus MabThera® versus~     Rituxan® in patients with RA. This study will take place globally across approximately 70~     study centers in order to randomize approximately 282 patients. The study consists of Part A~     from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety~     follow-up that also collects transition data.~   "
18155|NCT02819700|"~     Behavioural disorders are very common right from the initial stage of dementia and~     contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status~     due to their prevalence and their diagnostic importance, as they often constitute the~     initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's~     disease (HD) and they are classically more frequent in vascular dementia (VaD) than in~     Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive~     Impairment (MCI) has only been partially evaluated and would increase the risk of~     progression to dementia. These classical data are based on non-standardized assessments and~     non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions~     EXécutives (GREFEX) has developed a standardized assessment tool for behavioural~     dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has~     validated diagnostic criteria for this syndrome.~   "
18156|NCT02819687|"~     A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and~     multiple-ascending doses of RDX5791 in healthy male and female subjects.~   "
18157|NCT02819674|"~     Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for~     50% of cardiovascular morbidity and mortality, and also a substantial public health problem~     affecting approximately 1/4 of the adult population in industrialized societies and over 1~     billion people worldwide. Chronically elevated blood pressure without well control puts~     people at increased risk of target organ damages, including stroke, myocardial infarction,~     congestive heart failure, end-stage renal disease, blindness, and death. Especially, these~     damages are dramatically more severe in the early-onset hypertensive population.~   "
18158|NCT02819661|"~     The study will examine whether there is a difference in the frequencies of respiratory~     depression among obese women receiving spinal anesthesia combined with opioids compared to~     women with normal BMI.~      If such a risk exists further investigation will be required to establish the proper~     criteria for the administration of morphine with spinal anesthesia to obese women.~   "
18159|NCT02819648|"~     The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is~     to assess the effect of preoperative, single, oral dose of prednisolone on postoperative~     pain and medication intake in patients with symptomatic, irreversible pulpitis in mandibular~     molars.~   "
18160|NCT02819635|"~     This study comprises three sub-studies. The objective of sub-study 1 is to characterize the~     dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical~     remission in order to identify the induction dose of ABT-494 for further evaluation in~     sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494~     compared to placebo in inducing clinical remission in participants. The objective of~     sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in~     achieving clinical remission in participants who had a response following induction with~     ABT-494.~   "
18161|NCT02819622|"~     Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to~     thickened choroid mostly affecting young men under perceived stress. While most previous~     studies in CSCR have been retrospective and have focused on a single facet of the patient's~     personality, the investigators conducted a prospective intercontinental controlled study to~     analyze the multifaceted personality profile in CSCR.~      Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to~     participate in a questionnaire. Controls not having retinal disease were recruited from the~     same clinic.~      Main Outcome Measures: The main parameters registered were presence of stress, daily number~     of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).~      Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was~     from January 2015 to February 2016. Controls were matched for age, gender and race.~     Statistical analyses were done using univariate and multivariate analysis.~   "
18162|NCT02819609|"~     The purpose of this observational, retrospective database study of patients with uterine~     fibroids is to compare the durability of symptom relief after uterus-conserving treatments~     for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms~     and subsequent procedures and evaluate the effect stakeholder participation had on the~     research process.~   "
18163|NCT02819596|"~     This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab~     can be used alone or in combination to reduce the size of tumours in patients with kidney~     cancer.~      The drugs being tested in this study have an anti-tumour effect and have been tested in~     pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system~     to help the body fight against tumour cells with immune cells. Savolitinib works to correct~     a faulty signal which causes tumour growth.~      If a patient is eligible for the study and decides to take part, they will be enrolled into~     one of 3 stages of the study.~        -  First stage: aims to find the optimal dose of MEDI4736+savolitinib.~        -  Second stage: patients with papillary cell cancer will be treated with~          MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four~          treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or~          MEDI4736+tremelimumab.~        -  Third stage: patients will be tested for biomarkers before enrolment, and depending on~          the results will be allocated to one of 3 treatments (MEDI4736, savolitinib, or~          MEDI4736+tremelimumab) to see if certain biomarkers are linked to drug efficacy.~   "
18164|NCT02819583|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.~   "
18165|NCT02819570|"~     The objective of the study is to compare a new antibiotic protocol with the current~     prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome:~     preterm labor, chorioamnionitis and early onset sepsis~   "
18166|NCT02819557|"~     This is a Phase 2, multiple-dose, open-label study evaluating the safety, and~     pharmacokinetics (PK) of ataluren in patients aged ≥2 to <5 years old with Duchenne muscular~     dystrophy caused by a nonsense mutation in the dystrophin gene. The study includes a 4-week~     screening period, a 4-week study period, and a 48-week extension period for patients who~     complete the 4-week study period (52 weeks total treatment).~   "
19725|NCT02799017|"~     Participants will receive either intensive phonology or semantic feature analysis treatment~     for 16 weeks to improve naming, reading, and writing in individuals with chronic post-stroke~     aphasia.~   "
18167|NCT02819544|"~     Known to reduce analgesics and length of hospitalization in conventional surgery,~     laparoscopy is characterized by frequent post-operative pain and can decrease the patient's~     quality of immediate postoperative life and sometimes the results of decision ambulatory~     care.~      In order to reduce these postoperative pain, various methods have been evaluated in numerous~     studies to determine their analgesic role.~      As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally~     administered in the end of surgery to reduce postoperative pain and promote recovery of the~     patient. In addition, it is also possible to instill the anesthetic directly into the~     abdominal cavity reducing pain transmitted by nociceptor viscera.~      In recent years, new methods have been proposed such as lung recruitment maneuvers and the~     instillation of saline solution to reduce postoperative pain.~      However, no recommendation is on the use of intraperitoneal saline under the management of~     postoperative pain after laparoscopic cholecystectomy in ambulatory care.~   "
18168|NCT02819531|"~     Design: The proposed study is a randomized study comparing the relative effectiveness of~     three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs~     using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA)~     obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration~     of the study.~      Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and~     subsequent advancement of the RA burr. The RA system is performed using standard technique~     under intravenous infusion of heparin. The atherectomy burr size will be determined by the~     operator.~      Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent~     advancement of the OAS according to the manufacturer's guidelines.~      Control: Patients who are randomized to SBS will undergo coronary wiring and balloon~     inflation with SBS performed by standard technique under intravenous infusion of heparin.~     SBS will be used according to the AngioSculpt manufacturer's guidelines.~      Duration: 30 days follow-up.~      The primary trial objective is to determine which of the three treatment strategies for~     treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio~     of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT~     (primary study endpoint).~      The secondary objectives are to compare the following:~        1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as~          determined by IVUS or OCT (secondary endpoint)~        2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)~        3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined~          by quantitative coronary angiography (secondary endpoint)~        4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel~          revascularization) during 30 days of follow-up (secondary endpoints)~        5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)~   "
18169|NCT02819518|"~     The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in~     combination with one of three different chemotherapies will be assessed in the treatment of~     locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has~     not been previously treated with chemotherapy. In Part 2, the safety and efficacy of~     pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of~     placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic~     TNBC, which has not been previously treated with chemotherapy.~      The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs~     Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and~     in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs~     Overall Survival (OS) compared to placebo and chemotherapy in all participants and in~     participants with PD-L1 positive tumors.~   "
18170|NCT02819505|"~     Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the~     extension of physical exercise, counteracting the decline in muscle performance due to~     fatigue. However this process is largely restricted by the levels of β-alanine available in~     the human body. Carnosine levels can be raised through long term ingestion of food products,~     such as meat, fish and poultry, however it can also be significantly increased by β-alanine~     supplementation. Improved β-alanine levels can potentially advance exercise capacity and~     exercise performance, which may have been previously limited. Recently research has~     demonstrated no beneficial effect of β-alanine supplementation on neuromuscular performance~     in active, healthy males when they were well rested, with no prior exercise or fatigue of~     the assessed muscle. It remains unknown if β-alanine supplementation would aid physical~     performance when the muscle has already been fatigued. This is currently being investigated~     in older adults (60-80 years), however there is no clear comparison between the potential~     effects in younger and older participants.~      Therefore this investigation hopes to examine the effects of 4 week β-alanine~     supplementation on lower limb contractile and force properties, pre and post muscle specific~     fatigue in 18-30 year old males.~   "
18171|NCT02819492|"~     Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it~     is mandatory to spend a long enough time investigating the colonic mucosa. A minimum~     observation time of 6 minutes has been proposed as a quality criterion for screening~     colonoscopy. However, different locations of the colon (proximal, distal) may require~     specific observation time periods. The colon can be divided into a proximal (right) and~     distal (left) part. Until now, it is unclear whether observation time has a significant~     impact on adenoma detection in both parts of the colon. The aim of this study therefore is~     to conduct a trial in which side-specific observation times and adenoma detection rates are~     measured in order to investigate this correlation in particular for the right colon.~   "
18172|NCT02819479|"~     To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the~     treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given~     intra-arterially after osmotic blood-brain-barrier disruption.~   "
18173|NCT02819466|"~     Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence~     (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high~     morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to~     passage of the gastric contents into the unprotected upper airways during general~     anaesthesia. The prognosis depends on three factors: the presence of food debris, and the~     acidity and volume of the gastric contents. To prevent this complication, the French society~     of anaesthesia and intensive care recommends preoperative fasting rules and, in patients~     presenting risk factors for aspiration, the use of antacids and rapid sequence intubation.~     This preventive strategy is associated with certain adverse events: deferred operative~     procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic~     complications, and memory of anaesthetic induction.~      Over recent years, ultrasound has become more widely used by anaesthetists for local~     anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D~     ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of~     intragastric volume presents several limitations: because of the complex shape of the~     stomach, this technique requires a long learning curve and the measured volume is poorly~     correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently~     measured intragastric volume by three dimensional ultrasound with promising results.~   "
18176|NCT02819427|"~     This study, conducted in children with typical or atypical absence epilepsy, will consist~     of noninvasive recording of the metabolic activity of the brain concomitantly with~     electroencephalographic recording during seizures without the need for any additional~     examination. This examination will be performed by combining near-infrared spectroscopy~     (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution~     (HR) recording.~      Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from~     a functional point of view and is used in the routine follow-up of epileptic children.~     Optical imaging is a recent and promising medical imaging technique, which uses~     near-infrared light. This rapid, noninvasive and harmless quantitative technique can be~     easily used at the child's bedside or in the ward and provides metabolic information on~     brain functioning.~   "
18177|NCT02819414|"~     The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate~     remains controversial. Currently it is generally accepted to treat only hemodynamically~     significant PDAs. The current investigation aims to study the effect of treatment on PDAs of~     borderline significance via a prospective, randomized controlled trial of paracetamol in~     this group.~   "
18178|NCT02819401|"~     The present study is designed to determine the gastrointestinal tolerability of enteral~     nutritional products, physicians and parents' overall perception of enteral nutrition~     products as well as providing basic demographic information on pediatric populations~     prescribed these formula for supportive treatment as part of the routine healthcare service~     in Turkey.~   "
18179|NCT02819388|"~     This study evaluates the effects of a community-based counseling intervention to improve~     contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of~     the participants received contraceptive counseling at the community setting, while the other~     half acted as a control group.~   "
18180|NCT02819375|"~     Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and~     other psychiatric diseases. Currently, most ECT procedures are carried out with muscle~     paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic~     drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to~     establish an accurate balance between adequate anaesthesia depth and optimal seizure~     duration.~      We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone,~     propofol with remifentanil and propofol with ketamine), with respect to seizure duration and~     seizure quality in patients undergoing electroconvulsive therapy.~   "
18181|NCT02819362|"~     Benefit of MRI in pathological nipple discharge.~   "
18182|NCT02819349|"~     The purpose of this study is to examine whether Texting for Relapse Prevention (T4RP), a~     text messaging-based early warming for relapse prevention in people who have~     schizophrenia/SAD, is associated with fewer relapse symptoms compared to a~     treatment-as-usual control group.~   "
18183|NCT02819336|"~     This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture~     therapy for the post-stroke patients with urinary incontinence.~   "
18184|NCT02819323|"~     The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a~     PEG based preparation prior to colonoscopy in adolescent patients.~   "
18185|NCT02819310|"~     The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in~     constipated adults.~   "
18186|NCT02819297|"~     The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and~     efficacy versus placebo in constipated adults.~   "
18187|NCT02819284|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
18188|NCT02819271|"~     This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy~     volunteers.~   "
18189|NCT02819258|"~     Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the~     canal opening with a hermetic sealing material.~      The analysis of the literature on intracanal therapeutic shows great variability of the~     results obtained, the reported success rate is 53 to 95%.~      This is explained by the difficulty of the surgical procedure, but also by the multiplicity~     of possible factors of failure, related practitioner, canal anatomy, the operating~     procedures, the preparation techniques and root canal filling. This success rate is variable~     depending on the presence or absence of periapical pathology before treatment: more than 85%~     for teeth treated without initial periapical pathology against only 62% for teeth with~     pathology before treatment. Furthermore, the literature review revealed two contradictory~     assumptions about the dominant factor failure in endodontics: the failure of the sealing~     canal system (bad level shutter) against the failure of the endovascular disinfection.~      Main hypothesis of the research objectives:~      The probability of success in a year endodontic treatments carried out according to the~     recommendations and the operating standards on teeth with periapical pathology is~     approximately 60%.~      The primary prognostic factors would be the existence of intracanal obstacles (stop~     calcification ...) responsible for a sub-obturation of the canal, factors inherent to the~     tooth (situation ductal anatomy and complexity), the operating techniques used, the~     practitioner ( skill level), the quality of the restoration.~   "
18190|NCT02819245|"~     This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and~     try to find how the age will impact the surgical outcome of AIS.~   "
18191|NCT02819232|"~     Infectious keratitis are favored by the circumstances causing the small trauma of the~     corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's~     syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the~     majority of infectious keratitis are favourable, some lead to serious injury of the cornea,~     or even corneal perforation which result an endophthalmitis. This unfavourable evolution may~     lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the~     eyeball. This negative evolution is encountered while the infectious keratitis due to~     tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal~     infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The~     microbiological diagnosis of routine is based on the systematic search for pathogens tedious~     from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab~     diagnostic method.~   "
18193|NCT02819206|"~     Our research project is to use a new microbiological diagnostic strategy of uveitis,~     allowing detection of the fastidious pathogens of infectious Uveitis who are not diagnosed~     by laboratory methods used in diagnostic routine. This new diagnostic strategy is to~     automatically detect the presence of a pathogen fastidious in cell culture using the same~     patient's serum to reveal a positive culture, based on the assumption that this serum~     contains antibodies specific pathogen tedious.~      Finally, the main purpose of this study is to improve the etiological diagnosis of Uveitis~     by establishing a new diagnostic strategy.~   "
18194|NCT02819193|"~     Despite the importance of breast milk for sick or preterm neonates, there is currently no~     consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of~     this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate~     the association between early use of raw MOM and breastfeeding continuation at discharge and~     up to 6 months later.~   "
18195|NCT02819180|"~     Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza~     vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and~     elderly older than 60 years of age.~   "
18196|NCT02819167|"~     Ischemic strokes are one of the leading causes of handicap and death in elderly people in~     France.~      Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual~     activities and other environmental factors that explain differential susceptibility to~     functional impairment in the presence of pathology or other neurological insult. CR is~     estimated using variables for cognitive activity: years of education, professional status,~     socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model~     that depend on brain size and other quantitative aspects of the brain that explain~     differential susceptibility to functional impairment in the presence of pathology.~      Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to~     brain injury. On the other hand, CR influences the severity and the expression of cognitive~     diseases.~      The investigators realize a prospective study in order to assess the impact of CR and BR on~     cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly~     patients.~   "
18197|NCT02819154|"~     Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened~     with a high mortality rate. Invasive methods of resuscitation and the diseases treated can~     lead to serious sequelae. Follow-up studies of patients at hospital discharge report most~     often the quality of life using validated quantitative scales. A recent consensus of the~     American Society of resuscitation an update on the physical, cognitive and psychological~     sequelae of ICU hospitalization for the family and the patient, grouped under the term~     post-intensive care syndrome. Social changes, emotional and professional are little~     studied and are not part of the information provided by the quality of life questionnaires.~     The investigators hypothesize that intensive care stay entails a profound effect on the~     lives of patients. This study will add additional data on a little known aspect of post~     resuscitation.~   "
18198|NCT02819141|"~     The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for~     the self-management of sedative therapy (SMST) in a sample of critically ill patients~     receiving mechanical ventilator support. The investigators hypothesis is that~     self-management of sedative therapy by mechanically ventilated patients in the intensive~     care unit (ICU), tailored to their individual needs will be more efficacious than~     nurse-administered sedative therapy in reducing anxiety, which may reduce duration of~     mechanical ventilator support and occurrence of delirium.~   "
18199|NCT02819128|"~     Hypothesis:~      Homeless people have infections not diagnosed with a potential impact on their health~     status.~      Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among~     homeless people.~   "
18200|NCT02819115|"~     Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal~     vaccine.~   "
18201|NCT02819102|"~     This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic~     and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.~     Pharmacokinetics of the probe substrate drugs will be measured prior to and following~     administration of multiple doses of BCX7353.~   "
18202|NCT02819089|"~     The purpose of this study is to determine the recovery profiles after general anesthesia in~     patient undergoing anterior cervical spine surgery. This study will compare the Riker~     sedation agitation scores between two groups, with or without dexmedetomidine as an~     anesthetic adjuvant.~   "
18203|NCT02819076|"~     Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn,~     especially after a birth injury, but it is sometimes difficult ti define.~      There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data~     available are those of the perinatal survey 2010, with the number of operative vaginal~     deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the~     seat (4.7%). These delivery modes can be purveyors of pain.~      At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions~     by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013,~     and 15 in the delivery room. But this consumption is a poor reflection of the pain because~     treatment could be given pain-authenticated (measured with the EDIN scale), and because a~     bottle is discarded one month after opening.~      The scales measuring pain used in the new-born at term based on the assessment of change in~     behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale~     Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related~     to health care.~      The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in~     children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute~     or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant~     proportion of newborns. This scale appears suitable for evaluation of the newborn to term~     maternity~   "
18204|NCT02819050|"~     Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of~     non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not~     well established. In this prospective, two-center randomized control trial we hypothesize~     that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP~     off in infants born between 23 0/7-30 6/7 weeks of gestational age.~   "
19735|NCT02798887|"~     Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane~     Approach to Grafting.~   "
18205|NCT02819037|"~     The objective of this research is to determine the incidence of microbial overgrowth of the~     small intestine before and after a gastric bypass. For this purpose, the study is based on~     the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3,~     6, 12, 18 and 24 months.~   "
18206|NCT02819024|"~     This pilot research trial studies the effects of dexamethasone in patients with advanced~     non-small cell lung cancer that has not responded after previous treatment. Drugs such as~     dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as~     fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive~     substance to show changes in tumor cells. Studying the effects of dexamethasone on lung~     tumors using FLT positron emission tomography may help doctors plan better treatments.~   "
18207|NCT02819011|"~     The investigators propose a randomized control trial to evaluate long term effects and~     effectiveness of Ankle foot orthoses (AFO) in reducing risk of falling in older adults.~      Primary Endpoints • Characterize the impact of AFO on balance, gait, risk of falling,~     frailty status, and adverse events~      Secondary Endpoints • Characterize the Impact of AFO on spontaneous daily physical~     activities • Characterize the feasibility of the AFO device on patient adherence,~     acceptability, user-friendliness, and perception of benefit for daily usage~   "
18208|NCT02818998|"~     To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different~     intravitreal (IVT) treatment regimens to subjects with DME pretreated with 2 mg aflibercept~     every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according~     to the EU label for the first year of treatment)~   "
18209|NCT02818985|"~     Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.~   "
18210|NCT02818972|"~     Investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects~     with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the~     descending thoracic aorta.~   "
18211|NCT02818959|"~     The objective of this study is to evaluate feasibility, safety and effectiveness of the~     first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve~     TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis~     who are at high risk for surgical aortic valve replacement.~   "
18212|NCT02818946|"~     The purpose of the proposed prospective study is to determine the diagnostic value of MRI~     for the evaluation of patients with pathologic nipple discharge. Breast surgeons will~     identify clinic patients with pathologic nipple discharge (unilateral and bloody or~     unilateral and clear) and refer them for breast MRI. When the clinical team notifies the~     study team that an MRI has been ordered for that purpose, the study team will consent~     patients to document the results and follow-up. The study team will not be obtaining MRI's~     on patients for research purposes only. The following data will be collected and analyzed:~     patient age, characteristics of the discharge (laterality, spontaneous versus expressed,~     duration of time, color, presence of blood), imaging workup and findings, BI-RADS final~     assessment categories, pathology results from core biopsy and/or surgical excision, and~     clinical and radiologic follow-up data during the two years after presentation.~     Participation in this study poses minimal risk to patients. Risks to the subjects include~     loss of confidentiality and unnecessary breast biopsy. The risks associated with MRI are~     minimal; however, since a gadolinium-based contrast agent will be administered for the MRI,~     patients with compromised renal function and patients who are pregnant will be excluded from~     the study.~   "
18213|NCT02818933|"~     The purpose of this pilot study is to assess the quality of self-report data obtained using~     the Automated Self Administered 24-Hour Recall (ASA24-Kids-2014) relative to an interviewer~     administered 24-hour recall in a sample of adolescents ages 12-17 years, to determine their~     method preference, and to assess issues related to each method.~   "
18214|NCT02818920|"~     This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab~     administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery~     (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a~     type of immunotherapy that may enhance the ability of the immune system to fight off cancer.~     The study will investigate the effects of pembrolizumab on the immune system and how certain~     immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab.~     Previous studies suggest that pembrolizumab could alter the immune cells in a way that the~     the immune cells identify cancer cells. Pembrolizumab has been approved for the treatment of~     advanced lung cancer, but is investigational in this setting.~   "
18215|NCT02818907|"~     This study aims to collect clinical, biological and quality of life data from patients with~     a borderline or resectable pancreatic cancer. It will collect information from the date of~     diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end~     of the treatment. The database will be updated at each patient's visit. Biological samples~     will include: tumor, and plasma. Epidemiological data will also be collected, whereas~     Quality of life will be assessed by the EORTC standard. The objectives of this database are~     to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high~     quality standard research protocol.~   "
18216|NCT02818894|"~     Spinal anesthesia is commonly used in patients undergoing total hip replacements. The~     purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients~     having a total hip arthroplasty (THA). The objective of this study is to compare the two~     spinal anesthesia treatments in regards to transient neurological symptoms (TNS).~   "
18217|NCT02818881|"~     This study examined the muscle activity, movement patterns, and oxygen consumption during a~     series of yoga poses with slow and rapid transitions.~   "
18218|NCT02818868|"~     The aim of this study is to investigate the clinical events of the patients with acute~     cerebral large vessel occlusion or stenosis and atrial fibrillation, treated by apixaban~     within 14 days after onset. This is the observational study that patients will be made the~     registration at the timing of both retrospective period and prospective period.~   "
18226|NCT02818764|"~     The overall objective of this study is to test for perturbations in intraoperative~     electroencephalogram (EEG) , cerebral blood flow (CBF), cerebral metabolic rate of oxygen~     consumption (CMRO2), oxygen extraction fraction (OEF), and serum and cerebral spinal fluid~     biomarkers associated with delirium in high risk population having elective hip arthroplasty~     at Penn Presbyterian Medical Center (PPMC).~   "
18219|NCT02818855|"~     Gingival recession (GR) is frequently associated with deterioration in dental esthetics and~     dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when~     the root is covered and the gain in the width of keratinized tissue (KT) is expected, the~     use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced~     flaps (CAF) appears to be more predictable, and may be considered the gold standard~     procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs~     because of the need for a donor surgical area, which may increase the risk of surgical~     complications like bleeding, as well as increases post-operative discomfort and the period~     of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as~     a substitute for the SCTG. The use of CM was associated with a significant reduction in~     post-operative morbidity, less post-operative pain and discomfort in the patient, and more~     esthetic satisfaction.~   "
18220|NCT02818842|"~     Medication during pregnancy can lead to the occurrence of birth defects or neonatal~     pathologies. Thalidomide or diethylstilbestrol (Distilbene °) are prominent examples. Many~     drugs remain insufficiently evaluated in this area and doctors are too often deprived of~     relevant information when prescribing drugs in pregnant women.~      To fill this gap, the investigators have put in place since 2004, a database, EFEMERIS,~     recording products given to women during pregnancy in Haute-Garonne (data from Primary~     Health Insurance Fund), fate of these pregnancies and the state health of newborns (Mother~     and child protection data, prenatal Diagnostic Centre and Medicalisation Program of~     Information Systems data).~      Women included in this database (> 90 000 to date) has allowed us to study the risks of~     taking certain medications still not assessed in pregnant women (for example phloroglucinol,~     the H1N1 flu vaccine , oseltamivir ...). Each year about 10 000 pregnant women join the~     cohort. The collection and management of data concerning require careful organization and~     mobilize multiple stakeholders.~      The pursuit of these inclusions is needed to study medication less often prescribed but~     raise questions. For example, if the investigators consider that the relative risk of~     cardiac abnormalities following in utero exposure to paroxetine is multiplied by 1.5, it~     will take 1,000 women exposed to paroxetine for 5 additional cases observed. In December~     2013, 0.3% of women EFEMERIS were exposed to paroxetine in the first quarter (274 women).~      The objective of this project is to continue the EFEMERIS project (funded for 10 years~     public tenders until December 2015) by continuing to include pregnant women (about 10 000~     per year) in order to explore the potential effects of exposure to different drugs on the~     newborn (prematurity, birth defects, neonatal diseases).~      The processing of data will EFEMERIS to detect drugs at risk to the fetus and provide a~     warning role in terms of malformation effects, to monitor over time prescribing practices,~     participate in pharmacoepidemiology international multicenter studies including similar~     databases in general population.~   "
18221|NCT02818829|"~     BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national~     institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This~     base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA~     and RNA from tumors cells.~      The mission of this prospective project is to make available to the scientific community a~     clinical biological base from patients with pancreatic adenocarcinoma~   "
18222|NCT02818816|"~     Patients with prostate cancer undergoing robot assisted radical laparoscopic prostatectomy~     (RALP) in steep Trendelenburg position (sTBURG) are noted to have elevated intraocular~     pressures (IOP) intraoperatively. One study showed an increase in IOP of 13 millimeters of~     mercury (mmHg) from baseline IOP levels intraoperatively. Other studies have shown the IOP~     to more than double intraoperatively during RALP in sTBURG. IOP is found to be directly~     related to angle of inclination and increases time dependently with sTBURG. The IOP may~     remain significantly elevated until the first postoperative day after RALP.~      There are no previously published data concerning the safe threshold for IOP elevation and~     the effects of this increased IOP on vision and on generalized eye health are still not~     entirely known. One study showed postoperative visual field defects in 28% (7/25) of~     patients who underwent RALP in sTBURG. It has been theorized that sTBURG and subsequent~     increased IOP are risk factors for postoperative vision loss (PVL). It is believed that the~     increased IOP decreases optic nerve perfusion pressure causing ischemic optic neuropathy.~     Some previously recommended ways to reduce the intraoperative IOP spike during RALP include~     shorter operating times, decreased angle of inclination, modified Trendelenburg position,~     use of Propofol for maintenance anaesthesia and intraoperative topical hypotensive agents to~     reduce IOP. Given the challenges with some of the above options, this study aims to evaluate~     the effect of pre-operative treatment with topical Brimonidine Tartrate 0.2% on the IOP of~     patients undergoing RALP with sTBURG. The goal is to prevent the anticipated IOP spike~     thereby reducing risk of postoperative vision loss.~   "
18223|NCT02818803|"~     The purpose of this study is to evaluate the efficacy and safety of propolis on the~     treatment of oral candidiasis, more specifically denture stomatitis. Half of participants~     will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will~     receive miconazole gel, both for oral use.~   "
18224|NCT02818790|"~     The goal of the MI field test is to assess users' overall satisfaction, usability and~     acceptability of the PRECIOUS system, and to explore if MI in combination with gamification~     principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is~     pursued to trigger behavior change and build up motivation to maintain sustained change~     towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be~     carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore~     users' acceptance of PRECIOUS system in an early stage of its development. Considering that~     this is a pilot test, feedback and outcomes obtained will serve to refine and adjust~     PRECIOUS system concept and architecture.~   "
18225|NCT02818777|"~     There are two stages in the study. The major purpose of the Stage 1 is to study the safety~     and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol~     (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is~     based on their experience. This is an open label study in 10 subjects, during which the dose~     is gradually increased to the manufacturers recommended target dose, with tolerability being~     evaluated at each dose level. Based on the response of subjects in the Stage 1, a target~     dose is determined for the next stage. Standardized tools will be administered to study both~     tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look~     for an effect that warrants specific or different evaluation in the next stage.~      The major purpose of Stage 2 is to assess the safety and tolerability of the GWP42003-P at~     the determined dose, and secondarily to study efficacy, particularly regarding tremor. Stage~     2 is a crossover, double-blind, randomized controlled trial (RCT) with 50 subjects.~   "
18238|NCT02818608|"~     The aim of this study is to verify the effects of the Transcranial Direct Current~     Stimulation (tDCS), Functional Electrical Stimulation (FES), and the combination of both~     therapies (tDCS + FES) for rehabilitation of chronic stroke patients.~   "
18227|NCT02818751|"~     Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents with Anxiety.~     To determine the effects of escitalopram on functional activation patterns during a~     Continuous Performance Task with Emotional and Neutral Distracters, the CPT-END. To examine~     baseline functional activity and functional connectivity profiles in the ventrolateral~     prefrontal cortex as markers of subsequent treatment response to escitalopram in adolescents~     with generalized anxiety disorder (GAD). To use proton magnetic resonance spectroscopy (1H~     MRS) to examine glutamatergic and γ-aminobutyric acid (GABA)-related abnormalities in the~     anterior cingulate in adolescents with GAD as compared to healthy adolescents.~   "
18228|NCT02818738|"~     Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most~     patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim~     of this study is to assess the efficiency of a 6-months levamisole course, given early after~     first remission, on maintaining a relapse-free course at 12 months.~   "
18229|NCT02818725|"~     OBJECTIVES OF THE TRIAL~      Primary objective~      Evaluation of efficacy in terms of progression-free survival at 9 months of the combination~     of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without~     panitumumab as first-line treatment of advanced urothelial carcinoma in patients without~     Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.~      Secondary objectives~        -  To assess toxicity~        -  To assess response rate~        -  To assess overall survival~        -  To assess time to progression~        -  To study the correlation between response rate, time to progression, overall survival~          and biological parameters~   "
18230|NCT02818712|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality.~     Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known~     about the properties of recently developed HRQL questionnaires and about the longitudinal~     changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on~     patients with IPF, but reports differ in incidence and prevalence. The impact of~     comorbidities on HRQL and disease progression has only been studied sparsely. Also, the~     association between biomarkers and disease progression need to be examined further.~   "
18231|NCT02818699|"~     The purpose of this clinical study is to determine the effect and safety of long-term intake~     of enzymatically modified isoquercitrin (EMIQ), a natural plant product on body fat loss in~     obese and overweight individuals.~   "
18232|NCT02818686|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28~     days. This exploratory study will also serve as a signal seeking endeavor to demonstrate~     biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic,~     and histologic assessments.~   "
18233|NCT02818673|"~     Refractory ascites is an indication for liver transplantation, and includes ascites that is~     resistant to, or intractable by diuretic therapy (International Ascites Club). This~     definition is partly subjective; it can be established only a posteriori, following diuretic~     therapy administration to all patients, including those in whom untoward effects are~     prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would~     avoid giving diuretic therapy to patients in whom it will fail and identify rapidly~     candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic~     (PK) study of radiolabeled albumin between the peritoneal cavity and serum.~   "
18234|NCT02818660|"~     There are two main stimulation tests used to decide if a patient has cortisol deficiency. It~     is the synacthen test, were we stimulate the patient with intramuscular or intravenous~     synacthen ( ACTH) to see how much cortisol the adrenals are capable of producing, and it is~     the Insulin hypoglycemia test were we give the patient insulin to provoke a hypoglycemia,~     and look at the adrenal response to that stimulus. The cut off values for a normal response~     is based on old immunological assays no longer in use. Assays with a lot of interference and~     cross reactivity leading to measurement of higher values for cortisol than what we measure~     on the highly specific LCMS/MS ( Liquid chromatography mass spectrometry methode) that we~     are using for cortisol today. So, there is a need for new cut off values for a normal~     response to such tests. The purpose of this study is to produce such new cutoff values by~     performing the test in 120 healthy controls. We also want to perform the test in patient~     groups normally going trough this tests according to the same protocol as the control~     persons, to evaluate the new cutoffs in different patient groups.~   "
18235|NCT02818647|"~     Patients 13-years-or older who undergo tonsillectomy operation (without another additional~     surgery) will be enrolled in the study. Randomly, one side is going to be operated with~     conventional cold-knife technique and hemostasis will be maintained with bipolar diathermy~     (25-30w). Contralateral tonsil is going to be operated with needle-tip monopolar~     electrocautery (10-12w) at Blend 1 mode and hemostasis will also be maintained with~     needle-tip monopolar cautery. Postoperative tonsillar fossa healing and pain is going to be~     evaluated for both sides separately with Visual Analogue Scale. All operations are going to~     be performed by a single surgeon and all evaluations are going to be carried out by another~     surgeon in a totally blinded fashion to avoid possible bias.~   "
18236|NCT02818634|"~     The purpose of this study was to investigate the effect of 'muscle sparing technique' while~     harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative~     pain. Although authors report 'muscle sparing technique' cause less pain its not~     investigated in an evidence-based-medicine perspective. Therefore the investigators are~     planning a controlled, prospective clinical trial to compare the conventional method and~     'muscle sparing technique'.~      Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle~     Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial~   "
18237|NCT02818621|"~     Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and~     opioid requirements due to its sedative and analgesic properties. However, until now, there~     has been studies based on indirect measures such as hemodynamics. Entropy shows to quantify~     the level of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect~     of pain stimuli and analgesic therapy by the index of the nociception-anti-nociception~     balance. The investigators analyzed quantitatively the requirements of propofol and~     remifentanil under continuous infusion of dexmedetomidine when using entropy and SPI.~   "
18239|NCT02818595|"~     Many cognitive functions in humans are based on asymmetrical brain networks. For example, in~     most adults, the language is essentially processed by the left hemisphere, while other~     auditory functions, such as voice recognition, tend to be processed by the right hemisphere.~     Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the~     presence of anatomical and functional asymmetries by the first months of life. What are the~     causes of these asymmetries? How do they develop? Are they necessary for functioning or~     effective learning?~      This study, conducted in collaboration with the Compiègne applied mathematics team~     (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the~     stage of development at which hemispheric dominance for voice recognition is first observed~     and to identify the brain structure involved in preterm neonates whose sound environment is~     usually very different from that of the foetus. The impact of this environment on the~     infant's brain development and early learning will be evaluated.~   "
18240|NCT02818582|"~     Background:~      Some people have Ebola virus in their body for months after they recover from Ebola virus~     disease. Some may have health problems from the virus while others are fine. These people~     may be able to pass the virus to others. There are currently no drugs for people who have~     survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734,~     might help get rid of Ebola virus in semen.~      Objective:~      To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.~      Eligibility:~      Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the~     Ebola virus in their semen~      Design:~      Participants will be screened with:~      Questions~      Physical exam~      Eye exam~      Blood tests~      2 semen samples if they have not had it tested recently~      Participants must live near the study site in Liberia for 6 months.~      Participants will be put into 1 of 2 study groups. They will have an infusion of either~     GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The~     infusion lasts 1 hour.~      Participants will be observed for 1 hour after. They will provide a semen sample on infusion~     day 4.~      After the infusions, participants will have 5 visits in the first month, then 1 per month~     for 5 more months. These include giving a blood and semen sample.~      Blood tests are performed before and after each infusion and the last visit (5 month visit)~     will also include an eye exam.~      When the study is over, if the study drug works and is safe, participants who got the~     placebo can get the study drug.~   "
18241|NCT02818569|"~     The broad objective of this investigation is to assess the safety and efficacy of oral~     therapy with dexmedetomidine for the induction and maintenance of restful sleep.~   "
18242|NCT02818556|"~     This will be a single-center, randomized, evaluator-blinded, split-face clinical study~     design. Fifty patients will receive one treatment session consisting of Restylane® Silk~     (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose~     conversion ratio) injections to the superficial, vertical perioral lines. Injections will be~     performed at the baseline visit. To ensure subject and investigator blinding, syringes will~     be prepared and labeled 1 and 2 immediately before subject attendance for injection by~     the sub-investigator. The same injection sites and techniques will be used on both sides of~     the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150,~     180.~   "
18243|NCT02818543|"~     The purpose of this study to assess the pharmacokinetic profile in patients with active~     ulcerative colitis and compare it to the experience in healthy volunteers.~   "
18244|NCT02818530|"~     Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position~     and studies showed that IOP reaches peak levels after steep Trendelenberg position on an~     average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are~     aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle~     tone.~      Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the~     anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They~     concluded that bedside ultrasound could be useful in evaluating patient with suspected~     increased IOP, who are unable to open their eyes.~   "
18245|NCT02818517|"~     The survival rate of cancer patients has greatly increased over the past decades' mainly due~     to early detection and the use of new medications with higher doses and combined protocols.~     This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction~     ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the~     long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for~     many types of cancer. As a result of the increasing number of long-term cancer survivors the~     magnitude of this problem is growing. Early identification of cardio toxicity can be~     identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers~     (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the~     addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the~     patient's treatment may prevent the development of cardiac dysfunction. However, currently~     there are no specific or clear guidelines for the follow-up and management of~     cardio-toxicity in cancer patients.~      The aim of the study: To try to identify who are the patients at increased risk for~     developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and~     echocardiogram examination, in purpose of early diagnosis, management and prevention of~     cardiac events. For achieving this the investigators will build a registry which will~     include all the oncologic patients going an evaluation in the cardio-oncology clinic in the~     Tel Aviv Medical Center .~   "
18254|NCT02818400|"~     In hindsight, the first face graft raises the fundamental problem of composite tissue~     allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific~     technical and philosophical problems.~      By proposing a prospective study concerning five new patients over the next three years, in~     the light of this first experience, the authors would like to confirm the surgical~     feasibility of this type of procedure, possibly extending it to other parts of the face~     (lateral third) and, like English and American teams, considering the possibility of total~     facial surface reconstruction.~      In parallel, and while complying with the usual immunosuppression procedures, the deliberate~     choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin~     and quantity of which will need to be determined) will be reaffirmed, in order to improve~     mucocutaneous tissue tolerance, while confirming the safety of this type of approach.~      Five new cases will also provide observations for the many new fields of research developing~     around composite tissue transplants (neurophysiology, skin histopathology, psychiatry,~     haematology, immunology, etc.).~   "
18246|NCT02818504|"~     Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse,~     high blood lipids or sugar and arterial hypertension. Systems for self-learning and~     self-monitoring may help people improve and maintain a healthy lifestyle through tailored~     suggestions about diet, weight control, physical activity, fatigue,stress.~      SEMEOTICONS exploits the human face as an indicator of individual's health status and~     translates signs obtained from the face using contactless sensors into measures and~     descriptors to be automatically evaluated by a an interactive smart mirror. This Wize~     Mirror extracts descriptors from videos, images and gas concentration signals and~     integrates them in a virtual model used to compute and trace the evolution of an~     individual's wellness index. A health diary enables each individual to evaluate and~     personally relate his/her lifestyle to his/her well-being. Coaching messages are provided,~     in relation to the evolution of the wellness index and of each descriptor, to provide useful~     suggestions on correct lifestyle self-monitoring.~      The purpose of this study is assess the accuracy of the information derived from the Wize~     Mirror in expressing the health status of the individual.~      The reproducibility and repeatability study will evaluate whether measurements are stable~     over short time spans and whether they are influenced by meals light and temperature~     conditions.~      To verify whether the Wize Mirror is able to detect variations in physical and emotional~     health status with appropriate lifestyle changes, the validation study will cross-check~     measurements from the Wize Mirror against reference clinical tests at enrolment and after 3~     months of personalized suggestions for healthy behavior.~      Reference tests include~        -  Physician visit~        -  Measurement of blood oxygen content and skin end products of sugar metabolism,body~          composition, energy expenditure, vascular function~        -  Laboratory profile and exhaled gas composition~        -  Questionnaires on quality of life and lifestyle (food, sleep, physical activity,~          smoking, alcohol, stress).~      Wize Mirror measures include~        -  3D reconstruction of face images for roundness, color, stress and fatigue~        -  Heart and respiratory rate~        -  Detection of skin sugar metabolism end-products and of eye lipid deposits~        -  Small vessel vasodilating ability with local heating The results will allow to assess~          whether the Wize Mirror is easy to use and helpful for self-monitoring of~          cardio-metabolic risk.~   "
18247|NCT02818491|"~     Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene~     brachial plexus block is considered by many as the gold standard for treating postoperative~     pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus~     in the neck. Duration of analgesia is between eight to twelve hours depending on the type of~     administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in~     anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different~     trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics~     for a perineural injection may prolong the duration of analgesia up to 24 hours. In a~     meta-analysis including 29 trials and 1695 patients, investigators have recently~     demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a~     ceiling dose, without neurological complications. The objective of this multicenter~     randomised controlled double-blinded trial is to determine the optimal dose of perineural~     dexamethasone. For that purpose, investigators will include a total of 150 patients divided~     in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.~   "
18248|NCT02818478|"~     To investigate if electronic reporting of patient reported outcome measures from home is~     comparable to the traditional touch-screen solution to hospital among patients with~     rheumatoid arthritis and axial spondyloarthritis~   "
18249|NCT02818465|"~     Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high~     cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest,~     advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze~     the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and~     prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while~     accumulation of AGEs will be measured in the serum and in the skin (non invasive).~     Additionally factors influencing RAGE activation such as genetic polymorphism and level of~     soluble forms of RAGE will be measured and analyzed.~   "
18250|NCT02818452|"~     The objective of this study is to determine the effect on glycemic responses of adding~     various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the~     dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which,~     when added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at~     least 20% less than that elicited by a β-glucan-free cereal.~   "
18251|NCT02818439|"~     ARPEGE project fits within the general framework of maintaining functional autonomy in the~     frail elderly. The early identification of elderly people at risk of frailty is essential to~     be able to make corrective actions to maintain a quality of life desired by the person.~     ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that~     could be used in various environments (home, prevention center, office of the general~     practitioner, geriatric consultation), and manipulated intuitively by professionals not~     specialists.~      This four-year project spearheaded by the University of technology of Troyes in partnership~     with the University of Reims Champagne-Ardenne also brings a set of partners and experts in~     the region and outside, so that the proposed solution has the qualities necessary for its~     deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.~      The Region has made longevity aging theme one of its priorities. This image of driver of~     innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific~     and technological results expected, one can imagine the potential socio-economic benefits if~     this tracking solution is deployed on a large scale.~   "
18252|NCT02818426|"~     UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce~     strong TH1 CD4 T cell responses in cancer patients.~      Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by~     using Continuous Reassessment Method (CRML) dose escalation design model.~      The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to~     estimate its Maximum Tolerated Dose (MTD).~      The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax~     according to the dose level.~   "
18253|NCT02818413|"~     This research is being done to investigate fecal microbiome and metabolome as well as serum~     analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other~     elite athletes.~   "
18277|NCT02818101|"~     The purpose of this study is to confirm the utility for hypnosis in the coronary~     angiographic examination. The technique would be an alternative to prevent the consumption~     of anesthesic drugs.~   "
18278|NCT02818088|"~     This unique study will allow us to observe the neural correlates associated with working~     memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing~     working memory in participants suffering with OCD will reduce the severity of their~     symptomology. This will allow a greater understanding into the functioning of these~     participants which in turn presents with treatment possibilities.~   "
20350|NCT02790827|"~     This study evaluates the effectiveness of a multi-pronged intervention in reducing and~     preventing violence against women and children compared to a treatment as usual control~     group among families living in Lusaka, Zambia.~   "
18255|NCT02818387|"~     Propofol is a well-known induction agent which can provide sound and quick hypnosis with~     anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while~     using this agent. Propofol in combination with remifentanil or midazolam can result in~     synergistic or additive effect in elderly patients. There are not many studies which provide~     minimum dose of propofol to induce hypnosis in combination with these agents and advantage~     of the combination.~      The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are~     enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR).~     Sample size have been decided due to the previous studies which have mentioned 40~     participants as a adequate sample size for this biased coin design - up and down study.~      After receiving informed consent, patients will be participated in this study. No~     premedication will be given to the patients before induction. The patients in group P will~     receive general anesthesia only with propofol and group PR and PMR will receive 0.125~     mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in~     group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the~     remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose~     will be changed by the result of prior study participant.~      'Success' of this study will be defined as loss of both verbal response and eyelash reflex~     in 3 min after propofol administration. When 'success', the next patient will receive the~     same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol.~     When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at~     induction period.~   "
18256|NCT02818374|"~     The purpose of this study is to evaluate the efficiency and the safe use of a new medical~     device to improve the oral accessibility of disabled people during the oral-dental~     examination.~   "
18257|NCT02818361|"~     Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China~     for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of~     its reproductive system toxicity. The investigators are inspired by Chinese external~     therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF~     topically in order to get an effective and safe treatment for active RA patients.~   "
18258|NCT02818348|"~     This study aims to provide information about the safety and pharmacokinetic drug-drug~     interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in~     HIV-infected patients, as well as evaluate the efficacy of concomitant administration of~     darunavir/cobicistat and etravirine.~   "
18259|NCT02818335|"~     The purpose of this study is to measure how much LY3023414 (a test formulation and a~     reference formulation) gets into the blood stream and how long it takes the body to get rid~     of it.~      The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking~     LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations~     will be evaluated. Information about any side effects that may occur will be collected.~      This study includes 3 periods. Participants will be admitted to the clinical research unit~     (CRU) one day before dosing in each period. Total study duration is about 21 days, including~     follow-up. Screening may occur up to 30 days before the first dose of study drug.~      This study is for research purposes only and is not intended to treat any medical~     conditions.~   "
18260|NCT02818322|"~     The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to~     compare telemedical + standard and standard alone outpatient monitoring in the care of~     patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of~     the overall study is the time of ulcer healing. The number of amputation, hospital~     admissions and surgical procedure will be also reported. Investigators hope to include 150~     patients in this study.~   "
18261|NCT02818309|"~     Lesogaberan may be used in Chinese GERD patients with partial response to PPI.~   "
18262|NCT02818296|"~     This investigation examines the efficacy of a brief, one-session computerized interpretation~     bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty.~     Intolerance of uncertainty is a risk factor for the development and maintenance of various~     forms of psychopathology.~   "
18263|NCT02818283|"~     Combination antiretroviral therapy (ART, HIV medications) dramatically increases the~     expected lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for~     cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this~     population. This increased risk may be linked to persistent inflammation and activation of~     the immune system. Although the relationship between cardiovascular disease and HIV-infected~     individuals who are taking HIV medications is not well understood, the team of researchers~     involved in this study observed that a diet rich in soy, at levels recommended by the FDA~     (Federal Drug Administration), improved cholesterol levels and inflammation in individuals~     not infected with HIV. From this study, the researchers hope to gain understanding on how~     dietary soy will impact HIV-infected individuals who are taking HIV medications. Two~     pretzels with and without soy developed at OSU (Ohio State University) in the Department of~     Food Science and Technology and used in previous clinical trials will be used to investigate~     how the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your~     body breaks down naturally occurring chemicals from soy.~   "
18264|NCT02818270|"~     Aerosol delivery through a ventilator is influenced by numerous factors from~     ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery~     through a ventilator system was studied on bench model with albuterol, yet the results were~     often overestimated. The objective of this study was to evaluate inhaled bronchodilator and~     mucolytic agents delivered through a ventilator system.~   "
18265|NCT02818257|"~     The aim is to investigate the impact that water absorption properties in adhesives has on~     adhesion.~   "
18266|NCT02818244|"~     In 2015, over 85 million fitness wearables were sold worldwide and the market is projected~     to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices~     that track heart rate are predicted to be the most popular. At the elite level, commercial~     heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew~     Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of~     ordinary consumers purchase fitness trackers that include heart rate monitors in order to~     help them to maintain their health and wellness. As popularity of these fitness devices~     grows, assessment of the accuracy of heart rate measurements becomes increasingly important.~   "
18267|NCT02818231|"~     Nasal adenocarcinomas are closely related to wood dust exposure. The precise mechanisms of~     carcinogenesis leading to the transformation of the respiratory mucosa into a colonic-like~     mucosa remain unknown: chronic exposure to wood dust may cause chronic inflammation that may~     lead to pre-degenerative lesions, hypothesis yet unconfirmed. The tumor development requires~     the activation of a particular gene: CDX2. The working hypothesis is that chronic wood dust~     exposure is responsible for changes in genes of inflammation, which can in turn lead to~     changes in the expression of CDX2 and its cofactors, thus making possible the genesis of~     adenocarcinoma. This work is a pilot study aiming to better understand the mechanisms of~     carcinogenesis, and to study the feasibility of a larger prospective screening for~     woodworkers adenocarcinomas. Cells will be obtained from the at risk area (olfactory cleft)~     by a noninvasive method (brushing) in healthy volunteers (unexposed to wood dust) and in~     exposed volunteers to compare their genomes and study the genomic changes related to wood~     dust exposure.~   "
18268|NCT02818218|"~     Consecutive patients undergoing liver transplant surgery will be included in the study.~     Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during~     the postanhepatic phase and following closure of the deep fascial layer of the anterior~     abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP~     will be recorded.~   "
18269|NCT02818205|"~     The purpose of this study was to explore the feasibility of detecting physiological patterns~     of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD).~     Accordingly, two questions directed this methodological research investigation: (1) Is there~     a relationship between rest (tonic) and response (phasic) patterns of arousal among~     typically developing children and children with ASD?, and (2) Is there a difference in EDA~     response to sensation between typically developing children and children with ASD?~   "
18270|NCT02818192|"~     The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk~     factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they~     cause renal injury. The Study Aims include:~        1. Characterize the primary BPS risk factors associated with prevalent and progressive~          albuminuria in youth with T2D.~        2. Determine individual, family and community level factors that influence biological and~          psychological risk factors and behaviors (adherence) that could be modified to protect~          against prevalent and progressive albuminuria.~        3. Determine if systemic and renal inflammation is the common pathway through which BPS~          risk factors lead to albuminuria in youth with T2D.~      Study Hypotheses include:~        1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and~          psychological and social adversity (stress, mental distress and poverty) are~          significant predictors of prevalent and progressive albuminuria in youth with T2D.~        2. Community and family support will be negatively associated with stress, and a lower~          risk of both prevalent and progressive albuminuria.~        3. Systemic and renal inflammation is the common pathway through which BPS risk factors~          lead to albuminuria in youth with T2D.~   "
18271|NCT02818179|"~     This research aims to investigate the correlation between tumor temperature difference and~     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.~      In addition, normal tissue response to radiation therapy in treated organ will be evaluated.~   "
18272|NCT02818166|"~     The purpose of this study is to prospectively evaluate major and minor neurologic events in~     patients undergoing right mini-thoracotomy mitral valve surgery and to compare different~     aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion~     (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events~     will be evaluate through standard neurologic evaluation; minor neurologic events will be~     evaluate through magnetic resonance (MR) assessment.~      The first aim of the study is to determine the number and impact of microembolic events~     during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR~     evaluation. The investigators also aim to determine if different techniques of aortic~     clamping may impact on early outcome.~      Study hypothesis: despite recent concerns arising about endoaortic balloon with retrograde~     perfusion, the investigators expect to show equivalence in term of safety and effectiveness~     of this technique compared with the transthoracic clamp in a selected population.~   "
18273|NCT02818153|"~     Allergic rhinitis is a common condition that affects adults as well as children and~     adolescents, often with impaired quality of life. Patients often report a poor level of~     satisfaction with the effectiveness of their treatment and are always looking for more drug~     combinations to improve their symptom. Several tools exist for assessing control of allergic~     rhinitis, but none has been validated in adolescents or in children. A study conducted in~     2008, resulted in the validation of a self-administered control test of allergic rhinitsis~     (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents~     aged 12 to 17 years old and lacked power.~      In this new study,the investigators propose, following exactly the same procedure as the~     pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in~     adolescents 12 to 17 years inclusive.~   "
18274|NCT02818140|"~     Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain,~     despite a multimodal analgesic regime.~      We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will~     significantly reduce postoperative opioid consumption and pain following PNL operation~     compared with placebo (saline) TQL block.~      The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block~     concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime~     alone (and placebo TQL block) in a randomized and placebo controlled design.~   "
18275|NCT02818127|"~     The aim of this study is to evaluate and describe the total coronary circulation time (TCCT)~     by using TIMI frame count method in patients performed coronary angiography. TCCT is~     described as an angiographic index which is the sum of the frame count of coronary artery~     and venous system. This study also evaluates the relationship between the diseases in~     arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease~     and coronary venous pathologies.~   "
18276|NCT02818114|"~     The investigators plan to develop and test an intervention using peer specialists (Veterans~     who have managed PTSD and completed PE) to provide support services for Veterans using~     prolonged exposure therapy.~   "
18279|NCT02818075|"~     This pilot study will evaluate the feasibility and acceptability of a mobile phone based~     peer support intervention among adolescent mothers. Half of the participants will receive~     usual care plus the peer support intervention and the other half of the participants will~     receive usual care only.~   "
18280|NCT02818062|"~     The host-immune reaction to infection is essential for the comprehension of the disease and~     the development of new therapies.~      The aim of the study is to describe intraocular cytokines network in aqueous humor using~     multiplex immunoassay, during severe intraocular infection.~   "
18281|NCT02818049|"~     The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an~     inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse~     aggression. A European study estimated that this disease represents 7% of admissions to~     intensive care. Despite progress on the modalities of mechanical ventilation, mortality is~     always between 25 and 55%. The definition of this syndrome was recently amended by~     individualizing three sub groups based on the importance of hypoxemia (mild, moderate and~     severe). Achieving a bronchoalveolar lavage (BAL) by bronchoscopy remains a gold standard in~     the initial research of pulmonary infectious cause or secondarily face the suspicion of~     ventilator-associated pneumonia. Cardio pulmonary consequences of this act are not well~     known in patients with ARDS. The first studies on the consequences of a bronchoscopy on~     oxygenation of a patient breathing spontaneously have 40 years. More recent work showed a~     simple bronchoscopy could in the mechanically ventilated patient cause an average decrease~     of 26% from the base of PaO2, 10% of the mean arterial pressure (MAP) and a significant~     increase in cardiac output. The existence of ARDS was an independent risk factor associated~     with hypoxemia. A study by published in Crit Care Med in 1990 can serve as a reference in~     ventilated patients benefiting from BAL by bronchoscopy: in a subgroup of 26 patients, 23%~     of patients required an increase in the fraction of inspired oxygen (FiO2) post procedure. A~     study compared changes in PaO2/FiO2 after BAL with and without endoscopy among patients~     without (n = 23) or with pneumonia (n = 11): the decrease in PaO2/FiO2 was significant only~     in the pneumonia group. In a study of 30 patients ventilated but not hypoxic , PaO2 was~     still reduced by 20% 2 hours after the completion of a BAL in 40% of patients. A~     retrospective series of 99 ventilated patients but not hypoxic, shows that the BAL was well~     tolerated in accordance with a pre oxygenation procedure 15 min and by gradually decreasing~     the FiO 2 after the end of the procedure. BAL also appears well tolerated in a study of 12~     patients ventilated under sedation and muscle relaxation, in shock and in need of positive~     expiratory pressure (PEEP) of at least 10 cm H2O but the authors show a decrease in PaO2~     that extends well beyond the end of the intervention. Their conclusion is going to offer~     less invasive diagnostic techniques for patients with PaO2 less than 60 mm. No study has~     targeted the respiratory and hemodynamic consequences of this technique depending on the~     intensity of ARDS (mild, moderate or severe).~   "
18282|NCT02818036|"~     The purpose of the study is to explore the effect of blocking opioids on affiliation-related~     neural activity.~   "
18283|NCT02818023|"~     The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis~     would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional~     as a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be~     dampened by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T~     cells in the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy.~     Progression free survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and~     46.4% in the more recently reported phase III trial. PFS with vemurafenib treatment in~     BRIM-3 was ~50% at 6 months. Combined treatment with pembrolizumab and vemurafenib for BRAF~     mutant melanoma is hypothesized to be safe and to improve the PFS compared to these recent~     historical controls. Because this combination has not yet been tested, and because the~     primary objective is to assess safety, the investigators are staging accrual in the first~     phase of the trial. The study aims to accrue up to 50 patients to the mTPI design of this~     study with the expectation that there will be at least 30 patients treated at RP2D. In case~     there are less than 30 patients on the RP2D, additional patients will be accrued. Patients~     will continue to receive treatment with pembrolizumab and vemurafenib until disease~     progression or toxicity. Patients with treatment response and no dose limiting toxicity may~     receive treatment with pembrolizumab for up to 24 months.~   "
18284|NCT02818010|"~     PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups:~     patients exposed to physical activity and unexposed. The main objective of the study is to~     compare the evolution of glomerular filtration rate at inclusion and 12 months later between~     patients practicing physical activity and patients not practicing. If necessary, the renal~     disease-related complications, which are not influenced by physical activity: (type of~     kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic~     kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum~     creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are~     followed in the trial during 12 months. To evaluate physical activity, patients respond to~     Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During~     this 12 months period, the same biological data are collected prospectively.~   "
18285|NCT02817997|"~     The purpose of this study is to collect clinical, laboratory, and patient survey data from~     patients with Castleman disease to improve understanding, diagnosis, and treatment of the~     disease.~   "
18286|NCT02817984|"~     The purpose of this study is to assess the safety and tolerability of acellular adipose~     tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy~     volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon~     injection into human soft tissue.~   "
18287|NCT02817971|"~     A cluster randomised pragmatic trial will be conducted within an emerging clinical~     information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to~     an enhanced feedback intervention delivered over a nine-month period and compared to~     standard feedback. The trial to be implemented during a phase of implementing change in~     guideline recommendations for pneumonia will assess the impact of enhanced feedback on~     hospital uptake of the revised pneumonia treatment recommendations.~   "
18299|NCT02817815|"~     Arterial thromboembolism constitutes a major risk of atrial fibrillation (AF) requiring~     antithrombotic therapy. Platelets and microparticles (MPs) are important for hemostasis and~     thrombosis, their role during AF is not well known. The principal objective of this study is~     to compare morphologic, functional and proteomics characteristics of blood platelet between~     AF patients and healthy volunteers.~   "
18300|NCT02817802|"~     The registry will investigate the clinical performance and long-term safety of Magmaris in a~     real world setting~   "
18301|NCT02817789|"~     Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic~     stenosis in old and frail patients. Antiplatelet therapy must be associated for the~     procedure and during few weeks after implantation in the aim to minimize cerebral~     embolization. But for now, the best antiplatelet regimen has to be determined. In this~     context, investigators want to evaluate the safety of use of ticagrelor alone versus~     standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study,~     we will randomly compare 154 patients in each group in terms of early safety (30 days) after~     the procedure.~   "
18288|NCT02817958|"~     Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival~     are influenced by metastatic lymph node involvement. Its frequency in France is estimated at~     less than 1% of human cancers. This spread follows a sequential process via the superficial~     and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic~     dissemination.~      The management of inguinal areas is the cornerstone of penile cancer. It is curative in~     about 80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on~     average 85% for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall~     survival was 70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to~     10% for pN3.~      The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by~     lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months.~     Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication~     depends on clinical examination (presence or absence of lymph nodes palpated) and the risk~     of nodal disease (≥ pT1bG2).~      Currently, a fine needle biopsy is the best clinical diagnosis method because it is a~     simple, low risk and possible in consultation. When the result is positive, it allows an~     early dissection. Single or double fine needle biopsy will be used in cN + patients. For~     patients at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node~     diagnosis may be followed by modified or bilateral lymphadenectomy.~      Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in~     patients with metastatic lymph node involvement. Therefore it seems important to develop a~     multimodal approach in the management of these patients in order to increase the response~     rate to treatment and survival.~      From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide~     and cisplatin) appears to have an efficacy / toxicity acceptable.~      The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant~     treatment in patients with high risk of lymph nodes involvement (cN0 and ≥ pT1B or G2), and~     with inguinal mobile palpated lymph nodes (cN +) respectively, after lymph nodes involvement~     proven (pN +).~   "
18289|NCT02817945|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in~     lung cancer patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3PTATE-RGD~     will be injected intravenously. Visual and semiquantitative method will be used to assess~     the PET/CT images.~   "
18290|NCT02817932|"~     The purpose of this study is:~      To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and~     Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg~     after single and repeated oral administrations.~   "
18291|NCT02817919|"~     This cohort event monitoring will document real-life safety experiences following the intake~     of Injectable AS. Specifically, the study will record common adverse events that are~     associated with the use of Inj. AS and associating factors such as age and gender that make~     some of these events more likely. The sample size of 3000 patients will enable the~     documentation of causally-related events that occur at frequencies of 1 in 1000 or more.~     Since quinine, the previous gold standard for treating severe malaria may still be used by~     facilities in addition to artesunate and artemether, the study will concurrently monitor the~     safety of these products though focus of the study is the capture of adverse events~     following exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will~     also enable treatment practices in the study areas to be documented.~   "
18292|NCT02817906|"~     This is a randomized, double-blind, placebo-controlled study comparing the efficacy and~     safety of ITI-007 versus placebo administered orally once daily in the treatment of~     agitation in patients with dementia, including Alzheimer's disease.~   "
18293|NCT02817893|"~     The waveform plethysmographic signal can be used to establish an index for predicting fluid~     responsiveness (∆POP: respiratory variation of the plethysmographic waveform of pulse~     oximetry). This index was validated in some studies and because of its non-invasiveness it~     seems very interesting in anesthesia.~      However, in a previous study the investigators evaluated the correlation between the results~     provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure~     variation), and the obtained results were significantly lower than what had been previously~     described. In this study, the index was calculated from a recording of a filtered signal.~     This unavoidable application of a filter on anesthesia monitors could contribute to the~     discrepancy between the ∆POP and the ∆PP.~      The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered~     plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.~   "
18294|NCT02817880|"~     The purpose of this study is to compare the analgesic effectiveness of two motor cortex~     neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the~     algoneurodystrophy.~   "
18295|NCT02817867|"~     Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and~     morbidity in the Brazilian population, and is considered a major cause of disability in~     adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and~     modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric~     inhibition. This condition affects patient's functional recovery.~      The aim of this study is to verify the effectiveness of repetitive transcranial magnetic~     stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct~     Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between~     these two types of brain stimulations on the upper limb recovery after stroke.~   "
18296|NCT02817854|"~     Diverticular disease is a common disease in developed countries, affecting 2.5 million~     individuals in the United States (US). Prevalence of diverticula increases with age and goes~     up to 50 to 66% in patients older than age 80 years. Approximately 10 to 25% of patients~     with diverticulosis will develop diverticulitis. Acute diverticulitis (AD) accounts for~     312,000 admissions and 1.5 million days of inpatient care in the US, where its annual~     treatment costs exceed 2.6 billion dollars. With the ageing of global population these~     numbers are expected to rise.~      Procalcitonin (PCT) is a biomarker widely used to monitor bacterial infections and guide~     antibiotic therapy in Intensive Care Units and has been shown to be useful in different~     surgical fields such as acute appendicitis. Recently, has been demonstrated that PCT and CPR~     have good predictive value of anastomotic leak (AL) after colorectal surgery.~      A multicentric study has been designed to test if PCT, CRP and WBC values might be able to~     predict the outcomes of patients admitted in emergency setting for acute diverticulitis. In~     particular if they might distinguish between patients needing only conservative (nothing per~     os, iv fluids and antibiotics) or interventional therapy such as radiological drain or even~     surgery, in the aim to optimize and individualize each patients therapy and speed patients~     discharge.~   "
18297|NCT02817841|"~     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding~     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol~     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.~   "
18298|NCT02817828|"~     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding~     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol~     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years.~   "
18305|NCT02817737|"~     Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of~     the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.~      Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy~     participants using computed tomography (CT). The CTA, angle between clinical~     transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed~     between the mechanical axis of the tibia and tibia plateau line. The correlation between the~     CTA and the PTA was analyzed statistically with the linear regression.~   "
18306|NCT02817724|"~     The purpose of this study is to determine if it is better an integral strategy, with a~     m-health system, when used in addition to a supervised treatment, versus the use of the~     m-health system alone, to improve the immediate and long-term Quality of Life of breast~     cancer survivors.~   "
18307|NCT02817711|"~     The prospective Cohort includes all patients with bone or joint infection (BJI), with or~     without implant. The aim of this Cohort is to improve the knowledges about the treatment~     failure and the occurrence of serious adverse events. Various data of patients included are~     collected and will be analysed.~      Patients with a bone or joint infection are treated at the department of infectious~     diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a~     consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months~     after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery.~     It allows to the physician to follow the evolution of the patient under treatment and after~     discontinuation of the treatment.~      Several data are collected during the follow-up concerning: demographics data, treatment~     including the use of off-label antibiotics for the treatment of BJI, adverse events,~     microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If~     there is an implant, the date of implantation and the number of the prosthesis infected are~     collected.~      This cohort allows to improve knowledge concerning the treatment failure and the occurrence~     of adverse events.~   "
18308|NCT02817698|"~     The investigators' project has two overarching goals. 1) The investigators will use newly~     developed positron emission tomography (PET) technology to investigate the dopaminergic~     neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine,~     and 2) The investigators will extend PET technology to an additional neurotransmitter system~     - namely, the opioid-ergic system, using the same drugs of abuse.~   "
18309|NCT02817685|"~     This study is a randomized control prospective study. The aim of this study is to establish~     an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection~     and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different~     surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B~     and cirrhotic patients with different risk of HCC.~   "
18310|NCT02817672|"~     The goal of this project is to conduct a pilot study to test the utility of a Natural~     Language Processing (NLP) clinical messaging tool to improve the reach and the quality~     (fidelity and competency) of coaches providing behavioral activation (BA) strategies through~     a mobile mental health app called Personalized Real-time Intervention for Motivational~     Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered~     messaging tool, which will ensure fidelity to the BA model and clinicians will have access~     to real-time clinical information about their patients to guide more targeted treatment~     (competence). If successful, PRIME could operate as a cost effective tool for clinicians to~     extend their reach and an accessible treatment for the population of those struggling with~     depression.~   "
18311|NCT02817659|"~     To further understand the tolerability of glucagon.~   "
18312|NCT02817646|"~     The purpose of this study is to determine whether protein intake during the first days of~     intensive care admission, in relation to body composition at intensive care admission as~     assessed on computed tomography scans made during routine care, is are related to clinical~     outcome in critically ill patients.~   "
18313|NCT02817633|"~     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T~     cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and~     in combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have~     limited available treatment options. The study will be conducted in 2 parts: dose escalation~     and cohort expansion.~   "
18314|NCT02817620|"~     The purpose of this pilot study is to assess the beneficial effect of a spirulina water~     extract (product named Spirulysat®) compared to a placebo in the blood level ratio of~     oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of~     consumption~   "
18315|NCT02817607|"~     The purpose of this study is to establish techniques for evaluating breast cutaneous~     sensation at baseline and following either lumpectomy or mastectomy for breast cancer.~   "
18316|NCT02817594|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in the Netherlands in a~     clinical practice patient population.~   "
18317|NCT02817581|"~     To validate the NEWS and rapid lactate testing for early identification of high risk [triage~     Category 3 (urgent)] patients in the Emergency Department.~      To compare qSOFA and SIRS criteria in patients in the Emergency Department.~   "
18318|NCT02817568|"~     The aim of this study is to estimate genetic impact of MCP-1 -2518 and its receptor CCR2~     -190 polymorphisms on AgP patients among Turkish individuals and whether MCP-1 genotype~     effects mRNA levels of Peripheral Blood Mononuclear Cell Leukocyte (PBML)~   "
18319|NCT02817555|"~     The purpose of this study is to determine if there is a cost difference between darbepoetin~     alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.~   "
18356|NCT02817074|"~     Phase III randomized controlled trial designed to test the effects of a 3-year intervention~     of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive~     decline and brain neurodegeneration among 600 individuals 65+ years without cognitive~     impairment who are overweight and have suboptimal diets.~   "
18320|NCT02817542|"~     Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on~     admission have high rates of mortality (1). The management of hyperglycemic patients during~     STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary~     percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic~     patients (2).~      Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI~     undergoing quantitative coronary angiography were studied. Patients were categorized in two~     groups, either treated by thrombus aspiration v/s patients treated without thrombus~     aspiration. After discharge from the hospital, all patients will be managed and followed~     quarterly for 12 months month after event, as outpatients, to perform clinical evaluation,~     routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in~     both cohorts will include cardiac mortality, all-cause mortality and hospitalization for~     coronary disease and heart failure.~      Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA~     before PCI, as compared to hyperglycemic patients treated only by PCI.~   "
18321|NCT02817529|"~     Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion~     mobilization, also prevent the small airway from collapsing. The purpose of this research is~     to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients'~     compliance, satisfaction, 3 months and 6 months lung function test and life quality will be~     compared.~   "
18322|NCT02817516|"~     The purpose of this study is to evaluate the safety and tolerability of multiple oral doses~     of TAK-828 in healthy participants.~   "
18323|NCT02817503|"~     The purpose of the current feasibility study is to test whether the blood pressure level of~     the study patients can be effectively and safely managed according to the intensive~     antihypertensive treatment protocol. Furthermore, the study will also examine the effect of~     intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes,~     including CIMT, carotid plaques, PWV ABI, and kidney function, etc.~   "
18324|NCT02817490|"~     The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically~     heterogeneous, inherited connective tissue diseases. The hypermobility type is the most~     frequent. It is characterized by a generalized joint hypermobility and a hyperextension~     skin.~      Chronic pain syndrome is often present. Its psychological impact can be significant~     (anxiety, depression, impact on the quality of life of the patients). The disease also~     requires changes and a permanent adaptability (coping). It can lead to feelings of isolation~     and misunderstanding.~      The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the~     'Croix-Rouge Française des Massues' propose a patient education program for the patients~     with a hypermobility type SED (the PrEduSED program). This education program is open to~     patients and their caregivers located in France.~      The research hypothesis is that the PrEduSED program improves their coping and reduces~     patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could~     have the most impact, given the results of the first sessions).~   "
18325|NCT02817477|"~     Introduction: Ketamine has been well studied for its efficacy as an analgesic agent.~     However, intranasal (IN) administration of ketamine has only recently been studied in the~     emergency setting.~      Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN~     Ketamine compared to IV and IM morphine.~      Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and~     safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency~     department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe~     acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive~     either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse~     effects were recorded for 1 hour post-administration.~      Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO,~     measured by time-to-onset (defined as a ≥15mm pain decrease on VAS), as well as time to~     and degree of maximal pain reduction.~   "
18326|NCT02817464|"~     The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of~     TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive~     effect when injected every 6 months.~   "
18327|NCT02817451|"~     Study is to assess and confirm the adequate immunogenicity and safety profile of the Sanofi~     Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in~     HIV-exposed uninfected infants (HIV-exposed uninfected) and in HIV-exposed infected infants~     (HIV-exposed infected).~      Primary Objectives:~        -  To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary~          series in HIV-exposed infected and in HIV-exposed uninfected infants.~        -  To describe the persistence of all antibodies before receipt of the booster vaccination~          in HIV-exposed infected and in HIV-exposed uninfected infants.~        -  To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in~          HIV-exposed infected and in HIV-exposed uninfected infants.~      Secondary Objectives~        -  To describe the safety profile after each and all doses of the study vaccine~          administered as a 3-dose infant primary series in HIV-exposed infected and in~          HIV-exposed uninfected infants.~        -  To describe the safety profile of the study vaccine administered as a booster in~          HIV-exposed infected and in HIV-exposed uninfected infants.~   "
18328|NCT02817438|"~     This study examines how online self-guided programs can improve mood and anxiety symptoms.~     These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based~     treatment for depression and anxiety. The purpose of this study is to learn who will do best~     with the online format. Our aim is to learn for whom online self-guided interventions are~     most efficacious. This knowledge is important because it will help inform clinicians and~     patients about who might benefit from this type of intervention versus who would need the~     assistance of a therapist. More specifically, we hope to figure out who would benefit from~     solely an online intervention and who would benefit from an online intervention in addition~     to other treatment.~   "
18329|NCT02817425|"~     This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or~     SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric~     cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.~   "
18330|NCT02817412|"~     This study will examine the effectiveness of food response training interventions in~     reducing binge eating among adults engaged in binge eating.~   "
18334|NCT02817360|"~     Purpose and rationale The purpose of this study is to evaluate the effect of high dose~     Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary~     prevention of cardiac events in a population of patients with Type 2 diabetes mellitus~     (T2DM) with no evidence of a preexisting cardiac disease. An additional aim is to~     demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic~     peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the~     economic impact of the intervention overall and in the biomarker stratified subgroups.~      Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers~     compared to conventional therapy regarding the reduction of unplanned hospitalization or~     death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml.~      There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study~     is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early~     subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the~     evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset~     and progression of diabetic retinopathy.~   "
18335|NCT02817347|"~     In patients with otitis media presenting with otoscopy-confirmed otorrhea who had~     tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability,~     and the proportion of patients with cessation of otorrhea after ear-drop administration of~     YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.~   "
18336|NCT02817334|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to~          ensure better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
18337|NCT02817321|"~     This prospective, randomized study,control study aims to compare the analgesic~     effect,opioids consumption,quality of recovery,length of hospital stay and incidence of~     chronic pain,et al. between single-injection TPVB(thoracic paravertebral block) ,~     single-injection TPVB +continuous TPVB and intravenous patient-controlled analgesia (IPCA)~     alone in patients undergoing hepatectomy with right J-shape subcostal incision.~   "
18338|NCT02817308|"~     Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in~     the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important~     components in decision making and follow-up of patients diagnosed with this disease.~      These tumor markers were found to be elevated not only in the serum but also in other body~     fluids in patients with malignant lesions of the parotid gland and the urinary tract. The~     authors have described in a previews small preliminary study a positive and a strong linear~     correlation between the levels of CA19-9 in urine and saliva with those presented in the~     serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to~     enlarge the study population to confirm the previous results and standardize the measured~     levels of CA19-9 in these body fluids.~   "
18339|NCT02817295|"~     an examination of the different aspects of bariatric surgery in elderly in comparison with~     non-elderly patients.~   "
18340|NCT02817282|"~     Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent~     healthcare-associated infections (HAIs), implementation in daily routine is difficult. The~     residential setting and specific population pose challenges to optimal HH compliance. This~     study aims to develop and to evaluate an evidence based multi-component implementation~     strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH~     compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and~     facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting.~     The strategy will be tested in a stepped wedge cluster randomized design which is based on a~     random sequential roll-out of the implementation strategy to all participating NHs (n=20)~     for comparison. Data are collected during six consecutive four month periods with an initial~     baseline period for all NHs.~      During each period 1200 opportunities for HH are observed, using the gold standard of direct~     and unobtrusive observations, according to the Five Moments for HH of the World Health~     Organization. HAIs incidence densities, collected in the sentinel surveillance network for~     infectious diseases in nursing homes (SNIV), will be evaluated in parallel.~      A multi component implementation strategy, combining activities aimed at individual HCWs,~     teams and the organization will be used. The individual level includes education, skills,~     action planning, reminders and feedback. The team level includes activities that focus on~     social influence, strengthening of leadership by gaining active commitment and initiative of~     ward management. The organizational level addresses the structural context and institutional~     management support.~      To assess the cost implications of the CHANGE strategy, an economic evaluation will be~     conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here~     as the costs for the CHANGE strategy minus less costs for treating infections, divided by~     the difference between HAIs before and after the intervention period, will be calculated. A~     process evaluation will be performed during and after the intervention to investigate the~     feasibility of the implementation strategy and to illuminate the mechanisms and processes~     responsible for the results and their variation within the NHs.~   "
18341|NCT02817269|"~     The first aim of the study will be to identify the most common ReP pattern and compare its~     coincidence with that described by Travell and Simons. Second, the study aim will be to~     verify whether there are any significant differences by sex and types of technique used in~     regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more~     sensitive.Finally, the third aim of the study will be to determine whether deep dry needling~     will evoke the LTR and ReP more easily than manual palpation.~   "
18357|NCT02817061|"~     Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light~     exposure to the head, can improve frontal lobe executive function, working memory and~     overall mood in normal volunteer participants.~      Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as~     measured by Cambridge Cognition cognitive testing in study subjects.~   "
18358|NCT02817048|"~     Chest tube placement after thoracoscopy surgery had been generally accepted as routine~     procedure for removal of the residual intrapleural fluid and air, however, it would cause~     post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay.~     According to the recent studies, omission of chest tube placement after minor thoracoscopic~     procedures (such as pulmonary wedge resection) had been safe and feasible, and it also~     reduced the post-operative pain and shortened the hospital stay. We will conduct a~     prospective randomized trial in National Taiwan University Hospital.~   "
18359|NCT02817035|"~     To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The~     present study was undertaken to examined the physiological signals of patients and healthy~     subjects during spontaneous breathing and noninvasive mechanical ventilation.~   "
18342|NCT02817256|"~     Bariatric surgery is emerging as an essential treatment option for the management of obesity~     and its associated comorbidities. Many patients present for surgery have pre-existing low~     blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying~     extents, and may present potential threat of micronutrient deficiencies. Therefore, long~     term nutritional monitoring and follow-ups are vital components of all bariatric surgical~     patients. However, there are no current standard practices in United Arab Emirates (UAE) for~     the biochemical monitoring and replacement of essential micronutrients in patients~     undergoing bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical~     practice guidelines recommend nutritional care however, the dose and route of administration~     supplementation after surgery based on randomized controlled trials is not yet established.~     Till tow no scientific study has been performed on monitoring vitamins and minerals levels~     following bariatric surgery among UAE population. Therefore, present study is aimed to~     determine the dose and route of administration of vitamins and minerals in improving the~     micronutrient deficiencies post-operatively. Two standard different dosage forms (oral~     /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve~     gastrectomy at Tawam Hospital. The dosages of the supplementations are within the~     international recommendations and patients will be followed up closely for a period of one~     year. The effect of nutritional deficiencies on micronutrient level and quality of life~     (QOL) will be assessed. This will help the medical practitioners to prove the optimal~     possible nutrition for patients.~   "
18343|NCT02817243|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.~   "
18344|NCT02817230|"~     In this study, the investigators will determine whether patients with elevated levels of LDL~     are characterized by specific epigenetic changes in circulating cells of the innate immune~     system, compared to control subjects with healthy levels of LDL and whether regular statin~     treatment influences these changes.~   "
18345|NCT02817217|"~     The purpose of the study is to investigate the potential PK interaction between SP2086 and~     Valsartan after multiple oral doses treatment in healthy male volunteers.~   "
18346|NCT02817204|"~     The purpose of this study is to determine the effect of aerobic exercise training on~     microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1.~     Hypertension is one of the most common world-wide chronic diseases, and it is showing a~     growing younger trend, which with mild blood pressure elevated would not be diagnose in time~     until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood~     pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However,~     cumulative evidences prove that microvascular rarefaction exist in hypertensive patients~     with even primary hypertension stage 1. Exercise prescription is gathering great importance~     in preventive health. Aerobic exercise, especially, has the potential to diminish blood~     pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease.~     Notch signaling plays an important role in vascular formation and maintenance. However,~     there is no prospective, randomized, controlled, clinic trial to investigate the effect of~     exercise on microcirculation rarefaction in hypertension. In summary, investigators propose~     a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but~     also improve microcirculation rarefaction in Chinese male adults with primary mild~     hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary~     exercise test (CPET) and then randomized in aerobic exercise intervention group and control~     group (only health education), the intervention will be carried out by Cycle Ergometer, the~     protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at~     75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal)~     and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold~     capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography~     will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood~     flow and reactive hyperemia by venous occlusion plethysmography (FMD), PWV, central arterial~     pressure, RHI with Endopat, also the quantification of endothelial progenistor cells(EPCs)~     separated from peripheral blood.~   "
18347|NCT02817191|"~     The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on~     ocular surface and tear inflammatory mediators in patients after Phaco+IOL.~   "
18348|NCT02817178|"~     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human~     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study~     tumor-specific CD4+ T cell responses.~      The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long~     term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil~     -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and~     unpublished data).~      Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post~     chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in~     metastatic colorectal cancer patients and their correlation with progression-free survival.~   "
18349|NCT02817165|"~     In North America, one of the most common reasons for hospitalization in previously healthy~     children is for the treatment of infections with antibiotics. This study will determine if,~     in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the~     co-administration of a probiotic milk product containing good bacteria, is safe and~     effective for reducing AAD, as compared to a placebo (identical appearing milk product).~     This will be a two-center, randomized, masked, placebo-controlled clinical trial. The~     results of this study will help inform clinicians and families on the use of probiotics in~     the prevention of AAD, a common side effect of antibiotic use among hospitalized children.~   "
18350|NCT02817152|"~     The aim of this study was to investigate the local effect of adjunct low-level laser therapy~     (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic~     patients.~   "
18351|NCT02817139|"~     This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare~     the effects of transcranial direct current stimulation in Chronic Migraine.~   "
18352|NCT02817126|"~     The purpose of this study is to evaluate the safety and oncological feasibility of~     robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.~   "
18353|NCT02817113|"~     NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle~     provides sustained release of the active moiety and utilizes the enhanced permeability and~     retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to~     establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and~     cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell~     carcinoma of the head and neck for further clinical study development.~   "
18354|NCT02817100|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled,~     randomized, single center design. In addition the influence of itraconazole and food on the~     pharmacokinetics of BAY1817080 will be investigated.~   "
18360|NCT02817022|"~     Enrolled neonates will be provided routine supportive care as per existing neonatal~     intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180~     days) of study commencement. This group will serve as control group (group A). During~     subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the~     inclusion criteria will be provided routine supportive care and the components of~     developmentally supportive care (DSC).~   "
18361|NCT02817009|"~     Childhood obesity is a contributing factor to health complications such as diabetes, heart~     disease, high blood pressure, cancer and asthma. It is of particular concern among Hispanic~     populations in the United States as that group has the fastest growing childhood obesity~     rate. Nearly two in five Hispanic children ages 2 to 19 are overweight or obese. This~     program aims to test whether it is beneficial to routinize a multi-disciplinary pediatric~     weight management program within the highest volume clinic (NYU-LFHC Women, Adolescents and~     Children), and to add a home-visit component to reinforce teaching on food selection and~     preparation. The intervention will include 27-hour intervention session which will be~     distributed into 12-session series over a 3 month period. The program will target Hispanic~     children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th~     percentiles. To assess the effectiveness of this program, the investigators propose to~     conduct a general prospective study using randomized pre-test and post-test control group~     design with minimal risk for participants.~   "
18362|NCT02816996|"~     The goal of this study is to find the effect of holding a patient's hand on anxiety and pain~     during dermatologic procedures.~   "
18363|NCT02816983|"~     Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA)~     are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions.~     Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as~     definitive treatment. Blood draws will be taken to monitor the development of anti-prostate~     cancer immunity~   "
18364|NCT02816970|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus~     50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition~   "
18365|NCT02816957|"~     Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa~     in children with beta thalassemia major.~   "
18366|NCT02816944|"~     The purpose of this study is to evaluate the safety and efficacy of endoscopic~     ultrasonography (EUS) guided laser ablation liver, pancreas, and retroperitoneal tumors, the~     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and~     laboratory tests including the tumor markers to evaluate the general condition of patients.~     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.~   "
18367|NCT02816931|"~     Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the~     need of improved treatment strategies. In order to protect the few available drugs that are~     left, ensuring adequate plasma concentrations of the drugs are important. Individualized~     therapy using plasma drug concentrations and minimal inhibitory concentration (MIC)~     determination may be of importance (1). The plasma drug concentrations and the MICs of the~     second-line drugs will be compared, aiming at increasing the knowledge about~     pharmacokinetic/pharmacodynamic (PK/PD) indices in the treatment of MDR-TB. In the future,~     the aim is an individualised therapy, where sub-therapeutic drug concentrations can be~     adjusted by the use of therapeutic drug monitoring (TDM). TDM in the treatment of MDR-TB may~     improve clinical outcome for the patients, but plasma concentrations must be assessed~     together with clinical and microbiological factors (2).~      In this observational study the hypothesis is that the ratio between drug concentrations and~     MICs of the anti-tuberculous drugs, are correlated to the time to sputum culture conversion,~     the bacterial load measured as time to positive liquid culture (TTP) and clinical outcome.~     Consenting adult patients with pulmonary MDR-TB patients in China will be recruited.~     MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and~     drug concentration will be determined at 2, 4 and 8 weeks after treatment initiation using~     liquid chromatography tandem mass spectrometry (LC-MS/MS), simultaneously assessing Dried~     Blood Spot (DBS) as a bio-sampling method. Sputum cultures will be obtained regularly~     throughout the treatment to measure the time to culture positivity (TTP). Clinical follow up~     according to WHO criteria will be performed at the end of treatment completion.~   "
18368|NCT02816918|"~     intends to evaluate the feasibility and security issues of univent bronchial blockers~     outside the single lumen endotracheal tube for one- lung ventilation in left thoracic~     surgery patients.~   "
18369|NCT02816905|"~     This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the~     IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to~     compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the~     children under 13 years of age who underwent bilateral strabismus surgery.~   "
18370|NCT02816892|"~     This study aims to investigate Serum Tenascin C levels in patients with acute symptoms~     relating to a known or newly diagnosed aortic aneurysm in emergency department and reveals~     the possible role of Tenascin C in the development of the disease.~   "
18371|NCT02816879|"~     This clinical trial compares three anal cytology collection procedures (collected at a~     single visit) in men who have sex with men (MSM). It also compares two different tests for~     human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to~     occur before anal cancer. This study may help doctors develop better screening for~     high-grade anal dysplasia in MSM in order to identify those who need to return for~     additional screening and treatment.~   "
18372|NCT02816866|"~     The main purpose of this study is to research the comparative effectiveness of two potential~     models of health care to deliver preventive services and chronic care management to the~     growing population of adult and pediatric survivors of childhood cancer. The central~     hypothesis is that survivorship care delivered by a subject's primary care doctor after the~     subject is empowered with individualized follow-up recommendations prepared by a cancer~     survivor specialist is similar to care provided in a specialty survival clinic.~   "
18373|NCT02816853|"~     The purpose of this study is to assess the effects of domperidone on the QTc interval~     duration in Chinese healthy adult participants after multiple domperidone doses of 10~     milligram (mg) 3 times a day (tid) and 20 mg tid.~   "
18374|NCT02816840|"~     The trial is to explore new and effective techniques in the treatment of prostate cancer and~     evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation~     therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate~     cancer will be examined with PET / CT or CT in three months after radiotherapy.~   "
18375|NCT02816827|"~     The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental~     alertness as compared to placebo.~   "
18376|NCT02816814|"~     Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most~     common menopausal disorders and chronic diseases to which women are more exposed during this~     life stage. Therefore, menopausal women may represent a target for evaluating the~     effectiveness of nutritional intervention studies based on protective diets against the~     common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis.~      Lipidomics aims to study the lipid molecules in a dynamic way and allows to define not~     only structure and functions of a set of lipid species present in an organism, but also the~     changes that occur during cell metabolism under physiological and pathological conditions in~     order to understand their role as part of the complex functional balance of a living~     organism.~      Quantitative and qualitative determination of fatty acids profiles in cell membranes allows~     to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes,~     such as inflammation, stress, nutrition.~      Scientific evidence has shown that, for nutritional studies, the most representative cell is~     the erythrocyte, which is a biomarker of an individual's general state of health. In fact,~     the evaluation of the fatty acid composition contained in the membrane of red blood cell,~     which has an half-life of four months, allows to follow the nutritional status of a subject~     and to acquire information about his eating habits, with special reference to fat~     consumption.~      The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state~     which is often altered in patients with metabolic diseases, hepatic steatosis and obesity.~      Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years,~     will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical~     examination with blood pressure and anthropometric measurements (weight, height, waist and~     hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be~     randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in~     omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled~     will undergo medical examination and dietary control to assess the adherence to the dietary~     pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry~     after 4 and 16 weeks as well as blood samples after 16 weeks.~      The results will be analyzed using appropriate statistical tests. All patients will be made~     to sign an informed consent.~   "
18377|NCT02816801|"~     In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is~     tested. Participants (n= 60) will be randomly assigned to two different groups (intervention~     vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-,~     post (6 weeks) and follow-up (3 months).~   "
18378|NCT02816788|"~     In partnership with SARI Therapeutic Riding (SARI TR), Brescia University College, at the~     University of Western Ontario, will study the use of Equine Assisted Therapy (EAT) for~     military veterans diagnosed with Post-Traumatic Stress Disorder. Data will be collected~     through tests and questionnaires, and follow-up interviews with participants. It is expected~     that after a series of 10 EAT sessions, the social, emotional and psychological well-being~     of participants will be improved and PTSD symptoms alleviated.~   "
18379|NCT02816775|"~     The intubation response to airway manipulation during direct laryngoscopy can cause~     hypertension, dysrhythmias and increased intracranial and intraocular pressures. This~     intense physiological response is proven to be associated with adverse outcomes especially~     in elderly patients. Increased QT dispersion is associated with increased risk of~     ventricular arrhythmias, which may increase the risk of sudden death caused by~     life-threatening arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic~     response than the conventional method of direct laryngoscopy. The objective of this study~     was to compare the hemodynamic response and QT during following tracheal intubation, using~     videolaryngoscope or direct laryngoscope to intubation. The postoperative airway morbidities~     is the investigators secondary outcome.~   "
18380|NCT02816762|"~     Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to~     conventional drug treatment on the albuminuria in patients with diabetic nephropathy and~     obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP~     treatment on the estimated glomerular filtration rate of patients with diabetic nephropathy~     and OSA; determine the additional longterm CPAP effect on glycemic control, insulin~     resistance, lipid profile, health-related quality of life and biomarkers of cardiac~     function, inflammation, oxidative stress, sympathetic tone and appetite-regulating hormones~     in patients with diabetic nephropathy and OSA; and to identify the subgroup of patients with~     diabetic nephropathy and OSA in which 12 months of treatment with CPAP achieve a more~     pronounced reduction in albuminuria.~      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional~     treatment-controlled trial of 12 months of duration.~      Subjects will randomize to conventional dietary and pharmacological treatment or~     conventional dietary and pharmacological treatment plus continuous positive airway pressure~     (CPAP). Study subjects: Subjects 18 to 80 years with overweight or obesity and a clinical~     diagnosis of diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and~     an estimated glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses~     of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs)~     or anti-aldosterone drugs in the last four weeks. Efficacy variables:~      urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated~     hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and~     QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin~     I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers~     (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane],~     endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y]~     and appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires:~     short form (SF)-12, EuroQoL and iPAQ.~   "
18381|NCT02816749|"~     This is a prospective study of participants with diabetic foot ulcers who will receive~     either maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound~     healing time is the main outcome measure to compare the clinical efficacy of these two~     therapies. The investigators developed a hypothesis that MDT could achieve remarkable~     shorter time and better healing rate for wound closure when compared with CDT.~   "
18382|NCT02816736|"~     The primary objective of the study is to determine whether, in patients with symptomatic,~     advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696~     for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect~     hemodynamic and clinical status, compared to treatment with valsartan.~   "
18383|NCT02816723|"~     Evidence shows the positive effects of Brain Health & Wellness classes in younger~     individuals. The proposed study investigates the usefulness of these classes in older~     Veterans aged 50-85. We hope to show that such classes can lead to improvements in both~     thinking skills as well as stress levels.~   "
18384|NCT02816710|"~     To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment~     of vitreous hemorrhage (VH).~   "
18385|NCT02816697|"~     The proposed study plans to adapt and study the implementation and effectiveness of~     integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the~     thoracic oncology setting using mixed methods.~   "
18405|NCT02816437|"~     This is a pilot feasibility study to determine whether fecal microbiota transplantation~     (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ~     transplant recipients with a history of one or more MDRO infections.~   "
18386|NCT02816684|"~     Among children, social anxiety is a common, severe and chronic disorder. Social~     Effectiveness Therapy for Children (SET-C) is an empirically supported treatment with~     significant potential to impact the lives of children with this severe and chronic disorder.~     The proposed Pegasys-VR™ system will distinctly enhance its utility, as it will allow~     dissemination to a broad variety of clinical settings including schools as well as~     traditional outpatient clinics. Its use for the treatment of social skills deficits will~     offer a superior solution for mental health personnel, solving many of the resource and~     logistic barriers that they currently face. The final product will address cost and~     practical issues by disseminating an empirically-supported treatment that was rigorously~     built and tested. Using VE will make the traditional social skills therapy programs program~     cost-effective and patient-centric, allowing even clinicians with little background/training~     in behavior therapy to have tools not typically available to them.~   "
18387|NCT02816671|"~     The primary purpose of this prospective, open-label, multi-center observational registry~     with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real~     world setting in thoracic surgical procedures. Procedures may be open or video assisted~     thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective~     and subjective evaluation of the use of the stapler in their procedures.~   "
18388|NCT02816658|"~     Inguinal hernia repair is one of the most commonly performed general surgery operations.~     However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators~     therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia~     surgery repair to robotic inguinal hernia repair surgery.~      The investigators hypothesize that the robotic approach to inguinal hernia repair will~     result in improved post-operative outcomes compared to traditional laparoscopic inguinal~     hernia repairs.~      Specific Aim #1: To determine if the robotic approach will result in a significant reduction~     in postoperative pain and earlier return to full function when compared to a laparoscopic~     inguinal hernia repair.~      Specific Aim #2: To perform a cost analysis to determine the financial implications of~     performing a robotic versus a laparoscopic inguinal hernia repair.~      Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing~     laparoscopic versus robotic inguinal hernia repairs.~      Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic~     versus robotic inguinal hernia repairs.~   "
18389|NCT02816645|"~     The study of non-invasive and reliable biomarkers to track progression of Parkinson's~     disease (PD) is essential while disease-modifying treatments are being developed. Many~     clinical biological or imaging biomarkers have been tested but no gold standard has been~     found as of yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2*~     measurement (R2* = 1/T2*), which is a validated marker for estimating brain iron~     concentration, appears to be an attractive technique because its safety, rapidly measured in~     clinical conditions and its ease to ensure individual longitudinal follow-up. Current data~     of cross sectional studies of R2*, which have shown an iron increase in Substantia Nigra~     (SN), led to suppose that it could be a biomarker of disease vulnerability. Recently, the~     investigators have conducted the first longitudinal follow-up of R2* (1.5 T MRI), which~     showed a rapid R2* increase in both parts of the SN and in the caudal putamen. We propose,~     here, a multicenter prospective study of one-year cohort follow-up of R2* variations (ΔR2*)~     in three regions of interest (ROIs) (the SN, the Ventral Tegmental Area (VTA) and the~     Putamen) of 160 patients with PD, using a 3 Tesla MRI, to evaluate the potential interest of~     R2* as a biomarker of disease progression. The variation of R2* (ΔR2*) will be correlated~     with clinical markers of disease progress, non-motor symptoms. 80 healthy controls subjects~     will also be included to assess the effect of aging on cerebral physiological iron levels.~   "
18390|NCT02816632|"~     The purpose of this research is to identify and probe the neural networks involved in~     feedback processing. It aims at translating this knowledge to clinical populations in which~     this network is disrupted or compromised.~      It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of~     feedback processing on decision making using different types of feedback (neutral, social~     and monetary) presented either infra- or supra-laminary and 2) probing the role of one~     structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in~     healthy subjects. The interventional part consists in the administration of Galvanic~     Vestibular Stimulation (GVS), which by means of small intensity currents activates the~     vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to~     healthy participants engaged in behavioural tasks requiring the processing of feedbacks of~     different nature (e.g. social or monetary feedbacks)~   "
18391|NCT02816619|"~     There is growing interest for physical activity in Parkinson's disease in order to improve~     mobility and function of these patients. It seems from previous studies that difficulty,~     intensity and specificity of physical exercises are important parameters conditioning the~     effect of physical activity on cerebral plasticity and clinical improvement.~      Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity~     coaching program, including scheduled and frequent follow up associated with progressive~     readaptation of exercise intensity depending on individual performances (during 3 months),~     versus free practice of physical activity in Parkinson's disease.~   "
18392|NCT02816606|"~     Following recent advances in the understanding of successful anterior cruciate ligament~     (ACL) reconstruction, three important factors have been identified: femoral tunnel~     positioning, femoral tunnel aperture shape, and native remnant preservation. Accordingly,~     the researchers have adapted their technique to address these goals. This study is designed~     to assess the feasibility of evaluating these graft characteristics, on post-operative~     imaging, and the ability to show potential improvements with the researchers' technical~     changes. The study plans to use three-dimensional computer tomography (3D-CT) and magnetic~     resonance imaging (MRI) to assess these properties and the integration of the graft. In~     addition, the researchers will use their routine functional scores to monitor the patients'~     outcome. If successful, the research team hope to set-up a randomised control trial of this~     alternative technique versus conventional methods with assessment through the same imaging~     mediums and clinical follow-up.~   "
18393|NCT02816593|"~     To evaluate the efficacy, safety and impact on quality of life related to oral health of~     home and office tooth whitening techniques in young individuals.~   "
18394|NCT02816580|"~     Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years~     of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying~     frailty and implementing preventive measures can help to slow cognitive decline. Screening~     and treating frailty seem to be a good start towards preventing dependency.~      On the premise that this frailty is the result of more pronounced tissue alterations in~     certain elderly subjects, assessment of post-translational modification derived products~     (PTMDP) represents an innovative evaluation method. These include advanced glycation~     end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the~     intensity of these modifications increases with ageing, and assessing the products resulting~     from these alterations could show the existence of differences according to frailty status.~     This would make it possible to adapt treatment accordingly in elderly subjects.~   "
18395|NCT02816567|"~     The objective of the study is to describe factors influencing abdominal compliance during~     laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is~     randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance~     is measured by pressure/volume relationship.~   "
18396|NCT02816554|"~     A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX-~     VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in~     Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two~     hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each~     of which receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval.~     Safety issues included immediate reaction at the site of injection and systemic reaction~     within 30 min of administration, solicited and unsolicited adverse events occurs from the~     first dose to 30 days after second dose; SAE (from start of first dose to 30 days after~     second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include~     seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and~     20-22 days post 2nd dose).~   "
18397|NCT02816541|"~     The Pilates Method (PM) has been widely used in the daily practice of many professionals. It~     is well known that anticipatory postural adjustments (APAs) have a strong relation with the~     improvement in performance through motor control improvement. However, no studies have~     investigate the PM exercises performed with pelvis in different positions on the improvement~     of performance, APAs and these influences on motor control. This study aims to compare the~     effects of practicing a single session of Pilates-based therapeutic exercises with posterior~     pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.~   "
18398|NCT02816528|"~     France is a country strong consumer of antibiotics in Europe, specially in primary care.~      Outpatient antibiotic use represents around 90% of total antibiotic use and prescriptions~     come mainly from general practitioners. A literature review of antibiotic stewardship in~     primary care show that there is no evaluation of interest of giving information about~     consumption of antibiotics and bacterial resistance to general practitioners. The objective~     of this study is to demonstrate that practitioners implicated in the followed of consumption~     of antibiotics and bacterial resistance around their geographical area of practice could~     change and improve their practices in good use of antibiotics.~   "
18399|NCT02816515|"~     This is a 3-week, non-interventional, observational study of patients undergoing~     chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of~     Ectoin containing mouthwash given prophylactically for the prevention of mucositis in~     patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for~     patients with mucositis compared to standard treatment should be investigated. The study~     doesn't intervene with routine treatment strategy.~   "
18400|NCT02816502|"~     This study investigates the clinical and neural effects of MBSR for young adults with~     childhood adversity. The investigators will recruit 60 young adults (19-35 years old) who~     will be randomized into a mindfulness based stress reduction(MBSR) program or a cognitive~     psychoeducation (CPE) program, both of which are 8 weeks long. MRI and psychological~     assessments will be acquired from all subjects before and after the intervention programs in~     order to investigate changes in clinical symptoms (such as depression, anxiety and stress)~     and hippocampus structure and function as well as other neural changes.~   "
18401|NCT02816489|"~     Labial alveolar bone thickness and apical root resorption changes associated with~     self-ligating versus conventional brackets.~      The aim of this study will be to compare labial alveolar bone thickness and apical root~     resorption changes associated with self-ligating versus conventional brackets.~   "
18402|NCT02816476|"~     This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult~     patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous~     treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled~     to receive study treatment. Patients will receive treatment until either disease progression~     or toxicity has occurred with a maximum planned of six 28-day cycles.~      Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from~     cycle 3 through cycle 6.~      Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects,~     and to address underlying Amyloidosis, including blood product transfusions, antimicrobials,~     and (as appropriate) growth factors including granulocyte colony-stimulating factors for~     neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia~   "
18403|NCT02816463|"~     The purpose of this study is to determine whether the leak pressure of the recently~     introduced laryngeal mask airway, Ambu AuraGain performs superior to the established~     laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak~     pressure is the pressure at which a gas leaks around the airway, which is a key marker of~     efficacy and safety of its use; a higher leak pressure suggests a better seal between the~     artificial airway and patient's airway.~   "
18404|NCT02816450|"~     The aim of this study is to determine the influence of changes in water intake on changes in~     cognitive function among preadolescent children. Further, the proposed work will determine~     the relationship between urinary markers of hydration process and cognitive function. We~     hypothesize that an increase in water intake will result in greater cognitive performance.~     In addition, improvements in hydration demonstrated by lower urine concentration will be~     correlated with greater cognitive performance.~   "
18459|NCT02815735|"~     The aim of this study is to compare the subjective performance of the comfilcon A contact~     lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.~   "
18406|NCT02816424|"~     Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine~     recommend that teen health providers screen for sexual risk behaviors and provide education~     and counseling to those at risk, there are currently no specific guidelines or protocols~     available to guide such practices, nor have there been any rigorous evaluations of efficacy.~     Preventing teen pregnancy through brief intervention in primary care holds the promise to~     have a significant public health impact and reduce health disparities by engaging,~     educating, and motivating the majority of teens who visit a primary care setting each year.~     In the current study, we seek to rigorously evaluate the impact of brief intervention vs.~     informational control on unprotected sexual intercourse among teens with past year~     unprotected sex at two primary care clinics serving predominately underserved, minority~     populations in New Mexico. The target population for the current study will be 1350 male and~     female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the~     Albuquerque Job Corps Wellness Center. Extensive formative work involving the study~     population will be conducted prior to the trial to refine the motivational~     interviewing-based brief intervention. Eligible youth will be randomly assigned to brief~     intervention or an informational control condition, in addition to regularly offered~     medically-based contraception consultation and prescription services. Follow-ups at 3- and~     9- months will compare rates of unprotected sex and acceptance of long-acting reversible~     contraceptives. Brief education and counseling interventions could be feasibly implemented~     during the greater than eight preventive and acute primary care visits that the average US~     adolescent attends during their teen years. Such an approach could conserve valuable~     resources required by more intensive interventions for nonresponsive teens with greater~     need. Furthermore, social determinants of health, such as poverty and race, that may reduce~     access to more extensive psychosocial interventions, are less likely to prevent access to~     primary care, increasing health equity.~   "
18407|NCT02816411|"~     In this study the investigators utilized protein supplementation over an 8-day period~     following eccentric exercise-induced muscle damage in order to test the initial hypotheses :~     i) protein supplementation after exercise-induced muscle injury affects exercise-induced~     aseptic inflammation and muscle performance.~   "
18408|NCT02816398|"~     Feasibility clinical study to evaluate the safety and effectiveness of the catheter system~     for the percutaneous creation of an arteriovenous fistula for patients with end stage renal~     disease requiring dialysis access.~   "
18409|NCT02816385|"~     Myocardial protection is a fundamental element for the safety of patients when performing~     cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical~     practice to protect the myocardium when performing aortic clamp.~      Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved~     with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled~     perfusate). The composition of the cardioplegic solutions and their method of administration~     continuously changed over the years.~      At the present date, cold blood cardioplegias are performed in the investigator's center.~     The investigators regularly use two modes of administration: either by an antegrade path~     (injection in the coronary arteries), or a retrograde one (injection in the venous system).~     At present, there are no elements supporting the superiority or inferiority of one path~     compared to another. The difficulty lies within a clear estimation of the contractility~     state of the ventricular cardiac muscle.~      Technological developments in recent years provided a solution to this problem. The analysis~     of the pressure/volume curves generated by a ventricle allows an accurate quantification of~     the myocardial contractility. This requires the use of conductance catheters to accurately~     measure the ventricular volume and the ventricular pressure. The absolute ventricular~     contractility is then deduced with the help of a software.~      The investigators intend to use this pressure-volume loops, obtained with conductance~     catheters, to compare the contractility of the right heart ventricle after antegrade vs~     retrograde cardioplegia.~   "
18410|NCT02816372|"~     Despite the use of protective ventilation, neuromuscular blocking agent and prone position,~     ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in~     randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal~     volume over respiratory system compliance) has recently been strongly associated with ARDS~     mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit.~     While extracorporeal CO2 removal technique are currently under investigation in association~     with tidal volume reduction~   "
18411|NCT02816359|"~     Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress~     SyndromeARDS patients in order to set ventilator settings. There might be variations of the~     measured value according to the patient position (0° vs 30°) at the time of measurements.~   "
18412|NCT02816346|"~     Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot~     of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for~     all S. sonnei vaccine candidates. An adaptable dosing plan will be used to determine the~     dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of~     subjects.~   "
18413|NCT02816333|"~     Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B~     aortic dissection who meet all inclusion and exclusion criteria will be included.~      Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be~     followed clinically for 12 months after the procedure. CT will be performed at 12 months.~   "
18414|NCT02816320|"~     In a retrospective cross-sectional study, investigators aimed to valid the variables~     employed to generate standardized mortality ratio from hospital administrative databases.~     For this purpose, investigators have compared those variables collected in administrative~     databases with the information available in patient medical record.~   "
18415|NCT02816307|"~     Infective endocarditis remains a serious disease that requires fast and specialized support~     in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy~     diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for~     markers of inflammatory and tumoral diseases, should increase the number of positive~     etiological diagnosis of culture-negative samples.~      Secondly, because of the seriousness of the disease, the investigators were led to develop a~     new score: score for admission. This score, realized in less than 4 hours from the admission~     of the suspected patient with endocarditis, should allow for immediate probabilistic~     antibiotic treatment after completion of the diagnostic kit. The modified Duke score give~     its results in 4 to 7 days. With the score of admission thus diagnostic processes are~     accelerated and, where appropriate, empirical antibiotic therapy started.~      Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological~     identification of endocarditis.~      Secondary: Validate the admission score compared to the modified Duke score.~   "
18460|NCT02815722|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Simvastatin after the multiple oral doses treatment in healthy adult volunteers.~   "
18416|NCT02816294|"~     Housing Prescriptions as Health Care is a research project studying the effects of an~     innovative intervention that combines services across the health, housing, social and legal~     service sectors in order to improve housing stability and child health outcomes among~     participants. The housing intervention developed for this study specifically addresses~     issues including families who are: paying more than 50 percent of income on rent or~     utilities, moving frequently, experiencing homelessness, but are not eligible for shelter~     through the Department of Housing and Community Development's Emergency Assistance program,~     or were unable to pay rent on time in the past year. This research explores how coordinated~     and comprehensive housing services offered through intensive case management improves~     housing stability and health outcomes for families of young children.~   "
18417|NCT02816281|"~     A retrospective cross-sectional analytic study to evaluation and identification of the~     reasons about Scheduled elective surgical case cancellation in Siriraj Hospital, reason of~     cancellation will be extracted from hospital medical record of each case, reviewed and~     divided into 2 groups, with SiPAC and without SiPAC consultation. Primary outcomes are the~     incidence of cancelled case and causes of the cancellation and secondary outcome that will~     be identified for areas of improvement.~   "
18418|NCT02816268|"~     The investigators prospectively investigate the differences between contact-force guided~     pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with~     paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant~     conduction, procedural and clinical outcome.~   "
18419|NCT02816255|"~     Subjects will all have a two week baseline period in which they will use a nasal mask using~     an air view CPAP machine (which records all data). After the two week period all will switch~     to a full face mask with half using the same CPAP pressure and half with a new a CPAP~     pressure derived from our formula for the final two weeks.~   "
18420|NCT02816242|"~     effect of concept map in teaching critical thinking was done with randomized study~   "
18421|NCT02816229|"~     Massive haemoptysis is a life-threatening condition which is commonly seen in patients who~     have previously had pulmonary tuberculosis. Various treatment options exist such as~     bronchial artery embolisation (BAE) or surgical resection of the affect lung region.~     However, BAE is not considered curative as there is often recurrence of haemoptysis.~     Furthermore, not all patients will be deemed suitable for surgical resection, leaving them~     with very few treatment options. A possible alternative intervention is the insertion of an~     endobronchial valve (EBV). It is speculated that blood will collect distal to the one way~     valve and a thrombus will be formed. There is currently no data describing the use of EBV~     for the treatment of massive haemoptysis. This RCT aims to explore the use and efficacy of~     EBV in the management of massive haemoptysis.~   "
18422|NCT02816216|"~     This project will fully develop and preliminarily validate CampAir, an empirically-based~     dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with~     uncontrolled asthma to learn how to manage their illness and improve their asthma control.~     In addition to developing a highly novel product for adolescents with asthma, the research~     proposed for this project will address unique scientific questions. Despite the high asthma~     prevalence among adolescents, few interventions have specifically targeted adolescents. This~     study is innovative in that it is among the few to focus on adolescents, who are often~     overlooked by the healthcare system. This research will assess factors associated with~     successful implementation of CampAir, thereby providing new information regarding how~     e-health interventions can be effectively developed and implemented for use with adolescents~     with asthma.~   "
18423|NCT02816203|"~     Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible~     for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of~     500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24~     hours after delivery.~      In clinical practice, if after giving birth, the placenta is not expelled naturally, an~     active management should be triggered. After obstetric maneuvers therapeutic, options begin~     with uterotonic treatments before considering invasive treatments such as embolization,~     vessel ligation and hysterectomy. However, the morbidity associated with these techniques~     and the desire to preserve fertility mean that new therapeutic solutions have been~     conceived, which has recently led to the development of an innovative intrauterine~     hemostasis medical device : a hemostatic intrauterine suction cup.~      Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this~     biomedical research, the study of a new medical device. Our hypothesis is that the uterine~     walls will append to the walls of the suction cup after the latter is put under vacuum. The~     actuation of the suction cup will lead to the aspiration of all sides of the uterus.~   "
18424|NCT02816190|"~     Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF~     ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric~     capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned~     patients will be included in the study with usual monitoring (i.e. respiratory system basic~     mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data~     will be collected during all prone position sessions.~   "
18425|NCT02816177|"~     Telemedicine-based care provides remote health and social care to maintain people's autonomy~     and increase their quality of life. The rapidly aging population has come with a significant~     increase in the prevalence of chronic diseases and their effects, and thus the need for~     increased care and welfare.~      This solutions give a new opportunity for diagnosis, treatment, education, and~     rehabilitation, and make it possible to monitor patients with a number of chronic diseases.~     It also reduces socioeconomic disparity with regard to access to care and gives equal~     chances to patients from urban and rural areas.~      This a randomized trial of telemedicine versus usual care alone to reduce hospitalization~     and emergency hospital admissions for Nursing Home Residents .~      After an initial assessment , each participant is monitored by teleconsultation on six~     occasions over 12 months. Patients with usual care have an initial and a 12 months~     assessments.~   "
18461|NCT02815709|"~     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine~     administered as needed (PRN) compared with placebo in patients with moderate to severe acute~     postoperative pain after bunionectomy.~   "
25585|NCT02722291|"~     This study is aimed at presbyopic patients that do not require magnifying glass at close~     rage. The purpose of this study is to investigate the functional and physiological changes~     in eye induced by pinhole glass.~   "
18426|NCT02816164|"~     In patients with early-stage breast cancer, chemotherapy has substantially improved survival~     rates. Improvements in outcomes, however, are compromised by the considerable toxicities~     associated with chemotherapy, the most notable being neutropenia. Neutropenia is the~     presence of abnormally few white blood cells, leading to increase susceptibility to~     infection and can require hospitalization and need for intravenous antibiotics and is~     sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and~     dose reductions, potentially compromising treatment efficacy. Patients can receive~     medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for~     5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to~     which administration schedule of Neupogen is the best for patients, the investigators are~     performing a randomized study for which patients will receive either 5, 7 or 10 days of~     Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10~     days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment which~     would cost half this. In addition to cost savings, many patients are not able to give~     themselves injections on a daily basis and require nursing resources which are utilized at~     high cost. This study will use an oral consent model to compare 5, 7 and 10 days of Neupogen~     to evaluate rates of febrile neutropenia and hospitalization.~   "
18427|NCT02816151|"~     Detrusor hyperactivity is an urodynamic observation defined by involuntary detrusor~     contractions during the vesical filling. Within neurological bladders childs, especially~     related to spinal dysraphisms, this hyperactivity, associated or not with vesical compliance~     disorders, can involve a urinary incontinence obstructing social integration and possibly~     vesical pressure rise in the intra- potentially generating the high urinary tract lesions.~     Anticholinergic drugs possibly associated with a vesical draining constitute the treatment~     of first intention. In approximately 15 to 20% of the cases, intradetrusor iterative~     injections of type A Botulinum Toxin are proposed fault of satisfactory results. Largely~     used according to the European consensus of 2008 without AM, actual studies remain realized~     on small numbers with low level of proof. Posology remains discussed between pharmaceutical~     laboratories (derivative of the effective maximum amount per adult kg of weight) and weaker~     amounts used with clinical results.~   "
18428|NCT02816138|"~     Late-life depression is characterized by both affective (mood) symptoms and cognitive~     deficits. There is currently no intervention that may provide consistent benefits to both~     mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors~     via transdermal nicotine patches may provide benefit to both mood and cognition, working~     through nicotine's effects on brain neural networks, specifically the cognitive control~     network and default mode network.~      In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking~     depressed elders with subjective cognitive impairment. Following baseline neuroimaging and~     cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine.~     Afterwards, participants will repeat neuroimaging and cognitive assessments.~   "
18429|NCT02816125|"~     Healthy premenopausal women were enrolled in a diet intervention study that examined the~     effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In~     a randomized cross-over design, women consumed their habitual diet with a supplement for~     three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with~     the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over~     the 10 month protocol and analyzed for biomarkers associated with supplementation and future~     risk of breast cancer.~   "
18430|NCT02816112|"~     Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy~     regimen in patients with resected early stage breast cancer. TC chemotherapy can cause~     febrile neutropenia (FN) which can be serious and associated with treatment delays and dose~     reductions, thereby compromising treatment efficacy. To reduce the risk of~     chemotherapy-induced FN,TC is administered with either one of two highly effective standard~     treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte~     colony-stimulating factor (G-CSF). However, there are considerable cost differences between~     these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment~     while oral ciprofloxacin costs about $100.~      The investigators have therefore been performing a feasibility study to explore whether the~     integrated consent model involving oral consent is feasible in practice; and whether it~     can be used to increase the number of physicians and patients who take part in clinical~     trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the~     investigators are therefore now performing a definitive study comparing G-CSF with~     ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather~     clinically important endpoints of hospitalizations and febrile neutropenia rates.~   "
18431|NCT02816099|"~     In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is~     slowed down.~      ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that~     regulates cholesterol transfer in the body.~      The aim of this study is to determine whether it is possible to correct apoC1 function by~     improving glycaemic balance.~      240 persons will be recruited in this study and allocated to one of two groups:~        -  160 Type-1 diabetes patients with uncontrolled diabetes:~             -  4 additional blood samples will be taken at the time of the systematic biological~               examination at inclusion and then again 3 months later.~        -  80 control subjects with normal lipids and normal glycaemia balance will be included in~          the study following the results of the biological assays.~             -  4 blood samples will be taken at the time of inclusion.~   "
18432|NCT02816086|"~     Suboptimal use of medications among geriatric patients is well-known problem and leads to~     medication errors, re-hospitalizations and death. By using a randomized controlled trial~     (RCT) design the investigators aim to explore a new inter-professional working structure.~     The working structure is based on the scientifically and clinically acknowledged integrated~     medicines management (IMM) model. The overall aim of the study is to explore the effect of~     the new working structure on the composite endpoint re-hospitalization + visit to an~     emergency department during 12 months after hospital discharge.~   "
18433|NCT02816073|"~     A randomized study to assess the safety and efficacy of single-session pan-retinal~     photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic~     retinopathy (PDR) - 1,700 shots vs 2,500 shots~   "
25586|NCT02722278|"~     A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of~     Oral Testosterone Undecanoate (TU) in Hypogonadal Men~   "
18434|NCT02816060|"~     Background: There is evidence linking conditioned pain modulation (CPM) deficiency with~     musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and~     irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial~     pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic~     pain there is no activation of CPM.~      Objectives: The purpose of this study is to measure the CPM response and determine whether~     neural tensioner exercise in patients with chronic neck pain is effective in the improvement~     of neck pain intensity, neck disability and cervical range of motion.~      Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain~     will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or~     the sham technique (ST) group.~      Individuals will be included in the study if they meet the following inclusion criteria:~     aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from~     the superior nuchal line to the first thoracic spinous process with more than 12 weeks of~     evolution and without radicular symptoms radiated to the head. Neck pain intensity with a~     visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion~     will be measured pre and port intervention.~   "
18435|NCT02816047|"~     Background: The wearable cardioverter defibrillator (WCD) is an established treatment option~     for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF),~     either in whom this risk may only be temporarily present, or in patients at high risk for~     sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator~     (ICD is currently not possible for other reasons (infection, recent MI <40days, recent~     PCI/CABG < 3months etc.).~      Methods: Comprehensive registry including all patients in Austria who received a WCD in~     2010-2016.~   "
18436|NCT02816034|"~     The purpose of this study is to investigate if individuals with a cannabis use disorder have~     an impaired cerebellar function by assessing possible alterations to their implicit~     adaptation during a visuomotor rotation task.~   "
18437|NCT02816021|"~     The goal of this clinical research study is to learn if oral azacitidine (CC-486) and~     pembrolizumab (MK-3475) can help to control melanoma. The safety of this drug combination~     will also be studied.~   "
18438|NCT02816008|"~     Cognitive rehabilitation is defined as a systematic functionally oriented intervention of~     therapeutic cognitive activities based on the assessment and understanding of patient's~     brain behavior deficits. This project focuses on restoring cognitive functions in order to~     understand the underlying deficits in the patient's brain by developing integrated cognitive~     rehabilitation scenarios in virtual reality that combine memory, attention and problem~     solving training with context specific motor movements.~   "
18439|NCT02815995|"~     The goal of this clinical research study is to learn if the combination of durvalumab and~     tremelimumab can help to control sarcoma. The safety of this drug combination will also be~     studied.~   "
18440|NCT02815982|"~     This purpose of this pilot study is to investigate the feasibility of and optimal time post~     cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T),~     as well as assess its preliminary efficacy on specific child health behaviors. The study~     will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in~     EUC (standard care).~   "
18441|NCT02815969|"~     This is an observational and exploratory study. Participants will be asked for a blood~     collection and a 24- hour collection of urine. The indol profile and levels of catecholamine~     and metabolites in PRP, as well as in 24- hour collection of urine will be measured with~     LC-MS/MS and analyzed.~   "
18442|NCT02815956|"~     Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of~     management after colorectal surgery because of an increase of the morbidity rate or of the~     rate of early rehospitalization after discharge.~      Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will~     experiment POI.~      A new approach during preoperative era, using mastication or preoperative physical activity,~     has been proposed to improve postoperative course. This leads to a vagal activation (action~     especially on upper GI).~      Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower~     GI.~      The aim of this study was to assess the efficacy and the feasibility of PTNS during~     perioperative course, to prevent POI with respect with placebo.~   "
18443|NCT02815943|"~     Bariatric surgery procedures have now been firmly demonstrated to lead to significant~     improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in~     type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight~     loss. The most striking anti-diabetic effects are observed with biliopancreatic diversion~     with duodenal switch (BPD-DS), followed by Roux-in-Y gastric bypass (RYGB) and sleeve~     gastrectomy (SG). The first two procedures induce both a restriction of energy intake and a~     low absorption of dietary fatty acids while the latter exclusively targets energy intake~     restriction. The investigator and others have shown that improvement of T2D occurs within~     days after BPD-DS or RYGB in the vast majority of patients, prior to any significant weight~     loss. This very rapid metabolic recovery is explained by a normalization of β-cell function~     after meal challenges and ameliorated hepatic insulin sensitivity. The investigator and~     others have shown that these acute anti-diabetic effects are mostly recapitulated by matched~     caloric restriction, independent of changes in gastrointestinal hormones, showing the~     importance of gastrointestinal-derived energy fluxes for acute diabetes control. Muscle~     insulin sensitivity, on the other hand, improves more slowly in association with weight~     loss, demonstrating the heterogeneous metabolic response of the various organs to BPD-DS.~     Some preliminary studies also demonstrate a rapid reduction of NEFA levels and production~     rate upon i.v. administration of lipids during euglycemic hyperinsulinemic clamps. This very~     rapid improvement in NEFA tolerance strongly suggests that adipose tissue storage of~     circulating fatty acids also improves very rapidly, prior to any significant weight loss,~     after BPD-DS. It may also suggest an acceleration of oxidative fatty acid metabolism in~     organs such as the liver, the heart and/or skeletal muscles. Studies of the rapid metabolic~     changes after bariatric surgery conducted thus far rapidly improved the understanding of the~     fundamental pathogenic defects of T2D. However, much remains to be understood about the~     acute changes in gastrointestinal-derived metabolic fluxes, organ-specific metabolic~     responses to bariatric surgery and their relationship with the reversal of T2D. Using in~     vivo methodological approaches, the investigator proposes to investigate the early~     organ-specific changes in dietary fatty acid metabolism in response to BPD-DS vs. SG and~     their relation to improved systemic changes in glucose homeostasis, insulin sensitivity and~     β-cell function in patients with T2D.~   "
18444|NCT02815930|"~     High cost users (HCUs) are a small group of patients who use a disproportionate amount of~     health care resources. This study is a retrospective population-based matched cohort~     analysis of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years~     or older in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013). The~     study objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on~     their demographics, co-morbidities, medication use, health service utilization, healthcare~     expenditures, medication costs and clinical outcomes, and to determine the relative~     contribution of medications to senior HCUs expenditures~   "
18445|NCT02815917|"~     Preclinical work suggests that D3 dopamine receptors may be important in the study of the~     pathophysiology of affective disorders, psychotic disorders and addiction. D3 receptors may~     also play a role in dystonia, Parkinson's disease and response to treatment of these~     disorders. However, there has been a lack of specific radioligands for imaging D3 receptors.~     This proposed protocol will evaluate the uptake of [18F]FTP as a more specific in vivo~     measure of D3 receptor binding in the brain in healthy volunteers subjects after injection~     of lorazepam vs placebo, and in cocaine-dependent subjects. Test-retest scans will evaluate~     the variability of [18F]FTP uptake measures in both healthy volunteer subjects and~     cocaine-dependent subjects.~   "
18446|NCT02815904|"~     The role of physiotherapy interventions in treatment of high risk infants has not been~     established even after a number of studies. The high risk infants are prone to developmental~     delays and early intervention is most effective for them owing to the plasticity of brain in~     early infancy. Yakson is one among the most effective and safe methods of tactile~     stimulation for preterm neonates. Tactile and kinesthetic stimulation techniques have been~     proved to be effective but there is no standardized protocol. The present study will try to~     investigate the efficacy of Yakson touch in combination with kinesthetic stimulation on the~     development of high risk neonates against conventional handling which will include~     developmental positioning and Kangaroo mother care.~   "
18447|NCT02815891|"~     TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL~     or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients~     with NAFL or NASH within academic and community real-world practices in order to assess the~     safety and effectiveness of current and future therapies.~   "
18448|NCT02815878|"~     This project is an adaptation trial, testing the efficacy of an evidence-based community~     wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in~     a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury,~     post-polio syndrome and muscular dystrophy.~   "
18449|NCT02815865|"~     The investigators intend to conduct a randomized clinical trial comparing 3 methods of~     induction of labor in term primiparous women with singleton. First group will be women~     induced with Foley catheter and pitocin, second group Foley catheter and vaginal~     dinoprostone and third group will be induced with vaginal dinoprostone alone. The~     investigators compare time for induction to delivery and way of delivery.~   "
18450|NCT02815852|"~     The purpose of this study is to review retrospectively cases of breast cancer of the centers~     belonging to the BREST UNIT Tuscany North-West Wide Area and compare the imaging~     characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer with~     the corresponding histological reports and assess whether in women <40 years the typical~     imaging presentation pattern of malignancies observed in women> 40 years are confirmed.~   "
18451|NCT02815839|"~     The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic~     and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy~     volunteers.~   "
18452|NCT02815826|"~     The purpose of this study was to evaluate the influence of 16 weeks of progressive barefoot~     running training on impact force and muscle activation in habitual shod runners. Habitual~     shod runners were tested barefoot (BF) and shod (SH), before and after 16 weeks of~     progressive barefoot running training. Tests consisted of running on instrumented treadmill~     at 9 km/h, for 10 minutes in each experimental condition. Nine data acquisitions (10 s) of~     vertical ground reaction force (VGRF) and electromyographic (EMG) signal were conducted in~     each experimental condition, for each test.~   "
18453|NCT02815813|"~     This is a four year project evaluating the effectiveness of a group-based lifestyle~     intervention (PeerFIT) supported by mHealth technology and social media compared to Basic~     Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT)~     in achieving clinically significant improvements in weight loss and cardiorespiratory~     fitness in young adults with SMI.~   "
18454|NCT02815800|"~     ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient~     acting alongside vitamin B2. It is proposed in patients with visual problems. Based on~     clinical and experimental data, the investigators propose a pilot open study in order to~     test the efficacy of Ethnodyne visio in patients with Parkinson 's disease (PD). The~     hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients~     with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.~   "
18455|NCT02815787|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers~     respectively.~   "
18456|NCT02815774|"~     The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency~     Patients.~   "
18457|NCT02815761|"~     Chronic obstructive pulmonary disease (COPD) is a common disease worldwide with a high~     burden on healthcare resources. The prevalence of COPD varied from 11.4 to 26.1% according~     to a recent multi-city population study using spirometry. In Hong Kong (HK), the prevalence~     rates of COPD in the elderly population aged ≥60 years were 25.9% and 12.4% based on the~     spirometric definition of forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)~     ratio <70% and the lower limit of normal of the FEV1/FVC respectively. In 2005, the crude~     mortality rate of COPD was 29.1/100 000, while the crude hospitalization rate was~     193/100,000 in HK. In HK, COPD ranked second as a respiratory cause for hospitalization. In~     those 75 years or older, the hospitalization rate for COPD was as high as 2,225/100,000. The~     economic burden of COPD on the society is enormous.~      Previous studies gave information on the overall morbidity, mortality and the prevalence of~     COPD in HK. One study compared the management of COPD patients in HK with other countries~     and found that COPD patients in HK were under-treated. No large scale study has looked into~     the details of COPD patients in HK, like their co-morbidities and how they are being treated~     and how these factors affect the readmission of these patients. Large prospective studies~     which incorporate all the potentially relevant variables are required to refine prediction~     of the important outcomes of AECOPD and thus to inform clinical decision making, for example~     on escalation of care, facilitated discharge and provision of palliative care.~   "
18458|NCT02815748|"~     The purpose of the study is to investigate the Metabolite identification and material~     balance of SP2086 in healthy adult volunteers.~   "
18462|NCT02815696|"~     Degenerative disc disease (DDD) is the primary cause of low back pain. The most important~     factor in the development of DDD is the vertical load force on the disc, increasing the~     hydrostatic pressure and facilitating discs degenerations. One of the most common conditions~     accompanying DDD is segmental instability of the spine. The pathogenesis evolves in three~     phases characterized by a progressive disc dehydration and loss of the disc height.~      This phenomenon can be observed in magnetic resonance imaging (T2 weighted MRI) as a~     decrease of the water signal inside the intervertebral disc. It is considered as an indirect~     sign of the alteration of the composition (including glycosaminoglycans) and the structure~     of the intervertebral disk with, as consequence, a modification of the spine biomechanics.~     Animal studies showed that disc regeneration could be enhanced by a decrease of the~     hydrostatic pressure. This could be observed as a signal increase on T2 weighted MRI.~      Recent quantitative MRI sequences now allow the quantification of glycosaminoglycans (GAG)~     concentration inside the cartilage and in the intervertebral disc.~      The actual surgical trends are in favor of an anterior (intersomatic) vertebrak fusion,~     associated or not with a posterior fusion. These technics sacrifice the intervertebral disc~     and change the spine biomechanics.~      Based on a pilot study, the investigators believe that the conservation and even a~     regeneration of the intervertebral disc is possible and allows the preservation of the spine~     biomechanics.~      The purpose of the study is to analyze the relations between specific MRI signals, the GAGs~     concentration, and the functional outcome before and after the surgical treatment.~   "
18463|NCT02815683|"~     Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials,~     improving lung function, exercise capacity and possibly survival and are now being adopted~     by a number of centres in the Netherlands. It is important to ensure that the benefits seen~     in clinical trials are in fact reflected in clinical practice and that the best use of this~     early 'real world' experience is made to optimise the development and use of these novel~     therapies.~      Overall objective: to develop a national database to record bronchoscopic lung volume~     reduction procedures for patients with emphysema. This is desirable for audit purposes but~     will also be an important resource for research both in gathering data and in facilitating~     collaborations.~   "
18464|NCT02815670|"~     The trial objective is to demonstrate the safety of idarucizumab, as assessed by the~     occurence of patients with drug related adverse events (including immune reactions) and~     all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in~     ongoing clinical trials who require emergency surgery/urgent procedures or patients who have~     life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid~     reversal of the anticoalugant effect of dabigatran is needed.~   "
18465|NCT02815657|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Valsartan after multiple oral doses treatment in healthy adult volunteers.~   "
18466|NCT02815644|"~     The trial will be performed as an open-label, randomised, single-dose, two-sequence~     crossover design for the assessment of effect of food on bioavailability of empagliflozin /~     linagliptin fixed dose combination (FDC) tablet.~   "
18467|NCT02815631|"~     The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow~     reserve (FFR), with a new method that is based on taking a detailed 3D ECG called~     Cardiogoniometry (CGM).~      FFR is an angiographic technique which measures the physiological significance of a coronary~     stenosis and trial data has shown that basing management decisions on this data improves~     prognosis. However FFR studies are expensive and invasive, whereas CGM is painless and~     simply involves placing 4 sticky pads to the patient's chest / back and is similar to an ECG~     (heart tracing). The investigators want to see whether we can use this new method to find~     out whether treatment with coronary angioplasty would be of benefit. If so, then in the~     future, clinicians could use this method (CGM) rather than pressure wire assessment (FFR).~     This would have several advantages; in particular, it can be easily performed in the clinic~     and avoids the need to use an expensive pressure wire.~   "
18468|NCT02815618|"~     Feasibility trial on the use of a hybrid optical device integrating time-resolved~     near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement~     of cerebral oxygen metabolism and blood flow in neonates.~      The device wil be tested in four settings measuring:~        1. Changes in cerebral oxygenation and haemodynamics after birth~        2. precision and repeatability~        3. The cerebral vaso-reactivity to arterial carbon dioxide~        4. Assessment of the user-friendliness and loss of signal in routine care~   "
18469|NCT02815605|"~     The incidence of severe post-partum hemorrhage has been increasing in developed countries.~     The reason for this is at least partially unknown. Surgical techniques, holistic treatment~     protocols and strategies in blood product administration may have changed patient outcome~     and, for example the incidence of transfusion related side effects. A retrospective analysis~     of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made~     to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during~     delivery) and examine the possible change in blood transfusion strategies and its effect on~     bleeding (for example, implementation of massive transfusion protocol, amount of blood~     products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological~     agents for coagulation management, introduction of new angiological and surgical techniques~     etc.) and complications, laboratory parameters and patient outcome.~   "
18470|NCT02815592|"~     The purpose of this this study is to administer BMS-986012 in Combination with Platinum and~     Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.~   "
18471|NCT02815579|"~     The purpose of this study is to determine whether this multisectoral agricultural and~     microcredit loan intervention improves food security, prevent antiretroviral treatment~     failure, and reduce co-morbidities among people living with HIV/AIDS.~   "
18603|NCT02813837|"~     This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric~     antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell~     derived leukemia and lymphoma that is relapsed (after stem cell transplantation or~     chemotherapy) or refractory to chemotherapy.~   "
18673|NCT02812927|"~     This study compared two methods of insulin infusion by syringe pumps to assess the impact of~     medical devices on the glycaemic variability in patients under IIT in ICU. The main~     objective of the study was to show the superiority of the infusion system which permitted to~     dedicate a line for the insulin administration on the standard installation in terms of~     control of glycaemic variability.~   "
18472|NCT02815566|"~     Design: Double-blind placebo controlled randomised multicenter international strategic trial~     of older women on combination antiretroviral therapy (cART) containing~     tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate~     switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the~     third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48~     weeks while continuing the third agent. Follow up of all subjects to 96 weeks.~      Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years~     (peri or early post menopause). .~      Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar~     spine at weeks 48 and 96.~      Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by~     high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality,~     geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral~     suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and~     96.~      Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree~     correlating with a decreased risk of fragility fracture in aging HIV infected women.~     Secondary outcomes will assess bone strength using new imaging modalities, timing of switch,~     and renal health. This data will be used by health policy makers and providers to determine~     the proper use of TAF?FTC in the aging HIV population.~   "
18473|NCT02815553|"~     Currently, surgical removal remains the main clinical treatment for cardiac tumor patients.~     However, malignant tumors are hard to completely resect. Also, as thoracoscopic surgeries~     induce great operation trauma, some patients cannot tolerate or do not will to take the~     operation. Therefore, new methods and techniques are in urgent need.~      Our center have a 12-year experience of intervention treatment for solid tumors and has~     conducted several animal experiments to verify the effectiveness of transthoracic puncture~     ablation and radiofrequency ablation for ventricular muscle.~      The purpose of this study is to conduct new method of direct transthoracic cardiac~     tumor-targeted Radiofrequency Ablation (RFA) and Laser induced Interstitial Thermotherapy~     (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the~     safety and validity of intervention treatment in long term.~   "
18474|NCT02815540|"~     The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical~     function and the autonomic nervous system in children with Dravet syndrome (DS) and~     Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained~     through state dispensaries or other sources. The intent is to begin to assess potential~     risks and benefits of this therapy in a vulnerable patient population by characterizing the~     effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.~   "
18475|NCT02815527|"~     This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20~     ventilated ICU patients. The primary endpoint of study is the feasibility to attain the~     individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU~     admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid~     response in blood.~   "
18476|NCT02815514|"~     The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic~     valve treatment and the therapeutic consequences are documented.~   "
18477|NCT02815501|"~     Obstetric complications are common and can be responsible for maternal and foetal morbidity~     and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric~     complications.~      Many studies have been conducted to estimate the prevalence and define the nature of~     obstetric complications observed in patients with thyroid dysfunction. However, women with~     obstetric complications are not systematically screened for thyroid dysfunction and no~     published study has evaluated the prevalence of thyroid dysfunction in women with an~     obstetric complication. As no consensus has been reached concerning systematic screening for~     thyroid dysfunction in pregnant women, the identification of new high-risk populations could~     possibly result in a change of clinical practice.~   "
18478|NCT02815488|"~     CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an~     anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of~     this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD~     patients. This study is the first administration in humans.~      The study will comprise four parts:~      Part 1 will consist of two cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.~      Part 2 will consist of four cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.~      Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297~      Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect~     of a repeat dose of CHF6297 after LPS challenge.~   "
18479|NCT02815475|"~     This trial will be conducted for the BBC. The aim of the project is to assess if consuming~     the spice turmeric every other day, in the amount consumed in a curry, can reduce cell~     damage and inflammation. The results of the project will be used to inform the TV program~     Trust Me I'm a Doctor.~   "
18490|NCT02815332|"~     This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled~     study.~      Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply~     1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each~     night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will~     be performed to assess efficacy.~      Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the~     level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical~     examination, clinical laboratory tests, cutaneous tolerance score, incidence of~     minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or~     headaches suggestive of pseudotumor cerebri, and collection of adverse events.~   "
18675|NCT02812901|"~     This study aims to understand the impact of time-of-the day on human myocardial tolerance to~     ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery.~     Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or~     aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery~     based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking~     ischemia-reperfusion.~   "
18480|NCT02815462|"~     In an earlier study using electronic health records (EHR), the investigators have identified~     nine factors to be significantly associated with FA risk. These nine predictors include~     Furosemide intravenous 40 milligrams or more; Admissions in the past one year; Medifund~     status; Frequent emergency department use; Anti-depressants treatment in past one year;~     Charlson comorbidity index; End Stage Renal Failure on dialysis; Subsidized ward stay and~     Geriatric patient. The investigators have combined these nine predictors into the~     FAM-FACE-SG score for FA risk (defined as 3 or more inpatient admissions in the following 12~     months). The FAM-FACE-SG risk score has the advantage of being deployed in our hospital's~     enterprise data repository known as Electronic Health Intelligence System or eHINTs for~     short, on a real-time or near real-time basis. On a daily basis, data from multiple data~     sources are extracted, transformed and loaded onto the eHINTS system. The system can be~     programmed to run every midnight to provide risk scores the following morning for patients~     admitted the previous day.~      In this trial, the intervention is to combine the FAM-FACE-SG risk score in addition to a~     decision making algorithm to guide referrals to various transitional care services based on~     needs assessment on nursing and function. The primary objective is to evaluate the impact of~     our intervention in improving healthcare utilization (hospital readmissions, emergency~     department (ED) attendances, length of stay up to 90 days post-discharge).~   "
18481|NCT02815449|"~     The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron~     fortification can be an effective strategy to decrease this.~      In the current study adding different levels of a stabilizer to iron fortified cubes and~     it's effect on iron bioavailability from these cubes will be studied in the context of a~     Nigerian meal in women.~      24 Female subjects with low serum ferritin levels will be included in the study. The study~     will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with~     a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The~     absorption of iron will be evaluated after every period and compared between the cubes.~   "
18482|NCT02815436|"~     Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the~     third most common cancer in men and the second common in women worldwide, accounting for~     approximately 10% of all cancers.~      Randomized controlled studies have shown that CRC screening using Faecal Occult Blood~     Testing (FOBT) is effective in reducing cancer mortality by 15-33%. Since yearly testing is~     recommended to maintain programmatic effectiveness, longitudinal adherence is a critical~     component of FOBT-based screening programs. The investigators previous study conducted in~     Hong Kong showed that the rate of compliance with CRC screening was declining since the~     first year of enrolment.~      Nevertheless, it remains unknown whether interventions based on reminder systems could~     effectively enhance longitudinal compliance with FOBT, especially among those who have~     already enrolled in a CRC screening programme. Current evidence does not adequately compare~     whether interactive or one-way reminder messages are superior to usual care (i.e. no~     reminders).~   "
18483|NCT02815423|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.~   "
18484|NCT02815410|"~     Prospective, open-labeled, multicenter cohort trial for validation of the role of~     levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed~     glioblastoma patients.~   "
18485|NCT02815397|"~     Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1~     week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after~     last cycle of chemo-immunotherapy.~      DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given~     intrathecally each cycle to patients deemed appropriate by treating physician).~      Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more~     cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease~     will go on to salvage therapy off study.~   "
18486|NCT02815384|"~     The research goal is to continue to add to the extensive body of peer-reviewed evidence that~     demonstrates MRI may be safely performed in patients with cIEDs, after they have been~     evaluated and cleared by cardiology. This study will allow the researchers to collect data~     from the facilities ongoing clinical practice regarding the number and types of any adverse~     clinical reactions, and also to document any changes in the implanted cardiac device that~     may have occurred during the MRI scan. The researchers will also be assessing the results of~     the MRI and how the imaging findings impact patient care and the clinical outcome of the~     patient. This data will then be presented to the FDA and the Centers for Medicare and~     Medicaid Services to further influence federal guidelines and payment structures.~   "
18487|NCT02815371|"~     This study evaluated whether laser acupuncture at the time of embryo transfer (following in~     vitro fertilization) improves implantation rates. Patients were randomized to one of 4~     groups at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham~     laser acupuncture, 4) no treatment.~   "
18488|NCT02815358|"~     This study aims to verify the effects of a segmental stabilization exercise program on the~     anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be~     assessed by means of superficial electromyography focused on the registry of the onset of~     multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder~     ﬂexion/extension.~   "
18489|NCT02815345|"~     During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is~     difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA),~     definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was~     32% . In the same study, the median number of attempts before achieving a final withdrawal~     was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and~     little studied. It seems that the type of interface used, mask or cannula, having an~     influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by~     non-invasive ventilation are not uncommon, regardless of the interface used . In a recent~     randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and~     non-invasive ventilation mode. It is in this case external damage. But we assume that the~     breakdown causes internal lesions dependent on the pressure, humidity and flow. These~     factors are likely to generate a nasal obstruction, source intervention nurses who aspire~     nasal passages more or less traumatic.~      The nasal cavities are often abused and, because of their key role in breathing, could be~     involved in the withdrawal of ventilatory failure~   "
18491|NCT02815319|"~     Docetaxel chemotherapy is commonly used in patients with breast cancer. With the widespread~     use of steroid premedication, the incidence of fluid retention and skin toxicity side~     effects has been minimal. Premedication with dexamethasone (8mg twice daily) is recommended~     starting the day before chemotherapy and continuing for three days. Patients may forget to~     take all or part of their premedication prior to docetaxel administration, and additional~     doses of steroids are frequently give in place of the forgotten oral dose. The processes~     around treating patients who have incorrectly taken their medication are cumbersome leading~     to significant delays in patients receiving their chemotherapy while the chemotherapy nurse~     tries to contact the patients treating physician for guidance on the dose and route of~     dexamethasone they want administered. Most importantly with the current standard of care~     procedure, by the time the chemotherapy nurse, pharmacist and medical oncologist have spoken~     and made a treatment plan, the patient has been waiting for on average of an additional 1-2~     hours before actually starting their chemotherapy.~   "
18492|NCT02815306|"~     Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in~     children. The Ponseti method is an effective protocol for treatment of congenital idiopathic~     clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace~     that can be used for the treatment of clubfoot in newborns and infants instead of plaster.~   "
18493|NCT02815293|"~     The objectives of this study are twofold~        -  To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily~          compared to its vehicle in patients with evaporative dry eye (EDE)~        -  To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily~          in patients with EDE~   "
18494|NCT02815280|"~     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical~     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne~     vulgaris.~   "
18495|NCT02815267|"~     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical~     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne~     vulgaris.~   "
18496|NCT02815254|"~     The focus of this project are elderly people who have experienced hip fracture and need at~     least two weeks rehabilitation after discharge from hospital. The aim is to increase the~     evidence-based knowledge base for planning and appropriate follow-up intervention for~     patients with hip fracture on short-term / rehabilitation stays. In this study the~     investigators want to explore whether training High Intensity Functional Exercises (HIFE) ,~     of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a~     significant positive effect on physical function, pain and quality of life. The main aim is~     to explore whether a high intensive strength and balance training program has better effect~     than a low intensive strength and balance training program on functional status measured by~     Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to~     explore whether this high intensive strength and balance training program has better effect~     than a 'low intensive strength and balance training program' on pain, endurance and quality~     of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36.~     The study is a randomized controlled trial.~   "
18497|NCT02815241|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
18498|NCT02815228|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
18499|NCT02815215|"~     Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though~     Ponseti method can cure most of the CCF patients, there are still part of patients can not~     get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ.~     Carroll's technique is considered to be an ideal method of surgical treatment. But the~     postoperative scar is relatively large, and accordingly the postoperative complications is~     still common. Based on the clinical practice of the investigator's group, a modification of~     Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio~     grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the~     investigator conducted a multicenter randomized controlled trial on treatment of congenital~     idiopathic clubfoot with minimally invasive Carroll's technique.~   "
18500|NCT02815202|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
18501|NCT02815189|"~     Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits~     treatment of teeth with necrotic pulp and apical periodontitis after a two-year control~     period.~      110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working~     length was established with EAL and confirmed radiographically. M4 system with Flex-R files~     were used to complete canal preparation. Level of discomfort were recorded and cases with~     severe postoperative pain and/or swelling were classified as flare-ups.~   "
18502|NCT02815176|"~     Thrombotic biomarkers and angiographic characteristics were compared among the de novo~     patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV)~     and the control.~   "
18503|NCT02815163|"~     Degenerative arthritis is a common and serious chronic illness that impacts the quality of~     life of older adults. Knowledge about the effects of empowerment education program in older~     adults with total hip replacement surgery are limited. As far as the investigators know,~     this is the first study done using empowerment education intervention to promote total hip~     replacement patients' self-care. This partnership is achieved through active participation~     to learn as well as sharing their knowledge and experiences with clinicians and patients.~     Furthermore, patients had developed some degree of self-efficacy and improve their~     depressive mood from the disease related knowledge acquired.~   "
18504|NCT02815150|"~     This study aims to assess the impact of preoperative oral carbohydrate drink on gastric~     emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore,~     investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate~     in elective gastric cancer surgery, providing direct evidence for clinical practice.~   "
18505|NCT02815137|"~     The purpose of this study is to determine if the XPO1 E571K mutation could be used as~     molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the~     interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and~     specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax~     determined by Positron Emission Tomography after C2 and at end of treatment.~   "
18506|NCT02815124|"~     Cochlear implants are surgically implanted devices which restore the ability to hear to the~     hearing impaired. While remarkably successful, even in the best of performers restoration of~     hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,~     cochlear implants are activated via mapping - a process in which each individual electrode~     (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the~     stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At~     present, this standard of care mapping procedure is performed without knowledge of the~     physical location between the cochlear implant electrodes and the neural interface. Our team~     has developed a new method of mapping using post-operative CT scans and image processing to~     specify the physical relationship between the cochlear implant electrodes and the neural~     interface allowing customized mapping. Using this information, the investigators deactivate~     sub-optimally positioned electrodes. The investigators term this Image-guided Cochlear~     Implant Programming (IGCIP). In a prospective fashion, the investigators have implemented~     IGCIP on cochlear implant recipients who have had at least 6 months of standard of care~     (SOC) mapping. The purpose of this study is to perform a randomized controlled trial (RCT)~     on newly activated cochlear implant recipients randomizing between IGCIP and SOC.~   "
18507|NCT02815111|"~     The purpose of this research study is to see if pain can be better controlled with fewer~     side effects. The new drug regimen will study several different medicines that have~     different ways of treating pain.~   "
18508|NCT02815085|"~     The primary objective is to examine feasibility of incorporating RecoverLINK into the~     standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii)~     workflow efficiency. As secondary objectives, the investigators will collect preliminary~     data to examine the association between patient engagement with the RecoverLINK app and (i)~     changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and~     90-day time periods post-enrollment.~   "
18509|NCT02815072|"~     Medical researchers of National Heart Centre Singapore will carry out a state-of-the-art~     study that examines the possibility of changing patients' own cells into multi-functional~     and potent stem cells called iPS cells. These iPS cells can subsequently give rise to~     functional cardiac cells (myocytes) and other cardiovascular cells which might give further~     clues into the manifestation of the structural heart disease. This study involves blood~     sample collection for pre-screening and skin biopsies to establish skin cell culture.~   "
18510|NCT02815059|"~     This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and~     multi-dose study evaluating the use of ibrutinib in combination with dasatinib and~     prednisone therapy.~   "
18511|NCT02815046|"~     This study compares mixed urinary incontinence symptoms before and after a combined~     treatment with Botox and Bulkamid. Eligible for the study are adult females with a mixed~     urinary incontinence, having both urgency urinary symptoms and stress urinary symptoms.~   "
18512|NCT02815033|"~     The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron~     Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance~     Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements~     in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic~     Prostate Cancer patients.~      The study will assess how these 2 imaging modalities perform compared to traditional serial~     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and~     response to treatment with Enzalutamide.~      In addition measurements of serially collected circulating tumour cell (CTC) samples,~     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value~     in terms of response measurement.~   "
18513|NCT02815020|"~     The purpose of this project is to use the Agency for Healthcare Research and Quality patient~     self-management support tools and resources across four practice-based research networks and~     16 member practices using a community-based participatory intervention called Boot Camp~     Translation.~   "
18514|NCT02815007|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI~     for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer~   "
18515|NCT02814994|"~     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically~     diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main~     causes of death in patients. There is no unified treatment process for ARDS currently and~     the treatment measures are not yet standardized, so the standardization of ARDS treatment~     processes is needed to reduce mortality in patients. Following the evidence-based medicine~     principles and six-step treatment standards of ARDS, this study uses the method of~     multi-center randomized controlled clinical trials to evaluate the standardized treatment~     process of ARDS, which provides the basis for the standardized treatment of ARDS.~   "
18516|NCT02814981|"~     On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared~     an information for general practicioners, pediatricians, anesthesiologists, dermatologists,~     geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and~     the associated risk of QT prolongation on the electrocardiogram.~      Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in~     France in various indications including the treatment of minor manifestations of anxiety,~     premedication with general anesthesia and the symptomatic treatment of urticaria.~      A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which~     can cause sudden death. We distinguish congenital and acquired long QT interval. The main~     cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1.~     Many drugs have been reported to cause sudden death by prolongation of QT interval and~     occurrence of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The~     molecules based on hydroxyzine are known to be at risk of prolongation of QT interval in an~     experimental point of view but is not clearly identified in daily clinical practice.~     Pharmacology unit of Caen was the first to publish a case of QT prolongation under~     hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has~     been added to the list of drugs that can induce QT prolongation .~      Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were~     changed daily and therefore the risk of QT prolongation persists. We therefore propose the~     study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in~     patients hospitalized at the University Hospital of Caen.~   "
18517|NCT02814968|"~     The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron~     Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging~     (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in~     response prediction to treatment with Enzalutamide in castration-resistant prostate cancer~     patients.~      The study will assess how these 2 imaging modalities perform compared to traditional serial~     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and~     response to treatment with Enzalutamide in castration-resistant prostate cancer patients.~      In addition measurements of serially collected circulating tumour cell (CTC) samples,~     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value~     in terms of response measurement.~   "
18518|NCT02814955|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing~     prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these~     pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency~     or cryotherapy) has become in this context recognized and effective treatment of AF. In~     addition, antithrombotic treatments in this context is a major treatments for the prevention~     of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent~     recurrence of AF or to slow it during a relapse.~      Recent experimental studies have highlighted the direct electrophysiological properties of~     dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran~     demonstrated in this study that it induced a prolongation of potential action in the~     pulmonary veins and the left atrium and it decreased the incidence of FA-induced by~     stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left~     atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin~     have not been studied in this context.~      It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK~     (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins~     and on the left atrium and could influence AF recurrences (with effect  antiarrhythmic-like~     or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the~     University Hospital of Caen on very low numbers suggest that patients on dabigatran would~     have less pulmonary veins connected in early ablation procedure that patients on warfarin or~     rivaroxaban. Despite the limitations inherent in this analysis (very low numbers,~     retrospective analysis, unique setting and having studied his own limits), these results are~     consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to~     obtain more statistical power and reliability in our measurements and results.~      We therefore propose the study of the electrophysiological effects of NACOS (apixaban,~     dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and~     the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or~     cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.~   "
18519|NCT02814942|"~     Aim:To determine the baseline characteristics of heart failure patients in Singapore~     undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of~     response to CRT.~      Methodology:Among patients undergoing CRT for severe heart failure according to indications~     stipulated in international Cardiology guidelines, baseline demographic data is collected.~     Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left~     bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular~     ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance~     are collected. In addition, during the CRT implant procedure, blood is drawn from the~     vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure.~      The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and~     12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV~     (left ventricular end-systolic volume index to body surface area) of >/= 15% and/or an~     increase in the LVEF of >/= 10%.~   "
18520|NCT02814929|"~     The study includes preterm infants who are being screened for ROP between April 1,2016 and~     April 1, 2017 in 83 neonatal intensive care units (NICUs) in Turkey. Infants with birth~     weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or~     gestational age (GA) >32 weeks with an unstable clinical course are included. The incidence~     of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP~     development will also be evaluated.~   "
18521|NCT02814916|"~     To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute~     bacterial skin and skin structure infections in children, aged 3 months to 17 years, known~     or suspected to be caused by susceptible Gram-positive organisms, including~     methicillin-resistant strains of Staphylococcus aureus.~   "
18522|NCT02814903|"~     Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring~     after cardiac surgery, contributing to prolonged intensive care and hospital stays and is~     associated with several cardiovascular complications. The exact mechanisms and signaling~     pathways involved in the development of POAF seem to be multifactorial and remain to date~     incompletely understood. β-blockers and amiodarone are the first line preventive drugs but~     are partially effective and near 30% of POAF resist to these strategies. In this context,~     there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3~     (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could~     be very useful predictive biomarkers of POAF and potentially interesting therapeutic target~     to prevent POAF occurrence.~      The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3~     (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive~     of POAF in patients undergoing elective CABG surgery with preserved LVEF.~   "
18523|NCT02814890|"~     The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine~     could extend the pain relieve time compared with only ropivacaine when thoracic~     paravertebral block is performed at the end of video-assisted pneumonectomy.~   "
18524|NCT02814877|"~     The main objective of the project is to evaluate the efficiency and cost-effectiveness of~     different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first~     section of the project, the project team intend to map the different antimicrobial~     stewardship programs in French hospital, by investigating a sample of 30 healthcare~     facilities, and determine the strategies to be evaluated by the model. The investigators~     will also evaluate physicians' adherence to the intervention to promote better use of~     antibiotics and explore potential barriers and facilitators to the implementation of~     effective strategies.~   "
18560|NCT02814409|"~     The principle research question is: in patients with acute ischaemic stroke eligible for~     intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on~     functional outcome as assessed by modified Rankin Scale distribution at day 90?~   "
18696|NCT02812628|"~     This study is designed to compare the short-term and long-term benefits between conventional~     laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal~     individualized levator transection (TILT).~   "
18843|NCT02810743|"~     Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant~     phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer~     patients) comparing optimized standard-dose chemotherapy with intensified, alkylating~     chemotherapy with stem cell rescue.~   "
18525|NCT02814864|"~     Patients receiving radiation therapy are still at risk for side effects due to off-target~     radiation damage of normal tissues The number of cancer patients is expected to increase~     from 14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will~     develop late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD).~     Symptoms are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality~     of life. The treatment of PRD is limited to managing the symptoms; new alternatives should~     be proposed.~      Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the~     feasibility to used MSCs in these pathologies :~        -  MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with~          hemorrhagic cystitis, perforated colon and peritonitis.~        -  Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results~          suggest an inhibition of chronic inflammation and fistulization and interruption of~          hemorrhagic syndromes.~        -  Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in~          progress.~        -  A decrease in pain after the injection of MSCs was observed in patients treated by~          radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage.~        -  Four patients, were treated with MSCs after receiving overdose pelvic irradiation for~          prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed.~      MSCs will represent a promising alternative strategy in the treatment of severe enteritis,~     rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish~     the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.~   "
18526|NCT02814851|"~     The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed~     during the third week of gestation. LAA is believed to function as a decompression chamber~     during left ventricular systole and other periods when left atrial pressure is elevated. The~     LAA is also a major endocrine organ and is the main producer of ANP (atrial natriuretic~     peptide) in the human heart. The ANP concentration is 40 times higher in the LAA walls than~     in the rest of the atrial wall. A study of patients having undergone the maze procedure and~     associated LAA removal found a significantly lower ANP secretion and an increase in salt and~     water retention. Whether this could eventually lead to hypertension or heart failure~     symptoms is not known.~      Removal of the LAA is routinely performed during antiarrhythmic surgical techniques (MAZE~     surgery) to reduce the risk of subsequent LAA thrombus. Furthermore, new percutaneous~     ablation techniques target LAA to reduce further risks of atrial fibrilation recurrences.~     However, in addition to effects on diastolic atrial function and atrial natriuretic peptide~     (ANP) secretion, this could potentially reduce stroke volume and cardiac output and may thus~     promote heart failure. Its removal could be particularly detrimental in patients with~     existing heart failure and high intraatrial pressure, as it would further promote pulmonary~     congestion and also reduce their cardiac output.~      The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac~     surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be~     prospectively included during the first 6 months following the onset of the protocol.~     Echocardiographic and invasive data will be collected simultaneously.~      The goals of the study are:~        -  To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp~          in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion~          will be measured using transesophageal echocardiography and hemodynamic measurement of~          the cardiac output.~        -  To correlate echocardiographic parameters with in situ hemodynamic data.~      A significant role of the LAA in the cardiac hemodynamic including the left ventricle~     outflow might have different clinical implications and will raise questions about:~        -  Appropriateness of LAA resection in antiarrhythmic surgery~        -  Importance of restoring sinus rhythm in atrial fibrilation patients~        -  Importance to spare LAA from ablation during atrial fibrilation ablation to avoid~          significant consequences on cardiac function.~        -  Appropriateness of the LAA occluding device in atrial fibrillation patients.~   "
18527|NCT02814838|"~     The objective of this clinical trial is to investigate whether ladarixin has sufficient~     activity (preservation of β-cell function and slow-down of the progression of T1D) to~     warrant its further development (proof of concept trial). The safety of ladarixin in the~     specific clinical setting will be also evaluated.~      The study will be a phase 2, multicentre, double-blind study. It will involve 72 patients~     with new-onset type 1 diabetes (T1D), randomly (2:1) assigned to receive either ladarixin~     treatment (400 mg b.i.d. for 3 cycles of 14 days on/14 days off - treatment group) or~     placebo (control group). Recruitment will be competitive among the study sites, until the~     planned number of patients is enrolled.~   "
18528|NCT02814825|"~     The purpose of this post-market study is to collect data on ViviGen and how its use affects~     fusion rates in the cervical spine when used as additional grafting material to fill the~     cervical spacer. The patient population of interest is patients who have already elected to~     undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.~   "
18529|NCT02814812|"~     Pancreatectomy represents the classic approach for resectable lesions of the pancreas,~     duodenum and periampullary region. Due to the technical skills required, the complex anatomy~     and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still~     considered to be at risk of postoperative complication mainly due to pancreatic juice leaks.~     Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the~     activation of pancreatic enzymes and the following infectious and hemorrhagic complications.~     Severe complications negatively affect postoperative outcomes, long-term survival, quality~     of life, and costs. Operative mortality traditionally has been defined as the rate within 30~     days or during the initial hospitalization. But in pancreatic surgery mortality rates within~     90 days after pancreatic resection are double those at 30 days. In the present study, the~     investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh~     postoperative day before discharging the patients to detect undiagnosed postoperative~     complication.~   "
18530|NCT02814799|"~     The research for a haemostasis and for an effective osseous healing are a major stake in~     oral surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during~     the haemostasis is known to reduce the risk of post-operative bruise and accelerate the~     healing but these glues present the inconvenience to be by-products of the blood, not devoid~     of infectious risk.~   "
18531|NCT02814786|"~     This research will lead to the first evaluation of intrinsic and dynamic joint and muscle~     mechanics of equinus in cerebral palsy. It would provide a direct cause and effect~     relationship between equinus and bone deformity. Mechanical insights to the pathophysiology~     of the targeted muscles will lead to better understanding and, thus, to a better medical and~     surgical management of equinus deformity. Secondary aim will provide an important insight~     whether key gait parameters can be exclusively relied upon for surgical treatment planning~     and evaluation. In a medium-term perspective, depending upon the results of this study,~     dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case~     of cerebral palsy.~   "
18569|NCT02814279|"~     The aim of this study was to compare clinical, esthetic and patient-centered outcomes of~     coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with~     connective tissue graft (CTG) in the treatment of gingival recession.~   "
18532|NCT02814773|"~     With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and~     related syndromes are a major public health issue. The lake of drug for treatment or~     preventing AD, health related quality of life (HRQoL) became an essential criterion of~     evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally~     less sensitive for a given disease. That is why other specific tools for AD have been~     developed. None of them was validated in French. The aim of this study was therefore, after~     a review of the literature, to achieve a cross-cultural adaptation and psychometric~     validation of the Quality of Life in Alzheimer's Disease (QoL-AD) and Dementia Quality of~     Life (DQoL). These two questionnaires were selected because they were the most popular in~     English- language literature for this disease.This study concerned a total of 155~     patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center.~     Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State~     Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet~     of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have~     been carried out for these two questionnaires.~   "
18533|NCT02814760|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,~     France (AVC69) (Porthault et al. 2013) the investigators observed that only a small~     percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients~     treated in one of the emergency department of the Rhone region for a suspected stroke, 84%~     of patients reached hospital through an emergency department instead of going directly to a~     stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of~     patients arrived in the emergency department too late to be thrombolysed. However, among the~     subset of ischemic stroke patients who reach emergency department less than 3 hours after~     symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis,~     only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED~     professional's knowledge and skills and to develop together efficient clinical pathway would~     decrease door-to imaging time and consequently door-to needle time and eventually improve~     overall thrombolysis rate.~      The investigators have conducted a cluster randomized controlled stepped wedge trial. All~     adult patients with suspected stroke arriving in one of the participating ED were included~     in the study along five successive four-month periods. The program featured: development of~     written materials (booklets) and video (film), and one day session of standardized training~     for trainers, at least one nurse and one physician of all EDs, with formal presentation to~     improve knowledge, and simulation to improve skills for using the FAST tool (nurses) and~     the NIHSS score (ED physicians). Additionally, a clinical pathway was developed to adapt~     general evidence based guidelines to the local organization. The primary outcome is the~     door-to imaging time.~   "
18534|NCT02814747|"~     After the use of DNA chips for diagnostic purposes, high-throughput sequencing (HTS) is~     transforming the field of developmental diseases, from fundamental research to care.~     Nonetheless, before HTS can be transferred to everyday clinical practice, in particular for~     expert diagnosis using exome HTS, it is necessary to anticipate the nature of the~     information to be given to patients and to parents in order to obtain consent for exome HTS.~      The objective in terms of public health is to allow patients with rare diseases to benefit~     from innovative technologies in optimal conditions of information and accompaniment.~      the objectives of this project are to~        1. evaluate the preferences of families of patients with development disorders as regard~          to suspicious and incidental findings from HTS before its introduction for diagnostic~          purpose,~        2. and then, following the exome analyses carried out for diagnostic purposes, describe,~          analyse and understand the experience, expectations and reactions of families and~          geneticists concerning the diagnostic trajectory in general and at the time the results~          of the HTS were announced in particular A methodology that associated quantitative and~          qualitative approaches was chosen so as to combine the advantages and overcome the~          shortcomings of each: a quantitative study to investigate a large number of patients,~          which would ensure a certain representativeness of the population and allow sub-groups~          analyses to study the upstream phase concerning indications for high-throughput~          sequencing; and a qualitative study, which though it allows only a small number of~          patients to be investigated, makes it possible to describe, analyze and understand in~          depth the complex downstream phenomena of high-throughput sequencing results~   "
18535|NCT02814734|"~     Abdominal Compartment Syndrome (ACS) is a well known condition occuring in critically ill~     patients in intensive care units.~      This syndrome features a sustained intra abdominal hypertension (IAH) above 20 mmHg and a~     multiple organ failure due to the raise of the intra abdominal pressure.~      Several reviews described CT findings linked to these conditions, but most of them suffer an~     insufficient statistical method.~      Furthermore, the main CT feature described as specific in ACS, Round Belly Sign (RBS), has~     been highly debated since.~      This study is aimed to evaluate, in a prospective way, the diagnostic and prognostic value~     of CT findings in abdominal hypertension and abdominal compartment syndrome patients hosted~     in intensive care units, based on previous reviews and adding three new CT features~     described for the first time.~   "
18536|NCT02814721|"~     Infiltrations from cannulation difficulties result in significant morbidity including loss~     of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill~     and VA characteristics. Surface marking of VA lacks real-time information and traditional~     ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic~     Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD)~     approved for VA cannulation. Study is a single center randomized, prospective pilot study~     comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard~     cannulation practices.~   "
18570|NCT02814266|"~     OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic~     measurements alone or in combination in predicting difficult intubation. The investigators~     hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are~     sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The~     investigators included the data of 170 patients (85 difficult intubation and 85 easy~     intubation) who underwent an abdominal surgery under general anesthesia. Patients in~     difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and~     gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal~     protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients.~     Anthropometric measurements were measured.~   "
18756|NCT02811939|"~     The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the~     acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will~     be tested by pretreating healthy individuals with PREG, and then assessing their responses~     to Dronabinol (THC).~   "
18537|NCT02814708|"~     Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the~     hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy.~      The aim of this study is to extend the safety and tolerability of two doses of the BioMed~     recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three~     vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and~     persistence of antibodies which produced in response to treatment with the BioMed rTSST-1~     Variant Vaccine over a period of 12 months. These antibodies are expected to be important in~     prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64~     years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the~     Department of Clinical Pharmacology of the Medical University of Vienna. The patients will~     be monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1.~     Immunization will be repeated 3 months after the first with the same dose and 6 months after~     the second immunization in the respective groups.~      Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed~     through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition~     of T cell activation (3H Thymidine incorporation; ≥ 50%).~   "
18538|NCT02814695|"~     The purpose of this study is to evaluate the efficacy of Baker's yeast extractions ,~     probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm~     motility,progressive motility and vitality as well as comparing this potency to that of~     Vitamin E in infertile men.~   "
18539|NCT02814682|"~     The purpose of this study is to elaborate a multi-dimensional indicator of the quality in~     palliative care for patients of end-of-life.~      The study will, as secondary objectives:~        -  elaborate in a standard manner one set of indicators of organization and inner working~          of a palliative care setting.~        -  compare according to these indicators, the qualities of 3 types of palliative care:~          palliative care unit in hospitals, specified identified bed for palliative care~          patients and non-specified bed.~        -  explore the relationship between organizational aspects and results in term of burden.~   "
18540|NCT02814669|"~     This study is designed to assess the safety and tolerability of atezolizumab when given in~     combination with radium-223 dichloride in participants with metastatic CRPC who have~     progressed after treatment with an androgen pathway inhibitor. An adaptive design is planned~     to first investigate the tolerability with concurrent administration (both treatments to~     begin in Cycle 1). However, if the combination is not tolerated, additional cohorts may be~     enrolled to evaluate the tolerability of radium-223 dichloride (to begin in Cycle 1) with~     delayed atezolizumab (to begin in Cycle 2 and/or 3).~   "
18541|NCT02814656|"~     AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which~     presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and~     potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The~     therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism~     bronchodilators, with an equivalent or superior safety and tolerability profile. The primary~     purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A~     multiple ascending dose (MAD) design has been selected for this study following the first~     time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in~     an ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent~     doses will be decided based on safety, tolerability and pharmacokinetic (PK) data generated~     in the previous dose. The aim of this study is to also enable further investigations in~     healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an~     acceptable side-effect profile compared to other inhaled bronchodilators on the market as a~     treatment for COPD and asthma.~   "
18542|NCT02814643|"~     This is a randomized, double-blind, parallel group, placebo-controlled study designed to~     investigate the potential effect of a fixed dose of benralizumab administered subcutaneously~     (SC) on antibody responses following seasonal influenza virus vaccination~   "
18543|NCT02814630|"~     This is a single center, non-comparative exploratory study, to investigate the effect of~     omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic~     idiopathic urticaria who had remained symptomatic despite the use of high dose~     H1-antihistamines.~   "
18544|NCT02814617|"~     The investigators performed randomized, double-blind, placebo-controlled human trial to~     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract~     (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured~     promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4,~     IL-10, IL-12, IFN-γ, TNF-α).~   "
18545|NCT02814604|"~     There is a lot of confusion when it comes to understanding nutrition information on food~     packages, thus making it difficult for consumers to choose healthy products. In today's busy~     and fast-paced shopping environment, mobile digital technology (for example, Smartphone~     applications) can help consumers make 'healthier' food choices when they are shopping. This~     study will investigate whether a traffic light front-of-pack system or an overall star~     rating system, coupled with an automated healthfulness comparison feature, on a Smartphone~     app can help consumers identify and purchase healthier foods.~   "
18546|NCT02814591|"~     In this study spatially offset Raman spectroscopy (SORS), which allows the collection of~     Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The~     principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.~   "
18547|NCT02814578|"~     The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is~     non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured~     by OCT at 1-year follow-up.~   "
18548|NCT02814565|"~     The purpose of this study is to assess the effect of cyclobenzaprine hydrochloride (HCl)~     extended release (CER) 15 mg once daily in subjects with muscle spasms associated with acute~     painful musculoskeletal conditions.~   "
18601|NCT02813863|"~     This is an open single and self-control study,planning to recruit 24 cases of healthy male~     volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples~     before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and~     Metformin.~   "
18549|NCT02814552|"~     Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure,~     kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US~     have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the~     highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged~     and other medically underserved populations are known to have the worst blood pressure (BP)~     control. Awareness of, treatment for, and control of HTN is not optimal, and varies~     according to race, whereby BP is controlled in ~53% of non-Latino Whites, 42% of non-Latino~     Blacks and only 34% of Latinos. Fundamental underlying differences in the pathophysiology~     contribute to HTN among different race groups. The United States (US) 2014 HTN~     recommendations outline race-based pharmacotherapy care for HTN. However, these~     recommendations use race-based population assumptions for Whites and Blacks only, do not~     include Latino ethnicity and have no accompanying guidelines or tools for successful~     implementation, particularly in rural primary care practices where disparate populations are~     common. Moreover, these recommendations only apply to initial therapy and lack guidance on~     subsequent regimen selection. The Optimizing Precision of HTN Care to Maximize BP Control~     Pilot (OPTI-BP Pilot), will directly address a long known and growing health disparity~     concern in the US which includes higher rates of death from CHD and stroke among Blacks and~     the poorest rates of HTN control among Latinos. Utilizing a mixed methods approach, the~     overarching goal of OPTI-BP Pilot is to test, using a pragmatic trial design, a~     personalized, algorithmic-based HTN management approach focused on age, race, biomarker~     (plasma renin activity) and treatment factors. The investigators hypothesize that~     implementation of a precision-based approach to the care of HTN in the community will~     improve BP reduction and ultimately reduce risk for CHD, stroke and death among those most~     affected by HTN.OPTI-BP Pilot is significant because it will utilize an innovative,~     systematic, precision-focused HTN management approach in an underserved, diverse population~     where BP control is currently suboptimal and lays the infrastructure groundwork for broad~     implementation across all areas of the US to minimize HTN related disparities and improve~     HTN outcomes.~   "
18550|NCT02814539|"~     The purpose of the study is to determine whether the neurodevelopmental outcome and in~     particular executive functions in 9 to 11 year old school children with congenital heart~     disease who underwent cardiopulmonary bypass surgery during their first three months of life~     is impaired in comparison to healthy children at same age. Executive functions are higher~     order cognitive functions and critical for school success.~   "
18551|NCT02814526|"~     This study evaluates the effects of physical exercise on cognition, functional status, brain~     atrophy and blood flow, and cerebrospinal fluid biomarkers of Alzheimer's disease in adults~     with a mild memory impairment.~      Half of participants will participate in a stretching-balance-range of motion exercise~     program, while the other half will participate in a moderate/high aerobic training program.~   "
18552|NCT02814513|"~     In this feasibility study, the researchers would like to investigate whether it is feasible~     to apply the ANDAGO V2.0, a new mobile robot for body-weight supported gait training~     (developed by Hocoma AG) to children and adolescents undergoing neurorehabilitation. The~     investigators will explore several outcomes and will compare some outcomes between the~     children and adolescents when they walk in the ANDAGO or with their regular walking aids.~   "
18553|NCT02814500|"~     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate~     the pharmacokinetics characteristics of DP-R212~   "
18554|NCT02814487|"~     Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for~     multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation~     is not always optimal as it can prove to be very time consuming. Moreover, it often~     constrains the range of tests used and is not a particularly good marker for patient real~     life disability status.~      A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was~     developed in order to replicate each of MSFC tests available in order to assess MS~     progression in the patient environment.~   "
18555|NCT02814474|"~     Starvation and metabolic stress increase circulating ketone bodies, potentially providing~     the heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid~     consumption. It is unclear whether this is due to inhibited peripheral lipolysis or~     diminished uptake per se.~      Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and~     fatty acid uptake.~      Methods: Randomized, single blinded, cross-over interventional study in 8 healthy~     volunteers. Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and~     18F-FDG PET/CT. Experimental elevation of circulating ketone bodies by infusion of~     β-hydroxy-β-methylbutyrate.~   "
18556|NCT02814461|"~     To determine the maximal tolerated dose (MTD) of axitinib in combination with RT for~     advanced HCC.~   "
18557|NCT02814448|"~     The purpose of this study is to test two innovative devices, the CryoPen® and~     thermocoagulator, against gas-based cryotherapy to determine whether the novel devices~     produce equivalent or improved destruction of cervical tissue compared to gas-based~     cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the~     CryoPen and gas-based cryotherapy will also be compared.~   "
18558|NCT02814435|"~     Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of~     vision cases in the UK and starts at an early age. The purpose of this observational study~     is to use the results of two questionnaires and a computerised test testing contrast~     sensitivity, to assess the impact of IRD on quality of life. This study will involve~     collecting data from patients with IRD, but also collecting data from normal controls.~   "
18559|NCT02814422|"~     Because of the rapid aging of the global population, dementia has become a serious problem,~     and Alzheimer's disease (AD) is the most common cause of dementia. AD is pathologically~     characterized by substantial neuronal loss and chronic inflammation that is associated with~     cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in~     amyloid-beta (Aβ). More recent evidence shows it is due to an increased blood-to-brain~     delivery of circulating Aβ, and significant peripheral Aβ metabolism occurs in association~     with post-prandial triglyceride-rich lipoproteins.~      In the prodromal stage of AD, patients usually suffer mild cognition impairment (MCI). The~     annual conversion rate of MCI to AD is around 10%, and within 3 years, around 30%−50% of~     these develop dementia. Brain atrophy is an irreversible brain disease that causes problems~     with cognitive and memory functions in many diseases, such as MCI and AD, etc. In order to~     allow preventive intervention for AD, MCI must be diagnosed as early as possible, using~     biomarker assays or simple imaging modality. From 2009-2013, the investigators have~     registered 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the~     investigators have also registered 8,209 cases with no evidence of AVD, but with at least 1~     cardiovascular risk factor. In this 5-year project, 300 male or female patients with stable~     symptomatic AVD over 20 years of age, and the other 600 patients with no evidence of AVD but~     with at least 1 CV risk factor, will be enrolled from our previous registry program. The~     baseline and yearly follow-up study will include clinical examination, neurocognitive~     function evaluation, and laboratory tests (TC, HDL-C, LDL-C, TG, hs-CRP, and Aβ-40, Aβ-42,~     tau protein, and other biological signatures: adiponectin, MMP-3, MMP-9, IL-6, Fibrinogen,~     Lp-PLA2, 8-Isoprostane, hFABP, sVCAM-1, sICAM-1, CA-125, MCP-1, TNF-α, cTnI, NT-proBNP, CNP,~     NGAL).~      The purposes of this 5-year project are (1) to clarify the association of triglyceride-rich~     lipoprotein and the development of dementia; (2) to validate the diagnostic power and~     prognostic implication of ultra-low-concentration biomarkers (Aβ−40, Aβ−42 and tau) for~     dementia.~   "
18561|NCT02814396|"~     Cardiovascular disease (CVD) is the leading cause of death worldwide. Most individuals with~     CVD show no evidence of disease for decades as the disease progresses before the first onset~     of symptoms, often a sudden heart attack, finally arises. The spatial repolarization~     heterogeneity within the ventricular myocardium had been proposed to represent the function~     of the heart in health and disease. Greater than normal levels of repolarization dispersion~     may allow early diagnosis of CVD. There is a growing interest in the characteristic features~     of ventricular repolarization that leads to lethal ventricular arrhythmia even with the use~     of non-antiarrhythmic drugs. The recovery time dispersion may reflect a repolarization~     heterogeneity leading to lethal ventricular arrhythmia. Previously, the investigators had~     utilized a 64-channel low-TC SQUID MCG device to develop and verify 2 parameters, so called~     smooth index of QTc (SIQTc) and T wave propagation (TWP), to accurately detect and localize~     the myocardial ischemia. Recently Nakai, et al. reported that a newly developed 187-ch~     signal-averaged vector-projected ECG (187-ch SAVP-ECG) could evaluate low-amplitude~     high-frequency potentials and repolarization heterogeneity. In this project, the~     investigators'll try to modify and improve the spatial resolution of ECG signals from a~     Self-built-in multichannel ECG system with a newly developed algorithm, and also try to~     derive the SIQTc and TWP from this system, for early detection of CVD. The investigators~     intend to prove the concept that this newly developed multichannel ECG system could~     efficiently detect or diagnose CVD with acceptable sensitivity and specificity, and in a~     portable way.~   "
18562|NCT02814383|"~     Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at~     high risk for developing brain injury in the first week of life. Intraventricular hemorrhage~     (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of~     infants. Their incidence is inversely proportional to gestational age (GA) and birth weight~     (BW). These lesions are associated with neurodevelopmental delay, poor cognitive~     performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of~     systemic hemodynamics during transition from intra- to extra-uterine life and during the~     early neonatal period is believed to be at their genesis. While the incidence of ultrasound-~     diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL~     detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal~     intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical~     complexity and brain volume and eventual neurocognitive impairment.~      Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to~     irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has~     remained relatively stable. Once translated to the bedside, the goal of this research is to~     develop a monitoring system that will allow researchers to identify infants most at risk for~     IVH and PVL and in the future, intervention studies will be initiated to use the changes in~     cerebral perfusion to direct hemodynamic management.~      The purpose of this study is to first understand the physiology of brain injury and then to~     eventually impact the outcomes in this high-risk group of infants by assessing the ability~     of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure,~     to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected~     for this study will help develop algorithms or monitoring plans that will maintain the~     appropriate brain perfusion pressure and thereby, prevent severe brain injury.~   "
18563|NCT02814357|"~     Double-blind, randomized, controlled, cross-over design with 3 test products and one control~     product.~      To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour~     15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG)~     and serum insulin levels in healthy Indian subjects, after the consumption of flat bread~     made from 100 gram of flour compositions.~   "
18564|NCT02814344|"~     The original aspect of the methodology proposed for this study concerns the use of as many~     as 16 electrodes to study the propagation and coordination (or synchronization) of uterine~     contraction. Over the last two years, the Compiègne University of Technology and the~     University of Reykjavik (Iceland) teams have developed the tools required to obtain good~     quality signals during electrohysterography and have worked on filtering and mapping of~     uterine electrical activity derived from these signals.~   "
18565|NCT02814331|"~     This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS~     electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of~     epileptogenic foci in order to perform multimodal mapping and localization of interictal~     spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG~     electrode implantation strategy prior to surgery in children with drug-refractory partial~     epilepsy.~   "
18566|NCT02814318|"~     The aim of this project is to identify the duration of vancomycin administration at which~     group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal~     mucosa. This will aid in labor management and delivery planning to ensure that the mother~     receives adequate GBS prophylaxis while also minimizing the duration of exposure to~     vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic~     workup of neonates whose mothers received vancomycin intrapartum.~      This study aims to identify the time after administration of IV vancomycin at which GBS~     colonies are 100% eradicated.~   "
18567|NCT02814305|"~     Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases~     to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse~     prescription opioids obtain these pills from friends or family members who have surplus~     medication left over from prior prescriptions. There is little published data on surplus~     opioid analgesics remaining after patients recover from painful procedures. Even less is~     known about patients' willingness to dispose of these leftover pills.~      Aims: 1) Measure the impact of a risk education intervention and a financial incentive~     intervention on patients' willingness to dispose of surplus opioids left over after~     outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused~     after outpatient dental surgery.~      Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn~     Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients~     will be randomized to a control group, an educational intervention, or a financial incentive~     intervention. The primary outcome of the trial is the proportion of patients in each arm~     that express willingness to return their unused opioids. Secondary outcomes include patient~     use of prescribed opioids and their number of unused pills. These outcomes will be measured~     using novel text-message based data collection software that patients will interact with~     using a web-enabled cellular telephone or tablet.~   "
18568|NCT02814292|"~     Validation of the PEFS to detect breast tumors will be performed by means of a prospective~     trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied~     for reproducibility and predictive ability. Data analysis will be iterative, moving on with~     each modification of the device until the final prototype is created.~   "
18571|NCT02814253|"~     This study is being done to collect information that will be used in the development of a~     new medical device. The new device is intended to help people with COPD to monitor their~     condition at home on a daily basis.~      The device used in this study is called a capnometer. Different types of capnometer have~     been in use by doctors for many years. Capnometers measure the amount of carbon dioxide in~     your breath. The device that is used in this study is called the N Tidal C. It is a small,~     battery-powered personal device for you to use indoors either at home, at work or in~     hospital.~      The study fits around the normal treatment, tests and medication of COPD patients and there~     will not be any changes made to the treatment of any study participants.~      The study lasts for six weeks. Standard care clinical assessments will be taken at the start~     of the study, after 2 weeks, 4 weeks and 6 weeks. The tests for COPD include a check-up by~     the study doctor or nurse including the usual spirometry and blood gas tests. Each~     assessment visit will last for between 15-20 minutes.~      At the start of the study each participant will be trained in the use of the device and they~     will be asked to use the device to record their normal relaxed breathing, 3 times a day~     (morning, afternoon and evening) every day for the 6- week period. A reading takes~     seventy-five seconds of ordinary breathing through the device.~      Participants who feel unwell, or have an infection, will be asked to take more frequent~     breath records of up to six times a day if possible. This would be twice in the morning,~     twice in the afternoon and twice in the evening, leaving at least an hour between readings.~      Participants will also be asked to complete a simple daily diary of how their health and~     COPD changes and information on the use of the device.~      Participants will receive a telephone call 2 weeks after their last assessment visit to~     check how they are and to ask if any of their medicines have changed.~      Participants will not benefit directly from taking part in this study and the device used in~     the study does not provide any feedback to them. The information we get from this study will~     help us to develop the device, and to learn more about the treatment and management of COPD.~   "
18572|NCT02814240|"~     The investigator put forward the hypothesis that liver fat mass in patients with pituitary~     gland failure is greater than that in a control population. Failure of the anterior~     pituitary and more particularly impaired production of growth hormone (GH) could be the~     principal mechanism responsible for increased liver fat mass in these patients.~   "
18573|NCT02814227|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an~     estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace~     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA~     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter~     OSA screening tool would allow greater screening of at-risk individuals, especially in~     underserved communities with low socioeconomic status, hopefully encouraging a greater~     proportion of such individuals to seek treatment for their condition. The specific goal of~     this project is to compare the Zansors® micro sleep sensor screening device against~     gold-standard polysomnography to establish the device's preliminary validity to screen for~     OSA accurately.~   "
18574|NCT02814214|"~     The purpose of this study is to collect simultaneous surface electrocardiogram (ECG)~     recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM)~     recordings of variations in electrical synchrony.~   "
18575|NCT02814201|"~     Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and~     Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia,~     particularly the medial globus pallidus, and the clinical expression of these two diseases~     is characterized by a combination of motor and cognitive disorders, but with two opposing~     patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and~     has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive~     origin. Far fewer studies have been conducted in Huntington's disease. However, all of these~     studies were performed with different methodologies in small cohorts and the value of the~     proposed study is to use a validated and standardized computerized mental chronometry~     paradigm, providing a better understanding of the mechanisms of action slowing in these two~     diseases and to more clearly define a disease-specific profile.~   "
18576|NCT02814188|"~     Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous~     studies to elicit a thermic effect and increase core body temperature after ingestion.~     Carbohydrate foods and supplements are commonly consumed prior to endurance running~     competition, including situations where an athlete's ability to dissipate body heat is~     compromised. Thus, there is some potential for pre-exercise carbohydrate ingestion to have a~     deleterious effect on body heat regulation in hot and humid environments. Thus, this~     projects aims to study the effects of pre-exercise carbohydrate ingestion on core body~     temperature, perceived thermal stress, and perceived exertion during high-intensity running.~   "
18577|NCT02814175|"~     An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country~     study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed~     to compare the achievement of minimal disease activity (MDA) between subjects randomized to~     either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the~     highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement~     of MDA on four different treatment regimens using adalimumab and/or MTX, with subject~     allocation based on the initial randomized treatment and achievement of MDA in Part 1, and~     with rescue treatment option.~   "
18578|NCT02814162|"~     The purpose of this study is to evaluate the predictive value of serum adiponectin levels in~     aneurysmal subarachnoid hemorrhage patients.~   "
18579|NCT02814149|"~     The aim of this prospective randomized controlled clinical trial is to compare the esthetic,~     clinical and patient-centered outcomes following immediate and early implant placement~     protocols.~   "
18580|NCT02814136|"~     Ablation of atrial fibrillation is an established method for treatment of subjects with~     atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide~     area circular ablation (WACA) is shown to provide the same results with fewer complications.~     This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects~     who are considered for ablation of atrial fibrillation.~   "
18581|NCT02814123|"~     The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor~     and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings.~     Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in~     healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of~     pramlintide with insulin at meal times improves glucose control in type 1 diabetes.~      The purpose of this study is to compare the effectiveness of 2 strategies to control your~     day-and-night glucose levels: 1) insulin-plus-placebo closed-loop delivery and 2)~     insulin-plus-pramlintide closed-loop delivery.~      The hypothesis is that a basal-bolus infusion of insulin-plus-pramlintide in the closed-loop~     system will improve blood glucose control compared to insulin-plus-placebo infusion.~   "
18602|NCT02813850|"~     The purpose of this study is to assess the efficiency of the preventive oxygen therapy on~     the occurrence of vaso-occlusive complications, which last more than 24 hours and require~     hospitalisation, in women with sickle cell disease.~   "
18582|NCT02814110|"~     Importance: Currently the gold standard treatment for ambulant patients is corticosteroids.~     Granulocyte colony-stimulating factor (G-CSF) has been reported to exert the proliferation~     of satellite cells, the regulation of myoblast proliferation, and the differentiation and~     promotion of muscle regeneration and repair.~      Objectives To evaluate the safety and efficacy of G-CSF in children and adolescents with~     muscular dystrophies Duchenne muscular dystrophy, Becker muscular dystrophy ,~     Fascioscapulohumeral dystrophy.~      Design, Setting, and Participants: Patients aged 5-15 with diagnosed muscular dystrophies~     will be included in an open study. Patients wheelchair-bound and and mobile and~     self-independent can participate in the study. Patients also treated with steroids can~     participate in this study. Clinical examination and physiotherapeutic and laboratory tests~     will be perform. G-CSF (5mcg/kg/body/d) is given subcutaneously for five consecutive days~     during the 1st, 2nd, 3rd. 6th and 12th months. Manual muscle testing (Lovett test) of the~     upper and lower extremities, isometric force with the hand dynamometer, and the 6MWT (six~     minute walk test) are measured before and after therapy.~   "
18583|NCT02814097|"~     This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with~     stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4~     weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.~   "
18584|NCT02814084|"~     The question this research project wants to explore is whether using the Prevena Incision~     Management System (Prevena) will improve sternal wound edge oxygenation in patients~     undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.~   "
18585|NCT02814071|"~     Acute pancreatitis (AP) in children has an increasing incidence and is at times associated~     with significant morbidity and mortality. Despite this, there is no high-quality~     evidence-based treatment for childhood AP and current practice is based entirely on~     historical approach and extrapolation from adult studies.~      In this study, we evaluate the use of early enteral feeding in children with AP. The~     traditional approach to treating AP relies on fasting and intravenous fluids (or~     occasionally parenteral nutrition) assuming that this minimizes stimulation of an already~     inflamed pancreas. Contrary to this, evidence exists that early feeding of patients with AP~     may be beneficial. Randomized controlled trials of fasting vs. early oral diet in adult~     patients with mild AP, showed no differences in pain, serum amylase and CRP levels, but also~     shorter hospital stay in those fed earlier. Further data in adults with severe AP~     demonstrated that early enteral nutrition was associated with decreased mortality,~     infections and multiorgan failure. These benefits were lost if enteral nutrition was~     commenced 48 hour after admission. Suggested explanations for these findings include the~     possibility that enteral nutrition may maintain integrity and function of intestinal mucosa~     and reduce gut-origin sepsis.~      Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in~     the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require~     moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data~     suggest that oral feeding with a low fat diet was as safe as NJ feeding.~      Several animal models of AP demonstrate that the exocrine pancreas is resistant to~     cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack~     of concern of exacerbating pancreatitis with enteral feeds.~      Considering this data it is less certain that diet and fat restriction contribute to~     treatment of AP. To further challenge the prior conceptions of AP management it is necessary~     to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a~     population with recognized low complication risk.~      Despite the mounting evidence to the contrary, it is still standard clinical practice to~     fast children with AP, and only slowly reintroduce feeds depending on the clinical~     improvement. This is largely due to the lack of clinical interventional studies in children~     with AP.~   "
18586|NCT02814058|"~     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of~     zolpidem hemitartarate orodispersible tablet 1.75 mg in male and female healthy volunteers.~   "
18587|NCT02814045|"~     Alzheimer's Disease (AD) is the most prevalent neurodegenerative disease, manifested as an~     initial deficit of episodic memory that evolves into a global cognitive and psychosocial~     dysfunction and which prevalence is increasing around the world. Sleep disturbance is~     frequent since early stages of the disease and sleep fragmentation had been demonstrated~     increase the production of amyloid peptide (AB) (main pathological hallmark) in non-demented~     population. Obstructive Sleep Apnea (OSA), which consist in intermittent hypoxia and sleep~     fragmentation, is a major health problem with multiple systemic effects and it's very~     prevalent in AD. However, the influence of this comorbidity on the cognitive evolution of AD~     patients remains unknown. The investigation of neurobiological markers and sleep recording~     may reveal potential mechanisms of neurodegeneration and explain the influence of sleep~     fragmentation and/or hypoxia on cognitive decline.~      To fill those gaps, investigators will perform a multidisciplinary and translational project~     to assess the progression of symptoms in AD patients, diagnosis of sleep disturbance and new~     biomarkers of progression of the disease.~      The present proposal is going to be developed by coordination of different expertises that~     will be range from the clinical research conducted by a medical neurologist, to the animal~     model and most molecular work, to be done by an experimented group in mouse work.~   "
18588|NCT02814032|"~     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has~     become the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid~     carcinoma is papillary thyroid carcinoma. Cervical lymph node metastasis is common in~     papillary thyroid carcinoma patients. This study aim to reveal protein expression~     differences between papillary thyroid carcinoma with cervical lymph node metastasis and~     without cervical lymph node metastasis.~   "
18589|NCT02814019|"~     The purpose of the study is to assess the efficacy of idebenone in delaying the loss of~     respiratory function in patients with DMD receiving concomitant glucocorticoid steroids~   "
18590|NCT02814006|"~     This study will asses the effectiveness of two strategies for timed intercourse in couples~     actively trying to conceive~   "
18591|NCT02813993|"~     Recent evidence has shown that young people that want to have children have low fertility~     knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge,~     on changes in lifestyle and on the decision to start to get pregnant.~   "
18592|NCT02813980|"~     The investigators believe epilepsy alters the way the body controls blood pressure, heart~     rate and breathing, and these changes increase the risk of sudden unexpected death in~     patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with~     these changes to the heart and blood vessels. This research study measures those differences~     which may help identify new markers to help predict those patients at greatest risk in the~     future.~   "
18593|NCT02813967|"~     This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or~     older with histologically confirmed esophageal cancer were randomly assigned to S-1~     concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall~     survival.~   "
18594|NCT02813954|"~     Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF~     pH can be affected by both maternal and fetal conditions such as preterm ruptures of~     membranes, prematurity and fetal distress. While fetal urine is the major content of AF~     since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion~     of FLL depends on chloride transport and postnatal clearance of FLL is provided by active~     reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an~     increase of pulmonary compliance accompany to pulmonary adaptation developing at the first~     hours of life. Lower genomic expression of Na channels in airways is shown to be associated~     to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF~     is thought to be relevant to fetal and maternal conditions such as gestational age,~     antenatal steroids and preterm birth, there is no study about this topic in the literature.~   "
18595|NCT02813941|"~     Background: Summary of Findings (SoF) tables have been developed to present results of~     systematic reviews in a concise and explicit format. Adopted by many review groups including~     the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the~     GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable~     judgments about the certainty of evidence and magnitude of effects. Currently, there are~     three different SoF formats in use. This study aims to compare SoF table formats in terms of~     understanding, accessibility, satisfaction, and preference with systematic review users.~      Methods: The primary objective of this three-arm randomized controlled non-inferiority trial~     is to investigate whether an alternative GRADE-SoF table, or EPC-SoF table, is noninferior~     to the current GRADE-SoF table in the understanding of information presented to systematic~     review users. Researchers, clinical practice guideline developers, policy-makers, end-users,~     or knowledge transfer will be recruited. Data will be collected electronically at baseline~     and after randomization. Noninferiority would be declared if the difference in the~     proportion of participants who understand the information displayed in the alternative SoF~     table is 10% or less.~      Discussion: This study aims to assess the understanding, accessibility, satisfaction, and~     preference between three SoF tables for displaying summary evidence from health-related~     outcomes. The results of this study will provide important knowledge to understand what~     information should be included in SoF tables in systematic reviews.~   "
18596|NCT02813928|"~     Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor~     relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses~     is based on surgical resection, when possible, chemotherapy and targeted therapies. To~     detect recurrences or metastases, a surveillance strategy is recommended for patients able~     to withstand complementary treatment during a five-year period. Over this period, the~     probability of one false-positive result is 87%. Considering that less than 10% of recurrent~     patients are suitable for potentially curative treatment and that more intensive programs~     enable an increase of the overall rate of curative resection but do not result in reduced~     mortality, less time and cost-consuming, tailored follow-up is necessary. The level of~     circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex®~     method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and~     surveillance.~      Tubes for ccfDNA analysis will be taken during medical examination at the same time of the~     CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent~     for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the~     remaining plasma will be kept in biological collection.~      Patients will have a consultation of follow-up every 3-4 months during which the dosage of~     CEA and ccfDNA will be realized as well as a medical examination, a general examination~     (weight, size, and blood pressure), an evaluation of the indices of performance status and a~     nutritional evaluation in case of loss of weight.~   "
18597|NCT02813915|"~     The investigators would like to study cardiac output, stroke volume, and fluid~     responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the~     use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides~     reliable trending of cardiac output and stroke volume. Measuring cardiac output in~     conjunction with routine monitoring will provide a better assessment of intra-operative~     status.~   "
18598|NCT02813902|"~     This proposal describes a pilot study to gather preliminary evidence of efficacy,~     tolerability and toxicity of oral PLE among a high-risk skin cancer population for the~     prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal~     methods for recruitment, intervention development, data collection, and promoting protocol~     adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as~     measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The~     investigators will also assess histologic markers of Ultra Violet (UV) damage, which have~     previously been shown to be reduced with oral PLE use in human studies, namely formation of~     UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal~     keratinocytes. Results generated from this proposal will form the foundation of a fully~     powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also~     provide information about this promising dietary supplement which may provide extra~     protection for a high-risk skin cancer population.~   "
18599|NCT02813889|"~     The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically~     hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements.~     Each toy will be equipped with sensors capable of measuring the infant's grasping actions~     such as squeezing, pinching, tilting, etc.~      A low-cost 3D motion capture system will be used to collect video data and the infants'~     reaching and body kinematics in response to the toys. A pressure mat will be used to measure~     postural changes to detect weight shifts, rolling, crawling and other movements away from~     the initial posture. By capitalizing on these wireless and low-cost technologies, it will~     permit the regular and non-invasive monitoring of infants, which can lead to detailed,~     non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators~     also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical~     developing infants. The investigators will include infants' ages 3 to 11 months who are~     categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.~   "
18600|NCT02813876|"~     Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol~     compared to standard care for recovery of patients with acute pancreatitis.~   "
18604|NCT02813824|"~     The proposed trial will evaluate the effect of aspirin 300 mg/d and 100 mg/d during 4 years~     vs placebo, in a 4 groups randomised parallel design in Lynch syndrome patients: patients~     with proven carriers of pathological mutations in mismatch repairs genes and patients with~     personal and family history characterizing Lynch syndrome according to modified Amsterdam~     criteria without proven mutation, aged more than 18 years with signed informed consent. The~     main hypothesis to be tested is that aspirin could decrease colorectal adenoma recurrence~     evaluated during high quality follow-up by colonic chromo-endoscopy in Lynch syndrome~     patients. The trial will also explore: (i) colorectal neoplasia recurrence according to~     different germline alteration in mismatch repair genes, (ii) observance to chemoprevention~     in Lynch syndrome patients, (iii) the burden of adverse events attributable to aspirin in~     Lynch syndrome patients, (iv) the dose-effect of aspirin on adenomatous polyp burden. All~     pathological samples will be reviewed using a centralized procedure. The INCA regional~     network organization and the HNPCC patient organization will allow the recruitment and the~     follow-up of a large number of patients with well characterised Lynch syndrome.~   "
18605|NCT02813811|"~     Temperature-controlled Laminar Airflow (TLA) treatment delivered by the Airsonett treatment~     device is a new treatment for patients with allergic asthma.~      The LASER Trial (temperature-controlled Laminar Airflow in Severe asthma for Exacerbation~     Reduction - LASER) is a trial, currently evaluating whether the Airsonett device is able to~     reduce the frequency of asthma attacks in patients with allergic asthma.~     (www.lasertrial.co.uk)~      Participants who successfully complete at least 6 months of follow-up in the LASER trial are~     eligible for the post trial provision of 4 years of an active TLA treatment device.~      To date there is no long term performance data available to show whether there is any~     sustained benefit from the long term use of the Airsonett device, whether any improvement in~     asthma control or quality of life is maintained and whether patients will continue to use~     the treatment device beyond 12 months (the length of the longest previous trials of TLA~     treatment.)~      The investigators plan to assess the performance of the Airsonett device by recording the~     frequency of asthma attacks in patients over a 4-year period (48 months.) The investigators~     also wish to evaluate the effect of long term TLA treatment on asthma control, quality of~     life, healthcare resource use and patient acceptability of longer term use of the Airsonett~     device.~      Participants will be sent and asked to complete a series of questionnaires on a 6 monthly~     basis over the 48 month study period. Questionnaires will be returned by post to a single~     study centre based in Portsmouth, UK. Participants will also be contacted by telephone on a~     6 monthly basis by a member of the trial team to collect information about their medication,~     healthcare resource use and whether they have had any asthma attacks since their last~     contact.~      Participants will not be expected to visit the study centre during the trial.~   "
18606|NCT02813798|"~     The purpose of this study is to determine the effect of renal impairment on rivipansel.~   "
18607|NCT02813785|"~     This Phase III, multicenter, open-label, randomized, controlled study is designed to~     evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody~     atezolizumab compared with docetaxel in participants with locally advanced or metastatic~     NSCLC who have progressed during or following a platinum-containing regimen. Treatment may~     continue until disease progression or unacceptable toxicity.~   "
18608|NCT02813772|"~     Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of~     life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The~     variability in the prevalence of IC reported by the several studies depends on different~     criteria used to define IC.The etiology of IC remains still unclear. Recently, the~     composition of intestinal microbiome has been addressed as an independent risk factor for~     IC. There are no uniform criteria for a specific therapeutic approach of IC. Based on these~     conclusions the objectives of our study are: to determine whether the administration of a~     partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri,~     is beneficial in IC in reducing the infant crying duration and in prolonging the duration of~     sleeping period~   "
18609|NCT02813759|"~     To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC)~     available on the glycemic response, postprandial C peptide and satiety in patients with type~     2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).~   "
18610|NCT02813746|"~     The aim of this study is to understand the epigenetic and transcriptomic mechanisms that~     regulate the fetal origin of adult diseases (FOAD), either for the presence of metabolic~     disorders in the future mothers, such as obesity or for the exposure to certain contaminants~     such as tobacco.~      To do that, the miRNAs profiles secreted to the endometrial fluid in obese women vs~     normoweight women during the window of implantation will be identified. Likewise, it will be~     studied how that miRNA signature is normalized once a substantial loss of weight is produced~     by the patients involved in the studied. In parallel, a comparison of the miRNA expression~     profiles secreted in the endometrial fluid in smoker women vs nonsmoker women will be~     performed. As in the previous case, it will be studied if after the exposure to these~     contaminant, the normalization of the miRNA expression signature occurs. Finally, an in~     silico analysis will be carried out in order to define the target genes and the metabolic~     pathways affected by the miRNAs profile secreted in both pathological conditions~   "
18611|NCT02813733|"~     In a large prospective cross-sectional study, the investigators aimed to identify the~     determinants of thyroid surgery outcomes and quantify the relative influence of preoperative~     and intraoperative factors. For this purpose, the investigators considered the interplay of~     several characteristics specific to surgeons, patients, and surgical procedures.~   "
18612|NCT02813720|"~     Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA).~     Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA~     is significantly higher in patients with nail involvement (OR = 2.24; 95% CI [1.26-3.98]).~     The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95%~     CI [1.34-5.85]).~      Thus the investigators wanted to test the hypothesis that onycholysis, in patients without~     PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of~     bone micro-structural alterations.~      Patients and Methods~      The investigators will recruit 4 groups of subjects:~        1. Patients with peripheral PsA,~        2. Patients with psoriatic nail onycholysis,~        3. Patients with PsO only~        4. Healthy match control subjects. The investigators will assess the presence of~          enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all~          subjects at baseline and 4 years.~   "
18674|NCT02812914|"~     Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral~     strategies to the millions of households worldwide that continue to burn solid cooking fuels~     using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and~     pneumonia, are associated with high exposures to household air pollution during pregnancy~     and early infancy. The proposed study will assess the feasibility and acceptability of an~     introduced liquid petroleum gas stove, complemented by two alternative approaches to~     delivering tailored behavioral change interventions, among pregnant women and their~     neonates.~   "
18613|NCT02813707|"~     The World Health Organization (WHO) statistics, in 2008, there were more than 1.4 billion~     adults, aged 20 and older, and were overweight. Of these over 200 million men and nearly 300~     million women are obese. Body Mass Index (BMI) more than 30 is considered as obese and~     increasingly bariatric surgery is the commonest way used nowadays to lose weight. Moreover,~     surgery will influence many other health factors and parameters. Many studies prove the~     improvement of metabolic and psychological status of patients post bariatric surgery. In~     addition, many vitamins will be affected and should be replaced. This research study is~     continuation (PART 2) of previously approved study (approval: 13/54). Brief findings of the~     study are attached. Our aim in this part of the study to assess long term the impact of~     bariatric surgery on metabolic, nutritional and quality of life status on patients post~     bariatric procedure of at least 12 months post-surgery follow up. As we noted in our~     previous initial study that there is significant loss the collection of the data due to no~     show for proper follow up routine care. Previously it was approved to consent patients by~     phone calls and extract information regarding Quality of Life (QoL) post-surgery. This will~     be replaced by seeing the patients in the outpatient clinic and providing the necessary~     information and consent.~   "
18614|NCT02813694|"~     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the~     treatment of adults with moderate community-acquired bacterial pneumonia~   "
18615|NCT02813681|"~     Historically, women who have chronic back pain after pregnancy have attributed the cause to~     the epidural procedure. While many studies have shown no greater incidence of generalized~     post-partum back pain in those who received an epidural, no studies have measured localized~     pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might~     limit patient's mobility and activities in the post-partum period. Understanding the factors~     that increase insertion site pressure sensitivity will allow the investigators to modify~     epidural placement technique in order to minimize this effect.~   "
18616|NCT02813668|"~     This study will test the implementation, effectiveness, cost-effectiveness, and~     acceptability of a worksite lifestyle improvement program that includes lifestyle education~     classes led by trained individuals from the worksite and improvements in the worksite~     environment that will make it easier for employees at risk for diabetes or with unmedicated~     diabetes to lose weight, exercise more, and eat a healthier diet. A total of 2000~     participants across 8 worksites in India (4 from Delhi and national capital region [NCR]~     region and 4 from Chennai) will be involved in this study for 5 years.~   "
18617|NCT02813655|"~     The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in~     the treatment of post-dural puncture syndrome in patients receiving epidural analgesia or~     combined spinal-epidural analgesia for labour.~   "
18618|NCT02813642|"~     To evaluate the relationships between bone mineral markers levels at dialysis start and~     vascular calcification progression during a 2 year follow up~   "
18619|NCT02813629|"~     The aim of this study is verify if the use of Transcranial Direct Current Stimulation (tDCS)~     associated to peripheral electrical stimulation (PES) has an analgesic effect in individuals~     with Sickle Cell Disease (SCD). The association between tDCS and PES may have additive~     effects in pain control, and should be an alternative for pain control in patients with SCD.~     This technique is safe and inexpensive, being able to contribute to the control of symptoms~     and improve quality of life of these individuals. Its effects may decrease pain intensity~     and / or increase of the period between episodes of acute pain. It may also affect pain~     modulatory pathways in the brain interfering with thalamocortical dysthymia, a phenomenon~     associated with decreased modulation of the thalamus by the primary motor cortex.~   "
18620|NCT02813616|"~     Chronic constipation (CC) and Irritable Bowel Syndrome with Constipation (IBS-C) are two~     conditions difficult to manage because factors affecting dissatisfaction to treatments are~     misleading. This observational multicentric national study is aimed to assess which factors~     are related with a clinically significant improvement in patients with CC and IBS-C.~     Patients will be evaluated at baseline and after every one-month standard of care therapy~     with standardised questionnaires to assess bowel habit and satisfaction to treatments.~     Somatisation, quality of life, colonic transit time and resting anal pressure will be~     assessed at baseline.~   "
18621|NCT02813603|"~     Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA~     concerning the diagnostic yield, the quality and quantity of each biopsy needle without~     raising the rate of complications.~   "
18622|NCT02813590|"~     Ascitic fluid microbiome is going to be investigated in this study by using internal~     transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and~     sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of~     spontaneous bacterial peritonitis (SBP).~      All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis~     are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps~     from puncture side and stool samples as well as conventional culture methods are performed~     to investigate the difference in the microbiome between patients with and without SBP.~   "
18623|NCT02813577|"~     The post approval study will enroll US female patients presenting with claudication or~     ischemic rest pain and an angiographically significant lesion in the superficial femoral or~     popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix~     Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two~     (2) years.~   "
18644|NCT02813304|"~     The primary objective of this study is to compare the short-term effectiveness (2 and 6~     weeks following the start of the rehabilitation program), in terms of symptoms and~     functional limitations, of a rehabilitation program centered on gradual reloading to a~     rehabilitation program centered on rest and cryotherapy in individuals with acute rotator~     cuff tendinopathy. The secondary objective is to explore the effects of these programs on~     shoulder control (acromiohumeral distance), subacromial structures (supraspinatus tendon~     thickness) and central pain modulation. The hypothesis is that the rehabilitation program~     centered on gradual reloading will lead to a faster improvement at week 2 and 6 when~     compared to the program centered on rest and cryotherapy.~   "
18757|NCT02811926|"~     The purpose of this study is to use routinely-collected health data from registers to~     examine the incidence of parastomal bulging (PB) at different time points in the first year~     after surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk~     factors for development of PB.~   "
18624|NCT02813564|"~     Plasticity refers to susceptibility of an organism to change. Cognitive training is an~     intervention approach based on the notion of plasticity. It entails the repeated exercise of~     a set of higher-order cognitive abilities over several weeks after which performance gains~     are expected on the trained as well as untrained tasks. Cognitive training has produced~     successful results in various clinical groups, but its benefits have not been explored in~     Autism Spectrum Disorder (ASD). The present study will develop a software-based training~     program tailored to the cognitive deficits in ASD. The investigators will also examine~     possible training-induced functional changes within the brain using functional Magnetic~     Resonance Imaging (fMRI). Fifty children with ASD 3-7 years will be recruited and randomly~     assigned to the control (n=25) or the training group (n=25). A subgroup of these samples~     will carry out the response inhibition and set-shifting tasks in the fMRI scanner. The study~     will consist of a pre-post design and a four-month follow up. Repeated measures Analysis of~     Variance (ANOVA) will be carried out with group (training, control) as the between subjects~     factor and Time (pre- post-training, follow-up) as the within subjects factor to identify~     training induced cognitive improvements. To determine training-induced biological changes~     within the brain, activity maps associated with response inhibition and set-shifting at~     pre-training and post-training sessions will be entered into a group ANOVA and contrasted~     for differences within- and between groups.~   "
18625|NCT02813551|"~     Currently there is no intervention to prevent persistent postpartum hypertension in~     preeclamptic women. Physiologically, the use of a pharmacokinetically predictable~     loop-diuretic is a reasonable intervention to increase elimination of extra fluid~     accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide~     reduces the incidence of persistent postpartum hypertension in preeclamptic women.~   "
18626|NCT02813538|"~     The aim of this study is to evaluate early clotting disorders through thromboelastogram and~     anticoagulant proteins levels (maybe also endothelial markers) and liver function by~     indocyanine green clearance after major liver resection and search for a potential~     relationship between them.~   "
18627|NCT02813525|"~     Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function~     and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI)~     has previously been described in a population of normal fetuses. Fetuses with IUGR, the~     velocities recorded in the aortic isthmus could be affected and the normal development of~     the ISI should be changed, because of the increase in placental resistance on one hand, and~     the gradual deterioration ventricular functions on the other one. Investigators hypothesize~     that the ISI index in the context of placental insufficiency could provide additional~     arguments on the extraction timing, the prognosis and the fetal extraction mode to severe~     hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the~     feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by~     Doppler systolic isthmus and the calculation of the ISI index.~   "
18628|NCT02813512|"~     The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue~     Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant~     autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects~     who have chronic non-hemorrhagic stroke (>6 months).~   "
18629|NCT02813499|"~     Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a~     challenge for the emergency physician. The management of a suspected ACS is well codified,~     based on troponin assays, renewed if necessary.~      Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the~     Emergency department are unclear. The fear is, firstly, to miss a potentially life treating~     diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of~     highly sensitive troponin assays also increases the risk of over-investigation by a larger~     number of elevations of the biomarker in non-coronary circumstances leading to a~     prolongation of hospitalization and, possibly, unnecessary treatments and invasive~     investigations.~      CARE rule could help to streamline this first step. It is established by assigning a value~     from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for~     an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a~     troponin should be performed if the sum is > 1 (positive rule).~      Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing~     for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding~     ACS with a risk of false negatives <2%. A negative CARE rule always corresponds to a HEART~     score ≤3.~      Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in~     chest pain as an observational European multicenter prospective study.~   "
18630|NCT02813486|"~     The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of~     a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of~     age.~   "
18631|NCT02813473|"~     The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates~     the use of CT scan and angiogram of the heart to help doctors decide which method is the~     best to improve blood supply to the heart in patients with complex coronary artery disease.~     Each patient will undergo an angiogram and CT scan per standard of care. The randomization~     strategy in this study is not between patients but between two teams of doctors, the~     so-called Heart Teams, will be randomized: in the first round, team 1 assesses the~     angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment~     would be the best to treat complex coronary artery disease. In the second round, both teams~     see the imaging method that they did not see in the first round, and make the decision~     again. The final decision on the clinical treatment strategy is at the sole discretion of~     the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading~     influencing this final decision.~      Hypothesis: Determination of the best treatment strategy for coronary artery disease based~     on a CT scan will result in similar decisions as based on invasive coronary angiography.~   "
18632|NCT02813460|"~     The purpose of this study is to evaluate in a double-blinded fashion the taste and overall~     acceptability profile of different ALS-008176 oral liquid formulations as compared to the~     reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension~     without sweetener/flavor) for pediatric clinical development and commercialization.~   "
27732|NCT02694146|"~     To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with~     coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with~     hyaluronic acid (Hylan G-F 20).~   "
18633|NCT02813447|"~     Objective: Determine whether treatment of perceived stress, anxiety, and depression with~     anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of~     life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) undergoing~     pulmonary rehab.~      The study is a prospective, randomized, double-blinded, placebo-controlled study to assess~     the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD patients undergoing pulmonary~     rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and have mild to moderate~     major depression according to the DIS and HRDS criteria will be recruited from Duke~     Pulmonary Rehab.~      Multivariable regression models will be constructed to evaluate the relationship between~     perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and~     GOLD score. A multivariable regression model will be constructed to assess whether treatment~     of perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an~     effect modifier on 6MW distance and dyspnea scores in patients with COPD who are enrolled in~     pulmonary rehab.~      Descriptive statistics will be used to examine the socio-demographic characteristic data.~     Student t-tests will be performed to assess group differences in continuous data.~     Categorical variables will be examined using the Pearson's Chi-Squared test.~   "
18634|NCT02813434|"~     This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45)~     for the etiological diagnosis of poststroke cognitive impairment and dementia. This study~     stems from two converging objectives: (1) the need to refine characteristics of vascular~     cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI~     and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve~     the etiological diagnosis of poststroke cognitive impairment and dementia. It will take~     advantage from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months~     poststroke in consecutive patients according to a standardized international battery)~     coordinated by the Amiens University Hospital center, the opportunity to perform amyloid~     imaging in vivo using Positron Emission Tomography (PET) and Florbetapir (a production site~     is located in the city of Amiens) and the collaboration between neurology and imaging~     departments of Amiens University hospital.~   "
18635|NCT02813421|"~     The purpose of the study is to learn more about blood glucose control when people with Type~     1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a~     continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to~     stable blood glucoses and less frequent insulin pump dose changes during the transition to~     an insulin pump.~   "
18636|NCT02813408|"~     The purpose of this observational study of metastatic castration-resistant prostate cancer~     (mCRPC) participants is to explore whether or not there are differences between participants~     treated with abiraterone acetate and enzalutamide on the health-related quality of life~     (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).~   "
18637|NCT02813395|"~     Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on~     neuromuscular performance in healthy subjects after an induced muscle fatigue protocol.~     Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a~     preliminary evaluation using surface electromyography and isokinetic dynamometer of the~     flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was~     control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately~     after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions~     at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser~     therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after~     interventions.~   "
18638|NCT02813382|"~     Considering fast-track principles, an ideal spinal anesthetic should have minimal~     complications and above all fast recovery so reducing in-hospital stay.~      Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with~     an umbilical or unilateral inguinal hernia and no contra-indications for surgery were~     included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric~     2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg).~     Motor block was assessed using the Bromage scale. Sensory block was measured by determining~     the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of~     sensory and motor block, time to void and home readiness were defined as clinical endpoints.~   "
18639|NCT02813369|"~     AstraZeneca agreed to conduct this post-authorization observational safety study (PASS) to~     monitor clinically important identified and potential risks within a cohort of patients~     treated with naloxegol, including the occurrence of bowel perforation, acute myocardial~     infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality,~     hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain~     severity. This study is part of a broader post-marketing commitment to augment routine~     evaluation of the safety profile of naloxegol in clinical practice~   "
18640|NCT02813356|"~     The overall research goal for this study is to provide additional data to characterize the~     safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of~     cancer and who are treated with opioids chronically.~   "
18641|NCT02813343|"~     This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its~     implementation in 3 hospital/health system sites across Ontario. The 6 month study includes~     300 participants that are randomized to an immediate treatment group or a delayed~     intervention group. The primary outcomes include changes in HbA1c and patient reported~     outcomes and experience measures. Qualitative interviews with various stakeholders will~     explore issues relating to successful implementation.~   "
18642|NCT02813330|"~     To compare the effect of subcutenous sterile water injection technique with the subcutaneous~     saline injection technique in the degree and duration of low back pain-relieving during~     childbirth~   "
18643|NCT02813317|"~     This prospective, multicenter, observational study aims to explore a comprehensive approach~     to the care of early breast cancer patients in a regional health territory (including 1.5~     million women and characterized by a breast cancer incidence and mortality higher than~     national ranges), incorporating all healthcare actors inside and outside the hospital.~   "
18672|NCT02812940|"~     A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for~     Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after~     allogeneic hematopoietic stem cell transplantation in patients with haematological~     malignancies~   "
18645|NCT02813291|"~     The mental repetition of movements - or motor imagery (MI) practice - facilitates motor~     learning. It allows avoiding fatigue that occurs during physical practice; this method is~     thus particularly interesting for elderly people. Transcranial direct current stimulation~     (tDCS) is a noninvasive method of neurostimulation during which a low direct current is~     applied to the brain via electrodes placed on the scalp. This method has been successfully~     used to enhance motor learning in both young and elderly subjects.~      The main aim of this study is to assess the impact of MI practice combined with tDCS on the~     learning of a complex finger sequence, in young and elderly subjects.~      For that purpose, young and elderly healthy subjects will be randomly assigned to~     Stimulation and Sham groups. There will thus be a total of four groups: Young Stim, Young~     Sham, Elderly Stim, and Elderly Sham.~      All subjects will participate to three training sessions spread over five days, and a~     retention test one week after the third training session.~      During training they will mentally repeat a complex finger sequence with the left hand, for~     13 min:~        -  Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in~          parallel an anodal tDCS of the primary motor cortex.~        -  Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a~          sham tDCS of the primary motor cortex.~      Immediately before (pretest) and after (posttest) each training session, as well as during~     the retention test, subjects will repeat the sequence as many times of possible, for 1 min.~     During these tests (pretests, posttests and retention test) electroencephalographic activity~     will be recorded to assess the Mu rhythm power.~   "
18646|NCT02813278|"~     Colorectal cancer resection is one of the most common types of abdominal surgery. Though~     most patients undergoing colorectal resection show recovery of bowel movements within a~     week, some have prolonged intestinal paralysis or postoperative ileus, resulting in~     decreasing patient comfort, increasing morbidity and mortality, a longer hospital stay and~     subsequent increased healthcare costs.~   "
18647|NCT02813265|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
18648|NCT02813252|"~     This study will provide long-term follow-up for patients who have received treatment with~     JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15~     years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of~     persisting JCAR015 vector sequences, and survival.~   "
18649|NCT02813239|"~     In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients~     present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In~     vitro oocyte maturation is still an experimental technique, with poorer results than~     conventional IVF. For that reason improve in in vivo maturation could have a better impact~     on reproductive outcome.~   "
18650|NCT02813226|"~     In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC)~     planned to have hormonal treatment, will undergo conventional imaging and functional imaging~     prior to treatment and post treatment to determine if changes in imaging results will be~     prognostic of outcome. Patients will have a clinical follow-up every 3 months post~     randomization for one year and followed for survival at Years 2 and 3.~   "
18651|NCT02813213|"~     This is a double-blind randomized controlled clinical trial, that compares the percentage of~     epithelialization of skin defects using the conventional meshed split thickness skin grafts~     vs skin micro grafts.~      Two techniques will be applied in the same patient. The skin defect will be divided in two~     parts, and with a randomized method each half of this defect will be assigned to one of the~     two techniques.~   "
18652|NCT02813200|"~     Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the~     world and further increase in its prevalence and mortality has been predicted. Currently,~     the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol~     and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:~        -  long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),~        -  long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).~      These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®,~     Handihaler® and Diskus®.~   "
18653|NCT02813187|"~     This is an observational, longitudinal real world registry of venous leg ulcers created from~     electronic health record data obtained in the course of clinical care. Data from certified~     electronic health records transmit data as part of the requirement to share data with a~     specialty registry under Objective 10 of Meaningful Use of an EHR.~   "
18654|NCT02813174|"~     The primary aim of this study is to assess the relationship between personality style,~     self-compassion and depression during pregnancy, to identify psychological risk factors,~     particularly personality styles, that may contribute to the onset of PPD. Additionally, the~     study will provide support for the effectiveness of Internet-based Compassionate-Mind~     Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in~     the 2nd and 3rd trimester of pregnancy. The study will also assess differences along~     personality predictors and depression severity as they relate to intervention outcomes (i.e.~     depression in postpartum and self-compassion) and engagement. The researchers hypothesize~     that women both at high and low risk for PPD will receive benefits from the intervention,~     however, those who endorse more maladaptive personality traits will likely engage and~     benefit less than those who do not endorse these traits.~   "
18655|NCT02813161|"~     This is an observational, longitudinal real world registry of diabetic foot ulcers created~     from electronic health record data obtained in the course of clinical care. Data from~     certified electronic health records transmit data as part of the requirement to share data~     with a specialty registry under Objective 10 of Meaningful Use of an EHR.~   "
18656|NCT02813148|"~     AZ agreed to conduct this post-authorization observational safety study to determine the~     characteristics of patients prescribed naloxegol at time of first prescription and treatment~     patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany~   "
19195|NCT02805998|"~     The overarching goal is to utilize a randomized control design to examine efficacy of~     web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment~     as usual alone for insomnia and depression outcomes among pregnant women with insomnia at~     high risk for depressive relapse/recurrence (n=208).~   "
18657|NCT02813135|"~     The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger~     2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations~     in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to~     enrich clinical trials of molecularly targeted agents and possibly improve outcomes in~     specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The~     diversity and heterogeneity of the detected molecular alterations and the low number of~     pediatric patients mandate an adapted, innovative trial design for the attributed treatment~     options in order to satisfy the current unmet medical need.~      This basket trial is designed to cover the targeting of several survival pathways in~     oncogenesis that are currently not adequately employed for pediatric patients in Europe.~   "
18658|NCT02813122|"~     examination of the importance of the use of X-ray in bariatric surgery outcome.~   "
18659|NCT02813109|"~     The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr)~     levels in infants are unreliable as a detector of renal function in the first few days of~     life because they may continue to reflect maternal levels. Although few candidates appear to~     be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm~     infants exist, and studies have yielded conflicting results. Therefore, we aimed to~     determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.~   "
18660|NCT02813096|"~     This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to~     prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor~     thrombus following curative resection~   "
18661|NCT02813083|"~     This study will help the investigators design a method to detect the disease-causing immune~     cells in patients with rheumatoid arthritis (RA). Such methods are not currently available,~     but if successful, would help scientists to better understand the causes of RA.~   "
18662|NCT02813070|"~     This was a Phase 2, multicenter study to assess the extent and patterns of [18F]flutemetamol~     uptake in the brains of 3 groups of Japanese subjects: HV, aMCI, and pAD, and to assess the~     reproducibility of brain uptake and of image interpretation. Subjects underwent open-label~     intravenous (i.v.) administration of Flutemetamol F 18 Injection and PET imaging of the~     brain. Blinded visual image reads were performed by 10 independent board-certified readers~     (5 Japanese and 5 non-Japanese) with nuclear medicine image interpretation experience. The~     blinded visual assessments were compared with the subject's clinical diagnoses, and the~     agreement between the image interpretations made by the 2 groups of readers (Japanese and~     non-Japanese) was determined.~   "
18663|NCT02813057|"~     Comparison of physical activity parameters of the lower extremity muscles in patients who~     received total extraperitoneal repair (TEP) and STOPPA repair.~   "
18664|NCT02813044|"~     A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus~     inhalational anesthesia on perioperative period during transsphenoidal surgery. However,~     they have limitations especially for the phase of recovery after anesthesia: a fragmentary~     assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed~     to assess the degree of recovery, specially after anesthesia and surgery. In this study, the~     investigators aim to compare the quality of recovery after inhalational anesthesia and after~     TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for~     pituitary tumor under general anesthesia.~   "
18665|NCT02813031|"~     Nutritional clinical trial to evaluate the effectiveness of different functional meat~     products on the nutritional status of healthy people~   "
18666|NCT02813018|"~     Management of postoperative pain is critical in the pediatric patients, however, safe and~     effective analgesia for pediatric surgical patients remains a challenge. Preemptive~     analgesia is based on preventing a prolonged change in central nervous system function by~     blocking afferent input before the surgical stimulation may evoke central sensitization and~     aggravate amplification and prolongation of postoperative pain. However, the clinical~     efficacy of preemptive analgesia is still controversial. In this study, the investigators~     aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric~     patients for corrective osteotomy of the lower extremities expecting severe postoperative~     pain.~   "
18667|NCT02813005|"~     Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during~     general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.~      The investigators hypothesis that procedure is shorter and more accurate in High Frequency~     Jet Ventilation group reducing target movement induced by ventilation.~   "
18668|NCT02812992|"~     The hypothesis of the proposed study is that individualized assessment directed treatment~     algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine~     therapy. The project uses a CGA, which includes various tests and scoring systems, to~     stratify patients as GO-GO, SLOW-GO or FRAIL patients. Depending on test results~     patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group:~     gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of~     chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign~     patients to their definite treatment arm. The primary objective is that CGA-stratified~     patients do not decline in their CGA performance in response to chemotherapy measured as a~     loss of five points or less in the Barthel`s ADL (ADL1 vs. ADL2 during core CGA assessment).~   "
18669|NCT02812979|"~     The principal objective is to show noninferiority of nebulized salbutamol through the high~     flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction~     compared to nebulization by the usual method (spray mask).~   "
18670|NCT02812966|"~     Investigators hypothesize in patients presenting with significant peripheral arterial~     disease with clinical indications for treatment with angioplasty, there will be a difference~     in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter~     and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.~   "
18671|NCT02812953|"~     A sample of plasma and whole blood will be obtained at 3 time points (pre-procedural, early~     post-procedural and at hospital discharge). Test for platelet reactivity (LTA, light~     transmittance aggregometry and Elisa PRI, Platelet reactivity index) and for multimeric VWF~     (von Willebrand factor) analyses will be performed at the time of blood sampling. Aliquots~     of plasma will be stored and frozen for further analyses~   "
18676|NCT02812888|"~     Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low~     high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used~     worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts~     on various levels of these components.~      Recent evidence from HepG2 cells indicates that betatrophin, also known as~     TD26/RIFL/lipasin/ANGPTL8/C19orf80, a secreted protein that regulates glucose, lipid~     metabolism, and energy homeostasis, is induced by T3. However, the role of betatrophin in~     hyperthyroid patients is unknown.~      The objective was to study serum betatrophin levels in hyperthyroid patients and the~     association of serum betatrophin levels with hyperthyroidism.~   "
18677|NCT02812875|"~     CA-170 is a rationally designed and orally available, small molecule that directly targets~     the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell~     activation (VISTA) immune checkpoints and results in activation of T cell proliferation and~     cytokine production. This is a multi-center, open-label, Phase 1 trial of orally~     administered CA-170 in adult patients with advanced solid tumors or lymphomas who have~     progressed or are non-responsive to available therapies and for which no standard therapy~     exists.~   "
18678|NCT02812862|"~     The aim of this study is to evaluate the pulmonary and cardiac effects of a LABA / LAMA~     combination therapy in patients suffering from both chronic heart failure and chronic~     obstructive pulmonary disease.~      The secondary aim of the study it to assess the safety of the LABA / LAMA combination.~   "
18679|NCT02812849|"~     The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for~     diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.~   "
18680|NCT02812836|"~     Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that~     measures pressures along the anal canal in a very detailed manner. It provides complete data~     about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon~     expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet~     obstruction.~      Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find~     the correlation between this diagnostic equipment.~   "
18681|NCT02812823|"~     Pressures measured by manometric solid-state catheters may differ according to the type of~     the catheter and specific anatomy and physiology of anorectum.~      The aim of the study is to establish the difference in recordings between 2 types of~     anorectal catheters used in pediatric patients and to validate the most appropriate way to~     diagnose of functional disorders.~   "
18682|NCT02812810|"~     The fight against smoking is a public health priority. Without help, fewer than 5% of des~     smokers are abstinent at 12 months after smoking cessation.~      Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of~     success at 12 months in patients dependent on nicotine is only 18%. Moreover, other~     therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.~      The investigators propose a new therapeutic strategy for smoking cessation, which is based~     on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine)~     with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to~     diminish craving for tobacco). The principal objective is to improve the success rate for~     smoking cessation attempts in patients who are highly dependent on nicotine, and who have~     failed using usual smoking cessation strategies.~   "
18683|NCT02812797|"~     The purpose of this study is to determine whether expressions of adipokines can provide~     prognostic information concerning patients with chronic heart failure.~   "
18684|NCT02812784|"~     Patients with septic shock in the intensive care unit have an elevated risk of developing~     acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that~     limit the worsening of renal function might have an impact on the mortality rate in these~     patients. Given the absence of validated pharmacological treatments for limiting the~     progression of AKI or for accelerating recovery from AKI, early intervention and the~     restoration of the glomerular filtration rate (GFR) in this context of hemodynamic change~     during the initial phase of septic shock might improve the patients' prognosis. One major~     challenge is therefore how to determine whether or not the AKI is reversible. The~     best-studied biomarkers (NGAL and KIM 1) have little discriminant power in septic patients~     because of their poor specificity or unsuitable kinetics for very early diagnosis. The~     combination of urine assays for tissue inhibitor of metalloproteinase 2 (TIMP2) and~     insulin-like growth factor binding protein 7 (IGFBP7) has shown good diagnostic performance~     for the very early detection of the risk of developing AKI in the following 12 hrs. Urine~     levels of these two markers specifically reflect damage to kidney tubules. Moreover, the~     levels appear to be strongly correlated with the severity of tubule damage. Thus, one can~     reasonably hypothesize that measurement of these markers in the very early stages of septic~     shock might determine the presence and severity of kidney tubule damage. A threshold (yet to~     be defined) would help to differentiate between (i) transient, non-severe injury and (ii)~     injury that is already too severe to be reversible.~   "
18685|NCT02812771|"~     Safety and PK of a once daily topical application of efinaconazole in the treatment of~     pediatric subjects with mild to severe onychomycosis of the toenails.~   "
18686|NCT02812758|"~     Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse~     pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly~     predictive of the response to vascular filling in sedated, mechanically ventilated patients.~     However, the influence of the sedation depth on these dynamic indices has never been~     evaluated.~   "
18687|NCT02812745|"~     Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be~     justified by the agreement between various clinical situations in which BIS monitoring~     appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death~     , and the diagnosis of amniotic fluid embolism. The current controversy concerning the~     triple low state reinforces the need for an accurate study in this field. Furthermore, the~     recent review by Bidd argues in this sense.~   "
18897|NCT02809937|"~     Delirium is a frequent postoperative complication. Its occurrence is associated with worse~     long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose~     dexmedetomidine infusion during the early postoperative period decreased the incidence of~     delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to~     evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year~     outcome in elderly patients recruited in the previous randomized controlled trial.~   "
18688|NCT02812732|"~     After completing over 600 interviews with parents, adolescents, and clinicians to determine~     reasons why HPV vaccines are used or not used, the investigators recently piloted a~     communication-based educational intervention with healthcare clinicians to improve~     communication around HPV vaccination. The intervention combined education and quality~     improvement methods using a mechanism called Performance Improvement Continuing Medical~     Education. This type of intervention is attractive to clinicians because they improve their~     cancer prevention practices while fulfilling requirements for maintaining board~     certification. The intervention consists of seven education and feedback sessions along with~     baseline and follow-up chart reviews and facilitated group discussions of clinician and~     practice vaccination rates. The pilot intervention was effective: at the two pilot~     intervention sites, girls were 60% and boys were 15 times more likely to receive HPV~     vaccination than at control sites both during and after the intervention period.~      The goal of the proposed research is to broadly test the intervention's effectiveness in a~     diverse group of pediatric and family medicine practices serving low-income and minority~     patients. First, the investigators will perform a randomized trial in five community health~     centers to determine the effectiveness of the intervention. Second, the investigators will~     examine what made the intervention successful and identify barriers to sustainability with~     the goal of ensuring that the intervention can be successfully replicated in other settings.~     Third, the investigators will explore the effects of the intervention on parent-clinician~     communication by surveying parents and clinicians and observing clinical encounters when~     vaccination is discussed.~      The proposed intervention represents an innovative and scalable model for promoting cancer~     prevention and screening activities by clinicians. Unlike programs that increase~     administrative burdens on busy clinicians, the proposed intervention allows clinicians to~     improve cancer prevention practices while simultaneously fulfilling requirements to maintain~     their board certification and improving the quality of cancer prevention care. It therefore~     has great potential for widespread dissemination.~   "
18689|NCT02812719|"~     Melasma is an acquired form of hyperpigmentation that is seen most commonly on the face,~     characterized by symmetrically distributed brown patches of variable darkness. The~     cosmetically unattractive nature of this disorder has been shown to negatively affect a~     patient's quality of life. Unfortunately, the treatment of melasma is challenging and often~     disappointing. Treatment includes a combination approach with strict sun protection,~     cosmetic camouflage, topical lightening agents, laser therapy, and chemical peels.~      Today, the investigators define chemical peeling as the application of chemical exfoliating~     agents to the skin, which results in destruction of one or more parts of the epidermis~     and/or dermis with subsequent regrowth of these layers. Chemical peels are divided into~     superficial (light), medium, and deep; with superficial peels being the focus of this study.~     Superficial peels penetrate into the epidermis only, and are a safe, widely available and~     well-tolerated treatment modality. These peeling agents include glycolic acid, lactic acid,~     mandelic acid, salicylic acid and trichloroacetic acid, each with unique properties. For~     instance, alpha-hydroxy acids, such as glycolic acid, are known to be hydrophilic, whereas~     salicylic acid is lipophilic and anti-inflammatory.~      As each peeling agent has unique properties, it can be hypothesized that the combined use of~     these agents may result in better clinical outcomes than the use of an agent alone. Prior~     studies have demonstrated that the combined use of these peels are safe and effective in~     improving a variety of skin conditions including acne scars, hyperpigmentation, and~     infraorbital dark circles. Overall however, studies on the combined use of these chemical~     peels in the treatment of melasma are lacking.~      Therefore, the aim of this pilot study is to conduct a controlled comparison of the efficacy~     and safety of a combination peel (glycolic acid and salicylic acid) as compared to glycolic~     acid peel alone in the treatment of melasma.~   "
18690|NCT02812706|"~     Primary Objectives:~        -  Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with~          relapsed and refractory multiple myeloma.~        -  Phase II: To evaluate efficacy of isatuximab at recommended dose and to further~          evaluate the overall response rate (ORR) of isatuximab in Japanese patients with~          relapsed and refractory multiple myeloma.~      Secondary Objectives:~        -  To evaluate the safety including immunogenicity of isatuximab. The severity, frequency~          and incidence of all adverse events will be assessed.~        -  To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing~          schedule.~        -  To assess the efficacy using International Myeloma Working Group (IMWG) uniform~          response criteria.~        -  To assess the relationship between baseline CD38 receptor density on multiple myeloma~          cells and efficacy.~   "
18691|NCT02812693|"~     This phase I/II trial studies the side effects and how well pembrolizumab and imatinib~     mesylate work in treating patients with melanoma with c-KIT mutation or amplification that~     has spread to nearby tissue or other places in the body. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Imatinib~     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving pembrolizumab and imatinib mesylate may work better in treating patients with~     melanoma with c-KIT mutation or amplification that has spread to nearby tissue or other~     places in the body.~   "
18692|NCT02812680|"~     Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized~     to be associated with response to chemoradiation in patients undergoing treatment for~     locally advanced esophageal adenocarcinoma.~      The goal of this project is to assess the use of circulating microRNA (miRNA) and~     circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for~     neoadjuvant therapy.~   "
18693|NCT02812667|"~     The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an~     effect on cancer and body in combination with nivolumab, a standard treatment for metastatic~     squamous non-small cell lung cancer with progression on or after platinum-based~     chemotherapy.~      Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to~     the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that~     is not approved for use outside of research studies by regulatory agencies. Up to 38~     patients will be enrolled.~   "
18694|NCT02812654|"~     Prospective phase II study. Patients will be submitted to neoadjuvant chemotherapy (cT) and~     hypo fractionated radiotherapy (hRT) following by surgery. The remain viable cells will be~     analyzed and the patients whithin less than 30% will receive more 3 cycles of cT. All~     patients have deep high grade soft tissue sarcoma of extremity.~   "
18695|NCT02812641|"~     Esophageal squamous cell carcinoma (ESCC) is one of the ten leading cancers in Taiwanese~     male. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized~     clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant~     concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival~     for patients with locally advanced disease. Despite of the advancement, the outcome remained~     unsatisfactory with the median progression-free survival around 20 to 25 months and median~     overall survival around 30 months. It is know that the most important prognostic factor is~     whether a pathological complete response can be achieved after neoadjuvant CCRT. However,~     the use of new generation chemotherapeutic agent taxanes and epidermal growth factor~     inhibitors (such as Cetuximab) failed to significantly improve prognosis comparing to the~     standard platinum-fluorouracil (PF) regimen. As a consequence, it is mandatory to develop~     new chemotherapeutic regimen for CCRT.~      In previous prospective studies, investigators used proximal ligation assay technology to~     identify serum VEGF-A in correlation with the pathological response and prognosis for~     patients receiving neoadjuvant CCRT plus radical esophagectomy for locally advanced ESCC.~     Other investigators also showed high VEGF expression correlating to poor outcome. Therefore,~     investigators generate the hypothesis that adding vascular endothelial growth factor (VEGF)~     monoclonal antibody, Bevacizumab, to standard neoadjuvant CCRT may improve outcome for~     patients with ESCC. Meanwhile, several prospective clinical studies have shown the~     feasibility, safety, and activity of adding Bevacizumab to chemotherapy, CCRT, or combined~     modality therapy including surgery, either in head and neck cancer, esophageal cancer, or~     esophagogastric junction adenocarcinoma. However, its efficacy should be further~     investigated in larger prospective trials and little is known about the activity and~     toxicity of Bevacizumab in ESCC due to small number of reported cases. In the present~     clinical trial, investigators plan to investigate whether incorporation of Bevacizumab into~     standard neoadjuvant PF-CCRT will improve treatment response and increase pathological~     complete response rate. Investigators will also evaluate associated biomarkers in relation~     to prognosis. By the present research, investigators expect to develop a new TMT regimen for~     this poor prognostic disease.~   "
18697|NCT02812615|"~     This is a community-based intervention study which will be undertaken at Mirpur, Dhaka,~     Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18~     months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted~     children (length for age Z score, LAZ < -2), children who are at risk of stunting (length~     for age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished~     adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for~     any organic diseases and application of inclusion/exclusion criteria, they will receive~     nutrition interventions. Participants eligible for study will be tested for potential bio~     markers of environmental enteropathy (stool, urine and serum) once before and once after the~     nutritional intervention. Participants who will fail to respond to nutritional therapy~     (measured by anthropometric assessment) will become candidates for upper gastrointestinal~     endoscopy with biopsy. The study will include duodenal biopsies from a control group of~     children from University of Virginia Hospital in Charlottesville, Virginia who will undergo~     upper GI endoscopy as part of their clinical care as per the standard clinical protocol~     followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from~     international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical~     College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU),~     Dhaka.~   "
18698|NCT02812602|"~     Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal~     staples after total knee replacement~   "
18699|NCT02812589|"~     The breast MRI is used in the preoperative scenario to evaluate the extension of a newly~     diagnosed breast cancer and to screen the contralateral breast. The scan consists of a~     series of images taken after the use of intravascular contrast media that may detect areas~     of enhancement that look malignant, but are actually benign tissue, producing a false~     positive result. The investigators aim to evaluate a novel MRI sequence of images that does~     not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add~     significantly to the time of standard breast MRI exam. This novel technique provides~     improved detection of tissue microstructure and is able to differentiate malignant from~     benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive~     rate when compared with standard dynamic contrast-enhanced (DCE) MRI.~   "
18700|NCT02812576|"~     Data on neonatal GBS disease are very limited in China. Acceptance and implementation of~     prevention measures such as antibiotics prevention or vaccination against GBS disease would~     require robust data. This study as the first national, multicenter study to investigate the~     epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to~     appraise the necessity of appropriate interventions.~   "
18701|NCT02812563|"~     The principal objective of this study is to evaluate the frequency of KC inside family of~     patients with confirmed KC.~      It's a familial, epidemiological, prospective, single-center study.~   "
18702|NCT02812550|"~     The purpose of this study is to compare the adenoma detection rates of full-spectrum~     endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening~     programme.~   "
18703|NCT02812537|"~     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the~     basic rights of others or major age-appropriate norms are violated. So defined, these~     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder~     management is a public health issue and a societal question. Conduct disorders affect 5 to~     9% of 15-year old boys.~      Care management of children and adolescents admitted for disruptive behaviors in emergency~     rooms is an issue. No consensus or official recommendation exists. However, use of emergency~     care in this context is increasing in most western countries and it exposes to several risks~     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and~     suicide risk). The Trajectories project is designed to describe children and adolescents~     with disruptive behaviors, their care management and to follow their life trajectory and~     psychiatric evolution after admission to emergency rooms. Better understanding this~     population will improve their medical and social care management, thereby giving~     professionals the right tools.~      The main objective of this project is to implement a multidisciplinary and integrative~     research combining clinical considerations and social sciences to determine the trajectory~     of this population.~   "
18704|NCT02812524|"~     This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This~     study will test the feasibility of the administration of intratumoral injections of~     ipilimumab prior to surgical resection, and the immune system response to treatment.~   "
18705|NCT02812511|"~     The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the~     molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and~     the effects of this mutation on energy metabolism and mitochondrial physiology.~   "
18706|NCT02812498|"~     The purpose of this study is to compare the effects on glycemic control of Teleconsultation~     versus standard visit in outpatient clinic for patients affected by type 1 diabetes~     mellitus.~   "
18707|NCT02812472|"~     The purpose of this study was to investigate the effects of the treadmill training with~     functional electric stimulation on sensorimotor cortical reorganization and functional~     improvement in subjects with chronic stroke.~   "
18708|NCT02812459|"~     The purpose of this study is to analyze the effectiveness of electrical stimulation and~     kinesio taping in combination with exercise in People with Chronic Low Back Pain~   "
18709|NCT02812446|"~     The purpose of this study is to identify bacterial and/or clinical features involved in the~     pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials &~     methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were~     studied. Staphylococcus aureus genetic background was obtained by microarray analysis.~     Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm~     production was investigated by resazurin and crystal violet methods~   "
18844|NCT02810730|"~     Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is~     increasing both in France and in Europe, whereas all the other cancers are decreasing in~     Europe. Moreover, its seriousness is still high, with a mortality rate higher than the~     average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic~     anomalies which can be revealed thanks to imaging, for patients having a 1st degree~     pancreatic adenocarcinoma familial history. This could allow detection of lesions which are~     less than 10 mm long, and improve the dark prognostic of this pathology.~   "
18710|NCT02812433|"~     Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious~     condition causing significant mortality and long-term morbidity, including cerebral palsy~     and mental retardation. Currently, no treatment exists to repair brain injuries secondary to~     neonatal asphyxia. The only available treatment for this condition is hypothermia that may~     prevent but not repair the development of brain injury. The success of this therapy is~     limited.~      Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary~     hypertension), but, surprisingly, its effect on the newborn brain has never been studied~     systematically. The findings of the investigators in the rat model of term neonatal~     encephalopathy demonstrated that the administration of sildenafil following asphyxia~     promotes brain injury recovery. Thus, the investigators hypothesize that sildenafil may~     improve neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia~     treatment has failed to prevent the development of brain injury.~   "
18711|NCT02812420|"~     The goal of this clinical research study is to learn if the combination of durvalumab and~     tremelimumab is safe and tolerable when given to patients with bladder cancer before surgery~     to remove the bladder.~   "
18712|NCT02812407|"~     Does baseline impedance measured during the landmark phase of esophageal High resolution~     impedance manometry HRIM correlates with direct mucosal impedance measurement and~     discriminates GERD from non GERD patients?~   "
18713|NCT02812394|"~     This study will be an open-label, randomized, three-period cross-over pharmacokinetic~     evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered~     carbidopa/levodopa, in healthy volunteers.~   "
18714|NCT02812381|"~     The suture of the supraspinatus tendon is a common surgery that requires physical therapy~     for back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is~     being used to treat myofascial trigger points that appear after surgery and for the~     treatment of physiotherapy in the supraspinatus muscle and deltoid.~      To evaluate the effectiveness of KT technique over the technique of Jones~     (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus~     muscle.~   "
18715|NCT02812368|"~     Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder~     (ASD) and is the source of considerable stress for the affected individual and family. Sleep~     plays a role in development and learning processes; thus, the appropriate treatment of sleep~     disturbance is paramount to optimal outcomes. The empirical base for treatments to address~     sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to~     target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep~     disturbance in children with ASD will allow investigators to evaluate the feasibility of~     conducting a much larger multisite trial to address the general lack of systematic data~     available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive,~     with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO),~     parallel groups study will test the efficacy of CLN following a brief sleep hygiene~     intervention. Outcome measures include: informant completed sleep questionnaires, daytime~     behavior questionnaires, and actigraphy. Biomarkers for medication response will include~     galvanic skin response and skin temperature. Side effects will be monitored throughout the~     study.~   "
18716|NCT02812355|"~     The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded,~     unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is~     designed to test in patients undergoing off-pump coronary artery bypass surgery the~     hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are~     not different in terms of thrombotic complications and major perioperative bleeding events~     (null hypothesis).~   "
18717|NCT02812342|"~     The purpose of the study is to investigate the use of topical tofacitinib to promote hair~     regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.~   "
18718|NCT02812329|"~     This study aims to minimize risk of human immunodeficiency virus (HIV) in adolescent boys~     and girls, ages 15-16, by promoting HIV testing and counseling (HTC) through the use of an~     interactive videogame. With input from focus groups of adolescents, the investigators will~     adapt an HIV prevention videogame, PlayForward: Elm City Stories, for adolescents ages 15-16~     . The investigators will then pilot test the videogame in 30 adolescents to assess the~     acceptability and feasibility of the videogame. They will also assess whether the videogame~     increased the participants' intentions to obtain HTC, whether they actually obtained HTC,~     and whether the videogame increased knowledge of HIV.~   "
18719|NCT02812316|"~     Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable~     contact lens (hexafocon b) test when worn on a daily wear basis in the correction of~     myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.~   "
18720|NCT02812303|"~     A pilot program was created by the network's primary care leadership team at Massachusetts~     General Hospital. A population health management program was implemented for chronic disease~     management. The investigators evaluated quality of care process and outcome measures over~     the first six months of the program and compared practices assigned a central population~     health coordinator to those not assigned this support.~   "
18721|NCT02812290|"~     Objective: To evaluate the potential impact of molecular phenotyping of transbronchial~     biopsies in lung transplant recipients with allograft dysfunction, and the potential for~     developing a safer endobronchial mucosal biopsy format.~   "
18722|NCT02812277|"~     This is a single centre, observational and retrospective clinical study. The study group was~     about all HR positive postmenopausal breast cancer patients who were hospitalized between~     January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up~     data.~   "
18723|NCT02812264|"~     This study will test the effectiveness of a mobile application that uses an Application~     Program Interface (API) to distribute evidence-based weight loss interventions. Half of the~     participants will receive this API-based application, and the other half of the participants~     will use a non API-based application.~   "
18724|NCT02812251|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215~     versus placebo after single oral dose administration under fasted (ascending dose levels)~     and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma,~     cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate~     the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following~     single oral dose administration.~   "
18725|NCT02812238|"~     Background:~      The immune system controls how the body responds to infection or injury. Researchers want to~     see what effect a dietary supplement called nicotinamide riboside (NR) has on the immune~     system. A study showed that fasting has a good effect on immune cell health in healthy~     people. And when immune cells were exposed to NR they had a similar positive response as~     with fasting. Researchers want to see if healthy people have the same effects from NR and~     fasting, and if those effects last.~      Objectives:~      To see if taking nicotinamide riboside will have the same healthy immune system effects as~     fasting. To see if these good effects continue even after eating again.~      Eligibility:~      Healthy volunteers ages 18 39~      Design:~      Participants will be screened with medical history, physical exam, and blood tests. Women~     will have a urine pregnancy test.~      Participants will take 4 pills of either NR or a placebo once a day for 1 week.~      On day 6, they will not eat or drink anything.~      On day 7, they will have a study visit to give a blood sample before and after eating a meal~     at the clinic.~      They will also give a urine sample.~      Participants will stop taking the pills for 1 2 weeks.~      Participants will take either NR or a placebo once a day for 1 week.~      They will repeat day 6 and day 7 of the first week.~      Participants will get NR once and placebo once, but will not know which they are taking.~   "
18726|NCT02812225|"~     The multi-center study evaluates BrainPulse recordings from subjects with a suspected or~     confirmed concussion to improve a concussion detection algorithm. Subjects may also consent~     for a 5 additional follow-ups over a 21-day period to compare the progression of change in~     their BrainPulse recordings.~   "
18727|NCT02812212|"~     Cortical transit time on diuretic renogram as an early marker of significant obstruction in~     antenatally detected uretero-pelvic junction syndrome~   "
18728|NCT02811367|"~     The purpose of this study is to find out whether Self-HPV may be an accurate method for the~     follow-up of women with a history of HPV infection.~   "
18729|NCT02811354|"~     Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection~     of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR~     sensitizing mutations and T790M detected in plasma ctDNA.~      This is a prospective, open label, multi-centre single arm phase II study assessing the~     efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring~     sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and~     T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately~     106 subjects will be enrolled.~      All patients must have documented radiological progression on EGFR-TKI treatment and on the~     last treatment administered prior to enrolling in the study.~   "
18730|NCT02811341|"~     Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal~     endoscope examination.~   "
18731|NCT02810288|"~     Respiratory adverse events continue to be the leading reason for perioperative critical~     events in children. It is crucial for the anaesthesiologist to anticipate, recognize and~     treat these respiratory adverse events. Respiratory adverse events are one of the major~     causes of morbidity and mortality during paediatric anaesthesia. To avoid trouble, one must~     be prepared for trouble: if a difficult airway is very likely, anaesthesia should be~     administered by experienced anaesthesiologists and should only be performed in a protected~     well-equipped area where the personnel adequately trained.~      This survey focuses on assessment and management of paediatric airway and highlights the~     unique challenges encountered in children.~   "
18732|NCT02810275|"~     Patients infected by HIV or HIV-HCV coinfected have higher survival due to the use of HAART,~     but survival is accompanied by increased morbidity and associated cardiovascular disease~     (CVD). Endothelial dysfunction is an early marker of atherogenesis, acting as an~     intermediate in the causal pathway of CVD. Folinic acid (FA) has been shown to reduce CVD~     outcomes, especially among individuals with hyperhomocisteinemia.~      To date, few studies provided consistent information about efficacy of pharmacological~     interventions that minimize damage to the vascular endothelium in patients infected by HIV~     or HIV-HCV coinfected. The main hypothesis of this study is that FA supplementation protects~     the vascular endothelium, and consequently might prevent subclinical atherosclerosis. Thus,~     the first step is to determine the efficacy of supplementation with FA, and to compare the~     effect between HIV and HIV-HCV coinfected.~   "
18733|NCT02810262|"~     Mortality due to non small cell lung cancers is the first cause of cancer death in men~     around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high~     morbidity and impaired life quality. Overall survival of these patients is poor. Thus the~     investigators aimed to identify if some bone and metabolic parameters were associated with~     overall survival.~      Patients and Methods POUMOS is a prospective cohort of patients suffering from~     adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a~     bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and~     ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole~     body composition is obtained by DEXA scan (Hologic®). The investigators assessed also~     fasting blood levels of bone and metabolic biomarkers.~      Survival analyses will be performed using a proportional hazard regression model.~   "
18734|NCT02810249|"~     HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has~     been approved by the FDA as a method for reducing HIV transmission rates in the population,~     particularly young men who have sex with men (YMSM). This study will use a qualitative~     design to interview 20-30, HIV-negative, 16-24 year old African American YMSM to: 1)~     identify and understand African American YMSM's, aged 16-24, cognitive and emotional~     processes in response to using PrEP to reduce their risk for HIV and 2) identify what~     factors (sociocultural, individual, experiences in health care, socioeconomic) influence~     African American YMSM's likely use of PrEP as a coping strategy for HIV prevention.~     Demographic information will be collected and analyzed using Statistical Analysis Software~     version 9.3. Individual interviews will be audio recorded and transcribed by a vetted~     transcription service for analysis. This is minimal risk to participants.~   "
18856|NCT02810574|"~     The purpose of this study is to determine whether combining noninvasive brain stimulation~     with cognitive training can reduce craving in adults with tobacco use disorder.~   "
19196|NCT02805985|"~     This study is a post-market clinical follow-up study. A post-market, prospective clinical~     trial will be conducted. The data collected from this study will serve the purpose of~     confirming safety and performance of the FLXfit™ implant.~   "
18735|NCT02810236|"~     The investigator hypothesizes that a benign directed ultrasound, when performed after a~     normal digital mammogram, will provide women with focal breast pain additional reassurance~     that the etiology of their symptom is benign. 160 women over the age of thirty with focal~     breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 -~     7/1/2018 will be selected and randomized to three groups using a block randomization~     technique. All study participants will complete a survey assessing psychosocial factors,~     then receive a digital mammogram. Patients with a negative mammogram will continue on with~     the study and will either have a conversation about their negative mammogram with a~     radiologist or receive a directed ultrasound. A second survey will be conducted assessing~     psychosocial factors. All study participants who did not receive an ultrasound will receive~     an ultrasound so that all study participants are provided with the standard of care for~     focal breast pain. The results of the survey will be compared and appropriate statistical~     analyses such as an Analysis of Variance (ANOVA) test will be conducted to determine any~     statistically significant differences between the three randomized groups. The risks/safety~     issues of this study are believed to be minimal.~   "
18736|NCT02810223|"~     This is a single arm, open-label, multi-center study to determine the efficacy and safety of~     an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell~     ALL.~   "
18737|NCT02810210|"~     The Zika epidemic has spread into the three French Overseas Departments in the Caribbean~     (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for~     the evaluation of potential complications due to having ZIKV infection during pregnancy.~      This study is meant to collect, within usual care practices, clinical and paraclinical~     information (including imaging and laboratory results) as well as biological samples~     allowing the precise description of the consequences of ZIKV infection during pregnancy.~      This study is the 2nd arm of a global research program in the 3 French Overseas Departments~     in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the~     follow-up of women in the French Overseas Departments who are pregnant during the Zika~     epidemic period.~      The study population is made up of infants born during and up to 9 months after the end of~     the Zika epidemic period in the French Overseas Departments.~      The data and biological specimens collected for this project will be done so through the~     recommended standard of care which has been put in place considering the ZIKV epidemic in~     the 3 French Overseas Departments, upholding existing recommendations (profession and/or~     recommendation from the public health authorities)~   "
18738|NCT02812186|"~     This is a two period cross-over study randomizing patients undergoing laparoscopic surgery~     into 2 different groups: group 1 in which patients receive deep neuromuscular blockade in~     the beginning portion of their laparoscopic surgery followed by a period of moderate~     blockade and, group 2 in which patients receive moderate neuromuscular blockade in the~     beginning portion of their laparoscopic surgery followed by a period of deep blockade. The~     deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate~     neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to~     reverse the block at the end of surgery in order to obtain optimal extubating conditions.~   "
18739|NCT02812173|"~     The purpose of the study is to determine, whether the postoperative quality of micturition~     and continence can be improved depending on the urinary drainage catheter and retention~     after robot assisted radical prostatectomy. Another finding could be the study of the pain~     assessment of the patient, as well as the pain medication at the various derivatives.~     Further check whether infections and the presence of bacteriuria can be reduced or avoided~     by the form of urinary drainage.~   "
18740|NCT02812147|"~     This research study is being done to determine whether treatment with L-~     Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study~     drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and~     reduce risk of falls and/or severity of falls in PD subjects. The study is also being done~     to determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will~     decrease Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a~     relationship between apathy and slowed movement and fall risk.~   "
18741|NCT02812134|"~     Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced~     by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action~     and inhibition of 1,25-OH vitamin D).~      There are no published studies on the role of FGF23 in undernourished anorexic adolescents~     taking oral phosphorus supplements.~   "
18742|NCT02812121|"~     Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease~     with high mortality. Our previous study have demonstrated that peripheral infusion of bone~     marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24~     weeks survival rate of ACLF patients. In this study, we intend to assess the safety and~     efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.~   "
18743|NCT02812108|"~     This study was designed to collect a large series of patients with aneurysms treated~     endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.~   "
18744|NCT02812095|"~     Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end~     of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance,~     cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the~     efficacy and safety of the practice of refeeding in preterm infants with enterostomy.~     Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other~     laboratory findings will be collected. Serial citrulline levels during refeeding procedure~     and pathologic specimens of bowel (at the time of stoma closure) will be collected for~     evaluating bowel adaptation.~   "
18745|NCT02812082|"~     The purpose of this study is to develop an interactive web-based patient education program~     to help educate patients about the increased risk of MS and its cardiac risk factors~     following allo-SCT and to inform and motivate patients how to make lifestyle changes. This~     program will be used in addition to counseling at participants clinic visits. The~     investigators are not changing the recommendations for prevention and management of these~     conditions, but rather are trying to improve the way they provide this education to~     patients.~   "
18865|NCT02810457|"~     The purpose of this research study is to compare the effectiveness and safety of FKB238~     against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung~     cancer~   "
18746|NCT02812069|"~     Hypothermia during surgery and in the postoperative period is associated with adverse~     outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune~     function, coagulopathy, and increased use of hospital resources. Several clinical studies~     have demonstrated that maintenance of normothermia during the perioperative period~     significantly reduces morbidity.~      Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers~     adequate heat through hands and feet based on the physiological principle of peripheral~     arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective~     thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts~     and triggering arterio-venous shunt vasodilation and by applying circulating water heat~     exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that~     area.~      General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by~     1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether~     cervical spine warming further augments arterio-venous shunt dilation during general~     anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart~     warming could be simpler and less expensive. Investigators therefore propose to test the~     hypothesis that cutaneous heating near the cervical spine does not further augment~     arterio-venous flow in fingers during general anesthesia.~      Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed~     intraoperatively with forced-air to maintain a core temperature near 36°C.~      A ThermaZone® Device capable of heating the cervical spine area will be positioned behind~     the patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer~     will be positioned appropriately and activated as soon as practical, usually after prepping~     and draping. Ambient temperature will be maintained near 20°C.~      After about one hour of anesthesia when temperature and other factors are stable,~     investigators will start a 30-minute observation period. Thereafter investigators will~     activate the cervical spine warming system for 30 minutes (warming measurement period) and~     thereafter have a 30 minutes control period again.~      Measurements will be recorded such as mean-skin temperature, distal esophageal temperature,~     MAC fraction, mean-arterial pressure and finger blood flow.~   "
18747|NCT02812056|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of alisertib and TAK-228 that can be given to participants with advanced solid~     tumors that are associated with HPV. Researchers also want to learn if the study drug~     combination can help to control advanced solid tumors.~   "
18748|NCT02812043|"~     This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser~     and the combination between amorolfine and long-pulsed Nd:YAG in treating the~     non-dermatophyte and mixed-infection onychomycosis.~   "
18749|NCT02812030|"~     Diabetic retinopathy remains the leading cause of blindness in patients of working age in~     the Western World, and there is a global epidemic of diabetes. The recommended treatment for~     diabetic retinopathy involves injection of anti-vascular endothelial growth factor~     (anti-VEGF) into the eye. Based on two recent clinical trials taking place in the United~     States, Europe, Japan, and Australia, NICE issued guidance in July 2015 recommending that~     aflibercept (a particular type of anti-VEGF treatment) should be available on the NHS for~     patients in whom the central retina of the eye is at least 400 micrometres thick before~     treatment.~      Real-world data can differ significantly from clinical trial data, and it is therefore very~     important to evaluate the impact of aflibercept in a real world setting, particularly with~     respect to systemic control, as patients with poor systemic control were excluded from the~     clinical trials. This study aims to demonstrate the efficacy of aflibercept in a real-world~     setting, and how this compares to the clinical trial setting.~   "
18750|NCT02812017|"~     This comparative study of will evaluate the effectiveness of promoting critical language and~     cognitive development in infants of low-SES English- and Spanish-speaking parents. TMW-WB~     will target infants zero to six months and their parents during routine Well Baby pediatric~     visits at one week, one month, two months, four months, six months, and a final nine month~     follow-up.~   "
18751|NCT02812004|"~     The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of~     vitreous floaters. No randomized controlled clinical trial has been carried out to this day~     in order to investigate its superiority over sham treatment.~      In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up~     to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment.~     After a maximum of two (sham) treatment sessions (1 per month), patients' utility value~     score and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1,~     6 and 12 post-treatment) will ensue the treatment phase to register any late adverse~     events that may be associated with laser vitreolysis.~      As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to~     severe cases only, laser vitreolysis may present a valuable treatment option for patients~     with moderate vitreous floaters that are not eligible for vitrectomy.~   "
18752|NCT02811991|"~     Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal~     analgesia. This medication is generally safe, well tolerated and effective within~     recommended daily dose.The purpose of the study is to evaluate the efficacy and safety of~     Paracetamol Injection as adjuvant to morphine-based post-operative analgesia, as well as to~     explore the reasonable dosage of paracetamol among Chinese population under above-mentioned~     circumstance.~   "
18753|NCT02811978|"~     The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to~     intravenous velcade when administered in combination with low-dose dexamethasone in chinese~     refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall~     response rate at the end of 4 cycles of velcade and dexamethasone administration.~   "
18754|NCT02811965|"~     Prevention of heel pressure ulceration is a major clinical concern. Clinical research has~     shown that heel-offloading devices are effective at preventing heel ulceration when compared~     to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload~     the heel). As a result, a plethora of heel-offloading devices have been developed that~     utilize different designs and materials to offload the heel. Despite the availability of~     these devices, some healthcare facilities still employ no heel offloading or utilize~     sub-optimal heel offloading strategies. It is also difficult for clinicians to compare the~     effectiveness of different heel offloading device without conducting extensive clinical~     evaluations. Pressure mapping of the pressure experienced by the heel while offloaded offers~     a potential method to assess the effectiveness of different heel offloading strategies.~      The primary hypothesis of this study is that the three tested heel offloading devices will~     significantly decrease the heel contact forces compared to no offloading and sub-optimal~     heel offloading conditions. The secondary objective is to quantify differences in heel~     contact forces experienced by the heel when placed in each heel offloading device to~     demonstrate the utility of pressure mapping as a tool to evaluate the effectiveness of~     different heel offloading devices.~      The study will recruit 21 healthy volunteers as research subjects with 7 having a normal~     BMI, 7 having an overweight BMI, and 7 having an obese BMI. Pressure mapping will be~     conducted on each research subject for seven randomly applied conditions while the patient~     lies comfortably in a hospital bed. The seven conditions include no heel offloading, 3~     sub-optimal offloading conditions, and offloading in 3 different heel-offloading devices.~     Pressure measurements corresponding to the heel will be used to determine the average peak~     pressure contact force for each research subject in each condition.~   "
18755|NCT02811952|"~     In many of urothelial carcinoma patients, one does not find common risk factors such as~     smoking. The medical center is located in an industrial city with known air and water~     pollution. The investigators decided to check the presence of nano particles and traces of~     metals in urinary samples of patients known and suspected for urothelial carcinoma and~     compare the results to both cystoscopic and cytological findings. The patients will fill a~     validated epidemiological respiratory disease survey and the results will be compared to a~     control group.~   "
18758|NCT02811913|"~     Stroke affects over 795,000 Americans every year and has an enormous impact on the~     well-being of American Veterans with 6,000 new stroke admissions every year. Many of these~     stroke survivors are living with disabilities that limit their everyday function. One of the~     major consequences of stroke is loss of sensation which manifests as inability to perceive~     touch, temperature, pain or limb movement. Lack of sensation hinders full functional~     recovery. Current treatments for sensory loss produce only limited improvements and do not~     achieve full recovery. Therefore, it is critical to develop new therapies to re-train~     sensory function. The investigators propose to evaluate a novel non-invasive brain~     stimulation treatment called repetitive Transcranial Magnetic Stimulation (rTMS). The~     effects of this technique on motor deficits following stroke have been studied, however rTMS~     for the treatment of sensory loss has not been examined to date. The investigators' study~     will examine for the first time if rTMS of a sensory brain region can improve sensory~     function in chronic stroke survivors.~   "
18759|NCT02811900|"~     A prospective bariatric database was carried out in the Department of Digestive and~     Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January~     1996. All potential candidates for obesity surgery were prospectively registered in the~     database. Patients were informed by the bariatric surgeon of the prospective database, and~     of the possibility of utilizing personal data for research purpose after anonymization.~      A case-control study was performed, to compare the quality of life (QoL) of patients treated~     for internal hernia (IH group) with the QoL of patients with an uncomplicated course after~     Roux en Y gastric bypass (Uncomplicated RYGB group).~   "
18760|NCT02811887|"~     To investigate whether simple reminders about healthy lifestyle sent via mobile phone text~     messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD~     score supported by the Child-Pugh score) among patients with liver cirrhosis that have been~     through a 12-week supervised and facility-based physical exercise training program and~     in-patient rehabilitation.~   "
18761|NCT02811874|"~     The aim of this study is to evaluate the effect of a diabetes education program delivered to~     CHW in improving the metabolic control of patients with type 2 DM.~      The study is a randomized controlled trial conducted in a primary care unit. Eight CHW,~     providing care for 118 patients, are randomized in two groups to receive a one-month~     diabetes education program (intervention group, patients n= 62) or an education course in~     other health issues (control group, patients n= 56).~   "
18762|NCT02811861|"~     This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and~     safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus~     sunitinib (Arm C) as first-line treatment in participants with advanced renal cell~     carcinoma.~   "
18763|NCT02811848|"~     The purpose of this study is to develop and pilot test recruitment methods for a future~     study of prevention of sexually transmitted infections (STI), including the human~     immunodeficiency virus (HIV), among Black adolescent boys through sexual health education by~     their fathers.~   "
18764|NCT02811835|"~     Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term~     (10-year and longer) results are, however, still disappointing. Where most research has~     focused on immunosuppression and infections, the investigators hypothesize that due to poor~     homeostatic capacity and necessary use of immunosuppressive and other drugs, renal~     transplant recipients are much more susceptible to poor dietary habits and exposure to~     potentially toxic contaminants than people of the general population, and that this~     contributes to accelerated function loss of the graft and excess risk of premature~     mortality, both contributing to poor long-term results. This study is a biobank and cohort~     study which investigates this hypothesis.~   "
18765|NCT02811822|"~     This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as~     adjunct to standard of care chemotherapy used to treat this disease.~   "
18766|NCT02811809|"~     This study is open to men who have biochemical recurrence (BCR, increased PSA) following~     local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard~     treatment option, but is only effective for 16-24 months and has a number of side effects~     that impact quality of life. These side effects may include fatigue, hot flushing, loss of~     sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low~     levels of red blood cells that can make people feel tired and weak), diabetes (low blood~     sugar), heart disease, metabolic syndromes (sometimes called pre-diabetes and includes~     obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood),~     and risk of fractures. An alternative to continuous ADT is intermittent administration,~     where patients are given breaks from ADT to let their testosterone levels return to~     baseline. There are a number of potential benefits to intermittent hormone therapy (IHT):~     (1) longer time to the development of resistance; (2) improved patient quality of life owing~     to recovery from adverse effects, particularly sexual function; and (3) substantial cost~     savings owing to less time spent receiving medication. Leuprolide is the name of the ADT /~     IHT drug.~      Apalutamide is an investigational drug, which means it has not been approved by the Food and~     Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this~     study is to determine the ability of Apalutamide to extend the time between the first two~     injections of leuprolide and improve quality of life. This study will also look at the~     safety of Apalutamide and the effects that Apalutamide has on prostate cancer.~      Men will be randomized (like flipping a coin) to receive:~        -  Group A: Leuprolide + Apalutamide or~        -  Group B: Leuprolide only (until second leuprolide injection), then leuprolide +~          Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is~          given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide~          is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long.~      Intermittent treatment with Apalutamide + leuprolide will continue until continuous~     leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above~     undetectable level unless leuprolide is given without pause, every 3 months).~   "
18767|NCT02811796|"~     The investigators will collect prospectively baseline, procedural and follow-up data of all~     patients receiving successful percutaneous coronary intervention (PCI) and stent~     implantation. Angio-based flow fractional reserve (QFR system, Medis medical imaging systems~     Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at~     the end of the procedure (this is defined according operator's judgement) will record 2~     orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2~     orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural~     data and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and~     one with those at 30 frames~   "
18768|NCT02811783|"~     This multi-center, double-blind, vehicle-controlled, randomized crossover design study will~     evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the~     treatment of pruritus in patients with the mycosis fungoides (MF) form of Cutaneous T-cell~     Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug~     in a subset of subjects and if so, describe the range and mean plasma levels reached after~     two weeks of three time daily (TID) dosing.~      Funding Source - FDA OOPD~   "
18769|NCT02811770|"~     Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This~     condition is responsible for 10-15% of glomerulonephritis in children. The outcome is~     generally favorable, but up to 5% of patients develop kidney failure. The outcome of~     patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic~     renal failure.~      Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at~     6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United~     Kingdom. The proportion of children with HS who develop renal disease is difficult to~     determine because the numbers reported in the literature are variable and depend greatly on~     the type of the reporting center, whether or not specialized in pediatric nephrology. Thus~     the proportion of renal disease varies from 20% to 100% of children with a HS.~      The treatment of HS nephropathy (HSN) usually depends on the severity of histological~     lesions but histological classification is discussed and there is currently no consensus.~     Randomized studies are scarce and often do not allow to draw clear conclusions. A~     meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe~     forms but in this study the definition of renal disease was very heterogeneous. The only~     classification of the HSN recognized is from the International Study Group of Kidney Disease~     in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade~     II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/~     segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI:~     pseudomesangiocapillary. However, this classification is questioned because it ignores other~     significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular~     and interstitial inflammation, the appearance of crescents (segmental or totally~     encompassing the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and~     arteriolar appearance in immunofluorescence.~      There is currently no consensus on the criteria indicating the initiation of corticosteroid~     therapy whether oral or intra venous bolus. Some patients with severe clinical and / or~     histological initial presentation can evolve to remission spontaneously while others who~     have more moderate initial symptoms will evolve later to kidney failure. The management is~     therefore heterogeneous. In France, some centers perform a kidney biopsy almost always~     before starting treatment (or in the days following the start of treatment), while in other~     centers's treatment decision is based on the biology resulting from the glomerular disease,~     kidney biopsy being performed possibly in a second time in case of failure of the initial~     treatment.~      Principal objective of the study: assessment of the interest for the long term outcome of~     performing early a kidney biopsy (before the establishment of treatment or within 15 days~     after the start of treatment) in children with HSN compare to kidney biopsy performed later~     (depending on the response to initial therapy) or not performed.~      Secondary objective: assessment of the impact of early kidney biopsy (before the~     establishment of treatment or within of 15 days after the start of treatment) on the initial~     treatment HSN : does it modify or not the treatment started right before it (decided on~     clinical and biological criteria).~   "
18770|NCT02811757|"~     Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often~     associated with cuff tendinopathy. The function of the LHB in the shoulder is still~     controversial and uncertain, whereas its function in the elbow is certain. The biceps~     brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic~     long head of the biceps permits pain relief and is very reliable in the literature. Two~     options are available for the remaining tendon : simple tenotomy or tenodesis which consists~     to reattach the tendon to the humerus. Our hypothesis is that there is no difference in~     strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim~     of this study was to compare the strength and the endurance of the biceps brachii during~     supination and flexion after tenotomy or tenodesis of the LHB.~      the investigators proposed a prospective and randomized study. All the patients treated in~     our department for an arthroscopic rotator cuff repair were included in this study after~     signed consent. Participants will complete isokinetic strength and endurance testing for~     elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year~     after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion~     measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.~   "
18771|NCT02811744|"~     Our proposed study aims to use 11C-acetate PET/CT to preliminarily test and validate methods~     for imaging astrocyte activation as an early indicator of neuroinflammation in Alzheimer's~     disease (AD). 11C-Acetate PET/CT has been shown to quantify astrocyte activation in vivo,~     but no reports have evaluated its potential in AD. We propose to test 11C-Acetate PET/CT as~     a marker for astrocyte activation associated with pathologic amyloid deposition in AD. We~     will compare binding between subjects with early stage AD and healthy controls. Further, we~     will investigate the correlation between amyloid and acetate binding. If we find increased~     astrocyte activation in response to cerebral amyloid by showing a group difference in brain~     acetate uptake between disease and controls or a strong correlation between acetate and~     amyloid PET/CT binding. Validating neuroinflammation markers in AD ultimately may guide~     therapeutic modulation of beneficial and damaging neuroinflammation to slow disease~     progression, as well as providing new insights into AD pathophysiology.~   "
18772|NCT02811731|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of~     the two separate drugs in healthy male volunteers.~   "
18773|NCT02811718|"~     The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious~     and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are~     deaf or have severe hearing loss using Communication Access Realtime Translation (CART)~     and/or American Sign Language (ASL).~      This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study~     except it is looking at a particular sub-population: patients with NF2 who are hard of~     hearing.~   "
18774|NCT02811705|"~     This cohort study aims to assess the quality of life (or welfare) related to the health of~     children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall~     syndrome to compare it to children or adolescents with recurrent fever genetics of Familial~     Mediterranean fever (FMF) in order to improve their overall care.~   "
18775|NCT02811692|"~     The French CODEX study is designed as a national database to describe, in routine medical~     practice, functional and anatomical responses to intravitreal Aflibercept injection, in a~     large population of anti-VGEF-naïve patients presenting with wet Age-related Macular~     Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein~     Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather~     databases from French private and public ophthalmologic centers.~   "
18776|NCT02811679|"~     This research study is studying Blinatumomab as a possible treatment for Indolent~     Non-Hodgkin Lymphoma (NHL).~   "
18777|NCT02811666|"~     Sarcopenia (loss of muscle mass and function) can be observed at any age and results of~     multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply~     impacts the physical performance and the basal metabolism, and induces cardiovascular~     disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor~     decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing~     mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on~     postoperative course in digestive oncology. The search for sarcopenia, complementary~     nutritional status, is now a source of great interest with 62 ongoing projects in the United~     States.~      The first objective of this study is to evaluate the impact of preoperative sarcopenia on~     30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal~     cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative~     sarcopenia on the long term outcomes (12 months) on the same patients.~   "
18778|NCT02811653|"~     In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by~     motor slowing) have not been thoroughly characterized.~   "
18779|NCT02811640|"~     Patients treated with peritoneal dialysis (PD) are at increased risk of developing~     mechanical complications such as dialysate leaks and hernias thought to be related to an~     increase in intra-abdominal pressure (IAP) secondary to the addition of dialysate to the~     abdomen. Resistance training has been shown to increase IAP but it is unclear in the general~     population and in patients treated with PD if this training increases the risk of developing~     hernias.~      This study is observing the difference in IAP pressure measurements obtained by the Stryker~     pressure monitor versus the standard IAP pressure measurements obtained with the insufflator~     at the time of PD catheter insertion.~   "
18834|NCT02810860|"~     Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after~     an operation to remove their gallbladder for the treatment of symptomatic gallstones. This~     PROMs data will provide information to clinicians and trusts about the health gain following~     this type of surgery and the impact on patient's quality of life.~      This information will be collected by the implementation of the patient Website~     aboutmyop.org. This will not only allow patients to complete quality of life (PROMs)~     questionnaires online, but will also allow them to access information on their condition and~     necessary surgery, in addition to post-operative follow-up.~   "
18866|NCT02810444|"~     This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in~     treating patients with Primary Immunodeficiency (PID)~   "
19197|NCT02805972|"~     The purpose of this study is to understand how the opioid system is involved in eating~     behavior.~   "
18780|NCT02811627|"~     Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible~     therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric~     acid, GABA) imbalance in autism pathology and improves social and communication deficits.~     While some studies have shown positive results, a large clinical trial failed to show~     benefit possibly because different subsets of autism responded differently to the treatment.~      The investigator proposes a pilot, exploratory, clinical follow-on study using proton~     magnetic resonance spectroscopy (1H-MRS) to determine whether baseline glutamate/GABA levels~     in certain regions of the brain may help predict treatment response to Memantine in autistic~     subjects. At study onset, subjects will be assessed on the behavioral scales such as the~     Aberrant Behavior Checklist and Clinical Global Impressions scale, followed by MRS imaging.~     Memantine treatment will be started post imaging. Assessment measures will be repeated at~     week 12 during treatment. Glutamate and GABA levels in brain regions will be correlated to~     improvements on assessment measures. Expected results include higher glutamate and/or lower~     GABA levels in the anterior cingulate cortex at baseline in responders to memantine. If the~     hypotheses are confirmed, it will provide evidence of a relevant neural biomarker to predict~     treatment response to memantine with important implications for clinical care including~     improving individualization of treatments.~   "
18781|NCT02811614|"~     The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains~     controversial. Two main types of minimally invasive surgery, endoscopic evacuation and~     stereotactic aspiration, have been attempted for hematoma removal and show some advantages.~     However, prospective and controlled studies are still lacking. This is a multi-center~     randomized controlled trial designed to determine whether minimally invasive surgeries will~     improve the outcome in patients with hypertensive intracerebral hemorrhage compared with~     craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration~     group and craniotomy group in a 1:1:1 ratio.~   "
18782|NCT02811601|"~     This will be a single-arm prospective internally-controlled study. Patients will undergo~     percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments~     are added or substituted for conventional 5 or 10 mm trocars.~   "
18783|NCT02811588|"~     The prevalence of chronic respiratory disease, including chronic obstructive pulmonary~     disease (COPD), is increasing in industrialized countries. Over the next decade deaths from~     COPD are projected to increase by more than 30% and COPD will become the third leading cause~     of death worldwide by 2030. There is robust scientific evidence that non-invasive~     ventilation (NIV) therapy is an effective option for most COPD patients hospitalized with~     acute hypercapnic respiratory failure secondary to an acute disease exacerbation. More~     recently, NIV has been shown to significantly improve survival and quality of life in COPD~     patients with chronic stable hypercapnic disease. These data represent an important advance~     in the field, and indicate that usage of NIV in patients with chronic stable hypercapnic~     COPD should increase. Such an increase would be expected to improve patient outcomes and~     have a beneficial impact on the significant healthcare burden incurred by these patients.~     However, the proportion of stable COPD patients with chronic hypercapnia is unknown. In~     addition, using NIV at home to treat COPD patients with hypercapnic (type 2) respiratory~     failure has not often been considered previously and there is a paucity of data regarding~     NIV usage patterns over time in this setting.~   "
18784|NCT02811575|"~     Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is~     difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms~     at the origin of type 2 diabetes and about its complications could make it possible to~     improve the prevention and the treatment of this disease.~      Research team developped a new research axis : the microbiota of the intestinal mucosa. They~     proved a translocation process of intestinal bacteria from the intestinal mucosa to~     different tissue of the organism implicated in glucose homeostasis. This mechanism is~     involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive~     biomarkers of diabetes and obesity is ongoing.~      In parallel, the same team explored the role of intestinal immunity modifications in the~     bacteria translocation from the gut to the blood circulation. They already have some results~     on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T~     CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria~     and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal~     obesity development and type 2 diabetes.~      The aim of this study is to explore this hypothesis in human to have therapeutic solution~     later.~   "
18785|NCT02811562|"~     Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an~     important part of training in various medical and surgical specialties such as~     anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been~     shown that there is a wide variation in the learning curves of residents and the number of~     attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use~     of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good~     alternative. So, the aim of this study is to compare the number of attempt to achieve~     proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.~   "
18786|NCT02811549|"~     The purpose of this feasibility study is to evaluate the benefit of unilateral implantation~     in adults who meet conventional indications for implantation in one ear, but do not meet the~     conventional indications for implantation in the other ear (asymmetric hearing loss) using~     the HiResolution Bionic Ear System.~   "
18787|NCT02811536|"~     Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases~   "
18835|NCT02810847|"~     Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally~     normal but the vision fails to develop correctly. Around half of these children also have a~     squint (strabismus) where each eye has a different direction of gaze. This condition is the~     commonest cause of visual impairment in one eye in children.~      This is a randomised control trial of wearing glasses alone (which will result in some~     visual improvement, termed refractive adaptation) and wearing glasses combined with using~     I-BiT Plus.~      The hypothesis is that using I-BiT Plus will result in an improved visual outcome.~   "
18895|NCT02809963|"~     The aim of this study is to investigate the effect of selective blocking of the~     mineralocorticoid receptor in patients with type 2 diabetes on insulin resistance, lipid~     metabolism and myocardial function.~   "
18788|NCT02811523|"~     Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery,~     most patients will not be cured and will die from their disease, probably because of small~     cancer cells that are present in the lungs at the time of surgery, but cannot be seen or~     detected. It is for this reason that we are looking for a better treatment. Giving~     chemotherapy after surgery is generally not recommended because it has significant side~     effects and no benefit has been proven.~      This study is investigating a new technique for delivering chemotherapy directly into the~     lungs at the time of surgery. Delivering chemotherapy directly to the lungs could~     potentially kill any microscopic cancer cells that are present in the lungs at the time of~     surgery, while sparing other major organs in the body from the side effects of chemotherapy.~     This technique is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized,~     dose escalation study that will act as a pilot study for a larger prospective, multicenter,~     controlled clinical trial. Patients who have bilateral disease will have one lung undergo~     IVLP and the other lung will remain untreated with the IVLP (the other lung will be treated~     as current standard of care - either surgery or radiation) as a control lung. The patients~     will undergo a posterolateral thoracotomy. Lung metastases will be identified by~     visualization or palpation. After surgical isolation of the lung by proximal control of~     pulmonary artery and veins, IVLP will be initiated. After 3 hours of IVLP, the lung~     metastases will be removed in the usual fashion. Patients will be cared for post-surgery~     according to institutional standards. The patients will be followed for up to 2 years. The~     primary endpoint is safety. Secondary endpoints include additional safety endpoints and~     efficacy.~   "
18789|NCT02811510|"~     The purpose of the study is to characterize the acute effects of cannabinoids in women~     relative to men and to begin probing the mechanisms that may underlie gender differences.~   "
18790|NCT02811497|"~     This is a phase 2 study of investigational drug, durvalumab given in combination with~     azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor~     activity of azacitidine in combination with durvalumab patients with microsatellite stable~     colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II~     (PR-OC), and estrogen receptor positive and HER2 negative breast cancer.~   "
18791|NCT02811484|"~     The purpose of this study is to see what the effects of using one or two additional diabetes~     drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking~     insulin. This research study is being done to investigate which of these commonly-used~     medications, medication combinations or increasing insulin dose is better.~   "
18792|NCT02811458|"~     Anxiety disorders are the most common mental disorders in community settings, and they are~     associated with significant psychological distress, functional and social impairment.~     Although pharmacological and psychological treatments for anxiety and depression have~     existed for several years now, only a minority of anxiety disorder sufferers are treated~     according to guidelines. Cognitive behavior therapy (CBT) is the most consistently~     efficacious psychological treatment for anxiety disorders, but implementation of CBT in~     primary care is challenging due to limited resources. Recent studies indicate that~     transdiagnostic group CBT for multiple anxiety disorders could be a promising alternative to~     individual CBT in primary care. The aim of the study is to examine the effectiveness of~     group CBT for anxiety disorders as a complement to usual care. The clinical trial will be~     conducted in three Health and Social Services Centers in the province of Québec (i.e.~     Sherbrooke, Laval and Québec). Patients will be French-speaking adults with anxiety~     disorders, and they will be randomly assigned to one of two treatment conditions: a)~     Transdiagnostic group CBT (12 weekly 2-hour sessions), b) usual care. The transdiagnostic~     group CBT will be offered as a differed intervention to participants in the usual care group~     after the 12-month follow up. Participants in both study arms will undergo a baseline~     clinical evaluation as well as outcome assessment interviews at 4, 8, 12, and 16 month~     follow-up time-points. The primary study results will include improvement on a questionnaire~     on anxiety symptoms. Widespread implementation of group CBT could lead to better outcomes~     for a large number of patients living with anxiety.~   "
18793|NCT02811445|"~     I recently published significant associations between circulating gut bacteria-related~     metabolites with lean and skeletal muscle mass and with measures of physical function in~     older adults, evidence that suggests a role for gut bacteria on the maintenance of these~     outcomes. To date, studies aimed at identification of associations between gut bacteria with~     lean mass or with specific measures of physical function have yet to be reported.~     Accordingly, my over-arching hypothesis is that is gut bacteria are associated with and are~     causatively involved in mechanisms that underlie the maintenance of lean mass and physical~     function in older adults. Results obtained from the proposed study are intended as the basis~     for future studies aimed at targeted modulation of the gut microflora, which may be a novel~     and innovative means for improving lean mass and physical function and for addressing the~     public health priority of healthy aging in older adults.~   "
18794|NCT02811432|"~     There is uncertainty in the effect of KMC in unstable babies and there is a lack of evidence~     to guide how stable an infant must be to gain a mortality benefit from KMC. There is~     therefore, a need for a well-designed RCT that initiates KMC within 48 hours after birth to~     examine the effect on mortality versus conventional incubator care in infants weighing~     ≤2000g who are considered by the responsible clinician to be unstable. We propose such a~     parallel group RCT to be conducted at Jinja Hospital, a resource-limited regional referral~     facility in eastern Uganda.~   "
18795|NCT02811419|"~     This study is a randomized controlled trial to determine whether i-scan can improve the~     detection of conventional adenomas and sessile serrated adenomas/polyps.~   "
18836|NCT02810834|"~     The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two~     innovative school-based physical activity programs (a walking/running program and a~     classroom activity break program) will increase school-time and total daily minutes children~     engage in moderate-to-vigorous physical activity, relative to controls, and that children~     who attend schools with these PA programs will demonstrate improved cognitive functioning,~     academic achievement, and attendance, relative to controls.~   "
19086|NCT02807441|"~     The investigators would like to further the current understanding of aspirin and its effects~     on perioperative bleeding by conducting a randomized controlled trial of spinal surgery~     patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators~     hypothesize that there will be no significant difference in perioperative blood loss between~     the different groups.~   "
18796|NCT02811406|"~     Aims: To compare the rates of hypotension in patients with malignancy-related ascites~     undergoing abdominal paracentesis with and without prophylactic intravenous albumin infusion~      Methodology: Patients with symptomatic ascites secondary to underlying malignancy admitted~     to medical oncology inpatient service who require abdominal paracentesis will be enrolled.~     Patients with known portal hypertension based on SAAG (>11.1 mmol/L) will be excluded.~     Eligible patients are randomized 1:1 to two groups. During drainage of ascites fluid, one~     group will receive intravenous albumin infusion (50 ml/Litre of ascitic fluid drained),~     whereas the other group will not receive intravenous albumin infusion. Baseline parameters~     along with routine 4 hourly monitoring of blood pressure will be done. Episodes of~     hypotension (fall in SBP > 20 mmHg) will be compared between these two groups and~     significance tested using the chi-square test.~      Clinical significance: Ascites often occurs in the setting of advanced malignancy and~     drainage of ascites has been proven to provide symptomatic relief in this patient population~     with relatively short life expectancy. The use of intravenous albumin infusion is loosely~     extrapolated from studies in patients with liver cirrhosis undergoing abdominal~     paracentesis. To date, there have been no standard guidelines to guide practice and no~     studies looking at the use of intravenous albumin in this population. As the mechanisms of~     ascites are different in different malignancies, the indication of intravenous albumin is~     uncertain and perhaps unnecessary in this setting. We hope to understand more about the~     rates of hypotension during abdominal paracentesis in this population and to generate~     systematic data to guide clinical practice in this area.~   "
18797|NCT02811393|"~     The purpose of this study is to assess muscle function in women at least two years after~     being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group~   "
18798|NCT02811380|"~     The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and~     performance and compare it to corresponding standard uncoated CVC.~   "
18799|NCT02811315|"~     The objective of the study is to evaluate the effect of frequency of use with a spacer on~     asthma control in Dutch patients with asthma during their daily clinical practice over 12~     weeks treatment.~   "
18800|NCT02811302|"~     PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary~     objective of this study is to derive a score to identify subjects at risk to have~     respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital~     ward and monitored by capnography. The score will be derived by using subjects within the~     derivation cohort and internally validated using subjects within the validation cohort.~      The primary endpoint used to derive the score will be the occurrence of RD episodes derived~     by Capnostream 20p device memory data combined with clinical data and validated by an~     independent Clinical Endpoint Committee (CEC) during the study course.~   "
18801|NCT02811289|"~     Lean tissue intracellular triglycerides (ICTG) accretion is an important marker of lean~     tissue lipotoxicity that significantly contributes to the development of type 2 diabetes~     (T2D). The mechanisms leading to excess exposure of lean tissues to fatty acids involve~     metabolic dysfunctions of adipose tissues and lean tissues themselves. Understanding the~     role of white and brown adipose tissue in this metabolic dysfunction is particularly~     important in predicting, preventing and treating T2D and many of its associated~     cardiovascular complications.~      A recent breakthrough has been the demonstration that the acute oral administration of a β3~     adrenergic agonist, mirabegron (200 mg), significantly increases BAT glucose uptake in~     healthy individuals. This suggests that mirabegron could be used as a pharmacological tool~     to selectively activate BAT metabolism as part of the mechanistic studies on BAT. It also~     suggests that mirabegron could be used pharmacologically for chronic activation of BAT in~     clinical trials to treat obesity and T2D. However, there are some outstanding issues~     regarding the use of mirabegron to activate BAT. First, there has been no direct comparison~     of the effect of acute cold vs. mirabegron on BAT metabolism. Second, there has been no~     demonstration of the effect of mirabegron on BAT oxidative metabolism since glucose uptake~     is only a surrogate of BAT energy expenditure. Third, acute administration of mirabegron led~     to significant increases in blood pressure and cardiac work, suggesting that it may also~     enhance energy expenditure in other organs in addition to BAT, thus confounding the role of~     BAT in energy homeostasis. Therefore, much remains to be known about the effect of~     mirabegron on BAT and cardiac energy metabolism before this drug can be used as a selective~     activator of BAT oxidative metabolism. The purpose of this study is to directly compare BAT~     oxidative metabolism under cold vs. β3-adrenergic agonist stimulation in lean healthy~     individuals. The investigator hypothesizes that the acute oral administration of a lower~     dose of mirabegron (50 mg) will result in an increase in BAT oxidative metabolism and~     whole-body energy expenditure, to a similar extent as cold exposure, without influencing the~     cardiovascular responses previously seen with the higher dose (200 mg).~   "
18802|NCT02811276|"~     In the 19th century, researchers found out that the differences in the energy content of~     macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount~     of calories individuals burn per day. It was demonstrated that protein has a metabolic~     advantage when compared to the other macronutrients (carbohydrate and fat). Since these~     findings, researchers all over the world started to study how diets differing in~     macronutrient distribution could result in different responses to energy metabolism. Diets~     with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming~     more popular, and studies have shown that when people eat high quantities of protein they~     lose weight and fat mass, maintain the weight loss, and burn more calories per day.~      The investigators hypothesize that giving high amounts of protein to healthy women will~     increase the amount of calories and fat they burn per day, increase their satiety, and~     improve health markers when compared to a normal diet. The increased protein level will be~     achieved using a nutrition supplement consisted of soy protein, yogurt and honey.~      To test this, the investigators plan to divide the participants in two groups: one will eat~     a normal diet and the other a diet with high amounts of protein during one and a half day.~     After one month they will change groups and eat the other diet for the same period of time.~     During this period consuming the diets (1.5 days), participants will stay inside a whole~     body calorimetry suite, which is similar to a hotel bedroom and is able to inform in the~     most precise way the amount of calories participants will burn and if they are burning more~     fat. Additionally, before and after each meal participants will have to answer a~     questionnaire about their appetite sensations and blood will also be collected to analyze~     health markers.~   "
18803|NCT02811263|"~     Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen~     to the brain near the time of birth. This results in death or neurologic disabilities~     including cerebral palsy and cognitive impairment in up to half of affected infants. This~     clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual~     therapy) will improve outcomes for infants suffering from HIE.~   "
18837|NCT02810821|"~     Deficiency in gonadal hormone has been considered to play a role in ageing related increased~     incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the~     other hand, the dramatic increase in gonadotropin level didn't drew much attention when~     talking about the increased risk of cardiovascular disease during menopausal transition.~     This study aim to investigate the association between gonadal hormone, gonadotropin and~     long-term cardiovascular events.~   "
18838|NCT02810808|"~     The study will evaluate the efficacy and safety of two different dosing regimens of~     ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study~     is to provide long-term safety data in the treatment of Chinese patients with wet AMD.~   "
18839|NCT02810795|"~     The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection~     of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients~     with suspected or known CAD clinically referred for invasive angiography.~   "
18804|NCT02811250|"~     Stereotactic radiotherapy is a technique that allows the delivery of a high dose of~     radiation over few fractions (3-6) with great precision. It thus allows tumor ablation and~     optimal preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung~     cancers this technique it gives results very close and or even equivalent to those of~     surgery.~      Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of~     radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall~     et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors.~     In Cleveland (USA) two phase I studies are already underway.~      The investigators propose to develop a phase I study for tumors of less than 4 cm. As found~     in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4~     to 5 fractions) method for the treatment of renal cancers with a high rate of local control.~      The primary objective is to define the maximal tolerated dose for one fraction in~     stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:~        -  Step 1: 4 x 8 Gy.~        -  Step 2: 5 x 8 Gy.~        -  Step 3: 4 x 10 Gy.~        -  Step 4: 4 x 12 Gy.~      The patients will be followed during treatment with evaluation of acute toxicities before~     each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6~     months for a total duration of 5 years after treatment.~   "
18805|NCT02811237|"~     Several studies have demonstrated the possibility of outpatient management or early~     discharge for certain patients presenting acute pulmonary embolism (PE), providing a~     suitable structure is in place.~      The approach featured in the most recent guidelines on acute PE of the European Society of~     Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism~     Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into~     account demographics (age), patient history (cancer, cardiac or respiratory disease), and~     clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is~     offered to low-risk patients, providing that all the conditions pertaining to start~     anticoagulant treatment and follow-up at home are met.~      An alternative approach based on a list of simple criteria has been developed as the one~     used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of~     the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage,~     renal or liver failure, or other medical or social conditions requiring hospitalization.~      The investigators hereby propose comparing these two approaches in an open-label, controlled~     randomized international trial with blinded adjudication of endpoints.~      The main objective is to demonstrate, in normotensive PE patients, that a strategy based on~     the HESTIA rule compared to a strategy based on the simplified PESI score is at least as~     safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).~      The major secondary objectives are to demonstrate, in normotensive PE patients, that a~     strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score~     is more effective :~        -  As regards the rate of patients eventually managed as outpatients.~        -  As regards the rate of patients, in theory, eligible for outpatient care,~   "
18806|NCT02811224|"~     This is a prospective, gold standard observational trial designed to enroll consecutive,~     consenting ovarian cancer patients for the purpose of determining sensitivity of an assay~     that detects circulating tumor DNA. This observational pilot trial will also be used to~     examine the genetic variants/mutations present in the tumor tissue DNA.~   "
18807|NCT02811211|"~     This noninterventional study will assess genomic changes in the metabotropic glutamate~     receptor (mGluR) network in children and adolescents with ADHD.~   "
18808|NCT02811198|"~     The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by~     measuring the hedonic spectrum (pain and reward responsivity), attention and its~     associated brain structures using brain scans (fMRI and DTI), as well as the stability of~     markers over time.~   "
18809|NCT02811185|"~     This is a single-centre, open-label, non-randomized clinical trial designed to monitor the~     occurrence of adverse events associated with [F-18]-FDG Injection manufactured by the~     Fedoruk Centre. [F-18]-FDG Injection used in this clinical trial will be identical to~     commercial [F-18]-FDG that is already used at Royal University Hospital (RUH).~   "
18810|NCT02811172|"~     Background Despite of advances in research, at the moment, various points related to the~     physiology of gestation and the etiology of severe diseases that can be developed in the~     course of it remain unknown. One of those aspects is the behavior of biomarkers~     (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a~     gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few~     days before delivery. Several studies have reported that biomarkers experience a higher~     elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia.~     The description of their behavior in different population of pregnant women (healthy women~     and women at risk) would identify the relation of these with some of the alterations that~     occurs more frequently during pregnancy.~      Objective The aim of this study is to develop a multi-paradigm biological model of systems~     to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and~     its relation with lactogenesis in healthy and risk pregnant women.~      Methods A prospective cohort study will take place with women during pregnancy and~     lactation. Participating women will be divided into two groups. One group will be integrated~     by healthy women and the other group by pregnant women with a risk medical history. The~     personal, family and a detailed medical history will be collected in each group. A study of~     all the variables which influence the level of the mentioned biomarkers (triglycerides,~     cholesterol, glucose and prolactin) will be done.~      The universe consists in 4,300 women, who constitute the historical average deliveries~     during the semester in the city of Granada (Spain). The sample collection will be made in~     medical office's pregnancy control in Granada's hospitals, in their respective health~     centers and during the second half of 2015. The sample will be stratified and probabilistic.~     Peculiarities of pregnant women will be taken into account when calculating the size of the~     study sample. This sample will be made up of 224 women who comply with the inclusion~     criteria and that have signed the informed consent.~      To achieve the project objectives an organization comprising six theoretical and practical~     phases enabling the scientific development of the project.~      During the first phase, the technical and administrative preparation of the project is~     constructed. Thereafter, the work is divided into two action areas which encompass the~     collection and data modeling.~      The creation of a biological multi-paradigm computer simulation model of the levels of~     biomarkers in different months of pregnancy and in the various pathologies of pregnant women~     can be very effective to know the risks that involve high levels of lipids for the mother~     and for the baby.~   "
18811|NCT02811159|"~     To determine the safety of extended treatment with Proellex in women who have successfully~     completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.~   "
18812|NCT02811146|"~     The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation~     programs, improvement of exercise tolerance, with consequent reflection in functional~     capacity and quality of life of this population.~   "
18813|NCT02811133|"~     This is an open trial which seeks to determine safety and tolerability of using inositol for~     children and adolescents with bipolar disorder and comorbid anxiety disorders with~     exploration of efficacy and dose response.~   "
18840|NCT02810782|"~     Three different drugs are used in a randomised, double blind, clinical multi-centre trial~     with three arms. Major objective is to investigate the duration of drug treatment based on~     the Finnegan score. Secondary objectives are to document weight gain, the need for adding a~     second drug when the first drug is not effective enough and possible side effects such as~     convulsions.~   "
18896|NCT02809950|"~     Many patients receiving opioid based analgesia after spinal surgery experience postoperative~     nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents.~     Dehydration caused by fasting prior to surgery is associated with the development of PONV.~     The aim of this study is to investigate the effect of oral carbohydrates loading prior to~     surgery in patients at high risk of PONV undergoing spinal surgery.~   "
18814|NCT02811120|"~     A previous cohort of 93 clinical trial participants received quadrivalent meningococcal~     conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine~     also contains components of diphtheria and tetanus which are linked to the meningitis~     components, in a process called conjugation, to improve their effectiveness.~      Participants are now aged 19-25 and will be invited to take part in this study, which will~     assess antibody persistence over time. This will provide information about the duration of~     protection by relating current antibody levels to those measured in the previous study, and~     will underpin the national immunisation schedule in providing optimal immunisation schedule.~     As well as the meningitis antibodies the investigators will assess diphtheria and tetanus~     antibody levels.~      The study will involve a single blood test of up to 8mL. Participants will be informed of~     their results and any with an antibody level that does not infer protection against strain W~     will be offered an extra dose of vaccine as part of a duty of care.~      The study will involve a single blood test of up to 8mL. Participants will be informed of~     their results and any with an antibody level that does not infer protection against strain W~     will be offered an extra dose of vaccine.~   "
18815|NCT02811107|"~     Anxiety is associated with discomfort but also with an increased risk of pain and/or~     analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic~     consultation but without considering the real anxiety level of the patients. The objective~     of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to~     improve patient cooperation.~      According to a study conducted in the 1990s, 40 to 80% of patients are anxious before~     surgery.~      Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling~     asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and~     postoperative pain.~      Preoperative area is a place of convergence for patients who need surgery or an~     interventional procedure.~      Staying in the preoperative area may be a source of anxiety and may affect the patient~     management.~      The investigators will interview patients undergoing surgery or interventional procedure to~     assess their level of anxiety, pain and their experiences during their stay in preoperative~     area. The objective is to analyse the level of anxiety and / or pain and their clinical~     consequences, and then to assess the relationship with any potential premedication.~   "
18816|NCT02811094|"~     We aim to determine the accuracy or blood transcriptomic signatures to predict the~     occurrence of flares in patients with SLE that are clinically quiescent at inclusion~     Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with~     possible organ damage, and periods of remission. Current biological markers of disease~     activity are not sufficient to predict the occurrence of flares, monitor response to~     treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood~     transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified~     gene panels associated with SLE disease activity~   "
18817|NCT02811081|"~     The aim of this clinical trial is to estimate the efficacy and safety of combined~     intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment~     maneuver for reducing post-laparoscopic shoulder pain.~   "
18818|NCT02811068|"~     HPV vaccines have been included in the national immunisation schedule since 2008, firstly as~     the Cervarix vaccine which protects against two HPV types and in 2012 as the Gardasil~     vaccine which offers protection against a further two HPV types. This study will assess~     whether booster doses are indicated to protect females throughout their lifetime or if the~     vaccinations offered in early adolescence provide this by following up a cohort from a~     previous study where female adolescents were vaccinated 5-7 years ago.~   "
18819|NCT02811055|"~     Aldosterone regulation is mediated by hormonal control, and nervous control. Autonomic~     nervous system action could be mediated by neuropeptides in the adrenal gland. Therefore, in~     pathological conditions and especially in diabetes, low-renin hypertension with normal or~     high plasma aldosterone could be caused by sympathetic nervous system hypertonia.~      Data from the literature and previous in vitro research conducted in the investigators'~     laboratory (INSERM U982, University of Rouen) suggest that adrenal corticosteroid secretion~     might be controlled by sympathetic nervous system. This neurocrine regulation of~     corticosteroid secretion involves locally released neuropeptides. Among them, substance P is~     able to stimulate aldosterone and cortisol production via NK1 receptors. A previous clinical~     trial conducted at the University Hospital of Rouen, APHOS (NCT00977223) studied the effects~     of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy~     volunteers.~      The aim of the present study is to investigate the effects of a NK1 receptor antagonist,~     aprepitant, on adrenocortical secretions in volunteers with diabetes associated with~     low-renin hypertension. Aprepitant is a drug already available for the treatment of nausea~     induced by chemotherapy.~      In the present phase II trial, plasma aldosterone and cortisol levels will be measured under~     treatment with aprepitant versus placebo, in both basal conditions and after activation of~     the adrenocortical function by upright posture. All volunteers will be given the two~     substances (aprepitant and placebo) in a random order during two 14 day-periods separated by~     a 21 day-wash-out.~      This study should allow to determine the role of substance P in the control of~     corticosteroid production in human with diabetes, associated with a low-renin hypertension.~   "
18820|NCT02811042|"~     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic~     position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in~     non-paralyzed anaesthetized pediatric patients.~   "
18841|NCT02810769|"~     The first study of my PhD showed that acute supplementation of berry extracts can modulate~     cognitive behaviour in healthy adults. There is a growing body of evidence supporting an~     improvement in memory and learning performance in animal models following the ingestion of~     flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However,~     study 2, showed no effect on any aspects of memory in healthy young adults after~     supplementation of the berry extracts. It is hypothesised that the lack of behavioural~     effects on memory of the berry juice in study 2 was because of the cohort used. These~     healthy adult participants were already performing near to their peak (Salthouse et al.,~     2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle~     cognitive benefits.~      The aims of the study are to examine if acute supplementation of two berry extracts in an~     older population can augment memory, attention and executive function. Secondly, the time~     course of these behavioural effects will be measured by multiple cognitive assessments~     throughout the day after consumption of the extracts.~   "
18821|NCT02811029|"~     A total of 40% of neurodevelopmental difficulties have been reported in very premature~     infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of~     cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties~     and an increase in school failure.~      Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders,~     executive function disorders as well as attention and behaviour disorders. Developmental~     language disorders have been rarely reported in the literature. This originally prompted our~     request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol~     has studied the language development of children who were born very prematurely, aged 3 and~     a half years free of cerebral palsy, in particular the impact of a short rehabilitation~     period, precise, at an early stage, and protocolized on a fundamental sensorimotor language.~     The principal assessment criterion was the measurement of phonology, the cornerstone of oral~     and written language in humans. The aim of the present project is an analysis of the effect~     that this specific language stimulation has on the learning of written language. The~     hypothesis is that a specific work modifying various aspects of a child's language, during~     the age of 3 to 4, alters the development of phonological skills in a sustainable way. The~     acquisition of reading skills is basically dependent on the quality of its phonological~     components. The randomized study of children up to 8 years of age in a cohort of 150~     children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing~     difficulties have been reported as regards the language understanding of 3 to 15 year old~     children. It is as if the initial difficulties and weaknesses, which moreover constituted~     oral language, prevented the use or development of neural networks, which became more~     complex and required both an oral and written language. Are these elements which constitute~     phonology, at an early stage, modifiable before the close of the clinically measurable~     developmental window?~   "
18822|NCT02811016|"~     The primary objective of the study is to investigate the effect of inhaled budesonide on the~     incidence of AMS. The primary study question to ask is:~      1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559~     m?~      In addition, the secondary study questions to ask are:~        1. Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to~          4559 m?~        2. Are the effects of inhaled budesonide on AMS incidence and severity related to its~          plasma concentration?~      Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg)~     versus placebo~      Study design~        -  Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m~          [Capanna Regina Margherita (Margherita Hut), Italy]~        -  With regard to the intervention (inhaled budesonide) double-blinded and randomized~   "
18823|NCT02811003|"~     To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation~     Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of~     insertional Achilles tendonitis.~   "
18824|NCT02810990|"~     The objective of the present study is to evaluate a new drug called bosutinib as it is~     believed that this agent may be able to predict an excellent prognosis in patients that did~     not obtain any benefit with other drugs before. Still, this needs to be proved and we hope~     this study is able to do so.~   "
18825|NCT02810977|"~     Anesthesiologists try to avoid complications with significant peri -operative morbidity and~     mortality such as bronchoaspiration in patients requiring a surgical procedure under~     anesthesia. Currently, this is achieved based on experts recommendations from the American~     Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment~     of gastric content and volume. This tool allows to individualize each patient and base the~     decisions objectively. The investigators will assess gastric content and volume by~     ultrasound in patients who have fasted and require surgery at two University Hospitals.~   "
18826|NCT02810964|"~     The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a~     placebo will reduce symptoms of schizophrenia when used in addition to standard~     antipsychotic medications.~   "
18827|NCT02810951|"~     The purpose of this study is to evaluate the safety of FCX-007, evaluate C7 expression and~     the presence of anchoring fibrils resulting from FCX-007 and to analyze wound healing as a~     result of FCX-007 administration in subjects with RDEB.~   "
18828|NCT02810938|"~     -  Prospective Atrial Flutter Ablation Registry investigating IntellaTip Mifi XP 8 mm~          technology and MVG isthmus ablation approach~        -  Design: National, multi-centre, prospective observational registry documenting right~          atrial isthmus ablation~        -  Observational treatment: Combination of MVG ablation strategy and the IntellaTip Mifi~          XP 8 mm sensor technology~        -  Duration: Patients will be followed for 6 months post-ablation~   "
18829|NCT02810925|"~     The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and~     a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients~     undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and~     following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4).~     Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.~   "
18830|NCT02810912|"~     Gastric regurgitation increases the risk of pulmonary aspiration in surgical patients~     receiving general anesthesia because of depression of gastro-esophageal reflux. In addition,~     some patients may have higher risk of aspiration as a result of reduced gastric emptying and~     gastroesophageal reflux, prolonged surgical time, and laparoscopic surgery.~     Second-generation supraglottic airway device (SAD) provides an additional channel to~     facilitate the drainage the gastric content to prevent from aspiration, which was routinely~     used in surgeries. Currently, multichannel intraluminal impedance-pH (MII-pH) monitoring,~     which combines multiple impedance channels to conventional pH catheters, is regarded as the~     most sensitive technique for detecting reflux events. Therefore, application of MII-pH~     monitoring on the SAD-based general anesthesia may help to detect ongoing~     reflux/regurgitation in the esophagus of patients during perioperative period. The~     hypothesis of the present study is that the occurrences of gastroesophageal regurgitation~     during general anesthesia may be influenced by the several factors, such as abdominal~     insufflation during laparoscopy, longer surgical time, Trendelenburg position, higher body~     weight, etc.~   "
18831|NCT02810899|"~     The purpose of this randomized, double-blind and placebo-controlled pilot study is to~     investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can~     decrease the harmful effects of anesthesia and surgery on intelligence development in~     pediatric patients undergoing craniotomy.~   "
18832|NCT02810886|"~     Single arm, phase II exploratory trial to prospectively evaluate the impact of~     68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent~     prostate cancer and negative, equivocal or oligometastatic disease after routine imaging~     diagnostic work-up.~   "
18833|NCT02810873|"~     This clinical trial studies positron emission tomography imaging in using copper Cu 64~     TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission~     tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help~     doctors find and diagnose breast cancer.~   "
18845|NCT02810717|"~     Background:~      Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS)~     holds promise as an effective treatment for treatment resistant depression (TRD). rTMS has~     been linked to neuroplastic changes as shown using magnetic resonance imaging (MRI) and~     positron emission tomography (PET). Alterations in serotonin-1A receptor expression (5-HT1A)~     have been linked to major depression. Moreover, changes in 5-HT1A receptor binding -~     observed after pharmacological treatment, as well as after electroconvulsive therapy - has~     been linked to neuronal adaptations in response to these antidepressant treatments.~      Objectives of the study:~      Here, the aim is to investigate the effects of TBS over left and right dorsolateral~     prefrontal cortex on the 5-HT1A receptor binding in patients with TRD using PET. In~     addition, effects of iTBS on brain structure and function will be determined using~     functional, structural and perfusion MRI.~      Study population:~      80 patients with TRD who maintain their original medication regimen will be recruited.~      Study design:~      Longitudinal, randomized and double-blind clinical trial. 40 patients will receive active~     TBS, 40 patients will receive sham TBS for treatment duration of three weeks. Before and~     after three weeks of treatment, patients will be scanned using MRI and PET with the highly~     specific and selective radiotracer [carbonyl-11C]WAY100635. A follow-up visit and final~     examination will be performed 2 and 4 weeks after treatment for the active TBS group,~     respectively. Patients in the sham TBS arm will receive active TBS treatment immediately~     after the second MRI and PET scan.~      Relevance and implications of the study:~      This will be the worldwide first multimodal imaging study to investigate the effects of TBS~     on serotonin-1A receptor binding in TRD using PET. Thus, the study will add crucial~     knowledge to the existing literature on the effects of TMS on brain structure and function,~     related to antidepressant efficacy. Moreover, by combining molecular imaging of serotonergic~     neurotransmission with structural and functional MRI, the proposed study will increase the~     investigators knowledge on the serotonergic role in shaping brain morphology, microstructure~     and structural/functional connectivity. Taken together, the study has the potential to~     contribute to the development of personalized treatment, the reduction of personal suffering~     and the reduction of costs and occupational disability.~   "
18846|NCT02810704|"~     PEPPER is a randomized study comparing the three most commonly used anticoagulants in North~     America in patients who have elected to undergo primary or revision hip or knee joint~     replacement surgery. The anticoagulants being compared are enteric coated aspirin, low~     intensity warfarin, and rivaroxaban.~   "
18847|NCT02810691|"~     With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi~     systemic disease, continue to evolve. A major emerging complication is CF related diabetes~     (CFRD) which is occurring in 40-50% of adults. Patients who develop CFRD are at increase~     risk of morbidity and mortality and they are also facing an increased medical burden with~     insulin therapy, the only recommended treatment. Accelerated decline in weight and/or~     pulmonary function start 2 to 4 years before CFRD onset and this period is characterized by~     frequent Post-Prandial Glycemic (PPG) excursions. Higher PPG excursions are associated with~     lower pulmonary function and it predicts future CFRD risk. To the improved nutritional~     status, lung function and survival of patients, the nutritional approach for patients with~     CF focuses on high-energy high-fat diet and a pancreatic enzyme supplementation. However,~     such diet also contributes to increased PPG excursions. Based on the beneficial effects of~     nutrition therapy to improve PPG in other forms of pre-diabetes and diabetes, extending such~     benefits to patients with CF is important. The investigators aim to test the feasibility and~     the effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF.~     Using a randomized crossover design, the investigators will study the impact of two doses of~     a viscous fiber supplement as compared to a placebo.~   "
18848|NCT02810678|"~     The study is a pragmatic cluster randomized trial that is being conducted in 6 countries,~     with sites in 4 cities in Canada, Benin, Brazil, Ghana, Indonesia and Vietnam. The trial~     tests a complex intervention-a two phase programmatic public health package which includes a~     standardized public health evaluation and analysis, to identify problems and barriers~     limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of~     active Tuberculosis cases. This will be followed by implementation of appropriate solutions.~     The primary objective of the study is to increase the proportion starting Latent~     Tuberculosis Infection treatment among household contacts of patients with active pulmonary.~     A secondary objective is to evaluate the cost effectiveness of this two phase intervention.~     If successful, this approach can be expanded throughout these countries. After initial~     preparations, including administrative and ethical review, all participating sites will be~     randomized to intervention or control. Immediately after this, Phase 1 will begin in~     intervention sties with the standardized public health evaluation to identify barriers to~     LTBI diagnosis and treatment initiation and the selection of solutions to be used in Phase~     2. To ensure standardization of data gathering research staff will use (i) current~     indicators of the Latent Tuberculosis Infection cascade of care in intervention facilities~     (number of contacts per index case registered, investigated, started on treatment and~     completing treatment) and (ii) interviewer administered questionnaires for patients with~     active pulmonary Tuberculosis, adult and child household contacts and clinic staff. These~     questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from~     the perspective of these different participants. Results from intervention sites in Phase 1~     will be analyzed, and used by the investigators, together with local public health~     officials, to decide on appropriate corrective solutions in each sites. In Phase 2,~     solutions for problems identified will be selected and implemented at the intervention~     sites. Study outcomes and costs will be measured at all intervention and control sites~     throughout Phase 1 & 2. Results will be disseminated within each country through existing~     links with national Tuberculosis programs, and through international organizations such as~     the World Health Organization.~   "
18849|NCT02810665|"~     This is a cross-sectional study to determine the repeatability and concordance of visual~     acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric~     chart in Thai individuals.~   "
18850|NCT02810652|"~     The purpose of this research study is to addresses the challenge of managing the unique~     perioperative needs of older cancer patients undergoing surgical resection.~   "
18851|NCT02810639|"~     Spinal morphine has been widely provided for acute postoperative analgesia. However, the~     analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators~     are interested in the pain characteristics during the 2nd postoperative day. The~     investigators will also explore the regimens for pain therapy in our hospital.~   "
18852|NCT02810626|"~     The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor~     Imaging(DTI) product functionality used in pre-operative planning and intraoperative~     surgical navigation, improves clinical outcomes corresponding to a reduction in neurological~     and neuropsychological deficits in pediatric brain tumor surgery.~   "
18853|NCT02810613|"~     (Bio)medical research, particularly immunological, metabolic, transcriptional or biological~     assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine.~     In order to comply with international guidelines for Good Clinical Practice, the~     investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or~     urine from voluntary donors. Recruitment of volunteers will be a continuous process.~     Volunteers will consent to occasional blood- or urine donation.~   "
18854|NCT02810600|"~     Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE~     injection in patients with suspected or diagnosed with tumors expressing somatostatin~     receptors. Each included patient will receive an administered dose of 50 mcg or less of the~     peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.~      The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous~     studies.~   "
18855|NCT02810587|"~     This is a prospective case series which aims to determine the incidence of endophthalmitis~     following intravitreous anti-vascular endothelial growth factor (VEGF) injection comparing~     between eyes receiving post-injection antibiotics drops and those not receiving antibiotics~     drops treated at Chiang Mai University Hospital between May 2015 and April 2017 (2-year~     period).~   "
18857|NCT02810561|"~     The goal of this study is twofold. First the investigators would like to determine the~     trajectory of troponin leaks; if it can be shown that the participants who have only minimal~     elevations of their repeat troponin universally decrease on the 3rd level then future~     patients may see significantly improved length of stay. Second, given conflicting results in~     the literature, the investigators would like to determine if elevated troponin levels~     correlate to later cardiovascular complications. These complications will be defined as~     Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting~     or bypass). As the investigator is a single hospital system in this county it is uniquely~     positioned to be able to review this retrospectively.~   "
18858|NCT02810548|"~     Background: the ultimate goal of periodontal therapy is the regeneration of periodontal~     tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in~     osseous regeneration in the areas of periodontal surgery.~      Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in~     periodontal intrabony defects.~   "
18859|NCT02810535|"~     The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not~     selected group of young students (n=100-300). Students will be selected by public posting.~     In all students an allergy skin test will be performed. Then the local IgE of 24 subjects~     with non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic~     rhinitis and positive prick test to house dust mite. In addition 20 controlls will be~     investigated. Based on these investigations, the importance of local IgE and the IgE~     spectrum in conjunction with rhinitis should be further clarified.~   "
18860|NCT02810522|"~     This study is to support the regulatory application of OneTouch Select® Plus test strips in~     China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and~     China Food and Drug Administration (CFDA) regulation of IVDs should be complied with. The~     result of this study will be used to support regulatory filing in China.~      Investigational Product:~      OneTouch Select® Plus test strips (test with OneTouch Select® Plus glucose meter)~      Objectives:~        1. Assess Lay User and Health Care Professional (HCP) fingertip test results obtained on~          OneTouch Select® Plus BGMS compared to a validated method (YSI 2300 glucose analyzer~          results), according to International Standards Organization( ISO) 15197:2003(E) section~          8.0 and ISO 15197:2013(E)~        2. Lay User System Use evaluation.~        3. Assess the effectiveness of the instructions for use of OneTouch Select® Plus BGMS~          (Owner's booklet) and insert of test strips for the lay user.~      Comparator(control) Product:~      YSI 2300 glucose analyser~      Acceptance Criteria:~      User Performance of the OneTouch Select® Plus Blood Glucose Monitoring system(described as~     OneTouch Select Plus below) is met if the lay user and HCP results obtained with OneTouch~     Select Plus meet the requirement stated in section 7.4.1 of ISO () 15197:2003(E). Further to~     meet the requirements of ISO 15197:2013(E) , the lay user results obtained with OneTouch~     Select Plus should meet the requirements stated in section 8.2 of ISO 15197:2013(E). The~     effectiveness of instructions for use is met , if for each item on the Instructions for Use~     Questionnaire, the 90% lower confidence limit (90% LCL) for the correct response rate is~     equal to or greater than 70%.~      Study Design and subject population:~      This study is an open, non-randomized clinical evaluation and will be conducted at a minimum~     of 2 sites in China. At least 240 evaluable diabetic subjects who meet the enrolment~     criteria will participate in this evaluation.~      Study procedures:~        1. Each potential Subject (or legally authorized representative) reads and signs the~          Informed Consent Form, and receives a signed copy.~        2. After completing an in-clinic familiarization session, the Subject lances a fingertip,~          obtains a drop of blood large enough for two meter tests, and performs a self-test~          using OneTouch Select Plus BGMS.~        3. Study staff immediately performs a blood glucose test from the same blood drop with a~          second set of OneTouch Select Plus BGMS with the same lot of test strips.~        4. Within 5 minutes of the Subject's self-lancing, study staff collects blood from the~          same finger puncture for hematocrit and reference plasma glucose testing (duplicate~          tests on the YSI 2300 performed by study staff).~   "
18861|NCT02810509|"~     The current study aims to assess the quality of anticoagulation with warfarin in real world~     practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and~     to explore predictors for poor International Normalized Range (INR) control.~   "
18862|NCT02810496|"~     As the investigators observed a case of glucocorticoid mutation revealed by incidentally~     discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular~     anormality could be more frequent than previously described. To validate this hypothesis, it~     was decided to study 150 multicenter consecutive patients, presenting with incidentally~     discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all~     these patients GR gene will be studied, mutations will be detected and described, functional~     disturbance will be tested. Usual polymorphisms will be described. Correlation between~     clinical signs, hormonal and morphological abnormalities and presence or absence of GR~     mutations will be searched.~   "
18863|NCT02810483|"~     There is no specific treatment for core symptoms of PWS. Regarding behavioral and~     psychiatric symptoms (hyperphagia, imulsivity and self-mutilations), one of the only drug~     options consists in antipsychotics, that are not efficient and might be responsible for a~     worsening of the weight gain (major issue in PWS). An alternative therapeutic approach for~     behavioral disturbances has been suggested by some authors with topiramate (Epitomax®), an~     antiepileptic drug that can be used as a mood stabilizer and anti-impulsive. In addition,~     topiramate is used as a treatment for eating disorders because it induces loss of weight and~     appetite. This last effect might be useful in the case of SPW.~      Except for some clinical case reports, the investigators only found one open study for~     topiramate in SPW 8 patientssuggesting promising effects. There si however no placebo~     controlled study..~      Objective:~      To evaluate the efficacy of topiramate (200 mg / d) on Eating disorders (E), self~     Mutilations (M), irritability and Impulsivity (I), metabolic status, and tolerance among of~     PWS patients.~      Methodology:~      This is a multicenter (out-patients in Toulouse, Reims, Nantes and Paris and in-patients in~     Hendaye) 8 weeks double-blind placebo controlled study .~      Subjects (n = 125 for 112 analyzable) all having PWS, aged 12 years-old and more should have~     any of the following symptoms: E, M and U (see above). All subjects will be randomly~     allocated into two groups one taking a placebo, the other taking topiramate (50mg / day~     initially, increasing up to 50mg per week 200mg / day).~      The population of analyzable patients in and out patient will be of equal size (n = 56). The~     inclusion period is two years..~      Are excluded subjects with antipsychotic or mood stabilizer medication or topiramate.~      The primary endpoint will be the rate of responders, with response defined by obtaining a~     score of 1 or 2 on the CGI improvement after 8 weeks of treatment~      Other assessments, secondary endpoints :~        -  Clinic: Weight / Size / Self-injury behavior (french Echelle des Conduites Auto et~          Hétéro Aggressives, ECAHA))~        -  Psychometric: C-SHARP and A-SHARP / Conners (Impulsivity) / Dickens (Eating behavior~          for PWS)~        -  Organic: NFS, serum electrolytes, creatinine, ammonia plasma, serum bicarbonate, AST /~          ALT / GGT, ghrelin, fasting glucose, lipid profile and insulin, leptin, TG and HbA1c.~        -  Side effects of topiramate: SAPS / SANS and BPRS (hallucinations), anxiety scales and~          laboratory tests.~   "
18864|NCT02810470|"~     Malnutrition is a major health problem with serious consequences for the quality of life of~     elderly people: it increases the number of hospitalizations and lengths of stay, worsens~     functional dependency and increases morbidity and mortality rates There are numerous~     recommendations and tools to detect or to manage malnutrition and the prescription of Oral~     Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony,~     as well as age-related changes, which may or may not be associated with the presence of~     disease, it is necessary to ensure full ingestion of the prescribed supplements to optimize~     the benefits provided by these products. To achieve this it is necessary to know the~     chemosensory characteristics of foods enjoyed by hospitalized elderly people who are~     malnourished or at risk of malnutrition. The investigators make the hypothesis that by~     further optimizing taste and energy content of foods, consumption by the elderly and the~     health benefits would be improved.~   "
18867|NCT02810431|"~     Background:~      This protocol is designed to have samples from closing protocols transferred to this~     protocol for long-term storage. The protocol is concerned with the retention of blood,~     plasma, serum, CSF, aspirates, bone marrow, ascites fluid, urine, saliva, PBMCs, skin,~     mucosal, tumor and healthy tissue samples from patients with cancer to support basic science~     and clinical research activities of the Medical Oncology Branch and other intramural~     Laboratories and Branches at the NIH Clinical Research Center and Center for Cancer~     Research.~      Objectives:~      To allow long-term storage of biospecimens collected during prospective clinical trials in~     patients with various cancer phenotypes, as needed to support the research activities of the~     Medical Oncology Branch and other Laboratories and Branches.~      Eligibility:~      Samples eligible for long-term retention must be from those who have signed consent for~     storage and retention of biospecimens.~      Design:~      Acquired samples will be barcoded and associated data will be entered into an encrypted~     computer software system, and securely maintained to protect patient identifiers. Samples~     are retained and made available to the original PI, or other Investigators with the original~     PI's permission, following submission and approval of a supplemental research protocol to~     the IRB or OHSRP.~   "
18868|NCT02810418|"~     Background:~      LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker~     called mesothelin. Mesothelin is found on the surface of many different tumors, including~     pancreatic cancer, but is made by a very small number of normal tissues. After binding to~     the mesothelin on tumors, LMB-100 can attack and kill cancer cells. Researchers want to see~     how well it works when given with nab-paclitaxel, which treats pancreatic cancer.~      Objectives:~      To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people with~     advanced pancreatic cancer. To see how well the combination of the two drugs reduce tumor~     size.~      Eligibility:~      Adults age 18 and older with advanced pancreatic cancer that has worsened after anti-cancer~     therapy.~      Design:~      Participants will be screened with medical history and physical exam. They will give blood,~     urine, and tissue samples. They will have scans and x-rays.~      During each 21-day cycle:~      Participants will get LMB-100 by an IV catheter on days 1, 3, and 5. This is a tube inserted~     in a vein, usually in the arm.~      Participants will get nab-paclitaxel by IV on days 1 and 8.~      They will get this combination for up to 4 cycles or until their disease worsens or they~     have intolerable side effects.~      Participants will have blood and urine tests and scans throughout the study.~      Participants will have a safety follow-up visit 6 weeks after treatment ends. If their~     disease remains stable or improves, they will be scanned every 6 weeks until their disease~     gets worse. Even if their disease gets worse, they or their doctor will be called to talk~     about their cancer status.~   "
18869|NCT02810405|"~     BACKGROUND:~      Cancer of any type is a serious disease and despite all the progress made from past~     research, there is still much that is poorly understood at the molecular level. Recent~     advances in biomedical technology platforms have emerged as critical tools for accelerating~     personalized medicine. The collection of human tissue specimens has been an invaluable~     resource for conducting translational cancer research using these developing technologies.~     The ultimate goal is to understand the molecular indicators of cancer development and~     progression. While it is ideal to be able to study clinical samples, specifically tissue~     biopsies, they are however precious and are often difficult to obtain in sufficient~     quantities or numbers to conduct proteomic or molecular profiling studies. There exists,~     however, a vast archive of pathologically characterized clinical samples in the form of~     formalin-fixed paraffin-embedded tissue blocks. The preservation of these tissue blocks~     and/or slides for long-term (years) storage is an important asset that aids in translational~     and clinical research. This protocol will describe the procedures for receiving, labeling~     and storing paraffin-embedded tissue blocks and/or slides until they are needed for future~     analysis. When blocks are ready for analysis, the requestor will then follow the IRB~     protocol specific to that study.~      OBJECTIVE:~      - To obtain tissue blocks and slides from outside pathology departments for cancer patients~     being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research~     (CCR), National Cancer Institute (NCI) in order to store them for future studies and~     analysis (e.g., using molecular technology platforms).~      ELIGIBILITY:~      - Patients suspected of having, or with biopsy proof of malignant disease will be evaluated~     in the Medical Oncology Branch and Affiliates Clinics, NCI.~      DESIGN:~        -  Tissue blocks and slides will be acquired from outside pathology departments and~          received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.~        -  Bar-coded tissue blocks and slides will then be transferred to the Laboratory of~          Pathology/CCR/NCI for proper long-term storage.~   "
18870|NCT02810392|"~     Almost two-thirds of survivors have cognitive impairment (CI), manifested as memory,~     language, and judgement problems. Post-stroke CI at 2 weeks is a significant predictor of~     long-term functional outcome, and more generally, cognitive impairments have a major impact~     on functional outcome and ability to participate in rehabilitation. CI is associated with~     increased systemic inflammation. Intranasally-administered insulin is a promising new~     therapy for enhancing memory in patients with mild cognitive impairment (MCI) and~     Alzheimer's disease (AD), shown in multiple randomized controlled studies. Likely mechanisms~     of benefit are intranasal insulin's ability to restore normal cerebral insulin signaling.~     Based on the overlap in cerebral insulin resistance that occurs in both AD and post-stroke~     CI, we have designed an innovative proof-of-concept, feasibility trial designed to provide~     pilot data as to whether post-stroke survivor CI and caregiver burden is improved with~     intranasal insulin early after stroke. We will explore the impact of intranasal insulin on~     inflammatory biomarkers, since inflammation is a major underlying cause of CI, as shown by~     others and in our preliminary studies of VCAM-1. Specific Aims are: 1. Determine if patients~     with ischemic stroke randomized to intranasal insulin 20 IU BID for 3 weeks have improved~     cognition, compared to patients who receive intranasal saline. Primary outcome is a~     composite of (a) memory and executive function z scores. 2. To assess the impact of~     intranasal insulin vs saline on change in inflammatory biomarker levels (VCAM-1, TNF-alpha,~     TNFR-I and II) before and after the treatment period. 3. To measure differences in burden~     among caregivers of participants in the intranasal insulin vs intranasal saline groups. We~     will prospectively randomize 40 subjects to intranasal insulin (40 IU) vs saline treatment.~     Following baseline cognitive testing 2 weeks post stroke, subjects will receive the assigned~     treatment for 3 weeks, followed by a 3-week washout period, with cognitive testing performed~     after the treatment and washout periods and again at 20 weeks. The proposed study will~     provide data on a promising method for treating cognitive function in stroke patients. If~     effective, our pilot data will set the stage for larger phase III clinical trials.~   "
18871|NCT02810379|"~     To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined~     with written informed consent provides participants more information about the procedure,~     which can make participants understand the procedure well. Investigators advocate the~     development of institutional and national guidelines to ensure optimal practices of~     acquiring informed consent.~   "
18872|NCT02810366|"~     The objective of this study is to compare the performance of computer-coded verbal autopsies~     (CCVA) to physician-coded verbal autopsies (PCVA) at the population level. In order to do so~     a randomised control trial is being conducted in five districts of India. In each district,~     50% of deaths are randomly selected for PCVA and the rest for CCVA. The cause of death~     distribution for both groups are then compared within each district. If the performance of~     PCVA and CCVA are comparable, the attained distributions should be similar.~   "
18873|NCT02810353|"~     This study evaluates the dentoskeletal effects of the expander with differential opening in~     orthodontic patients in the mixed dentition. Half of participants will undergo rapid~     maxillary expansion (RME) using the expander with differential opening, while the other half~     will undergo RME using the conventional Hyrax expander.~   "
18874|NCT02810340|"~     MCV-5 is a vaccine being studied for use against a germ that causes infections of the brain~     and/or the blood. There are several licensed vaccines that protect against meningitis caused~     by 4 different types of the germ, but there is one type of the germ that these vaccines do~     not protect against. MCV-5 includes the same coverage as these other vaccines and includes a~     fifth type. The purpose of this study is to test how this vaccine affects adult human~     volunteers when compared to a licensed meningitis vaccine. Investigators will monitor~     volunteers for side effects and collect blood to test for antibodies.~   "
18875|NCT02810327|"~     The goal of this study is to better understand why some Alpha-1 genotype MZ (PiMZ)~     individuals develop chronic obstructive pulmonary disease (COPD) while others do not. This~     study will examine portions of the Alpha-1 gene that are not routinely tested to determine~     whether other changes in this gene correlate with development and progression of COPD.~     Participation involves responding to questionnaires about lung health and history, and~     performing an at-home finger stick to obtain blood spots using a test kit that is mailed.~     The blood provided will be used for genetic testing and correlation of results with COPD~     history. Participants will receive their results and access to genetic counseling at the~     conclusion of the study.~   "
18876|NCT02810314|"~     The study will evaluate connectivity regardless whether patients present a clinical type~     that requires medical treatment. In this point, investigators will include patients with~     progressive evolution as well as initial forms of the disease (CIS) and properly established~     forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not~     focus on medical treatment as some of these clinical forms have no indication for disease~     modifying drugs.~   "
18877|NCT02810301|"~     Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten~     sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of~     gluten.~   "
18878|NCT02810197|"~     This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13~     Paris terrorist attacks. Both structural and functional brain imaging data will be collected~     at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in~     control non-exposed participants. This project will capitalize on recent evidence showing~     that healthy participants can prevent unwanted images from entering consciousness using~     inhibitory control and memory suppression techniques, disrupting traces of the memories in~     sensory areas of the brain, and weakening their vividness and later reentrance. This process~     is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized~     by anxiety and persistent intrusive memory of the traumatic event with highly distressing~     contents. This project will thus provide a unique opportunity to observe the online and~     structural dysfunctions of intrusion control network following a severe psychological trauma~     and how such process may contribute to recovery and psychopathological dynamics. In~     addition, the disruption of social cognition and emotional processing following PTSD will~     also be investigated in relation to disrupted inhibitory control functioning.~   "
18879|NCT02810184|"~     Background~      Bone augmentation provides a solution for patients with a severely atrophic jaw to achieve~     immediate fixed prosthetic rehabilitation. Studies reporting total bone volume changes are~     lacking.~      Objectives~      The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36~     months post-surgery in patients who underwent immediate prosthetic rehabilitation through a~     cranial bone-grafted maxilla in combination with immediate provisional implant (IPI)~     placement.~      Study design~      A prospective, longitudinal study.~      All patients will be recruited at time of pre-surgical consultation.~      During the surgical procedure, autogenous cranial graft reconstruction of the jaw is carried~     out under general anaesthesia.~      Cone-beam CT (CBCT) scans (NewTom VGi evo, QR Verona, Italy) will be taken pre-operatively,~     and at different time-points post-operatively to evaluate the remodeling process of the bone~     after the grafting procedure with implant placements and assess the total bone volume~     changes up to 3 years post-surgically.~      CBCT scans will be send to the oral maxillofacial surgery (OMFS) Research Group within the~     Department of Imaging and Pathology (IMPATH), Catholic University Leuven (liaised with the~     clinical department of Oral and Maxillofacial Surgery; University Hospital Leuven) for~     analysis of the total bone volume.~      Data related to patient demographics, clinical diagnosis, the surgical procedure, IPI~     stability, and total bone volume at different time-points will be registered by a clinical~     research coordinator.~      Conclusion~      This prospective trial could add important knowledge to the field, and provide indications~     to improve future clinical pre-prosthetic management.~   "
18880|NCT02810171|"~     Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early~     in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life~     anxiety, but as many as 40% of young patients who receive CBT fail to get better. The~     proposed study will examine brain changes marking positive response to CBT for anxiety and~     how these changes may differ in children compared adolescents. By helping us to understand~     how CBT works, this study will pave the way for new treatments to stop anxiety early.~   "
18881|NCT02810158|"~     To answer the question whether a previously detected breath profile in patients suffering~     from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA~     using mass spectrometry (validation study).~   "
18882|NCT02810145|"~     We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult~     patients (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at~     the Health Sciences Center with a severe TBI will have cerebral oximetry monitoring~     instituted within 12 hours of admission and continuing for 72 hours after placement.~     Decreases in regional cerebral oxygenation will be correlated with ICU hemodynamic~     parameters including mean arterial pressure, intracranial pressure, and arterial oxygen and~     carbon dioxide tension.~   "
18883|NCT02810132|"~     The study evaluates the effects of metformin treatment on myocardial efficiency in heart~     failure patients. 36 patients will be randomized to three months of metformin or placebo~     treatment in addition to their regular therapy.~      Hypothesis: Treatment with metformin in patients with heart failure has direct or indirect~     beneficial effects on left ventricular myocardial oxidative metabolism, myocardial~     efficiency and contractile function.~   "
18884|NCT02810119|"~     A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and~     Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis~   "
18885|NCT02810106|"~     Cardiovascular diseases are important cause of death, and of these have highlighted the~     Coronary Artery Disease (CAD) and its various clinical manifestations. The chest pain~     suggestive of ischemic heart disease is frequent complaint in medical consultations and~     hospitalizations . Complementary tests and images exams for risk stratification as Cardiac~     Stress Test (ET), the Myocardial Perfusion scintigraphy of (SPECT) are established for risk~     stratification and assessment workup in suspected ischemic heart disease. Coronary~     tomography angiography (CTA) has emerged as a robust method for non-invasive assessment of~     CAD, showing data diagnostics that directly correlate with invasive coronary angiography.~     Recently, the Myocardial Perfusion by Tomography Computed (CTP) has emerged as a new~     technique to measure the flow limitation for coronary microcirculation. In clinical~     practice, the exercise testing with electrocardiogram changes compatible with myocardial~     ischemia can lead to other examinations for elucidation of ischemic etiology, the most usual~     myocardial scintigraphy. However, a SPECT without evidence of ischemia, does not explain~     ischemic electrocardiographic changes triggered by physical stress, although it is a good~     marker prognostic. A CTP is a emerging tool in the evaluation of myocardial ischemia. Recent~     studies point to a good accuracy of the method compared to nuclear medicine. To test this~     hypothesis, this study aims to evaluate whether the CTP has a better diagnostic performance~     in detecting of obstructive or not obstructive CAD compared to the SPECT in the population~     of patients with exercise stress testing compatible with myocardial ischemia, and the~     computed tomography angiography (CTA) as the reference method. In addition, data from the~     exercise test (functional capacity, hemodynamics, electrocardiogram changes) will be~     compared to findings of CTA and CTP.~   "
18886|NCT02810093|"~     Primary purpose :~      To develop a method to automatically extract and structure the information included in~     numerous medical records from breast cancer patients.~      Secondary purpose :~      With this procedure we can analyze the content of ten thousand anonymized textual medical~     records.~      This information should enable us to explore many subjects, such as:~        -  The impact of certain therapeutic procedures~        -  The characteristics of sub-groups of patients~        -  Pregnancy associated breast cancers~        -  Risk factors~   "
18887|NCT02810067|"~     Root coverage with acellular dermal matrix using the coronally positioned tunnel technique~     comparing two different donor materials~   "
18888|NCT02810054|"~     After performing the power calculation, healthy adult participants for the study will be~     randomly allocated into two groups. The intervention group will receive minimally invasive~     surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of~     intrabony periodontal defect. The control group will receive minimally invasive surgical~     techniques (MIST) without enamel matrix derivative (Emdogain).~      Clinical attachment level (CAL) gain and periodontal pocket depth (PPD) reduction as well as~     the position of gingival margin (REC) as the main outcomes and the radiographic intrabony~     infill, bleeding on probing (BoP), full mouth plaque score (FMPS) and full mouth bleeding~     score (FMBS) as secondary outcome will be recorded for the participants by 3 examiners at~     three stages:~        1. Before the procedure as a baseline record.~        2. 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.~        3. 12 months after surgery.~      The readings will be recorded using The University of Michigan O Probe with William's~     Calibration OR Pressure Sensitive Periodontal Probe at 0.3 N to the nearest millimeter for~     the clinical attachment level gain (CAL), the periodontal pocket depth (PPD) and the~     position of gingival margin (REC), present or absent for the bleeding on probing (BoP), and~     intra oral periapical (PA) radiograph for crestal bone level assessment.~   "
18889|NCT02810041|"~     Overweight and obesity are public health problems worldwide. Even though heredity may be one~     of the causes the diseases, the vast majority of cases is rather linked to a sedentary~     lifestyle associated or not with a low-variety, high-calorie diet. Many diets and slimming~     methods propose low-calorie meals or physical exercise, and the consequences of these are~     sometimes negative with advancing age (muscle wasting). Certain studies have shown the~     efficacy of foods with antioxidant properties on the reduction of blood pressure, Low~     Density Lipoprotein (LDL)-cholesterol and weight or on the distribution of fat mass-lean~     mass. The investigators put forward the hypothesis that the daily consumption of two~     yoghurts containing XXS, a mixture of natural polyphenolic compounds -rich in quercetin-~     from plant extracts, could lead to weight loss, a better fat mass-lean mass distribution and~     an improvement in markers of oxidative stress in overweight persons aged 50 to 65 years.~   "
18890|NCT02810028|"~     In adults, muscle diseases are usually chronic long-term conditions that do not have a~     definitive cure. Supportive care has been shown to reduce complications from muscle disease~     and improved survival in some cases. However, there has been limited research to evaluate~     interventions that may improve quality of life (QoL) with this patient group. The QoL of~     those with MD is not just affected by the severity of their MD but also a variety of~     psychological variables. Based upon the knowledge of these psychological variables the~     investigators feel that a particular type of psychological intervention known as acceptance~     and commitment therapy (ACT) could potentially improve QoL in those with MD. The~     investigators therefore propose to test whether ACT does in fact improve QoL in those with~     MD by randomising 154 patients to receive either standard medical care plus a guided~     self-help ACT programme, or standard medical care only.~   "
18891|NCT02810015|"~     Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular~     joint (TMJ), masticatory muscles and associated structures. This broad complex of functional~     disorders often affects the face and jaws causing chronic pain, earaches, headaches,~     migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with~     conservative management require surgical intervention. Recently, the use of botulinum toxin~     has proven effective and has the potential to bridge the gap between conservative therapy~     and surgical management resulting in less patients requiring invasive surgery. Objective: We~     aim to treat TMD of muscular origin using Botulinum toxin injections in the trigger points.~     Methods: Patients, whose pain originates from trigger points, will be enrolled in this~     prospective trial. This study will evaluate subjective and objective responses to treatment~     with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be~     injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes~     such as pain and orofacial function on a visual analog scale as well as objective outcomes~     such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and~     masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle~     bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger~     points in these patients to disappear and the associated muscles to become partially~     paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that~     the patient's overall functional ability will increase. We also expect that muscular~     hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their~     cosmetic image positively. Overall, we hope these changes will result in a reduction in pain~     and headaches which will consequently improve the participant's diet, nutrition,~     psychological well being and quality of life.~   "
18892|NCT02810002|"~     One hundred infantry recruits will be randomly assigned to two groups. Injuries will be~     monitored.~   "
18893|NCT02809989|"~     The aim of this non-interventional study is to extend the knowledge on effectiveness of~     Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using~     a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.~   "
18894|NCT02809976|"~     The purpose of this study is to determine if topical ruxolitinib 1.5% will provide~     repigmentation in vitiligo lesions.~   "
18898|NCT02809924|"~     This study compares the use of simulation-based just-in-time training to video training in~     learning neonatal endotracheal intubation. Half of the participants will be trained using~     simulation-based just-in-time training and the other half using video training.~      The hypothesis are~      Primary hypothesis:~      In the Neonatal Intensive Care Unit, use of simulation-based just-in-time training, compared~     to video training, will increase the rate of successful clinical endotracheal intubation by~     20%.~      Secondary hypotheses:~      The investigators expect that simulation-based just-in-time training prior to clinical~     endotracheal intubation will decrease time to successful intubation and rate of endotracheal~     intubation related adverse events, namely mucosal trauma, oesophageal and endobronchial~     intubations. In addition, the investigators expect that simulation-based just-in-time~     training will increase residents' confidence level while performing clinical endotracheal~     intubation.~   "
18899|NCT02809911|"~     Evaluate the effectiveness of the Provant Therapy System compared to sham on pain~     sensitivity and nervous system response to various qualities of experimentally induced pain~     in the upper and lower extremities of subjects with painful peripheral diabetic neuropathy.~   "
18900|NCT02809898|"~     Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of~     biliary tract cancer.~   "
18901|NCT02809885|"~     Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia~     and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype~     found in Europe and North America and is responsible for sporadic infections except for~     travel associated diseases.~      HEV had a principally asymptomatic form. However, it was recently demonstrated that it could~     lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver~     transplanted patients the infection could mimic a rejection and lead to the loss of the~     transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its~     well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack~     of information about the prevalence of this disease.~      In Canada the incidence of HEV infection was high (15-86% for liver transplanted children~     with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney~     transplanted children whereas 7,4% in control. It was shown in a retrospective study that in~     liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.~      This study will determined in a prospective approach the HEV prevalence in kidney, lung,~     heart and bone marrow transplanted children in Lyon.~   "
18902|NCT02809872|"~     The aim of this study is the feasibility assessment of a simple and affordable model for the~     quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will~     be performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the~     effusion in correspondence of the midline of hPEUS (aPEUS). The proposed model will estimate~     the Pleural effusion volume (PEVUS) by multiplying hPEUS and aPEUS. PEVUS will be compared~     with volumes estimated by CT scans (PEVCT), obtained within 24h from the US examination.~   "
18903|NCT02809846|"~     To study effects Quell has on opioid consumption and pain relief in patients with cancer.~   "
18904|NCT02809833|"~     This prospective, multicenter, non-interventional study will enroll participants from~     routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of~     the study is systematic collection of data on use of tocilizumab in daily routine with~     special emphasis on treatment decision by the prescriber, compliance with Summary of Product~     Characteristics (SmPC), and documentation of relevant activity scores and adverse drug~     reactions (ADRs). The maximum observation period will be 12 months per participant.~   "
18905|NCT02809820|"~     The Investigators will test the hypothesis that nonselective beta-blockers would have a more~     pronounced effect on platelet aggregation than selective beta-blockers in patients with~     acute coronary syndrome treated with dual anti platelet therapy.~   "
18906|NCT02809807|"~     Background: The gas mask is used to protect the aiways against respiratory hazards (CBRN~     agents). Within the CBRNE committee, speculations are that unprotected lungs would look like~     to those of COPD patients in post-exposure of some CBRNE agents. The aim of the study was to~     evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory~     effort. Methods: We are completing our study with 9 COPD patients to evaluate breathing~     patterns, index of respiratory efforts and blood gases. Three conditions have been tested in~     a randomized order: 1x baseline and 2x different canisters, with and without a mask (C4,~     Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have~     been measured. An esophageal catheter is introduced at the beginning of the study to measure~     esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2~     is continuously measured and capillary blood bases are drawn at the end of each condition.~     Each condition lasts 10 minutes, data of the last 2 minutes at a steady state are considered~     for analyses. Results. We are compiling data and processing them for analysis.~   "
18907|NCT02809794|"~     The study is to evaluate the product reliability, therapy effectiveness and user feedback of~     a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.~   "
18908|NCT02809781|"~     The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem~     cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the~     therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to~     treat this disease.~   "
18909|NCT02809768|"~     The purpose of this study is to determine the effects of concomitant administration with~     fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose~     of avatrombopag in healthy participants.~   "
18910|NCT02809755|"~     The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG)~     block to prevent shoulder tip pain following primary laparoscopic gastric banding, band~     revision, band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy.~     Shoulder tip pain (STP) is a common problem after laparoscopic surgery, manifesting in the~     post-anesthesia care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic~     analgesics including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not~     reliably relieve STP. This study is designed to determine if the SPG block, a simple and~     low-risk procedure, effectively treats STP after laparoscopic bariatric surgery.~   "
19087|NCT02807428|"~     The objectives of this study are to evaluate the safety and analgesic efficacy of a single~     preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral~     total knee arthroplasty.~   "
18911|NCT02809742|"~     Enhanced patient safety and satisfaction have contributed to growing use of epidural labor~     analgesia. Epidural analgesia appears to be currently the most effective technique in~     reducing pain during labor. However, reduction in total dose of local anesthetic and thus~     motor blockade is crucial to improve the obstetric outcome. This technique has evolved from~     intermittent boluses by anesthesiologists to the current standard labor epidural analgesic~     regimens in many institutions in North America and Europe that consist of a local anesthetic~     in combination with an opioid delivered via continuous epidural infusion (CEI) with or~     without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of~     administration has been used: regular bolus of low concentration local anesthetic +~     intermittent bolus (PIEB). This technique would offer safe and superior quality labor~     analgesia and greater maternal satisfaction by reducing total amount of the drug~     combination.~      The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in~     terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The~     secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric~     outcomes, total drug dose and incidence of pain that required top-up administration~     (breakthrough pain)~   "
18912|NCT02809729|"~     Breast cancer is the most frequent malignancy in the female population Brazilian, except~     non-melanoma skin tumors. Surgery plays an important role in regional spot disease control~     and the definition of parameters for the adjuvant treatment indication. Surgical site~     infections (SSI) are defined as wound infections occur following invasive procedures,~     corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most~     common among patients surgical. SSIs should be examined as potential wound contamination~     surgical, understood as the number of micro-organisms in the body and / or tissue being~     operated. Considering this aspect, the cancer surgery breast are classified by their~     potential for contamination by clean. The use of antibiotics to prevent the SSI in~     mastectomies is not standardized in Handbook of National Health Surveillance Agency due to~     the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among~     services. So this randomized clinical trial to evaluate the influence of the use of~     Prophylactic antibiotics in SSI rates in oncological breast surgery.~   "
18913|NCT02809716|"~     This research clinical trial studies high definition single cell analysis in blood and~     tissue samples from patients with colorectal cancer which has spread to the liver. High~     definition single cell analysis allows doctors to study the properties of cancer cells that~     are sometimes found in the blood of patients and to determine how the genes and proteins in~     them may change over time. Studying samples from patients with colorectal cancer in the~     laboratory may help doctors learn more about how cancer spreads, as well as how to predict~     the disease outcomes in patients with cancer.~   "
18914|NCT02809703|"~     The objective of the study is to determine the quality of life of patients in the years~     following treatment with extracorporeal membrane oxygenation (ECMO). The study population~     will include all adults treated with any configuration of ECMO at Duke University Medical~     Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by~     direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed~     them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses~     quality of life. In addition, patients will be asked to opt-in to participate in a phone~     survey in which they can give a narrative about their ICU experience and answer specific~     questions regarding long-term comorbidities. Data will be stored in a secure online server~     which is HIPAA compliant and analyzed by the department of anesthesiology statistical~     support services. De-identified data will be shared with the WHO as specified in their usage~     agreement.~   "
18915|NCT02809690|"~     This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission~     tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate~     cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that~     is given through the vein to take detailed pictures of areas inside the body where the~     tracer is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how~     far the disease has spread.~   "
18916|NCT02809677|"~     The investigators propose a one-year, repeated measures, within-subject design to examine~     the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel~     modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural~     equation model (SEM) in order to explore longitudinal mediation between asthma outcomes~     (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test~     whether caregiver improvement preceded child asthma improvement, and SEM will test whether~     improved adherence and/or decreased child anxiety/depression mediated the effect. The~     investigators considered a randomized control trial, but it would not be ethically~     acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder~     (MDD) for the proposed one-year duration of the study. It is unlikely that potential~     participants in the study would find this acceptable. Furthermore a controlled design is not~     necessary since the investigators are not testing the efficacy of antidepressants for~     depression, but rather the impact of improvement on caregiver depression on the child.~   "
18917|NCT02809664|"~     Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central~     subclavian catheter by supraclavicular route in the newborn.~   "
18918|NCT02809651|"~     The investigators prospectively want to use the Infrascanner in patients with ischemic~     stroke, patients with brain surgery, patients with brain tumors, patients with intracranial~     hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up~     after head trauma or headache to determine to positive and negative predictive value of the~     Infrascanner in these different settings.~   "
18934|NCT02809443|"~     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.~     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in~     man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope~     regions of Zika virus.~      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in~     South America, Central America, and the Caribbean islands commencing in late 2014 or early~     2015. Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome~     in adults and microcephaly and other birth defects among children born to mothers who are~     infected during pregnancy. At present no vaccines or treatments have been approved for Zika~     virus infection.~   "
18919|NCT02809638|"~     In clinical practice, compression ultrasound (CUS) has become an easy and reliable~     noninvasive tool for the diagnosis of deep vein thrombosis (DVT).~      Currently there are not validated methods to assess the biological age of venous thrombus,~     and the date of onset of thrombosis. One potential technique to age DVT is ultrasound~     elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well~     known that thrombi harden as they age. The aim of this study will be to assess the ability~     of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively~     all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower~     limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of~     follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS~     of the lower limbs, and at the same time to the ultrasound elastography by the physician~     expert in vascular ultrasound. The specialist performing both examinations will be unaware~     of the time of onset of DVT (acute or chronic). Then the patients will be divided into two~     groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd~     month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated~     three times in the same patient at the same visit, to assess the reproducibility of the~     technique. The demographic data, medical history, physical examination and the results of~     CUS and ultrasound elastography will be collected in a case report form (CRF) by another~     investigator who does not perform the examinations. The blinded CRF will be submitted to a~     dedicated committee for statistical analysis.~   "
18920|NCT02809625|"~     Brucellosis, also known as Mediterranean fever, undulant fever, or Malta fever is a zoonotic~     disease caused by Brucella infection.With the rapid development of animal husbandry and~     aquaculture and increasing consumption of dairy products in urban residents, the incidence~     of this disease in Inner Mongolia and even in the mainland area of China is significantly~     increased.~      The disease can damage multiple systems including nervous system, circulatory system,~     reproductive system and bone joints, etc. The sooner the diagnosis of brucellar spondylitis~     is diagnosed and treated, the better will be the prognosis of the patients which can prevent~     the development of severe complications and diminish the need for surgical therapy. Thus the~     early diagnosis of brucellar spondylitis was of great significance.We quantitatively~     analyzed the brucellar spondylitis with DCE-MRI to explore the application of DCE-MRI in the~     early diagnosis of brucellar spondylitis.~   "
18921|NCT02809612|"~     Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological~     condition that leads to extreme suffering for both the women involved but also their~     partners. It has also been shown to be associated with poor quality of life, leading to~     depression and anxiety states. When left untreated, the condition takes a very long time to~     resolve, with a substantial associated disability and suffering. Both psycho-education and~     internet-based interventions have been shown to be highly successful while they can be quite~     affordable. This makes them highly cost-effective. The present study aims at evaluating the~     effectiveness of such an intervention among a vulvodynia patient population from the clinics~     of Uppsala, Falun, Örebro and Gävle. The patients will be recruited by treating physicians~     and given access to the internet-based platform, where they will fill out questionnaires~     during four different time-points, after randomization to the control or the intervention~     group. The intervention group will also have access to multiple activities and information~     material uploaded in the internet-based platform. Differences in pain, quality of life and~     mental health parameter outcomes will be assessed at the end of the study. Should this~     intervention prove effective, it will be implemented in clinical praxis in the four regions.~   "
18922|NCT02809599|"~     The study evaluates a theory-based educational intervention and implementation strategy on~     the use of the Dix-Hallpike test (DHT) and Canalith Repositioning Maneuver (CRM) in a~     community Emergency Department (ED) setting. The DHT and CRM are used to diagnose and treat~     Benign Paroxysmal Positional Vertigo (BPPV).~   "
18923|NCT02809586|"~     Social media provides frequent interaction with online social networks, increasing exposure~     to peer influences, which could affect alcohol use in negative or positive ways. The~     proposed study will recruit adolescents and emerging adults using social media ads, and~     conduct online screening, enrolling 850 risky drinkers in a randomized controlled trial~     comparing three conditions: 8-week Social Media Intervention + Incentives, 8-week Social~     Media Intervention Only, and an e-news attention control condition. These innovative design~     features will provide the critical next step in harnessing social media to reduce alcohol~     misuse, which could have enormous public health impact by altering the alcohol use~     trajectories of youth.~   "
18924|NCT02809573|"~     The purpose of this dose-escalation study is to assess the safety and tolerability of~     treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients~     with newly diagnosed peripheral T-cell lymphoma.~   "
18925|NCT02809560|"~     Asthma affects about 10% of children and 6% of adults in industrialized countries.~     Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are~     broadly involved in this pathology in experimental models and in humans. Many studies show~     that the signaling pathways activated by the commitment of T receiver differ depending LT.~     The identification of specific signaling pathways links to Th2 offer new therapeutic~     approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium~     channels sensitive channels Cav1 voltage, normally found in excitable cells where they are~     defined as receivers dihydropyridine (DHP).~      The goal of the present study is to show the presence of Cav1 channels in inflammatory cells~     in allergic asthmatics and show overexpression of these channels in the peripheral blood~     mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in~     comparison with controls.~   "
18982|NCT02808806|"~     The purpose of the ARTEMIS trial is to investigate if real-time feedback to caregivers~     reduces the time between patient's first medical contact and start of intravenous~     thrombolysis and/or intraarterial thrombectomy in patients with acute ischemic stroke.~   "
18983|NCT02808793|"~     This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with~     indolent systemic mastocytosis (ISM).~   "
18984|NCT02808780|"~     The purpose of this study is to compare the incidence of lymphoma in adult participants with~     moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with~     thiopurines.~   "
18985|NCT02808767|"~     This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute~     myocardial infarction.~   "
18926|NCT02809547|"~     It is important that patients who suffer from Rheumatoid Arthritis (RA) have their disease~     monitored at an early stage, as well as when it is established. Presently, if a patient is~     to be assessed by means of disease activity scores and blood tests, they must attend a~     hospital appointment, which can be difficult for patients who live far from the clinic. It~     would be beneficial to be able to monitor and reliably define and report a disease 'flare'~     at home. Quite often, by the time the patient attends for an appointment, flare ups have~     subsided. This study will evaluate the possibility for patients to take their own blood~     samples in the comfort of their own home, by transferring finger prick blood droplets to a~     dried blood spot sample (DBSS) card. Patients would then send the cards to the laboratory to~     test for clinically relevant protein markers. The feasibility of 'remote' monitoring of the~     patient's disease will be explored.~   "
18927|NCT02809534|"~     To assess the primary effects and safety of Anlotinib with placebo in patients with~     Hepatocellular Carcinoma(HCC).~   "
18928|NCT02809521|"~     The purpose of the study is to see if one's liking and awareness of different types of~     activities is related to one's activity pattern.~   "
18929|NCT02809508|"~     The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry~     affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.~   "
18930|NCT02809495|"~     Prostate cancer (PC) is the most common non-skin tumor in men and the second leading cause~     of death from cancer in Brazil. It accounts for 13.8% of deaths from cancer in males,~     similar to what happens with breast cancer in females, corresponding to 15.8% of cancer~     deaths in women. Mobile applications, software developed for smartphones and tablets used~     for many different purposes (games, communication, entertainment etc) have become important~     tools of mHealth (Mobile Health in Portuguese - mobile health) as they allow remote support~     to patients or self-promotion of health care. It has been used globally to assist in the~     treatment and control of various diseases such as diabetes, physical inactivity, and many~     others. In oncology there are several applications developed to assist in the monitoring and~     treatment of various cancers such as gastric and breast cancer. So far it has not developed~     an application for follow-up of patients with PC, to capture data on satisfaction of~     post-treatment patient regarding the comorbidity of surgery, and also loyalty and adherence~     of patients to follow-up in offices allowing a possible intervention it is done at the right~     time. Nor was made compared to assess whether there is benefit in using this application.~     Thus, the objective of this work is to develop an application for smartphones facing the~     postoperative follow-up of patients undergoing robotic radical prostatectomy and compare~     adherence to treatment compared to accompanied by traditional way patient. In addition, we~     will evaluate the progress of the IPSS, ICIQ and IIEF-5 compared to preoperatively in~     patients undergoing prostatectomy robotic radical.~   "
18931|NCT02809482|"~     Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks~     that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues~     is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional~     insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene~     expression in peripheral tissues resulting in a deleterious re-programming of the circadian~     metabolome. Studies in humans have only superficially investigated how the circadian clock~     machinery is impacted by nutritional signals. The overall goal of this pilot project is to~     take the first steps toward developing translational methods to investigate links between~     changes in energy flux and the circadian system in human tissues. Using an innovative ex~     vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF~     compared to eucaloric (EU) feeding on the expression of core clock genes in human~     subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the~     amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following~     short-term HF-OF. This pilot project will serve as a launch point for designing future~     studies into the effects of diet and exercise on the circadian control of metabolism in~     adipose tissue depots as well as other tissues (e.g. muscle).~   "
18932|NCT02809469|"~     Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial~     fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious~     and safe for the overall AF population; however, patients older than age 85, with creatinine~     clearance <40mL/min, or who weighed <50kg were poorly represented in these trials, yet they~     are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and~     low body weight are all associated with elevated drug levels, and elevated drug levels are~     associated with an increased risk of bleeding. Therefore, clinicians are concerned about the~     risk of bleeding and are unsure of how best to treat this patient population. Although other~     anticoagulants are available, apixaban is attractive because it has a low rate of bleeding,~     low dependence on the kidneys for clearance, and does not require frequent ongoing~     monitoring and dose adjustment. This study will include patients taking apixaban who were~     not well-represented in phase III trials - those with age >85, creatinine clearance~     <40mL/min, or weight <50kg - who are also at increased risk of having elevated drug levels~     due to these clinical characteristics. Participants will have apixaban levels measured, and~     those with persistently elevated levels will have their dose reduced. Drug levels will be~     measured again after dose reduction to determine if the levels are reduced without becoming~     dangerously low.~   "
18933|NCT02809456|"~     This project will test the effect of nicorandil to mitigate the lung damage that can occur~     as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung~     cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in~     laboratory animals show that with nicorandil, investigators can significantly reduce the~     severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common~     use for treatment of angina. These studies will advance that work to human use. Successful~     mitigation of lung radiation damage and heart toxicity will improve the quality of life in~     veterans and non-veterans who are treated for lung cancer by radiation, and may also improve~     cure rates of radiation therapy for lung cancer.~   "
18986|NCT02808754|"~     This is a randomized controlled trial designed to test an intervention (Remote ischemic~     preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery~     stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac~     complications, and biomarkers of brain ischemia.~   "
18935|NCT02809430|"~     Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with~     continuous positive airway pressure (CPAP) may prevent this but is limited by poor~     adherence. In this study, the investigators will enroll eligible stroke patients undergoing~     inpatient rehabilitation into an intensive CPAP adherence protocol (iCAP) with an aim to~     increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP will include~     patient education and encouragement, device adjustments, close monitoring of adherence and a~     3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP~     tolerance. If both criteria are met, APAP treatment with iCAP will continue during the~     rehabilitation stay and over a 3-month period. The goal of the intervention is to achieve~     50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month~     treatment period. The investigators will evaluate if demographic, co-morbid or~     stroke-specific factors predict APAP adherence and assess the relationship between APAP~     adherence and neurological recovery. Successful completion of the project will establish the~     feasibility of a definitive trial assessing the ability of APAP to improve stroke recovery~     in the short-term and reduce the risk of recurrent stroke in the long-term.~   "
18936|NCT02809417|"~     This project is associating partners from the public area (university hospital of Nice, Nice~     university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique~     medico-psycho-social shared record.~      The purpose of this project is to significantly improve coordination of care, especially~     between hospital and home. We can expect a significant improvement in the patient's living~     conditions, improving its management, its security and ultimately, lower health care costs.~   "
18937|NCT02809404|"~     Everolimus shows a large interpatient variability with fixed dose administration. These very~     different exposure levels between individuals can result in supratherapeutic or~     subtherapeutic exposure levels and consequently in over- or undertreatment, respectively.~     Dose individualization based on the measured drug concentration could theoretically result~     in less toxicity and more efficacy.~      Nowadays everolimus exposure is determined by everolimus concentration in whole blood.~     Therefore, a vena puncture is always necessary. This is invasive and requires patients to~     come to the hospital. It would be convenient for patients to have their everolimus blood~     concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of~     blood from the finger is necessary, which can be done at home and sent by regular mail for~     analysis. Previous studies have shown the feasibility of this approach. In patients with~     cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS~     concentrations and whole blood concentration is yet unknown. Therefore, the investigators~     want to determine the everolimus concentration collected with DBS from a finger prick with~     everolimus concentration from whole blood and everolimus concentration collected with DBS~     from whole blood.~      In addition, possibly a relatively high everolimus concentration in saliva could be~     correlated with the incidence and severity of oral mucositis. Determination of drug~     concentration in saliva has also been proven to be feasible before.~      Therefore, in this study the investigators want to determine whether the everolimus~     concentration in saliva correlates with the incidence of oral mucositis and how everolimus~     concentration in saliva correlates with everolimus concentration in whole blood.~   "
18938|NCT02809391|"~     The purpose of this study is to increase clinical knowledge of the relationship between~     increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives~     of this study are to determine if orthotics, with and without a textured top cover, can~     alter muscle activation, gait parameters, balance, functional mobility, and decrease fall~     risks in Parkinson's participants.~   "
18939|NCT02809378|"~     The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been~     shown to be relatively high compared other surgeries, with a reported incidence 65-75 %.~     PONV may increase patient discomfort, delay patient discharge, and increase the cost of~     patient care, the risk of postoperative bleeding which may potentially cause airway~     obstruction.~      It is reported that the maintenance of anesthesia with propofol-remifentanil or~     sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane~     alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative~     period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed~     5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV~     particularly during this period.~      The purpose of this study was to evaluate and compare the incidence of PONV after~     thyroidectomy with three different anesthetic methods, sevoflurane or~     sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman~     patients.~   "
18940|NCT02809365|"~     This is a randomized controlled study in type 2 diabetic patients who are presently~     uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients~     need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle~     Libre for 10 weeks.~   "
18941|NCT02809352|"~     Cervical cancer is due to a persistent infection with a group of viruses known as high-risk~     Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a~     procedure called 'HPV testing', which can be used as a relevant screening test. A pilot~     screening program called START-HPV has been set up in the Ardennes, a French administrative~     area localized in the North of France, with HPV testing as a primary screening test.This~     observational study aimed to evaluate hrHPV genotypes repartition in the population who~     participate in the START-HPV screening program. This study will allow a better knowledge of~     hrHPV infection epidemiology in a screened population.~   "
18987|NCT02808741|"~     Single dose comparison of liquid and solid formulation, followed by study of effect of high~     fat breakfast.~      Evaluation of multiple dose pharmacokinetics and tolerability~   "
18988|NCT02808728|"~     Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively~     manage post operative pain control than another local analgesic, Ropivacaine, when both are~     used as part of a multimodal pain management approach?~      The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension,~     will improve total knee arthroplasty postoperative pain with significant improvement of~     early function outcomes.~   "
19088|NCT02807415|"~     The academic investigator - initiated trial will evaluate in a postapproval setting whether,~     and if yes, to what extent and variability, the treatment with lumacaftor in combination~     with ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del~     homozygous subjects with cystic fibrosis under real life conditions.~   "
18942|NCT02809339|"~     Ovarian cancer is a major cause of cancer related death among women. The disease is usually~     advanced at diagnosis, because specialist referral is delayed due to vague nature of~     presenting symptoms. Primary treatment is successful, but most patients experience~     recurrence. Complaints due to disease and therapy overlap. Furthermore treatment schedules~     are similar in response rate and survival rates. Toxicity of therapy as scored by the~     physician is best documented, but varies depending on type of chemotherapy. Moreover most~     knowledge is acquired in clinical trials and not in daily practice. Patient reported outcome~     (PROs) concerning effects on symptoms, velocity of relief and quality of life (QoL) by the~     different regimens is sparce. Also it is unknown which symptoms are best relieved. Most~     trials take into account progression or survival as primary endpoint but not often symptom~     relief, which is especially important for patients with recurrent disease, without no chance~     of cure anymore. Knowledge on rating of problems and needs of patients with recurrent~     ovarian cancer (ROC) to support them in the course of their disease is needed to come to an~     evidence based and patient centered treatment of choice together with the patient.~     Physicians most frequently use the Common Toxicity Criteria (CTC) scale for grading of side~     effects of treatment, but discrepancies with patient experiences is high. Routine collection~     of PROs may therefore improve patient expectations and management. In this project the~     investigators intend to augment knowledge by PROs of different chemotherapy schedules for~     recurrent ovarian cancer in order to improve shared decision making with the physician.~      Objective: primary objective of this project is to explore the relief of symptoms due to~     ROC, the speed with which this occurs by different chemotherapy schedules and development of~     complaints due to the regimen of chemotherapy. Secondary the investigators intend (1) to~     assess preferential symptom relief by patients, (2) to correlate toxicity and symptoms of~     disease to tumor assessed response to chemotherapy and (3) to correlate symptom relief by~     psychosocial context.~   "
18943|NCT02809326|"~     This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT;~     Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), which combines~     individual virtual reality (VR) assisted exposure therapy with group social and emotional~     rehabilitation skills training (will be superior to a treatment consisting of the same VR-~     exposure and group psychoeducational group therapy. TMT will be conducted in traditional~     17-week format, and a 3-week intensive treatment format. Outcome will be assessed using~     relevant clinical, process, and cost outcomes. Additionally, investigators will assess the~     potential of olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and~     re-experiencing. Therefore, this proposal will integrate clinical and neurobiological~     assessment studies designed to understand the role of these factors in the etiology,~     maintenance, and treatment of PTSD.~   "
18944|NCT02809313|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root~     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and~     monitored clinically and microbiologically at baseline and 3-6 months after therapy. All~     patients will receive scaling and periodontal treatment and randomly will be assigned over~     an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet~     will be used once per day during 3 months.~   "
18945|NCT02809300|"~     The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in~     patients with ankylosing spondylitis (AS).~      The secondary objectives are: (1) To determine whether the presence of these antibodies is~     symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence~     of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the~     presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF)~     alpha therapy.~   "
18946|NCT02809287|"~     Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H.~     Reith in 1991, the laparoscope has been widely used in liver disease. Based on its~     advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been~     well recognized globally. Generally speaking, for lesions located in the left, front or~     lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH~     surgery is recommended; however, for lesions located in segments VII and VIII, the surgery~     is high technically difficult due to poor exposure. Therefore,the investigators employ the~     left lateral position plus jackknife position to better expose lesions in these segments,~     hoping to reduce surgical time and bleeding in LH.~   "
18947|NCT02809274|"~     Iron deficiency is a known feature of PV, occurs because of accelerated erythropoiesis,~     gastrointestinal blood loss and phlebotomy. Incidence and effect of iron deficiency in these~     patients is not well characterized. The study will assess the incidence of iron deficiency~     at diagnosis and during the course of PV, assess effect of iron deficiency on patient~     symptoms and its correlation with disease features.~      This is a multicenter, non-interventional, non-randomized, prospective, observational study~     in an adult population (patients >18 years old) of patients who have been diagnosed with PV~     and are being followed in either community or academic medical centers in Israel.~   "
18948|NCT02809261|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. Although many~     conservative managements of CTS, the effectiveness of these methods is insignificant or only~     persist for a short duration. Recently, the ultrasound-guided perineural injection with 5%~     dextrose was widely used for entrapment neuropathy with positive benefit. However, current~     studies have not entirely proved the effects of perineural injection on peripheral~     neuropathy because these studies enrolled small number of patients and lacked controlled~     design. The investigators design a randomized, double-blind, controlled trail to assess the~     effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.~   "
18949|NCT02809248|"~     The aim of the study is to choose an optimal stent and to get further knowledge about the~     mechanisms of the engraftment of a stent.~      The occurrence of a hyperplasia of neointima can be minimized by application of a coated~     stent and a concurrent safety four weekly dual thrombocytes therapy~   "
18989|NCT02808715|"~     Chinese male subjects will be invited to participate in a research study of brown fat, a~     special tissue in the body that is designed to burn energy to make heat. The objective is to~     learn the importance of a gene called PRDM-16 for the function of brown fat. Subjects were~     selected as a possible subject in this study because they fulfil the age and weight~     criteria.~      500 subjects from the Singhealth Investigational Medicine Unit healthy volunteer database~     will be recruited over a period of 2 years. All of the subjects will have their PRDM-16 gene~     sequenced. The objective is to identify subjects with mutations, or changes, in their~     PRDM-16 gene. About 12 subjects with PRDM-16 mutations are expected to be identified.~      Samples of blood obtained during the course of this study will be stored and analysed only~     for the purposes of this study for a period not exceeding 2 years, and will be destroyed~     after completion of the study, unless subject is agreeable to donate the samples to the~     National Heart Centre Singapore for continuous storage for future studies that are approved~     by the institutional review board..~   "
18950|NCT02809235|"~     In this proof of concept study, the investigators aim to determine if supplementation with~     coconut oil causes an increase in cholecystokinin and cholecystokinin receptor expression in~     the airway smooth muscle of lean asthmatics, and whether these changes correlate with~     changes in airway stiffness (estimated by bronchodilator reversibility, airway reactivity,~     and airway resistance) or symptom control.~      The investigators propose a 5 week, single center trial in 20 lean patients with mild asthma~     (not taking inhaled corticosteroids) aged 18 and older. Subjects will supplement their usual~     diets with 3 tablespoons of coconut oil, a commercially available oil with high dodecanoic~     acid content, for 3 weeks. To quantify changes in airway smooth muscle cholecystokinin and~     cholecystokinin-receptor expression, each subject will undergo bronchoscopy with~     endobronchial biopsies before and after coconut oil ingestion.~      For the secondary analysis, subjects will also complete spirometry with bronchodilator~     testing, methacholine challenge, body plethysmography, and an Asthma Control Questionnaire~     (ACQ) before and after the dietary intervention. This information will be used to compare~     the changes in airway smooth muscle cholecystokinin and cholecystokinin receptor expression~     to changes in bronchodilator reversibility, airway reactivity, airway resistance, and~     symptom control.~      In the exploratory aims, the investigators will correlate the changes in airway smooth~     muscle cholecystokinin and cholecystokinin receptor expression with changes in FEV1 and peak~     flow measurements.~      The investigators therefore hope to elucidate information about the mechanistic role of~     cholecystokinin in airway smooth muscle stiffness and contraction.~   "
18951|NCT02809222|"~     Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the~     clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with~     accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML).~     Evolution of MDS is also associated with increase of reactive oxygen species (ROS). The~     increase of ROS is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA)~     is an actor of the regulation of the oxidative metabolism in the human body.~      Studies showed that supplementation with AA can change the proliferation status of MDS~     cells. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of~     MDS and AML. The present study aim at describing the variations of plasmatic ascorbic acid~     concentrations between healthy volunteers and patients with myelodysplastic syndromes~     advanced in their treatment or recently diagnosed during a follow-up of 12 months.~   "
18952|NCT02809196|"~     The overall objective is to examine if participating in an SMS-transmitted health~     educational program targeting a cluster of dietary factors over a period of weeks during the~     years of adolescence can induce durable changes towards more healthful dietary habits. The~     investigators will examine if impact is reinforced by asking a friend of the participant to~     also participate; if impact is reinforced by asking the mother of the participant to also~     participate; and if impact is reinforced when the SMS-transmitted health promotion program~     is designed to target a specific dietary factor only - decided upon from participants'~     reporting of their dietary habits at the beginning of the program - rather than to~     simultaneously target a cluster of dietary issues uniform for all participants.~   "
18953|NCT02809183|"~     This is a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The~     study will enroll approximately 130 adult male and female subjects with Stage 3 or 4 chronic~     kidney disease and low serum bicarbonate levels. The study will be conducted in two parts.~     In Part 1 study drug dosing (TRC101 or placebo) will continue for 14 days twice daily. In~     Part 2 study drug dosing (TRC101 or placebo) will continue for 14 days once daily.~      The maximum study duration is anticipated to be up to 42 days.~   "
18954|NCT02809170|"~     Mitochondrial diseases occur due to inadequate energy production. In addition, nitric oxide~     (NO) deficiency occurs in mitochondrial diseases. The endothelial layer of blood vessels~     functions in maintaining blood vessels patency through producing NO which relaxes vascular~     smooth muscles and therefore maintains the patency of blood vessels and adequate blood~     perfusion. In mitochondrial diseases, endothelial cells fail to perform their normal~     function in maintaining the patency of blood vessels (endothelial dysfunction) because of~     the inability to produce enough NO. Endothelial dysfunction results in decreased blood~     perfusion in different organs which can contribute to the complications seen in~     mitochondrial diseases. The amino acids arginine and citrulline act as NO precursors and can~     increase NO production. In this study we hypothesize that due to the inability to produce~     enough NO patients with mitochondrial diseases have endothelial dysfunction that will~     improve after arginine or citrulline supplementation. The investigators will assess~     endothelial function using peripheral arterial tonometry before and after arginine or~     citrulline supplementation. The investigators expect that arginine and citrulline~     supplementation will improve endothelium function. This will support the therapeutic use of~     arginine and citrulline in mitochondrial diseases.~   "
18955|NCT02809157|"~     Coronary artery disease (CAD) is a very common cause of heart failure affecting millions of~     people worldwide, which is caused by build-up of plaque inside arteries of the heart.~     Build-up of plaque eventually impacts the blood supply to the heart. In medicine, techniques~     (invasive or non-invasive) such as coronary angiography, intravascular ultrasound, computed~     tomography, magnetic resonance imaging, positron emission tomography and transthoracic~     echocardiography can be used to diagnose CAD.~      The investigators aim to study Coronary Artery Disease significance with the combination of~     computed tomography angiography (CTA), and computational fluid dynamics (CFD) methods. CTA~     is a non-invasive technique to visualize arterial vessels, which uses computer-processed~     x-rays. Computational Fluid Dynamics employs digital computers and numerical methods to~     solve complex flow patterns inside arterial vessels. Combining these two methods, the~     investigators are able to provide detailed blood flow information and mechanical stress~     distributions on the vessels. This study therefore, aims to propose a non-invasive~     methodology to assess the significance of CAD.~   "
18956|NCT02809144|"~     Interscalene block has been the traditional regional anesthesia for shoulder surgery and~     postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury~     have encouraged search for alternative methods.~   "
18990|NCT02808702|"~     The purpose of this study is to determine whether neuroimaging-based markers of maladaptive~     self-focused processing are better predictors of treatment response to cognitive-behavioral~     therapy than behavioral markers.~   "
19198|NCT02805959|"~     To study the motility of the bowel in constipated patients. Looking at the difference~     between young and elderly patients with constipation.~   "
18957|NCT02809131|"~     The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown~     rapidly over the past two decades. CIED infections, defined as infections involving the~     generator implant site (pocket) and/or intravascular leads, have become increasingly~     prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds~     of both short term and long term mortality are at least doubled in patients who suffer CIED~     infections, and long term survival is particularly poor in women. Optimal strategies to~     prevent CIED infections in high-risk patients are largely unproven. However, recent~     observational studies of an antibiotic-coated envelope implanted at the time of CIED~     procedure have shown that this strategy is associated with a low incidence of CIED~     infections. Other interventions to prevent CIED infections, including the use of antibiotic~     irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are~     commonly used but not supported by rigorous controlled studies. The Specific Aim of this~     study is to test the hypothesis that the use of the antibacterial envelope alone is~     noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial~     irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device~     infections in patients with ≥2 risk factors for infection.~   "
18958|NCT02809118|"~     The primary objective of the trial is the confirmation of the efficacy of AM-111 in the~     recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).~   "
18959|NCT02809105|"~     The objective of this study is to verify the efficacy and investigate the safety of the~     study drug when ASP0456 is administered orally for 4 weeks and 52 weeks.~   "
18960|NCT02809092|"~     Relapsed acute myeloblastic leukemia (AML) requires remission prior to allogeneic~     Hematopoietic Stem Cell Transplant (HSCT) for optimal survival, but is a disease with poor~     response to chemotherapy. Human leukocyte antigen (HLA) haploidentical, Natural killer (NK)~     enriched peripheral blood cell infusions have shown safety in patients with poor prognosis~     AML. Though not powered for such an assessment, this trial showed a promising but not~     statistically significant trend in remission rate. NK cell therapy was limited by small~     numbers of NK cells attainable through leukapheresis. We have now demonstrated that large~     numbers of NK cells can be propagated ex vivo from a small volume blood draw, obviating the~     need for donor leukapheresis. The purpose of this trial is to determine the feasibility and~     maximum tolerated dose of expanded NK cells and estimate the toxicity of treating~     relapsed/refractory AML with fludarabine + high-dose cytarabine + G-CSF (FLAG) chemotherapy~     followed by haploidentical expanded natural killer (NK) cells.~      The first NK cell dosing cohort will be well below the currently-established safe dose of~     pheresis-derived NK cells, as expanded NK cells may have increased toxicity because of their~     activated phenotype. In order to avoid accruing patients at suboptimal doses, a dose~     escalation schema based on the principles of an accelerated titration design is used in this~     study to allow expeditious advancement up to the current safe dose of NK cells.~   "
18961|NCT02809079|"~     Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the~     central nervous system that leads to blindness and paralysis. Since disability accrues~     incrementally related to attacks, attack prevention with immunosuppressive therapy is the~     mainstay of preventing disability. However, there is no standard immunosuppressive treatment~     strategy for NMO relapse prevention. In a previous study, the investigators provided~     evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective~     strategy which is associated with a reduction in the risk of relapse in Chinese patients~     with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate~     mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other~     advantages. In recent years, MMF has been used in different immune-related neurological~     diseases; some literature shown the possible efficacy of MMF in NMO treatment.~      In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University,~     Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical~     University) study will carry out to evaluate the efficacy and safety of mycophenolate~     mofetil therapy in NMO spectrum disorders.~   "
18962|NCT02809066|"~     This study was planned and conducted to investigate effect of adequate calcium intake on~     Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.~   "
18963|NCT02809053|"~     This is a multi-center, randomized, double-blind, parallel-group study to evaluate the~     statistical equivalence of efficacy, and to assess the safety of SAIT101 versus MabThera® in~     asymptomatic patients with LTBFL. Patients will be randomized in a 1:1 ratio to receive~     study drug once a week for 4 weeks, and will then be followed up for up to 52 weeks after~     the first dose.~   "
18964|NCT02809040|"~     Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to~     high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and~     how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be~     detected on echocardiography (echo), which is a standard clinical method to examine heart~     structure and function using reflected sound waves. Investigators propose to develop a~     digital auscultation system or electronic stethoscope based on wireless sensor node~     technique. Investigators hypothesize that the heart sounds measurements detected by~     electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .~   "
18965|NCT02809027|"~     The purpose of this study is to determine ginger is effective in the prevention of abdominal~     distention in post Cesarean section patient.~   "
18991|NCT02808689|"~     This is a pilot, proof of concept, early stage study. The study goal is to determine whether~     the Functional Medicine approach to the treatment of moderate to severe persistent asthma~     enhances standard guideline-based care with respect to asthma outcomes.~   "
18992|NCT02808676|"~     The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and~     progressive resistance training exercises, combined with cognitive training and Vitamin D3~     supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment~     (MCI).~   "
19005|NCT02808507|"~     The purpose of this study is to compare three strategies for finding TB cases in a rural~     Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2)~     Conducting household contact investigations of newly diagnosed TB cases; 3) Providing~     incentives to newly diagnosed TB cases and their contacts to promote contact screening for~     TB. For each intervention, investigators will measure comparative effectiveness in terms of~     cases identified as well as the cost-effectiveness and feasibility of implementation.~   "
18966|NCT02809014|"~     The literature recognizes that fluoride is the most widely used and studied means for dental~     remineralization. The use of fluoride toothpaste in brushing is considered more rational~     method for the prevention of caries. However, the current challenge of toothpaste is the~     substantivity, so new compounds have been introduced into these formulations. This study~     aims to evaluate the in vivo effect of fluoride dentifrice containing a natural product -~     hydrocolloid tara gum - in fluoride retention in saliva and dental plaque. A study of the~     clinical and laboratory type, crossover, double-blind, randomized will be held. After sample~     calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed,~     missing, and filled teeth index less than 6 and residents in brazilian northeast capital~     will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and~     saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h~     after brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours~     after. It will be 4 toothpastes: 1100ppm F- with hydrocolloid; F- 550ppm with hydrocolloid;~     1100ppm F- without hydrocolloid; Without fluoride with hydrocolloid. Between weeks of use,~     brushing will be extended washout (without fluoride and no hydrocolloid) to avoid carryover~     effect. inferential data analysis will be carried out, considering the amount of alpha~     <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the~     oral fluids promoted by the hydrocolloid may have important impact on Des-Re process and in~     the control of dental caries.~   "
18967|NCT02809001|"~     The purpose of this study is to evaluate whether autologous fat grafting is safe and/or~     effective to prevent expanded skin from expansion failure.~   "
18968|NCT02808988|"~     The investigators evaluated the effect of initial periodontal treatment on clinical findings~     and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in~     gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy~     within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal~     women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic~     periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and~     osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D,~     n=10) at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A,~     B and C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.~   "
18969|NCT02808975|"~     The objective of this study is to assess the safety and efficacy of adalimumab prior to~     surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical~     candidates.~   "
18970|NCT02808962|"~     The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal~     nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to~     innervating the SIJ, distal branches of these nerves also innervate the skin over the~     buttock through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5%~     Bupivacaine) are performed proximal to the origin of both the nerves to the SIJ and the~     cutaneous branches. Therefore, a technically accurate block should anesthetize not only the~     SIJ but also the skin of the buttock regardless of the patient symptoms. Hypoesthesia of the~     buttock would, therefore, be a quality-assurance sign that the block has been performed in a~     technically correct fashion. Similarly, if the target nerves have been accurately ablated by~     RFA hypoesthesia of the buttock should ensue, as an expected effect of the procedure.~   "
18971|NCT02808949|"~     Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.~   "
18972|NCT02808936|"~     The investigators attempt to investigate the organ protective effect of remote ischemic~     conditioning in patients undergoing non-cardiac surgery with history of ischemic heart~     disease.~   "
18973|NCT02808923|"~     The purpose of this study to to compare the long-term effects of foam rolling in comparison~     to static stretching and a control group on hamstring flexibility. The investigators~     hypothesize that participants in the foam rolling and static stretching group will~     demonstrate increased flexibility to the control group, but will a difference will not be~     observed between the foam rolling and static stretching groups.~   "
18974|NCT02808910|"~     This study will investigate whether small changes (nudges) made in a cafeteria, where~     participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks,~     and 6 weeks and 6 months after their stay. Half the participants will be exposed to one of~     four types of nudges (focused on reducing salt intake, increasing vegetable intake, reducing~     portion size, and a combination of these nudges), and half of the participants will eat in~     the cafeteria as it is currently, without modifications.~   "
18975|NCT02808897|"~     The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Clearance~     Technology® (ACT) in reducing the rate of postoperative atrial fibrillation (POAF) among~     post cardiac surgery patients and to evaluate the impact of ACT on other complications, such~     as retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding~     or tamponade, and interventions for hemothorax, pericardial or pleural effusion.~   "
18976|NCT02808884|"~     The investigators have developed an assay that can sensitively and specifically detect DNA~     mutations circulating in human plasma that may be indicators of the presence of a solid~     tumor. This study is a pilot study to measure positive and negative predictive values of~     this assay as an indicator of the presence of a tumor in normal subjects~   "
18977|NCT02808871|"~     The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403~     mg/day for the treatment of RA-associated interstitial lung disease.~   "
18978|NCT02808858|"~     Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS)~     newly diagnosed.~   "
18979|NCT02808845|"~     The purpose of this study is to investigate the association between pre-existing~     microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary~     angiography (CAG).~   "
18980|NCT02808832|"~     The purpose of this study is to develop, deliver and evaluate a provider intervention for~     mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in~     the children and appropriate cervical cancer screening in the mothers.~   "
18981|NCT02808819|"~     The purpose of this study is to continue to characterize the safety profile of benralizumab~     administration and monitor the pharmacodynamic activity of the drug in those asthma patients~     who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor~     study D3250C00021 (BORA).~   "
19006|NCT02808494|"~     Sample Collection Study~   "
18993|NCT02808663|"~     Severe alcoholic hepatitis, defined by a Maddrey discriminant function above 32, is~     associated with significant short-term mortality. In patients with liver disease, studies~     have shown alterations of intestinal bacterial flora and an increase in intestinal~     permeability leading to bacterial translocation across the intestinal barrier. The mechanism~     involved may be an activation of intestinal macrophages with a local release of cytokines~     like interleukin-8 (IL-8).~      Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its~     presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal~     calprotectin may be used as a marker of intestinal inflammation. There is evidence that~     fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of~     the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic~     hepatitis has never been evaluated.~      The main objective of this study was to determine if the initial level of fecal calprotectin~     and its variation after 7 days had a predictive value for the outcome of severe alcoholic~     hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was~     correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and~     predictive of infections.~   "
18994|NCT02808650|"~     This phase I trial studies the side effects and best dose of prexasertib in treating~     pediatric patients with solid tumors that have come back after a period of time during which~     the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1~     inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
18995|NCT02808637|"~     This is a randomized double-blind controlled study and was performed to compare effects of~     rapid injection without aspiration and 10-second manual pressure before injection on pain~     severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.~      The study population included all the infants presenting for DTaP/IPV/Hib to two family~     health centers between April and August in 2015. The study sample included 128 infants based~     on confidence interval of 95% and statistical power of 80%. The sample was divided into four~     groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined~     with rapid injection without aspiration and control groups. There were 32 infants in each~     group. Gender was adjusted in all groups. Stratified and block randomizations were used.~   "
18996|NCT02808624|"~     This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced~     peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin~     and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And~     then neuropathy together with some oxidative stress markers will be assessed at the end of~     treatment duration (three months) .~   "
18997|NCT02808611|"~     An extensive amount of studies indicate that conditioned pain modulation (CPM) test~     paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway~     in healthy controls and pain patients. A number of studies indicate that the autonomic~     nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal~     and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown~     whether these responses predict individual pain susceptibility or CPM efficacy and whether~     different pain modalities evoke different physiological stress responses, i.e. do~     individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to~     controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered~     psychophysical pain levels/CPM efficacy.~      This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to~     investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of~     the ANS will yield decreased CPM efficacy.~   "
18998|NCT02808598|"~     The purpose of this study is to test a program designed to increase African American and~     Hispanic American women's scientific literacy, knowledge of clinical trials, and to~     facilitate breast cancer clinical trial participation.~   "
18999|NCT02808585|"~     This study will be a sequential multiple-dose escalation study that will enroll (randomize~     and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in~     Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive~     a fixed weekly dose of study drug or placebo for a 4 week dosing period.~   "
19000|NCT02808572|"~     To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin,~     fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during~     a 3 year follow-up.~   "
19001|NCT02808559|"~     To quantify the severity of psoriasis in a consistent and clinically meaningful way is~     important in order to decide the therapeutic orientation to take for the patient. PASI~     (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis~     assessment. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system~     performing standardized photos from head to feet and from all angles, which allows to map~     the entire skin covering all the human body in a few minutes.The primary objective of this~     study would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of~     patients with psoriasis human body in a few minutes~   "
19002|NCT02808546|"~     The main purpose of this study is to investigate the region-specific cause of gallbladder~     stone incidence in Jeju Self-Governing Province, Korea.~   "
19003|NCT02808533|"~     Clozapine is the sole AP agent with superiority in treatment refractory schizophrenia, but~     it also is associated with the greatest risk of weight gain and other metabolic~     abnormalities. Topiramate, an anticonvulsant agent, possesses a weight-reducing effect.~     Furthermore, some studies have suggested that Topiramate may be associated with improvements~     in psychopathology in treatment refractory schizophrenia. Here the investigators propose to~     determine the role of topiramate for augmentation purposes (psychopathology) and as an~     adjunctive pharmacological intervention for weight loss in overweight/obese individuals with~     Ultra-Treatment Resistant Schizophrenia or Schizoaffective disorder taking clozapine.~   "
19004|NCT02808520|"~     Purpose of this study is to determine the influence of social factors on participation and~     activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore~     personal and treatment-related factors and their impact on participation will be explored.~   "
19007|NCT02808481|"~     Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients~     sclérodemiques.~      Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.~      we see patient data analysis with systemic sclerosis who used cardiac transplantation to~     understand the primitive cardiac damage associated with systemic sclerosis~   "
19008|NCT02808468|"~     The broad aim of this study is to develop and test a brief intervention that can be~     implemented in the immediate weeks following sexual assault to decrease likelihood of~     developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the~     study will enroll 6 women to complete a brief, cognitive therapy protocol and provide~     feedback on the intervention (open trial). The second phase of the study will recruit 76~     women to complete either the intervention (38 women) or assessment only (38 women) to test~     the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared~     to natural recovery following assault.~   "
19009|NCT02808455|"~     This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the~     relative bioavailability of pacritinib following administration as a 400 mg oral dose of~     four 100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize~     the PK and major human metabolites of pacritinib.~   "
19010|NCT02808442|"~     This study aims at evaluating the safety and ability of UCART19 to induce molecular~     remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute~     lymphoblastic leukemia (B-ALL) ahead of planned allogeneic hematopoietic stem cell~     transplantation (allo-HSCT).~   "
19011|NCT02808429|"~     This study will evaluate the safety and clinical efficacy of atacicept in reducing~     proteinuria (i.e. excess of protein leaking in the urine) in patients with IgA nephropathy~     and persistent proteinuria. The study hypothesis is that treatment with atacicept will~     reduce proteinuria compared to placebo at 1 year.~   "
19012|NCT02808416|"~     Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce~     limited efficacy. Recent advance in cancer immunotherapy has provided important new means to~     treat cancer patients at advanced stages. This study is designed to perform a clinical trial~     to treat advanced caner patients with brain metastases with personalized cellular vaccines.~     The patients will receive vaccines consisting of autologous tumor cells, tumor antigen~     pulsed DCs and peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be~     observed in this study.~   "
19013|NCT02808403|"~     The purpose of this post-marketing survey is to obtain real-world information on the safety~     and effectiveness of evolocumab in Japan.~   "
19014|NCT02808390|"~     This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with~     active, mild-to-moderate UC.~   "
19015|NCT02808377|"~     This is an RCT looking at the primary outcome of composite success following anterior repair~     with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a~     soft silicone pessary inserted into the vagina post operatively for three weeks and the~     other will not.~   "
19016|NCT02808364|"~     The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for~     glioblastoma has shown some efficacy. This study is designed to perform a personalized~     clinical trial by first analyzing the expression of tumor associated antigens in patients~     with recurrent glioblastoma and then immunizing the patients with personalized cellular~     vaccines including autologous tumor cells, antigen pulsed DCs and allogeneic peripheral~     blood mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.~   "
19017|NCT02808351|"~     The number of cardiac angiography and percutaneous coronary interventions (PCI) has~     increased steadily in recent years. This has resulted in the increasing incidence of~     contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes~     mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs,~     hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning~     that in a patient with CKD it amplifies the risk of CIAKI.~      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether~     berberine treatment during and after the perioperative period would reduce the risk of CIN~     in a high-risk population of patients with both DM and CKD undergoing coronary angiography~     or noncoronary angiography, and the influence of such potential benefit on short-term~     outcome.~   "
19018|NCT02808325|"~     It is the objective of the study to investigate the efficacy and safety of two different~     volume replacement regimens with gelatine solutions.~   "
19019|NCT02808312|"~     The primary objective of this study is to evaluate the single-dose pharmacokinetics of~     GS-9674 in adults with impaired hepatic function relative to matched, healthy controls with~     normal hepatic function.~   "
19020|NCT02808299|"~     The purpose of this study is to investigate the incidence of liver injury by statins in~     coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.~   "
19021|NCT02808286|"~     The aim of this project is to evaluate a hybrid emotion-focused treatment protocol,~     specifically developed for individuals who suffer from co-occurring chronic pain and~     clinical levels of anxiety and/or depressive symptoms.~      Specific questions relating to treatment outcome:~        1. Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional~          symptoms (pain-related fear, anxiety, depression)?~        2. Does a hybrid emotion-focused treatment lead to an increase in functional ability,~          improvement in work status and decrease in medication use?~        3. Does a hybrid emotion-focused treatment lead to better treatment effect on the above~          outcome variables compared to an active comparison group?~           Specific questions relating to the process of change:~        4. Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in~          proposed transdiagnostic emotion regulation process variables (worry, rumination,~          cognitive and behavioral avoidance, emotional suppression)?~   "
19022|NCT02808273|"~     A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane)~     as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic~     events in microsurgicals free flaps during head and neck reconstruction.~   "
19033|NCT02808130|"~     The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein~     subfractions have deleterious impact on the development of periodontal infection by altering~     oxidative stres status of periodontal tissues. The aim of this study was therefore to~     investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and~     TAOC levels in patients with different periodontal status,~   "
19089|NCT02807402|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported~     outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic~     hepatitis C (CHC) in a real life setting across clinical practice patient populations in~     Romania~   "
19023|NCT02808260|"~     Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that~     are only detected by implanted pacemakers or defibrillators. Usually people don't know that~     they have these episodes. Over time, these episodes can happen more often and last for~     longer periods. In some people, the heart eventually remains permanently in a fast irregular~     rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If~     physicians could detect atrial fibrillation at a very early stage they could treat people~     early and possibly prevent the condition from becoming permanent. People with implanted~     devices allow a unique opportunity to constantly monitor the heart rhythm so investigators~     can detect any irregularities immediately.~      Investigators don't know which people are at risk of developing short episodes of fast~     irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to~     find out if there are proteins or chemical changes in the blood that can predict the risk of~     developing atrial fibrillation. These chemical changes, also known as biomarkers, may also~     be able to give investigators other clues about atrial fibrillation.~   "
19024|NCT02808247|"~     This is a prospective, multicentric, randomized, open label Phase II trial investigating~     whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic~     compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS~     after failure of first line chemotherapy prolongs progression-free survival.~      The primary objective of the trial is to evaluate whether nintedanib given as second-line~     therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival~     when compared with ifosfamide.~      Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in~     terms of progression-free survival rate at 12 weeks, overall survival, objective response~     rate, patient benefit rate, response duration, total duration of treatment with nintedanib~     safety, Health related Quality of Life and Health Economics.~      Exploratory objectives include an analysis of putative predictive biomarkers for the~     anti-tumor effects of the investigational agent nintedanib.treatment.~   "
19025|NCT02808234|"~     The study is a prospective non-randomized multi-center feasibility clinical trial to~     establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody~     fusion procedures.~   "
19026|NCT02808221|"~     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which~     can be prevented by early action. The management of HF is complex: long, often difficult and~     costly. In France, nearly one million people suffer from HF and 120,000 new cases are~     diagnosed every year. With the aging population, this number will continue to evolve and~     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart~     failure in either the 3 most common diseases in industrialized countries.~      Investigators goals are to make an inventory of PRADO-IC project in terms of its~     effectiveness on readmission of patients with heart failure.~   "
19027|NCT02808208|"~     The aim of this phase 1 study is to determine the role of autologous adipose derived~     mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when~     applied during the time of surgical creation.~   "
19028|NCT02808195|"~     The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb~     motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.~     The specific aims of this study project will be:~      To compare the effectiveness of intervention groups using Kinect-based ULMTS with~     constraint-induced therapy on motor improvement in children with hemiplegic CP. The~     investigators hypothesize that motor improvement in using Kinect-based ULMTS will be~     comparable to constraint-induced therapy.~   "
19029|NCT02808182|"~     Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin~     resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to~     associated complications such as heart failure, kidney failure and microvascular diseases.~     Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to~     prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable~     isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT~     storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed~     that this impairment is associated with greater cardiac DFA uptake, as well as subclinical~     left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest~     weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA~     storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It~     has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin~     sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage~     directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently~     uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least~     in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes.~     Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be~     linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron~     triglycerides (TG) uptake in men. Here, the investigator will isolate and compare~     organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA~     pools, as well as the oxidative vs. non-oxidative intracellular metabolic pathways~     associated with increased cardiac DFA uptake in pre-diabetic men and women.~   "
19030|NCT02808169|"~     Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb~     length evaluation during Anterior hip replacement as measured intraoperative with C-Arm~     visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.~   "
19031|NCT02808156|"~     This 3-year research project aims to investigate and compare the immediate and long-term~     treatment effectiveness as well as motor improving curve and potential predictors of the~     unimanual intensive training and bimanual intensive training protocols with an equivalent~     intervention period in children with hemiplegic CP and children with CP with apparently one~     side affected. In addition, based on the ICF-CY model, comprehensive outcome measures~     including motor functions as well as psychological functions will be included.~   "
19032|NCT02808143|"~     The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the~     tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent~     in patients with bladder tumors. Another purpose of the study is to see what tumor~     characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab~     (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune~     cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab~     is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a~     type of skin cancer) and some types of lung cancer. It is not yet approved by the United~     States Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an~     investigational agent for this disease.~   "
27803|NCT02693223|"~     Get With The Guidelines-Stroke is a program for improving the quality of care for patients~     hospitalized with stroke by promoting consistent adherence to the latest evidence-based~     clinical practice guidelines.~   "
19034|NCT02808117|"~     This study will analyze data from a program run by an microfinance institution (MFI) in~     Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it~     operates. By comparing health indicators among children who were in villages targeted by the~     program initially to children who were in villages that were not targeted by the program~     until later, the investigators hope to understand if the MFI successfully delivered the~     intervention and offer a practical platform for delivery of basic health goods.~   "
19035|NCT02808104|"~     The purpose of this study is to determine whether a controlled release formulation of~     mazindol is more effective than a placebo in the treatment of Attention Hyperactivity~     Disorder (ADHD) in adults.~   "
19036|NCT02808091|"~     -  Assess responses, progression free survival (PFS) and overall survival (OS) of the~          combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT)~          in Stage IB or bulky disease - II and without IMRT in Stage III - IV.~        -  Assess the toxicity and maximum tolerated dose of bortezomib administered in~          combination with GIFOX chemotherapy.~   "
19037|NCT02808078|"~     The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority~     randomized control trial in neurorehabilitation. The main objective is to test whether a 4~     weeks gait rehabilitation program that uses augmented reality is superior to a conventional~     treadmill training program of equivalent intensity. Baseline assessments precede allocation,~     which consists in blocking randomization (2:1 ratio) with stratification according to the~     disease etiology. Post-intervention assessments serve to compare the short-term efficacy of~     the intervention between the two groups. Three months after discharge, follow-up assessments~     take place to detect potential long-term effects.~   "
19038|NCT02808065|"~     Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was~     developed through clinical trial with healthy volunteer. The purpose of this study is to~     confirm predictability of developed pharmacokinetic model in kidney transplant recipients.~   "
19039|NCT02808052|"~     This is a Phase 1, open-label, single-dose study of the safety, tolerability, and~     pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal~     insufficiency.~   "
19040|NCT02808039|"~     to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a~     hyperreactive phase of platelet function~   "
19041|NCT02808026|"~     To examine antihypertensive effect and safety of administration of CS-3150 in patients with~     severe hypertension (Grade III).~   "
19042|NCT02808013|"~     Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the~     efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with~     moderate to severe lower urinary tract symptoms (LUTS)~   "
19043|NCT02808000|"~     This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating~     safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of~     both latex and silicone. The included patients are permanently catheterized spinal cord~     injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.~      Primary Outcome Measures:~      • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley~     catheters, compared to the use of standard catheters for the same time period, on re-current~     symptomatic catheter associated urinary tract infection (CAUTIs).~      Secondary Outcome Measures:~      • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria,~     bacteremia, urosepsis and ICU stay.~      Exploratory Outcome Measures:~      • assessment of levels of immunological markers in urine, urinary bacterial type and~     resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the~     catheter surface after use.~   "
19044|NCT02807987|"~     To examine antihypertensive effect and safety of administration of CS-3150 in combination~     with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.~   "
19045|NCT02807974|"~     To examine antihypertensive effect and safety of administration of CS-3150 in combination~     with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.~   "
19046|NCT02807961|"~     This is the first study in humans of ELX-02, an advanced synthetic aminoglycoside optimized~     as a translational read-through drug (TRID) for the treatment of genetic conditions caused~     by nonsense. mutations. This is a classical Phase 1a study designed as a randomized,~     double-blinded, placebo-controlled, single dose escalation to evaluate the safety,~     tolerability and pharmacokinetics of ELX-02 in healthy adult volunteers.~   "
19047|NCT02807948|"~     This study is a prospective, non-randomized, multi-center study of subjects implanted with~     an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac~     resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI~     scan.~   "
19048|NCT02807935|"~     The purpose of our current series of studies is to evaluate different glaucoma treatments in~     vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal~     (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The~     images will be taken as part of the patients routine medical follow up (before starting the~     treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will~     be measured using commercially available 3-dimensional reconstruction.~      The series of studies will be divided into 3 branches, each branch contains different~     treatments.For each treatment different patients will be recruited.~      The branches are as following-~        1. The surgical branch-~             1. Before and after trabeculotomy~             2. Before and after cataract surgery~             3. Before and after vitrectomy surgery~             4. Before and after XEN™ Gel Stent implant~        2. The pharmacological branch-~             1. Before and during the treatment with prostaglandins analogs~             2. Before and during the treatment with alpha blockers~             3. Before and during the treatment with beta blockers~             4. Before and during the treatment with carbonic anhydrase inhibitor~        3. The laser branch-~             1. Before and after trabeculoplasty~             2. Before and after laser iridotomy~             3. Before and after yag capsulotomy laser~   "
19072|NCT02807623|"~     The purpose of this clinical investigation is to evaluate the efficacy and immunologic~     effects of a non-pharmacological exercise intervention (pushups) compared to an oral NSAID~     (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of~     delayed pain, erythema, and edema and any impact on serologic antibody immune response after~     influenza vaccine receipt.~   "
19049|NCT02807922|"~     Sleep disturbance is frequent in patients with advanced cancer and decreases the~     tolerability of other symptoms and impairs quality of life. A detailed description of sleep~     disturbance and its association with other symptoms, and intervention studies on sleep~     medications are scarce in patients with advanced cancer. A well-designed randomized~     controlled trial is needed to determine the short time effectiveness of zopiclone on sleep~     quality, one of the currently available therapies of insomnia, and further to contribute to~     the clinical management of insomnia in patients with advanced cancer.~   "
19050|NCT02807909|"~     The study is being conducted to assess the effects of co-administration of itraconazole or~     diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T)~     of BMS-986177~   "
19051|NCT02807896|"~     Multiple biomarker development through validation of useful markers generated by next~     generation bio-data based genome research and cohort study~   "
19052|NCT02807883|"~     You are being asked to take part in this study because you either had Ph positive B-lineage~     acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently~     received an allogeneic stem cell transplant (cells from someone else).~      The goal of this clinical research study is to learn if blinatumomab in patients who have~     had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming~     back in patients who either have a small amount of ALL or have had ALL in the past. The~     safety of this drug will also be studied.~   "
19053|NCT02807870|"~     Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent~     mental disorders in children and is associated with important negative functional outcomes~     throughout development. The first signs and symptoms become apparent in preschool age.~     Therefore, early interventions in this population have the potential of limiting the~     disorder's negative impact and preventing future impairments in affected individuals. The~     first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy~     and safety in preschool children. However, non-evidence based worries and pressure from the~     media placed parent training as the first-line treatment for ADHD in clinical guidelines.~     Parent training is a behavioral intervention implemented with the parents, with weekly~     sessions for 8 to 12 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors.~     However, the level of evidence for this intervention is reduced. Furthermore, the need of~     trained therapists in the public health system, added to the difficulties on adherence and~     comprehension from parents, limit its generalization and raise questions regarding its~     indications. Until now, no study has compared pharmacological treatment with methylphenidate~     to parent training in preschool children with ADHD regarding their clinical efficacy and~     cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological~     intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for~     determining their impact on neurodevelopment.~      Objectives: This is a double-blind randomized clinical trial that aims to evaluate the~     efficacy, tolerability and acceptability of treatment with methylphenidate compared to~     parental training and placebo in preschool children with ADHD. Furthermore, the~     investigators propose the use of advanced neuroimaging techniques for the assessment of~     changes in brain connectivity from the institution of treatment.~      Methods: This study will be a randomized, double-blind, parallel-group, evaluating two~     active interventions and placebo control group. One hundred and fifty children aged 3 years~     and 11 months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive~     treatment with methylphenidate and information (50 children), parental training and~     treatment with placebo medication (50 children) or belong to active control group with~     educational information for parents and placebo treatment with no treatment (active control,~     50 children). The treatment will last eight weeks, the neurobiological outcomes will be~     assessed before and after treatment and clinical outcomes will be assessed at weeks 0, 4 and~     8 will also be evaluated 50 children with typical development in relation to neurobiological~     measures.~      Implications: This study proposes an innovative and relevant analysis, which will enable the~     field to advance the knowledge of biological mechanisms related to ADHD and to treatment~     response. Also, the study will expand the evidence to guide early prevention strategies and~     early intervention.~   "
19054|NCT02807857|"~     This low interventional study, whose unique intervention will be to measure the blood level~     of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by~     Primary Care Physicians (PCPs) in Europe, will assess if the cardiologist referral guided by~     NT-proBNP measurement in patients who are currently judged by PCPs as being stable, will~     lead to optimization of HF treatment, defined in adherence to treatment recommendations of~     the current European Society of Cardiology guidelines for the treatment of heart failure.~   "
19055|NCT02807844|"~     The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of~     MCS110 with PDR001 in adult patients with solid tumors.~   "
19056|NCT02807831|"~     Background: environmental influences in the first years of life have a great impact on~     adulthood. Adequate environmental stimulation in the first years of life positively~     influence cognitive, emotional and neurological development. Studies show that high quality~     education for 3 to 6 years old children are cost-effective for diverse outcomes, such as~     socioemotional and cognitive development, as well as school performance. However, it is not~     clear why specific types of interventions are most effective on school readiness, an~     important precursor of literacy status and later life outcomes. Objectives: adapt to the~     Brazilian context two well-known intervention programs: (1) executive functions training~     developed by Diamond, and (2) oral language skills based on the Nuffield Programme developed~     by Snowling and colleagues. Methods: a randomized controlled trial involving 720 children (4~     to 5 years old) allocated to three groups: (1) adapted school curriculum focusing on~     executive functions training, (2) adapted school curriculum focusing on oral language skills~     training, and (3) regular school curriculum.~   "
19057|NCT02807818|"~     Home visiting programs for pregnant women aiming to improve mother-infant relationship has~     received worldwide attention in the past 30 years. These programs are considered an~     important strategy to improve women's health during pregnancy, aside from improving child's~     birthing conditions and allowing parents access to tools which will nurture and properly~     stimulate their baby, thus promoting emotional and cognitive development. Objectives: The~     Nurse home visitation program for pregnant youth aims to promote infant´s healthy~     development, from pregnancy to the first months of life, in a high-risk population. Methods:~     Eighty young pregnant women aged between 14 and 20 years were randomly allocated to the~     intervention or to usual prenatal care program. The Nurse home visitation program for~     pregnant youth was developed based on Albert Bandura's theory of self-efficacy, on Urie~     Bronfenbrenner´s bioecological model, which recognizes the importance of individual and~     family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth~     evolutionary theories of attachment, which involves the care practitioner addressing issues~     such as environmental health, life course and parenting, bond between mother and infant, and~     infant´s social and cognitive development. Neuropsychomotor development will be assessed at~     3, 6 and 12 months using the Bayley Scale of Infant Development. Brain development will be~     assessed via electroencephalography at 6 and 12 months.~   "
19085|NCT02807454|"~     This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab +~     daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will~     also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to~     durvalumab + daratumumab (PD3).~   "
19058|NCT02807805|"~     This phase II trial studies the side effects and how well abiraterone acetate, niclosamide,~     and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens~     can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight~     prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug~     that may block another signal that can cause prostate cancer cell growth. Prednisone is a~     drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and~     prednisone may be a better treatment for patients with hormone-resistant prostate cancer.~   "
19059|NCT02807792|"~     This protocol will test a new prototype of a peri-anal access device, with increased~     flexible length and a captured operative field, for feasibility in patients immediately~     prior to their scheduled peri-anal procedure.~   "
19060|NCT02807779|"~     This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular~     healing. The study will evaluate subjects with peripheral artery disease (PAD) who require~     an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to~     the leg.~   "
19061|NCT02807766|"~     Autism is a well-recognized neurodevelopmental disorder severely affecting the health of~     children. While the unclear neurobiological basis of autism and the lack of effective~     medication, the most commonly used approach for treatment is behavioral intervention.~     However, the pathophysiological mechanisms underlying the intervention therapy remains~     incompletely understood. The current project aims to explore the impacts of different early~     behavioral intervention methods on brain plasticity of autism using multimodal MRI technique~     and provide guidelines for the intervention and treatment of autism by evaluating the~     efficiency of these methods.~   "
19062|NCT02807753|"~     To evaluate the prevalence of subclinical arthropathy in children with severe hemophilia~     undergoing a prophylaxis regimen and without evidence of target joints, using a validated~     ultrasound scoring method.~   "
19063|NCT02807740|"~     Patients affected by Parkinson disease (PD) can benefit from rehabilitation although the~     evidences are scattered. In the last years there are increased evidences that virtual~     reality can improve functional outcome in Parkinson's disease. No evidences are known~     concerning the cardiological safety and effect on balance of Virtual Reality. The aim of~     this study is to compare a virtual reality rehabilitation program versus a conventional one~     in a sample of patients affected by mild to moderate Parkinson and to collect data on~     cardiological effects.~   "
19064|NCT02807727|"~     This study will evaluate the benefit of Intralipid® or placebo administered prior to~     reperfusion to limit ischemia reperfusion injury as measured by the geometric mean~     difference of the release of troponin I over 72 hours after coronary artery bypass.~   "
19065|NCT02807714|"~     The purpose of this study is to find an association between a protein named Podocan and WNT~     pathway regulatory molecules in patients with different forms of Coronary Artery Disease~     (Acute Coronary syndrome, Stable Angina and Coronary Artery Restenosis). It has been found~     in experimental studies that this protein is regulating smooth muscle cell function and~     hence may be influencing the progression of Coronary Artery Disease (CAD). We are testing to~     see if the same regulatory function exists in human subjects. Studying patient's blood will~     possibly enable to identify an association between Podocan and CAD. This may help to better~     prevent and treat CAD with improved understanding of the mechanism of the disease. No drugs~     or other therapeutic interventions will be used for the purpose of the research study. Only~     blood samples will be collected in the cardiac catheterization lab. As a part of this study~     participants will be followed for repeat events or repeat cardiac catheterization over a~     period of 24 months.~   "
19066|NCT02807701|"~     Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of~     periampullary and pancreatic diseases including malignant and benign conditions. The outcome~     of PD has improved over the last two decades due to advances in surgical techniques,~     anesthesia and perioperative care. Although studies from high volume centers demonstrate~     reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still~     ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive~     alternative to traditional interventions for pancreatic resection. Laparoscopic~     pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular.~     Nevertheless, comparative data on outcomes remain limited. In this prospective randomized~     study, investigators evaluate the safety and feasibility of surgical and oncological~     outcomes of minimally invasive PD compared to conventional open PD.~   "
19067|NCT02807688|"~     The study evaluates the efficacy of health promotion strategies on diet and physical~     activity in patients with psychosis. Half of the participants will receive an intervention~     protocol based on education and behavioural change, while half will not receive it.~   "
19068|NCT02807675|"~     This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to~     evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily~     dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's~     disease (PD).~   "
19069|NCT02807662|"~     The objectives of this research study are to screen 750 pregnant women at risk of~     trauma-related stress symptoms, and adapt and test an evidence-based intervention for~     pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer~     community health centers.~   "
19070|NCT02807649|"~     To evaluate the efficacy of Nutrilite® ginkgo biloba cistanche tablets in relieving the~     symptoms of chronic fatigue syndrome(CFS), the investigators randomly recruit189 subjects~     with CFS, aged 35-60 yrs. The relief of fatigue and improvement of sexual function are~     evaluated by World Health Organization Quality Of Life Brief (WHOQoL-Bref), Sexual Life~     Quality Questionnaire (SLQQ), chronic fatigue syndrome, symptoms of self-assessment at the~     baseline and the end of intervention. Subjects also underwent a blood test measuring the~     concentration of biochemical indicators. Cistanche is mainly used to strengthen the renal~     function, nourish essence and blood in the treatment of lumbar debility, impotence,~     infertility and muscles weakness, constipation. etc. The study is to test the hypothesis~     that consecutive 60-day intake of the study tablets can relieve the symptoms of CFS;~     according to the change of blood biology indicators, the investigators will also evaluate~     the association between the change of plasma outcome measures and chronic fatigue syndrome.~   "
19071|NCT02807636|"~     A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy~     versus chemotherapy alone in participants with untreated advanced urothelial cancer.~   "
19073|NCT02807610|"~     The ideal induction agent for day care surgery should have properties of rapid, smooth~     induction, better haemodynamic profile, faster recovery and devoid of side effects in the~     form of pain on injection, involuntary movements, respiratory depression and post-operative~     nausea/vomiting. Propofol is the drug being used for day care surgeries because of its~     rapid, smooth induction and faster recovery. But its use is associated with pain on~     injection (even with added lidocaine), hypotension and respiratory depression. So the need~     for an agent with better hemodynamic control and lesser side effects was felt. The~     introduction of etomidate lipuro revolutionised the anaesthesia practice. It possesses many~     of the properties of an ideal induction agent. This newer formulation of etomidate in lipid~     emulsion i.e. etomidate lipuro is known to have rapid, smooth induction, haemodynamic~     stability and lesser side effects than older etomidate with propylene glycol (hypnomidate).~      Hence, investigators devised a prospective randomized controlled open trial and compared~     this newer lipid formulation of etomidate with propofol in terms of - induction time,~     haemodynamic parameters and side effect profile.~   "
19074|NCT02807597|"~     The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided~     tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study,~     the investigators will conduct intraoperative imaging procedures that have minimal~     interference with ongoing surgery. The underlying hypothesis is that the accurate detection~     of all cancer cells highlighted by LS301 during surgery will reduce the number of breast~     cancer patients with margin positivity to less than 5%, compared to the current surgical~     paradigm of greater than 20%. The pilot study will obtain critical data required to address~     the larger question of surgical margin assessment in a full Phase I clinical trial.~   "
19075|NCT02807584|"~     This study will look at whether ELECT, a new adhesive foam dressing, can offer an~     alternative to traditional wound care methods.~      Patients will be treated with ELECT for 14 days. Data relating to wound healing, the~     performance of the dressing and the opinion of the doctor will be collected.~      The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose'~     and will be effective at treating a variety of wounds.~   "
19076|NCT02807571|"~     This study is aimed at determining if office based surgery is an effective way of cutting~     health care cost while maintaining patient safety and satisfaction.~   "
19077|NCT02807558|"~     The purpose of this study is to determine the activity of SY-1425 in patients with~     relapsed/refractory acute myeloid leukemia (AML), relapsed/refractory high-risk~     myelodysplastic syndrome (MDS), newly diagnosed older AML patients who are unsuitable or~     unable to tolerate conventional therapy, or lower-risk myelodysplastic syndrome (MDS)~     patients who are positive for a RARA super-enhancer associated biomarker.~   "
19078|NCT02807545|"~     This study will be a multi-center, dual-arm randomized control study evaluating skeletally~     immature patients with mild AIS curves. At six institutions, patients will be randomized~     into either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE~     group will receive training in SSE, posture, and activities of daily living by physical~     therapists certified in Schroth-based exercise methods. The control group will not receive~     SSE instruction and will only be observed by their treating orthopaedic surgeon (which is~     considered the standard-of-care treatment method). Results will be compared after one year~     of treatment.~   "
19079|NCT02807532|"~     To investigate whether apelin can be used as an indicator to predict postoperative atrial~     fibrillation in patients with coronary atherosclerotic heart disease, and to provide an~     objective basis for the clinical selection of a preventive intervention program for atrial~     fibrillation.~   "
19080|NCT02807519|"~     Oral complications during and after cancer treatment are common. A key role in maintaining~     oral health plays saliva. In the last decade numerous studies have investigated~     immunological biomarkers such as cytokines in saliva samples. In children, the few studies~     have investigated salivary cytokines (sCK) suggesting that these are associated with oral~     health (sCK). One study investigating sCK in adult oncology patients showed an association~     between Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD)~     in survivors of hematopoietic stem cell transplantation. Therefore determination of sCK~     concentrations may also be helpful for assessment of GVHD activity and other inflammatory~     processes in cancer patients. In pediatric oncology patients, to the investigators'~     knowledge, no study has so far investigated sCK concentrations as markers for oral or~     systemic health.~   "
19081|NCT02807506|"~     This project develops and tests the use of service robots to track health of the elderly~     over time. The objectives are to develop a low-cost mobile manipulator capable of a limited~     set of elder- relevant manipulation tasks (e.g. picking up dropped items). The investigators~     will visualize and model the use of the service robot during deployments at an elder care~     facility. Feedback from focus groups with elders and clinicians will inform the necessary~     engineering innovation.~   "
19082|NCT02807493|"~     The primary objectives of this study are to determine if the use of an Occlusal Support~     Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor,~     reduce the incidence of labor complications including Caesarian Sections and improve Apgar~     scores in newborns~   "
19083|NCT02807480|"~     This project aims to identify brain and behavioral characteristics of individuals~     experiencing symptoms of generalized anxiety disorder that will predict the effectiveness of~     Exposure-based therapy versus Behavioral Activation Therapy. Brain imaging aspects of the~     study will use functional magnetic resonance imaging (fMRI) and electroencephalography~     (EEG). Behavioral assessments will include self-report questionnaires, computer-based and~     observational tasks, and interviews. Assessments will focus on how individuals process~     positive information (such as reward) and negative information (such as distressing images),~     as well as how people make decisions. These assessments will be conducted across 2-3~     in-person sessions prior to beginning the treatment, and will be repeated across 2-3~     in-person sessions after completing treatment. A blood draw will also be conducted pre- and~     post- treatment. Both the Exposure-based and Behavior Activation therapy will consist of 10,~     90-minute weekly therapy sessions conducted in small groups.~   "
19084|NCT02807467|"~     In this randomized study, the investigators aim to test the hypothesis that the~     reinstitution of a normal circadian rhythm by continuous infusions of dexmedetomidine~     compared to propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium,~     decreases the duration of delirium. The infusions might have to be repeated several times to~     achieve resolution of delirium.~   "
19090|NCT02807389|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell~     transfer using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of~     20 million cells. 15 adult patients (age 18 and greater) with persistent symptomatic~     post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic~     therapies will be enrolled. The subjects will be subsequently followed for fistula response~     and closure for 18 months. This is an autologous product derived from the patient and used~     only for the same patient.~   "
19091|NCT02807376|"~     This prospective, randomized, controlled, multi-center study will collect and compare data~     from the surgeon's current standard of care stapler (for renal artery and renal vein~     transection) and powered vascular stapler~   "
19092|NCT02807363|"~     This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide~     evaluation of the PK/PD metrics of two different oral doses selected upon the results of the~     study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens. The~     PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for~     the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg).~     Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the~     estradiol suppression and cessation of the menstrual period) will also be evaluated against~     the Lupron Depot historical data.~   "
19093|NCT02807350|"~     The main objectives of this randomized trial comparing overminus lens treatment to~     non-overminus (spectacles without overminus or spectacles with plano lenses) are to~     determine:~        -  The long-term on-treatment effect of overminus treatment on distance IXT control score.~        -  The off-treatment effect of overminus treatment on distance IXT control score~          (following weaning and 3 months off treatment).~   "
19094|NCT02807337|"~     Prospective double-blinded randomized clinical study. Aim of the study is to compare the~     effectiveness of Caphosol mouth rinses in prevention of oral mucositis as compared to 0.9%~     NaCl rinses. Patients will be randomized to receive either Caphosol or 0.9% NaCl rinses four~     times a day for seven days from the beginning of chemotherapeutic regimen. The same patient~     will be given the opposite rinse during the next chemotherapeutic regimen, so everyone will~     get both mouth rinses once during the trial.~   "
19095|NCT02807324|"~     Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are~     associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover,~     it is known that often the pregnancy induced CV adaptation does not resolve completely after~     a short postpartum (PP) period and it is not clear whether these induced changes will~     resolve over a longer period of time (i.e. in the upcoming months/years after delivery).~     Understanding the cardiac adaptation during pregnancy and the reversal process in the~     postpartum period, as well as the factors that influence this these processes, may provide~     us not only insight in this mechanism, but may help us in identifying factors that may be~     target points for modification.~   "
19096|NCT02807311|"~     Undernutrition is the result of energy and protein deficiency and / or catabolic. These~     phenomena are observed daily in patients awaiting lung transplantation.~      After lung transplantation that undernutrition is growing (on average 11% weight loss after~     the first observations in the continuing care of the University Hospital of Strasbourg). In~     other words the non-malnourished patients become. Hence the importance to reach every~     patient awaiting transplant, mainly to patients already malnourished before surgery.~      Several studies have shown that early nutritional support has a direct effect on reducing~     comorbidities and the average length of stay. In the course of care of these patients it is~     necessary to intensify the dietary management to give them the best chance for early~     rehabilitation.~   "
19097|NCT02807298|"~     This study compared the anesthetic efficacy between Lignocaine and articaine administering~     it intraligamentarly using ligajet in twenty five female patients having irreversible~     pulpitis on bilateral mandibular molars. At 5minutes of post injection, the teeth were~     isolated with rubber dam and access performed. Patients were instructed to definitively rate~     any pain felt during endodontic procedure. If patient felt pain, the treatment was~     immediately stopped and the patient rated their discomfort using Heft Parker VAS. The extent~     of access achieved when the patient felt pain was recorded as within dentin, entering the~     pulp chamber or initial file placement. The success was defined as the ability to access and~     instrument the tooth without pain (VAS score of zero) or mild pain (VAS rating<54mm).~   "
19098|NCT02807285|"~     The primary objective of this expanded access program is to provide ocrelizumab as treatment~     for eligible participants with primary progressive multiple sclerosis (PPMS) before it is~     commercially available in the United States (U.S.) for the indication of PPMS.~   "
19099|NCT02807272|"~     A Phase 2 study to investigate the antitumor activity in terms of overall response rate~     (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive~     tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7~     and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may~     continue to receive tipifarnib treatment until disease progression. If a complete response~     is observed, therapy with tipifarnib will be maintained for at least 6 months beyond the~     start of response.~   "
19110|NCT02807129|"~     The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The~     elderly population is very heterogeneous, it is necessary to evaluate these elderly patients~     before treatment to assess the risk-benefit balance. To date, this assessment relies on~     subjective clinical methods often not optimal, and slow to implement. An innovative method~     of evaluation could be the determination of elastin peptides. Indeed, the rate of these~     peptides, which are linked to serious conditions associated with age, rising inexorably with~     age and dose could help determine more objectively the type of treatment to offer older~     patients.~      Expected results : This study will allow better identification of the group of frail elderly~     through more relevant biological marker that clinical assessment, often subjective and not~     available within a period compatible with the treatment of newly diagnosed cancer. This~     biological assessment will also enable optimal management of elderly patients in particular~     by allowing the geriatrician better efficiency.~   "
19111|NCT02807116|"~     The primary objective is to evaluate the effect of rifampin, a potent cytochrome P450 3A4~     inducer, at steady-state on the systemic exposure of a single dose of pacritinib in healthy~     subjects.~   "
19100|NCT02807259|"~     Female sex workers (FSWs) frequently experience violence from their intimate partners~     (non-paying lovers), which compromises their health and increases their the risk of~     infection with HIV or other sexually transmitted infections. Samdevena Plus is a complex~     multi-level intervention that works with FSWs, their intimate partners, the sex worker~     community and the general population. The intervention aims to reduce partner violence and~     increase consistent condom use within these relationships.~      The intervention consists of: (i) couples counselling sessions between FSWs and their~     intimate partners; (ii) separate group work among FSWs and intimate partners to increase~     self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis~     management systems that address domestic and sex worker violence; (iv) training male~     'champions' to encourage action against violence; and (v) training media to promote informed~     discussions about violence and HIV risk.The program involves changing perceptions on~     acceptability of physical violence as a form of discipline, challenging assumptions that~     give men authority over women, and working with men and women to encourage new relationship~     models based on equality and respect. The intervention will reach 800 FSWs and their~     intimate partners living in 47 villages in north Karnataka, India. The evaluation uses a~     cluster-randomized control trial design that introduces the intervention into half of~     villages for the first 24 months and the remaining half receive the intervention thereafter.~     The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent~     condom use in their intimate relationship; and ii) experiencing partner violence within the~     past 6 months.~   "
19101|NCT02807246|"~     This study was designed as a prospective controlled study to investigate the effects of~     probiotic support started immediately after birth on newborn jaundice in breastfed babies~     born by normal spontaneous vaginal delivery.~   "
19102|NCT02807233|"~     The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide~     Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with~     acromegaly in daily clinical practice.~   "
19103|NCT02807220|"~     The objective of this study is to evaluate the efficacy and safety of Imuneks 10 mg Capsules~     in the prophylaxis of cold and the maintenance of the good health state in 70 healthy~     subjects.~   "
19104|NCT02807207|"~     The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of~     pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF)~     interval in healthy subjects.~   "
19105|NCT02807194|"~     Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia~     in surgery for lumbar disc herniation.~   "
19106|NCT02807181|"~     The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT)~     using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment~     (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic~     cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus~     SIRT, and half of the patients will be randomized to CIS-GEM alone.~   "
19107|NCT02807168|"~     Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it~     is the most frequent cause of hospitalization of patients over 65 years old. Of these~     patients, more than 50% will be readmitted within the next six months with the consequent~     worsening prognosis, increased mortality and high costs associated. In fact, two-third parts~     of the costs of this condition are due to hospitalizations. Hence the increased importance~     of ADHF and its associated hospitalizations as an essential event in the natural history of~     the disease on to address therapeutic efforts.~      However, at the present time there is a change of scenario that makes that more than half of~     these patients show HF with preserved ejection fraction (PEF), so that acute heart failure~     with preserved ejection fraction (AHF-PEF) is a fact with high prevalence and~     epidemiological relevance. To this the investigators must add that, unlike patients with~     depressed EF, HF-PEF has no therapeutic strategies that may have proven a recovery of the~     affected patients. All this makes that overall heart failure with PEF and AHF-PEF represent~     a major health problem.~      However, despite of the lack of effective treatments, there are also opportunities for~     improvement both in terms of morbidity and mortality that should be evaluated. Rather than~     looking for therapies or new specific drugs, these opportunities may be in the use of~     management strategies among which the use of biomarkers and their monitoring could be key.~     In this regard, NT-proBNP has been shown to correlate with severity and prognosis, including~     the risk of decompensation. Nevertheless, whilst the latest guidelines for heart failure~     management recommend its use in the diagnosis of HF, the use of biomarkers to monitor and~     guide treatment has not been included yet.~      The assumption of this study is that the use of NT-proBNP may serve as a therapeutic and~     management guideline for the in-patient with HF-PEF who is to be discharged, allowing a~     reduction of decompensations and hospitalizations as well as a better functional situation~     at 6 months.~      Several criteria have been proposed to define the syndrome of HFpEF according to the 2013~     ACCF/AHA Heart Failure Guideline including (a) clinical signs or symptoms of HF; (b)~     evidence of preserved or normal LVEF; and (c) evidence of abnormal LV diastolic dysfunction~     that can be determined by Doppler echocardiography or cardiac catheterization The assay~     N‑terminal proB‑type natriuretic peptid is indicated as an aid in the diagnosis of~     individuals suspected of having congestive heart failure and detection of mild forms of~     cardiac dysfunction. The test also aids in the assessment of heart failure severity in~     patients diagnosed with congestive heart failure. This assay is further indicated for the~     risk stratification of patients with acute coronary syndrome and congestive heart failure,~     and it can also be used for monitoring the treatment in patients with left ventricular~     dysfunction.~   "
19108|NCT02807155|"~     In Los Angeles County, the most populous county in the United States, there are an estimated~     8,000 children under the age of 21 with type 1 diabetes. Although provisions for pediatric~     care exist, once these children become young adults they age out of their health care~     services. There is no formal transitional care program to help these individuals through~     this process of changing health plans and many end up without adequate care. This project~     aims to develop and implement a transition care program for young adults with type 1~     diabetes in order to ensure uninterrupted transition from pediatric to adult diabetes health~     care and improve health and psychological outcomes.~   "
19109|NCT02807142|"~     The objective of the study is to determine if the cell therapy NC1 administered in the~     spinal cord is effective for the treatment of a post-traumatic syringomyelia. The~     post-traumatic syringomyelia is the development and progression of cyst filled with~     cerebrospinal fluid (CSF) within the spinal cord. The cell therapy NC1 consist on cells~     obtained from the bone marrow of the patient, that are cultured in vitro and administered in~     the spinal cord of the same patient.~   "
19112|NCT02807103|"~     Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority~     research, comparing rituximab-based regimen with conventional therapeutic strategy for the~     induction of remission in patients with eosinophilic granulomatosis with polyangiitis~     (EGPA).~      Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to~     receive:~        -  Experimental therapeutic strategy based on the use of rituximab (experimental group)~        -  Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease~          severity (comparative group)~   "
19280|NCT02804867|"~     This study aims to identify signs of depression and bipolar disorder by measuring changes of~     certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use~     these biomarkers to develop a diagnostic test to enable early treatment, which can lead to~     better patient outcomes.~   "
19113|NCT02807090|"~     Supervised exercises are the first line therapy for patients with chronic low back pain. The~     lumbar segmental stabilization (LSE) is a specific training for the muscles of the lumbar~     spine, which aims to improve neuromuscular control, strength and endurance of the muscles~     that promotes stability to the spine. The circular dance (CD) belongs to the group of~     complementary and integrative practices entered in Public Health Care in Brazil, and has~     been used to improve several aspects related to physical and mental states such as~     flexibility, posture, strength and muscular endurance, awareness or scheme body, pain~     control and strains. There are few studies evaluating the circular dance effect on back~     pain. The aim of this study is to compare the effects of lumbar stabilization exercises and~     circular dance for improvement in non specific low back pain in middle-aged women.~   "
19114|NCT02807077|"~     This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg~     dose of pacritinib will be administered orally to patients with renal impairment (mild,~     moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and~     weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of~     pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary~     objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal~     impairment.~   "
19115|NCT02807064|"~     This study is aimed at assessing the efficacy of supplementation with a mixture of three~     bifidobacteria , on the allergic rhinitis..The rhinitis symptoms were assessed by validated~     score ( TSS ) , for children aged between 4 and 17 years with allergic rhinitis parietaria ,~     mild , moderate or severe , than children not supplemented .~      Secondary Objectives~        -  The effectiveness of treatment by VAS :~        -  Evaluation of the rescue medication consumption~        -  Evaluation of quality of life ( using structured questionnaire )~        -  Evaluation of the frequency and school performance ( using structured questionnaire )~        -  Assessment of sleep quality and attention (through structured questionnaire )~        -  Satisfaction rating and satisfaction of parents~        -  Evaluation of asthma exacerbations in children susceptible~   "
19116|NCT02807051|"~     This will be an open-label, single-center, crossover, one-way, drug-interaction study to~     evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a~     single 400-mg dose of pacritinib in healthy male and female subjects.~   "
19117|NCT02807038|"~     A single group of pregnant women who was analyzed in the first and in the third trimesters~     of pregnancy~   "
19118|NCT02807025|"~     Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary~     fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy~     controls for comparative data.~      Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory~     response in different respiratory diseases. To assess molecular biomarkers and signatures to~     see if these can aid diagnosis, stratification of these respiratory diseases. To direct~     personalised medicine and rationalise therapy.~      Outcome measures:Measurement of levels of inflammation, coagulation, complement activation~     and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess~     the tolerability of absorption procedures in these patients.~   "
19119|NCT02807012|"~     Associated with the worsening of functional capacity of older adult and the lack of guidance~     on how to care of them after stroke, the family caregiver starts to fell burden related to~     the care, and the quality of life was affected by that burden. Besides that, the older adult~     began to use more frequently health services and had more hospitalizations by preventable~     conditionals with adequate care.~      The aim of this study is to evaluate the effectiveness of educational interventions of care~     at home provide by nurses to family caregivers of older adult with stroke after hospital~     discharge, compared with usual care guidelines or no guidance, in one month follow up. The~     family caregivers of older adults post stroke with the first functional sequel from the~     Clinical Hospital of Porto Alegre (HCPA) will participate in the study.~      The intervention will involve the systematic monitoring of nurses through home visits (HVs)~     during one month. Thus, will instrumentalize the family caregiver to care of older adult~     with stoke according the protocol developed in a research group and the needs of care of~     them. The control group won't receive the home visits and could have or not the usual care~     guidelines provide by health services that have access.~   "
19120|NCT02806999|"~     Berberine is a conventional component in Chinese medicine. In recent years, effects of~     Berberine on improvement of glucose metabolism have been explored. The purpose of this study~     is to observe the therapeutic effects of combination of insulin and berberine on stress~     hyperglycemia in patients after cardiac surgery.~   "
19121|NCT02806986|"~     Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects~     and 20 pediatric subjects treated with subcutaneously administered IGSC 20% who complete the~     entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC~     20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC~     20% weekly doses). A total of 52 doses of IGSC 20% will be administered with a final~     follow-up visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained~     on self-administration of IGSC 20% by the clinical site personnel.~   "
19122|NCT02806973|"~     This study will investigate how the body processes LY900018 and the effect of LY900018 on~     the body. The study drug will be delivered into the participant's nostril(s) (intranasally)~     once or twice in each of four study periods. The study is expected to last about 50 days for~     each participant. The study is open to adults with type 1 or type 2 diabetes and will last~     about 50 days.~   "
19123|NCT02806960|"~     This study will investigate how the body processes LY900018 and the effect of LY900018 on~     the body. The study drug will be delivered into the participant's nostril(s) (intranasally)~     once or twice in each of four study periods. The study is open to adults with type 1 or type~     2 diabetes and is expected to last about 50 days for each participant.~   "
19124|NCT02806947|"~     The study is a Phase II randomized, open label, multicenter trial designed to identify~     whether sirolimus is a potential alternative to prednisone as an up-front treatment for~     patients with standard-risk acute GVHD defined according to clinical and biomarker-based~     risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus)~     as well as a novel BMT CTN developed acute GVHD biomarker test.~   "
19125|NCT02806934|"~     Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro~     fertilization (IVF) in women without female infertility factor ?~   "
19129|NCT02806882|"~     Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in~     methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus~     Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on~     pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.~      Ceftaroline was approved by the European Medicines Agency for the treatment of complicated~     skin and soft tissue infections and community-acquired pneumonia.~      Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.~      Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with~     gram-negative Bacilli.~      The rationale of this study is based on the antibacterial spectra of ceftaroline that could~     be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated~     infections.~      To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in~     meningeal compartment after treatment.~   "
19130|NCT02806869|"~     This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data~     from healthy subjects under fasting and fed conditions which are necessary for mechanistic~     absorption model development. Up to 30 subjects will be enrolled into this study. Each~     subject will be asked to complete two GI tube insertion procedures. Subjects will complete~     this study twice under the same conditions of the GI tract, either fasting state or fed~     state, in order to provide intra-subject variability. A minimum of 7 days will separate each~     GI tube insertion procedure. The objectives of this study are, as follows: Objective #1: To~     acquire human GI physiology data including GI motility, pH of GI fluids, and GI fluid volume~     under fasting and fed conditions; Objective #2: To measure drug concentration and calculate~     drug dissolution in the GI tract in vivo under fasting and fed conditions; Objective #3: To~     monitor plasma drug concentration and evaluate pharmacokinetics of administered drug during~     GI tube insertion studies under fasting and fed conditions. These in vivo results will be~     used to validate in vitro dissolution methods and to support computational and mathematical~     modeling efforts, in order to develop an oral drug product optimization process that may be~     applied to future drugs to maximize oral drug safety and efficacy.~   "
19131|NCT02806856|"~     Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can~     lethally damage neurons and glia. Excitotoxicity triggers a number of events that can~     further contribute to tissue death. Such events include peri-infarct depolarizations (PID)~     and cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic~     penumbra. Noninvasive brain stimulation techniques such as transcranial direct current~     stimulation (tDCS) are emerging as promising tools, owing to their effects on modulating~     cortical activity. Experimental studies have indicated that cathodic polarization of the~     cortical surface blocks initiation of CSD. Moreover, it has been recently demonstrated in~     murine stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the~     acute phase of stroke, decreasing the number of spreading depolarizations and reducing the~     infarct volume by 20 to 30%.~      The investigators propose here a pilot study, in acute middle cerebral artery stroke~     patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of~     this study will be two years. Fifty acute middle cerebral artery stroke patients will be~     included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of~     evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between~     imaging on admission and 24 hours later. The investigators propose the hypothesis that in~     acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing~     therapies.~   "
19132|NCT02806843|"~     Our study goal is to assess natural patient-therapist interactions in order to map such~     human-human activities to robot-human interactions. Critical to accomplishing this mapping~     will be determining the feasibility of a humanoid robot interacting with a patient in a more~     intuitive and flexible way, while concomitantly investigating the issue of safe contact and~     release.~   "
19133|NCT02806830|"~     In this study, ocular discomfort following intravitreal injection in naïve patients will be~     studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular~     discomfort.~   "
19134|NCT02806817|"~     Prospective, randomized, open label, two arms,, phase 0 clinical trial. HER2-negative breast~     cancer patients recently diagnosed will be screened for trial participation.~      A biopsy will be scheduled the week prior to or the same day as the FDG PET.~     Paraffin-embedded tumor samples will be used to evaluate the stainings of Ki67, cleaved~     caspase-3 and microvessels, and frozen tumor samples will be used to evaluate SDH staining.~      The FDG-PET will be followed by the bevacizumab dose (15 mg/kg IV, single dose). After one~     week, the PET will be repeated in order to detect the patients that have experienced FDG~     uptake decay.~      Right after, treatment with ME-344 (arm 1) or no treatment (arm 2) will start. ME-344 will~     be administered at 10 mg/kg on day 8, 15 and 22. Surgery will be performed on day 28 (thus,~     4 weeks after the bevacizumab dose, which is considered a safe window for antiangiogenics).~      Fragments of the surgical specimen will be collected. Paraffin-embedded tumor sample will be~     used to repeat (and compare) the stainings of Ki67, cleaved caspase-3 and microvessels, and~     frozen tumor sample will be used to repeat (and compare) SDH staining.~      Patients will come off trial in case of consent withdrawal, unequivocal disease progression~     is observed, unacceptable toxicity occurs, or in case of intercurrent disease or any other~     condition deemed incompatible with continuation in the clinical trial by the investigator.~   "
19135|NCT02806804|"~     This study evaluates the safety and immunogenicity of the quadrivalent influenza virus~     vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3~     groups,receiving the test vaccine, commercially available trivalent influenza vaccine and~     trivalent influenza vaccine containing new influenza B component respectively. Each group~     has 800 subjects,2400 in total.~   "
19160|NCT02806453|"~     A randomized controlled cross-over trial in full-term infants affected by symptoms~     suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal~     Reflux Questionnaire Revised).~      The parents of all of the enrolled infants will be reassured on the benign nature of the~     condition and will advise to apply lifestyle changes for one week.~      Than, the patients will be randomized into one of the two sequence treatment groups. (group~     A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks.~     Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.~   "
19136|NCT02806791|"~     The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and~     differentiation of hematopoietic progenitors commissioned to mature as neutrophils and~     activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is~     used to reduce the duration and complications of chemotherapy-induced neutropenia and to~     stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells~     in order to use them for autologous transplantation procedure.~      Filgrastim and Lenograstim originator are marketed for many years and are considered the~     reference molecules for the production of biosimilar.~      For several years it is available and entered into common clinical practice the use of~     filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.~      Aim of the study is to analyze retrospectively a large series of patients and assess the~     impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood~     counts post autologous transplantation; the data will be compared with a historical cohort~     of reference that has been treated with G-CSF originator.~      The study results will not generate any diagnostic or therapeutic intervention in patients~     still alive.~   "
19137|NCT02806778|"~     The use of protective ventilation (to maintain normoxia and normocapnia), optimise~     haemodynamics, diagnose/treat seizures, therapeutic hypotermia etc is recommended for ICU~     management of patients who have had cardiac arrest and remain in coma after return of~     spontaneous circulation according to the latest International Guidelines. These actions~     essentially aim to limit secondary brain injury but despite all therapeutic effort, the~     cerebral oxygenation may remain inadequate and there is no validated method to avoid such a~     state in real time.~   "
19138|NCT02806765|"~     The purpose of this study is to determine whether specific nutrient supplementation can~     improve dynamic stability in older adults.~   "
19139|NCT02806752|"~     The purpose of this study is to evaluate the effects and safety of ranibizumab therapy~     combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal~     vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes~     polymorphism in response to the treatments. To further confirm the role of inflammatory~     factors in the pathogenesis and advance of PCV.~   "
19140|NCT02806739|"~     The purpose of this study is to assess the feasibility of randomizing pregnant women at high~     risk for gestational diabetes to a 24-week period of soy food consumption. This study will~     also examine the effects of soy protein and isoflavones on glucose metabolism and lipid~     levels among pregnant women at high risk for gestational diabetes, and on child's weight and~     height at birth and 6 weeks of life.~   "
19141|NCT02806713|"~     Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a~     retropubic midurethral sling operation.~   "
19142|NCT02806700|"~     Twitter use is surprisingly well represented across broad demographic population segments~     and health-related messages. The promise of using Twitter is that its use is growing~     rapidly, it allows the investigators to view communications that were impossible to~     intercept before, and it potentially provides information faster and less expensively than~     collection from other media channels. Prior work also supports that social media~     interventions can improve health behavior change (e.g. weight loss, physical activity) and~     outcomes.The overarching goals of this proposal are to understand the uses and limitations~     of this communication channel to improve patients' ability to manage their CV health~     condition.~   "
19143|NCT02806687|"~     Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death~     in Western countries, and its incidence has increased over the last 40 years. Curative~     surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority~     (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they~     lack specific symptoms and early markers for this disease. For these patients, palliative~     armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more~     recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis~     for PDAC is still very poor and there is great need for new treatments that can change this~     poor outcome. In this context, the investigators have devised, in the past few years, a~     highly innovative approach based on therapeutic gene transfer, which does not rely on a~     specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators~     found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects~     to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On~     the basis of these promising preclinical data, the investigators conducted past three years~     the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by~     endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally~     advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02~     is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is~     distributed within the bloodstream in some extent, when combined with Gemcitabine it can~     inhibit primary-tumor progression and dissemination. Our results tend to demonstrate~     therapeutic efficacy, especially in patients with locally advanced tumors. Based on these~     encouraging results, the investigators propose that patients with locally advanced PDAC at~     the time of diagnosis may clinically benefit from this approach.~      This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of~     CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced~     PDAC.~   "
19144|NCT02806674|"~     Approximately 50% of people in the world are infected with H. pylori, and its eradication~     rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for~     infection include lower socioeconomic status, younger age, and geographic location.In the~     present study, investigators aimed to perform a prevalence survey about risk factors for H.~     pylori infection.To obtain the higher eradication of H. pylori and find out the relevance~     between the diverse infection and clinical drug focused on refractory H. pylori infection.~   "
19145|NCT02806661|"~     Through comparative observation of robot vagus nerve preserving distal gastric cancer~     radical surgery and conventional robot distal gastric cancer radical surgery (not reserved~     vagus nerve) operative and postoperative indicators, and evaluating the feasibility and~     safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric~     cancer. Which can provide the evidences for the clinical development of the preserving~     function gastric cancer surgery.~   "
19146|NCT02806648|"~     A phase II trial to assess the activity and safety of PD0332991 in patients with well- and~     moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with~     overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)~   "
19147|NCT02806635|"~     This study investigates the effectiveness of www.OurRelationship.com, which provides~     self-help, web-based programs to improve romantic relationships and related outcomes.~     Couples will be randomly assigned to complete the OurRelationship program, the PREP Online~     program, or a wait-list control group and followed for six months.~   "
19148|NCT02806622|"~     The purpose of this study is to compare hip passive range of motion (ROM) among division II~     collegiate athletes in order to obtain normative data for future research. The investigators~     hypothesize that there will be a difference in passive hip ROM among the different genders~     and sports.~   "
19149|NCT02806609|"~     Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness,~     muscle recruitment, dynamic postural control and quality of sleep in young soccer players.~      Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same~     football club and with the same routine practices and games. At first athletes will respond~     to the IC and will be submitted to the test of a repetition maximum. After three days the~     athletes will analysis of muscle recruitment by electromyography and dynamic posture control~     through the force platform both during the time of shooting, moreover, will respond to scale~     the quality of sleep the previous night and one on pain, then they are instructed to perform~     a fatigue protocol for the quadriceps and then will be randomized to one of four~     intervention groups: cold water immersion, submersion in water at room temperature, or~     active recovery control. The same APPRAISAL be remade into three new moments, 24, 48 and 72~     hours after the fatigue test.~      Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle,~     quality of sleep the night after intervention protocol, electromyographic analysis of the~     rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as~     well as postural control when the shot off.~      It is intended to establish the best way of recovery of late quadriceps muscle pain and~     contribute to the clinical practice of active recovery or rest in young soccer players.~   "
19150|NCT02806596|"~     This prospective study aimed to determine the minimal level of Bispectral index needed for~     quality laryngoscopy before ear, nose and throat surgery in children.~   "
19151|NCT02806583|"~     Caring for people with dementia (PwD) at home requires an enormous amount of time,~     organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD~     often feel a high burden. Even though support groups on-site have shown positive effects on~     the subjective well-being and on the perceived social support of ICs, relatives either have~     no time or opportunity to leave the PwD alone or there are no support groups in the~     vicinity. The Talking Time project therefore aims to close this supply gap by providing~     structured telephone-based support groups in Germany for the first time. International~     studies have shown resulting benefits for ICs.~      Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled~     trial. The effects of the 3-months Talking Time intervention will be compared to a normal~     care group. Outcomes will be measured at two different times (baseline = T0, after 3 months~     =T1). The control group will receive the Talking Time intervention after T1.~      ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on~     four days per week in the last six months. Exclusion criteria are psychiatric disorders of~     the IC.~      Primary outcome of the effectiveness elevation is the subjective well-being of the relatives~     measured by the mental component of the SF-12. Secondary outcomes are the physical component~     summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction~     Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative~     and qualitative data sources will be collected addressing reach, fidelity, and dosage.~   "
19152|NCT02806557|"~     The purpose of this trial is to observe the changes in white cell counts in patients with~     cancer during chemotherapy and to determine if changes in the white cell count in the early~     days during chemotherapy can be used as a predictor of severe neutropenia and its~     complications.~   "
19153|NCT02806544|"~     This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with~     locally advanced hormone receptor positive breast cancer in a low/middle income country.~   "
19154|NCT02806531|"~     This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged~     6-35 months old by the method of both passive and active surveillance.~   "
19155|NCT02806518|"~     Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing~     radiation or contrast injection. The study evaluates if DIRT can be an alternative to~     computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared~     with hand-held Doppler, CTA and intraoperative findings.~   "
19156|NCT02806505|"~     This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in~     participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were~     undergoing hemodialysis.~   "
19157|NCT02806492|"~     The purpose of this study is to determine whether cerebral blood flow and cerebral tissue~     oxygenation is most dependent on cardiac output or on mean arterial pressure in patients~     undergoing cardiac surgery with the use of cardiopulmonary bypass.~   "
19158|NCT02806479|"~     This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in~     comparison to patients with well-understood arrhythmogenic substrate (ischemic~     cardiomyopathy), as well as to individuals free from arrhythmogenic substrate~   "
19159|NCT02806466|"~     -  Background: Asthma is a frequent disease characterized by bronchial~          hyperresponsiveness, inflammation and remodeling. Consistent epidemiological data~          indicate that outcome of asthma in adults may be determined in early childhood. This~          may be due to bronchial remodeling, an abnormal repair process that contributes to the~          development of poorly reversible airway narrowing. It appears very early in the natural~          history of the disease and involves increased mass of bronchial smooth muscle (BSM).~          The mechanism of such an increase has been related with an increase in smooth muscle~          cell proliferation. Recently, we have demonstrated that in severe asthma, BSM increased~          proliferation is induced by an enhanced mitochondrial biogenesis. Moreover, we have~          also shown that immature human, non-asthmatic airway smooth muscle cells (ASMC)~          proliferate to a greater extent than normal adult ASMC, in a similar fashion to adult~          asthmatic ASMC. Immature ASMC may thus have great potential to stimulate airway~          remodeling. We thus hypothesized that remodeling is an early process and certain~          characteristics of ASMC in severe preschool asthma may predispose such children to~          persistent remodeling with airway obstruction later in life.~        -  Purpose: To investigate prognostic factors of airway remodeling in preschool children,~          with special attention to ASMC proliferation (mitochondrial mass & biogenesis).~        -  Methods: In the initial phase of the project, 75 severe asthmatic preschool children~          (<5 yr) will be prospectively recruited from the CHU de Bordeaux and the CHU de~          Toulouse according to the Haute Autorité de Santé criteria. Inclusion visit will~          include written informed consent, asthma control evaluation, clinical examination, lung~          function testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood~          sample for total IgE levels. Bronchial specimens from all subjects will be obtained by~          fiberoptic bronchoscopy at visit 2. Airway remodeling will be evaluated by~          morphological analysis. After smooth muscle mitochondria will be analyzed by electronic~          microscopy & immunoblotting. Comparison between the 2 groups will be performed by~          unpaired t tests for parametric data and x2-tests for non-parametric data. In the~          second phase of the project, patients will then be followed-up till the age of 7-10~          yrs, when another bronchoscopy with biopsies will be performed.~   "
19161|NCT02806440|"~     This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain~     in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled,~     cross-over study.~      It is a 2-center study that takes place at The Multidisciplinary Pain Center in Copenhagen~     and at The Multidisciplinary Pain Center in Give.~   "
19163|NCT02806414|"~     This study will assess the role of topical Ivermectin 1% cream and its effect on protease~     and antimicrobial peptide expression in rosacea. This is a single-site 16-week open label~     study at University of California, San Diego. The investigators will do this by first~     measuring serine protease activity and cathelicidin of all subjects. All subjects will~     receive Ivermectin topical cream and will be instructed on how to apply it daily for 12~     weeks. Participants will return for monthly visits during which their clinical symptoms of~     facial redness and number of facial papules will be scored, and they will have repeat tape~     stripping. At the end of the study, tape strips will be analyzed to determine serine~     protease activity of participants at each of their visits and expression of cathelicidin~     (LL-37) mRNA. The investigators will then look at changes in serine protease activity and~     LL-37 expression over time, and they will also determine whether or not these changes~     correlate with disease severity.~   "
19164|NCT02806401|"~     The purpose of this prospective randomized study was to compare landmark-subclavian venous~     access to ultrasound-guided axillary venous access when performed by pediatric~     anesthesiologists.~   "
19165|NCT02806388|"~     This study aims to screen tumor molecular profile for better selection of anticancer~     treatment, in particular, allocation to clinical trials if available.~   "
19166|NCT02806375|"~     A number of groups have demonstrated very low incidence of acute and chronic~     graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in~     haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse~     of the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently~     one of the most promising drugs in the treatment of steroid-refractory GVHD. On the other~     hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib~     before allogeneic SCT might improve the outcome. This pilot trial evaluates whether the~     combination of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the~     risk of graft failure and disease progression in myelofibrosis patients.~   "
19167|NCT02806362|"~     The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks~     of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and~     pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV~     GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have~     ESRD on HD.~   "
19168|NCT02806349|"~     The purpose of this study was to determine whether the co-administration of a~     konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled,~     cross-over trial can improve diabetes management.~   "
19169|NCT02806336|"~     Obesity is a major risk factor for mobility problems in older adults and many older adults~     use a walking aid to help with their mobility. The use of a walking aid changes normal~     walking patterns and makes walking harder, leading people to have more functional problems.~     The purpose of this study is to test the effects of 12 months of a multi-modal balance~     intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional~     performance, balance, and economy of gait. Participants will be one of 120 participants in~     the VAMHCS. Participation in this study is voluntary. The research will be conducted at the~     VAMHCS. The entire study will take approximately 4 years to complete. Subjects'~     participation in the study will last 24 months.~   "
19170|NCT02806323|"~     The goal of this pilot study is to determine the feasibility of an individually tailored~     yoga program delivered in a group setting for the treatment of chronic neck and back pain in~     a low income population. Chronic pain is one of the most common, costly, and disabling~     conditions, and is often refractory to treatment. Yoga is a promising treatment for chronic~     pain. This pilot study will test the hypothesis that study subjects will participate in a~     voluntary 12 week yoga intervention for the treatment of chronic neck and back pain, as~     assessed by attendance at 12 weekly yoga practice sessions. Secondary outcomes will include~     change in pain and quality of life scores over the 12 week study period as assessed by the~     Visual Analog Scale for Pain Severity and EQ-5D-3L.~   "
19171|NCT02806310|"~     Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with~     valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to~     play role in abnormal aortic distensibility and stiffness with impairment of aortic~     elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not~     understood completely. In a recent study podocan is found in extracellular matrix (ECM) of~     human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no~     current effective therapy that can alter the progression of aortic dilatation in bicuspid~     valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated~     aorta and aortic dissection. In this study the aim is to investigate the association between~     podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide~     more effective and physiological understanding of disease process and potential target in~     prevention and treatment for aortopathy.~   "
19172|NCT02806297|"~     Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus~     after resolution of pain for mild gallstone pancreatitis.~   "
19173|NCT02806284|"~     The purpose of this study is to determine wether skull trauma or neurosurgery affect the~     immune response to two vaccine types.~   "
19174|NCT02806271|"~     Worry postponement is a commonly recommended treatment component in cognitive behavioral~     therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally~     occurring instances of worry to a designated 30 minute worry period later in the day.~     Despite being commonly recommended, there is little known about the efficacy and mechanisms~     of worry postponement. The purpose of this study is to determine the efficacy and mechanisms~     of change of a two-week worry postponement intervention in people with Generalized Anxiety~     Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two~     weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only~     control condition. Changes in worry or associated features will be examined at post~     intervention and at a 2-week follow up.~   "
19175|NCT02806258|"~     In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and~     CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis~     is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and~     survival without additional toxicity, as seen with WBI~   "
19176|NCT02806245|"~     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low~     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased~     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD~     undergoing surgery with CPB can experience well-characterized post-operative cardiac~     dysfunction. When severe, patients can develop clinically important low cardiac output~     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise~     is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine,~     which affect the strength of the heart's muscular contractions. These are used to maintain~     adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental~     to myocardial function and may increase risk for post-operative arrhythmia and impair~     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).~     In combination with the increased VO2 associated with CPB-induced systemic inflammatory~     response patients can develop a critical mismatch between oxygen supply and demand,~     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic~     stability without increased VO2 are beneficial. This study will test whether BiVp, a~     specialized yet simple pacing technique, can improve post-operative CI and recovery in~     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study~     hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 72 hours~     in infants with EMD following CHD surgery compared to standard care alone.~   "
19177|NCT02806232|"~     The Phase II study consisting of two parts, part 1 is open label, randomized, controlled and~     exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni.~     Part 2a investigates efficacy and safety in children 3 months to 2 years in an~     age-de-escalating design and part 2b is optional and investigates the efficacy of L-PZQ in~     S. hematobium.~   "
19178|NCT02806219|"~     This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects~     designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP)~     200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of~     a injection device (e-Device, test).~   "
19179|NCT02806206|"~     Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the~     small bowel. The small bowel is about 4 meters long. The battery time of the capsule is~     about 8 hours. During this time the capsule takes pictures as it passes through the small~     bowel. In about 15-20% of capsule tests the battery expires before the capsule passes~     through the entire small bowel into the colon. Incomplete tests indicate that a variable~     portion of small bowel was not visualized. Incomplete tests are associated with potential~     missing of abnormalities in the portion of small bowel that was not reached. The capsule~     test may often required to be repeated but the problem of incomplete examination may~     persist. At present no medication has been approved to increase the rate of complete capsule~     tests.~      Prucalopride is a medication that has been approved in Canada and Europe for the treatment~     of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may~     enhance the movement of the stomach and the small bowel. A recent presentation at a medical~     meeting suggested that prucalopride may accelerate the passage of the capsule camera through~     the small bowel without increasing the chance to miss a lesion in the small bowel.~      The purpose of this study is to asses if the administration of a single dose of prucalopride~     is going to decrease the time required by the capsule to move through the small bowel.~   "
19180|NCT02806193|"~     The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting~     imaging and reporting standards, assessing its diagnostic impact on patient care, and~     determining the cost-effectiveness of CMR imaging. It will be the largest collective body of~     evidence reflecting the current clinical applications in patient care, which healthcare~     payers and governing bodies alike can depend on when metrics such as testing~     appropriateness, common indications, and diagnostic effectiveness are called for. It will~     also be able to reflect any changes in patient impact from CMR over time as technical~     development evolves. Furthermore, it will allow an assessment of improvements in diagnostic~     and therapeutic thinking, risk stratification, and cost-effectiveness relevant to current~     patient management.~   "
19181|NCT02806180|"~     This is a randomized controlled trial comparing the success of US guided peripheral IV~     placement between single vs dual-operator technique among a convenience sample of patients~     with moderate or difficult vascular access in a tertiary care Emergency Department.~   "
19182|NCT02806167|"~     Expedient diagnosis and management of acute cauda equina syndrome (CES) is essential to~     prevent long-term neurological sequelae for these patients. The clinical diagnosis of CES is~     confirmed using magnetic resonance imaging (MRI). However the clinical features of CES~     (secondary to bladder and bowel sphincter dysfunction) are variable and are common~     presenting features of other pathologies of the bladder and bowel, therefore most patients~     who undergo MRI for suspected CES have no compressive lesion evident on the MRI, excluding~     the diagnosis of CES. Urgent MRI scanning performed out of hours is therefore often~     unnecessary, however, the morbidity to the patient due to a delay in diagnosis is so~     significant that urgent MRI scanning is the current gold standard and duty of care in all~     cases of suspected CES. More objective methods of assessing patients with suspected acute~     CES could allow rationing of out of hours MRI scanning and reduce inappropriate admission~     without impacting patient safety.~      The aim of this study is to evaluate the effectiveness of a clinical algorithm which~     utilises digital rectal examination and ultrasound bladder scanning to stratify patients~     into high and low risk groups. Patients considered high risk will be admitted and sent for~     urgent MRI, whereas low risk patients will be discharged and undergo MRI scan within 5 days~     of presentation.~   "
19199|NCT02805946|"~     This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given~     as prophylaxis to patients who are at risk for developing fungal infections after receiving~     conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell~     Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo~     dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and~     determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.~   "
19388|NCT02803463|"~     There has been no consensus over closure versus non closure of peritoneum during abdominal~     operations. The aim of this study is to compare the effect of peritoneal closure versus non~     closure over postoperative pain, early complications and life quality.~   "
19183|NCT02806154|"~     The investigators could hypothesize that age-related changes in body composition parameters~     play a role in the variable tolerance to chemotherapy in the elderly.~      However none of the studies relating body composition and chemotoxicity included elderly as~     a specific subpopulation. Furthermore in the majority of studies, body composition analyses~     are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is~     to date not validated in the elderly cancer patients. Nevertheless some studies used Dual~     Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment~     of body composition in older adults.~      The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of~     the 4 limbs) operationalized as an index by dividing the muscle mass by squared height~     following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass~     of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.~      The finding that body composition is associated with poor tolerance of chemotherapy could~     lead to consider these parameters in the treatment decision of the elderly cancer patients~     and improve the current decision-making algorithms when treating older adults.~   "
19184|NCT02806141|"~     This study is planned to compare the clinical efficacy and safety of aerosolized plus~     intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of~     ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter~     baumannii in the neonates.~   "
19185|NCT02806128|"~     Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute~     anterior circulation cerebral infarction.~   "
19186|NCT02806115|"~     Investigators found that the degree and the duration of aceto-whitening differed between~     gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed~     a severe degree of aceto whiteness and the whitening continued longer than the surrounding~     normal mucosa, which investigators called severe whitening and delayed fading, and~     investigators realized that GIM could possibly be diagnosed by using these differences.The~     aim of this prospective study was to investigate the efficacy of severe whitening and~     delayed fading for diagnosing GIM.~   "
19187|NCT02806102|"~     This study is intended to provide contemporary data on the residual cardiovascular risk in~     all consecutive patients with acute myocardial infarction, especially in patients who~     survived stably within one-year after percutaneous coronary intervention.~      In addition, this study will identify which baseline clinical, angiographic, or treatment~     factors are associated with residual cardiovascular risk and bleeding events~   "
19188|NCT02806089|"~     Aim of this study is to determine in chronic kidney disease patients:~        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C~          reactive protein and decrease in serum albumin) on voluntary muscle strength impairment~        -  the relationship between voluntary muscle strength and muscle mass~        -  the relationship between voluntary muscle strength and lean body mass~        -  the correlation between voluntary muscle strength and physical activity~   "
19189|NCT02806076|"~     The purpose of this study is to prospectively compare the clinical outcomes (local tumor~     progression rate, technical success rate, complication rate) of no touch radiofrequency~     ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor~     puncture RFA technique.~   "
19190|NCT02806063|"~     Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and~     its treatment continues to fuel the debate on how to manage it appropriately.~      One stage and two stage exchange surgery both are the conventional surgical procedures for~     chronic PJI commonly used to date.~      Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional~     impairment between surgeries and a high socio-economic coast) encouraged many surgical teams~     to adopt one stage exchange surgery which provides equivalent or better outcomes. However~     one stage surgery encounters a major conceptual difficulty when it comes to implant the new~     prosthesis in a surgical site microbiologically undetermined and potentially contaminated.~      Investigators suppose the new prosthesis is implanted in a contaminated setting regardless~     of bacteria type and antibiotic therapy duration before arthroplasty.~      The total lack of data answering this question motivated the conception of this prospective~     study in order to describe the microbiological setting where is implanted the new prosthesis~     with one stage exchange surgery after surgical excision and antibiotic therapy initiation in~     chronic PJI.~   "
19191|NCT02806050|"~     The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor~     (ER) presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES)~     positron emission tomography (PET) can be used to predict treatment response to palbociclib~     plus letrozole. As ER expression predicts response to palbociclib in metastatic breast~     cancer patients the investigators hypothesize that lesions with low uptake on FES-PET will~     not respond to the combination of letrozole plus palbociclib.~   "
19192|NCT02806037|"~     Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by~     the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were~     found, the patient does not have the Pathfinder Explorer system applied. If one or more~     lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking~     device is attached to the ultrasound probe, which the surgeon will use to reattempt~     localization of the missing tumor. The Pathfinder Explorer system operates in real-time in~     conjunction with the ultrasound.~   "
19193|NCT02806024|"~     The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is~     effective for reducing blood loss during high risk surgical procedures related to placenta~     previa and placenta accreta. TXA is currently used in other types of surgery for patients~     who are expected to have a large blood loss, such as orthopedic or open heart surgery.~   "
19194|NCT02806011|"~     This is a 3-year (+30 days) long term follow up study to evaluate the safety of~     Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials~     (refer to ClinicalTrials.gov.Identifier: NCT01875081).~      This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic~     liver cirrhosis. Subjects who signed this follow-up observation informed consent form will~     participate in a safety assessment (tumor marker test, occurrence of adverse events and~     serious adverse events, clinical laboratory tests, vital sign, physical examinations.).~   "
19236|NCT02805439|"~     The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as~     adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to~     antidepressant therapy.~   "
19200|NCT02805920|"~     Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic~     method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its~     dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with~     the FNB. This will serve as potential gain for early rehabilitation and thereby functional~     outcome. Adequate direct injection of local anesthetic into the canal will block four~     nerves: the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous~     nerve, and the terminal end of the posterior division of the obturator nerve. Anterior~     cruciate ligament reconstruction (ACLR) is often associated with postoperative severe pain.~     Postoperative early rehabilitation is the primary focus to restore pre-injury status and is~     an essential part of the full recovery, especially that this rehabilitation extents over a 6~     month period. Early elimination of pain is necessary to achieve this goal. However, there~     are no clear conclusive clinical reports defining the adequate analgesic volume-dosage of~     local anesthetic for ACB for postoperative ACL pain management. The investigators speculated~     that volume-dosage manipulation play key role in the effective of ACB for postoperative~     pain. The investigators conducted this prospective, randomized, observer-blinded trial to~     compare 3 combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The~     first aim of the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine~     of the 3 doses as assessed by the visual analog scale (VAS) pain scores. The second aim were~     duration of analgesia, as defined by first demand for analgesia, and subsequent 24-h~     consumption. Physiotherapy tolerance and time to discharge were evaluated. Side effects were~     also assessed.~   "
19201|NCT02805907|"~     Introduction: There are many cross-sectional studies in children and adults indicating that~     low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer~     lung function, decreased response to glucocorticoids and more frequent exacerbations.~     Moreover, as there is a significant group of asthmatic patients having insufficient control~     of their disease, despite high doses of inhaled corticosteroids, we have investigated new~     treatment alternatives, which include vitamin~      Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with~     vitamin D deficiency in degree of asthma control.~      Materials and methods: A prospective, controlled, randomised, triple-blind study was~     conducted with a follow-up of 6 months. The patients recruited were over 18 years of age~     with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels < 30 ng/ml. Patients~     were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements,~     kidney disease (creat. > 2 mg/dl), hypercalcaemia (corrected with proteins > 10.5 mg/dl), a~     repeat episodes of renal colic, any gastrointestinal disease that might interfere with~     vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding.~     The randomisation process assigned patients to one of two groups: a group that received~     vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by~     the oral route) and another group that received placebo in a presentation with an identical~     appearance and the same administration regimen. Demographic, clinical, spirometry and~     laboratory endpoints were collected. The primary endpoint was degree of asthma control as~     determined by the internationally validated Asthma Control Test (ACT). The secondary~     endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as~     measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).~   "
19202|NCT02805894|"~     This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with~     either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will~     receive only EBRT and the other group will receive a Brachytherapy boost and EBRT.Both~     groups will receive treatment with androgen deprivation. There will be 2 consecutive steps,~     a dose escalation and a subsequent dose expansion part.~   "
19203|NCT02805881|"~     Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation~     (CTO-TNS) in Major Depressive Disorder (MDD)~   "
19204|NCT02805868|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug siltuximab is in patients with myelofibrosis (MF). This medication~     has been approved by the FDA for another condition (multicentric castleman's disease (MCD),~     but not for myelofibrosis (MF). In MCD, siltuximab resulted in improvement in symptoms and~     anemia. While MCD and MF are different diseases, they share some common features including a~     protein call interleukin-6 (IL-6) that may be important in causing symptoms of MCD and MF.~   "
19205|NCT02805855|"~     The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal~     stromal cells to treat symptoms of mild to severe knee osteoarthritis.~   "
19206|NCT02805842|"~     Aim The primary objective of this study is to compare medication adherence with medical~     therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.~      Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and~     once-daily tacrolimus groups~      Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily~     regimens, measured in terms of implementation. Secondary outcomes will include graft and~     patient survival, renal function and adverse events. Follow up - 12 months~   "
19207|NCT02805829|"~     This trial is to evaluate the safety and effectiveness of activated and expanded in vitro~     autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2~     overexpressing advanced gastric cancer.~   "
19208|NCT02805816|"~     The investigators will perform prospective observational multicenter study which includes~     children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study~     group) and children without suspicion of CD who underwent gastroscopy for other reasons. The~     investigators will compare sensitivity, specificity and predictive values of several~     serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250,~     Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD~     according to histological findings.~   "
19209|NCT02805803|"~     Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement~     when symptoms duration is greater than 30 days or debridement with modular set replacement~     when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive~     antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients~     and those who refuse reoperation.~      There is limited data available on PSA modality, its tolerance and efficacy, this lack of~     data motivated us to concept a prospective study of long term patient follow up with PJI~     treated with prolonged suppressive antibiotherapy.~   "
19210|NCT02805790|"~     This is a Phase 2, randomized, double-blind, placebo-controlled crossover study which will~     enroll up to 36 subjects (anticipated) with genetically confirmed mitochondrial disease who~     have completed participation in the SPIMM-201 (MMPOWER) study. Subjects will be randomized~     (1:1) to one of two sequence groups: 4-weeks of treatment with 40 mg elamipretide~     administered once daily subcutaneously in Treatment Period 1 followed by 4-weeks of~     treatment with placebo administered once daily subcutaneously in Treatment Period 2~     (separated by 4-week washout period), or vice versa~   "
19211|NCT02805777|"~     As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in~     ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a~     new mask system with diffuse vent technology. This is done by characterizing the mask flow~     over time and compare the performance between patients who apply 2 different washing~     procedures to the mask. The study will also subjectively assess breathing comfort and~     performance of the mask system.~   "
19212|NCT02805751|"~     The purpose of this study is to measure the mechanical properties of the tendon after~     conservative treated Achilles tendon ruptures with or without early controlled loading. This~     is done in a randomized trial and the mechanical properties are measured using roentgen~     stereometric analysis (RSA).~      The hypothesis is that early weightbearing improves mechanical properties of conservative~     treated Achilles tendon ruptures without causing elongation of the tendon.~   "
19213|NCT02805738|"~     A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to~     Evaluate the Efficacy and Safety of CKD-390 tablet~   "
19214|NCT02805725|"~     Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in~     patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose~     (MTD) have been determined (phase I trial).~   "
19215|NCT02805712|"~     This small pilot study will be assessing the the impact of a standardized, social-worker~     led, longitudinal palliative care intervention on alignment of patient and physician~     understanding of prognosis and goals of care. Secondary objectives include assessing the~     impact of this intervention on documentation of advanced care planning and end of life~     preferences, symptom burden, quality of life and health care utilization.~   "
19216|NCT02805699|"~     The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the~     treatment of Combined Pulmonary Fibrosis and Emphysema patients.~   "
19217|NCT02805686|"~     The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be~     detected at the infra-clinical state, when it can still be reversible. Identifying early~     retinal anatomical changes has always represented (a challenge for medical interns,~     dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its~     screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a~     long and tedious exam, offered by only few medical centers. It is recommended to find a~     simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid~     (junction line between, the external and internal photoreceptor segments) using optical~     coherence tomography (OCT-SD) en face enables us, to obtain a panoramic viewing of the~     state of the photoreceptor layer, and to detect any modification, even subtle, within this~     layer. The OCT-SD en face can be easily done by any ophthalmologist who owns one.~      The proportion of en face OCT-SD showing suggestive retinal damage and patients who~     present retinal damage in relation with synthetic antimalarial treatments and diagnosed by~     mfERG is considered in this study.~   "
19218|NCT02805673|"~     At present, the literature does not account for much of scientific data on the assessment of~     osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a~     pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic~     interventions in the treatment of FM, in order to improve the painful experiences of FM~     patients. This study must include 44 patients with FM according to (American College of~     Rheumatology) ACR criteria and followed the University Hospital of Caen.~      The osteopathic care will last eight months and will be followed by a report three months~     after the end of osteopathic interventions. This in order to evaluate the effect in the~     short term and long term, of osteopathic care in patients with FM.~   "
19219|NCT02805660|"~     Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a~     human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or~     PD-L1). Durvalumab is also known as a checkpoint inhibitor.~      This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects~     with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.~      Patients eligible for this study may have previously received treatment with a checkpoint~     inhibitor.~   "
19220|NCT02805647|"~     This study was designed to determine the impact of vitamin D serum levels and vitamin D~     receptor (VDR) polymorphisms on the occurrence of low energy fractures in children.~   "
19221|NCT02805634|"~     The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be~     correlated to performance in the manual dexterity 'nine holes peg' test, within a control~     group and a group of patients with multiple sclerosis.~      TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis:~     magnetic stimulation and electroneuromyography. It is based on the principle of two~     collisions between the descending central stimulation (magnetic stimulation) and the~     ascending peripheric stimulation. TST allows to better quantify central nervous system~     diseases. The abnormal amplitude registered by TST is proportional to the intensity of~     conduction disorders. The evaluation of these disorders is more precise than with the~     magnetic stimulation technique alone.~      The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in~     ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then~     tries to remove them as quickly as possible. The hand must stay in a depression within the~     plate, thereby insuring a constant distance between the hand and the pegs.~      The nine hole peg will be realized first, and the triple stimulation examination performed~     after. The acquired data will be analyzed in order to find a correlation between the~     impairment level given by these two tests.~   "
19222|NCT02805621|"~     Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial~     on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.~   "
19223|NCT02805608|"~     The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG~     PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder~     cancer~   "
19224|NCT02805595|"~     This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus~     tracts in adult patients with hidradenitis suppurativa.~   "
19253|NCT02805218|"~     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients~     with lymphoma receiving chemotherapy.~   "
19254|NCT02805205|"~     The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer receiving chemotherapy.~   "
19225|NCT02805582|"~     The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper~     arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore~     needs to be completed by an intercostobrachial nerve block. The optimal access for an~     ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators~     compare a proximal and a more distal approach to the nerve referred to onset time, sensory~     blocked area and duration.~   "
19226|NCT02805569|"~     Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced~     video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards~     the larynx around the steep blade angulation despite adequate visualization of the glottis.~     Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators~     hypothesized that using articulating stylet (AS) would enhance first attempt intubation,~     shorten the intubation time, reduce the possibility of the soft tissue trauma compared to~     conventional intubation stylet (IS) in patients with difficult airway .~   "
19227|NCT02805556|"~     A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing~   "
19228|NCT02805543|"~     Objective: The main target of this study was to research the early changes of retrobulbar~     and intrarenal hemodynamics, then to research the correlation between them in type 2~     diabetes (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy~     (DR).~      Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy~     people (control group) were recruited to research the early changes of renal function,~     retrobulbar and intrarenal hemodynamics, and then to research the correlation between them.~     The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral~     interlobular renal arteries were evaluated using Doppler Sonographic; the secondary~     endpoints were the retrobulbar hemodynamics RI in the bilateral central retinal artery~     (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using~     color doppler imaging (CDI); the tertiary endpoints were the biochemical endpoints:~     blood-fat (TC, HDL-C, LDL-C, and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN,~     Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio~     (UACR) were measured.~   "
19229|NCT02805530|"~     Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also~     represents the main cause of cancer death. However, it represents the main cause of death by~     cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.~      Various studies suggest that patients who clinically present with a limited number of~     metastases, a term defined as oligometastatic disease, could have a better prognosis of~     survival with a radical treatment, than for their counterparts with a greater number of~     metastasis.~      The purpose of this study is to add more information to the current medical literature about~     the benefits in overall survival of radical treatment of oligometastatic disease in patients~     with NSCLC and equal or less than 5 synchronous metastases at the time of diagnosis.~      The outcomes of the study are to determine the global survival and progression-free survival~     in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC~     undergoing radical treatment of all metastatic sites and the primary tumor.~   "
19230|NCT02805517|"~     This will be a single-arm prospective internally-controlled study. Patients will undergo~     percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm~     instruments are added or substituted for conventional 5 or 10 mm trocars. Multiple outcome~     measures (endpoints) will be measured including time to first opioid use, total inpatient~     opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to~     ambulation, length of hospital stay, presence of any intraoperative or postoperative~     complications, operating time, estimated blood loss, and other routine parameters collected~     in a prospective surgical study~   "
19231|NCT02805504|"~     A prospective, randomized controlled study to determine the efficacy of liposomal~     bupivacaine given by local injection at all the wound sites in patients undergoing urologic~     surgeries.~   "
19232|NCT02805491|"~     Hypospadias is the most frequent malformation of the external genital organs in the male~     infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on~     the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and~     an incompletely formed foreskin. The condition is generally isolated and the aetiology is~     unknown. The pathogenesis is complex and involves hormonal, genetic and environmental~     factors (which are probably interlinked).~      A doubling in the incidence of hypospadias over the last 15 years has emphasized the~     probable role of environment factors: in fact, certain exogenous compounds (collectively~     referred to as endocrine disruptors (EDs)) may modify hormonal functions and thus exert~     harmful effects on the organism or its offspring.~      The male urethra develops between the 8th and 16th weeks of gestation in an~     androgen-dependence manner. In utero exposure of the foetus to EDs may have a~     physiopathological role in the abnormal development of the male genital bud and thus in the~     development of hypospadia. These EDs are present in many different substances, such as~     pesticides.~      Many epidemiological studies have evidenced an increase in the incidence of hypospadias in~     children born to exposed parents. Furthermore, animal studies have identified a certain~     number of compounds associated with hypospadias after in utero exposure. However, human~     foetal samples have very rarely been assayed in an attempt to measure the true level of~     impregnation (i.e. the dose received). At present, it is not possible to draw firm~     conclusions with regard to the true extent of a link between EDs and the increased incidence~     of hypospadia.~      The HypoMeco project is a prospective case-control study.~   "
19233|NCT02805478|"~     This is an observational study of cardiovascular risk factors and arterial or cardiac~     function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of~     age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or~     psychiatric disorders. Study aims include identifying sex-differences in traditional~     cardiovascular risk factors and structural and functional abnormalities in arteries and the~     heart in subjects with overweight or obesity, and how this is influenced by physical~     fitness.~   "
19234|NCT02805465|"~     This study is a multicenter, prospective, randomized cross-over study to compare His Bundle~     Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need~     atrial-ventricular node ablation.~   "
19235|NCT02805452|"~     The purpose of this study is to determine whether Succinate of Solifenacin reduces the~     OverActive Bladder syndrome occurring during prostate irradiation.~   "
19237|NCT02805426|"~     This study is a randomized, double-blind, placebo controlled trial that will enroll 250~     women (125 per study arm).~      The objective of the study is to determine the efficacy and tolerability of oral tranexamic~     acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH).~     Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the~     calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be~     randomized to receive either tranexamic acid or placebo, both in tablet form. All~     participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).~      The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to~     misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding~     without recourse to further treatment in significantly more women.~   "
19238|NCT02805413|"~     Main objective of the experiment is threefold: 1) to technically test a device for central~     blood pressure estimation for its applicability in a spaceflight-related environment and on~     the International Space Station. 2) Furthermore the objective is to compare central blood~     pressure estimates based on arterial pressure readings of different peripheral arteries. For~     central blood pressure estimation mathematical transfer functions as described by~     Karamanoglu and colleagues (11) will be used. 3) Finally the experiments' objective is to~     simultaneously apply phonocardiography together with ECG and carotid plethysmography to~     determine cardiac systolic time intervals in parabolic flight during gravity transitions.~      Secondary objective of the experiment is to simultaneously measure key variables of the~     central circulation during gravity transitions to expand the understanding of cardiovascular~     regulation in weightlessness. Furthermore spirometric measurements shall be performed during~     a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is~     central for cardiovascular regulation.~      Our main hypothesis is that there is no difference between different methods of central~     arteria pressure determination.~      Concerning our secondary objective, this experiment is designed as an observational study.~     Thus no clear hypothesis was generated but the measured cardiovascular and respiratory~     variables will be analysed regarding differences correlated to gravity.~   "
19239|NCT02805400|"~     The main objective of this experiment is to evaluate the alterations in brain cortical~     activity induced by micro- and hypergravity conditions.~      A secondary objective is to correlate changes in brain cortical activity and brain~     oxygenation level with neurocognitive performance.~      Another secondary objective is to differentiate between the influences of hemodynamic and~     electro cortical changes and the influence of stress on cognitive performance alterations~   "
19240|NCT02805387|"~     Dystocic deliveries and the use of bicarbonate~   "
19241|NCT02805374|"~     The objective of this study is to evaluate the effect of food on the pharmacokinetics of a~     single oral dose of ASP1517 in non-elderly healthy adult male subjects.~   "
19242|NCT02805361|"~     REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes~     of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one~     year including the fasting period of Ramadan.~   "
19243|NCT02805348|"~     The objective of this study is to assess the long-term safety and efficacy of bixalomer~     under post-marketed setting.~   "
19244|NCT02805335|"~     PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report~     morbidity with suture as fixation system for PICC (dislodgement, infection) In the~     guidelines it's recommended to use sutureless device. The devices actually used are~     unsatisfactory because of the high risk of migration, accidental removal.~      A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the~     possibility to simplify the after care. This device may stay on patient for 4 weeks. Others~     devices may be changed 1/week.~      The investigators aimed to compare morbidity between this new device and the old one. The~     investigators also want to perform an economic evaluation of this device and compare patient~     quality of life.~   "
19245|NCT02805322|"~     Quantify the reliability and agreement of estimated core body temperature using the~     InstaTemp MD™ and other widely marketed reference Thermometers~   "
19246|NCT02805309|"~     Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older~     adults with severe symptomatic aortic stenosis who are considered high risk for surgical~     aortic valve replacement. Despite symptomatic and survival benefits, many patients~     experience functional decline after TAVR. This pilot study aims to test the feasibility of a~     home-based exercise intervention targeting endurance, strength, and balance as well as~     cognitive behavioral intervention to improve physical functioning and disability after TAVR.~   "
19247|NCT02805296|"~     Intensive phototherapy in form of double light is used worldwide in the treatment of severe~     neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the~     efficiency of phototherapy. This study investigates whether double phototherapy reduces~     total serum bilirubin faster than single light during intensive phototherapy, using light~     emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.~   "
19248|NCT02805283|"~     The purpose of this study is to evaluate the diabetes related treatment satisfaction for~     patients with type 2 diabetes mellitus.~   "
19249|NCT02805270|"~     The implementation of a medication reconciliation intervention including: medication~     reconciliation on admission and discharge, bedside medication counselling and take-home~     medication list, on the development of adverse drug events within 30 days post discharge as~     primary outcome. Secondary outcome is the evaluation of its impact on health care resource~     utilization~   "
19250|NCT02805257|"~     This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed~     valve implantation. Approximately 100 patients will be enrolled, with half receiving the~     Mitomycin-C treatment and the other half receiving placebo treatment.~   "
19251|NCT02805244|"~     A mass balance study to determine the routes and rates of elimination of radioactivity, to~     determine total radioactivity in plasma and whole blood over time and compare levels to~     JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters~     of JTZ-951 and its metabolite(s).~   "
19252|NCT02805231|"~     This study investigated whether vitamin D receptor gene polymorphism is altered in primary~     open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients~     and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic~     analysis was studied by polymerase chain reaction-restriction fragment length polymorphism~     technique.~   "
19255|NCT02805192|"~     Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of~     medication if a valid weight or age is entered. During emergency situations, these values~     are often unknown. An App has been developed to measure the size of a child noninvasively.~     This App is now to be validated in clinical practice. App measured size is calculated and~     compared to the real size of a child. Via known percentiles of age/weight of the child is~     calculated upon the App measured size. This value is compared to the mother`s, physician`s~     and nurses estimation of the size and weight.~      Depending on the size multiple algorithms exist to estimate weight, age and medical values.~     (Kindersicher ®, Notfalllineal ® and Broselow Tape ®). These estimations by the~     calculations will also be compared to actual weight and age.~      Children from 0-12 years of age are included in the emergency Department of the Children`s~     Hospital of the University of Zurich after informed consent obtained by the parents. No~     therapy decisions from these calculations will be made. The therapy is independent of this~     study.~   "
19256|NCT02805179|"~     This is a study to determine the safety and effectiveness of high-dose radiation therapy~     (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.~   "
19257|NCT02805166|"~     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients~     with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving~     multi-cycle chemotherapy.~   "
19258|NCT02805153|"~     The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer receiving chemotherapy~   "
19259|NCT02805140|"~     The purpose of this study is to test feasibility and acceptability of an online platform~     that uses mobile apps and videoconferencing tools to increase activity levels in mothers~     with young children.~   "
19260|NCT02805127|"~     This is an observational study which aims to evaluate the possibility of using data from a~     capnography device to assess obstructive airway severity in both Chronic Obstructive~     Pulmonary Disease (COPD) and Asthma patients.~   "
19261|NCT02805114|"~     This is an observational study which aims to evaluate the possibility of using data from a~     capnography device to assess obstructive airway severity in both Chronic Obstructive~     Pulmonary Disease (COPD) and Asthma patients.~   "
19262|NCT02805101|"~     This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two~     materials are going to be tested in sealing accidental root perforations at the bifurcation~     areas. The study is going to be conducted as a randomized controlled trial.~   "
19263|NCT02805088|"~     The initial aim of the project was to gain an understanding of the comprehension of~     language-oriented emotions among schizophrenic and bipolar patients. By~     language-oriented emotions, the investigators mean the emotions that are conveyed by means~     of language, whether through the emotional valence of the words, the expression of an~     emotional state or emotional prosody. Although they involve different diagnostic categories,~     schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular~     in the emotional sphere, and do so to such an extent that the question of whether there may,~     at the clinical, cognitive and etiopathogenic levels, exist a continuum between these~     disorders is frequently raised. Taking this hypothesis of a clinical continuum as our~     starting point, the investigators explored the understanding of emotions contextualized by~     language in these two clinical populations, namely patients exhibiting schizophrenic and~     bipolar disorders. To these populations, the investigators also added the dimension of~     vulnerability in the form of non-clinical participants varying in terms of their traits of~     schizotypy and hypomania, thus orienting this project toward the early identification of~     cognitive-emotional markers and possibly also their prevention.~   "
19264|NCT02805075|"~     This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in~     treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes~     the transplanted cells from a donor can make an immune response against the body's normal~     cells (called graft-versus-host disease). Nutritional supplements such as~     fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients~     with blood cancer undergoing donor stem cell transplant.~   "
19265|NCT02805062|"~     Malignant pleural effusion is a common clinical problem with median survival of~     approximately 6 months thus efficient management of Malignant pleural effusion is important.~     In patients with a Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural~     catheter should be inserted instead. Accurate detection of Trapped Lung prior to insertion~     would avoid futile attempts at talc pleurodesis, re-intervention following failed~     pleurodesis and allow adequate time to plan for an indwelling pleural catheter~     insertion.Pleural manometry allows direct and objective measurement of intra-pleural~     pressure during pleural fluid aspiration.The primary aim of this study is to determine~     whether the addition of digital pleural manometry to clinical judgment, prior to and during~     local anaesthetic thoracoscopy, results in a clinically meaningful improvement in Trapped~     Lung detection.~   "
19266|NCT02805049|"~     The main objective of this study is to describe the pharmacokinetics of the prescribed~     echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal~     infection is suspected or proven.~   "
19267|NCT02805036|"~     Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar~     recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care~     for decreasing morbidity associated with mechanical ventilation.~      In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from~     one centre to another and from one study to another.~      The investigators intend to compare two currently used AR techniques with regard to their~     ventilatory efficacy and hemodynamic safety:~        -  An end-tidal plateau at 30 cmH20 for 30 seconds.~        -  An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds,~          without exceeding 30 cmH20.~   "
19268|NCT02805023|"~     Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells~     enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic~     stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from~     peripheral arterial disease (PAD) with critical limb ischemia (CLI) who have not responded~     to optimal pharmacological treatment or control of risk factors and/or had a~     revascularization failure, and do not have the option of further revascularization~     treatment.~   "
19270|NCT02804997|"~     The great majority of cardiac surgery patients develop a degree of post-operatory~     respiratory failure. This is due to several factors. The predominant element in the onset of~     this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by~     peroperative hypoventilation (in the presence or absence of ECC). The incidence has been~     evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive~     ventilation) might (through the application of continuous positive expiratory pressure) help~     to counter the development of these atelectasic foci.~   "
19271|NCT02804984|"~     The project's objective is to identify and characterize somatic mutations in cases of~     idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects~     found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS~     may be a precursor of MDS. To this end, high-throughput exon sequencing (using~     next-generation sequencing (NGS)) will be used to target the genes known to be mutated in~     MDS. This study is important for two reasons. Firstly, it will help to optimise the clinical~     monitoring of patients with molecular defects and considered to be at risk of progression.~     Secondly, it will provide a better understanding of the fundamental molecular mechanisms~     underlying the progression of ICUS to MDS.~   "
19272|NCT02804971|"~     Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with~     inflammation, which leads to a progressive lung deterioration. This disease is responsible~     for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of~     hospitalization. Natural history is marked by recurrent infectious diseases which are the~     main prognosis factor. This disease is associated with an inflammation rate in the lung as~     well as in the blood. Up to now, no study has been described comorbidities associated with~     this chronic disease but our hypothesis is that cardiovascular diseases will be more~     frequent in these patients. In fact systemic inflammation driven by bronchial infections may~     increase frequency of cardiovascular diseases.~      The investigators decide to conduct a monocentric observational study to define the~     prevalence and characterization of cardiovascular comorbidities as well as markers of~     accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities~     are frequent in bronchiectasis and may be associated with markers of inflammation and aging.~      Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement~     according to the ATS/ERS guideline. 6M walking test and echocardiography will be also~     performed.~      Frequency of comorbidities will be calculated with data from questionnaire as well as~     standardized explorations.~      Aging related manifestations will be measured: arterial stiffness using aortic pulse wave~     velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal~     muscle mass and grip test were also performed.~      Blood test were also performed to measure inflammatory markers, cytokines and length of~     telomere in circulating leucocytes.~   "
19273|NCT02804958|"~     INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for~     acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective,~     observational, 4-regional-hospital based registry reflecting current practices of~     management, risk factors, and clinical outcomes in patients with ST-segment elevation~     myocardial infarction undergoing primary percutaneous coronary intervention at cities of~     Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and~     2014.~   "
19274|NCT02804945|"~     The goal of this clinical research study is to learn about the safety of giving mesenchymal~     stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells~     can help control ARDS when given with drugs that are routinely used to treat ARDS.~      In this study, all participants will receive standard of care treatment for ARDs, and some~     participants will receive standard of care treatment and MSCs.~   "
19275|NCT02804932|"~     The purpose of this study is to use a randomized, double-blind, placebo controlled study~     design to comprehensively investigate the impact of 8-weeks of dietary nitrate~     supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity~     in patients with type 2 diabetes (T2D).~   "
19276|NCT02804919|"~     The study is to evaluate the product reliability, therapy effectiveness and user feedback of~     a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.~   "
19277|NCT02804906|"~     This pilot feasibility study will test whether a home-based cardiac rehabilitation~     intervention, using physical therapist visits combined with mobile health technology, will~     prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants~     will be randomized to either an intervention arm (home-based physical therapy), or a control~     (usual care) arm. Prior to discharge, participants in the intervention arm will receive a~     1-hour educational session by a research physical therapist that includes information on~     cardiac risk factor management, postoperative recovery, education on medication adherence,~     and a prescription for home exercise that is tailored to each patient's baseline abilities~     and limitations. Participants assigned to the control arm will receive a 30-minute~     counseling session on risk factor modification prior to discharge, in addition to usual care~     post-AMI.~   "
19278|NCT02804893|"~     This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies~     and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected~     recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major~     lung resections performed using one of the two techniques for participation in the study.~     Each participating centers should have the possibility to offer both techniques (Robotics~     and Vats). The primary end point is a combination of conversion and complication rate. The~     presence of at least one of the two events is considered a failure. Considering the rate of~     failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm,~     so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.~   "
19279|NCT02804880|"~     The present study will examine (1) the effectiveness of personalised active referral to~     smoking cessation (SC) services and text messaging on encouraging SC services (2) explore~     the use of CBPR model to build capacity and to engage community partners in taking on this~     important public health issue for sustainability in the community. In addition, process~     evaluation will be conducted to assess the effectiveness of the recruitment activity and how~     it is linked with the overall program outcomes.~   "
19389|NCT02803450|"~     This prospective, randomized, single blinded control trial will investigate the effects of~     epidural loading with a high volume, low concentration local anesthetic solution via the~     epidural needle versus the epidural catheter.~   "
19281|NCT02804854|"~     Critically ill patients often succumb to acute respiratory disease (rapidly developing~     disease affecting the lungs). The lungs are the commonest organ to fail and require support~     in the intensive care environment. However, no accurate methods exist that can be used at~     the bedside to tell what is causing deterioration in a person's lungs. There are various~     examples of acute respiratory diseases that can occur as a result of numerous different~     causes, have a high risk of death and cannot be treated easily with drugs. When trying to~     accurately diagnose and classify these lung diseases there is a risk that the type of~     respiratory disease is misdiagnosed, missed or the level of severity is not captured. By~     using the field of optical molecular imaging and employing novel techniques and~     technologies, the investigators hope to demonstrate here that a bespoke chemical probe~     administered in micro doses (tiny doses) directly into the distal lung can rapidly and~     accurately detect activated neutrophils (cells of the immune system that are implicated in~     the development of these severe conditions), and so work towards a bedside test which could~     be used to diagnose, monitor and classify the disease in patients who are critically ill in~     the future. The population for this study are in intensive care where patients are normally~     intubated (have a breathing tube) due to the severity of their illness, this may be because~     of respiratory problems or respiratory problems can rapidly develop. Participants will have~     the chemical probe administered into their lungs and pictures taken through the tube already~     in place. As this probe lights up when it comes into contact with neutrophils the~     investigators will be able to tell if neutrophils are present. This will inform a larger~     study in which it's hoped that the method can be used to inform clinical decisions. The~     first procedure will take place within two days of initiation of mechanical ventilation and~     the direct contact with the study team will be completed within nine days.~   "
19282|NCT02804841|"~     Ireland is predicted to have the highest older adult population growth of any European Union~     country. A substantial economic and social challenge of this projected growth is the~     increased incidence of cognitive impairment and the likelihood of progression to dementia.~     Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain~     changes identifiable from the earliest stages of neuropathology, providing an opportunity~     for intervention. Switching to a strategy of earlier identification and prevention would~     significantly reduce prevalence and the associated cost.~      The purpose of this pilot study is to evaluate the use of vitamin D supplements in community~     dwelling older adults as a lifestyle approach that may support cognitive and physical~     functioning. The research will incorporate several stages including an initial in-depth~     screening process, a novel and sensitive cognitive battery, 6 month double blind placebo~     controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant~     feedback interview.~      These results will be used to assess the feasibility of recruiting and assessing community~     dwelling older adults for extensive nutrition related cognitive studies.~   "
19283|NCT02804828|"~     The purpose of this study is to develop preliminary evidence, such as effect size and~     variance estimates, to guide successful conduct of a properly-powered clinical trial to~     assess the benefit of a mitochondrial cocktail plus individualized correction of citric acid~     cycle (CAC) intermediates and amino acid (AA) abnormalities as part of a~     mitochondrial/oxidative stress treatment approach in Gulf War Illness (GWI).~   "
19284|NCT02804815|"~     Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can~     prevent recurrence and improve survival in individuals with non-metastatic common tumours.~     The question will be assessed in four different tumour types (breast, colorectal,~     gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial~     protocol.~      Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg,~     aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease~     recurrence and survival will be assessed, along with adherence, toxicity, and other~     potential effects of aspirin (eg. cardiovascular).~      There is a large body of evidence indicating that aspirin has anti-cancer effects.~     Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer~     mortality and a decrease in risk of metastases, suggesting a role for aspirin in the~     treatment as well as prevention of cancer. Additionally, large observational studies of~     individuals taking aspirin after cancer treatment have shown improved disease-specific and~     overall mortality for specific tumour types.~      In the treatment setting, the risks of side effects associated with aspirin are expected to~     be outweighed by potential benefits. However, this has not yet been assessed in a randomised~     trial.~      As a low cost, generic and widely available drug, which is generally safe, if aspirin is~     shown to be effective, it could have a huge impact on cancer outcomes globally.~   "
19285|NCT02804802|"~     The main purpose of our project is to construct a lifestyle score based on a short~     questionnaire easy to complete and to validate it among participants in mass screening for~     colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We~     will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed~     by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive).~     Colorectal cancer will be the primary outcome for the assessment of the score's performance.~     The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure.~     Our secondary objectives are to test a second weighting system, evaluate the benefit in~     terms of predictive performance to add to the lifestyle score other dietary factors among~     that have a probable link with the risk of colorectal cancer, determine the acceptability of~     the questionnaire and to estimate by a cost-utility analysis the impact of applying a~     strategy of targeted screening using the developed score.~   "
19286|NCT02804789|"~     Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's~     Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease~     at its very earliest stages when in theory treatments are most likely to be successful in~     preventing further spread of the disease in the brain and causing dementia. The aim of EPAD~     programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major~     component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide~     subjects for the EPAD trial as well as data to improve understanding of disease before~     dementia develops.~      The Investigators will approach a broad range of people over the age of 50 who have~     previously taken part in various research studies and consented to being recontacted for~     further research. Participants will be asked questions to assess their memory and other~     cognitive function. The participants will also undertake a brain scan, provide a sample of~     spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may~     change in Alzheimer's disease. The Investigators will then follow these participants until~     December 2019 repeating these tests annually. This will be called the EPAD Longitudinal~     Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the~     Investigators understand more about what happens to people before dementia develops, and to~     help recruit people more quickly into the EPAD trials of new medications or other~     interventions expected to prevent dementia.~      People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention~     studies to see if interventions can modify the probability of developing dementia or~     cognitive problems (this will be subject to separate ethics approval and consent). Together~     EPAD LCS and EPAD PoC make up the full EPAD Programme.~   "
19287|NCT02804776|"~     This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for~     patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation~     lung cancer.~   "
19288|NCT02804763|"~     The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab~     Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic~     Lupus Erythematosus receiving stable standard-of-care medications.~   "
19289|NCT02804750|"~     Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels~     of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated~     endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from~     cortisol overproduction by the adrenal glands is the subject of this protocol.~      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic~     administration of high doses of glucocorticoids, are not eligible for enrollment in this~     study.~      The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment~     of endogenous Cushing's syndrome. The multicenter study will be conducted in the United~     States and in Europe.~   "
19290|NCT02804737|"~     The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used~     web-based instructions at St. Paul's Hospital.~   "
19291|NCT02804724|"~     Human immunodeficiency virus (HIV) is a major global health concern which has resulted in an~     estimated 39 million deaths world-wide. Although it is now a treatable medical condition~     there is still avoidable morbidity and mortality associated with HIV infection in the UK.~     Late diagnosis (CD4 count of <350 cells/mm3 or AIDS-defining illness irrespective of CD4~     count) is associated with increased morbidity and mortality, increased risk of transmission,~     impaired response to antiretroviral therapy and increased healthcare costs. In Grampian, 49%~     of patients were diagnosed late between 1984 and 2011. Therefore, the aim of the study is to~     determine the factors associated with late HIV diagnosis in Grampian between 2009 and 2014~     to ascertain whether diagnoses could have been made earlier.~      The study constitutes a secondary data analysis. Individuals newly diagnosed with HIV~     between January 2009 and December 2014 were identified from a Health Protection Scotland~     (HPS) database. The majority of outcome data were extracted from the existing HPS database.~     Missing data were collected via a retrospective review of patient case-notes, laboratory~     reports and an electronic patient management system. Patients were classified as early or~     late diagnosis and comparisons were made between the groups using statistical tests. The~     study sought to provide a basis for recommendations for improvement of information and~     services to facilitate earlier HIV diagnosis in Grampian.~   "
19292|NCT02804711|"~     Before this study, there will be an open-label, dose-escalation pilot study with a total of~     30 participants with 10 per dosage group. The aim of the pilot study is to explore the~     preliminary safety of an experimental recombinant staphylococcus aureus vaccine.~      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial. This study will determine the safety and side-effect profile, and immunogenicity of~     an experimental recombinant staphylococcus aureus vaccine. The study will be carried out~     following a dose-escalation method from the low dosage to the high dosage, i.e. the higher~     dosage vaccine could only be administrated after the first seven-day safety of the lower~     dosage vaccine is confirmed after safety observation.~   "
19293|NCT02804698|"~     This project will look to improve standards of care for diabetic patients by evaluating a~     program that supports participants in making healthy lifestyle changes.~      The program consists of 13 educational sessions that contain information about the~     prevention and care of diabetes and cardiovascular disease, physical activity, nutrition,~     community health and emotional well being.~   "
19294|NCT02804685|"~     This research presents a randomized clinical trial which evaluates the effectiveness of an~     exercise protocol on the knee-joint repositioning in futsal players related to a post-match~     muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position~     before and after the match when performing our exercise program.~   "
19295|NCT02804672|"~     The purpose of this study is to examine the association between ideal cardiovascular health,~     diet and other lifestyles, biological risk factors, either well-established or emergent, and~     the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015~     -16).~   "
19296|NCT02804659|"~     Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid~     status.~   "
19297|NCT02804646|"~     The purpose of this study is to discuss the efficacy and safety of recombinant human~     endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus~     cisplatin or carboplatin in the first-line treatment of advanced lung adenocarcinoma with~     wild-type EGFR or ALK-negative,compared with chemotherapy without endostar.~   "
19298|NCT02804633|"~     The investigators hypothesis is that use of IV acetaminophen will significantly decrease use~     of post-operative opioid consumption and enhances recovery after colorectal surgery.~   "
19299|NCT02804620|"~     This study is a 12-month study. There are two different groups in the study. Both groups~     will enter the study after the graduation from 8-hour diabetes education course taught at~     VGH, St. Paul's, or Richmond Hospital. The first group will receive on-going support from~     their peers who have diabetes and are trained specifically to help other patients with~     diabetes. The second group will receive the usual care.~   "
19300|NCT02804607|"~     Traumatic skin lesions and in particular the burns which happen to growing children are~     complex and require an adapted and early patient care management. A child presents physical,~     psychological, and physiological characteristics which involve a specific functional~     prognosis. The aim of the study was to evaluate the functional outcome after a mid-term~     period from a severe skin traumatism occurring during childhood and which had required an~     initial graft.~   "
19301|NCT02804594|"~     This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center~     trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive~     MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be~     randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three~     times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and~     week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing~     last study drug dose). Visits will all occur in the morning to maximize consistency of~     assessments and evaluate main outcomes within 2 hours of morning dose of study medication.~     Fatigue questionnaires, and research samples will be obtained before neurological~     examination, or magnetic resonance imaging. Research blood draws will be obtained just after~     fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours~     after morning dose of study drug to maximize detection of the biological effect of study~     medication.~   "
19302|NCT02804581|"~     Gum Arabic (GA) rich dietary fiber it is a water-soluble dietary fiber derived from the~     dried gummy exudates of the stems and branches of Acacia senegal, GA found to have strong~     immuno modulator in vitro where it increased IL10 production showing strong~     anti-inflammatory effects (19).~      The aim of this study is to determine the role of gum Arabic in immunomodulation among~     patients with rheumatoid arthritis.~   "
19303|NCT02804568|"~     This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine~     and samidorphan in adults with schizophrenia following 14 consecutive days of oral~     administration of ALKS 3831.~   "
19304|NCT02804555|"~     In this study the investigators examine the effects of intraoperative oxygen administration~     to the mother on certain enzyme functions of the newborn. With this object blood samples are~     taken from the newborn's umbilical chord - which is otherwise a routine practice at the~     investigators clinic - and the mother's radial artery in parallel with umbilical clamping~     and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally~     in a properly equipped laboratory.~   "
19305|NCT02804542|"~     The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca~     blocks performed in the emergency department are effective for preoperative analgesia in hip~     fracture patients. Investigators hypothesize that patients with these blocks will have lower~     opioid requirements than patients in a historical group in whom blocks were not performed.~   "
19306|NCT02804529|"~     The Palmer's point and periumbilical region are the common laparoscopic entry site to~     establish the pneumoperitoneum. In the present study, the investigators assess the safety~     and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the~     gastrointestinal surgery.~      This prospective and randomized study will compare the three entry techniques with regard~     to:~        -  Complications related to the entry technique~        -  Time taken to enter the abdomen.~        -  The number of attempts taken to enter the abdomen~   "
19307|NCT02804516|"~     Despite evidence to support early mobilization（EM）for critically ill patients,current status~     in Chinese ICUs is unknown.Understanding current practice patterns and challenges is~     essential to inform future research and strategies.~   "
19308|NCT02804503|"~     Most studies on menu labels have been conducted in mostly non-Hispanic white individuals,~     and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly~     understood. This study evaluated the impact of menu labels on calories and macronutrients~     ordered in Hispanics.~   "
19309|NCT02804490|"~     The purpose of this randomized control trial is to test the impact of provitamin A~     carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.~   "
19310|NCT02804477|"~     This study aims at finding degree of adherence of patients to their chronic pain medication~     prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8,~     self- reported questionnaire. Also relationship of various demographic, disease related and~     opioid related factors to medication adherence.~   "
19311|NCT02804464|"~     Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on~     plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell~     transplant patients when compared with standard clinical diagnostics~   "
19312|NCT02804451|"~     The aim of the study was to compare the intubation time and effectiveness, the grade of~     larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices:~     a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and~     ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.~   "
19313|NCT02804438|"~     The purpose of this study is to collect a large amount of data that may assist in addressing~     the gap in knowledge of understanding pupillometer readings using a pupillometer device.~      The aim of this project is to establish normative values for pupillometer data. Measures of~     central tendency will be developed for the variables provided by automated pupillary exams,~     which will provide an enhanced understanding of clinically appropriate pupil values for~     size, reactivity, and neurological pupil index.~   "
19314|NCT02804425|"~     The use of simulation in medical education has been associated with positive results in the~     acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al,~     high-fidelity simulation provides concrete experience that is the basis for self-reflection,~     further experimentation and immersive learning named experiential learning. However the~     important number of learners and the extensive human resources required to deliver mannequin~     patient-based simulation limit its use for initial and repeated training. In general, 2-4~     trainees participate in each scenario while others may look at the progress of the scene~     through video transmission in a neighboring room while all trainees met thereafter for the~     debriefing. In typical learning sessions, all trainees act as a participant at least once.~     However, due to the increasing number of trainees, the investigators anticipate that some~     trainees might remain spectators during the whole simulation session.~      In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for~     all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established~     a few years ago. Each session includes a one-day training with 4 different immersive~     scenarios using a high fidelity mannequin. Each scenario is attended by 3 residents. In~     years before 2014, the number of anesthesia residents to be trained was 35 and each of them~     could play the role of an actor at least once in the session (actor-spectator). In a~     previous preliminary study, the investigators found that the learning outcomes were similar~     for all residents at the end of the day, whatever the scenario in which they had played and~     those scenarios for which they had remained spectators. This led to the hypothesis that~     being an actor in a scenario might be less important than attending the whole session and~     participating in all debriefings. However, to our knowledge, few study has explored the~     outcomes of the learning process for spectators-only.~      The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints~     and limitation in the number of trained teachers, the investigators see that inevitably,~     several trainees will remain spectators during the whole session. The purpose of this study~     is thus to determine whether the status of the learner (actor-spectator vs spectator-only)~     during an immersive simulation has an impact of learning outcomes.~   "
19315|NCT02804412|"~     Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has~     remained unclear, however, whether intensity of therapy or constraint is the relevant~     factor. This study will give an answer to this question to improve speech and language~     therapy.~   "
19316|NCT02804399|"~     The purpose of this study is to estimate the effect of rifampin on the single dose PK of~     PF-06463922.~   "
19317|NCT02804386|"~     Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon~     among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of~     Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention~     Model: Treatment agents (non-interventional observational study): Real life clinical~     practice study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months~     Study Centre Multi centric Study~   "
19390|NCT02803437|"~     This study is a Japanese post-marketing surveillance (PMS) which is required by the~     regulatory authorities. General objective of PMS is to confirm the clinical usefulness,~     especially the safety profile of a drug under the routine clinical practice.~   "
19318|NCT02804373|"~     The investigator thinks that the oxytocin (OT) can improve durably and significantly the~     behavior disorders and thus the socialization but also the satisfaction and could thus be an~     interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome~     (SPW). Although today several studies demonstrated the effects of the OT in various domains~     of the behavior, the investigator do not know either its specificity of action about the~     cerebral level, or its duration of action, or the optimal modalities of administration and~     in particular at patients SPW.~   "
19319|NCT02804360|"~     Purpose: Cystoid macular edema (CME) in retinitis pigmentosa (RP) has been managed in~     several ways with little success. The aim of our study was to report the use of intravitreal~     dexamethasone implant in a large series of patients with RP and CME.~      Setting: Retrospective case series. Methods: Cases were diagnosed as RP based on the classic~     fundus triad of bone-spicule pigment deposits (intraretinal pigmentary migration), retinal~     vessel attenuation, waxy pallor of the optic disc along with night blindness and attenuated~     ERG amplitudes (delays in rod or cone b-wave implicit times). Family history of RP and~     family screening for RP were important in establishing the diagnosis in eyes with some~     diagnostic challenge. CME was diagnosed by intravitreous fluorescein angiography IVFA and~     spectral domain optical coherence tomography (SD-OCT). BCVA was monitored using Snellen~     visual acuity chart and CME was monitored by SD-OCT on follow-up visits.~   "
19320|NCT02804347|"~     The sense of smell and cognition are known to be closely associated with mood and emotional~     processes. However, despite the clear links between olfaction and cognitive processes with~     emotional states, research into the role of olfaction, cognition, and mood disorders has so~     far yielded variable results. This study proposes to investigate the ability to detect and~     identify odours and assess cognition in a group of patients with unipolar and bipolar~     depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or~     intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated~     utilizing standard olfactory testing protocols using commercially available kits. Cognition~     will be evaluated utilizing standard cognitive test protocols in a functional magnetic~     resonance imaging protocol. The results will potentially shed light on the link between~     olfaction, cognition and mood disorders.~   "
19321|NCT02804334|"~     The goal of this project is to study ~45 molecules in blood cells that may differentiate~     patients with bipolar disorder from healthy controls.~   "
19322|NCT02804321|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing~     prevalence. Two main techniques are used today to restore sinus rhythm: electrical~     cardioversion and radiofrequency ablation.~      Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a~     relatively high success rate (about 80%), a substantial number of patients require a second~     procedure to obtain sinus rhythm. Many publications have led to the study of predictors of~     failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to~     date no parameter is reliable and usable in daily practice.~      It is the same for electrical cardioversion. Despite a relatively high immediate success~     rate of approximately 80%, a significant number of patient relapse arrhythmia in short and~     long term. Many publications have led to the study of predictive factors of failure~     (seniority and type of AF, uncontrolled hypertension, size of the OG, mitral valve~     disease...) but so far the results are disappointing.~      In AF patients with heart disease underlying, it has been well demonstrated that the~     renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well~     established that elevated plasma aldosterone as in primary hyperaldosteronism is associated~     with a significantly increased risk of occurrence of cardiovascular events. The high plasma~     concentrations were also highlighted in the acute phase of myocardial infarction, or heart~     failure and are associated with an increase in major cardiovascular event rate, especially~     arrhythmias. In some experimental models of heart failure, it has been demonstrated a~     suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The~     arrhythmogenic effect of aldosterone has also been shown in animal models. All these results~     indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and~     the FA.~      The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is~     predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias~     (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency~     ablation or via electrical cardioversion.~   "
19323|NCT02804308|"~     Breast cancer is a multifactorial disease affecting women, and one of the treatments for its~     healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs~     that promote lower chance of metastasis, but their side effects include the loss of bone~     mineral density and increased fat percentage. In this way, the Combined Training (combined~     resistance and endurance training) may be an interesting strategy to minimize the side~     effects of aromatase inhibitors, providing better quality of life, survival and changes in~     body composition.~   "
19324|NCT02804295|"~     Injured trauma patients in the Emergency Department (ED) may be a particularly important~     group to target for screening and intervention for prescription drug misuse (PDM). These~     patients have high rates of psychiatric and substance use co-morbidity and pain management~     for their injuries (e.g. broken bones, burns) will often require prescribed opioid pain~     medications and other controlled substances. To date, there are no effective ED-based~     interventions for PDM. Collaborative Care is a longitudinal model of care that combines~     multiple elements for patients with complex medical comorbidities. This model holds promise~     as an intervention strategy for injured patients in the ED that are at risk for prescription~     drug misuses. Collaborative Care from the ED is innovative and requires developing follow up~     procedures on a population that has previously been difficult to follow and may have~     previously avoided consistent health care delivery. The primary objective of this study was~     to determine the feasibility of initiating a collaborative care intervention for injured ED~     patients with PDM by enrolling patients into an open trial of this intervention. A secondary~     objective was to determine if PDM decreases over time after enrollment and developing~     successful follow-up procedures to deliver longitudinal care.~   "
19325|NCT02804282|"~     The proposed single-dose study aims to evaluate the product design clinical performance of~     the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination~     Product, in adult Subjects previously diagnosed with mild to advanced heart failure.~      The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose~     equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the~     sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.~      The objectives of this study are:~        -  To demonstrate that the to-be-marketed drug-device combination product performs as~          intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area~        -  To assess safety and local tolerance of the drug-device combination product~   "
19326|NCT02804269|"~     Biobank is a program which collects biological samples, health information and imaging data~     from consented patients and stored them at the core facility. These information would be~     used to study the molecular, imaging and outcome studies of cardiovascular health and~     disease.~   "
19422|NCT02803021|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19327|NCT02804256|"~     The National Heart Centre Singapore has recently created a biorepository that is IRB~     approved for the use in genetic studies: molecular and imaging studies of cardiovascular~     health and disease (CIRB Ref: 2013/605/C). This repository enables IRB approved projects~     within the National Heart Centre Singapore to access the samples for use in biomarker or~     genetic studies with consent from patients for these studies. The IRB approved biorepository~     process also allows for patients, when they have consented to this, to be approached for~     inclusion in additional studies at National Heart Centre Singapore.~      In this study, the investigators will examine the genetic variation in genes known to cause~     inherited cardiac conditions and also look for circulating biomarkers (ICC) in 600 patients~     with ICC and in 500 patients with ischemic heart disease (e.g.IHD) who will be used as~     controls. Healthy controls will also be used (800) as they become available in the~     biorepository. All samples have already been collected in the NHCS biorepository.~      These patients would have been recruited and consented to the biorepository. This will~     enable all to better understand heart disease in Singaporean patients. In addition, the~     investigators will invite a subset of 10 patients with ICCs to provide a second blood sample~     (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository.~     The second blood sample will be used for antibody biomarkers that will be developed in the~     basic science laboratories. These antibodies will be used to develop new biomarkers of human~     heart disease to improve human health.~   "
19328|NCT02804243|"~     The purpose of this study is to compare the exercise endurance between oxygen therapy with~     rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic~     respiratory failure receiving long-term oxygen therapy.~   "
19329|NCT02804230|"~     The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness~     of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of~     patients suffering from medication-refractory epilepsy, using the ExAblate transcranial~     system to produce multiple sonications targeted in the lesion of interest. The investigators~     will establish the feasibility and collect data to establish the basic safety of this type~     of treatment as the basis for later studies that will evaluate its full clinical efficacy.~   "
19330|NCT02804217|"~     Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial~     growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR~     tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be~     helpful for guiding the subsequent treatment. This study aimed to analyze the genetic~     profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next~     generation sequencing (NGS).~   "
19331|NCT02804204|"~     Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor,~     cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential~     predictors in the response to the treatment with anti-TNF in patients with rheumatoid~     arthritis after 24 weeks of treatment.~   "
19332|NCT02804191|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to~     Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe~     Conjunctivochalasis~   "
19333|NCT02804178|"~     This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and~     efficacy of orally administered ATR-101 in subjects with classic congenital adrenal~     hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to~     6 months per subject. A subject may receive a minimum of one dose level or up to a maximum~     of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28~     days.~   "
19334|NCT02804165|"~     Type 1 diabetes (T1D) is the most common endocrine disorder in children. In France, T1D~     prevalence is estimated to 12.2 per 100 000. Worldwide T1D incidence increased rapidly in~     the last decades, around 3% per year. T1D is caused by autoimmune destruction of pancreatic~     beta cells, leading to hyperglycaemia. T1D was recently associated an important loss in life~     expectancy compared with the general population. To date, the precise aetiology of T1D onset~     and the mechanisms involved in T1D remain unknown and no preventive treatment of T1D exists.~      It is now well admitted that T1D results from a combined effect of genes, environmental~     factors and gene-environment interactions. Several genetic factors have been reported as~     associated to T1D, the most important being the human leukocyte antigen class II genes.~     Whole genome association studies suggested more than 50 T1D other susceptibility locus, but~     conferring individually a modest risk to develop T1D. Longitudinal studies demonstrated that~     only a low fraction of genetically predisposed subjects develop T1D and all these genetic~     factors cannot explain the increase in prevalence of T1D in the latter half of the 20th~     century, suggesting the implication of environmental factors.~      Literature has accumulated a lot of evidence for the role of enterovirus in T1D. Several~     retrospective, prospective, post-mortem human studies, as well as animal studies, strongly~     suggest contribution of human enteroviruses to the pathogenesis of T1D. Enterovirus probably~     play a dual role in T1D, some enterovirus being associated with an increased risk of T1D and~     others with a protective effect. Interestingly, several T1D susceptibility loci are~     implicated in antiviral response. Epidemiologic and genetic approaches have led to new~     insights into T1D causation, but a collective explanation is still lacking.~      The project aims at (1) demonstrating the gene-enterovirus interaction effect on T1D onset~     and (2) characterizing the precipitating effect of enterovirus on T1D by a follow-up study~     of T1D high-risk subjects (first degree unaffected relatives with positive autoantibodies to~     islet antigens).~      A structural originality of this project is to perform a family-based study of~     gene-enterovirus interaction in T1D using innovative and robust methods. This project will~     be conducted in close collaboration between our INSERM unit, the Inter-regional network of~     paediatric diabetology, labelled biobanks (CBC Biotec of Hospices Civils de Lyon and CRB-LRB~     of Lariboisière' hospital at Paris), the Centre National de Référence des Enterovirus at~     Lyon and the Centre National de Génotypage at Evry.~      The investigators will first conduct a 3-years pilot study (2016-2019), based on a sample of~     250 nuclear families ascertained through a paediatric T1D proband in four centres. Families~     will be ascertained during the hospitalization of the proband at the time of T1D diagnosis.~     The study will be then extended to whole Inter-regional network of paediatric diabetology.~      This research is a unique opportunity to explore further the implication of enterovirus and~     their interactions with genetic factors involved in T1D susceptibility and aims to target~     high-risk T1D subjects. This innovative project opens the door of the development of~     preventive therapy for T1D.~   "
19335|NCT02804152|"~     Pregnant women using prescription opioid medication (pain medications) are invited to take~     part in a program for the reduction of pain and prescription opioid misuse.~   "
19336|NCT02804139|"~     The purpose of this study is to determine whether a physical therapy program which includes~     scar management, core retraining, and lumbar and pelvic joint mobilization will~     significantly impact the postpartum recovery following Cesarean section during the immediate~     postpartum period and during the first 1.5 years following childbirth.~      All patients who enroll in the study will receive standard treatment following a C-section~     delivery. Subjects will be randomized into one of two groups; one group will receive~     physical therapy in addition to standard post C-section treatment, and the other group will~     receive standard post C-section treatment with no additional physical therapy. Both groups~     will complete questionnaires regarding their pain and recovery from C-section delivery to~     determine if there is a difference in recovery between the group receiving physical therapy~     and the group not receiving physical therapy.~   "
19337|NCT02804126|"~     Comparison of two types of analgesia after cesarean section.~      All patients will anaesthetised with spinal technique. Ultrasound-guided transversus~     abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain~     will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient~     will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).~   "
19338|NCT02804113|"~     The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common~     femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The~     lesion is located within the native CFA and treated with predillation prior to stenting with~     the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6~     and 12 month post procedure. The primary endpoint of the study is the primary patency at 12~     months and periprocedural events up to 30 days post procedure. Secondary endpoints include~     technical success, primary patency rate at 1 & 6 month, freedom from TLR at 1-, 6- and 12~     month follow-up and clinical success at 1-, 6- & 12-month follow-up.~   "
19339|NCT02804100|"~     A multi-centre observational, non-interventional study is to dynamically monitor the changes~     of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.~   "
19340|NCT02804087|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
19423|NCT02803008|"~     To evaluate the Sun protection factor efficacy on human skin.~   "
19424|NCT02802995|"~     The aim of this study is to~        -  To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture~          in treating chronic venous ulcers~        -  To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers~   "
19341|NCT02804074|"~     MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE)~     comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as~     a guide to treatment. Study objectives are to investigate whether a management strategy~     based on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on~     office BP measurements is associated with differences in outcome, including cardiovascular~     and renal intermediate end points at one year; cardiovascular events at 4 years and changes~     in a number of blood pressure-related variables throughout the study. Patients will be~     followed-up during the first year focusing on changes in left ventricular mass index (LVMI,~     co-primary endpoint) and Urinary albumin excretion (UAE, albumin/creatinine ratio,~     co-primary end-point), and during the whole 48 month period for both changes in LVMI and UAE~     and events including all-cause mortality, CV morbidity and mortality, cerebral morbidity and~     mortality.A total of 1240 subjects will be recruited by 30 centers, taking into account a~     dropout rate of 15% (620 subjects per randomization arm).~   "
19342|NCT02804061|"~     Nutrition and exercise behaviour change programs can prevent excessive gestational weight~     gain (EGWG). The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is a~     previously published two-behaviour change program which was successful in preventing EGWG~     across normal weight, overweight and obese pre-pregnancy body mass index (BMI) categories~     (Ruchat et al. 2012; Mottola et al. 2010), however some women found it difficult to adhere~     to two lifestyle behaviour changes throughout pregnancy. The proposed pilot randomized~     controlled trial will address the issue of adherence by identifying the best way to offer a~     two-behaviour change program (NELIP) to pregnant women to increase the effectiveness of~     preventing early and total EGWG. Participants will begin the program at <18 weeks gestation~     and will be randomized to one of three groups: A) Receive both behaviour changes (Nutrition~     AND Exercise) simultaneously at entrance to the study; B) Receive the nutrition component~     first followed sequentially by the introduction of exercise at 25 weeks gestation (Nutrition~     FOLLOWED by Exercise); C) Receive the exercise component first followed sequentially by the~     introduction of the nutrition component at 25 weeks gestation (Exercise FOLLOWED by~     Nutrition).~   "
19343|NCT02804048|"~     Aim: To evaluate the effectiveness of physical therapy intervention techniques in the~     improvement of dyspareunia in climacteric women.~      Study design: This is a randomized controlled trial.~   "
19344|NCT02804035|"~     The proposed pilot study aims to gain experience with the first clinical use of the to-be~     marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to~     assess methods and procedures for evaluation of product performance.~      The objectives of this study are:~        -  To gain first in man experience of a novel drug-device combination product~        -  To evaluate the suitability of the methods and procedures for evaluating of the~          performance of the sc2Wear Pump~   "
19345|NCT02804022|"~     This is a closed-loop system which is embodied in a novel and intelligent algorithm that~     takes into account patients' vital signs. The system allows better and responsive titration~     of personalized pain relief together with non-invasive physiological monitoring that~     measures oxygenation, breathing and heart rate continuously.~   "
19346|NCT02804009|"~     Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to~     determine how anxiety correlates with psychological parameters (personality traits, coping~     strategies and depressive symptoms) and with the outcome of elective coronary angiography~     (CA).~   "
19347|NCT02803996|"~     This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and~     multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that~     was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of~     Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been~     undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a~     Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.~      This study will consist of two parts and the subjects will be assigned to two parts.~      In each part of the study, subjects will be enrolled in the study within 28 days of~     screening.~   "
19348|NCT02803983|"~     The purpose of this study is to compare the early postoperative radiologic and clinical~     outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck~     fracture (Delbet type II and Delbet type III).~   "
19349|NCT02803970|"~     The aim of this study is to collect data on Korean patients with borderline ovarian tumors.~   "
19350|NCT02803957|"~     The objective of this trial is to assess the safety and effectiveness of the study device in~     subjects with degenerative mitral valve disease receiving a mitral valve repair without~     cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve~     repair using standard surgical techniques with cardiopulmonary bypass (control group).~   "
19351|NCT02803944|"~     Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients.~     It was shown that this treatment taken every day or every week for 12 months, can improve~     the respiratory state of patients. From the second year of treatment, it would appear there~     is more profit to continue such treatment.~      The main objective is to study the association between continuous use of azithromycin and~     lung function measured by Forced expiratory volume in one second (FEV1), after two years of~     treatment.~   "
19352|NCT02803931|"~     This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify~     the site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG.~      NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most~     usually caused by atherosclerotic coronary artery disease. It is defined by~     electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or~     positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and~     in an appropriate clinical setting (chest discomfort or angina equivalent). The standard 12~     lead ECG is not commonly sensitive at localising the site of the culprit lesion and even~     coronary angiography may not always be helpful as the majority of lesions will not have~     angiographically evident thrombus. Patients with an ACS may have multivessel disease and it~     is often not possible to identify the precise site of the culprit lesion. In patients with~     multivessel disease, interventionists will frequently target the most severe stenosis even~     though this is not necessarily the acute lesion.~      CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a~     form of 3D vector electrocardiography which can provide quantitative analysis of myocardial~     depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive~     and specific than standard 12-lead ECG at diagnosing stable coronary artery disease.~     Furthermore, recent work has shown CGM to be more sensitive at detecting patients with~     NSTEMI than conventional 12-lead ECG~      In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis~     of both stable CAD and ACS. The hope is this that the clinical application can be extended~     to localising ischaemia in the culprit vessel and be a valuable diagnostic aid.~      The primary objective of this study is to investigate the efficacy of CGM to identify the~     culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate~     the efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared~     to a standard 12-lead ECG~   "
19353|NCT02803918|"~     Primary Objective:~      To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as~     compared to placebo in pediatric patients with T2DM.~      Secondary Objectives:~        -  To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending~          doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric~          patients with T2DM.~        -  To evaluate the change from baseline in fasting and post-prandial plasma glucose~          concentrations during a standardized meal test after 3 ascending repeated doses of~          lixisenatide in comparison to placebo.~   "
19354|NCT02803905|"~     The study is a phase 2, monocentric, open-label study. The investigators will recruit 12~     patients with T1D to be randomly (1:1) assigned to receive islet either into the liver~     through the portal venous circulation (standard procedure; arm A, n=6) or directly into the~     omentum (arm B, n=6). Patients will be selected from those eligible for islet Tx based on~     local practice and guidelines. Immunosuppression will consist of five doses IV infusion of~     rabbit Anti-thymocyte Globulin (ATG, Thymoglobulin®), starting two days prior to the islet~     transplant. Maintenance mycophenolate mofetil (MMF) therapy (1-2 g/day as BID dosing) will~     be started on Day -1 pre-transplant. Tacrolimus will be administered orally twice daily on~     Day 1 post-transplant to maintain a trough level of 10-12 ng/mL for 3 months, then 6-10~     ng/mL thereafter. Etanercept will be given IV before the islet transplant (50 mg), and then~     at 25 mg (subcutaneously) on POD +3, +7 and +10.~   "
19355|NCT02803892|"~     This study is a phase 2, single-center, prospective, randomized, double-blind,~     placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the~     efficacy of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months~     vildagliptin treatment versus placebo in increasing endogenous insulin production and~     correcting glycemic lability. It will involve 60 patients with long standing type 1 diabetes~     (T1D). Patients will receive for one month placebo (Group 1), rapamycin plus placebo (Group~     2), or rapamycin plus Vildagliptin (Group 3). Rapamycin will be administered at an initial~     dose 0.2 mg/kg orally on day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml).~     Vildagliptin will be administered at a dose of 50 mg x2/die starting from day 0. After 4~     weeks of treatment (period A), patients will discontinue rapamycin or relevant placebo~     treatment, but continue Vildagliptin or placebo for a further 8 weeks and be monitored over~     this period (period B).~   "
19356|NCT02803879|"~     Some patients with heart failure require treatment called cardiac-resynchronisation therapy~     (CRT) which involves putting a pacemaker into your heart to make both ventricles (the lower~     chambers of your heart) contract together, making the pumping of the blood to the rest of~     your body more efficient.~      it is important to get the CRT pacemaker checked to make sure that it is working correctly~     and performing its job. However it can be difficult to adjust the settings of the pacemaker~     just the right amount to ensure the heart is pumping efficiently.~      One of the ways this can be done is by using a special machine which uses ultrasound to make~     a 2-dimensional image of the heart called echocardiogram. This technique can also be used to~     measure the flow of blood in your heart and calculate how efficient it is at pumping blood.~     However adjusting the settings of the pacemaker with this device is difficult to use and~     time consuming.~      Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another~     tool used to help adjust the settings of pacemakers, to make the heart pump more~     efficiently. Furthermore, recent research has shown that this is better than echocardiogram~     at optimising pacemaker device settings.~      A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a~     3-dimensional view of the hearts electrical activity and has already been shown to be better~     than normal ECG at diagnosing certain conditions like angina and heart attacks. However it~     has never been used to try optimise the settings of the pacemakers used in CRT and we hope~     it will be a quicker and easier to use than then other methods available. More importantly~     we hope by doing this it will reduce the symptoms that patients suffer as it is making the~     heart pump more efficiently.~      As it has been untested and never used in this setting before, we need to know first if the~     CGM machine will recognise when the settings on the pacemaker are changed.~      The aims of this study is to see if the CGM machine can pick up changes to pacemaker~     settings, with the hope of running a later study to see if it can be used to optimise~     settings on the pacemaker used in CRT.~   "
19357|NCT02803866|"~     In a hospital environment, initial parenting of a family with a preterm neonate will be very~     different than expected. This unusual and stressful situation may determine the~     self-confidence perceived by mothers and fathers in caring their baby and therefore could~     shape future interaction with him/her as well as neurodevelopmental and behavioral~     development of preterm infants.~      24/7 neonatal units allow parents stay with their baby whenever they want but this free~     access nor guarantee neither encourage parenting self-efficacy if it isn`t hand in hand with~     a specific training program for parents.~   "
19358|NCT02803853|"~     The overall objective of the study is to reduce adult obesity in participating American~     Indian (AI) communities and to improve understanding of the behavioral and environmental~     factors affecting obesity in these settings.~   "
19359|NCT02803840|"~     Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are~     treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary~     endpoint of the study is the response rate and Quality of Life of the patients (QoL).~   "
19360|NCT02803827|"~     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have~     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a~     treatable cause for their illness. The investigators will conduct a randomized trial to see~     if rapid testing using novel methods to identify potentially treatable causes of diarrhoea~     leads to improved outcomes. The investigators will also be randomizing children to~     Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of~     care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a~     large multi-centre trial following the previous pilot trial.~   "
19361|NCT02803814|"~     Background: Recently it has been observed in pancreatic cancer that after apparently~     complete surgical resection, histological examination of the surgical specimen according to~     a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of~     patients. To increase the resection margin and reduce such high infiltration rate, a new~     surgical approach based on the initial dissection of the superior mesenteric artery has been~     advocated.~      Aims: To compare the rate of free resection margin (R0) and oncological results of two~     possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the~     pancreas and peripancreatic area: the classic approach versus the initial approach of the~     superior mesenteric artery.~      Methodology: Prospective, randomized, multicenter study in which patients with pancreatic~     and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical~     approach from the superior mesenteric vein will be performed and in the other group an~     initially dissecting the superior mesenteric artery approach will be carried out. 116~     patients are required and the main variables considered are: free margin rates (R0) or~     infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic~     recurrence, disease-free interval and survival at 1, 3 and 5 years.~   "
19362|NCT02803801|"~     This pilot project is a cooperative effort between the Leisure in Fun Environments (LIFE)~     Program and the Specialized Communication Resources for Children (SCRC) Program at the~     Rehabilitation Centre for Children (RCC). The investigators will blend and enhance two~     pre-existing programs in order to provide a new, specialized program for parents of children~     with ASD or developmental delay. The two programs that will be blended together are~     Promoting Flexible Thinking and Interaction with Your Child at Home and Saturday Cooking~     Club. This new program will be a series of ten workshops that alternates between parents~     only learning sessions and practical cooking club sessions that allow parents to focus on~     practicing what they are learning with their child. These programs are based on the~     principles of Relationship Development Intervention (RDI®), which focuses on providing~     opportunities to establish a guided participation relationship, which will lead to~     development of dynamic intelligence and important social thinking abilities. The program is~     individualized to each child and builds on the principles of typical development to assist~     the child in achieving social competence. Using this program, children are expected to~     develop sociability in a naturally progressing order of complexity.~   "
19363|NCT02803788|"~     -  To study the efficacy and side effects of ondansetron with dexamethasone in patients~          undergoing standard laparoscopic cholecystectomy (control group).~        -  To study the efficacy and side effects of ramosetron in patients undergoing standard~          laparoscopic cholecystectomy (study group).~        -  To compare the efficacy and side effects of ondansetron with dexamethasone and~          ramosetron in patients undergoing standard laparoscopic cholecystectomy~   "
19364|NCT02803775|"~     Cardiac resynchronization therapy (CRT) is a well established clinical therapy for patients~     with symptomatic left ventricular systolic dysfunction and electrocardiographic QRS duration~     of 120 ms or greater. Multicenter trials have consistently demonstrated CRT non responder~     rates of 32-43% at 6 months. Subsequent studies have shown that utilizing~     echocardiographic-guided device reprogramming for optimal atrio-ventricular (A-V) and~     interventricular (VV) delays at rest have improved clinical response. Recently, an~     echocardiographically validated automated pacemaker programmer-based intra-cardiac~     electrogram (IEGM) algorithm has been developed for rapid optimization of sino-ventricular~     (P-V), A-V and V-V delays at resting heart rates that is partially based on the~     interventricular conduction time delays. Nevertheless, controversy still persists as to the~     applicability of both echocardiographic and IEGM derived algorithms at elevated heart rates,~     as with physical activity, when patients are more likely to experience symptoms related to~     poor cardiac output.~      Recent studies have shown clinical benefits of pacing from sites of late intrinsic~     activation or intra-ventricular conduction delays (IVCD). Some studies have utilized the~     intrinsic SENSED IVCD method while others used the right ventricle (RV)-PACED IVCD. There~     have not been any studies to date that compare both methods to determine if one may yield a~     better clinical outcome with lower non-responder rates.~      This study predicts that the RV paced IVCD method will provide better clinical outcomes than~     the longest RV sensed IVCD as determined by the clinical composite score.~      The study is a prospective double blind study with an additional cross-over group consisting~     only of non-responders to compare the clinical response in 72 patients receiving CRT~     therapy. After successful CRT-D implantation and before hospital discharge patients will be~     randomly assigned in a 1:1 fashion to Group 1 (SENSED) or Group 2 (PACED). The patient will~     complete a Minnesota Living with Heart Failure questionnaire, compare echocardiographic data~     and be assessed by a blinded nurse and physician prior to discharge and at each follow up~     visit to maintain the double blind design.~      After 3 months of follow-up, non-responders from each group will be crossed-over to the~     other group and followed for an additional 3 months. Clinical data will be collected at the~     end of that 3 months and compared looking at changes in symptoms, ejection fraction (EF) and~     other echocardiographic measurements, New York Heart Assocation Function Class ( NYHA)~     class, clinical composite scores (CCC), device interrogation data and hospital admissions~     between the two groups to see if there is a statistical difference.~   "
19365|NCT02803762|"~     This study is an open-label, absorption, metabolism, excretion, and mass balance study of~     400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single~     dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on~     Day 1.~   "
19366|NCT02803749|"~     Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life~     yet it frequently remains untreated and there have been no clinical trials dedicated to~     evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is~     effective for the treatment of generalized anxiety disorder in the general and elderly~     population. It is not known if it is effective for the treatment of anxiety in Parkinson's~     disease. This is a single-center, placebo-controlled, double-blind design with participants~     randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg~     twice daily) or placebo for 12 weeks.~   "
19367|NCT02803736|"~     This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture~     on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in~     two groups: the real acupuncture group and the sham acupuncture group.~   "
19368|NCT02803723|"~     Holding-cuddling plus oral sucrose versus oral sucrose for reducing venipuncture pain in~     newborns and infants.~      Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care~     units.~      Such procedure is painful and several units administer 24% oral sucrose with pacifier during~     venipuncture, as this non-pharmacological intervention is considered safe and effective for~     procedural pain relief in infants from birth to 3 months of age. However, several studies~     point out that further research is needed to assess its efficacy in combination with other~     behavioral interventions for analgesia during painful procedures. Current knowledge suggests~     that multisensorial stimulation associated with oral sucrose could allow even more effective~     analgesia. To date, the studied stimulation strategies are based on massage, voice, eye~     contact and fragrance during heel prick. The holding-cuddling - that is the fact of~     holding the child in a safe, reassuring and warm position during the examination or medical~     intervention is promoted by various hospitals in order to favor the comfort of all the~     caregivers during such a procedures. This intervention should be primarily parents-driven~     but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of~     this study is that the combination of holding-cuddling plus oral sucrose in more effective~     than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns~     or infants less than three-month-old.~   "
19369|NCT02803710|"~     Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced~     by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass~     by these enzymes which makes the molecules of last resort in serious infection. Recently the~     prevalence of enzymes hydrolysing carbapenem, the carbapenemases, was increasing in some~     countries. But these carbapenemases are not the only mechanism involved in a decreased~     susceptibility to carbapenems which is sometimes linked to the conjunction of several~     resistance mechanisms. Data available on the epidemic situation of this new resistance are~     essential for improving their detection, the management of infections in patients and~     prevent the occurrence of epidemic. In this context, the investigators propose a study in~     the North-East inter-region to estimate the prevalence of Enterobacteriaceae with decrease~     susceptibility to carbapenems and look for risk factors for infection with this type of~     bacteria. The study is conducted in five teaching hospitals (Besançon, Dijon, Nancy, Reims~     and Strasbourg) and two general hospitals (Colmar and Troyes) in North-Eastern France. For~     one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems~     (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM)~     (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the~     Reims University Hospital. Among these strains 105 are randomly selected. The clinical study~     is conducted as follow: for each patient with CDSE isolate included in a center, 2 control~     patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with~     no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.~      Microbiological study : identification of isolates is performed using MALDI-TOF (Bruker~     Daltonics, Bremen, Germany). Antibiotic susceptibilities is determined by the disc diffusion~     method according to European Committee on Antimicrobial Susceptibility Testing (EUCAST)~     guidelines (www.EUCAST.org) and extended-spectrum beta-lactamase (ESBLs) are detected by the~     double-disc synergy test and carbapenem minimal inhibitory concentrations (MICs to Imipenem,~     Ertapenem, Doripenem and Meropenem) determined using E-test® strips. Metallo-β-lactamase~     production was screened with the MβL Etest (bioMérieux, Marcy l'Etoile, France).~     Beta-lactamases detected using polymerase chain reaction (PCR). Carbapenemase-encoding genes~     (blaKPC, blaVIM, blaIMP, blaNDM, blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and~     blaOXA-48-like) were screened using multiplex PCRs and blaIMI and blaGES with simplex PCRs.~     All the blaOXA-48-like detected were subsequently sequenced. Genes blaTEM, blaSHV, blaCTX-M~     and blaOXA were detected by PCR using specific primers. Plasmid-mediated AmpC-type genes~     blaACC, blaFOX, blaMOX, blaDHA, blaCMY and blaMIR were screened using multiplex PCRs. All~     the beta-lactamases are sequenced. Mutations in the quinolone resistance determining region~     (QRDR) are identified by PCR and sequencing in the gyrA, gyrB, parC and parE genes. Qnr and~     qepA genes are detected by real-time PCR, aac(6')-Ib-cr by pyrosequencing and oqxAB by~     conventional PCR. Genotyping is performed with pulsed-field gel electrophoresis (PFGE) and~     multilocus sequence typing (MLST).~      Statistical analysis : qualitative variables are analysed with the Chi2 test and the~     two-tailed Fisher exact test. Quantitative variables are compared using the Mann-Whitney~     test. Then, a multivariate analysis is conducted: logistic regression with stepwise factors~     as explanatory variables with p <0.20 in the univariate analysis as input threshold and~     output set at 0.20.The results are considered statistically significant when P < 0.05.~      Expected results : this study will give the proportion of the different species involved, of~     the carbapenemase in comparison to the other mechanisms, the level of resistance in MIC.~     Risk factors such as previous antibiotic treatment, underlying disease severity or clonal~     strain transmission will be evidenced, allowing to identify prevention control measure to~     implement.~   "
19370|NCT02803697|"~     Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their~     growth is usually slow and diagnosis is often made in the context of masse effect .The~     therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic~     radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an~     individualized follow-up and recurrence could happen 10 or 15 years after the first surgery.~     In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to~     find predictive factors of recurrence to personalized the follow-up of each patient.~   "
19371|NCT02803684|"~     While renal graft outcomes were really improved for the last decade, long time outcomes~     remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate~     reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other~     features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte~     antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal~     graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect~     precociously renal injuries at a reversible stage before clinical manifestation. However,~     renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a~     non-invasive diagnostic tool allowing the early detection of renal injuries, especially~     allograft rejection without hemorrhagic risk. This tool could be applied routinely to the~     renal allograft recipient in replacement of protocol biopsies.~      Here, aim of this study is to correlate the results from diffusion MRI of renal graft with~     pathologic findings from protocol renal graft biopsies.~      In this view, the investigators include prospectively all recipients of renal~     transplantation who beneficiate of a protocol renal graft biopsy without barrier to peform~     MRI examination. Thus, the investigators exclude patients who are not be able to beneficiate~     of a MRI examination and patient obstacle to renal graft biopsy.~      Expected results are the Banff classification from the histopathologic analysis of biopsies.~     The expected results for MRI examination are signal intensity, diffusive coefficient,~     anisotropy fraction and change of the diffusion way. Next, the investigators search an~     association between these features by statistical analysis (Wilcoxon test, Chi², Fisher,~     Pearson or Spearman).~      The investigators performed this study since 01/06/2014 and projected end-time to~     01/06/2017.~   "
19372|NCT02803671|"~     This project corresponds to the main field of research of the investigators's laboratory~     concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In~     this context, the investigators have developed know-how and specific acquisition and~     analysis tools (2 patents and several publications), allowing them to apply this know-how in~     children with patent ductus arteriosus.~      Patent ductus arteriosus after birth is characterized by shunting of a variable proportion~     of cardiac output towards the pulmonary circulation. The direct consequences of this~     shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing~     the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory~     complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary~     circulation, other systemic organs are deprived of part of their normal perfusion and are~     subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and~     electrical dysfunction, the analysis of which constitutes one of the objectives of this~     project.~   "
19373|NCT02803658|"~     About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of~     cases, a male component is identified, but is not always sufficient to explain infertility.~     In the majority of cases, the cause cannot be clearly identified and multiple abnormalities~     may be detected in both partners.~      Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution,~     exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These~     factors may also impact on the fertility of the children conceived, which is described as an~     intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).~      Few scientific studies with a high level of proof have been published on the impact of~     smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be~     altered by these environmental factors, which may trigger a process of apoptosis or~     alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA~     methylation and histone acetylation, which control gene expression and are grouped under the~     term epigenetic modifications. More recently, oestrogens has been shown to be involved in~     male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal~     maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in~     ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in~     spermatozoa. The study of transcript profiles could provide information about the quality of~     spermatogenesis and/or spermiogenesis and during the first steps of embryonic development.~     Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be~     used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low~     concentrations of xenobiotic oestrogens can exert biological effects on certain functions of~     murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These~     factors are all the more effective when they act in combination, as human gametes appear to~     be more sensitive to their action than murine gametes All studies conducted to date have~     investigated the impact of toxins either on one of the partners or in the children born to~     the couple. No detailed and high-level scientific study has studied both partners and the~     quality of their embryos.~   "
19374|NCT02803645|"~     Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies,~     predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA).~     Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous~     and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary~     to an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in~     the context of APS, APL can also be observed in various clinical situations and in healthy~     subjects. Published studies have reported a variable prevalence of APL in healthy subjects,~     essentially ACL and/or LA, and their clinical significance currently remains unclear.~      Several studies have highlighted the link between APL and atherosclerosis. It therefore~     appears interesting to more specifically study the association between the presence of APL~     and the presence of cardiovascular risk factors in a population of healthy subjects.~     Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a~     complex interaction between atherogenic plasma factors and cells of the arterial wall.~     Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid~     peroxidation also plays a major role during the atherogenesis process. It will therefore~     also be important to correlate APL with markers of vascular inflammation and markers of~     oxidative stress.~      A prospective case-control study will therefore be conducted on 1,500 healthy blood donors.~     Subjects screened APL-positive will be compared to APL-negative subjects in terms of~     cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular~     disease will not be studied). In the context of a blood donation, all subjects wishing to~     participate in this study will attend a medical interview and a clinical examination during~     which various data will be collected, mainly the presence of cardiovascular risk factors. A~     blood sample will also be taken to assay the various laboratory markers studied.~      This study should provide a better understanding of the role of APL in healthy subjects and~     more clearly specify their possible link with atherosclerosis in this population.~   "
19375|NCT02803632|"~     An excess suicide-related morbidity is observed among young people in the Picardie region,~     as reflected by the > 100% occupation rate of the Amiens University Hospital Adolescent~     Medicine Unit. New approaches have been proposed to these problems that have led us to~     reorganize our diagnostic practices: 1) more precise characterization of suicidal behaviour~     by using standardized instruments such as the French version of the Columbia-Suicide~     Severity Rating Scale developed by Posner (C-SSRS); 2) new clinical entities, such as~     disruptive mood dysregulation disorder, are now proposed in international classifications~     (DSM 5 field trial); 3) investigations such as recording of the circadian rhythm of motor~     activity by actigraphy are being studied as a laboratory complement to psychiatric~     diagnosis.~   "
19376|NCT02803619|"~     Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced~     Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT)~     chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced~     NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal~     growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in~     selected NSCLC patients in some retrospective research. Our single-center prospective~     research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM~     patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A~     multi-center prospective observational biomarker study will be started in 11 lung cancer~     center based on our single-center prospective research result. The aims of the study are to~     find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based~     comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical~     assessment criteria for NSCLC-LM EGFR-TKIs treatment.~   "
19377|NCT02803606|"~     Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal~     Medicine unit will be included after informing the parents. Abdominal skin and peripheral~     (arm or leg) and incubator air temperatures and relative humidity will be obtained from data~     recorded by the incubator without using any additional transducer compared to standard care.~     Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization~     will also be recorded from routine monitoring. A case report form and a wide-angle video~     recording of the infant's room will allow description of the type of care, determine the~     duration of care and the impact on incubator function. Data will be recorded for the first 7~     days of life of the preterm neonate.~   "
19378|NCT02803593|"~     The purpose of the proposed randomized intervention study is to test the efficacy of the~     technology-based information and coaching/support program for Asian American breast cancer~     survivors (TICAA) in enhancing the women's breast cancer survivorship experience at three~     time points (pre-test, post1-month, and post 3-month).~   "
19379|NCT02803580|"~     The purpose of the present study is to evaluate the characteristics, management and clinical~     course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in~     terms of symptoms, lung function and exercise tolerance during 12 months of observation.~   "
19380|NCT02803567|"~     The primary goal of this project is to develop a tailored screening, brief intervention and~     referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for~     delivery at point of care during a routine healthcare visit, through conducting a rigorous~     randomized control trial among adolescent patients with type 1 diabetes (TID) or~     rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of~     parents of these same adolescents, to explore links between parent beliefs and adolescent~     behavior around substance use.~   "
19381|NCT02803554|"~     The purpose of the study is to evaluate the beneficial effects of infusions of plasma from~     young donors using blood biomarkers.~   "
19382|NCT02803541|"~     Purpose: Most children and adolescents with chronic kidney disease (CKD) have much less~     physical endurance than their age matched peers, are at high risk for premature~     cardiovascular disease, and have a poor self image in part due to limited peer contact.~     Sustained exercise in adults with CKD improves endurance and decreases cardiovascular risk.~     Minimal data exists in pediatric CKD patients. This study will show whether 12 days of~     increased exercise at a summer camp will improve endurance as measured by the distance~     walked in 6 minutes and self concept as measured by a short standardized questionaire~     (Harter scale).~      The study will occur at the Frost Valley YMCA in the Catskills where in 2, 12 day sessions a~     total of 25-30 kidney campers are mainstreamed in the general camp population of about 500.~      Mainstreaming means that the kidney camper will live in a cabin with 8-10 age matched peers~     and participate as much as possible in all camp activities with their bunkmates. The kidney~     program at Frost Valley provides hemo and peritoneal dialysis, as well as caring for~     children with less advanced CKD and post transplant.~      Participants will have activity measured before and duringcamp by wearing a pedometer. The~     distance walked in 6 minutes (a 6 minutewalk test) will be measured at onset and completion~     of the 12 day camp experience. A standardized questionaire on self concept will also be~     administered at the onset and completion of camp.~   "
19383|NCT02803528|"~     Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.~   "
19384|NCT02803515|"~     Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It~     corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal~     treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic~     lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly~     improved survival rate in patients with ovarian PC and decreased recurrence and mortality~     rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia~     (43°). However, the cellular mechanisms involved are not fully understood, but they include~     cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on~     pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and~     exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of~     this study are to validate these findings in tissue samples of patients with ovarian PC. We~     will constitute a bank of isolated tumor samples before and after HIPEC and measure~     postoperative HSP90 serum levels in order to establish if they are predictive of a response.~     HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four~     patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden~     therapeutic possibilities including the use of new immunotherapy. The multimodal approach~     could improve the efficacy of HIPEC with a minimal systemic toxicity.~   "
19385|NCT02803502|"~     In the context of hemophilia, it is well know that the level of factor VIII alone does not~     reflect the clinical phenotype of the patients in an accurate way. At equal factor VIII~     levels, certain patients will bleed more than others.~      The thrombin generation test (TGT) is a test that seems to provide a better prediction of~     the overall hemostatic status of an individual patient. In a previous study, the~     investigators have established normal reference values of the thrombin generation curve in~     children aged 6 months to 16 years and adults. The goal was to evaluate the use of this test~     in different clinical contexts and in severe hemophilia patients in particular. A pilot~     study showed that the patients having a thrombin generation <150 had a severe phenotype,~     whether those who received an appropriate prophylaxy had a thrombin generation superior to~     150.~      Moreover, the investigators now have access to a software tool that allows them to~     individually determine the pharmacokinetic profile of the factor VIII injected to each~     patient. The factor VIII concentration is measured at injection and 30 minutes, 1 hour, 2~     hours and 24 hours afterwards. The introduction of these concentrations in the software~     allows to obtain the half-life of factor for a given patient, the maximum peak, and the~     minimum factor level (though level). The injected dosis might be sufficient (disappearance~     of substantial diminution of the bleedings) or unsufficient (persisting bleeding) for a~     given patient.~      This study aims:~        -  to measure the pharmacokinetic profile of factor VIII by two different methods, the~          time-based method and the chromogenic method~        -  to correlate the results with the TGT results obtained at the same time points and~          determine which method gives the best correlation~        -  to link the clinical symptomatology (improved symptomatology or not) with the TGT~          results~        -  to determine which minimal TGT result is linked to a minimal bleeding rate~        -  to adapt the prophylactic dosis of the patient in a personalized way.~   "
19386|NCT02803489|"~     Prospective, non-randomized, open-label, pilot study conducted in a single group of 30~     evaluable patients, i.e. patients completing an approximate 3 month follow-up.~   "
19387|NCT02803476|"~     The primary aim of the current study is to clarify whether serum vitamin D levels [25(OH)D3]~     have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women~     versus healthy ones.~      To achieve this aim, the investigators will conduct a prospective observational study~     involving obese and lean PCOS women in comparison to obese and lean healthy subjects living~     in Cairo, Egypt.~   "
19391|NCT02803424|"~     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an adverse effects on respiratory mechanics and gas exchange.~     Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak~     pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled~     ventilation improves gas exchange and respiratory mechanics in patients undergoing~     robot-assisted laparoscopic radical prostatectomy.~   "
19392|NCT02803411|"~     To describe the natural history of the coronary atherosclerotic plaque development and~     progression in mild to moderate CAD over time by CCTA with demographic and laboratory data~     for refinement of risk stratification of patients referred for CCTA.~   "
19393|NCT02803398|"~     The aim of the study is to measure and model interface pressure applied on the lower leg of~     patients at risk of veinous thrombosis, by different bandage combinations, composed of~     Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should~     better predict the interface pressure distribution than Laplace's Law.~   "
19394|NCT02803385|"~     This study aims to compare the efficacy of pain control, the consumption of local anesthetic~     and opioids, side effects, and patient satisfaction between continuous epidural infusion and~     patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.~   "
19395|NCT02803372|"~     The purpose of this study is to investigate whether circulatory management based on~     LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in~     patients undergoing partial nephrectomy when compared with routine circulatory management~     based on blood pressure and urine output monitoring~   "
19396|NCT02803359|"~     The primary purpose of this study will be to determine whether the proposed study protocol~     will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR).~     Laryngeal evoked brain stem responses will be recorded from five test subjects under general~     anesthesia in the operating room with the assistance of an electrophysiologist with~     expertise in evoked potentials. Once the feasibility of obtaining tracings are established~     on the first few subjects, responses will be recorded from other test subjects with the aim~     of determining the optimal placement of stimulating electrodes and detection leads necessary~     to elicit an adequate response. The effect of varying the stimulus intensity will also be~     studied. Once parameters for testing have been standardized, normative configurations for~     the laryngeal evoked brainstem response tracings can be determined by patients both in the~     office setting and in the operating room.~   "
19397|NCT02803346|"~     Septic syndromes (systemic inflammatory response associated with infection) remain a major~     although largely under-recognized health care problem and represent the first cause of~     mortality in intensive care units. While it has long been known that sepsis deeply perturbs~     immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings~     indicate that sepsis indeed initiates a more complex immunologic response that varies over~     time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a~     resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted~     immunosuppression. This is illustrated in those patients by reactivation of dormant viruses~     (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic~     solely in immunocompromised hosts. These alterations might be directly responsible for~     worsening outcome in patients who survived initial resuscitation as nearly all immune~     functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed~     markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and~     deactivated monocyte functions). New promising therapeutic avenues are currently emerging~     from those recent findings such as adjunctive immunostimulation for the most~     immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg,~     GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who~     could benefit from it, as there is no clinical sign of immune dysfunctions. The main~     objectives are:~        1. to identify the best biomarkers for sepsis-induced immunosuppression and~        2. to evaluate ex vivo whether drugs could rejuvenate immune functions.~   "
19398|NCT02803333|"~     The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are~     working together to better understand the patient's entire lung cancer experience, both~     inside and outside the doctor's office. By combining the data that is captured by their care~     team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the~     investigators hope to improve patient-physician treatment decisions, so that the patient's~     personal treatment goals and quality of life have the highest chances of being fulfilled.~   "
19399|NCT02803320|"~     The objective of this study was to assess the safety and appropriateness of a sunscreen~     product for use on sport users, under supervised outdoor use conditions.~   "
19400|NCT02803307|"~     This trial is a multi-site, randomized, open-label, parallel, and single-dose administration~     study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of~     the knee.~   "
19401|NCT02803294|"~     The purpose of this study is to evaluate the safety and effectiveness of transcatheter~     aortic valve replacement in Chinese population.~   "
19402|NCT02803281|"~     Determine the feasibility of assessment of measures of frailty and determine if these~     measures provide a clinically important contribution of risk assessment in a population of~     patients undergoing major thoracic surgery for lung or esophageal cancer.~   "
19403|NCT02803268|"~     A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of~     MT-8554 in Female Subjects Experiencing Vasomotor Symptoms~   "
19404|NCT02803255|"~     The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that~     follows the assist-as needed paradigm provide statistically significant improvements in~     arm and hand motor functions when compared to robot-aided protocols that passively move~     patients' arms along pre-defined trajectories, in patients with incomplete spinal cord~     injury (SCI).~   "
19405|NCT02803242|"~     The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with~     the goal of enrolling 75,000 or more COPD patients and those at risk who are willing to~     share their heath information over several years and participate in research. The COPD PPRN~     has built an online platform to allow volunteers to enroll electronically, complete surveys,~     be contacted about studies they qualify for and become connected to COPD resources. The goal~     of the registry is to speed research to find better treatments for COPD and ultimately a~     cure.~   "
19406|NCT02803229|"~     The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety~     and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the~     treatment of individuals with Cannabis Use Disorder (CUD) and~     Attention-deficit/Hyperactivity Disorder (ADHD). The investigators plan to enroll 50 and~     randomize 40 of these patients in the trial. The primary objective of the study is to~     determine the efficacy of MAS-XR in promoting cannabis abstinence among individuals with CUD~     and in promoting a decrease of ADHD symptoms.~   "
19407|NCT02803216|"~     To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and~     powder combined with standard triple therapy on improving eradication rate of Helicobacter~     Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in~     the trial.~   "
19408|NCT02803203|"~     The purpose of this study is to test the safety of combining the drugs osimertinib and~     bevacizumab at different dose levels. The investigators want to find out what effects, good~     and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This~     study will try to find the best dose of osimertinib and bevacizumab given together that does~     not cause significant side effects. Once the investigators determine that combining~     osimertinib and bevacizumab is safe, they want to see if the combination is effective in~     treating lung cancers with the EGFR mutation.~   "
19409|NCT02803190|"~     The investigators' previous studies in 2014 and 2015 have demonstrated that among~     community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia~     indices can be improved and bone mineral density (BMD) maintained with different exercise~     programs. In 2016, the investigators aim to determine the effects of 2 exercise~     interventions on posture corrections and further improvement of sarcopenic indices~   "
19410|NCT02803177|"~     In the present phase-II clinical trial the researchers investigate efficacy and proof of~     concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto~     ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of~     proximal humeral fractures.~   "
19411|NCT02803164|"~     Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds~     (OCW) and will decrease the time-to-closure of such wounds when compared to a historical~     cohort of patients managed by traditional wound care management.~   "
19412|NCT02803151|"~     Lymph node metastasis is one of the most common sites to develop disease recurrence or~     progression after initial local treatment for primary solid malignancies or systemic~     treatment for advanced metastases. No specific treatment modality has been established as~     the standard therapy. Systemic therapy is usually considered since lymphadenopathy is~     considered as a sign of disease dissemination though aggressive local treatment, including~     surgical lymphoadenectomy or radical radiotherapy might result in long-term survival in~     selected patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of~     radiation targeted to a pathological entity and delivered in a few fractions, has proven so~     successful at treating both benign and malignant lesions that it changed the paradigm for~     radiation therapy. The radiobiology of SABR has been shown to be very favorable for tumor~     control. Clinical experiences suggested that SABR might offer excellent in-field tumor~     control with low toxicity profile in selected patients, although the majority of reports are~     retrospective and include small patients series with heterogeneous tumor sites and~     dose-fractionation schedules.~      At present, there is lack of validated prognostic factors to identify the patients who might~     benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of~     effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on~     clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the~     present study is aimed to provide a better understanding about utilization of SABR for~     metastatic lymph node(s). The associated translational researches will also advance our~     knowledge in the immune system reactions to SABR.~   "
19413|NCT02803138|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
19414|NCT02803125|"~     The purpose of this project is to develop an intervention to improve psychosocial~     functioning and quality of life for older Veterans with partial or full PTSD.~   "
19415|NCT02803112|"~     The investigators aim to retrospectively map the delays in the acute care of traumatic brain~     injury patients necessitating emergent craniotomies.~   "
19416|NCT02803099|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19417|NCT02803086|"~     The prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy~     (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of~     microscopic lymph-nodal metastases. Nevertheless, even though delivered by means of modern~     Intensity-Modulated Radiotherapy (IMRT) techniques, WPRT may result in intestinal,~     hematologic and urinary toxicity (IT, HT, UT, respectively) severely affecting patients'~     daily health-related quality-of-life (HRQoL) within the so-called and inadequately~     investigated Pelvic Radiation Disease.~      The aim of this study is to develop sophisticated predictive models of IMRT-WPRT induced~     patient-reported HT, IT and UT in PCa. The possible correlation between several clinical~     factors and radiation doses received by various pelvic structures (i.e. pelvic bones~     subvolumes, intestinal loops, sigmoid, rectum and bladder) and risk and severity of~     patient-reported IT, UT and HT will be analyzed and robust multi-variable models will be~     developed and internally validated. A secondary end-point will be the identification of~     specific symptoms affecting patients' HRQoL during irradiation and in the long term, overall~     and in different therapeutic settings (radical, adjuvant and salvage). Lastly, possible~     correlation between HT and UT/IT will be investigated.~   "
19418|NCT02803073|"~     The purpose of this study is to determine the effects of testosterone replacement in~     hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial~     infarction.~   "
19419|NCT02803060|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19420|NCT02803047|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19421|NCT02803034|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19425|NCT02802982|"~     Parents of infants who have been thrombocytopenic for 3-4 days will be approached for~     consent to enter the study. For the purposes of the study, thrombocytopenia will be defined~     as a platelet count <60,000/uL or a platelet count <100,000/uL that prompted a platelet~     transfusion. Following enrollment, the platelet count will be followed in each infant.~     Participants will enter the study if on day 5 or later after the onset of thrombocytopenia~     (defined as above) infants either have a platelet count <60,000/uL or a platelet count~     <100,000/uL for which a platelet transfusion is ordered.~   "
19426|NCT02802969|"~     Improved local control of chordoma initially treated with surgery or not, thanks to adjuvant~     radiotherapy oriented by conventional imaging Computed Tomography /Magnetic Resonance~     Imaging (CT / MRI) and guided by the [18Fluor] ([18F]) Fluoroazomycin Arabinofuranoside~     (FAZA) Positron Emission Tomography / Computed Tomography (PET / CT) to target the~     radioresistant hypoxic cells.~   "
19427|NCT02802956|"~     Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke~   "
19428|NCT02802943|"~     The aim of this study is to induce a peptide-specific immune response in chronic lymphatic~     leukaemia (CLL) patients by multi-peptide vaccination with a patient-individualized peptide~     cocktail and, dependent on minimal residual disease (MRD) status, the immunomodulatory drug~     lenalidomide.~   "
19429|NCT02802930|"~     The primary objective of this study was to evaluate the potential for phototoxicity of the~     sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a~     negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test~     materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).~      The secondary objective of this study was to evaluate the safety of the sun care products~     SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by~     monitoring adverse events (AEs) throughout the study.~   "
19430|NCT02802917|"~     The primary objective of this study was to compare the human eye stinging potential of~     experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50~     X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.~   "
19431|NCT02802904|"~     Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol~     backbone to which 3 esterified fatty acids are attached. The positions of fatty acid~     attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing~     evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position~     with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3~     positions of fat molecules do not raise serum cholesterol levels. These observations have~     come to be known as or explained by the sn-2 hypothesis. New evidence have also emerged to~     show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat~     deposition in a rat model. In this proposed study, the effects on the outcome measures~     investigated of three test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and~     cocoa butter (POS)], with oleic acid primarily at the sn-2 position but differing amounts of~     palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule,~     are investigated~   "
19432|NCT02802891|"~     The JOIN project combines the health and indoor environment research areas to contribute in~     the development and validation of a new asthma diagnosis method through exhaled VOC~     analysis. This method is more sensitive, more specific, and completely non-invasive.~     Moreover, the JOIN project will assess the impact of exposure to the indoor environment,~     namely endocrine disruptors, on asthma and allergy development in children.~   "
19433|NCT02802878|"~     The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular~     electrical stimulation with volitional contraction (NMES-VC) training program to improve~     quadriceps strength and activation, while not adversely affecting knee-related pain,~     activities of daily living or quality of life in women with knee pain. The primary outcome~     will be change in maximal isokinetic knee extensor torque.~      The investigators will test the following hypotheses. In comparison with low-load (40%)~     resistance training without electrical stimulation, a 12-week NMES-VC training program will:~      Hypothesis 1: Increase maximal isokinetic knee extensor torque~      Hypothesis 2: Increase rate of muscle force development~      Secondary questions and response variables~      Hypothesis 3: Not adversely affect knee pain or quality of life, assessed by the Knee injury~     and Osteoarthritis Outcome Score (KOOS) questionnaire~      Additional hypotheses in women with risk factors for incident symptomatic or progressive~     KOA:~        1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training~          increases quadriceps muscle rate of force development~        2. Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated~          (using numeric rating scale survey level of pain you experienced during the hybrid~          training or 40% isokinetic exercise)~        3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training~          increases physical function (20m walk, chair stand, stair climb times, KOOS)~        4. Determine the extent to which NMES-VC enhanced low-intensity resistance training~          increases pressure pain threshold~   "
19434|NCT02802865|"~     This study evaluates the addition of clomid to letrozole for the treatment of infertility in~     women with polycystic ovary syndrome. Half of the participants will receive letrozole and~     clomid in combination, while the other half will receive letrozole alone.~   "
19446|NCT02802709|"~     This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.~     Half of the patients will receive the agent via intra-articular injection and half will~     receive a placebo injection.~   "
19447|NCT02802696|"~     This is a pilot double-blinded placebo-controlled randomized controlled trial (RCT) to~     evaluate the feasibility of conducting a multicenter, randomized, placebo-controlled trial~     to assess the efficacy of pre-transfusion furosemide in preventing transfusion-associated~     circulatory overload (TACO) in hemodynamically stable inpatients aged 65 years or older~     receiving a single unit red blood cell transfusion. Patients will be randomly allocated to~     receive either furosemide (20mg intravenous) or placebo (saline) within 60 minutes of~     starting a red blood cell (RBC) transfusion. Randomization will be stratified by centre and~     renal dysfunction (creatinine clearance ≥ 60 mL/min or < 60 mL/min). This is a blinded~     trial: patients, care-providers (physicians and nurses), data collectors, outcome~     adjudicators, and data analysts will not be aware of group allocation.~   "
19435|NCT02802852|"~     Neovascularization (NV) is the innate capability to enlarge collateral arteries~     (arteriogenesis), and to stimulate growth of new capillaries, arterioles and venules at~     the tissue level (angiogenesis). Patients with Chronic Limb-threatening Ischemia (CLI)~     present with forefoot rest-pain, ulceration and/or gangrene. They require risky and costly~     revascularization operations to avoid amputation. The investigators hypothesize that their~     inadequate NV can be modulated to restore this capability. By correcting impediments to NV~     in an out-patient setting, the investigators expect to facilitate CLI management.~      While the following impediments to NV are complex, the solution is not. Arteriogenesis~     necessitates endothelial cell activation in small collaterals as blood is offloaded away~     from the occluded artery. Shear stress provides this stimulus, but is attenuated caudal to~     multi-level arterial occlusive disease. The arteriogenesis switch is not turned on.~     Furthermore, the lack of nutritive oxygenated blood inflow and the accumulation of toxic~     metabolic by-products are adverse to synthetic pathways in the ischemic tissue.~     Additionally, protein distress signals cannot be effectively disseminated by the ischemic~     tissue, and the reparative progenitor cells they are supposed to mobilize cannot effectively~     home back to the ischemic tissue to orchestrate NV. The CLI patient is especially~     disadvantaged by having diminished function and number of circulating progenitor cells~     (CPC). Lastly these elderly, often diabetic, patients are less able to fend off infection.~      An FDA approved external programmed pneumatic compression device (PPCD) was used to restore~     the shear stress stimulus required for arteriogenesis. It also enhances oxygenated nutritive~     arterial inflow, clears waste products of metabolism (increased venous and lymphatic~     outflow), and helps distress proteins reach the central circulation and mobilized progenitor~     cells to return to the ischemic tissue. We corrected the progenitor cell and immunologic~     impairment with granulocyte colony stimulating factor (G-CSF), FDA approved for stem cell~     mobilization and immunological boost in the setting of cancer chemotherapy. The preliminary~     data show clinical, angiographic, hemodynamic and biochemical evidence for enhanced NV. The~     purpose for this study is to enroll 25 patients to reproduce the biochemical data to support~     a large scale clinical trial.~   "
19436|NCT02802839|"~     Children with Cystic fibrosis (CF) have to undergo several needle-related procedures during~     outpatient visits or hospital stay. It is common for children with CF to display distress~     and behavioural problems during invasive procedures. Children with chronic diseases have a~     lower threshold of pain compared to non-chronic patients. Effective management of needle~     distress in children with CF is critical. Although pharmacological and non pharmacological~     methods are used during needle -related procedures to lower painful stimuli nearly all~     patients with CF experience anxiety. Distraction has been shown to be an effective technique~     that directs children's attention away from noxious stimuli. The application of Virtual~     Reality (VR) in the medical field has been shown to be successful already 15 years ago. VR~     has found its use during the medication of burns and in patients undergoing cancer~     treatments whereas so far few studies have been published to assess its efficacy in reducing~     needle related pain and distress in children and none in children with CF.~      Objectives To assess the efficacy of VR in reducing pain and distress during venipuncture in~     children with CF compared to routine care.~      Project description Randomized controlled parallel trial with a 1 to 1 allocation ratio. The~     use of VR compared to standard care during venipuncture in children with CF (age 6-18 years)~     attending the outpatient clinic of the CF Centre of Florence will be compared over the~     period of 1 year. Patients randomly assigned to arm A will use VR during the procedure,~     those patients assigned to arm B will receive routine care.~      Anticipated output Determination of the efficacy of VR in lowering pain and distress during~     venipuncture.~   "
19437|NCT02802826|"~     Chemotherapy forms a significant part of many breast cancer patient's treatment and is~     associated with various common, known adverse effects. For the last few decades, physical~     activity has been emerging as a viable intervention to help many of these adverse effects.~     The study will determine if the provision of a 12-week tailored walking programme, provided~     alongside a home-based exercise prescription from a cancer doctor results in improved levels~     of physical activity and quality of life in patients with breast cancer undergoing~     chemotherapy.~   "
19438|NCT02802813|"~     This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can~     eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR~     (uPCR).~   "
19439|NCT02802800|"~     Field hockey players, recruited from clubs in Jamaica, will be randomized to either a water~     training or land training groups. Persons will be exposed to 6 weeks of plyometric training~     with two sessions per week. Pre and post test measures will be done for lower limb power,~     flexibility and agility. Distance covered, pace, heart rates and exertion during a match~     will also be assessed.~   "
19440|NCT02802787|"~     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life, Pain~     and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction,~     decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods~     Quality of Life, Pain and Fatigue surveys).~   "
19441|NCT02802774|"~     The management of distal radius fractures has been in a state of evolution over the past 30~     years. Treatment has become increasingly focused on obtaining a stable, internal construct~     for quick return to normal, daily activities. With the advent of volar locking plates, the~     wrist fracture is stable before the patient leaves the operating room. As surgical plate and~     screw constructs become more stable, the need for casting and splinting may be less.~      The presumptive next step in operative management of distal radius fractures is to do away~     with the postoperative splint. A review of the available English language literature failed~     to reveal any studies evaluating the use of postoperative splinting and patient outcomes.~      This prospective, randomized study was designed to investigate the use of temporary plaster~     splints versus removable over-the-counter splits versus soft dressings for post-operative~     treatment of extra-articular and intra-articular distal radius fractures. The patients will~     be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.~   "
19442|NCT02802761|"~     Study Cohort:~      All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with~     Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient~     Department~   "
19443|NCT02802748|"~     VENTANA is a window-of-opportunity trial that will explore whether, similar to CDK4/6~     inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior~     anti-proliferative effect than Letrozole alone.~   "
19444|NCT02802735|"~     This two-part study has been designed to evaluate the Pharmacokinetics (PK) of single and~     multiple doses of apremilast in healthy adult male Korean subjects.~   "
19445|NCT02802722|"~     Previous research has shown that people who have been hospitalised for pneumonia are more~     likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months~     after their illness. This risk is linked to raised levels of inflammation. Laboratory~     research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very~     common in the United Kingdom. The investigators are conducting this study to find out if~     taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.~   "
19449|NCT02802670|"~     This is an open-label, non-randomized study to determine the excretion kinetics and mass~     balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in~     healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing~     approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,~     metabolism, and excretion (AME) methodology. The entire duration of the study is up to~     approximately 8 weeks.~   "
19450|NCT02802657|"~     The study will evaluate the efficacy and safety of two different regimens of Conbercept~     (Treat-and-Extend Regimen vs. PRN) in patients with wet AMD. This study is to provide~     long-term safety data in the treatment of patients with wet AMD.~   "
19451|NCT02802644|"~     This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after~     biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.~   "
19452|NCT02802631|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple~     ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin®~     (minocycline) for injection in healthy adult subjects.~   "
19453|NCT02802618|"~     A new education material with 3D technique was developed, by integrating 3D technology in an~     existing evidence-based pulmonary educational program, to enable an increased personalized~     education within a group setting. The investigators believe that this educational model will~     lead to increased adherence to treatment, and suggested lifestyle changes, which in turn~     improves patients' HRQL~      The purpose of this study was therefore to develop a pulmonary educational program in~     interactive 3D visualization technology and to evaluate differences between education with~     3D technique or conventional technique in patient with COPD.~      Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for~     validity and reliability.~   "
19454|NCT02802605|"~     Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic~     patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal~     thrombosis. 3. Monitoring antiXa levels.~   "
19455|NCT02802592|"~     EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)~   "
19456|NCT02802579|"~     Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor~     for later major adverse coronary events. Diagnosis of coronary arterial disease would thus~     be desirable for obese patients, however percutaneous angiography is an invasive procedure~     and associated with a certain morbidity in obese patients. In this study the investigators~     would like to assess whether dual source CT angiography can be used for diagnosis of~     coronary arterial disease in severely obese patients and which settings yield the best image~     quality.~   "
19457|NCT02802566|"~     The purpose of this study is to devise and pilot a BMI-based prenatal vitamin for obese~     pregnant women. Currently, all pregnant women, regardless of body mass index, take the same~     prenatal vitamin. The investigators have found that obese pregnant women have higher levels~     of inflammation and oxidative stress, and a concomitant depletion of specific antioxidant~     micronutrients. The investigators have also found, in an animal model, that decreasing~     inflammation and oxidative stress during obese pregnancy was associated with improved~     offspring outcomes. Here the investigators aim to understand whether a BMI-based prenatal~     vitamin is effective in decreasing markers of inflammation and oxidative stress in~     pregnancies complicated by obesity.~   "
19458|NCT02802553|"~     This is a pilot study to test and characterize the ability of the SmartGoggles system to~     detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test~     the sensitivity and specificity of the SmartGoggles to detect indocyanine green (ICG)~     accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection~     of ICG (Cardio-GreenTM), under standard-of-care application conditions.~   "
19459|NCT02802540|"~     Anorexia is common symptom in cancer patients and is associated with increased morbidity and~     mortality. However timely detection with objective tools is necessary to establish the~     diagnosis of anorexia and to assess the magnitude of change over time. The anorexia~     pathophysiology is not clearly understood and treatment options are limited. Anecdotal~     historical benefits of smoking marijuana on nausea, pain and anorexia led to studies with~     marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol, the main active agent in~     marijuana. The endogenous cannabinoid system with its receptors CB1 and CB2 regulate~     appetite in four functional levels: (1) limbic system (hedonistic quality), (2) hypothalamus~     (appetite stimulant), (3) intestinal, and (4) tissue adipose.~      Nabilone, a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by~     chemotherapy is also used in palliative care units for clinical improvement in increased~     appetite patients in terminal stages, however, there are no clinical trials demonstrating~     this benefit.~   "
19460|NCT02802527|"~     Percutaneous tracheostomy is routinely performed in most intensive care units in the~     world.Several studies have shown that the procedure is safe and economically efficient in~     comparison to open surgical operation in the operating room.~      In the investigator's institution as in a number of institutions in the country and abroad,~     it is acceptable to perform the operation either by withdrawing the endotracheal tube to a~     position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a~     needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the~     anatomy by palpation of the neck, or alternatively by doing the entire procedure under~     bronchoscopic guidance.~      So far, no systematic comparison has been made between the two methods ie PDT without~     bronchoscopy versus PDT with bronchoscopy.~   "
19476|NCT02802319|"~     The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to~     examine histologic wound healing following ridge preservation using bovine xenograft and~     porcine xenograft materials.This protocol involves procedures that are standard care. All~     materials are FDA-approved materials being used in an FDA-approved manner. The test group~     subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test~     group will be compared to an active control group using bovine xenograft (Bio-Oss). The null~     hypothesis is that there will be no significant difference in formation of new vital bone~     between treatment groups (primary outcome).~      Each subjects will have a non-molar tooth extracted and the socket grafted with either test~     or control graft material. At the time of dental implant placement 18-20 weeks after tooth~     extraction a small core biopsy specimen will be removed from the implant site. The core~     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation~     and secondary histologic outcome of % residual graft material.~   "
19461|NCT02802514|"~     The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a~     single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea~     associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore~     the potential differences at the expected time of maximum concentration (Cmax) between a~     long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of~     healthy volunteers assessed by magnetic resonance imaging (MRI). This is a phase IV, 2-part,~     2-period crossover (session), single dose, randomized, single blind (blinded to both the~     subject and the imaging evaluators analysing the MRI data), placebo- and active-controlled~     study in adult healthy volunteers who are susceptible to motion sickness. Part A and Part B~     are the same in design, both consisting of a screening stage, a dosing/assessment stage, and~     a follow-up visit. Data from Part A will inform progression, methods, and analysis plan for~     Part B. Each sequence includes three scanning visits: albiglutide plus scan, exenatide plus~     scan and an off-therapy -natural history scan with a 6-9 week washout period between the~     dosing scans. A total of 24 to 28 subjects will be randomized in the study (Part A and Part~     B). The cross over design is divided into 2 sessions and schedule is as follow, on Day 1~     (either Session 1 (S1) or Session 2 (S2) per, if randomized) subject will under go an~     off-therapy MRI scan, on Day 5 subject will receive a single dose of 50 mg albiglutide or~     albiglutide placebo, and Day 8 subject will receive a single dose of 10 microgram exenatide~     or saline placebo followed by a post-dose MRI scan. At each session subject will receive~     only one active drug (albiglutide or exenatide).~   "
19462|NCT02802501|"~     Tafenoquine (TQ) is an 8-aminoquinoline anti-malarial drug which is in development as a~     single-dose treatment for the radical cure of P.vivax malaria when given with standard doses~     of chloroquine. Currently, the only available drug for radical cure is primaquine (PQ) which~     requires administration over 14 days, resulting in poor compliance. In Indonesia,~     chloroquine has been replaced by artemisinin-based combination therapy (i.e. ACTs) due to~     widespread chloroquine resistance. This study will evaluate the efficacy and safety of a~     single dose of tafenoquine when co-administered with an ACT (i.e. DHA-PQP). This~     single-center, double-blind, double-dummy, randomized study will test the superiority of~     DHA-PQP plus TQ against DHA-PQP alone in the prevention of P. vivax malaria relapse at 6~     months. The study will be conducted in male Indonesian soldiers diagnosed with P.vivax~     malaria on return from deployment to a malarious region of Indonesia. A PQ plus DHA-PQP~     comparator arm is included to provide an informal comparison against the standard 14 day~     treatment for P.vivax malaria in Indonesia. Subjects who are glucose-6-phosphate~     dehydrogenase deficient (G6PD deficient) will be excluded due to the risk of acute hemolysis~     following dosing with 8-aminoquinolines drugs. Subjects who have a recurrence of P.vivax~     malaria during the study will be treated with an ACT plus PQ (0.5mg/kg for 14 days), in line~     with local treatment guidelines. At the end of the 6 month follow up period, any subject who~     has not relapsed will be given open label PQ (0.5mg/kg daily for 14 days) to minimize the~     likelihood of relapse after the study. Approximately 200 subjects will be screened to~     achieve 150 randomized subjects. The total duration of study for each subject will be~     180-195 days. This study is being carried out to support registration of TQ in Indonesia and~     other countries where ACTs are first line therapy.~   "
19463|NCT02802488|"~     Patients with atrial fibrillation are at increased risk of thrombus formation in the left~     heart, especially in the auricula and the atrium. Their presence increases the risk of~     ischemic stroke, especially during cardioversion, performed either by drug or by external~     electric shock. The gold standard to exclude this thrombus and consider cardioversion is the~     transesophageal echocardiography.~      D-dimers, products of the degradation of fibrin, have been studied several times to assess~     the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and~     despite several studies on the matter, there is currently no blood D-dimers value allowing~     to detect the presence of a thrombus with a good predictive value. Correlating the D-dimer~     values with age, as has been done for some years in pulmonary embolism, would give the~     opportunity to create a simple, inexpensive and widely applicable tool to eliminate the~     presence of a thrombus in the left heart.~      If the results are satisfactory, the investigators might consider not using transesophageal~     echocardiography as this examination is unpleasant for the patient and operator dependant,~     unlike a standard blood sampling.~      This study aims to test the following hypothesis: D-dimers values superior or equal to ten~     times the patient's age is predictive of a thrombus.~   "
19464|NCT02802475|"~     The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study~     focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.~   "
19465|NCT02802462|"~     Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes~     vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs)~     contribute to vascular repair process by differentiating into endothelial cells. This study~     investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT)~     exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic~     condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute~     intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30~     minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise~     intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise~     (HE, 100W under 12%O 2 ) were determined before and after various interventions.~   "
19466|NCT02802449|"~     Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive,~     African-American participants will be enrolled in a 8 week study to assess the effect of two~     administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical,~     biologic and genetic factors. The investigators anticipate that at least 300 participants~     will complete this study.~      Written, signed and dated informed consent to participate in the study will be given by the~     participant or a legally acceptable representative, in accordance with the International~     Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable~     regulations, before completing any study-related activities/procedures. The original signed~     and dated consent will be kept in the subject's research file and a copy given to the~     subject. A copy will also be placed in their medical record.~   "
19477|NCT02802306|"~     This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded~     study designed to investigate the safety and efficacy of the Tack Endovascular System. This~     study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in~     the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion~     lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA~     III will also evaluate the safety and efficacy of the device when used to treat a sub-group~     presenting with longer lesions of >150mm and ≤250mm.~   "
20406|NCT02790086|"~     The primary objectives of the study are~        -  to perform a survey on the clinical management of unintentional hypothermia during~          surgery in France.~        -  to assess the impact of perioperative hypothermia on anemia and myocardial injury.~   "
19467|NCT02802436|"~     The advent of endosseous implant restoration has driven an increasing need for alveolar bone~     preservation and/or augmentation strategies. Investigations have explored the physical~     scaffold effects of a wide variety of bone graft materials with each graft material offering~     a more or less attractive surface for bone deposition. The seeding of these scaffolds with~     biologically active material seeks to enhance the osteoconductive effect by influencing~     the temporal or sequential steps which result in the desired end product-new bone.~      Alveolar socket grafts are a common example of these preservation techniques. They are an~     accepted procedure to maximize the retention of alveolar bone post extraction. They appear~     to act as a passive scaffold for clot retention and subsequent bone regeneration.~      The current pilot research project explores addition of a known Bioactive Agent: Platelet~     Derived Growth Factor (PDGF) to test its impact on healing responses. Histomorphometric~     assessments will be utilized on microscopic slide material derived from cores trephined as~     the initial step in the preparation for placement of endosseous dental implants. Outcomes~     measured will include:~      Clinical observation of healing response~      Microscopic measures will be~        -  Measures of residual graft material~        -  New bone formation and new bone contact area with graft~        -  Measures of vascular content~        -  Osteoclast count~        -  Qualitative measures of other marrow components (Cells and relative fiber/ fat content,~          liner cell characteristics.)~   "
19468|NCT02802423|"~     The primary purpose of this study is to determine the safety and recommended dose level~     (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The~     secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with~     Docetaxel monotherapy.~   "
19469|NCT02802410|"~     This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle~     activity during daily activity and sport activity.~   "
19470|NCT02802397|"~     Early ovarian reserve decreased is one of the main causes of infertility for women after 35~     years. The relationship between this decreased and exposure to chemicals, including~     persistent endocrine disruptors or organic solvents, has been little studied. However,~     several in vivo or in vitro experimental studies suggested that these chemicals may impaired~     ovarian function.~      The main objective is to study the relationship between early ovarian reserve decreased and~     exposure to persistent organic pollutants.~      The secondary objectives are to study the relationship between early ovarian reserve~     decreased and exposure to organic solvents and heavy metals.~      Multicenter case-control study. This project will permit to increase the knowledge~     concerning the etiology of early decreased ovarian reserve. Considering that exposure of~     interest are frequent, the results may be important in a public health perspective. If~     associations are observed in this study, the results may encouraged prevention strategy.~   "
19471|NCT02802384|"~     Paget's disease of the bone is a skeletal disorder which results in increased and~     disorganized bone remodeling, leading to dense but fragile and expanding bones. The~     identified genetic causes of Paget's disease of bone only explain why bone is destroyed, but~     not why the bone formed in its place is abnormal.~      Current treatment for people with Paget's disease of the bone is limited to patients with~     bone pain, thought to be related to high rate of bone turnover (breakdown and rebuilding of~     bone) and works by slowing down the rate of bone breakdown. The current treatment does not~     address the excess blood vessels and bone formed.~      This research is being done to understand factors that may promote blood vessel and bone~     formation in Paget's disease of the bone.~   "
19472|NCT02802371|"~     Caring for patients with Alzheimer Disease or Related Disorders (ADRD) is accompanied with a~     caregiver burden that increases with the progression of the disease. This burden can have~     physical, psychological, emotional, social and financial issue on the informal caregivers~     who are often represented as hidden secondary patients. They frequently have a higher risk~     of developing mood disorders as depression, anxiety, stress, sleep disorders and a lower~     quality of life associated with a greater use of psychotropic drugs. They also incur higher~     risk of heart disease and mortality. The embrittlement of the caregiver is a major factor of~     early institutionalization of patient. In the PIXEL study, the mean age of the men~     caregivers was 73.9 years and 64.8 for the women caregivers. Elderly themselves, especially~     spouses, the informal caregivers are also exposed to common chronic diseases and associated~     polypharmacy with a higher risk of developing drug-related problems due to aging and~     negligence of their own health care. These risks are increased mainly in the elderly because~     of changes in pharmacokinetic and pharmacodynamic parameters related to aging, acute or~     chronic diseases and the potentially inappropriate prescription (PIP). Previous studies have~     shown the effectiveness and positive impact of optimization of the therapeutics by a~     clinical pharmacist on the reduction of drug-related problems, length of hospital stay,~     readmission rates, quality of life and mortality. The patient's medication management is~     usually delegated to the informal caregiver, who must also manage his own treatment. The~     caregiver may face difficulties with therapeutics (e.g., inappropriate dosage form, adverse~     effects and patient refusal) that could impact on its compliance with treatment or that of~     his relative. No previous study has evaluated the impact of pharmaceutical collaborative~     care including personalized interview with a clinical pharmacist and optimization of drug~     prescribing among patients with ADRD and their caregivers.~      However, many studies have assessed the effectiveness of non-pharmacological interventions~     on caregiver burden, mood disorders and the patient institutionalization. Meta-analysis~     showed a moderate improvement of the caregiver burden.~      The main objective of the PHARMAID study is to measure the impact of personalized~     pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on~     the burden of ADRD caregivers and assessed at 18-month follow-up.~   "
19473|NCT02802358|"~     Objectives: To describe social and health care provided to our older patients who have been~     admitted in the emergency department (ED) after suffering from a hip or wrist fracture due~     to a fall. To compare among the different hospitals and town halls, the health and social~     care that participants received. To compare the functional dependency and health related~     quality of life (HRQoL) presented by the patients immediately and six months after a fall.~      Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each~     type of fracture (hip or wrist) will be recruited consecutively in the Basque Health~     System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are~     expected to be collected. Data will be collected from ED and hospital clinical records and~     by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and~     HRQoL (SF-36) requesting information on status before the fall, immediately and six months~     later. In addition to this, data referred to care provided to the patients by~     traumatologist, rehabilitation or primary care provider as well as social services in their~     homes after the index episode will be collected.~   "
19474|NCT02802345|"~     To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in~     Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.~   "
19475|NCT02802332|"~     This study will evaluate whether or not provision of a simple card (footlength card) that~     allows identification of low birth weight and/or preterm babies through measurement of the~     length of a baby's foot, can improve basic newborn care behaviors in rural Nepal.~   "
19478|NCT02802293|"~     The purpose of this study is to determine the clinical effects (if any) of~     connectivity-guided repetitive transcranial magnetic stimulation (rTMS) in the treatment of~     major depressive disorder (MDD) to provide clues about the ideal neural networks to target~     for more robust clinical outcomes, and to identify potential biomarkers of treatment~     response including changes in brain network connectivity.~   "
19479|NCT02802280|"~     Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can~     cause changes in other organs highlighting the increased cardiovascular risk (CVR) through~     accelerated atherosclerosis, whose consequences may persist even after healing infection~     with new antiviral treatments. This can have major impact on the health system. Obtaining a~     Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is~     probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C~     virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis.~      Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial~     dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence~     of treatment in the short and medium term on the CVR derived. Studying these same issues but~     in patients with established atherosclerotic disease.~   "
19480|NCT02802267|"~     Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall~     survival in previously untreated AML patients aged 65 years or more who are randomly~     assigned to receive decitabine with or without inecalcitol.~   "
19481|NCT02802254|"~     The aim of this study is to evaluate the efficiency of a minimal intervention on risk~     perception of physical inactivity in patients with known coronary heart disease (CHD) and~     patients at risk for CHD. Therefore half of the patients (intervention group) get a personal~     feedback on their individual level of physical activity measured by pedometers and~     self-report questionnaires plus information about the risk factor 'physical inactivity' for~     heart diseases. Following the hypotheses the feedback should increase the patients risk~     perception of physical inactivity and furthermore increase physical activity.~   "
19482|NCT02802241|"~     The purpose of this study is to investigate placebo effects and peppermint oil in Irritable~     Bowel Syndrome.~   "
19483|NCT02802228|"~     This placebo-controlled study will assess the safety and efficacy of a 90-day course of~     treatment with ifetroban for portal hypertension in cirrhotic patients~   "
19484|NCT02802215|"~     Randomized, placebo controlled clinical trial that evaluate the role of taking metformin~     therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the~     development of gestational diabetes(GDM) and improving pregnancy outcomes.~   "
19485|NCT02802202|"~     To date, there are no valid and reliable pressure pain threshold scales for use in research~     or clinical practice. The existing manual palpation protocols and scales have limited~     support in the literature and our knowledge has not advanced since these scales were~     proposed in the 1990's. Therefore, the purpose of this investigation was to develop a valid~     and reliable PPTS in order to provide an objective means of assessing pressure pain~     thresholds and create a reliable method of communication among clinicians for individuals~     with a diagnoses characterized by MPS and FM. These conditions were chosen based on their~     high prevalence among chronic pain conditions and are also dependent upon the manual~     palpation examination for their diagnosis.~   "
19486|NCT02802189|"~     The purpose of this study is to examine the combine effect of the integrated neuromuscular~     inhibition technique (soft tissue mobilization techniques protocol), in combination with the~     therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of~     symptoms, and to determine whether this combination substantially helps the faster and more~     efficient installation of adaptations of exercising.~   "
19487|NCT02802176|"~     The purpose of this study is to evaluate implantation rate with intra-vaginal culture with~     the INVOcell device versus traditional IVF while using minimal stimulation protocols~   "
19488|NCT02802163|"~     The purpose of this study for Phase l is to determine the maximum tolerated dose of~     panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in~     28-day cycles as induction (initial) therapy to participants with newly diagnosed multiple~     myeloma.~      In Phase ll, investigators will evaluate the safety (side effects) and efficacy~     (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and~     dexamethasone.~   "
19489|NCT02802150|"~     The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral~     consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye~     disease.~   "
19490|NCT02802137|"~     The study investigated the 24-hour efficacy and ocular surface health with preservative-free~     tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol~     fixed combination) in open-angle glaucoma patients insufficiently controlled on latanoprost~     monotherapy and showing signs, or symptoms of ocular surface disease with~     preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma~     patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost~     monotherapy who required further IOP reduction and who demonstrated clinical signs, or~     symptoms of ocular surface disease.~   "
19491|NCT02802124|"~     The aim of this research project is to assess the feasibility and safety of carbon-ion~     radiotherapy for the treatment of localized Chinese hepatocellular carcinoma~   "
19492|NCT02802111|"~     Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction.~     Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R~     form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The~     investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR)~     following administration of albuterol and~   "
19515|NCT02801812|"~     The purpose of this study is to investigate the role of nailfold capillaroscopy in the~     assessment of patients with Systemic Lupus Erythematosus (SLE).~      Primary endpoint:~      - To compare the frequency of major capillaroscopic abnormalities in patients with SLE and~     healthy controls.~      Secondary endpoints:~        -  To compare the frequency of major capillaroscopic abnormalities in patients with active~          and non-active SLE / active SLE and healthy controls / non-active SLE and healthy~          controls.~        -  To study the association of different capillaroscopic parameters and the status of~          subjects (SLE / active SLE / non-active SLE / healthy controls).~   "
19493|NCT02802098|"~     This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects~     will be enrolled in 6 sites.~      Metastatic breast cancer patients with disease progression to bevacizumab-alone maintenance~     treatment will be potential candidates.~      Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in~     monotherapy after the last dose of chemotherapy in the context of bevacizumab plus~     chemotherapy first-line regimens.~      When progression to bevacizumab-alone maintenance treatment occurs, patients will enter the~     trial and will start receiving DURVALUMAB 750 mg (equivalent to 10 mg/kg Q2W) IV infusion,~     if ≥ 30 kg, every 2 weeks together with bevacizumab 15mg/kg IV infusion every 3 weeks. The~     patients will undergo a tumor biopsy before the first dose of DURVALUMAB, and after one~     month of combined treatment - the blood sampling will continue on a monthly basis. The~     treatment will continue until disease progression or for a maximum of 50 weeks.~   "
19494|NCT02802085|"~     Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing~     surveillance plan for the product under investigation.~      For this PMCF only CE-marked medical devices have been used and will be used within their~     intended purpose and no additional invasive or other stressful examinations have been or are~     to be carried out (acc. to MPG §23b).~   "
19495|NCT02802072|"~     To investigate the long-term effects of intracranial implantation of Enterprise stent system~     versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid~     artery stenosis in patients with atherosclerotic ischemic stroke.~   "
19496|NCT02802059|"~     This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension)~     probiotic bacteria administration on the number of both, bacterial and viral infections~     during the first 24 months of infant's life. Half of study participants will receive~     EcN-Suspension, while the other half will receive placebo.~   "
19497|NCT02802046|"~     Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）,~     which is the main feature of chest pain caused by transient myocardial ischemia. Chronic~     stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in~     patients with no significant change in a few weeks. The disease incidence is complex,~     difficult to diagnosis and treatment, clinical should be combined with various inspection~     methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized~     tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the~     determination of coronary blood flow and blood pressure in the heart at rest and hyperemia,~     but no need to additional check or drugs. This technique has been used for noninvasive~     fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the~     ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery.~     Along with the development and progress of computational fluid dynamics, in the resting~     state by computed tomographic angiography of coronary artery(CCTA) image data based,~     simulation of coronary artery maximal hyperemia and according to the 3-dimensional model of~     the traditional method of reconstruction of coronary arterial tree and ventricular muscle~     structure, and in order to calculated coronary blood flow and pressure. FFRCT is a novel~     non-invasive examination method, using computed tomographic angiography of coronary artery~     image data can be calculated FFR, and preliminary study proved that it has a high degree of~     correlation with traumatic FFR. Therefore, this study aims to evaluate the correlation~     between the degree of coronary stenosis and the grading of angina pectoris by noninvasive~     means --FFRCT, in order to provide a new idea for the diagnosis and differential diagnosis~     of coronary heart disease.~   "
19498|NCT02802033|"~     Details regarding the degenerative spine disorders will be collected with a specific focus~     on the use of osteobiologics in treating degenerative conditions and their impact on fusion,~     as well as patient-reported outcomes for these conditions.~   "
19499|NCT02802020|"~     To prospectively document the performance of a FCSEMS for treatment of pancreatic duct~     strictures in patients with painful chronic pancreatitis.~   "
19500|NCT02802007|"~     This is a prospective, non-randomized, open trial to be conducted in overweight and obese~     individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric~     Balloon System for the treatment of overweight and obese individuals. The secondary~     objective is to collect efficacy and device performance information to assist with future~     trial design and device iterations.~   "
19501|NCT02801994|"~     Rational. The mismatch between the activity of the respiratory muscles and the assistance~     delivered by the ventilator results in patient-ventilator disharmony, which is commonly~     observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony.~     Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike~     conventional modes of mechanical ventilation, such as pressure support ventilation (PSV)~     that deliver a constant level of assistance regardless of the patient effort, Proportional~     Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of~     respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator~     asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU~     patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no~     data in patients with severe patient-ventilator dysharmony.~      Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU~     mechanically ventilated patients in intensive care with severe patient-ventilator disharmony~     defined as either severe dyspnea or severe patient-ventilator asynchrony.~      Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting~     severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by~     the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and~     pre inspiratory potential collected from the electroencephalogram. The prevalence of~     patient-ventilator asynchrony will be quantified.~      Expected results. It is anticipated that the switch from PSV to PAV will decrease the~     prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.~   "
19502|NCT02801981|"~     This study will be the first to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in~     Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled,~     dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy~     subjects. Study will be conducted in four periods; subjects will receive either placebo or~     GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period.~     Each period will be separated by washout period (at least 6 days from dosing). Total~     duration of study for each subject will be approximately 5 weeks from the first dosing to~     follow up visit.~   "
19503|NCT02801968|"~     The purpose of this study is to determine the efficacy of Tap block after cesarean delivery~     as a component of multimodal analgesia and evaluation of postoperative drugs consumption.~   "
19504|NCT02801955|"~     For preoperative staging and prediction of peritoneal dissemination of gastric~     adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and~     CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric~     adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal~     levels of tumor markers.~   "
19505|NCT02801942|"~     It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes~     Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes~     (iLN), which will be distinct from changes observed in peripheral blood derived immune~     cells. Therefore this study will assess and compare the molecular immune profile of cells~     derived from the iLN in healthy and NOT1D subjects, to understand the immunological~     processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment~     study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be~     evaluated in the study. A data look will be carried out after the recruitment of a cohort of~     up to 5 healthy subjects, to determine if the quality and quantity of cells derived from~     aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the~     study to meet its primary objective.~   "
19506|NCT02801929|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
19507|NCT02801916|"~     Viscous dietary fibers including oat β-glucan are one of the most effective classes of~     functional food ingredients for reducing postprandial blood glucose. The mechanism of action~     is thought to be via an increase in viscosity of the stomach contents that delays gastric~     emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose~     absorption. Previous studies suggest that taking viscous fibers separate from a meal may not~     be effective in reducing postprandial glycemia. The purpose of this study is to re-assess~     the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g)~     containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal~     of white bread on glycemic responses in 10 healthy humans.~   "
19508|NCT02801903|"~     This is a 21 day, single-center, open-label pharmacokinetic, safety and tolerability study~     in adolescents with moderate to severe acne vulgaris.~   "
19509|NCT02801890|"~     Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's~     the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS).~     Using the potential features of MSCs in the treatment of fibrosis may offer new insights~     into reconstruction the damaged tissues. The project intends to transplant autologous MSCs~     to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study~     infusion effects in clinical, cellular and molecular levels.~      So in this trial, we will evaluate the effects of this intervention after intravenous~     injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis~     patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as~     the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months~     after first injection.~   "
19510|NCT02801877|"~     This study will evaluate and compare a smartphone intervention for depression and anxiety~     that uses machine learning to tailor treatment for participants with the same intervention~     without the machine learning component. The intervention, referred to as IntelliCare,~     delivers participant-specific treatment material and motivational messaging via a mobile~     phone to help individuals with depression and/or anxiety. Information and data received from~     the participant will inform the tailored treatment approach through machine learning. The~     purpose of this study is to compare different versions of the main IntelliCare Hub App (the~     centralized program delivery system) and participant user experience whether with the~     support of a coach or used independently. The RCT aims to obtain information on the~     feasibility and effectiveness of IntelliCare in improving symptoms of depression and~     anxiety.~   "
19511|NCT02801864|"~     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)~     in conjunction with intensive speech therapy will improve sentence production and word~     retrieval in individuals with chronic post stroke aphasia.~   "
19512|NCT02801851|"~     This study will refine and pilot test an innovative, emergency department (ED)-based~     intervention for delirium screening, initial management, and communication with inpatient~     providers, and examine the impact of this intervention on the rate of documentation of~     delirium in the electronic health record by ED and inpatient providers. To achieve this, the~     study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED,~     involving 300 older patients (150 newly enrolled intervention participants, 150 historical~     controls (comparison group) currently being collected), that has 4 key components:~     systematic screening for delirium using the Confusion Assessment Method (CAM), informing~     providers of the screening result, a checklist protocol for initial delirium management~     based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and~     communication with inpatient providers of delirium screening results.~      The study has two primary aims. The first is to refine and test the feasibility and~     acceptability of the SCREEN-ED intervention. The second is to examine the impact of~     SCREEN-ED on rate of delirium documentation and secondary outcomes (length of hospital stay,~     repeat ED visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled~     intervention group compared with 150 already collected historical controls.~   "
19513|NCT02801838|"~     Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes~     in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major~     therapeutic challenge. Its measurement involves a self-assessment by the patient, and by~     definition, a certain level of communication. Consequently, a large proportion of the~     ICU-population (non-communicating) misses its evaluation and potential benefits associated~     with its control. In other hand, electrophysiological markers that help to detect and~     quantify dyspnea regardless of the patient's cooperation, has been developed and validated~     as dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic~     inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the~     electroencephalogram (EEG). Because of its complex implementation in daily practice the~     research team has developed alternatively a behavioral score called IC-RDOS that provides~     reliable dyspnea assessment also without patient participation. Validated in conscious~     patients, it has not been yet validated in non-communicating patients.~      Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a~     simple and reliable assessment of dyspnea in this specific population.~      Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical~     ventilation, using comparison with the tools validated for reliable measure of dyspnea in~     non-communicating patients (EMG, EEG).~      Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and~     electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene,~     parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea~     (ventilator settings or pharmacological intervention), initiated by the clinician in charge~     of the patient.~      Expected results : Observe a strong positive correlation between the IC-RDOS and~     electrophysiological markers (amplitude of the electromyogram and presence and magnitude of~     PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological~     markers after therapeutic interventions.~      Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection~     and quantification of dyspnea in non-communicating patients, this study should ultimately~     improve the management and the better living of ventilated patients in intensive care~   "
19514|NCT02801825|"~     The main purpose of the study is to compare two ultrasound-guided arterial cannulation~     procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral~     artery cannulation.~   "
19516|NCT02801799|"~     This trial is a part of the project: 'A novel technique for reliable, precise and safe~     postoperative pain management' (project no. 65-2014-3).~      The purpose of the trial is to investigate the effects of changing peri-neural infusion~     rates of ropivacaine 0.2% on the duration of nerve block.~      Intervention:~      Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2%~     is to be infused in one of five infusion rates, using a peri-neural catheter.~      Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the~     sciatic nerve.~   "
19517|NCT02801786|"~     This is a double-blind placebo-controlled randomized clinical trial to test the use of~     tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography,~     intending to include 450 patients distributed between the three groups.~   "
19518|NCT02801773|"~     The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of~     Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root~     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and~     monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive~     scaling and periodontal treatment and randomly will be assigned over an experimental (SRP +~     probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per~     day during 3 month.~   "
19519|NCT02801760|"~     This study involves a one-time, web-based quantitative structured self-complete~     (web-based) survey for all subjects and a qualitative semi-structured (qualitative)~     interview for a selected sub-sample of subjects to evaluate the consent processes in~     association with research outcomes, specifically early adherence to Pre-exposure Prophylaxis~     (PrEP) and Human Immunodeficiency Virus (HIV) seroconversion at any point during~     participation in the ATN 110 or ATN 113 study.~   "
19520|NCT02801747|"~     The present study targets the large population of persons living with HIV/AIDS (PLHA) in the~     U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral~     therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the~     urgent need for new research approaches to advance intervention science, and the proposed~     project employs a new, potent, and innovative research methodology, the Multiphase~     Optimization STrategy (MOST), a framework for developing highly efficacious, efficient,~     scalable, and cost-effective interventions. The proposed study has the highest public health~     significance: it addresses a vulnerable population of PLHA, including the critically~     important subpopulations of men who have sex with men (MSM) and substance users; will~     develop an efficient and cost effective intervention to increase engagement along the HIV~     care continuum for these vulnerable groups; and addresses two areas highlighted in the~     August 2015 notice on research priorities from the NIH Office of AIDS Research~     (NOT-OD-15-137), namely, engaging PLHA in prevention/treatment services, and reducing~     HIV/AIDS-related racial/ethnic disparities.~   "
19521|NCT02801734|"~     i. Project Background Patients with advanced lung cancer have a high symptom burden and low~     quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced~     lung cancer patients, but previously tested models are not feasible for widespread adoption.~     Hence, the aim of this study is to pilot a more sustainable nurse-led intervention -~     Enhancing Quality of life in Patients (EQUIP).~      ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim~     to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly,~     the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention.~     Thirdly, the investigators aim to determine the data completion rate of patient reported~     outcome measures in the context of the EQUIP trial.~      iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited~     and randomized to the EQUIP intervention or usual care (control) group. Patients randomized~     to the EQUIP intervention group will receive four face-to-face sessions with a palliative~     care nurse. The content of these educational sessions will equip patients with the knowledge~     and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.~      All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L),~     the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time~     points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also~     be recorded. Additionally, participants in the intervention group will complete a feedback~     survey after each intervention session.~      A total sample of 60 patients (30 in each arm) will be recruited.~      Clinical Significance~      If successful, this study will lead to a larger scale phase III trial which tests various~     components of the EQUIP intervention, in order to develop a sustainable and effective model~     for the provision of palliative care to advanced lung cancer patients.~   "
19522|NCT02801721|"~     1. Burden: Anaemia is a public health problem in our country. Fifty one percent young~          children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and~          the main cause of this problem is iron deficiency. Research findings show that Iron~          deficiency leads to delayed development and even reduce working capacity. All these~          impact negatively on quality of life and loss of national gross domestic product (GDP).~        2. Knowledge gap: Little is known about long-term effects of early life iron deficiency~          anemia on development and behaviour of children after correction with iron supplements.~          There is also scarcity of information if early life psychosocial stimulation added to~          iron supplementation to these anemic children have long term benefits compared to~          non-stimulated anaemic children or non-anaemic children~        3. Relevance:~           The aim was to conduct a follow up study to examine whether the IDA children, who~          recovered from iron deficiency and received additional more intense psychosocial~          intervention catch up to their optimum development in later life at school age, similar~          like non-anaemic peers.~        4. Hypothesis (if any):~             1. The benefit of early iron supplementation in addition to Psychosocial stimulation~               on growth and development of IDA infants appears in later life.~             2. Addition of early psychosocial stimulation in treated IDA children help them catch~               up to their non-anemic peers in development over time.~        5. Study Objective(s)~             1. To determine the long term effect of early psychosocial stimulation provided at~               the age of 6-24 months in addition to iron treatment in IDA children on their~               growth (height, weight and Head Circumference), IQ, executive function, school~               achievement, fine motor, memory and behaviour~             2. To compare the growth and development of IDA infants with non-anemic infants after~               7 years of an intervention with iron supplementation and psychosocial stimulation.~        6. Methods:~      Sample: All children who participated in the iron and stimulation study at the age of 6 to~     24 months (n=424).~      Identification of sample: Using the addresses and by tracking through available mobile phone~     numbers.~      Measurements~      In the current follow-up, at the age of around 8-9 years all the available children will be~     measured for:~        -  WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)~        -  School achievement~        -  Number Stroop~        -  SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ)~        -  Memory test of NEPSY (neuropsychological test)~        -  Digit span forward and backward~        -  Middle childhood HOME~        -  Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2~          (age -band 2 for 7-10 years)~        -  SES Anthropometric measurement: Children's height, weight and head circumference~   "
19523|NCT02801708|"~     The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG~     for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke~     or transient ischemic attack (TIA) of undetermined cause after completion of a standard~     clinical work up including an initial 24-hour Holter monitoring.~   "
19533|NCT02801578|"~     Ibrutinib is currently FDA approved and commercially available for the treatment of CLL.~     However, some researchers think the approved dose may be unnecessarily high.~      The goal of this clinical research study is to compare 3 different daily doses of ibrutinib~     to learn how these doses affect the disease and your body. Researchers think that if a lower~     dose of ibrutinib can be found to be as effective as the currently approved dose this may~     help to lower the risk of side effects.~   "
19534|NCT02801565|"~     Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro~     fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.~   "
19524|NCT02801695|"~     Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and~     fetal morbidity and mortality. The early clinical manifestations are the occurrence of a~     maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply~     to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a~     disease that causes prematurity and currently the only known cure is delivery of the~     placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia~     is directly related to a failure of placental NO production. In this context, several~     clinical trials have tested the effect of NO donors such as L- arginine. However,~     supplementation with L -Arginine in a randomized trial in Nantes, has proved to be~     ineffective in severe vascular IUGR.~      Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine~     escapes uptake in the liver and appears directly in the peripheral blood converted by the~     kidney in arginine, released into the systemic circulation, Citrulline may therefore be more~     effective in the treatment of pre-eclampsia.~      This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy~     for patients with pre-eclampsia before 36 weeks.~   "
19525|NCT02801682|"~     Invasive Candida infections are serious complications in immunocompromised patients~     including those undergoing treatment for cancer but occur also in patients treated in ICUs.~     Survival rate of invasive candidiasis is associated with early initiation of antifungal~     therapy (15% mortality rate for candidemic patients with antifungal therapy on day 0 related~     to the culture date of the first blood sample positive for yeasts compared to 41% for~     patients who received antifungal therapy on day 3). Up to date, no laboratory method or~     clinical decision rule is available for correct anticipation of invasive candidiasis which~     would avoid delays in appropriate antifungal therapy initiation. In clinical practice~     culture based methods (e.g. blood cultures) miss up to 50% of invasive candidiasis cases.~     Preemptive antifungal therapy is therefore often initiated in critically ill patients after~     Candida has been isolated from various non-sterile patient samples even without any~     sufficient evidence for invasive candidiasis. The disadvantages of this approach include~     over- and undertreatment of patients (up to 50% of candidemia cases are missed, and on the~     other hand 89% patients are treated unnecessarily), increased selective pressure for the~     development of antifungal resistance, potential risk of adverse drug reactions, and~     increased costs (expenses for antifungal therapy account for half of the antimicrobial~     medication budget in tertiary care hospitals). In addition, no survival benefit could be~     demonstrated by this strategy in ICU patients.~      The aim of this study is to identify biological markers to anticipate or support the~     diagnosis of invasive candidiasis in ICU patients, to overcome current deficiencies in~     detection of invasive candidiasis and consequently to differentiate between Candida spp.~     colonization and invasive Candida infection. The investigators intend to examine time~     dependent courses of potential host and pathogen derived biomarkers as well as innate or~     acquired predispositions for invasive candidiasis; e.g. automated (1→3) ß- D- Glucan tests,~     DNA in serum blood samples, pathogen recognition receptors and serum markers like~     interleukin (IL)-1, IL-2, IL-6, IL-10, IL-12, IL-17A, IL-17F, IL-22, IL-23, Tryptophan,~     Kynurenine, composition of indigenous microbiota of gastrointestinal and lower respiratory~     tract and skin, and risk factors for invasive candidiasis like underlying diseases and~     treatments. The study should contribute to improved assessment of ICU patients at risk for~     invasive candidiasis and to improved diagnosis of invasive candidiasis in ICU patients. In~     clinical practice the reliable differentiation between infection and colonization will allow~     more targeted antifungal therapy leading to enhanced antifungal treatment initiation on the~     one hand (in cases of true invasive candidiasis) and to reduction of unnecessary antifungal~     treatments and treatment costs on the other hand.~   "
19526|NCT02801669|"~     The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients~     with non-valvular NVAF aged 80 years or older who are ineligible for available oral~     anticoagulation therapy.~   "
19527|NCT02801656|"~     Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and~     mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to~     kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal~     microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT~     in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize~     patients to oral encapsulated FMT or oral Vancomycin.~   "
19528|NCT02801643|"~     The present study would be the first to investigate the relationship between reward-induced~     dopamine (DA) release and neural function using a combined PET/fMRI approach. Data from this~     project conducted in healthy subjects will provide preliminary data for a larger grant~     application to study patient populations with known abnormalities in DA including~     schizophrenia, major depressive, substance use, and eating disorders.~   "
19529|NCT02801630|"~     This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device~     for the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that~     receives the sham device. Subjects will be monitored for subjective criteria of pain and~     quality of life, as well as objective measurement of analgesic usage.~   "
19530|NCT02801617|"~     Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by~     Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensor~     therapy in subjects with primary open angle glaucoma or ocular hypertension.~      Study design: a muticentric, prospective, crossover (2x2), double blind clinical study.~     Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.~     Patients in the period 1: In the first sequence 50 patients will be assigned to receive the~     ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop QD during 30 days and the~     second sequence 50 patients will be assigned to receive the ophthalmic solution: PRO-067 1~     drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period~     2: the pharmcological intervention change to the opposite therapy for 30 days.~   "
19531|NCT02801604|"~     The practicality of most ADHD medications is not or only moderately examined under long term~     routine conditions. Therefore, in this multi-centre, multi-national prospective~     non-interventional study, a recommended follow-up time of 12 months will investigate the~     course of the therapy in children and adolescents with ADHD with prior MPH treatment and~     their medication change to dexamfetamine in several European countries under daily routine.~      It consists of a baseline visit under MPH or another ADHD drug therapy, a change to~     dexamfetamine, the prospective description of the titration phase and a 12 month maintenance~     phase. Data on the use of dexamfetamine in routine clinical practice will be collected to~     describe how dexamfetamine is prescribed, titrated and used in the population of ADHD~     patients and how these factors influence the general intensity of ADHD and safety events.~     This study will collect real world data of dexamfetamine and compare descriptively the~     general intensity of ADHD according to ADHD classification and the impairment due to ADHD~     under therapy with dexamfetamine to the general intensity of ADHD according to ADHD~     classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore~     the utilization of dexamfetamine will be assessed with regards to treatment persistence,~     compliance, proportion of patients discontinuing treatment and reason for discontinuation.~     Due to the fact that patients will be treated according to local medical practice it is~     possible that medication will be changed during the observation period.~   "
19532|NCT02801591|"~     Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection~     assisted in the treatment of the patients with poor ovarian response in vitro fertilization~     and embryo transfer.~   "
19535|NCT02801552|"~     This study evaluates the clinical effect of regenerative endodontic procedure using PRF in~     immature permanent teeth with apical periodontitis. Half of participants will receive the~     PRF instead of blood clots in the regenerative endodontic procedure, while the other half~     will receive a blood clots in the regenerative endodontic procedure.~   "
19536|NCT02801539|"~     This study is being done to test the effects of respiratory muscle training (RMT) in~     patients with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles.~     The results of this study will help design future research studies about RMT in LOPD. The~     goals of this study are to decide if sham-RMT is a useful control condition for RMT and to~     choose the best ways to measure the health benefits of RMT in LOPD.~   "
19537|NCT02801526|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of~     the two separate drugs in healthy male volunteers.~   "
19538|NCT02801513|"~     Despite considerable progress in the understanding of depression, the treatment of those who~     have entered a chronic course of the disorder still represents a major challenge. In order~     to develop more effective interventions it is important to learn more about maintaining~     mechanisms and the ways in which these can be addressed. Recent research has outlined~     aberrations in neurophysiological parameters that may serve as risk factors underlying~     tendencies to engage in maladaptive responses to negative mood, and that may be particularly~     pronounced in patients with chronic depression. Initial evidence suggests that such deficits~     may not be easily amenable through established treatments. The current study investigated~     whether mental training using mindfulness mediation, as compared to an active control~     training, could alter these parameters in chronically depressed patients.~   "
19539|NCT02801500|"~     The purpose of this study is to determine whether the magnetic compressive anastomosis has a~     better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.~   "
19540|NCT02801487|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of~     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment~     at the MTD. Participants will be treated with CIRT with escalating dose regimens along with~     concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in~     terms of acute and subacute toxicity observed during and within 4 months after the~     completion of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is~     determined, the MTD will be used as the recommended dose to patients fulfilling the~     inclusion criteria in the Phase II part of the trial.~   "
19541|NCT02801474|"~     Patients with a posterior malleolar fracture were recruited and assigned to the direct~     reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation~     of the fracture, the quality of fracture reduction was evaluated in radiograph and CT~     images. Functional outcome was evaluated at the last follow-up.~   "
19542|NCT02801461|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral~     nerve. The purpose of this study was to assess the effect of extracorporeal shock wave~     therapy on cubital tunnel syndrome.~   "
19543|NCT02801448|"~     Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from~     pancreatic islets and insulin resistance of target cells. The investigators have extensive~     pre-clinical data suggesting that BSE through its high content of the isothiocyanate~     sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could~     therefore benefit both patients with T2D and individuals at risk for the disease.~     BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The~     investigators aim to study the clinical effect of using BSE as a dietary supplement on~     glucose tolerance and insulin sensitivity.~   "
19544|NCT02801435|"~     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of~     Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.~   "
19545|NCT02801422|"~     The aim of this fMRI study is to investigate neural indices of relapse in cannabis~     dependence. The development and maintenance of drug addictions have been associated with~     deficits in cognitive control, craving and impaired stress regulation. Therefore, neural~     markers of brain processes underlying the beforementioned components will be studied.~     Subsequent follow-up drug use interviews will reveal associations between relapse in~     cannabis dependence and alterations in brain networks of cognitive control, craving and~     stress.~   "
19546|NCT02801409|"~     Some studies suggest that regional anesthesia/analgesia may decrease the rate of~     recurrence/metastasis in patients after cancer surgery. However, evidences from prospective~     studies are still lacking. The purpose of this randomized controlled trial is to investigate~     the effect of epidural anesthesia/analgesia on the rate of recurrence/metastasis in patients~     undergoing lung cancer surgery.~   "
19547|NCT02801396|"~     Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses~     bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects~     will complete a questionnaire for each study lens.~   "
19548|NCT02801383|"~     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for~     the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV~     type infections and clinical negative conversion.~   "
19549|NCT02801370|"~     This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study~     in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a~     single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the~     external auditory canal of the affected ear(s).~   "
19550|NCT02801357|"~     The purpose of this study is to evaluate the relative exposures of lofexidine and its major~     metabolites in subjects seeking buprenorphine dose reduction.~   "
19551|NCT02801344|"~     Protein requirements in individuals who participate in endurance-based exercise training~     have been suggested to be greater than the current recommended dietary allowance (RDA).~      Our recent study using the minimally invasive indicator amino acid oxidation (IAAO)~     technique have suggested that protein requirements in young men are at least 30% higher than~     the recommended protein intake.~      The present study will investigate the impact of protein sufficiency on protein metabolism~     and performance during intensified training periods as a means to further our understanding~     of the nutritional requirements for the endurance athlete.~   "
19552|NCT02801331|"~     The purpose of this study is to examine the efficacy of a specially-constructed crib~     mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a~     complementary, non-pharmacological intervention for treating drug withdrawal in newborns~     exposed to opioids in utero.~   "
19553|NCT02801318|"~     Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU),~     mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been~     described in ICU patients and is considered as a risk factor for delirium but its role is~     still unknown. It is therefore essential to identify whether sleep deprivation and more~     specifically REM sleep alterations could facilitate occurence of delirium in ICU.~   "
19554|NCT02801305|"~     Digital ulcers are one of the most prevalent complications of scleroderma (systemic~     sclerosis). There can be found few surveys on effect of topical agents on healing process of~     the ulcers. Thus, the aim of this study is to assess and compare the effects of topical~     diltiazem on SSc digital ulcers versus topical nitroglycerin.~   "
19555|NCT02801292|"~     The primary objective of the proposed study is to determine the potential role of Ketamine~     as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in~     acute (VOC).~   "
19556|NCT02801279|"~     The purpose of the present study is to develop a long term cost-effectiveness (efficient~     protocol, playful context, and practical strategy) training program for school-age children~     with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training~     program for children with Cerebral Palsy.~   "
19557|NCT02801266|"~     This project develops a contraceptive counseling protocol (CCP) grounded in scientific~     evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended~     pregnancy among women. The project develops and refines the CCP using focus groups and~     in-depth interviews with (a) key administrators in the national office of Planned Parenthood~     (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and~     (d) clients of the health centers. The CCP uses scientifically grounded principles for~     guiding effective decision making and provider-client communication. Ten Title X clinics are~     randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual~     (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study~     participation in each clinic, yielding about 1,400 participants (half control and half CCP).~     Immediately following their counseling session, women complete a computer-administered~     interview that serves as a fidelity check and permits evaluation of the effects of the CCP~     on variables associated with counseling satisfaction. All women are re-interviewed by phone~     6 months later and 12 months later. The effect of the CCP on method-choice effectiveness,~     method switching, gaps in protection, and use accuracy are evaluated.~   "
19558|NCT02801253|"~     Management of prosthetic joint infections (PJI) is a challenging task. These infections~     include different clinical and microbiological settings calling upon various treatment~     strategies according to infection type (acute or chronic), bone quality, the involved~     micro-organism and the patient's general condition and willing.~      Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a~     high operative risk prolonged suppressive antibiotic therapy can be used.~      Lack of large prospective studies motivated the conception of this cohort with a long term~     follow up, regardless to PJI management procedures.~   "
19559|NCT02801240|"~     Individuals with IBD are at risk for nutrient deficiencies. This prospective,~     non-randomized, open-label study will assess the effect of a nutrition support product on~     nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's~     disease will be enrolled in the study and asked to take the product for 12 weeks. The~     primary measures of the study are several blood markers of nutritional status.~   "
19560|NCT02801227|"~     The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding~     time from induction of labor (IOL) to delivery among primiparas at term with prelabor~     rupture of membrane (PROM) and an unfavorable cervix.~   "
19561|NCT02801214|"~     This fMRI study investigates neural correlates of emotion regulation, emotion processing and~     craving in recreational cannabis users.~   "
19562|NCT02801201|"~     At the time of birth, nearly 5% of children are in breech presentation. This type of~     presentation requires a medical environment and leads to more frequent use of Caesarean~     sections. This is why the external version can be proposed, usually from the 36th week. Its~     success rate is 40%, and is usually performed under simple sedation. One of the causes of~     failure is the lack of relaxation of the uterus, which could be higher in case of deeper~     anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate~     superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary~     and secondary objectives.~   "
19563|NCT02801188|"~     Fracture femur is a common that results in severe pain. Many methods of regional and~     peripheral analgesia have been described to treat such pain. In this study the investigators~     consider using paravertebral block to treat post-fracture pain. Additionally, they consider~     adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this~     block and hence postoperative analgesia.~   "
19564|NCT02801175|"~     Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation~     either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage~     emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography~     (TEE) immediately before and following left atrial ablation (1 month post). The change in~     LAA-EFV will be compared between the two groups (RF versus Cryo).~   "
19565|NCT02801162|"~     Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative~     clinical data at various time points. Compare the methods associated with obtaining blood~     gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of~     the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system~     parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid~     changing context.~   "
19591|NCT02800798|"~     The purpose of this study is to find the correlation between high risk OSA (obstructive~     sleep apnea) patient, based on Stop-bang screening tool and preeclampsia~   "
20007|NCT02795312|"~     This is a study designed to mindfulness based stress reduction (MBSR) training program to~     assess feasibility and acceptability of the intervention. Participants will participate in a~     9-week training program and complete pre-and post-questionnaires. Participants will have the~     option of participating in a follow-up focus group.~   "
19566|NCT02801149|"~     Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid~     fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often~     challenging, particularly at the time of presentation, this study aims to evaluate whether~     the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with~     a suspected scaphoid fracture, with negative findings from the initial conventional~     radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care~     and patient experience.~      This study is a single centre randomised, non-blinded, prospective study. Participants will~     be randomised, following the initial negative conventional radiography, to either: no~     further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The~     study considers a follow-up period of 6 months.~   "
19567|NCT02801136|"~     This research study is examining the effects of a cognitive behavioral intervention (an~     intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic~     seizures (PNES, episodes resembling epileptic seizures but with no medical explanation).~     Participants engage in 8 individual therapy sessions consisting of either cognitive~     behavioral therapy or supportive therapy.~   "
19568|NCT02801123|"~     Background: As more people survive cancer, the importance of research on effective~     interventions for improving quality of life (QOL) amongst survivors is growing. Two~     interventions with a substantial evidence-base are Mindfulness-Based Cancer Recovery (MBCR)~     and Tai chi/Qigong (TCQ). However, these interventions have never been directly compared.~      Objectives: (1) To compare MBCR and TCQ to each other and a waitlist control condition using~     an innovative, randomized, preference-based comparative effectiveness trial (CET) design~     that takes into account potential moderating factors that might predict differential~     response. (2) To investigate the impacts of MBCR and TCQ on a range of biological outcomes~     including immune processes, blood pressure, heart rate variability, stress hormones,~     cellular aging, and gene expression.~      Methods: The study design is a preference-based multi-site randomized CET incorporating two~     Canadian sites (Calgary, AB and Toronto, ON). Participants (N total = 600). Participants~     with a preference for either MBCR or TCQ will get their preferred intervention; while those~     without a preference will be randomized into either of the two interventions. Within the~     preference and non-preference groups, participants will also be randomized into immediate~     intervention groups or a wait-list control. Outcome measures to be assessed pre- and~     post-intervention and at 6-month follow up include psychological outcomes (mood, stress,~     mindfulness, spirituality, post-traumatic growth), QOL, symptoms (fatigue, sleep), physical~     function (strength, endurance), and exploratory analyses of biomarkers (cortisol slopes,~     cytokines, blood pressure/heart rate variability, telomere length, gene expression), and~     health economic measures.~      Hypotheses: The investigators theorize that both MBCR and TCQ will improve outcomes amongst~     survivors relative to treatment as usual, particularly if patients have a strong preference~     for a particular intervention. Specifically, the investigators hypothesize that MBCR may be~     superior to TCQ on measures related to stress and mood. Conversely, TCQ may be superior to~     MBCR in improvement of physical and functional measures.~   "
19569|NCT02801110|"~     Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects~     1% of the population older than 60 years. The disease presents as a movement disorder~     manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural~     instability along with cognitive and behavioral disturbances and symptoms of other non-motor~     systems dysfunction. The pathophysiology of the motor dysfunction in PD is related to~     gradual loss of nigrostriatal dopaminergic neurons (originating from the substantia nigra~     (SN) compacta to the striatum) leading eventually to depletion of dopamine in the striatum.~      Striatal fluorine-18 isotopologue for L-3,4-dihydroxyphenylalanine([18F] F-DOPA) uptake~     follows a typical spatiotemporal pattern along the course of disease starting with a~     decreased uptake in the dorso-caudal putamen (contralateral to the side of predominant motor~     involvement) that progress to the caudate nucleus.~      The role of traditional magnetic resonance imaging (MRI) in the evaluation of PD is aimed~     mainly to differentiate idiopathic PD from secondary parkinsonism (e.g. vascular) and from~     other degenerative but atypical parkinsonian syndromes (e.g.Progressive supranuclear palsy (~     PSP), Multiple system atrophy (MSA) etc.) that are associated with distinct structural~     features and therefore help establishing the diagnosis. However, new MR sequences such as~     diffuse tensor imaging (DTI) and susceptibility-weighted imaging (SWI) are now being~     investigated to evaluate the nigrostriatal dopaminergic neurons and iron accumulation in the~     SN, respectively.~      Resting-state functional magnetic resonance imaging (fMRI) that depicts brain network~     organization has been shown to be altered in patients with PD. In this technique, temporally~     synchronous, spatially distributed, spontaneous low frequency blood-oxygen level-dependent~     signal fluctuations in task-free settings are further clustered into maps of functional~     large-scale neural networks. Lower network efficiency that worsens as disease progresses has~     been shown in patients with PD.~      Recently, it has been shown that the integration of MRI and PET is technically feasible. The~     investigators believe that PET/MRI offers true multimodality imaging by combining anatomy,~     function and molecular processes that will allow more accurate identification of disease~     progression.~      To the best of our knowledge, this will be the first study to evaluate idiopathic PD (IPD)~     with 18F FDOPA PET/MRI.~      The aim of the study is to assess the feasibility of the modality and to evaluate both~     visually and quantitatively the association between the dopamine metabolism measured in the~     striatum by 18F-FDOPA PET with structural and functional MR findings in patients diagnosed~     with IPD with asymmetrical motor signs.~   "
19570|NCT02801097|"~     This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical~     activity of RRx-001 administered in combination with irinotecan.~      RRx-001 is associated with resensitization to irinotecan in tumors that are previously~     refractory. This effect has been attributed to the ability of RRx-001 to restore the~     expression of aberrantly silenced genes, thus re-establishing pathway functions. However,~     resensitization may have more than one mechanism, among them Pgp pump inhibition and~     vascular modulation, leading to improved penetration of standard chemotherapy.~   "
19571|NCT02801084|"~     The study proposed in this protocol aims to document the physiological, subjective,~     behavioral, and neural effects of reduced environmental stimulation (floating) in patients~     with current or prior eating disorder. The primary aim of this study is to determine the~     safety of this intervention. Secondary aims including determining whether floating has an~     impact on symptom reports such as those related to anxiety and eating disorders.~   "
19572|NCT02801071|"~     The purpose of the study is to show that the intake of L-citrulline improves muscle function~     in patients with Post-Polio Syndrome.~   "
19573|NCT02801058|"~     A wide number of osteopathic techniques focusing on diaphragm have been proposed but,~     although systematically and efficiently used, there is a general lack of evidences able to~     clarify how and to which extent osteopathic manipulative treatment (OMT) on diaphragm is~     effective and determines a modification in muscles contractility and motion as well as an~     objective determination of the benefit on the patients receiving treatment.~      This study therefore aims at investigating whether, and how, a single session of selected~     osteopathic diaphragmatic techniques are able to affect muscle motility and thickness,~     assessed by ultrasounds, in a sample of healthy subjects and to compare results versus a~     group receiving a sham therapy and another one of non-treated subjects.~   "
19574|NCT02801045|"~     This study evaluates from the patient's perspective which elements of the own artistic~     creative process are the source of a beneficial change for him/her and how those elements~     influence in their end of life experience.~   "
19575|NCT02801032|"~     In a double blind placebo-controlled cross-over study the effect of tadalafil on blood flow~     velocity in the large arteries of the brain, cortical brain oxygenation, peripheral~     endothelial function, and endothelial biomarkers will be tested in patients with lacunar~     stroke caused by cerebral small vessel disease.~   "
19576|NCT02801019|"~     Vitamin E incorporated highly cross linked polyethylene (E-XLPE) was developed to increase~     oxidative resistance of highly cross-linked polyethylene (XLPE) without affecting mechanical~     properties. The investigators evaluated this type of polyethylene in a randomized clinical~     study, using Radiostereometric Analysis (RSA). The objective of this study was to compare~     the early-term wear of E-XLPE to a compression annealed polyethylene liner (C-XLPE,~     ArComXL®). The clinical outcome at two years was not expected to be affected by the choice~     of polyethylene.~   "
19592|NCT02800785|"~     For the past 130 years, appendectomy has been the standard treatment for appendicitis.~     Recent studies from Europe have challenged the notion that surgery is the best option,~     showing that antibiotics alone can treat appendicitis without a need for appendectomy in as~     many as 3 out of 4 patients and without safety issues for up to one year of follow up.~     Despite these results, it remains to be determined if the antibiotic strategy is as good as~     an appendectomy for the outcomes that most patients care about. The Patient-Centered~     Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy~     (CODA) trial will be the first American, and largest-ever randomized trial of the issue and~     its results should help surgeons and patients make more informed healthcare decisions.~   "
19633|NCT02800252|"~     Therefore, the aim of this study is to investigate the effectiveness of daily~     supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct~     therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of~     chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical~     trial.~   "
19577|NCT02800980|"~     Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic~     lymphadenectomy performed for treatment or staging purposes in the management of some~     cancers. Management procedures are: single or repeated puncture, prolonged drainage with~     drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which~     management option is most optimal, should be guided by two principles: first to control~     patient's symptoms, second to apply the least invasive but effective way to treat LC, taking~     into account that the patient has undergone major surgery recently, and often needs adjuvant~     treatment at the moment when symptomatic LC is diagnosed.~      The aim of this study is to validate feasibility, safety and efficacy of a minimally~     invasive management of a symptomatic LC - drainage with the usage of vascular catheter~     followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.~      Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated~     volume of LC and other organs failure if appear is recorded. Management options are~     discussed with patient, and if the method with catheter insertion and drainage is chosen~     than the patient is eligible for the study. After vascular catheter insertion into LC and~     fluid evacuation, patient is followed with active drainage. Patients with drainage only are~     observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is~     considered. In case a patient does not agree to sclerotherapy, or there are~     contraindications, or it is doctor's decision that drainage alone is sufficient, than the~     prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen~     used for sclerotherapy, it's volume, time intervals between repeated infusion depend on~     institution practice.~      Data concerning feasibility, safety and efficacy are noted in designated templates.~     Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.~      The study is observational. Primary outcome measure is to establish efficacy of the method.~     Secondary outcome measures are safety and patient's experience on the treatment.~      Investigators hope to establish step-by-step guidelines for optimal, minimally invasive~     management of symptomatic lymphocele.~   "
19578|NCT02800967|"~     The existing scientific evidence from both in vitro and clinical trials supports the notion~     that polyphenols can modulate platelet function. Beyond being central players in haemostasis~     and thrombosis, platelets have crucial roles in the development of atherosclerosis, mediated~     through their interactions with monocytes and endothelial cells. Disturbed platelet function~     correlates with other risk factors, including hypertension and obesity, and the progression~     of cardiovascular diseases (CVD), postulating platelets as rational targets in CVD~     prevention. Thus, the effects of polyphenols on disturbed platelet function would contribute~     to their pleiotropic beneficial effects of on cardiovascular health. Aronia juice is a rich~     source of polyphenols including anthocyanins, procyanidins, phenolic acids and flavonols.~     However, there is no clinical evidence on the effects of aronia juice consumption on~     platelet function and related CVD factors. The purpose of this study is to investigate the~     effects of Aronia juice polyphenols on platelet function and other CVD risk factors in~     subjects with moderate CVD risk.~   "
19579|NCT02800954|"~     The Primary objective of this study is to compare serum levels of Macrophage-Colony~     Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a~     population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in~     a control population.~   "
19580|NCT02800941|"~     Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the~     indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension~     (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their~     low level of proof in the PHT. Last but not least, anticoagulants are known to be the~     principal cause of iatrogenic hospitalization (major bleeding).~      In this study, patients are all followed during one year, to determine the annual frequency~     of major bleedings (according to the International Society on Thrombosis and Haemostasis~     (ISTH) international definition). Each event notified is validated by an independent~     committee for clinical events.~   "
19581|NCT02800928|"~     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a~     Human Laboratory Model of Stress-precipitated Smoking Behavior.~   "
19582|NCT02800915|"~     The goal of the project is to study whether interdisciplinary follow- up performed via~     telemedicine to the patient in his or her own home, will improve the quality of the~     healthcare services offered to a particular group of patients. The investigators believe~     this could increase knowledge and expertise, give significant socioeconomic benefits, and~     allow greater accessibility to specialized healthcare services, as well as increase the~     user-involvement for patients and those working in primary healthcare.~   "
19583|NCT02800902|"~     Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the~     body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a~     rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV)~     have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims~     to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery~     system as an adjunct to scaling and root planing (SRP) for the treatment of degree II~     furcation defects.~   "
19584|NCT02800889|"~     This is a phase 1, open-label, dose escalation study to evaluate the safety,~     pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed~     or refractory solid tumors (excluding those with CNS tumors) or lymphoma.~   "
19585|NCT02800876|"~     Retrospective study to evaluate the impact of computational wall stress analysis based on~     computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional~     predictor for rupture with dedicated software.~   "
19586|NCT02800863|"~     The purpose of this prospective, multicenter, single arm post-approval study is to~     demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion~     (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for~     permanent implants.~   "
19587|NCT02800850|"~     Many older adults with dementia living in long-term care facilities experience depression~     and agitation, which cause angst and personal suffering. Prior to this research, evidence~     was inconclusive but indicated that bright light exposure may reduce depression and~     agitation in long-term care residents with dementia. The purpose of this study was to~     determine if the degree of improvement in depression and agitation scores over the course of~     eight weeks was significantly greater in persons with dementia receiving bright light~     exposure than in persons with dementia receiving placebo light exposure. Sixty individuals~     participated in the study, with 30 in the bright light group and 30 in the low level light~     group.~   "
19588|NCT02800837|"~     Prospective, non-randomized, multi-center study assessing the long term safety and efficacy~     of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected~     left main coronary artery disease.~   "
19589|NCT02800824|"~     To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and~     Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects~   "
19590|NCT02800811|"~     First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study~     evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.~   "
19593|NCT02800772|"~     Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic~     ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline~     solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome~     was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance~     of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to~     achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct~     cannulation in the acetic acid group versus saline group.~   "
19594|NCT02800759|"~     Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC).~     Nutraceuticals containing CMO are used to improve knee pain despite the lack of~     placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial~     is to explore the minimal effective dose of CMO for relieving knee joint pain.~   "
19595|NCT02800746|"~     The objective of the present study is to determine the impact of preoperative IV-iron~     (ferric carboxy maltose) supplementation on postoperative hematocrit values and allogenic~     blood transfusion amount in patients undergoing elective prognathic surgery.~   "
19596|NCT02800733|"~     anxiety disorder is one of the major public health problems worldwide. 25% of people~     experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as~     the most prevalent anxiety disorder. Saffron has previously approved as an effective~     adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our~     knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant~     therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron~     (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:~   "
19597|NCT02800720|"~     A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation~     Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating~     fibromyalgia syndrome.~   "
19598|NCT02800707|"~     This study will determine the influence of two non-caloric sweeteners on glucose metabolism~     via the gut microbiome in adult men and women.~   "
19599|NCT02800694|"~     Labor pain is the most severe pain most women will endure in their lifetimes. The most~     complete and effective method of pain relief during childbirth is neuraxial labor analgesia~     which provides adequate analgesia without maternal or fetal sedation. Epidural and combined~     spinal-epidural (CSE) analgesia are the standard techniques performed in the developed~     countries. Having an epidural catheter in place produces flexibility with labor management.~     The catheter can be dosed intermittently for parturients in whom labor is prolonged, who~     require surgical manipulation for vaginal delivery, or who require cesarean section for~     delivery (1). However, unavailability of full-time epidural services in low-resource~     countries results in minimal or no analgesia provided to laboring parturients. The~     suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly~     progressing labor in primiparous and multiparous women and was found that it may be a useful~     alternative for painless labor in the case of limited resources for epidural analgesia~     (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia,~     particularly for primiparous women.~      A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response~     relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at~     about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing~     the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5~     mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized~     that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of~     analgesia. So, this dosage combination can be used at an early stage in~     appropriately-selected primigravida parturients. The purpose of this study is to investigate~     the safety and effectiveness of single-dose spinal analgesia to control labor pain in~     properly-selected primiparous women in a tertiary referral maternity hospital~   "
19600|NCT02800681|"~     The purpose of this study is to identify psychopathology (psychiatric symptoms) that can~     differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no~     language impairment Autism Spectrum Disorder) (AS) in young adults.~      With our present knowledge, the differentiation between AS and SD can be difficult, as they~     both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of~     not being as everyone else'. Studies suggest that adults with AS symptoms are either~     overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry.~      A 'correct' diagnosis is important, as it is the first step towards the most optimal plan,~     treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness~     is the description of present psychopathology.~      To identify symptoms that can differentiate between the two disorders, we will use~     semi-structured interviews to explore present psychopathology in young adults with typical~     symptoms of SD and AS respectively, with special focus on presence of alterations in~     self-experience. Alterations in self-experience are typical for the schizophrenia spectrum,~     and are therefore not thought to be equally present in AS and SD.~      The hypotheses are that the total level of altered experiences is higher in SD, than in AS,~     and with a different pattern of altered experiences in SD than in AS. If the hypotheses are~     true, an examination of altered self-experience will be valuable to aid clinical~     differentiation between the two disorders.~   "
19601|NCT02800668|"~     Implantation of a duodenal-jejunal endoluminal bypass liner (DJBL) has shown to induce~     weight loss and to improve metabolic parameters. DJBL is a reversible endoduodenal sleeve~     mimicking biliodigestive digestion while lacking risks and limitations of bariatric surgery.~      Effects on metabolic control, body mass parameters, appetite regulation, glucose tolerance,~     organ health, and lipid profile were determined in 16 morbidly overweight patients with type~     2 diabetes mellitus. In addition, relevant hormones (Leptin, ghrelin, gastric inhibitory~     peptide, glucagon-like peptide 1, and insulin) were measured by enzyme-linked immunosorbent~     assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA) at 0, 1 and 32, and 52~     weeks post-implant following a mixed meal tolerance test, which was applied for diagnostic~     purposes only.~   "
19602|NCT02800655|"~     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),~     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect~     information about patients taking their ARV medications. The wearable sensor records~     information, which is uploaded wirelessly to a mobile device and then to a secure computer.~     Together the sensors and the mobile device transmitting the information to the study~     computer are called a digital health feedback system (DHFS), which gives healthcare~     providers information about when patients have taken their ARV medications.~      The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to~     the HIV patient population; that patients will persist with its use; and that the system~     provides valid, accurate measures of adherence.~   "
19630|NCT02800291|"~     M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes~     in Canada. The primary purpose of this study was to identify food intake in residents and~     compare this to recommendations, as well as determine influential determinants of food~     intake.~   "
19603|NCT02800642|"~     Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports~     blood away from the retina (the very back portion of the eye) becomes blocked, causing the~     leakage of fluid into the retina and thereby causing a swelling of the macula (the portion~     of the retina responsible for fine vision). This swelling is called macular edema. When the~     macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been~     shown to reduce the amount of fluid and blood leaked into the retina. It can help to~     stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been~     approved for the treatment of macular edema secondary to CRVO in the United States (US),~     European Union (EU), Japan, and other countries.~      The study is considered research because, although the study drug is already on the market~     for macular edema secondary to CRVO, there are no studies available that address the~     questions of what are useful intervals for treating and assessing patients, how do they~     differ among patients, and how are criteria applied for retreatment. The purpose of this~     study is to evaluate the effectiveness, treatment interval, and safety of the treatment~     regimen (pattern for administering treatment) in subjects with macular edema secondary to~     CRVO. In addition, this study will explore new imaging methods for assessing the affected~     eye.~   "
19604|NCT02800629|"~     The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3~     inhibition with MCP to placebo for the treatment of knee osteoarthritis.~   "
19605|NCT02800616|"~     Unhealthy lifestyles in early childhood are a major global health challenge. These~     lifestyles often persist from generation to generation and contribute to a vicious cycle of~     health-related and social problems. We present a study protocol that examines the~     effectiveness of two novel, integrated healthy school interventions. One is a full~     intervention called 'The Healthy Primary School of the Future', the other is a partial~     intervention called 'The Physical Activity School'. These intervention approaches will be~     compared with the regular school approach that is currently common practice in the~     Netherlands. The main outcome measure will be changes in children's body mass index (BMI).~     In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic~     differences, and societal costs will be examined.~   "
19606|NCT02800603|"~     The purpose of the study is to evaluate the first Canadian implementation project of the~     Family Check up (FCU), an evidence-based prevention and early intervention model that~     engages families and communities in reducing the burden of childhood emotional and behaviour~     problems (EBP).~   "
19607|NCT02800590|"~     This is a phase II, randomized, single-blind study in 75 adult participants undergoing~     elective colonoscopy for screening or diagnostic purposes. This study is designed to test if~     3 different ABP-700 infusion regimens can safely and consistently produce satisfactory~     conditions for a colonoscopy. It is also intended to quantify pharmacodynamic effects,~     readiness for discharge, cognitive and memory function, and both patient and provider~     satisfaction related to these dosing regimens.~   "
19608|NCT02800577|"~     In England over 800,000 patients each year are either newly diagnosed with depression or~     present with a new episode of depression in primary care. The majority of patients do not~     respond to the first drug prescribed and have to try several different antidepressants~     before an effective treatment is found. Antidepressants have a slow clinical onset of~     action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide~     General Practitioners (GPs) as to whether their patient is responding to the prescribed~     successive treatments. This often results in delays of many months before patients return to~     good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was~     developed and optimised to be sensitive to early changes in emotional bias that are~     indicative of successful antidepressant treatment. The current investigation is an~     exploratory study using the GP-ETB.~      It will test the predictive ability of the GP-ETB with regard to later subjective drug~     response and nonresponse. The study will recruit depressed patients from primary care~     settings. There are no study drugs prescribed as part of this clinical investigation.~     Eligible patients will have been prescribed citalopram by their GP prior to study entry. The~     decision to initiate treatment with citalopram will be independent of study participation.~     The duration of the study is 5 months. Each patient will be required to attend 3 visits and~     total duration of the study for the patient will be 46 weeks. During the visits patients~     will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer.~     Sensitivity and specificity data collected during this study will be used to develop a~     computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected~     1 week after initiation of antidepressant treatment.~   "
19609|NCT02800564|"~     Optimal infant and young child feeding practices are largely inadequate in rural and poor~     households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation,~     and growth monitoring and promotion (GMP) activities among infants and young children (IYC).~     An essential component of GMP activities is to counsel mothers to practice optimal IYC~     feeding and health practices, but most of the time this is completely missing or not~     specific enough to be effective.~      This study will test the effect of a mass media nutrition education program on caregiver~     infant and young child feeding knowledge, attitudes and practices using a community-based~     cluster randomized design. Formative research will first be undertaken to determine the~     beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their~     infants and young children with members of the community (caregivers with children~     under-five, men and elderly women).The information gathered will then be used to design~     specific messages that directly address the IYC feeding challenges of the community.~     Clusters will be randomized into active (radio messages with in-person engagement and~     follow-up) and passive (only radio messages) arms of the intervention. Farm Radio~     International (implementers of the mass media programming) will ensure the regular broadcast~     of twice weekly messages for a period of about 12-18 months.~   "
19610|NCT02800551|"~     This study will compare pain (primary end-point) and local metastatic tumor control~     (secondary end-point) after dose-intensified image-guided fractionated stereotactic body~     radiation therapy (SBRT) for painful mass-type spinal metastases versus conventional~     radiation therapy.~   "
19631|NCT02800278|"~     Usually, cervical spine fractures are not considered as osteoporotic fractures. However,~     recent studies show that odontoid fractures are the most common fractures of the cervical~     spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this~     observationnal study is :~        -  to describe the different type of odontoid fracture and to characterize bone status in~          elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma~          energy.~        -  To describe short and long term outcomes~   "
19632|NCT02800265|"~     Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout~     extracts in tablet form, hypothesized to activate protective cellular pathways including~     detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to~     evaluate both bioavailability and its bioactivity in cheek cells.~   "
19611|NCT02800538|"~     The previous research by one of our members in the research team (H. Miller) suggests a~     possible influence of oral nutrients intake of certain fat or carbohydrates (glucose,~     fructose) on executive control. On the other hand, another previous study from our group (L.~     Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids~     on subjective and neural responses to negative emotion induction. The purpose of this study~     therefore is to examine the effect of intragastric administration of certain fatty acids and~     carbohydrates on executive control in healthy volunteers.~      Therefore two group of healthy volunteers are invited to the study. The first group will be~     randomly administered one of the three fatty acid emulsions or placebo via a nasogastric~     tube in each of the visits， while the second group receives one of two carbohydrates or~     saline in a random order. After the exposure period, participants will use a computer to~     perform there different tasks to measure executive control. During each study visit, regular~     measurements of emotion, physical sensations, as well as blood glucose will be assessed.~     Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal~     function.~   "
19612|NCT02800525|"~     The objective of this study is to evaluate the efficacy and safety of picosecond 532 and~     1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched~     532 and 1,064 nanometers laser.~   "
19613|NCT02800512|"~     The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for~     treatment of pelvic organ prolapse.~   "
19614|NCT02800499|"~     The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective,~     non-interventional and observational study within the Korean COPD patients. The prevalence~     of early COPD (mild to moderate COPD based by 2011 GOLD(the Global Initiative for Chronic~     Obstructive Lung Disease) guideline) is high in Korea. However, the patients with early COPD~     are not underdiagnosed due to mild symptom. The purpose of this study is to investigate~     early COPD characteristics and disease course and to form a guideline for early detection of~     COPD patients and prevention of progression to severe COPD.~   "
19615|NCT02800486|"~     Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy,~     either individually or in combination. Present therapies are inadequate, as evidenced by the~     low 5-year survival rate for brain cancer patients, with median survival at approximately 12~     months. Glioma is the most common form of primary brain cancer, afflicting approximately~     7,000 patients in the United States each year. These highly malignant cancers remain a~     significant unmet clinical need in oncology. GBM often has a high expression of EFGR~     (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods~     of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and~     tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring~     GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of~     250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and~     prevent tumor progression in patients with recurrent, residual GBM.~   "
19616|NCT02800473|"~     This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of~     the inner bladder using white light and blue light excitations and (ii) high resolution~     panoramic images of the bladder inner wall.~      All participants will undergo fluorescence cystoscopy: the first half using first a~     reference medical device for fluorescence cystoscopy already on the market then using the~     innovative device specifically developped for the CyPaM2 project.~      The other half will undergo fluorescence cystoscopy using first the innovative then the~     reference medical device.~   "
19617|NCT02800460|"~     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used~     in many French and international centers for the treatment of severe forms of Parkinson's~     disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50~     to 80% on average. The main advantage of DBS is that the surgery has low morbidity and~     mortality, it is adaptable to the patient's symptoms and its effect is reversible. This~     treatment is now a routine and more than 85,000 patients worldwide have benefited from the~     installation of this system. Since 1997, this treatment is available to patients followed in~     the Pitié Salpêtrière (GHPS).~      The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve~     with the use of high-field MRI. However, several new issues and inherent in that high-field~     MRI should be evaluated before the images can be used directly.~      The chosen sequences must be short to be feasible, minimizing patient discomfort, and~     evaluated on several patients to ensure the low interindividual variability. In addition,~     the quality of the display on all of the sections should provide a reliable~     three-dimensional information. Finally, the quality of targeting and its possible~     improvement should be checked.~   "
19618|NCT02800447|"~     1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD~          regimens for patients with advanced Hodgkin's lymphoma.~        2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma~   "
19619|NCT02800434|"~     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy~     and the quality of life of patients, social and familial exclusion, and dependence on third~     parties for everyday activities.~      The management of these patients is nearly exclusively through the use of prostheses.~     Certain patients refuse this solution, or remain penalized by the absence of sensation, the~     lack of precision in movements, and body image issues related to the amputation; the double~     graft of hands and forearms may, in this circumstance, be the only solution.~      The objective of this pilot study was designed to evaluate the cerebral plasticity of~     patients who undergo bilateral hand allograph~   "
19620|NCT02800421|"~     Besides contrast-induced acute kidney injury (CI-AKI), adscititious vital organ damage such~     as hypoxic liver injury (HLI) may affect the survival in patients with ST-elevation~     myocardial infarction (STEMI). Therefore, the investigator sought to evaluate the prognostic~     impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary~     intervention (PCI).~   "
19621|NCT02800408|"~     The purpose of this study is to determine how well the body absorbs the carotenoid~     beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically~     engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this~     new type of corn contains higher amounts of BCX, it appears more orange in color than~     traditional types of corn. Understanding how well the body can absorb the BCX from the corn~     may help companies develop food products that may have improved nutritional quality.~   "
19622|NCT02800395|"~     According to several reports, the oxidative stress and the nutrition could have an impact in~     the Alzheimer disease.~      The association of these two parameters measurements and the cognitive impairment decline~     could help in a predictive diagnosis of cognitive decline evolution in patients presenting~     cognitive disorders.~      This is a monocentric prospective routine care clinical trial on patients showing~     cognitive troubles especially memory complaints.~      The objective is to demonstrate a correlation between oxydative stress and nutrition~     biomarkers and the clinical evolution of patients complaining of cognitive impairments.~      The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock~     test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail~     making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in~     case of MRI contraindication) will be realized during the study inclusion phase in the usual~     intake of patients. Whole blood samples for the oxydative and nutrition biomarkers~     measurements will be taken at the study inclusion day during the stay at the Day hospital~     dedicated to the routine intake of patients issued from the memory consultation.~      In this study, the principal evaluation criteria will be the MMSE score evolution during the~     60 months of the patients follow-up, measured during the routine visits scheduled~     approximately every 6 months, according to the french national authority for health~     recommendations. It will allow evaluating the correlation between the cognitive decline~     evolution measured by MMSE during the Alzheimer disease or related diseases method during~     the 2 years follow-up, and the oxydative stress blood markers.~   "
19623|NCT02800382|"~     Lipid per oxidation final products and free oxygen radicals are thought as initiator role~     for developing of cancer in the body. Level of paraoxonase in the patients with cancer~     varies. In this research, the investigators investigated the contribution of level of serum~     and bronchoalveolar lavage paraoxonase in the differentiation of benign and malignant lung~     disease patients. This research includes the patients that are diagnosis of lung cancer~     (research group) and benign pulmonary disease (control group) participated by accepted~     fiberoptic bronchoscopy (FOB).~   "
19624|NCT02800369|"~     This research study is being carried out to study a new way to possibly treat human cervical~     intraepithelial neoplasia (CIN) without invasion.~      Persistent infection with specific types of human papillomavirus (HPV, most frequently types~     16 and 18) may lead to precancerous lesions(CIN). If untreated, these lesions may progress~     to cervical cancer within many years. In the infected cells, HPV expresses the oncoproteins~     E6 and E7, both of which play key roles in maintaining viral infection and promoting~     carcinogenesis. Previous studies has demonstrated that E7 alone, but not E6, is sufficient~     to immortalize human keratinocytes in vitro and induce high-grade cervical dysplasia in a~     transgenic mouse model. These data indicated that E7 may dominate the malignant progress in~     HPV-infected cells.~      The agents zinc finger nucleases (ZFNs), called ZFN-603 and ZFN-758, which can cleave the~     HPV16 and HPV18 E7 oncogene specifically. ZFN-mediated disruption of HPV16 and HPV18 E7 DNA~     directly decreased the expression of E7, induced type-specific apoptosis in HPV16- and~     HPV18-positive cells, and inhibited cell growth.~      The purpose of this study is to determine whether ZFN-603 and ZFN-758 are effective in the~     treatment of HPV16- and HPV18-positive cervical intraepithelial neoplasia.~   "
19625|NCT02800356|"~     To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in~     patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to~     Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in~     best-corrected visual acuity, atrophy progression and safety.~   "
19626|NCT02800343|"~     Metabolic acidosis is a common complication that patients experience in the early~     postoperative period following cardiac surgery. Increasingly, the composition and volume of~     intravenous fluids administered during surgery have been implicated in the development of~     postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion~     technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery,~     involves the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of~     large volumes of 0.9% sodium chloride has previously been linked with the development of~     hyperchloraemic acidosis. We hypothesize that the volume of mechanically salvaged of red~     blood cells re-infused into patients undergoing heart surgery contributes to the acidosis~     that occurs in the early postoperative period.~      To test this, we have designed an observational cohort study to check for correlation~     between the volume of cell salvaged blood infused during surgery and the severity of~     postoperative acidosis (which will be assessed using data from routine arterial blood gas~     samples).~   "
19627|NCT02800330|"~     Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and~     oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When~     regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH~     increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to~     the less soluble non-ionized form which reduces regorafenib bioavailability and exposure.~     Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this~     drug-drug interaction (DDI) confronts pharmacists and oncologists with challenges in~     clinical practice. In this study the investigators will therefore evaluate the impact of~     PPI-induced intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST~     and mCRC.~   "
19628|NCT02800317|"~     Chemotherapy in clinically node positive breast cancer patients is increasingly~     administrated in a neoadjuvant setting. The standard treatment regimen in these cases is~     then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node~     dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3~     patients, indicating a complete absence of axillary metastases after completion of NAC. In~     such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less~     invasive axillary surgery which can accurately assess axillary pCR is therefore preferred~     over standard ALND in all patients. In case of detection of remaining axillary lymph node~     metastases by this less invasive axillary surgical procedure, completion axillary treatment~     is standard of care.~      The novel RISAS procedure is introduced as a possible less invasive axillary staging~     procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in~     axillary node positive breast cancer combined with a Sentinel node procedure. The iodine~     seed in the axillary lymph node metastasis will be placed prior to start of NAC.~   "
19629|NCT02800304|"~     M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway~     for Acute Care, in five medical units in five hospitals in Canada.~   "
19634|NCT02800239|"~     Protein requirements in active individuals have been suggested to be greater than the~     current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adolescents have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order~     to characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in adolescent, females using~     the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
19635|NCT02800226|"~     This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and~     explore potential biomarkers of treatment response~   "
19636|NCT02800213|"~     Investigators compared tidal volumes for single rescuer ventilation using a modified bag~     valve mask with a supplemental external handle versus a conventional bag valve mask in a~     manikin model.~   "
19637|NCT02800200|"~     The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and~     potential treatment for patients with kinds of musculoskeletal disorders. Although few~     clinical studies have showed beneficial effect of PRP and ESWT for regeneration of~     peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.~   "
19638|NCT02800187|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral~     nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave~     therapy on carpal tunnel syndrome.~   "
19639|NCT02800174|"~     To validate the long-term effects of implantation of the self-expanding Smart nitinol stent~     system for the treatment of severe atherosclerotic carotid stenosis in a 2-year follow-up~     study of a large patient cohort~   "
19640|NCT02800161|"~     The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating~     nature, characterized by lifelong recurrent episodes and residual intraepisodic~     symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have~     reported dramatic illness-associated morbidity and premature mortality in bipolar patients.~     The efficacy and safety of antidepressant drug treatment in BD is the subject of~     long-standing debate based on a scientific literature that is limited and inconsistent. The~     evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is~     insufficient evidence for treatment benefits with antidepressants combined with mood~     stabilizers. The need to develop new agents for the treatment of depression, and in~     particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In~     the past years there has been increasing interest in the health benefits of supplemental~     and/or dietary substances in the treatment and prevention of depression. The disaccharide~     trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation.~     In vivo studies with trehalose show cellular and behavioural beneficial effects in animal~     models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a~     process that had been recently suggested to be involved in the therapeutic action of~     antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like~     properties and that the trehalose induced behavioral changes are possibly related to~     trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that~     trehalose also augments lithium effects in animal models (mice). Based on this hypothesis,~     this project aims to conduct a study to assess the efficacy and tolerability of trehalose as~     adjunctive treatment to lithium in bipolar depression.~   "
19641|NCT02800148|"~     To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the~     treatment of Inflammatory Lesions of Rosacea~   "
19642|NCT02800135|"~     Acute kidney injury (AKI) is a common disorder and associated with high morbidity and~     mortality. However, distinguishing transient AKI from persistent AKI may help in~     individualizing treatment and limit short and long term consequences of AKI. Previous~     studies suggested usual urinary indices to perform poorly for separating transient from~     persistent AKI in an unselected population of critically ill patients. The recent KDIGO~     (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional~     strategies in estimating renal short term prognosis.~      Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically~     ill patients. This stress test performance was found to be good in predicting capacity to~     identify those patients that will progress to advanced stage AKI. Additionally, FST~     performance was higher than those of usual renal biomarker. The limited sample size of this~     preliminary study however precluded adjustment for usual confounders including oliguria.~      The primary objective of this study is to assess diagnostic performance of FST in~     differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic~     performance of FST in predicting need for renal replacement therapy, and to confirm FST~     results after adjustment for confounders.~   "
19643|NCT02800122|"~     This is an observational retrospective single-center study (CHRU of Nancy) in patients cared~     for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.~      The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea~     by a medical team of emergencies of CHRU of Nancy.~   "
19644|NCT02800109|"~     The purpose of this study is to measure the impact of maternal malaria on child growth in~     the two first years of life in relation to fetal growth.~      This study is following a birth cohort of children born to pregnant women enrolled in the~     study Impact of malaria infection in pregnancy on fetal and newborn growth (protocol~     OXTREC 14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2~     years of age using routine anthropometric measurements such as weight, length, arm and head~     circumference. A few additional tests will enhance the sensitivity of the study outcomes~     with minimal risk. These tests will include anthropometry, screening, nutrition~     questionnaire and neurodevelopmental assessment.~   "
19645|NCT02800096|"~     Comorbidity between problem gambling and mental health concerns such as anxiety and~     depression is common. Further, the treatment needs of people with co-occurring gambling and~     mental health concerns may be different from those of problem gamblers who do not have a~     co-occurring mental health concern. The present study is a two-arm, double blinded, parallel~     group randomized controlled trial (RCT) that will evaluate whether there is a benefit to~     providing access to mental health Internet interventions (G+MH intervention) in addition to~     an Internet intervention for problem gambling (G-only intervention) in participants with~     gambling problems who do or do not have co-occurring mental health concerns.~   "
19675|NCT02799693|"~     This is a single-arm non-randomized prospective observational cohort study to assess the~     outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular~     tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF)~     catheter ablation. Following ablation, patients will be monitored for 6 months. The duration~     of the study is up to 4 years.~   "
19646|NCT02800083|"~     -  The study primary end point is the decrease in the number of monthly heavy drinking~          days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the~          double blind Randomized Treatment (RT).~        -  The Secondary end points will be designed to assess safety and tolerability and to~          further investigate the effect of pitolisant on other alcohol use criteria (e.g. total~          alcohol consumption, number of abstinence days), craving as well as the improvement in~          mental health (depression, sleep) and quality of life.~             -  Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined~               as mean daily alcohol consumption in g/day over a month (28 days).~             -  Percent of patients without HDDs during the 24 weeks RT phase of the study.~               (Continuous Controlled Drinking=CCD)~             -  Percent of Abstinent Days during RT phase (PAD)~             -  Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)~             -  4-week point prevalence abstinence at end of treatment~             -  Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase~             -  Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase~             -  Beck Depression Inventory (BDI) during 24 week RT phase~             -  Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.~             -  Treatment retention during 24 week RT~             -  Quality of life (SF-12) during RT phase~             -  Percent patients without HDDs during the OL follow up period~             -  Quality of life (SF-12) during OL phase~             -  Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase~             -  Treatment retention OL phase Safety will be assessed by evaluation of treatment~               emergent adverse events (TEAE), physical examinations, clinical laboratory tests~               (blood chemistry, hematology, and urinalysis), subsequent end of treatment~               potential withdrawal, evaluation scales and physical examination, measurement of~               heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at~               ECG Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥~               60 ms it will be required to check ECG by second measurement after lying down 10~               minutes.~   "
19647|NCT02800070|"~     This is a first-in-human study for the treatment of Fabry disease. Eligible patients will~     have an autologous stem cell transplantation using CD34+ cells that are transduced with the~     lentivirus vector containing the human alpha-gal A gene. The researchers of this study would~     like to see if the re-introduction of transduced cells will help increase the levels of~     alpha-gal A enzyme levels and to determine the safety and toxicity of autologous stem cell~     transplantation using CD34+ cells transduced with lentivirus vector containing the alpha-gal~     A gene. This study's objective is to determine the safety and toxicity of lentivirus~     alpha-gal A transduced CD34+ cells in adult males with Fabry disease.~   "
19648|NCT02800044|"~     The overall goal for this pilot clinical trial is to explore the accuracy and acceptability~     of a non-invasive, wearable glucose sensor in patients living with DM. This study will~     compare needleless glucose sensor readings with glucometer measurements from patients with~     type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.~   "
19649|NCT02800031|"~     To compare between the efficacy of IOTA simple rules and pattern recognition method in the~     differentiating between benign and malignant adnexal masses~   "
19650|NCT02800018|"~     The first aim of this study is to analyse perinatal risk factors leading to hypoxic~     ischaemic encephalopathy in term and near term neonates born in Switzerland who were~     admitted to the neonatal and intensive care units offering hypothermia therapy.~      Further, investigators would like to analyse the influence of these perinatal risk factors~     on the severity of encephalopathy during and after hypothermia therapy.~   "
19651|NCT02800005|"~     As the number of obesity continues to increase, surgical oncologist pay more attention to~     the effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body~     mass index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area~     (AFA) calculated by computed tomography is popular because of its validity of fat~     distribution. There is still no consensus which of BMI and AFA could be the more effective~     measurement and more accurate to evaluate effect of obesity on surgical outcomes and~     survival. Gastric cancer is one of the most common digestive system cancers, and gastrectomy~     is the primary therapeutic options.It is important to compare the different measurements(BMI~     or AFA) to assess obesity and effect on surgical outcome and survival for gastric cancer~     patients.~   "
19652|NCT02799992|"~     Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients,~     characterized by serous retinal detachment in the macular region. We evaluated half-dose~     verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.~      Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio~     to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of~     805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical~     coherence tomography findings were compared between groups.~   "
19653|NCT02799979|"~     Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival~     is very poor and has been closely related to right ventricular dysfunction. Current~     prognostic equations rely mostly on right heart catheterization data. The identification of~     simple echocardiographic prognostic factor is urgently needed. It could help identifying~     with a non invasive method, high risk patients who could benefit from an intensive specific~     therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV~     volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.~      The aim of this study is to validate a new software for 3D analysis of the right ventricle~     and assess its prognostic role in pulmonary hypertension.~      To do so, the investigators will realize a prospective monocentric longitudinal cohort~     study, including 100 pulmonary hypertension patients. Echocardiographic data will be~     collected at baseline and after 6 months.~   "
19654|NCT02799966|"~     Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands~     and arms. MyndMove is a non-invasive medical device that uses short, low energy electrical~     pulses with surface electrodes to cause muscle contractions to produce a full range of~     reaching and grasping movements, which the patient is unable to perform by him/herself.~      By using MyndMove therapy to help the individual move their arms and hands as he/she~     attempts to carry out typical reaching and grasping movements, the individual improves their~     ability to perform these tasks voluntarily.~      The purpose of this study is to study the effectiveness of MyndMove therapy in improving the~     ability of individuals to move their arms and hands.~   "
19676|NCT02799680|"~     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of~     differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33)~     infusions in patients with relapsed / refractory acute myeloid leukemia (AML).~   "
19677|NCT02799667|"~     The investigators aim to show that single use negative pressure dressings can decrease the~     rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at~     a tertiary medical center by randomizing women to receive either a single use negative~     pressure dressing or the standard dressing after cesarean delivery.~   "
19678|NCT02799654|"~     In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and~     radiological results of the cementless Excia T® prosthesis in routine clinical use shall be~     assessed and the migration taking place in the first 24 months evaluated.~   "
19655|NCT02799953|"~     Objective: To develop and evaluate a technology-augmented self-monitoring model using a~     randomized controlled trial to demonstrate whether patients with co-morbid type 2 diabetes~     mellitus and hypertension can improve their glycemic and blood pressure control, adherence~     to medication regimens, and other relevant outcomes by using a tablet-based consumer health~     information technology (CHIT) to support the self-monitoring and self-management of their~     chronic conditions.~      Design: A two-group, randomized controlled trial with follow-up assessments 8, 12, 16, and~     24 weeks after the baseline evaluation.~      Setting: Patients' homes.~      Participants: Two hundred and ninety-six adult patients with type 2 diabetes mellitus and~     hypertension who receive their health care from a local community health service network or~     a major hospital will be recruited.~      Interventions: Participants in the technology-augmented self-monitoring model (intervention~     group) will use a tablet-based, interactive touch screen self-monitoring system to monitor~     and manage their chronic conditions. The system is designed to augment patients' abilities~     to assess, record, and review their health signs while providing text-, audio-, and~     video-based resources supporting disease self-care. The participants in the usual-care group~     will perform conventional self-monitoring.~      Outcome measures: The primary outcomes will be glycemic control measured by changes in~     HbA1c,blood pressure control assessed by changes in systolic and diastolic blood pressure,~     and medication compliance. The secondary outcomes will be adherence to diabetes and~     hypertension self-care activities and knowledge of diabetes and hypertension.~      Implication: This study will improve our understanding of the clinical value of CHITs in~     chronic disease self-monitoring and self-management.~   "
19656|NCT02799940|"~     The objective of the study is to determine the correlation between the physiological~     variables and the degree of consolidation in lung computed tomography in patients with acute~     respiratory distress syndrome~   "
19657|NCT02799927|"~     Objective: The study's main purpose is to evaluate and compare the clinical and radiographic~     outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend~     plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital~     primary molars with carious lesions approaching the pulp. Study design: 80 four-to-eight~     year-old patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A~     split-mouth design trial is being conducted in order to compare both IPT interventions on~     160 bilateral primary teeth, without signs or symptoms of irreversibly inflamed or~     degenerative pulp tissue. Teeth were treated and restored with a preformed crown in a single~     session, and then closely followed-up for 1, 3, 6, 12, 18, and 24 months.~   "
19658|NCT02799914|"~     Post market clinical follow-up study about the Sinus-venous stent. Patients with venous~     iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational~     study will provide 1 year data about safety and efficacy.~   "
19659|NCT02799901|"~     Combining nivolumab with conventional multisite high dose radiotherapy seems to be an~     interesting approach that could increase the antitumoral effect of nivolumab by increasing~     the diversity and quantity of tumoral antigen presentation thanks to radiotherapy.~     Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also~     increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire~     of intratumoral T cells.~      The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis~     for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other).~      The investigators hypothesize that combining nivolumab with multisite, multifractionated HR~     increases the overall survival rate at 1 year compared to published data with nivolumab~     alone.~   "
19660|NCT02799888|"~     HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor)~     hematopoietic stem cell transplantation (HSCT) is associated with increased~     graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5)~     antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control~     as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this~     study is to evaluate the safety and efficacy of maraviroc combined with standard~     graft-versus-host-disease prophylaxis in patients with hematologic malignancies after~     allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors.~     Based on the results of our previously small sample study with maraviroc combined with~     cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to~     perform the clinical trail.~   "
19661|NCT02799875|"~     Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain~     ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of~     either a higher level of permissive hypercapnia or of a lower level of permissive~     hypercapnia to determine if either strategy will increase the number of alive~     ventilator-free days in the 28 days after randomization.~   "
19662|NCT02799862|"~     This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety~     and quality of life (QoL) in patients with advanced NSCLC receiving the combination of~     nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.~   "
19663|NCT02799849|"~     A significant weight gain and obesity are observed for most patients with narcolepsy, mainly~     at the beginning of the disease and narcolepsy in young children. There is no specific study~     on the population and the consequences of overweight in the lives of these long-term~     patients. Narcoleptic patients gain weight significantly at the onset of their illness. It~     is also known that weight gain is not related to the treatment of narcolepsy. The etiology~     of obesity in narcoleptic patients is not established. Several assumptions were made~     (physical activity, leptin diet, metabolism). The reason and the pathophysiology of~     overweight and obesity in this population therefore remain unclear.~      In this study, potential change in the total metabolism (24h) for narcoleptic children that~     could explain their tendency to obesity will be assessed ?~   "
19679|NCT02799641|"~     Does the addition of cervical lidocaine injections and valium to the current practice result~     in decreased reported pain with tenaculum placement, IUD insertion, and post procedural~     discomfort? The current practice is ibuprofen alone or no medication.~   "
19736|NCT02798874|"~     The 'no-reflow' phenomenon after a percutaneous coronary intervention (PCI) in patients with~     acute ST-segment elevation myocardial infarction (STEMI) is a strong predictor of both~     short- and long-term mortality. Faster antiplatelet activity and increased levels of~     adenosine provide a theoretical basis for ticagrelor to effectively prevent no-reflow after~     PCI. We planned to evaluate the effects of ticagrelor on myocardial no-reflow after PCI for~     STEMI.~   "
19664|NCT02799836|"~     Amblyopia is a significant health problem, affecting up to 4% of the population in the~     United States. Amblyopia, commonly known as lazy eye, is a developmental visual disorder~     in which one or both eyes suffer from poor vision as a result of being disadvantaged in~     early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering~     eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most~     common causes of amblyopia. If conventional treatment, such as patching the better seeing~     eye, is not initiated during the critical period of visual development, lasting visual~     impairment may persist throughout life. This critical period of visual development has been~     thought to end around age 10. However, recent research has demonstrated that the critical~     period of visual development can be extended into adulthood. Complete light deprivation in~     animal models has restored plasticity in the visual cortex and has demonstrated drastic~     recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the~     impact of complete light deprivation on visual function in a cohort of human adults with~     severe amblyopia from anisometropia.~   "
19665|NCT02799823|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
19666|NCT02799810|"~     In a prospective longitudinal cohort study we aim at investigating the extent to which~     pre-transplant psychosocial levels of functioning predict the medical and psychosocial~     outcomes of lung transplantation. There is evidence that e.g. persistently elevated~     depressive symptoms are associated with reduced survival after lung transplantation~   "
19667|NCT02799797|"~     This study compares the long-axis and short-axis technique of continues adductor canal block~     for total knee replacement surgery. Half participants will receive long-axis~     catheterization, while the other half will receive short-axis catheterization.~   "
19668|NCT02799784|"~     The primary objective of this study is to assess the effect of umeclidinium/vilanterol~     (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD.~      This is a multicentre, randomized, open label, 2 period crossover complete block design~     study.~      Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a~     sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram [mcg] once-daily [QD])~     administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray~     administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be~     followed by a 3-week washout period and one-week follow-up period. The total duration of~     subject participation in the study will be approximately 22 weeks.~      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a~     registered trademark of Boehringer Ingelheim.~   "
19669|NCT02799771|"~     HYPID-2 study is an extension of HYPID study (NCT01443598) :~      HYPID-2 is also an observational and prospective study of patients with interstitial lung~     disease and pre capillary hypertension diagnosed by right heart sided catheterization.~      It concerns only incident patients (i.e patients included within 6 months after PH~     diagnosis) whereas HYPID concerned prevalent and incident cases.~      The primary aim is the same than HYPID : identify prognostic factors~   "
19670|NCT02799758|"~     The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily~     compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol~     (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo®~     IR 4 mg daily after long-term treatment~   "
19671|NCT02799745|"~     The primary purpose of this study is to compare the time to prostate cancer progression~     (pathological or therapeutic progression) between patients treated with enzalutamide versus~     patients undergoing active surveillance.~   "
19672|NCT02799732|"~     This feasibility study was developed to evaluate the proposed approaches for enrollment,~     sample collection, interview and retention over a six-month vaccination period for the~     clinical trial: A scientific evaluation of one and two doses of the bivalent and nonavalent~     prophylactic HPV vaccines (1DT) currently under development . These aspects will be~     assessed quantitatively and qualitatively by measuring the efforts needed to identify and~     recruit each study participant, the participation rate for the study, and the retention rate~     at six months, as well as collecting information on the acceptability of study procedures.~     To supplement the assessment of the acceptability of the self-collected swab among older~     girls, a parallel effort will be done at the end of this feasibility study. Combined, this~     feasibility work will allow for modifications to the design, approaches and methods of the~     new trial.~   "
19673|NCT02799719|"~     Overweight and obesity have become an increasing problem in patients on hemodialysis.~     However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis~     patients , using body mass index(BMI) as metric fat mass is associated inversely with death~     rate. Nevertheless, it is questionable that obesity can be considered an unequivocal~     protective factor in chronic diseases as increase body fat mass appears to be a potential~     cause of the chronic inflammation frequently present in these patients. The consequences of~     this inflammation are impaired nutritional status, accelerated atherosclerosis, and~     increased mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA)~     and bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes~     in an observational cohort of hemodialysis patients. Besides, we aim to assess the~     relationship between body fat composition, clinical metabolic risk profiles, measures of~     adiposity, such as waist circumference (WC), visceral adiposity index, waist-to-hip ratio~     (WHR), and waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these~     maintenance hemodialysis patients.~   "
19674|NCT02799706|"~     The primary objective of the trial is to assess if GnRH antagonists in combination with~     external beam radiation therapy improve progression free survival (progression that can be~     biological, clinical, or death) compared to GnRH agonists in combination with external beam~     radiation therapy.~      Secondary objectives include:~        -  documentation of effect of GnRH antagonists on clinically significant cardiovascular~          events in the subgroup of patients at high risk of such events at baseline;~        -  documentation of side effects and quality of life, I-PSS and urinary tract infections;~        -  assessment of relative treatment effect on secondary efficacy endpoints (clinical~          progression, time to next line of systemic therapy, time on therapy, overall and cancer~          specific survival) and on PSA at 6 months after end of RT.~   "
19680|NCT02799628|"~     The trust between patients and medical providers is the cornerstone to obtain success~     treatment. To boost the trust can increase medical prescription compliance, enhance patient~     satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between~     medical providers and patients will result in ineffective treatment and excessive defensive~     health care. This situation may cause medical dispute and medical resources wasting~     problems.~      Most of treatment complete in a few times of admissions and interventions. So, how to~     improve the trust between patients and doctors quickly became a more knotty problem. Several~     studies found that speech (including listening, showing compassion, and take longer to~     explain), reputation, clothing, offer a newer therapy were more important than age, title,~     and sex.~      However, past researches were restricted to an unclear causal relationship. That is they~     can't be determined whether good doctor-patient relationship and better trust conditions~     create a longer visit time, better satisfaction, and good reputation, or vice versa. They~     also unable to clarify whether the high degree of trust result in improved treatment~     effects, or good relationship result from good medical outcomes.~      Investigators want to design a randomized control trial by giving patients recommendation~     and physical therapist introductions to enhance the trust of patients to therapists. And~     this study may verify whether enhance trust between therapists and patients will lead to~     changes in treatment effectiveness.~   "
19681|NCT02799615|"~     This multicenter study is being conducted to determine whether infliximab exposure after an~     initial infusion is predictive of early clinical response in hospitalized pediatric patients~     with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish~     the infrastructure, demonstrate feasibility, and collect preliminary data to support the~     full study.~   "
19682|NCT02799602|"~     The purpose of the study is to assess the efficacy and safety of BAY1841788 (ODM-201) in~     combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with~     metastatic hormone sensitive prostate cancer.~   "
19683|NCT02799589|"~     This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in~     combination with a caudal block for patients ages 1 year to 3 years old receiving elective~     surgery to investigate alternatives to the currently used volatile anesthetics.~   "
19684|NCT02799576|"~     The investigators hypothesized that using the curved needle could facilitate the block~     placement and provide short procedure time. Aim of the work: The investigators will compare~     namely straight and curved block needle with in-plane needle insertion techniques for the~     infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.~   "
19685|NCT02799563|"~     A 2-by-2 factorial cluster randomized controlled trial was performed to: 1) Compare the~     effects of supervised (coached) versus unsupervised (no coach) administration of the DKA~     simulator on trainees' knowledge of DKA management immediately after (primary outcome) using~     the simulation and 3 and 6 months post-intervention (secondary outcome); 2) Determine~     whether a preselected number of DKA simulator practice cases or a self-selected number~     (self-regulated learning) of DKA simulator practice cases will result in superior trainee~     knowledge with respect to DKA management immediately after (primary outcome) and 3 and 6~     months post-intervention (secondary outcome).~   "
19686|NCT02799550|"~     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of~     differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19)~     infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)~   "
19687|NCT02799537|"~     Our goal is to compare two types of advance directives forms available in English and~     Spanish to determine which is more easy to use for patients.~   "
19688|NCT02799524|"~     The objective of this study is to evaluate the scales commonly used in geriatrics and~     oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress~     ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14~     questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).~      The prospective observational study will be conducted in parallel on two sites ( University~     Hospital Centre and François Baclesse ) after informed patient information.~      It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer~     or haematological malignancies in the hospital to meet the mood disorder screening~     questionnaires .~   "
19689|NCT02799511|"~     A transient ischemic attack (TIA) should be considered an emergency prevention opportunity~     in order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling).~     Indeed, about 20% of patients who have IC had in previous days or weeks, a TIA, which can be~     defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain~     damage and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are~     AIT. Despite the progress achieved in the treatment in the acute phase of an IC, prevention~     remains the most effective way to fight against this disease. This prevention can be put in~     place before the occurrence of a first IC, or after a first IC, especially when minor as a~     TIA.~      However, the diagnosis of TIA remains particularly difficult and it is necessary now to~     identify new tools for the diagnosis of transient ischemic attack. Our study focused on the~     identification of one or more molecules (called biological markers or biomarkers) present in~     the bloodstream of patients, which will serve to facilitate the differential diagnosis of~     patients with TIA.~   "
19690|NCT02799498|"~     The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is~     administered to healthy subjects aged 18-55 by an auto-injector device and manual injection~     (each subject received both injections).~   "
19691|NCT02799485|"~     This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating~     patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of~     blood vessels that provide blood to the cancer, and may also prevent cancer cells from~     growing.~   "
19720|NCT02799082|"~     The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used~     with photodynamic therapy (PDT) in patients suffering from actinic keratosis.~   "
19721|NCT02799069|"~     The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the~     treatment of actinic keratosis with photodynamic therapy (PDT) compared to Metvix.~   "
19722|NCT02799056|"~     The primary objective is to assess whether the fraction of diaphragmatic shortening in~     combination with the presence / absence of alveolar-interstitial syndrome evaluated through~     chest ultrasound may predict successful extubation in adult patients hospitalized in the~     intensive care unit.~   "
19692|NCT02799472|"~     This study is designed to explore the activity of granulocyte-macrophage colony stimulating~     factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential~     impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any~     differences in the GM-CSF axis between subjects with early RA compared with those with more~     established disease. This study also aims to establish the potential impact of GSK3196165 on~     inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging~     (MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled~     parallel group study. Approximately 40 subjects with active RA despite treatment with~     disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be~     randomized into the study, following a screening period of up to 6 weeks. The total~     treatment period is up to 10 weeks, with a 12-week follow-up period after the last dose~     (Week 22).~   "
19693|NCT02799459|"~     Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in~     Anesthesia's field.~      This study wants to prove that the Hypnosis in conization are cheaper.~   "
19694|NCT02799446|"~     The purpose of this study is to determine whether Reslizumab is effective for the treatment~     of chronic sinusitis.~   "
19695|NCT02799433|"~     This randomized controlled trial uses administrative public health screening data to test~     whether the Healthy Apple program (HAP), designed to support local implementation of~     national Let's Move! Child Care guidelines in San Francisco (SF), improves child care center~     nutrition and physical activity practices and child weight change.~   "
19696|NCT02799420|"~     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure~     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for~     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or~     less. Recently, confocal laser endomicroscopy has been introduced for real-time~     histopathologic diagnosis in various cancers. In previous pilot study in our institution,~     pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in~     biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with~     undifferentiated histology. However, there was a limitation because of small sample size.~     Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser~     endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer~     cells and expression ratio of tumor marker in biopsy samples.~   "
19697|NCT02799407|"~     The purpose of this study is to compare the modular, multi-tiered consent process featured~     in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to~     determine whether participants using the ResearchKit consent form have a significantly~     higher comprehension of the elements of consent than participants using the standard consent~     form.~   "
19698|NCT02799394|"~     The purpose of this study is to investigate the effect of activity modification, exercises~     and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The~     primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary~     endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The~     adolescents will be recruited from primary schools, general practitioners and through online~     advertising on Facebook.~   "
19699|NCT02799381|"~     The primary objective of this study is to examine the effect of levodopa-carbidopa~     intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in~     participants with advanced Parkinson's disease (PD).~   "
19700|NCT02799368|"~     As iodinate contrast media (CM) has been widely used in current medical practice, contrast~     induced acute kidney injury (CI-AKI) has been an important issue.~      Previously, many guidelines suggested prophylaxis protocol using 0.9% saline when CM is~     administrated to high risk patients. However, recent studies showed that 0.9% saline might~     induce metabolic acidosis due to its supra-physiologic chloride component, and therefore~     renal vasoconstriction. In spite of protective effect by volume expansion with saline~     infusion, this renal vasoconstriction might have conflicting effect on renal function, as~     hypoxic injury is suspected to be the main cause of CI-AKI.~      In contrast to 0.9% saline, balanced salt solution has physiologic level of chloride and~     neutral pH. Also, recent studies proved preventive effect of balanced salt solution for AKI~     in several clinical settings.~      Hence, the investigators planned a prospective randomized controlled trial comparing 0.9%~     saline and balanced salt solution to prevent CI-AKI.~   "
19701|NCT02799355|"~     Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for~     approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account~     for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to~     receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in~     the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents,~     daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 -~     100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks.~     Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based~     ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development~     of agents that directly target various stages of HCV replication are likely to provide~     HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is~     associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis,~     and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2~     infection.Moreover, patients with HCV genotype 3 infection are less responsive to~     peginterferon based treatment than are patients with HCV genotype 2 infection.~   "
19702|NCT02799316|"~     Hepatitis B virus (HBV) infection is a challenging health problem. According to the World~     Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV~     infection worldwide.~      After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface~     antigen (HBsAg) had generally been believed to signify viral elimination. However, it now~     becomes clear that those subjects may have occult HBV infection which is defined as the~     presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection~     usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody~     against HBsAg (anti-HBs), but some cases might not have these serological markers~     (seronegative occult HBV infection) .~   "
20008|NCT02795299|"~     Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate~     Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.~   "
19703|NCT02799303|"~     In this open randomized controlled trial, we seek to study whether prostate cancer screening~     using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection~     rate of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate~     biopsy) compared with prostate cancer screening using prostate-specific antigen (PSA).~      The current paradigm of prostate cancer screening relies upon an initial PSA blood test,~     with subsequent investigations driven by the serum PSA level. This model has proven highly~     controversial due to the inability of PSA level to discern between indolent and aggressive~     forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended~     against PSA screening. Evidence suggests that prostate cancer screening has led to an~     increased proportion of men being diagnosed with potentially curable prostate cancer.~     However, due to the inability of the PSA level to accurately distinguish patients with~     indolent and lethal forms of prostate cancer, it has led to a significant rate of~     over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an~     increasingly large role in the management of patients with clinically-localized prostate~     cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on~     active surveillance and staging prior to definitive interventions. MRI-based prostate cancer~     risk assessment has been shown to better distinguish between clinically-significant and~     insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based~     prostate cancer screening and PSA-based prostate cancer screening is warranted.~   "
19704|NCT02799290|"~     Adipose Tissue Extract (ATE) has been found to be an antologous source of growth factors~     with proven in vitro angiogenic and adipogenic properties.It is obtained by a simple~     lipoaspiration procedure. We sought to compare the effect of ATE with another known source,~     platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.~   "
19705|NCT02799277|"~     The main goal of this project to investigate the psychological processes underlying moral~     judgments in social dilemmas. WE will examine neuroendocrine determinants of moral judgment~     by investigating the effects of exogenous testosterone~   "
19706|NCT02799264|"~     Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1~     infection. Specifically, it is being developed as a component of a 2-drug maintenance~     regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine~     requires food for optimal absorption; therefore the recommended intake of cabotegravir in~     the planned Phase 3 treatment studies is with food regardless of fat or calorie content,~     when administered along with rilpivirine. This is a single-center, randomized, open-label,~     two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on~     the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled~     in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of~     fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A').~     The remaining 12 subjects will receive a single dose of cabotegravir orally along with high~     fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be~     switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All~     the subjects will be followed up to 30 days from the day of receiving first dose of~     cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of~     cabotegravir.~   "
19707|NCT02799251|"~     Postoperative infections are one of the most common complications in thoracic and digestive~     cancer surgery. Former studies have demonstrated that inflammatory response is altered~     during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may~     contribute to postoperative infection. To date, no one has proved it in a multivariate~     analysis. The aim of this study is to determine if lymphopenia is associated with~     postoperative infections in thoracic and digestive cancer surgery.~   "
19708|NCT02799238|"~     This is a randomised, open-label, multi-centre, Phase II study in patients with newly~     diagnosed glioblastoma.~      Up to 87 patients with newly diagnosed glioblastoma will be enrolled in the study in a 1:2~     allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).~      Data from a further 29 patients gathered from an ongoing observational study of glioblastoma~     patients treated according to SOC at Sahlgrenska University hospital in Göteborg, Sweden~     will be used as historical control data and combined with the randomised control data in~     performing the statistical analysis.~      Patients recruited into this study will receive either:~        -  ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma~          (first line therapy: Stupp regimen, followed by second line therapy at the~          Investigator's discretion) or~        -  Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp~          regimen, followed by second line therapy at the Investigator's discretion).~   "
19709|NCT02799225|"~     Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora.~     These micro-organisms are frequently responsible for nosocomial or community-acquired~     infections, for which treatment is essentially based on the use of beta-lactam antibiotics.~     This class of antibiotics comprises penicillins, cephalosporins, monobactams and~     carbapenems. Carbapenems have the advantage of possessing a broad antibacterial spectrum and~     the capacity to resist the hydrolytic action of a large number of beta-lactamases,~     widespread inactivating enzymes.~      However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either~     alone or in combination with additional resistance mechanisms such as loss of membrane~     permeability or overexpression of efflux systems, are currently emerging all over the world.~     Carbapenemases represent a major public health problem because of the risk of therapeutic~     impasse and their high epidemic potential.~   "
19710|NCT02799212|"~     Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from~     underlying liver disease and are exposed to the risk of postoperative ascites, with~     subsequent morbidity, liver and renal failure, the need for specific treatments and~     prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal~     venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive~     method for modulating the portal inflow would be of interest: it could be used temporarily~     during the early postoperative course to prevent acute portal hypertension. Somatostatin, a~     well-known drug already used in several indications, may limit the risk of postoperative~     ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in~     patients with underlying liver disease.~   "
19711|NCT02799199|"~     Objectives: This study describes efficacy and safety of Fingolimod in patients treated for~     at least 6 months in the east of France from January 2011 to December 2014.~      Background: The Grand-Est is a geographical region in France with a high prevalence of~     multiple sclerosis (more than 10000 patients registered in the European Database for~     Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014~     patients have been treated for at least 6 months with Fingolimod, the first oral therapy for~     patient with very active relapsing-remitting MS.~      Methods: Features of patients followed up in the Grand-Est region and treated with~     fingolimod in the 6 university hospitals, general hospitals and private neurologists were~     reviewed in a retrospective study after identification of the clinical files reported in the~     EDMUS database.~   "
19712|NCT02799186|"~     Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of~     Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular~     risk factors. The origin of SCAD remains uncertain but a strong and frequent association~     with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence~     only.~      The aim of our study is to assess the presence of FMD and its genetic determinants i in a~     sample for haematoma or spontaneous coronary artery dissection.~      From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients~     admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than~     30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging~     data will be reviewed by two experienced interventional cardiologist experts in SCAD~     diagnosis.~      For each patient a genetic analysis will be performed. A systematic screening for FMD will~     be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac~     arteries and reviewed by two experienced radiologists. A one year follow-up is expected.~      This study aims to confirm the presumed association of FMD and SCAD through the exploration~     of several artery beds and the study of confirmed genetic determinants, which has never been~     described previously to our knowledge.~   "
19713|NCT02799173|"~     Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of~     osteoporosis and cardiovascular calcification. It has also been suggested that bone~     remodelling and cardiovascular calcification are regulated by the same mechanisms, but~     inversely in terms of calcium deposition, as osteoporosis is often associated with~     cardiovascular calcification. Inflammatory and immune factors have been implicated in these~     two processes.~      The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the~     last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts,~     while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of~     smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this~     phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the~     role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly~     established, its role in vascular calcification is only hypothetical at the present time.~      This study will focus on patients with SLE diagnosed and followed in the Amiens University~     Hospital Internal Medicine and Nephrology departments~   "
19714|NCT02799160|"~     This observational study evaluates the clinical, biochemical and haemodynamic effects of~     large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation~   "
19715|NCT02799147|"~     Our and other groups have demonstrated very low incidence of acute and chronic~     graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in~     haploidentical, unrelated and related allogeneic stem cell transplantation (SCT).~     Nonetheless for majority of the grafts, except for 10/10 HLA-matched bone marrow, with this~     type of prophylaxis require concomitant administration of calcineurin inhibitors±MMF, which~     delays immune reconstitution and development of graft-versus-leukemia (GVL) effect. So,~     despite reduction of transplant-related mortality, use of PTCy doesn't lead to the reduction~     of relapse incidence. This is particularly important for relapsed or refractory acute~     leukemia patients, where, despite all efforts to intensify conditioning regimens, relapses~     after SCT occur in more than 50% of patients, and long-term survival rarely exceeds 10-20%.~     In preclinical model of haploidentical SCT the substitution of post-transplantation~     cyclophosphamide with bendamustine, led to comparable GVHD control, but significantly~     augmented GVL effect. To test this hypothesis and improve the outcome of allogeneic SCT in~     refractory acute leukemia patients we initiated a pilot trial with high-dose~     post-transplantation bendamustine for GVHD prophylaxis. The selection of doses is based on~     the previous dose-escalation studies. No additional immunosuppression is planned for this~     trial.~   "
19716|NCT02799134|"~     CAR is short for cortisol awakening response. The neural mechanism of CAR effect on~     high-order cognition and social cognition is less known...~   "
19717|NCT02799121|"~     This prospective case series is to gain additional clinical experience in the treatment of~     diabetic foot ulcers, by documenting and relating patient history (including baseline wound~     characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient~     and physician satisfaction) in a group of study participants for whom the ReGenerCell™~     Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional~     therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive~     ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings,~     offloading).~   "
19718|NCT02799108|"~     Recent data published by various laboratories as well as our preliminary data tend to prove~     that near-infrared spectroscopy can be used to determine the lateralization of language as~     part of the preoperative assessment for drug-resistant epilepsy. The reference test used up~     until very recently was the Wada test, which consisted of injecting an anaesthetic~     (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in~     order to determine the predominant cerebral hemisphere for language. This invasive test has~     been progressively replaced by fMRI, which is nevertheless difficult to perform in children~     under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in~     contrast with fMRI, can be easily repeated and allows simple investigation of the various~     facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have~     acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the~     development of language structures.~   "
19719|NCT02799095|"~     To better understand the safety and tolerability of ALKS 4230 in humans~   "
19726|NCT02799004|"~     Pain is one of the most common complaints in emergency department (ED) and is still often~     poorly managed. A major prospective multicenter study reported that 74% of patients that had~     a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly,~     physicians frequently prescribed analgesic after discharged for these patients, and opioid~     is given in 29% of ED visits involving pain complaints. However, few studies evaluate pain~     management after ED discharge: the frequency and length of opioids prescriptions, the~     opioids quantity taken by the patients, are the patients relieved and satisfied by these~     pain treatments, what are the adverse effects associated with the use of these medications,~     and what are the chances of developing addiction?~      The primary aim of this study is to determine the required minimal opioids prescription for~     patients treated for acute pain after being discharge from the ED. Secondary objectives~     include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the~     patients' level of pain relief associated with their respective opioids treatment; 3)~     determine the patients' level of addiction following post-ED opioids treatments.~      The design of the project is a prospective observational cohort study. A cohort of~     consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and~     discharged from the ED in less than 48 hours with a prescription of opioid will be asked to~     participate in the study. Patients will be excluded if there is ongoing treatment for a~     pre-existing chronic pain condition or if they used opioid drugs in the past year. Research~     nurses will contact the patients by phone at three follow-up time points (1 week, 1 month,~     and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain~     treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids~     addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses~     will also question the patients about their daily opioids usage and if they were relieved~     from pain.~      This study will provide the base for future guidelines regarding the prescription of opioids~     treatment for specific pathology encountered in ED. It will also give indications on how to~     adjust the treatments according to adverse events and the level of addiction experienced by~     patients.~   "
19727|NCT02798991|"~     The current study is designed to assess the safety, tolerability, pharmacokinetics (PK),~     gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses~     of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized,~     double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be~     randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.~   "
19728|NCT02798978|"~     This study is an ascending dose first-time-in-human study to determine the safety,~     tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in~     healthy subjects. The results will support the design of future clinical trials of~     GSK1795091 administered to subjects with advanced malignancies in combination with immune~     system modulators.~      Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single~     center, single dose escalation, sequential group evaluation of intravenously administered~     GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an~     open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week~     apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects~     will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total~     duration of this study is approximately 10 weeks from screening to the last study visit.~   "
19729|NCT02798965|"~     Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young~     women. Although the aetiology and pathogenesis remain obscure, the most widely accepted~     hypothesis is an interaction between a genetic predisposition and an environmental trigger~     factor such as viral infection. Parvovirus infections have been proposed as trigger factors~     for Hashimoto's thyroiditis and Graves' disease.~   "
19730|NCT02798952|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the~     first two years of life and to assess the anamnestic response, immunogenicity, safety and~     reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.~   "
19731|NCT02798939|"~     Bacterial infections are a major cause of mortality in cirrhotic patients in the context of~     gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP~     is therefore an important research goal because the gold standard neutrophil count in~     ascitic fluid cannot be performed 24 hours a day in all healthcare structures. The use of~     urine dipsticks in ascites cannot be recommended at the present time due to their~     insufficient sensitivity with an unacceptable risk of false-negatives in the context of a~     fatal disease for which effective antibiotic therapy is available. Ascitic fluid lactoferrin~     assay has recently been demonstrated to be a very good diagnostic test for SBP. The~     investigators plan to conduct a prospective study on lactoferrin as well as procalcitonin~     (PCT) to determine the best laboratory test(s) for the rapid, automated diagnosis of SBP.~     These tests will be compared with the Aution® urine dipstick, which has been shown to~     present better diagnostic sensitivity than the Multistix® dipstick . This single-centre~     study (Amiens University Hospital) will be performed in the context of routine clinical~     practice on ascitic fluid that is usually incinerated.~   "
19732|NCT02798926|"~     Particular attention is paid to thermal management of preterm neonates in neonatal intensive~     care units because of the major risk of morbidity associated with hypothermia. Percutaneous~     central venous catheter placement is essential to ensure adequate caloric intake and~     intravenous administration of treatments, but this procedure can cause major body~     temperature variations, responsible for complications in these neonates, as convection~     incubator function is impaired during opening of the incubator, which can be prolonged (30~     minutes to 2 hours) depending on the technical difficulties encountered during catheter~     placement.~      In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal~     transport is now clearly defined and ensures stability or even a considerable temperature~     gain during transfer immediately after birth. In the light of several clinical cases, the~     use of a polyethylene bag during central venous catheter placement appears to be effective~     to prevent body temperature loss in preterm neonates. No data are currently available~     concerning the value of this method of prevention of hypothermia during this type of~     procedure.~      Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or~     sheet could be useful during this procedure by significantly reducing heat loss caused by~     convection and evaporation. However, compensation phenomena such as generalized~     vasoconstriction to cold in preterm infants are very poorly described, but can induce a~     functional conflict between mechanisms ensuring maintenance of homeostasis and those~     involved in maintenance of blood pressure.~   "
19733|NCT02798913|"~     The objective of the present study was to evaluate the prognostic impact of prolonged dual~     antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of~     major adverse cardiovascular events and major adverse limb events after percutaneous lower~     extremity revascularization in patients with lower extremity peripheral arterial disease~     (LE-PAD).~   "
19734|NCT02798900|"~     The aim of this study is to evaluate the effect of a functional task-training program~     combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality~     in adults with hip osteoarthritis.~   "
19737|NCT02798861|"~     The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis~     using liver biopsies as reference. Secondarily, investigators will correlate transient~     elastography (TE) and CAP results, analyze possible associations between CAP/TE and~     post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The~     study aims to include as many donors as needed to achieve 100 transplanted liver allografts.~   "
19738|NCT02798848|"~     This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of~     assistive technologies for children/young people with low vision/blindness. The~     investigators will recruit 40 students age 10-18 years in India and the UK, who will be~     randomised into two groups. Apple iPads will be the active intervention; the control arm~     will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage~     and accessibility of the device and trial feasibility measures. Exploratory outcomes will be~     validated measures of vision-related quality of life for children/young people as well as~     validated measures of reading and educational outcomes. In addition, the investigators will~     carry out semistructured interviews with the participants and their teachers, and attempt to~     evaluate cost-effectiveness.~   "
19739|NCT02798835|"~     This study evaluates the difference between adductor canal blocks, with or without~     intravenous dexamethasone administered, and continuous adductor canal infusions for patients~     having total knee arthroplasties, ascertaining the decrease in opioid consumption. It's a~     three arm study, with a third of patients receiving a single shot adductor canal block, a~     third receiving single shot plus intravenous dexamethasone and the rest a continuous~     adductor canal local anesthetic infusion.~   "
19740|NCT02798822|"~     Posterior crossbite is a common clinical condition often associated with transverse~     maxillary deficiency and functional mandibular shift. This frequent malocclusion is not~     self-correcting and can lead to the development of craniofacial asymmetries and mandibular~     dysfunction.~      The aim of the current study was to evaluate maxillary and mandibular arch widths' response~     to RME when it is anchored to the upper second deciduous molars or to the upper first~     permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition~     patients.~   "
19741|NCT02798809|"~     The aim of the study is to follow a group of preschool children from early permanent~     dentition to determine the prevalence and incidence of caries malocclusions and to~     investigated the related risk factors as age, gender, ethnic origin and non-nutritive~     sucking habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and~     dental care.~   "
19742|NCT02798796|"~     The aim of this study is to evaluate the ability of MRI to select patients for conservative~     treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages~     I, II and III candidates for conservative surgery will be randomly randomized to do MRI or~     not according mammary density.~   "
19743|NCT02798783|"~     People with the congenital anatomical malformation known as Enlarged Vestibular Aqueduct~     (EVA) may experience decline in hearing ability. This is an online registry to gather~     patient experiences with EVA, with the goal of providing future researchers with the~     information necessary to better evaluate and make recommendations for patients with EVA.~     Data will be obtained from volunteers who enroll and submit their information on a website,~     https://eva.uhhospitals.org, and a limited data set may be provided to researchers~     interested in analyzing repository data. The limited data set would not contain any~     identifiable information except for ages, dates such as date of diagnosis, or city/state of~     residence.~      EVA Research Project Website: http://rainbow.org/EVAResearch~      EVA Patient Registry Website: https://eva.uhhospitals.org~   "
19744|NCT02798770|"~     Ischemic stroke is the leading cause of acquired disability among adults, and one of the~     main causes of death. In Switzerland, the approved time window for stroke treatment with~     intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window,~     however, the benefit of treatment strongly decreases as time passes.~      Moreover, only around 10% patients receive thrombolytic treatment, since patients with~     stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the~     community on the symptom of stroke, prehospital delay did not decrease over time, and the~     reasons remain incompletely understood. Prehospital delay reduces the proportion of patients~     with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome~     among the minority treated with thrombolysis.~      This prospective cohort study aims at understanding the causes of prehospital delay among~     patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside,~     patients and proxies along a standardized questionnaire on prehospital delay. Avoiding~     modificables causes of prehospital delay may increase the thrombolysis rate and improve~     outcomes after stroke.~   "
19745|NCT02798757|"~     This is a phase IV study that will explore the mechanisms of action of a drug~     (dapagliflozin) that is already commercially available in the country where the study will~     be conducted (Greece). The drug will be used according to its approved clinical indications~     (as add-on treatment in patients failed to achieve glycemic targets on metformin~     monotherapy) and in the approved posology (10 mg/day). Additionally, although there is~     limited data on the coadministration of dapagliflozin with thiazides, the excellent safety~     profile of the drug even when it is used in combination with drugs that induce significant~     volume depletion (such as loop diuretics) suggests that, in properly selected patients, the~     possibility of important adverse events during the coadministration of dapagliflozin with~     chlorthalidone is very low. All patients will give written informed consent prior to their~     enrollment in the study. The study protocol will be approved by the scientific committee of~     the University Hospital of Ioannina.~   "
19757|NCT02798601|"~     The purpose of this study is to estimate the effect of an early induced hypernatremia~     protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145~     milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain~     injury managed at critical care unit.~   "
19758|NCT02798588|"~     In last decades, several advances in the neuro-intensive management have lead to decrease~     mortality in Intensive Care Units. A significant morbidity remains as patients survive after~     a traumatic coma with uncertain quality of awakening and a high risk of functional~     disability. Predicting awareness recovery and functional disability of those who will awake~     constitutes a major challenge to inform patients' relatives, to give the best chances in~     terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools~     currently available are not sufficient neither to predict bad awakening outcome nor to~     predict good functional outcome. In many countries, life's support cessation is a constant~     call for robust evaluation as soon as possible in ICU but it is mandatory to reach a~     positive predictive value of non-awaking close to 100%. Many clinical,~     electro-physiological, biological, radiological and functional parameters have been~     conducted with comatose patients assuming the purpose to predict outcome. Regarding~     unfavourable outcome, the gold standard is the abolition of the N20 component of~     somatosensory evoked potentials but the specificity is high enough only for patients with~     anoxic coma. Several neurophysiological markers such as MMN, P300 are correlated to a~     favourable outcome but the sensitivity and specificity remains low for patients who suffered~     a severe traumatic brain injury. New Diffusion Tensor imaging sequences provide~     complementary information to detect small structural lesions (diffuse axonal lesions).~     Recently, functional MRI analyzing Resting State has also been proposed as a prognostic~     marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the metabolism in key~     regions of the awakening network in either anaesthesia or sleep. Recent studies have~     reported interesting results at the chronic stage but to knowledge, these tools have only~     been used to address pathophysiology's issues and never to improve coma prognosis at the~     initial stage. The investigators hypothesize that the heterogeneity of the population~     requires a global and accurate assessment of the central nervous system, combining~     structural, metabolic and functional information in order to refine the prognosis.~      The protocol integrates in one-sequence most radiological markers of brain injury within a~     unique PET-MRI in Lyon. The most relevant originality of the study consists in confronting~     FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery.~     The added clinical value would be to question the synergistic effect of each parameter and~     to find out which ones are the most useful for awakening prediction, as they have not been~     compared in a multi-parametric database.~      PET-MRI, as a new device combining physiological and prognostic questioning, allows us:~        -  to implement a more integrative physio-pathological analysis~        -  to avoid the cofounding effect of awareness' fluctuations in recording simultaneously~          multiple functional imaging techniques.~      The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity,~     related to neuronal activity (glucose metabolism) and brain perfusion.~   "
19795|NCT02798107|"~     Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with~     very high affinity. Idarucizumab potently and specifically binds to dabigatran and its~     metabolites and neutralises its anticoagulant effect. A clinical development program is~     ongoing to support marketing authorisation submissions for idarucizumab indicated in~     patients treated with dabigatran who require emergency surgery/urgent procedures or who have~     a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects~     of dabigatran is required.~   "
19746|NCT02798744|"~     The aim of this study is to investigate the cause for the discrepancy in predicted and~     observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation.~      Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on~     energy expenditure and change in total body weight and body composition.~      The primary outcome is change in appetite hormone concentrations (specifically total PYY)~     between baseline and 24 weeks: - this will be measured by sequential blood sampling during~     visits 1-5.~      Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and~     GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy~     expenditure, appetite perception, physical activity and blood and urine biochemical~     parameters after Empagliflozin (Jardiance™) treatment for 24 weeks.~      The sample size for the study is 76 participants and the planned trial duration is 21~     months, with participants receiving approximately 24 weeks of exposure to Empagliflozin~     (Jardiance™).~   "
19747|NCT02798731|"~     The aim of the study is to evaluate the impact of early microvascular disease assessed by~     coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve~     (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft~     vasculopathy (CAV) in heart transplant recipients.~   "
19748|NCT02798718|"~     Milk is the source of high-quality protein, calcium, and other vitamins and minerals.~     Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome,~     T2DM, hypertension and obesity, which are independent risk factors of cardiovascular~     disease. However, milk contains disaccharide lactose, which may cause gastrointestinal~     problems in those adults with poor digestion. Recent studies have shown that subjects with~     intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of~     12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant.~     Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption~     to it. Lactose maldigestion would not be a restricting factor in milk intake. In general,~     the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide,~     and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have~     beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may~     change the intestinal flora profile. But there are few studies evaluating effect of milk~     intake on health of people with lactose malabsorption or intolerance.This trial intend to~     study the effect of whole milk on cardio-metabolic risk factors of healthy person with or~     without lactose maldigestion.~   "
19749|NCT02798705|"~     The aim of the study is to evaluate coronary flow reserve (CFR), index of microcirculatory~     resistance (IMR), and proportion of overt microvascular disease, defined as depressed CFR as~     well as elevated IMR in patients with cardiac amyloidosis. The second objective of this~     study is to compare results of non-invasive test including serum light chain amount, Doppler~     echocardiography with 2D strain, and cardiac perfusion MRI.~   "
19750|NCT02798692|"~     The objectives of this first-in-human is to evaluate the safety and the immunogenicity of~     three administrations of a bivalent vaccine candidate against human cytomegalovirus, at~     three different dose levels.~   "
19751|NCT02798679|"~     The purpose of this study is to determine whether pre-existing cardiac fibrosis is a~     predictor of cancer treatment-related cardiotoxicity.~   "
19752|NCT02798666|"~     Background and aims: The purpose of this study was to evaluate the effect of high intensity~     interval training (HIIT) on body composition, physical fitness, metabolic fitness and muscle~     histology in men with overweight or obesity compared to continuous aerobic training (CAT).~      Material and methods: 16 male participants with overweight/obesity (age range: 42 - 57~     years, body mass index: 28 - 36 kg/m²) were randomized to HITT (n=8) or CAT (n=8). HIIT was~     composed of two sprint blocks of 10 minutes at ventilatory threshold (VT), within between a~     continuous block of 10 minutes, twice a week for 15 weeks. CAT was composed of three blocks~     of 10 minutes continuous endurance training at VT. After 5 weeks, intensity was increased to~     110% of VT. Changes in body composition, physical fitness (peakVO2 and anaerobic threshold~     (AT)), basal respiratory exchange ratio (bRER) and insulin sensitivity by oral glucose~     tolerance test were evaluated. Mitochondrial content was evaluated by transmission electron~     microscopy (TEM) in muscle biopsies.~   "
19753|NCT02798653|"~     This study is a randomized clinical trial to investigate the efficacy of different luteal~     phase support methods in patients with poor ovarian response undergoing IVF and~     intracytoplasmic sperm injection (ICSI) cycles.~      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan~     institute. The study is conducted according to the Declaration of Helsinki for medical~     research. All participants provide informed consent after counseling for infertility~     treatments and routine IVF/ICSI programs.~   "
19754|NCT02798640|"~     The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred~     change in local cutaneous blood flow, in healthy subjects wearing a control and a 100%~     Celliant® fiber upper torso garment.~   "
19755|NCT02798627|"~     NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine,~     NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with~     nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated~     cocaine self-administration. In several phase II clinical trials for major depressive~     disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359~     exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine.~     In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg~     of cocaine, but it attenuated the both the rewarding and cardiovascular effects of~     intravenous cocaine. On the basis of these promising studies, investigators propose a Phase~     II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will~     involve 100 CA subjects participating in an eight week trial, including a 1-week baseline~     and 8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication~     phase, there will be one follow-up visit. Subjects will be randomly assigned to treatment~     with placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse~     events. This dose range is selected on the basis of phase I and II evidence of tolerability~     and NS2359 plasma levels which were associated with blockade of cocaine reward. This project~     has the potential to identify the first effective pharmacotherapy for CA.~   "
19756|NCT02798614|"~     The purpose of this study is to compare the radiographic and clinical outcomes after short~     versus conventional plaster cast fixation time in reduced distal radius fractures.~   "
19759|NCT02798575|"~     Detecting exacerbations to prevent a severe and / or to early treat an exacerbation is~     crucial in patients with COPD in order to prevent hospitalization. Patients with invasive~     mechanical ventilation outside the hospital have a high re-hospitalization rate which is~     associated with severe economic burden since those patients need to be treated mainly on an~     ICU or a respiratory ward being able to take care of invasive mechanical ventilation.~      Recently, it has been shown that daily variations of parameters recorded by non-invasive~     ventilation (NIV) software are predictors of exacerbations in a cohort of COPD patients~     being treated outside the hospital with NIV [1]. These parameters were respiratory rate and~     percentage of respiratory cycles triggered by the patient.~      The aim of the present study is to detect parameters recorded by the ventilator which are~     able to predict exacerbation and / or hospitalization in patients with COPD under invasive~     mechanical ventilation outside the hospital.~   "
19760|NCT02798562|"~     The aim of this study is the clinical establishment of a native and contrast-enhanced~     computer tomography of the breast. The early detection of breast cancer is still a great~     challenge. Even though the implementation of the digital mammography combined with the~     mandatory screening-programs lead to significant improvements, sensitivity and specificity~     of these examinations need to be clearly classified as improvable. Generally, it is stated~     that the necessary transit from 2-D projected images to 3-D tomography will be crucially~     advantageous as magnetic resonance imaging has already shown. Similar or even major~     advantages can be expected by new approaches regarding CT with very high local resolution,~     better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a~     screening. A device that meets these demands and is also applicable for dynamic scans after~     intravenous administration of a contrast agent, has been developed with the support by the~     European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and~     Research (BMBF). Publications on technical and experimental results are already available.~     An evaluation in the clinical use is missing yet. The primary aim of this study is to~     evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of~     the breast.~   "
19761|NCT02798549|"~     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough~     understanding of the biology of one of its major causative agents, the hepatitis B virus~     (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is~     mounting evidence on several viral species that virion-bound proteins are prone to be~     involved either at the replication, budding/egress or entry/release steps of the viral~     cycle.~      Identifying such targets may yield ideal candidates for gaining insight on the dependence of~     HBV upon a restricted subset of host proteins, therefore providing refined sets of~     genetically stable targets for therapy. This project's goals are to set up adequate~     conditions for robust and reproducible purification of HBV virions in clinical samples,~     followed by the identification of their HBV-bound host proteins and the characterization of~     their functions. Proteomics profiling of HBV particles purified from clinical samples will~     be overlaid with proteins identified and characterized in cell culture grown HBV particles,~     using clinical biomarker discovery grade criteria. Targets identified in both samples sets~     will be subjected to in vitro investigations using HBV-replicating cells. Conventional~     biochemical and imaging methods will be used in order to: (i) ascertain their physical~     association with HBV virions; (ii) define the modalities of their interaction with HBV~     proteins; (iii) decipher the topology and subcellular localization of their association with~     HBV proteins and virions; (iv) quantitatively assess their functional involvement in~     particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory~     results in these experiments will be disclosed and further investigated at the level of~     structural biology, in collaborative research programs.~   "
19762|NCT02798536|"~     Background:~      LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in~     many tumors, including mesothelioma. But it is found in only a very small number of normal~     tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells.~     Researchers want to test LMB-100 in people with advanced mesothelioma.~      Objective:~      To find a safe dose and anti-tumor activity of LMB-100 for people with advanced~     mesothelioma.~      Eligibility:~      Adults ages 18 and older with:~      Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based~      therapy~      Adequate organ function~      Design:~      Participants will be screened with:~      Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure.~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Chest x-rays~      CT or MRI scans~      FDG-PET scans~      Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given~     through an IV catheter, a tube inserted in an arm vein. They will get standard medicines~     before each infusion to help prevent side effects. Each infusion lasts about 30 minutes.~     They will be monitored for up to 2 hours after.~      During each cycle, participants will repeat the screening tests.~      Participants will get the study drug for up to 4 cycles or until their disease worsens or~     they have intolerable side effects.~      About 4 6 weeks after their last infusion, participants will have a follow-up visit. They~     will repeat the study tests.~      Participants will have follow-up scans every 6 weeks until their disease gets worse.~      Participants will be called about once a year to see how they are doing.~   "
19781|NCT02798289|"~     The primary objective of this study is to evaluate acute tear production as measured by tear~     meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the~     Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.~   "
19782|NCT02798276|"~     The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft~     transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac~     function in patients with a chronic myocardial infarction. Preclinical studies in the~     porcine model of myocardial infarction have shown that the AGTP reduces infarct area and~     improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP~     is safe in patients.~   "
19796|NCT02798094|"~     The goal of this project is to learn more about the different ways in which people process~     information that is stressful and rewarding, and how abnormalities in these two processes~     are related to depression.~   "
20046|NCT02794792|"~     The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin~     of ipragliflozin in combination with metformin compared with metformin plus placebo in~     subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin.~   "
19763|NCT02798523|"~     Background:~      The immune system defends the body against bacteria and other harmful invaders. But it can~     overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs)~     can calm down an overactive immune system. But they often cause negative side effects.~     Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the~     body. They tell our cells how to function. Researchers hope the results of this study will~     show them how to develop better drugs that will have the benefits of GCs without the side~     effects.~      Objectives:~      To study how human genes respond to glucocorticoid drugs.~      Eligibility:~      Healthy adult volunteers ages 18 64.~      Design:~      Participants will be screened with a medical history and physical exam. They will have a~     heart test and blood tests.~      The study visit will last about 6 hours.~      Participants will have medical history, physical exam, and 3 blood draws.~      Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a~     tool will remove a piece of skin about as big as a pencil eraser.~      A GC cream will be applied to the other arm.~      Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip~     through a needle placed in an arm vein.~      Participants will have a skin biopsy of the arm that had the cream applied.~      Participants will have follow-up calls 1 and 4 days later. They will be asked about~     reactions or other health problems.~   "
19764|NCT02798510|"~     The present study is designed to determine whether adjuvant concurrent chemoradiotherapy~     improves overall survivals.~   "
19765|NCT02798497|"~     Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine~     leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and~     soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet,~     2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like~     symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute~     respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet,~     2002;359:753-9). Ten year after the first description of this disease and a number of~     controversies in the scientific literature, the question arise as to whether PVL remains an~     independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain~     unanswered yet; these are:~        -  (i) which factors, including treatment regimen, are associated with favourable~          outcome?,~        -  (ii) what is the susceptibility toward antibiotics of strains associated with this~          disease ?~        -  (iii) is there any genetic susceptibility of the host to explain both the rarity, and~          the explosive presentation of the disease ? To address the above questions a~          prospective observational study at the nationwide level will be set up. All French~          hospitals will be invited to describe the clinical features of all new cases of S.~          aureus community-acquired pneumonia with severity criteria, regardless PVL production.~          The study will include an investigation of a possible innate immune dysfunction in~          collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses,~          Faculté Necker, Paris). Hence, in addition to collecting clinical and biological data~          from all pneumonia cases as well as all strains of S. aureus isolated, the patients~          with PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome~          sequencing and functional studied)~   "
19766|NCT02798484|"~     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the~     loco-regional staging and direct the treatment.~      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement~     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care~     consists of realizing a MRI before the start of the NAC and another one after it's ended,~     six months later.~      There is currently no consensus on the realization of an interval MRI for early assessment~     of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic~     regimen in the event of a non response. Similarly, there is no consensus on when this~     interval MRI should be performed.~      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is~     interesting for the evaluation of the early response. However, these are preliminary studies~     with quantitative measures realized by the region of interest (ROI) method. A response to~     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients~     (ADC).~      The investigator's goal for this study is to evaluate the reliability of diffusion as tumor~     biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted~     magnetic resonance sequences in the pre-therapeutic assessment and the early and late~     follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...)~     within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI~     results obtained at the end of the treatment and with the histology of the initial biopsy~     and the surgical specimen.~      The expected benefits are:~        -  to establish correlations between apparent diffusion coefficients (ADC) values and~          histology~        -  to observe changes in the ADC according to the type of response: ADC increase in the~          event of partial response, ADC stability in the event of non response, ADC decrease in~          the event of a progression, absence of restriction in the event of a complete response.~        -  to confirm that diffusion weighted MRI within a short interval (after one cure, at one~          month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.~   "
19767|NCT02798471|"~     This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint~     evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is~     designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to~     compare the efficacy and safety of edoxaban against standard of care in pediatric subjects~     with confirmed VTE.~   "
19768|NCT02798458|"~     Patients will undergo a SmartPill test to gain additional understanding of Fabry disease~     manifestation via motility abnormalities in order to improve symptom targeted therapy. An~     additional Endoscopic mucosal resection may be performed on further qualifying patients.~     Tissue analysis from this biopsy will include evaluation of abnormalities of cellular~     structure and morphology with correlation with gastrointestinal complaints for each patient~     and comparison against age matched non-Fabry patient tissue. The hypothesis is that patients~     with fabry disease will have abnormal motility which will correlate with the patients~     symptoms and quality of life as noted on the questionnaires.~   "
19769|NCT02798445|"~     The aim of this study is to determine the percentage of healing of active venous ulcers~     following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and~     adjustable compression system versus a control group using the traditional multilayer~     bandages.~   "
19783|NCT02798263|"~     The pain is very common complaint, and the neck is one of the most affected spots, mainly~     due to muscle contracture of the cervical and scapular region, triggered by emotional stress~     associated with muscle retraction involved resulting from postoperative scarring or~     post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual~     impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to~     the appearance of pain.~      Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional~     disorders of women undergoing surgery for breast cancer.~        1. Presence of pain by Visual Analog Scale of Pain (VAS).~        2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension,~          adduction, abduction, internal rotation and external rotation~        3. lymphedema presence through top member perimetry.~        4. upper limb function through the DASH questionnaire.~        5. Depressive symptoms through BECK questionnaire.~        6. Quality of life through the EORTC questionnaire.~        7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and~          shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette~          Instrument Company.~      Patients will be divided into three randomized groups with 30 patients per group, who will~     receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic~     exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises~     for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical~     acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture~     points of the group II, but using the Stiper® in place of the needles. If the patients in~     groups II and III still of pain at the end of 10 sessions will be treated complementarily~     with kinesiotherapy.~   "
20085|NCT02794285|"~     The purpose of this study is to characterise long-term safety and tolerability of~     intravenous anifrolumab.~   "
19770|NCT02798432|"~     Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene~     cemented tibial component1. Based on finite-element analysis studies reporting superior~     force distribution compared with conventional all-polyethylene components, metal-backed~     tibial baseplates have dominated the TKA implant market since the middle of the 1980's2.~     These modular implants provided excellent long-term implant survivorship3.~      As TKA became increasingly successful, younger patients increasingly became eligible.~     Increasing life expectancy has raised the concern that cemented TKAs may not withstand~     prolonged use, particularly in younger patients4. Patients younger than 65 years are~     projected to account for more than 50% of patients undergoing TKA by 2016 and to more than~     50% of patients undergoing revision surgery by 2011. The number of total knee revisions in~     the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.~      Many authors have reported excellent and equivalent results of cemented and cementless~     TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been~     the tibial component, and, therefore, the preference for many surgeons still remains to~     cement the tibial component9,10. The femoral component may be the most suitable for~     cementless fixation11-13. However, the best femoral method of fixation is still being~     discussed. Currently, the decision to cement or not to cement the femoral component is based~     on the surgeon's preference14.~      The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and~     the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen~     LPS leads to equally successful results as the cemented TKA gold standard~   "
19771|NCT02798419|"~     DFD05 vs. Active01 in the treatment of common warts~   "
19772|NCT02798406|"~     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of~     malignant brain tumor in adults and can be resistant to conventional therapies. The purpose~     of this Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor~     responds to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when~     delivered directly into the tumor followed by the administration of intravenous~     pembrolizumab (an immune checkpoint inhibitor) given every 3 weeks for up to 2 years or~     until disease progression.~      Funding Source-FDA OOPD~   "
19773|NCT02798393|"~     This is a double blind, randomized, placebo-controlled study in which a total of 120~     patients will be selected from a broad spectrum group of typical Americans (all demographics~     including various races and both genders as well as ages from 25-90) who have confirmed Type~     2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy.~     All patients will meet inclusion and/or exclusion criteria.~   "
19774|NCT02798380|"~     The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519~     Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.~   "
19775|NCT02798367|"~     National clinical trials, phase III/II, combined in two stages, randomized, double-blind,~     controlled, parallel, study of superiority, in which two hundred fifty-six (256)~     participants of both sexes, aged equal or more than 55 years will be randomly allocated to~     one of three treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus~     CBT-I, the group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus~     placebo.~      Based on the results of an interim analysis will be making a decision on whether to proceed~     with the study and, if so, on which the doses will be selected for the second stage of the~     study, to be better studied. The final analysis of the treatments, melatonin in the selected~     dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.~   "
19776|NCT02798354|"~     The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors~     each representing a unique dimension of diagnostic assessment: evaluation of symptoms,~     evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms)~     affects nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes~     significant morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87%~     of patients, often due to inaccurate application of blood pressure parameters that change~     based on age, gender and height. Actionable pediatric laboratory values (diagnostic tests)~     are potentially delayed up to 26% of the time in preliminary investigations and 7-65% in~     adults, leading to harm and malpractice claims.~      The investigators propose to conduct a multisite, prospective, stepped wedge cluster~     randomized trial testing a quality improvement collaborative (QIC) intervention within the~     American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce~     the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of~     over 300 primary care practices, ranging from tertiary care academic medical centers to~     single practitioner private practices, interested in and experienced with QICs. Because many~     processes are likely to be common across diagnostic errors in outpatient settings, a~     multifaceted intervention, such as a QIC, has a high likelihood of success and broad~     applicability across populations. Preparatory inquiries to QuIIN primary care providers~     suggest high interest in reducing these 3 diagnostic errors and provider agreement with~     randomization to evaluate diagnostic error interventions. Practices will be randomized to~     one of three groups, with each group collecting retrospective baseline data on one error~     above, and then intervening to reduce that error during the first eight months. Each group~     will concurrently collect control data on an error they are not intervening on during those~     eight months. Following those eight months, the groups will continue intervening on their~     first error, begin intervening on the error they were a control site for, and begin~     collecting data on the third error for which they will be a control site for. Finally, in~     the final eight months, all groups will intervene on all three errors. A second wave of~     practices will be recruited to join the groups after eight months and will only intervene on~     two of the three errors.~   "
19777|NCT02798341|"~     TRACR will provide a data/biospecimen repository for translational research to better~     diagnose, prognose, treat and cure breast cancer (and related diseases/treatment~     conditions). Patients at the Rowan Breast Center will be consented for donation of blood and~     if available tumor/healthy/archived tissue. Patients will be consented to give permission to~     use said specimens for future research and to be contacted in the future about other~     research participation and additional information.~   "
19778|NCT02798328|"~     Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and~     classify the presence of DOAC drugs in a subject.~   "
19779|NCT02798315|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
19780|NCT02798302|"~     Healthy volunteers will participate in a crossover trial comparing preoxygenation with a~     non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the~     flush rate of oxygen (fully opening standard oxygen flowmeter).~   "
19794|NCT02798120|"~     This is a multi-center, open label long-term safety (LTS) study to be conducted in~     approximately 600 subjects with acne vulgaris.~   "
19784|NCT02798250|"~     In previous studies, investigators have studied if a pre-meal insulin bolus based on~     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without~     a significant degradation in postprandial glucose control. With this strategy, the patient~     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,~     large or very large). It is however important to establish the safety of this simplified~     meal bolus approach. The safety of overestimating a meal insulin bolus in the context of~     closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone~     closed-loop will be tested.~      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus~     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an~     adequately estimated meal size bolus.~   "
19785|NCT02798237|"~     Physical activity level is an important determinant of quality of life in persons~     post-stroke. There is a lack of knowledge regarding the effects of overground walking~     aerobic training on physical activity level and cardiorespiratory fitness in post-stroke~     subjects. Therefore, the aim of this study is to compare the effects of aerobic overground~     training, aerobic treadmill training and overground training to improve physical activity~     level, cardiorespiratory fitness, endurance, mobility, quality of life and participation in~     participants post-stroke. A randomized controlled trial with blinded assessment will assign~     eligible participants to either: 1) aerobic overground training, 2) aerobic treadmill~     training, or 3) control group (overground walking). Participants will receive three 40~     minutes sessions per week on 60-80% of heart rate reserve (groups-1 and 2), and below 40%~     (group-3) over 12-weeks. At baseline, post-intervention, and at 4-week follow-up researchers~     blinded to group allocations will collect the following outcome measures: physical activity~     level, cardiorespiratory fitness, endurance, mobility, quality of life and participation. We~     hypothesize that the two aerobic training groups (overground and treadmill), would have an~     increase on physical activity level and on cardiorespiratory fitness (peak VO2), as well as~     endurance, mobility, quality of life and participation. In addition, the control group would~     not improve in any of these outcome measures.~   "
19786|NCT02798224|"~     To compare patient perceptions, intent to screen and screening use among those using a~     patient portal with and without a colorectal cancer (CRC) screening decision support tool,~     e-Assist.~      To evaluate whether the effectiveness of e-Assist in moderated by multi-level factors~     including patient health literacy, decision-making preference and CRC screening decision~     stage.~      To assess program impact and create an implementation guide for e-Assist by combining~     results from Aims 1 & 2, a program implementation analysis/process evaluation and the~     perspectives of staff from future diverse implementation sites including small primary care~     practices, University-based primary practices and federally qualified health centers.~   "
19787|NCT02798211|"~     To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in~     adult patients with active PsA based on the proportion of patients achieving an American~     College of Rheumatology 20 (ACR20) response.~   "
19788|NCT02798198|"~     Objective: The main target of this study was to research the early changes in pulmonary~     function and intrarenal hemodynamics, then research the correlation between the pulmonary~     function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic~     kidney disease (DKD).~      Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group)~     were choosed to research early changes in pulmonary function and intrarenal hemodynamics,~     then research the correlation between the pulmonary function and the renal blood flow in~     T2DM patients, all having normal renal function. The primary endpoints were the pulmonary~     function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%);~     the secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral~     interlobular renal arteries were evaluated using; the tertiary endpoints were the~     biochemical variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN,~     Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio~     (UACR) were measured.~   "
19789|NCT02798185|"~     This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE)~     during life, as well as to examine possible risk factors for this neurodegenerative disease.~     Once component of this study is the use of an investigational PET scan radio tracer to~     detect abnormal tau protein in the brain.~   "
19790|NCT02798172|"~     Objective: To observe the effect of alogliptin combined with metformin on pulmonary function~     in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy (500~     mg, bid po, for at least 3 months), and evaluate its efficacy and safety.~      Method: After a 2-week screening period, adult patients (aged 36-72 years) entered a 4-week~     run-in/stabilization period. Then, patients were randomly assigned to either the~     intervention group (n=55) or control group (n=50) for 26 weeks. The patients in the control~     group were given metformin (1,000 mg, bid po) and the patients in the intervention group~     were given metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po). All the~     patients received counseling about diet and exercise from a nutritionist during run-in and~     treatment periods.~      The primary endpoints were the between-group differences in the changes pulmonary function~     parameters [VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%] between~     pretherapy and posttreatment. The secondary endpoints were changes from baseline to week 26~     in HbA1c, FPG, 2hPG, HOMA-IR, WC, and BMI. The tertiary endpoints were the changes from~     baseline to week 26 in blood-fat (TC, HDL-C, LDL-C, and TG). The quartus endpoints were the~     changes from baseline to week 26 in SBP and DBP. The fifth endpoints were the changes from~     baseline to week 26 in oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX). In~     addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and~     electrocardiographic readings).~   "
19791|NCT02798159|"~     The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of~     erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with~     the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil~     Citrate taken as needed over one month (phase III)~   "
19792|NCT02798146|"~     This pilot-study will help characterize the serum progesterone profiles in IVF patients and~     correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous~     gonadotropins.~   "
19793|NCT02798133|"~     The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to~     low tidal volume (VT) ventilation, with or without an individualized post-RM positive~     end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.~   "
19797|NCT02798081|"~     A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course~     for beginners will participate in the study. The evaluation will consist mainly in answering~     two validated questionnaires on socialization, the short Social and Emotional Loneliness~     Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and~     performance will also be measured by three virtual reality games, namely Reaction Time,~     Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at~     baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics~     classes which includes 15 minutes for practicing virtual reality games.~   "
19798|NCT02798068|"~     Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal~     insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an~     intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation~     alterations, specially in endothelial cell and its protective layer - glycocalyx.~     Endothelial dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is~     associated with bad prognosis.~      High - dose corticoids administration at anesthesia induction in cardiac surgery could~     attenuate the intensity of this inflammatory reaction, and represents the current practice~     in our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery~     centres.~   "
19799|NCT02798055|"~     GRegistry is a significant collection of data and information on the clinical practice of~     systemic scleroderma finger ulcers.~      The GRegistry study is a nationwide (Greece) prospective study recording, which includes~     consecutive patients with SC-DU diagnosis in clinical management departments of different~     hospitals, selected in such a way as to reflect a representation of the country.~      The use of Bosentan in the treatment of patients suffering from systemic sclerosis with~     digital ulcer disease is supported by data from large, placebo-controlled, randomized~     studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic~     sclerosis consistent with its beneficial effect on pulmonary arterial hypertension~     associated with connective tissue disease and its beneficial effect on vascular remodeling.~   "
19800|NCT02798042|"~     Acute kidney injury (AKI) is a common, but significant complication after elective surgery~     which is associated with an increased risk of mortality, major adverse cardiac events,~     prolonged length of hospital stay, and increased cost per episode of care.~   "
19801|NCT02798029|"~     The goal of this clinical research study is to learn if a type of radiation therapy called~     frameless fractionated stereotactic radiation therapy (FFSRT) is effective for treating~     participants with brain metastases. The safety of this therapy will also be studied.~   "
19802|NCT02798016|"~     Investigators will collect blood specimens from the participating patients and then blood~     samples will be centrifuged in order to collect platelet-rich plasma which is going to be~     injected in the atrophic acne scars. A split-face design is going to used in this randomized~     controlled trial. In the control side of the face, micro-needling to the skin will occur~     using a specific tool (Dermapen).~   "
19803|NCT02798003|"~     To study activity in the reward-circuitry of the brain in patients suffering from cachexia~     induced by cancer or chronic disease.~   "
19804|NCT02797990|"~     Qualitative project, comprising open-ended semi-structured interviews with healthcare~     workers, who provide antenatal care to substance-using women.~   "
19805|NCT02797977|"~     CCT245737 is a type of drug called a kinase inhibitor. It blocks a chemical messenger~     (enzyme) called checkpoint kinase 1 (CHK-1) which is part of the signaling process within~     cells which can make cells produce chemicals that trigger and control cell growth and cell~     death. Chemotherapy agents are used to try to kill cancer cells however sometimes cancer~     cells can repair themselves using these signaling processes and continue to grow. It is~     thought that CCT245737 may help chemotherapy to work better by preventing cancer cells from~     repairing themselves, when they have been damaged by the chemotherapy, so that more cancer~     cells will be killed.~      There are 2 stages to this study:~        1. Patients in Stage 1 will be given CCT245737 to take in addition to receiving treatment~          with gemcitabine and cisplatin.~        2. Patients in Stage 2 will be given CCT245737 to take in addition to receiving treatment~          with gemcitabine only.~      The main aims of the study are to find the maximum dose of CCT245737 that can be given~     safely to patients with gemcitabine and cisplatin or gemcitabine alone, more about the~     potential side effects of the drugs and how they can be managed and what happens to the~     combination of drugs inside the body.~   "
19806|NCT02797964|"~     The main aims of this clinical study are to find out the maximum dose of CCT245737 that can~     be given safely to patients, more about the potential side effects of the drug and how they~     can be managed and what happens to CCT245737 inside the body.~      CCT245737 is a type of drug called a kinase inhibitor. It blocks a chemical messenger~     (enzyme) called checkpoint kinase 1 (CHK-1) which is part of the signaling process within~     cells. This can make cells produce chemicals that trigger and control cell growth and cell~     death. In some types of cancer these chemical messengers are 'switched on' or 'switched off'~     allowing the cancer cells to keep growing and to grow more quickly than normal cells. Kinase~     inhibitors are a new type of drug being used to try to stop the growth of cancers and to~     kill cancer cells~   "
19807|NCT02797951|"~     The main purpose of this study is to assess the long-term safety and tolerability of~     galcanezumab administered up to once monthly in participants with episodic or chronic~     cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM~     (NCT02438826).~   "
19808|NCT02797938|"~     Endotracheal pressure with different cuff shapes can result in different cuff pressure~     change after head positional change. In this study, 52 patients underwent middle ear surgery~     with general anesthesia were randomly allocated to two group; patients were intubated with~     taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with~     sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22~     centimeters of water in the neural head position and was measured after the change to the 45~     degree head rotation. The change of cuff pressure was compared between two groups~   "
19845|NCT02797652|"~     Our study aims to evaluate the possibility of clinical application of CTDNA detection in~     samples or peripheral blood of breast cancer patients, so as to act as the new techniques or~     indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast~     cancer.~   "
19809|NCT02797925|"~     There has been an increasing amount of musculoskeletal injuries the past decades and~     overused tendons represents a major problem both for leisure and occupational activities. A~     full understanding of the pathophysiology of tendinopathy is very sparse and especially the~     early events in tendinopathy remains unexplained. In this phd study the investigators will~     investigate early changes in tendon tissue overloading and development of tendinopathy. The~     investigators will investigate sports-active individuals with recently developed~     tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography,~     MRI and electron microscopy), tendon mechanical properties (ultrasonography strain), tissue~     molecular biology (expression and content of matrix proteins), inflammation (activity of~     inflammatory pathways) and vascularization (Doppler and contrast enhancement US). The~     investigators hypothesize a coupling between early symptoms and inflammatory activity,~     followed by structural changes and altered mechanical properties. The investigation will~     indicate what symptoms and what tendon related determined measurements are primary for~     disease development (tendinopathy blue prints) and should be regarding vital in prevention~     of tendinopathy.~   "
19810|NCT02797912|"~     In patients with cystic fibrosis (CF) the commonest cause of death is respiratory failure.~     Respiratory failure can have many causes. However, in patients with CF a major contributor~     is the impairment of the muscles required for breathing (respiratory muscles). Respiratory~     muscle impairment can result from poor nutrition. Lung function declines particularly during~     adolescence whilst body composition also changes at the same time. Thus, the investigators~     plan to study the relationship of nutrition and body composition to respiratory muscle~     strength and lung function in children and young people with CF aged between 12-18 years.~     The body mass index (BMI) is currently used in the clinical setting to measure nutritional~     status in CF. At King's College Hospital (KCH) there are portable devices to assess both~     respiratory muscle function and lung function. The research team will use a Bioelectrical~     Impedance Analysis (BIA) device to assess body composition, including BMI and lean body mass~     (LBM). The aim of the study is primarily to assess whether measurements of LBM impairment~     may better relate to poor lung function compared to BMI and secondly to examine whether lung~     and respiratory muscle function correlates with exercise tolerance.~   "
19811|NCT02797899|"~     Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions.~     This prospective clinical trial was conducted aiming to determine whether the addition of an~     autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and~     decrease pain scores.~      Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue~     dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive~     PRF or not by a flip of a coin during the screening visit. Patients were instructed to~     complete a pain study form. The palatal donor area were evaluated for complete wound healing~     records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks~     postoperatively.~   "
19812|NCT02797886|"~     The goal of the study is to explore the effect of combined training involving functional~     electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort~     voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke~     patients. Participants will be assessed for functional motor ability and neurological~     function during their first visit and then again after five and then ten weeks of training.~     Functional motor ability is broken down into dorsiflexion strength and general gait~     analysis. Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via~     recordings of electromyography, pedobarography, kinematic, and various functional variables~     during 10 walking trials. The neurological assessment will include electroencephalographic~     (EEG) analysis of movement-related cortical potentials (MRCP), somatosensory evoked~     potentials (SSEP), and M-wave response to stimulation. Participants will be randomly~     assigned to one of three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3)~     VOL alone, which will determine their training regimen. The training sessions involve~     roughly 20 minutes of repeated muscle contractions (with appropriate breaks to avoid~     fatigue). The participants assigned to the FES+VOL group will receive electrical stimulation~     to the peroneal nerve in concert with volitional dorsiflexion, whereas the other groups will~     either dorsiflex voluntarily with no stimulation or receive stimulation while being asked to~     do nothing.~   "
19813|NCT02797873|"~     The purpose of this study is to investigate how emotional and non-emotional regulation~     processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity)~     compared to controls. The investigators will test these participants' abilities to regulate~     emotional and non-emotional processes, reward anticipation and reward receipt while they~     undergo functional magnetic resonance imaging (fMRI). The participants' motor inhibition~     capacity on a behavioral level will also be investigated.~      The hypothesis is that EIP patients will present with more deficits in emotion regulation~     processes compared to controls, even when controlling for ADHD symptoms. It is also~     hypothesized that higher levels of ADHD symptoms will correlate with dysfunctional~     non-emotional regulation processes, on a behavioral as well as brain mechanistic level.~   "
19814|NCT02797860|"~     Pregnancy is associated with major changes of the body's physiological status and~     composition.~      These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs.~     Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are~     attributed to the following factors; Increase in plasma volume, heart rate and cardiac~     output; decrease in blood pressure due to decrease of systemic resistance and relative~     decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes~     intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset~     time and duration of muscle relaxants.~      Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly~     excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and~     is widely used in general anesthesia of pregnant women. Previous studies reported onset time~     of rocuronium is affected by cardiac output, blood circulation time of the whole body, and~     muscle perfusion. Accordingly, many researches were conducted under the assumption of onset~     time and duration being affected by physiologic changes during pregnancy. For example, in~     the research where vecuronium was used as muscle relaxant for pregnant woman undergoing~     C-sec, onset of vecuronium was significantly shorter than that of the control group and~     duration was longer. In a study investigating rocuronium used for patients right after~     delivery, onset time was shorter and duration was longer than that of the control group.~      However, previous research mostly focused on the 3rd trimester, while there have been only a~     few studies of onset time and duration of rocuronium in non-obstetric surgery such as the~     transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under~     general anesthesia during 2nd trimester. In this research, onset time and duration of~     rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females,~     will be compared with those of patients in the control group.~   "
19815|NCT02797847|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-TTRSC02 in healthy subjects.~   "
19816|NCT02797834|"~     The main aim of this study is to describe the morphology, size distributions and specific~     markers of the different vesicles populations present in the human endometrial fluid. To~     further characterize the vesicles populations, contents of these membrane compartments~     (i.e.: DNA, RNA, proteins, lipids and other small metabolites) will be assessed by using~     mass spectrometry and next generation sequencing techniques. The objective here is to relate~     a specific vesicles composition to the moment of the cycle, to a normal physiological~     endometrial function and to the transmission of functionalities from the mother to the~     embryo.~   "
19817|NCT02797821|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD)~     of asfotase alfa in adult patients with pediatric-onset HPP.~   "
19818|NCT02797808|"~     The investigators will examine how treatment with sertraline for 12 weeks impacts~     frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.~   "
19819|NCT02797795|"~     This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation~     trial to be conducted in 2 sequential parts:~        -  Part A (Dose Escalation) in subjects with advanced malignancies~        -  Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results~          of Part A~   "
19820|NCT02797782|"~     More than two billion individuals have serological evidence of hepatitis B virus (HBV)~     infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000~     hepatitis B related deaths occur annually.~      Currently available hepatitis B vaccines are extremely safe and have an efficacy of >90~     percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be~     eradicated through global vaccination. A positive immune response to the vaccine is defined~     as the development of hepatitis B surface antibody (anti-HBs) at a titer of >10 mIU/mL.~      Although anti-HBs titers decrease with time, the duration of protection is long. Protection~     has been estimated to persist for up to 22 years after the primary vaccination schedule.~     Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is~     probably due to the priming of memory cells, which are capable of eliciting an anamnestic~     response when challenged. This is supported by the rapid increases in anti-HBs titers in~     previously vaccinated individuals who administered booster injections.~   "
19821|NCT02797769|"~     This retrospective cohort study will analyze data from multiple large U.S. health insurance~     claims databases to compare use of tocilizumab to other biologic disease-modifying~     anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing~     as the index date, the analysis will compute the time to first event for several~     cardiovascular outcomes.~   "
19822|NCT02797756|"~     Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be~     performed, investigators will conduct a chart review to obtain relevant clinical data and~     the investigators will use an aliquot of airway sample obtained during the clinically~     indicated bronchoscopy for microbiome analysis. A case-control study design will be used to~     study whether subjects with CC with GER have a distinct lung microbiome and increased~     inflammation as compared with subjects with CC without GER and to determine whether the~     microbiome and degree of inflammation is related to the type of GER (acidic versus~     nonacidic).~   "
19823|NCT02797743|"~     This study will obtain whole blood specimens from healthy subjects to be used for research~     and development and clinical validation of genetic assays.~   "
19824|NCT02797730|"~     Diagnostic of diabetes in childhood brought modification of family way of life, particularly~     in child and caregivers lifes.~      The education patient programs are in France centered on curative competencies of care.~      It is possible that art-therapy improve psycho-social competencies The aim of the study is~     to evaluate art-therapy sessions on quality of life of caregivers~   "
19825|NCT02797717|"~     Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical~     Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy~     intensification randomisation in intermediate and advanced classical Hodgkins lymphoma~     patients to compensate for reduction in RT.~   "
19826|NCT02797704|"~     The goal of this current study is to prospectively evaluate the influence of a single~     subconjunctival aflibercept injection on the regression of corneal neovascularization.~     Twenty patients with corneal neovascularization who are candidates for anti VEGF treatment~     (by the discretion of a corneal specialist) will be included in this study. The patients~     will be treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in~     a single quarter of the conjunctiva, near the limbus in a proximity to the area of~     pathological neovascularization. Regression of neovascularization will be documented.~   "
19827|NCT02797691|"~     CBT for common mental disorders has a strong evidence base in both the USA and the UK. There~     are wider cultural and linguistic differences between Non Pashtun and Pashtun population of~     Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need~     some adaptations when working with clients from non-western background. This study, thus,~     aims to culturally adapt CBT for common mental disorders for Pashto speaking population in~     Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small~     scale pilot study.~      The study will be carried out using mixed methods; quantitative and qualitative. Qualitative~     part will consist of structured interview with a minimum of 10-15 patients; carers; and~     mental health professionals, respectively, using the interview questionnaires. The data will~     be analysed by systematic content and question analysis which will identify the emerging~     themes and categories. The data will then be reorganized into wider themes and categories~     and written for guidelines to culturally adapt therapy manual for common mental disorders.~      Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the~     effectiveness of a CaCBT intervention for Pashto speaking patients. All those who fulfill~     the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10~     RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be~     included in the study.~      The intervention group of the RCT will receive CaCBT intervention in addition to the~     treatment as usual (TAU) while the control group receives TAU. The assessment will be~     carried out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory~     (BSI), Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire~     (BDQ)/ WHO DAS will be used to measure somatic symptoms, anxiety, depression and disability~     due to physical and psychological problems, respectively. Schwartz Outcome Scale will be~     used at follow up to measure the outcome.~   "
19846|NCT02797639|"~     Objective: Developing and corroborating the Collaborative Consultation for Participation of~     Students with Intellectual Disability (Co-PID) program, for enhancing classroom~     participation among students with moderate Intellectual and Developmental Disability (IDD).~      Method: study took place in two special education schools and included students with~     moderate IDD (n=60) and their teachers (n=11). The settings were randomly assigned to~     intervention or control group. In the intervention group, Co-PID program was employed; in~     the control group an In-Service (IS) was employed. Participation was evaluated at pre-test~     and post-test.~   "
19828|NCT02796638|"~     The primary hypothesis of this study is: the use of minute ventilation-adaptive~     servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal~     function and prevent kidney injury in patients admitted with acute heart failure (AHF)~     compared to those receiving usual care. We will validate and extend our pilot study by~     taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and~     exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct,~     it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm~     for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom~     chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the~     Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for~     continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases~     in effective glomerular filtration. Since kidney injury is a major factor in those patients~     with early 30-day readmission following discharge, this therapy could become quite popular.~   "
19829|NCT02796625|"~     The investigators will use non-invasive recordings of brain activity to measure pain as a~     proxy to self-report. Participants will undergo testing for about 3 hours on two separate~     days. The testing will involve experiencing painful heat.~   "
19830|NCT02796612|"~     The project investigates prospectively whether anxiety in the context of breast biopsy can~     be reduced by the planed intervention (take-home brochure and structured and standardized~     information given by a psychologically trained physician who performs the biopsy).~   "
19831|NCT02796599|"~     The purpose of this study is to determine wether the interface (facial or nasal mask)~     influences performance in patients with chronic obstructive pulmonary disease exercising~     with non-invasive ventilation.~   "
19832|NCT02796586|"~     To evaluate the feasibility and effectiveness of group contraceptive counseling on family~     planning knowledge acquisition, service satisfaction, method uptake and continuation among a~     group of resettled African refugee women.~   "
19833|NCT02796573|"~     Depression is a prevalent and disabling disorder with great cost to the individual and the~     society. Lately, the use of internet interventions as guided self-help has demonstrated~     remarkable results. However, certain shortcomings such as lack of personal adaptation has~     been identified.~      The presents study aims to investigate the potential of blending Internet based~     interventions with face-to-face consultations using cognitive behavioural therapy (B-CBT).~     The main hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it~     will be acceptable to patients and clinicians.~      The study is designed as a two arm randomised non-inferiority trial comparing internet based~     B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.~   "
19834|NCT02796560|"~     The purpose of this study is to compare the efficacy and tolerance of generic travoprost~     with its brand name formulation. In this open label, randomized, crossover study, the~     primary outcome will be intraocular pressure and the secondary outcome will be tolerance to~     the drops, as measured by a subjective questionnaire. Patients will be randomized to receive~     either brand name or generic travoprost during the first visit. At the second visit 3 weeks~     later, their intraocular pressure will be measured and a questionnaire will be completed on~     the tolerance of the medication. Patients will then receive the other formulation of~     travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure~     will be measured and a questionnaire will be completed on the tolerance of the second~     medication.~   "
19835|NCT02796547|"~     An episiotomy is an incision of the perineum to facilitate childbirth by natural means.~     Perineal pain are more frequent and intense if the incision of the perineum is important. In~     particular, simple vaginal or perineal tears are less painful than episiotomies in the first~     seven days postpartum, whereas at six weeks postpartum, there is no significant difference~     anymore.The patients are the most symptomatic in the immediate postnatal period, but the~     pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often~     undervalued and may interfere with the mother-child bond in the absence of an effective~     treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal~     anti-inflammatory drugs given orally or rectally and paracetamol.~      The scar infiltration is one of the components of a multimodal postoperative analgesia~     strategy. It consists in the simultaneous use of several drugs or analgesic techniques,~     acting on different pain components in order to improve the overall efficiency.The most used~     local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine~     has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the~     injection point and a blood resorption that is more spread. The systemic toxicity threshold~     is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects,~     and an intermediate systemic toxicity threshold intermediate between bupivacaine and~     ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in~     complement infiltrations when a rapid onset of action is desired.~      So far, there is no data in the literature regarding the effect of levobupivacaine in~     episiotomies associated pain. The objective of this study is to evaluate the effect of local~     injections of levobupivacaine on episiotomies associated pain.~   "
19836|NCT02796534|"~     Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular~     or neuropathic complications; in addition to an optimal treatment, prevention of diabetes~     complications requires to control associated risk factors, such as hypertension or~     dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and~     marked morbidity and mortality, one increasingly interesting aspect is its relationship with~     metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be~     underestimated in this population. In this context, it appears to be important to estimate~     the prevalence of sleep respiratory diseases in patients with type 1 diabetes.~   "
19837|NCT02796521|"~     At hospital, short term actions are used (adaptation of meals, oral supplementation…) to~     fight malnutrition. Oral supplementation can have a positive impact on weight gain. But~     actions should continue at home, particularly to maintain autonomy for elderly. The~     hypothesis is that practical workshop about enrichment and interest of foods can help~     malnourished patients to change their eating habits. The main goal of this study is to~     evaluate the effects of this workshop on improving nutritional status, measured by Mini~     Nutritional Assessment~   "
19847|NCT02797626|"~     Primary objective:~      to evaluate progression-free survival in patients with clinical stage II A/B seminomatous~     germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without~     adjuvant treatment~      Secondary objectives:~        -  overall survival~        -  perioperative complications (Clavien-Dindo score)~        -  quality of life (EORTC QLQ C30, EORTC QLQ TC26)~        -  long term sequelae~        -  rate of retrograde ejaculation~   "
20086|NCT02794272|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in older~     people, compared to sham tDCS.~   "
19838|NCT02796508|"~     Neuroplasticity-based approaches seem very promising to maintain cognitive health in older~     adults and postpone the onset of cognitive-decline and dementia symptoms. The aims of this~     project are threefold:~        1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized~          computer-based intervention consisting in training with non-action video games on brain~          and cognitive functions that decline with ageing, including attention and spatial~          working memory (WM), in older adults using behavioral measures and electrophysiological~          recordings (event-related potentials -ERPs- and event-related spectral perturbations~          -ERSPs);~        2. the study of the effects of age and 3 months maintenance on the cognitive and neural~          signatures of transfer effects to attentional and spatial WM tasks; and~        3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in~          saliva from participants underlying cognitive training-induced effects.~      A better understanding of these mechanisms elucidates pathways that may be targeted in the~     future, either by behavioral or neuropsychological interventions. To achieve these aims, the~     investigators will recruit between 60-80 older adults volunteers to participate in the~     randomized, controlled, single-blind study. After screening, participants will be randomly~     distributed in one of these two groups: experimental and active control. Participants in the~     experimental group will receive 16 1 hour computerized training with non-action video games.~     The active control group will receive 16 1 hour training sessions with a social video game.~     The design is a mixed factorial design with type of intervention (experimental, active~     control) and assessment session (pre, post, maintenance). The results from the proposed~     research project will clarify the existence of transfer-of-benefit and neural mechanisms~     underlying cognitive improvement. The hypothesis is that mental stimulation through~     non-action video games will improve attention and memory, promoting brain and mental health,~     and extending independence among elderly people by avoiding the negative personal and~     economic consequences of long-term care.~   "
19839|NCT02796495|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might~     be elicited or worsened by a range of physical factors (e.g. changes in the weather or~     pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well~     known that most treatments available for PLP today, such as pharmacological, surgical,~     anaesthetic, psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical~     reorganization and alleviation of phantom limb pain has been observed in amputees following~     intense use of a hand prosthesis. However, there is no consistent knowledge on which type of~     peripheral sensory feedback may be effective in affecting the cortical plasticity or on how~     to best apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing invasive sensory feedback (i.e. electrical stimulation through intraneural~     implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore~     the cortical neuroplastic changes.~   "
19840|NCT02796482|"~     This open-label, prospective, controlled intervention study involves evaluating tolerance~     and acceptability of an Oral Nutrition Supplement (ONS; EnergieShake® 1.5 kcal Complete~     drink) in 18 adult patients who are already taking an ONS. Following a 2-day baseline data~     collection on their current ONS, patients switch to the test ONS, which is taken for a~     further 8 consecutive days. Patients revert to their current ONS at the end of the study.~     Patients act as their own controls and thus all patients are allocated the same~     intervention.~      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept~     for participants throughout the study period. Participants' height and weight will be~     collected at baseline (weight at end will also be collected), all medications will be~     documented, and relevant medical and dietary histories will be recorded. A questionnaire at~     the end of the intervention period will be administered collecting participants' views on~     the acceptability (taste and palatability) of the test ONS. Taste and palatability will be~     assessed via a questionnaire that uses a Hedonic scale to quantify preference.~   "
19841|NCT02796469|"~     In the specific setting of the evaluation of corticosteroids, pentoxifylline of their~     combination in severe alcoholic hepatitis, only meta-analysis combining individual data is~     able to provide detailed information from each individual with severe alcoholic hepatitis~     assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both~     univariate and multivariate analyses, truth survival is lower for conclusions from~     meta-analysis of the literature than for conclusions derived from non-meta-analyses.~      The present study is a meta-analysis of individual data from RCTs restricted to patients~     with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients~     receiving either corticosteroids, or pentoxifylline or their combination to those of~     patients not receiving them adjusted on the independent prognostic factors at baseline.~      The secondary endpoints will be: a) assessment of response to the assigned treatment using~     the Lille model; b) analysis of 6-month survival according to allocated therapy.~   "
19842|NCT02796456|"~     Background :~      Apelin and its receptor APJ have been implicated in pathologies including cardiovascular~     disease, diabetes and obesity. Little is known about the function of the apelinergic system~     during gestation.~      Objective :~      The main objective of this study is to compare apelinemia in fasting normal weight and obese~     women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).~      Strategy and method:~      A prospective research evaluating will be conducted to compare apelinemia in fasting normal~     weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).~      A third group will be created to check if gestational diabetes is not a confounding factor~     in obesity (group of obese women with gestational diabetes).~      Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.~      Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and~     to see if neonatal apelinemia is correlated to the child's weight and birth size and to the~     weight of the placenta.~      Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.~      Two days after delivery, obese and not obese women will be fasted and plasma and colostrum~     will be collected. Investigators will compare apelin levels in the colostrum between these 2~     groups and then investigators will try to see if apelin level is correlated in the colostrum~     and in maternal plasma.~   "
19843|NCT02796443|"~     Meta-analysis of randomized controlled trials and population based studies in acute~     cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several~     weeks later. The main problems in these studies are the exclusion criteria used, thus not~     reflecting the real world setting of acute cholecystitis. The purpose of this study is to~     demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no~     worse outcome in comparison with an early operation (within 72 hours after onset of~     symptoms).~   "
19844|NCT02797665|"~     This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune~     pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half~     of participants will receive corticosteroids alone, while the other half will receive~     corticosteroids with biliary stent at the beginning.~   "
19848|NCT02797613|"~     Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture~     without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects~     bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for~     AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The~     investigators study will use a restricted laboratory report requesting the physician to call~     the laboratory for culture results. The restricted report may reduce the rate of~     inappropriate treatment of AB.~   "
19849|NCT02797600|"~     The study hypothesis is that the increased incidence of cervical cancer observed in~     Appalachian women over their non-Appalachian counterparts is due in part to inherited and~     somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling~     pathway.~   "
19850|NCT02797587|"~     This study is a randomized controlled trial (RCT) to compare the effects of varenicline,~     cytisine, and nicotine replacement therapy (NRT) to reduce: 1) alcohol use and craving, 2)~     smoking; and 3) inflammation and risk for coronary heart disease (CHD) and mortality among~     400 HIV-infected Russians, with heavy alcohol consumption and tobacco use.~   "
19851|NCT02797574|"~     The purpose of this study is to investigate stress response pathways in tissues and~     melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and~     stress response activation in tissues and melanocytes from patients with vitiligo.~     Individuals with vitiligo will have punch biopsies to study stress response UPR activation~     and NF-κB signaling to test our hypothesis. In order to characterize differences between~     disease and normal states, a second arm of control individuals (Arm 2) will be recruited.~   "
19852|NCT02797561|"~     The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided~     Percutaneous Coronary Intervention in coronary tandem lesions.~   "
19853|NCT02797548|"~     The purpose of this study is to evaluate the safety and effectiveness of perioperative~     antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.~   "
19854|NCT02797535|"~     Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or~     colostomy bags or having an ileal pouch and who meet the eligibility criteria will be~     enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples~     will be collected from: (i) fluids suctioned during standard endoscopy procedures /~     pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from~     stool samples collected by patients after pouch surgery.~   "
19855|NCT02797522|"~     Normal healthy volunteers (NHVs) will enroll sequentially into a total of 6 escalating dose~     levels randomized to receive ARC-521 Injection or placebo.~      Hepatitis B e Antigen (HBeAg) negative Chronic Hepatitis B patients (CHBs) will enroll~     sequentially into a total of 3 dose levels to receive open-label ARC-521 Injection.~   "
19856|NCT02797509|"~     The current study has the following objectives:~        1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including~          their perceptions of the stroke experience, hospitalization, and how they cope with its~          challenges; identify additional appropriate points to intervene (maladaptive coping~          styles, unrealistic expectations, inappropriate prioritization, misinformation about~          illness, and self care), and assess SP and SC preferences for the structure, mode of~          delivery (including potential for phone, video or a combination of these) and timing of~          an intervention.~        2. To develop, [using the preliminary data and information from aim 1], and test the~          feasibility and acceptability (primary outcomes) of a skills-based intervention for~          preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.~   "
19857|NCT02797496|"~     Parkinson's disease is a major source of handicap, for which physical treatments are often~     underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments~     alone prove unable to stop or control the gradual worsening of motor disability after a few~     years.~      The training program that this study sets out to evaluate aims to restore balance between~     agonist extensors and antagonist flexors in Parkinson's disease.~      There is indeed in Parkinson's disease an imbalance between weak flexors and weaker~     extensors, with excessive predominance of the flexors. The hypothesis of the study is that a~     motor strengthening program targeting extensor muscles specifically will improve body~     posture and restore motor function better than a conventional physical therapy program, in~     mild to moderate Parkinson's disease.~      This is a parallel-group, single blind, randomized trial (investigators will be kept unaware~     of the physical treatment followed by study subjects).~      The duration of patient participation is 5 months: 2-month intervention and 3-month~     follow-up following the intervention.~   "
19858|NCT02797483|"~     There is existing evidence to show that vegetable oils having unsaturated fatty acids in the~     sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1~     and sn-3 positions of fat molecules do not raise serum cholesterol levels. These~     observations have come to be known as or explained by the sn-2 hypothesis. New evidence~     have also emerged to show that saturated fatty acids (C16:0, C18:0) in the sn-1 and -3~     positions reduces fat deposition in a rat model. Therefore, further studies in humans are~     warranted to confirm these earlier findings.~      Fats and oils are made up of >90% triacylglycerol (TAG)- fat molecules which consist of a~     glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty~     acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Early evidence~     shown that the unique stereospecificity of fatty acid distribution on the palm fat molecule~     conferred health benefits in that it inhibited experimental atherosclerosis in the rabbit~     model.~      In vegetable oils, oleic acid [a monounsaturated fatty acid (MUFA)] is predominantly~     situated at the sn-2 position, while in animals fats it is predominantly palmitic acid or~     stearic acid (C16:0 or C18:0-saturated fat) that is situated there. Even though palm olein~     and lard have similar proportions of saturated fatty acid (SFA), MUFA and polyunsatuared~     fatty acid (PUFA), they differ significantly in their positional distribution on the TAG~     molecule. Palm olein TAG contains only 7-11 % palmitic acid at the sn-2 position while about~     87% is unsaturated fatty acids (oleic acid and linoleic acid). Lard has the highest amount~     of palmitic acid in the sn-2 position at 70%. On the other hand, in human milk, palmitic~     acid is predominantly in sn-2 (53-57 %) while cow milk fat contains less palmitic acid (38~     %) there. It is now believed that the distribution of fatty acids in the TAG is more~     important than the fatty acid composition alone in conferring the oils' 'saturated' or~     'unsaturated' properties.~      In this proposed study, the effects on the outcome measures investigated of different fatty~     acids (palmitic acid, oleic acid, linoleic acid) at the sn-1, sn-2 and sn-3 positions of the~     TAG molecule in three different test fats will be investigated.~   "
19859|NCT02797470|"~     This phase I/II trial studies the side effects and best dose of gene therapy in treating~     patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to~     therapy or came back after an original response receiving stem cell transplant. In gene~     therapy, small stretches of deoxyribonucleic acid (DNA) called anti-HIV genes are~     introduced into the stem cells in the laboratory to make the gene therapy product used in~     this study. The type of anti-HIV genes and therapy in this study may make the patient's~     immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with~     HIV-1.~   "
19860|NCT02797457|"~     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy~     and the quality of life of patients, social and familial exclusion, and dependence on third~     parties for everyday activities.~      The management of these patients is nearly exclusively through the use of prostheses.~     Certain patients refuse this solution, or remain penalized by the absence of sensitivity ,~     the lack of precision in movements, and body image issues related to the amputation; the~     double graft of hands and forearms may, in this circumstance, be the only solution.~      Since January 2000, date of the first double hand graft, six bilateral grafts of hands have~     been performed at the Hospices Civils de Lyon. This first study reported the feasibility of~     the graft. The functional results obtained after the double transplant have allowed patients~     to recover complete autonomy for everyday activities, at the price of an immunosuppressive~     treatment. We have found that these very good functional results are maintained over time~     and, for a certain number of patients, to return to work which is a factor of social~     integration.~      The rate of medical complications (metabolic, infectious, oncological), essentially related~     to the immunosuppressive treatment, is not greater to that found for other types of graft,~     but are considered as a limiting factor for the development of this strategy. These results~     are confirmed by international experience that is of the same order. Only a few rare cases~     of re-amputation have been reported in patients for whom the immunosuppressive treatment was~     discontinued or following vascular thrombosis.~      A new study is required to continue this evaluation and to compare double graft to~     prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social~     integration. The results of this study will allow the placement of these strategies in the~     management of patients with double amputation of the hands and forearms.~   "
19861|NCT02797444|"~     Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person~     with decision-making capacity makes decisions regarding their future health and/or personal~     care in the event that they become incapable of consenting to or refusing treatment' Most~     Canadians have not planned for end-of-life Care and are at risk of aggressive medical care~     that may not be compatible with their wishes. This study aims to systematically evaluate~     local barriers to making personal choices with regards to life support interventions that~     can be provided in the contemporary Intensive Care Unit.~   "
19862|NCT02797431|"~     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing~     frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte~     counts in sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis~     patients).~      A parallel study will be performed in United State of America to allow a common statistical~     analysis of the primary end points and analysis for the enrolled patient population.~   "
19863|NCT02797418|"~     Holders children with intellectual disabilities have great difficulty in adapting to social~     situations and relationships.Cognitive impairment associated with intellectual disability~     are important factors to understand their difficulties in processing social information. In~     the field of recognition of facial emotions in particular, basic cognitive processes such as~     visuospatial and attentional functions, are heavily involved.Cognitive remediation is a~     management tool widely used by practitioners to help patients who experience cognitive~     difficulties. Currently, no program can meet specific and validated the problems are~     children with intellectual disabilities manner in their daily functioning.~   "
19864|NCT02797405|"~     THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the~     predictive value of the A & MS bioassays on tumor control by radiotherapy.~   "
19865|NCT02797392|"~     The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD~     is a major health problem in developed countries and is mainly caused by an unhealthy~     lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking,~     obesity and physical inactivity, and increasing rates of obesity and physical inactivity in~     combination with smoking will lead to an increase in the number of patients with lifestyle~     related diseases in the coming decades. There is, therefore, an urgent need to identify and~     establish strategies and to implement interventions, allowing for the identification and~     management of citizens at increased risk of disease.~      Two recent systematic reviews of general practice based health checks suggest that people at~     increased risk of a chronic disease may benefit from a targeted approach to health checks.~     Targeted or selective preventive actions are a generally accepted and well integrated part~     of the health care system (e.g. treatment of hypertension and hyperlipidemia). However,~     selective prevention is challenged in terms of how to identify citizens at increased risk of~     disease in the general population in order to start the indicated preventive actions.~      The aim of the present pilot study is to test the acceptability, feasibility and short-term~     effect of a selective preventive program that systematically helps citizens evaluate~     individual risk of lifestyle related disease and offers targeted and coordinated preventive~     services in the primary health care sector.~      The intervention comprises four elements: 1) Systematic collection of information on~     lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk~     groups based on questionnaire data and information from the electronic patient record (EPR)~     using validated risk estimation models, 3) An individual electronic health profile with~     personalized advise on lifestyle change and 4) targeted preventive services at the general~     practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens~     with risk behavior, respectively.~      The intervention is supported by a patient-centered health information system that~     facilitates informed patient action and integrates general practice and municipality health~     care providers.~   "
19866|NCT02797379|"~     The purpose of this pilot intervention trial is to assess the efficacy of newly developed~     psychoeducation guides designed to manage anxiety in Autism Spectrum Disorder (ASD) by~     recruiting 30 participants with ASD and high levels of anxiety along with their~     parent/caregivers who both receive a version of the psychoeducation guide.~   "
19867|NCT02797366|"~     Open label, multi-centre prospective study. Adult patients with primary central nervous~     system tumours fulfilling the inclusion criteria according to the study protocol. The study~     consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and~     toxicity, as well as long-term survival data, when using spot scanning proton beam therapy.~   "
19868|NCT02797353|"~     The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a~     dismal pictures and after the floods of 2010-2011 the health infrastructure of this district~     was badly affected. Aga Khan University Pakistan is intending to implement a service~     delivery project for the improvement of Maternal Neonatal and Child health situation through~     evidence based MNCH interventions.~   "
19869|NCT02797340|"~     The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and~     chronic state in relation to metformin transporter genotypes. Participants have heart~     failure and type 2 diabetes treated with metformin.~      Hypothesis:~      Primary: The renal clearance of metformin is decreased in acute state of congestive heart~     failure compared with chronic state.~      Secondary: Metformin trough values in HF patients are influenced by polymorphisms in~     transporter genes relevant to the pharmacokinetics of metformin.~   "
19870|NCT02797327|"~     The primary goal of the study is to identify biomarkers from the molecular signature~     predictive of pre-term birth. This will be achieved through high frequency sampling and~     profiling throughout pregnancy.~   "
19892|NCT02797041|"~     This observational, non-interventional, retrospective, multicenter, national study focuses~     on collecting information about the effectiveness and safety of bortezomib re-use at first~     relapse in MM patients already treated in their first line with a bortezomib-based regimen,~     re-challenged with the same drug according to current clinical practice and/or Italian~     SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.~      Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in~     Italy. Approximately, data of up to 100 patients will be collected.~   "
19871|NCT02797314|"~     Patients with type 2 diabetes have many complications in different organs. These~     complications are extremely frequent and severe: cardiovascular and renal disease, visual~     impairment, and, more recently, complications affecting bone such as fractures. Conventional~     methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or~     FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the~     context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in~     patients with type 2 diabetes compared to patients not suffering from this disease,~     independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a~     high BMD has led to the hypothesis that diabetes induces a modification of the quality and~     not the quantity of bone. However, there is a lack of data as to bone quality in patients~     with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are~     extremely rare.~      The objective of the study is to compare bone quality in patients with type 2 diabetes to~     that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures~     by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone~     quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and~     analysis of mineralization).~      The results will then be correlated with blood/urinary markers with the objective to~     determine one/several non-invasive biomarkers for bone status in diabetic patients.~   "
19872|NCT02797301|"~     This study was to develop a computerised test with an adapted peripheral to assess the~     emerging literacy knowledge of children with mobility difficulties. The software was~     implemented using a game-like design controllable by a peripheral device without needing~     fine movements.~   "
19873|NCT02797288|"~     The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by~     identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would~     protect the gut from damage. This could lead to new and effective approaches to the~     treatment or prevention of Clostridium difficile colitis that act downstream of fecal~     microbiota transplants (FMT) or next generation probiotics. Successful fecal transplantation~     will restore Interleukin-25, Interleukin-4 and eosinophils to the colon~   "
19874|NCT02797275|"~     Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in~     nonsmokers. Flight attendants who worked on commercial aircraft before the ban on tobacco~     smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a~     unique population for the study of long-term health effects of chronic exposure to SHS.~      In previous studies, we have shown that many never-smoking SHS-exposed FAs to have~     curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static~     air trapping (elevated residual volume to total lung capacity ratio [RV/TLC]), abnormalities~     that are not diagnostic of overt COPD, but do implicate the presence of an obstructive~     ventilatory defect, and are consistent with what has been recently described as preserved~     ratio impaired spirometry (PRISm).~      The main objective of the study is to determine the effect of a bronchodilator to counter~     the physiologic abnormalities that are observed in the population of never-smoking~     SHS-exposed FAs as both proof of concept of the presence of an obstructive lung disease and~     as a possible therapeutic option to counteract the adverse respiratory effects of chronic~     exposure to SHS.~   "
19875|NCT02797262|"~     Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to~     manageable disease but adherence to ART remains critical to optimize outcomes. Existing~     measures of ART adherence provide only inferred measures of actual drug intake and most~     offer no real-time notification capability. Directly observed therapy measures actual drug~     intake but is not practical. These limitations constrain research into medication adherence~     and more importantly, limit our ability to develop real-time interventions based on~     feasible, in vivo monitoring of adherence among HIV-infected people to facilitate~     medication-taking. The Proteus digital health feedback (PDHF) system, a pill ingestible~     sensor based adherence measuring and monitoring system developed by Proteus Digital Health,~     addresses these limitations. It involves use of an ingestible sensor, a tiny edible material~     that is over-encapsulated along with prescribed medication. The sensor is activated by~     ingestion and is sensed by a patch worn by the patient with an embedded monitor and sensor.~     The monitor sends a Bluetooth signal to a mobile device, which in turn sends an encrypted~     message to a central server, thus effecting real-time monitoring that a dose has been taken.~     The investigators propose to develop a data receiving hub and add to these components an~     automated text message that is sent to the patient when a dose is missed. The investigators~     will evaluate the feasibility, acceptability and sustainability of using the PDHF system;~     assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the~     efficacy of the PDHF system for monitoring and leveraging adherence to ART.~   "
19876|NCT02797249|"~     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over~     the world. The use of low dose aspirin has been mentioned in several studies with promising~     results. The investigators decided to evaluate the use of low dose aspirin in Chinese~     pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical~     characteristics aiming to reduce the incidence of preeclampsia.~   "
19877|NCT02797236|"~     This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose~     escalation (two doses), placebo-controlled study in healthy volunteers.~   "
19878|NCT02797223|"~     The main objective of this qualitative phenomenological study is to understand the impact of~     chemotherapy-induced alopecia, the quality of life of women with breast cancer from this~     experience.~      The study will be conducted in the day hospital oncology-hematology of the Hospital de la~     Santa Creu i Sant Pau. Data collection will be done through semi-structured interviews.~     About 12 to 14 interviews throughout the study was conducted. So in the study involved a~     total of between 12 and 14 women.~      These will be recorded in voice and then transcribe and code. From reading and re-reading~     the patterns or data that relate to each other, thus establishing the categories (thematic~     analysis) were identified. These categories describe the experiences of the participants~     alopecia.~   "
19879|NCT02797210|"~     This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major~     depression. The trial will include structural and functional MRI, EEG, and behavioral~     measures obtained before, during, and after treatment.~   "
19893|NCT02797028|"~     The purpose of this study is to confirm the protective effect and mechanism of anthocyanins~     on hyperuricemia patients with Cardiovascular disease.~   "
19880|NCT02797197|"~     Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or~     performance). There is a high prevalence in elderly and in patients with cancer. Several~     mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process,~     hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in~     several studies where sarcopenia appeared to be an independent factor of mortality, and~     associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and~     chemotherapy toxicities.~      Diagnosis is based on the measure of the muscle mass performing an abdominal~     computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip~     test with a Jamar® hydraulic hand dynamometer. CT scan is more invasive and less easy to~     reach than handgrip test. This test is used to be performing in elderly but not in cancer~     patients having chemotherapy. Present prospective study explored the feasibility of~     systematic handgrip strength testing and short-term changes in muscle strength in digestive~     cancer patients treated by chemotherapy.~   "
19881|NCT02797184|"~     The purpose of this study is to do the work that is necessary and sufficient for setting up~     an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart~     failure: inorganic nitrate. The investigators will first determine the effects and~     palatability of ~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount~     of nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the~     investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format)~     on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise~     performance in a dose-response study. Third, the investigators will perform a small phase II~     chronic treatment study that will allow them to determine the best primary endpoint and the~     numbers of patients the investigators will need to study in the large, multi-center RCT to~     follow this project. In the small study and in the RCT to follow, the investigators will~     determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and~     speed of muscle contraction, and lessen the effort of breathing during exercise.~   "
19882|NCT02797171|"~     This study will evaluate the safety, pharmacokinetics, and antiviral activity of~     VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of~     healthy, HIV-uninfected adults.~   "
19883|NCT02797158|"~     Evaluation of a strategy of selected revascularization guided on myocardial ischemia~     detection after the TAVI procedure by using single photon emission computed tomography~     (SPECT) myocardial perfusion imaging.~   "
19884|NCT02797145|"~     Digoxin was approved for heart failure treatment in 1998 according to current regulations~     made by Food and Drug Administration (FDA), based on the following clinical trials: The~     Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED),~     Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme~     (RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of~     ventricular response rate in atrial fibrillation patients.~      Several clinical trials with digoxin provided convincing evidence that support the digoxin~     use heart failure (HF) treatment of symptomatic patients. PROVED trial was a~     placebo-controlled, twelve weeks duration study. This study included patients with decreased~     systolic function, sinus rhythm and heart failure stable symptoms, these patients were using~     digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure~     worsen, reduction of exercise capacity and also a reduction of left ventricle ejection~     fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE~     followed a similar protocol; however the patients used ACE inhibitors besides digoxin and~     diuretics. The digoxin removal was associated with a six times worsen of heart failure,~     despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the~     functional capacity, life quality and in the ejection fraction on the digoxin removal~     patients' group.~   "
19885|NCT02797132|"~     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the~     pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of~     Lumacaftor/Ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with Cystic~     Fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in~     Part B, if patient meet the eligibility criteria.~   "
19886|NCT02797119|"~     TRACES trial is a multicenter randomized double blind placebo control therapeutic and~     pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a~     single intravenous infusion of two doses regimens (standard dose and low dose) of TA~     administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and~     to correlate this clinical effect with the biological effect of fibrinolysis inhibition and~     the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.~   "
19887|NCT02797106|"~     The study is a transversal, observational, descriptive survey of the practices and opinions~     of health professionals carried out nationally across France that aims to characterize~     children with cerebral palsy and pathological drooling and to describe care pathways,~     assessment and treatment of drooling.~   "
19888|NCT02797093|"~     The purpose of this study is to evaluate the relationship between anti-retroviral therapy~     (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual~     viremia in suppressed, HIV-infected individuals on chronic ART.~   "
19889|NCT02797080|"~     The purpose of this long term extension study is to evaluate the long-term safety of~     ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).~   "
19890|NCT02797067|"~     The purpose of the study is to determine whether rectal indomethacin reduces the incidence~     of post-ESWL pancreatitis.~   "
19891|NCT02797054|"~     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination~     among the Hispanic population. The objectives/aims of this HPV educational intervention~     project are:~        1. To measure the quality of the HPV vaccine decision among participants in different arms~          of the intervention~        2. To determine patterns of intervention utilization among participants in different arms~          of the intervention, and~      The implementation of this educational intervention in clinic waiting rooms is intended to~     assist primary care providers in communicating HPV vaccine awareness and education to~     parents and patients in a culturally tailored format.~   "
19894|NCT02797015|"~     The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of~     RPC1063 in RMS.~   "
19895|NCT02797002|"~     Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's~     societies. Cervical muscles endurance has been commonly associated with the development of~     NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical~     therapists to evaluate muscle structure, function and activation patterns. The aim of this~     study is if change in muscle thickness can correlate with the results of the endurance~     testing.~   "
19896|NCT02796989|"~     During this project the effect of modified wheat bran on colon health and systemic health~     will be evaluated in a long-term intervention study in healthy and obese subjects.~   "
19897|NCT02796976|"~     The aims of the study are twofold. In the cross-sectional approach (Part I), the study will~     be conducted in an older population to assess the association of physical fitness on~     different parts of the human vascular bed. In the interventional approach (Part II), it aims~     to investigate whether and to what extent advanced vascular ageing (AVA) in older subjects~     with increased cardiovascular risk can be reversed by regular walking- based high intensity~     interval training.~   "
19898|NCT02796963|"~     The purpose of this stepped wedge randomized controlled trial is to evaluate the~     effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese~     men who have sex with men (MSM). The crowdsourced intervention will include an open contest,~     judging to determine finalists and prizes, a designathon, and contest-based MSM engagement.~     The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test~     uptake campaigns in eliciting HIV test uptake.~   "
19899|NCT02796950|"~     Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine~     stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used~     in the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of~     GLP-1 are increased in response to acipimox. The hypothesis is that G protein coupled~     receptors on enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.~      In a controlled, open, randomized experiment, eight healthy, overweight men will be studied~     on an intervention day, where they receive acipimox, and on a control day. The study day~     includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and~     a biopsy from adipose tissue.~   "
19900|NCT02796937|"~     This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled~     GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data~     for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin~     deficiency.~   "
19901|NCT02796924|"~     The purpose of this study is to investigate the feasibility of using repetitive transcranial~     magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the~     frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.~   "
19902|NCT02796911|"~     Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment~     time. The current study will be carried to evaluate the effectiveness of different bone~     grafts with a modified, less invasive corticotomy technique in the treatment of adult~     patients with moderate crowding.~      Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly~     classified into three groups. Group I will be treated with a modified technique of~     corticotomy, whereas group II will be treated with the same technique combined with PAOO~     using bovine derived xenograft, and group III will be treated with the same technique~     combined with PAOO using with bioactive glass. The total duration of active orthodontic~     treatment will be estimated. Probing depth, bone density and root length will be also~     evaluated. The measurements will be recorded.~   "
19903|NCT02796898|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88~     in patients with prostate cancer~   "
19904|NCT02796885|"~     Hypophosphatasia (HPP) is an inherited condition which causes a defect in bone~     calcification, leading to weak bones. Early childhood forms are severe and easily~     recognised, and there is now a drug treatment which is very effective in children.~      Adult forms are milder, often missed by doctors or confused with osteoporosis. This is~     important because the usual osteoporosis treatments may be harmful in HPP, and increase the~     risk of broken bones. One of the reasons it is missed is a lack of research describing the~     typical features of HPP, so doctors don't recognise the signs, and don't know when or how to~     test for it.~      The aim of this study is to establish clear criteria (from clinical history, examination and~     blood tests) to identify people with HPP. The results will also determine if there should be~     a trial of drug treatment for adults with HPP.~   "
19905|NCT02796872|"~     This survey is a multicenter, double-blind, randomized, controlled, parallel-designed,~     prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance,~     gut health, fecal flora and immune function.~   "
19906|NCT02796859|"~     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy~     of Siltuximab (Sylvant) as an adjunct to antipsychotic medications in stable outpatients~     with schizophrenia. Siltuximab (structural formula C6450H9932N1688O2016S50) is a recombinant~     chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody. Siltuximab is~     formulated as a concentrate for solution for infusion, and will be administered by~     intravenous infusion.~      The investigators propose a 9-week randomized controlled trial of siltuximab, given in~     adjunct to antipsychotics, in N=30 stable outpatients with schizophrenia or schizoaffective~     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity~     C-reactive protein [hsCRP] >0.5 mg/dL). The investigators hypothesize that adjunctive~     treatment with siltuximab will be associated with significant improvement in cognition~     compared to placebo in patients with schizophrenia, baseline IL-6 levels are higher in~     siltuximab-treated responders versus non-responders, and there will be greater decreases in~     hsCRP from baseline to week 6 in siltuximab-treated versus placebo-treated responders, with~     response defined as ≥0.5 SD improvement in cognition. Siltuximab is administered as an~     intravenous infusion every 3 weeks. Following a screening evaluation, participants will~     receive three infusions of siltuximab, one at baseline, another at week 3 of the study, and~     another at week 6. The investigators will measure changes in cognitive function and symptoms~     over a 9-week period. Complementing previous positive clinical trials of non-steroidal~     anti-inflammatory drugs, this would be a proof-of-concept study that targeting specific~     cytokines is a viable treatment for schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. Janssen Pharmaceuticals, Inc. began the clinical~     development of siltuximab for the treatment of multicentric Castleman's disease, a rare~     blood disorder. Other clinical studies with siltuximab have been conduced for patients with~     B-cell non-Hodgkin's lymphoma, multiple myeloma, and ovarian cancer.~      In April 2014,siltuxiumab was approved by the U.S. Food and Drug Administration (US FDA) as~     Sylvant for human immunodeficiency virus (HIV)-negative and human herpesvirus-8~     (HHV-8)-negative multicentric Castleman's disease.~   "
20087|NCT02794259|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in older~     people, compared to sham tDCS.~   "
19907|NCT02796846|"~     The purpose of this study is to evaluate the pre and postoperative CPAP compliance rate in~     OSA surgical patients with or without a CPAP prescription. In this study, all diagnosed OSA~     patients with or without a CPAP prescription will be approached for informed consent to~     enroll in the study. Documented OSA is defined as an OSA diagnosis based on a previous~     laboratory or portable PSG, or on the prescription of CPAP for OSA. The patients with a CPAP~     prescription will be followed up to determine their compliance with CPAP and data will be~     collected to determine the O2 saturation. Those patients with diagnosed obstructive sleep~     apnea without a CPAP prescription will also be followed to objectively determine the~     severity of OSA which would indicate whether they do not require CPAP owing to their mild~     OSA or they in fact may require CPAP due to change in weight etc. Preoperative overnight~     oximetry will be performed on all the OSA patients at home before surgery. In the~     postoperative period, all patients will be followed up with a nocturnal oximetry in the~     first two post-operative nights of hospital stay. Postoperative compliance to CPAP will be~     evaluated and recorded in all the patients. The patients' charts will be reviewed for any~     postoperative complications. The clinical management of patient will be left to the~     discretion of the perioperative care team.~   "
19908|NCT02796833|"~     Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required~     when the gastrointestinal tract is not able to function properly. TPN contains~     carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. The~     lipid that is currently used at the University Health Network home TPN program is~     Intralipid20%, which is based on Soybean oil, contains polyunsaturated fats and is a good~     source of energy and essential fatty acids, including omega 3 and 6 fatty acids, which~     needed by the body. However, long term use on Intralipid20% has been shown to have negative~     effects on antioxidant status, inflammation, liver, and the immune system.~      SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to~     omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with~     Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has~     positive benefits on the liver enzymes. There are no studies so far which follow patient who~     is on SMOFlipid20% long term. The investigators hope to show that with long term use of~     SMOFlipid20% is better for liver function compared to Intralipid20%.~   "
19909|NCT02796820|"~     A randomized, paralleled control clinical study investigating Huaier Granule for prevention~     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the~     efficacy and safety.~   "
19910|NCT02796807|"~     Prostate cancer is the second leading cause of cancer death in North American men older than~     50 years. Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein,~     which is overexpressed manifold on prostate cancer cells and is well-characterized as an~     imaging biomarker of prostate cancer. Positron emission tomography / computer tomography~     (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from~     radiolabeled tracer molecules. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a~     tracer for prostate cancer PET imaging. The strength of functional imaging methods is in~     distinguishing tissues according to metabolism rather than structure. Studies have shown~     that PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent~     contrast and a high detection rate even when the level of prostate specific antigen is low.~      Study Objectives:~      The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA PET/CT in~     locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at~     initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.~     This is of interest because non-invasive risk stratification may be possible in the future.~      This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will~     be performed on study participants. A PET/CT scan takes 2-3 hours.~   "
19911|NCT02796794|"~     To evaluate effects of genistein supplementation to enteral nutrition on inflammatory~     cytokines and morbidity in patients with sepsis~   "
19912|NCT02796781|"~     Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium.~     The lung scarring that occurs in ILD is often irreversible with only mitigating therapy~     available so far. This study intends to carry out an open, single-armed, phase I/II clinical~     trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the~     treatment, lung stem cells will be isolated from patients' own bronchi and expanded in~     vitro. After careful characterization, cultured cells will be injected directly into the~     lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be~     monitored by measuring the key clinical indicators.~   "
19913|NCT02796768|"~     Ultrasound imaging (US), a radiation-free imaging modality, is currently used in diagnosis~     of developmental dysplasia of the hip (DDH) in infants. The current protocol involves~     manually identifying specific measures that are prone to error, and may give rise to false~     positives. We aim to use 2-dimensional (2D) and 3-dimensional (3D) ultrasound imaging to~     create an automatic measurement procedure that we hope will reduce the errors in measurement~     and increase reliability.~   "
19914|NCT02796755|"~     The goal of the proposed research is to determine whether riluzole, a drug that increases~     glutamate reuptake, will decrease CNS glutamate in breast cancer survivors with increased~     inflammation and fatigue. We will also determine whether decreasing glutamate with riluzole~     will reverse inflammation-related fatigue and other symptoms including cognitive dysfunction~     and decreased motivation. To accomplish these goals, we plan to conduct an 8 week,~     double-blind, randomized control trial of riluzole (100 mg/d) versus placebo in 40 breast~     cancer survivors (n=20 per group). All breast cancer survivors will have completed treatment~     within 1-3 years and have a fatigue level of ≥4 (on a 10 point scale) and a plasma~     c-reactive protein (CRP) concentration >3mg/L (indicative of high inflammation). Patients~     will undergo magnetic resonance spectroscopy (MRS) to measure CNS glutamate before and after~     2 and 8 weeks of riluzole or placebo treatment. Fatigue and other behavioral assessments~     including measures of cognitive function and motivation will be conducted before and after~     treatment and correlated with the change in CNS glutamate.~   "
19926|NCT02796391|"~     The purpose of this study is to see if targeted interventions will help people to stop or~     reduce smoking better than standard interventions using very low nicotine content (VLNC)~     cigarettes.~      This developmental pilot study (n=20) will determine the feasibility of the treatment~     approach and methodology, and lead to refinements for a subsequent randomized controlled~     trial (RCT).~   "
19915|NCT02796742|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative~     pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and~     soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran~     et al. 2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of~     MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the~     prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably~     due to the fact that culture and antimicrobial susceptibility testing is not a routine~     component of SSTI management.~      Setting-up a prospective multi-centre study involving patients presenting to emergency~     departments with SSTIs in several European countries would allow drawing a picture on the~     role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a~     cause of SSTIs. However, the roles of emergency rooms and local policies with regard to~     performing microbiological analysis after surgical drainage of SSTIs vary between countries.~      In order to evaluate the feasibility of such multicenter European study, we aim at~     performing a pilot study based on few European clinical laboratories (five to seven) which~     will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in~     community-acquired SSTIs; and ii) determine molecular characteristics of the isolated~     strains. The main objectives of this pilot study are to collect some preliminary information~     on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or~     taken into consideration for the set-up a larger prospective cross-sectional study involving~     more European countries with several centers per country to cover different geographical~     areas per country.~   "
19916|NCT02796729|"~     This project will compare two MRI contrast agents in metastatic brain tumours in humans.~     More specifically, the investigators will compare the tumour contrast obtained using glucose~     versus the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name~     Gadovist, will be used).~      First, participants will receive a glucose bolus injection followed by glucose enhanced MRI.~     Second, participants will receive a Gd-DTPA bolus injection followed by Gd-DTPA enhanced~     MRI. Both contrast studies will be performed during the same MRI study, which will be under~     one hour long.~   "
19917|NCT02796716|"~     This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that~     uses a digital microscope to identify bacteria based on their growth patterns. This method~     does not have to wait for bacteria to grow in a lab. The new method can identify the type of~     bacteria within 2 hours of receiving a specimen. The new method also shows the effect of~     selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors~     know within 6 hours from specimen collection which antibiotic kills the bacteria.~      To check the accuracy, speed and impact of the new method on antibiotic prescribing,~     investigators are proposing a study with two parts; The first part will test the accuracy~     and speed of the results obtained by the new method. The second part will test if having the~     results from the new method early would change the antibiotics prescribed to a patient in a~     simulation experiment. An independent infectious disease physician will be shown the results~     from the new method and asked if the results were accurate, would it change the antibiotic~     treatment for the patient.~   "
19918|NCT02796703|"~     Prophylactic probiotics have been shown to decrease the incidence of Necrotizing~     Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live~     bacteria to small babies. Based on animal data, the investigators hypothesized that heat~     inactivated probiotics would also reduce NEC.~   "
19919|NCT02796690|"~     The repeated exposition to S. aureus is considered as a determining factor of acquisition of~     the nasal colonization. The healthcare professionals are regularly in touch with this~     pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was~     the object of several studies but little took into account the respect for the rules of good~     hygienic practice. The results of our previous study carried out during the international~     congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association~     between the work in a hospital environment and the increase of the risk of nasal carriage.~     On the contrary, the use of the hydro-alcoholic solutions had a protective effect against~     this carriage. However, sized of the health care population of our study was limited.~      The goal of this study is to confirm our previous results on a larger cohort of healthcare~     professionals. The main objective is to estimate the prevalence of nasal carriage according~     to the professional category and by taking into account the degree of conformity with good~     hygiene practices including the use of hydro-alcoholic solutions.~   "
19920|NCT02796677|"~     This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and~     multinational Phase III study to determine the efficacy and safety of Aclidinium bromide~     400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO~     (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary~     disease (COPD).~   "
19921|NCT02796664|"~     The purpose of this study is to determine whether Ginseng is effective in the prevention of~     atherosclerosis and subsequent ischemic stroke.~   "
19922|NCT02796651|"~     To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg)~     twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized~     formoterol fumarate (20 μg and 40 μg).~   "
19923|NCT02796430|"~     This study will evaluate the ease of use of the new calorimeter (Quark RMR 2.0 (COSMED,~     Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e.~     Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as~     the stability and the feasibility of the measurements in various clinically relevant~     situations.~      Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as~     the measure of the ease of use of the calorimeter.~   "
19924|NCT02796417|"~     This study examined the efficacy of an integrative cognitive remediation program (REHACOP)~     to improve cognition, social cognition, clinical symptoms and functional outcome in patients~     with schizophrenia.~   "
19925|NCT02796404|"~     The current state of mobile communication and technology is a tool to support home programs~     for chronic disease management, useful to facilitate access to these types of programs,~     because the investigators could obtain telematics information about the parameters, reducing~     cardiovascular risk factors and cardiovascular morbidity and mortality.~   "
19927|NCT02796378|"~     Background. Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the~     most prescribed drugs in the world. More than 600,000 people in Denmark are taking statins~     on a daily basis, approximately 40 % of these are taking the medication without having any~     other risk factors for cardio-vascular diseases than elevated blood-cholesterol i.e. they~     are in primary prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk~     of developing diabetes when taking statins. This has led to an increased debate about the~     use of statins in primary prevention. Furthermore a large meta-analysis has shown that to~     prevent one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5~     years. These data suggest that more conservative use of statins to prevent CVD in otherwise~     healthy individuals at low risk for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which~     potentially can prevent a physically active lifestyle. The biomedical background of these~     side effects is not fully elucidated but it has been shown that there is a link to~     decreasing levels of an important enzyme, Q10, which plays a role in muscle energy~     metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prohibit) physical exercise training? Furthermore the~     following questions will be investigated:~      A. Does statin treatment cause:~        1. Decreased muscle strength?~        2. Skeletal muscle inflammation?~        3. Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?~      Re question A & B: If so, can physical training counteract this effect of statin treatment?~   "
19928|NCT02796365|"~     The purpose of this study is to identify patients at risk for future heart failure using~     novel markers of early cardiac damage and determine if exercise training can improve these~     emerging markers as well as overall fitness and quality of life.~   "
19929|NCT02796352|"~     This study is for patients with advanced stage III or stage IV melanoma not adequately~     treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The~     purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression~     on nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is~     also being done to look at the severity of side effects of IL-2 in patients.~      IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of~     advanced melanoma.~   "
19930|NCT02796339|"~     The purpose of this study is to assess the effectiveness of a supplement with natural~     Mastiha on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has~     classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as~     anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European~     Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to~     the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders,~     skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease~     characterized by inflammation and oxidative stress and based on previous small-scale~     studies, the present study aims at demonstrating the effectiveness of this supplement~     adjunct to the conservative treatment of IBD.~      To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's~     Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff~     of the study will provide detailed information regarding the aims, the methods, anticipated~     benefits and potential hazards of the study and all patients will receive the Patient~     Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether~     they want to participate in the protocol. Each patient agreeing to participate will sign an~     Informed Consent document and the staff will explain to patients that they are under no~     obligation to enter the trial and that they can withdraw at any time during the trial,~     without having to give a reason. A copy of the signed Informed Consent will be given to the~     participant.~      100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group~     will receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will~     receive respectively placebo. The intervention will last 3 months for patients in relapse~     and 6 months for patients in remission. They will receive all the supplements they will~     consume during the intervention at the start of the trial. Both groups will continue their~     medical treatment, which must be unaltered throughout the trial. Additionally, all patients~     will receive standard nutritional advice by dieticians and will be encouraged to report any~     adverse effects they may experience during the intervention. The trial will be blinded in~     all implicated persons; neither the staff of the trial nor the patients will be aware of~     which kind intervention they receive.~      Patients are assessed after randomisation according to the following tools:~        -  Medical history~        -  Dietary history~        -  Harvey & Bradshaw Activity Index Assessment~        -  Mayo Activity Index assessment~        -  Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2)~        -  Inflammatory Bowel Disease Questionnaire~        -  DNA isolation from whole blood.~        -  Biochemical measurements: Complete blood count, albumin, lipid profile, glucose,~          electrolytes, liver enzymes, amylase, fibrinogen.~        -  Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8,~          IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are~          measured), in all active CD and UC patients. Inflammatory markers are also estimated in~          stool samples: calprotectin, lactoferrin and lysozyme,~        -  Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability~          and F2-isoprostanes are quantified.~        -  Detection of metabolites and complete metabolomic profile in plasma samples.~        -  Stool samples collection for the assessment of gut microbiota in active patients.~        -  Genetic and epigenetic profile~      Subsequent assessments: There is a biweekly telephone contact with the patients to monitor~     compliance and side effects. At the end of the intervention each subject undergoes the~     baseline assessment.~   "
19931|NCT02796326|"~     The purpose of the study is to prospectively assess the use of a modified tracheal balloon~     dilator that allows gas flow (oxygenation and ventilation) through the device while inflated~     during dilatation.~   "
19932|NCT02796313|"~     We will conduct a randomized trial to test this program in 400 adult American Indians with~     inadequately controlled systolic blood pressure (140-159 mmHg). Over the 5 years of the~     project, we will recruit and randomize 200 participants from each of 2 urban sites: Spokane,~     Washington, and Tulsa, Oklahoma. The intervention group will receive advice from a dietician~     on adopting the DASH diet (Dietary Approaches to Stop Hypertension), and ongoing~     professional guidance throughout the 8 week intervention period, along with a weekly $30~     credit for groceries that is restricted to DASH-compliant foods. The control group will~     receive printed educational materials with general information about low-salt diets plus a~     weekly $30 credit for groceries without restrictions on food choices. Our primary outcome is~     systolic blood pressure measured after the 8 week intervention and again at week 12. In~     addition, we will conduct a pilot study among 100 intervention participants after the~     intervention concludes by randomizing half to receive 6 extra weeks of dietician support and~     half to receive no further support.~   "
19933|NCT02796300|"~     Numerous catheter designs have been studied to increase efficacy and minimize complications~     of catheter hemodialysis. Major complications of catheters include thrombosis, central~     venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible~     because using too many catheters may exhaust all of the catheter insertion sites on the~     body, as well as increase the risk of infection. This prospective study compares the~     complications and general outcomes of patients who receive hemodialysis using the mainstream~     Palindrome catheter versus the newer BioFlo DuraMax catheter.~      This study will examine outcomes of patients who receive hemodialysis using either the~     Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be~     recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions~     on which catheter produces less catheter thrombosis.~   "
19934|NCT02796287|"~     The transient global amnesia (IA) is defined clinically as a temporary suspension and~     isolated from the ante and retrograde memory, totally regressing within 24 hours. The causes~     of AI remain unknown. The diagnosis of IA is based on consensus clinical criteria including~     the absence of associated location marks. In clinical practice, the MRI is often performed~     in conjunction with clinical examination because it ensures the absence of differential~     diagnoses, including stroke.~      The visualization of MRI signal abnormalities related to AI directly dependent on the~     completion time of the review in relation to the onset of symptoms. Typically, no signal~     abnormality is visible in the hyperacute phase (ie D0-D1) while punctate appear hyperintense~     on diffusion sequences in hippocampal structures from J2 to J7 to disappear completely. It~     has been previously demonstrated that the use of higher values of b and / or a better~     spatial resolution significantly increases the sensitivity of the broadcasting sequence for~     the detection of these abnormalities hippocampal signal. At St. Joseph Hospital,~     Investigators explore the AI suspected patients with diffusion tensor sequence (DTI) on our~     high resolution 3T MRI.~      Compared to the classical diffusion sequence, DTI is characterized by the use of a greater~     number of directions in which the diffusion gradients are applied. One advantage of this~     technique is to be able to perform tractography of white matter fibers. Thus the~     connectome is a new technique for post-processing of DTI images based tractography and to~     assess all the networks of nerve fibers in the brain. By this technique, the values of~     average diffusivity (MD) and fractional anisotropy (FA) can be measured along each of the~     studied nerve fibers. Group studies thus become feasible to compare quantitatively healthy~     subjects and patients groups in terms of structural differences within the connectome. The~     contribution of this technique was recently highlighted in patients with temporal lobe~     epilepsy.~   "
19935|NCT02796274|"~     The purpose of this survey is to collect visual acuity data from patients with LHON in order~     to establish the clinical course (natural history) and visual acuity outcomes in patients~     with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data~     that will serve as comparator for the open-label study SNT-IV-006.~   "
19936|NCT02796261|"~     The purpose of this study is to compare the efficacy and safety of eflornithine in~     combination with lomustine, compared to lomustine taken alone, in treating patients whose~     anaplastic astrocytoma has recurred/progressed after radiation and temozolomide~     chemotherapy.~   "
19950|NCT02796079|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic~     foot.This study intends to establish an optimal clinical research program, and attempts to~     break the technical bottleneck in the stem cell therapy for treating diabetes related~     vascular complications.~   "
19951|NCT02796066|"~     The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical~     gel in the treatment of moderate to severe acne.~   "
19952|NCT02796053|"~     Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08~     during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled~     with current therapy.~   "
19937|NCT02796248|"~     Stigma related to chronic disease is rejection or judgement or exclusion by others that is~     related to the chronic disease itself and is unwarranted. We are trying to figure out what~     proportion of young people with type 1 diabetes experience stigma in Canada. By young~     people, we mean teenagers and young adults; specifically, people who are between 14 and 25~     years of age. This is a challenging period in life when identities are developed and peer~     opinions are felt to be particularly important. Experiencing stigma in this life period may~     be especially hurtful and may have bad effects on taking care of type 1 diabetes. This may~     lead to important medical problems like dangerously low or high blood sugar values. By~     understanding how common stigma is, we can figure out the need for programs and strategies~     to deal with it.~      We will ask young people with type 1 diabetes to help us study this problem by completing an~     online survey. We will 'advertise' our study through type 1 diabetes clinics, websites, and~     social media. People who are eligible and interested will click on an internet link and be~     directed to the survey. Staff at clinics in Montreal, Calgary, and Vancouver will also draw~     their attention to the posters and/or provide small flyers with the internet link for the~     study.~      Participants will be asked about their general sense of well-being, their habits and~     behaviours, and their blood sugar control, including frequency of both lows and highs. They~     will also be asked if they are willing to mail in a small blood sample. If yes, they will~     receive a kit with a small lancing device and instructions on how to clean their finger tip,~     prick it, and express a few drops of blood into a small container. They will then mail this~     back to us in a postage-paid envelope. We will use this to measure their hemoglobin A1c, an~     overall measure of blood sugar control.~      We will use this information to (1) calculate the proportion of young people with type 1~     diabetes who experience stigma; (2) figure out what factors and behaviours might predict or~     signal the experience of stigma; (3) see if there is a link between stigma and A1c control~     and/or frequent lows by report; (4) explore challenges and solutions voiced through the~     open-ended questions.~   "
19938|NCT02796235|"~     Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to~     80% against 10-20% in the general population.~      The risk of VTE is very important in the first weeks after spinal cord injury, and then~     declines with a prevalence of VTE slightly higher than the general population after 12~     weeks. However there is no prospective study of incidence of VTE in SCI patients after 3~     months. The investigators wish to conduct such a study during the year following spinal cord~     injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of~     the initial injuryassociated with a standardized clinical assessment, to know the incidence~     of VTE and determine prognostic factors for VTE.~   "
19939|NCT02796222|"~     Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended~     half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe~     hemophilia A and B, respectively. The objectives of this observational study is to describe~     the change in annual factor consumption, clinical and patient-reported outcomes for patients~     who switch from recombinant factor VIII (rFVIII) and recombinant factor IX (rFIX) to~     rFVIIIFc/ rFIXFc in Canada, and to explore clinicians' and patients' reasons for switching~     or not switching.~   "
19940|NCT02796209|"~     Atomoxetine, a selective norepinephrine transporter (NET) blocker, increases standing blood~     pressure and improves neurogenic orthostatic hypotension (NOH)-related symptoms to a greater~     extent than midodrine, the current standard of care. Atomoxetine could be a new therapeutic~     alternative for the treatment of NOH in patients with autonomic failure, particularly those~     with multiple system atrophy (MSA).~      The proposed study consists of an open-label, dose-optimization phase followed by a~     randomized, double-blind, placebo-controlled, 2x2 crossover phase.~   "
19941|NCT02796196|"~     This research trial studies prescribed physical activity in improving sleep and physical~     performance in patients undergoing stem cell transplant. A wearable physical activity~     monitor can be used to record minutes of activity and sleep. Gathering data over time using~     a physical activity monitor may help doctors learn if prescribed physical activity helps~     improve sleep and physical performance in patients undergoing stem cell transplant.~   "
19942|NCT02796183|"~     This study evaluates the effects of subconjunctivally injected bevacizumab in patients with~     diffuse diabetic macular edema.~   "
19943|NCT02796170|"~     To assess the effect of SGLT-2 inhibitors on blood pressure and urinary angiotensinogen.~     This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks~     followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6~     weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an~     open label as a comparative to the cross over subjects to assess if the effect of~     Dapagliflozin may also be in part due to improved glycemic control.~   "
19944|NCT02796157|"~     PCI of diffuse long coronary lesions still remains challenging because of relatively high~     risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The~     purpose of the study is to compare an incidence of composite of major adverse cardiovascular~     events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary~     intervention in long lesions more than 28 mm.~   "
19945|NCT02796144|"~     Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss~     in patients with schizophrenia, a population for which no current weight-loss treatments~     have gained widespread use. The goal is to recruit overweight people with schizophrenia to~     participate in a 52-week double-blind, randomized study to assess the efficacy and safety of~     lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight,~     body composition, and measures of glucose and lipid metabolism.~      Participants: Approximately 110 subjects will be enrolled at two clinical sites (UNC Chapel~     Hill and Columbia University)~      Procedures (methods): Behavioral: All participants will be offered a behavioral intervention~     of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This~     intervention will be provided at all in-person study visits after the Baseline Visit and~     supplemented with weekly interim phone calls to reinforce lessons between visits.~     Pharmacological Intervention: All participants who meet entry criteria will be randomized to~     one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).~   "
19946|NCT02796131|"~     A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in~     healthy volunteers.~   "
19947|NCT02796118|"~     The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151~     after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese~     subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and~     elderly male Japanese subjects.~   "
19948|NCT02796105|"~     Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus~     GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors~   "
19949|NCT02796092|"~     This prospective randomized study compares the safety and efficacy of two different~     embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils~     and vascular plugs.~   "
19953|NCT02796040|"~     Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological~     substrates of these symptoms are largely unknown.~      The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients~     with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging~     (DTI).~      More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data~     obtained with DTI) in the ventral tegmental area (VTA) is different between patients with~     ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume~     of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus~     accumbens, amygdala), and in number of fibers between VTA and the other structures of reward~     system between this two groups. Other objective is to measure and compare these same~     variables between Parkinson's patients and healthy controls.~      We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's~     patients to ICD.~   "
19954|NCT02796027|"~     Scaling up integrated, cost-efficient HIV services for people who inject drugs (PWID) in~     Needle Syringe Programs (NSPs) is urgently needed in Kazakhstan, where only one-third of the~     estimated 19,000 HIV-positive PWID are ever linked to HIV care and only 10% initiate ART~     with 4% achieving viral suppression. The study's aim is to evaluate the implementation,~     effectiveness, and sustainability of an integrated HIV service model in 24 NSPs located in 4~     Kazakhstani cities. This model will employ highly effective strategies that will include~     peer-driven recruitment of PWID in NSPs using social network strategies (SNS), integrating~     rapid HIV testing in NSPs with HIV Care Clinic nurses, and linking HIV positive PWID in NSPs~     to HIV care using the ARTAS (Anti-Retroviral Treatment and Access to Services) case~     management model. Findings will have important public health implications for improving HIV~     service delivery for PWID in the Central Asian region and other countries with injection~     driven epidemics.~   "
19955|NCT02796014|"~     The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different~     aspects of health-related quality of life in the relatives of the patients with various skin~     diseases. The preliminary validation of this instrument was performed for the Turkish~     population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete~     and score, and reliably help to evaluate the family members' quality of life.~      Psoriasis is a chronic disease which can be expected to have a significant impact on the~     quality of life of the patients and parents/family members alike. In line with this~     assumption, previous studies demonstrated that psoriasis psychosocially affects not only the~     patients, but also their close relatives. The psoriasis family index has been developed in~     an effort to objectively measure the health-related quality of life of the family members of~     patients with psoriasis. Nevertheless, data regarding the health-related quality of life of~     the parents of pediatric patients with psoriasis in the Turkish population are relatively~     scarce.~      In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood~     psoriasis on the quality of life of the patients' parents. Further, the investigators~     attempt to investigate the relation between the quality of life of the patients and their~     parents, and reveal disease characteristics which might influence the quality of life.~   "
19956|NCT02796001|"~     The primary objective of this study is to assess the relationship between rhinovirus~     specific T-cell immunity and the human host response to primary rhinovirus challenge and~     subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.~   "
19957|NCT02795988|"~     The Phase 1b study is an open-label, multicenter dose escalation study designed to assess~     the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The~     RP2D will be evaluated in the dose expansion Phase 2 study.~   "
19958|NCT02795975|"~     The objective of this study is to evaluate the performance characteristics of the AC2 assay~     on the Panther system using female urine specimens.~   "
19959|NCT02795962|"~     To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared~     to transfer to the closest Local Stroke Center, offers a better outcome in the distribution~     of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with~     clinically suspected Large Vessel Occlusion identified by Emergency Medical Services (EMS).~   "
19960|NCT02795949|"~     The continuous increase in the bacterial resistance rate and the slow arrival of new~     therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by~     stewardship programs to try to change this situation described worldwide is the use of~     antibiotics with the lowest possible antimicrobial spectrum.~      Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The~     empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several~     cases one or two antibiotics with antipseudomonal activity, being much less common than~     desirable a subsequent change to narrower spectrum antibiotics based on susceptibility data~     (de escalation). This is because the safety of de escalation is based only on expert~     advice and some observational studies, so their efficacy and safety is questioned by many~     clinicians and therefore its use is lower than desired. In fact, a recent systematic review~     of the Cochrane Library concluded that randomized studies to support this practice are~     needed. Investigators propose a real clinical practice-based randomized trial to compare~     the efficacy and safety of continuing with an antipseudomonal agents vs. de-escalation~     according to a pre-specified rule, in patients with bacteraemia due to Enterobacteriaceae.~   "
19961|NCT02795936|"~     This is a study to find out whether cardiac rehabilitation is a program that can work in~     Western Kenya.~      This study will test whether cardiac rehabilitation is feasible by measuring how many~     participants are able to follow and complete two different exercise protocols; one at home~     and one in hospital. It will also measure how the exercise intervention affects quality of~     living, depression and improvement in exercise tolerance.~   "
19971|NCT02795793|"~     This study is designed to determine the safety and efficacy of non-operative antibiotic~     management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled~     patients will be randomised and an allocation ratio of 1:1 will be made via weighted~     minimisation, where half of the patients will receive non-operative management with~     intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.~   "
19972|NCT02795780|"~     This study will evaluate longitudinal change of tau deposition as measured by 18F-AV-1451~     uptake over time.~   "
19962|NCT02795910|"~     This study will evaluate a complex intervention based on a patient management tool (PMT),~     combined with educational outreach to primary care doctors, nurses and other health workers,~     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality~     of primary health care and health outcomes, in adults with diabetes and cardiovascular~     disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating~     48 primary care clinics to receive the intervention or not, and comparing patient and clinic~     level endpoints that reflect the health and quality of care provided over the following~     year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000~     with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart~     failure or cerebrovascular disease) in participating clinics will be included in the study.~     About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1.~     Number of participants in whom at least one of the following tests was recorded: body mass~     index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a~     diagnosis of hypertension recorded previously, average systolic blood pressure recorded.~     Secondary endpoints will include the individual components of the composite scores, health~     measures (hospital admissions and deaths), and indicators of appropriate diagnosis of~     comorbid conditions such as depression. Eligible patients will be identified and outcomes~     measured using electronic medical records.~   "
19963|NCT02795897|"~     The purpose of this study is to look for abnormal genes and gene expression profiles that~     help determine why a person develops amyotrophic lateral sclerosis (ALS) and related motor~     neuron diseases (MND) and why their symptoms present and progress with a particular pattern.~   "
19964|NCT02795884|"~     This study will be performed as a local multicenter, randomized, phase III clinical study.~     It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation~     (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation~     adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to~     the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the~     ratio of 1:1. The treatment regimen of each arm is as follows.~   "
19965|NCT02795871|"~     The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause~     of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for~     virilization of the external genitalia in girls through androgen hypersecretion during fetal~     life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone~     (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen~     hypersecretion in affected girls and avoiding poor long-term results from reconstructive~     surgery. Prenatal DEX was used in Europe and the USA but its use was recently suspended: in~     2007, a Swedish study conducted on 26 children treated with DEX in utero for a short period~     of time reported cognitive impairments. These data were not confirmed by an American study~     on the short-term DEX use, which showed potential cognitive impairments in CAH children~     exposed to DEX for long periods of time. These confusing and controversial results have~     caused the scientific community to question its position and have resulted in the suspension~     of the use of prenatal DEX with drastic consequences for CAH girls (virilization; genital~     surgery etc.). In this context, an evaluation of neuropsychological development under in~     utero DEX is essential to validate its indication for use during the prenatal period. This~     study will evaluate outcomes using prospective cognitive and emotional assessments. It will~     first focus on the unaffected children previously treated in utero in order to assess the~     adverse effects of the drug. The study will then assess the children with CAH for whom DEX~     could have beneficial effects.~   "
19966|NCT02795858|"~     This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced,~     Progressive Carcinoid Tumors.~   "
19967|NCT02795845|"~     During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal~     candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment~     options are limited. Lactobacilli administration was suggested to treat and prevent vaginal~     infections. However, this has not been examined in pregnant women, the information regarding~     oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce~     vaginal lactobacilli proliferation are not well established. In the present study we will~     examine if oral probiotics are effective in prevention and eradication of vaginal infections~     by migration of lactobacilli from the digestive system to the vagina in pregnant women.~   "
19968|NCT02795832|"~     A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential~     Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice~     Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2~     Weeks in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis~   "
19969|NCT02795819|"~     This phase 1 study will identify recommended phase 2 doses (RP2Ds) of AR-42 and pazopanib~     when given in combination for subsequent clinical trials and may potentially identify~     candidate pharmacodynamic and predictive biomarkers.~   "
19970|NCT02795806|"~     Background: Electronic health records contain a vast amount of data about diseases and~     treatments. Researchers could use this data to test their ideas, but they would need to use~     records from more than just their own group of patients. But access to those records is~     restricted to ensure patient privacy.~      U.S. National Library of Medicine (NLM) has created a computer tool called NLM Scrubber.~     This program recognizes and deletes personal information from health records. The~     researchers who developed this program now need access to the original records. This will~     allow them to see how well the program removes personal information from patient records and~     how they can make it more accurate.~      Objectives:~      To find ways to improve clinical text de-identification.~      Eligibility:~      No new participants. Researchers will review data that have already been collected.~      Design:~      Researchers will collect a random sample of reports. These will be from different doctors in~     different fields.~      Researchers will manually remove personal information from the records.~      Researchers will also automatically remove personal information from original records using~     NLM-Scrubber.~      Researchers will compare the results of the computer program versus the manual changes. They~     will note when the program has not been removing personal information correctly. They will~     also note when the program has been deleting nonpersonal health information incorrectly.~      Researchers will use the results to revise the program. They will keep testing it until the~     de-identification process is complete.~   "
19973|NCT02795767|"~     This single-arm study will enroll children (less than [<] 12 years of age) and adolescents~     (12 to 17 years of age) with hemophilia A and FVIII inhibitors who are currently receiving~     treatment with bypassing agents. Participants will receive weekly subcutaneous (SC) doses of~     emicizumab for a designated period of 52 weeks. All participants will continue to receive~     standard of care/background treatment with their usual episodic bypassing agent therapy to~     treat breakthrough bleeds as needed.~   "
19974|NCT02795754|"~     GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for~     the treatment of HIV in combination with other antiretroviral therapy (ART). The primary~     objectives of this study are to investigate the safety, tolerability, and pharmacokinetics~     (PK) of single and repeat doses of GSK2838232. This study will be a double-blind,~     placebo-controlled, single and repeat dose escalation study. This study will be conducted in~     two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD)~     doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of~     GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams~     (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative~     bioavailability of single doses of crystalline active pharmaceutical ingredient (API)~     Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In~     Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days~     as sequential dose cohorts. Maximum duration of study participation will be approximately 10~     weeks.~   "
19975|NCT02795741|"~     The Cooling Bolero is a a vest filled with a new material (not ice or a gel) that provides~     controlled cooling by absorbing heat. The vest is manufactured by Nanohealth. It intended to~     provide moderate cooling (~15C/59F) through indirect contact with the skin. The material in~     the device is safe, non-toxic, and eco-friendly.~      Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot~     flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep~     disturbances) have shown a reduction in both the frequency and intensity of those symptoms~     after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and~     upper torso appears to target and mitigate these common menopausal symptoms. This pilot~     study attempts to collect additional data on the effects of the Cooling Bolero.~   "
19976|NCT02795728|"~     Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure~     sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design~     ,a double blind randomized controlled clinical trial was conducted to compare the retention~     and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass~     ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years~     age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either~     side of the first mandibular permanent molars. They were recalled for assessment of sealant~     retention at intervals of 3, 6 and 12 months.~   "
19977|NCT02795715|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
19978|NCT02795702|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
19979|NCT02795676|"~     This is a randomized, double blind, active control study of PRX-102 in Fabry disease~     patients with impaired renal function. Patients treated for at least 1 year with agalsidase~     beta and on a stable dose for at least 6 months will be screened and then randomized to~     continue treatment with either agalsidase beta at the same dose or to treatment with 1 mg/kg~     of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator.~     Patients will receive intravenous infusions every two weeks. Patients will be randomized in~     a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary~     protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample.~   "
19980|NCT02795663|"~     -  Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective~          treatment for a large variety of movement disorders. However, the efficacy of STN-DBS~          relies on unclear mechanisms.~        -  Purpose: In this study, using optical imaging, the investigators will evaluate the~          cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor~          task and delay discounting task. the investigators will perform an optical imaging~          study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS.~          The investigators will measure bilateral local cortical hemodynamic changes under On~          and Off stimulation conditions and during a motor task (left hand movement) and delay~          discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will~          be continuously analyze.~        -  Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and~          total Hb) under  on  and  off  stimulation during a motor task.~   "
19981|NCT02795650|"~     This is a multicenter, open label, randomised phase II clinical trial for patients with~     metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will~     undergone tumoral biopsy before starting first line of treatment and will be administered~     personalised therapy as second or third line.~   "
19982|NCT02795637|"~     Study of the what the body does to the drug in subjects with mild, moderate, and sever liver~     dysfunction (not working properly)~   "
19983|NCT02795624|"~     Specific Aim 1. Characterize the long-term effects of secondhand smoke (SHS) on vascular~     health in pre-ban flight attendants (FAs). Investigators will measure arterial stiffness~     (pulse wave velocity and augmentation index) and endothelial dysfunction (reactive hyperemia~     index) in the pre-ban FA cases, and compare to the cardiovascular risk-factor matched~     Framingham controls.~      It is hypothesized that pre-ban FA cases have increased arterial stiffness (higher pulse~     wave velocity and higher augmentation index) and increased endothelial dysfunction (lower~     reactive hyperemia index) compared to Framingham controls.~      Specific Aim 2. Determine the extent in which remote pre-ban SHS exposure (hours) is~     associated with increased arterial stiffness or endothelial dysfunction.~      Investigators hypothesize that pre-ban SHS exposure is positively associated with both~     increased arterial stiffness and increased endothelial dysfunction.~      Specific Aim 3. Investigators will calculate the cardiovascular risk scores (Framingham,~     Reynolds, and ASCVD) by using subjects' age, blood pressure, family history, lipid panel,~     and highly sensitive C-reactive protein. Investigators will explore the association of the~     risk scores with measures of vascular aging (arterial stiffness and endothelial~     dysfunction). These scores do not include SHS exposure. Investigators will also test the~     additive value of SHS exposure in increasing arterial stiffness and endothelial dysfunction~     using the risk scores as an adjustment value.~      It is hypothesized that the cardiovascular risk scores are associated with vascular aging~     (arterial stiffness and endothelial dysfunction), and that the association between SHS~     exposure and vascular aging remains significant after adjusting for the cardiovascular risk~     scores.~      The significance of this proposal and impact will be (1) mechanistic insights into how~     remote SHS exposure leads to hypertension and vascular stiffness, (2) increased~     understanding of how SHS exposure can increase risk of cardiovascular disease, which is the~     number one cause of death in the United States.~   "
19984|NCT02795611|"~     Play skills and participation of children with Autism Spectrum Disorder (ASD) have been~     restricted by their core symptoms, resulting in heightened parenting stress and affected~     family daily life. This research aims to improve play skills and participation of children~     with ASD through 'family-centered occupational therapy', thereby leading to positive outcome~     for not only the child but also the whole family.~   "
19985|NCT02795598|"~     The investigators plan to determine the incidence of hemi-diaphragmatic paresis (HDP) with~     two commonly used techniques of supraclavicular nerve block, the single and double injection~     techniques.~      It is our hypothesis that a double injection peripheral nerve block technique will increase~     the risk of HDP when compared to a single injection technique.~   "
19986|NCT02795585|"~     Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of~     coronary stenosis by calculation of the pressure in the vessel based on two angiographic~     projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed~     during coronary angiography and compare diagnostic accuracy to standard FFR.~   "
19987|NCT02795572|"~     The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg~     oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three~     times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer~     Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or~     reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).~   "
19988|NCT02795559|"~     It has been suggested that obesity occurs because the colonic microbes in obese individuals,~     compared to those who are lean, produce more short chain fatty acids during the fermentation~     of dietary fiber; this means that obese individuals obtain more energy from dietary fiber~     than lean. On the other hand, it is possible that the ability of colonic short chain fatty~     acids to improve glycemic control and suppress appetite may be reduced in obese subjects.~     The aim of this study was to determine the acute effects of 2 fibers commonly used as food~     ingredients, inulin and resistant starch, on postprandial serum responses of short chain~     fatty acids, glucose, insulin, free-fatty acids and selected gut hormones in lean and~     overweight or obese subjects.~   "
19989|NCT02795546|"~     The aim of the present study was to evaluate the bone formation potential of 400µg~     alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.~   "
19990|NCT02795533|"~     The current study is a continuation of the study Effect of early rehabilitation in patients~     with acute aSAH which was approved by the Regional Committee for Medical Research Ethics,~     South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586 (Clinical~     Trials gov. identifier NCT01656317). The original study was a prospective, controlled,~     interventional study comprising patients managed at the neuro-intermediate ward following~     repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed~     consent form and were included in the study. Patients were assessed in the acute phase, as~     well as a 3 and 12 months post ictus. The main research goal of the present study will be to~     assess physical, cognitive and emotional function 5 and 10 years after aSAH in the 2011-2012~     population. In addition we will also describe quality of life and work-status along with the~     time-course of recovery from the acute sage after aSAH to the chronic phase.~   "
19991|NCT02795520|"~     The purpose of Phase I of this study is to test the safety and tolerability of the~     investigational drug, OTS167, and that of Phase II of this study is to confirm the potential~     response benefit of OTS167.~      OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated~     antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. In~     this study OTS167 will be administrated to patients with AML, ALL, advanced MDSs, advanced~     MPNs, or advanced CML.~   "
19992|NCT02795507|"~     The purpose of this study is to investigate the effects of training of the non-involved~     upper limb on the motor ability of the hemiparetic upper limb in patients with unilateral~     sensorimotor motor impairments. The secondary aims are to investigate the relation between~     lesion characteristics and responsiveness to the treatment, and to study which brain~     structures are activated during a task trained in the treatment.~   "
19993|NCT02795494|"~     Patient oriented clinical outcomes have increased in use and popularity and provide a~     comprehensive assessment of the level of symptoms and function experienced by a patient.~     Though several measures have been developed and shown to be valid, reliable, and responsive~     in adults, such efforts have only been rarely undertaken in pediatric populations.~     Specifically, there has been no validation of the predominant adult hip specific outcome~     measures, such as the WOMAC and Oxford-12, in children and adolescents. Prior to using such~     measures in pediatric patients, it is necessary to establish the psychometric properties of~     these measurements in this population.~      The objective of this study is to determine the reliability and validity of the WOMAC hip~     scores in a pediatric population, between five and nineteen years of age, with Perthes~     disease. The results of this study will accomplish the above goal, thereby allowing either~     for widespread use of these measures in pediatric hip disorders or emphasizing the necessity~     for development of a pediatric hip specific outcome measure.~   "
19994|NCT02795481|"~     Stroke is one of the leading causes of death and disability in the UK and currently costs~     the country £7bn per year. There is an overwhelming need to accurately and rapidly triage~     patients to allow best use of finite NHS specialist resources for the treatment of stroke.~      A simple blood test of substances (the purines) that result from cellular metabolism and are~     produced in excess when brain cells are starved of oxygen and glucose (as occurs during a~     stroke) is proposed. The sensors designed by the investigators are used to measure blood~     purines during a procedure in which blood flow to the brain is reduced to allow surgical~     interventions on the major arteries that supply the brain. Previous studies by the~     investigators have shown that as soon as blood flow to the brain is reduced, purines are~     produced within minutes and are detectable in systemic arterial blood.~      The current project will now compare the levels of purines in the blood of stroke patients~     and controls. The purines will be measured on admission to hospital and 24 hours later. The~     occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and~     72hrs after admission. This study will establish whether purines are elevated in the blood~     of stroke patients on admission to hospital compared to healthy controls, and whether this~     correlates with the size of the stroke and damage to the brain.~   "
19995|NCT02795468|"~     The investigators are trying to compare the ultrasound-guided technique vs. palpation method~     for radial arterial cannulation in infants.~   "
19996|NCT02795455|"~     The researchers plan to explore brain networks involved in emotion processing and learning~     using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a~     small number of high-calorie or high-fat foods. By studying why individuals with AN are~     disgusted by food or other eating situations, the researchers will be able to understand~     more about the neurobiological pathways that lead to restricting food intake and food~     avoidance. This study also aims to find whether one of two short-term interventions~     (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain~     and if the treatments affect food avoidance. IE is an intervention that helps reduce anxiety~     about eating. FBT is an intervention that motivates patients to eat through working with~     family to increase the value of eating and decrease the value of avoiding foods.~   "
19997|NCT02795442|"~     The purpose of this study is to determine if when one eats protein can change how the body~     uses food for energy. Researchers will also test if eating a high protein breakfast can~     change one's craving for snack foods.~   "
19998|NCT02795429|"~     The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered~     i.v. as a single agent or in combination with INC280 administered orally in adult patients~     with advanced hepatocellular carcinoma (HCC).~   "
19999|NCT02795416|"~     Secukinumab targets a different interleukin and has potential to be used as alternative to~     existing treatments. This study will provide clinical data with respect to efficacy through~     Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and~     evaluate the impact of the treatment on quality of life and work productivity in subjects~     with moderate to severe plaque psoriasis in the Turkish population.~   "
20000|NCT02795403|"~     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough~     understanding of the biology of one of its major causative agents, the hepatitis C virus~     (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is~     mounting evidence on several viral species that virion-bound proteins are prone to be~     involved either at the replication, budding/egress or entry/release steps of the viral~     cycle.~      Identifying such targets may yield ideal candidates for gaining insight on the dependence of~     HCV upon a restricted subset of host proteins, therefore providing refined sets of~     genetically stable targets for therapy. This project's goals are to set up adequate~     conditions for robust and reproducible purification of HCV virions in clinical samples,~     followed by the identification of their HCV-bound host proteins and the characterization of~     their functions. Proteomics profiling of HCV particles purified from clinical samples will~     be overlaid with proteins identified and characterized in cell culture grown HCV particles~     during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets~     identified in both samples sets will be subjected to in vitro investigations using~     HCV-replicating cells. Conventional biochemical and imaging methods will be used in order~     to: (i) ascertain their physical association with HCV virions; (ii) define the modalities of~     their interaction with HCV proteins; (iii) decipher the topology and subcellular~     localization of their association with HCV proteins and virions; (iv) quantitatively assess~     their functional involvement in particle budding, egress or secretion and infectivity. A~     candidate that yielded satisfactory results in these experiments will be disclosed and~     further investigated at the level of structural biology, in collaborative research programs.~   "
20001|NCT02795390|"~     It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients~     who do not response to current laxatives treatment. 60 patients will be randomly assigned to~     have individualized herbal intervention (treatment group) or placebo (control group) in 1:1~     ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core~     prescription. Furthermore, two out of six herbal granules can be added according to the~     syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%),~     tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste,~     and texture comparable to the herbal granules. Patients are instructed to dissolve the~     granules in 150ml of hot water, twice daily for two weeks. The primary end point is the~     global symptom improvement. Secondary outcome measures include stool frequency, stool form,~     use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most~     severe) and individual assessment of constipation related symptoms. For the safety profiles~     of herbal intervention, the important adverse events reported and clinical laboratory~     evaluations of liver and renal function are determined.~   "
20002|NCT02795377|"~     Membrane microparticles are submicron fragments of membrane vesicles shed from various cell~     types. Circulating endothelial microparticles have been proposed as markers of endothelial~     injury. However, which mechanical forces contribute to their release is not clear.~   "
20003|NCT02795364|"~     Gliomas,especially high-grade glioma ,are the most common primary malignant brain tumor in~     adults,yet outcomes from this aggressive neoplasm remain dismal.The extent of resection is~     one of the most essential factors that influence the outcomes of glioma resection.However,~     conventional structural imaging has failed to accurately delineate glioma margins because of~     tumor cell infiltration. the investigators have finished few project that suggest the~     feasibility of Magnetic Resonance Spectrum(MRS)-guided resection,unfortunately, lacking~     sufficient clinical evidence.This prospective cohort study is to provide a clinical evidence~     for the validity of MRS-guided resection in patients with HGG .~   "
20004|NCT02795351|"~     In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and~     migraine headache induction is tested in patient with migraine with aura.~   "
20005|NCT02795338|"~     It is unknown whether imaging technologies have broad applications in brain mapping due to~     limited knowledge of the value of the results. Accurate identification of areas of eloquent~     brain function is vital to surgical decision making and to preservation of independence as~     patients with brain tumors who are higher functioning have better survival outcomes. Imaging~     technology has evolved to provide multiple non-invasive modalities for pre-operative testing~     of eloquent brain function and include functional MRI (fMRI) and magnetoencephalography~     (MEG). Eloquent brain is defined as a region controlling language, motor, or sensory~     function such that without its proper input, a person would be left with significant~     neurologic deficits.~      Studies conducted by our group and others have shown that these non-invasive mapping~     modalities provide useful information, however, the information provided inconsistently~     predicts distribution of eloquent function.~      Direct electrical stimulation (DES) at the time of surgery allows assessment of eloquent~     function directly from the brain surface (invasive) and is considered the gold standard in~     brain mapping. Therefore, in order to determine the true clinical applicability of the~     non-invasive mapping technologies, we propose to: (1) assess the predictive value of fMRI~     and MEG for sensorimotor and language functions by comparing their results to DES and (2)~     determine whether fMRI or MEG provides the most consistent and accurate information. We will~     accomplish these Aims by co-registering all mapping data (invasive and non-invasive) in a~     modifiable 3D rendering. In this way, we can evaluate the DES to fMRI and MEG as well as~     compare fMRI to MEG. The rationale for the proposed research is that understanding the~     reliability of our current technology will allow us to perform safer surgeries and to~     preserve neurologic function. The expected outcomes for the work proposed in Aims 1 and 2~     are identification of a predictive value for fMRI and MEG and determination if one modality~     should be utilized over the other pre-operatively for the most accurate information. The~     results of this study are expected to have an important positive impact because~     identification of accurate pre-operative non-invasive mapping modalities will allow tailored~     testing and possibly lead to negation of the need for intra-operative mapping in certain~     cases. It will also enhance patient outcomes by improving patient safety. Furthermore, it~     will serve as the basis for a multi-institutional mapping data bank.~   "
20009|NCT02795286|"~     The ASIST study is a medical device study testing the safety and efficacy of a new~     hemodialysis machine software in chronic haemodialysis patients. The software's intention is~     to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by~     adapting the dialysis fluid ion concentration to the patients plasma ion concentration by~     conductivity measurement.~   "
20010|NCT02795273|"~     The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and~     to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication~     during the grass pollen season~   "
20011|NCT02795260|"~     The investigators recruit about 1800 cases participants who has signed ICF,then do some~     physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific~     gamma-interferon detection ,collection of medical history and the like .These subjects who~     meet the standard are considered as study population I. Population I are injected~     intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at~     different arm of the same subject and get at least 360 participants whose three kinds of~     detection result are all negative and are considered as study population II.Then,they are~     immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG.Do specific~     gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10~     and TB-PPD at different arm of the same subject 12 weeks after immunity.~   "
20012|NCT02795247|"~     The purpose of this study is to compare the tomographic results of patients who underwent~     single-bundle anterior cruciate ligament reconstruction at the investigator's institution~     using the transtibial, accessory medial portal technique and the modified transtibial~     technique to determine which technique best recreates the anterior cruciate ligament~     anatomic footprint.~   "
20013|NCT02795234|"~     The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups~     of patients and healthy volunteer. A second goal is to find the relation between Vitamin D~     Antibody and Vitamin D level.~   "
20014|NCT02795221|"~     Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's~     characterized by activation of immune system, microvascular changes and intimal~     proliferation.~      The EULAR/ACR 2013 criteria for the classification of SSc will help identify SSC patients~     before fibrosis of internal organs and will allow early treatment.~      Patient with RP, SSc-related autoAb, anti-topoisomerase I (SCL-70), anti-centromere autoAb,~     anti-RNApolymerase III, abnormal nailfold capillaries and puffy hands would have SSc.~      The OR of abnormal capillaroscopy for subsequent development of SSc can reach 163 with~     positive predictive value of 52% and negative predictive value of 99% .Some studies found~     that preclinical internal organ involvement in pre-scleroderma patients, DLCO<80% was~     detected in 11/32 patients with RP plus SSc-associated autoAb plus SSc-type nailfold~     capillary changes.~      The heritability of SSc was considered controversial in the, largest published SSc .Twin~     study, which in general suggested a modest genetic contribution to the Phenotype~     .Nevertheless, this study included only 42 sets of twins, and it should Be considered that,~     in a family study of 703 cases, an affected first-degree relative Increased the risk of SSc~     13 times compared to the general population . Moreover, having an affected sibling increased~     SSc risk by 15 times , and there Was a remarkable concordance of auto antibodies between SSc~     twins . Additionally, recent analyses have shown that the standardized incidence ratio of~     SSc seemed to be less than those observed in autoimmune diseases (ADs) such as Rheumatoid~     arthritis or Ankylosing Spondylitis, but similar to those observed for Hashimoto,~     thyroiditis or psoriasis. In addition, SSc prevalence, clinical Outcomes and autoantibody~     profiles have been reported to vary depending on Patient ancestry Therefore, the role of~     genetic factors in SSc susceptibility can now be considered solidly established.~      A positive family history of SSc appears to confer a risk that is at least 10-16-fold Higher~     than normal for SSc in first-degree relatives and 10-27-fold higher than Normal for SSc in~     siblings, and thus represents the strongest susceptibility factor Yet reported for this~     disease .~   "
20015|NCT02795208|"~     This study test whether a lung recruitment maneuver improves the right ventricle performance~     after cardiopulmonary bypass. Half of the patients received an standard protective~     ventilation and the other half the same ventilatory pattern after a lung recruitment~     maneuver.~   "
20016|NCT02795195|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) with the fraction size of 3 GyE in the treatment of~     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment~     at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate~     the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and~     within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is~     determined, the MTD will be used as the recommended dose to patients fulfilling the~     inclusion criteria in the Phase II part of the trial.~   "
20017|NCT02795182|"~     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with~     BGB-A317 in subjects with B-cell lymphoid malignancies.~   "
20018|NCT02795156|"~     With the increased availability of next-generation sequencing, oncologists are starting to~     incorporate genomic profiling into routine care of cancer patients. If a genomic alteration~     is identified during profiling, it could help guide the choice of therapy and improve~     treatment outcomes. This study will examine the anti-tumor activity of two FDA-approved~     therapies to treat patients who were previously profiled with next-generation sequencing~     technology and who failed first-line treatment for one of the following tumor types:~     non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and~     upper aerodigestive tract cancer.~   "
20019|NCT02795143|"~     The purpose of this study is to determine whether isotretinoin is helpful in treating~     patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).~   "
20020|NCT02795130|"~     Small-incision vitrectomy techniques have become increasingly popular, with a number of~     advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23-~     and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain~     fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require~     suture placement. Poor wound closure puts the patient at increased risk of post-operative~     hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are~     divided as to which suture is the best for sclerotomy closure. The current standard of care~     is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to~     work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain~     gut suture, which is more difficult to manipulate and thicker, but causes less tissue~     inflammation1. The purpose of this study is to prospectively evaluate these two options for~     sclerotomy closure. The results of this study will enable us to minimize patients'~     post-operative discomfort while maximizing safety outcomes.~   "
20021|NCT02795117|"~     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an~     FDA approved product for the treatment of inflammatory lesions rosacea~   "
20022|NCT02795104|"~     This randomized clinical trial studies how well a tailored interactive digital versatile~     disc (DVD) with or without patient navigation works in improving screening rates in rural~     women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD~     and patient navigation may help rural women to learn more about cancer screening and to~     better understand the results.~   "
20023|NCT02795091|"~     Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated~     with age, organ dysfunction, invasive treatment and enviroment cleaning. According to~     hospital hygienic standard for disinfection, total numbers of colony of air and the object~     surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different~     methods will be used to evaluate the disinfection effects in ICU enviroments.~   "
20024|NCT02795078|"~     Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the~     common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed~     to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial~     arterial stenosis.~   "
20025|NCT02795065|"~     The purpose of this study is to compare two types of low-molecular-weight heparin,~     enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism~     prevention among intensive care unit patients.~   "
20026|NCT02795052|"~     This is a human clinical study involving the isolation of autologous bone marrow derived~     stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages~     in order to determine if such a treatment will provide improvement in neurologic function~     for patients with certain neurologic conditions.~   "
20027|NCT02795039|"~     The purpose of this study is to demonstrate bioequivalence between the test drug product,~     fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50~     mg/mL.~   "
20028|NCT02795026|"~     Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor~     dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other~     pathology exists. The effectiveness of manual therapy in studies have shown statistically~     significant pre and post treatment differences.However no study has reviewed the efficacy of~     inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD.~     This study will investigate the effectiveness of trans-perineal trigger point dry needling~     used with manual therapy techniques for CPP.~   "
20029|NCT02795013|"~     Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL~     in more than one child, or parent and child). Because affected individuals in familial HL~     are genetically related, the existence of such families has long been considered as evidence~     in support of a genetic basis of HL susceptibility. However, it is largely unknown which~     genetic variations are responsible for recurring HL in families. Because the effects of~     genetic variants are likely to be strong in familial HL, identification of such variations~     will potentially reveal biological pathways critical to the pathogenesis of HL.~      PRIMARY OBJECTIVE:~        -  To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases~          (affected as well as non-affected family members) to identify potential disease-causing~          germline genetic variations.~      SECONDARY OBJECTIVE:~        -  To describe demographic and clinical features of the affected families.~   "
20030|NCT02795000|"~     The purpose of this research is to develop a predictive nomogram for primary ovarian~     insufficiency.~   "
20031|NCT02794987|"~     Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic~     procedure, however it has an important image limitation. The fluoroscopic cholangiography~     shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is~     seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of~     missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough,~     Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization~     of the pancreatico-biliary system and the evaluation of intraductal lesions. It has a~     digital sensor with 4x resolution and a 1.2 mm working channel that allows the passage of~     the SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and~     SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of~     76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using~     blind biopsy brushing catheter respectively. Although it has been described before~     cholangioscopic images of malignant biliary lesions like an irregular lesion surface with~     irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there~     is no current validated classification that allows unify the diagnostic criteria.~      Methods: Study design: The study was design to be performed in 2 stages. Stage 1:~     observational, retrospective study with case collection from September 2013 to September~     2015. Patients included had bile duct tissular lesion detected by POCS. The images were~     correlated to histopathology and 6 month follows up and a classification was finally~     performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with~     bile duct tissular lesion detected by POCS, will be the evaluated in a prospective,~     non-randomized and double blind manner. Two groups of endoscopist will evaluate the images~     but only one group will do it using the classification previously performed. Second stage~     case collection has already started (December 2015) and will include patients until December~     2016.~        -  Endpoint Classification: Efficacy~        -  Intervention Model: Non interventional~        -  Primary Purpose: Diagnosis~   "
20032|NCT02794974|"~     The investigators test with the present study design, whether an ultrasound-guided blockade~     of the cervical plexus in combination with an additional application of local anesthetic to~     the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality~     of anesthesia.~   "
20033|NCT02794961|"~     CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present~     study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.~   "
20034|NCT02794948|"~     The purpose of this research is providing valuable traditional chinese medicine theory and~     formula in treating Primary Ovarian insufficiency.~   "
20035|NCT02794935|"~     This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea~     hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive~     function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in~     patients with heart failure and obstructive sleep apnea syndrome.~   "
20036|NCT02794922|"~     The purpose of this study is to determine effectiveness of vitamin B in reducing~     temporomandibular joint disorder (TMD) pain. Patients will be randomised to receive the~     study drug or placebo. The study drug we are using is a combination of vitamin B1(thiamine~     mononitrate)-242.5mg; vitamin B6(pyridoxineHCl)-250mg, and vitamin B12(cyanocobalamin)-1mg.~     We will assess patient's pain level, range of jaw movement and record any side effects from~     using this medication.~   "
20225|NCT02792465|"~     This is a phase 1 study of investigational agent CFI-402257 in patients with advanced~     cancer. The purpose of this study is to see how safe and tolerable CFI-402257 is in cancer~     patients as well as the pharmacokinetics (PK). This study is the first time that CFI-402257~     is given to humans.~   "
20037|NCT02794909|"~     The proposed study is a prospective cohort study in which a select group of emergency~     physicians at Komfo Anokye Teaching Hospital (KATH) in Ghana will be trained in~     cardiopulmonary ultrasound (CPUS). Following the training, patients who present to the ED~     with undifferentiated shock and/or dyspnea will either receive usual and customary care~     supplemented with cardiopulmonary ultrasonography-guided diagnosis and treatment during~     their initial resuscitation, or usual and customary care alone depending on whether the~     treating physician has received CPUS training. The main outcomes is the impact of CPUS on~     correct diagnosis. Information regarding initial treatment strategies, diagnoses and 24-hour~     mortality will be collected via manual review of paper charts and medical records.~   "
20038|NCT02794896|"~     Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells~     effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects~     undergoing extended shoulder surgery under continuous regional anesthesia randomly were~     assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour.~     Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte~     phagocytosis activity.~   "
20039|NCT02794883|"~     The main purpose of this trial is to investigate the effects of a new class of drugs that~     help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These~     drugs have already shown benefit in some other cancer types and are now being explored in~     GBM. Both tremelimumab and durvalumab (MEDI4736) are investigational drugs, which means~     that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are~     antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab~     attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping~     certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates~     (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called~     CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment~     options for patients with glioblastoma.~   "
20040|NCT02794870|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to CIR 311.~   "
20041|NCT02794857|"~     This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence~     of systemic inflammation. Half of participants will receive NP001 and the other half will~     receive placebo.~   "
20042|NCT02794844|"~     USING GENETIC INFORMATION ABOUT THE INDIVIDUAL TO PICK THE RIGHT DRUG FOR THE RIGHT DISEASE~     AT THE RIGHT DOSE DEFINES PERSONALIZED MEDICINE. THIS PILOT STUDY SEEKS TO INSTITUTE~     PHARMACOGENOMIC TESTING, THAT IS IDENTIFYING GENETIC VARIATION THAT INFLUENCES PATIENT~     RESPONSE TO DRUGS, INTO THE NEMOURS CHILDREN'S HEALTH SYSTEM. WE PROPOSE TO INITIATE THE~     STUDY BY IDENTIFYING GENETIC DIFFERENCES IN CYP2C19, A GENE THAT IS RESPONSIBLE FOR A~     CERTAIN ENZYME IN THE LIVER THAT METABOLIZES MANY DRUGS INCLUDING A CLASS OF DRUGS CALLED~     PROTON PUMP INHIBITORS (PPI; PREVACID, NEXIUM). PPI ARE USED TO TREAT HEARTBURN AND OTHER~     SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) AND ARE EXTENSIVELY USED IN PEDIATRICS.~     CHRONIC USE OF PPI CAN CAUSE SERIOUS SIDE EFFECTS INCLUDING COLD, PNEUMONIA AND STOMACH~     INFECTIONS, WHICH GETS WORSE AT HIGHER DOSES. CHILDREN WHO POORLY METABOLIZE DRUGS BECAUSE~     OF GENETIC VARIATION IN CYP2C19 SHOULD GET LOWER DOSES OF PPI THAN CHILDREN WHO METABOLIZE~     PPI NORMALLY. OUR PILOT STUDY WILL GENOTYPE CHILDREN WITH GERD OR OTHER STOMACH ACID~     MEDIATED CONDITIONS FOR WHICH A PPI IS PRESCRIBED USING A SAMPLE OF SPIT TO DETERMINE WHICH~     DOSE OF PPI THEY GET BASED ON THE FORM OF THE CYP2C19 GENE THEY HAVE. WE WILL STUDY 120~     CHILDREN 2-17 YO DIAGNOSED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) OR OTHER STOMACH ACID~     MEDIATED CONDITIONS FOR WHICH A PPI IS PRESCRIBED . GENETIC RESULTS ARE AVAILABLE IN < 60~     MINUTES, AND THEIR DOSES ARE DETERMINED BY THEIR DOCTOR BASED ON GENETIC RESULTS. THIS STUDY~     WILL ALLOW US TO GAIN VALUABLE EXPERIENCE THAT WILL BE USED TO EXPAND OUR GENETIC PROGRAM TO~     OTHER GENES AND DRUGS.~   "
20043|NCT02794831|"~     -  NSAIDs are widely consumed, and some are currently available for self-medication with~          indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014)~        -  There is no recommendation to limit their use in bacterial infections except for~          chicken pox in children.~        -  To date, no study has highlighted the aggravating role of exposure to NSAIDs on~          bacterial infections in adults, based on the usual septic severity Levy's score (SSS),~          and mortality, but it delays adequate antibiotics (Legras, Critical Care, 2009)~        -  Community-acquired bacterial infections in adults exposed to NSAIDs are serious by~          their spread (multiple locations), and suppurative character requiring frequent use of~          invasive procedures such as surgery or drainage. The SSS does not reflect the~          seriousness of these infections. They are frequently associated with use of ibuprofen~          (63.4%), and self-medication practices (65.5%).~      The main hypothesis is that NSAIDs exposure is associated with a specific severity of~     community-acquired bacterial infection, marked by dissemination, suppurative complications~     or even invasive procedures requirement.~      Our objectives are also to:~        -  Describe what NSAID use terms are associated to the risk of serious bacterial~          infections: molecule, dosage, duration of exposure, access (prescription or~          self-medication), associated drugs.~        -  To determine what type (s) (s) of bacterial infection is worsened by exposure to~          NSAIDs.~        -  To determine if other risk factors contribute to severity of bacterial community~          acquired infection~        -  To describe hospital costs associated to such severity of bacterial infection~   "
20044|NCT02794818|"~     To provide prescriptions for weekly Community Supported Agriculture (CSA) boxes of fruits~     and vegetables to patients, accompanied by nutritional education (e.g. printed newsletters~     and YouTube videos), and evaluate benefits for participants by exploring commitment to the~     program, opinions about healthy eating, retention of nutrition and food preparation~     knowledge, overall takeaway from the program, as well as self-assessment of health status.~      To establish the overall feasibility of an effective prescription produce program for~     at-risk and underserved patients - called ProduceRx - by utilizing produce from regional~     farms in addition to the resources of the Penn State Health System and an interdisciplinary~     team of healthcare workers (dietitians, dietetic interns, and medical students).~      To provide a proof-of-concept for this model (i.e. ProduceRx + interdisciplinary approach to~     health education) for other healthcare institutions.~   "
20045|NCT02794805|"~     An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in~     subjects with risk. The gold standard will be MRI.~   "
20047|NCT02794779|"~     Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in~     Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum~     hemorrage because uterine atony is the most prevalent cause. Both excessive and too low~     oxytocin doses threaten the life of women.~      Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.~      Method: adaptative clinical trial using a modified up and down method of two sequential~     groups: rule of three and continuous infusion. Allocation in rule of three or continuous~     infusion will be random and masked for patients and anesthesiologists. The minimum effective~     dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).~   "
20048|NCT02794766|"~     Halitosis associated with tongue coating results from the production of volatile sulfur~     compounds by bacterial action. The use of prebiotics and probiotics might be useful in~     treating such condition. The aim of this study was to evaluate the effect of the prebiotic~     inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.~   "
20049|NCT02794753|"~     The principal aim of this study is to establish the impact of Cognitive Training in patients~     with primary Hair-pulling Disorder. Half of the participants will be training with the true~     training intervention and the other half with the active control intervention.~      Study findings will also provide information on whether an internet based CT intervention,~     done at patients' homes, is feasible as a mode of treatment for HPD patients in SA.~   "
20050|NCT02794740|"~     Primary Objectives:~      To evaluate the safety and tolerability of escalating single and multiple doses of~     Ibuprofenamine Hydrochloride spray administered as a topical application.~      Secondary Objectives:~      To characterize the single and and multiple pharmacokinetics of escalating doses of~     Ibuprofenamine Hydrochloride spray and its active metabolite ibuprofen as a topical~     application.~   "
20051|NCT02794727|"~     Decreased physical activity is not only associated with multiple chronic medical conditions,~     including obesity, but also with depressed mood, and other negative emotions. As many~     employed adults spend a great deal of time at work where we are predominantly sedentary,~     strategies to increase physical activity at work are being pursued to help improve the~     physical and mental health of Americans. This 17 week randomized controlled trial will~     investigate changes of occupational physical activity in three groups: those provided with a~     FitBit® but not able to monitor their activity level, and those provided with activity goals~     and individual physical activity challenges, and those who do not use a FitBit®.~   "
20052|NCT02794714|"~     This study compares surgeon's satisfaction of operating conditions and patient's~     satisfaction following laparoscopic gynecological surgeries in two groups of patients, half~     of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular~     blockade.~   "
20053|NCT02794701|"~     Objectives: This study aims to explore the risk profiles among people with silicosis in Hong~     Kong underpinned by the Pittsburgh Mind-Body Center model.~      Design and subjects: This study will adopt a cross-sectional study design with sampling~     stratified by participants' degree of incapability. 320 Chinese people diagnosed with~     silicosis and registered with the Pneumoconiosis Compensation Fund Board will be recruited.~      Data collection: A demographic data sheet and the St. George's Respiratory Questionnaire~     will be used to collect the socio-demographic and clinical characteristics of the~     participants. The behavioral factors (smoking, drinking, physical activity level,~     consumption of vegetable and fruits and plasma vitamin C level) as well as the psychological~     risk factors (anxiety and depressive symptoms, and social support) will be examined by~     validated questionnaires. Biological and physiological parameters, including insulin~     resistance, C-reactive protein, hemoglobin, fasting blood glucose and lipid profiles, will~     be ascertained by fasting blood sample.~      Data analysis and expected outcomes: The findings of this study will create the database~     profile of the physical, psychosocial and disease specific aspects among people with~     silicosis in Hong Kong, subsequently forming the empirical basis of an intervention to~     tackle the identified modifiable risks among them.~   "
20054|NCT02794688|"~     RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of~     idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators~     hypothesized that ductal lavage is able to relieve the symptoms and achieve complete~     response, with shorter recovery time than oral intake of antibiotics or corticosteroids~     treatments. This single arm, observational, case series, pilot study is going to evaluate~     the effectiveness of ductal lavage in patients with non-lactational IGM or PD.~   "
20055|NCT02794675|"~     The purpose of this study is to explore the use of a treatment called interstitial~     brachytherapy for patients who have a high risk resectable (able to be treated with surgery)~     recurrent head and neck cancer.~      Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them~     into a specific place on your body. This study is using Cesium-131 permanent interstitial~     brachytherapy.~      Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research~     studies to show how effective it is for head and neck cancer. The goal of this study is~     determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall~     survival as well as to assess possible side effects.~   "
20056|NCT02794662|"~     The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at~     birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared~     with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations~     less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention.~      This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to~     oxygen environment or nasal cannula oxygen using stratified permuted block design. Following~     a 24 hour period on the first intervention, infants will cross over to a 24 hour period on~     the second (alternative) intervention before crossing back to the first intervention for a~     further 24 hours and then back again to the second (alternative) intervention for a further~     24 hours.~   "
20057|NCT02794649|"~     To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1),~     idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the~     number of species and diversity of the microbial populations and pathway for oxalate~     metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by~     gut bacteria.~   "
20407|NCT02790073|"~     To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and~     other parameters of therapeutic response in haemodialysis patients with calciphylaxis~     (calcific uraemic arteriolopathy, CUA).~   "
20058|NCT02794636|"~     The primary objective of this study is to quantify and compare the prevalence of adverse~     events (AEs) in patients with stage III melanoma before and after initiation of interferon~     (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and~     resource utilization before and after IFN initiation among patients with stage III melanoma~     in a real-world setting.~   "
20059|NCT02794623|"~     Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the~     general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2~     percent of the population. Tinnitus therapy is based on counselling, cognitive and~     behavioural therapies in combination with sound therapies which mostly rely on masking.~      For cochlear implant candidates, the ability to use hearing aids and maskers is limited by~     the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67~     to 100% with a mean of 80%.~      In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use~     of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs~     when the implant is switched off. While the benefits of CI implantation on tinnitus are well~     documented, there is a group of recipients where tinnitus remains a concern in the implanted~     ear post-operatively.~      The primary aim of this study is to investigate the benefits of using tinnitus masking via a~     CI sound processor that optimises tinnitus suppression with minimal annoyance to the user.~     Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of~     tinnitus in recipients.~   "
20060|NCT02794610|"~     Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.~      Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before~     cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will~     be subjected to detection of presence and level of tacrolimus.~   "
20061|NCT02794597|"~     Recent research suggests that women with substance use disorders may be at a higher risk of~     unintended pregnancy. There is a paucity of interventions specifically focused on this~     population. Through using mixed methods, this study proposes to develop a brief peer-led~     intervention (based on the Health Belief Model) to prevent unintended pregnancies among~     women entering opioid medication-assisted treatment; to assess acceptability, feasibility~     and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses~     to identify the HBM constructs that are most influential on use of long-acting reversible~     contraception methods. Future research would include testing the intervention in a larger~     scale trial and with other populations.~   "
20062|NCT02794584|"~     Ventricular septal defect (VSD) is one of the most common pediatric congenital~     malformations. In recent years, in view of the rapid rise of transthoracic minimally~     invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of~     perioperative its effectiveness and safety has already become an important issue that must~     be solved. On the basis of echocardiography, integrating with characteristics associated~     critical care, the investigators focus on precision assessment of perioperative~     effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with~     conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).~   "
20063|NCT02794571|"~     This first-in-human open-label, multicenter, dose-escalation study is designed to evaluate~     the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab in~     participants with locally advanced, recurrent, or metastatic incurable tumors for whom~     standard therapy does not exist, has proven to be ineffective or intolerable, or is~     considered inappropriate, or for whom a clinical trial of an investigational agent is a~     recognized standard of care.~   "
20064|NCT02794558|"~     Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR~     Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas~   "
20065|NCT02794545|"~     Although combination antiretroviral therapy (cART) can significantly reduce morbidity and~     mortality, it still fails to eradicate HIV. Given the difficulty for eradication of HIV,~     functional cure is more likely to achieve the goal. In recent breakthrough scientific~     reports, there already existed several examples of HIV-infected cases achieving the status~     of functional cure only through early administration of cART in newborns or early infected~     cases. From Taiwan centers for disease control (CDC) reports and our clinical experiences,~     more and more young men got HIV infection and the most important finding is the~     investigators can find some of them are newly infected, let's say, within six months.~   "
20066|NCT02794532|"~     Pre-oxygenation with high-flow nasal cannula oxygen has been evaluated in a limited number~     of studies and seems to be better than traditional preoxygenation with a tight fitting mask.~     Oxygenation with high-flow nasal cannula in apnea demonstrates that this could be done~     safely for up to 25 mins with preserved saturation. Based on this, the investigators want to~     evaluate whether this novel concept of preoxygenation can prolong the time to desaturation~     in emergency anesthesia while securing a possibly difficult airway. This may reduce the~     number of hypoxic events during intubation. This novel concept has already been tested in~     clinical practice in certain cases but not during rapid sequence induction for acute~     surgery.~      Objectives and Purpose The general purpose of this project is to compare a new~     preoxygenation technique based on humidified oxygen in a high-flow nasal cannula with~     traditional preoxygenation with a tight fitting mask during rapid sequence induction~     intubation with focus on gas exchange.~   "
20088|NCT02794246|"~     This will be a single-arm, open-label study. Patients will be enrolled during induction~     therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem~     cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to~     ASCT, and CART-19 will be infused at day ~60 post-ASCT, 3 days after lymphodepleting~     chemotherapy. The primary endpoint is progression-free survival (PFS) after ASCT. As~     detailed below, the study is powered to detect an increase in two-year PFS to ~75% from a~     baseline expectation of 55% based on historical data. Secondary endpoints will evaluate~     CART-19 persistence and function, minimal residual disease, immune correlative endpoints,~     and associations of progression-free survival (PFS) with CART-19 persistence and clinical~     and biologic characteristics of multiple myeloma.~   "
20089|NCT02794233|"~     The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in~     patients of Parkinson disease (PD) as a function of their functional state (lying, sitting~     and walking) and dopaminergic medication intake (levodopa or dopamine agonists).~      The goal is to use DBS measured impedance as a surrogate of the functional and medication~     states of PD patients.~   "
20067|NCT02794519|"~     Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal~     antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The~     continuing unmet need in subjects with asthma refractory to corticosteroid therapy and~     increased understanding of asthma pathogenesis have stimulated the development of targeted~     biologics based on predictive biomarkers. The majority of approaches to date have targeted T~     Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma~     represents an unprecedented approach that has potential to address non-Th2 drivers of severe~     asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled,~     parallel group study will investigate the efficacy of sirukumab compared to placebo in~     subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid~     (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable~     treatment period for individual subjects. Dosing will continue every 4 weeks until week 44~     (inclusive), or until 24 weeks after the final subject has been randomized, whichever the~     sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16~     week Follow Up period. Overall, the duration of participation for subjects who complete the~     full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175~     subjects will be randomized such that 140 evaluable subjects complete the study.~   "
20068|NCT02794506|"~     Background:~      Propolis is a natural resin made by bees from various plant sources. Propolis exerts~     antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and antidiabetic~     properties. The purpose of this study was to assess the adjunctive benefit of propolis~     supplementation in individuals with both chronic periodontitis and type 2 diabetes mellitus~     (T2DM) receiving scaling and root planing (SRP).~      Methods:~      A 6-month randomized blinded clinical trial comparing SRP with placebo (placebo+SRP group,~     n=26) or combined with a 6- month regimen of 400 mg oral propolis once daily (propolis+SRP~     group, n=26) was performed in patients with long-standing T2DM and chronic periodontitis.~     Treatment outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum~     N€-(carboxymethyl) lysine (CML) and changes in periodontal parameters.~   "
20069|NCT02794493|"~     RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese~     Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast~     cancer.~      PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine~     Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome~     in patients who are receiving capecitabine for colorectal or breast cancer.~   "
20070|NCT02794480|"~     The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA~     Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by~     subject with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI),~     a GSK MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label,~     cross-over study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess~     correct inhaler use. No active drug will be used in this study in order to prevent any~     drug-related effects. Approximately, 152 subjects will be randomized to receive ELLIPTA DPI~     inhaler and 152 will be randomized to receive one of the MDI inhalers, for use during the~     first period (P) (approximately 28 days). At Visit 2 (Day 28) all subjects previous~     receiving the ELLIPTA DPI will be randomized to receive one of the MDI inhalers and all~     subjects who received a MDI in the previous period will receive the ELLIPTA DPI for use~     during second period (approximately 28 days). Subjects will continue taking their asthma~     maintenance treatment and limited rescue albuterol MDI during the entire 56-day study~     period.~      ELLIPTA is a registered trademark of the GSK group of companies.~   "
20071|NCT02794467|"~     The primary objective of the study is to assess the efficacy, safety, and tolerability of~     epelsiban compared with placebo in treatment of women with adenomyosis.~      This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with~     an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams~     (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The~     study will be composed of three periods: screening, treatment, and follow-up and the total~     time a subject will be in the study will be approximately 6 months.~   "
20072|NCT02794454|"~     Sexual function is a part of a normal healthy life and considered to be essential for~     mental, physical and marital well-being. Any derangement in normal function though is a~     distressing situation for the individual, is often not reported due to embarrassment or due~     to social stigma. Sexual disorders in men are categorized according to the stage of sexual~     response affected in terms of disorders of erectile function, ejaculatory function or~     libido, albeit there is considerable potential for overlap amongst the disorders. The use of~     current intervention has many side-effects and has been prohibited in cardiovascular~     condition and also to be taken with caution with other medical condition.~      This has led to the development of multiple alternate therapies which are helpful for a~     limited number of cases but the major concern for all these therapies is their late onset of~     action and not having a sustained effect.~   "
20073|NCT02794441|"~     Migraine recurrence is common amongst pediatric patients being discharged from the emergency~     department after treatment for migraine. Despite the commonality of migraine recurrence~     within the week following discharge, no known effective therapies are available in the~     pediatric population, though dexamethasone has been established as efficacious in the adult~     migraine population. The proposed study will randomly assign children and adolescents~     visiting the emergency department (ED) for migraine to receive either one dose of oral~     dexamethasone or oral placebo. Twenty patients will be recruited to this randomized,~     double-blind, pilot trial over a 6 month period, and the aim of the study will be to~     determine the feasibility and acceptability of the protocol.~   "
20074|NCT02794428|"~     A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or~     DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high~     risk regions of Latin America.~   "
20075|NCT02794415|"~     The primary aim of this research is to evaluate a community-based exercise (CBE)~     intervention for adults living with HIV within the community with the goal of reducing~     disability and enhancing health (cardiopulmonary, strength, weight and body composition, and~     neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery,~     coping) for adults living with HIV.~   "
20076|NCT02794402|"~     Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell~     function) is part of a collaborative project funded by the Seventh Framework Programme of~     the European Commission aiming to develop innovative therapeutic strategies by increasing~     pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young~     obese individuals.~      The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind~     these alarming figures is mostly a changing environment with a more sedative lifestyle and~     supply of excess food. However, specific gene mutations have also been linked to obesity and~     new genes are continuously being discovered. There are very few effective means of~     intervention in children with obesity available today. Obesity is closely associated with a~     number of related metabolic diseases and some children with obesity develop the metabolic~     syndrome at an early stage in life. Individuals with obesity have an increased risk of~     developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood~     obesity, some children will develop T2DM already in their adolescent years with huge impact~     on their long-term health and life expectancy.~      Lifestyle modification interventions, including behavioural treatment, diet modification and~     physical activity, are cornerstones of primary and secondary prevention/treatment of~     pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist~     approved for use in adults with T2DM to improve glycemic control. A pilot study with~     exenatide treatment in non-diabetic children and adolescents with severe obesity showed a~     reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell~     function were observed.~      The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle~     intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with~     obesity. The lifestyle intervention includes regular nutritional and psychological support~     at 4 occasions during the study as well as physical activity on a weekly basis.~     Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary~     objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline~     to the 6 months visit between the two treatment arms.~      The study includes males and females of age 10-18 years and 5 months with BMI SDS >2.0 or~     age-adapted BMI >30 kg/m2.~   "
20077|NCT02794389|"~     The investigators will examine whether compulsivity in those who score above-average (but~     below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of~     N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in~     individuals with other compulsive disorders, such as trichotillomania and addiction, so this~     research investigates whether a short period of time taking N-acetyl cysteine changes~     compulsivity, measured using cognitive tasks and questionnaires.~   "
20078|NCT02794376|"~     This study investigates the effectiveness of a 6 week mindfulness intervention in reducing~     symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment.~     Participants will be randomly allocated to an immediate treatment group and a waiting list~     control group.~   "
20079|NCT02794363|"~     15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic~     specializing in vulvar disorders. This study consists of a 2 week screening period and a~     12-week treatment period. Participants will receive two separate treatments of autologous~     platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after~     the second autologous platelet rich plasma injection~   "
20080|NCT02794350|"~     The cognitive profile of older adults with a severe to profound hearing impairment is~     determined by means of the Repeatable Battery for the Assessment of Neuropsychological~     Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear~     implantation. In this prospective, longitudinal study the participants are tested~     preoperatively, at six months and twelve months postoperatively and from then on yearly up~     to 10 years after implantation. In addition to the RBANS-H an audiological examination and~     an semistructured interview is conducted concerning the cochlear implant use and the~     self-reliance of the patient and subjective questionnaires are filled out by the subjects to~     assess quality of life and hearing benefit.~   "
20081|NCT02794337|"~     Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable~     disease. In the last decade results of randomized trials and a subsequent metaanalyses~     established transarterial chemoembolization (TACE) or systemic chemotherapy (sorafenib) as~     standard of care. However, TACE alone is not a curative approach. The two year survival~     following TACE ranges from 31-63% with almost 100% patients developing disease progression~     after treatment. There is need to investigate additional therapeutic options that would~     consolidate the initial response to TACE. A recent metaanalyses concluded that addition of~     high dose radiation to TACE results in 10-35% improvement in two year overall survival.~     However as results of metaanalyses were based on studies with small sample size, unclear~     randomization procedure and heterogenous dose of radiation, the need for conducting a high~     quality randomized study was highlighted The present study is designed to investigate the~     role of high dose conformal radiation as consolidation therapy after TACE in patients with~     nonmetastatic unresectable HCC.~   "
20082|NCT02794324|"~     Radiotherapy (RT) has a major curative role in women with early breast cancer, and is~     recommended routinely after lumpectomy and selectively after mastectomy. It has contributed~     to a halving of breast cancer mortality in the UK over the last 2 decades despite~     ever-rising cancer incidence. RT in women with left-sided tumours often exposes the~     underlying heart to a damaging dose. The heart is very sensitive to RT, and there were 1-2~     deaths from heart disease for every 100 breast cancer patients treated during the 1960s-70s.~     The situation has improved in recent years, but standard RT techniques still deliver~     significant radiation doses to heart tissue.~      Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in~     deeply and to hold their breath for about 20 seconds while RT is given. The downward~     movement of the diaphragm pulls the heart away from the RT beam. In the other technique,~     women lie on their fronts, instead of on their backs as they normally do for breast RT. In~     this position, the breast falls away from the rib cage and reduces exposure of the heart.~     Neither technique is routinely available to women receiving breast RT in the UK for reasons~     that this research aims to address. The investigators need to: 1) confirm that patient~     position can be reproduced with millimetre precision every day using these techniques, 2)~     minimise costs of equipment, time and personnel required to support such techniques, 3)~     select the most appropriate technique for different patients and 4) train staff in centres~     across the UK to deliver techniques safely and effectively. By addressing all of these~     issues, the study aims ultimately to make heart-sparing RT available to all UK women that~     might benefit from treatment, thereby significantly reducing the burden of heart disease in~     breast cancer survivors.~   "
20083|NCT02794311|"~     The purpose of this study is to specify the psychological, cognitive, neuro-functional and~     genetic profile associated with binge drinker behaviors among young adults. Results will~     help identifying more precisely vulnerability factors associated with this pattern of~     alcohol consumption and guiding prevention efforts.~   "
20084|NCT02794298|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in younger~     people, compared to sham tDCS.~   "
20090|NCT02794220|"~     The purpose of this study is to assess the amount of nicotine that is absorbed into the~     blood stream following the use of a new Electronic Cigarette device called the CN electronic~     cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared~     to the amount of nicotine delivered from smoking a regular cigarette and from using the~     Nicorette® Inhalator.~      Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering~     nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful~     combustion products contained in tobacco smoke.~      Electronic cigarettes are readily available in many markets, and may contain significant~     quantities of nicotine. However, they are not regulated as medicines, and their~     manufacturers can make no medicinal claims about them.~      Such products are unregulated, having not been subjected to regulatory review by either the~     Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.~      It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an~     application to the MHRA for the CN Electronic Cigarette, in order to make a high quality,~     regulated product available. Males aged 18-65, who smoke and who have no intention of~     stopping smoking during the trial are eligible to take part in this study. The study consist~     of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on~     days 1, 2, 3 and 4 with a post study visit on day 5.~   "
20091|NCT02794207|"~     The primary objectives of this study are to identify what outcomes related to the management~     of neutropenia are most important to children with AML and their caregivers. Patients who~     have completed treatment for AML and their caregivers will be interviewed in order to better~     understand the impact of neutropenia management on children with AML and their families. The~     primary outcome of these interviews is to identify patient-centered outcomes related to~     neutropenia management to include in a subsequent comparative-effectiveness analysis.~     Investigators will use these data to develop a structured survey for administration to~     prospectively identified patients in subsequent studies.~   "
20092|NCT02794194|"~     After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual~     symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint giving~     away or decreased function. Recently, Whole Body Vibration (WBV) training has been~     introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on~     unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was~     to investigate the effects of a 6-week WBV training on an unstable surface on body~     composition, balance, strength and reflex and muscle activity of ankle muscles in~     recreational athletes with CAI.~   "
20093|NCT02794181|"~     Background:~      Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild~     illness. But in pregnant women it can cause serious birth defects to the baby. The virus can~     also spread by blood transfusion and sexual intercourse. This is why the U.S. Food & Drug~     Administration (FDA) recommended that people should not give blood if possibly exposed to~     Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika~     virus. These can cause severe reactions if passed through transfused blood.~      Donated blood is usually not tested for these three viruses. Researchers want to count the~     infections in people who have been exposed because of travel or sexual exposure. They want~     to learn the risk these viruses might pose to the U.S. blood supply. They also want to study~     the natural history of these viruses by following infected people over time.~      Objective:~      To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply.~      Eligibility:~      Adults age 18 or older who were turned down for donating blood because of possible exposure~     to certain viruses.~      Design:~      Participants will have blood and urine tests. They will answer questions about their travel.~      They will be called in about a week with virus test results.~      Participants with negative results do not have any more study visits.~      Participants with positive results will be asked to stay in the study for 6 months. They~     will have weekly clinic visits and tests until results are negative for 2 straight weeks.~     Once test results are negative, they will have monthly visits. Visits will include physical~     exams, blood and urine samples, and optional semen samples from men.~      Most people will have 3-4 weekly visits and 5 monthly visits....~   "
20094|NCT02794168|"~     This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome~     in patients with moderate and severe traumatic brain injury. Half of the participants will~     receive Ronopterin (VAS203), while the other half will receive placebo.~   "
20095|NCT02794155|"~     This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study,~     evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro~     Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be~     randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in~     an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the~     randomized treatment in combination with glargine or detemir. Goal to demonstrate that the~     efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin~     Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin~     Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes.~     If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a~     basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a~     basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes~     (≥ 0.4% decrease in HbA1c).~   "
20096|NCT02794142|"~     In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has~     previously been reported. This muscle impairment constitutes an independent prognosis factor~     in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment.~     The mitochondria is a classical producer and target of reactive oxygen species (ROS), and~     may thus constitute a central actor of the skeletal muscle impairment in HD patients.~     Therefore, the aim of the present study is to investigate the role of the muscle~     mitochondrial density on the muscle impairment in HD patients, in comparing the muscle~     mitochondrial density and oxidative stress in HD patients vs. healthy matched controls.~      In order to assess the effect of the oxidative stress and inflammation on the muscle~     impairment in HD patients, muscle function assessements will be performed after renal~     transplantation (which lowers the oxidative stress and inflammation levels) in the HD~     patient group.~      No therapeutic intervention will be tested in the present study.~   "
20097|NCT02794129|"~     Bipolar disorder is a mental disease characterized by mood dysregulation and arises from~     manic, depressive or mixed episodes. The observations of the patient's speech and language~     behaviour due to flight of ideas or loss of goal probably result from an underlying~     disturbance in semantic networks dealing with semantic associations. The aim of our study~     will be to have a better comprehension of thought disorders in bipolar disorder by cognitive~     exploration of semantic processing.~   "
20098|NCT02794116|"~     Aim: To evaluate the clinical survival of fluoride sealants applied in first permanent~     molars affected by Molar-Incisor Hypomineralization (MIH).~      Material and Methods: For this case control study, it was selected 41 first permanent molars~     of the 21 children aged 6-8 years. MIH was classified by one calibrated examiner (kappa~     0.80) according severity of the MIH lesion (EAPD, 2003). Inclusion criteria were FPM with~     MIH or sound (without MIH), fully erupted, and with sealant treatment indication.~      The FPMs were assigned into two groups: G1 - Control group and G2 - MIH group. Both group~     teeth were treated with sealant application (Fluroshield, NY, USA). Clinical follow-up was~     performed at baseline, 1, 6, 12 and 18 months for anatomic form, marginal adaptation,~     retention and presence of caries, according to the United States Public Health Service~     USPHS-Modified by a blinded examiner (kappa 0.80). The Acturial Method was used to evaluate~     the survival of sealants. Statistical analysis compared the ratings of each criterion~     between materials using the Fisher's exact test at a level of significance of 5% (p<0.05).~   "
20099|NCT02794103|"~     Procedural pain is the most intense and often undertreated pain associated with burn~     injuries. The use of analgesics does not always provide optimal relief and is accompanied by~     several side effects. Indeed, children with burn injuries still experience severe pain~     intensity during procedures despite the fact that doses of analgesics used with this~     population has almost doubled in the last twenty years. Current guidelines on pediatric~     procedural pain management recommend the combination of non-pharmacological and~     pharmacological interventions to enhance pain management and decrease the numerous side~     effects of analgesics. Distraction has been identified among the most effective~     non-pharmacological interventions for pain as it diverts the child's attention to an~     attractive element, hindering the perception of the painful stimuli. Virtual reality is a~     method of active distraction that offers the child a multi-sensory immersive interaction~     that found many applications for pain management in adult patients. However, very few~     studies have tested the efficacy of distraction by virtual reality on procedural pain and~     anxiety in children with burn injuries.~      The aim of this study is to assess the feasibility and preliminary efficacy of a virtual~     reality prototype developed specifically for the hydrotherapy room of children under seven~     years old for the relief of procedural pain and anxiety in children with burn injuries.~     HYPOTHESES: a) VR distraction is a feasible non-pharmacological intervention for pain~     management during hydrotherapy, b) VR distraction combined with analgesics is more~     efficacious than standard treatment (analgesics alone) on procedural pain and anxiety~     (hydrotherapy) of young children with burn injuries.~   "
20100|NCT02794090|"~     This study evaluates if usual physical care visits to an outpatient pediatric clinic can be~     replaced with more frequent and shorter Telephone coaching Contacts during 18 months.~   "
20101|NCT02794077|"~     There is no standard third-line systemic treatment for inoperable locoregionally advanced~     recurrent or metastatic nasopharyngeal carcinoma (NPC). We investigated the efficacy and~     safety of metronomic oral cyclophosphamide as third-line treatment or beyond.~   "
20102|NCT02794064|"~     Breast conservation surgery (BCS) is performed on patients with breast cancer with the~     intent to resect and completely remove the tumour while conserving as much of the~     surrounding normal tissue as possible. Currently, there is no way for surgeons to determine~     the adequacy of surgical resection in real-time during surgery; the assessment of surgical~     margins requires histological examination that is not available in real-time and is~     impractical in most clinical cases. This results in a re-excision rate of 23% among Canadian~     women in order to achieve optimal surgical margins. In addition, the presence or absence of~     cancer in tumor draining lymph nodes is recognized as a key element for breast cancer~     staging; however, lymph node dissection can be associated with overtreatment and morbidity~     (nerve damage and post surgical lymphedema) and histological analysis of nodes can be time~     consuming and thus delay subsequent procedures. In an effort to address these issues, we~     have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a~     novel imaging system that performs three complementary imaging modalities (tri-modal):~     ultrasound (US), photoacoustic (PA) and fluorescence (FL).~      This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast~     conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to~     test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall~     goal is to obtain initial information on the technical feasibility of the tri-modal system~     in a peri-operative setting and to confirm the anticipated safety of the procedures.~     Additionally, it will provide initial data on the ability of this system to detect/localize~     primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.~   "
20103|NCT02794051|"~     This study fills a notable gap in the transdiagnostic literature by evaluating whether an~     evidence-based transdiagnostic treatment for emotional disorders such as the Unified~     Protocol for Children (UP-C) is effective for treating childhood behavior problems.~   "
20104|NCT02794038|"~     This study scope is to validate the accuracy and usability of the Soberlink Cellular Device~     in comparison to a predicate device, BACtrack S80 Pro.~   "
20105|NCT02794025|"~     The purpose of this study was to investigate the effect of esmolol on hemodynamic~     parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis~   "
20106|NCT02794012|"~     The purpose of this study is to evaluate the association of Rheumatoid Arthritis~     (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid~     Arthritis. Subjects will undergo periodontal and joint examinations, as well as collection~     of body fluids to measure Rheumatoid Arthritis-related antibodies.~   "
20148|NCT02793466|"~     This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor~     which stimulates the patient's own immune system to act against cancer cells in children and~     adolescents. This trial will assess the safety and tolerability of Durvalumab in children~     and adolescents and also study how Durvalumab is processed in their bodies.~   "
20107|NCT02793999|"~     The purpose of this study is to improve the ability of the investigators to monitor brain~     health in newborn babies at risk of brain injuries. The researchers will be using an~     investigational system of devices to non-invasively (that, is, without penetrating the~     skin), measure the amount of oxygen going to and being used by the brain. They will be~     taking some bedside research measurements during the babies' stay at the hospital. With~     these measurements, the intention is to study the role of oxygen in brain injury and test~     the efficacy of the research device and its potential as a permanent bedside diagnostic~     device.~   "
20108|NCT02793986|"~     With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To~     offer an satisfied surgery process for patients, a proper sedation is necessary. So in this~     study, we want to investigate the influence of different levels of sedation on outcomes of~     patients received hip replacement surgery . And try to find out a suitable level of sedation~     level.~   "
20109|NCT02793973|"~     A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has~     been estimated at 40-70%. Those who have been suffered from limping for a long time may lead~     to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb~     triple view of x-ray is considered to be the current technique for determining LLD, it is~     costly and time consuming that not every hospital can afford it, and in case of radiograph,~     the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical~     assessment method by gathering exterior parameters to build up a Regression model for~     measuring the discrepancy and determining LLD accurately.~      While using shoe lifts to correct discrepancy is the easiest conservative intervention for~     LLD, there are still many controversies on how much height should be added clinically and~     academically. The optimal height should be added depends on feedbacks from users and gait~     performance. The best gait performance can be measured from kinematic performance of center~     mass of body during walking. Therefore, this project wants to compare treatment responses~     between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in~     shoe lift height correction through triple view of x-ray and given optimal shoe lift height~     correction through analyzing kinematic performance of center mass of body.~   "
20110|NCT02793960|"~     This is a single-center study to investigate the effects of a topical cream on patients 12~     years of age and older that have been diagnosed with epidermolysis bullosa.~   "
20111|NCT02793947|"~     The purpose of this study is to determine the efficacy and safety of a peri-incisional~     multimodal injection for post-operative pain control following operative management of femur~     fractures. Enrolled subjects will be prospectively randomized into either the~     peri-incisional injection or control cohorts. Patients will be treated with standard of care~     surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture~     pattern. The patients randomized into the injection cohort will receive an intra-operative~     injection with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local~     superficial and deep peri-incisional tissues while under general anesthesia. Visual analog~     pain scores will be collected every 4 hours after surgery for the first two post-operative~     days. Total narcotic consumption will also be recorded over eight hour intervals for the~     first two post-operative days. Medication related side effects will be monitored. The~     investigators hypothesize that the peri-incisional injection cohort will demonstrate an~     improved pain profile and utilize less parenteral narcotic analgesia in the early~     post-operative period.~   "
20112|NCT02793934|"~     The Programme is focused on adult patients of any gender and age more than 18 y.o., with the~     next conditions:~        1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage -~          specialty neurology)~        2. Acute myocardial infarction (AMI, specialty cardiology)~        3. Patients after total hip replacement (THR, specialty orthopaedia) The program is~          performed in the in-patient and out-patient rehabilitation departments in 13 regions of~          the Russian Federation (total 244 departments).~   "
20113|NCT02793921|"~     This randomized control trial will examine whether a well-controlled and monitored~     site-based exercise intervention, initiated before beginning aromatase inhibitor (AI)~     therapy, improves cognitive function in postmenopausal women with early-stage breast cancer~     and will explore whether neuroimaging metrics of brain health, pro-inflammatory biomarkers~     and symptoms (fatigue, sleep problems, depression, anxiety) mediate the effects of exercise~     on cognitive function. Furthermore, the study will explore whether the magnitude of the~     improvements in cognitive function are modified by estradiol levels.~   "
20114|NCT02793908|"~     The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone~     (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day;~     Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction~     in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time~     intercourses or COS/IUI cycles.~   "
20115|NCT02793895|"~     The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting~     post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during~     the early, sub-acute post-operative period. The population includes cardiac surgical~     subjects who have either developed or are at risk for developing new onset POAF/AFL and who~     are at risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure,~     hypertension, age ≥75 years (2 points), diabetes mellitus, previous stroke/transient~     ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female))~     score. These subjects must not have had a history of AF/AFL before cardiac surgery.~      The intervention group will undergo 30 days of continuous cardiac rhythm monitoring with an~     adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system). The control~     group will receive usual care, which does not involve planned cardiac rhythm testing within~     the first 30 days after study randomization. The primary outcome is documentation of~     sustained atrial fibrillation or flutter within the first 30 days after randomization. In~     addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm~     monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system at 6±1 months after~     their index cardiac surgery.~   "
20116|NCT02793882|"~     1.0 Background & Introduction Positron emission tomography / computer tomography (PET/CT) is~     a nuclear medicine procedure based on the measurement of positron emission from~     radiolabelled tracers. This technology allows biologic processes to be visualized and~     measured on whole body images. Common radiotracers in use today in the USA and Europe are~     radiolabelled choline derivatives such as the analogs 18F-fluoromethylcholine (FMCh) and~     18F-fluoroethylcholine (FECh), or more broadly FCH. Both of these fluorinated choline~     analogs have been extensively studied and display seemingly identical biological,~     radiopharmaceutical and radiochemical properties. Both have been extensively studied in~     human prostate cancer, with FMCh having slightly more published data than FECh. Imaging with~     radiolabelled choline derivatives is used to determine sites of abnormal choline metabolism~     and can be used to characterize prostate cancer, for which there is extensive data in the~     literature. PET/CT with radiolabelled choline derivatives is considered standard of care by~     some experts where available, however at the JGH, anatomic imaging with CT and MRI, and bone~     scan are the current diagnostic imaging modalities in use for this patient population.~     Prostate cancer cells have increased choline uptake compared to normal tissues, forming the~     molecular basis for this technique. The Gleason score, a histopathologic measure of tumor~     aggressiveness, is one of the most important prognostic factors in the disease. The~     objective of this study is to evaluate if the degree of uptake measured by maximum standard~     uptake value (SUVmax) on FCH PET/CT in prostate cancer correlates with Gleason score at~     initial biopsy.~      2.0 Study Objectives The objective of this study is to evaluate if the patient-wide SUVmax~     on 18F-FCH PET/CT in locoregional and metastatic prostate cancer correlates with~     histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will~     correlate positively with Gleason score. This is of interest because non-invasive risk~     stratification may be possible in the future.~      3.0 Study Design This will be a single-site JGH-only open label study in which one (1)~     18F-FCH PET/CT will be performed on study participants. A PET/CT scan takes about 3 hours.~      4.0 Safety & Ethics The radiation dose to patients from fluorinated choline derivatives~     compares favorably to the major PET tracer in widespread clinical use,~     18F-fluorodeoxyglucose (18F-FDG). The safety of fluorinated choline derivatives is not~     disputed and the investigators expect the number of adverse events in this study to be at~     (or near) zero. There is no established toxicology for diagnostic doses of fluorinated~     choline derivatives.~      There are no salient ethical considerations identified. The treating physicians are free to~     order any diagnostic or therapeutic intervention on study patients, and care will not be~     modified or restricted in any way. Treating physicians are free to incorporate information~     acquired with this study or discard it if it is not relevant. Care of the patients may be~     improved with additional information provided by FCH PET/CT, but it is otherwise unchanged.~     No vulnerable populations will be included in the study.~      5.0 Confidentiality All information (medical history, physical examination, and PET/CT~     results) will be kept strictly confidential and only authorized personnel will have access.~     The reports of the PET/CT will be contained in a password protected radiology & nuclear~     medicine RIS database (RadImage) where all other diagnostic imaging reports are securely~     stored. Clinical PET/CT reports will be stored indefinitely, whereas all other study data~     will be kept locked by the PI and destroyed after 10 years.~      6.0 Population, Sample Size and Recruitment A maximum of 225 competent adult male medically~     stable prostate cancer patients with available Gleason Scores will be entered into the~     study. Patients will be recruited by urologists in the clinical setting. Initial contact and~     consent will be by the department of urology.~   "
20408|NCT02790060|"~     Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a~     blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3~     occasions in a 2 week time period, in addition to the filling of 5 questionnaires including~     fear of hypoglycemia-2 questionnaire.~   "
20117|NCT02793869|"~     Congenital cataracts (CC) are the leading cause of childhood visual disabilities and~     treatable childhood blindness worldwide1. CC patients have a wide range of presentations of~     lens opacities and are generally categorized into several groups based on the etiologies,~     anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also~     frequently complicated with other anterior segment abnormalities due to their close~     anatomical relationships and similar developmental origins. Lens opacities in different~     positions may be related to specific anterior segment abnormalities; for example, anterior~     polar cataracts are associated with greater corneal astigmatism (CA). However, no studies~     have systematically related the position of lens opacities to specific anterior segment~     abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and~     a lack of awareness of these important relationships.~   "
20118|NCT02793856|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic non-small cell lung cancer. Blood samples will also be collected for research~     purposes.~   "
20119|NCT02793843|"~     Background: Common adverse side effects related to the use of neuraxial opioids in the~     obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor~     antagonists, in particular ondansetron, have been identified as possible antipruritic~     agents. It was reported that dexamethasone plus ondansetron is more effective than~     ondansetron for prevention of postoperative nausea and vomiting but no additional effect on~     treating pruritus.~      Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron~     versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative~     nausea and vomiting (PONV).~      Methods: A prospective randomized double blind study that will be conducted between June~     2016 and June 2017. Patients will be randomly allocated into two groups. The first group~     will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV~     ondansetron plus 8 mg dexamethasone.~   "
20120|NCT02793830|"~     This study evaluates the feasibility and acceptability of using mobile applications to~     improve medication adherence. Participants in the experimental group will receive~     educational materials and daily reminders through mobile applications. While, participants~     in the control group will receive only educational materials. After the intervention,~     interviews will be conducted among participants through phone calls.~   "
20121|NCT02793817|"~     The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0%~     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.~   "
20122|NCT02793804|"~     This study consists of a Cluster Randomised Trial (CRT) of community and facility-based~     HIVST distribution by the Society for Family Health (SFH) in multiple rural and peri-urban~     settings. The study will take place in 6 matched pairs of health facilities and their~     catchment areas have been selected for study inclusion in collaboration with the district~     medical office (DMO). One clinic catchment area from each pair will be randomly allocated to~     the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In~     the HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male~     Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at~     the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be~     conducted as currently.~   "
20123|NCT02793791|"~     The aim of this study is to determine that for hepatic dysplastic nodules in patients with~     chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive~     ablation therapy can reduce the incidence of hepatocellular carcinoma.~   "
20124|NCT02793778|"~     The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and~     maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's~     Disease receiving induction anti-Tumor Necrosis Factor (TNF) therapy (infliximab,~     adalimumab)~   "
20125|NCT02793765|"~     This clinical study will evaluate the role of combination therapy of docetaxel followed by~     Provenge for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate~     cancer that is resistant to medical or surgical treatments that lower testosterone). The~     purpose of this study is to look at the combination therapy of docetaxel followed by~     Provenge to correlate the immunological biomarkers with clinical results for therapy.~     Biomarkers are genes, proteins and other molecules that affect how cancer cells grow,~     multiply, die and respond to other compounds in the body. The study drugs are approved by~     the Food and Drug Administration (FDA).~      Treatment will be administered on an outpatient basis. Patients will receive 6 cycles of~     docetaxel followed by Provenge. Docetaxel is an antineoplastic (chemotherapy that affects~     cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a~     1-hour infusion every 21 days on Day 1 for 6 cycles. Provenge is an immunotherapy (vaccine~     made from patient's own blood cells) that reprograms immune cells to attack cancer. A course~     of therapy consists of three doses of Provenge administered at 2-week intervals.~      The strategy aims to determine whether cytokine production and T cell infiltration of tumor~     cells could favor regression using a combination of chemotherapy plus vaccine. Tissue~     endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at~     the end of each therapy. Prostate cancer tissue infiltrates will be studied for expression~     of CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological~     endpoints will be secondary antigen spread and various cytokine biomarkers.~   "
20126|NCT02793752|"~     The need for non-invasive biomarkers of oocyte competency has become urgent as women~     increasingly delay attempts at childbearing. The aging process is complex and includes~     impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and~     activity of several cell-signaling systems. Cumulus cells form an intimate association with~     the oocyte in the follicle, and they can have a significant impact on oocyte meiotic and~     developmental competence. In the IVF lab, the clump of cumulus cells is typically cut away~     from the oocyte immediately after an oocyte retrieval procedure, and then the cumulus cells~     are discarded. Measuring the mitochondrial respiratory activity of cumulus cells may serve~     as a non-invasive biomarker for oocyte competency and a predictor of reproductive success in~     IVF patients in the future.~   "
20409|NCT02790047|"~     The aim of this study to investigate the efficacy of a home-base exercise program with a new~     conical PEP device on physical performance and health related quality of life in COPD~     patients.~   "
20127|NCT02793739|"~     Fingers are a part of the body that are often subject to increased signs of aging due to~     physical use, trauma and exposure to the environment. The FDA's recent approval of a dermal~     filler, calcium hydroxylapatite, in hands has led to increased patient demand for hand~     fillers which, in turn, has led to the question of rejuvenation of the dorsal fingers. Due~     to the different anatomy of the fingers than the dorsal hand plus the new demand to improve~     the entire hand plus the finger area, we aim to characterize the best approach. Youthful~     fingers are devoid of wrinkles and often have fuller contours thus hiding the knuckles~     (proximal and distal interphalangeal joints). With aging and loss of subcutaneous tissue~     volume, fingers become wrinkled, look more skeletal, almost emaciated, and joints become~     much more prominent, all aesthetic features often disliked by patients. By augmenting the~     volume in the dorsal fingers, it is possible that the visibility of such bony structures~     will be decreased, wrinkles will become smoother, and a more youthful appearance of the~     fingers will be restored.~      There have been no published reports, to these investigators' knowledge, of the use of~     injectable filler into the dorsal fingers for three-dimensional volume correction. The use~     of exogenous hyaluronic acid (HA) filler in the fingers would be off-label. Given that HA~     filler has been used safely and effectively in many areas of three-dimensional volume~     restoration throughout the body, the investigators believe the HA filler may be used to~     effectively and safely correct volume loss in the fingers. The investigators hope that this~     study will present current, state of the art, never before reported technique, safety,~     efficacy and patient satisfaction of HA filler in this region.~   "
20128|NCT02793726|"~     Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled~     in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic~     Resonance).~   "
20129|NCT02793713|"~     Surgical removal of a tumour in the lung offers the best chance for survival in early stage~     lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to~     the lymph nodes; rendering the staging process extremely important. The evaluation of these~     lymph nodes is thought to be best completed using Endobronchial Ultrasound (EBUS), a~     procedure in which several lymph nodes are sampled and send to pathology to determine~     whether or not it is malignant. More recently, studies have observed that there are clear~     differences in the characteristics of cancerous and benign (non-cancerous) lymph nodes, and~     so there has been great interest in creating a list of criteria that can determine whether a~     node is malignant. This study aims to prospectively validate a previously proposed score~     based on observed characteristics of lymph nodes during an EBUS procedure relating to~     pathology-confirmed results. To test this, the results of the lymph node samples and the~     observed score will be compared for agreement. If the investigators find that the scoring~     system can accurately predict which lymph nodes are cancerous, it would provide the evidence~     to establish the score as a standard procedure during cancer staging.~   "
20130|NCT02793700|"~     Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates.~     Antenatal glucocorticoids have been used clinically in women with threatened preterm birth~     to accelerate lung maturation for more than 40 years. The current treatment strategy for~     women with threatened preterm delivery is for a standard, one size fits all dosing with~     either betamethasone (BMZ) or dexamethasone. It is well known that pregnancy introduces~     additional variability in response to medication therapy with different physiological~     changes and alterations in the activity of drug metabolizing enzymes. The objective of this~     project is to evaluate the pharmacokinetic (PK), pharmacodynamic, and pharmacogenetic~     parameters of betamethasone (BMZ) and determine the differences in response and benefit in~     pregnancy. An individualized dosing approach to medications in pregnancy, such as BMZ, is~     crucial to optimize efficacy of this important medication.~   "
20131|NCT02793687|"~     A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group~     study in patients with stroke~   "
20132|NCT02793674|"~     High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to~     decrease the effort of breathing (EOB) in patients with a wide variety of respiratory~     diseases in the pediatric intensive care unit. While its use has shown association with~     decreased rates of mechanical ventilation, there is a paucity of data examining its direct~     effect upon objective measurements of EOB. This study will aim to evaluate objective~     measurements of EOB in response to different levels of HFNC support, characterize the~     natural course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary~     to the administration of supplemental medical therapies used in conjunction with HFNC, and~     compare different physiologic metrics for quantifying EOB in patients on HFNC.~   "
20133|NCT02793661|"~     The Strength study aim to evaluate the use of the RenalGuard device to protect the patients~     at high risk to develop acute kidney injury following a complex cardiovascular intervention~     requiring a high volume of contrast.~   "
20134|NCT02793648|"~     The trial aims to treat depression. The incidence of major depression in the elderly~     accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in~     general is studied. Besides depression in the elderly presents with cognitive impairment,~     impaired physical and social functioning, and predisposes to suicide. These are patients who~     often have multiple conditions and be taking numerous psychopharmacological treatments which~     hinders further treatment. The clinical trial will analyze the improvement in~     neuropsychiatric symptoms through different instruments The Beck Depression Inventory (BDI),~     State-Trait Anxiety Inventory (STAI), Life Events (AV), World Health Organization Disability~     Assessment Schedule 2.0 (WHODAS 2.0), Wechsler Memory Scale (WMS-III), Mini mental state~     examination (MMSE), Clinical Global Impression (CGI) and metabolic changes in the blood test~     measurements; after 12 weeks of antioxidant (Ascorbic acid and Tocopherol) treatment or~     placebo, and then after 24 weeks on active treatment with the antioxidant combination~     (Ascorbic acid and Tocopherol).~   "
20149|NCT02793453|"~     Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide.~     Etiopathological process involved in initiation and progression of these multifactorial~     diseases are not well understood, explaining the huge clinical forms variability and the~     complexity of the currently used classification of periodontal diseases. Recently, the~     implication of antimicrobial peptides (AMPs) have been suggested as potential track of~     explanation for periodontal diseases pathogeny. The here presented study explore the level~     of expression of genes coding those peptides by studying periodontal smears obtained from~     healthy and periodontitis patients.~   "
20135|NCT02793635|"~     The purpose of this study is to assess the use of Indego as a gait training tool for~     subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who~     have preserved lower extremity function. It is hypothesized that subjects with complete or~     incomplete paraplegia who have preserved their lower extremity function will experience~     functional improvements after gait training with the Indego exoskeleton.~      Subjects will complete a total of fifteen (15) sessions which include a combination of the~     following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and~     Post-Assessment.~      The aim of this study is to measure the impact of gait training with the Indego device on~     body structure, function, and participation. Additionally it will assess the perceptions of~     physical therapists and subjects with SCI on the effectiveness of gait training with the~     Indego exoskeleton in subjects with preserved limited function.~   "
20136|NCT02793622|"~     This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected~     pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation~     will be randomized in equal proportions to one of two intermittent preventive treatment in~     pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly~     dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP~     placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant~     women will end approximately 6 weeks after giving birth. All children born to mothers~     enrolled in the study will be followed from birth until they reach 12 months of age.~   "
20137|NCT02793609|"~     Randomized trial comparing double balloon catheter for induction of labor between in- and~     outpatient groups.Investigators assess feasibility, clinical effectiveness and patient~     acceptability of outpatient versus inpatient catheter for induction of labor.~   "
20138|NCT02793596|"~     In this study, we will set out to confirm the reliability of epidural waveform analysis~     (EWA) as an adjunct to loss of resistance for obstetrical epidural blocks.~   "
20139|NCT02793583|"~     This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in~     combination with another study drug called ublituximab compared to TGR-1202 alone as a~     possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come back or that has~     not responded to standard treatment.~   "
20140|NCT02793570|"~     Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the~     thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent~     administration. This guidance is however, based only on consensus opinion supported by~     limited case reports (level of evidence C).~      Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP)~     MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.~   "
20141|NCT02793557|"~     A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy~     volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a~     multiple dose (MD) part.~   "
20142|NCT02793544|"~     This is a multi-center, single arm Phase II study of hematopoietic cell transplantation~     (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation~     donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil~     (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic~     malignancies.~   "
20143|NCT02793531|"~     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively~     influencing their quality of life, treatment response and survival. Weight changes in~     patients with cancer may be the consequence of energy imbalance and disturbances in protein~     metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This~     results in body composition modifications in favor of fat gain and/or lean body mass loss in~     early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass~     has been found.~      Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the~     Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein~     was able to stimulate whole-body protein anabolism equally and effectively in weight-losing~     patients with lung cancer. This indicates the high potential of proteins with high essential~     amino acids as therapeutic agents to increase muscle mass in these patients. However, the~     dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can~     differ among patients. Therefore, the Investigators would like to study the effects of~     several dosages of a protein with high essential amino acid levels, administered by sip~     feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy~     older adults. Furthermore, the individual protein requirements of cancer patients may be~     established as this is the cornerstone of nutritional support. Specifically to establish~     'the anabolic threshold', when protein breakdown equals synthesis and the response and the~     relation between protein intake and net protein synthesis are critical.~   "
20144|NCT02793518|"~     Self-defining memories (SDMs) are memories that are still important today to understand who~     the investigators are and participate to the maintain of personal identity. SDMs are also~     linked to our capacity to project ourselves into the future. In bipolar disorder, life~     events play an important role in the course and outcome of the disease. the study is the~     first to investigate SDMs and self-defining future projections in a population of remitted~     patients with bipolar disorder.~   "
20145|NCT02793505|"~     This study aims to better characterize the risk linked to metformin use during pregnancy,~     using a prospective multicentric cohort design enabling a large sample size, in evaluating~     the rate of birth defects after first trimester exposure, as well as several other pregnancy~     related outcomes.~   "
20146|NCT02793492|"~     This is a multi-center, single arm, non-randomized, prospective clinical study using the~     Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or~     occlusive lesion(s) of the common and/or external iliac artery.~   "
20147|NCT02793479|"~     The aim of this study is to establish a nationwide registry to collect data regarding the~     treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this~     registry is to increase the number of data and therefore obtain a raise of quality assurance~     and improve outcome and patient security. Furthermore to provide participating physicians~     information and experience for treatment details in the therapy of BE.~   "
20150|NCT02793440|"~     The purpose of this study is to compare the clinical outcome of medical treatment associated~     with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.~   "
20151|NCT02793427|"~     The objective of the study is to quantify the products of non-enzymatic glycation of~     proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic~     patients without clinical complications in order to define the contribution of this markers~     in the long-term monitoring of glycemic control in these patients. The results will define~     the criteria for using these new markers in daily clinical practice for the monitoring of~     these patients~   "
20152|NCT02793414|"~     This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath~     indicative of an acute malaria infection. The investigators plan to enroll 75 malaria~     patients and 175 febrile non-malaria patients in Ethiopia.~      Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a~     breath sample to assess the presence of biomarkers at a reference center. Malaria patients~     identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD~     testing will be performed concurrently to identify prevalent G6PD variants.~   "
20153|NCT02793401|"~     The investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy~     (HILT) and Ultrasound (US) treatment in chronic shoulder pain. It's a prospective,~     randomized, controlled, single blind study.141 patients were randomized into two groups, as~     HILT (n=71) and US (n=70) groups. HILT or US treatment was applied to the patients in~     addition to 14 sessions of Hotpack (Hp) + Balneotherapy + Exercise treatment. Pre-treatment~     (Pre-T), Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T~     30th day) were recorded using the visual analog scale (VAS) and shoulder pain and disability~     index (SPADI) scoring.~   "
20154|NCT02793388|"~     This is a randomized, controlled, open label trial to assess the effectiveness of~     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.~     In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is~     high. Hence patients infected with either P. vivax or P. falciparum will be included in the~     study. The study will be conducted in Ethiopia. Participants will be enrolled at health~     centres and provided with the recommended schizontocidal treatment plus primaquine radical~     cure which will be either supervised or unsupervised according to randomisation.~     Participants will be followed up for four months and assessed at regular intervals for the~     presence of patent and sub-patent malaria. The outcome of the study will contribute to an~     improved treatment scheme for uncomplicated malaria in this area.~   "
20155|NCT02793375|"~     Objective: The purpose of the present study is to evaluate the effectiveness of preoperative~     Montelukast as an analgesic for adenotonsillectomy~      Study Design: Randomized controlled double blinded clinical trial.~      Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric~     Otolaryngology, Head and Neck Surgery~      Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour~     observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized~     to receive either montelukast or placebo in Same Day surgery.~      Analysis: Differences in demographics (age, gender, race, weight) between the intervention~     and control groups will be assessed using chi-square (for categorical measures) and t tests~     (for continuous measures). Differences in postoperative opioid usage, postoperative pain~     scores using the FLACC scale, and the number of postoperative contacts (Emergency department~     visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage~     will be evaluated using chi-square (categorical measures) and t tests (continuous measures).~   "
20156|NCT02793362|"~     The purposes of this study are~        1. To explore effect of sarcopenia on recovery of post stroke hemiplegia~        2. To explore the effect of stroke on sarcopenia and relationship between the degree of~          sarcopenia and respiration and swallowing function~        3. To quantify and qualify post stroke loss of muscle mass~        4. To validity the use of echointensity and elastography in evaluation of sarcopenia.~      By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke~     complications that is closely related to worth functional outcome, thereby emphasizing the~     importance of evaluation of sarcopenia as well as its prevention.~   "
20157|NCT02793349|"~     ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a~     bioresorbable drug eluting stent in the arterial vasculature below the knee~   "
20158|NCT02793336|"~     Malaria remains an important cause of illness in young infants. Our clinical and~     epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity~     in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia,~     malnutrition and coinfection. Together these contribute significantly morbidity in early~     life, and almost certainly to the very high infant mortality rates in this region. However~     the body of knowledge around infant malaria outside of Africa, where both species P. vivax~     and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax~     malaria and severe anaemia on neurodevelopment and growth in young children is unknown in~     Papua.~      This study therefore aims to provide longitudinal data on the incidence of symptomatic and~     asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It~     also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and~     bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth~     in a vulnerable age group. The study is a continuation from two already established cohort~     studies: STOP MIP, which enrolled pregnant women and followed them until delivery and a~     baby-cohort, which enrolled babies from mothers included in the cohort and followed them~     through their first year of life. Continuous follow up of those babies until they are 4~     years old will increase our understanding of long term impact especially of vivax malaria.~     The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort~     patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic),~     allowing to estimate treatment effectiveness.~   "
20159|NCT02793323|"~     Shoulder pain is frequently mentioned in recent literature following laparoscopic~     operations. Several pain relief strategies have been proposed to decrease shoulder tip pain~     post laparoscopic surgeries. This study will be conducted to compare the Superficial~     cervical nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic~     surgeries.~   "
20160|NCT02793310|"~     The purpose of this study is to determine whether corneal transplantation by Descemet~     Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet~     Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.~   "
20161|NCT02793297|"~     The overall objective is to evaluate the impact of sourdough fermented crisp bread on~     effects on appetite and postprandial glucose and insulin responses. Beneficial effects on~     appetite and postprandial insulin responses have been observed, particularly for unfermented~     rye crisp breads in a previous study. In the present study, the investigators evaluated how~     the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well~     as a control refined wheat crisp bread product may affect self-rated appetite and~     postprandial insulin and glucose responses in healthy men and women in a meal-study. The~     investigators characterized intervention products with regards to microstructural and~     chemical features in order to elucidate underlying mechanisms for potential effects observed~     on appetite and postprandial metabolic responses.~   "
20162|NCT02793284|"~     The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL~     PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer~     recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT)~     scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and~     can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL~     PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual~     imaging [bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus~     multi-parametric magnetic resonance imaging (MRI)].~   "
20163|NCT02793271|"~     A growing number of trials have demonstrated treatment effectiveness for people with mental~     illness (PWMI) by non-specialist providers, such as primary care and community health~     workers, in low-resource settings. A barrier to scaling up these evidence-based practices is~     the limited uptake from trainings into service provision and lack of fidelity to~     evidence-based practices among non-specialists. This arises, in part, from stigma among~     non-specialists against PWMI. Therefore, interventions are needed to address attitudes among~     non-specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE~     Mental Health services (RESHAPE-mh), is an intervention for non-specialists in which social~     contact with PWMI is added to training and supervision programs. A pilot cluster randomized~     control trial will address primary objectives including trainees' perspectives on perceived~     acceptability of PWMI's participation in training and supervision, intervention fidelity and~     contagion, assessment of randomization, and feasibility and psychometric properties of~     outcome measures in a cluster design. Secondary objectives are change in provider and~     patient outcomes. The control condition is existing mental health training and supervision~     for non-specialists delivered through the Programme for Improving Mental Healthcare (PRIME),~     which includes the mental health Global Action Programme (mhGAP) and psychosocial~     treatments. The intervention condition will incorporate social contact with PWMI into~     existing PRIME training and supervision. Participants in the pilot will be the direct~     beneficiaries of training and supervision (i.e., primary care workers) and indirect~     beneficiaries (i.e., their patients). Primary care workers' outcomes include knowledge~     (mhGAP knowledge scale), explicit attitudes (mhGAP attitudes and social distance scales),~     implicit attitudes (Implicit Association Test), and clinical competence (Enhancing~     Assessment of Common Therapeutic factors, ENACT) to be assessed pre-training, post-training,~     and at 6-month follow-up. Patient outcomes include functioning, stigma experiences, and~     depression symptoms to be assessed at initiation of mental health care and 6 months later.~     The pilot study will assist in modifying the intervention to inform a larger effectiveness~     trial of RESHAPE to ultimately improve provider attitudes and clinical competence as a~     mechanism to improve patient outcomes.~   "
20164|NCT02793258|"~     Background: transcranial direct current stimulation (tDCS) is an innovative treatment for~     major depression. However, its mechanisms of action are still unclear. Major depression is~     characterized by impaired processing of emotional information, which returns back to normal~     after successful antidepressant treatment. In this randomized double-blind study, the~     investigators aim to assess the effect of tDCS on emotional processing in major depression.~   "
20165|NCT02793245|"~     The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge~     of the tracheobronchial anatomy in order to establish the best choice for the patient. The~     literature is limited regarding major bronchi dimensions. In addition, the measurement~     method is not always adequate or properly described and some publications have evaluated~     only the left bronchial diameter. Computed tomography with 3D reconstruction, technical~     reference, has been little used.~      The project is to conduct a prospective study to compare patient characteristics (age,~     height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if~     available), and dimensions of the trachea and of the main bronchi from CT scans with 3D~     reconstruction.~   "
20166|NCT02793232|"~     This study will test the safety, tolerability and blood concentrations of single and~     multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects.~     PF-06751979 is being developed for the treatment of Alzheimer's disease.~   "
20167|NCT02793219|"~     This clinical study will evaluate the role of combination therapy of Provenge followed by~     docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate~     cancer that is resistant to medical or surgical treatments that lower testosterone). The~     purpose of this study is to look at the combination therapy of Provenge followed by~     docetaxel to correlate the immunological biomarkers with clinical results for therapy.~     Biomarkers are genes, proteins and other molecules that affect how cancer cells grow,~     multiply, die and respond to other compounds in the body. The study drugs are approved by~     the Food and Drug Administration (FDA).~      Treatment will be administered on an outpatient basis. Patients will receive Provenge~     followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's~     own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists~     of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic~     (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be~     given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).~      The strategy aims to determine whether cytokine production and T cell infiltration of tumor~     cells could favor regression using a combination of vaccine plus chemotherapy. Tissue~     endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of~     therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8,~     CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be~     secondary antigen spread and various cytokine biomarkers.~   "
20178|NCT02793076|"~     The purpose of this mixed methods study is to evaluate the effects an 8-week group dance~     intervention can have on body image and posture in breast cancer survivors.~   "
20179|NCT02793063|"~     The purpose of this study is to explore the patient perspective of disease burden in~     Osteogenesis Imperfecta (OI). Participants will complete a web-based survey of questions~     which are usually administered within the Patient-Reported Outcome Measurement Information~     System (PROMIS) and provide feedback regarding the appropriateness of the questions for~     someone with OI.~   "
20180|NCT02793050|"~     This is an independent, observational, retrospective post marketing study on the use of~     trabectedin in a clinical setting.~      A data collection on the clinical use of the drug will help to improve knowledge and might~     contribute to optimize the clinical use of the drug.~   "
20181|NCT02793037|"~     Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept~     for the successful retention and outcome measures of zirconia RBBs for the replacement of~     missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival~     rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).~      The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to~     have been reported in the literature (A search pf Pub Med and Google Scholar has not shown~     any similar studies that have been published - pubmed.gov; Keywords: zirconia, resin,~     clinical assessed on 17/10/2015 AND google scholar; Keywords: zirconia, resin bonded~     fixed partial denture, resin bonded fixed dental prosthesis, Maryland, resin bonded~     bridge posterior, clinical) In addition, currently there appear to be no clinical~     trials planned or finished in this area (clinicaltrial.gov; Keywords: zirconia, resin~     assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there~     is a gap in the literature on the use of zirconia for replacing posterior teeth with such~     prostheses.~      The primary outcome measures would be: success ie. prosthesis retention ie. does not fall~     out~      The secondary outcome measures would be:~        -  complications of the prosthesis such as tipping, drifting or fracture.~        -  patient centered outcomes (satisfaction and oral health related quality of life) on the~          RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as~          current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there~          will be no difference in the patient centered outcomes.~      The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term~     follow up will be performed and this centre has experience of such long term studies (9.5~     years - Botelho 2014).~      A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as~     the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse~     2014) prosthesis were higher than 95% and this small differences would mean an unattainable~     large sample size in an equivalence test (Burns 2001).~      Significance and implications Zirconia has significant strength and greater stiffness than~     base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional~     crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to~     have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth~     replacement will offer an esthetic and biocompatible treatment option to patients over the~     traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high~     as these prostheses should be as successful (retentive).~      These results would re-write established dental prosthodontics textbooks and this would be~     the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for~     the replacement of missing posterior teeth.~      Research plan and methodology The sample pool would be obtained from patients presenting at~     the Prince Philip Dental Hospital, University of Hong Kong and who request and need~     replacement of one or more missing teeth.. They will be clinically assessed for eligibility~     and invited to participate with written consent in the study. After treatment they will be~     reviewed up to a 3rd year endpoint of the study. Further review beyond this will be~     undertaken.~   "
20168|NCT02793206|"~     Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing~     a slow, but progression loss of the visual fields. Characteristic are the crystalline~     deposits at the entrance of the optic nerve, the so called optic disc. The material consists~     of calcium, calcium phosphate, iron, but also amino acids and polysaccharides.~      The diagnose is made or confirmed by different imaging modalities like ultrasound and~     auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical~     coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and~     quantified.~      The purpose of this study whether and how defects in the visual fields are related to the~     deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional~     study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL)~     thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes~     are evaluated. The prospective trial wants to clarify whether certain parameters at baseline~     indicate the further outcome and development.~   "
20169|NCT02793193|"~     The gut-brain axis is described as being important in both, gut functions and central~     nervous system (CNS) functions. The microbiota in the gut plays an important role in this~     axis through neural, immune and endocrine systems. Previous studies have found altered gut~     microbiota (GM) composition could change the CNS functions in animals and humans. Probiotics~     were shown having positive effect on improving stress response in animals and stress related~     psychiatry in humans. The current study will investigate if probiotics can improve response~     to social stress in healthy participants and patients with irritable bowel syndrome (IBS),~     which is a stress-related disease, and whether this probiotic action can be counteracted by~     the locally acting antibiotic, Rifaximin. The investigators will use the Cyberball~     paradigram to induce social stress and magnetoencephalography (MEG) to record neural~     responses related to the social stress. The administration of the probiotics will be a new~     strategy for both the mental health management and treatment of gastrointestinal (GI)~     disorders in the future.~   "
20170|NCT02793180|"~     In the Middle East and the Gulf, the general population have high cardiovascular risks like~     diabetes, hypertension, smoking and obesity. The average age of a patient with an acute~     coronary syndrome (ACS) event is relatively young compared to Western populations. Women are~     multiparous and the rates of consanguinity marriages are high in this region of the world.~     These risk factors and conditions result in heart failure. Great deal of knowledge is~     missing regarding the influence of these risk factors on heart failure presentation, the~     causes and management of heart failure in ambulatory patients in this region of the world.~   "
20171|NCT02793167|"~     Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant~     mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of~     AKI by early detection and timely referral to the renal,the investigators developed an~     electronic alert system which identifies all cases of AKI occurring in patients over 18~     years.The system was also designed to collect data on AKI incidence one of the biggest~     tertiary hospital in China.~   "
20172|NCT02793154|"~     The primary objective of this study is to compare the effect of albiglutide and exenatide on~     gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by~     visual analogue scale [VAS]) in subjects with type 2 diabetes mellitus (T2DM). The study is~     divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide~     and confirm exenatide as a positive control for Part B. Part B will compare the effects of~     albiglutide and exenatide on GMA, GE and nausea.~      Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg)~     subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a~     3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose~     of exenatide). The total duration of a subject's participation in Part A will be~     approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to~     progress to Part B will be made.~      In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of~     30 milligrams [mg] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or~     exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily~     for 4 weeks). The total duration of a subject's participation in the study will be~     approximately 15 weeks.~   "
20173|NCT02793141|"~     The International study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE) is a~     prospective, international, multicentre, observational, cohort study. The study aims to~     provide up-to-date and generalisable information on current worldwide epidemiology and~     clinical practice associated with diagnosis and management of nosocomial pneumonia in~     Intensive Care Unit (ICU) patients.~      PneumoINSPIRE study is endorsed by the European Society of Intensive Care Medicine (ESICM).~   "
20174|NCT02793128|"~     The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial~     carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective~     this will lead to the development of a new treatment approach for patients suffering from~     Low Grade Upper Urinary Urothelial Carcinoma (UTUC).~   "
20175|NCT02793115|"~     This study seeks to ascertain the best way to inform patients about their physicians'~     conflicts of interest (COI) with industry. Currently, there is no institutional or national~     standard for such physician-to-patient disclosures. The primary aim of this study is to test~     different written disclosures and assess their impact on patients' knowledge of their~     physicians' COIs and on patients' trust in their physician and their healthcare institution.~     The secondary aim is to investigate whether physician disclosures of significant financial~     industry relationships are desired by patients and whether disclosures impact patients'~     knowledge, perceptions, and behaviors. The tertiary aim is to investigate physicians'~     current practices of disclosure and perceptions about the risks, benefits, and feasibility~     of using patient disclosures to manage financial relationships, and to determine whether any~     physician fears are borne out in practice once disclosures are implemented.~   "
20176|NCT02793102|"~     In the literature the use of olfactory dimension in the treatment of anorexia has not been~     verified experimentally. The investigator hypothesize that the therapeutic use of a dietary~     nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a~     prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as~     the primary endpoint of the state of anorexia nervosa patients.~   "
20177|NCT02793089|"~     This study evaluates the increased risk of ectopic pregnancy associated with marked~     variation of estradiol during the early luteal phase and high progesterone on hCG day in~     IVF.~   "
20182|NCT02793024|"~     The objective of this project is to develop and test the effectiveness of a Cooperative~     Extension enhanced intervention titled Smart Shopping, aimed at improving the shopping~     practices of adolescents with the ultimate goal of increasing fruit and vegetable intake. To~     achieve this goal, the investigators will conduct formative research (Year 1) via a~     community-wide analysis of the school, home and neighborhood food environments. In~     collaboration with Extension staff and faculty, this formative research will provide insight~     into the development and enhancement of the Smart Shopping curriculum (adapted from the~     Cooking Matters Extension curriculum, Year 2). In Years 3-4, the investigators will~     implement a randomized controlled intervention trial to examine the effectiveness of the~     developed intervention Smart Shopping to improve adolescents' purchasing and consumption~     behaviors. The investigators will implement the trial in Year 3, and evaluate results in~     Year 4. Our education component will include training of University dietetics interns,~     graduate, and undergraduate students to implement and evaluate the intervention with~     oversight by project staff as part of their service learning requirements. This project is~     unique as it: 1) takes into account the role that school wellness policies and school~     environment have in food procurement during the day; 2) incorporates information from~     multiple levels of the social ecological framework (home, school, and community food~     environments, as well as the social influence of peers) to create an intervention that~     addresses influences on adolescents purchasing and consumption behaviors where they live and~     learn; 3) collaborates with Extension faculty and staff while enhancing an existing program;~     4) utilizes and hones the skill sets of students in undergraduate and graduate level~     nutrition and dietetics programs.~   "
20183|NCT02793011|"~     The investigators will use a prospective randomized, controlled design utilizing a single~     preoperative dose of oral dexamethasone or placebo to achieve these specific aims:~        -  Specific Aim 1: To evaluate the potential for a single preoperative dose of oral~          dexamethasone administered the night before surgery to reduce the incidence and~          severity of early post tonsillectomy pain (PTP) in children~        -  Specific Aim 2: To prospectively evaluate differences in early PTP experience between~          overweight/obese children and their lean peers.~        -  Specific Aim 3: To determine whether circulating inflammatory markers are strongly~          linked to PTP severity in children and whether they could be potential contributors to~          the higher pain experienced by overweight/obese children following Tonsillectomy and or~          Adenoidectomy.~   "
20184|NCT02792998|"~     The objectives of this study are:~      Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and~     pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to~     healthy subjects over 7 days of repeated dosing~      Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets~     administered orally to healthy subjects, in fed and fasted states, in an open-label,~     single-dose, 2-period, 2-sequence crossover study.~   "
20185|NCT02792985|"~     The objective of this Phase II trial is to evaluate the feasibility of this study protocol~     to progress to a large-scale Phase III RCT in the future. It will also determine, with~     limited efficacy, the effectiveness of the multisensory stimulation intervention protocol to~     reduce the duration of post-traumatic amnesia (PTA), improve cognition, increase~     independence in activities of daily living and long term quality of life of the affected~     person.~      Participants will be randomised into either the experimental or control group. The~     experimental group will follow the multisensory stimulation intervention protocol, while the~     control group will follow the current hospital protocol.~   "
20186|NCT02792972|"~     Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose~     should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern~     region of the country and popularly known as jambu, has aroused the interest of researchers~     because of its therapeutic potential. Objective: To evaluate the potential topical analgesic~     and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture~     procedures. Methods: This is a clinical, randomized, controlled trial with healthy~     volunteers recruited at the Clinic I of the collection of biological materials sector of the~     Hospital das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea~     manipulated with Transcutol® and 70% alcohol were used in the volunteers before the~     venipuncture procedure as allocation in study groups. Held collection of skin microbiota by~     the swab technique and the end of the venipuncture procedure was applied to the volunteer,~     the visual numeric scale (VNS) standard to determine the degree of pain.~   "
20187|NCT02792959|"~     This study evaluates the therapeutic response by modern FMRI and PET techniques with the~     perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize~     the respective performances and to define the early assessment criteria, at the first detox,~     of the treatment efficacy, with and without antiangiogenic agent.~   "
20188|NCT02792946|"~     Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients~     with acute bronchitis~   "
20189|NCT02792933|"~     Epidural space localization using loss of resistance technique with air (ALOR) is~     controversial in obstetric analgesia due to a minor efficacy and risk of complications,~     compared with loss of resistance technique with saline (SLOR). This randomized prospective~     study will compare the efficacy and incidence of most common complications of both~     techniques in obstetric analgesia.~   "
20190|NCT02792920|"~     To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in~     patients with ST-elevation acute myocardial infarction, as well as identify the~     characteristics and efficacy of CoCr-EES.~      Also, OCT sub-analysis will be conducted~   "
20191|NCT02792907|"~     Compressive stockings ameliorate functional outcome and quality of life in patients after~     elective orthopedic foot and ankle surgery. In this randomized controlled trial the~     investigators want to analyze the effect of compressive stockings after foot and ankle~     surgery. Additionally the investigators want to evaluate the compliance of the compressive~     stockings Treatment. Therefore an electronic chip device is implanted into the compressive~     stockings to monitor wearing time.~   "
20209|NCT02792673|"~     The study design is a prospective randomized uncontrolled clinical trial. It will include~     150 cases.~      The aim of this study is to compare the efficacy of three different media used for embryo~     transfer regarding chemical and clinical pregnancy rate, implantation rate and ongoing~     pregnancy and miscarriage rates in IVF and ICSI cycles.~      The three different embryo transfer media are:~        1. Hyaluronan-enriched medium Embryo Glue®~        2. 30% Protein-supplemented Culture medium Global Total®~        3. Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media~          for embryo transfer~   "
20210|NCT02792660|"~     This is clinical feasibility study on the device performance with paediatric patients. The~     main objective is to validate the performance of investigational device in distinguishing~     and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar~     puncture on paediatric patients.~   "
20192|NCT02792894|"~     Over 6% of children in Pakistan suffer from a developmental disorder (intellectual~     disability or Autistic spectrum disorder) and most receive no intervention.In an earlier~     proof of concept study, the investigators integrated social, technological and business~     innovations to develop and successfully pilot a sustainable service for such children in one~     rural population of 30,000. Affected families were identified through a mobile phone-based~     interactive voice response system, and organised into family networks. 'Champion' family~     volunteers were trained in evidence-based interventions. A Tablet-based android application~     was developed for training, monitoring and supervision of the champions, based on the World~     Health Organization's guidelines. The champions delivered the intervention to other families~     in the network. The project was sustainable and demonstrated significant improvements in the~     lives of children and their families in the first 6 months of its operation. The~     investigators are scaling-up this intervention to a population of 1 million. The~     investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up~     programme using cluster randomized control trial nested within the scale-up study.~   "
20193|NCT02792881|"~     The purpose of this study is to explore the safety, feasibility, long-term and oncological~     outcomes of laparoscopic total gastrectomy for remnant gastric cancer.~   "
20194|NCT02792868|"~     Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83~     patients), with normal, non-diabetic renal function. The investigators quantify the~     phophocalcic intake and excretion, realizing a food examination and a urine collection of 24~     particular. The investigators will measure plasma levels of FGF23 serum calcium,~     phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The~     investigators will conduct a quantitative assessment of coronary calcification by a~     non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an~     analysis of collinearity. An adjustment will be made for confounding variables in a~     generalized linear regression model.~   "
20195|NCT02792855|"~     The simple head extension is recommended for optimization of glottic visualization during~     awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date~     has conﬁrmed its superiority over snifﬁng position . In a prospective, randomized study,~     the authors compared the snifﬁng position with simple head extension in awake orotracheal~     Intubation~   "
20196|NCT02792842|"~     The purpose of this study is to evaluate the efficacy and safety of ART-123 for the~     prevention of cancer treatment related symptoms in patients with postoperative stage II /~     III colon cancer.~   "
20197|NCT02792829|"~     The study will be conducted in adult healthy participants and will consist of two phases:~     Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a~     Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods~     (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT)~     Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3~     consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block~     design with 2 factors [number of capsules and whether water or apple juice is used as~     vehicle]). Each participant will be randomized into one of 8 sequences.~   "
20198|NCT02792816|"~     Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum~     malaria patients in Myanmar and artemisinin molecular markers analysis~   "
20199|NCT02792803|"~     The purpose of the study is to provide evidence that the efficacy of Xalatan will be~     superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in~     patients with primary open angle glaucoma. The study will also aim to prove the tolerability~     of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.~   "
20200|NCT02792790|"~     The investigators will prospectively evaluate tissue samples obtained from patients~     undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed.~     Patients who have tissue that stains positive for amyloid will undergo cardiac testing to~     look for evidence of cardiac involvement.~   "
20201|NCT02792777|"~     The goal of this study is to improve the methods with which researchers identify patient~     centered outcomes for use in research. Specifically, the investigators will test the~     application of concept mapping as compared to one-on-one interviews as a comprehensive and~     efficient method of identifying patient-important outcomes for use in research.~   "
20202|NCT02792764|"~     This study is to collect current information on complications rates of subjects undergoing~     chemotherapy administration through Ports and peripheral IVs.~   "
20203|NCT02792751|"~     Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving~     cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or~     general anesthesia. The investigators primary outcome was to evaluate the effects of the~     depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation~     during the ERCP procedure by analyzing the biochemical parameters. And their secondary~     outcome was the effects of anesthesia depth on propofol consumption and postoperative~     sedation status.~   "
20204|NCT02792738|"~     The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.~   "
20205|NCT02792725|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the expanded access program.~   "
20206|NCT02792712|"~     Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg~     vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic~     resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.~   "
20207|NCT02792699|"~     This trial is designed to determine what effects the human body has on the investigational~     medicine, ABP 798, and what effects the body has on the investigational medicine after you~     have been given it, and if this is comparable to what is seen for the licensed medicine,~     rituximab, in patients with moderate or severe RA.~      This study will assess if the investigational medicine is safe and effective in treating~     moderate or severe RA compared to the licensed medicine.~   "
20208|NCT02792686|"~     This study is an open label, parallel group, single ascending dose, exploratory study~     performed in a single site (Centre Cap, Montpellier, France).~   "
20211|NCT02792647|"~     The purpose of this study is to investigate the safety and tolerability of IX-01 after~     multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.~   "
20212|NCT02792634|"~     Obesity and obesity related health problems are globally recognized as one of the major~     threats to public health. Bariatric surgery is the most effective and durable therapy option~     for obesity and the improvement of obesity related co-morbidities. Non alcoholic~     steatohepatitis (NASH) is an important comorbidity of obesity and improves after surgical~     intervention. In this study investigators try to enlighten the weight independent mechanism~     for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure~     will be observed for at least 24 month. A liver and adipose tissue samples are gained during~     the operation. Liver function and morphology are observed before and after operation with~     LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before~     and after surgical intervention. In order to check the microbiome stool samples are~     collected throughout the entire observation period.~   "
20213|NCT02792621|"~     As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced~     mobility and quality of life. To understand and reverse this negative process investigators~     need to find new ways of improving the ability of muscle to perform physical activity. There~     is some evidence that supplements may improve how the mitochondria work, and investigators~     want to explore this idea in more detail, by measuring how the muscles work and respond to~     exercise before and after taking the supplement. This will give us the basic information~     investigators would need to see if this is a useful idea.~   "
20214|NCT02792608|"~     Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and~     psychosocial sequelae. Unfortunately, to-date there has been very limited research into~     rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone,~     access to effective, evidence-based rehabilitative treatment that would improve BT~     survivors' quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based~     Interventions (MBIs) are emerging as a potential treatment to address this need. MBIs are~     group-based psychological treatments for coping with illness or disability, with the goal of~     improving psychological wellbeing. Recent studies have begun to suggest a role for MBIs in~     addressing symptom burden and QOL in the acquired brain injury (ABI) population, a~     heterogeneous population that includes survivors of stroke and traumatic brain injury, as~     well as BT survivors. High quality research, including rigorous randomized controlled~     trials, are needed to demonstrate whether MBIs can provide efficacious, accessible and~     cost-effective treatment to improve the lives of BT survivors.~   "
20215|NCT02792595|"~     The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo~     on the back of human participants, according to the International Standard Sun Protection~     Test method by using a sun simulator.~   "
20216|NCT02792582|"~     Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in~     a region of the brain near the pituitary gland, visual pathways, and central blood vessels.~     Patients often present with headache, loss of vision or delayed growth. In some instances~     they may present with imbalance of water and salts in the body.~      The treatment for craniopharyngioma may be radical surgery or a combination of surgery and~     radiation therapy. In some instances surgery is not required. If the tumor cannot be~     completely removed, radiation therapy may be required. In this study we will use the most~     advanced form of proton therapy which is called intensity-modulated proton therapy. This is~     a newer form of radiation therapy which has a number of advantages over older forms of~     proton therapy and conventional radiation therapy using x-rays.~      The main goal of this study is to learn if proton therapy will effectively treat patients~     with craniopharyngioma brain tumors and reduce side effects compared to more traditional~     forms of radiation therapy.~   "
20217|NCT02792569|"~     The aim of this project is to activate recruitment and growth of resting primordial~     follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase~     the chance to become pregnant, either naturally or after assisted reproduction.~   "
20218|NCT02792556|"~     According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et~     des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing~     number.~      The success rate of drug abortion before 49 days of amenorrhea, defined by the National~     Health Autority as a complete abortion not requiring surgery, varies from 92 to 98%~     depending on the pregnancy term and the dose used.~      The control visit is performed between the 14th day and the 21th day post abortion. Its role~     is to monitor the effectiveness of the method, to verify absence of complication and to~     better adapt contraception to prevent another unwanted pregnancy. The choice of the method~     is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.~      In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method~     performed during the control visit is transvaginal ultrasound.~      To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive~     alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and~     low cost.~      The main objective of this study is to evaluate the diagnostic value of urine pregnancy test~     CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion~     during the control visit.~      This is a monocentric observational study.~   "
20219|NCT02792543|"~     In the case of intestinal failure with a high-output double enterostomy, the parenteral~     nutrition (PN) is the gold standard treatment until the surgical reestablishment of~     digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks~     of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR)~     is an enteral nutritional technique which reestablishes the functional continuity of the~     anatomically present small bowel through an extracorporeal circulation of the chyme. In~     patients with intestinal failure with a temporary high-output double enterostomy, we~     hypothesize that CR, compared to PN will reduce post-operative complications after surgical~     reestablishment of digestive continuity, maintain the intestinal function including~     absorption, and reduce the complications during the transitional period pending the surgical~     reestablishment of digestive continuity.~   "
20220|NCT02792530|"~     This study will evaluate the efficiency of dietary intervention on intradialytic weight~     gain. Uniric hemodialysis patients without serious dietary complications, who accumulate~     above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary~     consultations for sodium restriction. One month after the intervention, their intradialytic~     weight accumulation will be measured.~   "
20221|NCT02792517|"~     A pharmacokinetic drug interaction study of AMG 334 and an oral contraceptive containing~     progestin and estrogen.~   "
20226|NCT02792452|"~     The management of symptomatic patients with moderate Aortic Stenosis (AS) remains~     challenging and tests that would give more definitive answers are needed. The value of~     increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and~     calculation of valve compliance/resistance during stress echo (SE) in the symptomatic~     moderate AS population prognostication has to the investigators knowledge not been examined~     before. Similarly the additive value of myocardial blood flow reserve (MBFR), Computed~     Tomography (CT) calcium score, speckle tracking echocardiography, carotid ultrasonography,~     and N-Terminal pro B- type natriuretic peptide B (NT-proBNP) in the prognostication of this~     population group especially in combination with SE remains unclear.~   "
20227|NCT02792439|"~     America Walks is an observational research study to determine walking behavior of~     individuals in the United States. The entire study will be conducted virtually by requiring~     participants to download a mobile phone application (App), The App will leverage the mobile~     phone's step count sensor technology to automatically determine participants' daily walking~     activity. Participation is voluntary. Participants can choose not to participate or choose~     to participate and then stop participating. Participants decision will not result in any~     penalty or loss of benefits to which they are entitled.~   "
20228|NCT02792426|"~     To better understand the PK and associated pharmacodynamic (PD) responses produced by the~     Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to~        -  The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved~          smoking cessation product, the NICOTROL Inhaler, in current non-menthol cigarette~          smokers who have some limited e-cigarette experience (Group 1).~        -  Commercially available products in current primarily e-cigarette users (experienced~          ENDS users) (Group 2) The PK/PD session for each product will be conducted in a~          controlled clinical setting with frequent PK sampling after 14 hours of supervised~          abstinence from all forms of nicotine. Subjects will familiarize themselves with the~          Research ENDS S-TA-U001 and NICOTROL Inhaler by using each product in the real world~          for one day before the PK/PD session for that product.~      Primary Objectives:~      Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma~     concentration [Cmax], time to maximum plasma concentration [Tmax], area under the~     concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib~     sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level~     during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK~     profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured~     at the baseline session, and to demonstrate superiority of PK profile of Research ENDS~     S-TA-U001 to that of the marketed NICOTROL Inhaler.~      Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001~     and explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation~     and 6 hour ad lib use sessions, and to compare the PK profile between Research ENDS~     S-TA-U001 to the profile of a commercial ENDS product measured at the baseline session.~      Secondary objectives:~      Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to~     the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS~     for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to~     evaluate the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a~     combustion cigarette or the NICOTROL Inhaler (Group 1) or a commercial ENDS product (Group~     2), and to evaluate various biomarkers following use of each test product.~   "
20229|NCT02792413|"~     Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease~     females the effect of denosumab:~        -  on bone mineral density (femoral T-score) at 24 months~        -  on bone mineral density evolution (femoral T-score) after 24 months of follow-up~        -  on bone mineral density evolution (lumbar T-score) after 24 months of follow-up~        -  on coronary and abdominal aorta calcification scores evolution after 24 months of~          follow-up~        -  on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and~          calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone~          alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of~          follow-up~        -  on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of~          follow-up~        -  the tolerance after 24 months of follow-up~   "
20230|NCT02792400|"~     In normal physiology, glucagon from pancreatic alpha cells plays an important role in~     maintaining glucose homeostasis via its regulatory effect on hepatic glucose production.~     Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state,~     and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations~     fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may~     therefore contribute importantly to the hyperglycaemia of the patients.~      Several glucose-lowering treatment modalities have been shown to affect glucagon levels in~     patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of~     these treatment modalities has been difficult to discern. By using a glucagon receptor~     antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate~     the role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2)~     inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase~     and decrease plasma glucagon levels, respectively.~   "
20231|NCT02792387|"~     The aim of the study is to explore association between increased central venous pressure,~     Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type~     1 and 2. The pilot study was set to provide the expected correlation coefficient for a~     sample size determination of the subsequent study.~   "
20232|NCT02792374|"~     The objective of this descriptive investigation was to evaluate the psychological profile of~     dental patients in three levels: global level, the dimensional level, and the discrete~     symptom level and to compare it with a control group.~   "
20233|NCT02792361|"~     This is a clinical trial where patients who present to the neurosurgery service in need of a~     procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled~     for the randomization in the placement of a drain at the surgical site. At present, there is~     not a protocol for whether or not to use a drain following this procedure. There is some~     debate on whether it serves any real benefit for the patient or if it may actually be~     detrimental in cases where infection occurs. This study aims to answer this question by~     randomizing patients to drain placement and then comparing patient outcomes between the two~     groups. These include the following: infection rate, length of hospital stay, self-reported~     patient pain and discomfort, the amount of time before patients are able to open their eye~     ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and~     any unforeseen post-operative complications. This will be accomplished through using a~     patient-administered survey, recording physical measurements, and a patient chart review.~     Statistical analysis will then be used to identify any differences that may exist.~   "
20259|NCT02792010|"~     Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage~     modifications could provide better patient treatment. The T1rho MRI sequence allows the~     quantification of the cartilage signal that is correlated to modifications of the cartilage~     matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of~     hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the~     measurements. T1rho and T2 mapping sequences were acquired twice during the same session~     with 30 minutes interval to see if values were modified after a 30 minutes delay in a supine~     position. The secondary objective was to assess the correlation between T1rho and T2 values.~   "
20234|NCT02792348|"~     For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are~     difficult to confirm only with morphological examination (ultrasonography, intravenous~     pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time~     allows the post confirmation of a significant UFI requiring a surgery. This meant that the~     actual therapeutic indications are imperfect by the absence of an absolute endpoint for~     UFI.~      The objective of the study is to characterize the urinary metabolomics profile of new born~     with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction~     anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal~     ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This~     characterization will allow the identification of statistically significant metabolomics~     markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The~     evolution with time of these metabolomics profiles will also considered.~   "
20235|NCT02792335|"~     To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF)~     patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).~   "
20236|NCT02792322|"~     This study is designed to investigate if transoral surgery with the patient in the seated~     position utilizing the da Vinci&#174; Robotic Surgical System (Intuitive Surgical, Inc.,~     Sunnyvale, CA) will enable better visualization and expedited removal of benign and~     malignant tumors of the throat.~   "
20237|NCT02792309|"~     Mathematica was awarded a contract by ACF to conduct the evaluation of selected grantees~     offering Healthy Marriage and Relationship Education Programs.This particular evaluation~     will focus on the University of Denver's MotherWise program, which offers relationship~     education and other supports to low-income women expecting a baby. The program has three~     core components: (1) 18 hours of core workshop sessions using the Within My Reach~     relationship education curriculum supplemented with content on mother-infant relationships;~     (2) case management services; and (3) optional relationship education workshops for couples.~     The evaluation will test the effect of this full package of services on mothers'~     relationship outcomes, as well as other outcomes related to child well-being, such as~     co-parenting and father involvement.~   "
20238|NCT02792296|"~     This is an open-label study in adults to assess at-home Project: EVO Monitor measurements~     over repeat play cycles. The study has three arms:playing multiple times per day, once~     daily, and once weekly for 4 to 8 weeks.~   "
20239|NCT02792283|"~     The objective is to evaluate the function of the platelet in patients undergoing~     hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood~     assay with three pathways of platelet activation to describe a platelet response profile.~      The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that~     may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to~     anticoagulate the hemodialyzer, on platelet function will be assessed.~   "
20240|NCT02792270|"~     This study is being conducted to decrease the rate of surgical wound complications. The~     investigators are studying the effects that caloric restriction has on decreasing the rate~     of surgical wound complications.~   "
20241|NCT02792257|"~     Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging.~     Neuropsychiatric symptoms (NPS) in AD are a major cause of burden to patients, caregivers,~     and society and are near-universal at some point in the AD course. One of the most troubling~     of these symptoms is agitation (Agit-AD), typified by a variety of problem behaviors~     including combativeness, yelling, pacing, lack of cooperation with care, insomnia, and~     restlessness There is a great need for better interventions that target Agit-AD, a major~     source of patient disability as well as caregiver burden and stress, particularly in the~     case of moderate to severe agitation. This pilot trial could open the door to repurposing~     Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public~     health impact.~   "
20242|NCT02792244|"~     Previous studies show that incontinence is relatively common during pregnancy and after~     delivery. Experiencing incontinence during pregnancy or in the first year after delivery~     increases the risk of long term incontinence. There is scarce documentation of the long term~     prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and~     risk factors for incontinence approximately six years after delivery among the 1718 who~     participated in two previous studies exploring the prevalence and predictors of anal~     incontinence in late pregnancy and during the first year after first delivery, and the~     effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery.~     Increased awareness and knowledge about risk factors and long term prevalence of anal~     incontinence among health professionals as well as pregnant and parous women may give~     indications about which women to target for preventative measures to reduce the risk of new~     onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may~     aid in planning individualized follow-up during pregnancy and the first year as well as in~     the long term among women with existing AI symptoms.~   "
20243|NCT02792231|"~     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4~     weeks versus teriflunomide administered orally once daily in patients with relapsing~     multiple sclerosis~   "
20244|NCT02792218|"~     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4~     weeks versus teriflunomide administered orally once daily in patients with relapsing~     multiple sclerosis~   "
20260|NCT02791997|"~     The project studies auditory processing after brain damage (in temporal and/or frontal~     areas) and in migraine. The auditory processes investigated are attention, short-term~     memory, sound-induced emotions. To characterize auditory deficits after brain damage or in~     migraine, neuropsychological assessments are combined with neurophysiological markers~     (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:~     MRI).~   "
20261|NCT02791984|"~     Respiratory changes in aortic blood velocity have been described as an indicator of fluid~     responsiveness when measured in the left ventricular outflow tract by trans esophageal~     echography. A threshold value of 12% allowed discrimination between responders and~     nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window~     is already used to measure cardiac output. The primary endpoint of this study is to~     determine the predictive value of the respiratory variability in aortic blood velocity~     measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The~     secondary endpoint is to compare maximum velocity and velocity time integral measured by~     suprasternal and transthoracic view.~   "
20245|NCT02792205|"~     Von Willebrand Disease (VWD) is defined as an inherited bleeding disorder that is caused by~     deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates the~     initial adhesion of platelets at sites of vascular injury and also binds and stabilizes~     blood clotting factor VIII (FVIII) in the circulation. The most severe forms of VWD are~     usually easy to diagnose (obvious hemorrhagic symptoms and major VWF deficiency), whereas~     the mild forms of the disease are still difficult to confirm. It is indeed reported that~     about 1% of the population carry mild biological VWF deficiency without any bleeding~     tendency and any actual disease. On the contrary, some patients with severe bleeding~     history can carry a true VWF abnormality, well-confirmed by genetic studies, without any VWF~     deficiency when evaluated with standard biological methods, such as Ristocetin Cofactor~     activity (VWF:RCo). However, in these patients, the use of alternative methods, such as~     PFA-100 (Platelet Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF~     (FVIII:C/VWF) ratio or the evaluation of VWF activity using more specialized methods such as~     VWF:CB (VWF-Collagen Binding) assay can detect the VWF deficiency and possible hemorrhagic~     predisposition.~      In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis~     of VWF deficiency in patients with unexplained bleeding history.~   "
20246|NCT02792192|"~     This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics,~     immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of~     atezolizumab administered by intravenous (IV) infusion alone or in combination with~     intravesical BCG in high-risk NMIBC participants.~   "
20247|NCT02792179|"~     This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who~     previously participated in study BP29409 (NCT02187627). This study is designed to assess the~     longitudinal change of Tau pathology in the brain of participants with AD using the PET~     ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.~   "
20248|NCT02792166|"~     The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three~     decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities~     such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main~     categories: a) those that cause restriction, and b) those that add a malabsorptive component~     to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation,~     is the most frequently performed procedure in North America.~      Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric~     bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective~     procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS~     procedure has been shown to be significantly more effective than RYGB in achieving durable~     weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes,~     the performance of BPD-DS is highly institution dependant and comprises less than 5% of the~     annual bariatric procedures performed worldwide.~      Common reservations against BPD-DS are related to the side effects of the procedure, and~     include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition.~     Furthermore, longer operative times and surgical technical challenges are also reasons for~     lower prevalence of the BPD-DS procedure.~      Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification~     of the conventional BPD-DS that potentially addresses many of these concerns. In addition,~     it is a suitable second-stage or salvage procedure for severely obese patients with~     inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite~     showing excellent results of up to 5 years with acceptable postoperative morbidity, all the~     literature on SADI-S originates from a single center and has not been compared directly with~     BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative~     outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.~      This project has three specific aims:~        1. To evaluate feasibility and short-term safety of SADI-S.~        2. To evaluate short and long-term beneficial outcomes.~        3. To evaluate and compare long-term morbidity.~   "
20249|NCT02792153|"~     The purpose of this study is to determine whether estrogen may help reduce fear of high~     calorie-density foods in weight-restored women with Anorexia Nervosa (AN).~   "
20250|NCT02792140|"~     In this study, the investigators pose the question which influence the opioid circuit has on~     positive valent situations in dreams.~   "
20251|NCT02792127|"~     The purpose of this study is to investigate the efficacy of an online program in reducing~     symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative~     evaluations and improving quality of life in students with above-average social anxiety.~   "
20252|NCT02792114|"~     The purpose of this study is to test the safety of different doses of specially prepared T~     cells collected from the blood. The investigators want to find a safe dose of these modified~     T cells for patients who have metastatic HER2-negative breast cancer.~   "
20253|NCT02792088|"~     To prove that a study drug is noninferior to a control drug with a proportion of subjects~     who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after~     48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic~     hepatitis B patients~   "
20254|NCT02792075|"~     The purpose of this study is to evaluate the prognosis of coronary stenosis based on~     intracoronary Imaging.~   "
20255|NCT02792062|"~     The purpose of this study is to evaluate food effects on the pharmacokinetics of a single~     oral dose of TAK-385 in Japanese premenopausal healthy adult women.~   "
20256|NCT02792049|"~     Investigators compared tidal volumes for single rescuer ventilation using a modified bag~     valve mask with an integrated internal handle versus a conventional bag valve mask in a~     manikin model.~   "
20257|NCT02792036|"~     Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or~     refractory disease following therapy most often occurs due to persistence of vitreous~     disease and/or retinal reactivation of the main tumor mass. With this treatment protocol,~     investigators seek to identify a less invasive method of local drug delivery that does not~     disrupt the eye's integrity.~      PRIMARY OBJECTIVE:~        -  To determine the safety and toxicity profile associated with intravitreal carboplatin~          for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous~          seeding.~      SECONDARY OBJECTIVES:~        -  To estimate the ocular salvage rate after treatment with intravitreal carboplatin in~          patients with recurrent or progressive intraocular retinoblastoma with vitreous~          seeding.~        -  To evaluate the effects of intravitreal carboplatin therapy on the histopathology of~          eyes enucleated for progressive or recalcitrant disease while on therapy.~   "
20258|NCT02792023|"~     Prospective study to test whether the immunochemical fecal occult blood test (FIT) for~     colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for~     colonoscopy.~   "
20307|NCT02791386|"~     The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide~     analogue (NA) resistance and assess the real-world treatment outcomes and health resources~     utilization of rescue treatments for drug resistance in a clinical cohort of Chinese~     patients with chronic hepatitis B (CHB).~   "
20262|NCT02791971|"~     The purpose of this study is to determine whether delivery of SpeakOut, a behavioral~     intervention to increase social communication about long-acting reversible contraceptive~     (LARC) methods among adolescents, is associated with increased uptake of LARC methods among~     the social contacts of SpeakOut recipients.~      The investigators will conduct a cluster randomized controlled trial of SpeakOut with~     adolescent LARC users and their female peers. Over three years, SpeakOut will be implemented~     in eight partner clinics. IUD and implant users aged 15 to 19 who attend appointments at~     participating clinics will be invited to enroll in the evaluation study as primary~     participants and receive either SpeakOut or a control intervention about alcohol use. The~     social contacts of primary participants will be asked to enroll in the study as secondary~     participants. The study's primary outcome will be the proportion of sexually-active~     secondary participants who initiate use of a LARC method within 9 months of study~     enrollment.~   "
20263|NCT02791958|"~     This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR~     (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective~     reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.~   "
20264|NCT02791945|"~     The goal of the project is to improve the care of Veterans with mild traumatic brain injury~     (mTBI) and unhealthy alcohol use.~   "
20265|NCT02791932|"~     Fifteen percent of women experience depression during pregnancy or postpartum (i.e.,~     perinatal depression). Furthermore, 38% of low income women experience postpartum~     depression. Given few women with perinatal depression seek treatment, there is a need for~     innovative, low cost interventions that can be integrated within existing community-based~     programs serving women in need (e.g., low income women). The primary aim of this study is to~     examine the efficacy of a novel exercise intervention designed to prevent perinatal~     depression among women attending federally qualified health centers serving high risk women.~   "
20266|NCT02791919|"~     This phase I trial studies the side effects and best dose of wee1 kinase inhibitor AZD1775~     when given together with fludarabine, cytarabine, and filgrastim (FLAG) combination~     chemotherapy in treating children, adolescents and young adults with relapsed or refractory~     acute myeloid leukemia. Wee1 kinase inhibitor AZD1775 may help combination chemotherapy work~     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such~     as fludarabine and cytarabine, may prevent tumor cells from multiplying by damaging their~     deoxyribonucleic acid (DNA), which in turn stops the tumor from growing. Giving wee1 kinase~     inhibitor AZD1775 and FLAG chemotherapy may work better in treating patients with acute~     myeloid leukemia.~   "
20267|NCT02791906|"~     Heart failure (HF) is an epidemic and is a major burden on the US healthcare system. The~     most common cardiovascular endpoint is HF. Thus, novel interventions to prevent HF in CKD~     are highly desirable. This study will assess: the variability in the response to ISMN~     therapy; the degree of change in central hemodynamics and cardiac endpoints through analysis~     of changes in LV mass, diffuse myocardial fibrosis, and myocardial systolic and diastolic~     function.~   "
20268|NCT02791893|"~     The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by~     a problem with widespread pain. Besides their pain, the researchers will also assess the~     effect of vagus nerve stimulation (VNS) in alleviating migraine headache, another complaint~     of Gulf veterans, which is common in the presence of widespread pain. Importantly, the~     researchers are partnering with a company that has made a hand-held device that allows for~     stimulation of the vagus nerve without the need for surgery; it works by the patient putting~     it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second~     periods three times a day. The device is programmed to deliver only 6 bouts of stimulation~     per day - one to each side of the neck three times a day; it is then inactive until the next~     day. The fact that this device can be used without surgery and is non-invasive makes it~     extremely practical for use.~      After collecting pre-treatment measurement of pain severity and headache severity, veterans~     will receive either the actual active VNS device or an inactive device, which does not~     stimulate the nerve. Veterans will use their device for ten weeks - providing similar~     information periodically over this period by responding to questions about the severity of~     their pain and headaches, They will then return to the Center for the final phase of the~     study where all veterans will receive active devices. Ten weeks later, they will return to~     the Center to provide information to allow the investigators to gain further knowledge as to~     the effectiveness of actual VNS in relieving pain - both throughout the body and in the~     head.~   "
20269|NCT02791880|"~     In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly~     utilized alternative procedure for replacing a stenotic aortic valve. This study collects~     clinical information, DNA, blood and urine samples (throughout procedural hospitalization)~     in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing~     TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to~     identify blood and urine biomarkers that can be used for early detection of AKI around the~     time of the procedure. The study seeks to assess for novel genetic variants associated with~     development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants~     and biomarkers that are associated with adverse cardiovascular events after TAVR and to~     further explore how these events may inter-relate with acute kidney injury.~   "
20270|NCT02791867|"~     The primary objective is to determine if subjects taking the natural product AphoelineBrake™~     in addition to their standard treatment experience differences in metabolic disease control,~     gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared~     to patients taking a placebo in addition to their standard treatment. The secondary~     objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress~     markers.~   "
20271|NCT02791854|"~     Innovative programs exist that suggest that care for people with chronic conditions is~     optimized when patients and providers have the information they need at the point of care~     and over time, to engage in shared planning and execution of treatment goals and care plans.~     This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared~     information environment, that highlights collaboration among patients, clinicians and care~     team members, and researchers; for effective use of data for guiding care, value,~     improvement, and research.~   "
20308|NCT02791373|"~     The purpose of this study is to determine whether the efficacy of gemcitabine is comparable~     with the efficacy of the standard chemotherapy with vinorelbine for mobilization of~     autologous stem cells in myeloma patients~   "
20272|NCT02791841|"~     The purpose of the present study is to compare the effectiveness of Rhythmic Reading~     Training (RRT), a computer-assisted intervention method that combines sublexical reading~     exercises with rhythm processing, and that of an intervention resulting from the combination~     of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific~     Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of~     the administration of only AVG is intended to be compared to other treatments. All~     interventions are administered for 13 hours over 9 days to a group of Italian students with~     DD aged 8-12.~   "
20273|NCT02791828|"~     Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of~     three treatment sessions per week extrarenal lasting 4 hours each. This treatment is~     necessary but it has an impact on the quality of life of patients.The investigators believe~     that to improve the overall quality of life in hemodialysis patients, the quality of each~     hemodialysis session must be improved. The quality criterion is not only medical, it must~     also take into account the patient's perception about the course of its meeting : that's~     what we call quality of experience of the dialysis session. Our daily healthcare practice~     shows that each hemodialysis session is experienced differently by the patient according to~     different factors : physical, psychological, relational, technical, temporal. The quality of~     the experience of a hemodialysis session could be positively influenced by the use of~     supplements occupational assets or liabilities, for improving patient satisfaction or by~     enhancing its relationship with the staff. Indeed, a preliminary study ( in the nephrology~     unit of our establishment in January 2012) of 8 patients undergoing active occupational~     educational activity during hemodialysis, showed that the experience of the hemodialysis~     session was potentially improvable (experienced patients improved, reduced cramps ... ).~     However, to assess the impact of such measures on the lives of the dialysis session and the~     quality of life in general, the investigators need to measure the quality of living of a~     dialysis session. There is not, at present, specific tool to measure the quality of the~     experience of a hemodialysis session. This tool would measure the impact of a caregiver~     support occupational during dialysis sessions. The main objective of this study is to create~     and validate an instrument to measure the quality of living of a hemodialysis of chronic~     renal insufficiency subject.~   "
20274|NCT02791815|"~     The primary purpose of this study is to evaluate the effect of repeated doses of selexipag~     on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much~     midazolam is present in the blood)~   "
20275|NCT02791802|"~     This multicenter multinational prospective two-arm matched-pair observational study aims to~     establish a prospective comparison of active lipoprotein apheresis treatment approved and~     conducted according to German guidelines for the indication of elevated Lp(a) versus a~     maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character~     and the inclusion of a control arm, this will be the first clinical study that can confirm~     the relevance of the established approach to use lipoprotein apheresis in those subjects and~     its effects to reduce the individual cardiovascular risk. The optimized management of~     subjects in the control group (not receiving lipoprotein apheresis) will also help to~     clarify the controversial issue, to which extent intensive medical care per se can influence~     the occurence of subsequent cardiovascular events. Primary objective of the trial is to~     evaluate the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial~     infarction, PCI, CABG and death from cardiovascular disease. The primary objective of this~     study evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with~     progressive cardiovascular disease, as accepted by the German Federal Joint Committee as~     indication for subjects with elevated Lp(a). Comparator will be matched subjects under~     maximum tolerated lipid lowering therapy without access to lipoprotein apheresis treatment.~     The clinical benefit will be defined as the reduction of the composite endpoint of major~     adverse cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG or~     death from cardiovascular disease over a period of at least 2 years after completion of~     visit 1b and until at least 60 events of the primary end-point occurred in group B. If the~     number of at least 60 documented primary endpoint events within 2 years of the completion of~     enrolment did not occur, the study will continue until this number of primary endpoint~     events has accumulated.~   "
20276|NCT02791789|"~     Use of the software could allow learning of reading code in subjects with ASD through the~     design of serious games for educational and therapeutic purposes.~      This SEMATIC software could improve communication and could be integrated into medical~     management (speech therapy and neuropsychological).~      The benefit of an action research will enable training professionals to autism, cognitive~     characteristics of autism and the use of IT support for this population.~   "
20277|NCT02791776|"~     The problem of choosing the supporting vertebra was the subject of several studies. They do~     not suggest as regards the techniques that are not currently used or with insufficient~     setback.~      The need to have a sufficient number of files with a minimum decline of 5 years for~     proposing a multicenter study that will be conducted within the framework of the Scoliosis~     Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015.~     the GES gathers most of the teams that support this pathology.~   "
20278|NCT02791763|"~     This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to~     compare the efficacy (verification of noninferiority) and safety of GSK1278863 administered~     for 52 weeks versus epoetin beta pegol in approximately 270 Japanese non-dialysis (ND) and~     50 peritoneal dialysis (PD) subjects with renal anemia.~      The study will consist of 2 cohorts of different subject populations. This study consists of~     a 4-week screening phase, a 52-week treatment phase (including the primary efficacy~     evaluation period [Weeks 40 to 52]), and a 4-week follow-up phase following the treatment~     phase.~      The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to~     epoetin beta pegol based on hemoglobin (Hgb) in the ND subject population included in this~     study. Study results will be used as pivotal study data for an NDA submitted for GSK1278863~     for the treatment of renal anemia in Japan.~   "
20279|NCT02791750|"~     Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its~     efficacy. The objective of this study is to know the women experience (persistence,~     treatment changes, quality of life) and its determinants, in a french population.~   "
20280|NCT02791737|"~     This pilot trial studies a structured exercise program intervention in improving physical~     activity in older patients with hematologic malignancies undergoing cancer therapy. Patients~     with hematologic malignancies are at an increased risk of functional dependence and injury.~     Structured exercise programs, such as the Otago exercise programme (OEP), may improve~     balance, strength, and prevent fall-related injury in older patients with hematologic~     malignancies undergoing cancer therapy.~   "
20281|NCT02791724|"~     The trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect),~     which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to~     Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current~     depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and~     randomized to two groups: (1) a control group, in which they may engage with any epilepsy~     treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three~     months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately~     receives six-month access to Desiconnect and may also use CAU. The primary outcome measure~     is the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three~     months post-baseline.~   "
20309|NCT02791360|"~     Through this study, the investigators believe to describe more accurately the damage caused~     by brain radiation therapy in the long term.~   "
29126|NCT02675894|"~     To determine safety, ablative zone, technical success rate and early safety data of recently~     introduced cool-wet electrode in eligible patients who are indicative for radiofrequency~     ablation (RFA) for liver tumors.~   "
20282|NCT02791711|"~     The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow~     Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.~      Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving~     the safety and efficacy of administering O2. This device generates a continuous positive~     pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at~     the nasal interface improves patient comfort and avoiding nasal trauma.~   "
20283|NCT02791698|"~     The investigators will conduct a prospective study, in which they will determine~     sensitivity, specificity and diagnostic accuracy of late evening urinary free cortisol~     concentration/creatinine and hair cortisol in differentiating Cushing's syndrome from~     Pseudo-Cushing's syndrome.~   "
20284|NCT02791685|"~     The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation~     program delivered via a smartphone application and regular telephone calls will lead to~     improved patient outcomes as measured by functional capacity, improved patient compliance in~     monitoring symptoms and medication adherence, improved self-efficacy and knowledge in~     managing disease and, a decreased rate of hospitalization and re-admissions.~   "
20285|NCT02791672|"~     The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to~     reconstruct the breast after cancerous tissue is removed. Over the years, improvements in~     surgical technique and pain control have decreased the length of stay in hospital after this~     procedure. Recently, early discharge after breast reconstruction using another very similar~     pedicled flap, called the transverse rectus abdominis flap, was shown to be safe,~     patient-centered, and associated with significant hospital cost-savings by another Canadian~     group.~      With increasing pressure from hospital administrators to weigh financial considerations into~     treatment decision making, doctors must test cost-saving strategies in order to ensure~     patient satisfaction and safety. Here, we plan to evaluate patient safety, satisfaction and~     cost efficacy in breast reconstruction using the pedicled latissimus dorsi myocutaneous~     flap.~      We hypothesize that patient care planning can allow for safe and cost-effective same-day~     discharge and improved patient satisfaction after autologous breast reconstruction using the~     pedicled latissimus dorsi flap. After nearly 10 successful same-day discharges using this~     flap, our experience at the Ottawa Hospital suggests that this practice is safe, has~     increased patient satisfaction scores, decreased narcotic use, no short or long term~     complications and is more cost effective compared to patients who stay overnight.~      In the present study, we hope to quantify our results by demonstrating that same day~     discharge is a cost effective strategy that does not compromise patient safety and~     satisfaction.~   "
20286|NCT02791659|"~     X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not~     only the patient, but the personnel of ERCP team may have the effect from the scattered ray.~     According to the automatic beam adjustment function, the thicker object (eg. lying left~     lateral) might produce higher scatter ray than thinner object (eg. lying prone). The~     investigators evaluate the radiation exposure among ERCP personnel compare between patient's~     2 different positions.~   "
20287|NCT02791646|"~     This trial is a sequential multiple assignment randomized trial (SMART), that will examine~     response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills~     Training [PCST]) and subsequent response-based adjustments to doses. Cancer patients with~     pain will initially be randomized to receive either PCST-Full or PCST-Brief. Participants~     who do not report pain reduction to their initially assigned intervention will be~     re-randomized to receive either maintenance or an increased level of intervention.~     Participants who report pain reduction to their initially assigned intervention will be~     re-randomized to either a maintenance dose or no further treatment. Intervention responses~     will be compared across conditions using a standard two-sided, two-sample t-test. Techniques~     typically used for SMART studies will be used to compare intervention dosage sequences~     across PCTS that adjusts to initial dosage based on patient responses. The risk and safety~     issues in this trial are low and limited to those common to a psychosocial intervention~     (e.g., loss of confidentiality).~   "
20288|NCT02791633|"~     Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of~     life and 'return to normal life' up to 1 year following emergency laparotomy~   "
20289|NCT02791620|"~     The objective of this study is to evaluate arm rejuvenation and tightening with a~     nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit~     20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano~     fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using~     %improvement of treated surface areas and skin elasticity using Dermalab the result at 3~     months after the last treatment and clinical improvements evaluated by two board certified~     dermatologist (using compared photos between before treatment and 3 months after the last~     treatment).~   "
20290|NCT02791607|"~     Head and neck squamous cell carcinoma (HNSCC) is the 4th highest incidence of cancer and 6th~     of cancer death of the males in Taiwan. Because the patients were mainly middle-aged male,~     the disease eventually resulted in a huge loss of labor force, productivity and a huge~     burden of family supports and medicinal costs. Unfortunately, the incidence and death of~     HNSCC seemed to be increasing in Taiwan. Currently, the primary treatments of HNSCC are~     mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent~     chemoradiotherapy. Compared to oral cavity cancer, patients with pharyngeal cancer would~     possibly harbor human papillomavirus (HPV) infections and have better treatment outcomes,~     prognosis and survival with clinically significance; however, the investigator's reports~     showed quite the opposite prognostic value in oral cavity cancer. The inconsistent data~     urges us to investigate further. Fortunately, in recent years, The investigator have~     developed a new method for isolation and detection of circulating tumor cells (CTCs) in~     HNSCC patients.The investigator's data found that high level of CTCs in patients with HNSCC~     and might be associated with disease prognosis, response to treatment and distant~     metastasis. This novel tool enhances the studies addressing on metastases or recurrence~     process in HNSCC patients. However, the investigator did not focus whether if the dynamic~     change of CTCs and specific surface markers on CTCs, such as P16INK4A -positive CTCs are~     clinically meaningful.~      Therefore, in the first year of this 3-year project, the investigator will utilize the~     investigator's developing device and protocol to isolate high-purity CTCs to further~     identify P16INK4A positivity on CTCs. In the following 2 years of the project, the~     investigator will enroll 150 freshly diagnosed patients with oral cavity, oropharyngeal,~     hypopharyngeal and laryngeal cancer at all stages (75 P16 INK4A -positive and 75 P16 INK4A~     -negative patients) and 30 healthy donors for cell line tests, and then analyze CTCs,~     background white blood cells signals, and their initial biopsied tissue for P16INK4A~     positivity test. Further statistical tests with clinical conditions (disease status,~     treatment effects, progression or distant metastasis and death) will be performed to~     elucidate their clinical significance. In addition, the investigator will also analyze the~     habitual status of alcohol; cigarette and betel nut use to P16INK4A-positive CTCs and~     attempt to understand their influence to P16 INK4A status dynamically. Hopefully, the~     investigator will clarify the clinical significance of circulating P16INK4A expression~     status on CTCs by this study and provide a new biomarker for clinical cancer care.~   "
20291|NCT02791594|"~     Up to 35 adult patients with metastatic melanoma will be enrolled in this study with a~     target enrollment of 30 evaluable subjects who complete the baseline and an approximately 3~     week FDG PET/CT scans, they may also complete an FDG PET/CT after 10 weeks of pembrolizumab~     therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then~     will be asked to have one additional tumor biopsy and one additional blood draw for the~     purposes of this imaging study. Subjects who are eligible for this imaging protocol will~     undergo a baseline FDG PET/CT scan as part of their clinical restaging prior to starting new~     therapy. A research FDG PET/CT will take place approximately 3 weeks post-therapy and a 3rd~     FDG PET/CT scan will be done at more than 10 weeks after starting pembrolizumab, this scan~     may be done as a clinical scan for evaluation of response or restaging after therapy,~     however, if it is not ordered as a clinical scan it will be done as a research scan. Changes~     in FDG uptake will be correlated with blood and tissue results from the patient's medical~     records and from the data collected as part of the Penn Melanoma Tissue Collection Program~     and with long term outcomes including progression free and overall survival.~   "
20292|NCT02791581|"~     This study is being done to see if patients receiving chemotherapy for breast cancer affects~     the heart, the ability to exercise and fatigue when compared to patients who do not have~     cancer.~   "
20293|NCT02791568|"~     The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance~     Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate~     the blood and oxygen flow to the placenta using advanced U/S and MRI testing.~   "
20294|NCT02791555|"~     The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone~     turnover and bone density in men and women with atrial fibrillation.~   "
20295|NCT02791542|"~     This will be a single site, mechanistic study of asthmatic subjects and healthy,~     non-asthmatic controls which will compare asthmatic smooth muscle cells to non-asthmatic~     smooth muscle cells collected from bronchial biopsies.~   "
20296|NCT02791529|"~     The use of electrocautery for surgical skin incision in general surgery is known to decrease~     post-operative pain. This study compares the use of scalpel and electrocautery for surgical~     skin incision in open carpal tunnel release (OCTR).~   "
20297|NCT02791516|"~     A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of~     6 months treatment with Romosozumab compared to placebo by determining the percent changes~     in bone mineral density~   "
20298|NCT02791503|"~     Irreversible electroporation (IRE) is a promising new ablation technique to fight pancreatic~     cancer. The primary aim of the CROSSFIRE trial is to compare the efficacy (in terms of~     overall survival) of FOLFIRINOX and IRE (experimental arm) to the efficacy of FOLFIRINOX and~     stereotactic ablative radiotherapy (SABR) (control arm) in patients with locally advanced,~     non-resectable, non-metastasized, pancreatic cancer (LAPC). Secondary outcomes are~     progression free survival, safety/toxicity, immunomodulation, tumor marker Cancer Antigen~     (CA) 19.9, quality of life (QoL), and total direct and indirect costs for each treatment arm~     (cost-effectiveness analysis).~   "
20299|NCT02791490|"~     This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus~     (T2DM) and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day),~     the effect of up-titration of metformin plus the addition of sitagliptin compared to~     up-titration of metformin alone on glycemic control. The primary hypotheses of this study~     are that up-titration of metformin to 2000 mg/day (1000 mg, twice daily [b.i.d]) plus the~     addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C)~     compared to metformin up-titration alone and that this treatment is safe and well-tolerated.~   "
20300|NCT02791477|"~     Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty~     evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6~     weeks, 3, 6, 12 and 24 months postoperative.~   "
20301|NCT02791464|"~     The pilot study investigates the potential benefits of the Transcendental Meditation program~     in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned~     to either the TM program or a wait list control group for a period of four months.~   "
20302|NCT02791451|"~     This is an open-label single-center 6-month prospective clinical trial predicting~     exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep~     in patients admitted to the pulmonary ward of the Turku University Hospital due to acute~     exacerbation of COPD.~   "
20303|NCT02791438|"~     The purpose of this study is to evaluate the safety of administration of TAK-536 in~     pediatric patients aged 6 to less than 16 years with hypertension.~   "
20304|NCT02791425|"~     Objectives:~      Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked~     Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of~     common patient needs in alert mechanically ventilated patients in the Intensive Care Unit~     (ICU).~      Specific Aim 2: To determine patient, family and bedside nurse satisfaction with~     communication using the BCI device and elicit open-ended feedback to guide future device~     improvements~      Design:~      Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system~     to facilitate communication in intubated patients, with sequential use of the BCI device and~     a picture board.~      Selection of the primary self-identified primary patient need on the BCI device will be~     compared to the icon selected on the picture board (reference standard). A patient~     satisfaction survey will then be provided to the patient or a family member following use~     for 2 hours a day for 3 consecutive days.~      Primary outcome: Accurate selection of the illustrative icon on the brain computer interface~     representing the physical or emotional need self-identified by the patient as being the most~     common trigger for communication with the bedside nurse during their admission.~      Secondary outcome: Selection by patients or family of agree or strongly agree with the~     statement The Brain computer interface device allowed me to communicate my needs to the~     bedside nurse adequately.~      Intervention: Use of the brain computer device in the ICU for communication for 2 hours a~     day for 3 consecutive days~      Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3~     consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically~     ventilated but alert patients in the Intensive Care Unit~   "
20305|NCT02791412|"~     The purpose of this study is to evaluate long-term outcome of treatment(percutaneous~     coronary intervention or coronary-artery bypass graft) in unprotected left main coronary~     artery stenosis in Korea.~   "
20306|NCT02791399|"~     This is a randomized controlled trial of a multifaceted intervention designed to improve the~     safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a~     multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid~     safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship,~     and (c) explore to what extent ISOP is associated with changes in pain and pain-related~     function.~   "
20444|NCT02789592|"~     The purpose of this study is to determine whether melatonin prolonged-release (PR) and~     clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder~     (RBD) of patients with Parkinson's disease (PD).~   "
20310|NCT02791347|"~     Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated~     with severe gastrointestinal toxicity, commonly compromising patients' food intake,~     nutritional status and functioning level. Malnutrition has been associated with worse~     functional status, reduced survival, increased rate of infections, complications,~     hospitalizations, and therapy toxicity in oncology patients.~      To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition~     intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The~     proposed study is a single center, prospective, RCT with a parallel design that aims to~     assess the impact of a nutrition intervention on the nutritional and functional statuses of~     SCT recipients 100 days post SCT.~   "
20311|NCT02791334|"~     The main purpose of this study is to evaluate the safety and tolerability of anti-programmed~     cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced~     refractory solid tumors.~   "
20312|NCT02791321|"~     Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the~     phenotypic model (5 clinical criteria) or the cumulative model (various clinical and~     biological criteria). Currently, aging with autism spectrum disorder and mental retardation~     (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may~     present an early aging.~      Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20~     years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with~     details health according to age, and to verify the frailty index validity for predicting~     falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.~      This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years~     and living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the~     time of inclusion. Frailty index is calculated from 104 clinical and biological criteria.~     Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and~     intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss~     scale, DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every~     year during 5 years.~      The connection between frailty index and age will be studied using linear regression. The~     frailty index validity will be analysed using ROC curves. Modelisation of the falls,~     hospitalisations or death risk in the 5 years after the initial evaluation will help in~     identification of the more frailty predictive criteria.~   "
20313|NCT02791308|"~     The purpose of this study is to compare the safety and efficacy profiles of Watson~     Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North~     America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of~     the two active creams over that of the placebo (Vehicle of test product), in the treatment~     of mild to moderate atopic dermatitis.~   "
20314|NCT02791295|"~     The purpose of the study is to determine whether a personalized lifestyle intervention~     focused on diet and physical activity reinforcement is effective in avoiding weight gain in~     the first months following initiation of subcutaneous insulin pump therapy in type-2~     diabetic patients.~   "
20315|NCT02791282|"~     Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a~     diagnostic strategy for patients with suspected CTEPH where positive findings are verified~     with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography~     (CTPA)~   "
20316|NCT02791269|"~     This is an expanded access, multicenter, national, open-label, and non-randomized study to~     analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen~     (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48~     weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free~     follow-up period.~   "
20317|NCT02791256|"~     This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of~     increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6~     CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin.~     The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24~     weeks).~   "
20318|NCT02791243|"~     This study evaluates the potential for induction of photosensitization by P-3074 0.25%~     finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a~     negative control (0.9% sodium chloride, NaCl)~   "
20319|NCT02791230|"~     Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg~     tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type~     transthyretin resulting in amyloid cardiomyopathy~   "
20320|NCT02791217|"~     MiRNAs are small (~19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a~     sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level.~     MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell~     cycle, hematopoietic differentiation and have been implicated in the development and~     progression of several types of cancers, including hematological malignancies.~     Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of~     epigenetic silencing can all lead to oncogenic pathways.~      Hematologic cancers, which are caused by the malignant transformation of bone marrow cells~     and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma,~     and multiple myeloma. To date, some of the hematological malignancies are very aggressive~     that early diagnosis is essential for improving prognosis and increasing survival rates.~     However, current diagnostic methods have various limitations, such as insufficient~     sensitivity, specificity, it is also time-consuming, costly, and requires a high level of~     expertise, which limits its application in clinical contexts. Thus, development of new~     biomarkers for the early detection and relapse of hematological malignancies is desirable.~      Some of the innate properties of miRNAs make them highly attractive as potential biomarkers.~     MiRNAs can be readily detected in small volume samples using specific and sensitive~     quantitative real-time PCR; they have been isolated from most body fluids, including serum,~     plasma, urine, saliva, tears and semen and are known to circulate in a highly stable,~     cell-free form. They are highly conserved between species, allowing the use of animal models~     of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release~     miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of~     patients with cancer. A growing number of publications confirm that miRNAs can be a useful~     biomarker for hematological malignancies diagnosis and progression.~   "
20321|NCT02791204|"~     This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization~     treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the~     disease can progress more quickly than in patients without diabetes.~   "
20322|NCT02791191|"~     The main purpose of this study is to evaluate the safety and the effect on brain tau of the~     study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.~   "
20323|NCT02791178|"~     The overall objective of this research proposal is to use OCT to investigate those~     morphological culprit plaque characteristics associated with the risk of developing MVO in~     reperfused STEMI patients.~   "
20324|NCT02791165|"~     There is an optimal day on which to perform the CMR scan which allows one to capture the~     information required to assess the dynamic changes in the reperfused STEMI patient. The main~     objective is to characterise the dynamic changes in LV function, MI size, myocardial edema,~     MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute~     reperfused STEMI in order to identify the optimal day for performing the CMR scan.~   "
20325|NCT02791152|"~     A prospective cohort of relatively healthy individuals, using comprehensive clinical~     information, advanced imaging (including cardiac MRI), cardiovascular exercise physiology,~     metabolomics and genetic analysis. These findings will be correlated with adverse clinical~     outcomes including death, stroke and myocardial infarction. In selected cases, follow-up~     imaging and biomarker samples will also be obtained. These studies will enable us to begin~     to address a critical gap in our knowledge as to how best to interpret the very large amount~     of cardiovascular tests done in Singapore and how to better to predict outcomes and manage~     healthcare costs in our local populations~   "
20326|NCT02791139|"~     The investigators aim to investigate the association of midlife dietary and lifestyle~     factors on cardiac functional changes in the elderly. The investigators hypothesize that~     even in those without clinically manifest cardiovascular disease, the extent of underlying~     abnormalities in cardiovascular structure and function in the elderly would be independently~     related to midlife dietary and lifestyle factors.~   "
20327|NCT02791126|"~     Heart failure is a major health care burden. It can occur with either normal or reduced LV~     ejection fraction, depending on different degrees of ventricular remodelling. The~     investigators recently published a new method, curvedness-based imaging. The investigators~     have also reported the diagnostic utility of curvedness-based imaging in various cardiac~     diseases. The investigators now propose to prospectively assess curvedness-based imaging for~     diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction,~     and examine left ventricular systolic and diastolic function and predicts the prognosis in a~     cohort of HF patients.~   "
20328|NCT02791113|"~     The investigators propose to develop a computational framework involving a novel automatic~     image segmentation algorithm based on CTA images, an artery model reconstruction algorithm~     for stenosis detection, and quantification of severity of stenosis in terms of area~     stenosis.~   "
20329|NCT02791100|"~     Young children in Ethiopia lack sufficient protein and micronutrients for growth and~     development. The overall purpose is to assess the effects of promoting egg and eggshell~     powder consumption on improving the nutritional status of children 6 to 15 months in Halaba~     Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs~     (egg and eggshell) for young children will improve growth in otherwise malnourished young~     children. Upon providing chickens, the nutritional status of young children prior and after~     the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude~     and practices (KAP) of mothers on egg and eggshell powder consumption by their children~     before and after the intervention in the intervention group will be done. Caregivers will be~     instructed to give each child 1 egg (cooked) and 1/4 bottle cap of eggshell (500 mg~     calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall~     nutritional status. Throughout the study, any problems arising in keeping chickens will be~     recorded in order to assess the feasibility and practicality of raising chickens as way to~     improve nutritional status of young children. The study is novel in that investigators are~     providing a way to have increased protein, increased micronutrients, and use of eggshell as~     a source of calcium.~   "
20330|NCT02791087|"~     CFD simulations in this study provide detailed hemodynamics information, which cannot be~     obtained from cardiac images alone. The investigators hypothesize that our proposed~     simulations will provide strong correlation between hemodynamic parameters, such as WSSG and~     SPA, and clinically identified graft stenosis. These correlations will allow the~     investigators to identify the future patients at high risk of graft stenosis and lead to~     future researches on optimizing and refining surgical plans, such as finding optimal~     proximal and distal anastomoses locations, optimal graft length and diameter, which could~     lead to improved longevity of the graft. Once CFD coupled shape optimizer is validated, it~     could be part of the surgical simulator to help in training the next generation physicians.~     It could provide new viewpoints for assessing whether some modified surgical techniques are~     better or not. It could also aid in designing and evaluating the vascular medical devices,~     including stent, artificial graft, and etc., which would lead to better surgical outcome.~   "
20331|NCT02791074|"~     This proposed study aim to:~        1. Determine intra-LV pressure-time profile non-invasively using recently developed echo~          Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF~          subjects (both HFNEF and HFREF) compared to normal volunteers.~        2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.~   "
20332|NCT02791061|"~     The primary aims of this study are to 1. Develop an automated method of quantitation of RV~     remodeling in terms of regional RV surface curvature and area strain and assess the~     feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF,~     patients with PS~      The secondary study aims of this study are to~      1. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex~     and age-matched controls 2, Assess the relationship of our proposed parameters to global RV~     function and exercise capacity in repaired TOF patients and PS patient~   "
20333|NCT02791048|"~     This study aims to find out if music therapy is effective in improving the quality of life~     of palliative care patients. It will do this by comparing palliative care patients who~     receive music therapy with those who do not receive music therapy.~   "
20334|NCT02791035|"~     The purpose of this study is to examine the correlation between change of HbA1c, urinary~     glucose excretion and other factors when ipragliflozin is added to preexisting therapy in~     subjects with type 2 diabetes.~   "
20346|NCT02790879|"~     The main objective of register-SAFETIM is to assess the impact of the transition from~     pediatric to adult cystic fibrosis care center on changes in lung function and nutritional~     status of patients.~      This is a multicenter, observational, longitudinal, with analysis of the French national~     registry data of patients with cystic fibrosis.~      Our study will assess the clinical features of adolescent patients with cystic fibrosis~     during the transition from pediatric care to adult care. It will explore factors associated~     with the impact of the transition on the clinical course of adolescent patients (respiratory~     and nutritional functions).~   "
20335|NCT02791022|"~     Atrial fibrillation is a common disease in the aging population that has severe implication~     if left untreated as it leads to embolic stroke and other embolic phenomenon. Embolic stroke~     in particular has severe implications to our community as the cost of care for such immobile~     patients can be extremely high. Atrial fibrillation typically begins as Paroxysmal atrial~     fibrillation (PAF), which makes early detection extremely difficult as the PAF may only~     occur transiently in the initial stages. Long term continuous ECG monitoring is currently~     required over weeks to detect early PAF. Current devices typically need to be implanted~     (loop recorders) to be sensitive enough to detect infrequent episodes of PAF. New generation~     ECG remote devices (non-invasive) are however now available that are wearable over long~     periods and can send data directly to a database for centralized collection and analysis of~     the data. The aim of this study will be to use such a device to evaluate the incidence of~     PAF in different population of patients, with each patient wearing and sending continuous~     ECG data for periods of a week or more to a central database, across several public~     hospitals in Singapore.~   "
20336|NCT02791009|"~     To build on Singapore's competitive advantages in advanced cardiac imaging, genetic and~     molecular studies to develop an integrated one -stop platform spanning from human to large~     and small animal models, dedicated to deepening the understanding of CV disease progression,~     discovery of new targets and repurposing of drugs.~   "
20337|NCT02790996|"~     The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised~     dosing to a standard dosing regimen of vancomycin in neonates and infants aged less than 91~     days with late onset bacterial sepsis known or suspected to be caused by Gram-positive~     microorganisms~   "
20338|NCT02790983|"~     Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients~     will be collected and evaluated to investigate the prognostic factors which influence~     survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups~     of patients diagnosed with primary spinal column tumors.~   "
20339|NCT02790970|"~     Depression is a very common, serious and in some cases life‐threatening condition, affecting~     around 350 million people globally. Approximately 11% of citizens in the European Union~     suffer from depression at some point in their lives. Depression is associated with~     significant socio-economic costs and has been predicted to become the greatest cause of~     disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30~     million patients with depression in Europe, with aggregated economic costs of approximately~     €92 billion . Improvements in managing the treatment of depression are urgently needed to~     improve patient outcomes, contain rising healthcare costs, improve workplace productivity~     and help to address global economic and societal challenges.~      While a range of effective antidepressant medications are available to treat depression, it~     takes 4-6 weeks after starting antidepressant treatment before a physician can detect~     whether the treatment is working. However, surprisingly, more than 50% of patients fail to~     respond to the first antidepressant treatment they are prescribed. Therefore, it often takes~     several months to identify an effective antidepressant treatment for the majority of~     patients with depression. During this time a patient's ability to work and function socially~     is severely impaired. Individuals may be absent from work for many weeks or months and this~     places a substantial burden on the economy and on healthcare resources.~   "
20340|NCT02790957|"~     Chronic non-healing wounds represent a major source of morbidity, disability, and mortality~     in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations~     worldwide. Many patients with ischemic or neuroischemic wounds are not candidate to~     surgical/endovascular revascularization, owing to anatomical vascular reasons or for the~     underlying conditions and co-morbidities. Therefore, identification of novel medical~     treatment strategies to improve wound healing in diabetic patients is a major challenge for~     clinicians, researchers, and health care systems.~      Defects in bone marrow (BM)-derive stem and progenitor cells, including EPCs (endothelial~     progenitor cells), contribute to diabetic complications. Stem cell mobilizing agents have~     been previously studied as an adjunctive therapy for critical limb ischemia and chronic~     non-healing wounds in diabetic and non-diabetic patients, as well as for the treatment of~     diabetic wound infections . Meta-analyses of such studies indicate that stem cell~     mobilization in these clinical conditions is safe and potentially effective in improving~     surrogate outcome measures and hard endpoints (such as rates of wound healing and~     amputation).~      This study plans to evaluate whether a single injection of Plerixafor improves wound healing~     in diabetic patients with stage III-IV (neuro)ischemic wounds.~   "
20341|NCT02790944|"~     The primary objective of the study will be to estimate the prevalence of germline mutations~     in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic~     ductal adenocarcinoma.~   "
20342|NCT02790931|"~     The main objective of this trial is to investigate the effects of a personalized~     intervention of exercises for the ankle-foot complex, supervised by a physical therapist and~     also via software, in gait velocity of patients with diabetic neuropathy.~   "
20343|NCT02790918|"~     In this study, we aim to i) evaluate the accuracy of 3D IVS curvedness for prediction of RV~     systolic pressure (RVSP), mean pulmonary artery pressure (mPAP) and pulmonary vascular~     resistance (PVR) with RHC; ii) evaluate the usefulness of 3D IVS curvedness for predicting~     the response to vasodilator challenge with RHC, in patients clinically suspected or known to~     have primary PH.~   "
20344|NCT02790905|"~     The objective of this study is to validate the Patient Health Questionnaire-9 (PHQ-9) and~     the Refugee Health Screener-15 (RHS-15) screening tools for depression in pregnant and~     post-partum migrant women on the Thai-Myanmar border.~   "
20345|NCT02790892|"~     The Creative Arts Diabetes Initiative will offer facilitated art therapy with a~     group/peer-support environment to two groups of youth/young adults, one with type 1~     diabetes, and one with type 2 diabetes. This environment intends to meet youth where they~     are, promote universality, hope and self-understanding, has the potential to be therapeutic~     and allows youth to express and learn about themselves and each other while developing~     healthy coping skills and address their fears and concerns.~   "
20347|NCT02790866|"~     This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based~     decision aid designed to facilitate informed decision making about participation in lung~     cancer screening among individuals at high risk of lung cancer due to heavy cigarette~     smoking.~   "
20351|NCT02790814|"~     Annually, an estimated 2.6 million still births occur half of which die during labor and~     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth~     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths~     take place in low-income countries where the provider/patient ratio is low and fetal~     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify~     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these~     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called~     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.~     This project will compare the effectiveness of automatic use of Moyo versus intermittent use~     of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized~     control study, at Haydom Hospital, Tanzania.~   "
20352|NCT02790801|"~     The purpose of this study is to evaluate the management of chronic heart failure patients~     with atrial fibrillation, to collect data on compliance with clinical guidelines and the~     prevalence of long-term anticoagulant therapy,complications. The results will be used to~     develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of~     such patients.~   "
20353|NCT02790788|"~     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors~     plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose~     steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain~     perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will~     also be followed for organ dysfunction, potential, steroid-associated complications, and~     functional outcome at hospital discharge.~   "
20354|NCT02790775|"~     In this double blind clinical trial, 1000 patients suffering from diabetic macular edema,~     age-related macular degeneration, neovascularization due to proliferative diabetic~     retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included.~     Those with the history of Ocular pain prior to the procedure, any contraindication for~     Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions~     that could affect pain sensation, history of using systemic analgesic or sedative~     medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and~     bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are~     excluded from the study. Before starting the treatment all patients undergo complete~     ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness~     measurements using optical coherence tomography (OCT). Patients are randomly assigned to~     each group .Each participant receive one injection in one eye in this study. Pain is~     measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA~     and OCT would be checked again at month one.~   "
20355|NCT02790762|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.~   "
20356|NCT02790749|"~     Although evidence is amassing regarding the role of intra-articular pathology in the~     surgical management of adolescents and adults with hip dysplasia, the optimal method of~     detection and especially management of this pathology remains unclear. No studies exist to~     compare clinical outcomes and hip survival between arthroscopy and arthrotomy in patients~     with mechanical hip pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this~     is what the investigators aim to achieve in the current prospective randomized surgical~     trial.~   "
20357|NCT02790736|"~     The study will test the efficacy of propranolol or placebo, administered after retrieval of~     a previously acquired public speaking fear, in reducing fear and avoidance of public~     speaking.~   "
20358|NCT02790723|"~     This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra~     delivered by intra-articular injection into one knee joint of patients with moderate OA of~     the knee.~   "
20359|NCT02790710|"~     The study will test the efficacy of propranolol or placebo, administered after reactivation~     of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and~     avoidance in OCD.~   "
20360|NCT02790697|"~     This study aims at validating the accuracy of the new indirect calorimeter (Quark RMR 2.0,~     COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will~     only be conducted in Geneva center.~      The measurements made with the new calorimeter will be compared to the measurements by the~     mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition~     analysis.~   "
20361|NCT02790684|"~     This is a Phase 1, open-label, single-center, non-randomized study to assess the mass~     balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of~     age, inclusive. The radiolabeled investigational medicinal product will be administered to~     12 healthy male subjects in 2 cohorts of 6 subjects each.~   "
20362|NCT02790671|"~     Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of~     single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.~   "
20363|NCT02790658|"~     Investigate the bioavailability of the main flavonoid, their colonic transformation and~     untargeted metabolites by an metabolomic approach following acute intake of a grumixama~     juice by humans.~   "
20373|NCT02790515|"~     This study seeks to examine treatment therapy that will reduced regimen-related toxicity and~     relapse while promoting rapid immune reconstitution with limited serious~     graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life.~     The investigators propose to evaluate the safety and efficacy of selective naive T-cell~     depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell~     transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in~     patients with hematologic malignancies that have relapsed or are refractory following prior~     allogeneic transplantation.~      PRIMARY OBJECTIVE:~        -  To estimate engraftment by day +42 post-transplant in patients who receive~          TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation~          following reduced intensity conditioning regimen without radiation.~      SECONDARY OBJECTIVES:~        -  Assess the safety and feasibility of the addition of Blinatumomab in the early~          post-engraftment period in patients with CD19+ malignancy.~        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival~          at one-year post-transplantation.~        -  Estimate incidence and severity of acute and chronic (GVHD).~        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after~          transplantation.~   "
20364|NCT02790645|"~     Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and~     economic implications (risk of complications, disability ...) (healthcare costs). Strict~     glycemic control and intensive treatment and support have shown long-term patient with type~     1 diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the~     administration of insulin through 3 or more injections per day (MDI), or through a~     continuous subcutaneous insulin infusion (CSII). New technologies applied to the treatment~     of DM1, such as telemedicine, could bring benefits to patients. The available scientific~     evidence to date shows that telemedicine systems have beneficial or neutral effects on~     glycemic control, expressed in terms of HbA1c in patients with type 1 diabetes treated with~     MDI or CSII. They have also shown not to worsen the quality of life and reduce the costs~     associated with the care of these subjects. However, studies published to date are generally~     short follow-up, small sample size, and have not evaluated other biological parameters such~     as glycemic variability, inflammatory markers and markers of oxidative stress as well as a~     psychological assessment including depression, anxiety, Diabetes-related distress and fear~     of hypoglycemia. It has been designed a randomized crossover 18 months in order to study the~     effect of a telemedicine program in a group of subjects with DM1 in CSII on clinical~     variables of metabolic control variables, including parameters of glycemic variability,~     markers of inflammation and oxidative stress, psychological variables and quality of life,~     and associated costs.~   "
20365|NCT02790632|"~     This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal~     subarachnoid hemorrhage.~   "
20366|NCT02790619|"~     The purpose of this study is to determine if a new technology applied while listening to a~     mindfulness meditation tape can affect one's ability to achieve a state of mindfulness.~     The new technology is called transcranial direct current stimulation, or tDCS.~   "
20367|NCT02790593|"~     Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy~     which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an~     alternative solution for the long-term treatment of patients with venous ulceration. This is~     a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to~     determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for~     patients with venous ulceration compared to bandaging. Secondary outcome measures include~     whether the Juxta-Cures™ device improves patient compliance and quality of life compared to~     bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.~   "
20368|NCT02790580|"~     Background: The investigators previously studied the addition of low-dose, short-course~     sunitinib to pre-operative chemotherapy in the neoadjuvant setting in newly diagnosed breast~     cancer patients with measurable primary breast tumor in a phase Ib/II study at the National~     University Cancer Institute, Singapore. These data showed that the addition of sunitinib~     improved tumor vascularization as hypothesized with enhanced short-term treatment response.~     However, pathological complete response rate after 4 cycles of chemotherapy was not superior~     to standard chemotherapy, and may be attributed to dose delays from increased~     myelosuppression with the addition of sunitinib. The investigators hypothesize that this~     promising regimen may be further optimized with the use of growth factor support. The~     investigators thus plan to study the addition of low-dose, shortcourse sunitinib to~     dose-dense doxorubicin/cyclophosphamide (ddAC) administered every 14 days, supported by~     pegfilgrastim.~      Aim: To confirm that the addition of 12.5mg sunitinib for 5-7 days can be added before each~     cycle of ddAC (delivered every 14 days, supported by pegfilgrastim) without compromising~     dose intensity, in phase II open label single arm part of the study, followed by a phase II~     randomized study to compare the pathological complete response rate of ddAC versus sunitinib~     + ddAC in stage I-III HER2 negative breast cancer patients in the neoadjuvant setting.~      Methods:A single-centre study comprising two phases: a. Phase II open label single-arm study~     that will enroll newly diagnosed stage I-IV HER2 negative breast cancer patients receiving~     either neoadjuvant chemotherapy (stage I-III patients) or first-line palliative chemotherapy~     (stage IV patients). All patients will be treated with 4 cycles of ddAC at standard doses~     (60/600mg/m2) every 2 weeks, supported by subcutaneous pegfilgrastim 6mg, to be administered~     24-36 hours after each dose of chemotherapy. Low dose sunitinib at 12.5mg daily orally will~     be administered for 7 days prior to cycle 1 ddAC, and for 5 days prior to each subsequent~     cycle of ddAC. b. Phase II randomized study that will enroll newly diagnosed stage I-III~     HER2 negative breast cancer patients receiving neoadjuvant chemotherapy before definitive~     breast cancer surgery. Eligible patients will be randomized 1:1 to 4 cycles of ddAC with or~     without intermittent sunitinib in patients with measurable primary breast cancer who are~     receiving preoperative chemotherapy.~   "
20369|NCT02790567|"~     The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in~     surgical critically ill patients. If the use of rapid immunological diagnostic methods and~     pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of~     these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.~   "
20370|NCT02790554|"~     Annually, an estimated 2.6 million still births occur half of which die during labor and~     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth~     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths~     take place in low-income countries where the provider/patient ratio is low and fetal~     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify~     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these~     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called~     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.~     This project will compare the effectiveness of automatic use of Moyo versus intermittent use~     of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control~     study, at the University hospital, Dar es Salaam, Tanzania.~   "
20371|NCT02790541|"~     Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis,~     increased tissue blood flow and oxygenation correlated with tissue function.~      Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned~     organs associated with aging-related malfunctions due to restored mitochondrial function,~     mobilization of stem cells and induction of angiogenesis.~   "
20372|NCT02790528|"~     The purpose of this study is to evaluate whether statin is effective in the treatment of~     vasospastic angina.~   "
20384|NCT02790372|"~     This study evaluates the effect of using comprehensive geriatric assessment in combination~     with case conferences on the prevalence of neuropsychiatric symptoms (also known as~     behavioral and psychological symptoms of dementia) in Norwegian nursing homes~   "
20405|NCT02790099|"~     Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital~     stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective~     pain control. However, it is associated with significant side effects including nausea,~     vomiting and itchiness. Also, it is not suitable in all patients, for example, those with~     morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves~     injection of local anaesthetic agents into the rectus sheath space before closure of the~     wound. It has been shown to provide adequate pain control with less systemic side effects.~     The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and~     intrathecal morphine in post-Caesarean section pain control.~   "
20374|NCT02790502|"~     Globally, about one-third of edible food is lost or wasted 1. Wasted food depletes resources~     used to produce the food (as a matter of definition, produce includes all activities to~     distribute, package and prepare food for human consumption at any venue, but does not~     include growing, transporting and processing), deprives hungry people from needed nutrition~     and represents the most common (>20%) and most environmentally deleterious component (in~     terms of greenhouse gas) of US landfills3-6. The Organization for Economic Co-operation and~     Development (OECD) identified reducing FW as a key to increasing global food security (OECD~     2011) 7. The Obama Administration recently announced a first ever FW reduction goal for the~     United States of 50% by 2030. USDA and EPA will pursue this goal via partnerships with the~     private sector, charitable and faith-based organizations, as well as state, local and tribal~     governments.~      In developed economies, consumers are the largest source of FW via home preparation and~     dining out2, 8. In order to achieve FW goals, we must anticipate how consumer FW generation~     and handling decisions will respond to proposed policies and interventions. However, there~     exist substantial barriers to measuring consumer FW: existing methods have high respondent~     burden and yield biased measurements of FW generation9-11. In this project we will test a~     smartphone application (app) for measuring household FW.~   "
20375|NCT02790489|"~     The objectives of this clinical study are to determine the tolerance of dietary supplement~     Valedia (blend of plant extracts) through the evaluation of several parameters :~        -  Various blood biological parameters for tolerance (preprandial): blood glucose,~          insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol,~          LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase~          alcaline, bilirubine, urea.~        -  Urinary parameters: urea, creatinine.~        -  Hemodynamic parameters: heart rate and blood pressure.~        -  Cardiac function: ECG.~        -  Weight.~   "
20376|NCT02790476|"~     In collaboration with the San Diego Medical Examiner's Office and the State of California's~     controlled Substance Utilization Review and Evaluation System (CURES), the investigators~     propose to review opioid poisonings over the past 12 months and will send letters to~     prescribers in California when at least one of the provider's prescription(s) was filled by~     a patient who died of an opioid poisoning in San Diego County. The letters will be~     non-judgmental and factual, explaining that a patient of the provider who was being treated~     with prescription narcotics died of an opioid poisoning. The letter will also encourage~     judicious prescribing including use of the CURES system before prescribing. The~     investigators will evaluate physician prescribing practices over 24 months 12 months pre-~     and 12 months post-letter using data from the CURES database. The investigators' hypothesis~     is that letters will make the risk of opioids more cognitively available and that physicians~     will respond by prescribing opioids more carefully. This will result in fewer deaths due to~     misuse and more frequent use of the CURES system.~   "
20377|NCT02790463|"~     The overarching goal of the investigators project is to identify best practices in gout and~     hyperuricemia management, translate these evidence-based practices into a highly~     generalizable strategy for optimal delivery of gout care, and implement and evaluate such a~     strategy in a large, population-based healthcare setting. With the use of novel but~     readily-accessible technology, the investigators will examine the use of a novel,~     large-scale, and relatively low-cost pharmacy-based intervention, with the goal of~     optimizing urate lower therapy (ULT) in chronic gout treatment.~   "
20378|NCT02790450|"~     Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a~     relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition~     of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a~     well known inhibitor of the TMEM16A channel and is used in patients with gout.~      In this pilot study the investigators plan to investigate if Benzbromarone has an acute~     effect on the pulmonary arteries in humans. This will be investigated within the frame of a~     right heart catheterization performed in patients with known PAH due to clinical reasons.~     The investigators hypothesize that the application of Benzbromarone leads to pulmonary~     vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In~     addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge~     pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical~     reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic~     changes upon NO and Benzbromarone may be compared.~   "
20379|NCT02790437|"~     The purpose of this study is to evaluate the effectiveness of the study drug IdeS in~     patients who are on the waiting list for kidney transplant and have previously undergone~     desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.~     At study entry, the patients will have an available deceased or live donor with a positive~     crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific~     Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.~   "
20380|NCT02790424|"~     Parameters, sequences or paradigms optimisation in view of data quality and relevancy~     improvement.~   "
20381|NCT02790411|"~     Parameters, sequences or paradigms optimisation in view of data quality and relevancy~     improvement.~   "
20382|NCT02790398|"~     The aim of this study is to assess the differential effect of two transdiagnostic treatment~     protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized~     pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified~     Protocol; and b) a version of this protocol that also includes a specific component to~     address the regulation of positive affect (TTP+PA). Another aim was to assess the~     acceptability of both treatments by patients. It was hypothesized that the intervention~     would result in significant differences in favor of the TTP+PA protocol in all measures.~     Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be~     well-accepted by the two groups of participants.~   "
20383|NCT02790385|"~     Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and~     post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy~     children who undergo scoliosis surgery. The purpose of our study is to compare the effect of~     NPWT on infection rates when compared to standard gauze dressing. Participants will be~     randomized to the NPWT or standard dressing group. We will compare infection rates~     between the two groups. We hypothesize participants in the NPWT group will have a lower~     infection rate.~   "
20385|NCT02790359|"~     The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection~     of gastrointestinal-tract pathology in children has been established during the last three~     decades. Insufflation of the intestinal tract, usually with room air, is necessary to~     improve visualization during the procedure; however, air in the bowels can also result in~     abdominal distension and increased pain. This potential discomfort associated with upper~     endoscopy and colonoscopy may be an important barrier to patients undergoing this procedure.~     Insufflation with carbon dioxide is another method used in endoscopic procedures for~     distention of the lumen and is currently used at the Children's Hospital of Wisconsin based~     on provider preference. The aim of this study is to perform a randomized controlled trial~     comparing insufflation with room air to carbon dioxide in patients undergoing routine upper~     endoscopy and colonoscopy. The investigators primary outcome is measurement of patient~     comfort level as measured by pain scores during recovery. The investigators hypothesize that~     carbon dioxide insufflation during endoscopy and colonoscopy improves patient comfort level~     as compared with insufflation with room air. Secondary outcome measures include changes in~     end tidal carbon dioxide, time to discharge, duration of colonoscopy and cecal intubation~     rate, changes in abdominal girth, rescue pain medications used during recovery and~     post-procedure events. This is a prospective randomized single-blinded study. The~     investigators will recruit consecutive patients, between the ages of 8 and 21 years,~     scheduled for elective outpatient upper endoscopy and colonoscopy at children's hospital of~     Wisconsin from March 2015 until we reach target population numbers. The investigators will~     exclude all inpatients, non-English speaking patients, children under 8 years of age,~     patients undergoing colonic manometry studies, and patients with hemodynamic instability,~     gastrointestinal bleeding, acute abdomen, previous colectomy, oxygen-dependent pulmonary~     disease and obstructive sleep apnea requiring the use of continuous positive airway pressure~     device. On the basis of a computer-generated randomization scheme in a 1:1 ratio, patients~     will be assigned to receive room air or carbon dioxide for insufflation during colonoscopy.~     Power calculation was done and determined that we will need to enroll 100 patients in each~     arm of the study. Informed consent will be obtained from all patients by the endoscopist or~     gastrointestinal fellow.~   "
20386|NCT02790346|"~     This study should refine our surgical indications and to establish a decision tree of~     medical and surgical treatment of this common and troublesome strain functionally which is~     equino-varus.~   "
20387|NCT02790333|"~     The purpose of this trial is to establish an objective criterion for assessing pancreatic~     stump texture, and unify stapler cartridge according to pancreatic stump texture and~     thickness.~   "
20388|NCT02790320|"~     The purpose of this study was to evaluate the efficacy and safety of eribulin in standard~     clinical practice in patients with locally recurrent or metastatic advanced breast cancer.~   "
20389|NCT02790307|"~     Tibial nerve stimulation (TNS) has been recognised as a safe and effective treatment for the~     management of overactive bladder (OAB) symptoms. The aim of this study was to evaluate~     safety, acceptability and pilot efficacy of transcutaneous TNS using a novel device.~   "
20390|NCT02790294|"~     This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI)~     in management of spine tumors. Currently the standard of care is obtaining an MRI scan in~     the early postoperative period (within 72 hours after surgery). The purpose of this study is~     to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.~      In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients~     will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.~   "
20391|NCT02790281|"~     The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with~     active moderate to severe ulcerative colitis or Crohn's disease.~   "
20392|NCT02790268|"~     To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and~     in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring~     positioning in relation to surrounding ocular structures, in pediatric eyes~   "
20393|NCT02790255|"~     The whole body calorimeter is sensitive enough to reliably measure cold-induced~     thermogenesis as a surrogate marker of brown adipose tissue (BAT) activation.~      The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified~     using an IR imaging device, and that this IR energy output may be correlated to the~     increased energy expenditure quantified by the whole body calorimeter.~   "
20394|NCT02790242|"~     The purpose of this study is to gather information on patients who have heart failure and~     are eligible for one of the following two procedures: 1) mechanical support, i.e.~     ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which~     patient populations benefit from heart transplant or ventricular assist device. This will~     allow to offer the state-of-the-art care to the patients in heart failure.~   "
20395|NCT02790229|"~     The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®)~     compared to a standard rehabilitation protocol in patients with tibial plateau or ankle~     fractures with six weeks of partial weight bearing.~   "
20396|NCT02790216|"~     Objective:~      To focus the high dose radiation to the gross tumor in the prostate while maintaining~     adequate dose for control of microscopic disease elsewhere in the prostate.~      In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the~     clinical setting the investigators planned a study of Focused therapy with a primary~     endpoint of accurate localization of the high risk region. This is a pilot study of dose~     painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk~     region using multi-parametric MRI and deformable TRUS registration. The high risk region~     will be dose painted to 160 Gy and the rest of the prostate will receive the normal~     prescription dose.~   "
20397|NCT02790203|"~     Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after~     elective colonic resection.~   "
20398|NCT02790190|"~     This is a perspective, multicenter,randomized controlled trial to compare the efficacy and~     safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in~     patients with locally advanced non small cell lung cancer . Analyses of overall survival~     (OS) will be done as defined in the protocol.~   "
20399|NCT02790177|"~     The objective of study is to determine the effect of hyaluronic acid on the formation of~     post-operative adhesions. It will be a randomized control trial comparing the product~     against normal saline.~   "
20400|NCT02790164|"~     The main purpose of this study is to test the hypothesis that continuous NMB could improve~     outcome in cardiac arrest patients treated with therapeutic hypothermia.~   "
20401|NCT02790151|"~     Memory deficits after brain damage are common and there is still a need for evaluated~     therapy methods. In this study we compare two therapeutic interventions and investigate~     whether therapy effects can be found on neuropsychological tests and on a test measuring~     memory in everyday life.~   "
20402|NCT02790138|"~     The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous~     (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative~     colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous~     antibiotic treatment.~   "
20410|NCT02790034|"~     This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing~     respiratory abnormalities in Rett Syndrome. A third of equally randomised patients in to~     will be treated with 5 mg BID, another third with 10 mg BID and the remaining third with~     placebo BID over a course of 24 weeks.~   "
20411|NCT02790021|"~     Rationale: Breast cancer-related lymphedema (BCRL) is one of the most underestimated~     complications of breast cancer treatment with a reported incidence of 30% to 40% after~     axillary lymph node dissection (ALND) and 7% after sentinel lymph node biopsy (SLNB).~     Although the axillary treatment regimens are changing with a focus on less aggressive~     axillary treatment in order to reduce morbidity without compromising survival, BCRL will~     still remain a relevant problem in the future.~      Objective: To improve breast cancer survivorship by reducing/eliminating one of the most~     debilitating upper-body morbidities related to breast cancer treatment: chronic lymphedema~     of the arm.~      Study design: A multicenter, randomized controlled trial (RCT) carried out in the Maastricht~     University Medical Center, VieCuri Medical Center and Zuyderland Medical Center in the~     Netherlands.~      Study population: The study population includes all women over 18 years old who underwent~     surgical treatment for early stage breast cancer with an SLNB or ALND, or who received~     axillary radiotherapy, presenting with an early stage lymphedema of the arm (stage 1 and 2a~     on the ISL classification for lymphedema).~      Intervention: In this RCT patients are randomized over two arms: the first group will~     continue standard of care conservative lymphedema therapy, while the second group will~     undergo lymphaticovenous anastomoses (LVA) by a plastic surgeon.~      Main study parameters/endpoints: The main study parameters are the difference in excess limb~     volume (ELV) after one of both treatments, the effect of treatment on the quality of life~     and the cost-effectiveness of both treatments.~      Study-specific procedures: After randomization the follow-up moments will be at 3, 6, 9, 12,~     18 and 24 months. A follow-up moment includes an interview and a medical examination. During~     this examination, the upper limbs will be assessed for sensory, motor, strength and mobility~     changes. Furthermore, the investigators will measure the volume of the treated and untreated~     side using the water displacement method and circumference measurement. A lymphoscintigraphy~     is made at inclusion, after 12 months and after 24 months. Lastly, the subjects will be~     asked at certain time points to fill in five questionnaires: Lymph-ICF, EORTC QLQ-C30, EORTC~     QLQ-BR23, EQ-5D-5L and the DASH questionnaire.~   "
20412|NCT02790008|"~     Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy,~     dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting~     time for operation and postoperative exercise training is presently unknown.~      The investigators aim to (1) determine the changes in LVF for patients on the waiting list;~     (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to~     fibrosis and physical capacity.~      The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic~     resonance tomography and myocardial biopsy on the same patients) makes it possible to~     establish relationship between results of histology and imaging; quantifying and qualifying~     fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care~     prior to and after operation.~   "
20413|NCT02789995|"~     Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness~     (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning~     from mechanical ventilation and with long-term functional. Several mechanisms have been~     incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well~     investigated in this context, even though its involvement is suggested by the protracted~     functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be~     impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the~     post-injury muscle recovery.~   "
20414|NCT02789982|"~     The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade~     as a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing~     this new treatment on a large scale in a short delay. This clinical trial as been set up in~     response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance~     Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared~     to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to~     measure effectiveness and cost-effectiveness, socioeconomic measures, quality of life and~     social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12~     months after study enrollment.~   "
20415|NCT02789969|"~     Every year over 1,000 children undergo eye muscle surgery provided by physicians at this~     institution. For many of these children this is not and will not be the only surgical~     procedure for eye muscle correction. All of these children will experience differing degrees~     of postoperative pain. The pain associated with strabismus surgery is due to the~     manipulation in the conjunctival area and further handling of Tenon's capsule, sclera and~     the stretching of the eye muscle . Research has demonstrated that repeated painful~     procedures result in increased anxiety and increased pain.~      Previous studies have demonstrated that children experiencing preoperative anxiety are more~     likely to have increased postoperative pain . This increased preoperative anxiety may also~     contribute to sleep difficulties and increased analgesic consumption. Depending on the age~     of the child, different methods are used to reduce anxiety such as distraction, child life~     services, or anti-anxiolytic agents.~      In addition to pain, children undergoing strabismus surgery frequently experience~     postoperative nausea and vomiting (PONV).This increased incidence of nausea and vomiting is~     thought to be related to the use of opiates for pain control. Short acting opiates are used~     preferentially at this hospital in the belief that this reduces recovery issues of sedation~     and PONV. Preliminary data, however, suggests no difference in recovery outcomes for~     fentanyl versus hydromorphone. The purpose of this study is to investigate the optimal~     analgesia to create a standardized approach for pain management in pediatric patients~     undergoing surgery for strabismus.~   "
20416|NCT02789956|"~     The aim of this study is to evaluate:~      Primary objective The primary objective of the present study is to evaluate the marginal~     bone level changes when partially edentulous patients, treated with implants, received a~     multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an~     Internal or External connection.~      Secondary objective~        1. Overall survival rate.~        2. Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth~          (PPD) at baseline and after 1,3,5 years.~        3. Prosthetic survival rates including screw or abutment loosening, framework or veneer~          fractures.~   "
20417|NCT02789943|"~     Integrated and cross-disciplinary analysis of human physiology and disease provides unbiased~     and deeply informative insights into human health and disease. In this study the~     investigators will recruit patients undergoing coronary artery bypass surgery to study the~     atrium of the heart or the aortic wall that when diseased can cause strokes.~      Hypothesis: Systems-level analysis of the left atrium and aorta cells that integrates~     imaging, histological, cellular and molecular data will identify new mechanism for~     cardiovascular form and function.~   "
20418|NCT02789930|"~     The purpose of this prospective single center study is to investigate if a developed program~     is more accurate than the anesthesia tape (Anästhesie-Lineal). For this study 1000~     patients are required to collect anonymized data (length, weight, age, anesthesia material~     used during anesthesia) for achieving a power of 80% during statistical analysis. The main~     hypothesis ist that the program has a better accuracy than the anesthesia tape~     (Anästhesie-Lineal).~   "
20419|NCT02789917|"~     It is hypothesised that a dual therapy strategy by oral anticoagulation with the new~     Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with~     phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding~     bleeding events in patients with atrial fibrillation undergoing percutaneous coronary~     intervention in the setting of an acute coronary syndrome.~   "
20420|NCT02789904|"~     Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to~     6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and~     gender. A health economics and outcome model will be applied using the optimal high~     sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and~     outcome benefits predicted from optimal utilization of hsTnI.~      A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus~     high sensitivity troponin T (hsTnT) for all patients who present to the emergency department~     and require a blood draw. The outcomes of these patients will be tracked over the study~     period.~      The purpose of conducting this study evaluation is:~        1. To shorten the chest pain protocol for suitable patients to < 3 hours compared to the~          current 6 hours protocol with the latest high sensitivity Troponin I assays.~        2. To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS~          AccuTnI+3 with an accelerated algorithm in comparison to the standard of care acute~          coronary syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to~          rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room~          (ER) with isolated suspected ACS.~        3. To establish the local reference norms for hsTnI assays.~   "
20421|NCT02789891|"~     The purpose of this study is to explore the short-term, long-term and oncological outcomes~     of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.~   "
20422|NCT02789878|"~     This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen~     deprivation therapy with goserelin and abiraterone with or without apalutamide prior to~     radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.~   "
20423|NCT02789865|"~     Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for~     the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute~     appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic~     endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute~     appendicitis, the procedures to relieve the appendiceal lumen obstruction including~     appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever~     necessary will be carried out. In this multicenter prospective randomized clinical trial,~     the patients with uncomplicated acute appendicitis will be divided into three groups~     randomly: ERAT group, antibiotic therapy group and appendectomy group. The primary outcome~     is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean~     operative time, duration of fever, duration of leukocytosis, bed time, rate of complication,~     rate of recurrence and rate of appendectomy during follow-up period of 1 year.~   "
20424|NCT02789852|"~     Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the~     dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control~     group.~   "
20425|NCT02789839|"~     Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species~     or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including~     kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in~     quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce~     DNA damage that may lead to the destruction of the cell.~      The level of ROS in cells is the result of production (mainly the NADPHoxydase and the~     mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology~     team of the university hospital of Tours (France) found that certain antioxidant enzymes are~     essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3~     (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological~     diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).~      Age potentially affects the level of expression of antioxidant genes, since it was~     established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J~     Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of~     age on the oxidative metabolism of normal hematopoietic cells, and in particular the~     expression of antioxidant genes. It will provide a reference for analyzing disturbances of~     oxidative metabolism in blood diseases. The main objective is the comparison of peripheral~     blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years,~     40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major~     antioxidant enzymes involved in the regulation of oxidative stress will be studied. The~     secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a~     cDNA library (blood and marrow) from healthy volunteers.~   "
20426|NCT02789826|"~     The aim of surgical procedures for resection of cancer stomach is to resection of the tumor~     mass with safety margin and its drainage lymph nodes (lymphadenectomy).~      There are two main types of techniques (open & laparoscopic) Many studies were done~     comparing these two techniques showed that Laparoscopic resection is superior in early~     postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical~     than open resection (less safety margin & less lymphadenectomy) but because of the ongoing~     advances on laparoscopic surgery these results needs more and more revision.~      So the investigators conduct this randomized controlled trial aiming at comparing open and~     laparoscopic resection of cancer stomach to choose the best surgical procedure for resection~     of cancer stomach.~   "
20427|NCT02789813|"~     The purpose of this study is to evaluate whether valproic acid in combination with fear~     memory reactivation is useful to enhance treatment stability of exposure therapy for~     specific phobia.~   "
20452|NCT02789488|"~     Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive~     age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels.~     The genetically determined cause of the PCOS includes disturbed levels of insulin and~     androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as~     saponins & flavonoids which act on the insulin and indirectly helps to regulate the androgen~     levels in the body.~   "
20453|NCT02789475|"~     An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of~     amlodipine and rosuvastatin in healthy adult male subjects.~   "
20428|NCT02789800|"~     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is~     to reorient the health care system from a single disease focus to a multimorbidity focus;~     centre on not only disease but also the patient in context; and realign the health care~     system from separate silos to coordinated collaborations in care. PACE in MM will propose~     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be~     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),~     that are linked to Primary Care (PC) reform efforts. The study will build on this firm~     foundation, will design and test promising innovations and will achieve transformation by~     creating structures to sustain relationships among researchers, decision-makers,~     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is~     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces:~     British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to~     identify factors responsible for success or failure of current CDPM programs linked to the~     PC reform, by conducting a realist synthesis of their quantitative and qualitative~     evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning~     them to promising interventions on patient-centred care for multimorbidity patients, and to~     test these new innovations' in at least two jurisdictions and compare among jurisdictions;~     and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in~     Objective 2, and to conduct research on different approaches to scaling-up. This~     registration for Clinical Trials only pertains to Objective 2 of the study.~   "
20429|NCT02789787|"~     Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or~     underbites following early cleft repair surgeries. This clinical trial compares the current~     standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after~     pubertal growth (16-21 years), with an alternative orthopedic approach to protract the~     maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early~     adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative~     non-surgical approach to correct the malocclusion called maxillary protraction. Prior to~     age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly~     expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper~     jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective~     parallel cohort study will assess the patients undergoing treatment for the Cl III~     malocclusion by either orthognathic surgery or maxillary protraction at four data collection~     time points during treatment. The data includes digitized study models, photographs and~     radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost,~     periodontal measurements and treatment complications. The study design is a descriptive~     cohort study that examines the success of treatment (% not requiring a second surgery), the~     dental and skeletal changes associated with treatment, the stability of treatment and the~     behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each~     treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a~     pilot study to confirm translation to different settings will be conducted at Seattle~     Children's Hospital.~   "
20430|NCT02789774|"~     A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and~     Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a~     rigid collar. Follow up will be performed up to one year after start of treatment~     registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up.~     All direct and indirect costs of treatment will be registered and used for~     cost-effectiveness analysis.~   "
20431|NCT02789761|"~     A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33~     healthy males to investigate the vascular and cognitive effects of bi-daily consumption of~     high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects~     visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning,~     end and post-intervention.~   "
20432|NCT02789748|"~     This study aims at quantifying the performance of kinesthetic stimulation to reduce the~     burden of obstructive sleep apneas and hypopneas.~   "
20433|NCT02789735|"~     Persistent pregnancy-related pelvic girdle pain is common, 2-5% av all women given birth is~     suffering from disabling daily pain with high impact on quality of life.~      A prospective double-blinded randomised controlled trial will be performed with a baseline~     assessment 7-10 months after childbirth with follow-up directly and 6 months after a~     treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12~     planned treatment sessions during four weeks. 60 women will be included in the study.~      If LLLT can reduce pain and improve function there will be a new treatment option for this~     condition.~   "
20434|NCT02789722|"~     Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America~     highly consumed in this region. Different traditional products (mate, mate tea, chimarrao,~     tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Mate is a rich~     source of bioactive phenolic compounds, mainly caffeoylquinic acids. The richness of~     different mono- and dicaffeoylquinic acids is a peculiarity of mate derived products.~     However, in contrast to other plant-based beverages rich in polyphenols like tea or coffee,~     the research and the industry have yet little explored the potential interest of mate~     product to promote human health. There has been a growing interest to the development of~     healthier foods to face the burden of cardiovascular diseases (CVD), especially those~     naturally rich in bioactive phenolic compounds with protective effects against the~     development of chronic diseases. Different in vitro and animals studies associate the mate~     consumption with cardiovascular protection mechanisms. Consistent information about this~     activity and the long-term consumption effects in humans are scarce. The aim of this study~     is to assess through a randomized controlled trial the impact of chronic intake of mate on~     intermediate biomarkers of cardiovascular health in humans and to identify possible involved~     nutrigenomic mechanisms.~   "
20520|NCT02788604|"~     In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of~     childhood cancer and its aggressive treatment can have devastating psychosocial effects on~     the whole family (e.g. unpleasant feelings or emotions that impact your daily activities).~     It is not known whether health care providers who treat these children use and value~     psychosocial tools or how beneficial the use of these tools is for these families. This~     research team will test the benefits of using psychosocial screening on the quality of life~     of treated children, parents and siblings.~   "
20435|NCT02789709|"~     Predictive biomarkers are needed to identify those patients with higher risk of recurrence~     after surgery for colon cancer with curative intent. Our main objective is to determine a~     metabolite profile in blood plasma from patients operated from colorectal cancer that can be~     associated with the oncologic outcome and be validated as predictive biomarkers in future~     studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell~     lines treated with plasma samples from the same patients. In particular, to validate the~     increased utilization of lactate by tumor cells as a metabolic substrate using postoperative~     human samples.~      Patients with colorectal cancer that have undergone surgical resection will be included.~     Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and~     18th months after surgery. Metabolic profiles in plasma samples will be determined using a~     kit that allows the quantification of 180 metabolites by mass spectrometry.~      A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.~   "
20436|NCT02789696|"~     Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that~     comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with~     acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly~     gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the~     association are based on maxillofacial modifications linked to acromegaly, a thickening of~     soft tissues with deposits of glyco-aminoglycanes but probably also because of the~     associated obesity, of the potential existence of a goiter and a muscular dystrophy of the~     dilatative muscles of the pharynx.~      At present, no study clearly documented prevalence of acromegaly in a diagnostic~     consultation for sleep apnea syndrome.~   "
20437|NCT02789683|"~     The aim of this study is to compare the effects of emulsification and lipid droplet size on~     gastric emptying rate, and to determine if the change in gastric emptying rate can in turn~     influence postprandial glycemic, insulinemic and lipidemic responses.~   "
20438|NCT02789670|"~     New therapeutic approaches of MS are emerging, targeting different actors of the immune~     system. Some of them target a specific population of white blood cells: B lymphocytes~     composed of different subpopulations. The subsets of B cells express different functional~     properties that control the immune response, but these regulation mechanisms have yet to be~     clearly described. Some subpopulations could amplify inflammation through IL-6 production~     for example, whereas some ones contribute to its regulation through the production of IL-10.~     Using samples collected in a large cohort of individuals with risk of MS and treatment-naive~     patients in the early onset of the disease, the investigators aim to develop a 2 year~     follow-up study of the different blood B cells subset distribution and their functional~     properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach~     can identify new biomarkers for monitoring of MS patients and lead to better define the~     indication use of depletive B cell drugs and not to counteract the regulatory action of~     these cells.~   "
20439|NCT02789657|"~     Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or~     have spread to lymph nodes or both. The primary goal of this treatment is to prevent the~     cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the~     breast and lymph nodes shrink it might be easier to remove. This could allow a patient to~     have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the~     surgeon has to remove. In some cases, the neoadjuvant therapy works so well that it kills~     all of the cancer in the breast and lymph nodes. This is referred to as a pathologic~     complete response (pCR). Patients who achieve a pCR have a much lower risk of the cancer~     recurring elsewhere in their bodies.~      Investigators aren't sure which chemotherapy drugs work best with the HER2-targeted drugs,~     and what combination of these drugs causes the fewest side effects.Thus, this study has two~     main goals:~        1. To find out if treatment with wPCbTP, weekly paclitaxel and carboplatin given with~          trastuzumab and pertuzumab every 3 weeks, leads to as many pCRs as TCHP in patients~          with HER2-positive breast cancer, but has fewer side effects.~        2. To find out if HER2-positive patients whose cancers are not responding well after 12~          weeks of wPCbTP get a better response when they are switched to a~          doxorubicin-containing regimen called AC for 4 cycles (8-12 weeks).~   "
20440|NCT02789644|"~     A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy~     elderly subject after ursodeoxycholic acid administration~   "
20441|NCT02789631|"~     Several factors have been associated with neck pain. Controversy exists regarding the degree~     of association between some of these factors and neck pain. Information regarding the degree~     of association of each factor to neck pain is needed for effective prevention and~     appropriate treatment strategies. The aim of this study is to investigate the association~     among musculoskeletal, sensorimotor factors and functional disability and occurrence of~     chronic nonspecific neck pain.~   "
20442|NCT02789618|"~     Subjects with at least two teeth with dentinal hypersensitivity and who meet the study~     criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical~     trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash~     out period). Baseline dentine hypersensitivity assessments will be conducted using tactile~     stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the~     Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted~     using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP)~     questionnaire will be completed at four defined time points during the study. The baseline~     assessments will be conducted on the two teeth identified during the screening visit.~      On completion of the baseline assessments, subjects will be randomly assigned to product.~     Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product~     use.~   "
20443|NCT02789605|"~     Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and~     painful oral ulcers with unknown pathophysiology. Recent studies suggest that a~     dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are~     limited by severe side effects or inconstant effectiveness. The aim of this study is to~     assess the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in~     the treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects~     with RAS. Treatment consisted on the administration of the daily probiotics or placebo~     during 3 months.All patients will be then followed up for additional 3months without~     treatment. The main outcome measure will be the number of occurring aphtae.~   "
20445|NCT02789579|"~     Minimally invasive upper tract lithotomy is currently a common operation method on treatment~     of urinary tract stones, but the postoperative complication urinary tract infection or~     urinary sepsis has turned into a serious threat to the patient's life, when severe, can~     result in a higher death rate.Although more the more importance were attached to, an~     effective prevention measures still have not been found.~      Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of~     postoperative urinary tract infection. The conventional postoperative prophylaxis medicine~     was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown~     that continuous preoperative one week use of nitrofurantoin can significantly reduce the~     incidence of urinary sepsis. So the investigators assume that preoperative extended use time~     of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary~     sepsis.~      This study uses a computerized random method. According to preoperative use of different~     antimicrobial drug or treatment, all patients are randomly divided into three groups, namely~     levofloxacin group, nitrofurantoin group and control group.The levofloxacin group receives~     levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg,~     tid, po.to explore the better antibiotics types, medication timing and duration of treatment~     to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to~     reduce the incidence of postoperative urinary tract infection or sepsis.~   "
20446|NCT02789566|"~     The primary objective of this study is to provide a description of the pharmacokinetic~     properties of primaquine and metabolites and characterize these in healthy obese Thai~     subjects.~      This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal,~     subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.~   "
20447|NCT02789553|"~     Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has~     been associated with the onset of hyperglycemic peaks, which are very intensive and~     transient, in formally non diabetic patients. The aim of this study is to study the~     digestion of starch as compared to that of glucose (same glucose load) before and after~     gastric bypass surgery in obese patients.~      Volunteers will be recruited among the candidates to a gastric bypass, and will be studied~     before and 3 months after surgery. They will have on each occasion 2 random meals,~     corresponding to 30g glucose, one made of starch the other made of glucose, both naturally~     labeled with 13C. The digestion of starch will be assessed with the increase in the plasma~     13C-glucose tracer. Plasma samples will be collected for 3 hours.~      Some studies have already investigated time of absorption of glucose, but any study has~     examined the time of digestion of glucose. Other study always used glucose syrup, so they~     cannot have results about digestion. It is the reason why, in this study, glucose syrup and~     a starch meal will be taken by the same patient and glycaemia will be compared. In this way,~     results will be obtained about the kinetic of digestion of starch.~   "
20448|NCT02789540|"~     This is a multi-country, multicentre, observational prospective data collection cross~     sectional study of patients with stable COPD in Latin America. Primary objective is to~     assess and characterize COPD symptoms over a period of 24 hours, by collecting information~     about the respiratory symptoms experienced at different times of the day and night-time in~     patients with stable COPD under real clinical practice conditions. Correlation between each~     of these symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD)~     classification, adherence to respiratory treatment, level of dyspnea, disease severity,~     comorbidities and physical activity as well direct costs will be done as secondary~     objectives. Study population are patients of 40 years and older, smokers or ex smokers of >=~     10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in~     Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is~     targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical~     power to primary objective.~   "
20449|NCT02789527|"~     Physicians know that their patients can react differently to the same medical treatment: for~     some of them, the drug will prove inefficient, whereas for others it might provoke~     side-effects, sometimes rather serious. Such differences in response to drug intake are due~     to several factors, of which molecular variations in specific genes, named  ADME ~     (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the~     evolutionary mechanisms responsible for the diversity of ADME genes in human populations.~     Because of their role at the interface between the organism and its chemical environment,~     ADME genes are likely targets of recent selective pressures linked to changes in the~     environments in which humans evolved, such as changes in dietary habits for instance.~      The aim of this project is to study the diversity of ADME genes and of their expression in~     five populations located along a latitudinal axis that extends from East Africa to Central~     Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into~     account environmental factors that might have influenced the evolution of this diversity.~     This project is thus intended to evidence the evolutionary mechanisms that shaped genomic~     regions that are functionally important from the clinical and epidemiological point of view.~     Moreover, it will allow us to extend the knowledge of human molecular diversity and its~     evolution to a key-region of the peopling history of our species.~   "
20450|NCT02789514|"~     Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology~     diseases. The investigators want to find which symptoms can support for positive endoscopic~     findings.~   "
20451|NCT02789501|"~     Catheter infections and dysfunctions are a major cause of morbidity and mortality in~     haemodialysis patients. According to the US Renal Data System, infection is the second~     leading cause of death in dialysis patients and the leading cause of catheter removal and~     morbidity in patients with end-stage renal disease.~      There is evidence that catheter lock solutions containing taurolidine reduce the risk of~     catheter related infections and improve catheter patency. Lock solutions have a local, but~     no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500,~     Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm,~     Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL,~     Montreal, Canada, 3x/week) as standard lock solution.~      The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled~     haemodialysis catheters has reducing effects on catheter related blood stream infections and~     catheter dysfunctions.~   "
20454|NCT02789462|"~     This is a multi-center, investigator initiated study that will prospectively and~     retrospectively examine treatment strategies and outcomes of patients who underwent~     percutaneous coronary interventions (PCI).~      The goal of this multi-center, investigator initiated, registry is to collect information on~     treatment strategies and outcomes of consecutive patients undergoing laser-assisted PCI~     among various participating centers. The study is a purely observational, chart review study~     and involves retrieval and compiling of data based on clinically indicated procedures and~     follow-up clinical and procedural outcomes.~      The information collected will be used to determine the frequency of laser-assisted PCI~     performed at the participating sites and examine the procedural strategies utilized, and the~     procedural (both immediate and subsequent) outcomes.~   "
20455|NCT02789449|"~     The aim of the study is to investigate the role of the non-invasive assessment of nitric~     oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of~     pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon~     monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and~     postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO~     has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease~     may more specifically identify the limiting factors between the alveolar space and the lung~     capillaries including left heart failure (cardiac edema).~      As there are no available published data yet to answer this question investigators aim to~     perform a small pilot study. The results of this study may allow the planning of a~     prospective study.~   "
20456|NCT02789436|"~     The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges~     (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.~   "
20457|NCT02789423|"~     The purpose of this study was clinical and radiographical evaluation of the effect of~     calcium hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp~     capping in primary teeth.~   "
20458|NCT02789410|"~     Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal~     anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used~     but the use of IT hydromorphone is growing. A previous study has shown that the effective~     dose for postoperative analgesia in 90% patients (ED90) for both IT hydromorphone and IT~     morphine (NCT02009722). These doses were found to be 75 mcg for hydromorphone and 150 mcg~     for morphine. The current proposed study would compare the duration of analgesia of IT~     morphine vs IT hydromorphone after elective cesarean delivery. Additionally, the~     investigators will compare each drug with respect the incidence of nausea and pruritus.~   "
20459|NCT02789397|"~     This phase II study will assess the effect of a treatment combination of Rituximab and~     azathioprine in patients with Granulomatous and Lymphocytic Interstitial Lung Disease~     (GLILD) compared to placebo, based on change in lung function at 18 months compared to~     baseline. The researchers will also assess if the drugs improved quality of life.~   "
20460|NCT02789384|"~     This is a prospective observational biomarker study including patients with non-metastatic,~     soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best~     option by the multidisciplinary sarcoma team of one of the participating centers.~   "
20461|NCT02789371|"~     The purpose of this study is to compare the diagnosis accuracy of modified wet suction~     technique and 5ml dry suction technique on solid occupying lesions.~   "
20462|NCT02789358|"~     This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary~     vein ablation procedures in patients with paroxysmal atrial fibrillation.~   "
20463|NCT02789345|"~     The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in~     combination with osimertinib in participants with non-small cell lung cancer (NSCLC).~   "
20464|NCT02789332|"~     This is a multicenter, prospective, randomized, open-label phase II study evaluating the~     efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced~     breast cancer in patients with HR deficiency. Patients will be randomized to receive~        -  paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg (4X25mg)~          twice daily for 12 weeks (65 patients) or~        -  paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12~          weeks (37 patients) both followed by 4 cycles of epirubicin 90 mg/m² and~          cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.~      The control arm was chosen to allow direct comparison with one of the currently considered~     standard of care regimen.~   "
20465|NCT02789319|"~     The blanket protocol covers the execution of the Diabetes Technology Society (DTS) Blood~     Glucose Monitor System Surveillance Program that will consist of a series of similar~     accuracy sub-studies with marketed Blood Glucose Monitor Systems (BGMS) conducted by the~     Clinical and Laboratory site(s) chosen for this study. The two parts of the study (BGMS~     testing and comparative glucose analyzer testing) will be conducted in separate facilities~     (clinical site and laboratory site) so the clinical and laboratory investigators will be~     blinded from each other's results.~      To access the full protocol:~     http://dst.sagepub.com/content/early/2015/12/10/1932296815614587.full.pdf+html~      The clinical site(s) will recruit subjects and test their fingerstick blood directly on the~     Blood Glucose Monitor Systems. Tubes of fingerstick blood will also be collected from the~     same subjects, centrifuged and the plasma collected and frozen for shipment to a Clinical~     Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) certified,~     accredited clinical chemistry laboratory for measurement on a comparative glucose analyzer.~     In addition, National Institute of Standards and Technology (NIST) glucose standards (965b)~     will be assayed on the comparative glucose analyzers to determine any bias from the true~     glucose values established by the reference mass spectrometry method.~      This series of sub-studies will assess the accuracy of various BGMSs by trained~     professionals, not by the intended end user. Only accuracy of the BGMSs when tests are~     performed by trained study staff will be assessed. Understanding by the end user of~     instructions for use (labeling) and human factors analysis are not within the scope of this~     protocol.~   "
20522|NCT02788578|"~     The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG)~     combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive~     neuroendocrine tumours located in the lung or in the digestive system as there is currently~     limited data on these treatments used together for these types of neuroendocrine tumours.~   "
20466|NCT02789306|"~     In the field of periodontics, periodontal support therapy has proven to be essential in~     preventing the incidence or recurrence of periodontal diseases. The protocol is designed~     according to the risk profile of a patient. For example, in the presence of the history of~     periodontal therapy, subgingival microbiota containing large numbers of spirochetes and~     mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance~     of dental implants has been recommended to prudently avoid peri-implant inflammation,~     Indeed, the understanding of the nature of the tissue around the implant and its pattern of~     disease would be important to consider, even surpassing importance. Recently, a systematic~     review by our group has identified the importance of maintenance therapy around implants~     because it can help prevent about 3 times patient-level frequency peri-implantitis.~      Henceforth, our primary goal was to study the influence in a cross-sectional study of the~     frequency of peri-implantitis patients according to their post-implant placement and~     corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be~     shown:~        1. What are the local and systemic factors affecting the appearance of peri-implantitis~        2. The ideal frequency of supportive peri-implant maintenance in patients who do not~          develop peri-implant disease~        3. What is the population of patients who come to supportive peri-implant maintenance~          after placement of dental implants~   "
20467|NCT02789293|"~     The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound~     treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.~   "
20468|NCT02789280|"~     The main goal of this study was to compare the effect of a one-session unsupported Internet~     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and~     related variables (mood, confidence and motivation).~   "
20469|NCT02789267|"~     Undernutrition in cancerology is frequent because it's present for thirty to fifty percent~     of the patients at the time of the diagnosis. According to the recommendations of the French~     Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five~     percent loss of weight compared to the previous weight increases the risk of toxicity of the~     chemotherapy and worsens the patient's quality of life.~      The treatment of the tumors of the head and the neck comes along very often with a loss of~     weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.)~     which varies with the chosen treatment, and shows a major risk at the patients whose~     therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive~     tract is source of aftereffects and late complications: xerostomia, oedemas of mucous~     membranes.~      The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of~     the patients. It reveals or even increases, a dysphagia. According to Woisard, six months~     after the end of treatments, forty percent of the patients suffer from a dysphagia.~      All these complications limit quantitatively and qualitatively the food intake. The~     adaptation of the texture of the food is necessary by fifty four percent at three months of~     the end of treatments according to Logemann et al., and a few patients remain dependent on~     an long term enteral nutrition.~      Beyond a change of the nutritional state, the feeding difficulties or even the absence of~     resumption of an oral feeding are responsible for a social isolation. The meal which lost~     its dimension of pleasure becomes a source of fear and obsession for the patient as well as~     for his relations, and this fact generates family tensions. The quality of life of the~     patient is heavily affected.~      Ravasco showed in his study that the impact on the nutritional state of a nutritional care~     by dietary advices was more important as the prescription of oral nutritional supplements~     but based on a short period (the dietary intervention covered only the duration of the~     radiotherapy). But what would happen after the end of treatments? The investigators emit the~     hypothesis that a post-therapeutic systematic and regular dietary support has a positive~     impact on the prevention of the undernutrition among the patients affected by a first cancer~     of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.~   "
20470|NCT02789254|"~     This is a first in human, prospective, monocentric, nonrandomized, open-label study to~     investigate the safety, tolerability, preliminary efficacy, pharmacokinetics,~     pharmacodynamics and immunogenicity of repeat doses of the Fc-optimized antibody FLYSYN as~     monotherapy in adult subjects.~   "
20471|NCT02789241|"~     The purpose of this study is to evaluate 4-dose levels of CCRE Lot 94332B1 (0.6, 1.0, 2.0,~     and 4.0 ng/kg). This study is known as, an endotoxin challenge. Thousands of healthy~     subjects worldwide over the last 20 years have participated in endotoxin challenge studies~     as part of clinical research and clinical drug development programs. This study will only~     test the safety and tolerability of CCRE Lot 94332B1.~   "
20472|NCT02789228|"~     Patients with high-risk solid tumors, those that are refractory to standard up front therapy~     or relapse after completion of therapy, have a very poor prognosis despite attempts to~     induce remission with salvage regimen. Novel therapies are critical for this patient~     population with high-risk cancer.~      The ability of tumors to be recognized and lysed by the immune system offers a unique~     opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells.~     Through this ability to harness sophisticated and specific immunotherapy, residual or~     relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated.~     Prior studies have suggested both safety of expanded specific T cells and efficacy in the~     setting of melanoma, lymphoma or viral eradication. While this therapy has previously been~     limited by the versatility of the tumor to down-regulate antigens and evade a single~     immune-target, the use of multi-antigen specific T cells may permit better and more durable~     anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen~     anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be~     conducted to demonstrate safety of these cells and generate efficacy and biology data that~     may be important for future studies that may enhance tumor immunotherapy.~   "
20473|NCT02789215|"~     Child and Adult Care Food Program (CACFP) meals are an important influence on diets of~     children from low-income families enrolled in the CACFP and should meet children's nutrient~     needs while fostering healthy eating habits that enable them to maintain energy balance.~     Recent national data revealed that children consumed low intakes of foods that support~     healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high~     intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of~     Medicine (IOM) report for CACFP meals provided new recommendations that include new meal~     pattern requirements for the meals programs, aligning them with the U.S. Dietary Guidelines~     to ensure that the meals promote health and reduce inadequate and excessive intakes. The~     report recommended inclusion of more whole grains, fruit, vegetables, and meat/meat~     alternatives which will likely increase meal costs. Two of the IOM report recommendations~     call for research to better understand how the new meal requirements would change children's~     CACFP meal dietary intakes and food service costs. These are important questions, and~     answers are needed to inform policy and future technical and educational assistance needs.~     The overall objective of this project is to implement the IOM meal pattern requirements for~     CACFP meals in day homes and centers in Texas. The multidisciplinary team will focus on~     nutrition, economics, and provider outcomes. The specific aims are to assess the impact of~     the new meal pattern requirements on 1) Meal participation rates; 2) Provider food service~     costs (food, labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It~     is hypothesized that, compared with control sites, intervention site children will select~     and consume healthier diets (more fruit, vegetables and whole grains) at school. A total of~     32 day care sites will be recruited for the study. It is hypothesized that, compared with~     control sites, children at the intervention sites will select and consume healthier diets~     (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the~     increase in food costs will be less than that projected in the IOM report. The results on~     the costs associated with creating the desired meals will be very important as these data~     have not been systematically collected in previous studies. This significant study targets~     underserved minority populations with health promoting intervention to reduce health~     disparities, and in addition, will inform policy on the influence of a healthy food~     environment on children's diet, as well as provide critical information on costs.~   "
20474|NCT02789202|"~     This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in~     arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides,~     the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this,~     100 babies 1-3 years will be examined and treated in a mobile dental unit, which will~     temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis~     will be conducted using the International Caries Detection and Assessment System (ICDAS).~     Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and~     Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6,~     12, 18 and 24 months. As primary outcome, caries progression into dentine will be~     considered. Acceptability reported by parents after treatments, the time and estimated money~     spent for treating will also be collected. Social and biological data that could be related~     to efficacy of techniques will be also collected. Multilevel analyses will be performed to~     check which technique will be most effective and possible factors associated to its~     efficacy. Discomfort, acceptability and costs will be compared between/among the approaches~     used to arrest enamel caries lesions.~   "
20475|NCT02789189|"~     The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and~     efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and~     metastatic nasopharyngeal carcinoma~   "
20476|NCT02789176|"~     The purpose of this study is to examine whether the duration of treatment with phenobarbital~     has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family~     well-being, after neonatal seizures.~   "
20477|NCT02789163|"~     Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held~     ultrasound and an automated breast volume scan. Exams were performed by different~     technologists. Images were blinded and blinded read for diagnostic accuracy of the two~     examinations~   "
20478|NCT02789150|"~     Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP~     of greater than or equal to 85mmhg~   "
20479|NCT02789137|"~     The purpose of this study is to know about the quality of life of patients with metastatic~     renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who~     suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore~     measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or~     cure such side effects that affect patients.~   "
20480|NCT02789124|"~     Difficulties in the accurate assessment of intravascular volume in critically ill patients~     are frequently encountered. In addition to clinical evaluation, bedside echocardiographic~     measurements of fluid responsiveness can be technically difficult, especially in critically~     ill mechanically ventilated patients. The carotid artery is an easily accessible structure~     that is amenable to bedside ultrasonography performed by Intensivists. The investigators~     hypothesize that measurement of the carotid artery Corrected Flow Time (FTC) in response to~     a passive leg raise (PLR), which simulates a fluid bolus, can be used to predict fluid~     responsiveness.~   "
20481|NCT02789111|"~     The Investigator has chosen to study the reconstructive spinal surgery patient population~     because it is believed that the use of alvimopan in these patients at the University of~     Virginia will give the scientific community significant insight into the broader~     applicability of this drug into other surgical populations, the impact of this drug on the~     perception of pain (as opposed to simply the consumption of opioids), and its impact on~     total hospital charges, resource utilization, and functional outcomes.~   "
20482|NCT02789098|"~     Left ventricular remodeling is a common complication in patients with ST-elevation~     myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and~     inflammatory mechanisms are involved in this pathophysiological process. Recent data~     demonstrated that remote, noninfarct-related region of the myocardium is also implicated.~     There is no data about the assessment of coronary endothelial function or myocardial~     fibrosis in the remote zone in patients with STEMI . The correlation between these~     parameters and left ventricular remodeling is not known.~   "
20483|NCT02789085|"~     Using computerized pupillometry, previous research established that the autonomic nervous~     system (ANS) is dysregulated in patients who suffer from temporomandibular disorders (TMDs),~     suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD.~     However, pain modulation hypotheses in TMD are still lacking.~      The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior~     and pain through μ, κ, and δ opioid receptors. Transcutaneous electric nerve stimulation~     (TENS) has been extensively used for pain relief, as low-frequency stimulation is able to~     activate µ receptors. The aim of the present study is to use ANS polygraph and~     salivary/serum biomarkers to evaluate the effect of low-frequency TENS stimulation of ANS in~     TMD patients.~      According to the Research Diagnostic Criteria for TMD, people with myogenous TMD and~     matched-controls will be enrolled. All subjects will be randomly assigned to control group~     (no tens stimulation) and case group (test stimulation); subsequently, ANS parameters by~     both biomarkers and ANS polygraph, before, soon after (end of stimulation), and late after~     (recovery period) sensorial TENS will be collected.~      The overall statistics will be performed from all conditions recorded comparing controls vs~     cases.~      The expected results consist in discovering ANS deregulation in TMD with and without TENS~     stimulation.~   "
20484|NCT02789072|"~     Cardiovascular events remain the main cause of death of the industrialized world (Global~     status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011).~     Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent~     the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease,~     cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial~     infarction and stroke.~      The main objective of this experiment is to investigate the differential effect of~     microgravity on central aortic blood pressure.~      The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that~     microgravity leads to an increased central aortic pressure.~   "
20521|NCT02788591|"~     Primary Objective:~      Evaluate response to NERD treatment between patients with normal endomicroscopy findings~     compared with patients with abnormal endomicroscopy findings.~      Secondary Objectives:~      To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating~     dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.~      Quality of life at study entry and end of study. Compare two medications under study within~     each group as a subgroup analysis.~   "
20485|NCT02789059|"~     Previous studies showed modifications of muscle oxygenation parameters in muscular~     dystrophies du to an impairment or an absence of dystrophin.~      Our study aim at assessing muscle oxygenation during effort in different neuromuscular~     diseases (muscular dystrophies related and not related to dystrophin, non dystrophic~     myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and~     controls are invited to perform an inframaximal , standardized effort of the knee extensors~     by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through~     a Near Infrared Spectroscopy (NIRS) Device.~      In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in~     order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.~      Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular~     dystrophies compared to other neuromuscular diseases and healthy controls because of lack of~     muscle capillary vessels dilatation during effort and impairment of mitochondrial function.~   "
20486|NCT02789046|"~     The objective of the prospective multicenter observational study consists in defining a~     difficult intravenous access score in adult, during the preoperative period.~      The main objective: the outcome of interest is defined as failure of cannulation on first~     attempt.~      The risk factors of failure of cannulation on first attempt will be described. Adjusted~     multivariate models will be constructed. A prediction model will be proposed according to~     the transparent reporting of a multivariable prediction model for individual prognosis or~     diagnosis (TRIPOD)~   "
20487|NCT02789033|"~     The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the~     condition is more frequent in elder patients. It is estimated that about 5% of all patients~     with diabetes present a history of foot ulceration, while the lifetime risk of diabetic~     patients developing this complication is 15%. The majority (60-80%) of foot ulcers will~     heal, while 10-15% of them will remain active, and 5-24% of them will finally lead to limb~     amputation within a period of 6-18 months after the first evaluation , 2 out of 3 patients~     with a limb amputation could also be involved in a new amputation in the next year; higher~     or in the other leg , Eighty-five percent of lower-limb amputations in patients with~     diabetes are preceded by foot ulceration. The management of chronic diabetic foot ulcers~     (DFU) suggests multi-disciplinary approaches including control of diabetes, orthotic shoe~     wear, off-loading device, wound care and surgery in selected cases. However, treatment of~     DFU remains challenging because of unsatisfactory results from surgical and non-surgical~     treatments. Many adjunctive therapies are designed to improve the care of DFU including~     negative pressure wound therapy , ultrasound, recombinant human platelet-derived growth~     factor-BB (rPDGF-BB) Hyperbaric oxygen and acellular matrix product among others.~   "
20488|NCT02789020|"~     Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to~     perform functions such as grooming, dressing, cooking, and other activities of daily living.~     PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that~     up to 9.3 million people will be affected by 2030. Although current pharmacological~     therapies provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and~     bradykinesia), intolerable disability eventually develops in most patients. A~     disease-modifying therapy that slows disease progression is a major unmet medical need in~     PD. Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none~     have been shown to have indisputable disease-modifying effects in clinical trials for~     patients with PD.~      The purpose of this research study is to investigate how the brain and motor behavior~     changes in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B)~     inhibitor. The drug rasagiline will be tested in this study as the MAO-B inhibitor.~     Rasagiline has been prescribed for many years to treat symptomatic Parkinson's disease. It~     is FDA approved for the treatment of Parkinson's disease but has not been shown to slow~     disease progression. The outcome and impact of this study will provide the first evaluation~     of MAO-B inhibitors at slowing the progression of the nigrostriatal pathway using advanced~     Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in~     PD.~   "
20489|NCT02789007|"~     The main objective of this experiment is to assess the impact of parabolic flight on (1)~     spatial memory and orientation, (2) the changes in brain structure and function, and~     particularly the hippocampal formation, and (3) biochemical markers of stress and~     neuroplasticity.~      A preliminary study will be performed with the aims (1) to test during weightlessness~     hardware used to administer visuo-spatial testing and (2) to determine the optimal body~     posture for testing under microgravity conditions (i.e. body posture for which change in~     visuo-spatial testing induced by weightlessness is maximal).~      The main criteria are:~        -  Structural and functional changes of brain evaluated by fMRI;~        -  Cognitive performance, and specifically spatial cognition using a series computer-based~          tasks.~        -  Key neurotrophins determined in venous blood samples The criteria used in the~          preliminary experiment is visuo-spatial performance evaluated with a computer-based~          test assessing spatial cognition.~      The investigators hypothesize that hippocampal structure and function, and particularly the~     dentate gyrus, will be altered after parabolic flight compared to ground based controls.~     Specifically, the 3 tested hypotheses are:~        -  Parabolic flight induces changes in hippocampal structure;~        -  Weightlessness induces changes in cognitive performance, and specifically spatial~          cognition;~        -  There is a correlation between changes in hippocampal structure and changes in~          visuo-spatial memory performance.~        -  There is a correlation between changes in hippocampal structure and changes in key~          neurotrophins.~      The hypothesis tested during the preliminary experiment is that body posture affects the~     changes in spatial cognition performance.~   "
20490|NCT02788994|"~     This is a preliminary study to establish the issues and potential of the investigators~     proposed project, which involves recruitment of patients with and without dementia, who have~     been admitted to hospital following hip fractures. The study will be evaluating the result~     of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is~     restored leading to their independence. These patients would require surgical fixation (not~     replacement) of their hip fractures.~      The study will evaluate two methods of fixation of hip fractures treated with either a pin~     (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate~     which is applied on the outer aspect of the thigh bone.~      The data collected from this study will provide information on whether one method of~     fixation is better than the other.~   "
20491|NCT02788981|"~     This is a randomized, placebo-controlled, double-blind, phase II trial of nab-paclitaxel~     with or without mifepristone for advanced, glucocorticoid receptor-positive, triple-negative~     breast cancer. A total of 64 patients will receive nab-paclitaxel. Patients will be randomly~     assigned to either receive placebo or to receive mifepristone daily on the day prior to and~     day of each dose of nab-paclitaxel. Patients will be enrolled over 12 months and followed~     for 12 months following completion of study.~      To expand and follow up on the investigators understanding of a potential PK interaction~     between nab-paclitaxel and mifepristone, investigators will perform PK studies in the first~     20 patients enrolled at pre-specified PK sites.~   "
20492|NCT02788968|"~     The study to explore the development of these abilities with age, and called Development of~     the conflict detection during the reasoning - Decor will take place at CYCERON center and~     will include two groups of 22 participants: adolescents and young adults (N = 44). More~     specifically, this study aims to compare the changes in the brain of adolescents and young~     adults when conducting reasoning tasks for which there may be a cognitive conflict. Both~     groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain~     and in which they will carry out two classic tasks covering the main areas of reasoning~     (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of~     making information call intuition to create or not a conflict between the correct answer~     (logic, normative) and biased response (intuitive, heuristic). Because of the major~     implication of this brain region in cognitive inhibition processes [of intuitive answer],~     measured brain activity in the anterior cingulate cortex (ACC) during both tasks version~     with or no conflict will be compared between groups. To better understand the links~     between the development of the CCA from adolescence to adulthood and conflict detection,~     activity measurements will be correlated with a part in morphometric measurements taken from~     the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly~     to cognitive measures (executive functions - inhibitory control). This cross-sectional study~     focused on two age groups: 11-15 years and 19-25 years. For each age group, the~     participation of men / boys and women / girls will be balanced up.~   "
20493|NCT02788955|"~     This is a feasibility study to test the efficacy of diets of different amounts of protein~     and calories for patients with cancer. We hypothesize that nutritional deficits play a~     significant role in muscle loss and that nutritional therapy is an important first step in~     reversing or preventing muscle loss and maintaining/improving physical function, tolerance~     to treatment and quality of life.~   "
20494|NCT02788942|"~     Laparoscopic cholecystectomy is gold standard for gallstones. In this study the~     investigators are investigating the effect of the removing of cholecystectomy material from~     different ports, to the port site infections.~   "
20495|NCT02788929|"~     Design: Single center, prospective, randomized study that will compare activity levels in~     patients who complete cardiac rehabilitation after clinically indicated percutaneous~     coronary intervention with and without use of the wrist-worn Fitbit Charge HR device and~     mobile platform application.~      Primary Endpoint: The average number of steps taken per day will serve as the main marker of~     daily physical activity.~      Control: Patients who do not receive the device (Fitbit Charge HR).~      Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity~     and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of~     moderate/vigorous physical activity (5) change in quality of life (6) change in indicators~     of depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9)~     change in BMI and waist circumference (10) change in resting heart rate and blood pressure~     (11) change in exercise stress test performance (timeframe for all: baseline - 12 weeks)~   "
20496|NCT02788916|"~     The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte~     (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World~     Health Organization (WHO) classification of lymphoid neoplasms.~   "
20497|NCT02788903|"~     The overarching goal of this proposal is to understand the comparative effectiveness of~     obesity counseling as covered by CMS in improving weight loss for adults either with or at~     high risk of type 2 diabetes. CMS and most insurers now include obesity screening and~     counseling benefits, with no cost sharing to patients. Since overweight patients are at~     highest risk for diabetes, improved weight management services could prevent diabetes and~     its negative health outcomes. Beneficiaries with obesity are eligible for up to 20~     face-to-face visits for weight counseling in the primary care setting. We propose comparing~     weight and diabetes outcomes in three states using EHR and claims data before and after this~     policy was implemented by leveraging the novel infrastructure of the Patient-Centered~     Outcomes Research Institute-funded PaTH Clinical Data Research Network.~   "
20498|NCT02788890|"~     The study will evaluate the vital signs changes during 3 different dental procedures~     performed for the same patient by the same dentist. The patients will be selected randomly~     and should all be healthy adults.~      The aim is to look for any significant changes in the major vital signs (heart rate,~     respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body~     temperature) during specified dental procedures (scaling, simple restoration, and simple~     exodontia) and compare the changes between the 3 procedures.~   "
20499|NCT02788877|"~     Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME)~     will be evaluated.~   "
20500|NCT02788864|"~     The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine +~     Piperaquine (DP) are effective in preventing malaria infection for forest ranger~   "
20501|NCT02788851|"~     The purpose of this project is to evaluate the effectiveness of a structured aerobic~     exercise intervention for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) with~     and without medication and compare it to medication alone. Participants will be randomly~     assigned to medication only + education, aerobic exercise intervention only, and combined~     aerobic exercise and medication groups. Participants will be evaluated at baseline,~     following medication optimization (for medicated groups), following 8 weeks of intervention,~     after 3 months of follow-up, and after 6 months of follow-up. The investigators hypothesize~     that the combined group will have the best outcome at all evaluation points and that~     treatment gains will be maintained throughout the follow-up period if the assigned~     treatments are continued.~   "
20561|NCT02788071|"~     The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will~     result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).~   "
20502|NCT02788838|"~     The purpose of this project is to examine the impact that television food advertisements~     have on brain responses and eating behavior in children. Food advertisements enhance~     children's liking and intake of foods that tend to be high in energy content and low in~     nutritional value. Although several studies have measured the differences in children's food~     intake after watching advertisements, none have shown the brain mechanisms associated with~     this change in behavior. In order to clarify the relationship between food advertising and~     eating behavior, the investigators have assembled a team with expertise in functional~     imaging, eating behaviors, and clinical pediatric research. First, the investigators will~     observe the differences in children's eating behaviors after being exposed to food~     commercials or non-food commercials. Second, the investigators will measure the difference~     in child brain response to high and low energy foods after being exposed to food commercials~     or non-food commercials. These data will allow us to identify which areas of the brain are~     specifically affected by exposure to food commercials and correlate activity in these areas~     with children's measured food intake in the laboratory. Forty children ages 7-9 will~     participate in this 5-visit study which will be completed over the course of 12 months.~     Understanding how food advertisements impact children's brain responses and subsequent~     eating behaviors will have implications for understanding why some children respond~     differently to these cues than others. These outcomes may also inform the development of~     more effective programs and policies to prevent childhood obesity.~   "
20503|NCT02788825|"~     Prostate cancer is a leading cause of cancer death among men in the Western world. Early~     detection of prostate cancer has been shown to decrease mortality, but has limitations with~     low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The~     STHLM3 trial has paved the way for improved specificity in early detection of prostate~     cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring~     significant prostate cancer.~      Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of~     high-grade cancers compared to the currently used systematic biopsies, but existing evidence~     are contradictory and not free from methodological flaws.~      The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of~     prostate cancer without decreasing the sensitivity of aggressive prostate cancers by~     introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The~     primary endpoints are the number of performed biopsies and the number of detected high-grade~     prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of~     low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded~     disease after assessment of prostatectomy specimen. Additional aims include to assess the~     health economic consequences of implementing MRI based prostate cancer diagnostics and to~     improve the quality and effectiveness of prostate cancer diagnosis in the routine health~     care in Stockholm.~      The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately.~     Based on power calculations, approximately 500 planned for prostate biopsies will be~     included in the first phase. Men who have previously been diagnosed with prostate cancer may~     not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The~     second phase will start in autumn 2016 and end by December 2017.~   "
20504|NCT02788812|"~     To determine if there is a difference in the quality of life in between patients who~     undergoes laparoscopic transabdominal pre-peritoneal (TAPP) or modified Lichtenstein~     hernioplasty~   "
20505|NCT02788799|"~     Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the~     criterion usually used in practice to identify patients with acute coronary artery occlusion~     and is essential for the direct and acute referral of patients for primary PCI. However, ECG~     does not always reflect changes in the posterior wall of the heart, often equivalent to the~     left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of~     LCX as culprit artery in STEMI populations. There is a general concern that some patients~     with genuine acute occlusion of LCX may present without ST segment elevation and be denied~     reperfusion therapy, resulting in larger infarction and worse outcome.~      The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in~     addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the~     clinical impact of this implementation: In comparison to a control cohort of STEMI patients~     diagnosed with a pre-hospital standard 12-lead ECG prior study start, the investigators~     hypothesize that introducing V7-V9 leads as a clinical routine in the pre-hospital setting~     will identify patients with STEMI involving LCX and with a non-diagnostic standard 12-lead~     ECG.~   "
20506|NCT02788786|"~     In Nepal, investigators are conducting a cohort study to estimate the relationship between~     signs of periodontal disease in pregnant women and preterm delivery. Within that cohort~     study, investigators plan to conduct an individually randomized trial of the acceptability~     and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival~     crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from~     a subset of the area currently engaged in the larger cohort study, to simplify logistics.~     The pilot trial will have four arms (three oral rinse arms, and one control group).~        -  Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with~          periodontitis~        -  Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women~          with/without periodontitis)~        -  Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without~          periodontitis)~        -  Arm 4: No oral rinse (n=50)~      To select and enroll these 175 participants, data collectors will use the information they~     collected during an oral health clinical examination conducted at the time of enrollment~     into the broader cohort study; this information will be used to classify women by signs of~     periodontitis.~      Those selected through this above process will be read an additional consent form; those~     agreeing to participate will be provided with a supply of their assigned rinse (and~     instructions on its use and handling/storage), or no rinse. Those in the three rinse groups~     will be asked to use the provided rinse twice per day after brushing and to save the empty~     bottles for collection by the health care worker. At the end of this first visit, women will~     additionally provide a venous blood sample to measure systemic inflammation markers and~     fluoride.~      Women receiving the rinse will be visited by study workers periodically to provide more oral~     rinse and check on their adherence to the rinse. All 175 women will be visited after 12~     weeks to undergo a second oral health clinical examination and provide a second set of~     gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each~     of the oral rinses as compared to the normal physiological changes in gingival inflammation~     and biofilm composition during the course of pregnancy.~      At this final visit, the women in the three rinse arms will also answer a short~     questionnaire to gather feedback on acceptability and adherence to the oral rinse.~   "
20507|NCT02788773|"~     The purpose of this study is to find out the effects of giving durvalumab alone or in~     combination with tremelimumab on this type of cancer. In addition, this study will look at~     the side effects of durvalumab when given alone or in combination with tremelimumab.~   "
20508|NCT02788760|"~     Most fractures of the cervical spine are considered stable and treated with a rigid cervical~     collar. However no studies have to date been published addressing the length of treatment.~     There seems to be a significant dissimilarity between hospitals within and between countries~     with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical~     department at Oslo University Hospital, Ullevål the standard length of treatment for a~     stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of~     collar treatment for a specific subtype of stable fractures in the cervical spine is~     sufficient.~   "
20509|NCT02788747|"~     This is multi-center, randomized, double-blind, placebo-controlled study in patients with~     stable heart failure with reduced ejection fraction (HFrEF) to evaluate the effects of~     multiple subcutaneous injections of elamipretide on left ventricular function.~   "
20510|NCT02788734|"~     The purpose of this study is to learn about focal compressive median neuropathy at the wrist~     (Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the~     upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled~     in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium~     (INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A,~     CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy,~     or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via~     email to participate in this online study.~   "
20511|NCT02788721|"~     The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study~     evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses~     of GLPG2451 and GLPG2222 in healthy subjects. The purpose of the study is to evaluate safety~     and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given~     to healthy subjects compared to placebo as well as of multiple doses of the combination of~     GLPG2451/GLPG2222 compared to GLPG2451/placebo.~   "
20512|NCT02788708|"~     This phase I trial studies the side effects and best dose of lenvatinib mesylate when given~     together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or~     primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the~     growth of tumor cells by blocking a protein needed for cell growth and may block the growth~     of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving lenvatinib~     mesylate and paclitaxel together may work better in treating patients with endometrial,~     ovarian, fallopian tube, or primary peritoneal cancer.~   "
20513|NCT02788695|"~     A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal~     Study of Ageing (NICOLA). There are three key aims:~        1. Quantify age-related decline in a variety of visual functions within a populations~          based cohort.~        2. Explore the mechanisms underlying age-related visual impairments.~        3. Investigate how visual function impacts vision related quality of life.~   "
20514|NCT02788682|"~     Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response~     and is associated with clinical progression of many diseases. Our aim is to assess influence~     of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs),~     rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon~     based therapy in chronic Hepatitis C patients in Egypt.~      Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism)~     in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be~     assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy~     outcome.~   "
20515|NCT02788669|"~     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the~     third most common cancer in incidence and mortality in France. The vast majority of these~     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:~     adenoma. All CCR with the same disease stage do not have the same prognosis. Various~     parameters have been identified as factors influencing the prognosis and allows adjustment~     of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the~     tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of~     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF~     mutation is an independent poor prognostic factor.~      LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors.~     It is involved in the clearance of matrix proteases. A loss of expression or a decrease of~     the LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This~     effect was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The~     decrease in the immunohistochemical expression and LRP-1 genomic in hepatocellular~     carcinomas and lung adenocarcinomas was correlated with a decrease in the overall survival.~     In CRC, only one immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has~     been published to date. This study shows that tumor cells express LRP-1, but in nearly half~     the cases, weaker than in normal colonic cells. The clinical and prognostic impact of LRP-1~     expression in colon cancer and its association with a particular molecular or morphological~     profile has not been studied to date.~      In this work, the investigators will study the immunohistochemical and genic expression of~     LRP-1 in a series of colorectal cancers.~   "
20516|NCT02788656|"~     This pilot study will assess the impact of sacubitril/valsartan (trade name Entresto) on the~     elevated pulmonary artery pressures in patients with heart failure with reduced ejection~     fraction, measured using a previously implanted hemodynamic monitoring device (CardioMEMS).~   "
20517|NCT02788643|"~     Collagens are proteins present in all tissues. Besides their structural role, recent data~     showed that they were able to regulate many cellular functions. Many interactions occur~     between extracellular matrix macromolecules, especially collagen, and various cell types.~     These interactions can be controlled by peptides derived extracellular matrix~     macromolecules, called matrikines. Previous work from the investigators laboratory and~     others have shown that several C-terminal domain (NC1 domains) from basement~     membrane-associated collagens could regulate many cellular activities.~      Lung is an organ particularly abundant in basement membranes. It is likely that various lung~     diseases may affect metabolism of basement membrane associated collagens. To the~     investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and~     collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in~     various pathophysiological situations.~      The aim of this study are to:~        -  Study the presence of collagen IV and XIX (or fragments) in different types of sampling~          such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies~        -  Evaluate quantitative variations of expression of these collagen in different pulmonary~          diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia,~          pneumonitis or lung cancer.~   "
20518|NCT02788630|"~     This study will evaluate the efficacy of an intervention to improve quality and duration of~     self-regulated nighttime sleep (the amount of time the child maintains a combination of~     uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental~     intervention).~   "
20519|NCT02788617|"~     This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological~     assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.~   "
20523|NCT02788565|"~     Data from this study will contribute additional knowledge regarding patient outcomes and~     direct somatostatin analogue (SSA) treatment related costs in clinical practice in the~     Nordic countries. Such knowledge can be of importance in a treatment decision, decision~     support for development of care, follow up and training of both patients and primary care~     nurses.~   "
20524|NCT02788552|"~     Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be~     common in people with nutritional deficiencies or alcohol dependence. The primary cause of~     WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent~     patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may~     lead to significant, long-term brain dysfunction with severe effects on work, personal and~     social function. Whilst effective treatment may greatly reduce severe disability and the~     human and social costs of this illness, almost no evidence exists on optimal dosing~     regimens. This project proposes to develop quality evidence for effective treatment of WKS~     in an Aboriginal setting.~   "
20525|NCT02788539|"~     This project will work to increase knowledge about the utility of a website for management~     of chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators~     to patient use. In order to gather this information, the investigators will conduct a~     Science Cafe with 30 individuals (including participants with chronic pain, who have family~     members with chronic pain or are a stakeholder in the chronic pain community) to gather~     feedback about how to tailor the OWL website to their needs and preferences and how to~     improve ease of use for this tool. The investigators will also pilot two cohorts with 40~     patients with chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile~     health chronic pain management resource, measuring pain impact (pain severity, pain~     interference, physical function) and pain associated outcomes (e.g., depression, anxiety,~     fatigue, sleep disturbance, ability to participate in social roles and activities, pain~     self-efficacy, health education impact and internalized stigma related to chronic pain).~   "
20526|NCT02788526|"~     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the~     second leading cause of cancer-related death. Surgical resection is still the main radical~     approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the~     further improvement of prognosis of HCC patients. The conventional risk factors of~     recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture.~     Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of~     recurrence after hepatectomy. The investigators' previous study showed that the recurrence~     rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was~     confirmed as the only independent risk factor for the overall and disease-free survival of~     HCC patients in multiple variables analysis. It is important to reduce the recurrence and~     prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has~     been utilized as an adjuvant therapy after hepatectomy, but its significance is still~     unknown. Then, the investigators design the current prospective randomized clinical trial to~     evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk~     (>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.~   "
20527|NCT02788513|"~     The study is designed to compare the effects of BI 425809 compared to placebo in patients~     with cognitive impairment due to Alzheimer's Disease.~   "
20528|NCT02788500|"~     The overall aim of this project is to gain an in-depth understanding of the epidemiology of~     sports-related injuries and illnesses in parasport in order to assist the identification and~     development of specific injury prevention strategies adapted to parasport.~   "
20529|NCT02788487|"~     The objectives of this study is to compare short-term outcomes of CPAP and TRD in the~     treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during~     3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life,~     degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI,~     respectively.~   "
20530|NCT02788474|"~     Identifying biomarkers to predict the clinical course and benefits of therapy early in the~     course of the disease remains one of the most urgent and relevant challenges to improve~     overall patient management, to prevent treatment delay or overtreatment. This study is~     conducted to examine the effect of nintedanib treatment on change in biomarkers indicative~     of extracellular matrix turnover which have been shown recently to correlate with disease~     progression. This study further aims to confirm the association of biomarker course during~     the first three months of treatment and disease progression.~   "
20531|NCT02788461|"~     A randomized phase II trial to assess the efficacy and safety of selective metabolically~     adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving~     definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive~     conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost.~     All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan~     within two weeks prior to starting treatment. The primary outcome is to determine if dose~     escalation to metabolically active tumor subvolumes will reduce local-regional failure rate~     at 2 years.~   "
20532|NCT02788448|"~     The purpose of this Clinical Investigation is to validate that the clinical use of the~     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm~     its performance to percutaneously close femoral arterial puncture sites in the range of~     18-24 F, post endovascular procedures.~      This is a non-inferiority study based on safety. Safety will be assessed by incidence and~     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3~     months from implantation is no worse than those associated with cut-down and sutured close.~   "
20533|NCT02788435|"~     Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest~     postoperatively. However, no clinical trials have ever been conducted to ascertain the~     efficacy of using voice rest and its impact on functional voice outcomes. The purpose of~     this randomized-clinical trial is to determine if the prescription of voice rest has an~     impact on voice outcomes following phonosurgery.~   "
20562|NCT02788058|"~     To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy~     for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI~     therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.~   "
20534|NCT02788422|"~     Thorough, understandable discharge instructions empower caregivers, allowing them to provide~     optimum care of their children during illness. Unfortunately discharge instructions are~     often incomplete and difficult to understand. The use of video discharge instructions has~     been shown to increase patient understanding of their illness. The investigators would like~     to know if using video discharge instructions for caregivers of children with middle ear~     infections helps to better understand how to take care of children at home, potentially~     allowing the child to feel better faster. The investigators will be comparing video~     discharge instructions to a paper handout to see if the former leads to improved well-being~     of the child and improved caregiver knowledge, satisfaction and anxiety.~   "
20535|NCT02788409|"~     This study is conducted to estimate population-based incidence rates of second primary~     malignancies among patients with CRPC similar to those treated with Xofigo. These rates will~     provide context for second primary malignancy incidence rates from the REASSURE study.~      Furthermore this study aims to provide further information about the documentation of bone~     metastases in Medicare data and the extent of use of only oral androgen deprivation drugs~     among patients with Medicare Part D coverage, as well as to estimate overall survival of the~     study population.~   "
20536|NCT02788396|"~     This study aims to assess the impact of NC balloon post-dilatation on coronary~     microcirculation in patients with ST segment elevation myocardial infarction (STEMI)~     undergoing primary percutaneous coronary intervention (PPCI).~   "
20537|NCT02788383|"~     Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD~     negative pregnant women.~      The investigator want to demonstrate that this is an useful and efficient method.~   "
20538|NCT02788370|"~     Aim of this study is to compare cardiopulmonary response to conical-PEP breathing during~     exercise in older people.~   "
20539|NCT02788357|"~     This proposal evaluates the safety and effectiveness of a noradrenergic drug named~     atomoxetine combined with motor training to enhance cortical plasticity and improve hand~     function after stroke.~   "
20540|NCT02788344|"~     This is a multicenter multidisciplinary study designed to investigate patient, provider, and~     system-related factors that are associated with the quality and safety of initial management~     for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12~     hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for~     suspected STEMI independently relates to provider practice patterns and system barriers. It~     is further postulated that non-compliance with target delays in implementing percutaneous~     coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital~     clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion~     therapy within target delays is associated with increased rates of false-positive cardiac~     catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding~     events.~      The project will be conducted in three emergency medical services and 23 public and private~     (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over~     the index hospital stay period will be retrospectively collected for all the patients~     included in an ongoing prospective regional hospital-based clinical registry of suspected~     STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is~     anticipated.~      In this observational retrospective study, no specific intervention is assigned to~     participants. All diagnostic testing, procedures, and medication ordering are performed at~     the discretion of attending physicians. No enrollment or follow-up visits are planned.~      The primary effectiveness outcome is timely acute reperfusion therapy. The secondary~     effectiveness outcomes include false-positive cardiac catheterization laboratory activation~     for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical~     outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and~     major bleeding events. Multivariable logistic regression model will be developed to identify~     baseline characteristics that are independently associated with timely acute reperfusion~     therapy. Propensity score analysis will be performed for comparing clinical outcomes between~     timely acute reperfusion therapy recipients and non-recipients.~   "
20541|NCT02788331|"~     The explanatory mechanism of the relationship between the volume of surgical procedures~     performed by individual hospitals and the occurrence of serious adverse events is not clear.~     Based on the  practice makes perfect  dogma, we will explore whether a learning effect can~     explain the volume-outcome relationship for complex surgical procedures using a nationwide~     dataset. Especially, we assume that increasing volume of procedures over time may be~     associated with improved outcomes.~   "
20542|NCT02788318|"~     The mortality rate is increased in patients with epilepsy, and especially among patients~     with drug-resistant epilepsy. This increased mortality is mainly related to the risk of~     SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant~     epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in~     whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental~     and clinical data strongly suggest that most of SUDEP result from a postictal respiratory~     dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating~     breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration~     of serotonergic systems of the brainstem and limbic regions may play a central role in the~     occurrence of SUDEP. The objective of this work is to look for abnormalities of the~     serotonergic transmission within regulatory regions of respiratory and autonomic functions~     in brain samples prospectively collected in patients died from SUDEP.~   "
20543|NCT02788305|"~     This study investigate the progression of labour in 459 normal weight pregnant women (BMI~     <30) and 459 obese pregnant women (BMI <30) , not in labor admitted for induction of labor.~     These women are to be investigated for success of induction of labor.~   "
20544|NCT02788292|"~     A single-centre triple-blind study looking at the addition of NAC to tumescent solution for~     liposuction and fat grafting in healthy patient volunteers already undergoing bilateral~     breast reduction. Three-dimensional reconstructions and volumetric analysis will be~     performed based on CT scans at 0, 1 and 3 months and then histological analysis will be~     performed after fat graft explantation at 3 months to determine fat graft vascularity and~     quality.~   "
20545|NCT02788279|"~     This is a Phase III, multicenter, open-label, three-arm, randomized study in participants~     with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received~     at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study~     compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus~     atezolizumab and atezolizumab monotherapy.~   "
20563|NCT02788045|"~     The purpose of this study is to assess the safety/tolerability of the 2 different vaccine~     regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and~     Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with~     Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the~     different vaccine schedules will be assessed.~   "
21055|NCT02781558|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir~     (SOF/VEL) fixed dose combination (FDC) and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks in~     participants with chronic genotype 3 HCV infection and compensated cirrhosis.~   "
20546|NCT02788266|"~     Background: The aim of this study was to evaluate the treatment of multiple gingival~     recessions associated with non-carious cervical lesions (NCCL) using a modified coronally~     advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on~     restored root surfaces.~      Methods: Twenty-three systemically healthy subjects, who were positive for the presence of~     three cervical lesions associated with gingival recessions in three different adjacent~     teeth, were enrolled in the study. The NCCL were each restored prior to surgery by using one~     of three different materials: composite resin (group 1), resin-modified glass ionomer cement~     (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements,~     including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH),~     probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL),~     keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root~     coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at~     baseline, 3 and 6 months, and 1 year postoperatively.~   "
20547|NCT02788253|"~     Mallampati score (classification of the visibility of oropharyngeal structures) should be~     performed in the sitting position, head in the neutral position, mouth widely open, and~     tongue protrudes, without phonation. However, phonation, and position modify the visibility~     of oropharyngeal structures and thus the Mallampati score. Furthermore, some patients cannot~     be evaluated in sitting position because (emergency, fractures, pain, supine position~     require for medical or surgical pathology...).~      We aimed at evaluating the predictive value of the best observable Mallampati score as~     compare to the recommended Mallampati score.~   "
20548|NCT02788240|"~     All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute~     of liver and biliary sciences, irrespective of the etiology , who have survived the acute~     phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to~     participate in the study would be enrolled. After performing baseline biochemical tests,~     patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure~     Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and~     immunohistochemical examination will be done).~   "
20549|NCT02788227|"~     Background:~      The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after~     being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is~     also no vaccine to prevent infection either before or after exposure. Researchers want to~     test an Ebola vaccine. They want to give it to people before they are exposed to the virus~     in order to prevent the disease.~      Objectives:~      To see how long-lasting and effective the vaccine rVSV[delta]G ZEBOV-GP (V920) is at~     preventing Ebola.~      Eligibility:~      Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical~     contact.~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will get the study vaccine. It will be injected into their upper arm.~      Participants will be monitored closely for at least 30 minutes. They will get a diary card~     to record any symptoms they have from the vaccine for up to 14 days.~      Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then~     every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36~     months.~      Eighteen months after they join the study, participants will be randomly assigned to one of~     two groups. One group will get a second (or booster ) dose of the vaccine. The other group~     will not get a second dose.~      This study lasts 36 months.~   "
20550|NCT02788214|"~     Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems~     or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken~     from chronically infected people. They want to identify the genetic differences in H. pylori~     strains. This could help predict which people who get infected with the bacteria will get~     cancer. This could lead to the cancer being detected earlier. It could also mean less people~     get stomach cancer.~      Objectives:~      To study genetic variations of H. pylori strains based on samples from chronically infected~     people. To identify the features of strains that might lead to severe stomach problems or~     stomach cancer.~      Eligibility:~      People ages 35 70 who need an upper endoscopy or who were recently diagnosed with stomach~     cancer~      Design:~      Participants will be screened by the doctor who does their procedure and a study nurse.~      Participants who have endoscopy will have 6 biopsies removed. These are tissue samples. They~     are about the size of a grain of rice. Participants will allow the study team to access~     reports from their stomach exam.~      Participants with stomach cancer will donate some of the tissue that will be removed during~     their clinical care. They will allow the study team to access reports of their surgery. They~     will also allow them to access the microscope slides of their stomach.~   "
20551|NCT02788201|"~     Background:~      Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested~     for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to~     treatment. It may also help determine which drugs fight urothelial cancer based on the~     characteristics of a tumor. Researchers want to test if this model can choose the best~     therapy for advanced urothelial cancer within 3 weeks and how tumors respond to the next~     best therapy.~      Objective:~      To test if the COXEN model can choose the best therapy for advanced urothelial cancer within~     3 weeks.~      Eligibility:~      People ages 18 and older whose urothelial cancer has spread after at least 1 line of~     chemotherapy~      Design:~      Participants will be screened with medical history, physical exam, blood and urine tests,~     and tumor scans.~      Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle~     will remove a small piece of tumor.~      Participants will repeat screening tests, plus have an EKG and scan. For the scan, they will~     get an injection of radioactive drug. They will lie in a machine that takes pictures.~      Participants will take the drugs assigned by the COXEN model. They will have visits every 2~     3 weeks. These will include blood and urine tests.~      Participants will have tumor scans every 8 9 weeks.~      Participants may have another biopsy.~      Participants will take the drugs until they can t tolerate the side effects or their cancer~     worsens. They may be assigned to a second COXEN therapy.~      Participants will have a follow-up visit 4 5 weeks after their last drug dose.~      Participants will be contacted by phone every few months until death.~   "
20586|NCT02787746|"~     This study will evaluate the safety and tolerability of donepezil in treatment of AD~     patients in China, and also investigate the relationship between Apo-E gene type with~     adverse events of donepezil.~   "
20552|NCT02788188|"~     Background:~      Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal~     respiratory virus. People often get MERS through close contact with an infected person.~     Scientists are worried that MERS may spread and cause more infections. There are no vaccines~     or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able~     to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of~     antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid~     part of cow blood.~      Objective:~      To evaluate the safety and tolerability of SAB-301 in healthy adults.~      Eligibility:~      Healthy people ages 18 60 who:~      Do not have chronic medical problems~      Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal~     allergy meds and oral contraception)~      Do not have allergies to beef products~      Agree to use two forms of contraception while on study (both men and women)~      Design:~      Participants will be screened with:~      Medical history~      Physical examination~      Blood and urine tests~      Participants will have a return visit.~      They will have a physical exam and blood tests.~      They will be randomly assigned to receive either SAB-301 or a placebo which is given by~     infusion~      through an arm vein over 1 3 hours.~      They will be monitored at the clinic for 6 hours after the infusion. They will have~     additional blood draws.~      Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At~     each visit they will be evaluated and have blood and urine tests.~   "
20553|NCT02788175|"~     Background:~      In most people infected with human immunodeficiency virus (HIV), their immune system cannot~     control HIV infection. They need drugs called combination antiretroviral therapy (cART) to~     control the HIV. When people stop cART treatment, their immune system cannot control the~     infection again. They can also become resistant to cART and have lasting side effects.~     Researchers want to test if the drug vedolizumab is effective at controlling HIV infection~     without the need for cART.~      Objective:~      To teste if vedolizumab is safe and can control the amount of HIV in the blood when cART is~     not taken.~      Eligibility:~      People ages 18-65 who have HIV and are being treated with cART~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity.~      Blood and urine tests~      Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It~     will include repeats of the screening tests and:~      Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white~     blood cells from the blood. The rest of the blood is returned to the participant.~      Neurologic exam: The nerves and reflexes are tested.~      First vedolizumab infusion through an arm vein~      Participants will have visits every 4 weeks for 30 weeks. These will include:~      Vedolizumab infusions~      Repeats of baseline tests~      Participants will have more visits for blood draws.~      Participants will keep taking cART until after the week 22 infusion.~      After discontinuing cART at study week 22, participants will be seen every two weeks to~     monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in~     between infusion visits and will only take about 1 hour to complete. cART will be restarted~     if a participant s HIV levels go up to high, or if their CD4 cell counts decreases by too~     much.~      For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These~     will include blood tests and a physical exam.~   "
20554|NCT02788162|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
20555|NCT02788149|"~     To investigate the accuracy of neck ultrasound in identifying and discriminating the~     severity of obstructive sleep apnea (OSA).~      Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for~     identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in~     patients with OSA.~      Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.~      The investigators will compare these results to the results from polysomnography study.~   "
20556|NCT02788136|"~     The study design included six visits. During the first visit (visit 0), the subjects~     underwent physical examination(height, weight, body mass index (BMI), arm span, and upper~     segment measurement) and testicular ultrasound (US) for the calculation of testicular~     volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed~     by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed~     each of five following consecutive days after the hCG injection. A blood sample was taken at~     each visit after an overnight fast~   "
20557|NCT02788123|"~     The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium~     dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in~     subjects with NSAID-induced gastropathy in 14±2 days of treatment.~   "
20558|NCT02788110|"~     Background:~      Non-invasive forms of respiratory support have been developed to manage respiratory distress~     and failure in premature newborns without exposing them to the risks associated with~     invasive mechanical ventilation. It has been difficult to synchronize non-invasive~     ventilation due to the large air leaks, high respiratory rates, and small tidal volumes~     inherent to this interface and population. Neurally adjusted ventilatory assist (NAVA) is a~     novel mode of ventilation that uses a functional naso/orogastric tube with embedded~     electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this~     Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to~     support these efforts as needed. Few studies have examined the use of NAVA with non-invasive~     ventilation (NIV) in preterm neonates. A group at Arkansas Children's Hospital recently~     completed a study, looking at work of breathing in an animal model comparing NIV NAVA with~     the unsynchronized nasal intermittent positive pressure (NIPPV) mode currently used at this~     hospital. They were able to show that work of breathing was lower with NAVA in this model.~     This study will take what was shown in the animal model and translate this to the bedside.~     Using respiratory inductance plethysmography to measure thoracoabdominal asynchrony, this~     study will compare work of breathing during NIPPV versus NIV NAVA in preterm neonates with~     respiratory insufficiency.~      Hypothesis:~      Work of breathing as estimated by the phase angle (θ) using respiratory inductance~     plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized~     NIPPV in premature neonates with respiratory insufficiency.~      Methods:~      Fifteen preterm neonates of between 1 and 2 kg current weight and receiving non-invasive~     ventilation will be enrolled in the study. The infants will be ventilated using NIV NAVA and~     NIPPV applied in random order for 15 minutes each while using respiratory inductance~     plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing.~      Significance:~      This study will identify whether or not NIV NAVA has advantages over NIPPV for improving~     work of breathing in premature neonates.~   "
20559|NCT02788097|"~     In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4~     of culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high~     rate of implantation has been observed. In addition, a greater number of these implantations~     resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In~     this prospective randomised control study, the investigators will investigate whether this~     increased viability, is due either to embryo quality, endometrial receptivity, or a~     combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or~     P+5.~   "
20560|NCT02788084|"~     1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of~          formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.~        2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas~          (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements~          common to both FPPE and cfDNA specimens.~        3. Determine if certain types of BNHL are more likely to have mutation profiles common to~          both FFPE & corresponding cfDNA (FFPE-cfDNA dyads)~        4. Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or~          both) are of prognostic value after a clinical follow-up of 2 years from the time of~          diagnosis.~   "
20564|NCT02788032|"~     This open-label, prospective, controlled intervention study involves evaluating tolerance~     and acceptability of an Oral Nutrition Supplement (ONS; EnergieShake®) in 16 adult patients~     who are already taking an ONS. Following a 2-day baseline data collection on their current~     ONS, patients switch to the test ONS, which is taken for a further 8 consecutive days.~     Patients revert to their current ONS at the end of the study. Patients act as their own~     controls and thus all patients are allocated the same intervention.~      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept~     for participants throughout the study period. Participants' height and weight will be~     collected at baseline (weight at end will also be collected), all medications will be~     documented, and relevant medical and dietary histories will be recorded. A questionnaire at~     the end of the intervention period will be administered collecting participants' views on~     the acceptability (taste and palatability) of the test ONS. Taste and palatability will be~     assessed via a questionnaire that uses a Hedonic scale to quantify preference.~   "
20565|NCT02788019|"~     This is a randomized noninferiority interventional study to determine the equivalence of two~     adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial~     foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during~     their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day~     Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and UTSW Outpatient~     Surgery Center) for eligibility. Eligible individuals may be introduced to the study in the~     orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent~     patients will be randomized (break-seal method) to receive either a mid-thigh or distal~     thigh block using ropivacaine prior to foot, ankle, or leg surgery. The following~     measurements will be obtained to determine the change in sensory distribution: pinprick test~     with Neuropen, maximum voluntary isometric contraction before and after block, postoperative~     pain scores (24 hrs and at discharge) and postoperative opiate consumption.~   "
20566|NCT02788006|"~     Multicenter prospective phase II study evaluating regorafenib in older patients with~     metastatic colorectal cancer~   "
20567|NCT02787993|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine~     the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive~     behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety,~     depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and~     the US.~   "
20568|NCT02787980|"~     Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born~     at full term.~      Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea).~     Study the relationship between the onset of infectious complications, mainly the type of~     necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the~     evolution profile of serum tryptase levels.~   "
20569|NCT02787967|"~     The study will be conducted in asthmatic children aged 5 to 11 years and is based on a~     single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler~     (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate~     (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI~   "
20570|NCT02787954|"~     The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and~     metabolomic characteristics of liver tumors. The study also aims to determine if these~     imaging characteristics are correlated with clinical outcomes.~   "
20571|NCT02787941|"~     Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in~     several studies. Pharmacists play a significant role in enhancing medication adherence and~     reducing rates of mortality and re-admission to hospital by performing medication~     reconciliation and tailoring, and patient education. The purpose of this study is to~     determine the effect of pharmacist-delivered multifaceted intervention on medication~     adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be~     designed as a randomised controlled trial with blinded outcome assessors. The population~     includes patients who survive during hospitalisation with discharge diagnosis of acute~     coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two~     counselling sessions within 1 week before and after hospital discharge including medication~     reconciliation and tailoring, and support with pill organiser and drug information leaflet.~     Primary outcome measure is the proportion of patients adherent to medication at 1 month~     after discharge. Secondary outcome measures are the proportions of patients (1) adherent to~     medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3~     months after discharge. The investigators also measure (4) the change in quality of life and~     (5) beliefs about medicines from baseline at 3 months.~   "
20572|NCT02787928|"~     In the United States the incidence of cesarean deliveries have increased over the last~     several decades and is currently approximately 30% nationwide. The anesthesia and analgesia~     for elective c-sections vary between institutions.~      Parturients present a unique challenge for the anesthesiologist as the mother has to care~     not only for herself, but also for the newborn postpartum. While intrathecal opioids provide~     adequate pain relief, they do so at the cost of bothersome side effects for patients, such~     as pruritus and nausea/vomiting.~      Intrathecal hydromorphone has started to be explored as a new option for intrathecal~     analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of~     intrathecal dilaudid was safe and effective as compared to intrathecal morphine for~     analgesia after cesarean delivery. Additionally they showed no difference in side effect~     profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal~     dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results~     were inconclusive, but the dosage of hydromorphone was reported to be without adverse~     effects.~      Virginia Commonwealth University Health Systems has successfully instituted the use of~     intrathecal morphine with superior analgesia but with undesired side effects, most notably~     pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative~     options for post cesarean section analgesia. The investigators are interested in determining~     the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our~     institution has never utilized intrathecal hydromorphone for our patient population, it has~     been studied at various other institutions where it has been found to be safe and~     efficacious with an acceptable side effect profile.~   "
20573|NCT02787915|"~     This trial is to evaluate the safety and effectiveness of autologous type-1 polarized~     dendritic cell vaccines (patients' autologous DC1s loaded with multiple antigens CTL epitope~     peptide complexes), after radical resection for patients with stage III-IV renal cell~     carcinoma. Autologous cytotoxic of T lymphocytes (CTL) induced by type-1 polarized dendritic~     cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .~   "
20574|NCT02787902|"~     The purpose of this study is to develop, implement, and evaluate a behavioral weight~     management intervention with a communication training component for Mexican-American women.~     The study has three specific aims.~      Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral~     weight loss treatment using results from formative data collected from Mexican-American~     mother-daughter dyads. The adapted intervention will focus on improving dyadic communication~     and collaboration for providing reciprocal support for healthy eating and physical activity~     behaviors.~      Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter~     dyads. Dyads will be randomly assigned to partner-based treatment with or without~     communication skills training.~      Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and~     psychosocial variables with changes in measures assessing interpersonal communication.~   "
20575|NCT02787889|"~     The investigators determined effects of 8-week dietary protein intake in mixed meals with~     uneven or even consumption pattern on the metabolic outcomes of whole-body net protein~     synthesis and muscle protein synthesis in older participants.~   "
20576|NCT02787876|"~     To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in~     children with solid tumors~   "
20577|NCT02787863|"~     Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic~     effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary~     system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper~     respiratory tract in patients with bronchopulmonary pathology before and after use of~     bacterial vaccines. Identification of mayor lymphocytes subpopulations, proinflammatory~     cytokines, inflammatory markers in patients in the dynamics of the vaccination process.~     Study the profile of humoral immune response in patients under different schemes of~     vaccination. Detection of levels of autoantibodies against tissue antigens in the sera of~     vaccinated patients with inflammatory diseases of the respiratory tract. Assessment of the~     clinic and functional status bronchopulmonary system in the immunized patients. Development~     of methodical recommendations / study guides for the improvement of therapy in patients with~     different inflammation diseases of the respiratory tract.~   "
20578|NCT02787850|"~     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the~     abdomen using an applicator with the Crown Cooling Insert.~   "
20579|NCT02787837|"~     Prospective Multi-centre Studies of Prognostic Factors in Castration resistant PROState~     Cancer Treated With Abiraterone (PROSABI)~   "
20580|NCT02787824|"~     The purpose of this study was to compare the efficacy of two regimens of intravenous iron~     sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)]~     on the response of rHuEPO in the maintenance phase of its administration in hemodialysis~     patients.~   "
20581|NCT02787811|"~     Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young~     Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle,~     followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon;~     FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter~     of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge,~     5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.~   "
20582|NCT02787798|"~     The hyperactivation of the sympathetic nervous system is a feature of the heart failure and~     the determinants of disease progression and risk of sudden cardiac death. This research~     project aims to study, in the drug use conditions provided in the summary of product~     characteristics based on European marketing authorization (indications and dosage), the~     effect of the Entresto® on the activity of sympathic nervous system using the reference~     method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA).~     This study will try to determine if the double inhibition of AT1 receptor and neprilysin~     activity result in lower sympathic nervous system burst rate versus single AT1 receptor~     inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II~     inhibitor.~   "
20583|NCT02787785|"~     The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial~     infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will~     have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator~     (S-ICD) when compared to those receiving conventional medical therapy.~   "
20584|NCT02787772|"~     Cirrhotic patients have a high incidence of abdominal wall hernias. Ascites and sarcopenia~     are risk factors to development of bigger hernias and frequent need for urgent surgery due~     parietal complications. However, hernia surgery is usually delayed in cirrhotic patients~     because of high morbidity and mortality.~      Methods: A prospective study of cirrhotic patients with abdominal wall hernia during January~     2009 to November 2014. Demographics, characteristics of underlying liver disease, type of~     hernia, complications and mortality of 246 enrolled patients were collected. Elective hernia~     repair was performed in 57 unselected patients, 186 patients were kept in clinical follow~     up. During follow up urgent hernia surgery was performed when unavoidable~   "
20585|NCT02787759|"~     We propose a study that uses challenging walking exercises as a research training program~     and compare balance and walking abilities against a non-challenging exercise program, in a~     group of 40 people with long standing (> 6 months) weakness that occurred after a stroke.~     Our main balance measure will be changes with the Berg Balance Score and Dynamic Gait Index,~     and our main walking measure will be walking speed over a 10 meter walkway and distance~     walked over a six minute period. Also, we will measure balance confidence, using scores on~     Activities-specific Balance Confidence Scale, changes in quality of life as measured by the~     Geriatric Depression Scale, SF-36 and Stroke Impact Scale. If challenging exercises are~     shown to be more effective than non-challenging exercises, then we will share this promising~     new approach with the community in hopes of improving people's lives after a stroke.~   "
20587|NCT02787733|"~     Rationale: Numerous studies have shown the positive effect of a healthy diet and regular~     moderate exercise. Although, exercise has also been correlated with an increase in reactive~     oxygen species (ROS) production and a higher incidence of injury. ROS production seems to~     induce muscle damage, which reduces muscle performance and induces fatigue. Increasing~     muscle recovery could be an effective way to increase exercise performance. Several food~     ingredients have been of growing interest due to their specific functioning on the human~     body. Citrus flavonoids are abundantly available in citrus fruits. Prior studies show a~     positive effect of citrus flavonoids on endothelial function, by promoting vasodilation. In~     addition it has a positive effect on the nitric oxide (NO) synthesis, a known compound in~     regulating endothelial response. This capacity of citrus flavonoids could be useful in~     stimulating performance and recovery after exercise. Additionally, the ability of scavenging~     ROS could reduce muscle damage caused by exercise induced oxidative damage.~      Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise~     recovery and performance.~      Study design: Randomized, double-blind, placebo-controlled study with parallel design, in~     which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a~     pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks~     citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each~     morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.~      Study population: The subjects will be healthy normal weight trained males, with an age of~     18 - 25. Additionally, subjects are non-smokers and free of a medication.~      Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo~     group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive~     weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the~     placebo treatment.~      Main study parameters/endpoints: The main study parameter is the average amount of work load~     produced during the 10-minute time trail test. In addition, oxygen per minute will be~     determined as well as the heart rate. Finally, for each test, the subjective rating of~     perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a~     Borg scale.~   "
20588|NCT02787720|"~     A randomized controlled blinded study in patients treated for Acute Respiratory Distress~     Syndrome (ARDS) in the mixed medical-surgical intensive care units (ICU) of four academic~     teaching hospitals in Tehran, Iran were conducted to examine the effects of Varied~     Rehabilitation Techniques on Survivors of ARDS patients. Patients were randomized in the~     emergency department at the time of ICU admission to one of four groups labeled groups 1, 2,~     3 and 4, respectively.~   "
20589|NCT02787707|"~     The main objective of this research is the role of the Persumac(an Iranian traditional~     remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer~     patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting~     in acute and delayed phase.~   "
20590|NCT02787694|"~     Locomotor disability remains a major obstacle to community function in stroke survivors.~     This disability is best characterized by the reduced gait speed and enhanced risk of falls~     that is observed in the majority of stroke survivors. Current robotic systems have focused~     on repetitive stepping in constrained, less-challenging environments than overground~     training and have failed to produce results that can justify their use. In contrast to this~     approach, this study will use a combinatorial approach on a moving platform~     (KineAssist-Mobility Activity Center) that simulates and enhances the challenges of~     overground training. We focus on five critical factors that contribute to reduced speed and~     fall risk during mobility activities: 1) lower limb weakness; 2) slow lower limb movements;~     3) reduced balance; 4) reduced ability to respond to challenges during walking; and 5)~     reduced aerobic capacity. The end product of this study is to develop a comprehensive and~     standardized system for assessing and prescribing specific training modalities that can be~     used by clinicians to help stroke survivors who are limited by slow walking speed and high~     fall risk, and can improve participation in mobility activities.~   "
20591|NCT02787681|"~     The aim of this study is to verify the safety and accuracy of an FDA-approved device called~     the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted~     in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™~     Gauge is able to properly determine the correct position of the endotracheal tube without~     the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight~     (68) subjects will participate in this study at three (3) study centers in the Inland Empire~     of Southern California, with subjects being enrolled at Loma Linda University Medical~     Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.~   "
20592|NCT02787668|"~     The purpose of this study is to determine the effects of a low carbohydrate diet vs a low~     fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of~     inflammation, insulin resistance, and body composition in obese adolescents with~     non-alcoholic fatty liver disease (NAFLD).~   "
20593|NCT02787655|"~     The purpose of this study is to examine the impact of a combined cognitive training and~     aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic~     exercise will potentiate and increase the generalizability of the cognitive training.~     Importantly, this study will focus on older adults at-risk for mobility disability. This~     area is of particular importance considering a large percentage of adults are entering old~     age and therefore likely to suffer from age-related cognitive decline and mobility~     disability.~      To address the investigators' research question 60 adults (age 18-89) will be randomized to~     one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic~     Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the~     same format shown to improve a broad range of executive functions in older adults in~     previous research. The cognitive training arm will consists of a popular~     commercially-available brain fitness program that has demonstrated specific cognitive~     improvements and high adherence.~   "
20594|NCT02787642|"~     A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable~     soft-tissue sarcoma.~   "
20595|NCT02787629|"~     Patients presenting for elective surgery requiring orotracheal intubation will be randomized~     to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then~     having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in~     the more common fashion with the GlideScope being inserted first and having the ETT then~     advanced via the pharynx into the trachea.~   "
20596|NCT02787616|"~     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the~     facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well~     understood and current methods to treat this disease are often unsatisfactory. The purpose~     of this study is to develop gene expression profiles of papulopustular rosacea compared to~     those of normal skin. The investigators hope to better understand the abnormal gene~     functions that might contribute to this condition. This understanding may lead to the~     development of additional and better treatments for rosacea.~   "
21205|NCT02779595|"~     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography~     and spirometry will be investigated in patients at risk for postoperative pulmonary~     complications. Those patients undergo lung and flail chest surgery.~   "
20597|NCT02787603|"~     Introduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but~     the diagnosis of pulmonary infection sometimes is difficult in these patients due to similar~     signals and clinical symptoms in both pathologies. Furthermore, when it is possible the~     diagnosis of pulmonary infection, physicians may have difficult to determine etiology and~     delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to~     determine the period of use of antibiotics in patients with acute respiratory infections. It~     is specific for bacterial infections and it have showed as a marker of severity infection~     and may help to determine interruption period of antibiotic therapy in a safety way for the~     patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with~     decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection.~     Methods: In this pilot project will be included around 100 patients, randomized in two~     groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B~     (antibiotic period will be determined by the physician without the knowledge of PCT levels).~     Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be~     compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and~     readmission in 30 days. This study will determine the sensibility/specificity of PCT in~     patients with DAHF.~   "
20598|NCT02787590|"~     Participants are randomly allocated to one of two treatment groups. In one group,~     participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In~     the other group, participants are given placebo (dummy) capsules to take orally for 24~     months. At the start of the study, when they receive their medication, participants complete~     a number of questionnaires and motor (movement) tests (a walking test and a finger tapping~     test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18~     and 24 and 26 months, where they are asked about their health and any medication they are~     taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits,~     the participants will be asked to attend in the 'OFF medication' state (having omitted their~     usual PD medication) so that the researchers can get a true picture of their disease without~     it being masked by their normal medication.~   "
20599|NCT02787577|"~     Short sleep duration has been associated with increased risk of weight gain and development~     of non-communicable diseases. Sleep deprivation studies have suggested the link between~     restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal.~     However, the severity and acuteness of sleep restriction schedules in laboratory-based~     studies could hinder the ecological validity of the findings. The pragmatic way forward is~     to assess how improved sleep in habitually short sleepers impacts the aforementioned~     outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as~     well as how improved sleep duration and/or quality impact metabolic health, body~     composition, energy balance and cardiovascular risk.~   "
20600|NCT02787564|"~     The study aims to investigate whether the provision of free fresh fruits and vegetables to~     middle-aged men at risk of poverty increases their fruit and vegetable intake over a period~     of 4 weeks.~   "
20601|NCT02787551|"~     Primary Objective:~      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination~     (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.~      Secondary Objectives:~      To compare the overall efficacy and safety of the insulin glargine/lixisenatide fixed ratio~     combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without~     pioglitazone) in patients with type 2 diabetes.~      To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension~     period.~   "
20602|NCT02787538|"~     This proof-of-concept randomized trial evaluates the effectiveness of using an online~     decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US~     patients with rheumatoid arthritis.~   "
20603|NCT02787525|"~     The aim of the study is to compare intermedium-term clinical outcomes, including~     thromboembolic events and bleeding complications between patients with non-valvular atrial~     fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left~     atrial closure).~      A questionnaire is sent to the patients and if there is some information missing or unclear,~     the investigators will contact the patient or the treating physicians to get the~     missing/unclear information.~      The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who~     underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital~     und Zurich University hospital) and a similar group of 500 patients with non-valvular AF~     treated with oral anticoagulation (OAC).~      In order to compare the two groups and reducing the bias due to confounding variables, a~     propensity score matching will be performed.~      Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy~     and safety in comparison to lifelong oral anticoagulation in patients with non-valvular~     atrial fibrillation.~   "
20604|NCT02787512|"~     Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is~     still necessary in case of patients with cholangitis or very high level of bilirubin or~     patients who are expected to receive delayed surgery.~      The aim of this clinical trial is to demonstrate non-inferiority of uncovered~     self-expandable metal stent to plastic stent for PBD by endoscopic retrograde~     cholangiopancreatography in patients with periampullary cancer undergoing curative intent~     pancreaticoduodenectomy.~   "
20614|NCT02787382|"~     BACKGROUND~      Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral~     or autoimmune etiologies. Human CMV represents one of the leading causes of congenital~     infections worldwide. There is limited data regarding the cardiac function of fetuses and~     infants with CMV.~      OBJECTIVE~      To provide insight regarding the presence of myocardial involvement in fetuses and infants~     with CMV infection.~      PATIENTS & METHODS~      Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period.~     Patients will undergo detailed US examinations including dedicated neurosonography and~     echocardiography starting at the time of the first referral and every 3-4 weeks until~     delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy~     women from the group will serve as controls~   "
20615|NCT02787369|"~     This research study is studying a drug called ACY-1215 in combination with ibrutinib or~     idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocyic Leukemia~     (CLL).~   "
20605|NCT02787499|"~     The study design is an open-label, randomized controlled trial. The study will be conducted~     at study sites in Uganda and South Africa. The study population will include HIV-infected~     patients on first-line antiretroviral therapy with a recent viral load >1,000~     copies/milliliter (or dried blood spot viral load >1,000 copies/milliliter). Eligible~     participants will be randomized to the WHO-based standard of care for management of~     virologic failure or immediate resistance testing to guide ART regimen decisions. The~     primary outcome of interest will be viral suppression (<200 copies/mL) at 9 months after~     study enrollment, and will be assessed using an intention to treat analysis, where missing~     or absent results will be considered failures. Secondary outcomes of interest will be viral~     suppression below the limit of assay detection, viral suppression on continuation of~     first-line (non-nucleoside reverse transcriptase inhibitor [NNRTI]-based) therapy, drug~     resistance at study conclusion, and mortality, among others. The overarching goal of this~     study is to determine whether addition of routine resistance testing, to guide management of~     virologic failure and sustain the successful completion of the HIV continuum of care,~     improves clinical outcomes and reduces costs for patients with virologic failure on~     first-line therapy in sub-Saharan Africa.~   "
20606|NCT02787486|"~     In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its~     guidelines that now recommend physicians are ethically obligated to fully inform all~     pregnant women that screening for fetal chromosomal abnormalities including biochemical~     screening tests and invasive procedures such as CVS or amniocentesis is available,~     regardless of age. Further, it is entirely up to the patient to decide whether or not she~     wishes to be screened for fetal chromosomal abnormalities without judgment from the~     physician.~      Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and~     fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now~     available. These LDTs have not been cleared or approved by the U.S. Food and Drug~     Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation,~     certification of the laboratory is required under the Clinical Laboratory Improvement~     Amendments (CLIA) to ensure the quality and validity of the test.~      To sample collection study will obtain whole blood specimens from pregnant subjects to be~     used for development of prenatal assays to assist in the screening for fetal genetic~     abnormalities, infectious and other diseases, and blood group typing through detection of~     circulating cell-free DNA extracted from maternal plasma.~   "
20607|NCT02787473|"~     To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer~     treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by~     docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is~     also planned.~   "
20608|NCT02787460|"~     The University of Florida offers relationship education programs named ELEVATE, for couples,~     and Smart Steps, for couples in stepfamilies, in Citrus, Duval, Manatee, Palm Beach, and~     Santa Rosa counties. Each workshop comprises 4 2.5-hour long sessions. The STREAMS~     evaluation will examine whether text messages informed by behavioral insight theory can~     improve couples' attendance at relationship skills education group sessions, and if so,~     which kinds of messages are most effective~   "
20609|NCT02787447|"~     The investigators postulated that the exploitation of the pro-immunogenic effects of~     radiotherapy with thymosin might result in abscopal responses among patients with metastatic~     cancer. The research is designed to evaluate the efficacy and toxicity of patients treated~     with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker~     analysis in blood and tumor samples is also planned.~   "
20610|NCT02787434|"~     This is a multicenter study that involves research on screening for prostate cancer. This~     study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men~     that will empower them to take part in decision-making regarding prostate cancer screening~     (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to~     be delivered in primary care settings with attention to patient/provider interaction.~     Funding for this study comes from the National Institute of Health/National Cancer Institute~     (1R21CA178296).~   "
20611|NCT02787421|"~     In this study, the study team will investigate the validity and role of nasal dilator strips~     (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the~     pre-operative evaluation. The method involves placing the strip sequentially at the upper~     and lower lateral cartilage and recording the location of the optimal airway based on~     patient's subjective symptoms.~      Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based~     on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness~     (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before~     and after the operation and comparing these scores.The results will help determine the~     effectiveness and predictive value of NDS in isolating the site of NVC.~   "
20612|NCT02787408|"~     The purpose of the study is to assess the safety and device performance of the Edwards~     Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic,~     tricuspid regurgitation who are at high surgical risk for standard tricuspid~     repair/replacement.~   "
20613|NCT02787395|"~     Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent~     dislocations. Following a first dislocation recurrence rates of up to 80% have been~     reported. Many patients will seek medical assistance for reduction of the shoulder after~     each of these recurrent dislocations. The investigators describe the results of reduction of~     anterior glenohumeral dislocation using a modified self manipulated Milch technique that can~     be performed by the patients themselves after simple guidance and demonstration. This method~     is directed to patients who are not willing or cannot have surgical stabilization and may be~     in a place where medical assistance is not available.~   "
20616|NCT02787356|"~     The purpose of this study is to (1) collect trained observer scores and digital images of~     skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance~     of an automated system for predicting scores directly from the digital images~   "
20641|NCT02787018|"~     The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as~     an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of~     block and duration of analgesia, so that the investigators can choose the better adjuvant~     for the investigators routine practice of regional anesthesia.~   "
20617|NCT02787330|"~     The psychosocial effects of childhood cancer and its demanding medical treatment can affect~     not only the ill child but the whole family, particularly siblings who are often overlooked~     given the terrible circumstances these families face. Current evidence suggests that~     negative long-term psychosocial effects of childhood cancer may be more severe in siblings~     than in the child with cancer. Addressing these effects on siblings may benefit the child~     with cancer and the entire family. Thus, early psychosocial preventive interventions are~     needed to foster psychosocial adjustment in siblings and promote better quality of life for~     the entire family. The immediate objective of this study is to address siblings'~     psychological distress by assessing feasibility and efficacy of a manualized group~     intervention for siblings of children with cancer (Siblings Coping Together, SibCT). A~     longer term objective is that the evidence-based intervention could then be exported to~     other centres across Canada and internationally. Additionally, the study results will~     identify biomedical, personal, familial and social determinants of intervention outcomes~     that can guide clinical effort for those at greatest risk. Finally, the overall aim of the~     project is to reduce psychological distress and improve quality of life for siblings and~     families impacted by a cancer diagnosis and its demanding treatment.~   "
20618|NCT02787317|"~     Prolonging infusions may decrease myocardial damage associated with bivalirudin use during~     primary PCI. The investigators hypothesized that continuing the bivalirudin infusion~     commenced during the procedure at the PCI recommended dose for 4 hours would prevent~     myocardial damage.~   "
20619|NCT02787304|"~     The purpose of this study is to determine if the investigational treatment volixibat~     (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis~     (NASH).~   "
20620|NCT02787291|"~     To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse~     VR ICD in an MRI environment.~   "
20621|NCT02787278|"~     The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1,~     stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA~     for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving~     rtPA standard of care.~   "
20622|NCT02787265|"~     This is a prospective, multi-center, observational follow-up study observing the~     effectiveness of high density spinal cord stimulation in patients with failed back surgery~     syndrome patients with back and leg pain.~   "
20623|NCT02787252|"~     The purpose of this study is to observe the efficacy of stimulation on over all pain relief~     as reported in an initial cohort of 6 patients treated with the Freedom High Frequency~     Spinal Cord Stimulator (SCS) System for low back and/or leg pain.~   "
20624|NCT02787239|"~     Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the~     Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in~     Previously Untreated Subjects With CD20+ DLBCL~   "
20625|NCT02787226|"~     Total shoulder replacement is associated with considerable postoperative pain. A common~     method to treat and prevent this post operative pain is to place a catheter in the neck and~     leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine~     directly to a major nerve near your shoulder. It is very effective at stopping pain. In~     addition to preventing pain, it also prevents movement of the arm because it blocks the~     nerve completely.~      A newer method of treating post operative pain uses only a series of small injections into~     the joint, skin, and muscles of the shoulder near the end of the surgery. This medication,~     liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but~     does not require a catheter to remain in place and does not prevent patients from moving~     their arm after surgery because it only blocks the pain portion of the nerve. Both methods~     also frequently include the addition of oral and injected pain medicines like narcotics to~     effectively control the pain.~      Ropivacaine and Exparel both work well for postoperative pain after total shoulder~     replacement. It is not known, however, if one method is superior in its ability to~     treat/prevent pain or which method may have fewer side effects. The purpose of this study is~     to randomly assign patients to receive either a catheter with ropivicaine or Exparel~     injections to help determine if one method is superior in pain relief and if either method~     has fewer side effects.~   "
20626|NCT02787213|"~     Prospective multicenter observational study to further develop and validate a preterm birth~     risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks~     gestation. A single maternal peripheral blood sample will be collected for analysis. Data~     related to potential risk factors for preterm birth will be obtained through maternal~     interview and review of medical records. Subjects will be followed through the delivery~     process to assess the course of pregnancy, labor, and to document any related maternal~     complications. Neonatal outcomes will be gathered from the medical record for up to 28 days~     of life or discharge, whichever occurs first.~   "
20627|NCT02787200|"~     This study aims to identify various time-variant and time-invariant components of EEG~     signals using advanced signal processing techniques, such as machine learning. The~     investigators' ultimate goal is to develop universal or customised brain-computer interface~     that are stable across days or even years.~   "
20628|NCT02787187|"~     The purpose of this study is to compare outcomes of patients undergoing standard or extended~     lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer~   "
20629|NCT02787174|"~     Asthma is common in children and impacts their health. There are effective medications for~     improving asthma, but some families have difficulty using medicines on a regular basis. This~     study in the emergency department will improve medicine use for children 2-12 years-old with~     asthma.~      The investigators have used focus groups to get ideas from parents of children with asthma~     to best design the intervention. This has helped us create the questions that are being used~     in the intervention, and make the computer program appealing and acceptable to parents of~     children with asthma.~      The investigators will study the success of the intervention for children who receive it~     compared to children who obtain routine emergency department care. Participants who receive~     the intervention will complete a series of questions on a tablet computer. Questions will~     guide creation of individualized education and advice to improve medication use for each~     participant. The intervention will also allow for customized communication with each child's~     primary care provider. The investigators will include educational boosters at 2 and 4 weeks~     after the intervention delivered as chosen by the participant (email / text / RSS / mail).~     Children in the routine asthma care arm will not receive the intervention, and instead will~     receive routine discharge instructions by the emergency room doctors.~      The investigators will compare the success of the intervention group to routine emergency~     department care by using a device (DOSER CT) that measures daily administered doses of~     medicine. Data from the DOSER CT will be collected monthly at home visits for three months.~     The investigators will also measure health care use and quality-of-life for each child using~     a survey at these home visits. The investigators believe that the intervention will improve~     doses of medicine given, reduce unnecessary health care use, and improve children's quality~     of life.~   "
20631|NCT02787148|"~     Prospective studies indicate that patients with depression are at increased risk for~     cardiovascular disease. Depression is also associated with a number of hemodynamic features,~     which are known risk factors for cardiovascular morbidity such as increased heart rate,~     reduced heart rate variability and blood pressure alterations. These hemodynamic alterations~     may explain in part the increased cardiovascular risk associated with depression.~      The purpose of this study is to determine whether treatment for depression with cognitive~     behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors.~     Hemodynamic assessments including heart rate, heart rate variability, continues blood~     pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular~     resistance will be conducted at baseline, after treatment and 2-month follow up. In~     addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal~     blood pressure dipping and immunological biomarkers will be assessed. One-hundred patients~     with Major Depression will be randomly assigned to either a CBT treatment condition (14~     hour-long, weekly sessions) or a waitlist condition, to control for potential changes in~     hemodynamic parameters without any intervention and the impact of repeated-measurement.~   "
20632|NCT02787135|"~     The aim of the present single-blind randomized-controlled therapy study is to assess the~     efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion~     regulation, improvement of self-esteem and sleep quality (CBTd-E).~   "
20633|NCT02787122|"~     The present study is a pilot single-blind randomized controlled therapy study. Its aim is to~     assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses~     on emotional processes that are involved in the formation and maintenance of delusions such~     as emotional stability, emotion regulation and self-esteem.~   "
20634|NCT02787109|"~     The present trial is a phase I first in human, double blind, parallel and placebo controlled~     trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant~     system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in~     the United Kingdom.~      Subjects are randomly assigned to one of the following three treatment groups in a ratio of~     3:3:1.~      This trial consisted of 10 visits and 5 telephonic interviews~   "
20635|NCT02787096|"~     Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is~     difficult. Standard MRI may be used but is of limited diagnostic value. The present study~     aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI~     for the diagnosis of ACL tear.~   "
20636|NCT02787083|"~     Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose~     and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort)~     perceived to be related to the urinary bladder and associated with lower urinary tract~     symptoms for at least 6 weeks duration, in the absence of infection or other identifiable~     causes. Pain is the universal symptom, but many also experience symptoms of overactive~     bladder, possibly directly related to the mechanism of pain. Treating pain may influence the~     symptom of urgency, if the urge arises from a need to alleviate pain. In some patients whose~     pain improves with treatment, troubling overactive bladder symptoms still remain. Beta-3~     adrenergic agonists have been found to decrease signaling of C-fibers in animal models. So,~     the investigators hypothesize that mirabegron, which is FDA-approved for treatment of~     overactive bladder, would also improve symptoms in patients with BPS/IC. As a selective~     beta-3 agonist, mirabegron acts on the beta-3 receptors found in the bladder which mediate~     relaxation of the detrusor muscle. It has been shown to significantly decrease the number or~     micturition episodes, urgency episodes, and increased mean volume of urine voided per~     micturition. It also has a favorable tolerability profile.~   "
20637|NCT02787070|"~     Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an~     acute infection. Recurrent infections can be associated with a febrile illness, a cumulative~     risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after~     both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we~     have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day~     regimen. In Papua a retrospective study found very low effectiveness for unsupervised~     treatment. If true this has profound effects on treatment policy, suggesting that greater~     efforts are needed to encourage adherence to treatment.~      We propose a cluster randomized, controlled, open label trial to assess the effectiveness of~     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.~     Since the risk of recurrent P. vivax is high in patients with either P. vivax or P.~     falciparum, both infections will be included in the study. The study will be conducted in~     Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at~     village health posts and provided with schizontocidal treatment plus primaquine radical cure~     which will be either supervised or unsupervised depending on which cluster the clinic is in.~     Participants will be followed up for 6 months and assessed in regular intervals for the~     presence of patent and sub-patent malaria. The outcome of the study will contribute to an~     improved treatment scheme for uncomplicated malaria in this area.~   "
20638|NCT02787057|"~     Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative~     organisms was recommended as first-line regimen for the management of peritoneal dialysis~     related peritonitis. Oral administration of quinolones can also achieve effective serum~     concentrations, and is more convenient and economical. We conducted a pilot randomized~     controlled study to compare the effects on peritonitis cure and relapsing rates between oral~     moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.~   "
20639|NCT02787044|"~     INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce~     cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine~     in high-risk cardiovascular patients with a recent history of myocardial infarction or heart~     failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three~     additional influenza seasons. The primary endpoint will be a composite of all-cause~     mortality or cardiopulmonary hospitalization.~   "
20640|NCT02787031|"~     The investigators will use health administrative data to examine the variation of anesthesia~     type for hip fracture surgery, as well as sources of variation and predictors of variation.~   "
20650|NCT02786901|"~     Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment~     of Ocular Inflammation and Pain Following Cataract Surgery.~   "
20642|NCT02787005|"~     This is a study of pembrolizumab (MK-3475) in participants with metastatic~     castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based~     chemotherapy. Participants will be enrolled into one of three cohorts: Cohort 1~     (participants with programmed cell death ligand 1 [PD-L1]-positive, measurable disease),~     Cohort 2 (participants with PD-L1 negative, measurable disease), or Cohort 3 (participants~     with bone-metastases and non-measurable disease)~   "
20643|NCT02786992|"~     This prospective randomized double-blind clinical trial will be conducted at Ain-Shams~     University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment~     cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol~     following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100~     ug carbetocin intravenous after cord clamping.~   "
20644|NCT02786979|"~     The objective was to evaluate the efficacy and safety of combination of beraprost and~     aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.~   "
20645|NCT02786966|"~     Each year, half a million patients with a potential neck (c-spine) injury are transported to~     Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck~     bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries~     usually occur at the time of initial trauma and not during transport to the ED. Currently,~     paramedics transport all trauma victims (with or without an injury) by ambulance using a~     backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours~     until an ED bed is made available or until x-rays are completed. Importantly, long~     immobilization is often unnecessary, it causes patient discomfort and pain, decreases~     community access to paramedics, contributes to ED crowding, and is very costly.~      The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma~     patients. This decision rule helps ED physicians and triage nurses to safely and selectively~     remove immobilization, without x-rays and missed injury.~      The investigators will evaluate the possibility and benefits of allowing paramedics to use~     the CCR in the field in 12 new communities from across Ontario. Patients have suggested the~     investigators include measures of pain and discomfort from being immobilized during~     transport as important patient-centred outcomes. The investigators will also measure the~     impact on the ED, and how much money could be saved if more paramedics were allowed to use~     the CCR. The investigators will also assess if sex, age, language barriers, or living far~     from the hospital (long transport time) will affect the outcomes of the study.~   "
20646|NCT02786953|"~     Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and~     suboptimal glycemic control, and novel approaches are needed to improve outcomes in this~     high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8~     hours/night), and sleep disturbance has been significantly associated with poorer adherence~     and predicted greater problems with quality of life and worse glycemic control. Yet, no~     interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and~     contextual model of sleep, the investigators propose to tailor a sleep-promoting~     intervention to meet the needs of adolescents with T1D by conducting interviews with to~     identify the barriers and facilitators to adequate sleep specific to this population. The~     sleep-promoting intervention will be developed and tested, building on successful sleep~     interventions in other populations, including components such as limiting caffeine,~     establishing a media curfew, and positive bedtime routines, while addressing the needs~     unique to adolescents with T1D, such as fear of hypoglycemia. The study will be conducted by~     a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric psychologist, and two~     co-investigators, Beth Malow, MD, MS, a neurologist with specialty in sleep medicine, and~     Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially modifiable risk factor~     that may have both a physiological and behavioral impact on diabetes outcomes. Given the~     strong associations between sleep and diabetes outcomes in the preliminary data, and recent~     evidence from sleep restriction studies indicating the impact of insufficient sleep on~     insulin sensitivity, behavior, and mood, there is reason to believe that a sleep-promoting~     intervention has the potential to improve outcomes in adolescents with T1D indirectly by~     improving adherence and directly through its effect on metabolic function. Therefore, the~     proposed study offers a novel approach to improve adherence, quality of life, and glycemic~     control in adolescents with T1D.~   "
20647|NCT02786940|"~     2-3% of emergency department (ED) syncope patients suffer arrhythmia/death within 30-days of~     disposition (either as inpatient or at home) and the investigators recently developed the~     Canadian Syncope Arrhythmia Risk Score (CSARS) to predict these outcomes. Currently, only~     holter monitoring is used and is applied a few days later. New and innovative remote~     (out-of-hospital) external cardiac monitoring technology has made prolonged monitoring~     possible with live automatic and patient triggered cardiac rhythm transmission to a central~     monitoring station.~      Objective: To conduct a multicenter two-arm open label RCT among higher-risk (CSARS score≥3)~     ED syncope patients discharged home for comparing the diagnostic yield (detection of serious~     arrhythmias that required treatment or exclusion of arrhythmia) at the end of 15-days~     between a 15-day event monitor (intervention) and usual care (48-hour holter with patients~     seeking care after 48-hours based on symptoms) at 10 Canadian EDs.~      Methods: Cardiophone (live monitor) will be used for the intervention arm and the Mobile~     Cardiac Telemetry (MCT) device will be used for the control arm and both devices applied~     prior to ED discharge. MCT will function as a holter for first 48-hours and then as an event~     recorder (days 3-15) for arrhythmia surveillance. After written informed consent, patients~     will be randomized 1:1 with allocation concealed by web-based randomization and stratified~     based on the total CSARS scores. All patients will be linked to a study cardiologist and~     will have follow-up after 15-days. If serious arrhythmias are detected by Cardiophone, the~     patient will be transported to ED and for non-serious arrhythmias, an interim report sent to~     the study cardiologist for follow-up. All monitoring reports will be sent to the~     cardiologist within 24-hours of completion. Data collection: patient demographics, medical~     history, score predictors, device data (failure, false alarms, duration worn), patient~     symptoms and comfort. Primary outcome will be diagnostic yield at 15-days in the two study~     arms and primary analysis will compare the diagnostic yield by intention to treat principle~     controlling for the stratification factor. Sample Size: 300 patients per arm (600 total) to~     detect a 10% difference in diagnostic yield between the arms.~      Impact: Our study will increase early identification of patients with serious underlying~     arrhythmia by combining the CSARS risk tool with innovative remote monitoring technology.~   "
20648|NCT02786927|"~     This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in~     subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific~     preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER~     DPI. The primary objective of this study is to evaluate whether more subjects with COPD~     prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take~     medication.~      All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding~     treatment periods based on the randomisation scheme, and at the end of 2 periods, complete~     the inhaler preference questionnaire. Subjects will self-administer the inhalation once~     daily for 5-9 days in each treatment period.~      This study will be placebo-only, and neither inhaler will contain active treatment. Subjects~     will continue their current COPD medication(s) as prescribed, and will follow up with their~     regular physician for their COPD healthcare during the study.~      Approximately 211 subjects will be enrolled in the study.~      ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark~     of Boehringer Ingelheim International GmbH.~   "
20649|NCT02786914|"~     Patients with suspected tree-nut or sesame allergy based on sensitization on skin-prick~     tests (SPT), will be assessed for allergy using component analysis and basophil activation~     test (BAT) and entered into oral immunotherapy (OIT). Component analysis and BAT will be~     repeated after completion of OIT.~   "
20651|NCT02786888|"~     Early ambulation after knee replacement surgery is made possible in large part by providing~     safe and effective pain control. Peripheral nerve blocks are increasingly used for~     postoperative analgesia since they can provide excellent pain relief and minimize the need~     for opioid analgesics.~      Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists~     at the University of Utah. This block is unique in that it spares motor function in the~     lower extremity. Since 2009, a number of publications have described the successful use of~     ACB for pain management after total knee arthroplasty (TKA), anterior cruciate ligament~     (ACL) reconstruction, and other procedures of the knee. As a component of multi-modal~     analgesia, ACB can provide effective postoperative pain control and facilitate early~     hospital discharge.~      Although it is widely utilized, the ACB block can be technically difficult to perform since~     it requires injection in immediate proximity to the femoral artery and vein. In patients~     with a large thigh circumference, ultrasound can be challenging since the femoral vessels~     are deeper and more difficult to visualize. This presents the possibility of vessel trauma~     and/or intravascular injection of local anesthetic.~      The investigators have implemented a new technique for performing the ACB. This block is~     performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve~     block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm.~     Injection through the fenestrated needle produces effective distribution of local anesthetic~     to nerves of the adductor canal without immediate proximity to the femoral artery and vein.~     The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible~     even in patients with very large thigh circumference.~      In summary, early experience with the US guided ACB block performed with a fenestrated block~     needle suggests that it is technically easier and potentially safer to perform than blocks~     performed with a conventional needle.~      This study should be performed prospectively in order to ensure accurate data comparing the~     two needles. A retrospective review of blocks performed using a conventional needle would~     not provide accurate data with respect to the number of attempts, time required to perform~     the blocks or the resulting sensory changes after performing the nerve block.~   "
20652|NCT02786875|"~     The purpose of this study is to reduce breast cancer recurrence and hence increase~     disease-free survival through a lifestyle program that includes a low glycemic diet,~     physical activity and vitamin D supplementation in women with breast cancer living in a~     Mediterranean country.~   "
20653|NCT02786862|"~     Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of~     anaesthetic and intensive care management. At present, the sole method of improving gas~     exchange restricted by ventilation/perfusion mismatching is independent ventilation with two~     ventilators. Recently, however, a unique device has been developed, enabling ventilation of~     independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to~     evaluate the device's utility, precision and impact on biomechanical lung parameters during~     thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to~     measure the gas distribution in supine and lateral decubitus position.~   "
20654|NCT02786849|"~     The objective of this study will be to evaluate the effects of neuromuscular electrical~     stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on~     peripheral muscle strength, exercise capacity and muscle change and inflammation markers in~     patients with chronic kidney disease (CKD).~   "
20655|NCT02786836|"~     The ALF-MBT protocol is for a multicenter, open label, non-randomized study to determine the~     value of Breath Identification® (BreathID®) Acute Liver Failure 13C-Methacetin Breath Test~     System in predicting the outcome of patients diagnosed with acute liver failure who meet~     inclusion/exclusion criteria.~      Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed~     one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin~     solution (test substrate).~      The Breath Test will be performed on all patients upon admission into the study (Day 1) and~     repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test~     continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the~     improvement or deterioration in liver metabolic function about improvement or deterioration~     in liver metabolic function.~      Patients will be contacted for the Day 21 follow up (21 days after enrollment into the~     trial) to determine spontaneous survival, transplantation and occurrence of serious adverse~     events since the patient's last study treatment.~   "
20656|NCT02786823|"~     This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on~     Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be~     divided into 4 groups of 20 each.~        -  Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral~          anti-diabetic drugs;~        -  Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral~          anti-diabetic drugs;~        -  Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily~          for 8 weeks along with standard oral anti-diabetic drugs;~        -  Group D: to receive no additional intervention apart from standard oral anti-diabetic~          drugs.~      The biochemical parameters will be evaluated before and after the intervention.~   "
20657|NCT02786810|"~     The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal~     ultrasound.~   "
20658|NCT02786797|"~     The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress~     reduction intervention, in order to determine its efficacy in improving cognitive~     functioning among breast cancer survivors. The study will employ a three group randomized~     design that will (1) evaluate the extent to which MBSR(BC) compared to the Breast~     Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning~     among breast cancer survivors off treatment; (2) determine if improvements in cognitive~     functioning achieved from MBSR(BC) are mediated through increased mindfulness and decreased~     rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC) on~     improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization and~     costs, in addition it will be delivered to a sub-group in Spanish. If shown to be~     efficacious, the possibility exists of utilizing this intervention in other types of cancers~     as well as non-cancer health-related disorders in order to minimize the morbidity~     experienced by these populations.~   "
20670|NCT02786641|"~     The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of~     docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced~     nasopharyngeal carcinoma.~   "
20671|NCT02786628|"~     The primary objective of this study is to assess the feasibility of a multi-institutional~     study that collects cardiopulmonary exercise testing and 6 minute walk distance performance~     testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient~     generated health data (wearable activity monitors and patient reported outcomes) for the~     subsequent month. In addition to demonstrating feasibility, the study looks to generate~     preliminary data that supports the capacity of physical performance testing and~     patient-generated health data to complement clinician-rated performance status in patients~     receiving chemotherapy.~   "
29899|NCT02665741|"~     The goal of this study is to compare two FDA approved distal colonoscope attachment devices,~     in order to identify which device can increase adenoma detection rate the most without~     increasing procedure time or risk.~   "
20659|NCT02786784|"~     Patellofemoral pain (PFP) is the most diagnosed condition in individuals with knee~     complaints. Studies revealed that one third of individuals with PFP suffer from persistent~     complaints, indicating that current treatments fail to prevent the chronicity of symptoms.~     Considering that current treatment-strategies of patients with PFP seem to be unable to~     avoid the development of chronic symptoms, the question arises if the underlying factors of~     PFP are understood sufficiently. Current research focuses predominantly on muscle strength~     assessment by means of a maximum voluntary contraction (MVC), even though, weakness might~     not only be caused by a reduced voluntary contraction but also by an involuntary ability to~     contract the muscle fully, which is named arthrogenous muscular inhibition (AMI). Although~     AMI has been proven to be present in a wide range of knee joint pathologies to date it~     remains unclear whether patients with PFP are weak or inhibited. It remains also unclear if~     there exists a causal link between AMI and biomechanical alterations.~      Previous studies investigated the influence of exercise treatment on muscular strength,~     function and pain. However, to date no study investigated the influence of the currently~     recommended exercise treatment on AMI. Thus, the analysis of the effect of a 6 week exercise~     treatment might yield further insights if a specific exercise treatment can reduce AMI,~     improve functional performance and reduce pain.~      Methods: The investigators will invite 40 participants with PFP and 40 healthy controls to~     take part in the study. As a basis investigation kinematic, kinetic measures, and surface~     electromyographic (sEMG) of 4 lower limb muscles will be taken during functional tasks.~     Muscle strength and AMI of the quadriceps, muscle flexibility, and a posture assessment of~     the patella as well as the foot will be carried out. All participants with PFP will then~     receive a 6 week exercise programme to follow. After six weeks, the participants with PFP~     will attend the Salford university, where they will be reassessed.~      Expected outcomes: The study will investigate if AMI is present in participants with PFP and~     if AMI is directly linked to functional performance. In addition this study will investigate~     if a specific exercise treatment can reduce AMI and improve functional performance.~   "
20660|NCT02786771|"~     The goal of this study is to evaluate the effectiveness of Spire and Muse on stress~     management. The study will be implemented as a 2-arm randomized controlled pilot study to~     assess the effect of either device on stress management from the end of baseline to~     closeout.~   "
20661|NCT02786758|"~     This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV)~     in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay~     and bisexual men by treating prevalent infection, thereby reducing new primary infections~     and re-infection.~   "
20662|NCT02786745|"~     To find out the safety and effectiveness of dapsone.~   "
20663|NCT02786732|"~     The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance~     Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to~     severe plaque psoriasis.~   "
20664|NCT02786719|"~     Patients will be asked to participate in this study because patients have been diagnosed~     with high-risk neuroblastoma, a common childhood cancer which has aggressive features. If~     left untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma~     often respond to current available treatments, but there is a high risk that the cancer will~     return.~      This study will test the safety of giving standard induction treatment for high-risk~     neuroblastoma without one of the drugs commonly used to prevent side effects. Current~     treatment for high-risk neuroblastoma includes anti-cancer drugs (chemotherapy), surgery,~     radiation therapy and high-dose chemotherapy with hematopoietic stem cell rescue. Treatment~     takes about one year to complete and occurs in 3 phases: induction, consolidation, and~     maintenance. This study is limited to the induction phase of treatment.~      Induction therapy includes six chemotherapy drugs given in different combinations every 3~     weeks for a total of 6 courses. For the past decade, induction chemotherapy has been~     followed by a drug called granulocyte colony stimulating factor (G-CSF, filgrastim,~     peg-filgrastim, Neupogen, or Neulasta) to prevent side effects from the chemotherapy. G-CSF~     is routinely given to patients with high risk neuroblastoma after chemotherapy to stimulate~     white blood cell production and shorten the time period when the absolute neutrophil count~     (ANC), a type of white blood cell, is low after chemotherapy. G-CSF is known to shorten the~     period of low ANC by approximately 3 days. When the ANC is lowest, a patient is most at risk~     of getting a bacterial infection.~      Recent lab experiments in mice have shown that neuroblastoma tumor cells may respond to~     G-CSF by growing faster and metastasizing (spreading to other parts of the body). There have~     been no clinical trials comparing the survival of children with high risk neuroblastoma with~     or without G-CSF. This clinical trial is the first step towards giving induction~     chemotherapy with less G-CSF.~      The goal of this study is to determine if it is safe to give induction chemotherapy to~     children with neuroblastoma without giving G-CSF routinely.~   "
20665|NCT02786706|"~     Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised~     Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD)~     threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in~     clinical practice. The investigators goal is to develop and validate an automated image~     analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients~     with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with~     blinded ONSD measurement by an expert investigator. The image analysis algorithm will then~     be used to measure ONSD and accuracy determined compared to the reference standard expert~     measurement.~   "
20666|NCT02786693|"~     Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are~     two frequent causes of hospitalization or consultation in infectious disease unit and~     internal medicine.~      There are many etiologies, in four categories: infections, auto-immune disease, cancer and~     miscellaneous causes. Currently there is no specifics recommendations to follow a diagnosis~     way of FUO and SII.~      Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic~     inflammatory syndrome of unknown origin, in two units of the University Grenoble Hospital.~   "
20667|NCT02786680|"~     A large body of evidence points to impairment in the decoding of emotional stimuli in~     Parkinson's disease (PD). These changes seem to be related to dysfunction of the~     mesocorticolimbic projections leading to dysfunction of the limbic cortico-subcortical loop~     that, throughout the basal ganglia, projects to limbic cortical regions such as the anterior~     cingulate cortex and the orbitofrontal cortex, which are known to be involved in emotional~     processing. Thus, presumably the occurrence of non-motor psychic symptoms and fluctuations~     in PD would also rely on the degeneration of this circuitry. Dopamine modulation of emotions~     has been frequently reported both in healthy subjects or PD patients, but the effect of~     subthalamic nucleus deep brain stimulation (STN-DBS) over mood symptoms is more~     controversial and there is still a paucity of data demonstrating its role in emotional~     processing. The objective of our study is to assess and compare the behavioral and~     electrophysiological effects of both dopamine and STN-DBS in PD during emotional processing.~     To do so, the Emotional Stroop task, a version of the classical Stroop test developed to~     investigate inhibition of emotional interference, will be performed by STN-DBS PD patients~     in four different treatment conditions while high resolution electroencephalographic~     cortical mapping is conducted. Using this approach, the investigators expect to better~     separate the mechanisms of psychic features related to either disease, dopaminergic~     treatment, subthalamic stimulation or the association of both, with the final aim of~     optimizing the clinical management of PD.~   "
20668|NCT02786667|"~     Clinical description and pathophysiological study of recently diagnosed untreated patients~     with Parkinson's Disease.~      Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson~     disease: A controlled, randomized, double blind study.~   "
20669|NCT02786654|"~     The aim of the study is to investigate the association between the use of β blockers and~     mortality among hospital survivors of acute myocardial infarction without heart failure.~   "
20672|NCT02786615|"~     This study addresses the disproportionate representation of men who have sex with men (MSM)~     in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic~     in Kazakhstan, a country that has seen some of the largest growth in new HIV infections~     since the turn of the century. Using a stepped wedge trial across 4 cities in Kazakhstan,~     the proposed study will test a strategic and innovative social network-based intervention~     for MSM who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV~     continuum of care as well as services that address issues that co-occur with HIV, including~     drug abuse, Hepatitis C Virus (HCV) infection, and other sexually transmitted infections.~   "
20673|NCT02786602|"~     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the~     third most common cancer in incidence and mortality in France. The vast majority of these~     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:~     adenoma. All CRC with the same disease stage do not have the same prognosis. Various~     parameters have been identified as factors influencing the prognosis and allows adjustment~     of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the~     tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of~     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF~     mutation is an independent poor prognostic factor.~      The different molecular pathways of colonic carcinogenesis are the chromosomal instability~     pathway, the microsatellite instability pathway inducing errors in DNA mismatch repair and~     the CpG Island Methylator Phenotype (CIMP). The hypermethylation of CpG islands of genes~     promoters leads to an over or most frequently under gene expression. CIMP is observed in~     near 15% of CRC and is associated with specific clinical and pathological features: older~     patients, female predominance, right colonic involvement, poorly differentiated or mucinous~     adenocarcinomas. From a molecular point of view, the high CIMP phenotype is strongly~     associated with the presence of BRAFV600E mutation, the absence of RAS mutation and the~     presence of microsatellite instability. The prognostic value of CIMP is actually~     controversial. A recent meta-analysis found that the CIMP phenotype was associated with a~     poor prognosis. Methylation of some genes promoters as CDKN2A is associated with a poor~     prognosis.~      LRP-1 (low density lipoprotein receptor-related protein 1) is a multifunctional endocytic~     receptor that belongs to the LDL receptors the family. It mediates the clearance of many~     extracellular enzymes involved in the spread of cancer cells: metalloproteinases and serine~     proteinases. Decrease of LRP-1 activity or loss of LRP-1 expression correlates with~     increased aggressiveness of cancer cells in certain types of cancer. The expression of LRP-1~     has almost never been studied in CRC. Only one immunohistochemical study of LRP-1 protein~     expression in colonic adenocarcinoma has been published to date. This study shows that tumor~     cells express LRP-1, but in nearly half the cases, weaker than in normal cells colic. The~     mechanisms involved in the decrease of expression are not known.~      An epigenetic mechanism might be involved as hypermethylation of the of LRP-1 gene promoter,~     especially as the promoter of this gene is rich in CpG islands (methylation targets).~     Clinical and prognostic significance of the LRP-1 gene expression and promoter methylation~     is actually unknown.~   "
20674|NCT02786589|"~     The objective of this study is to evaluate the safety and the effectiveness of Plasmodium~     immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung~     cancer~   "
20675|NCT02786576|"~     This study will assess the effects of adalimumab treatment in moderate to severe~     Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this~     study are to estimate the effectiveness of adalimumab treatment on disease severity, to~     estimate the impact of adalimumab treatment on patients' quality of life, psychological~     effect, work productivity and healthcare resource utilization and to describe treatment~     practices over the study period.~   "
20676|NCT02786563|"~     Prospective, post-marketing, multi-center, open-label study to explore if the initiation of~     adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US)~     score using 36-joint plus 4-tendon scoring system, and validate the applicability of~     different simplified US joint scoring systems.~   "
20677|NCT02786550|"~     The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle)~     and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty~     incision whereas the scar is more visible on patient.~      The main aim of this trial is to investigate whether the injection of Botulinum toxin into~     the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower~     blepharoplasty.~   "
20678|NCT02786537|"~     Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to~     learn whether they work equally well under real-world conditions. Phase 2 of this study will~     begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments.~     Patients receiving HCV therapy in community and academic clinics will be offered the~     opportunity to consent to be randomly assigned to one of three regimens and then observed~     for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side~     effect management will be assumed by usual care conditions, and patient-reported outcomes~     will be collected outside clinic in keeping with pragmatic design principles.~   "
20679|NCT02786524|"~     To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic~     improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy~     patients compared with symptom management performed by the primary gynecologic oncologist.~   "
20680|NCT02786511|"~     This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up~     study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study,~     that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B~     cell maturation antigen (BCMA)-expressing multiple myeloma.~      bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02~     CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA~     suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or~     retreated if retreatment criteria are met) in parent clinical study. No investigational~     treatment will be administered in this study.~      After completing the parent study, eligible subjects will be followed for up to 15 years~     after their last bb2121 infusion in the parent study.~   "
20681|NCT02786498|"~     The objective is to determine the effect of vitamin D3 supplementation on fracture healing~     at 3 months.~   "
20682|NCT02786485|"~     This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor~     BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with~     recurrent disease minimal residual disease (MRD) post-allogeneic transplant.~   "
20683|NCT02786472|"~     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of~     bystander training elements (delivery mode and integration of substance abuse prevention)~     among cohorts of incoming undergraduates at the University of Kentucky, a nationally~     recognized leader in addressing sexual violence through bystander intervention programming.~     Consenting students will be randomized to one of the following training conditions:~        1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training~          (GreenDot);~        2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse~          Prevention Training;~        3. Online Bystander-based Sexual Violence Prevention Training (Haven), and;~        4. Online Substance Abuse Training (AlcoholEdu).~   "
20684|NCT02786459|"~     An exploratory, feasibility and proof-of-concept study to evaluate the capability of a~     rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical~     agent (ProstaScintÂ®; as a surrogate marker for prostate cancer) in patients who have~     undergone a radical prostatectomy for their disease, patients with multiple negative~     prostate biopsies and patients with known primary prostate cancer. Developed by Hybridyne~     Imaging Technologies, Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact~     gamma camera. It is the same size as a trans-rectal ultrasound (TRUS), currently used for~     prostate biopsy guidance. Men with multiple positive biopsies will be considered controls.~     Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS,~     MRI and SPECT/CT. The investigators hypothesize that it will be safe and feasible to utilize~     a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScintÂ®, thus~     identifying and localizing the tumour sites within the prostate and surrounding areas.~   "
20685|NCT02786446|"~     We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination~     on the pain control during extracorporial shock wave lithotripsy for renal stones.~   "
20686|NCT02786433|"~     Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of~     dopaminergic neurons that can cause some mobility limitations and it has association with~     quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of~     these patients Objective: Evaluate the functional capacity and QOL of individuals with PD~     using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3,~     aged 50-75 years. They were divided by lot into two groups (control and experimental) with~     ten patients in each. The group (CG) treated with exercises (conventional therapy) during~     five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG)~     spent half the time with conventional physical therapy and other half of time in virtual~     rehabilitation (VR). Subjects were evaluated before and after treatment using the following~     scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .~   "
20687|NCT02786420|"~     How environmental pollution contributes to poor pregnancy outcome is poorly understood. The~     first trimester of pregnancy is a particularly vulnerable time period for the developing~     fetus and a mother's exposure to air pollution may alter the way that the placenta is~     established and how it functions throughout the rest of pregnancy. This project aims to~     expand and develop new MRI technologies to assess real-time placental structure and function~     as pregnancy develops from the first to the third trimester so that early detection,~     prevention strategies, and early treatment of placental dysfunction as a result of pollution~     exposures may be developed.~   "
20688|NCT02786407|"~     This is a multicenter, double-blind, randomized, placebo-controlled study designed to~     evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLi®) in~     patients with overactive bladder (OAB) . Approximately 216 subjects will be enrolled.~     Subjects will be randomized 2:1 to receive intradetrusor injection of Botulinus Toxin Type A~     for Injection (HengLi®) 100 U or placebo. The study contains two parts: core double-blinded~     phase and extension phase. In the core double-blinded phase, eligible subjects must attend~     three study visits posttreatment 12 weeks. During the extension phase, subjects must also~     attend three study visits (12 weeks). The primary efficacy variables is the change from~     baseline in the daily average frequency of micturition at week 6 after the first treatment.A~     3-day paper bladder diary will be used before each study visits (screening period, the~     second week, the sixth week, the twelfth week, the fourteenth week, the eighteenth week and~     the twenty fourth week ) to collect all OAB symptoms (episodes of urgency, incontinence,~     micturition and nocturia) and volume per voidSafety parameters will also be measured,~     including adverse events, vital signs (pulse and blood pressure) and clinical laboratory~     tests (haematology, serum chemistry and urinanalysis).~   "
20689|NCT02786394|"~     The purpose of this study is to test feasibility for the delivery and perceptions of a~     lifestyle model for middle-aged and older adults by involving participants in its~     development. The goal of the program is to reduce sedentary behaviour, increase physical~     activity, and increase strength and balance. An optional walking program will be run in~     parallel to emphasize the importance of moving more. Participants will be asked to fill out~     questionnaires on course delivery, content and effect throughout the program and 2-3~     recorded interviews throughout the study. We will collect measurements of physical~     performance before and after the program.~   "
20690|NCT02786381|"~     This clinical study will collect fresh samples and perform laboratory testing on fresh and~     archived samples as described in the protocol.~   "
20691|NCT02786368|"~     This project is a delayed pragmatic delayed-intervention cluster randomized control study in~     a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead~     food production (EHFP) in Cambodia. The trial is designed to evaluate the impact of EHFP~     (home gardens only; home garden and fishponds; home gardens and poultry) versus control~     group on dietary intake of women and youngest child, household food security, income and~     production throughout the agricultural cycle. Following administration of the baseline~     survey 300 households will be randomized to the EHFP package of their choosing (Intervention~     Group) for two years. The other 300 households will not receive any intervention during the~     first year and will act as the control group; data will be collected monthly on production~     and income generated from gardening (and other HFP activities) and at two points throughout~     the year 24-hour dietary recall data will be collected from the women head of the household~     (aged 15-49y) and the youngest child between the ages of 6 - 59 months. After one year, the~     control group will be offered the intervention (EHFP package of their choice) fully~     subsidized and the project team will collect identical data on intervention group for one~     year as described for the control group.~   "
20692|NCT02786355|"~     We will conduct this study to show that it is possible to ventilate effectively through a~     Frova bougie and an Ambu® bag.~   "
20693|NCT02786342|"~     Sorafenib represents the standard care for advanced hepatocellular carcinoma (HCC). However,~     molecular predictors of sorafenib efficacy have not yet been identified.~      The primary aim of the study is to validate the prognostic or predictive role of eNOS,Ang2,~     HIF-1, VEGF and VEGFR polymorphisms in relation to clinical outcome (progression-free~     survival, PFS) of HCC patients treated with sorafenib.~   "
29900|NCT02665728|"~     The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in~     constipated adolescent subjects.~   "
20694|NCT02786329|"~     Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without~     lidocaine on postoperative short and long term outcome in patients with colorectal cancer~     undergoing surgery.~      As short term endpoints postoperative pain and opioid consumption, resumption of bowel~     function, PONV, LOS will be registered.~      Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer~     recurrences incidence and mortality.~   "
20695|NCT02786316|"~     Low back pain is a common disorder, occurring worldwide in both males and females in all age~     groups1. The prevalence is higher in females and the incidence peaks between 30 and 65~     years. It is currently the most frequent musculoskeletal cause of functional disability and~     it has a major socio-economic impact on today's society. Although a small percentage of~     persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of~     persons with low back pain present with symptoms of nonspecific origin. A part of these~     symptoms are only of short duration, but 23% of all people will develop nonspecific chronic~     low back pain (NSCLBP).~      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.~     Previous studies analysed the effects of various modes of exercise therapy, such as motor~     control therapy, core stability training and aerobic conditioning training. However, therapy~     outcomes can be low, and guidelines in favour of using a specific program are contradictory.~     It thus still remains unclear which therapy modality is best suited. Furthermore, no~     recommendations are available about optimal training intensities during rehabilitation of~     persons with NSCLBP.~      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low~     back pain and improvements in overall physical fitness can affect therapy outcomes in this~     population, ET specifically focussing on physical fitness can be advocated for NSCLBP~     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and~     efficient training method for improving physical fitness and health related parameters in~     healthy persons. Also, HIT resulted in successful reconditioning and improvement of~     functional and disease related outcomes in persons with other chronic diseases such as~     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies~     showed promising results for the effect of HIT on low back pain such as high intensity~     isolated, evidence is still scarce and study results are unclear because of methodological~     shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy~     program was developed consisting of high intensity interval cardio and high load whole body~     strength training.~      The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the~     rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on~     disease related outcomes and physical fitness compared to a conventional rehabilitation~     program in persons with NSCLBP.~   "
20696|NCT02786303|"~     The diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess,~     especially in the detection of metastasis as they can grow in different organs such as~     liver, lungs, bones or lymph nodes. Nowadays, the diagnosis is made with two main imaging~     techniques which are the thoraco-abdomino-pelvic CT-scan and a scintigraphic method~     (Octreoscan and sometimes a TEP-scan). The use of a whole-body MRI is more and more often~     used for the detection and evaluation of tumors and metastases; therefore, it could be used~     for neuroendocrine tumors. The MRI would allow to replace the two imaging techniques and to~     avoid the use of irradiation but also to have a better detection of metastases. This purpose~     of the study was to evaluate this statement by assessing the consistency between the routine~     techniques and the MRI and finally to update the recommendation if the study is positive.~   "
20697|NCT02786290|"~     This is a First in Human study to assess the feasibility, safety and effectiveness of the~     Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia~     (BPH).~   "
20698|NCT02786277|"~     In this trial, individuals with Acute Kidney Injury will be randomized to usual care or to~     an electronic AKI alert system. In three phases, the alert system will be trained to~     identify those most likely to benefit from the alert, and inclusion criteria will be~     modified.~   "
20699|NCT02786264|"~     This study proposes to perform a descriptive analysis and pilot observational study looking~     at the types and quantity of anesthetic agents used and their associations with outcomes~     among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale~     New Haven Hospital (YNHH).~   "
20700|NCT02786251|"~     The recent discovery of functional brown adipose tissue (BAT) in humans has led to a~     paradigm shift in adipose tissue biology; it is now believed that adipocytes may play a~     significant role in regulating substrate metabolism. Given that the resurgence in the~     interest in human BAT is still in its infancy, a number of fundamental questions pertaining~     to the role of BAT in human physiology remain unanswered. One area of particular importance,~     but poorly understood, is the potential effect of BAT on triglyceride (TG) metabolism. Data~     from a series of studies have found that BAT is inversely associated with adiposity, high~     blood lipids, and fatty liver in people. However, the role of BAT in the regulation of TG~     metabolism in people is not known. The overall goal of this study is to determine the~     physiological importance of the human BAT in TG metabolism. To this end, we are planning to~     study forty overweight/obese women with high amounts of BAT (BAT+, n=20) and with no/minimal~     BAT (BAT-, n=20) both under thermoneutrality and mild cold exposure (~2 weeks apart). The~     investigators hypothesize that BAT+ subjects will demonstrate greater plasma very low~     density lipoprotein-triglycerides (VLDL-TG) clearance rate during cold exposure compared to~     BAT- subjects and upregulation of genes and proteins involved in lipid metabolism only in~     BAT (but not muscle and white adipose tissue). Infusion of stable isotope tracers and~     metabolic modeling techniques will be used to assess VLDL-TG kinetics. Positron emission~     tomography computed tomography will be used for the identification and quantification of~     BAT. Supraclavicular BAT, abdominal white adipose tissue, and skeletal muscle tissue~     biopsies during cold exposure and thermoneutral conditions in conjunction with molecular~     biology techniques will used to measure expression of genes and proteins involved in lipid~     metabolism.~   "
20701|NCT02786238|"~     This study will be the first clinical trial to examine the impact of two different weight~     loss interventions on novel mechanisms that promote obesity and impede its successful~     treatment, including cognitive function and self-regulatory factors. The results will~     provide important data about how impaired cognitive function and/or self-regulation promote~     obesity and how different weight loss treatments may differentially impact these factors;~     this information will be used to identify promising cognitive and self-regulatory treatment~     targets for preventing further obesity development and for maintaining weight loss.~   "
20702|NCT02786225|"~     Perinatal outcomes in the US rank behind most other developed countries even though women in~     the US utilize more maternity services. Current approaches to consultation and collaboration~     among perinatal care providers, including nurse-midwives, obstetricians, and~     perinatologists, fragment care resulting in communication errors and maternal~     dissatisfaction. The CARE study will test an innovative interdisciplinary consult visit to~     improve communication, teamwork, maternal satisfaction, and perinatal outcomes.~   "
20711|NCT02786108|"~     The purpose of this study is to evaluate the safety and effectiveness of left gastric artery~     embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is~     blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight~     loss.~      Although there are many ways to treat morbid obesity, surgery is currently the only~     effective method to be confirmed. But surgical treatment is likely to carry a high risk of~     treatment-related complications, such as fistula or intestinal obstruction, etc. This study~     is designed to help treat obesity using a method of transvascular interventional therapy,~     which is minimally invasive and non-surgical.~   "
21517|NCT02775539|"~     The purpose of this study is to evaluate the efficacy and safety of mirabegron (a B3~     adrenergic receptor agonist) in patients with pulmonary hypertension secondary to heart~     failure by conducting a randomized multicenter phase II placebo-controlled clinical trial.~   "
20703|NCT02786212|"~     Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response~     that can often lead to dysfunction of major organs. Activation of the contact system,~     endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of~     inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an~     important role during this process. However, very little is known about the susceptibility~     of the splanchnic organs to ischemic reperfusion injury. Although the incidence of~     intestinal complications reported to be low, the in-hospital mortality in these patients was~     high at 15% to 63%.~      Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of~     other sedative and antinociceptive drugs and provide sufficient sedative effects with~     minimal respiratory side effects. In addition, dexmedetomidine gradually has gained~     popularity in the field of critical care. Preemptive administration of dexmedetomidine has~     shown to be protective against inflammation, intestinal, renal, and myocardial injuries in~     animal and human studies. Dexmedetomidine is also used as an anesthetic adjuvant during~     surgery to offer good perioperative hemodynamic stability and an intraoperative~     anesthetic-sparing effect. Perioperative use of dexmedetomidine can reduce intestinal and~     hepatic injury after hepatectomy with inflow occlusion under general anesthesia. However,~     whether or not it can exert protective effects on the above-mentioned organs, especially~     intestine, after cardiac surgery remains unclear. The aim of this study is to evaluate the~     effects of dexmedetomidine on intestinal, hepatic, and other organ injury in patients~     receiving cardiac surgery with CPB.~      In this double-blinded randomized controlled study, serum diamine oxidase activity, which is~     a sensitive and specific marker for the detection of intestinal injury, is taken as the~     primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung~     injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of~     endothelial injury (endocan) will also be determined. Besides, microcirculation parameters~     measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the~     protective effect of dexmedetomidine on microcirculation. The variables will be collected~     perioperatively and will be followed up for 3 days after the surgery. Clinical outcome~     parameters will be followed up for 3 months after the surgery.~   "
20704|NCT02786199|"~     Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor~     affecting patient survival. It has been divided into four grades from I to IV on the basis~     of histological differentiation. Grade I is the best differentiated consisting of small~     tumor cells arranged in thin trabeculae. Cells with higher grade are larger and less~     differentiated with hyperchromatic nuclei and loss of trabecular pattern.~      Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its~     convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic~     evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot~     replace liver biopsy for the evaluation of HCC.~      This study is aimed to quantify the image characters of B-mode image and the scatterer~     properties using Nakagami distribution. Nakagami parameter is a general model to describe~     the distribution of scatterers. Therefore, the investigators hypothesized that Nakagami~     parameter may also reflect the histological changes in different grades of HCC.~      In this study, the resected HCC tumor samples will be collected from the participants who~     are going to receive surgical resection, and the tumor US images and Nakagami values will be~     obtained via the single-element ultrasound system. The correlation between the ultrasound~     backscatter parameter and the differentiation grade will be analyzed.~   "
20705|NCT02786186|"~     The main purpose of the current study will be to provide real - world evidence regarding the~     safety and effectiveness of secukinumab in the management of patients with moderate to~     severe chronic plaque psoriasis.~   "
20706|NCT02786173|"~     The PRIME Registry is a multi-center, observational study designed to evaluate immediate and~     long-term outcomes (36 months) of endovascular revascularization in patients with critical~     limb ischemia (CLI) and advanced peripheral artery disease (PAD).~   "
20707|NCT02786160|"~     The study is a randomised, placebo-controlled, double-blind, parallel study in obese~     children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood~     obesity treatment program, will be included. The participating children will be randomised~     into one of three groups consuming either HMO (two groups) or placebo (one group).~      The primary objective of the study is to establish the effects of HMOs on the faecal~     microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation~     in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic~     profile and body composition in obese children.~   "
20708|NCT02786147|"~     The purpose of this study is to identify the most effective means of follow-up for women who~     screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the~     standard clinical setting of mammography, to maximize the number who are referred to and~     receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be~     evaluated by determining the number seen who are appropriate for genetic testing, undergo~     genetic testing and are found to carry a hereditary cancer gene mutations with medical~     management implications for the patient and family. The long-term goal is to reduce the~     morbidity and mortality associated with hereditary causes of breast and ovarian cancer among~     patients seen in the Emory/Winship system.~   "
20709|NCT02786134|"~     Coronary flow reserve (CFR, calculated as the ratio of hyperemic over rest myocardial blood~     flow) is emerging as a powerful quantitative prognostic imaging marker of clinical~     cardiovascular risk. CFR provides a robust and reproducible clinical measure of the~     integrated hemodynamic effects of epicardial coronary artery disease (CAD), diffuse~     atherosclerosis, and microvascular dysfunction on myocardial tissue perfusion. Inflammation~     is a key mediator of this constellation of abnormalities, affecting the entire coronary~     vasculature, but no clinical trial to date has shown that directly reducing inflammation~     lowers cardiovascular event rates. As such, the recently launched Cardiovascular~     Inflammation Reduction Trial (CIRT) provides a unique opportunity for mechanistic~     investigation of the impact of anti-inflammatory therapy on changes in CFR as a reflection~     of coronary vascular dysfunction, which may precede clinical outcomes, particularly in~     patients at high-risk of events. The investigators are ideally positioned to examine the~     impact of inflammation on CFR, having extensive experience in both the quantitation of CFR~     using clinically-integrated dynamic positron emission tomography (PET) and the ability to~     assess its association with cardiovascular outcomes. The central hypothesis of this~     ancillary proposal, CIRT-CFR, is that reducing systemic inflammation using low-dose~     methotrexate (LDM) will, compared to placebo, quantitatively improve myocardial blood flow~     and coronary flow reserve as measured by PET over one year, in stable CAD patients with type~     2 diabetes or metabolic syndrome enrolled in CIRT. In so doing, improvement in coronary~     vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on~     myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms~     and prognosis.~   "
20710|NCT02786121|"~     Several authors explain as the kinesiophobia plays an important role for the recovery after~     orthopaedic surgery. The aim of the investigators study is to investigate if the~     kinesiophobia is able to influence the early recovery after total hip arthroplasty. The~     early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will~     measure the fear level of movement. All the other variable that could influence the ILOA~     Score are identified and collected: age, sex, body max index, ability of patient~     pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.~   "
21530|NCT02775370|"~     This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with~     Head and neck metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study~     is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.~   "
20712|NCT02786095|"~     This study is prospective Cohort study which was performed in multicenter (General Hospital)~     in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital.~     The purpose is to analyze complication, composite outcome (all cause mortality,~     hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE))~     according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate~     control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation~     agents (warfarin, coumadin, an NOAC)~   "
20713|NCT02786082|"~     The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and~     providing evidence for clinical study and clinical application of this product.~   "
20714|NCT02786069|"~     The main objective is to evaluate the effect of single dose Propionyl-L-Carnitine~     Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical~     pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis~     for market authorization registration.~   "
20715|NCT02786056|"~     Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in~     regional lung ventilation. The quantitative assessment of structural and functional~     alterations in the lung is of great importance for the phenotyping and follow-up of CF~     patients. The goal of this study is to assess the feasibility of measuring the changes in~     proton density in the lung parenchyma with inflation and deflation during the respiratory~     cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.~   "
20716|NCT02786043|"~     The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on~     clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic~     characteristics and safety on healthy Chinese subjects to provide a basis for market~     authorization registration~   "
20717|NCT02786030|"~     This study will evaluate a complex intervention based on a patient management tool (PMT),~     combined with educational outreach to primary care doctors, nurses and other health workers,~     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality~     of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with~     asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the~     intervention will be assessed by randomly allocating 48 primary care clinics to receive the~     intervention or not, and comparing patient and clinic level endpoints that reflect the~     health and quality of care provided over the following year. About 1250 patients known to~     have been diagnosed with asthma and 700 with COPD in participating clinics and will be~     included in the study. The primary endpoints for patients with asthma and COPD,~     respectively, will be composite scores indicating appropriate prescribing and diagnostic~     testing. The third primary endpoint, among all adult clinic users, will be rates of new~     diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual~     components of the composite scores, health measures (hospital admissions and deaths), and~     indicators of appropriate management of comorbid conditions such as cardiovascular risk~     factors. Eligible patients will be identified and outcomes measured using electronic medical~     records.~   "
20718|NCT02786017|"~     The purpose of this study is to assess the safety and efficacy of injectable collagen~     scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs)~     transplantation in patients with Decompensated Cirrhosis.~   "
20719|NCT02785991|"~     The purpose of this registry is to reflect on standard clinical practice in pulmonary vein~     cryoablation in Spanish hospitals, the different procedure protocols, details of~     intervention, complications, long-term follow-up strategy and results in these subjects.~   "
20720|NCT02785978|"~     Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo~     measured activity in PD patients. The purpose of the study is to provide validation of the~     ActiMyo, an innovative home-recording device enabling use in clinical trials and as an~     innovative tool for PD patient care.~   "
20721|NCT02785965|"~     The purpose of this study is to determine whether the use of electroacupuncture to dredge~     and regulate Dai Meridian combined with lifestyle modification are more effective than~     lifestyle modification only in the treatment of anovulation and hyperandrogenism due to~     polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will~     receive electroacupuncture and lifestyle modification in combination, while the other one~     third will receive lifestyle modification only.~   "
20722|NCT02785952|"~     This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in~     treating patients with stage IV squamous cell lung cancer that has come back after previous~     treatment. This is a non-match sub-study that includes all screened patients not eligible~     for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,~     may be able to shrink tumors. It is not yet known whether nivolumab works better with or~     without ipilimumab in treating patients with squamous cell lung cancer.~   "
20723|NCT02785939|"~     This phase II trial studies how well palbociclib works in treating patients with stage IV~     squamous cell lung cancer that has come back after previous treatment. This is a sub-study~     that includes all screened patients positive for the cyclin dependent kinase 4/6 (CDK4/6)~     biomarker. CDK4/6 can cause tumor cells to grow more quickly. Palbociclib may decrease the~     activity of CDK4/6 and may be able to shrink tumors.~   "
20734|NCT02785796|"~     In osteopathy is generally believed that the cranial bones are equipped with an inherent~     mobility, which like any other joint may face restrictions on movement and then somatic~     dysfunction. For this reason, different techniques are used with the aim of increasing the~     mobility of the cranial bones. Some of these have been effective in modifying physiological~     parameters related to the activity of the autonomic nervous system, such as cardiac function~     or sleep latency. This study aims to test the effectiveness of a specific craniosacral~     technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase,~     which is sensitive to changes in the activity of the autonomic nervous system. To patients~     recruited from students of AIMO, we will ask to provide saliva samples before and after CV4~     treatment. In particular, saliva will be collected four times per patient: at the initial~     time, after administration of a stressful event (hand immersion in ice water), immediately~     after application of the CV4 technique and thirty minutes after the application of the CV4~     technique. For each sample of saliva detected, we will proceed to measure the activity of~     alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous~     system.~   "
20724|NCT02785926|"~     During pregnancy, the foetus is therefore chronically exposed to a large number of~     substances. A number of studies have started to emphasize the effects of this antenatal~     exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.).~     However, in addition to these morphological effects, pesticides may also induce various~     effects on physiological functions, as some pesticides act as inhibitors of~     neurotransmitters involved in many nervous system regulation pathways in man. This is~     particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A~     previous study conducted by the coordinator of the project presented here demonstrated the~     presence of high levels of this type of pesticide in meconium (1st stool) in neonates born~     in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on~     neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory~     control, vital functions of the neonate particularly in preterm neonates, could therefore be~     affected.~      The PhysioMéco project is therefore designed to study the possible links between antenatal~     exposure to pesticides and modifications of respiratory control allowed by peripheral~     chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays~     in the meconium of neonates in combination with an exposure questionnaire to determine the~     sources of these pesticides. Sleep and respiratory control will be studied in these neonates~     nursed in incubators. Hypoxic test will be used in order to assess respiratory control~     involving the peripheral chemoreceptors.~   "
20725|NCT02785913|"~     This phase II trial studies how well taselisib (GDC-0032) works in treating patients with~     stage IV squamous cell lung cancer that has come back after previous treatment. This is a~     sub-study that includes all screened patients positive for the phosphoinositide 3-kinase~     (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease~     the activity of PI3K and may be able to shrink tumors.~   "
20726|NCT02785900|"~     The purpose of this study in AML patients is to test whether vadastuximab talirine~     (SGN-CD33A; 33A) combined with either azacitidine or decitabine extends overall survival~     longer than placebo combined with either azacitidine or decitabine.~   "
20727|NCT02785887|"~     This is a randomized parallel group trial designed to evaluate the impact of implementing~     geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA),~     on the ability to deliver adequate chemotherapy treatment, as measured by relative dose~     intensity (RDI).~   "
20728|NCT02785874|"~     Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk~     turning into liver cancer,however, the investigators also discovered that patients taking~     Statin live longer than patients who didn't take Statin in the incidence of liver cancer~     death cases.~   "
20729|NCT02785861|"~     After treatment, women want to regain a 'normal' lifestyle while some factors interfere as~     chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical~     deconditioning . The following protocol will focus at this problem.It will consist of a~     brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR~     pic during 20 minutes.~   "
20730|NCT02785848|"~     The investigators will explore barriers to improving self-efficacy, or the ability to feel~     in control of their disease, and medication adherence with text messaging through surveys~     and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry~     Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify~     preferences to improve and sustain adherence to daily medication through selection of~     investigator-proposed or patient-generated text messaging strategies. Finally, the~     investigators will fill in the literature gaps by describing barriers to self-efficacy and~     medication adherence among adults with SCD as well as adolescents with SCD who are~     transitioning to adult care.~   "
20731|NCT02785835|"~     Observational study. All HIV-infected patients who have been diagnosed of hepatocellular~     carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD)~     criteria, in the participant centers are included. Epidemiological, clinical and laboratory~     data are collected. The clinical and epidemiological characteristics of HCC cases will be~     analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed.~     Mortality and its predictors will be also assessed. In those cases infected by hepatitis C~     virus (HCV), the impact of HCV therapy on outcomes will be analysed.~   "
20732|NCT02785822|"~     Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is~     associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in~     isolation, its therapeutic management has special connotations sometimes favoring the low~     response although the standard is the tendency to hyperresponsiveness.~      Although there are studies comparing the combination of FSH and LH and FSH in controlled~     hyperstimulation of these patients, there are no previous prospective randomized studies~     comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG~     HP).~      Therefore the aim of this study is to prove that both drugs are comparable in the treatment~     of these patients. The test substances are marketed in Spain (Fostipur and Meriofert,~     respectively) with an indication for use in these patients. In this study both medicines~     will be administered in a randomized way under the usual conditions in which it is used in~     routine clinical practice to compare the quantity of mature oocytes respect to the total~     oocytes obtained, as a primary outcome measure.~   "
20733|NCT02785809|"~     The aim of this study is to investigate whether there is a correlation between~     anti-Müllerian hormone during long-term use of combined oral contraceptives and the recovery~     time before recovered menstrual cycle after discontinuation of oral contraceptives.~   "
20735|NCT02785783|"~     This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps~     detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the~     participants will receive EndoRings™ assisted colonoscopy, while the other half will receive~     standard colonoscopy.~   "
20736|NCT02785770|"~     This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy~     adult subjects. This is conducted as part of standard drug development.~   "
20744|NCT02785666|"~     The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in~     HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study~     pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact~     of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a~     nested project of the Swiss HIV Cohort Study entitled The Swiss HCVree Trial.~   "
20737|NCT02785757|"~     Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The~     guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show~     that oncologists are reluctant to use it because of concern over bleeding, absence of~     validated risk stratification tools and uncertainties concerning the optimal~     thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of~     each cancer patient and individually tailor their thromboprophylaxis.~      The study aims to identify thrombin generation test (TGT) as a reliable, standardized~     overall haemostasis assay that can be used to evaluate individual thrombosis risk~      The secondary objectives are:~        -  To define the limits of TGT parameters that indicate thrombosis risk in cancer patients~        -  To evaluate values of other clotting activation markers in patients with cancer~      Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any~     origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at~     baseline (Visit 1). Thrombin generating capacity will be measured within the first month~     following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2)~     and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will~     be followed up for a period of 1 year, or until the occurrence of a thromboembolic event.~     Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial -~     Visit 5) visits.~      Patients eventually undergoing second-line chemotherapy during the course of the follow-up~     will remain on study.~      The study will document all cases of symptomatic thromboembolic events together with the~     relevant diagnostic work-up.~   "
20738|NCT02785744|"~     Gaucher disease is a most common genetic metabolic disease characterized by low platelet~     number, liver and spleen enlargement and various forms of bone diseases including low bone~     mineral density leading to brittle bones. Various treatment options are now available for~     this disease.~      The purpose of this research study is to determine the prevalence of Gaucher disease in~     patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of~     the bone.~   "
20739|NCT02785731|"~     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system~     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood~     based on cellular size and deformability. In a small pilot study, scientists at the Medical~     University of Vienna demonstrated that measurement of a combination of mRNA markers~     extracted from CTCs captured using the Parsortix system could be used to identify women with~     ovarian cancer. This study is designed to provide specimens for optimization of an assay~     using clinical and biomarker information (i.e. demographics, imaging results and/or serum~     tumor markers) in combination with mRNA extracted from rare cells in the blood of women~     presenting with a pelvic mass for the detection of malignancy.~      Primary Objective: Optimization of an assay for the differentiation of women with benign~     pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs~     isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured,~     and the results will be compared to the actual clinical diagnosis made for each patient~     through other recognized methods (e.g. histopathology). The blood samples collected in the~     course of this study will be used to finalize the selection of mRNA and/or serum tumor~     markers to be evaluated in future prospective studies.~      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary~     design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers~     for estimation of the risk of ovarian cancer.~   "
20740|NCT02785718|"~     Cardiovascular diseases are important causes of morbidity and mortality in the~     industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable~     state, are a known risk factor for arterial and venous thrombosis. The contact activation~     system is part of the coagulation system and consists of four proteins: coagulation factor~     XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK). Clinical studies~     indicate an important role for the contact activation system on the risk of arterial~     thrombosis. Furthermore, there is substantial evidence from mouse studies that FXII and FXI~     participate in the formation and stability of thrombi. In vitro studies show that collagen,~     present in the vascular wall, is able to activate FXII and hereby stimulate thrombin~     formation and potentiate the formation of platelet-fibrin thrombi and FXIIa is able to~     change the structure of fibrin clots by binding to fibrin(ogen) and by generation of~     additional thrombin. However, the contact system also participates in the process of~     fibrinolysis, which degrades thrombi.~      The investigators would like to investigate the contribution of the contact activation~     system to the formation of thrombi. The formation of a thrombus within the vascular bed is~     the main cause for occlusion of an artery or vein, which can lead to an infarct such as a~     heart attack. Due to the other functions of the contact system it is important to fully~     understand how the contact system contributes to thrombus formation, before it can be used~     as a target in the treatment of arterial thrombosis. The aim of this study is to determine~     the contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet~     mediated formation and degradation of thrombi. This will be studied in flow models~     (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin~     generation assay.~   "
20741|NCT02785705|"~     Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch~     from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for~     preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed~     to assess immunogenicity and safety profile of six vaccination schedules with different~     sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.~   "
20742|NCT02785692|"~     Postoperative wound healing complications following preoperative radiotherapy represent a~     severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34%~     and more. The literature discusses intensely the advantages and disadvantages of this~     multimodal treatment concept and there are different opinions. The Canadian prospective~     randomized NCIC SR2 trial showed increased wound complication rates in the study arm~     receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment~     concept and the results shall now be analysed and published. The approach is to show that~     not only the complication rates are comparable to international bench marks, but also the~     (still intermediate time) local control rates.~   "
20743|NCT02785679|"~     Cow's milk protein (CMP) allergy is one of the most common food allergies and potentially a~     fatal one. Early feeding with CMP has been considered in the past as a risk factor for~     development of CMP allergy in high risk infants. Although other studies argue with this~     assumption and suggest early exposure to CMP might be protective against atopic dermatitis~     and CMP allergy. A cohort study that first introduction of CMP after 15-30 days of age,~     raised the risk for CMP allergy.The aim of this study is to investigate if early and~     continuous exposure to CMF will decrease CMP allergy rate.~   "
20745|NCT02785653|"~     This study evaluates the potentiation of muscle relaxation caused by rocuronium by~     inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous~     oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with~     oxygen and nitrous oxide.~   "
20747|NCT02785627|"~     The ANTELOPE trial is a longitudinal observational clinical study of changes in bone~     density, structure and strength over 12 months in men receiving treatment for prostate~     cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline~     and 12 months. Allowing for a 18 month recruitment period, 12 months follow-up and data~     analysis, the total study length will be 3 years. The groups comprise:~      Group A - Men with prostate cancer starting ADT~      Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to~     start (or have started within the past 3 months) ADT and who will undergo chemotherapy with~     docetaxel and prednisolone~      Group C - Age-matched men without prostate cancer~   "
20748|NCT02785614|"~     The main objective is to evaluate the pharmacokinetics comparative studies in a single dose,~     multiple dose~   "
20749|NCT02785601|"~     The main objective is to compare the pharmacokinetics in single dose, and effect of food on~     the trazodone hydrochloride pharmacokinetics prolonged-release tablets.~   "
20750|NCT02785588|"~     This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for~     imaging viable neonate and infant populations. This MR system has a smaller size and design~     features that may make it more feasible to locate the system in close proximity to care~     areas for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical~     neonatal intensive care units (NICUs) and other infant and neonatal care departments.~      This is a two-phase prospective clinical study evaluating the performance and safety of the~     investigational MRI device for neonates and infants, including:~        -  Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may~          include hardware and software modifications. These studies are guided by a series of MR~          scanning procedures defined in sequential Sponsor-provided MR Procedure Documents~        -  Phase 2 - Controlled image and data collection study based on Phase 1 results, in which~          optimized scan procedure(s) according to MR Procedure Document(s) will be provided at~          the start of Phase 2 scanning and a fixed hardware and integrated software~          configuration will be applied for all subjects.~      Investigator feedback on scanning conducted under each MR Procedure Document will be~     documented. Because the device is intended for use in viable neonate and infant populations,~     clinical data are required that cannot be conducted in any other populations or simulated on~     non-human models. Clinical images and associated data as well as assessments of image~     quality, workflow, and usability will be collected.~      Images, associated image data, and subject data collected in both phases of this study may~     be used for future engineering development and activities that support MR product~     development, including Sponsor-authorized scientific and marketing activities. Summary~     evaluation of safety and performance from Phase 1 and Phase 2 may be used in support of~     regulatory submission, including filings for European CE mark.~   "
20751|NCT02785575|"~     The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based~     and activated clotting time adjusted calculation for the dosing of Heparin and protamine and~     assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.~   "
20752|NCT02785562|"~     Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression~     : evaluation of clinical and pathological characteristics of PDL1 high expression patients~     compared to patients with a weak or no expression of PDL1.~   "
20753|NCT02785549|"~     Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion~     criteria and giving informed consent, will be included in the study protocol and will be~     randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus~     antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7~     days, 30 days and 3 months from the onset of the episode.~   "
20754|NCT02785536|"~     Tobacco use is a leading contributor to racial and socioeconomic health disparities in the~     US primarily due to an unequal burden of tobacco-related disease from a disproportionate~     share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other~     health risk behaviors, tobacco-related health disparities are increasing despite a large~     treatment network of free telephone and in-person counseling services, perhaps due to~     significant disparities in treatment outcomes. The goal of this project is to revise the~     standard treatment for tobacco dependence to address key factors associated with treatment~     outcome disparities and more fully meet the needs of lower SES and African American smokers~     thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting~     the alarming increase in tobacco-related health disparities, and reducing a leading cause of~     racial and socioeconomic health disparities in the US.~   "
20755|NCT02785523|"~     A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids~     to the immunological response in patients with G.I. Cancers. The trial is randomized,~     double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are~     randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma~     spore lipids or placebo capsules 600mg three times a day (TID) in addition to the~     chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality~     improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide~     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis~     factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2,~     Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female),~     testosterone (male), etc.~   "
20756|NCT02785510|"~     Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3%~     of population above 60 years. Recently, non-motor symptoms are getting more attention in PD~     management. The pattern of PD onset and clinical course differ from one population to~     another. Many studies have been conducted to determine the clinical profile of PD in~     populations worldwide. However, no similar studies have been conducted in Egypt. Therefore,~     the investigators will conduct a nation-wide, collaborative, cross sectional study to~     determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms~     among Egyptian population.~   "
20757|NCT02785497|"~     Skin lesions, such as chronic ulcers and burns, represent a serious public health problem~     due to high government costs, and scarce successful conservative treatments.There is a~     growing scientific literature on the use of electrotherapy in the process of wound healing,~     but in return there is a dearth of scientific studies on the use of various types of~     currents and the different parameters in the proposed treatments.~   "
20758|NCT02785484|"~     The purpose of this randomized controlled trial is to determine whether constituent~     disclosures on cigarette packs increase intentions to quit smoking. Previous studies have~     been informative, but they have evaluated candidate graphic warnings, not constituent~     disclosures. Furthermore, they typically expose participants to messages in controlled but~     artificial experimental settings for a short period of time, using much lower frequency and~     shorter duration of message exposure than found in the real world. This study addresses~     these issues by evaluating the impact of constituent disclosures by randomly assigning~     smokers to have their cigarette packs labeled with constituent disclosure messages or~     cigarette butt littering messages.~   "
20759|NCT02785471|"~     The purpose of this study is to test a comprehensive, male-oriented, online screening and~     referral (Screening for Mental Health; SMH) and male-oriented online information and~     referral intervention program (Man Therapy; MT) to improve mental health and wellbeing with~     a focus on prevention of suicide and help-seeking behaviors among middle-aged men. The~     online programs will be offered together to maximize the effect on reducing suicide behavior~     and increasing mental health help-seeking behaviors for men. If successful in decreasing~     suicide behavior and ideation and increasing suicide help-seeking behavior, this~     intervention could be scaled up to contribute to a reduction in suicide behaviors and deaths~     across the country.~   "
20760|NCT02785458|"~     This study evaluates the effectiveness of an electronic health record based educational~     intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk~     medications. Half of the participants will receive the intervention, while the other half~     will receive the usual amount of information (usual care).~   "
20761|NCT02785445|"~     The objectives of the Healthy.io Method Comparison and User Performance Study are:~        1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission®~          U500 Urine Analyzer.~        2. To evaluate the user performance of Dip.io Device under actual use conditions (home~          environment) based on a user questionnaire and rating scale.~   "
20762|NCT02785432|"~     1. Examine the use of low level therapeutic laser (LLLT) combined with physical therapy~          for improvements in pain, range of motion, and function in individuals with chronic~          pain from musculoskeletal conditions.~        2. Compare changes in pain, mobility, and ability to return to home/work/recreational~          activities between treatments with standard physical therapy plus LLLT or the standard~          physical therapy program alone.~   "
20763|NCT02785419|"~     After stroke, individuals often have persistent difficulty using the arm and hand in~     everyday functional tasks that reduces quality of life. Currently available rehabilitation~     techniques are not adequate and new protocols are needed that are based on an understanding~     of how brain regions work together to produce skilled movement. This research project aims~     to improve our understanding of how the brain controls movement after stroke and determine~     whether a period of motor practice that targets specific brain regions through the addition~     of action selection demands leads to improved arm function. We hypothesize that arm motor~     function and the ability to efficiently activate the action selection motor circuit during~     movement will improve after training.~   "
20764|NCT02785406|"~     The purpose of this study is to determine the effectiveness of a medication called~     suvorexant in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine~     use.~   "
20765|NCT02785393|"~     The purpose of the study is to asses the potential interactions between methamphetamine and~     doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study~     will evaluate the effects of doxazosin on the cardiovascular and subjective effects of~     methamphetamine in a human laboratory study.~      The primary objective is to determine the safety of treatment with doxazosin in~     methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of~     administration of ascending doses of methamphetamine and a placebo dose during treatment~     with doxazosin.~      The secondary objective is to determine effects of treatment with doxazosin, as compared to~     placebo, on subjective effects produced by administration of methamphetamine or placebo~   "
20766|NCT02785380|"~     Management of recurrent HCC is urgent and several treatments have been developed .Repeat~     hepatectomy is considered to be the first choice for recurrent HCC.~      Unfortunately, repeated open hepatectomy can be performed only in a small proportion of~     patients due to inadequate liver function reserve, widespread recurrence or high~     invasiveness. Given that recurrent tumors are usually detected at small size during~     follow-up after initial surgery, radiofreqency ablation (RFA), which is less invasive, may~     be locally curative and causes minimal damage to liver function reserve,has been widely~     used. However, the re-recurrence rate after RFA is more than 50%,and the recurrence-free~     survival is less than 20%. Recently, satisfactory short- and long-term oncological outcomes~     have been reported for laparoscopic surgery (LS) for the treatment for primary HCC with~     cirrhosis. Some single center pilot studies reported that LS may, compared with open~     surgery, improve the prognosis of HCC with less blood loss and shorter hospital stay. LS was~     initially considered not suitable for recurrent HCC due to postoperative adhesions that~     might make laparoscopic surgical procedure more difficult and less safe. With improvement in~     technique and experience, recent studies showed that LS for recurrent HCC in cirrhotic~     patients is a safe and feasible procedure with good short-term outcomes. However, thus far,~     no study has been performed to evaluate the long-term oncological outcomes of LS for~     recurrent HCC, and compare those results to that for RFA. To clarify these issues, a~     multicenter retrospective comparative study by using propensity score matching method that~     included a large consecutive series of patients with recurrent HCC within Milan criteria,~     who underwent LS or RFA, was performed.~   "
20767|NCT02785367|"~     The pH levels of a neonatal at his birth are an important factor in establishing the~     connection between events that occurred during the actual time of birth, to the risk of a~     significant morbidity development in the future. Gas values in cord blood are measurable and~     represent the condition of the fetus close to the time of birth. Their level is one of the~     essential criteria which are used to define acute hypoxic event during birth. As the oxygen~     supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing.~     Therefore, the tissues begin to accumulate large amounts of acid and thereby developing~     fetal blood acidosis. Many works connected the presence of cord blood acidosis to~     development of neonatal cerebral palsy. According to the American Association of Obstetrics~     and Gynecology, cord blood gas sample is necessary when a prenatal event may be related~     (rightly or not) with negative neonatal outcome. This approach might be necessary when the~     case is legally controversial and there is a need to prove that umbilical cord gas values~     were normal at the prenatal period.~   "
20768|NCT02785354|"~     The study is an analysis using the French national health insurance database, six months~     after the beginning of NOAC launch in the NVAF indication.~      The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding,~     arterial thrombotic events, myocardial infarction (MI), death) between patients starting a~     NOAC and patients starting a VKA for NVAF in 2013~   "
20769|NCT02785341|"~     Although treatments significantly increase the life expectancy of cancer patients, their~     quality of life is more or less reduced. The development of supportive care, such as~     physical activity, is one of the tools that should be promoted to maintain quality of life~     and reduce treatment side effects, including fatigue.~      This study was developed to understand the different biopsychosocial effects of a physical~     activity program carried out with patients suffering from various types of cancers, and to~     facilitate and improve the implementation of this type of activity in health care~     facilities.~      Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and~     adapted physical activity program.~      Participants were assigned to one of two groups: Group A which first follows a 12-week~     physical activity program, then undergoes usual care for 12 additional weeks, or Group B,~     which continues usual care for 12 weeks (control group) and then starts the physical~     activity program for 12 additional weeks. Quality of life (with questionnaires for 2 groups)~     , well-being, fatigue, physical capacity, leptin concentration, goal setting and level of~     physical activity are evaluated during this protocol.~      By understanding the multidimensional effects of a physical activity program for various~     cancer types, depending on the time of proposing the program, by evaluating the correlations~     among all these variables, and by evaluating long-term effects, the IPCAPA study contributes~     to identifying the physical activity program which will be effective, viable and feasible~     for all patients undergoing chemotherapy, whatever the type of cancer.~   "
20770|NCT02785328|"~     Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good~     daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning~     is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated~     in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain~     plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been~     studied during childhood and in children affected by sleep disorders. Yet, sleep disorders~     concern almost 30% of children and are frequently related to a worsening in academic~     performances. Classical neuropsychological evaluations of these children, based on daytime~     learning, often fail to determine cognitive profiles explaining their academic difficulties.~     The investigators hypothesize that a lack of sleep-dependent consolidation could take an~     active part in these children's cognitive and academic difficulties. This proposal aims at~     characterizing interactions between sleep, learning and memory processes that have not been~     studied in children of elementary school age (6-12 years). The investigators will evaluate~     sleep-dependent memory consolidation processes in children with sleep disorders before and~     after treatment and healthy controls. Neuropsychological testing and academic performances~     will be also evaluated.. The comparison of performances obtained before and after medical~     treatment, will allow to understand whether normalisation of sleep quality permits the~     restoration of sleep-dependent memory consolidation.~   "
20771|NCT02785315|"~     People with mild cognitive impairment (MCI) are at a greater risk of developing dementia.~     Therefore, it is important to develop effective non-pharmacological interventions to~     facilitate their cognitive and activities of daily living (ADL) function, which will also~     prevent or delay their progression to dementia and reduce associated healthcare and social~     costs. There are currently a variety of cognitive interventions, mainly categorized as~     remediation and rehabilitation approach. Research to compare their contents and~     effectiveness is strongly needed. The information can be used to individualize cognitive~     intervention based on specific cognitive profile of the patient.~      This study aims to determine the immediate and long-term efficacy of the remediation~     approach and rehabilitation approach in enhancing the cognitive and ADL function. The~     research questions include 1) whether the rehabilitation approach compared with the~     remediation approach has better effects on improving ADL function; (2) whether the~     remediation approach may only enhance the performance on the cognitive tests rather than on~     the ADL function. This study will also explore whether the attitudes of caregivers on~     providing ADL assistance affect effects of cognitive intervention.~   "
20772|NCT02785302|"~     This is a multi-site, longitudinal study and it describes the transition process of~     behaviorally-infected HIV-positive youth as they move from pediatric- and~     adolescent-specific care to adult care. To achieve this goal, the transition process is~     characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit~     (AMTU) clinic staff, and receiving adult clinic staff.~   "
20773|NCT02785289|"~     The purpose of this study is to compare the performance of cotton and flocked swabs for~     vaginal self-sampling.~   "
20774|NCT02785276|"~     Aim~      The general aim of this study is to improve post-operative pain and reduce morphine~     consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to~     conduct a randomized, double blinded, controlled trial to investigate the effect of~     intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and.~      Methods:~      Patients will be randomised by computer generated random numbers (random permutation) and~     opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain~     pump system will be placed in the peritoneal cavity between the onlay mesh and parietal~     peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h.~     In the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The~     infusions will run for 68 hours total. All members involved in patient care (with the~     exception of one independant research fellow) will be blinded to the above. After 68 hours~     the pump will be stopped and the catheter will be removed. Assessment of post-operative pain~     will be performed by visual analogue scale, and total opiate consumption will be collected~     and converted into morphine equivalents.~      Health significance:~      Local anaesthesia has become an important addition to multimodal regimens of analgesia~     following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration~     has improved post-operative pain when compared with standard opioid regimens for pain~     relief. Only one previous study looked at bupivacaine infusions into the hernia sac for~     three days following LVHR. This study found no improvement in post-operative pain or~     morphine consumption. We aim to demonstrate improved pain and reduced morphine consumption~     using an alternative catheter insertion technique and ropivacaine as the desired LA agent.~   "
20775|NCT02785263|"~     The purpose of this study is to maximize patient involvement in the treatment of anal~     cancer. Specifically, the investigators will investigate whether patients wish to take part~     in the decision making on radiation dose and whether they want a high or low radiation dose.~   "
20776|NCT02785250|"~     Immunotherapeutic survivin vaccine DPX-Survivac, low dose oral cyclophosphamide, and IDO1~     inhibitor epacadostat will be tested together for the first time in patients with recurrent~     ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential~     immune-modulating activity of the combination of these agents.~   "
20777|NCT02785237|"~     The objective of the study is to evaluate the process of early re-endothelialization of the~     Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent~   "
20778|NCT02785224|"~     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors~     plan to conduct a pertinent mediation analysis using prospectively collected data from 2~     prior randomized clinical trials of in-hospital cardiac arrest. These trials reported~     positive results on the vasopressin-steroids-epinephrine (VSE) combination. The current~     analysis is aimed at identifying mediators of the benefit associated with VSE, potentially~     attributable to its stress-dose steroid subcomponent. Tested mediators will include arterial~     pressure in the early postresuscitation period (primary), and arterial blood lactate in the~     early postresuscitation period and renal failure free days (secondary).~   "
20779|NCT02785211|"~     Background: It is essential to understand how to prevent and treat the epidemic of~     depression. Several studies have reported the prevalence of depressive symptoms in the urban~     population in China, but there is a lack of information regarding intervention for~     depression in rural left behind old elderly people.~      Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment~     (MBAT) Intervention on reducing depressive symptoms in rural left behind elderly people.~      Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score~     between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and~     control group(n=40). The intervention group will be received both MBAT and~     treatment-as-usual for 8 weeks while the control group received treatment-as-usual. Both~     groups will be assessed with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness~     Questionnaire (OHQ) at baseline, immediately post-intervention, and at 3 months~     post-intervention.~      Significance: This is the first time BA psychotherapy will be used in China.The current~     study will develop an intention model based on the traditional BA and CBT. The recurrence~     and seriousness of depression symptoms may be reduced by the intervention program. We hope~     that MBAT in clients will provide a direction for the management of mental health in rural~     left-behind elders..~   "
20780|NCT02785198|"~     Overall project design: This PhD project involves a randomized study on diabetic individuals~     with healing resistant wounds, comparing the effect of passive movement of the lower limb~     with standard treatment of diabetic wounds.~      How to effectively improve the condition of peripheral arterial disease is limited. The~     primary purpose of this study is to uncover whether passive movement of the lower limb will~     influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle~     oxygen demand is likely to increase both blood flow rate and the number of capillaries,~     which would induce the healing of wounds, that were not previously possible.~      The secondary purpose is to increase understanding of the pathophysiological processes in~     wound healing through the study of biochemical markers of vascularization, inflammation and~     stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of~     the number and quality of endothelial cells and Capillary density and to develop new~     quantifiable methods to evaluate wound healing in.~      The project is a randomized trial, consisting of simple passive training to improve blood~     vessel function, increase the growth of the smallest blood vessels, thereby preventing~     ulceration and ultimately amputation.~   "
20781|NCT02785185|"~     A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.~   "
20782|NCT02785172|"~     Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque~     Psoriasis~   "
20783|NCT02785159|"~     Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis~   "
20784|NCT02785146|"~     A randomized, paralleled control clinical study investigating Huaier Granule for prevention~     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the~     efficacy and safety.~   "
20785|NCT02785133|"~     This study uses a prospective non-randomized, non-controlled design. Five-hundred (500)~     subjects having previously received a peripheral intravenous therapy will be enrolled into a~     single treatment group. The purpose of the study is to evaluate the safety, feasibility, and~     improved energy levels following treatment with a low-light source integrated into an~     existing peripheral intravascular catheter. The absence of a control group is based on the~     following reason:This is a pilot investigation to establish a baseline understanding of the~     safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated~     into an existing 20-gauge 1.0 inch intravenous catheter to improve self-reported overall~     subject energy levels.~   "
20786|NCT02785120|"~     This is a phase 2, multicenter, randomized, double-blind (within dose), placebo controlled,~     parallel-group, dose-range finding study to evaluate the efficacy and safety of TF0023 spray~     versus placebo in functional improvement of patients with ischemic strokes under standard of~     care.~      Objective of the study:~      To evaluate the efficacy of TF0023 spray compared with placebo for functional improvement of~     patients with ischemic strokes measured by the change from baseline in the mRS score for all~     randomized patients at Week 16 for Part A and Part B, separately.~   "
20787|NCT02785107|"~     The promotion of physical activity (PA) is paramount to public health, yet interventions in~     the social cognitive tradition have yielded negligible improvements. Two reasons for these~     results may be the over reliance on intention as the proximal determinant of behaviour and a~     lack of consideration of implicit/automatic determinants of PA. The purpose of this study~     was to apply Multi-Process Action Control (M-PAC), a framework centered on PA~     intention-translation and the gradual building of habit to examine PA change using a two-arm~     parallel design, randomized controlled trial.~   "
20788|NCT02785094|"~     This study focus on measuring effect of Egyptian Primigravidas' education level and~     accessibility to social media on rate of maternal request option offered for non-indicated~     primary caesarean section.~   "
20789|NCT02785081|"~     The purpose of this study is to evaluate the thoracic skin to epidural space depth in~     children and define the ratio between the straight and inclined thoracic skin to epidural~     depth.~   "
20790|NCT02785068|"~     A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in~     RAS/RAF wild-type Metastatic Colorectal Cancer.~   "
20791|NCT02785055|"~     This blinded, randomized study compares standard palpation to ultrasound-assisted landmark~     identification of the thoracic spine for thoracic epidural catheterization.~   "
21432|NCT02776644|"~     The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since~     targeted therapy being widely applied. This study will retrospectively analyse the clinical~     outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance~     Research Database.~   "
20792|NCT02785042|"~     This prospective, single-arm clinical multicenter study intends to measure normal structural~     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the~     macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic~     descent volunteers. The main goal of the study is to provide the range of these structural~     parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10~     study sites will recruit subjects. Overall an approximately equal age distribution from 18~     to 90 years and an approximately equal number of females and males will be enrolled~     (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT~     imaging, biometric and ophthalmoscopic examination, disc photography and visual field~     testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be~     performed at a second visit within 30 days of the initial visit. All examinations performed~     on the subjects are non-significant risk procedures.~   "
20793|NCT02785029|"~     This prospective, single-arm clinical multicenter study intends to measure normal structural~     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the~     macula using the Heidelberg Spectralis OCT device. This study is conducted in~     African-American descent volunteers. The main goal of the study is to provide the range of~     these structural parameters in normal eyes. The study will include at least 240 normal~     volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age~     distribution from 18 to 90 years and an approximately equal number of females and males will~     be enrolled (approximately 40-60% females in each age group). All subjects will undergo~     Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and~     visual field testing in one single visit, if possible. Repeated perimetry or Spectralis~     scans may be performed at a second visit within 30 days of the initial visit. All~     examinations performed on the subjects are non-significant risk procedures.~   "
20794|NCT02785016|"~     This is a prospective, non-randomized, observational, single center study in which subjects~     that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling~     operative procedure.~   "
20795|NCT02785003|"~     This study will evaluate the effectiveness of ketamine infusions in the management of acute~     pain following open or laparoscopic colorectal surgery cases. Half of patients will receive~     the institutional standard of care and a placebo infusion (no active medication). The other~     half of patients will receive the institutional standard of care and a ketamine infusion.~     All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.~   "
20796|NCT02784990|"~     Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery~     can be accompanied by complications among which the main one is pancreatic fistula, which~     leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity,~     a fistula can be managed medically, with the implantation of a la pose d'un percutaneous~     drain, endoscopic treatment, or revisit surgery. It has been shown that early management of~     the fistula prevents it from evolving towards major complications such as haemorrhage or~     serious intra-abdominal infections.~      To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic~     enzyme, amylase, in the drains. However in certain clinical situations, patients present~     post-operative fistulas with no elevation of amylase. And, on the contrary, increased~     amylase with no clinical consequences.~      It is therefore necessary to identify another early early marker of pancreatic fistula that~     corresponds better to clinical signs.~      In a preliminary study conducted in 65 patients, the investigators recently found that~     another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula,~     but this requires confirmation in a greater number of patients.~      The objective is to evaluate the diagnostic performance of lipase in the drains for the~     early detection of pancreatic fistula with clinical repercussions in the 30 days following~     the surgery.~      The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of~     blood and a tube of drain liquid.~   "
20797|NCT02784977|"~     Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a~     cross-sectional nationwide database to define clinical and polysomnographic characteristics~     of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients~     with metabolic and cardiovascular diseases as well as risk for traffic accidents will be~     explored as secondary aims. Impact of treatment of sleep apnea on metabolic and~     cardiovascular complications as well as compliance with positive airway pressure treatment~     will be further explored longitudinally.~   "
20798|NCT02784964|"~     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee~          osteoarthritis~        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee~          osteoarthritis~   "
20799|NCT02784951|"~     The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of~     exsanguinating patients by physician-staffed emergency medical services in Norway, with~     focus on prehospital transfusion complications and safety.~   "
20800|NCT02784938|"~     The purpose of this project is to evaluate a promising peer-run psycho-educational group~     intervention titled Vocational Empowerment Photovoice (VEP) that aims to empower~     individuals with the most disabling psychiatric disabilities to engage in vocational~     services and pursue employment through the enhancement of their vocational hope, sense of~     vocational identity, work motivation, work-related self-efficacy, and capacity to deal with~     psychiatric stigma and discrimination.~   "
20801|NCT02784925|"~     Ultrasound (US) B mode image is an alternative method to measure tissue structure and has~     proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing~     the transducer onto the skin with too much force will significantly reduce the subcutaneous~     adipose tissue thickness. In this study, a force controlled system combined with US~     transducer was used for 3D subcutaneous fat imaging and reconstruction.~   "
20945|NCT02783027|"~     The overarching goal of this proposal is to address the MedEvac foundation priority of~     educational techniques and technologies and improve Helicopter Emergency Medical Services~     (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS~     clinicians can be improved with real-time assessment and intervention.~      Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS~     clinician fatigue reported in real-time during and at the end of shift work.~      Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality~     and sleep health indicators including hours of sleep and recovery between shift work.~   "
20802|NCT02784912|"~     Prevalence of HF reaches 1-2% of developed populations, and consequently a significant~     problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained~     ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation.~      The aim of the study is to create a model of risk stratification to identify patients with~     increased risk of occurrence of composite (cardiovascular death or rehospitalization,~     arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or~     rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or~     sustained VT. Model will be based on additional measurements of N-terminal pro brain~     natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high~     sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency~     to clinical-, electrocardiographic- and echocardiographic assessment.~   "
20803|NCT02784899|"~     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary~     shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far,~     hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost~     is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary~     artery resistance by selectively dilating pulmonary artery. In this prospective, randomized,~     double blind study, investigators are planning to investigate the effects of iloprost on~     respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc).~   "
20804|NCT02784886|"~     The purpose of this study is to determine whether, in a high risk population (placenta~     praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)),~     the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly~     increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine~     if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful~     biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography~     and RMI).~   "
20805|NCT02784873|"~     The purpose of the trial is to compare the effects of high intensity interval training~     (HIIT) with usual care - moderate intensity steady state training (MISS) - in UK cardiac~     rehabilitation (CR) programmes.~   "
20806|NCT02784860|"~     This study assesses the benefits of continuous intravenous lidocaine administration during~     sedation for colonoscopy.~      Sedation will consist of propofol infusion titrated to provide adequate working conditions~     to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine~     infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same~     volume of placebo (normal saline)~   "
20807|NCT02784847|"~     A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial~     metabolism, for the preventative treatment of migraine.~   "
20808|NCT02784834|"~     The purpose of the study is to investigate the safety of the investigational drug called~     dimethylfumarate (DMF). DMF is a type of drug called an immunomodulatory drug. This drug is~     approved by the United States (U.S.) Food and Drug Administration (FDA) as a treatment for~     patient with multiple sclerosis.~      Although there is evidence from tests on laboratory animals that DMF can decrease the number~     of CLL cells, we do not know if this will work in humans with CLL. This drug will be given~     to humans with CLL for the first time in this study. Therefore, the goal of this study is to~     see if DMF is safe and tolerable in study participants. Participants will be evaluated to~     find out what effects (good and bad) DMF has on the body and see how long the drug stays in~     the body.~   "
20809|NCT02784821|"~     Prolonged antibiotic use in preterm neonates has significant consequences on the developing~     intestinal microbiome, metabolome and host response, predisposing the neonate to various~     major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis,~     bronchopulmonary dysplasia (BPD), and mortality.~      The hypothesis is that early and prolonged antibiotic use in preterm neonates has~     significant consequences on the developing intestinal microbiome, metabolome and host~     response, predisposing the neonate to various major morbidities. It is possible that the~     effect of this widespread antibiotic use outweighs the potential benefits. This study will~     randomize preterm infants born at less than 33 weeks gestation to either pre-emptive~     antibiotics or no-pre-emptive antibiotics.~      The purpose of this research is to evaluate the risks and benefits of current practice to~     determine optimal levels of antibiotic use that protects the babies from infection with~     minimal effect on the microbiome and subsequent adverse outcomes related to overuse of~     antibiotics.~   "
20810|NCT02784808|"~     This study is designed to analyze the frequency and incidence rate of pulmonary~     complications in JIA participants who received biological DMARDs and non-biologic DMARDs.~     The participants having evidence of of a prescription or administration of one of the~     biologic or non-biologic DMARDs will be included in five different treatment groups. Data~     from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases~     will be used to estimate the incidence rate of pulmonary complications.~   "
20811|NCT02784795|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3039478 in combination with other anticancer agents in participants with advanced or~     metastatic solid tumors.~   "
20812|NCT02784782|"~     Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they~     have a large impact on patient's wellbeing and are a large economic burden to society.~     Thoracolumbar burst fractures might not need the standard care of brace immobilization for~     adequate treatment and a functional treatment might lead to same or better functional~     outcomes. Besides that, with functional outcome length of hospital stay might decrease and~     it might also be cost effective compared to bracing.~      Objective: The investigators aim to study the use of braces for thoracolumbar~     burstfractures, not only by measuring the functional scores and the effect of the bracing or~     functional treatment on the increase in kyphosis angle, but also on (health related) quality~     of life and health economics. The investigators hypothesize that no treatment is superior~     over one other.~      Study design: This project is a randomised controlled trial comparing brace and no brace~     treatment on function, kyphosis angle, pain, quality of life, and costs.~      Study population: Patients between 18 and 65, with a single level thoracolumbar burst~     fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees~     and patient has to be neurologically intact. Patients are excluded when they are overweight~     (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge~     of the Dutch language. Patients included in the brace group will automatically take part in~     a brace compliance study.~      Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the~     other group receives no TLSO Main study parameters/endpoints: The primary outcome of this~     study is the functional score at six months after trauma. Secondary outcomes are pain,~     kyphosis angle, health related quality of life, healthcare costs and brace compliance.~      Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no~     potential risks are known comparing a brace and a functional treatment. Investigators aim~     that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and~     less costs. Patients will be seen at first presentation and during two year follow up at the~     outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray~     as part of standard care is made. At or just before each scheduled appointment they will~     fill in questionnaires taking from 15-45 minutes.~   "
20813|NCT02784769|"~     During their biological life, proteins undergo molecular aging due to many non-enzymatic~     post-translational modifications that alter their structural and functional properties.~     These reactions concern all proteins but especially tissue proteins (whose half-life in the~     organism can be several decades) and lead to the formation of complex products called PTMDPs~     (post-translational modification derived products). Molecular aging is responsible for the~     alteration of protein properties which may cause changes in mechanical properties of tissues~     during aging and pathologies. However, the involvement of these processes in vivo remains~     unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine~     whether the molecular aging of matrix proteins within the vessel wall may participate in the~     development of aortic aneurysm.~   "
20814|NCT02784756|"~     The study will prospectively determine the clinical utility of CMV cell-mediated immunity~     using the Quantiferon test. The investigators will use the assay results to tailor the~     duration of CMV prophylaxis in solid organ transplant patients.~   "
20815|NCT02784743|"~     Lymphatic filariasis is a public health problem in Mali. The existing data are not up to~     date and most of them are more than 15 years old. To address this issue in April 2000, the~     investigators started studies to update the epidemiology of lymphatic filariasis. There is~     no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive~     chemotherapy treatment or vector control.~      To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin~     combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly~     endemic villages of Mali.~   "
20816|NCT02784730|"~     Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly~     medical devices used for the administration of chemotherapy.~      Placement of these devices via central venous access is sometimes responsible for~     complications.~      The incidence of these complications is correlated with the device holding time.~      A strategy of iterative PICC placement could significantly reduce these complications.~   "
20817|NCT02784717|"~     This non-interventional field study will investigate rivaroxaban under clinical practice~     conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients~     with non-valvular atrial fibrillation in China.~   "
20818|NCT02784704|"~     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with~     meropenem in the treatment of complicated intra-abdominal infections (cIAIs).~   "
20819|NCT02784691|"~     The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on~     osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis~     allowing an improvement of transdermal diffusion of active (Diclofenac).~   "
20820|NCT02784678|"~     The purpose of this study is to confirm that minimally invasive closed reduction and~     internal fixation with fully threaded headless cannulated compression screws for distal~     radius fracture repair has advantages over conventional open reduction internal fixation~     with titanium plates, providing superior fragment stability and allowing for early~     rehabilitation exercise of the wrist joint, which improves recovery of function. Also to~     show that minimally invasive closed reduction and internal fixation with fully threaded~     headless cannulated compression screws is the more suitable surgical method for repair of~     distal radius fracture.~   "
20821|NCT02784665|"~     Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger~     patients. It is characterized by serous detachment of the neurosensory retina with or~     without serous detachment of the retinal pigment epithelium (RPE), which can cause vision~     drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage~     can be treated with traditional laser photocoagulation, but it has the side effects of~     causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another~     effective treatment but it's more than most families can afford to pay because of the high~     cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal~     pigmental epithelium (RPE) atrophy and RPE rip.~      To date there is no international consensus on the optimal treatment of CSC Many~     retrospective studies suggest that micropulse laser (MPL) therapy may also be effective~     without obvious complications in this disease.~      The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute~     central serous chorioretinopathy compared with the traditional laser coagulation.~   "
20822|NCT02784652|"~     Bone metastasis causes bone destruction and skeletal related events (SRE) including~     compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative~     treatments for pain control and local control have become important and multidisciplinary~     multimodality approach is needed for treatment of bone metastasis.~      The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that~     bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In~     previous retrospective reports, the combination of local RT and systemic bisphosphonate was~     more effective than RT alone.~      Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in~     combination with zoledronic acid on pain relief and the safety of RT in bone metastasis~     patients with gastrointestinal tumors.~   "
20823|NCT02784639|"~     The goal of this multicenter prospective study is to validate, and ultimately translate in~     routine clinical practice, the use of plasma analysis of ccfDNA for the determination of~     KRAS mutation status in mCRC patients.~   "
20824|NCT02784626|"~     In this study, based on the hypothesis that dexmedetomidine administered intraoperatively~     for sedation can reduce postoperative pain than that of propofol, the investigators examined~     the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the~     total knee arthroplasty.~   "
20839|NCT02784418|"~     Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic~     patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary~     intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.~      Treatment:CTO PCI, as per standard clinical practice.~      Control: Patients randomized to sham-procedure will undergo only bilateral arterial access,~     without angiography or PCI being performed.~      Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire~     duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement~     in individual components of patients' health status (3) Greater improvement in exercise~     capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural~     and long-term~   "
20825|NCT02784613|"~     This is an unblinded study to be conducted at a single research center, San Diego Sexual~     Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene~     daily for twenty weeks. After the informed consent is signed, a baseline physical~     examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina,~     will be performed. Physical examination and vulvoscopy with detailed photography of the~     vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20~     weeks. Therefore, physical examination and vulvoscopy with detailed photography of the~     vulva, vestibule and vagina will be performed prospectively at baseline (vulvoscopy session~     1), 4 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy~     session 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following~     daily administration of 60 mg ospemifene.~   "
20826|NCT02784600|"~     The purpose of this clinical registry is to prospectively collect and compare preoperative~     and postoperative patient-reported data using validated shoulder-specific and health-related~     quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive~     implant to treat rotator cuff tears.~   "
20827|NCT02784587|"~     Based upon Northern New England Cardiovascular Study Group data, the rate of post operative~     atrial fibrillation (POAF) requiring treatment following coronary artery bypass grafting~     (CABG) at Maine Medical Center (MMC) is currently 30%. Nationally, POAF occurs in up to 40%~     of patients post CABG, 50% of patients after valve surgery, 64% of patients post mitral~     valve and CABG and 49% after aortic valve replacement. Atrial fibrillation worsens a~     patient's hemodynamic status and increases the risk of congestive heart failure (CHF),~     embolic events and longer ICU stays leading to increased patient morbidity and strain on~     financial resources. In the U.S., POAF carries a higher risk of stroke (37% OR 2.0~     in-hospital mortality (OR = 1.7), worsened survival (74% versus 87%), and an additional 4.9~     days and $10,000-$11,500 in hospital stay costs.~      Atrial fibrillation requires both an initiation trigger and favorable environment for~     maintenance and the sympathetic and parasympathetic nervous systems play important roles in~     this regard. Unfortunately, the precise mechanisms of POAF are still being investigated.~     This postoperative complication has persisted in spite of efforts to mitigate it~     pharmacologically with beta blockers and amiodarone, an experience shared by most other~     cardiac surgery centers.~      The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion~     and first thoracic sympathetic ganglion. By modulating the sympathetic component of the~     autonomic nervous system, stellate ganglion stimulation has been shown to facilitate~     induction of atrial fibrillation while ablation may reduce or prevent episodes. Human~     studies have further supported this model.~      Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery~     suggest that this technique may reduce or prevent episodes of POAF requiring treatment. The~     investigator's ultimate goal is to determine whether SGB reduces the incidence of POAF in~     specific cardiac surgery populations at MMC. First, however, the investigator proposes to~     test the hypothesis that SGB, performed perioperatively by cardiac anesthesiologists in a~     population of patients undergoing cardiac surgery, is both safe and clinically feasible.~   "
20828|NCT02784574|"~     This study aims to investigate current aftercare activities in Denmark after intensive care~     unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare,~     and these interventions are heterogenic and differ between hospitals and regions.~      This study is an electronic questionnaire survey that aim to describe and map Danish~     aftercare activities, and future development plans in this field.~   "
20829|NCT02784561|"~     The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG~     (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in~     Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem~     cell transplantation.~   "
20830|NCT02784548|"~     This study will develop a virtual reality-based treatment for phantom limb pain among~     Veterans and test it against the most established behavioral therapy for phantom limb pain,~     mirror therapy.~   "
20831|NCT02784535|"~     Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic~     hypotension are scarce and not effective. If left untreated, these patients have the highest~     risk of syncope, falls and fall-related injuries. The proposed study will determine the~     clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms~     associated with neurogenic orthostatic hypotension in patients with autonomic failure.~   "
20832|NCT02784522|"~     This study protocol represents an attempt to objectively choose appropriate methods for~     internal fixation of proximal humerus fractures in older patients by comparing locking~     compression plate with conventional steel plate fixation to improve shoulder function.~   "
20833|NCT02784509|"~     The purpose of this study is to determine the effect of severe obesity on physical activity,~     sedentary behavior and cardiometabolic risk factors during childhood and adolescence and~     whether these associations are modified by race. Additionally, the study will investigate~     the contributions of (total, regional, and depot-specific) fat accumulation on changes in~     physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and~     adolescence.~   "
20834|NCT02784496|"~     The goal of this clinical research study is to collect data about the long term safety and~     tolerability of ruxolitinib when given to patients with MF.~   "
20835|NCT02784483|"~     The purpose of this pilot study is to gain initial insights into the biologic and clinical~     effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may~     provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially~     be relevant to its future development in Multiple Myeloma (MM) and other indications.~   "
20836|NCT02784470|"~     Selection of the optimal treatment for gastric outlet obstruction in patients with radically~     unresectable gastric cancer remains controversial because previous studies comparing the two~     procedures had a small sample size as well as they included various etiologies such as~     gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the~     patient population. Therefore, to establish the standard of care for patients with radically~     unresectable gastric cancer with gastric outlet obstruction, a larger prospective,~     randomized, controlled clinical trial using a single type of stent is warranted.~   "
20837|NCT02784457|"~     Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe~     ovarian hyperstimulation syndrome and had cancelled embryo transfer~   "
20838|NCT02784444|"~     This is a randomized, double-blinded study of three doses of MSDC-0602K (62.5, 125 and 250~     mg) or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and~     no cirrhosis. Subjects will be stratified by presence of T2DM (Yes/No), use of Vitamin E ≥~     400 IU (Yes/No) and fibrosis score (1 or ≥ 2) to ensure equal representation across all~     groups. The primary efficacy endpoint, hepatic histological improvement in NAS defined as a~     decrease of at least 2 points with no concurrent worsening of fibrosis stage,will be~     assessed at 12 months. Visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12~     months, with one 2- week follow-up visit.~   "
20840|NCT02784405|"~     Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the~     treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel~     calibers and to auto-expand after their release to self-appose to vessel walls is~     particularly useful in the presence of ectasic coronary arteries or significant vessel~     tapering. The investigators planned this study to assess the feasibility, the effectiveness~     and the safety of the implantation of self-apposing, drug-eluting Stentys stents for~     percutaneous coronary intervention.~      Consecutive patients undergoing percutaneous coronary intervention with implantation of a~     self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria~     were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were~     defined.~      Primary end-point of the study is the occurrence of MACE (death, myocardial infarction,~     stent thrombosis, unplanned hospitalization for unstable angina, target lesion~     revascularization). Secondary end-points include individual components of MACE, procedural~     complications (periprocedural MI, bleedings, access site complication, failure to cross~     stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent,~     contrast-induced nephropathy), bleedings at follow up.~   "
20841|NCT02784392|"~     The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral~     feeding intolerance.~   "
20842|NCT02784379|"~     Mastalgia is a common problem for women. The aim of this study is to investigate the role of~     neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.~   "
20843|NCT02784366|"~     The purpose of this study is to establish a prospective observational cohort of cancer~     immunotherapy patients with GI side effects in order to identify biomarkers that predict GI~     complications due to treatment.~   "
20844|NCT02784353|"~     Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP~     Malignancy.~   "
20845|NCT02784340|"~     A Prospective, randomized study conducted on 120 pregnant women attending the labour wards~     in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All~     participants were scheduled for elective cesarean section under spinal anaesthesia and were~     randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV~     drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the~     caesarean section scar after skin closure and Group III received Placebo in the form of IV~     fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of~     level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were~     VAS score and the need for additional analgesics. Other parameters were hemodynamic changes~     and occurrence of side effects or complications~   "
20846|NCT02784327|"~     PRF110 is new extended release oily solution formulation of ropivacaine that is intended for~     local infiltration into surgical wounds. The purpose of this study is to determine the~     safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic~     profile of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the~     surgical setting.~   "
20847|NCT02784314|"~     In this observational cost efficacy study, the investigator compare the Laparoscopic Radical~     Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of~     care that include hospitalization related or post operative medical consumption are obtained~     and recorded up to 5 years follow up. Functional results (continence, potency, quality of~     life) are obtained through standardised questionnaires. Carcinologic results are estimated~     by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will~     be made to estimate direct costs of the four postoperative year along with the incremental~     cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary~     continence and erectile function and PSA < 0.2).~   "
20848|NCT02784301|"~     Belly breathing is a popular relaxation technique used to reduce anxiety and pain in~     children during medical procedures. The investigators have developed a biofeedback game that~     will help teach children how to belly breathe in an interactive way. Existing studies have~     shown that biofeedback tools are effective ways to teach relaxation techniques to children.~     The purpose of this study is to evaluate 1) whether this new biofeedback tool is a more a~     effective and engaging way to teach belly breathing to children and 2) whether the~     application is more effective in reducing procedural pain and anxiety compared to standard~     of care, self-directed belly breathing alone or self-directed belly-breathing combined with~     visual distraction. The investigators hypothesize that:~        1. The smartphone-based biofeedback game for belly breathing will reduce self-reported~          procedural anxiety and pain in children during a blood collection procedure compared~          to:~             1. standard of care~             2. belly breathing + standard care procedures~             3. belly breathing with visual components of the application with no coaching or~               biofeedback distraction.~        2. The smartphone-based biofeedback game will increase compliance with belly breathing~          compared to self-directed breathing.~        3. Belly breathing with smartphone-based biofeedback game will be more engaging compared~          to self-directed belly breathing.~   "
20849|NCT02784288|"~     Investigators will determine whether treatment stratification by neck dissection, to more~     accurately pathologically stage patients, minimizing the number of treatment modalities in~     patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.~   "
20850|NCT02784275|"~     This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to~     evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2~     diabetes.~      The study will consist of 3 phases:~        -  Screening phase (2 weeks)~        -  Treatment phase (12 weeks)~        -  Follow-up phase (2 weeks)~      Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria~     will be randomly assigned into one of the following treatment arms:~        -  Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects~        -  Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects~        -  Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects~        -  Dose D: Placebo - 16 subjects~      The assigned dose will be orally administered to subjects once a day before bedtime for 12~     consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their~     respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).~   "
20876|NCT02783924|"~     The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in~     adipose tissue will be studied in 50 subjects.~   "
20851|NCT02784262|"~     Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic~     rhinosinusitis in several ways. Patients have significantly more severe symptom burden and~     worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many~     patients return to the health care providers with persistent symptoms after repeated medical~     and surgical treatment. Patients have usually tried several different types of treatments,~     ranging from less invasive procedures to extensive surgical treatment. The surgical~     treatment is often repeated several times. The most common surgical treatment is functional~     endoscopic sinus surgery, another established procedure is Vidian neurectomy.~      The main object of this pilot study is to investigate the safety of onabotulinumtoxin A~     towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data~     will also be collected to provide indication on whether future placebo-controlled studies~     should be performed.~      Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic~     reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling,~     secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9~     months and will not lead to damage of the nerve.~      This study opens up for improved treatment with less complications.~   "
20852|NCT02784249|"~     The purpose of this study is to compare the safety and efficacy of goniotomy performed with~     a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to~     moderate glaucoma subjects who are also undergoing cataract extraction with~     phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.~   "
20853|NCT02784236|"~     Prospective study of 6 months of evolution in people with type 1 diabetes with insulin~     multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological~     baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control~     (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI),~     treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R),~     quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.~   "
20854|NCT02784223|"~     The purpose of the study is to investigate the contribution of PET-CT with F18-choline in~     the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best~     indication of surgical resection.~   "
20855|NCT02784210|"~     Background:~      Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can~     appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up~     from the outer edge and fill inward. This is called ring enhancement. Researchers think this~     type of lesion may not heal as well as others. Corticosteroids are the standard treatment to~     reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing~     MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose~     course of corticosteroids helps heal those lesions.~      Objective:~      To study the effects of short-term high-dose corticosteroids on ring-enhancing MS.~      Eligibility:~      Adults ages 35 and older who:~      Have MS and a rim-enhancing lesion on a prior brain MRI~      Are enrolled in another NINDS protocol~      Design:~      Participants will be screened under another protocol~      Participants will be randomly assigned to get either no treatment or 3 days of treatment~     with a corticosteroid.~      Participants will have:~      1 baseline visit~      3 dosing visits over 3 days if assigned to get treatment. Participants will get~     methylprednisolone by IV each day. They will get medicine to protect their stomach.~      1 visit each month for 7 months~      Visits include medical history and physical exam. Participants will have blood and urine~     tests. Participants will also have neurological exams and MRIs. Participants lie on a table~     that slides into a cylinder. They are in the scanner 1.5 2 hours. They get a dye through a~     catheter: A needle guides a thin plastic tube into an arm vein.~   "
20856|NCT02784184|"~     Minipuberty is a term used to describe the transient activation of the pituitary-gonadal~     axis 2-3 months after birth in both boys and girls. It is, however, not known why infants~     reach adult levels of reproductive hormones in early life, nor is the exact timing of the~     peak known. Furthermore, what determines the timing of peaks and suppressions of~     reproductive hormones from infancy throughout childhood and into adolescence remains to be~     elucidated.~      The study aims to described and evaluate dynamic changes in the hypothalamic-pituitary-~     gonadal axis in early postnatal life.~   "
20857|NCT02784171|"~     Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show~     that this drug works by helping improve the body's immune response to help fight cancer.~     Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth~     and/or spreading of cancer.~   "
20858|NCT02784158|"~     The purpose of this study is to provide brigatinib for those patients with locally advanced~     and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their~     inability to meet eligibility criteria for on-going recruiting trials, inability to~     participate in other clinical trials (e.g., poor performance status, lack of geographic~     proximity), or because other medical interventions are not considered appropriate or~     acceptable.~   "
20859|NCT02784145|"~     The investigators will investigate the effects of an 8-week resistant starch (RS)~     supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls~     on:~        1. symptoms of constipation (assessed by clinical scores);~        2. fecal short chain fatty acid concentrations (measured by chromatography);~        3. gut microbiota composition.~   "
20860|NCT02784132|"~     Fundoscopy is an important component of the neurological examination as it can detect~     pathologies such as high intracranial pressure. However, the exam can be challenging in~     uncooperative children. This study looked at whether playing a video during eye examination,~     improves the success, duration and ease of pediatric fundoscopy.~   "
20877|NCT02783911|"~     Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and~     Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9~     months and 12 months.~   "
20946|NCT02783014|"~     This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with~     Parkinson's Disease (PD).~      The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB)~     and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional~     MRI).~   "
21675|NCT02773485|"~     The study evaluates impact of high dose radiation on overall survival in patients with~     unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic~     chemotherapy alone and systemic chemotherapy and high dose radiation~   "
20861|NCT02784119|"~     The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and~     endstage liver disease has led to an increase in the gap between patients on waiting-lists~     and available liver grafts. In order to compensate for this scarcity, use of liver grafts~     harvested from extended criteria donors (ECD) has become more and more frequent.~      However, these ECD grafts are known to be associated with a higher rate of primary non~     function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to~     ischemia-reperfusion injury (IRI).~      During OLT, the clamping of the portal vein induces blood congestion in the splanchnic~     territory leading to increased gut permeability, bacterial translocation and release of~     endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.~      Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between~     the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic~     congestion and could therefore decrease IRI and improve liver graft function. However, TPCS~     remains poorly used as no randomised trial succeeds to show its benefit on liver function~     due to lack of power.~   "
20862|NCT02784106|"~     M2951 is an investigational drug under evaluation for treatment of autoimmune and~     inflammatory disorders. The purpose of the study is to assess the efficacy of M2951 in~     subjects with rheumatoid arthritis (RA) currently treated with stable dose of methotrexate~     (MTX).~   "
20863|NCT02784093|"~     Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it~     is the result of chronic or severe constipation and most commonly found in the elderly~     population. Gastrografin is a water soluble contrast mediate that is used as a radiologic~     contrast agent and may be administered orally or rectally. It has been shown to confer a~     therapeutic beneﬁt in adhesive small bowel obstruction (SBO). The investigators speculate~     that gastrografin given enterally may be more effective than enema in the treatment of fecal~     impaction induced intestinal obstruction.~   "
20864|NCT02784080|"~     The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause~     mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection,~     fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d~     stained. The hypothesizes is that donor specific HLA alloantibodies facilitate an immune~     mediated damage to the liver allograft that impairs function and lead to various~     complications.~      The investigators will do a prospective blinded multicenter cohort study in the~     Scandiatransplant organ sharing organization region.~      Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied.~     Blood samples will be taken immediately prior to transplantation, and 14 days, 3 months, and~     1 year after transplantation. All liver biopsies performed during the study period will be~     evaluated for a humoral component and blood samples will be obtained prior to liver biopsies~     to investigate the presence of DSA.~      Investigations will be fully blinded for the treatment responsible doctors.~   "
20865|NCT02784067|"~     S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study~     examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to~     a placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase~     deficiency.~   "
20866|NCT02784054|"~     The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ~     cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and~     autologous stem cell transplantation (HDCT/auto-SCT).~   "
20867|NCT02784041|"~     The purpose of this study is to compare the effect of single adductor-canal-block versus~     single femoral nerve block on the recovery after total knee arthroplasty.~   "
20868|NCT02784028|"~     The digestive cancer is the second cause of death worldwide. The presence of peritoneal~     carcinomatosis is common in the evolution of this type of cancer, as well as increased~     levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low~     sensitivity detection means.~      In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as~     possible associated with an intraperitoneal chemotherapy gave better results but still~     failures associated with the presence of microscopic residual tumors.~      The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of~     small size very easily, in real-time, during surgery (shown in animals).~   "
20869|NCT02784015|"~     To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based~     treatment~   "
20870|NCT02784002|"~     The purpose of this research study is to evaluate the safety and effectiveness of~     Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).~   "
20871|NCT02783989|"~     The present study will assess whether the beneficial effects of a market moderate-alcohol~     drinking in the form of white wine in humans could be derived from the endogenous formation~     of hydroxytyrosol (also known DOPET), a potent dietary anti-inflammatory and antioxidant~     molecule.~   "
20872|NCT02783976|"~     This study will collect and evaluate information on the safety and efficacy of sofosbuvir~     (SOF)-based regimens in routine clinical practice in Mexico. The primary objective of this~     study is to assess the rates of adverse drug reactions (serious and non-serious) in adult~     patients with chronic hepatitis C virus (HCV) infection treated in routine clinical~     practice.~   "
20873|NCT02783963|"~     The purpose of this study is to evaluate the prevalence and morphological features of~     coronary plaques by means of OCT in patients with acute myocardial infarction but without~     any significant coronary stenosis at coronary angiography. In addition, cardiac magnetic~     resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of~     myocardial injury as well as other concomitant findings. As a secondary analysis, the~     association between the distribution and characteristics of coronary plaques detected on OCT~     and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey~     regarding the potential modification of the interventional treatment approach based on OCT~     analysis will be conducted.~   "
20874|NCT02783950|"~     To determine the impact of Decipher test results on adjuvant treatment decisions of~     high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA)~     compared to clinical factors alone.~   "
20875|NCT02783937|"~     Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug.~     Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed~     that these cells are able to regenerate the affected ovary. Studies on mice have shown that~     Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in~     2013, 2014, and 2015).~   "
20878|NCT02783898|"~     Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near~     blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is~     difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and~     symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an~     abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients~     are usually discharged with advice to return to the ED again for a 12-lead ECG should~     symptoms recur. The investigators will recruit 242 adult participants to either study or~     control arms. All study arm participants will be given an AliveCor Heart Monitor and trained~     in the use of the device. Control arm participants will receive standard care only. Both~     groups will be followed-up at 90 days. The investigators believe a smart phone based event~     recorder will allow better and earlier diagnosis in patients with a compatible smart phone~     or tablet, and revolutionise ED care in this area.~   "
20879|NCT02783885|"~     The efficacy and safety of different medications vary from one individual to another and~     from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic~     and pharmacoepidemiology has evolved recently.~      There are multiple examples of oncology drugs being more effective in certain ethnic~     population compared to other. For example, irinotecan combined with cisplatin was very~     effective drug in the management of small cell lung cancer in the Japanese patients while an~     identical study done in the US revealed no major benefit to this combination in American~     population~   "
20880|NCT02783872|"~     This study will investigate neural activation patterns in emotion- and cognition-related~     brain regions during an emotion regulation task involving cognitive reappraisal, and their~     associations with age and pubertal status, among overweight children and adolescents with~     loss of control eating as compared to overweight and normal-weight controls.~   "
20881|NCT02783859|"~     An intervention study to determine if a longer duration of antibiotics (compared to shorter~     duration) improves the short and long term clinical outcomes of children hospitalised for~     pneumonia~   "
20882|NCT02783846|"~     The purpose of this study is to evaluate the effects of different dexmedetomidine on the~     propofol requirement for loss of consciousness undergoing bispectral index.~   "
20883|NCT02783833|"~     Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on~     P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria~     (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P.~     falciparum (Part B).~   "
20884|NCT02783820|"~     This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of~     escalating single doses of reformulated MMV390048 when administered to healthy men and women~     of non-childbearing potential (WNCBP) under fasted conditions (Part A).~   "
20885|NCT02783807|"~     This prospective equivalency study compares the performance of two Ophthalmic Cameras, the~     Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained~     technicians will take pictures of the same patients' retinas and the quality of the photos~     will be evaluated. The study includes healthy patients and patients with a spectrum of~     retinal diseases. The study requires that technicians take pictures of the retinas of adult~     patients between 18 and 80 years of age using both the OC and OP. The pictures will be~     reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is~     equivalent to the OP, based on the quality of the images~   "
20886|NCT02783794|"~     The purpose of this study is to determine whether BP-C1 is effective in the treatment of~     metastatic breast cancer patients who had previously received at least three lines of~     chemotherapy.~   "
20887|NCT02783781|"~     In cardiac surgery, the assessment of operative risk and quality of care is a major~     challenge for both patient, and surgical team. It is also important for health care~     decisionmakers to have predictive tools to compare alternative technics such as conventional~     cardiac surgery and interventional cardiology. Since 1998, the European System for Cardiac~     Operative Risk Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most~     universally used system in this purpose. Its success is the result of a good balance between~     predictive capability and simplicity. It consists almost exclusively of clinical variables.~      However, the objectivity and the predictive ability of some of those clinical items remain~     controversial, particularly those addressing severity of illness for high-risk patients. For~     instance, the degree of priority is submitted to the subjective assessment by the surgical~     team at the time of surgery. Objective data describing the severity of patients arriving in~     the operating room are still missing.~      Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH),~     heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I),~     respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal~     impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen,~     CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and~     nutritional status (albumin).~      In ICU, many scores use biological data to measure, on daily basis, the severity of the~     patient status. Their routine use is simplified by applications available on smartphones.~     They are drawn into hospital information systems.~      In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative~     biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is~     of particular interest because it detects underlying diabetes if unknown (emergent~     situation) or reflects its poor control before surgery. This criterion could be more~     reliable than the simple information of patient treated by insulin (EuroSCORE II criterion).~      Finally, the reinforcement of existing scores with biological variables is recommended by~     the group of recommendations in prognostic research strategy (PROGRESS 2014), rather than~     creating new scores ex nihilo.~      The hypothesis is that adding biological data collected at the time of arrival of the~     patient in the operating room would better qualify the patients' severity condition and~     therefore increase the risk prediction of early mortality and severe morbidity after cardiac~     surgery. The purpose of this study is to test this hypothesis and especially test whether~     the biological data would increase the EuroSCORE II performance, by improving the prediction~     for high-risk patients.~   "
20888|NCT02783768|"~     Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major~     public health importance, as e-cigarette vapor contains established toxicants that as~     hypothesized cause acute damage to the airways and the pulmonary microvasculature that may~     promote the development of CLD, for which there remain few effective therapies.~      The study therefore propose a pilot study using a randomized crossover design in ten healthy~     young adults to test the acute effects of a standardized e-cigarette exposure on two~     sensitive, safe, non-invasive imaging measures: (1) ventilation defects on hyperpolarized~     helium-enhanced magnetic resonance imaging, and (2) pulmonary microvascular blood flow on~     gadolinium-enhanced pulmonary magnetic resonance angiography.~   "
20914|NCT02783430|"~     KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant~     action of ketamine in palliative care situations. Half of participants will receive Ketamine~     and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran~     in combination.~   "
30277|NCT02660801|"~     The objective of the present study is to compare the neuromechanical responses to spinal~     manipulation and spinal mobilization in participants with and without chronic nonspecific~     back pain.~   "
20889|NCT02783755|"~     The purpose of this study is two-fold. First, the investigator will develop a low-literacy~     Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e.,~     therapist manual, patient manual including handouts, and the smartphone materials) as well~     as a beta version of the basic smartphone components with the assistance of experts in the~     field. Next, an iterative development design using focus groups with women who have breast~     cancer and pain accrued from medically underserved areas will be used to refine the~     developed mPCST protocol and basic smart phone components. The protocol—designed to reduce~     cancer pain and disability in patients with low literacy in medically underserved areas—will~     be delivered via tele-video conferencing sessions in the community clinic. The smartphone~     tools (e.g., simple text messages, images, and preloaded intervention content) will allow~     the intervention to extend into the patients' homes. The second study purpose is to pilot~     test the feasibility, acceptability, and efficacy of the developed protocol. The~     investigator will also obtain an estimate of the effect size of the developed protocol to~     decrease pain. Focus group data will be managed and evaluated in a systematic format using a~     grounded theory approach. Data analyses for the pilot testing period of the study will be~     assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests~     will be used to examine pre- to post-intervention differences in pain and the other outcomes~     of interest. There are minimal risk or safety issues related to this study.~   "
20890|NCT02783742|"~     To examine the effect of a coaching intervention on provider burnout and communication~   "
20891|NCT02783729|"~     The primary objective of this study is to demonstrate using polysomnography (PSG) that 10 mg~     lemborexant is superior to zolpidem tartrate extended release 6.25 mg (Ambien CR®) on~     objective sleep maintenance as assessed by wake after sleep onset in the second half of the~     night (WASO2H) after the last 2 nights of treatment in participants 55 years and older with~     insomnia disorder.~   "
20892|NCT02783716|"~     The goal of this study is to determine the role of vascular endothelial function in heart~     failure (HF) and the effect of cardiac resynchronization therapy (CRT) on endothelial and~     cardiac function.~   "
20893|NCT02783703|"~     The study team will investigate the racial differences in the metabolic and clinical~     responses to Medium chain triglycerides (MCT) between African American and Caucasian~     American subjects with Metabolic Syndrome.~   "
20894|NCT02783690|"~     This is an open label phase II randomized controlled trial to determine the safety of 15~     fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in~     patients requiring regional nodal irradiation. Proton therapy is recognized as a standard~     option for the delivery of radiotherapy for breast cancer.~   "
20895|NCT02783677|"~     Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower~     extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and~     necrosis. Amputation may be necessary in severe cases. PAD is also an indicator of future~     cerebrovascular and cardiovascular events. Diabetes mellitus (DM) is one of the major risk~     factors of PAD. Approximately 5% to 10% of diabetic patients have had foot ulceration, and~     1% have undergone amputation. Other risk factors include smoking, old age, male gender,~     hypertension, dyslipidemia, hyperhomocysteinemia and renal insufficiency. Ankle-brachial~     index (ABI) is the most popular tool used to screen PAD. Doppler-derived ankle and brachial~     systolic pressure is obtained. If the ratio is abnormal, further confirmation studies will~     necessary. Although ABI is recommended as one of the screening tests for diabetic~     complications in guidelines, its utility is limited in calcified non-compressible vessels,~     which are common in DM and renal failure patients.~      Digital infrared thermal imaging (DITI) is used to detect surface temperature because~     objects of absolute temperatures higher than zero would radiate electromagnetic waves of~     certain wave lengths according to Plank's law. DITI examination is non-invasive, non-contact~     and fast. Theoretically, temperature of the perfusion area of the occlusive arteries will~     decrease. Investigators will analyze DITI of PAD, and observe the relationship between DITI,~     ABI and vascular duplex examination. The dynamic change of DITI before and after~     percutaneous transluminal angioplasty of PAD will also be observed. Investigators would like~     to evaluate the possibility of the clinical application of DITI for PAD screening.~   "
20896|NCT02783664|"~     This prospective Medical College of Wisconsin Cancer Center study will evaluate stress~     levels in breast cancer patients undergoing genetic testing. It aims to establish baseline~     stress levels, evaluate pre- and post-test stress levels at multiple time points, focus on~     the changes in stress levels for the different resulting subgroups. This will help the~     clinical staff to provide better care for patients both medically and psychologically~     through potential interventions to decrease stress.~   "
20897|NCT02783651|"~     A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in~     the US.~   "
20898|NCT02783638|"~     This study is to assess the pharmacokinetics of Pregabalin controlled release formulation~     after multiple dosing as compared to Pregabalin immediate release formulation and the food~     effect of high fat diet after single dosing in healthy male volunteers.~   "
20899|NCT02783625|"~     The purpose of this study is to test the safety of a study drug called duvelisib.~   "
20900|NCT02783612|"~     Assessing blood glucose control in women with gestational diabetes can be challenging. The~     standard of care remains visual inspection of blood glucose paper diaries of self-performed~     capillary monitoring during regular meeting in High Risk pregnancy clinics.~      The researchers are interested in preforming a randomized control trial comparing women with~     the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital~     monitoring using an application in a Smart-phone and submitting those values via email in~     addition to the regular clinic appointments.~      The Primary outcome of the trial is to assess the compliance of the research group as~     compared to the control group.~   "
20901|NCT02783599|"~     The purpose of this study is to evaluate potential biomarkers and method of action, efficacy~     and safety of olaratumab in participants with soft tissue sarcoma (STS).~   "
20943|NCT02783053|"~     Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective~     trials.~      In this study the researchers aim to investigate the influence of metformin (500 mg 1/day)~     on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy~     lean (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG~     uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure~     before after using metformin.~   "
20902|NCT02783586|"~     The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis~     Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic~     agent to the paravertebral space. It may produce extensive analgesia and better pain~     control.~      Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX)~     by reducing opioids requirements during and after the operation. QLB was not evaluating in~     KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section~     under spinal anaesthesia.~      The aim of this prospective, randomised controlled, multicenter, clinical study is to~     compare the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under~     balanced (general and regional) anaesthesia.~   "
20903|NCT02783573|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY3314814 in participants with mild Alzheimer's disease (AD) dementia.~   "
20904|NCT02783560|"~     Despite the high prevalence of sleep difficulties in children with disruptive behavior~     disorders, little is known about the role of sleep in treating disruptive behavior. The~     current study evaluates the addition of a sleep intervention to an existing parent-training~     program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to~     examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and~     other measures of family functioning, utilizing a variety of self-report and objective~     measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep~     intervention will result in improvements in sleep and disruptive behavior compared to~     control group receiving a highly plausible addition to the standard parent training~     intervention, and that sleep outcomes will moderate overall treatment success.~   "
20905|NCT02783547|"~     This is a Phase 1 clinical trial to evaluate the tolerability of a combination therapy of~     SyB C-1101 (rigosertib sodium) and Azacytidine and to determine the recommended dose of SyB~     C-1101for Phase 2 trial in patients with myelodysplastic syndrome.~   "
20906|NCT02783534|"~     Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal~     anti-inflammatory drug is an effective treatment, there are concerns about serious adverse~     events. Complementary therapies, including acupuncture, are commonly used for PD.~     Acupuncture has a low risk of adverse effects, while the evidence for the effectiveness of~     acupuncture in treating PD is inconclusive. Deqi and psychological factors are core concepts~     in acupuncture theory, but they have been largely neglected in primary dysmenorrhea clinical~     reports. The objective of this trail is to assess the clinical efficacy of acupuncture in~     the prevention of PD and investigate what factors will affect the efficacy of~     acupuncture.The results of this trial will significantly add to the current body of evidence~     on the role of acupuncture for PD. If found to be effective and safe, acupuncture will be a~     valuable treatment option in the prevention of PD. In additional, results from this trial~     will identify what factors will affect the efficacy of acupuncture.~   "
20907|NCT02783521|"~     The investigators propose to 1) assess the feasibility, acceptability and preliminary~     efficacy of a gender- and culturally-sensitive weight loss intervention in 48~     overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant~     characteristics and process measures related to the uptake of mobile-health (mHealth)~     technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic~     changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a~     non-invasive MRI as a therapeutic response biomarker.~   "
20908|NCT02783508|"~     Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief~     during labor. The aim of the current study is to evaluate the efficacy of systemic pethidine~     compared to N2O given for pain relieve in term, multiparous women in labor.~   "
20909|NCT02783495|"~     This pilot trial of this iPad-based intervention in glioma patients at University of~     California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to~     support a funding application for a larger clinical trial. Twenty patients with stable~     low-grade gliomas will complete a computerized battery of standardized neurocognitive tests~     and quality of life assessments at baseline. Subjects will complete the intervention at home~     over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline.~     Subjects will also complete a post-intervention questionnaire on the usefulness,~     attractiveness, difficulty and burden of the intervention. Clinical data will be collected~     at the time of each assessment. This will include diagnostic and treatment history, magnetic~     resonance imaging (MRI data), tumor genomics and immunohistochemistry.~   "
20910|NCT02783482|"~     The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune~     Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency~     (PHID).~   "
20911|NCT02783469|"~     In 1997, the global prevalence of diabetes was estimated to be 125 million and this has~     risen to around 400 million in 2015. In addition diabetes has a number of complications~     including heart disease, blindness, kidney failure and amputation. This represents a~     significant burden on healthcare services. Type 2 diabetes (T2D) is caused by a combination~     of genetic and environmental factors. The aim of GoDARTS is to recruit participants with T2D~     to a registry to provide a platform with which to investigate the genetics of T2D, its~     complications and response to treatment. This study will investigate the genetic basis of~     diabetic neuropathic pain.~   "
20912|NCT02783456|"~     Epidemiological studies have found a link between aircraft noise exposure and increased~     incidence of arterial hypertension and thus cardiovascular disease. The underlying~     pathophysiological mechanisms are not yet fully understood. The kidney acts as a long-term~     regulator of blood pressure and controls the extracellular sodium and water balance.~     Significant renal mechanisms of blood pressure regulation are the renin angiotensin system,~     renal sympathetic activity and sodium excretion. Animal work and clinical studies show that~     mental stress affects the renal plasma flow and urinary sodium excretion. The investigators~     observed a lower sodium excretion in situations of mental stress in subjects at risk for~     developing arterial hypertension. In healthy volunteers, a 30-minute mental stress test~     resulted in increased glomerular filtration rate, filtration fraction and an increase in~     urinary sodium excretion. In this pilot study the investigators analyzed the influence of 30~     minutes standardized aircraft noise on renal and central hemodynamics.~   "
20913|NCT02783443|"~     Observational study evaluating effect general or regional anaesthesia on glycocalyx by using~     perfused Boundary Region in sublingual microcirculation.~   "
20915|NCT02783417|"~     The use of antiretroviral therapy (ART) could prevent depression of the immune system of~     patients harboring with Human Immunodeficiency Virus (HIV), providing increased life~     expectancy, changing the classification of HIV / AIDS into a chronic illness. However~     prolonged use of ARTincreases the prevalence of lipodystrophy syndrome (SL), characterized~     by inadequate distribution of body fat and changes in lipid profile, associated with a~     significantly increased cardiovascular risk, among others. The practice of strength training~     (ST) helps in controlling SL, providing improved lipid profile and the quality of life of~     these patients. However, due to increased cardiovascular risk and physical weakness~     resulting from SL, the ST with vascular occlusion (STOV) could be a viable alternative~     training, to use low load (10-30% of maximal work capacity) with similar benefits ST~     traditional (STT), as already proven in other populations. The STOV is justified by the~     lower neuromuscular overhead, increasing the number of patients able to participate in this~     complementary therapy. The objective was to assess the impact of the combined strength~     training with vascular occlusion on SL and the skeletal muscle tissue in people harboring~     with HIV/Aids.~   "
20916|NCT02783404|"~     Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at~     risk of infective endocarditis, expert committees continue to publish recommendations for~     antibiotic prophylactic regimens. Recently, the investigators have evaluated the efficacy of~     the intravenous administration of 1000/200 mg of amoxicillin/clavulanate for the prevention~     of bacteraemia following dental extractions. The results of this study suggest that is~     highly effective, and that it might be considered a first-line choice for patients at~     high-risk for infective endocarditis who undergo dental procedures and for whom~     antimicrobial prophylaxis is recommended. This new project aims to evaluate the~     effectiveness of oral amoxicillin/clavulanate in preventing post-dental extraction~     bloodstream infection.~   "
20917|NCT02783391|"~     New method for speech area cartography in patient individual cortical anatomy in view of~     improving functional area limit preservation during surgery.~   "
20918|NCT02783378|"~     At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours.~     During the first 24 hours are the measurements without medication. After 24 hours the~     treatment will be started with Gaviscon and will the next 24 hours the measurements under~     the medication happen. Normally is the medication required after the measurements. With this~     study the investigators will have multiple measurement points to compare.~   "
20919|NCT02783365|"~     There are an estimated 100 million Americans with chronic pain. The enormity of the problem~     at the societal level is staggering, not simply in terms of its sheer prevalence but also~     the societal costs, including health care expenditures, disability compensation, lost~     productivity, and lost employment potential. The pharmacological focus in treatment tends to~     give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or~     worse, they are perceived to have an imaginary illness. It is argued that these stigmas not~     only negatively affect the patients' healthcare experience, but also perpetuate maladaptive~     coping. In addition, it is suggested that reliance on pharmacological approaches have~     contributed to the rate of overdoses from prescribed opioids. In order to address this~     burden facing society, patients need opportunities to foster a sense of self-efficacy to~     manage their pain, as well as improve their healthcare experience by allowing them to~     dialogue with their clinician openly and freely about their chronic pain, and coping~     strategies.~      This study is designed to explore the impact of an intervention using photo-elicitation~     (based on Photovoice) and online group support (via Facebook) on participants' overall~     experience of chronic pain and patient-identified areas of function. Photovoice participants~     will utilize cameras that enable them to record issues related to their experiences, and~     subsequently display them. This method serves as an empowering tool to connect participants~     to key stakeholders in the community, facilitates change and opportunities that otherwise~     would not be available to marginalized groups.~   "
20920|NCT02783352|"~     Increasing the success rate of rotator cuff healing remains a tremendous challenge for~     orthopedic surgeons, which encourage the development of new biological therapies. Among many~     approaches, activating resident progenitor cells with the Lipogems® product could be an~     easy, safe, practical and cost-effective new therapeutic strategy for increasing rotator~     cuff tendon healing.~      The primary goal of this study is to evaluate efficacy of infiltration of autologous~     micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in~     post-operative Constant score.~   "
20921|NCT02783339|"~     The primary objective of this study is to demonstrate effectiveness and safety of the~     NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial~     aneurysm treatment.~   "
20922|NCT02783326|"~     Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic~     state due to an inflammatory response that leads to limitation in lung function of the~     individual, providing symptoms such as dyspnea, nutritional changes, decreased strength~     respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic~     function with decreased heart rate variability. Have objective to evaluate and compare the~     effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in~     the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes,~     between 50 and 70 years old. Data collection and application of the Protocol will take place~     at the Clinical School of Physiotherapy and Occupational Therapy at the University of the~     Amazon (UNAMA). Between January and February 2015.~   "
20923|NCT02783313|"~     The objective of this study is to determine if pooled buffy coat-derived pathogen reduced~     plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet~     concentrates in terms of WHO bleeding complications in hemato-oncological patients with~     thrombocytopenia.~   "
20944|NCT02783040|"~     To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of~     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)~     and digoxin (P-gp probe drug)~   "
20947|NCT02782988|"~     CMV lesions were found in the olfactory system of children with congenital CMV infection but~     no study has hitherto examined the impact of congenital CMV infection on olfaction. So the~     investigators propose in this study to assess the proportion of children with olfactory~     deficits among children with congenital CMV infection. Second this study will also evaluate~     performances of a new olfactory test, based on discrimination of binary odorant mixtures.~   "
20924|NCT02783300|"~     The study drug, GSK3326595, is an inhibitor of protein arginine methyltransferase 5 (PRMT5)~     that potently inhibits tumor growth in vitro and in vivo in animal models. This first time~     in human (FTIH), open-label, dose escalation study will assess the safety, pharmacokinetics~     (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in subjects~     with advanced or recurrent solid tumors, as well as clinical activity in subjects with a~     subset of solid tumors and non-Hodgkin's lymphoma. This is an open-label, repeat-dose,~     multicenter, 2-part study to establish the maximally tolerated dose (MTD)/ recommended phase~     2 dose (RP2D) based on safety and tolerability and preliminary clinical efficacy of~     orally-administered GSK3326595.~      Part 1 is a dose-escalation phase to identify the MTD/RP2D based on the safety, PK, and PD~     profiles observed after oral administration of GSK3326595. This Part will be conducted in~     adult subjects with relapsed and/or refractory solid tumors. It is estimated that up to 42~     subjects will be enrolled into the dose escalation cohort of the study, including up to 30~     subjects to identify the MTD and approximately 12 subjects in the PK/PD/metabolite/biomarker~     expansion cohort(s).~      Disease-specific expansion cohorts (Part 2) are planned to further explore clinical activity~     of GSK3326595 in subjects with selected solid tumors and non-Hodgkin's lymphomas. It is~     estimated that up to 138 subjects will be enrolled in the disease-specific expansion cohorts~     of the study.~      The duration of study will depend on recruitment rates and the timing of subjects' duration~     on study (withdrawal rates due to toxicity or progression), with an approximate duration of~     2 years.~   "
20925|NCT02783287|"~     The purpose of this study is to assess the impact of text message reminders on adherence to~     medications and exercise in patients recently discharged from the hospital after a~     myocardial infarction (MI).~   "
20926|NCT02783274|"~     Two-year (2 year) information regarding the performance of the commercially available Actis™~     Total Hip System in order to obtain and evaluate the clinical outcomes on a series of~     cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using~     clinical, radiographic and device and procedure related adverse event assessments.~   "
20927|NCT02783261|"~     Patients undergoing Y90 radioembolization to will be followed prospectively with CT~     volumetry to determine post-Y90 rate of liver hypertrophy.~   "
20928|NCT02783248|"~     The aim of this study is to validate prospectively the predictive score of late results~     about a diverse population recruited in France and to evaluate the contribution in~     predicting the outcome of the PMC scanner to study the mitral calcium score and the location~     of the calcifications.~   "
20929|NCT02783235|"~     This study aims at creating video-based tutorials for developing skills in performing~     cervical cancer screening using VIA for the Auxillary Nurse Midwives (ANMs), Accredited~     Social Health Activists (ASHAs) and Primary Health Workers (PHWs). Cervical cancer screening~     is mainly done by the following three methods: Visual inspection with acetic acid (VIA),~     Cervical Smear Cytology (PAP) and HPV DNA test. VIA is a low cost, low resource cervical~     cancer screening method and especially useful for low middle income countries (LMICs) like~     India.~      We propose to develop video-based tutorials, such that the ANMs/ASHAs/PHWs could be trained~     in performing and interpreting VIA with the use of this tutorial. The ANMs/ASHAs/PHWs have~     important roles in delivering health in rural/ semi urban areas and they will be trained~     using this tutorial.~      The video-based tutorials will be made according to the 'Spoken Tutorials' methodology,~     developed at IIT Bombay. Video-based Tutorials has given skills based training to over 2~     lakh students in the past four years on IT based topics. The tutorials are made available~     online free of cost. They are designed to be used without the need of an expert being~     physically present.~   "
20930|NCT02783222|"~     This is a randomized study evaluating the efficacy and impact on function of two different~     doses of nab-Paclitaxel in elderly patients with advanced breast cancer.~   "
20931|NCT02783209|"~     This study evaluates the association between surgery of the cataract and posterior vitreous~     detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in~     the same group of patients~   "
20932|NCT02783196|"~     This study is undertaken to search whether glucagon-like peptide-1 (GLP-1) analogue,~     Liraglutide, by enhancing clock gene and AMPK-SIRT-1 mRNA expression, may reverse the~     metabolic abnormalities of type 2 diabetes, improving overall glycemic excursion,~     inflammatory cytokines and β-cell function in type 2 diabetes individuals.~      The investigators aim is to compare the effect of 40 days treatment with Liraglutide (LIR)~     vs. 40 days with placebo (PLA) in T2D participants on the following end points:~      Primary end-points:~        -  Change in the oscillation of CG (i.e. CLOCK, BMAL1, Per1, Per2, Cry1, Cry2,~          Rev-erb-alpha Ror-alpha), AMPK, SIRT1 and inflammatory cytokines mRNA expression in~          white blood cells (WBCs).~      Secondary end-points:~        -  Overall daily glycemic variation assessed with continuous glucose monitoring system~          (CBMS)~        -  Serum levels of inflammatory cytokines (TNF-α, IL-1β, IL-6)~        -  β-Cell function derived from glucose and insulin response to OGTT~   "
20933|NCT02783183|"~     The purpose of this trial to compare the pharmacokinetic characteristics of~     YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled~     release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and~     AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.~   "
20934|NCT02783170|"~     This is a pilot, prospective, randomized, open-label clinical trial. During the study,~     pregnant women will be randomized (1:1) to receive co-administration of a single~     intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a~     single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria~     toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the~     vaccines (IIV followed by Tdap ~ 21 days later). Vaccines will be administered by licensed~     study personnel.~      Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review~     when possible.~      Injection-site (local) and systemic reaction data will be assessed on vaccination day and~     during the 7 days following vaccination using either identical web-based or paper diaries,~     depending on study participant preference.~      Maternal serum samples will be collected for antibody titers relevant to the Tdap and~     Influenza at time points that include: prior to vaccination(s), ~21 days post~     vaccination(s), and at delivery. Additionally, cord blood serum will be analyzed for the~     same antibody titers.~      Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained~     from medical record review.~   "
20935|NCT02783157|"~     In this study, the investigators aim to determine whether non-invasive autonomic modulation~     decreases inflammation and complications after thoracic surgery. The investigators will test~     the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major~     thoracic surgery reduces inflammation and complications, particularly postoperative atrial~     fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients~     undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via~     either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized~     to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All~     patients will receive standardized anesthetic, surgical, and post-surgical care. The primary~     outcome in this study will be time to occurrence of in-hospital POAF, which will be compared~     between groups using Cox proportional hazards models. Secondary outcomes will be ICU and~     hospital length of stay, postoperative morbidity, postoperative mortality, and serologic~     markers of inflammation.~   "
20936|NCT02783144|"~     Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block~     Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.~   "
20937|NCT02783131|"~     It is well known that medical errors account for a large amount of patient harm within the~     hospital setting. This is a significant problem within the emergency context. A system that~     acts as a prompt, guide and scribe for the obstetric emergency has been developed called~     'Mednav'. Mednav is a navigation device for the management of medical emergencies; developed~     at Chelsea and Westminster Hospital since 2010. This is a device which acts similar to a~     satellite navigation devices in the automobile industry navigating you from A to B, MedNav~     navigates the clinician from the unwell patient to the well patient.~   "
20938|NCT02783118|"~     Depression is one of the major challenges worldwide, with significant increasing personal,~     economic, and societal costs. Although empirically supported treatments have been developed,~     they are not always available for patients in routine clinical care. Even when patients are~     adequately treated, they do not always respond to treatment and/or face a significant risk~     for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of~     the very first depressive symptoms are necessary. Mental health apps could prove a valuable~     alternative for that. Although preliminary research has indicated that apps could be useful~     in treating depression, no study has attempted to test their utility in preventing~     depression symptoms. The current study aims to contrast the efficacy of a smartphone app in~     preventing depression compared against a waiting list condition. The app includes self-help~     materials and exercises based on cognitive behavioral therapy (CBT) for depression,~     presented in a tailored manner and incorporating gamification elements aimed at boosting the~     motivation to use the app.~      This study protocol is the first that capitalizes on the ubiquity of smartphones to~     large-scale dissemination of CBT-based strategies aimed at preventing depression in~     nonclinical populations. The objective of this study is to test an app designed to decrease~     general cognitive vulnerability and promote engagement in protective, adaptive activities,~     while counteracting the tendency of premature dropout (through gamification and~     customization).~   "
20939|NCT02783105|"~     Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain~     injury and concerns up to 30% of severely brain-injured patients.~      PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges~     causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer~     more pain, more cardiovascular distress, more infections and prolonged rehabilitation and~     mechanical ventilation; additionally it could lead to a worse outcome.~      Classical music was shown to reduce autonomic nervous system imbalance in healthy people and~     in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured~     patients presenting with PSH, as well.~      Our study aims at demonstrating that early musical intervention, started with the weaning of~     sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic~     hyperactivity in traumatic brain-injured patients.~   "
20940|NCT02783092|"~     The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol~     administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive~     patients; that is, participants with at least 50% decrease in the frequency of epileptic~     seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).~      Primary end point(s): Rate of responsive patients; that is, participants with at least 50%~     decrease in the frequency of epileptic seizures in the last month of the trial relative to~     baseline (pretreatment with AEDs only).~   "
20941|NCT02783079|"~     This study looks at two different interventions used for the treatment of insomnia in~     survivors of breast, colon, lung, prostate and gynecologic cancer.~   "
20942|NCT02783066|"~     Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes.~     While most of these ulcers can be treated successfully, some will persist and become~     infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic~     ulcers will require amputation of the affected limb, resulting in staggering costs for both~     the patient and the healthcare system. Prevention by identifying people at higher risk is~     key for better clinical management of such patients. It is not uncommon for patients~     suffering from diabetes to have concomitant lower extremity edema or venous insufficiency~     and they subsequently may benefit from graduated compression. However, because of the common~     association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians~     are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and~     possibility of gangrene.~      A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot~     Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The~     device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and~     offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates~     back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The~     offloading boot design holds the foot and lower leg in a position that reduces shear and~     friction forces and provides a reduction in plantar pressure.~      The PulseFlow DF is designed to record how many hours of blood pumping it has delivered.~     This data will be downloaded at each clinic visit. The boot cannot pump blood around the~     participant's foot unless fitted correctly and the battery is charged up overnight.~      The purpose of this study is to conduct an interventional study study with N=15 diabetic~     subjects with active foot ulcers to assess whether PulseFlow foot compression device can~     help improve lower extremity perfusion, whilst improving balance and spatio-temporal~     parameters of gait.~      The key goals of the proposed project are to test whether a specially designed compression~     device can improve lower extremity perfusion, whilst also simultaneously improving the~     balance and walking performance. Investigators envision the use of this specially designed~     offloading device with compression capability will help reduce the incidence of diabetic~     foot ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed~     device might enhance daily physical activity as well as walking performance. Investigators~     will conduct a prospective clinical study to validate these hypotheses. Potential changes in~     walking and spontaneous daily physical activities will be assessed using validated~     technologies that include walking analyzer system, balance assessment using body worn~     sensors, and computerized pressure insoles.~   "
20948|NCT02782975|"~     The primary objectives of this study are to evaluate the absolute bioavailability of a~     single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based~     intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK)~     profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability~     of aducanumab administered via SC and IV routes in healthy participants and to characterize~     additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose~     in healthy participants.~   "
20949|NCT02782962|"~     This study evaluate the diagnostic accuracy of a simplified clinical algorithm (STANDING)~     for the differential diagnosis of acute vertigo in the emergency department.~      In particular, the investigators want to analyze the sensitivity and specificity of the test~     for the diagnosis of vertigo of central origin and the reproducibility of the test.~      In suspected central vertigo of ischemic origin, a duplex sonography to identify vertebral~     artery pathology will be performed.~   "
20950|NCT02782949|"~     This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer~     in patients with chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin~     is an antioxidant compound found in plants that may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
20951|NCT02782936|"~     Background: The gas mask is used to protect military and non-military subjects exposed to~     respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the~     gas mask on respiratory patterns and indexes of the respiratory effort. Methods: We are~     completing our study with 14 healthy subjects to evaluate breathing patterns, index of~     respiratory efforts and blood gases. Seven conditions have been tested in a randomized~     order: at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and~     during induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada).~     Airway pressure, inspiratory and expiratory flows were measured. An esophageal catheter was~     introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate~     indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary~     blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data~     of the last 2 minutes at a steady state were considered for analyses. Results: The~     preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the~     gas mask and without, most of the respiratory index increased in the tested conditions (at~     rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject~     the indexes of effort were higher with the gas mask, a statistical trend was observed with~     the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s;~     p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the~     respiratory index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65;~     p=0.04; SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing~     pattern and arterial blood gases data with and without mask. Data for induced hypoxemia are~     under analysis. We measured on bench the inspiratory and expiratory resistances of the~     tested gas mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances~     = 0.9 cmH2O at 1 L/sec). This may explain in part the increased work of breathing with~     masks. Conclusions: This study demonstrated an increase of the indexes of respiratory effort~     during an exercise with the gas mask. This study is the first to directly assess the indexes~     of efforts with esophageal pressure in this situation. Our results and method may be used as~     a reference for evaluating tolerance with different designs of gas masks.~   "
20952|NCT02782923|"~     This is a single-center, prospective controlled simulation study designed comparing and~     evaluating the driving performance of subjects who have had cervical spine surgery and the~     use of a validated driving simulator. To date, there haven't been evidence-based~     recommendations to determine a patient's fitness to drive in the peri-operative or~     postoperative state. The objective of this study is to delineate the effect cervical spine~     procedures have on driving performance in the peri-operative time period. The study will~     take place at New York University Langone Medical Center - Hospital for Joint Diseases which~     will include the surgeries. The follow up visits will be at the NYU Center for~     Musculoskeletal Care.~   "
20953|NCT02782910|"~     Bipolar disorders are severe chronic disorders, marked by recurrent episodes of depression~     and (hypo)mania. The disorder usually emerges in early adulthood and tends to have a highly~     unpredictable course. Prevention of these episodes is essential, as they are associated with~     marked impairment in social and occupational functioning. The investigators propose to~     conduct a randomized, multi-center, observer-blind, parallel group controlled trial with an~     78 week (18 month) intervention phase to test the hypothesis that continuous ambulatory~     real-time monitoring of early warning signs for new depressive or (hypo)manic episodes by~     smartphone based, innovative technology (e.g. GPS, acceleration sensor), including~     individual threshold- based early intervention for these early warning signs, will prolong~     time to a new mood episode and reduce hospitalizations (intervention group). In the control~     group ambulatory monitoring of early warning signs for emerging depressive or (hypo)manic~     episodes will occur in an identical manner, but the results will not be transmitted to the~     treating psychiatrist. All patients in this trial, irrespective of their group assignment,~     will receive guideline-based, state-of-the-art maintenance treatment.~   "
20954|NCT02782897|"~     This pilot study aims to investigate whether intravenous immunoglobulin is safe and~     effective in alleviating perihematomal edema and neurologic deficits in patients with~     intracranial hemorrhage.~   "
20955|NCT02782884|"~     Patients undergoing approximately 10 common outpatient general surgical operations will be~     given a narcotic prescription for a specified number of pills.~      Inpatients who are about to be discharged after surgery or trauma will be given narcotic~     prescriptions for a specified number of pills. Patients will be given a patient report form~     which they will use to record the number of pills they take each day and their daily pain~     score on a scale of 0-10.~   "
20956|NCT02782871|"~     Following major head and neck surgery it may be necessary to keep patients intubated and~     ventilated for at least 12 hours to allow the swelling associated with the operation to~     subside. Therefore patients (participants) are transferred to the intensive care unit~     anaesthetised, in-tubated and ventilated. Current practice is that patients are manually~     ventilated, by hand, during transfer from the operating theatre to the intensive care unit.~   "
20957|NCT02782858|"~     The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the~     human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a~     critical role in multiple sclerosis (MS).~      This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics~     of GNbAC1 in patients with relapsing remitting multiple sclerosis.~   "
20958|NCT02782845|"~     This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile~     and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or~     immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be~     administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last~     dose of CT or ICT in each treatment cycle.~   "
20986|NCT02782572|"~     This project deals with exercise in acute heart failure in three different groups~     (conventional medical treatment; exercise with non-invasive ventilation and exercise with~     placebo of non-invasive ventilation).~   "
20959|NCT02782832|"~     This study analyse the need for neuromuscular blockade in consecutive routine laparoscopic~     procedures without standard use of neuromuscular blockade in an ambulatory laparoscopic~     surgery setting and analyse specific reasons for using neuromuscular blockade in individual~     patients. Furthermore, the study report the analgesic use in postoperative care unit and the~     discharge rate.~   "
20960|NCT02782819|"~     Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution~     is the current recommended initial fluid resuscitation. However, this kind of fluid has high~     volume of distribution and may require large volume administration before achieve~     therapeutic goal of shock reversal. There are rising concern about the delay in shock~     reversal and adverse consequences of large amount volume of fluid therapy. Colloid fluid~     have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid~     resuscitation and promote shock reversal. Whether colloid infusion can improve shock~     reversal rate and decrease complication associated with fluid resuscitation, had~     inconclusive information.~   "
20961|NCT02782806|"~     The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared~     to hemoglobin measurements obtained from a laboratory hematology analyzer.~   "
20962|NCT02782793|"~     A prospective outcomes study in patients referred for endoscopic mucosal resection of~     complex colon polyps.~   "
20963|NCT02782780|"~     Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because~     there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and~     daily functioning, this study will investigate whether a type of behavioral sleep treatment~     called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI.~     CBTi is a multicomponent treatment where patients learn about sleep and factors affecting~     sleep as well as how to alter habits that may impair or even prevent sleep. The~     investigators hypothesize that helping Gulf War Veterans learn how to achieve better sleep~     with CBTi may also help to alleviate their other non-sleep symptoms of GWI.~   "
20964|NCT02782767|"~     Comparison of efficacy in management of pain in abdominal surgery between epidural versus~     wound infusion catheter {catheter placed within the incision site}~   "
20965|NCT02782754|"~     The purpose of this study is to evaluate the outcome of intracranial germinoma treated with~     chemotherapy plus reduced radiotherapy.~   "
20966|NCT02782741|"~     Primary Objective:~      To determine the effect of neoGAA (GZ402666) treatment on respiratory muscle strength~     measured by percent predicted forced vital capacity (% FVC) in the upright position, as~     compared to alglucosidase alfa.~      Secondary Objective:~      To determine the safety and effect of neoGAA treatment on functional endurance (6-minute~     walk test (6MWT), inspiratory muscle strength (maximum inspiratory pressure (MIP)),~     expiratory muscle strength (maximum expiratory pressure (MEP)), lower extremity muscle~     strength (hand-held dynamometry (HHD)), motor function (Quick Motor Function Test (QMFT)),~     and health-related quality of life (SF-12).~   "
20967|NCT02782728|"~     This pilot study will evaluate a computer-based intervention titled Trauma-informed~     Personalized Scripts (TIPS). The goal of this intervention is to improve patient-provider~     communication about sensitive topics such as intimate partner violence (IPV) and~     reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family~     planning clinics using a randomized study design to compare the basic version of TIPS (a~     computer-based assessment with provider scripts only) to an enhanced TIPS containing a~     tailored brief intervention for patients along with provider scripts. The investigators plan~     to recruit 240 female patients ages 16-29 for this study.~   "
20968|NCT02782715|"~     The specific aims of this study are:~        1. To determine the safety and feasibility of treating patients with a combination of MRI~          guided stereotactic body radiation therapy and microwave ablation.~        2. To assess short and long-term toxicity rates of patients treated with a combined~          modality approach.~        3. To assess local control, survival, and pathologic response to treatment~   "
20969|NCT02782702|"~     Hailey Hailey and Darier disease are rare genetic dermatoses. Mutations of 2 genes (ATP2C1~     or ATP2A2 respectively) are responsible for the diseases. These genes have a key role in~     calcium pump; their defect create abnormal link between keratinocytes' desmosomes and induce~     skin lesions. Clinically, patients present with inflammatory lesions located in the folds.~     Quality of life is impaired because of pain, pruritus and tendency to infections. Lesions~     are permanent but acute exacerbations occur in hot seasons because of increased sweating.~     Usual therapies are often not effective (local treatment, laser, phototherapy). Because~     sweating is a well established inducing or aggravating factor, botulism toxin could be an~     effective treatment for these diseases.~      Botulism toxin is already used in clinical practice and acts via a decreased sweet~     secretion. Improvement of skin lesions in Hailey-Hailey or Darier diseases has been~     previously reported in a few cases but there is no study properly evaluating the benefit of~     such treatment.~      The aim of the project is to study the improvement of quality of life for patients suffering~     from Hailey-Hailey or Darier diseases after a injections of botulism toxin in large skin~     folds. The principal objective is to estimate the distribution of the variation of quality~     of life at M1 vs. baseline.~   "
20970|NCT02782689|"~     The primary objective of this study is to demonstrate the non-inferiority of the 2-layer~     compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the~     treatment of venous leg ulcers in terms of complete healing at 16 weeks.~   "
20971|NCT02781870|"~     This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and~     12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of~     non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh~     placement versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic~     treatment of groin hernias.~      A total of 100 male and female patients will be entered in the trial in Maria Middelares~     Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the~     department of surgery will screen all eligible consecutive patients for inclusion in the~     study. They will inform all patients about the surgery and the follow-up with MRI scan~     thereafter.~   "
20972|NCT02781857|"~     To answer the question whether a disease specific profile of breath in patients with lung~     cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by~     mass spectrometry.~   "
20973|NCT02781844|"~     This study is being conducted to characterize the effects of twice daily administration of~     rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions, and safety and~     tolerability over the course of 24-36 hours as compared with the current once daily dosing~     regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara®).~   "
20974|NCT02781831|"~     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted~     gait training system for stroke survivors. It is anticipated that robot-assisted gait~     rehabilitation in combination with standard hospital based rehabilitation will achieve~     significantly better gait outcomes than standard hospital based rehabilitation alone.~   "
20975|NCT02781818|"~     Purpose: To evaluate the effectiveness of intralesional triamcinolone for the treatment of~     hidradenitis suppurativa~      Participants: Patients diagnosed with Hidradenitis Suppurativa that have active inflammatory~     HS lesions. Up to 60 lesions will be treated. Between 20 and 60 patients will be enrolled~     dependent on the number of lesions they have treated. (up to 3 per patient)~      Procedures (methods): Injection of triamcinolone or placebo into active lesions of~     hidradenitis suppurativa~   "
20976|NCT02781805|"~     The goal of this study is to mechanistically define the potential anticancer activities of~     the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn~     novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as~     well as epithelial breast cell differentiation of high-risk women. To this end, we have~     designed a BP window trial to examine the effect of 1 - 3 weeks administration of~     alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and~     mammary epithelial cell differentiation.~   "
20977|NCT02781792|"~     Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in~     glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its~     activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as~     well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life~     of this drug and known oscillations in DNA damage repair make it an ideal candidate for~     chronotherapy.~      Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and~     maximizing efficacy through delivery of a medication according to the timing of biological~     rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side~     effects and increase in anti-tumor activity for a variety of cancers, but has never been~     applied to the treatment of gliomas.~      Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of~     intracranial glioma xenografts and the success of chronotherapy in the treatment of other~     cancers, the invesitgators hypothesize that the timing of TMZ treatment will alter its~     efficacy and toxicity.~   "
20978|NCT02781779|"~     The purpose of this study is to learn how effective each of the two dressings, Silverlon®~     and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED)~     procedure wound infections.~   "
20979|NCT02782663|"~     This is a open-label extension (OLE) study designed to evaluate the long-term efficacy,~     safety, and tolerability of ABT-494.~   "
20980|NCT02782650|"~     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm~     birth including current and preferred counseling, barriers and facilitators for preferred~     counseling from both obstetricians and neonatologists, as well as parents' views on this.~      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with~     parental consent) but as some international guidelines, the Dutch guideline lacks detailed~     recommendations on organization, content and preferred decision-making of the counseling.~   "
20981|NCT02782637|"~     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm~     birth including current and preferred counseling, barriers and facilitators for preferred~     counseling from both obstetricians and neonatologists, as well as parents' views on this.~      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with~     parental consent) but as some international guidelines, the Dutch guideline lacks detailed~     recommendations on organization, content and preferred decision-making of the counselling.~   "
20982|NCT02782624|"~     To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once~     daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered~     orally~   "
20983|NCT02782611|"~     Over the past several decades, a new science of subjective well-being has produced insights~     into the factors that make people happy—from cultivating strong relationships to pursuing~     the right goals. Drawing on these empirical findings, the investigators created a~     comprehensive 12-week intervention program, ENHANCE: Enduring Happiness and Continued~     Self-Enhancement. The investigators multimodal program is designed to teach people essential~     skills in order to produce sustainable changes in behavior and, as a result, long-lasting~     increases in happiness. To test the effectiveness of ENHANCE, the investigators designed a~     six-month randomized clinical trial. Participants will be assigned to an active treatment~     group or a waiting group control. They will complete baseline assessments, and follow-up~     assessment at three and six months after the start of the intervention. These assessments~     will contain measures of subjective well-being and objective measures of health, as well as~     a variety of psychological mediators (e.g., psychological needs) and moderators (e.g.~     personality). The investigators will thus be able to explore not only whether ENHANCE works~     to improve well-being, but also why and how ENHANCE works.~   "
20984|NCT02782598|"~     The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to~     improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy~     (CRT) patients.~   "
20985|NCT02782585|"~     Manual therapy (MT) techniques applied over cervical region have over both local (neck) and~     distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological~     mechanisms are hypothesized to explain the underlying effects, with effects originating from~     peripheral mechanisms, spinal cord and supraspinal mechanisms.~      There is also an increasing interest in the study of the role of psychological variables in~     the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or~     kinesiophobia are related to poor prognosis in the development of pain outcomes and~     disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested~     models in this field.~   "
20987|NCT02782559|"~     Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant~     management for the treatment of preterm preeclampsia~   "
20988|NCT02782546|"~     This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia~     free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this~     extremely high-risk patient cohort (based on the institutional experience using~     non-myeloablative / reduced intensity conditioning in a similar patient cohort).~      A formal safety evaluation will be done after every 6th patient enrolled and the trial will~     be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any~     grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).~   "
20989|NCT02782533|"~     Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity~     treatment.~   "
20990|NCT02782520|"~     This study is a phase III, randomized, controled, parallel groups, single blinded, clinical~     trial that aims at comparing the improvement of right ventricular function after~     administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.~      Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under~     cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.~      Patients needing fluid expansion in the first three hours after surgery will be randomized~     in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic~     saline solution (3 mL/kg).~      Right ventricular function measured with Swan Ganz catheter, 30 minutes and one hour after~     fluid expansion will be the primary outcome.~   "
20991|NCT02782507|"~     The study is a pilot study of Cognitive therapy for people with psychosis who have~     distressing visual hallucinations. The aim is to evaluate whether this is an acceptable,~     feasible and effective treatment. This is a pilot study and there is no randomisation to~     either CBT or treatment as usual (TAU). If a participant is allocated to the cognitive~     therapy plus TAU condition then the participant will meet with a therapist on initially a~     weekly basis and receive up to 8 sessions of CBT over a 2 month period. The participant will~     also have regular assessments conducted by a researcher who is independent to the treatment~     group. It is predicted that those people receiving CBT will improve on measures of symptoms,~     and particularly for measures of visual hallucinations.~   "
20992|NCT02782494|"~     In patients receiving long term dialysis, using new generation of QuantiFERON-TB Gold Plus~     can have less result variability in inter-experiment and serial follow up in comparing with~     QuantiFERON-TB Gold In-tube.~   "
20993|NCT02782481|"~     This is a multicenter, randomized, double blind, placebo controlled parallel group clinical~     study. Following a screening period of up to 28 days, eligible subjects will be randomized~     to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous~     subcutaneous infusion of ND0612 or matching placebo for 16 weeks.~   "
20994|NCT02782468|"~     The purpose of this study is to evaluate the safety and tolerability of pevonedistat~     administered as a single agent and in combination with azacitidine in adult east Asian~     participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).~   "
20995|NCT02782455|"~     Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When~     inflamed they become pathological and may present with protrusion and bleeding. A~     randomized, triple blind , controlled study will be conducted to compare the efficacy of~     calcium dobesilate against flavanoids in the management of early haemorrhoidal disease.~   "
20996|NCT02782442|"~     The purpose of this study is to use remote methods and scalable interactive neurotechnology~     to generate important data on the potential for remote targeted cognitive treatment in~     people with schizophrenia. The investigators will perform a double-blind randomized control~     trial in 120 participants with schizophrenia, comparing: 1) An evidence-based structured~     program of 40 hours of on-line auditory and social cognitive training (exercises over 12~     weeks (-3.5 hours per week), delivered with an innovative digital application which provides~     users with a motivation coach to set personalized goals and with secure social networking~     for peer support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ;~     vs.2) A control condition of free-choice on-line cognitive exercises, encouraged at 3.5~     hours per week over 12 weeks, delivered with a standard commercial goal-setting app, Daily~     Goals.~   "
20997|NCT02782429|"~     The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile~     would be able to prevent cognitive disorders in the postoperative period of cardiac surgery,~     since these disorders contribute to an impact on morbidity / mortality in this population.~   "
20998|NCT02782416|"~     Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the~     incidence of active TB~   "
20999|NCT02782403|"~     Objectives:~      Primary:~      Chronic Phase Cohort: To assess the rate of major cytogenetic response (MCyR) of an~     alternating schedule of axitinib and bosutinib in patients with chronic myeloid leukemia,~     chronic phase (CML-CP) after failure of/intolerance to >/= 2 tyrosine kinase inhibitors~     (TKIs) using standard response criteria.~      Advanced Phase Cohort - Phase I Portion: To determine the recommended phase II doses (RPTDs)~     of axitinib and bosutinib in combination in patients with CML in accelerated phase (CML-AP)~     or blast phase (CML-BP).~      Advanced Phase Cohort - Phase II Portion: To evaluate the rate of major hematologic response~     (MaHR) of combined treatment with axitinib and bosutinib in patients with CML-AP or CML-BP~     using standard response criteria.~   "
21000|NCT02782390|"~     Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the~     same tooth. Dental practitioners have shown difficulties related to material's maintenance~     in such type of cavities and therefore, several treatment options have been used. However,~     most of them have shown a great failure percentage. A randomized clinical trial will be~     developed with the objective of assessing the Hall technique in comparison with the~     composite resin incremental technique in 464 primary molars' atypical carious lesions of~     children between 4 and 9 years old. Initially, two previously calibrated examiners will~     perform caries diagnosis by means of visual assessment and intraoral examination. Selected~     teeth will be randomly allocated into two groups. Teeth in the first group will be submitted~     to prefabricated stainless steel crowns treatment (Hall technique); and the other, to~     composite resin incremental technique, which will be always placed under rubber dam~     isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12~     months.~      Treatment's efficacy will be assessed by means of four main outcomes:~        1. Longevity, marginal adaptation, possible modification in patients' vertical dimension,~          and caries lesion progression;~        2. Patient-focused criteria (satisfaction, discomfort and quality of life impact);~        3. cost-efficacy; and~        4. Treatment-related parents', children' and operators' perception.~      Other variables could be further analysed as secondary outcomes, such as techniques~     performing time among operators, impact of the socio-economic characteristics on~     restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons~     between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank~     test. Cox Regression will be used to enable the assessment of other variables' influence in~     the results. Significance value of 5% will be adopted for all analysis.~   "
21001|NCT02782377|"~     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been~     studied in our department over the last 6 years. Sound waves pass into a balloon placed in~     the anal canal and are used to measure the cross-sectional area. By gradually increasing and~     decreasing the pressure in the balloon the investigators can measure the pressure at which~     the cross-sectional area starts to increase and decrease, and the anal canal starts to open~     and close. This assessment mimics the natural opening and closing of the anal canal and the~     effect of squeezing the muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations. In~     previous studies AAR has shown promise in the assessment of faecal incontinence and, that~     unlike manometry, it has been able to distinguish between different types of incontinence.~      The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with~     faeces, fluid or air, whereby there is a change in the pressures within the anal canal to~     determine the type of contents. This can be absent or altered in patients who have~     difficulty in opening their bowels. The RAIR is currently measured by anal manometry using a~     4.9mm catheter, resulting in an anal canal which is already partially opened prior to the~     measurement, and potentially distorted.~      AAR is considered a catheter free technique as the balloon has a cross-sectional area of~     only 0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm~     diameter catheter alongside the AAR balloon to determine the effect that its placement has~     on the recorded parameters of AAR. This aims to improve our understanding of the opening and~     closing of the anal canal in response to distension of the rectum.~   "
21002|NCT02782364|"~     Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department~     over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used~     to measure the cross-sectional area. By gradually increasing and decreasing the pressure in~     the balloon the investigators can measure the pressure at which the cross-sectional area~     starts to increase and decrease, and the anal canal starts to open and close. This~     assessment mimics the natural opening and closing of the anal canal and the effect of~     squeezing the muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations.~     Despite the two measurements being within the normal range, some patients can have~     significant faecal incontinence. This has prompted clinicians to search for a better~     investigation to guide the management of this condition.~      AAR is a reproducible and repeatable technique that has been used as a research technique in~     the assessment of faecal incontinence. It has been shown to correlate with symptom severity~     and, unlike manometry, is able to distinguish between different symptomatic subgroups with~     faceal incontinence. In our studies so far the investigators have increased the bag~     inflation pressure a step at a time which means that each study takes about 20 minutes to~     perform. The limitation of this method is that during the measurement of squeeze pressure~     the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in~     the urethra has demonstrated a faster method of recording measurements over an 8 minute~     period. The investigators propose to study the fatiguability effects of this faster~     technique and validate the method against the existing step-wise technique and standard anal~     manometry.~      Patients will be randomised into two groups:~        1. Stepwise then fast-fill~        2. Fast-fill then stepwise~   "
21003|NCT02782351|"~     The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T~     cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a~     humanized scFv. All participants will receive autologous chimeric antigen receptor~     engineered T cells.~   "
21004|NCT02782338|"~     A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops~     after cataract surgery on INR levels (international normalized ratio) in patients taking~     warfarin.~   "
21005|NCT02782325|"~     Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial~     dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of~     the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in~     which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally~     the trial offers an open label extension period.~   "
21006|NCT02782312|"~     The objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone~     （ICS and LABA）combined inhaled therapy for non-cystic fibrosis（non-CF）bronchiectasis~     patients with chronic airflow obstruction. Moreover, subgroup analysis is performed to~     explore which populations of bronchiectasis patients this treatment is suitable for.~   "
21007|NCT02782299|"~     This is a study to investigate the use of a Decision Aid for shared decision making in older~     adults with distal radius fractures. The goal is to improve patient decisions making, and~     improve patient knowledge through the use of a validated decision aid.~   "
21008|NCT02782286|"~     The study is prospective, double blinded, randomised controlled and has the purpose to~     compare the analgesic effects of ketorolac or morphine intravenous in low back pain.~   "
21009|NCT02782273|"~     The study is prospective, double blinded, randomised controlled and has the purpose to~     compare the analgesic effects of ketorolac or morphine intravenous in renal colic.~   "
21010|NCT02782260|"~     Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active~     cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular~     administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted~     at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy~     of the intervention.~   "
21011|NCT02782247|"~     Chronic viral hepatitis often leads to liver scarring - cirrhosis. If the virus is~     eradicated from the liver, the liver scarring and liver function often recovers. In some~     patients the damage is too severe and recovery does not take place. It is not yet known~     which patients have liver disease that is too advanced to benefit from therapy nor is it~     known how fast the recovery occurs.~      Non-intrusive dynamic liver testing (DLT) may allow us to predict the functionality of the~     liver post treatment and may guide us in treatment choices - for example patients who are~     predicted not to recover may be prioritised for transplantation. Indocyanine green (ICG) is~     a dye solely excreted by the liver into bile and used to measure its dynamic function.~     Transient elastography is similar to ultrasound and measures the degree of fibrosis within~     the liver.~      The investigators hypothesise that the use of non-intrusive dynamic liver testing~     pre-treatment, will allow us to delineate patients before therapy who will have functional~     liver recovery following viral eradication.~      The investigators hypothesise that monitoring changes in liver fibrosis and liver function~     in patients with historical viral clearance will allow an assessment of the likely speed of~     recovery of liver fibrosis and function - for example if all patients 5 years after~     treatment for viral hepatitis induced cirrhosis have 'normal' fibrosis and liver function~     scores the investigators will be able to conclude that recovery is complete within 5 years.~      The investigators will perform a study pre and post-treatment assessing liver function using~     non-intrusive dynamic liver testing in addition to currently-used 'liver function' scoring~     systems, in a multivariate analysis, to determine whether or not the investigators can~     identify patients who are will have functional liver recovery post therapy.~   "
21012|NCT02782234|"~     Contract management is a new management mode.~      To help patients achieve fluid balance through contract management, that is:~        1. edema, congestive heart failure and other similar symptoms begin to reduce to~          disappear;~        2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value~          prescribed by the doctors；~        3. Fluid intake and output keep in balance;~        4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.~   "
21013|NCT02782221|"~     Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing~     effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism,~     and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore~     hypothesize that the fat metabolizing effects of GH depend on abrogation of~     insulin-dependent signaling pathways.~      In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive~     adipose tissue biopsies taken after GH exposure and GH blocking, respectively.~      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as~     in long-sight have great importance for the understanding of growth disorders from~     overweight and type 2 diabetes to malnutrition and eating disorders.~   "
21014|NCT02782208|"~     Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These~     protein anabolic effects require sufficient nutritional supply. During fasting and caloric~     restriction GH predominantly promotes fat metabolism.~      GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose~     uptake in skeletal muscle has been most extensively studied. Substrate competition between~     elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can~     be tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses~     the fat metabolizing effects of GH.~      The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in~     skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.~      In order to investigate this, eight adult hypopituitary patients with documented~     GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively,~     and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.~      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as~     in long-sight have great importance for the understanding of growth disorders from~     overweight and type 2 diabetes to malnutrition and eating disorders.~   "
21015|NCT02782195|"~     Eight adolescent and young adult subjects with type 1 diabetes, age 16−24 years, will be~     recruited for this study on the basis of informed consent. Participants will be invited to~     attend the Wellcome Trust Clinical Research Facility at Addenbrooke's Hospital, Cambridge,~     on two occasions. On each occasion participants will arrive at the unit at 9am having~     controlled their diabetes with short acting insulin for 24 hours and they will remain in the~     unit until 8am the next morning. During the day, between 9am and 6pm participants will~     remain fasting and their blood glucose levels will be controlled by intravenous insulin, the~     dose being determined by 15−30 minute blood glucose estimations. At 1800hr on visit 1 the~     subjects will be asked to ingest an evening meal enriched by a cold isotope glucose tracer~     (non radioactive). The variable insulin infusion will be adjusted to allow for the meal in~     order to achieve good glycaemic control after the meal until 0200hr. From then until 0800hr~     in the morning the study team will again adjust the infusion rates to maintain normal~     glycemia until the participants are ready to go home on their normal insulin regimen. On the~     second visit the protocol will be identical until 1800hr when instead of giving the meal~     variable amounts of glucose will be infused to ensure the glucose levels are identical to~     those observed on visit 1. After 0200hr the study will be effectively finished but the study~     team will continue to vary the insulin infusion to keep blood glucose levels normal until~     the subjects can go home on their normal insulin regime at 8am.~      In order to achieve sufficient information to make all the calculations needed other cold~     isotope glucose tracers will be infused during the study period. These safe non radioactive~     isotope tracers will enable us to assess glucose being produced by the body, its~     distribution and utilization. Throughout both study periods the subjects will be monitored~     very closely by a Clinical Research Fellow, assisted by a Research Nurse, in order to avoid~     any risk of low blood glucose levels.~   "
21016|NCT02782182|"~     The purpose of this study is to see whether it is possible to give 8 doses of a combination~     of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be~     removed with surgery.~   "
21017|NCT02782169|"~     Medical abortion has been associated with significant pain. The objective of this trial is~     to determine whether one dose of pregabalin 300 mg, given during medical abortion in~     addition to the standard of care analgesics, will decrease experienced pain. Investigators~     will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels~     and side effects will be assessed at multiple time points, along with a measure of~     satisfaction.~   "
21018|NCT02782156|"~     In ear, nose, throat (ENT) and jaw surgery departments, up to 60% of patients suffer from~     alcohol dependence (Allen et al., 2009), and may develop an alcohol withdrawal syndrome~     (AWS) when undergoing sur-gery. Caring for these patients creates a major challenge for all~     persons involved: Health care staff is not only challenged by the primary illness but also~     by increased risk of life-threatening complications (infection, bleeding, cardiopulmonary~     dysfunction, impaired wound healing, re-operation), higher mortality rate, and longer~     duration of hospitalization due to preoperative alcohol use and the development of an AWS~     (Delgado-Rodriguez, Gomez-Ortega, Mariscal-Ortiz, Palma-Perez, & Sillero-Arenas, 2003; Eyer~     et al., 2011; Foy, Kay, & Taylor, 1997; Genther & Gourin, 2012; Kuo et al., 2008; Mayo-Smith~     et al., 2004; McCusker, Cole, Abrahamowicz, Primeau, & Belzile, 2002; Neyman, Gourin, &~     Terris, 2005; O'Brien et al., 2007). Moreover, nearly five percent of all patients with an~     AWS develop an alcohol withdrawal delirium (AWD) which, without any therapy, will end~     lethally in 15% of all cases. With adequate medical and other interventions lethality is~     about two percent (Diener, 2003; Wright, Myrick, Henderson, Peters, & Malcolm, 2006).~     Additionally, the occurrence of an AWS and / or AWD represents a threatening, time-intensive~     and complex situation for family members (Repper-DeLisi et al., 2008; Yu et al., 2012).~      Since 2011, in addition to patients undergoing short-term surgery, also patients with~     oncological diagnoses are hospitalized in the ENT and Jaw Surgery Department at the~     University Hospital Basel (USB). These patients are in need of prolonged surgical treatments~     and resulting longer periods of abstinence from food and drink, including alcohol and other~     substances, increase the risk of alcohol withdrawal. For instance, in the ENT and Jaw~     Surgery Department, in 2011, 74 out of 910 inpatients were at risk for or already~     experienced an AWD and 47 of them needed permanent supervision to guarantee their safety.~     Bridging the period of abstinence by drinking alcohol pre- and postoperatively is a~     suboptimal option for these patients due to the relatively long surgical treatment. This~     situation called for action: based on positive experiences within the~     dementia-delirium-programme of USB (Hasemann & Pretto, 2006), an evidence-based approach to~     screen for, detect and treat AWS and / or AWD in ENT and jaw surgery patients was developed~     and implemented (Hasemann, 2013). Now, this new approach needs to be evaluated.~   "
21019|NCT02782143|"~     The proposed Study validates the accuracy of the modified Confusion Assessment Method for~     the Emergency Department~   "
21020|NCT02782130|"~     This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability,~     impact, and long-term sustainability of the Epic Allies intervention application (app), a~     theory-based mobile app that utilizes game mechanics and social networking features to~     improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral~     suppression among HIV-positive young men who have sex with men (YMSM) and trans women who~     have sex with men. Subjects will be randomized to either the intervention branch of the Epic~     Allies app or the control branch of the app.~   "
21021|NCT02782104|"~     The purpose of this study is to assess the safety and tolerability of intranasal esketamine~     in participants with treatment-resistant depression (TRD).~   "
21031|NCT02781974|"~     The study is a parallel-group single blinded randomized controlled trial, examining the~     effect of exercise on physical function in older women with osteoporosis and a history of~     vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the~     intervention group and the control group. The intervention will follow newly developed~     exercise recommendations for people with osteoporosis and vertebral fractures, which states~     the balance- and strength exercises should be performed at least twice a week. The~     intervention is a group exercise session circuit program lasting for 12 weeks. The~     participants will be tested at baseline, and followed up at 3 months and 6 months.~   "
21076|NCT02781285|"~     The researching subject is aimed to obtain the clinical evidences (including real benefits，~     risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by~     compared with the outcomes that not accept the traditional Chinese medicine. the subject~     acquires these clinical practices by using the methods of multicenter、persisting registry~     (the real world researching technology ) and propensity score.~   "
21022|NCT02782091|"~     Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality,~     major social withdrawal and cognitive disturbances. Executive dysfunctions are widely~     considered as primary determinants of functional outcome. However, classic~     neuropsychological executive function measures poorly represent patients' functional outcome~     and seem inappropriate to evaluate the real-world functional impact of the disease.~      In this perspective, Shallice and Burgess have developed for brain-damaged patients, the~     Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and~     mental flexibility in real life settings, thus better capturing day-to-day abilities and~     including contextual (social, perceptive) influences. Setting the assessment outside the~     laboratory can help to identify subtle executive impairment not systematically expressed in~     standard care conditions and consequently improve the future care solutions. MET is based on~     the Supervisory Attentional System (SAS) model of executive functioning and attention~     control that specifies how thought and action schema become activated or suppressed for~     routine and non-routine circumstances .~      MET has been designed to measure real-world executive performance confronting the~     participants to unpredictable affordances and interpersonal interactions while planning and~     problem solving. Patients are asked to accomplish several tasks of variable complexity in an~     unknown commercial district. A number of rules must be respected and thus an action plan,~     strategy formulation, time and space management with very little assistance of the examiner~     are required.~      Most of the studies involving MET were conceived for patients with acquired brain damage.~     LeThiec offered an extensive protocol with the initial scoring system (in terms of~     inefficiencies, rule breaks, interpretation failures and task execution failures).~     Simplified versions of MET were also suggested to be more suitable in hospital settings.~     Only one study was done in SZ including a single patient, it is therefore difficult to draw~     conclusions about clinical utility in SZ. To date, no other studies investigated the~     suitability of MET in patients with psychosis, while executive impairment is well documented~     in this population The investigators hypothesized that the Multiple Errands Test (MET), an~     ecological assessment of executive function has a better ability to measure everyday~     adaptative functioning SZ, compared to conventional EF assessment methods.~      The objectives of this study are: (1) establish normative data and (2) study discriminant~     validity of this tool with a large panel of EF measures.~   "
21023|NCT02782078|"~     Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA~     guidelines) but some interaction is observed. The objective of this study is to evaluate and~     quantify rifampicin interaction on clindamycin~   "
21024|NCT02782065|"~     The purpose of this research will be to evaluate the reliability and validity of the HASS~     tool in a cohort of patients' ages 7 to18 years old against the gold standard of spirometry,~     and in ages 2 to 6 against spirometry, if possible, and the most similar validated tool, the~     PRAM.~   "
21025|NCT02782052|"~     Activity-related dyspnoea appears to be the earliest and the most frequent complaint for~     which patients with PAH seek medical attention. This symptom progresses relentlessly with~     time leading invariably to avoidance of activity with consequent skeletal muscle~     deconditioning and an impoverished quality of life. Unfortunately, effective management of~     this disabling symptom awaits a better understanding of its underlying physiology. Our team~     has recently showed that PAH patients may exhibit reduced expiratory flows at low lung~     volumes at spirometry (namely instantaneous forced expiratory flows measured after 50% and~     75% of the FVC has been exhaled [FEF50% and FEF75%] lower than predicted), despite a~     preserved forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) .~     Several studies have shown that such a finding (small airway disease) could be common in~     certain PAH cohorts, have either related it to incidental descriptions of airway wall~     thickening with lymphocytic infiltration in PAH or proposed several other speculative~     explanatory mechanisms, either biological or mechanical. Whatever its cause, reduced~     expiratory flows at low lung volumes imply that the operating tidal volume (VT) range~     becomes closer than normally to residual volume (RV) mostly through an increase in RV~     (elevated residual volume/total lung capacity ratio, RV/TLC). The reduced difference between~     forced and tidal expiratory flows promotes dynamic lung hyperinflation [i.e., a progressive~     increase in end-expiratory lung volume (EELV)] under conditions of increased ventilatory~     demand. Dynamic lung hyperinflation (DH) is well known to have serious sensory consequences,~     i.e., increase in dyspnoea intensity, as clearly shown in patients with chronic obstructive~     pulmonary disease and chronic heart failure. The aim of this study is to evaluate whether~     administration of inhaled BDs (β2-agonist and/or anticholinergic), as add-ons to~     vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of~     onset of DH, thus ameliorating the exertional symptoms in patients with stable PAH~     undergoing high-intensity constant work-rate (CWR) cycle endurance test.~      This is a randomised double-blind placebo-controlled crossover study. Design: 5 visits; V1:~     screening, familiarization, incremental cardiopulmonary exercise testing (CPET); V2:~     constant work-rate (CWR-CPET); V3, V4 and V5: CWR-CPET after intervention, in a random~     order: Placebo (P), Ipratropium Bromide (IB), Ipratropium Bromide + Salbutamol (IB+SALB).~   "
21026|NCT02782039|"~     The purpose of that register is to collect medical information about patients suffering of~     APS with or without associated SLE.~   "
21027|NCT02782026|"~     In this prospective case-control study, the investigators will evaluate the diagnostic~     performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial~     Hypertension (PAH). This study is designed to:~        1. Assess the performance of the E-nose to discriminate controls from patients with PAH~        2. Assess the performance of the E-nose to discriminate between different subtypes of~          pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation~          and chronic thromboembolic PH~        3. Assess the performance of the E-nose to discriminate controls from asymptomatic~          patients with PH who carry BMPR2 mutations.~   "
21028|NCT02782013|"~     Pneumonia is a common infectious disease of the lung, often requiring treatment in the~     hospital. Clinical scoring systems are available, identifying patients not requiring~     hospitalization. However, the course of disease of patients in the hospital remains hard to~     predict. While most patients will recover quickly, some will, despite appropriate treatment,~     develop a severe course leading to sepsis and systemic responses resulting in organ~     dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular~     markers and combinations thereof predicting a severe course of pneumonia in the hospital.~     Such predictors will, for instance, support decisions on earlier transfer of patients to~     intensive care and thus improving outcome.~   "
21029|NCT02782000|"~     With the number of aged people increasing and the lifespan lengthen, dementia is becoming a~     great public challenge in China. Early recognition of dementia is crucial to improve the~     prognosis of dementia patients and decrease the society disease burden. It is a pity that~     the early recognition rate of dementia is less than 7% in China. Most of the aged people~     live in the community and general practitioners (GP) in community provide health service~     much more frequently than other medical workers. It is suggested that GPs should be the best~     one to screen dementia in its early period. However, most of GPs have not receive any~     training about dementia early recognition in China. It is imperative and meaningful to~     provide training to GPs for improve GPs' knowledge and skills about dementia early~     recognition. How to train GPs for early recognizing dementia and how about the training~     effect? Which training model may be better? We did not find consistent conclusion about~     these questions in China. This study aims to set up an effective and convenient model to~     training GPs in dementia early recognition. A total of 152 GPs in Beijing will be enrolled~     and be randomly divided into two groups. One group will firstly have lessons about dementia~     early recognition and then receive face-to-face supervision and key messages by Wechat about~     dementia early recognition once a month in the following 6 months. Another group will~     firstly have lessons about dementia early recognition and then receive face-to-face~     supervision and key messages by Wechat about dementia early recognition once a month in the~     following 3 months. The score of knowledge and attitude about dementia early recognition,~     the accuracy of analyzing dementia cases, the usage of dementia screening scales and the~     referral rate of dementia will be evaluated at different time point respectively. This study~     will provide evidence for training GPs effectively in dementia early recognition in the~     future and will promote dementia early recognition in community.~   "
21030|NCT02781987|"~     The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in~     chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether~     CP patients in early clinical stage have a higher PEP incidence, and to identify the~     predictive and protective factors for PEP in chronic pancreatitis patients.~   "
21032|NCT02781961|"~     Previous studies have shown that histological changes in the gastric mucosa between obese~     and non-obese individuals do exist. Understanding these histological differences (between~     obese and non-obese individuals) might elucidate obesity pathophysiology.~      However, the data is scarce and even contradictory. Even less is known about the~     histological characteristics of the duodenal mucosa in obesity and lean states, but several~     studies already performed hint for some differences. These differences might influence gut~     hormones composition and function and play a crucial role in the development of obesity and~     metabolic syndrome. To our best knowledge, in-vivo, human, real-time cellular level~     comparison of gastric and duodenal mucosa has never been done. This can be now accomplished~     with pCLE.~      pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This~     optic fiber is then inserted through the working channel of a standard endoscope, bringing~     the microscope at the tip of the fiber to close proximity with the tissue. The system~     applies a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein,~     once) provides a cellular-level, in-vivo, real time images: the concept of so called~     optical biopsies. The system has been used as an auxiliary tool in GI-endoscopy in recent~     years. This technology has been shown to be useful in identifying objective histological~     features and even intramucosal bacteria in different tissues.~   "
21033|NCT02781948|"~     Evaluate the repeatability and reproducibility of iVue for measuring the total corneal~     thickness, the epithelial thickness, and the stromal thickness in normal subjects and~     patients with various corneal conditions.~   "
21034|NCT02781935|"~     The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination~     with other imaging modalities (multiparametric MRI and CT Scan) in determining the true~     status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for~     unresectable or borderline resectable colorectal liver metastasis (CRLM).~   "
21035|NCT02781922|"~     The purpose of this study is to evaluate the efficacy and safety of intracoronary injection~     of JRM-001 after reconstructive surgery in pediatric patients with functional single~     ventricle~   "
21036|NCT02781909|"~     Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the~     duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed~     therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS)~     could be useful in this context, and therefore its the appropriateness and potential effect~     of this approach needs to be evaluated in humans. Investigators do propose a prospective,~     randomized, pilot study to estimate the potential efficacy and safety of using adjunctive~     ibuprofen for the treatment of XDR tuberculosis.~   "
21037|NCT02781896|"~     The purpose of this study is to determine whether a left ventricular rapid pacing using the~     valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the~     overall procedure duration in comparison with the conventional method.~   "
21038|NCT02781883|"~     The primary objective of this study is to assess whether the combination of BP1001 and LDAC~     provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete~     hematologic recovery [CRi], Complete Remission with incomplete platelet recovery [CRp]) than~     LDAC alone (by historical comparison) in participants with AML that cannot or elect not to~     be treated with more intensive chemotherapy. Safety, pharmacokinetics, overall survival,~     time to response, and duration of response will also be studied.~   "
21039|NCT02781766|"~     Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to~     maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds~     and other serious bleeding events, prophylactic factor replacement therapy is used. Because~     of the high cost and limited availability of clotting factor concentrates, dosing is a~     crucial issue for prophylaxis therapy. Several studies reported a better correlation between~     clinical bleeding tendency of patients with haemophilia and thrombin generation assay~     results compared to FVIII/FIX levels. However there is no specific data showing that~     thrombin generation may be a better indicator of the clinical efficacy of prophylaxis~     compared to the conventional FVIII measurement.~      The main objective of this open, multicentre, prospective study is to compare trough~     thrombin generation capacity and FVIII levels in severe haemophilia patients and compare~     these two laboratory results with:~        -  the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred~          in the last 6 months~        -  the number of additional FVIII units used in the last 6 months~      This project requires no change in term of type of treatment : During the study, each~     patient will be treated by his usual clotting factor at the usual regimen (frequency and~     dosage).~      The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results~   "
21040|NCT02781753|"~     The purpose of this study is to evaluate the dosages of recombinant human serum~     albumin/interferon alpha2b fusion protein injection in healthy subjects.~   "
21041|NCT02781740|"~     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The~     most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy~     has been shown to significantly reduce subjective sleepiness and blood pressure in patients~     with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly~     held view is that CPAP should be used for at least 4h/night. However, previous studies have~     estimated that a considerable proportion of CPAP users fail to achieve this. In addition,~     there is inadequate evidence to support this apparent threshold effect and so it is unclear~     whether such patients actually benefit from treatment or whether they could be withdrawn~     from CPAP, thus substantially reducing health care costs, or encouraged to increase their~     nightly usage of CPAP.~      The aim of the proposed project is to study the effect of CPAP withdrawal on subjective~     sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that~     two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of~     OSA-related symptoms. This trial will better establish the minimum level of CPAP adherence~     which could generally be regarded as effective in reducing OSA-related symptoms.~   "
21042|NCT02781727|"~     A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth~     hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be~     given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females)~     with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH :~     Genotropin). This is a global trial that will be conducted in, but not limited to, the~     United States, Canada, Germany, France, Poland, Bulgaria, Russia and Australia.~   "
21043|NCT02781714|"~     Meeting women's need for postpartum family planning is has been acknowledged as a global~     priority in maternal and child health. The prevention of unintended pregnancies in~     sub-Saharan African countries, which carry the highest global burdens of maternal mortality~     and HIV infection, is projected to substantially decrease maternal and neonatal morbidity~     and mortality. Many barriers to contraceptive uptake exist, both within and outside of the~     postpartum time period, and include socio-cultural, economic, and supply-side factors.~     Furthermore, while the importance of engaging men in family planning programs has been~     acknowledged for decades, few interventions have succeeded in increasing male involvement in~     family planning while maintaining a focus on women's empowerment. Innovative approaches to~     meeting the family planning needs of women and couples are urgently needed.~      Public health interventions are increasingly incorporating mobile health (mHealth)~     approaches using short message service (SMS) technology in low-income countries, approaches~     that have demonstrated benefit among various reproductive health outcomes. The investigators~     hypothesize that personalized, bidirectional SMS dialogue with individual women and couples~     will increase postpartum contraceptive uptake, thereby decreasing unmet need for family~     planning in Kenya. The investigators have collaborated with the University of Washington~     (UW) Department of Computer Science and Engineering (CSE) along with Kenyan~     telecommunication providers to develop a hybrid messaging system that allows for innovative~     bidirectional SMS messaging. This system has been used successfully in maternal child health~     (MCH) clinics in Kenya. In qualitative research, women in Kenya have expressed a strong~     desire for mHealth support to provide additional education, counseling and reminders to~     supplement counseling by health workers.~      The investigators propose a randomized controlled trial (RCT) comparing the effects of~     bidirectional SMS dialogue vs. control on highly effective contraceptive use at 6 months~     postpartum among HIV negative women and couples in Nyanza Province, Kenya. Data from this~     RCT and accompanying qualitative study will contribute to innovative, scale-able strategies~     to address unmet need for contraception and increase male involvement in family planning.~   "
21044|NCT02781701|"~     From Weill Cornell Medical College Center for Sleep Medicine, the investigators will recruit~     patients (N = 25) with previously documented moderate to severe OSA. They will receive an~     all-night in-home sleep study to document the severity of their OSA immediately before~     starting the training regimen. Scales and questionnaires measuring sleepiness, snoring,~     fatigue, and insomnia will be administered prior to starting the training and repeated after~     six weeks of training. Subjects may be removed from the study due to failing to adhere to~     the training regimen at anytime via remote data monitoring. The principal measure of the~     efficacy of the treatment will be the change in RDI, the number of abnormal breathing events~     per hour of sleep.~   "
21045|NCT02781688|"~     Pilot study to assess a multi-component intervention to increase physical activity in~     persons with depression.~   "
21046|NCT02781675|"~     A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including~     nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin~     olive oil as the main source of fat has been associated with reduced risk of cardiovascular~     disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines~     Advisory Committee. The strongest experimental support for this recommendation derives from~     the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a~     Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular~     disease risk in comparison to either low-fat or Western dietary patterns. However, in none~     of these studies were comparisons made between the effects of Mediterranean-style diets with~     low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to~     determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a~     Mediterranean dietary pattern based on that used in the PREDIMED study results in similar~     improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a~     standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2)~     modification of the Mediterranean diet by replacing low-fat dairy products with high-fat~     dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase~     LDL-C and apoB but may raise large buoyant LDL particles compared with a standard~     Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result~     in comparable reductions in levels of inflammatory markers and oxidized LDL, and~     improvements in endothelial function compared to a Western diet.~   "
21047|NCT02781662|"~     This study evaluates an intervention to reduce medication errors and adverse drug events in~     older adults who have recently been discharged from the hospital and prescribed~     anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the~     intervention, while the other half will receive usual care.~   "
21048|NCT02781649|"~     In this study, individuals without hepatitis C infection who are on the kidney transplant~     waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be~     treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100~     mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant~     procedure and continued for 12 weeks post-renal transplant.~   "
21049|NCT02781636|"~     30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out~     to 90 days.~   "
21050|NCT02781623|"~     This study will quantify and examine the extent to which the quadriceps femoris muscle group~     atrophies following tibial plateau fractures and the length of time that atrophy affects~     function. The study will also look at the effects of tibial plateau fractures on the~     quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy~     will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post~     operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be~     scanned in order for the non-injured leg to serve as the control. In this way muscle volume~     can be estimated from the muscle thickness at specific locations in the thigh. The muscle~     strength of the quadriceps will also be assessed at the 3 month and 1 year visit by~     measuring isokinetic knee-extension torque, and functional assessment questionnaires will be~     completed at each study visit.~   "
21051|NCT02781610|"~     Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during~     which symptoms of lung infection increase and lung function decreases. These pulmonary~     exacerbations are treated with varying antibiotics for varying time periods based on needs~     determined by individual patients, their families, and the health care providers. Cystic~     fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the~     Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also~     identified key questions for which additional studies were needed.~      A strong desire among clinicians to reduce treatment durations (and reduce cost,~     inconvenience, and potential toxicities) is in conflict with belief that patients not~     responding robustly to treatment might benefit from extending treatment.~      This randomized, controlled, open-label study is designed to evaluate the efficacy and~     safety of differing durations of IV treatment, given in the hospital or at home for a~     pulmonary exacerbation in adult patients with CF.~   "
21056|NCT02781545|"~     Infants requiring surgery in the neonatal period for complex congenital heart diseases are~     at risk for developmental problems. For infants with congenital heart diseases with~     admixture physiology and single ventricles, optimal circulation is associated with signs of~     adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75%~     to 90%. Infants are often unable to withstand standardized developmental testing during~     early infancy due to medical fragility and sternal precautions after surgery. Evaluation of~     the quality of spontaneous movements and movement variability is a good alternative. The~     quality of general movements in early infancy is a valid predictor of neurological disorders~     in high risk infant groups and is assessed with short periods of video-recorded~     observations. This methodology has yet to be studied in infants with complex congenital~     heart disease that require surgery as neonates. For older infants, the Infant Motor Profile~     (IMP) is a promising tool to document developmental outcome.~   "
21057|NCT02781532|"~     The main objective of our study is to determine if the evaluation of ingesta of cancer~     patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of~     patients during hospitalization (for patients malnourished, at risk of malnutrition or risk~     free).~   "
21058|NCT02781519|"~     The purpose of the study is to characterize the acute effects of cannabinoids in women~     relative to men and to begin probing the mechanisms that may underlie gender differences.~   "
21059|NCT02781506|"~     Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or~     unacceptable toxicity; SABR, dose variable, in 1-3 fractions.~   "
21060|NCT02781493|"~     Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing~     quality before colonoscopy.~   "
21061|NCT02781480|"~     The inherited retinal dystrophies are a clinically and genetically heterogeneous group of~     conditions, which often present in childhood.Inherited retinal degenerations cause sight~     impairment in approximately 1 in 3000 people in the Western world. There are currently no~     effective treatments.~      Leber congenital amaurosis (LCA) is a severe, early-onset form of inherited retinal~     degeneration involving both rod and cone photoreceptors. LCA is caused by mutations in one~     of at least 19 different genes.Mutations in RPE65, which is expressed in the retinal pigment~     epithelium (RPE), are responsible in 3 to 16 % of people affected. The RPE65 gene encodes a~     65-kDa retinal pigment epithelium (RPE)-specific protein that is required for the conversion~     of vitamin A to 11-cis-retinal by the RPE and is essential for the regeneration of the rod~     visual pigment~      Proof of principle studies for RPE65 gene replacement therapy has been demonstrated with the~     use of recombinant adeno-associated virus serotype 2 (rAAV2/2) vectors in animal models.~     Furthermore clinical trials of gene replacement therapy in RPE65 associated LCA (RPE65-LCA)~     have shown significant promise. All three clinical trials showed improvement in visual~     function over the first year, however longer term follow up Proof of principle studies for~     RPE65 gene replacement therapy has been demonstrated with the use of recombinant~     adeno-associated virus serotype 2 (rAAV2/2) vectors in animal models. Furthermore clinical~     trials of gene replacement therapy in RPE65 associated LCA (RPE65-LCA) have shown~     significant promise. All three clinical trials showed improvement in visual function over~     the first year, however longer term follow up demonstrated progressive visual loss and that~     initial improvements were not maintained.~      Greater efficacy was noted in animal models. The relatively lower efficacy of treatment in~     participants was most likely due to insufficient production of RPE65 protein from AAV2/2~     hRPE65 in the human eye.~      Having identified the maximal tolerated AAV2/2 vector dose in the previous clinical trial,~     an optimized therapeutic vector to drive more efficient transgene expression and increase~     the availability of RPE65 for affected humans has been developed.~      The aim of this trial is to determine the safety of the new optimised AAV2/5 vector in~     humans and to explore its potential efficacy.~   "
21062|NCT02781467|"~     This study will find the highest acceptable treatment dose of cord blood, culture expanded~     natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or~     refractory acute myeloid leukemia.~      The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to~     help the NK cells expand in the body. The safety of this treatment will be studied and~     researchers want to learn if NK cells will help in treating the AML.~   "
21063|NCT02781454|"~     The purpose of this research study is to find out whether the drug mexiletine will be~     effective in lowering motor neuron electrical activity in the brains and nerves in the arms~     of people with ALS. The investigators will also determine if there are any signs that the~     drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching.~     This will be determined through transcranial magnetic stimulation (TMS) and threshold~     tracking nerve conduction studies (TTNCS). In this trial, the participants will be taking~     either 300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).~   "
21064|NCT02781441|"~     MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over~     75 years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000~     person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by~     leukemic transformation. The disease is heterogeneous, its pathophysiology complex and~     clinical evolution variable.The few data available on MDS patients show how difficult it is~     to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In~     the context of a highly complex potentially lethal disease such as MDS, it is of utmost~     importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS~     patients surveyed in our developmental study would have preferred more information about~     prognosis at diagnosis disclosure.~      A simple intervention based on the use of a question prompt list (QPL), would greatly~     improve the information process by helping patients to express their main concerns at their~     medical consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have~     not yet been widely used in France.~      However, in line with the previous results available in the literature and in a context a~     priori favourable to the use of such an instrument, the investigators hypothesise that use~     of a QPL will increase MDS patients' expressions of concerns and questions at their medical~     consultations. Particularly the investigators assume that the discussion about prognosis~     will be facilitated, without increasing anxiety because patients remain free to ask or not~     for such information. The use of QPLs would also be a way to limit social inequalities~     related to insufficient information and to encourage patient-doctor communication and~     meeting of patient preferences which could lead to better health outcomes.~   "
21124|NCT02780661|"~     This method development study will be a two treatment arm, randomized, cross over study in a~     population with edentulous upper arch restored with a maxillary complete denture. The lower~     may be a partial or full edentulous mandibular arch that may be restored with a stable~     complete, partial or implant supported denture.~   "
21142|NCT02780427|"~     The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus~     have not been described for sedation in children undergoing transthoracic echocardiography~     (TEE) study. This information is important to compare agents and to determine the most~     effective sedative dose. The investigators performed a two-stage study to determine the ED50~     and the ED95 of intranasal dexmedetomidine to investigate age-related differences in~     participants undergoing transthoracic echocardiography study.~   "
21065|NCT02781428|"~     This is a prospective multicentre observational study to assess the sensitivity of the~     UroMark assay to detect bladder cancer in participants with new or recurrent disease. The~     study will recruit patients with newly detected or recurrent bladder cancer. The reference~     standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade~     1, 2 or 3 diseases with or without CIS, or CIS alone.~      Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached~     and asked to consent for this study. Consenting participants will be provided with a urine~     sample collection kit and asked to provide a urine sample. Samples can be provided at home~     and posted to the receiving lab using the stamped addressed envelope. The urine sample must~     be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance~     cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.~      The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study~     requiring provision of a urine sample, it will be possible for patients in DETECT II to be~     recruited to other trials.~   "
21066|NCT02781415|"~     The aim of this study is to compare the clinical efficacy and safety profiles of a 30~     minutes acupuncture session performed at an ER of a tertiary hospital versus titrated~     intravenous morphine in the management of acute severe pain syndromes (defined as a visual~     analogue scale (VAS) score >/= 70) taking for example acute renal colic.~   "
21067|NCT02781402|"~     World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in~     kilograms to the square of the height in meters (kg/m2). BMI has been used widely to~     diagnose obesity as it is a simple method to be carried out and is also inexpensive.~     According to WHO, there were 1.9 billion overweight individuals in 2014 with the age of 18~     years old or above. Of 1.9 billion overweight individuals, there were 600 million obese~     adults. The prevalence of cardiovascular disease is higher among the overweight and obese~     individuals compared to individuals with normal body mass index. This probably is due to~     altered cardiovascular autonomic regulation. The risk of getting cardiovascular diseases is~     also higher among physically inactive individuals. As much as 60% of American adults are not~     regularly active and 25% of them are not active at all. Obese and overweight individuals~     tend to be physically inactive and it has been shown that there is a negative relationship~     between BMI and heart rate recovery (HRR). HRR is defined as difference in heart rate~     between maximum exercise and 1 minute later during recovery period after stopping of~     exercise. HRR after exercise stress is due to withdrawal of sympathetic nervous system and~     the reactivation of parasympathetic nervous system. Parasympathetic nervous system is~     altered in obese individuals therefore leading to poor HRR after exercise. Aerobic training~     not only can reduce the body composition but also improves the autonomic cardiovascular~     control. There is limited literature support for any study which shows that potential of 4~     weeks aerobic training can influence the heart rate recovery in sedentary healthy adults.~     Most of studies conducted were using minimum of 6 to 8 weeks of aerobic training. The~     potential of 4 weeks of aerobic training in improving the autonomic nervous system among~     sedentary adults is still unclear. Therefore, we hypothesized in our study that there will~     be effect of 4 weeks of aerobic training on vagal modulation.~   "
21068|NCT02781389|"~     The aim of this non-interventional study is to provide further data on the utilization,~     effectiveness, safety and clinical benefit including duration of response of Vismodegib for~     treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or~     radiotherapy and metastatic basal cell carcinoma (mBCC) under real world clinical~     conditions.~   "
21069|NCT02781376|"~     Obstructive Sleep Apnea (OSA) is prevalent in children and adolescents and associated with a~     variety of negative consequences affecting health and cognitive functioning. While clinical~     guidelines outline effective strategies for the diagnosis and management of pediatric OSA,~     rates of screening, identification, and management in primary care settings remain low. The~     aim of the current study is to evaluate the use of a computer decision support system module~     (CHICA-OSA) designed to improve adherence to OSA guidelines in pediatric primary care~     clinics. All children ages 1-11 years will be screened for snoring and other symptoms of OSA~     in the waiting room prior to a visit to their primary care provider (PCP). In clinics~     randomly assigned to CHICA-OSA, caregivers of snoring children will report on additional OSA~     symptoms, and PCPs will receive automated prompts in the electronic health record (EHR) to~     provide evidence-based evaluation and appropriate referral for testing. For children sent~     for polysomnography (PSG), PCPs will receive automated prompts to reassess symptoms at the~     next visit. We hypothesize that clinics using CHICA-OSA will have better adherence to~     guidelines, as evidenced by higher rates of identifying OSAS, referral for PSG, and~     re-assessment following treatment.~   "
21070|NCT02781363|"~     The Thoracic ultrasound is a safer and sensitive technique than conventional radiography~     because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions.~     The main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled~     personnel in the emergency service prdiatricas to diagnose pneumonia in children.~   "
21071|NCT02781350|"~     The main objective of this research is to investigate the effect of addition of fiber on the~     high fat high carbohydrate (HFHC) meal induced inflammation and oxidative stress mechanisms~     at the molecular level in humans, in vivo. The investigators have previously shown that the~     intake of one HFHC meal leads to an increase in oxidative stress and inflammation. HFHC meal~     also induces an increase in the expression of suppressor of cytokine signaling- 3 (SOCS-3)~     in the mononuclear cells (MNC), which interferes with insulin signal transduction and~     contributes to the pathogenesis of insulin resistance. In contrast, an American heart~     association (AHA) meal rich in fruits and fiber does not induce these effects. These~     observations are important since HFHC meal not only induces oxidative stress and~     inflammation but also lays the foundations of a potentially greater insulin resistance~     through the induction of SOCS-3, TLR-4 and TLR-2.~   "
21072|NCT02781337|"~     This is a Registry that invites patients undergoing colorectal surgery for colorectal~     cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood~     banks for analyzing different genetic mutations and disease-specific biomarkers.~   "
21073|NCT02781324|"~     The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic~     bone scalpel (or osteotome device) with standard of care surgical instruments during~     posterior spine fusion with instrumentation.~   "
21074|NCT02781311|"~     This study will evaluate the safety, tolerability and efficacy of the oral administration of~     setipiprant tablets 1000 mg twice daily (BID) relative to placebo and active comparator,~     finasteride 1 mg once daily, in 18 to 41 years old males with androgenetic alopecia (AGA).~   "
21075|NCT02781298|"~     This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic~     effect in infants.~   "
21433|NCT02776631|"~     A prospective randomized study comparing a new implant with three interlocked pins for~     internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping,~     Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).~   "
21077|NCT02781272|"~     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system~     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood~     based on cellular size and deformability. In a small pilot study, scientists at the Medical~     University of Vienna demonstrated that measurement of a combination of mRNA markers~     extracted from CTCs captured using the Parsortix system could be used to identify women with~     ovarian cancer. This study is designed to provide specimens for optimization of an assay~     using clinical and biomarker information (i.e. demographics, imaging results and/or serum~     tumor markers) in combination with mRNA extracted from rare cells in the blood of women~     presenting with a pelvic mass for the detection of malignancy.~      Primary Objective: Optimization of an assay/algorithm for the differentiation of women with~     benign pelvic masses from those with malignant pelvic masses using clinical and biomarker~     information (i.e. demographics, imaging results and/or serum tumor markers) in combination~     with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum~     protein markers and mRNA markers will be measured, and the results will be compared to the~     actual clinical diagnosis made for each subject through other recognized methods (i.e.~     histopathology). Statistical modeling will be used to combine the clinical information,~     serum protein markers and/or mRNA markers for estimation of the risk of malignancy. If~     successful, the resulting risk algorithm will be evaluated in future, appropriately powered,~     prospective studies.~      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary~     design of a mathematical algorithm to combine the clinical information, serum protein~     markers and/or mRNA markers for estimation of the risk of malignancy.~   "
21078|NCT02781259|"~     In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine~     green was performed during axillary lymph node dissection in breast surgery . By comparing~     the concordance between the passage of indocyanine green and actual lymph node metastasis,~     selective lymph node dissection can be developed.~   "
21079|NCT02781246|"~     Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural~     dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric~     patients has not been investigated. This study was designed to determine the effect of~     perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients~   "
21080|NCT02781233|"~     This study evaluates the clinical impact of a progressive resistance training program in~     adults patients with haemophilia~   "
21081|NCT02781220|"~     The main purpose of this study is to build upon the evidence captured in the Imaging~     Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable~     information regarding patient-reported outcomes and physician confidence in diagnosis and~     management based on the Implications for Management of PET Amyloid Classification Technology~     (IMPACT; NCT number not yet assigned) trial design.~   "
21082|NCT02781207|"~     This is a observational prospective study. For patients presenting to the Emergency~     Department with loss of consciousness, emergency physicians will be asked to screen the real~     syncope without an evident and immediate cause for the loss of consciousness (e.g.~     vasovagal) and/or at least one high risk condition as listed by the European Society of~     Cardiology in the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe~     structural or coronary artery disease, clinical or ECG features suggesting arrhythmic~     syncope, and important co-morbidities).~      In case of a real syncope not clearly physiopathologically explained and no high risk~     conditions, the emergency physician in charge will check risk factors for high risk syncope~     and categorize again every cases.~      A high risk syncope is characterized by at least one high-risk characteristic (based on 2015~     Syncope clinical management in the emergency department consensus): syncope during~     exertion, in supine position, with new onset of chest discomfort, palpitations before the~     loss of consciousness, family history of sudden death, congestive heart failure, aortic~     stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic~     cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection~     fraction <35%, previously documented ventricular arrhythmia, coronary artery disease,~     congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous~     ICD implantation, anemia (i.e. Hb <9 g/dl), lowest systolic blood pressure in the ED <90~     mmHg, sinus bradycardia (<40 bpm), new (or previously unknown) left bundle branch block,~     bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent~     with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (>450~     ms).~      Low and intermediate risk syncopes will be enrolled and evaluated using an integrated~     point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and~     lung, focus cardiac and venous compression ultrasonography).~      After discharge, the risk of patient's syncope will be determined by reviewing the entire~     medical records.~   "
21083|NCT02781194|"~     The aim of this investigation is to assess the impact of forced air warming, warm humidified~     insufflation gas and the combination of the two on intraoperative temperature maintenance~     and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid~     following laparoscopic procedures (duration > 60 min) in a prospective, randomized,~     controlled, double-blinded mono-centric study. Therefore 150 subjects will be randomized in~     3 groups of 50 subjects each. First group will be treated with forced-air warming blanket~     (bair hugger). Second group will be treated with warmed, humidified insufflation via the F&P~     HumiGard™ Surgical Humidification System. Third group will be treated with both, warming~     blankets and warmed, humidified insufflation. The peri-operative temperature of patients~     might be higher in patients of the third group with the combination of both treatments. The~     investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD~     usage will differ between groups. Wound infection incidence and time spent in PACU are also~     expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher~     in patients undergoing laparoscopic procedures with humidified gas insufflation, since the~     trauma to the peritoneum will be less.~   "
21084|NCT02781181|"~     A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device~     (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving~     noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of~     CPDs are still a matter of controversy. It has been argued that the limited reduction~     provided by CPDs may be due to the devices themselves. Probably, they serve as sources for~     emboli during the procedure or removal technique. In general, 30- day adverse outcome for~     CAS with the use of CPDs seems not to be different from the outcome without CPDs.~      Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as~     safe as in those patients who undergo CAS with CPD neuroprotection.~   "
21085|NCT02781168|"~     The aim of this study was to investigate the influence of the use of headphones in salivary~     cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness~     and handling NB, measure the concentrations of salivary cortisol before (baseline) and after~     the use of hearing protection (response) in the neonatal intensive care unit (NICU).~      A NICU nap periods and compare the influence of the use and non-use of hearing protection in~     salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.~   "
21086|NCT02781155|"~     This study investigates whether it is feasible to teach cancer patients undergoing~     chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects.~     Moxibustion is a therapy used in traditional Chinese medicine that uses heat.~   "
21446|NCT02776462|"~     The purpose of this study is to determine the sensitivity and specificity of an aid in~     assessment of concussion based on eye-tracking, in comparison to a clinical reference~     standard appropriate for the Emergency Department (ED).~   "
21087|NCT02781142|"~     Motor imagery training facilitates the neural plasticity with increasing the neuronal~     cortical pathways in the brain. Motor imagery training is an effective way in stroke~     survivors. However, its effects in persons with multiple sclerosis (MS) are not known.~     Additionally, telerehabilitation based motor imagery training is very rare treatment way~     which requires more research. Therefore, this study aims to investigate the effect of~     telerehabilitation based motor imagery training on gait and balance performance of the~     persons with MS.~      The participants will be allocated into three groups, including motor imagery training,~     wait-list control group, and age, gender, and education matched healthy control group. Each~     group will include at least 25 participants (i.e. in total 75 participants).~      All the assessments will be performed before and after the training in the 6-week motor~     imagery training group. The participants in the wait-list control group will underwent the~     assessment with a 6-week interval. The healthy participants will be assessed only one.~      The motor imagery training will be designed for the individual basis with following standard~     protocols. It will be applied three times a week for 6 weeks. The first three sessions will~     be performed in the clinic, the other will be performed at the patients' home with a~     telerehabilitation technique.~   "
21088|NCT02781129|"~     This study is designed to identify brain activity associated with good memory in subjects~     with a chronically implanted RNS® device and to study the effects of therapeutic stimulation~     for epilepsy on memory. This will be accomplished through analysis of ECoG data collected~     during memory encoding for short and long-term free recall as well as during navigation~     tasks.~   "
21089|NCT02781116|"~     This study will have great impact and influence in the medical setting as the targeted model~     that will be derived from this study will be the pioneer in our region. This model will be~     beneficial in identifying risk factors and its association with the Arab women population.~     Furthermore, it will bring chemotherapy prevention once the risk factors and the model are~     established. Risk factors maybe different from those identified in western women by Gail and~     IBIS Models~   "
21090|NCT02781103|"~     This is a single blind, randomized controlled pilot trial of transcranial direct stimulation~     (tDCS) intervention or tDCS sham administered with a standardized guided imagery~     intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized~     (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of~     the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of~     the study will receive guided imagery with sham tDCS. Subjects will remain blinded until the~     end of the study.~   "
21091|NCT02781090|"~     This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking~     cessation program + social network for HIV-infected smokers) to the American Heart~     Association Getting Healthy website in promoting abstinence in a group of HIV-infected~     smokers. All participants will be offered a three-month supply of nicotine patches.~   "
21092|NCT02781077|"~     In an observational study, the energy consumption of stroke individuals during performing~     the structured, progressive task-oriented exercise program for walking rehabilitation will~     be measured in order to confirm the intensity demand in the range of moderate to vigorous.~   "
21093|NCT02781064|"~     Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown~     of muscle tissue) but many patients stop taking statins due to less severe symptoms, such as~     muscle pain or fatigue.~      This study aims to determine whether symptoms occurring during statin use are caused by~     statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin)~     vs. placebo.~      Patients will be randomized to alternating treatment blocks of either statin or placebo~     split into six two-month treatment periods. At the end of each period, patients will be~     asked to self-report side effects using a website or mobile app.~   "
21094|NCT02781051|"~     Pilot study to assess a multi-component intervention to increase physical activity among~     breast cancer survivors with depression.~   "
21095|NCT02781038|"~     Patients who smoke and suffer from fractures are worse off than those who do not smoke.~     Orthopaedic patients represent a group that can benefit from physician contributions to~     smoking cessation, and a special opportunity to cue this can begin with the orthopaedic~     surgeon in the acute setting. However, the best way to appropriately counsel these patients~     and assess the impact as a teachable moment remains undetermined.~   "
21096|NCT02781025|"~     The purpose of this study is to investigate the feasibility of using novel decellularized~     tissue matrices to isolate and culture circulating tumor cells (CTCs) collected from~     patients with metastatic solid tumor malignancies.~   "
21097|NCT02781012|"~     This sample-collection study is open to participants in several categories: healthy~     volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed~     with pancreatitis or any stage of pancreatic cancer. All participants will submit urine,~     saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit~     tissue samples if biopsy/ies or surgery is part of the care being provided by their doctor.~     In partnership with Berg Health, LLC, biomarkers will be investigated for potential use in~     early detection of pancreatic cancer, to determine prognosis of patients, and to find the~     most appropriate treatments for patients.~   "
21098|NCT02780999|"~     The aim of this study is to compare the effect of Whale and Colditz static orthosis on pain~     and functional abilities of hand in thumb carpometacarpal osteoarthritis as a unique~     treatment.~      Patients with thumb CMC OA will be recruited at Tecan Hand Center Clinic. Participants will~     be assigned using a randomized allocation in two groups. For group A a Whale orthotic will~     be constructed and for group B a Colditz orthotic. Both static splint will endorse for 3~     months. Inclusion criteria for this study were adult over 18 diagnosed with carpometacarpal~     joint osteoarthritis with a pain intensity during Activities of Daily Living (ADL's) up to 4~     / 10 on the Visual Analog Scale (VAS).~      Patients were excluded from participation if they had: a neurological disorder affecting the~     upper limb; had received previous treatment for their hand problem in the last 6 months~     including an intra-articular joint injection to wrist, fingers or thumb; had fractures or a~     significant hand injury or previous surgery to the wrist or hand; had hand or finger~     tenosynovitis and/ or Dupuytren's disease. Were also excluded patients who did not complete~     Dash Spanish version questionnaire or if they did not sign the informed consent.~      The outcome measure will be pain intensity and functional abilities as measured with the~     Visual Analogue Scale (VAS) and Disabilities of the Arm, Shoulder and Hand (DASH),~     respectively. All measures will be collected at baseline and end of the intervention.~   "
21099|NCT02780986|"~     The investigators aim to assess the efficacy of a multi-component intervention on condom use~     and sexually transmitted infection (STIs) in female entertainment workers and men~     frequenting entertainment establishments (EEs), using a quasi-experimental design. Joo Chiat~     and Golden Mile Complex will be selected purposively as control cluster sites (n=220) with~     follow-up of entertainment workers at 6 weeks. The same sites will be used as intervention~     sites after a 3-months 'wash out' period. Self-reported condom use, vaginal swab samples for~     polymerase chain reaction (PCR) for cervical gonorrhoea and chlamydia infections, and throat~     swabs for culture for pharyngeal gonorrhoea will be assessed. Clark Quay will be the~     intervention venue for the heterosexual men while Tanjong Pagar will be the equivalent~     control site. Using time location sampling, cross-sectional samples of men patronising these~     establishments will be assessed on self-reported condom use at baseline (n=600) and 6 months~     after the intervention (n=400) in both intervention and control groups.~   "
21100|NCT02780973|"~     Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples~     once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is~     measured after extraoral erosion.~      Total protein concentration within the formed salivary pellicles on the bovine samples is~     determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH,~     buffer capacity, albumin and total protein content as well as concentration of inorganic~     calcium, phosphate and fluoride) are being measured.~      The aim of this study is to investigate whether gender differences in the salivary~     composition correlate with predisposition to erosion.~   "
21101|NCT02780960|"~     The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in~     detecting residual/recurrent disease in women treated by loop electro-surgical excision~     (LEEP) for CIN1+.~   "
21102|NCT02780947|"~     Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation~     reduces appropriate defibrillator therapies.~   "
21103|NCT02780934|"~     The purpose of this study is to determine whether using a pressure- vs. simple adhesive~     dressing affects the postoperative course and wound healing outcomes following Mohs surgery.~   "
21104|NCT02780921|"~     Perioperative chemotherapy is the gold standard treatment in the resectable and advanced~     gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two~     randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and~     evaluates chemosensitivity. Disease free and overall survival rates were significantly~     improved with perioperative chemotherapy compared to surgery alone. However, the limitation~     of these studies is that among all patients requiring chemotherapy, almost 70% of patients~     will not have the complete sequence. This sequence is defined by the administration of 2 to~     4 cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major~     cause of absence or impossibility of realization of postoperative chemotherapy was the~     presence of postoperative complication, postoperative serious asthenia and impaired~     nutritional and physical status (1,2). Poor physical condition assessed by cardiopulmonary~     exercise testing, reflecting a reduced physiological reserve, is predictive of postoperative~     complications (3,4). A physical training, even during a short period and on a various~     population, is beneficial in improving physical condition, cardiopulmonary function and~     muscular mass of the patient (5-8). A prehabilitation over a 6 week period between surgical~     consultation and surgery decreases postoperative morbidity and the hospital stay in~     cardiovascular surgery but no study has ever been performed in the gastric or oesophageal~     cancer (7,9).~      Prehabilitation revolves around three axes: 1) a physical training based on initial~     cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test~     (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure~     the compliance of the nutrition program and adapt the nutritional management based on~     protein and energy needs and on the level of spontaneous oral intake and 2) a psychological~     treatment by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever~     focused on the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be~     particularly important because 1) this surgery is associated with a high postoperative~     morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional~     status of these patients is often precarious (cancer cachexia, gastroesophageal~     obstruction), and 3) the need to preoperative chemotherapy declines physical reserves and is~     associated with a lengthening of the time between consultation and surgery of more than 3~     months (10). Also, the investigators hypothesize that with a physical training, a~     personalized nutritional support and a psychologist management may decrease postoperative~     complications, increase postoperative nutritional status and so, would allow for more~     patients to receive their full cancer treatment. The aim of this study was to evaluate, in~     gastroesophageal adenocarcinoma, the effect of prehabilitation compared to conventional~     care, the percentage of patients reaching the complete oncological treatment decided in a~     multidisciplinary tumour board.~   "
21105|NCT02780908|"~     This project will consist of two studies, each investigating resting and exercise~     cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and~     individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults~     (18-22 yrs).Additional study will be performed on a preterm adult cohort (15 participants)~     that will investigate potential differences between hypobaric and normobaric hypoxia as~     outlined in the following section.~   "
21106|NCT02780895|"~     Implantation of Celavie human stem cells (OK99) is intended to address the underlying~     pathology of the disease by replacing damaged/destroyed cells of the brain, and/or~     stimulating the patient's brain to repair itself.~   "
21107|NCT02780882|"~     The purpose of this prospective open-label phase II study, is to evaluate the efficacy of~     pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol~     in patients with ectopic ACTH-producing tumors as measured by the proportion of patients~     achieving normal UFC at the end of the study period.~   "
21108|NCT02780869|"~     The purpose of this prospective, randomized, controlled study is to evaluate the safety and~     efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device,~     absorbable gelatin sponge USP with thrombin.~   "
21109|NCT02780856|"~     This is a prospective, multi-centre clinical study to evaluate the safety and performance of~     the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either~     sound (inactive) or unsound (active caries lesion present) according to ICDAS staging~     (International Caries Detection and Assessment System). Images of the tooth surface will be~     taken with the Calcivis System immediately before and after application of a disclosing~     solution containing a bioluminescent protein. Presence or absence of elevated luminescence~     on the images will indicate activity / inactivity of the presence or absence of active~     demineralisation on the tooth surfaces.~      The study will be deemed a success if there is 70% agreement and above between:~        1. elevated luminescence and the presence of active caries as determined by the dentists,~          and~        2. absence of luminescence and the determination of a sound tooth surface by the dentists.~   "
21206|NCT02779582|"~     This study is designed to evaluate the within-woman effect of oral micronized progesterone~     (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the~     DivaCup® (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the~     number of soaked normal-sized sanitary products such as normal-sized tampons or pads as well~     as length of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women~     with hot flushes and night sweats who are qualified to enroll in the primary perimenopausal~     hot flush trial stratified by whether they are in Early or Late Perimenopause.~   "
21110|NCT02780843|"~     Acute stroke occurs in approximately 13.000 persons every year in Denmark, 10 - 15 % now~     receives intervenous thrombolytic therapy, which remains the most important acute treatment~     in ischaemic stroke. For more than a decade there has been an ongoing discussion if~     Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) were best before~     thrombolysis: Magnetic Resonance Imaging is superior in visualising ischaemia, but~     Computerized Tomography is quicker and more easily applicable.~      In the investigators centre primary imaging in work up of acute stroke during working hours~     will alternate between Computerized Tomography and Magnetic Resonance Imaging days based on~     a fixed calendar for a 24 months period as a quality development project.~      This study is planned to include patients who have acute stroke imagining during this~     period, a total of 600 patients is expected. The investigators will compare door-to-needle~     time, patient safety, quality of imaging, patients' experience, physicians' decision~     certainty, and use of recourses.~   "
21111|NCT02780830|"~     This is a modular study of AZD2014 in combination with novel anti-cancer agents in patients~     with different subtypes of relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).~     Module 1, a combination with ibrutinib in patients with non-germinal centre B-cell-like~     (non-GCB) DLBCL, will consist of Part A, a Phase I dose-finding arm in which the safety and~     tolerability of the combination will be assessed, and Part B, a Phase II dose-expansion~     phase to assess the efficacy of the combination.~   "
21112|NCT02780817|"~     Inducing a systematic perturbation forces on the hand during arm reaching movement may~     improve adaptation. Error-augmentation (EA) training is relatively new concept in motor~     learning intended to promote the adaptation process. In this study participants will~     practice one session of training on 3D robotic device. Healthy volunteers will be randomly~     divided into two groups: study and control. The study group will carry out the training~     session with EA forces. The control group will carry out the same procedure with null force~     field. Outcome measure are the average size of trajectory error from the straight line and~     level of exertion (borg scale).~   "
21113|NCT02780804|"~     This phase I trial studies the side effects and best dose of entinostat in treating~     pediatric patients with solid tumors that have come back or have not responded to treatment.~     Entinostat may block some of the enzymes needed for cell division and it may help to kill~     tumor cells.~   "
21114|NCT02780791|"~     The purpose of this study is to determine whether the pelvic wall or the ovary represents a~     better location for the maturation of follicles in the context of ovarian transplantation~     after cryopreservation of ovarian tissue before cytotoxic therapies.~   "
21115|NCT02780778|"~     The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the~     efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced~     Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.~   "
21116|NCT02780765|"~     60 post operative patients who are kept intubated overnight & are spontaneously breathing~     will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist~     nebulizer.~      Temperature of inspired gas at the Y piece will be measured.~      Sterile water will be used for HH & Mist nebuliser.~      The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/~     doctor/trained personnel and additional suctioning if required.~   "
21117|NCT02780752|"~     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary ducts~     in the liver resulting in destruction and fibrosis. PSC is associated with increased serum~     levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in~     multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone~     has been shown to prevent progression of autoimmunity in several animal models. This is a~     prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years~     of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic~     fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers~     of response will be monitored during therapy.~   "
21118|NCT02780739|"~     Adaptive reasoning and problem-solving are critical skills that allow for accurate decisions~     to be made based on varying levels of information. In many situations these decisions must~     be made and communicated under stressful, time-sensitive conditions. In such contexts, an~     ability to apply inductive and deductive reasoning to complex, ambiguous, and/or novel~     problems is critical. The objective of the INSIGHT project is to establish a comprehensive~     and rigorous brain training protocol to significantly improve adaptive reasoning and problem~     solving. We will examine a variety of interventions (cognitive training, physical fitness~     training, physiological stimulation, , and combinations thereof) to assess their ability to~     improve adaptive reasoning and problem solving abilities. Multimodal interventions are~     hypothesized to act synergistically to significantly enhance fluid intelligence (Gf) and~     underlying brain structure and function.~   "
21119|NCT02780726|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal~     dialysis chronic kidney disease patients with anemia.~   "
21120|NCT02780713|"~     This is a phase 1 open label single centre study of AZD9496 administered orally in healthy~     volunteers. The study design involves single administration of different forms, formulations~     and doses of AZD9496. The study is designed to investigate these different AZD9496 variants.~     The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the~     different forms, formulations and doses of AZD9496~      This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers.~     Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and~     doses.~   "
21121|NCT02780700|"~     The objective of this Phase II study is to assess the efficacy and safety of nintedanib~     alone or in combination with capecitabine for patients with refractory mCRC after failure of~     at least 2 lines of standard treatment~   "
21122|NCT02780687|"~     Primary objective is to investigate the efficacy in terms of 6 month progression free~     survival (PFS6) and objective response rate (ORR) of afatinib, in patients with~     advanced/metastatic urothelial tract carcinoma who have progressed despite prior platinum~     based chemotherapy.~      Other measures of efficacy include progression free survival (PFS), overall survival (OS),~     disease control rate (DCR), duration of objective response (DOR), and tumour shrinkage.~   "
21123|NCT02780674|"~     To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734~     in adult subjects with type I interferon-mediated autoimmune diseases.~   "
21125|NCT02780648|"~     This is a single center, single arm unblinded prospective study of the safety of pancreatic~     stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline~     resectable, or recurrent pancreatic/periampullary cancers who have previously undergone~     treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated~     radiation treatment, or any combination of these therapies.~      Primary Objective~      • To estimate rates of acute (within 3 months of treatment) grade 3 or greater~     gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for~     pancreatic or periampullary cancers who have previously received other treatment.~      Secondary Objectives~        -  To estimate rates of late (> 3 months after treatment) grade 2 gastritis, enteritis,~          fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in~          patients treated with Linac-based SBRT for pancreatic or periampullary cancers~        -  To estimate rates of local progression, overall survival, metastasis-free survival, and~          progression-free survival in patients with pancreatic or periampullary cancers treated~          with fractionated Linac-based SBRT.~        -  To evaluate the ability of Linac-based SBRT to provide pain control in patients with~          pain related to a pancreatic or periampullary tumor.~        -  To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for~          pancreatic or periampullary cancers.~   "
21126|NCT02780635|"~     In layperson's language state the purpose of the study in 3-5 sentences.~      Previous research has demonstrated that intimate partners can positively influence those~     with PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that~     mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study~     will provide Veterans with PTSD and their partners with a mobile app designed to promote~     engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to~     evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and~     improve relationship quality in Veterans and their intimate partners.~      b) State what the Investigator(s) hope to learn from the study. Include an assessment of the~     importance of this new knowledge.~      Understanding ways to improve the public health impact of public-facing, evidence-based~     mobile apps is critical. This study will test a low-cost, high-touch approach to improving~     the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which~     are already available to the general public and used by over 55,000 new users per year.This~     study will test whether the involvement of an intimate partner in the use of a mobile app~     for PTSD will result in changes in how the mobile apps are used and in relationship quality~     and PTSD symptoms over time. Additionally, this study will test whether the addition of a~     discussion board can improve engagement with the apps and/or outcomes. The study will also~     provide useful qualitative data that can inform the development of subsequent dyadic~     interventions using mobile technologies.~      c) Explain why human subjects must be used for this project. (i.e. purpose of study is to~     test efficacy of investigational device in individuals with specific condition; purpose of~     study is to examine specific behavioral traits in humans in classroom or other environment)~      The purpose of this study is to evaluate how Veterans and their partners interact with~     evidence-based mobile apps for improving PTSD symptoms.~   "
21127|NCT02780622|"~     This is an open-label, randomized, 2-period crossover study, to evaluate the~     pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with~     Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be~     randomized to receive either their warfarin followed oseltamivir and warfarin, or by~     oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a~     washout period of at least 4 days. Participants will continue receiving warfarin once daily~     at a prescribed usual dose throughout the study.~   "
21128|NCT02780609|"~     Phase I: The primary purpose of this study phase is to determine the best dose also referred~     to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose~     melphalan as a conditioning regimen for hematopoietic cell transplant.~      Phase II: The primary purpose of this study phase is to assess the complete response (CR)~     conversion rate.~   "
21129|NCT02780596|"~     This study aims to:~        1. identify which single item or combination of two items perform best in identifying~          problematic infant night wakings and~        2. describe current practices by pediatricians in addressing problematic infant night~          wakings.~      Using a novel computer decision support system in several primary care clinics, caregivers~     accompanying their child to a health visit will be randomly assigned to receive two of five~     items assessing night wakings and/or sleep problems, followed by a validated questionnaire~     for infant night wakings. If caregiver responses to the items suggest a possible sleep~     problem, pediatricians will receive a prompt in the electronic health record identifying a~     possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding~     the content of the visit that day.~   "
21130|NCT02780583|"~     The primary purpose of this study is to determine whether giving injections of anakinra is a~     safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for~     patients who are admitted to the hospital with signs of severe inflammation (macrophage~     activation syndrome) that is potentially life-threatening. Anakinra is a commercially~     available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a~     replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by~     humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of~     inflammation that when generated in excess amounts by immune system cells can result in~     severe dysfunction of multiple organs that can be life-threatening. The specific primary~     objectives of the study are to determine if giving anakinra results in no increased~     infection complications or mortality. Additional data will be collected to determine whether~     anakinra administration results in any other unanticipated side effects in this setting, and~     the effects of anakinra administration on inflammation markers, the overall dose of steroids~     required to treat the inflammation, and the length of hospital stay.~   "
21141|NCT02780440|"~     The purpose of this randomized controlled study is to~        1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan~          area;~        2. Evaluate the effectiveness of home MT versus traditional home exercise program; and~        3. Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic~          stroke subjects with moderate hand deficits. Subjects from occupational therapy at the~          Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular~          accident (CVA) or stroke will be divided into three (3) groups:~             -  Control Group subjects will participate in standard occupational therapy~               rehabilitation protocol plus a traditional home based exercise program.~             -  Experimental group 1 subjects will participate in standard rehabilitation protocol~               plus unimanual home based mirror therapy program~             -  Experimental group 2 subjects will participate in standard rehabilitation protocol~               plus bimanual home based mirror therapy program.~   "
21207|NCT02779569|"~     To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS~   "
21131|NCT02780570|"~     Guillain-Barré syndrome (GBS) is the commonest form of acute flaccid paralysis and the~     incidence is high in low-income countries. In Bangladesh, most GBS patients are poor.~     Therefore patients cannot afford expensive specific treatments like intravenous~     immunoglobulin (IVIg) or plasmapheresis (PE) in part explaining the high mortality and~     disability compared to treated patients in high-income countries. Added difficulty in~     traditional PE is its unavailability and specialized device and manpower dependency. Most~     research in GBS has been conducted in high-income countries, largely in patients with a~     demyelinating form of GBS. Axonal form of GBS is common in low-income and Asian countries~     which has a different pathogenesis, clinical course and outcome than the demyelinating form.~     Very few therapeutic studies have been conducted in low-income countries due to expensive~     existing modalities of treatment. Here, the investigators propose SVPE as a treatment for~     GBS in patients from low-income countries. SVPE is relatively cheap, can be done at the~     bedside without any special device or electricity and eventually is expected to help poor~     severely affected GBS patients in underdeveloped and developing countries. The main outcomes~     will be the safety and feasibility of SVPE since this is yet to be established in the~     resource limited settings. To be able to evaluate the safety of SVPE, additional information~     will be acquired about the frequency of complications in non-GBS patients with a central~     line, treated during the same time period at the same study facility as the GBS patients.~     Severe sepsis due to central line associated blood stream infection and deep venous~     thrombosis in the limb where the central venous catheter will be inserted during or~     following the SVPE procedure, will be defined as severe adverse effect (SAE) and will be~     considered as primary outcome measure for safety. Blood, cerebrospinal fluid and other~     relevant biological specimens will be analysed for diagnosis and screening for infections.~     In addition clinical and neurological outcome assessment will be monitored until discharge~     of the patient from the hospital and up to four weeks since study entry. Confirmation of~     feasibility and safety, will eventually lead to a randomized control trial in future with a~     primary focus on the clinical efficacy of SVPE for the treatment of GBS in developing~     countries as an alternative for the conventional treatment with IVIg or PE.~   "
21132|NCT02780557|"~     The aim of this project is to test whether giving parents advice about book reading is~     effective in promoting language learning for infants from a range of socio-economic~     backgrounds.~   "
21133|NCT02780544|"~     Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered~     in time, the disease can be treated, and impaired vision or blindness can be reduced.~     Premature infants are therefore examined regularly after birth. However, the examination is~     painful and stressful for the infant. Painful experiences might lead to a pathological~     stress response later in life and should therefore be prevented.~      In this study skin-to-skin contact with a parent is tested for relief of pain and stress in~     preterm infants being examined for retinopathy of prematurity.~   "
21134|NCT02780531|"~     The purpose of this study is to identify genetic or other factors in the subjects blood that~     may predispose them to getting a particular disease or tell researchers how the disease will~     behave, for example how fast it will progress or what areas of the body might be affected. A~     second goal is to relate such factors to how such a condition affects the subjects~     clinically as well as how it affects the electrical functions of nerves and muscles.~   "
21135|NCT02780518|"~     Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to~     patients when they are paralysed under general anaesthesia. Their lungs are not moving, but~     the high flow allows oxygen to travel into their lungs. This is called 'apnoeic~     ventilation'. The investigators will be using this for patients undergoing surgery for their~     throat.~   "
21136|NCT02780505|"~     Among patients with chronic kidney disease (CKD), there is association between anemia and~     increased chance of mortality mainly because of cardiovascular diseases and stroke, risk of~     hospitalization, and death prevalence in predialysis patients. Vitamin C plays an important~     role in iron metabolism and application for red blood cell formation. Infusion of ascorbate~     supplementation can reduce oxidative stress among hemodialysis patients. This study aimed to~     assess the effect of vitamin C on patients with continuous ambulatory peritoneal dialysis~     (CAPD).~   "
21137|NCT02780492|"~     Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper~     understanding of DMD natural history. This study aim to assess the natural history of DMD~     through a composite assessment tool capable of capturing disease progression linking~     ambulant and non-ambulant phases of the disease.~   "
21138|NCT02780479|"~     Asthma is the most common chronic disease of children. A short (3-5 day) course of a~     short-acting steroid such as Prednisone or Prednisolone has long been the standard of care~     for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in~     the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the~     advantage of shorter course, more compliance, and more tolerable. This has led many~     emergency departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many~     inpatients have received a first dose of Dexamethasone prior to reaching the inpatient unit,~     leading to confusion about the best plan for these patients. Many hospitalist pediatricians~     continue to give a 5-day total course with Prednisone, but some patients have begun to~     receive a second dose of Dexamethasone 24 hours after the first dose. To our knowledge, no~     studies have been done to compare the efficacy of these two protocols in pediatric patients~     requiring hospitalization. The hypothesis is that a second dose of Dexamethasone is as~     effective as four additional days of Prednisone in hospitalized children with asthma~     exacerbation. This is an open label, randomized control study comparing these treatments in~     children age 2-18 hospitalized with asthma exacerbation who have received a first dose of~     Dexamethasone.~   "
21139|NCT02780466|"~     Septic shock is common in intensive care and its mortality remains high. While new~     treatments have not improved survival, optimization of known and widely used techniques has~     allowed reduction in mortality. Thus improving care given to patients starts with making~     better use of existing resuscitation techniques. Among these practices, mechanical~     ventilation is widespread in the management of patients with septic shock. In large studies~     published in recent years in Europe and North America, 40 to 85% of patients receive~     invasive mechanical ventilation. It therefore appears that a significant proportion of~     patients are never intubated during treatment and management of their septic shock. There is~     no specific recommendation from critical care societies concerning mechanical ventilation in~     the treatment of septic shock. Apart from indisputable situations such as impaired~     consciousness or acute respiratoire distress, the decision whether to ventilate mechanically~     or not is left to the discretion of the physician.~      The aim of this study is to analyze intubation practice in septic shock patients and its~     impact on 28-day survival.~      This multicentric and observational study will be conducted in 30 French ICUs.~   "
21140|NCT02780453|"~     Laparotomy wounds are associated with high rates of surgical site infections (SSI). The~     effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates~     is inconclusive.~   "
21792|NCT02771951|"~     This randomized controlled trial tests the efficacy of a culturally and linguistically~     appropriate, evidence-based intervention to slow weight gain or promote weight loss among~     overweight 6-9 year old Mexican-American children.~   "
21143|NCT02780414|"~     Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement~     that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S.~     pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the~     current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method~     has emerged that more accurately identifies women at risk for preeclampsia, warranting~     improvements in diagnosing Pre-E.~      This sample collection study will obtain serum and urine samples from pregnant women who~     present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E.~     Samples will be used to evaluate and validate the performance of an assay intended to aid in~     assessing the risk of Pre-E.~   "
21144|NCT02780401|"~     This phase I trial studies the side effects and best dose of a vaccine therapy in preventing~     cancer from coming back in patients with non-metastatic, node positive, human epidermal~     growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have~     disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an~     effective immune response to kill tumor cells. Giving multiple vaccinations may make a~     stronger immune response and prevent or delay the return of cancer.~   "
21145|NCT02780388|"~     The purpose of this study is to determine whether MEDI4920 is safe and tolerable in patients~     with adult-onset rheumatoid arthritis.~   "
21146|NCT02780375|"~     Peripheral blood samples will be taken with informed consent from radiotherapy patients~     undergoing standard radiotherapy at The Royal Marsden before and during treatment for~     breast, lung, gastrointestinal and genitourinary tumours. Responses from panels of up to 800~     coding and non-coding RNAs will be assessed in the samples using the nCounter system.~     Candidate genes identified by Public Health England, Columbia University and/or in the~     literature as being specific to radiation responses will be included, together with genes~     relevant to systemic inflammatory responses, to identify transcriptional responses for a~     range of doses and exposures on an inter-individual basis. Data will be analysed using~     existing and new statistical tools focused on count data modelling. The intended outcome is~     identification of a radiation specific panel of genes to inform individual radiation~     responses and if the results are favourable, a large scale follow up to this proposed pilot~     is expected in due course.~   "
21147|NCT02780362|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency~     for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg F.C.T (Bristol-Myers Squibb~     Pharma, UK) in Healthy Human Volunteers Under Fasting Condition~   "
21148|NCT02780349|"~     Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower~     extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)~   "
21149|NCT02780336|"~     The aim of this study is to develop new rating scales to help diagnose and measure the~     severity of blepharospasm. This is a condition involving a lot of blinking and spasms of eye~     closure that people can't control. This study will also test some video software to see if~     it can help diagnose people or tell the severity of disease using only a video recording of~     an exam. There is an additional plan to create an educational video to teach others the~     proper use of the scale and video software.~   "
21150|NCT02780323|"~     This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and~     CELEBREX® in Rheumatoid Arthritis Patients~   "
21151|NCT02780310|"~     The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib~     has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a~     phase II study. Researchers hope to learn if the study drug will shrink the cancer by at~     least one-quarter compared to its present size.~      Lenvatinib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if lenvatinib is a~     useful drug for treating patients with adenoid cystic carcinomas.~   "
21152|NCT02780297|"~     The purpose of this study is to determine the natural history of the hereditary forms of~     nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria,~     Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric~     hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation~     and determine relationship to the disease course. Cross-comparisons among the disorders will~     allow us to better evaluate mechanisms of renal dysfunction in these disorders.~   "
21153|NCT02780284|"~     The purpose of this study has 2 aims:~      Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of~     colorectal cancer to a physical activity intervention trial. Investigators hypothesize that~     it will be possible to recruit and retain this patient population to a physical activity~     intervention trial.~      Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and~     analyzing the gut microbiome data. Investigators hypothesize that all of these steps are~     feasible.~   "
21154|NCT02780271|"~     We will conduct a 2x2 factorial randomized controlled trial to test the separate and~     synergistic effects of an in-person hands-on dietary and physical activity change curriculum~     (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed~     newsletters and an interactive website) on changing dietary and physical activity behaviors~     among a diverse population of Latina breast cancer survivors who have completed breast~     cancer treatment. Participants will be evenly randomized to 4 arms: in-person education~     alone, e-communication alone, in-person education plus e-communication, or control.~   "
21155|NCT02780258|"~     To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands~   "
21156|NCT02780245|"~     This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid~     dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of~     postpartum hemorrhage at secondary CS.~   "
21202|NCT02779634|"~     There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on~     echocardiographic indices of diastolic function in elderly patients with heart failure with~     preserved ejection fraction (HFPEF). In previous studies the only echocardiographic~     parameters studied were ejection fraction (EF) and chamber size. The objective of the~     proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on~     diastolic function assessed by echocardiography in patients over the age of 50 with a~     clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be~     utilized for this study as it has been shown to have superior bioavailability when compared~     to oxidized CoQ.~   "
21157|NCT02780232|"~     Major depression is a highly prevalent and severe mental disease. Interventions based on~     information and communication technologies (ICTs) generate innovative opportunities to~     prevent and to intervene early the depression in adolescents. In Colombia, there are few~     preventive mental health interventions scientifically oriented and seeking to demonstrate~     efficacy in context.~      The purpose of this study is to determine whether an internet-based program is effective to~     prevent and to intervene early the depression in adolescents between 13 and 19 years of age~     in 8 schools of the Antioquia Region, Colombia .~      Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents.~     The efficacy, adherence, and acceptability of the internet-based program will be evaluated.~     A single-blind randomized controlled trial will be conducted with two arms, the intervention~     arm (n=300), which will receive an internet-based program for depression, and the TAU~     (Treatment As Usual) arm (n=300).~   "
21158|NCT02780219|"~     For this study a resistance bout will be performed in order to promote the robust response~     of protein synthesis. Type II muscle fibers often exhibit more atrophy than type I fibers in~     COPD subjects therefore specifically targeting them in an exercise protocol could have more~     beneficial outcome for these individuals.~   "
21159|NCT02780206|"~     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is~     stable and during weight loss induced by very low calorie diet procedure using the~     technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics)~     will enable generation of new hypotheses that could explain the inter-individual differences~     in weight loss and could lead to optimization and individualization of therapies designed to~     lose weight.~   "
21160|NCT02780193|"~     The purpose of this study is to provide intravenous omega-3 fatty acids and monitor~     tolerance in subjects with prolonged parenteral nutrition dependence and parenteral~     nutrition-associated cholestasis through expanded access.~   "
21161|NCT02780180|"~     Heart Failure (HF) a common clinical condition characterized by either by a heart that does~     not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive~     cardiac remodeling and dysfunction.~      A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway,~     may lead to improve HF.~      QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be~     an antihypertensive agent in animal models.~      This study investigates the safety and efficacy of QGC001 in HF patients.~   "
21162|NCT02780167|"~     Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once~     daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the~     efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of~     the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease~     severity in patients with moderate to severe AD as measured by the Investigator's Global~     Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support~     further clinical development of PF 04965842.~   "
21163|NCT02780154|"~     This is a single center, randomized and controlled human study to optimize controlled human~     malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults~     aged between 18 and 45 years, will be randomized to one of five groups and will be~     inoculated with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months,~     while the study duration is planned to be 4 months. The primary objective of this study is~     to assess the safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and~     NF54 P. falciparum strains.~   "
21164|NCT02780141|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive~     hemodialysis chronic kidney disease patients with anemia.~   "
21165|NCT02780128|"~     The purpose of this research study is to match genomic aberrations in tumor cells at time of~     relapse to rationally designed combinations of molecularly targeted agents. This study will~     be done in two parts:~      Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing~     to identify protocol-specified biomarkers for therapy assignment.~      Part II: If the tumor contains a genetic change defined by the study as being actionable,~     and other criteria are met, participants will be assigned to therapy based upon the genetic~     changes identified in the tumor biopsy.~   "
21166|NCT02780115|"~     This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201~     and AGN-190584 in participants with presbyopia (inability to focus on items close-up).~   "
21167|NCT02780102|"~     The investigators administered a randomized controlled trial (RCT) through random assignment~     of children with ADHD into three different groups to compare the effects of cognitive-motor~     rehabilitation, immediate release methylphenidate, and an active control on the executive~     functioning, learning, and behavioral symptoms of children with ADHD.~   "
21168|NCT02780089|"~     This study evaluates the different patterns of care for patients who have unresectable or~     metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be~     observed. The survival rate of these patients will also be observed.~   "
21169|NCT02780076|"~     The survivors after hip fracture often report severe pain and loss of physical functioning.~     The poor outcomes cause negative impact on the person's physical functioning and quality of~     life and put a financial burden on society. It is important to continue and progress the~     functional training that already started at the hospital, while the patients are transferred~     to short-term stays in a nursing home before they are returning to home. The aim presently~     is to examine the effects of a functional training program by a RCT design, initiated by the~     physiotherapist and performed by the nurses, on physical functioning while the patients are~     at short term stays in primary health care.~   "
21178|NCT02779959|"~     Headache is a common presenting complaint to the emergency department accounting for 1-2% of~     patient visits. Of these headaches, approximately 90% are migraine, tension headache, or~     combined presentations. The most commonly used migraine therapy in the ED is intravenous~     prochlorperazine, but its administration requires close nursing observation, a bed, and the~     insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form~     of delivery that enables rapid achievement of therapeutic blood levels and may lead to~     symptom resolution. In a randomized, controlled, prospective study,the investigators plan to~     assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency~     department treatment of migraine headaches.~   "
21170|NCT02780063|"~     Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the~     intraocular lens implant. Lenstar is an optical biometer that calculates the axial length,~     keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are~     routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include~     Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil~     which causes an anterior rotation of the ciliary body, which may affect the Lenstar~     measurements. This study is to determine if dilating medications affect the lens power~     prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will~     be performed on each eye. Patients will receive dilation medication and after waiting 20~     minutes Lenstar biometry will be performed on each eye. Dilation and measurement with~     Lenstar will be done as standard of care. Measurements and calculations from before and~     after will be compared.~   "
21171|NCT02780050|"~     Chest compression, a key component of cardiopulmonary resuscitation (CPR), has a major role~     for survival of cardiac arrest patients. According to 2015 American heart association (AHA)~     guideline, rescuers provide high quality CPR to adult cardiac arrest patients including 5 to~     6 cm depth and 100 to 120 beat per minute rate chest compression.~      However, in CPR situation, chest compression depth and rate vary according to provider's~     muscle strength. In other words, the individual difference of the degree of physical~     activity will make the different result for CPR. So, the investigators hypothesize that the~     core muscles activation using physical fitness improves the quality of chest compression and~     the quality of CPR, eventually.~   "
21172|NCT02780037|"~     This study examines the short- and long-term-effects of different repeated frames in which~     an exercise program is offered on behavior (i.e., frequency of exercise) and motivation~     (i.e., autonomous/controlled) in older people (65+). The frames are manipulated~     experimentally as either prevention focused (e.g., to prevent worse health), promotion~     focused (e.g., to gain better health) or neutral (control condition).~   "
21173|NCT02780024|"~     Glioblastoma Multiforme is one of the most common, and unfortunately one of the most~     aggressive brain tumors in adults with most of the patients recurring and dying of the~     disease with a median survival of 16 months from diagnosis.~      Current treatment for patients with newly diagnosed Glioblastoma Multiforme (GBM) is safe~     maximal surgical resection followed by concomitant conventional Radiotherapy (RT) delivered~     in 6 weeks + Temozolomide (TMZ) followed by TMZ for 6 to 12 cycles.~      Recent scientific research has shown that Metformin, a common drug used to treat diabetes~     mellitus, may improve the results of the treatment in patients with a variety of cancers,~     such as breast, colon, and prostate cancer. Metformin is an attractive and safe medication~     to be used in this group of patients because of its very low toxicity.~      In our center the investigators have been using TMZ for 2 weeks prior to a short course (4~     weeks) of RT which equivalent to the standard RT of 6 weeks. Temozolomide is used 2 weeks~     before RT + TMZ, and this is followed by the 6 to 12 cycles of TMZ. Our results are quiet~     encouraging with a median survival of 20 months, and acceptable toxicity.~   "
21174|NCT02780011|"~     This is an open label phase I trial designed to evaluate the maximum tolerated dose,~     dose-limiting toxicities, pharmacokinetics, and activity of the combination of alsertib~     (MLN8237) and brentuximab vedotin in patients with relapsed/refractory CD30-positive~     lymphomas and solid malignancies. Cohorts of 3-6 patients will receive escalating or~     de-escalating doses of MLN8237 based on a 3 + 3 design.~   "
21175|NCT02779998|"~     Acute respiratory failure is frequent during rhythmology procedure under light sedation in~     high risks selected patients. Non invasive ventilation (NIV) is recommended for acute~     cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric,~     prospective, randomized controlled trial to compare the efficacy of NIV which associated~     pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure~     (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory~     event. Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea~     and hypoxia during procedure in rhythmology under light sedation.~   "
21176|NCT02779985|"~     Effects of foods or food substances on energy expenditure are of particular interest,~     because of the increasing prevalence of obesity and its consequent metabolic diseases like~     type II diabetes and fatty liver disease, all risk factors for the development of~     cardiovascular diseases (CVDs). Recently, the Goji berry (Lycium Barbarum, wolfberry) was~     introduced into the Western diet. L. Barbarum originates from Asia, where it is used to~     improve the health of several organs. Although L. Barbarum is promoted as a super food with~     many beneficial effects, consistent scientific evidence for these effects is lacking. In one~     study, it was found that short-term intake of L. Barbarum polysaccharides - equal to 150 g~     of fresh berries - increased postprandial oxygen consumption. This indicates that L.~     Barbarum might exert beneficial effects on energy expenditure. Furthermore, long-term~     intervention trials have shown beneficial effects of L. Barbarum on lipid and glucose~     metabolism in mice and type II diabetic patients and on inflammatory status in healthy~     elderly. Altogether, L. Barbarum has the potential to be used as a functional food to~     increase metabolic health, but detailed information on the postprandial effects of L.~     Barbarum is missing. We therefore propose this double-blinded, randomized, placebo~     controlled intervention trial to investigate the effect of a single dose of L. Barbarum on~     postprandial energy expenditure substrate oxidation, metabolic flexibility, lipid and~     glucose metabolism and inflammatory markers.~   "
21177|NCT02779972|"~     Aging is associated with numerous changes and adaptations in the cardiovascular system.~     Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial~     function, and ventricular contractility decline. The decline in cardiac function with~     advancing age is typically seen in parallel to reduced physical activity, and it has been~     proposed that lifelong exercise training might attenuate the effects of aging on the heart.~      The cardiovascular system undergoes several age-related changes. For most healthy older~     individuals, the heart generally functions well under resting conditions. Structural and~     physiological changes tend to result in diminished exercise tolerance. However, increasingly~     it has been shown that even some of these changes are more a result of a sedentary lifestyle~     than an age-related phenomenon. Most elderly people tend to become less physically active.~     It is difficult to separate changes intrinsic to the aging process from those arising as a~     result of a sedentary lifestyle.~   "
21179|NCT02779946|"~     Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the~     metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD).~     CHD is the most important manifestation of atherosclerosis, because of its immense morbidity~     and mortality. Transient elastography (TE, Fibroscan®) including the currently developed~     controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver~     fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD.~     Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk~     assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be~     screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical~     and laboratory parameters. Patients will be stratified for the presence of CHD based on the~     angiography results and correlation analysis with liver fat content will be performed. NFALD~     screening will be validated in a subgroup by MR-based measurements.~   "
21180|NCT02779933|"~     A retrospective, observational study compiled data from all consecutively admitted patients~     older than 18 years at ICU University Hospital in Olomouc in the period from 1 January 2011~     to 31 December 2015 who fulfilled the criteria of HAP. The aim was to determine the severity~     of the specific risk factors of early and late HAP. Risk factors were divided into factors~     from the patient and from the hospitalization. Furthermore, an assessment of their~     relationship to mortality.~   "
21181|NCT02779920|"~     Gastroparesis is a common chronic condition, disabling the limited therapeutic resources~     justifying the exploration of new therapeutic possibilities.~      By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy~     pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of~     choice in the refractory gastroparesis with drug treatments by attacking the pyloric~     obstacle often spastic that counteracts an effective gastric emptying.~   "
21182|NCT02779907|"~     This community-based cross-sectional survey will estimate the frequency and risk factors of~     Chronic Suppurative Otitis Media and Hearing Impairment in Children ages 4-6 years in the~     Chikwawa District. These data will be useful for service planning, disease prevention~     efforts and to guide future research in this field.~   "
21183|NCT02779894|"~     This project develops a new form of management of subjects with suspected SAHS and different~     sleep disorders by applying Information and communications technologies (ICT).~   "
21184|NCT02779881|"~     Epigenetic mechanisms have been implicated in the pathogenesis of food allergy. The~     investigators previously demonstrated that tolerance acquisition in children with~     Immunoglobulin E- (IgE) mediated cow's milk allergy (CMA) is driven by epigenetic modulation~     of the Th1 and Th2 cytokine genes. A regulatory T cell (Treg) suppressive phenotype,~     characterized by stable expression of the transcription factor Forkhead box Protein 3~     (FoxP3), plays a pivotal role in food tolerance. FoxP3 mRNA expression is lower in children~     with atopic asthma or IgE-mediated food allergy than in healthy children. FoxP3 stable~     expression requires full CpG demethylation of its transcriptional regulatory regions, and,~     moreover, hypermethylation of the FoxP3 gene has been associated with reduced Treg function~     and allergy.~      DNA methylation is a biologically and chemically stable epigenetic modification that locks~     in long-term gene expression patterns. The demethylation status of FoxP3 at a highly~     conserved region within the Treg-specific-demethylated-region (TSDR), a CpG-rich, located on~     the 2nd conserved non-coding sequence of FoxP3 (CNS2), is restricted to Tregs.~     Transcriptional activity of the TSDR is essentially determined by its methylation status :~     it is completely inactive in its methylated state, but when the TSDR is demethylated,~     transcription factors such as Ets-1 and Creb can bind to the TSDR. TSDR demethylated and~     open chromatin conformation in the Foxp3 locus leads to stable phenotype differentiated~     Foxp3+ Treg. FoxP3 TSDR demethylation in peripheral blood mononuclear cells (PBMCs) has been~     associated with reduced atopic sensitization and asthma in children. Epigenetic regulation~     of antigen-induced T-cell subsets may predict a state of immune tolerance in food allergy.~     Indeed, DNA methylation of the FoxP3 gene in Tregs decreased during oral tolerance~     acquisition in patients with peanut allergy undergoing oral immunotherapy. The aim of this~     study was to evaluate further the epigenetic regulation of FoxP3 gene in children with~     IgE-mediated CMA.~   "
21185|NCT02779868|"~     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering~     from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly~     by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects~     in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could~     potentially maintain body weight in cancer patients undergoing intensive treatment.~      The investigators aims in this study is to evaluate the effect of omega-3 supplementation on~     body composition, functional capacity, inflammatory profile and quality of life in cervix~     cancer patients undergoing chemoradiotherapy.~   "
21186|NCT02779855|"~     The purpose of this study is to determine if an oncolytic virus called Talimogene~     laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells~     while leaving normal cells alone) injected directly into the tumor during chemotherapy prior~     to surgery can enhance the elimination of triple negative breast cancer tumors. The natural~     herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene~     laherparepvec version of the herpes virus has been changed to prevent it from reproducing in~     normal tissue.~      However, it can still attack and break open cancer tissue which is why it is used as a~     treatment for cancer. It is thought that this virus can also help recruit the participant's~     immune system to attack the cancer cells during their treatment and possibly destroy the~     tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to~     treat melanoma skin tumors, so investigators want to determine if this virus can achieve a~     similar benefit in women with triple negative breast tumors.~   "
21187|NCT02779842|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
21188|NCT02779829|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
21189|NCT02779803|"~     A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients,~     specifically, patients with carotid occlusion and symptoms refractory to medical therapy and~     evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox~     Challenge SPECT Scan). This subgroup includes:~        1. Hospitalized unstable patient with crescendo or postural TIA's~        2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite~          medical therapy.~   "
21190|NCT02779790|"~     Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an~     important therapeutic goal for overweight and obese patients to reduce their risk of~     developing cardiovascular disease and diabetes. Liquid meal replacements (LMRs) are simple~     tools that may aid in weight loss and may improve weight-related risk cardiometabolic risk~     factors. There is a need to synthesize the evidence on LMRs and cardiometabolic risk to~     inform clinical practice guidelines. The authors propose to conduct a series of systematic~     review and meta-analysis of randomized controlled trials to evaluate the effect of LMRs on 4~     areas of cardiometabolic risk: markers of adipsoity, glycemic control, established lipid~     targets, and blood pressure.~   "
21191|NCT02779777|"~     This two-stage study is designed to investigate the antitumor activity of tipifarnib in~     approximately 58 eligible subjects with very low, low or INT risk MDS who have no known~     curative treatment. Eligible subjects may have received no more than 2 prior systemic~     therapies. In the first stage, 44 eligible subjects will be enrolled and stratified in to~     one of four biomarker-defined strata (11 subjects per stratum) based on subject KIR2DS2 and~     KIR2DL2 positivity. Subjects will receive tipifarnib administered at a starting dose of 900~     mg, orally with food, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21)~     in 28 day cycles. At the discretion of the investigator, the dose of tipifarnib may be~     increased to 1200 mg bid if the subject has not experienced dose limiting toxicities at the~     900 mg dose level. Determination of RBC tranfusion independence and disease response will be~     performed by the Investigator according to the MDS/MPN International Working Group (IWG)~     criteria. Similarly, disease progression will also be determined based on the MDS/MPN IWG~     criteria.~   "
21192|NCT02779764|"~     The objective of this study is to evaluate the efficacy and safety of ASP1517 in~     hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses~     Stimulating Agent formulation .~   "
21193|NCT02779751|"~     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in~     combination with pembrolizumab in participants with advanced non-small cell lung cancer~     (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative~     (HER2-) breast cancer.~   "
21194|NCT02779738|"~     The purpose of this study is to evaluate the effect of food on merestinib (standard meal and~     high-fat meal) compared to the fasted state. The study will also measure how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it. In~     addition, the tolerability of the study drug will be evaluated. Information about any side~     effects that may occur will also be collected. The study will last approximately 28 days.~     Screening is required within 28 days prior to the start of the study.~   "
21195|NCT02779725|"~     This project will determine the most important and cost effective components of~     SymptomCare@Home, a new approach to cancer chemotherapy symptom care that has been shown to~     reduce problematic symptoms through automated daily monitoring, self-management coaching,~     and oncology team follow-up care using decisional support for patients at home when their~     symptoms are most likely at their worse. Once the key parts of the intervention and its cost~     effectiveness are known, it can be moved into everyday cancer care.~   "
21196|NCT02779712|"~     Stroke has an enormous impact on both individual and society. Novel treatments are required~     to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC~     refers to applying non-lethal ischaemia to an area distant from an organ you are trying to~     protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be~     neuroprotective and help restore functional outcome when compared to control. These outcomes~     are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very~     soon after the stroke occurs. The mechanisms of protection are unclear but may be due~     enhancing the body's ability to protect itself from further injury by favorably altering~     cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic~     conditioning (IC) is an intervention already applied during cardiac surgery to protect the~     heart from damage and it may be effective after an acute myocardial infarction. The~     investigators therefore plan to conduct a pilot randomised controlled trial assessing the~     feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in~     patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC.~     Secondary outcomes include tolerability, safety and clinical efficacy. The results will~     inform the design of future trials of a potential intervention is that is pragmatic,~     non-invasive and simple to administer.~   "
21197|NCT02779699|"~     To study the pharmacokinetic characteristics of AL2846 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
21198|NCT02779686|"~     This study is being conducted to compare two different genetic tests developed to determine~     an individuals risk of developing serious vision threatening complications from age-related~     macular degeneration (ARMD).~   "
21199|NCT02779673|"~     The purpose of randomized, double-blind, placebo-controlled study was to determine whether~     yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the~     control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.~   "
21200|NCT02779660|"~     The aim of the study is to examine the effect of RIPC on physiological parameters in~     non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique~     bio-date base for further analysis of molecular and genetic mechanisms responsible for~     observed results.~      The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be~     implemented as additional treatment component to reduce AF burden and minimize~     thromboembolic risk.~      Interim Analysis will be done after 73 patients.~   "
21201|NCT02779647|"~     Introduction Overweight and obesity are characterised by excess fat, which results in weight~     gain and is identified by the Body Mass Index (BMI). Studies show that overweight and~     obesity are the result of a complex interaction between genetic and environmental factors,~     which begins prenatally. Various studies have shown that physical exercise is an important~     component of weight loss programmes and that it also benefits the metabolic profile. Other~     authors have reported that greater weight loss is achieved by a programme that includes both~     diet and exercise, rather than either of these alone.~      Aim The aim of this study is to analyse an intervention based on play as a means of~     improving the body composition of children with overweight or obesity.~      Design / Method The design of the Kids-Play study is based on cases and controls. The study~     was conducted in Granada (Spain) from October 2014 to June 2015. The analysis sample of 54~     children was divided into two groups: cases, consisting of 27 children, who participated in~     an intervention programme based on physical activity, play and nutritional advice (to both~     the child and the parents); and controls, another 27 children, who received only nutritional~     advice.~   "
21203|NCT02779621|"~     To explore the potential for vaginal self-sampling to increase participation in cervical~     screening, we offer the option of self-sampling to a group of non-participants in cervical~     screening (intervention), in addition to the routine screening (smear) test. Women in the~     control group will only receive the routine screening invitation letter. The total screening~     uptake rate, 2 months since the recruitment in each group will be compared.~   "
21208|NCT02779556|"~     The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural~     PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.~      The primary aims are to:~        1. test the effectiveness of the ACP diabetes health literacy intervention to improve a~          range of diabetes-related outcomes among rural patients;~        2. compared to usual care, evaluate whether the intervention reduces disparities by~          patient literacy level.~           The secondary aims are to:~        3. investigate whether a threshold or gradient effect exists between the amount of~          follow-up counseling (number of action plans) and intervention effectiveness;~        4. determine the fidelity of all intervention components, and explore any identified~          patient, provider (physician, nurse, health coach), and/or health system barriers to~          implementation; and~        5. assess the costs associated with implementing the intervention from a health system~          perspective.~   "
21209|NCT02779543|"~     This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone~     UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is~     considered the gold standard for sleep assessment. This research is being done because if~     proven to accurately analyze sleep,these devices may make conducting in-home sleep studies~     easier and more affordable in the future.~   "
21210|NCT02779530|"~     Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the~     association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of~     non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the~     CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According~     the sample size planned, a mean difference of total body water delta between groups (control~     vs. polymorphic) of at least allow 10% could be observed.~   "
21211|NCT02779517|"~     By developing an affordable mobile service robot for therapeutic activities in a health~     center environment, this project addresses the issue of both the high cost and man-power~     required to provide rehabilitation for stroke survivors and other patients. Our goal is to~     measure users - clinician and patient - responses to a telepresence robot, VGo, that has~     been modified with a humanoid torso robot, NAO, to facilitate remote communication between~     the patient and clinician, and to complete supervisory exercise coaching.~   "
21212|NCT02779504|"~     The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of~     the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk~     of post surgical infections after orthopaedic endoprosthetic replacement surgery.~      This Post Market Clinical Follow up study is designed to retrospectively establish the~     infection rate of a cohort patients who have received an Agluna® Treated METS implant and~     compare the clinical data to patients that have received an untreated METS implant; in order~     to provide evidence to support the investigators' clinical claims.~   "
21213|NCT02779491|"~     This is a randomized controlled trial to assess the impact of a novel fruit and vegetable~     mobile phone application on fruit and vegetable intakes, knowledge and attitudes.~   "
21214|NCT02779478|"~     A biomarker cohort study design is proposed to study whether specific airway microbiota~     alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a~     cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will~     evaluate the airway microbiome using an aliquot of the induced sputum and upper airway~     samples. Since induced sputum may reflect different regions of the upper/lower airways, the~     investigators will evaluate the upper and lower airway microbiome in a subgroup~     (case-control group) of patients using samples obtained through upper airway sampling and~     bronchoscopy, respectively.~   "
21215|NCT02779465|"~     The purpose of this study is to determine whether vitamin D is effective in the prevention~     of hepatocellular carcinoma in those patients with chronic hepatitis B.~   "
21216|NCT02779452|"~     The purpose of this study is to evaluate the feasibility of using a quantitative EEG method~     to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental~     deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM)~     compared to control newborns.~      The second purpose of this study is to determine whether cord blood concentration in~     docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled~     mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to~     evaluate whether this contributes to neonates neurodevelopment status.~   "
21217|NCT02779439|"~     To assess the safety and biological efficacy of therapeutically administered most closely~     HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting~     cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including~     Aspergillus and Candida species for the treatment of viral infection following allogeneic~     blood or marrow stem cell or solid organ transplantation.~   "
21218|NCT02779426|"~     The purpose of this study is to determine if sending text messages with treatment reminders~     and facts regarding atopic dermatitis (AD) to caretakers of children with AD will have a~     positive effect on the disease severity.~   "
21219|NCT02779413|"~     This study is conducted in Asia. The aim of the study is to evaluate safety and~     effectiveness in patients of all age groups excluding less than 12 month old infants with~     diabetes mellitus in routine clinical practice in Korea.~   "
21220|NCT02779400|"~     The purpose of this study is to assess the measurement conformity of an in vitro diagnostic~     device measuring the INR (International harmonized Ratio).~   "
21221|NCT02779387|"~     This study is a multicenter, randomized-control-trial. This study select 1184 Infertile~     patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going~     to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a.~     Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted~     reproductive treatment rate, miscarriage rate, live birth rate will be recorded.~   "
21267|NCT02778789|"~     Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by~     performing a comprehensive analysis of the periarticular bone changes in RA patients treated~     with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral~     quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and~     quantifying bone microstructure in RA patients. Quantitatively assessing the changes of~     erosions volume, osteophytes size and the area of cortical fenestration in a group of~     TNFi-treated and a group of tocilizumab- treated RA patients.~   "
21222|NCT02779374|"~     Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small~     embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the~     affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is~     supposed to secrete trophic factors.~      Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in~     resuming the ovarian function after chemotherapy-induced ovarian insufficiency.~      Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes.~     Several small studies examined the use of autologous BMT both in animal and in human. The~     results of these studies were promising. Intravenous injection is simpler and less invasive~     than ovarian injection as the later involves the use of laparoscopy. However, intravenous~     injection has not tested until now.~   "
21223|NCT02779361|"~     Open label phase I clinical trial in healthy volunteers designed to assess changes on~     steroid profile after green tea consumption.~   "
21224|NCT02779348|"~     The purpose of this study is to determine whether multiple-dose administration of nebicapone~     affects the pharmacokinetics of warfarin.~   "
21225|NCT02779335|"~     The purpose of this prospective study seeks to assess ability to achieve enteral feeding~     goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.~   "
21226|NCT02779322|"~     This study try to identify differences in cost, length of operation and results between two~     different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the~     Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish~     public health system hospital.~      The patients of the trial will have the preoperative studies, hospital treatment during the~     admission, postoperative treatment and follow up as any other patient included in the~     hospital bariatric surgery program. No new methods are applied other than randomly choose~     the surgical technique.~      Patients will be randomized in a 1:1 ratio to each group.~   "
21227|NCT02779309|"~     To develop a mortality risk prediction model that can be applied to the wide spectrum of~     risks that are seen in the home care setting.~   "
21228|NCT02779296|"~     Surgical Site Infections (SSI) represents a significant complication in plastic surgery.~     Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One~     potential method to reduce infection is by applying a thin layer of dermal glue over the~     sutures at the site of incision immediately after the surgery. Conventional closures, such~     as sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48~     hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been~     shown to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed~     in a vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of~     moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to~     be more flexible than previous preparations. The application of dermal glue is rapid, simple~     and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this~     study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection~     following surgery. Patients undergoing breast surgery will be recruited and randomized to~     either a group receiving a layer of glue over sutures following surgery or no treatment.~     Patients will be followed up at 30 days and at 8 months for signs of infection, additional~     complications and the visual appearance of the scars. The cost of treating and infection~     will be calculated to determine if using dermal glue to prevent infection is economically~     feasible. This research has the potential to find a method to reduce surgical site~     infection, which can be applied to other surgeries.~   "
21229|NCT02779283|"~     This phase IB trial studies the feasibility of using a functional laboratory based study to~     determine how well the test can be used to select personalized kinase inhibitor therapy in~     combination with standard chemotherapy in treating patients with newly diagnosed acute~     myeloid leukemia (AML). It also evaluates safety and potential efficacy. Kinase inhibitor is~     a type of substance that blocks an enzyme called a kinase. Human cells have many different~     kinase enzymes, and they help control important cell functions. Certain kinases are more~     active in some types of cancer cells and blocking them may help keep the cancer cells from~     growing. Testing samples of blood from patients with AML in the laboratory with kinase~     inhibitors may help determine which kinase inhibitor has more activity against cancer cells~     and which one should be combined with standard of care chemotherapy. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving a~     personalized kinase inhibitor therapy combined with standard chemotherapy may be a better~     treatment for AML.~   "
21230|NCT02779270|"~     To assess the safety of a sunscreen product when used outdoor.~   "
21231|NCT02779257|"~     Pasireotide binds to somatostatin receptors sst2 and sst5, which can lead to significant~     hyperglycemia. The investigators would like to administer pasireotide as a treatment for~     refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic~     neuro-endocrine tumor.~   "
21232|NCT02779244|"~     The purpose of this randomized, controlled trial is to estimate the safety of early weight~     bearing on post ankle surgery.~      Patients who are indicated to have surgery for unstable ankle fractures by an attending~     trauma physician will be consented for participation in the study. After surgery patients~     will be randomized to either weight bearing as tolerated at two weeks with a cam boot or~     non-weight bearing with a cam boot. Randomization will be performed by number allocation~     with odd numbers in the early weight bearing group and even numbers in the non-weight~     bearing group. The surgeon will be blinded to this until after the surgery. The patients~     will all be placed in a short leg cast post operative and made non-weight bearing for 2~     weeks until sutures are removed which is current standard treatment. Both groups will be~     asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is~     non weight bearing in a cam boot, the latter being standard treatment.~   "
21276|NCT02778672|"~     This is a study of up to 250 participants from birth to 12 months who are having a chest~     x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi.~     Participants will have thermal pictures of their chest taken by trained study staff using a~     Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to~     determine if bacterial pneumonia is present. Results of the thermal images will then be~     compared to the results of the chest X-ray. If additional images of the chest are available,~     additional thermal images will be taken of the same location within 24 hours of the other~     image.~   "
21233|NCT02779231|"~     Hypertension remains one of the most important preventable contributors to disease and~     death. It is the most common risk factor for strokes and myocardial infarctions in the U.S.,~     and is associated with the greatest attributable risk for mortality among all modifiable~     risk factors for cardiovascular events. Over 50 million people are living with hypertension~     in the United States, and hypertension is one of the most common reasons for visits to a~     healthcare provider. Abundant evidence from randomized controlled trials has shown benefit~     of antihypertensive drug treatment in reducing important health outcomes in persons with~     hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease.~      Hypertension is more difficult to diagnose than other common medical illnesses. In most~     cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as~     they do for other common symptomatic illness. Patients are frequently diagnosed after~     presenting with end organ disease (e.g., myocardial infarctions, congestive heart failure,~     strokes, or renal failure). Another complicating aspect related to diagnosing uncontrolled~     hypertension is that multiple blood pressure measurements are needed to establish a~     diagnosis. Blood pressure readings can be falsely elevated in clinic due to the presence of~     an observer or the clinical surrounding (e.g., white coat hypertension). Even if an elevated~     blood pressure reading is identified in a clinic setting, more readings are needed in order~     to make it possible for physicians to decide about the next appropriate medical~     intervention. This need for multiple BP measurements over time often delays both initiating~     and modifying medical therapy for uncontrolled hypertension.~      Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled~     hypertension by reducing diagnostic uncertainty. In fact, home measurements are better~     diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more~     closely correlated with end-organ damage, and are cost effective and well-tolerated by~     patients.~      Patients are frequently asked to record their BP after clinic visits. Historically, patients~     used a hand-written log, but more recently, patients are instructed to use an Internet-based~     web portal that uploads values to the patient's electronic medical record. Compliance with~     either approach relies on effective patient and provider followup, and in many settings,~     nurses or pharmacists will need to call patients to prompt them for their blood pressure~     measurements, which is both a costly and time consuming approach. Therefore, researchers~     need to develop effective, yet low cost alternatives to monitoring home blood pressure.~      This study proposes such a solution. The purpose of this study is to evaluate a simple~     m-health intervention to increase the ease and efficacy of diagnosing uncontrolled~     hypertension and achieve better blood pressure control in hypertensive patients.~   "
21234|NCT02779218|"~     Strokes represent, in industrialized countries the leading cause of acquired motor~     disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000~     new cases of hemiplegia each year. These patients will see their deficit to improve during~     the first 6 months after stroke. This recovery is largely based on brain plasticity~     mechanisms and the rehabilitation has as main objective to optimize these mechanisms.~     However, only 20% of patients hospitalized in a rehabilitation sector recover a functional~     upper limb. This lack of functionality is not only due to overall strength gap but also to~     the predominance of this gap on the extension movements of the wrist and fingers.~      Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain~     stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations~     (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In~     previous studies, the investigators have shown over a 30 minutes session lasting~     facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis~     (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of~     a motor task. For PAS, some studies have shown a greater facilitation when the latter is~     associated with muscle contraction.~      The motor imagery (MI) is imagining a movement without realizing it, it is based on~     mechanisms similar to those of the real movement. This technique also showed its effects as~     an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained~     after a motor drive. Its use in patients with no motor makes its uniqueness and strength.~   "
21235|NCT02779205|"~     The beneficial effect related to the administration of adipose tissue-derived stromal cells~     (ADSC) is demonstrated in various situations of physiological and pathological wound~     healing, thus opening a new field for cell therapy. Despite the use of new technologies,~     management of burns in children as well as congenital malformation such as hypospadias and~     cleft lip and/ or cleft palate can lead to aesthetic and functional sequelae requiring~     multiple surgical procedures. Cell therapy based on the administration of the ADSC seems a~     promising issue in such indications, however, to date no study has been conducted with ADSC~     from a pediatric population. An initial study (Protocol 0808203) allowed us to obtain the~     first samples of adipose tissue from children and to conduct an in vitro comparative study~     on the characterization and properties of the ADSC from children compared to adults. In the~     continuity, this second study aims to complete knowledge on the efficacy and safety of~     children ADSC cell therapy assessed in an animal model of skin wound healing developed in~     the lab.~   "
21236|NCT02779192|"~     SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that~     will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of~     this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing~     an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL~     will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight~     acute NIHL.~   "
21237|NCT02779179|"~     Although RA pathomechanisms remains incompletely understood, periodontitis and RA share~     pathogenic features : genetic and environmental influences, chronic inflammatory disease,~     immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical~     factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated :~     Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic~     spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS~     for example).~      Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG~     has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA~     increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution,~     needing a complex pluridisciplinary treatment approach. Recent studies have reported an~     increased prevalence of RA patients with periodontal disease. Others studies show that~     periodontal treatment induces a significant decrease of the sedimentation rate and of the~     DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with~     RA (given the definition from NIH : an aggravating factor is something that makes a~     condition worse). So periodontal treatment cannot be considered as a RA treatment per se.~     But it is hypothesised that treating periodontitis in RA patients showing signs of~     periodontitis could result in improvement in RA disease activity. To date the role of~     periodontitis as an aggravating factor in these patients remains unclear, and only RCT~     designs can reasonably be used to test this causal hypothesis. There still remains some RA~     patients who have persistent symptoms and frequent exacerbations despite specialist care and~     continuous treatment, so results of treating aggravating factors are needed. As the majority~     of patients will benefit from a systematic evaluation and treatment of aggravating factors,~     the periodontal treatment strategy need to be tested.~      The aim of this randomised controlled trial is to assess the effectiveness of periodontal~     treatment for rheumatoid arthritis patients.~      To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid~     arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The~     hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.~   "
21238|NCT02779166|"~     Celecoxib is commonly used for perioperative pain control for certain orthopaedic~     procedures. It has been shown to be successful in assisting in pain control for knee~     arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded~     randomized controlled trial to determine the efficacy of celecoxib in perioperative pain~     control for hip arthroscopy.~   "
21239|NCT02779153|"~     This is a randomized study exploring the efficacy, safety and steroid sparing ability of two~     doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic~     manifestations requiring steroid use for a minimum of 2 weeks prior to screening.~   "
21240|NCT02779140|"~     This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to~     evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).~     NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin~     BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6,~     placebo:therapeutic, with a total study population of 24. The study duration is projected to~     be approximately 8 months, with subject participation in cohort A being approximately 13~     weeks, and subject participation in cohort B and C being approximately 17 weeks. The primary~     objectives of this study are to assess the safety and tolerability of escalating doses of~     NTM-1632 administered intravenously in healthy adults.~   "
21241|NCT02779127|"~     Endothelium is considered a real member, so it is contributing to determine the vascular~     homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by~     non-invasive study of the variation of gauge of the brachial artery as a result of~     post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events.~     Several recent studies have shown that passive smoking is correlated with endothelial~     dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an~     increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial~     decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to~     smoking in non-smoking subjects, as part of a prospective study and controlled, has never~     been evaluated.~   "
21242|NCT02779114|"~     This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group~     intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3~     phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open~     three arm treatment phase for each patient, followed by a 5-year observational phase for all~     patients still in remission.~   "
21243|NCT02779101|"~     In summary, there is a high medical need for patients suffering from recurrent/progressive~     PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the~     treatment of these patients.~   "
21244|NCT02779088|"~     This cohort study will establish the urban elderly cohort, measure both physical and~     functional parameters, find the risk factors for aging, and validate the role of strength~     training for those sarcopenic patients. Investigators hope this study will be widely cited~     in related fields in the future.~   "
21245|NCT02779075|"~     The overall aim of the application is to determine the contribution of the elevated incretin~     hormone concentrations seen after certain types of bariatric surgery to the regulation of~     food intake and satiety.~   "
21246|NCT02779062|"~     Infants sometimes experience sudden symptoms such as breathing irregularities or limpness~     that frighten parents and prompt them to seek emergency medical care. While few of these~     episodes are truly life-threatening and require hospital admission, some parents may have~     been so frightened that they will resist returning home from the emergency department with~     their baby even if the objective risk is extremely small. Study subjects (parents of infants~     with an apparent life threatening event) will be contacted and interviewed. Investigators~     want to learn whether or not study subjects would accept returning home after a brief period~     of observation in the emergency department if the physician determines that it is safe to do~     so.~   "
21247|NCT02779049|"~     1. To understand the components of PBMC in MAC-LD patients, including T cells, B cells,~          nature killer cells, and monocyte.~        2. To confirm the phenomenon of reduced PBMC response in MAC-LD patients~        3. To study the proportion of apoptosis and PD-1 expression in T cells among MAC-LD~          patients, MAC colonizers, patients with tuberculosis, and healthy controls.~        4. To study the apoptosis and PD-1/PD-L1 expression in T cells/macrophage from bronchial~          lavage among MAC-LD patients, MAC colonizers, patients with tuberculosis,~        5. To examine the PD-1 gene polymorphism and the correlation with MAC-LD.~   "
21248|NCT02779036|"~     In a randomized-controlled study, the effects of a structured, progressive, task-oriented~     home exercise program to optimize walking competency will be evaluated in subacute stroke~     survivors.~   "
21249|NCT02779023|"~     This study investigates the feasibility, acceptability, and effectiveness of adding~     Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the~     Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an~     established cardiovascular disease prevention program to reduce cardiovascular disease risk~     through the adoption of lifestyle changes related to improvements in diet, stress, sleep,~     and exercise. The study will be conducted among patients with insomnia who are already~     enrolled in the ICHP cardiovascular risk prevention program.~      This is a single-center study, prospective, randomized, controlled, interventional trial~     within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both~     phases of the study, up to 64 total male and female patients enrolled in ICHP who meet~     criteria for insomnia will be recruited. Participants who meet inclusion and exclusion~     criteria for this study, and consent to participate, will be randomized to one of two~     conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four~     in-person appointments and two telephone appointments.~   "
21250|NCT02779010|"~     The investigators evaluated the impact of water, sanitation and hygiene educational~     Intervention and hand washing with soap on the incidence of diarrhea among under-five~     children.~   "
21251|NCT02778997|"~     Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these~     patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the~     symptoms of a SD are often unspecific and the required diagnostics are time consuming,~     expensive, invasive and may involve radiation exposure. In a prospective observational study~     it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of~     shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and~     the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns~     specific for certain shunt dysfunctions.~   "
21252|NCT02778984|"~     A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a~     tight mask thereafter mask is used to make the patient breathing before intubation. Most~     tight masks are actually sold but they have never been compared in studies. The aim of this~     study is to compare air leaks with standard facial mask and QuadraLite masks during~     preoxygenation and induction of anesthesia.~   "
21301|NCT02778347|"~     The purpose of this study is to develop and validate a comprehensive and standardised tool~     for assessment of patient needs in palliative care.~   "
21253|NCT02778971|"~     The main purpose of this study is to explore the impact of an amyloid positron emission~     tomography and computed tomography (PET/CT) scan on physician diagnosis and management,~     including drug management and care practices, for patients with a diagnosis of cognitive~     impairment. This study also intends to capture specific patient-reported outcomes related to~     patient burden, confidence and satisfaction.~      The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain~     etiology for their dementia will benefit from knowledge of amyloid plaque burden status,~     through an alteration of patient diagnosis and management, which will lead to significant~     changes in patient and care partner reported outcomes.~   "
21254|NCT02778958|"~     The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv~     paracetamol during bariatric surgery.~   "
21255|NCT02778945|"~     In the present study, the investigators compare intermediate and deep NMB i.e. the two~     extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving~     intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a~     deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a~     surgical procedure which is considered to be very sensitive for inadequate muscle~     relaxation, elective minimally invasive spinal surgery.~      The primary objective of this trial is to compare the operation time reduction with the help~     of the decreased stiffness of targeted back muscle surrounding the surgical field.~      The changed back muscle stiffness also measured as secondary objective goal by a mechanical~     tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).~      Other observational objectives are divided into the following categories of stakeholders:~     patients, surgeons and anesthesiologists', done by collecting the variety of clinical~     parameters. The following will be collected and compared.~        1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay,~          transfer rate to SICU for post-op. care, post-operative respiratory complication rate,~          and total hospital costs.~        2. For surgeons Post-operative complications in regard to operation field, and evaluate~          surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.~        3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate~          surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's~          side.~   "
21256|NCT02778932|"~     Pars plana vitrectomy is usually performed under general anesthesia including endotracheal~     intubation and muscle relaxation. However, for short procedures anesthesia using a laryngeal~     mask without muscle relaxation is also common in practice. In this observational study the~     incidence of patient movement will be examined between these anesthesia techniques.~   "
21257|NCT02778919|"~     The purpose of this study is to evaluate the efficacy, safety, and dose-response~     relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.~   "
21258|NCT02778906|"~     This is a randomised double-blinded placebo-controlled multi centre study in 98 patients~     with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at~     baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6~     months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the~     follow up period for another 12 months up to month 18. Patients developing arthritis will be~     treated according to local guidelines.~   "
21259|NCT02778893|"~     Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as~     first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI)~     response rate (ORR), prolong time to progression (PFS), improve patient survival.~   "
21260|NCT02778880|"~     This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine~     and intranasal fentanyl in children presenting to the Emergency Department with acute~     extremity injuries.~   "
21261|NCT02778867|"~     The purpose of this interventional study is to test and compare the effectiveness of two~     elimination diets—the 1-food elimination diet (1FED, milk only) and the 6-food elimination~     diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will~     also test the effectiveness of swallowed glucocorticoid therapy in some of the study~     participants for whom diet therapy was not effective.~   "
21262|NCT02778854|"~     The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid~     biopsy in different specimens and in different methods compared with tissue detection .~   "
21263|NCT02778841|"~     Falling of the elderly as one of the greatest issues and major health problems among the~     elderly population has produced a further discussion among gerontologists and physical~     therapists. Moreover, they are considered as one of the major health problems among the~     aging population and by now around a third of 65-year-old adults fall as a minimum once a~     year while 6% of such falls cause fractures. Loss of the balance is the main reason for~     falling among the elderly. Proprioception is the sensory feedback regarding the joint~     position sense and movement which can accordingly lead to a decrease in the postural~     stability and steadiness of the elderly people. Proprioception has shown to be a risk factor~     for falls in older people. proprioception can be modified by physical training. Recently,~     exergaming, the playing of video games with body movements, has been proposed as effective~     strategy to deliver exercise.~      Aim of study: the current research investigates the effect of 8 weeks videogame game~     exercise, conventional balance exercise, and a combined of the two (mixed training) on knee~     proprioception, static balance, and mobility of elderly male. Methodology: The study was~     designed as a single-blinded, randomized, controlled intervention trial. Sixty-four male~     ages 65 years and above were randomly assigned into an exergame group, a traditional balance~     exercise group, a mixed training group or a passive control group. After pretest all~     participant perform 8 weeks of exercise and measured the effects of the training regimens on~     proprioception and other functional outcomes as well as mood states in healthy older adults.~   "
21264|NCT02778828|"~     Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of~     600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true~     that if a dosage is consensus, it goes without saying, because of the interindividual~     variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels~     is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM)~     often gives rise, as known, to dosage changes. It turns out that at present no real STP on~     the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB)~     and the bibliography remains rather poor recommendations, and yet all the elements are~     there: indeed linezolid is an antibiotic whose activity is purely time-dependent. So one~     should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be~     determined:~      -% T> MIC, or percentage of time spent with plasma concentrations above the minimum~     inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the~     residual concentration before the next shot must be> MIC (0.125 to 1 mg / l)~        -  A fortiori it must also take into account the concentration preventing the appearance~          of resistant mutants, amounting to 1.2 mg / l~        -  AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma~          concentration versus time and CMI LNZ Until then, and without real bibliographic~          support, and for the sake of kindness to patients coupled with an economic advantage,~          the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before~          taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and~          75% for the residual).~      Following an observation that 25 to 30% of patients had a C min <1.2 mg / L, and even~     frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be~     insufficient well.~      This study is therefore more imperative to be a pharmacological streamlining and ensuring~     adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And~     in the light of what has already been practiced for other molecules such as mycophenolate~     for example which is carried AUC or miniAUC for example. It would therefore be in the~     achievement of AUC in all patients treated with LNZ for TB MDR / XDR for over a week.~     Achieving this requires AUC obtaining 7 blood samples given day instead of two samples taken~     at present. Indeed one must have in mind that the peak of rational / residual has become~     blurred in this context, and that one of the two goals PK / PD is now filled (Cmin> MIC /~     CMP) but it should not be that not at the expense of the second (AUC). The benefits, direct~     and indirect are multiple and obtaining them is ensured through this protocol. The study by~     analyzing individual data will confirm the accuracy of the dose fractionation 300mgx2 / day~     and at a time to highlight a potential new dosage adjustment that would need to achieve for~     further study, so a substantial gain in terms of efficacy and toxicity via a suitable~     therapeutic monitoring. Secondly, determine which collection points, in these patients,~     these doses will be most interesting to take later in the routine of STP in order to collect~     less points (eg miniAUC MPA) retaining same statistical power to estimate kinetic~     parameters, mainly the AUC (eg aminoglycoside also). Finally in a third phase construction~     on the basis of these individual kinetics of a population pharmacokinetic model with~     highlighting of population parameters and especially co-related variables explaining the~     high pharmacokinetic variability and allowing for following patients to determine the~     individually tailored dose immediately before the first shot and the first assays.~   "
21265|NCT02778815|"~     This study examines the relationship between self-compassion and wellbeing in new mothers~     and whether an online self-help course for new mothers can help to improve their wellbeing~     and self-compassion.~   "
21266|NCT02778802|"~     This study is designed as a prospective study, with the primary endpoint being changes in~     pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.~      Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.~   "
21268|NCT02778776|"~     Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid~     metabolism, especially triglyceride and hypertension are metabolic disorders that play a~     central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular~     morbidity and mortality associated with atherosclerosis, such as myocardial infarction,~     cerebral vascular events, vascular dementia, heart failure and end stage renal disease.~     Recently other complications related with hyperinsulinemia like the prostate benign~     hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome,~     given its low cost and comparable pharmacological effects to the tiazolinedionas (eg~     pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty~     acids and triglycerides, also it produces moderate weight loss, improving the metabolic~     profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes~     mellitus in individuals with impaired fasting glucose.~      A second option for risk reduction would be the addition of inulin fiber type as it has been~     demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.~      It is expected that combination of metformin with inulin produce a beneficial effect through~     farmacological synergism and the impact on fisiopatological changes of metabolic syndrome~     that potentially is considered as an important risk factor for prostate growth.~   "
21269|NCT02778763|"~     Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety~     of CBLB612 following single administration for neutropenia prophylaxis in breast cancer~     patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy~   "
21270|NCT02778750|"~     Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic~     Fibrosis patients to explore microbiome features that are associated with an inflammatory~     phenotype. Investigators hypothesize that temporal and spatial differences in lung~     microbiome are associated with host inflammatory responses.~      While chronic and polymicrobial airway colonization are commonly recognized in cystic~     fibrosis (CF), it is unclear what factors of the microbial environment lead to infection~     with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic~     Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway~     microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be~     three approaches to understanding inflammatory responses; 1) a longitudinal assessment of~     temporal changes in the microbiome over a 6-month period of clinical stability; 2)~     comparison of the regional differences in airway microbiome between lung segments with more~     versus less disease; 3) evaluation of functional aspects of the lung microbiome.~   "
21271|NCT02778737|"~     Chronic pain is a long-term condition which is related to a number of negative consequences~     including reduced productivity at work, increased number of sick leave , depression and~     emotional difficulties among others. Psychological interventions, particular Cognitive~     Behavioral therapies (CBT) are deemed effective in reducing the negative consequences~     following a diagnosis of a chronic pain condition. Though research provides substantial~     evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or~     improve their physical and psychosocial functioning. Also, CBT appears with only small~     effect sizes on variables considered to be core domains in chronic pain. Finally, there are~     criticism targets on the lack of clear mechanisms underlying the process of change in CBT.~      New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on~     changing individuals' relation with their inner experiences. They utilize mindfulness and~     acceptance processes, instead of directly changing or controlling the content of internal~     experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but~     there are very few clinical randomized trials to compare it with traditional CBT.~      The purpose of this study is to determine whether an ACT-based intervention when compared~     with a CBT-based intervention designed for chronic pain patients is efficacious in reducing~     pain interference, pain-related disability, and psychological distress. Also this study aims~     to examine whether any therapeutic effects result due to the effect of acceptance, for those~     participating in the ACT group or control appraisal, for those participating in the CBT~     group. Better knowledge of the mechanism of therapeutic change can help us to recognize~     which patients can be benefit from which approach.~   "
21272|NCT02778724|"~     Rigorous clinical practice assessment is a key factor to improve patient's care and~     prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC),~     fully integrated to usual coronary activity report software, started in Centre Val de Loire~     (CVL) region in 2014.~      CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is~     regularly evaluated and allowed building an exhaustive, and reliable database. This solution~     could easily be developed in other French regions.~   "
21273|NCT02778711|"~     The purpose of this study is to assess the efficacy of anti-IL 17 treatment (secukinumab) in~     patients with known severe allergic contact dermatitis (ACD).~   "
21274|NCT02778698|"~     This expanded access protocol is for children that cannot get enough nutrients from food and~     must receive nutrition through a vein. The standard nutrition given through a vein is blend~     that has soybean fat. If this is given over a long period of time, it can cause problems. It~     can lead to severe and/or permanent injury to the liver.~      It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the~     soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.~      Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered~     under an expanded access protocol as an alternative to the soybean fat blend.~   "
21275|NCT02778685|"~     This phase II trial studies how well pembrolizumab works when given together with letrozole~     and palbociclib in patients with stage IV estrogen receptor positive breast cancer with~     stable disease that has not responded to letrozole and palbociclib. Monoclonal antibodies,~     such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.~     Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as~     letrozole, may lessen the amount of estrogen made by the body. Palbociclib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     pembrolizumab, letrozole, and palbociclib may be an effective treatment for patients with~     stage IV estrogen receptor positive breast cancer.~   "
21330|NCT02777970|"~     The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral~     fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment~     of moderate to severe acute pain.~   "
21277|NCT02778659|"~     This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep,~     cognitive and motor performances and on acute mountain sickness symptoms at high altitude.~     Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high~     altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms,~     cognitive and motor performances will be assessed to determine potential residual effects of~     Zolpidem within such conditions.~   "
21278|NCT02778646|"~     Familial hypercholesterolaemia (FH) is an autosomal dominant somatic mutation commonly~     located on the LDL-receptor, APOB, and PCKS9 gene. The estimated prevalence of homozygous FH~     is estimated at 1 in a million, whereas the prevalence of heterozygous FH ranges from~     1/500-1/200 (0.2-0.5%) of the general population. The majority of individuals suffering from~     FH remain undiagnosed and without treatment. Using preexisting clinical guidelines, this~     study scored patients within national cardiovascular disease (CVD) registries for FH with~     the aim of evaluating prevalence of FH among individuals suffering from premature cardiac~     events within the UK.~      Following scoring of the registry, this study also examined the relationship between~     cholesterol and survival after a premature event in order to understand the possible~     ramifications of untreated FH on patient survival.~   "
21279|NCT02778633|"~     The purpose of this study is to determine fluid responsiveness in critically ill patients by~     measuring mean systemic filling pressure on the intensive care unit.~   "
21280|NCT02778620|"~     The purpose of this study is to determine fluid responsiveness in critically ill patients by~     measuring mean systemic filling pressure on the intensive care unit.~   "
21281|NCT02778607|"~     Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System~     Atrophy (MSA) are degenerative brain conditions for which there are currently no curative~     treatments. To aid the development of new treatment trials, there is a pressing need to~     develop better methods for diagnosing these conditions early, and to track disease~     progression. The PROSPECT-M-UK study will collect standardised clinical data over time.~     Patients will also have the option to have a brain MRI scan, eye movement exam and donate~     blood, skin and spinal fluid samples, with the aim to identify biomarkers that can improve~     the accuracy of early diagnosis and track the natural time course of disease. Control~     participants and those not meeting criteria for Parkinson's disease or other defined~     conditions but are considered by the investigator group to be allied syndromes or at risk~     states (atypical parkinsonian syndromes), will also be examined. Patients can also~     participate via the CBD European registry or in a one-off study assessment through the~     cross-sectional study, which involves completing questionnaires and a blood sample donation.~   "
21282|NCT02778594|"~     The purpose of this study is to determine the effect of three single oral doses of~     nebicapone (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in~     combination with a single-dose of controlled release levodopa 100 mg/benserazide 25 mg~     (Madopar® HBS 125).~   "
21283|NCT02778581|"~     The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with~     a composition related to short, medium and long unsaturated chain fatty acids on patients~     with a diagnose of cognitive impairment or mild to moderate Alzheimer disease~   "
21284|NCT02778568|"~     The aim of this study was to analyze the effects of resistance exercise and training on~     cardiovascular function of peripheral artery disease patients.~   "
21285|NCT02778555|"~     This study sought to develop and validate a brief, daily version of the Pain Catastrophizing~     Scale.~   "
21286|NCT02778542|"~     The goal of this pilot study is to test different approaches to monitor medication adherence~     in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with~     poor blood pressure control will be recruited from the University of Pennsylvania Health~     System practices and offered remote monitoring with electronic pill bottles, bidirectional~     text messaging or usual care. Our aim is to analyze and compare the effects of remote~     monitoring with electronic pill bottles versus bidirectional messaging on blood pressure~     reduction after 4 months.~   "
21287|NCT02778529|"~     This study is being performed to assess how certain chronic disabilities - stroke, upper~     extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from~     healthy subjects in their ability to perform ADLs. By studying the kinematics of the~     respective cohort of study participants as they are assessed performing common activities of~     daily living (ADLS), the investigators research team aims to better understand how impaired~     neural pathways, and pathways that have been impaired at various points along the pathway,~     deleteriously affect ADLs in patients with differing long-term disabilities.~   "
21288|NCT02778516|"~     Dietary sodium intake independently increases the risk of mortality in end stage renal~     disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left~     ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In~     addition, the hypervolemia associated with excessive dietary sodium intake results in the~     need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms~     such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment~     sessions. Although sodium restriction is a universal recommendation for ESRD management, the~     National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the~     Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation~     from data derived from a dialysis population. In addition, The Dietary Guidelines for~     Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day~     for persons with hypertension and/or kidney disease, middle-aged and older adults, and~     African Americans, though there is also little empiric evidence to support this~     recommendation in the general population and none in the dialysis population. Therefore, it~     remains to be demonstrated that a diet with such sodium restrictions is attainable,~     sustainable, safe or beneficial. The investigators propose a double blind randomized~     controlled design investigation to examine the feasibility of assessing the effects of three~     levels of sodium intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant~     symptom profile, and to compare the effect of hemodialysis-specific variables on participant~     symptom profile during dialysis as well as to explore the role of body fluid composition~     using bioimpedance (BIA) measurements among the three sodium-restricted groups as a marker~     of sodium restriction efficacy.~   "
21331|NCT02777957|"~     First, the aim of the study was to evaluate the usefulness of echocardiographic parameters~     for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred~     for lung transplantation. Second, to assess the prevalence of PH and to identify which~     hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical~     parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with~     severe lung diseases referred for lung transplantation.~   "
21447|NCT02776449|"~     The main aim of this study is to determine the trans-laminal cribrosa pressure difference~     (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine,~     upright and minor head down tilt positions. It is also to investigate the venous drainage~     system in the same body positions.~   "
21289|NCT02778503|"~     Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental~     caries, applying the partial caries tissue removal philosophy using hand instruments,~     relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and~     avoiding local anesthesia. The chosen material for this study will be the High Viscosity~     Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its~     applicability in challenging clinical situations where other materials would not be~     adequate. Although there are substantial evidences regarding GIC properties, information~     about GIC (with different costs) longevity is still weak. Therefore, the objective of this~     study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in~     cavitated dentine carious lesions in primary and permanent molars. This will be a~     multicenter randomized controlled double-blind (patient and operator) clinical trial~     performed with 680 primary and/or permanent molars in children between 4 and 9 years old~     presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces. The~     tooth will be considered as the unit sample, which will be randomly allocated to the groups~     through a generated random list numbers and distributed in dark sealed envelopes opened only~     by dental assistants. Teeth in the test group will be submitted to restorative treatment~     with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration~     effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6~     and 12 months.~   "
21290|NCT02778490|"~     In this pre-post observational study, the investigators will enroll and follow a cohort of~     about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and~     at 6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic~     and imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes~     include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by~     dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone~     structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).~   "
21291|NCT02778477|"~     The current study is the first clinical trial proposed with PF-06423264. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.~   "
21292|NCT02778464|"~     When women with rheumatoid arthritis become pregnant 75% of them will go into remission,~     despite stopping medication. This phenomenon is not well understood and is not seen in other~     inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and~     inside the gut have the ability to effect the immune system and some beneficial bacteria are~     known to down regulate inflammatory components of the immune system. Gut bacteria are also~     known to alter significantly during pregnancy and in other inflammatory conditions there are~     low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is~     significant crossover between rheumatoid arthritis and inflammatory bowel disease with~     similar arthritic symptoms and mechanisms of inflammation. There is very limited~     investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that~     treatment with probiotics and prebiotics can improve the condition. The aim of this study is~     to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and~     identify any significant bacteria changes that might be used to direct future research.~   "
21293|NCT02778451|"~     Ultrasonography (US) is an operator depended image modality that is difficult to reproduce~     and interpret by others. Competence of the US operator is crucial for reliable diagnostics~     but no evidence-based certification of head and neck US skills has been developed.~     Investigators conducted an experimental study aimed to explore diagnostic accuracy and~     establish validity evidence for certification standards in surgeon-performed~     ultrasonography.~   "
21294|NCT02778438|"~     REINVENT is a non-interventional, multi-center, research network-based cross-over study~     evaluating the potential utility of a telehealth platform in improving the efficiency of~     clinical trials. The study aims to enroll 30 subjects from primary care practices~     coordinated through a single main study site. Potential subjects will be screened and~     randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard~     cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7),~     either remotely or during an in-person visit.~   "
21295|NCT02778425|"~     This study compare the efficiency of partial splenic embolization +endoscopical therapy with~     endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with~     splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.~   "
21296|NCT02778412|"~     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may~     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This~     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory~     tests. Measurement of ctDNA has been shown to be useful for following patients with known~     cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in~     individuals without known cancer who are scheduled to undergo a fine needle aspiration~     biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the~     ctDNA test can detect a cancer at a very early stage. The results of this study should help~     define the role of ctDNA in the detection of early stage thyroid cancer and to define how~     sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is~     (i.e. how often is ctDNA found in patients with benign thyroid nodules).~   "
21297|NCT02778399|"~     The primary objective of this study is to assess the efficacy and safety of a range of oral~     doses of OBE2109 versus placebo, in reducing endometriosis associated pain.~   "
21298|NCT02778386|"~     This Phase I evaluation of N-MCT in normal volunteers requires sequentially increased doses.~     At each dose level, the safety and pharmacokinetic will be measured. This Phase I trial will~     have the dose range of N-MCT from 200mg - 1200mg per patient.~   "
21299|NCT02778373|"~     This study sought to examine differences in resistance exercise performance, as measured by~     the kinetic and kinematic profile during multiple sets of the back squat exercise, following~     ingestion of high or low molecular weight carbohydrate beverages.~   "
21300|NCT02778360|"~     The main objective of the study is to demonstrate the non-inferiority of the personalized~     Neurofeedback Training device versus Methylphenidate in the treatment of children and~     adolescents with Attention-Deficit/Hyperactivity Disorder.~   "
21302|NCT02778334|"~     Introduction and literature review With 130 000 cases per year in France in 2010, stroke is~     one of the most common neurological diseases, often leaving many disabling sequelae physical~     and cognitive levels (currently live 500 000 disabled following a stroke) and leading and a~     loss of significant autonomy in these patients. However, many stroke survivors soon find a~     range comparable to their previous state. Investigators can then ask ourselves about the~     impact of this life event in these people who apparently do not show visible effects: what~     about the psychological repercussions of stroke in these patients healthy; what is changed~     in their daily lives, particularly in their mental functioning after this brutal~     confrontation with their own mortality?~      Objectives Our project aims to better understand the psychological repercussions of stroke~     in patients who quickly find a health and autonomy comparable to their previous state. The~     objective will be to investigate the relationship between depressive symptoms and anxiety,~     coping strategies and quality of life from the acute phase and during the first months after~     the onset of stroke. This period is particularly demanding for these patients must therefore~     adapt and readjust continuously: shock stroke, hospitalization in several services~     (intensive care, neurology, rehabilitation), back home, new life with the changes related~     stroke, resumption of a professional activity, etc ...~      Our methodology will combine tools conventionally used (standardized interview, validated~     questionnaires) to newer, ecological and true methods (Experience Sampling Method applied by~     the use of a smarphone application) to assess different variables studied.~      This initially be determined whether the various symptoms of the depression on the one hand~     and anxiety on the other hand, depending on their mode of expression (vs. outsourced~     internalized; ie emotional, cognitive, somatic), observed from the acute phase of stroke,~     are related and predict the quality of life, depression and anxiety in the longer term (four~     months after the stroke).~      Furthermore, our study will observe if the individual coping strategies (coping) daily and~     evolution influence the psychological status and quality of life during the months following~     the stroke.~   "
21303|NCT02778321|"~     Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of~     small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However,~     up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called~     cryptogenic IC.~      Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of~     paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC~     cryptogenic pace. Recognition of these episodes is of great importance since they have the~     same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.~      Several recording techniques heart rate were evaluated after the IC for detecting the AF.~     Their profitability increases with the duration of the recording: about 3% for a typical~     24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to~     12-23% for 30 days and 17-26% with implantable recorders long.~      Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI~     without the significance of these episodes is known.~      Investigators decided to conduct this study because there is no prospective study of good~     quality with a sufficient number of patients that evaluated the interest of a non-invasive~     recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous~     implantable monitor (Reveal XT).~      To clarify the significance of arrhythmias and because the presence of several causes is~     common after 65, investigators propose to record all patients hospitalized for HF.~   "
21304|NCT02778308|"~     Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher~     incidence has been noted in Chile, Mexico and Southwest American Indians.[1] It is the third~     most common malignancy in India.[2] The disease may mimic benign disease in presentation.Up~     to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.[4]~     With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease~     and 63% for stage III have been reported.[5] Treatment of choice is complete surgical~     resection.~      The role of chemotherapy and radiotherapy is not very well documented in treatment of~     gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional~     lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant~     chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or~     without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin~     was found to be more effective than gemcitabine alone and provides definite survival~     advantage and progression free survival.[6] An earlier randomized trial done to assess the~     efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement~     in disease free and overall 5 year survival.[7] But this study has included patients with~     suboptimal resection and all pancreato-biliary malignancy.~      In view of these observations this study is being designed to assess the efficacy of the~     chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone~     curative resections.~   "
21305|NCT02778295|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of a Fabry~     disease from plasma~   "
21306|NCT02778282|"~     The goal of the MySafeRx study is to evaluate the feasibility, acceptability, and usability~     of a novel platform that integrates text messaging reminders, secure electronic pill~     organizers, and daily remote brief motivational recovery support visits with a standardized~     protocol for supervised self- administration of buprenorphine via videoconferencing.~   "
21307|NCT02778269|"~     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)~     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).~     Various studies have shown that hypoglycemic episodes are strong predictors of~     cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and~     small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about~     the direct association of hypoglycemic events and/or rapid swings in blood glucose with~     arrhythmias in this high risk population. Ideally, an algorithm should help to identify~     patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic~     analyses of blood glucose values and 12-channel ECGs are lacking in these patients.~      In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data~     logging device wich can record long-term 12-lead ECG data will be tested. The purpose of the~     T-shirt is to improve the patient's comfort for long-term recordings and to prevent adverse~     effects of regular ECG electrodes. Current systems are limited by the use of ECG electrodes~     involving disadvantages like severe direct side effects on the skin such as rash and bullous~     lesions as well as slipping electrodes. By the means of the proposed ECG T-shirt those~     drawbacks will be avoided.~   "
21308|NCT02778256|"~     Vestibular stimulation has been shown to be a very effective noninvasive treatment for major~     depression. Bipolar disorder is a mental illness that presents cyclic sequences of~     depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat~     and usually are resistant to actual available treatments. This study investigates the~     effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar~     type I and II patients. After randomization 60 of them will receive specific vestibular~     stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study~     will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.~   "
21309|NCT02778243|"~     Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a~     prostatectomy.~        -  Patients justifying prostatectomy together with the bladder (radical cystectomy for~          bladder cancer).~        -  Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum~          sexual steroid concentrations and intra-tissue on healthy prostates and prostate~          adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate~          specific blood sample under study (30mL) will be performed preoperatively in Patients~          followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of~          prostate tissue or metastasis will be analyze.~      Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy~     prostates and prostate adenomas compared to concentrations measured in patients operated for~     prostate cancer.~   "
21310|NCT02778230|"~     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber~     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota~     composition and activity.~   "
21311|NCT02778217|"~     Culture media used to support development of zygotes to the blastocyst stage is based on two~     basic philosophies: a single step medium let-the-embryo-choose or a sequential medium~     back-to-nature.~      For single step media, there are two types of protocol can be used for the culture of human~     preimplantation embryos:~        1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of~          embryo culture~        2. Uninterrupted single embryo culture, in which the same single medium is used throughout~          the 5-6 days of culture with no replenishment or replacement on Day 3.~      Investigators aim to compare the blastocyst development and clinical outcome between the two~     types of protocols of a single medium (with or without renewal on Day 3)~   "
21312|NCT02778204|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of maraviroc in~     infants at risk for mother-to-child HIV transmission and determine an appropriate dose of~     maraviroc during the first 6 weeks of life.~   "
21313|NCT02778191|"~     Concomitant chemoradiotherapy improves overall survival in patients with locally advanced~     head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin~     100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late~     toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative~     but both chemotherapy regimens have not been compared prospectively. The aim of this study~     is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC~     treated with concomitant cisplatin and carboplatin plus 5-FU.~   "
21314|NCT02778178|"~     Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF)~     are established techniques for lumbar interbody fusion. In contrast with posterior~     approaches, they allow free approach to the anterior disc space without opening of the~     spinal canal or the neural foramina. However, the additional anterior approach conveys~     specific concerns, including abdominal pain that may delay recovery after surgery. The~     transversus abdominis plane (TAP) block is a validated approach for postoperative pain~     relief following abdominal surgeries. There is currently no evidence of the possible~     benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The~     investigator hypothesize that a single-injection TAP block reduces opioid consumption after~     anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind,~     placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the~     24h following ALIF/DLIF surgery.~   "
21315|NCT02778165|"~     MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized~     educational format and interactive tracking (wound healing and activity progression using~     photo capabilities and Fitbit flex accelerometer) support during the first 6 to 8 weeks post~     hospital discharge. This application will help patients and family navigate their way~     through the continuum of care by providing an: a) integrated link between acute care and~     outpatient cardiac rehab for efficient coordination of information and reduction in~     duplication of services; b) patient care and education materials designed to address salient~     recovery questions; c) improved communication between the patient and care providers and, d)~     ensure streamlined systematic referral to CR. This innovative strategy has the potential to~     positively impact patient satisfaction, improve patient outcomes and possibly minimize~     financial constraints placed on the health care system. Phase 1 (preliminary usability~     testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample~     of post cardiac surgery patients using a pilot randomized controlled trial (RCT) design.~   "
21316|NCT02778152|"~     Pilot study to assess tolerability and safety of laser hair depilation in adolescents and~     young adults with pilonidal disease.~   "
21317|NCT02778139|"~     The aims of this study were: (1) to examine the risk behaviours, lifestyle and its~     associated psychosocial factors for youth smokers; and (2) to explore the relationships~     among self-esteem, depressive symptoms and quality of life in youth smokers.~   "
21318|NCT02778126|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY2606368 in participants with advanced cancer or cancer that has spread to other parts of~     the body. This study will involve a single dose of ¹⁴C radiolabelled LY2606368. This means~     that a radioactive substance, carbon 14, will be incorporated into the study drug. This will~     provide information about the study drug and its breakdown products and will help determine~     how much passes from the blood into urine, feces and expired air. After a minimum 14-day~     washout period following the [¹⁴C] LY2606368 dose, participants will be allowed to receive~     continued access to LY2606368 as outpatients.~   "
21319|NCT02778113|"~     The main purpose of this study is to evaluate the safety and tolerability of LY900018. The~     study drug will be delivered into participant's nostril (intranasally) or will be given as~     an injection just under the skin (subcutaneously) once in each of four study periods. The~     study will last about 23 days for each participant.~   "
21320|NCT02778100|"~     The main purpose of this study is to evaluate the safety of LY900018 in participants with a~     common cold, some of whom will also take a nasal decongestant. The study will investigate~     how the body processes LY900018 and the effect of LY900018 on the body. The study will last~     up to 30 days for each participant.~   "
21415|NCT02776865|"~     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid~     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for~     treating adhesive capsulitis~   "
21416|NCT02776852|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
21321|NCT02778087|"~     It has been suggested that augmenting repetitive task practice with the use of box (mirror)~     therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an~     opportunity to engage in self-directed practice outside of normally scheduled therapy~     sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for~     practitioners to begin integrating BT into clinical practice situations more information is~     needed to determine what defines a therapeutic dose. The aim of this study is to~     differentiate between two dosages of self-directed BT added to treatment as usual for~     decreasing arm and hand motor impairments, improving activity level, and increasing~     self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation~     Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as~     usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute~     dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham~     BT 5x/week.~   "
21322|NCT02778074|"~     Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new~     innovative and person-centred method that is promising that may be used to decrease~     depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive~     symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity~     and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients.~     Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for~     many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.~      The purpose of this study is to evaluate the effects of the tailored I-CBT program on~     reducing depressive symptoms and other patient reported outcomes in patients with~     cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT~     program in clinical cardiac care.~      Aims of the study~        -  To evaluate the effects of the tailored I-CBT depression program on depressive~          symptoms, sleep, anxiety and quality of life.~        -  To evaluate factors that can influence the I-CBT programs effect on depressive~          symptoms.~        -  To gain knowledge about the I-CBT program, as perceived by patients and health care~          professionals.~        -  To explore facilitators and barriers to the implementation of the I-CBT program in~          clinical practice from the perspectives of patients, health care professionals and~          policymakers.~   "
21323|NCT02778061|"~     Participating investigators will locate all IUB B insertions conducted at their facility at~     least 12 month prior the initiation of study data collection. The study is composed of 2~     parts. Part one is collecting data out of patient's medical record which is accessible only~     to the doctor. This data is mostly demographic. Part two of the study comprises a phone call~     to the patients done by the doctor or by authorized site personnel. In the phone call the~     study purpose will be explained to the patient and a patient consent will be required. After~     the patients consent to participate, the doctor will ask the patient the questions defined~     in the study protocol regarding her experience during the time since the IUB SCu300B's~     insertion.~      A total of 200 eligible subjects will be invited to participate in the study. Informed~     Consent Form will be signed and sent to the investigator, applicable CRFs will be completed~     by the investigator or authorized site personnel. The patient questionnaires will be asked~     on the telephone and entered directly into the CRF by the investigator or authorized site~     staff (CRF = source document). Also the physician´s questionnaire will be directly completed~     in the CRF by the investigator (CRF = source document). All other clinical data will be~     transcribed to the CRF from the medical patient records (patient records = source document).~      There are no planned patient visits to the doctor's office for study purposes. If the~     patient visits the physician´s office as part of the clinical routine, the study procedures~     can also be performed directly at the site instead of telephone contacts.~   "
21324|NCT02778048|"~     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary~     consortium consisting of representatives ranging from clinical medicine via microelectronics~     towards biomaterial science aims to develop a novel implant to treat faecal incontinence.~     The aim of this campaign includes development of implantable prototype devices acting as~     artificial continence muscles using low-voltage electrically activated polymers (EAPs)~     controlled by implemented pressure sensors and the patient.~      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal~     sphincter complex are of cardinal importance. Most of the existing data on anatomy and~     physiology results is based on old studies and almost no data on biomechanical properties~     are available. However, new technologies or even merging data from different examination~     methods might provide new information in this field.~   "
21325|NCT02778035|"~     This trial will compare the efficacy of three different patterns of twice-daily rTMS in~     major depression: rTMS delivered at 0 min vs. 30 min vs. 60 min intervals. The trial will~     include structural and functional MRI, EEG, and behavioral measures obtained before, during,~     and after treatment.~   "
21326|NCT02778022|"~     The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child~     behavior problems and improving parenting capacity and skills at 2 primary care clinics in~     Philadelphia.~   "
21327|NCT02778009|"~     Using FitBit activity monitors, physical activity levels and sleep will be monitored in~     first year medical students~   "
21328|NCT02777996|"~     ITALUNG is a RCT for the evaluation of the efficacy of lung cancer screening with low-dose~     Computer Tomography (LDCT) , carried out in three screening centers in Florence, Pisa and~     Pistoia districts of the Tuscany region of Italy.~      3106 high risk subjects (age 55-69, smokers or ex-smokers) were recruited and randomized to~     the Active arm (Baseline + 3 annually repeated LDCT screening) or to the Passive arm,~     followed up in usual care (no screening reccomended ) All subjects were invited, if smokers,~     to consider smoking cessation practice. Follow-up for cause specific mortality and overall~     mortality and for lung cancer incidence was performed (actually at 9.3 years since~     randomization) . Blood and sputum samples were stored from the Active arm in a Biobank, with~     1304 subjects enrolled in the Italung Biomarker study.~   "
21329|NCT02777983|"~     The purpose of this project is to measure the impact of a short educational session on~     outcomes for patients consulting in primary care for low back pain. Subjects will be~     patients consulting to their primary care provider for a primary complaint and new episode~     of low back pain. Subjects will be randomized to receiving the educational tool versus usual~     care (information only without an educational component) in the clinic immediately prior to~     seeing their PCP. Patients will be followed for a 6-month period, and outcome measures will~     be collected and compared across both groups.~   "
21332|NCT02777944|"~     The aim of this study is to test whether MotivATE can increase attendance at assessment.~     This will be done using a single-consent Zelen randomised control trial, with all~     non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a~     one year period being randomised to either treatment as usual (TAU) or TAU plus access to~     the MotivATE intervention prior to their assessment appointment.~   "
21333|NCT02777931|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus~     placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.~   "
21334|NCT02777918|"~     This is an intervention study, aiming to increase protein intake, by increasing egg~     consumption in community dwelling older adults aged 55 years and over, by providing recipes~     to increase flavour and variety in egg dishes.~   "
21335|NCT02777905|"~     About 10-20% of older patients in primary care suffer from symptoms of depression and/or~     anxiety. Depression and anxiety are associated with higher rates of cognitive decline, lower~     quality of life, increased medical comorbidity, and higher mortality rates in these~     patients. Given the world's aging population and consequent rapid increase in older patients~     in primary care, many traditional therapeutic approaches for depression or anxiety in this~     patient population - e.g. assessment by a mental health practitioner, individual~     psychotherapy and/or appropriate psychotropic medication - have been inadequate, with many~     patients having undetected depression and anxiety. Additionally, geriatric depression and~     anxiety are very common, but difficult to treat with psychotropic medications: patients are~     more sensitive to adverse effects and respond relatively less well to medication.~      To help with this issue, the investigators are conducting a randomized controlled trial of~     mindfulness-based cognitive therapy (MBCT), a treatment that has been highly effective in~     treating depression and anxiety, but has not yet been assessed in older adults. There has~     been relatively little information about MBCT's effectiveness, particularly in the primary~     care setting and in the acute treatment of depression and anxiety(vs. maintenance~     treatment).~      This study will be conducted in 75-100 older adults in primary care with symptoms of anxiety~     and depression. The study will take place in the centre local de services communautaires~     CLSC Benny Farm, a primary health care centre in Montreal, Canada. Most patients aged 60+~     with symptoms of depression (Patient Health Questionnaire 9 (PHQ-9) score ≥10) or anxiety~     (General Anxiety Disorder-7 (GAD- 7) score ≥10) will be eligible. Patients who are eligible~     for the study will be randomized: half the patients will get 8-week MBCT with a trained~     interventionist (occupational therapist, psychiatry resident, or psychiatrist). The other~     half (control group) will get patient treatment as usual with patient primary care~     physician/primary care team during the study, but then after the study, patients will be~     offered the treatment if patients would like.~   "
21336|NCT02777892|"~     Multi-center, Observational Registry with Retrospective Enrollment and Prospective~     Follow-up.~      The aim of the registry is to document the feasibility and safety of implanting an Edwards~     SAPIEN S3 transcatheter heart valve in the pulmonic position~   "
21337|NCT02777879|"~     This is a cross sectional case controlled study to assess lung microbiome and inflammation~     in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will~     look at active bacterial metabolic pathways in the lower airways using metagenomic and~     metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and~     host immune responses in COPD and controls. Investigators believe COPD cases will have~     higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.~   "
21338|NCT02777866|"~     The purpose of this study is to determine if the infiltration of 0.5% Bupivacaine in the~     surgical wound is effective to diminish the pain and the risk of surgical site infections in~     patients who go to a open gastrointestinal procedure.~   "
21339|NCT02777853|"~     The aim of this research is to explore changes in peripheral/cerebrovascular function and~     insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per~     day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and~     examine whether daily intake of tea can prevent such changes.~   "
21340|NCT02777840|"~     High flow oxygen results in better oxygenation in emergency cases needing rapid sequence~     induction for anaesthesia. Secondary outcome measure is time for any desaturation.~   "
21341|NCT02777827|"~     The purpose of this study is to investigate the pharmacodynamics of single doses of~     abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is~     a potential for once daily treatment of asthma and chronic obstructive pulmonary disease~     (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel~     anti-inflammatory agent. The aim of the clinical studies is to enable further investigations~     in participants with asthma and COPD to evaluate and develop abediterol as an effective long~     acting bronchodilator with an acceptable safety profile compared to other inhaled~     bronchodilators on the market, for the treatment of asthma and COPD.~   "
21342|NCT02777814|"~     There has been no report on whether the patients with colorectal cancer who are also~     inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an~     Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare~     the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the~     outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers~     during chemotherapy and the subsequent follow-ups.~   "
21343|NCT02777801|"~     There has been no report on whether the patients with gastric cancer who are also inactive~     Hepatitis B carriers should receive prophylactic use or preemptive Use of an Anti-viral Drug~     Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the~     prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of~     patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy~     and the subsequent follow-ups.~   "
21344|NCT02777788|"~     The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese~     patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the~     adverse reaction and the reliability.~   "
21345|NCT02777775|"~     The purpose of the research study is intended to use specimens (such as tissue) and medical~     information in the Laboratory of Musculoskeletal Oncology at the Van Andel Research~     Institute for laboratory research in Grand Rapids, Michigan. Small tissue samples of~     cutaneous neurofibromas will be collected as part of this research. The samples will help~     researchers learn more about cutaneous neurofibroma and help them better understand NF1.~     There are many different types of studies, both now and in the future, that can be done~     using the specimens they receive. These include using the specimens and information to look~     for new ways to diagnose and treat Neurofibromatosis Type 1 (NF1). The specimens may be used~     to study how genes affect health and disease, or how genes affect the way a disease or~     condition responds to treatment. Some of these studies may lead to new products, such as~     treatments or tests for diseases. Through this study, we hope to find better ways to~     understand and treat NF1 in the future.~   "
21457|NCT02776319|"~     The objective of the study is to determine the effect of non-invasive brain stimulation on~     craving for tobacco and brain metabolites.~   "
21346|NCT02777762|"~     Getting regular physical activity has many health benefits. Current physical activity~     programs often encourage people to track their physical activity as a way to motivate them~     to continue being physically active over time. However, not everyone enjoys physical~     activity, so tracking physical activity may not be very motivating. This research study will~     evaluate whether a new program—specifically designed to enhance people's enjoyment of~     physical activity—improves people's attitudes toward physical activity compared to a program~     that encourages people to track their physical activity with a mobile app.~   "
21347|NCT02777749|"~     The objective of the study is to compare the efficacy of adductor canal blocks versus~     periarticular bupivacaine injections for pain management in total knee arthroplasty. This~     randomized clinical trial will compare outcomes between adductor canal blocks, periarticular~     bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from~     this study will help determine the most appropriate perioperative pain management strategy~     for patients undergoing a total knee arthroplasty.~   "
21348|NCT02777736|"~     Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell~     lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either~     with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal~     methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS~     prophylaxis (arm C).~   "
21349|NCT02777723|"~     The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with~     dry eye syndrome~   "
21350|NCT02777710|"~     Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common~     gastrointestinal cancers in Western countries and are both associated with significant~     morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the~     newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have~     limited efficacy as single agents in both of these tumor types. Recent preclinical studies~     point towards alternatively activated (M2-type) macrophages as possible culprits in inducing~     local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents.~     We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2~     macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following~     PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I~     dose escalation study in order to evaluate the safety and clinical activity of a combined~     treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in~     patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part~     will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of~     Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical~     activity of the combination at the RP2D.~   "
21351|NCT02777697|"~     The aim of this study is to investigate the predictive dimension of cognitive-emotional~     status of cancer patients on the chronic pain development 6 months after different cancer~     treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy~     ...).~   "
21352|NCT02777684|"~     This study sought to better identify the motivators and barriers to osteoarthritic patients~     practising regular physical activity. This is a crucial step towards enabling each health~     professional to adapt their therapy recommendations, while taking into account the patient's~     overall lifestyle.~   "
21353|NCT02777671|"~     Single centre, randomised, open-label, two-way crossover study to investigate whether~     multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the~     pharmacokinetics of gliclazide.~   "
21354|NCT02777658|"~     The objectives of this study are to assess molecular testing, treatment patterns, and~     associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor)~     mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have~     progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability~     of a third-generation TKI (primary study cohort). Additionally, molecular testing and~     treatment patterns will be assessed among a secondary cohort of patients which will include~     patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced~     NSCLC.~   "
21355|NCT02777645|"~     The nutritional status of CP children may be decreased when children have chewing disorders~     too due to insufficient solid food intake. The objective of this study was to investigate~     growth, dietary intakes and feeding behaviours of children with CP who have chewing~     disorders, and to compare them with their healthy peers.~   "
21356|NCT02777632|"~     The purpose of this work was to study the incidence, types, risk factors and causative~     organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation.~     Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy~   "
21357|NCT02777619|"~     The purpose of this study is to determine pharmacodynamic interactions of propofol and~     dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median~     effective concentration (EC50).~   "
21358|NCT02777606|"~     The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal~     Formula documented in Shang Han Lun) in treating severe sepsis.~   "
21359|NCT02777593|"~     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch~     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending~     thoracic aorta.~   "
21360|NCT02777580|"~     In elderly patients ≥ 70yrs with acute ST-elevation myocardial infarction randomised within~     3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic~     treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading~     dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by~     catheterisation within 6-24 hours or rescue coronary intervention as required, will be~     compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment~     according to local standards.~   "
21361|NCT02777567|"~     The objectives of this study are to assess the safety and efficacy of single agent Tagrisso~     (Osimertinib, hereinafter the study drug) in a real world setting in adult patients with~     advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive~     Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase~     receptor (TKI) therapy.~   "
21458|NCT02776306|"~     The purpose of this study is to evaluate the effects of mirror box therapy on upper~     extremity, motor recovery and motor functioning in patients that have suffered a stroke.~   "
21362|NCT02777554|"~     This study will be conducted in 2 Parts. The purpose of this study is to measure how much of~     apremilast is found in the blood when administered as a once daily tablet compared to a~     twice a day tablet, when given as multiple doses (Part 1) and when administered as a single~     dose under fasting and fed conditions (Part 2). Information on the safety and tolerability~     of apremilast will also be obtained. In addition, the effect of apremilast on certain~     biomarkers in the blood will be evaluated in 16 assigned subjects (Part 1 only). Biomarkers~     are substances such as proteins that tell us how the study drug is working in your body.~      Part 1: This is a multi-center, phase 1, open-label, randomized, two-period, two-sequence,~     crossover study in healthy subjects. The study will consist of a screening phase, a baseline~     phase, two treatment periods, and a follow-up phone call. Each Period will be ten days in~     duration (Day 1 through Day 10) for dosing and sample collection for up to 72 hours post Day~     7 morning dose of Periods 1 and 2. There will be a washout between Period 1 and Period 2.~     Part 2: This is a single center, open-label, randomized, four-period, four-sequence~     crossover study to evaluate the PK and exposure of apremilast following single dose~     administration of different formulations of apremilast. Part 2 will consist of a Screening~     phase, Baseline, four Treatment periods, and a follow-up phone call. Each Period will be~     four days in duration (Day 1 through Day 4) for dosing and sample collection for up to 72~     hours post Day 1 of Period 1, 2, 3, and 4.~   "
21363|NCT02777541|"~     There aren't sufficient randomized prospective controlled trials in pediatric population~     comparing the safety and tolerance of early feeding after PEG placement (3-4 hours). Most~     patients are fasted for at least 12 hours following percutaneous endoscopic gastrostomy. In~     order to decrease the period of fasting, inadequate nutritional support, and hospitalization~     time, the investigators decided to design this study. The additional goal is to establish an~     optimum standard procedure in the group of pediatric patients qualified for PEG insertion~     procedure in Poland.~   "
21364|NCT02777528|"~     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch~     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending~     thoracic aorta.~   "
21365|NCT02777515|"~     Justification Smoking is a major factor for mortality and cardiovascular morbidity. The~     electronic cigarette, sometimes presented as smoking cessation classic is expanding but~     its safety has not been established to date. The smoke from the electronic cigarette is~     mainly composed of propylene glycol, some adverse effects were observed in animals.~      Study Type interventional study assessing the effect of the electronic cigarette Inclusion~     criteria Topics under 35 years presenting to Rhythm of the consultation for a cardiovascular~     evaluation and already smoking the electronic cigarette and that for at least 1 month~      Exclusion criteria~        -  Consumption of traditional cigarettes, nicotine replacement or toxic~        -  Presence of heart disease Primary objective To evaluate in a pilot study the immediate~          cardiovascular effects of electronic cigarette consumption Number of patients 20~          Duration of Study Recruitment in 2015 for an unlimited period of inclusion. Exam time~          is about two hours.~      Procedures performed during the study Physical examination, ECG, Holter-ECG 10 minutes and~     echocardiography were performed before and 15 minutes after the consumption of the usual~     electronic cigarette of the subject.~      No additional follow-up visit is required~   "
21366|NCT02777502|"~     The purpose of the proposed study is to investigate the effectiveness of cannabidiol for~     reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid~     (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of~     marijuana.~      Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and~     increase price-elasticity of marijuana demand.~   "
21367|NCT02777489|"~     The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping~     as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated~     with perindopril.~      There is nonclinical and clinical evidence that a subgroup of human subjects may present a~     decrease in body weight and/or fat mass following treatment with perindopril. Although the~     individual characteristics that determine such effect are still unknown, Gene PreDiT SA~     (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g.,~     single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could~     serve as a potential predictive biomarker of response to perindopril.~      These promising results, along with the fact that perindopril is a medicine already in use~     in clinical practice, led Gene PreDiT SA to decide to proceed with the development of a~     theranostic approach for the treatment of obesity. Such theranostic approach consists on the~     use of CPD genotyping to identify obese subjects that could present improved body weight and~     fat mass reduction following treatment with perindopril.~      The current clinical trial aims to prove the concept and provide data to design further~     confirmatory studies. Additionally this study will evaluate the association between CPD SNPs~     genotypes and response to perindopril; the effect of perindopril in waist circumference,~     waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study~     population.~   "
21368|NCT02777476|"~     This is a post-marketing study for B-Lite® implants that carry the EC certificate for~     marketing in Europe and AMAR certificate for marketing in Israel. To date, hundreds of~     implants have already been implanted in women. The study is open for primary augmentation~     patients only. All surgeries will be performed as per standard practice at the given study~     site. No parallel surgical procedures will be performed at the same session.~   "
21369|NCT02777463|"~     To investigate the correlation between pretreatment ADC value of diffusion MRI and~     pathologic response in patients with borderline resectable pancreatic carcinoma who undergo~     neoadjuvant therapy.~   "
21370|NCT02777450|"~     This study evaluates the predictor value of manual test in lumbar chronic patients blocks.~     Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to~     lumbar facet block or medial branch denervation patient will be evaluated with manual~     provocative segmental movements, lumbar sagittal range of motion, manual segmental movement~     and slump neural test . Immediate, one and six months effect will be registered.~   "
21417|NCT02776839|"~     The objective of this study is two fold, first to explore the potential of context sensitive~     intervention delivery to provide in-situ support for people with depressive symptoms, second~     to explore the detection of daily-life behavior based on smart phone sensor information to~     identify subjects with a clinically meaningful depression level.~   "
21371|NCT02777437|"~     Primary Outcome Measures: Disease free survival~      Secondary Outcome Measures:~      Overall survival~      Adverse events (Mortality, morbidity)~      The proportion of completion of Laparoscopic Surgery~      Estimated Enrollment: Oct, 2016~      Study Start Date: Oct, 2016~      Estimated Study Completion Date: Oct, 2019~      Estimated Primary Completion Date: Oct, 2021~      Groups/Cohorts~        1. Laparoscopic surgery for T4 colon cancers~        2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers~   "
21372|NCT02777424|"~     This prospective, randomized, multicenter study is performed to determine whether~     prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult~     neurological patients with coagulation disorders (PT value less than 60%).~   "
21373|NCT02777411|"~     The objectives of this study are to evaluate the immune response and safety profiles of two~     injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg,~     2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if~     required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.~   "
21374|NCT02777398|"~     Intra-spinal canal tumors are the general term of primary tumors from spinal cord or various~     tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are~     those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most~     common diseases in neurosurgery, and surgery is the most effective treatment. Conventional~     open surgery is required to remove the posterior structures of the spine, which would lead~     to fracture of the posterior tension band, soft tissue injury, spine instability, and even~     spine deformity. So it is very important to protect and rebuild the posterior tension band~     for the stability of the spine. The team of Dr. John P. Kostuik from the Department of~     Orthopedics and Neurosurgery, the Johns Hopkins University, firstly introduced minimally~     invasive surgery for cervical and lumbar degenerative disease. However it has not been~     applied to the treatment of intra-spinal canal tumors. To date, the microsurgery of~     intra-spinal tumor through the trans-Quadrant channel pathway has not been widely performed~     in clinical practice. The investigators performed the microsurgery of intra-spinal canal~     tumor through the trans-Quadrant pathway in some patients previously and succeeded in the~     surgical treatments. The investigators analyzed the clinical data retrospectively, including~     surgical incision length, the volume of bleeding during operation, post-operative drainage~     volume, post-operative out-of-bed time point, post-operative length of stay in hospital, and~     post-operative visual analog pain (VAP) score. The group of patients using microsurgical~     technique through trans-Quadrant channel pathway showed better outcome compared with the~     group of patients using conventional open surgery. This innovation of microsurgery showed~     fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in~     practice. Since there are some limitations to the retrospective study, it is necessary to~     design a prospective randomized controlled trial of the treatment of intra-spinal canal~     tumors using microsurgical technique through trans-Quadrant channel pathway.~   "
21375|NCT02777385|"~     The study regimen consists of cisplatin and radiation for all patients, the standard~     treatment for head and neck cancer. All patients will also receive pembrolizumab (the study~     drug), and will be randomized to two treatment schedules: either pembrolizumab with~     cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.~      The goal of this research study is to learn which therapy order (adding pembrolizumab during~     vs. after cisplatin and radiation) may be more effective in treating head and neck cancer,~     as well as learn the side effects of these combinations.Pembrolizumab is an immune therapy,~     a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer~     and melanoma. It is not currently FDA approved for head and neck cancer.~   "
21376|NCT02777372|"~     This is a pilot study that aims to evaluate the psychophysiology of premenstrual mood~     disorders (PMDs) at baseline and after treatment with sertraline. Participants will include~     women with PMDs and healthy male and female controls. Participation involves a baseline~     visit to determine eligibility and three study visits that include questionnaires and stress~     reactivity assessment via an acoustic startle paradigm, cortisol, and immune markers, as~     well as hormone and genetic measures. Female participants with PMDs will receive sertraline~     during the premenstrual phase.~   "
21377|NCT02777359|"~     The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at~     embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is~     referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of~     general population. It was shown in the studies in recent years that the risks of~     cryptogenic stroke, migraine, peripheral arterial embolism and decompression sickness in the~     patients with PFO were several times higher than those in healthy people. Therefore, PFO,~     previously considered a condition without the necessity of treatment, causes the attention~     of many experts and scholars around the world. Migraine with or without aura is defined as~     one of the most disabling chronic diseases, since according to WHO, the disability adjusted~     life year caused by migraine was second only to that by non-fatal stroke in 2005. In recent~     years, an increasing number of researches suggested that migraine is closely related to the~     right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common~     cause of RLS.~      The closure treatment for PFO-induced migraine has been gradually applied in several~     hospitals in China. The relationship of PFO with migraine, however, was not evaluated~     systematically based on specific standards, unfortunately leading to non-inclusion of many~     high-risk patients with PFO in the evaluation. The following aspects are to be fully~     recognized: the selecting and screening procedures for the high-risk population with~     PFO-induced migraine; the indications and standards of closure treatment for PFO in the~     patients with PFO-induced migraine; and the possibility that the made-in-China occluders~     substitute for those imported in the prevention from migraine. Furthermore, there is still a~     lack of prospective, multi-center, randomized and controlled studies in this subject, and~     standard or normal screening and treatment procedures have not yet been established in~     China. From this point, the investigators developed the Chinese people-specific procedures~     and standards of diagnosis of PFO-induced migraine in this study, based on current standards~     and methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign~     countries. And the investigators prospectively adopted continuous inclusion of the high-risk~     patients with PFO-induced migraine, who were randomly divided into the closure treatment~     (transcatheter closure of PFO) group and the medication (drugs administered alone) group at~     the ratio of 1:1., in order to evaluate if the interventional treatment is better than the~     medication alone in these patients, to assess the efficacy and safety of the made-in-China~     occluders in the interventional treatment and prevention of PFO-induced migraine, and to~     identify the incidence of PFO in the patients with migraine in China and develop the Chinese~     people-specific screening protocols of PFO-induced migraine.~   "
21378|NCT02777346|"~     The investigators recruit patients admitted to the Pediatric Emergency Department of the~     Geneva's University Hospital with open wounds needing suture. The patients are treated with~     absorbable versus non-absorbable suture material according to randomization.~      Outcomes are:~        1. infection rate at the first follow-up (between 4 and 14 days, depending on the sutured~          site and defined by protocol)~        2. scar appearance at a 6-months follow-up.~   "
21379|NCT02777333|"~     The purpose of this study is to determine whether simulation training improves the~     performance during arthroscopic surgery ('keyhole' surgery into a joint).~   "
21380|NCT02777320|"~     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for~     the pain treatments.~      The objective of the study was to assess whether intravenous Paracetamol has superior~     Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.~      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.~   "
21381|NCT02777307|"~     Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing~     of postperative fluid collection after laparoscopic cholecistectomy, morbidity and~     postoperative hospital stay.~   "
21418|NCT02776826|"~     The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international,~     observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the~     feasibility of conducting an expanded WBDR to more centres with a more comprehensive case~     report form, around the world.~   "
21382|NCT02777294|"~     Rape is unfortunately a common experience among women, affecting between 13 and 20%. In~     addition, up to 50% of all rape victims experience significant and persistent psychological~     distress. While cognitive-behavioral interventions have been found to be successful at~     alleviating distress among victims; the majority do not seek out these services, often~     because of feelings of stigma and self-blame. One potential method for circumventing these~     barriers is through online administered treatment. Thus, the current project is designed to~     conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media,~     cognitive-behavioral, online intervention tailored specifically for rape victims. The~     effectiveness of this program at ameliorating distress among college women who have~     experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated.~     Reductions in psychological distress was the primary outcome and was assessed at~     post-intervention and at three and six month follow-up periods. The effectiveness of the~     intervention was compared to a psycho-educational website.~   "
21383|NCT02777281|"~     This study will compare two exercise programs in an interventional study for manual~     wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord~     injury will also be enrolled to compare exercise approaches.~   "
21384|NCT02777268|"~     This was a single centre, open-label, randomised, 5-way crossover study.~   "
21385|NCT02777255|"~     Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of~     pathogenetically-related biomarkers, and specific RNA expression changes in the blood~   "
21386|NCT02777242|"~     Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single~     dose via QuickShot® Testosterone (QST) 50 mg, 75 mg, or 100 mg when administered by intended~     users in a usability study.~   "
21387|NCT02777229|"~     Several reports indicate that treatment failure due to HIV resistance or to adverse~     event-related discontinuation could compromise the effectiveness of scaling-up~     antiretroviral treatment (ART), especially when lack of access to viral load is a concern.~     Combined with other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very~     promising alternative to the current first-line non nucleoside reverse transcriptase~     inhibitor-based regimens.~      Initial evaluations of DTG conducted in high income countries showed excellent efficacy and~     safety and indicated high genetic barrier thus preserving second line treatment. As a~     consequence, DTG-based regimens have been recently included in the first-line options in the~     national guidelines for ART of several high-income countries. However, the clinical trials~     evaluating DTG-based regimens have been conducted in highly controlled conditions, including~     baseline resistance testing and regular viral load monitoring. Moreover, these trials~     included a high proportion of men with rare co-morbidities.~      There is need to evaluate how a DTG-based regimen will perform in real-world conditions~     within resources-constrained settings, where viral load monitoring is limited, and where the~     majority of HIV patients are women with important family planning consideration and NAMSAL~     trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48~     weeks of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir~     disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of~     efficacy and safety endpoints will be compared over 48 weeks between the two arms including~     the proportion of patients with viral load <50 copies/mL and incidence of severe adverse~     events.~   "
21388|NCT02777216|"~     To evaluate the safety and performance of the ConfidenHT System~   "
21389|NCT02777203|"~     The purpose of this study is to determine the safety and efficacy of insufflated bags for~     electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for~     tissue removal and to observe the integrity of the bags throughout and after insufflation~     and power morcellation.~      The hypothesis is the bags will remain in tact without leakage from the bags during and~     after power morcellation using the described contained system, confirming the safety and~     efficacy of the systems.~   "
21390|NCT02777190|"~     The purpose of this study is to study if misoprostol administered orally is at least as~     effective as misoprostol administered vaginally for cervical ripening and the induction of~     labor. The main purpose is to show that oral misoprostol administration is non-inferior to~     vaginal misoprostol administration with respect to the time interval from misoprostol~     administration to onset of active phase of labor. The study is a non-inferiority,~     prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2~     hours versus vaginal misoprostol given as 25 mcg every 4 hours.~   "
21391|NCT02777177|"~     Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet,~     not all patients achieve initial weight loss success and many patients have weight regain as~     early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by~     surgical, demographic, and medical factors has led to greater emphasis on patient behaviors~     evidenced by clinical guidelines that focus on appropriate eating and physical activity.~     However, research to inform such guidelines typically has relied on imprecise measures or~     not been specific to bariatric surgery. There is also little understanding of mechanisms by~     which psychosocial factors influence outcomes. Thus, there is a need to: (a) measure~     behaviors and psychosocial factors thought to be related to surgical outcomes (particularly~     those emphasized in guidelines) using innovative strategies to maximize data quality, (b)~     determine which behaviors and psychosocial factors are related to outcomes, and (c) explore~     how psychosocial factors influence weight both directly and via influences on behavior. Our~     research team was the first to employ innovative mobile health (mHealth) technology within~     an Ecological Momentary Assessment (EMA) framework to measure adherence to recommended~     behaviors at 6 months post-surgery. The investigators propose to build on this work by using~     EMA to measure behavioral, psychosocial, and environmental factors over a longer period to~     understand how they predict success and risk after surgery. An NIH-funded multi-sensor PiLR~     HEALTH platform will integrate objective sensor data measuring behaviors and the~     environments in which they are performed with self-report information collected via~     smartphone in real-time and in patients' natural environment. Participants (N=100) recruited~     from 2 ASMBS-designated centers of excellence will complete a 10-day EMA protocol~     pre-surgery and at 3, 6, and 12 months post-surgery to assess recommended behaviors [e.g.,~     meal frequency, PA], psychosocial indicators with the most prior evidence of an association~     with surgical outcomes (e.g., mood/depression), and key environmental factors (e.g.,~     type/quality of the food environment). Participants will also be weighed at the above time~     points. Along with describing patterns in behaviors and their relation to weight loss, the~     investigators will test causal models to understand how complex systems of behavioral,~     psychosocial, and environmental factors affect weight loss, and to identify optimal targets~     for intervention. This project has the potential to build a much more sophisticated and~     valid understanding of who is and is not successful after bariatric surgery and why. This~     new understanding will directly contribute to improved (i.e., specific, consistent, and~     validated) guidelines for recommended pre and postoperative behaviors, which could lead to~     improved surgical outcomes. The enhanced understanding will also inform behavioral,~     psychosocial, and environmental targets for intervention that are mostly likely to improve~     surgical outcomes.~   "
21419|NCT02776813|"~     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and~     efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in~     subjects with refractory or relapsed CD20+ B-cell lymphoma.~   "
21392|NCT02777164|"~     The purpose of the study is to estimate the diagnostic accuracy of cancer detection when the~     MIRA technology is combined with mammography, in women above 30 years old who are undergoing~     screening mammography or are scheduled for image-guided needle biopsy due to lesions~     detected by other imaging modalities.~      The hypothesis is that breast cancer screening based on functional imaging will result in~     the early detection of breast cancers, at times predating mammographic conspicuity. In~     addition, breast cancer screening based on functional imaging will be unaffected by breast~     density. therefore, the combination of anatomic screening (mammography) and functional~     imaging based screening (MIRA) will result in significantly higher breast cancer detection~     rates in women with dense breast tissue by indicating the need for additional breast imaging~     technology, usually MRI.~   "
21393|NCT02777151|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study~     evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of~     REGN3470-3471-3479 in healthy adult volunteers.~   "
21394|NCT02777138|"~     The accumulation and dysfunction of excess adipose (fat) tissue that occurs with ageing is~     associated with a number of chronic inflammatory disorders such as type 2 diabetes and~     cardiovascular disease but the underlying mechanisms are not understood.~   "
21395|NCT02777125|"~     This study is determines if metered dose inhalers are as effective as breath actuated~     nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients~     presenting to the emergency department. Half of the participating patients received~     albuterol via the metered dose inhaler whereas the other half received albuterol via the~     breath actuated nebulizer.~   "
21396|NCT02777112|"~     There is a pressing need for innovation in prevention of major depression in male workers.~     Major depression (MDE) affects workers' health and productivity. In the United States,~     workers with depression cost an estimated US $44.01 billion per year in lost productivity.~     One of the severe consequences of having MDE is potential suicide and Canadian national data~     showed that 76% of all suicides in 2009 were male. In the workplace, risk factors for having~     MDE differ for men and women. For instance, job strain, family to work conflict and job~     insecurity seem to be more prominent MDE risk factors in men than in women. Compounding~     men's risk, men are less likely than women to seek help and to disclose depressive symptoms~     and often delay help seeking until symptoms become severe. Men are socialized to be~     emotionally stoic and exemplify traditional masculine characteristics such as independence,~     self-reliance and dominance. Men are concerned over the perceived negative judgments from~     family and friends if they access treatment for depression. These gender specific~     experiences along with a limited knowledge base about effective interventions call for~     innovative solutions tailored for men. The proposed study was to evaluate the effectiveness~     of an e-mental health program on reducing the risk of major depression in Canadian working~     men.~   "
21397|NCT02777099|"~     The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC)~     initiates autonomic nervous system response and affects the prognosis in patients with acute~     ischemic stroke.~   "
21398|NCT02777086|"~     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is~     to develop and test a self-administered tablet computer app, StaySafe, for probationers~     under community supervision that is designed to improve decision-making skills around health~     risk behaviors, especially involving HIV and hepatitis B & C risks. StaySafe utilizes~     materials and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to~     increase positive decision-making skills for offenders in the last phase of their~     prison-based substance abuse treatment before transitioning back to the community.~   "
21399|NCT02777073|"~     1. To compare levels of ketone bodies (beta-hydroxybutyrate and acetoacetate) in plasma~          and urine following a single dose treatment of either liraglutide 1.8mg,dapagliflozin~          10mg or placebo in insulinopenic state.~        2. To compare plasma levels of free fatty acid, glucagon, hs-CRP, Il-6 and IL-1 before and~          after administration of liraglutide/Dapagliflozin/placebo.~   "
21400|NCT02777060|"~     Explore the benefit of the game-based virtual reality system in improving lower extremity~     kinematics and balance in patients suffering from disease/disorders including Diabetes,~     Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain~     Injury, Stroke or Frailty. A four to six weeks of training with 2 training session/week will~     be provided.~   "
21401|NCT02777047|"~     Oral anticoagulants (warfarin, dabigatran, rivaroxaban and apixaban) are the very top cause~     of serious drug-related harm. More than 7 million prescriptions are dispensed annually for~     oral anticoagulants (OAC) in Canada, with more than 340,000 recipients in Ontario Drug~     Benefit Program alone. Because of their very high and chronic utilization, their large~     benefit in lowering important clinical events (stroke, embolism, death) and their high~     potential for major harm (primarily bleeds, which can be fatal), OACs are the highest~     priority for improving medication safe and effective use. The early period after hospital~     discharge is clearly high risk, with three times the usual rate of major bleeds compared~     with later. Since healthcare has been declared unsustainable in its current delivery form,~     it is time that Hamilton hospitals took the lead in finding more cost-effective ways to~     improve anticoagulation safety. The investigators will do this by structuring discharge~     medication assessment, with formal handover to telehealth coordination and communication~     with patients and their providers, to extend access and reduce the cost of expert~     anticoagulation guidance. This innovative study will rigorously and efficiently address~     whether a focused care coordination intervention targeting the highest priority medication~     safety topic (anticoagulants), delivered by telehealth experts already providing other~     services for Ministries of Health, can improve outcomes and reduce costs of care. The~     rigorous research design tests whether high quality, easily scalable, teletriage~     coordination can be effective in preventing anticoagulation-related adverse events during~     the most risky time period of therapy - transition from hospital to home.~   "
21402|NCT02777034|"~     Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a~     traditional recovery pathway after ileocolon resection for Crohn's Disease.~   "
21431|NCT02776657|"~     This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood~     clots can be identified within the blood vessels supplying blood to the heart in patients~     with angina and who have recently suffered a heart attack.~   "
21403|NCT02777021|"~     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy~     regimens that result in periods of profound neutropenia leaving patients susceptible to~     severe infectious complications. Infectious complications are the leading cause of treatment~     related mortality among AML patients, but there are little clinical data to inform whether~     management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient~     setting. Further, no studies have been conducted that assess the impact of neutropenia~     management strategy on the quality of life of pediatric patients with AML and their~     caregivers.~   "
21404|NCT02777008|"~     Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.~   "
21405|NCT02776995|"~     This research aims to investigate the correlation between tumor temperature difference and~     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.~      In addition, normal tissue response to adjuvant radiation therapy in treated organs~     following surgery, will be evaluated.~   "
21406|NCT02776982|"~     This study is being done to help understand why some people with an increased amount of~     central obesity, without gastroesophageal reflux, develop changes to the lining of their~     esophagus that can potentially lead to esophageal adenocarcinoma (cancer).~   "
21407|NCT02776969|"~     The aim of this project is to identify genetic risk factors associated with familial~     papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows~     high heritability. However, the specific genetic factors that cause an increased risk have~     been elusive.~   "
21408|NCT02776956|"~     A total of 120 patients with persistent atrial fibrillation (including continuous and~     long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial~     fibrillation will receive radiofrequency ablation. Patients in each group will be randomly~     allocated into the statin treatment group and non-statin treatment group (allocation ratio,~     1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal~     Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of~     left atrial function are carried out for all patients before the operation and after the~     operation. Blood samples are extracted in all patients before the operation and after the~     operation. This study will clarify whether the application of statin drugs can improve~     postoperative left atrial function. This study will identify the time course and influence~     factors of left atrial recovery of atrial fibrillation after the operation to guide the time~     and the degree of anticoagulation and effectively prevent thromboembolic events. At the same~     time, biochemical indicators are detected to analyze which indicators are related to the~     postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis~     and the recovery of postoperative left atrial function. Furthermore, this study will~     investigate whether the application of statin drugs can improve postoperative left atrial~     function by affecting these indicators.~   "
21409|NCT02776943|"~     The purpose of this study is to investigate the efficacy and safety of transplantation of~     umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.~   "
21410|NCT02776930|"~     The purpose of this study is to develop algorithms that will help predict future injury~     and/or re-injury after being returned to duty from a musculoskeletal injury. After~     completion of an episode of care with a physical therapist, the subjects will undergo a~     battery of physical performance tests and fill out associated surveys. The subjects will~     then be followed for a year to identify the occurrence/re-occurence of any injuries. Based~     on the performance on the physical evaluation tests, algorithms will be derived using~     regression analysis to predict injury.~      Subjects will be recruited from the pool of patients that have recently completed physical~     rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic~     spine injury.~   "
21411|NCT02776917|"~     The purpose of the study is to investigate the safety of the investigational drug called~     cirmtuzumab in combination with the breast cancer drug paclitaxel. Cirmtuzumab is a type of~     drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1~     that is on the surface of breast cancer cells. This blocks growth and survival of the breast~     cancer cells. ROR1 is rarely expressed on healthy cells so this drug should target the~     cancer cells. Cirmtuzumab is considered experimental because its use is not approved by~     United States (U.S.) Food and Drug Administration (FDA).~      Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease~     the number of breast cancer cells, we do not know if this will work in humans. This drug has~     been tested in humans before, but has never been tested in patients with breast cancer, or~     in combination with paclitaxel in humans. Therefore, the goal of this study is to see if~     cirmtuzumab is safe and tolerable, when in given in combination with paclitaxel in study~     participants. You will be evaluated to find out what effects (good and bad) cirmtuzumab has~     on you and we would like to learn more about how cirmtuzumab might affect the growth of your~     cancer cells. We would also like to see how long the drug stays in your body and what~     affects the drug may have on your body.~   "
21412|NCT02776904|"~     Previous work in the area of concussion management has focused heavily on neuro-cognitive~     testing. In addition to routine neuro-cognitive testing through Immediate Post-Concussion~     Assessment and Cognitive Testing (ImPACT),this pilot study is designed to establish a~     comprehensive battery of clinical assessment through the utilization of functional movement~     and dynamic postural control assessments. The immediate application of these assessments~     will be focused on the male high school football player (who is at risk for concussion). Our~     pilot study aims determine the stability of ImPACT testing in youth athletes in light of~     ongoing neurodevelopment in this population. In addition, this pilot work will implement~     additional tools focused on assessment of dynamic balance, reaction time, and agility. This~     approach will significantly enhance predictions of subsequent musculoskeletal injuries that~     have been shown to occur in concussed collegiate and professional athletes and that we~     believe are also occurring in our high school athletes. This battery of tests will provide~     clinicians with invaluable information to guide both rehabilitation of and return to play~     (RTP) decisions for concussed high school athletes. This pilot study will further track~     those athletes who sustain a concussion and assess increased risks for musculoskeletal~     injury.~   "
21413|NCT02776891|"~     This is a single center imaging study investigating the use of PET with 68Ga-citrate in~     patients with DLBCL or BCLU.~   "
21414|NCT02776878|"~     The purpose of this study is to determine whether dasatinib is effective and safe in the~     treatment of refractory metastatic gastrointestinal stromal tumor~   "
21420|NCT02776800|"~     When elderly patients need help caring for wounds, physicians may refer patients to home~     health care providers. The home health provider sees the patient in the patient's home and~     assists the patient with wound care. Working with the patient's physician, the home health~     provider will use the appropriate wound covering (dressing or bandage) to cover the~     wound. The goal of the home health provider is to ensure that the wound stays clean and~     progresses toward closure. The home health provider will conduct in-home patient visits at~     appropriate intervals to assess the status of the wound.~      Extensive resources are required to see patients in their own homes. If a dressing could~     effectively manage wounds and allow longer time between in-home visits (without affecting~     patient safety or progress of the wound toward closure), then resources could be saved.~     Thus, newer dressings are designed for longer wear times, using advanced foam pads and~     adhesives that help keep the dressing in place. The hypothesis of this study is that the use~     of Allevyn Life will decrease the number of in-home visits by home health providers without~     sacrificing patient safety.~   "
21421|NCT02776787|"~     Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last~     decade, the use of elective colon resection has increased by more than 50%, and~     diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike~     have a difficult time deciding if surgery is the best choice to treat diverticulitis. The~     goal of the DEBUT study is to improve the understanding about how doctors and patients make~     decisions to have elective surgery for diverticulitis, and the global impact of~     diverticulitis on patients' lives.~   "
21422|NCT02776774|"~     There is considerable interest in using in-wound antibiotics (IWA) to prevent infection~     after spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited~     by confounding and bias. This prospective study will enroll spine surgeons across the~     country to complete a survey about their knowledge, attitudes, and practices for using~     in-wound antibiotics.~   "
21423|NCT02776761|"~     This is a single-center, randomized, single-blinded study of the HTNV DNA vaccine alone,~     PUUV DNA vaccine alone, and mixed HTNV/PUUV DNA vaccines delivered IM by the needle-free~     PharmaJet Stratis DSJI device.~   "
21424|NCT02776748|"~     The purpose of this study is to quantify the magnitude and extent of infant exposure to~     daily emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when~     taken pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome~     is the steady state concentrations of emtricitabine and tenofovir in the infant plasma.~   "
21425|NCT02776735|"~     Primary Objective:~      To describe the pharmacokinetic (PK) profile of sarilumab in patients with pcJIA in order to~     identify the dose and regimen for continued development in this population.~      Secondary Objective:~      To describe:~        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients~          with pcJIA.~        -  The long-term safety of sarilumab in patients with pcJIA.~   "
21426|NCT02776722|"~     Despite advances in the prevention and treatment of type 2 diabetes, its prevalence~     continues to rise worldwide. There is a need for new modalities to improve metabolic control~     in individuals with type 2 diabetes and those who are overweight or obese and at risk for~     type 2 diabetes. Contrary to the concerns raised about the adverse role of fructose in~     metabolic health, various lines of evidence suggest that fructose and its epimers may~     improve the metabolic handling of glucose through inducing glycogen synthesis. Recent small~     trials in humans suggest that catalytic doses (=<10g/meal) of fructose and its epimers~     (allulose, tagatose, and sorbose) may reduce postprandial glycemic responses to carbohydrate~     loads (i.e., oral glucose tolerance test or a starch load) in people with and without type 2~     diabetes. There is also limited evidence that these acute effects may manifest as longer~     term improvements in glycemic control. There is an urgent need to synthesize the evidence of~     the effects of fructose and its epimers on postprandial carbohydrate metabolism.~   "
21427|NCT02776709|"~     Cholangioscopy, or direct visualization of the bile ducts was first documented in the late~     1970s and has made many advances over the last few decades. The advent of mother-baby scopes~     allowed for both diagnostic and therapeutic procedures, though the early scopes were often~     fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later~     became popular as a method to digitally view the bile ducts, however, often needed~     guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these~     systems included limited steerability, and poor irrigation capabilities.~      The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a~     fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic~     purposes in the biliary system. However, image quality was often lacking due to the~     fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by~     introducing a digital sensor for better image quality, which will allow for better~     visualization and diagnosis of indeterminate strictures. Furthermore, modification of the~     scope platform allows for efficient use, reliable directionality of the scope tip, and~     improved ease of passage of accessories during therapeutic procedures such clearing stones~     or stent placement.~   "
21428|NCT02776696|"~     The proposed study is two-arms, cross-over, randomized and single-center, in clinic~     Investigation in subjects with type 1 diabetes on insulin pump therapy.~      The purpose of the study is to compare two closed-loop strategies in terms of glycemic~     control in Type 1 Diabetes during a camp setting.~      A total of 20 up to 60 subjects will be enrolled . Subjects will be randomized to~     participate in two periods of closed-loop treatment, each period will last 3-5 days in a~     camp setting. In one period glycemic control will be controlled by the Hybrid Closed-Loop~     System (HCL) and another period by Hybrid Logic Closed-Loop System (HLCL). The sequence of~     treatments with first period HCL therapy than HLCL or vice versa will be randomly assigned.~   "
21429|NCT02776683|"~     The objective of this trial is to evaluate the safety and tolerability of BI 695502 in~     combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy~     (when applicable). As well as to evaluate the following efficacy parameters:~     Progression-free survival (PFS), objective response rate (proportion of patients with~     complete response [CR] plus partial response [PR]), overall survival (OS), duration of~     response (DOR), time to progression (TTP).~   "
21430|NCT02776670|"~     The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE~     compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.~   "
21434|NCT02776618|"~     We will be recruiting patients requiring excisions of skin cancer and comparing aesthetic~     and functional differences of suture repair of excisional defects using polyglactin 910 vs~     poliglecaprone 25 with a split-scar model. Excision sites will be on either the trunk or~     extremities. Standard dermatological excision and repair methods will be used for removal of~     lesions and repair of the wound by surgeons; training courses will be used to limit~     inter-surgeon variation in technique. Excisional defects will be repaired with deep~     polyglactin 910 sutures, followed by randomly assigned subcuticular closure of one half of~     the defect with polyglactin 910 sutures and the other half with poliglecaprone 25 sutures.~     The patient will follow-up at 6 months and fill out a patient self-assessment evaluation~     survey of the scar. Photographs will also be taken of the scars at the follow-up at 6~     months, which will be then be assigned to a set of blinded observers to evaluate the wound~     using a modified Patient Observer Self-Assessment Scale (mPOSAS). These observers will rate~     each scar on the mPOSAS scale and values will be averaged between observers. Total duration~     of participation will be 6 months, with 2 total visits (excision visit and follow-up visit).~   "
21435|NCT02776605|"~     Evaluate the response (complete hematologic response [CHR], complete cytogenetic response~     [CCyR], major molecular response [MMR] and complete molecular response [CMR] of the~     combination of ponatinib with standard chemotherapy (according to PETHEMA ALL Ph08 trial) in~     young patients with Ph+ (BCR-ABL) ALL.~      All patients are treated with:~      Pre-phase (maximum 7 days, -7 to -1):~      Prednisone 60 mg/m2/day IV over 7 days (-7 a -1) and triple intrathecal therapy (TIT)~     (Methotrexate [MTX]: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg). 2. Induction (day 1 to day~     28 or up to hematological recovery) Vincristine (VCR): 1.5 mg/m2 (maximum 2 mg) IV days 1,~     8, 15 and 22. Daunorubicin (DNR): 45 mg/m2 IV days 1, 8, 15 and 22. Prednisone (PDN): 60~     mg/m2/day, IV or PO, days 1 to 27. Ponatinib 30 mg, PO from day 1 to consolidation. TIT,~     days 1 and 22. 3. Consolidation (day 1 to day 63) Mercaptopurine (MP): 50 mg/m2, PO days 1~     to 7, 28 to 35 and 56 to 63. MTX: 1,5 g/m2, IV (24 h continuous infusion) days 1, 28 and 56.~     VP-16: 100 mg/m2/12 h, IV, days 14 and 42. ARA-C: 1000 mg/m2/12 h, IV, days 14-15 and 42-43.~     TIT (MTX: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg), , days 1, 28 and 56. Ponatinib 30~     mg/d PO, from day 1 to 15 days before HSCT. 4. HSCT (performed ideally within 1 month from~     the end of consolidation). AlloHSCT preferred over autoHSCT (autoHSCT only indicated if~     alloHSCT not feasible). Myeloablative conditioning with cyclophosphamide and total body~     irradiation (TBI) whenever possible. 5. Post HSCT therapy After alloHSCT. Frequent~     monitoring of MRD (every month). I After autoHSCT: Frequent monitoring of MRD (every month).~   "
21436|NCT02776592|"~     This study aims to determine if a cow's milk-based formula with added nutrients has an~     effect on memory, reaction time, strategy or other cognitive development indicators in~     children 4-5 years of age.~   "
21437|NCT02776579|"~     The majority of today's youth do not engage in enough physical activity (PA) to maintain~     good health. Low PA levels are associated with poor health (e.g. diabetes, high blood~     pressure) and early mortality. Girls are less likely than boys to be active, and their rates~     of participation drop off more steeply during adolescence. Girls report many barriers to~     exercise, including transportation issues and feeling self-conscious about their appearance~     and abilities. School-based PA programs that try to improve health, mainly through aerobic~     exercise and education, have had a small effect to date. However, the few programs that~     included resistance training as the focus showed strong improvements in health related~     measures. In this project, we will examine the effect of a female strength and conditioning~     specialist on decreasing barriers and increasing the overall health of high school girls,~     with the delivery of in-school, girls-only resistance training programs. We will see if~     physical and mental health changes with the training, and how the presence of the S & C~     specialist affects the girls' social interactions within the school. The results will help~     individuals in the education sector plan programs and services to improve overall youth and~     school health.~   "
21438|NCT02776566|"~     The purpose of this study is to demonstrate the feasibility and effectiveness of~     anticoagulation self-monitoring coupled with an educational intervention in a minority~     underserved population.~   "
21439|NCT02776553|"~     The primary aim of this study is to improve both physical fitness and sarcopenia of patients~     with ESLD who are potentially eligible for liver transplantation through a 16-week physical~     training program. Secondary aims will focus on changes in anthropometrics, body composition,~     quality of life, and metabolic profile. This is a randomized clinical trial including 50~     patients, with half allocated to the active group (physical training program) and half to~     standard of care.~   "
21440|NCT02776540|"~     Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological~     outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or~     intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.~   "
21441|NCT02776527|"~     The main purpose of this study is to evaluate whether the Apatinib can improve the disease~     free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed~     postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether~     the Apatinib can improve the overall survival (OS), estimate the quality of life of patients~     have taken the Apatinib and monitor the security of Apatinib.~   "
21442|NCT02776514|"~     This study investigates clinical outcome and imaging outcome parameters after intraarticular~     injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients~     with early osteoarthritis of the knee joint.~   "
21443|NCT02776501|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
21444|NCT02776488|"~     Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function~     as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed~     safety analysis of glucose and sodium lactate infusions in humans and have demonstrated~     proof of concept that these fuels alter brain metabolism. We will conduct a multicenter,~     adaptive design-based, proof of concept unblinded phase 2 study of up to 3 candidate~     supplemental fuels infused over 3 hours in patients with severe traumatic brain injury~     undergoing standard of care multimodality monitoring with cerebral microdialysis.~   "
21445|NCT02776475|"~     This prospective one group cohort study seeks to investigate the effects of sacral~     neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the~     simulator device is temporarily turned off for a period of four weeks.~   "
21448|NCT02776436|"~     The manufacturer recommends two different regimens of prophylactic dexamethasone to prevent~     hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of~     dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for~     prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the~     concurrent use of prednisone 2dd5mg. There is little evidence that supports this high dose~     regimen used nowadays. There is need to re-evaluate this high dosage of dexamethasone for~     three main reasons. First, dexamethasone can give side effects such as manifestation of~     latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or~     mania and mood swings. Second, dexamethasone is an immune suppressor, which might inhibit~     chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents.~     Third, dexamethasone is a CYP3A4 inducer, which might increase docetaxel clearance. This~     study aims to evaluate the feasibility of reducing prophylactic of dexamethasone around~     docetaxel infusion.~   "
21449|NCT02776423|"~     Transurethral injection using polyacrylamide hydrogel (Bulkamid®, Contura A/S, Denmark) is~     an established treatment for stress urinary incontinence. The rates of women reporting~     improvement or cure after Bulkamid injection for stress urinary incontinence range between~     64-77% with a very low morbidity. However, the indications for use are unclear. Although~     transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with~     regard to expected cure rates, the procedure is associated with very low rates of adverse~     events in general and serious adverse event in particular. As such, it may be an important~     alternative for patients where surgery is not considered a safe option either because of~     co-morbidity or because of complicated incontinence. The investigators performed a~     prospective study to determine the effects of transurethral polyacrylamide hydrogel~     injection in patients considered ineligible for midurethral sling surgery.~   "
21450|NCT02776410|"~     The purpose is to investigate young consumers' attitudes and behaviour towards sustainable~     and healthy eating by applying a multidisciplinary approach, taking into account economical,~     marketing, public health and environmental related issues. In order to achieve this goal,~     consumers' reactions on interactive tailored informational messages about sustainable from~     social, environmental and economical point of view, as well as healthy eating behaviour in a~     group of Polish young adults will be investigated. Main research questions that will be~     addressed: What is consumer's current behaviour and perception of sustainable healthy~     eating? What are factors determining consumers' reactions to messages about sustainable~     healthy eating? What are consumers' reactions on interactive tailored communication about~     sustainable and healthy eating behaviour? About 200 Polish consumers will take part in this~     randomized controlled trial. A stratified design will be used to recruit 18-30 years old~     adults using smart phones. The sample will be represented for gender and region.~     Participants will be randomly assigned to either a study or a control group. They will~     complete a baseline and follow-up survey. An application for smart phones will be developed~     by a professional IT company in order to deliver personalised messages to the participants.~     Intervention will take one month. Messages developed following the theory-linked definitions~     of behaviour change techniques will be sent to the participants every 2-3 days. The six~     principles of sustainable and healthy behaviour introduced in the campaign Livewell 2020~     will be used as a base to communicate to consumers.~   "
21451|NCT02776397|"~     Relationship of haptoglobin phenotype to vascular function and response to Vitamin E~     supplementation in Patients with Diabetes Mellitus Type 2: The EVAS Trial~      Specific Aims:~      The phenotype haptoglobin 2-2 (Hp 2-2) is associated with higher oxidative stress,~     inflammation, LDL peroxidation and higher cardiovascular risk in patients with diabetes. We~     aim to determine whether Hp 2-2 phenotype is associated with surrogate markers of~     cardiovascular risk, inflammation, lipids and lipoprotein profile, oxidative stress, and~     endothelial cell (EC) apoptosis (in vitro study) in patients with diabetes in our population~     and whether vitamin E supplementation mitigates this risk.~      Methods:~      Screening Phase:~      We will recruit 300 patients with diabetes mellitus type 2 (100 Chinese, 100 Malays and 100~     Indians) and assess their Hp phenotype, surrogate markers of cardiovascular risk,~     inflammation, vascular biomarkers and lipids phenotype.~      In vitro Study:~      Plasma from 20 patients with Hp 2-2 phenotype and 20 patients with non Hp 2-2 phenotype will~     be studied in vitro using a haemodynamic lab-on-chip system to determine whether there is a~     difference in EC apoptosis between the two groups.~      Randomisation Phase 200 patients will be recruited to a pilot randomized controlled trial~     (RCT), stratified by Hp 2-2 phenotype status (100 Hp 2-2 and 100 non-Hp 2-2), and randomly~     allocated in a 1:1 ratio to either vitamin E 400 IU supplementation daily for 6 months or a~     placebo group. The trial will determine whether vitamin E improves the aforementioned~     surrogate markers in the Hp phenotype strata.~      Importance of proposed research to science and medicine:~      This study allows us to understand the possible mechanism of cardiovascular risk in patients~     with Hp 2-2 phenotype and to see whether vitamin E supplementation reduces this risk in a~     pharmacogenomic targeted manner.~   "
21452|NCT02776384|"~     The study aims to investigate whether disease progression in patients with chronic heart~     failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The~     study also intends to describe comparison of echocardiography with cardiopulmonary function~     test in CHF patients, and relating these cardiac functional parameters to clinical outcome.~   "
21453|NCT02776371|"~     Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1),~     especially 47-66% in China.~   "
21454|NCT02776358|"~     Bedside clinical case learning, such for respiratory distress, represent a challenge for~     medical teachers, especially in critical conditions. In fact, this kind of learning~     implicate the presence of an appropriate case (the patient itself), framework and may be~     time consuming which could compromise the patient's safety and wellbeing.~      New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of~     knowledge. in recent years, the development of medical simulation has found a growing~     interest in the medical teaching field. Contextualization, reproducibility and reliability~     are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime~     experience of clinical conditions without putting at risk patient's safety and comfort.~      The aim of this study is to assess the impact of HFS on fifth year medical students learning~     skills in the assessement and management of an acute asthma attack in the emergency room,~     and to compares it to other modern teaching tools such as video-case~   "
21455|NCT02776345|"~     The purpose of this study is to determine whether minimally invasive treatments like~     ultrasound guided needle fragmentation with and without lavage is associated with better~     clinical outcomes compared to the subacromial bursal corticosteroid injection treatment~     only.~   "
21456|NCT02776332|"~     The purpose of this study is to determine how the duration of manual expression affects milk~     volumes and levels of breastfeeding self-efficacy in mothers of premature infants.~      The specific aims of this study are to determine if the duration of manual expression in~     mothers of premature infants will result in: (a) an increase in breastfeeding self-efficacy~     (b) a difference in milk volume and (c) a correlation between breastfeeding self-efficacy~     and milk volume.~   "
21459|NCT02776293|"~     Prenatal anxiety and depression are distressing for the expectant mother and can have~     adverse effects on her fetus and child. This study aimed to determine whether listening to~     specially composed songs would be an effective intervention for reducing symptoms of~     prenatal anxiety and depression over a period of 12 weeks.~   "
21460|NCT02776280|"~     This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and~     solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared~     with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian~     meals (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or~     non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of~     food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion,~     unstimulated saliva and dental biofilm will be collected for determination of fluoride~     concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of~     mastication) will be collected for determination of fluoride concentration. Dental biofilm~     will be collected immediately after the ingestion of the meal. Saliva will then be collected~     after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an~     ion-specific electrode. In order to standardize biofilm formation, during lead-in and~     wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2.~     refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew~     sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each~     phase. Groups will be compared by ANOVA and Tukey test.~   "
21461|NCT02776267|"~     The purpose of this study is to perform a first-in-man assessment of feasibility,~     exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent~     (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).~   "
21462|NCT02776254|"~     This study seeks to create generalizable knowledge about the implementation process as well~     as the effectiveness and efficiency of a differentiated care system, by measuring patient~     health outcomes and implementation outcomes such as acceptability, feasibility, fidelity,~     and costs~   "
21463|NCT02776241|"~     The objective of this study is to measure the influence of both short term water restriction~     and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI)~     scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.~   "
21464|NCT02776228|"~     The study deals with the prevalence of insomnia after heart surgery and the outcome of~     treatment with Benzodiazepine for this phenomena.~   "
21465|NCT02776215|"~     Open-label, single-dose, non-controlled trial to evaluate the pharmacokinetics and safety of~     tasimelteon in children from 3 years to less than 18 years of age who are totally blind with~     no conscious light perception and have Non-24-Hour Sleep-Wake Disorder.~   "
21466|NCT02776202|"~     Sickle cell disease (SCD) is the most common inherited blood disorder in Saudi Arabia . Its~     clinical severity is widely heterogeneous among patients who share the same genetic mutation~     . Severe frequent pain crisis, recurrent acute chest syndrome and stroke are features of~     severe SCD. Hydroxyurea is an effective treatment of SCD as it ameliorates the severity and~     frequency of pain crisis and acute chest syndrome and decreases mortality, however, it is~     less effective in the prevention and treatment of stroke and other end organ dysfunctions .~     The only readily available cure of SCD is by hematopoietic stem cell transplantation (HSCT)~     . Most children with SCD who are treated by HSCT receive myeloablative conditioning with~     excellent results. The application of reduced intensity (RIC) and non-myeloablative (NMA)~     conditioning regimens are reserved for patients older than 16 years of age because of the~     increased risks of morbidity and mortality after HSCT6. However, infertility and gonadal~     failure after myeloablative conditioning are important barriers to the willingness of~     patients and their families to undergo HSCT . The development of an effective RIC HSCT in~     SCD that might spare the fertility of SCD patients would have obvious merit.~      With the ultimate goal of expanding this curative therapy to SCD patients, we propose to~     investigate HSCT with a RIC conditioning regimen. We will carry out a pilot study of HSCT~     from HLA matched sibling donors using thymoglobulin/fludarabine/melphalan conditioning and~     sirolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis in SCD patients with severe~     complications such as stroke and other severe complications. We hypothesize that HSCT from~     HLA matched sibling using thymoglobulin/fludarabine/melphalan conditioning in SCD will~     maintain a level of stable donor chimerism that is sufficient to cure SCD with minimal~     toxicity.~   "
21467|NCT02776189|"~     MRI though not painful requires deep sedation for children due to the loud noise created.~     With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For~     standardization MRI brain was chosen and also for the fact that patients usually have~     history of convulsions where drugs like ketamine may not be a good option. Patients were~     recruited after ethics committee approval. After pre-medication with intranasal midazolam~     0.2 mg/kg body weight, Intravenous access was established and then patients were divided in~     two groups. One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg~     body weight per minute. The other group received intravenous bolus of Dexmedetomidine~     1mcg/kg over 10 minutes and then a infusion of Dexmedetomidine 1mcg/kg/hour.~      Primary out come was to study the recovery time of patients sedated with Dexmedetomidine~     compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were~     analysed in terms of time for induction,procedural disruptions due to awakening and~     haemodynamic stability . Follow up was done on phone for any adverse events.~   "
21468|NCT02776176|"~     The study is designed to determine if enhanced recovery after surgery (ERAS) principles~     could provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's~     Disease (HD). Half of patients will receive the ERAS program, while the other half will~     receive the traditional program.~   "
21469|NCT02776163|"~     This is a non-randomized, phase II, open label study of postoperative current~     chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary~     purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy~     in these patients.~   "
21479|NCT02776033|"~     This is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase~     inhibitor, in subjects with active plaque-type psoriasis.~      The primary objective will be to investigate the safety and tolerability of repeat oral~     doses of GSK2982772 (60 mg twice daily for 84 days). In addition a number of experimental~     and clinical endpoints will be employed to obtain information on the pharmacokinetics,~     pharmacodynamics, and efficacy in subjects with active plaque-type psoriasis (PsO).~      After a screening period of up to 30 days, approximately 30 subjects will be randomized to~     receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a follow-up period~     (28 days). The total duration of this study is approximately 20 weeks from screening to the~     last study visit.~   "
21480|NCT02776020|"~     The aim of this study is to determine efficacy of the CorrecDose device to continuously~     and non-invasively follow the changes in propofol concentrations in the participants' blood.~   "
21470|NCT02776150|"~     Background:~      Drug resistant tuberculosis is a serious public health problem that threatens the health of~     human life and the development of society and economy. At present, the diagnosis of~     drug-resistant tuberculosis mainly depends on traditional drug susceptibility test. But it~     is limited in Mycobacterium tuberculosis slow growth speed, traditional solid drug~     sensitivity test usually need to 3 months to results, delay the development of drug~     resistance in patients with effective treatment. Probe melting curves resistance detection~     technology is the recent emergence of a new molecular biology and drug resistant~     tuberculosis detection technology, probe melting curves with different fluorescent labeled~     probe coverage detection specific to M.tuberculosis drug resistance determining region,~     through changes in the melting point of the probe hybridization, acquire mutation~     information of detection region, shorten detection time and detect nonuniform resistance.~      In this study, by selecting a nationally representative in different levels of hospitals~     jointly launched multi center, large sample clinical assessment, completed the comprehensive~     evaluation of sensitivity, specificity and health economics of drug resistant pulmonary~     tuberculosis, especially resistance to multidrug and extensively drug-resistant TB patients~     detection,in order to evaluate the rapid, accurate and economic and appropriate technology~     of drug resistance pulmonary tuberculosis detection.~      In order to accomplish the overall goal of the project, in the framework of the overall~     design, according to the principles of the core tasks are divided into four sub topics,~     namely:~      Sub topic 1 of the core mission is included in 3100 cases of smear positive pulmonary TB~     suspicious symptoms, from which selected more than 1000 cases of drug-resistant pulmonary~     tuberculosis patients, using MGIT liquid culture and drug sensitivity test as the gold~     standard,evaluate the sensitivity and specificity of probe melting curves in detction of~     resistance of four kinds of anti tuberculosis drug to Mycobacterium tuberculosis; Sub topic~     2 core task is including at least 500 cases of culture positive pulmonary tuberculosis~     patients and treatment follow-up, using MGIT liquid culture and drug sensitivity test as the~     gold standard, evaluate the application value of probe melting curves for monitoring~     spectrum changes of drug resistance of Mycobacterium tuberculosis during pulmonary~     tuberculosis treatment.~      The core mission of sub topic 3 is to project implementation of hospital as the research~     site,acquire the cost-effect evaluation and analysis by comparing probe melting technology~     with Mycobacterium tuberculosis MGIT liquid culture, and drug sensitivity test with xpert~     MTB/RIF technology.~   "
21471|NCT02776137|"~     This is a non-randomized, phase II, open label study of postoperative concurrent~     chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and~     neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of~     concurrent chemoradiotherapy with docetaxel in HNSCC patients.~   "
21472|NCT02776124|"~     Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients~     undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other~     treatment-related problems. Malnutrition is associated with lower physical functioning,~     lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment~     interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital~     readmission, impaired quality of life (QoL), and increased mortality. Although the~     international guidelines recommend early nutritional support in the presence of nutritional~     risk, the best type of nutritional intervention is still unclear. Individualized dietary~     counseling showed beneficial effects in nutritional intake, nutritional status and QoL in~     head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements~     (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials~     in head-neck cancer patients have been conducted on small samples and did not clarify the~     role of oral nutritional supplements (ONS). Accordingly, although current guidelines~     recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer~     patients undergoing RT, the efficacy of this nutritional intervention still needs to be~     evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.~   "
21473|NCT02776111|"~     The field of genomics is an exciting new field being applied in medicine. Its use in~     treating some cancers, sepsis and burn patients has been very promising. As knowledge of~     genomics and application of microarrays expands, researchers are developing more intelligent~     ways to provide individualized care for patients. The plan of this research study is to~     apply the use of genomics as a tool for transplant in several capacities.~      This research study is designed to develop methods of isolating relevant cell types via~     microarray plates, then extracting mRNA samples of those cell types and capturing their~     genetic profile. This will be done with the blood of five healthy donors. Once this ability~     has been demonstrated, the next step will be to use these testing in several capacities in~     transplant patients. The research study plan involves following the genetic profile of 26~     kidney transplant patients. One group will be followed prospectively starting at baseline,~     and then at various set time points. A second group will be sampled with the occurrence of~     clinical events. These events include viral, bacterial, and fungal infection, WBC < 2.5 or~     biopsy proven rejection episodes or normal graft function. Thus, the intention of the study~     is to demonstrate how immunosuppression alters the expression of this genetic expression of~     these T cells. In doing so, the study will provide a better understanding of the specific~     and true immunosuppressed state for any given patient.~   "
21474|NCT02776098|"~     This study will investigate the link between glucose abnormalities and elements critical to~     muscle function including mass, composition and energy metabolism. the primary goal of the~     study is to determine whether Cystic Fibrosis (CF) disease is associated with muscle~     dysfunction, especially in the presence of glucose intolerance. This is a longitudinal~     cohort study of 3 main groups: CF subjects without Cystic Fibrosis-related diabetes (CFRD),~     healthy matched controls and CF subjects with newly diagnosed CFRD started on insulin~     therapy.~   "
21475|NCT02776085|"~     Bedside ultrasound in the emergency department is useful for quick assessments of patients.~     One growing use is to measure the optic nerve sheath diameter of patients for whom increased~     pressure in the head is a concern. This study will look at the optic nerve sheath diameters~     of a specific population of pediatric patients with shunts that drain extra fluid from their~     heads.~   "
21476|NCT02776072|"~     The primary objective of the study is to evaluate the real-world clinical effectiveness, as~     measured by the proportion of participants relapsed at 12 months, in participants treated~     with dimethyl fumarate (DMF).~      Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as~     measured by the proportion of participants relapsed at 12 months, in participants treated~     with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall~     participant cohort and in a subset of participants who were naïve to disease-modifying~     therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the~     index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among~     participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related~     hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To~     compare intravenous corticosteroid use among participants treated with DMF, GA,~     teriflunomide, or fingolimod.~   "
21477|NCT02776059|"~     This is a multi-center, prospective, randomized trial of standard of care vs. standard of~     care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic~     hepatitis and DF≥32.~   "
21478|NCT02776046|"~     The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a~     perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.~   "
21481|NCT02776007|"~     The Libre- flash glucose monitoring system is an episodic real-time data on demand device.~     This means that patients can measure their glucose level when they choose by scanning the~     device, while at the same time a sensor automatically measures and continuously stores~     glucose readings day and night. Every scan shows the current glucose reading and the last 8~     hours of glucose. There are no alarms and the system does not require calibration.~      In the present study we aim to evaluate treatment satisfaction and comfort using the Libre~     flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose~     (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose~     monitoring.~      The second aim of the study is to evaluate the rate of use and the impact of Libre use~     compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally~     controlled and stopped using Continuous Glucose Monitoring. The study is an investigator~     initiated study, single-center, randomized, parallel study of 12 weeks with an optional~     cross-over 12 weeks extension period .~   "
21482|NCT02775994|"~     Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis (PFAPA) is one of the~     most common, least explored periodic fever syndrome in childhood. This study aims to~     investigate whether a single dose of an interleukin beta (IL-1) antagonist, Canakinumab will~     be able to abort PFAPA flares in patients who experience a flare in an average of 2 weeks or~     less. This will be a single arm open label pilot study. 10 patients will be recruited from 1~     center (Pediatric rheumatology unit -Schneider children's medical center of Israel).~      Patients in ages 2-10 years old who are diagnosed with PFAPA according to clinical criteria~     at least 3 months prior to enrollment and who are under regular care for this disease~     (single dose of glucocorticoids during flare) and who suffer from more than 4 PFAPA flares~     for the last 2 months, will be screened for this study. In the second documented flare,~     patients will be enrolled to receive a single dose of subcutaneous (SC) Canakinumab 4 mg/kg.~     The primary outcome is defined as - 50% reduction in PFAPA flares for the next 2 consecutive~     months as reported by the patient (use of diary) and documented by the patient primary care~     physician and/ or the researcher in a monthly follow up visits. Secondary outcome measure~     are define as time to flare (days) and Parent/patient quality of life assessment measured by~     100mm visual analog scale (VAS).~   "
21483|NCT02775981|"~     The primary objective of this study is to evaluate the potential effect of hepatic~     impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal~     administration. The secondary objective is to evaluate the safety and tolerability of~     intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.~   "
21484|NCT02775968|"~     This study is based on the hypothesis that the pharmacokinetics of antibiotics in children~     is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for~     children with community acquired pneumonia, the investigators aim to study the population~     pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug~     for treatment of community acquired pneumonia, and to correlate it with treatment~     effectiveness and incidence of adverse effects.~      Potential Impact: This novel knowledge will allow better and more rational approaches to the~     treatment of community acquired pneumonia. It will also set the foundation for further~     studies that will be able to test improved therapies that may increase treatment response in~     vulnerable children.~   "
21485|NCT02775955|"~     The primary objective of this study is to evaluate the potential effect of renal impairment~     on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is~     to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with~     normal renal function and severe renal impairment.~   "
21486|NCT02775942|"~     A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC-~     POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in~     Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two~     hundred and forty children are enrolled and placed randomly into 4 groups (60~     children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week~     interval. Safety issues included immediate reaction at the site of injection and systemic~     reaction within 30 min of administration, within 7 days after each dose, unexpected event~     occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood~     cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising~     antibodies for each of vaccine serotypes.~   "
21487|NCT02775929|"~     The purpose of this protocol is to determine user preferences for antiretroviral therapy~     (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected~     partners and to optimize targeted delivery and sustained use of these interventions.~   "
21488|NCT02775916|"~     This Study is designed to evaluate the safety, tolerability, pharmacokinetics and~     preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta~     inhibitor, for 12 weeks, in patients with primary Sjögren's syndrome. Data from this study~     will provide basis for further development of the compound for the treatment of primary~     Sjögren's syndrome.~   "
21489|NCT02775903|"~     This is a Phase 2, multicenter, randomized, parallel-group, open-label study consisting of 3~     phases: Screening, Treatment, and Follow-up.~      To confirm the safety, ie, the absence of overlapping toxicities of the combination~     treatment regimen, an early safety monitoring will be performed based on approximately the~     first 12 subjects randomized.~      A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS)~     cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.~   "
21502|NCT02775734|"~     This prospective randomized placebo-controlled double blind clinical trial will conducted in~     Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene~     citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will~     be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC~     1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or~     clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical~     pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live~     birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation,~     mid- luteal sub-endometrial blood flow indices, and incidence of side effects.~   "
21814|NCT02771665|"~     To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer~     recurrence and survival outcome in patients with invasive breast cancer after surgery~   "
21490|NCT02775890|"~     This is a clinical research protocol to determine the feasibility of assessing lead levels~     in hunters who use lead projectiles. This study will determine if it is possible to perform~     an interventional double-blind placebo-controlled study of lead levels in hunters using lead~     or lead-free projectiles following consumption of self-harvested wild game. The hypothesis~     for the subsequent study is that minute lead particles from shrapnel dispersed through the~     animal during harvest are ingested and result in increased lead serum levels. This current~     observational study establishes if this conclusive interventional study is possible through~     establishing if hunters using lead projectiles in New Zealand have elevated lead levels~     after eating animals harvested with lead projectiles. This study will be conducted in~     compliance with the protocol, Good Clinical Practice Standards, associated regulations and~     institutional research requirements.~      This study aims to assess if hunters eating meat shot with lead projectiles experience~     elevated lead levels. Hunters will be asked to provide blood samples 2-4 days after they eat~     meat harvested with lead bullets and provide a subsequent sample when they have abstained~     from eating wild game harvested with lead bullets. We have chosen to use deer as the species~     for this study to reduce variation and New Zealand is the ideal place to conduct this study~     because of year-round hunting of deer. This design will allows paired testing of subject~     lead levels.~   "
21491|NCT02775877|"~     The purpose of this study is to study the effects of letrozole and sequential clomiphene in~     ovulation and pregnancy in PCOS patients.~   "
21492|NCT02775864|"~     The study is a retrospective cohort study of adults with schizophrenia that will compare~     outcomes of new users of alternative psychotropic medication strategies using 10 years of~     Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of~     patients with schizophrenia facing common clinical situations.~   "
21493|NCT02775851|"~     This pilot phase II trial studies how well pembrolizumab works in treating patients with~     desmoplastic melanoma (DM) that can or cannot be removed by surgery. Monoclonal antibodies,~     like pembrolizumab, may block specific proteins which may strengthen the immune system and~     control tumor growth.~   "
21494|NCT02775838|"~     Aim of this clinical study is to establish a novel technique, the so called intraoperative~     fluorescence angiography, for kidney graft perfusion visualization during the transplant~     procedure.~   "
21495|NCT02775825|"~     End-of life care is one of the principle components of cancer care. Measurement of the~     quality of care provided for end-of-life cancer patients is an important issue. Recently~     there has been an increased emphasis on measuring and monitoring the quality of cancer care~     for the purpose of improving clinical practice. Despite increasing attention paid to~     end-of-life care in recent years, many studies have described difficulties in the final~     phase of life, including problems with access to hospice, inadequate symptom management,~     care giving burdens, care mismatched with patient preferences, and inappropriate resource~     use. Measuring quality of life is an important issue for monitoring clinical practice and~     improving outcome. Although patient assessment is the best quality measure, it is~     impractical to measure the quality of end-of-life care because of the difficulties of~     accurate prognostication for end-of-life and many patients are too ill to provide~     assessments. In contrast, several recent studies developed quality indicators (QIs) of~     palliative and end-of-life care, which assess the quality from existing sources such as~     administrative data or medical chart data.~   "
21496|NCT02775812|"~     This phase I trial studies the side effects and best dose of pembrolizumab when given~     together with cisplatin and intensity-modulated radiation therapy, in treating patients with~     stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs~     used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells~     and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation~     therapy may work better in treating patients with squamous cell carcinoma of the head and~     neck.~   "
21497|NCT02775799|"~     Registration of all sarcoma patients treated at a specialized sarcoma center in Switzerland.~   "
21498|NCT02775786|"~     This is a prospective cohort study in participants with pancreatic adenocarcinoma who are~     undergoing surgical resection. Participants will have up to two magnetic resonance imaging~     (MRI) scans with and without intravenous contrast. The MRI will be performed using either an~     extracellular contrast agent or using a macromolecular contrast agent. These contrast agents~     are routinely used in body MRI and are on formulary at this institution. Parameters will be~     compared to histopathology measures of mean vascular density and grade of fibrosis,~     respectively. The purpose is to establish a standard protocol for future clinical trials of~     treatments that would use MRI parameters as quantitative markers of treatment effect.~   "
21499|NCT02775773|"~     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and~     oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post~     partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post~     partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a~     vaginal delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called~     primary when blood loss arose within 24 hours after birth.~   "
21500|NCT02775760|"~     The overall goal of this study is to examine how regular exercise affects brain function,~     spatial memory, and virtual navigation. Participation in this research study will take~     approximately 4 months.~   "
21501|NCT02775747|"~     There is limited application of the use of PRP in obstetrics, therefore there is a need for~     assessment if it is efficacy in improving skin wound healing in cesarean section.~   "
21503|NCT02775721|"~     Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for~     head and neck cancer. Inadequate dietary intake is multi factorial, with patients~     experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard~     practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related~     to Head and Neck cancer treatment.~   "
21504|NCT02775708|"~     The purpose of this study is to support development of PillCam Endoscopy System~     applications.~   "
21508|NCT02775656|"~     The purpose of this observational follow-up study is to collect data systematically on~     pregnancies and offspring of women who become pregnant while participating in a Certolizumab~     Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential~     CZP exposure during pregnancy.~   "
21509|NCT02775643|"~     This is an observational, non-therapeutic study to collect clinical and molecular~     information of pediatric patients with childhood melanocytic lesions.~      PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from~     paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions~     (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant~     nevi).~      SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or~     systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.~   "
21510|NCT02775630|"~     Bronchoscopy is an examination performed routinely in pulmonology. This exam is considered~     as uncomfortable by nearly 60% of patients, especially due to respiratory blocking~     sensation, cough and nausea it causes, despite the use of a local anesthetic. Conversely,~     this examination is rarely performed under general anesthesia in hospitals in France,~     because it lengthens the duration of the procedure, increases its cost and can be dangerous~     for the respiratory failure patient.~      Hypnosis is an altered state of consciousness between wakefulness and sleep, which can cause~     the patient to ignore the reality in which he is focusing his attention on his imagination,~     reducing his anxiety, his painful or unpleasant perceptions and their memorization.~      The hypnosis benefit has already been evaluated in the control of pain and anxiety in many~     medical situations, surgical, obstetric and dental. In endoscopy, the results are mixed. In~     bronchoscopy, hypnosis has, to our knowledge, not been evaluated.~      In a preliminary study in the endoscopy unit of the Hospital Saint Joseph, involving 66~     patients, investigators showed that bronchoscopy was poorly tolerated in more than half of~     patients and that this poor tolerance was correlated to the level anxiety of patients, but~     75% of patients surveyed would prefer the waning redo the examination in the same conditions~     if their health required it, rather than using a general anesthetic. Investigators then~     hypothesized that hypnosis would improve tolerance bronchoscopy under local anesthesia,~     without the need for general anesthesia.~   "
21511|NCT02775617|"~     This is an open-label prospective community intervention trial to assess the impact of~     community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws~     bacterial skin infections.~      Communities will be randomised to receive standard treatment for both yaws and scabies~     either in parallel (site 1) or in sequence (site 2).~      Treatment of yaws:~      Single dose of Azithromycin (30mg/kg, max 2G).~      Treatment of scabies:~      Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a~     contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses~     7-14 days apart.~      Investigators will complete a clinical and microbiological assessment of bacterial skin~     disease at baseline and at 12 months to assess the impact of treatment on the prevalence of~     bacterial infection and the emergence of antimicrobial resistance.~      Primary Outcome~        1. Difference in the change in prevalence of impetigo between baseline and 12- months~          between the parallel and the sequential treatment arms.~           Secondary Outcomes~        2. Change in the proportion of swab samples from which S. pyogenes is cultured between~          baseline and follow-up in the two arms~        3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured~          in the two arms~   "
21512|NCT02775604|"~     The purpose of this study is to assess the feasibility and potential impact of video~     analysis of footage taken with a GoPro camera video in comparison to a homeowner checklist~     or gold standard home assessment as a means of detecting home fall hazards.~      Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera~     will be better than a homeowner paper checklist in hazard identification.~   "
21513|NCT02775591|"~     The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe~     for the treatment on health-related quality of life in Parkinson's disease (PD) patients~     with gastrointestinal symptoms.~   "
21514|NCT02775578|"~     As the end stage of almost all cardiovascular diseases, heart failure has become an~     increasingly common cause of cardiovascular morbidity and mortality worldwide. In China,~     coronary artery disease (CAD) has become the main cause of heart failure in recent years.~     CAD combining with heart failure usually predicts poor outcome, with coronary~     revascularization the most universally used therapy. However, the difference of several~     types of such therapy has less well been compared.~      Thus, the study mainly aims to compare different types of coronary revascularization~     therapies such as Percutaneous Coronary Intervention (PCI),Coronary Artery Bypass Grafting~     (CABG) as well as Hybrid Coronary Revascularization (HCR), and also make the optimization~     strategy especially in patients with heart failure.~      The study also aims to investigate whether disease progression in patients with chronic~     heart failure (CHF) can be assessed by new biomarkers and determine their diagnostic and~     prognostic value, relating several cardiac functional parameters to clinical outcome.~   "
21515|NCT02775565|"~     This is a retrospective, record-based study of approximately 100 patients across up to 12~     centers within the United States. All patients who have been treated with the AngioVac~     Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study~     participation. Eligible subject must meet all of the inclusion criteria and none of the~     exclusion criteria to be considered enrolled in the study. The purpose of the study is to~     describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal~     Circuit.~   "
21516|NCT02775552|"~     Alive & Thrive is an initiative that aims to scale up nutrition to save lives, prevent~     illness, and ensure healthy growth and development through improved infant young child~     feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive &~     Thrive intervention package, consisting of interpersonal communication, community~     mobilization activities, and radio campaign, can increase complementary feeding practices~     (minimum dietary diversity and minimum meal frequency) while sustaining exclusive~     breastfeeding rate among children less than two years of age. The impact evaluation uses a~     cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized~     to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional~     baseline and endline surveys will be used to assess program impact.~   "
21518|NCT02775526|"~     This prospective interventional randomized controlled trial will recruit women with MUI~     scheduled for surgical treatment where patients will be randomized to either Burch~     colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2~     years. The primary outcome measures will be the objective and subjective cure rates.~   "
21519|NCT02775513|"~     Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS)~     due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function~     mutations also exhibit altered hormone release upon glucose ingestion.~   "
21520|NCT02775500|"~     The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and~     unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication~     relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal~     apremilast exposure on infant health status through one year of age.~   "
21521|NCT02775487|"~     Primary objective of this project is to measure the impact of passive control and active~     control systems on indoor pollution that is directly or indirectly related to ambient air~     pollution (smog). The first goal will be to measure baseline parameters for 50 homes,~     including information about the building, ventilation characteristics, pollution levels~     (indoors and outdoors), and occupant survey information. In a subset of these homes, either~     passive or active control systems will be installed and the impact of these systems on~     indoor concentrations. Participants will be enrolled on a rolling basis (5-15 persons~     studied at a given point in time) over a 16-month period. Participants will be followed for~     approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of~     study), after 1 week (baseline verification) and after four weeks with the control system in~     the home (at the end of study week 5).~   "
21522|NCT02775474|"~     The recent increase in obesity has led to an increase in the need for bariatric surgery. In~     this group of patients the postoperative pain management is of vital importance. One~     strategy to improve postoperative analgesia is the use of intraoperative methadone,~     specially in those patients which regional anesthesia is not feasible. There is evidence~     that the use of intraoperative methadone can lead to a analgesia lasting 24 to 36 hours,~     while not associated with increased side effects when compared to other opioids with short~     or intermediate duration of action. In this study the investigators will evaluate the~     efficacy of intraoperative methadone in reducing postoperative pain and opioid consumption.~   "
21523|NCT02775461|"~     The purpose of this study is to establish a registry of patients with pancreatic diseases.~     Patients included in the registry may include those with: pancreatic cancer, precancerous~     lesions of the pancreas, inflammatory lesions of the pancreas, cystic lesions of the~     pancreas, and patients at high-risk of pancreatic cancer such as those with a family history~     of pancreatic cancer or with a family history of a syndrome known to be associated with~     pancreatic cancer. Pancreatic cancer is the fourth leading cause of death from cancer in the~     United States. However, little is known about the development of pancreatic cancer and~     pancreatic diseases in individuals with the above conditions. Knowledge of how family~     history, environmental exposures, and inflammatory lesion of the pancreas contribute to the~     development of pancreatic cancer and pancreatic diseases is essential.~      You may qualify to take part in this research study because you have inflammation in the~     pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a~     family history of pancreatic cancer, or a family history of a syndrome known to be~     associated with pancreatic cancer.~      We will also be collecting a blood sample from all participants for DNA isolation. Sometimes~     we are born with genes or DNA that give us an increased or decreased chance of developing an~     illness later in life. Genetic material will be isolated from your blood for further study.~     You may also choose to provide additional blood samples for serum and plasma extraction.~     Serum and plasma are components of the blood which can be used to measure indicators of~     disease in the blood, called biomarkers,for pancreatic diseases. Clinical data and~     biological specimens contained in this study may be used for a wide variety of future~     related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer.~      Funds for conducting this research are provided by Mount Sinai.~   "
21524|NCT02775448|"~     Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in~     climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been~     used for hepatic diseases. It has been used for reducing hypercholesterolemia and~     hypertriglyceridemia also. The aim of this study is to investigate the most effective dose~     of Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise~     for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.~   "
21525|NCT02775435|"~     This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel~     (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first~     line metastatic squamous non-small cell lung cancer (NSCLC).~      The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free~     Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as~     assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival~     (OS).~   "
21526|NCT02775422|"~     Comparison of the sensibility and specificity of 3 different serological tests and~     evaluation of chicken pox immunity in pregnant women.~      Secondary goals :~        -  Correlation memory / Immunity;~        -  Prevalence of VZV immunity in pregnant women;~        -  Evaluation of cellular and humoral immunity in cases with discrepancy between tests or~          between test and memory;~        -  Evaluation of acceptability of vaccination in the post partum period in non immune~          patients.~      Methods Not randomized prospective study,~      Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years~     old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +,~     grafted patients~   "
21527|NCT02775409|"~     This study is for women scheduled to have immediate breast reconstruction following~     mastectomy using a tissue expander. The primary purpose of this study is to learn whether~     there are differences in the outcome between placing the tissue expander above the muscle or~     below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with~     reconstruction. A secondary purpose is to learn whether there are differences in~     complications and costs between the two locations.~   "
21528|NCT02775396|"~     With the increasing reliance on tablet computers and smartphones in daily life, it is~     important to determine whether and how the prolonged usage of these handheld digital devices~     influences the working habits and refractive status. This study aimed to determine the~     effects of wearing conventional single-vision lenses vs. new progressive addition lenses on~     the working distance and refractive status while playing interactive video game in Chinese~     pre-presbyopic adult computer users.~   "
21529|NCT02775383|"~     Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic~     syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap~     disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be~     followed long term. Clinical data, blood, and tissue samples will be collected to establish~     a biorepository to facilitate the study of the natural history of MDS.~   "
21531|NCT02775357|"~     The study is aimed at testing whether use of a new index to measure risk for HIV in the~     context of HIV testing and counseling will increase demand for safe male circumcision (SMC)~     services among HIV-negative non-muslim men in Rakai. We will also study whether use of the~     index leads to positive sexual behavioral modifications among men. The study will also~     measure acceptability of the index among men.~   "
21532|NCT02775344|"~     This is a prospective randomized study involving 124 patients. All participates will be~     given written information on 3D laparoscopy. They will be randomized according to~     computer-generated random sequence into two groups, 2D and 3D group. The operation will then~     be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other~     type of laparoscopy if difficulty encountered. After the operation, the surgeons will be~     required to fill in a questionnaire self-evaluating the performance using Global rating~     scale component of the intraoperative assessment tool (GOALS), any discomfort encountered,~     any need for change of laparoscopy and their preference on the type of laparoscopy.~      The level of complexity of the operation, duration of operation, blood loss and~     complications will be recorded.~   "
21533|NCT02775331|"~     This study aims to investigate whether use of interactive worktime planning tools that~     support work-time control (possibilities to influence individual shift rosters i.e.~     self-rostering) and guide for health-supporting shift ergonomics will improve health and~     well-being among shift workers. Effects of the worktime planning tools will be studied in a~     quasi-experimental design in the Finnish public sector. Health and well-being at baseline~     (2012-2015), will be compared to follow-up data in 2016-2017 based on questionnaire and~     pay-roll based objective working hour and sickness absence data among those who a) use an~     interactive self-rostering software with a shift ergonomics sub-tool, b) whose working hours~     are designed with a non-interactive shift planning software with the shift ergonomics~     sub-tool and c) whose working hours are designed with a non-interactive shift planning~     software without the shift ergonomics sub-tool.~   "
21534|NCT02775318|"~     The present study has been designed to assess the efficacy and safety of Stellate Ganglion~     Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The~     effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler~     (TCD).~   "
21535|NCT02775305|"~     Frailty is a syndrome characterized by decreased reserve and diminished resistance to~     stressors. The proposed research will evaluate the association of frailty with chronic~     kidney disease (CKD). The prevalence of frailty increases with age and with CKD, but studies~     are needed to determine whether frailty is associated with worsening of CKD and whether~     intervention to treat frailty can improve physical functioning and health-related quality of~     life (HRQOL) as well as slow progression of CKD.~   "
21536|NCT02775292|"~     This phase I trial studies the side effects and the best dose of nivolumab when given~     together with gene-modified T cells and vaccine therapy in treating patients with solid~     tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it~     started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T~     cells are a special type of white blood cells (immune cell) that have the ability to kill~     cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system~     kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the~     patients' T cells in the laboratory and then giving them back to the patient may help the~     body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are~     another type of blood cell that can teach other cells in the body to look for cancer cells~     and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help~     dendritic cells teach the immune system to target cancer cells expressing that protein, and~     further help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells~     and dendritic cell vaccine may teach the immune system to recognize and kill cancer cells~     that express NY-ESO-1.~   "
21537|NCT02775279|"~     Compelling epidemiological evidence indicates that alterations length of telomere, are~     associated with the initiation and development of ischemic heart disease. This study was~     undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be~     used as a risk predictor for acute coronary syndrome.~   "
21538|NCT02775266|"~     To evaluate the effectiveness of non surgical periodontal therapy in addition to~     antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease~   "
21539|NCT02775253|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Recent studies also~     reveal the presence of a subset of cells in WAT that could be induced by environmental or~     hormonal factors to become brown-like cells, and this beigeing process has been~     suggested to have strong antiobesity an antidiabetic benefits. More recently, one study~     showed that Short-term cold acclimation (10 days) improved insulin sensitivity, but did not~     activate the browning of subcutaneous white adipose in patients with type 2 diabetes~     mellitus. Here, investigators hypothesize that a chronic cold acclimation can activate the~     the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus.~   "
21540|NCT02775240|"~     The purpose of this study is to determine how an investigational treatment (maribavir) is~     handled by the body when administered with two already approved drugs (digoxin and~     dextromethorphan). The study will also look at the safety and tolerability when maribavir is~     coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.~   "
21541|NCT02775227|"~     Pancreatic resections carry a high risk for complications, especially pancreatic fistula.~     Both hydrocortisone and pasireotide have been shown to be effective in reducing~     complications in earlier RCTs. The aim of this study is to compare the effectiveness and~     safety of these two drugs in preventing complications of pancreatic surgery.~   "
21542|NCT02775214|"~     The purpose of this study is to compare two different ways of placing breathing tubes for~     surgery. Both ways are used currently to place breathing tubes and are safe and effective.~     This study seeks to determine if one way is better than the other for infants with pyloric~     stenosis.~   "
21581|NCT02774707|"~     Human autologous serum is commonly used in the treatment of dry eye disease. However,~     different patients may have different effect with autologous serum treatment. We would like~     to find if different autologous serum had different component of cytokines in different~     etiologies of dry eye.~   "
21543|NCT02775201|"~     The plantaris tendon is recognised as an important factor in non-insertional Achilles~     tendinopathy (NIAT). A biomechanical study found the plantaris tendon is stiffer and~     stronger than the Achilles tendon (AT), thus reducing its capacity to elongate in response~     to loading. This is hypothesized to result in friction between the AT and plantaris in some~     NIAT patients. Current treatment is conservative management: physiotherapy and high volume~     injection of the paratenon. However 29% of patients fail to respond to conservative~     management and those with plantaris related symptoms require its surgical excision and~     stripping of the ventral aspect of the AT through a 3cm medial incision. This is performed~     in theatres under general anaesthetic with good or excellent results reported in 90% of~     cases.~      Purely cutting the plantaris tendon using a minimally invasive endoscopic technique has also~     been successful. The plantaris tendon is easily visualized under ultrasound scan (USS) and~     tenotomy of tendons under USS guidance is performed elsewhere. Tenotomy of the plantaris~     tendon under USS guidance would necessitate a 5mm incision and may be performed under local~     anaesthetic as an out-patient. The current study thus plans a randomised clinical trial to~     compare outcomes (VISA-A scores and ultrasound tissue characterisation scans) from patients~     with NIAT undergoing plantaris release using an open surgical procedure with those~     undergoing a minimally invasive US guided procedure. The former is known to provide good~     clinical outcomes; however the latter could significantly reduce post-operative scarring,~     recovery times and costs. Findings will ensure ethical, quality and cost effective patient~     care.~   "
21544|NCT02775188|"~     The purpose of this study is to ascertain if home-based therapy with monitoring via~     telemedicine can overcome many barriers to compliance and improve rehabilitation following~     ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks~     during their outpatient physical therapy treatment. Subjects will undergo weekly physical~     therapy or weekly physical therapy paired with InterACTION.~   "
21545|NCT02775175|"~     In this study the investigators will test the impact of a modified Ramadan Fasting regimen~     on health and well-being. The 2016 Ramadan is around summer solstice in Germany making it~     one of the most challenging fasting periods for participating Muslims. The modified Ramadan~     Fasting consists of educational components around fasting, and advice for nutritional~     modifications in order to support health and well-being during Ramadan, while the control~     group will continue to fast as usual. The investigators will measure not only body~     weight/fat but also include measures of psychological well-being, and spiritual practice,~     and serum markers for blood lipids, and blood sugar. With this trial the investigators aim~     to determine, whether such modifications around Ramadan will be beneficial for health and~     well-being.~   "
21546|NCT02775162|"~     A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic~     machine profusion with static cold storage in human liver transplantation.~   "
21547|NCT02775149|"~     Not only caries but also exposure to acids can lead to loss of tooth structure. This~     acid-related tooth structure loss is defined as dental erosion.~      A relationship between dental erosion and occurence of reflux disease was shown in numerous~     studies. On the one hand, patients with dental erosions frequently show reflux disease. On~     the other hand, many - but not all - reflux patients show dental erosions. It is believed~     that certain salivary parameters might explain, why not all reflux patients alike are~     affected of dental erosions.~      The aim of this study is to analyze the relationship and the extent of occurrence of dental~     erosions and reflux symptoms, including investigation of certain salivary parameters.~   "
21548|NCT02775136|"~     HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and~     accurately monitor physiological signs of the brain with minimal discomfort to patients,~     providing information about normal or abnormal brain-related conditions and providing~     decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable~     of detecting and monitoring various neuropathologies, using the acoustic raw data derived~     from the noninvasive procedure.~   "
21549|NCT02775123|"~     Investigators are planning a single center pilot randomized controlled trial to assess the~     potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood~     during cardiac surgery.~      Investigators will screen all patients undergoing cardiac surgery and approach those deemed~     at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular~     replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op~     chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF~     <35%)].~      Patients with end-stage renal disease (dialysis dependence), undergoing an emergency~     procedure or an off-pump procedure, those who decline informed consent as well as those~     enrolled in another conflicting study will be excluded.~      Eligible patients will be approached, consented and enrolled in the trial. Patients will~     then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb~     (intervention arm). The target population is 30 patients (15 per arm).~      For this pilot study, investigators main outcome will be differences between the two arms in~     measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline~     (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.~      Secondary outcomes will be changes in coagulation factors serum levels, the need for~     vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and~     hospital length of stay as well as in-hospital mortality.~      Recruitment period should span from May 2016 to April 2017.~   "
21550|NCT02775110|"~     This study evaluates the discontinuation of natalizumab either immediately or tapered off in~     the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue~     natalizumab immediately and the other half will taper off the drug, having two additional~     infusions, one at six weeks- and one at eight weeks-post discontinuation.~   "
21551|NCT02775097|"~     Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness,~     the epithelial thickness, and the stromal thickness in normal subjects and patients with~     various corneal conditions.~   "
21552|NCT02775084|"~     The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid~     supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half~     of the participants will receive fish oil, while the other half will receive a placebo~     (olive oil).~   "
21601|NCT02774447|"~     The aim of this study is to investigate if day-case closure of ileostomy is feasible and~     safe.~   "
21553|NCT02775071|"~     This study will evaluate the relationship between psychopathology, disordered eating, and~     impulsivity (measured by clinical interview, self-report measures, and objective testing) on~     changes in weight and psychosocial status in the first two years after bariatric surgery.~     Participants will be 300 adults who plan to undergo bariatric surgery. Participants will~     complete four assessments over a two-year period, one at baseline (before surgery) and 6,~     12, and 24 months after surgery. Each assessment will include computer tasks, surveys,~     clinical interview, urine test, waist circumference and height/weight measurement. The~     investigators will track how psychopathology, disordered eating, and impulsivity are related~     to changes in weight and psychosocial status following bariatric surgery.~   "
21554|NCT02775058|"~     The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.~      Synergoss is a granulated bone graft intended for use in dental applications. It is composed~     of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a~     dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on~     the ceramic granule surface.~      The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS,~     a synthetic dental graft coated with collagen. For this observational study, we will enroll~     patients that already received a surgical intervention for sinus augmentation/ socket~     preservation by means of SYNERGOSS to maintain and regenerate bone before installation of~     endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just~     before they receive the surgery for the installation of endosseous titanium implants, about~     24 weeks after the first surgery for the implant of SYNERGOSS.~      The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen~     clinical benefit as declared in the Technical File.~      The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those~     declared in the Technical File.~      The study design is a~        -  National~        -  Monocentric~        -  Prospective: the participants are identified and then followed forward in time.~        -  Observational: participants that have recently received the grafting with SYNERGIES as~          part of normal and foreseen clinical procedures are enrolled in the study when they~          receive surgery for titanium implant placement and observed over time, with no~          substantial intervention other than the foreseen clinical treatment~   "
21555|NCT02775045|"~     The purpose of this study is to improve the overall management of patients with Eosinophil~     Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the~     endoscopy procedure. The investigators plan to identify a biomarker in the blood (a~     measurable substance) that tracks with disease activity and will reduce the need for~     follow-up endoscopies.~   "
21556|NCT02775032|"~     End-of-life care often fails in providing optimal patient-centred care and quality of life.~     Patients frequently suffer from inadequate control of pain, from a lack of communication~     about their illness and options for treatment, and from poor psychosocial and spiritual~     support. Advance care planning (ACP) can tackle these problems by providing patients with an~     opportunity to formulate their wishes and plan their future care, should they become~     incapable of participating in medical treatment decisions. Previous studies show that ACP~     improves concordance between patient's preferences and end-of-life care received and quality~     of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice~     and public consciousness. General practitioners (GPs) are in an ideal position to discuss~     ACP with their patients. By introducing ACP during a routine office visit, GPs can~     facilitate a structured discussion of the patient's wishes for end-of-life care. However, no~     ACP models have been systematically developed and tested in general practice. We developed a~     complex intervention to improve the initiation of ACP in general practice following the~     steps of an international guidance for development and evaluation of complex interventions.~     Before performing a full-scale intervention trial to study the effectiveness of this~     intervention on quality of care and quality of life, this model needs to be validated and~     tested in a pilot trial.~   "
21557|NCT02775019|"~     This study is designed to evaluate the impact of the regular consumption of probiotic~     Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and~     general health in crew members of a naval ship at sea.~   "
21558|NCT02775006|"~     The objective of this study is to investigate the effect of docetaxel monotherapy and the~     combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type,~     ALK negative non squamous cell carcinoma.~   "
21559|NCT02774993|"~     Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial~     burden leading to disease transmission. The cause of tissue destruction leading to~     cavitation in TB is primarily due to the host inflammatory response. A matrix degrading~     phenotype develops in TB, in which the activity of host proteolytic enzymes, specifically~     matrix metalloproteinases (MMPs) is unopposed by their specific Tissue Inhibitors of~     Metalloproteinases (TIMPs), thus driving tissue destruction and cavitation in TB. This~     tissue destruction causes morbidity and mortality. MMP inhibition with doxycycline has shown~     to improve lung function in patients with chronic lung diseases but its use in TB is~     unclear.~      We hypothesise that the MMP inhibitor doxycycline will reduce tissue destruction in human~     pulmonary tuberculosis.~      Specific aims:~        -  To investigate the MMP and TIMP secretion and gene expression in M. tuberculosis (M.tb)~          - infected primary neutrophils and monocytes from healthy volunteers taking~          doxycycline.~        -  To investigate the intracellular signaling pathways modulated by doxycycline~        -  To investigate the effects doxycycline has on biological markers of tissue destruction~          in TB patients~        -  To assess the tolerability and side effects of doxycycline with concurrent standard TB~          therapy~   "
21560|NCT02774980|"~     Patients with depression are frequently treatment resistant. Clinical manifestations of~     depression are various, but cognitive dysfunctions are commonly present. Many factors are~     involved in treatment resistance. As no biological marker is available, clinical markers~     could be considered in predicting response to antidepressive treatment.~      The aim of this study is to investigate the relation between the cognitive changes and the~     remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and~     Rush classification).~      To explore the dynamics of cognitive dimension associated to clinical and functional~     remission, the investigators will observe neurocognitive functioning before and after~     introducing a new antidepressive therapy.~   "
21561|NCT02774967|"~     The gold standard for the treatment of gingival recession, is the coronal repositioning of~     the flap associated with the subepithelial connective tissue graft. The acellular dermal~     matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in~     periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of~     ADM has the advantage of avoiding possible pre and postoperative complications, as well as~     overcome the limitations presented by autograft. The different surgical techniques used for~     root coverage seek predictability and success. For this, besides the type of incision~     placements flap and graft are of utmost importance because the healing benefit and outcome.~      The aim of this study is to compare two surgical techniques for root coverage and evaluate~     which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking~     patients , showing multiple bilateral gingival recessions , class I or II Miller located in~     canine, first and second premolars are selected. Both techniques use the ADM as a graft.~     However , in one Quadrant partial flap will be held together with relaxing incisions through~     an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction~     (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally~     invasive technique periosteal envelope above does not use relaxing incisions , preserves the~     buds will be held , as well as avoiding any scars, the graft will be used to ADM. The~     clinical parameters (probing depth, clinical attachment level, bleeding on probing index,~     height and width of the gingival retraction and height and thickness of keratinized gingiva)~     will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to~     surgical procedures. In addition, measurements of photographic gingival recession with the~     aid of software will be performed.~   "
21562|NCT02774954|"~     The study will test the efficacy of a hour long, one-on-one, active listening counseling~     session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who~     inject drugs (PWID) that research has found to facilitate uptake of injection drug use among~     non-injectors. The study will involve ~1,100 PWID who will be randomized to CTC or an equal~     attention control intervention on improving nutrition. Participants will be recruited in Los~     Angeles and San Francisco, California and followed up at 6 and 12 months to determine~     changes in direct and indirect facilitation of injection initiation among non-injectors.~   "
21563|NCT02774941|"~     The purpose of this study is to compare clinical outcomes related to the current practice of~     using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh~     nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe~     asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators~     hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital~     admissions and decrease length of stay in CMCED when compared to the current practice of~     using a JN and AM or MP.~   "
21564|NCT02774928|"~     Development of pulmonary hypertension (PH) in chronic lung diseases has both functional and~     prognostic implications .~      PH in Lung diseases is usually mild to moderate with preserved cardiac output, and evolves~     slowly alongside the progression of lung disease and hypoxemia .~      However, a minority of patients develop severe PH with elevations in pulmonary artery~     pressure that have been described as ''out of proportion'' to the underlying disease .~      The aim of this study is to compare the characteristics and outcomes of consecutive patients~     with PH-due to lung diseases diagnosed at our specialist referral center over a 1-year~     period.~   "
21565|NCT02774915|"~     Investigators are interested to explore the clinical and pathological characteristics of~     breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during~     pregnancy, median gestational age at diagnosis, the level of the tumor differentiation~     patients present with, during pregnancy, and the hormonal-receptor status. Investigators~     plan to collect prospective quality research databases that could provide further important~     information concerning this condition and serve in both short- and long-term sequelae in~     mother and fetus.~   "
21566|NCT02774902|"~     The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin~     on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants~     following a single oral dose of TAK-438.~   "
21567|NCT02774889|"~     The overall purpose of this multi-phase study is to develop (Phase 1) and test potential~     effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls~     prevention maintenance program for Stepping On (SO) graduates in a group randomized trial~     (Phase 2).~      This application refers to effectiveness component of Phase 2, which entails the randomized~     clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail~     process evaluation of the Stepping Online intervention group only.~   "
21568|NCT02774876|"~     Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and~     protein have been shown to also impact the postprandial glucose control, adding to the~     complexity of meal insulin calculation. Few studies have looked at the effect of~     macronutrients other than carbohydrates on postprandial glucose excursions with the~     closed-loop strategy. The objective of this study is to test whether the single-hormone~     closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed~     carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed~     carbohydrate content only.~   "
21569|NCT02774863|"~     Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO~     Europe). Experiencing NE, psycho-emotional development and brain child may be impacted~     generating psychic suffering signs may progress to severe developmental disorders. The~     recognition of suffering can prevent and treat these disorders.~      This research promotes a multi-professional device, centered on observation, collection of~     expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The~     investigators assume that this collection requires the crossing of looks of a child~     psychiatrist and a repeated observation at home by a trained nurse.~      The two devices described in these two groups are devices set up as part of the routine~     management of these patients. Usually, depending on the means of structures (human and~     financial), one of these devices may be preferred over another.~   "
21570|NCT02774850|"~     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy~     regimens that result in periods of profound neutropenia leaving patients susceptible to~     severe infectious complications. Infectious complications are the leading cause of treatment~     related mortality among AML patients, but there are little clinical data to inform whether~     management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient~     setting. The primary objective of this study is to compare the clinical effectiveness of~     outpatient versus inpatient management of neutropenia in children with AML.~   "
21714|NCT02772978|"~     This study deals with how people decide between rewards of different value. We want to~     understand how the brain's dopamine system impacts this kind of decision making. We will use~     a medication, tolcapone, which can temporarily affect the dopamine system.~   "
21571|NCT02774837|"~     Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide~     afflicting 350 million persons, leading to significant morbidity and mortality due to liver~     disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this~     rescued patients with significant risk of disease progression, but in most circumstances,~     therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping~     therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated~     interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to~     nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite~     disappointing. However a recent showed that the combination of telbivudine and tenofovir in~     a response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in~     patients. Such results require further confirmation. There is currently an unmet need for~     the large number of patients on long term nucleoside analogue therapy who have not achieved~     HBeAg seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long~     term therapy hence an exploration of other therapeutic strategies is attractive. An~     additional benefit of telbivudine has been the surprising improvement in renal function and~     this study seeks to examine whether this can improve the renal impairment that may be seen~     with tenofovir. Our study proposes to examine if the combination of tenofovir and~     telbivudine can improve endpoints. Patients fulfilling inclusion and exclusion criteria will~     be randomized to tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint~     will be a qHBsAg reduction of >1log at week 96, which may predict future HBsAg~     seroclearance, which is also a secondary endpoint. An additional primary endpoint is~     increase in eGFR in the combination arm compared to the monotherapy arm. The study aims to~     enroll 146 patients randomized 1:1 ratio (73:73) patients. Multivariate analysis will be~     performed of baseline and on-treatment factors that predict the primary outcome.~   "
21572|NCT02774824|"~     This is a 9-months extension to the following study, protocol number: 003-03: A study to~     evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients~     undergoing coronary artery bypass grafting (GABG). Participation is allowed exclusively to~     participants enrolled in the main protocol SOMVC001 (GALA).~   "
21573|NCT02774811|"~     Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with~     prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.~      Participating centres are:~      Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation~     Eye Centre, Kisii, Kenya~   "
21574|NCT02774798|"~     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been~     studied in our department over the last 6 years. Sound waves pass into a balloon placed in~     the anal canal and are used to measure the cross-sectional area. By gradually increasing and~     decreasing the pressure in the balloon the investigators can measure the pressure at which~     the cross-sectional area starts to increase and decrease, and the anal canal starts to open~     and close. This assessment mimics the natural opening and closing of the anal canal and the~     effect of squeezing the muscles.~      Rectal intussusception occurs when the rectal wall telescopes into itself distally and is~     termed prolapse when it protrudes through the anal canal. Not all patients will require~     surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal~     incontinence. Currently, the Oxford grading system through radiological testing is used for~     classifying severity of rectal intussusception and prolapse; however this does not give us~     sufficient information about the anal sphincter muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations. In~     previous studies AAR has shown promise in the assessment of faecal incontinence and, that~     unlike manometry, it has been able to distinguish between different types of incontinence.~     Thus far, it has not been studied in patients with rectal intussusception and it is hoped~     that AAR parameters may provide an indication of when rectal intussusception becomes overt~     rectal prolapse. This can inform the clinician to guide further management of a group of~     patients with a condition that can have significant impact on quality of life.~   "
21575|NCT02774785|"~     The new device we are looking at is called the MarginProbe. It is a disposable probe which~     measures the margins of tissue removed to check they are clear of cancer cells, during~     breast conservation surgery. After specimen radiology, allows the Surgeon to remove further~     tissue if necessary, during the same operation if any involved margins are identified. This~     minimises the need for further repeat operations.~      Previous studies carried out elsewhere in the world (USA and Israel) have identified that~     the probe reduces re-excision rate but there has never been a study in the UK.~      The trial involves randomly allocating patients once they are in theatre, to either the~     MarginProbe procedure after breast conserving surgery and radiology has been completed, or~     not.~   "
21576|NCT02774772|"~     The investigators will collect a range of physiological, behavioural and environmental data~     using current mHealth and home-monitoring systems, environmental databases and patient~     characteristics, to determine to what extent asthma control and the occurrence of asthma~     exacerbations can be predicted.~   "
21577|NCT02774759|"~     The goal of this research study is to learn if a home-based physical activity program is~     feasible and can help endometrial cancer survivors lose weight.~   "
21578|NCT02774746|"~     The objective of this study is to investigate the hypothesis that delivery at 36 0/7- 36 6/7~     weeks in stable patients with gastroschisis is superior to observation and expectant~     management. To test this hypothesis, we will complete a randomized, prospective,~     multi-institutional trial across North American Fetal Therapy Network-affiliated~     institutions. Patients may be enrolled in the study any time prior to 34 weeks, but will be~     randomized at 34 weeks to delivery at 36 weeks or observation. The primary composite~     outcomes will include stillbirth, neonatal death prior to discharge, respiratory morbidity,~     and need for parenteral nutrition at 30 days.~   "
21579|NCT02774733|"~     Objective: The main target of this study was to research the correlation between the~     pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients~     with type 2 diabetes (T2DM) without diabetic retinopathy (DR).~      Method: T2DM patients without DR were choose to research the correlation between the~     pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary~     endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c,~     FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the~     retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler~     imaging (CDI).~   "
21580|NCT02774720|"~     The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare~     the effectiveness of centre-based and home-based physical activity in helping people with~     MCI and early dementia meet physical activity recommendations. The primary outcome is~     achievement of physical activity recommendations. Secondary outcomes include~     cost-effectiveness and improvements in health and function.~   "
21715|NCT02772965|"~     The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF~     therapy is more effective than treatment with anti-TNF therapy alone in inducing and~     maintaining steroid-free remission for children with Crohn's Disease.~   "
21582|NCT02774694|"~     Interventional pain management for back and neck pain is widely used, but the indications~     and relative merits of these techniques rest subject to discussion. This study aims to~     identify prognostic criteria for patients who might specifically benefit from interventional~     pain management. Specifically, the nociceptive reflex threshold will be investigated, which~     is a measure of central sensibilisation and thus a potentially important prognostic factor.~   "
21583|NCT02774681|"~     The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor~     activity against the breast cancer that has spread to the brain and also to determine the~     overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that~     has been shown to stop cancer cells from growing. It has been approved in hormone positive~     breast cancer, along with other hormone therapies and has been found to be effective. The~     preclinical studies suggest that the drug may also have activity in other types of breast~     cancer, such as triple negative and HER2 positive breast cancer. The purpose of this study~     is to see if the study drug is effective in patients with brain metastasis, who have triple~     negative and HER2-positive breast cancer.~   "
21584|NCT02774668|"~     The present study is designed to examine the effect of changes in body weight and related~     parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter~     proposed to be studied here is the impact of fructose restriction and weight loss on serum~     uric acid concentrations and arterial stiffness.~   "
21585|NCT02774655|"~     The purpose of this study is to test in overweight and inactive adults whether the new PAI~     eHealh APP leads to better adherence to a physical activity regimen than the wearable step~     counter App from the market leader FitBit, and to evaluate if improved adherence will be~     reflected in a better cardiovascular profile in this group.~   "
21586|NCT02774642|"~     This study aims to examine whether integrating insomnia and PTSD treatment will enhance~     sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing~     integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component~     plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans.~     Such benefits would further the VA's commitment to improving the mental health, recovery,~     and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan.~     Findings from the proposed study offer a unique opportunity to determine the malleability of~     mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes~     among this vulnerable population and to inform future treatment development and research.~     Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic~     impairment and ultimately help affected Veterans live richer, more productive lives.~   "
21587|NCT02774629|"~     Local lyophylized food extracts are available useful in skin prick test and atopy patch test~     to confirm food allergy. However, the investigators want to know the duration that the~     investigators can keep the extracts for the usage in this purpose.~   "
21588|NCT02774616|"~     Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right~     ventricular lead to fulfill requirements by the notified body and to support regulatory~     approval outside of the CE region~   "
21589|NCT02774603|"~     The aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training~     (ALT) compared to overground Locomotor Training in improving ambulatory function and~     health-related quality of life. The investigators hypothesize, that Aquatic Locomotor~     Training is capable of producing outcomes that are as good as, or better than, overground~     Locomotor Training.~      Aquatic Locomotor Training may be another tool for therapists to utilize for clinical~     improvements in function and gait for the Spinal Cord Injury (SCI) population.~      To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes~     among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these~     parameters:~        1. Walking speed and endurance~        2. Functional balance and fall risk~        3. HRQoL~      To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor~     Training modality for the rehabilitation of patients with incomplete traumatic cervical~     Spinal Cord Injury.~   "
21590|NCT02774590|"~     This research is being done to determine the safety and tolerability of timolol in the~     treatment of acne and rosacea. The investigators will also look for specific biomolecular~     changes in acne or rosacea skin when it is exposed to timolol.~      Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.~     In dermatology, it has been used as a treatment to decrease the size of vascular (blood~     vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and~     its use in this study is investigational.~      Many people with rosacea have telangiectasias which are small, red dilated blood vessels on~     the skin. They also suffer from flushing and acne-like lesions. Better treatments than those~     currently available are desired.~      Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that~     affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and~     blackheads that are often called primary lesions because they represent an active form of~     the disease. There are also secondary lesions that can form later; they are known as acne~     scars~   "
21591|NCT02774577|"~     Noninvasive assessment of VO2 during a single session of whole body vibration and changes in~     blood flow caused by the acute activity.~   "
21592|NCT02774564|"~     The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg,~     100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a~     single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).~   "
21602|NCT02774434|"~     The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and~     as part of standard of care all hospitalized newborns are routinely monitored for the~     development of high bilirubin or jaundice every 8-12 hours. One device approved and used in~     both Canada and the United States is the Draeger Jaundice Meter JM-103, a non-invasive~     medical device. It has been proven to be effective in patients >35 weeks gestational age.~     Recently the JM-103 has been upgraded to include a bigger touch screen, greater storage and~     functionality. The rest of the features of the JM-103 and JM-105 are identical. In order to~     test the accuracy of the JM-105 neonates from ≥ 24 weeks gestational age who have or have~     not undergone phototherapy will be prospectively monitored for transcutaneous bilirubin~     (TcB) using the JM-105. The measurements will be compared to a physician-ordered total serum~     bilirubin (TSB).~   "
21593|NCT02774551|"~     This intervention study will be conducted on patients included in a nationwide and~     prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery~     study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden~     between 2013-2018, identified through pathology departments and included in the cohort 1~     year after surgery. A comprehensive interview is conducted by a research nurse during a home~     visit using patient reported outcomes on several HRQOL, psychosocial, emotional and~     nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years~     postoperatively.~      All patients within OSCAR are invited to the intervention trial. Half of the eligible~     patients will be randomised to intervention and half to standard care (control group) by~     means of block randomisation method. The intervention group will be encouraged to adhere to~     a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5~     simple strength training exercises twice a week as instructed by the research nurse. The~     control group will follow their routine daily physical activity. HRQOL measures, height and~     weight, body composition, muscle strength, functional mobility and strength, and dietary~     intake are assessed before and after the intervention. Compliance will be ensured by means~     of a daily physical activity dairy and a weekly follow up on telephone with all patients.~   "
21594|NCT02774538|"~     Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and~     they are associated with genital and oral diseases.~      Agreement between cervical and oral HPV infection has been described from a small group of~     patient. Our study, performed on a greater number of patients, will provide a good~     estimation of this link, between cervical and oral infection, in a French population of~     women with a primary cervical HPV infection.~   "
21595|NCT02774525|"~     The co-occurrence of child maltreatment and parental substance-use problems is a major~     public health problem with serious consequences for children, parents, families, and the~     community at large. The need for effective dual treatment of caregiver substance abuse and~     child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome~     studies with substance-using parents who have engaged in child maltreatment. This project~     examines two evidence-based treatments—Contingency Management for substance-use problems and~     Pathways Triple P parenting intervention to improve parenting for prevention of~     child-maltreatment recurrence. These two systematic interventions are being tested in the~     context of traditional outpatient treatment for substance-use problems.~   "
21596|NCT02774512|"~     This is a monocentric prospective non randomized phase 0 clinical trial targeting patients~     with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary~     team.~   "
21597|NCT02774499|"~     Oral medications like gabapentin and acetaminophen are commonly given to patients prior to~     surgery to provide balanced anaesthesia. Intravenous methadone has been shown to decrease~     postoperative pain as well as postoperative nausea and vomiting, which are known barriers to~     discharge. Oral methadone would be a convenient alternative to give as a preoperative~     medication with its bioavailability approaching 80%. No clinical trials to date have~     explored the utility of oral methadone as a preoperative analgesic to improve postoperative~     outcomes. Current literature shows preoperative IV methadone reduces opioid consumption in~     the perioperative period for cardiac surgeries; therefore, investigators hypothesize that~     preoperative oral methadone will also reduce postoperative opioid consumption in patients~     undergoing sternotomy for cardiac surgery.~   "
21598|NCT02774486|"~     The primary cause of being overweight is an imbalance in calories consumed and energy~     expenditure. A surplus in energy intake might result in body fat deposition and thereby body~     weight gain. Therefore, food intake regulation is crucial to control the body weight gain.~      Appetite regulation plays an important role in determining the food intake, which is a~     complex process influenced by the individual (physiology and psychology) and environment.~     Satiation (process that leads to the termination of eating) and satiety (decline in hunger,~     increase in fullness after a meal has finished) are the precursors of appetite regulation,~     which may be induced by various food components such as macronutrients, water, alcohol and~     non-digestible polysaccharides. High viscosity and swellable/bulking food components such as~     dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or~     clear liquid. Due to its unique physicochemical properties, dietary fibre has been~     recognized as potential ingredient that helps to enhance the sensation of satiety in the~     upper gut by increasing gastric distension and delaying gastric emptying, which subsequently~     reduces the food intake.~      IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a~     fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102~     on appetite reduction in overweight subjects during a 4-weeks interval.~   "
21599|NCT02774473|"~     Patients with a history of metastatic breast cancer who are candidates for participation in~     the companion therapeutic trial, UPCC 06115 A Phase I Trial of Ribociclib (LEE011) and~     Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer may be candidates for this~     imaging study. Patients may participate in this study if they are at least 18 years of age,~     most participants will be receiving care at the clinical practices of the University of~     Pennsylvania. Patients that meet the eligibility criteria will be approached about study~     participation regardless of race or ethnic background.~      The investigators anticipate enrolling up to 20 participants with metastatic breast cancer~     who meet eligibility requirements for this study and for the companion therapy trial UPCC~     06115 A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+~     Advanced Breast Cancer, Accrual will likely occur over approximately 4 years.~      Positron emission tomography (PET/CT) imaging will be used to evaluate proliferative~     activity in sites of metastatic disease using the investigational radiotracer~     [18F]fluorothymidine (FLT). Imaging will occur prior to starting therapy on the separate~     therapeutic protocol UPCC 06115. Patients may undergo a second FLT PET/CT scan following a~     3-day run of ribociclib (LEE011) (day -6 to -4) on Day -3 (± 1 day) and a third FLT PET/CT~     scan on cycle 1 day 1 (-1 day) before starting treatment with Paclitaxel to compare changes~     in FLT uptake measures.~   "
21600|NCT02774460|"~     The PHYSIC study aims to investigate the potential for precision medicine in the treatment~     of high blood pressure.~      It is a double-blind, randomized, repeated cross-over trial with six treatment periods: four~     classes of blood pressure-lowering drugs where treatment with two classes are repeated for~     each patient. The classes of blood pressure-lowering drugs to be tested are a diuretic, a~     calcium channel blocker, an ACE-inhibitor and an angiotensin receptor blocker.~   "
21603|NCT02774421|"~     This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed~     posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of~     intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in~     combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor~     (GM-CSF) in children with relapsed PFEPN~   "
21604|NCT02774408|"~     In this 2-phase cross-over study the investigators test the hypothesis that automated~     adjustment of the inspired oxygen with the combined use of synchronized noninvasive~     SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within~     the intended oxygen saturation range as compared to automated FiO2 adjustment alone.~   "
21605|NCT02774395|"~     The endometrial cancers are among the most common malignancies in postmenopausal women with~     an incidence on the rise. It is most often a endometrioid adenocarcinoma (grade I, II, III).~     Other histological types are represented mainly by the clear cell carcinoma, papillary~     serous carcinoma, the carcinosarcoma. The main risk factors for endometrial cancer are age,~     obesity, diabetes, hypertension, hormone replacement therapy with estrogen and tamoxifen.~      Endometrial hyperplasia usually precedes endometrial cancer is classified by degree of~     cytologic atypia. Tumor grade quantifies the degree of differentiation and significantly~     influences the prognosis. Most research has been applied to define the role of estrogen in~     these cancers, however an accumulation of data indicate that the general process of~     tumorigenesis is closely related to immune and inflammatory microenvironment of the tumor.~     In fact, the microenvironment may be seen as a prognostic parameter of tumors or even~     predictive of therapeutic response.~      Recognized as the key molecules responsible for leukocyte recruitment into the tissues, the~     chemokine-receptor pairs are key players in the immune response, including the anti-tumor~     immune response but also the inflammatory response. The chemokine-receptor pairs are also~     involved in many other basic processes such as proliferation, survival or cell death.~      The objective of this study was to evaluate the prognostic value of the expression of the~     chemokine fractalkine (FKN) and its receptor CX3CR1 for the development of endometrioid~     adenocarcinomas.~      Chemokine FKN has the particularity to exist in two forms, a soluble (FKNs), like all~     chemokines and membrane form (FKNm). The FKNs, resulting from proteolytic cleavage of the~     FKNm, is provided with chémoattractantes properties. FKNm the present adhesion molecule~     properties.~      The role of FKN in cancer biology is complex.~      To date, the role of FKN in endometrial cancer has not been reported. Similarly, the precise~     role of FKN in the physiology of the endometrium is unknown.~      Nevertheless, fractalkine is one of the most expressed in endometrial chemokines. The~     expression of FKN and its CX3CR1 receptor is detected in the endometrium at all stages of~     the menstrual cycle. The respective levels of expression of each are fluctuating and largely~     dependent on the cycle of stage suggesting a possible control by estrogen and progesterone~     control described elsewhere ovarian level and endothelial. The cells of the endometrial~     glandular epithelium, macrophages, neutrophils and NK cells infiltrated in this tissue as~     well as the endothelial cells of blood vessels express FKN. Interestingly, all the cells~     mentioned above express CX3CR1, except for NK cells and unlike most tissues, the CD8 cells,~     present in the endometrium, do not express CX3CR1.~      In addition, the strongest expression of FKN and CX3CR1 cells by endometrial epithelial~     coincides with the maximum activity of the glandular epithelium suggesting a possible~     autocrine loop promoting cell proliferation of the endometrium. Concurrently with the peak~     of fractalkine, an accumulation of monocytes / macrophages and neutrophils is observed in~     the endometrium. It appears, moreover, that the balance between the soluble and membrane~     forms of FKN is important for positioning, infiltration and activity of immune cells within~     the endometrium.~      Current knowledge on the involvement of FKN / CX3CR1 axis in the physiology of the~     endometrium, although incomplete, point unequivocally the potential role of this ligand pair~     / receptor in the physiology of the tissue and also suggest that a malfunction of this axis~     could easily cause various diseases.~      Chronic inflammation of a tissue, largely dependent on macrophage infiltration rate,~     generally represents the tumor development. The endometrium is subjected to physiologically~     cyclic and regular inflammatory episodes, mirrors for the expression of chemokines and~     leukocyte infiltration. However, prolonged leukocyte infiltration establishing chronic or~     prolonged inflammation of the endometrium could help shape a favorable microenvironment in~     tumor development. Curiously, the axis FKN / CX3CR1 is involved in the development of~     several inflammatory diseases, including obesity and diabetes are also risk factors for~     endometrial cancer.~      A change in the expression of FKN and / or CX3CR1 is potentially capable of altering the~     inflammatory physiological cycle of the endometrium and therefore likely to be an element to~     consider in the evaluation of cancer risk factors of the endometrium.~      The assumption is that the FKN / CX3CR1 couple could intervene in the pathophysiology of~     endometrioid adenocarcinomas.~   "
21606|NCT02774382|"~     The purpose of the study is to investigate if treatment with fecal microbiota~     transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients~     with recurrent Clostridium Difficile infections.~   "
21607|NCT02774369|"~     It has been suggested that the practice of physical exercise can improve sleep, but few~     studies have investigated this issue in the context of cancer, despite the proven benefits~     of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the~     efficacy of an aerobic intervention program to that of a self-administered~     cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and~     women with insomnia symptoms and treated within 6 months for a non-metastatic cancer~     participated in the study.~   "
21608|NCT02774356|"~     This mentored student research project is funded by the Graduate Research Partnership~     Program with a projected timeline for data collection in the summer of 2015. Previous~     research has shown that language experience alters the way the human brain processes speech~     information. This phenomenon takes place very early in life and is referred to as Native~     Language Neural Commitment. For instance, as the Japanese language does not have the l-r~     speech sound contrast, Japanese infants start to show difficulty in hearing differences~     between the English l and r sounds at 12 months of age but not when they were at 6 months~     old. Learning the l-r distinction later in life proves to be very difficult for the Japanese~     school students and adults. Brain imaging studies have further revealed specific brain~     regions that are changed by language learning. But the evidence in support of the Native~     Language Neural Commitment theory is based on cortical-level measures. The proposed study~     extends the measurement to the subcortical level at the brainstem. The target language that~     the investigators are interested in studying is Mandarin Chinese, which is known for its use~     of lexical tones to express different words. For instance, the Chinese syllable ma means~     mother when it is spoken with a flat tone, and it means hemp when spoken with a rising~     tone. English, by contrast, does not employ lexical tones, and it is considered a non-tonal~     language. Does the Chinese learning experience fundamental change the way that pitch~     information is coded in the human brain? Does it happen at both cortical and subcortical~     levels? Previous research has shown evidence for a positive answer to both questions. But~     the direct evidence for brain-behavior correlations at the subcortical level is still~     missing.~      The proposed cross-language study will test Chinese-speaking and English-speaking adults to~     investigate Native Language Neural Commitment at the subcortical level. The investigators~     are interested in differences in the two subject populations by examining the relationship~     between brainstem pitch tracking and behavioral pitch perception in linguistic and~     nonlinguistic stimuli.~      The results of the proposed project will contribute to the understanding the role of the~     subcortical brainstem in Native Language Neural Commitment, which have significant~     implications for the development of auditory/speech training programs and assessment tools~     utilizing the brainstem frequency following measure to monitor progress in second language~     learning and test clinical populations.~   "
21609|NCT02774343|"~     The purpose of this research study is to determine whether a medication called pioglitazone~     (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain~     structural changes associated with cocaine use and reduce cocaine craving and drug use in~     cocaine dependent patients.~   "
21610|NCT02774330|"~     Improving healthy food availability and decreasing the availability of high calorie, low~     nutrient products, particularly in underserved communities, has been identified as a leading~     strategy for local governments to prevent obesity. However, policy action in this area to~     date has been limited. This R01 will examine the impact of a local policy change that~     establishes minimum stocking criteria for a wide array of healthy foods as a requirement of~     food store licensing. To our knowledge, this is the only policy of its kind in the US. As~     such, if it is successful, it could serve as an important model policy for other local~     governments seeking to increase healthy food availability and prevent obesity through local~     policy action.~   "
21611|NCT02774317|"~     With the advent of measures to try to decrease the incidence of transfusion-related acute~     lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma~     from female donors who have been pregnant in order to reduce the transfusion of plasma that~     may contain HLA antibodies. This has led to a decrease in the number of donors available for~     the production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the~     United States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within~     24 hours of collection is called FP24, and it is produced when whole blood cannot be~     processed within the 8-hour time period for the generation of FFP. Studies of coagulation~     factors in FFP and FP24 have shown that coagulation factor activities are adequate to~     maintain hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably~     in adults, and occasional hospitals are using these products interchangeably in neonates.~     However, studies concerning the use of FP24 in neonates have not been performed.~      The investigators propose a single center prospective pilot study comparing the clinical~     efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring~     plasma for an International Normalization Ratio (INR) of 1.5 or more.~      This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical~     neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or~     necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg)~     is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated~     by the patient's clinicians, and monitored with prothrombin time (PT), partial~     thromboplastin time (PTT), and INR.~   "
21612|NCT02774304|"~     The goal of the study is to determine Eadyn as a functional measure of arterial load, in~     conjunction with other actual afterload indices, derived from both invasive arterial~     pressure tracing and non-invasive signals, such as arterial saturation, non-invasive cardiac~     output obtained by bio-reactance, and non-invasive stroke volume. A secondary aim is the~     correlation of the different non-invasive signals with the invasive arterial pressure~     tracing characteristics.~   "
21634|NCT02774018|"~     The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction~     (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life~     satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly~     people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several~     selfreport questionnaires and were assessed with Mini Mental State Examination. Participants~     attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48~     sessions (16 weeks) and Participants were evaluated before and after the intervention.~   "
21613|NCT02774291|"~     This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine~     T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination~     chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with~     cancer that has spread to other places in the body (metastatic) and expresses the gene~     NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of~     differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving more than one drug (combination chemotherapy) may kill more~     cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells,~     to kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced~     autologous peripheral blood lymphocytes together with combination chemotherapy and~     aldesleukin may kill more cancer cells.~   "
21614|NCT02774278|"~     This study will assess potentially predictive markers of efficacy in participants with NSCLC~     receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until~     disease progression, unacceptable toxicity or death.~   "
21615|NCT02774265|"~     The purpose of this study is to perform a pragmatic randomized controlled trial to compare~     the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic~     acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower~     extremity fractures.~   "
21616|NCT02774252|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
21617|NCT02774239|"~     This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial.~      The primary objective is to assess the efficacy, safety, feasibility and tolerability of~     SCIG in patients with worsening MG.~      Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are~     considered to be appropriate for immunoglobulin therapy will be screened for the study by~     the treating neurologist.~      Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused~     over 4 weeks in a dose escalating manner.~      Additionally, this study will be assessing the feasibility of employing SCIG as an~     alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG~     versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a~     health-resource perspective and from a patient perspective.~   "
21618|NCT02774226|"~     Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among~     the top five leading causes of death worldwide. Although COPD is a disease of the lungs,~     recent evidence indicates that COPD is associated with multiple systemic consequences~     including vascular endothelial dysfunction. Recently, it has been suggested that more~     patients with COPD die from cardiovascular disease and coronary heart disease than of direct~     pulmonary complications. Examination of the mechanisms that contribute to a reduction nitric~     oxide (NO) bioavailability resulting in vascular endothelial dysfunction in patients with~     COPD are important as endothelial dysfunction has been indicated to be an independent~     predictor of future atherosclerotic cardiovascular disease and events.~   "
21619|NCT02774213|"~     Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed~     during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic~     treatments and be treated for pain relief exactly as they would normally be by the~     Investigator based on their needs. During their regular visits to the Investigator, patients~     will complete questionnaires and Clinical Pain Assessments.~   "
21620|NCT02774200|"~     A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic~     Renal Cell Carcinoma （mRCC） Patients.It`s arm to evaluate the treatment of advanced~     metastatic renal cell carcinoma in patients with objective response rate (ORR), disease~     control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life~     score (QoL) and safety.~   "
21621|NCT02774187|"~     The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with~     hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with~     hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).~   "
21622|NCT02774174|"~     This study is a single centre, non-randomised, post market clinical follow up examining~     retrospective patient data from a series of surgical cases; which involved the~     endoprosthetic replacement of the proximal humerus using the Stanmore Implant Worldwide METS~     (Modular Endoprosthetic Tumour System) Proximal Humeral system.~      The objective of this study is to evaluate the retrospective patient data where patients~     have been followed up for at least 12 months post operation; to demonstrate the safety of~     the METS Proximal Humeral replacement system.~   "
21623|NCT02774161|"~     This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer~     that is early in its growth and may not have spread to other parts of the body. Diagnostic~     procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and~     find out how far the disease has spread.~   "
21624|NCT02774148|"~     The primary objective is to determine if intravenous acetaminophen decreases pain scores and~     the amount of morphine equivalence received as compared to oral acetaminophen in patients~     greater than 65 years old after sustaining a hip fracture.~   "
21625|NCT02774135|"~     This study evaluates the efficacy of Occupational Therapy intervention to promote~     participation in everyday occupation of preschool children with mild developmental~     disabilities.~   "
21626|NCT02774122|"~     This study is to compare the effectiveness of CAABT and masking therapy in the management of~     subjective tinnitus in adults.Half of participants will receive CAABT, while the other half~     will receive masking therapy.~   "
21635|NCT02774005|"~     LEROS is an open-label interventional Phase IV study, designed to further assess the~     efficacy and safety of Raxone® in the long-term treatment of LHON patients.~   "
21643|NCT02773901|"~     In current practice patients with a suspected increase of intracranial pressure (ICP) will~     undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a~     marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a~     new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an~     acoustic signal~   "
30833|NCT02653521|"~     The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive~     radiation therapy, ART) for esophageal cancer, using dose tracking technique with online~     images and deformable registration.~   "
21627|NCT02774109|"~     Purpose:~      To investigate the effects of fish oil on patients with chronic nonspecific low back pain.~      Material and Methods Subjects: 52 participants will be recruited from outpatient department~     of physical medicine and rehabilitation department and by poster.~      Duration: 2016.04.21-2017.03.31~      Methods: The participants will be randomly divided into the experimental group and the~     control group through the draw, with 26 patients in each group. Participants in the~     experimental group receive fish oil plus physical modality treatment. Participants in the~     control group receive placebo plus physical modality treatment.~      Assessment: Before the therapy starts, patients who match the inclusion criteria will be~     evaluated using tools mentioned below:~      General data: age, sex, body height, body weight, occupation, exercise habit~      Rate current, best and worst pain intensity of low back pain during the previous week with~     100mm Visual Analogue Scale (VAS)~      Measure pressure pain threshold with pressure algometer~      Measure lumbar spine range of motion in flexion and extension with tape measure~      Assess endurance of back extensor muscles with Biering-Sorenson test~      Classify the pain origin (nociceptive or neuropathic) with Chinese version of the~     identification pain (ID pain) questionnaire~      Assess the impact of low back pain to daily life with Chinese version of The Roland Morris~     Low Back Pain and Disability Questionnaire (RMQ)~      Assess the impact of low back pain to work performance and fatigue with Chinese version of~     The Health and Work Performance Questionnaire (HPQ) and the Occupational Burnout Inventory~      Assess the impact of low back pain to sleep quality with Chinese version of the Athens~     Insomnia Scale~      Draw 10ml blood for blood test (ESR and hs-CRP)~      Participants will be followed up 4 weeks and 8 weeks after therapy starts and re-assessed of~     pain intensity, pressure pain threshold, lumbar spine range of motion, back extensor muscles~     endurance, and the impact of low back pain to daily life, work, and sleep quality. Blood~     test will be committed again after therapy course finished.~   "
21628|NCT02774096|"~     With more and more people developing hypertension and atherosclerosis, the morbidity rate of~     Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment~     for Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal~     cord could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death.~     So spinal protection is always the hot topic in clinical research.~      Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable~     hemodynamics, clean and non-toxic.The animal researches have showed the protective effects~     of xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues~     suggest that Xenon may have the potential protection of spinal cord in patients undergoing~     aortic dissection repair.In order to clarify this hypothesis, the investigators designed~     this randomized, controlled clinic trial to evaluate the protection of Xenon against spinal~     cord ischemia-reperfusion injury and the potential mechanisms~   "
21629|NCT02774083|"~     Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental~     deterioration and preserve cognitive abilities among people aged 60 and above. The program~     is an applied practicable program based on the theories of Structural Cognitive~     Modifiability as well as on a Mediated Learning Experience. The program takes into~     consideration the unique characteristics and requirements of the older population. The~     program is composed of a variety of cognitive tasks that offer systematic activities~     intended to stimulate mental and cognitive development.~      Objective: To examine the influence of the Feuerstein Program on the cognitive function and~     well-being of participants suffering from Mild Cognitive Impairment (MCI).~      Hypothesis: The Feuerstein Program will improve cognitive abilities and functional~     well-being of the participants.~      Methods: Residents of retirement homes will be offered to participate in the research.~     Participants will undergo cognitive and functional assessments that will be carried out on~     four specific dates. The participants of the Intervention Group will participate in the~     Feuerstein program using a method of mediated learning while the Control Group will~     participate in a program of the Adler Institute involving activities aimed at social and~     emotional development without specific cognitive skill training.~   "
21630|NCT02774070|"~     This study detects the presence of atlantoaxial joint affection in symptomatic versus~     asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance~     imaging of the cervical spine~   "
21631|NCT02774057|"~     Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic~     inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical~     feature of IBD. It is encountered in one third of IBD patients, and is the most common~     extraintestinal complication of this disease. Anemia has a significant impact on the quality~     of life of affected patients. Many patients with IBD frequently complain of chronic fatigue~     commonly caused by anemia and this may be as debilitating to patients as abdominal pain and~     diarrhea. Anemia in IBD is multifactorial, but is most commonly the result of iron~     deficiency anemia (IDA) and rarely due to anemia of chronic disease (ACD). Oral iron~     supplementation has been used traditionally for the treatment of IDA but studies have shown~     that it may result in disease exacerbation by increasing oxygen free radicals within the~     lumen of the gut via the Fenton reaction. A recent study done in University Hospitals~     Birmingham, United Kingdom, has shown that treatment with oral iron results in failure to~     control anemia in 2 out of 3 IBD patients, which is in part due to the side effects reported~     by over half of patients. Captafer is a new iron-free oral preparation that contains a~     special type of oligosaccharides from fish muscle tissue able to make the intestine absorb 3~     to 5 times more iron in comparison to the meat factor. Moreover, Captafer contains other~     vitamins and supplements that improve anemia.~   "
21632|NCT02774044|"~     The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung~     surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory~     distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).~   "
21633|NCT02774031|"~     Low flow anesthesia (LFA) is used less than desirable, partly because one has considered~     that there might be danger of underdosing of anesthesia gas and thus risk of awareness under~     anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the~     inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few~     anesthesia machines include an automatic gas control system: the Aisys machine, by GE~     Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden).~      Since these machines were introduced, only a few studies have reported their functionality~     and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The~     potential reduction may have been underestimated because in the majority of cases a FGF~     higher than 1 l/min was still used.~      In this study the consumption of anesthetic gas (desflurane) delivered by two different~     anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control~     delivery systems. Gas consumption and the time needed to reach the target level of~     anesthetic gas concentration will be assessed. Data needed will be collected directly from~     the anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient~     journal). The results of this study are of interest for intraoperative ventilation and of~     economic and ecological interest~   "
30932|NCT02652208|"~     The purpose of the study is to compare two different types of decision support materials for~     patients considering treatment for chest pain or chest discomfort from heart disease.~   "
21636|NCT02773992|"~     Medical The Internet of Things (IoT), a recent breakthrough in communication technology,~     could be helpful in improving health care delivery and saving medical costs, but regarding~     pulmonary nodule management it is still at the basic understanding. Investigators adopt~     Internet of things medical three plus two type pulmonary nodule diagnosis which chun-xue~     Bai put forward, used a developed a mobile phone-based IoT (mIoT) platform and initiated a~     randomized, multicenter, controlled trial to value clinical effectivity of Internet of~     things medical three plus two type pulmonary nodule diagnosis in the management of~     pulmonary nodules. In this study, at least 600 patients with pulmonary nodules (no typical~     symptoms, often single, clear boundary, increased density, soft tissue shadow surrounded by~     lung parenchyma with diameter ≤3 cm) will be randomly allocated to the control group, which~     receives routine follow-up, or the intervention group, which receives Internet of things~     medical three plus two type pulmonary nodule diagnosis management. Endpoints of the study~     include: (1) The positive diagnosis rate of lung cancer in I stage; (2) 5 year disease-free~     survival rate and overall survival rate; (3) direct medical costs per year. Results from~     this study should provide direct evidence for the suitability of Internet of things medical~     three plus two type pulmonary nodule diagnosis in pulmonary nodules patients management.~   "
21637|NCT02773979|"~     This phase 1, double-blinded, randomized, placebo-controlled study will enroll 36 healthy~     volunteers to receive 1 of 3 regimens of PfSPZ or placebo, randomized 3:1. They will also~     receive suppressive doses of chloroquine (CQ). 10 weeks post 3rd immunization (and 4 weeks~     after last dose of CQ) subjects will be subjected to controlled human malarial infection.~     The primary objective of this study is to 1) evaluate the safety and tolerability of~     escalating doses of Sanaria PfSPZ Challenge administered by DVI on Days 3, 10, and 17 to~     healthy malaria-naïve adults taking suppressive doses of CQ.~   "
21638|NCT02773966|"~     The objective of this randomized phase III study is to test the superiority of Kypho-IORT~     compared to EBRT with regard of time to pain reduction in patients with painful vertebral~     metastases. Therefore patients will receive intraoperative radiotherapy (8 Gy with Intrabeam~     System/Carl Zeiss) during kyphoplasty (Arm A) or external beam radiotherapy with 30 Gy,~     added in 3 Gy per fraction on a conventional linear accelerator or 8 Gy single dose (only~     for international study centers, not permitted in Germany) (Arm B).~   "
21639|NCT02773953|"~     Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a~     telemonitoring unit added on CPAP device allowing to obtain a daily report of usage~     duration, mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to~     assess the impact of telemonitoring on the delay to the first technical intervention after~     CPAP titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep~     unit. The shortening of this delay could help to improve adherence during the first weeks of~     treatment. As a secondary aim, the investigators would like to assess the impact of~     telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial~     period.~   "
21640|NCT02773940|"~     The purpose of the study is to collect information on prostate tissue biopsies collected~     with the ClariCore System during a radical prostatectomy procedure. The ClariCore System is~     designed to improve how biopsies are taken from the prostate by using light sensors (fiber~     optics) that can see changes in the tissue. The information collected from the study will be~     used to develop a method to tell the difference between normal and suspicious tissue to help~     guide the physician during a biopsy procedure.~   "
21641|NCT02773927|"~     Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity,~     dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The~     study of certain adipokines such as adiponectin has demonstrated an inverse association with~     insulin resistance, especially in Latin population lower levels of adiponectin have been~     observed compared to other ethnic groups. It appears to be an important molecule that is~     involved in limiting the pathogenesis of obesity-linked disorders and may have potential~     benefits as a marker to evaluate the effect of possible interventions on the MetS components~     and its complications.~      Metformin is treatment of choice in patients with MetS, due to its low cost and~     pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases~     hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as~     well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes~     mellitus in subjects with an abnormal fasting glucose.~      A second choice to lower the risks would be the addition of a fiber like inulin, a~     prebiotic, since it has demonstrated metabolic benefits on lipid and carbohydrates~     metabolism by several mechanisms proposed such as induction of lipogenic enzymes by glucose,~     production of short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and~     glucagon-like peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of~     inulin is the agave.~      It is expected that the combination of metformin plus agave inulin will produce a beneficial~     impact through pharmacological synergism and that will produce changes in the~     pathophysiology of MetS.~   "
21642|NCT02773914|"~     The present study Comprehensive Geriatric Assessment for frail older people in Swedish~     acute care settings - a randomized controlled study comprises two study arms: one~     intervention and one control group. The intervention Comprehensive Geriatric Assessment~     (CGA) for frail older people addresses people 75 years and older who are seeking acute~     hospital care at the hospital emergency department, and who are identified as frail. The CGA~     intervention, including a multidisciplinary team that assesses the patients~     socio-demographic background, social network, health and medical history, medications,~     functional status, cognitive status, nutritional status, somatic status and psychosocial~     status including depression, as well as treatment and planning for discharge and follow-up,~     contributes to a person-centred, and a comprehensive assessment tailored for each person.~     The results of this study are expected to optimize the implementation of future complex~     interventions and lead to the improvement of the care, support and rehabilitation for frail~     older people with complex needs.~      This study will contribute to an evidence base for full scale implementation of CGA in~     Swedish hospital care. The process evaluation, aiming to provide insight into function and~     consequences of the intervention, why it works or fails, is an important part of the design~     that will contribute with insights into real life conditions that may be challenging in~     implementing CGA. The investigators will evaluate fidelity and quality of the~     implementation, clarify causal mechanisms and identify contextual factors associated with~     variation in outcomes. The development of screening for frailty and CGA are potential and~     important tools to identify needs of this older population, and to direct the right health~     care actions towards those in most need.~      The study will address the following research questions:~        1. Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute~          hospital settings:~             -  increase/maintain independence, functional status, health related quality of life~               and life satisfaction?~             -  increase satisfaction with health care?~             -  reduce health care consumption?~        2. How feasible and acceptable are the study processes and procedures of CGA from the~          perspective of care givers and older persons in Swedish settings?~   "
21750|NCT02772510|"~     The purpose of the present study was to investigate the effects of game-based virtual~     reality rehabilitation combined with functional electrical stimulation on distal upper~     extremity function, and compare the findings to those of functional electrical stimulation~     in stroke survivors.~   "
21644|NCT02773888|"~     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.~     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's~     head.~      HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately~     monitor ICP with minimal discomfort to patients, and provide information about normal or~     elevated ICP levels to the physicians.~   "
21645|NCT02773875|"~     This is a randomized crossover study testing the efficacy of the Fault Detection algorithms~     using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with~     type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three~     weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized~     order~   "
21646|NCT02773862|"~     Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit~     (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure~     (ICP) is measured. An increase in the intracranial pressure might suggest secondary~     neurological deterioration and is considered an alarming symptom. Current practice is to~     insert an invasive monitor through a burr hole in the skull with the risk of bleeding and~     infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP~     non-invasively through an acoustic signal.~   "
21647|NCT02773849|"~     Previous multi-dose Phase I and Phase II clinical studies have demonstrated that Instiladrin~     is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III~     study is designed to expand those observations using a high dose of Instiladrin in patients~     that are BCG Unresponsive which refers to patients with high grade NMIBC who are unlikely~     to benefit from and should not receive further intravesical BCG.~   "
21648|NCT02773836|"~     The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco~     Products Directive (TPD) within the context of FCTC ratification at an EU level. The~     investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate~     the psychosocial and behavioral impact of TPD implementation and FCTC implementation,~     through the creation of a cohort study of adult smokers in 6 European Member States (EU MS),~     Germany, Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD~     study design.~      EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation~     programme under grant agreement No 681109~   "
21649|NCT02773823|"~     The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular~     health among obese schoolchildren. The intervention methods include dietary instruction and~     exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids~     and glucose.~   "
21650|NCT02773810|"~     Currently there are approximately 400 women of reproductive age enrolled in outpatient~     monitoring of warfarin therapy through AMS. The investigators do not have any data on the~     percentage of women who are using family planning, but anecdotally the providers report that~     it is very low. The investigators believe that an educational intervention with an emphasis~     on the safest and most effective methods, long-acting reversible contraception (LARC), aimed~     specifically toward women with medical conditions requiring anticoagulation, combined with~     on-site provision of LARC can improve uptake of these methods. Ultimately, the use of the~     most effective methods of contraception will prevent unplanned pregnancy and the unnecessary~     maternal morbidity and mortality associated with high-risk pregnancies in women with these~     conditions.~   "
21651|NCT02773797|"~     A variety of medications have been used to treat the anxiety, discomfort, and fear~     associated with continuous and sudden episodic breathlessness in patients with advanced~     respiratory disease. Opioids and benzodiazepines, used alone or in combination, are commonly~     prescribed for this distressing symptom. Clinicians are concerned about the adverse effects~     of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines.~     Recent studies have shown that benzodiazepine use is associated with adverse respiratory~     outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD). Dexmedetomidine~     may be an alternative to current drug therapies for breathlessness. Dexmedetomidine produces~     a dose dependent sedation, anxiolysis, and analgesia without respiratory depression or~     cognitive dysfunction.~      The drug can be administered intranasally (IN-DEX) to induce light to moderate sedation of~     several hours duration.~      The objective of the research is to assess the dose dependent safety and efficacy of~     intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable~     patients with severe COPD. This will be accomplished in a staffed acute care setting with~     routine vital signs monitoring and continuous pulse oximetry. Patients will be assessed~     objectively and subjectively for their level of sedation by validated sedation scales.~      The study is an extension of a similarly designed pilot study which did not include a~     placebo comparison. Results of the study will be helpful to design additional trials with~     intranasal dexmedetomidine in acutely symptomatic COPD patients, exertional dyspnea and~     exercise performance, and dyspnea treatment comparisons.~   "
21652|NCT02773784|"~     -  This is a prospective, single-center, non-randomized, non-controlled study.~        -  The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of~          CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in~          invasive breast cancer. The concordance of these biomarkers between CNB and surgical~          specimen was varied in previous retrospective reports. The aim of this study is to~          determine the discordance of these biomarkers between CNB and surgical specimen and the~          influence of making treatment strategy by the discordance.~   "
21662|NCT02773654|"~     The purpose of this study is to determine the ability of a mobile clinical application to~     reliably and accurately track scapular motion in people with asymptomatic and symptomatic~     shoulders. The ability to accurately and reliably measure shoulder position clinically is an~     important first step in choosing the best treatment techniques to treat shoulder movement~     dysfunction. Therefore, the primary objectives of the study are:~        1. To determine the inter- and intra-rater reliability of shoulder joint position~          measurements in symptomatic and asymptomatic subjects, by using a mobile application,~          with and without use of a handle for a smartphone~        2. To determine the validity of the shoulder joint position measurements measurements as~          described above.~   "
21751|NCT02772497|"~     The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated~     with intravitreal ziv-aflibercept.~   "
30933|NCT02652195|"~     The proposed study will investigate the effects of intranasal oxytocin administration on~     neural activity associated with social and non-social motivation.~   "
21653|NCT02773771|"~     Acute muscle wasting occurs early and rapidly during the first week of critical illness and~     contributes substantially to weakness acquired in the ICU. Muscle wasting and subsequent~     weakness is associated with delayed liberation from mechanical ventilation, prolonged~     hospital length of stay, long-term functional disability, and worse quality of life.~     Moreover, low muscle volume as well as ICU-acquired weakness increases the risk of mortality~     in critically ill patients. Although several factors likely accelerate skeletal muscle~     wasting during critical illness (e.g., immobility, inflammation, multi-organ failure), the~     understanding of the underlying mechanisms remains limited and is reflected in the lack of~     effective interventions to prevent the loss of muscle mass in ICU patients. To-date, there~     is no known safe and effective pharmacological or nutritional intervention to attenuate the~     acute loss of muscle mass in ICU patients.~      Leucine is an amino acid widely regarded for its anabolic effects on muscle metabolism.~     However, the concentrations required to maximize its anti-proteolytic effects are far~     greater than the concentrations required to maximally stimulate protein synthesis. This has~     resulted in the search for leucine metabolites that may also be potent mediators of anabolic~     processes in skeletal muscle; one such compound is β-hydroxy-β-methylbutyrate (HMB). HMB is~     thought to primarily facilitate protein synthesis through stimulation of mammalian target of~     rapamycin (mTOR), a protein kinase responsive to mechanical, hormonal, and nutritional~     stimuli that plays a central role in the control of cell growth. Randomized, controlled~     trials to assess the effect of HMB supplementation on clinical outcomes in patients with~     chronic diseases are limited, and even fewer studies have assessed its effects on skeletal~     muscle metabolism during critical illness. Furthermore, despite compelling preclinical~     evidence, the exact mechanisms underlying the effect of HMB supplementation during acute~     catabolic stress in humans is not well defined. Therefore, the investigators goal is to~     study the impact of early HMB supplementation on skeletal muscle mass in ICU patients and to~     explore the mechanisms by which HMB may exert its effects on skeletal muscle metabolism~     during critical illness.~   "
21654|NCT02773758|"~     This will be a single centre, two week, randomised, examiner blind, two treatment arm,~     parallel design, stratified (by maximum baseline Schiff sensitivity score of the two~     selected test teeth), controlled study, in participant with at least two sensitive teeth~     that meet the study criteria at the Screening and Baseline visits. The study will be~     conducted in participants in good general health, with pre-existing self-reported and~     clinically diagnosed tooth sensitivity at screening.~   "
21655|NCT02773745|"~     With aging population, total knee arthroplasty is performed with increasing frequency.~     Although the surgery is successful in general, significant number of patients suffers~     persistent pain and disability. Traditional risk assessment tool have been focused on single~     organ systems. Our investigators have found that mobility, assessed by the Mobility~     Assessment Tool short form (MAT-sf), is a simple and accurate method to predict~     postoperative outcome, including length of stay, postoperative complications, and nursing~     home placement for older patients. Prehabilitation is the process of enhancing a person's~     functional capacity to withstand an incoming stressor. Although multiple studies have tested~     prehabilitation before joint replacement surgery, results have been mixed. The investigators~     hypothesize that patients with limited mobility are most likely to benefit from~     prehabilitation. The investigators plan to use individualized aquatic exercise as a~     prehabilitation tool to enhance compliance; the resistance of water strengthen muscle and~     increasing energy expenditure; the buoyancy of water provides environment where the joints~     are not weight bearing. The aims of the study are: 1) To evaluate the feasibility of~     prehabilitation using 6-8 weeks of aquatic exercise in 40 geriatric patients who are~     scheduled for total knee arthroplasty for osteoarthritis; 2) To examine the effects of 6-8~     weeks of aquatic exercise on mobility, pain, stiffness, physical function, cognitive~     function and depression; inflammatory markers and 3) To estimate the effect of~     prehabilitation on postoperative outcomes. The investigators plan to enroll 40 patients age~     >50, who are scheduled for elective primary total knee replacement. Investigators will~     screen patients in the Preoperative Assessment Clinic and enroll patients who have decreased~     mobility, measured by MAT-sf. Patients will be randomized into either a prehabilitation~     group or a usual care group. All the participants will undergo extensive assessment on their~     pain, stiffness, and physical function, depression, balance and cognitive function using the~     Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the expanded Short~     Physical Performance Battery (eSPPB), and Montreal Cognitive Assessment (MoCA). Serum~     inflammatory markers will be assessed at the baseline. The prehabilitation group will~     undergo 6-8 weeks of individualized aquatic exercise in a heated pool (60 min/session, 3~     times per week). Aquatic equipment maybe used to challenge balance and trunk stabilization.~     All participants will be reassessed immediately before surgery and 4 weeks after the surgery~     using WOMAC, eSPPB, MoCA and MAT-sf. Serum inflammatory markers and body composition will be~     reassessed at the same time points. The primary outcome of interest is will be postoperative~     complications, length of stay, Intensive Care Unit length of stay, and institutionalization.~     If successful, investigators will have sound pilot data for several critical health outcomes~     with which to support an external proposal for a larger-scale study.~   "
21656|NCT02773732|"~     The purpose of the first part of this study is to establish the maximum tolerated dose (MTD)~     of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in~     patients with resistant acute myeloid leukemia (AML). The purpose of the second part of this~     study is to determine if the established dose of oral ciprofloxacin in combination with oral~     etoposide is effective in the treatment of patients with resistant AML.~   "
21657|NCT02773719|"~     Traditionally, healers are willing to look after, two out of three French citizens have~     already appealed to them at least once during their lives. Many healers in good faith are~     exercising their magnetism as a gift often inherited from elders. Now, they create~     interest of doctors who do not hesitate in some cases to ensure their cooperation, to~     implicitly recognize their mysterious talents. Some serious studies have examined these~     practices: Several studies have been conducted on the influence of biofield therapies in~     pain, depression and fatigue in cancer disease. The investigators propose a study of the~     effect of magnetism on the wart disease whose cure is objectively assessable.~      Sixty-two subjects in total would be included, comparing 2 proportions observed: the~     proportion of healing in the group treated with a real biofield therapist (recognized and~     affiliated to the National Group for Alternative Medicine in France) to the proportion of~     healing in the group treated with a fake biofield therapist (someone assessed as not~     having capacity to magnetize). The fake biofield therapist, placebo, has been trained to~     replicate gestures during a training validated by an independent recognized biofield~     therapist.~      If the results are in favor of magnetism, this pilot study would encourage additional~     investigations to determine whether the practice of magnetism may be a paramedic~     specialization.~   "
21658|NCT02773706|"~     The DECADES trial seeks to determine the comparative effectiveness of specialist-centered~     management of anxiety and depression vs. an imbedded and automated psychology referral for~     all subjects who screen positive for anxiety or depression.~   "
21659|NCT02773693|"~     The primary objective of the current study is to determine if providing cognitive-behavioral~     therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT)~     results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is~     to determine if the sequencing of CBTl&N before or after CPT results in differential effects~     on PTSD and sleep symptom reduction.~   "
21660|NCT02773680|"~     Current EIT analyses are based on the assumption of a circular thorax-shape and do not~     provide any information on lung borders. The aim is to obtain the body and lung border~     contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds~     of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT~     reconstruction models.~   "
21661|NCT02773667|"~     Correlation analysis between estimated renal function and biological half life of 131-I~     during radioiodine treatment of patients with differentiated thyroid cancer.~   "
21673|NCT02773511|"~     The study evaluates the effectiveness of surgical or non-surgical treatment for children~     type 1 humeral condyle fracture.Half of the participants receive surgical treatment and the~     other half receive non-surgical treatment~   "
21663|NCT02773641|"~     Women with provoked vestibulodynia (PVD) suffer from severe dyspareuni and often present a~     hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The~     rationale for the study is that for women with PVD who don't succeed to restore the function~     of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by~     decreasing the high muscle tonus and thus possibly reduce the coital pain.~   "
21664|NCT02773628|"~     Eviction methods for dust mite allergy have been evaluated in asthma control in a recent~     Cochrane meta-analysis. None have shown efficacy on asthma control and there are not~     recommended. The purpose is to evaluate the efficacy of a new commercialized system~     (Acar'Up) to decrease dust mite load and to assess its impact on the possibility to perform~     inhaled corticosteroids step down in stable asthmatics.~   "
21665|NCT02773615|"~     Background In the differential diagnosis of unstable angina versus non-anginal chest pain,~     an exercise test is often the modality of choice for further investigation. However, in a~     substantial number of patients exercise testing is less informative, because of insufficient~     exercise capacity or pre-existing ECG-abnormalities. In patients with low pretest~     probability of coronary artery disease (CAD), Coronary CT angiography (CTA) has an excellent~     negative predictive value, but in patients with an intermediate or high pretest probability~     of CAD estimation of the hemodynamic significance of a stenosis has only limited~     specificity. CT perfusion (CTP) is a new method looking at myocardial perfusion during~     vasodilative stress with a sensitivity, specificity, positive predictive value and negative~     predictive value of respectively 81%, 93%, 87% and 88%, whereas radiation is limited to a~     maximum of 5 millisievert (mSv).~      Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a~     feasible and safe investigational workflow in patients with unstable angina or nonanginal~     chest pain in the emergency department.~   "
21666|NCT02773602|"~     Comparing the duration of pain relief from caudal analgesia when adjuncts like~     dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.~   "
21667|NCT02773589|"~     Achalasia is an esophagus motor disability characterized by a lack of relaxation of the~     lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical~     technique allowing to cure this pathology. In this study, investigators are using a new~     endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral~     Endoscopic Myotomy). This technique does not require any cutaneous incision.~      Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated~     by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this~     context, the introduction of the POEM technique seems to be an original approach and a~     natural evolution to a new generation of surgical endoscopy.~   "
21668|NCT02773576|"~     A one year, open-label, study to evaluate the safety and tolerability of risperidone~     implants as a maintenance treatment in patients with schizophrenia~   "
21669|NCT02773563|"~     The insufflation of air in the viscera is indispensable during endoscopy. However, the~     distension of the bowel that follows is often the cause of abdominal discomfort.~      Carbon dioxide (CO2) has been widely used for insufflation in endoscopy. CO2 insufflation is~     demonstrated in the literature to cause lower abdominal discomfort as it is quickly~     reabsorbed by the body.~      Endoscopic ultrasonography (EUS) is a method in which you associate the endoscopic view and~     the ultrasound vision obtained from the inside of the viscera.~      The diagnostic accuracy of EUS is undermined by the visual artifacts caused by the presence~     of air between the probe and the organ to be studied.~      Although the use of CO2 is already widely applied by many endoscopists, there are no studies~     to date concerning the use of CO2 during EUS from the point of view of the abdominal~     discomfort related to the procedure and/or the quality of the images obtained.~      The main purpose of the study is to assess whether the insufflation of CO2 results in a~     reduction of discomfort of the patients undergoing EUS. The study design is observational~     because no randomization or other interventions are planned; participants will be assigned~     to either air or CO2 insufflation according to the endoscopic room equipment (one room is~     equipped with CO2 insufflation while another endoscopic room is equipped just with air~     insufflation) and the results of the two groups will be compared. Among the secondary goals~     the investigators want to evaluate whether insufflation of CO2 is associated with a~     reduction in the dose required for patients sedation. Finally, the investigators want to~     clarify whether the use of CO2 is able to produce less visual artifacts than air and thus~     improve the quality of EUS images.~   "
21670|NCT02773550|"~     This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of~     Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and~     prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol~     patients were still approximately every two months, in clinical practice, to observe the~     survival and answers to other treatments. All the scans are part of the normal routine. The~     realization of diagnostic tests and drug treatment will be performed regardless of the~     patient's participation in the study as part of routine clinical practice All patients who~     meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is~     estimated in 44 patients.~      Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade~     consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1~     to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11),~     followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration~     of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4~     and prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of~     1, 0 mg / m2 sc (days 1, 4).~      Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be~     administered in a single two hours separately taking any food and prednisone be taken in the~     morning with or immediately after a meal. The amount in mg will be calculated based on the~     body surface, to be calculated on day 1 of each cycle. Velcade for administration,~     calculated on day 1 of the cycle will be the same dose throughout the entire cycle. If a~     patient experiences a gain or loss of remarkable weight within the cycle, the dose to be~     administered will be recalculated based on the new body surface. The appropriate amount of~     Velcadeserá dispensed in a sc injection. Velcade dose between two leave at least 72 hours~   "
21671|NCT02773537|"~     The primary aim of this pilot study will be to develop a clinically meaningful,~     patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of~     different strategies for achievement of the ideal balance between analgesia and functional~     mobility following total knee arthroplasty (TKA).~   "
21672|NCT02773524|"~     Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no~     established standard treatment following failure of first and second line chemotherapy.~     Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase~     inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic~     (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in other solid tumours.~     Regorafenib was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general~     aim of this study is to determine if regorafenib improves overall survival in refractory~     AGOC.~   "
21676|NCT02773472|"~     A multimodal approach for management of post-operative pain is used to improve analgesia,~     minimize side effects, and improve recovery. Nevertheless, opioid analgesics and intravenous~     patient controlled analgesia remains the mainstay of postoperative analgesia after~     colorectal surgery. Opioids are associated with various side effects such as nausea,~     vomiting, sedation, dizziness, respiratory depression, urinary retention and reduced bowel~     movement. These side effects are unpleasant and lead to prolonged recovery.~      Use of non-pharmacological analgesic techniques may improve postoperative pain control and~     reduce opioid consumption. Acupuncture has been used for over 3000 years in China for~     treatment of pain and various other conditions. Acupuncture and related techniques are~     simple and safe. There is evidence that acupuncture can reduce postoperative pain intensity,~     opioid consumption, and opioid related side effects.~   "
21677|NCT02773459|"~     This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated~     advanced biliary tract cancer, and to explore the predictive biomarkers for future~     large-scale clinical trials using this combination.~   "
21678|NCT02773446|"~     The purpose of this study is to determine the safe and optimal dose and regimen (fasting~     duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.~      Additionally, an assessment of homologous protection following rechallenge with B7A will be~     assessed.~   "
21679|NCT02773433|"~     The primary aim of this research is to determine the feasibility of conducting a randomized~     controlled trial comparing two ventilation modes in patients admitted to the ICU who require~     mechanical ventilation. The investigators plan to include patients on mechanical ventilation~     with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer~     than 48 hrs. There are a number of potential barriers to enroll patients in the study.~     Importantly patients will have to be enrolled within 48 hours from the time they meet~     inclusion criteria.~      The secondary aims are to determine the impact of proportional assist-ventilation (PAV)~     versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free~     days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic~     medications, use of antipsychotic medications, length of stay in the intensive care unit and~     hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of~     patients.~   "
21680|NCT02773420|"~     Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar~     System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective~     pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients~     previously.~      Methods: Patients seen at a colorectal clinic in a single institution with grade I-II~     hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a~     modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar~     energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of~     hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is~     the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and~     soiling. This is measured with a patient completed questionnaire documenting each symptom's~     frequency from 0 to 3 (i.e. 0 is < 1x/month; 3 is daily) before therapy and at 3 weeks and 6~     month follow-up. Post-treatment pain scores were recorded using the visual analog scale~     (VAS).~   "
21681|NCT02773407|"~     The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best~     empirical treatment for undifferentiated febrile illness in Nepal~   "
21682|NCT02773394|"~     The purpose of the study is to describe: 1) the clinical profile, past and current~     management of participants with hepatitis C in Brazil reference centers; 2) the current~     situation about demographics characteristics, liver disease progression and clinical~     outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and~     previously exposed to antiviral treatment without sustained virological response (SVR).~   "
21683|NCT02773381|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     oral semaglutide compared with placebo on postprandial glucose and triglyceride metabolism,~     energy intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes~   "
21684|NCT02773368|"~     This trial is conducted globally. The aim of this trial is comparing glycaemic control and~     safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on~     therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2~     diabetes mellitus.~   "
21685|NCT02773355|"~     This trial is conducted in North America. The aim is to investigate timely detection of~     pancreatitis cases as well as cases of suspicion of serious and non-serious adverse~     reactions possibly or probably related to Saxenda® in Mexican patients.~   "
21686|NCT02773342|"~     The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the~     world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in~     the last decade, the outcome of patients with IPA is still unsatisfactory and needs~     improvement. Particularly, recent developments in diagnostic imaging, including introduction~     of high-resolution computed tomography (CT) into standard procedures, made a place for~     improvement of diagnosis of IPA.~      Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis~     of pneumonia in febrile neutropenic patients and it is significantly superior to~     conventional chest X-ray. However, the method is associated with some difficulties mostly~     due to the broad spectrum of pathological findings in patients with IPA and their evolution~     over time. This has been described in retrospective studies on relatively small groups of~     patients. Prospective studies on larger populations are still missing, as well as studies on~     combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.~      We recently published the results of the clinical trial: A Phase II Dose Escalation Study~     of Caspofungin in Patients with Invasive Aspergillosis which used caspofungin doses of 70~     to 200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not~     reached, but response rates were impressive with complete plus partial responses accounting~     for 54.3% and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency~     towards higher doses yielding higher response rates.~      For the majority of these patients we obtained serial chest CT. So, for the first time a~     patient population is at hand, in which the kinetics of infiltrates over time can be~     described.~      The main objective is to describe the pathological findings in chest CT performed~     sequentially in IPA patients while receiving effective antifungal therapy. The specific~     objectives are:~        1. Characteristics of pathological findings in sequential chest CTs~             -  To describe the pathological findings (e.g. halo sign, air crescent sign and air~               consolidation) in sequential high resolution computed tomogrphy (HRCT)~               examinations~             -  To calculate the incidence of individual pathological findings in sequential CT~               examinations~             -  To calculate a total volume of fungal infiltrates in sequential CT examinations~        2. Correlation of pathological findings in sequential CT with corresponding white blood~          count (WBC) and absolute neutrophil count (ANC)~             -  To correlate the appearance or disappearance of individual pathological findings~               with WBC and ANC~             -  To correlate the volume of fungal infiltrates in sequential CT examinations with~               WBC and absolute neutrophil count~        3. Correlation of pathological findings in sequential CT with the serum galactomannan~          index~             -  To correlate the appearance or disappearance of individual pathological findings~               with the serum galactomannan index~             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with~               the serum galactomannan index~        4. Correlation of pathological findings in sequential HRCT with outcome of IFI~             -  To correlate the appearance or disappearance of individual pathological findings~               with outcome of IFI~             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with~               outcome of IFI~   "
21981|NCT02769468|"~     The aim of the study is to compare the effect of 3 different skin temperature placement~     probe in the case room on the admission temperature to the NICU in preterm infants. The~     authors aim to evaluate which placement results in more preterm in the acceptable range~     (36.5-37 °C).~   "
21687|NCT02773329|"~     Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in~     sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural~     control and high fall risk. This study will investigate the acceptability and effect of an~     interactive motor adaptation balance training program based on wearable sensors for~     improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN~     will be recruited and will be randomized to either intervention (IG) or control (CG) group~     and followed for 6 months. The intervention group will take part in a 6-week balance~     training program twice per week in either their home or in clinic (based on subject~     preference) under the supervision of a qualified research staff member. This intervention~     includes interactive game-based balance training including repetitive weight shifting and~     virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory~     feedback from foot and ankle position and allowed perception of motor-errors during each~     motor-action. The control group will be instructed to complete a supervised foot and ankle~     exercise without using sensor technology. Changes in balance, gait, and physical activity,~     and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month~     post intervention. Investigators hypothesize that patients receiving sensor-based exercise~     training will benefit more compared to group receiving conventional non-technology~     home-based training in terms of improving functional performance and reducing falls.~   "
21688|NCT02773316|"~     A study to assess bioavailability of a single dose of MR902 and to assess the effect of food~     on absorption~   "
21689|NCT02773303|"~     This project aims:~        -  to further explore the effectiveness of a novel sonified Neurofeedback management~          therapy for children diagnosed with Autism Spectrum Disorder (ASD)~        -  to determine if balance control is different before and after therapy~   "
21690|NCT02773290|"~     The objective of this study is to evaluate the efficacy of romiplostim administered once~     weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible~     for immunosuppressive therapy in Japan and Korea.~      Safety and pharmacokinetics of romiplostim after repeated administration will also be~     assessed.~   "
21691|NCT02773277|"~     Due to its localization in the cerebello-pontine angle, the vestibulo-cochlear nerve is at~     risk to damage during surgery performed nearby. In most cases, peripheral-cochleovestibular~     hypofunction recovers over the following weeks as the mechanism of damage is rather~     demyelination than axonal damage. The rate, intensity and extent of recovery of such~     perioperative peripheral-vestibular damage is not known.~   "
21692|NCT02773264|"~     This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography~     of Patients referred to our institution to assess soft tissue and organ lesions. All~     patients will undergo next to the clinical indicated conventional US-examination, US~     Elastography after informed consent. After completion of these three examinations, the~     participation in the study is completed.~   "
21693|NCT02773251|"~     To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose~     following laparoscopic pelvic surgery (radical prostatectomy).~   "
21694|NCT02773238|"~     This phase II trial studies how well positron emission tomography (PET)/computed tomography~     (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving~     radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer.~     PET/CT imaging mid-way through treatment may be able to accurately show how well radiation~     therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of~     the lung tissue are healthier than others. Based on the result of the imaging, treatment~     adjustments may be made to the radiation therapy to improve survival and decrease toxicity.~   "
21695|NCT02773225|"~     The aim of this study is to improve treatment of Moderate Aplastic Anemia (MAA) by~     evaluating the safety and efficiency of Eltrombopag as a new treatment option in patients~     with therapy requiring MAA.~   "
21696|NCT02773212|"~     The purpose of this study is to examine anhedonia as a potential moderator of treatment~     outcomes for Cocaine Use Disorder (CUD). Specifically, this study will investigate how~     anhedonia affects outcomes in contingency management (CM) treatment for CUD and whether~     anhedonia mediates the effects of adjunctive treatment with a dopaminergic (DAergic) drug,~     d-amphetamine, on outcomes in CM for CUD, as well as investigate the contribution of~     anhedonia to overall CUD severity.~   "
21697|NCT02773199|"~     This study compares differences in hemodynamic ve ECG parameters of patients undergoing~     urological or orthopedic surgery under spinal anesthesia. First group will comprise of~     patients undergoing surgery in the morning hours; thus with a standard fasting duration (8~     hours), and the second group will comprise of patients undergoing surgery afternoon; thus~     having a prolonged fasting duration (>12 hours).~   "
21698|NCT02773186|"~     The main objective of the present study was to evaluate whether cerebral oxygen saturation~     is associated with an increase of NPOBC in pediatric patients undergoing major surgery.~   "
21699|NCT02773173|"~     The purpose of this study is to assess the post-operative recovery quality of the~     Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus~     standard therapy using a quality validated scale of postoperative recovery of their stay in~     the Post-Anaesthesia Recovery Unit.~   "
21700|NCT02773160|"~     A large subgroup of patients with chronic non-specific low back pain have motor control~     impairments. During motor control exercises, different forms of external feedback can be~     used to support training. This randomized controlled trial will investigate the~     effectiveness of different forms of external feedback during the learning phase of a motor~     control task for the lumbar spine in healthy subjects and patients with chronic non-specific~     low back pain (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized~     into three groups: one group will receive feedback from motion sensors, one group from a~     mirror and one group will receive no feedback (control group). A single session intervention~     with measurements at baseline and immediately post-intervention will be used.~   "
21701|NCT02773147|"~     The purpose of this study is to investigate if B vitamin substitution have effect on NFL~     (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected~     individuals with increased plasma homocysteine~   "
21780|NCT02772107|"~     Temozolomide may delay progression in sequence with chemotherapy. This open-label,~     randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide~     following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly~     diagnosed estensive-stage SCLC.~   "
21702|NCT02773134|"~     Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients~     with lumbar degenerative conditions with the aim of improving pain relief and quality of~     life. However, there is a lack of evidence on the indication for postoperative bracing, as~     surgeons choose to use braces mainly based on their experience and training.~      The aim of this study is to investigate whether wearing a brace after PSIF can improve pain~     relief and quality of life (QOL) 6 weeks and 3 months after surgery.~   "
21703|NCT02773121|"~     The goal of this research study is to examine whether an intervention to increase physical~     activity using a body-worn sensor affects cognitive (thinking) processes.~   "
21704|NCT02773108|"~     Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric~     hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic~     comorbidities in psychiatric patients population and the general Croatian population.~   "
21705|NCT02773095|"~     Countries throughout the world are facing a growing non-communicable disease (NCD) burden.~     In developing countries, medicines to treat NCDs are often difficult to access or too~     expensive for many households. Novartis/Sandoz has recently launched Novartis Access, an~     initiative to subsidize a basket of NCD medicines sold to purchasers in program countries~     and delivered through the public and non-profit health sectors. This study will evaluate the~     impact of Novartis Access on the availability and price of NCD medicines at health~     facilities and households in Kenya, the first country to receive the program.~   "
21706|NCT02773082|"~     There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive~     behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the~     alternative approach or a combination of the two. A rarely used third therapy approach,~     appropriate for only the most severely afflicted and treatment resistant patients, is~     neurosurgical ablation of certain brain regions involved in mood and anxiety. The~     neurosurgical ablation procedures are irreversible in nature, and involve the destruction of~     specific volumes of brain tissue through various controlled means.~      Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a~     combination of the first two procedures and capsulotomy. DBS therapy is an alternative to~     neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic,~     severe OCD which has proven resistant to primary pharmacological and/or behavior therapy~     options.~      Results from 26 severe, treatment-resistant OCD patients treated with DBS at four~     collaborating centers, three in the US, and one in Europe are summarized in great detail in~     pages 12-22 of the provided/attached Reclaim Summary of Safety and Probable Benefit.~   "
21707|NCT02773069|"~     The proposed Church Bridge intervention project will provide an innovative, evidence-based~     and technology supported, health intervention model for Southern, African American, and~     rural populations who continue to be disparately burdened by obesity and associated~     co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young~     adults (21-50 years of age) with families, the project will contribute to the long-term~     reduction of preventable chronic disease and related health care costs for the public.~   "
21708|NCT02773056|"~     The primary objective of this clinical trial is to determine if the Dynamic Socket and~     Sub-Ischial alternative interface designs improve socket comfort, residual limb health,~     increase function and be preferred over the standard of care Ischial Ramus Containment (IRC)~     interface for the military and veteran living with transfemoral limb loss.~   "
21709|NCT02773043|"~     The proposed study is to validate a non-invasive imaging technique to evaluate the~     myocardial perfusion reserve in comparison with a validated invasive technique, the measure~     of coronary flow reserve (CRF) with thermodilution.~   "
21710|NCT02773030|"~     This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to~     determine the maximum tolerated dose of CC-220 when administered as monotherapy and in~     combination with dexamethasone. The study will consist of an escalating dose-escalation~     portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT)~     and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose~     (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).~   "
21711|NCT02773017|"~     Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and~     inhibition of sympathetic nerves and other effects. Because of its minimal impact on the~     respiratory , currently it was more and more widely used to sedate patients undergoing~     regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected~     by age, and current studies with regard to the effects of age on dexmedetomidine~     pharmacodynamic are rare. This study was designed to explore the right DEX dose of different~     female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with~     combined spinal and epidural anesthesia for sedation,which is monitored by the~     Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of~     sedation for patients is also investigated.~   "
21712|NCT02773004|"~     The trial population of this study is composed of women aged more than 18, who have~     developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative~     invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using~     standard assessments.~      Obtaining material for test is at no risk as done from the surgery material. Tumor molecular~     EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast~     cancer related genes and will provide important prognosis indications. Clinical validation~     studies have demonstrated that molecular assays are useful for stratifying patients into~     risk categories and helpful in making clinical treatment decisions in ER+/node-negative~     breast cancer patients.~   "
21713|NCT02772991|"~     In recent years, a large number of studies have been conducted on how to improve the~     treatment of patients in the Emergency Room (ER) complaining of chest pains. Great advances~     have been achieved recently regarding diagnostic methods aided by coronary CT angiopraphy~     (CCTA) and high-sensitive troponins. However, various questions about these methods still~     remain obscure and there is no effective comparison between them in patients with~     intermediate risk. The aim of the study is to evaluate the sensitivity and specificity of~     high sensitivity troponins in the detection of coronary artery disease in patients with~     chest pain and the intermediate probability of ACS compared with CCTA.~   "
22022|NCT02768935|"~     The prevalence of type 2 diabetes is growing steadily. Patients with diabetes,~     cardiovascular complications (such as myocardial infarction (MI)) are more frequent and~     severe than in non-diabetic subjects. The anti-diabetic therapies available have little or~     no effect on the incidence of cardiovascular events. It is therefore urgent in diabetics~     develop new therapeutic strategies to reduce the occurrence of MI or limit the consequences.~      In the two weeks following MI, monocytes / macrophages are the most represented in the~     ischemic heart tissue cells. The infiltration by monocytes / macrophages after infarction MI~     is a two-phase process. In the first phase, monocytes / macrophages M1 promote digestion~     injured areas, and monocytes / macrophages M2 intervene to promote angiogenesis, collagen~     deposition and contribute to tissue repair. The optimal repair after myocardial infarction~     depends on effective recruitment of monocytes and macrophages M1 transition needed to digest~     the damaged tissue and M2 macrophages necessary for tissue repair. The balance between these~     two phenotypes M1 and M2 is controlled by different modulators, such as transcription~     factors, cellular miRNA and miRNA extracellular contained in the microvesicles (MVs).~     Interestingly, plasma MVs circulating essentially derived monocytes and platelets contain~     miRNA and are impaired by inflammation or during various pathological situations (such as~     IDM). Furthermore, metabolic disorders such as hypercholesterolemia (often associated with~     diabetes) affect the transition from M1 to M2 response and response delay cardiac repair. To~     date, the mechanisms that control the M1 / M2 transition at heart level are not elucidated.~     Moreover, the impact of diabetes, which leads to chronic low-grade inflammation, is not~     explored. Targeting the immune response by promoting the transition M1 / M2 after MI could~     be an innovative therapeutic approach. However, better characterization of the response of~     M1 and M2 macrophages after MI and the mechanisms by which they contribute to tissue~     remodeling and the effect of diabetes are needed. The goal is to study how the phenotypes /~     macrophage functions after MI are changed by diabetes and to determine the potential role of~     miRNAs contained in secreted MVs in the transition M1 / M2 after MI.~      Monocytes / macrophages from subjects with normal blood sugar or diabetes who underwent an~     IDM (10 per group) will be characterized phenotypically. Their ability to produce MVs will~     be analyzed. These MVs will be tested functionally for their ability to orient the~     polarization of healthy recipients monocytes. The content of these MVs in terms of miRNAs~     will be analyzed in detail. By bioinformatics analysis, some miRNAs of interest (based on~     their abundance and target genes) will be selected. These miRNAs are over-expressed in~     macrophages and MVs produced by these cells will be analyzed for their ability to modulate~     differentiation of monocytes recipients. Finally, the circulating levels of these miRNAs of~     interest will be measured after 1 year of IDM and will be correlated to the clinical~     phenotype of patients (recurrence, arrhythmias, heart failure). Ultimately, the goal is to~     identify VMs that can promote the differentiation of monocytes to an alternative phenotype~     and identify miRNAs responsible for this effect. This could help in the future, in a subject~     with impaired ability of monocytes to differentiate alternatively, can change by introducing~     the miRNA of interest to re-inject or inject MVs macrophage containing the miRNA of interest~     and thus correct the defect of differentiation.~   "
21716|NCT02772952|"~     Objective: To compare short-term and medium-term effectiveness of a multimodal program that~     integrates a program of therapeutic exercise, medication review, adequacy of diet and health~     education, compared with standard medical practice in improving neuromuscular and~     physiological status on frail elderly. Another aim is to analyze the maintenance of these~     effects by monitoring long-term (12 months) from the start of the intervention.~      Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic~     Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting~     inclusion / exclusion) will be randomized into two groups: a control group whose~     intervention will be to review medication + adequacy of diet + health education (physical~     activity recommendation (within a comprehensive advice on healthy lifestyles) and an~     experimental group whose intervention will be a Multimodal Intervention: therapeutic~     exercise + review medication + adequacy of diet + health education program.~      Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover,~     tracking variables will be collected at 2 and 6 months after starting the intervention and~     at 3 and 6 months after the end of the intervention (monitoring).~      The monitoring variables that will be measured are: BMI , general health, fatigue,~     brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial~     orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and~     metabolomic variables.~      One descriptive analysis of the sociodemographic variables of the participants will be~     performed. Further the change on the variables intra-subjects (pre-post intervention) and~     inter-subjects (experimental group vs control group) will be calculated. For the~     intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject~     outcome variables will be compared between the two groups in each moments of data~     collection, using the student t-test or Wilconxon (depending of the sample distribution).~     The level of significance was set at P ≤ 0.05.~   "
21717|NCT02772939|"~     This trial is designed to establish invasive and non-invasive measures of arterial stiffness~     as potential predictors of treatment response to renal sympathetic denervation~   "
21718|NCT02772926|"~     Several mechanisms have been implicated in the pathophysiology of the complications of~     diabetes mellitus (DM), one of them is the formation and accumulation of a heterogeneous~     group of compounds called advanced glycation end products (AGEs). The interaction of these~     compounds with their receptor, the receptor for advanced glycation end products (RAGE)~     triggers several signalling pathways which will lead to increase in inflammatory molecules~     and enhanced reactive oxygen species. In addition, to the membrane receptor RAGE, there are~     two soluble forms, the soluble RAGE (sRAGE) and the endogenous secretory RAGE (esRAGE),~     these soluble receptors are capable to bind AGEs and block the AGE-RAGE axis. It has been~     observed that in diabetes the needs of thiamine are increased, and it could be an inhibition~     of the pentose phosphate pathway (thiamine is an essential cofactor in this pathway) and~     activation of other metabolic pathways among them AGEs formation. It has been proposed that~     supplementation of benfotiamine could decreased the risk of micro and macrovascular~     complications, and this could be in part because a decreased in the formation of AGEs. For~     this reason, the objective of this study was to evaluate the effect of benfotiamine on AGEs~     and its soluble receptors (sRAGE) in patients with type 2 diabetes.~      The specific objectives in the current study are:~        1. To evaluate and compare clinical and anthropometric characteristics in type 2 DM~          patients with and without benfotiamine treatment.~        2. To evaluate and compare in type 2 DM patients with and without benfotiamine treatment~          the following biochemical parameters: total AGEs, Carboxymethyl-lysine (CML), sRAGE,~          glucose, hemoglobin A1c, lipids (total cholesterol, C-HDL, C-LDL, and triglycerides).~        3. To evaluate and compare dietary data such as dietary AGEs and macro and macronutrients~          in type 2 DM patients with and without benfotiamine treatment.~      Type of study: This is a randomized, controlled, double-blind clinical trial~      Methods 34 patients will be recruited, 17 per group. After signing the inform consent~     subjects will be assessed for inclusion criteria. Subjects meeting the inclusion criteria~     and those whom accept to participate will be randomized to receive either a placebo or~     benfotiamine treatment for 12 weeks.~      At the end of the 12 weeks all the basal assessments will be repeated.~   "
21719|NCT02772913|"~     Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if~     unrecognized early. This multicenter retrospective observational study will review the~     emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis~     of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for~     abdominal pain in the same timeframe.~   "
21720|NCT02772900|"~     Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial~     dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased~     NO bioconversion, which may promote beneficial effects on vascular health. The present study~     evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function,~     arterial stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly~     individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial~     flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ),~     augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep),~     arterial compliance (AC), muscle oxygenation and function were measured 90 min after~     interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood~     pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after~     interventions.~   "
21721|NCT02772887|"~     The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks~     provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma~     L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of~     placental growth factor (PlGF).~   "
21722|NCT02772874|"~     Fecal incontinence (FI) is clinically subtyped as urge FI and passive FI based on symptoms,~     however the pathophysiologic significance of this subtyping is not known. FI is commonly~     encountered in women with pelvic floor disorders. This study aims to compare characteristics~     of clinical severity, quality of life, anatomy, and physiology of urge FI versus passive FI.~     Urogynecology patients greater than age 18 with FI at least monthly over the last 3 months~     will be recruited for participation. Participants will be divided into urge FI subtype and~     passive FI subtype. Participants will complete validated questionnaires on clinical severity~     and quality of life, both as related to FI and general heath. Participants will undergo~     pelvic examination, endoanal ultrasound and anorectal manometry for evaluation of anatomic~     and physiologic pathology. Results between both groups will be compared. The investigators~     hypothesize that clinical, anatomic, and physiologic characteristics differ between~     urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with~     pelvic floor disorders.~   "
21723|NCT02772861|"~     There are many forms of small bowel disease but their direct consequences on small bowel~     function are often very hard, if not impossible, to establish. It would be helpful if there~     was a reliable blood test to find out how well cells in the intestine are working. The amino~     acid citrulline is produced mainly by these cells, and therefore holds promise as a~     biological marker. Some previous studies have shown that fasting citrulline gave a good~     indication as to how many intestinal cells were present. However, other authors have not~     been able to confirm this.~      Most of the citrulline in the blood is derived from another amino acid, glutamine, in a~     metabolic process that occurs in the intestinal cells, and most of the remainder comes from~     another amino acid, arginine. A further potential marker of intestinal cell function is the~     amino acid 3-methylhistidine. It is possible that a dynamic test, which incorporates time~     for conversion from one amino acid to another in the intestinal cells, might perform better.~      The investigators therefore propose a study of oral glutamine, arginine, and~     3-methylhistidine compared with citrulline itself or placebo (glucose) as it is hypothesized~     that these might increase the amount of citrulline more reproducibly. An initial study in~     healthy subjects is required to establish whether this is true, and if so to provide a~     normal range prior to investigation of patients who have or who might have the short bowel~     syndrome, and in whom the test would be clinically useful.~      In this study, the subjects will take each of the amino acids and placebo in random order.~     Between each 6 hour-long visit the subjects will have at least one week where they are~     independent of the research team and during which they can behave normally. During each~     visit subjects will have a sequence of blood samples from an in-dwelling venous cannula,~     taken before and over 6 hours after a single small oral dose of that day's amino acid given~     as a small volume drink. Urine will also be collected for amino acid assay.~   "
21724|NCT02772848|"~     The study objectives are described below:~        1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but~          not to exceed a total of 550 ml of whole blood per subject from a minimum of 60~          healthy, premenopausal subjects. Specimens will be used to determine a reference range~          for estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of~          fertility in adult, premenopausal women.~        2. To store any remaining specimens for use in future assay development and to evaluate as~          yet undetermined assays for the development of IVDs, including additional estradiol,~          FSH, LH, and progesterone assays.~   "
21725|NCT02772835|"~     The purpose of this study is to compare the effects of two different techniques of~     non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering~     from respiratory distress syndrome.~   "
21726|NCT02772822|"~     The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus~     Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.~      The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well~     as the presence of human anti-chimeric antibodies (HACA).~   "
21727|NCT02772809|"~     Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked~     to perform a battery of assessments to test the viability and usability of a force-feedback~     robot that adapts to each individual subject's performance. Subsequently, they will be asked~     to complete post-assessment questionnaires that provide feedback to the researchers on their~     observations and thoughts about the therapy devices.~   "
21728|NCT02772796|"~     This study is to aid the development for the use of SENS-218 outside its marketed~     therapeutic indications. SENS-218 is available in Asia and is marketed as an anti-emetic~     (Anti-sickness) drug often prescribed after exposure to chemotherapy. Chemotherapy exposure~     can often induce nausea and/or vomiting.~      The study only involves the one drug, referred to as SENS-218 in this study. The purpose of~     the study is to support the development of use of SENS-218 in non-Asian population.~      The key objective of this study is to identify the pharmacokinetic (PK) parameters of the~     drug in healthy Caucasian population. The PK refers to what the body does to the body, for~     example, how quickly the drug is absorbed into the blood stream.~      The population who are eligible to take part in the study are healthy male and female,~     non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at~     Simbec.~      Participation in the trial will last for about 3 weeks (from first screening visit to final~     end of study visit).~   "
21729|NCT02772783|"~     Processed carbohydrates cause rapid changes in blood sugar and have been associated with~     overeating and obesity. We have shown that test meals high in processed carbohydrate affect~     brain areas involved in addiction, craving and overeating. It is unknown whether the changes~     in blood sugar or the associated higher insulin levels mediate this brain activation and its~     likely adverse effects.~      Answering this question is important for patients with type 1 diabetes who have elevated~     risks of obesity and disordered eating: If blood sugar is the causal mechanism, optimal~     insulin coverage should be protective. If insulin is the causal mechanism, however, a diet~     high in processed carbohydrate could predispose to overeating and weight gain, as this diet~     requires higher insulin doses.~      To disentangle these factors, we will study brain activation and relevant blood markers in~     15 men with diabetes. In 4 sessions, we will examine meals with differential carbohydrate~     properties while giving insulin infusions.~   "
21730|NCT02772770|"~     Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective~     cohort study. Specific aims of PLUTO are to evaluate the safety and comparative~     effectiveness of non-operative treatment, as well as four operative treatments including (1)~     transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3)~     physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4)~     physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and~     pubescent skeletally immature patients.~   "
21731|NCT02772757|"~     The overall aim of the study is to compare the verification accuracy and hearing-aid~     outcomes between the traditional, fitting approach where the patient is present during the~     visit and a coupler-based fitting approach where the patient is not present and mailed their~     hearing aids. If the coupler-based fitting protocol tested in this study as effective as the~     traditional fitting protocol, then patients receiving replacement hearing aids may~     circumvent a face-to-face visit.~   "
21732|NCT02772744|"~     This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From~     June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus~     genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of~     Egyptian ministry of health and population. The primary outcomes are safety of the treatment~     and the sustained virologic response 12 weeks after discontinuation of therapy. For the~     secondary outcomes, investigators will measure the change in health related quality of life~     and investigate the genetic sequence of viral RNA of resistant patients.~   "
21733|NCT02772731|"~     Breast cancer is the most common malignancy affecting women in the US. Surgical management~     is the mainstay of therapy, and in general consists of resection of the primary tumor with~     either a partial mastectomy (aka lumpectomy) or a total mastectomy.~      The investigators hypothesize that routine shave margins during partial mastectomy will~     significantly reduce positive margin rate. A positive margin means that cancerous cells were~     detected at the edge of the excised area. This generally mandates a return to the operating~     room for re-excision.~   "
21734|NCT02772718|"~     The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in~     patients with hypoglycemia after gastric bypass surgery.~   "
21735|NCT02772705|"~     The purpose of this study is to find out the capacity of standardized uptake value (SUV)~     using single-photo emission computed tomography and computed tomography (SPECT/CT) in~     diagnosing Grave's Disease (hyperthyroidism).~   "
21736|NCT02772692|"~     Whether functional consumption is influenced by defecation postures is unclear. The~     investigators investigated effects of defecation postures on functional consumption.~   "
21737|NCT02772679|"~     The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in~     patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.~   "
30934|NCT02652182|"~     The aim of this study is to investigate whether or not short-term expose to air pollution is~     associated with in-hospital outcomes, such as mortality and morbidity.~   "
21738|NCT02772666|"~     This study is to evaluate the ability of a newly designed device, Optic Nerve Glass~     (O-Glass) to detect relative afferent pupillary defect (RAPD). In this prospective study, 44~     patients (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by~     O-Glass and also manual swinging flashlight method (SFM) . This newly designed instrument~     captures and records eye pictures. The images will be processed and analyzed using~     computerized software to calculate pupillary measurements.~   "
21739|NCT02772653|"~     Severe trauma patients have an elevated risk of multiple organ failure and death. In order~     to increase survival possibilities the initial treatment must be focused into resuscitation~     from shock. Traditionally the most common resuscitation markers used are vital signs and~     urine output. Unfortunately, many patients might present normal vital signs, but still~     undergo a compensated shock with persistent acidosis, hence being able to develop multiple~     organ failure and death. Consequently, it is important to define better resuscitation~     markers for these patients.~      This investigation project consists in an observational prospective study, performed by a~     multidisciplinary team, in which different resuscitation markers are evaluated in severe~     trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival)~     evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical~     (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS);~     microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry).~     There will be a registry of total volume administration; blood cell transfusions and~     vasoactive drug requirements. Each marker will be evaluated in relation to mortality;~     multiple organ failure; massive transfusion protocol activation; blood cell transfusion~     requirement; surgical control of bleeding requirement and emergent arteriographic~     embolization. The objective of this study is to demonstrate which of these markers is better~     to predict hemodynamic evolution of severe trauma patients and might become a guide for~     resuscitation in the future.~   "
21740|NCT02772640|"~     The aim of the study is to demonstrate, whether the time of day of administration of the~     study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of~     lipid-lowering therapy.~   "
21741|NCT02772627|"~     The purpose of this study is to investigate the tolerability and safety of three multiple~     dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy~     volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition~     profiles of nebicapone in healthy volunteers.~   "
21742|NCT02772614|"~     The purpose of this study is:~      To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and~     faeces To determine the kinetics of total radioactivity in blood To determine the kinetics~     of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites~     in plasma~   "
21743|NCT02772601|"~     To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as~     a means of predicting drug-drug interactions.~   "
21744|NCT02772588|"~     The purpose of this study is to determine whether anti-testosterone medications, when~     administered before, during, and after high-dose, precision radiation, will be effective in~     preventing the prostate cancer from returning.~   "
21745|NCT02772575|"~     The purpose of this study is to see if certain genes the tumor can help predict how the~     tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and~     functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the~     hereditary material in humans. Identifying a gene that can predict how liver tumors will~     respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.~   "
21746|NCT02772562|"~     The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer~     from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.~   "
21747|NCT02772549|"~     Patients with newly diagnosed IPF are investigated for the diagnostic delay before a~     diagnosis of IPF is made.~   "
21748|NCT02772536|"~     Background~      An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that~     viewing particular tints of light appeared to result in some improvement of their tinnitus.~      This ameliorative effect appeared to be primarily acute and only reported to occur whilst~     viewing the tint. Individual patients would choose differing tints with some identifying~     more than one tint that affected their tinnitus.~      Aim of the Study~      In this current basic science study, the aim is to provide preliminary data to return~     estimates of the efficacy of using tinted light to ameliorate tinnitus.~      After identification of responders during screening, responders are invited to attend three~     further trial sessions, where their tinnitus is assessed in response to three luminance~     conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.~      The response to low ambient light serves as a control to compare the effect of tinted light~     against and the response to white light serves as an 'active' stimulus comparator.~      These results will then establish whether tinted light provides patients with a useful~     improvement in their tinnitus compared with measures of their baseline tinnitus obtained in~     the dark and against a standardised white light stimulus.~      They will also inform further development of the technique as a potential treatment for~     tinnitus in responsive patients.~      Over the three sessions, the averaged responses given by the patient under each stimulus~     condition will be analysed to provide a measure of efficacy.~   "
21749|NCT02772523|"~     Recent epidemiologic studies are identifying a number of modifiable risk and protective~     factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the~     combination of an early detection of individuals at risk together with interventional~     studies targeted to the control of modifiable risk factors makes primary prevention~     programmes to become a new and real therapeutic strategy.~      In this scenario, the investigators have designed the ALFAlife study, a programme of control~     and intervention on the modifiable AD risk factors. Throughout this study, participants will~     be given a number of healthy lifestyle guidelines that are personalised depending on their~     specific risk profile. These guidelines refer to smoking and dietary habits and physical,~     cognitive and social activity. The investigators hypothesis is that the follow-up of these~     guidelines will favor a change of participants' lifestyle habits towards healthier ones. In~     addition, the investigators hypothesise that changes in these lifestyle habits will have an~     effect on objective physiological measures (such as blood pressure and cholesterol levels).~   "
21752|NCT02772484|"~     The HS-1000 device, an investigational intracranial monitoring device, has the potential to~     safely and quickly diagnose and assess stroke (and potentially other neurologic conditions)~     with minimal discomfort to patients. HS-1000 has the capability to establish cerebral~     hemodynamic measurements in suspected stroke within minutes, assist with appropriate~     management of stroke, and also provide an objective diagnostic tool for clinicians to~     monitor recovery.~   "
21753|NCT02772471|"~     Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal~     pressure transducer or external ventricular drain (EVD), provides an ICP waveform that~     encapsulates valuable diagnostic and monitoring clinical information.~      HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP~     waveform safely and accurately with minimal discomfort to patients, compared to standard~     invasive ICP monitoring procedures used at the participating institutions.~   "
21754|NCT02772458|"~     Crohn's disease (CD) is becoming more common, specifically in the western world. One of the~     main features of this disease is weight loss and malnutrition. Although clinically common,~     these problems are not well understood. Loss of appetite and symptoms such as tummy aches~     and bloating are common causes for weight loss in this group of patients. This problem has a~     strong negative effect on the patients' quality of life and significantly increases the cost~     of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the~     brain to control food intake. Recent evidence has showed that these cells increase in number~     in active CD and secrete more hormones that negatively affect appetite. The increased levels~     of these hormones should have an overall negative effect on the brain and thus decrease food~     intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are~     hypotheses that require further proof. Current technological advances in magnetic resonance~     imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain~     that control food intake. The involvement of the brain in control of food intake is still~     not fully understood. This work will be the first step in the right direction to start~     targeting the problems of appetite, weight loss and a poor quality of life.~   "
21755|NCT02772445|"~     The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in~     caregiver and care-recipient outcomes~   "
21756|NCT02772432|"~     This study has three aims:~      Phase I: Through focus group interviews with expert clinicians, leaders of organizations,~     and parents with children with special needs, this study aims to identify the psychosocial~     needs of parents of children with learning disabilities, specifically a) the types of~     concerns that parents find most difficult and stressful b) areas of concern that lack~     support and resources, and c) areas of need for education and skill training. This study~     also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency~     Program (3RP).~      Phase II: Informed by Phase I findings, this study aims to develop and determine the~     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)~     program for parents of children with Specific Learning Disabilities (SPLD).~      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,~     establishing efficacy of a virtual resiliency program.~   "
21757|NCT02772419|"~     The objective of this study is to evaluate the efficacy and safety of SC administrations of~     Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a~     multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and~     immunogenicity will be assessed secondarily.~   "
21758|NCT02772406|"~     The purpose of the study is to determine whether a new colonoscopic viewing technique called~     Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative~     colitis patients than conventional colonoscopy using white light alone.~   "
21759|NCT02772380|"~     The main purpose of this clinical study is to collect electrograms from an investigational~     lead placed in an extravascular space, for development of a future Implantable Cardioverter~     Defibrillator (ICD) system.~   "
21760|NCT02772367|"~     The purpose of this study is to investigate whether cells from a biopsy taken from the~     patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart~     muscle cells) when grown in a special culture medium outside of the body. The structure and~     function of these cells will then be studied to determine why some patients with breast~     cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and~     anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.~   "
21761|NCT02772354|"~     To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs~     in the pediatric population as first-line therapy compared with antiarrhythmic drugs.~   "
21762|NCT02772341|"~     Background: Asthma is a chronic inflammatory disorder requiring intermittent or continuous~     anti-inflammatory therapy. Patients often turn to alternative treatments as complements or~     replacements to conventional treatments.~      Aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper-~     responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in~     children with asthma.~      Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving~     anti-inflammatory therapy.~      Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt~     room therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire~     (PAQLQ). The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without~     salt halogenerator.~   "
21763|NCT02772328|"~     The purpose of this study is to test an intervention designed to train persons who inject~     drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1)~     promote new HCV treatment and care 2) risk reduction and 3) recruit their social network~     members for HIV and HCV testing and linkage to care.~   "
21764|NCT02772315|"~     The purpose of this study is to assess the validity and usefulness of omics signatures for~     improved identification and risk stratification of patients with endocrine hypertension and~     stratification of patients with primary hypertension.~   "
21791|NCT02771964|"~     This study will compare two commonly-used methods for assessing patient-reported quality of~     life. The first is to assess quality of life before surgery and again after surgery using~     the same validated scale (ie Veterans Rand 12). The second is simply to ask patients whether~     or not they think their post-operative quality of life is better, worse, or the same. The~     investigators hypothesize that the second method may be inaccurate due to cognitive bias.~   "
21765|NCT02772302|"~     The primary aims of this study are:~        1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based~          system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or~          locked-in syndrome (LIS);~        2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate~          with bedside behavioral assessments of consciousness;~        3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate~          with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of~          consciousness;~        4. To determine if mindBEAGLE can serve as an assistive communication device for people~          with LIS.~   "
21766|NCT02772289|"~     The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem~     cells treatment on the appearance of a caesarean scar as compared to a similar untreated~     scar.~   "
21767|NCT02772276|"~     This study is a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the~     use of the non-invasive optical renal function monitor (ORFM) device in normal and~     compromised renal function participants with different skin color types.~   "
21768|NCT02772263|"~     Older adults living in subsidized housing report poorer health. Their low income and age~     make it harder for them to use community services. Many older adults have heart disease and~     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the~     costs of treating heart disease and diabetes through emergency and hospitalization, improved~     screening and health education is needed. The Community Health Assessment Program through~     Emergency Medical Services (CHAP-EMS) program will take place in communal areas within~     housing buildings of older adults and deliver a heart disease, diabetes, and falls risk~     check-up with health education. This is expected to improve the health of older adults~     leading to fewer emergency calls and hospital visits.~      Paramedics on modified duties (e.g. injured) will conduct weekly, one-on-one drop-in~     sessions for seniors in a common area of one subsidized apartment building in Hamilton,~     Ontario.~   "
21769|NCT02772250|"~     The study compares the efficacy of bowel preparation between the face-to-face~     re-education(FFRE group) and normal education (no-FFRE group) in patients.~   "
21770|NCT02772237|"~     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the~     duration of time for a student-athlete to return to participation in sports after a sports~     related concussion.~   "
21771|NCT02772224|"~     Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of~     below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty~     (BA).~   "
21772|NCT02772211|"~     This is a two-stage experiment; the first stage is an open label trial in which participants~     receive six intravenous (IV) treatments of ketamine. The second stage includes participants~     that responded to ketamine (i.e. reduction of 25% in their symptoms of depression, as~     measured by the Montgomery Asberg Depression Scale MADRS). The second stage is a~     double-blind, controlled clinical trial of D-cycloserine (DCS) vs. placebo, as maintenance~     treatment in patients who responded to ketamine treatment. The aim of the study is to~     determine whether 8 weeks of DCS maintenance therapy will prevent relapse of depressive~     symptoms following ketamine infusions~   "
21773|NCT02772198|"~     This phase 1 / 2 study will evaluate the response of B-cell malignancies expressing CD19 to~     autologous T cells transduced with a second generation anti-CD19 chimeric antigen receptor~     in children and young adults.~   "
21774|NCT02772185|"~     This study is a double blind, sham-controlled clinical trial aiming to compare the long-term~     effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part~     in a phase II/III clinical study over a 1-year period. The study involves transcranial~     direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and~     neurological testing. These assessments will occur at baseline, then again at two month (end~     point). Those who achieve clinical improvement with neurostimulation and cognitive therapy~     will be invited to receive treatment for 12 months as part of a follow-up study.~   "
21775|NCT02772172|"~     The main purpose of the present study is to evaluate the dental implant placement using two~     different CBCT-derived templates and to study the related factors that affect accuracy so as~     to support the further clinical application of the technique. Thirty patients with partial~     edentulous denture are recruited. They are randomized to two groups. A radiographic guide is~     prepared before CT/CBCT scan. The CT/CBCT scan DICOM ﬁles are loaded in a planning program~     and converted into 3D computer images. A surgical template is fabricated through this~     virtual planning. After 6 weeks, if the implants are judged stable, the patient has the~     option of replacing the ﬁxed prosthesis. Patients are recalled for oral hygiene maintenance~     and prosthetic controls every 6 months for the entire duration of the study.~   "
21776|NCT02772159|"~     The purpose of this study is to evaluate the absorption, distribution, metabolism and~     excretion of an investigational medication used to treat chronic obstructive pulmonary~     disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include~     a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be~     a 28 day washout period between each of the 2 dosing routes.~   "
21777|NCT02772146|"~     A single-center, prospective, non-randomized, clinical and first-in-human study. Each~     patient will be studied during a single treatment session of ten hours. The device will be~     connected to an existing, standard PD catheter that the patient will be using routinely~     prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted~     for the study). The patient will be hospitalized for observation during the test day and~     during the night following the study session. Ultrafiltration volume, dialysate glucose~     concentrations, blood glucose concentrations as well the patient's acceptability and~     tolerance of the wearable device will be evaluated.~   "
21778|NCT02772133|"~     Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation~     myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on~     circulating prolylcarboxypeptidase (PRCP) level and activity.~   "
21779|NCT02772120|"~     The aim of this study is to test the hypothesis that the pregnancy rates of women (ages~     18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41~     years of age) as part of their IVF treatment are not different with respect to the~     administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).~   "
21781|NCT02772094|"~     Purposes:~      The purpose of this phase-II clinical trial is to determine whether or not ADCTA-G, a~     biologic vaccine preparation of patient's own dendritic cell (DC) for glioblastoma~     multiforme (GBM) treatment, is safe and effective in extending the GBM patient's life. The~     current conventional multi-modal regimen that may include surgery for tumor resection or~     biopsy, temozolomide (TMZ) combined chemo-radiotherapy (CCRT) and TMZ adjuvant chemotherapy~     almost always leaves residual GBM cells to cause fatal recurrence, leading to medium~     survival period of 8 -15 months and over-all survival rates of about 30% in 2 years and <3%~     in 5 years after diagnosis/surgery. Thus, in neurosurgical oncology practice, GBM patients~     in the first 2-year period during and after receiving multi-modal therapy are watched~     closely for possible GBM tumor recurrence and mortal disease relapse and immediately given~     palliative treatments and health care, until death. In this phase-II trial, GBM patient~     participants who receive ADCTA-G vaccine adjuvant immunotherapy (added to the conventional~     multi-modal regimen) will be similarly watched closely by treatments and health care visits~     at least biweekly from the date of surgery/diagnosis to 24 months, and if alive followed by~     weekly phone calls and scheduled health care visits at least once every 3 months, up to 72~     months after surgery. In the trial protocol, ADCT-G in 10 doses is administered after~     surgery, over a period of 6 or 8 months, as an adjuvant immunotherapy of the conventional~     multimodal regimen. Individual ADCTA-G vaccine lot of every participant GBM patient is~     manufactured from patient's own monocyte-derived dendritic cells and the patient's own tumor~     cell antigens, both of which are prepared by a distinct method of procedures performed~     within air particle-free barrier good laboratory practice (GLP) facility. Previous phase~     I/II clinical trial of ADCTA-G vaccine immunotherapy administered as an adjuvant to the~     conventional multimodal regimen, has obtained promising safety and efficacy results for GBM~     patients in a clinical center. This phase-II clinical trial in China Medical University~     Hospital-Taichung will employ essentially the same clinical protocols and the same distinct~     vaccine manufacturing method of standard operational procedures (SOP), that is, the~     conventional multimodal regimen plus adjuvant immunotherapy using personal ADCTA-G vaccine~     lot for every GBM patient participants.~   "
21782|NCT02772081|"~     This study will compare the administration of porcine surfactant (poractant alfa, Curosurf®)~     through a less invasive method (LISA) using a thin catheter (CHF 6440) during non-invasive~     ventilation (NIV) (CPAP, NIPPV, BiPAP) with an approved conventional surfactant~     administration during invasive ventilation and rapid extubation in terms of short term and~     mid-term safety and efficacy in spontaneously breathing preterm neonates with clinical signs~     of respiratory distress syndrome (RDS).~   "
21783|NCT02772068|"~     Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart~     failure cases and is particularly common in the elderly. The disease has no current~     treatment options. Symptoms typically occur during exertion or exercise and is likely the~     result of increased cardiac and pulmonary congestion as a result of impaired diastolic~     function. Istaroxime is a novel activator of SERCA2a, an important regulator of calcium~     uptake within the myocyte. We will test the hypothesis that Istaroxime will improve~     diastolic function during exercise in HFpEF patients which in turn will reduce cardiac and~     pulmonary congestion.~   "
21784|NCT02772055|"~     This is a multicentre, randomised, single blinded, parallel-group design clinical trial to~     assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.~   "
21785|NCT02772042|"~     Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization~     and manipulation of upper cervical spine are the most popular treatment in this patients.~     The International Federation of Orthopaedic Manipulative Physical Therapists suggest~     different recommendations for the safety application of manual therapy techniques in the~     upper cervical spine, traction manipulation techniques complies with this conditions.~     However, there isn´t investigation about the effect of traction manipulation in patients~     with cervicogenic dizziness. The aim of this study is to investigate the effects of traction~     manipulation in dizziness intensity, range of motion of cervical spine and quality of life~     on patients with cervicogenic dizziness.~   "
21786|NCT02772029|"~     Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its~     incidence matches mortality, reflecting the poor prognosis of this disease. The surgical~     resection rate of HCC is low, and the prognosis is poor. Although transarterial~     chemoembolization (TACE) is the main treatment for HCC patients who are not candidates for~     surgical resection, it is not considered a curative procedure. For HCC, poor TACE efficacy~     or TACE failure may be related to tumor angiogenesis of the residual disease. Among the many~     regulatory factors in tumor angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular~     endothelial growth factor (VEGF) play vital roles in this process.~      Sorafenib is the first systemic treatment drug, which has been approved by the FDA for~     advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity,~     Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine~     kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor~     mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor~     growth inhibitory activity on glioma, this study aims to further verify the efficacy and~     safety of Apatinib for first-line treatment failure hepatocellular carcinoma patients, the~     primary endpoint is time to progression(TTP).~   "
21787|NCT02772016|"~     Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild~     anemia were randomly assigned to treatment group and control group. Patients in the~     treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while~     the control group were observed and followed up in the same period without any treatments.~     Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin~     components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)]~     were measured before and after treatments.~   "
21788|NCT02772003|"~     The purpose of this study is to determine whether INO-8000 alone or in combination with~     INO-9012 (IL-12) is safe and induces an HCV-specific immune response.~   "
21789|NCT02771990|"~     The goal of this study is to investigate the role of central neural pathways in mediating~     chronic pain. The aim of the study is to test the effect of stimulating brain regions that~     are part of a network underlying central pain processing using a non-invasive brain~     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have~     used tDCS to target both sensory related cortical areas and those important for higher-order~     representations of pain. This study will target brain regions important for the behavioral~     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain~     regions can modulate not only the affective component of pain, but ultimately also improve~     functioning and quality of life. This hypothesis will be tested by treating study~     participants eighteen and older with chronic low back pain (CLBP) of greater than six months~     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion~     criteria.~   "
21790|NCT02771977|"~     In this trial, patients with acute kidney injury who have recently received a drug that may~     affect kidney function will be randomized to having an alert placed in the electronic health~     record or usual care.~   "
21793|NCT02771938|"~     Many women with breast cancer now live for decades after their breast cancer treatment. In~     view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims~     to reproduce as natural a breast shape as possible. Keeping a natural breast appearance has~     been shown to be very important to a woman's emotional and psychological recovery.~      Breast cancer treatment often includes a combination of surgery, chemotherapy, radiotherapy,~     anticancer tablets such as Tamoxifen, and newer targeted drugs such as Herceptin.~     Radiotherapy is usually given after surgery. However, radiotherapy after mastectomy and~     breast reconstruction can damage the 'new' breast giving a less good breast shape and~     appearance in the longer term. Also, if recovery is slow following surgery, the radiotherapy~     is delayed which may reduce its effectiveness. Changing the order of treatments has been~     shown to be safe and effective for chemotherapy, Herceptin and anticancer tablets but we~     have very little information on giving radiotherapy before breast cancer surgery.~      The investigators want to find out if giving radiotherapy before mastectomy and~     reconstruction alters surgical complication rates and they want to evaluate the appearance~     of the reconstructed breast when radiotherapy is given before surgery.~   "
21794|NCT02771925|"~     Alcohol use disorders are present across medical specialties, with alcohol-related deaths~     particularly prevalent in the categories of injury, liver cirrhosis, cancer, cardiovascular~     disease, disorders of the peripheral nerves and of the central nervous system. Alcohol~     dependence, also referred to as alcohol use disorder, is a chronic, relapsing disorder~     marked by compulsive alcohol use, an inability to stop drinking despite harmful~     consequences, and the emergence of a withdrawal syndrome upon cessation of use. Early~     abstinence is associated with activation of brain stress systems in the extended amygdala.~     Clinically, protracted abstinence involves symptoms of craving, mood and sleep disturbance,~     all of which have been identified as risk factors for relapse. Nonetheless, implementation~     of alcohol-specific medications remains limited across most medical specialties. Medications~     for treating alcohol dependence primarily have been adjunctive interventions, and only three~     medications—disulfiram, naltrexone, and acamprosate—are approved for this indication by the~     United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission~     through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was~     originally approved by the Food and Drug Administration in 1977 for use in spasticity~     associated with neurologic conditions, such as multiple sclerosis and spinal cord lesions.~     However, due to its pharmacologic properties it has also been investigated for the treatment~     of alcohol dependence. But in the clinical practice of study physicians, it was observed~     that most of the patients who were prescribed baclofen for alcohol dependence hit back to~     alcohol very soon despite being on the drug. Therefore there is a need to search for an~     alternative drug which could be beneficial for this population of patients. Gabapentin is~     Food and Drug Administration-approved for the management of epileptic seizures and~     neuropathic pain. It is believed to act by blocking a specific alpha-2d subunit of the~     voltage-gated calcium channel at selective presynaptic sites and, as a result, to indirectly~     modulate Gamma Butyric Acid neurotransmission. Pre-clinical findings indicate that~     gabapentin normalizes the stress-induced Gamma Butyric Acid activation in the amygdala that~     is associated with alcohol dependence, and provide an excellent pre-clinical rationale for~     evaluating gabapentin as a treatment for alcohol dependence. Earlier studies of gabapentin~     in alcohol dependent subjects, attempting to abstain following withdrawal support the safety~     and potential efficacy of gabapentin in alcohol dependent patients, but definitive~     conclusions were limited by either small sample size, methodological, or dosing issues.~   "
21795|NCT02771912|"~     Controversies exist about the use of propofol in sedation of patients for cataract surgery.~     This prospective randomised double-blind study evaluates the efficacy of patient-controlled~     sedation compared with placebo using the same device.~   "
21796|NCT02771899|"~     Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to~     correct scoliosis will be included in this study, for which participation will last 6~     months. Each age group of participants will be randomized to two cohorts: one cohort will~     receive standard of care, while the other will also have their standard radiographic images~     used in the construction of a three-dimensional visualization of the spine. Questionnaires~     administered before and after surgery, in addition to health information collected~     throughout the course of the study, will indicate whether the three-dimensional model has an~     effect on the planning, performance, and outcomes of surgery. Participants in this study~     will not be asked to do anything outside the standard of care. The only manipulated variable~     in this study is the construction of the three dimensional model, which is made from~     information collected during the standard of care, and requires no further action on the~     participant's behalf. The results of this study may show that three-dimensional~     visualizations can be of value to spinal surgeons, and positively affect patient outcomes.~   "
21797|NCT02771886|"~     The purpose of this study is to evaluate the effectiveness of a brief Surf the Urge~     intervention to reduce adolescent and young adult (i.e., 14 to 24 years old) urge-related~     behaviors. These behaviors will include, but not be limited to, substance use, deliberate~     self-harm, aggressive behavior, pulling out hair, and loosing control when eating.The~     intervention will utilize mindfulness skills (i.e., awareness, acceptance, nonjudgment) to~     assist in reducing these risky behaviors.~   "
21798|NCT02771873|"~     The overall goal of the study is to test the effectiveness and sustainability of an~     integrated care model for managing cardiovascular risk in individuals with family history of~     premature coronary heart disease (CHD).~      This care model involves:~        1. screening for cardiovascular risk factors,~        2. providing lifestyle interventions for prevention and management of cardiovascular risk~          factors,~        3. providing a framework for linkage to appropriate primary health care facility and~        4. active follow-up of intervention adherence.~      Initially, a formative qualitative research component will gather information on~     understanding of diseases, barriers to care, specific components of the intervention package~     (for example, context specific ways to enhance physical activity and to reduce prolonged~     sitting time, ways to improve diet etc.) and feedback on the intervention strategies~     (lifestyle education, care and linkage coordination). Then a randomized controlled trial~     involving ~700 families and 1400 participants will be used to determine whether an~     integrated care model is effective in reducing or halting the progression of CHD risk~     factors and risk factor clustering in families. The sustainability and scalability of this~     intervention will be assessed through economic and qualitative lenses to estimate value and~     acceptability. Scalability will be informed by cost-effectiveness and acceptability of the~     integrated cardiovascular risk reduction approach.~   "
21799|NCT02771860|"~     This is a randomized, double blind placebo controlled one-site proof-of-concept study in~     subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.~      A total of 100 subjects will be enrolled into the study: 48 weeks placebo controlled~     double-blind phase with denosumab 60mg every 12 weeks, followed by a 48-week open-label~     phase in which all subjects will receive denosumab.~   "
21800|NCT02771847|"~     The pain associated with disorders of the masticatory system (DAM) include pain in the~     masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is~     the second musculoskeletal disorder most common behind chronic pain in the dos.~      Pain associated with DAM not interested adults; they were also observed in adolescents~     (2-6%) 7 with significant changes in their quality of life.8 The annual incidence of pain~     associated with DAM is 2.6% among adolescents and 3.9% for adults. 9 half to two-thirds of~     patients affected by DAM resorted to professional care, and one-third continued to be~     subjected to moderate pain and incapacity to severe, regardless of treatment given.~      Co-morbidities were identified in adults 12-14, children and adolescents with pain related~     to DAM, the United States and Suède. The most common painful co-morbidities among children~     and adolescents were headaches, neck, back, limbs or abdomen.~      The reasons for the co-existence of DAM with other painful conditions are not well~     understood. Nevertheless, it has been demonstrated in adults that they contributed to~     apparition and persistence DAM beyond healing time conventionally predicted; they increased~     deterioration state health and could complicate significantly the diagnosis and efficacy of~     treatment.~      Co-morbidity is defined as the simultaneous existence and the occur two or more diseases,~     medically diagnosed in the same person.~      The prevalence of several chronic painful conditions appears to be greater among people of~     low socioeconomic status compared with those of higher and higher socioeconomic status among~     women than hommes.~      head pain is commonly reported in the general population (46%) The headache prevalence~     ranges from 9% to 97% among adults and 30% to 94% among Adolescents with DAM.~      Women have a higher probability have pain related to DAM (odds ratio (OR) = 2.2, 95%~     confidence interval (CI): 2.1-2.4) or headache (OR = 2.5, 95% CI: 2.4-2.5) than men.~     Cross-sectional studies and case-control demonstrated that subjects with DAM-related pain~     were 1.5 to 8.8 times more likely to have headaches compared to those without pain~     associated with DAM.~      The relationship between headaches and DAM n`est unclear. Both conditions seem to share~     similar pathophysiological mechanisms that would promote the development of both diseases in~     a individual. Patients affected by headaches are more likely to develop a DAM? A cohort~     study showed that adolescents affected by headaches, the chance of developing pain related~     to DAM was 2.7 times (95% CI: 1.6-4.4) than adolescents without headaches. Conversely, the~     probability of having headache increases with the number of symptoms according to a~     relationship of DAM.~      Following the results of these studies cited before, it is now necessary to confirm the~     relationship between headaches and DAM among adolescents.~      Neck pain and back are symptoms commonly reported in adults with DAM (35% to 44%). 23 The~     adults affected by DAM have smaller mobility angles in the cervical and more sensitive~     points to trapezoids when compared to those without DAM.~      Cross-sectional studies and case-control have demonstrated that adult patients with~     DAM-related pain had 2.6 to 5 times more likely have back pain than individuals without pain~     related to DAM. Chances pain joint (OR = 4.0, 95% CI: 3.7-4.3) are larger among adults~     affected by DAM related pain compared to those indemnes. adults affected by DAM-related pain~     were also more likely to experience neck pain (OR = 4.0 to 7.9).~      Adult women affected by DAM-related pain are more likely to have pain in the neck (OR = 1.5;~     95% CI: 1.4-1.8) and back (OR = 1.2; 95% CI: 1.2-1.3) compared to hommes a prospective~     cohort study demonstrated that there was a greater likelihood of pain related to DAM among~     adolescents affected by back pain compared to those not affected (OR = 3.0, 95% CI: 2.2-6.8)~     Our study aims to seek more evidence on the supposed relationship between pain related to~     DAM and sore neck or back in the adolescent population.~      The irritable bowel syndrome (CIS; 9% to 16%), interstitial cystitis (17%), and stomach pain~     (34%) are rated among adults affected by DAM. Adults affected by DAM were 2.7 times (95% CI:~     1.4-5.1) more likely to have irritable bowel syndrome than subjects of the same age not~     affected. teenagers affected by DAM were 1.5 times (95% CI: 1.0- 2.1) over have luck stomach~     upset that the subjects of the same age unaffected.~   "
21801|NCT02771834|"~     The incidence of osteoporosis has been increasing, as have fractures resulting from falls.~   "
21802|NCT02771821|"~     Randomized clinical trial with the objective of evaluating the effectiveness of operative~     groups to promote healthy habits in elderlies diabetics. The study was conducted in the~     Family Health Units of Microregion 4.2 Sanitary District IV of Recife, Pernambuco, Northeast~     Brazil. Participated in 202 elderlies diabetic randomly assigned to two groups: intervention~     and control, with similar characteristics in relation to age. Data collection occurred from~     August 2014 to August 2015 and elderlies were followed for 6 months (T0 to T6). Control~     group participated in the routine individual consultation with the staff of the Family~     Health Unit on a quarterly basis. Intervention group participated the routine individual~     consultation with the staff of the Family Health Unit on a quarterly basi and six operative~     groups of health education, with monthly frequency and duration of two hours, using the~     methodology of problematization (FREIRE, 2011), with themes identified from the needs of the~     participants.~   "
21803|NCT02771808|"~     Specific aim 1a will test the hypothesis that diabetic patients with 2-2 haptoglobin~     genotype have higher indices of postoperative myocardial injury (creatine kinase MB~     isoenzyme , Troponin I ) and renal injury (as indicated by elevated creatinine, cytostatin C~     and glomerular filtration rate). Of note, significantly elevated levels (>5 times the upper~     normal limit) of creatine kinase MB isoenzyme and troponins postoperatively have been~     associated with postoperative myocardial ischemia/infarction and are a predictor of~     short-term and long-term mortality after cardiac surgery.~      Specific aim 1b will evaluate preoperative and postoperative indices of oxidative stress~     (such as isoprostane f2 alpha and malondialdehyde) and will evaluate whether patients with~     type 2-2 haptoglobin express increased oxidative stress. The investigators will also try to~     correlate whether patients with increased oxidative stress are those with elevated indices~     of myocardial and/or renal injury Specific aim 1c will try to evaluate whether patients with~     type 2-2 haptoglobin also have increased levels of inflammatory indices (C-reactive~     protein,[interleukin] IL-1, IL-2, IL-6, TNF[tumor necrosis factor]) and try to correlate the~     findings with postoperative myocardial and or renal injury.~      The incidence of atrial fibrillation after coronary artery bypass graft ranges from 19% to~     27%. The investigators will also look at any correlation of the type 2-2 haptoglobin and the~     incidence of post-operative atrial fibrillation.~   "
21804|NCT02771795|"~     A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or~     Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC~   "
21805|NCT02771782|"~     This study has three purposes:~      To investigate whether the immune response to pertussis is increased when TDaP-IPV is given~     together with BCG vaccine, compared to when it is given alone.~      To investigate whether BCG vaccination modulates the immune response to non vaccine target~     antigens (i.e., antigens/pathogens not used in the vaccine itself).~      To investigate whether TDaP-IPV vaccination modulates the immune response to non vaccine~     target antigens.~   "
21806|NCT02771769|"~     This is a multi-centre prospective study in which blood samples will be taken from 1500 male~     patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA~     extracted from these samples will be undertaken to determine whether copy number instability~     scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy~     results (i.e. Gleason score) in these patients.~   "
21807|NCT02771756|"~     The purpose of this study is to research more reasonable and safe methods of nutritional~     support to improve the nutritional status of tumor patients, which guarantees the anti-tumor~     treatment such as chemotherapy.~   "
21808|NCT02771743|"~     The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the~     treatment intensity of tandem high dose chemotherapy according to the treatment response to~     induction chemotherapy.~   "
21809|NCT02771730|"~     The purpose of this study is to test experimental human immunodeficiency virus (HIV)~     vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines~     stimulate an immune response. Researchers want to see how the immune system will respond to~     these vaccines as well as if they are safe to give to people. Participants cannot get HIV~     from these vaccines. However, researchers also want to see if the vaccine's adenovirus is~     contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and~     intimate contacts will be asked to participate as well.~   "
21810|NCT02771717|"~     The purpose of this study is to determine whether a low exhaled nitric oxide reading~     (<27ppb) is a good predictor of a negative response to inhaled steroid treatment for~     patients with symptoms suggestive of asthma.~   "
21811|NCT02771704|"~     Dental caries is an infectious disease mediated by a consortium of microbes in the oral~     cavity. The disease is characterized by demineralization of the tooth, if untreated, it~     leads to cavitation, discomfort, pain and eventual tooth loss. Frequently, complete caries~     removal of dentine carious lesions leads to exposure of the pulp affecting its vitality.~     Therefore, it is crucial that vitality of the teeth is preserved causing little damage to~     the pulp. Different approaches have been used to reduce or eliminate microorganisms~     underneath the restorations. Chlorhexidine has a strong antibacterial effect, particularly~     on planktonic bacteria. Its effect on bacterial biofilms is compromised, however The~     objective of this study is to examine the in vivo effect of diamine silver fluoride,~     potassium iodide and their mixture on bacteria present in deep carious lesions. Dentine~     samples from 5 carious lesions from each of 5 patients before and after treatment with test~     agents will be collected in pre-reduced sterile Ringer's solution and processed for~     microbiological evaluation. The samples after serial dilution and plating will be incubated~     in aerobic, anaerobic and CO2 atmosphere for 2-5 days. Colony forming units will be~     enumerated and the effect of antibacterial agents in question on the bacterial viability in~     carious lesions will be assessed.~   "
21812|NCT02771691|"~     This is a prospective parallel group design of group-based Mentalization-Based Therapy for~     Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A~     plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the~     effectiveness of our recruitment strategies; compliance with protocol/procedures; trends~     towards reduced self-harm.~   "
21813|NCT02771678|"~     The aim of this project is to estimate the quality of life for people with asthma and~     specifically the loss in quality of life associated with an asthma-related crisis event~     (accident and emergency (A&E) attendance or admission).~   "
21815|NCT02771652|"~     In this randomised controlled trial, the feasibility and effectiveness of an internet-based~     exercise intervention including progressive strength and endurance training (e-training) for~     PwMS was investigated. Primary outcome was health-related quality of life, secondary~     outcomes were muscle strength, aerobic capacity and lung function, physical activity and~     fatigue.~   "
21816|NCT02771639|"~     Introduction Periprosthetic joint infection (PJI) is a severe complication to hip~     arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant~     retention (DAIR) is recommended in early PJI in association with stable implants. Few~     studies have evaluated the outcome of DAIR in this fragile population.The purpose of this~     study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients~     treated with a hip arthroplasty.~      Methods A consecutive series of patients had been treated with either a total hip~     arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were~     retrospective analysed.~   "
21817|NCT02771626|"~     This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in~     patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.~   "
21818|NCT02771613|"~     After implementing a French version of a trigger tool validated for computerized detection~     of adverse events in patient's medical record, the study will be performed in three parallel~     randomized arms of three identical departments (each steaming from 6 types of medical,~     surgical or obstetrical departments with a total of 18 departments involved). This three~     arms will be: no intervention, education of department's staff by multi professional in situ~     simulation (adapted to the discovered adverse events), or simple but large diffusion of~     results and decisions of Morbidity Mortality Reviews.~      The interventions will be performed during a two-years period.~   "
21819|NCT02771600|"~     Needle-related procedures are the most important source of pain and anxiety in pediatric~     patients. Consequently, needle-phobia and anxiety are common in children with auto-immune~     disease and immune deficiency and may be barriers to adherence in treatment. The use of a~     non-pharmacological and easy-to-use approach, like the Buzzy® device, could be an~     alternative or adjuvant for the management of procedural pain and anxiety of these children~     during needle-related procedures.~      This study aims to determine the feasibility, acceptability and satisfaction of the Buzzy®~     device for procedural pain and anxiety relief of immunology-rheumatology patients undergoing~     needle-related procedures. The investigators will compare the Buzzy® device with an~     anaesthetic cream (Maxilene®) during needle-related procedures. The investigators also plan~     to assess feasibility outcomes and satisfaction of the nurses and the children with the use~     of the Buzzy® device. This pilot study should refine or modify the research methodology and~     improve the intervention being piloted before it's efficacy will be verified within a larger~     scale-study.~      The investigators strongly believe that the use of the Buzzy® device in immunology~     rheumatology department could optimise procedural pain and anxiety management. Since most of~     the treatments administered for auto-immune diseases and immune deficiency diseases are~     through subcutaneous or intramuscular injections, pain and anxiety management using~     non-pharmacological and/or pharmacological interventions should be prioritized. Given this~     knowledge, the investigators feel that this pilot study has the potential to contribute to~     pain and anxiety management of children undergoing needle-related procedures.~   "
21820|NCT02771587|"~     The main objective of the project is to assess whether there is an interaction between the~     effects of ethanol and energy drinks on driving performance.~      Secondary objectives include: to evaluate subjective effects (drunkenness) after~     administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine~     and taurine after alcohol and energy drinks administration and to assess if there is an~     increased risk of bleeding when both drinks are taken together.~   "
21821|NCT02771574|"~     This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous~     exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this~     subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach~     for this rare disease with unmet clinical need.~   "
21822|NCT02771561|"~     Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted~     breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes~     are usually associated with a drop in blood oxygen levels and brief awakenings, which~     disrupt the sleep of those affected and can lead to daytime sleepiness. OSA is associated~     with an increased risk of heart disease and stroke.~      In some individuals, the low oxygen levels in the blood can be made worse by also having a~     small hole in the heart, called a patent foramen ovale (PFO). This hole is present at birth~     in everyone, but in some people (about 30% of the normal population) it fails to close.~     Usually a PFO does not cause any medical problems. However, it may be recommended to have a~     PFO closed by key-hole surgery if someone suffers a stroke, severe migraine or if they are~     professional divers. There is a higher incidence of PFO in patients with OSA (25-50%)~     compared to the wider population and this may account for some of the observed increased~     risk of heart disease and stroke in patients with OSA.~      This study will assess the number of patients with OSA who also have a PFO, and whether~     closing the PFO can improve the symptoms of OSA (e.g. sleepiness, exercise capacity and~     general well-being), thereby enabling the patient to not be reliant on treatment for OSA. If~     the study shows that closing the PFO is beneficial then the investigators will assess in a~     larger study if this treatment can also reduce heart disease and strokes.~   "
21823|NCT02771548|"~     Background~      Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of~     the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in~     an attempt to increase joint stability and facilitate athletes to return to sport (RTS).~     Although ACLR is considered a relatively successful procedure, dynamic control risk factors~     and strength and power deficits in the involved limb are still present after patients return~     to sport.~      Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction~     cutting, have been shown to be common mechanisms of injury for the ACL in field sports .~     Returning to multidirectional sports requires a proficiency and efficiency of movement when~     carrying out these tasks. There is a lack of standardized, objective criteria to accurately~     assess an athlete's ability to safely RTS. Therefore, there is a need for research that~     simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular~     strength/power deficits that may explain poor outcomes following ACLR. This study aims to~     further investigate movement patterns, limb asymmetry and muscle strength deficit in~     patients post-surgery to identify risk factors for re-injury and criteria for RTS.~      The purpose of this study was to:~        1. Analyse kinematic (movement descriptors) and kinetic (forces that cause movement)~          during sports specific dynamic tasks at different time-points (6 and 9 months)~          following ACLR.~        2. To explore the association of those findings with those who re-injure, those who have~          persistent knee pain or with those who fail to return to sport.~        3. To compare the ACLR participants with age and gender matched healthy multidirectional~          athletes.~      It is hypothesised that biomechanical analysis will identify clear risk factors for poor~     outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific~     tasks will aid in the identification of athletes who are not yet ready to return to sport~     and will inform the clinician of what must be targeted in specific rehabilitation protocols~     before return to sport is considered.~      Brief protocol~      Participants will be recruited from patients who are scheduled to undergo anterior cruciate~     ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be~     recruited from local multidirectional teams. Participation will be voluntary and after~     obtaining informed consent patients will be asked to complete pre-operative questionnaires~     to ascertain injury information, and the function of their knee. During surgery the surgeon~     will fill out an intra-operative questionnaire. Items recorded will include graft type,~     laxity, involvement of other ligamentous structures, type of femoral and tibial fixation,~     meniscal or chondral pathology.~      Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while~     the healthy participants will be tested on one occasion. The 3D testing session will include~     capturing of jumping, landing, hopping and cutting mechanics through the use of three~     dimensional motion capture technology and force plates. Here reflective markers are placed~     on the skin at anatomical landmarks. These markers are picked up by the infrared cameras and~     tracked at 200 frames per second. Participants will make contact with a force plate with~     their foot on undertaking the movements. Force and marker data will be combined to calculate~     joint angles and moments. Participants will also perform a muscle strength test using~     equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be~     tested.~      Participants will also be asked to fill out validated questionnaires to monitor self~     reported knee function, their confidence in their knee and also collect data on any~     continuing adverse symptoms such as locking, giving way, swelling or pain. Participants will~     also be asked if and when they return to sport. Questionnaires will be administered to~     participants at pre-op, 3, 6, 9, 12 and 24 months post operatively.~   "
21824|NCT02771535|"~     Aim of the current study is to investigate the long-term efficacy of Metacognitive Training~     for Depression (D-MCT) and to explore whether previously observed effects at the 6-month~     follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained~     at the 3-year follow-up.~   "
21856|NCT02771093|"~     This is a multi-center, randomized, open-label, parallel-group comparative, exploratory~     study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or~     alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in~     patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).~   "
21857|NCT02771080|"~     This is a retrospective observational study to assess the relationship between peak systolic~     global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo~     images predicts post-operative low cardiac output syndrome defined as the need for an~     inotropic support during 24 hours or longer.~   "
21825|NCT02771522|"~     This is a prospective, single-centre clinical study to monitor caries lesion activity in~     orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify~     patients who have had dental appliances in place for a minimum of 12 months and have visible~     white spot lesions on the anterior surfaces of incisors and / or canines at de-bond.~     Following de-bond, images of the tooth surface will be taken with the Calcivis System.~     Presence or absence of elevated luminescence on the images will indicate activity /~     inactivity. Only patients with at least one tooth identified as active with the Calcivis~     System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images~     of the active teeth will be taken with the Calcivis System as before, at each follow-up~     visit.~      The percentage of teeth showing luminescence using the Calcivis System will be calculated~     and summarised for all subjects for each post-baseline visit, and additionally by~     Investigator and ICDAS score at Visit 1. For each subject the percentage of teeth with each~     ICDAS score will be calculated. This will then be summarised over all subjects for each~     post-baseline visit and the ICDAS score will also be cross-tabulated with the~     presence/absence of luminescence from individual teeth for each visit.~   "
21826|NCT02771509|"~     The objective of the study is to assess the safety and efficacy of BB3 in preventing AKI~     compared to placebo when administered to patients at risk for developing acute kidney injury~     (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).~   "
21827|NCT02771496|"~     The Cohort is a multi-site prospective data collection study that will enroll any patient~     with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be~     followed for up to the next 50 years of their lives to study courses of care, disease~     progression, treatment/surgical options/results, and specific sports-related outcomes in~     athletic patients. Subjects will complete quality of life surveys as part of the Cohort.~     Course of care will not be affected.~   "
21828|NCT02771483|"~     Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for~     the superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting~     which patients will develop large vessel complications remains a challenge. There are~     limitations with temporal artery biopsy, magnetic resonance angiography and ultrasound of~     temporal arteries and American College of Rheumatology classification criteria.~      Positron emission tomography (PET) has been shown to be a useful modality in detecting~     inflammation in large intra-thoracic vessels but previously has not been able to accurately~     detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer~     scanners can perform finer cuts of the head and can detect uptake in these arteries.~      This study has three main components:~        1. Cross sectional study assessing the accuracy of PET uptake in the superficial cranial~          and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA~        2. Cohort study assessing the prognostic implication of FDG aortic uptake on aortic~          diameter at 24 months~        3. Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without~          FDG PET uptake at 0, 6 and 24 months~   "
21829|NCT02771470|"~     Probiotics modulate the gut microflora and immune status in lung cancer who need~     chemotherapy.~   "
21830|NCT02771457|"~     The primary purpose of the project is to determine what is the best schedule for restarting~     infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis~     and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint~     would be the failure rate; the need to discontinue infliximab or change treatment. A~     secondary aim will be to determine if infliximab drug and antibody levels can predict~     clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and~     long-term steroid free remission rate, and serum and fecal inflammatory markers in response~     to infliximab.~   "
21831|NCT02771444|"~     This study aims to evaluate image quality of a low-dose tomosynthesis system versus a~     comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator~     and with the study device, and images will be assessed by several radiologists by comparing~     details in the images from the two systems.~   "
21832|NCT02771431|"~     Our study would be the first randomized study investigating the use of video conferencing~     via tablet computers versus traditional bedside rounding and its effect on clinical data~     such as length of stay and complications as well as patient satisfaction. As technology~     improves, medicine has an obligation to incorporate this technology to improve efficiency~     and cost-effectiveness. If telerounding is proven to not change outcomes or patient~     satisfaction, it saves time for the physician during office hours to see more patients or be~     productive in other ways. Telerounding could be applied in remote areas with a dearth of~     specialists, allowing these specialists' expertise to reach areas it could not before.~   "
21833|NCT02771418|"~     Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via~     the mechanism known as a preconditioning. A transient deterioration of local hemodynamics~     and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain~     and affect postoperative cognitive function. The goal of this study was to assess the~     effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.~   "
21834|NCT02771405|"~     The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients~     will undergo treatment with different regimens of DAAs.~   "
21844|NCT02771262|"~     Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO).~     It is the primary and most disabling symptom of chronic obstructive pulmonary disease~     (COPD). There is a high priority to improve dyspnea PRO assessment and predict~     exacerbations. Frequent exacerbations are associated with increased disability, decreased~     quality of life (QOL), and accelerated lung function decline.~      Goals: To test the relative sensitivity to change, responsiveness and predictive validity of~     a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and~     activity avoidance domains and is more efficient to administer than existing dyspnea scales.~      Expected Outcomes: Investigators expect to:~        1. begin to transform how dyspnea is assessed;~        2. improve dyspnea symptom management;~        3. impact functional status;~        4. improve QOL;~        5. facilitate the earlier treatment and prevention of exacerbations;~        6. improve COPD prognosis and survival; and~        7. improve COPD healthcare utilization.~   "
21858|NCT02771067|"~     The purpose of this study is to investigate the validity of pulse pressure variation to~     predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.~   "
21835|NCT02771392|"~     Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of~     eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US~     general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450~     work-related eye injuries and illnesses occurred that caused missed time from work.1Due to~     the large number of nerve endings even small corneal injuries can produce significant pain.~     The discomfort is typically most pronounced in the first 24-48 hours, and in many cases~     showed a loss in time at work and disruption of daily activities. The current standard of~     care in the emergency department includes topical analgesia and antibiotics with a change to~     oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating~     CA pain, most physicians do not prescribe topical analgesics based on standard medical~     teaching. The study's aim is to further investigate the role of tetracaine in the outpatient~     management of CA utilizing models already established to ensure safety. To accomplish this~     investigators will employ a prospective, double blind, randomized control model to compare~     undiluted 1% tetracaine hydrochloride to normal saline in patients presenting to the ED with~     uncomplicated corneal abrasions. Tetracaine will be supplied in three plastic prefilled,~     commercially available vials, each containing 0.5 mL of preservative-free, undiluted 1%~     tetracaine hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to~     avoid overuse). Saline will also be supplied in three plastic prefilled, commercially~     available vials, plastic bullets. Follow up visits or calls will be provide at 48 hour to~     reevaluate symptoms an asses the patients perceived pain using VAS provided in participant~     introduction packet during the informed consent process.~   "
21836|NCT02771379|"~     This study is a multicentre, prospective, non-interventional post-authorisation safety study~     (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.~      No medication will be provided as part of this study. Raxone® will be obtained through~     commercial channels.~   "
21837|NCT02771366|"~     Cerebral energy metabolism declines with advanced aging, and is implicated in age-related~     cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease~     (Parkinson's disease). In addition, age-associated increase in systemic and~     neuroinflammation is associated with a higher likelihood for development of Alzheimer's~     disease and neurodegenerative disease in older adults. Furthermore, decreased cerebral~     energy metabolism and increased neuroinflammation are both associated with deficits in~     cognitive function, even in the absence of neurodegenerative disease. In older adults,~     decreased cognition is strongly associated with the development of AD, increased rates of~     hospitalization, loss of functional independence, and increased mortality rate. Novel~     methods for preventing cognitive decline and neurodegenerative diseases in older adults are~     needed the world's aging population.~      Current research suggests that nutrients in fruits and vegetables produce strong~     anti-oxidant and anti-proliferative effects. Most Americans are not consuming the minimum~     recommendations of fruits and vegetables per day to receive these benefits. Whole food-based~     nutritional products, such as Fermented Papaya Product (FPP), may provide a healthy~     alternative for individuals. FPP, which is made by bio-fermentation of Carica papaya, has~     been found to enhance antioxidant protection and to decrease DNA damage in healthy older~     adults. Furthermore, if FPP increases cerebral energy metabolism and down-regulates~     neuroinflammation, with resulting effects on cognition, dietary supplementation with FPP may~     have preventative benefits for age-related cognitive conditions, including MCI, AD,~     Parkinson's disease and other neurodegenerative diseases.~   "
21838|NCT02771353|"~     This study aims to compare the resource impact, acute toxicity and feasibility of different~     pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in~     breath hold will be compared against volumetric modulated arc therapy (VMAT) in free~     breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments~     using voluntary deep inspiratory breath hold compared to an active breathing controlled~     breath hold device.~   "
21839|NCT02771340|"~     The purpose of this study is to evaluate the safety, tolerability, biological activity,~     pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal~     doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo~     enucleation or brachytherapy of the affected eye.~   "
21840|NCT02771327|"~     Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients~     undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange~     improve.~   "
21841|NCT02771314|"~     Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the liquid~     biopsy) may offer, we consider that it could be feasible to longitudinally monitor the~     genetic evolution and the biologic characteristics of CTCs, by using Circulating tumor DNA~     (ctDNA) and CTCs as a source of biologic material. This approach could provide information~     regarding the genetic/molecular changes associated with primary and acquired resistance to~     AZD9291 and, thus, to facilitate to more appropriately adapt the tailored treatment in this~     particular group of NSCLC patients. It has been recently reported that the detection of~     resistant clones, based on the tumor-associated genetic aberrations in the blood, can~     identify treatment resistance up to 10 months earlier than the radiological methods~     providing, thus, the potential for an early switch to a non cross-resistant therapy in order~     to improve patients' outcome.~   "
21842|NCT02771301|"~     This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma~     with IDH1R132H mutation.~   "
21843|NCT02771288|"~     To investigate the safety and long-term vascular remodeling after bioresorbable vascular~     scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with~     Kawasaki disease (KD).~      Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary~     artery lesion is the predominant determinant of KD outcome in the long-term. Children with~     KD with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of~     developing a clinically significant stenotic lesion during follow-up. They are at risk of~     myocardial infarction-related sudden death or congestive heart failure as young adults.~     Bypass surgery could be the reasonable strategy but the long-term patency of the graft~     remains unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation~     is the alternative. However, metallic stenting remains problematic in several aspects mainly~     due to the restriction of vessel expansive remodeling. The novel BVS has the potential to be~     free from the limitation due to scaffold degradation.~   "
21845|NCT02771249|"~     People with human immunodeficiency virus (HIV) often take several medicines to control HIV.~     Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take.~     They may also need to take medicines for an infection called latent tuberculosis (TB).~     Researchers think a once-weekly treatment for latent TB would be easier for people with HIV~     to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid.~     However, they need to see how TB drugs and HIV drugs interact.~      Objective:~      To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs~     together can be treated safely.~      Eligibility:~      Healthy adults ages 18 65.~      Design:~      Participants will be screened with a medical history and physical exam. They will have vital~     signs taken and give a blood sample. Women will have a pregnancy test.~      Participants cannot take any other medicines during the study, including vitamins. Only~     occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin~     or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as~     Benadryl , Zyrtec , Claritin , etc.) will be allowed.~      Participants will be assigned to one of three groups. Each group will take a different study~     drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a~     supply of the study drug tablets and instructions for taking them. Participants will keep a~     medicine diary to serve as a memory aid for taking medicine and reporting any side effects~     that they may experience.~      Participants will have 8 or 9 study visits over about 40 days. The number of visits depends~     on which group the person is assigned to. All visits will take place at the NIH Clinical~     Center. Participants will fast before study visits.~      The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last~     for about 12 hours. The other 4-5 visits will last about 1 hour.~      During all study visits, screening procedures will be repeated. During long visits, an~     intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to~     take blood.~   "
21846|NCT02771236|"~     Background:~      Genes are the basic units of heredity. When genes are changed, certain cells don t work like~     they should. Researchers want to try to better understand the genetic conditions that are~     linked with inherited eye diseases.~      Objective:~      To try to identify the genes linked to the development of inherited eye diseases.~      Eligibility:~      People ages 4 and older who have or have a family member with an inherited eye disease~      Design:~      Participants will be screened with medical history and medical records.~      Participants will have one visit that will take 3 4 hours. This will include:~      Medical and family history~      Eye exam: This includes the pupil being dilated.~      Electroretinography: A small electrode is taped to the forehead. Participants sit in the~      dark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put~     in~      the eyes. They will watch flashing lights.~      Blood tests~      Saliva sample: They will spit into a container or have the inside of their cheek swabbed.~      Genetic testing will be done on participants blood or saliva.~      Participants may meet with the researchers to discuss their genetic tests.~   "
21847|NCT02771223|"~     Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation~     abnormalities, most of which related to the direct, time dependent effect of the polymer~     tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the~     effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as~     well as on postoperative coagulopathy~   "
21848|NCT02771210|"~     The purpose of this study is to demonstrate efficacy, including effects on inflammation by~     magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis~     for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic~     Arthritis and axial Spondyloarthritis despite current or previous non-steroidal~     anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD)~     therapy.~   "
21849|NCT02771197|"~     AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem~     cell transplantation as a possible cure; however, many patients are not candidates for~     allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of~     available donors. Therefore, these patients are unable to receive the therapeutic benefits~     of the graft-versus-leukemia effect of donor immune cells. The aim of this study is to~     hopefully break immune tolerance to AML cells to provide better outcomes in patients with~     non-favorable risk AML.~   "
21850|NCT02771184|"~     This clinical trial is conducted within the research project 'Computerized Lung Sound~     Analysis'. The research goal is the development of a system enabling the automatic~     classification of lung sounds, which will result in a decision support system for~     physicians.~      The objective of this trial is to create a small lung sound corpus, enabling the development~     of a prototype of the described system. Therefore, investigators record lung sounds with~     several lung sound transducers distributed on the posterior chest of human test subjects.~   "
21851|NCT02771171|"~     CT and MRI based measurements of the pediatric airway has changed the age-old cone shape~     concept of the pediatric airway and define airway shape as elliptical structure. The cone~     shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by~     Eckenhoff in 1951.~      The present study is based on three-dimensional CT images of the airway column replicating~     the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was~     to determine the cone shape of the pediatric airway.~   "
21852|NCT02771158|"~     The purpose of this study is to determine whether midodrine administration decreases~     duration of intravenous vasopressors and intensive care unit length of stay for patients in~     septic shock.~   "
21853|NCT02771145|"~     The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft~     contact lens wearers of Japanese ethnicity. This study will be conducted in Japan.~   "
21854|NCT02771132|"~     The primary objective of this study is to compare the effectiveness of classroom-based~     behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of~     care intervention, on reducing the incidence of self-reported sexual assault among girls~     from baseline.~      Secondary objectives of this study is to determine the impact of the interventions on~     related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and~     self-esteem.~   "
21855|NCT02771106|"~     Mild TBI subjects will initially be identified by providers in the Hennepin County Medical~     Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the~     developmental optometrist to confirm if they do or do not have vision dysfunction related to~     the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of~     Minnesota (U of M), the whole brain will be imaged using resting state and task functional~     MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will~     then receive neurovision rehabilitation if they are in the vision dysfunction group. This~     treatment is standard care. Both groups will then undergo repeat objective vision testing by~     the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has~     resolved. Resting state and task fMRI and DTI will be done at the same time to compare~     functional and structural connectivity changes between the 2 groups.~   "
21859|NCT02771054|"~     Many HIV-infected individuals on effective antiretroviral therapy with suppressed HIV RNA~     levels in blood as well as in cerebrospinal fluid have signs of low-level intrathecal~     inflammation. Our aim is to study if changing the nucleoside backbone in an antiretroviral~     regimen can decrease the residual intrathecal immune activation.~   "
21860|NCT02771041|"~     Arthroplastic hip surgery fast-track the subject of increasing interest and reduces the~     average length of stay and improve patient satisfaction. This fast circuit implemented in~     many schools uses dedicated inpatient units, preoperative patient education in~     multidisciplinary groups (including physiotherapists, nurses, rehabilitation doctors and~     surgeons), an analgesia protocol multimodal and a network dedicated to the outlet (1.2).~      The investigators working hypothesis is that the mere realization of a preoperative visit a~     week before the intervention would reduce the average length of stay for all patients with a~     target of two nights (instead of 7.5 days currently) (3) to reduce the use of SSR during~     hospitalization. This consultation would serve to explain to the patient the early course of~     care, give advice and help to anticipate acts for its release post-operative as, for~     example, contact a physical therapist and a nurse or check to their community pharmacy if~     their heparin stock is enough and to answer any questions (Appendix 2: early information~     given to the patient consultation J-8).~      The investigators protocol is inspired by the one already in place for outpatient PTH and~     PTH 1 night but invariably apply to all patients for whom a home is considered output.~   "
21861|NCT02771028|"~     In this trial the investigators aim to establish whether Emotional Freedom Techniques (EFT)~     can reduce cognitive complaints in cancer survivors. All consenting patients aged 18 years~     or above, who have been diagnosed with a solid tumour of hematologic malignancy and who have~     completed or are in the late phase of a chemotherapy, radiotherapy, anti-hormonal or~     targeted therapy treatment, can participate in this trial. Patients should suffer from~     subjective cognitive complaints based on a score of 43 or more on the Cognitive Failure~     Questionnaire (CFQ). These patients will be randomly assigned to either the control or~     intervention group. Patients in the intervention group will be scheduled to receive an~     8-week EFT intervention program. Other patients will be placed on an 8-week wait list after~     which patients will also start the EFT program.~   "
21862|NCT02771015|"~     Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an~     expected hospital stay for 4 days or more will be included in the trial. Individual trial~     duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial,~     i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be~     assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).~   "
21863|NCT02771002|"~     The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral~     perfusion in patients in septic shock and after cardiac surgery.~   "
21864|NCT02770989|"~     This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for~     patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue~     near the PV.~   "
21865|NCT02770976|"~     This study is to investigate the effect of a wide range of assistance levels on respiratory~     pattern, breathing variability including tidal volume and peak inspiratory pressure during~     neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim~     to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal~     amplitude, work of breathing and comfort of preterm infants.~   "
21866|NCT02770963|"~     This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients~     with discogenic sciatica compared with sham acupuncture.~   "
21867|NCT02770950|"~     The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima~     plaster for patients in knee osteoarthrosis post-marketing.~   "
21868|NCT02770937|"~     This is prospective randomized controlled study to compare the proficiency of novices in~     acquiring laparoscopic suturing skills following either training in a virtual reality~     simulator or box trainer.~   "
21869|NCT02770924|"~     The aim of this study is to evaluate the visual function of patients with bilateral~     implantation of the IOL trifocal ZEISS AT LISA TRI TORIC by means of visual acuity tests~     with and without optical correction, sensitivity curve contrast, defocus curve and quality~     questionnaire visual function (VFQ-25).~   "
21870|NCT02770911|"~     The study evaluates the feasibility and advantage of modified laparoscopic double-staple~     anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior~     resection.~   "
21871|NCT02770898|"~     Evaluating the impact of probation on probationers is necessary for both effective practice~     of probation officers and their assessment of the success of their work. At present, there~     are limited studies that have evaluated the impact of probation services on probationers and~     their family. There are even fewer studies that have examined interventions on probationers'~     well-being and family relations in a Chinese society. Compared with the general population,~     probationers are associated with poorer mental (e.g., depression, lower levels of~     self-esteem, high level of stress) and physical health, and often experience higher levels~     of family conflict, and poorer quality of family relationships. Given the vulnerabilities,~     there is a need to strengthen and promote healthy lifestyle and enhance individual and~     family well-being among probationers. As part of the FAMILY project, the current study~     focuses on FAMILY Holistic Health which emphasizes a comprehensive approach to improving~     physical, mental, and social health and well-being. This project will be conducted as a~     pilot project in the Social Welfare Department (SWD) in the Eastern District of Hong Kong.~     Interventions will be delivered to promote and enhance probationer's wellbeing, as well as~     enhancing FAMILY 3Hs (Happiness, Health, and Harmony). Training programs will be provided to~     probation officers and/or workers of SWD in order to equip them with knowledge and skills in~     implementing health-related family intervention programs.~   "
21872|NCT02770885|"~     Glucagon like Peptide -1 (GLP-1) receptor agonists are well known to stimulate~     glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal~     and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1~     has been shown to reduce fluid intake after an oral salt load or during a meal - pointing to~     a hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic~     properties of GLP-1 might be of advantage in persons with an exaggerated thirst perception~     as is the case in patients with primary polydipsia.~   "
21873|NCT02770872|"~     Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major~     health issue in Veterans. Despite a number of different treatments, cardiovascular disease~     remains a major health burden, thus further treatments are needed. Individuals with obesity~     and/or diabetes are at particularly high risk for cardiovascular disease, and research~     suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular~     disease, particularly atherosclerosis. In preliminary studies in both mouse and human the~     investigators have identified that SAA appears to shift between lipid particles. SAA is~     mainly found on high density lipoprotein (HDL) particles; however, the investigators have~     found that in both mice and humans with obesity and/or diabetes SAA is found on low density~     lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators~     hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to~     cause cardiovascular disease. To determine what leads SAA to shift between lipid particles,~     SAA knockout mice will be injected with HDL containing SAA then blood collected at several~     time points over 24hours, and the lipid particles will be isolated to measure SAA. In some~     experiments the investigators will compare different isoforms of SAA, different types of HDL~     particles, or induce expression of enzymes likely involved in shifting SAA between~     particles. To determine if the presence of SAA makes lipid particles bind vascular matrix~     more strongly, the investigators will collect carotid arteries and compare the extent of~     lipid particles bound to the vascular matrix in the vessel wall when the particles have or~     do not have SAA present. If this research confirms this hypothesis then the presence of SAA~     on LDL or VLDL may 1) be a new marker indicating humans at highest risk for cardiovascular~     disease and 2) be a new target of therapy to prevent cardiovascular disease.~   "
21874|NCT02770859|"~     POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less~     (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical~     alternative to release the muscle & sphincter of the LES for the treatment of achalasia.~   "
21875|NCT02770846|"~     The purpose of this prospective randomized clinical study was to compare implant survival,~     patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate~     loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of~     follow-up.~   "
21876|NCT02770833|"~     The hypothesis is that seafood proteins given in combination with carbohydrates with low GI~     are superior to seafood proteins in combination with carbohydrates with high GI and meat in~     combination with both carbohydrates with low and high GI in promoting energy expenditure and~     satiety. The overall objective of this study is to investigate the acute effects of meals~     containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating~     hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.~   "
21877|NCT02770820|"~     This phase I/II trial studies the side effects of laboratory-treated (central memory/naive)~     cluster of differentiation 8+ T cells (autologous Wilms tumor [WT]1-T cell receptor [TCRc]4~     gene-transduced CD8-positive central memory T-cells [TCM]/naïve T cells [TN] lymphocytes)~     and how well it works in treating patients with acute myeloid leukemia that is newly~     diagnosed or has come back. Genetically modified therapies, such as autologous WT1-TCRc4~     gene-transduced CD8-positive TCM/TN lymphocytes, are taken from a patient's blood, modified~     in the laboratory so they specifically may kill cancer cells with a protein called WT1, and~     safely given back to the patient. The genetically modified T-cells have genes added in the~     laboratory to allow them to recognize leukemia cells that express WT1 and kill them.~   "
21878|NCT02770807|"~     This is an international, multi-center, one-year, randomized, prospective, double-blind,~     placebo-controlled, phase III study, designed to assess the effect of two non-overlapping~     dose ranges of EDS EP, administered by IV infusion once per month, on neurological symptoms~     of patients with Ataxia Telangiectasia.~   "
21879|NCT02770794|"~     This multicenter prospective clinical trial investigates the accuracy of ultrasound to~     predict relapse after discontinuation of infliximab and the efficacy/safety of~     readministration of infliximab in patients with rheumatoid arthritis in a low disease~     activity state.~   "
21880|NCT02770781|"~     The purpose is to examine the feasibility and preliminary effectiveness of the role of a~     personal trainer for non-metastatic breast cancer survivors to improve physical activity and~     well-being (in terms of quality of life).~   "
21881|NCT02770768|"~     The purpose of the present study is to understand the neurobiological mechanisms of action~     underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which~     desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating~     desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual~     desire as a manipulation check. The investigators will address this goal using a~     double-blind randomized outpatient design and determine the pre-post neurobehavioral change~     in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain~     activity in premenopausal women with HSDD and the extent to which regional brain activation~     is associated with changes in symptoms and behavior (as measured with self-report measures~     of sexual desire and/or eye-tracking movements).~   "
21882|NCT02770755|"~     This registry study will compile information about patients who are scheduled to receive or~     have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to~     treat muscle and ligament sports injuries.~   "
21883|NCT02770742|"~     This is a prospective, observational study to evaluate patient satisfaction with~     colonoscopy, depending on whether sedation is used during the procedure or not. Patients~     will receive questionnaires before the procedure to assess the potential influence of~     patient criteria and after the procedure to assess satisfaction-scores and pain-scores. A~     validated satisfaction score (Schoen et al.) will be used for the primary outcome. As~     secondary parameters, pain- and sedation-scores will be assessed by the validated NAPCOMS~     score, as well as procedural quality indicators. The study will assess, whether adequate~     selection in regards to risk factors for sedated or unsedated colonoscopy, leads to similar~     satisfaction-scores within both groups.~   "
21910|NCT02770391|"~     This is a research study to test an investigational drug (Not FDA approved), ARN-509 given~     in combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk~     prostate cancer who have already selected to have surgery to remove their prostate gland as~     part of their treatment plan. The main purpose of this study is to determine how tumors make~     androgens (male hormones), which makes these tumors more aggressive and resistant to~     hormonal therapy and how a short period of treatment with ARN-509 and leuprolide acetate~     prior to surgery can affect the production of these hormones in normal and malignant~     prostate tissue.~   "
21911|NCT02770378|"~     A proof-of-concept clinical trial assessing the safety of the coordinated undermining of~     survival paths by 9 repurposed drugs combined with metronomic temozolomide (CUSP9v3~     treatment protocol) for recurrent glioblastoma~   "
21912|NCT02770365|"~     To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug~     product in the treatment of vulvar and vaginal atrophy.~   "
21884|NCT02770729|"~     There has thus far been only one randomized and masked clinical trial in the world to~     evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the~     objective of preventing endophthalmitis following cataract surgery. The ESCRS study from~     2007 confirmed that the intracameral use of cefuroxime reduced the incidence of~     endophthalmitis approximately fivefold. Unlike in Europe, where this drug came to be widely~     used after the 2007 results, cefuroxime is not commercially available in Brazil. Many~     studies around the world have substituted cefuroxime with moxifloxacin, which is a drug that~     is easily found around the world in eye drop form. It is widely used in postoperative~     regimens in cases of ophthalmologic surgeries, and it is free of preservatives that are~     toxic to intraocular structures (corneal endothelial cells). Three studies (all respective)~     found that the intracameral use of moxifloxacin is safe and effective for preventing~     endophthalmitis following cataract surgery; however, no controlled, randomized, and masked~     clinical trials have been performed with this objective. If this trial confirms its~     hypothesis (a reduction in the incidence of endophthalmitis following cataract surgery) and~     if minimal side effects are reported, moxifloxacin may be an option for routine intracameral~     use during cataract surgery, thus reducing cases of endophthalmitis and consequent cases of~     blindness.~   "
21885|NCT02770716|"~     This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo~     in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.~   "
21886|NCT02770703|"~     Inguinal hernia repair can be considered as one of the most frequent surgeries in general~     surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally~     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some~     advantages and disadvantages. The posterior wall of the inguinal channel is usually~     reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.~      Two of the most frequent complications following hernia surgery are hernia recurrence and~     chronic groin pain. Latter can occur in up to 10%. Both represent a considerable~     socio-economic impact. While different surgical hernia procedures and mesh fixation~     techniques have been evaluated as influential factors, the impact of mesh position and mesh~     deformation on hernia recurrence and chronic groin pain is unknown. This may be even more~     important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the~     risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where~     the mesh position is not under direct visual control.~      Until now direct mesh visualization was impossible. A recent development of MRI visible~     meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and~     deformation after hernia surgery. In case of suspicious clinical hernia recurrence or~     postoperative chronic groin pain the mesh position can now directly be identified with~     Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.~      In this study the investigators plan to perform MRI scans to assess mesh position and~     deformation 90 days postoperatively and correlate it with the clinical status and pain score~     (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh~     position in relation to the operative technique, patients will be randomized to minimally~     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge~     this is the first study investigating the impact of the three most common surgical hernia~     procedures on postoperative mesh position and deformation and its correlation to the~     clinical findings focussing on hernia recurrence and chronic groin pain.~   "
21887|NCT02770690|"~     While propofol is widely used an anesthetic induction medication, it causes the mild to~     moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol~     injection pain.~   "
21888|NCT02770677|"~     COPD patients will be recruited and randomly assigned into one of each group: 1) Control~     group or 2) Yoga group. In Yoga groups, subjected will be asked to participate in Modified~     Dantien Yoga training for 12 weeks (3 times/week, 60 min/time). The subjects will be~     evaluated their pulmonary function, functional fitness performance, dyspnea score, and~     quality of life at baseline and after 12 wk training.~   "
21889|NCT02770664|"~     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126~     immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment~     Elevation Myocardial Infarction (STEMI).~   "
21890|NCT02770651|"~     The purpose of this study is to evaluate the incidence of late incomplete stent apposition~     (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting~     stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus~     zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa~     Rosa, CA, USA) implantation in patients with AMI at 12 months.~   "
21891|NCT02770638|"~     This study aims to establish clinical evidence for the use of scoop stretchers in the sports~     setting for spinal immobilisation and transport compared to the traditionally used long back~     boards through measuring tissue interface pressures over forty five minutes. All~     participants will be placed on both the scoop stretcher and the long back board for forty~     five minutes each, with at least 45 minutes between the two tests. A special mat that~     measures the pressure of the body against the board will be used to determine the pressure~     forces at certain points of the body touching the board (in mmHg). The participants will~     also be asked every five minutes during the experiment to rate the comfort of the device.~     Pressure measures from each participant on each board will be collated and assessed along~     with each participant's reported pain scores and comfort rating. The measurements from the~     tissue pressures will be analysed in real-time from the software connected to the~     pressure-mat and therefore show if pressures increase over time. A comparison between boards~     will be made.~   "
21892|NCT02770625|"~     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with~     Type 1 Gaucher disease.~   "
21893|NCT02770612|"~     The specific aim of this study is to use a shared decision making tool to allow women who~     have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants~     will be prescribed at discharge, within a range from 0-40 tablets. The study investigators~     will document additional information from medical record abstraction (age, race/ethnicity,~     medical and obstetrical conditions, previous opioid use, date of CD, indication for CD,~     anesthetic management during CD, duration and complications of CD, length of stay, pain~     medication use and pain scores on each postoperative day between CD and discharge). The~     investigators will then follow up with the participants by telephone at two weeks after~     discharge to assess the amount of opioid used, frequency of prescription refill, disposition~     of unused medication, and participant satisfaction with their post-cesarean pain control.~     The investigators hypothesize that the use of a shared decision making tool will decrease~     the amount of opioid prescribed while still providing participants with satisfactory pain~     control.~   "
21947|NCT02769910|"~     The purpose of this project is to investigate the effect of capsaicin-induced neurogenic~     inflammation with three different intensities on itch subsequently induced by histamine and~     cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation~     significantly increases susceptibility to itch provocations with cowhage and histamine.~   "
21894|NCT02770599|"~     Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn`s disease and~     Ulcerative colitis) both complex disorders requiring a long-term management, with~     significant healthcare resource consumption. Traditionally IBD patients has been treated by~     a variety of health care professional including doctors with specialist qualifications,~     assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has~     been a shift in the health care service from conventional follow - up (CF) to a rising~     numbers of health care models in term of Multidisciplinary team (MDT) also including care~     for IBD patients. MDT- models have been identified as important for continuity in patient~     centred care where nurses have a key role within the team by enhancing patient care.~     Patients have directly access to the IBD nurse who performing independently consultations at~     the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse~     is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of~     Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical~     quality survey with a single time point measurement, with consecutive recruitments of~     patients in the course of a 12-month period. Data will be collected from medical records and~     patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80~     recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will~     be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics~     committee and application to the Data protection Officer has been submitted. All~     participants are asked for provide written consent. The results can potentially contribute;~     to a better utilization of health care resources, improve quality of health and quality of~     care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by~     presenting a new challenging task concept, and identify the gaps in their own knowledge and~     skills. A well-established MDT can also be reasonable in a cost effective way by decreasing~     hospitalisation and fee up clinical spaces for the gastroenterologist.~   "
21895|NCT02770586|"~     The hypothesis of this study is that positron emission mammography will provide comparable~     sensitivity to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.~      The aim of this study is to determine the sensitivity of Positron Emission Mammography (PEM)~     relative to that of Contrast-enhanced breast MRI (CE-MRI) in women with a high suspicion of~     breast cancer~   "
21896|NCT02770573|"~     Aim: to investigate the clinical effectiveness over 12 weeks of three different~     biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity.~      Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite&White~     ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was~     generated by a cold stimulus directly to a sensitive tooth surface and assessed using the~     Visual Analogue Scale (VAS). The response was recorded before the application of the~     materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and~     12-week controls (POST-4).~   "
21897|NCT02770560|"~     Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading~     to inadequate dialysis dose, need to catheter replacement with as consequence progressive~     exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution~     to dissolve the clotting formed in of around the catheter lumen. There are few studies on~     the optimal approach of TCC-related thrombosis with thrombolytic containing locking solution~     (dose, number of administrations, timing of administration - intra or interdialytic use).~     The primary objective of this retrospective study was to compare the efficacy of inter~     versus intradialytic Urokinase containing locking solution on restoration of the TCC blood~     flow. The investigators also assess the question of multiple administrations of Urokinase~     are more efficient than one single administration~   "
21898|NCT02770547|"~     This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological~     intervention that could improve the mobility and exercise tolerance of patients with~     intermittent claudication. Thermotherapy is a simple, easily applicable therapy that~     enhances exercise tolerance in patients with chronic heart failure by improving peripheral~     vascular endothelial function.~   "
21899|NCT02770534|"~     Our primary aim in this study is to investigate the reported enhanced clotting state in~     adult patients with sickle cell disease using 2 laboratory tests; thromboelastography (TEG)~     and Endogenous Thrombin Potential (ETP), comparing the results to healthy race matched~     controls to see if there is a significant difference. Race matching of the control subjects~     is being carried out because of the well reported racial differences in coagulation~     parameters that exist in healthy individuals.~      We are aiming to study the clotting state in sickle patients on transfusion programs and~     hydroxycarbamide, both treatments offered to sickle patients to ameliorate the condition. We~     will assess the reported prothrombotic state using TEG and ETP.~   "
21900|NCT02770521|"~     The aims of this study are to evaluate:~        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as~          an injection just under the skin)~        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a~          single subcutaneous dose of a new LY900014 formulation in healthy Japanese~          participants.~      The study has two parts. Participants may only enroll in one part.~   "
21901|NCT02770508|"~     The purpose of this study is to compare the safety and efficacy of a combination of a QD~     regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir~     boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated~     tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve~     HIV-1-infected patients eligible to start ARV therapy according to current~     guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria~     and none of the exclusion criteria.~   "
21913|NCT02770352|"~     The objective of this proposal is to create a database for obstetric fistula patients at~     Bwaila Hospital containing their demographics, obstetric history, fistula history, physical~     exam findings, intraoperative and postoperative results. Data collection will be prospective~     starting in 2011 upon institutional review board (IRB) approval to last a minimum of five~     years and will have a retrospective component tracing back to January 2010. Primary goals of~     data analysis will be to determine the risk factors for fistula formation, risk factors for~     poor surgical outcomes and long-term incontinence, social and economic impact of fistula~     repair, and the ability of various physical exam findings to predict likelihood of~     successful repair. It is expected that findings will lead to improved surgical management of~     obstetric fistulas both locally and internationally.~   "
21945|NCT02769936|"~     Impairments in plasticity and working memory in schizophrenia have been hypothesized to~     reflect dysfunction at the N-methyl-D-aspartate glutamate receptor (NMDAR). However, the~     specific mechanisms through which the NMDAR is involved in working memory versus plasticity~     differ. Towards gaining a deeper understanding of how NMDAR signaling relates to individual~     cognitive functions in healthy adults and patients with schizophrenia, the investigators~     used a single dose of d-cycloserine (DCS) as an experimental probe to examine the effects of~     enhancing NMDAR signaling on plasticity versus working memory in healthy adults and~     individuals with schizophrenia.~   "
21902|NCT02770495|"~     It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease~     (CD) result from an aberrant T-cell mediated immune responses characterized by a complex~     balance between peripheral and lamina propria regulatory and effector T cell subsets.~     Because most of CD patients who undergo a surgery experienced a postoperative endoscopic~     recurrence of the disease (70 % at one year) leading to a clinical recurrence (10 % per~     year), the model of postoperative recurrence in CD represents a privileged situation that~     mimicks what happens in the gut of CD patients in clinical remission before the occurrence~     of further flares. It is likely that the same factors which underlie the immunopathogenesis~     of CD at its early stages also contribute to disease recurrence in the postoperative~     setting. Indeed, the postoperative state is performed for intent of disease remission and~     this situation represents probably an ideal setting to investigate the dynamics of most of T~     cell subsets in the peripheral and mucosal compartments because one may argue that removal~     of the diseased segment of bowel resets the disease to its earliest phases, providing an~     interesting window to better understand which T cell subsets predispose to disease~     recurrence.~      That is the reason why this model will be used in the present project i) to understand~     better the immunopathogenesis of CD relapse; ii) to identify novel and promising immune~     cell-associated biomarkers capable to predict relapse of the disease and finally iii) to~     identify potential specific therapeutic target associated with T cell subsets involved in~     the initiation of disease.~   "
21903|NCT02770482|"~     The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal~     fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has~     justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant~     results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this~     challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40~     (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate~     the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the~     total amyloid burden. Literature data on this topic are sparse and to date, no report has~     been published evaluating the utility of this marker in the diagnostic strategy for AD.~   "
21904|NCT02770469|"~     The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education~     and Relationships) program was to examine the effectiveness of one of the first~     linguistically and culturally tailored intervention programs to increase quality of life~     among Korean American breast cancer survivors.~   "
21905|NCT02770456|"~     This randomized controlled trial with fish oil supplementation to pregnant women conducted~     in areas of China, which are generally low in fish intake and low income, aims at answering~     the following primary questions:~        -  Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth~        -  Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth~        -  Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of~          spontaneous delivery in the preterm period~   "
21906|NCT02770443|"~     Randomized study of medication withdrawal in patients who have recovered LV function in~     Dilated Cardiomyopathy.~   "
21907|NCT02770430|"~     Steroids are still the first line treatment for established severe~     acute-graft-versus-host-disease (aGVHD), with a response rate of 30-50%, and there is no~     established and effective therapy for severe steroid-refractory (aGVHD). The outcome for~     patients is poor and overall survival low, with few patients alive at 2 years.~      In the case of failure after corticosteroid treatment, different therapeutic options have~     been introduced as second or third-line strategies. In this scenario, infusion of ex vivo~     expanded mesenchymal stromal cells (MSCs) has emerged as an additional tool for treatment of~     GVHD.~      The purpose of this work is conduct a study in patients with refractory and/or resistant~     GVHD corticosteroids treatment. It will be randomized into two groups: one group that will~     receive the MSCs and the other group will follow the acute GVHD steroid-resistant and/or~     refractory treatment according to the routines of the Bone Marrow Transplantation (BMT)~     service of Hospital de Clinicas de Porto Alegre. It will be evaluated aspects of immune~     recovery early after MSCs infusion.~   "
21908|NCT02770417|"~     Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD)~     suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a~     combination of physical inactivity and muscle oxidative stress. Pilot data (not published)~     clearly show that patients with COPD have significantly lower carnosine, which is a pH~     (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared~     to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in~     trained and untrained healthy subjects. This study will assess if muscle carnosine can be~     augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive~     beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be~     assessed to compare baseline muscle carnosine levels.~      The aims of this study are to:~        1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger~          sample of patients with COPD compared with healthy elderly subjects~        2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients~          and whether it has an influence on exercise capacity, lower-limb muscle function and~          quality of life~        3. To investigate baseline and post supplementation structural and metabolic muscle~          characteristics and markers of oxidative stress and inflammation in COPD patients and~          it's association with muscle carnosine levels~   "
21909|NCT02770404|"~     This is a Phase 1, randomized, double-blind, single-center, placebo-controlled,~     sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in~     Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or~     placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to~     receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each~     crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100,~     200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.~   "
21928|NCT02770157|"~     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short~     children born small for gestational age.~   "
21929|NCT02770144|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health.The investigators will evaluate the MFP's~     impact on child overall health rating.~   "
21914|NCT02770339|"~     The purpose of this study is to determine the proportion of children presenting to a~     pediatric emergency department with an acute mental health/behavioral crisis or clinical~     drug toxicity who have a match or mismatch between the genes for drug metabolizing~     enzymes and their current or recent drug therapy. The investigators will utilize a readily~     available and FDA-approved cheek swab DNA test --GeneSight®--in these children that~     categorizes patients into 3 different type of groups - RED, YELLOW, and GREEN based on~     individuals' abilities to metabolize psychotropic drugs . Specific objectives include:~        -  The relationship of genomic mismatch to serum drug concentrations, either low or high~        -  The proportion of children with a genomic mismatch who present to PED with intentional~          self-injury.~        -  The relationship between match versus mismatch and self- and caregiver-reported~          outcomes of functioning, drug efficacy, and drug tolerability.~        -  Examine the proportion of children/adolescents who present to PED with an adverse drug~          reaction to one or more psychotropic with a genomic mismatch.~        -  Quantify the specific adverse reactions related to a mismatch of genotypes.~   "
21915|NCT02770326|"~     The purpose of this study is to test the safety of FMT in patients with C. difficile and~     cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics~     have failed, but most of these studies have not included patients with cancer. The~     investigators want to prove that FMT is safe in this group of people so that doctors will~     feel more comfortable prescribing it for their patients with cancer.~   "
21916|NCT02770313|"~     The goal of this study is to determine how effective repeated fasting over 26 weeks (6~     months) is at improving risk parameters that are surrogate endpoints for cardiovascular~     diseases, metabolic dysregulation and cognitive impairments.~      Subjects will be randomized 1:1 to water-only fasting or to their ad libitum usual diet,~     with randomization performed within strata based on fasting history (≤180 hours or 181-720~     hours of total fasting for >12 consecutive hours per episode in the previous two years).~     Subjects will be assessed at 4, 13 and 26 weeks following randomization.~   "
21917|NCT02770300|"~     The primary goal of this project is to test the safeness and clinical effectiveness of a~     novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS)~     developed at Wearable Robotics srl, for the force assistance of stroke patients during~     robotic-rehabilitation.~      The secondary study aim is to design and test an automatic personalized robot-based upper~     limb motor rehabilitation protocol targeting the specific kinematic performance of each~     patient.~      Finally, the study also aims to define the neuro-biomechanical state of the patient and~     its evolution during the therapy by studying cortical signals and muscular synergies. This~     information will be used to improve the personalization of the robotic treatment by~     targeting not only the motor performance but also the cerebral and muscular activity of the~     patient.~      The study is longitudinally designed in order to test the safeness and clinical~     effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the~     automatic personalized robotic therapy from the beginning until the end of the treatment.~     Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the~     assessment methods proposed in the clinical trial will be repeated one month after the end~     of the treatment.~   "
21918|NCT02770287|"~     The study will confirm that the Freeze Diamond polar applicator is safe for treating the~     Mons pubis and Labia, and will result in improvement in general skin appearance including an~     improvement in skin irregularities and skin laxity.~   "
21919|NCT02770274|"~     To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg~     twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in~     patients undergoing peripheral angioplasty or stenting or both for the management of~     peripheral arterial disease.~   "
21920|NCT02770261|"~     The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy~     in patient with hypertension and primary hypercholesterolemia.~   "
21921|NCT02770248|"~     The purpose of this study is to evaluate differences between treatments in mean change from~     baseline in 24-hr IOP at Week 4.~   "
21922|NCT02770235|"~     In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An~     association was shown between AGE measured by biopsy (invasive) and DE patients with~     diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored~     the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence~     (AF) Skin (AGEReaderTM).~      If the hypothesis of an association between DE and AGE measured by AF was checked, screening~     for erectile dysfunction and measurement of AGEs could help to improve the overall~     management of diabetic patient (including cardiovascular) and their quality of life.~   "
21923|NCT02770222|"~     The primary objectives of this 2-part drug interaction study are as follows:~        -  To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the~          blood) of selexipag and its metabolite ACT-333679 (Part I).~        -  To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its~          metabolite ACT-333679 (Part II).~   "
21924|NCT02770209|"~     This study is aimed at evaluating the feasibility and effectiveness of a completely natural~     tissue engineered cartilage, composed of a self-made tissue engineered oriented scaffold and~     autologous chondrocytes, for repairing articular cartilage damage following injury. And it~     is also aimed at investigating the safety of tissue engineered cartilage transplantation.~   "
21925|NCT02770196|"~     The purpose of this study is to better understand how participation in cost-subsidized~     community supported agriculture programs paired with tailored education can affect diet~     quality and energy balance among children in low-income families.~   "
21926|NCT02770183|"~     The rational of the study is the description of the evolution of systolic cardiac function~     post-stunning, evaluated by transesophageal minimally invasive echocardiography (hTEE). The~     uses of these non-invasive methods have proved to be accurate for the qualitative and~     semi-quantitative determination of the contractile function of the left ventricle and the~     volume status of the patient. Furthermore the use of this technique has been demonstrated to~     be a reliable method to analyze the stunning recovery infarction after controlled cardiac~     arrest during the extra-corporeal circulation.~   "
21927|NCT02770170|"~     The overall purpose of the study is to assess the efficacy of three different doses of BI~     655064 against placebo as add-on therapy to standard of care (SOC) treatment for active~     lupus nephritis in order to characterize the dose-response relationship within the~     therapeutic range, and select the target dose for phase III development.~   "
21931|NCT02770118|"~     The goal of this proposed research is to test the hypothesis that long-term mild sleep~     restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy~     balance and weight gain.~      Aim 1. To determine the effects of SR, relative to habitual sleep (HS), on food choice and~     energy intake (EI) in adults at risk of obesity.~        -  Hypothesis 1a. EI, assessed by multiple weekly 24-hour recalls, will be greater during~          a period of SR relative to HS. This will be mostly due to increased fat and~          carbohydrate intakes.~        -  Hypothesis 1b. Neuronal responses to food stimuli, assessed by functional MRI (fMRI)~          after 6 weeks of SR or HS, will indicate increased activity in networks associated with~          reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative~          to HS. These responses will be correlated with intakes of high carbohydrate and high~          fat foods (hypothesis 1a) and neuropeptide Y (NPY). Moreover, activation of the default~          mode network (DMN) will be suppressed to a lesser extent after SR compared to HS.~      Aim 2. To determine the effects of SR, relative to HS, on energy expenditure (EE) via~     independent and complementary approaches.~        -  Hypothesis 2a. EE, assessed by doubly-labeled water (DLW), and physical activity level,~          monitored daily by actigraphy, will be lower during SR relative to HS.~        -  Hypothesis 2b. Brown adipose tissue (BAT), assessed by positron emission tomography and~          magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET)~          and fat fraction (FF) measurement under cold stimulation, will be greater after SR~          relative to HS. This would suggest higher adaptive thermogenesis after SR compared to~          HS. BAT activation will also be correlated with NPY.~      Aim 3. To determine whether SR alters body weight and adiposity relative to HS.~        -  Hypothesis 3a. SR will lead to weight gain and increased total adiposity, as assessed~          using magnetic resonance imaging (MRI), relative to HS.~        -  Hypothesis 3b. Increased adiposity after SR will be correlated to an adverse~          cardio-metabolic risk profile (increased glucose, insulin, triglycerides, leptin,~          reduced high-density lipoprotein cholesterol and adiponectin) and neuronal responses to~          food stimuli (Hypothesis 1b), and EE (Hypothesis 2a & 2b). Failure to stimulate BAT~          with SR will be associated with greater gain in adiposity.~   "
21932|NCT02770105|"~     L-theanine and caffeine are nutritional compounds that are naturally found in tea. Our~     recent findings using an EEG paradigm are consistent with the findings of others, indicating~     that intake of L-theanine and caffeine reduce the time needed for a person to differentiate~     between two visual stimuli and react to only one stimulus. In order to understand how these~     compounds give rise to these improvements, the investigators need to study how these~     compounds are related to various areas of the brain. To achieve this, the investigators plan~     to scan the brains of nine participants after they take either 1) L-theanine alone, 2)~     caffeine alone 3) the combination of both L-theanine and caffeine as compared with a placebo~     (distilled water), to see which has the greatest impact on attention and on regions in the~     brain that bring about attention.~   "
21933|NCT02770092|"~     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic~     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,~     treatment response and survival. Loss of muscle protein is generally a central component of~     weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone~     density, independent of the severity of the disease state. The purpose of this study is to~     provide detailed insight in disease related gut function by obtaining information on gut~     permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients~     compared to matched healthy controls. This will provide required information that is~     necessary to implement new strategies to develop optimal nutritional regimen in CHF and~     COPD.~   "
21934|NCT02770079|"~     Aim of the study:~      To define insulin requirement during pregnancy and to identify the rapid changes in insulin~     sensitivity around parturition and the first 6 months post partum. Such knowledge would be~     clinically useful and markedly improve insulin treatment before and after parturition for~     women with type 1 diabetes and serve to identify the best possible timing of testing women~     with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.~      Method:~      Botnia clamp in women before, immediately after delivery and 6 months post partum. The~     investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6~     months post partum with 20 normal women investigated at the same time points. In addition~     the investigators will collect feces samples from the mother and baby in order to determine~     microbiota.~      Perspectives:~      Diabetes is a common condition with important implications for pregnancy outcome and~     long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is~     expected to have beneficial consequences both for the pregnant women and the future~     generation.~   "
21935|NCT02770066|"~     A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA)~     in high-risk patients with renal artery stenosis selected on the basis of common national~     criteria, and with a common follow-up protocol for all three Danish centres offering PTRA~   "
21936|NCT02770053|"~     The purpose of this study is to determine whether enlarging the apical foramen causes~     postoperative pain in teeth with necrotic pulp and apical periodontitis.~   "
21937|NCT02770040|"~     The purpose of this study is to identify whether an Accelerated or Intensified Infliximab~     induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an~     open label multi-centre randomised controlled trial.~   "
21938|NCT02770027|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing colon surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and~     Group-HES (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number).~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will~     be determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
21939|NCT02770014|"~     Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation)~     in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study.~      This research study is evaluating a new blood test that is capable of detecting an EGFR~     mutation in cancer without a biopsy.~   "
21946|NCT02769923|"~     The investigators will assess the usability and immune response following fractional dose~     inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters~     (ID adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star~     Syringe Ltd.) and compare the response with the one achieved with fIPV administered with~     traditional BCG needle syringe.~   "
21940|NCT02770001|"~     Background: In genetic studies, the quality of DNA samples is tested first. Samples that are~     low-quality are not used. Some studies involve minority ethnic groups. And example is~     admixed African American. These studies often have small sample sizes. It is important to~     make sure samples are not discarded unnecessarily. This may happen by using quality control~     (QC) thresholds for homogenous groups. These may not be appropriate for an admixed group.~     Researchers want to study samples that failed certain QC tests. They want to see if this has~     to do with the ancestry of the outliers or the quality of the samples.~      Objectives:~      To study samples that fail heterozygosity and sample genotype call rate QC. To see if the~     failing rates have to do with the ancestry composition of the outliers or the quality of the~     samples.~      Eligibility:~      No new participants. Researchers will review data that has already been collected.~      Design:~      Researchers will study DNA samples in a lab.~      The samples will not include data that can identify the person the sample came from.~   "
21941|NCT02769988|"~     Background:~      The Teen Health Information Literacy Project is an after-school program for high school~     students. It gives them skills to access valid and reliable health data. It also aims to~     grow young health advocates. Researchers want to find out more about the impact the program~     has had on students. They want to use this feedback to improve the program.~      Objective:~      To gain feedback about the Teen Health Information Literacy Project.~      Eligibility:~      Young people who participated in the Teen Health Information Literacy Project. The project~     was run by Area Health Education Centers (AHECs) and sponsored by the National Library of~     Medicine (NLM).~      Design:~      The study will be explained to students during a program session. They will take consent~     forms home to their parents.~      Participants will split into 6 focus groups. Each one will be conducted at an AHEC project~     site.~      The focus group will be a 90-minute discussion between participants and an evaluator from~     the NLM. The evaluator will be present either in person or by video conference.~      The evaluator will ask participants questions, which may include the following. What did~     they like and dislike about the program? Why did they decide to participate? What have they~     learned? Would they recommend this program to another student? How has the program affected~     their interest in health-related careers?~      The discussion will be audio-recorded. The evaluator will use an automated tool to convert~     recordings into text. After that, she will destroy the audio.~   "
21942|NCT02769975|"~     Background:~      Endocrine glands give off hormones. Researchers want to learn more about the disorders that~     affect these glands in children. These disorders might be caused by changes in genes. Genes~     contain DNA, which is the blueprint of how a cell works. Researchers want to identify the~     genes involved in endocrine and metabolic disorders. This might help develop new ways to~     diagnose and treat the disorders.~      Objective:~      To study the inheritance of endocrine or metabolism disorders.~      Eligibility:~      Children ages 0 18 with known or suspected endocrine or metabolism disorders.~      Family members ages 0 100. They may participate in the DNA part of the study.~      Design:~      Participants will be screened with a review of their medical records. Their parents or~     guardians will allow the records to be released.~      Participants will have a clinic visit. This may include a physical exam and medical history.~      Parents or guardians will give their consent for the study. Participants may have tests,~     surgery, or other procedures to help diagnose or treat their condition. These could include:~      Blood, urine, and saliva tests~      Growth hormone test~      Pituitary and adrenal function tests~      Picture of chromosomes~      Imaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.~      Genetic tests~      Sleep study~      Medical photographs~      If surgery is done, a tissue sample will be taken.~      Participants may have follow-up visits for diagnosis and treatment.~      Participating relatives will have one visit. This will include medical history and blood and~     saliva tests. The blood and saliva will be used for DNA testing.~   "
21943|NCT02769962|"~     Background: CRLX101 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug~     called camptothecin. The combined molecule or nanoparticle drug conjugate travels through~     the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule.~     Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by~     chemotherapy. Researchers want to see how safe it is to give CRLX101 and olaparib together~     and to see how well the combination treats a specific type of lung cancer called small cell~     lung cancer (SCLC).~      Objectives:~      To test the safety and maximum dose of CLRX101 and olaparib together. To test how well they~     treat small cell lung cancer.~      Eligibility:~      Adults 18 and older with small cell lung cancer.~      Design:~      Participants will be screened with standard cancer care tests.~      Participants will get the 2 study drugs in 28-day cycles. CRLX101 will be given every 2~     weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a~     day most days. Participants will keep a pill diary.~      For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.~      At study visits, participants may have:~      Blood and hair samples taken~      History and Physical exam~      Questions about health and side effects~      Pregnancy test~      Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. .~      CT scan~      Injection of CRLX101 (twice per cycle)~      <TAB>Olaparib prescription <TAB>~      Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will~     have a physical exam and blood tests. They may have a tumor biopsy. The study team will call~     the patient every 3 months for follow up after completing the study treatment.~   "
21944|NCT02769949|"~     Background: Some patients with unusual genetic conditions are referred to the National~     Institutes of Health (NIH). They may not be eligible to join current research studies.~     Testing such patients is a good way to improve the skills of research staff. The findings~     could lead to new processes and research.~      Objectives:~      To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic~     staff hands-on experience working with these patients.~      Eligibility:~      Children any age with a known or suspected genetic disorder.~      Design:~      Participants will be screened with medical history and physical exam. They may have lab and~     other tests.~      Family members may give DNA samples.~      Participants will have:~      Medical history~      Physical exam~      Height, weight, and other measurements taken.~      A clinical evaluation of their disorder.~      They may have:~      Blood, urine, and saliva samples taken~      Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey.~      A sleep study~      A visit with other specialists at NIH~      A genetic test from a commercial lab~      Medical photographs taken~      Other tests~      Participants may have follow-up visits. They may get medical or surgical treatment.~   "
21948|NCT02769897|"~     The study aims to evaluate the possible effects of an exercise program, nutritional and~     psychological, postural orientation and guidance of oral health on body composition,~     physical activity levels and lifestyle, physical fitness and health and motor performance,~     the factors risk of cardiovascular disease, eating habits, the cognition levels, the~     psychological profile, the body posture of children and adolescents with overweight and~     obesity, considering the presence of risk genotype associated with the development of~     obesity. In addition, identify the effects of orientation for oral health on the quality of~     life and healthy oral habits.~   "
21949|NCT02769884|"~     This study trials a prototype artificial pancreas system that consists of a Roche insulin~     pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model~     probabilistic predictive control) algorithm housed on an android cell phone. The system~     doses insulin based on CGM sensor glucose levels and the experimental algorithm.~      The aim of this clinical study is to determine the efficacy of the MMPPC controller in~     adolescents and adults with type 1 diabetes in a hotel setting.~   "
21950|NCT02769871|"~     The investigators aim to examine the effect on smoking cessation rate by showing stroke~     patients who are active smokers images of their strokes.~   "
21951|NCT02769858|"~     The proposed study aims to establish the feasibility of light therapy for postpartum~     depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate~     relationships between circadian shifts and mood changes using a novel, home-based circadian~     biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).~   "
21952|NCT02769845|"~     Prospective screening and treatment study for children with Sickle Cell Anemia and increased~     stroke risk living in the Dominican Republic.~   "
21953|NCT02769832|"~     The purpose of this research study is to see if Abraxane and Gemcitabine given together will~     be effective in treating small cell lung cancer that has progressed after one line of~     treatment.~   "
21954|NCT02769819|"~     This study is designed to identify patients' features predictive of difficult endotracheal~     intubation using a flexible fiberscope.~   "
21955|NCT02769806|"~     The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM~     patients undergoing post-operative MRI for monitoring of tumor progression.~   "
21956|NCT02769793|"~     The purpose of this study is to determine whether levodopa/benserazide dispersible is~     effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.~   "
21957|NCT02769780|"~     Nexus is a collaboration between academic institutions, advocacy and industry to answer~     important questions about narcolepsy. It is a web-based observational study of~     patient-reported outcomes in adult patients with narcolepsy, with follow-up every six~     months.~      Nexus website: www.narcolepsyregistry.com~   "
21958|NCT02769767|"~     HLA-DRB1 * Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS)~     have been linked to risk of MS and the response to treatment with immunomodulators. This~     research aims to estimate the risk that confers some variations in the sequence of these~     genes.~   "
21959|NCT02769754|"~     This prospective randomized study aims to determine the influence of the use of local~     hemostatic on the incidence of local complications derived from the edge of transection:~     biliary fistula or bleeding, after scheduled hepatic resection.~   "
21960|NCT02769741|"~     This study will assess the nutritional effect of cashews on LDL-C concentrations and~     secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and~     women with moderately elevated cholesterol.~   "
21961|NCT02769728|"~     The aim of the study is to explore short and longer-term effects of the Endobarrier™~     implantation on insulin resistance and beta-cell function assessed by repeated Botnia~     clamps. In addition changes in gut peptides and gut permeability after implantation of a~     removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with~     sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in~     body weight and body composition, the change in global cardiovascular risk from baseline to~     12 months, estimated using the UKPDS risk engine will be recorded.~   "
21962|NCT02769715|"~     Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting~     technique, a time-consuming and very laborious manual technique. Recently, fabricating~     removable partial dentures using computer designing and laser sintering techniques have been~     introduced. The purpose of this study was to evaluate the patient satisfaction with new~     computer-generated removable partial dentures and compare it to the traditional removable~     partial dentures.~   "
21963|NCT02769702|"~     Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis~     often responds adequately to topical corticosteroids, there are many patients for which this~     treatment is either inadequate or not tolerated. A patient with inadequate response to~     treatment would manifest uveitis activity by slit lamp examination determination of anterior~     chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension~     (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid~     administration, leading to glaucoma and permanent visual loss. Moreover, systemic~     corticosteroids may be required at a dose unsafe for chronic administration. In these~     situations, an immunosuppressive medication is often added as a steroid-sparing agent. If~     and when there is clinical response to the added immunosuppressive, the oral and/or topical~     corticosteroid dose can be reduced or eliminated to avoid toxicity.~      There are several reasons for believing that Acthar might be beneficial in the treatment of~     uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has~     another important mechanisms of action mediated by its binding of melanocortin receptors.~     Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In~     animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory~     cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages,~     there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion~     molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is~     down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1~     and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated~     by melanocortin receptor binding by Acthar.~   "
21964|NCT02769689|"~     Progressive multifocal leukoencephalopathy (PML) is the most feared complication when~     natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of~     PML increases after 18 months of treatment. When switching from NTZ to another disease~     modifying treatment (DMT) in these MS patients with an active disease, there is a high risk~     of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary~     before initiating a new DMT.~      The primary purpose of this protocol is to investigate the impact of high dose of oral~     methylprednisolone, given once a month during the washout period between NTZ and Fingolimod~     (FTY).~   "
21965|NCT02769676|"~     The current postpartum care model of a single visit 4-6 weeks after delivery does not~     optimally address contraceptive needs. By this visit, many women have resumed sexual~     activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In~     addition, many women with pregnancy-related Medicaid lose insurance coverage at this time,~     making it difficult to obtain long-acting reversible contraception (LARC) if desired.~     Therefore, an earlier postpartum visit may remove barriers to improve access to LARC~     thereby, reducing unintended and rapid repeat pregnancy. Our primary objective is to~     determine whether an additional 3-week postpartum visit, compared to usual postpartum care,~     will affect the initiation of LARC by 6 weeks postpartum.~   "
21966|NCT02769663|"~     The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep~     apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared~     to healthy controls matched on age, sex and educational level. Factors related to cognitive~     complaints will also be assessed, including anxiety and depressive symptoms, complaints of~     fatigue and sleepiness, quality of life, psychological coping strategies and objective~     measures of cognition. Patients starting treatment for sleep apnea (continuous positive~     airway pressure or mandibular repositioning device) will be reassessed on all measures after~     6 months of treatment to study the impact of treatment as usual on cognitive complaints and~     its related factors.~   "
21967|NCT02769650|"~     The hypothesis of this study is that Stress-MRI is a clinically significant method of~     myocardial perfusion assessment after coronary angioplasty with stenting of right coronary~     artery (RCA) chronic total occlusion (CTO) is performed.~   "
21968|NCT02769637|"~     Mucus in the airways of patients with CF represents an area for bacteria proliferation,~     microbial infection and inflammation. Similar to the lung, the esophagus provides an~     environment for bacterial to grow. The overall goal of this proposal is to characterize the~     esophageal microbiota of children with CF that are treated or untreated with acid blockade~     medication and to measure its possible impact on respiratory disease to develop novel~     treatment strategies.~   "
21969|NCT02769624|"~     In this pilot study investigators propose to explore the effects of a locally delivered~     inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary~     blood flow, venous pressure response and vascular function in stable Fontan patients.~     Investigators will also assess the effects of resting and acute rises in exercise induced~     systemic venous pressure on liver stiffness and will also assess whether treprostinil will~     attenuate the acute stiffness increase that investigators expect to see. This will be a~     prospective, randomized, double-blinded placebo controlled, crossover trial. Following~     recruitment and informed consent, each participant will undergo three study visits,~     including baseline testing (visit 1), followed by two sets of exercise and vascular function~     tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.~   "
21970|NCT02769611|"~     This study evaluates the effect of ruboxistaurin for its safety, tolerability, and~     effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of~     oral ruboxistaurin.~   "
21971|NCT02769598|"~     Fighting against the pain caused by the disease or by the diagnostic and therapeutic~     procedures for children is a daily and essential concern of health care in the pediatric~     sector. The quantification of pain is needed to effectively adjust analgesic therapy while~     limiting the side effects of treatment. Nowadays many scales are validated for children, but~     they are based on one-off measures and hetero assessments are often subjective and dependent~     on many factors including the presence of staff to children's sides.~      Recent developments in the analysis of the cardiac signal in real time under the influence~     of autonomic control, have led to the development of a new painful stress quantification~     index. A monitor has recently been developed and provides an index of nociception and~     analgesia (ANI index). The validation of this nociception index has not been validated for~     pediatric care in a sector where particular attention is given to control pain.~      The main purpose of this study is to show the consistency of the index compared to a~     validated pain scale and used routinely in non-sedated children hospitalized in pediatric~     intensive care units. The caregiver will have the opportunity to fine tune the effective~     treatment.~   "
21972|NCT02769585|"~     Randomized study evaluating self-hypnosis versus certified diabetes educator training for~     weight loss in type 2 diabetics.~   "
21973|NCT02769572|"~     This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial~     to evaluate the efficacy of moxibustion for osteoarthritis of the knee.~   "
21974|NCT02769559|"~     The data gathered here will be used to evaluate the efficacy and safety of the mammary~     reduction in patients with macromastia.~   "
21975|NCT02769546|"~     The primary objective is to administer a cross-sectional survey to directly compare the~     differences patients and physicians hold regarding ovarian cancer prognosis and survival,~     complications arising from treatment, and counseling on advance directives, living wills,~     palliative care, and hospice services. Overall, the project will pinpoint opportunities for~     better patient physician communication regarding prognosis and end-of-life care and allow~     for more informed and tailored decision-making.~   "
21976|NCT02769533|"~     This study is focusing on patients presenting with suspected malignancies of the pituitary~     gland who are considered to be good surgical candidates.The primary end-point of the study~     is to determine the sensitivity of OTL38 uptake and expression in identifying those nodules~     when excited by an imaging probe.There will be a single dose of 0.025 mg/kg for intravenous~     injection over approximately 60 minutes, two to three hours, prior to surgery.~   "
21977|NCT02769520|"~     The purpose of this study is to determine whether pembrolizumab, when given after salvage~     surgery, is effective in increasing the time a person with squamous cell cancer of the head~     and neck remains disease-free following locoregional disease recurrence.~   "
21978|NCT02769507|"~     The present study aims to investigate whether transcranial direct current stimulation (tDCS)~     reduces auditory hallucinations in patients with psychosis. In addition, the neuronal~     changes of tDCS will be examined.~   "
21979|NCT02769494|"~     This study aims at evaluating efficacy and safety of topical using Mesalazine~     Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's~     disease.~   "
21980|NCT02769481|"~     The purpose of this study is to investigate the effect of bexagliflozin compared to~     glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in~     subjects with type 2 diabetes mellitus (T2DM).~   "
21982|NCT02769455|"~     Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional~     content at a glance, in order to help consumer make informed choices, has been identified as~     of major interest by public health specialists of many countries. French health authorities~     are currently considering the endorsement of a FOP nutrition label, but no specific format~     has yet been determined. A more simplified FOP nutrition label has been put forward in~     France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label~     is well perceived and understood by consumers. The introduction of a FOP nutrition labelling~     system has been identified as challenging in certain population groups, due to their lower~     level of nutrition knowledge and unhealthier diets.~      The aim of the investigators is to evaluate the impact of FOP nutrition labels on the~     nutritional quality of the shopping cart in an online experimental supermarket in various~     nutritionally at-risk populations. Two FOP systems will be tested to a control situation~     without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers~     and present in a portion of food products sold in France, and the 5-Colour Nutrition Label~     (5-CNL).~      Three 3 arm parallel arm randomized trials are designed, each targeting a specific~     population. The methodology and interventions are identical across trials. Trials will be~     conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3)~     Older subjects with identified chronic diseases. The intervention consists in the~     application of FOP nutrition labels on all food products, either the RI label, currently in~     use in some products in France, and the 5-CNL label. A control situation with no FOP will~     also be used. Participants will be asked to perform a shopping session in an experimental~     online supermarket, in one of the three experimental conditions described. The main outcome~     will be the overall nutritional quality of the shopping cart, assessed using the mean Food~     Standards Agency Nutrient profiling system score of the items in the shopping cart.~   "
21983|NCT02769442|"~     A randomized prospective comparison of two FDA approved intravenous catheters in the~     emergency department setting. The Terumo SurFlash Plus offers novel technologies that~     promise to increase intravenous access success rates and decrease blood contamination of the~     insertion site. This study would analyze these properties in our busy, urban emergency~     department setting where time and safety of intravenous access are most critical.~   "
21984|NCT02769429|"~     This study will answer the question whether there is a difference in the effects and~     complication rates of ultrasound guided continuous interscalene block (CISB) and nerve~     stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is~     to evaluate the differences in efficacy and side effects - if any.~   "
21985|NCT02769416|"~     The NCTT is a prospective, multicenter, observational research network for subjects with~     chronic spinal cord and/or chronic traumatic brain injury.~   "
21986|NCT02769403|"~     The purpose of this research study is to determine if using HeartMath's biofeedback with~     emWave Pro daily mindfulness practice: is a practical and effective intervention to improve~     job satisfaction and performance of physicians, advance practice clinicians, and nurses;~     improves patient satisfaction; and affects resting blood pressure and heart rate when~     comparing baseline to follow-up measures.~   "
21987|NCT02769390|"~     The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block~     provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone~      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years~     old, following eletive hypospadias surgery, under general anesthesia and caudal epidural~     block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus~     clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg.~     The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure~     will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs,~     activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at~     24 h will be avaiable.~   "
21988|NCT02769377|"~     To determine if glucometer combined with mobile-phone based data transfer system would be~     useful for patient diabetes to manage their glycemic control.~   "
21989|NCT02769364|"~     Decision-making for treatment of metastatic breast cancer after the second line of~     chemotherapy was limited by the lack of established predictive factors of benefit for~     further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating~     an overall survival improvement in the third-line setting or beyond. The purpose of this~     study was to define the clinical profile of metastatic breast cancer participants achieving~     long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.~   "
21990|NCT02769351|"~     In patients with advanced volume overload, minimally invasive ultrafiltration treatment in~     the acute phase can have a positive effect on clinical outcome. The aim is to collect~     treatment data in the context of a prospective registry of the safety and performance of~     minimally invasive ultrafiltration. The data will be recorded via an electronic case report~     form (eCRF); the eCRF runs on a server located in Germany and complies with current data~     protection regulations. It is intended to include about 300-500 patients with advanced~     volume overload at a minimum of 10 sites. In addition, data on a disease management~     programme (in-body measurement and home monitoring) will be recorded in up to 40 of these~     patients. The treatment data from each patient will be recorded over 12 months. An interim~     analysis will be performed after 150 patients have been observed for 6 months. The knowledge~     about ultrafiltration in volume overload obtained from the registry, in some cases in~     combination with a disease management programme, is intended to improve the body of~     evidence. In addition, the data will be used for hypothesis generation.~   "
21991|NCT02769338|"~     This program will seek to implement a quality improvement program to improve the care of~     Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The~     investigators will evaluate the implementation and effectiveness of the quality improvement~     program.~   "
21992|NCT02769325|"~     This is a double blinded, randomised controlled trial that will compare atropine to placebo~     for postoperative pain in laparoscopic gynaecological surgery~   "
21993|NCT02769312|"~     The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta~     Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with~     PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary~     outcome measures focusing on changes in PTSD symptom severity and quality of life and~     social/occupation functioning.~   "
21994|NCT02769299|"~     The overall objective of this proposal is to determine the utility of sensitive imaging and~     biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation~     doses to the heart. We will focus specifically on patients receiving photon or proton chest~     radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury,~     as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.~   "
21995|NCT02769286|"~     Treatment efficacy of osimertinib will be assessed in patients with lung cancer harboring~     activating epidermal growth factor receptor (EGFR) mutations (cohort 1) and those harboring~     T790M (cohort 2) which were detected from circulating tumor DNA~   "
21996|NCT02769273|"~     Prospective, international, multi-center, single arm, observational study to continue to~     assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial~     femoral and/or popliteal arteries according to the Instructions for Use in a broad,~     real-world, claudicant or ischemic rest pain patients population per the institution's~     standard practice.~   "
21997|NCT02769260|"~     The purpose of this study is to determine in situ the bacterial viability, thickness and~     bacterial diversity of a biofilm formed on different substrates in comparison to a naturally~     tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral~     hygiene measures may influence the development of the PL-Biofilm.~   "
21998|NCT02769247|"~     To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and~     pain of patients undergoing intrauterine device insertion.~   "
21999|NCT02769234|"~     In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with~     mild Alzheimer's disease and the other healthy controls, were tested with a hand-held~     EEG/ERP system to determine if the cohorts could be discriminated using the EEG/ERP~     measures. This study proposes to retest the AD cohort 18-60 months after their first test to~     characterize the change in EEG/ERP measures correlated with the longitudinal change in~     neuropsychological testing.~   "
22000|NCT02769221|"~     This study compare the intubation success rate between video laryngoscope and rigid video~     stylet in cervical spine surgery patients. Half of patients will receive endotracheal~     intubation by video laryngscope, other half of patients will receive endotracheal intubation~     by rigid video laryngoscope.~   "
22001|NCT02769208|"~     The purpose of this study is to evaluate whether two different central air purification~     technologies reduce air pollutant exposure and beneficially influence health as evaluated~     with a suite of biological markers related to cardiovascular and respiratory disease risk.~   "
22002|NCT02769195|"~     This study is a secondary, pooled analysis of two completed phase 3 clinical trials:~      (i) GSK-HGS1006-C1056 (BLISS-76): A Phase 3, Multi-Center, Randomized, Double-Blind,~     Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,~     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus~     Erythematosus (SLE); and,~      (ii) GSK-HGS1006-C1057 (BLISS-52): A Phase 3, Multi-Center, Randomized, Double-Blind,~     Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,~     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus~     Erythematosus (SLE)~      The study will assess the discriminant validity of a proposed measure of low disease~     activity (the Lupus Low Disease Activity State, LLDAS) in patients with SLE.~   "
22003|NCT02769182|"~     The main objective of this research is to develop and validate a technology-based solution~     that addresses the diminished mobility, increased fall risk and impaired cognitive function~     that are so common among older adults, enabling them to live longer successfully and~     independently.~   "
22004|NCT02769169|"~     The purpose of this study is to determine whether double-dose Ranibizumab are effective to~     regress the polyps and benefit to the visual outcome in the polypoidal choroidal~     vasculopathy (PCV).~   "
22005|NCT02769156|"~     This pilot and feasibility study is focusing on patients presenting with suspected~     malignancies of the lung and pleura who are considered to be good surgical candidates. The~     primary end-point of the study is to determine the sensitivity of OTL uptake and expression~     in identifying those lung and pleural nodules when excited by an imaging probe. There will~     be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two~     to three hours, prior to surgery.~   "
22006|NCT02769143|"~     Women in the postmenopausal period suffer hormonal changes that contribute to a number of~     negative factors to health, such as reduced bone mineral density and loss of muscle mass,~     which contribute to the increased incidence of falls and consequent risk of fractures. Among~     the possibilities to alleviate these symptoms are mainly drug treatment and the systematic~     practice of physical exercise. Exercise stands out for not offering adverse effects. One~     form of exercise that has been recently investigated is the whole body vibration, another~     form of exercise well accepted by the population is the Pilates method.~      Taking into account the lack of literature on the benefits of vibration training; and also~     the Pilates method on bone mineral density, muscle strength, flexibility, postural balance,~     fear of falling and the quality of life of postmenopausal women, explains the importance of~     this work.~   "
22007|NCT02769130|"~     This pilot study evaluates the safety and feasibility of losartan in pediatric patients with~     pulmonary vein stenosis.~      It is an open label single arm interventional study. The patient population involves~     pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given~     losartan for 1 year. Outcomes include measures of safety/adverse events and progression of~     pulmonary vein stenosis.~   "
22008|NCT02769117|"~     The purpose of this study is to evaluate sequential fracture healing with radius/ulna~     fractures and compare ultrasound to radiographs.~   "
22009|NCT02769104|"~     The investigators designed this study to investigate the effect of aromatase inhibitors (AI)~     plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone~     receptor-positive breast cancer.~   "
22010|NCT02769091|"~     The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on~     liver health and liver fat content in patients with T2DM who also have Nonalcoholic~     Steatohepatitis (NASH).~   "
22011|NCT02769078|"~     The overall objective of this proposal is to execute a real-world database analysis to~     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)~     patients in the U.S.~   "
22012|NCT02769065|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of~     TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally~     in healthy participants and participants with mild cognitive impairment (MCI) or mild~     Alzheimer disease (AD).~   "
22013|NCT02769052|"~     Objective: to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation~     (TENS) self-applied for the treatment of pain and the impact of this therapy on~     biomechanics, quality of life and sexuality of women with deep endometriosis.~   "
22797|NCT02758769|"~     Examine the effectiveness and safety of the abatacept administration in biologic-naïve~     rheumatoid arthritis patients who have moderate disease activity despite treatments with~     conventional synthetic disease modified anti-rheumatic drugs.~   "
22014|NCT02769039|"~     Treatment resistant motor features, such as postural instability and freezing of gait are~     common in people with Parkinson's disease and major contributors to morbidity and mortality.~     This project will use sleep studies, quantitative motor assessments and magnetic resonance~     imaging to examine the relationship between abnormally increased muscle activity during~     rapid eye movement sleep and the development and progression of treatment-resistant postural~     instability and gait disturbances. Specifically, the investigators will test the hypothesis~     that anticipatory postural adjustments (weight and pressure shifts) during gait initiation~     are significantly reduced in people with Parkinson's disease who have abnormally elevated~     muscle activity during rapid eye movement (REM) sleep compared to individuals will~     Parkinson's disease whose REM sleep muscle activity is normal. In addition, the~     investigators will test the hypothesis that the level of RSWA at baseline is predictive of~     measures of motor decline (postural stability and gait) and alterations in the structure and~     function of locomotor brainstem networks. Since sleep disorders can emerge years before a~     diagnosis of Parkinson's disease, establishment of a link between sleep and~     treatment-resistant posture and gait disorders will help identify individuals at risk of~     developing these disabling motor features of disease.~   "
22015|NCT02769026|"~     This multicenter study will validate a panel of serum, imaging, and clinical biomarkers to~     classify patient outcome early after out-of-hospital pediatric cardiac arrest. Results are~     expected to have a positive and immediate impact in advancing clinical care and outcomes for~     these children. This work will provide clinicians, families, and researchers with superior~     tools to assess the severity of brain injury early after resuscitation in order to know who~     is at risk of brain injury and may benefit from neuroprotective interventions, to monitor~     response to these interventions, to plan rehabilitation strategy, and to optimize the design~     of research studies that test novel interventions to improve neurological outcome after~     cardiac arrest.~   "
22016|NCT02769013|"~     Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in~     an area of co endemicity.~   "
22017|NCT02769000|"~     Evaluate safety and toxicity/adverse events associated with delivery of low dose whole brain~     irradiation in patients with early Alzheimer's dementia according to the National Institute~     of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and~     Related Disorders Association (NINCDS-ADRDA) criteria.. As a secondary goal it will~     establish whether or not the intervention with low dose whole brain irradiation stabilizes~     or decreases cerebral amyloid deposits and whether these correlate with the recognized~     progression of Alzheimer's dementia. The investigators will also collect information from~     the FDG and Amyvid® PET Scans to determine if there is any correlation between~     neurocognitive/quality of life scores and changes in amyloid plaque size, number and~     location.~   "
22018|NCT02768987|"~     Physical inactivity occurs among 65% to 95% of youth with type 1 diabetes (T1D) and based~     upon limited evidence may contribute to the rapidly growing incidence of overweight among~     this population. The purpose of the present study is to pilot test a 12-week intensive~     lifestyle program for adolescents with overweight and T1D utilizing group exercise classes~     adapted for this population, supplemented with coping skills training and diabetes~     self-management education to address problem solving behaviors that limit their physical~     activity and weight control. Our primary aim is to evaluate the changes in physical activity~     adherence, anthropometrics, and self-management behaviors following this program among~     sedentary adolescents with T1D and overweight (n=25, OW) compared with sedentary adolescents~     with T1D and normal weight (n=25, NW). We hypothesize that the OW group will achieve improve~     physical activity adherence and anthropometrics to the same or greater extent as the NW~     group and previous Bright Bodies cohorts, and that these changes will correlate with~     improved exercise-related problem solving. Our secondary aim is to evaluate changes in~     adipocytokines and epigenetic factors related to the etiology of overweight/obesity~     following our physical activity intervention. We hypothesize changes in these biomarkers~     will correlate with changes in anthropometry variables and partially explain any differences~     in response between the groups and individuals should those occur.~   "
22019|NCT02768974|"~     This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with~     active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and~     randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.~   "
22020|NCT02768961|"~     The objectives of this study are:~        1. To perform a systematic screening and evaluation of the prevalence of infection by~          hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV)~          in the prison population.~        2. To perform an adequate characterization of patients and the characteristics of HCV~          infection in this population.~        3. To evaluate the effectiveness and security in the prison population of an~          interferon-free antiviral regimen.~        4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of~          persistent infection, reinfection and super-infection in a prison population, in the~          short, medium and long term.~   "
22021|NCT02768948|"~     The severity of the diabetic nephropathy is proportional to proteinuria rate and degree of~     renal interstitial fibrosis. Despite many treatments available today, diabetic nephropathy~     is responsible for a quarter of cases of end-stage renal disease (ESRD) requiring the use of~     renal replacement therapy or kidney transplantation. It develops as follows: chronic~     hyperglycemia of diabetes abyss renal glomeruli that allow proteins in the urine room. In~     response, the tubular epithelium produces monocyte chemoattractant protein-1 (MCP-1) that~     attracts monocytes circulating in the renal interstitium. Monocytes then differentiate into~     M1 or M2 macrophages. M1 macrophages increased MCP-1 production while M2 macrophages produce~     transforming growth factor beta (TGF-β) pro-fibrogenic. Renal fibrosis is negatively~     correlated with the glomerular filtration rate itself proportional to the number of~     nephrons. The decrease in the number of nephrons majorises secondarily proteinuria by the~     onset of focal segmental glomerulosclerosis lesions. Production of MCP-1 increases with the~     renal proteinuria because M1 macrophages earning kidneys reinforce the production of MCP-1,~     and fibrosis worsens because M2 macrophages infiltrate in turn kidneys and produce TGF -β.~      A way of limiting renal fibrosis would be to decrease renal monocytic infiltration by~     promoting the differentiation of monocytes towards macrophages M2. Although more numerous,~     M2 macrophages no longer benefit the kidneys because the decline of M1 macrophages decrease~     renal MCP-1 production. Ex vivo IL1-β orients the differentiation of monocytes towards~     macrophages M1 and IL-4 to M2. By cons in vivo, the differentiating factors are poorly~     known. It is remarkable that metformin and telmisartan increase M2 macrophages M1~     macrophages and decrease, respectively, in humans and mice. Moreover, telmisartan reduces~     proteinuria more than losartan in diabetic nephropathy in humans and Metformin decreases the~     amount of TGF-β intra-renal mice. This effect of telmisartan is independent of the type 1~     receptor of angiotensin II (AT1R) since it is not obtained with losartan.~      Telmisartan is a partial agonist of peroxisome proliferator-activated receptor gamma~     (PPARgamma), the working assumption is that telmisartan fosters the transition of monocytes~     to macrophages M2 form, and limit the recruitment of more monocytes in the kidneys and~     therefore proteinuria and renal fibrosis. To show this, it will be compared the ability of~     monocytes to differentiate ex vivo in M1 or M2 macrophages in diabetic nephropathy patients~     treated with losartan or telmisartan then it will characterize the role of PPARgamma in the~     monocyte / macrophage transition. Finally, it will be compared the urinary excretion of~     amino terminal propeptide of procollagen type 3 (PIIINP), considered a marker of renal~     fibrosis in patients receiving losartan or telmisartan.~   "
22023|NCT02768922|"~     This study aims at contributing with scientific evidence to the field of aphasia~     telerehabilitation. In Norway today, there is an unmet need for language training in post~     stroke aphasia and not all patients are offered language training. Early start of aphasia~     rehabilitation and satisfying intensity do not seem to be standard clinical practice.~     Language training by telemedicine could improve this situation, and this study seeks to~     answer the question whether aphasia rehabilitation delivered by telemedicine can improve~     language function in aphasia early post stroke.~   "
22024|NCT02768909|"~     Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in~     Venezuela.~   "
22025|NCT02768896|"~     Voltage fluctuation as a result of brain activity will be recorded into the computer using~     an EEG device.~   "
22026|NCT02768883|"~     The immediate goal of the Imperial County CER Asthma project is to identify strategies to~     improve asthma control among children 0-17 years old and the asthma control behaviors of~     their families, their health care providers, and the communities in which they live. Our~     long-term goal is to improve the quality of life of children with asthma and potentially~     reduce families' economic and social burdens of uncontrolled asthma~   "
22027|NCT02768857|"~     This study evaluated the effects of an integrated program of touch-observation and~     task-based mirror therapy on sensorimotor function in nerve injury patients. Before the~     return of protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the~     participants received 15 minutes of mirror therapy program, followed by 20 minutes of~     regular hand therapy and 20 minutes of physiotherapy.While the other half received 15~     minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20~     minutes of physiotherapy in each treatment session. Once the patients had regained the~     protective sense (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative~     sensory reeducation program was started for the participants in both groups. The hypothesis~     was that using the mirror therapy for sensorimotor reeducation in the early phase after~     nerve repair would yield better results with regard to the returning of sensation,~     sensorimotor control ability and hand function than using a classical reeducation program~     alone.~   "
22028|NCT02768844|"~     The overall purpose of this project is to to quantify the physiology of neonatal drug~     withdrawal and develop non-pharmacological techniques to help improve the therapeutic~     management of Neonatal Abstinence Syndrome (NAS).~   "
22029|NCT02768831|"~     In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in~     pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal~     perfusion while an inadequate seal may impact ventilation and potentially increase the risk~     of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and~     effective tracheal seal. The two ways to measure that are to hold CPAP while listening for~     an audible leak and measuring the difference between the inspired and expired tidal volumes~     (TV). This is a prospective study to compare these two methods used to create a tracheal~     seal and measure the intracuff pressure after a satisfactory tracheal seal is established.~   "
22030|NCT02768818|"~     The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing~     maternal microbiota and preventing gestational diabetes in overweight and obese women.~      To achieve these goals, obese (BMI> 30 kg/m^2) or overweight (BMI> 25 kg/m^2) pregnant women~     with risk factors were enrolled in the study and randomized to the supplementation with the~     probiotic VIVOMIXX® or with placebo.~      The endpoints of this study are to evaluate if the dietary supplementation with the~     probiotic VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli)~     and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if~     this if this is linked to an improvement of the intermediate metabolism (positive Oral~     Glucose Tolerance Test at 24-26 weeks).~   "
22031|NCT02768805|"~     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the~     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The~     study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent~     VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure~     criteria. The study will also help to define the optimal dose, establish potential~     competitive advantages, and support the design of future studies.~   "
22032|NCT02768792|"~     Rationale:The purpose of this research study is to test the effectiveness of the standard~     high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab~     on day 14 as induction therapy in patients with relapsed and refractory acute myeloid~     leukemia (AML). Patients who achieve a response to treatment will continue on the study drug~     (pembrolizumab) every 3 weeks for up to 1 year maintenance therapy.~      Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is~     being studied in a clinical research trial together with standard chemotherapy (HiDAC) in~     relapsed and refractory AML. The study will also explore the association between potential~     immune biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have~     blood and bone marrow samples collected before and after treatment to determine the dynamic~     nature of immune signatures pre and post-treatment.~   "
22033|NCT02768779|"~     Hair samples from subjects on antiretroviral therapy, both HIV- and HIV+ patients with HIV~     RNA <50copies/mL for >6 months will be analyzed to investigate the influence of race, hair~     color and hair treatment on ARV response.~   "
22034|NCT02768766|"~     The purpose of this study is to find out what effects, good and/or bad, intermittent dosing~     of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug~     that blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal~     melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from~     growing.~   "
22035|NCT02768753|"~     The purpose of this study is to compare the therapeutic effects between the axillary~     bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic~     thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the~     two approaches.~   "
22036|NCT02768740|"~     We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult~     medical intensive care units. Patients presenting septic shock were rapidly administered one~     of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during~     seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300~     mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of~     treatment.~   "
22037|NCT02768727|"~     The dual objectives of this study are to determine if the phenomenon of neural inertia is~     present in humans and to determine whether the order of neurocognitive function is invariant~     among anesthetic agents. This study will enroll 12 healthy volunteers, ages 20-40 years, who~     will receive xenon gas (concentrations ranging from 0% to 75%) delivered via inhaled route~     through the ENHANCER 3000.~   "
22038|NCT02768714|"~     This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least~     180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be~     randomised (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90)~     in 8 to 10 sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive~     chemotherapy (21 days per cycle).~   "
22039|NCT02768701|"~     This phase II, single-arm, multicenter study will evaluate pembrolizumab therapy in patients~     with advanced triple-negative breast cancer (TNBC) who have received at least one prior line~     of therapy.~   "
22040|NCT02768688|"~     This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5~     healthy human subjects as visualized by diffusion tensor MRI. The study is designed to~     measure clinically established, safe imaging of DTI and cerebral blood flow at baseline,~     during a continuous intravenous infusion of dexmedetomidine at doses designed to produce~     anesthesia-induced unconsciousness to simulate natural sleep, and again on return to~     wakefulness.~   "
22041|NCT02768675|"~     The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility~     assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal~     kyphotic corrective constructs.~   "
22042|NCT02768662|"~     This is an open-label extension study of a single intratympanic injection of OTO-104 given~     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy~     study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of~     OTO-104) in order to be eligible for this open-label extension study.~   "
22043|NCT02768649|"~     The purpose of this study was to assess the safety and tolerability of injections of~     RBP-7000 in subjects with stable schizophrenia~   "
22044|NCT02768636|"~     Heart rate variability can represent physiological and psychological levels via sympathetic~     and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can~     effect on physiological and psychological with many good results. The pathways to explain~     about its effect had been studied in many contexts. Effect to autonomic nervous function by~     Omega-3 is our interesting question.~   "
22045|NCT02768623|"~     Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4~     million Canadians and over 300 million people worldwide. Unlike most other chronic diseases,~     asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is~     also the leading cause of hospitalization for children in Canada and is a significant cause~     of school and work absenteeism. Though asthma is generally considered a chronic disease, it~     can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition.~     Effective management of asthma can prevent exacerbation and more severe negative health~     consequences. In fact, estimates show that over 80% of the asthma-related deaths could be~     prevented through proper education. However, evidence also shows that over 55% of patients~     with moderate to severe asthma do not have their asthma symptoms under control, despite~     regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma~     action plan from their physicians, although such plans are associated with fewer ER visits,~     lower hospitalization rates and improved lung function. Hence, there is a clear opportunity~     to improve the management of asthma and reduce the incidence of related complications.~      Given the scientific evidence of pharmacists effect on asthma management there is a strong~     rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians~     suffering from this chronic disease. However, the implementation of such a program should be~     preceded by a pilot test to ensure that the program parameters are optimized to drive~     improved patient outcomes and maximum quality of service. The primary goals of this research~     project are to examine the impact of a pharmacist led asthma management intervention on~     patient health outcomes and to determine the optimum program structure to ensure quality of~     service delivery.~      This study employs a mixed-methods study design. Investigators will begin with a cluster~     randomized controlled trial and end with exit interviews.This study will consist of a~     prospective, randomized controlled trial conducted in the community setting. A total of 12~     pharmacies across the Greater Toronto Region will be recruited for this study. Each of these~     pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the~     control group. All data will be analyzed using statistical software. Significance level will~     be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard~     deviation for the number of patients will be reported. There is a low perceived risk for~     this study; however, the investigators will take every precaution to ensure this study is~     conducted in an ethical manner, including protecting patient confidentiality and anonymity.~   "
22046|NCT02768610|"~     Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and~     analgesic properties. This study was designed to evaluate the inhibitory effects of~     preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal~     intubation in elderly patients being treated for hypertension.~      Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of~     Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly~     and assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg~     dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic~     blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart~     rate (HR) were recorded preoperatively at ward, immediately after study drug administration,~     and at 1, 3, and 5 minutes after endotracheal intubation.~   "
22047|NCT02768597|"~     The study will compare the outcome of primary reverse shoulder arthroplasty using the~     Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm)~     glenosphere with either a +2 mm or a +6 mm offset.~   "
22048|NCT02768584|"~     Clarify the determinants of the construction of a Therapeutic Alliance (AT) between~     paramedical staff (nurses and caregivers ) and adult patients in a functional unit of~     full-time general psychiatric Whether the quality of Therapeutic Alliance influences the~     continued support outpatient , after completion of full-time hospitalization.~   "
22059|NCT02768441|"~     The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release~     dexamphetamine will be studied. These individuals have received this medication before in a~     previous trial where the pharmacodynamics were investigated. This trial will last 5~     consecutive days during which blood samples will be drawn for pharmacokinetics analyses.~     Dried blood spots will also be collected for the clinical validation of the bioanalytical~     method wherein these are used.~   "
22060|NCT02768428|"~     Objective: To compare the effectiveness between Video and Handbook on providing knowledge of~     TACE.~      Study Design: A prospective, randomized, controlled trial.~   "
22183|NCT02766816|"~     Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing~     World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This~     study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV.~     This study will also assess lot-to-lot consistency among three lots of BBio bOPV.~   "
22049|NCT02768571|"~     This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized,~     double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute~     stroke patients with severe motor involvement. Primary objective is to demonstrate the~     efficacy of porcine brain peptide to improve motor recovery measured by the improvement~     ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) /~     score of FMA at baseline) in patients with subacute stroke. Secondary objectives are to~     evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke~     patients with severe motor involvement randomized to administration of Cerebrolysin combined~     with rehabilitation for 3 weeks show better outcome on global function (Korean version~     Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke~     Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean~     version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm~     Test, ARAT; Box and block test, B&B) and neuroplasticity measure (resting-state functional~     MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after~     stroke.~   "
22050|NCT02768558|"~     Patients with Stage III unresectable non-small cell lung cancer will receive thoracic~     radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for~     a year.~   "
22051|NCT02768545|"~     NPC1L1 is a key transporter in the enterohepatic cycle of cholesterol. Initial in vitro and~     in vivo data show that blocking this receptor with ezetimibe results in delaying infection~     in these models. The investigators hypothesize that HCV has an enterohepatic cycle, being~     secreted in bile and reabsorbed either in the canalicular membrane or in the intestine by~     association with NPC1L1, following a path similar to the cycle of cholesterol in humans. To~     prove this hypothesis the investigators propose to assess the effect of ezetimibe treatment~     in HCV infected individuals undergoing liver transplantation to avoid or delay HCV~     infection. For this purpose, the investigators propose to administrate ezetimibe 10 mg/d for~     12 weeks to 12 patients with chronic hepatitis C infection listed for a liver~     transplantation.~   "
22052|NCT02768532|"~     Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease~     by inducing and maintaining clinical response/remission. The French marketing authorization~     was obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis~     Factor) agents.~      For Crohn's disease patients treated with vedolizumab, a strong association between~     vedolizumab serum levels and clinical response to induction and maintenance was demonstrated~     by anterior studies.~      It could be of paramount interest to early identify Crohn's Disease patients under~     vedolizumab who will be responders to vedolizumab induction and to identify those who will~     achieve clinical remission under maintenance therapy with vedolizumab.~      Researchers decided to assess the clinical response to vedolizumab induction at week 10. For~     clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be~     infused at week 10 and then every four weeks.~   "
22053|NCT02768519|"~     The purpose of this study is to determine the indicative bioavailability of a single oral~     dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after~     oral dosing.~      Eleven male and female healthy participants aged 45 years and over will be entered into this~     phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to~     evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of~     OTS167 when administered by the oral route. Correlative studies include evaluation of safety~     endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate~     the safety and tolerability of oral dosing from lower dose.~   "
22054|NCT02768506|"~     Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a~     variable limb length between 250 cm and 300 cm or gastric bypass.~      Results on weight loss, comorbidities resolution, complications, re-operations, need of~     supplements are registered.~   "
22055|NCT02768493|"~     The recent study revealed that high-volume caudal block caused reduction in cerebral blood~     flow velocity and cerebral oxygenation. It was supposed to be associated with increased~     intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of~     diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to~     evaluate the effect of caudal block on intracranial pressure in pediatric patients~     undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal~     block before urologic surgery will be divided into high dose group (n=40) and low dose group~     (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15%~     ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0~     ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath~     diameter after caudal block measured by optic nerve ultrasonography.~   "
22056|NCT02768480|"~     The study is a randomized clinical trial, controlled, open label that aimed to compare two~     groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by~     primary care (control group) and patients followed by primary care and supported by phone~     calls (intervention group).~   "
22057|NCT02768467|"~     Prior studies have been performed to understand the optimal way to minimize the morbidity~     rate of buccal mucosa. While some studies have reported primary closure to be inferior to~     healing by secondary intention, this appears to be true for large defects greater than 2 cm~     in width. For small defects for which the wound can be closed without tension, the most~     recent study has shown improved pain outcomes in the immediate post-operative setting,~     although no difference is seen long term whether or not the wound was primarily closed.~     However, for larger defects, standard practice is to allow delayed healing by secondary~     intention.~      The use of Alloderm graft placement for donor site coverage was first described in~     Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The~     only study to report the use of Alloderm failed to find a significant improvement in patient~     outcomes; however, very small defects were included in this study and the control group~     underwent primary closure, which has been shown to be inferior for large defects.~     Importantly, no increase in post-operative pain was noted, although there was some increased~     swelling reported. From experience, patients with moderate and large (>2 cm width) defects~     following buccal mucosa harvest benefit from Alloderm placement with decreased~     post-operative pain, more rapid resumption of normal diet and mouth function with no~     associated increase in morbidity of the procedure. This study aims to determine whether this~     is a reliable improvement in technique.~      This study will clarify how the cheek heals after the buccal mucosa is removed during~     reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix~     or no stitches after the surgery. Subjects will be evaluated up to six months to determine~     if the outcomes of the tissue matrix graft are better for the subject.~   "
22058|NCT02768454|"~     To study the outcome of antibiotics stewardship~   "
22076|NCT02768220|"~     Single-center open-label multiple dose randomized two period cross-over study to examine~     Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin~     administration.~   "
22061|NCT02768415|"~     Apatinib is an orally administered second-generation blocker of the phosphorylation of the~     tyrosine residues within the intracellular domain of VEGF receptor 2 (VEGFR2). A~     prospective, open label, phase II multicenter trial of apatinib in heavily pretreated~     patients with metastatic triple-negative breast cancer demonstrated that the daily dose of~     apatinib 500 mg/day is active in pretreated metastatic TNBC with encouraging rates of~     disease stabilization and PFS.~      Vinorelbine is a highly active drug in the treatment of MBC, both as a single agent or in~     combination regimens, and is well tolerated, with a low incidence of severe toxicity.~     Clinical trials demonstrated oral NVB provided comparable effectiveness to iv NVB. and oral~     availability allows using different schedules.~      The NCCN guideline introduces that combination chemotherapy is one of the standard treatment~     options in metastatic breast cancer, especially in patients with visceral metastases and/or~     need of rapid symptom or disease control.~      Theoretically, anti-angiogenesis regimen combined with chemotherapy may present increasing~     therapeutic effect. Related researches are urgently needed to find optimal combined therapy.~   "
22062|NCT02768402|"~     The purpose of this study is to assess the safety and performance of the Caisson~     Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of~     severe symptomatic MitralValve Regurgitation (MR).~   "
22063|NCT02768389|"~     Patients may participate in this research study if they have glioblastoma. (a brain tumor)~     that has come back after being treated. Standard treatment for this cancer is a chemotherapy~     drug called bevacizumab. This research study involves bevacizumab in combination with a~     special diet called the Modified Atkins Diet (MAD).~      The purpose of this study is to research if patients can stay on the MAD when it is added to~     the standard bevacizumab treatment.~   "
22064|NCT02768376|"~     In this study, the investigators will study spinal anesthesia for laparoscopic~     cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a~     primary variable, intraoperative complications, postoperative analgesic requirements,~     postoperative nausea and vomiting, patient hospital stay (secondary variables).~   "
22065|NCT02768363|"~     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in~     patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves~     the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer~     vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's~     immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in~     previous trials in patients with prostate cancer and other tumor types. Biochemical,~     pathologic and immune responses have been demonstrated in newly diagnosed and recurrent~     prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical~     outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak®~     or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance~     evaluations.~   "
22066|NCT02768350|"~     The purpose of this study include (1) To investigate the efficacy of ventilator~     hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who~     intubated and mechanical ventilation in the intensive care unit, (2) To investigate the~     effectiveness of ventilator hyperinflation technique to improve airway clearance on patients~     with critical trauma in the intensive care unit, and (3) To explore the acute responses of~     ventilatory functions to ventilator hyperinflation technique on patients with critical~     trauma who intubated and mechanical ventilation in the intensive care unit.~   "
22067|NCT02768337|"~     Proof of principle phase 1b / randomised phase 2 study of afatinib penetration into cerebral~     metastases for patients undergoing neurosurgical resection, both with and without prior~     low-dose, targeted radiotherapy.~   "
22068|NCT02768324|"~     Sepsis is a life-threatening condition that arises when the body's response to infection~     injures its own tissues and organs. Common signs and symptoms include fever, increased heart~     rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea~     often result in a bad prognosis. Gut microbiota consists of a complex community of~     microorganisms that live in the digestive tracts of animals. The gut microbiota comprises~     the largest and most diverse reservoir of mutualistic microorganisms associated with~     animals. The aims of this study is to determin the effect of gut microbiota on the prognosis~     of Sepsis, by using 16s pyrosequencing, comparing the blood culture result.~   "
22069|NCT02768311|"~     Today, dentists tend to use rotary systems. Despite the increasing diversity of these~     systems as well as a few studies on the prevalence of pain after root canal treatment by~     rotary systems, And in particular, comparing the amount of pain after treatment, between~     systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the~     effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of~     pain after endodontic treatments.~   "
22070|NCT02768298|"~     The purpose of the study is to determine the effect of LCZ696 vs. Enalapril on improvement~     of excercise capacity in patients with chronic heart failure with reduced ejection fraction~   "
22071|NCT02768285|"~     The purpose of this study is to determine whether maintaining an apical patency causes~     postoperative pain in teeth with necrotic pulp and apical periodontitis.~   "
22072|NCT02768272|"~     The investigators have design a randomized double blind clinical trial to know the incidence~     of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical~     dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses~     versus patient controlled epidural analgesia. The role of the epidural technique (epidural~     versus combined spinal-epidural) in the incidence of BP will be also evaluated.~   "
22073|NCT02768259|"~     -  Measuring the incidence and prevalence of PAH in Egyptian patients with different types~          of MCD~        -  Determination of survival & the risk factors of mortality.~   "
22074|NCT02768246|"~     Ventilation of a bearded patient with the commonly used face mask has low efficiency because~     of difficulties to achieve a tight seal around the mouth and nose.~      The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor~     (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating~     the need for a face mask.~   "
22075|NCT02768233|"~     The aim of this study is to evaluate the influence of personality profiles in patients with~     MOH and to evaluate the effect of a custom-made educational programme as an add-on to~     standard treatment as compared to standard treatment alone in MOH patients using a~     randomized controlled trial (RCT) design.~   "
22077|NCT02768207|"~     This is a single arm, multicenter, open label, and non-randomized clinical study on adult~     participants with unresectable or metastatic melanoma. The study will be conducted in two~     phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis~     triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical~     outcome for the participants treated with vemurafenib plus cobimetinib. The length of the~     study will be approximately 36 months.~   "
22078|NCT02768194|"~     This will be a single centre, single blind, randomized, three treatment, three period~     crossover design, modified, in situ, study in healthy participants. In this in situ model~     the tubule occlusion properties of dentifrices will be evaluated by comparing an~     experimental dentifrice formulation to a regular fluoride dentifrice and a negative control~     (mineral water) over a ten day period.~   "
22079|NCT02768181|"~     Background:~        1. Burden: The prevalence of stunting among the under-five children in Bangladesh was >55%~          in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with~          existing interventions, and till today Bangladesh remains among the countries with the~          highest stunting prevalence.~        2. Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al~          (2013) modelled the effect of 10 direct interventions on lives saved and economic costs~          in 34 countries which contains 90% of the children with stunted growth. Their findings~          suggested that at 90% coverage, these interventions could cut down under-5 year~          mortality by 15% and avert one-fifth of stunting. The total additional annual cost was~          estimated at $9.6 billion. There is a dearth of primary research, however, to determine~          a feasible, effective bundle of interventions for developing countries.~        3. Relevance: This study will review and test different sets of nutrition-specific~          intervention bundles in a cohort of pregnant women and the subsequent impact on the~          length-for-age Z score (LAZ) of their offspring from that pregnancy.~      Hypothesis: Five selected nutrition-specific interventions implemented during early~     pregnancy and during first two years of child's life in different bundles will cause a shift~     of 0.4 in mean HAZ score among children at 24 months of age compared to those in comparison~     arm.~      Methods: The investigators propose a community-based randomized trial (CRCT) to evaluate the~     effectiveness of different combinations of the five selected nutrition-specific~     interventions and identify the best combination for improving childhood HAZ. Selected~     interventions include prenatal nutrition supplementation; intensive counselling on prenatal~     nutrition, exclusive breastfeeding and timely complementary feeding; and complementary food~     supplementation during 6-23 months. The proposed study area is Habiganj district, Sylhet~     division. 125 clusters (each ~2000 population or ~450 households) will be selected from 12~     homogenous unions in 2 adjacent sub-districts. The clusters will then be randomly assigned~     to any one of the 5 study arms. Data would be collected at baseline and followed up,~     including on nutritional intake and anthropometric measurements of mothers and offspring.~     Primary outcome measure/variable would be mean HAZ of offspring at 24 months. Secondary~     outcome variables include nutritional intake during pregnancy, maternal weight gain,~     exclusive breast feeding up-to 6 months, and birth weight.~      Implications: The investigators expect that the results will serve to inform and shape~     future health policy decisions related to promotion of maternal and child health.~   "
22080|NCT02768168|"~     The purpose of this study is to investigate the efficacy of dezocine pretreatment on~     dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).~   "
22081|NCT02768155|"~     A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of~     subjects with osteoarthritic (OA) knee pain~   "
22082|NCT02768142|"~     Throughout the history, the neonate was dependent on maternal touch and care for survival.~     In modern obstetrics, with hospital care the neonates are seldom separated from their~     mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to~     increase milk production, lactation and improve maternal and neonatal outcome.~      Oxytocin is the primary hormone responsible for uterine contraction and prevention of~     postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.~      The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was~     found to decrease postpartum milk production, postpones early lactation and decreases~     exclusive breastfeeding.~      During the typical CD, the neonate is usually presented for a short while to the mother and~     breastfeeding is usually delayed at least a number of hours until after the surgery and the~     recovery period.~      Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to~     start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin~     secretion increases with ESTS and during breastfeeding.~      The aim of this study is to examine blood loss that occurs after Natural CD compared to~     standard CD without an ESTS contact.~   "
22083|NCT02768129|"~     The goal of this study is to investigate the role of central neural pathways in mediating~     chronic pain. The aim of the study is to test the effect of stimulating brain regions that~     are part of a network underlying central pain processing using a non-invasive brain~     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have~     used tDCS to target both sensory related cortical areas and those important for higher-order~     representations of pain. This study will target brain regions important for the behavioral~     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain~     regions can modulate not only the affective component of pain, but ultimately also improve~     functioning and quality of life. This hypothesis will be tested by treating study~     participants eighteen and older with chronic low back pain (CLBP) of greater than six months~     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion~     criteria.~   "
22084|NCT02768116|"~     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active~     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary~     Bifurcation Lesions.~   "
22085|NCT02768103|"~     The number of people in the United States who have survived SCI is estimated to be~     approximately 273,000 persons. Around 50% of the injuries are to the cervical spine~     resulting in tetraplegia. An important rehabilitation goal in this population is recovery of~     upper limb function, which could decrease medical costs and improve their quality of life.~     Re-establishing active grasp and pinch strength to the hand can be accomplished by surgeries~     that transfer the tendon of a strong muscle to restore strength to a paralyzed muscle, but~     the outcomes of the surgeries are variable. The investigators have demonstrated in an~     ongoing study, the functional gains after surgery can be improved with a focused therapy~     program to retrain the transferred muscle. The propose of this study is to examine the~     cortical mechanisms that drive successful muscle re-education after surgery. Understanding~     the neural (brain) activity associated with functional performance can help to predict who~     will respond to therapy and will guide evidence-based rehabilitation programs to improve~     upper limb function in tetraplegia.~   "
22098|NCT02767934|"~     This phase II clinical trial studies how well pembrolizumab works in treating small amounts~     of cancer cells that remain after attempts to remove the cancer has been made in patients~     with acute lymphoblastic leukemia. Monoclonal antibodies, such as pembrolizumab, may~     strengthen the immune system and help it to target remaining cancer cells.~   "
22086|NCT02768090|"~     This study will investigate a new diagnostic technology in order to expand current~     understanding of inflammatory and neoplastic cutaneous disease processes such as eczema,~     psoriasis, granuloma annulare, cutaneous lymphoma, squamous cell carcinoma, basal cell~     carcinoma and melanoma. Protein fragments found in sweat will be collected using a~     diagnostic skin patch and analyzed with mass spectrometry. The goal of this study is to~     identify specific protein fragment biomarkers that may further current understanding of~     cutaneous diseases. The protein expression patterns derived from sweat will be compared to~     conventional histopathologic, immunohistochemical, flow cytometry, in-situ hybridization,~     polymerase chain reaction, and mass spectrometry analyses of cutaneous biopsy specimens. The~     insight gained from this research will be used to promote advances in disease prevention and~     early diagnosis, identify prognostic indicators and new therapeutic targets.~   "
22087|NCT02768077|"~     This clinical study is a double-blind, randomized, placebo-controlled trial to investigate~     the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,~     symptoms which have a significant impact on the quality of life of these patients.~   "
22088|NCT02768064|"~     During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted.~     The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).~      All TAVI patients require a temporary pacemaker(PMK), which is usually performed by~     insertion of a standard temporary electrode through the femoral vein. The temporary PMK is~     associated with a small but significant rate of complications.~      The PMK is usually removed immediately at the end of the TAVI procedure, only when using the~     Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications,~     and thus the PMK is later removed in these cases.~      PMK Complications seen include:~        -  Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in~          some cases with Tamponade~        -  Infection~        -  Electrode dislocation causing In-effective pacing (and/or sensing)~        -  Prolonged bed rest~        -  Prolonged hospitalization~        -  Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of~          patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was~          associated with the temporary PMK.~   "
22089|NCT02768051|"~     Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time~     in humans, in subjects undergoing ablation for the treatment of atrial flutter.~      Prospective, single-center, non-randomized, open label, single arm study. Ten consented~     subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will~     undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation~     procedure) and post procedure follow up. All subjects will have a follow up visit within 24~     hours post procedure.~   "
22090|NCT02768038|"~     The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic~     inflammatory bowel diseases (IBD)~   "
22091|NCT02768025|"~     Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on~     Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased.~      According the trend, development and evaluation of the medical guideline, Induced~     participation of medical personnel and available in Korean medical clinic, is needed.~     Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine~     (T&CM) tobacco control program Methods: Recruited subjects were divided into control and~     test groups. They treated two times a week during the first three weeks and once a week~     during the last week.~      Program participation rates and drop rates, satisfaction, amount of smoking before and after~     programs~      , smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO~     amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D)~     are measured.~   "
22092|NCT02768012|"~     Antidepressant-induced sexual dysfunction (AISD) affects the majority of women taking~     antidepressants and reduces medication compliance: however there is a paucity of~     evidence-based strategies for the management of this condition. Mindfulness-based cognitive~     therapy (MBCT) has been shown to be effective in the treatment of non-antidepressant-induced~     sexual dysfunction and may be beneficial in the treatment of AISD. The investigators propose~     a randomized, controlled, proof-of-principle trial to establish preliminary evidence of~     efficacy of MBCT in AISD and to inform the design of a larger trial to evaluate its~     effectiveness~   "
22093|NCT02767999|"~     Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients~   "
22094|NCT02767986|"~     Background:~      Culture can affect the way a person thinks about illness. This can affect how they seek help~     for illness. It can also affect how they choose a treatment and follow it. This can lead to~     health disparities among certain groups of people. Breast and colon cancers are the most~     common cancers for Latinos. Even though they get these cancers at lower rates than other~     population groups, Latinos are more likely to be diagnosed with these cancers at advanced~     stages. Researchers want to study what Latina women immigrants believe causes breast and~     colon cancer and other factors they think play a role in disease. This understanding could~     lead to better interactions between Latinos and their doctors.~      Objective:~      To learn more about what Latina immigrants believe causes breast and colon cancer and other~     factors they think play a role in disease.~      Eligibility:~      Women ages 18 and older who:~      Were born in Latin America~      Speak Spanish~      Have never had breast, ovarian, or colon cancer~      Design:~      Participants will be interviewed in person or over the phone. This will take up to an hour.~     The interview will be recorded. Participants will answer questions about:~      Their family s cancer history~      What they think causes breast and colon cancer~      What they think plays a role in disease~   "
22095|NCT02767973|"~     Purpose: This screening protocol is designed to assess PMN (neutrophil) responsiveness to~     wood smoke particles (WSP) and the effect of the GSTM1 null genotype on this response. The~     researches will identify persons responsive and resistant to the inflammatory effect of WSP.~     It is anticipated that the GSTM1 genotype will be a risk factor for increased response to~     WSP.~   "
22096|NCT02767960|"~     This study valuates the serum Tenascin-C concentration in patients with acute coronary~     syndrome.~   "
22097|NCT02767947|"~     A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study~   "
22113|NCT02767739|"~     Community intervention trial, randomized, to promote regular PA and social and cultural~     support activities for 9 months in older-adult primary care users and assess their effects~     on cardiovascular risk factors and health-related quality of life.~   "
22099|NCT02767921|"~     This pilot clinical trial studies the side effects of recombinant EphB4-HSA fusion protein~     before surgery in treating patients with transitional cell carcinoma of the bladder,~     prostate cancer, or kidney cancer. Recombinant EphB4-HSA fusion protein may block an enzyme~     needed for tumor cells to multiply and may also prevent the growth of new blood vessels that~     bring nutrients to the tumor. Giving recombinant EphB4-HSA fusion protein before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
22100|NCT02767908|"~     The present study is proposed to build on the investigators demonstration of the~     effectiveness of default delivery of smoking interventions in hospital inpatients by testing~     a multi-component intervention to prevent relapse to smoking after hospital discharge. The~     proposed intervention is designed to integrate easily with existing services, and hence be~     widely implemented if shown to be effective~   "
22101|NCT02767895|"~     Patients undergoing elective revascularization of their peripheral artery disease will be~     randomized to a prehabilitation program or usual care prior to their scheduled procedure.~   "
22102|NCT02767882|"~     The primary aims of total knee replacement are improvement in functional activities and~     reduce pain due to degenerated knee joints. However, there are around 20-30% of patients~     would develop significant pain problem despite uncomplicated total knee replacement. It~     accounts for major post-operative problems and burdens.~      Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is~     well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative~     single dose of systemic dexamethasone have shown to be useful for reduction in pain and~     cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that~     dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after~     surgical procedures. However, this dose recommendation is not surgery specific. It is~     essential to have more RCTs evaluating the optimal dose of steroid for pain management after~     hip and knee surgery.~   "
22103|NCT02767869|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin~     secretion.~      The investigators hypothesis was that the the administration of resveratrol modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
22104|NCT02767856|"~     This study is designed to answer the question: What if the Intermittent Occlusion~     (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment~     only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12~     weeks?~      Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled~     and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or~     2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.~   "
22105|NCT02767843|"~     This pilot study will examine the efficacy and safety of continuous negative external~     pressure (cNEP) for the treatment of chronic snoring in people without obstructive sleep~     apnea.~   "
22106|NCT02767830|"~     A 12 month long program focused on making good food choices and exercise directed at 8-12~     year olds and their caregivers. The program will consist of monthly educational meetings~     each teaching a new nutritional and exercise concept. Children will be given weekly exercise~     schedules and their adherence to the program will be assessed. The study will culminate with~     an annual children's race in May.~   "
22107|NCT02767817|"~     The purpose of this study is to assess the safety and efficacy of injectable collagen~     scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain~     injury.~   "
22108|NCT02767804|"~     The primary purpose of this study is to evaluate the efficacy and safety of X-396~     (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that~     have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.~   "
22109|NCT02767791|"~     The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent~     years and became less frequent. CINV include early (occurring within 24 hours of~     chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea~     and vomiting.~      Preventive treatment, such as Glucocorticoids, 5-HT3 receptor antagonists and NK1 receptor~     antagonists, are administered according to the classification in 4 grades of expected CINV~        -  Very low: <10% occurrence of CINV;~        -  Low: 10 to 30% occurrence of CINV;~        -  Average: 30 to 90% occurrence of CINV;~        -  High: > 90% occurrence of CINV. These treatments have been the subject of~          recommendations. Despite these available treatments, some patients still complain of~          vomiting, or more frequently nausea and loss of appetite.~      Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as~     complementary treatment, mainly in the acute phase and to a lesser extent in the delayed~     phase. The most common points are Pericardium 6 (wrist) treated with conventional~     acupuncture needles, electro-acupuncture or acupressure.~      Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and~     postoperative nausea, but, to our knowledge, there are no studies published on the effect of~     auriculotherapy on CINV.~      These complementary treatments have virtually no side effects. In our institution, a simple~     treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular~     point treated) is regularly use in patients who present CINV despite preventive treatment~     and most of them are relieved.~      The investigators propose a clinical trial in this population to assess symptoms improvement~     in patients presenting CINV after their first administration of chemotherapy despite adapted~     preventive treatment. Experimental treatment with semi-permanent needles takes place during~     administration of the second session of chemotherapy. CINV are evaluated through the MAT~     score (Multinational Association of Supportive Care in Cancer Antiemesis Tool.~     Http://www.mascc.org/) that measures the frequency and intensity of nausea and vomiting in~     the 24 hours following the session and during the 4 days after administration Chemotherapy.~   "
22110|NCT02767778|"~     The main purpose of this multicentric, prospective, randomized, placebo-controlled,~     double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe~     tool to promote recovery in acute ischemic stroke patients.~      124 patients with acute ischemic stroke will be recruited and randomly assigned to real or~     sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min~     daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.~      The primary outcome will consist of reduction of the expected infarct growth at MR measured~     in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness,~     safety and tolerability of pulsed ELF-MF in acute ischemic stroke.~   "
22111|NCT02767765|"~     This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular~     (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and~     histologically or cytologically confirmed cancer.~   "
22112|NCT02767752|"~     This is a single center, randomized, double-blind, placebo-controlled phase II trial that~     will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as~     adjuvant treatment for 6 months in patients with surgically resected pancreatic~     adenocarcinoma.~   "
22114|NCT02767726|"~     Cervix cancer is a major global health concern. A way to screen and immediately treat~     precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized~     difference imaging and conventional imaging are used to identify suspicious lesions. We aim~     to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will~     have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both~     to colposcopy impression versus MobileOCT.~   "
22115|NCT02767713|"~     Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac~     surgery. This prospective study was conducted to investigate the mechanisms of development~     of POCD following cardiac surgery taking into account surgical technique (with use or no use~     of extracorporeal circulation). The investigators focused on the role of inflammatory and~     stress response to surgical procedure as potential factors involved in the pathogenesis of~     cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or~     off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and~     occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was~     evaluated following cortisol levels and its daily variations. The degree of cognitive~     dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the~     levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on~     the development of POCD was compared with control group that received normal saline.~   "
22116|NCT02767700|"~     The tumor tissue of patients with pancreatic cancer will be submitted to next-generation~     sequencing (NGS) and these data will be evaluated with an oncology treatment decision~     support (TDS) software tool that is a medicinal product class 1 (CE-marked). This software~     will make evidence-based suggestions for drugs likely to be effective, ineffective, or toxic~     (FDA approved biomarkers). For patients fit for second-line therapy, the resulting~     recommendations will be judged by the tumor board.~   "
22117|NCT02767687|"~     This study evaluates whether noninvasive ventilation with continuous positive airway~     pressure affects tissue perfusion in patients after cardiac surgery.~   "
22118|NCT02767674|"~     The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP~     as first-line treatment of elderly patients with Diffuse large B cell lymphoma~   "
22119|NCT02767661|"~     The study is designed to compare the clinical benefit following treatment with aromatase~     inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in~     women with hormone receptor-positive, Her2-negative advanced breast cancer who have not~     received prior systemic anti-cancer therapies for their advanced/metastatic disease.~   "
22120|NCT02767648|"~     The goal of the study is to characterize the epidemiologic data of the neonatal and infant~     cholestasis.~   "
22121|NCT02767635|"~     The aim of the study is to compare two different injection sites of low dose botulinum toxin~     type A with steroid in treating lateral epicondylalgia.~   "
22122|NCT02767622|"~     This study included 20 patients listed for liver transplantation in addition to 20 age- and~     sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations~     were performed for both patients and controls before and 6 months after liver~     transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B,~     Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver~     transplantation.~   "
22123|NCT02767609|"~     This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because~     this technique for measuring CBF is new, there is little information on what the normal~     values for different regions of the brain should be. Information from the study will be used~     to establish normative CBF values for the brain, improving the reliable use of this~     technique for the diagnosis of brain injury or disease.~   "
22124|NCT02767596|"~     The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide~     to achieve glycemic control in type 2 diabetes patients, in patients with failure of long~     acting GLP-1 analog.~      Patients who fail to achieve significant improvement in diabetes control on basal insulin~     and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks.~     The primary outcomes will be changes in HBA1C and weight.~   "
22125|NCT02767583|"~     Background / rational:~      Obesity is associated with significant comorbidities including type 2 diabetes (insulin~     resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia,~     cancer, hepatobiliary diseases, orthopedic complications and psychosocial impact 1 .~      Peripheral neuropathy is a known complication in the type I and II diabetes and glucose~     intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are~     associated with cardiovascular risk high vascular, presence of metabolic syndrome~     constitutes in itself a well demonstrated vascular risk factor. Its definition requires the~     presence of three elements from the following 5: abdominal obesity (high waist~     circumference), high blood pressure, high fasting blood sugar, high triglycerides and / low~     HDL-cholesterol 3.~      This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated~     diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber~     neuropathy 4. The cardinal sign of NAION is the presence of neuropathic pain but~     abnormalities in physical examination are often absent and conventional electromyography is~     faulted to make the diagnosis. These small fibers are also constituent of the autonomic~     nervous system and causes damage autonomic dysfunction that can manifest the cardiovascular~     system (hypotension, cardiac conduction disorders), digestive, sweat, sphincter. neuropathy~     of the diagnosis of small fibers is suggested clinically by the presence of neuropathic pain~     often contrasting with a normal clinical examination. The confirmation is based on~     electrophysiology with various techniques and quantification of intra-epidermal nerve~     fibers.~      Main objective / secondary:~      Primary objective :~      To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese~     patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C~     autonomic~      Secondary objectives:~        -  Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during~          follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6,~          9, 12.~        -  Correlation of results obtained Sudoscan® quantitative sensory testing (QST)~          Thermotest® evaluating small sensory fibers Aδ, among non-operated non-diabetic obese~          patients and in the postoperative follow-up (months) M1, 3, 6, 9, 12.~        -  Characterization of electromyographic parameters (motor and sensory conduction) in~          patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of~          sensitivity to pain increased Thermotest®.~        -  Correlation between the presence of a small fiber neuropathy in non-diabetic obese~          subjects with clinical and biological parameters collected.~      Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5~     patients included / week of 15 patients collected in central obesity / week) including 12~     months of inclusion.~      Number of topics to include: 100 over a period of one year to adjust to the rhythm of the~     inclusions.~      As mentioned, patients will be a measure of impedance of the skin to products chlorine ions~     by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for~     the detection of violations neuropathic (cf. references and CE certificate attached to the~     dossier).~      The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see~     references and CE certificate attached to the dossier).~      Our center has gained experience of these techniques for the detection of peripheral~     neuropathy in several patient populations (diabetes and cancer in particular); manipulators~     (doctors and technicians) are trained in these techniques.~   "
22126|NCT02767570|"~     Nearly one out of every two Americans will develop knee osteoarthritis by age 85. Over 20~     million Americans, including nearly three million Veterans, currently have painful knee~     arthritis that limits their daily activity or recreation. The vast majority of those~     individuals will be prescribed anti-inflammatory drugs that provide some pain relief but do~     not slow the progression of the disease. Often people with knee arthritis are told they must~     live with the pain until they become appropriate candidates for knee replacement surgery,~     but that can require tolerating the pain and limiting function for many years. Because of~     other health issues, some individuals are never acceptable surgery candidates. What is~     desperately needed are better conservative approaches for treating these patients. Two such~     approaches will be tested and compared in this study.~   "
22127|NCT02767557|"~     This is a single center, 2-arms prospective randomized phase II trial which evaluates~     whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than~     gemcitabine/nab-paclitaxel.~   "
22128|NCT02767544|"~     In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine (~     vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative~     pain and need of oxycodone.~   "
22129|NCT02767531|"~     Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia~     marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is~     caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a~     challenge to treat, as the only effective therapy available is an extremely low fat diet.~     This diet is exceedingly difficult to follow, and despite adherence, many patients still~     have chylomicronemia and develop acute pancreatitis.~      Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor,~     Orlistat, in reducing serum triglyceride levels in patients with T1HLP.~   "
22130|NCT02767518|"~     This is a 2-group study comparing the effect of a prehabilitation program to usual care on~     quality of life and clinical outcomes in patients undergoing elective repair of their~     thoracic aorta.~   "
22131|NCT02767505|"~     This is nationwide registry-based randomized clinical multicenter trial in which patients~     will be randomized to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary~     endpoint are weight control over 5 years and the amount of severe adverse events.~     Additionally the investigators have predefined a number of secondary endpoints, and the~     trial has a sufficient number of patients to allow comparisons across subgroups.~   "
22132|NCT02767492|"~     This study will include patients who are diagnosed with knee OA and are recommended for a~     knee injection. Study subjects will be randomized to receive either the standard of care~     knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be~     asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months~     post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be~     followed for 1 year post-injection to include range of motion measurements and~     patient-reported pain/functional outcome measurements. X-rays will also be taken at the~     1-year post-injection appointment.~   "
22133|NCT02767479|"~     Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and~     CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication~     rates are compared. Patients who have ever failed in eradication by CAM-based regimen are~     treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg~     bid, AMPC 750 mg bid and MNZ 250 mg bid.~   "
22134|NCT02767466|"~     Using a single blind within-subject design, 16 patients with neurological disorders were~     randomly exposed to two different treatments: physical therapy and robotic assisted gait~     training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was~     used to assess the effects on the treatment on distinct affective states. The subscales of~     the MSS were tested for pre-post changes and different effects between treatments with~     non-parametric tests.~   "
22135|NCT02767453|"~     The purpose of this study is to determine the limited effectiveness of drains during Total~     Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease~     infection rates, swelling,and the number of dressing changes required during a hospital~     stay. The use of drains has been heavily investigated in the hip and knee replacement~     literature, but there have been no investigations regarding their use in shoulder~     replacements, despite frequent use.~      Clinical benefit has not been consistently documented regarding drain usage in hip and knee~     arthroplasty and the investigators hypothesize that they are of limited utility in total~     shoulder arthroplasty as well. The investigators will perform a prospective investigation of~     total shoulder arthroplasty patients- dividing them into two groups- half will receive a~     drain at the time of surgery and the other half will not be receiving a drain.~   "
22136|NCT02767440|"~     Current models of outpatient childhood obesity treatment focus on the child's health habits,~     with limited efficacy. In part, this may be because childhood obesity is highly sensitive to~     parental lifestyle habits, who are often not a direct target of child obesity interventions.~     This study aims to target weight loss among overweight parents of 2-16 year old children~     with obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child~     body mass index reduction. The intervention,  Families on Track is a digital health~     intervention platform using the Interactive Obesity Treatment Approach (iOTA).~   "
22137|NCT02767427|"~     The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine~     wipes provide no added benefit to decreasing microbial activity or preventing surgical site~     infections.~      Patients will be randomized to the chlorhexidine or no additional intervention groups.~     Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no~     additional intervention. Those randomized into the chlorhexidine gluconate home-application~     group will be asked to shower the night before surgery, and to use a standardized~     pre-packaged chlorhexidine gluconate wipe (that the patients would receive at their~     pre-surgical consultation) on their surgical site after thoroughly drying those areas. The~     patients will be asked to use a second wipe in each area the morning of surgery. The~     surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each~     of these two groups will be randomized separately. All patients will undergo a standardized~     preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol~     solution. Then, the surgical site (either the anterior portion of the neck or the posterior~     area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with~     chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon~     preference. Cutaneous samples will be taken from the surgical site of each patient at each~     time point.~   "
22138|NCT02767414|"~     The primary purpose of this study is to validate the sensitivity and specificity of the~     Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold~     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).~      The secondary aims are to:~      Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in~     detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase~     Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu~     Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the~     convenience, comfort and ease of use of the Respirio Flu Test.~   "
22139|NCT02767401|"~     The purpose of this study is to investigate the effect of percutaneous coronary intervention~     (PCI) on myocardial viability in coronary artery disease patients with single coronary total~     occlusion (CTO) lesions.~   "
22156|NCT02767180|"~     An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical~     care will be tested in a study of 650 patients recruited six months to three years after~     discharge from the ICU, and 150 controls who have not been critically ill, matched for age~     and sex. The questionnaire is sent by mail after an invitation letter followed by a phone~     call and returned in a pre-stamped envelope. It is then scanned and data imported digitally.~     Medical data from the ICU-stay can be added. Further analyses after comparison with the~     control population and item reduction will follow.~   "
22157|NCT02767167|"~     Iodine is an essential trace element necessary for the synthesis of thyroid hormones which~     are critical for human growth and development throughout the lifecycle. Iodine is~     particularly important during pregnancy and infancy for brain and neurological development.~     Severe iodine deficiency during pregnancy can cause severe mental impairment and stillbirth~     while mild-to-moderate deficiency has been associated with impaired infant development. As~     such, pregnant women and women of child-bearing age are particularly vulnerable to the~     effects of iodine deficiency.~      Globally, 241 million (30%) school aged children are iodine deficient. Historically, the UK~     and Ireland were believed to be iodine sufficient but concern has been expressed in the last~     decade regarding the iodine status of the UK and Irish populations. A study of Irish women~     in 2004 reported 55% of pregnant women in their sample population to be moderately iodine~     deficient and 53% of non-pregnant women to be moderately iodine deficient. A study of UK~     schoolgirls found that 51% were mildly iodine deficient and 16% were moderately deficient.~     Importantly, the prevalence of iodine deficiency was highest in Northern Ireland where 85%~     of those sampled were iodine deficient.~      Iodine is known to interact with selenium in the conversion of the thyroid hormone thyroxine~     (T4) to the metabolically active triiodothyonine (T3) hormone. Selenium is also important~     for immune, cardiovascular and cognitive function. Selenium status has been reported to be~     moderately low using pooled English data on blood selenium concentrations from 1984 to 1992.~     In addition, the latest National Diet and Nutrition Survey reports that selenium intakes are~     below recommendations for several population groups including women of childbearing age~     where mean selenium intakes are 76% of the recommended 60µg/day. This national survey also~     reported that 49% of women aged 19-64 years failed to meet the lower reference nutrient~     intake of 40µg/day.~      Milk and dairy products are the major source of iodine for the UK population and are also a~     source of selenium. The contribution of milk and dairy products to iodine and selenium~     intakes is greatest in adult females (35% and 6% respectively). Observational evidence has~     repeatedly reported milk consumption to be positively correlated with iodine status and~     iodine intakes. Research in Iceland and New Zealand has reported that milk consumption is~     not associated with selenium status; however it is unknown if this is true for the UK~     population.~      To date, no randomised controlled trial has examined the effect of milk consumption on~     either iodine or selenium status. The possibility of increasing iodine and selenium intake~     by increasing milk consumption, a widely available and consumed foodstuff, in a population~     group vulnerable to micronutrient deficiency should be investigated. This would add valuable~     data to the knowledge base for iodine, where there is ongoing debate over the most~     appropriate means of increasing iodine intake amongst women of childbearing age in the UK~     where salt iodisation, the key strategy in preventing deficiency, is not implemented.~      The aim of this study is to investigate the impact of cow's milk consumption on the~     biological status of iodine and selenium among women of child-bearing age.~      The study will be a 12 week randomised-controlled human intervention study. Participants~     will be randomised to consume additional semi-skimmed milk in the Following amounts, control~     group (0mls/day), intervention group (430mls/day or 3l per week).~   "
22158|NCT02767154|"~     This study will compare two priming solutions for extracorporeal circulation, one based on~     Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure~     during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ~     functions.~   "
22140|NCT02767388|"~     Broadly speaking, the goal of this study is to better understand the influence of~     chemotherapy treatment on the cognitive and neural mechanisms underlying human behavior.~     Extant literature lacks diversity in studied cancer populations and treatment protocols, and~     provides limited understanding of the cognitive abilities that are impaired by chemotherapy.~     To overcome these limitations, this study will employ a sophisticated battery of tests on an~     understudied cancer population. Eligible participants will either be patients diagnosed with~     Myelodysplasic Syndrome (MDS) or demographically matched healthy control patients.~      After MDS diagnosis and treatment protocols have been established, patients will be inducted~     into the longitudinal study comprised of three visits: 1) after diagnosis but prior to~     chemotherapy treatment (baseline), 2) after one treatment cycle (one month post-baseline),~     and 3) after three treatment cycles (three months post-baseline). Patients will undergo a~     test battery designed to measure specific behavioral and neural mechanisms of attention;~     tests will either be computer-based cognitive tasks or simulated driving tests that immerse~     patients into virtual driving scenarios. During each test, EEG will be concurrently measured~     through non-invasive scalp electrophysiology recordings; EEG recordings will reveal~     underlying neural mechanisms affected by chemotherapy. Additionally, neuropsychological~     tests of vision, attention, and memory will be administered, as well as questionnaires to~     evaluate health, mobility, and life space. Finally, blood samples will be collected to~     examine levels of circulating inflammation-specific proteins typically present in cancer~     patients. This study will allow us to better understand the mechanisms through which~     chemotherapy influences cognitive performance. Results from this study will influence the~     administration of chemotherapy treatments so that patients can continue to receive the~     highest medical care while maintaining optimal cognitive abilities and quality of life.~   "
22141|NCT02767375|"~     To study if the addition of HAIC following complete removal of early stage liver cancer of~     HCC will prevent or delay the recurrence of the disease. Half of the participant will~     receive two cycles of the HAIC after the hepatectomy, while the other half will return to~     the baseline surveillance schedule.~   "
22142|NCT02767362|"~     This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese~     women who are to undergo surgical staging for endometrial cancer.~   "
22143|NCT02767349|"~     An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical~     adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will~     assess the safety of administering multiple doses of MNK-155 in this population.~   "
22144|NCT02767336|"~     Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions~     for Use and Marketing Claims Evaluation.~   "
22145|NCT02767323|"~     Cognitive decline and dementia have become important public health issues in our time as~     medical science has increased lifespan and our society becomes progressively older. A great~     deal of the cognitive decline due to aging can be explained by decline in working memory~     (WM), a mental function central to cognition in which aging deficits appear almost~     universally. Attempts to use WM training to increase WM ability in older adults has had some~     success, but the transfer of performance enhancements caused by this training to other~     cognitive skills is controversial. Another intervention that shows much promise is~     noninvasive stimulation of cerebral cortex using transcranial magnetic stimulation (TMS),~     which has been shown to increase performance in many cognitive tasks. Here, the investigator~     proposes to use fMRI-guided TMS enhancement paradigm to stimulate dorsolateral prefrontal~     cortex (DLPFC), a region involved not only in the maintenance of items in WM, but also in~     their manipulation, in order to create WM performance enhancements that will be long lasting~     and that will transfer to other cognitive tasks as well. This will be achieved through three~     studies. In the first the investigator will stimulate both old and young healthy adults~     while they perform different WM tasks that will increasingly engage DLPFC in order to~     demonstrate enhancement of WM performance that is greater in the older adults. In the second~     and third studies, older adults will receive active or sham TMS over two weeks of daily~     sessions while they perform the WM tasks. In the second study, the investigator hopes to~     demonstrate that the cumulative effect of multiple TMS sessions, in tandem with the~     synergistic effects of simultaneous TMS + WM training, create WM performance enhancements~     greater than those found with WM training alone, whose effects are long-lasting, continuing~     a month following the course of TMS sessions. In the third, the investigator will~     investigate whether the WM enhancements generated by the two weeks of TMS sessions will~     generalize to other cognitive tasks. Success of these studies will provide proof in~     principle for long-lasting, transferable effects of TMS in remediating WM and more general~     cognitive deficits due to aging, and point to a possible non-invasive brain stimulation~     therapy for cognitive decline in healthy aging and in dementia.~   "
22146|NCT02767310|"~     The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20~     mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.~   "
22147|NCT02767297|"~     To determine the relative bioavailability of the capsule (reference) and tablet (test)~     formulations of FDL169 in healthy adult males and females, and to evaluate the~     pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males~     and females, and subjects with cystic fibrosis (CF).~   "
22148|NCT02767284|"~     This study evaluates the relative performance of different methods to measure the human~     spectral contrast sensitivity function (CSF).~   "
22149|NCT02767271|"~     The objective of this study is to evaluate the pharmacokinetics of Luliconazole Cream 1% in~     subjects with moderate to severe tinea pedis or tinea cruris.~   "
22150|NCT02767258|"~     Clinical trial for prevention, randomized controlled, parallel, double-blind, with three~     arms, which purpose is verify the nursing interventions (artificial tear gel and liquid~     artificial tears)effects to prevent dry eye in adult patients admitted in ICU.~   "
22151|NCT02767245|"~     Thyrotoxicosis is a hypermetabolic state in which there is increased utilization of~     thiamine. Thiamine deficiency has been observed in association with hyperthyroidism. Several~     studies documented that thiamine treatment could improve signs and symptoms of congestive~     heart failure, or even improve left ventricular ejection fraction in patients without~     thyrotoxicosis. This pilot study aims to evaluate prevalence of thiamine deficiency and~     assess improvement of cardiovascular function after receiving thiamine supplement in~     thyrotoxic patients.~   "
22152|NCT02767232|"~     The purpose of this study is to determine if the use of adjunctive catheter-directed~     thrombolysis (CDT), which includes the intrathrombus administration of rt-PA~     (Activase/Alteplase), can prevent post-thrombotic syndrome (PTS) in pediatric patients with~     symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard~     anticoagulation alone.~   "
22153|NCT02767219|"~     This is a phase III randomised controlled pilot study which aims to assess the effectiveness~     of the use of bevacizumab in patients who have undergone trabeculectomy surgery, which~     appear to be showing early signs of failure.~   "
22154|NCT02767206|"~     The study aims to evaluate the feasibility of transnasal endoscopy in patients with portal~     hypertension, cirrhotic and non-cirrhotic. The incidence of the procedure's adverse effects,~     the patient's tolerance and his/her opinion about the exam are analyzed. In addition, the~     interobserver matched for the discoveries found in the study is carried out.~   "
22155|NCT02767193|"~     single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective,~     placebo-controlled, partially masked, parallel group. Patients will be assigned to one of~     the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic~     cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo~     with pegylated interferon.~   "
22223|NCT02766283|"~     To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in~     pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice~     setting.~   "
22159|NCT02767141|"~     Children without consistent access to sufficient and nutritious food show sustained~     disadvantages. To improve food security, households utilize three types of coping~     strategies- participating in governmental feeding and financial assistance programs;~     obtaining food from nongovernment providers; and using individually developed strategies. To~     understand the interdependencies among strategies and decision-making processes used to~     select them, the investigators conducted a two-phased, mixed-methods study using a~     socio-ecological theoretical framework. First, employing a cross sectional, observational~     design the investigators administered in-person surveys to 320 adults in very low food~     secure (VLFS) households with children. Over 1 year later, the investigators repeated select~     questions and conducted in depth interviews with a cohort (n=28) of participants.~     Descriptive statistics defined magnitude of associations among strategies. Following~     bivariate analysis, the investigators assessed interdependencies and factors affecting~     relationships with log-linear models. The investigators analyzed interviews using an~     hierarchically ordered, analytical coding structure. With Qualitative Comparative Analysis~     (QCA), the investigators developed typologies of VLFS and created models treating food~     security as an outcome. The association of soup kitchen use and nutritionally risky behavior~     was altered by Supplemental Security Income (SSI) or Social Security Disability Insurance~     (SSDI). Food safety-related risky behavior level related to intensity of food pantry use by~     participation in school food programs. Supplemental Nutrition Assistance Program (SNAP) did~     not affect the association between soup kitchen use and risky food safety behaviors. Key~     interview constructs included becoming and being short of food; coping strategies; decisions~     used to inform choice of strategies; and managing a devalued social status. Improved income~     stability was a necessary condition for improving food security.~   "
22160|NCT02767128|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered~     orally in healthy adult volunteers. It is a randomized multiple treatments, single dose~     study.~   "
22161|NCT02767115|"~     The aim of this study was to formulate a mucoadhesive gel of grapes seed extract (GSE)~     followed by short-term clinical study for the effectiveness of this gel onto the pocket~     depth (PD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) when~     applied in periodontal pockets as an adjunct treatment for chronic periodontitis.~   "
22162|NCT02767102|"~     Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the~     serum and salivary concentrations and antioxidant power of MLT after the intake of a glass~     of red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine~     rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and~     double-blind design. Serum and salivary MLT will be measured by liquid chromatography~     coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively.~     The ferric ion reducing antioxidant power (FRAP) will be analyzed.~   "
22163|NCT02767089|"~     The purpose of this study is to further access the utility of biochemical and clinical~     biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints~     against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated~     in adult healthy volunteers.~   "
22164|NCT02767076|"~     To identify the value of using the ultrasound in applying a commonly used regional~     anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark~     guided approach, regarding the efficiency of the anaesthetic technique, incidence of~     associated common complications and patient's satisfaction.~   "
22165|NCT02767063|"~     Patients will be randomized in phase II trials to continue on the same TKI versus one of the~     alternative treatment approaches. If a patient is not eligible for one of the treatments, he~     (she) will be randomized between the options for which he (she) is eligible.~      The trial will start with current available treatment options (experimental arms). New~     available treatment options may be open at any times later on. Authorized TKIs are imatinib,~     nilotinib, dasatinib, bosutinib and ponatinib.~      For all options the treatment duration is for a minimum of 12 months and will be continued~     in the absence of adverse events following investigator decision. Each therapeutic option~     will be detailed in term of combination modalities, dose, dose adaptation, specific~     warnings, specific exclusion and inclusion criteria. The decision to introduce a new option~     will depend on the general pace of recruitment and on the assessment of the potential~     efficacy and safety of the new treatment, and will be implemented after scientific review by~     a protocol amendment.~      Primary objective:~      A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib,~     bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative~     Incidence of MR4.5 as compare to control.~      Secondary objectives:~      A. To determine the safety of selected therapies~      B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms~      C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms~      D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies)~     by 12, 24, 36, 48 months in experimental and control arms~      E. To estimate treatment free remission (TFR) in patients eligible for discontinuation~     studies~      F. To investigate the relationship between biological activity and the clinical efficacy of~     the selected therapies~      G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells~     and other biological markers of interest~      H. To estimate duration of response, progression-free survival, event free survival and~     overall survival.~   "
22166|NCT02767050|"~     The following observational study evaluates incidence of caries in smoking and smokeless~     tobacco based on habit history by clinical examination and DMFT index.~   "
22167|NCT02767037|"~     Currently, there is no clear diagnostic test that can be used to confirm the diagnosis of~     Parkinson's disease, or a biomarker that can track its progression. Patients with~     Parkinson's have many abnormalities of the autonomic nervous system, which may be related to~     Parkinson's changes outside of the brain. A new device called the SudoScan, which measures~     autonomic sweating changes, may be a simple way to test for autonomic changes in~     Parkinson's.~      The investigator plan to see whether SudoScan can identify Parkinson's disease and whether~     SudoScan abnormalities might be present even in early (prodromal) Parkinson's stages.~      The investigator will assess SudoScan in a group of Parkinson's patients, normal healthy~     controls, patients with non-Parkinson's neurodegeneration, and patients with REM sleep~     behavior disorder (an early/prodromal Parkinson's state). Abnormalities will be correlated~     with standard autonomic tests and with skin biopsy findings Parkinson's degeneration in the~     peripheral autonomic fibers.~      If the investigator can find a reliable way to diagnose and follow Parkinson's disease, he~     will be able to correctly identify Parkinson's (even in its earliest stages). This will~     improve the chance to find protective treatments against Parkinson's, by preventing false~     diagnosis and by providing a new marker to track disease progression.~      If successful, the investigator will aim to validate the findings on a large sample of~     Parkinson's and also to track changes over time in the original cohorts~   "
22168|NCT02767024|"~     Single center, prospective, randomized, non-blinded research study comparing intravenous~     vasodilator infusion vs. inotropic infusion in patients admitted to the hospital or in the~     emergency room at Montefiore Medical Center presenting with the diagnosis of acute~     decompensated systolic heart failure with low cardiac output but no hypotensive.~   "
22181|NCT02766842|"~     Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent~     structures, such as lymph nodes, is still showing advancements especially with the increased~     use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine~     needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions.~     The purpose of the study is to compare between the currently used, ProCore needles and the~     new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.~   "
22169|NCT02767011|"~     Abstract:~      It is intuitive that post discharge surgical complications are associated with increased~     patient dissatisfaction, and directly associated with an increase in medical expenditures.~     It is also easy to make the connection that many post hospital discharge surgical~     complications including surgical site infections could be influenced or exacerbated by~     patient co-morbidities. The authors of a recent study reported that female gender, obesity,~     diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic~     obstructive pulmonary disease, dyspnea, and neurologic disease were all of among significant~     predictors of surgical site infections after vascular reconstruction was performed. The main~     concern for optimal patient care especially in geographically isolated areas of West~     Virginia is to have early, expeditious, and prompt diagnosis of early surgical site~     infection with subsequent indicated interventions. This theme will lead to patient~     satisfaction, minimizing third party interventions and decrease the total cost associated~     with these complications. Nevertheless, it seems reasonable to believe that monitoring using~     telehealth technology and managing the general health care patients receive after a hospital~     vascular intervention will improve overall health and reduce post-operative complications.~      Aims/Objectives:~      1. The primary objective of the current project is to compare early and late outcomes for~     patients who receive post discharge health care monitoring (which includes using Telehealth~     electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine~     discharge instructions and no monitoring.~      Methods:~        1. Randomize patients who are scheduled to have revascularization interventions with groin~          incisions to receive either telehealth electronic health care monitoring or normal~          standard of follow-up care.~        2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications.~          In addition, have participants complete the follow-up survey questionnaires.~   "
22170|NCT02766998|"~     This is a prospective, single center, safety and feasibility trial to evaluate the use of~     autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will~     be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of~     congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal~     echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be~     harvested in a sterile fashion and the umbilical vein will be dissected free and preserved~     until first clinically indicated Stage I palliative procedure between day 3 and 7 of life.~     Subjects will be followed until their Stage II palliative procedure.~   "
22171|NCT02766985|"~     The purpose of this study is to make a standardized and scalable Rasch-built clinical~     severity scale to help in finding genetic and environmental modifiers of disease in~     Facioscapulohumeral muscular dystrophy (FSHD).~   "
22172|NCT02766972|"~     Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date.~     Therefore, advanced techniques are required to achieve an optimal result in treating these~     patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to~     facilitate microsurgical clip-reconstruction has been studied prospectively in a joined~     neurosurgical, anesthesiological and cardiological study.~   "
22173|NCT02766959|"~     This single-site, within-subject experimental basic research study is designed to analyze~     the hypothesis that allele-specific expression of the bitter taste receptor T2R38 in taste~     tissue of individuals heterozygous for the taste receptor gene TAS2R38 correlates with that~     in nasal epithelium, and is responsible for differences in acyl-homoserine lactone-induced~     respiratory defenses. Subjects will include 100 predominantly European adults without~     chronic rhinosinusitis who will be undergoing a sinonasal procedure for reconstructive~     purposes. All subjects will provide saliva samples for genotyping, from which 25 subjects~     heterozygous for TAS2R38 (AVI/PAV) will be identified. These individuals will be asked to~     complete a beverage frequency questionnaire and taste test prior to the procedure that will~     evaluate for a number of compounds, among them bitter ligands specific to T2R38. Their~     tongue will also be photographed to evaluate the anatomy of their fungiform papillae, the~     mushroom-like structures on the tongue which contain taste buds. Subjects will subsequently~     provide nasal epithelium and taste tissue, which will be processed to 1) evaluate for~     allele-specific expression of TAS2R38 mRNA in both the taste and nasal tissue, with the~     nasal tissue concurrently being cultured in an air-liquid interface system to 2) assess the~     AHL-induced respiratory defenses of ciliary beat frequency (CBF) and nitric oxide (NO)~     production. Should subjects require a subsequent sinonasal procedure for~     clinically-determined reasons, taste and nasal tissue will again be obtained and analyzed~     for TAS2R38 mRNA, allowing for 3) longitudinal evaluation of mRNA expression level.~   "
22174|NCT02766946|"~     Ventilatory support during critical phase result in inactivity of respiratory muscles~     especially diaphragm muscle. These inactivity also result in change of contractile~     capability and quick muscular atrophy.~      The aim of the study is to visualize the evolution of diaphragm thickness by echography~     during Mechanical Ventilation for patients with septic shock or acute respiratory distress~     syndrome and to compare with the evolution for patients under non-invasive ventilation and~     those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day~     10 (if patient still under a mode of ventilation or in the unit).~      The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy,~     which is not involved in ventilation, in order to assess respective effect of ventilatory~     inactivity and undernutrition linked to intensive care.~   "
22175|NCT02766933|"~     The natural history and response to therapy of chronic hepatitis B infection in West Africa~     are currently poorly understood. In this study, employees of the Cameroon Baptist Convention~     Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will~     be offered enrollment. Disease monitoring and treatment will be provided following current~     WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens~     will be frozen for future analysis.~   "
22176|NCT02766907|"~     Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic~     membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize~     the ocular surface integrity and intraocular lens calculation before cataract surgery.~   "
22177|NCT02766894|"~     Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate,~     deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch~     statistical analysis for underlying factors are done.~   "
22178|NCT02766881|"~     To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in~     women with low to moderate risk DCIS who have had breast conserving surgery~   "
22179|NCT02766868|"~     Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with~     marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on~     a new treatment strategy with high-dose chemotherapy regimen consisting of~     fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning~     regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.~   "
22180|NCT02766855|"~     The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the~     treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.~   "
22184|NCT02766803|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of~     reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated~     ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces~     androgen production.~      This study is designed to evaluate the endocrine and metabolic effects of simvastatin and~     resveratrol on PCOS.~      Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects~     of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or~     administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital.~     PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline~     and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum~     total testosterone and the fasting insulin level.~   "
22185|NCT02766790|"~     TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild~     telomeres. A telomere is a region of repetitive DNA at the end of a chromosome, which~     protects the end of the chromosome from deterioration. They shorten during cell division and~     eventually signal an irreversible state of growth arrest known as cellular senescence. The~     length of a person's telomeres is an indicator of his or her overall health status; short~     telomeres have been associated with cellular aging and dysfunction.~   "
22186|NCT02766777|"~     A study of the safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to < 18 years~     diagnosed with Functional Constipation~   "
22187|NCT02766764|"~     Two hundred and thirty women with expected poor ovarian response undergoing IVF/ICSI will be~     randomly divided into 2 equal groups using computer generated random numbers. Group 1 will~     receive DHEA 25 mg (DHEA 25mg, Natrol , USA) t.d.s for 12 weeks before starting IVF/ICSI~     cycle in addition to Growth hormone (GH; Somatotropin, Sedico, Egypt) 4 IU on day 6 of human~     menopausal gonadotropin (hMG) stimulation in a daily dose of 2.5 mg subcutaneous (sc) until~     the day of human chorionic gonadotropin (hCG) triggering Group 2 will receive an oral~     placebo t.d.s. daily for 12 weeks before ICSI in addition to a sc placebo similar to GH~     daily from day 6 of stimulation until the day of hCG trigger.~   "
22188|NCT02766751|"~     This study is designed to look at two different programs that may help people who are HIV+~     and have pain and depression. The investigators are trying to understand how to help people~     learn to live better lives even with these chronic illnesses.~   "
22189|NCT02766738|"~     This study aims to test which of three exercise programs, previously demonstrated valuable~     for residential aged care adults, has the greatest benefit for walking speed and the~     spatiotemporal parameters that define it. The programs to be included are:~        1. The GrACE program and~        2. The GrACE plus Gait specific training.~   "
22190|NCT02766725|"~     The aim of this study was to develop and characterize in situ thermosensitive gels for the~     vaginal administration of sildenafil as a potential treatment of the endometrial thinning~     that occurs as a result of the use of clomiphene citrate in induction of ovulation in women~     with World Health Organization type II EU gonadotrophic anovulation.~   "
22191|NCT02766712|"~     This is a two arm randomized, paired prospective study comparing the percentage of time~     spent above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the~     setting of pacing versus non-pacing. This study is designed to compare the percentage of~     time spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion~     locations.~   "
22192|NCT02766699|"~     The purpose of the Cerebral EDV study is to determine the safety and tolerability of~     EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The~     study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is~     effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).~   "
22193|NCT02766686|"~     ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients~     suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe~     genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events~     (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain~     assessment of quality of life, biochemical recurrence and recurrence free survival as well~     as overall survival and economic comparison between photon and proton therapy.~   "
22194|NCT02766673|"~     Currently several dose schedules of Albuterol are administered via nebulization to infants~     in the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved~     for this population (under 2 years) there is no standard recommended dose. Aerosolized~     Albuterol is one of the most widely used therapies that are utilized for infants with~     chronic lung disease. The common practice in the N/IICU is weight base dosing of all~     medications. This contradicts the aerosol science recommendations, which advise not to~     titrate doses by weight as the patient naturally self-regulates their dose according to the~     change in minute ventilation with age. In addition, the wide use of aerosolized Albuterol in~     the infant with Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in~     this disease. Understanding the appropriate dose for effective treatment as well as the~     indication for use in the BPD population would provide the clinician with useful guidelines.~      The investigators propose to analyze the safety and efficacy of aerosolized albuterol in~     infants with BPD comparing the recommended dose per aerosolization literature with the~     common dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as~     placebo.~   "
22195|NCT02766660|"~     The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL),~     macula and optical disc parameters obtained by optical coherence tomography (OCT), and~     intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO)~     and healthy controls.~   "
22196|NCT02766647|"~     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is~     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds~     of white blood cells (WBC) known as neutrophils. This type of white cell is important in~     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by~     increasing the number of neutrophils that are produced in the body.~      This is important for patients who have low neutrophils due to chemotherapy, other~     treatments such as bone marrow transplant or certain other conditions with symptoms/problems~     related to low neutrophil counts. The main aim of the study is to test how Filgrastim~     Hospira works in the body compared to Neupogen®.~   "
22197|NCT02766634|"~     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is~     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds~     of white blood cells (WBC) known as neutrophils. This type of white cell is important in~     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by~     increasing the number of neutrophils that are produced in the body.~      This is important for patients who have low neutrophils due to chemotherapy, other~     treatments such as bone marrow transplant or certain other conditions with symptoms/problems~     related to low neutrophil counts. The main aim of the study is to test how Filgrastim~     Hospira works in the body compared to Neupogen®.~   "
22198|NCT02766621|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections~     of PF 06823859 in healthy subjects.~   "
22199|NCT02766608|"~     This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung~     function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI~     320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.~   "
22200|NCT02766595|"~     Children referred for routine EEG studies for suspected absence seizures will be asked, upon~     caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine~     position and while sitting up. We aim to demonstrate that hyperventilation is more effective~     in eliciting absence seizures in a sitting position than while lying down.~   "
22201|NCT02766582|"~     Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the~     Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary~     peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin~     every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by~     maintenance pembrolizumab IV.~   "
22202|NCT02766569|"~     The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II~     device in patients with closure of secundum atrial septal defects (ASD II).~   "
22203|NCT02766556|"~     The present study was designed to test the hypothesis that dexmedetomidine added to~     ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would~     enhance the duration and effect of analgesia when compared with ropivacaine alone, and their~     influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.~   "
22204|NCT02766543|"~     A prospective, multi-center, single-arm study, planned in 110 patients. The primary~     objective of the study is to further evaluate the safety and efficacy of a magnetic~     resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended~     to ablate prostate tissue of patients with localized, organ-confined prostate cancer.~   "
22205|NCT02766530|"~     The investigators will use integrated PET/MR for the goals below:~        1. Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced~          MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to~          monitor treatment response.~        2. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate~          the correlation of PET results versus MRS, DCE MRI.~        3. Compare clinical staging by PET/MR and by clinical assessment.~        4. On pre-chemotherapy studies, to investigate the association of molecular marker status~          with the dynamic and static PET, MRS and DCE MRI parameters.~   "
22206|NCT02766517|"~     This is a study of participants with a diagnosis of migraine who completed another clinical~     trial known as I5Q-MC-CGAB (CGAB) (NTC02163993). In CGAB, participants received either~     LY2951742 or placebo. This study will evaluate how certain biomarkers may be related to the~     participant's response in CGAB. The study will last about five days.~   "
22207|NCT02766504|"~     the study aims to evaluate the role of airway ultrasound as a new evolving modality in~     assessment and management of airway in surgical patients~   "
22208|NCT02766491|"~     Cerebral palsy (CP) has a prevalence of 1.5-3 per 1000 live births, making it the most~     common neurological disorder among children in Europe. One of the most frequently observed~     problems in CP is hypertonia, i.e. increased muscle tension, which can result in~     contractures. Stretching therapies are widely used as a treatment for contractures, but with~     highly variable success. Therefore, efforts are needed to improve the efficacy of stretching~     interventions. The investigators hypothesise that increasing the stiffness of the tendon~     relative to the muscle, by resistance training, prior to stretching will improve the~     efficacy of stretching interventions in children with CP. In a RCT design the investigators~     will compare a group of children receiving a combined strengthening-stretching intervention~     of the calf muscle to a control group receiving conventional stretching exercises in~     combination with upper limb exercises. Outcome measures will include muscle-tendon structure~     and gait analysis to assess functional improvements. This research will improve the~     understanding of muscle responses to stretching interventions in children with CP and can~     lead to more effective stretching therapies.~   "
22209|NCT02766478|"~     Genistein is a natural supplement that comes from soy. The purpose of this study is to see~     if genistein has any effect on preventing or reducing heart disease and diabetes risk in men~     receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional~     measures, blood markers and imaging tools will assess body composition, lipid levels and~     insulin resistance. Information from this pilot study will increase understanding of~     interventions which may prevent or reduce health risks during prostate cancer treatment.~     This project involves 24 men who will receive androgen deprivation therapy for prostate~     cancer.~   "
22210|NCT02766465|"~     This is a clinical trial that will compare survival and sickle related outcomes in~     adolescents and young adults with severe sickle cell disease after bone marrow~     transplantation and standard of care. The primary outcome is 2-year overall survival.~   "
22211|NCT02766452|"~     The objectives of this study were to evaluate the effect of a preoperative educational DVD~     on parents' knowledge acquisition, participation and anxiety related to their child's care~     in the recovery room (RR). It also aimed at evaluating the DVD in terms of children's~     postoperative distress, pain, analgesic requirements and length of recovery.~   "
22212|NCT02766439|"~     between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg~     etanercept injection subcutaneously twice a week. The follow-up time of the study was 24~     weeks.~   "
22213|NCT02766426|"~     Sincev the adipose tissue as been identified as a metabolic active tissue that produces and~     regulates pro-inflammatory factors, the investigators studied the relationship between~     cytokine changes and maternal body composition.~      The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in~     pregnant women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is~     related with changes in body composition.~      Women enrolled in the study were provided nutritional advices about lifestyle: a proper~     nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the~     American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling~     with a dietitian and a gynaecologist, both attendant since the enrollment.~      Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and~     at 36-38 weeks.~      Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body~     composition (i.e. fat mass and fat free mass) at first and third trimester.~   "
22214|NCT02766400|"~     Individuals with cognitive impairments after stroke sustain significant disability in their~     daily tasks, and account for a significant proportion of stroke-related healthcare costs.~     This loss of independence is costly because individuals with stroke-related cognitive~     impairments require more rehabilitation and more resources to support their living, whether~     in institutional or community settings. The proposed study examines the effects of directed~     and guided training on the recovery of independence with daily activities in adults with~     stroke-related cognitive impairments in acute rehabilitation. The investigators predict that~     patients in both groups will demonstrate significant improvement in independence with daily~     activities in the first 12 months after rehabilitation admission, but that patients who~     receive guided training will demonstrate significantly more improvements than patients who~     received directed training.~   "
22215|NCT02766387|"~     Lower limb amputation (LLA) is a major public health problem, with significant human and~     financial impact. Epidemiological data remain scarce in the literature. The primary~     objective of the equipment of lower limb amputees is to give a walking ability and autonomy~     that are closest to the previous state before the amputation. About~     microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who~     benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare,~     Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360~     (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being~     equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to~     adapt instantly to the user's walking speed changes. They are indicated in the proximal~     amputations of the lower limbs from knee disarticulation included. Their prescription can~     only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are~     subject to four criteria attribution and reimbursement by the List of Products and Services~     Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the~     ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous,~     descend an inclined slop of 15% and to walk down the stairs step by step. These criteria~     must be validated after a minimum trial period of 15 days.~      These attribution criteria raise the question today of how they are measured, no~     recommendation defining this procedure. While many standardized assessment tests of~     different gait parameters are available and used in clinical research, the attribution~     criteria are not being built in reference to these tests.~      The overall objective of the study is to evaluate the diagnostic value of two simple~     clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients~     with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).~   "
22216|NCT02766374|"~     The goal of this research study to see whether biofeedback therapy helps treat asthma, and~     if so, how it works. Biofeedback is a treatment method that can teach how to bodily control.~     Biofeedback is widely used to help people relax. In this study however, the investigators~     want to learn if a specific type of biofeedback actually improves asthma in a way that might~     allow the reduction or elimination of other controller treatments like~     inhaled-corticosteroids.~   "
22217|NCT02766361|"~     The study consists of a clinical trial comparing a new structured group intervention,~     denominated Cognitive-Behavioral Rehabilitation, to treatment as usual (TAU) for bipolar~     patients. The new approach is a combination of cognitive behavioral strategies and cognitive~     rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To~     be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be~     18 to 55 years old, in full or partial remission and have an IQ of at least 80. A~     comprehensive neuropsychological battery, followed by mood, social functioning and quality~     of life assessments will occur in three moments: pre and post-intervention and after 12~     months.~   "
22218|NCT02766348|"~     Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will~     receive only chemotherapy.~   "
22219|NCT02766335|"~     This phase II trial studies how well anti-B7H1 monoclonal antibody MEDI4736 (MEDI4736) works~     in treating patients with stage IV squamous cell lung cancer that has come back after~     previous treatment. This is a non-match sub-study that includes all screened patients not~     eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as MEDI4736, may be~     able to shrink tumors. MEDI4736 may be effective in treating patients with squamous cell~     lung cancer.~   "
22220|NCT02766322|"~     The investigators wish to study the effects of alcohol on three forms of bariatric surgery,~     Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric~     banding (LAGB). The surgery is not part of the clinical trial. If insurance does not cover~     the procedure, then the patient is responsible for payment of the surgical process. The~     investigators are doing pre and post surgery testing to provide a better understanding of~     the effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution~     and elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of~     alcohol on driving.~   "
22221|NCT02766309|"~     This study aims to examine the relation between health status and self-assessment of health~     condition, their relation to healthcare services utilization, and also to identify the~     profile of those who assess their health condition as mediocre to poor in general population~     and according to nationality.~   "
22222|NCT02766296|"~     PTSD is characterized by recurrent intrusion of trauma-related memories and images that~     cause significant distress and impairment to the affected individuals. The current project~     aims to examine whether computerized emotional working memory training (eWMT) can help~     improve working memory capabilities and reduce trauma-related emotional symptoms among~     individuals with elevated trauma-related symptoms. Participants will be randomly assigned to~     one of the two computerized training programs. At baseline, post-training, and 1-month~     follow-up, participants will be assessed with respect to their emotional symptoms and~     working memory-related cognitive performance. Pending successful outcomes, this study will~     provide important knowledge that will guide the future efforts to develop an effective,~     accessible, and cost-efficient intervention program.~   "
22224|NCT02766270|"~     The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO~     II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that~     lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation~     (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment~     strategies are not adequate for this subtype of lower-grade glioma.~      The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy~     with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with~     IDH-wt and TERTp-mut.~   "
22225|NCT02766257|"~     Long surgical wait-times and limited hospital capacity are common obstacles to surgical care~     in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to~     these problems. The aim is to study the introduction of ambulatory surgery in a pediatric~     hospital in SSA.~      This is a cross-sectional descriptive study which took place over 6 months. It includes all~     the patients assigned to ambulatory surgery in the Pediatric University Hospital in~     Ouagadougou, Burkina Faso.~   "
22226|NCT02766244|"~     Three patients were recruited for assessment of ICG fluorescence in burns.~   "
22227|NCT02766231|"~     Type & Design:~      Post-market, international, multicentre Prospective, parallel groups, open-label, baseline~     controlled~      Objectives:~        1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS~          designs~        2. Incidence of adverse events and identification of possible risk factors for~          unsatisfactory results~        3. Mid-term survivorship of the implants~   "
22228|NCT02766218|"~     The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments~     with mother-toddler dyads who participated in a study that is testing the effects of a~     multicomponent lifestyle intervention as a means to prevent excessive gestational weight~     gain in obese women. Specifically, dyads will be invited to participate in home-based~     assessments to videotape an evening meal, have anthropometric measures taken, and complete~     study questionnaires. The overall goal is to understand factors related prospectively to~     responsive feeding between mothers and toddlers at 18 months; determine whether responsive~     feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and~     explore which factors are most strongly predictive of child zBMI change from birth to 36~     months.~   "
22229|NCT02766205|"~     The aim of the proposed study is to identify predictors of covert atrial fibrillation (AF)~     in Embolic Stroke of Undetermined Source (ESUS) patients and develop a prognostic score for~     the identification of covert AF in this population.~   "
22230|NCT02766192|"~     Background: The poor prognosis and public health burden of PTSD necessitates the development~     of more effective and broader treatment approaches. In the etiopathogenesis of PTSD, trauma~     memories become ingrained into key brain areas through conditioned learning and are~     triggered by various situations of daily life. The brain glutamate system plays a key role~     in the process of trauma learning and trauma memories via long-term potentiation. Ketamine~     administration modulates the glutamate system and has been used in the treatment of~     depression and PTSD. Previous studies demonstrate that a single low dose of ketamine rapidly~     improves symptoms of refractory PTSD and treatment resistant depression. Unfortunately the~     observed response is short-lived (4-7 days, maximum up to 2 weeks) and multiple doses often~     produce unacceptable side effects. TIMBER (Trauma Interventions using Mindfulness Based~     Extinction and Reconsolidation for trauma memory) psychotherapy, is a manualized and~     translational mindfulness based cognitive behavioral therapy specifically designed to target~     trauma memories and their expressions in PTSD patients. The placebo controlled pilot study~     examined the efficacy of a protocol combining a single infusion of low dose ketamine~     (0.5mg/kg) and TIMBER psychotherapy in subjects suffering from chronic PTSD. The objective~     of this pilot study was to optimize and individualize treatment of chronic PTSD using a~     rapid, effective, trauma specific, user friendly and inexpensive approach that uses cutting~     edge psychopharmacological combined with novel psychotherapeutic approaches.~      Methodology: The randomized, double blind, placebo-controlled pilot study used a crossover~     design. Ten subjects with refractory PTSD were assigned to one of two arms: one arm (n=5)~     received combined ketamine infusion and TIMBER therapy (TIMBER-K arm) and the second (n=5)~     received combined placebo (normal saline) infusion and TIMBER therapy (TIMBER-P arm). All 10~     subjects received a short version of TIMBER therapy after 10 minutes of onset of the~     infusion in which reactivation of trauma memories was initiated in a controlled manner using~     standardized scales and scripted narrative of the index trauma. This was followed by a~     standardized mindfulness based cognitive therapy module to quickly de-escalate the arousal~     symptoms followed by induction of detached observation and reappraisal of the trauma~     experience. After completion of the 40-min infusion, all subjects were trained on the full~     version of TIMBER therapy using methods of mindfulness based graded exposure therapy and a~     twice-daily schedule of home practice was initiated. The investigators are currently in a~     process of recruiting fifty more subjects to examine the effects in a larger sample.~   "
22231|NCT02766179|"~     The objectives of this study is to compare short-term outcomes of CPAP and Adjustable~     thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a~     randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary~     outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ~     ESS, and AHI or RDI, respectively.~   "
22232|NCT02766166|"~     By integrating approaches from the physical, biological, computational, statistical and~     clinical sciences, this study will test the hypothesis that early diagnosis of subclinical~     signatures of critical illness encoded within physiological signals complements conventional~     clinical predictors by providing unique prognostic insight. Early diagnosis of these~     subclinical signatures may lead to earlier treatment that can save additional lives. Our~     goal is to validate predictive algorithms and identify subclinical signatures of illness,~     ranging from asymptomatic adults in the community to very sick patients in the hospital.~   "
22233|NCT02766153|"~     Myeloproliferative disorders (MPD) include chronic myeloid leukemia (CML) (Ph +) and~     essential thrombocythemia (ET), the polycythemia vera (PV), myelofibrosis (MF) called SMP~     Ph. CML is the ultimate model of carcinogenesis. SMP is a characterized by a malignant~     monoclonal proliferation of a pluripotent hematopoietic progenitor determined by the~     presence of a balanced translocation between chromosomes 9 and 22 (Ph chromosome) which~     leads to major changes of a large number of cell functions. Investigators now believe that~     within the bone marrow exist two types of hematopoietic niches' niche osteoblastic /~     endosteal and vascular niche, controlling the maintenance and differentiation of~     hematopoietic stem cell pool. The endosteal niche, is a hypoxic region near the endosteal~     trabecular, which provides protection to deeply dormant stem cells. Data from the literature~     suggest that in the SMP, especially CML, the interaction of malignant stem cells with the~     microenvironment niche Endosteal could favor their survival and resistance to treatment. The~     therapeutic management of CML was upset by the use of tyrosine kinase inhibitors (TKIs).~     However, despite these advances, even in situations of undetectable residual disease, it has~     been observed relapses of the disease stopped TKI leaving suggest that there is a resistance~     of leukemic stem cell to TKI.~      Work in the group Bipoa Bio Engineering and Pathophysiology Osteo-Articular helped develop~     a 3D model of ex vivo bone formation, which can mimic the endosteal niche. the goal is to~     apply this model to the SMP of hematopoiesis by referring to normal hematopoiesis. it will~     be tested the hypothesis that the endosteal ex vivo recess of the 3D modeling allows to~     highlight a special interaction can promote the persistence of the leukemia stem cell~     despite the use of effective therapies.~   "
22315|NCT02765087|"~     The purpose of this study is to determine the diagnostic utility of the device 'Electronic~     Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the~     current gold standard.~   "
22234|NCT02766140|"~     The present trial will be performed to evaluate whether SHR1020 in combination with~     docetaxel in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is~     more effective as compared to placebo in combination with docetaxel. A secondary aim is to~     obtain safety information as well as information on quality of life of patients treated with~     SHR1020 in combination with docetaxel.~   "
22235|NCT02766127|"~     Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering~     material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic~     due to radiotherapy for head and neck cancer.~      Methods: A total of 17 patients were selected for the study. The study was conducted as a~     split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3)~     Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary~     flow was recorded for each patient according to the method described by Sreebny. The pain~     experience was generated by a cold stimulus directly to a sensitive tooth surface and~     assessed using the Visual Analogue Scale (VAS). The response was recorded before the~     application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2),~     4-weeks (POST-3) and 12-week controls (POST-4).~   "
22236|NCT02766114|"~     Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm~     length.~   "
22237|NCT02766101|"~     The purpose of this study is to examine whether an exergaming, aerobic physical education~     (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and~     classroom functioning among children with behavioral health challenges attending a~     therapeutic day school. After following an approved consent/assent process, children~     attending the school were randomized by classroom to take part in either 7 weeks of the~     experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week~     washout period, children then crossed over into the other arm.~   "
22238|NCT02766088|"~     The purpose of this study is to describe the burden of DENV illness among household members~     aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.~   "
22239|NCT02766075|"~     The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program~     (STEP) can safely improve the frailty status in patients with symptomatic severe aortic~     valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).~   "
22240|NCT02766062|"~     The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the~     effects of early postoperative cognitive function in elderly patients with metabolic~     syndrome.~   "
22241|NCT02766049|"~     The aim of this study was to assess tolerability and safety of three different formulations~     of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV~     chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with~     HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable~     impact was also assessed.~   "
22242|NCT02766036|"~     The aim of this study is to determine the impact of Propolis on proteinuria reduction and~     protection of the glomerular filtration rate in chronic renal failure patients.~   "
22243|NCT02766023|"~     This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that,~     following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel,~     Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week~     incidence of BV recurrence when compared to placebo. The primary objectives of this study~     are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as~     compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with~     MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by~     comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.~   "
22244|NCT02766010|"~     1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring~          Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH,~          Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium,~          Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine,~          Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac~          index, stoke volume and blood gases compared with the simultaneous results from~          hospital references device (when available)~        2. Hypothesis- Human physiological biomarkers may be measured from the color distribution~          of the internal or external (skin) tissue. The technology of the TensorTip device is~          based on the color distribution of the peripheral blood tissue, which enables the~          measurement of certain biomarkers and vital signs under consideration~   "
22245|NCT02765997|"~     This is an open label, interventional, randomized phase II trial comparing StemRegenin-1~     (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord~     blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning.~     A 2:1 randomization will be employed with a higher chance of being assigned to the~     experimental arm.~   "
22246|NCT02765984|"~     Trans vaginal ultrasound with a partially full bladder will be done at gestational age~     earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial~     cavity and the distance between the implantation site and the internal cervical os . Doppler~     assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue~     to detect resistance index.~   "
22247|NCT02765971|"~     540 consented women for being enrolled in this clinical trial and candidates for elective~     cesarean section will be divided into 3 groups:~        -  Group A, 180 women will receive sugarless gum after their operating room discharge by 3~          hours for at least half an hour at two hours interval.~        -  Group B, 180 women will receive laxatives after their operating room discharge by 3~          hours.~        -  Group C, 180 women as control group, they will not receive neither gum nor oral fluids.~          They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds~          .~   "
22333|NCT02764853|"~     Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at~     developing an intervention for Black women living with HIV to address psychosocial factors~     (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and~     prescribed traditional gender roles) that have been associated with medication nonadherence~     or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.~   "
22248|NCT02765958|"~     Sleep is a fundamental need for human and is associated with the working performance and the~     disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased~     largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more~     important recently. In clinical settings, the analysis of daily sleep quality depends on~     actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really~     convenient for patients. In this trial, the investigators will measure the subjects' ECG~     signal and movement using a portable ECG device with motion sensor. On the other hand, the~     sleep stages are also obtained from the current wide-established measurement-~     polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our~     algorithm of artificial neural network. Then, the investigators can obtain the preliminary~     analysis of sleep quality can be obtained by using ECG device with our algorithm. It is~     helpful for doctors to realize the patent's sleep quality quickly~   "
22249|NCT02765945|"~     This is the second phase of a study designed to determine the immunological effects of~     long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis~     (phase 2). The results indicate that six months of moderate intensity exercise reduces bone~     resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral~     blood mononuclear cells.~   "
22250|NCT02765932|"~     This is a prospective study looking at the impact of psychosensory therapy and how it can~     diminish pain and consumption of pain medications. The primary study objective is to~     evaluate the change in Visual Analogue Score (VAS) score assessing for pain from Baseline,~     every day of inpatient stay, 7 days after leaving hospital (via phone), and 3 months~     post-op(via phone) and to correlate the psychosensory therapy and overall use of pain~     medications/narcotics.~   "
22251|NCT02765919|"~     The purpose of this study is to compare two diffrent brachytherapy treatment option in~     locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is~     effective in locoregional control and more convenient in terms of cost and time than 7 Gy~     brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.~   "
22252|NCT02765906|"~     Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all~     pregnancies. It contributes to a large proportion of maternal mortality worldwide and these~     deaths largely result from delayed diagnosis.~      A number of studies have shown that patient knowledge about preeclampsia is poor and that~     patient education can improve patient awareness. The investigators would like to find out~     what type of patient education is most effective. The investigators propose a three arm~     randomized controlled trial (RCT) where the first arm will receive a graphic card depicting~     signs and symptoms of preeclampsia, the second arm will watch an educational video on~     preeclampsia, and the third arm will have no visual form of patient education; they will be~     exposed only to the counseling they receive with their routine prenatal care. The card and~     video were both developed by the Preeclampsia Foundation and in a prior RCT the card was~     shown to be a useful educational intervention. This study would expand on this previous data~     by comparing the graphic card to an informational video available on the Preeclampsia~     Foundation's website~     (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool. Patients in the arm receiving the graphic card for educational intervention will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety before and after initial exposure to the educational interventions will be assessed. A follow up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to measure retention of knowledge. Patient medical records will be reviewed for delivery outcomes which will be recorded and compared.~   "
22253|NCT02765893|"~     This is a prospective, comparative randomized study. Our study population includes women~     with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.~      The two groups will include the study group, who will have their Foley catheter removed~     before leaving the operating room, and the control group who will have an indwelling Foley~     catheter overnight. The two groups will be assigned according REDCap randomization system.~   "
22254|NCT02765880|"~     The main purpose of the study is to examine to which extent abnormalities in the dynamics of~     neural activities observed in patients with psychosis is related to difficulties at ordering~     simple visual stimuli and/or personal events.~   "
22255|NCT02765867|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic~     profile of an injection of RBP-6000.~   "
22256|NCT02765854|"~     This randomized phase II trial studies how well ixazomib and dexamethasone or ixazomib,~     dexamethasone, and lenalidomide work based on the presence of the rearrangement of a gene~     called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in~     treating patients with multiple myeloma that has returned after a period of improvement or~     does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking~     enzymes called proteasomes needed for cell growth. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide~     may stimulate the immune system against cancer cells and may also prevent the growth of new~     blood vessels that tumors need to grow. It is not yet known whether ixazomib and~     dexamethasone, or ixazomib, dexamethasone, and lenalidomide are more effective in treating~     multiple myeloma.~   "
22257|NCT02765841|"~     This is a Phase 3 single-arm, open-label, international, multi-center clinical trial to~     evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH who are~     receiving stable lipid-lowering therapy, including LDL apheresis. The study is comprised of~     a 12-week Run-in Period, a primary 24-week Efficacy Phase, followed by an 80-week Safety~     Phase.~   "
22258|NCT02765828|"~     This purpose of this study is to determine if tongue strength and tongue ultrasound~     measurements differentiates patients with untreated late-onset Pompe Disease (LOPD) from~     patients with acquires/hereditary myopathies or neuropathies. It is hypothesized that~     abnormalities in tongue function and structure in patients with LOPD may be useful in~     discriminating this condition from others that have similar presentations.~   "
22259|NCT02765815|"~     This is a prospective, single-center, single-blinded, randomized, case-control study. The~     study is conducted by a single investigator at an orthopedic surgery institute, with a~     minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared~     with the surgeon's standard method (detailed below) for pain management intraoperatively.~   "
22412|NCT02763813|"~     Monocentric comparative group study comparing the efficacy and short-term tolerance of a~     propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the~     treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be~     equally effective and tolerated.~   "
22260|NCT02765802|"~     Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant~     human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and~     interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway~     that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated~     anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it~     is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in~     patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data~     from studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or~     hepatitis C virus (HCV), it is postulated that Lambda treatment could be associated with~     fewer adverse effects than IFN-α treatment. This Phase II study is designed as randomized,~     open-label study of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in~     patients with chronic HDV infection, and the primary objectives of the study are as follows:~        -  To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over~          a 48-week treatment period.~        -  To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.~   "
22261|NCT02765789|"~     Anti-glomerular basement membrane (GBM) glomerulonephritis is a rare autoimmune disease~     mediated by anti-GBM antibodies and characterized by acute renal failure due to diffuse~     crescentic glomerulonephritis. Established treatment is cyclophosphamide and corticosteroids~     to suppress anti-GBM production and daily plasma exchange to remove circulating anti-GBM~     antibodies. The vast majority of patients with anti-GBM glomerulonephritis develop~     irreversible end-stage renal failure despite this treatment. Immunoadsorption may lower~     anti-GBM titres more effectively than plasma exchange. The goal of this interventional open,~     non-randomized pilot study is to study the efficacy, adverse events, logistic feasibility~     and costs of immuno-adsorption for the removal of anti-GBM antibodies in patients with acute~     renal failure due to anti-GBM glomerulonephritis. Eight patients with acute renal failure~     due to anti-GBM glomerulonephritis with or without accompanying pulmonary involvement will~     be treated with daily immunoadsorption, instead of plasma exchange, until anti-GBM titres~     are undetectable. All other aspects of the treatment (e.g. immunosuppressive treatment,~     renal replacement therapy) will be standard. The primary study parameter is the number of~     days that anti-GBM antibody titre is above a toxic level, defined as >30 ELISA units.~     Secondary study parameters are the tolerability and adverse events of immunoadsorption, the~     logistic feasibility defined as the time interval between diagnosis and start of first~     immunoadsorption treatment and costs of immunoadsorption.~   "
22262|NCT02765776|"~     RAL is considered one of the better-tolerated antiretroviral medications, due to limited~     side effects and few long-term safety concerns. Five-year clinical trial outcomes and~     clinical experience have demonstrated durable virologic suppression in both treatment-naïve~     and treatment-experienced patients, including patients with extensive antiretroviral history~     and documented antiretroviral resistance. Studies have also exhibited low adverse effect~     rates and reliable long-term safety lending to improved tolerance. Several trials have~     evaluated the reduction in adverse effects in patients switched from various antiretroviral~     agents to RAL. Treatment-naïve studies have demonstrated a lipid-neutral effect in patients~     on RAL-containing regimens. When transitioning patients from a ritonavir-boosted PI regimen,~     statistically significant decreases in total plasma cholesterol, low-density lipoprotein,~     and triglycerides were demonstrated. Given its negligible interaction with the cytochrome~     P450 system, RAL displays minimal drug-drug interactions, making it a good option for ageing~     patients on multiple medications.~      This is an observational retrospective cohort in real world to describe RAL data, including~     NUC-sparing regimens, in aged HIV patients. It is a phase IV study. 90 patients will be~     enrolled from the Department of Public Health and Infectious Diseases of Sapienza~     University of Rome. More than 4000 HIV patients are followed at this Department of Public~     Health and Infectious Diseases of Sapienza University of Rome. More than 50% of these~     patients are ≥ 50 years. From 10 to 12% are treated with a raltegravir based- regimen.~      The primary endpoint will be the description of the proportion of participants with an HIV-1~     viral load < 50 copies/mL.~      The secondary endpoints will be:~        -  Change from Baseline in CD4+ T-cell counts, CD8 cell counts, CD4/ CD8 ratio~        -  Proportion of subjects with laboratory alterations~        -  Proportion of patients with adverse events (AE), serious adverse events (SAE), also~          according to their severity~   "
22263|NCT02765763|"~     This is a placebo-controlled blinded clinical evaluation of day and night skin care creams~     supplemented by Medicell Technology's composition of defensins and supportive molecules~     determine the skin hydration and anti-aging properties of the topical test articles after~     repeated application to the skin of human subjects.~   "
22264|NCT02765750|"~     The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group~     A and B patients will listen to a positive message under general anesthesia. Group C~     patients will not listen to the message. The postoperative pain, analgesic consumption and~     frequency of nausea, vomiting and emergence agitation episodes will be documented and~     compared between the 3 groups.~   "
22265|NCT02765737|"~     Multicenter, prospective, randomized, controlled feasibility trial to determine the safety~     and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as~     compared to Control alone for the treatment of second degree burns as assessed by time to~     healing and scarring~   "
22266|NCT02765724|"~     This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg~     pacritinib administered orally to patients with stable chronic liver disease and healthy~     control subjects.~   "
22267|NCT02765711|"~     This is a single-arm non-interventional cohort study. This study is to describe the~     contemporary use of ticagrelor in a real-world setting, to reflect its acceptance and~     patients' compliance, and to observe its one-year safety in patients with acute coronary~     syndrome in Fuwai Hospital.~   "
22268|NCT02765698|"~     The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission~     Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about~     specific sites in the body that the endometrial cancer may be present. If the PET/MRI is~     accurate and successful in providing this information, then women in the future may be able~     to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.~   "
22269|NCT02765685|"~     This is a biomedical study on a medical device. 120 patients will participate in this study~     and will be split into 2 groups:~        -  60 patients in the usual care group: these patients will receive the usual care~          proposed by their doctor for 12 months.~        -  60 patients in the ODRA group: these patients will wear the ODRA brace for 12 months~          in addition to their usual care. They will be instructed to wear the brace for at least~          6 hours per day, 5 days per week and to take it off during rest periods when lying~          down.~      The distribution of patients in the groups will be randomized. For this study, patients will~     be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6~     months and 12 months.~   "
22270|NCT02765672|"~     The main objective of this study is to discern if an Occupational Therapy Driving~     Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also~     investigate if results leads to reduced driving errors on the driving simulator and an~     on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving~     simulator at baseline after which they will be randomized into control and intervention~     groups. The intervention group will receive sessions of Occupational Therapy Driving~     Intervention by a trained driving rehabilitation specialist. The control group on the other~     hand will receive driving safety education sessions by a driving safety professional. Both~     groups will be evaluated for driving performance on the driving simulator to ascertain~     whether there have been changes in the number of driving errors at two and three months upon~     enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving~     records from The Department of Motor Vehicles will be analyzed to for changes in number of~     driving errors.~   "
22271|NCT02765659|"~     This implementation study is testing whether community members can use a 3-step model~     (prepare, roll-out and sustain) to implement an efficacious peer group HIV prevention~     intervention with fidelity and effectiveness in a single district in Southern Malawi. A~     collaborative partnership including university researchers and district government, health~     system and traditional leaders will support community volunteers in implementation. Both the~     implementation process and the effectiveness of the intervention when implemented by~     communities will be evaluated.~   "
22272|NCT02765646|"~     The objective of this study is to demonstrate the clinical performance of the Tryton Side~     Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to~     treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary~     Artery(LCX).~   "
22273|NCT02765633|"~     The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal~     subjects at risk of thrombosis.~   "
22274|NCT02765620|"~     Chemo-radiotherapy and targeted therapy are widely used as non-surgical treatments for solid~     tumors. Early assessment of treatment response is considered efficient and helpful to~     clinical management and personalized therapy.RECIST 1.1 criteria was accepted widely.~     Complete response (CR), partial response (PR), stable disease (SD), and progressive disease~     (PD) are defined in the RECIST criteria. This type of classification divides intrinsically~     continuous data (tumor size) into 4 bins, losing statistical power for ease of nomenclature~     and convenience. The 18F-FDG PET exam is based on metabolic information and considered to~     overcome limitations of anatomic imaging and more suitable for assessment of therapeutic~     response.PERCIST 1.0 proposes a series of detailed and unambiguous regulations about~     standardization procedures to ensure the reproducibility. Complete metabolic response (CMR),~     partial metabolic response (PMR), stable metabolic disease (SMD), and progressive metabolic~     disease (PMD) are defined in the PERCIST criteria.~      So far, there have several studies using metabolic-based PERCIST criteria in patients with~     solid tumors, including lung cancer, digestive tumor and lymphoma, etc. But all of these~     studies had limitations of small study sample, thus were need to be further investigated.~     Compared to RECIST, the advantages of PERCIST were to evaluate chemotherapy, especially~     targeted therapy, to distinguish PMR and SMD patients from SD group in RECIST, and to better~     predict the response rate. Recently, several studies applied PERCIST criteria to evaluate~     neoadjuvant chemotherapy in pancreatic cancer and rectal cancer, and revealed the metabolic~     response results were well related to pathology. All these studies conclude PERCIST criteria~     could help making clinical therapeutic decisions. Moreover, several studies have shown that~     PERCIST has advantage in predicting early response of several malignant tumors.~      The aim of this multicenter study is 1) to evaluate treatment response in newly diagnosed~     and pre-therapeutic patients with solid tumors who are going to receive a baseline , an~     early follow-up (after a certain period of treatment cycle) and a final (after treatment)~     18F-FDG PET/CT; 2) to compared PERCIST criteria to RECIST 1.1 criteria in prediction~     treatment response, especially in early stage of treatment; 3) to reveal the value of~     PERCIST criteria in clinical therapeutic management and tailed therapy.~   "
22275|NCT02765607|"~     In this observational study investigators examine the presence of circulatory oscillations~     in blood pressure, heart rate, and doppler laser flow before and after planned cardiac~     surgery.~   "
22276|NCT02765594|"~     Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the~     world.There is to date no curative therapy for patients with IgAN.It is considered that~     dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and~     interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in~     the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable~     impact on immune activation by the reduction of circulating activated immune cells that~     including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic~     cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF~     alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could~     retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may~     have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal~     protect effect. This will be a single center, prospective, randomized, controlled study to~     assess the utility of hydroxychloroquine in IgAN patients.~   "
22277|NCT02765581|"~     The purpose of this study is to evaluate the efficacy of verum acupuncture (VA) for the~     prevention of migraine without aura compared to non-penetrating sham acupuncture (SA) and~     usual care alone (UC). This study also aims to determine whether the intensity of deqi~     sensations and psychosocial factors (including patient expectations, patient personality~     traits, patient-doctor relationship, traditional Chinese medicine constitution, depression,~     anxiety, sleep quality, etc.) are associated with clinical outcomes.~   "
22278|NCT02765568|"~     Coronary revascularization improves survival for patients with coronary artery disease.~     However,many patients are left with poor physical and mental health. Traditional cardiac~     rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to~     traditional cardiac rehabilitation programming may however provide superior understudied~     benefits to patients with poor physical and mental health. Nordic walking (NW) and~     high-intensity interval training (HIIT) are two examples of alternative programs for cardiac~     rehabilitation, which may provide superior physical and mental health benefits when compared~     to traditional MICE. The main purpose of this project is, therefore, to determine the short~     and long term physical and mental health benefits of alternative cardiac rehabilitation~     modalities, including NW and HIIT on exercise capacity, quality of life and depression after~     a 12-week program.~   "
22279|NCT02765555|"~     The purpose of this study is to assess the safety, tolerability and PK profile of a single~     dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than~     risperidone.~   "
22280|NCT02765542|"~     The purpose of the study is to evaluate the feasibility and potential impact of an automated~     phone system in monitoring and improving self-care and health outcomes among patients with~     depression in Bolivia.~   "
22433|NCT02763540|"~     Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD.~     Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the~     same time. Between observers agreement will be assessed for each pairs of samples.~   "
22281|NCT02765529|"~     Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been~     reported in part due to the rising in life expectancy. For instance, exposure to air~     pollution, and in particularly to fine particles has been classified by the International~     Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly~     population particularly sensitive. However, no validated biomarkers have been identified to~     assess the exposure to fine particles maybe correlated to cancerogenesis.~      AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution~     exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses~     of fine particles.~      Secondly, the study aims to analyze, according to age, the leukocytes response to the urban~     pollution exposure.~   "
22282|NCT02765516|"~     The objective of the present Mitacs project is to determine and utilize information on~     associations between genetic predisposition pertaining to multiple single nucleotide~     polymorphisms (SNPs) and the degree of responsiveness of low-density lipoprotein cholesterol~     (LDL-C) lowering to plant sterols (PS). The predictive potential of SNPs associated with PS~     responsiveness will be evaluated using a randomized human intervention trial examining~     responsiveness of lowering blood LDL-C levels to PS intervention.~   "
22283|NCT02765503|"~     The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of~     accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy~     delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous~     cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus,~     nasopharyngeal and stage I-II glottic carcinomas.~   "
22284|NCT02765490|"~     The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),~     safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,~     odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected~     subjects without cirrhosis.~   "
22285|NCT02765477|"~     The number of patients with cardiovascular implantable electronic devices (CIED), including~     ventricular pacemakers, continues to increase. However, there are no accurate~     electrocardiographic (ECG) criteria to diagnose acute myocardial infarction (AMI), even if~     due to acute coronary occlusion (ACO), with a ventricular pacemaker in situ. In this~     retrospective, multicenter, case-control study the investigators will examine ECG criteria~     to diagnose ACO in patients with ventricular paced rhythms. During this process, the~     investigators will also create a database from which investigators will be able to answer~     multiple additional questions on this population of patients.~   "
22286|NCT02765464|"~     Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly~     increase mortality, length of stay, and costs, however detection has proven difficult as~     markers like elevated creatinine and decreased urine output may take days to manifest and~     are late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of~     Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has~     been shown to increase within 12 hours following renal insult, allowing assessment of risk~     for developing acute kidney injury. Therefore, the investigators plan to assess if acute~     kidney injury in critically ill trauma patients can be determined earlier using urinary~     TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been~     specifically evaluated in trauma patients at risk of AKI.~   "
22287|NCT02765451|"~     This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of~     clinical research in non-academic health institution. The randomization, in open~     label,determines the duration of the interventions. Half of participants will receive the~     interventions during 2 years, while the other half during 1 year.~   "
22288|NCT02765438|"~     Balance disorders are sometimes treated with exercises performed on unbalanced surfaces. The~     BOBO system allows connection of a standing platform attached to any of these surfaces, to~     a screen, where the user can control games with his or her body movements. In this study,~     the lower limb muscle activity of healthy individuals will be monitored during different~     games in order to assert the the ability of each game in strengthening certain muscle~     groups.~   "
22289|NCT02765425|"~     The research objective of this study is to determine whether an intervention and associated~     robotic device called Assisted Movement with Enhanced Sensation (AMES) can be used to~     enhance balance recovery following an unexpected loss of balance by conditioning areas of~     the brain involved in lower-limb (LL) motor control. It is hypothesized that AMES can~     improve balance recovery, gait, and reduce falls in near-frail elderly people by improving~     LL strength, speed, and coordination.~      AMES, is a medical intervention and robotic device originally developed to aid patients'~     recovery from injuries to the central nervous system that limit movement. Earlier published~     studies demonstrated a unique property of AMES, namely that it is capable of reducing~     sensorimotor impairment in the severely impaired, an underserved population of patients with~     brain and spinal cord injuries. AMES applies assisted movement, biofeedback, and sensory~     stimulation simultaneously and non-invasively to the upper or lower limb, the initial intent~     being to address impairments such as weakness, spasticity, sensory loss, and dyssynergia~     (i.e., co-contraction). These reductions in impairment are achieved through cortical~     plasticity. In the present study, the same methodology will be applied to the lower limbs of~     the near-frail elderly to reduce falls by training faster reaction times, stronger~     reactions, and more coordinated recoveries from slips and trips~   "
22290|NCT02765412|"~     The overall goal of this project is to test two strategies for implementing a shared~     decision making tool to be used by providers while talking to patients about lung cancer~     screening. Eight participating sites will be randomized to compare standard implementation~     with intensive implementation. The investigators will also determine the effect of allowing~     providers to design their own risk threshold algorithms into a lung cancer screening~     decision aid, Decision Precision. Additionally, the investigators will determine the factors~     that were most important for successful implementation of the shared decision making tool.~     Finally, the investigators will survey patients to evaluate the effects of Decision~     Precision on patient's knowledge of the risks and benefits of lung cancer screening, the~     quality of their decision making, and their satisfaction with care.~   "
22291|NCT02765399|"~     This study aims to evaluate the mechanisms underlying the effect of incretin therapy on~     lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of~     liraglutide on hepatic de novo lipogenesis.~   "
22292|NCT02765386|"~     When providing amplification post-implantation to residual acoustic hearing in the implanted~     ear, the lower frequency boundary can be modified to minimize or avoid overlap between the~     frequencies coded through acoustic hearing and those presented through electrical~     stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of~     modifying this parameter will be investigated in this study. To avoid the research being~     confounded by prior bias for a particular frequency allocation, the study will be conducted~     with newly implanted recipients.~      This study will also investigate whether tests which measure the ability to use low~     frequency hearing and objective measures can predict the preferred Fc and speech performance~     benefit.~   "
22293|NCT02765373|"~     This study is a prospective, controlled phase IV clinical trial among postmenopausal~     patients with hormone receptor-positive breast cancer.The main purpose is to compare the~     effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid~     levels of breast cancer patients.~   "
22294|NCT02765360|"~     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease~     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive~     ventilation (NIV). NIV consists of a machine (ventilator) that is blowing air inside a~     patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths~     help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.~      These changes can improve outcomes and quality of life. In order to provide appropriate~     ventilation for each patient, the ventilator can generate different types of blowing:~        -  Continuous positive airway pressure (CPAP) which delivers a constant flow of air~          through the mask~        -  Pressure support ventilation (PSV) which delivers a constant flow of air through the~          mask and, on top of that, delivers more flow when the patient begins to inhale~        -  Volume targeted ventilation which delivers a flow of air through the mask that is~          adjusted breath by breath in order to achieve a preset volume.~      These different type of blowing have consequences on patient comfort as well as on the~     improvement of their ventilation.~      To assess the improvement of the ventilation, currently blood tests are used, however, these~     reflect overall output and may miss more subtle changes in breathing that could affect how~     patients feel.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV on lung~     ventilation in real-time.~      The investigators hope to use the EIT technology to assess in real-time patients lung~     ventilation when they are using the NIV. The investigators hope that EIT will provide~     information on which type of blowing is more effective and more comfortable than the others.~   "
22295|NCT02765347|"~     The investigators intends to carry out a randomized, cross-over, prospective study which~     will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe~     the effects of metformin on glycemic control and insulin sensitivity in adolescents with~     T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.~   "
22296|NCT02765334|"~     A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER)~     system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute~     and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to~     chronic stroke patients.~   "
22297|NCT02765321|"~     This is a population-based natural experiment study aimed to examine the effect of a~     multi-approach intervention focused on physical activity and healthy eating promotion to~     individuals living in Jaguariuna city (São Paulo, Brazil).~   "
22298|NCT02765308|"~     Uveitis is a disease that affects over 2 million people around the globe, and can ultimately~     lead to blindness. The proportion of patients with uveitis who become blind has not been~     reduced over the past 30 years, and this is therefore an area that demands further research.~     One of the major causes of blindness in uveitic patients is the development of uveitic~     glaucoma, which occurs in 10-20% of uveitic eyes. This is likely to occur for reasons~     related to the uveitis itself, but can also be caused as a side effect of the~     corticosteroids used to treat uveitis. The raised IOP in uveitis is more difficult to treat~     than other types of glaucoma.~      To enable more effective treatment of uveitic glaucoma, the investigators need to understand~     more clearly the mechanisms which underlie this process. The investigators therefore propose~     a study to examine the contribution of altered aqueous dynamics to the development of raised~     IOP in uveitis.~   "
22299|NCT02765295|"~     This is a multi-center, randomized, double-blind, parallel-group trial. After a 2-week~     run-in period, eligible patients will be, based on the randomization codes kept in sealed~     envelopes, randomly assigned to receive usual care (mucolytics and/or chest physiotherapy)~     plus oxygen inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr~     daily for 12 consecutive months) provided by the sponsor. At 3 months after the~     end-of-treatment, a follow-up visit will be scheduled for all patients.~   "
22300|NCT02765282|"~     Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician~     per standard care.~   "
22301|NCT02765269|"~     The purpose of this study is to determine whether the Intelligent Pain Management System~     (IPMS) could make recording and interfering pain timely among cancer patients with pain. The~     system's usability, feasibility, compliance, and satisfaction will also be assessed.~   "
22302|NCT02765256|"~     To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage~     and antibiotics with or without an antifungal) in the management of active Crohn's Disease~     (CD) that is refractory to conventional, immunosuppressive therapy.~   "
22303|NCT02765243|"~     Patients with refractory and/or recurrent neuroblastoma have poor prognosis despite complex~     multimodel therapy and therefore, novel approaches are urgently needed. The investigators~     are attempt to treat this disease using T cells genetically modified with a 4th generation~     lentiviral chimeric antigen receptor (CAR) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified~     T cells can recognize and kill neuroblastoma through the recognition of GD2, a surface~     protein expressed at high levels on neuroblastoma but not on normal tissues. This study will~     evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory~     and/or recurrent neuroblastoma.~   "
22304|NCT02765230|"~     The purpose of this cross-sectional study is to compare bilateral anterior segment~     parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric~     cataract extraction with primary IOL implantation to explore any possible interocular~     differences and their possible relationships.~   "
22360|NCT02764489|"~     The purpose of this study is to:~        -  1. To compare the pharmacokinetics (PK) of Factor Eight Inhibitor Bypassing Activity~          (FEIBA component Factor II (FII) and safety of FEIBA reconstituted in a reduced volume~          of sterile water for injection (SWFI) versus regular volume SWFI, administered at the~          standard infusion rate of 2 U/min/kg~        -  2. To evaluate the safety of infusing reduced volume FEIBA at increased rates of 4 and~          10 U/min/kg in comparison to the standard rate of 2 U/min/kg~   "
22305|NCT02765217|"~     Recent studies showed that intestinal microbiota consist more than thousand bacteria, and~     these microorganisms play the role as balance and continuity of the anatomical and~     functional integrity gastrointestinal tract. Chronic diseases, nutritional factors,~     lifestyle factors and medications including antibiotics changes the host microbiota in short~     or long-term period. Antibiotics are the most commonly used drugs in pediatrics routine~     practice. Although frequency and severity of side effects alter the choice of drug, mild~     complications may be taken into consideration for treatment by a physician in the profit and~     loss balance. Our study group (PROBAGE Working Group) have been recently showed that~     Lactobacillus reuteri DSM 17938 reduced the duration of diarrhea in children with acute~     infectious diarrhea, and are safe and well-tolerated. In this study the investigators aim to~     evaluate the potential effect of Lactobacillus reuteri DSM 17938 on the prevention of~     antibiotic associated diarrhea in children.~   "
22306|NCT02765204|"~     The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell~     glucagon release.~   "
22307|NCT02765191|"~     A study of renal blood flow and renal oxygenation measured by magnetic resonance after a~     standardized fluid challenge and blood pressure elevation in critically ill, resuscitated,~     septic patients.~   "
22308|NCT02765178|"~     Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics~     associated with multiple psychological co-morbidities. Apathy has not been widely studied in~     patients with Tourette syndrome. Apathy can result in decrease in self-care and disease~     control. In this study investigators will compare the occurrence of apathy in the adolescent~     Tourette syndrome population (at the UF center for movement disorders and Neurorestoration)~     to an age and gender matched control population. Investigators will also assess the role of~     commonly used medications in the Tourette population (neuroleptics and selective serotonin~     receptor inhibitors) in the occurrence of apathy.~   "
22309|NCT02765165|"~     This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a~     CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced~     solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is~     designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of~     USL311 alone and in combination with lomustine.~   "
22310|NCT02765152|"~     The purpose of this study is to verify the additional effects of rhythmic specific training,~     discrete specific training additional to conventional therapy on the upper limb after~     chronic stroke subjects on the outcomes: motor control and functionality.~   "
22311|NCT02765139|"~     The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice~     (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC).~     The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the~     International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC~     to engage men to reflect on how to reduce and prevent intimate partner violence through 16~     weekly group discussion sessions. The study is a cluster randomized control trial in which~     two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in~     15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes~     examined include: (i) Experience of past year physical, sexual and psychological violence~     reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes~     and behaviors, conflict and hostility management skills; (iii) Power sharing and~     communication within the couple.~   "
22312|NCT02765126|"~     Vaccines can have non-targeted or heterologous (also called non-specific) immunological~     effects on the immune system i.e. effects other than inducing an immune response against the~     disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological~     effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal~     influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult~     control subjects (30-50 years).~   "
22313|NCT02765113|"~     1. Background: Blepharospasm refers to orbital and periorbital orbicularis muscle~          spontaneous spasmodic contraction. Continuous spasm can be long or short, the~          performance of non spasm will strongly closed repeatedly. At present, the pathogenesis~          of blepharospasm is not clear, in addition, there is no particularly effective~          treatment.~        2. Purpose：compare two different surgical methods, observe the improvement of symptoms and~          prognosis of patients with blepharospasm.~        3. Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but~          clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open~          difficulties and the symptoms are worse when tension, anxiety, insomnia, light~          stimulation and wind outside stimulation. At the same time, in the clinic，the~          investigators found that facial nerve and trigeminal nerve combing can improve the~          clinical symptoms of the patients. Therefore, the investigators speculated that over~          activity were related to clinical symptoms and corneal reflex pathway of blepharospasm~          patients.~        4. Research content: the blepharospasm patients were randomly divided into two groups,~          prospective comparative analysis of two different surgical methods for the treatment of~          blepharospasm. One group of patients were performed facial nerve combing and~          microvascular decompression, the other group of patients were performed facial nerve,~          trigeminal nerve combing with microvascular decompression, to observation of~          postoperative clinical improvement of two groups of patients.~        5. Expected results:To define a surgical method for the treatment of blepharospasm, and to~          promote the use of the academic and clinical practice.~   "
22314|NCT02765100|"~     The purpose of this study is to better understand the relationship between bipolar disorder,~     body weight, and inflammation in the body. People with bipolar depression will be offered a~     place in a pilot study looking to see if the antibiotic minocycline added to current~     psychiatric medications has an effect on mood. A separate consent form will be provided for~     the pilot study. Numerous studies have documented the presence of altered immune function~     and elevation of inflammatory markers in patients with depression. Studies suggest that~     major depression is accompanied by immune dysregulation and activation of the inflammatory~     response system. While a small number of studies have found elevated inflammatory markers in~     bipolar mania, very little has been reported about inflammation in bipolar depression, and~     none of these studies have addressed the relationship of inflammatory markers with obesity~     in bipolar disorder.~   "
22316|NCT02765074|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of~     several cytokines, which leads to the destruction of bone and cartilage tissue in multiple~     joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard~     for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to~     detect early erosive changes and is unable to evaluate periarticular bone loss.~      High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm~     in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis~     of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the~     evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process~     and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal~     antibody, developed and investigated in several clinical trials in RA. This biotherapy, in~     association with methotrexate (MTX) or given in monotherapy, is efficient in RA with~     inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically~     systemic inflammation, structural progression and improves clinical symptoms and quality of~     life.~      Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone~     loss.~   "
22317|NCT02765061|"~     Coronary artery disease is a common medical disease in many populations. The pathogenesis of~     this disease is very complex. Surgery is one of the treatment choices. Assessing the risk~     factors will improve the surgical outcome. In this study some biochemical parameters were~     evaluated to find out the relationship between these parameters (electrolytes and albumin~     vs)~   "
22318|NCT02765048|"~     The purpose of the study is to adapt and test an evidence-based trauma treatment program for~     adolescent girls with histories of child maltreatment. The study adapts the CBITS (Cognitive~     Behavioral Intervention for Trauma in Schools) program for delivery within community-based~     settings for use with girls assessed and/or served by the child welfare system. The study~     utilizes a randomized clinical trial that evaluates the effectiveness of the adapted program~     entitled GAIN (Girls Aspiring toward Independence) compared with a usual care group. Primary~     outcomes of the intervention are mental health symptoms such as PTSD, depression, and~     internalizing and externalizing behaviors. Other outcomes include aggressive behaviors,~     revictimization, and aggression-related beliefs, self-efficacy, and behavioral intentions.~   "
22319|NCT02765035|"~     The aim of this post-market study is to confirm that the microprocessor controlled~     prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can~     bring additional benefit to the users primarily on level walking and secondarily in safety,~     stair and hill mobility, activities of daily living, satisfaction and preference.~   "
22320|NCT02765022|"~     An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure~     with clips of mucosal defects after endoscopic mucosal resection (EMR) of large~     non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.~   "
22321|NCT02765009|"~     Most ICU patients develop a positive fluid balance, mainly during the two first weeks of~     their stay. The causes are multifactorial: a reduced urine output subsequent to shock state,~     positive pressure mechanical ventilation, acute renal failure, post-operative period of~     major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable~     arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in~     relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually~     in a cumulated positive fluid balance of more than 10 litres at the end of the first week of~     stay. A high number of studies have showed that such a positive fluid balance was an~     independent factor of worse prognosis in selected populations of ICU patients: acute renal~     failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk~     surgery. However, little is known about the putative causal role of positive fluid balance~     by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a~     strategy of fluid balance control has been demonstrated to reduce time under mechanical~     ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding~     fluid overload is now recommended in ARDS management, there is no evidence that this~     approach would be beneficial in a more general population of ICU patients (i.e. with sepsis,~     acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if~     applied early could be deleterious in reducing both tissue oxygen delivery and perfusion~     pressure. There is a place for a prospective study comparing a conventional attitude based~     on liberal fluid management throughout the ICU stay with a restrictive approach aiming at~     controlling fluid balance, at least as soon as the patient circulatory status is stabilized.~     The latter approach would use a simple algorithm using fluid restriction and diuretics based~     on daily weighing, a common procedure in the ICU, probably more reliable than cumulative~     measurement of fluid movements in patients whose limits have been underlined.~   "
22322|NCT02764996|"~     This will be an exploratory observational trial of rescue acupuncture for the treatment of~     acute migraine in military beneficiaries to gain information to inform the power analysis of~     a larger, more definitive trial. Researchers do not seek to definitively answer the question~     of whether this acupuncture protocol is effective; rather, we seek to estimate the~     proportion of migraine episodes that result in headache-free status 20-30 minutes, 2 hours,~     4 hours, and 24 hours after an acupuncture treatment. Acupuncture treatments will be subject~     dependent, and points could include the N point (on scalp); various auricular points to~     include Shen Men, Point Zero, thalamus and Omega-2; body points to include Liver 2, Liver 3,~     Gall Bladder 20, bladder 10; and surface release over tense areas in the neck or shoulders.~     Researchers will document the points used, and data will be aggregated to determine overall~     effectiveness. Sub-group analysis by points will be performed to determine if there is more~     usefulness in 1 point or combination of points. These estimates will inform statistical~     power calculations for a future randomized controlled trial (RCT) that directly compares the~     effectiveness of Rescue Acupuncture with medical management of acute migraine with rescue~     medication. Researchers will also assess the feasibility of this study protocol as well as~     patient receptivity and satisfaction.~   "
22345|NCT02764697|"~     Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory~     reaction involving ocular tissue and vasculature. The inflammation usually causes pain,~     redness, photophobia and blurred vision. This inflammation, is typically treated with~     regional or systemic therapy. The regional therapy typically consists of topical~     corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a~     steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to~     evaluate the possible effectiveness of H.P. Acthar in patients with active ocular~     inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.~   "
22361|NCT02764476|"~     The purpose of this study is to design and test the safety and feasibility of virtual~     reality technologies and experiences of egocentric avatar embodiment in the application of~     physical and cognitive behavior therapy in functional neurological symptom/conversion~     disorder. Investigators hypothesize that patients will safely use and accept this modality~     of treatment and will show evidence of a decrease in symptom frequency.~   "
22323|NCT02764983|"~     Driving is a portal into general life functioning, and impaired driving skill can pose a~     serious threat to the combat veterans (CV), passengers and others; and involves increased~     risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes~     (MVC) among post deployed CV are one of the top four causes of injury and disability,~     hospitalization, and outpatient visits across the military, and are a leading cause of death~     among Army service members. The risk of motor vehicle (MV) death is significantly increased~     in years immediately following return from the battlefield. In sum, the effects of Traumatic~     Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries,~     combined with the battlefield mindset and lack of community reintegration programs place~     CV at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk~     for crash or adverse advents in this population of CV. Alternately, simulated driving~     evaluation measures driving performance in a safe, accurate and objective manner with~     evidence of absolute and relative validity when compared to real world (on-road) driving.~     Knowing participants can or cannot safely resume driving, and providing rehabilitation for~     those with a potential for resuming safe driving could result in: increased safe driving~     behaviors; avoidance of injuries, collisions, citations and participants residua; and~     resuming safe driving with its attendant benefits in the realms of family functioning,~     participation in society and satisfaction with life. The overarching objective of this~     proposal is to discern, after clinical and simulated driving performance testing , if~     Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance~     (less errors) over the short term (immediately following intervention) and intermediate term~     (3 months).~   "
22324|NCT02764970|"~     Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened~     regarding there baseline heart rate. If heart rate was > 75, patients were pretreated with~     10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart~     rate one our before CCTA was performed.~      Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and~     drug tolerance was monitored.~   "
22325|NCT02764957|"~     Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of~     developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE)~     is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily~     chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence~     over Mets components including blood pressure, blood glucose, inflammation, oxidative~     stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted~     on humans in the field of GCA influences on Mets patients. Therefore, this study is planned~     to evaluate GCA supplementation effects on anthropometric measurements, glycemic control,~     blood pressure, lipid profile, oxidative stress, systemic and vascular inflammation in~     patients with metabolic syndrome.~   "
22326|NCT02764944|"~     This study evaluates the feasibility of endo-laparoscopic full-thickness resection with~     simple suturing technique which did not expose gastric mucosa to peritoneum (simple~     non-exposure EFTR) in patients with gastric tumor.~   "
22327|NCT02764931|"~     The research aims to investigate how gluten-free oats affect the gastrointestinal health in~     celiac disease by analyzing the effects of gluten-free oats on the intestinal parameters and~     on the composition of the gut microbiota and the metabolic profile of celiac patients. The~     study is divided into two parts.~      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over~     study. Celiacs who avoid oats because of gastrointestinal symptoms will be recruited as~     subjects. The aim is to recruit 15 participants for the part 1. The study will be conducted~     with a cross-over setting, where the subjects will go through the exposure meal and~     SmartPill ingestion two times (oat and placebo) in randomized order. The study meals are~     identical in appearance and fiber content. After consuming the meal subjects will ingest the~     SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the~     external portable device. Before and during the passage of capsule the subjects will fill a~     symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected~     by the external device will be collected and analyzed. Before the oat/placebo exposure the~     subjects will give a fecal and a blood sample that will be used in part 2 to represent the~     oat-avoiding celiac group (group 1).~      In part 2 both celiacs and healthy controls will be recruited and they will be divided into~     three groups: oat-avoiding celiacs (1), oat-consuming celiacs (2) and healthy controls (3).~     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood and a~     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from~     the fecal sample, focusing especially on the amount and diversity of Bifidobacterium genus.~     The metabolic products will be analyzed from the fecal and blood sample using nuclear~     magnetic resonance analysis (NMR). The gut microbiota composition will be analyzed with~     next-generation DNA sequencing techniques.~   "
22328|NCT02764918|"~     The purpose of this study is to investigate the incidence of Cryptosporidiosis in~     Bangladeshi children and describe the acquired immune response to the pathogen as well~     investigate the potential of human genetic susceptibility.~   "
22329|NCT02764905|"~     This will be a feasibility study. Individuals that have undergone an evaluation day at the~     center for successful aging with diabetes with a Glycosylated hemoglobin (A1C) of >=7.5 and~     a Montreal Cognitive Assessment (MoCA)<26 will be approached and invited to participate. The~     participants will be divided into 2 groups: 1) information communication technology (ICT)~     group - an intervention based on weekly SMS that will remind the individual to implement his~     personal treatment plan and will raise the awareness to the importance of self-care in~     diabetes; 2) intensive cognitive-physical rehabilitation group that will include a 2 phase~     multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group~     meeting which will include computerized cognitive training, aerobic, balance and strength~     exercise and group discussion that will be dedicated to cognitive rehabilitation strategies~     development and implementation with emphasis on disease management and physical activity as~     well as psycho-education on various disease management aspects (medical and nutritional) b)~     a consolidation phase: monthly 2 hour group discussions on challenges of implementation and~     coping strategies. Outcomes will include change in A1C (primary), change in strength,~     aerobic capacity as well as quality of life and cognitive function (secondary).~     Additionally, team members and participants will fill out a structured questionnaire~     regarding their evaluation of the program aiming at refinement of the intervention.~   "
22330|NCT02764892|"~     The main purpose of the study is to identify the best dose of V81444 to use in future trials~     in patients with Parkinson's disease. The study will also explore the effects of V81444 on~     brain activity and blood flow with tests of mental ability (cognitive function tests). It~     will also check how safe V81444 is and how well it is tolerated after dosing.~   "
22331|NCT02764879|"~     The study was aimed to investigating changes in periodontal parameters and superoxide~     dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3~     FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements~     reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in~     postmenopausal women.~   "
22332|NCT02764866|"~     The study seeks to determine the prevalence of sleep disordered breathing in a population of~     patients diagnosed with lung cáncer.~   "
22393|NCT02764060|"~     The aim of this study was to examine in periodontitis patients with visible tongue coating~     the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper~     versus the use of a regular toothbrush to clean the tongue.~   "
22334|NCT02764840|"~     Resistance exercises from elastic tube has been used as part of the rehabilitation and~     maintenance of muscle tone levels in different scenarios, from disease conditions to the~     sports universe. There is the convenience and low cost of the instrument, which can provide~     impact on clinical and economic framework in case of spillage of use strategies. In a recent~     search, the investigators were not observed data on the reliability and reproducibility of a~     specific test for this tool and in this sense, it seems pertinent to undertake research on~     the topic. Objectives: To determine the reliability and reproducibility by comparison with a~     isokinetic muscle strength test located â fatigue held in elastic tube and compare the~     results of a training protocol for muscle strength gain in both methods, elastic tube and~     dynamometer. Methods: Participants will perform the muscular endurance test localized~     fatigue, on two occasions, with an interval of seven days between them. Everyone will~     accomplish so much in the elastic tube, as in the isokinetic dynamometer. It will be held~     evaluator analysis intra and inter evaluator. After first stage of the study to determine~     the reliability test, the participants will undergo three weeks of training to gain muscular~     endurance, distributed in two groups G1 (training in the elastic tube) and G2 (training in~     isokinetic dynamometer) previously randomized. It will use the intra-class correlation~     coefficient with 95% confidence interval to check the repeatability and the Kappa~     coefficient with 95% confidence interval for reproducibility. To compare the responses of~     training, the distribution will be made as to the normality of the data by the~     Kolmogorov-Smirnov test. In the case of normal distribution, the Student's t-test for~     unpaired data and Mann-Whitney will be adopted if there is no normal distribution.~   "
22335|NCT02764827|"~     Pollen allergen extracts are prepared locally and checked for efficacy by comparison to~     imported allergens and specific IgE.~   "
22336|NCT02764814|"~     Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional~     treatment in patients with moderate to severe Dry Eye Disease (DED)~   "
22337|NCT02764801|"~     The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and~     4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE)~     response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced~     magnetic resonance (MRI) or computed tomography (CT) imaging~   "
22338|NCT02764788|"~     Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one~     of the most frequent causes of referral to the pain management unit. It affects mainly~     women; they are referred by a rheumatologist, an internal medicine physician or by their~     family physician.~      FM produces various degrees of disability and pain, and has an important impact on quality~     of life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the~     clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack~     of efficacy of pharmacological treatments make management of FM a very difficult task. In~     France the consensus includes limitation of pharmacological treatment, encouraging physical~     rehabilitation and referring the patients to a specialized pain clinic where~     multidisciplinary management will be undertaken. In our hospital the investigators favor non~     pharmacological therapies and propose to the FM patients to learn relaxation and~     self-hypnosis, physical rehabilitation and use of trans cutaneous electrical~     neurostimulation.~      Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a~     microsystem which reflects the entire body, represented on the auricle, the outer portion of~     the ear. Mapping of the auricle has been described, according to the fact that pathology of~     different organs can induce specific changes in the auricle, for example color change or~     sensitivity. Treating specific areas, which somehow would be connected to the affected~     organ could also improve the functioning of the body or relieve pain. AT uses placement of~     needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the~     effectiveness of ATis currently supported by randomized controlled trials. It is validated~     by WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.~      The investigators regularly use AT in FM patients in our pain management unit to alleviate~     symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial~     in this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire)~     following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and~     depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The~     remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same~     tests.~   "
22339|NCT02764775|"~     Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive~     diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization,~     surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum~     of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the~     Headpod. Video will be taken to document changes.~   "
22340|NCT02764762|"~     The purpose of this study is to determine the effect of triple combination therapy with an~     anti-integrin [vedolizumab intravenous (IV)], a tumor necrosis factor (TNF) antagonist~     [adalimumab subcutaneously (SC)], and an immunomodulator (oral methotrexate) on endoscopic~     remission in participants with newly-diagnosed Crohn's disease stratified at higher risk for~     complications.~   "
22341|NCT02764749|"~     Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as~     cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced~     cholesterol and decreased cardiovascular risk. Cranberries are a rich source of~     (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether~     cranberries can improve vascular function when given over relevant time periods and in~     relevant populations is not known. Therefore, it is the overall hypothesis of the study~     proposal that chronic consumption of cranberries can improve endothelial function, a~     prognostically validated surrogate of cardiovascular risk. This study also aims to reveal~     which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma~     and urine metabolite peaks will be correlated with vascular outcomes and genome-wide~     expression microarrays will be performed to reveal cell signaling pathways associated with~     cranberry (poly)phenol-mediated cardioprotective events.~   "
22342|NCT02764736|"~     The specific aim of this trial is to determine whether initiating moderate- or~     high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin~     reduces inflammation and lowers average Epogen utilization. Statin naive patients on~     maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to~     40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers~     (ferritin, CRP) and weekly Epogen usage will be monitored.~   "
22343|NCT02764723|"~     The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with~     isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing~     lower limb orthopedic surgery.~   "
22344|NCT02764710|"~     The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and~     augmentation surgery is unknown. This is a comparative open label interventional trial~     comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate~     with short antibiotic treatment for up to 24 hours postoperatively. The primary study~     outcome is the postoperative surgical site infection in the standard versus the short~     treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile~     infection.~   "
22394|NCT02764047|"~     Evaluate the effect of supplementation of probiotics on liver changes (histological and~     enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis~     (NASH).~   "
23611|NCT02748135|"~     The purpose of this study is to assess the safety and tolerability profile of TB-403~     (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects~     with relapsed or refractory Medulloblastoma.~   "
22346|NCT02764684|"~     Objective:~      In this study the investigators aim at investigating:~        1. probiotics ability to modulate the microbiome and microbial translocation,~        2. if probiotics affect the level of cholesterol, triglycerides as markers of~          cardiovascular risk factors and~        3. if a reduction of microbial translocation is associated with a reduction of~          inflammation in the gastro-intestinal tract.~      Design:~      The study is a prospective clinical intervention trial of 40 HIV-infected patients.~      Method:~      The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to~     each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention,~     the investigators will collect blood samples, feces samples and make a positron emission~     tomography-magnetic resonance scans.~   "
22347|NCT02764671|"~     The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml~     Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.~   "
22348|NCT02764658|"~     The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a~     biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than~     CRP for confirming COPD severity and acute exacerbation frequency. It was related to the~     1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an~     immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in~     mice. Previous report showed that voluntary wheel running and fluid flow shear stress that~     promote the expression of the Prg4 and association with pulmonary inflammation. COPD~     patients are characterized by a progressive decrease of lung function that is associated~     with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to~     decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and~     improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The~     current study aimed to study in the pulmonary inflammation and the effectiveness of~     pulmonary recovery in COPD Patients：The mechanism of PRG 4.~   "
22349|NCT02764645|"~     This is a single center, prospective study:~      The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the~     control group.~   "
22350|NCT02764632|"~     Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing~     experience. Many techniques have been explained to improve success rate along with~     increasing safety, such as forward displacement of the larynx, tube rigidity improvement~     methods, pushing it down directly through pharynx or using a guide tube. Failure of~     insertion under general anesthesia reached 50% in some publications~   "
22351|NCT02764619|"~     A randomized, double-blinded, placebo-controlled study to evaluate the effect of~     spironolactone in addition to conventional treatment compared with placebo in patients with~     paroxysmal and persistent atrial fibrillation with preserved left ventricular ejection~     fraction by T1 mapping, structure and function of left atrium and ventricle assessed by~     transthoracic echocardiography and cardiac magnetic resonance (CMR), the number of recurrent~     episodes of atrial fibrillation and biomarkers measured in blood.~   "
22352|NCT02764606|"~     CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the~     value of new serum markers to predict the occurrence of metastases in patients with~     early-stage non-small cell lung cancer. This would represent a rational to develop~     personalized follow-up and prevention strategies~   "
22353|NCT02764593|"~     This phase III trial with a phase I dose finding lead-in study will evaluate whether the~     addition of nivolumab will improve the overall survival for patients with newly diagnosed~     intermediate-risk or high-risk Head and Neck Squamous Cell Carcinoma (HNSCC) when treated~     with radiation therapy and cisplatin-based or cetuximab-based chemotherapy or with radiation~     alone.~   "
22354|NCT02764567|"~     Lab sampling for clinical trial participants can be a stressful and painful experience. Most~     trial participants will have blood drawn for lab samples at multiple study visits. The~     participants must fast for up to ten hours before the blood sampling, in many cases, and~     patients often report a painful experience if more than one venipuncture occurs. In~     addition, the number of collection tubes can increase the anxiety level of the patient and~     the phlebotomist.~      This project proposes to evaluate if essential oil aromatherapy results in less pain and /or~     anxiety when compared to usual care.~   "
22355|NCT02764554|"~     The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of~     Lenvima (lenvatinib) in normal clinical practice setting.~   "
22356|NCT02764541|"~     This research study is evaluating how well Breast Cancer responds to preoperative treatment~     with Endocrine treatment in combination with a drug called Palbociclib or Endocrine~     treatment alone as possible treatments for Hormone Receptor Positive Breast Cancer.~   "
22357|NCT02764528|"~     The purpose of the handwashing intervention trial is to determine whether an interactive,~     storytelling approach to promoting handwashing with soap by health care workers can improve~     mothers' handwashing behavior during the first month of her child's life.~   "
22358|NCT02764515|"~     This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial~     aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese~     traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid~     arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate~     both in efficacy and safety.~   "
22359|NCT02764502|"~     Introduction Several attempts have been made to improve or facilitate epidural space~     detection beside conventional loss of resistant technique. Recently many sophisticated~     equipment's and techniques have been described which did not received widespread popularity.~      Objectives The Investigator describes and assesses the validity of using Pressure Gauge~     Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.~      Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the~     interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the~     hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml~     syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between~     manometer and the tip of epidural needle , the needle is advanced slowly using both hands~     while monitoring the manometer reading and is stopped when the pressure suddenly dropped (~     the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural~     space ).~   "
23645|NCT02747680|"~     This research study is designed to investigate the effect of hypoglycemia (low blood sugar)~     on blood flow to and biochemistry in the brain.~   "
22362|NCT02764463|"~     This prospective clinical study evaluated the performance of indirect, posterior~     occlusal-retained, fiber-reinforced-composite restorations.~      Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62~     years old ( 33 male, 25 female) received 65 FCRFPD prosthesis.~      All restorations were made indirectly on a plaster model using unidirectional E-glass fibers~     (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite~     (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement~     Variolink II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6~     months and thereafter annually up to 15 years. The evaluation protocol involved technical~     (chipping, debonding or fracture of tooth/restoration) and biological failures (caries).~   "
22363|NCT02764450|"~     This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I~     and Class II restorations made of microhybrid composite and applied using two polymerisation~     protocols,~   "
22364|NCT02764437|"~     The investigators have identified areas of the brain that are activated in response to~     disease-related emotional information, following whole lung allergen challenge in asthma.~     They propose that activity in these central nervous system locations, as measured by fMRI,~     is associated with the intensity of allergic inflammation, provoked by segmental bronchial~     challenge, in the absence of significant airflow obstruction. The investigators predict that~     this relationship will be mediated by changes in expression of genes in the IL-1β/IL-17~     pathway.~   "
22365|NCT02764424|"~     Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures~     is a daily and essential concern for the caregiver neonatologist. The quantification of pain~     is needed to effectively adjust analgesic therapy and by the way, to limit side effects.~     Several pain scales are now validated for newborns but they are based on one-off measures~     and hetero assessments often dependent on many factors including the operator.~      Recent developments in the real time analysis of the cardiac signal under the influence of~     autonomic control, have led to the development of a new painful stress index. A monitor has~     recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index~     (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic~     Evaluation - in newborns). It is based on the study of the heart rate variability and the~     variations of the sympathetic and parasympathetic indices to stimuli. The validation of this~     nociception index has not been validated in a neonatal unit where special attention is paid~     to pain control.~      The main purpose of our study is to show the consistency of this NIPE index (adapted to~     newborns) from 2 validated pain scales routinely used in neonatology in non-sedated~     children, hospitalized in intensive unit and neonatal intensive care unit from the~     University Hospital of Saint-Etienne (France).~      The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26~     and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units~     of our university hospital (Saint-Etienne - France), who have to acute painful stimuli~     related to their care.~   "
22366|NCT02764411|"~     Capillary Malformations (CM) affect a significant proportion of otherwise healthy children~     and may lead to psychological discomfort if left untreated. A significant proportion of~     untreated lesions undergo soft tissue thickening and darker discoloration later in life due~     to progressive ectasia of the affected vessels. While laser treatment is available, its use~     may be limited due to need for repeated sedation/general anesthetic use, partial response~     and cost.~      The investigators propose to conduct an open-label, prospective, cohort study using Onreltea~     ( Brimonidine) gel for treatment of facial capillary malformations in children. The study~     medication will be applied topically on affected area of the skin daily for 12 weeks. Follow~     up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the~     proposed treatment.~      The study second aim is to explore the feasibility of conducting a multicenter placebo~     controlled study.~   "
22367|NCT02764398|"~     Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective~     ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains~     unclear but may be attributed to an autonomic nervous reflex induced by catheterization of~     the ophthalmic artery. The investigators hypothesize that inadequacy between depth of~     anesthesia and catheter stimulation might be a support cause of these SCRE.~      Methods: Children requiring super selective ophthalmic artery chemotherapy for~     retinoblastoma are prospectively included in this observational study. Endovascular~     procedures are performed under standardized and deep general anesthesia with sevoflurane,~     sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension,~     bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence~     are investigated.~   "
22368|NCT02764385|"~     This study will compare the effectiveness of two approaches for delivering smoking cessation~     advice in the primary care setting. Ask-Advise-Connect (AAC) is a strategy that uses the~     electronic health record (EHR) to prompt clinical staff to Ask if the patient smokes, Advise~     them to quit and, if they're interested, Connect them to Quitline (QL) counseling services.~     The connection occurs when a QL counselor is notified of the patient's interest, and then~     calls the patient to enroll in treatment. AAC has been shown to be very effective at~     enrolling patients, however, it was found that less than 42% of patients who agreed to be~     referred were successfully contacted by the QL after 5 call attempts. This indicates that~     many patients that are referred are not ready for cessation, but may feel obligated to~     accept the referral from their primary care team. This presents an opportunity to improve~     the patient centeredness of the referral process.~      To overcome these limitations, the investigators propose pairing it with a patient-centered~     smoking cessation approach called the Teachable Moments Communication Process (TMCP). The~     investigators' team developed this communication strategy, which incorporates patients'~     concerns into a partnership-oriented discussion about smoking cessation. The investigators~     propose that combining these two approaches could increase appropriate referrals to the QL,~     increase the likelihood of successful patient contact and enrollment, and increase the~     patient's rating of the value of the experience.~   "
22548|NCT02762032|"~     This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin~     microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1~     of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo~     (control) to take twice daily for 14 weeks.~   "
22369|NCT02764372|"~     The aims of the present study were to:~        -  Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on~          Kinect, to augment upper extremity neurorehabilitation services.~        -  Provide preliminary evidence of clinical efficacy of the approach in increasing arm~          activity and health related quality of life of persons post stroke or with MS.~      Main results suggest that the serious games approach was positively received in terms of~     user experience and motivation to use, with the participants showing also improvements in~     functional abilities of the treated arm.~   "
22370|NCT02764359|"~     Obesity alters the movement through the body of several antibiotics, including vancomycin.~     Based on literature to date, total body weight should be used to determine dosages and~     shorter dosing intervals may be needed. However, hospitals have different approaches to~     managing vancomycin in this patient population. The most common example is not exceeding a~     dose of 2,000mg of vancomycin at one time in these patients. However, some institutions~     including the Charleston Area Medical Center do not have a set maximum one time dose. To~     date, a study has not been done comparing two different dosing regimens in obese patients to~     determine if having a maximum dose cap is beneficial.~      This research study is attempting to add to the limited existing body of literature~     regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing~     the initial or loading vancomycin dose that obese patients receive will decrease the time to~     target concentrations. For this study, obese adult patients will be randomized to receive~     either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose~     of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine~     differences in the time needed to achieve target vancomycin concentrations and the~     occurrence of adverse events.~   "
22371|NCT02764346|"~     This study will look at the use and impact of smartphone application (app) for adolescents~     with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project~     will include three studies. First, the investigators conducted usability sessions with~     adolescents with JIA to refine the app so that it is usable, acceptable and understandable.~     The aim of this study is to look at (a) how regularly the iCanCope with Pain app is used~     and (b) any effect the app has on young people's health. This study will compare two groups~     of young people: one that is using the new app, and one that receives usual medical care.~   "
22372|NCT02764333|"~     This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1~     (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor~     alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help~     un-block parts of the immune system. The aim of this study is to find out whether these~     drugs, when given together are safe, and whether they are effective in treating cancer.~   "
22373|NCT02764320|"~     There are two commonly used treatment strategies for treating patients who have chronic~     migraine with medication overuse. This study will compare the outcomes amongst patients~     randomized to one of the two treatment strategies.~   "
22374|NCT02764307|"~     Background: Nebulizers design influences efficiency of aerosol delivery. Performance of~     nebulizers is commonly tested by breathing simulators with static parameters. However,~     breathing patterns vary in adults.~      Objectives: The purpose of this study was to evaluate drug deposition of different types of~     nebulizers testing with breathing patterns of healthy subjects.~   "
22375|NCT02764294|"~     Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction~     before and during the procedure. Especially male patients feel more pain than females during~     cystoscopy. The aim of this study is to compare effectiveness of three different distraction~     methods on pain, anxiety and satisfaction of the male patients during cystoscopy.~   "
22376|NCT02764281|"~     The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide,~     pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell~     transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell~     lymphoma, nasal type.~   "
22377|NCT02764268|"~     Apatinib dose titration in Advanced or Metastatic Gastric Cancer~   "
22378|NCT02764255|"~     cases with embyos cultured in the standard incubator and evaluated only by morphology~     (control group) are compared to cases with embryos continuously monitored by the embryoscope~     followed by embryo selection based on a multivariable model(study group)~   "
22379|NCT02764242|"~     Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are~     important but false positive by crossreactivity can occur. sIgE to recombinant venom~     allergen is proposed to help in finding the causative insect.~   "
22380|NCT02764229|"~     The purpose of this study is to allow subjects completing study LYC-30937-2001 the~     opportunity to receive LYC-30937-EC 25 mg.~   "
22381|NCT02764216|"~     The optimal treatment of HNCUP remains controversial and lacks evidence from prospective~     randomized trials. The management of these patients relies primarily on surgery and~     radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains~     controversial. The main debate concerns the extent of the radiation field. Although~     pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes~     reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been~     associated with significant toxicity and long-term morbidity (mostly xerostomia and~     dysphagia). Most single institution retrospective studies have not shown any advantage for~     more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate~     only for these patients.~   "
22382|NCT02764203|"~     The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on~     blood pressure and compare outcome data derived from wearable/digital health devices to data~     derived from standard methods. Additionally, the usability of the wearable technology will~     be evaluated.~   "
22444|NCT02763397|"~     The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which~     aims to treat motor symptoms by a high-frequency stimulation, will be temporarily~     reprogramed to stimulate the NbM at a low frequency using the distal electrodes positioned~     in the vicinity of the NBM.~      This study aims to investigate the neuropsychological effect of low frequency stimulation of~     the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were~     previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).~   "
22383|NCT02764190|"~     Adolescents have some of the highest rates of risk behaviors of all age groups and health~     behaviors developed in adolescence can persist into adulthood. These behaviors carry~     significant risks for subsequent disease, disability, and healthcare burden. Despite these~     risks, health risk screening in primary care is infrequently performed and results are~     rarely followed by targeted intervention. In response to the need for screening-linked~     interventions, our study team has developed a web-based, electronic Personalized~     Motivational Feedback tool which we refer to as Check Yourself. Based on motivational~     interviewing, a technique to mobilize personal change, Check Yourself is designed to promote~     healthy choices for the multiple behaviors relevant to adolescents as well as to provide~     information to providers to promote discussions around health behaviors between providers~     and adolescents.~      Building on electronic health interventions, primary care providers can play an essential~     role in helping adolescents to make healthy behavior choices. Emerging evidence suggests~     that the consistency of preventive counseling can be increased through provider training and~     the provision of screening tools; yet, we know very little about the quality of such~     counseling, and if it impacts outcomes that are important to adolescent patients themselves.~      This study is a stepped-wedge, controlled trial comparing the effectiveness of an~     interactive adolescent-centered training for primary care providers (I-ACT) and Check~     Yourself to usual care. This study will take place in six pediatric practices. The purpose~     of this study is to determine whether this system of interventions (i.e., I-ACT, Check~     Yourself, and the summary report) is more effective than usual care in reducing health risk~     behaviors, improving adolescent motivation for health, and improving quality of care among~     adolescents receiving primary health care services.~   "
22384|NCT02764177|"~     Whilst the effects of manipulating the macronutrient content of foods on appetite and energy~     intake has been relatively well studied at rest, little is known about these responses in a~     post-exercise context. The effect of post-exercise nutrition on recovery from or adaptation~     to exercise has been well studied. However, many exercisers do so for weight management and~     thus any post-exercise nutrition might impact on energy balance and might need to be~     carefully considered. This study will examine the impact of manipulating the composition of~     a recovery drink consumed after resistance exercise on subsequent appetite and energy~     intake.~   "
22385|NCT02764164|"~     Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory~     hallucinations after one week of twice daily treatment with transcranial direct current~     stimulation (tDCS).~   "
22386|NCT02764151|"~     This study will evaluate the safety and tolerability of increases doses of PF-06840003 in~     patients with malignant gliomas.~   "
22387|NCT02764138|"~     Racial and socioeconomic disparities in physical and mental health problems are large,~     persistent, and severe; begin during childhood; and stem from in part damage to physiologic~     stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt~     this progression of damage to a child's stress response system may offer new directions for~     combatting health disparities. This project will evaluate the efficacy of a new prevention~     program designed to teach preadolescent children effective ways for coping with chronic~     stress that will have direct effects on their physiologic stress response systems~     (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression,~     and post-traumatic stress symptoms and disorders.~   "
22388|NCT02764125|"~     This will be a randomised, crossover, double-blind, double-dummy, active-controlled,~     multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with~     end-of-dose wearing-off (motor fluctuations).~   "
22389|NCT02764112|"~     ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara,~     James Hoehns, Matthew Witry~      The international normalized ratio (INR) is the accepted lab test used to measure the~     intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin~     are unable to correctly determine, in the absence of an INR result, whether or not they are~     therapeutic at any given time. Some warfarin treated patients express that they have insight~     into what their INR result will be. Various patient related factors may contribute to these~     opinions.~      Our objective is to assess how accurately patients can guess their INR result before it is~     obtained and to describe factors which inform their opinion of what their INR will be.~   "
22390|NCT02764099|"~     The proposed research is designed to adapt and test an evidence-based drug abuse prevention~     approach for use in youth courts among first-time, non-violent, adolescent offenders. The~     ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug~     abuse, violence, and delinquency. Planned project activities include conducting: 1) key~     informant interviews of youth court directors regarding logistical and intervention features~     of effective youth court programming; and, 2) a randomized controlled efficacy trial of an~     adapted version of Life Skills Training, an evidence-based drug and violence prevention~     program. It is anticipated that the findings will provide critical information on~     implementing evidence-based prevention programs for new populations and settings and will~     support preparations for a large-scale effectiveness trial in youth peer courts.~   "
22391|NCT02764086|"~     This is a prospective non-randomised Phase I/II study with patients recruited to escalated~     dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the~     conventional PTV (planning target volume), will be delivered to successive cohorts of~     participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is~     determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation~     therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity~     Projection (AVIP) dataset.~      Standard of care chemotherapy. In the initial part of this study patients can receive either~     neo-adjuvant chemotherapy or no chemotherapy at all.~      Following initial toxicity evaluation, the study will be extended to include a concurrent~     chemotherapy arm.~   "
22392|NCT02764073|"~     Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and~     mortality remains substantially high worldwide. Pulmonary congestion is considered the~     leading cause for hospital admissions and death among patients with HF. Physical examination~     is crucial for titrating medical treatment in these patients, but despite a good specificity~     it is not sensitive enough to detect early elevated cardiac filling pressures.~      The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor~     for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new~     relevant biomarkers for HF evaluation.~      Echocardiography can be also used to noninvasively measure left ventricular filling~     pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently~     proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines~     correlate with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after~     a stress test. LUS can also identify clinically silent pulmonary edema, suggesting that it~     may complement clinical evaluation to improve hemodynamic profiling and treatment~     optimization.~      Biompedance is a bedside method for total body fluid status assessment. It defines~     individual fluid status/compartments/overload on the basis of an individual's normal~     extracellular volume and body composition. Recent studies indicate that bioimpedance-derived~     fluid overload indices are independent predictors of mortality in renal failure patients.~      To date, no study has evaluated bioimpedance performance for fluid assessment in HF~     patients. The investigators aim to cross-sectionally compare bioimpedance parameters with~     clinical evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a~     cohort of incident consecutive patients with HF. Two years patients' survival will be~     evaluated to propose the best evaluative algorithm and rank the various methods for~     prognostic significance.~   "
22395|NCT02764034|"~     The human endometrium is an extremely sensitive target. LLLT can enhance the proliferation~     rate of various cell lines, it produces higher rates of ATP, RNA, and DNA synthesis in stem~     cells and other cell lines. Thus, LLLT improves the proliferation of the cells without~     causing any cytotoxic effects.~      The aim of this work is to assess the ability of low level laser therapy in enhancing~     endometrial proliferation and increasing endometrial receptivity.~      A number of 120 human endometrial samples will be studied, and will be collected from 40~     infertile women attending the infertility clinic at NRC. Each human endometrial sample will~     be divided into 3 plates, in order to establish 3 main groups of 40 culture plates for~     single laser exposure group versus 40 culture plates for multiple laser exposure group and~     40 tissue culture plates for control samples, thus a total of 120 tissue culture plates will~     be studied, the study groups will be exposed to low level laser therapy and compared to~     their matched controls.. Assessment of number and size of cells after LLLT as a marker of~     normal proliferation and b) The expression of Integrin aVB3 alpha v B3, MUC-1 and LIFand~     the development of pinopodes on the surface of epithelial cells as markers of endometrial~     receptivity and the detection of PTEN tumor suppressor gene as a marker of abnormal~     proliferation or premalignant condition will be performed to assess the effect of LLLT on~     the endometrial cell culture. This study might offer a new therapeutic modality which might~     increase endometrial thickness and enhance receptivity .~   "
22396|NCT02764021|"~     Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient. The~     study group hypothesizes that a lower carbohydrate content in the diabetic diet than the~     recommended 55 energy percentage (E%) will decrease the postprandial glucose excursion. This~     will reduce postprandial insulin concentration, which together with lower glucose~     concentration leads to less fat accumulation in the liver and muscle tissue, resulting in an~     improved insulin sensitivity which together with a reduced glucose load improves the glucose~     metabolism. This clinical study will examine in subjects with type 2 diabetes the effect of~     highly controlled dietary low carbohydrate intervention on metabolic pathways with respect~     to insulin action, pancreatic islet function, lipid metabolism, ectopic fat accumulation,~     incretin hormones, low grade inflammation in plasma and adipose tissue, novel measures of~     fatty acid metabolism, and heart rate variability, respectively. The studies exhibit the~     potential to reform dietary recommendation aiming to prevent and ameliorate type 2 diabetes.~   "
22397|NCT02764008|"~     Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the~     standard treatment for large and complex renal stones. Although it has lower complication~     and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube~     can cause distress for patients.~      Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation,~     which defeat the purpose of this minimally invasive procedure.~      Skin infiltration with bupivacaine around the nephrostomy tube is not effective.~     Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy~     tube, suggesting the role of renal capsule in pain management.~      Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy~     tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block~     offers the option of providing extendable perioperative pain relief without the above side~     effects or the physiologic derangement associated with local anesthetics in the central~     neuraxial space.~      The aim of this study is to determine whether ultrasound guided low thoracic paravertebral~     block effective post-operative analgesia as compared to peritubal infiltration analgesia in~     patients undergoing percutaneous nephrolithotomy.~      Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary~     endpoints are visual analogue pain scores, opioid related side effects.~   "
22398|NCT02763995|"~     Cardiovascular diseases (CVD) are the main cause of death in Spain. In HIV patients, the~     uncontrolled viral replication, antiretroviral therapy (ART) and coinfections contribute to~     develop metabolic diseases and increase the prevalence of risk factors for CVD. These~     patients are aging which results in a higher probability of comorbidities, increased number~     of medications, possibility of having a negative outcome associated with medication (NOM)~     and increased cardiovascular risk (CVR). Various studies have established that~     pharmaceutical care (PC) results in better control of cardiovascular risk factors.~      The purpose of this study is to evaluate the impact of pharmaceutical care achieved through~     pharmacotherapy follow-up on cardiovascular risk and health related quality of life (HRQoL)~     of HIV patients older than 50.~   "
22399|NCT02763982|"~     The purpose of this study is to determine whether ejection fraction and peak oxygen uptake~     have correlation on inspiratory muscle strength, chest wall volumes and quality of life in~     individuals with heart failure.~   "
22400|NCT02763969|"~     The purpose of this study is to establish if BMS-986202 is safe and effective at treating~     autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in~     preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will~     be the first time this drug is given to humans.~   "
22401|NCT02763956|"~     Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to~     10-15 % of adults. The purpose of this study is to evaluate the efficacy of treatment with~     the GelStix™ device in a patient population with discogenic pain that had no benefit from~     conservative care.~   "
22408|NCT02763865|"~     The purpose of this study is to determine the effects of Low Frequency Repetitive~     Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA)~     on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor~     (ET).~      Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the~     TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the~     pre-SMA effects tremor in patients with ET.~      Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing~     pre-SMA output, and improving motor control, as determined shortening of the delay in the~     second agonist burst, seen in ET patients. At conclusion of this study expect to have~     sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of~     pre-SMA r-TMS in ET.~   "
22409|NCT02763852|"~     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA~     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4~     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of~     standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy~     volunteers.~   "
22402|NCT02763943|"~     There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk~     factor control on graft survival disparities in Black transplant recipients. Studies in the~     general population indicate that CVD risk factor control is poor in Black patients, leading~     to higher rates of renal failure and CV events. However, with the exception of hypertension,~     there is paucity in data demonstrating similar results within transplant recipients. Recent~     analyses conducted within our transplant program, indicate that CVD risk factors, especially~     diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since~     these data were collected in a retrospective manner, larger analyses are needed to validate~     these exploratory findings.~      This pilot study is to:~        1. Determine if the study is feasible, as measured by the proportions of enrolled to~          approached and completed to enrolled.~        2. Measure and compare, at baseline versus the end of the intervention, the medication~          safety events, including the number of medication errors, medication non-adherence and~          medication side effects, in patients enrolled in the study~        3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor~          control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the~          study~        4. Measure and compare, at baseline versus the end of the intervention, patient reported~          survey results, in patients enrolled in the study~        5. Determine if the impact of the intervention is more pronounced in Black recipients, as~          compared to non-Black recipients~   "
22403|NCT02763930|"~     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese~     consumption, with potentially important impact on this key industry in Canada. This is in~     part due to the commonly accepted notion that saturated fat in the diet, of which cheese~     contributes significantly, increases the risk of heart disease. Yet, a rather large body of~     recent evidence suggests that saturated fat may have been unfairly demonized and that its~     impact on the risk of heart disease may in fact be less important than originally thought.~     This concept that dairy fat increases the risk of heart attacks therefore needs to be~     revisited.~      The proposed research is designed to investigate which risk factors for heart disease (e.g.~     cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat~     (cheese) dairy products are consumed.~      Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a~     dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces~     inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a~     dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable~     effects on LDL particle size, inflammation and HDL-C concentration.~   "
22404|NCT02763917|"~     Background: Asthma and obesity are public health crises that have concurrently risen over~     the past decades, affecting millions of children in the United States and disproportionately~     affecting low-income minority children in urban areas. The same children at highest risk for~     asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging~     evidence suggests that obesity may confer increased susceptibility to health effects of air~     pollution.~      Methods: Aiming to provide causal-level evidence of these observational findings, we propose~     a home intervention study to 1) test whether targeted reductions of indoor Particulate~     Matter (PM) concentrations improve the respiratory health of overweight inner-city children~     with asthma more than that of lean inner-city children with asthma and 2) investigate~     mediators of susceptibility to indoor PM among overweight versus lean children with asthma.~     We will accomplish these aims using a 1:1 randomized controlled trial of 200 children with~     persistent asthma (half normal weight, half overweight) living in Baltimore City.~     Participants will be randomized to receive either two active air purifiers containing~     high-efficiency particulate air (HEPA) filters or two sham air purifiers with their filters~     removed.~      Implications: If the aforementioned observational findings are confirmed, implications will~     be directly relevant to the over 170 million children around the world now estimated to be~     overweight or obese.~   "
22405|NCT02763904|"~     Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is~     evidence that the nutritional status may influence the response to drug treatment,~     mortality, susceptibility to infections, the patient's functional status, duration of~     hospital stay and, consequently, overall healthcare costs. The causes of malnutrition are~     manifold. The underlying disease may in fact lead to an increase in the patient's energy~     needs, whether or not associated with a reduction in caloric intake. The same therapeutic~     treatments can further worsen the energy balance without considering that the patient can be~     kept fasting for the execution of some diagnostic procedures. Therefore, a further~     deterioration of nutritional status during hospitalization could occur.~      International guidelines underline the utility to set a nutritional support whenever this is~     necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In~     this perspective, the improvement of oral diet and the use of oral nutritional supplements~     (ONS) represent the first-line strategy of intervention. Previous studies have shown that~     nutritional counseling, with or without the use of ONS, in patients with chronic disease is~     able to improve the calorie-protein intake, prevent deterioration of nutritional status, as~     well as to increase to a certain extent body weight. Particularly, energy-dense are more~     effective in increase energy intake. These data have highlighted the importance of a proper~     evaluation of the nutritional status of early detection of patients who could benefit of~     nutritional support. However, the independent role of the ONS in improving clinical outcome~     still needs to be established.~   "
22406|NCT02763891|"~     This study evaluates the effect of body suspension and tilting exercises (performed in~     Chordata apparatus) on the balance and mobility of subjects with Parkinson disease. Half of~     patients will perform the exercise protocol while the other half will receive passive muscle~     stretching and maintain the usual routine.~   "
22407|NCT02763878|"~     The investigators intend to conduct multi-center randomized controlled study to find if~     Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can~     reduce the long-term complications, affect the quality of life, and improve the prognosis,~     comparing to Billroth II anastomosis.~   "
22410|NCT02763839|"~     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA~     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4~     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of~     standard levodopa 100 mg/carbidopa 25 mg (Sinemet® 25/100) in adult male and female healthy~     volunteers.~   "
22413|NCT02763800|"~     The objectives as stated in the study protocol were as follows:~        -  To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202~          (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male~          volunteers). Part A~        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA~          3-202 in healthy young males. Part A~        -  To investigate the safety and tolerability of a single multiple dose regimen (dose to~          be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B~        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of a~          single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in~          healthy elderly volunteers. Part B~   "
22414|NCT02763787|"~     The purpose of this study is to investigate the safety and tolerability of single oral~     rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg,~     400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the~     preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult~     subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human~     erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose~     of BIA 3-202.~   "
22415|NCT02763774|"~     This study aims to analyze effects of three types of cardiac rehabilitation protocol on~     fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after~     coronary artery bypass grafting (CABG) in patients with left ventricular disfunction.~     Patients will be randomized and allocated in three groups according to type of exercise~     protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.~   "
22416|NCT02763761|"~     The purpose of this study is to compare the effects of Infliximab and oral prednisone with~     methylprednisolone and oral prednisone in immune related Grade 3-4 diarrhea (≤ 3 days) or~     persistent Grade 2 diarrhea (> 5 days) patients who received chemotherapy with Yervoy and/or~     Opdivo~   "
22417|NCT02763748|"~     Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation~     potential, the incidence increased year by year. The surgical resection is the primary~     treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of~     the delicate sense of touch, it could lead to the incomplete resection and disorders of~     digestion. More than 33% of postoperative patients have the gastric dysfunction.~     Laparoscopic endoscopy combined surgery is different from the past technology. It is a new~     radical resection of GIST presented by Japanese scholars. LECS resects the tumor completely~     by laparoscopy with the help of the precise positioning and guidance of endoscopy .This~     method conforms to the idea of the modern minimally invasive surgery, and avoids many~     problems，such as incomplete resection and disorders of digestion caused by excessive tissue~     resection. our team will spearhead the GIST treatment of LECS. First of all, the~     investigators will collect 120 cases of GIST patients, randomly assigned for the~     laparoscopic group, the LECS, single-arch the LECS surgical treatment. Secondly, to~     analyzing the basic treatment and follow-up data, including the operation time, blood loss,~     the number of transfer laparotomy, the number of cut edge positive, the distances of cut~     edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average~     such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of~     residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and~     other indicators.The purpose of this subject is to observe the effectivity and safety of~     LECS and single-arch the LECS, invent serval LECS equipment patents and provide some~     references for LECS applying to the minimally invasive surgery of the digestive tract tumor~     and multidisciplinary treatment mode .~   "
22418|NCT02763735|"~     The purpose of this study is to use non-invasive imaging to determine the metabolic~     phenotype of the right ventricle in patients with pulmonary arterial hypertension across a~     spectrum of disease severity.~   "
22419|NCT02763722|"~     Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease that has potential~     for profound and far-reaching effects on all aspects of children and their families lives,~     significantly reducing the quality of life. Atopic dermatitis typically appears in infancy~     and nowadays is affecting up to 10-30% of children and 2-10% of adults.~      Diminished skin barrier is the essential factor that plays a role in the initiation,~     consolidating and exacerbating AD. Treatment options for AD typically address skin barrier~     protection or inflammatory components of disease. Proper care using mild and appropriately~     formulated emollient preparations may provide significant benefits.~      In investigators prior study, more than half of pharmacy-derived emollient preparations~     contained potential contact haptens listed in the European baseline series (EBS), used in~     diagnosing contact dermatitis.~      The primary aim of this study is to demonstrate the efficacy of regularly applied emollient~     in an atomiser (in the form of oil-in-water emulsion) in maintenance therapy, in children~     presenting from mild to moderate atopic dermatitis.~      In this study 3 visits are planned (for a period of 4 weeks). During each visit~     investigators will evaluate transepidermal water loss (TEWL), capacitance of outer areas of~     the stratum corneum as an indirect assessment of skin hydration. Moreover, investigators~     will assess three-them-severityIndex and the Children's Dermatology Life Quality Index~     (CDLQI).~      The product that participants will use in the study, was prepared at investigators request,~     in collaboration with the cosmetics company, which according to investigators knowledge at~     present, will not be benefited from the audit. The following described study project~     (prospective clinical trial, uncontrolled, open-label) will be conducted within the~     framework of the statutory tasks of the Department of Pulmonology and Allergology of~     Children Medical University of Warsaw and is a non-commercial project.~   "
22420|NCT02763709|"~     Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders~     characterized by generalized weakness developing after the onset of critical illness.~     Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case~     series of no more than five children. Critical illness polyneuropathy is characterized by~     reduction in compound motor action potential or sensory nerve action potential or both with~     preserved conduction velocity on electrophysiological studies. These findings can occur very~     early prior to the onset of clinical features. Given the dearth of data in children on the~     subject, this study has been planned to evaluate the incidence of critical illness~     associated polyneuropathy /myopathy in severely sick children admitted.~   "
22430|NCT02763579|"~     This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is~     designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death ligand 1~     [anti-PD-L1]) in combination with carboplatin plus (+) etoposide compared with treatment~     with placebo + carboplatin + etoposide in treatment-naive participants with extensive-stage~     small cell lung cancer (ES-SCLC). Participants will be randomized in a 1:1 ratio to receive~     either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21~     day-cycles for 4 cycles in the induction phase followed by maintenance with atezolizumab or~     placebo until disease progression (PD) as assessed by the investigator using Response~     Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Treatment can be continued~     until persistent radiographic PD or symptomatic deterioration.~   "
22431|NCT02763566|"~     The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in~     postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor~     receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.~   "
22432|NCT02763553|"~     The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic~     state in critically ill patients on intensive care.~   "
22421|NCT02763696|"~     The vaginal microbiota is an important biological barrier for host against pathogens or~     opportunistic pathogens. Undermining the balance of the vagina is closely related to~     infectious diseases and tumors.~      The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species,~     including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus~     gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella~     vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .~      Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based~     on microscopy and conventional culture method to obtain vaginal microflora information have~     a variety of deviation. For this reason, The in-depth study of complex vaginal flora and the~     correct understanding of disease faces a serious obstacle. With the development of~     High-throughput sequencing technology， metagenomics can get all the composition and~     distribution of microorganisms from the sample which traditional knowledge may not be with~     microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic~     criteria for clinical diagnosis of the disease is necessary.~      In this study, the investigators use high-throughput sequencing technology to detect women~     of childbearing age vaginal microflora of metagenomic distribution. Including bacteria,~     fungi, viruses, protozoa, and other microorganisms. Based on the study results of~     metagenomic, the investigators want to re-cognition thenormal floraof women of~     childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of~     the reference standard.~   "
22422|NCT02763683|"~     The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB)~     Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to~     determine dementia subtypes in patients with Parkinson's disease. The ultimate goal of this~     project is to be able to identify individuals with PD who are at risk of developing~     dementia, and to distinguish the underlying cause of dementia.~   "
22423|NCT02763670|"~     The heart failure is a chronic pathology with prevalence from 2 to 3% of general population,~     a death rate of 50% at 6 months for patients with stage IV, and a probability of death or~     hospitalization or emergency consultation of 40% at 3 years. The care of patients is~     heterogeneous, especially in light of the organization of therapeutic education offered to~     patients and patient monitoring modalities.~      The aim of this study is to investigate the management strategies for patients with chronic~     heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with~     previous hospitalization for heart failure.~      This is a longitudinal observational multicenter study comparing a management strategy~     including patient education and monitoring as part of a hospital dedicated organization and~     an organization of care as usually done in France.~      The primary endpoint was a composite endpoint of morbidity and mortality involving deaths,~     unplanned readmissions and emergency visits for heart failure.~      The expected number of patients is 720 patients (360 per strategy). The follow-up duration~     of 24 months.~   "
22424|NCT02763657|"~     Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than~     Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships~     is critical for the acquisition of deductive reasoning, that is, the ability to reach~     logically valid conclusions from given premises. Behavioral and neuroimaging studies in~     adults suggest processing differences between these relations: While arguments that involve~     linear-orders may be preferentially associated with spatial processing, arguments that~     involve set-inclusions may be preferentially associated with verbal processing. In this~     study, we use functional magnetic resonance imaging to investigate how and when these~     processing differences appear in children from 8 to 14.~   "
22425|NCT02763644|"~     This is a randomized, SoC-controlled, open-label, multi-center study in patients with TAM~     after hematopoietic precursor cell transplantation (HPCT) .~      Study will consist of up to 28 days of screening period, 16 weeks treatment period that can~     be extended to 45 weeks.Approximately 40 patients will be randomized to receive SoC or~     LFG316 plus SoC. Patients will be included in the study if they have diagnosis of TAM and~     poor prognostic markers.~   "
22426|NCT02763631|"~     The aim of this study is to assess the benefit of a portable ventilator generating positive~     end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway~     collapse (EDAC) and tracheobronchomalacia (TBM).~   "
22427|NCT02763618|"~     This study will investigate the effects of an EEG theta/beta ratio Neurofeedback training~     using a case series multiple baseline design. Twelve participants will be assigned to one of~     three different groups that have a different time of intervention onset, or include placebo~     sessions only. The investigators will examine whether the theta/beta ratio Neurofeedback~     training will reduce resting state theta/beta ratio. As a pilot-exploration for future~     studies, also performance on a cognitive interference task will be monitored to see if any~     improvement after NFT on cognitive performance might be a viable subject for future studies.~     All participants (healthy, but selected for above-median theta/beta ratio in previous~     studies in this lab) will start with three resting state EEG baseline sessions, the first~     participant group then continues with 14 theta/beta ratio Neurofeedback sessions, the second~     group continues with six extra baseline EEG measurements, followed by eight Neurofeedback~     training sessions while the third group will continue with 14 placebo training sessions~     only. EEG resting state theta/beta ratio and interference performance will be measured~     during every session.~   "
22428|NCT02763605|"~     Acanthamoebic keratitis is an important corneal disease which may cause severe complication.~     The difficulty in diagnosis, the difficulty in treatment, and the long treatment process are~     factors leading to the poor prognosis of these patients. In this retrospective study, the~     investigators try to analyze the tissue proven Acanthamoebic keratitis diagnosed in our~     hospital. The investigators will focus on the in vivo confocal microscopic results, the~     medical history and the medical/surgical treatment outcome. The investigators will collect~     the tissue proven cases according to the data provided by laboratory diagnosis department~     and pathological department. The in vivo confocal microscopic results will be collected and~     analyzed. The investigators will also look through the photography of the external eyes from~     data stored in PAC system. The medical history and treatment outcome will be studied from~     clinical chart review. From this study, the investigators aimed to find out a easy way of~     diagnosing Acanthamoebic keratitis from in vivo confocal microscopy, and find out a better~     way for treatment.~   "
22429|NCT02763592|"~     The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on~     allodynic symptoms of localized neuropathic pain after knee surgery.~   "
22434|NCT02763527|"~     Background: Smokers attended to outpatient clinics present an excellent 'teachable moment'~     for smoking cessation interventions. This protocol paper describes the rationale and methods~     of a large randomized controlled trial which aims to evaluate the effectiveness of~     negotiating self-determination to reduce cigarette consumption among smokers attending~     outpatient clinics~      Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong~     Kong. Subjects in the intervention group will receive a brief intervention on smoking~     reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think~     about a smoking reduction schedule for themselves after the negotiation with the counsellor.~     Subjects in the control group will receive a brief advice on quitting plus a leaflet on~     smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted.~     The primary outcome measure is biochemically validated abstinence at 6 months. Secondary~     outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day~     point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in~     cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12~     months.~   "
22435|NCT02763514|"~     The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3~     polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory,~     attention, working memory, executive function), subjective mood, alertness and mental~     fatigue after 26 weeks daily supplementation.~   "
22436|NCT02763501|"~     Comparison of participants in a randomised controlled trial (RCT) with observational data~     from patients operated in Sweden during the same period of time. The primary objective is to~     compare effects from a complex surgical intervention from RCT and observational data.~   "
22437|NCT02763488|"~     This study will evaluate blood flow restriction training as a rehabilitation modalities~     following total knee arthroplasty in order to determine if patient reported outcomes and~     objective functional outcomes can be improved through post-operative rehabilitation compared~     to standard physical therapy modalities currently in use.~   "
22438|NCT02763475|"~     The main goal of this study is to evaluate the anti-relapse prophylactic activity of~     inoculating Natural Killer (NK) cells as consolidation therapy of acute myeloid leukemia in~     paediatric patients with cytologic remission. The patients included have intermediate risk~     of relapse and no indication for allogeneic hematopoietic stem cell transplantation.~      After the standard induction and consolidation chemotherapy treatment, patients will receive~     five days of fludarabine to try to kill any minimal residual disease and prevent NK cell~     rejection. Two different NK cells infusions will be performed within one week (day 0 and 7).~     Interleukin 2 (IL-2) will be administrated to increase the cytotoxic activity of NK cells.~   "
22439|NCT02763462|"~     This study is an observational cohort study of hospitalized patients with fever. This study~     will collect demographic data, history of illness, signs and symptoms, results of laboratory~     tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND~     hospitals. Potential study patients will be any patients (both children and adults).~   "
22440|NCT02763449|"~     The purpose of this study is to understand what happens when someone either becomes more~     active or more inactive. This study will measure your energy intake, energy expenditure, and~     body composition under normal conditions, when you become active, and when you become~     inactive.~   "
22441|NCT02763436|"~     The first major intervention a newborn infant is facing following birth is clamping of the~     umbilical cord. This means separation of the infant from the placenta, the newborn becomes~     an independent individual, especially from a cardio-circulatory perspective. Recent~     literature focused very much on the appropriate timing of the cord clamping (CC),~     distinguishing immediate cord clamping (ICC) from delayed cord clamping (DCC). Although~     potential benefits for DCC have been documented, especially for preterm infants, ICC still~     is the most widely used procedure. Although the reasons for this are unclear, a lack of~     understanding of the issues associated with umbilical cord clamping is thought to be a major~     underlying factor.~      In animal research with fetal lambs it has been shown, that aeration of the lung played a~     crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new~     concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung~     was established, calling this Physiological-Based Cord Clamping (PBCC). It was shown, that~     PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral~     oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral~     oxygenation was measured using near infrared spectroscopy (NIRS).~      Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to~     investigate whether PBCC is able to improve systemic and cerebral oxygenation in term~     infants delivered vaginally.~   "
22442|NCT02763423|"~     This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within~     the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The~     purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem~     cell transplantation is effective in the treatment of patients with severe type 1 diabetes.~   "
22443|NCT02763410|"~     Safety during transfusions is a major issue in medical economics. Despite drastic quality~     control measures, transfusion is still a source of short, mid and long-term morbi-mortality.~     This can be explained to some extent by changes in the composition of the packed red blood~     cell (PRBC) supernatant during storage essentially with the appearance of immunologically~     active compounds possibly involved in organ dysfunction on the one hand and post-transfusion~     immunomodulation on the other hand. These phenomena impact upon outcomes for cardiac surgery~     patients.~      In terms of organ dysfunction, kidney failure due to acute tubular necrosis and pulmonary~     failure are the 2 main issues. Following cardiac surgery, 11% of patients will present with~     transient renal dysfunction characterised by a 25% increase in serum creatinine levels and~     3.5% require dialysis. The intensity of acute renal failure (ARF) is correlated to~     resuscitation : a 20% increase in serum creatinine levels 2 to 3 days after surgery~     significantly raises morbidity rates and a 50% increase raises the mortality rate to 10%.~      The precise mechanisms governing post-transfusion immunomodulation have not yet to be~     defined. The appearance of soluble type I Human leukocytes Antigen (HLA) molecules (sHLA-I),~     the FAS ligand (FAS-L) or cluster designation 40 (CD40-L) in the supernatant of PRBCs along~     the storage of blood products may be involved in such phenomena. These molecules are capable~     of activating or triggering the death of innate or adaptive immunity cells, especially the~     Natural Killer (NK) cells.~      Consequently the investigators propose to focus specifically on the detailed composition of~     transfused PRBC supernatants in order to identify the candidate molecules responsible for~     organ dysfunction or post-transfusion immunoparalysis. The investigators will combine a~     clinical approach based on the transcriptional analysis of renal tubular cells in transfused~     patients and an ex-vivo approach investigating the effect of the supernatant on immune cells~     and the Natural Killer cells of healthy volunteers~   "
22445|NCT02763384|"~     The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia~     (T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30%~     of the patients responding to first salvage therapy and long-term survival of only 10%.~     Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an~     unmet clinical need.~      Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell~     leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in~     T-ALL cells reduces tumor growth in an animal model. In this study, the investigators~     propose that the addition of BL-8040 to nelarabine as a salvage therapy for patients with~     relapsed/refractory T-ALL/LBL will result in a higher CR rate than nelarabine alone without~     an increase in toxicity and will allow patients to proceed to a potentially curative~     allogeneic hematopoietic cell transplant.~   "
22446|NCT02763371|"~     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study~     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch~     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive~     functions in the afternoon. The The Cognition Intervention Study Dortmund Continued (Coco)~     connected this two previous studies and investigates the effect of having school lunch~     versus skipping it on children's basal and executive cognitive functions later in the~     afternoon. The present study the Cognition Intervention Study Dortmund- Glycemic Index~     (CogniDo GI) examines the influence of the gylcemic index of lunch on cognitive performance~     of school children in the afternoon.~   "
22447|NCT02763358|"~     This study is designed to test the usability of the Bite Counter in an attempt to reduce~     participants' daily bites while also increasing their daily steps.~   "
22448|NCT02763345|"~     Community Case Management (CCM) is a clinical decision aid used by frontline Health~     Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and~     malaria (amongst other conditions). Children identified has having complicated illness are~     urgently referred to larger health facilities better equipped to clinically manage these~     more complex presentations. There is evidence to suggest HSAs are missing opportunities to~     refer seriously ill children, and parents/caregivers are failing to comply with urgent~     referral recommendations when given; reducing the overall effectiveness of the CCM strategy.~     Use of mobile technology for deploying CCM has been demonstrated in prior research as~     feasible to evaluate, acceptable to health workers and parents/caregivers and improving~     health worker fidelity to the guidelines, but it is unknown if this translates into~     increased referral and referral completion rates. This trial seeks to evaluate the added~     value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic~     Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking~     behavior.~   "
22449|NCT02763332|"~     The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear~     the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the~     central and autonomic nervous systems, neurotransmitters, hormones, immune system, external~     stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly~     expressed by the people who suffer from it is pain.~      The main goal of the present study is to analyse the effect of the kinesiotaping on the~     pain, comfort and postural position of the patient with fibromyalgia.~   "
22450|NCT02763319|"~     The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX~     with BEN in adult patients with relapsed of refractory DLBCL.~   "
22451|NCT02763293|"~     Crohn's disease (CD) is an inflammatory bowel disease with a high prevalence. Its etiology~     is unknown and is considered a multifactorial disease. It is known that the existence of a~     genetic factor, industrialization and development of the country and environmental factors~     have great influence on the appearance of intestinal pathology (the Val; Buderus;~     Molodecky). CD is a chronic inflammatory bowel disease localized throughout the course of~     the digestive tract (oral-anal). The aim of this study is to evaluate the effect of a~     treatment program combining technical nonmanipulative appropriate in affected patients (CD)~     to increase the overall quality of life and related EC, lower abdominal pain direct and~     indirect osteopathic soft, observe the sense of change after treatment, and psychological~     aspects.~   "
22452|NCT02763280|"~     Recently, osteoporosis has been recognized as a serious health problem in the elderly, it~     has also increased in young • middle-aged layer. Ginseng is history 2, 000 years Korean~     typical herbal medicine which is used as a medicinal is known the mystery of Elixir from a~     long time ago. A previous study was administered ginseng extract results in animal models~     induced osteoporosis, the bone-related biomarkers, including improved bone density and bone~     mass.~   "
22453|NCT02763267|"~     It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes~     Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or~     whether it is the result of an imbalance of a placental hormones. Undiscovered placental~     factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To~     elucidate the pathophysiology underlying GDM, the investigators will attempt to discover~     these factors and characterize pregnancy-associated changes in insulin secretion and~     sensitivity in women with and without GDM.~   "
22454|NCT02763254|"~     To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the~     treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and~     Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.~   "
22455|NCT02763241|"~     The investigators proposed that the Cleanoze® is superior to the traditional nasal saline~     irrigation in term of the ease of use which will resulting in a better quality of life of~     the participants. This study will compared the efficacy, adverse reactions, complications~     and ease of use of Cleanoze® comparing with normal saline solution~   "
22456|NCT02763228|"~     The purpose of this research study is to determine whether a physical activity (exercise)~     program in the community will improve the functional and overall health status of older~     women with a history of breast cancer. The physical activity or exercise program is designed~     for all older breast cancer survivors, and in particular for African-Americans and women of~     lower socio-economic status, who are the least likely to engage in physical activity.~   "
22478|NCT02762942|"~     Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal~     misoprostol for induction of labour, vaginal delivery is achieved in less time compared with~     vaginal misoprostol alone.~   "
22457|NCT02763215|"~     This is a 24-month study to assess copper (Cu) parameters in subjects with Wilson Disease~     treated with standard of care (SOC) medications. Data will be collected during routinely~     scheduled Wilson Disease clinic visits at approximately 6-month intervals.~      After providing informed consent, subjects meeting all inclusion and no exclusion criteria~     will be enrolled into the study as outpatients. Subject's routine Wilson Disease clinic~     visits will be scheduled according to the standard clinical practice at the study center and~     at the discretion of the treating physician at approximate 6-month intervals.~      At the time of enrollment, subjects will be receiving SOC therapeutic agents for the~     treatment of Wilson Disease. If treatment is interrupted or stopped during the course of the~     study, subjects will continue in the study and biological samples and clinical data will~     continue to be collected for the full 24-month study period. Dosing with SOC agents, which~     can include penicillamine, trientine, zinc, or a combination of a Cu chelator and zinc, will~     be individualized and managed by the treating physician at the study center according to~     standard clinical practice at the site.~   "
22458|NCT02763202|"~     The purpose of this study is to better enhance transitions of care for the highest risk,~     complex patients, Carolinas HealthCare System (CHS) has designed an Integrated Practice~     Unit, called Transition Services (CHS-TS).CHS-TS aims to improve patient outcomes through~     innovative approaches that leverage analytics and technology, while bridging care~     coordination and communication gaps. During their hospitalization, CHS-TS patients enter~     into a transition pathway that includes the following key services: integrated access to~     medical, pharmacist, and specialty providers; access to CHS disease specific management~     programs; dedicated care management services delivered in home and at the clinic; lab and~     infusion services; palliative care consultations when appropriate; and paramedicine for 24~     hour support. AIRTIGHT (Aiming to Improve Readmissions Through InteGrated Hospital~     Transitions) is a pragmatic, randomized quality improvement evaluation, which seeks to~     evaluate the effects of the role-out of CHS-TS services for patients at high risk for a~     30-day readmission. AIRTIGHT will test the hypothesis that patients that receive care~     through CHS-TS will have a lower all cause, 30-day readmission rate than patients that~     receive usual care.~   "
22459|NCT02763189|"~     The purpose of this pilot study is to compare the time it takes to change a breathing tube~     with a new device, performed by two different groups of anesthesiologists; one group will~     study on their own how to change the tube, while the second group will also receive expert~     training, before either group performs the procedure for the very first time. The~     Investigators predict the group who gets expert training will change the tube faster, and~     those investigators also need to learn how much faster, before moving to a larger study.~   "
22460|NCT02763176|"~     This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women~     presenting at prenatal care at the study site who are 70 days gestation or less will be~     offered participation in the study. 75 consenting women will be asked to provide urine for~     an MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77~     days' gestation, and 75 consenting women will be asked to provide urine for an MLPT and to~     have blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.~   "
22461|NCT02763163|"~     These days many studies are conducted testing the symbiosis between the bacteria population~     to the human body's functioning. The research of the connection between the skin condition~     and the bacteria population is in its early stages. There is a characterization of different~     bacteria for different body areas depending on their composition, humidity etc. In addition,~     there are preliminary findings of biological receptors that react to the contact with~     bacteria on the surface of the skin and turn on the immune system, awakening it to cope with~     the new invader. Based on the above information, the investigators hypothesis is that there~     is a connection between the degrees of sun exposure of individuals to the growing of~     beneficial bacteria populations on the surface of the skin. The study will compare between~     the bacteria population on the skin of Israeli subjects, divided to two groups, one with an~     excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards,~     construction, etc.), and the other of the office worker who spend most of the day in a~     closed shaded room.~   "
22462|NCT02763150|"~     The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle~     intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women~     with overweight or obesity.~   "
22463|NCT02763137|"~     This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and~     efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD)~     vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced~     Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to~     assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs.~     intermittent administration of standard oral LD/CD. For purposes of this study continuous~     intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute~     intervals.~      Secondary objectives are to assess the safety and tolerability of continuous intra-oral~     administration of LD/CD and the effect on PD motor function of continuous intra-oral~     administration of LD/CD vs. intermittent administration of standard oral LD/CD.~   "
22464|NCT02763124|"~     To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce~     astigmatism in a pseudophakic population.~   "
22465|NCT02763111|"~     BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal~     antibody to interleukin 17. During BCD-085-2 trial patients with active ankylosing~     spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6,~     8, 10, 12. Efficacy and safety parameters will be evaluated.~   "
22479|NCT02762929|"~     A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of~     Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy~   "
22561|NCT02761863|"~     This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome~     of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum~     protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before~     starting treatment using IHC and the results will be correlated with the outcome of~     treatment during evaluation.~   "
25187|NCT02727504|"~     Investigators sought to demonstrate that the increase in the stroke volume during a~     dobutamine stress echocardiography might impact the prognosis of a patient addressed for a~     low flow low gradient suspected severe aortic valve stenosis.~   "
22466|NCT02763098|"~     Effects of different doses of remifentanil on hemodynamic response to anesthesia induction~     in elderly patients ABSTRACT OBJECTİVE: The investigators compared the effects of three~     different doses of remifentanil infusion, which have been performed for the induction of~     anesthesia in elder patients, on cardiovascular response.~      PATIENTS AND METHODS: The present study was designed as a randomized, prospective and~     double-blind study. A total of 90 ASA I-II patients over the age of 65 years were enrolled~     and each group consisted of 30 subjects. The patients were randomly (by lot) assigned to~     receive one of the three doses of remifentanil infusion (0.1, 0.2 or 0.3 µg/kg/min) for two~     minutes. Subsequently, 0.5 mg/kg propofol was administered via IV route and, 0.5 mg/kg~     rocuronium was administered via IV route at the time eyelash reflex disappeared. Intubation~     was performed after two minutes. After recording baseline values of heart rate (HR),~     systolic arterial pressure (SBP), diastolic arterial pressure (DBP) and mean arterial~     pressure (MAP), these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of~     induction.~   "
22467|NCT02763085|"~     Evaluation of a new basic filling restorative material.~      In contemporary dentistry, clinicians have essentially three types of material choices for~     direct restorations: amalgam, resin composite, and glass ionomer restoratives.~      Due to the toxicity of mercury and the subsequent environmental problems, the search for~     alternatives continues and search into new composite restorative materials intensifies.~     Recognized disadvantages of tooth colored resin based restorative materials are as~     polymerization shrinkage, postoperative sensitivity and technical procedure complexity.~     Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer~     restoratives.~      Therefore, alternative materials are being developed to compensate the disadvantages of~     current contemporary tooth coloured restorative materials. Nevertheless, the search for~     simplification for restoring missing dental tissues introduced the basic filling concept.~      This project aims to study the clinical performance of this new basic filling restorative~     material for Class I and Class II cavities. 80 patients are recruited to the project which~     is carried out at the School of dentistry, Istanbul Medipol University, Turkey.~   "
22468|NCT02763072|"~     The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of~     two laser systems for improvement of lentigines on the hands.~   "
22469|NCT02763059|"~     Background and aim: Postoperative pain is an adverse effect of oral surgeries and may~     therefore be prevented or minimized. This study compares the efficacy of preemptive~     ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant~     placement.~      Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized~     clinical trial, 117 dental implants were placed. The groups received three different~     protocols 1 hour before surgery:~        1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);~        2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or~        3. placebo.~      Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to~     take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and~     visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate~     scale, hourly for the first 8 hours after surgery and three times a day on the following 3~     days.~   "
22470|NCT02763046|"~     The current study will assess the clinical Assessment of SpondyloArthritis international~     Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant~     nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated~     with Secukinumab or placebo following an initial run-in phase of stable NSAID therapy. In~     case of a positive outcome concerning the NSAID reduction this study could trigger the~     development of a guidance concerning NSAID reduction applicable for all Ankylosing~     Spondylitis (AS) patients starting a biologic treatment.~   "
22471|NCT02763033|"~     Investigators are evaluating the feasibility, safety and early efficacy of administering a~     commercially available dietary supplement containing potato-based resistant starch to~     subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin~     immediately prior to the conditioning phase and continue through day 100. Investigators~     hypothesize that short term administration of a resistant starch is capable of increasing~     levels of butyrate within the intestine that will reduce rates of acute GVHD~     (Graft-Versus-Host Disease).~   "
22472|NCT02763020|"~     Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health~     that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to~     determine whether the fortification of a high sugar food item with a polyphenol-rich~     freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other~     positive physiological changes (e.g., satiety) in a dose-response manner. This study will~     test four different types of snack bar with various polyphenol doses, and compare blood~     response to a snack bar without polyphenols.~   "
22473|NCT02763007|"~     Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open~     label extension trial for 28 weeks followed by 2 year observational study.~   "
22474|NCT02762994|"~     BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal~     antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque~     psoriasis, in whom poor response to previous treatment including UV-therapy and biologic~     drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1,~     2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.~   "
22475|NCT02762981|"~     The purpose of this study is to assess the safety of the combination of CORT125134, a novel~     glucocorticoid receptor (GR) antagonist, and nab-paclitaxel in patients with solid tumors~     and to determine the preliminary efficacy of the combination of CORT125134 and~     nab-paclitaxel in patients with solid tumors. The structure for the study is a single arm,~     non-randomized, open-label, multicenter trial with no control group. The study will be~     conducted at approximately 8 sites with approximately 82 evaluable patients.~   "
22476|NCT02762968|"~     The study will determine whether acute ingestion of a probiotic combined with~     beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers~     during 8-weeks of advanced infantry training.~   "
22477|NCT02762955|"~     CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy,~     safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD,~     Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.~   "
22480|NCT02762916|"~     The current increase in chronic diseases calls for changes to the health system. It is~     necessary to promote expert patient in chronic disease. The expansion of new technologies~     gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The~     characteristics of peripheral arterial disease make possible to promote expert patient and~     the self-management. In order to bring these concepts together the telemedicine program was~     created to promote expert patient for increasing the quality of life and satisfaction of~     patients and improving the efficiency of the health system.~      Methods: Randomized clinical trial on patients with peripheral arterial disease in~     intermittent claudication grade. They were randomized into two groups: intervention arm (IA)~     using CONTECI program for self-managing and control arm (CA), followed as usual vascular~     visits.~   "
22481|NCT02762903|"~     The primary objective of this study is to assess the clinical effectiveness of two different~     techniques used for subscapularis tendon repair during total shoulder replacement. The~     investigators hypothesize that participants who receive a newer repair technique called a~     lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle~     dysfunction and rupture as compared to those who receive the traditional tenotomy repair.~   "
22482|NCT02762890|"~     The purpose of this study is to investigate and compare the postoperative quality of~     recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during~     robotic gastrectomy.~   "
22483|NCT02762877|"~     A study to determine the concordance of key actionable genomic alterations as assessed in~     tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)~   "
22484|NCT02762864|"~     To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change~     in~        1. time of initial leg pain and time of termination of exercise test by pain, evaluated on~          the graded stationary bicycle test,~        2. the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and~          dynamic contrast enhancement sequences and measures the extracellular volume fraction~          (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks~          post-revascularization in patients with peripheral artery disease who have undergone~          endovascular revascularization -/+ bypass surgery for moderate to severe claudication~          or ischemic rest pain.~   "
22485|NCT02762851|"~     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for~     vascular events from the network of INTER- CHF will be randomized to inactivated influenza~     vaccine or placebo and followed prospectively over three influenza seasons. 3,500~     participants will be enrolled prior to influenza season, randomized to either influenza~     vaccine or saline placebo, either of which they will receive annually for three years and~     then followed over each of the influenza seasons.~   "
22486|NCT02762838|"~     BCD-055-3 is international multi-center comparative double-blind randomized clinical trial~     of efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in combination with~     methotrexate in patients with active rheumatoid arthritis.~   "
22487|NCT02762825|"~     Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and~     mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to~     be consistently beneficial in treating these problems. However, increasing evidence suggests~     that exercise training is effective for both partially reversing exercise intolerance and~     improving quality of life in these patients. Most such trials to date have been conducted in~     controlled research setting, versus integrating these patients in to a standard CR program.~     Also, since functional capacity is related to outcomes in these patients, exercise~     strategies aimed at further improving fitness are warranted. One such strategy is using~     higher intensity interval training (HIIT) in the CR setting, a strategy shown to be~     effective in patients with other types of CVD. This project is designed to test the~     feasibility of incorporating these patients into the CR setting, and training them using a~     methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains~     in fitness when compared to what was achieved using standard MCT alone.~   "
22488|NCT02762812|"~     BCD-055-2 is international multi-center comparative double-blind randomized clinical trial~     to evaluate efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in patients~     with ankylosing spondylitis.~      BCD-055 is biosimilar of infliximab (JSC BIOCAD, Russia)~   "
22489|NCT02762799|"~     BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and~     safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®~   "
22490|NCT02762786|"~     This study aims to examine the effectiveness of musical training in in improving the~     psychological well-being, in particular their self-esteem, depression, happiness and quality~     of life of children from low income families.Half of the participants will receive weekly~     one-hour lessons on musical training for 12 weeks, while the other half are the placebo~     controls.~   "
22491|NCT02762773|"~     The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus~     sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain~     control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.~   "
22492|NCT02762760|"~     This study will evaluate the safety of an intra-articular injection of AMPION™ in adults~     with pain due to osteoarthritis of the basal thumb joint.~   "
22493|NCT02762747|"~     This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal~     hernioplasty. We will assess the difference in seroma formation after surgery in 2 two~     groups by an independent assessor clinically and radiologist to document the size of seroma~     after surgery. Other secondary outcomes will be measured including post-operative pain,~     discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection,~     etc.~   "
22523|NCT02762357|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with other suture material used for episiotomy. In order to show that, various~     safety and efficacy parameters have been selected. The outcome regarding these parameters~     will be evaluated by a quantitative summary of the available clinical data from the~     literature. Study population consists of women with a spontaneous vaginal delivery who~     required perineal repair due to an episiotomy.~   "
22605|NCT02761421|"~     To investigate the motor development, motor function and electrodiagnostics presentation in~     IOPD under ERT.~   "
22494|NCT02762734|"~     MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide~     attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6~     months after their suicide attempt (SA), in order to allow them to recourse to the care more~     easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a~     multicenter controlled randomized trial (East of France) and there is a funding from the~     Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who~     are receiving SMS (or mail or other new media) from the unit of care in addition to the~     usual care will do less SA recurrence, than those who are receiving the usual care.~      The primary objective is to determine whether the use of SMS (or mail or other new media) to~     keep in touch with adolescent suicide attempters in addition to the usual care, compare to~     usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the~     SA.~   "
22495|NCT02762721|"~     The primary objective of this study is to estimate the frequency of FGFR2 fusions in~     archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma~     (HCC-CCA) tumor samples~   "
22496|NCT02762708|"~     What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2~     diabetes outside of weight loss alone?~   "
22497|NCT02762695|"~     The purpose of this study is to evaluate whether a new model of health care for chronic~     patients, based on Case Management and guided by a nurse which targets the patient´s risk,~     is more effective than usual care at Primary Health care in Chile. Additionally, this~     intervention would provide a better quality of care and a more efficient health provision.~   "
22498|NCT02762682|"~     PRIMARY OBJECTIVES~      • To describe the vitamin B12 status in children with infantile tremor syndrome(ITS) and Pre~     ITS~      SECONDARY OBJECTIVES~        -  To study the vitamin B12 status in mothers of children with infantile tremor syndrome~          (ITS) and Pre ITS~        -  To study the blood levels of folate in children with infantile tremor syndrome~          (includes Pre ITS) and their mothers.~   "
22499|NCT02762669|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity~     worldwide, and is caused most commonly by poor uterine muscle contraction after delivery of~     the baby and placenta. The first line agent used in the prevention and treatment of PPH is~     oxytocin, which acts by binding with the oxytocin receptor (OTR) found on myometrial cells~     to cause uterine contraction.~      Oxytocin is also used for the augmentation of labor when spontaneous labor has been deemed~     ineffective. It is administered intravenously at progressively higher doses, until effective~     contractions are achieved and vaginal delivery results. However, if augmentation is~     determined to have failed, a Cesarean delivery (CD) is performed.~      One of the potential problems with oxytocin use during delivery is that it loses its~     effectiveness if the uterus has previously been pre-exposed to its high doses and/or for a~     prolonged duration during labor. This phenomenon is termed OTR desensitization, and can~     result in the attenuation of myometrial contractility induced by subsequent oxytocin~     administration, as well as PPH due to poor uterine tone. Furthermore, oxytocin can produce~     potentially fatal maternal hemodynamic adverse effects when administered at high doses, so~     it is advantageous to be able to use as low a dose as possible to obtain good uterine muscle~     tone.~      The objective of this study is to get a better understanding of the signaling pathways~     governing desensitization, resensitization and contractility in pregnant human myometrium.~     The investigators wish to investigate the effects of increasing recovery period on the~     expression patterns of the OTR and its signaling pathways in desensitized pregnant human~     myometrium.~      This study will help shed light on the molecular mechanisms responsible for desensitization~     and oxytocin-induced myometrial contractility, and will provide some insight into potential~     therapeutic targets to reduce the incidence of PPH and complications associated with using~     increasing concentrations of oxytocin.~      The hypothesis is that the expression and phosphorylation patterns of the OTR and downstream~     proteins will be altered in desensitized myometrium, and that these patterns will change~     with increasing rest periods and re-exposure to oxytocin.~   "
22500|NCT02762656|"~     The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine~     intravenous infusion in reducing postoperative pain for spine surgery patients.~   "
22501|NCT02762643|"~     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics~     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each~     component administered alone in healthy male volunteers.~   "
22502|NCT02762630|"~     Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess~     normal alignment of the knee joint~   "
22503|NCT02762617|"~     This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will~     examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate~     (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.~      The primary objective is to assess the safety of TDF vaginal rings when used continuously~     for 84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo~     vaginal ring.~   "
22504|NCT02762604|"~     The investigators propose a single-blind randomized clinical trial to determine if seniors~     show improved mobility (walking speed) and cognition following motor imagery (imagined~     walking) training. They hypothesize that imagined walking can be used as a rehabilitative~     tool for improving walking speed and cognition in the elderly, because it engages and~     strengthens similar neural systems as actual walking and cognition.~   "
22505|NCT02762591|"~     The purpose of this program is to provide patients with PDP access to pimavanserin until the~     product receives marketing approval from the FDA and is commercially available.~   "
22506|NCT02762578|"~     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of~     insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.~   "
22507|NCT02762565|"~     Early detection of breast cancer improves the survival rate and makes treatment less costly.~     This study would measure the accuracy a low-cost hand-held commercially viable device, iBE,~     for the detection of clinically relevant findings in the breast using the results of current~     mammography as a comparison. This research will have no impact on clinical decision making.~   "
22508|NCT02762552|"~     In acute ischemic stroke, the identification of an etiology is of major importance to~     prevent recurrence by providing the best treatment. Because of numerous possible underlying~     etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic~     tests, which can be invasive, long and expensive. Moreover, many patients receive a~     diagnosis of undetermined stroke even after all available diagnosis tests are done,~     precluding optimal treatment.~   "
22524|NCT02762344|"~     Observational cohort registry: prospective, multicenter independent evaluation of patients~     who undergo coronary angiography and/or PCI via radial artery. The purpose of this registry~     is to set the incidence of RAO according to ACT values, considered both as continuous and~     ordinal variable and its determinants. Coronary angiography and PCI will be performed~     according to usual practice.~   "
22606|NCT02761408|"~     The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation~     associating dermatitis or mucositis in head and neck cancer patients who accept~     chemoradiation therapy~   "
22509|NCT02762539|"~     Traumatic brain injury (TBI) is major health problem that stands as a significant cause of~     death and permanent disability. TBI is considered as global public health epidemic. On~     pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary.~     Once a primary insult occurs like trauma or ischemia, the secondary injury begins though~     main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3~     PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with~     the ability to impact all four main mechanisms of the secondary injury Patients will be~     allocated into one of two groups through a random table generation; Control group in which~     patients will follow our local protocol for TBI management without SMOF-lipid infusion.~     SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid~     emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain~     triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU~     for 7 days~   "
22510|NCT02762526|"~     Background: The lipoabdominoplasty can lead to respiratory complications in the~     postoperative period becoming critical early clinical and functional evaluation of~     respiratory muscles, seeking to direct a more effective treatment, which can result in~     shorter hospital stays and lower spending on health in patients undergoing such procedures.~     Objective: To evaluate the correlation of regional distribution of ventilation system with~     thoracoabdominal diaphragmatic mobility in women undergoing surgery lipoabdominoplasty~     comparing preoperative, 10 ° and 30 ° DPO DPO. Methods: This is a prospective cohort study,~     which will be evaluated 30 women aged 25 to 55 years undergoing lipoabdominoplasty surgery~     without respiratory or prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2.~     women smokers are deleted and / or a history of smoking more than 10 years and unable to~     understand the commands to perform the proposed methods. For evaluation of diaphragmatic~     mobility will be used high-resolution ultrasound with convex 3.5 MHz transducer. The~     evaluation of the regional distribution of ventilation thoracoabdominal system will be made~     using the optoelectronic plethysmograph (POE). The strength of the inspiratory and~     expiratory muscles is measured through a digital manometer connected to a nozzle with an~     orifice of 2 mm to reduce the closing pressure of the glottis. A portable spirometer is used~     for assessment of pulmonary function and evaluation of dyspnea will be used modified Borg~     scale. The data will be evaluated in the preoperative period, 10 days and 30 days~     postoperatively. Hypotheses: Patients undergoing surgery lipoabdominoplasty have decreased~     diaphragmatic mobility, strength and respiratory function, in addition to presenting changes~     in the pattern of regional ventilation distribution in torocoabdominal system in the~     postoperative period when compared to the preconditions surgery.~   "
22511|NCT02762513|"~     This study will be a prospective, single-institution, single-arm phase II study of Axitinib~     in patients with unresectable recurrent and metastatic head and neck squamous cell~     carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day~     continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the~     absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic~     response assessment after 8 weeks and subsequently every 2 months until disease progression~     or intolerable toxicity.~   "
22512|NCT02762500|"~     The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally~     once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score~     (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1~     at screening.~   "
22513|NCT02762487|"~     The purpose of this study is to evaluate the LINX device in patients who have previously~     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic~     gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux~     symptoms.~   "
22514|NCT02762474|"~     This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for~     unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy~     regimen for local advanced and unresectable esophageal cancer patients.~   "
22515|NCT02762461|"~     This project will investigate worsening of symptoms in endometriosis patients undergoing~     artificial reproductive techniques (ART). The study compares patients with~     peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups.~     Symptoms are monitored with a questionnaire with the categories quality of life, pain and~     bowel habits. The EHP-30® questionnaire is included in the questionnaire.~   "
22516|NCT02762448|"~     Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin~     Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study~   "
22517|NCT02762435|"~     After written informed consent eligible hospitalized patients will be randomized to one of 3~     arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per~     day). Quality of recovery and other measures of patient satisfaction will be recorded.~   "
22518|NCT02762422|"~     Blood donation has been proposed to be associated with reduced risk of cardiovascular~     disease, but the effects of phlebotomy on vascular function in human subjects have not been~     well characterized. A prospective randomized double-blind study was undertaken to determine~     the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular~     endothelial function in the brachial artery.~   "
22519|NCT02762409|"~     Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce~     Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by~     the patients of intensive care, implemented at the level of the whole intensive care unit,~     reduce the incidence of the depressive symptoms one year after intensive care exit.~   "
22520|NCT02762396|"~     NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young~     adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness~     and plaques and consequences of stroke are examined by standardized diagnostics.~   "
22521|NCT02762383|"~     This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in~     participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).~     Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA)~     after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive~     a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate~     safety and tolerability. Secondary objectives are to evaluate histological, virological, and~     biochemical effects.~   "
22522|NCT02762370|"~     This study is a double-blind, randomized, parallel group comparison of the effects of FX006~     and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the~     protocol) on blood glucose in patients with osteoarthritis of the knee and Type 2 diabetes~     mellitus.~   "
22547|NCT02762045|"~     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to~     evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects~     receiving stable highly active antiretroviral therapy(HAART) .~   "
22525|NCT02762331|"~     Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac~     surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following~     CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third~     post-operative day. Reduction of AF by various drugs is moderately effective, but involves~     either rate control with beta blockers or rate conversion with amiodarone after the~     myocardial damage processes initiating AF have already occurred. Decreasing the incidence of~     post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could~     be more fruitfully approached by targeting the upstream combined processes of inflammation~     and coagulation activation induced by the surgical insult and associated~     ischemia-reperfusion (I/R). We propose that cell damage induced by oxidative stress and I/R~     injury could be prevented and/or inhibited by antioxidant supplementation. Specifically the~     investigators hypothesize that high-dose intravenous (IV) vitamin C supplementation will~     ameliorate ROS and therefore damp down upstream inflammatory processes, leading to a~     reduction of downstream adverse events with demonstrable links to inflammation processes,~     such as AF.~   "
22526|NCT02762318|"~     Identify novel genetic variants causing skeletal dysplasia in Qatari populations and to~     additionally develop an understanding of how those variants influence skeletal biology at a~     molecular and cellular level.~   "
22527|NCT02762305|"~     The hypothesis of this study is that participation in the Retired and Senior Volunteer~     Program (RSVP) Bone Builders program 1 hour, twice per week, for a minimum of 12 weeks will~     result in significant positive changes to the health status of older adult participants~     compared to controls including increased leg strength, improved balance, improved balance~     confidence, increased walking speed, decreased fall risk, and increased life satisfaction.~   "
22528|NCT02762292|"~     Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is~     shared between the patient and the ventilator. During weaning from mechanical ventilation,~     the WOB performed by the patient must be adequate and efficient to sustain spontaneous~     ventilation after extubation. The monitoring of WOB during weaning might allow a better~     management of the weaning process. Esophageal pressure (PES) is the reference technique to~     measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect~     Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in~     WOB in mechanically ventilated children during weaning from mechanical ventilation. The~     primary objective of this study is to assess the validity of IC method for the WOB~     assessment when compared to PES measurement and Electrical Activity of the diaphragm (EAdi)~     during a spontaneous breathing trial (SBT) in continuous positive airway pressure, which is~     a routine extubation readiness test which generally induces an increase in WOB.~      Methods This is a prospective single center study. All intubated and mechanically ventilated~     children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will~     be eligible.~      Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3~     steps: before, during and after the SBT. Then outcome of patients will be collected.~      The investigators plan to study a sample of 15 patients to be representative.~      Relevance to the importance of child health in Canada The investigators expect that the~     IC-based less invasive method will provide an accurate estimation of WOB assessment. Once~     this tool is validated, the interest of IC to (i) early detect an increase in WOB during~     mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to~     optimize nutritional support will be assessed in future studies.~   "
22529|NCT02762279|"~     Background During ventilatory assistance, optimization of settings is critical to allow a~     personalized support and avoid over- or under-assistance. But little data are available in~     clinical practice to guide the adjustment of the support. In adults, esophageal pressure~     (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical~     studies suggest that PES may be useful to guide the management of mechanical ventilation. In~     children, the PES measurement could have similar potential benefits, but beforehand the~     reliability of PES to estimate PPL needs to be assessed.~      Objective The primary objective of this study is to validate the reliability of PES directly~     monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate~     PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.~      Method This is a prospective single center study. Children <18 years old, hospitalized in~     the pediatric intensive care unit, requiring invasive ventilation and with at least one~     chest tube will be included.~      Protocol A pressure transducer will be connected to the existing chest-tube and PES~     (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be~     simultaneously recorded.~      Expected results We expect that the PES-based methods will provide an accurate estimation of~     PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in~     children, and further interventional trials would be warranted to evaluate if its use could~     allow a reduction of the ventilation support duration.~   "
22530|NCT02762266|"~     This randomized phase III trial studies how well transarterial chemoembolization (TACE)~     works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative~     radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove~     the cancer have been made (residual) or has come back (recurrent). TACE is a minimally~     invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy~     medication and embolization materials into the blood vessels that lead to the tumors. SBRT~     or SABR may be able to send radiation directly to the tumor and cause less damage to normal~     liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in~     treating patients with persistent or recurrent liver cancer who have undergone initial TACE.~   "
22531|NCT02762253|"~     This study is being conducted to assess the safety and effectiveness of photochemically~     induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and~     Ecstasia.~   "
22532|NCT02762240|"~     Accreditation is used increasingly in health systems worldwide. However, there is a lack of~     evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate~     the effectiveness of a mandatory accreditation in general practice.~   "
22533|NCT02762227|"~     This prospective cohort study is designed to investigate and to compare the diagnostic~     performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed~     tomography (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.~   "
22534|NCT02762214|"~     Prospective multicentric randomized trial to evaluate the role of uterine manipulator on~     laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial~     cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).~   "
22535|NCT02762201|"~     This study aims to compare the therapeutic efficiency of implant-secured removable partial~     denture (PASI) with the therapeutic efficiency of the metalic standard removable partial~     denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The~     therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.~   "
22536|NCT02762188|"~     Age-Related Macular Degeneration (ARMD) is the most common cause of blindness in the adult~     population of the Western World. It affects the macula - the region of the retina most rich~     in photoreceptors and responsible for central vision. The ethiology of ARMD remains poorly~     understood. Population-based studies have demonstrated a complex ethiology, with~     contributions from a combination of genetic and environmental factors.~      Two major forms of ARMD are clinically distinguishable: the dry and wet form. The latter~     represents the more aggressive clinical subgroup, and is characterized by the abnormal~     growth of new blood vessels (neovascularization) under the macula, thus leading to the~     accumulation of fluid under the retina, bleeding, progression to fibrosis, and finally loss~     of central vision.~      The pathogenesis of this neovascularization is not fully understood, although the VEGF~     pathway is well known to be involved in angiogenesis and was implicated in the development~     of the new vessels under the macula. The VEGFs are the most specific and potent stimulators~     of the angiogenesis.~      Molecules that bind and inactivate the VEGF have been developed for the treatment of ARMD~     and they are applied in ARMD clinic through intra vitreal injections.The difference seen in~     response to anti VEGF treatment for ARMD between the patients is suggestive for the presence~     of factors influencing the effect of the drug. Some of these could be genetic variants~     within genes involved in ARMD pathogenesis or VEGF pathway. Few associations with markers~     within genes previously found to be related with the pathogenesis of ARMD have been found.~     It remains unknown whether variants involved in the anti VEGF treatment response could~     influence the therapeutic outcome.~      The purpose of this trial is to evaluate the association between a panel of selected~     polymorphic markers in the VEGF pathway and the response to therapy with anti VEGF antibody~     for ARMD. The hypothesis is that the individual genotype influences the response to the anti~     VEGF. This can lead to identification of genetic biomarkers allowing treatment~     individualization and optimization of the visual outcomes.~   "
22537|NCT02762175|"~     Background~      Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized~     by intense snoring and repetitive complete or partial obstructions of the upper airway~     during sleep together with daytime sleepiness. Several non-invasive therapeutical options~     exist, however, they do not offer a permanent improvement. Maxillomandibular advancement~     (MMA) surgery is a procedure which changes the upper airway in a permanent way.~      Objectives~      The investigators aim to develop a prospective database registering 3D volumetric changes of~     the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of~     life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient~     demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters,~     orthognathic surgery, polysomnographic and QOL data are being collected during consecutive~     visits within the framework of routine practice.~      Design~      A prospective, observational cohort study~      Study center~      General Hospital (AZ) Sint-Jan Brugge-Oostende~      Population~      The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr.~     Neyt starting from January 2015.~      Endpoints~      The investigators aim to collect data that could provide information about the advantages~     and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for~     OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic~     subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness~     Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the~     apnea-hypopnea index (AHI).~      Duration~      In light of the continuous improvement of patient care, a database will be maintained from~     January 2015 onwards to enable registration of large-scale OSAS patient data.~      Conclusions~      Development of a database registering 3D CBCT planning, polysomnographic data and quality of~     life (QOL) of all consecutive patients eligible for MMA, will provide more information about~     potential patient, virtual planning and surgical factors influencing accuracy of MMA, and~     the associated biological benefits of this procedure on the upper airway volume, the AHI and~     general QOL. Moreover, registration of those results could function as a measurement of~     quality of care, or could be used for sample size calculation for future large multicenter~     prospective trials.~   "
22538|NCT02762162|"~     ONASSIST is a registry of coronary ill patients who have had a functional test measuring~     anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.~   "
22539|NCT02762149|"~     Epidural analgesia is commonly used for labor pain relief due to its safety and~     effectiveness. Despite a very high success rate, the epidural technique remains a somewhat~     blind technique and failures continue to occur. Unfortunately, there are no imaging~     techniques that can be used at the bedside to determine the proper positioning of the~     epidural catheter. The trans-catheter electric stimulation test (TCEST) has been~     successfully used for this purpose. This test is occasionally performed in situations where~     the immediate confirmation of the proper epidural catheter location is deemed necessary. The~     test helps to predict which epidurals might fail so that appropriate measures could be~     immediately implemented.~      There has been one duration of electrical stimulus (0.2 milliseconds) that has been used in~     the majority of studies and in clinical practice. With this duration of stimulation, the~     vast majority of cases show a unilateral motor response of the lower limbs during the TCEST.~     Studies on the stimulation of peripheral nerves (nerves in the arms and legs) have shown~     that an electrical stimulus with a longer duration is able to stimulate nerves which are~     farther away. Since nerves in the epidural space are similar in composition to peripheral~     nerves, the investigators expect to see a higher rate of bilateral response with the longer~     duration of stimulus. The investigators also hope to show that this bilateral response is~     predictive of a better functioning epidural.~      The investigators hypothesize that the incidence of a bilateral response to the TCEST will~     be higher with the 1.0 ms pulse width compared to 0.1 ms pulse width. Furthermore, the~     investigators hypothesize that a bilateral motor response associated with the 1.0 ms pulse~     width will be predictive of symmetry of sensory and motor block and of lower consumption of~     local anesthetic.~   "
22540|NCT02762136|"~     Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with~     high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD.~     Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG)~     for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence~     of randomized placebo-controlled study is needed.~   "
22541|NCT02762123|"~     The study is being conducted to assess the effect of BMS-986142 on the single-dose PK~     parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for~     (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.~   "
22542|NCT02762110|"~     Evaluate the feasibility of using a novel imaging test, [18F]ISO-1 PET/CT to image sigma-2~     receptor binding in cancer. Correlate uptake with standard and experimental pathology assays~     of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18~     years, with a known or suspected breast cancer and at least one lesion 1.0 cm in size by at~     least one type of standard imaging.~   "
22543|NCT02762097|"~     Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation~     of embryo and lead to subfertility.This study evaluates whether removal of endometrial~     polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility~     can be found. Half of the women would have these polyps removed after their consent and the~     other half who would not consent would not undergo any such intervention~   "
22544|NCT02762084|"~     Multicenter, double-blind, randomized, vehicle-controlled evaluates the efficacy and safety~     of patidegib gel, 2% and 4% in comparison with vehicle in subjects at least 18 years of age~     that meet the diagnostic criteria for basal cell nevus syndrome (BCNS). Subjects will be~     randomized to receive patidegib gel 4%, patidegib gel 2%, or the vehicle gel for a 26 week~     treatment period.~   "
22545|NCT02762071|"~     This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for~     pain control after total shoulder replacements. Each method will be assessed in terms of~     post operative pain scores, pain medication consumption, length of stay, complications~     (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain.~     The aims of this study will be achieved through a randomized controlled trial and~     cost-effectiveness analysis.~   "
22546|NCT02762058|"~     The goal of this study is to investigate the effects of virtual reality based mirror therapy~     (VMT) on individuals with acquired brain injury when compared to a control group receiving~     traditional mirror therapy (TMT). This is a randomized controlled pilot study in which~     patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity~     function will be observed.~   "
22549|NCT02762019|"~     Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side~     effects among which oral mucositis (OM) is one of the most debilitating. Modifications of~     CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor~     general conditions and debilitation. Moreover, the use of narcotic analgesics and total~     parenteral nutrition may be required, triggering not only a physical deficit but also an~     economic burden. Despite the frequency and impact of OM among children with cancer, there is~     no consensus on standard therapy for this condition. Previous studies demonstrated that high~     power laser therapy can help the maintenance of nutritional status in patients with OM and~     can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in~     reducing symptoms and in preventing the onset of OM in adult cancer patients but only one~     randomized controlled trial, with a limited number of children enrolled, supports its use in~     children for treatment of OM induced by chemotherapy.~      This multicenter double-blind randomized controlled trial evaluates the efficacy of laser~     for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.~      The study involves 8 italian hospitals.~   "
22550|NCT02762006|"~     The purpose of this study is to investigate the safety and feasibility of administering~     investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney~     cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736,~     and the second drug is called tremelimumab. Both of these drugs work by attaching to certain~     proteins on immune cells with the goal of stimulating an immune response against cancer~     cells. This is a phase 1 trial, with the primary goal of identifying if this treatment is~     safe and possible side effects when given prior to surgery for kidney cancer.~   "
22551|NCT02761993|"~     The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an~     adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal~     disease.~   "
22552|NCT02761980|"~     This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose~     Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with~     fever. Results for the Fixed Dose Combination product will be compared to the individual~     components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.~   "
22553|NCT02761967|"~     This study evaluates whether the use of moderate physical exercise character in water is~     beneficial for pregnant women. Half of the participants will carry out moderate physical~     exercise character in water, following the protocol developed specifically for this purpose~     and called SWEP method, while the other group will not perform physical exercise during~     pregnancy.~      Concluded the postpartum period, women perform exercises aimed postpartum recovery. The~     women's group has conducted exercises during pregnancy postpartum recovery made under the~     guidance of LPF method.~   "
22554|NCT02761954|"~     With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and~     the basilar artery (BA) after the caudal block changes.~   "
22555|NCT02761941|"~     The aim of this study is to investigate the clinical significance of high INR (International~     Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial~     fibrillation. The clinical characteristics of these patients will be studied as well as the~     clinical presentation. Factors influencing on high INR values will be recorded and the aim~     is to seek out patients who have elevated risk of bleeding complications.~   "
22556|NCT02761928|"~     Observational study of axial spine pain and hyperflexibility. Patients will receive physical~     exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's~     hypermobility score) and blood / urine / saliva collection. They will also be separated into~     pain groups based on their response to injections. A correlation between exam findings and~     procedure group will be measured.~   "
22557|NCT02761915|"~     The purpose of this first in human study is to determine the safety and feasibility of~     1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is~     a novel immunotherapy under investigation in which patients have their T-cells (a type of~     white blood cell) collected and modified in the laboratory, before they are given back to~     the patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which~     targets disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.~   "
22558|NCT02761902|"~     The study is designed to investigate normal polysomnographic respiratory values of Chinese~     healthy children and adolescents. By collecting the polysomnography (PSG) data and~     parameters of respiratory and sleep architecture，we hope to characterize normal~     polysomnography values in Chinese children and adolescents and to establish respiratory~     reference values for pediatric polysomnography which based on Chinese children's data.~   "
22559|NCT02761889|"~     The present study evaluates the clinical outcomes following definitive ultra-high dose per~     fraction external beam radiation therapy delivered in patients with organ-confined~     adenocarcinoma of the prostate.~      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc~     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance~     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of~     devices that ensure stability and beam location reproducibility. A rectal balloon with air~     filling will be used for prostate target immobilization and anatomical reproducibility,~     while a urethral catheter loaded with beacon transponders will be used to ensure set-up~     reproducibility and online target tracking. Previously untreated patients with prostate~     cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.~      Patients will be followed at one month post-treatment and every 3 months for up to 12 months~     (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity~     evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and~     will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC),~     International prostate symptom score (IPSS) and International index of erectile function~     (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the~     same schedule as clinical follow-up. Patients will be continuously monitored for a minimum~     of 5 years.~   "
22560|NCT02761876|"~     The purpose of this study is to test if a participatory, agroecological peer farmer-led~     education intervention can be effective at improving legume production, food security, and~     infant and young child feeding practices in Singida District, Tanzania.~   "
22562|NCT02761850|"~     The purpose of prospective cohort study is to describe the developmental profile of~     refraction change in a large cohort of Chinese CC patients. The decisive factors to the~     range of myopic shift in unilateral CC appeared to be different from that in bilateral CC,~     indicating dramatic differences in the etiopathogenesis and refractive prognosis between~     bilateral and unilateral CC.~   "
22563|NCT02761837|"~     The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness,~     cost-effectiveness, and implementation of the Breathe Well intervention, which combines~     evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care~     to improve asthma outcomes.~   "
22564|NCT02761824|"~     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life~     Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction (with~     evidenced gathered at three consecutive periods and geographical locations through Quality~     of Life surveys).~   "
22565|NCT02761811|"~     To evaluate the safety and efficacy of targeted renal sympathetic denervation using~     SyMapCath I™ in patients with pharmacotherapy and uncontrolled hypertension for at least 6~     months, then after standardized antihypertensive drug therapy (at least two drugs) for at~     least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.~   "
22566|NCT02761798|"~     This observational study aims to validate the use of a tablet based audiometer to provide an~     accurate, efficient, and cost-effective means for diagnosis of hearing conditions in~     controlled and uncontrolled environments in adult and elderly populations.~   "
22567|NCT02761785|"~     The research aims to investigate how gluten-free oats affect the gastrointestinal health in~     celiac disease by analyzing the effects of gluten-free oats on the intestinal parameters and~     on the composition of the gut microbiota and the metabolic profile of celiac patients. The~     study is divided into two parts.~      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over~     study. Celiacs who avoid oats because of gastrointestinal symptoms will be recruited as~     subjects. The aim is to recruit 15 participants for the part 1. The study will be conducted~     with a cross-over setting, where the subjects will go through the exposure meal and~     SmartPill ingestion two times (oat and placebo) in randomized order. The study meals are~     identical in appearance and fiber content. After consuming the meal subjects will ingest the~     SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the~     external portable device. Before and during the passage of capsule the subjects will fill a~     symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected~     by the external device will be collected and analyzed. Before the oat/placebo exposure the~     subjects will give a fecal and a blood sample that will be used in part 2 to represent the~     oat-avoiding celiac group (group 1).~      In part 2 both celiacs and healthy controls will be recruited and they will be divided into~     three groups: oat-avoiding celiacs (1), oat-consuming celiacs (2) and healthy controls (3).~     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood and a~     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from~     the fecal sample, focusing especially on the amount and diversity of Bifidobacterium genus.~     The metabolic products will be analyzed from the fecal and blood sample using nuclear~     magnetic resonance analysis (NMR). The gut microbiota composition will be analyzed with~     next-generation DNA sequencing techniques.~   "
22568|NCT02761772|"~     Miscarriage is a common event associated with severe psychological and social morbidity,~     further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three~     consecutive losses.~      Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with~     symptoms of threatening miscarriage.~      A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the~     key factor for this prediction ameliorating the implantation process by promoting a~     favorable local immune system in the uterus.~      The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that~     includes women throughout the first trimester by both assisted reproductive technology (ART)~     and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood~     samples of known predictors of implantation PIF as a predictor of viability will be~     evaluated.~      These data are finally compared to the same data in a retrospective cohort of RPL patients~     emphasizing the role of PIF.~      All collected data will be stored in a Research Biobank for the current studies outlined as~     well as potential future studies of reproductive medicine in the first trimester.~   "
22569|NCT02760706|"~     Study hypothesis: Post-processed SDCT images provide additional diagnostic value over~     conventional CT datasets.~      The CT examination would be a clinically-necessary, standard-of-care CT performed as per the~     clinical indication. The protocol and scan parameters for the CT exam will be similar to~     that of an equivalent scan performed with any other CT scanner. There would be no additional~     scanner of injection of any drug specifically for the study. The conventional CT images~     generated by the scanner will be used for clinical purposes as routinely practiced.~   "
22570|NCT02760693|"~     monitoring system and data base for long term follow up of various treatment strategies in a~     naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design,~     prospective & retrospective~   "
22571|NCT02760680|"~     A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic~     device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart~     failure (CHF) and sleep-disordered breathing (SDB).~   "
22572|NCT02760667|"~     The objective of this study is to assess the efficacy of induction chemotherapy followed by~     transoral surgical treatment and neck dissection, in definitive management of moderately~     advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out~     Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary~     tumor, and neck dissection for the management of cervical lymph nodes.~      The primary outcome measure will be disease specific survival (DSS). The secondary oncologic~     outcome measures will be locoregional control, relapse free survival, overall survival, and~     Quality of Life (QOL).~   "
22573|NCT02760654|"~     The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of~     an online cognitive behavioral pain management website called Proactive Self-Management~     Program for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for~     individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to~     explore the mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression,~     and sleep disturbance on worst pain intensity. Another aim of this study is to determine~     whether PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and~     tingling), average pain severity, and physical impairment. Lastly, since this intervention~     has never been tested in individuals with painful CIPN, the investigators will assess~     patients' perceptions of acceptability and satisfaction with the intervention.~   "
22574|NCT02760641|"~     The purpose of this study is to determine the effects of change in diet quality~     (carbohydrate restriction versus fat restriction) on body composition, fat distribution,~     cardiometabolic risk factors, physical function, and quality of life in aging adults with~     obesity.~   "
22575|NCT02760628|"~     The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for~     firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and~     practices. The program was designed by FFs with backgrounds in tactical fitness, marketing~     and program development professionals, and nutrition and exercise scientists. Preliminary~     data suggests the program is well-received by FFs and results in significant improvement in~     body composition and physical fitness. One innovative approach for the eventual~     dissemination of TF20 to VFFs is through their fitness-for duty medical exams. The synergy~     created by linking the TF20 intervention components, feedback to the VFFs from their medical~     exam, and health messages from their physician is predicted to maximize the impact of this~     much-needed intervention. The goal of the proposed project is to tailor TF20 for use in a~     clinic based setting (CB-TF20) for VFFs and to pilot test it in comparison to the American~     Heart Association's Life's Simple 7 (LS7), a web-based diet and physical activity~     knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative~     research with key stakeholders in the VFF community (e.g., physicians, department~     leadership, VFFs) to determine best practices for implementing a clinic-based, web-mobile~     health and wellness program with VFFs and medical providers; 2) Develop a clinic-based~     version of TF20 (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm,~     pilot cluster (i.e., department) randomized clinical trial (PCRCT) to determine the~     comparative effectiveness of the revised CB-TF20 to LS7 on body composition, Framingham Risk~     Scores, and diet/physical activity knowledge and behaviors among VFF with BMI >25.0kg/m2;~     and conduct an evaluation of the CB-TF20 materials and technology. This innovative R34 study~     is a critical step in providing a much needed intervention for VFFs and those providing~     their annual examinations.~   "
22576|NCT02760615|"~     The purpose of this study is to evaluate in a step-wise approach the disease drug-drug~     interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome~     P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with~     ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.~   "
22577|NCT02760602|"~     The main purpose of this study is to investigate the safety and efficacy of the study drug~     solanezumab in participants with prodromal Alzheimer's disease (AD).~   "
22578|NCT02760589|"~     The purpose of the study is a clinical evaluation with special regard to magnetic resonance~     imaging and functional performance at least one year after injury / surgery in all three~     groups (subjects who underwent InternalBrace surgery, subjects who underwent surgery with a~     semitendinosus graft and subjects who were treated conservatively).~   "
22579|NCT02760576|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
22580|NCT02761746|"~     This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, and Washington,~     DC), two-group randomized controlled trial testing a two-session intervention designed to~     increase motivation for adherence to antiretroviral treatment (ART) among youth living with~     HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the~     intervention, Motivational Enhancement System for Adherence (MESA), or the control~     condition, System for Health (SH: healthy eating and physical activity information). Both~     groups receive the standard of care regarding the initiation of ART. ART adherence (visual~     analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts)~     are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence,~     and self-efficacy for adherence) and predictors of intervention response (substance abuse,~     mental health symptoms, executive functioning, and stressful life events) are assessed.~   "
22581|NCT02761733|"~     The primary goal of the proposed study is to investigate the implementation and~     effectiveness of the mPOWR (Moving Patient-centered Outcomes through Wellness and Recovery)~     in diverse urban and rural community mental health settings. The study compares patient~     participation and outcomes using the mPOWR system to a usual care control condition. Four~     community mental health agencies participate in the research: two in San Francisco (urban)~     and two in N.M. (rural). One site in each setting serves as the mPOWR implementation site~     and the other serves as the control site. Service sites were randomly assigned to~     intervention or usual care conditions. A quasi experimental design was used; only eligible~     participants were enrolled in the study (e.g., exclusion criteria of moderate to severe~     cognitive impairment, patient services structured for provision of mPOWR implementation,~     etc.). The study design will employ repeated quantitative measures to assess change in~     outcomes within and across conditions over time. Qualitative methods in the form of focus~     group interviews will also be used to round out the information obtained about patient and~     provider expectations and experiences. Primary outcomes of interest include: Short Form~     Health Survey-12 (SF-12; physical and mental health aspects of health and well-being);~     Outcome Rating Scale (ORS; general well-being, personal well-being, close relationships, and~     work/school/friend relationships); Shared Decision Making Questionnaire (congruence of~     patient's and provider's participation in therapeutic decision making and patient's~     understanding of treatment and treatment options); Working Alliance Inventory (perception of~     therapeutic alliance); and Satisfaction Questionnaire (communication patterns between~     physicians and their patients).~   "
22582|NCT02761720|"~     The Mobile Mood Tracking App study is a small randomized trial of acceptability and~     usability of a mobile phone mood tracking application (mobile app) among women with~     depressed mood in pregnancy. The study will be assessing the perceived value and usability~     of this tool in pregnancy over eight weeks to test whether women using this app are more~     likely to receive assessments and treatments of depressed mood than women not using it.~   "
22583|NCT02761707|"~     This study seeks to establish the sensitivity and specificity of what appears to be a unique~     brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic~     nasotrigeminal reflex response - in differentiating early stage PD from normal controls and~     from patients with various other neurodegenerative diseases. This study will additionally~     compare the biomarker to olfactory testing.~   "
22584|NCT02761694|"~     An open-label, Phase 1, dose escalation study of ARQ 751 in subjects with advanced solid~     tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations or PTEN-null.~   "
22585|NCT02761681|"~     This study will develop and then test a web-based guided self-help version of Acceptance and~     Commitment Therapy (ACT) to be utilized at college counseling centers (CCCs). ACT is an~     evidence-based transdiagnostic therapy found to effectively treat a range of psychological~     problems. An ACT program would provide a means of implementing effective treatment for the~     range of problems in the CCC setting, while the guided self-help format would reduce~     counselors' workload, improving cost-effectiveness and reducing waiting lists. This would~     both treat students and train counselors in how to implement the ACT intervention.~   "
22607|NCT02761395|"~     1. Evaluate the therapeutic effects, health benefits, and immunological effect of~          Al-hijamah in children with beta thalassemia major.~        2. Evaluate the extent of clinical improvement, reductions in serum iron and ferritin,~          antioxidant status, in those patients.~   "
22586|NCT02761668|"~     Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and~     often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is~     required to control the periodontal infection, reconstruct the defects and realign the~     migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a~     topic of ongoing debate.~      There are no data available from RCTs that have compared the effect of the timing of~     orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal~     surgery in these patients.~      It is the aim of the present randomized clinical multicenter trial to compare 2 different~     treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced~     periodontitis patients with intrabony defects and pathologic tooth migration in order to~     establish whether one treatment modality is superior to the other with regard to clinical~     outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups~     that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late:~     6 months following regenerative periodontal surgery).~      Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12~     months after regenerative therapy. Secondary outcomes will include changes in probing depth~     BOP, gingival recession, radiographic bone height and patient-centered outcomes.~   "
22587|NCT02761655|"~     Background and Purpose: Previous studies indicate that baseline cognitive abilities,~     especially prospective memory (PM) significantly influence medication adherence. However,~     there are only three qualified intervention studies on adherences in persons with cognitive~     impairment (PWCIs). In addition, family caregivers (FCGs) are often asked to assist PWCIs in~     managing their medication but FCGs' medication administration hassles are not intensively~     investigated. Therefore, the purpose of this project is to test the effectiveness and~     efficacy of a theoretical-based multifaceted memory intervention on medication~     administration and quality of life in PWCIs living at home and medication administration~     hassle of their FCGs.~      Study Design: This is a three-year project (2015, 8, 1-2018, 7, 31). The aims of the~     first-year study are: 1.to develop a multifaceted memory intervention based on the paradigm~     of prospective memory (PM); 2. to pilot test the feasibility of the multifaceted memory~     intervention through a small randomized control trial. The aims of the second- to third year~     study are: 3. to examine the effectiveness and efficacy of the intervention (a randomized~     control trial). The intervention group will receive a cognitive impairment education,~     medication adherence and memory strategies training, while the control group will receive~     only the cognitive impairment education program. The duration of the intervention is one~     month. There will be 4 data collections (baseline, post-intervention 2 4, 6 months). Sample~     size estimation for the pilot study is 5 dyads for each group. Sample size for the~     randomized clinical trial is 84 dyads (42 dyads per group). After the attrition rate (10%)~     is counted, in total, there will be 200 cases (100 dyads). Implications of this project:~     This three-year program can help to identify those who may benefit from memory training and~     assist those who may be incompetent living in community. Also this program will extend the~     current knowledge of the role of PM playing in medication adherence behavior and its~     relationships with self awareness as well as everyday decision making among PWCIs. In~     addition, health related professionals can improve PWCI's quality of care and reduce FCG~     hassle by applying a theoretical guided practice for memory training.~   "
22588|NCT02761642|"~     This study will evaluate the efficacy and safety of subcutaneous (SC) r-HuEPO in anemic~     participants with breast cancer undergoing chemotherapy.~   "
22589|NCT02761629|"~     This randomized, multi-center, Phase IV, comparative study will assess the efficacy and~     safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48~     or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic~     hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).~   "
22590|NCT02761616|"~     This is a retrospective, and observational cohort study to determine the proportion of~     breast cancer first relapses, that are biopsied. The duration of the study will be~     approximately 24 months.~   "
22591|NCT02761603|"~     Over 30% of American adults have hypertension (HTN) (high blood pressure), and the rate~     increases considerably with age; 64% of men and 78% of women over 65 have HTN. High blood~     pressure associated with HTN can force of the blood against artery walls with enough~     pressure that it can eventually cause health problems, such as heart disease and stroke. HTN~     is one of the most significant causes of early death worldwide and one of the most~     preventable causes of death. Many studies reveal that lowering blood pressure (BP) reduces~     the incidence of diseases of the heart and blood vessels. Non-drug related treatments are~     known to reduce BP which can have a great effect on public health. Research suggests that~     Tai Chi (TC) is effective in lowering BP in patients with HTN, but because of the low~     quality of existing studies there is no definite proof. Also, it is not known how TC reduces~     BP. One possibility is that TC practice, which is shown to reduce psychological distress~     such as anxiety and depression and reduce the body's responses to stress, can improve the~     balance of the autonomic nervous system (the part of your nervous system that controls~     beating of the heart and the widening or narrowing of blood vessels). This may lead to lower~     BP. The investigators plan to investigate the pathways among autonomic, blood vessel, immune~     and psychological factors in relation to BP changes in response to 12-weeks of TC compared~     with Healthy Aging Practice-centered Education (HAP-E). 250 older adults (60+ years old)~     with mild HTN will be enrolled, and the investigators will take several measurements of~     heart and nervous system functioning. The investigators hypothesize that performing TC for~     12 weeks will result in autonomic re-regulation which will improve BP and blood vessel~     health (Aim 1) and sympathetic nervous system (part of the nervous system that serves to~     speed up heart rate, contract blood vessels, and raise blood pressure) regulation of the~     immune system (Aim 2). Lastly, the investigators hypothesize that psychological factors will~     be related to TC effects on autonomic regulation (Aim 3). Findings from the investigators~     study will hopefully shed light on the pathways by which TC reduces BP. Also, the particular~     effects of TC (meditative movement) in an older, hard-to-treat hypertensive population~     will be better understood.~   "
22592|NCT02761590|"~     Introduction: The increase in intermuscular adipose tissue (IMAT) can contribute to muscle~     weakness and consequently on progression of knee OA. The prescription of exercise protocols~     has been used as a treatment strategy to minimize some of the bouts. Circuit training (CT)~     involves the combination of strength training and aerobic in the same session and has shown~     benefits in body composition and physical function. But the literature is unclear with~     respect to the influences of CT in the concentration of IMAT in the population with knee OA.~     Objective: To investigate the influence of a 14-week CT protocol in body composition and~     thigh IMAT concentration as well as cartilage degradation indicators and systemic~     inflammation and its impact on quality of life in patients with knee OA.~   "
22593|NCT02761577|"~     The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients~     with previously normal renal function undergoing angiography and comparison between the~     three different treatment protocols on renal function.~      Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate~     (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.~      Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated~     lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as~     an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72~     hours after the procedure~   "
22608|NCT02761382|"~     This study evaluates the effects of psychological treatment on pain, quality of life and~     work ability among women with endometriosis related chronic pelvic pain in a three-armed,~     randomised study. One group will receive mindfulness-based psychological treatment, the~     second group will receive a non-specific general psychological treatment (a psychological~     placebo) and the third group will be a waiting list control (treatment as usual).~   "
22594|NCT02761564|"~     Current international guidelines suggest a restrictive transfusion strategy, setting that Hb~     level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold~     for all the patients has been challenged by authors, suggesting a more liberal strategy for~     certain cases. At the moment, there is no other parameter considered accurate enough to be~     taken into consideration for transfusion strategy management.~      This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion~     in order to stratify its indication after cardiac surgery.~      Monocentric, randomised, single blind study (patient not aware of the group assignments)~     Patient inclusion will be made in ICU if the physician decides to perform blood transfusion~     according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).~      Every patient will go through randomization to be placed in one of the two groups of the~     study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2~     (group ScvO2), or the control group.~      Our main objective is to evaluate the impact of a new transfusion strategy founded on~     guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells~     transfusion for anemia early after cardiac surgery.~   "
22595|NCT02761551|"~     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,~     only about half of children are vaccinated annually leading to substantial influenza disease~     in children and spread of disease to adults. A major barrier is that families are not~     reminded about the need for their children to receive influenza vaccination. The~     investigators will evaluate the impact of patient reminder/recall (R/R) performed by state~     immunization information systems to improve influenza vaccination rates by using three~     clinical trials in two states. The investigators will assess effectiveness and~     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The~     investigators will disseminate the state immunization information system based~     reminder/recall system to all states for use for both seasonal and pandemic influenza~     vaccinations with the goal of lowering influenza morbidity.~   "
22596|NCT02761538|"~     The investigators developed the Aviitam® online platform. The purpose of the project is to~     test the medico-economic impact related to the utilization of the Aviitam online platform in~     primary care.~      Primary objective: To assess the cost-effectiveness at 24 months follow-up of the~     utilization of the Aviitam® online software in primary care for people with obesity and at~     least one comorbidity compared to a usual follow-up in primary care.~      Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid~     profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling~     of patients and data mining analysis on the collected data.~      Method : Overweight & obese patients with associated comorbidities will receive a 24 months~     follow-up to assess the impact of the use of the online platform Aviitam®.~      Practitioners will be randomized by lot between an Aviitam® group and a control group (usual~     care).~      A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget~     impact analysis.~      With no hypothesis on the primary endpoint, the calculation of the required number of~     subjects was based on the quality of life. 150 patients will be included per group Patients~     of the 2 groups will be assessed at baseline and after 24 months. The first day of each~     month, each patient included in the study will receive a questionnaire to fill online to~     evaluate their health care consumption in the previous month and the EQ5D questionnaire , a~     standardized questionnaire validated in French to assess the effects on health and to be~     used to calculate cost - utility.~      Expected results and perspectives Proving the effectiveness of the Aviitam® online program~     focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity~     management with reduced health costs, improvement in quality of life, reduction in weight~     and improvement of comorbidities.~      In terms of public health, the use of the platform Aviitam® can be expect to improve~     management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a~     valuable tool to support healthcare professionals in outpatient therapeutic education~     approaches.~   "
22597|NCT02761525|"~     The purpose of this study is to determine whether oral topic silver nanoparticles are~     effective to reduce potential pathogen microbial loads in mechanical ventilation patients.~   "
22598|NCT02761512|"~     To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of~     therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral~     administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer~     patients.~   "
22599|NCT02761499|"~     This is a prospective, single arm, multi-center, post-approval study designed to evaluate~     the short and long term clinical performance and safety in subjects receiving primary total~     hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.~   "
22600|NCT02761486|"~     Regular use of aspirin may reduce the incidence of colorectal cancer (CRC). However, it is~     unclear through which mechanism aspirin exerts its effect, in whom it decreases CRC risk and~     in whom it causes side effects. Recently, the imbalanced gut microbiome was linked to~     inflammation and CRC risk. The main hypothesis for this study is that aspirin may decrease~     CRC risk via targeting the gut microbiome. The study will be a randomized placebo-controlled~     double-blinded design, recruiting 50 healthy subjects, 50-75 years old, from the PRospective~     Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area, who will~     receive either aspirin or placebo for 6 weeks.~   "
22601|NCT02761473|"~     Pediatric mastocytosis is an orphan disease, which encompasses several clinically distinct~     entities including solitary mastocytoma, urticaria pigmentosa, diffuse cutaneous~     mastocytosis and the newly recognized mast cell activation syndrome. The most common form of~     pediatric mastocytosis is cutaneous maculopapular mastocytosis (CMPM), also known as~     urticaria pigmentosa (UP). There are significant knowledge gaps regarding the genetic basis~     of pediatric mastocytosis and the functional activity of mast cells in this condition. The~     Pediatric Dermatology and Pediatric Oncology services at the University of Minnesota Masonic~     Children's Hospital are seeing significant growth in clinical volumes of pediatric~     mastocytosis, including rare, familial cases. The aims of this study are to prospectively~     explore germline risk for UP and to perform a mutational analysis to identify somatic~     mutations, beyond those currently identified, in pediatric patients with UP.~   "
22602|NCT02761460|"~     The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in~     preventing chemotherapy-induced neutropenia~   "
22603|NCT02761447|"~     This study evaluates the effectiveness of imagery motor on phantom pain and amputation~     process~   "
22604|NCT02761434|"~     Data from experimental animals and human epidemiological studies have suggested that~     hypohydration and/or low water intake is linked to poor glucose regulation and diabetes. The~     aim of this study is to investigate the effects of cellular dehydration on glucose in~     healthy non-diabetic individuals. METHODS: 60 males and females (30-55 y) will will undergo~     two experimental trials (ISO and HYP), consisting of a 2-h intravenous infusion of isotonic~     or hypertonic saline on two separate occasions, followed by a 4-h oral glucose tolerance~     test. Blood samples were taken from an antecubital vein in 30-min intervals starting at~     baseline for assessment of fluid and glucose regulating factors. Thirst will be assessed via~     visual analog following each blood sample. Energy substrate oxidation will be calculated via~     indirect calorimetry every 60 min.~   "
22609|NCT02761369|"~     The neurobiological underpinnings of obesity point to brain asymmetry in cortical and deeper~     brain regions. Furthermore, chemical, structural and functional imbalance in cortical and~     sub-cortical brain regions alters reward processing, attentional control and self-regulation~     in food-addicted obese individuals. In this study the investigators use TMS with a special~     multichannel H-coil developed by their lab to safely stimulate cortical and deeper brain~     regions in obese humans. The investigators aim to produce interhemispheric neuroplasticity~     (INP) using a paired associative stimulation (PAS) protocol over the DLPFC, to restore~     neurobiological functioning, alleviate food addiction symptoms, and promote weight loss.~   "
22610|NCT02761356|"~     Patients cohort is composed of 50 consecutive patients both male and female with hepatic~     malignancies, refered to our nuclear medicine department in the process of radioembolization~     between January 2010- August 2015. 26 of the patients were examined with Tc99-MAA and~     SPECT-CT and 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Our study~     protocol was as follows:~        1. Collection of anamnestic data~        2. Calculation of liver tumor volume with quantification software~        3. Evaluation of the liver tumor involvement~        4. Evaluation of liver to lung shunt~        5. Calculation dose of SIRTEX~        6. Y90 imaging~        7. Follow Up~   "
22611|NCT02761343|"~     This study will evaluate the feasibility of visualization and characterization of arrhythmia~     ablation lesions by MRI immediately following standard ablation techniques. The appearance~     of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia~     recurrence.~   "
22612|NCT02761330|"~     This study is geared toward characterizing the recovery of brain activity and cognitive~     function following treatments of electroconvulsive therapy and ketamine general anesthesia.~   "
22613|NCT02761317|"~     The study compares the efficacy of bowel cleansing between the standard preparation (2 L~     polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg~     bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with~     previous colorectal resection.~   "
22614|NCT02761304|"~     The reduction in the rate of caesarean section is a major public health issue, it has~     reached 21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth~     increase doubles the risk of fetal morbidity, néonatal and maternal history of when~     césareinne. recommendations for clinical practice (RPC) to scarred uterus are being~     drafted under the auspices of the National College of obstetrics and gynecology (CNGOF) well~     highlighting the health problem public this represents. During 2011, 15% of the 2,700~     patients who have recently given birth to the north of Marseille Hospital were carriers of a~     scarred uterus (internal data).The objective of the obstetrician is to ensure the welfare~     mother and fetus at the end of pregnancy and childbirth. To do this, the realization of a~     work being cesarean allows in some cases to reduce neonatal morbidity related to workflow~     especially in case of abnormal fetal pericardial pace that suggest fetal hypoxia. However, a~     significant number of caesarean section is performed by the side of caution during the~     second part of the work to a suspicion of non-engagement of the fetal presentation. These~     caesareans are indicated, rightly, before a clinical doubt about the height of the~     engagement of the fetal presentation in order to avoid making a difficult instrumental~     delivery, potentially harmful to the mother (perineal tear 3rd and 4th degree) and fetus~     (head injury, intracranial hemorrhage, cephalohematoma). A prospective study published in~     the Lancet estimated 37% error percentage attributable to the clinical examination in case~     of doubt on the commitment of presenatation fœtale. The CNGOF held through PRC publication~     what to do in case of obstetric clinical doubt about the commitment of the fetal~     presentation and not recommended no show against an instrumental extraction in this~     situation (RPC 2008).~      Ultrasound has revolutionized pregnancy monitoring. Its routine use has in other prenatal~     diagnosis of fetal pathologies, it is the other reference screening tool of the most common~     obstetric pathology, preterm labor. Its use became widespread in the delivery room, the~     presence of an ultrasound machine is recommended by the decrees of perinatal care in~     maternity hospitals performing more than 1,500 deliveries per year. It is natural for~     conducting ultrasound during labor has emerged, first to help identify the variety of the~     presentation of the fetal head and then more recently in aid to instrumental delivery.~     Several studies have shown that ultrasound had a sensitivity of commitment over 90% for~     predicting the success of instrumental extraction and a vaginal delivery.~      To our knowledge, to date, there is no study that investigated the benefit of ultrasound~     commitment to reduce the rate of cesarean section during labor. To answer this question, we~     want to show that making a commitment in case of diagnostic ultrasound of doubt about the~     level of engagement of the fetal head (4% of births) reduces by 30% the rate of caesarean~     section fully dilated.~   "
22615|NCT02761291|"~     Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus(EBV) related malignancy and is an~     endemic disease in Southeast Asian countries. EBV had been identified as a therapeutic~     target in some EBV related cancer such as lymphoma and NPC. In cancer cell, EBV was in~     latent phase and expressed 8-11 genes for maintaining EBV proliferation. After switching to~     lytic phase, almost all the EBV encoding genes were expressed including thymidine kinase~     (TK) and some highly immunogenetic genes. These latent-lytic phase swifter included DNA~     methyltransferase inhibitors, various histone deacetylase (HDAC) inhibitors, radiotherapy~     and chemotherapy. Recently, combined chemotherapy and viral lytic therapy, cytolytic viral~     activation therapy (CVAT) had been shown some promising result in pilot study of NPC. In our~     patient derived xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM)~     was shown to be the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) +~     ganciclovir (GCV) maintaining chemotherapy may benefit but reduce chemotherapy related side~     effect and prolonging treatment response duration. The following phase I clinical trial will~     be proposed to test the optimal combination of these drugs.~        1. Number of patients: total 18 patients are needed~        2. Inclusion criteria:(1) used as 2nd line regimen in recurrence/metastasis NPC patients~          with tissue proved of World Health Organization (WHO) type II or type III.(2)~          Performance status: eastern cooperative oncology group performance status (ECOG PS) ≤2.~        3. Chemotherapy regimen: Gemcitabine (GEM, TTY) + Valproic acid (VPA, generic medicine)~          for viral activation + Valganciclovir (VGC, Roche) for antiviral medication~        4. This treatment cycle of 28 days was repeated maximum 6 times. (Q4wks/cycle, max: 6~          cycles)~        5. Dosage:~      (1) GEM: 600, 800, 1000, 1250 mg/m^2, D1 & D8, intravenously. (2) VPA 12.5 mg/kg/day D1~14,~     per os. (3) VGC (2-3) x 450 mg/day D9~15, per os. 6. Objectives:~        1. primary: to find the best combination of these 3 drugs in recurrent/metastatic NPC~          patients.~        2. second: to evaluate the response and disease control rate in this pilot study.~      Key words: NPC, cytolytic viral activation therapy, gemcitabine, valproic acid, ganciclovir.~   "
22616|NCT02761278|"~     The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium~     of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and~     HOXA11 are well-established markers of implantation. It is uncertain as to whether an~     endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and~     HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo~     implantation.~   "
22617|NCT02761265|"~     Surgical intervention may provide pain relief and improvement in function but one area of~     significant clinical interest is the restoration/improvement in gait and functional balance.~     Based on the investigators knowledge, there is limited literature on biomechanics and~     neuromuscular control of the lower extremities and spine as assessed by objective gait~     analysis and balance strategies in adult degenerative scoliosis patients, pre and post~     surgical intervention. The purpose of this study is to determine the impact of spinal~     deformity on the biomechanics and neuromuscular control of the lower and upper extremities,~     and also investigate the impact of surgery on these functions as evaluated by gait and~     balance analyses using dynamic EMG, video motion capture and force plate analysis and also~     to compare these patients with healthy controls to better evaluate the extent of limitations~     before and after surgery.~   "
22618|NCT02761252|"~     The purpose of this study is to compare concomitant administration of Montelukast and~     Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma~   "
22619|NCT02761239|"~     The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN)~     and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human~     cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the~     laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during~     thyroidectomy with intraoperative neuromonitoring (IONM).~   "
22620|NCT02761226|"~     Implants have become the preferred method of single tooth replacement these days, patients~     receiving implant treatments not only expect restoration of masticatory function, they also~     expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To~     maintain long-term implant stability, it is important to minimize bone loss around the~     implant, as well as the soft tissue atrophy that accompanies it.~   "
22621|NCT02761213|"~     The aims of the present study is to compare oral sulfate solution (OSS) with low-dose~     polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.~   "
22633|NCT02761057|"~     This randomized phase II trial studies how well cabozantinib-s-malate, crizotinib,~     volitinib, or sunitinib malate work in treating patients with kidney cancer that has spread~     from where it started to nearby tissue or lymph nodes or to other places in the body.~     Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
22622|NCT02761200|"~     This exploratory study is designed to ensure the safety of HIV-infected volunteers who~     complete research protocols that include an analytic treatment interruption (ATI). This is a~     prospective cohort study of volunteers who were diagnosed with HIV during early acute HIV~     infection, treated with antiretroviral therapy (ART) and subsequently enrolled in a clinical~     study that included ATI. After completion of study participation that involves ATI,~     participants will be recruited into this study for continued clinical and laboratory~     monitoring.~   "
22623|NCT02761187|"~     The purpose of this study is to describe contemporary, real-world disease and participant~     presentation, therapies, and clinical outcomes in both participants with newly diagnosed and~     not yet relapsed [ND] multiple myeloma (MM), and participants with relapsed/refractory [R/R]~     MM.~   "
22624|NCT02761174|"~     The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced~     inflammation in terms of redness, swelling and pain in patients with facial vascular lesions~     (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated~     one month after final IPL-treatment.~      The hypothesis is that brimonidine, which has been proved effective in reduction of~     symptomatic erythema in patients with rosacea, also may have the ability to reduce~     IPL-induced erythema. Since the potential reduction in erythema is caused by~     vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.~   "
22625|NCT02761161|"~     The overall aim of this study is to examine the effects of sleep enhancing treatment in~     refugees with PTSD.~   "
22626|NCT02761148|"~     White matter hyperintensity (WMH) has been found to be related with cognitive and emotional~     dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a~     large-scale brain network, thereby impairing the brain's ability to integrate the neural~     processes efficiently. It is not yet clear, what the pattern of brain network disruption~     relates to WMH and how the brain network disruption induced by WMH has an effect on~     cognition and emotion performance. Using multi-model magnetic resonance imaging (MRI)~     techniques, we aimed to explore the mechanisms of cognitive decline and depression related~     with brain network dysfunction in patients with WMH, and to provide objective imaging marker~     for early diagnosis and prevention of WMH associated cognitive decline and depression.~   "
22627|NCT02761135|"~     Prostate cancer is the most common cancer among men in Sweden. During investigation of~     suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to~     diagnosis.~      The most common technique today is side-fire where the needle enter the prostate in angle~     from the probe. In end-fire technique the needle enters the prostate at tip of probe without~     angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach~     the ventral and apical aspects of prostate.~      Today´s standard is at least five cores from each side of the prostate at first biopsy. If~     first sample is negative there will usually be another urological exam and a first~     re-biopsy.~      The study aim to compare these two methods in cancer detection. The investigators'~     hypothesis is that when using end-fire technique at first re-biopsy, investigators find more~     cancers compared to side-fire.~      Patients are prospectively randomized into two groups, both assessing 12 core biopsies~     according to study protocol.~      Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level,~     prostate size, digital rectal exam, hypoechogenic zones and length of cancers.~   "
22628|NCT02761122|"~     Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration~     of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and~     associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes~     toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at~     Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive~     lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant~     peptide of Human Papilloma Virus (HPV) 16.~      In line with this recent work which shows for the first time a link between HPV-16 and an~     autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis~     that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such~     as non erosive lichen planus or lichen sclerosus.~   "
22629|NCT02761109|"~     Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver~     transplantation are not well defined. Blood products requirement is an important aspect of~     orthotropic liver transplantation (OLTx) management and has a great impact on patient's~     outcome. Transfusions of blood products increase perioperative complications and reduce~     graft and patients survival.~      The primary endpoint of the study is to evaluate the incidence of renal complication during~     ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate~     the incidence of cardiovascular and pulmonary complications. In addition patients' survival~     and the relationship between blood components use with the development of post-operative~     complications are evaluated.~   "
22630|NCT02761096|"~     The aim of this study is to evaluate the effect of acupuncture on inflammation and immune~     function after craniotomy. This study will be a single-center, parallel group clinical trial~     that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.~   "
22631|NCT02761083|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with standard suture material used in Ophthalmic surgery. In order to show that,~     various safety and efficacy parameters have been selected. The outcome regarding these~     parameters will be compared in 2 treatment groups. Active control group will receive Vicryl®~     Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to~     design this study as a randomized trial, because limited clinical evidence is available in~     the literature for the active control group (Vicryl® Rapide) which can be used for~     comparison. Eye operation will be randomly allocated on the left and right side (1:1) to~     both treatment groups.~      Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion,~     entropion, ptosis, eyelid tumor resection, blepharoplasty)~   "
22632|NCT02761070|"~     The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide~     (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or~     progression, comparing to bevacizumab alone.~   "
22649|NCT02760836|"~     The purpose of this study is to develop and validate a predictive model of clinical outcomes~     based on the results of web-based self-reporting symptom diary for Crohn's disease.~   "
22634|NCT02761031|"~     This study will record patient electrocardiograms - as well as various other body signals~     (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored~     routinely both during and immediately subsequent to surgical operations performed under~     general anesthesia. Through retrospective analysis of patients' heart rate variability~     (HRV), in concert with the other abovementioned parameters, the investigators seek to~     forward the development of novel mathematical models and tools for on-line detection of~     cardiovascular and autonomic dysfunction in the perioperative setting.~   "
22635|NCT02761018|"~     The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as~     being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use~     a fitness tracker but will not be able to see other participants data and group 2 will use a~     fitness tracker and will be able to see other members daily and weekly results. Outcome~     measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c,~     weight, body mass index, blood pressure, and number of hours and days fitness tracker is~     used. The goal is to see if the group randomized into an online community will have improved~     activity and outcome measurements compared with those who use the pedometer alone.~   "
22636|NCT02761005|"~     Patients infected with H. pylori are treated with the individualized regimen which is based~     on the mutation of 23S rRNA of H. pylori.~   "
22637|NCT02760992|"~     The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve~     as a temporary substitute for an oral regimen.~   "
22638|NCT02760979|"~     This study evaluates the effect of Denosumab in decreasing the periprosthetic bone~     resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and~     30 Denosumab) within a year after surgery.~   "
22639|NCT02760966|"~     Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the~     complication rate in the newborn.~   "
22640|NCT02760953|"~     The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as~     an adjuvant therapy with TUR to treat bladder tumor.~   "
22641|NCT02760940|"~     Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory~     bowel disease, and it accounts for significant loss in the quality of life of these~     patients. The aim of the current study is to assess the effect of orally administered iron~     treatment, as well as its response predictors in patients with inflammatory bowel disease~     who are in remission and present anemia. The study will recruit 100 patients with Crohn's~     disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored~     in the Inflammatory Bowel Disease Center at the University Hospital of the Federal~     University of Juiz de Fora, for clinical, hematological, biochemical and immunological~     assessment. Blood samples will be collected (10 ml) and the following tests will be~     performed in all the anemia patients (in remission) at the beginning of the treatment and 8~     weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular~     hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte~     sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin,~     quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In~     addition, quality of life, anxiety and depression and fatigue questionnaires will be applied~     to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will~     be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl~     for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe~     anemia. Patients with mild and moderate anemia in remission will be initially treated with~     oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron~     intolerance will be assessed, as well as the patients' disease activity level and quality of~     life. The patients in follow-up will be subjected to new laboratory tests after the eighth~     oral iron treatment week. The results of the current study are expected to help assessing~     the oral iron efficacy and response predictors, as well as the side effects of the treatment~     and its impact on the quality of life of patients.~   "
22642|NCT02760927|"~     Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with~     Oral Endotracheal Tubes with Subglottic Suction~   "
22643|NCT02760914|"~     The aims of the present project are to study possible differences in inflammatory gene~     expression and protein secretion in various compartments of adipose tissue being exposed~     during open cardiac surgery in patients with coronary heart disease undergoing coronary~     artery bypass surgery.~   "
22644|NCT02760901|"~     Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief~     dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose~     cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC)~     ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the~     protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.~      Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin~     nephrotoxicity in humans compared to mannitol and to each other.~      Patients and methods. A total 52 patients receiving standard hydration measures for~     cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients~     receiving acetazolamide and 17 patients receiving NAC. Patients` kidney function was~     monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney~     injury was assessed using RIFLE criteria. Patients` liver function tests and hematological~     parameters were also monitored.~   "
22645|NCT02760888|"~     The purpose of this study is there difference between the effect of Tramadol orally and~     Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in~     nulliparous women.~   "
22646|NCT02760875|"~     Using a population of patients from another study, who was originally randomized to 2~     different types of nonoperative treatment after an acute achilles tendon rupture, the length~     of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed,~     4-5 years after the injury.~   "
22647|NCT02760862|"~     Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower~     abdominal and pelvic surgery under spinal anesthesia were included in this randomized~     double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received~     intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received~     intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours.~     Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of~     treatment was assessed using visual analog scale.~   "
22648|NCT02760849|"~     The goal of this clinical research study is to compare the changes in female sexual function~     between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those~     having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations.~     Researchers also want to learn how these surgeries affect your quality of life.~      RRSO is the standard surgery for patients with certain types of genetic mutations, where the~     fallopian tubes and ovaries are removed at the same time.~      ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a~     second, later surgery. Most women with genetic mutations will be encouraged to remove the~     ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be~     made with your doctor.~   "
22652|NCT02760797|"~     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,~     pharmacodynamics and therapeutic activity of emactuzumab and RO7009789 administered in~     combination in participants with advanced solid tumors. This study will be conducted in two~     parts: dose escalation stage (Part 1) and an expansion stage (Part 2).~   "
22653|NCT02760784|"~     A total of 56 patients completed a previous study regarding non-operative treatment for~     acute achilles tendon rupture. This study consists of an additional follow up after 4-5~     years depending on original date of injury.~   "
22654|NCT02760771|"~     Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty~     (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the~     induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims~     at facilitating the crossing of the aortic annulus, accurate valve positioning and does also~     provide information on the anatomy of the valve complex. However, BAV has been shown to have~     a number of potentially detrimental effects.~      There is limited experience for the balloon expandable Edwards THV on the need for~     predilation (BAV). Experience so far has only been documented from smaller, uncontrolled~     case series.~      The investigators aim to document the incidence of several kinds of complications in a~     large, multicenter registry / prospective controlled cohort study to identify associations~     between patient related variables and outcomes.~   "
22655|NCT02760758|"~     This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor~     (NNI) in healthy volunteers and HCV infected individuals~   "
22656|NCT02760745|"~     Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial~     Infection (SBI). Research supporting this assumption is scant. The purpose of this study is~     to describe the frequency of febrile shivering in the pediatric population arriving at the~     emergency department and to define its role in predicting a SBI.~   "
22657|NCT02760732|"~     This study was to investigate the effect and safety of drug eluting balloon combined for~     treatment of unstable angina.~   "
22658|NCT02760719|"~     This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with~     salbutamol in the treatment of children under 2 years, hospitalised for acute viral~     bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution~     with salbutamol three times daily, the other half will receive standard supportive care,~     which is the cornerstone of the bronchiolitis management.~   "
22659|NCT02760563|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
22660|NCT02760550|"~     The objectives of this policy-related survey are as follows:~      i. to study updated trend and prevalence on secondhand smoke, smoking-attributed health~     effects, cessation services; ii. to investigate the level of public support on current and~     future tobacco control measures and taxation policies; iii. to address the timely impacts of~     smoke-free policies, substantiate public support on further tobacco control measures and~     assist Hong Kong Council On Smoking and Health (COSH) in shaping policy direction for~     government.~      Purpose of the study is to provide evidence and support for smoke-free policy development in~     Hong Kong.~   "
22661|NCT02760537|"~     The study was conducted between April 2013 and October 2014. In the parent study, 600~     foreign-born Asian American adults 18 years of age and older were drawn from the community~     in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method,~     foreign-born Asian American adults, 18 years of age and older, were recruited from the~     community.~      After providing informed consent, all the participants were asked to complete a~     self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the~     assistance of a bilingual interviewer when necessary. Then, all of the participants were~     instructed and given 5 to 10 to minutes to read culturally integrated and linguistically~     appropriate educational material (e.g., Photo novel) developed and validated for efficacy~     from a prior study.~      All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb~     (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600~     completed the survey and screening. A week later, they received the results of the screening~     test. Based on the screening results, all participants were categorized into three groups:~     (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We~     sent the results by mail to participants who were unprotected and protected. Among those 600~     screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335~     (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were~     susceptible to HBV infection (unprotected).~      LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were~     randomly assigned to either the intervention (n=124) or the control (n=108) groups by~     computer-automated random assignment. Randomization was used to assure equivalence between~     groups on key factors that may potentially influence the outcome of HBV vaccinations:~     gender, age, education, length of stay in the U.S.~      LHWs conducted phone interventions by reminding participants of a series of vaccinations at~     months 1, 2, and 5 among those assigned to the intervention group. Those in the control~     group received a list of resources along with their results by mail that offered free~     vaccinations, such as local health departments. Seven months after mailing the results,~     those unprotected were followed up by phone to ask about their status of the series of~     vaccinations and about promoters or barriers to vaccinations.~   "
22662|NCT02760524|"~     The major goal of this study is to determine whether Neuro-Emotional Technique is a viable~     treatment option for decreasing distress in cancer patients. The potential advantages of NET~     are: 1) it is designed specifically to address distressing stimuli and unresolved emotional~     memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may~     appeal to and benefit a broader range of patients than a single mode intervention~   "
22663|NCT02760511|"~     Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the~     epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently,~     study of anthocyanin pigments has drawn more and more interest since several epidemiological~     studies have demonstrated their health-promoting properties, such as reducing lipid~     accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a~     clear need for advancing understanding with regard to effective amounts of intake for these~     phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics~     of anthocyanin in healthy volunteers.~   "
22664|NCT02760498|"~     To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal~     or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally~     advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central~     review.~   "
22665|NCT02760485|"~     The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib~     in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell~     lymphoma (DLBCL)~   "
22681|NCT02760277|"~     The main purposes of this study are to see if it is safe to use a new medication called~     vamorolone for more than two weeks in children with Duchenne muscular dystrophy (DMD), to~     see if vamorolone works for the treatment for DMD, and to see how any potential side effects~     compare to those seen in boys using steroids.~   "
22666|NCT02760472|"~     Most fatty acids, important for development and especially the Omega-3 fatty acids for the~     brain development are transferred in the third trimester with means that in the premature~     infant this transport via the placenta is interrupted and the infant is dependent on the~     concentrations in breast milk which vary depending on the mother's diet and her stores. It~     has even been suggested that low Omega-3 would be a cause of premature delivery. Many~     countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden~     and breast milk substitutions are generally now supplemented with the Long Chained Poly~     Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen~     to give any risks for the infant. On the contrary, several studies have shown that mother~     who eat equal to or less than twice fish a week during pregnancy give birth to infants with~     impaired development.~      Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be~     one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3,~     Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP~     by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels~     to within physiological range may prevent development of ROP.~   "
22667|NCT02760459|"~     To compare the effects of perioperative intravenous Dexamethasone with a placebo on the~     severity of persistent postsurgical pain after total knee arthroplasty.~   "
22668|NCT02760446|"~     Validity and Reliability of French Version of the Confusion Assessment Method for the~     Intensive Care Unit (psychometric validation study after translation/back translation~     process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)~   "
22669|NCT02760433|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to treatment with an existing medication called a tumour necrosis factor alpha~     inhibitor~   "
22670|NCT02760420|"~     The purpose of this study to assess the effectiveness of no antibiotic treatment for fast~     breathing, community-acquired childhood pneumonia in a malaria-endemic region of Malawi.~   "
22671|NCT02760407|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to treatment with methotrexate (MTX).~   "
22672|NCT02760394|"~     Hyperbaric oxygen therapy (HBOT) is proposed as a possible in vivo angiogenic stimulator for~     improving microvascular myocardial perfusion and anginal symptoms as assessed by myocardial~     perfusion imaging and angina questionnaire in patients with chronic stable ischemic heart~     disease, when no other means to relief symptoms and/or ischemia are available.~   "
22673|NCT02760381|"~     Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the~     colon. Currently all polyps should be resected endoscopically, however adenomas have the~     potential to develop into colorectal cancer whereas hyperplastic polyps do not. This~     approach enables the lesions to be evaluated under the microscope. Currently only the~     pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps.~     Acetic acid (AA) chromoendoscopy is already widely used in order to improve optical~     determination of mucosal lesions in the upper gastrointestinal tract. In the colon only few~     studies investigated the impact of AA in differentiating normal mucosa from suspicious~     mucosa. The aim of the present study is to evaluate the value of spraying acetic acid as an~     adjunct for optical characterization of colon polyps. Using AA may be beneficial for~     determining optical diagnoses of colon polyps during real time colonoscopy. This is a~     single-arm proof of principle study. If colon polyps are found during colonoscopy a 1.5~     percent AA solution will be used for chromoendoscopy. Endoscopists are encouraged to use the~     Narrow Band Imaging (NBI) function of the endoscope prior to the use of AA. After AA is~     sprayed endoscopists will diagnose the polyp optically. Endoscopists have to predict~     adenomatous or non-adenomatous histology based upon optical features of the polyp. All~     polyps will be resected endoscopically so that histopathological diagnoses can be~     determined. After completing the trial the investigators aim to compare optical and~     histopathological-based diagnoses of polyps. Histopathological diagnoses will serve as the~     gold standard. Based upon this information the accuracy of the optical diagnoses will be~     calculated. The investigators hypothesis is, that optical-based diagnosis using NBI and AA~     will be accurate in > 75% of all polyp cases.~   "
22674|NCT02760368|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to, treatment with methotrexate (MTX).~   "
22675|NCT02760355|"~     In this pilot study, the investigators plan to treat patients with chronic hepatitis C due~     to HCV genotype 3 infection using an interferon-free regimen consisting in the~     administration of ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA~     polymerase inhibitor with a non-structural protein 5A inhibitor. Patients will undergo a~     euglycemic hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether~     the viral suppression induced by this regimen will be capable of reversing the glucose~     metabolic alterations induced by HCV in both the liver and extrahepatic compartments.~     Adipose and muscle tissue biopsies will also be performed to assess some specific molecular~     changes induced by HCV.~   "
22676|NCT02760342|"~     The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K~     and metformin in healthy non-elderly male subjects.~   "
22677|NCT02760329|"~     The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of~     obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal~     cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma~     and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical~     assessments and receive standard medical care as determined by their treating physician.~     Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a~     total duration of three years. In addition, patients will be followed up remotely every 3~     months. The NOVELTY study will collect data currently lacking to allow for multinational~     data collection to fill regional/local gaps and improve comparability across regions.~   "
22678|NCT02760316|"~     A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending doses of AZD9567.~   "
22679|NCT02760303|"~     Adolescence and young adulthood may be particularly stressful developmental periods due to~     the numerous transitions into new roles and the need for increased independence. Stress can~     affect metabolic control in older adolescents and young adults with T1D directly through its~     impact on cortisol and other hormones that affect insulin metabolism.~      The proposed study is a pilot randomized clinical trial using a three-group randomized,~     repeated measures design to assess the efficacy of two treatments (Mindfulness Based Stress~     Reduction (MBSR) and Cognitive Behavioral Therapy or (CBT) versus an attention control~     condition for older adolescents and young adults with poorly controlled Type 1 diabetes. As~     a pilot study, the goal of the research is to test recruitment and retention procedures,~     finalize intervention measures, training, and fidelity protocols, and estimate effect sizes~     for a larger clinical trial.~   "
22683|NCT02760251|"~     The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist~     (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became~     intolerant to it. It is hypothesized that the early phase of this autoimmune disease may~     exhibit a stronger immunomodulatory potential in response to a stimulus, such as~     romiplostim. Such a process may subsequently be capable to induce regulatory mechanisms or~     tolerance.~      Romiplostim (a thrombopoietin-receptor agonist, TPO-RA) will be administered subcutaneously~     once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. The dose will be~     adjusted based on platelet counts as described in the summary of Product Characteristics~     (SmPC).~   "
22684|NCT02760238|"~     The mandate of this MPN registry is to collect clinical information, including molecular~     results, from consenting patients with a variety of MPNs at different time points during the~     course of their disease.~   "
22685|NCT02760225|"~     This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer~     89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a~     registered indication: locally advanced metastatic melanoma or non-small cell lung cancer~     before Pembrolizumab treatment.~   "
22686|NCT02760212|"~     Fibromyalgia is a common disorder affecting approximately 2% of the Canadian population.~     Patients diagnosed with fibromyalgia commonly present with chronic, widespread pain as well~     as fatigue, depression, mood disturbances, and cognitive symptoms. As a result, fibromyalgia~     has a negative impact on the patient's quality of life, and a negative financial impact for~     them, society, and the healthcare system, through lost wages and delayed diagnosis.~     Therefore a more direct and conclusive method of diagnosis is needed.~      Recently, fibromyalgia diagnosis has been based on the modified American College of~     Rheumatology Preliminary Diagnostic Criteria for fibromyalgia. To assist with diagnosis,~     recent evidence shows that compared to healthy people, people with fibromyalgia present with~     differences on functional MRI (fMRI) whole brain scans, as well as differences in a~     functional blood biomarker challenge test, known as fm/a. The fm/a determines the function~     of the immune system in response to a stimulus, and has been used previously to show that~     people with fibromyalgia have a severely blunted immune response.~      Despite the number of treatment options available, interventions for chronic pain remain~     largely ineffective. In light of its demonstrated effectiveness, safety, and ease of use in~     previous studies, radial shockwave therapy (RSWT) has been selected for inclusion in the~     present study. The main objective of this study is to determine the efficacy and effect of~     RSWT compared to placebo on the symptoms frequently reported in association with~     fibromyalgia. In addition, the fm/a and brain activity associated with pain patterns (fMRI)~     may assist in early diagnosis and prediction of treatment success in patients with~     fibromyalgia.~   "
22687|NCT02760199|"~     AMG 211 is a bispecific single-chain antibody construct of the bispecific T-cell engager~     (BiTE®) class that targets human carcinoembryonic antigen (CEA, CD66e) on (tumor) cells and~     cluster of differentiation 3 (CD3) positive T-cells. AMG 211 is a potentially new targeted~     drug in the treatment of relapsed/refractory gastrointestinal adenocarcinoma, since those~     are CEA expressing tumors. A well-known challenge in current drug development using targeted~     therapies is the high level of heterogeneity of target expression that is present in~     specific tumor types. Radio-labeling of AMG 211 with the positron emission tomography (PET)~     radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of AMG 211~     distribution in cancer patients. By performing a 89Zr-AMG211 PET scan prior to treatment~     with AMG 211, the uptake of the tracer in the primary and metastatic tumor lesions and~     normal organ distribution can be evaluated. By performing a 89Zr-AMG211 PET scan during AMG~     211 continuous intravenous (cIV) treatment the investigators will be able to evaluate the~     impact of prolonged steady state exposure of AMG 211 on tumor and tissue uptake. The~     89Zr-AMG211 PET imaging study may help to identify patients more likely to benefit from AMG~     211 therapy.~   "
22688|NCT02760186|"~     Prospective interventional trial in lowlanders evaluating effect of acute exposure,~     acclimatization and re-exposure to high altitude.~   "
22689|NCT02760173|"~     The long-term goal of this research is to advance our knowledge of how the brain combines~     the information of multiple sensory systems coding for spatial orientation and how~     adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects~     verticality perception is accurate while upright. After prolonged roll-tilt, humans show a~     systematic bias in perceived direction towards the previous roll-tilted position (so-called~     post-tilt bias). Here we evaluate different potential explanations for this bias using~     both vision-dependent and vision-independent paradigms of verticality perception.~   "
22690|NCT02760160|"~     To assess the effect of orally administered grape powder on the sunburn reaction in humans.~   "
22691|NCT02760147|"~     The aim of this study is to evaluate the ventilator settings advice given by the BEACON care~     system in fitting with best level of support in patient under mechanical ventilation in~     Pressure Support mode.~   "
22692|NCT02760134|"~     Percutaneous nephrolithotomy (PCNL) is a well-established treatment modality for renal~     stones. It offers a high stone free rates and less invasive than open surgery. Nevertheless~     PCNL is an invasive and technically demanding procedure with inherent risks and~     complications. The most troublesome morbidities are bleeding and injury to the kidney and~     its adjacent structures. Complications of PCNL tend to be associated with the accuracy of~     tract placement and the size of the nephrostomy tract. To improve the safety of PCNL, there~     is a trend toward using smaller and smaller nephrostomy tracts . With the smaller~     nephrostomy tract, there also arise the problems of compromised visual field and increased~     difficulty in stone extraction. Increase irrigation using pressure pump might improve the~     visualization and the passive egress of the stone fragments, but it also may concomitantly~     increase the intra-luminal pressure.~      The present system of Super-Mini percutaneous nephrolithotomy (SMP) was developed to address~     many of these deficiencies. The basic components of SMP system are an 8.0 F miniaturized~     nephroscope with a newly designed irrigation-suction sheath with enhanced irrigation~     capability and modified nephrostomy sheath with continuous negative pressure aspiration. Its~     design was intended not only to prevent the excessive intrarenal pressure but also improve~     the visualization and the stone fragments extraction.~      Little was known about renal pelvic pressure in vivo during SMP and about any correlation it~     might have had with postoperative fever and urosepsis. We measure the renal pelvic pressure~     during SMP to determine whether it will improve the renal pelvic pressure and improve the~     incidence of postoperative fever.~   "
22693|NCT02760121|"~     The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ)~     and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction.~     The first objective is to assess the effects of AZ and MZ on the control of breathing in~     normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon~     dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In~     addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic~     ventilatory response will be measured with each drug. The second objective is to assess the~     effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary~     pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.~   "
22694|NCT02760108|"~     One person in every 500 has Parkinson's and around 127,000 people are living with the~     condition in the UK. The aim of the study is to identify new genes that predispose or cause~     Parkinson's Disease or Parkinsonism. There is a pressing need to study the genetic makeup of~     family members both with and without Parkinson's. As families share a common genetic~     background, it is easier to find new Parkinson's genes by studying the genetic makeup of~     people with Parkinson's alongside other members of their families. We are particularly~     interested in studying the genetic makeup of two groups of people:~        1. those who developed Parkinson's before the age of 45; and~        2. those who have a family history of other relatives affected by Parkinson's.~      By identifying genetic factors that cause Parkinson's, we hope to understand more about the~     condition. Doing so will lead to the development of better diagnosis, improved disease~     models, and we hope in time, to the development of better treatment.~   "
22695|NCT02760095|"~     The overall objective is to determine the impact of EED on zinc absorption and homeostasis,~     and its impact on the absorptive capacity of vitamin A absorption of young children (18-24~     months of age) in an austere setting with high rates of diarrhea, stunting, and~     micro-nutrient deficiencies.~   "
22696|NCT02760082|"~     The study will based on qualitative methods investigate motivational factors among patients~     diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress~     provoking factors and physical activity (NESPA). The aim is to gain knowledge on~     motivational factors for using a digital tool for collecting data on NESPA and incorporate~     this knowledge into a form which can be used in requirement specifications for such a~     digital tool.~   "
22697|NCT02760069|"~     This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with~     three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl~     alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.~   "
22698|NCT02760056|"~     This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine~     (T3) in subjects with multiple sclerosis~   "
22699|NCT02760043|"~     This study will evaluate if the addition of dexamethasone to a local infiltration analgesia~     mixture will improve functional outcomes following total hip and knee arthroplasty.~   "
22700|NCT02760030|"~     This phase II clinical trial studies how well fulvestrant and palbociclib works in treating~     older patients with breast cancer that responds to hormone treatment (hormone responsive)~     that cannot be removed by surgery. Estrogen can cause the growth of~     estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight~     estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells.~     Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for~     hormone responsive breast cancer.~   "
22701|NCT02760017|"~     Among the plants most used in folk medicine for the treatment of diabetes are the species of~     the genus Bauhinia (Fabaceae), popularly known in Brazil as pata-de-vaca. Of these,~     Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity.~     Due to this fact it is included in the Medicinal Plants List of the Brazilian Public Health~     System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its~     chemical composition and its pharmacological potential. From the chemical point of view the~     main components identified in hydro alcoholic extract of the leaves are O-glycosylated~     derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical~     studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic~     extract of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic~     activity of B. forficata in clinical level was performed in only two studies, both with few~     patients, and questionable methodological quality that used tea as a pharmaceutical form, a~     fact that allows us to question the validity of data considering the risks of no dose~     reproducibility ingested by patients during the study. Thus the investigators here intend to~     determine the effects of a standardized extract of B. forficata in the control of patients~     with diabetes mellitus~   "
22702|NCT02760004|"~     The primary goal of this study is to develop, evaluate, and share a new low-cost program for~     Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for~     women during pregnancy and after childbirth.~   "
22703|NCT02759991|"~     The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in~     women of child bearing age in preventing HEV disease during pregnancy among women in rural~     Bangladesh.~   "
22704|NCT02759978|"~     Infective endocarditis (IE) is a frequent and serious complication of implanted intracardiac~     prosthetic material, with a high morbidity and mortality. Therefore, this study aims to~     improve outcome of IE, with a focus on patients with intracardiac prosthetic material. In~     this study the investigators deal with research questions about both the diagnosis~     (microbiological, imaging, and expert opinion) and treatment of IE (with antimicrobial~     agents and surgical), in order to improve these clinical components and ultimately aim to~     improve outcome.~   "
22705|NCT02759965|"~     The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within~     48 hours after elective hip surgery and that there is an association between exaggerated CNS~     inflammatory response or impaired inflammatory resolution and postoperative cognitive~     dysfunction within one week and at three months postoperatively.~   "
22706|NCT02759952|"~     Mutations in the PDE6A gene - encoding the -subunit of the rod cGMP-phosphodiesterase -~     account for 1% of autosomal recessive retinitis pigmentosa (arRP) through impaired~     regulation of cGMP levels in the rod outer segment. This study aims for a detailed clinical~     characterization of patients with PDE6A mutations in preparation of a clinical gene~     replacement study (phase I/II safety trial).~   "
22707|NCT02759939|"~     Right For Me is a study that aims to improve the conversations patients and health care~     providers have about birth control. Right For Me will test two different strategies for~     improving these conversations. The first strategy is to give patients a video to watch that~     encourages them to ask three specific questions in their health care visit, as well as a~     prompt card that reminds them of the three questions. The second strategy is to give health~     care providers a set of decision aids that describe available birth control methods, as well~     as training in how to use them with patients during the health care visit. Right For Me will~     test whether introducing one or both of these strategies leads to better conversations than~     providing health care as usual.~   "
22708|NCT02759926|"~     In this study, the investigators aimed at evaluating the role of bitter taste receptors in~     the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium~     benzoate (DB) or quinine hydrochloride were compared with placebo administration for their~     effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed~     state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and~     cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be~     evaluated.~   "
22709|NCT02759913|"~     Prospective multicenter study of subjects who were recently diagnosed with amyotrophic~     lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord~     diseases, muscle diseases and neurological diseases such as multiple sclerosis, multifocal~     motor neuropathy, myasthenia gravis and spinal muscular atrophy) or who are currently~     undergoing diagnostic procedures for the aforementioned diseases.~      Approximately 300 subjects will be enrolled. Subjects will undergo a lumbar puncture (LP)~     for cerebro-spinal fluid (CSF) collection; blood collection for serum, plasma, RNA, and DNA~     (optional); urine collection (optional); and skin biopsy (optional) in a single visit. No~     study treatment will be administered.~      Subjects will be managed and treated by their respective physicians; choice of therapy or~     laboratory tests will not be impacted by the study. Clinical diagnosis may be confirmed by~     the subject's physician and communicated to the study's Principal Investigator (PI) by~     scheduled telephone calls.~   "
22710|NCT02759900|"~     This study examines the efficacy of a non-thermal, atmospheric plasma device in the~     treatment of a number of different skin disorders~   "
22711|NCT02759887|"~     In order to treat individuals with Down syndrome (DS) better and more efficiently and to~     gain more insights on its relation to Alzheimer's disease (AD), a comprehensive~     understanding is needed for its progression in the early or preclinical phase using various~     biomarkers. DS is a significant risk factor for the early development of AD, with plaques~     and tangles typically developing by age 35. A better understanding is needed of early~     markers of the disease in DS patients. Additionally the DS population represents a unique~     group - due to this elevated risk for AD - to examine biomarkers that may translate in~     general outside of the DS population to individuals at risk for developing late onset AD. In~     this proposal, the researchers will assess the longitudinal changes of various biomarkers in~     a cohort of individuals similar in design to the cross-sectional sectional study in the~     preliminary data.~   "
22712|NCT02759874|"~     The Institute of Health Economics is conducting a study to determine how a breathalyzer~     linked to a cloud based alcohol monitoring system changes alcohol consumption during~     pregnancy in women with alcohol dependency issues.~      IHE posits that the ability to self-monitor blood alcohol concentration and the ability to~     share sobriety via email or text with loved ones and counselors may reduce alcohol~     consumption and thus reduce the possibility of delivering a child with FASD.~      The study will provide useful evidence for tailoring future optimal maternal and child~     healthcare for women, with the potential of decreasing healthcare utilization by prevention~     of FASD. Breathalyzer device usage plus secure document sobriety should improve patient~     monitoring convenience and demonstrate reductions in alcohol use outside of traditional~     office visits and patient self-reports.~   "
22713|NCT02759861|"~     To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with~     Genotype 1 HCV infection~   "
22714|NCT02759848|"~     Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD)~     has not been well known. This study was designed to investigate the effects of history of TB~     on the long-term course of COPD.~   "
22715|NCT02759835|"~     Background:~      Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein~     called EGFR. This particular cancer can be treated with certain drugs such as Erlotinib~     (Tarceva), Gefitinib (Iressa) and Osimertinib (Tagrisso). But many tumors become resistant~     to these drugs because of a second mutation. Researchers want to test if adding local~     ablative therapy (LAT) extends the benefits of the drug, Osimertinib. LAT can include~     techniques such as surgery, radiofrequency ablation, cryotherapy or radiation therapy.~      Objective:~      To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people~     whose NSCLC has progressed after initial treatment with osimertinib.~      Eligibility:~      Adults ages 18 and older with certain types of NSCLC. Participants will be divided into~     various groups as described below.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Tumor scans~      Eye exam~      Review of tumor sample.~      Participants will take the study drug by mouth once a day. They will continue until they can~     no longer tolerate it or their disease worsens. They will keep a dosage diary.~      All participants will start each 21-day course with physical exam; blood, urine, and saliva~     tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3~     months.~      Groups 1 and 2 will:~      Start osimertinib right away.~      Have LAT if their disease gets worse and is suitable for LAT. If LAT cannot be performed or~     LAT consists of a procedure other than surgery, a tumor biopsy will be performed.~      Re-start osimertinib after LAT, or other treatments if not suitable for LAT.~      Group 3 will:~      Have LAT.~      If LAT consists of a procedure other than surgery, a tumor biopsy will be performed.~      Start osimertinib after LAT.~      After participants stop taking the drugs, they will have a final visit. This will include:~      Medical history~      Physical exam~      Heart and blood tests~      Participants will be called every year for follow-up.~   "
22716|NCT02759822|"~     This is a prospective observational cohort study of haploidentical transplantation with~     post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning~     for acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic~     leukemia (ALL).~   "
22717|NCT02759809|"~     In Canada, the leading cause of long-term disability in children is being born at very low~     birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant~     care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement~     of donor milk or preterm formula as not enough mother's milk is available. As the ideal~     supplement for prolonged feeding and its long-term effects is currently unknown, this study~     is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm~     formula and/or mother's milk. Areas of development to be assessed include: cognition,~     language, motor skills, brain structure/function, and body composition. A DNA biorepository~     will also be created.~   "
22718|NCT02759796|"~     It is a single-center, prospective, randomized and controlled study focused in microsurgical~     autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography~     for the study of the vascularization of DIEP flaps. The aim of the study is to determine~     whether there are differences in complications and aesthetic results when ICG is used to~     discard the poorly vascularized areas of the flap. The study includes adult women undergoing~     unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There~     are two groups. In group 1, the investigators use the usual clinical criteria to discard the~     poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape~     the flap.~   "
22719|NCT02759783|"~     Metastatic spread of cancer from its primary site to distant organs is the commonest cause~     of death from cancer. The term oligometastases describes an intermediate metastatic state,~     in which cancer exists as a limited number of metastases at first, before cells acquire the~     ability to metastasise more widely. For the large majority of solid cancers, once metastatic~     disease has been diagnosed the chances of cure are small. There are several situations where~     this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for~     oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment~     is justified. SBRT is targeted radiotherapy which destroys cancer cells in the area of the~     body it is aimed at however low dose radiation may be received by surrounding tissue.~      It is difficult to quantify incidence of patients with multiple primary cancers developing~     at intervals that are representative of oligometastatic stage IV disease, (defined for the~     purposes of this trial as ≤ 3 metastatic sites). However an increase in the use of~     surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis~     of patients with asymptomatic oligometastatic relapse becoming a more common clinical~     occurrence. The CORE study is a randomized controlled trial that will be conducted in~     patients with cancer in one of three primary sites where oligometastatic disease relapse is~     a common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The~     study will evaluate the use of SBRT in this patient population.~      Eligible patients who consent to participate in this clinical trial will be randomized to~     receive standard care or standard care plus SBRT we hope to recruit approximately 206~     patients to the study and the primary outcome measure is progression free survival.~   "
22720|NCT02759770|"~     Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis~     of patients; the mortality is up to 40%. Although experience many years of research and~     exploration, the effective methods for the treatment of acute respiratory distress syndrome~     is still relatively limited at present, including lung protective mechanical ventilation~     respiratory support, fluid management, glucocorticoid and other integrated organ function~     maintenance measures. It is currently the research of acute respiratory distress syndrome~     aims at the early discovery and takes effective measures to prevent its occurrence, hoping~     to improve the prognosis of patients. According to risk factors is established through the~     analysis of lung injury score early warning system, the early identification of acute~     respiratory distress syndrome patients at high risk, before the occurrence of acute~     respiratory distress syndrome take corresponding preventive measures can effectively reduce~     the incidence rate and mortality. So far, domestic and foreign research on the establishment~     of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery~     has significant characteristics, type of operation, location, operation, intraoperative~     blood transfusion and oxygenation, postoperative factors, are likely to be the factors of~     acute respiratory distress syndrome. As far as investigators know, so far there are few~     specialized for acute respiratory distress syndrome predicting lung injury after cardiac~     surgery. This study will be completed after the implementation of individualized dynamic~     lung injury score evaluation of cardiac surgery patients, identification of high-risk acute~     respiratory distress syndrome patients, to assist clinicians in early decision, take~     preventive measures. This study will improve the prognosis of acute respiratory distress~     syndrome patients after cardiac surgery; it is of great significance to improve the level of~     intensive care after cardiac surgery.~   "
22721|NCT02759757|"~     Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal~     of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.~      Study design: Three-arm, randomized controlled trial with a blinded assessor.~      Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)~      Patients: Sixty-three patients with chronic nonspecific low back pain.~      Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as~     described by the manufacturer's manual. The patients assigned to the placebo group will~     receive a Micropore tape and the control group will not receive any intervention. All groups~     will be assessed before and 30 minutes after intervention~      Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.~      Limitations: Therapists will not be blinded.~   "
22722|NCT02759744|"~     Background:~      Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less~     aggressive disease are limited. Researchers want to test a device that destroys cancerous~     tissue with laser energy. They want to see if using it with ultrasound is more comfortable~     than using it with magnetic resonance imaging (MRI).~      Objectives:~      To test a cooled laser applicator system to treat prostate cancer lesions. To see if~     ultrasound imaging is a practical and feasible treatment with laser ablation for focal~     prostate cancer treatment.~      Eligibility:~      Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.~      Design:~      Participants will be screened with standard cancer care tests. These can include physical~     exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures.~     Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the~     prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the~     rectum.~      Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be~     put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.~      The cooling catheter will be removed. A different catheter will be put in the urethra to~     keep the bladder emptied.~      The next day, participants will have a physical exam and a PSA blood test.~      Participants will have 6 follow-up visits over 3 years. At each visit, they will have a~     physical exam and lab tests. At some visits, they will also have an MRI or other scans and a~     prostate biopsy.~   "
22740|NCT02759510|"~     Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure~     in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral~     vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result~     in cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor~     agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure~     the same asphenylephrine, meanwhile produce positive inotropic effect including increasing~     heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid~     the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and~     phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.~   "
22723|NCT02759731|"~     Background:~      Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem~     cell transplant using donor cells. It is often fatal. It is usually treated with high doses~     of steroids. But that helps only about half the people in the long term. Researchers want to~     see if a drug called baricitinib can help people with cGVHD that has not responded to~     therapy. The drug inhibits the proteins involved in communication in the immune system.~     These proteins may play a role in cGVHD and other inflammatory diseases.~      Objectives:~      To test the safety and effectiveness of baricitinib in people with cGVHD that has not~     responded to therapy.~      Eligibility:~      Adults 18 and older with cGVHD that has not responded to therapy.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will have lung and heart tests and chest scans.~      Baseline visit: Participants will have:~      Medical history~      Physical exam~      Blood tests~      Tests for infectious diseases~      Skin, eye, and teeth evaluations~      Rehabilitation and occupational medicine evaluations~      Photos of any lesions~      Gynecology evaluation (females)~      The study will occur in 28-day cycles. Participants will take the study drug by mouth every~     day for 3 cycles. Some will take it for 3 or 6 more cycles.~      Participants will have a few visits during each cycle. They will repeat some previous tests.~     They may also have scans and questionnaires.~      Participants will have a visit when they stop taking the drug and another 3 months later.~     They will repeat a few study tests. They will have follow-up calls for 2 years.~   "
22724|NCT02759718|"~     Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by~     chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine~     cells of the stomach and pancreas, and it is the precursor to several functional peptides~     including vasostatin and pancreastatin.~      Importantly, CgA can be measured in the serum or plasma or detected within the secretory~     vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA~     levels also provide information regarding tumor burden and response to treatment. It has a~     sensitivity and specificity between 27% and 81%.~      Some studies have noted an association between CgA concentrations and tumor location or~     degree of differentiation. It has also been proposed that plasma CgA levels are more~     frequently elevated in well-differentiated tumors compared with poorly differentiated tumors~     of the midgut. Some other clinical series have provided evidence of an association between~     plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and~     high baseline levels of CgA are suggestive of a poor prognosis.~      However, there exist still controversies the effectiveness of serum CgA levels on diagnostic~     relevance, treatment response after surgical resection or sandostatin analog,~     clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).~      To date, moreover, a precise association between CgA levels and survival has not been~     clearly demonstrated, although a number of studies suggest that this relationship may exist.~     There, especially, is no relevant data on value of serum CgA level for clinical usefulness~     in Korean population.~   "
22725|NCT02759705|"~     This analytical descriptive study aims to describe the fertility and sexuality male adult~     subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk~     factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual~     self-esteem and a semen analysis will be realized at first consultation, semen analysis~     results wil be explained at second consultation. It is assumed that fertility and sexuality~     exstrophic men are impaired.~   "
22726|NCT02759692|"~     Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical~     performance of two FDA-approved contact lens.~   "
22727|NCT02759679|"~     The study aims to optimize and define a reproducible and non-invasive method for canine~     assisted lung cancer detection, using human breath samples from patients and controls for~     training and testing purposes.~   "
22728|NCT02759666|"~     This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to~     evaluate the safety and tolerability of SHR3162 in participants with advanced solid tumors.~   "
22729|NCT02759653|"~     BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this~     category hides an additional number of strokes caused by artery-to-artery embolisms due to~     unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated~     with a high risk of recurrent ischemic events and multiple cerebral infarctions.~      Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause~     in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery.~     Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography~     and estimation of the overall atherosclerotic plaque burden aids future risk prediction.~     Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic~     alterations and certain plaque characteristics are important for the evaluation of plaque~     vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a~     non-invasive bedside examination eligible for detection of microemboli in the human cerebral~     circulation.~      HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately~     assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS),~     and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque~     improve the differentiation of stroke etiology and quantification of plaque vulnerability,~     and aid the prediction of future risk for cerebrovascular events in the individual patient.~      AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected~     patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the~     relationship between MES and recurrent stroke or Transient ischemic attack (TIA).~      Categorization of atherosclerotic carotid artery disease by use of routine and advanced~     neurosonographic techniques combined with anamnestic and clinical data.~      Development of a visualization solution tailored for 3D visualization of carotid arteries~     and semi-automatic plaque segmentation.~   "
22730|NCT02759640|"~     This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects~     with solid tumors. HS-10241 will be administered orally once daily.~   "
22741|NCT02759497|"~     One of the most common and serious complications in decompensated cirrhotic patients (DCPs)~     is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial~     peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections,~     pneumonia and cellulitis.~      Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly~     produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and~     macrophages can also produce these proteins. The induction of SAA and CRP synthesis is~     triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell~     types, but mainly from macrophages and monocytes at inflammatory sites~   "
22843|NCT02758171|"~     The primary objective of this trial is to investigate the bioequivalence of one fix dose~     combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination~     of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single~     dose under fasted conditions.~   "
22731|NCT02759627|"~     Stroke is one of the major cause of morbidity and mortality and the leading cause of~     disability in adults all around the world. Stroke survivors can suffer several neurological~     impairments and deficits which have an important impact on patient's quality of life and~     which increase the costs for health and social services. After stroke, impairments in ADLs~     and functional status, deterioration in health related quality of life can be seen.~      Although most of the stroke survivors experience some level of neurological recovery, nearly~     50%-60% of stroke patients still experience some degree of motor impairment, and~     approximately 50% are at least partly dependent in activities-of-daily-living (ADL). Gait~     recovery, performing activities of daily living and regaining independence in ADLs are the~     main focus of stroke rehabilitation programs.~      Robotic technologies are becoming more promising techniques for the locomotor training in~     stroke patients. Achieving a functional walking level is one of the target of robotic gait~     training and it has been shown that Robotic-Assisted Gait Training (RAGT) improves walking~     function in stroke patients. Having a functional gait level may help the stroke patients to~     regain independence in ADLs and improve quality of life.~      The purpose of the present study was to investigate the effects of RAGT on functional~     status, ADLs and health related quality of life.~   "
22732|NCT02759614|"~     This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be~     randomly assigned to treatment group (1:1) through a dynamic randomization process with use~     of the following stratification factors: sex (female/male), disease stage (stage IIIb vs.~     stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).~   "
22733|NCT02759601|"~     This study is being carried out to assess the best dose of a new drug, called tefinostat, in~     treating liver cancer.~      Tefinostat is a new drug that blocks enzymes called histone deacetylases (pronounced~     dee-as-et-isle-azes). Cells need these enzymes to grow and divide. Blocking them may stop~     cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or~     'HDAC inhibitors'.~      Tefinostat has never been given to patients with liver cancer before so we don't know which~     dose is best at treating liver cancer. To find this out we will be testing one dose and if~     that is safe we will then test a higher dose and so on. Eventually we will find the best~     dose; we do not know when this will be. When we find the best dose we will treat another 39~     patients with this dose.~      The aim of this study is to find the best dose of tefinostat without causing side effects.~     We will be looking closely at any side effects you might experience from this treatment.~   "
22734|NCT02759588|"~     The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well~     tolerated with anti-tumor activity in patients diagnosed with recurrent ovarian cancer and~     peritoneal carcinomatosis.~   "
22735|NCT02759575|"~     The purpose of this research study is to test the safety and the benefit of adding~     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of~     care treatment for cancer. The standard of care treatment will include chemotherapy and~     radiation for 7 weeks.~   "
22736|NCT02759562|"~     This study will evaluate the effect of GS-5745 on pre-bronchodilator FEV1 in adults with~     cystic fibrosis (CF) after 8 weeks of treatment.~      There will be 2 parts to this study. In Part 1, GS-5745 600 mg or placebo will be~     administered for 8 weeks. In Part 2, GS-5745 300 mg, 150 mg, or placebo will be administered~     for 8 weeks. Part 2 will be initiated after completion of Part 1.~   "
22737|NCT02759549|"~     The purpose of this study is to determine if an avatar-based depression self-management~     intervention (eSMART-MH) once a week for the duration of the participant's radiation~     treatment will significantly reduce depressive symptoms. Investigators also seek to explore~     how women with breast cancer describe their mood using prompted and unprompted speech~     through electronic social media and interviews.~      Participants will be randomized into the eSMART-MH group or the theater testing (attention~     control) group. In addition to the assigned interventions, participants will be asked to~     complete questionnaires and interviews with the study staff.~   "
22738|NCT02759536|"~     Boron Neutron Capture Therapy (BNCT) has been used in the treatment of several types of~     malignant tumors, including malignant melanoma, high-grade gliomas, and advanced head and~     neck cancers. Theoretically, it represents a more precise radiotherapy in that it could~     spare normal cells while destroy malignant ones. However, its value is largely restricted by~     the fact that it could only be performed in the nuclear research reactors, the only neutron~     source at the time. In 2010, the world's first in-hospital neutron irradiator (IHNI) had~     been constructed in Beijing, China, and this study aims to evaluate whether IHNI has the~     potential to serve as an effective in-hospital neutron source for BNCT.~   "
22739|NCT02759523|"~     Increased portion sizes of foods high in energy density (calories per gram of food) have~     been implicated in the obesity epidemic. Numerous studies show that children and adults eat~     more from larger portions of food than they do from smaller portions, a response known as~     the portion size effect. Despite the robust and consistent nature of these findings, the~     mechanisms underlying the portion size effect are not known. The long-term goal of this~     research is to identify the neural mechanisms involved in the portion size effect so that~     this information can be used to develop effective weight-management strategies. Differences~     in neural response to food cues, as demonstrated by functional magnetic resonance imaging~     (fMRI), can help clarify the factors that determine susceptibility to large portions. The~     goal of this study is to identify brain regions activated in response to portion size and~     energy density and relate these neural responses to laboratory eating behaviors in children.~      The investigators hypothesize that high relative to low energy density food images will be~     associated with increased activation in regions of the brain involved in reward- and~     sensory- processing and that large relative to small portion size food images will be~     associated with increased activation in regions of the brain involved in cognitive control.~     In addition, the investigators hypothesize that these brain responses will influence the~     relationship between portion size served and energy intake at laboratory meals.~   "
22869|NCT02757833|"~     Female participants with an episode of late-life depression (LLD) and age-matched control~     participants with no history of mental disorder will attend a one hour Magnetic Resonance~     Imaging (MRI). A 3 Tesla MRI scanner will be used to measure levels of glutathione (GSH) in~     the brain via magnetic resonance spectroscopy (1H MRS).~   "
22870|NCT02757820|"~     The aim of this randomized trial will be to evaluate the clinical performance of the I-gel,~     air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery~     under general anesthesia.~   "
22742|NCT02759484|"~     The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension)~     is a randomized controlled trial comparing two educational approaches to improve glucose and~     blood pressure control in African American and Latino adults with type 2 diabetes. The study~     is being designed and implemented using a Community Based Participatory Research approach to~     optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts~     a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American~     Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based~     Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general~     self-management education. The study seeks to determine if Community Health Workers working~     as part of the primary care clinical team can reduce health disparities and improve outcomes~     among patients with type 2 diabetes.~   "
22743|NCT02759471|"~     This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing~     study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens~     (control) following a refit with comfilcon A asphere lens (test). After the dispensing~     visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.~      Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison~     lenses.~   "
22744|NCT02759458|"~     The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the~     Smith & Nephew Healicoil anchor. This anchor utilizes a small open-construct design to~     promote bone-in growth and potentially allow for the release of bone marrow factors into the~     repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator~     cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth.~      Thus, this study consists of three separate aims in order to clinically and biochemically~     investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff~     repair. One, evaluate the bone in growth of the anchor compared to a standard poly-ether~     ether ketone (PEEK) anchor. Two, analyze the marrow elements that are released into the~     repair site through the open construct. Three, compare the functional outcomes of patients~     with rotator cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK~     anchor.~   "
22745|NCT02759445|"~     Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac~     dysfunction. In general, patients consuming alcohol more than five years are at risk for the~     development of dilated cardiomyopathy. As only few data about immediate changes in left~     ventricular function after acute excessive alcohol ingestion are available, this study~     sought to close this gap.~      Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12~     hours after alcohol excess and after 4 weeks of complete alcohol abstinence.~     Echocardiography will performed at baseline and at follow-up regarding conventional~     parameter [as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A)~     Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation~     time (IVRT)] and myocardial deformation data [as layer specific global circumferential (endo~     GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain].~   "
22746|NCT02759432|"~     Low-volume high-intensity interval exercise training may improve aspects of health and~     fitness in young people, but the effect of this type of exercise on quality of life has yet~     to be assessed. The investigators aim to examine the effect of a 4-week school-based~     low-volume high-intensity interval training programme (called the Fun Fast Interval Training~     [FFIT] activity project) on physical fitness and quality of life in adolescent school~     pupils. Approximately 145 English adolescents aged 11-12 years will be approached and~     invited to take part in the study. Participants will be healthy female volunteers, recruited~     from one school in Northeast England. Using a non-randomised design, one school year group~     will be assigned to take part in the intervention, and a second year group assigned to the~     control condition.Those in the intervention group will complete a 4-week school-based~     high-intensity interval exercise training programme. The intervention will take place twice~     per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running,~     soccer and basketball drills), each interspersed with 90-s rest. Participants will be~     encouraged to work maximally during the 45-s repetitions. Control participants will be~     instructed not to change their lifestyle, dietary or physical activity habits during the~     intervention period, and maintain their normal school physical education routine. Study~     outcomes will be 20 m shuttle run test performance, health-related quality of life, standing~     broad jump performance, hand dynamometer performance, waist circumference and 10 m and 20 m~     sprint performance.~   "
22747|NCT02759419|"~     Provide riociguat therapy to patients with Pulmonary Arterial Hypertension (PAH) originating~     from the Bayer-sponsored trials 12935 PATENT-2 or 16719 RESPITE who are currently or~     recently treated in these trials until lack of patient benefit, or commercial availability~     and reimbursement.~   "
22748|NCT02759406|"~     This is a six (6) month, randomized, un-blinded, study to assess the safety and performance~     of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent~     System.~   "
22749|NCT02759393|"~     The purpose of this study is to investigate whether dexlansoprazole can be as effective as~     double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles~     grades A & B.~   "
22750|NCT02759380|"~     The purpose of this study is to evaluate if a diet with a high content of phytoestrogens can~     slow down the prostate tumor proliferation. Phytoestrogens are found in food items such as~     soy, rye, and seeds.~      Two hundred thirty men with prostate cancer will be included in the study and followed until~     surgery (at least 6 weeks). Half of the study participants will receive general information~     about healthy food choices and a package of foods with high content of phytoestrogens to add~     to their food. The other half will get the same information but not receive the~     food-package.~   "
22751|NCT02759367|"~     This study evaluates the safety of increasing dietary potassium intake in a hypertensive~     population that may be at risk for hyperkalemia.~   "
22752|NCT02759354|"~     To describe long-term persistence of Hepatitis B and pertussis antibody responses in healthy~     4- to 5 Year old children previously vaccinated with VAXELIS or INFANRIX hexa~   "
22871|NCT02757807|"~     The aim of this study is to determine if patients with ED taking PDE5 inhibitors (e.g.~     Viagra, CIalis, Levitra, Stendra) and experiencing performance anxiety will benefit using a~     user-friendly stress reducing phone app, Serenita. The study is internet based with no~     office visits.~   "
22753|NCT02759341|"~     The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute~     and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris~     without alterations of large coronary vessels. The causes and the most appropriate and best~     treatment for these diseases have not been yet clarified, but there are indications, that~     mental and psychosocial aspects may also contribute to these two diseases. So far, there is~     no study, which has comprehensively evaluated the interactions between mind and heart in~     these two conditions.~      The purpose of this study is to search for possible differences in mental activity, response~     to stressful events and function of specific areas of the brain deeply involved in relation~     between mind and heart.~      45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC~     (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6~     months ago). All participants will undergo a clinical interview and several questionnaires~     that assess various mental functions, the stress response and the quality of life. In~     addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging~     without contrast medium that helps to assess function of specific areas of the brain.~   "
22754|NCT02759328|"~     Commercial interactive game consoles including the Nintendo Wii™ and the Sony Playstation~     Eyetoy™ have been used in stroke rehabilitation with variable success and seemed to be safe,~     feasible and effective treatment options. The more recently released Xbox Kinect™ game~     console has superiorities to the others such as not requiring any special controller and~     having a more sensitive sensor which provides more accurate motion-capturing. However, there~     is limited evidence on clinical utility of the Xbox Kinect™ in stroke rehabilitation.~     Currently it has been designed for physically and mentally healthy people just like previous~     consoles. Therefore, the safety and feasibility of the system should be evaluated in first~     place before using it as an alternative or adjunctive training method in stroke patients. To~     the best of our knowledge, no studies have evaluated the clinical feasibility of the Xbox~     Kinect™ in stroke rehabilitation. The aim of this pilot study was to evaluate the~     feasibility and safety of the Xbox Kinect™ training of upper extremity in subacute stroke~     rehabilitation. The secondary aim was to evaluate its efficacy on upper extremity motor and~     functional recovery.~   "
22755|NCT02759315|"~     The study is a single-center, multiple-arm investigation of co-administration of MK-3682 450~     mg and Ruzasvir (MK-8408) 60 mg in participants with chronic Hepatitis C Virus (HCV)~     Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen on~     Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after~     ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants~     and non-cirrhotic participants.~   "
22756|NCT02759302|"~     POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome.~     Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder~     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and~     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into~     more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very~     few patients with the LGMD2N phenotype has been reported. In this study, the investigators~     examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle~     involvement using MRI.~   "
22757|NCT02759289|"~     Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients~     with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined~     as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or~     without diabetes medications. Group C will include 50 participants without T2D or known~     cardiovascular disease to serve as control comparisons.~   "
22758|NCT02759276|"~     Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory~     biomarkers have been used to study endothelial function in patients with resistant~     hypertension, stages 1 and 2 hypertension and normotensive. This was a cross-sectional~     study.~   "
22759|NCT02759263|"~     Executive dysfunction can profoundly impact all dimensions of a child's development.~     Impairments in executive function are a central component of the neurodevelopmental~     phenotype associated with CHD, and manifest as behavioral dysregulation and problems with~     attention, working memory, and organization/planning abilities. Identifying effective~     treatment strategies is vital for providing optimal care for these patients. The Cogmed~     executive function intervention, an evidence-based computerized neurocognitive program,~     improves outcomes in several pediatric populations. The investigators propose to conduct a~     pilot study to evaluate its efficacy in reducing morbidities in patients with CHD. This is a~     single center, single blinded 2-arm randomized controlled trial to test the immediate~     post-treatment and 3-month follow-up efficacy of Cogmed intervention versus standard of care~     in adolescents with CHD.~   "
22760|NCT02759250|"~     To characterize the safety profile of ARGX-110 administered as mono- or combination therapy~     to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).~   "
22761|NCT02759237|"~     The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been~     demonstrated to be safe and effective for high through extreme risk patients with~     symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical~     bioprosthetic valve failure. Per DCGI systematic post marketing surveillance requirement,~     the purpose of this PMS plan is to provide local post marketing surveillance data regarding~     the safety of Medtronic CoreValve System Family~   "
22762|NCT02759224|"~     An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics~     of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual~     Tablets in Healthy Adult Volunteers~   "
22763|NCT02759211|"~     There have been no published studies to date on the effects of backwards walking in persons~     with MS. Thus it is important that the investigators explore different methods for treatment~     to help improve balance and gait and prevent injury in persons with MS with gait~     disturbances and balance impairments.The overall goal of this research is to collect pilot~     data on the effectiveness of backwards walking as a therapy for improving spatiotemporal,~     clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward~     walking.~   "
22764|NCT02759198|"~     The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in~     patients with knee osteoarthritis.~   "
22765|NCT02759185|"~     Posttraumatic stress disorder (PTSD) is a debilitating disorder experienced by a subset of~     individuals following life-threatening trauma, such as sexual and physical assault, natural~     disasters, and military combat. Despite there being a number of treatments for PTSD, there~     is a need to help people who have treatment-resistant PTSD and do not benefit from these~     treatments as many individuals continue to experience marked PTSD symptoms following~     treatment. In response to overwhelming demand, several U.S. states have passed laws allowing~     the medical use of cannabis (marijuana) by individuals with PTSD. Unfortunately, there has~     been very little scientific evidence on suitability of cannabis as an alternative therapy~     for PTSD. The purpose of this study is to find out if cannabis can reduce PTSD symptoms in~     76 military veterans with treatment-resistant PTSD. Four different types of smoked cannabis~     will be evaluated using a triple-blind cross-over placebo controlled design. Study~     participation will last 8.5 months. Participants will select a community observer, a friend~     or relative who can be contacted by the researchers, who will report on the participant's~     health and well-being throughout the study. After screening and meeting study requirements,~     participants will be randomly assigned to receive one of four types of cannabis that vary~     based on THC and CBD content. During the study, each participant will smoke two of the four~     types of cannabis, up to 1.8 grams per day, for a 3-week period. Participants can smoke~     their daily 1.8g cannabis at any time, using as much as they need. After each 3-week~     cannabis use period, they will stop smoking marijuana/cannabis for two weeks where no~     cannabis use will be allowed. Study findings will help researchers better understand the~     risks and benefits associated with cannabis use among veterans with PTSD, information that~     can be used to aid in shared decision-making among people with PTSD and their doctors or~     therapists.~   "
22766|NCT02759172|"~     The four year SPIRIT Trial, or Suicide Prevention Intervention for at-Risk Individuals in~     Transition, will recruit 800 pretrial jail detainees at risk for suicide. Each participant~     will be randomly assigned to today's standard care or to Safety Planning Intervention (SPI)~     method and then followed for one year after release. Outcomes include suicide events,~     suicide attempts and ideation, psychiatric symptoms, functioning, treatment utilization,~     problem-solving, belongingness, and cost-effectiveness.~   "
22767|NCT02759159|"~     Alzheimer's disease (AD) is one of the major brain diseases which received more attention in~     recent years. The disconnection syndrome is the main pathophysiological mechanism leading to~     cognitive decline in AD patients. Both animal experiment and clinical observation have~     demonstrated that acupuncture can generate treatment effect on AD patients by moderating the~     neural pathway directly. However, the underlying mechanism remains unclear. By using resting~     state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and~     neurology sciences, investigators will explore the multi-modality data analysis; compare~     brain connectivity and network parameters changes between pre- and post- acupuncture~     treatment; analyze the correlation between fMRI changes and neuropsychology test. The~     present study aims to elucidate the neural mechanism of acupuncture therapy on early AD,~     provide theoretical evidence from the perspective of functional connectivity.~   "
22768|NCT02759146|"~     In order to optimize symptom management, there must be a shift from fixed interventions one~     size fits all to adaptive interventions tailored to individual patients. Our multistaged~     interventions use the sequential multiple assignment randomized trial (SMART) design. This~     design will operationalize the decision rules for switching from one intervention to another~     for individual patients. Our team's work to date with breast and lung cancer patients has~     shown efficacy for two home-based symptom management interventions, reflexology and~     meditative practices, delivered by or with friend or family caregivers. The sustainability~     of use of these two evidence based therapies and improvements in symptom outcomes will be~     tested during weeks 5-8 and at the week 12 follow up of 331 patients based on power~     analysis, against a control group. By sequencing two evidence based interventions, the~     proposed research will impact research and practice by determining how to maximize the~     benefit of symptom management during cancer treatment.~   "
22769|NCT02759133|"~     This is a monocentric, non-inferiority, randomized cohort study with an open 1:1 ratio~     comparing the impact of iodine seed tumor localization (arm B) vs. standard localization~     using a metal guide (arm A) on the quality of the surgical resection margins in parallel~     groups with an interim analysis in patients with breast cancer.~      Randomization will be performed using histologic status stratification: in situ ductal~     /invasive lobular +/- an in situ component / invasive ductal +/- an in situ component.~   "
22770|NCT02759120|"~     The purpose of this study is to compare the effect of standard care, versus standard of care~     plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients~     diagnosed with idiopathic pulmonary fibrosis (IPF).~   "
22771|NCT02759107|"~     The main purposes of this study are to determine:~        -  The safety of LY3298176 and any side effects that might be associated with it.~        -  How much LY3298176 gets into the bloodstream and how long it takes the body to get rid~          of it.~        -  How LY3298176 affects the levels of blood sugar.~      This study includes 3 parts (A, B and C). Part A involves a single dose of LY3298176 taken~     as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in~     duration, including screening. Parts B and C involve 4 doses of LY3298176 taken once weekly~     (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in~     duration, including screening. Each participant will enroll in only one part.~      This study is for research purposes only, and is not intended to treat any medical~     condition.~   "
22772|NCT02759094|"~     Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the~     safety and effectiveness of RefluxStop for the treatment of GERD.~      The used medical device RefluxStop is an implantable single use sterile device to ensure~     maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or~     eliminate GERD.~   "
22773|NCT02759081|"~     This prospective, randomize, controlled trial will compared cap-assisted water exchange with~     water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis~     that that cap-assisted water exchange is more efficient and causes a shorter insertion time.~   "
22774|NCT02759068|"~     Preferred music improves cognitive function in patients with disorders of consciousness~     (DOC). However, it is still unknown whether it is a general effect of music (because of its~     acoustic features) or an autobiographical effect (because of its emotional and meaningful~     contents).~      The aim of the present study was to investigate the effect of sensory modality (auditory~     versus olfactory) and preference (preferred versus neutral) of the testing context on the~     performance of four items from the coma recovery scale-revised~   "
22896|NCT02757482|"~     The purpose of this study is to examine the effects of patient training about the safety of~     warfarin therapy on related knowledge levels and on International Normalized Ratio (INR)~     control.~   "
22775|NCT02759055|"~     Nearly one in three adults has prediabetes, a condition that substantially increases the~     risk of heart attacks and stroke. The increased cardiovascular risk associated with~     prediabetes can be effectively managed by lifestyle changes or medication therapy, but~     recent data shows few prediabetes patients are treated effectively. In this project, we will~     adapt, implement, and evaluate a proven electronic health record-linked, web-based clinical~     decision support system to identify patients with prediabetes and provide prioritized~     treatment recommendations to patients and providers in a rural health system. The results of~     the project will provide a template for implementation of more efficient and effective rural~     healthcare and have the potential to substantially and improve cardiovascular quality of~     care and clinical outcomes of millions of rural Americans with prediabetes.~   "
22776|NCT02759042|"~     The primary objective is to provide continued access to PRO 140 to a subject who has~     completed participation in PRO140_CD02.~   "
22777|NCT02759029|"~     Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy~     are declining, and an alternative strategy is needed urgently. The investigators sought to~     compare the efficacy of pretreatment antimicrobial susceptibility-guided vs.~     clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a~     region with high rates of multiple drug resistance.~   "
22778|NCT02759016|"~     Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic~     Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line~     of systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the~     trial are to determine the recommended Phase 2 dose of BI 836826, to investigate the number~     of patients with a complete response and to document the safety and tolerability of BI~     836826 when given in combination with ibrutinib~   "
22779|NCT02759003|"~     In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation~     (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV~     initiated in an outpatient setting can be as effective as regards patients' adherence. The~     investigators also evaluated factors predicting NIV adherence and disease progression.~   "
22780|NCT02758990|"~     The purpose of this study is to study interactions between genes, lifestyle environmental~     factors like foods, nutritional supplements and non-invasive medical devices and health~     factors that can be measured without specialized medical equipment in order to develop~     lifestyle recommendations tailored to individual genetics for a host of common chronic~     health conditions.~   "
22781|NCT02758977|"~     Surgical resection has offered the best option for prolonged survival in patients with~     colorectal liver metastases. Limiting factor for major liver resections is the size of the~     future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume~     is considered to be sufficient to maintain adequate liver function after resection. In an~     attempt to further increase resectability criteria for patients with too small FLR~     surgical and interventional maneuvers such as portal vein embolization and portal vein~     ligation in two-stage hepatectomies have been implemented, but they need an interval of 4-8~     weeks to achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal~     hypertrophy a new surgical two-step technique, ALPPS, was introduced for oncological~     patients requiring extended hepatic resection with limited functional reserve. Both~     procedures can be performed with acceptable morbidity and mortality.~      The investigators conclude that it is time to perform a randomized study comparing the two~     surgical approaches in regard to oncological outcome.~   "
22782|NCT02758964|"~     EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of~     cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months~     after TAVR.~   "
22783|NCT02758951|"~     The purpose of this study is to determine whether cytoreductive surgery and HIPEC, combined~     with preoperative chemotherapy with targeted therapy and postoperative chemotherapy, results~     in improved overall survival compared to cytoreductive surgery and HIPEC alone in patients~     with peritoneal metastases of colorectal cancer.~      A survival increase of 15% is expected in the systemic therapy group. Furthermore,~     neoadjuvant systemic therapy may allow for better patient selection.~   "
22784|NCT02758938|"~     The goal of this study is to test the usability of updated biofeedback game software~     developed to help train the muscles involved in lower urinary tract dysfunction (LUTD)~     through electromyography (EMG) controlled video games.~      A Windows-DOS based biofeedback game system is currently used at the investigator's~     institution to help treat LUTD in pediatric patients. This system, however, is outdated and~     needs to be replaced with updated hardware and software. A new updated system was recently~     created by University of Wisconsin-Madison (UW) Biomedical Engineering students. This system~     utilizes a FDA approved EMG device (SRS Medical Aware™ EMG Dual Muscle Monitor) paired with~     biofeedback game software that was developed by the students. The investigators wish to test~     the usability of the new software to identify areas that need improvement to make the~     software more user-friendly.~      This study will evaluate the end users' (i.e., physician, biofeedback nurses, patients)~     perception of the updated software. In determining usability, we hope to 1) decrease risk of~     end user error; 2) make the software intuitive (easier to use); 3) decrease reliance on the~     user manual; 4) decrease need for training; and 5) increase understanding of software~     operation. This will be an ongoing study in which we continuously monitor the usability of~     the software as it is updated based on end-user feedback. The investigators plan to do all~     usability testing under the same IRB protocol. If further testing involves items not~     discussed here, a new change will be made to the IRB application.~   "
22795|NCT02758795|"~     The aim is to evaluate the effect of ingestion of a modified bovine milk protein on~     circulating markers of inflammation in healthy men and women aged 50-70y.The focus is~     healthy ageing, i.e. delaying the deterioration in health status in older adults. Loss of~     lean tissue mass, termed sarcopenia is a consequence of aging per se, modified by nutrition~     and lifestyle behaviour. Advancing the prospect of 'successful aging' a 6-month period of~     protein-based nutritional support has shown preservation/accrual of lean tissue. Chronic~     low-grade inflammation is common in ageing and is a compounding factor leading to 'anabolic~     blunting', i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue~     mass in response to protein feeding. Using a simulated human gastrointestinal digestion~     model we have recently shown proteins to have an anti-inflammatory bioactivity in vitro.~     This study investigates whether the anti-inflammatory response is retained, post-digestion~     in vivo.~   "
22785|NCT02758925|"~     Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory~     or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy~     is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no~     ASCT is possible due to progressive disease. For these patients or ineligible to~     transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine~     regimen with an overall response rate (ORR) about 50%.~      Bendamustine in combination with rituximab, used as a single agent in the setting of R/R~     DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.~      Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell~     lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine~     with Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were~     previously untreated, refractory or relapsed was evaluated.~      The efficacy and safety of the R-BAC association will be evaluated in this phase II trial~     enrolling 78 patients with relapsed or refractory DLBCL.~   "
22786|NCT02758912|"~     The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic~     parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.~      The study consists of four steps:~        -  Step 1. Screening - selecting healthy volunteers for inclusion in the study;~        -  Step 2. Assignment in one of the study group, prescription of the study drug;~        -  Step 3. Samples collections for pharmacokinetic analysis;~        -  Step 4. Evaluation of pharmacokinetic data.~   "
22787|NCT02758899|"~     The purpose of this study is to determine the relevant significance of diabetes on cervical~     disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile~     in patients undergoing anterior cervical discectomy and fusion for cervical spondylosis.~     Additionally, to compare the level of degenerative cervical disc glycosylation in patients~     with and without diabetes.~      Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels~     of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor~     outcomes.~   "
22788|NCT02758886|"~     The purpose of this study is to determine whether an animal visitation programs on college~     campuses are effective in the treatment of college student stress reduction during~     preparation for final examinations.~   "
22789|NCT02758873|"~     One in every 11 children in the United Kingdom (UK) has asthma. Children with asthma cough,~     wheeze and have difficulty breathing. The symptoms which children experience can mean they~     miss school and makes it difficult for children to take part in playground games and sports.~     Some have to be admitted to hospital. In fact, in the UK a child is admitted to hospital~     every 18 minutes because of their asthma.~      Effective medicines are available, but a child's response to these medicines is currently~     unpredictable. This project focuses on an asthma controller medicine called salmeterol.~     According to reports, tens of thousands of children may be taking this medicine in the UK,~     but evidence suggests it might not work for around one in seven of them. The study team are~     investigating whether a new approach to treatment, where prescribing is personalised~     according to a child's genetic make-up, improves the child's quality of life and provides~     better control of their asthma. Treatment that is tailored in this way to a person's genetic~     features is often called 'personalised medicine'.~      At the moment, doctors commonly prescribe salmeterol to relieve asthma symptoms if children~     do not benefit enough from other medicines. But evidence suggests salmeterol may not work~     properly in children with a certain genetic makeup.~      The study team are investigating whether it helps to take children and young people's~     genetic makeup into account when deciding whether to give them salmeterol or an alternative~     medicine called montelukast. A simple and inexpensive saliva test can provide the~     information needed to guide decision making.~   "
22790|NCT02758860|"~     The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic~     classification for diverticulosis and diverticular disease of the colon.~      The aim of the study is to show that DICA classification is a valid parameter to predict the~     risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients~     suffering from diverticulosis/diverticular disease of the colon.~   "
22791|NCT02758847|"~     The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and~     tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel~     coated balloon angioplasty in the tibial arteries was terminated. The investigators~     objective is to establish the safety and efficacy of drug coated balloon (DCB) for~     femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue~     loss.~      The investigators objective is to establish the safety and efficacy of drug coated balloon~     (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI)~     and tissue loss.~   "
22792|NCT02758834|"~     The purpose of this study is to determine plasma phytosterols half-lives in preterm infants~     who received intravenous soy oil-based lipid emulsions.~   "
22793|NCT02758821|"~     PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC)~     testing on health care worker prescribing behaviour in patients presenting to primary~     healthcare centres with an acute fever or recent history of fever.~      SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14~     days of follow-up.~      To assess the correlation between CRP results and clinical outcomes on the day 5 of the~     enrolment.~      To estimate the impact of CRP testing on antibiotic consumption after first consultation.~      To explore the attitudes of health centre staff towards the POC CRP test. To identify the~     prevalence of key pathogens in febrile patients in these settings.~      To validate the ability of CRP to discriminate between viral and bacterial pathogens in a~     subset of patients with a microbiologically confirmed diagnosis.~   "
22794|NCT02758808|"~     The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000~     patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US.~     The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to~     have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of~     well-characterized patients with interstitial lung disease (ILD) for participation in~     retrospective and prospective research~   "
22796|NCT02758782|"~     To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) -~     Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as~     compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the~     spine over two years in patients with ankylosing spondylitis (AS).~   "
22798|NCT02758756|"~     The proposed study will assess whether either massage or an Integrative Medicine practice~     called Reiki can alleviate fatigue in subjects receiving hormonal treatments. Reiki is~     classified by the National Center for Complementary and Integrative Health as a~     biofield/touch therapy, and Reiki practitioners believe that their gentle therapy promotes~     healing and well-being by unblocking and balancing energy flow and re-establishing~     homeostasis within the human energy field. The study is a three-arm randomized clinical~     trial in 99 breast and prostate cancer patients who are undergoing hormonal therapy (i.e.,~     androgen deprivation therapy (ADT) for males or an aromatase inhibitor (AI) for females) and~     currently experiencing fatigue. Subjects will be studied during ten weeks of hormonal~     therapy with two weeks of baseline assessments followed by a four-week intervention, and a~     four-week post-intervention period. Arm 1: Subjects will receive two Swedish-style massages.~     Arm 2: Lower-dose Reiki intervention - Subjects will receive two Reiki treatments. Arm 3:~     Higher-dose Reiki intervention - Subjects will receive four Reiki treatments.~   "
22799|NCT02758743|"~     The purpose of this study is to validate the novel hypothesis that regular use of Acetium~     Lozenge is promising novel method to assist in smoking cessation.~      The aim of this confirmatory study is to affirm the promising results obtained in a previous~     smoking intervention trial with Acetium lozenge. If successful, the trial gives adequate~     power to confirm, that the Acetium lozenge represents a breakthrough in the development of~     smoking intervention methods.~   "
22800|NCT02758730|"~     This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase~     I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of~     AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment~     period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment~     groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg~     aluminium oxide).~      Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A~     or placebo during the participation in the clinical trial. Patients will either receive 75~     µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The~     treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male~     and female patients aged 40 to 80 years can participate in the trial.~      AFF010 is part of the project MULTISYN funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).~   "
22801|NCT02758717|"~     This phase II trial studies how well nivolumab and brentuximab vedotin work in treating~     older patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab,~     may block cancer growth in different ways by targeting certain cells. Biological therapies,~     such as brentuximab vedotin, use substances made from living organisms that may stimulate or~     suppress the immune system in different ways and stop cancer cells from growing. Nivolumab~     and brentuximab vedotin may work better in treating older patients with untreated Hodgkin~     lymphoma.~   "
22802|NCT02758704|"~     This study will be a randomized controlled trial designed to analyse the impact of stress on~     the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric~     residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS)~     environment where they will be asked to perform a standard neonatal intubation procedure.~     Subjects will then cross-over to the second scenario within a short window (1-2 weeks).~     Outcome measures include: endotracheal intubation success rate and assessment of the~     procedure performance by video-review using a standardized checklist rated by two~     independent reviewers. Stress level will be measured using salivary cortisol, heart rate and~     a standardized anxiety questionnaire.~   "
22803|NCT02758691|"~     Recent research has suggested insulin may be involved in how human's form and recall~     memories. This study is designed to look at how nasal insulin is used in the brain.~     Specifically, how insulin alters the various connections within brain regions that occur~     while adults perform simple attention and memory tasks. This study is divided into two~     parts: blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The~     blood draw procedure is designed to look at the effects of intranasal insulin using a~     Precision Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those~     asked to participate will receiving a low-dose saline solution and low-dose of insulin~     through a nasal spray followed by a blood draw session to measure your blood glucose and~     insulin levels over a 90 minute period.~      Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve~     receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision~     Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI).~     During the scan, participants will complete a series of memory tasks reflected on a computer~     screen. The trial will be randomized and double-blinded.~   "
22804|NCT02758678|"~     Purpose:~      Selectins are vascular cell adhesion molecules involved in adhesive interactions of~     leukocytes and platelets and endothelium within the blood circulation.~      Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion~     molecule and component of the membrane of the platelet alpha granulate has been proposed as~     a one marker of platelet activation. In this study we evaluate of expression of P selectin~     on platelets of blood between serum samples from lung cancer and healthy individuals.~   "
22805|NCT02758665|"~     A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus~     obinutuzumab in physically fit (CIRS ≤ 6 & normal creatinine clearance) and unfit (CIRS > 6~     & creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic~     leukemia (CLL) with TP53 deletion (17p-) and/or mutation~   "
22839|NCT02758223|"~     PACT is a non-randomized multicentre phase I/II study to evaluate the feasibility and safety~     of the prophylactic administration of donor derived TCM. Patients with Acute Myeloid~     Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are planned to undergo a HLA -matched~     (9/10 or 10/10) allogeneic hematopoietic stem cell transplantation and who are either 50+~     years old or have a high comorbidity score are included according to criteria as described~     below. TCM will be applied in escalating doses to a maximum of 30 patients who have received~     T cell depleted Human leukocyte antigen (HLA)-matched alloHSCT grafts and qualify for TCM~     transfer.~   "
22840|NCT02758210|"~     The purpose of this study is to evaluate the effects of Electromagnetic field exposure using~     a Tablet on MICRA device (leadless pacemaker) as well as study the effects of~     Electromagnetic field exposure using a smart phone on MICRA device.~   "
22806|NCT02758652|"~     Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries~     and the fifth most common cause of cancer-related death in women. Poor prognosis is due to~     challenges in early diagnosis and development of inevitable resistance to chemotherapy in~     majority of patients despite of good initial treatment response. The purpose of this~     prospective study is to analyze variation in microRNA expression in prediction of primary~     treatment response and the role of microRNAs in development of chemoresistance in epithelial~     ovarian cancer.~      • Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor~     samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for~     microRNA expression and differential expression is correlated with primary treatment~     response, progression-free survival and overall survival.~      • Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or~     diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or~     adjuvant chemotherapy and at progression for high-throughput screening of microRNA~     expression by array technology.~   "
22807|NCT02758639|"~     Parental cancer can cause substantial behavioral and emotional distress in both parent and~     child. Parents struggle with talking with their child about their cancer and supporting the~     child during treatment. Over 73% of patients with children desire information and services~     to support their children yet only 9% of these families report receiving this support. The~     purpose of this study is to evaluate the Wonders & Worries psychosocial intervention~     designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This~     study is a randomized controlled clinical trial (RCT) evaluating the Wonders & Worries group~     and individual intervention for school age children (5 -14 years old) who have a parent with~     cancer. Families will be enrolled at the time of initial parent consultation, given informed~     consent, and then randomized either to the intervention group of 30 families or the~     wait-listed control group of 30 families. Both groups will be given a series of standardized~     validated assessment instruments including the Revised Children's Manifest Anxiety Scale~     (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at~     baseline, post intervention, and 8 week follow up. Upon completion of the follow up~     measures, families in the wait-listed control group will be enrolled into the intervention.~     Parent exit interviews for both groups will be used to measure parent-reported child~     outcomes and program utility.~   "
22808|NCT02758626|"~     This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet~     syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant~     epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment~     period. Treatment Period 1 will be followed by a 4-week Washout Period. Based on ataluren PK~     and pharmacodynamic data, the 4-week washout period is deemed an appropriate length of time~     to eliminate any ataluren drug effects. Following the Washout Period, patients will~     crossover to receive the opposite treatment during Treatment Period 2 as follows: Patients~     receiving ataluren during Treatment Period 1 will receive placebo during Treatment Period 2.~     Patients receiving placebo during Treatment Period 1 will receive ataluren during Treatment~     Period 2.~   "
22809|NCT02758613|"~     The main purpose of this study is to investigate the safety and tolerability of the study~     drug known as LY3009104 in healthy Chinese participants. The study will measure how the body~     absorbs, breaks down and gets rid of LY3009104. The study will last about 20 days, not~     including screening. This study is for research purposes only, and is not intended to treat~     any medical condition.~   "
22810|NCT02758600|"~     Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and~     greater quality of life in patients with coronary arterial disease. Evidences on the~     cardiovascular and gas-exchanges responses during and right after early exercise-based~     rehabilitation of this patients are limited. Objective: The investigators aim to analyse~     breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT)~     and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD)~     after CABG. In addition, the investigators will investigate oxygen consumption and~     cardiopulmonary responses during the early exercise-based rehabilitation in the first days~     after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects~     will be allocated into two groups: with LVD (LVEF < 45%) and without LVD (LVEF > 45%).~     Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric~     device before and 6 days after CABG. During the first days after surgery, patients will be~     evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption~     during the portable cycle ergometer protocol. Clinical outcomes as time to hospital~     discharge, pulmonary complications and occurence of arrythmias will be assessed during~     inpatient time until hospital discharge. Incidence of mortality, hospital readmission and~     angina recurrence will be evaluated in a one-year follow up.~   "
22811|NCT02758587|"~     This study will explore whether defactinib (a FAK inhibitor) can be safely and tolerably~     combined with pembrolizumab (a PD-1 inhibitor) and will look for early indications of~     improved anticancer immunotherapy. It will focus on three key cancers, all in clear need of~     improved therapies - NSCLC, pancreatic cancer and mesothelioma.~   "
22812|NCT02758574|"~     The study will compare standard catheter directed thrombolysis to ultrasound accelerated~     thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study~     population will include patients eligible for catheter directed thrombolysis (CDT) for~     submassive PE. Subjects will be randomized to, either, standard catheter-directed~     thrombolysis or ultrasound-accelerated thrombolysis (USAT).~   "
22813|NCT02758561|"~     This pilot study will assess the feasibility and acceptability of an educational workshop on~     pelvic floor disorders and its potential impact on decisional conflict.~   "
22814|NCT02758548|"~     The purpose of this study is to determine the accuracy of the Novel point of care test~     (POCT) total IgE assay in atopic patients.~      120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.~     Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous~     samples will be collected and sent to a reference laboratory for measurement of serum total~     IgE using the reference immunoassay method.~   "
22841|NCT02758197|"~     This randomized controlled trial will evaluate the effectiveness of an interdisciplinary~     treatment approach combining medical management with an online Mindfulness-Based Stress~     Reduction (MBSR) program in reducing disability and improving quality of life among cancer~     survivors living with moderate to severe chronic neuropathic pain.~   "
22815|NCT02758535|"~     Percutaneous image-guided parenchymal renal biopsy has been used to detect the different~     pathologies of renal parenchyma, to define the degree of reversible changes, and to define~     when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to~     have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle~     renal biopsy is usually based on tissue sampling under guidance of either sonography or~     computed tomography. Renal parenchymal biopsy can be done either with a coaxial or~     noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal~     parenchyma; then, multiple tissue sampling can be performed throughout the same tract.~     Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue~     sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial~     methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has~     not yet been described in the literature. In this prospective study, the investigators~     sought to compare the procedural time and the complication rate of coaxial technique with~     those of noncoaxial technique in percutaneous renal parenchymal biopsy.~   "
22816|NCT02758522|"~     The objective of this study is to compare the therapeutic efficacy of three regimens of~     insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.~   "
22817|NCT02758509|"~     Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV~     antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon~     (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low~     efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease~     inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR),~     improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting~     antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies~     evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical~     practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and~     safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine~     practice according to European guidelines from 2010 to 2015. The secondary aim is to~     evaluate the impact of sustained virological response on gastroesophageal varices (GOV).~   "
22818|NCT02758496|"~     The purpose of this study is to evaluate the safety and efficacy of Magnetic EEG/ECG-Guided~     Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).~   "
22819|NCT02758483|"~     BACKGROUND: The treatment with continuous glucose monitoring system (CGMS) offers improved~     glycemic control for patients with type 1 diabetes. However, patients with type 1 diabetes~     usually intake foods with sugar, even without hypoglycemic episodes, and the use of advanced~     carbohydrate counting method may increase the calories and carbohydrate intake.~      OBJECTIVE: To evaluate and compare the influence of sucrose-free diet or sucrose-added diet~     on glucose variability in patients with type 1 diabetes.~      METHODS: The study was a simple-blind, two-way crossover design in which patients with type~     1 diabetes will receive a control diet (a diet with a little quantity of sugars) or test~     diet (with foods containing moderate quantity of sucrose in composition) during two-days~     each. During the intervention, all foods and drinks intake will have to be documented to~     allow quantitative estimation of dietary intake, to verify adherence to the diets. After~     one-week, each patient will return for download CGMS.~      PURPOSE: The research proposal adds knowledge about the glucose variability in patients with~     type 1 diabetes who use foods with sugar in theirs habitual dietary intake.~   "
22820|NCT02758470|"~     The objective of this research is to assess the effects of acetazolamide and methazolamide~     on respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted~     for the respiratory and plantar flexor muscles and the difference in pressure/torque~     produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.~   "
22821|NCT02758457|"~     The objective of this study was to compare the 5-year survival and clinical behavior of~     single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal~     framework. If failures occurred, the further aim of the study was to delineate the factors~     contributing to the failure. The null hypothesis stated that the survival of zirconia-based~     restorations would be no worse that those made with metal-based material.~   "
22822|NCT02758444|"~     The overall objective is to determine the impact of EED on total daily zinc absorption of~     young Bangladeshi children (18-24 months of age) in an austere setting with high rates of~     diarrhea, stunting, and micro-nutrient deficiencies..~   "
22823|NCT02758431|"~     This study plans to learn more about heart and vascular aging in men. In some men as they~     get older, testosterone levels fall below the normal range for young men. Also, as men get~     older cardiovascular health worsens. This can lead to high blood pressure and heart disease.~     In this study we want to find out what causes cardiovascular health to worsen in older men.~     Also we want to find out what happens when testosterone levels are lowered for a short time.~     Specifically, we want to see if the reduction in cardiovascular health in older men with low~     testosterone levels is because of damage to mitochondria. Mitochondria are the main power~     supply of the cells in our body. The results from this study will help to understand why~     cardiovascular health declines in older men with low testosterone levels compared to younger~     men and older men who have higher testosterone levels. Knowing this information will help to~     develop therapies to prevent heart disease in men.~   "
22824|NCT02758418|"~     The purpose of this study is to determine the differential efficacy and effectiveness of a~     self-help treatment for adjustment disorders administered in two different formats: 1)~     computerized program applied over the Internet and 2) traditional bibliotherapy sent by~     e-mail. In addition, both treatment modalities included in the study will be compared with a~     waiting list control group.~      It is expected that, on the one side, both intervention groups will improve significantly~     compared to the waiting list control group, and the computerized program applied over the~     Internet will be more effective than the treatment through traditional bibliotherapy sent by~     e-mail. On the other side, it is expected the self-applied online treatment program to have~     less drop-outs and be better accepted and valued by the patients than the bibliotherapy~     condition.~   "
22842|NCT02758184|"~     The Purpose of this study is to identify added value of Rotational thrombo-elastometry~     (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major~     reconstructive spine surgery.~   "
22825|NCT02758405|"~     Brief Summary:~      Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered~     with a pump that could only provide continuous infusion of the freezing medication in~     combination of pushes of medication activated by the patient, a technique called patient~     controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested~     that this continuous infusion of medication is not as effective as previously thought, and~     suggested that instead of continuous infusion, intermittent programmed pushes should be~     used. The investigators now have devices that are able to do that. Programmed intermittent~     epidural bolus (PIEB) is a new technological advance based on the concept that boluses of~     freezing medication in the epidural space are superior to continuous epidural infusion~     (CEI). The investigators are currently using pumps set up with PIEB, in addition to what the~     patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this~     manner prolong the duration of analgesia, reduce motor block, lower the incidence of~     breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption.~     The investigators have recently concluded a study at MSH using PIEB where they observed~     excellent results. However, some patients exhibited higher than necessary sensory blocks.~     The investigators believe that the technique can be optimized by using the same dose of the~     freezing medication, but using a smaller volume of local anesthetic at a higher~     concentration. This optimization may also further reduce the amount of medication used by~     each patient.~      The hypothesis of this study is that there is an optimal interval time between PIEB boluses~     of 30 to 60 minutes at a fixed volume of 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml~     that will provide women the necessary drug requirements, thus avoiding breakthrough pain and~     need for PCEA or physician intervention.~   "
22826|NCT02758392|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose~     administration and a single Subcutaneous (SC) dose administration in healthy participants.~   "
22827|NCT02758379|"~     The objective of this clinical trial is to study the early safety and feasibility of the~     Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely~     and effectively deliver localized shockwave energy for balloon dilatation of calcified,~     stenotic, de novo coronary lesions.~   "
22828|NCT02758366|"~     The standard therapy of glioblastoma (GBM) consists of gross total resection followed by~     focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The~     association of valproic acid and TMZ during radiotherapy improves survival of GBM.~     Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against~     human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines~     in patients with solid tumor ensured a better safety profile compared with bolus~     administration.~      Based on these findings, the purpose of this study is to evaluate safety and efficacy of~     prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and~     valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic~     pontine glioma (DIPG).~   "
22829|NCT02758353|"~     The purpose of this study is to test the feasibility of the scale-up of sulphadoxine-~     pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local~     Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the~     introduction of community-based distribution of SP in addition to ongoing health facility~     distribution during antenatal care (ANC) visits. In addition, the study examined for the~     effect of SP use by participants during pregnancy on the head circumference of live newborns~     and on the odds of a baby being a stillborn. Finally, the investigators also sought to~     quantify the costs associated with program scale up SP to deliver at least three doses of SP~     per participant via a government operated distribution program.~   "
22830|NCT02758340|"~     The study will compare the number of women who deliver vaginally after artificial initiation~     of labor pains(i.e. induction of labor) by two methods. Half of the women would receive~     tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's~     balloon catheter both.~   "
22831|NCT02758327|"~     The objective of the study is to demonstrate a change in osmolarity over time when moderate~     to severe dry eye subjects are treated with TheraTears lubricating drops.~   "
22832|NCT02758314|"~     Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating~     T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1~     (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer~     patients, particularly in those with lung cancer, has not been sufficiently studied. The~     purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of~     peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC),~     associating with clinicopathological features of the patients studied.~   "
22833|NCT02758301|"~     The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients~     with heart failure by assessing the relationship between changes in LINQ™ derived data and~     other physiologic parameters with subsequent acute decompensated heart failure (ADHF)~     events.~   "
22834|NCT02758288|"~     The investigator's aim in this study is to evaluate the impact of a new standard of care~     protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching~     from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with~     BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular~     filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.~   "
22835|NCT02758275|"~     The purpose of this study is to improve the adherence of therapeutic regimen in people with~     hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing~     intervention Teaching: Individual, is more effective to increase adherence of therapeutic~     regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual~     care.~   "
22836|NCT02758262|"~     The goal of this project is to identify brain mechanisms by which Noninvasive brain~     stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver~     NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind~     study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to~     new therapeutic avenues to treat this eating disorder.~   "
22837|NCT02758249|"~     Anesthetics agents has an effect on immune response during the cancer surgery.This influence~     can regulatory to immune activity or cancer cell survival.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
22838|NCT02758236|"~     This study is a prospective observational cohort study of TB patients who are treated or~     evaluated at 7 study sites. Patients presenting with cough for 2 weeks or longer with at~     least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be~     enrolled in the study. The signed informed consent will designate their willingness to~     participate on this study.~   "
22844|NCT02758158|"~     Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using~     ultrasound imaging and surgery is the most common treatment. However, most nodules are~     benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound~     imaging is very sensitive for localizing nodules, but does not differentiate between~     cancerous and benign ones. To address this limitation of US imaging, investigators have~     designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel~     imaging system that performs complimentary imaging modalities (ultrasound (US),~     photoacoustic (PA)) that could potentially help diagnose nodules without the need for biopsy~     and unnecessary surgery.~   "
22845|NCT02758145|"~     The investigators will compare two groups, an intervention group with a control group. Each~     employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic~     of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the~     CHUV between 04/25/16 (end of previous influenza epidemic) and 31/10/16 (the day before the~     start of the next influenza vaccination campaign) and exert a function in regular contact~     with patients will be eligible. Depending on his employee number (assigned by the human~     resources administration, independent of any parameter), he will be placed in the~     intervention group G1 (odd number) or in the control group G2 (even number). The information~     concerning the distribution of these two groups will be noted in the computerized medical~     records of the employee at the occupational medicine unit (Medipho4D software, secured~     database). Thereafter, the employee will be received by the nurse of the he occupational~     medicine unit for a recruitment visit according to the usual process. The nurse will perform~     the study intervention in addition to the usual procedure if it is stipulated ''intervention~     group'' on the employee's record in the database or only perform the usual steps if it is~     stipulated ''control group''. At the beginning of the next influenza vaccination campaign~     (mid-November 2016), employees in the intervention group will receive a letter reminding~     then about the intervention given during the recruitment visit and inviting them to get~     vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of~     the influenza epidemic that will follow (April 2017), each employee will have the~     opportunity to be vaccinated at the different vaccination stalls set up by the occupational~     medicine unit. For each employee vaccinated, the date of vaccination and vaccine name is~     entered in the electronic medical records of the occupational medicine unit (Medipho4D~     software) by a nurse or a secretary of the unit. At the end of the human influenza epidemic~     (April 2017), the data will be extracted from the database (Medipho4D software) and~     anonymized by an individual not implicated in the study. Data from two groups will be~     analyzed and compared to assess whether the intervention conducted among newly hired~     employees promotes influenza vaccination.~   "
22846|NCT02758132|"~     This is a correlative study to characterize serum metabolites associated with bone~     deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not~     currently receiving bone targeting agents.~   "
22847|NCT02758119|"~     The objective of this study is to compare two forms of pre-training (an online narrative~     presentation and a serious game) to prepare 2nd year medical students for a hands-on~     training with physical simulators about out-of-hospital cardiac arrest management.~   "
22848|NCT02758106|"~     BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving~     mechanical ventilation may reduce expectoration function. High frequency chest wall~     oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous~     oscillation may influence ventilator settings and change instantaneous cardiopulmonary~     responses. The aim of this study was to investigate these issues. METHODS: Seventy-three~     patients aged >20 years who were intubated with mechanical ventilation for pneumonic~     respiratory failure were recruited and randomly classified into two groups (HFCWO group,~     n=36; and control group who received conventional chest physical therapy (CCPT), n=37).~     HFCWO was applied with a fixed protocol, while CCPT was conducted using standard protocols.~     Both groups received sputum suction after the procedure. Changes in ventilator settings and~     the subjects' responses were measured at pre-set intervals and compared within groups and~     between groups.~   "
22849|NCT02758093|"~     As people age with HIV, the synergistic effects with normal age-related cognitive declines~     will accentuate and/or accelerate declines in cognitive functioning which can be detected as~     early in one's 40s. Although interventions are needed to protect/improve cognitive~     functioning, one intervention already exists to improve speed of processing. NINR/NIA~     (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N =~     2,802 community-dwelling older adults) has the ability to enable older people to maintain~     their cognitive abilities as they age even 10 years after training. As shown in the ACTIVE~     Study, this intervention uniquely improves driving, instrumental activities of daily living~     (IADL), health-related quality of life, self-rated health, internal locus of control, and~     protects one from depression; these represent areas of needed intervention for adults with~     HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of~     processing declines are associated with poorer driving simulator performance and more~     self-reported at-fault automobile crashes; such speed of processing declines on driving~     alone represent a significant public health concern. These studies also demonstrated that~     Speed of Processing Training improved this cognitive ability and translated into improved~     performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists~     of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+~     years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned~     to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing~     Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a~     standardized computer-contact control (sham) condition.~      AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this~     cognitive ability at post-test, year 1, and year 2 after baseline.~      AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve~     everyday functioning at post-test, year 1, and year 2 after baseline.~      Exploratory AIM: Determine whether improvement in speed in speed of processing and/or~     everyday functioning over time mediate improvement quality of life (e.g., depression, health~     related quality of life).~   "
22850|NCT02758080|"~     A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had~     failed, is identified using next generation sequencing. Patients are assigned to early~     clinical trials of targeted agent based on the molecular profiling or physician's choice.~     The improvement of outcomes in the intention-to-treat population is investigated.~   "
22851|NCT02758067|"~     To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is~     non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.~   "
22852|NCT02758054|"~     The study proposes to evaluate a patient navigation intervention among a sample of 340~     individuals referred for CT-based lung cancer screening in an urban safety-net setting.~   "
22853|NCT02758041|"~     This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial~     inflammatory acne vulgaris.~   "
22854|NCT02758028|"~     The aims of the present study are:~        1. To raise the awareness of smoking cessation service among youth smokers in Hong Kong;~        2. To provide smoking cessation quitline service to youth smokers; and~        3. To provide training to teenagers as peer smoking cessation counsellors.~   "
22855|NCT02758015|"~     Food will decrease stomach acidity due to its buffering effect.This has implications when~     providing drugs that are dosed with food but require higher levels of stomach acid, such as~     some medications commonly used for HIV patients. This study will attempt to determine the~     dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food~     on stomach acid could be countered. Additionally, this study will evaluate the ability of a~     natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized~     meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride~     will have the greatest effect on gastric pH.~   "
23535|NCT02749123|"~     A comparison of transdermal patches for efficacy, side effects and quality of life for~     patients with back pain and arthritis. The three arms in the trial were; prescription~     strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.~   "
22856|NCT02758002|"~     There is growing awareness of the importance of electrical rotors to the maintenance of~     atrial fibrillation (AF). Recent work in our laboratory has found that AF evolves over time,~     from rapid, focal activation, next to transitional rotors, and finally to stable, long~     duration rotors, whose locations are frequently separate from the transitional rotor sites.~     This project will test the hypothesis that mapping and ablation of the transitional rotors~     sites may prevent atrial fibrillation from progressing to sustained atrial fibrillation, and~     therefore increase the AF initiation threshold. The investigators will test this hypothesis~     during clinically-indicated electrophysiology study prior to ablation of symptomatic AF.~   "
22857|NCT02757989|"~     Comparison of survival in patients with or without a matched donor at 36 months~   "
22858|NCT02757976|"~     This trial will compare two strategies for patients with Heart Failure, Left Ventricular~     systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT.~     The experimental group is LVendo CRT~   "
22859|NCT02757963|"~     This non-randomized, interventional study will be conducted in a general practice setting to~     assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction~     (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men~     confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may~     help a General Practitioners (GP) to identify subjects who may have BPH for further tests~     and improve the speed of referrals to specialists when this is appropriate. The utility of~     the screening tool will be compared to the validated tool in wide clinical use, the~     International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis~     in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool~     identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting~     with LUTS. The results of this screening tool will be used for further investigation. All~     subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS~     (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis~     of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE)~     which will be repeated by the urologist to confirm the diagnosis and to rule out an~     abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based~     upon screening results and lab tests which suggest that they are related to BPH and not~     other causes of such symptoms. The GP will phone the subject to report yes or no for~     probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the~     subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it~     will be considered that the subject has completed the study. Subjects that proceed to Part~     II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This~     assessment includes a DRE and a brief physical exam and review of the PSA test, for a~     confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately~     1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for~     probable BPH to yield 500 subjects being referred to an urologist. The duration of the study~     will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit~     scheduling.~   "
22860|NCT02757950|"~     The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered~     during pregnancy in a maternal immunization program in Brazil.~   "
22861|NCT02757937|"~     Diabetes is one of the most common chronic illnesses among adults in the United States.~     Internet-based interventions and health promotion websites for patients with Type 2 Diabetes~     are typically low-cost, easily accessible, and attractive. The purpose of this study is to~     determine whether participants' utilization of a health & wellness website focused on~     diabetes self-management increases participants' self-reported self-efficacy toward managing~     their Type 2 Diabetes through behavior change and self-reported medication adherence~     compared to standard care.~   "
22862|NCT02757924|"~     To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on~     symptoms of formula intolerance in healthy term infants.~   "
22863|NCT02757911|"~     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects~     boys. It is a primary immunodeficiency disorder which results from an inability of the white~     blood cells called phagocytic cells (or phagocytes) to kill invading bacteria and fungi.~     These cells have difficulty forming the free radicals (most importantly the superoxide~     radical due to defective phagocyte NADPH oxidase complex) which are important in the killing~     of ingested pathogens. In X-CGD (which accounts for two thirds of CGD patients), the defect~     lies in a gene which makes up a critical part of the NADPH-oxidase complex (the catalytic~     subunit; gp91-phox protein). Therefore they kill bacteria and fungi poorly, and the patients~     suffer from severe and recurrent infections. This also results in inflammation which can~     damage parts of the body such as the lung and gut.~      In many cases, patients can be adequately protected from infection by constant intake of~     antibiotics. However, in others, severe life-threatening infections break through. In some~     cases, inflammation in the bowel or urinary systems results in blockages which cannot be~     treated with antibiotics, and which may require the use of other drugs such as steroids.~     Development of curative treatments for CGD is therefore of great importance.~   "
22864|NCT02757898|"~     The purpose of this research is to study how red blood cells (RBCs) survive in a person's~     circulation, and how that survival may be different in red blood cells that are donated and~     stored prior to being transfused. Investigators will study this by collecting blood samples~     from participants, labeling RBCs with a naturally occurring vitamin, biotin. The RBCs will~     then be re-infused back into the participant and blood samples will be taken weekly for 10~     weeks to assess the number of labeled cells in the samples.~   "
22865|NCT02757885|"~     The purpose of this study is to learn if it is possible and safe to treat persons with~     severe sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte~     antigen (HLA) half-matched related donors. Preparation before transplant includes the~     chemotherapy drugs hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and~     cyclophosphamide. It also includes radiation.~   "
22866|NCT02757872|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 US men and women investigating whether taking dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the~     effects of vitamin D or omega-3 fatty acids on kidney function among participants with~     baseline hypertension.~   "
22867|NCT02757859|"~     This randomized clinical trial studies how well high volume washing of the abdomen works in~     increasing survival after surgery in patients with pancreatic cancer that can be removed by~     surgery. High volume washings may remove free floating cancers present after surgery and~     help prolong survival in patients with pancreatic cancer.~   "
22868|NCT02757846|"~     We propose a radiomics approach to identify prognostic biomarkers of HCC and provide~     patients with some reasonable advice for their therapies.~   "
22919|NCT02757183|"~     The INTELLIH (brand name of the mobile health application) Diabetes Study is to understand~     the usage of a mobile health application, IntelliH, and connected wireless devices such as~     glucometer by the diabetic patients and ascertain if there are any improvements in~     short-term health outcomes.~   "
22872|NCT02757794|"~     Prematurity tends to increase in France in recent years and more children born extremely~     premature infants survive. If severe impairments have stabilized, the majority of former~     extremely premature children have neuropsychological disorders and moderate appearance~     behavior disorder, but with a significant impact both family, school and social persisting~     into adulthood.~      Executive functions (EF), in general, and working memory (MT), in particular, are frequently~     altered in older children preterm infants compared to controls born at term.~      The identification process of loss in certain diseases, as well as improving knowledge of~     brain functioning, and development with the possibility of neuronal plasticity has led~     research teams to develop intervention programs focused on process cognitive qualified of~     remediation cognitive (RC). Schematically, the RC is defined as a rehabilitation or~     altered cognitive functions. MT can be improved by encouraging the operation of the spots~     mental stimulant. These programs are effective on MT but do not have the expected impact on~     other FE, language or nonverbal functions (visuospatial). The functional benefit of~     cognitive remediation remains controversial.~      Improving mental functions untrained as nonverbal MT, attention and secondarily learning is~     possible but still unproven on wide population. Similarly, randomized trials are needed to~     test this type of cognitive remediation among preschoolers old very premature.~   "
22873|NCT02757781|"~     The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual~     in improving attitudes of primary care professionals on the empowerment of patients with~     chronic diseases.~   "
22874|NCT02757768|"~     The purpose of the study is to assess the efficacy, safety, and tolerability of mirabegron~     versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin~     hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia~     (BPH).~   "
22875|NCT02757755|"~     This study will examine the safety of ascending doses of AB-SA01 when topically applied to~     intact skin of healthy adults.~   "
22876|NCT02757742|"~     The purpose of this study is to establish a quantitative LGE mass based scoring system~     (including LGE mass on cardiac magnetic resonance , clinical features, specific medical~     histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated~     cardiomyopathy patients with reduced left ventricular ejection fraction~   "
22877|NCT02757729|"~     This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic~     Dermatitis patients.~   "
22878|NCT02757716|"~     To evaluate addiction remission and addiction transfer after bariatric surgery.~   "
22879|NCT02757703|"~     Various vasoactive drugs are recommended to use in combination with endoscopic variceal~     ligation (EVL) in treating acute esophageal variceal bleeding (EVB). The efficacy and drug~     choice of vasoactive agents under Taiwan's National Health Insurance program remain to be~     validated.~      The aim of this prospective cohort study was to assess the efficacy of somatostatin,~     compared with terlipressin in cirrhotic patients who have acute EVB and received EVL and the~     preference of vasoactive agents in real-world clinical practice.~      From April 2010 through April 2015, cirrhotic patients with significant upper~     gastrointestinal bleeding were screened. Eligible patients with acute EVB were non-randomly~     assigned to receive early administration of somatostatin (group S) or terlipressin (group T)~     infusion, followed by EVL. A decision to use vasoactive drugs depended on the physician's~     favorite. In group S, somatostatin by intravenous bolus (250 μg) followed by 250 μg/hour was~     continued for 3 days. In group T, terlipressin was started with 2mg bolus injection and~     followed by 1 mg infusion every 6 hours for 3 days.~   "
22880|NCT02757690|"~     Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has~     represented a considerable challenge for those approaching this technique. Thus,~     3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the~     early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic~     technology was limited in terms of image quality, so that its use had not been implemented.~     More recently, industry has developed novel 3D systems where the imaging is similar to~     stereoscopic vision, in which the depth perception is achieved by different unique images~     received by each eye. Thus, more recent studies have suggested a possible advantage provided~     by these new 3D systems during laparoscopic performance. However, comparative assessments of~     new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and~     pancreatic field.~      To assess the benefits and harms of use of three dimensional systems versus two dimensional~     systems during laparoscopic distal pancreatectomy.~   "
22881|NCT02757677|"~     The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based~     Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.~   "
22882|NCT02757664|"~     Background: There is no consensus regarding the treatment of insertional tendinopathies. The~     good results of the eccentric training in the management of the non-insertional Achilles~     tendinopathy were not reproducible in the insertional disease. Shock wave therapy is~     described as an alternative to these patients.~      Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents~     better results that the eccentric strengthening associated to placebo.~      Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the~     use of placebo, in parallel groups.~      Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be~     enrolled in a randomized trial. Participants will be divided in two groups, one containing~     the combination of shock wave and eccentric exercises as treatment and the other~     comprehending the exercises assembled to placebo. The assessment of outcomes will occur in~     2, 4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain,~     activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles~     [VISA-A] questionnaire).~   "
22897|NCT02757469|"~     Premature ovarian insufficiency (POI) is a life-changing condition that affects women in~     their reproductive age. There is a lack of reports which focus on how to improve the~     reproductive outcome of these women who wish to conceive spontaneously or use assisted~     conception with their own oocytes. However, one could surmise that it is important to lower~     gonadotropin levels into the physiological range before embarking on any treatment, even if~     natural conception is the only choice for the woman/couple.~   "
23558|NCT02748824|"~     To assess the five-year incidence of AMD in a population from the central region of~     Portugal, previously phenotypically characterized.~   "
22883|NCT02757651|"~     This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen~     peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a~     standard course of radiotherapy in women with poorly controlled symptoms. Laboratory~     research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation~     sensitiser ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers~     under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness~     of standard doses of radiotherapy alone. The side effects are limited to mild/moderate~     discomfort at the injection site for up to 24 hours reported by Japanese breast cancer~     patients in whom this treatment has been tested. Complete tumour shrinkage in 70/71 (98%)~     primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.~   "
22884|NCT02757638|"~     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is~     stable and during weight loss induced by bariatric surgery procedure using the technologies~     of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics) will enable~     generation of new hypotheses that could explain the inter-individual differences in weight~     loss and could lead to optimization and individualization of therapies designed to lose~     weight.~   "
22885|NCT02757625|"~     To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as~     continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to~     <17 years old] requiring sedation under intensive care unit~   "
22886|NCT02757612|"~     The aim of this study was to report the effect of laser diode on the treatment of burning~     mouth syndrome (BMS)~      Patients were randomly allocated to two different groups:~      the first one (group A) underwent Laser diode whereas the second one (group B) received~     Laser diode inactive~   "
22887|NCT02757599|"~     Background: Transvaginal ultrasound training of novices is performed differently with~     respect to the orientation of the ultrasound image. There is no international consensus on~     the orientation of the transvaginal ultrasound image and no evidence to support whether one~     orientation is superior to the other in terms of educational outcome and learning curves.~      The aim of this study is to assess the effects of transvaginal ultrasound training when~     orienting the image top-down versus bottom-up, which can open for the discussion concerning~     a uniform transvaginal ultrasound education. This study may improve ultrasound novices'~     learning and potentially ensure that future clinicians perform transvaginal ultrasound~     examinations in the same manner.~      Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound~     novices, as the most intuitive will result in lower cognitive load during training and~     result in shorter learning curves and improved transfer of skills to various settings and~     cases.~   "
22888|NCT02757586|"~     CLL is a disease of the elderly, identifying effective therapies with better toxicity~     profiles is thus a high priority, and targeted therapies may allow attainment of this goal.~   "
22889|NCT02757573|"~     The aims of the study is to investigate the right ventricular responses to mild hypercarbia~     after mitral valve prolapse repair surgery by the measurements obtained on pulmonary~     arterial catheter and transesophageal echocardiography.~   "
22890|NCT02757560|"~     The overall goal of the proposal is to use a saturated fatty acid (SFA)- enriched, high fat~     diet to rapidly induce insulin resistance (IR) to provide insight into underlying proximal~     mechanisms of reduced insulin signaling. Specifically, investigators will identify the~     initial changes in metabolite concentrations/or pathway signaling (pathways will be used~     to broadly refer to these mechanism specific measures) and therefore the mechanisms most~     likely responsible for the development of IR during this high fat nutritional challenge.~     Investigators have assembled a multidisciplinary team that is versed with dietary studies,~     fatty acid metabolism, measurement of IR and potential mechanisms and mediators of IR, and~     has experience working with monocytes and the two tissues, muscle and adipose tissue, that~     are particularly relevant for understanding the effects of high fat diets on IR.~   "
22891|NCT02757547|"~     The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS~     can induce long term depression in epileptogenic cortex and thus suppress cortical~     excitability at the epileptic focus.~   "
22892|NCT02757534|"~     The purpose of this study is to provide oral domperidone to patients with gastroparesis,~     between the ages of 18 and 60 years of age, who have failed standard treatment. Standard~     therapy at the University of Iowa is eating blended foods, liquid diet, Eryped syrup (125 mg~     TID) 30 minutes before meals, or reglan (20 mg BID).~   "
22893|NCT02757521|"~     Investigators will study approximately 64 patients with Treatment-Resistant Bipolar~     Depressive Disorder, defined as a failure of at least 1 antidepressants in the current~     depressive episode and 2 lifetime medication failures. The study will last approximately 6~     to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour~     long inhalation treatments over a week.~   "
22894|NCT02757508|"~     This study is to gather information on school feeding programs and to measure the effect on~     linear growth and cognitive performance when providing a high-quality milk protein source or~     a combination of a high-quality milk protein source and rice proteins as a nutritional~     supplement to school children in Ghana. Children will receive a meal with a protein powder~     supplement with vitamins and minerals mixed into it. Participation is expected to last for 9~     months.~      1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary~     schools (60 per school). Participants will be randomized to one of four groups: Control:~     Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF~     recommendations.~      For groups 1-3 the same vitamin/mineral mix will be used along with Group 1.~     Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the~     sugar lactose.~      Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk~     protein powder and the plant protein is a rice protein concentrate and the sugar lactose.~      Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein~     powder with the sugar lactose.~      At baseline measurements-weight,height,mid-upper arm circumference,and body composition will~     be taken, fasting blood spot test will be administered to measure levels of Insulin and~     insulin like growth factor, and computer based cognitive testing. Demographic information~     will be collected along with a dietary survey. Primary outcomes are cognitive performance on~     standardized tests and change in height-for-age z-score over the supplementation period, 9~     months total. Questionnaires will be administered to collect demographic data and dietary~     information.~      At the mid-point all measurements will be taken again and cognitive testing will be~     repeated.~      At the end of the study all measurements will be taken again, cognitive testing repeated,~     blood spot samples taken again, and a short survey will be administered about the protein~     powders.~   "
22895|NCT02757495|"~     Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general~     anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%.~     Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different~     strategies have been suggested to decrease the incidence and severity of EA. No gold~     standard technique for treating EA after sevoflurane anesthesia is currently available. The~     main question is can caudal dexmedetomidine be used for this purpose?~   "
22898|NCT02757456|"~     Arterial calcification is very common in the incident hemodialysis population, ranging~     71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis~     population, medial arterial calcification may contribute through increased risk of sudden~     death and congestive heart failure. Applanation tonometry is the method of choice to measure~     pulse wave velocity and pulse wave analysis. The primary objective will be to assess the~     effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter~     and gait speed as the physical functioning parameter. The secondary objectives will assess~     the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP,~     hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin,~     hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.~   "
22899|NCT02757443|"~     There is evidence on the role of the phosphotransfer system in the energy metabolism of the~     heart, with altered energetics playing an important role in the mechanisms of heart failure.~     Phosphocreatine plays an important part in the energy heart system. The investigators have~     just performed a systematic review and meta-analysis of randomized controlled trials (RCTs)~     and matched studies that compared phosphocreatine with placebo or standard treatment in~     patients with coronary artery disease or chronic heart failure or in those undergoing~     cardiac surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as~     improved cardiac outcomes when compared to the control group, however, the quality of the~     included studies was low. Thus, the investigators plan to conduct an exploratory high~     quality RCT to investigate whether providing phosphocreatine compared to placebo improves~     the myocardial protection in high-risk patients scheduled for cardiac surgery and to~     determine the best research endpoint for future trials.~   "
22900|NCT02757430|"~     The objective of this registry is to assess and characterize the use and performance of the~     EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a~     variety of electrophysiological (EP) procedures and clinical settings. This registry will~     assess the clinical performance of the system in a controlled, real-world environment after~     commercial release.~      Up to 500 subjects will be enrolled in up to 50 sites worldwide.~      Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no~     long-term follow-up required for this registry.~      The anticipated registry enrollment is about 6-7 months.~   "
22901|NCT02757417|"~     To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during~     gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein~     result in shorter cystoscopy times.~   "
22902|NCT02757404|"~     Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.~   "
22903|NCT02757391|"~     The goal of this clinical research study is to learn if it is safe to deliver a CD8+T cell~     therapy to patients with advanced gastrointestinal cancers.~      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue~     samples) and blood to help create a T cell immune-based therapy designed specifically for~     you based on what the study doctor and research staff can learn about the type of mutated~     proteins (a type of genetic change) in the tumor.~   "
22904|NCT02757378|"~     This study evaluates whether different explanations given to patients with long lasting back~     pain influence a physical therapy treatment technique. Half of the patients will receive an~     explanation of the proposed treatment technique focusing on how their joints are moving and~     not moving. The second half of the group will receive the same treatment technique as the~     first group, but their explanation of the technique's purpose will focus on how their brain~     interprets the information. The study aims to determine if patients have a different~     response to the treatment based on the words chosen to explain the technique.~   "
22905|NCT02757365|"~     Though the pathogenesis of prostate cancer (PCa) is still obscure, it has been reported, by~     investigators previous studies and some other researches, that PCa is often combined with~     tissue inflammation which is closely related to prostate specific antigen (PSA) level.~     Inflammation could play an important role in the process of occurrence and development of~     PCa, however the mechanism is unknown. Inflammatory cytokines could not only mediate~     inflammatory reactions, but also participate in the growth, proliferation, invasion and~     progression of tumor cells. It has been found that non-steroid anti-inflammatory drugs~     (NSAIDs), such as aspirin, can effectively prevent several inflammation related tumor, and~     coincidentally, PCa is also closely associated with inflammation. Moreover, latest~     researches demonstrated that hormone therapy could induce tissue inflammation in PCa, in~     which a large quantity of immune B cells were attracted into the focal and then a lot of~     cytokines, such as IKK-β, NF-κB, were released. These cytokines could inhibit apoptosis and~     promote the growth of tumor cells, which might be a possible mechanism for long-term~     inflammatory infiltration inducing the occurrence of PCa and the transformation to~     castration-resistant prostate cancer (CRPC). Based on these proofs, investigators presume it~     could be possibly an effective way to prevent the occurrence of PCa and the transformation~     from androgen-dependent prostate cancer to CRPC by means of long-term oral aspirin. In this~     study, investigators intend to explore the possible effect of anti-inflammatory therapy on~     the progress of transformations from inflammation to PCa and from androgen-dependent~     prostate cancer to CRPC. Investigators plan to conduct both clinical trials in four groups,~     including the control group, the NSAIDs group, the antibiotics group and the~     NSAIDs+antibiotics group, and a basic experiment in vitro to assess the effectiveness of~     anti-inflammatory drugs and elucidate the specific molecular mechanism.~   "
22906|NCT02757352|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve~     participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).~   "
22907|NCT02757339|"~     This study aims to evaluate the neurobiological basis of traumatic dissociation in a~     cross-diagnostic sample of women who have histories of childhood abuse and neglect.~   "
22914|NCT02757248|"~     This is a phase I study of the combination of volasertib and romidepsin in patients with~     relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell~     lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this~     combination by treating cohorts of patients at a certain dose combination. The investigators~     will use a Bayesian design to determine the dose combination for the next cohort of patients~     and to determine the MTD. Overall response rate as well as adverse events will be monitored~     and reported.~   "
22915|NCT02757235|"~     The study will be a multicenter randomised controlled trial of the use of irrigation fluid~     of body temperature versus irrigation fluid of room temperature during burr hole evacuation~     of chronic subdural hematoma.~   "
22916|NCT02757222|"~     The primary objective of the study is to establish the safety of using a moderate escalation~     of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative~     radiotherapy.~      The study will also explore the efficacy (improvement in complete response rates at 2 years)~     of dose escalation in intermediate and high risk OPC and LH cancers patients.~   "
22908|NCT02757326|"~     This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of~     sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple~     myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been~     treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses~     of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which~     is known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated~     to two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual~     reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used~     to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up~     to 56 additional patients will be treated on the phase II portion of the study at the MTD or~     maximum dose used in phase I, with interim stopping rules for futility.~      Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on~     Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640,~     at the end of cycle #3 and at the end of cycle #6. In addition to serum protein~     electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain~     measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2)~     activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.~   "
22909|NCT02757313|"~     Marijuana is one of the most widely used substances. However, marijuana intoxication is not~     fully understood in relation to driving. This study will help the investigators learn more~     about the potential impairments related to marijuana intoxicated driving. A combination of~     MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to~     measure intoxication and impairment. This study will also assess levels of marijuana in~     blood and saliva samples. This study takes place in Hartford, Connecticut.~   "
22910|NCT02757300|"~     After approval of the Institutional Review Board and written patient´s informed consent~     patients with indication for surgery of the sinuses were randomly assigned to one of the two~     study groups. After standardized anaesthetic management and PONV prophylaxis routinely~     applied the patients were screened for mucosal injury on second postoperative day.~     Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV~     were recorded throughout the hospital stay.~   "
22911|NCT02757287|"~     Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily~     injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th~     stimulation day until ovulation induction with a bolus of another injection of a~     gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid~     untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular~     aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone~     (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single~     subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the~     other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for~     contraception, avoiding the LH surge. It has been described the usefulness of orally~     administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF~     patients during COS.~      In donors, by administering a single injection of FSH-CTP and oral desogestrel since the~     first menstruation day, the total number of injections administered is reduced and less~     discomfort is experienced without adverse impact on ovarian response. No description of the~     hormonal and ovarian response under this protocol has been published~   "
22912|NCT02757274|"~     This will be a prospective collection of pre-defined parameters on the treatment of male~     stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The~     data collection will be undertaken from multiple centers in Europe. The participation will~     be by open invitation to all members of the Female & Functional Section of the EAU (ESFFU)~     along with other urologists undertaking these procedures. There will be a call via the~     European Association of urology (EAU) to all European Urologists to register for database~     entry. There will be no restriction on the number of patients enrolled as long as they are~     consecutive. The aim is to have a long term collection of the data set from as many centers~     as possible. An initial assessment for the robustness of the data collection will be~     undertaken at 3 months by a nominated steering committee. However, the first clinical~     evaluation of the data collected will commence at 1 year by the steering committee.~     Thereafter, the evaluations will be performed after every 2 years.~   "
22913|NCT02757261|"~     Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or~     clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed~     controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol~     in children aged six to eight years with bruxism. The children will be randomly allocated to~     four groups, each with 19 participants: Group 1 will receive low-level laser therapy at~     acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser~     therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm,~     0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture~     points on each side. The BTS TMJOINT electromyograph will be used to determine muscle~     activity and a digital gnathodynamometer will be used to measure bite force. Two saliva~     collections will be performed in the participant's home at 9 am and prior to going to sleep,~     with at least one hour of fasting and followed by oral hygiene with water. Evaluations will~     be performed before as well as one and six months after treatment. The findings will be~     computed and submitted to statistical analysis. Descriptive statistics will be used first~     for the determination of point estimates, precision and validation using analysis of~     variance (ANOVA) for the evaluation of residuals and parametric tests will be used for the~     determination of pre-treatment conditions. Interval estimates will be used for the variables~     of interest to determine the prevision of the estimates and perform comparisons. When~     necessary, transformation methods or non-parametric tests will be used in the data analysis.~     The chi-square test, Student's t-test and ANOVA will be employed, with the level of~     significance set at 5% (p < 0.05).~   "
22917|NCT02757209|"~     This is a randomized, multi-center, active-controlled, repeated measures design study in~     male and female patients 60 years of age and older with persistent asthma or COPD.~      Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano~     delle Murge (Ba), Tradate.~      The primary efficacy parameter of the study is inhaler device usability (expressed as total~     number of repeated attempts required to achieve optimal use).~   "
22920|NCT02757170|"~     Patients of acute & chronic liver failure have long been assumed to have coagulopathy & are~     given blood products prophylactically as well as during various interventions. But these~     patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation~     parameters are insufficient to assess coagulation status of these patients because they~     reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives~     a comprehensive report of hemostatic profile including platelet function. Studies using TEG~     have suggested that defects in prohemostatic drivers are counterbalanced by changes in~     antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a~     entity with acute decompensation on underlying chronic liver failure. Since there is paucity~     of data regarding coagulation abnormalities in these patient, study is needed to assess~     predictability power of TEG in these patients with respect to coagulation abnormalities in~     patient with ALF and CLD ( cirrhosis) and healthy controls.~   "
22921|NCT02757157|"~     The purpose of this study is to evaluate the metabolic load during a single session of~     moderate intensity walking in water compared to walking on land (over-ground) in people with~     chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with~     peak exercise metabolic response.~      The hypothesis is that the metabolic load of walking at a moderate intensity in water will~     be greater than walking on land.~   "
22922|NCT02757144|"~     This is a dose block-randomized, double-blind, placebo- and active-controlled, single and~     multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in~     healthy male volunteers.~   "
22923|NCT02757131|"~     Bedrest and lack of mobility in the inpatient hospital setting hastens the functional~     decline of elderly patients and is associated with increased risk of complications such as~     falls, delirium, venous thrombosis, and skin breakdown. These adverse health effects drive~     increased cost as patients spend additional time in both the acute (hospital) and post-acute~     care settings. Physical activity is thus widely recognized as an important factor for~     improving outcomes in hospitalized patients; however, numerous challenges to its~     implementation exist. Specifically, although it has been found that with small increases in~     physical activity such as increasing number of steps by only 600 daily for inpatients,~     length of stay can be reduced by nearly 2 days, usual care in many hospitals, including the~     Cleveland Clinic, does not include exercise, and physicians do not all regularly order~     physical activity for their hospitalized patients. Even when activity is recommended or~     ordered, compliance and execution of the orders has been spotty and/or negligible. It is~     therefore clear that the current system for the provision of ambulation is ineffective. The~     investigators hypothesize that a graded protocol of ambulation which can be implemented by a~     dedicated patient care nursing assistant (PCNA) multiple times daily will provide~     significant benefit to patients without the labor and cost requirements of full-time nursing~     and physical therapy expertise. The objective of this study is to assess the feasibility and~     effectiveness of dedicated ambulator-assisted physical activity in elderly inpatients. The~     primary hypothesis is that an ambulator-assisted intervention for hospitalized elderly~     inpatients will prove feasible and may result in improved hospital outcomes, including less~     need for inpatient rehabilitation and shorter length of stay in the hospital. This study~     will provide pilot data for a larger randomized trial.~   "
22924|NCT02757118|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing cardiac surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and~     Group-HES (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes~     with cards will be conveyed to and kept in pharmacy department.~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will~     be determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
22925|NCT02757105|"~     This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After~     qualifying for the study and signing informed consent, patients will undergo a two-week~     observation period during which stool consistency and frequency data and symptom data will~     be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo.~     Patients will continue on treatment for 8 weeks. Each medication will be given once daily.~   "
22926|NCT02757092|"~     Pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the~     pulmonary complications after thoracic surgery. According to the literature reviews, these~     studies did not specifically point out the proper timing for the intervention of pulmonary~     rehabilitation on patients with thoracic surgery; moreover, interventions about pulmonary~     rehabilitation that focused on long-term training have not been studied. The purpose of this~     study is to determine whether Pulmonary rehabilitation are effective on patients who had~     thoracic surgeries.~   "
22927|NCT02757079|"~     The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep~     diaries and the safety of NPC-15.~   "
22928|NCT02757066|"~     The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d)~     versus placebo to sleep latency with electronic sleep diaries.~   "
22929|NCT02757053|"~     Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery~     (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post~     season on high school football players. One set of players will wear the Guardian Cap on~     their five star rated helmets and the other will wear five star rated helmets only. The~     investigators will compare outcomes of ImPACT scores and MRI findings between the two groups~     to see if there is a statistical difference in reduction of injury and to establish what the~     baseline level of MRI findings related to injury from high school football is as well as~     what the baseline level of injury is prior to the start of the season.~   "
22930|NCT02757040|"~     The purpose of this study is to determine whether the combination of As2O3 and ibrutinib is~     synergistic in chronic lymphocytic leukemia~   "
22961|NCT02756637|"~     The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs~     value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline~     NLR is correlated with overall survival after curative treatment for BC and 2) that baseline~     NLR is correlated with the survival benefit of NAC. The study will look at the data from~     participants of the SWOG 8710 study.~   "
22931|NCT02757027|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing CABG surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and~     Group-HES (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number).~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will~     be determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
22932|NCT02757014|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
22933|NCT02757001|"~     Spanish registry of retrievable vena cava filters.~      This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology~     (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive~     Techniques) of the University of Zaragoza (Spain).~      A software tool hosted on the official website of SERVEI and the journal Intervencionismo~     will be used for data collection a(https://estudios.watsoncme.com).~   "
22934|NCT02756988|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
22935|NCT02756975|"~     Prostate tissue biopsy is performed with either transrectal or transperineal approach. These~     two methods are usually based on tissue sampling with an ultrasound-guided core needle~     biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial~     technique or with a coaxial technique. In conventional transperineal technique, biopsy~     needle is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can~     be placed over the perineum; then, the direction of the biopsy can be changed by tilting the~     coaxial needle. In this prospective study, the investigators sought to compare the~     procedural time and the complication rate of coaxial technique with those of noncoaxial~     technique in transperineal prostate biopsy.~   "
22936|NCT02756962|"~     The investigators will prospectively determine whether the relapse-free and overall survival~     in patients who have cleared their leukemia-associated mutations treated with standard~     consolidation chemotherapy is superior to what is expected based on historical controls. The~     investigators will also prospectively determine the relapse-free and overall survival of~     patients who have not cleared their mutations. Because the relapse rate of patients with~     persistent mutations is expected to be high, treatment with either standard of care~     consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating~     physician.~   "
22937|NCT02756949|"~     This randomized controlled trial evaluates the provision of individual patient laboratory~     results to newly diagnosed HIV positive smartphone users through a secure application (app)~     as a method to get them linked to and retained in care, and engage with educational~     materials purposefully developed to explain their results. Message prompts will also be used~     to alert patients that their results are ready and provide information on how to link to~     care, and assistance to re-link to care if they fall out of the health system for any~     reason. Prompts will be sent to patients to remind health care workers if they are due for~     repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related~     laboratory test) at 6 months. The control group received standard of care.~   "
22938|NCT02756936|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm~     Pharmacuetical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,~     UK) in Healthy Human Volunteers Under Fasting Condition~   "
22939|NCT02756923|"~     Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor~     (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is~     to provide greater information on the mechanisms that effect stem spermatogonial maintenance~     renewal and proliferation in its relation to male infertility.~   "
22940|NCT02756910|"~     A new wireless axillary thermometer from Raiing Medical uses a proprietary system,~     iThermonitor (WT701), to provide better estimates of core temperature than a conventional~     axillary probe. Improvement results in part because the axillary probe measures and records~     temperatures continuously every 4 seconds and includes software to compensate for ambient~     temperature and positional changes including arm abduction.~      Whether the iThermonitor is sufficiently accurate for clinical use remains unknown. The~     investigators thus propose to evaluate the system in perioperative patients who often~     experience thermal perturbations over a range of several °C. Specifically, the investigators~     propose to determine the precision and accuracy of iThermonitor in surgical patients and~     during the initial hour of recovery. As in previous studies, the investigators will consider~     the thermometer sufficiently accurate for clinical use if most Raiing temperatures are~     within ±0.5°C of the reference temperature.~   "
22941|NCT02756897|"~     The goal of this clinical research study is to learn if venetoclax given in combination with~     ibrutinib can help to control CLL or SLL. The safety of the drug combination will be also~     studied.~   "
22959|NCT02756663|"~     The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at~     two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2~     i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in~     patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will~     be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due~     to disease progression or unacceptable toxicity or for other reasons.~      Patients who discontinue the study treatment for reasons other than documented disease~     progression will be followed for disease assessments every 8 weeks until progression. All~     patients will be followed for survival until 3 years have passed from their entry into the~     study, or they have discontinued the follow up earlier.~   "
22960|NCT02756650|"~     Primary objective of the study is to evaluate the safety and efficacy of canakinumab on the~     clinical and inflammatory findings of Behced Disease patients with neurologic and vascular~     involvement.~   "
22942|NCT02756884|"~     This is a single center, open label, prospective, randomized, controlled study in patients~     with non- revascularizable moderate or severe lower extremity Peripheral Arterial Disease~     (PAD) receiving autologous stem cells therapy (minimally manipulated). This study will~     enroll a maximum of 10 subjects in this study. The patients will be divided into two groups.~     One group will receive Adipose Derived Stem Cells (ADSCs) alone and the other group will~     receive low frequency ultrasound before the addition of ADSCs. The randomization will be~     1:1. If the results of this pilot study are not clearly different, there will be a need for~     a phase II study to support the results.~      Baseline, 6 week, 3 month and 6 month assessments of 6 min walking distance (6MWT), Ankle~     Brachial Indexes (ABIs)/Toe Brachial Indexes (TBIs), Transcutaneous Partial Oxygenation~     (TcPO2) and Rutherford assessments will be performed for the study group. Prior to the stem~     cell treatment, the ultrasound group patient will receive noninvasive transcutaneous pulsed~     focused ultrasound around the involved vessel(s) in the affected extremity. All patients~     will then receive 200 million autologous stromal vascular fraction cells containing adipose~     derived stem cell therapy: 1/3 of the cells will be delivered intra-venous proximal to the~     lesion (not retrograde), 1/3 of the cells will be delivered intra- adventitia proximal to~     the lesion and 1/3 of the cells will be delivered by intra- muscular injection along the~     vessel path (20-30 injections each separated by1.5 inch). Standard therapy for PAD patients~     will not be interrupted for the duration of the study. Standard therapy for PAD is defined~     as cardiovascular general measures like lifestyle changes, smoke cessation, exercise,~     cardiovascular rehabilitation, etc. All participants have already received maximal~     non-surgical therapy. Safety will be monitored on an ongoing basis.~   "
22943|NCT02756871|"~     The purpose of this study is to assess the effectiveness of CBT based online guided~     self-help intervention for perfectionism at reducing symptoms of perfectionism and Axis I~     disorders post-treatment and at six-month follow-up.~   "
22944|NCT02756858|"~     This open label extension study is designed to provide continued access to ANAVEX 2-73 for~     eligible subjects with mild to moderate Alzheimer's Disease who have previously participated~     in the Anavex sponsored study ANAVEX2-73-002.~   "
22945|NCT02756845|"~     This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec~     administration in pediatric subjects with advanced non-CNS tumors that are amenable to~     direct injection~   "
22946|NCT02756832|"~     The purpose of this study is to observe clinical response to treatment with alogliptin~     benzoate (Vipidia) utilization patterns in standard clinical practice.~   "
22947|NCT02756819|"~     The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil~     (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine~     clinical practice of hypertension (HTN) treatment in the Russian Federation and in the~     Republic of Kazakhstan..~   "
22948|NCT02756806|"~     Evaluate safety and efficacy with the enlighten laser for tattoo removal.~   "
22949|NCT02756793|"~     A multicenter randomized phase II trial of stereotactic body radiotherapy for~     oligo-progressive non-small cell lung cancer. Eligible patients will be randomized in a 1:2~     ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy~     (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon~     as possible following randomization, and subjects will be followed until next disease~     progression. The primary outcome is progression-free survival (PFS).~   "
22950|NCT02756780|"~     'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to~     provide social support and improve mental wellbeing amongst those affected by cancer,~     whether patients, carers or staff. Research has already demonstrated that these choirs can~     reduce depression and anxiety amongst participants and improve social support networks and~     quality of life as well as preliminary evidence that they can reduce levels of stress~     hormones and improve immune function. The aim of this study is to establish more about the~     psychological benefits of regular choir singing and explore whether the biological changes~     noted in pilot studies can be sustained over time. This could identify whether choirs have~     the potential to optimise health in people affected by cancer, helping to put patients in~     the best position to receive treatment or maintain remission and supporting those who care~     for someone with cancer, whether professionally or informally.~   "
22951|NCT02756767|"~     The goals of this study are to assess the feasibility of weekly administration of site~     specific patient reported assessments using an electronic platform and to explore the~     correlation between patient reported outcomes as well as known dosimetric prognostic factors~     in patients with lung, breast, head and neck, or pelvic malignancies~   "
22952|NCT02756754|"~     The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a~     prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma~     concerning the efficacy on blood pressure control. The safety of the procedure is one of the~     secondary outcomes.~   "
22953|NCT02756741|"~     The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a~     third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on~     day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high~     price of albumin. In the current randomized control trial investigators compared the effect~     of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose~     (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid~     and blood.~   "
22954|NCT02756728|"~     The purpose of this study is to investigate the safety and efficacy of administering BI-505~     in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma~     patients.~   "
22955|NCT02756715|"~     Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx~     of blood flow. syndecan-1 was a marker of glycocalyx.~      The purpose of this study is to prove the variation of level of serum syndecan-1 between~     preoperative and postoperative period.~   "
22956|NCT02756702|"~     Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing~     surveillance plan for the product under investigation For this PMCF only CE-marked medical~     devices will be used within their intended purpose and no additional invasive or other~     stressful examinations are to be carried out (acc. to MPG §23b).~   "
22957|NCT02756689|"~     The investigators are performing a randomized controlled-trial investigating starting~     cervical ripening in the outpatient setting with a mechanical method, the transcervical~     Foley catheter. This is a pilot study to establish the efficacy of this method in decreasing~     time as in inpatient and evaluate patient satisfaction.~   "
22958|NCT02756676|"~     This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative~     program on quality of life in patients with Parkinson's Disease.~   "
22962|NCT02756624|"~     This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution~   "
22963|NCT02756611|"~     The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax~     monotherapy in approximately 250 participants with relapsed/refractory CLL including those~     with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received~     prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg~     once daily. The dose must be gradually increased over a period of 5 weeks up to the daily~     dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the~     treatment period, participants may continue on into a 2-year follow-up period.~   "
22964|NCT02756598|"~     Patients scheduled for elective cardiac surgery are preoperative evaluated using different~     personality type, stress and anxiety tests.~      Patient are randomized to receive the investigators' standard moderate dose sufentanil~     (bolus 1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5~     microgram/kg and propofol 0.06 mg/kg/min).~   "
22965|NCT02756585|"~     Traumatic brain injury (TBI) is a leading cause of post-injury hospitalization, disability,~     and death worldwide. In Nova Scotia, approximately 50% of major trauma reported is head~     trauma. TBI is predicted to be the most common and expensive neurological condition in~     Canada through the year 2031.~      Families and medical teams must often decide on the appropriate level of care for patients~     with severe TBI and frequently need to consider withdrawal of life support measures. These~     decisions have implications for patients with severe TBI, costs to the health care system,~     and rates of organ donation.~      A reliable method for neurological evaluation at the time of the patient's arrival to the~     hospital is important, because it is possible that many patients with severe TBI already~     have permanent brain damage. Assessing this brain damage with clinical tests is difficult~     because of the nature of patients' injuries and the sedative medication they receive at the~     time of their hospital admission. Current standard imaging technique for these patients is~     severely limited in the assessment of the extent and severity of the brain damage.~      Advanced diagnostic imaging, called Computed Tomography Perfusion (CTP), can help detect~     permanent brain damage. However, CTP of the head is not currently done for patients with~     severe TBI when they arrive at the hospital. The investigators want to test whether CTP of~     the head can detect permanent brain damage among patients with severe TBI.~   "
22966|NCT02756572|"~     This clinical trial studies how well early stem cell transplantation works in treating~     patients with high-grade myelodysplastic syndrome or acute myeloid leukemia that has come~     back after a period of improvement or does not respond to treatment. Drugs used in~     chemotherapy, such as filgrastim, cladribine, cytarabine and mitoxantrone hydrochloride,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before~     a donor peripheral blood cell transplant helps stop the growth of cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may~     also replace the patient's immune cells and help destroy any remaining cancer cells. Early~     stem cell transplantation may result in more successful treatment for patients with~     myelodysplastic syndrome or acute myeloid leukemia.~   "
22967|NCT02756559|"~     Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process~     of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction.~     Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have~     showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in~     sepsis. The present research further study the regulatory mechanism of those miRNAs in~     lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a,~     miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in~     regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new~     targets for sepsis treatment.~   "
22968|NCT02756546|"~     This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in~     plasma of SLE patients and difference in their expression among groups with different~     systemic lupus erythematosis disease activity index (SLEDAI) scores.~   "
22969|NCT02756533|"~     COPD is characterized by non-reversible chronic airway obstruction. Its evolution is~     punctuated by successive exacerbations precipitating the progression of the disease and its~     co-morbidities. The most severe exacerbations are the source of frequent hospitalizations~     that strongly affect the patient's quality of life and are associated with increased~     mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult~     their doctor too late which may lead to delays in care. However, the early detection and~     management of these exacerbations can reduce their impact and in particular avoid~     hospitalization or shorten their duration.~      In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in~     COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The~     investigators have demonstrated in a previous study that the analysis of parameters from~     software embedded in the NIV device can reliably predict the occurrence of an exacerbation.~     The investigators hypothesize that the daily transmission via a telemonitoring platform of~     the ventilation parameters of patients, together with an ad hoc warning system, would reduce~     the rate of hospitalization for COPD patients treated at home with NIV thanks to the early~     detection and early treatment of these exacerbations.~      The purpose of the study is to compare if a program of telemonitoring using the parameters~     stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory~     symptoms in COPD patients versus standard care over a one year period.~   "
22970|NCT02756520|"~     The purpose of this study is to characterize the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
23040|NCT02755597|"~     This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study~     evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in~     subjects with relapsed or refractory multiple myeloma who are considered sensitive or naïve~     to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.~   "
22971|NCT02756507|"~     Anxiety and depressive disorders are common in children and adolescents, however they are~     often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive~     behavioral therapy (CBT) is efficient for children and adolescents. School settings are~     appropriate environments to deliver such interventions for vulnerable youths. Given youth's~     access and predilection to use technology, a technology-enhanced prevention program was~     developed. The present study aims to investigate the efficacy of a transdiagnosticREBT~     prevention program for internalizing symptoms in children and adolescents, implemented in a~     school setting.~      Classes from different Romanian public schools will be randomized in either intervention or~     wait list group. The prevention program will be group-based, delivered in 6 sessions, over 3~     weeks. Participants would be assessed baseline and post-intervention. Each of the six~     modules aimed a different component: Psychoeducation, Relaxation and Breathing, Relationship~     between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring,~     Exposure, Maintenance of gaining. Despite specific activities, for each session a cartoon on~     that subject will be viewed and discussed. Homework would be given at every session.~      REBT/CBT prevention programs delivered in school settings represent ecological modalities to~     target vulnerable groups. Technology components added to traditional programs may lead to~     greater motivation and satisfaction with treatment.~   "
22972|NCT02756494|"~     Stroke is the fifth leading cause of death in the United States and the leading cause of~     disability. However, in China, stroke is one of the most frequent causes of death and~     chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as~     a relatively uncommon event in the proportion of <5% of all ischemic strokes.~   "
22973|NCT02756481|"~     To characterize treatment patterns and healthcare resource utilization among adults~     diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in~     Venezuela.~   "
22974|NCT02756468|"~     Background. Pancreatic cancer surgery is associated with very high risk of postoperative~     morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated~     with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to~     monitor bacterial infections and guide antibiotic therapy and has been shown to have better~     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white~     blood cell count (WBC).~      Purpose. The investigators designed a monocentric pilot study to test if PCT might be a~     sensitive and reliable marker of AL after pancreatic surgery~   "
22975|NCT02756455|"~     Background. Gastric cancer surgery is associated with high risk for postoperative morbidity~     and mortality. Anastomotic leak (AL) is one of the worst complications associated with~     relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor~     bacterial infections and guide antibiotic therapy and has been shown to have better~     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white~     blood cell count (WBC).~      Purpose. Investigators designed a monocentric pilot study to test if PCT might be a~     sensitive and reliable marker of AL after gastric surgery~   "
22976|NCT02756442|"~     Introduction:~      The pregnancy brings about physiological and hormonal modifications which cause sleep~     disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the~     pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The~     limited airflow causes micro-awakenings that enter in the frame of the high resistances~     airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings~     at pregnant women.~      Objectives:~      To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman~     with or without gestational diabetes~      Methods :~      It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who~     consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going~     to compare the breathing disorder during sleep of a control group with a group of women with~     gestational diabetes. A polysomnograph will be run at the included patients' home.~      Expected results :~      The physiological and hormonal modifications during the pregnancy could favor nocturnal~     sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational~     diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that~     limited airflow in association with micro-awakenings in the RERA have a negative impact on~     the glucose metabolism and favor the gestational diabetes.~   "
22977|NCT02756429|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact~     on the general morbidity and risk of stroke, AF is a great concern for public health.~     Several mechanisms, including endothelial dysfunction and inflammatory processes, have been~     postulated as predisposing factors for AF, as well as for stroke.~      Both clinical and experimental studies highlight inflammation as a predisposing factor for~     AF and its complications. Nevertheless, the source of high inflammatory proteins in patients~     with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac~     (left femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several~     inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation~     in AF patients.~      The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also~     help to define the site of endothelial dysfunction and of production of this thrombogenic~     factor.~      Although AF is associated with an increased risk of stroke, the risk is not homogeneous.~     Permanent and persistent AF are associated with similar thromboembolic risk to that of~     paroxysmal AF.~   "
22978|NCT02756416|"~     This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm~     reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these~     data at multiple time points during RCVS progression, the investigators will assess the~     relationship between vasoconstriction and downstream perfusion and determine the role of~     these imaging techniques in early and accurate diagnosis of RCVS. The investigators also aim~     to investigate whether early imaging abnormalities can predict RCVS complications and~     clinical outcomes.~   "
22992|NCT02756221|"~     The study will evaluate the change in gastrointestinal (GI) flora following probiotic~     supplementation, and expected to lead to an increase in the intestinal epithelial integrity~     and to improvement in its health. Concurrently with the reduction in the amount of toxins in~     the GI tract following an intensive exercise, a lower incidence of symptoms of discomfort~     will improve the quality of the training sessions which will be exhibited by an improvement~     in endurance capacity and in physiological responses to rigorous exercise. Half of the~     participants will receive probiotic supplement while the other half will receive a placebo.~   "
22979|NCT02756403|"~     This study, a double blinded randomized controlled trial, is being done to compare side~     effects of commonly used antibiotic regimens prior to same day abortion procedures.~      In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks~     gestation) will be randomized to receive one of the three commonly used antibiotics~     (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior~     to their abortion procedure. Approximately, 30-60 mins after study drug administration, the~     procedure will be performed.~      A sub-study will be completed on 40 women who consent to endometrial sampling and to have~     their blood drawn.~   "
22980|NCT02756390|"~     This research study is evaluating the effectiveness of a 3-session behavioral intervention~     for insomnia in cancer survivors. This is a behavioral intervention study, and no~     medications are involved.~   "
22981|NCT02756377|"~     Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with~     gingivitis as compared to non-alcoholic chlorhexidine mouth wash.~      Methods & Material: Twenty-four subjects, without systemic diseases, with plaque-induced~     gingivitis will be selected for this study. The patients were treated with scaling and root~     planing at the baseline; Oral hygiene instructions were given that included brushing twice-~     daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2~     minutes, these patients were randomly ,equally divided into two groups, Group A: perform~     daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium,~     (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day~     with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each~     phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of~     each volunteer were measured.~   "
22982|NCT02756364|"~     The primary purpose of this study is to compare the progression free survival (PFS) of~     participants treated with the combination of fulvestrant plus daily MLN0128 and fulvestrant~     plus weekly MLN0128 versus participants treated with single-agent fulvestrant.~   "
22983|NCT02756351|"~     The study is a first step in establishing the safety and efficacy of the CytaCoat technology~     when applied to a medical device such as a nasal prong and the clinical data generated will~     serve as a basis for continuous studies in clinically significant settings such as the~     neonatal care units.~   "
22984|NCT02756338|"~     The purpose of this study is to evaluate the safety and feasibility of performing the~     BioMonitor 2 insertion procedure in an office setting.~   "
22985|NCT02756325|"~     Infertility-the inability to conceive despite one year of properly timed unprotected~     intercourse-is a common problem. Of all types of male factor infertility, non-obstructive~     azoospermia may be the most difficult for couples. Importantly, patients with~     non-obstructive azoospermia are asked to make difficult decisions in terms of reproductive~     choice; surgical attempts at identifying sperm (microdissection testicular sperm extraction)~     are often offered to these patients without a guarantee of being able to identify sperm. New~     methodologies in terms of evaluation of azoospermic males PRIOR to the couple embarking upon~     IVF are needed urgently. The other potential benefit of non-invasive determination of testis~     function and spermatogenesis would be the potential targeting of sperm extraction~     procedures. We hypothesize that quantitative MRI employing advanced functional metrics will~     be sensitive to functional and metabolic differences between subsets of azoospermic cases~     and will improve upon current characterization of patients with this condition. Moreover, it~     is believed that these techniques will provide complementary information, such that they may~     be combined in a synergistic fashion for targeted extraction methodologies.~   "
22986|NCT02756312|"~     Although bench data and retrospective studies have provided a promising picture of the~     possible influence of anesthetic technique on the risk of tumor recurrence, current evidence~     from RCTs is inadequate to show whether the type of anesthetics might influence tumor~     recurrence.There are many thousands of patients with a cancer diagnosis undergoing surgery~     every year, and in the context of biological plausibility, it should lead to the urgent~     undertaking of prospective research to further evaluate the association between the~     anesthetic management and postoperative malignant glioma recurrence.~   "
22987|NCT02756299|"~     Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive~     airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive~     events, reduces daytime sleepiness, and improves quality of life, especially in those with~     excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall~     acceptance and adherence rates are not fully promising. Less is known regarding the PAP~     adherence rates in Turkey. In the current study, the researchers primarily addressed if an~     intensified patient education strategy including the polysomnography (PSG) charts viewing~     followed by frequent follow-ups would improve the compliance rates at long-term in patients~     with OSA.~   "
22988|NCT02756286|"~     The purpose of this study is to refine a new assessment tool for Attention~     Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to~     discriminate between individuals with ADHD and healthy controls.~   "
22989|NCT02756273|"~     During the creation of an ileostomy, a bridge device is systematically placed in an aim to~     reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported~     to justify this issue.~      Moreover the placement of a bridge device increases the difficulty of nurse cares and is~     associated with its own morbidity.~   "
22990|NCT02756247|"~     The purpose of this study is to find out if the combination of buparlisib and ibrutinib will~     lead to better treatment results in patients with relapsed or refractory Follicular~     lymphoma, (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The~     investigators are using buparlisib and ibrutinib because both drugs seem to block different~     proteins that allow cancer cells to keep growing. Blocking these proteins may help by making~     the cancer cells undergo cell death, which will stop uncontrolled tumor growth.~   "
22991|NCT02756234|"~     The objective of this study is to carefully monitor all patients undergoing Computed~     Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the~     efficiency of the CTP procedure in a community setting.~   "
22993|NCT02756208|"~     This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized,~     placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult~     volunteers (Human Immunodeficiency Virus-1 uninfected).~   "
22994|NCT02756195|"~     The study objective is to decrease neonatal mortality and morbidity by elucidating the~     etiology of system failures during perioperative care.~      In Aim 1 the investigators will use a novel event discovery method, based on the construct~     of the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem~     attributes and potentially dangerous conditions. A NRE is defined as any event that is~     perceived by care providers or skilled observers as a deviation from optimal care based on~     the clinical situation.~      In Aim 2, the investigators will perform a comparative analysis of prospectively collected~     NRE data to the data collected by conventional event reporting methodologies.~      In Aim 3 the investigators will collaborate with the Tennessee Initiative for Perinatal~     Quality Care (TIPQC) to conduct practical pilot testing of tools and measures developed and~     refined in the first two Aims.~      Products from Aims 1 & 2 will include:~        1. a taxonomy of NREs and outcomes for perioperative neonates;~        2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection~          tool;~        3. comparisons of 5 established event reporting systems, including their rates, costs and~          benefits; and~        4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and~          NICUs.~      Aim 3 will capitalize on TIPQC's robust network of NICUs, neonatologists, and patient-level~     outcome data to conduct a pilot implementation evaluation of the methods and tools developed~     and refined in Aims 1-2.~   "
22995|NCT02756182|"~     A comparative study will be conducted and the patient will undergo a conventional urodynamic~     study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP)~     measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal~     pressure (Pabd) will be collected concurrently in the sitting position and at various fill~     volumes for the bladder.~   "
22996|NCT02756169|"~     Investigators propose this study in order to answer the following research question: An~     educational intervention and breastfeeding support at postpartum will increase the frequency~     and total breastfeeding duration in the intervention group? This is a randomized (with~     control and intervention groups) study, open and parallel (1: 1 ratio between study groups)~     with 200 pregnant women in the second or third trimester, according to their body mass index~     (BMI, kg / m2) with excess weight (BMI> 29 pre-pregnancy weight) and that will address their~     pregnancy in the public health services and hospitals belonging to the Health Ministry of 5~     districts: Coyoacán, Magdalena Contreras, Tlalpan, Xochimilco and Alvaro Obregón in Mexico~     City.~      The intervention group and the control group will have the same characteristics for~     eligibility.~      The main phases to develop the study are PHASE 1. INTERVENTION DESIGN PHASE 2.~     IMPLEMENTATION OF THE INTERVENTION. PHASE 3. FOLLOW-UP The intervention will be offered at 3~     times: 1) Educational intervention (a workshop) to pregnant obese women. The workshop will~     be held by an International Board Certified Lactation Consultant (IBCLC) to promote~     exclusive breastfeeding and to encourage a better breastfeeding performance in accordance~     with the WHO recommendations. The workshop will be held at convenient times and will be~     conducted for groups of 8 to 10 participants; 2) Immediate breastfeeding support at hospital~     by an IBCLC and; 3) The women will be exposed to early telephonic follow-up during the first~     week of their children´s life and each month until six months of life. Then, if the~     breastfeeding continues, each two months until the first year of their children´s life.~      At the first month postpartum, investigators will visit participants at home, both the~     control group and the intervention group, for collecting information on breastfeeding~     practices, for taking a breast milk sample to estimate its fatty acids content, and a blood~     sample (serum) to obtain the C-Reactive Protein. Also, the investigators will take~     anthropometric measurements of the children to evaluate their growth (weight, length, and~     skinfold thickness). Investigators will ask for breastfeeding practices and diet of the~     participants through a 24 hours recall.~      The results of this intervention group will be compared with the control group: pregnant~     obese women without the educational intervention or telephonic follow-up.~   "
22997|NCT02756156|"~     Combining interscalene block with infraclavicular block for humerus surgery provides a~     unique surgical anaesthesia and postoperative analgesia.~   "
22998|NCT02756143|"~     Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.~   "
22999|NCT02756130|"~     This clinical trial is a Phase II, single center, open label, proof-of-concept study~     evaluating the efficacy of birinapant in combination with platinum based chemotherapy. This~     pilot study is aimed at determining the efficacy of carboplatin and birinapant co-therapy in~     treating patients with advanced newly diagnosed or recurrent high grade serous carcinomas.~     Only bio-assay positive patients will be enrolled~   "
23000|NCT02756117|"~     This study aims to assess the effect and breakdown of lysine administration, specifically~     examining whether it leads to increased plasma 2-AAA in healthy humans.~   "
23001|NCT02756104|"~     ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is~     3 years after onset, but may vary from a few months to more than 30 years. Various factors~     have been suspected to play a role in such a variation, but recently, it has been described~     that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D~     is an hormone know to regulated T reg function in vivo and in vitro. It have recently~     demonstrated that vitamin D (VD) levels correlated with ALS prognosis. The investigator want~     to go further in the study of the immune processes that could modulate prognosis in ALS.~     This could allow proposing VD as a potential treatment of ALS in a future trial. More~     largely, this could reinforce arguments in favor of an immune intervention to attenuate the~     severity of this devastating disorder.~   "
23002|NCT02756091|"~     Cervicocerebral artery dissection is a major cause for stroke in young adults. While~     knowledge of cervical artery dissection (CeAD) has increased thanks to a number of high~     quality studies, knowledge on intracranial artery dissection (IAD) is limited. Due to~     treatment and publication bias little is known about the natural history of IAD. Overall,~     IAD is assumed to have a more severe course than CeAD, with a more ominous outcome in~     patients with subarachnoid hemorrhage (SAH). Furthermore, little information is available on~     the risk of recurrent IAD as well as on the risk of recurrent ischemic and haemorrhagic~     events in non-Asian patients. Radiological diagnosis of IAD can be challenging given the~     small size of intracranial arteries, and the subtle and non-specific radiological signs~     which tend to evolve over time. The optimal treatment of IAD is unknown. There are no~     randomised trials and only observational studies with relatively small sample sizes are~     available, thus providing a very low level of evidence.~      Finding the factors that are decisive for outcome and recurrence after intracranial artery~     dissection is key to an improved management of this potentially severe disease predominantly~     affecting young patients. By using standardised protocols for diagnosis, imaging and~     follow-up, the investigators intend to obtain large representative patient samples in order~     to fill the gap of evidence.~   "
23003|NCT02756078|"~     This is a randomized, double-masked dispensing study where subjects will randomized into one~     of two lens sequences to wear each of two contact lens types for a 4-week period with each~     lens type.~   "
23004|NCT02756065|"~     Washington University Early Recognition Center is conducting a research study to examine~     brain functional connectivity and network patterns in participants with bipolar disorder and~     schizophrenia.~   "
23005|NCT02756052|"~     Recent changes in medical training environments and restrictive work-hour regulations have~     greatly impacted trainees, limiting the number of opportunities to gain proficiency in~     procedural skills. Reports suggest that medical residents lack confidence in their ability~     to perform certain medical procedures, and program directors often do not believe their~     residents can operate independently in major procedures. Simulator based task training~     (SBTT) has provided a safe and ethically appropriate method of skill acquisition but~     training opportunities remain limited. Methods to enhance motor learning during these~     training opportunities have not been described. Transcranial direct-current stimulation~     (tDCS) is an emerging form of non-invasive brain stimulation that has been shown to improve~     motor learning. tDCS has been shown to enhance increasingly complex skill acquisition. The~     investigators propose to examine if tDCS can improve the acquisition and retention of~     laparoscopic surgical skill. The investigators propose a double blind, sham-controlled~     randomized trial applying tDCS during evidence-based SBTT of medical students and surgical~     residents, to determine if brain stimulation can enhance training effects and long-term~     skill acquisition. Even a modest enhancement carries the potential to transform~     medicosurgical skills training.~   "
23006|NCT02756039|"~     Clinical experience investigation (CEI) is to be conducted to confirm the following to~     characterise safety and efficacy of Tagrisso Tablets in actual clinical use.~        1. Incidence of adverse drug reactions (ADRs) in actual clinical use~        2. Factors which may affect safety and efficacy of the product (especially analysis of the~          incidence and risk factors of interstitial lung disease (ILD) events)~        3. Information of ADRs not expected from Precautions for Use of the package insert in~          Japan~   "
23007|NCT02756026|"~     The purpose of the study is to establish a protocol for collecting representative samples of~     breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN)~     supplementation on milk MN concentrations. The investigators will determine which~     breastfeeding episode during the 24 hour period best represents the maternal status; and~     within the episode whether fore, mid or hind milk samples be collected in future studies.~   "
23008|NCT02756013|"~     The purpose of this study is to evaluate the side effects and effectiveness of giving~     standard paclitaxel chemotherapy in doses based on actual body surface area in combination~     with standard dosed carboplatin chemotherapy for overweight women.~   "
23009|NCT02756000|"~     The study will compare clinical outcomes between complete revascularization during~     hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30~     days and intervention based on outpatient non-invasive ischemia testing in patients with~     multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial~     infarction.~   "
23010|NCT02755987|"~     This is an expanded access study with ANG1005 treatment for two individual patients from~     Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III~     Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with~     Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.~   "
23011|NCT02755974|"~     The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995~     and designed to study COPD exacerbations and their impact on health-status and disease~     progression.~   "
23012|NCT02755961|"~     Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And~     most phosphate in human is derived from the food. The purpose of this study is to evaluate~     the efficacy of nutritional consultation and education on phosphate binder among dialysis~     patients.~   "
23013|NCT02755948|"~     Respiratory viruses including influenza and respiratory syncytial virus (RSV) are among the~     most important causes of severe disease globally, infecting everyone repeatedly throughout~     life. Understanding of how to prevent infection is incomplete but boosting immunity with~     vaccines remains the best strategy. T cells have been shown in animals to be essential for~     clearing respiratory viral infection and are likely to be helpful if stimulated by vaccines.~     However, where these cells originate from and how they develop in the human lung are still~     unclear. The investigators will inoculate volunteers with influenza or RSV to examine the~     relationship between T cells in their blood and lungs and the outcome of infection. By~     tracking these specialised cells, the investigators aim to develop a better understanding of~     how they are generated in order to harness them with future vaccines.~   "
23014|NCT02755935|"~     To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532~     electrode array.~   "
23015|NCT02755922|"~     Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal~     stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft~     treatment, improving bone neoformation.The objective was to evaluate the effectiveness of~     AMSCs application in mandibular fractures to reduce regeneration time and increase bone~     quality.~   "
23016|NCT02755909|"~     The study aims to investigate the effect of pre-anesthetic education on patients undergoing~     cardiac surgery~   "
23017|NCT02755896|"~     Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600~     centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given~     every other day (arm 2). Patients will complete treatment in one week. All patients will be~     followed a month after the completion of treatment then q6 months for the first year, then~     yearly for the next 10 years.~   "
23018|NCT02755883|"~     This randomized controlled trial will evaluate, among 54 stage early stage lung cancer~     patients, whether a behavioral intervention versus an educational Control group results in~     improved function at 6-months.~   "
23019|NCT02755870|"~     This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind,~     escalating single- and multiple-dose study to evaluate the safety, tolerability, and~     pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to~     this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase.~     The SAD Phase will be conducted first followed by the MAD phase of the study.~   "
23020|NCT02755857|"~     This open-labelled, single arm study is a follow-on from Study MPG010 to compare the~     relative bioavailability of Lozanoc 65 mg Capsules against Lozanoc 50 mg Capsules and~     Sporanox 100 mg Capsules in patients requiring itraconazole anti-fungal prophylaxis.~   "
31253|NCT02648022|"~     To determine the effect of an integrated care protocol on antiviral treatment and sustained~     virologic response (SVR) rates following initiation of direct acting antiviral therapies~     (DAA) treatments in 2011.~   "
23021|NCT02755844|"~     Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025~     deaths/ year). The 5-year overall survivals of patients at diagnosis with locally advanced~     and metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment~     with platinum-based chemotherapy, there is lack of effective drug in this disease, which~     explains the poor prognosis of patients.~      The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been~     shown to be effective beyond first chemotherapy line.~      Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and~     of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase~     (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition~     of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.~      Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib~     because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable~     toxicity profile.~      Metformin may increase the anti-proliferative effects of olaparib because it downregulates~     IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.~   "
23022|NCT02755831|"~     Prospective, randomized controlled trial. Pregnant women in early pregnancy will be~     randomized to either the Sleep Study + CPAP group (n = 180) or to a Standard Prenatal Care~     group (n = 180). Subjects in the Sleep Study + CPAP group will complete a sleep study~     (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the AHI ≥5 as indicated, in~     early and late pregnancy, whereas the other group will receive standard prenatal care. All~     subjects will complete a sleep study again at 12 weeks postpartum.~   "
23023|NCT02755818|"~     Approximately 20 million people in the United States have some form of kidney failure.~     People with kidney failure have an increased chance of having low levels of high density~     lipid (HDL), so called good cholesterol. Patients who are overweight or obese also have~     low levels of HDL. The investigators are trying to find out whether causes of low HDL are~     the same in people who are overweight and in patients with kidney failure so that in the~     future doctors can better treat low HDL cholesterol levels. People with low levels of HDL~     are more likely to have heart attacks and strokes and are more likely to lose kidney~     function. This study hope to learn more about how kidney failure causes low HDL cholesterol~     levels.~   "
23024|NCT02755805|"~     Cognitive impairments occur frequently after stroke, and are associated with significant~     long-term activities of daily living (ADL) disability and poor quality of life. This~     research study will undertake an innovative approach addressing cognitive impairments, by~     examining a new patient-centered functionally-relevant rehabilitation intervention that~     teaches individuals with cognitive impairments to manage their deficits to reduce ADL~     disability.~   "
23025|NCT02755792|"~     This study is aimed to investigate the efficacy of an 12-week Chinese calligraphy training~     program for enhancing cognitive and emotional functions of older adults with mild cognitive~     impairment. Participants are tested with several cognitive tests and electroencephalography~     (EEG), psycho-physical parameters and brain activities are recorded. Results are compared at~     pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of~     benefits of Chinese calligraphy practice.~   "
23026|NCT02755779|"~     Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is~     common to discover Incidental breast lesions on chest CT.~      The goal of this study is to investigate the incidence and appearance of incidentally~     discovered breast masses on chest CT.~   "
23027|NCT02755766|"~     While studies have shown that better outcomes are associated with brace wear compliance in~     the scoliosis and clubfoot populations, compliance rates are still poor. Reasons identified~     by patients, parents and research for not complying with prescribed brace wear include the~     inconvenience or irritability of the child when in the brace in the case of clubfeet, and~     fear of looking different from peers, clothes not fitting properly, or discomfort in the~     case of scoliosis. While reasons for noncompliance are many and can be complex, there has~     been some research to indicate that personality traits may play a role in brace wear~     compliance.~      The primary purpose of the proposed study is to determine if personality traits are related~     to compliance patterns for individuals undergoing brace treatment for AIS or Clubfeet.~   "
23028|NCT02755753|"~     The purpose of this study is to evaluate whether Rebamipide facilitate the healing of~     inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).~   "
23029|NCT02755740|"~     This project aims to promote quitting, and reduction for those who do not want to quit,~     among female smokers through training female youth as smoking cessation and reduction~     ambassadors (SCRA). The objectives are to:~        1. Promote age and gender-specific smoking cessation and reduction to the female~          population~        2. Deliver a smoking cessation and reduction ambassador training workshop to equip and~          empower female youth with the knowledge on the adverse effects of smoking on female~          smokers and the skills in smoking cessation and reduction and in raising public~          awareness of the harmful effects of smoking on female smokers.~        3. Have the trained female youth to deliver a brief advice (AWARD) to female smokers to~          help them to quit or reduce smoking and refer them to the female-specific smoking~          cessation hotline or the Department of Health Quitline for further assistance if~          needed.~   "
23030|NCT02755727|"~     Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with~     repetitive use of the forearm extensor muscles. Though often self-limiting in nature there~     are a proportion of patients who fail to respond to conservative treatments such as rest,~     activity modification, physiotherapy and the use of a brace. Though previously a common~     treatment modality steroid injections have been shown to be detrimental in the longer term.~     Present practice is to offer those patients who do not respond to conservative treatment~     surgical debridement. Though often effective this is an invasive procedure. Platelet rich~     plasma injections may offer a viable alternative in chronic cases however there is no~     systematic evidence of its efficacy.~      Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be~     randomly assigned to receive either open surgical debridement or platelet rich plasma~     injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6~     and 12 months. The outcome of each treatment will be assessed using validated outcome~     scoring measures specifically designed for upper limb pathology. The results of this pilot~     study will be used to construct a larger randomised control trial.~   "
23031|NCT02755714|"~     Exercise Induced Laryngeal Obstruction (EILO) is a condition not uncommon in otherwise~     healthy young people. EILO is caused by posteromedial collapse of supraglottic structures or~     medialization of the vocal folds, or both, during high intensity exercise. There are~     currently no treatments available that is properly evidence based. However, case reports~     suggest a possible effect from the asthma drug Ipratropium Bromide (Atrovent®). The~     current project is an open label pilot study, aiming to test if Atrovent can influence the~     occurence of EILO, either postponing the onset during exercise or fully prevent the~     condition to occur.~   "
23032|NCT02755701|"~     To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic~     patients with ascites.~   "
23033|NCT02755688|"~     Atrial fibrillation (AF) is the most common heart arrhythmia. Many people do not have~     symptoms and are not aware they have AF. Others may feel dizzy, short of breath, feel very~     tired and become aware of a fast and irregular heart beat (palpitations). The main~     complication of AF is an increased risk of stroke and incidence of heart failure. There are~     two key aspects of treatment for AF. The first is protection from stroke, treated with oral~     anticoagulants. Treatment of AF is either by controlling the rate (frequency of contraction)~     or controlling the rhythm (restoring regular contraction). Rate-control is generally~     employed first with an intent to reduce the rate at which the lower pumping chambers~     contract and improve their efficiency. Appropriate medication is used and with this~     treatment strategy it is accepted that AF will be present as the long term heart rhythm. If~     symptoms persist despite medication the preferred strategy is to restore sinus rhythm (SR)~     and regular contraction in all pumping chambers of the heart. This can be done with electric~     shock treatment (DC cardioversion) together with long-term tablet medication, or by a more~     definitive 'cauterisation' therapy (catheter or thoracoscopic surgical ablation). In this~     study the investigators will study patients with symptomatic long standing persistent AF~     (continuous AF for more than 1 year) who have tried and failed drug and/or electrical~     therapy. At present the investigators do not know what the best ablation technique is for~     treating symptomatic, long-standing persistent AF (LSPAF). Catheter ablation (CA) is the~     most widely available invasive treatment available for AF. Thorocoscopic surgical ablation~     (SA) is not widely available but our hospitals have the expertise to conduct this procedure.~     CA has been shown to achieve modest degrees of success in restoring normal SR with the~     caveat that most patients do require 'multiple' procedures (usually two or three). SA offers~     patients an alternative choice of therapy with a keyhole surgical thoracoscopic) approach.~     It may have a higher single procedure success rate although there is the potential for~     greater complication rates. The investigators aim to examine this in detail to help us~     understand which approach might be better for managing LSPAF.~   "
23034|NCT02755675|"~     uPAR PET/CT as a prognostic marker in non-small cell lung cancer.~   "
23035|NCT02755662|"~     ESTAMPS is a randomized clinical trial with a crossover design:~      Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs~     (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway~     volume~      secondary objectives: To evaluate the maximal mandibular propulsion according to the type of~     MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact~     of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on~     mandibular positioning~   "
23036|NCT02755649|"~     The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab~     compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult~     patients with severe AD who are not adequately controlled with, or are intolerant to, oral~     Cyclosporine A (CSA), or when this treatment is currently not medically advisable.~      The secondary objective is to assess the safety and tolerability of 2 dose regimens of~     dupilumab compared to placebo, administered with concomitant TCS, in adult patients with~     severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when~     this treatment is currently not medically advisable.~   "
23037|NCT02755636|"~     Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and~     premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile~     tools designed to assist patients and primary care providers (PCPs) in applying~     evidence-based principles of health behavior change to reduce four cancer risk~     behaviors—cigarette smoking, risky drinking, noncompliance with national guidelines for~     physical activity, and overweight and obesity—and depression among at-risk patients. The~     intervention is based on the Transtheoretical Model of Behavior Change (TTM, the stage~     model) and includes computer-tailored interventions and text messages for patients and a~     clinical dashboard for providers. The efficacy of the intervention will be assessed in a~     cluster-randomized trial involving 780 patients recruited from 12 federally qualified health~     centers randomly assigned to intervention or usual care.~   "
23038|NCT02755623|"~     The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool~     for improving schizophrenic symptoms, in particular resistant hallucinations, has been~     increasingly studied over the past decades. Several studies have demonstrated that~     low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal~     Junction (TPJ), which are known to decrease local activity, significantly reduced auditory~     verbal hallucinations in schizophrenic patients. In spite of highly promising results, a~     high level of inter-individual variability in the responses to non-invasive brain~     stimulation treatments, and the fact that rTMS may prove ineffective in some patients, keep~     spurring controversy about the efficacy of these approaches (as currently performed), as~     well as about how to increase its efficacy and consistency. Accordingly, the objectives of~     this project are to better understand the impact of rTMS on the brains of patients with~     resistant auditory hallucinations, and to use this information not only to better understand~     this condition but to develop more efficient and consistent therapies. Thus, in this study,~     the investigators focus more specifically on resistant auditory hallucinations in~     schizophrenia, which is a common symptom in schizophrenic patients, and can be treated by~     rTMS. The investigators hypothesize that there is a baseline difference in anatomical and/or~     functional connectivity between responder and non-responder patients who are treated with~     rTMS. Therefore, our project will aim to determine some anatomical and functional~     connectivity markers of response to rTMS treatment in patients with schizophrenia~   "
23039|NCT02755610|"~     Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal~     Disease (ESRD) patients under the PD First policy of the Universal Coverage (UC) scheme.~     The increased demand has resulted in not only supply chain logistical problems, but also~     product quality concerns. Peritonitis, the main complication and main cause of failure in~     Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by product~     defect. This cluster randomized trial will be conducted in participating Peritoneal Dialysis~     Outcomes and Practice Patterns Study (PDOPPS) centers in Thailand to assess if a check list~     intervention could reduce peritonitis rate and increase the number of product defect report.~   "
31546|NCT02644174|"~     In this prospective study we will evaluate the changes in respiratory physiology occurring~     in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical~     Center of Israel (SCMCI).~   "
23041|NCT02755584|"~     Background:~      Cellular senescence is the aging of cells. It is a complex process that may be connected~     with aging and age-related diseases. It is unknown if these cells appear around wound sites~     in humans a few days after skin injury and if there are differences in young and old~     individuals. This study is being done to look at how cells in your body respond to small~     skin wounds. This information may help treat age-related diseases.~      Objective:~      To study how cells in the body respond to small skin wounds.~      Eligibility:~      Healthy adults ages 20-39 or 70+~      Design:~      Participants will be screened with medical history, physical exam, and blood sample. They~     will fast before the screening visit. Women will have a urine pregnancy test.~      Participants will have 3 study visits over about 3 weeks.~      Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine~     test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed.~     Two small pieces of skin will be removed. They will keep the area covered until the next~     visit.~      Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be~     measured and photographed.~   "
23042|NCT02755558|"~     In this study, the investigators varied both the energy density and portion size of milk~     served with a meal commonly consumed by preschool children. The milk used in this study is~     commercially available and reflects typical variations in energy density. The primary aim of~     the study is to investigate the independent and combined effects of milk energy density and~     portion size on preschool children's intake of the milk and the simultaneously served meal.~     The effect of milk energy density and portion size on children's total energy intake at the~     meal will also be evaluated.~   "
23043|NCT02755545|"~     The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of~     use in adult men and women with mild to moderate facial acne, at least 5 inflammatory~     lesions, and at least 10 - 100 non-inflammatory lesions.~      Objective:~        1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week~          2, week 6, week 12, and week 24 as compared to baseline and compare between treatments~        2. To characterize the effectiveness of the acne treatment in Investigator's Global~          Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~        3. To characterize the effect of the acne treatment in clinical grading of efficacy~          parameters through digital images at week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~        4. To characterize the effect of the acne treatment in subject self-assessment~          questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~   "
23044|NCT02755532|"~     Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem,~     making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little~     evidence exists regarding the effect of different concentrations of this drug on peak plasma~     levels. The present study compares two bupivacaine concentrations to establish how the~     concentration and exchange area affect the peak plasma level of this drug during axillary~     brachial plexus block. Latency and postoperative analgesia periods were also compared.~      Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of~     0.25% bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was~     injected per nerve. Peripheral blood samples were collected every 15 min during the first~     hour and every 30 min during the second hour to establish serum level dosage.~     High-performance liquid chromatography coupled with mass spectrometry was used for the~     analysis.~   "
23045|NCT02755519|"~     To optimize the confirmatory tests for primary aldosteronism.~   "
23046|NCT02755506|"~     The study aims to evaluate the role of endobronchial ultrasound elastography in~     differentiated diagnosis of benign and malignant thoracic lesions~   "
23047|NCT02755493|"~     This project proposes to both develop and test adaptive automation countermeasures for the~     effects of stressors such as sleep deprivation (SD) on human performance related to robotic~     tasks, and investigate the relationship between human trust and appropriate use of these~     countermeasures.~   "
23048|NCT02755480|"~     Patients with bone marrow cancer are more susceptible to chest infections than healthy~     adults; marrow ablation treatment further compromises their immune status and increases the~     risk of fungal opportunistic infection, which is associated with a high fatality rate.~     Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when~     these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health~     Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised~     (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).~   "
23049|NCT02755467|"~     To evaluate the safety and effectiveness of the laser treatment for the treatment of spider~     angiomas.~   "
23050|NCT02755454|"~     The goal of this study is to determine specific perfusion patterns for radiation induced~     lung changes and residual/recurrent lung malignancies in patients treated with stereotactic~     body radiotherapy SBRT and thus improve to distinguish radiation changes from~     residual/recurrent lung cancers. Currently CT is often unable to make a clear~     differentiation between benign and malignant changes in the lung after SBRT treatment~     necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment~     may be delayed. The investigators want to apply a CT perfusion sequence in addition to the~     routine follow up CTs with the goal to obtain perfusion values of post treatment lung~     changes and lung tumours. The investigators' hypothesis is that CT perfusion values will~     help differentiate benign post radiation changes from residual/recurrent tumour in the lung~     with higher confidence and may help avoid unnecessary delays in cancer treatment.~   "
23051|NCT02755441|"~     All incident cases of idiopathic pulmonary fibrosis (IPF) in Denmark will be offered~     inclusion during a 2 year period and followed up for at least 1 year with measurements of~     serum biomarkers and measurements of disease progression.~   "
23052|NCT02755428|"~     This project intends to transplant the clinical grade human embryonic stem cells derived~     retinal pigment epitheliums into subretinal space of patients to treat dry age-related~     macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants~     to treat dry AMD.~   "
23053|NCT02755415|"~     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted~     gait training system for acute stroke survivors. It is anticipated that robot-assisted gait~     rehabilitation will achieve significantly better gait and quality of life outcomes than the~     standing table rehabilitation.~   "
23054|NCT02755402|"~     Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but~     underrepresented among those who are treated, despite many studies showing that treatment is~     feasible and effective in this population.~      The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step~     is a potential occasion for disengagement and loss to follow-up. This is especially true~     with hard-to-reach populations such as PWID in whom competing needs are numerous and~     psychosocial situation can change rapidly.~      By using new technologies that can quickly provide clinical results, like Xpert HCV Viral~     Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a~     patient needs treatment rapidly or not on the day of the initial visit.~      The aim of this study is to explore whether an accelerated pre-treatment evaluation can~     result in an improved linkage-to-care (defined as linkage to health care, addiction or~     social services) and, eventually, linkage-to-treatment among PWID.~   "
23055|NCT02755389|"~     This is a randomized clinical trial investigating the utility of apneic oxygenation via~     nasal cannulae in the post-induction setting for the purpose of prolonging the safe apneic~     time. Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min~     group. The primary outcome will be the difference in the partial pressure of oxygen in~     arterial blood (PaO2) between groups throughout the nine-minute apneic period.~   "
23056|NCT02755376|"~     Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL)~     injury using stem cell.~   "
23057|NCT02755363|"~     The purpose of this study is to determine whether the selected osteopathic techniques have a~     positive impact on the residual volume decrease in patients with chronic obstructive~     pulmonary disease with severe and very severe airflow limitation in comparison to the manual~     therapy not aimed to decrease hyperinflation (placebo).~   "
23058|NCT02755350|"~     Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers~     (FSWs) and young women (YW) as part of a defined package of HIV combination prevention~     intervention for 12 months in 5 sites in Kenya. The project will assess adherence, adverse~     events, side effects, user satisfaction, cost, facility preparedness and provider~     competencies. PrEP eligibility and screening tools for MSM, YW and FSWs will be piloted and~     validated. Pregnant women will be enrolled in a sub-group and followed through 12 months~     post- partum to measure mother and infant outcomes that include health status, birth~     outcomes, birth defects, risk behavior and PrEP adverse effects. With lessons from initial~     PrEP studies in West and Central Africa, this project will apply good participatory practice~     guidelines through 1) continuous engagement with communities of FSWs, YW and MSM and 2)~     development and use of a communication engagement and advocacy strategy that will provide~     correct information, address attitudes and concerns whilst increasing demand for PrEP~     uptake. The actual cost of delivering HIV combination prevention which includes PrEP will~     also be assessed and cost effectiveness modeled.~   "
23059|NCT02755337|"~     To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome~     after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General~     Hospital, Surabaya, Indonesia.~   "
23060|NCT02755324|"~     Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma~     mansoni cercariae until 10 volunteers are found infected.~   "
23061|NCT02755311|"~     The role of transarterial chemoembolization (TACE) as the standard therapy for~     intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies~     which showed that liver resection (LR) is a safe and feasible procedure with better survival~     outcomes than TACE does.~      In light of this, the investigators have constructed a Markov model to simulate comparing LR~     and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may~     provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic~     patients. However, validating the simulated result by a study with higher quality (e.g.~     prospective clinical trial) would be of great value in providing a more convincing finding.~     Therefore, based on the established Markov model, the investigators aimed to prospectively~     compare the treatment efficacy and safety of LR with TACE for consecutive patients with~     intermediate-stage HCC.~   "
23062|NCT02755298|"~     The study seeks primarily to determine the chronic clinical effect of AZA on exercise~     capacity (6MWD) compared to placebo.~   "
23063|NCT02755272|"~     The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy~     (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic~     triple negative breast cancer.~      Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells.~     Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and~     metastatic non-small cell lung cancer. However, it has not been approved as a treatment for~     breast cancer.~   "
23064|NCT02755259|"~     To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with~     pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation~     (RHC).~   "
23065|NCT02755246|"~     The overall objective of this study is to examine the effect of polyamine supplementation on~     cognitive performance of individuals with subjective cognitive decline.~   "
23066|NCT02755233|"~     Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM~     before and during treatment with ipilimumab are performed. A reduction from baseline of~     forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus~     indicative for pulmonary toxicity.~   "
23067|NCT02755220|"~     This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in~     Aortic Valve Replacement and Mitral Valve Replacement in Chinese population~   "
23068|NCT02755207|"~     The purpose of this study is to evaluate the potential diagnostic and prognosis value of~     circulating microRNAs compared with cTnI for suspected ACS patients at the emergency~     department (ED) and intensive care unit (ICU).~   "
23095|NCT02754856|"~     The goal of this clinical research study is to learn if tremelimumab in combination with~     MEDI4736, FOLFOX (fluorouracil, leucovorin, and oxaliplatin), and bevacizumab can help to~     control colorectal cancer that has spread to the liver. The safety of these drugs will also~     be studied.~   "
23096|NCT02754843|"~     The purpose of this study, which contains a series of successive study parts, is to~     methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant~     quality control prior to each product launch.~   "
23069|NCT02755194|"~     Some medications taken by the breastfeeding women are excreted into milk, posing a potential~     risk of toxicity to the infant. The first line of evidence required for toxicity risk~     assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information~     of drug excretion into milk is largely lacking, or limited to data from case reports. This~     makes it difficult to provide population-level prediction of drug levels in milk. The lack~     of data on this topic jeopardizes not only maternal adherence to drug therapy during~     breastfeeding but also establishment of breastfeeding, even if the drug is considered safe~     during nursing. Clearly, this clinical problem in drug safety is an important women's health~     issue, affecting both mother and infant. Drugs in Lactation Analysis Consortium (DLAC) is~     a drug-in-milk monitoring network, which is designed as a platform for efficient~     collection of patient milk samples in a real world setting to generate population~     predictions of drug excretion levels into human milk.~   "
23070|NCT02755181|"~     This study aims to use resting-state and task based functional Magnetic Resonance Imaging~     (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with~     borderline personality disorder.~   "
23071|NCT02755168|"~     Caesarean section is one the most common operations worldwide, its rates are globally~     increasing. A multitude of efforts had been done aiming at reduction of Caesarean section~     related maternal morbidities; most of them are related to technical modifications of how to~     open and how to close the abdominal and uterine incisions . The comparative studies of blunt~     versus sharp extension of the uterine incision showed a reduction of the incidence of~     unintended extension from 8.8% to 4.8% .~      The vulnerability of the lower uterine segment for tears are related to stage of labor. The~     frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in~     first and second stages of labor respectively.~      The original techniques of fetal head extraction entail the introduction of the~     obstetricians hand or other instruments into the lower uterine segment . This puts the lower~     uterine segment at risk of damage and incision extensions with its consequences of increased~     blood loss, increased operative time, infection adhesions and blood transfusion. Adherence~     to the available the generated good quality evidence bases practice in Caesarean section is~     anticipated to decease such morbidities (4-6).~      The idea of the present technique was derived from the fact that during vaginal delivery the~     main task of obstetrician is to support the perineum while the fetal head extends to get out~     through birth canal.~   "
23072|NCT02755155|"~     Primary purpose : mortality at Day 28~      Secondary purposes :~        -  Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care~          Unit (ICU)~        -  Duration of increasing doses of norepinephrine infusion to maintain target mean~          arterial pressure~        -  Number of care-related infections within ICU~   "
23073|NCT02755142|"~     This study is planned to detect a dose-efficacy relationship between the chosen dose levels~     of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with~     newly diagnosed malignant glioma.~   "
23074|NCT02755129|"~     The aim of this study is to evaluate sit-stand phases and gait speed detection using an~     externally worn Reveal LINQTM compared to an external reference (3D accelerometer, and/or~     the Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the~     Netherlands~   "
23075|NCT02755116|"~     Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic~     techniques have improved and pressure to reduce health-care costs has increased. While there~     are many benefits to recovering from surgery within the home, a significant disadvantage is~     the lack of rapid access to a healthcare provider when postoperative complications occur.~     Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent~     studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV)~     after ambulatory surgery, particularly in high-risk groups (female gender, age less than 50~     years, history of PONV, opioid administration in the post-anesthesia care unit (PACU), and~     nausea in the PACU). Current practices known to reduce the risk of postoperative nausea and~     vomiting in the PACU, such as the avoidance of volatile anesthetics and the use of~     intraoperative ondansetron and steroids, have little effect on the risk of delayed PDNV.~     Novel strategies to prevent PDNV are needed. Orally administered olanzapine, which has been~     shown to decrease the incidence of chemotherapy-induced nausea and vomiting, demonstrates~     promise as a novel strategy for preventing PDNV. It has a long half-life, allowing for a~     single dose to be administered preoperatively. This study will evaluate whether there is a~     difference in the incidence and severity of PDNV between patients who receive oral~     olanzapine versus placebo prior to general anesthesia for ambulatory gynecologic surgery.~   "
23076|NCT02755103|"~     The current study will modify an already existing therapy for individuals with substance use~     disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance~     use disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has~     been shown to help individuals to cope with stress and regulate emotions. Through meditation~     practice women will experience less distress related to PTSD symptoms and reduced substance~     use in response to emotional triggers. Women enrolled in intensive SUD treatment at a~     community program will be randomized to receive either 8 weeks of 90 minute Mindfulness~     Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone.~     The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of~     feasibility of implementation, acceptance and adherence will be obtained. Preliminary~     efficacy for substance use and PTSD symptom severity will be measured at post treatment and~     at 3- and 6- months' follow-up.~   "
23077|NCT02755090|"~     This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of~     inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl~     and midazolam, for pain management in adult women having a pregnancy termination procedure~     between 12 and 16 weeks gestational age.~   "
23078|NCT02755077|"~     Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of~     this study is to determine if head rotation improves the efficiency of mask ventilation of~     anesthetized apneic adults.~   "
23079|NCT02755064|"~     With this study, the investigators hoped to learn if the rate at which food empties from the~     stomach affects blood sugar values. Using data from this study, we hope to improve our~     ability to control blood sugars in individuals with type 1 diabetes mellitus.~   "
23080|NCT02755051|"~     Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo~     8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and~     ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will~     be assessed at the end of session 3. Treatment enactment will be assessed throughout~     treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime~     behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month~     follow-up.~      Study Flow:~      Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16~     --->Follow-up (wk 17-18)~      Session:~        1. Sleep education~        2. Sleep scheduling, limit setting, and stimulus control~        3. Teaching relaxation strategies and other adaptive coping skills~        4. Parenting strategies (differential attention, rewards, consequences)~        5. Identification of maladaptive & adaptive cognitions~        6. Problem solving & communication skills~        7. Sleep restriction; bright light to change circadian rhythms~        8. Review gains and plan for long-term maintenance~   "
23081|NCT02755038|"~     The investigators hypothesis is that we can determine estrogen and progesterone levels in~     the hair by using the immune method and we can show a significant difference in the levels~     of these hormones in both groups of women: pre- and postmenopausal women. If indeed it would~     then be possible in future to carry out research that can find a relationship between the~     levels of these hormones and various diseases~   "
23082|NCT02755025|"~     The SOFA score is a severity of illness and prognostic score used in the ICU. It has also~     recently been adopted as part of the definition of sepsis. This study will prospectively~     evaluate the usability of automated SOFA scoring for ICU patients within an electronic~     patient monitoring dashboard. It will also assess for changes in physician ordering (volume~     and types of orders) after automatic scoring is implemented.~   "
23083|NCT02755012|"~     This study takes place in rural Mam-Mayan communities of Guatemala characterized by high~     rates of childhood stunting. It aims to characterize women's exposure to nutrition,~     infection and psychosocial stressors vs. resilience factors, to evaluate the cumulative~     impact of maternal-level factors (nutritional, infectious, psychosocial), social factors~     (autonomy, social support, domestic violence), and household factors (socioeconomic status,~     food security) on early infant growth, and to evaluate whether maternal cortisol may be a~     mediator in the vertical transmission of stress.~   "
23084|NCT02754999|"~     In this open-label study, eligible and consenting adult patients admitted for critical care~     that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are~     unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more~     infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the~     acute anemic episode.~   "
23085|NCT02754986|"~     This study assesses autonomic nervous system function by power spectral analysis of RR~     interval dynamics in ultrafiltration subjects without blood pressure variation.~   "
23086|NCT02754973|"~     The aim of this study is to examine the effectiveness of an integrated experiential training~     with healthcare professional coaching program in promoting regular physical activity among~     childhood cancer patients. Half of the participants will receive the integrated experiential~     training with healthcare professional coaching program, while the other half will receive~     the placebo control.~   "
23087|NCT02754960|"~     Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a~     major therapeutic challenge.~      Methods: The investigators performed a randomised, double-blind, placebo-controlled, single~     centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or~     placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent~     gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes~     of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed~     a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time~     daily, and monitored for at least one year. The primary end point was defined as the~     patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was~     defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color~     technology) at any visit after treatment. Secondary outcomes included the changes from~     baseline in participants dependent on blood transfusions and transfused packed red cell~     units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months.~     Statistical significance was defined at P < 0.05.~   "
23088|NCT02754947|"~     The goal of this study was to identify the etiology of events and demographics of patients~     that experience complications requiring activation of the Rapid Response Team (RRT) during~     the first 24 h following anesthetic care.~   "
23089|NCT02754934|"~     This study evaluates, if the movement of the cervical spine, assessed via a specific~     questionnaire by the patient, is a valid and reliable tool and could be used in daily~     clinical routine.~   "
23090|NCT02754921|"~     The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia~     Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect~     to procedure difficulties and complications.~   "
23091|NCT02754908|"~     This study aims to examine the effects of musical training on improving the neurocognitive~     function and psychological well-being of children surviving brain tumours. Half of the~     participants will receive weekly 45-minute lessons on musical training for one year (52~     weeks) while the other half are the placebo controls.~   "
23092|NCT02754895|"~     This trial is part of a multi-phase study to develop and test positive psychology (PP)~     interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a~     factorial design, the investigators will: (a) assess the optimal frequency of exercise~     completion, (b) determine the utility of 'booster sessions' after an initial 8-week~     intervention, and (c) determine the relative merits of utilizing PP exercises alone versus~     an intervention combining PP with motivational interviewing (MI).~   "
23093|NCT02754882|"~     This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of~     bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent~     non-squamous non-small cell lung cancer (NSCLC).~   "
23094|NCT02754869|"~     This project involves the development, validation and application of a novel test using MRI~     to assess gastrointestinal motility a vital process that mixes the contents of our digestive~     tract. This process frequently becomes deranged in conditions like chronic constipation,~     Parkinson's and Crohn's disease.~   "
23097|NCT02754830|"~     The purpose of this study is to evaluate the safety and tolerability of the study drug,~     LY3303560. Side effects and laboratory results will be monitored. This study will involve~     single doses of LY3303560 administered intravenously (IV), meaning into a vein or~     subcutaneously (SC), meaning under the skin.~      Screening is required within 28 days before the start of the study for healthy participants~     and within 42 days before the start of the study for AD participants. The study requires~     about 16 weeks of each participant's time including a 4 day clinical research unit (CRU)~     admission and 10 follow-up appointments.~      This is the first time that this study drug is being given to participants. This study is~     for research purposes only, and is not intended to treat any medical condition.~   "
23098|NCT02754817|"~     This study is conducted in Europe. The aim of the study is to investigate the effectiveness~     of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2~     diabetes mellitus.~   "
23099|NCT02754804|"~     Vascular claudication is a common cause of functional limitation. This painful condition is~     a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient~     leading gradually to a state accented inactivity. The characterization of the claudication~     as it results from a proximal or distal ischemia has never carried out. Investigators will~     analyze dynamic pedometer parameter throughout walking tests in PAD patients with~     claudication~   "
23100|NCT02754791|"~     Bloodstream infections cause significant morbidity and mortality and their prompt~     identification is an essential part of modern medicine. False positive results in blood~     cultures are primarily due to contaminants. It has been estimated that up to 50% of positive~     blood cultures represent contamination. These false positive cultures, at the~     microbiological laboratory level, require significant additional resources for workup.~     Additionally, they result in unnecessary antibiotic treatment and hospitalization days,~     causing needless harm to patients. Various methods have been implemented in order to reduce~     blood culture contaminants, including modifying the solution used for sterilizing the skin~     and feedback on contamination rates. However, it has been shown that the bacteria which~     colonize the human skin are not only on the surface but in fact colonize deeper surfaces as~     well. The SteriPath device diverts the initial 1-2 ml blood so as to remove any potential~     skin plug with contaminants. Thus, the principle object of this study is the determination~     of the rate of contamination of blood culture taken prior to initiating intervention versus~     the rate of contamination using three interventions: Monthly feedback via departmental~     report card, a chlorhexidine plus alcohol wipe and the SteriPath device. Secondary~     objectives will include ease of use of the wipes and the SteriPath device and an estimate of~     the sensitivity of SteriPath device use to true bacteremia. If the various interventions~     will be shown to reduce contamination, researchers will also attempt to estimate the~     financial effects of those reductions, comparing intervention cost to estimated savings~     related to reduced contamination.~   "
23101|NCT02754778|"~     Evaluation of practicability in survey and test procedures and of successful implementation~     of complex interventions - feasibility analysis based on a pilot study: Influence of~     conditional workout postpartum on arterial stiffness among women with status after~     preeclampsia, superimposed preeclampsia or HELLP-syndrome~   "
23102|NCT02754765|"~     endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority,~     multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened~     regimens for multidrug-resistant tuberculosis (MDR-TB).~   "
23103|NCT02754752|"~     The goal of this clinical research study is to compare 3 types of interventions (involving~     electro-acupuncture and standard care) that are given to women with chronic post-surgical~     pain after a mastectomy. Researchers want to find out which intervention may be most~     effective in relieving breast pain. The safety of these 3 interventions will also be~     studied.~   "
23104|NCT02754739|"~     An increased risk of incident diabetes with statin therapy have been reported in several~     studies. However, it is not recommended to limit the use of statin for this reason since the~     absolute risk increase was small, and the cardiovascular event rate reduction with statins~     overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin~     may have different effect on the development of incident diabetes. In the West of Scotland~     Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by~     30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the~     improvement in insulin sensitivity, has been reported. In this clinical trial, the~     investigators are aiming to evaluate the effect of pravastatin on insulin resistance,~     insulin secretion, glycemic control, and adiponectin level in participants with prediabetes~     or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a~     placebo group.~   "
23105|NCT02754726|"~     The purpose of this study is to find out if the study drugs nivolumab, albumin- bound~     paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective~     when combined to treat advanced pancreatic cancer.~   "
23106|NCT02754713|"~     The study will aim at investigating novel plasma or imaging biomarkers in patients with~     acute pericarditis. All participants will be treated according to established clinical~     recommendations for the diagnosis and treatment of acute pericarditis.~      Study participants will undergo blood sampling for measurements of plasma biomarkers~     potentially involved in the pathogenesis of acute pericarditis. Imaging datasets from~     available imaging tests will be used to quantify imaging biomarkers. Patients will be~     followed up prospectively for up to 18 months. The prognostic value of plasma and/or imaging~     biomarkers for development of complications such as atrial fibrillation, pericarditis~     recurrences, constrictive pericarditis and/or the need to switch to 2nd line treatment will~     be sought.~   "
23107|NCT02754700|"~     This study will identify the most optimal, focused approach for biofeedback in adolescent~     females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized,~     pre/post-testing design will be used to identify biofeedback training effects. The~     investigators will also determine the effects of hip strategy on retention of decreased knee~     abduction load with focused biofeedback. A six-month follow-up design will be used to test~     retention of real-time biofeedback intervention.~   "
23108|NCT02754687|"~     The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone~     Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.~   "
23109|NCT02754674|"~     1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome~          using two anterior cruciate ligament reconstruction techniques ; transportal technique~          with flexible reamer and single bundle outside in technique with remnant preservation.~        2. Subjects: anterior cruciate ligament (ACL) injury 66 patients~             -  Double bundle transportal technique with flexible reamer: 33~             -  Single bundle outside in technique with remnant preservation: 33~   "
23110|NCT02754661|"~     The primary objective of this multicenter, prospective, randomized study is to assess the~     diagnostic yield of CCE versus CTC in a screening population.~   "
23111|NCT02754648|"~     Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather~     than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman~     with ovarian endometrioma or not?~   "
23112|NCT02754635|"~     Induction of labor at term versus expectant management among women with abnormal maternal~     biochemical markers. A randomized controlled trial~   "
23113|NCT02754622|"~     Many patients who are admitted to the intensive care unit (ICU) experience muscle weakness.~     This muscle weakness occurs whilst patients are unconscious, immobile in bed and on a~     breathing machine (ventilator). It can develop very quickly, as soon as they become unwell.~     The investigators know that this weakness can make it harder for patients to regain their~     normal level of functional ability, such as standing and walking independently. Physical~     rehabilitation, delivered by physiotherapists, is important for patients as they recover~     from their critical illness to help them regain strength and to practice the ability to~     perform physical activities. These activities include sitting on the edge of the bed,~     standing, stepping on the spot and walking.~      However it is difficult to know how hard it is for patients who are recovering from critical~     illness to perform these types of activities - in other words, how much energy is required.~     Some patients may find certain activities harder or easier than others. By knowing the~     energy requirements of patients whilst they take part in different physical rehabilitation~     activities, physiotherapists may be able to be more accurate with prescribing exercises and~     designing rehabilitation sessions for patients to practice achieving those activities.~      In this study, the investigators will measure the energy requirements of the patients when~     they take part in physiotherapy-led physical rehabilitation they will have during their~     admission. To do this, the investigators will use a different ventilator to the one normally~     used to help their breathing. This ventilator works in exactly the same way, but has an~     extra component built into it to measure energy requirements. After the rehabilitation~     session, the patient will return to using their normal ventilator.~   "
23114|NCT02754609|"~     This trial is a Phase 1b multicentre, multinational, randomized, double-blind with~     single-blind arm and open label extension phase, placebo controlled, clinical trial~     evaluating the safety and predictability of an escalating gluten consumption to activate~     Coeliac Disease (CeD) in (a) a small cohort of people with diet-managed CeD treated with a~     placebo (n=10), and in (b) cohorts following low (L3-10; n=40) and medium (L3-20; n=10) dose~     hookworm inocula.~      The investigators 4 aims for the study are:~      Aim 1: Undertake a multiple-phase and escalating gluten challenge assessing safety to gluten~     exposure in hookworm-naïve and hookworm-infected people with CeD.~      Aim 2: This phase Ib study recognizes that the evidence supporting this novel intervention~     is rudimentary and addresses amongst others the following questions: (a) The importance of~     L3 dose on Participant health, and (b) the importance of L3 dose on the safety of escalating~     gluten challenge and (c) the need for a comparator group should a phase II trial be~     warranted.~      Aim 3: Examine the changes in intestinal T cell responses induced by hookworm infection and~     gluten exposure.~      Aim 4: Assess the impact of hookworm infection and purified hookworm-derived proteins on~     gluten peptide-specific immune responses ex vivo.~   "
23115|NCT02754596|"~     This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant~     to timolol ophthalmic solution.~   "
23116|NCT02754583|"~     SWIFT is a series of 3 cluster-randomized trials designed to assess several alternative~     strategies for trachoma control in communities that have been treated with many years of~     mass azithromycin distributions. The first trial (named WUHA) compares communities that~     receive a comprehensive Water, Sanitation, and Hygiene (WASH) package to those that receive~     no intervention. The second trial (named TAITU-A) compares communities randomized to~     targeted antibiotic treatment versus those randomized to mass antibiotics for trachoma, and~     the third trial (TAITU-B) compares communities randomized to targeted antibiotics versus~     those randomized to delayed antibiotics.~   "
23117|NCT02754570|"~     The aim of this study will be to determine the effects of pilocarpine as an adjunct~     medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and~     compare these effects to latanoprost alone.~   "
23118|NCT02754557|"~     The purpose of the study is to compare the efficacy of a physiologically-augmented~     breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are~     associated with psychological trauma, as well as symptoms of posttraumatic stress disorder~     (PTSD). The study will evaluate whether physiological augmentation produces a greater change~     in dissociative symptoms, meditative engagement and attentional control, compared to~     non-augmented mindfulness. The augmentation comprises physiological feedback in the form of~     a vibration on the wrist. Vibrations are delivered by a device that will be placed on a~     participant's arm; the device vibrates in proportion to the person's breath.~   "
23119|NCT02754544|"~     The goal of this clinical research study is to learn if using a larger than the standard~     mapping grid currently used at MD Anderson during brain tumor surgery or a high-definition~     grid for electrocorticogram (ECoG) brain mapping can help better identify which areas of the~     brain are active during specific limb movement and speech. In this study, the result of two~     types of ECoG mapping grids will be analyzed.~      ECoG mapping will take place during participant's scheduled surgery. Before the procedure,~     participant will be assigned one of the two types of mapping grids. The mapping grid will be~     placed directly on the surface of participant's brain during surgery. Participant will not~     be able to feel this. The grids contain electrodes attached to a computer to record brain~     activity. A wireless digital glove will be used with the high-definition grid. The glove~     records hand movements, while the grids shows the areas of the brain that are active during~     the hand movements.~   "
23120|NCT02754531|"~     This study aims to compare the accuracy of measurement between ultrasonography and Cole~     formula in predicting uncuffed endotracheal tube diameter.~   "
23121|NCT02754518|"~     This study intends to measure the effects of valsartan/sacubitril compared to baseline~     standard medical heart failure therapy on reverse remodeling using echocardiographic~     endocardial surface analysis techniques to assess changes in ventricular volume, function,~     and shape. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to~     mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk~     reduction. The investigators also intend to measure the effects of valsartan/sacubitril on~     exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on~     cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of~     valsartan/sacubitril on functional status and quality of life using the Kansas City~     Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that~     incorporates Fitbit technology to provide a real time daily 6 minute step count and~     assesses quality of life using a series of short targeted questions. The investigators will~     also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic~     Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at~     multiple time-points throughout the study period.~   "
23122|NCT02754505|"~     Background: Few studies showed that early rehabilitation on the Intensive Care Unit (ICU)~     results in a better functional outcome at hospital discharge and reduced hospital stay.~     Effects of early rehabilitation at the general ward directly after transfer from the ICU on~     the length of stay (LOS) in hospital and on the functional outcome are missing.~      Methods: In a prospective randomised controlled trial (RCT) 53 consecutive~     critical-illness-survivors were enrolled at nine ICUs. Early rehabilitation program~     (protocol) consisted of exercise therapy, active breathing techniques and electrical~     stimulation after discharge from the ICU to ward-based care. The usual care group received~     physical therapy as ordered by the primary care team after discharge from the ICU. LOS at~     the general ward after transfer from the ICU was recorded. Furthermore,~     Early-Rehabilitation-Barthel-Index (ERBI), Visual-Analogue-Scale for pain (VAS),~     3-Minute-walk-test (3min), Beck-Depression-Inventory (BDI), State-Trait-Anxiety-Inventory~     (STAI), and Medical-Research-Council-scale (MRCS) were assessed.~   "
23123|NCT02754492|"~     To verify that platelets collected on the Trima Accel system with Version 7.0 software~     enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 ×~     10^6 residual white blood cells [WBC] per transfusable unit).~   "
23124|NCT02754479|"~     To evaluate the safety and effectiveness of the Excel V system for the treatment of lower~     extremity spider veins on the ankles.~   "
23125|NCT02754466|"~     The present study aims evaluate the oral health conditions of schoolchildren and its~     relation to growth, development and well-being. Also, it seeks to evaluate different~     restorative interventions performed at school premises in primary teeth and its impact on~     the quality of life.~   "
23126|NCT02754453|"~     There are three different phases to this study:~        1. Screening phase to determine if you are eligible to participate in the study.~        2. Study phase, which will entail diet and activity, exercise and then finally self~          monitoring goals.~        3. End of treatment phase where you will be asked to complete questionnaires.~   "
23127|NCT02754440|"~     To verify that platelets collected on the Trima Accel system with Version 7.0 software~     enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for~     leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).~   "
23128|NCT02754427|"~     Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance~     model with arm assessment pre-surgery followed by ongoing surveillance and targeted~     physiotherapy treatment after breast cancer surgery may improve early detection and~     management of arm morbidity. This study aims to determine the effect of prospective~     surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance~     group compared to control group at 12-months after breast cancer surgery.~   "
23129|NCT02754414|"~     This is a platelet transfusion study. The purpose of this study is to measure the life span~     and quality of platelets preserved in an additive solution and stored in a refrigerator.~     Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A~     small portion of the subject's own stored platelets will be tagged with a radioactive~     isotope and infused back into the participant. This will enable us to track how many~     transfused platelets survive after storage in the refrigerator.~   "
23130|NCT02754401|"~     200 patients took part in the questionnaire and were examined using the PSI. Thereafter the~     participants were divided into two groups, non-periodontitis persons (group 1; PSI 0-2) and~     periodontitis persons (group 2; PSI 3-4). The answers were evaluated using a point system~     ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of~     influence. Receiver-operating characteristic (ROC) curve analyses were applied to examine~     the overall discriminatory power, sensitivity and specificity, and corresponding cut-off~     points of the self-reported periodontal disease scale.~   "
23131|NCT02754388|"~     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis~     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought~     to be the best screening tool for lung cancer. However, there is growing concerns about~     radiation exposure, high cost, and high rate of false-positive screening result.~     Epidemiologic studies from western countries showed that cigarette smoking is the major~     cause of lung cancer, and other risk factors may include age, environmental pollution,~     occupational exposures (included of radon exposure), gender, race, and pre-existing lung~     diseases. Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable~     to smoking. The investigators need a different risk prediction model adapted to the~     investigators country.~      National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by~     LDCT since June 2015. Many people can get the LDCT screening with affordable price with the~     subsidy from enterprise donation. The purpose of this study is observing those participants~     with 2-year follow-up. Furthermore, those data may connect with another study of Low dose~     computed tomography screening study in nonsmoker with risk factors for lung cancer in~     Taiwan （Non-smoker study）which is implemented in other hospitals in Taiwan.~   "
23288|NCT02752347|"~     Compare the impact of using rapid maxillary expanders on masticatory muscle activities~     (Masseter and Anterior Temporalis muscles) between the cross-bite side and non-cross-bite~     sides of the same preadolescent orthodontic patient before the expansion and after one month~     of the completion treatment period using surface electromyography device.~   "
23132|NCT02754375|"~     Biological markers of depressive states have been studied, but their usefulness to predict~     the therapeutic response is unknown. This issue is major in all depressive states which have~     not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic~     stimulation) is a non-pharmacological alternative in the treatment of depression, but its~     effects on cerebral functioning are not known in episodes which have resist to conventional~     treatments. The investigators will include 50 depressive patients who have failed to respond~     to two successive antidepressant medication, and propose them a treatment with low frequency~     rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission~     tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in~     order to measure induced metabolic changes and their correlation with clinical states.~     Patients who have responded to rTMS acute treatment may continue this therapeutic for six~     months, and the investigators will assess if efficacy maintenance is related with cerebral~     metabolic variations~   "
23133|NCT02754362|"~     This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed~     of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with~     polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and~     bevacizumab in adults with recurrent glioblastoma.~   "
23134|NCT02754349|"~     This study aims to evaluate the reliability of measurements of arterial stiffness (pulse~     wave velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and~     pulse pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled~     for electrical cardioversion will be included. PWV and PWA measurements will be carried out~     before and after cardioversion.~   "
23135|NCT02754336|"~     This pilot study compares the effect of working memory training and neurofeedback in~     non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive~     working memory training, while the other half will receive neurofeedback.~   "
23136|NCT02754323|"~     There are different definitions of stress according to each discipline. In psychology, it is~     defined according to the individual's ability to adapt. The medical approach focuses on the~     reactions of the body to stress situations. And the organizational approach seeks to define~     in terms of sources of stress situations. According to a national interprofessional~     agreement on stress at work in 2008 is defined as a condition that occurs when there is an~     imbalance between the perception of a person with constraints imposed by its environment and~     the perception that it has its own resources to cope.~      Stress at work~      INRS emphasizes prevention to fight against the cost of work stress and seeks to develop~     methods and tools objectification stressful situations. The social cost of workplace stress~     would represent 10 to 20% of the expenses of the branch for employment injuries /~     occupational diseases of the Social Security According to a survey by the European Agency~     for Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all~     lost working days. The cost of occupational stress assessed by INRS represent 830 million~     euros in 2000 in France.~      Media coverage of working conditions related suicides has prompted some companies to~     communicate about work stress and develop actions.~      According to the study of Sumer in 2003, 61% of employees have a highly stressful job and~     27% complained of work-related health problems.~      However, the 2009 survey shows that job stress is a major risk factor for mental health and~     is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm,~     stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic~     stress as soon as possible to prevent burnout.~      Stress testing procedures~      The major problem is that there is not now comprehensively measure of stress. The~     measurement models that are available to date, all incomplete, can be classified according~     to two categories.~      First, the general patterns that measure only partially stress but which can be used in any~     type of fields. One application of self-KARASEK and the imbalance of effort / reward~     SIEGRIST. These two models are mainly used for epidemiological studies on job stress.~      Second, the specific models that provide a more comprehensive measure but we can only use in~     the area from which they come. These measure specific stressors (organizational,~     professional and emotional) in the study population.~      The main objective of this study is evaluate the feasibility and validate the measurement of~     chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA~     tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and~     KARASEK. This method explores finely enough constraints and allows a comparison of national~     data.~   "
23137|NCT02754310|"~     Repeated exposure to simulated cases has been shown to improve performance, but repeating~     the same scenario may impair the ability of learners to transfer their knowledge and skills~     to slightly different situations. The objective of this study is to compare the use of~     repeated versus varied simulation cases for teaching the management of pediatric asthma~     exacerbation to 3rd year medical students.~   "
23138|NCT02754297|"~     In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate)~     will be personalized, i.e. administered activity of LuTate will be tailored for each patient~     to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.~      The purpose of this study is to:~        -  Assess the objective (radiological), symptomatic and biochemical response rates~          following an induction course of personalized PRRT;~        -  Assess the overall, the disease-specific, and the progression-free survival following~          P-PRRT;~        -  Correlate therapeutic response and survival with tumor absorbed radiation dose;~        -  Evaluate the acute, subacute and chronic adverse events following P-PRRT;~        -  Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed~          radiation doses to organs at risk;~        -  Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20~          patients (sub-study funded by the Canadian Institutes of Health Research).~      This study also has a compassionate purpose, which is to provide access to PRRT to patients.~   "
23139|NCT02754284|"~     This study is carried out to explore the short-term and long-term efficacy of the functional~     collagen scaffold in guiding laryngeal soft tissue regeneration.~   "
23140|NCT02754271|"~     Exercise training for older hemodialysis patients can greatly improve many of the negative~     effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet~     to be incorporated effectively and systematically into routine care. Exercise programs~     remain rare. When such programs are implemented, their participation rates vary, and they~     neglect home and community-based activities, as well as the involvement of family caregivers~     to support and reinforce exercise. This study is intended to address these limitations by~     introducing a highly accessible and compelling educational film, Fit for Dialysis, designed~     to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis~     patients, and exercise counseling and support by family caregivers, nephrologists, and~     nurses. The objective of this clinical trial is to determine whether and in what ways Fit~     for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance~     of exercise-based principles of wellness in the context of end-stage renal disease.~     Ultimately Fit for Dialysis could be used as a model for dialysis education that supports~     guideline recommendations that exercise be incorporated into the care and treatment of~     dialysis patients.~   "
24737|NCT02733380|"~     This is a prospective phase II clinical trial to observe the efficacy and safety of~     Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and~     thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).~   "
23141|NCT02754258|"~     The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy~     of diet and exercise to sustain weight loss over the long term is weak. While~     pharmacotherapy is more effective than behavior intervention in maintaining weight loss the~     effects are often not sufficient to achieve optimal health benefits. Current drug treatments~     may be sub-optimal because they do not directly target the rewarding value of food, drive to~     eat, food liking, and impulsivity for eating energy dense snack foods, all of which~     influences both quantity and quality of food intake and impacts adherence needed to maintain~     weight loss.~      The Solution: The limitations in current anti-obesity agents are potentially addressed by~     Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger~     and food reward, as increase resting energy expenditure in obese and non-obese~     adults;however, no controlled field trials have been conducted in obese individuals without~     ADHD.~      Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and~     women. Secondary: to examine the effects of MPH on energy expenditure, body weight,~     impulsivity, food reward, and olfaction. The investigators predict that compared to placebo,~     MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell~     function.~      Deliverable: This study may be the first to establish the short-term efficacy and safety of~     using MPH for weight loss, and if successful, data will inform a larger trial that can~     potentially identify MPH as a novel therapeutic agent for treating obesity and related~     chronic diseases in a predisposed population.~   "
23142|NCT02754245|"~     The aim of this study is to externally validate a new emergency department overcrowding~     estimation tool (SONET) developed at John Peter Smith Health Network (JPS).~   "
23143|NCT02754232|"~     Problem:~      Training is an important part of the treatment and rehabilitation of patients with chronic~     obstructive pulmonary disease (COPD) because training can increase the patient's muscle~     mass, lead to higher physical performance, reduce difficulties in breathing and hereby~     increase the patients' capacity to make use of the medical treatment.~      Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the~     transport is too tiring for the patients, which is why they decline taking part in it. This~     can mean a worsening of their condition and an increase in readmissions.~      Solution:~        -  To develop a better treatment for patients with severe COPD: Telemedical training of~          patients with COPD in teams.~        -  To develop a cross-sectoral practice for the telemedical training patients will use,~          thus decreasing the readmissions of OUH's patients with severe COPD~        -  To optimize the patient's journey in and across sector borders by using Lean methods.~      Perspective:~      The study is expected to contribute to improving treatment of severely ill patients with~     COPD cross-sectorally. The results are expected to contribute to reducing readmissions and~     raising the level of evidence in telemedical research on training patients with severe COPD.~     The study's findings may be of use in relation to other patient groups who have difficulties~     coming to training.~      Background:~      This research project has its starting point in a pilot project. Its goal was to determine~     whether severely ill COPD patients could train at home and earlier than normal. Evaluation~     showed patients found it reassuring to train with the help of the COPD briefcase. They found~     it increased their physical and mental well-being.~      Method:~      To gain knowledge of the effect of telemedical training. The patient's strength, daily~     activity level and quality of life will be measured by conducting a randomized controlled~     trial including 125 patients - 62 in the intervention group and 62 in the control group.~      Qualitative research methods will be used to explore the user perspective concerning~     patients, family and health professionals. The method is critical psychological practice~     research.~      A Lean method consultant from University Hospital Odense (OUH) will be involved in~     developing the best clinical pathway for the patients and the professionals.~   "
23144|NCT02754219|"~     The objective of the study is to compare the pharmacokinetics profiles and safety of~     Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral~     dose of Evogliptin~   "
23145|NCT02754206|"~     The purpose of this study is to understand how biochemical markers in blood, balance~     disturbances, and cognitive performance are related to brain blood flow changes after a~     concussion.~   "
23146|NCT02754193|"~     A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C)~     during 24 hours ± 1h versus normothermia (37°C ± 0.3 °C), comparative open trial will be~     conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.~      The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between~     33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality~     in comparison with the normothermia group (37°C ± 0.3°C).~   "
23147|NCT02754180|"~     Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma~     With R1 Resection and/or Positive Lymph Nodes after curative resection.~   "
23148|NCT02754167|"~     Anticalins® are engineered human proteins that are able to bind specific target molecules.~     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin~     and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall~     investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of~     PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.~   "
23149|NCT02754154|"~     The purpose of this study is to compare the risk of major bleeding event among nonvalvular~     atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.~   "
23150|NCT02754141|"~     The purpose of this study is to assess the safety, tolerability, pharmacodynamics,~     anti-tumor activity, and pharmacokinetics of BMS-986179 when combined with nivolumab in~     patients with advanced cancer.~   "
23151|NCT02754128|"~     The purpose of this study is to compare a motor learning (ML)-based gait-related training~     intervention to a functional lower limb strength training intervention, with a concurrent~     evaluation of functional, neural and participation outcomes for children and youth with~     Cerebral Palsy (CP).~      This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS~     Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait~     training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months~     post-intervention.~   "
23162|NCT02753985|"~     This is a qualitative study which explores the role that partners play in breast cancer~     survivors adherence to aromatase inhibitors and management of their side effects. Both~     patients and their partners will be interviewed (separately) in order to capture multiple~     perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary~     method of data collection will be face-to-face semi-structured interviews. These interviews~     will be audio-recorded.~   "
23289|NCT02752334|"~     This study evaluated the motor and sensory block duration and the postoperative analgesic~     effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular~     brachial plexus block Anesthesia. Motor and sensory block duration were considered as a~     primary endpoint.~   "
23290|NCT02752321|"~     The purpose of this study is to determine whether the addition of a mobile or web based~     multimedia discharge application (eDischarge) to the discharge process is effective in~     improving patient experience, engagement, and clinical outcomes in the early post discharge~     period.~   "
23152|NCT02754115|"~     Peritoneal carcinomatosis is a common event in the natural history of colorectal and other~     digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal~     chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients~     with peritoneal carcinomatosis arising from different malignancies such as colorectal~     cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both~     patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal~     and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º~     C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all~     microscopic metastasis.~      CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during~     debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC~     phase, and even in the early postoperative period, with resultant significant morbidity and~     mortality. Despite that most of the reported patients are in American Society of~     Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the~     morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated~     team of anesthesiologist, surgeons and intensivist and other ancillary services can result~     in good outcome. This study will see the challenges faced by the team regarding the~     pathophysiological alterations during the CRS with HIPEC in the perioperative period.~   "
23153|NCT02754102|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
23154|NCT02754089|"~     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known~     as Somagh on body weight.~   "
23155|NCT02754076|"~     The study's primary objectives are to evaluate the safety and tolerability of BMN 250~     administered to subjects with MPS IIIB via an ICV reservoir and catheter and to evaluate the~     impact of BMN 250 on cognitive function in patients with MPS IIIB as assessed by the~     Development Quotient.~   "
23156|NCT02754063|"~     Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and~     its intensity is directly related to the neurological outcome. The thresholds for~     irreversible tissue damage following TBI indicate a particular vulnerability of injured~     brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in~     the intensive care unit (ICU).~      The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure~     (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow~     flow. To prevent ischemia due to elevated ICP, current international guidelines recommend~     maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain~     hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might~     occur despite optimization of CPP and ICP, and have been independently associated with~     poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown~     to be an independent predictor of unfavorable outcome and death. The aggressive treatment of~     low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy~     in cohort studies of severely head-injured patients. On the basis of these findings, it is~     hypothesized that an early optimization of brain oxygenation, together with keeping ICP and~     CPP within recommended values, could reduce the volume of vulnerable lesions following~     severe TBI and possibly improve neurological outcome.~   "
23157|NCT02754050|"~     The device is intended to endoscopically transect polyps in the gastrointestinal tract~     (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is~     captured, retrieved and submitted for pathological analysis. The Tandem Snare is an~     intervention tool inserted through the colonoscope for the resection and removal of polyps~     sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the~     polyp, lift it up, resect and remove it without losing it. This is a feasibility study~     aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in~     screening, diagnostic or surveillance colonoscopy.~   "
23158|NCT02754037|"~     The goal of this study is to evaluate non-invasive imaging techniques for determining liver~     steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue~     scarring).In addition, the study group will be using other test measures including personal~     demographics, laboratory blood test results, and imaging measurements to determine the~     severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis),~     inflammation, and fibrosis.~   "
23159|NCT02754024|"~     In the past years several shoulder reconstruction systems with different types of prostheses~     and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a~     wide range of pathologies and revision situations. The aim of the present study is to report~     radiological and clinical outcome with a stemless shoulder implant with hollow screw~     fixation.~   "
23160|NCT02754011|"~     The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced~     or metastatic breast cancer HER2 negative patients and divided into 2 parts:~        -  STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and~          pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.~        -  STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib~          and capecitabine association on a longer follow-up, and to obtain preliminary evidence~          of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients.~          Up to 14 patients in each cohort, taking into account patients already included in step~          one at this DL, may be enrolled, for a total of 28 at the RP2D.~   "
23161|NCT02753998|"~     The primary objective of this double-blind study is to compare the frequency of primary~     patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either~     by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by~     conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with~     paclitaxel).~      The other objectives of the study are:~        1. To compare the frequency of primary patency at 3 months and 12 months.~        2. To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12~          months.~        3. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous~          fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow~          rate).~        4. To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml /~          min.~        5. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.~        6. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care,~          initial treatments, monitoring, diagnosis and treatments of complications.~   "
23163|NCT02753972|"~     Background: Mindfulness-based interventions may be effective in reducing the stress that may~     increase both obesity and inflammation.~      Purpose: The purpose of this study was to examine the effects of a mindful eating~     intervention on weight loss and health-related outcomes.~      Methods: Thirty-six obese, postmenopausal women were randomized to a six-week Mindful Eating~     and Living (MEAL) intervention or an active control group (CONT) consisting of nutritional~     counseling, goal setting, and group support. Weight, body mass index (BMI), waist-hip ratio~     (WHR), binge eating, interleukin-6 (IL-6) and C-reactive protein (CRP) were assessed at~     baseline and four follow-up periods up to one year.~      Results: Multilevel analyses showed that the MEAL group had reductions in weight, BMI, WHR,~     binge eating, IL-6, and CRP; the CONT group had reductions in weight, BMI, and binge eating.~     The reductions in binge eating, IL-6, and CRP were greater for the MEAL as compared with the~     CONT group.~      Conclusions: This study suggests that a mindfulness-based eating intervention may promote~     weight loss and reduce a variety of health-related risk factors in post-menopausal women who~     are obese.~   "
23164|NCT02753959|"~     Patients with NMD can suffer from a range of respiratory problems due to respiratory muscle~     weakness. Cough muscle weakness worsens secretion clearance from the airways, and increases~     the risk of infection. As a result, these patients often require chest physiotherapy or are~     supported with devices to aid clearance (such as mechanical insufflation-exsufflation) to~     reduce the risk of infection. Although evidence supports the use of these devices, the~     optimal technique or settings on the device are not clear.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air. It allows a non-invasive assessment of the effect of each secretion clearance~     technique on lung ventilation in real-time.~      This study aims to compare how well the lung is filled with air between three different~     techniques for secretion clearance (clearing mucus and phlegm from the airways), in order to~     determine which of the techniques is the most effective, in patients with NMD.~   "
23165|NCT02753946|"~     The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin)~     as non-inferior to piperacillin/tazobactam in overall success (clinical cure and~     microbiologic eradication) for the treatment of hospitalized patients with complicated~     urinary tract infections (cUTI) or acute pyelonephritis (AP).~   "
23166|NCT02753933|"~     This study aims to evaluate whether direct access from General Practitioners (GPs) to~     Magnetic Resonance Imaging (MRI) for patients with chronic headache decreases overall NHS~     costs and increases patient satisfaction compared to clinical practice with referral to~     Neurology Services.~   "
23167|NCT02753920|"~     Voiding difficulties are common after prolapse and incontinence surgeries. All patients~     after vaginal prolapse surgery must complete a voiding trial if they are to be discharged~     home without a catheter. Accepted protocols for voiding trials after prolapse and~     incontinence surgeries do not exist. The purpose of this study is to compare two different~     types of postoperative voiding trials to determine which leads to less postoperative issues,~     such as urinary retention requiring catheterization. You are being asked to participate~     because you are having a vaginal apex suspension surgery.~   "
23168|NCT02753907|"~     Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30~     kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group~     (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50)~     maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice~     and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and~     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8~     week alongside other cardiovascular disease risk factors.~   "
23169|NCT02753894|"~     The objective of this study is to examine the clinical dose range of ASP1585 based on the~     efficacy, safety, and feasibility of treatment in chronic kidney disease patients on~     hemodialysis with hyperphosphatemia.~   "
23170|NCT02753881|"~     Patients with primary and secondary liver cancer may participate in this study. The purpose~     is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on~     the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization~     (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an~     injection of small beads to block the tumor-feeding arteries. Doxorubicin is a~     chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin~     pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive~     super-selective CTACE (i.e., delivered in close proximity to the tumor).~   "
23171|NCT02753868|"~     The purpose of this study is to examine the effect of cycling at mild to moderate intensity~     during hemodialysis treatment on cardiovascular function in a crossover design.~   "
23172|NCT02753855|"~     The purpose of this study is to characterize plasma and urinary concentrations of telavancin~     following intravenous administration of a single dose of telavancin in healthy subjects who~     are normal weight, overweight, and obese.~   "
23173|NCT02753842|"~     This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with~     women (MSW) in a double-blind, three-way randomized crossover trial with conditions of~     fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based~     on combinations of length (approximately 10 mm increments) and circumference (approximately~     2 mm increments), with user-determined size based on a paper template measurement~     instrument.~      Participants will be randomly assigned to the sequence in which the crossover intervention~     conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for~     each condition. Participants will attend at least four, and up to seven, biweekly study~     visits.~   "
23183|NCT02753712|"~     The purpose of this study is to demonstrate improvement of peripheral airway resistance~     (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).~   "
23184|NCT02753699|"~     The purpose of this study is to follow-up with participants from feeder studies who achieved~     sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability~     of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma~     and post-treatment safety over time.~      Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301~     (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks~     with a maximum of 3 visits. No treatment is involved.~   "
23174|NCT02753829|"~     The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention~     and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital.~     The target population was individuals who have completed the training phase of~     cardiovascular rehabilitation program, volunteers and referenced by the responsible for the~     service.~      This study has as main objective to analyze the influence of a specific exercise program,~     maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6~     months, using a virtual format (computer and Kinect) or a conventional format (paper manual)~     in subjects with coronary artery disease. It was intended to analyze the immediate effect of~     exercise program on body composition and food consumption patterns, functional muscle~     strength of lower limb, level of physical activity: total volume of activity as well as the~     profile of this intensity, kyphotic index, balance, cognitive and executive function, as~     well as in the quality of life.~      The aim is also to examine the effects, approximately 3 months after the end of the exercise~     program, in the lipid profile, the level of physical activity: total volume of activity as~     well as the profile of this intensity and cardiovascular fitness: maximum double product ;~     metabolic equivalents; and proof and recovery time.~      The individuals were distributed at random, every 3 individuals, using the capabilities of~     Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a~     cardiovascular rehabilitation program, in home care context, using a computer and Kinect,~     virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home~     care context, using a paper-based manual, conventional format, and control group-only~     subject to education for cardiovascular risk factors.~      The program defined 3 training sessions per week. The rehabilitation program was oriented by~     the guidelines for exercise prescription.~      Participants perform the a program of specific exercises independently and individually,~     with remote supervision, using communication (phone, email, etc.) and a routine scheduled~     individual meetings.~   "
23175|NCT02753816|"~     Major surgery can result in blood loss that can require a blood transfusion during and/or~     after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's~     as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and~     studied in patients undergoing open-heart surgery, liver transplantation, and urologic~     surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to~     major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and~     possibly decreased hospital costs related to your stay.~      In this study, prior to each surgical procedure to treat the participants burn injury, the~     participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid~     that looks like the tranexamic acid medicine, but does not have any active ingredient in it.~     In this study, both the tranexamic acid and the placebo are considered research.~   "
23176|NCT02753803|"~     A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate~     the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and~     pioglitazone 30 mg after oral administration in healthy male subjects~   "
23177|NCT02753790|"~     Some cancers can spread, or metastasize, to the brain. When they do, treatment often~     involves surgery and/or radiation. Optimal treatment of brain metastases would maximize~     disease control and minimize toxicity (or side effects), and improve the quality of life of~     patients. A common type of radiation used for brain metastases is called whole brain~     radiation, which treats not just the cancer that can be seen on scans (i.e., gross disease),~     but the smaller sites of cancer that may not be visible (i.e. subclinical disease).~     Fractionation is used to describe repetitive treatments in which small doses (fractions) of~     a total planned dose are given at separate clinic visits. The most common dosing regimen is~     30 Gray (Gy), using 3 Gy per fraction over 10 fractions. Previous studies have suggested~     that using intensity modulated radiation therapy (IMRT) may be a safer way to deliver higher~     doses to gross disease and lower doses to the rest of the brain that may contain subclinical~     disease. This approach may spare the rest of the brain from radiation complications and side~     effects.~      The goal of this study is to determine whether using IMRT to treat brain metastases is more~     effective than current standard whole brain radiation in controlling gross disease and~     whether patient quality of life and hair loss is improved compared to previous studies using~     whole brain radiation.~   "
23178|NCT02753777|"~     Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that~     pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP~     will require the availability of validated disease severity measures that can be used to~     define primary outcomes.~   "
23179|NCT02753764|"~     This is a double-blind, placebo controlled 4 week crossover study to investigate the~     efficacy and safety of AZD7624 (an inhaled p38 inhibitor) in corticosteroid resistant (CR)~     asthmatics. For the purpose of this study 10 symptomatic CR asthma patients with a FEV1%~     predicted <80% and normal bronchodilator response, 10 CS asthmatics and 10 healthy controls~     will be recruited.~   "
23180|NCT02753751|"~     This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them~     to usual care versus one of several electronic alerts, which vary by level of intrusiveness.~   "
23181|NCT02753738|"~     Background:~      Conclusive evidence states that the serotonergic system mediates neuroplasticity from early~     embryonic development until brain maturation in adulthood. This study aims to demonstrate~     that selective serotonin reuptake inhibitors (SSRIs) enhance learning-dependent~     neuroplasticity in vivo, hereby contributing to the investigators understanding of the~     mechanism of action of therapy with SSRIs.~      Objectives:~        1. To prove a positive influence of SSRIs on structural remodeling during learning,~          reflected by enhancements of gray and white matter microstructure, connectivity and~          functionality in brain regions involved in learning processes.~        2. To show that this effect is topologically specific, i.e. that enhancements of~          plasticity markers are found in different regions depending on their involvement during~          the performance of specific learning tasks.~      Study design:~      Randomized, double-blind, placebo-controlled, longitudinal mono-center study. 80 healthy~     subjects will undergo three MRI scanning sessions: 1. baseline, at study entry, 2. after 3~     weeks of facial/emotional (n=40) or Chinese character-meaning learning (n=40) and 3. after 3~     weeks learning of new associations under administration of an SSRI or placebo.~      Methods:~      MRI measurements will be performed on a 3 Tesla PRISMA MAGNETOM MR scanner. Changes in gray~     matter microstructure will be assessed using high-resolution structural MRI and analyzed~     with voxel-based morphometry (VBM). Diffusion tensor imaging (DTI) enables non-invasive~     investigation of neuroplasticity in the human brain based on the reduction in mean~     diffusivity associated with swelling of astrocytes after increased synaptic activity.~     Resting-state functional MRI (fMRI) will allow for the measurement of changes in functional~     coupling between brain regions, and fMRI during tasks will assess differential activity in~     brain regions during learning.~      Relevance and implications:~      This study aims to provide evidence that SSRIs facilitate cytoarchitectonical restructuring.~     In addition to expanding the investigators current knowledge on the trophic effects of~     SSRIs, the results of this study will also elucidate interactions between the serotonergic~     system and changes to neuronal networks during learning as well as their behavioral~     consequences. By probing the neurobiological correlates of the antidepressant and~     anti-anxiety effects of SSRIs, this study will provide a rationale for targeted~     interventions that harness the neuroplasticity enhancing properties of SSRIs to facilitate~     therapeutic processes.~   "
23182|NCT02753725|"~     This study will be a randomized double blind placebo controlled clinical trial among~     children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl~     given at a dose of 1ug/while the placebo arm will be given normal saline at a volume~     equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the~     end of surgery determined by the time when the mouth gag will be removed. The main outcome~     will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will~     be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.~   "
23185|NCT02753686|"~     Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of~     these results to patients in the real-world setting is challenging, given RCTs are conducted~     in highly selected patient populations.~      An understanding of the effectiveness and safety of approved cancer therapies in routine~     clinical practice is essential in order to optimize the management of these patients and to~     identify treatment and safety gaps.~      This is the first Canadian study to describe real-world treatment patterns/sequencing,~     effectiveness and safety for postmenopausal HR+ HER2- advanced breast cancer patients. This~     registry incorporates an observational prospective cohort design and will enroll 320~     postmenopausal HR+ HER2- advanced breast cancer women that have been previously exposed to~     non-steroidal aromatase inhibitor (NSAI) therapy being treated with endocrine therapy (ET)~     or ET in combination with targeted therapy (TT).~   "
23186|NCT02753673|"~     The purpose of this study is to develop a questionnaire to measure patient expectations of~     breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will~     assist both surgeons and patients by helping provide valuable information to patients about~     what to expect during and after surgery.~   "
23187|NCT02753660|"~     The aim of this study was to compare the successful spinal puncture among patients with~     pendant position in comparison with those who used traditional sitting position for~     caesarean section.~   "
23188|NCT02753647|"~     This is a prospective, single-arm, open-label phase II study of Chidamide in combination~     with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma~     patients.~   "
23189|NCT02753634|"~     Osteoarthritis (OA) is a growing burden in an aging society. There are few proven treatments~     and hence disability contributes to poor quality of life and direct/indirect costs to~     society. OA symptoms include both increased pain and reduced mobility. Strength training and~     aerobic exercise has been shown to improve symptoms in OA; however, the impact of targeted~     mobility and balance training in patients with osteoarthritis is unclear. The investigators~     propose a novel, low-impact exercise modality that improves balance and gait. The results of~     this research project should improve patient options and improve knowledge in OA management.~   "
23190|NCT02753621|"~     The overall objective of this study is to observe the effect of group Vocal performance~     training and performance experience on patients' reported symptoms and quality of life. The~     effectiveness of PD medications varies significantly in different patients depending on~     their symptoms. By using music-based interventions to improve symptoms that may be~     inadequately treated by medications, the investigators hope to improve quality of life in PD~     patients. Parkinsonics: A controlled study of group singing for quality of life and voice~     outcomes in Parkinson disease (PD) is a controlled crossover behavioral intervention study~     of once weekly choral classes for patients with idiopathic PD (progressing toward a group~     performance) and once weekly discussion/support group meetings.~   "
23191|NCT02753608|"~     The study goal consists in the sequential collection of exhaled breath condensates (EBC)~     from patients receiving invasive ventilation. Subsequent Raman spectroscopy aims at the~     identification of putative biomarkers that could enable rapid early distinction of~     Ventilator-associated pneumonia.~   "
23192|NCT02753595|"~     The primary objective for the study is as follows:~      For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of~     eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in~     participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast~     cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the~     metastatic setting.~      For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in~     combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC~     previously treated with up to 2 lines of systemic anticancer therapy in the metastatic~     setting.~   "
23193|NCT02753582|"~     The primary objective is to determine the effect of SOD enzyme on frailty and health related~     quality of life among Indonesian pre-frail elderly.~      The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status,~     morbidity, and hospitalization among Indonesian pre-frail elderly.~      The study hypothesis:~        1. SOD enzyme can improve frailty status and health related quality of life among~          Indonesian pre-frail elderly.~        2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.~        3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.~        4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.~   "
23194|NCT02753569|"~     This feasibility study will aim to assess the potential for functional imaging biomarkers~     (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of~     response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).~   "
23195|NCT02753556|"~     ScreenFlow is a chronic obstructive pulmonary disease (COPD) screening tool currently being~     studied and iteratively developed that incorporates a questionnaire administered on a tablet~     and data from a digital peak flow meter to calculate a risk score to identify the risk of~     developing moderate-to-severe COPD for the participant. The purpose of this study is to~     assess the usability of ScreenFlow deployed as a free-standing kiosk and observe where users~     encounter trouble navigating the system. The kiosk will be situated in a public area of a~     hospital where passersby can approach and fill out a ScreenFlow survey if they meet the~     eligibility criteria. A subset of participants will be asked to participate in a follow-up~     questionnaire about their experience using the system and about any follow-up action they~     may have taken caused by their results from the ScreenFlow screening.~   "
23196|NCT02753543|"~     This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in~     combination with previous chemotherapy in peripheral T cell lymphoma patients who did not~     achieve complete response after 3 cycles of chemotherapy in interim evaluation.~   "
23197|NCT02753530|"~     Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy~     of the study drug, Arimoclomol in IBM patients.~   "
23232|NCT02753075|"~     This study will investigate the longitudinal efficacy of two experimental oral rinses, one~     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per~     Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of~     dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to~     twice daily brushing with a standard fluoride toothpaste.~   "
23198|NCT02753517|"~     Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and~     mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the~     future remnant liver is just performed through its volumetric measurement by computed~     tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular~     function of the future remnant liver that can be disturbed in case of vascular and/or~     biliary obstruction, chemotherapy-induced liver injuries or steatosis in overweight~     patients. Literature data (albeit originating from a single centre in Europe) have suggested~     that (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the~     function of the future remnant liver. The aim of this prospective multicentric study is to~     determine the predictive value of hepatobiliary scintigraphy in assessing the risk of~     postoperative liver failure of extended hepatectomies of 4 or more segments in noncirrhotic~     liver.~   "
23199|NCT02753504|"~     The purpose of this study is to investigate the safety/tolerability and~     pharmacokinetics/pharmacodynamics of CKD-519~   "
23200|NCT02753491|"~     This study designed for primary care practionars for chronic care in primary care. A new~     model of motivational short interview used for intervention. The aim of this study is to~     develop diet and exercise regimens in type 2 diabetic patients.~   "
23201|NCT02753478|"~     Hypothermia may reduce infarct size in patients with acute myocardial infarction if provided~     before reperfusion. Human studies using systemic cooling methods failed to show a reduction~     in infarction size. The use of selective intracoronary hypothermia may overcome the problems~     of systemic cooling.~      The hypothesis of this study is that in patients with acute myocardial infarction, the~     induction of intracoronary hypothermia is safe and feasible.~   "
23202|NCT02753465|"~     During surgery for rectal cancer, there is considerable controversy regarding the optimal~     level of ligation of the inferior mesenteric artery. Several studies have demonstrated the~     benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to~     achieve block dissection of lymph node metastases along the root of the inferior mesenteric~     artery. In contrast, other studies have shown a significant decrease in blood flow after~     inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and~     the long-term outcomes were not significantly different between high ligation of the~     inferior mesenteric artery and low ligation. So, a modified procedure was suggested to~     dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and the~     left colic artery and the artery was ligated below the left colic artery. In the present~     clinical trial, the investigators perform laparoscopic surgery with this management strategy~     in rectal cancer. Thus, the goal of this study is to investigate the short-term and~     oncologic long-term outcomes associated with laparoscopic lymph node dissection around the~     inferior mesenteric artery with preservation of the left colic artery for rectal cancer.~   "
23203|NCT02753452|"~     In Canada, between 3.6% and 7.7% of children under 19 years old are thought to have a~     chronic health condition that results in disability or limits to activity. These young~     people have difficulty finding jobs, attending school, living independently, and forming~     relationships with other people. These poorer life outcomes are partly the result of a lack~     of life skills. Life skills include the ability to solve problems and set goals, which~     allows youth to deal with the demands of everyday life. Several children's treatment centres~     in Ontario offer short-term residential immersive life skills (RILS) programs to provide~     youth with these life skills to help them take on adult roles. RILS programs are very~     promising in terms of making a long-term difference in youths' lives because they provide a~     place where youth can learn by doing, working with peers and taking risks in a safe~     environment. However, we do not yet know how well skills that are learned in RILS programs~     are kept up as time passes or how well RILS programs support broader skills, such as the~     ability to make one's own choices.~      The proposed research will examine these issues and will ask the following questions:~        1. What opportunities are youth given when they participate in RILS programs? What~          specific strategies do RILS service providers use to support youth in learning life~          skills?;~        2. How do youth experience and perceive their participation in a RILS program, before,~          during and after they take part? What do their parents expect and experience in terms~          of their child's participation?; and~        3. What changes do youth experience, particularly in terms of their ability to make~          choices for themselves and their sense of being able to cope with things that come up~          in their lives? The study will involve youth from several treatment centres in Ontario~          over the next three years.~      Youth who are attending RILS programs will be compared with:~        1. youth who are similar to the RILS youth, but who are taking part in a life skills~          program that is not residential;~        2. youth who applied to a RILS program and were accepted, but who will take part in the~          program in a different year; and~        3. a group of youth who are similar to the RILS youth but who are not taking part in any~          life skills program.~      Youth will provide data at four time points: before the program starts, immediately after~     the program finishes, three months after the program is over and 12 months after the program~     is over.~   "
23204|NCT02753439|"~     A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the~     investigators augment unilaterally and compare periodontal parameters in between.~   "
23205|NCT02753426|"~     The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID)~     will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic~     kidney disease.~   "
23206|NCT02753413|"~     The purpose of this study is to assess the safety and reactogenicity of a single~     intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant~     women aged 18 to 45 years.~   "
23207|NCT02753400|"~     To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor~     biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week~     12.~   "
23208|NCT02753387|"~     Surgical site infections are an important health indicator for hospitals and a significant~     medico-economic issue.~      The aim of the study is to assess the impact of chlorhexidine mouthwash performed before~     surgery on the bacterial colonization of the pharyngeal mucosa.~   "
23209|NCT02753374|"~     This study is a multicenter, prospective cohort study of patients diagnosed with cystic~     fibrosis, the clinical information of recruited patients, including clinical manifestations,~     lung function, chest imaging, quality of life and other indicators, will be followed for 10~     years.~   "
23210|NCT02753361|"~     There is limited information on using the ultrasonography for block placement concerning~     lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure~     proper block placement with accurate local anesthetics deposition. Investigators~     hypothesized that ultrasound guidance can reduce the number of needle passes to complete the~     block placement. Investigators will compare namely ultrasound guided regional blockade and~     traditional method regarding the number of needle passes to complete the block placement.~   "
23233|NCT02753062|"~     This is an open-label, multi-center, prospective, single arm phase 2 trial of the~     combination of bendamustine and rituximab in patients with PTLD, monomorphic cluster of~     differentiation antigen 20(CD20) positive DLBCL. The investigators want to investigate the~     efficacy and safety of the combination of bendamustine and rituximab in patients with~     previously untreated PTLD, monomorphic CD20 (+) diffuse large B-cell lymphoma.~   "
23211|NCT02753348|"~     Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the~     Copenhagen area 2016-2018.~      Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen~     saturation and analyses of umbilical cord blood.~      The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the~     prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the~     yield of routine echocardiography shortly after birth and to establish reference values for~     echocardiography in Danish neonates.~      Prospective follow-up of the birth cohort is planned with the purpose to assess the~     life-long development of cardiovascular disease as well as other conditions and to study~     associations between both pre- and postnatal exposure and disease, including life style,~     environmental and genetic factors.~   "
23212|NCT02753335|"~     The intention of this trial is to investigate whether combined Graded Motor Imagery (GMI)~     and Desensitization (D) among patients with CRPS is clinically more effective than only D~     and to study changes in connectivity in the Default Mode Network before and after treatment.~   "
23213|NCT02753322|"~     Stroke is one of the most common chronic disabling conditions in Hong Kong. People after~     stroke may suffer from certain degree of physical impairment and disability. Resuming safe~     ambulation in the community appears to be a big challenge to them as it always involves the~     simultaneous performance of two or more tasks (dual task) such as walking and talking with~     someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that~     the interference from dual tasks (dual task interference) may significantly impact the~     recovery of the functional walking. To date, the relevance of dual task walking to daily~     community is widely documented and the ability of managing dual task is therefore~     particularly important. Evidences supported that dual task training showed its promising~     effect on the balance and walking performance amongst people with neurological disorders,~     such as chronic stroke. In light of this, the introduction of dual task based balance and~     walking training into physiotherapy program for stroke patient may enhance the balance and~     walking performance and hence promote successful community ambulation. Yet, there is limited~     evidence on its effect in sub-acute stroke.~      Objective: To examine the effectiveness of a dual-task based balance and walking training~     program on performance and dual task interference in balance and walking ability, balance~     self-efficacy and incidence of falls in people with sub-acute stroke~   "
23214|NCT02753309|"~     This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity~     during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.~   "
23215|NCT02753296|"~     The aim of this research study is to develop a patient decision aid (PDA), and evaluate~     whether its integration within oncology services enable cancer services to effectively~     support and provide evidence based resources for women's fertility preservation decisions,~     following a diagnosis of any cancer type.~   "
23216|NCT02753283|"~     The purpose of this research study is to find out if denosumab (Prolia®), an injection given~     in the arm under the skin every 6 months, works to treat bone loss and prevent it from~     worsening in older men and women (ages 65 and older) who have osteoporosis and reside in~     long-term care (LTC) facilities.~   "
23217|NCT02753270|"~     Foam sclerotherapy has been established as another option of treatment for varicose veins of~     the lower limbs. Its advantages are the application to patients with high surgical risk and~     immediate return to usual activities. Comparing to laser and radiofrequency, it has lower~     cost and is less painful. Nevertheless, it requires more re-interventions due to venous~     recanalization.~   "
23218|NCT02753257|"~     CereDx has early proof of concept clinical data of a multi-omic peripheral blood biomarker~     profile that can be used to determine stroke from no stroke in the emergency setting. The~     objective of this observational cohort clinical study is to determine the clinical utility~     of this multi-omic biomarker profile.~      Primary Study Aims:~        1. The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke~          (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no~          stroke (stroke mimic).~        2. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from~          hemorrhagic stroke and TIA.~   "
23219|NCT02753244|"~     This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in~     Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to~     evaluate the effects of training on patients' cognitive performance~   "
23220|NCT02753231|"~     The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits~     on hepatic metabolism and cardiovascular health as well as on selected physical fitness and~     mental health outcomes among adolescent overweight/obese from Bogota, Colombia.~   "
23221|NCT02753218|"~     The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731~     on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam~     in healthy male subjects.~   "
23222|NCT02753205|"~     Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable~     hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine~     during laparoscopic lower abdominal surgery, might help to attenuate the increment of~     intracranial pressure and the investigator would observe the optic nerve sheath diameter~     using ultrasonography.~   "
23257|NCT02752750|"~     In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50~     age-matched control subjects will be recruited for their 2 years follow-ups and undergo~     extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI).~     Regional differences of susceptibility and R2* relaxation rates in deep gray matter and the~     neocortex will be evaluated in AD patients and controls and related to the patients´~     cognitive status at baseline.~   "
23258|NCT02752737|"~     Cryo AF Global Registry a prospective, global, multi-center, observational Post-Market~     Registry~   "
23309|NCT02752074|"~     The purpose of the study is to assess the efficacy, safety, and tolerability when combining~     pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic~     melanoma~   "
23387|NCT02751047|"~     The investigator will compare the feasibility of manual ventilation and pressure-controlled~     mechanical ventilation during facemask ventilation in children. The hypothesis is that the~     incidence of gastric insufflation would be lower during pressure-controlled mechanical~     ventilation when compared to manual ventilation.~   "
23223|NCT02753192|"~     Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and~     older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is~     classically characterized by a symptomatic triad that includes rest tremor, akinesia and~     hypertonia and although the motor expression of the symptoms involves mainly the limbs, the~     muscles implicated in speech production are also subject to specific dysfunctions. Motor~     speech disorders, so-called dysarthria, can thus be developed by PD patients. The main~     objective of our project is to evaluate the physiological parameters (acoustics), perceptual~     markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context~     of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be~     physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree~     of impairment of such parameters should be associated with the pathology and be present~     universally in all patients, even if they speak different languages; that should be also the~     case of prosodic markers, whereas impairment of speech intelligibility may participate to~     the psychosocial impact in communication alteration.~      PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60).~     Their global motor disability will be assessed with dedicated clinical rating scales,~     without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched~     volunteers will provide the normal reference for between-group comparisons. Along with the~     off and on medication clinical examinations, several speech tasks will be recorded.~     Moreover, speech organ functions will also be assessed during the same examination. The~     psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be~     analysed a posteriori, as well as the speech intelligibility evaluation, and both will~     strengthen the overall speech assessments. This global investigation will represent a unique~     opportunity to provide the most precise and reliable description of PD patients' speech and~     its impacts on intelligibility and quality of life. Challenging and interdisciplinary~     aspects are combined in our project, which original cross-linguistic approach involves an~     international collaboration definitely new in the field of motor speech disorders.~   "
23224|NCT02753179|"~     Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability~     during head movement called oscillopsia. Visual consequence of vestibular deficit can lead~     to a severe impairment of their quality of life. However, correcting saccades during rapid~     head movement, called covert-saccades, have been more recently identified. These saccades,~     which occur during the head movement in patients with vestibular hypofunction, present a~     very short latency. They could compensate for the lack of vestibular-ocular reflex and~     greatly decrease oscillopsia and visual impairment. The objective of this study is to~     evaluate the potential functional benefice of these compensatory movements in a population~     of 20 patients with chronic bilateral areflexia, in a cross-sectional study.~   "
23225|NCT02753166|"~     To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours~     following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the~     periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and~     emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin~     conductance) in response cued reminders of the trauma; e) enhances the likelihood of~     remission of PTSD symptom severity.~   "
23226|NCT02753153|"~     This study aims at assessing the hard and soft tissues remodelling of the alveolar crest~     after extraction socket managements in the aesthetic areas:~        -  3D radiographic evaluation (CT scan) was performed post extraction and 3 months after~          at the time of implant placement. (Outcomes 1: Hard tissues analyses )~        -  Impressions, models and 3D analyses of the treated area allowed studying external soft~          tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues~          analyses )~   "
23227|NCT02753140|"~     Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in~     locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab~     with radiotherapy after neoadjuvant chemotherapy.~      The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and~     Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.~   "
23228|NCT02753127|"~     This is an international multi-center, prospective, open-label, randomized phase 3 trial of~     the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus~     standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer~     (CRC).~   "
23229|NCT02753114|"~     Acute painful conditions make-up a large proportion of pre-hospital transports in British~     Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide~     analgesia and therefore adequate and timely pain relief is often significantly delayed.~      Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered usual~     care for pre-hospital providers in BC, but its utility in severe pain is uncertain.~     Moreover, nitrous oxide is limited in its effectiveness by a short duration of action,~     nausea, vomiting, and the necessity for patient cooperation.~      IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated~     analgesia in many settings. The investigators believe that the addition of IN ketamine to~     usual care with nitrous oxide inhalation for adults experiencing moderate to severe~     intensity acute pain in the pre-hospital setting will result in improved pain severity,~     improved patient-reported comfort, and improved patient satisfaction.~   "
23230|NCT02753101|"~     Chronic pain can result from injured or inflamed nerves, as happens in people suffering from~     sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause~     of pain in these conditions, but the current diagnostic tools have proven quite limited in~     pinpointing these areas. Several studies have implicated involvement of sigma-1 receptors in~     the generation and perpetuation of chronic pain conditions, while others are investigating~     anti sigma-1 receptor drugs for the treatment of chronic pain. Using [18F]FTC-146, a sigma-1~     receptor (S1R) detector and experimental radiotracer, and positron emission~     tomography/magnetic resonance imaging (PET/MRI), we hope to learn the best approach to~     identifying the site of nerve injury/inflammation (or other tissue injury/inflammation) as~     they related to painful conditions, and, therefore, help identify the source of pain~     generation. We will characterizing the disease in patients suffering from complex regional~     pain syndrome (CRPS) and chronic sciatica, with the overarching goal of optimizing or~     developing improved pain treatment regimens.~      The broad objectives of this study are:~        -  To determine the dosimetry of [18F]FTC-146~        -  To evaluate the safety of [18F]FTC-146 after a single administration~        -  To evaluate the pharmacokinetics and ability of the radiotracer to reflect S1R~          expression in healthy subjects and specific patient subpopulations .~      The study is not designed to induce any physiological/pharmacological effect.~   "
23231|NCT02753088|"~     The objective of the clinical study of the medicinal product for medical use: to compare~     efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with~     relapsing-remitting multiple sclerosis.~      Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to~     March 23, 2016.~      Number of patients, involved into the study of the medicinal product for medical use: 158~     patients.~   "
23234|NCT02753049|"~     This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide~     the advanced knowledge, skills, and experience for the candidate's career transition to an~     independent nurse scientist. Her long term goal is to become a leading nurse scientist in~     designing, implementing, and evaluating technology supported behavioral interventions~     targeted for improved disease self-management (i.e. medication adherence, retention in care)~     among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young~     adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre~     and post-doctoral interdisciplinary research traineeships, the candidate has begun to~     develop the knowledge-base and skills necessary for this goal.~      This award details a 3-year scope of mentored career development through which she will gain~     the foundation for future research endeavors. Specifically, the goals of this proposal are~     to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of~     expert researchers; 2) acquire expertise in health informatics for implementation of~     technology supported behavioral interventions, health disparities, and advanced qualitative~     and mixed methods design and analysis through firsthand experience, didactic interactions~     with mentors, and graduate level coursework; 3) build a network of colleagues and~     collaborators within New York University and elsewhere through this research and~     participation at national and international meetings; and 4) prepare and submit a federal~     research grant (R-21) based upon the skills and findings from this award period.~      The specific research project through which she will accomplish these goals is a proof of~     concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and~     addresses the challenge of adherence to antiretroviral treatment among HIV-infected~     adolescents and young adults. A mixed method design is proposed and the specific aims are~     to: 1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive~     behavioral intervention delivered via remote videoconferencing using smartphones; 2) Obtain~     initial estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and~     self-reported ART adherence, beliefs and knowledge about antiretroviral treatment, adherence~     self-efficacy, and healthcare utilization (retention in HIV care). In summary, the ACCESS~     adherence intervention is consistent with the National Institute of Nursing Research (NINR)~     call for the development of novel interventions to deliver personalized care and real-time~     health information for patients.~   "
23235|NCT02753036|"~     Neurotoxic phenomena are among the most common and difficult to treat side effects of~     chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a~     well-recognized adverse reaction in the peripheral nervous system. Side effects of~     chemotherapy in the central nervous system, however, particularly changes of cognitive~     function (in non-medical literature referred to as chemobrain) are diffuse and difficult~     to attribute to individual cytostatic drugs. The primary purpose of this study is to assess~     cognitive function in patients with ovarian cancer before and after paclitaxel/ carboplatin~     combination chemotherapy with standardized neuropsychological tests and compare the outcome~     to patients with benign gynecological tumors without chemotherapy treatment. Secondary~     parameters include the assessment of olfactory function, total neuropathy score and cytokine~     profiles.~   "
23236|NCT02753023|"~     Critical patients in emergency room are seriously situations that need quickly diagnosis and~     treatment. Different predictors of prognosis can be related with mortality and morbidity~     in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of~     the study is analysis and report data about critical patients in Emergency Departments over~     all country, showing demographic, clinical and prognosis data about that in Brazil.~   "
23237|NCT02753010|"~     The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly~     women, age 75-100, with acute hip fracture. The emptying time will be assessed by the~     paracetamol absorption technique, and lag phase and gastric half-emptying time compared with~     two gender-matched reference groups: elective hip replacement patients, age 45-71, and~     healthy volunteers, age 28-55.~   "
23238|NCT02752997|"~     Patients admitted for heart failure that are provided discharge medication services by a~     pharmacist are less likely to be readmitted within 30 days of primary admission.~   "
23239|NCT02752984|"~     Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally~     Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why~     DVT develops.~   "
23240|NCT02752971|"~     The infiltration of the surgical wound is an effective strategy for postoperative analgesia.~     Nonsteroidal antiinflammatories are useful in this way.~      Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or~     bupivacaine plus diclofenac sodium infiltrating wound appendectomies.~      Method: Comparative, double blind, American Society Anesthesiologist classification~     I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3~     (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic~     consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.~   "
23241|NCT02752958|"~     This multicentre, non-comparative design study will monitor the impact of long term~     management of DH with daily use of a sensitivity toothpaste on the quality of life of a~     population of sensitivity sufferers. Changes in oral health related quality of life will be~     monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will~     be conducted in participants in good general health, with pre-existing self-reported and~     clinically diagnosed tooth sensitivity at screening.~   "
23242|NCT02752945|"~     This is a feasibility trial designed to test the feasibility and acceptability of a one-day~     Cognitive Behavioural Therapy (CBT) workshop intervention (DISCOVER) for young people aged~     between 15-18 years, who are on local child and adolescent mental health services (CAMHS)~     waiting lists, awaiting treatment for difficulties with anxiety and/or depression.~     Participants will be randomised to receive either the DISCOVER workshop (in addition usual~     care) or to continue usual care.~   "
23243|NCT02752932|"~     Primary objectives:~        1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic~          head and neck squamous cell carcinoma for the development of patient derived xenographs~          (PDX) from fresh, real time biopsies in which sensitivity to < 4 Ontario funded~          chemotherapeutic regimen will be tested. Written feedback to the primary oncologist~          will be provided.~        2. There is also a curative intent cohort of 30 participants undergoing surgical resection~          with curative intent. These PDX models will undergo exome sequencing with written~          feedback.~        3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment~          rate, ii) patient status at the time of drug testing completion and iii) rate of~          accrual.~   "
23244|NCT02752919|"~     The study involves a single dose of galunisertib taken by mouth by Japanese participants and~     non-Japanese participants. The study will evaluate the relationship between the effect of~     the study drug on the electrical activity of the heart, as measured by electrocardiogram~     (ECG) and how much of the study drug gets into the blood stream and how long it takes the~     body to remove it. Ths study will last about 42 days for each participant.~   "
23272|NCT02752555|"~     This study is the first to evaluate the effect of oral supplementation with antioxidants~     combined with lifestyle modification for severe male factor partner of couples undergoing~     ICSI.~   "
23245|NCT02752906|"~     The aim of the study is to describe the safety and antibody response to revaccination with~     MenACYW conjugate vaccine in persons who received their first quadrivalent meningococcal~     conjugate vaccine dose at ≥ 10 years of age.~      Primary Objective:~        -  To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal~          serogroups A, C, Y, and W following the administration of a booster dose of MenACYW~          conjugate vaccine compared to those observed following the administration of a booster~          dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first~          vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose.~      Secondary Objectives:~        -  To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W~          measured using human serum bactericidal assay (hSBA) in serum specimens collected 6~          days after vaccination in a subset of subjects~        -  To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W~          measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination~      Observational Objectives:~        -  To describe the antibody titers against meningococcal serogroups A, C, Y, and W~          measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination~        -  To describe the safety profile of MenACYW conjugate vaccine compared to that of a~          licensed MCV4 after booster vaccination.~   "
23246|NCT02752893|"~     The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to~     generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth~     factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to~     develop novel treatment strategies and dissect signaling pathways underlying drug~     sensitivity and resistance.~   "
23247|NCT02752880|"~     Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients~     worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many~     patients who take more than three kinds of oral hypoglycemic agents could not effectively~     control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are~     common side effect with insulin therapy, and many patients in Taiwan are not willing to~     receive insulin injection. It is common for diabetic patients treated with Chinese herbal~     medicine in China currently, and some therapeutic effects have been published in~     international journals. In this study, we will evaluate whether Chinese herbal medicine,~     YH1, enhances the glycemic control and is safe as add-on medication in poorly controlled~     type 2 diabetes patients.~      A total of 80 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 9% from~     Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled~     in this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned~     to receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All~     subjects in both groups will also continuously receive their oral hypoglycemic agents~     without any dose or medicine change. During this 12-week period, the glycohemoglobin,~     fasting plasma glucose, 2h postprandial glucose, waist circumference, body weight, and body~     mass index will be assessed. In addition, insulin resistance, β -cell function, lipid~     profile, liver and renal function will also be evaluated. Independent statisticians will~     perform the data analysis at the end of the trial.~   "
23248|NCT02752867|"~     The purpose of this study is to explore the pathogenesis of cognitive impairment after acute~     cerebral infarction by applying the multimodal function MRI to dynamically observe the~     changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of~     the brain ,and to provide a visual instrument for evaluating the therapeutical effects of~     Chinese medicine through the application of multimodal function MRI to observe the changes~     of the neurotransmitter in certain area in the brain before and after the treatment.~   "
23249|NCT02752854|"~     one measurement of pain threshold in high altitude and in low altitude using pressure~     algometer and Situational pain scale.~   "
23250|NCT02752841|"~     Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and~     kidney stone burden in calcium kidney stone formers~   "
23251|NCT02752828|"~     Primary Objective:~      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline~     to Week 26 in patients with type 2 Diabetes.~      Secondary Objective:~      To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without~     OADs) over a 26 Week treatment period in patients with type 2 Diabetes.~   "
23252|NCT02752815|"~     This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP~     followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of~     Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.~   "
23253|NCT02752802|"~     The purpose of this study is to evaluate the amount of contrast media (CM) saved using the~     DyeVert system in diagnostic angiographic procedures compared to a control group.~   "
23254|NCT02752789|"~     This is a multi-center, prospective, single cohort, observational study of pediatric heart~     transplant recipients designed to determine the impact of preformed versus de novo human~     leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens~     cardiac myosin and vimentin, on chronic allograft function. In addition, the investigators~     will explore mechanisms of action and predictors of DSA, rejection and altered~     pathophysiology.~   "
23255|NCT02752776|"~     Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis patients~     with or without prior exposure to systemic therapy.~   "
23256|NCT02752763|"~     Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic~     medications. For this reason, many patients using isotretinoin are referred to ophthalmology~     clinic because of discomfort symptoms. In the literature, there are studies suggesting~     superiority of Autologous serum drops regarding effects on ocular surface when compared to~     artificial tear. In addition, Autologous serum was also used in several corneal pathologies~     with successful outcomes. No data regarding use in the ocular adverse effects of~     isotretinoin was found in the literature; however, investigators think that it may be an~     effective alternative in the treatment of dry eye developed during isotretinoin use due to~     positive effects on ocular surface, epithelial regeneration and anti-inflammatory effect.~     Autologous serum can be a choice of ophthalmologists in routine practice by increasing~     number of comprehensive studies investigating effectiveness, safety and long-terms effects~     of Autologous serum therapy.In this study, it was aimed to investigate dry eye development~     in the patients receiving systemic retinoic acid therapy and to compare effectiveness of~     Autologous serum and Preservative free artificial tear in the patients with dry eye disease.~   "
23259|NCT02752724|"~     The purpose of this prospective randomized clinical trial is to determine if patients~     receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)~     rather than standard of care will have improvement in symptoms of depression after a course~     of ECT treatments. The investigators hypothesize that utilization of ketamine for induction~     of general anesthesia during ECT treatments will improve symptoms of depression better, than~     standard care.~      This study is ONLY open to patients eligible to receive healthcare services through the~     Department of Veterans Affairs at the VA Puget Sound, which means service in the active~     military, naval or air service or separation under any condition other than dishonorable.~     Qualifications for VA health care benefits can be found at va.gov.~   "
23260|NCT02752711|"~     To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying~     children who are at very low risk of clinically-important traumatic brain injuries after~     minor head trauma has not been validated prospectively in an independent population. Our~     goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a~     French pediatric population in multiple clinical settings.~   "
23261|NCT02752698|"~     Central South University in collaboration with Tianjin University developed the first~     domestically produced Chinese minimally invasive surgical (MIS) robot system which named~     Micro Hand S in 2013. Recently, as the domestic surgical robot research project's main~     section, this new MIS robot had been authorized to enter the clinical trial stage by the~     Ethics Committee of the Third Xiangya Hospital at Central South University.~   "
23262|NCT02752685|"~     This is a single-arm open-label multi-cohort Phase II study evaluating the~     safety/tolerability and clinical activity of the combination of nab-paclitaxel and the~     antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human~     epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There~     will be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort~     with 30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. There will be~     an initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients~     from each cohort). If no unexpected toxicity is observed (as defined in the study protocol),~     then enrollment will continue to complete both cohorts (30 total TNBC, 20 total in HR~     positive cohort). The subjects from the run in safety part will be included in the Phase II~     analysis. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for~     enrollment in the study, but will be assessed as possible predictive marker.~   "
23263|NCT02752672|"~     Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest~     and safest topical anti-psoriatic treatments. However, despite explorative investigations,~     the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al,~     JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of~     dithranol in psoriasis.~   "
23264|NCT02752659|"~     Early detection and treatment of onset or worsening of breast cancer-related lymphedema~     (BCRL) can potentially prevent or postpone the condition to progress into a chronic~     progressive condition or eliminate the risk of infections in the arm (cellulitis).~     Self-surveillance for BCRL by routinely measuring own arm circumference could potentially~     enable early detection of onset or worsening of lymphedema. The aim is to determine whether~     women who have received surgery for breast cancer, can perform self-measures of arm~     circumference in a reliable and valid manner using written and video supported instructions~     without in-person teaching by a physiotherapist.~   "
23265|NCT02752646|"~     This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs~     ketorolac 0.5% among patients undergoing cataract surgery.~   "
23266|NCT02752633|"~     This exploratory pilot study was an open-label, crossover, single-center and non-randomized~     clinical trial designed to compare the effect of the standardly employed doses of~     allopurinol (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine~     (DHA) excretion in patients with adenine phosphoribosyltransferase (APRT) deficiency.~   "
23267|NCT02752620|"~     This study evaluates the effectiveness of treatment osteopathic manipulation in the~     treatment of subjects with chronic nonspecific low back pain.~   "
23268|NCT02752607|"~     Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and~     pulmonary embolism (PE), is the third most common cardiovascular disorder after myocardial~     infarction and stroke. VTE occurs in about 1 person per 1,000 per year, increasing~     dramatically in patients with cancer to about 25 per 1,000 per year. Among the known risk~     factors of VTE, cancer is one of the most potent. Patients with cancer have a 7- to 28-fold~     higher risk for VTE than non-cancer patients. VTE has important implications for the care of~     cancer patients, including reduced life expectancy, high rates of VTE recurrence both while~     on and after stopping anticoagulation, the need for chronic anticoagulation with related~     adverse drug reactions, and delays in cancer therapies. Clinical dilemma: Current clinical~     guidelines recommend a minimum of 3-6 months of anticoagulation with weight-adjusted low~     molecular weight heparin (LMWH) in cancer patients with VTE. However, there are no~     recommendations beyond the initial 6 months of therapy due to the lack of data on extended~     duration therapy for cancer-associated thrombosis (CAT). This leads to variability in~     physician practices, with some continuing weight-adjusted LMWH therapy beyond 6 months. This~     poses concern because, while the goal is to prevent recurrence of VTE, the risk of major~     bleeding with prolonged weight-adjusted LMWH therapy is significant. Potential solutions:~     There is a lack of data to inform on VTE treatment in cancer patients beyond the initial 3-6~     months of anticoagulation. We propose that after a minimum of 3-6 months of therapeutic dose~     anticoagulation, the use of prophylactic doses of LMWH will have an acceptable and adherence~     profile in cancer patients with VTE. The data obtained from this study will help inform~     physician practices. Design: This is a multicentre, open-label study of enoxaparin (40 mg~     subcutaneous injection, once daily) for additional 6 months after an initial minimum~     3-6-month course of therapeutic dose anticoagulant therapy. Patients: 150 patients with VTE~     secondary to cancer will take part in this multicentre study conducted in 8 Canadian centres~     within Quebec, Ontario and Nova Scotia. Study Outcomes: The primary objective of the study~     is to determine the rate of recurrent VTE in patients receiving prophylactic dose enoxaparin~     for secondary VTE prophylaxis after an initial minimum 3-6 months of anticoagulation. The~     secondary objective is to determine the safety profile of prophylaxis dose enoxaparin for~     secondary VTE prophylaxis after an initial 3-6 months of anticoagulation. This includes~     determining for all subjects: 1) cumulative incidence of major bleeding events; 2)~     cumulative incidence of clinically relevant non-major bleeding events; 3) cumulative~     incidence of minor bleeding event, and 4) overall survival during follow-up.~   "
23269|NCT02752594|"~     Dental caries is a multifactorial disease effecting majority of the human population.One of~     the etiological factor causing dental caries is salivary mutans streptococci. Reducing the~     levels of this bacteria in the saliva can significantly reduce the incidence of dental~     caries. A non-invasive intervention, such as the administration of probiotics reduced the~     salivary mutans streptococci levels.~   "
23270|NCT02752581|"~     The study was designed to investigate efficacy of suction drains in arthroscopic knee~     surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were~     randomised, and suction drain was applied to one group, and the other group as the control~     group without a suction drain.~   "
23271|NCT02752568|"~     300 recurrent implantation failure patients will be alternatively assigned to assisted~     hatching , endometrial scratch , and no treatment ,100 patients in each group~   "
23273|NCT02752542|"~     Depression currently affects close to 2 million Canadians and is the leading cause of~     disability worldwide. Pharmacological treatments (antidepressant medication) and~     psychological treatments such as cognitive-behavioural therapy are available for depression,~     but the majority of those who receive treatment have an unsatisfactory response. On average,~     the combination of pharmacological and psychological treatment achieves better results than~     either treatment alone. However, the apparently superior results of combination treatment~     may be due to the fact that different individuals preferentially respond to pharmacological~     or psychological treatment. The invesitagtors have discovered several clinical factors and~     biomarkers that predict poor response to commonly used antidepressant medication: history of~     childhood maltreatment, loss of interest and reduced activity, a biomarker of systemic~     inflammation, and a genetic marker of sensitivity to environment. Indirect evidence suggests~     that the same factors may indicate the need for psychological treatment, but their~     usefulness as differential predictors of psychological and pharmacological treatment~     outcomes remains to be established.~      The investigators will test the hypothesis that a pre-determined set of clinical variables~     (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers~     (serum C-reactive protein, a marker of systemic inflammation, and short alleles of the~     serotonin transporter gene promoter polymorphism) differentially predicts response to~     antidepressants and to cognitive-behavioural psychotherapy with clinically significant~     accuracy.~      If this hypothesis is supported, the resulting predictor will allow personalized selection~     of treatment for depression, leading to improved outcomes and healthcare efficiency.~     Additional objectives include replication of additional predictors and integrative analyses~     aimed at refining the treatment choice algorithms.~   "
23274|NCT02752529|"~     Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of~     Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and~     build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506~     metabolic differences.~   "
23275|NCT02752516|"~     A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study~     the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable~     regimen for subsequent research.~   "
23276|NCT02752503|"~     The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in~     subjects with alcohol use disorder and comorbid BPD.~   "
23277|NCT02752490|"~     The objective of this study is to determine if a strategy of indicated compared to liberal~     oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is~     that women who undergo a strategy of indicated compared to liberal oxygen administration in~     labor will have lower rate of cesarean delivery and fetal acidemia at birth.~   "
23278|NCT02752477|"~     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)~     technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce~     postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery~     when compared with traditional opioid-containing techniques. It is expected that this OFA~     regimen will have a measurable reduction on postoperative opioid consumption and pain scores~     in CPPs.~   "
23279|NCT02752464|"~     Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including~     cardiovascular disease, diabetes, and obesity-related cancers.The successful management of~     overweight/obesity requires management of nutrition and physical activity over time. For~     racial/ethnic minority and low-income populations, who face both higher prevalence of~     obesity and chronic diseases compared to others, interventions promoting behavioral change~     are a national health priority. From the available range of behavioral change intervention~     strategies, there is a growing knowledge base that documents the efficacy of peer support~     interventions for improving self-care, quality of life, and behavioral change. In this~     study, the investigators will examine the following research question: What is the~     preliminary efficacy and degree of implementation and acceptability of an intervention~     approach in which peer counselors provide evidenced-based counseling about nutrition and~     physical activity behaviors for weight management to public housing residents using a~     computer-assisted program called CuesWeight?~   "
23280|NCT02752451|"~     Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy~     skills after receiving prior training with different simulation systems.~   "
23281|NCT02752438|"~     Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive~     to conventional mechanical ventilation both in children and newborns, there is no data on~     its success and the factors that affect its success in the literature.~   "
23282|NCT02752425|"~     Speech is a privileged means of communication for humans: its trouble can thus prove being~     extremely handicapping. Standard speech therapy is limited in some cases by the lack of~     sensory feedback available to the patient (hearing, surgery, neural damage, etc.).~      The present study aims at quantify the contribution of the tongue articulatory visual~     feedback offered by ultrasound echography to speech trouble rehabilitation.~      Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and~     10 childrens with important speech troubles due to central nervous system damage.~      The principle is to conduct standard speech therapy sessions, alternating series of sessions~     with the use of visual feedback and sessions without visual feedback.~      The progress will be regularly measured by means of standard batteries of speech~     articulation tests.~   "
23283|NCT02752412|"~     Primary Objective:~      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline~     to week 26 in patients with type 2 diabetes mellitus.~      Secondary Objective:~      To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in~     patients with type 2 diabetes mellitus.~   "
23284|NCT02752399|"~     The purpose of this study is to verify the applicability Six minutes walk test and Shuttle~     walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients~     will undergo three functional tests, being the six-minute walk test, shuttle walk test and~     cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic~     and ventilatory variables and cardiac monitoring throughout the test.~   "
23285|NCT02752386|"~     The purpose of this study is to test whether a novel form of biofeedback training can help~     individuals regulate their pain more effectively.~   "
23286|NCT02752373|"~     This is an open label prospective study of the impact on healthcare utilization of a surface~     Electromyography (sEMG) based seizure detection system for detecting Generalized~     Tonic-Clonic (GTC) Seizures.~   "
23287|NCT02752360|"~     Intestinal anastomosis plays an important role in various general surgeries, but the~     complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided.~     Although many ways are put up to solve this problem, there are still many imports need to~     improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal~     anastomosis easily and less complications, have been produced.The major goal of this study~     is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in~     surgery of intestinal anastomosis.~   "
23291|NCT02752308|"~     From September 2014 to March 2015, 57 consecutive patients with hypospadias who are~     candidate for surgery will be enrolled in this randomized clinical trial.~      Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of~     the study and all parents will sign a written informed consent.~      Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity.~     Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection ,~     parents' disagreement with the protocol and any cardiac problem that made epinephrine~     injection contraindicated.~      All selected patients will randomly allocate to one of the two groups: group A will receive~     caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive~     general anesthesia before surgery and CEB afterwards. The surgical procedures will be~     performed by a single pediatric urologist (FA). The surgical technique will be tubularized~     incised plate in all cases.~      Intraoperative blood loss will be determined by weighing all surgical gauzes used during~     procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to~     minimize the effect of water vaporization on gauzes weights.~      In addition to blood loss, operation time, dose of fentanyl used during procedure and length~     of the urethral plate defect will be recorded for each patient by trained nurses.~      Demographics and disease characteristics as well as operation details will be compared in~     the two studied groups.~   "
23292|NCT02752295|"~     This study intents to determine who will benefit from an intensive brief stress coping~     intervention week (ISCIW) as secondary prevention for real world affective disorder~     patients.~   "
23293|NCT02752282|"~     This study is a counseling intervention for new LNG-IUS users. The study explores the use of~     video technology to deliver anticipatory counseling on LNG-IUS side-effects, adjustment~     periods and bleeding changes to women newly using the LNG-IUS for contraceptive purposes.~     The primary aim is to understand if anticipatory counseling delivered via video can increase~     LNG-IUS satisfaction and continuation of the device in the first 6 months of use.~   "
23294|NCT02752269|"~     According to the literature available pulmonary hypertension is present in 12 to 23% of~     patients suffering from Sjögren Syndrome. However epidemiological data are based on~     non-invasive measurements using echocardiography. Furthermore, no data are available~     regarding exercise hemodynamics in those patients.~      This study investigates pulmonary hemodynamics at rest and during exercise in patients~     suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for~     pulmonary hypertension (PH) will be offered further investigations including right heart~     catheterization.~   "
23295|NCT02752256|"~     Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during~     air ambulance transfer~   "
23296|NCT02752243|"~     Multi-site, non-randomized Phase I/II study involving children and adults.~   "
23297|NCT02752230|"~     This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine~     0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of~     this study is to evaluate two local anesthetics and determine if there is an advantage of~     administering one medication compared over the other. The intent is show that one local~     anesthetic.allows for improved pain control as per the pain scale ratings of the test~     subjects.~   "
23298|NCT02752217|"~     Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory~     pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung~     function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in~     elderly with Isolated systolic hypertension.~   "
23299|NCT02752204|"~     The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to~     use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The~     trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a~     small number of patients to see if this can be done without increasing the toxicity. 36~     patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6~     will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be~     taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab~     will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum~     of 6 cycles.~   "
23300|NCT02752191|"~     The standard clinical cardiovascular MRI practice for children with CHD frequently involves~     the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs~     are small molecules that quickly cross the capillary wall and access the interstitial space,~     a process which diminishes the signal contrast between blood vessels and surrounding tissue.~     Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the~     images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA~     concentration is much higher in the arteries than in the interstitial space. For young~     children with complex CHD, the stringent requirements for high spatial resolution, and the~     need for cardiac gating and good blood-myocardium contrast in order to provide detailed~     evaluation of intracardiac structures are not compatible with conventional GBCA-based~     first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA~     with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI~     may be insufficient for young children with CHD based on our institutional experience and on~     data from the literature; there remains diminished blood-tissue contrast during the~     high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding~     gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of~     nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2~     years old who may have immature renal function. The long-term health consequences of these~     effects in the pediatric population are unclear. For the above reasons, we seek to study the~     diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for~     parenteral iron supplementation, as an MRI contrast agent in children with CHD. Although~     Feraheme® has been approved for the treatment of iron deficiency anemia secondary to renal~     disease, Feraheme® has been used as an off-label MRI contrast agent at select medical~     centers.~   "
23310|NCT02752061|"~     Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity~     and mortality between low- and middle- income countries (LMICs) and high-income countries.~     Individuals present with advanced stage disease resulting in minimal chance for cure or~     long-term survival.~      The Potlako project will implement and evaluate a multifaceted intervention to test the~     hypothesis that a package of enhanced coordination of care including an electronic~     messaging, transportation support, and training targeted at generalist clinicians at primary~     and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for~     HIV-infected individuals with cancer.~   "
23311|NCT02752048|"~     The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of~     TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.~   "
23301|NCT02752178|"~     This is a study to characterise the role of inflammatory processes in depression. There is~     compelling evidence that inflammation is often associated with, and can cause, depression.~     It is currently less clear that antiinflammatory drugs have meaningful antidepressant~     effect. One of the goals is to identify the subset of depressed patients that is most likely~     to respond better to an antiinflammatory drug than to a conventional antidepressant. The~     investigators will therefore undertake a study of patients with a diagnosis of major~     depressive disorder including four groups: i) incompletely responsive patients who have~     demonstrated failure to respond consistently or completely to standard treatment, ii) those~     who have responded well to treatment and are not currently depressed, iii) untreated~     patients who are currently depressed, iv) healthy volunteers with no history of depression.~     Participants will undergo a clinical assessment, an interview with a trained member of the~     research team and will complete self-rated questionnaires. Investigators will collect blood~     and saliva samples to measure certain immune markers. They will also perform magnetic~     resonance imaging (MRI) scans to look for MRI markers in the brain and investigate brain~     inflammation in a subsample of these patients using positron emission topography (PET) and~     cerebrospinal fluid (CSF) sampling (also called lumbar puncture).~   "
23302|NCT02752165|"~     In the US, children from minority ethnic and racial backgrounds suffer disproportionately~     from asthma and account for substantially more emergency department (ED) visits and~     hospitalizations than non-minority children. While NHLBI guidelines recommend daily~     preventive medications for all children with persistent asthma to prevent morbidity as well~     as ED visits and hospitalizations, many children who should receive preventive medications~     are not receiving them. This is in part because children presenting to the ED for an acute~     asthma exacerbation rarely receive preventive asthma care, due to the ED's focus on acute,~     episodic care. The NHLBI guidelines recommend that children follow-up with a primary care~     provider (PCP) within 1-4 weeks of the ED visit. The post-ED follow-up visit is an~     opportunity for the PCP to prescribe effective preventive asthma medications, step-up~     medication for children who demonstrate poor control, promote adherence, and provide~     education on asthma self-management and trigger control. However, rates for follow-up after~     an asthma-related ED visit are extremely low, and preventive care is delivered~     inconsistently even when children are seen in follow-up. In the investigators' prior work~     they have found that a provider prompting intervention can enhance the delivery of~     guideline-based preventive asthma treatments at the time of a primary care office visit and~     ultimately reduce morbidity. They have also found that telemedicine can link children with~     persistent asthma to a provider for optimal chronic illness management. The goal of this~     project is to use a novel telemedicine-based program to facilitate primary care follow-up~     and promote the delivery of guideline-based preventive care for high-risk children~     presenting to the ED for an asthma exacerbation. The investigators will utilize a 2-group~     randomized trial to test the TEAM-ED intervention. The intervention includes: 1) a~     telemedicine assessment at the child's school within one week of discharge from the ED and~     completed by a PCP, 2) 'point-of-care' prompting to promote the provision of guideline-based~     preventive care during the telemedicine visit, and 3) two additional telemedicine-assisted~     follow-up assessments to assure optimal response to treatment and tailor the care regimen as~     needed. The investigators will assess the effectiveness of the program in reducing~     respiratory morbidity and improving preventive asthma care, with follow-up assessments at 3,~     6, 9, and 12 months.~   "
23303|NCT02752152|"~     The primary objective of the study is to evaluate and compare, in at-risk populations, the~     efficacy of three different counseling methods in terms of propensity to come back for a HIV~     re-test. Secondary objectives are to evaluate and compare the efficacy of the counseling~     methods in terms of reported risk behavior and HIV knowledge as well as their acceptability~     and cost-effectiveness, describe the distribution of duration from HIV primary infection to~     detection, and estimate the prevalence of chronic hepatitis B and C, and syphilis in~     HIV-uninfected participants of targeted populations.~   "
23304|NCT02752139|"~     The purpose of this study is to determine the relationship between sleep disorders and~     cerebral hemodynamics.~   "
23305|NCT02752126|"~     A randomized phase II study of palliative radiation of advanced central lung tumors with~     intentional avoidance of the esophagus. Patients will be randomized between standard of care~     palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy~     (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following~     randomization and subjects will be followed for 1 year after completion of their radiation~     therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal~     Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).~   "
23306|NCT02752113|"~     Diabetes mellitus is a wide-spread disease accompanied by strongly increased morbidity and~     mortality due to micro- and macrovascular complications. However, in studies with patients~     suffering from diabetes mellitus type 2 (DM 2), early changes and impairments in large and~     small blood vessels as well as organ damage (e. g. to the kidneys) have been only~     insufficiently investigated (1). The newest substance class in oral antidiabetics, i. e.~     SGLT-2-inhibitors (such as empagliflozin) cause an increased renal excretion of glucose. In~     addition, the concurrent increased sodium excretion brings about an improvement of vascular~     function and thus a decrease in blood pressure. In the EMP-REG-OUTCOME study (2), the~     cardiovascular mortality rate was significantly lower in the empagliflozin group (3.7%~     versus 5.9%; 38% relative RR) compared to placebo.For another new substance class, the~     dipeptidylpeptidase-4-inhibitors, a number of pleiotropic effects have been described (3).~     In one of our recently conducted trials, we could demonstrate a positive effect of~     linagliptin on renal an inflammatory parameters compared to placebo (4). Thus, the~     combination of both substance classes with regard to positive effects on micro- and~     macrocirculation, even though not sufficiently proven as yet, suggests itself. The therapy~     with metformin and long-acting insulin (BOT), as well as a twofold oral medication is~     possible according to the recommendations of the Deutsche Diabetes Gesellschaft (DDG) and~     the positional paper of the American Diabetes Association (ADA). Accordingly, the aim of~     the present paper is the analysis of the effects of a combined therapy with empagliflozin~     plus linagliptin compared to metformin plus insulin glargine on renal and vascular changes~     in type 2 diabetes mellitus.~   "
23307|NCT02752100|"~     Along with the improvement of living standard, the prevalence of Lower extremity arterial~     occlusive disease (LEAOD) is also increasing, which has become an important cause of lower~     extremity amputation and greatly affected the patients' life quality. Currently,~     percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent~     implantation, has been regarded as the most widely applied and accepted treatment for LEAOD.~     The therapeutic effects of lower extremity interventional treatment, varied in different~     reports. It was reported that the therapeutic effects were influenced by some traditional~     risk factors, including age, gender, smoking, and so on. More risk factors are still~     unknown. The difference of therapeutic effects, the endpoint events were compared between~     interventional and conventional treatment group to analyze the effect of interventional~     treatment on LEAOD and explore its risk factors.~   "
23308|NCT02752087|"~     This study of healthy participants will evaluate the concentration of a test LY900014 and a~     reference LY900014 formulation in the bloodstream and how it affects the blood sugar levels.~     The whole study, including screening, will take up to 8 weeks to complete.~   "
23313|NCT02752022|"~     Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their~     usage is currently under way. People purchase them as an aid to giving up smoking, to reduce~     cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban~     smoking, and in order to continue smoking with decreased health risks. Although the safety~     and impact on health of electronic cigarettes, especially after long-term use, has not been~     evaluated, they are generally considered to be far safer alternatives to cigarette smoke.~     Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of~     carcinogenic chemicals generated during the combustion of tobacco and making important~     contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific~     nitrosamines have been encountered in e-cigarettes being detected in some nicotine~     cartridges as contaminants, albeit at very low concentrations in comparison with tobacco~     smoke. Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming~     nicotine intake through electronic cigarettes. This European Commission funded study will~     monitor levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who~     give up smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels~     of other compounds which are known to be associated with smoking toxicity, such as DNA~     adducts and DNA methylation, will also be monitored in biological fluids of these subjects.~     Finally, cigarette craving, mood, anxiety, social anxiety, well-being status and stress~     hormones will be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the~     psychological effect of the transition. The results from the study will provide important~     information on the safety and effectiveness of e-cigarettes for smoking cessation which~     investigators anticipate to drive policy.~   "
23314|NCT02752009|"~     This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure~     in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla)~     who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant~     therapy).~   "
23315|NCT02751996|"~     This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study~     with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus~   "
23316|NCT02751983|"~     An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public~     health policy both call for treatment targeting high-risk populations, such as Veterans~     hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a~     critical opportunity to provide treatment to reduce the risk of suicide and lay the~     groundwork for functional recovery. Yet, there are no interventions specifically for suicide~     prevention that meet Veterans Health Affairs' quality recommendations requiring the~     provision of evidence-based, recovery-oriented psychotherapy, which are also feasible to use~     during a typical inpatient stay. The proposed study seeks to take a first step toward~     filling this gap. In consultation with experts in the field, the authors have developed a~     protocol applying a recovery-oriented, evidence-based treatment approach to Veteran~     inpatient care. The proposed pilot study will provide critical information to inform final~     revisions of the treatment manual and research design for a future study evaluating the~     efficacy of the intervention.~   "
23317|NCT02751970|"~     This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive~     systems by retention rate of resin restorations placed in non carious cervical lesions with~     four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1~     step self-etch adhesive systems.~   "
23318|NCT02751957|"~     This Mentored Career Development Award will lay the foundation for a career focused on~     addressing 2 specific Grand Challenges in Global Mental Health priorities: 1) improving~     child access to evidence-based mental health care, and 2) reducing the duration of untreated~     illness by developing culturally-sensitive early interventions. The proposed research aims~     to assess the acceptability, feasibility, and impact of a brief caregiver-mediated early~     autism intervention adapted for use in a low resource setting. Data from this pilot study~     would inform scalable early autism intervention programs for implementation in underserved,~     low resource, and low-literacy populations globally.~   "
23319|NCT02751944|"~     This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell~     membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage~     turnover in healthy post-menopausal women. Half of the study participants will receive NEM,~     once daily, orally while the other half of the study participants will receive placebo, once~     daily, orally.~   "
23320|NCT02751931|"~     A study to evaluate the efficacy, safety and tolerability, and pharmacokinetics of~     mirabegron after multiple-dose administration in the pediatric population.~   "
23321|NCT02751918|"~     Anetumab ravtansine is developed for the treatment of patients with recurrent~     platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the~     maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated~     liposomal doxorubicin in this indication.~   "
23322|NCT02751905|"~     The primary objectives of the study are: To determine the mass balance and routes of~     elimination of BIIB074 and its known metabolites following administration of a single oral~     dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of~     BIIB074 and its known metabolites and the disposition profiles of total radioactivity in~     whole blood and plasma following a single oral dose. The secondary objectives of this study~     are: To assess the safety and tolerability of BIIB074 in healthy participants and To~     identify and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.~   "
23323|NCT02751892|"~     Long-term maintenance of physical activity behaviour change post-intervention remains~     challenging. This study is investigating the feasibility of a behaviour change intervention~     based on Self-Determination Theory in people recovering from colorectal cancer and its~     effects on behaviour change 6 months post-intervention.~   "
23324|NCT02751879|"~     This is a non-interventional, multi-country, multi-site study based on existing data from~     medical records of patients treated with Gi(l)otrif® as part of the routine treatment~     according to the approved label. Data from real-world will help to understand if dose~     modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and~     effectiveness are as in trial settings. Furthermore, data on modified starting doses, the~     underlying reasons and effects on safety and outcome are needed.~   "
23325|NCT02751866|"~     Nutritional intervention in overweight middle aged individuals with subjective memory~     complaints.~   "
23326|NCT02751853|"~     Aim of the study is to assess the effects of abruptly increased afterload on left~     ventricular contractility and relaxation in patients with heart failure with preserved~     ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction~     (HFREF), and patients without HFPEF or HFREF.~   "
23388|NCT02751034|"~     The purpose of this study is to compare the efficacy and safety of the study medical device,~     Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction~     of nasolabial folds~   "
23327|NCT02751840|"~     Background. The prevalence of obesity has increased in the last two decades. To maintain~     body weight energy expenditure (EE) should be equal to energy intake (EI). A low EE~     predisposes individuals to weight gain and to obesity that can also results from low resting~     metabolic rate (RMR). Caffeine (Caf) is an active food ingredient and is widely consumed~     globally, and has an important impact on energy balance. Caf reduces appetite (EI) and~     increases EE, thus, Caf has a potential role in body weight reduction. Caf causes higher~     total daily energy expenditure (TDEE) in normal weight (NW) people compared to obese (OW).~     Moreover Caf is linked to decreased fat oxidation in OW. There are differences between OW~     and NW in Caf pharmacokinetics, but no differences reported between NW and OW females in its~     effects on RMR. There is a gender difference in the influence of Caf on metabolism. The~     investigators are aware of no previous studies which compared the effect of Caf on the RMR~     of NW and OW men.~      Objectives. 1) To compare the effect of Caf and coffee on resting metabolic rate (RMR)~     values in healthy normal-weight (NW) men and overweight (OW) men. 2) To develop Caf intake~     frequency questionnaire (in Hebrew)~      Hypothesis. RMR values will be higher and respiratory exchange ratio (RER) values will be~     lower in NW compared to the values measured in OW men.~      Methods. 33 men (16 NW and 17 OW) were reported to the laboratory on 4 separate occasions~     (placebo, Caf tablets, coffee and decaffeinated coffee). During the lab sessions they were~     undergo complete anthropometric measurements and RMR measured (one of the study conditions)~     using indirect calorimetry. Additionally, respiratory exchange ratio (RER) which is~     calculated as the ratio between CO2 production (VCO2) and O2 consumption (VO2) (VCO2/VO2),~     blood pressure and heart rate (HR) response recorded.~      The importance of this study is that the results will contribute to the scientific basis of~     weight control and health interventions programs (diet and physical activity) in overweight~     men.~   "
23328|NCT02751827|"~     In order to assess the important issue of the safety of antiangiogenic TKI in geriatric~     population we set up this project which aims to identify, among clinical, biological,~     pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI~     (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 75 year-old.~   "
23329|NCT02751814|"~     Objective is to examine the physical activity and screen-time behaviors of children enrolled~     in licensed childcare centers before and after the enactment of new state regulations.~   "
23330|NCT02751801|"~     Hypophosphatasia (HPP) is a genetic disorder caused by mutation in the tissue-non-specific~     alkaline phosphatase gene (TNSALP). It causes impaired bone mineralisation, fractures, tooth~     loss, muscle weakness and possibly other adverse health outcomes.~      The infantile-onset forms are severe, and were often fatal until the recent availability of~     a treatment (Asfotase Alfa). The childhood-onset forms are less severe, and the adult-onset~     form is mild, and often unrecognised or misdiagnosed as osteoporosis.~      The less severe forms of the disease are not well described, and because there has been no~     available treatment there has not been much research in adults. However, now that treatment~     is available there is a possibility of a clinical trial in adults. To know whether there is~     a need for a trial there is a need to determine if there is a significant personal and~     economic burden associated with the less severe forms of HPP.~      The study consists of a clinical interview and notes review of adults and children with~     confirmed (by biochemical and genetic testing) HPP attending metabolic bone clinics in~     Sheffield to establish their clinical problems and healthcare use. There are currently about~     26 adults and 8 children attending clinics in Sheffield.~      The information will be used to plan a data search and health economic analysis of the~     burden of HPP from the UK Clinical Practice Research Database in collaboration with~     Pharmatelligence (a healthcare data group based within the University of Cardiff).~   "
23331|NCT02751788|"~     The goal of this project is to examine the physical activity and screen-time environment of~     licensed childcare centers before and after the enactment of new state regulations.~   "
23332|NCT02751775|"~     The objective is to establish community priorities for strategies to improve young~     children's health behaviors based on focus groups of stakeholders in the greater Baton Rouge~     area.~   "
23333|NCT02751762|"~     The purpose of this study is to quantify the serious risks of misuse, abuse, and addiction~     associated with long-term use of opioid analgesics for management of chronic pain, among~     patients prescribed ER/LA opioid products.~   "
23334|NCT02751749|"~     The study uses a replicated randomized single case design. Participants were 12 individuals~     with chronic pain problems and residual problems after undergoing a multimodal pain~     rehabilitation. They also had comorbid emotional problems. Treatment consisted of 10 weeks~     of Internet delivered, therapist guided CBT based self-help treatment based on the Unified~     Protocol.~   "
23335|NCT02751736|"~     The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy~     repair operation in patient with rectal cancer improve a bowel function.~   "
23336|NCT02751723|"~     The aim of this non-investigational study is to determine the symptoms and disease burden at~     the time point of diagnosis and in the further course of an incurable cancer disease. The~     needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer,~     malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer,~     cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by~     various validated questionnaires. The data obtained by these questionnaires are collected~     together with information obtained by the treating physicians at four time points during the~     study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor~     therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after~     patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative~     project offers the chance to identify medical services deficits and risk circumstances for~     the burden of treatments in an oncology-palliative setting and to optimize the quality of~     patient care.~   "
23337|NCT02751710|"~     This trial is being conducted to determine the impact of whole body FDG PET-CT vs.~     conventional staging in the management of patients presenting with clinical Stage III breast~     cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be~     randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting~     patients with lobular only histology will be entered into a separate single arm prospective~     study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen & pelvis~     and a bone scan.~   "
23338|NCT02751684|"~     The investigators want to identify and show differences in standards and procedures of~     in-hospital rapid sequence induction by collecting data with an online survey for~     anaesthetist in Europe.~   "
23425|NCT02750553|"~     This is a randomized, placebo-controlled, single & multiple dose escalation study to~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The~     study will be conducted with starting dose of 5 mg followed by dose escalation groups up to~     100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug~     or placebo.~   "
23339|NCT02751671|"~     Background:~      The investigators recently evaluated a new bladder stimulation technique to obtain~     clean-catch urine in infants aged less than six months. In this study, the reported success~     rate was of 52%. Measuring the transversal bladder diameter prior to the procedure with~     emergency point-of-care ultrasound (ePOCUS) could likely increase success rates for this~     technique as it has been described for bladder scans prior to performing urethral~     catheterization.~      Objective:~      The aim of this study is to evaluate if using emergency point-of-care ultrasound to measure~     bladder volume improves clean-catch urine collection success in patients less than 6 months~     of age when compared to children undergoing this technique without a prior ultrasound.~      Methods:~      This will be a randomized controlled trial performed in a tertiary paediatric emergency~     department. Participants will include all infants younger than 6 months of age who need a~     urinary culture and/or analysis requested by the attending physician. The intervention will~     consist of the use of emergency point-of-care ultrasound by a trained research assistant.~     The primary outcome will be the rate of success of the procedure. Secondary objectives will~     be to evaluate time to collect urine samples and to determine which transversal bladder~     diameter correlates with more than a 90% success rate for the procedure. Independent~     variables will be sex and age. In both groups, trained research nurses will collect~     clean-catch urine samples using bladder stimulation techniques. The success rate of the CCU~     procedure in both groups will be calculated. The time required to collect urine samples will~     be analysed. In group 1, the investigators will determine the transversal bladder diameter~     corresponding to a success rate for the procedure of > 80%. It is estimated that, in the~     worse-case scenario, the evaluation of 200 participants will provide a 95% confidence~     interval smaller than 10% for proportions. In addition, 20 participants with a successful~     CCU sample would allow to evaluate 2 risk factors using univariate and multivariate~     analysis.~      Expected results:~      This study will demonstrate that use of emergency point-of-care ultrasound increases success~     rates of stimulated clean-catch manoeuvres and may avoid invasive urethral catheterizations~     in young children.~   "
23340|NCT02751658|"~     The bacteria live in community and in some cases it is the combination of several~     microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome~     follows from this finding. Investigators hypothesize that the microbial community water~     point is a pathobiome influencing installation and transmission of pathogens associated with~     care~   "
23341|NCT02751645|"~     The investigators primary objective is to determine if acute normovolemic hemodilution (ANH)~     for pediatric cardiac surgical patients decreases the volume of blood products transfused~     during surgery and the immediate post-operative period as compared to usual care. This study~     will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing~     either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for~     the use of cardiopulmonary bypass.~   "
23342|NCT02751632|"~     A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a~     step-wise clinical approach for the treatment of ultra high risk patients and reduction of~     risk for psychosis and other deleterious clinical and/or functional outcomes.~   "
23343|NCT02751619|"~     Thoracotomy is one of the most painful surgical incision. Uncontrolled acute~     post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased~     the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and~     postoperative pulmonary infections. Thus, an effective analgesia is crucial in order to~     reduce perioperative morbidity and hospitalization time and also to prevent chronic~     post-thoracotomy pain.~      Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard~     strategies for thoracic surgery but the difficult of performing them in all patients and~     their potential complications are all factors that limit their use. Systemic administration~     of opioids is the simplest and common strategy to provide analgesia but it may be associated~     with several undesirable effects, such as respiratory depression, sedation, nausea,~     constipation and vomiting.~      In the recent years, preventive analgesia is become one of the most promising strategy of~     postoperative pain control. It is based on the concept of administering analgesic drugs~     before the occurrence of nociceptive input in order to prevent central sensitization. The~     efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on~     controlling pain after thoracic procedure.~      Pain following thoracotomy has a multifactorial genesis including surgical incision,~     intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of~     diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous~     locations could be more effective than a single strategy targeting one site along the pain~     pathway.~      Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the~     skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of~     systemic morphine analgesia for controlling post-operative pain following thoracotomy.~   "
23344|NCT02751606|"~     This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in~     combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.~   "
23345|NCT02751593|"~     The project was undertaking by Peking University People's Hospital and other well-known~     hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of~     ITP in pregnancy.~   "
23346|NCT02751580|"~     This pilot clinical trial studies how well telehealth works in patients during post~     radiation therapy visits. A telehealth virtual office visit can be performed from the~     patient's home or workplace, decreasing time spent traveling to visit site, time spent in~     waiting room, and cost to patient. Studying telehealth may improve quality of life in~     patients during post radiation therapy visit.~   "
23347|NCT02751567|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
23348|NCT02751554|"~     The purpose of this study is to help develop a special PET/CT scan to help the investigator~     to develop a new drug and see where this drug goes in the body and how long it stays in~     cancers and normal tissue. The drug is called PU-AD. In this study, the investigators will~     give a tiny dose of PU-AD, a dose which they expect to be much too small to affect the~     cancer. This tiny dose will be labeled with (attached to) a very small amount of radiation~     (called Iodine-124 or 124I) so that the investigators can follow where it goes in the body~     by using a PET/CT scanner. Doing this will help the investigators figure out how to best~     give higher doses of PU-AD to other patients in the future, and will help the investigators~     see if this tiny dose of PU-AD with radiation (124I-PU-AD) might be used in the future to~     detect tumors using a PET/CT scanner.~   "
23349|NCT02751541|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
23350|NCT02751528|"~     The purpose of this study is to determine whether ETBX-021 is safe and effective in the~     treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.~   "
23351|NCT02751515|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
23352|NCT02751502|"~     Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be~     randomized to receive either a bimanual-to-unimanual device home training program (10~     subjects) or a conventional non-device home training program (10 subjects) for a period of 6~     weeks.~      The specific aims of this proposal are to:~      Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from~     ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is~     hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will~     lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a~     conventional home training program.~      Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in~     the pediatric population with hemiplegia following ABI.~      It is hypothesized that individuals receiving device-based bimanual-to-unimanual training~     will show improvement in active range of motion across upper limb joints compared with a~     conventional home training program.~   "
23354|NCT02751476|"~     This study builds evidence on the importance of using safe drinking water during the~     nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following~     hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will~     reduce exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea~     incidence among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease~     will result in shorter recovery pe-riods for children with SAM. The study will evaluate the~     effectiveness of safe drinking water in reducing SAM treatment cost and duration and will~     provide recommendations for improving SAM treatment protocols.~   "
23355|NCT02751463|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
23356|NCT02751450|"~     This single centre, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice.~   "
23357|NCT02751437|"~     The investigators will explore the effect of current intravenous feeding (parenteral~     nutrition (PN)) formulations on blood arginine levels and the genes that are involved in~     body nutrition and fighting infection in premature babies. They will also investigate the~     effect of supplementing arginine on these genes. The investigators will undertake a single~     centre exploratory physiological study in 12 very premature infants receiving PN. 4 of these~     infants will be supplemented with arginine. The investigators will record nutritional intake~     and routine biochemical testing data (which includes amino acid levels) collected over the~     first 10 days of life. They will take blood for analysis at prespecified intervals for~     microarray, ammonia and IGF-1 levels. Microarray findings will allow the investigators to~     describe the effect of arginine on gene activity in preterm infants.~   "
23358|NCT02751424|"~     A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled,~     dose-escalation study is conducted to determine the safety, tolerability, and~     pharmacokinetic (PK) profile of GSK3342830 after administration of single intravenous (IV)~     infusion in Part 1 and repeat IV infusion in Part 2 in healthy subjects. Part 1 will~     investigate escalating single IV doses of GSK3342830. Part 2, will investigate escalating~     repeat IV doses of GSK3342830 with repeat dosing for 15 days as follows: a single IV~     infusion on Day 1, TID (three times a day) IV infusions on Days 2 through 14 (approximately~     every 8 hours), and a single IV infusion on Day 15. The planned starting GSK3342830 dose in~     Part 1 is 250 milligram (mg) administered as a single IV infusion. The dose is planned to~     increase in subsequent cohorts to 500, 1000, 2000, 4000, and less than or equal to (≤) 6000~     mg. Part 1 will be divided into 6 cohorts (A-F) and each cohort will enroll 10 subjects (6~     in active and 2 in placebo). Dose escalation will be conducted only if it is supported by~     the preliminary safety, tolerability, and PK results from the preceding dose levels in the~     study. The repeat dose escalation component (Part 2) of this study will be planned to be~     initiated after completion and evaluation of the all single dose cohorts up to and including~     4000 mg.~   "
23359|NCT02751411|"~     The trial intends to see how the two different products, the medical device in micro-enema~     and the drug given by mouth, act in giving the child regular evacuation after 1 week of~     daily use, 1 week of use every other day and 2 weeks of use as needed. The hypothesis is~     that the protective micro-enema will help to achieve regular evacuation by its local~     antinflammatory non pharmacological action. This hypothesis comes from the observation that~     local anal inflammation can cause functional constipation due to discomfort and pain during~     evacuation or by influencing reflexes.~   "
23360|NCT02751398|"~     This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2~     DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the~     impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic~     dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint~     is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on~     functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients~     at resting diastolic function. This is single-center, randomized, double-blind,~     placebo-controlled, parallel-arm intervention study.~      This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction~     assessed. The dose of dapagliflozin will be 10 mg as approved.~      For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was~     performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal~     exercise capacity were assessed before and after treatment. This study will be randomized,~     double blind, placebo controlled, to minimize the risk of bias.~   "
23361|NCT02751385|"~     Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a~     combination of ethinylestradiol and levonorgestrel (Microgynon®)~   "
23362|NCT02751372|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
23363|NCT02751359|"~     The purpose of this double-blind, placebo-controlled study is to determine the analgesic~     effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have~     intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor~     Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of~     analgesics.~   "
23364|NCT02751346|"~     This single-center, cross-sectional survey and sensory examination is conducted to determine~     the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent~     cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on~     data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of~     patients undergoing cystectomy will develop PPSP.~   "
23365|NCT02751333|"~     Esophageal stents are commonly used for benign esophageal pathology, especially strictures~     or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting~     factor to stent placement is the high migration rate of the stent. Investigators are trying~     to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign~     esophageal disease in comparison with standard, fully covered self-expanding metal stents~     (FCSEMS) placement without fixation.~   "
23458|NCT02750124|"~     The main purpose is to develop and test an IT-infrastructure to provide more individualized~     ways of inviting and reaching women who have not participated, despite having been invited~     with annual reminders, in cervix cancer screening program during a ten year period.~   "
23366|NCT02751320|"~     This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period~     crossover, incomplete block design, in situ caries study in healthy adults who wear a~     removable bilateral mandibular partial denture. The denture will be modified to accommodate~     4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously~     demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type~     will be used with each participant). After 14 days of twice daily product use off-site, the~     2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion~     specimens removed at the study site after a further 14 days of product use. To determine the~     remineralization ability of the treatments, all specimens will be analyzed by transverse~     microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally~     analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by~     quantitative light fluorescence (QLF).~   "
23367|NCT02751307|"~     Metformin has been used for alleviating metabolic abnormalities in patients with~     schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in~     clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a~     lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles~     in clozapine-treated patients with pre-existing metabolic abnormalities.~      Methods:~      In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or~     1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia~     having pre-existing metabolic abnormalities. The recruited patients underwent physical and~     laboratory evaluations at week-4, week-8, and week-12.~   "
23368|NCT02751294|"~     This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution~     profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets~     exhibiting different dissolution profiles in healthy subjects. This is a single-centre,~     2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will~     arrive in the unit approximately 24 hours prior to dosing and will be discharged after the~     72-hour post-dose assessments are completed. Subjects will return for outpatient visits on~     Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm)~     are planned to be enrolled. All subjects will receive a single dose of study medication~     (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose~     follow-up visit. To enable the application of peripheral microsampling in planned paediatric~     studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood~     collection (via microsampling) to venous collection will also be performed in this study.~   "
23369|NCT02751281|"~     The purpose of this study is to determine which type of percutaneous nephrolithotomy is~     better in large kidney stones~   "
23370|NCT02751268|"~     The purpose of this study is to determine whether bilateral infraorbital and infratrochlear~     nerve block in patients undergoing septorhinoplasty are effective in preventing emergence~     agitation.~   "
23371|NCT02751255|"~     Multiple myeloma (MM) patients who develop bortezomib and lenalidomide-resistant disease~     have a very poor survival of only a median of 9 months, indicating that new agents are~     urgently needed. Recent studies have shown that daratumumab as a single agent is effective~     and well tolerated in these heavily pretreated MM patients. However, approximately 60% of~     patients do not achieve a partial response, and ultimately all patients will develop~     progressive disease during daratumumab therapy.~      The investigators have demonstrated that levels of the target antigen CD38, and expression~     levels of the complement inhibitory proteins CD55 and CD59 determine the susceptibility of~     the MM cells towards daratumumab. In addition, MM cells have lower CD38 expression levels~     and higher levels of CD55/CD59 at the time of progression. Importantly, all-trans retinoic~     acid (ATRA) upregulates CD38 levels and downregulates CD55/CD59 levels on MM cells, both in~     daratumumab naïve cells and in cells that are resistant to daratumumab because of previous~     exposure to this drug. These alterations in expression explain the strong synergy between~     ATRA and daratumumab, both in MM cells derived from daratumumab naïve patients and from~     patients with daratumumab-refractory disease.~      These data form the preclinical rationale for clinical evaluation of ATRA and daratumumab in~     MM patients.~   "
23372|NCT02751242|"~     The study team hypothesizes patients at risk for diuretic resistance can be identified early~     in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and~     potassium concentration after an initial dose of IV loop diuretic. The goal of this pilot~     study is to prospectively study urinary electrolyte excretion and determine patterns of~     diuretic responsiveness. This study would be utilized to power an interventional study which~     aims to study alternative methods of treating patients who are identified as having a poor~     response to diuretics in the ED and hospital. This would be expected to have a significant~     impact on a patient's hospital course, length of stay and adverse events.~   "
23373|NCT02751229|"~     The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest~     Open Proud' among adolescents with mental illness.~   "
23374|NCT02751216|"~     This study is an interventional, observatory single center trial investigating the~     functional connectivity of the electrical brain activity in high frequency/high density~     spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.~   "
23389|NCT02751021|"~     Little is known about potential relationships between sleep apnea, plasma aldosterone and~     diastolic dysfunction which is a very frequent finding among patients requiring permanent~     cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation~     tests are expensive and access is limited. A specific algorithm available in a recent~     pacemaker allows assessing breathing variations using minute ventilation sensor, with a good~     agreement between the respiratory disturbance index and polysomnography results for the~     diagnosis of severe sleep apnea.~      The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm~     for the diagnosis of obstructive sleep apnea in patients presenting with diastolic~     dysfunction. The investigators also aim to highlight a correlation between plasma~     aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation~     therapy in this specific population.~   "
23459|NCT02750111|"~     Determine the incidence of hypoglycemia during / after sexual intercourse among young adults~     with type 1 diabetes using continuous -type sugar meter IPRO for a week.~   "
23375|NCT02751203|"~     Unintentional injury is the leading cause of death for young children in the United States~     (U.S.) and is responsible for more child deaths than they next three causes combined, that~     is, homicide, suicide, and cancer. Each year approximately 9,000 children die, 250,000 are~     hospitalized and more than 9,000,000 children are treated in emergency departments for~     preventable injuries. Child and adolescent unintentional injury deaths have not declined to~     the same extent that other diseases have, and resources directed at reducing child injury~     are not commensurate with the burden it poses. More than 50% of these injuries occur in and~     around the home, where young children spend most of their time.~      Unlike diseases such as cancer, there is no need to wait on a cure...there already is one.~     Many of these injuries can be prevented through the use of safety equipment and by following~     safety recommendations. Using known, effective countermeasures can prevent or reduce the~     consequences of a child being injured yet these devices are not routinely utilized. Barriers~     related to identifying hazards, finding credible information and recommendations, and~     obtaining the safety products best-suited to the features of your home make creating a safe~     home challenging for caregivers. Interventions for increasing home safety behaviors have~     ranged from educational materials, health care provider counseling, safety product~     distribution, hands-on experiential learning in a safety resource center--these have all~     been evaluated with varying degrees of effectiveness, however, wide-reaching interventions~     to reach large/substantial caregiver audiences, are needed. Offering tailored safety~     information on multiple topics via a single platform, combined with the ability to acquire~     safety devices, is a more efficient means to reach a large segment of the population and may~     help reduce the aforementioned barriers.~      Thus, there is an urgent need for mobile technologies to reduce barriers by helping parents~     identify injury hazards in their homes, consolidate credible injury prevention~     recommendations, organize information by room or feature, tailor by child age, facilitate~     the acquisition and installation of safety products, encourage and track progress, thereby~     increasing the likelihood that parents accomplish these important life-saving safety tasks.~   "
23376|NCT02751190|"~     In the present study the investigators aimed to investigate the relationship between~     surgical methods and chronic pain in over 20 000 patients who underwent groin hernia repair~     in Sweden~   "
23377|NCT02751177|"~     RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor~     receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping~     is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and~     BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™~     technique with those achieved using the standard genotyping techniques and formalin-fixed~     paraffin embedded samples.~   "
23378|NCT02751164|"~     A retrospective analysis of the Case Mix Programme database to evaluate the association~     between day and time of admission to critical care and acute hospital outcome for unplanned~     admissions to adult, general critical care units in England, Wales and Northern Ireland.~   "
23379|NCT02751151|"~     The study will draw patients from the Transplant Dermatology specialty clinic, where the~     investigators see organ transplant recipients (OTR) for regular screening and serve as a~     regional referral center for this population. Enrollment will be limited to 20 patients.~     Inclusion criteria are organ transplant recipients status, active immunosuppression for at~     least 5 years, and history of at least one NMSC.~   "
23380|NCT02751138|"~     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite~     intensive research efforts and a multimodal management that actually consists of surgery,~     radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the~     current observational study is to determine immune phenotypes in individual patients with~     GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor~     properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase~     (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data,~     such as progression free and overall survival, Karnofsky index (progression free survival~     (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes,~     biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages,~     myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could~     predict a positive response to specific immunological therapeutic strategies and select the~     individual therapeutic plan for an individual GBM patient.~   "
23381|NCT02751125|"~     This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges~     using biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an~     implant into the new bone in a prosthetically guided position.~   "
23382|NCT02751112|"~     This study is a proof of concept that will assess the Predictor's kit performances. The test~     will be performed by several technicians, in immunological laboratories of several sites in~     France.~      In this study, couples of donor / recipient in the frame of a graft of CSH will be~     included.~   "
23383|NCT02751099|"~     Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost~     universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated~     with life-threatening complications, including fractures and cardiovascular (CV) events.~     Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity.~     Still, bone disease persists after transplantation.~      The investigators hypothesize that bone-derived hormones can induce CV events in kidney~     transplanted patients. Therefore, early evaluation of the bone health is recommended, and~     prevention of its complications is required. Bone biopsy, an invasive and expensive method,~     is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for~     bone disease are necessary. Classical biochemical markers of bone formation and resorption~     have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor~     23 (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting~     CKD-associated bone and CV disease after transplantation.~      This study assesses the phenotype of bone disease after transplantation (given by bone~     histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate~     its performance predicting CKD-associated bone and CV disease.~   "
23384|NCT02751086|"~     The overall purpose is to develop and maintain a multi-institutional database comprising of~     information regarding surgical, clinical and oncological features of patients that will be~     treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent~     follow-up.~      The main objective is to compare the three surgical arms on surgical and clinical outcomes,~     as well as on the oncological follow-up.~   "
23385|NCT02751073|"~     The purpose of this study is to learn more about the microbes (bacteria) that live in the~     vagina and the bladder. The investigators are doing this research study to understand the~     relationship between microbes (the microbiome) and the occurrence of urinary tract infection~     following surgical removal of the uterus and pelvic organ prolapse repair. The investigators~     expect Lactobacillus and Gardnerella will be the dominant organisms for most women.~     Non-Lactobacillus dominant microbiome communities will be more common in women who~     ultimately develop postoperative urinary tract infection.~   "
23390|NCT02751008|"~     Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its~     prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to~     a poor bone health condition and thereby a risk of fracture increased. The aim of this study~     is to identify patients with risk factors for low bone mass and determine their Bone Mineral~     Density (amount of bone) by performing bone densitometry and compared with healthy~     population of the same characteristics. Also the investigators want to evaluate bone quality~     by application of Trabecular Bone Score to images obtained by densitometry. As secondary~     objectives the investigators intend to correlate the data with with clinical variables to~     identify the most important in bone health clinical factors. In addition to measuring bone~     quality and quantity demographic and clinical process related to bone quality base and~     variables will be collected.~   "
23391|NCT02750995|"~     The purpose of this phase I study is to investigate the combination of hypomethylating~     agents with experimental peptide vaccination against four selected tumor antigens, known to~     be upregulated in response to hypomethylating agents, in patients with high risk~     myelodysplastic syndrome and acute myeloid leukemia.~   "
23392|NCT02750982|"~     This is a prospective investigation of the effects of Laughter therapy (LT) on perceived~     stress, self-efficacy, mood and other wellness measures in people with the following~     neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury,~     Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord~     injury.~   "
23393|NCT02750969|"~     The investigators like to learn whether Lidoderm patch (lidocaine 5%) helps tinnitus~     patients.~      so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if~     other means of drug delivery (e.g lidocaine patch) help tinnitus.~      The investigators are going to compare 1 day of treatment with lidoderm patch cream Versus~     (VS.) tegaderm patch (containing no drug) in treating tinnitus patients.~   "
23394|NCT02750956|"~     The primer aim of the study was to determine serum and gingival crevicular fluid (GCF)~     endocan levels in periodontal diseases pathogenesis supported with vascular endothelial~     growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.~   "
23395|NCT02750943|"~     This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and~     baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in~     healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of~     a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control~     gingivitis and gingival bleeding following 12 weeks twice daily brushing, compared to a~     negative control dentifrice.~   "
23396|NCT02750930|"~     Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an~     adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and~     has been approved by the United States (US) Food and Drug Administration (FDA), the European~     Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single~     group, multicenter, extension study to Study 200952. This extension study will provide~     extended safety, tolerability and immunogenicity data for the albiglutide liquid drug~     product. This extension study will comprise 2 study periods: treatment (26 weeks) and~     post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part~     in this extension study.~   "
23397|NCT02750917|"~     The purpose of this study is to assess efficacy and safety of lornoxicam compared with that~     of etoricoxib after total knee replacement.~   "
23398|NCT02750904|"~     This purpose of the study is to develop and test a new website to help people who have~     bipolar disorder quit smoking.~   "
23399|NCT02750891|"~     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent~     and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.~   "
23400|NCT02750878|"~     The purpose of this study is to determine if addition of a handout to the standard consent~     process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve~     patients' understanding, recall and satisfaction with their procedure. The information~     provided in the handout will include the procedure details, the accompanying risks and~     benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the~     investigators is to improve and standardize the current process for surgical consent for~     patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators~     hypothesize that addition of a handout will improve patient's preoperative comprehension by~     an absolute value of 10% compared to the standard consent process. The investigators further~     hypothesize that the handout will improve patient satisfaction and recall of the surgical~     procedure details post operatively.~   "
23401|NCT02750865|"~     In this study the investigators will advance research on the development of easy to use~     technologies to empower patients. This is a scalable approach that has a significant~     potential to reduce suffering for palliative care patients and their caregivers. The~     investigators will adapt existing tested empathic conversational agents (ECA) for home-based~     cancer care management and inpatient bedside counseling to provide the following functions:~        1. medication counseling;~        2. physical activity promotion;~        3. symptom management and continual screening for adverse events; and~        4. alleviation of stress and anxiety~        5. spiritual needs assessment; and~        6. advanced care planning.~      Data from the system will be monitored by a health professional, who communicates with~     members of the patient's care team. In this project, this activity will include facilitating~     referral for palliative care services.~      The investigators will conduct pilot studies both at Boston Medical Center and at~     Northeastern University that will test system usability (Northeastern University and BMC) as~     well as interview burden (BMC only).~      The investigators will conduct a Randomized Control Trial (RCT) to evaluate the agent~     technology, comparing usual care (UC) versus usual care plus the agent (UC+ECA) for patients~     21 or older, with a life expectancy of < 1 year, from outpatient clinics at Boston Medical~     Center (BMC). Each subject will be enrolled along with a caregiver surrogate subject. In~     addition to baseline data collection, there will be monthly phone surveys for six months;~     intervention subjects will use the system for a six-month period of time. In addition, the~     investigators will conduct a randomized trial within the intervention group to compare~     subjects getting functions 1-4 (above) versus subjects getting the augmented intervention~     with all six functions. The intervention will include a nurse management interface to~     monitor clinical alerts generated by the system to stimulate interventions by the clinical~     staff.~   "
23402|NCT02750852|"~     Aim of these study is to create an algorithm, using data from patients that undergoing total~     hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.~   "
23403|NCT02750839|"~     Aim of the study is to analyze results of treatment of proximal humerus fractures with~     mini-invasive technique and plate fixation.~      In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray~     results will be statistically analyzed to evidence any connection between clinical outcomes~     and osteoporosis.~   "
23404|NCT02750826|"~     This randomized phase III trial studies whether weight loss in overweight and obese women~     may prevent breast cancer from coming back (recurrence). Previous studies have found that~     women who are overweight or obese when their breast cancer is found (diagnosed) have a~     greater risk of their breast cancer recurring, as compared to women who were thinner when~     their cancer was diagnosed. This study aims to test whether overweight or obese women who~     take part in a weight loss program after being diagnosed with breast cancer have a lower~     rate of cancer recurrence as compared to women who do not take part in the weight loss~     program. This study will help to show whether weight loss programs should be a part of~     breast cancer treatment.~   "
23405|NCT02750813|"~     The purpose of this study is to compare the lens fit characteristics, specifically lens~     centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact~     lenses.~   "
23406|NCT02750800|"~     This study aims at evaluate the effect of adalimumab with patient support program (PSP) on~     clinical, health economic, patient reported outcomes in patients with rheumatoid arthritis,~     ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative~     colitis in the routine clinical setting in Hungary.~   "
23407|NCT02750787|"~     The study is designed to observe the use of a peptide-based oral nutrition supplement in~     adults with chronic malabsorption or maldigestion who require supplemental nutrition as~     assessed by a clinician.~   "
23408|NCT02750774|"~     High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are~     associated with many unfavourable maternal and neonatal outcomes.~      Adherence to lifestyle recommendations could be a major determinant of the efficacy on~     preventing unfavorable outcomes, namely among overweight/obese women. Previous studies~     investigated adherence to specific dietary patterns and their effect on pregnancy outcomes;~     however, no study has investigated adherence among overweight/obese pregnant women and its~     effect on the onset of several maternal-neonatal outcomes.~      This study aimed to determine whether the prescription of a lifestyle program, consisting of~     a customized low-glycemic index (GI) diet and a physical activity program, in overweight and~     obese women could affect the occurrence LGA babies. It also aimed to determine whether this~     kind of prescription influences the adherence to healthier eating habits, and how this, in~     turn, can influence the occurrence LGA.~   "
23409|NCT02750761|"~     This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active~     metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a~     single IV (Part A) or oral suspension (Part B) administration to hospitalized participants~     ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4,~     respectively).~   "
23410|NCT02750748|"~     To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone~     compared to an intramuscular dose of naltrexone.~   "
23411|NCT02750735|"~     In the last few years, a new clinical entity has emerged which includes patients who~     consider themselves to be suffering from problems caused by wheat and/or gluten ingestion,~     even though they do not have celiac disease (CD) or wheat allergy. This clinical condition~     has been named non-celiac gluten sensitivity (NCGS), although in a recent article, the~     investigators suggested the term non-celiac wheat sensitivity (NCWS), because it is not~     known to date what component of wheat actually causes the symptoms. Nickel is the fourth~     most used metal and the most frequent cause of contact allergy in the industrialized world.~     As a natural element of the earth's crust small amounts are found in water, soil, and~     natural foods, especially plant ones. Nickel allergy not only affects the skin but also~     results in systemic manifestations. Systemic nickel allergy syndrome can have cutaneous~     (urticaria/angioedema, flares, itching), and/or gastrointestinal (meteorism, colic,~     diarrhoea) signs and symptoms. In this study, the investigators evaluated 1) the frequency~     of Nickel allergy and Systemic Nickel allergy syndrome in NCWS patients, and 2) the~     clinical, serological, and histological characteristics of NCWS patients with contact~     dermatitis Nickel positive in comparison to NCWS patients without contact dermatitis.~   "
23412|NCT02750722|"~     The investigators aim to compare a single bout of moderately intense cycling exercise~     incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling~     exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of~     the lungs in adult patients with cystic fibrosis.~      The investigators further aim to analyze the short-term variability of resting diffusion~     capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.~   "
23413|NCT02750709|"~     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)~     and Nitisinone 10 mg Tablets High Compritol (Test Product 2) are bioequivalent to the~     reference product Orfadin 10 mg capsules.~   "
23414|NCT02750696|"~     Aim: The aim of this study was to compare the analgesic efficacy of two combinations of~     opioid and non-opioid analgesics for acute periradicular abscesses.~      Methodology: This study included 24 patients who sought emergency care in a Brazilian dental~     school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral~     prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or~     Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus~     acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary~     6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.~   "
23415|NCT02750683|"~     Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension.~     Early infusion of NE was associated with a favorable clinical outcome in a large cohort of~     patients . When administered early, NE increases cardiac output (CO) in patients with septic~     shock . This effect was suggested to be mainly related to an increased cardiac preload via~     the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a~     positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On~     the one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic~     conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic~     receptors may occur relatively late and thus, might not be observed when NE is administered~     early. Our study was designed to examine the inotropic effects of NE when administered in~     the early phase of human septic shock~   "
23481|NCT02749825|"~     This research study looks at Testosterone levels in patients receiving Trelstar versus those~     receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer~     by the FDA.~   "
23416|NCT02750670|"~     This is a pilot study to determine the overall survival rate and toxicities of obinutuzumab~     given with GDP chemotherapy for relapsed or refractory CD20+ aggressive non-Hodgkin~     lymphoma. Patients who have CD20+ and progressed R-CHOP therapy will be enrolled into the~     study. About 30 patients are planned to be enrolled from Princess Margaret Cancer Centre.~      If the enrollment is very slow then additional site may be included. Patients will receive~     Obinutuzumab +GDP for 3 cycles intravenously. CT scan will be used to evaluate the response~     rate after cycle 2 and PET-CT will be used after cycle 3. Responders (complete metabolic~     response, partial metabolic response) should proceed to autologous stem cell transplant~     (ASCT). Patients who have progressed after three cycles or less are to have their protocol~     treatment discontinued, with subsequent treatment at investigator discretion. Patients will~     be followed up to 24 months from transplant done or last chemo. Mandatory tissue submission~     and optional tissue and blood submission are required for the correlative component of this~     study.~   "
23417|NCT02750657|"~     Researchers are looking for better ways of understanding and treating pancreatic cancer. The~     purpose of this study is to see how useful it is to look for changes and characteristics in~     your genes (molecules that contain instructions for the development and functioning of the~     cells) and the genes within the tumour. These characteristics may be useful in choosing~     treatments for patients in the future. Changes (mutations) in genes have been shown to be an~     important characteristic in cancers. Looking at differences in genes in patients with~     advanced pancreatic ductal adenocarcinomas and comparing this information with response to~     their initial chemotherapy treatment may help to learn which treatments may be better for~     certain patients after initial treatment.~   "
23418|NCT02750644|"~     Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial~     (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at~     high risk for open carotid endarterectomy (CEA) based on the available data from large~     randomized clinical trials. High risk has been defined as (1) patients with severe~     comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease~     involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial~     infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging~     anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid~     occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy). Several~     recent studies have called medical high-risk into question for CAS indication.~      The purpose of this study is to evaluate the safety and perioperative and long-term~     effectiveness in patients with significant carotid artery stenosis with high-risk criteria~     (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to~     patients with standard-surgical-risk features.~   "
23419|NCT02750631|"~     Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times~     ending at their desired sleep time. Beginning the morning following their Wake Night,~     patients sit in front of a bright light, continuing morning bright light and specified sleep~     time for six weeks with weekly visits measuring depressive symptoms.~   "
23420|NCT02750618|"~     UX023-CL205 is a multicenter, open-label, Phase 2 study in children from 1 to 4 years old~     with XLH to assess the safety, PD, and efficacy of KRN23 administered via subcutaneous (SC)~     injections every 2 weeks (Q2W) for a total of 64 weeks.~   "
23421|NCT02750605|"~     The purpose of this trial is to compare short- medium long-term results in treatment of PAD~     (peripheral arterial disease) in the crural arteries with either drug coated balloon or~     conventional balloons in a prospective , randomized, single center study~      Results will be defined as:~      Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization),~     Primary patency, Clinical success, Serious adverse events, and the patients will be~     followed-up for 1 years.~      Primary endpoints:~      Primary Patency at 12 months~      Secondary endpoints:~      Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse~     events, TLR (clinical driven),~   "
23422|NCT02750592|"~     Assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections~     up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal~     anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy~     and safety data will be used to support the registration of secukinumab in Japan for the~     treatment of active AS.~   "
23423|NCT02750579|"~     Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and~     high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces~     the rate of cardiovascular death and recurrent myocardial infarction in this clinical~     setting. The recommendation regarding the timing of intervention in this clinical setting is~     derived from old trials and has a weak level of evidence. In fact, there are no conclusive~     randomized trials in the contemporary era providing guidance on the optimal timing of~     intervention. In addition, the optimal timing of this critical intervention has not been~     studied since the development of new P2Y12-ADP receptor antagonists and the controversy~     surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before~     intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not~     well validated to date. In addition, the recent changes in the use of pretreatment with~     P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention.~      Based on these evidences, we hypothesize that with the current protocols of care without~     pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior~     to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST~     elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.~   "
23424|NCT02750566|"~     Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to~     manage and is among the most serious disabling neurological disorders. Physician awareness~     regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden~     of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on~     treatment methods that show universal success. This gap in treatment choices provides an~     opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual~     therapy that can be integrated to help treat post-concussive symptoms. Previous studies have~     shown that OMT can help resolve imbalance and tinnitus in elderly populations and case~     studies have shown that this manual therapy may assist in patient recovery. The~     investigators hypothesize that OMT will decrease return to play/work time, will show an~     improvement in balance, and will decrease concussion symptoms as compared to counseling.~   "
23426|NCT02750540|"~     DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to~     compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3~     formulations of a tenofovir (TFV) enema. The goal of the study is to identify the dose and~     osmolarity of a TFV enema for human immunodeficiency virus (HIV) pre-exposure prophylaxis~     (PrEP) which achieves the desired colonic mucosal mononuclear cells (MMC) tenofovir~     diphosphate (TFV-DP) target concentrations that have previously been shown to confer~     protection from HIV acquisition in men who have sex with men (MSM).~   "
23427|NCT02750527|"~     This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6~     years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9)~     routine check-ups and any voluntary visits to the pediatricians office.~   "
23428|NCT02750514|"~     The purpose of this study is to determine whether nivolumab in combination with other~     therapies is more effective than nivolumab alone in people with advanced lung cancer.~   "
23429|NCT02750501|"~     Protocol 0000498 is a multi center, open label study to evaluate the safety, tolerability~     and fat absorption of sustained Relizorb (immobilized lipase cartridge) use for patients~     with cystic fibrosis and exocrine pancreatic insufficiency who receive enteral tube feeding.~   "
23430|NCT02750488|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
23431|NCT02750475|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
23432|NCT02750462|"~     The aim of the trial is to compare immediate angiography in survivors of out of hospital~     cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization~     with respect to 30 day mortality.~      The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung~     (DZHK).~   "
23433|NCT02750449|"~     To evaluate the potential of a test material to produce a photo allergic response.~   "
23434|NCT02750436|"~     Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint~     pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch~     blocks. Outcomes examined will include performance times and success rates.~   "
23435|NCT02750423|"~     Investigators are seeking to learn how well different cooling temperatures along with~     different blood flow pathways to the brain reduce the risk of injury to the brain in~     participants planning to undergo elective aortic arch and hemiarch surgery. Participants~     will be randomized to receive a cerebral protection strategy of either: deep hypothermic~     circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic~     circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).~     Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests,~     MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow~     ups.~   "
23436|NCT02750410|"~     The main purpose of this study is to evaluate the efficacy and safety of combination therapy~     with dulaglutide and insulin in Japanese participants with type 2 diabetes.~   "
23437|NCT02750397|"~     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant~     from an HIV+ deceased donor will be followed to determine the safety and efficacy of this~     practice. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors~     will also be followed.~   "
23438|NCT02750384|"~     This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen,~     parallel group study in 42 subjects~   "
23439|NCT02750371|"~     Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It~     was observed that durable memory impairments could arise at irradiated patients if~     radiotherapy is applied on medial temporal lobes.~      However, results concerned studies of anterograde memory and none, this day, estimates the~     impact of radiotherapy on autobiographical memory which also involves hippocampus.~      The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation~     on autobiographical memory.~      Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for~     who radiotherapy is indicated will be recruited.~   "
23440|NCT02750358|"~     This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an~     androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+)~     triple negative breast cancer (TNBC).~   "
23441|NCT02750345|"~     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)~     and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are~     bioequivalent to the reference product Orfadin 10 mg hard capsules.~   "
23442|NCT02750332|"~     The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone~     10 mg Tablet, under fasting and fed conditions (food-effect).~   "
23443|NCT02750319|"~     This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone~     alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting~     >30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days~     after major thoracic surgery.~   "
23444|NCT02750306|"~     This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep~     in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that~     suvorexant is superior to placebo in improving insomnia as measured by change from baseline~     in polysomnography (PSG)-derived total sleep time (TST) at Week 4.~   "
23445|NCT02750293|"~     Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per~     day versus placebo for 4 months, with effects on cardiovascular risk factors as main~     endpoint~   "
23446|NCT02750280|"~     This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem®~     plus standard local wound care versus standard local wound care alone in the treatment of~     diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks~     and ulcer recurrence with a 2 year follow-up.~   "
23447|NCT02750267|"~     The overall aim of this proposed research is to determine the safety, feasibility and~     efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and~     night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple~     48 hours in an out-patient setting.~   "
33473|NCT02618928|"~     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ±~     ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices~     across France.~   "
23448|NCT02750254|"~     Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy~     for patients with hematologic malignancies including acute myeloid leukemia (AML),~     myelodysplastic syndrome (MDS), and acute lymphoblastic leukemia (ALL); however, human~     leukocyte antigen (HLA)-matched donor availability continues to be a major hurdle.~     Historically, HLA haploidentical donor hematopoietic cell transplantation (haplo-HCT) was~     associated with high incidences of graft rejection and excessive non-relapse mortality~     (NRM), but recent advances utilizing post-transplant cyclophosphamide (PT-Cy) have~     revolutionized haplo-HCT and the outcomes are now comparable to allo-HCT using more~     traditional HLA matched related and unrelated donors. However, graft-versus-host disease~     (GvHD) continues to be a problem and is associated with significant morbidity and mortality~     in allo-HCT patients including those who receive haplo-HCT on PT-Cy platform. The aim of~     this early phase study is to investigate the safety and overall efficacy of azacitidine in~     reducing the incidence and severity of GvHD when added to PT-Cy based haplo-HCT platform for~     patients with AML, ALL, or advanced MDS.~   "
23449|NCT02750241|"~     Breast cancer survivors, from diagnosis until the end of life, go through many transitions.~     One major transition is the significant decrease of physical activity immediately after~     diagnosis. Despite the known benefits of physical activity—speeding recovery time and~     reduced cancer recurrence risk—only 1 in 3 survivors met physical activity recommendations~     of 150 minutes of moderate-intensity activity per week. Physical activity interventions have~     shown effectiveness in helping breast cancer survivors increase physical activity during~     treatment, but limited evidence-based physical activity interventions have been incorporated~     into the clinic and community. To address this limitation, the investigators are partnering~     with the UTMB breast cancer support group to conduct a 12-week physical activity~     intervention, Pink Warrior.~      The goal of this study is to compare an intervention that uses active games versus an~     intervention uses pedometer to encourage physical activity such as walking within breast~     cancer survivors in active cancer treatment. The study will include breast cancer survivor~     between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical~     activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants~     will be randomized to participate in the support group using the active video game-based~     physical activity intervention (Wii and Xbox active games) or to participate in the existing~     UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators~     hypothesize that by engaging in active video gaming, breast cancer survivors will be~     motivated to initiate and maintain physical activity during treatment. This will ultimately~     increase functional capacity and prevent functional disability in breast cancer survivors.~   "
23450|NCT02750228|"~     The purpose of this study is to track post-discharge outcomes on prematurely born infants~     who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan~     to report on the spontaneous closure rate as well as the incidence of pulmonary and/or~     cardiac events in these infants. The goal is to identify risk factors associated with~     adverse outcomes in prematurely born infants who are sent home with a PDA.~   "
23451|NCT02750215|"~     This research study is studying capmatinib as a treatment for advanced non-small cell lung~     cancer with MET exon 14 skipping, where the participant has already received prior therapy~     with a MET inhibitor.~   "
23452|NCT02750202|"~     Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in~     South Africa. Medical and destructive therapy for small warts is generally very effective,~     however unique problems posed by large or extensive genital warts are not so easily solved~     and treatment of affected patients remains very challenging. Recurrences are common~     especially among immune-compromised women. This study will test whether giving the~     quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior~     to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment~     with HPV vaccine can play a role in the control of both malignant and benign HPV disease in~     women with and without HIV infection through stimulation of the antibody response. In~     addition, HPV types and other associated diseases will be studied in women receiving HPV~     vaccine and placebo.~   "
23453|NCT02750189|"~     The purpose of this study is to estimate a direct/indirect medical cost and to provide~     evidence establishing efficient strategies to reduce medical costs of COPD in Korea.~   "
23454|NCT02750176|"~     A single arm design will be used to assess the feasibility and preliminary efficacy of a~     closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of~     the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound~     images. 30 participants will be recruited for this study. The rehabilitation protocol will~     include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will~     include a total number of session between 12 and 24. The number of session included in stage~     2, will depend on the total number of session completed during stage 1. The total duration~     of both stages will 5 months.~   "
23455|NCT02750163|"~     Aim of this study is to evaluate the effect of paracetamol administration on the~     microcirculation, on the plasmatic levels of free hemoglobin and on the oxidative stress of~     septic patient with fever.~   "
23456|NCT02750150|"~     Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy~     is present in 40% of cases. It has a very early onset and this coagulopathy is associated~     with increased mortality. It must be detected and treated early, as illustrated by the~     military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma~     (FFP) requires a thawing step.The French army has encouraged the development of a~     freeze-dried plasma of innovative because viral inactivation and universal blood grouping,~     well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be~     administered after 6 minutes of reconstitution without the need for cross-matching.~     Nevertheless, its used is currently reserved for military purpose in overseas operations and~     needs to be evaluated for civil use. To this end, the investigators need to evaluate the~     impact on coagulopathy of an immediate availability of plasma.~   "
23457|NCT02750137|"~     Ametop was introduced into the formulary as it was deemed more efficacious for intravenous~     cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be~     higher compared to other studies. This lead to a prospective observational study to look at~     the incidence and severity of skin reactions following routine clinical application of~     Ametop.~   "
23460|NCT02750098|"~     Comparison of aqueous and plasma glucose level in diabetic patients~      High glucose concentrations in aqueous humor are thought to be related of diabetic ocular~     injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic~     glycation, oxidative stress and activation of polyol pathway. However, glucose~     concentrations in aqueous humor of diabetic patients was only examined in a few patients in~     the past.~      This study will compare glucose concentration in blood plasma and aqueous humor in diabetic~     patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also~     be examined. Correlation between these parameters will be analyzed.~   "
23461|NCT02750085|"~     This is an investigator-initiated, industry-funded, multi-centre, international study that~     will be carried out prospectively at hemophilia treatment centres across Canada and the~     Czech Republic with SickKids as the coordinating site. The study will use a central~     laboratory not directly affiliated with any of the participating sites. Enrollment target is~     50 participants, both adult and pediatric with severe hemophilia A receiving Advate, who~     will each complete a 2-point and 6-point pharmacokinetic (PK) sampling. The main aim is to~     compare the results of a 2 sample PK using clinically practical time points and myPKFiT™ (a~     web-based, population PK Bayesian tool) to a 6 sample population PK to determine whether the~     results obtained are in good agreement.~   "
23462|NCT02750072|"~     This study will investigate the incidence and severity of anterior knee pain comparing two~     different approaches to tibial nail fixation; Infrapatellar versus percutaneous~     semi-extended suprapatellar incisions. Half the patients will be randomized to the gold~     standard infrapatellar approach with the other half being randomized to treatment with the~     percutaneous semi-extended suprapatellar approach.~   "
23463|NCT02750059|"~     Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART~     alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune~     activation and trafficking of activated and HIV-infected cells to the central nervous system~     (CNS), and limiting establishment and persistence of the CNS reservoir of HIV.~      At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of~     telmisartan augmentation), the investigator expect subjects in the telmisartan group will~     have reduced levels of blood and CSF immune activation markers, reduced brain inflammation,~     lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance.~      Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node~     biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48~     weeks develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks.~      Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who~     are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this~     study.~      Number of subjects: 21~      Duration of follow-up: 72 weeks~      Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with~     telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in~     both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and~     neuropsychological testing and exam will be collected at baseline, week 48 and week 72.~     Inguinal lymph node biopsy is an optional procedure that will be offered at baseline and~     week 48.~   "
23464|NCT02750046|"~     RATIONALE: Collecting and storing bone samples from patients with osteoporotic and~     nonosteoporotic fracture to study a special vessel subtype in the laboratory may help~     surgeon learn more about the relationship between bone mineral density (BMD) and a special~     vessel subtype (type H vessel).~      PURPOSE: This research study is looking at changes of a special vessel subtype in bone~     samples from patients with osteoporotic and nonosteoporotic fracture.~   "
23465|NCT02750033|"~     The research team will develop an intraoperative handheld device for assessing surgical~     margins during Mohs surgery. The device technology is based on multimodal optical~     spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The~     researchers will first acquire proof of concept MMS measurements within the Mohs surgery~     suite immediately after surgical excision and prior to histological processing. MMS~     measurements will be acquired directly on the patient from the NMSC excision site. The final~     outcome of this study will result in the sensitivity and specificity of MMS compared to~     histopathology during Mohs surgery. These results will allow for the estimation of the~     potential benefit of an intraoperative margin assessment technique.~   "
23466|NCT02750020|"~     Current study is the fourth wave of the policy-related survey on tobacco control in Hong~     Kong. It aims to investigate the level of public support on current and future tobacco~     control measures and taxation policies and to address the timely impacts of smoke-free~     policies, substantiate public support on further tobacco control measures and assist COSH in~     shaping policy direction for government. In total, 5000 subjects will be randomly selected~     for a telephone interview. The subjects will be categorized into three groups, i.e. never~     smokers (1667), ex-smokers (1667) and current smokers (1667). They will be required to~     answer a questionnaire via telephone. All data shall be collected using a Computer Assisted~     Telephone Interview (CATI) system, which allows real-time data capture and consolidation.~     All interviews shall be conducted anonymously. Analysis of survey data will aim to identify~     current opinion on tobacco control policies and implications for future policies. Analyses~     will be controlled for confounding variables as required by stratification into sub-groups~     based on important pre-defined characteristics and/or by multivariate analysis. Comparison~     with past trends and, where possible, extrapolation of future trends will be explored.~     Weights will be applied to adjust for the sex and age of Hong Kong population, and to handle~     the over-sampling issues of current smokers. The data analysis will be conducted by~     statisticians.~   "
23467|NCT02750007|"~     This study is conducted in China. The aim of this trial is to assess the tolerability to~     HS-20004 with titration administration in type 2 diabetic patients.~   "
23468|NCT02749994|"~     A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design~     clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and~     rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.~   "
23469|NCT02749981|"~     Pharmacokinetics of cefazolin in children undergoing cardiac surgery.~   "
23470|NCT02749968|"~     This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall~     trauma.~   "
33474|NCT02618915|"~     A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in~     adult males with moderate/severe to severe hemophilia B.~   "
23471|NCT02749955|"~     This study evaluates the feasibility (reach, adoption, safety and implementation) and~     initial efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis~     (PS-PrEP) intervention versus phone based Pre-exposure Prophylaxis (PrEP) treatment at 3~     months post randomization among a sample of high risk individuals 18 - 35 years from~     clinic-based recruitment and internal referrals from social network based projects. The~     evaluation of the intervention will be used to strengthen routine department of public~     health services linkage to PrEP care.~   "
23472|NCT02749942|"~     Objective The objective of this study is to investigate if long-term ambulatory remote~     ischemic conditioning can improve symptoms and signs of peripheral arterial disease in~     patients with type 2 diabetes.~      Background Peripheral arterial disease (PAD) is a vast socioeconomic challenge in the~     community of diabetes patients, causing foot ulcers and lower extremity amputations. The~     main treatment option for the complication is operative revascularisation. Thus there is a~     need for new treatment modalities for diabetes patients with PAD.~      Remote ischemic conditioning (RIC) is at non-invasive non-pharmacological treatment which~     has been shown to attenuate tissue damage caused by ischemia e.g. in hearts subjected to~     ischemia. RIC treatment consists of brief repetitive periods of ischemia induced in an~     extremity e.g. an arm. Recent findings show that six week RIC treatment improves healing of~     diabetic foot ulcers, suggesting a possible effect on the underlying pathological causes of~     ulcers e.g. PAD.~      Hypothesis The investigators hypothesize that RIC treatment can improve markers of~     inflammation, vascular and neuronal function and the sense of empowerment in type 2 diabetes~     patients with reduced peripheral blood supply.~      Aim to conduct a single center double-blinded randomized placebo controlled study~     investigating the efficacy of home based 12-week RIC treatment on markers of vascular,~     neuronal function, inflammation and serum lipid composition in 40 type 2 diabetes patients~     from Steno Diabetes Center with non-critical PAD.~      to qualitatively investigate the experience of empowerment related to the use of Remote~     Ischemic Conditioning (RIC) treatment and the mechanisms affecting if and how participants~     take up the RIC treatment.~   "
23473|NCT02749929|"~     Approximately 15,000 persons in Norway suffer from a wrist fractures during a year, making~     it the most prevalent fracture in this country. Treated conservatively, a cast is used for~     4-6 weeks before removal. After discontinuation of the cast, physiotherapy is implemented to~     aid in improving range of motion and regaining function of the injured wrist. The pain after~     injury can affect the patient to a greater or lesser extent, and it is common to prescribe~     sick leave for shorter amounts of time after the injury.~      Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may~     reduce pain and swelling after acute trauma, and potentially promote healing. The aim of~     this study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks~     after injury.~   "
23474|NCT02749916|"~     This study aims to compare image-based characteristics of carotid walls between symptomatic~     side and the opposite side. The design of this study is phase IV, prospective observational~     study.~   "
23475|NCT02749903|"~     This study will test any good and bad effects of the study drug called enzalutamide.~     Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope~     to learn if the study drug will shrink the cancer by at least 30% compared to its present~     size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary~     gland cancer, but it has already been FDA-approved to treat other cancers.~   "
23476|NCT02749890|"~     Primary Objective:~      To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to~     Week 26 in patients with type 2 diabetes mellitus.~      Secondary Objective:~      To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs)~     over a 52 week treatment period in patients with type 2 diabetes mellitus.~   "
23477|NCT02749877|"~     Cancer survival comes at a price: pediatric cancer survivors have a high risk for a wide~     range of cognitive difficulties, particularly survivors of cancer involving the central~     nervous system (CNS, e.g., brain tumors [BT]) are prone to neurocognitive impairments in~     areas such as executive functions, working memory, attention, memory, visuospatial and motor~     skills, processing speed as well as language. The aim of this interdisciplinary longitudinal~     study is to extend empirical knowledge on training and transfer effects in children with a~     history of cancer. It is hypothesized that early cognitive and physical interventions affect~     the remediation of pediatric cancer survivors in terms of cognitive functions. These changes~     are further hypothesized to be associated with white matter changes.~   "
23478|NCT02749864|"~     The hypothesis of this investigation stresses that the current understanding of the~     prevalence of HCV infection in the general population and in different subgroups will serve~     to lay out medium- and long-term measures for action geared toward reducing the disease~     burden through preventive, research, screening and therapeutic measures.~      Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to~     analyze the associated factors. To analyze and infer different screening strategies for HCV~     infection based on the at-risk groups/cohorts of elevated prevalence detected.~   "
23479|NCT02749851|"~     The purpose of this study is to test the application of newly generated magnetic resonance~     imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The~     primary objective is to validate and establish the utility of placental MRI in pregnant~     women. The study will be entirely MRI-technology based with collection of placental tissue~     at the time of infant delivery for later correlative studies.~   "
23480|NCT02749838|"~     Purpose of the Protocol:~        -  To prospectively identify cancer patients whose tumors express specific molecular~          markers targeted by therapeutic agents, for the purpose of selecting the most~          clinically appropriate anticancer therapy, including clinical trial opportunities.~        -  To collect and analyze biospecimens from cancer patients, using primarily standard of~          care laboratory methods, for the purpose of determining the expression of specific~          genotypic and phenotypic disease markers of scientific and medical interest.~        -  To create a protocol database, including case and disease stage-matched clinical and~          therapeutic history data in addition to patient biomarker profiles, to serve as:~             -  a systematic collection of data for comparing patient data to clinical trial~               selection criteria for the purpose of informing a clinical investigative site of~               available clinical trials matching patient clinical status;~             -  a collection of clinically matched, comprehensive molecular results for scientific~               and research and development applications.~   "
23482|NCT02749812|"~     The investigators propose a multicentric controlled randomized trial whose goal is to~     evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous~     positive airway pressure) and constant CPAP (constant positive airway pressure) in 800~     severe obstructive sleep apnea syndrome (OSAS) patients according to their profile of~     pressure variability.~   "
23483|NCT02749799|"~     The purpose of this study is to assess patient satisfaction when DFD-01 is used topically~     twice a day for moderate plaque psoriasis.~   "
23484|NCT02749786|"~     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the~     facial skin and ocular surface. It it considered to be a syndrome encompassing various~     combinations of cutaneous signs including flushing, erythema, telangiectasia, papules,~     edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown~     but is characterized by persistent vasodilation, increased vascular permeability, and~     vascular hyper-reactivity of the microcirculation of the central part of the face. The~     purpose of this study is to develop gene expression profiles of papulopustular rosacea~     compared to those of normal skin. The investigator hopes to better understand the abnormal~     gene functions that might contribute to this condition. This understanding may lead to the~     development of additional and better treatments for rosacea.~   "
23485|NCT02749773|"~     The aim of this study is to determine whether different needle gauges influences the quality~     of the aspirated oocytes during in-vivo fertilization (IVF).~   "
23486|NCT02749760|"~     This is a study of the muscle stabilizers of the elbow with respect to the prevention of~     Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring~     training and end of season for approximately 5 years. Pronator, flexor digitoum~     superficialis (FDS), and wrist flexion strength will be measured and correlated with upper~     extremity injuries and time missed from pitching. The investigators will also be measuring~     loss of strength over the season. The goal is to learn whether strength in these muscles~     prevents UCL injuries and finally whether these muscles can be strengthened to avoid such~     injuries.~   "
23487|NCT02749747|"~     -  Introduction: Estrogen hormonal therapy associated or not with progestagen is the~          standard therapy for the treatment of hot flushes. However some women are not~          candidates for hormone replacement therapy for medical reasons or for choice.~        -  Main goal: Reducing the number of hot flushes per week~        -  Materials and Methods: A double-blind sulpiride versus placebo that includes selected~          randomized patients which show symptoms of menopause. Study conducted at Hospital de~          Clínicas de Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a~          significant reduction in the number of hot flushes / day evaluated by daily~          questionnaires~   "
23488|NCT02749734|"~     The purpose of this study was to determine the safety and therapeutic effect of sub-retinal~     transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in~     patients with macular degeneration diseases, and explore new treatment modalities for~     macular degeneration diseases (Age-related macular degeneration and Stargardt's macular~     dystrophy).~   "
23489|NCT02749721|"~     The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes~     from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD)~     and 2) improvement of cognitive dysfunction with acute treatment with flexible dose~     vortioxetine in adult outpatients with MDD and subjective complaints of cognitive~     dysfunction.~   "
23490|NCT02749708|"~     The purpose of this study is to evaluate the use of IRX5183 in 1) patients with relapsed~     and/or refractory AML and 2) patients with high-risk MDS or chronic myelomonocytic leukemia~     (CMML).~   "
23491|NCT02749695|"~     The placental drug Melsmon® is effective for correction of insomnia and other climacteric~     symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and~     Placebo, but it was more significant in patients who used Melsmon®.~   "
23492|NCT02749682|"~     The purpose of this study is to asses the effect of chronic constipation on formation of~     inguinal hernia using Constipation Severity Scale.~   "
23493|NCT02749669|"~     For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the~     emergency unit. They are described as inappropriate hospitalization because they don't~     require the use of technical platform or diagnostic neither therapeutic procedures under~     medical supervision. Those are inappropriate because the patient could have a paramedical~     and social care at home or in more efficient structures. The hospital remains the place of~     remedy for social and health situations whose resolution was not possible because of a lack~     of infrastructure available, of patient or his relative information, or a lack of~     coordination in medico-social establishment.~      These inappropriate hospitalizations involve an increase of length of stay that enhancing~     the fragility and vulnerability of the elderly. They have deleterious effects as~     decompensation, comorbidities and loss of autonomy.~      Moreover, the suffering of natural or informal caregivers is also an important public health~     question; Caregivers may have a serious disease resulting from caring their relative. That~     leads to increase their consumption of health care and medical goods.~      This comprehensive study will highlight the deficiencies of the actual health care through~     the analysis of the speech of the different parts involved (main study). Simultaneously, a~     comparative analysis of the costs of health care will be conducted (economic combined~     study).~   "
23494|NCT02749656|"~     The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream~     (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp~     psoriasis.~   "
23495|NCT02749643|"~     Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on~     functional outcome measures of upper limb prosthetic users.~   "
23496|NCT02749630|"~     This study is a randomized, observer-blinded, placebo-controlled study to evaluate safety,~     tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV)~     UTTR1147A. The study will consist of a repeat dose escalation in healthy volunteers (HV) and~     a repeat dose escalation in Ulcerative Colitis (UC) patients across multiple sites.~   "
23560|NCT02748798|"~     The goal of this research is to optimize the MRI system to obtain ideal lung images using~     Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned~     to the frequencies of these gases will be used. This study will take place at TBRHSC in the~     Cardiorespiratory Department and in the Research MRI facility.~   "
23497|NCT02749617|"~     This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in~     participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a~     prospective, cohort study of 24 participants with multiple myeloma, in whom a~     lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible~     participants will initiate thromboprophylaxis with apixaban prior to starting their~     DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and~     plasma drug concentration will be measured.~      This pilot study looks to investigate this potential interaction between apixaban and~     dexamethasone to see if it warrants further investigation in a larger study.~      The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in~     peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban~     levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month~     treatment period.~   "
23498|NCT02749604|"~     GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for~     benign prostate enlargment and the emergence of ejaculatory sparing techniques made it~     feasible to get both benefits: relief of lower urinary tract symptoms and preservation of~     ejaculation. However evaluation of actual infravesical de-obstruction following such~     techniques remains a grey zone in the literature without an objective assessment of the~     degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different~     domains of the sexual function using comprehensive assessment tools was not compared in~     ejaculatory sparring vs. non-ejaculatory sparring approaches.~   "
23499|NCT02749591|"~     The aim of this study will be to determine and compare the immediate and longer-term effects~     of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and~     robot-assisted therapy.~   "
23500|NCT02749578|"~     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of~     atorvastatin in healthy male subjects and female subjects not of child-bearing potential.~   "
23501|NCT02749565|"~     The investigators will compare the circulating fibrocyte proportion in asthmatic patients~     with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will~     compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor~     (ETAR) and connective tissue growth factor (CTGF) The association of those factors and~     annual decline of forced expiratory volume in 1 second (FEV1) will be performed~   "
23502|NCT02749552|"~     Obesity is a prevalent, destructive, and costly chronic disease. In 2008, 37% of Canadian~     adults were measured as overweight, and 25% as obese. Obesity is a risk factor for a number~     of serious health problems, including type 2 diabetes, asthma, gallbladder disease,~     osteoarthritis, chronic back pain, several types of cancers (i.e., colorectal, kidney,~     breast, endometrial, ovarian and pancreatic cancers) and cardiovascular disease (i.e.,~     hypertension, stroke, congestive heart failure and coronary artery disease). In 2008, it was~     estimated that the annual economic burden of obesity in Canada was $4.6 billion. Given the~     economic strain and widespread health risks of obesity, there is a clear need to provide~     effective interventions for obesity.~      The purpose of the proposed study is to examine the role of ACT-based interventions in~     long-term weight maintenance. The proposed study will examine the role of value consistent~     behaviour, acceptance skills, and mindfulness skills in promoting long-term weight-related~     health behaviours. Acceptance and Commitment Therapy (ACT) is an empirically supported~     psychological intervention that emphasizes value consistent behaviours, acceptance skills~     and mindfulness skills.~   "
23503|NCT02749539|"~     Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder~     problems.~   "
23504|NCT02749526|"~     Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC~     neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.~   "
23505|NCT02749513|"~     The purpose of this study is to demonstrate that orally administered itraconazole, a~     commonly used antifungal medication, can inhibit Hedgehog pathway signaling in patients with~     esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).~   "
23506|NCT02749500|"~     The purpose of this study is to test the hypothesis that early independent adaptive~     bimanual-to-unimanual training of arm and hand movements, assisted with specially designed~     mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor~     control and function in patients with post-stroke hemiparesis.~   "
23507|NCT02749487|"~     Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status~     . It is a cost effective and readily available , and simply calculated , so that why~     investigators try to use it as a predictor of short term survival in the critically ill~     patients~   "
23508|NCT02749474|"~     The objective of this study is to follow the treatment options offered to pregnant women~     diagnosed with cancer and study the impact that their treatment or delay of treatment has on~     their own health and that of their children.~   "
23509|NCT02749461|"~     The aims of this validation study are the testing of the Bernese Pain Scale for Neonates'~     (BPSN) psychometric properties. The variability of pain reactions related to behavioral and~     physiological patterns across time will also be examined. Furthermore, the influence of~     contextual factors on the variability of pain reactions across gestational age groups will~     be explored. The results will be used for modifications of the BPSN to account for~     contextual factors in future clinical pain assessment in neonates.~   "
23521|NCT02749305|"~     This qualitative study will identify which domains are most important to metabolic and~     bariatric surgical patients, their families/partners, and their caregivers and which valid~     patient-reported outcome measures (PROMs) will best capture this information. Patient and~     caregiver feedback will be gathered on the local, regional, and national implementation~     PROMs in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program~     (MBSAQIP) as well as on patient-reported results and data presentation.~   "
23522|NCT02749292|"~     The purpose of this study is to determine the best management strategy to maintain remission~     in patients with ANCA vasculitis who have been treated with rituximab induced B cell~     depletion for at least two years. This study will compare intermittent B Cell depletion upon~     B cell return or intermittent B cell depletion upon serologic relapse.~   "
23561|NCT02748785|"~     To investigate whether a short term discontinuation of methotrexate (MTX) will improve the~     vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease~     activity in a randomized clinical trial.~   "
23510|NCT02749448|"~     Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs,~     especially lung tissue. SM exposure leads to serious changes in morphological structure of~     airway system, which is associated with chronic obstructive pulmonary deficiency following~     exposure to SM. With extensive progress and achievements in tissue repair through stem cells~     therapy, consideration of lung tissue has been increased due to the high prevalence of~     pulmonary problems. Several factors such as selection of cell types, required conditions for~     growth and proliferation of stem cells, and the process of entering into the body to repair~     damaged lung tissue are considered as the most important problems in this issue.~     Accumulating studies, both in animals and human with mesenchymal stem cells (MSC) support~     the hypothesis of therapeutic effects of these cells in various disorders. In this study~     investigators aimed to evaluate safety and potential efficacy of systemic MSC administration~     for treatment of chronic lung injuries in SM-exposed patients.~      Methods: Patients will receive 100 million MSC cells every two months for three injections~     within 6 months. After each injection, parameters including safety, pulmonary function~     testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of~     inflammation and oxidative stress genes will be evaluated.~   "
23511|NCT02749435|"~     A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to~     evaluate if the provision of a digital disease management tool improves glycaemic control in~     participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to~     End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for~     this study will be conducted as part of normal, standard care. The main objective of this~     study is to evaluate the effect of adding this tool to participants' current standard care~     for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood~     pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction~     with treatment and adherence to their antihyperglycaemic treatment~   "
23512|NCT02749422|"~     This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility~     and explore the neurophysiologic and clinical effects of repetitive transcranial magnetic~     stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of~     a control group will be used to see whether epilepsy patients, who suffer from a higher~     degree of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can~     benefit from a TMS intervention can benefit as much as a healthy matched population.~     Investigators will also be looking at functional connectivity between the hippocampus and~     cortical regions~   "
23513|NCT02749409|"~     Patients diagnosed traumatic rib fracture and need admission will be included. Patients will~     be divided two groups.The experimental group will be given parecoxib after visiting~     emergency department. The control group will be given Narcotic agent such as morphine for~     pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay~     will be recorded.~   "
23514|NCT02749396|"~     Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult~     females in their childbearing ages. Little evidence is available regarding the association~     between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four~     marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry.~     Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a~     study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β~     products for comparison with the ongoing European IFN-β Pregnancy Registry.~   "
23515|NCT02749383|"~     This study is a Phase II, single center, randomized, double-blind, placebo-controlled study~     in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of~     the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle~     for up to 4 weeks.~   "
23516|NCT02749370|"~     evaluate the efficacy of etanercept in adult subjects with moderate to severe plaque who~     have failed therapy with apremilast (Otezla)~   "
23517|NCT02749357|"~     INTRODUCTION:~      The ability to move and transfer own body in an effective manner, is frequently affected in~     people with a spinal cord injury with a negative impact in mood and quality of life, in such~     a way, that achieving an effective locomotion, is one of the main objectives in the~     rehabilitation program in a spinal cord injured patient.~      There are different modalities of locomotion training in spinal cord injury, being the~     robotic orthosis among them, and offering until now, positive outcomes. However there´s~     still a lack of evidence of the optimal training characteristics, in order to establish the~     best time, number of sessions, and progression scheme. For these reasons, establishing the~     effects of different locomotion training programs will provide the necessary data in order~     to develop an effective training program for the maximum benefit of the patient.~      OBJECTIVE To determine the effect of different training programs with robotic gait orthosis~     for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury~     Association Impairment Scale (AIS) C / D) in short and long term.~      METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the~     observer, clinical trial.~      Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C~     and D, with at least 6 months of evolution, and who are able to walk with or without gait~     auxiliary, will be eligible.~      Informed consent will be obtained from all subjects prior to participation. Patients will be~     randomly assigned to either one of the two different training groups: intervention or~     control group.~      The control group will be submitted to training sessions of 30 minutes, and the intervention~     group will have training sessions of 60 minutes.~      Both groups will receive a training period of six weeks, five days a week.~      Throughout the training period, gait assessments with the GaitRite instrument, will be~     performed, and repeated at 6 and 12 months after completion of the training as part of~     follow up. The data obtained from the GaitRite will be compared within each group, in order~     to determine which type of training is more effective~      Statistical analysis will be performed using SPSS, considering all P < 0.05 as statistically~     significant.~   "
23518|NCT02749344|"~     This is a pilot study of a novel protocol for preparation of the endometrium for~     frozen/thawed embryo transfer whereby estrogen is not administered during the proliferative~     phase and progesterone is administered through vaginal suppositories in accordance with~     endometrial thickness only, disregarding the day of ovulation. Progesterone supplementation~     commences once the endometrium is at least 7 mm, a follicle is demonstrated on TVS, and~     ovulation has not yet taken place. The day of ET is scheduled according to the unit's~     working days and progesterone suppositories are commenced 48 hours before the scheduled~     embryo transfer.~   "
23519|NCT02749331|"~     An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the~     safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic~     neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.~   "
23520|NCT02749318|"~     This is a pilot study to determine whether knowledge gained by an individual of genetic risk~     for severe periodontitis changes the patient's health behavior as measured by an increased~     frequency of their preventive dental office visits. In addition to the primary objectives of~     the study, the overall design and logistics will be used to inform a possible future study.~   "
23523|NCT02749279|"~     The most important drugs for evidence based lipid lowering treatment (LLT) in CHD are~     statins. All patients with established CHD should be treated with statins irrespective of~     low density lipoprotein (LDL) cholesterol (LDL-C) levels. The goals of treatment are LDL-C~     below 1.8 mmol/L (70 mg/dL) or 50% LDL-C reduction when target level cannot be reached.~     Unfortunately, several patients cannot achieve treatment targets also related to the serious~     problem of adherence to therapy, which includes also LLT.~   "
23524|NCT02749266|"~     The purpose of this pilot study will be to assess the impact of chiropractic Activator~     adjustments on spatial cognitive abilities through initial assessment and testing in a~     healthy population aged 18 to 35.~   "
23525|NCT02749253|"~     This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY)~     program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of~     trauma experience.~      SKY incorporates standardized collection of breathing techniques which are known to~     positively influence the autonomic nervous system and stress response system. Both these~     systems are dysregulated in PTSD.~   "
23526|NCT02749240|"~     At risk youth face various adversities including homelessness, social isolation, substance~     abuse and other mental illnesses. Thus far, the investigators have successfully partnered on~     programs of housing, social and recreational interventions in this population. The~     investigators now wish to assess the feasibility of delivery of an innovative~     bio-psycho-social intervention, Youth Empowerment Seminar (YES!), developed by their~     partner, the not-for-profit Art of Living Foundation. Therefore, the aim of this research is~     to conduct a proof of concept study to determine the feasibility of a novel YES! program as~     an intervention for at risk youth.~   "
23527|NCT02749227|"~     This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph~     pituitary tumors testing the hypotheses that Pasireotide LAR (long-acting release) treatment~     of patients with silent corticotroph pituitary tumors and elevated plasma~     Proopiomelanocortin (POMC) levels will reduce plasma POMC levels and this will be associated~     with a reduction in pituitary tumor size. Pasireotide LAR 40 mg will be administered~     monthly. Baseline and monthly visits on therapy will monitor plasma levels of POMC, other~     pituitary function, safety labs, glucose tolerance, physical examination, and visual fields.~     Pituitary magnetic resonance imaging (MRI) will be done at baseline, 6 months and 12 months~     of therapy. The eligible patient population will consist of adult patients with known silent~     corticotroph pituitary tumors and elevated plasma levels of POMC.~   "
23528|NCT02749214|"~     The purpose of this study is to determine the potential for a Parkinson's Disease (PD)~     -specific breath signature as a non-invasive screening tool for identifying PD patients with~     inflammation, tracking the progression of disease, and responsiveness to various therapeutic~     interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological~     disorders include any disorder involving the brain or the nervous system, for example memory~     disorders, stroke, movement disorders and many other conditions.~      The study will lay the foundation for future studies in which breath fingerprinting could be~     used as a screening technique. Investigators will also be looking at how the breath~     fingerprint correlates with inflammatory proteins in the blood.~   "
23529|NCT02749201|"~     To assess gastric wall thickness using transmitted light intensity.~   "
23530|NCT02749188|"~     The urinary tract infections are common in children. It is estimated that about 3% of girls~     and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt~     diagnosis and treatment are necessary for the prevention of morbidity and long-term~     sequelae.~      Currently, there are different methods of urine collection, such as suprapubic aspiration,~     the survey, the collection bag and the jet medium collection.~      They have in common to be time-consuming, invasive in some cases, providers of contaminated~     levies for others and impossible in children incontinent for the last.~      A Spanish study developed a new collection technique, for kidney and bladder stimulation,~     noninvasive, in the new-born to 30-day months. The results are promising with a success rate~     of over 85% within a period of about 45s.~      No study has looked at a broader pediatric population, including children from birth to age~     of acquisition of walking.~      We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in~     infants who have not acquired the works for which a urine sample is required.~   "
23531|NCT02749175|"~     Cricoid force is applied during airway management to prevent pulmonary aspiration of~     regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia~     assistant. Currently this is performed WITHOUT monitoring and the force applied is~     determined by the individual's educated hand that is derived from his/her experience from~     past training and practice. Studies have shown that the actual force applied by nurse and~     anaesthesia assistant is inconsistent and deviates from the optimal force. Under application~     of cricoid force results in ineffective cricoid pressure and the risk of pulmonary~     aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia,~     long Intensive Care Unit stay and even death. Over exertion of cricoid force results in~     distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion~     and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation~     crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses~     on manikin with and without direct feedback. Nurses were instructed to apply a range of~     force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load~     sensor was used. Unblinded nurses performed significantly better with feedback using the~     load sensor then blinded nurses. With Funding from a National grant, a real-time measurement~     of cricoid force is developed to give feedback and guide the operator to exert and maintain~     the TARGET cricoid pressure during rapid sequence induction (RSI).~      In this study we aim to verify the sensor system with a manikin and compare the forces~     applied by nurses with the sensor system and without.~   "
23532|NCT02749162|"~     The effect of perineural dexamethasone administered as an adjuvant in prolonging the~     duration of analgesia continues to be under debate. The investigators performed a~     prospective randomized study to evaluate the effect of perineural dexamethasone in different~     concentrations in postoperative analgesia in femoral nerve block for anterior cruciate~     ligament reconstruction.~   "
23533|NCT02749149|"~     This study will assess the benefit in using a frailty score to quantify accurate risk~     pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity~     and disability-free survival post-operatively.~   "
23536|NCT02749110|"~     This study evaluates the benefit in women aged from 30 to 65 years, who do not participate~     to the French opportunistic cervical cancer screening program, of an organized screening~     with the proposition by the family physician of a pap-test (usual care) versus a~     self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and~     will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our~     hypothesis is that organizing the screening for these women involving their family physician~     will major participation, and that the self-sampling option will amplify this increase.~   "
23537|NCT02749097|"~     This is a randomized, placebo-controlled, single dose escalation study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be~     conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight~     subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or~     placebo.~   "
23538|NCT02749084|"~     This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS.~      The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED~     LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC~     HEMATOPOIETIC STEM CELL TRANSPLANTATION.~      The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the~     following chapter.~      The primary objective of the dose escalation study will be SAFETY, leading to the definition~     of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL~     RESPONSE RATE at three months after the 3rd Treg infusion.~      The study is single center single arm open label and includes a DOSE ESCALATION phase~     followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD).~      The aim of the study is to assess whether multiple infusions of donor-derived purified T~     regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and~     whether it may induce clinical remission of GVHD.~   "
23539|NCT02749071|"~     The purpose of this investigation is to demonstrate the safety and effectiveness of Lower~     Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease~     (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled~     study. After the implant procedure, subjects will be randomized to either the Treatment~     Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed~     by an additional open-label phase in which all subjects will receive electrical stimulation.~     Subjects continue on stimulation treatment in an extended open-label follow-up phase through~     5 years post-stimulation.~   "
23540|NCT02749058|"~     The purpose of our study is to evaluate the differences in functional activities and~     proprioception after surgery in subjects who underwent hip prosthesis implant with~     capsulotomy or capsulectomy.~   "
23541|NCT02749045|"~     The overall purpose of this research study is to identify the disparity in ischemia~     measurement between fractional flow reserve (FFR) used in the cardiac catheterization~     laboratory and myocardial perfusion stress- single-photon emission computed tomography~     (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT~     obtained using regadenoson in the catheterization laboratory.~   "
23542|NCT02749032|"~     The present study is a phase I, single-centre, double-blind, randomized, cross-over (3~     treatments, 3 treatment periods and 6 sequences), stratified (background medication:~     metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on~     treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out~     periods between treatment periods lasting 21 days minimum.~      The study was designed to directly compare the effects of vildagliptin and sitagliptin on~     incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses~     in patients with type 2 diabetes.~   "
23543|NCT02749019|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in~     breast cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will~     be injected intravenously. Visual and semiquantitative method will be used to assess the~     PET/CT images.~   "
23544|NCT02749006|"~     Bipolar-I Disorder is a common condition that is characterized by periods of mood elevation~     however periods of chronic and recurring depressive episodes are more common and can be~     severely disabling. Effective treatments exist, however a significant portion of bipolar~     depressed patients do not respond to, or have difficulty tolerating many of these~     interventions. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive~     neuromodulatory technique that is effective in major depression and there is evidence for~     its efficacy in bipolar depression which needs to be assessed in larger randomized~     controlled trials. This study is a randomised, double-blind, sham-controlled trial over four~     weeks. The primary objective is to assess improvement in depressive symptoms in acute~     bipolar-I depressed patients on treatment with intermittent Theta-Burst Stimulation (iTBS)~     in comparison to sham-rTMS.~   "
23545|NCT02748993|"~     This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in~     children with atopic dermatitis.~   "
23546|NCT02748980|"~     The purpose of this study is to investigate the prevalence and degree of coronary arterial~     microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with~     type 2 diabetes. Furthermore, the risk factors of coronary arterial microcirulation would be~     screened and identified.~   "
23547|NCT02748967|"~     The purpose of this study is to assess the safety and tolerability of different doses of~     ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20~     years of age.~   "
23548|NCT02748954|"~     The main goal of this study was to compare the effect of a one-session unsupported Internet~     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and~     related variables (mood, confidence and motivation).~   "
23559|NCT02748811|"~     GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail,~     elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive~     geriatric assessment and intervention before and during treatment with chemotherapy.~      The hypotheses are: Optimizing the health conditions and functional status of frail elderly~     patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will~     lead to a higher grade of completing the planned chemotherapy and at higher dose intensity.~     This will also result in a higher overall survival and improve quality of life.~   "
23562|NCT02748772|"~     The purpose of this study is to determine whether Endostar pumping into vein with~     Thalidomide are more effective in the treatment of Advanced Colorectal Cancer (ACRC).~   "
23549|NCT02748941|"~     Cerebrovascular accident (CVA) constitutes a major health public problem. This represents~     the second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large~     arteries, mainly carotid, is involved in about 20% of cases.~      After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on~     stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or~     arteriography.~      The composition of the plaque, showing its vulnerability, is associated with embolic risk~     and stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is~     not satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an~     ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo~     the inflammation of the plaque, its embolic consequences or the mechanical stress it~     undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale~     Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound~     (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile~     (mi RNA). These different modalities must be combined in order to increase the efficiency.~      Based on these encouraging results, the investigator aim at evaluating the ability of~     different methods or their combination to predict the occurrence of ischemic stroke or TIA~     due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he~     investigator want to evaluate the performance of each of these new methods in the~     characterization of carotid plaque instability. Performance evaluation will allow us to~     choose secondarily the most relevant association.~      The investigator propose, as a first step, to make a case-control study with these methods,~     the cases are patients who had an ischemic stroke (authenticated by both the clinical exam~     and brain MRI) on the same side as the carotid stenosis and the controls are patients with~     carotid stenosis but without ischemic stroke. This study is a cross-sectional study because~     it simultaneously measures the occurrence of the event (ischemic stroke) and the~     characteristics of the atheromatous plaque.~      Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included~     with a carotid stenosis with at least a 50% caliber constriction according to NASCET~     criteria. (North American Symptomatic Carotid Endarterectomy Trial).~   "
23550|NCT02748928|"~     Prospective, one arm, baseline-controlled, clinical study for the evaluation of the~     UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal~     fat and circumference reduction.~   "
23551|NCT02748915|"~     The primary objective of this research is to evaluate the relationships between multiple~     data from cochlear implant (CI) adult users to and to estimate predictive models of their~     fitting parameters. In a group of patients, the Electrically-evoked Compound Action~     Potentials (ECAP) will be collected intra-operatively and the correlation with demographic~     data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of~     CI), auditory performances and subjective measures used for implant fitting (hearing~     threshold and most comfortable level) will be calculated. In a second group of experienced~     users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory~     Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12~     months or more of use. Correlation analyzes with demographic data, performance and fitting~     parameters will be performed as well. Statistical predictive models for both fitting at the~     activation or in experienced users should be developed according to the correlation~     analysis.~      The secondary objective is to evaluate the effects of simultaneous stimulation on hearing~     performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in~     patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural~     condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and~     compared in the different conditions.~   "
23552|NCT02748902|"~     The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and~     effective in treating common warts on the hands.~   "
23553|NCT02748889|"~     This is an open-label study with two parts, a Phase I study and a randomized Phase II study.~     This study will be conducted at approximately ten sites in the United States. Approximately~     178 patients will be enrolled in this trial.~   "
23554|NCT02748876|"~     Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients~     with severe heart failure to improve symptoms and survival. Approximately one third of~     patients treated with CRT do not notice significant improvement in their symptoms and this~     may be due to inadequate co-ordination between the upper and lower chambers of the heart~     (atrioventricular dyssynchrony).~      The investigators propose a new method to achieve atrioventricular synchrony in CRT based on~     measurements of electrical conduction from within the heart. Patients referred for CRT~     implantation at Castle Hill Hospital are eligible to participate. During CRT implantation,~     additional measurements, will be recorded from within the heart. After implantation, device~     settings will be adjusted to either standard or electrophysiologically-optimised settings~     with cross-over at 4 months.~      The investigators hypothesis is that patients with optimised settings will derive additional~     benefit compared to patients with standard pacemaker-determined settings.~   "
23555|NCT02748863|"~     The aim of the study is to demonstrate efficacy, safety and tolerability of 2 mL pre-filled~     syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.~   "
23556|NCT02748850|"~     Aldehyde dehydrogenases (ALDHs) are cellular enzymes responsible for detoxifying aldehyde~     resulting from the metabolism of endogenous and exogenous xenobiotic cellular constituents.~     Although ALDHs are considered to play an important role in tumorigenesis, the role of ALDH~     activity in cancer stem cells, and more particularly that of the acute leukemia must be~     specified.~      Several studies have shown that ALDHs are potent apoptogenic compounds on normal or cancer~     cells. Therefore, the cells that were damaged and their increased ALDH activity does not die~     by apoptosis but become highly proliferating. This result is a plausible mechanism for the~     evasion of apoptosis, a characteristic shared by many cancer cells.~      On this basis, it is proposed an innovative approach to cancer chemotherapy through~     inhibition of one of the protective mechanisms against apoptosis, ie the increase in ALDH~     activity than cancer cells put involved in overcoming the lethal effects of damaged roads.~     ALDHs of inhibitors they may have immediate application as anti -cancer in vivo? The limited~     experimental data obtained so far on human tumor xenografts in immunodeficient mice and the~     absence of data on the in vivo toxicology do not allow direct passage to clinical trials.~     Indeed, some members of the ALDH superfamily are expressed constitutively in some vital~     organs they protect against the deleterious effects of xenobiotics and adverse endogenous~     metabolites. Consequently, if ALDHs should be inhibited, of the collateral damages for the~     normal cells could occur. However, when normal cells have not undergone deleterious~     exposure, these harmful metabolites are not or in very small quantities, which do not~     require high levels of ALDH activity, and therefore without harm to the inhibition of cell~     of these enzymes.~      From a hematological point of view, it seems essential to test the therapeutic index of the~     inhibitor of ALDH DIMATE between normal hematopoietic cells and leukemic stem. Indeed, in~     the pathophysiology of acute leukemia, the leukemia stem cells are of major importance~     because they are much more resistant to chemotherapy than more differentiated cells and thus~     causing the high rate of relapse observed in acute leukemia despite the high rate of~     complete remission often obtained. In this study, it will be tested in vitro sensitivity of~     the cluster of differentiation 4 and cluster of differentiation 38 (CD4/CD38) highly~     purified of leukemic origin or normal to the DIMATE compound. The objective will be to~     analyze the effects of DIMATE on the parameters of the proliferation, the apoptose, the~     cytokinins of secretions and the changes transcriptomic in general, in order to better~     define the therapeutic index of this compound and to determine all the precursory~     hematopoietic normals and leukaemic cellular effects. The reversible cytostatic of DIMATE~     effect on normal cells but its irreversible apoptotic effect on cancer cells is an advantage~     to try to eliminate.~   "
23557|NCT02748837|"~     This is the open label, multicenter Phase 1 study which consists of a dose escalation to~     determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary~     evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with~     Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease~     progression.~   "
23563|NCT02748759|"~     Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA,~     about 200.000 injuries are estimated per year, half of which implicate a total rupture of~     the ligament. Data indicates that the number of ACL injuries is increasing in young athletes~     and presents a common problem, especially people playing agility sports.~      One of the most widely used methods for the post-surgical mobilization after ACL is the use~     of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid~     from the articulation and maintain the mobility of the joint and muscles in the knee. Even~     though studies show that, an early mobilization after surgery is beneficial to the~     rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM~     when compared with the goal of application. While literature suggests that efficacy of CPM~     are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some~     studies show that the range of motion measured by the CPM is considerably less than the~     actual ROM.~      As other therapy that provides an effective mobilization of the knee joint, the Specific~     Manual Physical Therapy method (Kaltenborn method) takes in account the physiological~     combination of rotation and gliding of the two joint surfaces. This technique mobilizes the~     femorotibial joint by controlling the tibial plateau anteroposterior during flexion and~     posteroanterior during extension of the knee. Therefore, in the past 30 years there are not~     studies comparing ROM measurements obtained with CPM and manual physical therapy methods.~      It is hypothesized that the benefits of the early passive mobilization after ACL~     reconstructive surgery are diminished by the limited efficacy of currently used CPM devices.~     The aim of our study was to determine the range of motion achieved with the passive~     mobilization using a CPM device compared with a manual method (Kaltenborn method) and to~     assess that ROM measurements provided by the CPM correlates the real ROM.~   "
23564|NCT02748746|"~     Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective~     methods in clinical usage to detect lymphedema in early stage. The aim of this study is to~     reveal comparative relation these two methods on detecting lymphedema in an early stage.The~     another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by~     using bio-electrical impedance analysis in patients after breast cancer surgery.~   "
23565|NCT02748733|"~     The purpose of this study is to validate the concept of adapted automated PD a modified~     Peritoneal Equilibration Test (PET), will be performed in children on chronic PD. Instead of~     a single 4 hour standard dwell, two double mini PET using the same type and total volume of~     dialysate and the same total dwell time (150min) will be performed in randomised sequence.~     An double mini test consists of two identical dwells, reflecting routine PD, the other one~     of a short small dwell followed by a long, large dwell as suggested from adapted PD regimes~     successfully applied in adult PD patients.~   "
23566|NCT02748720|"~     Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at~     the time of transition at birth. For that stabilization during resuscitation is successful,~     it is essential for proper ventilation. This transition is performed with non-invasive~     respiratory support and administration of positive pressure ventilation to establish~     adequate functional residual capacity. The problem is that a peak inspiratory fixed during~     ventilation, and adequate tidal volume is assumed, but usually not measured, unable to~     correct the peak pressure to optimize ventilation and reduce lung damage. In addition,~     frequent adverse events may hinder or impair the effectiveness of the ventilation, with the~     consequent deterioration in the prognosis of the newborn.~   "
23567|NCT02748707|"~     This is a phase II randomized clinical trial to study the effect of COX-2 inhibitor~     Celecoxib and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular~     markers of apoptosis and angiogenesis.~   "
23568|NCT02748694|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)~     of TAK-041 following oral single and multiple doses in healthy participants.~   "
23569|NCT02748681|"~     Study Objectives:~      Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in~     stroke patients, with adherence rates for CPAP therapy of only 30%.~      The primary objective of this study is to determine whether CPAP adherence in stroke~     patients with obstructive sleep apnea can be improved by a CPAP training strategy during~     rehabilitation combined with a telemedicine monitoring system after discharge.~      The secondary objective is to compare recording quality as well as subjective and objective~     sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in~     the management of sleep apnea in stroke.~      Further the investigators aim to study changes in nocturnal systolic blood pressure due to~     CPAP therapy with the pulse transit time method.~      Finally, the investigators intend to study the relationship between CPAP compliance, sleep~     and medical and neurorehabilition outcome parameters.~      Design:~      Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as~     compared with CPAP treatment with a telemedicine monitoring system in stroke patients with~     moderate to severe OSA.~      Setting: Neurorehabilitation center in Vienna, Austria~      Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with~     moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended~     polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of~     out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal~     AHI< 10) at the neurorehabilitation unit.~      Interventions: Patients will be randomized to either standard care with an autotitrating~     CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e.,~     adherence, air leak, residual AHI) daily to a website that will be reviewed by their~     homecare provider. If any problems are identified, the patient will be contacted by his~     homecare provider by telephone. Neurologists performing sleep and neurological scoring will~     be blinded to the randomization.~      Measurements: Recording of the different measuring systems, subjective and objective sleep~     quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP~     determined by means of a non-linear algorithm and an individual one-point calibration of the~     pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH,~     Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.~   "
23570|NCT02748668|"~     The objective of the study is to predict outcomes of patients on extracorporeal membrane~     oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to~     clinical outcomes on ECMO using data collected in the ECMO Registry at Spectrum Health.~   "
23571|NCT02748655|"~     The purpose of this study is to determine whether consumption of alkaline ionized water is~     effective for accelerating sports recovery.~   "
23572|NCT02748642|"~     This single-center, randomized, observer-blinded, placebo-controlled, single and multiple~     ascending-dose study will be conducted in two parts to evaluate the safety,~     pharmacokinetics, and immunogenicity of BITS7201A. Part A will be an ascending, single-dose,~     sequential-group study where participants will be randomly assigned to active drug or~     placebo. Part B will be an ascending, multiple-dose, sequential-group study where~     participants will be randomized to active drug or placebo. Total length of the study is~     anticipated to be approximately 12 months.~   "
23573|NCT02748629|"~     The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness~     following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein~     Operation with lightweight polypropylene mesh.~   "
23574|NCT02748616|"~     In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic~     acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators~     will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or~     Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile~     infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing~     the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid~     composition (80% deoxycholic acid) to maintain growth suppression.~   "
23575|NCT02748603|"~     An observational, retrospective, multicenter, blinded adjudication study to evaluate the~     clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and~     execution in patients with stable Coronary Artery Disease (CAD) and in patients with acute~     coronary syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included~     patients will be diabetic. Also the implementation of selected, key guideline~     recommendations will be examined.~      At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories~     in Italy in the region of Lombardia and Veneto.~      This study will be conducted in compliance with Good Clinical Practices (GCP) including the~     Declaration of Helsinki and all applicable regulatory requirements.~   "
23576|NCT02748590|"~     Efficacy of ulcerative colitis to induce remission in patients with moderate to severe~     active ulcerative colitis.~   "
23577|NCT02748577|"~     Primary Objective of this study: To assess experimental heat pain responses (pain intensity,~     pain unpleasantness, pain catastrophizing, emotional reactivity) in migraineurs vs. healthy~     controls.~      The current tools of migraine pain measurement are inadequate to distinguish the overall~     burden of suffering, as there is an over reliance on a single numerical pain score to~     represent the entire pain experience. Measuring and targeting the affective component, in~     addition to the sensory component of pain, may capture this discrepancy in disease burden.~     The affective component of migraine pain may be just as important as the sensory component~     to target and measure since it significantly impacts outcomes, disability, and has~     therapeutic treatment implications.~      Quantitative sensory testing (QST) is a robust lab paradigm (not a clinical experience) that~     delivers one painful noxious thermal stimuli and asks for simultaneous pain intensity and~     pain unpleasantness scores. By using this in the research, investigators will be able to~     differentiate the sensory (pain quality—what the pain feels like) from the affective (how~     awful/unpleasant the pain feels) components of experimental pain in normal controls vs.~     migrainuers.~      No previous studies have evaluated differences in experimental pain intensity vs. pain~     unpleasantness in migraineurs vs. controls. As migraine pain uniquely involves many altered~     sensory phenomenon (e.g., photophobia, phonophobia), it cannot be assumed that responses to~     experimental pain in migraine will be the same as other clinical pain syndromes. Further,~     different clinical pain syndromes have distinct responses to pain intensity vs. pain~     unpleasantness.~   "
23578|NCT02748564|"~     This phase II trial studies the best dose of aldesleukin when given together with~     pembrolizumab to see how well they work in treating patients with stage III-IV melanoma.~     Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such~     as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving~     aldesleukin and pembrolizumab may kill more tumor cells.~   "
23579|NCT02748551|"~     Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to~     90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2~     Lymphadenectomy is the main option for treatment. Conventional open approach is still the~     current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as~     minimally invasive surgery has gained popularity for the treatment of early gastric cancer~     in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal~     gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by~     experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence~     on the oncologic efficacy.~      Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy~     for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and~     oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal~     gastrectomy for treatment gastric cancer.~   "
23580|NCT02748538|"~     A randomised controlled trial to evaluate the effect of face-down posturing on retinal~     displacement and distortion following retinal detachment repair.~   "
23581|NCT02748525|"~     This study aims to combine the use of IV CCK administration followed by oral milk during a~     HIDA scan to further stimulate the gallbladder contractility and decrease the number of~     false abnormal HIDA scans and unnecessary cholecystectomies in some patients.~   "
23582|NCT02748512|"~     A controlled, multi-center study to evaluate the utilization and safety of the MK II~     inserter and the safety of the Fluocinolone Acetonide Intravitreal (FAI) insert in subjects~     with non-infectious uveitis affecting the posterior segment of the eye.~   "
23583|NCT02748499|"~     This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise~     program on the perceived health status and sleep quality of the community-dwelling older~     adults.~   "
23584|NCT02748486|"~     The purpose of this study is to determine whether modules of Metacognitive Training: Jumping~     to Conclusions and To empathize... are effective in the treatment of patients with~     schizophrenia. Also it was investigated whether these modules have specific impact on~     cognitive biases severity.~   "
23585|NCT02748473|"~     Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve~     the pelvic floor muscle strength on sedentary nulliparous women.~   "
23586|NCT02748460|"~     This is a multi-centre, multinational, prospective, non-interventional study in females with~     a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a~     long term manner is planned, and in subjects who were previously exposed to UPA in the long~     term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive,~     eligible, patients will be invited to enrol from approximately 100-150 European Union (EU)~     clinical practice sites in approximately 15 countries. Patients will be followed for an~     observation period of 60 months (5 years) from treatment start. Investigators are to manage~     and treat patients according to their standard medical practice.~      The specific objectives of the study are to assess the long term safety, including~     endometrial safety, of Esmya in standard medical practice and the prescription patterns of~     Esmya in standard medical practice.~      The exploratory objective is to assess patients' quality of life in a long-term treatment~     setting.~   "
23600|NCT02748278|"~     IVF is a well-established method to treat various causes of infertility. Some studies have~     suggested that ethnicity affects the success of IVF. This is a prospective study involving~     two tertiary IVF units in Hong Kong and Australia. The IVF outcome between Chinese and~     Caucasians will be compared.~   "
23587|NCT02748447|"~     Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo~     intensive care is an important risk factor for risk of neurodevelopmental impairment. Near~     infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation.~     Automated FiO2 adjustment can maintain arterial oxygen saturation (SpO2) within a target~     range and may reduce risk of fluctuation of cerebral oxygenation.~      Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2~     within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to~     SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with~     supplemental oxygen.~   "
23588|NCT02748434|"~     Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy~     through short-term continuous glucose monitoring has shown inconsistent results and it is~     yet unknown how or if subclinical lipohypertrophy affects absorption. In this study~     investigators propose to enroll at least 20 people who participated in phase 1 and who were~     determined to have subclinical lipohypertrophy to examine the correlation between glycemic~     control and amount of insulin injected in subclinical hypertrophic areas using capillary~     blood glucose and continuous glucose monitoring.~   "
23589|NCT02748421|"~     In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT )~     coupled to assess the extent , depth and change of retinal architecture in the perioperative~     period . Thus , they will evaluate what the optimal maneuvers of dissection of macular~     membranes to obtain a more satisfactory result of the rearrangement in the retinal layers .~     Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing~     the concentration used or reduce the exposure time. Thus, they can get the potential~     decrease in retinal toxicity may be generated by them.~   "
23590|NCT02748408|"~     This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.~   "
23591|NCT02748395|"~     The purpose of this study is to determine whether the injection of triamcinolone and~     lidocaine is effective in relieving chronic abdominal wall pain.~   "
23592|NCT02748382|"~     Despite evidence of the physiologic benefits and possible lower mortality associated with~     low chloride solutions, normal saline remains the most wildly used fluid in the world. Given~     uncertainty about the impact of lower chloride versus higher chloride solutions on~     mortality, it is unlikely that clinical practice will change without new and direct RCT~     evidence. Editorials published in leading critical care journals have called for RCT's to~     address this important clinical question. The proposed feasibility RCT will investigate the~     feasibility of a large-scale trial directly comparing low chloride versus normal chloride~     for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.~   "
23593|NCT02748369|"~     This is a pilot study to establish an arterial venous methodology to measure the activity of~     the TCA cycle or flux directly in tissues of human beings. It will also perform correlative~     studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and~     exosomes derived from the arterial venous supply of tissues with correlation to the TCA~     cycle activity.~   "
23594|NCT02748356|"~     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's~     National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI)~     Center for Genetic Medicine Research, Georgetown University, and MedStar Georgetown~     University Hospital, the overall objective of this study is to develop, validate, and assess~     a patient-initiated, probiotic-based, selfmanagement protocol that is initiated at the time~     of urinary symptoms. The self-management protocol will allow patients to manage urinary~     symptoms and avoid potentially unnecessary antibiotic use, and provide a readily-available~     means of maintaining health, function, and independence throughout the lifespan.~   "
23595|NCT02748343|"~     The purpose of this study is to compare use of a tissue-engineered bone to use of a standard~     allograft bone to treat bone defect in patients. The hypothesis is that use of the~     tissue-engineered bone is effective and safe to treat the bone defect in patients.~   "
23596|NCT02748330|"~     This will be a single-center, randomized, open-label, active-controlled, parallel-group~     study to investigate the platelet inhibition of Ticagrelor versus Clopidogrel with~     acetylsalicylic acid (ASA) as background therapy in approximate 40 patients with stable~     coronary artery disease (SCAD) and type 2 diabetes mellitus (DM) after recent successful~     elective percutaneous coronary intervention (PCI) by evaluation of the P2Y12 reaction unit~     (PRU) by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on treatment day~     15±2.~   "
23597|NCT02748317|"~     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar~     Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of~     Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and~     Georgetown University Medical Center, the overall objective of this study is to develop,~     validate, and assess a patient-initiated, probiotics-based, self management protocol that is~     initiated at the time of urinary symptoms. The self-management protocol will allow patients~     to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a~     readily-available means of maintaining health, function, and independence throughout the~     lifespan.~   "
23598|NCT02748304|"~     The purpose of the study is to observe the effect of sorafenib combined with aspirin in~     preventing the recurrence in high-risk patients with hepatocellular carcinoma.~   "
23599|NCT02748291|"~     There are over 8.75 million people in the United Kingdom with osteoarthritis in their knees.~     The effect of this condition can be debilitating. Symptoms are due to wear and tear of the~     knee joint. Some people can suffer with knee pain and stiffness. This study will look at~     whether walking improves the symptoms of knee osteoarthritis.~      Investigators will recruit anyone with knee pain over the age of 45 years in Nottingham.~     Participants will undergo a full assessment by a qualified Doctor. After assessment,~     Participants meeting the eligibility criteria will be invited to join the study.~     Participants will be randomly allocated into 2 groups. One group will receive standard~     health and exercise advice. The other group will be allocated a walking activity. This group~     will undertake 6,000 walking steps each day. Participants will provide pedometers to monitor~     this walking activity.~      The effect of walking will be compared using questionnaires. These will look at pain levels,~     quality of life and physical activity. The participants will complete these questionnaires~     before the study, at the 6 week midpoint and at the end of the 12 week intervention.~   "
23601|NCT02748265|"~     This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved~     for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and~     intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia~     either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).~   "
23602|NCT02748252|"~     With aging of the persons living with HIV, cardiovascular diseases now account for~     substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its~     incidence doubles every decade over 55 years of age.~      The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute~     phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are~     referred to these units in the first hours of a stroke and not to their infectious disease~     units which is a loss of chance.~      It would also be important to know whether HIV patients need specific protocols for stroke~     emergency management.~      The study aims to compare the functional prognosis after the first occurrence of an ischemic~     stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by~     HIV.~   "
23603|NCT02748239|"~     A new diabetes education program for the initiation of non-intensive insulin therapy in type~     2 diabetic patients (MEDIAS 2 CT) was developed.~      In the evaluation, this new developed program is compared with an education programs which~     is currently used for diabetes education. It is expected that the new developed program~     (MEDIAS 2 CT) can demonstrate non-inferiority with regard to the main outcome variable~     glycemic control. If non-inferiority can be demonstrated superiority of this program will be~     tested.~   "
23604|NCT02748226|"~     1. Study design: multicenter retrospective and prospective observational study~        2. Study Cohort :~             1. Retrospective cohort: This cohort retrospectively enrolls patients with lower~               extremity artery disease who underwent endovascular treatment from January 2006 to~               the date of approval by IRB in the participating hospitals. Informed consent was~               waived by IRB.~             2. Prospective cohort: This cohort prospectively enrolls patients with lower~               extremity artery disease who undergo endovascular treatment from the date of~               approval by IRB to July, 2018 in the participating hospitals. Informed consent~               will be obtained prior to enrollment.~        3. Baseline clinical and lesion characteristics, procedural and post-procedural data,~          clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary~          patency and target lesion revascularization rates of the total cohort and patient~          subgroups are evaluated. Risk factors of restenosis and target lesion revascularization~          are determined.~   "
23605|NCT02748213|"~     This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin)~     and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with~     previously untreated HER2-positive advanced and/or metastatic breast cancer.~   "
23606|NCT02748200|"~     In this phase 1 trial, the investigators will prospectively evaluate 3 different external~     beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to~     40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of~     abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of~     fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is~     delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a~     simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3~     different dose levels will be implemented in order to increase the biological equivalent~     dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.~   "
23607|NCT02748187|"~     Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only~     psychological models and treatments that has been designed specifically for patients~     diagnosed with chronic depression. CBASP in combination with antidepressants has been found~     to be the most effective treatment for chronic depression. Similar to CBASP, Interpersonal~     Psychotherapy (IPT) has been found to be effective treatment for depression and has an~     interpersonal focus. Despite an increasing amount of research into these interventions,~     researchers are less aware of the role that specific and common ingredients are accounted~     for in outcomes. Given that CBASP and IPT are treatment models endorsed by the National~     Health Service Lothian (NHS Lothian), gaining a deeper knowledge and understanding about the~     active ingredients involved in their success ensures current practice is embedded in an~     evidence base. Conducting this research adds to the gap in the literature and identifies~     areas in which further exploration is warranted. Given the emphasis on therapist variables~     in relation to treatment outcomes, the results of this research will have wider implications~     from a service resource perspective. Training may be altered or needs emphasised in line~     with the results of the study to ensure most efficacious outcomes.~      Limited research has looked at therapist and client variables that may contribute to~     therapeutic alliance/engagement, and clinical outcomes. The current study proposes to~     explore two variables that are hypothesized to contribute to outcomes based on the~     theoretical framework CBASP and IPT is grounded on, namely therapist and client attachment~     style and reflective functioning. This will be done by providing CBASP or IPT to a small~     number of participants and gathering outcome data from therapists and clients at each~     therapy appointment. Participants will also complete the Adult Attachment Interview (AAI), a~     semi structured interview which can also be coded for reflective functioning. This is a~     proof of concept case series design that aims to provide an analysis of individual~     psychological change in relation to the above variables of interest.~   "
23608|NCT02748174|"~     This is a naturalistic study of 100 migraineurs and 75 post concussive headache patients who~     will be asked to record their headaches, medications, sleep and other behaviors in a~     smartphone app called Curelator. The software was developed to identify possible headache~     triggers. We seek to determine whether there might be protective headache factors. Patients~     will be given audio files with relaxation therapies. We seek to understand whether this self~     relaxation therapy and/or traditional evidence based behavioral treatment recommended during~     a patient visit is protective against migraine attacks.~   "
23609|NCT02748161|"~     Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and~     are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization~     (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy~     drug, doxorubicin, and delivered to the tumor through an arterial catheter.~      The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also~     causes arterial embolization, the process in which a blood vessel is blocked. Treatment of~     HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size)~     the cancer in order to meet the criteria which may allow patients to become candidates for~     liver transplantation. The purpose of this study is to compare tumor response and medical~     outcomes for patients who undergo DEB-TACE with standard endhole catheter versus Surefire®~     Infusion System.~   "
23610|NCT02748148|"~     The purpose of this study is to identify challenges and successes associated with~     implementing an enhanced medication therapy management service in primary care practice.~   "
23612|NCT02748122|"~     This feasibility pilot is intended to understand whether adolescents with Type 2 Diabetes~     (2DM) can be transitioned to a continuous subcutaneous insulin injection (CSII) and if so,~     assess whether CSII is a feasible treatment modality and improves quality of life (QOL) in~     adolescents with T2DM over 3 month period.~   "
23613|NCT02748109|"~     Our central hypothesis is that chronic balance deficits after mild traumatic brain injury~     (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped~     by rehabilitation. There are two objectives of this proposal; the first objective is to~     characterize balance deficits in people with mTBI. The second objective is to use a novel~     auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and~     balance control.~   "
23614|NCT02748096|"~     Patient-specific instrumentation guides have previously been used to improving surgical~     accuracy and ease of implantation during Total Knee Replacement but have received less~     attention for implanting Unicompartmental Knee Replacement. The aim of this prospective~     study is to compare the accuracy of implantation and functional outcome of mobile bearing~     medial Unicompartmental Knee Replacement implanted with and without patient specific~     instrumentation by experienced knee surgeons.~   "
23615|NCT02748083|"~     This trial attempts to evaluate the effects of intensive transcranial direct-current~     stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting~     state brain network connectivity, especially increasing connectivity in the tasks related~     network, and increasing activation the DLPFC in a working memory task. Half of the~     participants will be randomized to tDCS group, while the other half will be randomized to~     receive sham tDCS.~   "
23616|NCT02748070|"~     While oral steroids have been shown to be effective in the management of patients with~     chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without~     polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a~     benefit in this disease state, steroids are often prescribed as a component of~     post-operative care after sinus surgery for patients without polyps. Oral steroids carry~     with them significant adverse effects, and should be prescribed thoughtfully. The aims of~     this study are to determine if oral steroids in the peri-operative period improves patient~     outcomes in CRS without polyps.~   "
23617|NCT02748057|"~     The study will assess the safety and tolerability of MK-0653H (Ezetimibe 10 mg+ Rosuvastatin~     2.5 mg) and MK-0653H (Ezetimibe 10 mg+ Rosuvastatin 5.0 mg) through up to 52 weeks in~     Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe~     10 mg or Rosuvastatin up to 5 mg.~   "
23618|NCT02748044|"~     The prevention and treatment of diseases via artificial intelligence represents an ultimate~     goal in computational medicine. The artificial intelligence for systematic clinical~     application has not yet been successfully validated. Currently, the main prevention strategy~     for rare diseases is to build specialized care centers. However, these centers are~     scattered, and their coverage is insufficient, resulting in inadequate health care among a~     large proportion of rare disease patients. Here, the investigators use deep learning to~     create CC-Cruiser, an intelligence agent involving three functional networks: pick-up~     networks for diagnostics, evaluation networks for risk stratification and strategist~     networks to provide assisted treatment decisions. The investigator also establish a cloud~     intelligence platform for multi-hospital collaboration and conduct clinical trial and~     website-based study to validate its versatility.~   "
23619|NCT02748031|"~     Photography is considered as one of the most important means to promote evidence-based~     medical practice in pediatric ophthalmology.This study is to investigate the feasibility of~     congenital cataract morphological classifications and monitoring using slit-lamp-adapted~     anterior segmental photography in a large cohort that included uncooperative children.~   "
23620|NCT02748018|"~     The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid~     Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home~     setting. A diverse population of patients with type 1 diabetes will be studied. The study~     population will have a large range for duration of diabetes and glycemic control, as~     measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of~     their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous~     Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)~   "
23621|NCT02748005|"~     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of~     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek~     seeds extract are known to possess protodioscin and the extract is reported to improve sperm~     count, sperm morphology and protective effect on male reproductive system. All the~     participants will receive one capsule (500 mg) of furosap once a day.~   "
23622|NCT02747992|"~     Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting~     after breast cancer surgery when used in addition to general anesthesia or sedation.~     However, major breast cancer surgery involves areas beyond the breast tissue, such as~     pectoral musculature.~   "
23623|NCT02747979|"~     A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of~     combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules~     removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.~      There are two phases of study for each subject. Phase 1 (screening phase). During this~     phase, each potential subject will be evaluated to determine if he/she is eligible for the~     study.~      Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once~     per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3~     months.~   "
23624|NCT02747966|"~     A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable~     Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at~     various age range and both sexes are recruited to observe their access flow, access~     recirculation and cardiac function and assess their relationship.~   "
23625|NCT02747953|"~     The program will provide early access to the investigational drug gilotrif in patients with~     advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or~     gefitinib.~      The Compassionate Use Programme will also provide additional safety information on gilotrif~     use.~   "
33744|NCT02615483|"~     The purpose of the present study is to investigate the effect of a Web- based Platform (WP)~     on anxiety and depression and health economics among patients undergoing lumbar spine fusion~     (LSF).~   "
23626|NCT02747940|"~     Brain signatures as objective measures of acute pain have been characterized with~     functional magnetic resonance image and machine learning technology. As compared to acute~     pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain~     remain subjective and suboptimal, and the brain signatures for chronic pain are largely~     unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders~     with high disability and intractability with prevalence of around 2% for both diseases.~     These two chronic pain disorders have shared clinical presentations (abnormal pain~     sensitivity, mood and sleep disorders), pathophysiology (central sensitization) and medical~     treatment (anti-depressants), despite different body parts are involved (head vs. whole~     body). The present integrated project aims to characterize both common and disease-specific~     brain signatures of chronic pain by investigating these two chronic pain disorders. Our~     findings may shed some light on the key mechanisms of pain chronification, and may pave the~     way for the optimization of diagnosis and prognostication, as well as formulation of~     personalized medicine in chronic pain, so as to improve life quality of these patients and~     to reduce socioeconomic loss.~      The present project includes three interdisciplinary sub-projects (plus one animal study,~     not listed here):~      A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain~     chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis~     of brain connectomes C. Data stream mining technology for multimodal physiological signals~     of chronic pain: real-time tracking and clinical correlation~      The specific aims of the present projects include:~        1. Identification of common and disease-specific brain signatures for chronic pain~          (sub-projects A, B, C)~        2. Investigation of clinical indicators with predictive values by machine learning~          analysis of big data (sub-projects A, B, C)~        3. Elucidation of the specific anatomical structures or neural networks underpinning pain~          chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year~          pilot study of the 4-year longitudinal study, we will establish experimental platforms~          for each sub-project, start to recruit participants and perform endophenotyping, as~          well as have a preliminary integration for sub-projects A, B and C.~   "
23627|NCT02747927|"~     The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue~     Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to~     any of the four dengue virus serotypes in 4 to 16 year old participants.~   "
23628|NCT02747914|"~     Leg spasticity is common problem encountered with a large proportion of patients suffering~     with multiple sclerosis (MS) with an increasing severity as the disease progresses. It~     mostly affects the antigravity muscles that significantly complicates transfer, increases~     fatigue and makes walking more difficult. Hence, leg spasticity often interferes with~     patients' mobility and significantly influences their quality of life. A great number of~     multidisciplinary rehabilitation studies has shown a significant effect of numerous specific~     functional changes in patients with secondary (SP) and primary progressive (PP) MS but there~     are no reviews related to spasticity. The positive therapeutic effect of modulating~     Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies,~     in patients with relapse remitting clinical form in the remission phase of the disease. The~     effect of TMS on clinical measures of lower limb spasticity, functional inability and the~     quality of life in patients with SPMS and PPMS will be examined in this study. The objective~     to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can~     bring more improvement in lower limb spasticity than ET treatment alone in these patients.~   "
23629|NCT02747901|"~     The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on~     muscle strength and functional performance outcomes in patients with TKA during early~     postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to~     control, KT and CT groups (nC=nKT=nCT=37).~   "
23630|NCT02747888|"~     Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in~     families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in~     children and families, with a particular interest in understanding genes and other factors~     that may put individuals at risk for developing thyroid cancer and thyroid nodules.~        -  In this study, family and medical history information is collected alongside a blood or~          saliva sample for genetic studies.~        -  Individuals with a past or present childhood thyroid cancer/nodule or a thyroid cancer~          suspected to be inherited in their family are invited to participate.~   "
23631|NCT02747875|"~     The purpose of this study is to determine if methadone improves postoperative pain control~     in pediatric patient's undergoing cardiac surgery.~   "
23632|NCT02747862|"~     The primary objective of this chart review study is to evaluate the outcomes of subjects~     with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous~     Polyposis (FAP) who have not undergone surgical resection of the colon.~      A secondary objective of this study is to compare 1) the colonoscopic and pathology~     histories including history of ampullary adenoma in the duodenum over family generations, 2)~     the use of chemopreventive medications, and 3) clinical features of subjects who pursued~     prophylactic surgical resection of the colon with those that have elected to continue~     routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp~     burden, ampullary adenoma and level of dysplasia, etc) which may influence management~     decisions.~   "
23633|NCT02747849|"~     The investigators believe in order to strengthen the evidence in support of transcutaneous~     foot stimulation in this population the investigators need to move forward with a randomized~     comparison study using the TENS device on the hand and foot as a control.~   "
23634|NCT02747836|"~     This study evaluates the ability of ultrasound to measure the movement of tendons and nerves~     within the human carpal tunnel.~   "
23635|NCT02747823|"~     This study aims to investigate the bioequivalence of new formulation of bevacizumab called~     CBT124 and safety when compared to two already marketed formulations, one approved in US and~     other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both~     inclusive) can participate in this trial.~      Participants will be randomised (allocated by chance) to either a test formulation or one of~     the two marketed formulations of bevacizumab. Drugs will be administered intravenously once~     only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of~     drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and~     immunogenicity (body's immune response) of the 3 drugs. In order to measure this, blood~     samples will be collected at various points after treatment has been given.~   "
23664|NCT02747433|"~     Stroke is the leading cause of long-term disability in older adults in the United States. At~     six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke~     each year continue to have motor impairments that inhibit functional use of the weaker arm~     during daily activities and negatively impact quality of life. Rehabilitation robots provide~     clinicians with new treatment options to improve movement and arm function after stroke. The~     purpose of this pilot study is to develop and test a therapy called the Active Learning~     Program for Stroke (ALPS). We are combining this therapy program with robot-assisted~     therapy and a home program for the stroke-affected arm and hand.~   "
23636|NCT02747810|"~     Background: Previous animal model studies at the University of Pittsburgh have shown a~     significant impact on inhibiting bladder over activity and increasing bladder capacity with~     neuromodulation techniques, specifically tibial nerve stimulation. This has been translated~     into adult clinical trials through the department of urology. Through the use of a~     commercially available subcutaneous nerve stimulator placed on the dorsum of the foot,~     researchers were able to demonstrate a significant increase in bladder capacity and the~     delay of voiding sensation for up to 5 hours after stimulation in eight healthy subjects.~     This prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling~     patients.~      The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting)~     is very common in the pediatric and teenage population, particularly in patients without~     daytime bladder over activity symptoms. When behavioral modification (i.e. refraining from~     night-time fluid consumption and bladder irritants, and bed wetting alarms for timed~     voiding) fails which it often does there is a paucity of effective and safe treatment~     options. Medications can be tried, but generally these are from the tricyclic antidepressant~     family and carry significant side effects limiting the use.~      Aim: Researchers aim to utilize the same technology currently being studied under IRB~     PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes~     for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be~     asked to complete a questionnaire about any skin irritation or experiences of toe twitching~     while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The~     primary outcomes of this study are safety and functionality of the New TENS unit~   "
23637|NCT02747797|"~     Lucitanib is an oral multi kinase inhibitor designed to block the action of certain~     molecules called angiogenic factors that may cause tumors to grow. These factors are~     called vascular endothelial growth factor (VEGF), platelet derived growth factor receptor~     (PDGFR) and fibroblast growth factor (FGF). Lucitanib is experimental and not approved by~     the FDA for the treatment of cancer.~      The purpose of this study is to look at the effects of lucitanib in cancer patients whose~     cancers harbor aberrations in FGFR, VEGFR, PDGFR or other markers predicted to be sensitive~     to lucitanib. This study will also look for biomarkers in samples of blood and tumor tissue~     to identify patients most likely to respond to lucitanib. Biomarkers are substances such as~     genetic material (DNA and RNA) and proteins found in blood and tumor tissue that might show~     if a cancer patient will respond or not respond to a drug.~   "
23638|NCT02747784|"~     The purpose of this open, monocentric randomized, parallel-group, controlled trial is to~     compare two different computer-based cognitive training programs regarding the efficacy to~     prevent the 3-months incidence of postoperative cognitive dysfunction in female patients~     after elective urogynecological surgery.~   "
23639|NCT02747771|"~     This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy~     for trichotillomania at three clinical sites in Norway.~   "
23640|NCT02747758|"~     This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain~     in patients with chronic neuropathic pain undergoing treatment with regional~     anaesthesiological techniques.~   "
23641|NCT02747745|"~     The growing number of persons with dementia (PWDs) calls for policy changes and service~     innovation. Recent case management (CM) research is recognized by its positive impacts on~     family caregivers (FCGs) of PWDs. However, research gaps are identified, including the~     paucity of theoretical based CM practice and a lack of mediator effects. Therefore, the~     original purpose of this five-year project was to implement a theoretical-based randomized~     controlled CM intervention for FCGs of early to moderate PWDs at home based on a stress~     model and tailor to needs prioritized by FCGs. This project was funded by the Minister of~     Scientific and Technology for the first two years and accomplished the first two aims: 1.~     First year: to develop and test the psychometric properties of related instruments and~     protocol (cross-sectional study); 2. Second year: to conduct a feasibility test for the CM~     intervention (a pilot RCT). The purpose of the current project is to achieve aim 3 (three~     years): to implement a 4-month CM intervention (the main RCT). In total, there will be 2~     home visits, 2 phone calls to the dyads, and receiving telephone calls from the FCGs during~     the working hours. Investigator will collect 4-time point data at T0 for base line data, T1~     (after the recruitment, 4 th month, the first follow up), T2 (after the recruitment, 6th~     month, the second follow up) and T3 (after the recruitment,12 th month). Investigator will~     recruit 76 dyads in three years (38 dyads for each group)(n = 152 in total). The primary~     outcomes are FCG QoL and PWD behavioral problems, while the secondary outcome is the~     percentages of PWD status (i.g. nursing home admission) and the frequency of PWD acute~     hospitalization. Investigator will also test of mediator effect of FCG self efficacy using~     statistical analysis method such as Hierarchical Linear Modeling (HLM).~   "
23642|NCT02747732|"~     This is a phase 2 study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (ibrutinib), in~     combination with bendamustine and rituximab (BR) in subjects with previously treated~     aggressive B cell non Hodgkin lymphoma (aB-NHL) including any subtype of diffuse large B~     cell lymphoma (DLBCL) primary mediastinal B cell lymphoma (PMBCL), double and triple hit~     DLBCL, transformed indolent lymphoma, unclassifiable aggressive B cell lymphoma between~     DLBCL and Burkitt lymphoma. Patients with CNS involvement (primary or secondary) will be~     excluded. Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent,~     orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase~     currently FDA approved for the treatment of relapsed Mantle cell lymphoma (MCL), Chronic~     Lymphocytic Leukemia (CLL) and waldenstrom Macroglobulinemia (WM).It is under constant~     investigation for the treatment of other B-cell malignancies. The initial approval of~     ibrutinib was received on 13 November 2013 by the United States Food and Drug Administration~     for the treatment of adult patients with MCL who have received at least 1 prior therapy.~     Ibrutinib has not been approved for marketing for the treatment of aggressive B cell~     lymphoma although Phase I trial in this setting has already been published. In Israel~     ibrutinib is registered for the treatment of MCL and CLL.~   "
23643|NCT02747719|"~     Both light and exercise are effective countermeasures for space and ground-based crews for~     circadian phase resetting and alertness levels. The investigators propose to test the~     combined effects of these two countermeasures to determine whether adding exercise to light~     stimuli will further improve circadian phase resetting and alertness.~   "
23644|NCT02747706|"~     There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days~     of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization~     visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the~     community) can be effective in reducing hospitalizations for asthmatic children.~      This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to~     reduce asthma-related pediatric hospitalizations and emergency department visits.~   "
23646|NCT02747667|"~     Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract~     surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the~     continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then~     several case reports and case series were observed. In-the-bag IOL dislocation is a~     well-known postoperative complication, especially in eyes with weak zonules as seen in~     pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).~      In this retrospective study, medical records of all patients with IOL related problems after~     implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology~     Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and~     predisposing factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic~     complications will be investigated and compared amongst each other or control patients.~     Incidence rates for each IOL complication will be calculated. For in-the-bag dislocations~     odds ratios for each predisposing factor will be calculated.~   "
23647|NCT02747654|"~     Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment.~     However, treatment with INH is complicated by polymorphisms in the expression of the enzyme~     system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its~     associated hepatotoxicity. The objective of this study was to develop an individualized INH~     dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot~     study.~   "
23648|NCT02747641|"~     The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the~     treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary~     endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale~     (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by~     patient filled Vulvovaginal Atrophy.~   "
23649|NCT02747628|"~     Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective~     laparoscopic cholecystectomy under general anesthesia were included in this randomized~     controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group~     patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h).~     Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP,~     postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis,~     respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12~     hours postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative~     bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.~   "
23650|NCT02747615|"~     Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II~     were included in this randomized study who were divided into the study group of 30 patients~     who had been transfused autologous blood and the control group of 30 patients who had been~     transfused only allogeneic blood. Parenteral iron preparation was given to all patients of~     the study group after each donation. Intraoperatively all patients of the study group~     received 2 grams of intravenous tranexamic acid. This study was conducted through the~     laboratory analysis of the hemoglobin and the hematocrit values during blood donation and~     for both groups in the pre-operative and the post-operative period and the assessment of the~     amount of transfused blood units in both groups.~   "
23651|NCT02747602|"~     To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after~     administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard~     breakfast.~      To evaluate the effect of a high fat diet on serum ketone body levels after administration~     of CT oil with a high fat breakfast versus a standard breakfast.~   "
23652|NCT02747589|"~     In this study, the investigators intend to evaluate the use of a commercially available~     neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace~     RNS System has a proven record of safety and reliability was approved by the FDA in November~     2013. The RNS System is indicated for use in patients with epilepsy and includes a skull~     implanted neurostimulator. No modification to the RNS System is required for this study.~     This study will use this device to better understand the effect of stimulation on the visual~     parts of the brain.~      The main purposes of this study are to confirm the desired location to implant a device in~     the visual cortex, determine the amount of energy needed to elicit vision, and assess the~     nature of the vision that is produced. This information is important to have early in the~     process of designing a visual cortical prosthesis that could eventually be used for~     commercial use.~   "
23653|NCT02747576|"~     Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social~     deficits, including specific skills such as facial affect recognition which is the ability~     to recognize the emotional expressions of another person. Because the underlying mechanisms~     of these deficits are poorly understood, the investigators propose to examine~     social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity,~     including an established core neural network of face perception in MB survivors and healthy~     controls. By comparing these outcomes between survivors of MB and healthy controls,~     investigators seek to identify the areas of the brain that help individuals recognize~     emotions.~      Primary Objective:~        -  To evaluate social cognition in adolescent and young adult survivors of pediatric~          medulloblastoma.~      Secondary Objective:~        -  To examine indices of brain integrity and function and their association with facial~          affect recognition in survivors of pediatric medulloblastoma.~   "
23654|NCT02747563|"~     Patients with know prostate cancer (PCa) under active surveillance and aged matched controls~     without evidence of PCa will have a PSA blood test prior to and following standardized~     digital rectal examination~   "
23655|NCT02747550|"~     The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous~     two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.~   "
23665|NCT02747420|"~     This is a prospective, single center, double-blind, randomized, controlled trial comparing~     the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder~     Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.~   "
23666|NCT02747407|"~     This research trial studies qualitative, qualitative, and functional studies over the first~     year in measuring immune system response in patients with brain tumors. Measuring the number~     of immune cells, whether these immune cells work correctly, and response to 2 vaccines at~     several times during the first year of treatment may help find out how active the immune~     system responds to fight infection and cancer.~   "
23656|NCT02747537|"~     This study proposes to treat patients with the combination of sorafenib and irinotecan.~     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors~     possess a non-synonymous mutation in Raf, PDGFR, VEGFR, Flt-3, KIT, JAK, STAT, RAS, MEK, or~     ERK will be eligible for the study. Very few phase 2 clinical trials have been performed in~     pediatrics using targeted agents in combination with conventional chemotherapy agents.~     Furthermore, since some combinations such as the combination of this study (sorafenib and~     irinotecan) have shown additive/synergistic effects in preclinical studies, therapy~     selecting for those patients who possess mutations targeted by the TKI of the study, may~     unveil activity that has not been previously observed. Thus, the investigators hope to~     determine whether the addition of additive/synergistic chemotherapy will increase efficacy~     of the targeted agent and/or increase tumor susceptibility to the targeted agent, resulting~     in increased anti-tumor activity.~   "
23657|NCT02747524|"~     This study applied a matched cluster, controlled design, using community cluster as the unit~     of randomization. Communities were first matched during the formative research phase and~     randomized into treatment (Vita Mamba + deworming) or control (deworming) groups, using a~     simple experimental 1:1 design. The principal investigator generated the random allocation~     sequence and assigned the cluster to groups. Children were followed longitudinally for Hb~     concentration and anthropometric measures were taken at baseline (November 2014) and endline~     (June 2015). Parents were surveyed at baseline for household-level socioeconomic and~     demographic information; environmental conditions including water, hygiene, and sanitation;~     and child diet and morbidities.~      All children in the intervention schools received the Vita Mamba once per school day from~     November 2014 to June 2015, for approximately 26 weeks. Children in both groups received~     Albendazole at baseline in November 2014. Compliance was monitored by teachers and tracked~     by collection of empty packages. Lessons learned from another school feeding trial by the~     study team were applied to increase compliance such as opening the packages for the children~     immediately prior to consumption to discourage selling or sharing later with family members.~     Vita Mamba was developed for the urban school trial by the research team with~     representatives from Edesia (a US-based nonprofit manufacturer of ready-to-use foods with~     expertise in research and development) and Nutriset (the parent company in the PlumpyField~     network). Meds & Food for Kids, a nonprofit manufacturer of ready-to-use foods in Haiti~     using locally produced peanuts, produced the Vita Mamba for this trial. Vita Mamba (50 g)~     contains 260 kcal and meets >75% of the Recommended Dietary Allowance (RDA) for critical~     micronutrients (S1 Table).~   "
23658|NCT02747511|"~     Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain~     scores in patients who present to the emergency department (ED) with a complaint of~     headache. A total of 150 patients age 13-55 presenting to the emergency department with~     headache will be enrolled from October 2015 - October 2016. Patients will be randomized and~     pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will~     be performed by telephone at 24 hours.~   "
23659|NCT02747498|"~     The purpose of this study is to compare the clinical outcomes depending on catheter ablation~     strategy for repeat ablation procedure among the patients with recurred atrial fibrillation~     after de novo catheter ablation. After randomization, the investigators will conduct~     circumferential pulmonary vein isolation alone in a group, and additional posterior box~     isolation and anterior linear ablation in the other group. Non-pulmonary vein foci ablation~     will be done in all patients. The investigators will compare clinical recurrence rate,~     complication rate, and procedure time, etc.~   "
23660|NCT02747485|"~     New strategies are needed to early detect myocardial involvement in these diseases.~     Histological studies showed that diffuse fibrosis and cardiomyocyte hypertrophy precede the~     LV remodelling (dilatation) observed by cardiac imaging. Quantification of LV diffuse~     myocardial fibrosis using magnetic resonance imaging (MRI) could reach this goal. Recently,~     contrast enhanced cardiac MRI has been used to measure the extracellular volume fraction~     (ECV) of the myocardium, and it has been able to detect diffuse myocardial fibrosis. In~     diseases in which increased collagen deposition enlarges the extra-cellular space, the ECV~     can act as a fibrosis index. ECV is correlated with the amount of fibrosis measured by~     histology. Left ventricular overloads induced by regurgitant VHD result in cardiomyocyte~     hypertrophy and diffuse fibrosis. Other methods can be used to estimate the degree of~     myocardial fibrosis such as the serum level of galectine-3 or ST2. Moreover, although the~     pathophysiological mechanisms leading to the occurrence of myocardial fibrosis differ in~     patients with various cardiac diseases, the cellular effectors of fibrotic remodelling are~     common and involve similar signalling pathways. At the cellular level, key progression of~     ventricular hypertrophy is associated with increased cardiomyocytes apoptosis and fibrosis,~     suggesting that these two processes are responsible for the transition.~      To our knowledge, no study has analysed the impact of the rate of myocardial diffuse~     fibrosis, non-invasively estimated by ECV, in the risk of LV dysfunction during MR and AR,~     especially after surgery. The measurement of ECV could become an important tool for risk~     stratification in left-sided regurgitant VHD. Thus, it would provide an early marker of LV~     myocardial involvement before the occurrence of global remodeling, might help physicians in~     surgical decision, and would improve prognosis. This is an innovative original project~     because it uses modern imaging modalities to answer to a crucial question. The clinical~     implications would be important because this work would modify the international surgical~     indications of MR and AR in order to finally improve the prognosis of patients with this~     frequent heart disease. Moreover, investigators will analyze the genetic factors that can~     influence the myocardial reaction resulting from these regurgitations, which will improve~     the quality of this work and offer new future perspectives.~      Investigators hypothesize that the ECV measurement could be used as an early predictor of LV~     dysfunction in the left-sided valve regurgitations.~   "
23661|NCT02747472|"~     Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of~     insulin secretion.~   "
23662|NCT02747459|"~     The purpose of Sensory Supported Swimming is to provide a sustainable, low cost recreational~     swim program for children with ASD. A secondary purpose is to train general recreation~     providers and swim instructors to meet the unique needs of children. Specific aims include~     both program development and research aims as described below.~      Specific Aims:~      1. Provide more opportunities for families of children with ASD to access a recreational~     swim program at low cost. (program development) 2. Increase the capacity of swim instructors~     and general recreation providers working with children with ASD. (Research) 3. Increase~     physical activity for children with ASD in a way that is a good match for their individual~     sensory needs. (Research) 4. Increase safety among children with ASD in and around the water~     so they and their families can swim safely. (Research) 5. Transition swimmers with ASD from~     a learn-to-swim program to an inclusive swim team. (Program Development) Hypotheses~        1. The Sensory Supported Swim Program will increase physical activity of children with~          ASD.~        2. The Sensory Supported Swim Program will increase safety of children with ASD in and~          around the water.~        3. The Sensory Supported Swim Program will increase the capacity of general recreation~          providers and swim instructors to serve children with ASD.~   "
23663|NCT02747446|"~     The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as~     acacia honey or a fructose:glucose mixture will be assessed in a group of healthy male~     volunteers. Primary outcome is plasma total triglyceride concentrations after ingestion of~     standardized breakfast and lunch containing 25% energy as honey or fructose:glucose mixture;~     secondary outcome is glucose tolerance and suppression of endogenous glucose production~     after ingestion of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose~     mixture diets will be compared to results obtained with a weight-maintenance, isocaloric~     diet in which starch is substituted for honey or fructose:glucose mixture~   "
23667|NCT02747394|"~     Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits~     that interfere with learning, socialization and emotion regulation. Extensive research~     focused on the animal models of FXS show that targeted pharmacological agents can normalize~     synaptic connectivity and reverse cognitive and behavioral deficits. This translational work~     has led to multiple national and international controlled trials in humans with FXS now~     underway. However, in contrast to the heavy focus on medication treatments, there have been~     no controlled trials to empirically-validate cognitive or behavioral interventions for FXS.~     The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate~     the efficacy of Cogmed, a cognitive training program proven to enhance working memory and~     executive/frontal function in a variety of clinical populations. Demonstration of effective~     Cogmed training for FXS would represent a major advance in the field, one that may also~     generalize to other forms of intellectual disability. Furthermore, it is critical to~     determine whether the targeted pharmacological treatments can accelerate learning and~     cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for~     testing hypotheses focused on combined efficacy of medication and cognitive training.~   "
23668|NCT02747381|"~     This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on~     the the pulmonary function of adult asthmatic Egyptian patients~   "
23669|NCT02747368|"~     The aim is to study the use of Ocusweep system especially in driving health evaluation and~     compare the results produced by Ocusweep system to those of conventional devices. The main~     focus is in patients suffering from wet age-related macular degeneration. The study aims to~     find out how frequently these patients do not meet the European Union health criteria of~     safe driving and how Ocusweep finds these patients from a population of patients being~     treated in a busy medical retina clinic. The tests of Ocusweep system are compared against~     conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests~     showing anatomical changes related to wet age-related macular degeneration (optical~     coherence tomography, fundus photography and fluorescein or indocyanine green angiography).~   "
23670|NCT02747355|"~     In adrenal tumors, the investigators will examine if there is any correlation between WIESS~     criteria, prognosis of the tumor, and the different labeling index of the following~     proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN,~     SEMAPHORIN-3A.~   "
23671|NCT02747342|"~     This is a multicenter, dose-escalation phase 1 trial to evaluate the safety and tolerability~     of SHR3680 given orally to subjects with metastatic castration-resistant prostate cancer~     (mCRPC) as monotherapy.~   "
23672|NCT02747329|"~     The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience~     V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after~     implanting in relatively high bleeding risk patients with coronary artery disease using OCT.~   "
23673|NCT02747316|"~     Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk~     for iron deficiency. Studies in our laboratory have shown that this is mainly the result of~     reduced dietary iron absorption because of increased hepcidin concentrations. During~     pregnancy, women have a large increase in iron needs because of the expansion of maternal~     blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive~     development. Whether maternal adiposity impairs absorption and transfer of iron to the~     fetus, and thereby increases risk of iron deficiency in the mother and the infant is~     unclear.~   "
23674|NCT02747303|"~     The objective is to to compare 2 mm vs 0 mm PTV margins with respect to local PFS and risk~     of radionecrosis when treating intact brain metastases with LINAC-based frameless SRS~   "
23675|NCT02747290|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in~     prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD~     will be injected intravenously. Visual and semiquantitative method will be used to assess~     the PET/CT images.~   "
23676|NCT02747277|"~     This observational study aims at finding out if individual with autoimmunity exhibit~     increased numbers of B cells that express two types (instead of one type) of antibodies, and~     if B cells of individuals genetically susceptible to autoimmunity display defects in the~     biological process of tolerance, which removes B cells that participate in autoimmunity.~   "
23677|NCT02747264|"~     The purpose of the Electronic Patient Self-Reporting of Adverse-events: Patient Information~     and aDvice (eRAPID) programme is to determine whether eRAPID (an online system for patients~     to self-report symptoms and side effects) can enhance patient care and improve the safe~     delivery of cancer treatments. The investigators hypothesise that patient symptoms will be~     detected earlier with more timely admissions and a reduction in overall hospital contacts.~     It is predicted that staff will save time recording symptoms and side effects and will be~     able to focus attention during clinical contacts on more severe side effects. eRAPID is a~     cost-effective approach to supporting patient self-management and reducing hospital/General~     Practitioner (GP)/community contacts.~      The majority of the research will be run with systemic patients. This particular part of the~     research is a feasibility study in radiotherapy (RT) patients to test the platform in a~     different patient group.~   "
23678|NCT02747251|"~     This study evaluates the addition of a high dose of simple home-based elastic band~     strengthening exercises to usual care in patients with subacromial impingement syndrome.~     Half of the participants receive instructions in simple home-based elastic band~     strengthening exercises in addition to usual care, while the other half receive usual care.~   "
23679|NCT02747238|"~     The investigators believe that ultrasound guided CSE technique will help junior resident~     rotating for the first time on the labor and delivery floor to place more accurately the~     epidural needle in the midline position as compared to placing the epidural needle via~     palpation of anatomical landmarks. This will result in increased ability to place the spinal~     component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline~     placement of the epidural catheter, and increase the likelihood of adequate symmetrical~     labor analgesia/anesthesia.~   "
23767|NCT02745262|"~     The main objective of the study is to evaluate the overall survival and disease-free~     survival in breast cancer patients under 40 years old. They underwent controlled ovarian~     stimulation (COS) for fertility preservation versus women of the same age, type and stage of~     breast cancer, who have not been subjected to COS.~   "
23680|NCT02747225|"~     Previously published studies have indicated that there exist difference in electrical~     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and~     adjacent normal tissue, which will be useful in the early detection of cancers. However the~     EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo~     were published. The purpose of this study is to in vivo measure the electrical properties of~     the malignant tissues.~   "
23681|NCT02747212|"~     Previously published studies have indicated that there exist difference in electrical~     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and~     adjacent normal tissue, which will be useful in the early detection of cancers. While the EP~     informations of cancer tissues are not sufficient enough. The purpose of this study is to~     measure the electrical properties of the excised malignant tissues obtained from cancer~     surgeries.~   "
23682|NCT02747199|"~     This is a prospective, non-randomized, single center clinical trial to assess neointimal~     coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of~     12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using~     OCT and CAS~   "
23683|NCT02747186|"~     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at~     equal dosages, and a lower dosage of the buffered drug might be used with an effect equal to~     higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No~     published data exist comparing buffered local anesthetics at lower drug concentrations to~     current dosages commonly used in dental and oral surgical procedures~   "
23684|NCT02747173|"~     Prospective observational study to assess bone predictive biomarkers for TKI response in RCC~     patients with bone metastasis and HRQoL with TKI in these patients as well as the~     sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and~     versus CT in the assessment of metastatic lesions at bone level and at other sites.~   "
23685|NCT02747160|"~     The purpose of this study is to examine the feasibility and acceptability of and patient~     adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety~     in older adults (65 years and older) with cancer and their primary informal caregiver. This~     study will also examine whether the intervention has a clinically significant impact on~     patient anxiety (primary outcome) and depression, distress, and quality of life (secondary~     outcomes).~   "
23686|NCT02747147|"~     Prospective, randomized, single-center study to evaluate the ability of the device to~     collect good quality blood samples from patients with peripheral IV access over the length~     of their stay.~   "
23687|NCT02747134|"~     In the present study researchers aim to investigate the effectiveness of an intervention~     combining emotion regulation and mindfulness skills in a single 10-week program. A total of~     75 individuals with major depressive disorder (MDD) diagnosis in complete or partial~     remission participated in this randomized controlled trial (RCT) comparing an intervention~     including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program.~     After treatment, participants were followed for a 1-year period. Researchers results~     indicate that ER+M was not more effective than the treatment used with the control group in~     preventing depression relapse. Participants allocated to the ER+M group showed a significant~     decrease on global psychiatric symptoms, whereas those in the control group did not. Further~     studies are needed in order to better determine the combined effects of mindfulness and~     behavioral activation.~   "
23688|NCT02747121|"~     External inspections are widely used as means to improve the quality of care. Despite their~     widespread use, there is limited knowledge about whether and how they affect the quality of~     care. This study uses inspection with detection and treatment of sepsis in hospitals as a~     case to evaluate the effect of inspections on the quality of care and to explore how~     inspections affect the hospitals.~   "
23689|NCT02747108|"~     This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and~     brief counseling about screening test results on weight and key health behaviors among~     Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of~     two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test~     Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood~     sugar levels. Participants will receive brief counseling about the results from their~     primary care provider or someone authorized to speak on their behalf. Participants randomly~     selected for the Brochure Group will review a handout from the VA National Center for Health~     Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All~     participants will be asked to complete a survey prior to study group assignment, immediately~     after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.~   "
23690|NCT02747082|"~     The aim of this randomized clinical trial is to compare the antibacterial effects of 1%~     sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth~     with apical periodontitis (AP).~   "
23691|NCT02747069|"~     This study will evaluate the accuracy of both an electronic stethoscope and~     electrocardiogram (ECG) to evaluate heart rate in neonatal patients in the delivery suite.~      The initial phase of this study will assess the electronic stethoscope use on stable~     neonates on the neonatal care prior to use in the delivery room.~   "
23692|NCT02747056|"~     The research aims at clarifying the impact of autism on personal identity in adulthood. Two~     studies will be made in order to compare adults with autistic spectrum disorders without~     intellectual deficiency and controls. In the first study (Study A), the investigators will~     ask subjects to tell autobiographical memories and to specify their characteristics by~     answering focused questions. In the second study (Study B), the investigators will ask~     subjects to say the self statements which define them. Then, subjects will have to tell and~     to specify the characteristics of the autobiographical memories linked to these self~     statements.~   "
23693|NCT02747043|"~     This trial is designed to determine what effects the human body has on the investigational~     medicine, ABP 798, and what effects the body has on the investigational medicine after you~     have been given it, and if this is comparable to what is seen for the licensed medicine,~     rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.~      This study will assess if the investigational medicine is safe and effective in treating CD~     20 positive B-cell non Hodgkin lymphoma.~   "
23694|NCT02747030|"~     In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the~     entire retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema~     and neovascularization. The development of a microneedle and surgical stabilizer made it~     possible to perform a prolonged (10 minutes) retinal vein cannulation with infusion of~     Ocriplasmin. Ocriplasmin has the advantage over tissue Plasminogen Activator (tPA) that it~     already is an active enzyme and a strong fibrinolyticum. This study aims to investigate the~     feasibility and safety of local intravenous Ocriplasmin for CRVO.~   "
23695|NCT02747017|"~     The primary objective of this observational study is to estimate the 90-day response rates~     to treatment for a first episode of C. difficile infections (CDI) in adult transplant~     recipients.~   "
23696|NCT02747004|"~     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus~     tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive~     (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.~   "
23697|NCT02746991|"~     This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to~     evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)~     insert for the management of subjects with chronic non-infectious uveitis affecting the~     posterior segment of the eye. Patients will be randomized to receive either a sham injection~     or the FAI insert and will be observed for three years following treatment.~   "
23698|NCT02746978|"~     Shepherd Center is bringing a more patient-centered focus to educational, peer-support, and~     technology resources offered to patients with spinal cord injury and their families and is~     evaluating these changes.~      Approximately 740 patients have provided information about healthcare utilization following~     inpatient rehabilitation. This information will help Shepherd Center staff follow~     utilization trends and plan programs targeted at the high-use areas.~   "
23699|NCT02746965|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety among schizophrenia patients. Half of the participants will be randomized to MST~     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).~   "
23700|NCT02746952|"~     The purpose of this study is to evaluate the safety and tolerability of several doses of~     UCART19 in patient with relapsed / refractory (R/R) acute lymphoblastic leukaemia (ALL) or~     chronic lymphocytic leukaemia (CLL)~   "
23701|NCT02746939|"~     The study is designed to examine whether curriculum, designed in partnership with teachers~     at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is~     able to influence the behavior and health literacy of students. This information will be~     collected in surveys before and after the students are given the curriculum during the~     school day.~   "
23702|NCT02746926|"~     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted~     for each test and every subject will test all 3 different formulations. After swallowing~     tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14~     days, subjects will take a different formulation of tafamidis and tafamidis blood~     concentrations will be measured periodically for 8 days. After another 14 days, the last~     formulation will be tested in the same way.~   "
23703|NCT02746913|"~     The purpose of this study is to compare two methods for assessing patients with pelvic organ~     prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely~     accepted and well-studied method for diagnosing occult stress urinary incontinence~     preoperatively, but an ambulatory pessary trial is a less expensive option that is available~     to a wider group of practitioners and evaluates patient while they are engaged in their~     daily activities.~   "
23704|NCT02746900|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. In singleton gestations a short cervical length (CL)~     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.~      Different strategies have been adopted for prevention of SPTB. Growing interest has focused~     on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use,~     does not require anesthesia, can be used in an outpatient clinic setting, and it is easily~     removed when necessary. However, a recent systematic review and meta-analysis of randomized~     clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of~     the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal~     outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with~     short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women~     with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior~     SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized~     studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical~     cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7~     However, even if the statistical significance were not reached, they found a reduction in~     SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs~     31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in~     singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).~      Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in~     prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without~     prior SPTB.~   "
23705|NCT02746887|"~     This is a follow-up cohort study of 8 years old children born preterm at Seoul National~     University Children's Hospital in Korea from 2008-2009.~      The children will visit outpatient clinics for examinations regarding growth, obesity and~     other risk factors related to metabolic syndrome.~      The purpose of this study is to compare growth and risk factors of metabolic syndrome among~     children born preterm and children born healthy term at school age~   "
23718|NCT02746718|"~     A breach of respiratory function may be one of the elements more or less early or~     predominant clinical picture of neuromuscular diseases. It is considered that the~     obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic~     respiratory insufficiency, approximately 7% due to a neuromuscular disease. The frequency~     and type of impairment are dependent on the underlying pathology.~      The neuromuscular restrictive respiratory failure (IRR) remains partially unknown~     pulmonologists, especially because the signs of muscle weakness are sometimes difficult to~     detect. However, respiratory diseases are a major concern in neuromuscular diseases because~     they can have an impact both on sleep (not sleep, ...) on the daily activities~     (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients.~     Moreover, they represent a significant morbidity and mortality factor. Chest tightness may~     in some cases reveal the disease and thus constitute the chief complaint of a patient with a~     neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical~     symptoms in about 30% of patients.~      An algorithm was developed to guide practitioners and help them in their diagnostic approach~     to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does~     not allow precise identification of the neuromuscular causes.~      At the patient level, this can have an impact by extending the time before placing a~     diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there~     are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of~     practitioners with regard to the particular Pompe disease and neuromuscular diseases in~     general may be beneficial to patients.~      This study aims to:~      i) awareness pulmonologists to the possibility of neuromuscular an IRR.~      ii) characterize the frequency of neuromuscular origin of IRR in a broad population of~     patients with concomitant signs muscle weakness.~      iii) reduce the time to diagnosis by directing patients to neuromuscular reference center~     early.~   "
23706|NCT02746874|"~     More than 300,000 total knee joint replacement surgeries are performed per year in the~     United States and safe, effective management of post-operative pain in these patients, often~     elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be~     challenging and often require a multidisciplinary, multimodal approach. Opiates have been a~     mainstay of treatment in the post-operative period with varying degrees of success and~     complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled~     pain inhibits early mobilization and hinders post-operative physical therapy.~      A new paradigm for treating post-operative pain following total knee replacement may be the~     use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the~     knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the~     anterior capsule and thereby decrease post-operative pain. There are several publications~     that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis~     however the use of RFA in the preoperative management of pain in patients undergoing total~     knee joint replacement has not been investigated.~      The aim of this study is to determine if patients undergoing unilateral total knee~     replacement obtain any post-operative pain relieving benefits from C-RFA of the articular~     sensory nerve supply when performed prior to surgery, as compared to sham controls who~     receive only local anesthetic injections of these same nerves without the benefit of~     ablation treatment.~   "
23707|NCT02746861|"~     The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African~     American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to~     patients with poorly-controlled diabetes.~   "
23708|NCT02746848|"~     For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson~     syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal~     surgery and others, it is important that short time treatment with minimal side effect~     should be considered. This study is a prospective clinical trial to use Amniotic Membrane~     Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing~   "
23709|NCT02746835|"~     Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary~     falls prevention program. This program consisted on an adapted exercise program.~      Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.~      At the end of this program, measures of physical condition and of self-efficacy were~     repeated to determine its related-effect.~   "
23710|NCT02746822|"~     Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and~     aspiration of thrombus material from the infarct related coronary artery will be included.~     Both cellular and non cellular content of the thrombus will be examined with morphological~     and immunohistochemical methods and related to time from onset of symptoms to PCI, as well~     as to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal~     molecules will be performed. In addition, peripheral venous blood samples will be drawn and~     analyzed for signalling molecules and corresponding mRNA expression in circulating~     leukocytes.~   "
23711|NCT02746809|"~     The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R~     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic~     aortic stenosis who are considered at high or extreme risk for surgical aortic valve~     replacement.~   "
23712|NCT02746796|"~     The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in~     unresectable advanced or recurrent gastric cancer (including esophagogastric junction~     cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate~     the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur~     / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine +~     Oxaliplatin). In part 2, either SOX or CapeOX therapy will be selected as chemotherapy for~     the study. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy~     in comparison with chemotherapy alone.~   "
23713|NCT02746783|"~     This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2014~     on the immune response to improve the investigators understanding of cellular and humoral~     immune responses induced. The scope of this study is to determine the profile of cellular~     activation and antibody production in the ageing immune system following flu immunization.~      This study will enroll 100 male or female subjects ≥65 year old. These persons will be~     deemed to be  at risk  in case of influenza infection and should be vaccinated according~     to Swiss Federal Office of Public Health. A medical doctor from the CHUV will inform the~     patients about the present study and ask them whether they would be willing to participate~     in the study.~      All subjects will be distributed between the two groups according to a computer-generated~     randomization sequence. The randomization will be done in blocks to ensure balance across~     groups. The participants and site staff will not be blinded due to the different~     administration assignments.~      Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP®~     manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012~     (H3N2); B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4~     and 24 weeks after vaccination.~      Study duration per volunteer is 6 months after vaccination.~   "
23714|NCT02746770|"~     Spanish population with unilateral peripheral vestibular disorders.~   "
23715|NCT02746757|"~     The study was designed to investigate whether glucagon like peptide-1 is a mediator of~     protection of endothelial function induced by remote ischemic conditioning in~     ischemia-reperfusion~   "
23716|NCT02746744|"~     A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early~     Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.~   "
23717|NCT02746731|"~     The purpose of this study is to determine whether a combined cardiorespiratory and~     strengthening training prior to colorectal surgery decreases the rate of surgery-related~     complications.~   "
23719|NCT02746705|"~     This study will test the tolerability and preliminary efficacy of transcranial direct~     current stimulation (tDCS) combined with a cognitive training program, remotely-delivered~     using a telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will~     evaluate the efficacy of tDCS to evaluate two of the most debilitating symptoms of MS:~     cognitive impairment and fatigue.~   "
25246|NCT02726737|"~     The purpose of this prospective, randomized, double blind study was to evaluate the effect~     of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior~     alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic~   "
23720|NCT02746692|"~     Sports medical experts recommend considerable amounts of regular physical activity in order~     to improve strength, motor control, endurance and flexibility. However, only a small share~     of the population is able to meets the corresponding international guidelines. One reason~     for this is supposed to consist in private scheduling problems and the high time~     expenditure. Against this background, high-intensity intermittent training methods with~     short durations have become popular.~      The present study aims to evaluate the effectivity of a high -intensity functional circuit~     training (the FIT15 program) in improving body function.~      Thirty healthy individuals will be included in the randomized, controlled two-armed parallel~     group trial. In the intervention group, the participants will perform the FIT15 program, a~     group-based high-intensity circuit training based on functional movement patterns (e.g.~     squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three~     times a week, each 15 minutes for a total of six weeks. In the control group, the~     participants will exercise three times a week (in total for six weeks) at moderate intensity~     on an ergometer according to the cardiopulmonary exercise guidelines of the American College~     of Sports Medicine. Outcomes assess prior and following the six-week training period~     encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity~     (spirometric exercise testing including lactate analysis), postural control (force plate),~     maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and~     psychometric variables (e.g. physical activity readiness questionnaire).~   "
23721|NCT02746679|"~     The purpose of this study is to determine whether mindfulness based stress reduction are~     effective on improve anxiety, depression and quality of life in women with intrauterine~     adhesion~   "
23722|NCT02746666|"~     The purpose of this study is to investigate the impact of pharmacist behavioral~     intervention's influence on breast cancer patients' quality of life. Croatian randomized~     controlled trial. Targeted population: general population of breast cancer patients under~     the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23~     questionnaire result from the baseline to after 3 week cycle.~   "
23723|NCT02746653|"~     The use of the TroClose1200™ will be done in at least one 12mm planned access port per the~     TroClose1200™ Instruction for Use. The procedure will be performed routinely. Adverse Events~     and device malfunctions, if any, will be recorded. Subjects will be hospitalized in~     accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4~     days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months)~     in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24~     months visit, the hernia signs will be evaluated by ultrasound.~   "
23724|NCT02746640|"~     In case of a cardiac arrest it is very important to quickly provide high quality~     cardiopulmonary resuscitation (CPR). For reasons of patient safety the investigators want to~     assess the frequency, the quality and the outcome of cardiopulmonary resuscitations in the~     Inselspital Bern.~   "
23725|NCT02746627|"~     Problems with diabetes management in adolescents with type 1 diabetes are common - occurring~     at rates as high as 93% - and have serious health consequences, including poor blood sugar~     control and risk for later complications. Therefore, the investigators proposed to test a~     positive psychology intervention for adolescents with type 1 diabetes aimed at increasing~     motivation for diabetes management; specifically, to increase the frequency of blood glucose~     monitoring. This intervention will boost positive mood in adolescents (age 13-17) through~     tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a~     way to improve motivation for diabetes management. In addition, this study will explore the~     use of technology, by comparing telephone-administered vs. automated text-messaging versions~     of the intervention, to determine which mode of delivery is more appealing, convenient, and~     beneficial for adolescents in managing their diabetes.~      Participants and parents will complete questionnaires on mood and diabetes management during~     a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes~     management will be collected from participants' electronic medical records.~   "
23726|NCT02746614|"~     People with intellectual and developmental disabilities (IDD) usually present limitations at~     adaptive behavior and motor skills, which lead to limitations/barriers in the daily~     independent functioning of this population. The main goal of this research is to analyze the~     efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an~     assessment of their progress both in adaptive behavior competences and motor proficiency~     skills.~   "
23727|NCT02746601|"~     The purpose of the research is to identify the prevalence of preconception health (PCH) risk~     factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or~     not a client-driven electronic preconception health risk assessment tool My Health~     eSnapshot, for use during healthcare visits, will increase preconception health knowledge~     and behaviour change among women of reproductive age (15-49 years).~   "
23728|NCT02746588|"~     To be diagnosed with recurrent miscarriages, a couple might have a child, however~     experiences three or more miscarriages, primarily this happens during the first trimester.~      These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue~     increases the risk of complications as infection and/or adhesions, known as asherman~     syndrome, which may result in subfertility.~      Recently chronic infection in the endometrium has been proposed to contribute to the~     condition, as protocols including treatment with antibiotics have led to birth at term for~     some of these women.~      Using the very minimal invasive office hysteroscopy, the investigators aim to describe the~     uterine cavity in patients diagnosed with recurrent miscarriages regarding both~     abnormalities in the endometrium and chromic infection.~   "
23741|NCT02746419|"~     This study will test the safety and efficacy of the Vessix Renal Denervation system in the~     reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).~   "
23742|NCT02746406|"~     In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will~     be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry~     method. In the home setting a human factor/usability study will be conducted to measure the~     subject's ability to perform a successful SMIP assessment at full and empty bladder with the~     Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a~     clean intermittent catheter (CIC).~   "
23729|NCT02746575|"~     Perioperative cardiac adverse events [heart injuries caused by general anesthesia and~     surgical procedures] are a significant public health issue, with more than 60,000 deaths per~     annum in patients having surgery for non-heart related issues. There are virtually no~     evidence-based medical strategies for effective prevention of these events. Preoperative~     drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy~     with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used~     for high blood pressure, and aspirin have all been investigated as potential mitigating~     treatments, but without positive clinical outcomes and, in some cases, creating more~     hemodynamic instabilities that result in heart injury. In light of this, investigators~     propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs~     immediately after surgery and to assess the value of high-sensitivity cardiac troponin level~     testing of the blood in predicting those patients who would benefit most from perioperative~     beta blocker therapy.~   "
23730|NCT02746562|"~     The purpose of this study is to compare conventional fresh embryo transfer with a freeze~     all and transfer later strategy in assisted reproductive technology in terms of ongoing~     pregnancy rates, live birth rates as well as perinatal outcomes.~   "
23731|NCT02746549|"~     In this study, investigators want to compare the accuracy of two methods to measure renal~     perfusion by MRI spin labelling technique: the first measurement done with the 1.5 T MRI~     versus the second one obtained with the 3.0 T MRI (Siemens MRI device).~   "
23732|NCT02746536|"~     Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present~     dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when~     performing their activities of daily living (ADLs). The slow chest compression (SCC)~     technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral~     muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects~     of SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests.~      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient~     pulmonary rehabilitation program in Florianopolis, Brazil~      Subjects: Patients with COPD (GOLD B-D).~      Interventions: Patients will randomly receive or not the SCC after six-minute step test~     (6MST-SCC and 6MST-NonSCC) and after six minute walk test (6MWT-SCC and 6MWT-NonSCC)~      Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will~     be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1~     minute after the tests, the dyspnea score will be assessed. The physiological responses and~     the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after~     them.~   "
23733|NCT02746523|"~     To investigate long term affects of multiple concussions on the cognition, balance,~     proprioception, and biomarkers in retired National Hockey League players~   "
23734|NCT02746510|"~     Background:~      Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red~     flags for syndromic forms of schizophrenia remain poorly documented.~   "
23735|NCT02746497|"~     As a natural part of the menopause the ovaries production of sex hormones declines. This can~     lead to different menopausal related symptoms. About two-thirds of postmenopausal women~     experience hot flushes and 10-20% find these hot flushes very stressful.~      The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal~     symptoms; in particular hot flushes. The study will be a randomized controlled trial.~     Primary outcome is change in hot flushes. Secondary outcome is change in other menopausal~     related symptoms.~   "
23736|NCT02746484|"~     The Ability research project, funded in Italy within the Smart Cities and Smart Communities~     funding program (MInistry of University and Research, Operational Regional Programme,~     Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development~     2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart~     Health Community able to provide innovative trajectories for people with cognitive~     impairment, putting them at the core of a continuous and intertwining treatment and support~     from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with~     special focus on home-based care.~      Within this framework of the Ability project the investigators test the efficacy of the~     home-based motor-cognitive rehabilitation program delivered with two different approaches:~     the Ability platform versus the usual care program~   "
23737|NCT02746471|"~     The Reveal LINQ Registry will generate reliable long-term real world data of product~     performance, economic valuation, site-of-service procedural information.~   "
23738|NCT02746458|"~     The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be~     conducted in a patient population of individuals recovering from a traumatic diaphyseal~     fracture of the femur. Although the intervention can be used for any patient with muscle~     weakness following trauma, the persistent thigh weakness that follows a femur fracture~     provides a perfect model for evaluating the effectiveness of the REPAIR protocol.~   "
23739|NCT02746445|"~     The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic~     EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No~     active MeRT treatment will be performed in this study.~   "
23740|NCT02746432|"~     Research Problem:~      Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.~      factors for both post-operative complication and possible disease recurrence. Colorectal~     cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males.~     Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of~     death in these patients. Despite the new era of laparoscopic surgery, still surgical stress~     is present and equally traumatic to the conventional open colorectal resection, earlier~     studies showed no major differences in post-operative inflammatory and immunological~     reactions. The previous studies revealed the anti-inflammatory effects of the~     hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in~     cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative~     inflammation.~      The hypothesis is Can intraoperative hyper-insulinimic euglycemic infusion reduce post~     operative inflammation and immunomodulation in colon cancer patients undergoing a curative~     surgery?~      Research methodology Triple blinded randomized controlled study with estimated sample size~     of 144 patients of non-metastatic colorectal cancer patients operated at King Saud~     University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients~     Consented will undergo computer randomization to receive intraoperative hyper-insulinimic~     normoglycemic infusion (experimental) or standardized insulin sliding scale and saline~     (control). A common preoperative and postoperative pathway with standardized management and~     pain control in both groups.~      Outcomes will be measured via a battery of laboratory test consist of routine labs,~     inflammatory markers and immunological markers to be repeated at fixed timed intervals. All~     patients will be followed by regularly for 5 years.~      Research objectives~      Primary outcomes to examine:~        -  The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in~          patients undergoing colorectal cancer surgery.~        -  The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion~      Secondary outcomes:~        -  Thirty days post-operative morbidity.~        -  Overall survival rate.~        -  Disease-free survival rate.~   "
23743|NCT02746393|"~     The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized~     Controlled Trial (RCT) that collects survey data and non-invasive biological data from~     caregivers and children visiting a pediatric urgent care center. Families will be randomized~     according to a pre-determined randomization schedule into one of two social needs-focused~     interventions (the Health Advocates Program or a 211 Information active comparator arm). All~     patients in the study will be followed over a six month period to capture information about~     changes in social needs, health and health care utilization.~   "
23744|NCT02746380|"~     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in~     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.~   "
23745|NCT02746367|"~     The purpose of this study is to validate a set of signatures, based on a panel of proteomic~     markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive~     episode.~   "
23746|NCT02746354|"~     The objective of this study is to engage patients with chronic pain and other key~     stakeholders in an iterative process of pilot-testing a validated patient generated~     instrument, the Measure Yourself Medical Outcome Profile (MYMOP), to support primary care~     encounters and provide a direct comparison between a strategy of incorporating patient~     reported outcomes into the package of care for complex pain patients and usual care. The~     specific aims of this phase of the project are to: 1) adapt the MYMOP for use in the primary~     care setting well-integrated into everyday practice flow, and 2) evaluate whether the~     utilization of the MYMOP data in routine primary care encounters results in improvements in~     patient symptoms and functioning over time as well as increased satisfaction with the visit~     for patients and primary care providers. To achieve Aim 2, the investigators will compare~     the reported outcomes and health care utilization from participating patients in this study~     for whom the MYMOP-based instrument will be used in routine clinical care to a matched group~     of chronic pain patients who will not receive the MYMOP-based assessment but will otherwise~     have similarly collected data. This also allows us to evaluate of the extent to which use of~     the tool adds patient-centered information to more conventional instruments. In addition to~     these two aims, for a third aim, the investigators plan to collect qualitative data from~     patients, their family members, Kaiser Permanente Northwest (KPNW) health care providers,~     and KPNW administrators to better understand the needs of this subpopulation of patients.~   "
23747|NCT02746341|"~     Evaluate the clinical progression in patients with MPS IIIA who are untreated with any~     investigational product and to obtain standardized assessments: neurocognitive, behavioral,~     sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their~     families.~   "
23748|NCT02746328|"~     This is a multiple site, proof of concept feasibility study to describe the effect of~     GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with~     ER+/AR+ breast cancer.~   "
23749|NCT02746315|"~     This trial is conducted in China. The aim of this trial is to assess the safety and~     tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects~   "
23750|NCT02746302|"~     This trial is conducted in China. The aim of this trial is to assess the safety and~     tolerability of HS-20004 in healthy Chinese subjects.~   "
23751|NCT02745470|"~     The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of~     brain activation and connectivity obtained by functional magnetic resonance imaging in lean~     and obese type 2 diabetes~   "
23752|NCT02745457|"~     Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel~     diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the~     literature that body composition, composed of fat mass and lean mass is altered in children~     with IBD compared with controls. Evidence regarding the effect of different therapeutic~     approaches on body composition in children with IBD is scarce and inconsistent. Furthermore,~     most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for~     body composition assessment, while information on the usefulness of air displacement~     plethysmography (ADP) for this assessment is lacking.~      Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and~     at various intervals during follow up.~      Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider~     Children's Hospital.~      Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative~     colitis (UC).~      Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and~     lean mass at diagnosis and during treatment.~      Secondary outcome measures: Correlation of body composition to skin fold, mid arm~     circumference measurements, BMI, inflammatory markers, gender, disease activity and physical~     activity.~   "
23753|NCT02745444|"~     The key objective of this pilot study is to assess the molecular mechanisms of renal~     pre-conditioning by a one-week low-calorie diet in humans.~      The protective effect of the low-calorie diet and also of the protein-restriction in donor~     on transplant qualities and functions in receptor will also be investigated.~      Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome~     through tissue samples as well as blood samples for comparison of low-calorie diet,~     protein-restriction and no-diet groups.~   "
23754|NCT02745431|"~     The current study aimed to investigate oxytocin effect on the response after the experience~     of being liked or disliked.~   "
23755|NCT02745418|"~     Caucasian male and female participants age 18 years of age and older will be enrolled in~     this study if they have known birch or peanut allergies or known to be non-atopic.~     Participants will undergo skin testing to confirm their allergies if not completed in the~     last 12 months. Medications and medical history will be captured with a focus on atopic~     disorders. Participants will undergo birch and peanut patch testing to assess penetration~     and if potential correlation exists with filaggrin genotyping and phenotyping. Blood samples~     will be drawn from participants and DNA isolated for genotyping of null mutations in~     filaggrin.~   "
23756|NCT02745405|"~     This study examined how wearing a fat suit might lead individuals to experience the negative~     effects of weight based stigmatization, including psychological, behavioral, and~     physiological consequences. It also aimed to test using the fat suit as a possible~     intervention tactic to reduce weight stigma.~   "
23757|NCT02745392|"~     This is a randomized, double-blind, multi-center, parallel-group study designed to compare~     the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle~     systems to placebo.~   "
23758|NCT02745379|"~     In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal~     fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the~     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft~     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by~     cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.~   "
23759|NCT02745366|"~     In this study the buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat~     pad tissue of the patients receiving posterior mandible augmentation. In the test group the~     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft~     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The control group receivesFDBA~     (without any cells)+PRF. In all the groups the combination are placed between the recipient~     site and the block graft obtained from lateral ramus. The results will be evaluated by cone~     beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.~   "
23760|NCT02745353|"~     The purpose of this study is to compare the effect of naloxegol versus the patient's usual~     care in treating opioid-induced constipation, as well as the effect on the patient's quality~     of life and how much pain is experienced. Also, the purpose of this study is to compare~     whether treatment with naloxegol versus usual care has any impact on the number of hospital~     or clinic visits or telephone calls to the patient's physician that are related to~     constipation, and to determine the patient's preference for continuing to receive naloxegol~     as treatment for opioid-induced constipation.~   "
23761|NCT02745340|"~     Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide.~     It has been published in small trials or case series that the addition of acetate is~     associated with a rise in nitric oxide production of vascular smooth muscle cells,~     endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore~     clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure~     drops, induction of proinflammatory cytokines and activation of complement and leukocytes~     have been described with acetate.~      Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis),~     Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects.~     Both dialysate additives (citrate and acetate) are commercially available and are used world~     wide in dialysis centers.~      The investigators hypothesize that substitution of acetate by citrate reduces the~     cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity~     and Augmentation index) and might improves quality of life in the participants. Furthermore~     the investigators speculate that citrate in the dialysis solution could reduce systemic~     inflammation in the participants of the study.~   "
23762|NCT02745327|"~     The purpose of this study is to assess the impact of small intestine bacterial overgrowth~     (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.~   "
23763|NCT02745314|"~     BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in~     the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with~     poor prognosis, the most frequent cause of heart surgery in the elderly and associates high~     health costs. No variables have been identified as determinants of morbidity and mortality~     of these patients and there are not algorithms developed for treatment decision-making in~     this particular population. The FS as a functional reserve indicator could be a prognostic~     and interventional treatment tolerance marker, and should be included in the selection of~     patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological~     substrates among which an inflammatory state associates poor prognosis.~      OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the~     prognosis of elderly patients with severe symptomatic AS representative of clinical~     practice. In addition, to examine the contribution of an inflammatory state to the~     relationship of FS with the prognosis of severe, symptomatic AS.~      METHODS .- Prospective study during 12 months of 200 patients > 74 years old with severe~     symptomatic AS. During the index visit the main clinical characteristics will be recorded~     and in addition we will perform a comprehensive geriatric assessment, FS assessmet according~     to Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional~     weight loss) and determination of inflammatory markers (C-reactive protein and~     interleukin-6). During follow-up, measures of functional impairment (basic and instrumental~     activities of daily living, walking speed and timed set up & go test), hospitalizations,~     death and quality of life will be determined.~   "
23764|NCT02745301|"~     To assess the persistence of bladder cancer-specific biomarkers in urine collected~     pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel~     of sensitive and specific bladder cancer biomarkers will be used to establish a signature of~     disease in pre-operative patients with a positive diagnosis for bladder cancer by current~     standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these~     markers will be assessed, as well as the degree of non-specific signal attributable to other~     sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers.~     Finally, post-operative urine will be assessed for the presence of these markers. To the~     extent this biomarker panel can be determined to be specific and sensitive, it may serve as~     an indicator of the degree to which the surgical intervention successfully eradicated the~     underlying disease. The investigators also aim to assess the stability of a biomarker~     signature in urine but evaluating several patient specimens over various time points~     throughout the day.~   "
23765|NCT02745288|"~     Mandibular resection which is an important component of maxillofacial cancer surgery is an~     extremely painful procedure associated with severe sympathetic response needing high doses~     of opioids. Inferior alveolar nerve block is a common nerve block used by dentists for~     mandibular dental extractions. The aim of this trial is to study the effect of this block~     for intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral~     mandibular resection.~   "
23766|NCT02745275|"~     Canadians are living longer than ever before. However, many in our society age with long~     term chronic medical conditions which have a major impact on their need for healthcare,~     their quality of life and well-being. Encouragement of lifestyle practices which promote~     healthy aging and self-management techniques to deal with chronic disease is important in~     improving peoples' well-being~      The purpose of this study is to study the impact of peer delivered education and support for~     seniors living in the community to see if training given to other seniors improves healthy~     ageing behaviours and their health literacy.~   "
23768|NCT02746276|"~     Children with severe malnutrition who are admitted sick to hospitals have a high mortality,~     usually because of infection. All children with severe malnutrition admitted to hospitals~     are treated with antibiotics. However, policymakers are not sure that the current~     antibiotics are the most effective. It is possible that the antibiotics that are currently~     used as second-line should be used first. Finding this out will need a large trial comparing~     different antibiotics. To prepare for such a trial the investigators first want to make sure~     that the doses given are correct for malnourished children. The investigators also want to~     check whether malnourished children more commonly carry resistant bacteria in their feces~     than well-nourished children. The study is important because the types of antibiotics and~     the doses needed to fight infection may be different in malnourished children because of the~     changes in their body due to malnutrition and the types of bacteria present.~   "
23769|NCT02746263|"~     The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the~     treatment of acute moderate to severe pain in combination with standardized~     patient-controlled analgesia (PCA) in adult subjects following total knee replacement.~   "
23770|NCT02746250|"~     The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent~     Episodic Tension Type Headache before and after treatment with amitriptyline - and to~     compare the results with healthy individuals.~   "
23771|NCT02746237|"~     Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on~     single and multiple ascending doses of KAR5585 in healthy adults.~   "
23772|NCT02746224|"~     This is an interventional, controlled and randomized single-center clinical trial with~     patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy~     or laparoscopic low anterior resection for rectal cancer.~      All patients included in the study (study 1) are randomized into two groups (group 1A and~     group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric~     vein (IMV) and in the group 1B the surgical technique initially dissects the inferior~     mesenteric artery.~      The patients who will undergo a colorectal anastomosis will be included in the study 2 and~     will be randomized to group 2A and group 2B: in group 2A the patients will have a~     latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal~     anastomosis.~      Study hypothesis:~      Study 1: the surgical technique that initially dissects the IMV presents a greater number of~     total resected lymph nodes compared to the technique that initially dissects the IMA.~      Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome~     than termino-terminal anorectal anastomosis.~      Primary outcome measures:~        -  Study 1:To compare the total number of resected lymph nodes and the distance to the~          surgical margins between the two arms (1A and 1B).~        -  Study 2: to compare the anorectal functional outcome at 12 months after surgery or~          ileostomy closure between the two arms (2A and 2B). The anorectal function will be~          assessed by the scores of the validated Colorectal Functional Outcome Questionnaire~          (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).~      Secondary outcome measures:~        -  Study 1: to compare the duration of surgery, bleeding and need for surgical conversion~          between the two arms (1A and 1B). Another objectives are to compare the incidence of~          postoperative complications (measured by the Clavien-Dindo classification) and~          survival.~        -  Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12,~          18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and~          2B). The anorectal function will be assessed by the validated COREFO questionnaire and~          the LARS scale. The quality of life will be assessed by the validated questionnaire of~          quality of life: SF-36. Another objective is to compare the incidence of postoperative~          complications assessed by the Clavien-Dindo classification and the incidence of~          anastomotic leakage.~   "
23773|NCT02746211|"~     A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99)~     virus for use in other Influenza challenge studies for the development of Influenza~     vaccines, antiviral agents and to better understand the host response to Influenza~     infection.~   "
23774|NCT02746198|"~     The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and~     duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication~     therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory~     study.~   "
23775|NCT02746185|"~     The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous~     dalteparin in patients with cancer associated thrombosis. It is designed as a~     non-inferiority open label randomized multicenter trial with blinded adjudication of outcome~     events.~   "
23776|NCT02746172|"~     The aim of this research is to investigate the potential use of specific metrics in~     assessing the quality and optimising an individual's cochlear implant fitting. Assessment of~     the sensitivity and specificity of specific metrics that are potential predictors of~     inaccurate T-levels and C-levels is important to determining best methods for streamlined~     high quality fitting, providing the potential for feedback to the individual and clinic, as~     well as automated adjustments for optimisation. Ultimately the objective is to increase~     clinical capacity for managing both the installed base and new candidates for cochlear~     implantation.~   "
23777|NCT02746159|"~     The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic~     abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the~     arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and~     followed clinically for a minimum of 12 months.~   "
23778|NCT02746146|"~     The main objective of this study is to show that the systematic use of a prognostic score as~     early as possible after the initiation of dialysis in patients over 70 years of age and with~     a good prognosis at 3 years of dialysis results in an increase in the number of entries on a~     kidney transplant waiting list at 12 months after the initiation of dialysis.~      This prospective assessment is carried out as part of a historico-prospective before-after~     study in parallel with a survey of changes in national practices over the same time period~     via a here-elsewhere type study.~      Historical data (i.e the. before period) will include incident dialysis cases during the~     calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. after~     period, which is represented by the current declaration); since a preliminary study~     demonstrated that the data are comparable from 2011 to 2013, we will use the average of data~     thus obtained. Historical data will be retrieved from the REIN (The French Renal~     Epidemiology and Information Network) registry data and will be validated by investigators~     at each center.~   "
23779|NCT02746133|"~     The purpose of this study is to characterise the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
23780|NCT02746107|"~     Randomized study concerning the effect of the number of risk diagrams (with treatment +/-~     without treatment), the period of stroke risk estimation (one year or five years) and the~     target of prescription (the patient with atrial fibrillation or the physician himself,~     imagining she/he has atrial fibrillation) on the intention to prescribe or not oral~     anticoagulation.~   "
23781|NCT02746094|"~     The primary objective of this study is to evaluate changes in erectile function (EF) before~     versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy~     (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile~     Function) scores.~   "
23782|NCT02746081|"~     In patients with IDH1-R132X-mutant solid tumors treated with BAY1436032:~        1. Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended phase~          II dose (RP2D) of BAY1436032;~        2. Evaluate the pharmacokinetic (PK) properties and pharmacodynamic (PD) effects of~          BAY1436032;~        3. Look for preliminary evidence of clinical efficacy in patients treated with BAY1436032.~   "
23783|NCT02746068|"~     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the~     efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone~     marrow lesions.~   "
23784|NCT02746055|"~     To determine the prevalence of 5 specific corneal dystrophies in a subgroup of patients~     seeking refractive surgery, and to use that information to inform them and their refractive~     surgeons of the presence of the corneal dystrophies so that they may make safer choices when~     considering refractive surgery.~   "
23785|NCT02746042|"~     To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in~     the treatment of chronic rhinosinusitis (CRS) in adults.~   "
23786|NCT02746029|"~     Heart murmurs are commonly discovered in young children during clinical encounters in~     general practice. Heart murmurs might signal a structural cardiac disease that need to be~     treated, such as atrial septal defect. Thus, children with heart murmurs are routinely~     referred to comprehensive cardiac examination at a paediatric hospital department featuring~     echocardiography ('gold standard'). However, the great majority of such murmurs are innocent~     or physiological; ie., they do not represent a cardiac disorder. The prevalence of such~     innocent murmurs during routine random auscultation is estimated at 30 %.~      It would be advantageous if patients with a heart disease to a greater extent could be~     identified at the general practitioners' office:~        -  Healthy children would not be exposed to comprehensive cardiac examination~        -  The burden on the family would subside.~        -  Scarce medical resources in highly specialized departments would be better allocated,~          to the benefit of patients with real heart disease.~      The primary aim of this study is to establish the predictive value of cardiac markers in~     children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac~     ultrasound examination in general practice; b) To establish age-adjusted reference range for~     cardiac markers in children, and c) To explore aspects of cardiovascular physiology in~     children.~      The investigators will include a total of 500 children aged 4 weeks to 10 years who is~     consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for~     assessment of heart murmurs. All participants will be subjected to clinical examination,~     symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other~     biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will~     also undergo echocardiography performed by a general practitioner who has not received~     formal training in pediatric cardiology. The value of possible predictors will be assessed~     through the construction of Receiver Operating Characteristics (ROC) curves, and calculation~     of negative predictive value.~   "
23787|NCT02746016|"~     This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula~     intolerance in healthy term infants.~   "
23788|NCT02746003|"~     Background (brief):~        1. Burden:~           Excessive salinity is common in groundwater aquifers across south-western coastal~          Bangladesh. Higher adult mean systolic and diastolic blood pressure and increased risk~          of gestational hypertension has been observed among those who drank tube-well water~          with high sodium content.~        2. Knowledge gap:~           Managed Aquifer Recharge (MAR) systems, that inject freshwater into shallow aquifers,~          reduce drinking water salinity, have been successfully installed in the south-western~          area, providing year-round freshwater. However, the health benefits and risks of MAR~          water have not been measured.~        3. Relevance:~      If drinking MAR water can reduce hypertension in adults and pregnant women, while showing~     minimal risk of microbiological and chemical contamination, scale up can be considered.~      Hypothesis (if any):~      Mean systolic and diastolic blood pressure will be lower among the adult population who~     drink MAR water compared to people drinking saline or brackish groundwater Objectives: To~     determine~        1. If providing access to MAR water for drinking and food preparation reduces blood~          pressure among the adult population > 20 years of age.~        2. If providing access to MAR water for drinking and food preparation during pregnancy can~          reduce blood pressure among pregnant women.~        3. If MAR water is contaminated with E coli and fecal coliforms.~        4. Whether the MAR water is contaminated with dissolved constituents mobilized from~          aquifer sediments that are known to be harmful to human health.~      Methods:~      A stepped-wedge RCT will be conducted among communities before and after the intervention~     roll out. Study investigators will collect baseline information from all sites in the first~     monthly block (step) when no one will drink MAR water. There will be promoters who will~     convey messages regarding exclusive use of MAR water for drinking and cooking, at home and~     elsewhere. Measurements will be made by trained research assistants once every month. MAR~     water, pond water, groundwater and household stored water samples will be collected and~     tested once every month.~   "
23789|NCT02745990|"~     In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and~     function were associated with intermittent or sustained systemic inflammation (ISSI). Since~     EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic~     properties. Based on its potential for neuroprotection, the prospective randomized and~     masked study was designed to determine whether rhEPO （500u/kg) was also effective in~     improving developmental outcomes for extremely low gestational age newborns.~   "
23790|NCT02745977|"~     Breast feeding is the most nutritious form of nourishment in infants and is recommended for~     at least the first four months of life. Breast fed infants may develop milk protein~     intolerance. The management of breast milk protein intolerance differs from that of cow's~     milk protein intolerance in formula fed infants. Because breast milk is considered by many~     to be nutritionally superior to formula and results in maternal infant bonding mothers are~     often told to continue breast feeding. Despite the lack of evidence based data to support or~     refute the modification of the mother's diet, it is suggested that they eliminate their own~     intake of dairy products strictly and avoid supplementing with a cow's milk based formula.~     Investigators are doing this study to demonstrate that the deletion of dairy from the diet~     of a breast feeding mother will not cause breast milk protein intolerance to resolve.~   "
23791|NCT02745964|"~     The purpose of this study is to investigate and compare the incidence of the postoperative~     sore throat between LMA supreme and I-gel.~   "
23792|NCT02745951|"~     The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of~     administering Heliox in cardioplegia during cardiac surgery and whether it has the potential~     to reduce the incidence and severity of myocardial ischemia during and after cardiac~     surgery.~   "
23793|NCT02745938|"~     Mitochondrial disorders are a group of inherited disorders causing malfunctional~     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore~     give symptoms from every tissue, especially those with high energy needs as the brain, heart~     and muscles. The symptoms are often unspecific in terms of muscle weakness and fatigue,~     which delays the first contact to the doctor and further delays the diagnosis.~      The aim of this study is to investigate if it is possible to use GDF-15 (Growth and~     Differentiation Factor 15) as a biomarker for mitochondrial disease and compare the results~     with that of healthy controls, metabolic myopathies and muscular dystrophies. The~     concentration relative to exercise will further be investigated.~   "
23822|NCT02745561|"~     Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular~     endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and~     safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in~     esophageal cancer patients.~   "
23794|NCT02745925|"~     The main iron regulatory protein in the human metabolism is hepcidin. In normal weight,~     healthy subjects, hepcidin is regulated through the iron status of the body: low iron status~     results in low hepcidin concentrations, which facilitates dietary iron absorption. In~     obesity, which is an inflammatory state, hepcidin concentrations are increased and iron~     absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether~     lowering the chronic low-grade inflammation during a limited treatment period and thereby~     lowering hepcidin concentration can improve iron absorption is uncertain.~   "
23795|NCT02745912|"~     The purpose of this study is to determine the effect of multiple oral doses of~     naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.~   "
23796|NCT02745899|"~     the investigators hypothesis is that milk consumption, either in the acute phase and through~     prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation.~     the investigators aim to objectively prove this by examining respiratory symptoms and signs~     and objectively measuring parameters of airway inflammation and hyper responsiveness after~     consumption of cow milk or soy milk substitute.~   "
23797|NCT02745886|"~     The fact that metformin treatment has been associated with reduced risk of cancer and~     cardiovascular disease raises the possibility of a beneficial role of metformin for other~     age-related diseases. The actions of metformin resemble the effects of calorie restriction~     (CR) to some extent, and microarray analyses have shown that metformin induces a gene~     expression profile that aligns with that of CR in animal. The aim of the study is to~     investigate whether metformin treatment can induce dietary restriction-like state in human.~      Sixty overweight subjects will be included in this study, and participants will be divided 3~     groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet~     group, and CR group. All subjects will be treated 6 months. At the end of this study, blood~     samples and muscle samples will be obtained.~   "
23798|NCT02745873|"~     The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is~     a persistent and common environmental contaminant in most parts of the world. Vitamin C is a~     strong antioxidant and a metabolic co factor playing an important role in many biological~     processes and biochemical functions (hydroxylation reactions). The research objective is to~     assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4~     weeks on Blood Lead level among school going urban adolescents, using a cluster randomized~     trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two~     study arms.~   "
23799|NCT02745860|"~     Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the~     tablet developed for children.~   "
23800|NCT02745847|"~     The safety and efficacy of re-irradiation with stereotactic body radiotherapy for relapsed~     pancreatic cancer will be evaluated.~   "
23801|NCT02745834|"~     Case-control study to evaluate gait parameters during different conditions between patients~     who suffer from chronic ankle instability and healthy individuals.~   "
23802|NCT02745821|"~     Comprehensive assessment of coronary physiology (fractional flow reserve (FFR), coronary~     flow reserve (CFR) and index of microcirculatory resistance (IMR)) in patients with diabetes~     mellitus and coronary artery disease (CAD).~   "
23803|NCT02745808|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     feasible; 2) is treatment effective in improving the disease pathology of patients with~     diagnosed diabetic erectile dysfunction.~   "
23804|NCT02745795|"~     The objective of the study is to investigate the efficacy of motivational interview~     intervention with adolescent students at a school environment on the adhesion to a~     therapeutic plan to loose weight.~   "
23805|NCT02745782|"~     This study sought to comprehend the relationship between syncope and dental related therapy.~     If the relationship between dental related therapies and syncope is proved, clinical~     dentists will be remained to monitor changes of patient's blood pressure during root canal~     procedure.~   "
23806|NCT02745769|"~     The main purpose of this study is to evaluate the safety of ramucirumab in combination with~     other targeted agents in participants with advanced cancers.~   "
23807|NCT02745756|"~     This study adds an experimental treatment with another type of cells, called dendritic~     cells. It is hoped that these cells may stimulate the immune system to react against~     neuroblastoma in much the same way that vaccines cause the immune system to react to certain~     viruses and bacteria. The physicians conducting this study have observed from previous~     research that neuroblastoma cells can be recognized by the immune system, and that they can~     be destroyed by immune cells.The main goal of this study is to see if giving participants~     this additional anti-Neuroblastoma vaccine reduces the risk of relapse following the~     Hematopoietic Stem Cell Transplant.~   "
23808|NCT02745743|"~     The purpose of this study is to identify the most appropriate dose that can be safely~     administered and that can have an effect on blood cancer cells. Once that safe dose is~     identified, additional patients will be asked to join the study to further evaluate the~     safety and effectiveness of the study drug. The study will also investigate the~     pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics~     (study of what the drug does to the body), which may provide information about the effects~     of BAY 1251152. The study will also measure some biological markers (markers of biological~     activity in your body) that can be used to predict the response and safety of the proposed~     treatment.~   "
23809|NCT02745730|"~     Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure~     pleasantness after consumption of four different milkshakes with added sugars or sweeteners.~   "
23810|NCT02745717|"~     Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic~     reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy~     (IST).~      Study design: open-labed, prospective, multicenter, randomized control study Number of~     subjects: 60 each group~      Treatment:~      IST group: ATG (Thymoglobuline®, Genzyme) 3.5mg/kg/d×5d plus oral cyclosporine A (CSA) Cord~     blood transfusion group: In addition to the same dose and course of ATG and CSA , one unit~     of cord blood having no more than 2 HLA-A, B or DRB1 mismatches is transfused 24h after last~     dose of ATG administration.~   "
23811|NCT02745704|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha and NAs.~   "
23812|NCT02745691|"~     The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to~     change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients~     diagnosed with lung cancer. Participants will be enrolled in three groups according to their~     primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy). Various~     combinations of therapies are permissible, resulting in a total of eight subgroups (A.1~     Surgery alone and/or before any adjuvant therapy, A.2 Surgery [late effects], B.1~     Chemotherapy alone, B.2 Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent~     radiochemotherapy, C.1 Targeted therapy alone, C.2 Targeted therapy in combination with any~     other therapy).~      According to sample size calculations we will include a total of N = 400 patients. N = 120~     of these patients will be asked to fill in the questionnaires at a second time point, of~     which a subgroup of n = 60 will be subjected to test-retest analyses (patients who are~     clinically stable and indicate no change on an anchor question over the two assessment~     points), and another n = 60 will be subjected to test-retest analyses (those who indicate a~     change to the worse or to the better).~      Standard psychometric analyses will be employed to evaluate the hypothesized scale structure~     of the QLQ-LC29 and its internal consistency, convergent and discriminate validity, as well~     as test-retest reliability and responsiveness to change.~   "
23813|NCT02745678|"~     The purpose of this study is to investigate a novel thermosensitive topical gel formulation~     for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.~   "
23814|NCT02745665|"~     This is a pilot study with the purpose of measuring vascular function, assessed by~     evaluating arterial stiffness (pulse wave velocity and augmentation index) and endothelial~     function (flow mediated dilatation), in elite/amateur symptomatic male cyclists with~     unilateral Endofibrosis (EF), compared to asymptomatic males cyclists and to a group of age~     matched healthy males (non-athletes).~   "
23815|NCT02745652|"~     Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage~     to continue postnatal. Conservative treatment is more recommended in these cases. There are~     many physical therapy modalities proposed to treat CTS without knowing which modality is~     better than the other. So the aim of this study to compare the effect of two modalities in~     treating CTS in postnatal females.~   "
23816|NCT02745639|"~     This was a prospective phase II study on patients with locally advanced rectal cancer or~     local recurrence, to evaluate the pathological response and resectability of a neoadjuvant~     treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy~     ( XELOX).~   "
23817|NCT02745626|"~     Orthodontic treatment has been traditionally carried out with fixed appliances involving the~     use of stainless steel brackets and archwires. The challenge has been to move teeth and~     their roots effectively while minimizing iatrogenic damage such as root resorption and~     gingival inflammation. In recent years, with the development of new appliances and brackets~     such as self-ligating brackets and clear aligners there have been reports of improved~     periodontal status, less iatrogenic root damage and improved hygiene during treatment.~     Although these treatment modalities have been rapidly accepted in clinical practice, both~     clinical and basic science research data regarding their overall biological compatibility to~     support higher levels of evidence based dentistry (e.g, randomized clinical trials) is~     lacking. In other words, their advantages and disadvantages in this regard have not yet been~     scientifically evaluated. Such quantification will provide invaluable information for~     improvements in these treatment modalities.~      A randomized controlled clinical trial will be conducted with strict inclusion and exclusion~     criteria to test the following hypothesis (H) up to 18 months into treatment:~      H-1: There is no difference in the amount of root resorption caused by the three different~     appliances.~      H-2: Gingival health is not affected by the 'type of appliance' being used to correct the~     malocclusion.~      H-3: There is no difference in the amount of bacterial count and the type of appliance being~     used for orthodontic treatment.~      The hypothesis will be tested with the following specific aims (SA):~      SA-1: To investigate the amount of orthodontically induced inflammatory root resorption~     generated by treatment.~      SA-2: To evaluate the periodontal health of the patients with the different appliance~     systems.~      SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained~     in the plaque of orthodontic patients.~      SA-4: To ascertain whether there is an association between the microbial count and the type~     of appliance being used for orthodontic treatment~   "
23818|NCT02745613|"~     This study investigates weather a family history of type 2 diabetes affects exercise induced~     improvements in insulin sensitivity in the hispanic population~   "
23819|NCT02745600|"~     The main objective of the project is to bring the existing radio frequency ablation (RFA)~     model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February~     2012) into clinical practice. Therefore the project will pursue the following objectives:~      i) to prove and refine the RFA model in a small clinical study; ii) to develop the model~     into a real-time patient specific RFA planning and support system for Interventional~     Radiologists (IR) under special consideration of their clinical workflow needs; iii) to~     establish a corresponding training procedure for IR's; iv) to evaluate the clinical~     practicality and benefit of the model for use in the routine workflow in a user survey and~     expert forum.~   "
23820|NCT02745587|"~     At least 40% of the patients with prostate cancer (PC) present with positive lymph nodes~     (N1). The optimal treatment strategy for these patients remains controversial. Although~     androgen deprivation therapy (ADT) is still often initiated as only treatment, the results~     are disappointing. Recent studies support the use of more aggressive therapies including~     external beam radiotherapy (EBRT) and ADT. The retrospective studies supporting the~     additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent~     of radiation field.~      Even after an EPLND, there might be a role for pelvic EBRT in irradicating microscopic~     disease. However pelvic irradiation irrevocably results in increased toxicity. Moreover, in~     node negative (N0) PC patients the addition of pelvic EBRT has not resulted in improved~     outcome in randomised trials. However in the setting of Tumor Node Metastasis pathological~     stage (p)N1, proven on pathological examination, PC patients this has never been evaluated~     so far. This trial aims to answer the question whether or not pelvic EBRT is beneficial in~     pathological N1 PC patients. It is also important to realise that not all pathological N1 PC~     patients have similar outcome. There is a significant impact of number of positive lymph~     nodes on outcome, with two positive nodes being suggested as a significant cut-off value in~     predicting survival in pathological N1 PC patients. By stratifying the patients according to~     the number of lymph nodes involved this study will add to the proper selection of those~     patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no~     benefit of pelvic EBRT.~      Additionally, small RNAs constitute potentially valuable markers for the diagnosis,~     prognosis, and therapeutic choices in PC patients. Blood samples will be collected to~     examine the potential role of miRNAs as a biomarker and to develop a prognostic signature~     for clinical relapse-free survival.~      The results of this trial will serve as a base for developping new trials in order to~     optimise the treatment of patients with pathological N1 PC.~   "
23821|NCT02745574|"~     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter~     hospitalizations, and less post-operative pain as compared with traditional laparotomies.~     However, there is marked interindividual variability of post-operative shoulder-tip pain~     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and~     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours~     after surgery.~      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic~     nerve irritation causes referred pain to C4. Therefore, we should try to do is that if we~     could reduce carbon dioxide retention in the pelvic cavity.~      This clinical controlled trial is tried to find out the practical and clinical maneuver to~     reduce post-operative should-tip pain following laparoscopic surgery.~   "
23823|NCT02745548|"~     In order to better understand radiation-induced lung toxicity, the investigator proposes a~     novel functional avoidance approach that incorporates central as well as peripheral BSS~     segments in the treatment planning process in order to quantify and account for their~     respective radiosensitivities. Specifically, the investigator proposes a systematic study~     that involves acquiring pre- and post-SAbR high-resolution CT and SPECT V/Q scans from lung~     cancer patients who receive radiotherapy, followed by auto-segmentation of the BSS elements~     using virtual bronchoscopy.~   "
23824|NCT02745535|"~     This study will evaluate the safety, tolerability, and efficacy of~     sofosbuvir/velpatasvir/GS-9857 (SOF/VEL/GS-9857) in adults with chronic hepatitis C~     infection who have failed to eradicate hepatitis C despite previous combination directly~     acting antiviral therapy.~   "
23825|NCT02745522|"~     The current study aimed to investigate whether oxytocin (OXT) had effect on placebo~     analgesia.~   "
23826|NCT02745509|"~     The investigators study aims to explore the potential function of extensive intraoperative~     peritoneal lavage in improving the overall survival and progression-free survival for~     locally advanced gastric cancer after curative resection.~      Hypothesis: Overall survival and progression-free survival of locally advanced gastric~     cancer are improved by extensive intraoperative peritoneal lavage.~   "
23827|NCT02745496|"~     The clinical trial aims to address the critical challenge of differentiating aggressive from~     indolent prostate cancers by correlating prospectively collected MultiParametric (MP)~     Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical~     prostatectomy specimens (reference standard).~      The study design incorporates pre-biopsy MRI, routine standard of care Transrectal~     Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide~     biopsies to the suspicious areas identified by MRI.~      The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer~     aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci~     within the prostate gland for guiding biopsies.~      Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better~     inform clinicians and patients to improve risk stratification and facilitate decision making~     on subsequent treatment.~      Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for~     biopsy, which could obviate the need for multiple biopsies.~   "
23828|NCT02745483|"~     The purpose of this study is to compare the therapeutic outcomes and safety of the study~     patients who received radiofrequency ablation (RFA) using separable clustered electrodes~     with those of a matched historical control group who had received RFA using multiple~     internally-cooled electrodes.~   "
23829|NCT02745249|"~     Inadequate maternal nutrition is likely to undermine the potential impact of infant and~     young child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because~     it is linked to poor fetal growth leading to small-for-gestational age and pre-term~     newborns. These babies do not respond to growth promoting feeding practices as well as~     normal newborns do. In Phase 2, Alive & Thrive decided to focus on integrating a package of~     maternal nutrition interventions in a large-scale maternal, newborn and child health program~     (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal~     nutrition interventions into an existing MNCH platform in Bangladesh, using a~     cluster-randomized evaluation design.~   "
23830|NCT02745236|"~     Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an~     irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant~     symptoms as well as increases the person's risk of stroke and heart failure. With an ageing~     population, increasing rates of AF and limited access to specialists, new methods of care,~     like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide~     sustainable care.~      The objective of the project is to evaluate the effect of Nurse Practitioner-led care in~     people with AF on their quality of life.~      The Canadian Healthcare system is overwhelmed, with increasing costs and wait times.~     Contributing to these issues, is AF is the most common arrhythmia accompanied with costly~     complications including stroke and heart failure. Currently family or emergency room~     physicians ask general cardiologists or specialized cardiologists, to provide care to~     patients with AF. Unfortunately, there is limited access to their services. NP's are nurses~     who have taken extra education at University to treat patients and prescribe medications.~     This research project involves an NP who has specialized training in AF patient management.~      By utilizing an NP to provide care for patients with AF, the investigators hope to improve~     patient's quality of life and satisfaction with care. This may also reduce complications of~     AF.~   "
23831|NCT02745223|"~     A study to establish safety, tolerability, and efficacy of PresbiDrops in presbyopic~     subjects.~   "
23832|NCT02745210|"~     Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI~     morbidity remains a public health challenge and is the leading cause of disability in the~     United States To combat these effects, new research is needed to identify mechanisms of~     injury that will lead to potential targets for therapeutic interventions that improve~     neurological outcome. One promising area of research is the cerebral metabolic dysfunction~     following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral~     metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after~     injury with the duration and degree of hypometabolism correlating to level of consciousness~     and a strong predictor of long-term neurological outcome. However, specific changes in~     intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the~     role of astrocyte metabolism in the post-injury metabolism has not been studied. This study~     uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the~     clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose~     (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through~     metabolic pathways during the hypometabolic period. In addition, the investigators will~     study the association of decreased cerebral perfusion with changes in glucose and acetate~     metabolism following TBI, as changes in cerebral perfusion could profoundly affect cerebral~     metabolism by limiting substrate availability.~   "
23833|NCT02745197|"~     This study evaluates a nutritional supplement in the treatment of pancreatic cancer in~     adults. Half of the participants will receive the nutritional supplement, while the other~     half will receive a placebo.~   "
23834|NCT02745184|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized~     by a progressive damage of lung structure and decline in lung function.This study intends to~     carry out an open, single-center, non-randomized, self control phase I clinical trial.~     During the treatment, lung stem cells will be isolated from patients' own bronchi and~     expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic~     bronchoscopy after lavage. After twelve-month observation, the investigators will evaluate~     the safety and efficacy of the treatment by measuring the key clinical indicators.~   "
23835|NCT02745171|"~     Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system~     of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased~     concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting~     tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy,~     physical therapy is also considered a useful tool for the treatment of motor disorders of~     the disease. The role of physiotherapy aims to stimulate the security and independence of~     patients with PD in carrying out activities and to preserve and improve physical function.~     Some studies have shown the negative effect of the disease on quality of life and functional~     mobility. Few studies have been conducted to evaluate the effects of long-term therapy in~     PD, but many report the beneficial effects of a rehabilitation program in a short period of~     time.~      Objective: To continually assess the effects after the completion of a physical therapy~     program in patients with Parkinson's disease.~      Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital~     of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in~     stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental.~     Patients who are recruited will undergo an assessment using the scales of assessment of~     functional mobility, quality of life and motor examination before starting physical therapy~     at the end of treatment and two months after completion of treatment, and the intervals~     assessments of a month.~   "
23836|NCT02745158|"~     The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is a global,~     non-interventional, voluntary database that captures demographic and disease data directly~     from FOP patients and their caregivers via a secure, web-based patient portal. A physician~     portal (in development) will allow physicians to enter clinical data about their patients.~     The objectives are to organize the international FOP community for participation in clinical~     trials; to enable FOP patients worldwide to report data in a shared forum; to improve the~     collective understanding of FOP natural history; and to advance the understanding of FOP~     treatment outcomes.~   "
23837|NCT02745145|"~     The purpose of this trial is to compare two doses of abituzumab with placebo and determine~     whether abituzumab is more effective, safer, will be better tolerated and can provoke better~     immune response than placebo in the treatment of patients with SSc-ILD who already receive~     constant doses of mycophenolate.~   "
23838|NCT02745132|"~     The overall aim of this study is to evaluate the prevalence of cognitive impairments and~     brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely~     changes in cognition and brain structure and function after treatment with Direct-acting~     Antivirals (DAAs).~   "
23839|NCT02745119|"~     This multicenter open-label extension study is designed to evaluate the safety and~     tolerability of lampalizumab intravitreal injections in participants with GA secondary to~     age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies~     GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from~     the parent studies who received investigational lampalizumab, as well as lampalizumab-naive~     participants exposed to sham comparator. All participants will receive open-label~     lampalizumab in the present study.~   "
23840|NCT02745106|"~     The study evaluates the technique of non-drug treatment of residual pulmonary hypertension~     in patients with chronic thromboembolic pulmonary hypertension after pulmonary~     thromboendarterectomy.~   "
23841|NCT02745093|"~     The purpose of this study is to assess the effectiveness, safety, and acceptability of~     home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12~     weeks among a cohort of women in Mexico City.~   "
23842|NCT02745080|"~     The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy~     and adalimumab monotherapy in patients with active psoriatic arthritis who are naïve to~     biologic therapy and are intolerant or having inadequate response to conventional DMARDs~   "
23843|NCT02745067|"~     The primary objective of this study is to gain knowledge about the effectiveness of enhanced~     cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).~   "
23844|NCT02745054|"~     The goal of SOAR is to characterize the clinical and economic impact of clinicians'~     responses to major bleeding complications and pre-procedural concerns for bleeding risk in~     patients treated with oral anticoagulants (warfarin, anti-Xa orals, and anti-thrombin (IIa)~     orals) who present to the ED or in the hospital with acute illness or injury, with the~     eventual aim of informing the development of improved approaches to the management of OACs~     in the ED.~   "
23845|NCT02745041|"~     -  Haemorrhage in severe trauma is a significant cause of mortality and is potentially the~          most preventable cause of death in trauma patients~        -  Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe~          trauma~        -  Hypo/dysfibrinogenaemia plays an important role in TIC~        -  Early replacement of fibrinogen may improve outcomes~        -  Fibrinogen replacement is potentially inadequate in standard fixed ratio Major~          Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate~        -  The majority of centres utilise cryoprecipitate for additional fibrinogen~          supplementation as part of a MHP~        -  Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed~          ratio MHP~        -  It is clear early intervention in severe traumatic haemorrhage is associated with~          improved outcomes - CRASH 2 and PROPPR studies~        -  Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but~          not supported by high level evidence~        -  Benefits of FC - viral inactivation, known dose, easily reconstituted, can be~          administered quickly in high dose and stored at room temperature in the trauma~          resuscitation bay~        -  No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients~        -  Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment~          algorithm~        -  It will be a pilot, multi-centre randomised controlled trial comparing FC to~          Cryoprecipitate (current standard practise in fibrinogen supplementation)~        -  Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved~          quicker with a more predictable dose response using Fibrinogen Concentrate compared to~          Cryoprecipitate~        -  It is imperative that robust and clinically relevant trials are performed to~          investigate fibrinogen supplementation in trauma before widespread adoption makes~          performing such studies unfeasible~   "
23846|NCT02745028|"~     Children with a radionuclide gastric emptying test with abnormal results will undergo a~     second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose~     of the study is to determine if a single dose of monosodium glutamate can shorten the~     gastric emptying time.~   "
23847|NCT02745015|"~     The aim of this study is to investigate the effects of non-surgical periodontal treatment on~     the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus~     patients and confirmed chronic periodontitis will be selected and randomly assign to two~     groups. The treatment group will receive immediate full-mouth scaling and root planing~     whereas the control group will be scheduled to receive periodontal treatment at the~     following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and~     cervical attachment loss will be recorded at baseline, at six weeks and at three months.~     Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and~     three months following enrolment.~   "
23848|NCT02745002|"~     Electromagnetic navigation systems have proved feasible for precise intraoperative guiding~     during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration~     (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can~     point out malignant lesions.~      When fused into a research navigation system, functional imaging can add information of~     optimal sampling points in lung cancer staging. Correct image registration is then~     fundamental. This study is a build--on to NCT02493023, assessing the position and image~     registration accuracy and clinical feasibility of a multimodal image guiding system in~     patients referred for lung cancer staging by EBUS--TBNA.~   "
23849|NCT02744989|"~     This project aims to provide the proof of concept for transcranial direct-current~     stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The~     purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients~     demonstrating a partial response to a first frequently prescribed antipsychotic medication.~     An early optimization of the therapeutic strategy must constitute an important factor for~     prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the~     clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic~     medication, and will be used in a broad variety of patients, i.e. in patients with varied~     durations of illness, various symptoms profiles, and various levels of treatment response.~     This in turn will allow the determination of the extent to which results can be generalized~     to varied patient populations, as well as the extent to which various therapeutic targets~     (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be~     improved with tDCS. Despite interesting preliminary results, our team is unable to describe~     optimal non-invasive brain stimulation (NIBS) response markers.~      This study is a randomized, double blind, controlled, French multicenter study (11 centers).~     The investigators plan to include 138 patients with persistent symptoms in schizophrenia.~     Sixty-nine subjects will receive active tDCS and 69 subjects will receive sham tDCS~     (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as~     measured by the number of responders, defined as a decrease of at least 25% of symptoms as~     measured by a standardized clinical scale score (PANSS) between baseline and after the~     10-session tDCS regimen.~      Furthermore, the participants believe that an in depth understanding of the cortical effects~     of tDCS could constitute an important step towards improving the technique and developing~     treatment response markers. An analysis of the effects on cortical activity and plasticity~     markers could be an interesting approach.~   "
23850|NCT02744976|"~     Prediabetes is a disorder of glucose metabolism that reflects the natural history of~     progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have~     impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing~     percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and~     coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent~     restenosis after bare metal and drug-eluting stent implantation more frequently is observed~     in patients with high fasting-insulin levels and IR. Although IR has a significant role in~     the progression of atherosclerosis in prediabetic patients, the importance of managing~     prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment~     has been officially approved for prediabetes. According to American Diabetes Association~     recommendations, metformin is the only drug that could be considered in the treatment of~     prediabetic patients with a high risk of developing diabetes. Metformin is a safe and~     inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events~     in patients with type 2 diabetes as well as the progression of atherosclerosis in~     non-diabetic animal models. This study was designed to analyze coronary plaque~     characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to~     evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic~     patients at 24 month follow up.~      The study hypothesis is that more pronounced coronary atherosclerosis progression as well as~     in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin~     treatment attenuates the progression of atherosclerosis in patients with prediabetes.~   "
23851|NCT02744963|"~     This trial evaluates the effect of providing primary care patients with free and convenient~     access to a set of essential medicines. Half of the participants will receive free and~     convenient access to these essential medicines, while the other half will have usual access~     to medicines.~   "
23852|NCT02744950|"~     Surgical defects on the scalp require closure via various techniques of suture placement. A~     traditional technique requires both dermal (deep) and epidermal (superficial) placement of~     sutures to close the defect; this is referred to as intermediate or complex linear repair.~     However, the scalp is a location with high tension, and thus the closures take an hour or~     longer to perform. A type of suture placement referred to as the pulley stitch requires~     placement of a few stitches along the defect. The pulley stitch can be used in areas of high~     tension to close a large defect. The purpose of this study is to compare the scar results~     and time taken to perform scalp closures via only pulley stitches or via~     intermediate/complex linear repairs.~      To my knowledge, no such study has been performed to compare the two techniques. Such a~     study would be useful in demonstrating comparable scar appearance and reduce the time to~     perform scalp closures.~   "
23853|NCT02744937|"~     Objectives: To determine whether TRUS-guided prostate biopsy performed in patients~     continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and~     severity of bleeding complications.~      Eligibility: Men over 40-year-old with an elevated serum prostate-speciﬁc antigen level~     and/or abnormal digital rectal examination ﬁndings are candidates for PB.~      Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin~     before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity~     of bleeding complications Statistical analysis and sample size estimation: Fisher's exact~     test or chi-square test will be used to explore the differences between two groups for~     categorical variables, and Student t-test will be used for continuous variables. Under the~     assumption of a difference of 25% of bleeding complications in each group, with α=0.05 and~     power=0.80, 60 subject are needed in each arm. Assuming the drop-out rate to be 20%, the~     targeted recruit number is 150 in total.~   "
23854|NCT02744924|"~     To develop and implement a physical activity promotion intervention for older adults with or~     without chronic disease living in an urban environment.~   "
23855|NCT02744911|"~     Telehealth, increasingly recognized in the neurology field as a solution to access issues~     for people with Parkinson's disease, improves access to speech therapy, particularly those~     living in rural areas or with travel barriers. The SpeechVive device, developed by~     SpeechVive, Inc., is a treatment solution that is easy to use and effective. In an NIH~     funded study, the SpeechVive device improved communication in 90% of individuals with PD by~     improving volume, articulation, and speech rate. The investigators propose to eliminate the~     one drawback of the SpeechVive device, namely that it currently must be programmed by a~     speech-language pathologist for each patient in person. The overall goal of this project is~     to develop a telehealth platform for the SpeechVive device that will enable video~     conferencing for treatment and remote programming of the SpeechVive device for each patient.~     Once the platform has been developed, the investigators will conduct a study to examine~     effectiveness and the patient and caregiver satisfaction with telepractice using the~     SpeechVive device.~   "
23856|NCT02744898|"~     The purpose of this study is to evaluate the safety of treatment with carboplatin and~     Abraxane in this patient population and determine the nature and degree of toxicities~     following treatment. The single stage open label Phase II feasibility study is designed to~     estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with~     no more than two dose level reductions.~   "
23857|NCT02744885|"~     The purpose of the research is to determine if participants who take Crave Crush will~     report lower cravings and palatability ratings of candy as compared to subjects who receive~     the placebo. Participants are self-selected university students who pass our table and~     verbally agree to participate in a research study about taste preferences. Data will be~     recorded anonymously.~   "
23858|NCT02744872|"~     Lung transplanted patients experience marked decrease in renal function post transplant~     mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal~     function in cyclosporine treated transplant recipients through their effects in avoiding~     cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.~      The aim of this study is to examine if calcium channel blockade administered before lung~     transplantation prevent cyclosporine induced nephropathy.~      The design is an intention to treat randomized double blinded single center study. Patients~     are randomized to two groups, one that received felodipine and one that receives placebo.~      Study population is all patients listed for lung transplantation in Denmark in the study~     period.~      Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks~      Primary endpoint is change in renal function as measured by glomerular filtration rate using~     chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated~     group compared with the placebo group.~   "
23859|NCT02744859|"~     Investigators will run a field study evaluating the impact different labels have on the~     purchasing of sugar sweetened beverages. This field study will take place in a hospital~     cafeteria.~   "
23860|NCT02744846|"~     The objectives of the proposed study are to assess the effects of different types, timing,~     and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass~     index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to~     age 5 years. In Specific Aim 3, the investigators will address how big the effects of~     antibiotics on obesity are within subgroups of the population, such as different~     racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.~      The data for this study will come from electronic medical records of about 600,000 children~     from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the~     United States. The investigators will get information on antibiotic prescribing in the first~     two years of life, then virtually follow these children to ages 5 and 10 years to see what~     their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index~     exceeding the 95th percentile for age and sex).~      In the main analyses, the CDRNs will not send any individual data to a central site. Rather,~     using sophisticated computer programs, the study's coordinating center will send questions~     to the data, thus protecting the privacy of patients' and the healthcare systems' records.~     In some analyses, to check how well this distributed research network approach works, we~     will work with individual records whose identifying information has been stripped off~     (de-identified data).~      In our Secondary Aim, the investigators will employ focus groups of parents and in-depth~     interviews with clinicians to explore how best to put the findings into everyday practice.~      Throughout the study, in addition to employing privacy-protecting approaches to analyzing~     and sharing data, the investigators will adhere to principles of inclusion,~     patient-centeredness, stakeholder engagement, effective governance, and protection of human~     subjects. At the end of the two-year project, the investigators will propose avenues for~     dissemination of the scientific findings and other products.~   "
23861|NCT02744833|"~     This study will evaluate the safety profile of GMI-1271 and its effect on thrombus~     resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).~   "
23862|NCT02744820|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2~     diabetics.~      The secondary objective is to explore the effect of multiple oral doses of GMC-252 on~     pharmacodynamic(PD) parameters in type 2 diabetics.~   "
23863|NCT02744807|"~     This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe~     intrauterine adhesions and compare recurrence of adhesion in women with and without CE.~   "
23864|NCT02744781|"~     This study examined whether there is an association between the presence of lumbar~     intervertebral disc degeneration (LDD) and the size and symmetry of the cross-sectional~     areas (CSAs) of the trunk muscles in combat sports athletes. Participants in this study were~     collegiate combat sports athletes. All intervertebral discs from L1/2 to L5/S1 in all~     athletes were assessed using MRI and a comprehensive grading system of LDD (grades I-V). All~     151 athletes were divided into 2 groups: LDD and non-LDD. CSAs of trunk muscles at the L3/4~     disc level were measured on MRI.~   "
23865|NCT02744768|"~     This study aims at exploring the activity of a frontline approach based on dasatinib plus~     steroids administration as induction treatment, followed by the infusion of Blinatumomab, in~     adult Ph+ ALL.~   "
23866|NCT02744755|"~     Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid~     Arthritis~   "
23867|NCT02744742|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess~     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome~     (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS~     undergoing allo-HSCT remains in discussion. In this study, the safety and efficacy of~     Decitabine + BUCY and BUCY myeloablative conditioning regimens in patients with RAEB-1,~     REAB-2 and AML Secondary to MDS undergoing allo-HSCT are evaluated.~   "
23868|NCT02744729|"~     This is an open-label single photon emission computed tomography / computed tomography~     (SPECT/CT) study to investigate the safety and diagnostic performance of~     99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of~     nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously~     injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative~     method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any~     adverse events will be collected from the patients.~   "
23869|NCT02744716|"~     This study aimed To investigate the effects of estrogen in combination with aspirin and~     intrauterine balloon on the uterine endometrial repair and reproductive prognosis in~     patients after surgery for severe intrauterine adhesion .~   "
23870|NCT02744703|"~     Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin~     cause degradation of the collagen proteins and loss of bond strength in adhesive~     restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal~     MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be~     beneficial for the bonding of resin material and tooth substrate over the course of time.~     This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength~     of a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on~     10 patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal~     surfaces of one of the two premolar teeth in each patient were randomly assigned into four~     treatment groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch~     adhesive (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive~     (control) (S) followed by restoration and 3 months of intra-oral functioning. After teeth~     extraction, the specimens were stored in distilled water+thymol solution at 4°C to inhibit~     microbial growth and used in one week period. Dentin-composite sticks were obtained from~     each restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure~     mode analysis was performed microscopically. Data were analysed statistically using Repeated~     Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds~     significantly increased the composite resin restorations' bond strengths to dentin applied~     with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor~     prior to the the resin restorations. However further long term clinical studies are needed~     to support the use of CAPE pretreatment along with self-etch and total-etch adhesive~     systems.~   "
23871|NCT02744690|"~     This study is a randomized, double-masked trial to examine the response to trabeculectomy~     surgery. In this study, patients will be randomized to receive MMC via subconjunctival~     injection or topical sponge application.~   "
23872|NCT02744677|"~     The purpose of this study is to evaluate the hypothesis that valve dysfunction of the~     Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the~     performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract~     (RVOT) conduit with a clinical indication for intervention.~   "
23873|NCT02744664|"~     This trial is to designed to assess the efficacy and safety of Cryotherapy combine with~     Icotinib for Advanced NSCLC Patients harboring EGFR mutation.~   "
23874|NCT02744651|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this~     study is as follows:~      - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle~     aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal~     tumors in the upper GI tract.~   "
23875|NCT02744638|"~     The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt~     containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L.~     rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3~     weeks following a standard antibiotic treatment with metronidazole.~   "
23876|NCT02744625|"~     The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with~     and without sedation) and in vasopressor-dependent patients~   "
23877|NCT02744612|"~     This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating~     patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment~     (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as brentuximab vedotin, may interfere~     with the ability of cancer cells to grow and spread. Giving ibrutinib together with~     brentuximab vedotin may be a better treatment for Hodgkin lymphoma.~   "
23878|NCT02744599|"~     This is a small trial to test feasibility of an idea for a potential device. The~     investigators tested the feasibility of prompting a volunteer to breathe when their~     breathing had slowed down during administration of anesthetic drugs.~   "
23879|NCT02744586|"~     The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention~     will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good~     Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing~     (CVCT), among concordant HIV-negative couples living in Zambia.~   "
23880|NCT02744573|"~     There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The~     analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.~   "
23881|NCT02744560|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents~     the most available noninvasive technique to assess the level of iron in the liver.there is~     evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and~     liver failure in those with chronic liver disease.~   "
23882|NCT02744547|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels~     correlate with histological stages of liver fibrosis in hepatitis C patients, so it has a~     good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is~     evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and~     liver failure in those with chronic liver disease.~   "
23883|NCT02744534|"~     The purpose of this study is to see if using Positron Emission Tomography (PET) scan and~     transrectal ultrasound (TRUS) guided biopsy together (creating a 3-dimensional ultrasound)~     will detect prostate cancer more accurately than the standard 2-dimensional approach which~     uses only the TRUS to guide the biopsy.~   "
24268|NCT02739516|"~     The objective of this study was to evaluate the outcome of follicle stimulating hormone~     (FSH) co-administration with human chorionic gonadotrophins trigger for women with~     unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine~     insemination (IUI) cycles .~   "
23884|NCT02744521|"~     Introduction: Finding and successfully treating all tuberculosis (TB) patients is the~     cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited~     countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there~     is a need to find feasible interventions to find and treat TB patients in these settings.~      Objective: The objective of this study is to evaluate whether empowering and involving~     inmate peer educators in TB control has an impact on increasing TB case detection rate and~     improving treatment success in resource-limited prison settings.~      Methodology: This is a matched cluster randomized control trial where randomization to the~     intervention and treatment groups will be carried out within pairs. Eight matched prison~     pairs will be randomly selected for this study in which eight prisons from each pair will be~     randomly assigned to the intervention and the remaining to the control group. Trained prison~     peer educators at the intervention sites will organize and provide education about TB every~     two weeks on a regular basis for one year. Peer educators will also perform routine TB~     screening, using a screening protocol to identify presumptive TB cases for a referral.~     Identified presumptive TB cases will then be linked to the prison health personnel for a~     referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites~     using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis~     case finding in the control sites will follow the existing referral system (self-referral to~     nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or~     chest X-ray as in the intervention sites. The data will be entered using Epi Data entry~     version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of~     analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the~     percentage of patients symptomatic for > =3 months will be compared within pairs using the~     paired t-test or sign test as appropriate.~   "
23885|NCT02744508|"~     Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk~     factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is~     related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is~     the most recent medication for prevention of PONV. Purpose of our study is comparison of~     PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.~   "
23886|NCT02744495|"~     To investigate the role of postoperative nausea and vomiting risk factors assessment after~     cardiac surgery. We designed a randomized controlled study comparing standard care (no risk~     factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting~     after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and~     vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac~     surgery, depending on risk factors (if risk score is over 2) in the intervention arm.~   "
23887|NCT02744482|"~     This is an experimental study, prospective, comparative. This clinical trial is randomized~     and double-blind, Residronate versus placebo.~      The study aims to demonstrate the effectiveness of risedronate in pain management, after 18~     month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were~     compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the~     second a placebo.~      Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive~     days each month.~      Evaluations are planned evry 6 months.~   "
23888|NCT02744469|"~     Tuberculosis is a public health problem caused by a microbe. This microbe may differ from~     one patient to another. The purpose of this study is to know to which extent, each of these~     various microbes is involved in tuberculosis disease in Benin. This study will also find out~     whether the type that affects a patient, depends on patient characteristics and whether the~     difference affects the outcome of the treatment. Finally the study will also help to find~     out whether diagnostic tests are reliable for all types of the microbe. This information~     will be used after the study to inform decision making in order to improve tuberculosis~     control.~   "
23889|NCT02744456|"~     Many patients want to know which blood pressure medication is the best for them. In this~     study, we will test the feasibility of a new approach to determining the best blood pressure~     medication for individual patients by performing an N-of-1 trial in which patients will have~     the opportunity to test a series of 3 blood pressure medications at escalating doses while~     carefully measuring their blood pressure and side-effects. At the end of each of these~     N-of-1 trials, we will ask patients to complete a questionnaire in which they rate their~     level of satisfaction with this approach to learning about which is the best blood pressure~     medication for them.~   "
23890|NCT02744443|"~     Leucine supplementation could be useful to support muscle anabolism. This study aims to~     investigate the effects of leucine supplementation on muscle mass and muscle strength in~     young subjects undergoing resistance training.~   "
23891|NCT02744430|"~     The study will be a prospective randomized double-blind placebo-controlled trial of~     mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography)~     scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.~   "
23892|NCT02744417|"~     The aim of this prospective interventional study is to verify the efficacy of smoking~     cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of~     chronic periodontitis patients. Smokers willing to quit received periodontal treatment and~     concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months.~     A single calibrated examiner, blinded to smoking status, assessed periodontal clinical~     outcomes and applied a structured questionnaire in order to collect demographic and~     behavioural information. Further, expired carbon monoxide concentration were measured with a~     monoximeter. A pooled subgingival plaque sample was collected from the deepest periodontal~     pocket from each participant. The presence and quantification of Aggregatibacter~     actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema~     denticola were determined using (RT-PCR).~   "
23893|NCT02744404|"~     In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of~     age) is conducted using molecular diagnostics at central laboratories. However, test volumes~     are growing and many parts of the country do not have close or easy access to laboratories.~     Test samples are transported over large distances and this can introduce testing delays,~     especially for patients in rural and remote areas of the country. There are growing numbers~     of high quality Point-Of-Care (POC) diagnostic technologies available and there is~     increasing interest in using these technologies to alleviate critical testing needs. This~     protocol describes an observational study looking at the patient impact of implementing POC~     EID technologies within the routine standard of care at seven facilities.~   "
23903|NCT02744274|"~     The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of~     chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized,~     assessor- and participant-blinded, controlled, and parallel-design approach to investigate~     whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and~     improve quality of life.~   "
23894|NCT02744391|"~     This study will elucidate the neurobiology of slowing and LLD, identify a novel therapeutic~     target for depression, and contribute to the development of personalized treatment regimens~     for LLD. The multimodal neuroimaging methods detailed in this application will provide~     information about the neurobiology of aging-associated slowing and LLD at molecular,~     structural, and functional levels of analysis. These data will fill a crucial gap in our~     knowledge regarding what are the physiologic and functional consequences of dopamine~     depletion occurring across the lifespan in individuals without PD. Results from this project~     also will allow us to evaluate a novel therapeutic approach to LLD, which could have large~     public health ramifications given the prevalence, frequent treatment resistance, and~     chronicity characteristic of LLD. Even apart from patients with LLD, cognitive and motor~     slowing exact a large public health burden in terms of impaired functioning and increased~     morbidity and mortality, and this burden will only grow as the population ages. It is~     critical to develop treatments capable of altering the negative health trajectories~     associated with slowing in order to help older adults maintain independent functioning and~     live longer with an increased quality of life. Finally, while PET and MRI may prove critical~     to understand the neurobiology of slowing and LLD, their invasiveness and expense limit~     their roles in informing treatment decisions in clinical practice settings. For this reason~     the investigators are also assessing the influence of genetic moderators such as~     interleukin-6 (IL-6) and catechol-O-methyl-transferase (COMT) genotype on baseline dopamine~     functioning and response to L-DOPA. This may facilitate the identification of both high-risk~     individuals and those most likely to benefit from treatment interventions.~   "
23895|NCT02744378|"~     This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in~     symptomatic Oral Lichen Planus.~   "
23896|NCT02744365|"~     The Biobank includes data and biological specimens of women from three original studies: 1)~     First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia~     And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3)~     Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and~     4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following~     Combined Iterative Screening.~   "
23897|NCT02744352|"~     The purpose of this study is to compare infraclavicular brachial plexus shot single shot~     block to continuous catheter nerve block done in adult patients who have under gone surgery~     to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of~     recovery and quality of sleep up to 72 hours post operatively will be used for comparison.~   "
23898|NCT02744339|"~     The primary objective of this study is to~      • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary~     hypertension and heart failure with preserved ejection fraction~      The secondary objectives of this study are to~        -  Assess safety and tolerability of riociguat in this study population~        -  Assess changes in dimensions of left and right ventricles and cardiac function~          parameters using cardiac magnetic resonance imaging~   "
23899|NCT02744326|"~     The investigators will conduct a prospective study and a randomized controlled trial (RCT)~     involving children and adolescents presenting with a primary mental health (MH) concern to~     the emergency departments (EDs) of Children's Hospitals and Clinics of Minnesota (CH). The~     investigators will characterize the primary MH concerns of 800 patients and assess their~     baseline access to and utilization of external resources. All enrolled patients will be~     followed 3-months after their initial visit to determine ED revisits and identify factors~     associated with connection to outpatient care. The RCT portion of the study will involve 200~     patients discharged from the ED with a referral to an outpatient MH provider, and will test~     a novel text-message communication method by which parents/caregivers can be encouraged to~     complete follow-up care for their child. The experimental group will receive tailored text~     message reminders regarding follow-up appointments.~      Relevance: Pediatric ED visits for MH issues are increasing, but the current system of~     managing these patients is not optimal. More information is needed to accelerate change and~     to efficiently invest in improving services available to MH patients. Specifically,~     information is needed on which MH populations need to be targeted, and on simple,~     reproducible interventions which improve connection with community resources. The proposed~     study will collect vital information needed to develop programs that improve outcomes and~     reduce ED revisits in pediatric patients visiting the EDs at CH with primary MH concerns,~     and will set the stage for future work focused on improving core and outcomes for MH youth.~   "
23900|NCT02744313|"~     This study will focus on a population of antipsychotic (AP) naïve adolescents and young~     adults and will measure fat accumulation in relation to exposure to atypical antipsychotic~     medications.~   "
23901|NCT02744300|"~     Women with a history of gestational diabetes mellitus (GDM) have an increased risk of~     developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a~     web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention~     Program (DPP), modified specifically for women with a recent history of GDM. This program,~     delivered in the first year postpartum, encouraged weight loss, dietary changes, and~     physical activity. The purpose of the current study, called Balance After Baby Intervention~     2 (BABI-2), is to study a larger group of women with two years of follow-up. We will assess~     whether women assigned to the intervention group lose more weight and decrease their risk~     factors for type 2 diabetes.~      Participants assigned to the BAB lifestyle intervention will receive support from a~     lifestyle coach and gain access to a website with online presentations that contain healthy~     eating and physical activity educational tips.~      Participants assigned to the post-GDM follow-up group will have access to a website~     containing links to information about diabetes prevention.~   "
23902|NCT02744287|"~     In this protocol, patients with non-resectable pancreatic cancer will have autologous T~     cells collected via apheresis and genetically modified using a retrovirus to express the~     anti-PSCA Chimeric Antigen Receptor (CAR). The T cells will be reinfused according to a~     dose-finding schedule after the subject has been identified as having adequate lymphopenia~     to provide for homeostatic expansion of the adoptively transferred, engineered T cell~     therapeutic product.~   "
24269|NCT02739503|"~     This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head~     Circumference (FHC) could potentially possess a predictive role in determining women at~     increased risk for operative delivery or cesarean section.~   "
23904|NCT02744261|"~     The purpose of this study is to (a) adapt existing user sensory perception and experience~     (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs~     specific to suppository forms for rectal and vaginal use; (b) for both male and female~     cohorts: to capture the experience of suppository use in the context of receptive anal~     intercourse (RAI); and (c) for female cohort only: to capture the experience of suppository~     use in the context of vaginal-penile intercourse (VI), and to compare USPEs of suppository~     use in the context of RAI to USPEs of suppository use in the context of vaginal-penile~     intercourse.~   "
23905|NCT02744248|"~     Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP~     magnetic resonance imaging (MRI) contrast agent in healthy subjects.~      Secondary:~        1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy~          subjects.~        2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.~        3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy~          subjects.~   "
23906|NCT02744235|"~     The purpose of this study is to compare two popular portable sleep monitoring devices—the~     Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app—to the gold standard~     Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep~     efficiency, and sleep staging. Specifically, this study will investigate the validity of the~     Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in~     comparison to conventional Polysomnography (PSG).~   "
23907|NCT02744222|"~     International multi-center double-blind comparative randomized clinical trial to evaluate~     efficacy, safety and tolerance of BCD-054 (JSC BIOCAD, Russia) 120 mcg or 180 mcg~     intramuscularly, biweekly and Avonex® (Biogen Idec Limited, Great Britain) 30 mcg, weekly,~     for treatment of patients with remitting multiple sclerosis~   "
23908|NCT02744209|"~     This study will test whether immune functions in individual cancer patients can be~     characterized in a quantitative manner using new technologies that analyze nucleic acids~     from peripheral blood cells and whether those quantitations can be used to predict the~     response outcomes of patients being treated with Pembrolizumab.~   "
23909|NCT02744196|"~     The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in~     a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active~     RA seropositive previously untreated with biological therapy, compared to standard therapy~     with methotrexate.~   "
23910|NCT02744183|"~     In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the~     amount released from the liver. At the same time, skeletal muscles increase the rate at~     which they remove the glucose from the bloodstream, via the actions of the hormone insulin.~     This ensures that blood glucose levels remain in a controlled range. However, in developed~     countries, diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent,~     due to dietary modifications and a reduction in physical activity. As one of the prominent~     barriers to regular physical activity is a lack of time, finding ways to maximize the health~     benefits of exercise is a priority for researchers.~      The investigators want to understand potential differences in the effects of six weeks of~     aerobic training, with the exercise performed either after breakfast or after a prolonged~     fast. Specifically, this research aims to investigate whether there is a difference in the~     change in processes implicated in glucose regulation and secondly, in subsequent eating and~     physical activity behaviors. By investigating these changes this work will explore how~     exercise and nutrition can be optimized to benefit health and weight loss.~   "
23911|NCT02744170|"~     Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by~     increasing oxygenation and reducing dyspnea. In clinical practice there are three common~     oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with~     liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The~     CF involves considerable wastage of oxygen because oxygen is supplied during in- and~     exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen~     saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via~     demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In~     addition, it has to be considered that the lower weight of demand oxygen delivery system~     might enable patients for higher physical activity level and mobility in daily life.~      The effects of These three oxygen delivery systems shall be investigated by a randomized,~     controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test~     and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF,~     DDL or DDK) in randomized order.~   "
23912|NCT02744157|"~     The aim of the present study was to describe a structured intervention to reduce~     cardiovascular risk in a clinical setting and to study the effects of the program on~     lifestyle habits and quality of life in individuals at risk after six months and one year.~   "
23913|NCT02744144|"~     The purpose of the study is to explore the microbiology in war-associated wounds of~     hospitalized patients from the Syrian armed conflict. Cultures collected from acute wounds~     with clinical signs of infection will be analyzed.~   "
23914|NCT02744131|"~     Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E&P~     cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS(~     polycystic ovary syndrome)women from India.~      Intervention:~      Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with~     BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for~     getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged~     menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at~     enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference,~     Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks),~     Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid~     Profile, FAsting blood sugar & 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25-~     hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)~      Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood~     sugar); GTT(glucose tolerance test)~   "
24738|NCT02733367|"~     This is a Phase 3, open-label, single-group, non-randomised, observational study of the~     safety and biochemical disease control of Infacort® in neonates, infants and children with~     AI who have completed study Infacort 003. All subjects who have satisfactorily completed~     study Infacort 003 will be offered the opportunity to take part in Infacort 004.~   "
23915|NCT02744118|"~     This study adapts the Public Health Service (PHS) 5As model for use with adolescent~     marijuana users and pilot the intervention to test feasibility and acceptability in~     pediatric primary care settings. The specific aims are as follows:~      Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based~     on the Public Health Service 5As model and previously developed adolescent smoking cessation~     intervention.~      Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling~     intervention for adolescents.~      Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief~     counseling intervention in pediatric primary care practice.~      Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable~     for addressing marijuana use in routine clinical visits with adolescents and their families;~     and~      Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to~     be acceptable in the context of routine preventive services delivery.~   "
23916|NCT02744105|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is~     a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients~     regardless of the degree of iron overload. There is evidence that suggests Spirulina may~     help to protect against liver damage, cirrhosis and liver failure in those with chronic~     liver disease.~   "
23917|NCT02744092|"~     The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin~     vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention~     strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban,~     or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin.~     The information gained will empower cancer patients and physicians to make more informed~     choices about anticoagulation strategies to manage VTE.~   "
23918|NCT02744079|"~     Women post breast mass biopsy with ER+ cancer will be randomized to two diets--45 of them to~     a ketogenic insulin inhibiting diet, 20 to a low fat diet simulating their existing diet,~     but with added fruits and vegetables. The initial biopsy will be evaluated along with the~     surgical specimen pathology to compare changes in biomarkers, particularly of proliferation~     (Ki-67) and apoptosis (TUNEL).~   "
23919|NCT02744066|"~     Before they are born, babies are protected from hearing very loud noises by their mother's~     bodies. After delivery, they are exposed to many loud noises that are potentially harmful.~     These noises happen in the neonatal intensive care unit (NICU). The purpose of this research~     project is to test the fit and the ease-of-use of a new device that may protect infant's~     hearing in the NICU.~   "
23920|NCT02744053|"~     The goal of this clinical research study is to learn if investigational imaging scans can~     help researchers predict which patients may respond to treatment. The results of these~     investigational scans will be compared to the results of standard digital mammograms (DMs)~     and ultrasound (US).~      The investigational imaging scans being used on this study are:~        -  Tc99m Sestamibi Molecular Breast Imaging (MBI), and~        -  Dynamic Contrast Enhanced Molecular Resonance Imaging (DCE-MRI).~   "
23921|NCT02744040|"~     The overall objective is to determine the influence of timing of ART initiation and alcohol~     consumption on HIV disease course, including detailed analysis of important events occurring~     shortly after HIV acquisition. ART initiation immediately after HIV infection (during Fiebig~     stages I-II) largely results in smaller HIV reservoir and lower HIV-associated systemic~     inflammation, which has been linked to non-AIDS morbidity and mortality. Immediate ART also~     reduces HIV-associated bacterial translocation and may prevent dysbiosis, an alteration of~     the intestinal microbiota that has been linked to increased systemic inflammation. Immediate~     intervention is not, however, generally feasible and more information is required about the~     consequences of starting ART at later time-points, but still early after acquisition. The~     proposed study will be conducted in Lima, Peru, in the cohort of 180 MSM with acute (Ab-,~     HIV RNA+) or recent (≤ 3 months) HIV infection. Alcohol use disorder is present in ~50% of~     HIV-infected MSM in our cohort, which is four times higher than that seen among males in the~     general Peruvian population. Although the role of alcohol use in HIV pathogenesis and~     disease course remains unclear, some studies show a correlation with accelerated disease~     progression. In animal models and clinical studies, both acute and chronic alcohol~     consumption have been linked to bacterial translocation and activation of the innate immune~     system, which can lead to increases in pro-inflammatory cytokines. The effects of alcohol~     resemble early post-infection changes in bacterial translocation and pro-inflammatory~     cytokines induced by HIV and their impact on HIV disease course before and after ART~     initiation remain unexplored.~      Specific Aim 1: To determine the relative long-term benefits of immediate vs. early vs.~     delayed ART initiation. The investigators will study outcomes after 1.5 and 3.5 years in MSM~     diagnosed with acute or recent HIV infection. The investigators will examine outcomes in 3~     groups based on time of ART initiation: a) immediate: during FI-II (N~30), b) early: during~     FIII-V (N~50) or c) delayed: at 24 weeks after diagnosis (N~80). The investigators~     anticipate that CD4+ T cell counts and peripheral inflammatory markers in the FIII-V group~     and the delayed group will approach those in the immediate treatment group (FI-II) over~     time; in contrast, they expect that those started ART at early or delayed time points~     will have persistent changes in the GI microbiome and in the HIV reservoir.~      Specific Aim 2: To determine the impact of alcohol use on the relative long-term benefits of~     immediate vs. early vs. delayed initiation of ART. The investigators will examine the impact~     of alcohol use on critical events in HIV infection. They hypothesize that dose-dependent~     alcohol-induced changes will compound the negative effects of HIV and lead to greater levels~     of dysbiosis and inflammation, higher early plasma HIV RNA, and greater seeding and~     persistence of HIV DNA in participants with high-level alcohol use. The investigators will~     assess viral load, GI microbiome and metagenomics, pro-inflammatory cytokines, production of~     msRNA and analyze the impact on alcohol use in all subjects prior to ART initiation and~     among ART-adherent participants with persistent viral suppression.~   "
23922|NCT02744027|"~     Lymphatic Anomalies (LA) is characterized by proliferation of lymphatic tissue causing~     deterioration of pulmonary function. Understanding changes in lymphatic anatomy in these~     patients is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast~     Enhanced MR Lymphangiogram (DCMRL) may be useful in investigating pathological changes in~     the lymphatic system.~   "
23935|NCT02743858|"~     This study is being done to find out how many women develop lymphedema after an axillary~     lymph node dissection. The investigators also want to look for reasons why some women get~     lymphedema and others don't. Specifically, the investigators want to do tests on the breast~     tissue that is removed at the time of surgery to see if they can identify inflammation in~     the breast tissue, which may increase a woman's risk for lymphedema. The investigators will~     also ask the patient to answer questions to see how much their quality of life is affected~     by lymphedema, and whether this study can help women by detecting lymphedema earlier.~   "
24081|NCT02741960|"~     This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and~     safety of add-on metformin to conventional immunosuppressants in systemic lupus~     erythematosus (SLE).~      The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease~     flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of~     metformin on body mass index (BMI); 4) the safety of metformin.~   "
24764|NCT02733029|"~     The purpose of this study is to determine the feasibility and efficacy of detecting kidney~     transplant rejection using contrast enhance ultrasonography with the contrast agent~     Sonazoid.~   "
23923|NCT02744014|"~     Rationale: Recent investigations suggest that, through certain concentration/meditation~     techniques, it is possible to modulate autonomic activity. The results of a recent~     randomized controlled trial investigating the Wim Hof Method have shown a direct~     biological effect on in-vivo cytokine production and are strongly encouraging the clinical~     evaluation of the technique's efficacy in immune-mediated inflammatory diseases.~      Objective: To investigate whether an add-on mindset & physical therapy program based on the~     Wim Hof Method can safely and efficaciously be applied in patients with active axial~     spondyloarthritis.~      Study design: Prospective open-label randomized controlled trial, safety and efficacy.~      Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45~     years of age.~      Intervention: A 30-day training program of add-on mindset and physical therapy for axial~     spondyloarthritis, using the methodology as designed and instructed by Wim Hof. It involves~     breathing techniques, training of mindset and concentration, and gradual cold exposure.~      Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the~     study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives~     include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D),~     depressive symptoms (HADS), and predictive role of generalized and specific outcome~     expectancies (EPQ-N, LOT-R, VAS scales).~   "
23924|NCT02744001|"~     The purpose of this study is to determine how daily diet relates to eating choices.~   "
23925|NCT02743988|"~     In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for~     supplemental oxygen will be randomized to either Sequence of two different oxygen target~     ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation,~     cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary~     outcome is time with arterial oxygen saturation < 80%.~   "
23926|NCT02743975|"~     There is a need for better visualization of resection margins and detection of small tumor~     deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic~     ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this~     need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in~     pancreatic cancer tissue versus normal tissue and has proven to be a valid target for~     molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal~     antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The~     investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer,~     enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this~     pilot intervention study the investigators will determine the optimal dosage of~     bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.~   "
23927|NCT02743962|"~     Bladder pain syndrome is a condition where pain is experienced when the bladder fills with~     urine and eases briefly when the bladder empties. There can also be a constant need to~     urgently empty the bladder.~      The internal pelvic floor muscles in people with bladder pain syndrome can be tense and~     painful, and relaxing and stretching them may improve symptoms; reducing bladder pain,~     urgency and how often people have to empty their bladder.~      This pelvic floor release is done by specialist physiotherapists.Therapeutic wands, such as~     the TheraWand®, are used routinely throughout the United Kingdom to allow people to relax~     and stretch their pelvic floor themselves. Using a therapeutic wand has been shown to be~     safe and to reduce pelvic pain, improve bladder and bowel symptoms and relax the pelvic~     floor muscles. However, this research was conducted mostly in men with pelvic pain.~      The aim of this study is to find out if using a therapeutic wand at home as well as having a~     specialist physiotherapist massage the pelvic floor gives any added benefit than just having~     the physiotherapy treatment. The investigators hope to find out if the therapeutic wand~     gives women a way of managing their symptoms independently in their own homes.~   "
23928|NCT02743949|"~     The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole~     for preventing heartburn symptoms over a 4-week treatment period in participants who have a~     partial response to treatment with esomeprazole.~   "
23929|NCT02743936|"~     This is a prospective randomized cross over study of healthy volunteers undergoing~     continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask~     with and without the addition of nasal cannulas. Mask leak will be measured by the~     ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as~     his or her own control.~   "
23930|NCT02743923|"~     The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results~     in a prolonged progression free survival compared to cisplatin-pemetrexed as first line~     treatment in patients with KRAS mutated non-small cell lung cancer.~   "
23931|NCT02743910|"~     This study is being done to see if it is possible to use blood samples to predict response~     to treatment in breast cancer patients receiving preoperative (or neoadjuvant) therapy.~     Research has shown that most breast cancers release tumor-specific DNA into the blood (that~     is, DNA that is specific to the tumor cells or cancer). This DNA can be detected in blood~     testing known as plasma tumor-DNA or ptDNA. This DNA is separate from that found in the~     blood and tissue samples which serve as the instruction book or genetic code for the~     cells that make-up the human body. The changes in ptDNA before and after treatment, as well~     as after surgery, may also help investigators to understand more about a patient's risk of~     cancer returning and long-term outcomes.~   "
23932|NCT02743897|"~     This study is being conducted to determine safety and effectiveness of transplanting kidneys~     from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant~     waitlist, who will then be treated with Zepatier after the single kidney transplantation.~   "
23933|NCT02743884|"~     An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each~     patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of~     warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be~     heat transfer, determined from inflow and outflow temperatures and fluid flow rate for~     cooling and warming modes.~   "
23934|NCT02743871|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-06817024 in healthy volunteers who may be mildly atopic and in~     participants with chronic rhinosinusitis with nasal polyps~   "
23936|NCT02743845|"~     The Gene Discovery Core at The Manton Center for Orphan Disease Research based at Boston~     Children's Hospital studies families with rare, poorly understood or undiagnosed, but~     suspected genetic conditions. The primary goal of the research is to better understand the~     genes and proteins (gene products) involved in rare diseases. The researchers hope that our~     studies will allow for improved diagnosis and treatment of individuals with rare disease in~     the future. Individuals with any rare/undiagnosed condition are eligible to enroll.~      Enrollment includes:~        -  Providing DNA and tissue samples (when available)~        -  Access to participants' medical records~      Samples are used for genetic analysis (primarily exome and genomce sequencing) to identify~     the genetic cause for the individual's illness. Individual research results are returned to~     families through their health care provider after confirmation in a clinical lab. If a cause~     is identified, that can be reported back to the family through their health care provider~     and the study's genetic counselor. When possible, the investigators also collect samples~     from parents and full-siblings as well as any other affected family members.~   "
23937|NCT02743832|"~     The purpose of this study is to determine whether cervical lymph node dissection is~     necessarily performed in the presence of early-stage oral squamous cell carcinoma.~   "
23938|NCT02743819|"~     Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and~     anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the~     response rate of the combination and evaluate other clinical parameters such as~     progression-free survival and safety of the combination following anti-PD1/L1 antibody. The~     study will also provide the opportunity to investigate blood or tumor based factors that may~     predict response to anti-PD1 antibody in combination with anti-CTLA4.~   "
23939|NCT02743806|"~     The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis~     (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects~     who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for~     whom continued treatment with vedolizumab is desired because there is no other comparable~     product available or the subject may be expected to develop worsening of disease if they~     were to modify treatment.~   "
23940|NCT02743793|"~     Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ~     transplant recipients to prevent their bodies from rejecting the new organ. Some organ~     transplant recipients can stop taking anti-rejection medicines without rejecting their~     transplanted organ (this is called 'tolerance'). The purpose of this study will collect~     samples and data from 'tolerant' liver or kidney transplant recipients in order to find out:~      The purpose of this study is to collect samples and data in order to find out:~        -  How long liver or kidney transplant recipients can remain tolerant;~        -  What happens in the tolerant recipient's body over time; and~        -  If there are patterns in the body that are linked to tolerance.~   "
23941|NCT02743780|"~     The purpose of this study is to determine if the clinical profile of topical-ocular MGV354~     merits further development for the indication of lowering intraocular pressure (IOP).~   "
23942|NCT02743767|"~     The purpose of this study is to determine if five simple adaptations in airway management of~     patients undergoing general anaesthesia can reduce minor and major airway complications.~      After a first detection of causes of airway complications during general anaesthesia~     investigators initiated five different interventions in airway management, which were:~     immediate bag-valve mask ventilation after administering of muscle relaxants, optimized~     preoxygenation, introducing of a preinterventional checklist, increased usage of video~     laryngoscopy and immediate change of provider in case of failed intubation.~      In a second phase of this observational study investigators want to evaluate if these five~     interventions can reduce minor and major airway complications during general anaesthesia.~      Additionally, investigators want to record how many critical incidents (CIRS) occur during~     this observational period and how many of them will be reported by the involved stuff.~   "
23943|NCT02743754|"~     Kidney injury is a serious complication of cardiac surgery that occurs in up to 30% of~     patients and increases the risk of adverse outcomes. Kidney injury initiates when oxygen~     supply to the kidney drops below levels that are needed for normal cellular function,~     causing tissue oxygen deficiency (hypoxia), activation of the inflammatory cascade, and~     oxidative stress. Together, these events further impair tissue oxygenation, culminating in~     impaired kidney function due to cellular injury and death.~      There are no effective therapies for kidney injury after cardiac surgery, but there is~     evidence that recovery is possible if the processes of injury - i.e., impaired oxygen~     delivery, increased inflammatory response, and oxidative stress - are ameliorated soon after~     the onset of injury. Hyperbaric oxygen therapy (HBOT) - which entails the intermittent~     inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than one absolute~     atmosphere (> 760 mmHg) - has been shown to positively affect all of these processes (i.e.,~     to improve tissue oxygenation, reduce inflammation, and reduce oxidative stress). Thus, we~     hypothesized that HBOT will reduce the severity of kidney injury after cardiac surgery if it~     is initiated soon after onset of injury. This hypothesis has not been tested in humans, but~     is supported by animal studies.~      In this first-in-human, unblinded, controlled pilot trial, 20 adult patients who develop~     severe kidney injury soon after cardiac surgery will be randomized (after obtaining informed~     consent from the patient or surrogate) to standard-of-care or early HBOT. Severe kidney~     injury will be defined as a ≥30% drop in kidney function within 6 hours of surgery (as~     determined by change in creatinine from before surgery to Intensive Care Unit (ICU)~     admission). This degree of injury occurs in ~ 2% of patients and is associated with a~     12-fold increase in the risk of complete kidney failure (requiring dialysis) or death.~     Patients will be excluded if they have any relative or absolute contraindications to HBOT~     (e.g., severe ventricular dysfunction, ventricular assist device, severe respiratory~     dysfunction, pneumothorax, bronchospasm).~   "
23944|NCT02743741|"~     This is a prospective single arm, multicenter study will evaluate the efficacy and safety of~     Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin~     receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has~     progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible~     patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will~     undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based~     on individualized dosimetry, as well as creatinine clearance and hematological parameters.~     Patients will be evaluated progression free survival at 12 months from last dose. Patients~     who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be~     followed until progression and acts as control group.~   "
24094|NCT02741037|"~     Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The~     proposed study tests a novel intervention that capitalizes on an existing important family~     dyad (mothers and their adult daughters) to foster clinically significant and long-lasting~     health behavior change. If found to effective, this intervention strategy has great~     potential to address health disparities in this, and other, at-risk populations.~   "
23945|NCT02743728|"~     The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but~     little is known about the resulting changes in the brain that eventually manifest as~     cerebral palsy (CP). More importantly, no therapy has been devised to mitigate these~     specific maladaptive changes leading to hemiplegic CP. However, motor signs that indicate~     the infant is beginning to develop CP often do not become evident for several months after~     the diagnosis of perinatal stroke. This delays therapy. We view the first several months~     after perinatal stroke as a window of opportunity because it is known to be a critical~     period of development. During this period, a well-designed intervention could minimize~     maladaptive changes in the brain. To design such a science-based rehabilitation protocol for~     young infants during this window of opportunity, we must first develop efficient and~     reliable assessments to detect and measure maladaptive cortical reorganization in the brain.~      Therefore, the main purpose of this study is to examine early brain reorganization in 3-5~     months old infants with unilateral perinatal stroke using magnetic resonance imaging (MRI)~     and non-invasive transcranial magnetic stimulation (TMS). In addition, the association~     between the brain reorganization and motor outcomes of these infant participants will be~     identified.~      In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established~     method used to investigate the integrity of pathways in the brain that control limb~     movement. Infants will be scanned during nature sleeping after feeding. The real scanning~     time will be less than 38 minutes. TMS is a painless, non-surgical brain stimulation device~     which uses principles of electromagnetic induction to excite cortical tissue from outside~     the skull. Using TMS as a device to modulate and examine cortical excitability in children~     with hemiparetic CP and in adults has been conducted previously. In this infant study, we~     will assess cortical excitability from the motor cortex of both the ipsilesional and~     contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation~     system. Additionally, the investigators will assess infants' spontaneous movement quality~     using the General Movement Assessment (GMA) procedure. This will allow the investigators to~     examine the relationship between measures of motor pathway integrity and early signs of~     potential motor impairment.~   "
23946|NCT02743715|"~     Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have~     expanded with the greater understanding of the brain circuits involved in this disorder.~     Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique~     that has been studied as an alternative for strategy for treatment-resistant OCD. The main~     study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients~     unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors.~     Forty-four patients will be randomized to two groups: active or simulated intervention. The~     intervention consisted of delivering an electric current of 2mA to the cathode, positioned~     bilaterally in the cranial region corresponding to the supplementary motor cortex, and the~     anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive~     weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of~     tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms,~     genetic markers, motor cortical excitability and performance in neurocognitive tests.~   "
23947|NCT02743702|"~     The main objective of this study is to determine whether the Respiratory Physiotherapy~     allows improvement or maintenance of respiratory function in children with Neuromuscular~     Diseases, against respiratory deterioration that occurs in the group of subjects who did not~     receive this treatment. And to determine whether decreasing the number of respiratory~     infections and secondly the need for antibiotics and the number of emergency room visits and~     hospital admissions related to these.~   "
23948|NCT02743689|"~     The aim of the study is to identify the incidence of early postoperative delirium in~     intensive care patients after cardiac surgery and detect possible risk factors associated~     with increased risk for developing delirium after cardiac surgery.~   "
23949|NCT02743676|"~     This is a global, multi-center, observational registry of participants with suspected or~     confirmed infection with avian influenza A H5N1. Data are collected through retrospective~     abstraction, from detailed case reports that may be published and available in the public~     domain, or as incident cases received directly from the treating physician or other medical~     personnel.~   "
23950|NCT02743663|"~     The study will ascertain the ability of preschool lung function tests to distinguish healthy~     children from those with wheeze, and to differentiate phenotypes of wheezy children (high~     and low risk for asthma as defined by API) in order to predict response to therapy, and to~     explore the correlation between preschool lung function test results and symptoms, in order~     to develop objective methods for monitoring asthma.~   "
23951|NCT02743650|"~     The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low~     serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants~     will take sodium bicarbonate for six weeks, followed by a four week washout period.~   "
23952|NCT02743637|"~     This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated~     dose of subcutaneous administered SDX-7320 in patients with advanced refractory or~     late-stage solid tumors.~   "
23953|NCT02743624|"~     The indications for mechanical ventilation (MV) include excessive work of breathing, with or~     without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge~     because it is based on criteria understudied, often subjective and observer-dependent.~     Despite several studies, to our knowledge has never been done before is the precise~     definition of the optimal range of ventilatory support. Novel and recognizable diagnostic~     techniques will be applied. No single parameter of the breathing pattern has good accuracy~     for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of~     muscle relaxation may have good accuracy for the adjustment of ventilatory support.~   "
23954|NCT02743611|"~     This study will evaluate patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)~     or advanced hypomethylating agent-resistant myelodysplastic syndrome (MDS) who will have~     autologous immune cells, called T cells, collected via apheresis. The study will assess~     whether the specially grown T cells, grown in the laboratory, are safe when given back to~     the patient. As a safety measure these T cells have been programmed with a self-destruct~     switch so that they can be destroyed if they start to react against tissues (Graft versus~     host disease). Another goal is to potentially identify a dose which might provide some~     activity in the patient.~   "
23955|NCT02743598|"~     This study will test the effect of liraglutide on cognitive function in HIV-infected~     overweight or obese subjects with type 2 diabetes.~   "
24129|NCT02741479|"~     The purpose of this research is to determine if a specific type of elasticated athletic tape~     (Kinesio Tex Tape) increases muscle activation among professional level dancers.~     Investigators will determine if changes in muscle activation with the elasticated tape~     differ from changes experienced with no tape and/or sham tape, and if it coincides with~     subjective sense of muscle activation.~   "
24130|NCT02741466|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
23956|NCT02743585|"~     Septic shock carries high mortality, which may be exacerbated by inappropriate initial~     therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance.~     Conversely, positive blood cultures may result from contamination, leading to unnecessary~     therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to~     broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility~     results.~      The investigators hypothesize that rapid identification of pathogens and antimicrobial~     resistance will ameliorate the above problems and improve time to optimal therapy, avoid~     unnecessary therapy and ultimately improve patient outcomes. While there are a number of~     in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical~     trials objectively examining the real-world clinical and health-economic impact of such~     technology. To date only one randomised trial has been performed in the US~     (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial~     resistance. This is a companion study to NCT01898208. The investigators aim to study the~     clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance~     detection in a setting with a moderate to high levels of antimicrobial resistance.~   "
23957|NCT02743572|"~     The purpose of this study is to determine whether iron-fortified PN is effective in the~     preventative and treatment of preterm infants. Preterm infants are at risk for anemia~     especially in preterm infants. Anemia effects growing development, clinical prognosis,~     cognition, movement, learning ability and behavioral development.~      As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral~     iron administration is an efficacious method for investigators to select. For most preterm~     infants, the use of parenteral nutrition(PN) is very common during the first ten days of~     life, so the investigators hypothesis that iron-fortified PN may have a preventative and~     treatment effect on preterm infants using PN as a supplementation of oral nutrition;~     Iron-fortified PN can also improve iron store status of preterm infants. The higher~     concentration of iron used in this study, the larger preventative or treatment effect on~     preterm infants anemia; it is safe to add small dose of iron agent to PN.~   "
23958|NCT02743559|"~     Fractures in children are common and the incidence is increasing. They are more common in~     children who have small, narrow and weak bones. Studies have shown that fractures in early~     childhood are associated with later bone strength.~      There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable~     factors such as nutrition (vitamin D & calcium intake) and exercise that can contribute to~     bone strength.~      Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role~     in bone health by increasing the absorption of calcium from the gut. Investigators know from~     the previous research that there is a reduction in bone strength in children whose mothers~     had lower vitamin D levels during pregnancy.~      Bone growth can also be achieved by loading of bone during childhood in the form of regular~     sport activities such as gymnastics and exercise programmes. Equally it can be achieved by~     using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body~     in a synchronous fashion by which the bones are made much stronger reducing the risk of~     fracture in later life. Thus WBV can be used as a means to assess bone responsiveness to~     mechanical stimulation. Studies have shown that standing on a vibrating platform for 10~     minutes a day can significantly increase the bone mass. Investigators' own research has also~     shown that healthy boys when made to stand on a vibration platform for 10 minutes daily for~     5 days increased the strength and quality of their bones.~      Thus the role of diet and mechanical loading are of considerable interest in determining~     their role in bone health and the prevention of fractures.~      Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3~     different big centres (Sheffield, Southampton and Oxford). Results from this study have~     shown that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of~     pregnancy increased the strength of the bones in their infants. In the proposed study~     Investigators aim to show how vitamin D supplementation during pregnancy affects the~     response of bone to vibration in children whose mothers participated in the MAVIDOS study in~     Sheffield. These children will be 4 years of age when they participate in this study.~      The results of this study will help inform public health policy on vitamin D intake during~     pregnancy. This will also help the investigators identify a possible risk factor for poor~     bone health in children.~   "
23959|NCT02743546|"~     The purpose of this study is to determine whether duvortuxizumab and ibrutinib can be~     combined safely and to establish the maximum tolerated dose (MTD) in Part 1 and the~     recommended Phase 2 dose (RP2D) and to further explore the safety of duvortuxizumab in~     combination with ibrutinib at the RP2D in participants with diffuse large B-cell lymphoma~     (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic~     leukemia (CLL) in Part 2.~   "
23960|NCT02743533|"~     The Silesian Cardiovascular Database is an observational study of all patients hospitalized~     due to cardiovascular diseases. The date include information on the clinical~     characteristics, treatment modalities and prognosis in this population.~      The data include information on all the applicable diagnostic and therapeutic procedures,~     prognosis and hospitalization costs. Likewise, data have been collected specialist care~     outpatient visits and primary health care patients were hospitalized.~   "
23961|NCT02743520|"~     The purpose of this research study is to learn about arrhythmia detection in obstructive~     sleep apnea (OSA). For several years patients with OSA have an increased likelihood of~     having irregular heartbeats. This study will determine how often patients with OSA have~     irregular heartbeats. This study will also define which OSA patients are most likely to have~     irregular heartbeats.~      The participant is being asked to be in the study because the participant has been diagnosed~     with obstructive sleep apnea (OSA).~   "
23962|NCT02743507|"~     Bundled payment is a new payment reform that encourages health care providers to improve~     quality and contain costs of care. These arrangements are being rapidly expanded across the~     country, but evidence about their impact are lacking. This study will use Medicare claims~     data to evaluate the effect of participation in a large Medicare bundled payment program on~     the quality and costs of care for common medical and surgical conditions.~   "
23963|NCT02743494|"~     The purpose of this study is to determine whether nivolumab will improve overall survival,~     disease-free survival, or both compared with placebo.~   "
23971|NCT02743390|"~     Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of~     concurrent use of three or more antihypertensive agents of different classes, combined at~     optimal doses. Currently it has been largely discussed the influence of inflammation in RH.~     The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor~     necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α~     inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients~     with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in~     RH subjects compared to normotensives. This study aims to assess whether the acute~     inhibition of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.~   "
24186|NCT02740582|"~     The purpose of this study is to determine the effects of tolcapone on decision making and~     alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol~     drinkers.~   "
23964|NCT02743481|"~     Background:~      The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and~     Iowa. It also included people who worked with pesticides in Iowa. They answered a~     questionnaire and gave data about their children born since 1975. Researchers want to link~     this data to public data like birth and death certificates. They want to study how early~     life exposures to farms are linked to cancer and other bad health outcomes.~      Objective:~      To study data to find links between early life farm exposure and negative health outcomes.~      Eligibility:~      There will be no human subjects.~      Design:~      Researchers will get public data in the two study states. This will come from things like:~      Birth certificates~      Driver s licenses~      Voter registration~      Death certificates~      Based on these plus the AHS data, they will create a study group. It will be called Early~     Life Exposure in Agriculture (ELEA).~      Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.~      They will study parents answers on the AHS. The topics include farm practices and pesticide~     use. They will determine ELEA exposure to pesticides.~      Researchers will analyze the cancer and pesticide results and look for links.~   "
23965|NCT02743468|"~     Background:~      Respiratory diseases affect more than 1 billion people worldwide. They are a growing public~     health concern. The lungs are constantly exposed to environmental factors such as dust,~     fumes, microbes, and pollutants. But much is still not known about how these pollutants lead~     to respiratory illnesses. Researchers want to collect samples from lungs and blood to see~     how genetics and environmental pollutants affect cellular responses or functioning.~      Objectives:~      To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the~     lungs and inflammatory responses.~      Eligibility:~      Adults ages 18 60 who can have a bronchoscopy.~      Design:~      All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle~     Park, NC.~      At study visit 1, participants will be screened with medical history and physical exam. They~     will have blood and urine tests. They will take tests that measure their lung function. They~     will answer questionnaires. Before the visit, they will be given a list of medicines they~     cannot take. They also must not have caffeine on the day of their visit. The visit will last~     about 3 hours.~      At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For~     this, they will get an intravenous line in a vein to get sedatives. Their airways will be~     numbed. Cells will be collected from their lungs. They will fast for 8 hours before the~     visit. They must have someone else drive them home from the visit. The visit will last about~     3-4 hours.~      Participants will get a follow-up phone call about 1 day after study visit 2.~   "
23966|NCT02743455|"~     This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate~     the safety, reactogenicity, tolerability, and immunogenicity of MVA-BN-YF in~     Flavivirus-naïve healthy male and non-pregnant female adult subjects. There are six dose~     groups in this study. Subjects who have never received a licensed or investigational~     smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up~     will be conducted in a double-blinded fashion. Subjects who have previously received two, 1~     x 108 TCID50 doses of MVA-BN between 19 and 45 days apart by SC or IM routes will be~     enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I~     study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one~     at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with~     or without ISA 720. Subjects and study personnel will be blinded as to whether ISA 720 was~     administered.~   "
23967|NCT02743442|"~     Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and~     anatomic limits have been widened in order to extend neurosurgical applications. For many~     years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc,~     Sunnyvale, California, USA) has been greatly developed, especially in urology and~     gynecology.~      Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a~     minimally invasive perspective.~      A robot-assisted preliminary series demonstrated the ability to approach the sella via oral~     approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the~     complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and~     secondary atrophican rhinitis, and empty nose syndrome.~      The investigators recently published a cadaveric study of transoral robotic-assisted skull~     base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).~      In this study, the investigators will propose a new minimally invasive technique of~     pituitary surgery by transoral approach assisted by the da Vinci robot in patients with~     pituitary adenoma.~   "
23968|NCT02743429|"~     In this trial, monoclonal anti-Disialoganglioside GD2 (GD2) antibody ch14.18/CHO will be~     assessed for the treatment of patients with relapsed or refractory neuroblastoma. The~     antibody is used as a single agent applied in a new treatment schedule associated with less~     side effects.~   "
23969|NCT02743416|"~     The STROKESTOP II study is a proposed study to determine if the biomarker NT-proBNP together~     with single-lead ECG can be used as a primary population screening tool for silent atrial~     fibrillation, and builds on previous results from the STROKESTOP study.~   "
23970|NCT02743403|"~     The project aims to compare the use of carboxiterapia ( therapeutic administration of carbon~     dioxide) with the use of active TENS and placebo TENS using the VAS scale as a parameter.~     The therapy used was started in the 30s , with carbonated water baths, and , lately, is~     involved in the therapeutic arsenal of numerous diseases , Both for treatment of diseases~     when for aesthetic treatments , especially for the gynoid lipodystrophy. However, the~     therapy presents CO2 in clinical practice, limiting factors for its use , such as pain at~     the injection site , small bruises or welts due to several punctures and feeling of~     crepitus. To try to combat these  side effects  that can last up to 30 minutes, the TENS~     was used in order to determine whether the use of this electric current helps at improvement~     of discomfort.~   "
24002|NCT02742987|"~     CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study~     evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function~     and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with~     percutaneous coronary intervention (PCI).~   "
24003|NCT02742974|"~     The aim of this study is to determine if the incidence of post-operative complications can~     be decreased by the implementation of intra-operative, minimally invasive hemodynamic~     monitoring (MIHM) via FloTrac™ and EV1000™ in trauma patients.~   "
23972|NCT02743377|"~     Background:~      McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some~     hormone-producing tissues. It is associated with a mutation in a gene. This gene affects~     enzymes in the brain and body. Researchers want to learn more about one of these enzymes,~     Phosphodiesterase 4 (PDE4), in people with MAS.~      Objective:~      To see if people with MAS have higher levels of PDE4 than people without MAS.~      Eligibility:~      People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and~     Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright~     Syndrome. Healthy adult volunteers are also needed.~      Design:~      This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may~     take place on the same day.~      Participants with MAS will be screened with medical history and physical exam. They will~     have blood and urine tests.~      Participants will have a magnetic resonance imaging scan.~      Participants will have a full body positron emission tomography (PET) scan. A small amount~     of a radioactive chemical, [11C](R)-rolipram, will be given through an intravenous tube.~      Participants will have a brain PET scan with [11C](R)-rolipram. For this, a thin plastic~     tube will also be put into an artery at their wrist or elbow crease area.~      For the scans, participants will lie on a bed that slides in and out of a scanner. They may~     wear a plastic mask to hold their head in place. They will have blood drawn.~      Participants with MAS will be interviewed about their thinking and mood. They may complete~     questionnaires about how they feel or think.~   "
23973|NCT02743364|"~     This randomized phase II trial studies how well simvastatin works in reducing pancreatitis~     (the inflammation of the pancreas) in patients with pancreatitis that occurs more than once~     (recurrent), has worsened quickly (acute), or has persisted or progressed over a long period~     of time (chronic). Simvastatin may decrease the inflammation of the pancreas by modulating~     the immune response responsible for inflammation. It is not yet known if simvastatin may be~     an effective treatment for pancreatitis.~   "
23974|NCT02743351|"~     This study is a Phase 1 Non-randomized/Phase 2 Randomized, open-label, prospectively and~     historically controlled trial of the safety and efficacy of a single ProTmune ex vivo~     programmed mobilized peripheral blood (mPB) cells for hematopoietic cell transplantation~     (HCT) in adult subjects aged 18 to 70 years with hematologic malignancies. A maximum of 70~     total eligible subjects will be enrolled and treated in the trial at approximately 10-12~     centers in the US and EU.~   "
23975|NCT02743338|"~     This study includes two consecutive sub-trials.~      Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most~     important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but~     lately, adverse effects related to SR have been reported. A treatment method with~     similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears~     to have similar effects to SR but without the adverse effects. The first sub-trial thus aims~     at directly comparing SR and SC. The second sub-trial aims at evaluating any additional~     effects of CBT-i components given as an add-on treatment to a randomized selection of half~     participants in each original treatment arm.~   "
23976|NCT02743325|"~     Supraventricular tachycardia ablations of the Conformité Européenne (CE)-certified (since~     2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) allows a seamless combination~     of a fluoro image and Carto® 3 System maps into a single view. This helps to reduce~     fluoroscopy levels and reduce exposure time for physicians, staff and patients to as low as~     reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the~     conventional radiofrequency Ablation.~   "
23977|NCT02743312|"~     The goal of this pilot study is to test the protocol for investigating the longer-term~     effects of torso weighting on physical activity, number of falls, and muscle activation~     (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis.~     The hypotheses of this study include: torso weighting will (1) increase physical activity,~     (2) decrease the number of falls, and (3) improve the timing and coordination of muscle~     activation during balance perturbations.~   "
23978|NCT02743299|"~     The objective of this study is to determine whether healthcare professionals trained in CPR~     can deliver more effective ventilations during CPR using the Handivent, a novel~     turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model.~     The investigators believe the Handivent will deliver a more accurate respiratory rate and~     tidal volume, with lower intrathoracic pressure during CPR.~   "
23979|NCT02743286|"~     Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental~     to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous~     physical activity. The mechanisms that mediate this are unknown and there are no~     evidence-based methods known for effectively intervening on sedentary behavior. The~     consequences of prolonged sitting time are of particular interest in older adults as~     sedentary behavior and cardiometabolic disease risk both increase with aging and~     moderate-to-vigorous physical activity may not be feasible. This pilot study will assess~     interventions for sedentary older adults designed to interrupt prolonged sitting time.~     Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks~     increases muscle use and blood flow in the lower parts of the body. Thus, the investigators~     believe that frequent sit-to-stand interruptions of sitting time are the most efficacious~     sedentary behavior interventions, compared to simply reducing sitting time or less frequent~     walking breaks, for improving health outcomes and healthy aging. The investigators~     hypothesize that frequency of sit-to-stands during a 5-hour sitting period will result in~     health benefits that can be observed with a simple 2-minute standing interruption, and that~     this will be associated with improvements in metabolism and endothelial function. This~     pilot, 10-participant study will 1) generate preliminary data for a revised Program Project~     Grant application to the National Institute of Aging (NIA) that focuses on postmenopausal~     women, the fastest growing aged population with high life-time risk of cardiometabolic risk.~     This pilot study will inform sitting interruption modality design for two projects in the~     investigators' Program Project Grant application: Project 1: Sedentary Behavior~     Interrupted: A randomized crossover treatment trial of acute effects on biomarkers of~     healthy aging in the laboratory (86 participants) and Project 2: Sedentary Behavior~     Interrupted: A randomized trial of 6 month effects on biomarkers of healthy aging and~     physical functioning in the real world (660 participants). The current design of this pilot~     study is enhanced by and responsive to feedback from our initial NIA submission. This pilot~     study will increase our knowledge about how sedentary behavior and sitting interruption~     interventions influence healthy aging in postmenopausal women.~   "
24004|NCT02742961|"~     Pain is common after knee replacement surgery and can impact a variety of patient outcomes.~     Peripheral nerve blocks provide improved pain control and may improve function. However,~     their impact on other outcomes is poorly described. Therefore, this comparative~     effectiveness study will estimate the independent association between nerve blocks and~     health outcomes after knee replacement surgery.~   "
24187|NCT02740569|"~     Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary~     involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known~     regarding the prevalence of OSA in scleroderma and its association with pulmonary~     involvement.~   "
33989|NCT02612181|"~     The investigators preliminary study showed that dexmedetomidine might improve~     microcirculation in septic shock patients. To test this effect, the investigators will~     conduct double-blinded study.~   "
23980|NCT02743273|"~     Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum~     creatinine and a decrease in urine output. However, applying this definition to neonates~     remains challenging because of the normal renal physiologic features that serum creatinine~     levels are expected to increase in the first days after birth, and impaired sodium~     reabsorption and concentrating ability.~      Because of several limitations of early detection of AKI, investigators are focused on~     identifying biomarkers that predict AKI before an increase serum creatinine level.~      Investigators will collect urine from preterm infants before and after administrating~     ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators~     will analyze urine by proteomics. To verify those biomarkers, investigators will use initial~     urine on the first day of life from preterm infants who diagnosed AKI within 7 days after~     birth without any risk factors for AKI and enrolled institutional bio-repository.~   "
23981|NCT02743260|"~     The objective of the present study is to contribute to establishing in vivo phenotyping~     procedures for organic anionic transporter polypeptide 1B1 (OATP1B1), organic cation~     transporters 1 and 2 (OCT1/2), multidrug and toxic compound extrusion transporters 1 and~     2,kidney splice variant (MATE1/2K), organic anion transporters 1 and 3 (OAT1/3), and~     p-glycoprotein (P-gp) transporters via a cocktail approach. To this end, marker substrates~     for each of the respective transporters are administered as single doses in one period each~     and as a cocktail in one period to 24 healthy volunteers, and phenotyping metrics are~     derived from plasma and urine concentrations.~   "
23982|NCT02743247|"~     Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney~     transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil,~     therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic~     interplay between two drugs enables fine dose adjustment, while mechanism of drug~     interaction between two drugs is still not well understood. Therefore, an open-label, three~     period, single dose trial is planned to investigate the drug interaction between tacrolimus~     and mycophenolate mofetil.~   "
23983|NCT02743234|"~     Randomized open label clinical trial to compare the clinical and microbiological efficacy of~     fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium~     difficile infection~   "
23984|NCT02743221|"~     The main purpose of this study is to evaluate the progression-free survival (PFS) in~     patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab~     (control arm) as first-line treatment for metastatic colorectal cancer in patients~     non-eligible for intensive therapy.~   "
23985|NCT02743208|"~     In recent years, short femoral stems have been introduced. Short stems are designed based on~     traditional stems with good clinical results. The assumed benefit of short stems is that~     they are easier to use in mini-invasive surgery, and that preservation of proximal~     periprosthetic bone stock is better. Preservation of periprosthetic bone in the proximal~     femur is thought to secure long time anchoring of the implant, and reduce the risk of~     loosening. In addition, a good proximal bone stock makes later revision surgery less~     technically demanding. However, the short stem design could compromise the stability of the~     prosthesis, and there has been reported diverging results regarding correct positioning of~     short stems. This may be due to the lack of inherent aiming provided by the tip of the~     traditional long stems. We want to clinically evaluate the stability and bone remodelling~     pattern of a new short femoral stem based on a standard stem with excellent long time~     results. In addition we will compare the two different stems regarding positioning, when~     using a newly developed guiding broach for the short stem, and the standard broach for the~     long stem. Finally, patient reported clinical outcome scores will be evaluated with respect~     to implant and biomechanical reconstruction.~      The aim of this study is to evaluate whether this specific short femoral stem is stable,~     safe to use, and if it provides the expected beneficial effects on bone remodelling.~   "
23986|NCT02743195|"~     The gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and~     tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and~     greater number and diversity of non-beneficial bacteria occurs with age and conditions~     associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the~     microbiota contributes to increased inflammation of the gastrointestinal lining and changes~     to the integrity of the intestinal cell wall.~      Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity~     microorganisms that contribute to the well-being of the host. Recent studies have shown that~     prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and~     inflammatory markers in an obese population(3). The polyphenol blend is rich in~     anthocyanins, which is a unique subgroup of flavonoids that have been demonstrated to impact~     the microbiome and have anti-inflammatory properties(4,5,6,7). This open-label study will~     assess the benefits of a prebiotic and polyphenol blend in healthy obese adults.~   "
23987|NCT02743182|"~     Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common~     form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients~     includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon~     (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen s~     (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has~     been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high~     probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine~     HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg~     loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety~     adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.~   "
24043|NCT02742454|"~     The purpose of this study is to determine whether providing ventilatory assistance prior to~     umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in~     extremely preterm (EPT) infants, compared to standard care of providing ventilatory~     assistance after cord clamping.~   "
24044|NCT02742441|"~     This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and~     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with~     plaque psoriasis.~   "
24201|NCT02740387|"~     This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral~     Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at~     3-month intervals for a total of 4 injections total.~   "
23988|NCT02743169|"~     The investigators hypothesize that spatial analysis of the location data of ambulance calls~     can improve prehospital care provided by Aman Foundation in Karachi, Pakistan by decreasing~     ambulance response times for high acuity patients. In Aim 1, the investigators will develop~     a conceptual framework for prehospital care in low- and middle-income countries (LMICs) to~     anchor our project in Aims 2 and 3. In Aim 2, the investigators will analyze the location of~     calls to identify geographic areas with delayed responses for patients with higher severity~     of illness. As part of their quality assurance/quality improvement practices, Aman~     Foundation routinely collects location data from GPS devices in their ambulances for each~     call. Based on the analyses in Aim 2, in Aim 3 the investigators will position ambulances~     where there are clusters of delayed ambulance calls for high acuity patients to improve~     response times. This period will be compared with a previous, control period and will be~     analyzed to identify possible new clusters.~   "
23989|NCT02743156|"~     Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous~     coronary interventions. Despite various efforts, very few preventive measures have been~     shown effective in reducing its incidence.~      The final volume of contrast media utilized during the procedure is a well- known~     independent factor affecting the occurrence of CI-AKI.~      Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool~     during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise~     information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the~     recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of~     contrast media during PCI.~      In the present study, the hypothesize that IVUS guidance, and its consequent reduction in~     the volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison~     to standard angiography-guided intervention.~   "
23990|NCT02743143|"~     Patients with schizophrenia have disabling symptoms and cognitive deficits that limit~     motivation, drive, social- and occupational performance, quality of life and self-efficacy.~     Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory~     trials suggest that exercise improves cognitive functioning, symptoms, and quality of life,~     and reduces the risk of cardiovascular disease. However, due to this illness, the~     participation in regular exercise is challenging. In this study it will be tested if~     patients with schizophrenia can participate in long-term exercise therapy, and whether~     long-term supervised exercise therapy is more beneficial than today's usual care.~   "
23991|NCT02743130|"~     Berries have been shown to improve postprandial glucose and insulin responses to sucrose.~     During processing and storage of berry products, sucrose is inverted to glucose and~     fructose. The effects of berries on the glycemic response induced by inverted sugar are not~     known. The purpose of this study is to determine whether berries are effective in lowering~     the postprandial glucose and insulin responses induced by inverted sugar.~   "
23992|NCT02743117|"~     This prospective annual release study is designed to evaluate the safety of 1 new influenza~     virus vaccine strains to be included in FluMist Quadrivalent for the 2016-2017 influenza~     season~   "
23993|NCT02743104|"~     The purpose of this study is to determine whether ketamine or propofol, drugs used for~     procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction~     and better side effect profile.~   "
23994|NCT02743091|"~     This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary~     hypertension (PH) in patients with end-stage kidney disease (ESKD).~   "
23995|NCT02743078|"~     This phase II trial will investigate the efficacy and safety of the addition of Optune~     (Tumor Treating Fields or TTF Therapy) to bevacizumab for patients with~     bevacizumab-refractory recurrent glioblastoma.~   "
23996|NCT02743065|"~     The purpose of this multicenter registry is to gather the safety, efficacy and survival data~     in advanced HCC patients treated with HepaSphere in China in order to evaluate the~     application of HepaSphere deTACE in treating advanced HCC patients~   "
23997|NCT02743052|"~     Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of~     cancer-related stroke, particularly in those without conventional stroke etiologies.~     Randomized clinical trials have investigated efficacy of vitamin K-dependent oral~     anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent~     oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However,~     relatively little is known about the biological changes underlying intravascular~     coagulopathy and mechanisms of anticoagulation therapy in patients with cancer-related~     stroke. The aim of this study is to evaluate to determine the biological markers for~     intravascular coagulopathy causing stroke and for monitoring the effects of anticoagulation~     therapy, in patients with active cancer and stroke.~   "
23998|NCT02743039|"~     The Northwestern University Two-Generation Child and Family Outcomes Study (NU2Gen) of the~     Community Action Project of Tulsa County's (CAP Tulsa's) CareerAdvance® program examine the~     effects of CareerAdvance® on child outcomes (e.g., child academic achievement and behavior).~   "
23999|NCT02743026|"~     Indigenous youth are disproportionately represented in new HIV infection rates in Canada.~     Limited studies have evaluated longitudinal effects of arts-based approaches to HIV~     prevention with youth. The authors present a rationale and study protocol for an arts-based~     HIV and sexually transmitted infections (STI) prevention intervention with Northern and~     Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre~     non-randomised cohort pilot study using a pre-test/post-test design with a 12-month~     follow-up. The target population is Northern and Indigenous youth in eighteen communities in~     the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools.~     Participants will be involved in an arts-based intervention, Fostering Open eXpression among~     Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the~     intervention, and a 12-month follow up.~   "
24000|NCT02743013|"~     This clinical pharmacology study is performed to evaluate the total systemic exposure and~     the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in~     healthy volunteers.~   "
24001|NCT02743000|"~     The proposed study will examine the role of reward and emotion in women with and without a~     history of binge eating. It is important to understand how the brain responds to reward and~     emotion in binge eating in order to identify different pathways toward binge eating and~     provide individualized targets for treatment. This is particularly important in light of the~     fact that for many patients, the current treatments for binge eating are not effective.~   "
24005|NCT02742948|"~     Objective: To determine the optimal time for intravenous antibiotic prophylaxis~     administration in pregnant women undergoing elective cesarean section to minimize postpartum~     infectious complication for both the mother & neonate.~      Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology~     department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016~     to September 2016.~      Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living~     healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be~     randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60~     minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g)~     immediately with skin incision & group C in which 200 women will receive IV ceftriaxone (2g)~     immediately after umbilical cord clamping. Outcomes include postoperative maternal & fetal~     infectious morbidity.~   "
24006|NCT02742935|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The~     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended~     phase II doses of SHR-1210 in patients with advanced solid tumors.~   "
24007|NCT02742922|"~     To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in~     patients with a history of self-harm~   "
24008|NCT02742909|"~     To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on~     pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was~     administered as a continuous infusion for 24 hours , pulmonary artery pressure and other~     hemodynamic parameters were monitored by Swan- Ganz catheter.~   "
24009|NCT02742896|"~     Erectile and Cognitive function by using the questionnaire and assessment form before sinus~     conversion~   "
24010|NCT02742883|"~     Current therapies for diffuse, intrinsic pontine glioma (DIPG) provide very limited benefit~     to the patient. The rationale for the use of Antineoplaston therapy in this protocol study~     derives from experience with subjects from prior Phase 2 studies and Compassionate Exemption~     patients treated with Antineoplaston therapy at the Burzynski Clinic.~      This study is designed to analyze the efficacy and safety of Antineoplaston therapy in five~     separate DIPG patient cohorts, which are defined by age and prior therapy. This is a two~     stage study with 20 patients in each cohort being enrolled in the first stage and an~     additional 20 patients being enrolled in the second stage, if pre-determined efficacy~     endpoints in the first stage are realized.~   "
24011|NCT02742870|"~     Diffusion-weighted sequences have been routinely performed for years to study the pelvis.~     They have been so far mainly qualitatively interpreted, that is to say as the absence or~     presence of an hypersignal at a high b value. The quantitative analysis involves placing the~     region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual~     placement is very operator dependent, and does not reflect the entirety of the studied mass.~      In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating~     diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is~     still little studied for tumor heterogeneity analysis, including in the gynecological~     sphere.~      The investigators will therefore retrospectively evaluate the apparent diffusion coefficient~     (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic~     imaging resonance analysis of adnexal masses and confront the results with the~     anatomo-pathology results, for patients having undergone surgery, and/or with the clinical~     and imagery follow-up results.~      The investigators goal will be to improve the performance of conventional MRI in the~     analysis of adnexal masses.~      The expected benefits of this study are:~        -  a correlation with the histology analysis or the clinical monitoring~        -  an improved prediction of the malignancy of the tumor~        -  an improved magnetic resonance imaging performance for adnexal masses, with better~          surgical therapeutic management~        -  an improved negative predictive value, thereby ultimately limiting unnecessary surgical~          explorations.~   "
24012|NCT02742857|"~     This is the proof of concept study with multi-modality approach (using intra-thecal~     bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation~     as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal~     injury to document possibility of reversal of brain death (BD).~   "
24013|NCT02742844|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size~     reduction) and safety (by monitoring occurring adverse events) of the investigational~     medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.~   "
24014|NCT02742831|"~     This is a pilot randomized controlled trial of a behavioral intervention focused on~     improving parenting skills and preventing child neglect in families of children with special~     health care needs. The intervention focuses on problem solving, distress tolerance, and~     emotional regulation skills.~   "
24015|NCT02742818|"~     Prospective randomized trial comparing effectiveness of two different forced-air warming~     blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal~     aortic aneurysm repair (EVAR).~   "
24016|NCT02742805|"~     The proposed research is intended to determine if supplementation of relatively high dose~     vitamin D in chronic urticaria patients receiving omalizumab will result in continued~     symptomatic control of hives after the discontinuation of omalizumab.~   "
24017|NCT02742792|"~     The objective of the study is to evaluate the impact of strength training on sleep apneas in~     the elderly. Individuals aged between 65 and 80 years and that presenting apnea-hypopnea~     index between 20 and 50 events per hour, measured by out-of-center portable polysomnography,~     will be recruited. Those included will be randomized to two groups: Intervention: consisted~     of 12 weeks, twice a week, of strength training; or control: consisted of lifestyle~     recommendations.~   "
24018|NCT02742779|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     orally administered doses of GDC-0310 in healthy participants.~   "
24202|NCT02740374|"~     The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is~     effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood~     Products vs control cases without ROTEM assessment.~   "
25288|NCT02726191|"~     The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of~     two novel computerized cognitive enhancing software packages for improving cognitive and~     behavioral outcomes in patients with epilepsy.~   "
24019|NCT02742766|"~     This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind),~     three part study. The primary objective of the study is to characterize the safety, and~     tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28~     daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single~     and multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day,~     repeat-dose, dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose~     study in obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available~     prior to escalation decisions. Data from Parts 1 and 2 will be available prior to initiation~     of the three parallel cohorts in Part 3. A dose escalation meeting will be held to review~     these data and document the decision to proceed as planned or make any alterations in~     dosing, if indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30~     subjects, respectively.~   "
24020|NCT02742753|"~     The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on~     physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish~     children by collecting and analyzing patient level observational data already available in~     existing regional and national databases.~   "
24021|NCT02742740|"~     The Study Buddy Embodied Conversational Agent (ECA) acts as an adviser to patients~     participating in clinical trials, promoting protocol adherence and retention, providing~     anticipatory guidance and answering questions, serving as a conduit to capture information~     about complaints or adverse events, providing an avenue for communicating about updates; and~     providing guidance for those withdrawing from a protocol. The Study Buddy will use a~     web-based ECA infrastructure developed for use on another project. The investigators will~     use web browsers on Smart Phones provided to study participants to access the Study Buddy,~     providing anywhere, anytime access to its functions. Usability metrics will include session~     time, satisfaction, and error rates.~   "
24022|NCT02742727|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell~     immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.~   "
24023|NCT02742714|"~     This clinical study is designed to evaluate the PillCam SBC system performance in 50~     established or suspected inflammatory bowel disease (IBD) patients by visualizing and~     assessing their small and large bowel.~   "
24024|NCT02742701|"~     Diabetes prevalence in palliative care is 10-15%. Most hospice patients are treated with~     insulin. The target glucose level is high in order to decrease the risk of hypoglycemia.~     Glucose level is usually monitored using capillary blood glucose once to three times daily.~      The aim of the research is to simplify this pattern of care in end-of-life patients. It will~     evaluate whether the non invasive measurement of glucose in urine could replace the~     measurement of capillary blood glucose. The first objective will be to assess the~     performance of the measurement of glucosuria using urinary dip stix to predict that the~     blood glucose level is within the target range.~      Due to the high glucose target, hyperglycemia is extremely frequent. However, symptoms of~     hyperglycemia are unfrequently reported. They may be unspecific and/or masked in end-of-life~     patients due to terminal disease and medication. The second objective of the study will be~     to define symptoms of hyperglycemia in these patients.~   "
24025|NCT02742688|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel~     extract on decrement of body fat. The investigators measured decrement of body fat~     parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and~     monitored their blood pressure.~   "
24026|NCT02742675|"~     The goal of this clinical research is to learn if treatment with androgen deprivation~     therapy in combination with surgery or radiation therapy can prolong the progression-free~     survival of oligometastatic prostate cancer than androgen deprivation therapy alone. The~     safety of this treatment combination will also be studied.~   "
24027|NCT02742662|"~     The study will evaluate whether a technology-based lifestyle intervention program using~     primarily a smartphone platform is an acceptable and effective way for treating obesity. The~     goal of the program is to achieve weight loss and enhance the health of overweight or obese~     subjects by improving their diet and activity via smartphone applications as compared with~     conventional in-person weight management programs.~   "
24028|NCT02742649|"~     The purpose of this study is to determine if a combination of two drugs (bimatoprost and~     timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular~     pressure (IOP) than either of the drugs delivered alone.~   "
24029|NCT02742636|"~     Objective: The aim of this study is to evaluate if direct removal of the urine catheter~     after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic~     supracervical hysterectomy) is associated with similar (or better) outcomes compared to~     delayed catheter removal after surgery, which is the current treatment. In addition, we want~     to investigate patient's experience on this subject.~      Study design: Randomized Controlled trial, non-inferiority study.~      Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for~     benign indication or low-grade malignancy.~      Intervention:~        -  Group A (treatment group): the patients in this group will have their catheter directly~          removed in the OR after LH.~        -  Group B (control group): the patients in the control group will have their catheter~          removed according to the regular protocol of the hospital (at least 6 hours in place).~   "
24030|NCT02742623|"~     This study aims to collect patient reported outcomes and assess treatment satisfaction in~     active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).~   "
24031|NCT02742610|"~     This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management~     (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving~     outpatient psychiatric treatment. This project is expected to result in the development of~     an effective intervention that will produce preliminary data showing increased short-term~     cessation success in depressed smokers receiving outpatient psychiatric treatment. It is~     anticipated that this smoking cessation intervention will have potential for broad reach to~     outpatient psychiatric treatment programs and have a significant overall impact in reducing~     smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk~     populations.~   "
33990|NCT02612168|"~     Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to~     detect melanoma in pigmented lesions, compared to gold standard histological determination.~   "
24032|NCT02742597|"~     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is~     to reorient the health care system from a single disease focus to a multimorbidity focus;~     centre on not only disease but also the patient in context; and realign the health care~     system from separate silos to coordinated collaborations in care. PACE in MM will propose~     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be~     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),~     that are linked to Primary Care (PC) reform efforts. The study will build on this firm~     foundation, will design and test promising innovations and will achieve transformation by~     creating structures to sustain relationships among researchers, decision-makers,~     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is~     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces:~     British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's~     objectives are: 1) to identify factors responsible for success or failure of current CDPM~     programs linked to the PC reform, by conducting a realist synthesis of their quantitative~     and qualitative evaluations; 2) to transform consenting CDPM programs identified in~     Objective 1, by aligning them to promising interventions on patient-centred care for~     multimorbidity patients, and to test these new innovations' in at least two jurisdictions~     and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by~     Objective 1 and tested/proven in Objective 2, and to conduct research on different~     approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2~     of the study.~   "
24033|NCT02742584|"~     This is a multicenter, prospective, randomized comparative study in which patients are~     randomized to one of four different bladder volumes and a Cough Stress Test (CST) is~     performed in both the standing and sitting positions. The goal is to assess the agreement of~     each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the~     24-hour pad test. The primary outcome is to determine what CST method best correlated with~     either test in the diagnosis of SUI.~   "
24034|NCT02742571|"~     Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic~     Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality,~     morbidity and nutrition in ICU~   "
24035|NCT02742558|"~     To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM,~     Investigators will conduct a clinical trial study Bangladeshi healthy adults and children.~     Cholvax is locally produced orally administered whole cell inactivated bivalent cholera~     vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now~     producing the oral cholera vaccine, Cholvax with technological support from International~     Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP)~     standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in~     terms of strains and formulation. By this transfer of technology, it expected that the~     vaccine will become available for use in public health programs in Bangladesh and in the~     future in other cholera-affected countries in Asia and Africa to control endemic cholera, as~     well as to help control large-scale epidemics and outbreaks.~      Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots~     (lot-to-lot consistency).~   "
24036|NCT02742545|"~     This study evaluates the efficacy of MayoExpertAdvisor (MEA), a knowledge delivery tool, to~     improve adherence to best practices for patients with hyperlipidemia, atrial fibrillation~     and heart failure. Half of the clinicians will receive MEA, while the other half will not~     receive MEA.~      The investigators hypothesize care teams with access to MEA will act upon recommendations at~     a higher rate than those care teams in the standard of care arm without access to MEA.~   "
24037|NCT02742532|"~     The purpose of this study is to determine whether oxytocin will decrease craving to use~     alcohol and stress reactivity following exposure to laboratory-induced stress among Active~     Duty Service Members with a dual diagnosis of alcohol use disorder and post-traumatic~     anxiety.~   "
24038|NCT02742519|"~     To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI),~     in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance~     regulator (CFTR) gating mutation~   "
24039|NCT02742506|"~     Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged~     patients. However, it is still difficult to understand what precisely in music causes a~     positive effect : are they emotional components, familiarity or preference which improve~     cognition or is there any specific effect of music? Moreover, it is not yet possible to~     characterize the neural and functional links between the brain systems solicited by music~     and those associated with other cognitive functions enhanced by music.~      Finally, researches on brain-damaged patients have not exploited the potential effect of~     music on the level of alert and perceptual awareness, while this type of stimulation could~     be a valuable tool to improve cognition in patients with a disturbance of consciousness and~     alertness.~      The main objective is to describe the impact of music on the brain's response to~     self-referential or neutral stimuli in brain-damaged patients with persistent consciousness~     disorder after a coma and in healthy participants.~   "
24040|NCT02742493|"~     The present study aims to assess the effectiveness of three different retention schemes used~     to maintain tooth position after orthodontic treatment with fixed orthodontic appliances~     (stability) and to evaluate possible association between retention scheme and gingival~     recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years~     post-treatment. Moreover the possible association between primary relapse tendency and long~     term occlusal stability will be evaluated.~   "
24041|NCT02742480|"~     SEDMAN study is a prospective multicenter investigator initiated study (IIS). The main idea~     is to look by Genome Wide Association (arrays that determine more than 1 million~     polymorphisms) genetic risk factors associated with response to dabigatran. To conduct the~     study, the goal is to recruit 300 patients with ischemic stroke with cardioembolic etiology~     treated with dabigatran and 200 treated with Acenocoumarol to determine if genetic risk~     factors are associated with the occurrence of any bleeding or vascular event in a year~     follow-up.~   "
24042|NCT02742467|"~     The creole study is a A Multi-centre, multinational, randomised single-blind, parallel~     group, three-armed superiority trial which is aimed at comparing the efficacy of three~     free combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood~     pressure (ASBP) in black African hypertensive patients.~   "
24045|NCT02742428|"~     Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex,~     cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of~     hypo- or hypervolemia in a perioperative period. All these factors may cause hemodynamic~     consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality.~      The objective of the study is to evaluate, whether slow ascites evacuation for a few days~     before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on~     systemic circulation in patients undergoing surgery, 2) improve patient's quality of life~     and 3) ability to feed correctly before treatment starts, and thus lower the risk of~     perioperative morbidity.~      Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who~     are scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation~     before neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for~     any reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical~     data, a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to~     either intervention arm A - insertion of vascular catheter into abdominal cavity and slow,~     systematic, daily ascites evacuation, or to observation arm B - standard of care with just~     observation (acute large volume (>5000ml) paracentesis allowed if needed). Patients in both~     groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1,~     for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to~     fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During~     the first hour of the surgery hemodynamic data from anethetic charts will be recorded along~     with other clinical data concerning patient's characteristics, surgery details and 30-day~     postoperative follow-up. A template is provided.~      The hypothesis of the study is that slow, systematic ascites evacuation few days before~     surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic~     circulation of patients undergoing surgery, and improve patients' quality of life, feeding~     ability before treatment starts. Secondary we would expect lower risk of perioperative~     morbidity and mortality.~   "
24046|NCT02742415|"~     Since there is a limited amount of evidence on the feasibility and outcomes on the use of~     hand massage in patients undergoing cancer treatment, the purpose of this study is to~     evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing~     chemotherapy, and to measure its influence on their symptoms.~   "
24047|NCT02742402|"~     The aim of the study is to evaluate whether patients with early equivocal appendicitis can~     be observed instead of immediate diagnostic imaging. Half of the patients are randomly~     assigned to observation group, while the other half will undergo diagnostic imaging. The~     hypothesis is that resolving appendicitis is common in these patients. Thus, in observation~     group there will be fewer patients with appendicitis diagnosis and observation reduces the~     use of diagnostic imaging and surgery.~   "
24048|NCT02742389|"~     The purpose of this study is to determine whether an intervention (pre-procedure telephone~     call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT)~     compared to usual care. Our hypothesis is that women who receive the intervention will~     report less anxiety immediately before UDT than women who receive usual care.~   "
24049|NCT02742376|"~     This study compares the gait pattern of individuals with weight bearing difficulties walking~     on the floor, a soft surface, or with special shoes (Kyboot).~   "
24050|NCT02742363|"~     The investigators aim is to explore associations between specific types of cancer therapy,~     age at treatment and the presence of dental abnormalities in adolescence.~      The study will help identify unique dental changes, malformations and or missing teeth that~     appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy~     and or radiotherapy) given in childhood.~      Materials and methods:~        -  Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the~          age of 0-10 years old.~        -  The following data will be collected: Demographic information, Medical Status, Cancer~          therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic~          examination.~   "
24051|NCT02742350|"~     Heart surgery procedures are still widely used worldwide for the treatment of patients with~     heart problems, and rates of complications in the postoperative period related to them~     remain high. In these patients, physical conditioning programs result in improved functional~     capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle~     training is also emerging as a valuable strategy in the treatment of cardiac patients. The~     study of the interaction between cardiac rehabilitation and high intensity IMT about these~     changes is not yet understood in this population. The aim of this study is to assess the~     effects of inspiratory muscle training high intensity associated with cardiac rehabilitation~     exercise performance of patients in the postoperative period of CABG surgery.~   "
24052|NCT02742337|"~     • Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs~     (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify~     genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis~     patients have been inconclusive. Furthermore the presence of epigenetic signatures in~     rheumatoid arthritis patients has not been established. This protocol is the first step to~     identifying the practicality and feasibility of epigenetic testing to aid in diagnosis~     and/or medication selection in rheumatoid arthritis patients. Subsequent research into such~     epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic~     signatures (EGS) exist the business need for such tests will thus be supported.~   "
24053|NCT02742324|"~     Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose~     combination that also satisfies certain safety requirements. It consists in a dose finding~     study to assess the safety of the combination of different doses of both ruxolitinib and~     peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the~     first part of the study to a total maximal number of 42 evaluable patients.~   "
24054|NCT02742311|"~     In this prospective observational trial the effect of the Endoscopic discectomy~     microinvasive therapy should be examined in (approximately 500) adult patients with low back~     pain.~   "
24055|NCT02742298|"~     Study Objectives:~        1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical~          impedance myography (EIM) and currently accepted measures of physical function.~        2. Determine the reliability of EIM measures performed in the home through use of a hand~          held device.~        3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.~   "
24078|NCT02741999|"~     This protocol seeks to enroll smoldering multiple myeloma (SMM) patients with λ light chain~     (LC) involvement, a group of patients for whom standard of care is observation not~     treatment. Patients with SMM have a precursor plasma cell disorder from which light chain~     amyloidosis (AL) often evolves. In this trial they will have blood and bone marrow cells~     evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline~     gene. The repertoire of clonal germline genes employed in AL is restricted; 70% of cases of~     AL involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that~     will be tested with this protocol is that the presence of VL germline genes associated with~     AL in patients with a pre-existing diagnosis of λ SMM will be indicative of risk of~     progression to AL.~   "
24056|NCT02742285|"~     Measurement of the concentration of antimalarials in the blood of the general population~     helps estimating the overall drug pressure and is used in efficacy studies. The current~     sampling standard for drug measurement is plasma obtained by venous puncture. The use of a~     Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions~     easier, but concordance with usual venous sampling is not yet established.~      The current work will allow validating the concentrations of lumefantrine measured in the~     DBS samples collected during the field trials and validate the use of DBS for future~     studies. In addition, bearing in mind the substantial deployment of artemether-lumefantrine~     combinations supplies throughout most malaria endemic countries, this study may improve our~     understanding of lumefantrine and artemether distribution in the blood compartments and~     generate knowledge for further developing analytical methods for drug measurement.~      The overall purpose of this study is to validate the dried blood spots as a sampling method~     for the analysis of lumefantrine.~      The primary objective is to assess the concordance between lumefantrine plasma and dried~     blood spots (DBS) concentrations.~      The investigators also aim at describing lumefantrine's distribution in the different blood~     compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total~     in whole blood.~   "
24057|NCT02742272|"~     The purpose of this study is to develop a clinical decision rule for patients seen in the~     pediatric emergency department for possible intracranial pathology. This a prospective study~     evaluating patients presenting with headache and migraine. The study is observational and~     does not impact patient care.~   "
24058|NCT02742259|"~     The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC)~     analysis system will be validated in patients diagnosed with metastatic prostate cancer. It~     will demonstrate substantial performance equivalency to a CTC Assay predicate device.~   "
24059|NCT02742246|"~     Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment~     for reducing alcohol use~   "
24060|NCT02742233|"~     To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients~     with diabetic foot ulcers, the investigators randomly divided the participants into two~     groups: saxagliptin with regular treatment group，placebo with regular treatment group. The~     clinical data are collected at the given time point. This study aimed to observe the~     potential protective effect of DPP4i on diabetic ulcers.~   "
24061|NCT02742220|"~     The aim of this study is to analyze the effects of isometric handgrip training (IHT) on~     blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited~     60 patients which will be randomized into 2 groups (30 per group), IHT and control group~     (CG). IHT group will training isometric contraction for 8 weeks. The GC patients will be~     encouraged to increase the level of physical activity. In the pre and post-intervention,~     brachial and central blood pressure will be measured.~   "
24062|NCT02742207|"~     Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many~     patients in order to regain sinus rhythm. In a previous retrospective study a complication~     of acute renal failure was found in 17% of the patients after cardioversion.(The incidence~     and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman~     Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described~     after cardioversion is pulmonary edema.~      In this prospective study the investigators aim to evaluate the risk of acute renal failure~     post cardioversion. In addition the investigators would like to evaluate hemodynamic~     changes, fluid balance and sodium levels in patients post cardioversion as a potential~     mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to~     assess hemodynamic changes the investigators will use a non-invasive FDA approved device~     called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac~     index and peripheral vascular resistance in a non-invasive, fast and accurate way.~   "
24063|NCT02742194|"~     Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies~     are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic~     and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the~     treatment for obesity. The primary objective of the current study is to assess whether~     consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat~     body percentage, increase basal metabolic rate and improve loss weight.~      The secondary objectives are:~        -  to assess the effect of nutritional intervention in quality of diet and weight loss.~        -  to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in~          overweight subjects.~   "
24064|NCT02742181|"~     This will be a prospective randomized control trial with a total of 142 patients. Patients~     who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy~     reversal with small bowel resection that subsequently develop postoperative ileus will be~     eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized~     at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to~     receive conservative standard care.~      Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from~     the time of randomization until the return of bowel function or 5 days. Both groups will be~     treated with conservative standard care, including bowel rest, reduction in oral diet, and~     placement of nasogastric tube as clinically indicated.~      All patients will follow a standard ERAS pathway after surgery, with early feeding and~     ambulation, along with opioid minimizing measures as is our standard postoperative protocol.~      Primary outcome will be hospital length of stay. Secondary outcomes will include time to~     return of bowel function, 30-day morbidity/mortality, complications, reoperation and~     readmission.~      Total number of patients: 142 Patients in each study group: 71~   "
24079|NCT02741986|"~     Brief Summary: The goal of this study is to implement and test an intelligent perioperative~     system (IPS) that in real-time predicts risk for postoperative complications using routine~     clinical data collected in electronic health records. The accuracy of computer-generated~     risk scores will be compared to physician's risk scores for the same patients. Physicians~     will be also asked to provide the opinion regarding the computer-generated risk scores using~     interactive interface with the program. The information regarding the risk scores~     performance will be collected during the two 6-month periods. The accuracy of IPS and~     physicians will be compared at the end at those two time periods.~   "
24065|NCT02742168|"~     This is an open-label SPECT/CT (single photon emission computed tomography / computed~     tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and~     efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast~     cancer. The standard of truth for diagnosis was based on histopathologic findings after~     surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A~     single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20~     µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative~     method will be used to assess the whole-body planar and lesions SPECT/CT images.~      Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast~     cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.~     The standard of truth for diagnosis was based on histopathologic findings after fine needle~     aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg~     3PRGD2) will be intravenously injected into the patients before treatment, the second~     period, sixth period. Visual,semiquantitative method will be used to assess the whole-body~     planar and lesions SPECT/CT images. By comparing with result of the other related imaging,~     for instance, PET/CT (positron emission tomography/computed tomography), CT (computed~     tomography), MRI (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.~   "
24066|NCT02742155|"~     The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on~     families of infants with infant sleep disturbances.~   "
24067|NCT02742142|"~     This study was a randomized clinical trial lasting for 24 months in two study sites, Hong~     Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will~     be recruited from elderly social centers located in different districts in the two study~     sites (260 & 274). Baseline clinical examination was conducted by a single calibrated~     examiner in the social centers using an intra-oral LED light, mouth mirrors and probes.~     Subjects were randomly allocated into two study groups and receive interventions~     accordingly. Follow-up examinations at 6-month intervals were carried out to assess the~     clinical outcomes, i.e. whether new root caries developed and whether the active root caries~     found at baseline become arrested. Results of this study could provide the much needed~     evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in~     deciding on the most appropriate intervention for the prevention and management of this~     common dental disease of the older adults.~   "
24068|NCT02742129|"~     A randomized, double-blind, placebo-controlled crossover study to assess the effect of~     inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing.~     Approximately 100 participants will be enrolled in this 2*2 crossover study.~   "
24069|NCT02742116|"~     The objectives are to:~        1. Assess patient's views and preferences in receiving expanded carrier screening~        2. Perform qualitative study on post testing counselling on screen positive individuals~          and at risk couples~   "
24070|NCT02742103|"~     This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,~     parallel-group study to investigate the renal safety and tolerability of multiple dose~     intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate~     renal impairment (RI) and acute myocardial infarction (AMI).~   "
24071|NCT02742090|"~     This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a~     single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK~     inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)~   "
24072|NCT02742077|"~     The purpose of this study is to evaluate the safety and performance of the CorPath 200~     System in the remote delivery and manipulation of guidewires and rapid exchange catheters~     for use in percutaneous vascular interventions.~   "
24073|NCT02742064|"~     The purpose of this study is to determine if a mobile sensing platform can passively and~     objectively detect the presence of clinically significant mood disorder symptomatology and~     symptom progression over time. Meeting this goal will allow for improved risk~     categorization, prediction of relapse, and measurement of disease progression in a lifetime~     prevalence population.~   "
24074|NCT02742051|"~     This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of~     neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus~     cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative~     breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast~     cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by~     imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18~     weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine~     the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with~     ER-positive, HER2-negative breast cancer, and to compare the response rate by clinical~     palpation. Secondary aims are to compare the ultrasound response rate, pathological complete~     response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the~     percentages of peripheral blood CD8+ T cells, T helper cells (Th), regulatory T cells~     (Treg), and NK cells (pre- versus post- neoadjuvant therapy).~   "
24075|NCT02742038|"~     Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and~     2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic~     areas of Chile were invited to participate. Oral health education component was given to~     children, parents and educators, twice yearly. A new toothbrush and toothpaste for each~     child was delivered to the parents at baseline and in each of the follow-up visits. The~     experimental group was treated with fluoride varnish every six months while the control~     group received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of~     Caries Incident Cases, increment dmft index~   "
24076|NCT02742025|"~     The main objective of this study is to evaluate the impact on preoperative anxiety of an~     education and information program conducted prior to non-urgent coronary angiography~     performed in patients hospitalized at the Nîmes University Hospital.~   "
24077|NCT02742012|"~     The present study is designed to validate an multimodal indicator of anesthetic depth~     (Schneider G et al. 2014, Anesthesiology 120, 819-28).~      The indicator previously developed shall now be tested on an independent set of data.~      The investigators will include 250 patients undergoing general anesthesia in 3 German~     tertiary care centers.~      The design is strictly observational - the anesthetic regime is at the discretion of the~     clinician and will not be influenced.~   "
24082|NCT02741947|"~     The trial was an experimental two-centers, randomized, double-blind, two-sequence,~     non-inferiority cross-over study.~      Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to~     participate in the study entered a 4 weeks period if not on stable regimen of Madopar®~     (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks~     each, for a total duration of 8 weeks.~      Patients were assigned randomly (1:1) by a computerized randomization system to one of two~     formulation sequences maintaining the dose stabilized during the run in:~        -  generic-originator~        -  originator-generic At the end of maintenance period 1, the patients in each formulation~          group underwent an overnight switch to the same dose of the alternative formulation.~          The dose was kept stable during the whole length of trial. Clinical evaluations were~          performed at the end of each period. The tablets were encapsulated to maintain the~          blindness.~      A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of~     14 subjects.~      Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5~     years, receiving L-dopa/benserazide.~      The total duration of the trial was approximately 8 weeks for patient divided in two~     maintenance periods of 4 weeks each.~   "
24083|NCT02741934|"~     This study evaluates the cognitive and behavioral outcomes including image findings of~     school-aged children who were born preterm compared with who were born term gestational age.~   "
24084|NCT02741921|"~     The investigators sought to compare the time to intubation and success rate of the~     endotracheal intubation using standard double-lumen tube and video tube ETView DL in an~     adult cadaver model in normal and difficult airway conditions.~   "
24085|NCT02741908|"~     Obesity is a chronic illness and multifactorial etiology, related to genetic factors,~     environmental and behavioral. Features association with several metabolic abnormalities in~     childhood, leading to increased risk of cardiovascular disease in adult life. The treatment~     involves lifestyle change, with balanced diet guidance and encouraging physical activity.~     The treatment in this age group have brought limited data, in addition to high drop-out~     rates. A unique type of food guidance is the equivalent calorie count, where calories are~     converted into points. The objective of this study was to evaluate the variance of Z score~     of body mass index (ZIMC) of obese adolescents undergoing orientation of two groups of~     low-calorie diet: traditional and based on the points system, as well as evaluate~     anthropometric variables, body composition, food intake, metabolic changes and~     self-monitoring.~      METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an~     average age of 13.7 ± 0.7 years of both genders, with scores of BMI >= 2 to <= 4 curve~     adjusted for gender and age of the World Health Organization. Were verified weight, height,~     blood pressure and waist circumference, intensity of physical activity and self- monitoring,~     as well as performed the nutritional guidance to each visit. Laboratory parameters, applying~     the scale of binge eating, pubertal, stage and body composition were evaluated at the~     beginning and end of the action. The patients were divided into two groups: one that~     received guidance of traditional low-calorie diet and meet the food consumption record~     (RCA), three days (Group A) and another that received low-calorie diet guidance based on the~     system of points and meet the daily RCA (Group B).~   "
24086|NCT02741895|"~     This study will evaluate whether information on postoperative ambulation from Fitbits can~     improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged~     length of stay, 30-day readmissions, and discharge to transitional care after major surgery.~   "
24087|NCT02741882|"~     It is suspected that zika virus infection during pregnancy is associated with microcephaly.~     The objective of this study is to investigate the occurrence of rash accompanied by three or~     more dengue-like signs and symptoms during pregnancy is related to the microcephaly using~     the case-control design.~   "
24088|NCT02741869|"~     The purpose of the study is to evaluate whether PDT (MRSAid™) is effective in eradicating SA~     from hemodialysis patients who are known to harbor this organism inside their nose.~   "
24089|NCT02741856|"~     Research has shown that increasing the dose of radiotherapy improves outcomes in patients~     with lung and head and neck cancers. This study aims to see whether this is also the case~     for patients with tumour of the oesophagus. This trial will compare the effects of the~     standard dose of radiotherapy to a higher dose whilst closely monitoring the side effects.~      A comparison will also be made regarding the effects of the standard drugs used in~     chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and~     paclitaxel) in patients that do not show a response to chemotherapy with standard drugs~     early on in treatment.~      All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.~      How the study will be conducted:~      Prior to the commencement of treatment each patient will have a special scan called a PET~     scan. Patients will receive a second PET scan two weeks after the start of standard~     chemotherapy. The changes between the two scans will then be used to allocate treatment into~     the different arms of the study. All study subjects will be randomised to receive either the~     standard radiotherapy dose or the high radiotherapy dose. The participants that do not~     respond to the first cycle of standard chemotherapy will be eligible to take part in the~     aspect of the trial looking at an alternative chemotherapy regimen. Patients will be~     randomised as follows;~      On the basis of the second PET scan, patients who are not responding to standard~     chemotherapy will be allocated by a computer to one of the four groups detailed below:~        -  Standard chemotherapy and standard dose of radiotherapy~        -  Standard chemotherapy and higher dose of radiotherapy~        -  Alternative chemotherapy and standard dose of radiotherapy~        -  Alternative chemotherapy and higher dose of radiotherapy~      Patients who are responding to standard chemotherapy (or where the response is unknown or~     those who were not eligible for PET scan portion of the study) will be allocated by a~     computer to one of two groups detailed below:~        -  Standard chemotherapy and standard dose of radiotherapy~        -  Standard chemotherapy and higher dose of radiotherapy~      The arms within each of the groups above (responders and non-responders) will be equal in~     size and patients will be allocated randomly by a computer.~      This study will also compare the way that this treatment affects the two different cell~     types found in oesophageal tumours.~      The effects of the different treatment, together with the costs of the different treatment~     and the effects on quality of life will be analysed to see which is more effective for each~     of the different groups.~   "
24090|NCT02741089|"~     This monocentric, non-interventional observational registry study was designed in order to~     obtain data of patients with the indication for a flexible bronchoscopy to control and~     optimize a guideline conform therapy of these patients.~   "
24091|NCT02741076|"~     The purpose of this study is to evaluate the effect on pain intensity (PI) of structured~     discontinuation of long-term opioid analgesic therapy compared to continuation of opioid~     therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic~     therapy for chronic low back pain (CLBP).~   "
24092|NCT02741063|"~     to investigate whether oxytocin alter attentional bias towards emotional expression faces in~     individuals with high and low autistic traits, and the brain mechanism of this effect~   "
24093|NCT02741050|"~     The goal of this proposal is to test the efficacy of a primary care-delivered, print-based~     physical activity intervention for Latinas with type II diabetes. The investigators will~     test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes~     recruited through UCSD Health System primary care to either the adapted web-based physical~     activity intervention or standard of care, and assessing physical activity gains at six and~     12 months. The ultimate goal is to develop a print-based physical activity intervention for~     diabetic Latinas that could be widely disseminated through primary care.~   "
24095|NCT02741024|"~     This will be an open-randomised non-inferiority study to test the hypothesis that the risk~     of recurrent parasitaemia after 42 days is not worse in the group receiving the~     Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the~     Artemether-Lumefantrine (Coartem®) regimen. Children with uncomplicated malaria meeting the~     inclusion criteria will be enrolled (after their parent/caretaker has given informed~     consent), treated on site with the drugs under evaluation and followed-up for a period of 42~     days. Drugs will be given under direct supervision, either at the clinic or at home.~     Follow-up shall consist of a fixed schedule of clinical and laboratory examinations. Based~     on clinical and laboratory findings, children will be classified as therapeutic failures~     (early or late) or adequate responders.~      The proportion of cases experiencing an in vivo therapeutic failure during the follow-up~     period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain~     Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to~     treatment failure from episodes of re-infection. This proposal is compliant with the latest~     WHO recommendations for anti-malarial efficacy monitoring in high, medium or low~     transmission zones11.~   "
24096|NCT02741011|"~     Aim of this study is to evaluate the necessity of the radiological examinations of mentally~     handicapped or uncooperative patients.~   "
24097|NCT02740998|"~     Despite many years of research, controversy persists as to whether hormonal contraception~     promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone~     acetate (DMPA) injection showed an increase in HIV risk and no evidence of increased risk~     with oral contraceptive pills. There are no human studies currently published on the impact~     of the levonorgestrel intrauterine device (LNG IUD) on HIV transmission risk and minimal~     data on the effects of the etonogestrel subdermal implant (ESI) on risk of HIV acquisition.~     Establishing whether any of these highly effective contraceptives increases the risk of HIV~     infection would have far-reaching public health implications, particularly in areas of high~     HIV prevalence such as sub-Saharan Africa, where injectable contraception accounts for~     nearly half of contraceptive use.~      Perturbations in the normal vaginal microbiota, or community of microorganisms inhabiting~     the vaginal body niche, have long been known to affect the risk of transmission of HIV.~     Studies have shown altered vaginal microbiota with DMPA injection and preserved vaginal~     microbiota with the LNG IUD, but no studies have compared these methods head-to-head or used~     culture-independent sequencing methodology. The investigators propose a prospective pilot~     study to evaluate the impact of different long-acting progestin contraceptive formulations~     on the vaginal microbiome. Specifically, the investigators aim to identify and compare~     metagenomics profiles associated with DMPA, LNG IUD, and ESI contraceptive use by community~     analysis of vaginal swab samples from women collected longitudinally after contraceptive~     method initiation. The investigators hypothesize that DMPA will increase community diversity~     in the vaginal microbiota, whereas the LNG IUD and ESI will not affect the balance of~     microorganisms in the vagina. Women who are planning to initiate DMPA, LNG IUD, and ESI~     contraception as well as controls not seeking contraception will be recruited for the study~     from Boston Medical Center (BMC), a tertiary care center with a racially and~     socioeconomically diverse patient population. Women will have longitudinal follow-up with~     self-sampling of the vagina for sexually transmitted infection testing and metagenomics~     analysis at method initiation, 2-3 months, and 6 months. Establishing the safest long-acting~     progestin contraceptive alternative will promote effective contraception use and lower rates~     of HIV acquisition worldwide.~   "
24098|NCT02740985|"~     This is a Phase I, open-label, multicenter study of continuous oral dosing of AZD4635~     administered as a single agent and then in combination with a PD-L1 antibody, durvalumab.~     The study design allows an escalation of dose with intensive safety monitoring to ensure the~     safety of the patients. The primary objective of the study is to determine the maximum~     tolerated dose of AZD4635 in combination with durvalumab.~   "
24099|NCT02740972|"~     The main objective of this study is to evaluate the safety of a high (80mg/kg) and low~     (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with~     Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives~     include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.~   "
24100|NCT02740959|"~     This study is for an add-on study to the main study (Protocol No.: PH-CP012). The~     information of patients from main study will be collected by questionnaire survey and~     actigraphy measurement to evaluate the relationship between fatigue, depression and sleep~     disorder and the efficacy of PG2 after treatment.The association between symptom cluster and~     circadian rhythm will be also further explored.~   "
24101|NCT02740946|"~     This study aims to evaluate the effect of 5 months of exercise therapy for patients with~     irreparable rotator cuff tears.~   "
24102|NCT02741843|"~     The purpose of this study is to test the effectiveness of brief face-to-face patient~     education in increasing uptake of influenza vaccine among Chinese elderly in the community.~   "
24103|NCT02741830|"~     This cross sectional, two cohort study seeks to investigate both anatomic outcome and~     subjective, functional outcome of uterosacral ligament suspension versus robotic~     sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and~     complication rate for each procedure.This study will provide a better understanding about~     the durability of these procedures and long term complication.~   "
24104|NCT02741817|"~     The study is going to compare two different doses of aspirin for the treatment of heart~     disease in combination with the anticlotting medication ticagrelor. One of these doses of~     aspirin, 75 milligrams (mg) once a day, is the current standard treatment dose of aspirin~     used to treat heart attacks and angina. The other, 20 mg twice a day, is lower than the~     standard but there is growing scientific evidence that, when given with ticagrelor, this~     might offer advantages over the usual dose.~   "
24105|NCT02741804|"~     The purpose of the Lifestyle Intervention Study is to investigate the influence of a~     micronutrient supplement in combination with a comprehensive lifestyle intervention program~     on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be~     placed on supplement or placebo throughout their 18-month study participation. Patients will~     also be given lifestyle training on nutrition, physical activity, cognitive and social~     activity, meditation and sleep, which have all been proven to positively affect cognition~     over time. Throughout their participation, patients' cognitive functioning will be monitored~     with comprehensive imaging, neuropsychological testing, blood testing and study compliance.~   "
24106|NCT02741791|"~     To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with~     treatment resistant major depressive disorder (MDD).~      This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting~     of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial~     is being conducted in subjects with treatment resistant MDD.~      Subjects will be considered to have treatment resistant MDD if they have had a historical~     inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate~     response to treatment with bupropion during the open-label, lead-in period.~   "
25303|NCT02725983|"~     Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal~     therapy (SPT), on the psychological, behavioral and clinical parameters of patients with~     gingivitis, outlined by evidence and a theory-based framework.~   "
24107|NCT02741778|"~     Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of~     the esophagus and stomach. Due to the special anatomical location, the biological behavior~     of esophageal cancer and gastric cancer are not the same. For the resection of esophageal~     gastric junction adenocarcinoma, the main treatment method for the treatment of surgical~     treatment.~      For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the~     traditional surgical approach for the left chest to open the chest, for the lesions of the~     small type of esophageal gastric junction adenocarcinoma can be performed minimally invasive~     Ivor-Lewis esophageal resection.~      There is no reasonable standard for treatment of type II type esophageal gastric junction~     adenocarcinoma. The investigators sum up the experience of the past in the minimally~     invasive resection of esophageal cancer, and combine domestic and foreign research results.~     Pioneered by laparoscopic mobilization of the stomach and dissection of the abdominal field~     lymph node + thoracoscopic (left thoracic approach) to free the esophagus and cleaning +~     mirror under the purse string forceps esophagogastric aortic arch anastomosis under lower~     mediastinal lymph node, corresponding to the operation is the traditional through left~     thoracotomy combined with open operation on diaphragm. Can achieve the same with the~     traditional surgical resection of the tumor, while taking into account the characteristics~     of minimally invasive surgery. This study intends to provide a minimally invasive surgical~     treatment of the chest laparoscopy combined with minimally invasive surgery and traditional~     thoracotomy. Comparison of different surgical methods for patients with the safety of~     surgery, oncology resection range, the incidence of short-term complications. The effect of~     different surgical methods on the survival rate and quality of life of the two groups were~     compared with the postoperative follow-up. The surgical treatment of esophageal carcinoma~     with a reasonable level of type II type of esophageal gastric junction adenocarcinoma is~     improved, and the surgical treatment of esophageal gastric junction adenocarcinoma is~     improved.~   "
24108|NCT02741765|"~     This is a feasibility and exploratory study consisting of two parts: first, a~     cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived~     neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in~     patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age.~     Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation~     (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This~     exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.~   "
24109|NCT02741752|"~     The purpose of this randomized clinical trial was to evaluate the effect of cortical bone~     decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.~   "
24110|NCT02741739|"~     Primary Objective: Determine blood concentrations of two formulations of REGN1033.~      Secondary Objective: Assess safety and tolerability of REGN1033.~   "
24111|NCT02741726|"~     The purpose of this study is to compare the effects of dual acupoints and single acupoint~     transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of~     Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.~   "
24112|NCT02741713|"~     The standard practice for arthroscopic shoulder surgery at our institution is a general~     anesthetic with a long-acting interscalene block for post-operative pain control, which can~     reduce the amount of opiates needed after surgery. The interscalene block is effective in~     providing analgesia to the majority of the shoulder joint and has been shown to reduce~     post-operative pain scores after arthroscopic shoulder surgeries. However, there is a subset~     of arthroscopic shoulder surgery patients who have pain in the axilla even in the setting of~     a functioning interscalene brachial plexus nerve block. One of our surgeons has reported a~     high incidence of axillary pain in patients who undergo a sub-pectoral biceps tenodesis as~     part of their arthroscopic procedure. A newly described nerve block approach to the nerves~     that supply sensation to the axillary region called the PECS Pectoralis 1 & 2 block may~     provide additional analgesia to these patients.~      The purpose of this prospective, randomized, observer and patient blinded, single-center,~     sham block trial is to determine if the addition of PECS blocks to an interscalene block~     will reduce the severity of axillary pain following arthroscopic shoulder surgery that~     involves a sub-pectoral biceps tenodesis. Secondarily, the study will assess the duration of~     PECS 1 & 2 and whether the block reduces post-operative opioid usage. We hypothesize that~     the addition of the PECS 1 & 2 block will reduce the severity of axillary pain at 6hrs and~     reduce postoperative narcotic usage for the first 24 hours.~   "
24113|NCT02741700|"~     The objective is to test the efficacy of a patient-centered, culturally relevant narrative~     intervention, or storytelling, based on the solid conceptual foundation of the narrative~     communication theory and the constructs of the Health Belief Model (HBM) to improve~     medication adherence and outcomes in chronic diseases among African-Americans (AA), using~     gout as an example. Gout is a chronic disease associated with chronic symptoms and~     disability interrupted by intermittent acute flares, similar to Chronic Obstructive~     Pulmonary Disease (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction~     if not treated appropriately. Due to the intermittently symptomatic nature of chronic~     conditions, patients often don't perceive disease severity and susceptibility to disease~     complications, and, therefore, may not balance the barriers and benefits to medication~     adherence. Storytelling in the patients' own voices has the power to directly and more~     effectively confront a patient's barriers to medication adherence, reinforce the benefits~     and provide useful cues to action. Storytelling promotes patient engagement when the patient~     identifies with the storyteller and can lead to a patient's recognition of the need to treat~     the condition and improve health outcomes, as shown by a meaningful improvement in blood~     pressure in a recent clinical trial in AAs with hypertension. The success of this project,~     combined with other published data, will represent a major step toward demonstrating the~     effectiveness of storytelling to improve medication adherence in chronic diseases and will~     address two VA research priority areas, i.e., health care disparities and health care~     delivery.~   "
24114|NCT02741687|"~     The purpose of this study is to compare sitagliptin with a placebo for the prevention of~     high glucose after general surgery.~   "
24115|NCT02741674|"~     The main goal of this research project is to conduct a comparative effectiveness research~     study involving existing data in the PCORnet Common Data Model to provide accurate estimates~     of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures -~     Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus~     on outcomes that are important to adults and adolescents with severe obesity: 1) changes in~     weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.~   "
24116|NCT02741661|"~     This study is a retrospective analysis where coronary arteriograms are being analyzed to~     determine whether the presence of tortuous coronary arteries correlate with any specific~     measures of left ventricular mass or left ventricular function on echocardiography.~   "
24117|NCT02741648|"~     The purpose of this trial is to study the effect that anemia and Red Blood Cell (RBC)~     transfusions have on oxygen levels in the digestive tracts of Extremely Low Birth Weight~     (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that~     may lead to a better understanding of what makes an ELBW infant at risk for digestive tract~     problems such as necrotizing enterocolitis.~   "
24118|NCT02741622|"~     Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain~     derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the~     affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity~     dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the~     maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients~     with depression.~      The aim of this study is to compare changes in serum BDNF levels after~     high-aerobic-intensity training and long-slow-distance training in a intra-individual design~     in patients suffering from depression. The results will give indications of a possible~     difference in BDNF response between aerobic intensities and may be uses as pilot data for~     calculating sample size.~   "
24119|NCT02741609|"~     This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing~     Borrelia spirochetes from human serum in subjects with early or late Lyme disease.~      This is an 8 month study. Subjects entering the study will have two blood samples collected~     one month apart if they have early Lyme disease and one blood sample collected if they have~     late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and~     exclusion criteria will be entered into the study. Subjects will be assigned a subject~     number upon entry and this number will be retained throughout the study.~   "
24120|NCT02741596|"~     This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in~     preventing acute angioedema attacks in patients with Type I and Type II HAE.~   "
24121|NCT02741583|"~     prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma~     rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and~     asthma control.~   "
24122|NCT02741570|"~     The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study~     regimen as first line treatment in patients with recurrent or metastatic squamous cell of~     the head and neck cancer~   "
24123|NCT02741557|"~     The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination~     (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25~     mg versus co-administration of the separate tablet formulations of DTG 50 mg plus RPV 25 mg,~     in the fed state. This pivotal bioequivalence study, is to serve as a pharmacokinetic (PK)~     bridge to the ongoing Phase 3 trials with the separate agents. This study will be conducted~     under fed conditions to appropriately mimic the conditions in the Phase 3 trials. This is a~     single-center, randomized, open-label, 2-period, single-dose, crossover study. A minimum of~     86 healthy adult subjects will be randomized such that a minimum of approximately 82~     evaluable subjects complete the study. The total duration of participation of a subject in~     this study will be approximately 8 weeks which includes a screening visit within 30 days~     prior to the first dose of study drug, two treatment periods each with a single dose of~     study drug and a follow-up visit within 12-17 days after the last dose of study drug. There~     will be a washout of at least 21 days between each dose of study drug.~      A blinded (for treatment) review of DTG and RPV plasma concentration data for approximately~     the first 40 subjects will be conducted. If the within-subject coefficients of variation~     (CVw%) for either DTG or RPV maximal drug concentration (Cmax) values are >=31%; a sample~     size re-estimation will be employed and additional subjects (beyond the 86 planned) will be~     randomized for treatment in the study. Following the re-estimation, it is possible that up~     to approximately 154 healthy adult subjects (68 new subjects in addition to the planned 86~     subjects above) will be randomized such that a maximum of approximately 146 evaluable~     subjects could complete the study.~   "
24124|NCT02741544|"~     To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter~     referred to as Revlimid) in all patients who are treated with it under the actual condition~     of use pursuant to the conditions of approval.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled is~          reached.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end on the day when the approval condition related to all-case~          surveillance is terminated.~   "
24125|NCT02741531|"~     The purpose of this study is to determine if partially filling the bladder after~     laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to~     spontaneously void for patients to determine if this subsequently shortens patient stay~     times in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be~     compared to the current standard of care, which involves removing the patient's Foley~     catheter with an empty bladder and then giving the patient up to 6 hours to void in the~     PACU.~   "
24126|NCT02741518|"~     This is a randomized controlled pilot study to assess the microbiological and clinical~     impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The~     investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of~     35kg/m2 or higher) after providing written informed consent. The study participants will be~     randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will~     receive an induction FMT with capsules followed by a monthly maintenance dose of oral~     capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction~     followed by monthly intake of oral placebo capsules for 12 weeks.~   "
24127|NCT02741505|"~     The primary purpose of this study is to explore the underlying mechanisms that link sleep to~     Alzheimer's disease (AD), with special focus on the clearance of metabolites in the~     extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to~     determine regular daytime activity and sleep patterns. Subjects will then undergo partial~     sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG).~     Participants will be be asked to stay awake and active all day after the partial sleep~     deprivation with a new actigraphy secured by a hospital band to assure participants remain~     awake. They will seep inside an MRI machine for 90 minutes on the following night during~     their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow~     imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.~   "
24128|NCT02741492|"~     This study is designed to evaluate pain control of continuous transversus abdominis plane~     (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that~     there will be improved pain control when compared with sham blocks.~   "
24131|NCT02741453|"~     Central venous catheter placement is a common procedure in the intensive care unit and is a~     required skill for all residents working in the critical care setting. Central venous~     catheters (CVC) are placed for a variety of reasons including administration of caustic~     medications, administration of fluids or blood products for rapid resuscitation, access for~     hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or~     inability to obtain peripheral IV access. CVC's are routinely placed in the internal jugular~     vein in the Vanderbilt medical ICU and ultrasound guidance is used. Placement of the CVC on~     the right IJ instead of the left IJ is commonly preferred due to the more direct path to the~     superior vena cava. However, placement in the left IJ may be necessary for a variety of~     reasons. The investigators intend to compare the standard practice of residents and nurse~     practitioners placing IJ CVCs in the medical ICU against mandatory screening of the right~     and left IJ prior to selection of the CVC placement site. The investigators will accomplish~     this by assessing the relative first pass stick and overall success rates, the rate of~     aborted procedures, and the rate of complications between standard practice and mandatory~     screening of bilateral internal jugular veins prior to CVC site selection.~   "
24132|NCT02741440|"~     Background:~      Spinocerebellar ataxia type 7 (SCA7) is disease in which people have problems with~     coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A~     mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss.~     There is no cure for SCA7 but researchers are looking for possible treatments. Researchers~     need more information about SCA7. They want to collect vision and neurology related data~     from people with SCA7. They want to learn how and what changes in the eye and brain when the~     ATXN7 gene isn t working properly.~      Objective:~      To learn more about SCA7 and its progression.~      Eligibility:~      People ages 12 and older with SCA7.~      Design:~      Participants will be screened with medical history and genetic testing from a previous~     National Eye Institute study or their personal physician.~      Participants will have at least 7 visits over 5 years. They will have 2 visits during the~     first week of the study. Then they will be asked to come back every year for the next 5~     years. Each visit will last several days and will include:~        -  Medical and eye history~        -  Several eye tests: some will include dilating the pupil with eye drops and taking~          photos or scans of the eyes.~        -  Electroretinography (ERG): Participants will sit in the dark with their eyes patched~          for 30 minutes. After this, the patches will be removed and contact lenses put into the~          eyes. They will watch flashing lights and information will be recorded.~        -  Neurological exams: Sensation, strength, coordination, reflexes, attention, memory,~          language, and other cognitive functions will be tested.~        -  Brain MRI: They will lie in a machine that takes pictures of the brain.~        -  Blood and urine tests~        -  Optional skin biopsy: About 3 millimeters of skin will be removed for more research~          testing; this is half the size of a pencil eraser.~   "
24133|NCT02741427|"~     The purpose of this study was to compare the whitening effect of a toothpaste containing~     blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the~     subject's perception about tooth color improvement and; and evaluate the safety and~     acceptability of these products.~   "
24134|NCT02741414|"~     Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even~     falls into an unacceptable range. A major cause of treatment failure is associated with~     antibiotic resistance and poor patient compliance. However, the refractory infection of H.~     pylori is still existing, although patients have good compliance and receive standardized~     treatment. This phenomenon is likely attributed to the different ratio of sensitive and~     resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in~     vitro, the difference between phenotype and genotype or the influence of micro-environment~     in the stomach. In order to solve the refractory infection of H. pylori, investigators~     performed a muti-center study together with other 14 institutions. In this study,~     investigators will select the patients with refractory infection of H. pylori after two~     standardized treatment from patients with first eradication therapy of H. pylori infection.~     Then, investigators will perform a high-throughput sequencing for patients in groups.~     Finally, investigators will compare the differences between the patients with first~     successful eradication and patients with refractory infection of H. pylori, such as drug~     resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance~     and micro-environment in stomach.~   "
24135|NCT02741401|"~     The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is~     a prospective, randomized trial and executed at a Western referral Centre: Zuyderland~     Medical Centre located Sittard-Geleen, The Netherlands concerning patients who underwent~     surgery for gastrointestinal malignancy. During 5 consecutive days, the intervention group~     received postoperatively hand-foot massage administered by trained volunteers.~      The aim of this study is to investigate the effect of complementary therapies concerning~     quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who~     underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).~   "
24136|NCT02741388|"~     This is an open label, multicenter, dose escalation, phase Ib study to determine the~     recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and~     preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell~     malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation~     phase will be followed by an exploratory expansion phase in the same population with 12~     patients enrolled in each group, who will receive selinexor at the RP2D.~      The 3+3 design will be applied for dose escalation. The escalation will be performed~     independently in two distinct groups:~        -  Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)~        -  Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)~      The choice of the conventional immunotherapy regimen which will be administered to each~     patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before~     patient's inclusion. Different dose levels for selinexor administration will be examined~     sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per~     3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80~     mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle~     (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1~     and will continue until the MTD is exceeded or until the highest dose level defined in the~     study (DL3) is reached.~      Dose escalation to the next planned dose level will be decided by the DEC based on the~     number of DLTs observed during the DLT assessment period.~      The dose escalation phase will be followed by an exploratory expansion phase in the same two~     groups (Groups A and B), depending on the decision of the Independent Data Monitoring~     Committee (IDMC) after review of safety data at the end of dose escalation part.~      Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the~     IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the~     investigator's choice).~   "
24137|NCT02741375|"~     Aim: To investigate the efficacy of cerebral oximetry (CO) as an auxiliary diagnostic tool~     in confirming brain death (BD).~      Materials and Methods: This observational and interventional study was performed on patients~     with suspected BD in emergency departments and intensive care units. CO monitoring was~     performed for at least 6 h, and cerebral tissue oxygen saturation (ScO2) was recorded. Basal~     ScO2 values (basal ScO2), ScO2 values after 6 h (end ScO2), mean ScO2 values during~     monitoring (mean ScO2), and minimum (min ScO2) and maximum (max ScO2) ScO2 values observed~     during monitoring were recorded for all patients. Patients with diagnosis of BD confirmed by~     the organ transplantation and brain death committee were enrolled as the BD group and other~     patients as the non-BD group, and cerebral oxygen parameters were compared.~   "
24138|NCT02741362|"~     This is a Phase I-II open- label single-dose study in subjects with significant refractory~     Rheumatoid Arthritis (RA), relapsing Systemic Lupus Erythematosus (SLE) or Sharp's Syndrome~     (SS).~      This study will enroll a minimum of 20 subjects for RA, 20 subjects for SLE and 20 patients~     for SS. 6 week data of serum Tumor Necrosis Factor- alpha (TNFa), Interleukin- 6 (IL-6), C-~     Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Cluster of Differentiation~     (CD)4 +CD25 + Forkhead box P3(Foxp3) + regulatory T cells, Disease Activity Score for 28~     joints (DAS-28) score and pain score will be collected in all patients who are enrolled in~     the study for the RA group (Baseline and 6 weeks after). For the SLE group, Transforming~     Growth Factor- beta (TGF-β), TNFa, IL-6, Interleukin- 17 (IL-17), CD3+CD8-IL17A+ T helper-17~     (Th17) cells, CD4+CD25+Foxp3+ regulatory T cells and the Systemic Lupus Erythematosus~     Quality of Life Questionnaire (SLEQoL) score will be collected in all the subjects of this~     group. SS group will undergo the assessments of RA and SLE. Prior to the stem cell~     treatment, the patient will be assessed for 6 weeks by all the previously mentioned markers.~     Then, patients will receive the infusion of stromal vascular fraction cells containing the~     adult adipose derived stem cells 'aADSC' (single intravenous dose). The disease- modifying~     anti-rheumatic drugs (DMARDs) or the standard SLE treatment will not be interrupted with the~     exception of systemic steroids (excluding minimal maintenance dose of one steroid) during~     the duration of the study. Follow up visits will take place at 6 weeks, 3 Months and 6~     Months after the cell infusion. Safety will be monitored on an ongoing basis, and an interim~     safety review will be conducted by the Investigator(s) and Sponsor after the first 10~     patients have been enrolled and treated in each group.~   "
24139|NCT02741349|"~     The aim of the present prospective study is to further develop and validate a composite risk~     score predicting both ischemic and bleeding risk, based on epidemiologic, clinical,~     biological, and/or morphologic complementary data. First, the investigators will assess the~     predictive performance of current clinical risk scores. Second, the investigators will~     assess the potential predictive value of additional markers. Third, the investigators will~     aim to develop a new risk score.~   "
24140|NCT02741336|"~     Insomnia is a highly prevalent, often debilitating, and economically burdensome condition.~     Reviews of the literature indicate that there are ethnic differences in sleep behavior, with~     African Americans objectively and subjectively reporting more disordered sleep than~     Caucasian Americans.Chronic insomnia can have a significant impact on mental and physical~     health outcomes and has been associated with impaired cognitive performance, particularly,~     in areas of speed, attention, working memory, and executive function. In order to understand~     the brain mechanisms in sleep disorder both during resting state as well as during cognitive~     processing, the investigators will assess resting state EEG (during eyes-closed and~     eyes-open conditions) as well as ERP tasks for assessing decision-making and reward~     processing. The primary objective of the study is to evaluate the effect of a tailored,~     telephone-delivered cognitive behavioral intervention, versus a self- monitoring control~     condition, on symptoms of insomnia and its neurodynamic correlates.~      Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to~     the tailored, telephone-delivered CBT-I, compared with those randomized to the~     self-monitoring control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia~     as measured by the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic~     improvement (ERP, ERO) in the intervention condition in response to laboratory paradigms Hyp~     3: Greater improvement in psychosocial functioning including reduction in depression and~     increase in quality of life.~   "
24141|NCT02741323|"~     Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate~     the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.~   "
24142|NCT02741310|"~     Single center, parallel-group, double-blind, placebo-controlled concomitant therapy study in~     healthy subjects~   "
24143|NCT02741297|"~     The primary objective of this study is to characterize the real-world outcomes of spinal~     cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of~     the trunk, including unilateral or bilateral pain associated with the following: failed back~     surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION~     Spinal Cord Stimulator System with MultiWave Technology.~   "
24144|NCT02741284|"~     Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is~     common practice on Labor and Delivery units in the United States. Despite the broad use of~     oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this~     study is to compare oxygen to room air in patients with Category II fetal heart tracings~     with regard to neonatal acid-base status, subsequent tracings, and production of reactive~     oxygen species~   "
24145|NCT02741271|"~     This study will compare the efficacy and safety of mometasone furoate/formoterol fumarate~     (MF/F) 100/10 mcg to mometasone furoate (MF) 100 mcg, both administered by metered-dose~     inhaler, in 5- to 11-year-old children with persistent asthma. This study will evaluate the~     change in forced expiratory volume in one second (FEV1) from baseline as a measure of~     pulmonary function~   "
24146|NCT02741258|"~     This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity~     due to radiotherapy in patients with post-surgery breast cancer.~      Mepitel film will be placed on the skin of the patients just before the start of the~     radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of~     skin toxicities mepitel film will be placed until resolution of toxicities.~   "
24147|NCT02741245|"~     This study will evaluate the efficacy and safety and tolerability of 2 dose levels of~     MK-0653H in Japanese participants. The primary hypotheses are that the administration of~     MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe~     and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol~     (LDL-C) after 12 weeks of treatment.~   "
24148|NCT02741232|"~     In this study, the investigators will compare the intraoperative opioid consumption for~     patients undergoing breast cancer surgery. The patients will be divided in two groups, the~     first one will receive a pectoral nerve block right after induction of anesthesia and the~     second one, the control group, will not receive the pectoral block. Our hypothesis is that~     the pectoral nerve block reduces the opioid consumption during the surgery.~   "
24149|NCT02741219|"~     The purpose of this multicenter study is to evaluate the effectiveness and safety of~     dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean~     section~   "
24150|NCT02741206|"~     This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out~     Stay Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal~     intervention that provides women with psycho-education about maternal depression and~     strategies for strengthening social support and connectedness. Investigators use~     motivational interviewing strategies to improve treatment compliance and resource~     acquisition~   "
24151|NCT02741193|"~     The aim of the study is to examine the degree of concordance between presurgical~     neuronavigation guided TMS (nTMS) and direct cortical stimulation (DCS) in identifying hand~     motor cortex in adults undergoing epilepsy surgery.~      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation~     will be delivered to hand primary motor cortex, with positive and negative functional sites~     determined through surface electromyography (EMG).~      The study will involve patients ages 12-60 years, with planned neurosurgery involving~     implantation of intracranial subdural electrodes including over the precentral gyrus.~      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation~     will be delivered to hand primary motor cortex, with positive and negative functional sites~     determined through surface electromyography (EMG).~      The primary outcome measure will be spatial correlation between topographic maps of hand~     motor representation obtained through nTMS compared to direct, extra-operative cortical~     stimulation performed as part of routine clinical care. A secondary outcome measure will be~     safety and tolerability of TMS in the epilepsy patients.~   "
24152|NCT02741180|"~     The primary purpose of this study is to improve the quality of Magnetic Resonance Imaging in~     patients with heart arrhythmia. Investigators will recruit 105 patients with arrhythmia and~     30 control volunteers over 3 years and will use two arrhythmia-tolerant imaging methods for~     diagnosis.~   "
24153|NCT02741167|"~     The purpose of this study is to assess the dynamics of inflammatory parameters in presence~     or absence of infectious complications after cytoreductive surgery with hyperthermic~     intraperitoneal chemotherapy.~   "
24154|NCT02741154|"~     study the effect of aromataze inhibitor induction together with short stimulation protocol~     by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder~     before ICSI~   "
24155|NCT02741141|"~     In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour~     was 21 % and 16% to 38% in case of dystocia.~      The definition of  dystocia  is traditionally based on the research led by Friedman in the~     1950's on a restricted population sample. Several studies over the last years seem to~     indicate that the different phases of labour are longer than originally described by~     Friedman.~      Our current hypothesis is that the application of a new definition of dystocia would enable~     a more appropriate management of labour.~   "
24156|NCT02741128|"~     The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a~     population of special interest, such as HIV-positive adults.~      Primary Objective:~        -  To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults.~      Secondary Objectives:~        -  To describe the humoral immune response to each dengue serotype at baseline and after~          each injection of CYD dengue vaccine in HIV-positive adults.~        -  To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults.~        -  To describe changes in CD4 count and HIV RNA viral load after each injection of CYD~          dengue vaccine in HIV-positive adults.~      Observational Objective:~        -  To describe the FV (YF, Dengue) serological status in the study population at baseline.~   "
24157|NCT02741115|"~     This study will evaluate the clinical efficacy and safety of udenafil, an orally~     administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of~     adolescent subjects who have undergone the Fontan procedure.~   "
24158|NCT02741102|"~     This study will examine the feasibility of initiating a uterine transplant program for~     Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The~     investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and~     5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine~     Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five~     years of follow-up is planned.~   "
24159|NCT02740933|"~     This research study is studying a drug called Demeclocycline that may help brain surgeons~     see tumors with a microscope during surgery.~   "
24160|NCT02740920|"~     Studies have shown that the study drug, pembrolizumab, works by helping the immune system.~     In this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells~     to die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients~     lived overall and the time without their cancer getting worse.~   "
24161|NCT02740907|"~     Objective:~      Premolar autotransplantation represents an effective therapeutic option for the treatment of~     juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on~     the osteoinductive potency of the method, however, to date no quantitative data has been~     provided. The objective of this prospective clinical study was to quantitatively assess the~     bone and soft tissue levels after autogenous premolar transplantation by clinical and~     radiographic parameters.~      Materials/Methods:~      In the study 26 premolars were transplanted in 20 patients after traumatic dental injury~     (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were~     evaluated. Based on a standardized photo documentation, the relative soft tissue level was~     measured in comparison to the healthy adjacent teeth. Radiographic findings involved the~     evaluation of root resorption, pulp canal obliterations and the relative bone height.~     Patient satisfaction was determined using a standardized questionnaire.~   "
24162|NCT02740894|"~     Not significantly increased survival in T/T~   "
24163|NCT02740881|"~     Adolescent substance abuse results in significant negative outcomes and extraordinary costs~     for youths, their families, communities and society (societal costs estimated at over $400~     billion annually and greater than costs for any other health problem). There is a clear~     public health need for improving and expanding the delivery of evidence-based treatments for~     adolescent substance use, but despite this clear need, there is a large divide between~     science and practice. This project will develop a cost-effective, easily accessible,~     web-based Training Support System (TSS) for Contingency Management that incorporates ongoing~     training, feedback, and support provided to both counselors and their community-based~     agencies.~   "
24164|NCT02740868|"~     Aim of this study is to evaluate image quality and reproducibility of Xenon-129 Magnetic~     Resonance Imaging (MRI) and to evaluate changes in lung structure and function in~     participants with cystic fibrosis (CF) and asthma compared to healthy controls using~     Xenon-129 MRI.~   "
24203|NCT02740361|"~     This is an international, multicenter, randomized controlled trial of an internet-based CBT~     intervention for depression (Deprexis) conducted in five MS centers in the US and Germany.~     The trial consists of a three-arm primary trial phase and an extension phase targeted at~     maintenance.~   "
24165|NCT02740855|"~     During the ethanol sclerotherapy procedure, the investigators will record doses of and time~     of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes.~     Furthermore after every ethanol injection the concentration will be measured every minute~     for 5 minutes. To do so, the investigators will attach a breath alcohol testing device to~     the expiratory carbon dioxide measuring unit. Since this is the new standard of the~     university hospital Berne all patients undergo the same procedure. There is no study~     specific intervention. In this study the investigators will only document the breath alcohol~     levels, doses and timing of ethanol injections. All other data will be obtained from the~     anesthesia information system. During the two months of the study, the investigators will~     also record endtidal ethanol concentration after anesthesia in the postoperative care unit~     discharge from the unit.~      The intention is to show the correlation between injected ethanol doses and measured~     endtidal ethanol concentration over the entire time of the intervention.~   "
24166|NCT02740842|"~     Alive & Thrive (A&T) is a multi-year initiative to improve infant and young child feeding~     (IYCF) practices. During Phase 1 (A&T-1, 2009-2014), funded by the Bill & Melinda Gates~     Foundation, A&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices~     in three countries - Bangladesh, Ethiopia, and Viet Nam.~      In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The~     overall findings of the evaluation indicate that A&T's work in Bangladesh is a remarkable~     success story of scaling up what has been challenging to date in the field of nutrition:~     complex, high intensity and at-scale behavior change communications interventions.~      In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF~     practices, expansion of operations and promoted practices into new areas, and diffusion of~     IYCF information, two years after the termination of external project support.~   "
24167|NCT02740829|"~     Peripheral glucagon action increases hepatic glucose production. In rodents hypothalamic~     action of glucagon paradoxically suppresses glucose production. Intranasally administered~     peptides have been shown to preferentially enter the central nervous system. We assessed the~     effects of intranasal glucagon on hepatic glucose production~   "
24168|NCT02740816|"~     The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if~     menstrual blood could be utilized as a natural and non-invasive access to blood for regular~     health monitoring and early diagnostics.~   "
24169|NCT02740803|"~     Caries prevalence has declined significantly since the introduction of fluoridated~     toothpastes. Since then, different toothpaste formulations and concentrations have been~     introduced to the market with varying levels of efficacy. There are several commercially~     available toothpastes to choose from and only with the aid of sound methodological research,~     can the best evidence-based oral education advice be delivered.~      This is a double-blinded randomised controlled trial that aims to measure the salivary~     fluoride concentration following tooth-brushing with several toothpaste formulations. Power~     calculations were performed using PASS 11.0 software, and calculations showed that 3~     participants are needed in each group in order for results to be considered as significant.~     We will aim to recruit five to seven participants in each of the 12 groups. Research will be~     publicised by means of flyers and circulating emails amongst University of Leeds students.~     Information sheets will be provided to all participants and informed consent will be~     obtained.~      Each participant will brush with one of 6 different formulations of toothpastes either with~     or without water rinsing post-brushing. Participants will randomly be assigned to groups~     using an online random team generator. Saliva will be collected six times once before~     brushing and at 1, 15, 30, 60 and 90 minutes post-brushing. Samples will be analysed using~     fluoride ion-specific sensitive electrode connected to an ion analyser.~      A statistician's help will be sought for analysis of the results. After the analysis stage,~     the codes of the toothpastes will be broken.~   "
24170|NCT02740790|"~     Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16~     and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune~     response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to~     18-26 years age group and 27-45 years age group in terms of immunogenicity.~   "
24171|NCT02740777|"~     To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose~     immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle~     vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in~     adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6~     months) in young females aged 18 to 26 years.~   "
24172|NCT02740764|"~     Aging is often associated with multiple chronic conditions conducting increased consumption~     of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of~     drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy,~     increases the iatrogenic risks and can lead to adverse events such as falls, cognitive~     decline, increased use to the health system: hospital admissions, emergency room visits, and~     institutionalization. These problems are common since about 20% of emergency room use in~     elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events~     related to drug prescriptions could be avoided.~      Interventions to optimize drug therapy showed a reduction in the number of potentially~     inappropriate medications, but their impact on health, has rarely been evaluated. If an~     association with death has been established, the link with the loss of functional autonomy,~     which leads to reduced quality of life and significant cost of care, has not been~     investigated. The evolution towards functional disabilities, frequent with aging has many~     causes, among which some could be prevented. The optimization of drug prescriptions could~     thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse~     events, such as falls or cognitive decline and improving the management of chronic diseases.~     Our hypothesis is that an optimization program of the drug prescribing may slow progression~     to functional dependence. To assess the effect of the optimization program of drug~     prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial~     will be conducted in geriatric and memory consultations.~      Expected results The implementation of the OPTIM program should enable optimization of~     drug prescribing in elderly patients and therefore slow or prevent progression to addiction.~     It should also help to develop and strengthen collaboration and communication between the~     team of geriatric consultation, the clinician pharmacist and referring physicians in town~     (private practice). In addition, pharmaceutical notice sent to referring physicians should~     help raise awareness of the prescription of drugs in these patients.~   "
24173|NCT02740751|"~     Herbal teas with galactogoge effects have been used extensively in recent years in order to~     increase the amount of breast milk in lactating mothers. We also investigated whether a~     sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these~     mothers. Plain water was used as placebo.~   "
24174|NCT02740738|"~     To investigate the association between grip strength and preoperative pain threshold as~     measured by pressure algometer and validated pain outcome surveys.~   "
33991|NCT02612155|"~     This study will test the safety and efficacy of an infusion of a baby's own (autologous)~     umbilical cord blood as compared with placebo in babies born with history and signs of~     hypoxic-ischemic brain injury.~   "
24175|NCT02740725|"~     Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a~     complementary method of patching in amblyopia therapy.~      Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic~     children (25 male/25 female) less than 10 years with either best corrected visual acuity~     (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of~     VA≥2 lines between two eyes will be included. Patients will be classified in the case and~     control groups (25 in each), randomly. Patching will be recommended in both, cases will also~     received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with~     conjugate colored filters. Patching was continued for one month more in both groups. VA and~     stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one~     month after I-BiTTM treatment.~   "
24176|NCT02740712|"~     The purpose of this study is to assess pharmacokinetic concentrations of multiple probes~     alone followed by assessment of the same drug pharmacokinetic concentrations when the~     patient has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with~     rucaparib continuing until disease progression or other reason for discontinuation.~   "
24177|NCT02740699|"~     Background:~      Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease.~     Drugs called statins might shrink plaque. Researchers want to study how CT scanning can~     determine if an individual s arterial plaque has decreased while taking statins.~      Objectives:~      To measure the change in coronary artery plaque volume in people treated with high-intensity~     statin therapy using CT and MRI scans. To study the metabolic activity of plaque in~     arteries. To determine how well plaque measurements from heart CT scans can be replicated.~      Eligibility:~      Men ages 45-75 and women ages 50-75 who are good candidates for statin treatment~      Design:~      Visit 1: participants will be screened with:~        -  Medical history~        -  Blood tests~        -  Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and~          injects~      contrast, and medicine if needed. Participants lie on a table that slides into a machine~     that takes pictures of the body. For the CT scan, if their heart rate is too high, they get~     medicine to lower it. They breathe in a special way, holding their breath for 5 seconds.~      Participants will begin high-intensity statin treatment.~      Participants will have 7 more visits over 3 years. All visits include blood tests and~     medication review. Some may also include:~        -  Statin treatment adjustment~        -  CT scan~        -  MRI scan~        -  Physical exam~      Participants may join the PET Substudy. This includes 5 more visits during the study. These~     include:~        -  Getting an IV in an arm vein~        -  Blood tests~        -  PET scans: They fast 12 hours before.~      Participants may join the Reproducibility Substudy if they had a slow heart rate during~     their first CT scan. This includes 1 additional heart CT scan 4 weeks later.~   "
24178|NCT02740686|"~     This study will examine the inflammatory response to exercise encompassed as part of a~     standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary~     disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent~     exacerbators, dependent upon exacerbation history to compare responses to pulmonary~     rehabilitation amongst phenotypes.~   "
24179|NCT02740673|"~     Little is known about the causes and degree of cognitive dysfunction in patients with~     Chronic Obstructive Pulmonary Disease (COPD), especially their driving abilities. The~     purpose of the study is to examine the cognitive skills of patients with COPD by using a~     driving simulator and to examine correlations to factors that may predict cognitive~     dysfunction in these patients.~   "
24180|NCT02740660|"~     The purpose of this study is to determine whether taking a combination of caffeine and~     albuterol three times per day will increase muscle and decrease fat in your child's body and~     to determine how these medications make your child feel. Albuterol is approved by the FDA~     for the treatment of asthma. It is not approved to increase muscle and decrease body fat in~     children.~   "
24181|NCT02740647|"~     Orthognathic surgery is the state of art of the maxillofacial surgery, it fix and normalize~     facial abnormalities and create a harmony between the different tissues compounding the face~     (bone, soft tissue and dental structures). It is a common procedure and it is done in order~     to correct a dentofacial and skeletal deformities.~      There is an inevitable risk of complications with this type of surgery. While postoperative~     infections are the most common complication (2% to 33.4%).~      preoperative administration of antibiotics have been proven to be effective in reducing the~     postoperative infection rate, while, the quality of the currently available literature in~     prescribing continues postoperative antibiotics is questionable and there is still no~     consensus on its efficacy.~      Unwise administration of antibiotics may cause several unwanted side effects such as~     gastrointestinal symptoms, allergy reactions, high costs, etc… while the most worrisome side~     effect is a bacterial resentence.~      The objective of this study is to investigate the efficacy of postoperative antibiotics. And~     will try to state a consensus in prescribing postoperative antibiotics. By conducting a~     prospective, randomized, double-blind, placebo-controlled study, that will explore and~     analyze the efficacy of postoperative administration of Amoxicillin Clavulanate versus~     placebo in reducing the rate of postoperative infections in 60 healthy patients.~   "
24182|NCT02740634|"~     This is a neuroimaging study designed to learn more about amyloid and tau burden in the~     brain of patients with Atypical Alzheimer's Disease and how burden may change over a~     two-year period.~   "
24183|NCT02740621|"~     In this study, the risk of opioid medications on coronary heart disease in adults is~     investigated. Patients with the necessity of a coronary angiography and control patients~     with a non-cardiac disease of the same hospital are inquired with a standardized~     questionnaire about demographic and clinical risk factors for heart attack. An impact of~     opioid medications on coronary heart disease is hypothesised.~   "
24184|NCT02740608|"~     This study is designed to determine if a rejected liver is viable using normothermic machine~     liver perfusion (NMLP). It aims to~        1. establish the suitability of livers which have been declined by all UK liver transplant~          centres by monitoring their function on the NMLP machine; and,~        2. transplant the liver if its function on the machine is satisfactory allowing it to be~          transplanted.~   "
24185|NCT02740595|"~     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and~     sham control, on endothelial function and markers of oxidative stress.~   "
24188|NCT02740556|"~     There is limited data outside of clinical trials on adherence to once daily~     ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication~     adherence including untreated psychiatric illness and substance use disorders, cognitive~     impairment, and low health literacy. The goal of this study is to evaluate the baseline~     level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare~     this to the level of adherence in patients provided with additional adherence support.~     Medication adherence in this study will be evaluated using AdhereTech, a wireless pill~     monitoring device that measures the dosage and time a medication was taken. Using cellular~     technology, AdhereTech can be used passively to collect data on when a medication is taken,~     when a refill is needed, and how often the bottle is opened. AdhereTech also can be used~     actively to monitor adherence and provide feedback to subjects using the device. When~     actively monitoring, AdhereTech can be set up to provide live feedback to a subject by~     lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take~     their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in~     the form of a dashboard for medical providers (MDs and NPs) and an application (or app)~     for patients. The app allows patients to become active participants in their treatment by~     enabling them to set medication reminders, record doses taken, and communicate their~     adherence to their medical provider using the provider dashboard.~   "
24189|NCT02740543|"~     Asthma is a heterogeneous disease, and although much is understood about mechanisms of~     inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma~     (IA). Understanding the underlying similarities and differences in mechanisms of these two~     types of asthma will help focus current treatments and lead to development of new therapies.~     There is a longstanding NYU/Bellevue Asthma registry (NYUBAR), with a large population (N =~     900) of asthma cases and controls, a program that has been housed at the CTSI (formerly~     GCRC). The destruction of the World Trade Center (WTC) resulted in massive dust, gas and~     fume exposures to local residents, workers and cleanup workers and individuals involved in~     rescue and recovery and adverse respiratory health effects of this disaster are reported~     more than 7 years after 9/11. Many responders, as well as those exposed as residents or~     local workers, have developed IA, asthma that arises after a lag from an environmental~     exposure . The WTC Environmental Health Center (WTC EHC) is one of the three New York City~     (NYC) WTC Centers of Excellence and the only one that focuses on treatment and monitoring of~     local workers and residents. As such, it has a large population of individuals with~     irritant-induced asthma. It has been proposed to use participants from the NYUBAR and the~     WTC EHC to expand the knowledge of irritant and allergic asthma. Non-invasive studies allow~     for the assessment of airway inflammation, a non-specific response to environmental exposure~     and injury. Recent technologies also allow for assessment of microRNA (miRNA), small RNAs~     that regulate gene expression at the post-transcriptional level and thus serve as a pathway~     to regulation of inflammation. The hypothesis will be tested in that airway inflammation in~     irritant and allergic asthma may be similar, but result from divergent miRNA regulatory~     pathways expressed in sputum cells. These studies will provide preliminary data for future~     studies that will help identify biological pathways to categorize these asthma phenotypes~     and target future treatment interventions.~   "
24190|NCT02740530|"~     This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS),~     known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility,~     particularly gait stability and variability, and executive dysfunction in older adults. The~     study will be conducted in forty older adults (≥60 years) with a diagnosis of executive~     dysfunction.~   "
24191|NCT02740517|"~     Trial to demonstrate that the intended user population can use the device unsupervised in~     the home and collect data that is of sufficient quality to be successfully analysed for~     respiration rate.~   "
24192|NCT02740504|"~     A trial conducted within the company with a new non-contact respiration rate (RR) sensor.~     The device was compared for accuracy in RR measurement with a cleared device, the~     SOMNOScreen Easy, which uses chest effort bands.~      The RR was measured over a short duration on subjects sitting upright in a chair, with the~     non-contact sensor at various distances from the subject. A total of 20 subjects were~     tested, from both genders, selected to represent a wide range of age and body mass index~   "
24193|NCT02740491|"~     The main objective of this study is to describe the evolution in quality of life (QLQ-C30)~     for patients receiving breast cancer care at 3, 6 and 12 months after a remission~     consultation.~   "
24194|NCT02740478|"~     The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in~     performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects~     over a number of hours when the subjects are lying still or in bed asleep~   "
24195|NCT02740465|"~     This prospective, multicenter, cohort study is designed to validate Anxiety Inventory~     Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease~     (COPD).~      The primary purpose of this study is to assess the validity of the Anxiety Inventory~     Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients~     with COPD.~        -  To evaluate associations between COPD symptom scores assessed by the CAT questionnaire~          and MMRC dyspnea scale and measures of depression and anxiety~        -  To evaluate associations between physiologic measures of lung function (spirometry) and~          exercise tolerance (6 minute walk) and measures of depression and anxiety~        -  To evaluate associations between exacerbations of COPD and the prevalence of anxiety~          and depression in a cohort of COPD patients~   "
24196|NCT02740452|"~     The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical~     technique versus standard technique.~      The aim of the study is to compare (laxity, instability, and safety) these two types of~     treatment by using a prospective, randomised multicenter analysis.~   "
24197|NCT02740439|"~     The proposed work will investigate the effects of avocados on abdominal obesity and glycemic~     control among overweight/obese adults.~   "
24198|NCT02740426|"~     This clinical trial is designed to evaluate the efficacy of single immediate intravesical~     chemotherapy instillation in the prevention of bladder recurrence after diagnostic~     ureteroscopy for upper tract urothelial carcinoma (UTUC) patients.~   "
24199|NCT02740413|"~     The overall aim of the study is to describe demographic and clinical characteristics,~     treatment patterns and outcomes, in the populations of hemophilia patients treated with~     BeneFIX and ReFacto/ReFacto AF in Sweden~   "
24200|NCT02740400|"~     This is a randomized controlled trail aiming at comparing the diagnostic value and safety of~     endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided~     transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients~     eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly.~     The diagnostic indicators such as sensitivity, specificity, and accuracy are compared~     between the two groups. Post-procedure complications are recorded.~   "
24204|NCT02740348|"~     The purpose of this trial is to determine whether setting up a follow-up appointment for~     patients who received treatment and were discharged from the emergency department increases~     their compliance with the follow-up appointment. We are enrolling patients who need a~     follow-up visit, have health insurance but report do not have a primary care doctor.~     Patients are randomized to one of three treatment groups: (1) assistance setting up a~     follow-up appointment by a research assistant using ZocDoc; (2) ZocDoc information given to~     the subject to set up follow-up appointment by him/herself; or (3) usual discharge~     instructions by ED staff. Subjects are phoned approximately 2 weeks after the ED visit and~     asked whether they completed a follow-up visit, satisfaction with their ED visit,~     satisfaction with their follow-up visit, and additional ED treatment and recovery.~   "
24205|NCT02740335|"~     To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K~     Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is~     clinically non-inferior to that Beriplex® P/N (Kcentra).~   "
24206|NCT02740322|"~     The sensitivity and specificity of the Hum Test is being investigated in it's ability to~     detect conductive hearing loss. The hum test is simply elicited by asking the subject to hum~     to him or herself for a few seconds at both a high and low pitch that is comfortable for the~     subject. The subject is then asked if the hum was heard on one side more than the other~     (left or right), or if the sound was equal on both sides. To simulate conductive hearing~     loss, ear plugs will be placed in one of the subject's ears. We will elicit the hum test as~     well as the standard Weber test and audiogram across two conditions, with an ear plug and~     without an ear plug. From this, it is hoped to assess how the Hum Test compares to the~     audiogram (gold standard) in detecting conductive hearing loss as well as how it compares to~     the standard Weber test. If the Hum Test demonstrates strong sensitivity and specificity in~     detecting conductive hearing loss, it could have application as being utilized as an~     alternative to the standard Weber test, or in a setting where a formal physical examination~     may not yet be possible but where the etiology of a patient's hearing change could be~     quickly assessed remotely and thus the urgency of intervention/ consultation could then be~     determined.~   "
24207|NCT02740309|"~     Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will~     be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child~     Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric~     gastroenterology clinic. Individuals who screen positive for depression or anxiety will be~     assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also~     complete a psychosocial risk assessment as well as medical and socio-demographic~     inventories. The investigators will include youth that meet full criteria for major~     depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment~     disorder. The investigators will also include patients with subclinical symptoms that have~     significant psychosocial stressors in addition to their medical illness. Patients will be~     excluded if they have active suicidal ideation with plan requiring ER referral, bipolar~     disorder, psychosis, substance dependence, eating disorders, or significant intellectual~     disability/developmental delay. Participants meeting inclusion criteria will be randomly~     assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment~     as usual (TAU), which is a facilitated community referral for mental health treatment.~   "
24208|NCT02740296|"~     Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time~     prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more~     frequently in MS than in other chronic diseases including other neurological and~     inflammatory disorders and may contribute to lower quality of life, cognitive problems,~     difficulties at work, and poorer long term health outcomes. Despite its clinical relevance,~     the biological mechanisms which may be responsible for the high risk for MS patients to~     develop depression are unknown.~      In this observational study, investigators explore the molecular mechanisms responsible for~     the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with~     depression. Investigators will compare the molecular and phenotypical profile of immune~     cells obtained from RRMS patients with clinical depression (n=50), matched MS patients who~     do not suffer from depression (n=50) as well as matched healthy controls (n=50) and matched~     patients with depression but without a comorbid neurological disorder (n=50).~   "
24209|NCT02740283|"~     The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an~     early diagnosis method of GDM in low risk pregnant women. By investigating maternal and~     neonatal outcomes that are associated with the early OGTT and regular OGTT results, the~     study will provide a evidence for the most appropriate time to perform an OGTT in pregnant~     women.~   "
24210|NCT02740270|"~     The purpose of this trial is to explore the clinical utility of two investigational~     antibodies in patients with advanced cancer or lymphomas.~      This is a multi-center, open-label Phase I/Ib study. The study consists of two dose~     escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in~     combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test~     different dosing schedules.~      The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation~     part to assess the activity, safety and tolerability of the investigational products in~     patients with specific types of cancer and lymphomas.~      Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.~   "
24211|NCT02740257|"~     The primary objective of Part One of this study is to determine the sensitivity of an~     automated total body digital photography (TBDP) app to detect color and size changes in the~     human skin, and whether a new lesion has arisen.~      The primary objective of Part Two is to test the sensitivity and specificity as well as~     feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin~     lesions in high risk populations.~   "
24212|NCT02740244|"~     The aim is to evaluate the evaluate the clinical interest and the safety of repetitive~     transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst~     stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar~     disorder.~   "
24270|NCT02739490|"~     Introduction: The stability of the pelvis is of great importance in body balance as a whole,~     can be improved by training the pelvic muscles fillet (MLP), which is characterized by low~     intensity isometric synchronous and the deep muscles of the trunk. This study aims to~     determine the effect of a stability program target, with the training of the MLP region on~     pelvic stability.~   "
24213|NCT02740231|"~     Osteoarthritis (OA) is the most common joint disease affecting millions of people around the~     world, for which there is unfortunately no cure. Among existing therapies,~     viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an~     established place in the symptomatic treatment of knee OA.~      The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized~     in two phases. With results obtained in the first phase the best dose of JTA-004 is~     determined, and the efficacy of the selected dose will then be confirmed in the second~     phase.~   "
24214|NCT02740218|"~     This is a retrospective, multi-center observational cohort study. This study will be~     implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20~     sites) and Sweden (approximately 25 sites), followed by a selected number of countries in~     Europe, depending on apremilast local availability. The design of this apremilast~     retrospective study aims to provide clinical information regarding the treatment initiation~     and outcomes in psoriasis patients when prescribed apremilast in real world settings. In~     addition, this study is aiming at capturing physicians' and patients' treatment goals when~     initiating apremilast and whether these goals are achieved following apremilast use. This~     study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients~     must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with~     plaque psoriasis and have been treated with apremilast during the previous 5-7 months to~     participate in this study. They must not be involved in any other clinical study involving~     apremilast.~   "
24215|NCT02740205|"~     The purpose of this trial is to evaluate the efficacy and safety of the implementation of an~     Algorithm for enteral nutrition support compared with usual standard practice in~     non-critical hospitalized patients: ASNET algorithm.~   "
24216|NCT02740192|"~     This is a randomized, double blinded, standard of care controlled clinical trial. All adult~     patients over eighteen desiring total knee arthroplasty will be eligible. The study compares~     pain control, opioid consumption, and physical exam findings in patients undergoing total~     knee arthroplasty between patients receiving adductor canal block and those who receiving~     periarticular injection alone.~   "
24217|NCT02740179|"~     HIV-infected individuals treated with antiretroviral medications are living longer, but have~     an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone~     called aldosterone, which regulates blood pressure and sodium balance, is elevated in the~     HIV population in association with with increased belly fat and altered glucose metabolism.~     Elevations in aldosterone hormone may also be associated with abnormal blood flow,~     inflammation, and coronary plaque in the heart. This study is being conducted to evaluate~     whether therapies to reduce the actions of aldosterone may decrease the burden and~     progression of heart disease in the HIV population.~   "
24218|NCT02740166|"~     Esophageal variceal bleeding is a severe complication of portal hypertension. Banding~     ligation plus non-selective beta-blockers is the current recommendation for prevention of~     recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is~     not well defined. This study aims at comparing the rebleeding rate and adverse effects in~     patients using or without using propranolol after eradication of esophageal varices.~   "
24219|NCT02740153|"~     Urea cycle disorders (UCD) are genetic disorders caused by the liver's inability to~     breakdown ammonia from proteins; ammonia then accumulates and is toxic to the brain. UCD~     cause brain damage and intellectual and developmental disabilities and even death.~      Treatment for UCD is either conservative management which involves a low-in-protein diet,~     drugs, and amino acid supplements or liver transplantation; each carry their own risks.~      This study aims to help patients to make decision about different management alternatives by~     providing them with scientific information that is currently lacking.~      Aim 1 of this study will compare survival, neurocognitive function, and patient reported~     quality of life. Aim 2 of this study will consist of interviews and focus groups with~     patients, their families, and their medical providers to determine important issues to~     consider when deciding whether to continue conservative management or opt for liver~     transplantation.~   "
24220|NCT02740140|"~     This observational epidemiologic study with nested cross-sectional and longitudinal aims~     will evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent~     tuberculosis, intestinal helminthiasis) in recent US immigrants.~   "
24221|NCT02740127|"~     During penile prosthesis surgery, participants are given general anesthesia in combination~     with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the~     tailbone, in addition to general anesthesia, which can lower the need for pain drugs.~      The goal of this clinical research study is to learn how effective CNBs are in participants~     who are having penile prosthesis surgery compared to participants who only have general~     anesthesia by studying how long participant stays in the hospital and the level of pain they~     have after surgery.~   "
24222|NCT02740114|"~     Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites.~     Liposomes are molecules that are similar to fats. Sometimes drugs are combined with~     liposomes to make them able to stay in the body for longer periods of time. This has been~     done with bupivacaine to create liposomal bupivacaine.~      The goal of this clinical research study is to compare the effects of bupivacaine to those~     of liposomal bupivacaine when given to patients who are having gynecologic surgery.~     Researchers want to compare how long the drugs work to numb the wound and how long patients~     take to recover from surgery.~   "
24223|NCT02740101|"~     To examine potential differential effects of receiving various social feedback on achieving~     personal goals,and whether oxytocin would modulate these effects.~   "
24224|NCT02740088|"~     This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic~     valve could predict aortic stenosis progression in moderate aortic stenosis.~      Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation~     including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up~     echocardiography. The study design is an observational trial. Primary endpoint was a change~     in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year.~     Secondary endpoints include changes in aortic valve area, and symptom occurrence.~   "
24271|NCT02739477|"~     This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus~     Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3~     cohorts of 6 patients, each dose level including 2 sentinel patients.~   "
24225|NCT02740075|"~     After cardiac surgery patients are transported from the operating room (OR) to the intensive~     care unit (ICU) while intubated. Two principal methods of oxygenation and ventilation are~     used: (1) a transport ventilator or (2) a Mapleson Bag-Mask hand ventilating circuit. The~     choice of method is largely determined by the preference of the the anesthesiologist who is~     transporting the patient. The investigators postulate that the choice of either method might~     alter respiratory and hemodynamic parameters felt to be important for the immediate~     management of post-cardiac surgery patients. The investigators will prospectively record~     end-tidal carbon dioxide (ETCO2) (primary end-point) and change in minute volume, heart rate~     (HR), Blood pressure (BP), pulmonary artery (PA) pressures and cardiac output during~     transportation and upon arrival in the ICU. All of these variables are measured routinely~     but are not recorded. The investigators will compare patients transported with a ventilator~     to patients transported with a Mapleson circuit.~   "
24226|NCT02740062|"~     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for~     evaluation and treatment of neuropathic pain. The NIBS system evaluates brain neuronal~     network activity and customizes a personalized treatment utilizing low current non invasive~     brain stimulation technology for neuropathic pain with central component. this is single~     meeting trial which includes brain activity evaluation and a single treatment and sham~     treatment. The goal of the study is to evaluate the central brain component of neuropathic~     pain subjects, and the effect of conventional tDCS treatment.~   "
24227|NCT02740049|"~     Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes~     narrow in reaction to something that irritates the airways such as allergens or~     environmental pollutants. There is currently no cure for asthma and new medicines or~     combinations of medicines are needed that will be of benefit to patients particularly those~     with a more severe disease.~      Activation of certain signal molecules inside the lung cells may participate in the~     development of asthma and the response to allergens. Blocking these signal molecules~     specifically with medicines might therefore be beneficial in the treatment of asthma. In~     this study we want to test a new medicine that specifically targets a subset of signal~     molecules that are associated with the allergen response in the lung. In particular, we want~     to test this medicine on cells obtained from the lungs of asthma patients. Understanding the~     effects of this new medicine on these asthmatic lung cells will give vital information on~     how this new medicine works before we can test it in asthma patients.~   "
24228|NCT02740036|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be~     conducted on hard of hearing participants to grant quality control prior to product launch.~     The aim of the investigation series is to ensure zero-defect overall performance of the new~     hearing systems as well as maximum benefit for the participant with the devices in~     comparison to previously outstanding Phonak Hearing Systems and to equivalent competitor~     devices.~   "
24229|NCT02740023|"~     Phonak Hearing Systems pass through different development and study stages. At an early~     stage, feasibility studies are conducted to investigate new algorithms, features and~     functions in an isolated manner.~   "
24230|NCT02740010|"~     The purpose of this observational, non-controlled, multicenter trial with a retrospective~     design is to evaluate the visual performance of one cohort of patients who received the~     multifocal intraocular lenses (MIOL) MINI WELL® following refractive lens exchange (RLE) or~     cataract surgery. Primary outcome were: Uncorrected Distance Visual Acuity, Best Corrected~     Visual Acuity, Best Corrected Near Visual Acuity, onset of halos and glare (during night~     vision). It was also evaluated: Distance-Corrected Contrast sensitivity without glare,~     reading speed with the best correction for distance, and Defocus Curve under photopic~     conditions. ADE/SADE/USADE and AE/SAE were secondary outcomes.~   "
24231|NCT02739997|"~     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and~     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for~     the treatment of Complicated Intra-abdominal Infections (cIAI) in Japanese participants.~     Efficacy will be primarily assessed by clinical response defined as complete resolution or~     significant improvement in signs and symptoms of the index infection.~   "
24232|NCT02739984|"~     The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab~     taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein~     cholesterol (LDL-C) in subjects with type 2 diabetes mellitus and high blood cholesterol on~     a maximally tolerated oral dose of statin of at least moderate-intensity.~   "
24233|NCT02739971|"~     The purpose of this study is to investigate whether dietary intake of pre-formed advanced~     glycation end products (AGEs) modulates brain function measured by MRI) and cognitive~     function measured by a thorough neuropsychological battery. In a 6 months randomized~     parallel study of adults above the age of 65, with mild cognitive impairment (MCI) and type~     2 diabetes. The investigators will compare two groups numbering 60 subjects each. Both~     groups will be advised on a diet appropriate for type 2 diabetes in the elderly by a~     nutritionist. In addition, the intervention group will be instructed on how to cook a~     low-AGE diet , with the aim of achieving a 40-50% lower AGE content, and they will be~     closely followed throughout the study to ensure compliance. Since diet is a modifiable~     lifestyle, diminishing AGEs consumption by cooking in lower temperatures (higher cooking~     temperatures being associated with higher AGE production) may be a simple non-invasive~     intervention which has potential of delaying or preventing cognitive decline which is~     associated with dementia.~   "
24234|NCT02739958|"~     The aim of this prospective, randomized clinical study is to compare between propofol and~     isoflurane on perioperative immune cell populations and function in patients undergoing~     total laryngectomy surgery.~   "
24235|NCT02739945|"~     The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve~     at the elbow after open release or endoscopic release.~   "
24272|NCT02739464|"~     This study will measure efficacy of early in-patient exercise as an adjunct to current~     Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to~     assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10)~     carried out soon after admission until hospital discharge (including during the BICU stay~     and time on ventilation).~   "
25304|NCT02725970|"~     The Dietary Guidelines for Americans provide recommendations for making better food and~     physical activity choices that promote health and help prevent disease. Yet, few Americans~     meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.~   "
24236|NCT02739932|"~     The primary study aims are to determine the clinical, behavioural and social predictors of~     SMI development in youth, and to investigate whether neuroimaging can distinguish youth who~     will develop SMI from those who will not.~      The study's secondary aims are to examine the proportions of the cohort that make~     transitions between the different clinical stages of risk, and to determine the proportions~     that have poor outcomes, defined as ongoing or increased symptoms, secondary substance~     misuse, poor social or role functioning, i.e., non-participation in education, or~     employment, and new self-harm.~      Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes~     youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group;~     n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and~     healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well~     as imaging data will be gathered to create a multi-layered snapshot of these individuals~     and provide full-level characterization. Investigators will use the full range of clinical~     and imaging data generated from this cohort to develop novel prediction algorithms~     incorporating key variables that predict the development of SMI.~   "
24237|NCT02739919|"~     The aim of this research is to use a controlled laboratory setting to determine whether~     bacteria isolated from kidney stones of patients play a role in the formation of~     non-infectious kidney stones. It is well known that struvite stones are associated with~     active bacterial infection, however the role of bacteria in the formation of non-infection~     stones (like calcium oxalate) is not well characterized and there are theories that bacteria~     are involved in the making of these stones.~   "
24238|NCT02739906|"~     This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over~     trial in subjects with type 1 diabetes mellitus.~      Each subject will be administered individualised single subcutaneous doses of BioChaperone~     Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®~     Normal) immediately before ingesting a standardised mixed meal.~      Following trial drug administration, PK and PD assessments will be carried until 6 hours~     after start of the standardized test meal.~      The total trial duration for an individual subject will be up to 11 weeks.~   "
24239|NCT02739893|"~     The aim of this study is to see if use of ScopeGuide, as compared to the traditional~     colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease~     of completion, time to completion, and reduction in the number of mechanical loops and~     external maneuvers required to advance the scope. Other outcome measures include looking at~     the amount of sedation required (independent of weight) and polyp rate detection.~   "
24240|NCT02739880|"~     The main objective of this study is to measure changes in the thickness of the vaginal~     lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.~   "
24241|NCT02739867|"~     Among patients with a first episode of unprovoked venous thromboembolism (VTE), the~     contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these~     cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of~     platelets is a promising, highly accurate biomarker for cancer detection, but its clinical~     utility in patients with unprovoked VTE is unknown. The objective of the present study is to~     evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in~     patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of~     other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.~   "
24242|NCT02739854|"~     The purpose of this study is to identify the prevalence rate and risk factors for pulmonary~     complications in patients with critical trauma who intubated and mechanical ventilation.~   "
24243|NCT02739841|"~     The purpose of this study is to explore acute hemodynamic responses to VHI technique in~     critical traumatic patients with pulmonary complications in the intensive care unit.~   "
24244|NCT02739828|"~     The objective of this study is to assess quality of life (QoL), skin pain, work~     productivity/activity and health related problems in Swedish patients with moderate to~     severe HS before and after 6 months treatment with Adalimumab. The patients will be treated~     in accordance with normal routine clinical care.~   "
24245|NCT02739815|"~     This study aims to define a safe prophylactic intravenous TXA dose with an advantage over~     others in reducing total blood loss volume at secondary uncomplicated LSCS.~   "
24246|NCT02739802|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
24247|NCT02739789|"~     This research study identifies neural pathways regulating negative moods during rejection by~     combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy~     controls.~   "
24248|NCT02739776|"~     The purpose of this study is to describe infrared thermographic imaging as a tool for the~     assessment of epidural block in obstetrics patients~   "
24249|NCT02739763|"~     The investigators wish to understand how resistance to malaria develops and how this affects~     the growth rate of malaria in individuals who have past exposure to malaria.~   "
24250|NCT02739750|"~     Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A~     component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to~     those in the normal population of the same age. It is not clear if there will be changes in~     the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney~     function, thiazolidinedione group of drugs have had variable effects on bone marrow fat~     content, as measured by MRS. This is important as changes in marrow fat are likely related~     to changes in the bone in patients with chronic kidney disease.~   "
24251|NCT02739737|"~     No consensus exists among biomedical journals on the subject of blinding during the peer~     review process. Some journals attempt to remove all identifiers of authorship from potential~     manuscripts before delivering to referees for peer review while others prefer to leave the~     authorship transparent. Although peer review remains the gold standard for manuscript~     evaluation, the lack of a standardized blinding process between editorial offices may be a~     source of publication bias and make comparisons of manuscripts published in different~     journals more difficult to interpret.~      Proponents of a blinded peer review system believe that knowledge of authorship may leave~     referees vulnerable to biases about those authors' previous research, perceived expertise,~     institution, nationality, or gender. This shifts judgment away from the merits of the~     scientific work and introduces pre-conceived notions about the identity and background of~     the author into the review process. Conversely, supporters of transparent authorship argue~     that knowledge of author identity makes it easier for the referee to provide more~     appropriate critiques. Open author identification allows referees to compare the current~     manuscript to previously published work by the author, and to recognize or identify~     potentially important conflicts of interest.~      The investigators therefore propose an experimental study to address the question of whether~     blinding affects the likelihood a reviewer will recommend acceptance of a study being peer~     reviewed. The investigators plan to work in partnership with a journal to have a fabricated~     manuscript peer reviewed by a large number of reviewers; the authors will send this test~     manuscript out either in blinded form (authors' names/institutions not shown to reviewers)~     or in open form, with the names of several well-known, well-regarded authors and their~     institutions visible to peer reviewers. The manuscripts will otherwise be identical.~      The partnering journal, Clinical Orthopaedics and Related Research allows both open and~     blinded peer review, regularly employing both approaches (authors can choose what kind of~     review they prefer when they submit to CORR), and so the reviewers are unlikely to be~     troubled by seeing a manuscript in either format.~      The primary goal of this study is to determine whether the identification of a manuscript~     with a prominent group of authors (open authorship) will affect the likelihood that~     reviewers will recommend the manuscript for publication.~      Additionally, the investigators plan to purposely place several errors in the manuscript,~     and tally how often reviewers detect these mistakes, to determine whether reviewers read the~     work of prominent authors less critically.~      The investigators will also compare the reviewers' grading of the (identical) methods~     section, to determine whether the identification of a manuscript with prominent authors~     results in higher reviewer grades for methodological rigor.~      This study tests the following specific hypotheses:~        1. The visibility of prominent author names and institutions on test manuscripts will be~          associated with increased likelihood that the manuscript will be recommended for~          publication by peer reviewers. (Primary Study Endpoint)~        2. The visibility of prominent author names and institutions will be associated with a~          decreased likelihood that purposefully placed errors in the experimental manuscript~          will be detected by the reviewers.~        3. The visibility of prominent author names and institutions will be associated with~          increased scores given by reviewers for the methods section, despite the fact that the~          methods sections of the experimental manuscript will be identical.~      NOTE:~      All elements of the research protocol were approved by the University of Washington Human~     Subjects Review Committee, including the study's opt-out design for reviewer recruitment,~     since it was considered important that reviewers not know that the paper they evaluated was~     part of a study. To minimize the potential for harm, the authors chose as the topic of the~     fabricated test manuscript an intervention that could not be immediately put into practice~     at reviewers' own centers (a particular team-training process in the operating room). In~     addition, participating reviewers were informed which paper was the test manuscript at the~     completion of data collection, so that they did not pursue this sort of team training based~     on the results of the fabricated study.~      To reduce the risk of an observer (Hawthorne) effect, it was important to minimize the~     likelihood that participant reviewers would learn of the study while it was in progress. To~     this end, the investigators elected not to pre-register the study in a trial registry.~   "
24265|NCT02739555|"~     Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults,~     responsible for intense bone pain, which has a tendency to spontaneously heal with~     mineralization of the nidus, but extremely slowly. This healing may be accelerated in~     patients taking NSAIDs regularly during a few years. The long delay for healing and intense~     pain, explain why patients are quickly directed to surgeons or specialized radiology~     departments for tumor ablation. But percutaneous treatment or surgical excision destruction~     can expose the patient to a substantial risk in terms of neurologic or joint damages,~     depending on the location. Bisphosphonates treatment may be an effective alternative to~     percutaneous treatment by accelerating the natural history of OO.~   "
24252|NCT02739724|"~     Introduction~      Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies.~     Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results~     of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So~     it seems interesting to conduct a new study about this technic. Aim of this study is to~     compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or~     classic laparoscopy (CL).~      Materiel and Methods~      We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years~     requiring laparoscopic surgery for adnexal pathology with stratification for procedure~     (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in~     two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is~     postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and~     perioperative complications, duration of procedure, postoperative quality of life and~     immediate postoperative pain.~      We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic~     scale 0-10). The estimated size of population number is 54 per group and 108 for the study.~      Expected results~      We expected a significant decrease of postoperative pain with SPA technic. This data will be~     interesting to promote use of SPA technic for adnexal surgery.~   "
24253|NCT02739711|"~     Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on~     reperfusion success assessed by cardiac magnetic resonance imaging in patients with~     myocardial infarction and angiographic evidence of no-reflow.~   "
24254|NCT02739698|"~     A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed~     with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical~     surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues~     (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia~     intraperitoneal intraoperative chemotherapy with paclitaxel~   "
24255|NCT02739685|"~     The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting~     bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total~     occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.~   "
24256|NCT02739672|"~     randomized, open-label, single dose, replicate crossover clinical trial to compare the~     pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan,~     amlodipine and hydrochlorothiazide in healthy male volunteers~   "
24257|NCT02739659|"~     The aim of this research project is to assess the feasibility and safety of carbon-ion~     radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer~   "
24258|NCT02739646|"~     Rationale: The representation of the breast on the somatosensory cortex has not been~     precisely located. Therefore, a pilot study with healthy subjects is needed to localize the~     sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.~      Objective: To determine the exact localization of the representation of the sensibility of~     the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess~     whether there are differences in representation between individuals of the same sex and~     between both sexes.~      Study design: A single center pilot study carried out in the Maastricht University Medical~     Center, the Netherlands.~      Study population: A total of 10 female and 10 male healthy individuals will be recruited.~      Intervention: Every subject will undergo a functional MRI scan with stimulators applied to~     the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the~     breast and nipple-areola complex in a random sequence.~      Main study parameters: The hemodynamic response after stimulation of the skin of the breast~     and nipple-areola complex, representing neuronal activity in that region, is measured.~     Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns~     after the various stimulation conditions are assessed, and the representation of the breast~     on the somatosensory cortex is mapped.~   "
24259|NCT02739633|"~     Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and~     Metastatic Adenocarcinoma of the Pancreas.~   "
24260|NCT02739620|"~     Exercise training has beneficial effects in cancer survivors to minimize some of the side~     effects of cancer and its treatment and improve long-term prognosis, but there are numerous~     hurdles for individuals diagnosed with, and being treated for, cancer to participate in~     exercise programs. The goal of this research study is to begin to evaluate whether exercise~     training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal~     muscle size and function in cancer survivors.~   "
24261|NCT02739607|"~     Objectives~        1. To test the effectiveness and acceptability of an augmented internet-supported~          transdiagnostic intervention in Romania.~        2. To assess the cost-effectiveness of the Internet version of the transdiagnostic program~          as compared to a standard treatment/usual care.~   "
24262|NCT02739594|"~     This multicenter, open-label trial will randomize participants with multiple myeloma to a~     regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity,~     measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an~     absolute value of 30 milliliters per minute (mL/min) or lower.~   "
24263|NCT02739581|"~     The patients will be randomized into two groups~        1. Endoscopic Variceal Ligation with Non Selective Beta Blocker~        2. Placebo with Endoscopic Variceal Ligation~   "
24264|NCT02739568|"~     The first objective of this study is to demonstrate the efficacy and safety of pitolisant~     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,~     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea~     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by~     nCPAP but still complaining of EDS.~      The secondary objectives of the study include assessing the long-term tolerance as well as~     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks~     of Open Label Extension period and further investigating the co-variates or co-medications~     that affect the pharmacokinetics of pitolisant in the target population.~   "
24266|NCT02739542|"~     The purpose of this investigation is to systematically study the efficacy of Tecfidera in~     those individuals who possess incidental white matter anomalies within the brain following a~     MRI study that is performed for a reason other than for the evaluation of MS (multiple~     sclerosis).~   "
24267|NCT02739529|"~     Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3~     weeks for gynecologic cancer (adult solid tumor): a phase I trial.~   "
24273|NCT02739451|"~     Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised~     patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a~     nasal cannula or mask [with or without a bag and with or without the Venturi system] to~     achieve SpO2≥95%.~      Oxygen therapy may be combined with non-invasive ventilation [NIV] providing both~     end-expiratory positive pressure and pressure support. However, in a recent trial by our~     group, non-invasive ventialtion [NIV] was not superior over oxygen without NIV.~      High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to~     standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of~     higher flow rates [of up to 60 L/min] via nasal cannula devices, with Fraction of inspired~     oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and~     constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to~     improved breathing-effort efficiency, and higher positive airway pressures associated with~     better lung recruitment.~      Clinical consequences of these physiological benefits include alleviation of dyspnoea and~     discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for~     intubation in patients with severe hypoxemia, and decreased mortality in unselected patients~     with acute hypoxemic respiratory failure However, although preliminary data establish the~     feasibility and safety of this technique, HFNO has never been properly evaluated in~     immunocompromised patients.~      Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard)~     oxygen, minimising day-28 mortality~   "
24274|NCT02739438|"~     The carry out a prospective cohort study of healthy volunteers, assessing differences~     between baseline pulmonary inflammation, response to LPS inhalation and endothelial~     function, as measured by flow mediated dilation between, electronic cigarette uses,~     cigarette smokers and non smokers.~   "
24275|NCT02739425|"~     The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical~     routine practice. On the one hand this allows evaluation of the equivalence of the two~     techniques. On the other hand this ensures that patients do not experience any possible~     disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as~     efficient as conventional sentinel node mapping.~      The programme will compare the Sentimag® with the conventional sentinel lymph node detection~     with radioactive tracer combined with blue dye (in centres using the combined technique) and~     thereby determine whether the new technique is equivalent to the standard technique for~     SLNB.~   "
24276|NCT02739412|"~     A common complication of organ transplantation is 'rejection' of the transplanted organ.~     This occurs when the body's immune system tries to attack (or reject) the transplanted~     organ.~      Drugs known as immunosuppressants (anti-rejection medications) are prescribed for patients~     after transplantation to prevent rejection. But, anti-rejection medications are associated~     with significant side effects including high blood pressure, high blood sugars, and high~     cholesterol - all of which may increase the risk of heart and vascular complications.~     Anti-rejection medications also increase the long-term risk of some types of cancer.~      Sometimes, liver transplant patients who stop taking anti-rejection medications do not~     experience rejection of their transplanted liver and the liver keeps working. These patients~     are said to tolerate the transplanted liver, and this condition is referred to as~     tolerance. Doctors are working to learn more about why some liver transplant patients~     develop tolerance after receiving a transplant, while others do not.~      Studies have shown that patients who develop tolerance have an increase in a type of~     immune cell called regulatory T-cells or Tregs. This means Tregs may be important in~     preventing rejection of a transplanted organ.~      Studies have also shown that a human cytokine (a type of protein), called interleukin-2~     (IL-2) aids in increasing the number of Treg cells in the body, and IL-2 has been given to~     patients to successfully treat disorders of the immune system such as graft vs host disease~     - a serious condition sometimes seen in patients after bone marrow transplantation.~      The purpose of this investigation is to study if low dose IL-2, given to liver transplant~     patients by subcutaneous (under the skin) injections, over a 4 week period of time, will~     cause an increase in the number of Treg cells in the blood.~      In addition, investigators will learn about the kinds of side effects low dose IL-2 will~     cause and how severe those side effects will be.~   "
24277|NCT02739399|"~     In patients under general anesthesia, episodes of hypotension are often treated with~     phenylephrine. The effect of phenylephrine is conventionally attributed to afterload~     increase.~      The aim of the study is to describe the time course of the effects of phenylephrine on the~     cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive~     alpha-mimetic, could be beneficial for preload optimisation.~   "
24278|NCT02739386|"~     The research questions to be addressed by this study are as follows:~        1. What is the prevalence of ipilimumab use among adults with a history of autoimmune~          disease that received treatment with ipilimumab for advanced melanoma?~        2. Do melanoma patients with a history of autoimmune disease experience complications that~          require hospitalization related to their underlying autoimmune disease following~          treatment with ipilimumab?~   "
24279|NCT02739373|"~     The main purpose of this study is to measure the amount of study drug (BMS-986189) in the~     blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after~     a single dose.~   "
24280|NCT02739360|"~     This study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored~     Study GS-US-315-0102 at the time of study closure.~   "
24281|NCT02739347|"~     This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS)~     on cognitive control, working memory, functional, clinical, and cognitive outcomes in~     schizophrenia patients.~   "
24282|NCT02739334|"~     The purpose of this study is to learn whether a combination of two research-proven programs,~     a responsive caregiving parenting program and a childhood obesity prevention program, will~     have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators~     hypothesize that the children participating in the intervention will have significantly~     lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of~     servings of fruits and vegetables, and minutes of physical activity.~   "
24323|NCT02738801|"~     A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory~     phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety,~     tolerability, PK and PD of GLPG1690. Male and female subjects aged 40 years or older will be~     screened to determine eligibility. The screening period will be up to 4 weeks. At baseline,~     eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo~     administered for 12 weeks. The subjects will visit the study center at screening, baseline,~     week 1, 2, 4, 8 and 12 and for a follow up visit 2 weeks after the last administration of~     study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital~     signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/BALF samples,~     Spirometry, St George's respiratory questionnaire, high-resolution computed tomography~     (HRCT).~   "
34274|NCT02608450|"~     The primary objective of this study is to determine the safety and efficacy of CB-03-01~     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial~     acne vulgaris.~   "
24283|NCT02739321|"~     The purpose of the present study is to evaluate the tolerability and efficacy of the Sound~     To Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder~     (ASD). The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality~     in individuals with ASD and sleep disturbance by providing mattress vibrations that~     accompany and sync with auditory stimulation. For the present study, the primary objectives~     are as follows:~      * SA1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected children~     with sleep disturbances is well tolerated as defined by group drop-out proportion due to~     issues with the mattress technology.~      The study will also explore the following objectives:~        -  SA2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep~          quality as measured by parent reported sleep quality in ASD-affected children with~          sleep disturbances. (Please note SA2 was changed from clinician-rated to parent-rated~          because we were not able to collect clinician-rated sleep quality information).~        -  SA3 - To determine the tolerability of the Sound To Sleep System™ as defined by study~          drop-out due to any reason and caregiver ratings of ease of mattress technology use.~        -  SA4 - To determine whether use of the mattress technology improves functioning as~          defined by secondary outcome measures.~   "
24284|NCT02739308|"~     The aim of this study is to investigate the influence of a 12-week proprioceptive training~     program on the neurofunctional control and the incidence of ankle sprains in fencing~     athletes. The study will be developed in six stages: familiarization, pre intervention,~     intervention, post intervention follow-up of three and six months. In the pre intervention~     stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle~     flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge~     Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop~     Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12~     weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of~     three to six months will be held the same pre intervention of the tests and recording the~     incidence of injuries occurred during the study. The expected result at the end of the study~     is to improve all variables, increasing the performance of athletes and decreasing the~     incidence of ankle sprains.~   "
24285|NCT02739295|"~     NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis.~     This is a prospective randomized controlled trial.~      Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of~     G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at~     admission and will be followed until 3 months after discharge.~   "
24286|NCT02739282|"~     The investigators aim at studying therapeutic drug monitoring of newer generation~     antiepileptic drugs (AEDs) in people with epilepsy, using state of the art Ultra-performance~     Liquid Chromatography coupled to Tandem Mass Spectrometry:~        -  to assess the tangible benefit of individualising therapy through therapeutic drug~          monitoring in term of clinical response and adverse events~        -  to assess the reliability and added value of salivary therapeutic drug monitoring This~          will be assessed through a randomised trial of either systematic or rescue therapeutic~          drug monitoring in people requiring treatment adjustment; outcome will be assessed in~          term of tolerance and treatment response in a survival analysis to assess the benefit~          of systematic therapeutic drug monitoring. For each blood samples taken in those~          studies, a saliva probe will be collected and its reliability ascertained~          retrospectively.~   "
24287|NCT02739269|"~     This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis~     for gonadotrophin dosing in in-vitro fertilization treatment.~      The hypothesis is that the use of serum AMH as the criterion for determination of~     gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.~   "
24288|NCT02739256|"~     The primary aim of this study is to determine if normal bladder function (the ability to~     empty the bladder during spontaneous urination) after surgical repair of pelvic organ~     prolapse returns faster in patients who have a retrograde voiding trial the day of surgery~     versus patients who have a retrograde voiding trial on postoperative day one. Half of~     participants will have a voiding trial 4 hours after surgery, while the other half will have~     the voiding trial postoperative day one.~   "
24289|NCT02739243|"~     Background and study aims: Being a caregiver for someone with cancer can be very difficult~     emotionally. For many the patient is a family member or friend, and so this can cause the~     caregiver a great deal of psychological distress. There are currently very few studies~     looking into the effectiveness of psychological treatments for distressed caregivers of~     cancer patients. This study is looking at tailored group therapy program for carers of~     cancer givers. The aim of this study is to find out whether this program can help to lower~     levels of distress in cancer caregivers and help them to better cope with caring for someone~     with the illness.~   "
24290|NCT02739230|"~     The goal of this research project is to evaluate the effectiveness of a novel treatment to~     control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and~     eliminate risks associated with catheters is the use of Exparel injection into the joint at~     the time of surgery.~   "
24291|NCT02739217|"~     This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability,~     and effects on biomarkers of PBI-4050 in subjects with Alström syndrome for a treatment~     duration of 24 weeks.~   "
24292|NCT02739204|"~     The research and development of novel anti-tumor agents in oral cancer is slow, the~     investigation of repositioning use of currently available drugs in clinical, such as a~     selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential~     alternative strategy.~   "
24293|NCT02739191|"~     Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following~     lower extremity orthopedic trauma to prevent infectious complications.~   "
24294|NCT02739178|"~     The study will measure the impact of sanitation access on women and girl's social and~     emotional health, behaviors, and quality of life in rural India before and after a~     sanitation intervention compared to a comparison group that will receive the same~     intervention at a later date.~   "
24295|NCT02739165|"~     The purpose of this study is to assess the efficacy and safety of the intravenous drip~     infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis~     (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group~     comparison study, and to confirm its superiority over placebo with survival rate on Day 90~     as the primary endpoint.~   "
24296|NCT02739152|"~     Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation~     Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately~     treated cases can lead to severe sepsis or septic shock; being characterized by high~     mortality and morbidity.~      Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment~     very difficult in particular on Emergency Department (ED) patients due to their infectious~     illness background and the frequent comorbidities. Also, the severity of the condition may~     not be apparent at initial contact with ED personnel: patients may arrive at ED with mild~     clinical manifestation and rapidly progress to critical illness, or rather at the opposite~     others have benign evolution despite a similar symptoms. In these conditions, the main~     challenge of ED clinicians is differentiating mild infections from life-threatening ones in~     the heavy workload of ED environment Objective of TRIAGE project is to identify and validate~     biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency~     Department.~      Targeted population is adult patients freshly admitted at ED, whom blood samples will serve~     to validate candidate markers.~   "
24297|NCT02739139|"~     The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has~     beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a~     naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase~     inhibitor. Numerous clinical studies have been undertaken to investigate the effects of~     Huperzine A on cognition and have demonstrated benefit to cognition in both individuals~     diagnosed with neurodegenerative diseases as well as performance on academic tasks by~     students. However, to our knowledge, there are no randomized controlled trials evaluating~     the effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to~     assess the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning,~     as compared to placebo, after 45 days of treatment.~        1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change~          in a battery of standardized neuropsychological tests (see attached).~        2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo~          given orally on sleep.~   "
24298|NCT02739126|"~     Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous~     origin is of utmost importance. Due to it's markedly favourable safety profile, a~     bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a~     meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in~     comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success~     rate), is sub-optimal.~      There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe~     (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could~     be advanced more peripherally to obtain a biopsy.~      Therefore identifying what type of USS probe is better for a given PPL will aid in improving~     the diagnostic yield.~      In this study, investigators compare these two types of probes in the ability to diagnose a~     PPL.~      The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS~     arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too~     small to accommodate an aspiration needle)~   "
24299|NCT02739113|"~     Earlier protocol for cultivated oral mucosal epithelial transplantation (COMET) requires~     trypsin/EDTA to isolate epithelial cells from tissue, and uses murine 3T3 cells as feeder~     cells, which results in biosafety concern. This study uses collagenase instead of~     trypsin/EDTA to isolate epithelial cells, and does not use 3T3 cells co-culture, so as to~     make an animal ingredient-free cell culture product. The purpose of the study is to evaluate~     the feasibility of the new protocol of COMET in clinical use.~   "
24300|NCT02739100|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via~     hemodialysate and via two different intravenous routes in adult patients with chronic kidney~     disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose~     study.~   "
24301|NCT02739087|"~     Currently catheters used in heart catheterization procedures are guided throughout the heart~     chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to~     radiation. With this study protocol the investigators will use MRI technology to take~     real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic~     energy; therefore, it does not expose participants to radiation energy.~   "
24302|NCT02739074|"~     Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal~     or gastric) has become a standard technique validated. The rate of high technical and~     clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains~     that validation. However this treatment is done at the cost of a higher median number of~     treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and~     potentially high costs. The constant improvement of therapeutic endoscopy equipment was~     allowed to see the advent of metal prosthesis completely covered by a membrane allowing them~     endoscopic extraction with ease. It has thus been recently developed short prostheses, of~     large diameter (up to 15/16 mm), with broad flange (or stent diabolo) to be considered for~     use in the drainage of digestive peri collections. Few studies respectively determined the~     effectiveness of this type of prosthesis in the drainage of peri digestive collections Under~     echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is~     to evaluate multicenter prospective clinical and technical efficiency of laying completely~     covered stent diabolo in echo endoscopy for the treatment of necrosis of pancreatic~     origin.~   "
24324|NCT02738788|"~     The goal of this study is to track the intraoperative changes that occur in the airways of~     patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal~     surgeries in the prone position, as well as the regression of these changes postoperatively.~     These surgeries are known to cause edema and swelling of the soft tissues of the head and~     neck, temporarily worsening airway anatomy, but there is little data quantifying these~     changes, and no studies have investigated the time course required for the airway to return~     to its baseline after extubation. This would be important clinical information given that~     airway management is always a major concern perioperatively. The investigators will test~     hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and~     at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a~     patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of~     a difficult intubation) based on the visibility of the soft palate, uvula, and faucial~     pillars inside the oral cavity.~   "
24303|NCT02739061|"~     This study intends to explore the pathogenesis of obsessive-compulsive disorder(OCD) by~     using biological technologies such as genetics and imaging, and to evaluate the efficacy of~     group cognitive behavioural therapy in OCD among the Chinese people. We also prepare to~     explore the synergistic effect of the pharmacological treatment combined with group~     cognitive behavioural therapy in OCD, and to find the biological and psychological index~     which can predict curative effect.~      This research includes case control study and randomized controlled single-blind study. At~     baseline, we compare the dimensions of clinical symptoms, genetics and imaging between OCD~     patients and healthy controls. The OCD patients are randomly assigned into pharmacological~     treatment, psychological treatment or pharmacological combined with psychological treatment~     for a 12-week treatment. After a 12-week treatment, the OCD patients will be divided into~     valid and invalid groups according to the results of our randomized controlled study by~     researchers: to our valid group, patients will continue the current treatment, and to the~     invalid psychological or pharmacological treatment group, patients will have a 12-week~     combined treatment. From the baseline, we will have a 9-month follow up for both OCD~     patients and healthy controls.~   "
24304|NCT02739048|"~     1. The overall objective of the study: By evaluating the curative effect of CSAP in~     localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate~     cancer, and the change of state in cellular immunity and humoral immunity before and after~     CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as~     the change of immune status before and after CSAP.~      2. The main content of the study:~        1. Included in the samples are patients in hospitals for CSAP. The sample capacity are~          planned to be 80. The main purpose of the study is to observe the overall survival rate~          , disease free survival rate, the progress time of the PSA biochemical recurrence as~          well as the disease progress time.~        2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T,~          CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after~          cryoablation within 1 month, 3 months and 6 months.~        3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio~          (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the~          activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2~          weeks and 1 month.~        4. Before cryoablation, detect the expression and distribution of Follistatin-Like1~          (FSTL-1), Besides, verify the connection between the number and activation ratio of~          tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on~          the immune response.~   "
24305|NCT02739035|"~     Compare the outcome following manipulation under anesthesia for stiffness in a randomized~     controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time~     of manipulation to a control group receiving manipulation alone.~      Outcomes will include pain, range of motion, as well as subjective outcome scores.~   "
24306|NCT02739022|"~     This is a pilot study designed to test feasibility of a psychotherapeutic intervention for~     the critically ill patients in intensive care units. Intervention is named Early~     Psychological Support for the Critically Ill (EPSCI)~   "
24307|NCT02739009|"~     This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for~     the assessment of safety, tolerability and pharmacokinetics of single ascending doses of~     MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to~     severe atopic dermatitis.~   "
24308|NCT02738996|"~     Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function~     and insulin production in the body. In type-2 diabetic patients, postprandial glucose~     control, lipid control and reduction of insulin resistance are crucial to deter the~     development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and~     cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently,~     diet, exercise and standard oral medicines are used to treat type-2 diabetes. However,~     providing the most effective treatment to control postprandial glucose and lipid; and to~     preserve the pancreatic β cells is challenging because poor metabolic profiles are still~     detected in type-2 diabetic patients. Therefore, understanding the factors influencing the~     poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important~     to tackle this disease.~      In modern society, people are spending most of their waking time in sedentary behaviour,~     which is primarily prolonged sitting. Prolonged sedentary time is associated with increased~     postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of~     prolonged sitting with short light activity break reduces postprandial glucose, triglyceride~     cholesterol and insulin resistance. However, how frequently patients should interrupt~     sitting, potential longer-term effect of short activity break on reduction of postprandial~     glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and~     experiences on the use of technology to decrease sedentary behaviour and improve glycaemic~     control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to~     investigate this to prove the therapeutic role of frequent short activity break in sedentary~     time in the management of type-2 diabetes.~      Primary Research Objective:~        1. To investigate the dose-response effect of frequency/number of light intensity walking~          breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride~          cholesterol level.~        2. To investigate the potential longer-term effect of light intensity walking breaks of~          sitting on glucose control using 24-h glucose data.~      Secondary Research Objectives: The secondary objectives are~        1. To obtain data to inform the development of a future feasibility trial investigating~          the feasibility, compliance, adherence and longer-term effect of different frequencies~          of light intensity walking breaks in sitting time on glycaemic excursions in~          free-living.~        2. To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the~          use of technology to decrease sedentary behaviour and improve glycaemic control, that~          could be used in the feasibility trial~   "
24309|NCT02738983|"~     Concurrent chemoradiotheray is the standard care for patients with locally advanced~     non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor~     tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase~     inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with~     thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study~     is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in~     wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.~   "
24310|NCT02738970|"~     This study involves a two-part design. Part 1 is designed to determine the optimal dose of~     subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in~     comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta~     will be compared using a compilation of pharmacokinetic (PK) parameters such as area under~     the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum~     concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to~     confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK~     assessments.~   "
24311|NCT02738957|"~     Few studies have investigated breastfeeding in twins, and none have addressed the effect of~     antenatal counseling on breastfeeding twins.The purpose of this study is to investigate the~     effect of antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.~   "
24325|NCT02738775|"~     This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in~     patients with relapsing forms of multiple sclerosis~   "
24312|NCT02738944|"~     Background: Community Health Centers care for over 20 million rural, low income and minority~     Americans every year. Patients often have complex mental health problems such as~     Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers~     located in rural areas face substantial challenges to managing these patients due to lack of~     onsite mental health specialists, stigma and poor geographic access to specialty mental~     health services in the community. As a consequence, many rural primary care providers feel~     obligated, yet unprepared, to manage these disorders, and many patients receive inadequate~     treatment and continue to struggle with their symptoms. While integrated care models and~     telepsychiatry referral models are both promising approaches to managing patients with~     complex mental health problems in rural primary care settings, there have been no studies~     comparing which approach is more effective for which types of patients. Objectives: The~     central question examined by this study is whether it is better for offsite mental health~     specialists to support primary care providers' treatment of patients with PTSD and Bipolar~     Disorder through an integrated care model or to use telemedicine technology to facilitate~     referrals to offsite mental health specialists. We hypothesize that patients randomized to~     integrated care will have better outcomes than patients randomized to referral care.~     Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be~     recruited from Community Health Centers in three states (Arkansas, Michigan and Washington)~     and randomized to the integrated care model or the referral model. Patient Outcomes:~     Telephone surveys will be administered to patients at enrollment and at 6 and 12 month~     follow-ups. Telephone surveys will measure access to care, therapeutic alliance with~     providers, patient-centeredness, patient activation, satisfaction with care, appointment~     attendance, medication adherence, self-reported clinical symptoms, medication side-effects,~     health related quality of life, and progress towards life goals. A sub-sample of patients~     will be invited to participate in qualitative interviews to describe their treatment~     experience using their own words. Likewise, primary care providers will be invited to~     participate in qualitative interviews to voice their perspective.~   "
24313|NCT02738931|"~     Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other~     antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1)~     infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by~     many patients and offer the potential for increased patient adherence and consequently a~     reduced likelihood of virological failure and viral resistance.~      The purpose of the present study is to evaluate the relative bioavailability of two~     experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity~     products in healthy adult subjects.~      This study will be conducted as a randomized, open label three-way, crossover design with 6~     treatment sequences in approximately 30 subjects. Each subject will have a screening visit~     within 30 days prior to the first dose of study drug, three treatment periods each with a~     single dose of study drug and a follow-up visit within 7-14 days after the last dose of~     study drug. There will be at least 7 days washout between dosing periods. The total duration~     of participation of a subject in this study will be approximately 9 weeks.~   "
24314|NCT02738918|"~     BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal~     transplant recipient with immunological risk factors such as pre transplant donor-specific~     anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not~     well defined and improving both short and long-term graft outcome remains a challenging~     question. Recent experimental data suggest that Belatacept could induce B cell anergy ,~     induce regulatory B cell and decrease Ig production. These findings are strengthened by the~     results of both phase II and III clinical studies, showing a significant lower incidence of~     DSA in patients treated with Belatacept compared to recipients receiving a conventional~     immunosuppressive regimen with calcineurin inhibitors (CNI).~      Primary objective will be the incidence of clinical and subclinical humoral rejection~     (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and~     patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12),~     level of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12).~     Inclusion period will be of two years. DSA identification and quantitative analysis before~     and after transplantation will be centralized in only one HLA laboratory Unit (Hospital~     Saint Louis) for providing results homogeneity.~      According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral~     Rejection is close to 20% in patients with mild immunological risk defined by the presence~     of DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and~     3000 (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR~     incidence, 91 patients will be included in this study. Results will be compared to a cohort~     matched for age, sex, immunological risk factor (DSA), time of transplant, transplant center~     and grafted with a similar immunosuppressive regimen including CNI instead of Belatacept~   "
24315|NCT02738905|"~     The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide~     (TMAO) levels in patients with end-stage renal disease.~   "
24316|NCT02738892|"~     This prospective non-intervention cohort study will enroll women in the first or early~     second trimester of pregnancy and follow them through delivery and 42 days postpartum.~      Infants will also be followed until 42 days after delivery. Detailed medical and obstetrical~     information will be collected, as well as biological samples, in order to better elucidate~     the biological mechanisms leading to preterm delivery among Zambian women, in an effort to~     identify new strategies for prevention.~   "
24317|NCT02738879|"~     This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants~     with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and~     titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting~     glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that~     after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C~     (A1C) relative to withdrawing sitagliptin.~   "
24318|NCT02738866|"~     This study is being done to look at the role of continuing palbociclib treatment in~     combination with another type of hormonal therapy (fulvestrant) after disease progression of~     palbociclib in combination with an aromatase inhibitor.~   "
24319|NCT02738853|"~     The study objective is to evaluate safety and efficacy of the Medtronic TAVR 2.0 system in~     patients with severe symptomatic aortic stenosis who are considered at high through extreme~     risk for surgical aortic valve replacement~   "
24320|NCT02738840|"~     A post market study evaluating the St Jude medical MR conditional neurostimulation systems.~   "
24321|NCT02738827|"~     Laser treatment of pTa low grade bladder tumours in the outpatient department~      Number of Subjects/Centres Planned: 20 patients will be included in this study. The study~     will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen,~     Denmark.~      Primary Objective: To show that small pTa bladder tumours safely can be removed with diode~     laser in an outpatient department Secondary Objective: To evaluate the patients experience~     with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog~     Scale Score (pain evaluation).~   "
24322|NCT02738814|"~     This study aimed to verify the effects of propofol for treatment on emergence agitation (EA)~     after sevoflurane anesthesia in pediatric strabismus surgery.~   "
24358|NCT02738346|"~     The purpose of this study was to determine prospectively in all patients with SCLC in second~     line therapy that progression-free survival with the expected reintroduction of platinum /~     etoposide is greater progression-free survival in the standard arm (topotecan ) in patients~     who have relapsed at least three months after initial chemotherapy with platinum-etoposide~   "
36287|NCT02582034|"~     The purpose of this study is to determine whether a treatment with Therasphere which is~     optimized is more efficient compared to a standard treatment for patients suffering from~     hepatocellular carcinomas.~   "
24326|NCT02738762|"~     Earlier studies showed a benefit in survival when glutamine was given intravenously and~     these studies lead to recommendations that glutamine should be given to critically ill~     patients. The ESPEN guidelines recommend 0,2-0,4 g/kg/d intravenous glutamine added to~     standard parenteral nutrition .~      Until recently it was not possible to obtain a plasma glutamine level fast enough to~     consider the result for clinical decision making. With the availability of a Point of Care~     (POCT) measurement of plasma glutamine level a measurement can be performed short after the~     collection of blood. This offers the possibility to identify a patient with a low plasma~     glutamine level shortly after admission and use repeated measurements for evaluation of the~     response to supplementation of glutamine.~   "
24327|NCT02738749|"~     Congestive heart failure (CHF) represents a major health care concern in the United States.~     Currently, risk stratification of sudden cardiac death and the need for implantable~     cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left~     ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is~     suboptimal, alternative testing for risk assessment for the development of sudden cardiac~     death in the heart failure population is desirable.~      At the genome level, the investigator has focused on the role of SCN5A gene mutations in~     arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess~     SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk~     populations. This study will determine if SCN5A variant levels are predictive of appropriate~     ICD therapies in patients with a newly implanted ICD.~   "
24328|NCT02738736|"~     Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting~     for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key~     determinant of blood pressure, and reducing sodium intake has emerged as an important target~     for population-based interventions to prevent CVD. However, there is considerable~     uncertainty about the optimal level of sodium intake that is associated with lowest CV risk,~     and whether optimal levels differ for different populations and individuals. International~     and national guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons,~     and advocate a population-wide approach to reducing sodium. Most of the world's population~     (~95%) consume between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most~     people will require a major change to their diet, to achieve the guideline target (<2g/day).~     While there is convincing evidence that high sodium intake (>5g/day) is associated with an~     increased risk of CVD, compared to low or moderate intake, the evidence that low sodium~     intake (<2.0g/day) is associated with a lower risk of CVD than moderate intake (2.0-5g/day)~     is inconsistent and inconclusive. The investigators plan to conduct a Phase IIb clinical~     trial to evaluate the role of low sodium intake (versus moderate) on cardiovascular~     biomarkers.~   "
24329|NCT02738723|"~     As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present,~     the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation~     therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP~     regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung~     cancer~   "
24330|NCT02738710|"~     This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between~     infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy~   "
24331|NCT02738697|"~     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the~     second leading cause of cancer-related death. Surgical resection is still the main radical~     approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the~     further improvement of prognosis of HCC patients. The conventional risk factors of~     recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture.~     Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of~     recurrence after hepatectomy. The investigators' previous study showed that the recurrence~     rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was~     confirmed as the only independent risk factor for the overall and disease-free survival of~     HCC patients in multiple variables analysis. It is important to reduce the recurrence and~     prolong the survival of patients after hepatectomy with effective adjuvant therapy. Reported~     at 2014 American Society of Clinical Oncology (ASCO) annual meeting, A phase III randomized,~     double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to~     prevent recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary~     endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which~     compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX)~     showed significant improvement in OS, objective response rate (ORR) and disease control rate~     (DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators~     design the current prospective randomized clinical trial to evaluate the effect of adjuvant~     chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC~     patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant~     follow-up.~   "
24332|NCT02738684|"~     This project aims to do a small sample exploratory study, to predict EGFR-TKI targeted~     therapy gefitinib' s efficacy in late stage lung adenocarcinoma patients (phase IIIB or IV),~     who have negative tissue EGFR gene mutation, positive plasma free nucleic acid EGFR gene.~   "
24333|NCT02738671|"~     The purpose of this study is to explore the relationship between diabetes and cognitive~     impairment by olfactory function assessment and functional MRI.~   "
24334|NCT02738658|"~     Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with~     metallic stent implantation remain with effort angina despite optimal medical treatment and~     absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina~     after stent implantation is microcirculatory dysfunction. Coronary circulation matches the~     myocardial blood supply and oxygen consumption. Metallic stent implantation has been related~     with endothelial dysfunction and impaired coronary blood flow reserve (relation between~     coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.~      Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and~     to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never~     been tested.~      Main objective: To determine differences in the blood average peak velocity at maximal~     hyperemia with adenosine infusion between patients treated with bioresorbable and metallic~     coronary stents at 1 year after stent implantation.~      Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent~     (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease.~     At 1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor~     drugs. A pressure/Doppler wire is advanced distally to the treated segment and the~     endothelial (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor~     function is assessed with quantitative coronary angiography and pressure and Doppler~     measurements. Angina test questionnaires are obtained at different time-points of the study.~      Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in~     the maximal average peak velocity (APV) under maximal hyperemia (with adenosine~     administration) is expected, as assessed by Doppler measurements, at 1 year after stent~     implantation. The study is powered to assess superiority in terms of maximal APV favoring~     patients treated with BVS.~   "
24359|NCT02738333|"~     This study will evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir~     (LDV/SOF) fixed-dose combination (FDC) and the safety and tolerability of LDV/SOF FDC and~     sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 HCV (hepatitis C~     virus) infection.~   "
24360|NCT02738320|"~     The purpose of this study is to develop a consumer friendly web-based interface between~     Nursing Home Compare (NHC) and an e-coaching/decision-aid tool (NHCPlus) and determine if~     use of NHCPlus facilitates and enhances access to and use of NHC.~   "
24335|NCT02738645|"~     From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of~     respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical~     character has changed quietly, especially severe pneumonia. This cohort study aim to obtain~     the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through~     the clinical data analysis, the investigators could get the information of the pneumonia~     caused by different reasons, such as morbidity and mortality, risk factors, clinical~     symptoms and radiographic changes, the respiratory support parameter and so on. The~     investigators hope the result could guide them do the clinical work of severe pneumonia~     better in the future.~   "
24336|NCT02738632|"~     Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of~     Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with~     Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by~     Telmisartan/Amlodipine Combination~   "
24337|NCT02738619|"~     Vitamin D as adjuvant to subcutaneous specific immunotherapy in patients with allergic~     rhinitis Specific allergen immunotherapy is the treatment of choice for patients with~     persistent allergic rhinitis. Some strategies to accelerate immunological and clinical~     changes to ensure an early response and improve adherence are needed. The administration of~     vitamin D along with conventional treatments in allergic patients with asthma or atopic~     dermatitis, pathophysiological entities like allergic rhinitis, reduces the severity of~     symptoms in less time.~      Primary endpoint. To evaluate the efficacy of vitamin D in terms of reducing the time of~     therapeutic response to subcutaneous specific allergen immunotherapy.~      Compare the time of clinical improvement and adherence to treatment among the group~     receiving vitamin D against the group receiving placebo Analyze the relationship between~     vitamin D values, total serum IgE, serum eosinophil and nasal cytology in both groups before~     and after treatment Assess the safety of vitamin D by serum calcium. TH17 and Treg quantify~     cells before and after treatment. MATERIAL AND METHODS This is a interventional, prospective~     clinical trial randomized placebo-controlled, double-blind study including paediatric~     patients (children 3-12 yr old) with allergic rhinitis, with parallel group: Immunotherapy +~     Placebo and Immunotherapy + Vitamin D. Patients prior informed consent include more patients~     being female and male of 3 to 12 years old. They will be randomized and in the same~     proportion. The sample was calculated using the G Power program to achieve an effect size of~     0.65, with alpha = 0.05, statistical power = 80% and 20% losses to mean difference of 2~     independent groups, the result was 80 patients, 40 per group. Monitoring will be conducted~     at 0, 3 and 6 months, assessing clinical and laboratory parameters with the questionnaire~     RQLQ, TNSS, CARACT KIDS, ARIA, GINA.~      ANALYSIS It will be analyzed in SPSS. The results are expressed by descriptive statistics.~     For comparison of means will be used t student. It will be analyzed with ANOVA, variance for~     repeated measures in time, general linear model, structural equations, multivariate~     analysis, analysis of the main components. P values <0.05 were considered statistically~     significant.~   "
24338|NCT02738606|"~     The goal of this clinical research study is to compare the effect of having liver resection~     with standard of care chemotherapy to having standard of care chemotherapy alone in patients~     whose colorectal cancer has spread to their liver and lungs.~   "
24339|NCT02738593|"~     third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not~     known the specific mechanisms for those non-responders and patients grow resistance.Next~     generation sequencing is current the most sensitive and specific method to exam gene~     mutation, diversion etc.~      By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and~     resistance.~   "
24340|NCT02738580|"~     Serum concentrations of the different hormones involved in follicular steroid genesis during~     a cycle of controlled ovarian stimulation with recombinant FSH or HMG will be compared in~     this study. Serum Progesterone (P) levels at the end of Controlled Ovarian Stimulation (i.e.~     the day of triggering) have been related to cycle outcome, in terms of ongoing pregnancy and~     live birth rates. Large cohort studies show that P levels above a certain threshold are~     associated with poorer cycle outcome. The mechanisms behind P elevation are not well~     understood yet. It has been shown that P levels are positively related to ovarian response~     and to the dose of FSH given during COS. Furthermore, it has been well documented that P~     levels at the end of stimulation are significantly higher when recombinant (r) FSH is used~     for COS when compared to HMG, either in a GnRH agonist long protocol or in a GnRH antagonist~     protocol. Some authors suggest that this finding is explained by the fact that COS with rFSH~     provides a higher oocyte yield than when hMG is given, so the higher P levels observed would~     be explained by the larger number of follicles developed when rFSH is used. On the other~     hand, other authors explain this event by a different follicular esteroidogenesis when HMG~     is used for COS compared to rFSH The hypotheisis behind this assumption is that rFSH~     enhances P synthesis from its precursor pregnenolone in the granulosa cells. This P is~     unable to be further metabolized into androgens because of the lack of 17-20 lyase in the~     human granulosa cells, and therefore is delivered into circulation. On the other hand, when~     HMG is given for COS, the ∆4 pathway is promoted, and pregnenolone will be catabolized in to~     Dehidroepiandrostenodione (DHEA), in the theca cells, and this one to Androstenodione, which~     will be finally aromatized in to estrogens. This mechanism will explain the lower P and~     higher E2 levels observed in HMG cycles in comparison to rFSH cycles.~   "
24341|NCT02738567|"~     The use of vasopressor supplement materials to local anesthetics is commonly used in~     procedures in various fields of dentistry, ENT (ear, nose, and throat), Plastic Surgery,~     Hand surgery and gastroenterology. Epinephrine is used to constrict small blood vessels,~     thus reducing bleeding during a medical procedure, reducing the toxicity by reducing~     systemic absorption of local anesthetic, and prolonging the duration and intensity of neural~     blockage created by the local anesthetic.~      There are descriptions in the literature of cases in which the use of lidocain and~     adrenaline caused adverse cardiac events such as arrhythmias, edema and increase in blood~     pressure during ENT and dentistry procedures. As far as we know there has never been a~     systematic examination of the incidence and severity of arrhythmias during procedures with~     local anesthesia.~      The purpose of the study:~        1. To examine the prevalence and types of arrhythmias in patients undergoing a medical~          procedure performed under local anesthesia~        2. Examine whether adding adrenaline to the local anesthetics affects the incidence of~          arrhythmia Determining the prevalence and types of arrhythmia will help determine the~          need for monitoring and type of monitoring required during procedures under local~          anesthesia.~      The patients:~      500 patients undergoing surgery or a medical procedure in which a local anesthetic is used~     at Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be~     included.~      Methods:~      Patients will undergo the medical procedure prescribed for them, using local anesthesia with~     or without adrenaline, at the discretion of the surgeon, in accordance with the usual~     routine being applied nowadays. The amount and type of anesthesia used will be registered.~     In addition to the routine monitoring that is currently performed (blood pressure cuff and~     non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected~     prior to the beginning of the surgical procedure, until the patient is discharged from the~     recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side~     effects being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary~     resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of~     arrhythmia and the presence of clinical symptoms will be investigated.~   "
24342|NCT02738554|"~     Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse.~     However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05~     IU/mL) show good off-treatment durability after treatment cessation. Through the~     quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be~     before once can achieve successful disease control after treatment cessation.~   "
24343|NCT02738541|"~     The purpose of this study was to determine the anti-calculus effect of dentrifice containing~     5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled~     randomized clinical trial.~   "
24361|NCT02738307|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on global cognitive function.~   "
24362|NCT02738294|"~     The aim of the present study was to assess whether it was necessary to conduct magnifying~     endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps~     biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile,~     the investigators proposed the most cost-effective way to diagnose EGC.~   "
24344|NCT02738528|"~     Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the~     substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as~     tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental~     rehearsal in learning motor skills through mental practice (MP), which associates the~     physical practice to somatosensory imagination to action, causes positive effects in several~     motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus,~     this study aims to report the effects of MP as a tooth brushing training strategy in people~     with Parkinson's disease. This project was approved by the Ethics Committee in Research with~     Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and~     after 8 weeks of brushing through the mental practice training, based on O'Leary's index.~     The sample consisted of 35 people, divided into two groups: Intervention Group consists of~     17 people with Parkinson's, in stages I to III of the disease, who underwent brushing~     orientation associated with PM, and the control group people without the disease, who~     received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and~     post hoc Tukey test considering p <0.05. It was observed that after the intervention was a~     significant improvement of the control dental biofilm.~   "
24345|NCT02738515|"~     The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the~     effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing~     (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo~     gel alone in patients with chronic periodontitis (CP).~   "
24346|NCT02738502|"~     The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as~     treatment simplification (switch) in pretreated pregnant women, associated with neonatal~     prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse~     Transcriptase Inhibitor (NRTIs) .~   "
24347|NCT02738489|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced Melanoma. The primary~     objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II~     doses of SHR-1210 in patients with advanced Melanoma.~   "
24348|NCT02738476|"~     The primary purpose of this investigation is to report the short-term clinical outcomes (2-3~     years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing~     system.~   "
24349|NCT02738463|"~     Intrauterine growth restriction ( IUGR )is defined as fetal growth slower than the normal~     growth potential of a specific fetus because of genetic or environmental factors. Recently~     several studies have highlighted the role of many biomolecules as markers for IUGR.~     Measurement of maternal serum ferritin has also been used as a predictive marker for~     increased risk of IUGR. Iron deficiency has its known deleterious effect in pregnancy but~     iron loading may be associated with oxidative damage to cells and tissues. It has been shown~     in various studies that lower level of transferritin receptor expression in placenta is~     associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by~     placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron~     deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition~     of fetal growth~   "
24350|NCT02738450|"~     The purpose of this study is to test in adults with Down Syndrome the safety, tolerability~     and immunogenicity of a vaccine, ACI-24.~   "
24351|NCT02738437|"~     The aim of this study was to investigate the beneficial effect of bone cement in combination~     with wire cerclage on the stability of the sternum following median sternotomy.~      One half of the patients received only wire cerclage the other both bone cement and wire~     cerclage.~   "
24352|NCT02738424|"~     Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone~     marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in~     normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical~     factors appear to be the cause, but the possible influence of the employed post-processing~     software has never yet been evaluated. The purpose of this study is to determine if there is~     variability in lumbar bone ADC related to the post-processing software.~   "
24353|NCT02738411|"~     The main objective of this research is to study the links between changes in the intestinal~     microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and~     the presence / absence of a TH1 immune status at 36 months of age.~   "
24354|NCT02738398|"~     Prospective study of the effects of image acquisition and reconstruction parameters on~     accuracy of FDG PET/CT mediastinal nodal staging in NSCLC~   "
24355|NCT02738385|"~     Several studies have shown relationship between exercise intensity and improvement~     cardiometabolic health. It has been suggested that high intensity interval training and also~     moderate training generate positive effects on metabolic risk factors. For these reasons, it~     is necessary to clarify which type of training, is more effective to improve cardiometabolic~     health in latinamerican population.~   "
24356|NCT02738372|"~     Background: Shoulder pain is the third most common musculoskeletal condition presenting to~     physicians or physiotherapists ) in primary healthcare after low back and neck pain being a~     significant cause of morbidity and functional disability in both working and general~     population. Despite the large group of individuals seeking for primary care services, about~     50% of patients with shoulder pain still report persistent pain after 12-18 months. As a~     result, socio-economic burdens are considerable due to extensive use of heath care services,~     sickness absence, disability pension, and loss of productivity as well as, patient´s~     suffering.~      Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a~     better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to~     analyze the role of central sensitization in predicting a better and/or poor outcome in~     patients with Chronic shoulder pain.~      Hypothesis:~        1. A high level of physical inactivity, kinesiophobia, fear avoidance and pain~          catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic~          shoulder pain.~        2. The presence of central sensitization will predict a poor outcome in patients with~          chronic shoulder pain.~   "
24357|NCT02738359|"~     Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer~     screening, in first degree relatives of patients with colorectal neoplasia: a prospective~     randomized study.~   "
24363|NCT02738281|"~     The purpose of this study is to advance understanding of the natural history of Rett~     syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including~     CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT including the range~     of clinical involvement and to correlate genotype-phenotype over a broad spectrum of~     phenotypes. While much has been learned about RTT, improvements are required in~     understanding the role of factors such as X chromosome inactivation, genetic background, and~     others including the environment, on the great variability observed even between individuals~     with the same MECP2 mutation. These data will be essential to the development and conduct of~     clinical trials that are anticipated from ongoing studies in animal models for RTT. This~     study will not include clinical trials, but should set the stage for such trials and other~     translational research projects (e.g., development of biomarkers).~   "
24364|NCT02738268|"~     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the~     treated area, also known as radiodermatitis (RD).~      Currently, there is a wide variety of strategies to manage RD, including creams, gels,~     ointments, wound dressings. However, up to now, there is still no comprehensive,~     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a~     promising, non-invasive technique for treating RD. In a recent study conducted in our~     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in~     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was~     the first prospective study investigating the potential of LLLT for RD. In the current~     study, we want to investigate the efficacy of LLLT as a tool for the prevention of~     radiodermatitis in head and neck cancer patients.~   "
24365|NCT02738255|"~     Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and~     obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth~     breathers. Research indicates that nasal breathing not only may improve sleep apnea but it~     also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing~     rate, and improves overall lung volumes. Thus, the investigators will test whether a~     single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth~     breathers.~   "
24366|NCT02738242|"~     The Novus system intended to provide ankle dorsiflexion and knee flexion or extension in~     individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury~     or disease. The primary objective of the study is to evaluate the usability of the Novus~     system among these patients and to gain subjects' feedback regarding the device when used on~     a daily basis.The secondary objective is to obtain information about the performance of the~     system as a gait assistive device and to evaluate the subject's Quality of Life while using~     the system.~   "
24367|NCT02738229|"~     Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of~     this are dehydration, pain and hospitalisation. The objective of this randomized controlled~     trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of~     symptoms associated with acute herpes gingivostomatitis in children. This study will involve~     80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7~     days. The primary outcome measure will be the duration (in days) of feeding and/or drinking~     difficulties.~   "
24368|NCT02738216|"~     This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning~     them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a~     series of educational workshops focused on perinatal health, the Mom and Baby Wellness~     Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor~     all participants in the study for safety and clinical deterioration, and measure a variety~     of symptom outcomes over the course of the intervention period during pregnancy, as well as~     at a postpartum follow-up.~   "
24369|NCT02738203|"~     For both intrauterine device (IUD) insertion and endometrial biopsies (EMB) currently there~     are no standardized clinical guidelines for pain management. The investigators aim to~     explore whether adequate pain relief is possible through self-administered, non-invasive~     means alone. Reducing pain associated with IUD insertion and/or EMB may benefit patients and~     providers. When patients are comfortable during their procedure, it is likely the provider~     can more quickly and with fewer complications perform the insertion and/or EMB. The~     investigators propose to explore the effect of a locally applied vaginal lidocaine gel in~     place of the standard of care pain management, no intervention, prior to IUD insertions, and~     EMB.~      They hypothesize that lidocaine gel is superior to placebo at decreasing procedural pain at~     a variety of time points throughout the procedure. This is a superiority, blinded,~     randomized controlled trial.~   "
24370|NCT02738190|"~     This is a randomized controlled trial that compares two different priming composition~     (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under~     10 kg of weight. The two approaches are both employed at the moment but there is actually no~     evidence on the superiority of one over the other. This study is aimed to test the~     hypothesis that Albumin is superior to fresh frozen plasma in terms of minor bleeding and~     transfusional requirements.~   "
24371|NCT02738177|"~     Ninety healthy pregnant women candidate for surgical evacuation after confirming 1st~     trimester pregnancy loss were enrolled in the study. They were randomized in three groups;~     misoprostol group in which 30 candidates were receive 2 tablets of misoprostol (i.e. 400 ug)~     4 hrs prior to surgical evacuation, Effox group in which 30 candidates were received 2~     tablets of Effox (i.e 40 mg) 4 hrs prior to surgical evacuation & combination therapy group~     in which 30 candidates were received 1 tablets of misoprostol 200ug & 1 tablets of Effox 20~     mg 4 hrs prior to surgical evacuation. For all participants, the route of administration was~     the intravaginal route 1ry outcomes included cervical consistency & dilatation immediately~     before the procedure. 2ry outcomes included total duration of the operation and the~     occurrence of drug-related side effects~   "
24372|NCT02738164|"~     Investigators aim to evaluate the SEPSIS 3 criterion for sepsis and septic shock in a~     prospective manner.~      Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population~     of emergency patients with infection~   "
24543|NCT02735902|"~     The main objective of this study is to demonstrate that a single anticoagulant therapy is~     superior to a combination of anticoagulant and antiplatelet therapy on the net clinical~     benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI)~     according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other~     complications; Kappetein et al 2012)..~   "
24373|NCT02738151|"~     Primary Objective:~      To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated~     hemoglobin (HbA1c) change.~      Secondary Objectives:~        -  To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® on:~        -  Change in Fasting plasma glucose (FPG);~        -  Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point~          SMPG profile;~        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5%;~        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5% without severe and/or~          confirmed hypoglycemia~        -  Percentage of patients requiring rescue therapy.~        -  To assess the frequency of occurrence and diurnal distribution of hypoglycemia by~          American Diabetes Association (ADA) category of hypoglycemia.~        -  To assess the safety in each treatment group.~        -  To assess the treatment effects in each treatment group on Patient Reported Outcomes~          (PRO).~   "
24374|NCT02738138|"~     The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults~     with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1~     co-infection.~   "
24375|NCT02738125|"~     This study assesses the long‐term effectiveness of adalimumab in subjects starting a~     treatment for ulcerative colitis in real life conditions, namely to describe the time to~     loss of clinical benefit in a time to event approach.~   "
24376|NCT02738112|"~     Hyo-mandibular suspension has been previously studied as a treatment for obstructive sleep~     apnea (OSA) and has shown to be highly effective.~      This is a prospective, multi-center, registry during which 30 subjects with OSA will be~     considered for hyo-mandubular suspension treatment. After obtaining informed consent and~     meeting all inclusions and exclusion criteria, subjects will be treated using the Encore~     System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1)~     month, three (3) months, and twelve (12) months.~      This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea~     index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional~     outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study~     will evaluate the effect that the change in hyoid position has on the airway anatomy.~   "
24377|NCT02738099|"~     Method: Single center, prospective, non-randomized, unblinded case series of all patients~     presenting with a cardiac arrest. The proposed study will collect data on all comatose~     patients presenting with cardiac arrest. The primary end point is death from any cause at 30~     days from admission.~      Significance: Develop criteria to guide an invasive strategy for comatose patients~     presenting with cardiac arrest, and so avoid ineffective or even futile therapy which carry~     its own significant risks for patients in the future. The criteria, in turn, can serve as~     the basis for a prospective, randomized trial in the future.~   "
24378|NCT02738086|"~     This pilot study will use mobile-health technology to deliver an intervention designed for~     lasting physical activity behavior change. The study will assess the feasibility of using~     the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb~     amputation. This intervention will be delivered using wrist-worn wearable activity sensors~     and a home-based tablet computer to allow real-time physical activity feedback and video~     interface between the participants and the therapist.~   "
24379|NCT02738073|"~     Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen~     to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has~     been shown effective in decreasing blood loss both intra-operatively and in the immediate~     post-operative period in elective hip and knee arthroplasty patients. Both the timing and~     dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has~     also been shown to decrease as result of TA administration. Despite the support for TA~     utilization that exists in the arthroplasty literature, the data is scarce regarding its~     administration during surgical treatment of hip fractures. This is patient population who is~     at high risk for transfusion due to symptomatic post-operative anemia. This study aims to~     investigate whether TA's advantageous effects in the arthroplasty patient population can be~     extrapolated to the more unstable, heterogeneous hip fracture patient population. If the~     study is able to show a difference in blood loss and transfusion requirement, the long term~     implications of this with regards to cost and mortality can be significant.~   "
24380|NCT02738060|"~     To investigate the effect of baked milk in immunotherapy of cow's milk allergy.~   "
24381|NCT02738047|"~     Pharmocogenomic test assessment in the medication regimen and disease management for~     patients under drugs known with genetic variation.~   "
24382|NCT02738034|"~     Systemic arterial hypertension is a disease with high prevalence in several countries,~     including Brazil. Many studies have correlated hypertension with accelerated loss of~     cognitive function, especially executive functions. There is some evidence that working~     memory (WM) is compromised in these populations. However, some computerized training has~     been developed to rehabilitate the WM, and among them the investigators highlight the~     Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the~     performance of WM and attention of hypertensive patients, as well as the impact of training~     in the structure and brain function.~   "
24394|NCT02737878|"~     Dementia is one of the most pressing health care issues of the 21st century. Evidence~     suggests that exercise enhances cognitive function in healthy older adults. Most research~     has focused on aerobic training (AT). Therefore, investigators aim to assess the individual~     effects of AT and resistance training (RT), as well as the interaction effect of combining~     the two types of exercise training, on cognitive function in older adults with mild~     cognitive impairment.~   "
24395|NCT02737865|"~     Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It~     usually shows hypervascular mass on imaging studies and it is not easy to differentiate with~     other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography~     (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH.~     However, temporal window of vascular phase using contrast-enhanced US (CEUS) is very short~     (about 10 sec) and coordination of patient`s respiration during US exam is absolutely~     needed. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan)~     for detection of 'spoke-wheel sign' in patients with proven FNH, which enable to detect slow~     micro vascular flow without using CEUS.~      First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid~     (Perfluorobutane, GE healthcare) and SMI.~      Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference~     standard: CEUS using sonazoid.)~   "
24383|NCT02738021|"~     A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care~     settings will be used to (1) understand context for implementation feasibility (2) evaluate~     benefits for mother and child.~      The proposed pilot project will be conducted as part of a quality improvement effort in the~     Department of Pediatrics at Gouverneur Health Services to improve management of postpartum~     depression during pediatric primary care visits. This project will test the feasibility of a~     stepped care approach to identifying and managing depression among mothers of infants (0-6~     months). This study will provide preliminary data on the feasibility of the care management~     protocol, implementation and fidelity measures, and training/consultation methods within a~     real world pediatric care practice. These data will inform and support the preparation of a~     large-scale NIH grant.~      Specific research questions include:~        1. To pilot the feasibility of using a Stepped Care Approach to identify and mange~          maternal depression within primary care pediatric care visits, with a focus on mothers~          of infants 0-6 months.~             1. Train non specialty MH providers to systematically identify maternal depression.~             2. Assess how effective integration of maternal depression intervention is as part of~               well baby visits.~        2. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention,~          on maternal and child health outcomes (e.g., maternal depression symptoms, child~          receipt of acute care services). Secondary outcomes include maternal social support and~          parenting practices.~   "
24384|NCT02738008|"~     Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be~     evaluated for safety and efficacy.~   "
24385|NCT02737995|"~     Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative~     capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients,~     but the relationship to exercise intolerance and mitochondrial oxidative capacity is~     unknown. This is a pilot study to determine the feasibility of the use of specialized~     31P-MRS and MRI techniques for measurement of skeletal muscle bioenergetics in patients with~     heart failure with and without functional iron deficiency.~   "
24386|NCT02737982|"~     The application of sex-gender medicine is strongly recommended by World Health Organization~     and other international organization. In fact, it is emerging that, although men and women~     are affected to the same cardiovascular diseases (CVD), however they have different risk~     factors, disease progression and response to pharmacological and not-pharmacological~     treatments. Consequentially, the identification of biomarkers and therapeutic approaches~     taking into account sex gender differences (SGD) is relevant to develop a really~     evidence-based medicine.~      With the aim of translate in clinical setting the more recently available basic research~     evidences on estrogens and androgens balance involvement in modulation of~     ischemia-reperfusion myocardial damage, the investigators planned to conduct a research~     study on patients, affected by suspected or known ischemic heart disease (IHD) undergoing~     angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of~     both sex in ratio 1:1. Thus, in this setting, the goals of this proposal are:~        1. To assess the sex-gender difference in entity of microvascular reperfusion damage in~          patients with IHD undergoing urgent or elective PCI;~        2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related~          differences on myocardial ischemia reperfusion damage occurring during PCI;~        3. To investigate the differences in terms of platelet biology between men and women~          affected by IHD undergoing urgent or elective PCI, matched for age and clinical~          cardiovascular and metabolic characteristics;~        4. To verify sex-driven interplay between response to PCI procedure, platelet function,~          sex hormones and entity of reperfusion and myocardial damage, as well as, the impact on~          clinical outcomes during a 1-year follow up.~      This research study wants to explore and consequently elucidate biological mechanisms~     responsible for sex-based differences in vivo human models of ischemia reperfusion~     myocardial damage. Moreover, the investigators expected to clarify the impact of biological~     variables evaluated on clinical outcomes after reperfusion therapeutic intervention.~   "
24387|NCT02737969|"~     This is a pilot study of patients undergoing structural heart disease procedures that~     utilize TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical~     Center. Patients in this study will undergo their procedure utilizing the TEE/Angio fusion~     software prototype. This protocol is primarily intended to ascertain the potential utility~     of the software prototype in the study population and to provide data and feedback to~     improve the workflow and algorithms of the prototype. As such, a primary outcome variable~     and statistical analysis plan have not been identified. However, procedural time, measures~     of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of~     residual valvular regurgitation or paravalvular regurgitation as applicable, and~     complications will be recorded.~   "
24388|NCT02737956|"~     This study is to build a Xinjiang people registry and surveillance system for acute~     myocardial infarction(AMI) in2012-2015years to obtain real-world information about patient's~     basic information, patient characteristics, diagnostic test mode, the program of treatment~     and hospitalization outcomes including mortality, treatment complications, the cost of~     hospitalization and follow-up terminal events (death, major adverse cardiac events, minor~     adverse cardiovascular events)of xinjiang AMI patients; And to propose scientific precaution~     strategies aimed to prevent effectively from the incidence of AMI; And to optimize the~     management and outcomes of AMI patients through implementation of guideline recommendations~     in clinical practice, and analysis and development of effective treatment strategies; And to~     create cost-effective assessment system.~   "
24389|NCT02737943|"~     40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University~     Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment~     (MEBO).~      Intervention:~      Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the~     healing speed and re-epithelization process of skin graft donor and recipient sites.~     Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections,~     rate of complications, total treatment costs and its effect on improving pain alleviation.~      Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of~     operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics &~     analgesics) Estimated Time to Complete 5 months~   "
24390|NCT02737930|"~     The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake~     inhibitor commonly used for depression, enhances visual recovery after an acute ischemic~     stroke.~   "
24391|NCT02737917|"~     To determine the impact, if any the application of oxygen during the apnea period of rapid~     sequence intubation has on patients being intubated in the emergency department.~   "
24392|NCT02737904|"~     This randomised controlled trial aims to explore the effectiveness of a four week programme~     of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of~     spasticity in people with moderate to severe Multiple Sclerosis.~   "
24393|NCT02737891|"~     Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2~     Diabetes Mellitus~   "
24396|NCT02737839|"~     Chronic disease self-management is the ability of the individual, in conjunction with~     family, community and healthcare professionals to manage symptoms, treatments, lifestyle~     changes and psychosocial, cultural and spiritual consequences associated with a chronic~     condition. Self-management strategies have been successfully used in supportive care and~     survivorship in oncology. Stepping On, a multi-component program using a small-group~     learning environment, reduces falls by 31%. It empowers participants with knowledge about~     fall-risk, exercise, medications and environmental hazards to self-manage their risk of~     falls over 7 weeks of educational sessions, followed by a home visit. The research in this~     proposal will yield the adaptation of the effective group-education-based fall-prevention~     intervention Stepping On, tailored to cancer patients, feasible for testing in a~     multi-institutional trial, and ultimately scalable in the oncology setting.~   "
24397|NCT02737826|"~     Chronic opioid therapy for pain can be associated with significant risks, and a significant~     number of patients maintained on chronic opioids have continued pain and/or poor~     functioning. When patients need to or want to come off their opioid pain medications, there~     is little to guide physicians as to how to best help them do so, and it is not known how~     patients do after coming off opioid medications. The goals of this study are (1) to evaluate~     two medications in assisting patients in coming off their opioid pain medications and (2)~     determining outcomes after discontinuing opioids.~   "
24398|NCT02737813|"~     Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect~     the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric~     bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had~     higher cardiac output than those who received phenylephrine~   "
24399|NCT02737800|"~     Investigators compare ICSI results for endometrioma patients with or without cyst aspiration~     if more than 5cm &with or without GnRh agonists for all endometrioma patients~   "
24400|NCT02737787|"~     The purpose of this study is to test the safety of a combination of an investigational WT1~     vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and~     nivolumab are being used in combination.~   "
24401|NCT02737774|"~     This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety~     of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR~     mutation.~   "
24402|NCT02737761|"~     The purpose of the study is to understand how positive emotions (e.g., optimism, happiness)~     are associated with health behavior adherence in patients with heart failure (HF), as well~     as whether performing exercises to improve positive emotions may help to improve health~     behavior adherence as well.~   "
24403|NCT02737748|"~     Primary objective:~        1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)~          for Phase I in terms of Incidence of treatment-related AEs and SAEs (including~          infections and bleeding)~        2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor~          site wounds (DSW) in terms of The healing time from DSW creation to 100%~          re-epithelialization~      Secondary objective:~        1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds~          (DSW) in secondary efficacy endpoints~        2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)~          in secondary safety endpoints~   "
24404|NCT02737735|"~     To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor~     treatment of Chinese Herbs based on syndrome differentiation~   "
24405|NCT02737722|"~     Phase I/IIa, three cohort ascending dose with two dosing arms per cohort, study in Type I or~     II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a~     DUSS score of 0 to 3 and DFI wound score of 1 to 6.~   "
24406|NCT02737709|"~     By detecting the blood concentration of paclitaxel (PTX), Investigator assume this research~     can identify the individual differences of PTX pharmacokinetics (PK) parameters (TC>0.05~     refers to the duration of paclitaxel plasma concentration above 0.05 µmol/L) in Chinese~     non-small cell lung cancer (NSCLC) patients, and find the correlation between PK results and~     PTX toxicities and Effectiveness, acquire the optimization method of PTX, and finally try to~     explore the individualized PTX pharmacokinetically-guided dosing strategy. Orally administer~     rosiglitazone, which is a substrate of CYP2C8 the same as paclitaxel, before chemotherapy~     injection. Detect the blood concentration of rosiglitazone, analyze the correlation of~     rosiglitazone pharmacokinetic parameter and paclitaxel exposure, and explore the effect of~     rosiglitazone as an in vivo probe of paclitaxel exposure.~        1. The variability of paclitaxel concentrations in the patient population dosed by body~          surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.~        2. Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological~          toxicity and clinical outcomes.~        3. Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its~          effect on both reducing toxicity and improving Effectiveness.~        4. The effect of using dose modification and administration of G-CSF based on toxicity~          determined by paclitaxel TC>0.05 measurement.~        5. Construct a trial outline with the aim of reducing grade 4 neutropenia toxicity and~          ensuring the clinical outcome by using individual dose adjustments based on the dosing~          algorithm.~        6. Detect the blood concentration of rosiglitazone after orally administration, explore~          the effect of rosiglitazone as an in vivo probe of paclitaxel exposure based on CYP2C8~          activity. Attempt to establish a model to predict the paclitaxel exposure of patients~          base on rosiglitazone blood concentration before chemotherapy.~   "
24407|NCT02737696|"~     The investigators are developing an interactive, web-based program for youth ages 12-17~     focused on the prevention of prescription opioid abuse because to the investigators~     knowledge, no science-based, interactive program focused on the prevention of prescription~     opioid abuse among youth exists. This program is grounded in a scientific understanding of~     risk factors for prescription opioid abuse among youth, employs informational technologies~     which are effective in promoting relevant knowledge and skills, and presents program content~     using strategies shown to be highly appealing to adolescents. In the completed Phase 1 of~     this project, the investigators developed and demonstrated the scientific, technical and~     commercial merit and feasibility of a prototype of a web-based, prescription opioid abuse~     prevention program for youth. In Phase 2, the investigators will complete the development of~     all components of the multimedia, prescription opioid abuse prevention program and conduct a~     randomized, controlled trial with youth to evaluate the effectiveness of the web-based~     prevention intervention in increasing knowledge about key issues relevant to prescription~     opioid abuse among youth, skills acquisition relevant to preventing their misuse, negative~     attitudes about prescription opioid misuse, and perceived risk associated with their misuse.~     The investigators will also assess the program's effectiveness in reducing intentions to~     misuse prescription opioids as well as actual rates of such use. If this tool is shown to be~     effective, the investigators plan to embed it in a suite of science-based,~     technology-delivered tools focused on the prevention and treatment of substance use~     disorders that have been developed and deployed in a wide array of settings by the~     investigative team.~   "
24408|NCT02737683|"~     Patients with indigestion were often found in gastroenterology clinic, those who about 20 %~     was caused by organic, while the rest of patients are showed abnormal inspection, and these~     are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated~     occurrence of digestive disorders, patients often visit hospitals frequently and unable to~     get fully cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic~     criteria. Although functional dyspepsia condition should combine with physical and mental~     treatments, due to the reasons behind the complex, there is still no effective~     classification could be acted in health education and drug intervention.~   "
24409|NCT02737670|"~     The objective of this prospective randomized and double blind controlled study is to~     evaluate the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic~     idiopathic subjective tinnitus.~   "
24410|NCT02737657|"~     The primary purpose of this study is to describe the tolerability of canagliflozin and any~     sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms~     of the percentage of patients with at least one episode of hypoglycaemia, in patients with~     T2DM who fast during Ramadan.~   "
24411|NCT02737644|"~     The study is a nested case-control study and the purpose is to describe the status of key~     nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to~     find out the association between the level of serum key nutrients during peri-conceptional~     period and the incidence of congenital heart defects (CHD) in newborn, and to provide better~     preconception care.~   "
24412|NCT02736578|"~     This phase I/II trial studies the side effects and best dose of cetuximab-IRDye 800CW when~     used with intraoperative imaging and to see how well they work in finding pancreatic cancer~     in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify~     cancer in the operating room by making the cancer visible when viewed through a special~     imaging device.~   "
24413|NCT02736565|"~     Ewing's sarcoma characterized by the t(11; 22) (q24; q12) translocation at several but~     prioritized breakpoint sites, resulting in the EWS/FLI1 fusion gene is the second most~     frequently diagnosed primary malignant bone tumor in the US with an annual incidence, from~     birth to age 20, of 2.9 cases per million population. The survival rate for patients with~     high-risk recurrent disease (relapse < 2 years) is < 10% at 5 years. Moreover, of patients~     who progress after second line treatment, eighty percent do not achieve a second complete~     response and of these patients < 10% survive one year. Refractory patients to both frontline~     and second line therapy have even worse prognosis.~      The EWS/FLI1 gene is well known as the driver gene of Ewing's sarcoma. We designed a novel~     pbi-shRNA™ EWS/FLI1 Type 1 LPX which has demonstrated sufficient specificity, safety and~     efficacy in animal testing to justify Phase I testing. Clinical safety (no ≥ grade 3 product~     related toxic effect) and target specific activity has been observed with other bi-shRNA~     products involving 147 cancer patients (698 separate dose administrations) (BB-IND 14205;~     BB-IND 14938). Moreover, safety has been observed with IV delivery of pbi-shRNA™ EWS/FLI1~     Type 1 LPX in murine and swine testing via multidose IV administration.~      Study testing of pbi-shRNA™ EWS/FLI1 Type 1 LPX will involve patients (≥age 8) with advanced~     Ewing's sarcoma. The first 3 subjects enrolled onto the study as well as the first subject~     enrolled into each dose cohort must be 16 years of age or older. pbi-shRNA™ EWS/FLI1 Type 1~     LPX will be given via intravenous infusion twice a week for 4 weeks (e.g. Mon and Thurs,~     preferred) for a total of 8 infusions of the product per cycle followed by a 2 week washout~     period. Patients will be accrued in 3-patient dose escalation cohorts using the following~     escalation schema (50% to 33% to 25% to 25% to 25%) at a starting IV dose of 0.04 mg/kg.~   "
24414|NCT02737605|"~     The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and~     electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine~     (intranasal administration) and supratherapeutic exposures of esketamine (intravenous~     administration) in healthy adults.~   "
24415|NCT02737592|"~     To evaluate the safety of a personal lubricant when used at least four times weekly for two~     weeks (including at least twice weekly during sexual intercourse for subjects with~     monogamous male partners), in a population consisting of healthy females.~   "
24416|NCT02737579|"~     This study will evaluate the use of x-ray fused with MR images as an imaging tool to help~     guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.~   "
24417|NCT02737566|"~     The primary objectives of this study are 1) to evaluate the longer-term impact of an~     adjunctive, low-cost financial incentives intervention (relative to standard care) on~     smoking abstinence rates among socioeconomically disadvantaged individuals participating in~     a clinic-based smoking cessation program and 2) to identify treatment mechanisms and~     contextual factors associated with cessation outcomes among intervention participants using~     both traditional and ecological momentary assessment approaches. Those randomized to the~     financial incentives intervention will have the opportunity to earn small gift cards for~     biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that~     individuals who are randomly assigned to the adjunctive CM intervention will have~     significantly higher rates of biochemically-verified abstinence at the 26-week post-quit~     follow-up than those assigned to Usual Care. In addition, we hypothesize that several~     factors related to socioeconomic disadvantage will be directly associated with~     non-abstinence, especially greater stress/adversity, limited psychosocial resources, greater~     negative affect, greater nicotine dependence, and poorer treatment adherence. The primary~     study endpoints will include self-reported tobacco use/abstinence, expired carbon monoxide~     (CO) levels (i.e., the amount of carbon monoxide present in an individual's breath when they~     breathe out), and saliva cotinine levels at 26 weeks post-quit attempt, though smoking~     status will be assessed at all visits. Traditional questionnaire measurement and ecological~     momentary assessment (EMA) will be utilized to measure potential treatment mechanisms~     including motivation, self-efficacy, and treatment adherence. Other variables including~     stress/adversity, psychosocial resources, negative affect, nicotine dependence, and~     treatment adherence will also be assessed.~   "
24418|NCT02737553|"~     Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic~     surgery. For this reason, electromechanical morcellation has long been used to facilitate~     the tissue removal in gynecology. However, electromechanical morcellation has long been~     performed inside the abdomen without any containment. Therefore, this practice has recently~     undergone increased scrutiny because of important concerns related to tissue dissemination~     during intracorporeal power morcellation. Thus, the US Food and Drug Administration released~     a safety communication discouraging power morcellation in laparoscopic hysterectomy and~     myomectomy procedures in April 2014.~      As a result of this serious concern, the enclosed laparoscopic power morcellation has been~     come into prominence in gynecological surgery. Besides the removal of the tissues through~     vagina with posterior colpotomy is considered an another solution for this critical problem.~      In the literature the comparison for the two techniques for tissue removal is considerably~     scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic~     enclosed electromechanical morcellation and tissue removal thorough vagina with posterior~     colpotomy according to surgical time, postoperative pain and postoperative sexual function.~   "
24779|NCT02732834|"~     The purpose of this study is to better understand communication between patients with lung~     cancer and their doctors. The investigators are also interested in patient's perceptions of~     the quality of communication with his/her doctor and how these perceptions may impact~     patient outcomes. The doctor is participating in this study and has given us permission to~     approach his/her eligible patients for study participation.~   "
24419|NCT02737540|"~     The main objective of this study is to confirm the existence of risky decision making in a~     non strategic situation (Iowa Gambling Task) and a deficit of decision making in social~     situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of~     trust (Trust Game) in elderly depressed patients with a history of suicide attempts in~     comparison with older depressed patients without a history of suicidal acts and healthy~     subjects.~   "
24420|NCT02737527|"~     This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar~     sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results~     in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy~     and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates~     to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to~     sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and~     voluntarily sign the informed consent will be enrolled.~   "
24421|NCT02737514|"~     Interval (missed) cancers and lower than expected mortality reduction of proximal colon~     cancers in the United States and elsewhere after screening colonoscopy drew attention to~     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be~     contributing factors. An independent predictor of the risk of interval cancers is adenoma~     detection rate. In pilot observations, the investigators showed that water exchange enhanced~     adenoma detection in the right colon (cecum to hepatic flexure). This prospective,~     randomized controlled trial will compare water exchange with water immersion and traditional~     air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis~     that compared with air insufflation and water immersion, water exchange produces a~     significantly higher adenoma detection rate in the right colon~   "
24422|NCT02737501|"~     A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in~     ALK-positive Advanced Lung Cancer Patients~   "
24423|NCT02737488|"~     The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy~     (TST) decreases children's mental health symptoms (such as acting out, not controlling their~     emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events~     can include experiencing or witnessing violence, excessive bullying, war, car accident,~     serious injury, getting mistreated or anything else that makes one feel scared or~     frightened. Children/teens who experience traumatic events have been shown to be at higher~     risk of poor mental and physical health. Trauma can impact family life, school life and~     interpersonal relationships well into adulthood. Unfortunately, most children who have~     experienced traumatic events do not undergo treatment. Although promising treatments do~     exist, most do not address the complexity of trauma, particularly related to ongoing stress~     and threats to safety in their environments. One hundred and twenty eligible youth will be~     randomized to receive either treatment with TST at NYU's Child Study Center or trauma~     treatment as usual (TAU) at a community mental health clinic.~      It is hypothesized that:~        -  Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress~          Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to~          youth receiving treatment as usual (TAU) in the community.~        -  Youth receiving TST will demonstrate a greater decrease in symptoms of depression,~          anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.)~          at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU.~        -  Youth receiving TST will have fewer acute mental health service events, such as~          psychiatric hospitalizations and ED visits compared to youth receiving TAU.~        -  Greater fidelity to the TST model is associated with better treatment outcomes among~          youth receiving TST.~   "
24424|NCT02737475|"~     The purpose of the study is to determine safety, tolerability, pharmacokinetics,~     pharmacodynamics and preliminary anti tumor activity of BMS-986178 when administered alone~     or in combination with Nivolumab or Ipilimumab in subjects with advanced solid tumors.~   "
24425|NCT02737462|"~     <Part I - Phase I trial> The phase I clinical trial is to identify the MTD (Maximum~     Tolerated Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA. Initial dose of CG200745~     PPA is 150 mg/m^2, and it will be extended to 225 mg/m^2, 300 mg/m^2 or it will be reduced~     to 75 mg/m^2 based on the results of the cohort of 3 subjects per dose level.~      Based on the 3+3 dose escalation study design, CG200745 PPA is to be administered as in four~     different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects.~      <Part II - Phase II trial> In the phase II clinical trial, the subjects will be administered~     with the dose which is to be identified as a recommended dose based on the results of Phase~     I study. The whole one cycle is consisted of 28 days, same as the phase I. The entire~     treatment period is 6 cycles and tumor assessment is evaluated every 2 cycles.~   "
24426|NCT02737449|"~     The primary objective is to prospectively study the comparative effectiveness and~     comparative safety of approved therapies for RA in a Japanese cohort of patients treated by~     rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of~     disease modifying anti-rheumatic drugs (DMARDs); e.g. higher dose methotrexate (MTX),~     non-tumor necrosis factor (TNF) biologics, and Janus Kinase (JAK) inhibitors) will be~     compared with anti-TNF biologics.~   "
24427|NCT02737436|"~     The investigators plan to conduct functional MRI scanning with a group of mothers who are~     blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this~     investigation is to explore how oxytocin may modify early maternal brain and behavioral~     responses to infant cues. This study will examine, for the first time, a potential~     pharmacological intervention for maternal neglect which targets core neurobiological~     deficits. This may eventually be used to supplement and augment other psychosocial and~     behavioral interventions.~      In addition, the investigators will examine sex differences in parental brain and behavioral~     responses to oxytocin by also recruiting the male partner of enrolled mothers to participate~     in a similar protocol.~   "
24428|NCT02737423|"~     The main objective of the study is to assess the effect of vitamin D treatment on painful~     diabetic neuropathy in Pakistan.~      This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single~     dose of 600,000 IU of Vitamin D.~      All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to~     participate in the study. The change in painful diabetic neuropathy scores was assessed~     using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at~     each visit.~   "
24525|NCT02736136|"~     This study aims to investigate the effects of an early intervention (joint observation and~     video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who~     have given birth to a very premature baby will be randomly allocated to either the early~     intervention or usual care whilst the infant is still hospitalized. Participants will be~     followed up at one month and six months. It is predicted that participants who received the~     early intervention will report higher maternal parenting self-efficacy than those who are~     not.~   "
24780|NCT02732821|"~     This study is performed to study Gastric Per Oral Endoscopic Myotomy G-POEM as a less~     invasive, effective alternative to surgery in patients presenting with gastroparesis.~   "
24781|NCT02732808|"~     This study is a prospective before & after clinical trial to investigate the efficacy of~     double stimulations during both the follicular and luteal phases in patients with poor~     ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles.~      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan~     institute. The study is conducted according to the Declaration of Helsinki for medical~     research. All participants provide informed consent after counseling for infertility~     treatments and routine IVF/ICSI programs.~      All the patients who diagnosed as poor ovarian responders (POR) based on the Bologna~     criteria are eligible for participation in this study. In order to define the poor response~     in IVF, at least two of the following three features must be present: (i) advanced maternal~     age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian~     reserve test (ORT). Two episodes of POR after maximal stimulation are sufficient to define a~     patient as poor responder in the absence of advanced maternal age or abnormal ORT.~      Stage one of treatment protocol First stimulation performs by Clomiphene citrate (Ovumid®,~     Iran Hormones Company) 25 mg/day with co-treatment of Letrozole (Letrofem®, Iran Hormones~     Company) 2.5 mg/day are given from cycle day 3 onwards. Letrozole is only given for 4 days~     and clomiphene citrate is continuously used before the trigger day. Patients start to inject~     human menopausal gonadotrophin (HMG) (Menopur®, Ferring, Switzerland) 150 IU every other day~     beginning on cycle day 6. When one or two dominant follicles (18 mm in diameter) observed,~     the final stage of oocyte maturation will be induced with triptorelin 100 μg (Decapeptyl®;~     Ferring GmbH, Germany) follows by ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo~     Company, Iran) is used on the day of oocyte maturation triggering and the day after. After~     the first oocyte retrieval, human menopausal gonadotrophin and letrozole are administrated~     to stimulate follicle development, and oocyte retrieval will be carried out a second time~     when dominant follicles have matured. All highest-quality embryos (including grade 1 and~     grade 2, eight-cell blastomere embryos) will be cryopreserved by vitrification method on the~     third day after oocyte retrieval.~      Stage two of treatment protocol:~      Transvaginal ultrasound evaluation performs after oocyte retrieval to determine whether to~     continue the second ovarian stimulation. The criterion for continued stimulation is the~     presence of at least two antral follicles 2-8 mm in diameter. A total of 225 IU HMG~     (Menopur®, Ferring, Switzerland) and letrozole 2.5 mg (Letrofem®, Iran Hormones Company) is~     administered daily from the day of, or the day after, oocyte retrieval. The initial second~     stage follicular monitoring is conducted 5-7 days later, and then for follow up every 2-4~     days, by using a transvaginal ultrasound evaluation, to record the number of developing~     follicles. Letrozole administration is discontinued when the dominant follicles reached~     diameters of 12 mm, given that large follicles have redundant LH and FSH receptors, and good~     response to exogenous hormone stimulations. Daily administration of medroxyprogesterone~     acetate 10 mg (Progestrone®, 5mg bid; Aboureihan, Iran) is added beginning on stimulation~     day 12 for cases in which post-ovulation follicle size is smaller than 14 mm in diameter and~     stimulation needed to continue for several more days. This performs to postpone menstruation~     and avoid oocyte retrieval during menstruation, to prevent the risk of infection from the~     procedure. When three dominant follicles reached diameters of 18 mm or one mature dominant~     follicle exceeded 20 mm, the final stage of oocyte maturation is induced again with~     triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) by injection. Again, ibuprofen 600~     mg (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte~     maturation triggering and the day after. Transvaginal ultrasound-guided oocyte retrieval was~     conducted 32-36 h after GnRH agonist administration. All retrieved oocytes were treated same~     as in the study stage one.~   "
24429|NCT02737410|"~     Background:~      Resilience refers to a class of variables highly relevant for wellbeing and coping with~     stress, trauma, and chronic adversity. Despite its significance for health, resilience is~     hardly examined empirically and suffers from poor conceptual integration. Irritable bowel~     syndrome (IBS) is a functional disorder with altered psychological stress reactivity and~     brain-gut-microbiota axis, which causes high chronic strain. Gut-focused hypnotherapy (GHT)~     is a standardized treatment for IBS targeting at resilience. An increase of resilience by~     GHT has been hypothesized but requires further investigation.~      Aims of the study were construct validation and development of an integrational measure of~     different resilience domains by dimensional reduction, and investigation of change in~     resilience in IBS patients by GHT.~      N=74 Gastroenterology outpatients with Irritable Bowel Syndrome (Rome III criteria) were~     examined in 7 resilience domains, quality of life, psychological distress and symptom~     severity. n=53 of these participate in 7 to 10 Gut-directed Hypnotherapy group sessions~     (Manchester protocol). Post-treatment examinations were performed 10 months after last GHT~     session.~   "
24430|NCT02737397|"~     The purpose of this study is to determine the safety and efficacy of a combination product~     for the prevention of veisalgia. Common symptoms of veisalgia following the moderate~     consumption of alcohol includes headache, fatigue, and thirst. It is the investigators~     hypothesis that a combination of two drugs can alleviate or significantly reduce these~     symptoms when taken before the start of moderate alcohol consumption.~   "
24431|NCT02737384|"~     The purpose of this study is to evaluate selective depletion of naïve CD45RA+ T cells from~     allogenic peripheral blood stem cell graft in children transplanted for combined immune~     deficiency. The aims of this procedure are to prevent graft versus host disease (GVHD) while~     preserving anti-infectious response from donor memory T lymphocytes.~   "
24432|NCT02737371|"~     Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study.~     Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group~     consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each~     subject will be dosed for 10 days and will be on study for approximately 7 weeks. Each~     subject will participate in one treatment cohort only, residing at the Clinical Research~     Unit (CRU) from Day -1 (the day before dosing) to Day 15 (120 hours post the last dose). The~     dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two~     doses divided over the 24-hour dosing period.~      All subjects will return for a post-study visit 8 to 10 days after the last dose of study~     medication.~      Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety~     and pharmacokinetic data of each cohort prior to each dose escalation.~   "
24433|NCT02737358|"~     The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC)~     to assist in initial cessation and/or relapse prevention in adult cigarette smokers.~   "
24434|NCT02737345|"~     1. Further characterize the incidence of hyperfibrinolysis in cirrhotics~        2. Correlate hyperfibrinolysis with~             1. hepatitis C~             2. alcoholic liver disease~             3. the subset of a&b with renal failure with and without dialysis~        3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics~   "
24435|NCT02737332|"~     The purpose of this study is to evaluate the serum testosterone levels in patients with~     Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as~     Compared to Abiraterone Acetate~   "
24436|NCT02737319|"~     The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention~     of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.~   "
24437|NCT02737306|"~     This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to~     evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD~     prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS~     undergoing allogeneic stem-cell transplantation.~   "
24438|NCT02737293|"~     This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med~     Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary~     fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been~     shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs~     may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat)~     levels. This study is being done to test how the addition of eggs to a Med Diet affects~     blood lipids and other risk markers for CVD.~   "
24439|NCT02737280|"~     Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen~     saturation is low. In earlier observational clinical studies, the use of high flow nasal~     cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of~     intubation and intensive care. This study is a randomized controlled trial in two pediatric~     university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen~     therapy in infants with bronchiolitis.~   "
24440|NCT02737267|"~     This study evaluates the relationship between several genetic variants and the response to a~     hypocaloric diet, in order to design a genetic test which permits prescribe the more~     personalized diet for each individual according to her genotype. Half of the participants~     will assigned to a moderate high protein diet, while the other half will assigned to a high~     carbohydrate diet.~   "
24441|NCT02737254|"~     The purpose of this study is to investigate the effects of oxytocin and a cognitive bias~     modification (CBM) procedure on children's trust in their mother.~   "
24442|NCT02737241|"~     HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and~     lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the~     apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate~     bed then intravesical morcellation of the enucleated adenoma.~      The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high~     power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate~     Hyperplasia).~   "
24528|NCT02736097|"~     Recently clinical guidelines categorize pneumonia in to three types: community,~     healthcare-associated, and hospital-acquired. Much of the existing research to describe the~     epidemiology of pneumonia in critically ill patients comes from single-center studies or~     from retrospective database analyses, which limit generalizability and lead to~     over-prescription of broad-spectrum antibacterial agents. This will be a prospective,~     multicenter epidemiological study to characterize pneumonia epidemiology in critically ill~     adult patients.~   "
24443|NCT02737228|"~     <Part I - Phase I trial>~      The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose~     Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial~     dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or~     it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose~     level.~      Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as~     fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts~     according to the dose level. Each cohort consists of 3 or 6 subjects.~      <Part II - Phase II trial>~      In the phase II clinical trial, the subjects will be administered with the dose which is to~     be identified as a recommended dose based on the results of Phase I study. The whole one~     cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles~     and tumor assessment is evaluated every 2 cycles.~   "
24444|NCT02737215|"~     Background. Atrial fibrillation is one of the most common complications in the postoperative~     period of coronary artery bypass grafting (CABG) surgery and usually associated with~     increased length of hospital stay and higher hospital costs. Among the main mechanisms~     involved, excessive sympathetic activation, oxidative stress and inflammation are~     fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To~     evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial~     fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures:~     A multicenter randomized controlled study to compare the incidence of atrial fibrillation~     between the intervention group and the control group, both monitored seven days with Holter.~   "
24445|NCT02737202|"~     This study is being done to determine if there is a potential benefit of saracatinib in LAM~     subjects. Based on the information of this trial, additional clinical development trials~     will be needed. The study will also test the tolerability of 125 mg of saracatinib given~     once daily over a 9 month period.~   "
24446|NCT02737189|"~     Endovascular treatment of acute ischemic stroke has shown strong benefit in several~     prospective randomized trials in the anterior circulation and endovascular therapy for~     basilar artery occlusion has shown promising results in several single-arm studies. This has~     led to a broad adoption of these techniques which are now considered standard of care in~     many institutions despite the lack of adequate evidence to prove their benefit. Indeed, the~     rates of symptomatic intracerebral hemorrhage in these studies have consistently been around~     5% which raises the question as to whether patients could actually be harmed as opposed to~     helped by these procedures. This is a prospective, multi-center, randomized, controlled,~     open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical~     embolectomy with the Solitaire device is superior to medical management alone in achieving~     better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of~     the basilar artery within 6-24 hours from symptom onset.~   "
24447|NCT02737176|"~     This study is to verify the efficacy of tobacco cessation in patients with oral diseases;~     periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.~     Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation~     intervention for the subjects, attending doctors implement standard treatments for their~     oral diseases. Improvement of each disease is evaluated between smoking cessation~     intervention group and non-cessation intervention group.~   "
24448|NCT02737163|"~     The treatment of hydrocephalus is the most time consuming, and arguably the most important~     role of the pediatric neurosurgical service at most children's' hospitals. Despite many~     technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay~     of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated~     with high complication rates and account for a disproportionate share of health care~     expenditures and morbidity.~      Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick~     and painless transcutaneous reprogramming, have been implanted for more than 15 years in the~     developed world. Reprogramming these valves relies on rotational magnetic forces, which are~     applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent~     reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields~     in the environment, which may lead to serious symptoms that may require urgent reprogramming~     and/or surgery.~      The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and~     household items that generate substantial magnetic fields has caused concern among patients,~     parents and providers about the potential consequences of inadvertent valve reprogramming.~     This growing concern led the FDA to issue a warning to individuals with programmable valves~     in 2014, which deemed the programmable valves safe for use but vulnerable to IR when~     household devices such as tablets or cell phones are placed within 2 inches of the valve.~     The FDA recommended further study, stating that no systematic evaluation had been performed~     regarding the prevalence of accidental valve adjustments.~      By evaluating each of the patients with magnetically susceptible CSF shunt valves, during~     each of the routine points of contact with the service, investigators aim to define the~     prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of~     symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt~     reprogramming based on exposure to common environmental items.~   "
24449|NCT02737150|"~     Aim of the study is to demonstrate equivalence of second-generation self-expandable valves~     (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards~     Sapien 3) and of local anesthesia with conscious sedation in comparison to general~     anesthesia with respect to safety and efficacy in high-risk patients with severe aortic~     stenosis undergoing transcatheter aortic valve implantation.~   "
24450|NCT02737137|"~     In clinical practice, local anesthetic injection pressure monitoring is performed manually~     or by a pressure transducer according to the availability of the equipment or preferences of~     clinicians. To date, no comparative study has measured the advantages of this measure during~     PNB.~      The aim of this study is to evaluate injection pressure monitoring in order to reduce the~     risk of intraneural injection during peripheral nerve blocks~   "
24451|NCT02737124|"~     Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will~     take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be~     given a similarly looking placebo pill. A multitude of post-op variables will be included,~     mainly pain scores and morphine equivalent doses at different time points.~   "
24526|NCT02736123|"~     This study plans to test the pathologic complete response (pCR) rate of the combination~     biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in~     patients with advanced but operable melanoma. Evaluation of the presence of~     tumor-infiltrating CD8+ T cells as well as that of PDL1 expression and IDO expression will~     be associated with clinical response (pathologic and/or radiologic). The study will test the~     radiologic/clinical preoperative response rate, recurrence free survival (RFS) and overall~     survival (OS). It will evaluate the safety of neoadjuvant nivolumab and neoadjuvant~     nivolumab-ipilimumab. Up to 66 patients will be randomized in 1:1 ratio.~   "
24452|NCT02737111|"~     This study aims to further understand the experiences of children, their parents and~     siblings around the time when the child and their family are informed of a diagnosis of an~     inherited cardiac condition (ICC). The researchers are interested to understand how families~     experience the process of receiving a diagnosis of an ICC, and explore experiences from~     multiple perspectives within the family (i.e. parents, children and siblings).~      The Primary Project Objective:~      How do children, their parents and siblings experience the communication of a diagnosis of~     an inherited cardiac condition (ICC)? What is found to be helpful and less helpful?~      The Secondary Project Objective:~      To explore qualitatively how families experience the communication of a positive diagnosis~     for an inherited cardiac condition for a child and will seek the perspectives of the child~     with the diagnosis, their siblings and parents.~   "
24453|NCT02737098|"~     The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in~     rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of~     Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically~     dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of~     services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved~     access to first class primary care services, it has been more challenging to deliver~     specialty mental health care to rural Veterans. Evidence based specialty mental care~     practices developed for large VA Medical Centers are often not feasible to deploy in small~     CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress~     disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over~     time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based~     psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel~     barriers prevent most rural Veterans from receiving trauma-focused evidence-based~     psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a~     technology-facilitated virtual care clinical intervention that is designed to enhance access~     to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and~     Office of Connected Health and Telehealth Services intend to deploy the TOP intervention~     nationally. This project will lay the ground work for this national implementation~     initiative.~      The goal of this implementation project is to support the national deployment of the TOP~     intervention and evaluate its clinical effectiveness in routine care. The specific aims are~     to compare the cost and effectiveness of alternative implementation strategies to promote~     uptake of TOP and assess impact on access and PTSD outcomes.~      The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists~     trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size~     will be 600.~      The TOP clinical intervention is delivered by a virtual care team comprising a CBOC~     provider, and a telephone care manager, telepsychologist and telepsychiatrist located at the~     VAMC. The telephone care managers will coordinates care. The telepsychologists will deliver~     of trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric~     consultation. The standard VA implementation strategy will follow standard procedures for~     deploy clinical practices in the VA include disseminating support materials, providing~     technical assistance and transfer funds to hire clinical personnel. The enhanced~     implementation strategy will add external facilitation to the standard VA implementation~     strategies. External facilitation will begin with an assessment of the current workflow at~     the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then~     generate a clinical workflow chart that describes the current process of care. With advice~     from the external facilitation team, local staff will then incorporate the clinical process~     of the TOP intervention into the current clinical workflow chart.~      The project will compare the standard VA implementation strategy to the enhanced~     implementation strategy. All VAMCs will receive the enhanced implementation strategy if they~     need it, but the time period during which they will receive the enhanced implementation~     strategy will be randomized. This will allow us to determine whether more patients are~     reached by the TOP intervention during standard implementation compared to enhanced~     implementation. This design will also allow us to document improvements in perceived access~     and PTSD outcomes for patients at sites that successfully implement the TOP intervention.~     Data will be collected from patient survey and chart review for all patients sampled for the~     evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys.~     The reach implementation outcome measure will be specified as the proportion of sampled~     patients who received the TOP intervention. PTSD outcomes will be specified as a continuous~     change in patient self-reported symptom severity between baseline and follow-up. Perceived~     access will be measured using items specifically developed for the project. Provider~     adoption will be assessed with qualitative interviews of all CBOC clinicians treating a~     sampled patient as well as members of the TOP intervention team. Costs - The investigators~     will measure the cost of both implementation strategies both prospectively and~     retrospectively. The investigators will collect data on implementation activities during~     both the standard VA and enhanced implementation strategies.~   "
24454|NCT02737085|"~     The main purpose of this study is to explore the sequential therapeutic effect of~     CD19-targeted and CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of~     Diffuse Large B Cell Lymphoma(DLBCL)~   "
24455|NCT02737072|"~     The main purpose of this study is to evaluate the safety and tolerability of chemokine~     (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a~     and 1b in participants with advanced refractory solid tumors.~   "
24456|NCT02737059|"~     This is a single center, randomized, double-blind, placebo-controlled, parallel-group, Phase~     I study of the effects of naloxegol, a novel mu-opioid antagonist, on gastrointestinal and~     colonic transit in the presence or absence of the mu-opiate, codeine. There is a need to~     develop effective medications for the treatment of opiate-induced constipation and other~     motility disorders. Currently available opiates are complicated by addictive potential and~     induction of troublesome constipation.~   "
24457|NCT02737046|"~     The investigators propose to use Belinostat in combination with AZT as consolidation therapy~     for the treatment of ATLL.~   "
24458|NCT02737033|"~     This study evaluates the use of Rhodiola rosea in the attention of adults with Attention~     Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea~     800mg, while the other half will receive 800mg of placebo.~   "
24459|NCT02737020|"~     This study evaluates the use of Rhodiola rosea in the treatment of Attention~     Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola~     rosea, while the other half will receive placebo.~   "
24460|NCT02737007|"~     This is an open-label, single-centre, non-randomized study to investigate the~     pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy~     male subjects.~      Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The~     study will provide an early readout on human pharmacokinetic parameters. The results of this~     study will be used to estimate the potential duration of anti-parasite effect in humans,~     define predicted clinical oral doses, and hence inform about the compound's potential safety~     margin.~      Each subject will participate in the study for up to 8 weeks, and will have a screening~     visit, one treatment period, eight outpatient visits, and a follow-up visit.~   "
24461|NCT02736994|"~     The aim of this study is to evaluate the effect of PIP toothbrush cleaner® on the microbial~     composition and Candida albicans colonization of denture biofilm formation. Additionally,~     its effect will be compared to that of cleansing tablets.~   "
24462|NCT02736981|"~     This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational~     approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a~     BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous~     Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a~     6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up~     period.~   "
24463|NCT02736968|"~     This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment~     study to compare placebo to once daily doses of 6mg auranofin for adults with asymptomatic~     amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm)~     and 68 with giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with~     giardiasis completing the study. Primary objectives are 1) to compare the proportion of~     subjects with parasitological response (no detection of cysts or trophozoites of E.~     histolytica on microscopic exam or negative antigen detection) by Day 7 for E. histolytica~     infections and 2)to compare the proportion of subjects with parasitological response (no~     detection of cysts or trophozoites of G. lamblia on microscopic exam or negative antigen~     detection) by Day 5 for Giardia infections. The length of this study is set for 3.5 years;~     subject participation is 7 days treatment (amebiasis) and 5 days (giardiasis) with follow-up~     until day 28~   "
24464|NCT02736955|"~     This Phase 3b, rollover study will provide subjects who completed a Phase 3 valbenazine~     (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for~     the treatment of TD until valbenazine is anticipated to be available commercially or they~     complete 72 weeks of treatment. This study will allow enrollment of up to 75 medically~     stable male and female subjects with TD who previously participated in and completed the~     NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.~   "
24472|NCT02736851|"~     The aim of the study is to investigate if a home-based structured physician-directed,~     nurse-managed telemedicine program can increase adherence to a home exercise program and~     decrease neck pain and disability.~      The study is carried out in 100 consecutive patients with chronic non-specific neck pain.~      All patients referred to a rehabilitation Institute for an out-.patient visit complete a~     stretching exercise program and are instructed and encouraged to perform exercises regularly~     once at home. At the end of the rehabilitation, the patients are randomized into two groups~     of 50 patients each. Patients of the first Group are allocated to a home-based telemedicine~     (HBT), while those of the second group receive only the recommendation to continue~     exercising at home (Control group). The HBT intervention consists of fortnightly scheduled~     phone calls to patients over the 6-month course of the study. A nurse-tutor encourages the~     patient to perform regularly physical activity and prescribes exercises.~      Adherence to home exercises is evaluated 15 days and 6 months after the end of the~     outpatient rehabilitation, while pain intensity and neck disability are assessed and~     compared in the two groups at entry and 6 months after the end of the outpatient~     rehabilitation .~   "
24465|NCT02736942|"~     Background Surgery for mid and low rectal cancer is associated with relative high rates of~     incomplete mesorectal excisions and high rates of circumferential resection margin (CRM)~     involvement resulting in significant number of local recurrences. Moreover, patients with~     mid and low rectal cancer suffer from high rates of morbidity, permanent colostomies and~     impairment of quality of life. The transanal TME (TaTME) has been developed to improve the~     quality TME in mid and low rectal cancer.~      Study design The COLOR III trial is an international multicentre randomised study comparing~     short- and long-term outcomes of TaTME and laparoscopic TME for rectal cancer. The study~     will include a quality assessment phase before randomisation to ensure required competency~     level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial~     clinical data will be reviewed centrally to ensure uniform quality.~      Endpoints Primary endpoint is involvement of CRM. Secondary endpoints include morbidity and~     mortality, residual mesorectum (postoperative MRI), local recurrence, disease-free and~     overall survival, percentage of sphincter saving procedures, functional outcome and quality~     of life.~      Statistics In laparoscopic TME the percentage of involved CRM is estimated 7%. To detect a~     reduction to 3% with a two-sided level of significance of 5% and a power of 80% a total of~     1098 patients is needed. Randomisation will be in a 2:1 ratio in favour of the TaTME~     procedure. It will be stratified for T-stage, preoperative radiotherapy, height of the~     tumour, gender and BMI. All analyses will be on intention-to-treat basis.~      Main selection criteria Patients with a histologically proved single mid or low rectum~     carcinoma (0-10cm from anal verge) on MRI, eligible for TME surgery with a curative intent,~     are included. Main exclusion criteria are T4 tumours, T3 tumours with a suspected involved~     mesorectal fascia (MRF) after neoadjuvant therapy, patients with concomitant metastases or~     other malignancies, with malignancies in their medical history or with signs of acute~     mechanical obstruction by the tumour.~      Hypothesis The hypothesis is that TaTME will result in a better mesorectum specimen quality~     with a lower rate of involved CRM and therefore lower rate of local recurrence. Furthermore,~     the TaTME procedure will potentially enable more sphincter saving procedures and will have~     positive effect on functional outcome and health related quality of life.~   "
24466|NCT02736929|"~     Some individuals who are exposed to traumatic events experience both psychological and~     cardiovascular changes that affect their health and well-being. The purpose of this study is~     to learn more about how reducing the psychological symptoms (such as those that occur with~     posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart~     and blood pressure.~   "
24467|NCT02736916|"~     Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with~     limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several~     side effects, such as decline in memory and other cognitive functions. This provides the~     rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous~     studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the~     hippocampus without detriment to the radiation dose the remaining brain receives. The aims~     of this study is to evaluate the therapy efficacy and the safety profile of~     hippocampal-sparing whole-brain radiation therapy (HS-WBRT) for PCI in patients with~     LD-SCLC.~   "
24468|NCT02736903|"~     Despite the racial disparities in rates of chronic diseases and behaviors linked to chronic~     diseases, there have been relatively few RCTs of interventions to increase physical activity~     in African American women. Although some studies found significant improvement on physical~     activity, most focused on individuals and did not take into consideration the social~     contexts in which the participants' behaviors occurred. Understanding how online social~     networks facilitate behavior change can bridge important gaps in the way technology can be~     used to intervene on health among underserved populations. The primary objective of this~     study was to test the efficacy of a mobile app (PennFit) intervention in increasing~     participants' daily active minutes objectively recorded by a fitness tracking device (Fitbit~     zip). In the control group, participants used the PennFit app to record and monitor their~     own physical activity progress. In the online social network intervention, participants were~     randomized to 4-women networks and were able to see and compare their own recorded physical~     activities with activities of the other three women in their network. Participants in a~     network had access to an online chatting tool to chat with one another. The secondary~     objective was to understand the intervention's mechanisms through mediation analysis on~     theoretical variables.~   "
24469|NCT02736890|"~     Back pain is a common secondary condition of both acute and chronic spinal cord injury~     (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are~     limited by marginal efficacy or intolerable side effects. The purpose of this study is to~     evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain~     relief in spinal cord injury patients with back pain near the level of injury in the spine.~     Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with~     nerve pain. The researchers propose a double blinded placebo controlled crossover study to~     study the effects of subcutaneous botulinum injections to at--level SCI back pain in~     patients with spinal cord injury.~   "
24470|NCT02736877|"~     The investigators will evaluate 30 patients with surgical indication for corneal~     transplantation. Participants will be divided according to the following diseases diseases:~     keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about~     the risks and benefits of the study and sign an informed consent form. In the preoperative~     evaluation will be submitted to a complete ophthalmologic examination with complementary~     tests, such as optical coherence tomography.~      One group of participants will undergo corneal surgery using the OCT Lumera microscope~     RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their~     filmed and documented surgery. The team of surgeons will answer the questionnaire on the~     surgical difficulty about the ease of assessing corneal transplantation. After surgery,~     participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.~      Surgeries and study procedures will be performed by the same team of surgeons and performed~     by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.~   "
24471|NCT02736864|"~     The study assesses patients with cured pulmonary tuberculosis by compulsory notification~     data of Uberlândia (Minas Gerais state - Brazil) from 2013, 2014 and 2015. These patients~     will be randomly selected and invited by telephonic contact. After eligibility and exclusion~     criteria evaluation, those included will be assessed in order to know structural and~     functional repercussions of pulmonary tuberculosis sequelae.~   "
24489|NCT02736630|"~     Primary objective of the study is to project the incidence rate of perioperative hypothermia~     under general anesthesia in patients who go under minimum 1 hour long elective surgery in at~     least 25 hospitals/medical centers in Turkey .~      Secondary objectives are to determine the patient risk factors associated with perioperative~     hypothermia, to determine the surgery risk factors associated with perioperative~     hypothermia, to determine the other risk factors associated with perioperative hypothermia,~     intraoperative infusion volume and effect of warming, intraoperative irrigation volume and~     effect of warming, intraoperative blood infusion volume and effect of warming, to determine~     complications related to perioperative hypothermia, to improve patient temperature~     management awareness and processes.~   "
24473|NCT02736838|"~     Objectives: 1. To analyze the changes in peripheral tissue oxygenation in tissues subjected~     to different pressure regimes in healthy humans. 2. To analyze changes in microvascular flow~     in peripheral tissues subjected to different pressure regimes in healthy humans. 3. To~     determine thresholds of tissue perfusion flow and transcutaneous oxygen depending on~     exposure levels and angling pressure in healthy volunteers. 4. To evaluate the distribution~     of tissue perfusion flow and transcutaneous oxygenation in real clinical situations in~     residential care and acute hospital care in patients at risk for impaired skin integrity.~      Methodology:~      Experimental non-controlled, non-randomized study in two phases: preclinical and clinical.~     The first phase, will be conducted in healthy volunteers and the second, in patients at risk~     for impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in~     areas at risk of pressure ulcers by Doppler laser will be evaluated in subjects lying on a~     capacitive surface to measure pressure with 10,249 points of measurement, which will be~     subject to different body systems to generate different levels of pressure and monitor~     changes in tissue perfusion and oxygenation up to 4 hours, to know the implications for~     repositioning interventions in patients at risk.~   "
24474|NCT02736825|"~     Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to~     one of two treatment groups. Subjects meeting all entrance criteria will receive study~     treatment, then complete two post treatment phone contacts and follow-up study visits at 90,~     180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit for qualitative and quantitative assessments of~     efficacy.~   "
24475|NCT02736812|"~     In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes~     bleeding. The plasma allows, through its contribution of coagulation factors, early~     prevention or correction of this post-traumatic coagulopathy. The main objective is to show~     the effectiveness of pre-hospital administered FLYP during treatment of a traumatic~     hemorrhagic shock, in the occurrence or the treatment of a post traumatic coagulopathy.~      Study Design~      This is a Randomized controlled multicenter open study in two parallel groups. Eligibility~     criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood~     pressure <70 mmHg] or [systolic blood pressure between 71 and 90 mmHg AND heart rate > 108],~     or Shock Index >1.3 at some point in the medicalized care. Two groups of 70 patients will~     receive either FLYP+ the usual treatment for post traumatic hemorrhagic shock as given in~     the recommendations for best practice, or saline perfusion but no FLYP, as given in the~     recommendations for best practice. The primary endpoint is the variation in the level of~     Prothrombin (PR), between the PR at hospital admission and the PR originally taken in the~     pre-hospital period.- The secondary endpoints are: compilation of technical and logistical~     difficulties encountered before, during and after administration of FLYP ; the change in~     fibrinogen level between fibrinogen level at hospital admission and fibrinogen level~     originally taken in the pre-hospital period. The study must confirm the link between~     causality of early administration of plasma in improving post-traumatic coagulopathy. The~     study must show safe usage in out-of-hospital situations and the ability of medical staff to~     meet the requirements of the health authorities in terms of product use as well as in terms~     of traceability of the victims and the treatment they received.~   "
24476|NCT02736799|"~     The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal~     disorders. The effect of different vibrations on the motor functions of the gastrointestinal~     tract are unclear. The study will focus on the stomach in healthy volunteers.~      The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment~     on gastric emptying and gastric motility in healthy volunteers.~   "
24477|NCT02736786|"~     This study is an observational study evaluating the clinical outcomes of mucosal sparing~     proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients.~     Subjects will be screened at outpatient clinic visit appointments and interested qualified~     subjects will be consented and offered participation in this study. Once consent has been~     obtained baseline adverse event and Quality of Life (QOL) data will be collected and~     subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No~     study-specific visits or evaluations will be required. Patients will be evaluated according~     to the physician's standard practice and discretion. Patient data will be drawn from the~     patients' medical records and reported by means of a web-based electronic data collection~     (EDC) system. Patients will be considered on study until 24 months of observation has~     occurred, withdrawal of consent, lost to follow-up, or study closure.~   "
24478|NCT02736773|"~     The aim of this study is to evaluate the volume of madibular bone after placement of a~     xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the~     teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3~     walls intact and the buccal wall at 80% . This study will include 30 patients.~   "
24479|NCT02736760|"~     This study is a multicenter study investigating the clinical efficacy of repetitive~     daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to~     prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly~     allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5)~     will be performed within 18 months. In the control group, cryosurgery will be performed at~     visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.~      In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face~     and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion~     preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin~     layer to the whole face. Within 30 min after MAL application patients expose themselves to~     daylight for 2 hours. In the control group, cryosurgery will be performed using liquid~     nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at~     visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer~     by documenting all existing and newly appearing AKs in the face.~   "
24490|NCT02736617|"~     This phase II trial studies how well obinutuzumab works in combination with ibrutinib in~     treating patients with mantle cell lymphoma that has returned (relapsed) or that does not~     respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of~     differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma~     cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called~     Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving~     obinutuzumab in combination with ibrutinib may kill more cancer cells.~   "
24527|NCT02736110|"~     This registry study will compile information from patients that are scheduled to receive or~     have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to~     treat osteoarthritis in the knee.~   "
24540|NCT02735941|"~     The purpose of the study is to investigate phospholipid ligands and their receptors in~     inflammatory bowel diseases and colon cancer. Several new species of lipids have been~     recently discovered which are able to transmit information to cancer cells in the large~     intestine. The lipids and their responsive receptors build an axis that is thought to~     influence the development of inflammation and cancer.~   "
24480|NCT02736747|"~     The stroke has been described as the third cause of death and main cause of disability in~     the worldwide population. About 60% of the survivors are able to walk following the~     rehabilitation process, however deficits on lower limbs functions often persists in most~     cases, affecting the gait and functional mobility. In this sense, several interventions are~     applied in the clinical practice to optimize the functional performance. Cryotherapy is one~     of the most used techniques aiming to reduce spasticity temporarily, allowing the training~     of functional tasks, such as walking. The aim of the present study is to evaluate the~     immediate effects of cryotherapy (ice pack) on neuromuscular performance, proprioception,~     passive resistance of dorsiflexors and plantarflexors muscles, and also on gait performance~     in chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in~     this crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo)~     will be randomized. Fifteen days of washout period will be considered. The~     cryotherapy/placebo will be applied on the posterior area of the leg for 20 minutes.~     Initially Fugl Meyer will be applied. All other assessments will be performed before and~     after intervention: spasticity level, classified according to Modified Ashworth Scale;~     temporo-spatial and angular parameters for trunk, hip, knee and ankle during gait, using a~     motion analysis system (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position~     sense), passive resistance to stretching, isometric and isokinetic torques during~     contractions of plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic~     dynamometer. Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior~     and peroneus will be assessed by electromyography during isokinetic dynamometer assessment~     and gait. The following electromyographic variables will be analyzed: maximum activation~     amplitude, muscle onset, coactivation index between agonists and antagonists. For~     statistical analysis, normality (Shapiro Wilk) and homogeneity (Levene) tests will be~     applied. If the variables have a distribution considered normal and homogeneous, Two-way~     ANOVA with repeated measures will be applied. Otherwise, non-parametric statistics (Friedman~     test) will be applied. A significance level of 0.05 will be considered for all statistical~     tests.~   "
24481|NCT02736734|"~     Stress is well known to affect visceral sensitivity and gastrointestinal function in~     general. A majority of patients with gastroesophageal reflux disease (GERD) report stress as~     an important factor triggering symptom exacerbation. A real-life stressor could exacerbate~     heartburn symptoms in GERD patients by enhancing perceptual response to esophageal acid~     exposure. In Irritable Bowel Syndrome (IBS) patients, visceral hypersensitivity is a major~     pathophysiological mechanism and stress is shown to trigger or exacerbate symptoms.~      A possible mechanism of stress−induced visceral sensitivity could be the barrier~     dysfunction. Indeed, in a study performed by our group, in human, an acute psychological~     stressor induces hyperpermeability in a mast cell dependent fashion and exogenous peripheral~     corticotrophin-releasing hormone (CRH) recapitulated its effects on barrier function. This~     increase in intestinal permeability is a phenomenon which appears as a prerequisite for~     visceral hypersensitivity. Furthermore, few studies indicate that human intestinal motility~     is probably modulated by CRH. It has been shown that the brain-gut axis in IBS patients has~     an exaggerated response to CRH.To our knowledge, the acute effect of exogenous CRH on~     esophageal motility has not been studied before.~   "
24482|NCT02736721|"~     This study will evaluate the efficacy, safety and tolerability of long-term use of~     peginterferon alfa-2a in participants with CML who have previously participated in~     peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not~     available) or ML17228 (NCT number not available) and treating physician has decided to~     continue treatment with peginterferon alfa-2a within the frame of another clinical study.~   "
24483|NCT02736708|"~     Primary sclerosing cholangitis (PSC)~        1. Prospectively validate interpretation criteria for the characterization of PSC~          strictures~        2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures~          (differentiation between malignant vs. non malignant strictures), using the newly~          developed interpretation criteria~        3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures~   "
24484|NCT02736695|"~     This study is designed to learn more about overall tau burden in the brain of patients with~     Primary Progressive Aphasia (PPA).~   "
24485|NCT02736682|"~     Delivery by Cesarean section is increasing worldwide and this is the most important risk~     factor for post partum infection where there is a 5-20% risk of developing post partum~     infection than women who deliver vaginally Provision of single dose broad spectrum~     intravenous antibiotics 30-60 minutes before cesarean section has been found to be as~     effective as multiple doses in reducing post operative infections. At Mulago National~     referral Hospital mothers who have had elective and are at low risk of post partum infection~     also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of~     the study is to further inform us that single dose preoperative antibiotic prophylaxis is~     effective in prevention of post operative infection in mothers delivered by elective~     cesarean section.~   "
24486|NCT02736669|"~     This research study will compare two weight loss programs that provide different~     recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in~     an effort to determine if fixed calorie reduction or varied calorie reduction is more~     effective for weight loss.~   "
24487|NCT02736656|"~     This is a multicenter, open-label extension study aimed to assess long-term safety and~     efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug~     Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the~     treatment of ADHD in pediatric subjects who have participated in a previous blinded study of~     SPN-812 ER. All pediatric subjects who complete a blinded study of SPN 812 ER will have the~     option to participate in this study in which all subjects receive SPN-812 ER. After an~     initial dose, subjects will enter an dose optimization phase for three to nine weeks.~     Following optimization, subjects will return to the clinic every 3 months or until the~     subject discontinues or the study ends at 36 months.~   "
24488|NCT02736643|"~     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis~     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought~     to be the best screening tool for lung cancer. However, there is growing concerns about~     radiation exposure, high cost, and high rate of false-positive screening result.~     Epidemiology data for LDCT screening in Taiwan is lacking.~      National Taiwan University Hospital Chu-Tung Branch (NTUHCT) initiated the lung cancer~     screening by LDCT since June 2015. Many people can get the LDCT screening with affordable~     price with the subsidy from enterprise donation. The purpose of this study is establishing~     local epidemiological result via telephone follow-up and patients' medical records~     retrospectively.~   "
24541|NCT02735928|"~     Patients with first recurrent resistance ovarian cancer and disease progression with~     peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to~     determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol~     chemotherapy with a combination of cisplatin and doxorubicin.~   "
24491|NCT02736604|"~     Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant~     postoperative discomforts and lead to serious complications of aspiration of gastric~     contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax.~     The incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain~     high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and~     is associated with significant morbidity. It may also result in delayed discharge, which is~     particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more~     susceptible to PONV than men and breast surgery, which is primarily done in an outpatient~     setting, is associated with high incidence of PONV, ranging between 15% and 84% in the~     absence of prophylactic treatment.~      Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the~     incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms:~     (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic~     system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has~     been demonstrated to increase the incidence of PONV in some studies but not in others. The~     present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia~     on the undesirable clinical outcome of PONV.~   "
24492|NCT02736591|"~     300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or~     intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using~     computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg~     ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a~     placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of~     human chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s.~     daily for 12 weeks before ICSI in addition to GH (Somatotropin, Sedico, Egypt) 4 IU on day 6~     of hMG stimulation in a daily dose of 2.5 mg subcutaneous (SC) until the day of hCG~     triggering.~      Patients included in the study will be subjected to full history taking and clinical~     examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will~     be assessed and the antral follicular count (AFC) will be assessed using a vaginal~     ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (hMG) stimulation until the day of hCG administration. On the day of hCG administration,~     ovarian ultrasound scan will be performed using a transvaginal probe. Oocytes will be~     aspirated 34-36 hours after HCG administration. Oocytes will be fertilized and embryos will~     be transferred. Both groups will be compared regarding the proportion of ongoing pregnancy.~   "
24493|NCT02736552|"~     The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year~     as adjuvant chemotherapy after D2 resection in patients with gastric cancer.~      Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority~     to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.~   "
24494|NCT02736539|"~     This study is designed as a randomized double-blinded treatment trial among travelers' to~     geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be~     randomized to receive Bimuno® or masked placebo to be taken daily while traveling. The test~     article or placebo will be taken starting 7 days prior to travel.~   "
24495|NCT02736526|"~     The purpose of this study is to determine the long-term effect and security of the surgical~     treatment and observation only on ocular alignment, binocular stereopsis, and quality of~     life in children with moderate intermittent exotropia.~   "
24496|NCT02736513|"~     Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be~     assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.~      In case of isolated CNS progression which may or may not be accompanied by asymptomatic~     systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients~     whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or~     WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a~     standard dose after the end of radiotherapy course in the absence of symptomatic systemic~     progression. The treatment will be continued until symptomatic systemic progression,~     unacceptable toxicity or further intracranial progression following brain radiotherapy~     administration (whichever occurs first). All patients will be followed until death or 5~     years.~   "
24497|NCT02736500|"~     The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with~     177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients~     affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the~     effects of the capecitabine metronomic schedule on the level of circulating angiogenetic~     factors.~   "
24498|NCT02736487|"~     The purpose of this research project is to examine whether short-term use of portable air~     pollution filtration can result in changes in indoor airborne pollutants and impact on~     cardiovascular and respiratory health outcomes of the inhabitants.~   "
24499|NCT02736474|"~     The purpose of this research is to observe the efficacy of Naltrexone and Bupropion~     combination on weight loss and smoking cessation from baseline to week 24 compare to~     placebo.~   "
24500|NCT02736461|"~     In patients suffered from floor fractures, there are 21.9% complaining about diplopia before~     fracture repair surgery and 20.8% after operation. Even after 6 months, there still are~     16.4% had similar conditions. Investigators are planned to find predicting factors to~     prevent such conditions from happening.~   "
24501|NCT02736448|"~     This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic~     neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%),~     somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and~     will be randomly assigned to 2 different arms:~        -  Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq~          per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR~        -  Arm Lu-PRRT: Lu-PRRT (at 3.7 gigabecquerel (Gbq) per cycle x 7 cycles) followed by~          SS-LAR.~   "
24502|NCT02736435|"~     The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment~     of uterine fibroids in Northwestern Ontario, which is a rural and remote setting.~   "
25434|NCT02724254|"~     This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety,~     tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074~     5% Gel for up to 16 weeks in condyloma patients~   "
24503|NCT02736422|"~     Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI)~     provides novel regional functional images of the lungs. Over the past 14 years researchers~     at Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been~     developing and evaluating different MRI techniques to investigate different aspects of the~     lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these~     new methods in volunteers with healthy and diseased lungs. This proposed study is to further~     test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This~     protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance~     imaging in the lungs and monitoring the transient changes in vital signs during and~     following the gas inhalation. This includes evaluation of pulse sequences to image xenon in~     the heart and brain as well as in the lungs of volunteers.~   "
24504|NCT02736409|"~     This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in~     adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis~     (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The~     primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks.~     Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia~     Symptom Questionnaire (DSQ) score.~   "
24505|NCT02736396|"~     The study objective is to correlate global cognition and episodic memory performance to~     resting state fMRI functional connectivity. This is a non-treatment, prospective, natural~     history data collection study in a cross-sectional cohort of patients with cognitive~     impairment.~   "
24506|NCT02736383|"~     To determine if TXA utilization is effective at reducing transfusion rates in elderly~     patients undergoing surgery for treatment of a hip fractures.~   "
24507|NCT02736370|"~     To evaluate the association of functional outcomes measures, return to work status, pain~     scores and hardware failure on early protected and unrestricted weight bearing versus~     delayed weight bearing in operatively repaired rotational Bimalleolar and Trimalleolar ankle~     fractures not requiring fixation of the syndesmosis.~   "
24508|NCT02736357|"~     The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000~     non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that~     identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and~     other exposures), host genetic, tumor, and treatment factors, as well as the interaction~     among these factors, on short and long-term outcomes. These efforts will identify new~     approaches to improve the survival and well-being of NHL patients.~   "
24509|NCT02736344|"~     The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug~     combination product comprising:~        -  Stent - mounted Cobalt Chromium (CoCr) alloy based stent~        -  Delivery System - Rapid Exchange (RX) Coronary System~        -  Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating~          (CarboSil®)~        -  Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The~          product is indicated for improving coronary luminal diameter in patients with~          symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm~          to 4.25mm, including complex lesions.~   "
24510|NCT02736331|"~     Primary objective is to assess the effect of the intake of different types of fruits on~     memory and attention.~      Secondary objective is to assess effect of intake of different types of fruits on metabolic~     markers, including glucose, insulin, total cholesterol and triglyceride and the~     pharmacokinetic profile of the anthocyanins.~   "
24511|NCT02736318|"~     Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile~     osteochondral graft. To avoid having to harvest autograft material from the knee, a~     processed allogeneic osteochondral can be used instead autograft. The surgical technique is~     to implant in the osteochondral defect one to three products in the defect.~   "
24512|NCT02736305|"~     Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in~     angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1~     Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR).~     Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular~     endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have~     shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with~     bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone~     in the management of ovarian cancer both as part of frontline adjuvant treatment and as~     second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been~     FDA approved for the treatment of patients with metastatic colorectal cancer who have failed~     prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.~   "
24513|NCT02736292|"~     A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in~     Training: Clinical Applications, will be piloted to determine the feasibility,~     acceptability, accessibility, and preliminary effects within this population.~   "
24514|NCT02736279|"~     Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial~     species of the gut. The primary objectives of this study are:~        1. Determine whether a measureable change in bacterial species representation follows the~          institution of DMF.~        2. Determine whether a specific pattern of change in the microbiota phylotype with DMF~          therapy correlates to onset and severity of gastrointestinal disturbances (heartburn,~          nausea, flatulence, and diarrhea).~        3. Determine whether any instability of microbiota phylotype representation persists~          following the institution of DMF or whether stabilization relates to resolution of~          gastrointestinal disturbances.~        4. Determine whether there is a correlation between a pre-existing functional bowel~          disorder and development or severity of gastrointestinal disturbances and of peripheral~          eosinophilia.~      Design: Double-blinded, prospective, single-center pilot study.~      Patient Population: Individuals 18 years or older, with a confirmed diagnosis of a relapsing~     form of multiple sclerosis.~      Treatment Groups: This study will be an open-label prospective study design with respect to~     MS immunomodulatory therapy choice. Study group will be defined as subjects with a relapsing~     form of multiple sclerosis, as defined by the McDonald criteria, choosing to begin DMF~     therapy.~   "
25435|NCT02724241|"~     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and~     sham control, on sympathetic nerve activity and markers of oxidative stress.~   "
24515|NCT02736266|"~     Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after~     transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological~     presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly~     prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks~     of the last dose (accounting for a total of 9 weeks).~      Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography~     (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy,~     patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically~     node-positive disease will be managed according to local guidelines. Further anti~     programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given~     post-operatively.~      PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody~     (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as~     any staining in the stroma or in ≥1% of tumor cells.~      Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who~     receive at least 1 cycle of study drug will be includes in the intention-to-treat (ITT)~     analysis.~      The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage~     design will be used to estimate the number of pts required. Out of 90 pts overall, with the~     first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole~     study population (80% power and a 2-sided test of significance at the 10% level).~      Correlative research on tissue/blood samples will include immune-cell profiling in tumor and~     blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples.~   "
24516|NCT02736253|"~     In this study, it was aimed to evaluate the independent risk factors for osteomyelitis,~     amputation and major amputation of the diabetic foot infection in the forward direction~     without using standard scoring procedures.~   "
24517|NCT02736240|"~     The purpose of this study is to investigate and valuate the immunogenicity and safety of the~     13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants~     and toddlers (the youngest could be 6 weeks old)~   "
24518|NCT02736227|"~     Most patients who get a liver transplant must take immunosuppressants for the rest of their~     lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic~     kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL)~     is a drug that may stabilize or improve kidney function for patients with chronic kidney~     disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care~     treatment to prevent transplant liver rejection in combination with other~     immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a~     combination of two different immunosuppressants and EVL to determine if patients may have~     stabilized and/or improved kidney function without liver rejection. This study will look at~     how safe it is to slowly withdraw one anti-rejection medication while continuing to take the~     other medicine, and whether this can be done without liver rejection occurrence.~   "
24519|NCT02736214|"~     Many women and men in fertile age are at risk for sexual transmitted infections and unwanted~     pregnancies, and have insufficient knowledge of health promoting lifestyle prior to~     conception. There is a need to increase awareness among people in fertile age about how~     sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy~     outcomes. Previous studies on preconception health and care have mainly focused on women.~     The aim of our study was to investigate if Reproductive Life Plan-based counseling with a~     midwife could increase men's reproductive knowledge. The second aim was to evaluate men's~     experiences of the intervention.~   "
24520|NCT02736201|"~     Objective: To determine the effectiveness of the capacitive diathermy in the~     mechanosensitivity, morphological, functional and contractility changes in patients with~     lumbopelvic pain.~      Design: A pilot study, single blind, randomized controlled clinical trial, approved~     previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the~     European University clinical intervention review board (CIPI/054/15).~      Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.~      Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between~     18 and 60 years old, will be recruited and randomized into 2 intervention groups. The~     instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+~     T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive~     diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1~     treatment per week during 10 minutes) in the lumbopelvic region.~      Outcome measurements: Control variables such as the age, sex, height, weight, body mass~     index, Borg scale physical activity and distress respiratory test will be measured at the~     beginning of the treatment. Dependent variables such as the pain intensity, the pressure~     pain threshold, the contractility, the stiffness, the adverse effects, the Oswestry and~     Schöber test, as well as the ultrasound imaging cross sectional area and thickness of the~     skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus~     anterior, externus oblique, internal oblique and transversus abdominis) will be assessed~     before and after each intervention by a blinded examiner.~      Analysis data: The statistical analysis will be performed with a 95% confidence interval and~     the Statistic Package Social Sciences (SPSS) 22.0.~   "
24521|NCT02736188|"~     This open-label extension study of Ace-ER will assess the long-term safety and efficacy of~     Ace-ER treatment over a period of 24 months. Approximately 165 subjects from the~     UX001-CL202, UX001-CL301 and UX001-CL203 studies will be eligible to enroll in the study.~   "
24522|NCT02736175|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical~     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular~     lens implantation.~   "
24523|NCT02736162|"~     The primary objective of this study is to assess the retention rate of perampanel when given~     as secondary monotherapy in routine clinical care.~   "
24524|NCT02736149|"~     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH)~     (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical~     worsening. This study is a Phase 2, open-label, multicenter, extension study to evaluate~     long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete~     Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind,~     placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002.~     The primary objective for this study is:~      - to obtain long-term safety and tolerability data for ubenimex (150 mg administered three~     times daily [TID]) in patients with PAH (WHO Group 1).~   "
24542|NCT02735915|"~     The purpose of this study is to evaluate the persistence of immune response to the HZ~     vaccine as well as safety up to 10 years after the first dose of initial vaccination course.~     This study will also assess immune responses after re-vaccination with 2 additional doses of~     the HZ/su administered at ten years after first dose of initial vaccination course from~     study Zoster-003 (NCT00434577).~   "
24529|NCT02736084|"~     The investigators developed a novel, telephone-based, 12-week positive psychology~     intervention and will assess its feasibility and short-term impact in adults with type 2~     diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a~     positive psychology (PP) manual, complete exercises (e.g., writing a gratitude letter,~     performing acts of kindness), and review these activities by phone with a study trainer over~     the 12-week study period.~      Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess~     whether PP exercises administered over the phone are feasible and linked with immediate~     benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.~      Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be~     completed by a majority of participants, and participants will have a mean score of at least~     7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also~     have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise~     and ratings of optimism post-exercise that are significantly higher than pre-exercise).~      Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP~     intervention is linked to improvements in psychological well-being, during and after the~     intervention period (6 & 12 weeks), via measures of optimism, gratitude, depression, and~     anxiety. To examine whether the brief PP intervention is associated with improvements in~     self-reported outcomes related to health (diabetes self-care, diabetes distress, health~     related quality of life), during and after the intervention.~      Hypothesis: Participants will have higher mean scores on all psychological outcome measures~     at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on~     all health-related outcome measures at 6 and 12 weeks compared to baseline.~   "
24530|NCT02736071|"~     Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into~     three equal groups. To ensure blinding the double dummy technique will be used in which~     group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib,~     group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group~     3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib.~     All the drugs will be given 2 hour before the procedure. An independent person will generate~     the allocation sequence using computer generated random numbers.~      Patient's perception of pain will be assessed for each group during the procedure,~     immediately after and 30 min after the procedure with the use of visual analogue scale~     (VAS).~   "
24531|NCT02736058|"~     Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly~     decrease the intra-operative complications as well as the maternal morbidity and mortality.~     In this trial researchers aim to set up some pre-operative sonographic criteria that would~     help in planning the surgical procedure as well as setting up a surgical classification for~     the abnormally adherent placenta.~   "
24532|NCT02736045|"~     Prior research has demonstrated that during residency years, in particular training to~     obtain a medical specialty, work burnout is a very prevalent problem. Work burnout is~     defined as a syndrome of dysfunction in three domains, emotional exhaustion,~     depersonalization, and a reduced sense of personal accomplishment. (Maslach et. al., 1981).~     Often, burnout has been associated with poor sleep quality and negative affectivity, such as~     depression and anxiety. In fact, our preliminary data demonstrate that burnout in medical~     residents affects sleep quality, and increases negative emotions. Strikingly, burnout in~     medical residents negatively impacts working performance as well as patient-physician~     interactions, and hence may affect the quality of health care. However, lacking are studies~     aimed at understating how work burnout affects cognitive performance and decision making in~     medical residents. The proposed study will provide essential groundwork in demonstrating the~     link between burnout and impaired cognitive performance. In addition, the proposed study~     will demonstrate feasibility for a future trial to test whether an intervention, emWave,~     integrating a computer based stress management (resilience training), can have a positive~     impact on residents with high burnout symptoms. The amelioration of psychological risk~     factors in medical residents may lead to improved physician-patient relationships in the~     service of improved quality of care.~   "
24533|NCT02736032|"~     Traditionally, the use of GnRH-a suppression was considered essential for adequate~     endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several~     studies, however, have questioned its necessity for controlled endometrial preparation.~     Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph,~     preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial~     preparation without GnRH-a.~   "
24534|NCT02736019|"~     Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and~     endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the~     investigators will use the double dummy technique in which group 1 will receive Tramadol~     100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to~     Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to~     a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a~     placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An~     independent person will generate the allocation sequence using computer generated random~     numbers.~      Patient's perception of pain will be assessed for each group during the procedure,~     immediately after and 30 min after the procedure with the use of visual analogue scale~     (VAS).~   "
24535|NCT02736006|"~     Diving disorders and particularly Decompression sickness (DCS) represent a major concern in~     recreational and occupational pressure-related activities. As a result of decompression from~     higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues~     take part in embolism then resulting in DCS. Individual factors such as vascular or~     respiratory defects are now considered to increase the risk of this dysbarism disease.~   "
24536|NCT02735993|"~     This cardiac registry study will collect information from patients with ischemic or~     non-ischemic heart failure that have been treated with adipose-derived regenerative cells~     (ADRCs) delivered via intramyocardial injection.~   "
24537|NCT02735980|"~     The purpose of this study is to evaluate the safety and efficacy of prexasertib when given~     to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study~     will evaluate how the body processes the drug and how the drug affects the body. The study~     will also evaluate the association between tumor response and the participant's perceived~     quality of life.~   "
24538|NCT02735967|"~     The aim of this study will be to evaluate the effects of the use of manual therapy and~     diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed~     with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain~     intensity and pain threshold the pressure.~   "
24539|NCT02735954|"~     To learn more about the positive and negative long term medical effects of marijuana use.~     Information obtained during this study may identify new markers that influence the~     development of lung diseases such as COPD. The Investigators are also interested in learning~     more about the effects of marijuana use for insomnia and how it may or may not affect sleep.~   "
24544|NCT02735889|"~     The objective of this study is to compare the effect of different levels of carbonation~     isocaloric beverages on glycemic response (using protocol based on standardized glycemic~     index testing methodology), gastric emptying and satiety. It is hypothesized that carbon~     dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance~     satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would~     have important health implications for the beverage industry.~   "
24545|NCT02735876|"~     This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1)~     versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or~     refractory (R/R) mantle cell lymphoma (MCL).~   "
24546|NCT02735863|"~     This study is a placebo-controlled study aimed at assessing the safety of ABX464~     administered at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are~     treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).~   "
24547|NCT02735850|"~     This will be a phase II trial testing if the combination of SBRT and L19-IL2 improves the~     progression free survival in patients with limited metastatic non-small cell lung cancer~     (NSCLC). Treatment will be divided in two cohorts: patients eligible for ablative~     stereotactic body radiotherapy to all metastatic sites (treatment with curative intent) and~     patients not eligible for stereotactic body radiotherapy to all sites (life prolongation).~   "
24548|NCT02735837|"~     Aim:~      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy~     plus subgingivally doxycycline gel 3% on glycemic control in type 2 diabetes mellitus (type~     2 DM) patients who have periodontitis.~      Materials and methods:~      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and~     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and~     type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More~     than 110 have), and also with periodontal disease are chronic moderate (at least in three~     areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by~     clinical examination and radiographic signs are being); Takes place. The initial HbA1c~     Patients should be between 7-9 percent over the past three months has changed his medication~     also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe &~     Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and~     its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded.~     Group 1: (12 patients) was treated with oral hygiene instruction, scaling and root~     planing, and doxycycline gel for 15 days; and Group 2: (12 patients) has the same~     treatment but with placebo gel, After 12 weeks their periodontal condition and Fasting blood~     sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.~   "
24549|NCT02735824|"~     Individuals with suspected primary immunodeficiency will be studied and the results compared~     with healthy controls. Primary immunodeficiency may manifest as recurrent, severe or unusual~     infections as well as signs and symptoms of immune dysregulation such as autoimmunity or~     lymphoproliferation.~   "
24550|NCT02735811|"~     Multicentric, observational, retrospective registry including patients underwent ICD~     implantation for any indication. The primary aim of the registry is to evaluate the~     long-term outcome of patients receiving an ICD.~   "
24551|NCT02735798|"~     This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with~     trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain~     metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR~     brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab~     given on day 1 of an every 21-day dosing cycle, at the recommended phase 2 dose of 30 mg/m2.~     Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) three hours after~     unlabeled dose of MM-302. Integrated MR/PET imaging of the brain and whole body will be~     performed at two time points following 64Cu-labeled MM-302 administration: (1) within 3~     hours (+/- 1 hour) of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection.~     Patients will continue to receive subsequent doses of unlabeled MM-302 plus trastuzumab~     every 3 weeks until clinical or radiographic disease progression (either in the brain or~     systemically) or unacceptable toxicity, whichever occurs soonest. MR brain imaging and~     FDG-PET/CT scans will be performed every 9 weeks to monitor for treatment response and~     disease progression.~   "
24552|NCT02735785|"~     The Harnessing Online Peer Education (HOPE) intervention combines social media with a~     psychology-based interventions to change behavior. This intervention is being applied to~     reduce prescription drug abuse among patients with chronic pain.~   "
24553|NCT02735772|"~     A new technique for Applying sutures to the white line in paravaginal repair.~   "
24554|NCT02735759|"~     The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry~     device and its use in detecting circulating emboli.~      Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the~     device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating~     emboli in vivo in patients with venous thromboembolism at diagnosis, during and after~     anticoagulation therapy.~   "
24555|NCT02735746|"~     The purpose of this study is to to compare lung function data generated by applying High~     Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic~     images of the lungs breathing to determine whether different modalities of imaging provide~     similar data on lung movement and function. HFFLI may detect changes in lung function in~     patients undergoing External Beam Radiotherapy for cancer.~   "
24556|NCT02735733|"~     To determine if a balloon tamponade catheter filled with cold saline is more effective than~     a catheter filled with room temperature saline in controlling post partum hemorrhage.~   "
24568|NCT02735577|"~     This study combines functional MRI with medication treatment in order to understand the~     neural mechanisms by which disulfiram, a currently approved medication for alcohol use~     disorder, changes behavior. Disulfiram is a medication that prevents drinking by causing a~     highly unpleasant physical reaction when alcohol is consumed while it is being taken. Thus,~     it provides a means for studying the general neural mechanisms by which awareness of risks~     impacts behavior change in alcohol use disorder.~   "
24990|NCT02730104|"~     The purpose of this trial is to assess time to disease progression of patients with locally~     advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide~     Depot. This is an observational study therefore all data collected will be in accordance~     with the routine practice of physicians.~   "
24557|NCT02735720|"~     The use of TEVAR is increasing rapidly and patients even in younger patients. However,~     current endografts are several orders of magnitude stiffer than the native aorta.~     Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR~     resulting in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary~     perfusion, and finally, heart failure. These effects are markedly profound in young~     patients, as their hearts and aortas are more compliant. Previous studies on adverse~     cardiovascular remodeling have important limitations, such as retrospective design, use of~     echocardiography (with low reproducibility and high operator-dependency), and mixed~     populations. A systematic assessment of the deleterious effects of TEVAR is still missing.~      The objective of this study is to perform a prospective, non-randomized controlled, study in~     which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic~     assessment, computational modeling and biomarkers are used to assess cardiovascular~     remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA)~     or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA~     and PAU subjects who do not require endovascular treatment.~      The specific aims of the study include: 1) Quantification of cardiovascular remodeling~     following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic~     aortic hemodynamics following TEVAR using the above clinical measurements. Once validated,~     computational analyses will be performed to virtually assess the impact of more compliant~     endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of~     ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference~     method.~      This study will assess the impact of thoracic aortic stent grafts on the cardiovascular~     system through non-invasive measurements. Although there are no direct benefits for the~     enrolled subjects, future aortic patients might benefit from better patient management with~     improved aortic endograft designs and long-term outcomes.~   "
24558|NCT02735707|"~     Randomized Embedded, Multifactorial, Adaptive Platform (REMAP) trial in patients with severe~     community acquired pneumonia (CAP) admitted to an ICU.~   "
24559|NCT02735694|"~     This study is being conducted to determine whether cycloserine is effective for the~     treatment of sleep apnea. Cycloserine is an antibiotic that has been extensively used in the~     treatment tuberculosis. However, more recently it was shown to enhance memory responses.~     Cycloserine may enhance the response of respiratory muscles to apnea and potentially reduce~     the severity of sleep disordered breathing.~   "
24560|NCT02735681|"~     Meibomian glands (MG) are modified sebaceous glands associated with the tarsus (collagenous~     structural component) of the upper and lower eyelids. Meibomian glands produce lipid-based~     secretions which are an integral and stabilizing part of the tear film. In blepharitis and~     ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-MGD),~     inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in~     glandular secretions, and dropout of the glands themselves. This limits the production,~     secretion, and quality of meibum. With less oil in the tear film, the aqueous portion of~     tears is not stable and evaporates quickly which leads to dry eye.~   "
24561|NCT02735668|"~     The main objective of the study is to determine whether the invasive physical therapy and~     motor control exercises of shoulder joint together are more effective than motor control~     exercises of shoulder joint and/or shoulder conventional exercises.~   "
24562|NCT02735655|"~     This is a 10 minutes web based survey aims at exploring the current, global state of~     digestive endoscopy training among physicians to identify what are the unmet needs and how~     to improve it.~   "
24563|NCT02735642|"~     Knowledge of HIV status is a first step towards accessing HIV care, treatment, and~     prevention services.The GIRLS study will rigorously compare two 'seek' recruitment~     strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial~     design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa~     Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention~     messaging intervention to support identified HIV-negative young women in reducing HIV risk~     and adhering to recommended HIV re-testing recommendations. We will also conduct an economic~     evaluation, using cost effectiveness analyses to determine the relative utility of each~     seek, test, link, and prevention interventions.~      Lessons learned will inform Government of Kenya, and other key policymakers, implementing~     partners and agencies throughout sub-Saharan Africa that are exploring policies about~     appropriate scale up of these multiple seek, test, link, retain, and prevention strategies~     to realize the dream of an AIDS-free future for adolescent girls and young women.~   "
24564|NCT02735629|"~     The study is an investigation to assess the capacity of ascending doses of CX1739 to~     antagonize the respiratory depressive effect of remifentanil. The study will also~     investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or~     alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in~     conjunction with remifentanil.~   "
24565|NCT02735616|"~     By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it~     to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals:~      1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the~     sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of~     heart rate along 3 days between patients after stroke in the sub-acute phase and control~     group matched by age and gender. 3. To describe the reaction and examine the differences in~     reactions of the heart autonomic system during rest, paced breathing and activity in both~     groups- stoke and control.~      The HRV will be monitored by Polar watch and the activity will be measured by accelerometer,~     both will be attached to the patients at the beginning of the trial and will stay on them~     for 3 whole days.~   "
24566|NCT02735603|"~     The purpose of this study is to evaluate the potential effect of naltrexone and bupropion~     extended-release combination on cardiac repolarization in healthy participants.~   "
24567|NCT02735590|"~     Effective tuberculosis (TB) control requires that people who progress from latent~     Mycobacterium tuberculosis (MTB) infection (LTBI) to TB disease are identified and treated~     before they infect others. A prognostic correlate of risk (COR), based on messenger~     ribonucleic acid (mRNA) expression signatures, which prospectively discriminates between TB~     cases and healthy controls, has been constructed and validated. Based on published~     microarray case-control datasets, the COR has 87% diagnostic sensitivity and 97% specificity~     for prevalent TB disease; and in two nested case-control studies, 70% prognostic sensitivity~     and 84% specificity for incident TB disease occurring within one year of sampling (HIV~     uninfected persons). Diagnostic and prognostic performance of the COR has not yet been~     tested in a prospective cohort.~      COR+ status is not directly associated with LTBI; and may, or may not, be amenable to~     preventive therapy. Although effective in the short-term, preventive therapy is not~     recommended for treatment of LTBI in HIV uninfected adults living in high TB burden~     countries, due to rapid loss of protection; and treatment burden. A 3-month, 12-dose,~     once-weekly preventive therapy regimen of high dose Isoniazid (INH) and Rifapentine (3HP)~     has been recommended as equivalent to 6 months of daily INH for treatment of LTBI in low TB~     burden countries by the World Health Organization (WHO).~      A 'screen & treat' strategy, based on serial mass campaigns to provide targeted,~     short-course preventive therapy only to COR+ persons at highest risk of TB disease, may~     offer the solution for durable, community-wide protection in high TB burden countries. The~     efficacy of 3HP for prevention of incident TB disease in COR+ persons has not yet been~     tested in a clinical trial.~      Primary Aims~        1. Test whether preventive therapy (3HP) reduces the rate of incident TB disease, compared~          to standard of care (active surveillance), in COR+ persons.~        2. Test whether COR status differentiates persons with cumulative prevalent or incident TB~          disease from persons without TB disease.~      Secondary Aims~        1. Estimate whether COR status differentiates persons at high risk for incident TB disease~          from persons at low risk for incident TB disease~        2. Compare prognostic performance of the COR for incident TB disease with Interferon-gamma~          release assay (IGRA).~   "
24569|NCT02735564|"~     Bariatric surgery is considered an effective long-term intervention for the treatment of~     obesity and associated complications. While bariatric surgery has been shown to result in a~     large sustained weight loss, the degree of weight loss and maintenance thereafter varies~     greatly. The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project~     examining weight loss after an intensive medical intervention (IMI) and the 2 most widely~     used bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG).~     Baseline data are collected prior to surgery and follow-up data are collected at 6 months~     and annually thereafter. A recent meta-analysis revealed that RYGB resulted in greater~     weight loss and is more effective in resolving obesity related comorbidities than SG,~     although SG has been shown to result in a reduction of perioperative complications and~     reoperations1. Full elucidation of the mechanisms leading to variation in success for weight~     loss interventions is crucial to understanding the most effective and reliable treatments~     for obesity and associated comorbidities.~   "
24570|NCT02735551|"~     This prospective randomized controlled study will evaluate if Long Acting Reversible~     Contraceptive (LARC) forward counseling in combination with same-day LARC placement~     increases overall LARC uptake within a community college population compared to LARC forward~     counseling and referral to a secondary clinic for LARC placement. The study will be~     conducted at Mount Hood Community College (MHCC) in Oregon. Participants will be enrolled~     into three groups. All groups will receive the same standardized contraceptive counseling~     (LARC forward counseling) and participants will be able to choose between a LARC method~     and short-acting method of birth control.~   "
24571|NCT02735538|"~     The trial detected mRNA expression of several bone repair-related genes, including Runx2, in~     the femoral head and neck of patients with osteonecrosis of femoral head (ONFH) . Runx2~     expression was compared with that of identical tissue from osteoarthritis patients to~     identify expression in necrotic femoral head tissue, which will help clarify the role and~     possible clinical significance of Runx2 in femoral head necrosis, bone repair and~     reconstruction.~   "
24572|NCT02735525|"~     The proposed trial is a pilot to test a smartphone application (app) that will ultimately~     allow patients to take and transmit photos of their postoperative wounds from home and relay~     other symptom information. This protocol covers the single-institution pilot study of the~     app's use in the period between hospital discharge and a patient's first follow-up clinic~     visit. The investigators will recruit vascular surgery patients either preoperatively in~     clinic or in the post-operative, pre-discharge period following surgery to participate in~     the pilot. Using a training protocol refined in the usability-testing phase of the project,~     patients will be trained to use the smartphone and the wound surveillance app prior to~     discharge. Patients will use the app from home to take send digital images of their~     postoperative wounds and answer a short survey, all of which will be transmitted to a secure~     database maintained by the University of Wisconsin (UW) Department of Surgery and accessible~     only to UW-employed study personnel. These data will be evaluated by one of three vascular~     surgery service nurse practitioners (NPs) daily and entered into the medical record.~     Patients who have concerning findings either in their images or in their survey answers will~     be contacted for further evaluation. Smartphones will be provided to patients who do not~     have one of their own, through a partnership with AT&T. Sociodemographic and comorbidity~     data collected from the medical record will be kept at UW Department of Surgery on a secure~     server and accessible only to UW employed study personnel.~   "
24573|NCT02735512|"~     This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical~     assay works in finding and monitoring cancer cells in blood and urine samples from patients~     with or without localized or metastatic bladder cancer. Studying samples of blood and urine~     from patients with or without bladder cancer in the laboratory may help doctors identify and~     learn more about biomarkers related to cancer and may help doctors improve ways to diagnose~     and treat patients.~   "
24574|NCT02735499|"~     Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder~   "
24575|NCT02735486|"~     The primary aim of the study was to investigate the acute effect of ginger drink consumption~     on the risk markers of cardiovascular disease.~   "
24576|NCT02735473|"~     This is a randomized, double-blind, placebo-controlled trial of choline supplementation in~     children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are~     cognitive measures.~   "
24577|NCT02735460|"~     Andago V2.0 is a recently developed overground gait and balance training device. Many~     patients in neurorehabilitation suffer from gait disorders, most typically after stroke.~     Since pharmacological therapies are basically not available, neurorehabilitation plays an~     important role in the treatment of such patients. The Andago V2.0 may represent a useful~     device in the rehabilitation of stroke and other neurological patients featuring a severe~     gait disorder. Therefore a study has been designed to investigate the usability of the~     Andago V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this~     study are the usability and acceptance of the investigational medical device (IMD).~     Usability is mainly measured by the time spent for the set-up and release of the~     participant, achieved training times and distances, the number of stumbles, collisions and~     emergency stops and the error messages during the session. Besides patient and therapist~     satisfaction with the Andago V2.0 is recorded.~   "
24585|NCT02735356|"~     This phase 0 trial studies how well itraconazole gel works in treating patients with basal~     cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.~   "
24586|NCT02735343|"~     Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in~     the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard~     treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2~     (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will~     be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood~     Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and~     Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess~     their pain and assess their satisfaction with their migraine pain management as part of this~     study. Subjects' participation will last up to 48 hours post headache.~   "
24587|NCT02735330|"~     To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with~     Frey's procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in~     a single centre setting with a Randomized Controlled Trial.~   "
24578|NCT02735447|"~     Sporadic inclusion body myositis (sIBM) is a rare idiopathic inflammatory myopathy~     characterized by chronic proximal leg and distal arm asymmetric muscle weakness. Its~     prevalence is estimated between 10 and 100 cases per million, over the age of 50. Little is~     known about the natural course of the disease, the delay between onset and diagnosis, the~     patterns of disease management and treatment in routine practice, as well as the burden for~     patients.~      The objectives of the PGRx-sIBM study will be to describe:~        -  The epidemiology of the disease (estimation of the prevalence, age at onset, delay~          between onset and diagnosis, diagnosis process, etc.)~        -  The patterns of disease management and treatment in routine practice~        -  The burden of the disease for patients and their informal caregiver, as well as the~          quality of life of patients~        -  The burden of the disease for informal caregivers~      This will be an observational (non-interventional), cross-sectional (transversal) study.~      Study setting The PGRx-sIBM will take place in France, Italy, Switzerland and Spain.~     Recruitment centers will be public and private practices and hospitals from urban or rural~     areas. In each recruitment center, at least one physician will act as a study investigator,~     in charge of identifying and recruiting patients.~      Inclusion of patients~      Patients will be included by their specialized physician (neurologist, Internal Medicine)~     during a regular outpatient visit, provided that they meet the following inclusion criteria:~        -  The patient has been diagnosed with sIBM, as per the physician judgement and regardless~          of the date of diagnosis~        -  Male or female~        -  Age ≥ 45 years old~        -  The patient does regularly live in the country of inclusion~        -  The patient or his/her proxy can read and respond to a telephone interview~        -  The patient agrees to participate~      Exclusion criteria will be:~        -  The patient refuses to participate or the written Consent Form is not signed~        -  The patient or his/her proxy cannot be reached by telephone. All eligible patients will~          be invited to participate in the study, during a 3 to 6-month period of time.~      The target sample size will be of 190 patients (≈15-20 in Switzerland, ≈50 in Spain, ≈50 in~     Italy and ≈70-75 in France).~   "
24579|NCT02735434|"~     Health anxiety is a prevalent, disabling disorder associated with extensive health care~     expenditures. The lack of easily accessible, evidence-based psychological treatment combined~     with delayed diagnostic recognition constitute barriers to receiving treatment.~      Aim~        1. To develop an internet-delivered treatment program, based on 'Acceptance and Commitment~          Therapy' (ACT), for patients with health anxiety.~        2. To test the feasibility and effectiveness of the treatment programme in a randomized,~          controlled trial, comparing the treatment with an active control condition.~      Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for~     participation. Before inclusion patients will undergo a video-diagnostic interview. Patients~     are randomly assigned to 12 weeks of either, 1) active treatment: consisting of~     internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises,~     patient videos and audio-files, or 2) active control condition: consisting of an~     internet-based discussion forum (iFORUM) with 7 topics of discussion.~      All patients will complete self-report questionnaires at baseline, before randomization, at~     4 and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.~   "
24580|NCT02735421|"~     This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using~     intra-individual comparison (right half-face versus left half-face).~      Subjects will have each half-face randomized to one of the two following treatments:~        -  Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).~        -  Vehicle gel~      The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl~     peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars~     in moderate to severe acne subjects.~   "
24581|NCT02735408|"~     Lumbar pain is a quite prevalent pathology in general population within general and sporting~     population, which comes to mean high sanitary and sport costs. This concrete pain´s nature~     is often unspecific, but it seems that one of the main risk factors that predispose to~     suffer from it are changes in the paravertebral-lumbar musculature stiffness.~      Since one decade approximately, it has proliferated, especially within sportsmen and women~     the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape~     (KT). This treatment seems to accept different applications, despite there´s still a lack of~     scientific evidence for several of its supposed effects. One of the theories about its use~     technique is that the bandage strain generates different effects in musculature stiffness.~     Thus, when the bandage is applied over the skin with a pre-stretching of the elastic~     bandage, it can cause arise of stiffness and strength muscle empowerment. On the other hand,~     if the bandage is applied without strain, the opposite result would appear, relaxation and~     strength muscle decrease.~      For trainers and therapists is important to know if the KT effect differs over the bandage~     technique, since the application could be different according to the specific troubles~     reported by the athletes. For example, talking about cyclists, who keep constantly a hold~     rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness,~     by placing the bandage with certain strain to achieve a mechanic effect. Nevertheless,~     talking about other sports like weightlifting, the bandage effect should be the stiffness~     arisen as a preventive measure, for avoiding injuries derived from the lack of motor control~     in the lumbar region. These lumbar-region muscle problems affect to popular and majority~     sports like football, so lumbar pain is very frequently reported by football players,~     normally due to an agonist-antagonist musculature unbalance. In all these terms, the use of~     KT would be interesting in order to reduce the musculature strain degree.~      Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the~     musculature stiffness assessing, due to its velocity, harmlessness, sensing and high~     reproducibility. Taking in consideration that the maximum deformity measured by the TMG is~     inversely related with the muscle stiffness, and whereas this project pretends to modify~     that stiffness by means of the KT application, it seems obvious that TMG is the most~     suitable measurement instrument.~      All these precedents considered, the present project pretends to analyze the effects of~     different KT strain application along 48 hours with strains techniques of 100%, strain 50%~     and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by~     means of TMG monitoring.~   "
24582|NCT02735395|"~     The aim of this study was to compare the clinical and microbiological outcomes of different~     dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and~     amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized~     chronic periodontitis (GChP).~   "
24583|NCT02735382|"~     This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based,~     closed-loop referrals for tobacco cessation from primary care clinics to a state telephone~     tobacco quitline can increase the number/percentage of adult tobacco users receiving~     evidence-based tobacco dependence treatment when compared to paper-based fax referrals.~   "
24584|NCT02735369|"~     The present study is intended to evaluate the efficacy and safety of topical OC-10X~     Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level~     61, 65, 71, or 75). OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound,~     known as OC-10X, which is a selective tubulin inhibitor under development for the treatment~     of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When~     administered as a topical eye drop, OC-10X has both anti-angiogenic (inhibition) and~     angiolytic (regression) properties in animal models of choroidal neovascularization (CNV).~     Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without~     the traditional toxicity and works downstream independently of growth factors. As~     demonstrated by OcuCure's preclinical data, tubulin inhibition, using OC-10X, may be a~     promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of~     blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly,~     the Phase I Study found that OC-10X can be safely applied topically in human eyes without~     adverse ocular or systemic effects.~      Currently, there are few options for the treatment of PDR. Clinical options, such as laser~     photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision.~     With few treatment options available, administration of OC-10X as a topical therapy, along~     with its novel mechanism, has the potential to provide benefits to patients with ocular~     diseases associated with angiogenesis.~   "
24588|NCT02735317|"~     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The~     most frequently occurred radiation-related side effect is probably the radiation-induced~     oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy.~     When severe, oral mucositis increases the risk of infection and may compromise clinical~     outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy~     compliance. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin~     B12, and procaine, is commonly prescribed when NPC patients begin to suffer from~     radiation-induced OM. However, the incidence of radiation-induced OM is still quite high.~     Oral Ulcer Gargle (FORRAD®) is a proprietary viscous liquid mucoadhesive hydrogel~     formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure~     radiation-induced OM. The objective of this randomized phase II study is to assess the~     efficacy and safety of Oral Ulcer Gargle (FORRAD®) as an intervention for radiation-induced~     OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is~     composed of dexamethasone, gentamicin, vitamin B12, and procaine.~   "
24589|NCT02735304|"~     This clinical study seeks to address four independent questions that are all part of the~     delivery of care associated with the provision of a single item of treatment; an indirect~     restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a~     crown requires a series of sequential clinical and laboratory stages stages:~        1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be~          crowned. This will be used to enable the fabrication of the temporary crown after the~          tooth has been prepared. This is standard care and follows established clinical~          protocols.~        2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space~          for the crown that will be fabricated to replace the missing structure.~        3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will~          be made to fabricate the crown. To take the impression, the dentist will need to gently~          push the gums away from the tooth by fractions of a millimeter so that the margins of~          the preparation are clearly discernible.~        4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function~          for a limited period of time, until the definitive crown can be fitted. This temporary~          crown is designed to have a finite short-term durability and have an ease of~          manufacture and subsequent removal; hence the use of a specific cement that will enable~          this.~        5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable~          restoration, with a mean life expectancy measured in years, but which is ultimately~          determined by a number of clinical, biological and patient specific parameters.~          Definitive restorations are fitted with cement designed to retain the crown in~          permanent manner.~   "
24590|NCT02735291|"~     This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or~     refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells~     that have been genetically modified to express a chimeric antigen receptor (CAR) that will~     bind to tumour cells that express the EPCAM protein on the cell surface.The study will~     determine if these modified T cells help the body's immune system eliminate tumour cells.The~     trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the~     patient's body and the impact of this treatment on survival.~   "
24591|NCT02735278|"~     In optometry, binocular coordination is measured subjectively. The result is subjective~     fixation disparity. In research different experiments have proven, that subjective and~     objective fixation disparity are different. A binocular eyetracker has to be calibrated.~     There are two well known calibration methods: associated and dissociated calibration.~     Objective fixation disparity is measured in arcMin. Therefore, the precision of the~     eyetracker plays a crucial role. Now, the investigators try to compare dissociated~     calibration with polarized filters and associated calibration under different test~     paradigms.~   "
24592|NCT02735265|"~     Virtual reality balance training has already been used in stroke rehabilitation, and~     previous studies supported that could improve balance ability. Although the treatment~     effects were supported in studies, there are still limitations in clinical intervention and~     the study power is not enough.~      Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60~     patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly~     assign participants to standard treatment plus virtual reality group (N=30) and standard~     treatment only group (N=30). There are total 12 sessions (2 times weekly) for both groups.~     Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow~     up in post 3 month).Investigators will also record the pleasure scale and adverse event~     after every training session. Hypothesis is that Kinect for Xbox intervention can~     significantly improve subjects' balance ability, confidence of balance, ADL, and QOL~     compared to the conventional rehabilitation. It may help to develop a new clinical model of~     virtual reality training for patients with chronic stroke.~   "
24593|NCT02735252|"~     This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic~     prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion~     will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be~     enrolled in parallel into one of five patient cohorts based modality of planned or recently~     initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor,~     (B) Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive~     disease. Patients in cohort E will be enrolled in one of two groups: Group 1~     (treatment-naïve), and Group 2 (pre-treated) (see previous section for definition). Patients~     enrolled in Cohorts A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy~     prior to initiation of next line of systemic therapy. For patients enrolled in Cohort E,~     group 2, patients will undergo the first tumor biopsy between 6-8 months after first dose of~     LHRH analogue delivered as treatment for metastatic prostate cancer.~   "
24594|NCT02735239|"~     This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in~     combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced~     oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable~     OC. The immunotherapy will be given for a 4-week period before starting the standard~     chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study~     will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2~     (Cohorts B, C, and D).~   "
24603|NCT02735122|"~     This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of~     1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial~     products of acetaminophen 1000 mg administered as two 500 mg tablets, and ibuprofen (IBU)~     400 mg following third molar (wisdom tooth) extraction.~   "
24873|NCT02731612|"~     This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to~     assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression)~     who are in remission from an episode. Participants who show cognitive impairment at the~     screening visit will be enrolled into the study and randomized at the baseline visit to~     receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.~   "
24595|NCT02735226|"~     The Shanghai Stroke Service System（4S） has been established as the network of stroke care in~     greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and~     their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of~     40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that~     emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the~     effort of recovery and secondary stroke prevention. The novel electronic data aquisition~     system provides the contiguous data of clinical care of stroke patients from the acute phase~     of management to inpatient rehabilitation. This system has been implemented and maintained~     as an ongoing quality of stroke care project that monitored the process of routine stroke~     care in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family~     Planning. Our analysis of the project was approved by the Ethics Committee, which agreed~     that no written informed consents were needed since the study only was consisted of a~     population-based retrospective data analysis.~   "
24596|NCT02735213|"~     The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to~     traditional laser therapy in central serous chorioretinopathy.~   "
24597|NCT02735200|"~     After obtaining the approval from the IRB of University of Dammam and informed consent from~     550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency~     were recruited. Age, weight and height will be taken, a detailed history, meticulous~     clinical examination was performed to rule out any diseases and complete blood picture,~     serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D~     (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence~     immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20~     ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and~     200 in control arm. All participants were instructed not to change their dietary habits and~     life style till the study was over. The study group of women were instructed to apply to~     apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The~     second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group~     they belong. A second blood sample was taken at the end of 4 months and the data was entered~     in the data base and analyzed using SPSS Inc version 19.~   "
24598|NCT02735187|"~     Patients will be screened up to 28 days before start of treatment. During the screening~     visit, the purpose and procedures of the study will be explained to potential patients and~     informed consent will be obtained.~      At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible~     patients will be randomized to treatment of the target area with either 30 minutes (group30)~     or 15 minutes (group15) blue light at 600 mW/cm². Additionally, two study areas with similar~     clinical symptomatology will be determined and will be randomized to blue light treated area~     and Daivonex treated area.~      After randomization, patients will be trained on a demonstrator device (no actual treatment~     to ensure investigator is blinded as to which group the patient is randomized to) as well as~     the Daivonex cream. After patients have been instructed, treatment of the areas will be~     applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks.~     During those 12 weeks, patients will return to the study site for safety and effectiveness~     assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week~     of treatment to check for any adverse events or problems in handling the device or the~     cream. The visit at week 12 serves as end of treatment visit. The patients will be~     followed-up for another 4 weeks. Treatment responses will be photo documented.~   "
24599|NCT02735174|"~     This is a pilot study to improve the partnership between Cincinnati Children's Medical~     Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to~     reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling~     this project asthma-free schools and bringing it to neighborhoods where the incidence of~     asthma is especially high. We have designed this study to work with school-based asthma care~     programs. Children with high-risk asthma will be asked to participate. High-risk will be~     defined as poorly controlled asthma, frequent school absences, and/or need for daily~     controller asthma medications. We will use a commercially available inhaler cap sensor to~     help track medication use and symptoms through a smartphone. The study visits will be done~     mostly at the school using telehealth technology similar to Skype.~   "
24600|NCT02735161|"~     The aims of the current study is to explore if different exercise training protocols affect~     fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal~     cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training~     period.~   "
24601|NCT02735148|"~     Stroke is one of the most common causes of acquired adult disability. The majority of stroke~     survivors have mobility difficulties such as poor standing, decreased walking speed, balance~     disturbances, and increased risk for falls. Improving mobility, functional walking and~     balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more~     promising intervention for the locomotor training in stroke rehabilitation. Static or~     dynamic balance deficits act crucial role on gait performance among stroke survivors.~     Therefore it is important to determine the effects of BWSTT in improving balance in persons~     with stroke. Although it has been demonstrated that BWSTT improved balance and gait~     performance in stroke patients, it is not clear whether the improvements are greater~     compared with those associated with other gait rehabilitation methods. To the investigators~     knowledge, there are also limited studies in the literature concerning the effects of BWSTT~     on falling risk in stroke patients. The strong evidence is needed about the effectiveness of~     BWSTT including comprehensive determinants of balance with combined and isolated~     intervention groups.This study aims to compare the effects of BWSTT with combined and~     isolated intervention on balance, gait and fall risk in patients with subacute and chronic~     stroke. The investigators hypotheses are that after stroke:~        1. the combination of BWSTT with conventional training may lead to more improved balance~          parameters;~        2. when applied as an isolated intervention, BWSTT or conventional training may lead to~          similar results.~   "
24602|NCT02735135|"~     The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant~     pressure mattresses in terms of peak skin pressures measured at the sacral area.~   "
24615|NCT02734966|"~     The purpose of this study is to investigate the safety, effective dosage and treatment of~     Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared~     with the Tiopronin Injection.~   "
24604|NCT02735109|"~     The confocal microscope is a noninvasive imaging technique that provides high-resolution~     images to a depth of 250 microns, such as optical cuts in three dimensions in the~     thickness of the skin.~      This is a single-center prospective descriptive study at the University Hospital of Nice in~     gynecology and dermatology.~      The aim of the study is to describe the characteristics reproducibly for confocal microscope~     of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.~      The patients seen in consultation with vulvar lesions suspicious looking will be included.~      The results will be compared systematically to the histological results of biopsies of~     lesions (gold standard).~   "
24605|NCT02735096|"~     The human body uses vestibular feedback in coordination with visual and somatosensory~     information to maintain balance and posture. However, various inner-ear disorders due to~     aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular~     feedback, which makes it difficult for an individual to maintain balance. This study~     investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by~     Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral~     electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory~     feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by~     applying small and controlled electrical pulses at precise locations on the palatal surface~     according to an encoded pattern. This pilot study is to determine how this alternative~     sensory feedback on the roof of the mouth can be used to improve balance for patients with~     vestibular loss.~   "
24606|NCT02735083|"~     The purpose of this study is to evaluate the long-term safety and efficacy of UCART 19~     administration to patients with advanced lymphoid malignancies.~   "
24607|NCT02735070|"~     The primary objective of this study is to evaluate the non-inferiority of Coristina® d in~     the symptomatic treatment of the common cold compared to Resfenol® comparator.~   "
24608|NCT02735057|"~     Management of elderly patient with cancer is a therapeutic challenge and a public health~     problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women~     respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other~     70 % are considered unfit for surgery for various reasons, including ageing.~      Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for~     surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5~     weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and~     life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 %~     respectively, in patients with a median age of 64 years. CRT has not been properly evaluated~     in patients more than 75 years, and other combined chemotherapy are challenging.~   "
24609|NCT02735044|"~     Primary Objective:~      To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)~      Secondary Objectives:~        -  To compare HOE901-U300 and Lantus in terms of:~        -  Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).~        -  To assess the safety of HOE901-U300 including analysis of events of hypoglycemia,~          events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.~   "
24610|NCT02735031|"~     Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect~     hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes~     a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the~     end-result of a process of habituation to recurrent hypoglycemia that is potentially~     reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in~     addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with~     type 1 diabetes. This study will test the hypothesis that treatment with the GLP-1RA,~     exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in~     patients with type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled~     cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after~     which hypoglycemic symptoms and counterregulatory hormone responses will be examined during~     a hyperinsulinemic hypoglycemic glucose clamp study.~   "
24611|NCT02735018|"~     The study aim to evaluate systemic response of patients when 2 different concentrations of~     Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.~   "
24612|NCT02735005|"~     Heterogeneous modalities of aging lead to describe three categories of elderly patients:~     1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and~     frailty. Frail people have a high risk of losing functional independence and as a~     consequence they require more help for day to day life. It is known in elderly that physical~     activities, nutrition, social environment are important to maintain functional independence.~      For patients with disabilities, less is known about the occurence of dependance with aging.~     That is of growing importance because life expectancy of disabled patients has increased a~     lot during last decades, and because caregivers, often parents, also become elderly and~     frail.~      So the investigators will require tools to anticipate prevention and supportive needs for~     this specific population.~      The goal of this study is to evaluate if the participants (disabled patients over 40 years~     old) of a well-defined region in the south-east of France (400000 inhabitants), and to~     assess their needs, using the Functional Autonomy Measurement System (SMAF) developed for~     assessment of the elderly, by Rejean Hebert & Nicole Dubuc's team in Sherbrooke University~     (Quebec/Canada).~   "
24613|NCT02734992|"~     Research to date suggests that individuals with headache use avoidance as a way to manage~     their pain. Despite the wide use of avoidance as a coping mechanism of headache triggers,~     very little empirical evidence exist to support its effectiveness in headache management.~     New treatment approaches, such as Acceptance and Commitment Therapy (ACT), emphasize~     acceptance of headache and valued-living as alternatives to avoidance, have demonstrated~     preliminary support in helping individuals reduce headache-related disability and improve~     quality of life. Though, ACT has received empirical support for various chronic pain~     conditions, very little evidence exists as to its effectiveness for head pain problems. The~     current study will examine the effects of an ACT-based intervention when added to medical~     treatment as usual (MTAU) vs. a wait list control group comprised only of MTAU, on improving~     quality of life and decreasing disability among headache sufferers.~   "
24614|NCT02734979|"~     To investigate whether addition of the Biobridge scaffold to the standard surgery for~     vascularized lymph node transfer will improve the outcome of surgical treatment in~     lymphedema of the upper arm.~   "
24616|NCT02734953|"~     Pulmonary hypertension is characterized by an increase in the pressures in the blood supply~     to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall~     pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary~     vasculature, PVR will increase with exercise instead of decreasing as it would in normal~     patients. Based on published evidence, the investigators intend to investigate the effects~     of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have~     separately and previously had an implanted pulmonary artery monitoring device (CardioMems by~     St Jude Medical, Inc.) placed.~   "
24617|NCT02734940|"~     The investigators objective is to assess the effectiveness of an opioid sparing multimodal~     approach for enhancing the recovery in Cardiac Surgical patients. This model would use a~     combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine)~     drugs.~   "
24618|NCT02734927|"~     In order to control a behaviour, investigators need to realise goal directed actions and to~     priories some actions. This control is required in unusual situation. Appropriate actions~     are selected and coordinated according to context and aim.~      Several studies try to draw a model of executive function. Recently, Koechlin has suggested~     a three levelled organisation to explain how the prefrontal cortex controls actions.~      Contextual control is useful to answer appropriately with the immediate context. Episodic~     control allows selecting the action according to specific information given before.~     Sensorial control is the automatic response when a stimulus is presented.~      Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal~     cortex. Chambon and al (2008) have identified a dysfunction of contextual control in~     schizophrenia.~      As the prefrontal cortex is involved in motivational process, it seems interesting to study~     potential links between executive function and motivation. A study from Kouneiher shows~     contextual and episodic activation of motivation in healthy population.~      Investigators aim to study the way motivational process are recruited in schizophrenia.~   "
24619|NCT02734914|"~     This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS)~     with automatic control of renal pelvic pressure for the treatment of upper urinary calculi~     using a prospective, randomized design. Half of participants will receive suctioning~     flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half~     participants will receive retrograde intrarenal surgery using the classic flexible~     ureteroscopy.~   "
24620|NCT02734901|"~     Accumulating evidence from epidemiological and human intervention studies indicates that the~     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related~     to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds,~     in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At~     present, a small number of randomized controlled trials investigating the effects of berry~     (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown~     promising results. However, to date, very few human studies have specifically investigated~     the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects.~     Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time~     in the blood and urine. Therefore, the investigators will investigate the presence of plasma~     and urinary raspberry-derived metabolites 24h post-consumption. To the investigators~     knowledge, the effects of red raspberry consumption on vascular function in humans have not~     been investigated before. This information is necessary for the planning of long-term~     studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this~     study aims to investigate the potential role of red raspberry (poly)phenols in the~     modulation of vascular function by monitoring changes in vascular function together with the~     major (poly)phenol derivatives/metabolites in plasma.~   "
24621|NCT02734888|"~     Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2)~     Tobacco cigarette smokers, 3) Electronic cigarette users.~   "
24622|NCT02734875|"~     This stepped wedge randomized intervention will apply machine learning algorithms in an~     electronic health record system to identify primary care patients with non-valvular atrial~     fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An~     Anticoagulant Management Service (AMS) will offer support to primary care providers~     regarding treatment for relevant patients (either warfarin and novel oral anticoagulants).~      This study seeks to:~        1. increase the proportion of appropriately anticoagulated patients with AF,~        2. understand the reasons for lack of anticoagulation, and~        3. document the proportion of patients with AF who are appropriately not anticoagulated~          (e.g. patient refusal, contraindication).~   "
24623|NCT02734862|"~     The purpose of this study is to determine if intravenous CD101 is safe and effective in the~     treatment of candidemia when compared to caspofungin (followed by oral fluconazole).~   "
24624|NCT02734849|"~     This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.~     Pharmacodynamic activity will also be evaluated.~   "
24625|NCT02734836|"~     This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in~     patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant~     stenosis). 20 patients will be enrolled if they have claudication and/or critical limb~     ischemia, and identifiable SFA disease on angiogram requiring percutaneous peripheral~     intervention (PPI). We would like to study the vessel apposition and expansion immediately~     after initial implantation as well as evaluation of late stent malapposition and neointimal~     hyperplasia at the 12 months follow up after Zilver PTXTM stent implantation using~     intravascular OCT imaging. Follow up visits will take place at 1 month, 6 month, 12 month~     and 13 month after the procedure.~   "
24626|NCT02734823|"~     This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy~     on ovarian reserve and fertility in patients with chronic myeloid leukemia or~     gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone~     levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more~     about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.~   "
24659|NCT02734394|"~     The purpose of this project is to help to manage the many cancer treatment side effects~     through cardiovascular and resistance exercise, and education with the goal of using program~     outcomes to contribute to current research.~   "
24660|NCT02734381|"~     The number of elderly patients admitted to the Emergency Department (ED) is dramatically~     increasing.~   "
24627|NCT02734810|"~     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and~     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be~     formulated without enteric coating for administration either as a capsule or as a dosing~     solution dissolved in water or juice. The purpose of the present study is to provide~     efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder~     for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).~   "
24628|NCT02734797|"~     Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due~     to comorbidities and complications that are likely to develop before, during and after~     transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which~     affect appetite and cause gastrointestinal toxicities that limit food intake. During~     transplant, painful mucositis makes it difficult to consume adequate nutrients and often~     children will require nutrition support such as parenteral or enteral nutrition. Energy~     imbalance and physical deconditioning following transplant can result in loss of lean body~     mass and functional impairment; these nutritional side effects are exacerbated if the child~     develops graft-versus-host disease. After transplant, a substantial number of childhood~     cancer survivors become overweight and develop metabolic syndrome. However, little is known~     about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as~     obesity), the psychosocial factors that affect dietary intake and how the quality of the~     child's food intake and physical activity level throughout the transplant process might~     affect body composition and clinical outcomes. In this exploratory study, we will monitor~     nutritional status in pediatric patients undergoing HCT. This study will test the~     feasibility of collecting patient-reported dietary intake data along with anthropometric,~     body composition, functional status and psychosocial measurements that may influence dietary~     intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis~     will inform future interventional studies.~   "
24629|NCT02734784|"~     Chronic periodontitis (CP) is an infectious disease resulting in inflammation of the~     supporting structures of the teeth, progressive loss of bone loss and insertion. The aim of~     this study is to evaluate the effects of antimicrobial Photodynamic Therapy (aPDT) as~     adjuvant to periodontal surgery treatment (PST) in patients diagnosed with generalized~     severe chronic periodontitis (GSCP). Twenty patients with a clinical diagnosis of CP will be~     treated in a split-mouth design study to either aPDT associated with surgical access for~     scaling and root planning (SASRP) or SASRP only. aPDT will be performed by using a laser~     light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The~     applications will occur in only one episodes. All patients will be monitored for 30 and 90~     days after PST. Clinical assessment of plaque index, probing depth, clinical attachment~     level and bleeding on probing will be performed at baseline (pre-intervention period) and 30~     and 90 days after the PST. Subgingival plaque samples will be collected (at baseline and 30~     and 90 days after the PST) and the counts of 40 subgingival species will be determined using~     DNA-DNA checkerboard hybridization. Data obtained will be statistically analyzed.~   "
24630|NCT02734771|"~     This is a study incorporating brentuximab vedotin and dose attenuated rituximab,~     cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly~     patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the~     overlapping toxicities with brentuximab vedotin.~   "
24631|NCT02734758|"~     This study will evaluate whether a gene marker can improve the identification of atrial~     fibrillation in patients with ischemic stroke, and evaluate whether the decision to~     anticoagulate could be improved by a marker of atrial fibrillation.~   "
24632|NCT02734745|"~     This is an open-label, mono-centre, interventional study.The aim of this trial is to assess~     accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott,~     CA, USA), in patients with type 1 diabetes.~   "
24633|NCT02734732|"~     This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole~     are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a~     suspected prostate cancer.~   "
24634|NCT02734719|"~     Bonestim system for osteoporosis treatment uses surface electrical stimulation of~     neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing~     contractions of the spinal column muscles. The primary aim of this clinical study is to~     determine if the Bonestim therapy can improve bone density. A secondary aim is to determine~     whether the applied treatment increases postural stability and facilitation of daily life~     activities.~      Inducing of contractions of the spinal column muscles in this manner could be new treatment~     options for the patients with reduced mobility and the patients with serious~     contraindications for drugs.~   "
24635|NCT02734706|"~     To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242),~     taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on~     serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic~     adults after 9 weeks of product consumption.~   "
24636|NCT02734693|"~     A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12~     years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom~     setting.~   "
24637|NCT02734680|"~     The purpose of this study is to find the best model of combination of intraoperative~     radiotherapy(IORT) and postoperative radiochemotherapy for pancreatic cancer.~   "
24638|NCT02734667|"~     The purpose of this study is to learn about the impact of continuous glucose monitoring~     (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The~     investigators hope to learn about how continuous glucose monitoring affects glycemic~     variables and diabetes-related distress.~   "
24688|NCT02734017|"~     The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will~     be randomized in two groups:~        1. group receiving a pharmacist-led standardized medication review (experimental group);~          and~        2. group not receiving the medication review (control group).~      The patients will be followed up at 30 days after initial hospitalization. Outcome measures~     include the number of readmissions; patient satisfaction, quality of medical admission~     prescription and number of consultation after initial hospitalization.~      Discussion: A randomized controlled trial will provide the highest level of evidence on the~     impact of pharmacist-led standardized medication review on early hospital readmission for~     extreme age population.~   "
24639|NCT02734654|"~     Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after~     resection is associated to severe oxidative lung injury. The researchers hypothesized that~     remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the~     oxygenation parameters.~      Methods: We designed a single-centre, randomized, prospective and double-blind study,~     conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung~     lobectomy.~      Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3~     cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh)~     and 27 controls.~      Time course of oxidative stress marker levels was simultaneously studied in exhaled breath~     condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during~     operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming~     two-lung ventilation (TLV); T3, 120 min after resuming TLV.~      EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other~     pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.~   "
24640|NCT02734641|"~     The purpose of this study is to examine whether iron therapy in patients with intravenous~     iron deficiency anemia causes an increase in appetite. And whether this increase is mediated~     by the hormone ghrelin.~   "
24641|NCT02734628|"~     The objective of the study was to investigate the efficacy of Bepanthen® wound healing~     ointment compared to placebo in a superficial abrasive wound model. The primary objective~     was the re-epithelization at Day 5.~      The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15,~     assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36~     (investigator and subject), and documentation and analysis of safety parameters.~   "
24642|NCT02734615|"~     To characterize the safety and tolerability, identify recommended doses and regimens for~     future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of~     LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients~     with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine~     therapy.~   "
24643|NCT02734602|"~     This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic~     density, and to determine whether ketamine administration will reverse the synaptic loss in~     vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in~     vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses~     synaptic loss to determine whether ketamine administration could restore some of the~     structural changes associated with depression and PTSD.~      After a screening process to determine eligibility, all subjects will participate in an MRI,~     and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive~     testing and a stress test may also be done on scan days.~   "
24644|NCT02734589|"~     Changing the microbiota has become the most intriguing target for intervention in~     inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's~     disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though~     dietary interventions in UC are just getting underway. However these interventions are less~     likely to be effective for the more severely inflamed or refractory end of the spectrum.~     Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most~     studies have been unsuccessful in establishing remission and especially prolonged remission.~     The investigators hypothesize that this is due to selection of random donors and the~     inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful~     tool to modulate the microbiota. The investigators propose to modify FT using a novel~     protocol and approach that we have developed. We have developed a unique diet that is geared~     to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators~     intend to condition both donor and recipient with the diet to achieve optimal conditions for~     transplant to succeed for both donor and recipient .The investigators intend to evaluate~     this protocol in adults with active UC that are refractory to medications. The investigators~     will start with a randomized controlled trial involving 76 transplanted patients, however in~     the first pilot stage The investigators will enroll 34 patients, and extend the study if~     there is a trend for better outcomes with the dietary conditioning protocol. Furthermore,~     The investigators hope to identify successful donors during this period to use during the~     study extension.~   "
24645|NCT02734576|"~     There have been few published studies that examine the efficacy and safety of endovascular~     treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited~     experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show~     that venous sinus stenting could represent a viable alternative for refractory pulsatile~     tinnitus patients with venous sinus stenosis. The purpose of our study is to evaluate the~     safety and efficacy of this procedure in a controlled fashion, using strict inclusion and~     exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to~     provide robust data regarding the safety and efficacy of venous sinus stenting for patients~     with pulsatile tinnitus.~   "
24646|NCT02734563|"~     The aim of this study was to evaluate collagen turnover in patients with multiple hernias~   "
24647|NCT02734550|"~     This prospective randomized multicenter study evaluates whether the decision to prescribe~     antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to~     antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and~     a high risk of invasive candida infection.~   "
24648|NCT02734537|"~     This phase II trial studies how well radiation therapy with or without cisplatin works in~     treating patients with stage III-IV squamous cell carcinoma of the head and neck who have~     undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known if radiation therapy is more effective~     with or without cisplatin in treating patients with squamous cell carcinoma of the head and~     neck.~   "
24649|NCT02734524|"~     The main purpose of this study is to explore if the combination of autologous NK cell~     infusion and chemotherapy can increase the therapeutic efficiency in the treatment of~     non-small cell lung cancer compared with chemotherapy alone.~   "
25437|NCT02724215|"~     In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for~     sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and~     worse clinical outcome early after SAH.~   "
24650|NCT02734511|"~     Relieving symptoms of patients hospitalized in a palliative care unit is a priority.~     Although they receive appropriate care, they may still experience pain refractory to~     analgesia or/and to conservative treatment during care procedures. For instance, pain can be~     caused by the bandaging of carcinological or ischemic wounds, or by the mobilization of~     traumatic injuries which cannot be specifically treated.~      Although these types of situations are rare, they remain unacceptable, especially at the end~     of life.~      According to current recommendations, a short-term sedation treatment can be administered~     although detailed procedures for this type of sedation have not been very much documented.~     In reality, midalozam is often used in those cases but it has drawbacks, which is why the~     investigators have looked into alternatives.~      Propofol, which is already widely used in anesthesia and emergency medicine to manage~     painful procedures, seems to be an interesting molecule because of its pharmacological~     properties. It allows to quickly reach deep sedation and thus obtain a certain level of~     comfort for the patient, but also ensures a prompt awakening as soon as care procedures are~     over, which limits respiratory side effects.~      The results from a preliminary study encouraged us to go further and to present a~     prospective study conducted in multiple centers in order to evaluate the efficiency and~     safety of a procedural sedation administered by trained doctors who are not~     anesthesiologists on terminally ill patients with refractory pain hospitalized in a~     palliative care unit.~   "
24651|NCT02734498|"~     The purpose of this treatment study is to compare the effectiveness of different electrode~     placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this~     study Electroconvulsive Therapy will be compared to medications used in the treatment of~     catatonia. Medications will be administered by the primary team as part of standard of care.~     Medications are not primarily being used as a part of this research study.~      This treatments study, will be able to compare response rate of catatonia to right~     unilateral electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment~     (BL ECT). Also having a control group of catatonia patients, which will not be treated with~     ECT will provide additional information on early ECT treatment of Catatonia.~   "
24652|NCT02734485|"~     Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease,~     counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely~     limited in AP, therefore it would be very useful to find new ways to improve motor and non~     motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new~     technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of~     the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's~     Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement~     in language.~   "
24653|NCT02734472|"~     Essential hypertension is a complex trait which results from interaction between~     environmental factors and genetic factors. The aim of this study is to investigate the~     effects of interaction between environmental factors and genetic factors on long-term blood~     pressure (BP) based on two established cohorts including the cohort of Hanzhong adolescent~     hypertension study and the cohort of Mei county adult salt-sensitive hypertension study.~     Firstly, the Hanzhong cohort-based follow-up study is designed to observe the track of BP~     during the whole life time, and to explore the effects of many risk factors (such as~     salt-sensitivity, obesity et al) on long-term BP and the occurrence of hypertension, and~     also to analyze the relationship of different polymorphisms of sodium and potassium~     metabolism-related gene with BP changes and target organ damages. In addition, by using DNA~     samples collected from subjects of Mei county adult salt-sensitive hypertension studyin~     which all participants had completed a chronic salt loading and potassium intervention~     trial, we attempt to examine the single nucleotide polymorphisms (SNPs) of sodium and~     potassium metabolism-related genes, as well as the relationship between these SNPs and BP~     responses to dietary sodium/potassium intervention, long-term BP change, the risk of~     hypertension and target organ damages were analyzed. This study would enable us to further~     explore the etiology of essential hypertension as well as to identify new genetic markers~     for predicting early hypertension and target organ damage.~   "
24654|NCT02734459|"~     Each patient will be randomized to receive one dose of the test article in one eye and one~     dose of the reference formulations in the contralateral eye. One eye will be selected as the~     initial eye for cataract surgery and aqueous humor collection and hence will be dosed and~     operated on first. Followed by the second eye which will be dosed no early than a week~     followed by aqueous humor collection as per specified time points and no later than 35 days~     following the first eye again prior to the cataract surgery.~   "
24655|NCT02734446|"~     The purpose of this project is to evaluate in a randomized clinical trial, double-blind,~     controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938~     and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in~     children with mild / moderate persistent asthma .~   "
24656|NCT02734433|"~     This is a Phase 1, non-randomized, open-label, multiple dose study of pexidartinib in Asian~     subjects with advanced solid tumors. The study will be conducted in a dose escalation to~     assess the safety and tolerability, PK and PD, and preliminary antitumor activity of~     pexidartinib.~   "
24657|NCT02734420|"~     The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT)~     on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting~     deep carious lesions on the occlusal surface indicated for restorative treatment will be~     randomly allocated to three groups: Group 1 - traditional caries removal with a low-speed~     drill; Group 2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene~     blue; and Group 3 - PDT with methylene blue 0.05%. PDT will be performed with low-level~     laser for the treatment of the carious tissue. Dentin samples will be removed before and~     after PDT for microbiological analysis. The microbiological samples will be cultured in~     Brucella blood agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will~     then be restored using high-viscosity glass ionomer cement, with clinical and radiographic~     follow up at six, 12 and 24 months. The data will be submitted to descriptive statistics.~   "
24658|NCT02734407|"~     The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet~     re-treatment criteria will be eligible for focal laser treatment every 90 days~   "
24661|NCT02734368|"~     The purpose of this study is to determine the MRI characteristics of Chronic Obstructive~     Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to~     correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and~     respiratory questionnaires.~      The central hypothesis is that quantitative assessment of the lung through magnetic~     resonance imaging of hyperpolarized 3He can detect early alterations in structure and~     function which are precursors to clinically apparent COPD and that these precursors can be~     used to predict progression of disease earlier and better than established clinical methods.~      Novel assessments using 3He MRI will lead to new information about COPD and will be critical~     for characterizing disease response to therapy. A secondary hypothesis is that a variety of~     technical improvements in the techniques of hyperpolarized gas MRI will accelerate the~     translation of this relatively new modality to clinical use.~   "
24662|NCT02734355|"~     The objective of the study was to estimate the efficacy of telmisartan and amlodipine~     combination on the restoration of left atrial mechanical function after atrial fibrillation~     catheter ablation.~   "
24663|NCT02734342|"~     Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint~     stiffness and generalized muscle weakness. 90% of OA presentation has been reported within~     the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the~     next twenty years due to an ageing population, obesity, and societal trends such as lack of~     activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore~     an understanding of how psychological and functional relationships effect exercise~     engagement, which in turn would provide a more comprehensive rehabilitation programme for~     patients with knee OA. The aim of this study is to investigate exercise in knee OA and it~     it's correlation with fear of movement, using a mixed methods approach. Quantitative~     methodology will investigate lower limb exercises for pain and function and fear of~     movement. The desired outcome of the study will show that a reduction in pain with patient~     specific exercise will also reduce the fear of movement and allow patients to self-manage~     their symptoms without fear. Other quantitative factors such as intensity of exercise and~     postural stabilization using the Y balance test will also be utilized to review the~     functional relationship of muscle strength and balance to kinesiophobia. A semi-structured~     interview will be completed at the end of the course of treatment to highlight what patients~     think about exercise as an intervention. Participants aged forty-five and above with~     specific clinical symptoms will be invited into the study and will be asked to attend eight~     exercise sessions within a class environment, which will last for 1 hour within the~     Physiotherapy Department.~   "
24664|NCT02734329|"~     Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been~     proved to enable tumor excision with relatively better renal function preservation comparing~     with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a~     randomized clinical trial in single center. The investigators want to explore this technique~     to T1 RCC patients in randomized clinical trial in multiple centers.~   "
24665|NCT02734316|"~     The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in~     patients undergoing endoscopic procedures is still not completely clear. Current European~     guidelines are based on weak data. This observational study aims to evaluate the~     peri-endoscopic management of DOACs in clinical practice and the incidence of adverse~     events.~   "
24666|NCT02734303|"~     Background:~      The first nuclear bomb test took place in New Mexico in July 1945. This was called the~     Trinity test. Researchers want to learn how it affected the health of people who lived in~     New Mexico at the time of the test. To do this, they want to learn about the diet and daily~     life of those people at that time. They want to study Native Americans, Hispanic/Latinos,~     and non-Hispanic/Latino whites.~      Objective:~      To learn about the health risks for people who may have been exposed to radiation from the~     Trinity nuclear test.~      Eligibility:~      People who:~        -  Are Native American, Hispanic/Latino, or non-Hispanic white~        -  Are age 70 and older~        -  Lived near the fallout region of the Trinity test and know about lifestyle and dietary~          patterns in New Mexico in the 1940s and 1950s~      Design:~      Participants will be screened with a questionnaire.~      Participants will answer questions in an interview or a focus group. This will be at a place~     like an office, tribal or community center, or library. It will take up to 2 hours. The~     interview or group session will include:~        -  Questions about their and their family members activities and eating habits in the~          1940s and 1950s~        -  A card-sorting exercise: There will be cards with pictures and names of certain foods.~          They will sort the cards into 2 piles: those that were consumed and those that were~          not.~        -  Filling out a chart of their family members and the foods they ate~      If participants give permission, their interview or group session will be recorded.~   "
24667|NCT02734290|"~     The goal of this study is to establish the safety and tolerability of pembrolizumab when~     administered in combination with either of two chemotherapy regimens (weekly paclitaxel or~     capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.~   "
24668|NCT02734277|"~     To further our understanding of the immunologic mechanisms underlying maintenance and loss~     of beta cell function by evaluating the relationship between longitudinal changes in beta~     cell function and changes over time in biomarkers known to be associated with a response to~     immune modulating treatments which were used in prior clinical trials (Refer to~     ClinicalTrials.gov records NCT00129259 and NCT00965458).~   "
24669|NCT02734264|"~     The purpose of this study will be to investigate the incidence of both Amebiasis and~     cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and~     adaptive immunity with respect to these infections. Novel diagnostics to these infections~     will also be investigated.~   "
24689|NCT02734004|"~     The purpose of this study is to look at the effectiveness, safety, and antitumor activity of~     study drugs MEDI4736 in combination with olaparib. It will also examine what happens to the~     study drugs in the body and investigate how well the combination between MEDI4736 and~     olaparib is tolerated.~   "
24824|NCT02732249|"~     Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with~     either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy~     to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown~     whether the addition of bismuth overcome antibiotic resistance. This study is designed to~     evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for~     H. pylori first-line eradication.~   "
24670|NCT02734251|"~     The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate~     the effects of Relora supplementation on responses to induced stress produced by a~     combination of cognitive and physiologic stressors in healthy men and women. The effects of~     the supplement, compared with a placebo, will be evaluated using measures to assess anxiety~     [State-Trait Anxiety Inventory-Part 1 (STAI-Part 1), mood [Bond-Lader Visual Analog Scale~     (VAS)], hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive~     function (cognitive flexibility, reaction time, processing speed, attention, sustained~     attention, working memory, and executive function). Testing will be completed at the~     beginning and end of 7-d supplementation periods with the active and placebo products to~     assess both the acute effects and the acute-on-chronic effects following one week of daily~     use.~   "
24671|NCT02734238|"~     The objective of this study is to determine whether maintaining a eugonadal state, during~     severe, sustained energy deficit, attenuates physiological decrements, particularly the loss~     of lean body mass, and maintains mental performance.~   "
24672|NCT02734225|"~     Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's~     proprioceptive system increasing instability. After total knee arthroplasty intervention, it~     is recommended that the patient performs a rehabilitation procedure to minimize deficits~     caused by surgery. In this job it is essential to insist on the importance of recovering~     balance after total knee arthroplasty intervention, and assess a specifically designed~     protocol to restore its function. An intervention which includes a dynamometric platform as~     a training method was proposed. The randomized clinical trial compared a control group that~     performed balance exercises on parallel bars, unstable plates, ramps and stairs against an~     experimental group that included dynamometric platforms training as a differentiator.~   "
24673|NCT02734212|"~     Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their~     participation in mental health treatment. Despite the widely-documented effects of stigma on~     the recovery of individuals with mental illnesses and research demonstrating harmful~     consequences of internalized stigma, including decreased hope, self-esteem, personal~     motivation, and persistence regarding illness management, no interventions are currently~     available to assist Veterans with PTSD in combating the impact of internalized stigma. The~     goal of this research is to develop and pilot-test an intervention to provide Veterans with~     PTSD the skills to cope effectively with stigma and to mitigate the internalization of~     stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS),~     an intervention composed of evidence-based methods for combating internalized stigma for~     serious mental illness, will be modified and tested to address issues particular to PTSD.~   "
24674|NCT02734199|"~     This study aims to understand the long-term health, social, and economic impacts of~     transitioning a community to Highly Effective Reversible Contraception (HER-C).~   "
24675|NCT02734186|"~     Background:~      Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma~     haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver~     problems or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. After~     taking it, some people develop increased resistance to reinfection with Sh. Some people with~     Sh infection can be infected with another worm called Mansonella perstans (Mp). Mp is spread~     through a biting insect called a midge. It rarely causes symptoms. However, researchers~     think that Mp infection could affect the body s response to PZQ treatment for or risk of~     reinfection with Sh.~      Objective:~      To find out the effects of Mp infection on the response to PZQ treatment for Sh infection.~      Eligibility:~      Men and women ages 14-80 who:~        -  Live in Tieneguebougou, Bougoudiana, or surrounding villages in Mali~        -  Are not pregnant~        -  Have Sh infection~        -  Have no other chronic medical conditions~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  Stool samples~        -  Participants will be treated with a single dose of PZQ by mouth.~        -  After receiving PZQ, participants will return to the clinic for blood and urine tests~          at the following times:~             -  4, 8, 24, 48, and 72 hours later~             -  5, 7, 9, and 14 days later~             -  1, 3, and 6 months later~      Participants who are infected with Sh at the 6-month visit will get another treatment with~     PZQ.~   "
24676|NCT02734173|"~     There is compelling data supporting the pursuit of research into the effects of HCV~     antivirals on metabolic homeostasis. As a further rationale and justification, the~     experience with HIV antiretrovirals has clearly demonstrated that antiviral medications can~     produce profound changes in glucose metabolism, lipid profile and other measures of~     metabolic homeostasis. This establishes biological plausibility for this focus of research~     in HCV.~      The new knowledge created from this research will:~        1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral~          regimen.~        2. Provide insight as to whether there are metabolic advantages with RBV-free compared to~          RBV-containing HCV regimens. This is particularly relevant given the current~          uncertainty regarding the need for RBV in IFN-free, oral DAA regimens.~        3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and~          after HCV antiviral therapy~   "
24677|NCT02734160|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     known as galunisertib administered in combination with the anti-programmed cell death-ligand~     1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.~   "
24690|NCT02733991|"~     A premarket, international multicenter, prospective, open label, adaptive, randomized~     controlled study.~      The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and~     SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous~     insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia.~     The primary objective is to demonstrate a reduction in the mean number of hypoglycemic~     events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will~     aim at evaluating the difference in glycemic parameters and HbA1c.~   "
24691|NCT02733978|"~     Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and~     microtrauma with high impact on quality of life, management of DUs is a great challenge for~     clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone~     has multiple therapeutic effects in wound healing due to the property of releasing nascent~     oxygen, which has been shown to stimulate antioxidant enzymes.~   "
24678|NCT02734147|"~     Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis~     with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult,~     and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence~     continues to rise, making sepsis the most expensive inpatient disease.~        1. Recent research has described the therapeutic benefits associated with ascorbic acid~          treatment for sepsis.~        2. Researchers objectives are to perform a randomized-controlled clinical trial~          investigating the ability of ascorbic acid(vitamin C) administration to decrease organ~          dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in~          sepsis leading to tissue hypoxia, mitochondrial dysfunction, and ATP depletion, gives~          rise to organ failure.~        3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death~          than patients with organ failure alone. Critically ill patients may have an increased~          requirement for ascorbic acid in sepsis and these patients frequently have levels below~          normal. Ascorbic acid administration, has been shown to correlate inversely with organ~          failure (human literature) and directly with survival (animal studies).~      4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective~     effect on several microvascular functions including improving capillary blood flow,~     decreasing microvascular permeability, and improving arteriolar responsiveness to~     vasoconstrictors. Defining the utility of novel agents to augment researchers care for~     severe sepsis is an important task as investigators continue the institutional focus on~     sepsis care.~   "
24679|NCT02734134|"~     The purpose of this study is to compare the outcomes of two different treatment options~     commonly used to manage periprosthetic joint infection (PJI), an infection around the~     artificial knee or hip.~   "
24680|NCT02734121|"~     The purpose of this study is to determine the effectiveness of a pre-consultation decision~     support workshop for breast reconstruction after breast cancer, in facilitating the~     decision-making process, compared to routine pre-surgical education.~   "
24681|NCT02734108|"~     Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite~     the obvious thinness and extreme behaviors for weight loss. The result is a massive weight~     loss and / or pathological thinness. The care of anorexia is difficult and few treatments~     have proved to be effective in adults.~      Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an~     electrical current of low intensity. It allows to modulate the corticospinal excitability:~     two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the~     skull according to the region which is desired to influence the operation.~      Although tDCS was shown to no noticeable side effects, it is first necessary to assess the~     feasibility and safety of this technique in these physically frail patients. A recent pilot~     study suggests the acceptability, safety and efficacy of tDCS program in patients with~     anorexia nervosa.~      Given these preliminary data and the extreme seriousness and vulnerability of patients with~     resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of~     this technique in patients suffering from resistant anorexia nervosa. The current data are~     too preliminary to consider a randomized controlled trial, the investigators hope,~     initially, replicate the data from this pilot study in a second sample with a more rigorous~     and comprehensive assessment methodology .~   "
24682|NCT02734095|"~     A prospective, single-center, real-world study on intravascular ultrasound measurements~     after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal~     lesions.~   "
24683|NCT02734082|"~     Many studies have shown that acute cerebral dysfunction can impair cardiac function and~     autonomic control of blood pressure, heart rate and vascular tone, however, the size of the~     stroke is rarely reported. Involvement of the insular cortex seems to predispose to cardiac~     damage and autonomic dysfunction. However, it is not clear whether cardiac dysfunction is~     merely a marker of large strokes or location of the stroke is critical.~   "
24684|NCT02734069|"~     This study evaluate the association of body composition (mainly free-fat mass), clinical and~     biochemical parameters with development of toxicity in patients under treatment with~     Carboplatin/Paclitaxel in advanced NSCLC.~   "
24685|NCT02734056|"~     Patient satisfaction is becoming increasingly important to hospital administrators as a~     metric for quality of patient care services because it is now being linked to reimbursements~     (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of~     factors. A recent study found that higher patient satisfaction was associated with patients~     who received music therapy during their hospital stay (Mandel 2014). Given that music may~     positively affect patient satisfaction, we are designing a study to examine the effects of~     patient-preferred music on patient satisfaction in women undergoing labor epidural~     placement.~   "
24686|NCT02734043|"~     The objective of the study is to provide a road map that can help organizational leaders~     understand how to sequence their financial and human capital investments related to bundled~     payment arrangements. Although specific strategies will vary between organizations,~     providing evidence from a health system with extension experience bundling care for~     orthopedic joint replacements can be instructive for other providers entering new building~     arrangements. Insights from the experience of the health system can help other organizations~     prioritize effort and focus energy around strategies that increase the likelihood of~     succeeding under Comprehensive Care for Joint Replacement (CJR) and other bundled payment~     contracts.~   "
24687|NCT02734030|"~     This study aims to compare the knee extensors' mechanical, morphological and myoelectric~     properties between subjects affected by anterior knee pain and a healthy control group. The~     investigators hypothesis is that patients with anterior knee pain present a reduction in the~     knee extensors' mechanical, morphological and myoelectric properties due to chronic muscle~     inhibition produced by the syndrome. In addition, the study also aims to evaluate whether~     there are differences in methodology for application of the Interpolated Twitch Technique~     for evaluation of the quadriceps muscle inhibition by comparing the use of supramaximal~     electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor~     point (new methodology) in healthy subjects and individuals affected by anterior knee pain.~     The investigators hypothesis is that the stimulation on the motor point is less~     discomfortable than on the femoral nerve and muscle inhibition results are less variable~     (with lower dispersion) due to such lower discomfort~   "
24692|NCT02733965|"~     The improvement of the care pathway of oncology patients through Clinical Pharmacy~     activities for outpatients (such as pharmaceutical consultation) should be implemented and~     evaluated.~      In order to improve the care pathway of patients on anticancer oral therapies, The~     investigators suggest in this research project to integrate into the medical care a~     Clinical Pharmacy follow-up for the patient at the hospital in the form of pharmaceutical~     consultations. These pharmaceutical consultations carried out in coordination with the~     hospital clinical teams also aim to make the link between the hospital and community~     pharmacists.~   "
24693|NCT02733952|"~     Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In~     Trans-Abdominal Myomectomy~   "
24694|NCT02733939|"~     This randomized controlled trial aims to recruit a total of 320 dyads composed by persons~     with dementia living in community settings and their primary informal caregivers. In the~     intervention group, persons with dementia will have a home monitoring kit installed in the~     household while participants in the control group will receive their usual care. The kit~     includes home leaving sensors, smoke and water leak sensors, bed sensors as well as~     automatic lights that monitor the individual's behavior. Alerts (text message and/or phone~     call) will be sent to the caregiver if anything unusual occurs. All study participants will~     receive three home visits by project administrators that have received project specific~     training in order to harmonize data collection. These will take place at enrollment and 3~     and 12 months following installation of the home kits. At every home visit, a standardized~     questionnaire will be administered to all study participants to assess their health, quality~     of life and resource utilization. The primary outcome of this trial is the amount of~     informal care support provided by primary informal caregivers to the Person with Dementia.~   "
24695|NCT02733926|"~     This study evaluates the effect of vegetation cover on certain Interleukin-10 and~     immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten~     that does not have forest floor and agricultural land in the backyards, or alternatively~     they will be in a kindergarten that does have forest floor and agricultural land in the~     backyards.~   "
24696|NCT02733913|"~     Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF),~     however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA)~     reconnection, the cause of recurrence has been not yet fully clarified.~      The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It~     was reported that there are multiple gangliated plexus (GP) around pulmonary veins,~     therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic~     tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients.~      According to the previous reports, heart rate (HR) increased, and heart rate variability~     (HRV) reduced after PVI. These are considered to be due to autonomic denervation caused by~     catheter ablation of GP.~      For the best of investigators knowledge, there have been no data on heart rate turbulence~     (HRT) of baroreflex sensitivity (BRS) concerning PVI.~   "
24697|NCT02733900|"~     In this study, the aim is to identify the modifications responsible for aseptic~     osteonecrosis of the femoral head and its structural evolution by the association of the~     micro scanner analysis and Raman spectrometry performed on the femoral heads removed during~     hip replacements. The study of femoral heads will allow the analysis of bone tissue at two~     different scales, both correlated with the biomechanical properties of the bone. Also, the~     association with preliminary MRI analysis will provide pathogenic explanations correlated to~     these modifications.~   "
24698|NCT02733887|"~     The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT)~     standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI)~     intravoxel incoherent motion(IVIM) sequence D, D*, f values and MRI volumes of lymphoma~     patients were compared before and after the chemotherapy in this project prospectively to~     provide data for evaluating the dependency and differences of PET/CT and whole body MRI in~     lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained~     in follow-up visits of patients such as Overall Survival(OS), Progression Free Survival~     (PFS) etc. were used to evaluate the diagnostic sensitivity and differences of MRI and~     PET/CT. The research could provide a new method of nonionizing radiation iconography for~     physicians to give appropriate treatments and predict prognosis.~   "
24699|NCT02733874|"~     A multi-center, randomized, single blind, positive controlled trials that assess the~     effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate~     psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol~     Betamethasone Ointment.~      Objectives of Study：~        1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment~          in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;~        2. Compare the cost-effectiveness analysis of two treatment programs.~   "
24700|NCT02733861|"~     With the development of oral medicine,dental implants has become a very popular solution to~     remediate the loss of teeth and dental rehabilitation. For the last few decades, the~     immediate loading protocol have become more and more popular because the increasing demands~     of shortened treatment time. Implant stability is considered one of the most important~     parameters in implant dentistry. It affects the healing and successful osseointegration of~     implants. For any implant procedure, successful implant integration is a prerequisite~     criterion, which depends on a series of procedure-related and patient-dependent factors. It~     also has been considered that preoperative measurement is critical and may give valuable~     information to predict loading time and survival of the implants.~      In this clinical study, the samples were collected from patients with single teeth missing~     who came from the department of prosthodontics from the School of Stomatology of the Fourth~     Military Medical University.The prospective cohort study was used to investigate the~     correlation between different factors and the early stability of the implants. And then,~     using the correlation between different factors and the early implant stability gives~     predictable data about implant stability and then evaluate the accuracy and reliability.~   "
24735|NCT02733406|"~     Hypotension will often complicate induction of anaesthesia. The investigators want to test~     the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion,~     leads to less degree of hypotension.~   "
24825|NCT02732236|"~     Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity,~     prospective clinical trial is difficult to conduct. Therefore we want to make prospective~     MZL patients' cohort for several observation study~   "
24701|NCT02733848|"~     Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB)~     that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB~     some patients have incomplete carbohydrate absorption in the small intestine which leads to~     inconsistent glucose levels and hypoglycemia during oral consumption of a meal.~     Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during~     meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels~     in patients with post-RYGB hypoglycemia.~   "
24702|NCT02733835|"~     This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil~     algorithm which would benefit labouring mothers who are unable or unwilling to receive~     epidural analgesia~   "
24703|NCT02733822|"~     Naloxone is the standard treatment in response to cases of suspected opiate overdose.~      Buccal formulation of naloxone is a novel alternative to the licensed naloxone injection~     which, by removing the risk of accidental needle-stick, may be safer and easier to~     administer.~      Current UK policy allows the emergency administration of naloxone by any member of the~     general public (Strang, Kelleher, Best, Mayet, & Manning, 2006), and the preventative~     provision of naloxone to drug users and their family members (take-home naloxone) is~     possible on a prescription basis. Thus, buccal naloxone may be particularly suitable for~     administration by family members who are providing interim overdose management care while~     awaiting the arrival of an ambulance.~      The aim of this study is to examine the bioavailability and dose proportionality of buccal~     naloxone compared with the licensed injection standards (intravenous, intramuscular).~      The investigators hypothesise that buccal naloxone is not inferior to the injection~     reference in absorption kinetics, i.e. time elapsed till peak concentration (Tmax; primary~     outcome), peak plasma concentration (Cmax), overall absorption (AUC), bioavailability (F%)~     and, duration of action (mean terminal half-life; T1/2).~      The investigators propose a pharmacokinetic pilot investigation with within-subjects~     (crossover) design, comparing two doses (0.8 mg; 1.6 mg) of buccal naloxone hydrochloride~     solution to the licensed intramuscular (IM; 0.8 mg) and intravenous (IV; 0.8 mg) routes of~     injection. The investigators will invite four healthy (i.e., non-opioid using) male~     volunteers (n=4, not powered), each of whom will attend four experimental sessions at~     counterbalanced sequence. Each volunteer will receive naloxone hydrochloride doses of 0.8 mg~     IM, 0.8 mg IV, 0.8 mg buccal, and 1.6 mg buccal, with only one dose administered per~     session.~      Blood concentrations will be measured at selected times during each session to establish~     speed of naloxone absorption, time to peak concentration, estimated half-life, and overall~     bioavailability. This dose-ranging pilot will inform future work by providing preliminary~     data on buccal naloxone absorption into the bloodstream and by establishing feasibility of~     the buccal route for naloxone delivery.~   "
24704|NCT02733809|"~     It has been shown previously that gene expression profiling signature (a set of dysregulated~     genes) can be used for molecular classification, diagnosis, and prognosis of several types~     of cancers. In This study the hypothesise that resistant tumor may be due to genetic~     mutations and/or other alternative pathways that could be the reason to overcome the~     Sorafenib and still proliferate.~      Primary objectives To evaluate the primary and secondary potential mechanisms by which HCC~     patients on Sorafenib treatment would be resistant to therapy and also identify the~     favorable genetic makeup of patients responding to treatment.~      Measures of primary outcome:~        -  cDNA microarray analysis on the MAP kinase pathway.~        -  mRNA quantification of genetic expression (RT-PCR) for identification of upregulated~          genes, and confirmed by corresponding proteomic testing (by Mass Spectroscopy) in the~          serum for potential serum markers. Secondary Objectives Progression free survival: Time~          to disease progression in patients in Saudi Arabia with HCC receiving Sorafenib:~          [defined as time, in weeks, from the baseline visit to progression of the disease or~          death from any cause] will be diagnosed using the RECIST criteria based on a~          trimestrial abdominal CT evaluation.~        -  Survival rates and Predictors of survival:~             -  Survival defined as the time from baseline visit to death from any cause [in~               weeks].~             -  Variables identified in multivariate regression analysis from overall treated~               patients independently associated with survival till study completion or death.~               Justification and Value to the Kingdom Sorafenib in the treatment of advanced HCC~               is a recent development. Since the only current effective treatment for advanced~               HCC is resection or transplantation and the list for these procedures are~               ever-growing due to the confounding effect of the lack of infrastructure in the~               Kingdom, selecting treatment for patients who are more likely to respond to~               Sorafenib treatment The Long-Term Comprehensive National Plan for Science,~               Technology and Innovation will help to reduce costs of managing HCC. Among Saudi~               Arabia population, there are a unique set of patients here (e.g. non-alcohol~               related HCC, genotype 4 HCV patients and genotype D HBV patients, high percentage~               of obese patients i.e. NASH) which is different from other parts of the world.~               There is increasing incidence of HCC in Saudi Arabia. Due to available expertise~               in management of HCC patients in the participating institutions in the study, this~               project will represent a bridge for the transfer of technology so that our~               research staff and doctors will have more expertise in carrying out these~               techniques independently. This study will also run in parallel to the on-going~               initiative to start a HCC biobanking establishment which will provide the samples~               needed to carry out our genetic studies in future. Finally, since the use of~               Sorafenib (at present, the only approved treatment for advanced HCC) in the~               treatment of advanced HCC is a new field, the findings of our study will have~               important implications in the management of HCC, both locally and internationally.~      HCC is the third most common cancer in Saudi Arabia. In 2001, HCC was the second most common~     cancer affecting Saudi males and the eighth most common cancer affecting females. Most of~     patients (90%) present at a more advanced stage when symptoms prevail.~      Given the high prevalence of HCC in the Kingdom, it is pertinent to study why some patients~     are resistant to Sorafenib compared to others. Elucidation of the differences in mechanisms~     among responders and non-responders to Sorafenib therapy will enable physicians to make~     better decisions in terms of treating Saudi HCC patients.~   "
24705|NCT02733796|"~     This is a prospective observational laboratory evaluation of the persistence rate of zika~     virus (ZIKV) infection in semen by real-time Reverse Transcriptase Polymerase Chain Reaction~     (RT-PCR), and assessment of ZIKV replication-competence in semen by isolation of ZIKV.~     Evaluation of the persistence of ZIKV and its replication-competence in semen samples will~     increase the understanding of the risk of sexual transmission of ZIKV infection in the~     post-viremic phase in non-epidemic settings.~   "
24706|NCT02733783|"~     The primary aim of the study is to create a model; in order to examine the effects of neural~     trauma in patients that are healthy individuals, induced by controlled nasal fractures~     during rhinoplasty, and the regeneration process in the weeks/months that follow. This study~     includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score,~     peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal~     provocation (response to capsaicin and cold dry air (CDA) exposure).~   "
24707|NCT02733770|"~     Obesity if a health endemic problem over the entire world. Bariatric surgery is the best~     chance for those patients with morbid obesity to loss weight and to maintain the loosed~     weight.~      Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric~     by pass due to the recognized changes in the homeostasis of the hormonal secretion~     responsive to the hunger status. After sleeve gastrectomy we observe many patients with~     thrombus of the portal vein system. This phenomena may be attributed to changes in the~     portal flow due to devascularization of the great curvature of the stomach.~      The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound~     before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass,~     were the vascularization is not changed by the surgery.~   "
24708|NCT02733757|"~     Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure~     (IOP) or the pharmacological action of local anesthetics. This study was conduced to~     evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO)~     and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's~     and peribulbar anesthesia.~   "
24709|NCT02733744|"~     This research study is studying an intervention called fecal microbiota transplantation~     (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are~     invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic~     engraftment. The primary endpoint will be to assess the feasibility of FMT in this~     population and to assess safety.~   "
24710|NCT02733731|"~     Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on~     senile atrophic compared as compared to estriol cream in aged woman.~      Design: A randomized double-blind controlled trial.~      Setting: The hospital ward.~      Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).~      Intervention: The traditional chinese medicine oil and estriol cream were separately~     intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1~     month.~      Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall,~     vaginal discharge, and PH changes.~   "
24711|NCT02733718|"~     This study aims to compare the differences between three different feeding regimens on~     intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.~   "
24712|NCT02733705|"~     Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer.~     This procedure causes pain to the patients who does not received the sedative drugs or~     analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such~     as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists~     usually give intravenous propofol with intravenous opioids but the visual analogue score~     after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown~     that there was no difference in pain score between periprostatic nerve block plus opioid and~     periprostatic nerve block only. So, this study is to find out whether opioids is need for~     TRUS biopsy.~   "
24736|NCT02733393|"~     The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG)~     block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open~     label preliminary pilot study to determine if SPG block has potential utility to manage ISP~     in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder~     pain.~   "
24713|NCT02733692|"~     Smartphone applications and mobile technologies offer users the potential to access critical~     information (e.g., proper condom use, directions to testing sites, and other sexual and~     reproductive health services) when it is needed most. Relevant findings will identify areas~     where existing interventions may be leveraged and adapted to work among young women of color~     in an urban setting and their networks. As SRH smartphone apps continue to proliferate, this~     study will expand researchers', developers', and health educators' limited knowledge about~     the feasibility, acceptability and preliminary efficacy of a sexual health educational app~     tailored with and for young Black and Latino women, aged 18-25 in NYC, including whether~     this app acts as a gateway to sexual health educators, clinical and other service providers.~     If proven effective, findings from this study will identify areas where existing~     interventions may be leveraged and adapted to work among a YBLW and their networks, and~     potentially adapted for other high needs communities.~   "
24714|NCT02733679|"~     This study aims to investigate the link between the Ataxia Telangiectasia Mutated (ATM) gene~     and metformin response. This link has been identified from large studies of the human~     genome, and this study aims to confirm this link in a clinical study. The ATM gene is~     involved in DNA repair - if a person inherits a faulty copy of this gene from both their~     parents, they have a genetic condition called Ataxia-telangiectasia (A-T).~      A-T is associated with, among other things, a resistance to insulin, which causes fatty~     liver and diabetes. This study will recruit people who have A-T, but have not developed~     diabetes, and compare this group to healthy controls, i.e. people who do not have A-T or~     diabetes. The study will compare how the groups respond to two drugs used to treat diabetes~     (metformin and pioglitazone), with the intention that this will guide the management of~     diabetes in A-T.~      This is an, open label unblinded study recruiting 15 people with A-T and 15 age and gender~     matched controls. Each participant will have three study visits to the Clinical Research~     Centre at Ninewells hospital in Dundee - one at baseline, a second after 8 weeks of~     metformin and the final visit after eight weeks of pioglitazone. During each visit we will~     carry out a number of investigations to study the insulin resistance of A-T and how it~     responds to metformin and pioglitazone.~   "
24715|NCT02733666|"~     Lateral humeral condyle fractures are the second most common elbow fractures in children.~     Displaced and rotated fractures require stabilization and reduction. Kirschner wires~     (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a~     new fixation method involving absorbable screws. The investigators aimed to determine if it~     is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing~     the functional outcomes obtained using screw fixation vs. K-wire fixation.~   "
24716|NCT02733653|"~     The purpose of this study is to evaluate the safety and effectiveness of the Jetstream~     Atherectomy System for the treatment of Japanese patients with symptomatic occlusive~     atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal~     arteries (PPA).~   "
24717|NCT02733640|"~     The investigators sought to evaluate the influence of pantoprazole, indicated as less~     effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with~     stratification of the population according to the presence of cytochrome (CYP) 2C19~     polymorphism.~   "
24718|NCT02733627|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1467335 in healthy male and female subjects following oral administration of multiple rising~     doses over 28 days.~      Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement~     biomarkers of BI 1467335 after multiple dosing.~   "
24719|NCT02733614|"~     18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to~     assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and~     civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a~     double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246~     for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for~     8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period~     between treatments. Subjects will be assessed at baseline and then every 2 weeks during the~     trial using the CAPS.~   "
24720|NCT02733601|"~     National, prospective, multicentre, non-interventional epidemiological study, conducted~     among oncologists and breast surgeons in community and university hospitals, from the public~     sector in Algeria.~      The study will collect information on the characteristics, and breast carcinomas patterns of~     patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study~     will be conducted over a representative, but not exhaustive sample of Algerian female~     patients.~   "
24721|NCT02733588|"~     The primary objective of this study is to test an optimized control system for sensor-guided~     (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical~     setting in patients with severe hypoglycemia following bariatric surgery.~   "
24722|NCT02733575|"~     This study aims to develop and test the feasibility of a new therapy called Compassion~     Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage~     distressing experiences by building internal feelings of safeness and affiliation, and by~     providing contexts, practices and insights that facilitate the development of compassion to~     self and others. The focus is on helping people feel safe in relation to their experiences~     and their social worlds. CFT is a promising new approach that has been successfully provided~     for people with a range of mental health difficulties. It is also firmly based in the most~     up-to-date knowledge and science about how the mind works (both normally and under stress).~      9 participants will be recruited from NHS psychological therapies services for people with~     psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short~     baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a~     clinical psychologist, and will provide interview and questionnaire research data at five~     different points during the study. At these assessment points, data will be gathered on~     participants' experiences, mood, perceptions of their position in the social world, and~     heart rate variability.~      The initial therapy protocol has been developed by psychologists with expertise in CFT,~     alongside people with lived experience of hearing voices and having distressing beliefs.~     However, it will continue to be developed and evolve as the study progresses, and as more is~     learnt (e.g. from the service-user participants) about applying the model in this~     population. At the end of this study, the aim is to have all the information needed to run a~     randomised controlled trial of this therapy.~   "
24723|NCT02733562|"~     Sleeve gastrectomy is one of the most common surgical procedures performed today for~     patients that undergo bariatric surgery. One of the primary reasons for morbid obesity is~     unhealthy eating habits and the belief that changes in those habits can ensure the success.~     Objectives: The investigators aimed to explore the effect of different eating habits prior~     to the bariatric surgery on the surgery success and on different aspect of quality of life.~     Design: The investigators conducted this study on patients that underwent sleeve gastrectomy~     as the first bariatric operation.~   "
24724|NCT02733549|"~     Dizziness is one of the most common complaints among patients admitted to the emergency~     department (ED). In most cases, the etiology remains unclear. Dizziness has a broad~     differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim~     of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver~     function tests for patients with SOD in the ED, and a cost analysis of liver function tests.~   "
24725|NCT02733536|"~     The investigators sought to compare the time to intubation and success rate of the~     endotracheal intubation using standard tracheal tube with Macintosh laryngoscope and video~     tube ETView SL in an adult cadaver model in three emergency scenarios.~   "
24726|NCT02733523|"~     Motivations:~      Socio‐economic and education determinants have a big impact on health outcomes, in terms of~     worse health status in populations living in more disadvantaged conditions. Social capital,~     self‐management and health literacy are some of the intermediate determinants, with the~     potential to mitigate health inequalities through interventions driven by local health~     agents. These three determinants are intensely interlinked and have, separately, impacts on~     self‐perceived health. Social capital is defined in this project as an umbrella concept,~     which includes quantitative aspects of social resources (structural social capital: social~     networks and contacts, social and civic participation) as well as qualitative or subjective~     aspects (cognitive social capital: perceived social support, feeling of belonging and trust)~     and covers relations between subjects at a micro or individual level (family and friends) as~     well as at a macro or community level. Health literacy is understood as cognitive and social~     skills which determine the motivation and ability of individuals to gain access to,~     understand and use information in ways which promote and maintain good health. Both are key~     aspects for self‐management behaviours. The target of our research project are older people~     living in urban socioeconomically disadvantaged areas, since ageing is in itself an~     inequality axis and urban environments concentrate the highest health disparities.~      Objectives: With the aim to reduce health inequality, an intervention has been designed to~     promote self‐management, health literacy and social capital among older people who perceived~     their health as fair or poor and are living in urban socioeconomically disadvantaged areas~     with the aim of improving their self‐perceived health. Secondarily, the efficacy of the~     intervention will be analysed in terms of increasing self‐management, health literacy and~     social capital (social support and social participation), quality of life, mental health and~     healthy lifestyles.~      In third place, behavioural health patterns will be identified in relation to health~     literacy, social capital, gender, socioeconomic and educational level, and they will be~     linked to the intervention efficacy levels.~   "
24727|NCT02733510|"~     -  The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on~          SCR revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.~        -  In our institution, since routine protocol biopsies are performed at 2 weeks, 1 year,~          and 2 years after renal transplantation, it is practically difficult that graft~          survival is used as an endpoint for randomized controlled trials.~        -  From a meta-analysis for 31 observational studies , acute rejection was associated with~          an increased risk of graft loss risk ratios ranged from 1.2 - 10.5. Furthermore,~          chronic allograft nephropathy and graft survival is strongly correlated with acute~          rejection episode during the first year after renal transplantation.~        -  Therefore, the aim of this study is to investigate the effect of early steroid pulse~          therapy for the reduction of acute rejection episode during the first year after KT in~          the patients who will show subclinical changes at 2-week protocol biopsy.~        -  The histological feature at 1 year PB, graft function (represented by serum creatinine~          level and eGFR) during the 1st year of KT were compared between SCR group and non-SCR~          group.~        -  Additional benefits including early detection of polioma BK virus associated nephritis~          (BKVAN) and relapsed underlying disease are also evaluated.~   "
24728|NCT02733497|"~     Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of~     the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy~     Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory~     to medical treatment .~      The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but~     anatomic studies have showed that accessory fibers from the T2 and T3 sympathetic ganglia~     come to the heart and influence its function.~      Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram~     to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found~     that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a~     shift of sympathovagal balance toward parasympathetic tone but remains unclear if these~     changes are associated with the extend of ETS.~      Thus, in the present study the investigator performed a prospective analysis of HRV function~     in patients with EPH undergoing different sympathetic denervations as sympathectomy and~     sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with~     the extend of sympathetic resection.~   "
24729|NCT02733484|"~     The purpose of this study is to determine whether the probiotics will be effective in the~     treatment of obesity~   "
24730|NCT02733471|"~     This study evaluates the efficacy and safety of the administration of lidocaine spray in~     oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while~     the other half will receive a placebo.~   "
24731|NCT02733458|"~     The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide,~     pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as~     first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell~     lymphoma, nasal type.~   "
24732|NCT02733445|"~     The purpose of this study was to determine how often and how likely patients are to develop~     Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy~     for Chronic Myelogenous Leukemia (CML).~   "
24733|NCT02733432|"~     The purpose of this study is to determine if two topical formulations of CD101 are safe and~     effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC)~     compared to oral fluconazole.~   "
24734|NCT02733419|"~     This is an open-label, randomized and multi-center study to compare the efficacy and safety~     of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with~     HIV-1 infection. Participants will receive an initial 28 week induction treatment with~     enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to~     (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will~     be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24~     weeks (up to Week 52).~   "
24739|NCT02733354|"~     Based on real cases, daily life scenarios of peritoneal dialysis and hemodialysis patients~     were shooted and edited into video films, including environment of home dialysis, dietary~     patterns, water intake, sports mode, daily work, short time of travel and other activities,~     covering a certain natural day of either peritoneal or hemodialysis and some important time~     points in the way of life, such as nursing and treatment for common complications of the~     corresponding dialysis mode. The videos will also show the advantages and disadvantages of~     the two modes of dialysis. According to their actual living conditions, patients will decide~     the right dialysis modality that suite them well, thus improving dialysis compliance and~     psychological adaptability.~   "
24740|NCT02733341|"~     Major heart attacks are caused by a number of factors, the two major of which are furring up~     of a coronary artery with atheroma and then sudden clot formation on this area leading to a~     blockage and interruption of blood flow. The clots that lead to heart attacks are largely~     made of clotting blood cells (platelets) that in health repair blood vessels and inhibit~     spontaneous bleeding. One of the main treatment strategies for heart attacks is to make~     these cells less sticky. Aspirin is a main stay of anti-platelet treatment in the United~     Kingdom (UK) and in addition one of three other oral antiplatelet agents acting on the same~     platelet activation pathway (P2Y12 receptor) is licensed for use. When a patient is admitted~     with a major heart attack, they are treated with emergency primary percutaneous coronary~     intervention (PPCI) a technique where a wire and balloon are used to reopen the coronary~     artery and then usually a stent (a slotted metal tube) is placed to keep the artery open.~     Aspirin and one of the P2Y12 inhibitor agents are given to prevent further clots and all~     have been shown to reduce negative events following heart attacks and angioplasty with stent~     insertion. There are increasing data, including from our own institution, showing that in~     the setting of heart attacks, the oral P2Y12 inhibitors are poorly absorbed and have little~     effect at the time of most need, i.e. soon after dosing while the primary PCI is being~     performed.~      All three current P2Y12 inhibitor agents are taken in tablet form immediately before the~     emergency PPCI procedure. It appears that in healthy stable patients these agents take at~     least 30 min to 2 hours to have an adequate effect. In heart attack patients the angioplasty~     procedure is usually performed well within this timescale. Furthermore, patients who are~     having a heart attack do not have normal drug absorption with blood being diverted away from~     the stomach and gut activity being suppressed by other drugs such as morphine.~      In this current study, patients with major heart attacks will be given our standard oral~     agent, Ticagrelor, or the newer intravenous agent Cangrelor prior to PPCI.~   "
24741|NCT02733328|"~     The study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing~     Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and~     multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6~     and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott~     and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline,~     or the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively~     (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5~     days. Clinical data collected will include patient demographics, co-morbidities, drug~     history, pre-operative renal function, surgery details (type, length, CPB time etc.), length~     of Intensive treatment unit and hospital stay and post-operative complications. Data will~     then be analysed comparing the two NGAL tests to find out which is superior, whether it is~     better to use blood or urine and to define optimal NGAL cut-offs and sample timing for~     predicting AKI. Both the Abbott and BioPorto assays will subject to a laboratory method~     evaluation prior to the analysis of any patient specimens in order to verify that their~     performance is acceptable and meets the manufacturer's claims. This will involve measuring~     the standard parameters used to assess laboratory assay performance e.g. imprecision~     (reproducibility), linearity, recovery and method comparison etc.~   "
24742|NCT02733315|"~     The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes~     management education program that has been shown to help patients adapt to their disease. So~     the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes~     patients in Taiwan.~   "
24743|NCT02733302|"~     The control of diabetes is related both to food, treatment but also to physical activity.~     Despite these recommendations and these positive findings, patients are always sedentary~     because of brakes in the practice of a regular physical activity.~      It is therefore interesting to consider the representations of patients and particularly on~     the way of establishment in order to reach a goal. The Hope Theory highlights the hope as~     the sum of the will and means that an individual has to achieve its goals. Will be discussed~     in this study to identify a relationship between the level of hope for patients and their~     ability to permanently change their behavior in regular physical activity as part of the~     goals set during the week of therapeutic education patient.~   "
24744|NCT02733289|"~     Standard evaluation and follow-up data regarding complications of curative radiation~     treatment for cervical cancer.~   "
24745|NCT02733276|"~     Fatigue is a common symptom in inflammatory bowel diseaseI and persists despite clinical~     remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F~     scale. Acupuncture has been shown useful in the treatment of fatigue in various chronic~     diseases.~      This study evaluates the effect of electroacupuncture in the treatment of fatigue in~     patients with quiescent inflammatory bowel disease.~      Patients with inflammatory bowel disease and severe fatigue (FACIT-F score <38) who agree to~     participate in the study will be randomized to three different treatments:~     electroacupuncture vs. sham electroacupuncture vs. control group.~   "
24746|NCT02733263|"~     Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal~     bulk by enhancing growth of specific microbial populations; however the effect of RMD on~     bifidobacteria and total fecal weight is not clear. The purpose of this research study is to~     determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce~     beneficial changes in gastrointestinal function, the fecal microbiota profile (increased~     number of healthy bacteria in stool) and immune processes resulting in improved quality of~     life.~   "
24747|NCT02733250|"~     The purpose of this study is to determine the optimal dose of nab-paclitaxel to be safely~     administered in combination with pembrolizumab in patients with advanced inoperable~     non-small cell lung cancer. The study is also aimed at evaluating the efficacy of the~     combination therapy.~   "
24748|NCT02733237|"~     To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of~     infidelity in males and females.~   "
24749|NCT02733224|"~     we intend to evaluate the association between non-adherence to Lenalidomide in Multiple~     Myeloma (MM) patients and overall response rates and time to progression (TTP).~      Adherence will be measured in several ways, including by electronic monitoring, which is the~     gold standard method.~   "
36725|NCT02576314|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir~     containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3~     infection.~   "
24750|NCT02733211|"~     The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes~     mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial~     glucose to aid in the management of their diabetes. The product automatically adjusts basal~     insulin delivery and delivers correction boluses in response to real-time glucose~     measurements by CGM to maintain blood glucose within the desired range, to improve metabolic~     control without increasing the risk of hypoglycemia.~      The proposed study is an open-label, two-center, randomized, cross-over study to evaluate~     the safety and efficacy of night closed-loop control using the MD-Logic automated insulin~     delivery system compared to sensor augmented pump therapy in poorly controlled patients with~     type 1 diabetes at home The objective of this pilot study is to evaluate the safety and~     efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly~     controlled type 1 diabetes at patient's home~   "
24751|NCT02733198|"~     To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration~     of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital~     and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with~     acute symptomatic pulmonary embolism (PE).~      Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with~     acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to~     receive usual care.~      Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals.~      Analyses: Data for the primary and secondary end points will be analyzed according to the~     intention-to -treat principle. The intention-to-treat analysis will include all randomly~     assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U~     test. We will also use competing risk regression models according to Fine and Gray. For the~     safety end points, comparisons will be made with the use of the chi-square test. Separate~     analyses will be done in key prespecified subgroups of patients, according to age and~     hospital size.~   "
24752|NCT02733185|"~     Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled~     factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and~     minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial~     infarction (MI).~   "
24753|NCT02733172|"~     The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients~     using functional and structural brain imaging together with genetic, physiological, and~     biological parameters.~   "
24754|NCT02733159|"~     This study is to determine that pembrolizumab is safe and tolerable at the selected dose for~     the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of~     2. All patients will receive pembrolizumab.~   "
24755|NCT02733146|"~     To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones~     in cardiac arrest patients.~   "
24756|NCT02733133|"~     This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of~     Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has~     been applied and the potential of product to raise serum androgen levels in those women.~   "
24757|NCT02733120|"~     The objective of this study is to gain preliminary information and knowledge on metabolic~     profile in ASD. The benefit of this study will be to expand our insight of the potential~     relationship in metabolic processes and neuropsychological functions in ASD. For example,~     based on the obtained data of the study we can determine whether there is a link between the~     tryptophan pathway and cognitive functions in autism. The project is based on a systematic~     and multidisciplinary approach using tracers for delineating the mechanism by which the~     metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD.~     Using an innovative approach to the evaluation of amino acids has not been used in adults~     with ASD. In addition, the obtained data of the study holds promise to develop specific~     markers (metabolic and/or neuropsychological) for guiding the identification those~     individuals with increased risk of developing mood disturbances or cognitive impairment, and~     for predicting the therapeutic effect of a specific nutritional interventions in subjects~     with ASD.~   "
24758|NCT02733107|"~     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer~     treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular~     endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung~     cancer which is recommended by NCCN guideline. The investigators wondered whether these two~     drugs have synergistic effects when treating advanced non-small cell lung cancer patients~     who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to~     investigate the efficacy and safety of apatinib combined with etoposide in heavily~     pretreated advanced non-small cell lung cancer.~   "
24759|NCT02733094|"~     The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17~     therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration~     until week 16) for the treatment of pyoderma gangrenosum.~   "
24760|NCT02733081|"~     This is a randomized controlled trial that compares traditional IUD insertion with that of a~     no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD~     placement is safe and effective without pre-procedural assessment of uterine size,~     direction, or depth.~   "
24761|NCT02733068|"~     A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection~     Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human~     Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy~     Females Aged 18-30 Years.~   "
24762|NCT02733055|"~     Determine the effects looking in certain direction or moving the eyes in a certain way have~     on the ability of a subject to maintain equilibrium in different circumstances (eyes~     open/closed, and standing on hard or compliant surface, with the head straight or rotated~     right or left, flexed or extended).~   "
24763|NCT02733042|"~     This open-label, multicenter, global study is designed to determine the recommended phase 2~     dose, safety, efficacy, and pharmacokinetics/pharmacodynamics of durvalumab in subjects with~     certain lymphoma subtypes or CLL. Globally, 253 subjects may be enrolled into 4 treatment~     arms, including durvalumab monotherapy; durvalumab in combination with lenalidomide±~     rituximab; ibrutinib; or rituximab ± bendamustine. The study will have 3 parts: dose~     finding, dose confirmation, and dose expansion. Subjects receiving monotherapy may receive~     combination therapy or involved-field radiation to a single nodal site at time of~     progressive disease.~   "
24765|NCT02733016|"~     Seinäjoki Adult Asthma Study is a single-centre 12-year follow-up study of a total cohort of~     259 patients having new-onset asthma that was diagnosed at adult age. The study was divided~     in two parts: the collection of the original cohort (phase I;n=259) and follow-up visit~     (phase II; n=203). The aim of this study is to increase the understanding on the diagnostics~     and diagnostic process, organisation of the long-term asthma care, therapeutic outcomes,~     prognosis and the factors affecting the prognosis of new-onset asthma diagnosed at adult~     age.~   "
24766|NCT02733003|"~     This study seeks to implement the Women's Health CoOp (Cooperative) (WHC) intervention into~     HIV treatment centers (HCT), antenatal, and substance treatment clinics in South Africa to~     translate the evidence-based intervention into real-world settings. Implementation, service,~     and patient outcomes will be evaluated through an iterative stepped wedge design.~   "
24767|NCT02732990|"~     Exercise intolerance is a major limiting symptom in patients with CHF. However the poor~     correlation between the hemodynamic parameters of left ventricular performance at rest and~     exercise performance has led to the concept that peripheral factors such as muscle perfusion~     and muscle metabolism play a role as determinants of exercise capacity.~   "
24768|NCT02732977|"~     Heart failure is a growing throughout pathology in Europe. It is a public health issue and~     an economic issue. The management to be effective needs to be early but specific. Generic~     treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years~     and has demonstrated its effectiveness, come s'ajouter solutions specific, technically~     complex and expensive to implement. Because of the potential risk to the patient and their~     cost to the company, these new techniques need to be adapted to each case. The passage of a~     generic simple treatment for everyone in the single treatment tailored to each patient~     requires decision support tools for the clinician. These tools or decision trees are~     developed using mathematical and statistical models fed by all patient data (imaging,~     biology physiology ...) before and after implementation of treatment. Predictive response~     models of a treatment applied to a particular pathology can thus be generated.~      It is this type of models applied in systolic heart failure complicated by mitral~     regurgitation and / or cardiac synchronization that will be generated in this project from~     150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we~     will include 30 patients in this single-center study~   "
24769|NCT02732964|"~     The aim of this study is to evaluate the effect of perioperative music on maternal anxiety,~     hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and~     overall maternal satisfaction.~      Investigators hypothesize that women exposed to perioperative music will have greater~     overall satisfaction with the delivery experience. Investigators also hypothesize that~     perioperative music will lower anxiety levels of women having a scheduled cesarean delivery,~     result in a less profound degree of spinal-induced hypotension prior to cesarean delivery,~     and result in a lower requirement of analgesics postpartum.~   "
24770|NCT02732951|"~     This is a proof of mechanism trial to explore the effect of BI 1026706 on the central~     retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally~     for 12 weeks in patients with mild vision impairment due to center-involved DME~   "
24771|NCT02732938|"~     The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of~     PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the~     dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309~     and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the~     enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine~     versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.~   "
24772|NCT02732925|"~     The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is~     more effective compared to conservative treatment alone (sham procedure) when assessing~     clinical, translational, radiological & patient outcomes in patients with multiple myeloma.~      Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed~     consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and~     Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects~     recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2~     (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12~     weeks.~   "
24773|NCT02732912|"~     The aim of this study is to determine whether routinely providing patients admitted to~     hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients~     having a better quality of sleep and/or longer, more satisfying sleep.~   "
24774|NCT02732899|"~     To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA~     in subjects with exudative age related macular degeneration (AMD) with persistent~     intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal~     antiVEGF treatment.~   "
24775|NCT02732886|"~     This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new~     dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients~     (35 each arm) are targeted to be enrolled in this study. The study will be conducted over 57~     days.~   "
24776|NCT02732873|"~     The REKREATE project will be an international, multi-centre, non-randomised, prospective~     single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold~     following the provision of informed consent. A study period of 1 year and extended follow up~     period of up to 3 years is planned , to enable a thorough and complete assessment of the~     performance of the device when implanted to replace removed or damaged meniscal tissue in~     humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold,~     which has been developed for repair of defects of the meniscus.~   "
24777|NCT02732860|"~     By obtaining clinical specimens from participants with triple negative breast cancer (TNBC),~     colorectal cancer (CRC) and other select tumor types to establish and profile as freshly~     implanted tumors in mice, the aim of this study is to identify agents with predicted~     activity in the host patient while also potentially providing them with personalized cancer~     treatment options~   "
24778|NCT02732847|"~     Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract~     infections (which are mostly viral).~      This trial will test the hypothesis that if the clinician post-dates the delayed~     prescription by 2 days, rather than dating it on the day the patient is seen, there will be~     a further drop in the rate of antibiotic use.~   "
24782|NCT02732795|"~     Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is~     estimated to comprise 530,000 procedures in children under 15 years of age. Historically,~     the leading cause for these procedures was recurrent infections; however, more recently~     surgical indications include sleep disordered breathing and obstructive sleep apnea (OSA).~     Pre-operative polysomnography (PSG) is recommended for all children with suspected OSA prior~     to undergoing AT, although it is unclear whether sleep disordered breathing characteristics~     predict post-operative outcomes or complications.~      Obesity has become an epidemic in our pediatric population. More recently, an increased~     population of obese children are presenting for AT with upper airway obstruction with or~     without tonsillar hypertrophy, which is similar to the adult etiology of OSA. Obesity is a~     multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism,~     insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers~     for inflammation, including TNF-α, CRP, leptin, IL-6 and IL-10, are abnormal in obese~     patients and have also been linked to more severe OSA disease in children even after~     controlling for BMI.~      In pediatrics, medication dosing is based on an actual body-weight calculation, however,~     recent reports suggest that this dosing method is over-dosing patients with obesity.~     Therefore, increased respiratory complications after surgery may be related to inappropriate~     intra-operative opioid dosing.~      Specific Aim 1 (SA1): To compare analgesic-guided opioid dosing using actual body weight~     (ABW) based dosing versus ideal body weight (IBW) dosing for adenotonsillectomy in children~     with OSA (BMI >/=75%).~      The investigators hypothesize that 1) weight-based opioid dosing compared to dosing based on~     ideal body weight leads to increased respiratory complications defined by (a) upper airway~     obstruction, (b) hypoventilation, and (c) oxygen desaturation without affecting pain scores~     immediately after adenotonsillectomy. In addition, the investigators believe 2) that there~     will be little statistically significant difference in pain scores between ABW and IBW for~     these patients.~      Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic~     inflammation, and OSA predict post-operative respiratory compromise after AT. The~     investigators hypothesize that inflammatory and obesity-related biomarkers are elevated in~     overweight children with OSA, more so in obese children with OSA, compared to lean children~     with OSA.~   "
24783|NCT02732782|"~     This is a prospective single blinded randomised controlled trial with a 12-week intervention~     period and a half-year follow-up period. The main purpose is to determine the effects of~     isometric exercise on mechanical, morphological and functional tendon properties versus~     eccentric exercise in chronic Achilles tendinopathy.~   "
24784|NCT02732769|"~     the Mask fixation isn't a new solution for the immobilization of the patient's head and has~     been used in current practice for long years.~      This trial is attempting to compare these two technical possibilities of head fixation by~     mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient~     and specifically for each step of the procedure. It will also evaluate other parameters such~     as the effectiveness of these two strategies and tolerance.The expected benefit is an~     improvement of the comfort for the patients.~   "
24785|NCT02732756|"~     Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than~     their typically developing peers. Observational studies indicate that inadequate sleep is~     correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is~     causally related to impairment. This study will use an experimental sleep restriction and~     extension protocol to evaluate sleep as a contributor to clinically significant impairment~     and possible target for intervention in adolescents with ADHD.~   "
24786|NCT02732743|"~     The primary objective is to assess the efficacy and safety of the Food Supplement~     Physiomanna® Baby in pediatric patients with a history of functional constipation~      The secondary objective of the trial is to evaluate the adherence to product's~     administration in the enrolled children.~   "
24787|NCT02732730|"~     To assess the acceptance rate, adherence, acceptability, and continuation of oral~     pre-exposure prophylaxis (PrEP) among young southern African women.~   "
24788|NCT02732717|"~     Recent years, women with infertility have become more and more and thus assisted~     reproductive technology has been applied in a broad range. And the quantities of twin~     pregnancies are larger and larger. However, complicated twin pregnancy subsequently~     increased including selective intrauterine growth restriction (sIUGR), twin growth~     discordance, twin transfusion syndrome (TTTS) and intrauterine fetal death (IUFD). The~     occurrence of complicated twin pregnancy has been the leading cause of morbidity and~     mortality in twin and mother. Meanwhile, twin pregnancy, especially monochorionic type has~     suffered from higher rate of chromosomal anomalies and structural anomalies. Therefore, it~     is important that more attention should be paid to the prediction, clinical evaluation and~     the occurrence of chromosomal anomalies and structural anomalies in complicated twin~     pregnancy.~      So far, prenatal ultrasound has been acknowledged as the best method for prenatal diagnosis~     and evaluation in twin pregnancy. By means of the application of prenatal ultrasound, the~     detection of fetal chromosome, and secondary correlation analysis, the investigators try to~     build prenatal ultrasound monitoring system of twin pregnancy and provide evidences for the~     choice of intervention and delivery time, in order to decrease the morbidity and mortality~     of twin and improve perinatal short and long outcomes.~      The goals of this study are as below: (1) primary goal: the prediction of complicated twin~     pregnancy by using prenatal ultrasound; (2) primary goal: the clinical evaluation of~     perinatal outcomes in twin pregnancy by using prenatal ultrasound; (3) secondary goal: the~     analysis of the correlation between prenatal ultrasound and fetal anomalies.~   "
24789|NCT02732704|"~     The purpose of this research study is to collect information about a new treatment for~     severe aortic regurgitation, which affects the aortic valve in the heart. Aortic~     regurgitation is a condition where the heart's aortic valve does not close tightly and~     allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may~     include fatigue and shortness of breath. The preferred treatment for severe aortic~     regurgitation is aortic valve replacement surgery. A less invasive surgical approach called~     TAVR is offered to those patients who are high risk for undergoing open heart surgery to~     replace the aortic valve. In this study, TAVR will be performed using the JenaValve~     Pericardial TAVR System, which is intended to help treat severe aortic regurgitation. The~     JenaValve replacement valve is placed inside the aortic valve by using the JenaValve~     delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1)~     transapical - where the valve is implanted through the chest wall, and (2) transfemoral -~     where the valve is implanted through an artery in the groin. The choice of which implant~     method will be used is decided by the doctor.~   "
24810|NCT02732431|"~     Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric~     practice, there is no way to determine the children with an increased risk. The aim of the~     study is to determine the reliability of four questionnaires used in pediatric patients in~     screening of OSA in Down syndrome children.~      Prospective study where patients are evaluated on airway diseases and aeroallergens~     sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by~     completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an~     overnight polysomnography (PSG), in University Hospital in Nice.~   "
24790|NCT02732691|"~     The purpose of this research study is to collect information about a new treatment for~     severe aortic stenosis, which affects the aortic valve in the heart. Aortic stenosis is a~     narrowing of the aortic valve opening, which decreases blood flow from the heart and causes~     symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for~     severe aortic stenosis is aortic valve replacement surgery. A less invasive surgical~     approach called TAVR is offered to those patients who are high risk for undergoing open~     heart surgery to replace the aortic valve. In this study, TAVR will be performed using the~     JenaValve Pericardial TAVR System, which is intended to help treat severe aortic stenosis.~     The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve~     delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1)~     transapical - where the valve is implanted through the chest wall, and (2) transfemoral -~     where the valve is implanted through an artery in the groin. The choice of which implant~     method will be used is decided by the doctor.~   "
24791|NCT02732678|"~     Adrenergic processes stimulated by epinephrine and norepinephrine drive to the development~     of tumor growth and metastasis. Beta-adrenergic receptor (BAR) antagonists have shown~     efficacy against melanoma, breast cancer and prostate cancer. The non-specific BAR inhibitor~     propranolol has been used as the gold standard treatment in pediatric patients with benign~     infantile hemangioma which express high levels of beta adrenergic receptors potentially~     explaining their sensitively to propranolol. BAR have been shown to be expressed across a~     diverse panel of vascular tumors, with the highest expression in malignant vascular tumors~     including angiosarcoma. Several reports indicate positive results from beta-blockade in~     patients with moderately threatening vascular tumors. It remains to be determined if more~     malignant vascular tumor such as the angiosarcomas are susceptible to propranolol. Besides,~     due to the lack of adequate therapies for angiosarcoma (doxorubicin or paclitaxel and~     finally cyclophosphamide in third line) and to the poor prognosis of this rare and~     aggressive tumor, there is a strong need for the development of treatments against this~     tumor type. Recently using a panel of angiosarcoma cell lines. demonstrate that~     beta-adrenergic inhibition blocks cell proliferation and induces apoptosis in a dose~     dependent manner. Moreover, using in vivo tumor models they demonstrate that propanolol~     shows remarkable efficacy in reducing the growth of angiosarcoma tumors. Based on these~     proofs of mechanisms in vitro and in vivo and due to the well established safety propranolol~     in humans, investigators propose to determine among a wide range of propranolol dose (80~     mg/d ; 120 mg/d and 160 mg/d) the optimal one based on bivariate efficacy-toxicity outcome~     in patients with angiosarcoma treated by cyclophosphamide. Because these two drugs have~     different pharmacological mechanisms, the aim is to determine the optimal dose of~     propranolol having the best systemic cardiovascular tolerability and the best potential~     antiangiogenic effect in addition with cyclophosphamide.~   "
24792|NCT02732665|"~     In this study, glycosaminoglycan (GAG) profiling in subjects first diagnosed with metastatic~     ccRCC is hypothesized to be useful in monitoring drug response and predict the outcome of a~     CT scan. To this end, regularly measured plasmatic and urinary GAGs in prospectively~     enrolled subjects will be correlated to drug response as evaluated by the designated~     clinician based on CT scans. A positive correlation indicates that this test can~     successfully detect patients that are not responding to treatment before the scheduled~     follow-up in which CT scans are performed. Data on the extent of metastasis (number of~     metastatic sites) will be collected to assess whether the biomarker level correlates~     accordingly.~   "
24793|NCT02732652|"~     In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion~     of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early~     actionable clinical decisions are desirable. For example to screen population at risk or to~     distinguish benign masses from RCC before patient is referred to surgery. To this end, the~     plasmatic and urinary GAGs will be measured in prospectively enrolled subjects and the~     resulting scores correlated to the post-surgical definitive diagnosis and eventual RCC size.~     A positive significant correlation is suggestive that GAG profiling can be used to guide~     clinical intervention in a subject at risk or referred to nephrectomy because of suspicion~     of RCC. The biomarker in patients with high risk RCC will be monitored to observe its~     correlation with disease progression. Also, the biological significance of this positive~     correlation will be evaluated using gene expression profiling. This data may also be used to~     improve further the diagnostic accuracy of the proposed biomarker.~   "
24794|NCT02732639|"~     This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon~     (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD).~     Treatment was followed by 24 weeks of treatment-free follow-up.~   "
24795|NCT02732626|"~     This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation~     lines in addition to pulmonary vein isolation may improve the outcome in patients with~     persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.~   "
24796|NCT02732613|"~     The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's~     recommendation based on the patient's ideal weight. But sometimes the patient is tall and~     slim, the actual weight is much less than the ideal weight. This phenomenon might affect the~     success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal~     Mask Airway size based on ideal weight could improve the success rate of insertion;~     therefore, this study was designed to prove whether this conclusion also applies to the tall~     and thin patients.~   "
24797|NCT02732600|"~     In August 2014, the White House issued an Executive Action mandating that 25 VA medical~     centers place Peer Specialists (Veterans recovered from mental illness who are trained to~     support other Veterans with mental illness) on Primary Care Teams. Research shows that the~     success of adding new staff to existing teams can be improved by outside aid and~     facilitation. This quality improvement project will evaluate whether providing expanded~     support to half of the Primary Care Teams will lead to better outcomes when compared with~     teams that do not get extra support.~   "
24798|NCT02732587|"~     The purpose of this alcohol-interaction pilot study is to provide information on the effect~     of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses,~     including stimulation, sedation, intoxication, body sway and physiological responses. The~     investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol~     related responses. This is a within subjects open label study in which the investigators~     plan to run 8 subjects to obtain 5 completers.~   "
24811|NCT02732418|"~     This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and~     compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5~     mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in~     the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle~   "
24812|NCT02732405|"~     To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients~     with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non~     responders to PR.~   "
24799|NCT02732574|"~     Respiratory dysfunction following cardiac surgery is well documented and due in part to the~     location of the incision and nature of the surgery. Post-operative pulmonary complications~     (PPCs) remain a significant problem following cardiac surgery, sometimes causing prolonged~     length of stay in hospital as well as increased morbidity and mortality; with the greater~     risk to older adults and individuals with obstructive lung disease. Positive expiratory~     pressure (PEP) therapy is thought to increase lung volumes and facilitate secretion~     clearance. The purpose of this study is to investigate whether the addition of oscillating~     PEP therapy to standard postoperative treatment is more effective in decreasing the~     incidence of PPCs and increasing functional capacity at time of discharge in 'high risk'~     patients undergoing elective cardiac surgery.~   "
24800|NCT02732561|"~     This is a trial of the use of cranial electrostimulating therapy for depression and anxiety~     among homeless adults.~   "
24801|NCT02732548|"~     This study is being conducted to collect data on the performance of Miromatrix Wound Matrix~     (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.~   "
24802|NCT02732535|"~     This study will determine the role of the NK cells before and after bariatric surgery. The~     investigators selected patients with NAFLD.~      A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.~   "
24803|NCT02732522|"~     To analyze whether there is a statistically significant difference in the modifications~     present in the uterine cervix 6 hours after administration of misoprostol 50 µg through~     vaginal versus sublingual routes.~   "
24804|NCT02732509|"~     The purpose of this study is to determine how chronic inflammation influences skeletal~     muscle protein metabolism and metabolic function in humans. The investigators will evaluate~     acute responsiveness to a single bout of exercise in men and women who are either lean or~     overweight/obese. The investigators will explore the relationship between circulating~     inflammatory markers and anabolic, proteomic, and transcriptional responses to acute~     exercise. The investigators will measure skeletal muscle protein synthesis in the~     postabsorptive state and in response to a single bout of exercise.~   "
24805|NCT02732496|"~     The investigators will conduct a randomized placebo-controlled trial of a computerized~     intervention targeting working memory in 30 children with comorbid~     Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).~   "
24806|NCT02732483|"~     Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases~     mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed,~     controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate~     is still high, even after successful hemostasis with APC or electrical coagulation.~     Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes~     than those who are not. So excellent bleeding control in gastric cancer is most important in~     GI hemorrhage of gastric cancer.~      Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its~     usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will~     try to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.~   "
24807|NCT02732470|"~     Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly~     affecting women and leading to organ damages especially skin, joints, kidneys, central~     nervous system and heart. In SLE, immune system dysfunction leads to autoantibodies,~     autoreactive T cells and pro-inflammatory cytokines production. These elements will initiate~     and maintain organ damages. Patients with SLE have disease flares followed by period of~     remission. Flares can occur because of stress, infections, surgery, pregnancy or ultraviolet~     exposition. Furthermore the chronic nature of SLE is an important factor of depression in~     these patients.~      Qi Gong is an ancient Chinese practice based on relaxation movements, posture and breathing~     in order to harmonize the body and mind. This practice improves the general state by~     reducing fatigue and improving sleep. The beneficial effect of Qi Gong in medicine has been~     studied in several diseases including cancer, diabetes, arterial hypertension and~     fibromyalgia. Qi Gong seems interesting in depressed patients but also to reduce stress in~     healthy subjects.~      The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients~     with SLE. Patients will have two lessons of 60 minutes per week for three months and a~     collective lesson of 90 minutes per week for three months. The teacher of Qi-Gong will~     evaluate adherence to the practice of Qi Gong every week. Clinical and biological data will~     be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. Different evaluation~     scores and neurotrophin levels will be collected at baseline and at 6th month.~   "
24808|NCT02732457|"~     The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell~     transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV~     immune response.~   "
24809|NCT02732444|"~     Chronic Obstructive Pulmonary Disease (COPD) patients in Long-Term Home Oxygen Therapy~     (LTOT) have a reduction in airflow that is not totally reversible. This obstruction may be~     associated with an abnormal inflammatory response of the lungs as a result of inhalation of~     toxic particles, particularly to cigarette smoke. Furthermore, COPD patients also present~     limited symptoms to physical exercise, significant extrapulmonary effects, including weight~     loss, nutritional abnormalities and skeletal muscle dysfunction. Hyperinflation has been~     identified as a major cause of dyspnea and is currently believed to be already present in~     the early stages of the disease, causing limitations in physical capacity. The progressive~     exertional dyspnea is most associated with impairment to activities of daily living,~     decreased quality of life and worse prognosis. Traditionally, the severity of COPD is~     defined by the degree of obstruction, as measured by forced expiratory volume in one second~     (FEV1) after bronchodilator use (post-BD) and can be classified as mild, moderate,~     moderately severe and very severe disease. In the group of patients with Advanced Pulmonary~     Disease (APD), those with partial pressure values of oxygen (PaO2) lower or equal to 55mmHg,~     or arterial oxygen saturation (SaO2) lower or equal to 88% in ambient air; or those with~     PaO2 values between 55-60 or SaO2 lower than 90%, with evidence of pulmonary hypertension or~     polycythemia require LTOT, over 15 hours / day, with evidence of increased survival. The aim~     of this study is to evaluate the erythrocyte membranes stability in COPD and APD patients in~     LTOT compared to healthy subjects. It is a cross-sectional, observational study with~     evaluation of erythrocyte membranes stability among the groups as well as lung function,~     physical testing, laboratory analysis, oxidative stress and quality of life questionnaires.~     As red blood cells are the cells responsible for the gas exchange in the lungs and~     peripheral tissues, and since the patients with COPD and APD have gas exchange impairment~     compared to the healthy group, it is expected to find a difference in erythrocyte membranes~     stability and levels of oxidative stress among the groups.~   "
24874|NCT02731599|"~     The first aim of this study was to evaluate the effect of a gait training using treadmill~     with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim~     was to compare the obtained data of these patients in advanced stages with those in mild to~     moderate stages.~   "
24813|NCT02732392|"~     The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a~     prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is~     a very important element in the coverage (care). He allows to determine the local extension~     of the disease and the type(chap) of therapeutics to implement(operate) after the surgery.~     The standard cleaning out at present recommended by the European company (society) of~     urology at the patients at intermediate or high risk of second offense (recurrence) after~     local treatment(processing), has to concern the obturating pit, the internal and external~     iliac territories. However this type(chap) of cleaning out does not seem to solve all the~     problems of locoregional stratification. Indeed, several studies concerning the~     radio-controlled cleaning out highlighted that 10 in 30% of ganglions.~   "
24814|NCT02732379|"~     The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or~     ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in~     patients with postoperative nausea and vomiting.~   "
24815|NCT02732366|"~     The purpose of this study is to test the feasibility and preliminary efficacy of a~     group-based fall prevention program for older adults.~   "
24816|NCT02732353|"~     To measure the absorption kinetics and postprandial amino acid availability after ingestion~     of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle~     protein synthesis and the postprandial muscle protein synthetic response to minced beef and~     hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein~     synthetic response is measured and compared during the early postprandial period (0-3 hours)~     after ingestion of the two meat products.~   "
24817|NCT02732340|"~     The purpose of this study is to compare triple-branched stent placement with hemi-arch~     replacement in the treatment of acute DeBakey I aortic dissection . The investigators design~     a prospective, multi-center, randomized, open-label, parallel-group, optimal effect~     comparative clinical trial.~   "
24818|NCT02732327|"~     This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam~     (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or~     linezolid as empiric therapy in febrile neutropenic adults with cancer.~   "
24819|NCT02732314|"~     This is a 13 week randomized, double blind, parallel group, in home use study among~     approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic~     dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease~     severity, age, and body location of AD lesions. The study will consist of a 1 week washout~     phase and 12 week treatment phase. During the washout phase, subjects will be provided with~     a bar soap for bathing and showering and must refrain from using any other products on their~     body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens,~     etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout~     the treatment phase, the subjects will be required to use only the provided bar soap for~     bathing and showering and will apply their test product twice per day, once in the morning~     and once in the evening. No additional creams, moisturizers, lotions or cleansers other than~     those provided will be permitted for the duration of the study. Normal facial or hair care~     products are permitted, however, they must not contain anti-bacterial ingredients (e.g.~     antidandruff shampoo, acne products, etc).~      SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline~     visit, subjects will have an active inflammatory lesion site and adjacent non-lesion,~     non-inflammatory site identified and marked for all instrumental and biopsy evaluations at~     Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and~     self-assessments will be performed throughout the study. Tolerability will be evaluated by~     incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site~     reactions/infections, and lab evaluations throughout the study. There will be additional~     consumption and compliance checks as well as dermatologic evaluations to ensure the~     subject's condition does not become extensively worse at each visit. A subset of subjects~     will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3~     time points throughout the study. The subset of subjects will be determined by subject~     willingness to participate in the biopsy portion as well as dermatologic evaluation and~     determination of biopsy candidacy.~   "
24820|NCT02732301|"~     The purpose of this study is to investigate the frequency and grade of gastrointestinal~     dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers~     of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery~     requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked~     for participation in this study. All participating patients sign informed consent at the~     inclusion. The first three postoperative days the function of the gastrointestinal tract is~     scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma~     blood samples are collected from each patient preoperatively and the first three~     postoperative days. The plasma samples are stored in a biobank for later determination of~     plasma proteins. In the analysis, the patients are divided according to the gastrointestinal~     rating scale and the plasma protein expression, gastrointestinal complications and all-cause~     mortality are compared between the groups.~   "
24821|NCT02732288|"~     Patients with severe brain injuries often have slow accumulating recoveries of function. In~     ongoing studies, we have discovered that elements of electrical activity during sleep may~     correlate with the level of behavioral recovery observed in patients. It is unknown whether~     such changes are causally linked to behavioral recovery. Sleep processes are, however,~     associated with several critical processes supporting the cellular integrity of neurons and~     neuronal mechanisms associated with learning and synaptic modifications. These known~     associations suggest the possibility that targeting the normalization of brain electrical~     activity during sleep may aid the recovery process. A well-studied mechanism organizing the~     pattern of electrical activity that characterizes sleep is the body's release of the~     substance melatonin. Melatonin is produced in the brain and released at a precise time~     during the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep~     process each day. Ongoing research by other scientists has demonstrated that providing a~     small dose of melatonin can improve the regular pattern of sleep and help aid sleep~     induction. Melatonin use has been shown to be effective in the treatment of time change~     effects on sleep (jet lag) and mood disturbances associated with changes in daily light~     cues such as seasonal affective disorder. We propose to study the effects of melatonin~     administration in patients with severe structural brain injuries and disorders of~     consciousness. We will measure the patient's own timing of release of melatonin and provide~     a dose of melatonin at night to test the effects on the electrical activity of sleep over a~     three month period. In addition to brain electrical activity we will record sleep behavioral~     data and physical activity using activity monitors worn by the patients. Patient subjects in~     this study will be studied twice during the three month period in three day inpatient visits~     where they will undergo video monitoring and sampling of brain electrical activity using~     pasted electrodes (EEG), hourly saliva sampling for one day, and participation in~     behavioral testing.~   "
24822|NCT02732275|"~     This will be a First-in-Human, Phase 1, multi-center, non-randomized, open label study of~     DS-3201b, Histone-lysine N-methyltransferase EZH1/2 dual inhibitor to assess its safety and~     tolerability, identify a maximum tolerated dose (MTD)/ tentative recommended phase 2 dose~     (RP2D), and assess its pharmacokinetic/dynamic properties in Japanese subjects with~     Non-Hodgkin's Lymphoma.~   "
24823|NCT02732262|"~     Postoperative pain control is required after major abdominal surgery, including laparoscopic~     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain~     control mainly in Europe.~      The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain~     control after laparoscopic colorectal surgery in Korean.~   "
24826|NCT02732223|"~     Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and~     multifactorial disease triggered especially due to high level of plasma lipids and that~     involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress.~     Taking into account the high costs of disease management, eminent suboptimal response and~     low compliance to drug therapies, the combined use of natural bioactive compound able to~     reduce atherosclerosis risk could provide an additional protection. In this study, the~     effects of three bioactive components, namely omega-3 fatty acids, plants sterols and~     polyphenols present in green tea, will be evaluated over atherosclerosis biomarkers in~     individuals with dyslipidemia controlled by drugs. It will be carried out a randomized,~     double-blind, placebo-controlled, crossover clinical study, with participation of 70~     subjects. At each intervention period, study participants will receive a packaged for the~     functional or placebo treatment. Functional treatment packaged will be composed by omega 3~     softgels (fish oil), a chocolate containing plant sterols and green tea. Placebo treatment~     will be composed by corn oil softgels, regular chocolate, and anise tea. Subjects will be~     advised to consume the softgels and chocolate twice a day after main meals and to drink two~     cups of tea per day. After evaluation of inflammation, dyslipidemia and oxidative stress~     biomarkers, subjects with the greatest response to the functional treatment will be selected~     for additional 6 weeks of functional intervention associated to a reduction of the~     hypolipidaemic drugs intake, which will be prescribed individually after evaluation of the~     responsible physician.~   "
24827|NCT02732210|"~     The objective of this study was to describe persistence with Prolia® 60 mg administered~     subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.~   "
24828|NCT02732197|"~     Background: This study was designed to investigate the effect of sedation on the occurrence~     of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1~     Cesarean section (C/S) under spinal anesthesia.~      Methods: After institutional ethics committee approval, prospectively collected data of 1824~     parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores~     (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with~     thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included~     in the analysis. Hemodynamic parameters were documented and maximum systolic arterial~     pressure (SAP) reductions from the baseline after spinal anesthesia were calculated.~     Incidences of hypotension (SAP≥30% decrease from baseline or <100 mmHg) and bradycardia~     (HR<55 beats/min), and related-ephedrine and -atropine requirements were noted. Our primary~     endpoint was to compare the maximum SAP reductions from the baseline values in Groups S and~     NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine~     and atropine doses, newborn Apgar scores at 1st and 5th min.~   "
24829|NCT02732184|"~     This is the first study of the safety of increasing dose levels of AEB1102 in patients with~     Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will~     also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid~     levels and the antitumor effects of AEB1102.~   "
24830|NCT02732171|"~     This is a single center, prospective cross-sectional study of women who have completed~     therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for~     relapse.~      Patients will undergo screening bone marrow aspirate to test for presence of disseminated~     tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment~     into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).~   "
24831|NCT02732158|"~     This prospective, nonrandomized, feasibility study will compare laboratory measures at the~     beginning and end of the study period in adults consuming a nutritional study product.~   "
24832|NCT02732145|"~     To determine the sensitivity and specificity of Three Rings Vulvoscopy for detection of~     vulvar dermatosis using histopathology as the reference standard.~   "
24833|NCT02732132|"~     The primary aim of this study was to investigate the efficiency and safety of midazolam plus~     ketamine versus fentanyl plus propofol administered to children undergoing UGE and to~     determine the most appropriate sedation protocol.~   "
24834|NCT02732119|"~     The purpose of this study is determine if the triplet combination of ribociclib, everolimus~     and exemastane is effective in the treatment of locally advanced/metastatic breast cancer~     following treatment with a CDK 4/6 inhibitor~   "
24835|NCT02732106|"~     Human adipose tissue is now recognized as an acceptable, highly abundant source of~     adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of~     cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and~     vessel-associated cells. Autologous adult regenerative cells are thought to promote healing~     of scarred or injured tissue. While the investigators are learning more about the exact~     mechanisms every day, it is believed that this heterogeneous population of cells influences~     the local environment via cell-to-cell signaling, immune modulation, and differentiation~     into other cell types. The use of ADRCs in the treatment of many different medical~     conditions (including cardiovascular disease, soft tissue defects, wound healing, and many~     more) is being evaluated in numerous clinical and preclinical studies around the world.~     While there is a considerable amount of information regarding the cellular composition of~     ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC~     composition from cardiac patients. In this study, adipose tissue or cells from chronic heart~     ischemia patients, that would otherwise be thrown away in waste, will be provided to~     researchers who will study these cells with the objective to characterize ADRCs derived from~     patients with a heart disease and to compare if a heart disease state does impact ADRC cell~     composition.~   "
24836|NCT02732093|"~     In this study investigators will evaluate the effect of stellate ganglion block on stress~     response of intubation in comparison to traditional antistress measures in adult patients~   "
24848|NCT02731937|"~     The main purpose of this study is to collect clinical raw scan data and Scanner user~     feedback using dual energy CT (computed tomography) scan modes on the investigational CT~     scanner. Additionally, image quality using prototype reconstruction algorithms that are in~     development will be evaluated and compared to standard-of-care images acquired with~     regulatory cleared diagnostic CT scanners for feasibility assessment and engineering~     development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy~     (kV) scanning s provides more information about the material composition of the scanned~     patient and may allow for improved tissue, tumor characterization, and improved image~     quality.~   "
24837|NCT02732080|"~     After reopening of the infarct related artery by primary percutaneous coronary interventions~     (PPCI), microvascular damage at the related myocardial territory is not terminated~     immediately. This ongoing nature of microvascular damage leading to myocardial malperfusion~     is related to final infarct size. However, time course of the microvascular impairment~     /obstruction after PPCI in patients presented with ST-elevating acute myocardial infarction~     (STEMI) is not known. Routine primary percutaneous coronary interventions (PPCI) for~     ST-elevation acute myocardial infarction (STEMI) includes balloon angioplasty (or~     thrombectomy) followed immediately by stent implantation. However, stent implantation~     performed in this thrombotic setting may lead to a further microvascular damage by causing~     more distal embolisation and by inducing distal microvascular spasm by stretching the~     coronary vessel wall. Furthermore, sudden exposure of distal microcirculation to a high~     distal intracoronary pressure achieved by immediate stent implantation may exaggerate~     myocardial oedema which contributes microvascular damage substantially by external~     compression. However, results of studies investigating the efficacy of delayed stenting~     (24-48 hours later) in patients in whom TIMI -3 flow was achieved after balloon angioplasty~     were inconsistent.~      In this study, STEMI patients undergoing PPCI, in whom epicardial reperfusion was achieved~     (TIMI-3 flow) by wire crossing or by balloon angioplasty or aspiration thrombectomy, will be~     randomised to immediate and delayed stenting groups. Delayed stenting will be performed at~     the time when coronary auto regulation was recovered which is going to be determined based~     on the continuous intracoronary hemodynamic monitoring after reperfusion.~   "
24838|NCT02732067|"~     Death rate in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients.~      In this study, the investigators will follow the death among patients who underwent surgery~     under anesthesia whether regional or general over the next two years from 2016 to 2018.~   "
24839|NCT02732054|"~     This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in~     HIV-infected adults with low CD4 cell count in northern Thailand.~   "
24840|NCT02732041|"~     Asynchrony during mechanical ventilation has been poorly described in patients suffering~     from acute respiratory distress syndrome. The purpose of this study is to describe the~     frequency of asynchronies (ineffective efforts and double triggering) in these group and~     evaluate potential risk factors and prognosis implications.~   "
24841|NCT02732028|"~     Background: Summary of Findings (SoF) tables have been developed to present results of~     systematic reviews in a concise and explicit format. Adopted by many review groups including~     the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the~     GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable~     judgments about the certainty of evidence and magnitude of effects. Currently, there are~     three different SoF formats in use. This study aims to compare SoF table formats in terms of~     understanding, accessibility, satisfaction, and preference with systematic review users.~      Methods: The primary objective of this three-arm randomized control non-inferiority trial is~     to investigate the understanding of information presented in three different SoF tables: a~     new current GRADE-SoF table, a new alternative GRADE-SoF table, and EPC-SoF table with~     systematic review users. Researchers, clinical practice guideline developers, policy-makers,~     end-users, or knowledge transfer will be recruited. Data will be collected electronically at~     baseline and after randomization.~      Discussion: This study aims to assess the understanding, accessibility, satisfaction, and~     preference between three SoF tables for displaying summary evidence from health-related~     outcomes. The results of this study will provide important knowledge to understand what~     information should be included in SoF tables in systematic reviews.~   "
24842|NCT02732015|"~     The goal of this clinical research study is to compare rolapitant with fosaprepitant in~     controlling or preventing nausea and/or vomiting that may be caused by chemotherapy in~     patients with sarcoma.~   "
24843|NCT02732002|"~     Work-related injuries of the shoulder complex represent a challenge for clinicians due to~     the large variety of clinical entities involved and the broad anatomic structures that are~     potentially affected. Furthermore, commonly performed orthopedic tests have demonstrated~     limited accuracy for the actual diagnosis of the injury. Although considerable research has~     been performed to standardize a model for shoulder injury management, a comprehensive~     approach integrating both a clinical and functional based status of the pathology and~     adapted rehabilitation prescription remains lacking.~      The present study protocol aims to complement previously published shoulder injury~     management algorithms. Potentially, the multi-component, individualized and progressive~     multi-etiologic shoulder injury management model for rehabilitation could become a new~     effective strategy for reducing the time required to regain functional capacity and symptom~     recovery among patients with work-related shoulder injuries.~   "
24844|NCT02731989|"~     In addition to the manual preoperative examination, the undescended testicle will be~     measured ultrasonographically. The compared data will help us to evaluate the routine need~     for preoperative ultrasonographic evaluation of the undescended testicle.~   "
24845|NCT02731976|"~     Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD)~     for four weeks were studied. Per participant, nine stool samples were collected: one at~     baseline, four during the GFD period, and four when they returned to their habitual diet.~     Microbiome profiles were determined using 16S rRNA sequencing and the samples were next~     processed for taxonomic and imputed functional composition. Additionally, participants kept~     a 3-day food diary and six gut health-related biomarkers were measured.~   "
24846|NCT02731963|"~     Colorectal surgery is highly associated with septic complications, therefore, multiple~     approaches have been used to reduce this complications, one of the most used is mechanical~     bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation~     might not be necessary.~   "
24847|NCT02731950|"~     Effective pain relief after cardiac surgery has assumed importance with the introduction of~     fast track discharge protocols that requires early weaning from mechanical ventilation.~     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of~     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical~     wound has shown to improve early postoperative pain in various surgical procedures.~      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in~     animal and human models of pain.~   "
24849|NCT02731924|"~     The primary purpose of this study is to determine the accuracy of ultrasound (US) in~     diagnosing appendicitis in emergency department (ED) patients, as compared to the criterion~     standards of computed tomography, operative reports, or discharge diagnosis.~      The secondary purposes of the study include evaluation of the effect of ultrasound for~     appendicitis on the patient length of stay in the emergency department, the diagnostic~     utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body~     mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound~     findings to the Alvarado score. The study will also examine the inter-rater agreement~     between point-of- care sonographers' interpretation and blinded reviewers' interpretation of~     the ultrasound images.~   "
24850|NCT02731911|"~     This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in~     clinical practice.~   "
24851|NCT02731898|"~     A prospective, international and multicenter, non interventional single-cohort study, which~     will enroll consecutive adult patients who have received mechanical ventilation (invasive~     and noninvasive ventilation) for at least 12 hours during a 1-month period, and will follow~     each patient for the duration of mechanical ventilation, up to 28 days. The main objectives~     will be to analyze the mortality and clinical outcomes in ventilated patients and secondly,~     to evaluate the practices of liberation from mechanical ventilation, the failure of non~     invasive ventilation in the ICU, and to analyze the clinical outcomes in specific~     populations of critically ill patients with the need of mechanical ventilation.~   "
24852|NCT02731885|"~     The goal of this study is to determine the impact of the food on the absorption of the~     ABX464.~   "
24853|NCT02731872|"~     The purpose of our study is to establish whether domiciliary use of the Airvo warm passover~     humidifier can reduce the number of exacerbations in patients with respiratory~     insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease~     (COPD) and be in long term oxygen therapy (LTOT). The following questions will be~     investigated:~      Do outpatients receiving long term oxygen therapy benefit if this is delivered through an~     Airvo humidification system. The proposed benefits under investigation are:~        1. a reduction in the number of exacerbations and thus hospital admissions?~        2. an increase in quality of life (QOL)?~        3. an improved lung function and thus increased physical activity?~   "
24854|NCT02731859|"~     The purpose of this study ist to determine long-term safety and efficacy in weight reduction~     and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal~     bypass-sleeve EndoBarrier® in a national registry.~   "
24855|NCT02731846|"~     The primary purpose of this study is to assess the equivalence of closed triple therapy~     Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) to open triple therapy (FF/VI +~     UMEC), with a comparison of both triple therapies to dual therapy (FF/VI) on lung function.~      This is a phase III, 4-week, randomized, double-blind, parallel group, multicenter study~     comparing FF/UMEC/VI (100 micrograms [mcg]/62.5 mcg/25 mcg) delivered via a single ELLIPTA®~     inhaler ('closed' triple) + matching placebo ELLIPTA inhaler, FF/VI + UMEC delivered via two~     ELLIPTA inhalers ('open' triple) and FF/VI via a single ELLIPTA inhaler + matching placebo~     ELLIPTA inhaler, all once daily. The total duration of subject participation will be~     approximately 7 weeks, consisting of a 2-week run-in period, 4-week treatment period and a~     1-week follow-up period.~      ELLIPTA is a registered trade mark of the GSK group of companies.~   "
24856|NCT02731833|"~     This single centre, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice~   "
24857|NCT02731820|"~     The purpose of this study is to investigate whether the use of alkali compounds, i.e.~     potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression~     of osteopenia.~      A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to~     evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).~      The efficacy will be evaluated by comparing the circulating levels of bone turnover markers~     at the baseline and after the treatment (3, 6 months).~   "
24858|NCT02731807|"~     This study is a pilot research study in humans to determine the steady state pharmacokinetic~     profile of TA-65 after oral dose of formulated and unformulated forms. There will be eight~     (8) subjects of healthy men and women (non-child bearing). TA-65 is supposed to supplement~     the diet to increase general health through telomerase activation.The active ingredient in~     TA-65 activates an enzyme called telomerase. However, the active ingredient has poor oral~     bioavailability in humans. This study is created to enhance the bioavailability in~     telomerase with different formulations; powder and capsule form.~   "
24859|NCT02731794|"~     The investigators designed the randomized prospective study to evaluate the differences of~     inflammatory response and clinical outcome after on-pump beating coronary artery bypass~     grafting undergoing left ventricular assist versus biventricular assist in patients with~     severe left ventricle dysfunction.~   "
24860|NCT02731781|"~     Traumatic brain injury (TBI) is the major cause of disability and death among the younger~     population. In the Pediatric population Head trauma may be responsible for primary and~     secondary brain damage. Primary brain injury results from a direct mechanical damage at the~     time of injury, whereas secondary injury is caused by further cellular damage that develops~     hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in~     the abcence of neurological deficit or early deterioration. On the other hand, symptoms such~     as vomiting and restlessness may be present even in the case of minor head injury, and~     unnesessary scaning (CT) may be performed in many centers just because clinical judgment is~     problematic in this particular age. Some intracranial injuries may be imminent, such as~     evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and~     leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for~     emergency evaluation of head injured patients. In children, several scores were introduced,~     including the Children's Coma Score (CCS), however they have been found problematic to use~     in the very young population, since accurate evaluation of communication in CCS is hard, and~     there is insufficient relevant parameters uncorporated into the score that may have~     significant importance in this particular age group. In TINS (Trauma Infant Neurological~     Score) we characterized the clinical parameters and the mechanism of trauma in a simplified~     method. As previously published, this score has been used by us and by other groups, in~     retrospective studies. Still, in the lack of prospective studies using TINS, there are no~     optimal guidelines to perform computed tomography (CT) in this unique population, and TINS~     has not prospectively been challenged as a predictor tool for outcome. In this prospective~     study we will approach these issues.~   "
24861|NCT02731768|"~     The purpose of this study is to evaluate whether a social support-enhanced,~     technology-based, behavioral weight control intervention can improve weight loss over~     existing best practices.~   "
24862|NCT02731755|"~     A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole~     grains contain a wide range dietary components including potentially vasoactive phenolic~     acids. In this proposed human trial, the investigators aim to establish whether consumption~     of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h~     post-intake) in markers of cardiovascular disease risk relative to an energy matched control~     intervention in healthy men with high-normal to mildly elevated blood pressure.~   "
24863|NCT02731742|"~     This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the~     treatment of advanced malignancies. The study will include an initial Dose Evaluation phase~     to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating~     Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following~     determination of the MTD/MAD, approximately 20 participants each will be enrolled in two~     expansion cohorts to confirm/refine the MTD/MAD.~   "
24864|NCT02731729|"~     The purpose of this research study is to learn whether patients whose disease grows after~     being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in~     combination with nivolumab (Opdivo®).~   "
24865|NCT02731716|"~     To design an innovative payment system that improves upon fee-for-service (FFS),~     incorporates behavioral economic principles, and improves work satisfaction among primary~     care physicians (PCPs) while improving quality and reducing health spending at the state~     level. Second, to test the incremental effectiveness of two additional interventions: (1)~     shared financial incentives between physicians and poorly controlled diabetes and (2) social~     comparisons ranking physicians on quality metric performance and total cost of care.~   "
24866|NCT02731703|"~     This study will identify and enroll patients already scheduled to receive guided maxillary~     implant placement with palateless overdenture. Standard clinical practice will be followed~     for this multi-stage process. The study purpose is to evaluate the degree of satisfaction~     during the standard progression in order to determine at which post edentulous stage~     patients achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).~   "
24867|NCT02731690|"~     This is an open-label multi center study to evaluate the safety of Aceneuramic Acid Extended~     Release (Ace-ER) Tablets for patients with GNE Myopathy.The primary objective of this Phase~     2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM subjects with severe~     ambulatory impairment. The study will also assess efficacy to ensure that the full spectrum~     of patients with GNEM are evaluated.~   "
24868|NCT02731677|"~     Sleep disorders correspond to a non-motor symptom present in DP, being represented by~     daytime sleepiness and maintenance insomnia. This study aims to evaluate the effects of~     acupuncture on sleep disorders in patients with PD assisted by Pró-Parkinson Program at~     University Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the~     Ethics Committee for Research with Human. It was included patients with diagnosed with~     Idiopathic Parkinson's disease, Mini Mental State Examination (MMEE) according to education,~     stages 1, 2 and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's~     disease (PDSS), a self-administered scale designed to assess nighttime sleep problems, sleep~     disorders and excessive daytime sleep. Twenty-two subjects were allocated in two groups:~     experimental and control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5~     - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental~     group. The control group no suffered intervention. The paired analyzes were performed using~     the Wilcoxon test and the independent analyzes using the Mann-Whitney test.~   "
24869|NCT02731664|"~     The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach,~     duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of~     action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper~     gastrointestinal tract in man.~   "
24870|NCT02731651|"~     Laparoscopic surgery has played a pivotal role in all surgical fields in modern medicine. It~     has some well known advantages over open surgery. For this reason laparoscopic surgery is~     know the first choice for many surgical procedures, even in gynecology. On the other hand,~     despite the advantages of laparoscopy carbon dioxide (CO2) pneumoperitoneum is not free from~     side effects. Experimental studies and limited clinical studies showed that pneumoperitoneum~     leads to a decrease in the blood flow to intra-abdominal organs during laparoscopic surgery.~     This is also known as ischemia, leads to the production of free O2 radicals. The~     desufflation of the abdominal cavity at the end of the procedure reduces the increased~     abdominal pressure and increase the perfusion of intra-abdominal organs. However this will~     not stop the production of free radicals. This reperfusion period even exaggerate the~     release of free radicals. This phenomenon is called as ischemia/reperfusion (I/R) model that~     leads to release of various free radicals, which are the most important mediators of~     oxidative tissue injury and consequential organ dysfunction. Recently both oxidative tissue~     injury and consequential dysfunction have been shown in ovarian tissue in experimental~     animal studies. But the data related to human ovary is still scarce. Thus the aim of the~     study is to evaluate the effect of I/R injury related to CO2 pneumoperitoneum on human~     ovary.~   "
24871|NCT02731638|"~     Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical~     trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.~     There is currently little evidence to guide the treatment of fungal keratitis beyond topical~     anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used~     as well. This study will provide evidence to guide the treatment of fungal keratitis in the~     future. The purpose of this study is to determine differences in microbiological cure for~     3-day repeat cultures between different antifungal treatments. For this study, there will be~     1:1 randomization to one of these two treatment groups: 1) topical natamycin plus~     intrastromal voriconazole injection or 2) topical natamycin alone.~   "
24872|NCT02731625|"~     The purpose of this study is to investigate the performance benefits of supplementing Army~     standard Physical Readiness Training (PRT) with a defined kettlebell (KB) deadlift and swing~     training program as compared to standalone PRT. Power and performance will be measured on~     horizontal (broad) and vertical jumps, 40 yard sprint, 60 yard shuttle, and the Army~     Physical Fitness Test (APFT). It is hypothesized that the unique force distributions of~     kettlebell training will promote improved power, particularly across the horizontal plane,~     when compared to standalone Army PRT. Findings will potentially provide insight as to how~     Army units can effectively utilize kettlebells to further diversify their training programs.~   "
24875|NCT02731586|"~     As Regenerative Medicine is the next level in medicinal sciences, the use of mesenchymal~     cells have become prevalent, Similarly now stem cells are being used in dental research as~     well in various clinical applications.This study aims to evaluate the overall effect of~     osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental~     implants.Healthy subjects will be chosen and dental implants placed bilaterally one with~     standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cells.The~     implant stability is checked using Resonance frequency analysis(RFA).The RFA values are~     statistically evaluated at various intervals and observations will be analysed on both test~     and control side.~   "
24876|NCT02731573|"~     This study is aimed to assess the safety as well as the anti-infective efficacy of D-PLEX~     over a period of 3 months post operation, by preventing primary sternal infection post~     cardiac surgery in patients above the age of 18, including high risk patients for infection.~      This study is a single arm, open label study.~   "
24877|NCT02731560|"~     A study to determine the efficacy and safety of rituximab in Pakistani patients with~     rheumatoid arthritis (RA) who have been inadequately controlled with standard disease~     modifying anti rheumatic drugs (DMARDs).~   "
24878|NCT02731547|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents~     in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the~     change in smoking prevalence between the two groups.~   "
24879|NCT02731534|"~     The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated~     Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with~     Iron-deficiency Anemia (IDA)~   "
24880|NCT02731521|"~     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma~     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in~     isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.~   "
24881|NCT02731508|"~     Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may~     restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and~     suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance~     after-effects of rehabilitation. In this double-blind, randomized controlled trial,~     investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary~     motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor~     functional outcome, ipsilesional motor circuit excitability using transcranial magnetic~     stimulation (TMS) and magnetoencephalography (MEG) measures.~   "
24882|NCT02731495|"~     Traumatic brain injury is the leading cause of death and disability in young adults. Green~     tea Epigallocatechin -3-gallate (EGCG) supplementation might favorably influenced many of~     the processes mention in the secondary insult of TBI including neuroinflammation and~     antioxidative damages.~      The investigators aim to investigate whether treatment with Epigallocatechin -3-gallate~     favorably affect outcomes in traumatic brain injury patients. Therefore, in the current~     randomized double-blind clinical trial, 30 patients (15 patients in each group) with~     moderate to severe head trauma admitted to university hospital intensive care unit will~     included. Patients will either receive a daily oral dose of 400 mg EGCG or placebo for 7~     days. The major outcomes includes duration of mechanical ventilation, Glasgow Coma Scale~     (GCS), and S100 protein level.~   "
24883|NCT02731482|"~     This study will investigate the short-and long-term effects of the home-based pulmonary~     rehabilitation on peripheral muscle strength, functional capacity and quality of life in~     patients with bronchiectasis. The participants will be randomized into two groups: control~     group (usual care and recommendations for practice exercise) and training group, that will~     perform aerobic (stepping training) and resistance training (lower and upper limbs) for~     eight weeks, three times a week. At baseline, immediately after finishing and after six~     months the patients will undergo assessments.~   "
24884|NCT02731469|"~     BCD-131 is pegylated darbepoetin beta. BCD-131-1 is open clinical trial to evaluate~     pharmacokinetics, pharmacodynamics, tolerance, safety and immunogenicity of single injection~     of increasing doses of BCD-131 to healthy volunteers compared to Mircera® and Aranesp®.~     Clinical trial will be conducted in two stages. On first stage the optimal dose for~     therapeutic use of BCD-131 will be determined (subcutaneous injections). On second stage the~     determined dose will be injected subcutaneously and intravenously.~   "
24885|NCT02731456|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on psychomotor vigilance to measure~     sustained attention.~   "
24886|NCT02731443|"~     Prospective observational study on epilepsy patients undergoing partial brain resection~     surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and~     3 months and 1 year after surgery using anonymized dream-recall questionnaires. A control~     group of epilepsy patients undergoing diagnostic depth electrodes placement will complete~     the same questionnaires pre- and postoperatively to asses the factor 'general anesthesia' as~     a potential confounder.~   "
24887|NCT02731430|"~     this study compares the use of intrathecal morphine, to multimodal analgesic techniques for~     postoperative pain management following laparoscopic bariatric surgery.~   "
24888|NCT02731417|"~     There are no set national guidelines for the management of postpartum bladder. There is~     little evidence on the management of postpartum urinary retention and many hospitals have~     implemented their own postpartum bladder care protocols.~      Acupuncture has been implemented as an alternative course of treatment for urinary retention~     with reports of spontaneous restoring of micturition in all of the patients. The~     investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary~     retention.~   "
24889|NCT02731404|"~     Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological~     changes, including increased intra-thoracic and ocular pressure, when combined with standard~     ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse~     cardiovascular effects during laparoscopic cholecystectomy.~      Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial~     pressure) during laparoscopic surgery under PP.~   "
24890|NCT02731391|"~     To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.~   "
24891|NCT02731378|"~     A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority~     study~   "
24892|NCT02731365|"~     The purpose of this clinical study is to allow the investigation of local field potential~     (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP~     biomarkers observed as a function of disease symptoms, medication effect, fluctuations in~     disease, and changes resulting from adjustments from current standard practices of DBS~     programming. The data collected and LFP markers identified will serve as guidelines for~     future stimulation predicted programming.~   "
24893|NCT02731352|"~     The purpose of this study is to assess the efficacy and safety of apatinib in locally~     advanced 131I-refractory/resistant differentiated thyroid cancer~   "
24894|NCT02731339|"~     The aim of this study was to investigate the relationship among sagittal spinal curvatures,~     mobility, and low back pain in women with and without urinary incontinence.~   "
24895|NCT02731326|"~     Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly,~     is a major health problem. The long-term goal of this project is to use a personal, mobile~     heart monitor to help patients better recognize recurrent AF and improve patients' ability~     to better manage their condition. A total of 300 patients with a history of AF will be~     included in the study, with 150 patients receiving an iPhone with the mobile monitoring~     device and educational text messaging and the remaining 150 patients continuing with their~     regular medical care. Each patient will be included in the intervention period for 6 months.~     The rate of recurrent AF and treatments meant to manage AF and other heart conditions will~     be determined for both groups. Patients in both groups will complete a series of~     questionnaires at the start and end of the 6 month study period to look at differences in~     quality of life and knowledge of AF.~   "
24896|NCT02731313|"~     The primary objective is to evaluate the concordance between human epidermal growth factor~     receptor 2 (HER2) status determined by the participating laboratory and by the centralized~     laboratory. HER2 status of samples was tested by the participating laboratories~     (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH]~     methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver~     ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.~   "
24897|NCT02731300|"~     Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high~     pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous~     study of cathodal transcranial direct current stimulation (tDCS) in children with focal~     epilepsy showed significant reduction in epileptiform discharges. The investigator~     hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined~     with pharmacologic treatment will be more effective for reducing seizure frequency in~     participants with LGS than pharmacologic treatment alone.~      Material and Method:~      Study participants were randomized to receive either:~        1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS~          over M1 for 20 min or~        2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic~          discharges were performed before treatment and again immediately post-treatment and 1-,~          2-, 3-, and 4-week follow-up.~   "
24898|NCT02731287|"~     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.~     Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a~     non-selective beta-blocker, is an emerging treatment which has been reported to be effective~     and safe for the treatment of IH, especially for superficial hemangiomas. Investigators~     hypothesize that treatment with topical timolol in the first two months of life, before the~     proliferative phase or in early proliferative phase, may prevent from further growing and~     the need to treat with oral propranolol.~   "
24899|NCT02731274|"~     The main purpose of this study was to investigate if a six months period of physical~     exercise, could improve motor memory consolidation in elderly people on pedal dexterity~   "
24900|NCT02731261|"~     The main purpose of this study was to investigate if a six months period of physical~     exercise could improve motor memory consolidation in elderly people.~   "
24901|NCT02731248|"~     Pulse oximetry screening of newborn infants increases early detection of critical congenital~     heart disease and minimises the risk of circulatory collapse before surgery. This study~     provides an update on the implementation of pulse oximetry screening in Turkey~   "
24902|NCT02731235|"~     In a randomized-controlled study the effect of high-intensity training, 5 days a week at~     home for 12 weeks is tested in patients with lacunar stroke.~   "
24903|NCT02731222|"~     The objective of the present study is to determine the degree of correlation between~     clinical severity of chronic venous insufficiency and prevalence of onychodystrophy. The~     achievement of the study will require previously a synthetic exposition of the two diseases,~     emphasizing those factors affecting the proposed analysis.~   "
24904|NCT02731209|"~     The aim of the investigators work is to describe the urodynamic results in the CKD (chronic~     kidney disease) grade 4 patients and to verify observations that urinary catheter may~     improve kidney function in those patients.~      100 patients with CKD grade 4 will do urodynamic examination.~      All patients will be randomized into two groups / the intervention group that will be~     inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be~     monitored by creatinin values and the investigators will measure the time to dialysis in the~     two groups.~   "
24905|NCT02731196|"~     Low back pain is common, costly and affecting up to 80% of the population with the lumbar~     discectomy being a frequent spinal procedure for disc herniations. Pain & mobility~     impairments persist in patients following microdiscectomy with long term issues of back~     pain. The question remains as to why some patients recover quickly and without lasting~     difficulties while other patients persist with prolonged disability following the same~     surgery. The purpose of this study is to determine how to guide the patient towards full~     function and evaluate the timing to initiate strengthening, neurodynamics and a walking~     exercise program.~   "
24906|NCT02731183|"~     Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with~     life-threatening condition, and it is often related with bacterial overgrowth. Fecal~     microbiota transplantation (FMT) results in restoration of the normal intestinal microbial~     community structure. The investigators planned to observe the eﬃcacy of FMT in the treatment~     of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal~     tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and~     remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and~     gastrointestinal quality-of-life index(GIQLI) were evaluated.~   "
24907|NCT02731170|"~     this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive~     Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.~      In the last years, several evidences highlighted the need of a multidisciplinary and~     intensive approach to achieve good results in early stage of disease.~      Hypothesis is that this approach is effectiveness also in moderate and advanced stages of~     disease~   "
24908|NCT02731157|"~     The objective of this proposal is to test the feasibility of red blood cell (RBC)~     rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit~     of RBC rejuvenation in this population to determine if a larger clinical trial powered to~     definitively characterize the benefits of rejuvenation is warranted.~      This is a small pilot study is to see if restoring important energy molecules (ATP and~     2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution~     (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects~     will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6~     transfusions (over approximately a 6-month period) in a pre-defined order to maximize~     detection of any signal.~   "
24909|NCT02731144|"~     In this pilot randomized prospective controlled trial the investigators intend to compare~     the use of a nutritional therapy based on caloric intake determined by indirect calorimetry~     and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein~     intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of~     protein).~   "
24910|NCT02731131|"~     This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy~     and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination~     with ribavirin in participants with CHD.~   "
24911|NCT02731118|"~     Glaucoma is a complex and chronic eye disease which damages the optic nerve. One of the main~     risk factors for the progression of glaucoma is IOP.~      The aim of the study is to examine if Salovum, an anti-secretory factor (AF), can reduce the~     level of the intraocular pressure (IOP) in the eye of patients affected by glaucoma.~      Anti-secretory factor (AF) is an endogenous protein which controls the transport of water~     and ions across the cell membrane. AF plays an important part in the immune system and has~     an anti-secretory and anti-inflammatory effect.~      The investigators' hypothesis is that Salovum can restore a normal salt-water balance in the~     eye, which in turn would lower the IOP. This would eliminate or reduce the risk of~     subsequent visual impairments/neurological damage.~   "
24912|NCT02731105|"~     Study to compare two gels that are used to treat acne vulgaris. It will be compared the~     tolerability and effectivity following application of two combination topical acne products~     clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide~     2,5% gel (Epiduo® Gel).~   "
24913|NCT02731092|"~     To evaluate the safety and tolerability of three different lactoferrin doses in preterm~     infants~   "
24914|NCT02731079|"~     Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies~     have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the~     investigators are unaware of any studies that compare outcomes between devices from the two~     main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this~     study is to compare intraoperative characteristics, such as time to create sleeve,~     intraoperative bleeding, and time needed to load each cartridge, and post-operative~     characteristics, such as any complication requiring readmission (leak or hemorrhage),~     further surgical intervention, and weight loss, between patients who underwent sleeve~     gastrectomy with Covidien devices and Ethicon devices. Currently the investigators~     predominantly use whatever device is cheaper, but cost should not be the primary decisive~     factor if one device is superior to the other. If one device has better clinical outcomes,~     it should be the preferred device regardless of cost. If neither proves superiority, the~     investigators can justify using cost to determine which device to use in patient care.~   "
24915|NCT02731066|"~     This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800~     feet above sea level) and the information obtained can be used to optimize nutrient content~     specifications for combat rations.~      The objectives are:~        1. Determine whether loss of lean body mass resulting from negative calorie balance over a~          22-d period at high altitude can be prevented by increasing dietary protein intake.~        2. Determine the efficacy of carbohydrate (glucose and fructose) supplementation on~          aerobic exercise performance at sea level, acute exposure to high altitude, and in~          response to 22-d period of negative calorie balance at high altitude.~        3. Determine cognitive function, sleep patterns, and behavioral responses to high altitude~          and underfeeding.~        4. Determine appetite and eating behavior in response to high altitude and sustained~          underfeeding.~        5. Examine the effects of high altitude, negative calorie balance, dietary intake~          manipulations on gut health.~   "
24916|NCT02731053|"~     The purpose of this pilot study is to test the effectiveness of French adaptation of the~     Blues program, a school-based indicated depression prevention intervention. The program will~     be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to~     adolescents with sub-clinical depressive symptoms and compared to a no-intervention~     (Informational Brochure only) control condition, designed to represent the usual~     intervention in these schools.~   "
24917|NCT02731040|"~     The purpose of this study is to determine whether women who have atypical subtrochanteric~     and diaphyseal femoral fractures after treatment with bisphosphonates for osteoporosis, have~     a genetic predisposition to these unusual fractures.~   "
24918|NCT02731027|"~     The purpose of the study is to profile biochemical responses and measure functional recovery~     in parallel, throughout the 1st year after spinal cord injury (SCI), within the same~     participants. These responses and recovery will be evaluated in samples from people who have~     had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year~     after SCI. Specifically, the investigators will test the hypothesis that a subset of~     inflammatory biomarkers correlate inversely with functional recovery. The investigators will~     use these data to build a predictive model of functional recovery after SCI that~     incorporates biomarkers that can be easily quantified in the clinic.~      Total anticipated enrollment will be 100 participants with SCI across three different sites~     (Northwell Health System (NY), The Kessler Institute for Rehabilitation (NJ), University of~     Louisville (KY) and may enroll up to 30 participants without SCI.~   "
24919|NCT02731014|"~     The aim of this trial will be to examine the short and long term effectiveness of dry~     needling on pain, disability, and patient perceived improvements in patients with neck pain~     attending physical therapy. The investigators hypothesize that patients who receive dry~     needling, manual therapy, and exercise will achieve greater reductions in pain and~     disability in the short (4 weeks) and long term (6 and 12 months) compared to those who~     receive sham dry needling, manual therapy, and exercise.~   "
24920|NCT02731001|"~     The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis~     and esophagitis grade II or higher by the use of proton therapy compared to photon~     radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life,~     loco-regional control, survival and late radiation induced side effects.~   "
24921|NCT02730988|"~     Intentional weight loss in obese, older adults remains controversial. Although caloric~     restriction, resulting in significant weight and fat mass loss, ameliorates many clinical~     consequences of obesity, recommendation of intentional weight loss in aging remains~     controversial. Reluctance stems, at least in part, from loss of lean and bone mass known to~     accompany overall weight loss and potential exacerbation of age-related risk of disability~     and fracture. Accordingly, current treatment guidelines call fhttp://google.wfu.edu/or~     weight-loss therapy that minimizes muscle and bone losses for older persons who are obese~     and who have functional impairments or medical complications that can benefit from weight~     loss.~      Amount of dietary protein consumed during caloric restriction may be a key determinant in~     maintaining fat-free mass during weight loss. Adequate dietary protein is essential for~     skeletal muscle anabolism; and, epidemiological evidence in older adults point to a salutary~     effect of protein intake above the current RDA (0.8 g/kg/day) on body composition. Indeed, a~     recent position statement by the PRO-TAGE study group advises consumption of 1.0-1.2 g/kg/d~     in older adults during weight-stable conditions to aid in the maintenance of lean body mass~     and function. Practical achievement of this level of protein intake is often difficult for~     obese, older adults undergoing weight loss, yet may be critical to offset weight~     loss-associated lean mass loss. Preliminary data from our group show a lean mass sparing~     effect of high protein consumption during caloric restriction. In post-menopausal women~     undergoing a 5-month intentional weight loss program, consumption of a high (1.2 g/kg/day)~     versus low (0.6 g/kg/day) protein diet was associated with 50% attenuation (17% vs. 37%) of~     lean mass loss. While promising, results have yet to be translated to functional changes in~     a tightly controlled trial of weight loss in obese, older adults.~      The primary goal of this study is to determine whether adherence to a high protein (≥1.0~     g/kg/d) weight loss program results in improved physical function by favorably affecting~     body composition compared to weight stability in obese, older adults. This will be~     accomplished by conducting a 24-week trial in 124 obese (BMI 30-40 kg/m2), older (65-79~     years) men and women, at risk for mobility disability, randomized to either: (1) high~     protein intake (≥1.0 g/kg/d; n=62) during weight loss, or (2) weight-stable control (n=62).~   "
24922|NCT02730975|"~     ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the~     pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in~     fasting conditions at conventional doses, in castration resistant prostate cancer (mCRPC)~     patients who have progressed to docetaxel.~   "
24923|NCT02730962|"~     The purpose of this study is to determine whether changing the microbial composition in the~     colon can improve metabolism of sugar in people who are on the verge of developing diabetes~     (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT)~     using material from lean donors, as well as a series of tests prior to and after the~     transplant. The investigators will examine any changes in fecal bacterial composition~     associated with FMT and determine if any observed changes have an influence on blood sugar~     metabolism.~   "
24924|NCT02730949|"~     The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral~     supplementation in addiction to folic acid compared to folic acid alone on glycaemic control~     as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin~     therapy.~      A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged~     17-50 years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as~     outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome~   "
24925|NCT02730936|"~     This prospective early feasibility clinical study will collect information regarding the~     safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue~     during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e.,~     Class II and Class III) surgical fields.~   "
24926|NCT02730923|"~     The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined~     with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an~     interesting therapeutic option for endometrial cancer with a manageable toxicity profile.~      The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial~     to evaluate the safety and efficacy of a combination treatment associating anastrozole to~     AZD2014 in advanced endometrial cancer patients.~      The study is divided in 2 steps :~        -  A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014~          + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled~          (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of~          product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014~          will be applied in case of toxicity.~        -  A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the~          AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).~   "
24927|NCT02730910|"~     This study will determine the bioavailability of anthocyanins and phenolic compounds from~     two purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and~     bran-enriched wholegrain purple wheat granola bars. Crackers are an example of a baked/~     processed product. The purple wheat granola bars are an example of a food product that~     requires much less intensive preparation and cooking, compared to the crackers. A comparison~     of bioavailability between these two products should provide insights about how different~     processes and food matrix influence anthocyanin bioavailability and metabolism.~   "
24928|NCT02730897|"~     Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS)~     compared to open surgery in patients with cStage-I NSCLC . This finding questions the~     oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar~     and intrapulmonary lymh node dissection. However, these retrospective studies did not~     include analysis of central tumor location, although central tumors have a reported higher~     chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select~     central lesions deliberately for open surgery in line with initial VATS feasibility reports~   "
24929|NCT02730884|"~     The goal of this clinical research study is to learn if rigosertib can help to control MF in~     patients with anemia. The safety of this drug will also be studied.~   "
24930|NCT02730871|"~     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering~     effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added~     to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular~     hypertension.~   "
24931|NCT02730858|"~     The purpose of this research study is to test a new way to deliver oncology and palliative~     care for patients with metastatic breast cancer.~        -  The goal of this study is to test a model where oncology and palliative care work~          together to care for participants with metastatic breast cancer who were recently~          admitted to the hospital or have new or worsening cancer involving their brain or the~          fluid around the brain or spinal cord.~        -  The investigators are studying whether participants who receive care from both teams~          have better communication about their care and improved quality of life and mood~          compared to those receiving care from only their oncologists.~      The purpose of this randomized clinical trial is to conduct a randomized trial testing the~     impact of the collaborative palliative and oncology care model or standard oncology care~     models among patients with poor prognosis metastatic breast cancer. Participants assigned to~     the intervention arm will participate in a series of structured palliative care visits,~     following tailored clinical practice guidelines previously developed for patients with~     metastatic breast cancer.~   "
24932|NCT02730845|"~     The present study will be carried to evaluate the efficacy of intra-articular 0.5~     bupivacaine with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for~     intraoperative anesthesia and postoperative analgesia after arthroscopic knee surgery.~      Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures~     in recent practice which is frequently performed as a day surgery procedures. It can be done~     under general, regional or local anesthesia (LA) with or without sedation. It is associated~     with varying amount of postoperative pain. Postoperative pain negatively influences~     patient's early ambulation, rehabilitation and psychology which consecutively prolonged the~     hospital stay.~      Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented~     procedure that offers many advantages over other anesthesia types. Many anesthesiologists~     are still trying to improve the technique of local anesthetic administration through using~     many combinations with LA solutions in order to administer safe anesthesia to those patients~     and to obtain a pain-free knee with good operating conditions.~      Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative,~     anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing~     effects. It becomes an attractive alternative to the current opioids because it does not~     have a respiratory depressant or addictive effect.~   "
24933|NCT02730832|"~     Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no~     scales to evaluate the oral health of patients with schizophrenia. The only scales that do~     exist are for the population at large, children or the elderly. Given the severely~     deteriorated oral health in these schizophrenic populations, it is important to have a tool~     to evaluate their perception of the quality of their oral health so as to better orientate~     prevention programmes.~      The aim of this study is to validate a tool to measure the perception of oral health in~     patients with schizophrenia.~      To do this, patients will be invited to complete a series of self-questionnaires relative to~     the concept of oral health.~   "
24934|NCT02730819|"~     The purpose of this research study is to gather information on the effectiveness and~     tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA)~     approved topical medications for the treatment of moderate to severe melasma.~   "
24935|NCT02730806|"~     The purpose of this interventional study is to evaluate the effectiveness of the NLP PTSD~     protocol in the event of PPPTSD in comparison with the common practice protocol. The study's~     main hypothesis is that the implementation of both protocols will be equally effective and~     result in reduction of the overall PTSD level.~   "
24936|NCT02730793|"~     This study is designed as a masked, two center, randomized, placebo-controlled pilot study~     to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in~     subjects with CF and lung infection due to PA. The study will involve two sites: Virginia~     Commonwealth University Medical Center (VCU) and Eastern Virginia Medical School (EVMS).~     Potential subjects will be identified in each site's CF clinic.~   "
24937|NCT02730780|"~     This study aims to assess the natriuretic peptide response to dietary salt loading in~     African-American individuals compared with white individuals.~   "
24938|NCT02730767|"~     Exercise can play a major role to mitigate or even prevent late effects in cancer survivors,~     such as cardiovascular disease, obesity, osteoporosis, fatigue, depression, reduced quality~     of life, mental health and physical performance.~      The objective of this study is to assess the effect of an exercise program of 1 year on~     cardiovascular health, obesity and diabetes, osteoporosis, physical fitness, mental health~     and quality of life in childhood cancer survivors. The investigators will recruit childhood~     cancer survivors aged 16 years and above from three Swiss paediatric oncology clinics and~     randomize them into an intervention and a control group. The intervention group will be~     asked to increase physical activity for 1 year by at least 2.5 hours of intense physical~     activity weekly. Regular feedback will be given via a step counter, an online activity~     diary, and by the centre staff. The control group participants will keep their activity~     level constant. All participants will be seen after 3, 6 and 12 months to assess health and~     quality of life parameters over one year. After 1 year, the control group is offered to~     receive the same intervention to profit as well from an active lifestyle.~      If the program shows to be effective, a complete package will become available to interested~     centres treating paediatric cancer patients in Switzerland to promote exercise in all~     survivors. The program will allow clinicians without previous experience in exercise~     counselling to improve the care of their patients.~   "
24939|NCT02730754|"~     This study aims to determine which factors are related to change in diabetes-related~     distress and change in depressive symptoms after three years of follow-up in Asian adults~     with type 2 diabetes mellitus in primary care. The investigators will explore the impact of~     patient demographics, cardiometabolic control, medications adherence, health-related quality~     of life, self-efficacy and self-management behaviors on diabetes-related distress and~     depressive symptoms.~   "
24971|NCT02730338|"~     A Study to determine if high intensity aerobic and resistance training plus psychosocial~     support increases overall survival compared to psychosocial support alone in patients with~     metastatic castrate-resistant prostate cancer.~   "
25438|NCT02724202|"~     The purpose of this study is to test the safety and find the response rate of combining the~     dietary supplement, curcumin, with the standard of care, FDA-approved chemotherapy drug~     5-fluorouracil (5FU, Adracil) and see what effects (good and bad) that the combined~     treatments have on colon cancer.~   "
24940|NCT02730741|"~     The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a~     change in gut flora might be responsible for this intestinal disorder. The effect of~     metformin on the gut flora has been extensively described. It has been shown that the~     therapeutic effect of metformin depends on the microbiota. In agreement with these data, a~     recent publication has shown that metformin's main site of action in humans was the~     intestine. In light of these results, it now seems plausible that metformin's effect on the~     gut flora is responsible not only for its therapeutic effect but also for its undesirable~     digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal~     effects (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused~     dysbiosis and post-antibiotic dysbiosis.~      Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced~     diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that~     Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.~   "
24941|NCT02730728|"~     The purpose of this study is to compare a single shot block, 24 hours, and 48 hour~     continuous catheter nerve block done via the adductor canal method in adult patients who~     have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to~     up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post~     operatively will be used for comparison.~   "
24942|NCT02730715|"~     This study aims to study the effects that two standard of care immunosuppression induction~     regimens have on regulatory T cells (Treg) in live donor renal transplant recipients. Both~     regimens are currently used in this hospital for early immunosuppression induction but the~     effects on Treg numbers and function is not well understood and likely will impact long term~     immune function.~   "
24943|NCT02730702|"~     This is a study whose focus is on understanding the clinical utility of rectal~     ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced~     Backscattering Spectroscopy (LEBS).~   "
24944|NCT02730689|"~     The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg~     and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered~     alone in health male volunteers.~   "
24945|NCT02730676|"~     This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic~     cigarettes following a 12-hour tobacco and nicotine abstinence. The PK results of this study~     will be compared to historical data on smokers obtained in prior studies, as well as on~     naïve and short-term users of electronic cigarettes.~   "
24946|NCT02730663|"~     The purpose of this study is to evaluate the safety and effectiveness of endoscopic~     ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment~     of pancreatic pseudocyst.~   "
24947|NCT02730650|"~     This study will be a prospective study of patients who undergo platelet-rich therapy (PRT)~     for facial rejuvenation at NYU Langone Medical Center. PRT has been increasingly used for~     wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves~     injection of patient's own platelets and fibrin, and has evolved as a less invasive~     technique for facial rejuvenation compared to more traditional techniques. Through the use~     of pre and post treatment photos, in addition to the FACE-Q Questionnaire and a clinician~     assessment, it is our hope that we will confirm the rejuvenating capabilities of PRT.~   "
24948|NCT02730637|"~     This study examines the clinical relevance of early biomarkers to detect and prevent acute~     kidney injury. High-risk patients for developing acute kidney injury will be screened at~     initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In~     case of elevated readings patients will be randomized in two arms: The control group will be~     treated with standard care, the intervention group will receive an early nephrologic~     consultation.~   "
24949|NCT02730624|"~     This is prospective study to assess the pharmacodynamics (t>MIC) of 4.5 g every 6 h of~     piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following~     administration by a 30 min infusion.~      Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs,~     APACHAE II score, BUN, Cr and fluid balance will be collected.~      Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be~     carried out during the piperacillin/tazobactam therapy.~      Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe~     sepsis or septic shock, blood samples (approximately 3 ml) will be obtained by direct~     venipuncture at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after~     piperacillin/tazobactam therapy.~      Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get~     PK/PD index and reported to % PTA and % CFR.~   "
24950|NCT02730611|"~     Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract~     cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle~     factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation~     and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in~     the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some~     elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve~     gastrectomy may change bile acid composition.~      The aims of this study are:~        1. whether specific presurgical bila acid profiles are predictive of efficacy of vertical~          sleeve gastrectomy, reflective of liver function and metabolic dysfunction;~        2. whether specific presurgical bile acid profiles are predictive of the efficacy of~          sleeve gastrectomy~   "
24972|NCT02730325|"~     The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated~     and compared to matching placebo in two distinct patient populations:~      I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium~     difficile (C. difficile) at time of admission and are receiving vancomycin.~      II. Hospitalized UC patients who tested negative for C. difficile at time of admission.~   "
24973|NCT02730312|"~     The purpose of this study is to determine the safety and tolerability of weekly intravenous~     (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after~     the first dose, and then to determine the MTD after second and subsequent infusions.~   "
24974|NCT02730299|"~     This study is an open-label, controlled, multicenter, international, Phase III, randomized~     study of transplantation of NiCord® versus transplantation of one or two unmanipulated,~     unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid~     leukemia, myelodysplastic syndrome or chronic myeloid leukemia, all with required disease~     features rendering them eligible for allogeneic transplantation.~   "
24951|NCT02730598|"~     Osteoarthritis of the knee (KOA) is the most common cause of disability in older adults.~     Osteoarthritis involves a loss of cartilage, which acts like a cushion between the bones as~     well as changes in the bones of joints. Once the joint cartilage is gone, the body does not~     produce new cartilage. Joint damage can contribute to pain. Currently, treatment for pain~     associated with knee osteoarthritis includes exercise. However, exercise at a medium- to~     high-intensity level can be problematic for people with knee pain. Because exercise is a~     common treatment for knee pain but many people experience pain during exercise, researchers~     hope to find a safer and more effective exercise method to strengthen the muscles around the~     knee.~      Both aerobic exercise and resistance exercise are recommended for the treatment of people~     with knee pain. However, pain can be a barrier to participating in exercise at a moderate or~     vigorous intensity. Electrical stimulation of muscles holds potential to allow effective~     exercise to be completed at tolerable intensities. Transcutaneous electrical nerve~     stimulation (TENS) is the use of very low electric currents produced by a device to~     stimulate the nerves, to treat pain. Neuromuscular electrical stimulation (NMES) uses low~     electrical current to cause muscles to contract.~      By doing this study, the investigators hope to learn if a hybrid training system (HTS),~     using a combination of NMES and walking, is effective in strengthening muscles in people~     with knee pain, aching or stiffness.~      In this pilot study, the investigators will use walking with TENS as conventional exercise.~      Randomized controlled trial will be conducted to compare the effect of walking augmented by~     HTS with walking without HTS. The investigators will evaluate the relative advantages of~     training that combines HTS with conventional walking exercise on the improvement of muscle~     strength, physical function, and pain relief in obese women with frequent knee symptoms.~      Study Hypotheses: Compared with walking with sensory TENS, walking with HTS will:~        -  1 increase quadriceps muscle strength.~        -  2 decrease knee pain.~      Exploratory Hypotheses:~        -  3 improve physical function.~        -  4 increase PPT (improve central sensitization).~        -  5 improve self-reported quality of life.~   "
24952|NCT02730585|"~     The diagnosis of acute appendicitis is difficult and despite important advances in medical~     sciences, detailed patient questioning and precise medical examination are the main~     keystones of the diagnosis of acute appendicitis and up to now, results still~     unsatisfactory.~   "
24953|NCT02730572|"~     The primary purpose of this study is to identify whether, after adjustment for confounders~     via stratification on a propensity score and adjustment for calendar year, the combined~     endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of~     immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity~     disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA]~     methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG]~     methylphenidate} that was begun on the index date), differs between participants who switch~     from branded Concerta to the EG formulations versus participants who switch from branded~     Concerta to the AG formulation.~   "
24954|NCT02730559|"~     The primary focus of this proposal is to address growing concern of overweight/ obese~     adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled~     clinical trial to compare the effectiveness of Motivational interviewing (MI) interventions~     with the parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be~     recruited from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad~     will have more success due to the possible synergetic effect compared to adolescents alone.~     The study's primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary~     outcomes include overall improvement in their lifestyle and their responses to the MI~     intervention.~   "
24955|NCT02730546|"~     This phase Ib/II trial studies the side effects and best way to give pembrolizumab with~     combination chemotherapy and radiation therapy before surgery and to see how well it works~     in treating adult patients with gastroesophageal junction or gastric cardia cancer that has~     spread from where it started to nearby tissue and can be removed by surgery. Monoclonal~     antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting~     certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving pembrolizumab, combination chemotherapy, and radiation therapy before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
24956|NCT02730533|"~     This will be a single-centre, randomised, endoscopist-blind, parallel-group study in~     patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal~     lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole~     premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to~     gastric mucosal lesions.~   "
24957|NCT02730520|"~     Worldwide, respiratory diseases have a significant impact on morbidity and mortality of~     individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important~     role in the prevalence and morbidity of these diseases. Scientific literature indicates that~     sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive~     pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen~     sensitivity.~      To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One~     of the methods used is the technique of prick test. In practice, a drop of purified~     allergen extract is placed on the patient's skin (arms or back). A little dosis of the~     product is then injected in the epidermis. If fifteen minutes later, there is an edematous~     reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the~     patient is sensitized to the tested foods or allergens.This technique is painless and~     convenient to patients of all ages, including newborns or conversely very aged patients.~      This is a retrospective study based on the encoding and statistical analysis of data~     collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann~     Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The~     allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae~     (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive~     tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.~      At least 1400 files will be analyzed.~      Patients will be distributed in six age groups.The results of the allergen skin tests will~     be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for~     each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI~     and residential area on the allergic reactivity will also be assessed in the overall~     population and within each age group.~      The main objective is to evaluate the effect of age on the skin test positivity. The~     secondary objective is to highlight the environmental factors that have an impact on~     allergic diseases.~   "
24975|NCT02730286|"~     Objective: To evaluate what factors contribute to activity limitations in subjects with~     rheumatoid arthritis considering the International Classification of Functioning, Disability~     and Health model.~      Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using~     instruments to measure five constructs of the component activities.~   "
24991|NCT02730091|"~     This study is designed to evaluate the clinical effects of the addition of metronomic oral~     vinorelbine to letrozole and anastrozole. The study will compare the efficacy and~     tolerability of oral metronomic vinorelbine administered in combination with letrozole or~     anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer~     without resistance to Aromatase Inhibitors (AI).~   "
24992|NCT02730078|"~     The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple~     and short value-based emotion-focused educational programme in adults with type 2 diabetes~     (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication~     adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.~   "
24958|NCT02730507|"~     Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions~     of patients worldwide. LDD can impact not only function, but can also become markedly~     disabling and cause severe chronic pain. Recent studies support the idea that analysis of~     sagittal balance is a crucial keypoint to optimize the management of lumbar degenerative~     diseases, especially when spinal instrumentation is intended.~      The first treatment of these pathologies is a medical treatment (medications, physical~     therapy and exercise). Surgical treatment is frequently necessary if the symptoms worsen and~     is generally a posterior spinal fusion with instrumentation (screws, hooks and rods) and~     bone graft. Basic principle of the surgery is to realign the spine along the rod.~      Despite documented techniques for surgical planning, it appears that a significant number of~     patients are ultimately under-corrected after surgery Realignment failure has not only been~     associated with poor functional outcome but also major complications, such as~     pseudoarthrosis and rod breakage, which often results in additional surgical procedures.~      From a pragmatic point of view, there are two main reasons for realignment failure: poor~     surgical planning and poor execution. One of the assumptions is that perioperative manual~     bending of the rod may not always allow the surgeon to restore the sagittal parameters as~     intended.~      A new concept of patient-specific rod (PSR) is now being proposed by a French manufacturer~     in order to enable an optimal correction and surgical stabilization of the spine. PSR are~     designed to fit with the patient's unique sagittal spine profile and with surgeons' surgical~     planning. However, no relevant clinical data is currently available to support the expected~     medical benefit of this new technology.~      The objective of the study is therefore to carry out a study hypothesizing that the use of~     PSR could improve the percentage of patients whose sagittal profile is optimally corrected~     after spinal surgery, as well as the patient's quality of life.~   "
24959|NCT02730494|"~     The primary objective of this study is to study the vaginal flora colonisation equivalence~     between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0~     (V1) and Dend of treatment.~   "
24960|NCT02730481|"~     This is a multicenter, open-label, safety study. Eligible subjects will be adults with~     advanced malignancies. The study includes a pretreatment and treatment phase. The~     pretreatment phase consists of screening and baseline periods. The treatment phase consists~     of 4-week treatment periods and a follow-up period.~   "
24961|NCT02730468|"~     The purpose of this study is to evaluate the performance of the Karius Infectious Diseases~     Plasma Sequencing Assay in patients who present to the emergency room with sepsis.~   "
24962|NCT02730455|"~     The primary objective of the study is to assess the clinical effects of natalizumab versus~     placebo in acute ischemic stroke on clinical measures of functional independence and~     activities of daily living. The secondary objective of the study is to explore dose and~     exposure response and the clinical treatment effects of natalizumab versus placebo in acute~     ischemic stroke on the following: measures of independence, activities of daily living,~     neurologic function, quality of life, cognition, and safety and tolerability~   "
24963|NCT02730442|"~     This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV~     over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8,~     after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4~     days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo~     the same dosing schedules of fluconazole and F901318 and undergo the same procedures. The~     first cohort will consist of 12 subjects studied in two groups of six subjects each. If~     there is clearly a difference in F901318 kinetics detectable before and after dosing with~     fluconazole in this first cohort, the second cohort will not be studied. If there is no~     clear difference, the second cohort will also be studied to give a final result. In this~     cohort, based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be~     increased to up to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling~     for plasma F901318 will continue from before the first dose up to and including 72 hours~     after dosing. PK sampling for fluconazole will continue from before the first dose and up to~     72 hours after the fifth dose. A follow up visit will be conducted 7 +/- 2 days after~     discharge from the clinical unit following completion of blood sampling following the second~     dose of F901318 and the fifth dose of fluconazole.~      The second part of the study will take place if no appreciable change in the~     pharmacokinetics of either F901318 or fluconazole has been observed in either the first or~     the second cohorts in the first part of the study. This second part will enrol 12 subjects.~     These subjects will receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily~     orally for 4 days (Days 2 to 5) in combination with F901318 which will be given in a dose of~     up to 4 mg/kg IV bid for one day (Day 1) followed by 7 doses of intravenous F901318 up to~     2.5 mg/kg bid (Days 2 to 5). Pharmacokinetic profiles of F901318 and fluconazole will be~     obtained during dosing and over a 72-hour period following the final dose of both compounds.~   "
24964|NCT02730429|"~     This randomized phase 2 trial is evaluating superiority of Letrozole-palbociclib combination~     versus letrozole alone in ER positive endometrioid adenocarcinoma of endometrium~   "
24965|NCT02730416|"~     This study will evaluate the role of addition of an anti-angiogenic agent~     (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance~     treatment in primary advanced or with first relapse of endometrial cancer.~   "
24966|NCT02730403|"~     This is an observational, ancillary study intended to describe opioid use among opioid use~     disorder patients following their discharge into the community from inpatient detoxification~     and/or short-term residential treatment programs affiliated with parent study CTN-0051,~     which assessed the comparative effectiveness of extended release injectable naltrexone~     (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention~     of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high~     affinity partial agonist indicated for maintenance treatment of opioid dependence, as~     pharmacotherapeutic aids to recovery.~   "
24967|NCT02730390|"~     The primary objective of this post marketing surveillance (PMS) is to determine the safety~     and efficacy of probucol in lowering the level of serum cholesterol in the blood.~   "
24968|NCT02730377|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy in~     controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background~     treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in~     subjects with type 2 diabetes.~   "
24969|NCT02730364|"~     The purpose of the study is to assess the short term efficacy of the Theraflu Night powder~     for oral solution in the Russian population in Short term relief of the symptoms of colds,~     chills and influenza, including mild to moderate pain, fever and nasal congestion.~   "
24970|NCT02730351|"~     This is a multicenter, randomized, double-blind, double-dummy, crossover study with two~     2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in~     up to eight study visits and have a follow up phone call approximately a week after the last~     clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM~     and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM~     and continue over a period of approximately 24 hours. Subjects will be required to attend~     three clinic visits during this 24-hour period. An exercise challenge (using a treadmill)~     will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment~     dose in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7.~     Spirometry will be conducted at specified visits and prior to and after each exercise~     challenge.~      Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to~     four weeks with intranasal corticosteroids followed by a repeat screening visit to determine~     eligibility prior to entry into the study.~      Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram~     (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized~     treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind~     Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately~     7-days after completing Treatment Period 2. The total duration of study participation is~     approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis.~      The primary objective of the study is to evaluate the protective effect of fluticasone~     furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP)~     250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult~     subjects aged 12 to 50 with persistent asthma.~      ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of~     companies.~   "
24976|NCT02729233|"~     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). UC is an~     ongoing disease of the colon or large intestine. Studies have shown that leakiness of the~     gut plays a major role in the development of UC. Leakiness of the gut is a condition that is~     a result of damage to the intestinal lining, making it less able to protect its internal~     environment as well as to filter needed nutrients and other substances. Some bacteria,~     toxins, and waste not normally absorbed may get into the blood stream.~      Golimumab is an FDA approved medication used for the treatment of moderate to severe~     ulcerative colitis. The investigators have evidence to suggest that measuring the leakiness~     of the gut using a tool called a confocal laser endomicroscope may be able to predict how~     well a patient's body will respond to treatment of UC with golimumab. Confocal laser~     endomicroscopy (CLE) is an FDA approved technique that can look at the cells of a patient's~     gut during colonoscopy to assess the leakiness of gut.~      The objective of this study is to determine how the leakiness of the gut in patients with UC~     can predict response to golimumab therapy.~   "
24977|NCT02729220|"~     The purpose of this study is to find out if subjects with chronic obstructive pulmonary~     disease have signs of accelerated ageing in their airways.~   "
24978|NCT02730260|"~     Social support is poorly understood but likely to influence outcomes of behavior change~     efforts. Social support may take a directive or nondirective approach. In directive support,~     the person attempting a behavior change is told what to do and even what to think. In~     nondirective support, the person attempting the behavior change decides what to discuss. In~     some contexts, interactions of race or income with social support have been reported. This~     is a randomized controlled trial of directive and nondirective coaching in the context of a~     smoking quitline offered to employees of two large corporations.~   "
24979|NCT02730247|"~     The subjects who take part in this clinical research study have advanced non-small cell lung~     cancer (NSCLC) that has been previously treated with other drugs. If they join this study,~     they would receive ramucirumab (Cyramza ®) in combination with nab-paclitaxel (Abraxane®).~     Ramucirumab given with nab-paclitaxel is considered an investigational drug combination to~     use in this type of cancer because giving these two drugs together has not been approved by~     any regulatory authority like the US Food and Drug Administration (FDA) for NSCLC cancer.~     Ramucirumab works by slowing or stopping the growth of cancer cells. Nab-Paclitaxel works by~     blocking the ability of cancer cells to break down the internal 'skeleton' that allows them~     to divide and multiply. With the skeleton still in place, the cells cannot divide and they~     eventually die.~   "
24980|NCT02730234|"~     The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and~     adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization~     (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment~     of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.~      This is a prospective, multicenter, single arm study evaluating the investigational use of~     Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of~     FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category~     (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old~     balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the~     field.~   "
24981|NCT02730221|"~     A prospective observational study in the Intensive Care Unit and the Medium Care Unit in a~     university hospital in Amsterdam. Recent studies show that administrative tasks occupy more~     than 30% of the workload. One-third of these administrative tasks is unrelated to care. The~     administrative workload of physicians and nurses will be observed and quantified using two~     different methods. The amount of time physicians and nurses are logged on into the patient~     data management system (PDMS) will be measured and the time spent on different work tasks~     will be monitored with a work sampling method. Two different patient data management systems~     will be compared.~   "
24982|NCT02730208|"~     The primary purpose of study is to evaluate the treatment effect of VX-661 in combination~     with ivacaftor (VX-661/ivacaftor) on chest imaging endpoints using low-dose computed~     tomography (LDCT) at Week 72, and to evaluate the safety of VX-661/ivacaftor through Week 72~   "
24983|NCT02730195|"~     This phase II trial studies how well pioglitazone hydrochloride and tyrosine kinase~     inhibitor (TKI) therapy works in treating patients with chronic myeloid leukemia (CML) that~     has come back after a period of improvement (relapsed) after a first TKI discontinuation.~     TKI may stop the growth of cancer cells by blocking certain enzymes need for cell growth.~     Although TKI therapies are effective against CML, there are residual cancer cells called~     leukemia stem cells that are able to hide from TKIs. Pioglitazone hydrochloride is a drug~     approved by the Food and Drug Administration to treat diabetes and has been shown in~     laboratory studies to increase CML stem cell death when given together with TKI therapy.~     Giving pioglitazone hydrochloride with TKI therapy may be effective in treating patients~     with CML.~   "
24984|NCT02730182|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on postural control~   "
24985|NCT02730169|"~     The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese~     subjects with hypogonadotrophic hypogonadism. All subjects will be treated for a maximum of~     24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in~     a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll~     268 subjects.~   "
24986|NCT02730156|"~     Prospective interventional trial in lowlanders evaluating effect of acute exposure,~     acclimatization and re-exposure to high altitude~   "
24987|NCT02730143|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure of high altitude on nocturnal breathing pattern.~   "
24988|NCT02730130|"~     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on~     the patient and areas of cancer in their body that did not receive radiation therapy.~   "
24989|NCT02730117|"~     Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in~     Critically Ill Patients with Acute Kidney Injury with Positive Furosemide Stress Test?: a~     Multicenter Randomized Controlled Trial~   "
25524|NCT02723084|"~     The purpose of this study is to evaluate the efficacy and safety of 8 weeks of treatment~     with the combination regimen ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for~     12 weeks in Hepatitis C Virus Genotype 2 (GT2) infected participants.~   "
24993|NCT02730065|"~     Introduction: Cerebral small vessel disease (SVD) is associated with age-related~     disabilities including dementia, depression, physical and functional impairment. Chinese are~     more prone to developing SVD than Caucasians. Physical exercise may improve multiple~     negative consequences associated with SVD.~      Objective and hypothesis to be tested: To examine the effects of a 24-week structured~     aerobic dance training on cognition, mood, physical and daily functions in stroke and~     dementia free older adults with SVD, and whether such effects are mediated through improved~     cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired~     in SVD.~      Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic~     dance training upon cognition, mood, physical and daily functions on 110 community dwelling,~     stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as~     the presence of multiple (≥2) lacunes and/or early confluent or confluent WML.~      Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured~     therapist-led group aerobic dance training with home practice or simple stretching plus~     health education control group.~      Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using~     Transcranial Doppler at baseline, weeks 12, 24 and 36.~      Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed~     using mixed effects models. Mediation effects of CVR between aerobic dance training and~     treatment outcomes tested using mediation models.~      Expected results: In persons with significant SVD, aerobic dance training improves~     cognitive, mood, physical and daily functions and such effects are mediated by changes in~     CVR.~   "
24994|NCT02730052|"~     The proportion of hypertensive patients achieving adequate blood pressure control meeting~     guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50%~     reach control.~      Objectives:~        1. Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive~          patients.~        2. Investigate whether telemonitoring enabled self-measurement of blood pressure leads to~          faster blood pressure control than self-measurement without telemonitoring.~        3. Secondary endpoints include adverse effects, assessment of quality of life, adherence,~          a log of technical problems, and cost-effectiveness.~      Methods:~      Randomised parallel-group study consisting of 4 stages.~        -  Screening to check for eligibility.~        -  Randomisation in a 1:1 proportion to control or experimental arm: In the control arm,~          doctors will receive reports on the self-measured blood pressure based on diary cards;~          in the experimental group, doctors will receive weekly reports via telemonitoring.~        -  Treatment period: Doctors will adjust treatment according to the present guidelines of~          Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic~          and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period~          ends.~        -  Late follow-up: Assessment of blood pressure control at home 3 months after completion~          of the treatment period by means of telemonitoring.~      Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and~     Argentina.~      Main Inclusion Criteria:~        -  Women and men, age range 20 to 80 years.~        -  Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood~          pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;~        -  Patients should be willing to accept adherence checking during follow-up and sign an~          informed written consent.~      Exclusion Criteria~        -  Patients emotionally or intellectually not capable of measuring their blood pressure at~          home;~        -  A clinical or social context, which is suboptimal for the self-measurement of blood~          pressure;~        -  Pregnancy;~        -  Alcohol or substance abuse or psychiatric illnesses;~        -  Participation in another study. Expected outcomes: blood pressure control will be~          achieved faster in the telemonitoring group.~   "
24995|NCT02730039|"~     The purpose of this project, entitled Meaning-Centered Psychotherapy Training for Cancer~     Care Providers, is to develop a multi-modal training program in Meaning-Centered~     Psychotherapy (MCP) for multidisciplinary cancer care clinicians who provide psycho-oncology~     and psychosocial palliative care services for cancer patients.~   "
24996|NCT02730026|"~     The control of pain, swelling and trismus in patients undergoing oral and maxillofacial~     surgery is frequently performed through the administration of non-steroidal~     anti-inflammatory drugs (NSAIDS). The present study aims to evaluate in a double blind,~     randomized and crossover manner the clinical efficacy of ketoprofen (immediate release - 100~     mg) and ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with~     20 mg omeprazole) in 50 patients aged 18 years or older that require removal of both lower~     third molars symmetrically positioned. After collection, data will be analyzed by means of~     graphs and tables to allow the appropriate analyses. Paired t-test will be used to compare~     the duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of~     rescue medication and postoperative pain parameters (visual analog scale). Data of mouth~     opening and swelling will be statistically analyzed through analysis of variance (ANOVA)~     followed by Tukey's test for multiple comparisons. Statistical significance will be set at~     5%. Results will be presented as mean ± standard deviation of the mean.~   "
24997|NCT02730013|"~     This is a 3 month cluster randomized controlled trial using a square-stepping exercise~     program (a.k.a. mind-motor exercise) in retirement and long-term care residences to improve~     global cognitive functioning in older adults with and without cognitive impairments. The~     investigators intend this project to be pragmatic and therefore will include residents with~     dementia and walking aids if the participants wish to participate. The primary outcome is~     global cognitive functioning, secondary outcomes include: single and dual task gait (only~     completed with those without dementia), oculomotor functioning, and functional fitness. The~     investigators hypothesize that there will be improvements in primary and secondary outcomes~     in the intervention group.~   "
24998|NCT02730000|"~     Given the clinical damage caused by errors commonly made during the dosage and handling of~     glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated~     ionomer has been recommended for final restorations. However, the initial cost of the~     encapsulated MIC is higher when compared to the material handled manually. The objective of~     this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV~     Riva Self Cure and Equia used as a restorative material in atraumatic restorations~     (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and~     occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated~     IC, (3) assess whether the child's caries experience influences the longevity of atraumatic~     restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP~     municipality. Randomization will be performed in a stratified manner by the conditions: type~     of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV -~     Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and~     18 months by two trained examiners blind to the groups (intra- and inter-rater agreement~     above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival~     analysis and log-rank test. To evaluate the association between longevity and variable Cox~     regression test will be applied. For the cost analysis will be used analysis of variance.~   "
25525|NCT02723071|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy~     of ocrelizumab in participants with progressive follicular NHL.~   "
25526|NCT02723058|"~     The purpose of this study is to pilot test an adapted collaborative care model for homeless~     mothers with depression.~   "
24999|NCT02729987|"~     The purpose of this pilot study is to explore the effect of an online facilitated discussion~     group on engagement with a stress management intervention delivered to employees in the UK~     via the Internet. The investigators primary hypothesis is that the intervention group with~     access to an online facilitated discussion group (delivered via a message board) will show~     greater engagement than the intervention group that does not have access to the discussion~     group. The investigators also hypothesise that participants in the intervention groups will~     improve significantly on psychological distress and subjective wellbeing measures compared~     to the waiting list control group, and that the group with access to the online facilitated~     discussion group will show the greatest improvement.~   "
25000|NCT02729974|"~     This study evaluates the use of rapid tests for hematocrit and clotting function in women~     undergoing surgery for placenta accreta. Half of participants will have these rapid tests~     performed during surgery to guide blood product transfusion and the other half will have~     standard lab tests performed to guide transfusion.~   "
25001|NCT02729961|"~     This phase I/II trial studies the side effects and best dose of ceritinib when given~     together with brentuximab vedotin to see how well they work in treating treatment-naive~     patients with anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma.~     Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability~     of tumor cells to grow and spread. Giving ceritinib together with brentuximab vedotin may be~     a better treatment for ALK-positive anaplastic large cell lymphoma.~   "
25002|NCT02729948|"~     This pilot clinical trial studies how well tethered capsule endoscope works in screening~     patients with Barrett esophagus (BE), a condition where the lining of the esophagus has~     changed or has been replaced with abnormal cells that may lead to cancer also called~     esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer,~     patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients~     are sedated and the doctor uses an endoscope to examine the tissue in the esophagus.~     Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord~     attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific~     area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is~     removed using the thin cord. Tethered capsule endoscope may be able to identify tissue~     changes in patients with BE without the need for sedation or anesthesia, thus eliminating~     the associated risks and costs associated with EGD.~   "
25003|NCT02729935|"~     Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in~     the supra-pubic region; reported postoperatively in patients who have had urinary~     catheterization intra-operatively. In the present study, the investigators evaluated~     Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral~     resection of bladder tumor (TURBT).~   "
25004|NCT02729922|"~     CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the~     pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to~     help management of selected heart failure patients. Heart failure patients with NYHA class~     III heart failure, irrespective of the left ventricular ejection fraction, and a previous~     hospital admission for heart failure in the past 12 months, without stage IV or V chronic~     kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a~     registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily~     heart failure hospitalizations, heart failure related quality of life and re-admissions.~   "
25005|NCT02729909|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of~     24 ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
25006|NCT02729896|"~     This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of~     obinutuzumab (G) + atezolizumab (Atezo) + polatuzumab vedotin (Pola) in participants with~     relapsed or refractory FL or DLBCL. The study will include an initial dose-escalation phase~     designed to determine the recommended Phase 2 dose (RP2D) for polatuzumab vedotin in this~     treatment combination, followed by an expansion phase in which polatuzumab vedotin will be~     given at the RP2D. All participants will receive induction treatment with G + Atezo + Pola~     for 6 cycles. FL participants achieving a complete response (CR), partial response (PR), or~     stable disease (SD) at the end of induction (EOI) and DLBCL participants achieving a CR or~     PR at EOI will be eligible to receive post-induction treatment with obinutuzumab +~     atezolizumab.~   "
25007|NCT02729883|"~     This pilot clinical trial studies Take the Fight in supporting and empowering patients with~     cancer through their treatment process. Patients with cancer are faced with many obstacles~     created by the current state of the healthcare system. The purpose of Take the Fight is to~     train college students, also called patients' navigators or strategists, to assist and~     support patients to navigate into the healthcare system and receive the care they need. The~     strategists are matched with patients and attend/coordinate most patients' medical~     appointments. The strategists also advance communications between the patient and the~     medical staff to facilitate both the exchange of medical information as well as increase the~     patient's compliance with treatment. Take the Fight may improve the health and quality of~     life outcomes of cancer patients during critical treatment periods by increasing treatment~     compliance, eliminating barriers to better care, and increasing clinical trial~     participation.~   "
25008|NCT02729870|"~     Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The~     investigators investigate oral glucose gel for its effectiveness in rapidly reducing~     ketoacidosis and for improvements in oral hydration therapy success.~   "
25009|NCT02729857|"~     The aim of the study is to understand more about how different fatty acids modulate~     postprandial lipid metabolism and inflammatory response.~   "
25065|NCT02729103|"~     This study will evaluate treatment patterns, mortality, healthcare resource utilization, and~     costs in patients with prostate cancer with bone metastases (primary objectives).~     Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this~     patient population (secondary objective). The study is descriptive in nature and is meant to~     provide a greater understanding of the patterns of therapy observed in real-world clinical~     practice (in the absence of clear guideline recommendations with regards to treatment~     sequencing), to contribute to a greater understanding of the major cost drivers (thus~     better-informing payers), and to examine real-world mortality in such patients.~   "
25010|NCT02729844|"~     NeoLifeS is a cohort follow up study that prospectively collects data of regular care of~     children born preterm in the University Medical Center Groningen (UMCG) and aims to improve~     the quality of care for these children.~      NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm~     infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm~     infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the~     vasculature of the lungs is often not fully developed, making them more vulnerable for the~     development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of~     the infants with extremely low birth weight are believed to develop PH, this proportion has~     been suggested to raise to 50% in infants with severe BPD. The presence of PH significantly~     worsens the prognosis and survival of these children.~      The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk~     factors for the development of PH and survival, will be the first step in improving~     detection strategies, possible treatment options and thereby prognosis and survival of these~     children.~      Objective: To determine the incidence and prevalence of PH in preterm infants. In addition~     we aim to identify risk factors for the development of PH and determine the survival and~     prognosis of these preterm infants.~      Study design: A prospective cohort study. Study population: All preterm infants, admitted at~     the neonatology UMCG, born <30 weeks and/or birth weight < 1000 gram, who participate in~     NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence).~      Secondary parameters:~        -  Maternal and neonatal patient characteristics that are potential risk factors for the~          development of PH,~        -  Morbidity-score (quality of life and hospital admissions) and mortality.~   "
25011|NCT02729831|"~     This study is a 2X2 factorial randomized trial that will the examine the comparative~     effectiveness of two patient decision aids for hip and knee osteoarthritis as well as the~     impact of a surgeon-focused intervention.~   "
25012|NCT02729818|"~     Microperimetry is a relatively new and extremely sensitive method of assessing visual~     function. It projects light stimuli onto a defined area of the retina to map retinal~     perceptual thresholds. Participants look at a focal point and press a button to indicate~     when they have seen a light stimulus. The stimuli vary in intensity to find the~     participant's visual sensitivity.~      Microperimetry is carried out in low light conditions. Before testing, participants must~     adapt to the low light conditions in a process called 'dark adaptation.' Currently there is~     no consensus on the optimal time needed for dark adaptation. Investigators know that visual~     sensitivity differs in differing light conditions. Failing to sufficiently dark-adapt may~     therefore adversely affect test results.~      The aim of this study is to establish the optimal length of dark adaptation for~     microperimetry performance in healthy volunteers. On day 1, participants will undergo~     training field tests to reduce a learning effect affecting the results. Tests will then be~     performed following 5 mins adaptation, 10 mins adaptation and 30mins adaptation, On day 2,~     participants will perform testing following no adaptation time, 15 mins adaptation, and 20~     mins adaptation. Statistics will be used to determine the effect of adaptation time on~     average threshold measures.~   "
25013|NCT02729805|"~     Preventive analgesia is when an administered analgesic drug provides reduction in pain~     beyond its duration of action. This can be used to reduce acute postoperative pain and~     prevent occurrence of chronic post-surgical pain.~      According to the International Association for the Study of Pain (IASP), chronic pain can be~     defined as pain that persisted beyond the time of normal tissue healing (usually 3 months)~     and that was not related to other causes. Mastectomy is associated with a high incidence of~     chronic post-surgical pain. Breast cancer is the most common malignancy affecting females~     around the world. Many undergo mastectomy as part of curative treatment. However, a~     significant proportion of patients experience chronic post-surgical pain. This results in~     significant negative impact on physical, psychological and social wellbeing.~      Ketamine is an intravenous anaesthetic drug with analgesic effects. It can be used to treat~     both acute and chronic pain. A recent meta-analysis of different surgeries showed that~     patients receiving ketamine had a modest but statistically significant reduction in~     incidence of chronic post-surgical pain. In a small sample single dose pilot study, patients~     given low dose intravenous ketamine intraoperatively had a statistically non-significant~     reduction in incidence of pain around the surgical scar at three months after radical~     mastectomy. Randomized control trials with larger sample sizes are needed to determine the~     effectiveness and optimal dosing regime of ketamine for reduction of chronic post-mastectomy~     pain. It is therefore hypothesized that intravenous ketamine given intraoperatively will~     reduce the incidence and severity of chronic pain after modified radical mastectomy. A~     double blind randomized controlled trial comparing placebo group with two different doses of~     ketamine is proposed.~      The mechanism of action of ketamine in reducing pain is complex and multiple. How ketamine~     can prevent and reduce chronic pain is unknown. Ketamine has been shown to reduce immediate~     gene expression at site of mechanical injury. Transient Receptor Potential Vanilloid 1~     (TRPV1) and Transient Receptor Ankyrin 1 (TRPA1) are receptors shown to mediate acute and~     chronic pain. Ketamine, shown to affect gene expression, may alter the expression of TRPV1~     and TRPA1 via epigenetic mechanisms.~   "
25014|NCT02729792|"~     Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically~     refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical~     neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies~     and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral~     prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when~     medications have failed. However, other possible targets may also yield improvement in~     symptoms.~      In an attempt to enhance the therapeutic efficacy of current interventions for TRD,~     attention has turned to identifying domain-specific biomarkers in hopes of ultimately~     individualizing and predicting treatment response. Unfortunately, the precise nature of this~     relationship is less than clear, as reflected by the fact that even now there are no~     established biomarkers that are used routinely in clinical practice to aid in diagnosis.~     This study also seeks to examine a comprehensive suite of biomarker measurements (MRI,~     neurophysiology, and genomics/proteomics) before and after rTMS treatment.~   "
25015|NCT02729779|"~     Chronic low back pain is potentially disabling for the elderly, and physical exercises are~     considered the best treatment for this problem. The Pilates method has been proven effective~     in the improvement of pain and function in patients with low back pain. However, the~     evidence about the effectiveness of Pilates method in the treatment of elderly patients with~     low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of~     the Pilates method compared to aerobic exercise in elderly with chronic non-specific low~     back pain. This randomized controlled trial with two arms and blinded assessor will include~     74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific~     low back pain persisting for more than three months and pain intensity greater than 3 points~     in the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates~     Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with~     aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week~     with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity~     and general disability assessed eight weeks after randomization. Secondary outcomes will be:~     pain intensity and general disability evaluated six months after randomization; global~     impression of improvement, specific disability and dynamic balance, evaluated eight weeks~     and six months after randomization. We expect that the results of this study contribute to~     the clinical decision-making with respect to pain reduction and, consequently, improving~     balance and functionality of elderly with chronic low back pain.~   "
25066|NCT02729090|"~     The Peripheral Arterial Disease prevalence is around 3-10 % of the world population.~     Exercise plays an important role in treating these patients.~   "
25016|NCT02729766|"~     Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is~     a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is~     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered~     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent~     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with~     hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH)~     secretion (SIAD). Because patients with SIAD usually have several comorbidities and~     different medications, studies investigating the physiological effects are difficult to~     interpret. Therefore a model to study the possible physiological effect of SGLT2-inhibitors~     in hypotonic hyponatremia as in SIAD is needed.~      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on~     serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.~   "
25017|NCT02729753|"~     This study will evaluate the CryoBalloon™ Full Ablation System for the ablation of human~     esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated~     to the objective of the study~   "
25018|NCT02729740|"~     The primary objective of this study is to gather post market data on the Penumbra SMART~     Coil™ System in the treatment of intracranial aneurysms and other malformations.~   "
25019|NCT02729727|"~     To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the~     ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy~   "
25020|NCT02729714|"~     The purpose of this study is to see if the study drug, suvorexant, is safe and effective in~     treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a~     total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of~     insomnia will participate in the study at this site~   "
25021|NCT02729701|"~     The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated~     by peri- and post-menopausal women at moderate risk for development of breast cancer.~   "
25022|NCT02729688|"~     Objective of this study are to compare the interface pressure by applying ordinary elastic~     bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who~     could apply the optimal pressure with OEB and CPG-EB.~   "
25023|NCT02729675|"~     The purpose of this project is to study the efficacy of a delivery system to offer fresh~     fruits and vegetables (F&V) at discount prices for purchase at worksites in conjunction with~     educational interventions on increasing employees' F&V consumption in comparison to an~     intervention receiving fruit and vegetable markets alone or a comparison intervention.~   "
25024|NCT02729662|"~     A longitudinal clinical study to investigate the changes before and after administration of~     tolvaptan in patients whose clinical course is monitored prior to the approval of tolvaptan~     will employ a method different from that used in the TEMPO study.~   "
25025|NCT02729649|"~     ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable~     for extended home rehabilitation and prolonged hospital rehabilitation without therapist~     supervision. The device contains several games which are structured as exercise for disabled~     patients. The primary aim of this study is to correlate efficacy of the arm training with~     ArmAssist robot system to conventional care modified by duration and structure of exercise.~     The secondary aim of this study is to measure the correlation between standard clinical~     assessment scales and ArmAssist-based assessment metrics.~   "
25026|NCT02729636|"~     Functional electrical stimulation (FES) is multi-pad system that allows fast optimization of~     stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic~     real-time control of ankle joint during FES assisted walking. The main aim of the present~     study is to compare the effects of functional electrical stimulation gait training after~     stroke and overground conventional physical therapy. With the assumption that the advanced~     method of functional electrical stimulation will improve gait parameters and functionality~     in patients with foot drop before and after FES treatment the objectives of this study are~     to examine the effects of functional electrical stimulation using FES:a method on indicators~     of walk and function in patients with foot drop before and after FES treatment.~   "
25027|NCT02729623|"~     Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of~     standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological~     treatment for neuropathic pain. The objective of this study is to explore the~     pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler,~     (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating~     dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg~     / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis~     Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events~     will be monitored following the inhalation.~   "
25028|NCT02729610|"~     To investigate if bronchial blocker is more suitable for one-lung ventilation during~     thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the~     double-lumen endobronchial tube.~   "
25029|NCT02729597|"~     The natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown.~     The investigators designed a 5-year longitudinal neuropsychological and neuroimaging~     follow-up study to address this issue. Myotonic dystrophy type 1, myotonic dystrophy type 2~     patients, and healthy controls were enrolled. All participants undergo clinical-neurological~     examinations, neuropsychological analyses according to a 13-item neuropsychological test~     battery, and 3T-brain MRI including voxel-based morphometry and diffusion tensor imaging at~     baseline and at follow-up using identical examination protocols.~   "
25030|NCT02729584|"~     The study aims at evaluating in normal weight and obese subjects those factors such as taste~     sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid~     and energy metabolism in order to design personalized nutritional strategies.~   "
25031|NCT02729571|"~     Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage).~     The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult~     participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose~     (5x10E05 CFU/0.1mL) (n=9 in each group). Upon favourable safety review by the DSMB for all~     18 adults up to day 28 after study vaccination, the second stage will commence in thirty-six~     (36) HIV unexposed, BCG naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or~     MTBVAC at one of three different dose levels ( (n=9 in each group).~   "
25032|NCT02729558|"~     Objective: To improve local control following complete resection of a single brain~     metastasis using fractionated local stereotactic radiotherapy, whilst maintaining~     neurological functioning, neurocognition and quality of life.~      Study design: Multicenter randomized phase III, with at least three high-volume Dutch~     centers participating in the trial. Stratification on primary tumor type and age.~      Study population: Patients undergoing complete resection of a single brain metastasis,~     confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.~      Study intervention: Patients will be randomized between observation alone (standard arm) and~     local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study~     arm).~      Main study parameters: Primary objective: local control rate at 6 months. Secondary~     objectives: local control rate at 12 months, neurological functioning, freedom from clinical~     neurological progression, performance status, quality of life, toxicity, steroid use,~     neurocognition and overall survival.~   "
25033|NCT02729545|"~     This study evaluates the efficacy and safety in improving ovarian function of polycystic~     ovarian syndrome in adults. Half of patients will receive Dong's extra-point acupuncture~     therapy, while the other half will receive Diane-35 as the control group.~   "
25034|NCT02729532|"~     A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study~     the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to~     TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic~     cascade before starting TB treatment; and 4) loss to follow-up after initiation of TB~     treatment.~   "
25035|NCT02729519|"~     Balloon predilatation of the aortic valve has been regarded as an essential step during the~     transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested~     that aortic valvuloplasty may be harmful and that high success rate may be obtained without~     prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and~     using new generation balloon expandable prothesis is associated with a better net clinical~     benefit in comparison with procedure performed with pre dilatation.~   "
25036|NCT02729506|"~     Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common~     malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new~     patients a year. The intermediate stage of HCC is controlled by radiological interventions~     such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y~     radioembolization is increasingly being used in clinical practice, there is no high quality~     clinical evidence to justify this. To date, no prospective studies have been performed~     comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized~     controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients~     with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients~     in each arm from. Investigators will compare between the two groups the time to progression~     (TTP) as the primary outcome and also examine time to local progression (TLP) as well as~     other factors like overall survival, response to therapy, toxicities and adverse events,~     quality of life and treatment-related costs.~   "
25037|NCT02729493|"~     This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or~     refractory liver cancer with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour~     cells that express the EPCAM protein on the cell surface.The study will determine if these~     modified T cells help the body's immune system eliminate tumour cells.The trial will also~     study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and~     the impact of this treatment on survival.~   "
25038|NCT02729480|"~     The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation~     for the treatment of neuropathic pain.~   "
25039|NCT02729467|"~     The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P~     (CYP)3A4 and p-glycoprotein (PgP) inhibitor, and rifampicin, a CYP3A4, uridine~     5'-diphospho-glucuronosyltransferase (UGT), and PgP inducer, and an inhibitor of organic~     anion-transporting polypeptide (OATP), on the single-dose pharmacokinetics (PK) of~     JNJ-53718678 in healthy adult participants.~   "
25040|NCT02729454|"~     Introduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the~     therapy also has its importance by means of exercises which maintains the muscular activity~     and preserve mobility. One of the techniques that has been used for physical therapy is the~     mental practice of the mental simulation of movement, aiming at learning or improvement of~     motor skills through the cortex areas of activation responsible for the movement of~     preparation before it is executed. In patients with Parkinson's disease motor anticipation~     this system is compromised, culminating in the march changes and increased risk of falls.~     Objective: To evaluate the effects of mental practice on physical therapy on the march and~     the risk of falls in people with Parkinson's disease. Method: The study is defined as a~     randomized clinical trial with systematic recruitment. Recruitment will be conducted at the~     Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson~     Project: Neurology) and the intervention will be held at the same hospital physiotherapy~     clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice~     a week, lasting 40 minutes for physical therapy and 15 for mental practice.~   "
25041|NCT02729441|"~     The investigators conducted a single center study controlled study involving 20 patients~     with Type 2 Diabetes and hypertension who were randomly assigned to receive ramipril 10mg or~     perindopril 8mg. The primary endpoint was difference in urine albumin-creatinine ratio at~     night time and during the day. Secondary endpoint was measurement of blood pressure.~   "
25042|NCT02729428|"~     The overall goal of observational study is to examine the age-related and habitual exercise~     training status-related differences in structural and functional changes in the human brain,~     detected by magnetic resonance (MR) imaging.~   "
25067|NCT02729077|"~     This study investigates the incidence of postoperative respiratory complications (PRCs)~     including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery,~     and failure to wean from ventilator within 48 hours of surgery - in patients with and~     without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).~   "
25527|NCT02723045|"~     To determine if there is a difference in the quality of life in between patients who~     undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty~   "
25043|NCT02729415|"~     Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of~     Caucasian men and women, respectively, over the age of 50. The percentage of men and women~     affected over the age of 70 increases to 80% and 60% of Caucasian men and women,~     respectively. Although alopecia is considered a minor dermatologic condition, it is seen as~     a serious condition with major life consequences by those with alopecia and has been~     associated with increased incidence of myocardial infarction, hypertension and~     hypercholesterolaemia. Androgenetic alopecia is associated with feelings of anxiety,~     depression and various personality disorders among men and women due to physical appearance.~     Depression, anxiety, aggressiveness, impaired quality of life and social inadequacy have~     been documented. The presence of alopecia in women is particularly stressful.~      ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells,~     include regenerative cell populations derived from adipose tissue and thus are potentially~     important to multiple disease processes and therapeutic applications for the repair and~     regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells~     may promote hair regeneration by increasing the hair-inducing ability of dermal papillae~     (DP) cells.~      The general objective of this study is to conduct a safety and feasibility study of a single~     injection of autologous adipose-derived SVF cells for the treatment of alopecia.~   "
25044|NCT02729402|"~     The subjects will be age 65 years and older, with no upper limit of age range with hearing~     loss that are candidates for standard-of-care cochlear implant.~      Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month~     intervals.~   "
25045|NCT02729389|"~     The purpose of this research study is to investigate how social standing in a game of~     Monopoly may influence behavior.~   "
25046|NCT02729376|"~     This is an open label, single dose, 1 period study of [14C] galeterone.~   "
25047|NCT02729363|"~     Our goal is to improve the self-management of pain and stress in adult outpatients with~     sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation~     (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid~     analgesics are primarily used to treat SCD pain while self-managed behavioral modalities~     such as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain~     and stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal~     (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement~     to analgesic therapies will address the paucity of self-management strategies for~     controlling pain in SCD. GR is a simple and cost-effective non-drug intervention that could~     reduce pain and stress in outpatients with SCD. GR is an intervention where outpatients with~     SCD are directed to listen to and view audio-visual recordings while they visualize~     themselves being immersed in that scene.~   "
25048|NCT02729350|"~     The goal of this research study is to improve the self-management of pain, stress, and~     cognitive/affective symptoms that may result in adult inpatients with sickle cell disease~     (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress~     reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are~     primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are~     rarely used, particularly, in inpatient settings. Little is known about the effects or~     mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD~     hospitalized with pain. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis~     theory offer insights for understanding the mechanisms. Adding GR as a supplement to~     analgesic therapies will address the dearth of self-management strategies for controlling~     pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain~     and stress in inpatients with SCD. GR is an intervention where inpatients with SCD are~     directed to listen to and view audio-visual recordings while they visualize themselves being~     immersed in that scenario.~   "
25049|NCT02729337|"~     The investigators propose to develop a comprehensive, text messaging-based HIV prevention~     program for Ugandan adolescents 18-22 years of age.~   "
25050|NCT02729324|"~     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC).~     Although intensity modulated radiation therapy (IMRT) has been widely used in China~     nowadays, radiation dermatitis is still common. It has an impact on pain and quality of~     life, and if severe, may lead to interruption of the radiation schedule for the patient.~     Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of~     radiotherapy for preventing acute radiation-induced skin toxicity in China. However, as long~     as grade ≥2 radiation dermatitis is developed, trolamine is not allowed to use any more.~     Medical Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and~     treatment of radiation dermatitis. It could be used during the course of radiotherapy, even~     when grade ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the~     effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and~     treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for~     patients with NPC, compared with trolamine.~   "
25051|NCT02729311|"~     Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement~     program for people with dementia (affected individuals) that is taught by trained~     instructors and combines physical, mental and social activities. The Paired PLIÉ Program is~     an adapted version designed for pairs of affected individuals and care partners. The goal of~     this study is to perform a randomized, controlled trial (RCT) with a delayed start design to~     examine the effects of the Paired PLIÉ Program on function and quality of life in affected~     individuals and care partners.~   "
25052|NCT02729298|"~     TP-0903 is a novel oral inhibitor that targets AXL kinase. Preclinical studies have shown~     promising antitumor activity of TP-0903 as a single agent against a variety of tumor types~     in both in vitro and in vivo studies.~      This first-in-human study is conducted to identify the maximum tolerated dose (MTD) and~     dose-limiting toxicities (DLTs) of TP-0903 administered orally to patients with advanced~     solid tumors.~      The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary~     anti-tumor activity profiles.~   "
25080|NCT02728908|"~     An open study evaluating the diagnostic accuracy of a microwave-based device to detect~     traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with~     confirmed vs excluded TICH~   "
36849|NCT02574689|"~     This pilot study represents an initial foray into delivering home-based~     individually-tailored physical activity interventions for cancer risk reduction among~     African American women in the Deep South.~   "
25053|NCT02729285|"~     The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients.~     Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar~     anesthesia saves operative time and money compared to general analgesia, the intraoperative~     pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been~     demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy,~     posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so~     forth. The aim of the investigators study is to determine the safety and preemptive~     analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD~     surgery under retrobulbar anesthesia.~   "
25054|NCT02729272|"~     The aim of this randomized trial was to compare the degree of surgical smoke obstructing~     vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in~     colpotomy during total laparoscopic hysterectomy.~   "
25055|NCT02729259|"~     This study is designed to find additional methods to reduce pain during wound care. In this~     study the investigators use virtual reality (a form of distraction) in addition to pain~     medication during a burn wound care.~   "
25056|NCT02729246|"~     The main purpose of this project is to further explore the metabolic effects and the~     mechanisms underlying the improvement in glucose homeostasis following bariatric surgery.~     The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both~     pre-diabetic as well as diabetic subjects with obesity will be included. This part of the~     project focuses on patients with manifest T2D and they will be assigned to surgical and~     non-surgical intervention, respectively, in a strictly controlled and randomized manner.~   "
25057|NCT02729207|"~     The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in~     comparing with placebo in the treatment of acute pain due to ankle sprain~   "
25058|NCT02729194|"~     Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular~     endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which~     are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA~     approved for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional~     Pazopanib dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily.~     Investigators hypothesize that administration of pazopanib with low fat meal would be safe~     and feasible with secondary implications of higher pazopanib levels; potentially translating~     into greater anti-tumor efficacy in advanced renal cell cancer, with significant cost~     savings. In the proposed pilot study, investigators seek to test the feasibility and~     practicality of this approach and gather preliminary data on adverse effects and the safety~     profile. Investigators hope to ameliorate any potential for greater toxicities with a~     dynamic dosing design that incorporates adverse events from each cycle into dosing for the~     next cycle and a structured symptom specific plan.~   "
25059|NCT02729181|"~     The investigators hypothesize that treatment with non-invasive spinal decompression reduces~     discogenic low back pain (LBP), decreases visual analog pain scale scores, increases~     activities of daily living and decreases medication use.~   "
25060|NCT02729168|"~     An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine~     INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.~   "
25061|NCT02729155|"~     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to~     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for~     prevention of contrast-induced acute kidney injury in patient undergoing coronary~     angiography and angioplasty~   "
25062|NCT02729142|"~     The optimal management of calcium and phosphate metabolism regulation in chronic kidney~     disease (CKD) is important in preventing fracture risk and vascular calcification and thus~     morbidity and mortality, global and vascular.~      Kidney transplant in a CKD context, usually with a pre-existing underlying renal~     osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression~     protocols still often made up of high-dose corticosteroid therapy, are all theoretical~     factors of post-transplantation bone disease. For other solid organ transplants, even though~     there is generally no underlying renal osteodystrophy before the transplant, the proportion~     of osteoporotic patients at the time of transplant is substantial. The bone risk in the~     immediate post-transplant period is notable.~      Patients' follow-up is based on biological, radiological and histological tools. Bone~     densitometry (DXA) is used to measure bone mass. However, recent international~     recommendations do not consider DXA as a valid tool to assess bone health in CKD patients.~     Moreover, it is less informative than peripheral quantitative tomography resolution~     (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise,~     allowing a three-dimensional study of the trabecular microarchitecture and compartmental~     volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of~     radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of~     the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular~     (blood pressure, Doppler of the supra-aortic trunks).~      TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months),~     the bone status in patients receiving solid organ transplantation in the University~     Hospitals of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in~     combination with classical biological and cardiovascular monitoring. Transplantation is an~     important activity in these two hospitals and this protocol provides the same bone follow-up~     for all solid organ transplants, with a reliable, efficient, non-invasive and low-dose~     radiation tool.~      The primary objective of TRANSOS study is to evaluate changes in tibial cortical density~     between the baseline and the 6th month post-transplant measured by HR-pQCT.~   "
25063|NCT02729129|"~     Air pollution exposure is a major environmental and public health concern. The findings from~     controlled exposure studies have given biological plausibility to the epidemiological~     associations, and have defined important pathways that may be amenable to intervention.~     Ultimately, there is a need to address how one may protect the public from these detrimental~     effects. Two studies have been performed assessing the cardiovascular effects of wearing a~     face mask in a highly polluted urban area in China in healthy volunteers and patients with~     coronary heart disease. These demonstrated lower blood pressure and increased heart rate~     variability when wearing a face mask as compared to not. The investigators aim to test if~     wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the~     well-known adverse cardiovascular effects.~   "
25064|NCT02729116|"~     This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute~     urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia~     coli or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with~     intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.~   "
25081|NCT02728895|"~     The purpose of this study is to assess the initial tolerability, safety and recommended~     phase 2 dose of vedolizumab intravenous (IV) administered for Graft-Versus-Host Disease~     (GvHD) prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing~     allogeneic hematopoietic stem cell transplantation [allo-HSCT]).~   "
25068|NCT02729064|"~     Intranasal insulin is reported to improves memory performance in patients suffering from~     cognitive impairment. The investigators have previously shown that intraoperative insulin~     administration preserves both short and long-term memory function after cardiac surgery.~     Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin~     concentrations in the cerebrospinal fluid without major effects on peripheral insulin level.~     Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism~     alteration. The goal of the study is to study the effect of intranasal insulin on blood~     glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac~     surgery or endovascular thoracic aneurysm repair.~   "
25069|NCT02729051|"~     This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus~     UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week,~     randomized, double-blind, parallel group multicenter study. This study will test the~     hypothesis that the difference in trough forced expiratory volume in one second (FEV1)~     between treatment groups is less than or equal to a pre-specified non-inferiority margin.~     Alternatively, this study will also test the hypothesis that the difference between~     treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single~     inhaler is being developed with the aim of providing a new treatment option for the~     management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D~     COPD which will reduce the exacerbation frequency, allow for a reduced burden of~     polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL)~     and symptom control over established dual/monotherapies. This study has a 2 week run in~     period where subjects will continue to have their existing COPD medications. At~     randomization, subjects will discontinue all existing COPD medications and will be assigned~     to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100~     mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical~     visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2),~     Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be~     conducted at 1 week after the end of treatment period or after early withdrawal visit.~     Approximately, 1020 subjects will be enrolled in this study. There will be two~     pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be~     assigned to subset A and approximately 60 subjects will be assigned to subset B. The total~     duration of subject participation will be approximately 27 weeks, consisting of a 2-week~     run-in period, 24-week treatment period and a 1-week follow-up period.~   "
25070|NCT02729038|"~     This study will be conducted to determine if altered renal function affects the plasma~     pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon~     renal impairment are required. The objective of this study is to compare the~     pharmacokinetics of gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose~     in normal healthy subjects compared with subjects with mild, moderate, and severe renal~     impairment, and with subjects with end stage renal disease (ESRD). This is a Phase I,~     nonrandomized, open-label, parallel-group, multi-center, multi-part study. In Part 1, up to~     16 subjects with normal renal function will be matched to approximately 8 subjects with~     moderate renal impairment, and approximately 8 subjects with severe renal impairment and/or~     subjects with ESRD not on hemodialysis for a total of approximately 32 subjects. In Part 2~     (optional), approximately 4 to 8 subjects with normal renal function (if enrolled),~     approximately 4 to 8 subjects with mild renal impairment, and approximately 4 to 8 subjects~     with ESRD on hemodialysis will be enrolled for a total of approximately 12 to 24 subjects.~     The duration from Screening to the Follow-up Visit will be approximately 44 days for Part 1~     and approximately 50 days for Part 2.~   "
25071|NCT02729025|"~     A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)~     inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).~   "
25072|NCT02729012|"~     The main objective of RinASol project is to assess in patients with seasonal Allergic~     Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard~     saline solution on nasal inflammation by means of nasal cytology.~      The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom~     Score 5)~   "
25073|NCT02728999|"~     Patient/Population: Women over the age of 18, who are not pregnant and are undergoing~     benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.~      Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep~     Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which~     is 30 degrees.~      Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and~     the difference in Trendelenburg between the two arms. Additional outcomes included will be~     end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and~     arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and~     conversion to laparotomy.~   "
25074|NCT02728986|"~     The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management~     when two different compression systems are used.~   "
25075|NCT02728973|"~     Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark,~     this is a new concept for the integration of the latest study of the surgical, anesthesia,~     and nursing. The purpose of optimization measures, reduce patient trauma stress, promote~     early rehabilitation of patients. The investigators plan to compare the feasibility,~     clinical effectiveness, and cost savings of an ERAS program with traditional treatment~     program at a major teaching hospital in China.The investigators will apply ERAS plan or~     traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients,~     respectively. And data Compare the two programs about the incidence of postoperative~     complications, postoperative hospital stay, cost of hospitalization, and readmission rate~     will be collected.~   "
25076|NCT02728960|"~     The primary purpose of this study is to validate the High Definition Fiber Tracking~     (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in~     Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and~     normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to~     develop a statistically sound range for the metrics derived from HDFT.~   "
25077|NCT02728947|"~     To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly~     in patients with early-stage Parkinson's disease~   "
25078|NCT02728934|"~     The purpose of this study is to compare the proportion of patients with an infusion reaction~     in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.~   "
25079|NCT02728921|"~     To study if plasma volume expansion is influenced by the rate at which a colloidal solution~     is administered in patients with a systemic inflammatory response induced by major abdominal~     surgery.~      Randomization will be performed postoperatively at the day of surgery with a 1:1 ratio with~     no stratification and the study drug will be given as a slow (3 hours) or rapid (30 minutes)~     intravenous infusion.~   "
36876|NCT02574338|"~     The aim of this study is to compare the effectiveness and safety of Foley's catheter and~     misoprostol in cervical ripening.~   "
25082|NCT02728882|"~     This single-arm, multicenter Phase 2 trial will treat the patients who have Recurrent or~     refractory diffuse large B cell lymphoma with an infusion of the patient's own T cells that~     have been genetically modified to express a chimeric antigen receptor (CAR) that will bind~     to tumour cells that express the EPCAM protein on the cell surface.The study will determine~     if these modified T cells help the body's immune system eliminate tumour cells.The trial~     will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the~     patient's body and the impact of this treatment on survival.~   "
25083|NCT02728869|"~     Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in~     children aged less than 5 years worldwide and are reported to infect nearly every child by~     the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income~     countries in Africa and Asia and are related to poor health care. In view of high global~     RVGE burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion~     of rotavirus vaccine in all the national immunization programs.~      Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines~     which are stable for recommended duration at storage temperature between 2-8 °C. However, if~     these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due~     to lost potency. It is very difficult to maintain the cold chain required to conserve the~     vaccine potency particularly in developing and low income countries, resulting in large~     amount of vaccine being wasted and in worst case scenario, endangering the lives of~     potential recipients. The WHO estimates that nearly half of freeze-dried and quarter of~     liquid vaccines are wasted each year. One of the biggest contributors to this wastage is~     disruption of the cold chain systems.~      Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine~     comprising of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat~     stable rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C~     and 12 months at 37 °C. This new heat stable formulation (HSRV) could be transported in~     non-refrigerated supply chain significantly reducing the cost and complications associated~     with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus~     vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in~     regions where majority of rotavirus burden exists and has potential to partially or~     completely eliminate cold chain dependence.~      The current study has been designed to test for the first time in humans, the safety and~     tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety~     and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq®~     vaccine.~   "
25084|NCT02728856|"~     To evaluate the human eye irritation potential of two test sunscreen formulation~   "
25085|NCT02728843|"~     The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in~     patients with Parkinson's disease. Participants will be randomized to receive one of four~     different dosages of deferiprone or placebo, and will take the assigned study product twice~     a day for nine months.~   "
25086|NCT02728830|"~     The ultimate goal of the study is to identify potential biomarkers, immune gene expression~     signatures, and co-stimulatory pathways that may be used to understand the effect of immune~     checkpoint inhibitors on gynecologic cancers.~   "
25087|NCT02728817|"~     The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the~     construction of hemodialysis arteriovenous fistula. In this technique, the radial artery~     pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of~     this study is to compare the safety and efficacy of this technique with the traditional~     end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular~     access in hemodialysis patients.~      The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous~     juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of~     maturation and patency.~   "
25088|NCT02728804|"~     This clinical trial studies the use of the financial impact assessment tool in patients with~     colorectal cancer that has spread from the primary site to other places in the body.~     Gathering information about patients with colorectal cancer over time may help doctors~     better understand the financial impact of cancer and help patients avoid financial problems~     during treatment.~   "
25089|NCT02728791|"~     Correlation study between the data provided by two measurement systems, trans- pulmonary~     thermodilution and ClearSight © (non invasive), to determine the interest in routine use~     (cardiac output, cardiac index, stroke volume and blood pressure).~   "
25090|NCT02728778|"~     The main objective of the trial is to test whether a single application of botulinum toxin A~     into the glabellar region will lead to emotional stabilization in borderline personality~     disorder through paralysis of facial muscles/attenuation of negative emotions.~   "
25091|NCT02728765|"~     To study the frequency of obstructive sleep apnea (OSA) and continuous positive airway~     pressure (CPAP) treatment response in patients with non-alcoholic fatty liver disease~     (NAFLD).~      It is hypothesized that CPAP treatment may improve the activities of NAFLD in those with~     concomitant OSA.~      A screening study for OSA followed by a randomized controlled trial of patients with biopsy~     proven NAFLD being followed up at the hepatology clinic.~      Home sleep study, Epworth sleepiness score (ESS), paired proton magnetic resonance~     spectroscopy (MRS), transient elastography by fibroscan, serum cytokeratin-18 fragment,~     liver function tests and liver biopsy (only for those with fibroscan evidence of advanced~     liver fibrosis).~      Patients with confirmed symptomatic OSA will be randomized to receive auto CPAP or~     subtherapeutic CPAP as control over 6 months.~      Primary outcome: changes in intrahepatic triglyceride content (IHTG) measured by proton-MRS~     after 6 months of auto CPAP versus subtherapeutic CPAP.~   "
25092|NCT02728752|"~     Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating~     Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM study)~   "
25093|NCT02728739|"~     The purpose of this study is to determine the prevalence of moderate-to-severe Mitral~     Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.~   "
25094|NCT02728726|"~     The study is designed to determine whether patients who receive sugammadex immediately after~     tracheal extubation will exhibit a decrease in the incidence of postoperative residual~     paralysis and an associated decrease in the incidence of postoperative respiratory~     depression.~   "
25095|NCT02728713|"~     The purpose of this study is to determine if there is a measurable change in visual function~     as a direct result of the application of osteopathic cranial manipulative medicine. The~     study will also attempt to determine whether any changes noted remain after withdrawal of~     the treatment.~   "
25096|NCT02728700|"~     This pilot phase I/II trial studies the side effects and how well sirolimus and~     mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with~     hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological~     therapies, such as sirolimus and mycophenolate mofetil, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop tumor~     cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell~     transplant may be better in preventing graft-versus-host disease.~   "
25097|NCT02728687|"~     Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have~     multiple side effects. To find out if a menthol cream alone or with added mannitol treats~     PDPN effectively, 90 participants with PDPN, after one month of observation, will receive~     randomly assigned menthol cream or the same cream with mannitol added for 3 months with a~     crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and~     interference scores, DN4 scores, cream % effectiveness and side effects will be compared.~   "
25098|NCT02728674|"~     This is a web-based randomized survey to evaluate management of respiratory symptoms among~     physicians in Sweden. The aim of this study is to determine if there is a gender bias in the~     diagnosis of COPD and how often physicians identify that chronic refractory breathlessness~     requires treatment as compared to refractory pain.~   "
25099|NCT02728661|"~     PACE is a patient-centered weight loss program that was developed specifically for knee~     replacements based on input from stakeholders, including knee replacement patients, physical~     therapists, and orthopedic surgeons. In this pilot study, participants undergoing knee~     replacement will be randomized to either start a weight loss program before surgery (PACE)~     or after surgery (Delayed PACE). Both programs will receive a 14-week intervention and~     complete assessments at baseline (up to 6 weeks prior to surgery), 12 weeks after surgery,~     and 26 weeks after surgery.~   "
25100|NCT02728648|"~     Oxycodone has been in clinical use for decades. It is an effective alternative to morphine~     for moderate to severe acute or chronic pain and has been found to improve quality of life.~     The drug has been used parenterally or orally as perioperative analgesia or for cancer pain~     relief (Kalso 2005). Despite of its long clinical experience, prescribing errors and misuse~     may lead to addiction and accidental overdose (Berling et al. 2013, Boyle and Dosenbaum~     2014). Currently, little is known about the pharmacokinetic properties of intravenous~     oxycodone among paediatric patients in this region even though the drug has been used in~     children in other countries such as Finland. Therefore, a pharmacokinetic-pharmacodynamic~     study of oxycodone among Malaysian pediatric patients is warranted.~   "
25101|NCT02728635|"~     The purpose of this study is to collect data to help researchers better understand the~     different ways that women or men store fat (apple shape versus pear shape).~   "
25102|NCT02728622|"~     A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer~     resistant or refractory to platinum and taxane.~   "
25103|NCT02728609|"~     The purpose of this study is to compare the pro-inflammatory and anti-inflammatory~     cytokines, protein content, and white blood cell (WBC) count present in the peritoneal fluid~     and plasma of trauma patients who undergo one of two different methods of open abdominal~     closure. Following analysis of the peritoneal fluid and serum samples, comparison of the~     results between the two groups will be completed and correlated with the overall organ~     function.~   "
25104|NCT02728596|"~     This randomized clinical trial studies prophylactic colony stimulating factor management in~     patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and~     with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop~     febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number~     of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the~     risk of infection. Colony stimulating factors are medications sometimes given to patients~     receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given~     to patients based on guidelines. Some clinics have an automated system that helps doctors~     decide when to prescribe them when there is a high risk of developing febrile neutropenia.~     Gathering information about the use of an automated system to prescribe prophylactic colony~     stimulating factor may help doctors use colony stimulating factor when it is needed.~   "
25105|NCT02728583|"~     The main aim of the study is to investigate the effect of daily consumption of a margarine~     enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.~      The study also aims to investigate the effect of plant sterols and fish oil on fasting total~     cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein~     cholesterol (HDL-C) and non-HDL-C.~      At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations~     will be explored.~   "
25106|NCT02728570|"~     The investigators have hypothesized that dietary flavonoids reduce insulin resistance and~     subclinical inflammation secondary to reductions in intestinal inflammation and permeability~     and that these events are mediated through alterations in gut microbiota composition. To~     test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled~     diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en;~     Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10~     mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be~     prepared and fed for 6 weeks each in a randomized cross-over design with endpoints~     determined in duplicate during the last week of each diet period.~   "
25107|NCT02728557|"~     This study will assign patients to two types of psychotherapies in treating people with a~     major depression disorder, expressive versus supportive techniques, and will examine their~     ability to benefit from treatment based on their attachment orientation. This is a four~     month protocol, with a year follow up period, will compare patients receiving~     supportive-expressive treatment with either expressive focus or supportive focus.~   "
25108|NCT02728544|"~     Post exercise irisin levels in PWS patients Obesity, short stature, hypogonadism, hypotonia~     and impaired cognition are the major clinical features of Prader-Willi syndrome (PWS), a~     complex neurogenetic disorder due to lack of expression of paternal genes in the chromosomal~     region 15q11-13. Abnormal body composition with decreased muscle mass and increased fat mass~     contributes to low resting energy expenditure in PWS. Severe caloric restriction in the~     range of 800 kcal per day along with daily exercise regimens are needed to prevent weight~     gain and complications of obesity in this population.~      Brown adipose tissue (BAT) once thought to be present only in infants, but now known to be~     present in adults as well, differs from the more abundant white adipose tissue (WAT) by~     dissipating energy through thermogenesis as a result of increased activity of the~     mitochondrial uncoupling protein (UCP-1). Recently evidence shows that exercise activates~     mitochondrial UCP-1 in subcutaneous WAT cells resulting in conversion of WAT to BAT-like~     adipocytes (Beige or BRITE adipose tissue). Various factors including natriuretic peptides,~     interleukin-6 and myokines (irisin, fibroblast growth factor 21, and ß-aminoisobutyric acid)~     appear to mediate the effects of exercising muscle on subcutaneous adipocytes.~      Decreased amount and/or activity of BAT might contribute to the lower energy expenditure and~     extreme difficulty in weight-control in PWS. Lower levels or decreased myokine production~     could result in failure to convert subcutaneous WAT to Beige or BAT-like adipocytes, and~     therefore minimize or negate the otherwise beneficial metabolic effects of exercise. Direct~     measurement of peak oxygen uptake in PWS adults show that this population has markedly lower~     VO2 values compared with normal BMI-matched controls. BAT activity in vivo can be accurately~     measured only by performing PET/CT scans which include administrating radioactive tracers.~     For ethical reasons, direct assessment of BAT is not possible for purposes of clinical~     research in PWS individuals.~      The investigators propose to study humoral responses to exercise in 16 (8 males) PWS~     adolescents and young adults and compare results with responses in a similar number of sex,~     age, and BMI-matched controls. At an initial one-hour meeting study participants will learn~     to perform aerobic (treadmill) exercise and resistance training under the supervision of an~     experienced exercise physiologist. Exercise intensity will be assessed by direct measurement~     of VO2 max. On a different day, a blood sample will be drawn before and immediately at the~     conclusion of the same exercise regimen. Blood samples will be assayed for irisin,~     interleukin-6, atrial natriuretic peptide, FGF-21, in addition to glucose, growth hormone,~     cortisol, norepinephrine, and lactate.~      The investigators hypothesize that PWS participants will show weaker humoral responses to~     similar exercise regimens compared to normal control subjects. Data showing lower levels of~     myokines, such as irisin, following exercise in PWS might suggest that inadequate conversion~     of WAT to BAT-like adipocytes in subcutaneous adipose tissue results in decreased~     thermogenesis and abnormally low energy expenditure in this population. Potentially,~     development of pharmacologic agents which mimic irisin or other myokines by activating UCP-1~     and converting WAT to BAT-like adipocytes could offer a new approach to weight-control in~     PWS individuals.~   "
25109|NCT02728531|"~     Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along~     with recent data showing the encouraging efficacy of bendamustine, the investigators seek to~     integrate the synergistic effects of these medicines in alternating cycles as induction~     therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with~     bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate~     the efficacy and safety of stem cell mobilization in this pilot study~   "
25110|NCT02728518|"~     The investigator's goal in this study is to evaluate the efficacy and safety of nebulized~     amikacin versus intravenous amikacin in patients with hospital and ventilator acquired~     pneumonia in surgical patients admitted to the intensive care units infected with gram~     negative bacilli~   "
25111|NCT02728505|"~     Single-center, prospective, placebo controlled trial of tolerability and safety of~     low-concentration SinuSurf sinus irrigation solution in normal subjects. Forty (40) healthy~     subjects aged 18-65 will be enrolled in the study.~   "
25112|NCT02728492|"~     Quisinostat besides its own efficacy, which can potentially lead to better results of~     polychemotherapy and increase the mean time to progression, it may be demonstrated that~     Quisinostat leads to sustained tumor sensitivity to platinum drugs. In this study safety and~     tolerability of multiple administrations of Quisinostat in doses ranging from 8 mg to 12 mg~     combined with standard backbone chemotherapy in patients with non-small cell lung cancer~     (second line) and ovarian cancer (second and subsequent lines) will be investigated.~   "
25113|NCT02728479|"~     Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating~     blood vessels in the treatment of peripheral artery disease.~      The aim of this registry is to collect prospectively and systematically clinical research~     data from patients undergoing PTA. This registry is an open-end observational study to~     assess the characteristics and outcomes in patients with undergoing PTA.~   "
25114|NCT02728466|"~     There is a question regarding the role of higher flavanol oligomers (procyanidins) and of~     intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol~     intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are~     absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are~     not absorbed and are catabolized by the colonic microflora. The catabolites enter the~     circulation. Phenolic acids and valerolactones represent a significant proportion of these~     catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The~     vascular effects of these colonic microbiome-derived flavanol derivatives have not been~     studied so far. The purpose of the study is to determine the timecourse of endothelial~     function along with flavanol catabolites & metabolites during acute, sustained, and acute on~     sustained ingestion of procyanidins as compared to previously used flavanol interventions,~     and flavanol free control.~   "
25115|NCT02728453|"~     Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk~     secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not~     addressed by currently available treatments. The abnormality results from obesity-induced~     volume overload, increased blood pressure, and myocardial fat accumulation. By improving~     metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type~     2 diabetes-associated myocardial disease. We will assess left ventricular mass, function,~     and lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance~     imaging and spectroscopy as well as echocardiography before and after empagliflozin or~     glimepiride treatment. We expect to observe improvements in left ventricular mass, function,~     and fat content with empagliflozin. The results of the study will help to position~     empagliflozin as an antidiabetic agent with the added value of protecting the heart.~   "
25116|NCT02728440|"~     Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters~     of Patients with Idiopathic Hypogonadotropic Hypogonadism~   "
25117|NCT02728427|"~     Compared with traditional open proctectomy, laparoscopic surgery is associated with less~     pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes~     have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery~     was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some~     studies show that the rates of urinary tract infection, second catheterization, and urinary~     symptom are lower with suprapubic catheterization (SPC) than with transurethral~     catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage~     removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.~      Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC.~     Therefore, investigators perform this prospective randomized trial to compare SPC using CVC~     with TUC in laparoscopic surgery for rectal cancer.~   "
25118|NCT02728414|"~     The purpose of this study is to determine whether the probiotics is effective in the~     treatment of type 2 diabetes.~   "
25119|NCT02728401|"~     The aim of this investigation is to longitudinally quantify host gene expression and serum~     proteins in children with infectious and non-infectious SIRS. The investigators hypothesize~     that children with non-infectious SIRS, with bacterial infection associated SIRS, or with~     viral infection associated SIRS will exhibit distinct patterns of host gene expression and~     serum proteins. The investigators further hypothesize that it should be possible to discover~     sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious~     SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.~   "
25120|NCT02728388|"~     The investigators wish to determine the time to disease progression for benign neurofibromas~     treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy~     (PDT) in patients with neurofibromatosis type 1 (NF1).~      The investigators also wish to measure tumor size for control and treatment tumors in order~     to gain insights into tumor growth rates.~   "
25121|NCT02728375|"~     This research project focuses on the evaluation of an engaging exercise and cognitive~     computer game-based platform and embedded assessment tools for use in clinical practice and~     its transition to use in the home, and elementary classrooms. The goal of our research~     program is to produce innovative therapeutic point-of-care and cost-effective delivery~     system leading to better long-term health outcomes for toddlers and children with~     neurodevelopmental disabilities. The program is grounded on our technological developments~     and on current research documenting the benefits of computer-aided learning tools, exercise~     gaming applications in rehabilitation and principles of adaptive learning and~     neuroplasticity. We will conduct a randomized controlled trial to study the feasibility and~     effectiveness of a computer-aided, game-based repetitive task practice (RTP) program~     designed for training of fine and gross motor skills of the hand-arms and psychomotor skills~     (which) in young children with CP.~   "
25122|NCT02728362|"~     To investigate the functional outcomes and prevalence and severity of knee pain for patients~     undergoing suprapatellar nailing of tibial shaft fractures.~   "
25123|NCT02728349|"~     The purpose of this study:~      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics~     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the~     advanced Glioblastoma Patients ;~   "
25149|NCT02728011|"~     The purpose of this study was to examine the feasibility and efficacy of computerized~     cognitive exercises from Scientific Brain Training (SBT), compared to the computer game~     Tetris as an active placebo, in a pilot study of adolescents with~     Attention-deficit/hyperactivity disorder (ADHD).~   "
25124|NCT02728336|"~     The goals of this project are to: 1) explore the potential use of magnetic resonance imaging~     (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2)~     use the MRI-derived data together with a computer model of the cardiovascular system to~     study the relative roles of different factors in the mechanical effects of dyssynchrony in~     failure, and in the response (or lack thereof) to CRT.~   "
25125|NCT02728323|"~     In many countries, caesarean section (CS) rates have been increasing. The international~     literature is unclear regarding the analgesic efficacy of the transversus abdominis plane~     block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method~     of performing this block has been matched with the obtained analgesic effect after a CS. The~     primary goal of the study was to determine whether a correctly performed ultrasound-guided~     TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute~     postoperative pain during the first 72 hours after surgery~   "
25126|NCT02728310|"~     The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration~     (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization~     through an additive or synergistic effect because it can maintain continuous inhibition of~     nociceptive afferents~   "
25127|NCT02728297|"~     Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of~     palmo-axillo-plantar hyperhidrosis~   "
25128|NCT02728284|"~     The purpose of this investigation is to evaluate newer methods of performing cardiovascular~     MRI (CMR) that will provide new kinds of information related to the interplay between the~     cardiac and the respiratory cycles, such as the interaction between the left ventricle and~     the right ventricle during respiration . The primary statistical objective is to provide~     preliminary indications of the relative utility of the investigational imaging software in~     terms of image quality and suitability for routine clinical use. Image quality will be~     expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and~     subjective Likert-type qualitative assessments independently provided by each of multiple~     blinded readers for each image. Suitability for routine use will be assessed in terms of~     imaging time and a binary indicator of whether, in the opinion of the investigator, adverse~     procedural complications (not expected) were encountered during a given imaging session.~   "
25129|NCT02728271|"~     Churg-Strauss syndrome is a rare autoimmune inflammatory disease affecting medium- and~     small-sized blood vessels, causing asthma, abnormalities of the blood, lung diseases, and~     neuropathy. The main cause of death in these patients is heart attack. Without therapy, the~     5-year survival in patients with Churg-Strauss syndrome is 25%. Although with the 5-year~     survival is increased to 62% with the appropriate therapy, many patients remain refractory~     to therapy. The long term outcome of these patients remains grim.~      The aim of this research study is to determine if suppressing the immune system using a~     combination of high dose chemotherapy, antibodies, and radiation followed by stem cell~     transplant will abolish the 'bad' immune system and let the patient's body establish a new~     immune system that does not attack the blood vessels.~   "
25130|NCT02728258|"~     This phase II trial studies how well copanlisib works in treating patients with endometrial~     cancer that has not decreased or disappeared, and the cancer may still be in the body~     despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
25131|NCT02728245|"~     Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs.~     upfront surgery to save ovarian reserve in young women with ovarian endometrioma~   "
25132|NCT02728232|"~     This trial is set to detect the impact of bilateral internal iliac artery ligation on the~     amount of intra-operative blood loss during the hysterectomy procedure done for the~     management of placenta percreta~   "
25133|NCT02728219|"~     The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma~     with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP~     conversion.~   "
25134|NCT02728206|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus~     (HCV)-infected adults who are undergoing liver transplantation.~   "
25135|NCT02728193|"~     The aim of our study was to elucidate the difference in the rates of complication,~     hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and~     overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for~     minimally invasive treatment of very early stage HCC.~   "
25136|NCT02728180|"~     The main purpose of this trial is to determine whether Xingnaojing, intravenously~     administered within 24 hours of symptom onset, improves the 3-month outcome in participants~     with acute ischemic stroke.~   "
25137|NCT02728167|"~     The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR)~     results in reduced blood loss compared to standard liver resection in patients with LM.This~     is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II~     study.~   "
25138|NCT02728154|"~     Gut microbiota play an important role in normal cardiovascular function and pathophysiology~     of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic~     changes which lead to intestinal hypoperfusion and congestion and eventually change gut~     morphology, permeability, function and composition of gut microbiota and cause translocation~     of microbial and endotoxins into the blood stream. Additionally, metabolites derived from~     gut microbiota modulate the pathophysiology of HF. Patients with HF have intestinal~     overgrowth of pathogenic bacteria and increased gut permeability. Accumulating evidence~     demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and~     reduces the incidence of ischemic cardiovascular events. Taking the strong association of~     gut microbiota with HF into account, it is reasonable to speculate that gut microbiota could~     contribute to the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF~     with preserved ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high~     prevalence and a significantly high risk for death in comparison to patient without~     pre-HFpEF. We hypothesize that altered gut microbiota is involved in the initiation and~     establishment of HF and pre-HFpEF.~   "
25150|NCT02727998|"~     The purpose of this study is to combine a single infusion of Ketamine with 7-days of trauma~     focus psychotherapy to relieve post traumatic stress disorder (PTSD) symptoms more~     effectively. This treatment has the potential to produce a significant therapeutic effect~     that otherwise would take months to occur.~   "
25139|NCT02728141|"~     Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain~     threshold. The opioid system is involved in sucrose's ability to reduce pain and distress~     during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and~     sucrose analgesia. In order to compare response to pain and sucrose during heel stick in~     neonates with and without iron deficiency, healthy full-term Chinese infants were randomized~     to receive sucrose or water by syringe beforehand, in conjunction with heel stick for~     metabolic screening.~   "
25140|NCT02728128|"~     The purpose of this study is to identify if circulating platelet cyclic adenosine~     monophosphate (cAMP) levels can be used as a biomarker of milrinone efficacy in children~     following cardiac surgery or undergoing heart transplant.~   "
25141|NCT02728115|"~     Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a first-in-human, dose~     escalation study in which participants with Huntington's Disease will receive 3 intravenous~     injections and will be followed for 5 years to evaluate safety and preliminary evidence of~     effectiveness.~   "
25142|NCT02728102|"~     The study is designed as a Phase II, multicenter trial of vaccination with Dendritic~     cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant~     plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF~     following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is~     hypothesized that the dendritic cell myeloma vaccine will result in improved response in~     patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).~   "
25143|NCT02728089|"~     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and~     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of~     complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or~     complicated pyelonephritis and complicated lower urinary tract infection) in Japanese~     participants. Efficacy will be primarily assessed by microbiological response defined as~     eradication of the baseline pathogen or pathogens.~   "
25144|NCT02728076|"~     This study examines the feasibility to deliver accelerated partial breast irradiaiton (APBI)~     before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller~     volume of breast tissue may be exposed to radiation. The APBI method used in this study is~     3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam~     irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is~     used to plan treatment. In this study, an MRI will be used. Approximately five to eight~     weeks after completion of the APBI, the cancer will be surgically removed.~   "
25145|NCT02728063|"~     The main objective of the study is to evaluate the effect on intestinal permeability of a~     supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from~     irritable bowel syndrome (IBS) with diarrhea predominance.~      Secondary objectives of the study are to evaluate the effects of supplementation with~     Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea~     predominance on intestinal permeability, inflammation of the digestive tract, symptoms and~     comfort.~      Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel~     Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and~     non-inclusion listed below.~   "
25146|NCT02728050|"~     This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte~     colony-stimulating factor [G-CSF]), cladribine, cytarabine, and mitoxantrone hydrochloride,~     when given together with sorafenib tosylate and to see how well they work in treating~     patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome~     (likely to be more aggressive). Drugs used in chemotherapy, such as filgrastim, cladribine,~     cytarabine, and mitoxantrone hydrochloride work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Sorafenib tosylate may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and~     mitoxantrone hydrochloride together with sorafenib tosylate may kill more cancer cells.~   "
25147|NCT02728037|"~     This study will be a randomized, controlled, double-blinded, single-centre superiority trial~     with two parallel groups. The primary outcome will be average myofascial pelvic pain in the~     two weeks following final injection treatment as assessed using the visual analogue scale.~     Randomization will be performed as block randomization with a 1:1 allocation ratio,~     stratified based on opioid use at the time of study enrollment. In total, 60 participants~     will be recruited and randomized, with 30 being assigned to each treatment arm. The study~     will be restricted such that half of the participants enrolled will be current concomitant~     opioid users (for any reason) and half will have not used opioid drugs within the 3 months~     preceding enrollment in the study.~      A third non-randomized arm of 30 participants who are on the waiting list for the chronic~     pain clinic will be enrolled and compared to the two randomized arms. Among this patient~     population and in the setting of the Chronic Pain Clinic it was determined that it would not~     be acceptable to randomize participants to a no-treatment control group. As such, an active~     treatment is being used as comparator in the randomized trial. In order to assess~     participants in the absence of treatment this third non-randomized arm will serve as a~     no-treatment control group.~      Eligibility criteria for this third arm is the same as the main study, with the exception of~     stratification and restriction by opioid use status. Participation in this third arm will~     not exclude a participant from randomization into one of the two main arms of the study.~     Therefore, across the three arms, up to 90 patients will be enrolled in this study.~   "
25148|NCT02728024|"~     The study is undertaken at three German neurosurgical centers (Ulm, Mainz, Stuttgart)~     between March 2014 and March 2015. Inclusion criteria were age ≥ 18 and ≤ 80, diagnosis of~     glioma WHO° II-IV, absence of aphasia impairing communication or consent. In an outpatient~     setting all eligible patients with gliomas were screened for distress (Distress Thermometer~     (DT)) and their need for psychosocial support (Supportive Care Needs Survey-SF34-G (SCNS)).~     Simultaneously their HRQoL was assessed (EORTC QLQ-C30+BN-20 Vers. 3).~      Patients at different disease stages were asked to fill out the questionnaires. At two study~     centers patients were asked to complete the questionnaires prior to their appointment with~     personal instructions in randomly selected cases. At the third study center, they completed~     the questionnaires after their outpatient appointment with personal aid and instructions. At~     the time of investigation, patients were at different stages of treatment (chemotherapy,~     radiation, re-chemotherapy, re-radiation, none, etc.).~   "
25151|NCT02727985|"~     The primary purpose of this study is to compare opioid use post-spinal cord stimulation~     implant at 1, 3, 6, 9 and 12 month intervals in patients who were provided with a weaning~     schedule by the Neuromodulation team (experimental group) versus those who wean on their own~     or with their family doctor (control group; standard care) to determine if one strategy is~     superior to the other.~      The secondary objectives will be to further characterize change in opioid use as it relates~     to pain scores, quality of life and disability from baseline to follow-up assessments. The~     investigators will examine changes in opioid-related adverse events and medication costs to~     help understand the impact of opioid weaning on the patient and the system. The~     investigators will also compare worker's compensation patients with non-worker compensation~     patients to see if they follow the same result pattern.~   "
25152|NCT02727972|"~     This research study is designed to look at the involvement of the glutamate system in~     depression. Each subject will undergo a screening appointment to determine study~     eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule~     availability and will consist of one MRI scan, and PET scan. Subjects will also participate~     in cognitive testing. Depending on camera time, staff availability and subject schedule,~     total study participation may last 1-2 months.~   "
25153|NCT02727959|"~     The IBSEN III study will investigate the incidence of inflammatory bowel disease in South~     Eastern Norway and describe the clinical course of the disease. The investigators will map~     newly diagnosed and treatment naive IBD patients at various levels (epidemiological,~     clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and~     microbial) as a basis to improve targeted and individualized treatment and care. The~     investigators will include incident IBD patients at all local- and university hospitals in~     the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The~     investigators will use standardized and validated registration methods allowing~     comparability with previous national and international IBD cohorts, link data to national~     health registries and collect blood, feces and biopsies for bio banking.~   "
25154|NCT02727946|"~     Early intervention and resuscitation based upon a lot of clinical, laboratory findings make~     a big difference regarding outcome in poly trauma patients, the study uses the dynamic~     lactate change and the difference between arterial and venous CO2, oxygen tension or content~     as indicators for tissue perfusion.~   "
25155|NCT02727933|"~     The primary objective of this study is to describe the safety of the combination of Daklinza~     (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C~     (CHC) genotype 1b patients in real-life conditions when used according to its registered~     indications.~   "
25156|NCT02727920|"~     This study is designed to test the efficacy of energy drinks. This is a double-blinded,~     crossover, randomized clinical trial, measuring the effect of the test drinks compared with~     placebo drink in 200 participants aged 18-70 years.~   "
25157|NCT02727907|"~     Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with~     the use of active comparator and placebo. Total duration of therapy of about 2 years. Study~     hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033~     original drug Rebif®.~   "
25158|NCT02727894|"~     The purpose of this study is to determine whether colorectal cancer diagnosed by screening~     (primary screening colonoscopy, colonoscopy after FOBT) has a better pTNM classification~     than colorectal cancer diagnosed byl other diagnostics (diagnostic colonocopy, CT, MR etc.).~   "
25159|NCT02727881|"~     A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2%~     Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will~     receive injections of ranibizumab. In addition, patients will receive either Squalamine~     lactate 0.2% eye drops or Placebo eye drops. The study duration is 2 years~   "
25160|NCT02727868|"~     The evaluation of the impact of environment on the incidence of cancer is a major public~     health issue. Increased knowledge in this area is necessary for the implementation of~     primary prevention means with appropriate preventive measures but also to the implementation~     of secondary prevention measures with targeted screening actions.~      Among the environmental exposures that may lead to cancer, mutagenic environments are of~     major importance, and the causal link between environmental genotoxicity and cancer has been~     established for a long time. It is also well established that susceptibility to mutation is~     highly variable among individuals. This is explained by genetic polymorphisms of genes~     involved in metabolism and in genome stability.~      The identification of biomarkers of exposure to mutagenic environments is necessary for~     assessing the impact of an environment in humans. Some studies in animals have shown that~     the PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a~     significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a~     genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study~     of healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be~     estimated efficiently and reliably.~      The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of~     spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous~     expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells ,~     spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements).~     Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma~     membrane is easily achievable by flow cytometry.~   "
25161|NCT02727855|"~     To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and~     cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban~     slums in Bangladesh, Investigators will conduct a targeted mass immunization programme,~     using an innovative approach successfully deployed by the Bangladesh government in its~     recent countrywide campaign of MR vaccination of 52 million children aged 9 months to 14~     years (<15 years). Investigators will undertake a census of a geographic population of~     approximately 300,000 persons, with GIS locations of each household. This census will be~     updated every 6 months during the follow-up period to permit tracking of births, deaths, and~     migrations, including changes in location of each individual's residence. Following the~     initial census, the OCV will be offered to all non-pregnant individuals aged 1 to 14 years.~     Operational research and economic studies will evaluate the coverage, feasibility,~     acceptability, demand, costs and cost-effectiveness of this vaccination programme.~   "
25162|NCT02727829|"~     The aim of the present study is to assess the effects of brachial plexus block on~     microcirculation using pefusion index and capillary filling time.~   "
25164|NCT02727803|"~     The goal of this clinical research study is to learn if giving cells called natural killer~     (NK) cells after receiving 1 of 3 pre-treatment plans and a UCB transplant can improve~     response in patients with MDS, leukemia, lymphoma, or MM. The safety of this treatment and~     whether NK cells can lessen the risk of graft versus host disease (GVHD) will also be~     studied.~      If the disease is CD20 positive, you will also receive rituximab on this study in addition~     to what is described above. CD20 is a type of marker for white blood cells. White blood~     cells help protect the body from infections.~      NK cells may kill cancer cells that remain in your body after your last chemotherapy~     treatment. The NK cells will be separated from umbilical cord blood. The device used in the~     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will~     then be grown in the lab to increase the number of NK cells that can be given to you by~     vein.~      Based on your genes, your NK cells may not recover as quickly after transplant. Before the~     transplant, blood will be collected for genetic testing as part of standard screening tests.~     If the genetic test shows that your NK cells will not recover as quickly after transplant,~     you will receive the NK cell infusion.~   "
25165|NCT02727790|"~     The epidemic nature of type 2 diabetes mellitus, along with the downsides of current~     treatments, has raised the need for therapeutic alternatives. The aim of this study is to~     evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral~     electrical stimulation (PES) as an alternative treatment for diabetes.~   "
25166|NCT02727777|"~     The goal of this clinical research study is to learn if TAK-228 can help to control relapsed~     lymphoma. The safety of this drug will also be studied.~   "
25167|NCT02727764|"~     This study will evaluate the safety and tolerability of a single intra-articular~     administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV)~     type 5 vector in subjects with RA and active arthritis in the joint.~   "
25168|NCT02727751|"~     This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects~     with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III~     criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)~     studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total~     based on previous protocol and this study.~   "
25169|NCT02727738|"~     Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the~     control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD)~     untreated patients.~   "
25170|NCT02727725|"~     -  The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization~          Transfer and Inversion Recovery) sequence provides at least as good visualization and~          detection of sub-endocardial scarring, fibrosis, and acute infarction as the current~          gold standard Inversion Recovery (IR) Turbo-Flash sequence.~        -  The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in~          detecting small sub-endocardial scarring than the inversion recovery segmented gradient~          echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the~          accepted current gold standard for the detection of myocardial viability.~   "
25171|NCT02727712|"~     This study intends to compare the combination of general anesthesia (GA) and single-shot~     bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing~     off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA)~     perioperative management of patients, committed to reducing patient's physical and~     psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to~     establish an more effective perioperative management during off-pump coronary artery bypass~     surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation~     safely.~   "
25172|NCT02727699|"~     This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety,~     tolerability and efficacy of Xanamem™ in subjects with mild dementia due to Alzheimer's~     Disease. Subjects will be randomized to receive either 10mg once daily Xanamem™ or Placebo~     at a 1:1 ratio in a double-blinded fashion.~   "
25173|NCT02727686|"~     Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery~     and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and~     have serious consequences such as altered mental status, seizures, coma, and even death.~     Despite significant research into patient demographics and risk factors, the investigators~     have not been able to predict which patients will suffer from delayed post-operative~     hyponatremia to date. At the Barrow Neurological Institute, physicians currently utilize an~     outpatient screening protocol to monitor patients' sodium levels after surgery, but this has~     yet to be effective for reducing readmissions following pituitary surgery. The etiology of~     delayed post-operative hyponatremia has been linked to water and sodium dysregulation in the~     post-operative period. It has been shown that post-operative day 1-2 sodium levels are~     statistically lower in patients who develop delayed hyponatremia, however, the numerical~     differences are not large enough to guide clinical management. The investigators propose~     that a water load on post-operative day 1 may expose underlying sodium/water dysregulation~     in the early post-operative period. This would improve physicians' understanding of the~     pathophysiology of post-operative hyponatremia, and it may help to serve as a screening tool~     for these patients in the future.~   "
25174|NCT02727673|"~     The aim of this study is to establish a platform of detecting and sorting circulating tumor~     stem cells from peripheral blood in HCC patients; to investigate the relationship between~     circulating tumor stem cells and their effects on postoperative recurrence and metastasis,~     in order to provide a new therapeutic target for hepatocellular carcinoma treatment.~   "
25175|NCT02727660|"~     This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD~     exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6~     μg, all administered BID.~   "
25217|NCT02727114|"~     To optimize a medical device for intradermal injection, knowledge concerning the thickness~     of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is~     lacking, the investigators will examine the skin thickness (epidermis and dermis) of~     children (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound).~     The investigators hypothesize that they are able to correlate the thickness of the~     (epi)dermis to a specific combination of parameters age, gender, and BMI.~      Based on these results, the investigators can define which needle type and length is needed~     to correctly perform injections into the dermal layer~   "
25176|NCT02727647|"~     Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients~     Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does~     different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough~     bleeding, number of hospital stay and day-off from school? Type Research: Clinical research~      Study design: Single center clinical trials~      Concise methodology:~        1. Study Population: Children with hemophilia A who received treatment at KCMH from May~          2015 to March 2016 will be enrolled in this study. The consent will be obtained before~          the study.~        2. Observation and measurement:~             1. History, interesting clinical data and laboratory data will be recorded in~               Clinical record Form (CRF)~             2. Measurement:~           i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii.~          Number of breakthrough bleedings, number of hospital stay and day-off from school iii.~          Joint score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life~          assessment score~        3. Data analysis: The p-value of less than 0.05 will be considered statistically~          significant. Mann-Whitney test will be used to test correlation of these variables~          (CBC, Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings,~          number of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1,~          EQ-5D-5L quality of life assessment score) Sample size: 16 patients~      Potential impacts:~      The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week~     and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of~     breakthrough bleeding, number of hospital stay, day-off from school, joint health and~     quality of life. The result of this study will guide further study on optimal dose and~     duration of factor VIII treatment of hemophilia A patients in the future.~   "
25177|NCT02727634|"~     The heart is essentially a hydraulic pump which ensures adequate delivery of blood through~     generating pressure and forward flow of blood. The energy delivered by the heart is~     uncommonly measured clinically, and todays gold standard involves placing a plastic catheter~     into the lung arteries. The investigators have developed an ultrasound based approach to~     calculate this energy without the need for catheters through the heart. This novel approach~     is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac~     output and the arterial blood pressure. The study aims to use the ultrasound based approach~     to investigate Cardiac Power in the coronary artery bypass graft population.~   "
25178|NCT02727621|"~     Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the~     depth of sedation and provides analgesia, cardio protection, renal protection, and~     neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor~     agonist that modulates the release of catecholamines from the central and autonomic nervous~     systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are~     calm and cooperative (1). No other sedative agent has this feature, and sedated patients~     frequently awaken in a confused state. Investigators are conducting this study project to~     compare between dexmedetomidine based and propofol based anesthetic techniques with regard~     to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing~     CPB for coronary revascularization.~   "
25179|NCT02727608|"~     This is a dual centre, single arm, exploratory study of the possibility to use eculizumab~     (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the~     islets in patients with diabetics accepted for islet transplant.~   "
25180|NCT02727595|"~     The purpose of the study is to evaluate safety, tolerability and performance of the~     CyclaPlex implant, a button and suture type implant device and instruments for the~     correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus~     deformity.~   "
25181|NCT02727582|"~     Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid~     and rifampin, has been declared a global emergency. Treatment outcomes are poor, driven by~     toxicity and limited efficacy of the 2nd-line anti-TB drugs.~      Although there is evidence that both anti-TB activity and most of the toxicity of the key~     drugs are related to drug exposure, the pharmacokinetic/pharmacodynamic (PK/PD)~     relationships in patients with MDR-TB are poorly characterized. Moreover potential synergy~     of drug combinations has not been identified in the context of MDR-TB, dosing has not taken~     into account the concentrations needed to suppress resistance, and the role of minimum~     inhibitory concentrations (MICs) in dosing is poorly studied.~      There are therefore opportunities to optimize drug doses and combinations to improve~     efficacy, and reduce toxicity. Based on this observational study of patients on standard~     treatment for MDR-TB, our proposal builds on novel methodologies we have developed, largely~     for drug sensitive TB:~        1. The application of computational analytical techniques to tease out the individual~          contributions of anti-TB drugs used in combination~        2. The development of a treatment response biomarker model based on time-to-positivity in~          liquid culture of serial sputum samples.~        3. The in vitro determination of PK targets for anti-TB activity and the suppression of~          resistance using the hollow fiber models of Mycobacterium tuberculosis (Mtb) (HFM-TB).~      Thus the research will enhance our understanding of current modalities of TB treatment,~     while contributing research approaches for future regimen optimization.~      This protocol describes the clinical research component (points 1&2).~      Aim 1: To characterize the effects of 2nd-line drug exposures on treatment response in~     MDR-TB patients. The 2nd-line drugs to be examined are those comprising the standardized~     regimen used in South Africa: kanamycin, pyrazinamide, moxifloxacin, ethionamide and~     terizidone.~      Hypothesis: Amongst patients on standard MDR-TB treatment, variation in drug exposure has a~     quantifiable impact on the rates at which viable Mtb are cleared from the sputum.~      Aim 2: To identify drug exposures associated with the risk of treatment-related toxicities~     in patients on a standard 2nd-line regimen for MDR-TB.~      Hypothesis: The risks of specific toxicities associated with kanamycin, pyrazinamide,~     moxifloxacin, ethionamide and terizidone are linked to drug concentrations.~   "
25182|NCT02727569|"~     This study aims to compare two types of visual field test; retinal sensitivity values~     obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of~     the standard visual field test and with a newly developed test algorithm. The new test is a~     visual field test presented on a flat-panel monitor and has two modes: differential light~     sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion~     Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined~     and compared between the SITA algorithm of the standard visual field test and the new visual~     field test on the flat-panel monitor. The measurement variability of the MMDT will be~     quantified.~      The long-term goal is to reduce test variability below that observed in SITA by 20%, whilst~     producing comparable measurements (contrast threshold values) for comparable test duration.~   "
25183|NCT02727556|"~     In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased~     sensitization, anxiety, and depression scores have been reported in addition to the~     peripheral changes in gastrointestinal tract functions. In this study, investigators will~     evaluate the activity of autonomic nervous system, emotional response, and visual attention~     to food and non-food images in 30 male and female FD patients and 30 age/gender-matched~     healthy volunteers. These data will provide a new finding of the influence of impaired~     cognitive processing of food on symptom generation in functional gastrointestinal disorder~     patients.~   "
25184|NCT02727543|"~     The purpose of this study is to evaluate the impact of the Medisafe smartphone application~     on blood pressure control and self-reported medication adherence for patients with~     uncontrolled blood pressure.~   "
25185|NCT02727530|"~     The main goal of this study is to get to know if applying manual therapy will reduce the~     infant colic symptoms for to improve quality of life of babies and parents.~   "
25186|NCT02727517|"~     This study evaluates the hypothesis that delayed compared to early umbilical cord clamping~     will improve neonatal transition in terms of circulation and breathing during resuscitation.~   "
25188|NCT02727491|"~     With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12)~     undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be~     randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively~     and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and~     volume) at the same time points. The primary outcome is an integrated assessment of~     perioperative pain scores and opioid use for 24 hours postoperatively. Secondary outcomes~     include nausea, vomiting, respiratory depression, and bleeding for 24 hours postoperatively.~     Our hypothesis is that dextromethorphan will decrease the incidence/severity of~     post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid~     consumption and integrated pain scores. This will result in a reduced incidence of~     opioid-related side effects and adverse events.~   "
25189|NCT02727478|"~     This effectiveness-implementation study is a part of the larger study BETA-PD (Balance,~     Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to~     reduce the risk of falling in people with Parkinson's disease (PD) by improving balance,~     gait and physical activity level. The main hypothesis is that highly challenging balance~     training will lead to greater gait and balance ability, increased levels of physical~     activity and an improved health related quality of life. The main aims of the study are to~     evaluate the effectiveness of the HiBalance program in real-life clinical settings, while~     exploring facilitators and barriers for program implementation on a wider scale.~   "
25190|NCT02727465|"~     At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which~     can cause meningitis, blood poisoning and other serious illnesses. Most people carry these~     bacteria and never become ill, yet a very small proportion go on to develop these illnesses~     which can result in life long disabilities or death. The mechanism by which this happens is~     poorly understood and has been studied in various ways, usually focussing on the bacteria or~     on the individual, but none has given a definitive answer. This study will be the first of~     its kind and will assess the interaction between the host and the bacteria at the genetic~     level, through genetic mapping, helping us to understand what makes some people susceptible~     to this infection.~   "
25191|NCT02727452|"~     The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on~     different psychobiological and somatic outcomes of mother and child. The investigators~     compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding~     process.~   "
25192|NCT02727439|"~     It is well recognized that chronic exercise protects against the development of~     cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are~     not well known and not consistent in literature. Acute exertional exercise can induce large,~     transient increases in arterial pressure and development of metabolic acidosis which can be~     associated with pro-inflammatory response involving oxidant stress and circulating cytokines~     known to impair endothelial function.~      The aim of this study is to test the impact of a single exposure to exhausting training on~     microvascular reactivity in healthy sedentary subjects and athletes.~   "
25193|NCT02727426|"~     It is well accepted that high-salt (HS) intake is an essential risk factor in development~     and progression of hypertension. Results of some recent studies suggest that some of the~     deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may~     occur in normotensive individuals and are associated with impaired endothelial function.~     However, the effects of acute salt loading on endothelial function and vascular reactivity~     in young healthy individuals are still scarce and inconsistent.~      The purpose of present study is to determine whether one week of HS intake affects~     microvascular reactivity in young healthy subjects without changes in BP. In addition, the~     investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is~     associated with changes in oxidative stress level and/or with modification of immunological~     response in young healthy subjects.~   "
25194|NCT02727413|"~     The study aims at the comparative examination of pre-, intra- and post-operative release~     profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery~     under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative~     valvular heart disease. Specific attention will focus on the distinction between mediator~     release associated with infection and that resulting from CPB. Concomitantly identification~     and characterization of infectious pathogens in the circulation and in valvular samples will~     be carried out, together with the search for resistance-coding transcripts.~   "
25195|NCT02727400|"~     Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the~     synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg~     quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo~     maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so~     that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the~     oocyte. The goal of this work is to analyze the mitochondrial function and energy production~     in oocyte donors compared with a group of women of advanced maternal age subject to a same~     ovarian stimulation Protocol~   "
25196|NCT02727387|"~     Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy,~     radiotherapy and maintenance therapy.~   "
25197|NCT02727374|"~     Fear to fall has been proven to be a risk factor affecting those geriatric patients who have~     previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy~     and psychological combined intervention, aimed at reducing the fear to fall in the~     aforementioned patients~   "
25198|NCT02727361|"~     Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive~     movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the~     link between genomic mutations and phenotypic expression remains largely unknown.~     Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia,~     particularly the putamen in the pathophysiology of the disease. Experimental results in a~     genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the~     putamen play a critical role in the pathological process of plasticity in the~     cortico-striatal synapse. However, these results have not been demonstrated in humans.~   "
25221|NCT02727062|"~     This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a~     smartphone application) is a feasible and valid tool to assess pain from radiation sores~     (also referred to as mucositis) when treating head and neck cancers with radiation. The~     mobile app will be designed to help people better understand the pain from the radiation~     sores.~   "
25199|NCT02727348|"~     Background:~      Dysautonomia refers to the abnormal function of the autonomic nervous system including~     sympathetic and parasympathetic nervous system. Diabetes mellitus causes secondary~     dysautonomias (1). The Survey of Autonomic Symptoms (SAS) is a simple and validated tool to~     assess the presence and severity of autonomic symptoms (2).~      Diabetic patients also suffer from chronic neuropathic pain. After amputation surgeries, up~     to 78% of these patients may develop post surgical neuropathic pain (3). The self-report~     version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) is~     validated as a diagnostic tool to assess patients with neuropathic pain (4). This scale will~     be used to assess if there is any changes in the pain experienced after diabetic foot~     surgery.~      Currently, both spinal anaesthesia (SAB) and ultrasound guided femoral and sciatic~     peripheral nerve blocks (FSNB) are acceptable anaesthesia for dysautonomic diabetic patients~     with diabetic foot ulcer going for wound debridement, Ray's amputation and below knee~     amputation (5)~      Many studies have compared multiple perioperative parameters of patients undergoing lower~     limb surgery under peripheral nerve blocks versus spinal anaesthesia. These parameters~     include preparation time, anaesthetic complications (e.g. hypotension, nausea and vomiting,~     post-dural puncture headache, urinary retention), patient satisfaction and postoperative~     pain control (6,7,8).~      The investigators want to study if patients with dysautonomia have a different haemodynamic~     response to spinal anaesthesia or peripheral nerve blockade changes compared to patients~     with normal autonomic function.~      Secondarily, the investigators would also study if there is a difference in post operative~     pain control as well as incidence in chronic pain in patients who receive spinal anaesthesia~     versus peripheral nerve blockade.~   "
25200|NCT02727335|"~     Description of clinical and anatomical features and long-term follow-up for patients with~     ALK rearrangement and treated by crizotinib~   "
25201|NCT02727322|"~     The specific aim of this randomized double-blind placebo-controlled trial is to determine if~     extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of~     symptomatic urinary tract infection (UTI) compared with placebo for patients undergoing~     short term indwelling or clean intermittent self-catheterization (CISC) for acute~     postoperative urinary retention following pelvic organ prolapse and/or urinary incontinence~     surgery.~      Consented patients who undergo urogenital surgery and fail their post-operative voiding~     trial will be randomized to either extended release nitrofurantoin 100mg or an identical~     appearing placebo capsule to be taken daily while performing CISC or while indwelling~     catheter is in place. The primary outcome will be symptomatic and culture confirmed UTI~     within six weeks of surgery. Secondary outcomes include adverse events associated with~     nitrofurantoin use, and incidence of nitrofurantoin-resistant isolates from urine culture of~     symptomatic women.~      Primary and secondary outcomes will be evaluated with Student t test and chi squared or~     Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to~     nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05,~     and a 10% dropout rate, we should recruit a total of 154 patients.~   "
25202|NCT02727309|"~     This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in~     treating advanced hepatocellular carcinoma. The primary endpoint is progression-free~     survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.~   "
25203|NCT02727296|"~     To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia~     on the incidence of acute rejection in recipients of living, donation after circulatory~     death (DCD) and donation after brain death (DBD) donor kidneys.~   "
25204|NCT02727283|"~     GSK3179106 is a potent and relatively selective inhibitor of RET kinase which has been~     designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .~      This is a randomized, double-blind (sponsor unblind), placebo-controlled, dose escalating,~     four period, single-dose crossover, first time in human study to assess the safety,~     tolerability and pharmacokinetics of GSK3179106 in normal healthy subjects.~      The study will be composed of 2 cohorts, each having screening (21 days prior to first dose~     of study drug), Treatment, and follow-up periods (7-10 days after their last dose [Day 1 of~     dosing period 4]). The Treatment period will include 4 dosing periods. Subjects will~     participate in either Cohort 1 or Cohort 2. The total duration of the study for each subject~     will be approximately 10 weeks. A sufficient number of healthy subjects will be screened to~     enrol 16 subjects who complete the planned study procedures. Each dosing period will be~     staggered so that only 2 of the 8 subjects will be administered study drug initially. Once~     24 hours (h) have elapsed, and provided there are no safety concerns, the remainder of~     subjects scheduled for that dosing period may be dosed. A review of safety and tolerability~     will occur prior to administration of the next dose level. This same procedure will be~     followed for each escalating dosing period. Subjects assigned to Cohort 1 will participate~     in 1 placebo and 3 dose escalating periods. Subjects assigned to Cohort 2 will participate~     in up to 4 dosing periods which include up to 2 escalating doses and placebo in Periods 1~     and 2, and a pilot food effect in Periods 3 and 4. Within each cohort, subjects will return~     for their next scheduled dosing period approximately 14 days after administration of the~     study drug during the prior dosing period. Cohort 2 will proceed after completion of the~     treatment periods in Cohort 1. Each subject will be enrolled in only one cohort. The planned~     dose range is 10 milligram (mg) to 200 mg in Cohort 1. The actual doses to be administered~     may be adjusted based on safety, tolerability, and pharmacokinetic data at previous dose~     levels; these dose adjustments may involve either an increase or a decrease in the planned~     dose for both Cohorts 1 and 2. There are no formal hypotheses being tested in this study.~   "
25205|NCT02727270|"~     The objective of this study is to evaluate the cortisol awakening response with persons with~     PD and moderate levels of stress as compared to controls and persons with PD and low levels~     of stress. These data are desired so experience can be gained with measuring stress levels~     subjectively and objectively in persons with PD.~   "
25206|NCT02727257|"~     In this study the Investigators explore two questions: if the attentive reaction times~     differs in parkinsonian patients from health controls and if an intensive, focused and~     aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT)~     tailored mainly for motor problems, could have a specific positive effect on multiple~     choices Reaction Times (RTs) as an indirect marker for an effect on attentional-executive~     frontal circuits. The hypothesis is that the MIRT could have a positive effect on the~     top-down control mechanisms, since the continuous feedback given by physiotherapist during~     exercises and the use of cues and devices (such as treadmill plus and stabilometric~     platform), stimulate the selective attention processes that enable goal-directed,~     internally-driven decision, helping the patients to overcome externally-driven decision~     based on stimulus salience and novelty~   "
25207|NCT02727244|"~     This study is aimed to elucidate the association between Pain Catastrophizing Scale Score~     and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.~   "
25218|NCT02727101|"~     The goal of the present study is to evaluate (screen) a large number (12) of different~     dual therapies of perampanel + another AED (PMP+) for a large, 75-100% seizure frequency~     reduction. The design of the study will differ from usual AED studies. The study will be (i)~     open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster~     effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.~   "
25219|NCT02727088|"~     Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50%~     worldwide, probably directly related to the difficulty of the procedure. A successful~     pulpotomy allows the preservation of a vital radicular pulp into the root canal. The~     presence of a biological tissue into the root canal is definitely more efficient than a~     complete filling with an inert material. It has been shown on animal and human studies~     that this pulp stump in contact with the biomaterial is able to regenerate a dentinal plug,~     with the same architecture as physiologic dentin.~      Primary objective : To compare the success rates of root canal treatment (reference) and~     conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature~     teeth.~      Secondary objectives : (1) To describe the clinical and biological prognostic factors of~     these two treatments; (2) to assess the additional value of biomarkers expression levels as~     a prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to~     assess the impact of treatment on post-procedural pain.~      This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over~     endodontic treatment.~      Patients consulting in one of the seven study centers, presenting one of the indications~     retained for the trial and giving written informed consent will receive the treatment~     (endodontic treatment or conservative treatment) allocated by randomization (stratified over~     the clinical diagnosis of the pulp status).~      The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post~     operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to~     evaluate the success or failure of the treatment.~      During the treatment, a sample of pulp tissue will be withdrawn and transferred to a~     molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part~     of the sudy is to assess a putative relationship (1) of regulation of biomarkers expression~     and clinical diagnosis, and (2) of regulation of these biomarkers and success rate of~     pulpotomy.~      Success/failure evaluation:~      The primary endpoint is the time to necessity of endodontic reintervention (analysed as a~     time to failure). This study will use an Intention To Treat analysis as its main assessment~     ; a secondary assessment accounting for peroperative conversions will assess the practical~     impact of these conversions. We will distinguish~        -  Direct failure (means that the failure is directly correlated to the treatment) : the~          reintervention need is due to the evolution of the treated tooth. This includes delayed~          onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular~          radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by~          either pulpal stump or filling material).~        -  Indirect failure (means that the cause of the failure is not directly related to the~          endodontic treatment choice) : any event leading to endodontic reintervention~          indication NOT caused by radicular infection or restoration failure attributable to~          inadequate restoration. For example : new need of post-placement for treatment of loss~          of another tooth, unexpected progression of periodontal disease.~      Both these failure modes are of interest for analysis : the direct failure time is an~     indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure~     time is an indication of its clinical relevance (a good therapy applicable in rare cases may~     be less interesting than a mediocre but widely applicable one).~      Statistical analysis:~      The classical methods of descriptive analysis will be used to describe the raw results.~      In order to make inferences directly on possible clinical results, this study will be~     analyzed in a Bayesian framework.~      This study has been designed in reference with a frequentist demonstration of~     non-inferiority.~      A non-inferiority trial with first and second species error rates α and β has the same~     operational characteristics as a superiority (unilateral trial) of error rates alpha and~     beta, which in turn needs the same study size as a comparison (=bilateral) trial with error~     rates α and 2β.~      The final planned size of the trial is established as follows :~        -  Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according~          to this plan needs 158 patients overall under perfect information assumptions (no~          loss to follow-up, single analysis)~        -  Loss to follow-up : the expected loss to follow-up will cause about 22% of included~          patients to drop out of the study before final analysis this leads to include 194~          patients overall.~      Sequential analysis : since we wish to be able to follow the progress of the study, and to~     interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock~     scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients~     overall.~   "
25220|NCT02727075|"~     This study aims to characterize the diagnostic performance of immunological testing of~     occult gastrointestinal bleeding in stool in the population aged over 75 years with iron~     deficiency anemia.~      As secondary objectives, the study aims to:~        -  determine a threshold of positivity optimizing the immunoassay performance for the~          study population, in accordance with the probabilities of error (false positives, false~          negatives) and weights (defined by expert consensus) allocated to these errors.~        -  Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared~          to a single measure.~   "
25208|NCT02727231|"~     The main objective of this study is to determine whether day and night closed-loop insulin~     delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy~     in adults with type 1 diabetes and HbA1C<7.5%.~      This is an open-label, multi center, randomized, crossover design study, involving a 2-4~     week run-in period, followed by two 4 weeks study periods during which glucose levels will~     be controlled either by an automated day- and night closed-loop system or by subjects usual~     insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed~     subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be~     recruited through diabetes clinics and other established methods in participating centers.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. Subjects will have regular contact with the study team during the home study phase~     including 24/7 telephone support.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM during home stay. Secondary outcomes are time spent with glucose levels above and below~     target, as recorded by CGM, and other CGM-based metrics.~   "
25209|NCT02727218|"~     prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will~     be divided into two groups, the first group will undergo early chest tube removal - after~     three hours, the second group will have late chest tube removal according to the~     department's protocol.~      the study aims to prove the possibility and non inferiority for early chest tube removal for~     thoracoscopic surgeries with non complicated surgical course.~   "
25210|NCT02727205|"~     STUDY TITLE:~      A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat~     Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine~     Transdermal System), 1 mg/24 hr in Healthy Volunteers~      TEST DRUG / INVESTIGATIONAL PRODUCT:~      Rotigotine Transdermal System, 1 mg/24 hr~      INDICATION STUDIED:~      Bioequivalence - Irritation and Sensitization~      STUDY DESIGN:~        -  Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study~        -  One-half (½) of the test patch and one-half (½) of the reference patch was applied~          daily to the same site for each product over a 21 day period followed by a rest phase~          and a challenge phase~   "
25211|NCT02727192|"~     Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with~     prevalence expected to rise significantly the coming decades. The occurrence of AF is~     associated with significantly increased mortality as well as morbidity of which~     cerebrovascular accidents is the most important. Unfortunately treatment options remain~     limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential~     for toxicity and adverse events are recognized. Recent year's catheter ablation of AF~     continues to gain acceptance for symptomatic treatment, but recurrence rate are high with~     need for continuous medication. Thus there is a need to better understand what causes~     development and triggers episodes of AF as well to introduce new treatment options.~     Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore~     gained interest. Many patients with AF have chronic sleep apnea, and in the present study we~     want to explore the interaction between SA and AF. The hypothesis of the present study is~     that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well~     as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis we will~     implant a Reveal device that continuously records the hearts rhythm of 100 patients with~     paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be~     examined, and the patients will then be randomized to treatment of SA or not and the~     influence on total AF burden recorded both before and after ablation.~   "
25212|NCT02727179|"~     This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with~     colorectal liver metastases. Half of participants will be operated on by laparoscopic~     approach and the results obtained will be compared with the results from the other half of~     patients operated on by open approach.~   "
25213|NCT02727166|"~     Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and~     we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of~     a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods.~     Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with~     abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will~     receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A~     gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms~     and gas retention for 3 h) will be performed before and at the end of the intervention~     phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and~     fecal bifidobacteria counts will be measured before and at the end of the intervention.~   "
25214|NCT02727153|"~     Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in~     colonic laparoscopic resections because of faster recovery and less perioperative~     complications.~      Objective. Aim of this study is to assess safety and feasibility of discharging patients~     operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first~     flatus has passed and in the absence of complication-related symptoms.~      Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study~     comparing Ultra to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.~      Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384~     patients were assigned to Ultra E.R.A.S. and 381 to Classic E.R.A.S.~      Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality,~     along with surgical complications, re-operation and readmission rate were recorded and~     compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission~     and re-operation rate.~      Limitations. It is a single center experience; it is not double-blind, with the intrinsic~     risk of intentional or unconscious bias; exclusion criteria because of non compliance may~     be considered arbitrary.~   "
25215|NCT02727140|"~     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit~     of a supportive hatha yoga intervention for patients with hypertension using~     antihypertensive drugs. Patients will be randomized into 3 groups comparing hatha yoga with~     yoga postures, breathing and relaxation techniques to a hatha yoga intervention without yoga~     postures (only breathing and relaxation techniques) as well as to a wait list control group.~   "
25216|NCT02727127|"~     In this project, investigators intend to carry out the first simultaneous, in vivo, imaging~     study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD)~     patients under Lithium therapy.~   "
25222|NCT02727049|"~     The purpose of this research is to:~        1. determine the normal or existing dynamic biomechanics of college athletes and~        2. test the effectiveness of osteopathic manipulative medicine in the treatment of~          athletic injuries.~      Motion capture using Vicon systems allows researchers to quantify characteristics of a body~     such as the range of motion of the hip or shoulder during an athletic technique such as~     kicking or shooting a basketball into the basket. The quantified information has been used~     before to better understand human mobility and performance. Osteopathic manipulative~     medicine (OMM) is manual medicine applied to joints, muscles, and connective tissue with a~     goal of improved body functions. Research demonstrating effectiveness of OMM on the~     musculoskeletal and associated connective tissue systems health includes, among others,~     prospective clinical trials of OMM for treatment of neck pain, low back pain, and acute~     first- and second-degree ankle sprains.~   "
25223|NCT02727036|"~     The purpose of this randomized control trial is to compare the effect of pumpkin seed oil~     2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of~     lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function,~     serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in~     postmenopausal women.~   "
25224|NCT02727023|"~     The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump~     Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to~     measure the canabinomimetic effects of osteopathic treatment.~   "
25225|NCT02727010|"~     Background Women with rare diseases resulting in motor disabilities wishing to become mother~     face a major challenge. The investigators hypothesize that provided with adequate support,~     they are able to achieve a successful pregnancy and to offer their child a safe family~     environment.~      Methods To test this hypothesis, the investigators shall conduct a prospective observational~     prospective survey of a consecutive series of volunteer pregnant women or mothers of~     children less than 14 months, with motor impairment, participating in a program of parenting~     support developed in our institution.~      Primary outcome: social environment, child development, mother-infant attachment, mother-~     infant interactions Secondary outcome: social and demographic characteristics, severity of~     motor impairment, associated impairment, perinatal morbidity for the mother and the infant~     (composite indicator), emotional status, and the needs expressed by women regarding the~     level of medical or social care.~      Analysis The investigators shall describe the distribution of the primary outcome~     measurements in the subgroup of women with motor impairment related to a rare disease. The~     investigators shall compare this distribution to the expected distribution in the general~     population, and to that observed in women with motor impairment unrelated to a rare disease.~     The investigators shall also study primary outcome measurements as a function of the~     severity of maternal disability, of the mother's social characteristics and emotional~     status.~      The investigators shall also describe the distribution the distribution of perinatal~     morbidity globally, and as a function of the potential explanatory variables mentioned~     above.~      The investigators shall also report on the opinion of women regarding the support they were~     offered so far, and the support they declare they should benefit from.~   "
25226|NCT02726997|"~     The goal of this clinical research study is to learn about the safety of giving the~     combination of MEDI4736 (durvalumab), carboplatin, and paclitaxel to patients with~     high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer.~     Researchers also want to learn how the study drug combination may affect DNA and RNA (the~     genetic material in cells) and proteins.~   "
25227|NCT02726984|"~     Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based~     on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition~     of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke.~     Identification of new predictive factor of ipsilateral ischemic stroke in patients with~     carotid plaque could help to screen high risk patients and to guide the treatment. The aim~     of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently~     symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study.~     Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50%~     NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and~     tissue-to-background ratio (TBR) will be measured among carotid plaques.~   "
25228|NCT02726971|"~     This single-center,prospective,randomized,controlled trial is conducted to evaluate the~     efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic~     adhesiolysis in patients with moderate-severe adhesion.~   "
25229|NCT02726958|"~     Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality~     in cardiac surgery. Recently, several authors have reported that increased blood glucose~     (BG) variability could worsen the prognosis in this population.The transcatheter aortic~     valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique~     to aortic valve replacement surgery in high-risk patients.~      The aim of this study is to describe the incidence of stress hyperglycaemia and assess~     whether BG variability could impact the outcome of patients undergoing TAVI.~   "
25230|NCT02726945|"~     This is a pivotal study. The study will examine the safety and efficacy of autologous~     adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device~     for pain, function and stiffness in the knees of osteoarthritic subjects.~   "
25231|NCT02726932|"~     The purpose of this study is to analyze the correlation between intra-abdominal view and~     patient recovery in secondary peritonitis, and to create a new classification based on these~     results. Additionally, a variety of inflammatory markers from blood samples will be~     collected in order to analyze their correlation with patient outcomes.~   "
25232|NCT02726919|"~     The goal of the present study is to obtain pilot data on efficacy and safety of clobazam~     add-on treatment on adults with drug-resistant focal epilepsy.~      This will be an open label study comparing seizure frequency during 12 weeks of baseline~     observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment.~     10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic~     drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks~     patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in~     whom seizure diaries have been kept prospectively prior to study screening visit,~     retrospective baseline will be accepted. Patients will be titrated up to either seizure~     freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not~     be forced. It is anticipated that the majority of subjects will have a 4 week-long titration~     period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.~   "
25233|NCT02726906|"~     The purpose of this study is to examine the effects of modifiable lifestyle factors~     including exercise and healthy living on brain health. The investigators will compare 2~     types of interventions, moderate aerobic walking vs. healthy living education, over 6 months~     to evaluate changes in brain health, cognition, and physical function in older adults with~     cognitive concerns.~   "
25234|NCT02726893|"~     About 30% of patients were reported to suffer inadequate bowel preparation.~   "
25235|NCT02726880|"~     The fifth revision of the Diagnostic and Statistical Manual for Mental Disorders includes in~     its research appendix a potential new diagnosis—Internet gaming disorder. This condition~     primarily affects adolescent boys and young adult men, who rarely seek treatment on their~     own. More often, parents express concerns about their child's game playing behaviors. This~     psychotherapy development study will evaluate feasibility and effect sizes of an~     intervention designed to help parents reduce their child's gaming problems; the intervention~     allows for child participation, but it is geared toward parents, regardless of whether or~     not their child is willing to participate. A total of 40 parents concerned about their~     child's gaming behaviors will complete self and parental report inventories and structured~     diagnostic interviews regarding gaming, substance use and psychosocial functioning. Children~     who elect to participate will complete parallel versions of the instruments. Participants~     will be randomized to a control condition consisting of referral for mental health issues~     and family support services or to a 6-week behavioral intervention designed to assist with~     better monitoring and regulating the child's game playing behaviors. Gaming and other~     problems will be assessed pre-treatment, at the end of treatment and at a 4-month follow-up.~     This study will be the first to evaluate the reliability and validity of a parental version~     of the fifth revision of the Diagnostic and Statistical Manual for Mental Disorders criteria~     for internet gaming disorder in a clinical sample, and it will assess associations of~     internet gaming disorder with substance use, mental health conditions, and family~     functioning as well. This study will be the first randomized trial of an intervention~     designed to assist parents in reducing their child's gaming problems, and results will help~     guide future development of interventions for Internet gaming disorder. To evaluate the~     feasibility and acceptability of this intervention, the proportion of parents assigned to~     the intervention who complete 6 sessions will be examined, as will the proportion of youth~     who attend the sessions. Parent and child ratings of satisfaction with the intervention will~     be assessed. To examine the effect size of the intervention on reducing gaming, parental~     reports of proportion of days on which their child played games and durations of game~     playing will be compared between conditions, controlling for baseline indices.~   "
25236|NCT02726867|"~     The purpose of the study is to evaluate the efficacy and safety of levetiracetam ,~     lacosamide and ketamine treatment of refractory status epilepticus. This will be a~     randomized, open-label, four-arm pilot study comparing time to cessation of refractory~     status epilepticus, determined by continuous EEG monitoring, in patients with refractory~     status epilepticus. Patients with status epilepticus who have been treated with standard~     dose lorazepam (or midazolam) and ≥ 1000 mg phenytoin with documented levels of ≥20 mg/ml~     and continue to have clinical status epilepticus for ≥1-24 hours after phenytoin loading~     will receive intravenously (i.v.) either 4000 mg levetiracetam, 600 mg lacosamide (Group B),~     2.5 mg/kg ketamine or phenobarbital 15 mg/kg phenobarbital (Group D)~   "
25237|NCT02726854|"~     The main research purpose Evaluation of objective response Apatinib second-line treatment of~     advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).~      Objective to study the objective and exploratory secondary research To observe the Apatinib~     in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients~     with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and~     drug safety evaluation, To investigate the relationship of apatinib as second-line treatment~     of advanced pancreatic cancer and the expression of vascular endothelial growth factor~     receptor(VEGFR) in the serum~   "
25238|NCT02726841|"~     Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent~     implantation is superior over standard thoracoabdominal aortic repair.~   "
25239|NCT02726828|"~     this study investigates the analgesic efficacy and other possible effects of ketamine,~     morphine, and both together when administered intrathecally for control of postoperative~     pain following lower abdominal cancer surgeries.~   "
25240|NCT02726815|"~     Primary Objective~      The aim of this research study is to develop a comprehensive inventory of symptoms that~     occur in children with advanced cancer who are receiving a specialist palliative care~     service.~      Secondary Objectives~        -  To assess correlation between parent, child and nurse scores on the Memorial Symptom~          Assessment Scale (MSAS).~        -  To identify symptom prevalence in children with advanced cancer as identified by the~          child/young person (CYP), nurse and parent (to be analysed separately for parent, child~          and nurse).~        -  To identify whether there are any symptoms missing from the age appropriate MSAS as~          identified by the CYP, nurse and parent (to be analysed separately for parent, child~          and nurse).~        -  To identify whether any items on the age appropriate MSAS are not relevant to the~          population being studied (to be analysed separately for parent, child and nurse).~        -  To identify which symptoms cause the most distress as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To identify degree of severity of each symptom as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To identify which symptoms occur most frequently as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To assess the trends between phase of illness and symptom profile, severity and~          distress.~   "
25241|NCT02726802|"~     This study aims to compare the self-report functional outcome measures, medical readiness~     and healthcare utilization (overall cost of imaging, prescription medications for pain, and~     follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical~     therapist versus primary care provider.~   "
25242|NCT02726789|"~     The REP 201 protocol is a small exploratory study assessing the antiviral effects and~     tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks)~     in treatment naive patients or in patients already receiving entecavir and continuing~     entecavir with treatment.~   "
25243|NCT02726776|"~     Suspension syndrome refers to a potentially life-threatening condition that can occur in~     unconscious persons after prolonged suspension in a harness. To date, our understanding of~     the pathophysiology and appropriate treatment is based primarily on case reports and expert~     opinion. The main pathophysiological hypothesis implicates blood pooling in the lower~     extremity and lack of return via muscle pumping. However, a recent French study could not~     support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in~     the pathophysiology of suspension syndrome. The aim of this study is to better understand~     the pathophysiological basis of suspension syndrome and to develop practical recommendations~     for prevention and treatment.~   "
25244|NCT02726763|"~     In this study, the investigators are testing transcranial direct current stimulation (tDCS)~     in breast cancer survivors. In this pilot study, the investigators want to learn if it is~     feasible to use this device in memory rehabilitation.~   "
25245|NCT02726750|"~     The goal of this clinical research study is to find markers that might help predict why some~     patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple~     myeloma (SMM) develop multiple myeloma, while others do not.~      Markers that will be studied may include participant's age, level of proteins in blood and~     urine, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood~     cells, and bone abnormalities.~   "
36924|NCT02573714|"~     The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a~     safe and effective way to help reduce pain in pediatric sickle cell patients with pain~     crises in resource-limited settings.~   "
25247|NCT02726724|"~     The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large~     number of observers. The fear of being judged by others could cause an increased level of~     stress, especially on the junior trainees. Little research has focused on the effect of the~     audience on the level of stress and therefore, on the success rate of complicated procedures~     in neonatal intensive care.~      Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be~     longer with the presence of observers.~   "
25248|NCT02726711|"~     The purpose of this study is to learn more about the regulation of the veins of the abdomen~     by the autonomic (involuntary) nervous system, and how this may affect high blood pressure.~     Normally, the autonomic nervous system controls how much blood flows in the veins. In people~     with high blood pressure, however, the autonomic nervous system is changed. This change may~     affect the way blood flows in the veins of the abdomen which may play a role in their high~     blood pressure. About 32 participants will be screened for the study. The investigators~     estimate 16 will be eligible to participate in all of the study days.~   "
25249|NCT02726698|"~     The purpose of this study is to study clinical factors and (blood) biomarkers related to~     progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with~     special reference to hypercoagulability. All patients will be continuously monitored for~     their atrial rhythm to assess AF progression, either through an implantable loop recorder~     (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both~     in combination with the CareLink home monitoring system. Remote monitoring and interrogation~     will be installed and used on a daily basis.~   "
25250|NCT02726685|"~     The purpose of the research is to investigate the effects of respiratory training on~     respiratory and functional performance in patients with stroke.~   "
25251|NCT02726672|"~     The purpose of this study is to assess the effect of a training of the inspiratory muscles~     against resistance at home during 10 weeks in multiple sclerosis patients with a severe~     disability.~   "
25252|NCT02726659|"~     The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial~     of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II~     postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar~     disorder in the postpartum treatment will receive either a placebo or celecoxib add-on~     treatment. Patients will be monitored regularly to assess psychiatric symptoms and side~     effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib~     in bipolar postpartum depression.~   "
25253|NCT02726646|"~     Summary The aim of this study is to evaluate through clinical, microbiological and~     immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid)~     containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For~     this study, 40 patients will be selected, with an average age between 30 and 59 years old of~     both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba~     Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites~     with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth.~     Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease~     carriers or antibiotics used in the 6 months preceding the study. All patients will receive~     oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival~     sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB +~     DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20~     patients who will receive the following treatments: periodontal debridement ultrasound for~     45 minutes associated with the local administration of 1 mg microspheres containing~     doxycycline, or just mechanical debridement, for each selected site. Will be assessed the~     following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing~     (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical~     Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase~     chain reaction - real time ( real time - PCR) to detect bacteria: Porphyromonas~     gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans~     and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of~     cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α.~     The analysis of the proteolytic enzyme activity is accomplished by using zymography to~     assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90~     days after the initial visit. The results are compared statistically by analysis of variance~     with repeated measures with 5% significance level.~   "
25254|NCT02726633|"~     A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the~     diagnosis of lung cancer.~   "
25255|NCT02726620|"~     The purpose of this study is to determine whether a decision support system can improve the~     adherence to thresholds for low blood pressure by anesthesia providers, which in turn~     prevents their patients from having organ injury.~   "
25256|NCT02726607|"~     The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant~     women before, during and after delivery and evaluate the HITSystem impact on prevention of~     mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0~     intervention will support a range of PMTCT outcomes including retention in care, ART~     adherence, and integration of maternal and pediatric HIV services in low-resource settings.~   "
25257|NCT02726594|"~     The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and~     to measure examination conditions and factors that may affect the image quality and thus the~     diagnostic accuracy. For this purpose a total of 1000 participants enrolled in the study,~     consisting of healthy volunteers (N = 300) as well as patients (N = 700), that are assigned~     to the clinically indicated MRI scan. In this study, individual regions of the body are~     studied by MRI (for example, knee, ankle, head or spine). For all participants of the study,~     the investigation for each region examined is exactly the same except that a single external~     factor is changed or is different. Such variable factors may include: the tube diameter of~     the magnet, weight of the coil, which is closely attached to the examined area of the body,~     the height adjustment of the table on which the participants lie, the duration of the study~     protocol and the generated volume during the investigation. Participants are involuntarily~     subjected to the particular MRI scanner and setting by availability of USZ Radiology~     disposition. For the evaluation of the data, participants will be matched in terms of the~     body regions being examined and based on being part of the patient or subject group. Due to~     the fine different experimental conditions, the influence of these factors on study patient~     comfort, as wells as the image quality and thus the diagnostic accuracy will investigated.~     By this approach, the relevant factors will be examined in isolation. Only by exploring the~     patient's perception/comfort during an MRI scan, the patient-orientated design of the study~     conditions can be improved and thus the possibilities of modern MRI technology can be fully~     utilized in clinical practice.~   "
25258|NCT02726581|"~     This is a phase 3 multicenter, randomized, open label study designed to evaluate the~     clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and~     dexamethasone (N-Pd the investigational arms, when compared to pomalidomide and~     dexamethasone (Pd; the control arm) in subjects with relapsed and refractory multiple~     myeloma (rrMM). The study includes a third arm evaluating the clinical benefit and the~     safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone~     (NE-Pd, the exploratory arm) in the same patient population. Subjects in the control arm~     (Pd) are allowed to cross-over to the exploratory arm (EN-Pd) at the time of progression.~   "
25259|NCT02726568|"~     This trail is to designed to assess the efficacy and safety of high dose Iconitib for NSCLC~     patients harboring EGFR mutation with brain metastases.~   "
25260|NCT02726555|"~     Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein~     cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The~     investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of~     similar lipid-lowering efficacy while was associated with less fatigue than statins. The~     purpose of this study is to evaluate the efficacy and safety of combined therapy with red~     yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular~     disease and who qualified for statin therapy according to national guidelines.~   "
25261|NCT02726542|"~     Fatty liver disease is an increasing problem in overweight and obese adolescents. The~     purpose of this study is to test the effect of growth hormone on liver fat in obese~     adolescents with increased liver fat.~   "
25262|NCT02726529|"~     The purpose of the research is to find out how well a new nutrition program works for~     elementary school students and their families. This program is called Brighter Bites.~     Brighter Bites is a school-based program that teaches students and their parents about the~     importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy~     ways. This project is being carried out at six elementary schools in Houston, Texas. Up to~     600 first grade students and their parents/guardians are expected to join this project.~   "
25263|NCT02726516|"~     Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise~     performance, oxidative stress and muscle damage.~      The hypothesis is that supplementation with PRJ-205 improve aerobic performance~   "
25264|NCT02726503|"~     The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for~     anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of~     the study will be 30 months. All patients will start administration of lenvatinib within 1~     week of enrollment and receive the study drug 24mg orally once daily at almost the same~     time. 1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug~     administration of cycle 1 and administration will be continued until patients meet~     withdrawal criteria. Safety and efficacy assesment will be conducted on a regular basis~     during the trial. Tumor evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks~     and at every 8 weeks after the 16th week since initial administration. When study drug~     administration terminated,tests of the drug termination will be conducted within 7 days of~     withdrawal and final observation will be conducted at 30 days after the last dose. Survival~     survey will be conducted at follow-up term. After the termination of the study drug,~     survival follow up survey will be conducted every 12 weeks unless patients withdraw~     enrollment of this study.~   "
25265|NCT02726490|"~     A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management~     of diabetes in pregnancy.~   "
25266|NCT02726477|"~     The purpose of this study is to assess the efficacy and safety of Wuling San, a traditional~     Chinese medicine, in reducing arm volume excess in women with stage I-II breast cancer~     related unilateral lymphedema.~   "
25267|NCT02726464|"~     This is an observational study that evaluates the characteristics of Platelet Rich Plasma~     used in the therapy and treatment of musculoskeletal injuries and degenerative joint~     diseases.~      A sample of the PRP will be tested for platelet and microparticle content using dynamic~     light scattering to determine if there is a relationship between the composition and the~     treatment outcome.~   "
25268|NCT02726451|"~     The primary objective of this study is to determine the efficacy of Sensi Peel®,~     Rejuvenating Serum, and the C&E Strength Max skin care products in subjects who undergo full~     facial rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in~     improving the appearance of the skin, patient satisfaction with aesthetic appearance, and~     the projected first impressions.~      The secondary objective of this study is to examine patient satisfaction with the continuous~     use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.~   "
25269|NCT02726438|"~     Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How~     fast and completely an antibiotic penetrates into bone is used to determine how effective it~     might be to treat infections related to bones or joints. Since bone has fewer blood vessels~     than other tissue (for example lung tissue or the skin), drugs have a harder time getting~     into them. It is important to find out how much of the antibiotic can get into the bone to~     help patients with bone infections.~   "
25270|NCT02726425|"~     This study evaluates the comparative effectiveness of a diabetes self management (DSM) group~     medical visit in the virtual world (Second life) verses a face-to-face format, aimed to~     increase physical activity and improve glucose control among Black/African American and~     Hispanic women with uncontrolled diabetes mellitus.~   "
25271|NCT02726412|"~     This study aims to describe the postoperative functions of patients with ischaemic lower~     extremities after undergoing revascularisation surgery . Primary endpoints will focus on~     complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to~     the general ward. This include Aldrete scores and other complications that can be~     registrered descriptively. Furthermore, the study seeks to compare the complications~     outcomes between acute and elective revascularisation surgery.~   "
25272|NCT02726399|"~     The purpose of this study is to compare any good and bad effects of using ramucirumab along~     with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab~     alone.~   "
25273|NCT02726386|"~     This is a multi-center, international, open-label, safety study of ND0612, a solution of~     levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in~     subjects with advanced Parkinson's Disease.~   "
25274|NCT02726373|"~     Objective: To compare effects of an intermittent and continuous walking program on walking~     endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover~     prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week~     for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The~     intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week~     detraining period, participants performed the second training condition.~   "
25275|NCT02726360|"~     The purpose of this study is to test a method for analyzing interactions between patients~     and doctors, the Roter Interaction Analysis System (RIAS).~   "
25276|NCT02726347|"~     The study is looking at the pneumonia vaccine and the immune system response to this~     vaccine. The information gathered from this study may be important for your doctor to take~     care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive~     Pulmonary Disease (COPD), or elderly patients. It is important that your immune system~     builds a strong defense to the vaccine so that you are better able to fight a bacterium that~     can cause pneumonia. Some disease prevent the immune system from building a strong defense~     and these patients will not benefit from the vaccine.~   "
25277|NCT02726334|"~     The purpose of this study is to determine the maximum tolerated dose (which will be the dose~     recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of~     movement of the drug within the body, including absorption and distribution) of the study~     drug, BNC101 when administered intravenously as a single agent or in combination with~     chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2~     lines of chemotherapy.~   "
25278|NCT02726321|"~     Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with~     alterations in the sensitivity of carotid and subclavian baroreceptors.~      Aim: The aim of this study is to investigate if carotid IMT is associated with changes in~     the autonomic modulation of the heart rate variability (HRV).~      Methods: This is a prospective cross-sectional study. The carotid IMT is determined by~     B-mode and duplex ultrasonography. The cardiovagal function was determined through linear~     and nonlinear measures of HRV. Linear regression models, adjusted for demographics,~     comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will~     be used to evaluate the association between HRV parameters and carotid IMT.~   "
25279|NCT02726308|"~     Postoperative nausea and vomiting (PONV) are the most common and distressing side effects~     following Laparoscopic cholecystectomy~   "
25280|NCT02726295|"~     Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment~     remains challenging. There exist effective pharmacological therapies for chronic~     constipation, however, many patients do not well respond to current medications. Evidence~     suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic~     constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic~     constipation, there are limited data regarding the efficacy of E.coli Nissle 1917~     (Mutaflor®) in these patients. Therefore, this study aimed to investigate the efficacy of~     E.coli Nissle 1917 (Mutaflor®) in patients with chronic constipation.~   "
25281|NCT02726282|"~     To explore how a clinical sample of patients with thyroid nodules (men and women) with no~     history of thyroid cancer would make decisions about treatments based on different~     terminology used to describe papillary thyroid cancer (with and without the cancer term).~   "
25282|NCT02726269|"~     The goal of this trial is to compare the non-inferiority efficacy and safety of two~     different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg~     once daily (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g~     twice daily (CLA, reference), each during 10 days, over Helicobacter Pylori (HP)~     eradication. Both schemes will be tested in treatment-naive patients, with biopsy-based~     diagnosis for HP infection. One month after finishing each treatment, C13-urea breath~     testing will be required to verify HP eradication. Biopsies will also be taken to identify~     Clarithromycin-resistance mutations in HP strains by fluorescence in situ hybridization~     (FISH).~   "
25283|NCT02726256|"~     The prevalence of type 2 diabetes has consistently increased and type 2 diabetes can cause~     many types of vascular complications. Diabetes develops due to glucose intolerance. Early~     detection and intervention in the stage of glucose intolerance makes it afford to prevent~     overt diabetes and its complications. This study was designed to make a cohort of korean~     patients with glucose intolerance to construct a long term database about clinical~     characteristics of these patients.~   "
25284|NCT02726243|"~     Build a collection of fecal microbiota in order to determine the characteristics of gut~     microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).~   "
25285|NCT02726230|"~     Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and~     child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to~     build front line health worker (FLW) capacities and reach to communities and households, as~     well as to strengthen public health facilities and quality of care to increase maternal and~     neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal~     districts in western and central Bihar.received Ananya, while 30 districts did not. Data~     were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23~     months at 2 year follow-up, from comparable public health blocks in Ananya and Control~     districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal~     health behaviors, and among older infants/toddlers, complementary feeding and vaccination.~     Difference in difference analyses were used to assess Ananya outcome effects in this quasi~     experimental study.~   "
25286|NCT02726217|"~     CareSmarts is a theory-driven behavioral intervention designed to improve self-care among~     patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple~     mediators, including cuing, education, self-efficacy, social support, and health beliefs.~     Individuals will be randomly assigned with equal allocation to either the CareSmarts~     intervention or to usual care for 6 months.~   "
25287|NCT02726204|"~     The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can~     assist task performance during 3D arm movement tasks under various experimental conditions~     in healthy individuals and patients with stroke. This study is designed to test motor~     learning with the robotic rehabilitative device CAREX under three conditions in healthy~     subjects and subjects with post-stroke hemiparesis.~   "
25289|NCT02726178|"~     Background: Inflammation may depress respiration in neonates. The aim of this study was to~     establish a link between post-immunization inflammation and cardio-respiratory events (CRE).~      Methods: Randomized double-blind controlled study of infants born <32 weeks gestation~     receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group~     and a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels~     were assessed before and after immunization. CRE were recorded for 72 hours. Heart rate~     variability (HRV) was assessed by polysomnography.~   "
25290|NCT02726152|"~     The investigators propose a study to compare two methods of closing the stump of the~     appendix during an emergency excision of the appendix using a keyhole approach. One~     similarly designed study has been undertaken in another institution but there were not~     enough patients recruited to the study to allow meaningful conclusions to be drawn.~      Any patient over the age of 16 years whom the investigators suspect to have acute~     appendicitis will be considered for recruitment to the study. During their exploratory~     keyhole surgery, if the surgical team feels that excision of the appendix is indicated then~     the patient will be randomly allocated to either polymer clips or endoloops to the part of~     the procedure where the stump (base) of the appendix is closed.~      The main aim is to determine if polymer clips shorten the duration of the operation. The~     investigators will also determine if there is a difference between the rates of~     complications, the time spent in hospital and the number of times the participants had to be~     readmitted to hospital within 30 days.~   "
25291|NCT02726139|"~     Commercial one and two-stage factor VIII assays may not detect some clinically significant~     inhibitor antibodies. The purpose of the proposed study is to standardize and validate a~     platelet-based factor VIII activity assay with greater sensitivity to clinically important~     inhibitory antibodies. Investigators will evaluate the platelet-dependent inhibitory~     activity vs. conventional inhibitory activity in stored patient plasmas and correlate to~     bleeding histories~   "
25292|NCT02726126|"~     Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level~     lumber laminectomy under general anesthesia were included in this randomized controlled~     double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients~     received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of~     postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative~     monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory~     depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours~     postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative bleeding~     and plasma cortisol (µg / dl) postoperatively were also assessed.~   "
25293|NCT02726113|"~     The study population will be 80 adult men who have been diagnosed with prostate cancer who~     are scheduled to have their prostate surgically removed at either the Medical University of~     South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men~     will be randomized into two groups: one group will take vitamin D3 supplementation and the~     other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of~     the study and again after two months, just prior to the surgical procedure (prostatectomy).~     Prostate tissue will be obtained from the surgical procedure and studied for the effect of~     vitamin D on the prostate cancer cells.~   "
25294|NCT02726100|"~     It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An~     interactive mobile health management system will be developed to support lay family health~     promoters and healthcare staff to improve clinical outcomes for family members with Type 2~     Diabetes Mellitus (T2DM). 2,000 participants from 80 communities will be chosen from an~     urban (Beijing province) and a rural setting (Hebei province).~   "
25295|NCT02726087|"~     This is a single-center, single-blind, all comer, randomized controlled trial. Patients~     scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at Virgen de~     la Victoria Universitary Hospital, Málaga, Spain, will be eligible. Ninety-six patients~     will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients)~     or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of~     0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality~     of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).~   "
25296|NCT02726074|"~     This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of~     perampanel added to monotherapy for partial onset seizures with or without secondarily~     generalized seizures (total seizures).~   "
25297|NCT02726061|"~     The investigators have developed an interactive, multimedia computer-based depression~     treatment program (Dartmouth Research Problem Solving Therapy; DrPST). DrPST is based on an~     evidence-based psychotherapy called Problem Solving Therapy in which depressed patients~     identify problems in their lives and work through a structured format for solving these~     problems. The investigators have subjected DrPST to Phase 1-3 feasibility, acceptability and~     efficacy trials which have been positive and without adverse events. The purpose of the~     current study is to make DrPST available through the Employee Assistance Program (EAP) at~     Dartmouth-Hitchcock Medical Center and the Faculty and Employee Assistance Program (FEAP) at~     Dartmouth College in order to assess the feasibility, acceptability and effectiveness under~     naturalistic conditions.~   "
25298|NCT02726048|"~     This investigation is designed to evaluate the performance, comfort and ease of use of the~     Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy~   "
25299|NCT02726035|"~     The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB)~     in adolescents and adults of normal intelligence.~   "
25300|NCT02726022|"~     Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment~     with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this~     non-interventional, open-label study. The primary aim is to evaluate quality of life~     according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the~     Greek population.~   "
25301|NCT02726009|"~     The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate~     long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced~     hormone-dependent prostate cancer requiring androgen deprivation therapy.~   "
25302|NCT02725996|"~     To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment~     group(Control group)' in patient undergone curative resection(RFA or operation) for~     hepatocellular carcinoma in China.~   "
25305|NCT02725957|"~     This will be a double-blind, randomized, placebo-controlled, single ascending dose study~     performed in healthy subjects.~      The study will include up to four escalating dose cohorts with eight (8) subjects in each~     cohort.~      In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV~     administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).~      All subjects, regardless of their treatment arm assignment, will undergo the same~     evaluations and will receive the study drug at the clinic. Each subject will continue to be~     followed for one week post dosing.~   "
25306|NCT02725944|"~     PROACTIA is a prospective, event-driven observational study. It aims to propose a composite~     scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in~     patients after acute cryptogenic stroke and transient ischemic attack (TIA).~   "
25307|NCT02725931|"~     The aim of this study is to investigate whether providing feedback on physical activity (PA)~     levels to patients with Chronic Obstructive Pulmonary Disease (COPD) is feasible and~     enhances daily PA and health-related outcomes during pulmonary rehabilitation (PR).~      Patients will participate in a 12-week PR program and a PA-focused intervention. Patients'~     daily PA will be monitored during the first (W1), seventh (W7) and 12th (W12) weeks of the~     PR program using the activity monitors GT3X+ (ActiGraph, Pensacola, FL) and feedback will be~     given to them in the following weeks. Each participant will also receive individualised~     recommendations to improve or maintain their PA levels, based on the results of the previous~     week.~      It is expected that, by receiving individualised feedback and goals regarding their PA~     levels during the PR program, patients with COPD will become more active and improve their~     health-related outcomes.~   "
25308|NCT02725918|"~     The study is a prospective, multi-center, open-label, randomized, and controlled phase II~     clinical trial. The investigators hope to figure out the better chemotherapy regimen for the~     post-EGFR-TKI failure setting. The primary objective of this trial is to compare~     progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin~     and single-agent pemetrexed treatment arms.~      The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease~     progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2~     arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed~     (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable~     judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks~     as maintenance until progression or intolerable toxicities. Patients in arm B will receive~     pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.~   "
25309|NCT02725905|"~     Eight U.S. medical schools will be participating in the study: Weight Management Counseling~     in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial~     (RCT) designed to compare the efficacy of two approaches to learning weight management~     counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME).~      The study aims are to refine and compare the efficacy of MME to TE on observed student~     weight management counseling skills measured through the primary outcome, the Objective~     Structured Clinical Examination (OSCE).~   "
25310|NCT02725892|"~     National, prospective, multicentric, non-interventional registry-based study, conducted~     among oncologists, pulmonologists in community and university hospitals, from the public~     sector in Algeria.~      The study will collect information on the characteristics, and lung carcinomas patterns of~     patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.~   "
25311|NCT02725879|"~     Thyroid hormone (TH) and fibroblast growth factor 21 (FGF-21) are reported to share common~     metabolic pathways and underlying mechanisms in terms of energy balance, thus affecting both~     thermogenesis and resting metabolic rate (RMR). Although FGF-21 levels has been studied in~     children and adolescents regarding obesity, body composition and insulin resistance, data in~     children and adolescents diagnosed with Hashimoto's thyroiditis are lacking. Therefore, the~     purpose of this study is to measure the RMR in children and adolescents diagnosed with~     clinical hypothyroidism due to thyroiditis Hashimoto just before starting levothyroxine~     treatment and after six months achieving an euthyroid state, and to detect any association~     between serum FGF-21 levels and RMR.~   "
25312|NCT02725866|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Greece in a clinical~     practice patient population.~   "
25313|NCT02725853|"~     Many people who have had a stroke have problems recovering the use of their affected arm and~     these problems may persist for a long time. The investigators' research will test new ways~     to boost recovery by using non-painful brain stimulation together with training of arm~     movements using basic science principles. The training program will be done using the latest~     technology in rehabilitation such as virtual reality and robotics. The investigators will~     compare three groups of patients who have had a stroke. Each group will receive different~     combinations of brain stimulation and arm training. Another aspect of this proposal is that~     the investigators will do the same training programs in three different countries - Canada,~     Israel and India. In this way, the investigators will combine knowledge and skills to create~     training programs that can be applied anywhere in the world and that are not necessarily~     limited to high-income countries. Also, by combining expertise, the investigators will help~     to build the capacity to do research in India, a middle-income country that has great~     potential to contribute new knowledge to rehabilitation medicine.~   "
25326|NCT02725684|"~     The purpose of this study is to assess whether the use of genomics can help identify patient~     specific treatment choices in cancer. In order to test this, the investigators plan to use~     genomic sequencing technology to identify patient specific mutations in glioblastoma~     multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will~     identify potential treatment targets and whether there are any drugs that could be used for~     these particular mutations. Follow up clinical data will be assessed to see if this~     individualized method of choosing treatment options can improve clinical outcomes in~     patients with GBM.~   "
25314|NCT02725840|"~     Through improved early detection and treatment, the number of long term breast cancer~     survivors continues to increase. There are now 2.8 million breast cancer survivors in the~     U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive~     radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence.~     Even with advanced radiation techniques for dose conformality to minimize exposure of the~     highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical~     pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early~     diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for~     the long term care of these survivors.~      The investigators' goal is to better identify breast cancer patients at high risk for~     experiencing severe pulmonary toxicity requiring medical intervention, provide a means to~     identify toxicity early on, and tailor treatment and/or early intervention on a per-patient~     basis.~   "
25315|NCT02725827|"~     This is a randomized-controlled trial evaluating the effect of the use of hyaluronan~     (HA)-enriched embryo transfer medium on the live birth rate in women undergoing~     frozen-thawed embryo transfer. For half of the women, hyaluonan-enriched medium will be used~     as embryo transfer medium. For the other half of women, control will be used.~   "
25316|NCT02725814|"~     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,~     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for~     reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often~     as it could be to reduce babies' pain. This may be due to lack of certainty about the least~     effective amount of sucrose to use and concerns about the long-term effects of repeated use~     of sucrose on infant development. Factors within the hospital units where babies receive~     care may also influence caregivers' decisions to use sucrose. In this research the~     investigators will conduct two main studies. In the first study the investigators determined~     the lowest amount of sucrose needed to manage babies' pain effectively. In the second study~     the investigators will explore (a) if this amount of sucrose can manage pain when it is used~     repeatedly for all painful procedures while the baby is hospitalized and (b) whether~     consistent use of sucrose influences the development of babies when they are 18 months old.~     During the second study, the investigators will also examine the hospital units where the~     babies receive care. They will look at staff support for research, time and resources and~     other factors that promote and prevent sucrose use. The results of these studies will be~     used to determine the best management of babies' pain during painful procedures in hospitals~     to achieve the best outcomes.~   "
25317|NCT02725801|"~     Appropriate patients undergoing going immediate breast reconstruction with tissue expanders~     following mastectomy will be randomized to receive one-port or two-ports tissue expanders.~     Their clinical course, complications, and outcome will be analyzed.~   "
25318|NCT02725788|"~     A multi-center randomized control trial comparing the dressing wear times of two different~     transparent film dressings when used to secure peripheral intravenous catheters of~     hospitalized adult patients.~   "
25319|NCT02725775|"~     This study is a 10-week intervention study to examine the acute and chronic effects of daily~     intake of a 100 % orange juice drink vs control drink on cognitive performance. The study~     aims to determine if there are any benefits of whole orange juice intake on cognitive~     performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an~     improvement in performance at week 10).~   "
25320|NCT02725762|"~     The purpose of this research study is to determine if photobiomodulation is an effective~     treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the~     disease.~   "
25321|NCT02725749|"~     Objectives: The objective was to compare low level laser therapy (LLLT) therapy versus low~     LLLT therapy in combination with an exercise or exercise only on pain, range of motion~     (ROM), functionality, and activity limitation in patients with subacromial impact syndrome.~      Design: Randomized and placebo-controlled clinical trial.~      Setting: The setting for the study was the Municipal Clinic of Barueri, São Paulo, Brazil.~      Participants: 60 patients with subacromial impact syndrome were randomly assigned in three~     groups.~      Interventions: Group I, experimental (n=21) treated with low level laser therapy and~     exercises; Group II, experimental (n=21) treated with exercises; and Group III, experimental~     (n=18) treated with low level laser therapy. Laser used were GaAs (904 nm, 60 mW), in~     continuous emission. The participants received application of laser three times or week for~     eight weeks, on 9 shoulder points (3 Joules/point) per session.~      Main outcome measures: Visual Analogic Scale (VAS) score, Shoulder Pain and Disability Index~     (SPADI), goniometer, Modified-University of California at Los Angeles Shoulder Rating Scale~     (UCLA), recorded before and after treatment.~   "
25322|NCT02725736|"~     To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of~     calcium channel blockers (Nifedipine) among women with multiple gestation who present with~     threatened preterm labor.~   "
25323|NCT02725723|"~     Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by~     clinicians. Moreover, when using steroidal epidural injections, successful treatment is~     currently defined as the satisfaction of the patient from the treatments, a subjective and~     non-quantifiable indicator.~      In this experiment, the investigators aim to evaluate thermographic images as an objective~     method for assessing the efficacy of steroidal epidural injections, the most common invasive~     treatment for pain associated with spinal stenosis~   "
25324|NCT02725710|"~     This is a randomized controlled double-blind placebo-controlled trial evaluating the impact~     of gabapentin given preoperatively on perioperative pain scores for women receiving uterine~     aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a~     prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the~     abortion setting.~   "
25325|NCT02725697|"~     The purpose of this observational study is to investigate the treatment of complaints~     following sports injuries with Traditional Chinese Medicine by therapists in Switzerland.~   "
25341|NCT02725489|"~     Combining Vigil™ with Durvalumab (MEDI4736) will allow Vigil™ to increase the infiltration~     of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed cell death~     ligand 1) expression. Consequently, the response rate of historically unresponsive PD-L1~     negative cancer to Durvalumab (MEDI4736) will reach a level similar to that achieved in~     PD-L1 positive cancer.~   "
25327|NCT02725671|"~     Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG~     acquisitions. Vectorcardiography has a long tradition in cardiology for providing~     comprehensive information on myocardial function and integrity. In recent years, computer~     assisted analysis has allowed automated interpretation of vectorcardiography with promising~     results in comparison to standard ECG for identifying patients with coronary heart disease.~     This study aims to investigate the utility of cardiogoniometry for noninvasively identifying~     patients who are at risk from coronary heart disease.~   "
25328|NCT02725658|"~     The purpose of this research study is to help us learn if an experimental imaging device~     called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during~     chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the~     end of the treatment. This study will also help us understand the biological reason for how~     DOSI works.~   "
25329|NCT02725645|"~     The purpose of the present study is to analyze the influence of four backpack loading~     conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck~     and lumbar muscles of elementary school children.~   "
25330|NCT02725632|"~     This study is designed to test whether SCN5A mRNA processing is altered in OSA patients,~     which may contribute to their increased arrhythmic risk, and whether processing of SCN5A~     mRNA is modulated by CPAP treatment.~      Specific aims:~        1. Compare sodium channel splicing variants in mild, moderate, or severe OSA patients at~          baseline to at 1 month after CPAP treatment. In addition, the baseline splicing~          variants of SCN5A in the OSA patients will be compared to an age-matched control group.~        2. Hypoxia-associated upstream regulators of SCN5a mRNA splicing, Hypoxia-inducible factor~          1-alpha (HIF-1α), RNA Binding Motif Protein 25 (RBM25) and LUC7-Like 3 Pre-MRNA~          Splicing Factor (LUC7L3), will be examined in OSA patients before and after 1 month of~          CPAP treatment.~   "
25331|NCT02725619|"~     This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus~     Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and~     moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in~     levels of activity/functional connectivity within the neural circuits involved in emotion~     regulation and social perception. Matched typically developing children without autism~     and/or anxiety will be scanned twice, 16 weeks apart, to enable interpretation of~     treatment-evoked change relative to normative development.~   "
25332|NCT02725606|"~     The purpose of the present trial is to evaluate the safety, tolerability and~     pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in~     breast cancer patients. Moreover, the efficacy will be assessed preliminary.~   "
25333|NCT02725593|"~     A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the~     comparative efficacy and safety between dapagliflozin and Placebo~   "
25334|NCT02725580|"~     The proposed clinical trial is the first human, open-label, single dose study of~     self-complementary AAV9 carrying the CLN6 gene delivered one-time intrathecally inserted by~     a lumbar puncture into Batten CLN6 Disease subjects. One cohort of patients with Batten CLN6~     Disease, with confirmed diagnosis, will undergo gene transfer. A minimum of six patients~     will be enrolled into the cohort.~   "
25335|NCT02725567|"~     The purpose of this study is to evaluate the safety of ivacaftor treatment, and PK of~     ivacaftor and metabolites in subjects with cystic fibrosis (CF) who are <24 months of age at~     treatment initiation and have a CF transmembrane conductance regulator (CFTR) gene gating~     mutation~   "
25336|NCT02725554|"~     The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve~     Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo~     System utilizes a minimally invasive procedure to implant a neurostimulator. This technology~     includes an octopolar electrode array stimulator with an embedded receiver. The energy~     source is a small, external, rechargeable transmitter, which is worn by the patient. The~     StimRelieve Halo System eliminates the implantable pulse generator, which has been the most~     common reason for reoperation or discomfort with existing devices.~      For this study, all subjects will be randomized at enrollment into either a delayed or~     immediate continuation group. The immediate continuation group will immediately continue~     with the stimulation therapy after the 30-day trial period and will be monitored for a total~     of 12 months. The delayed activation group will have their device turned off after the~     30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated~     and the delayed activation group will have their devices reactivated.~      All subjects will immediately receive the permanent stimulator(s). The permanent stimulators~     can easily be removed if non-responders are identified. The wireless technology eliminates~     the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome~     is highly dependent on placement of the stimulators. By eliminating the need for a staged~     trial, infection rates and incidence of pocket pain will decrease.~      In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness.~     Immediate activation of all devices will be done in the post-op period based on sensory~     response and subject comfort. Subjects will be seen at 14-days post-implant to assess~     patient compliance with the device, assess clinical response and to adjust programming~     parameters if not responding. Subjects will be seen at 1 month post-implant and headache~     diaries and questionnaires will be reviewed. Subjects not responding to the therapy by at~     least a 30% reduction in headache days will be deemed non-responders and will be withdrawn~     from the study and can choose to have the device removed. After the trial period, all~     responders will follow their random assignment determined at enrollment (delayed or~     immediate continuation). All subjects will be monitored for a total of 13 months. Adverse~     events will be monitored throughout the study.~   "
25337|NCT02725541|"~     This is an open label, neoadjuvant phase II study to evaluate the objective response,~     toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed~     HER2-equivocal breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be~     intravenously administered every 3 weeks for a total of 6 weeks. Patients who achieve a~     partial or complete response after the 6-week treatment (responders) will continue on~     trastuzumab emtansine for an additional 12 weeks.~   "
25338|NCT02725528|"~     This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both~     the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus~     limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in~     terms of improved quality of life and reducing recurrence of the disease without serious~     complications. Since collagenase injections are costly it is also important to know if this~     novel intervention is cost-effective from the patient, Ministry of Health and societal~     perspectives.~   "
25339|NCT02725515|"~     The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus~     Erythematosus (SLE) disease activity improvement achieved by a brief course of~     disease-suppressing steroid therapy~   "
25340|NCT02725502|"~     Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting~     in insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors~     (DPP4 inhibitors e.g. linagliptin & sitagliptin) has been used for type 2 diabetes mellitus~     (T2DM) traditionally. Previous studies has shown that it is also effective in type 1~     diabetes mellitus (T1DM), but the mechanism of action not well understood. This study will~     evaluate possible mechanism of action of linagliptin in T1DM patients.~   "
25343|NCT02725463|"~     Although cochlear implants can restore hearing to individuals who have lost cochlear hair~     cell function, there is no adequately effective treatment for individuals suffering chronic~     imbalance, postural instability and unsteady vision due to loss of vestibular hair cell~     function. Preclinical studies have demonstrated that electrical stimulation of the~     vestibular nerve via a chronically implanted multichannel vestibular prosthesis can~     partially restore vestibular reflexes that maintain steady posture and vision. This pilot~     clinical feasibility study of a multichannel vestibular implant system will evaluate this~     approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin~     ototoxicity or other causes of inner ear dysfunction.~   "
25344|NCT02725450|"~     The main purpose of this study is to ascertain whether the application of Motor Imagery~     together with normal practice improves fine motor skills in disabled individuals.~   "
25345|NCT02725437|"~     The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability,~     and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one~     of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.~   "
25346|NCT02725424|"~     This is a randomized,phase II,open-label study, The purpose of this study is to determine~     the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer~     according to their Her-2 expression status.~      The primary endpoint of this study: pathology response rate the second endpoints of this~     study:pathology complete response rate R0 resection rate Progression-free survival ( PFS)~     Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse~     event(AE)~   "
25347|NCT02725411|"~     This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5~     mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary~     objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg~     administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the~     long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7~     administrations).~   "
25348|NCT02725398|"~     Gastrointestinal cancer has developed into a serious health problem in China. 80%-90%~     patients were detected at middle and later stage. The five-year survival rate for advanced~     cancer patients is less than 10%. The main reason of the bad clinical diagnosis and~     treatment is that the present technical method is difficult to achieve early diagnosis.~     Endoscopy with biopsy is still the main method for confirming gastrointestinal cancer. But~     it is limited to identify early tumors and it leads to the low diagnostic rate of early~     tumors and the poor overall therapeutic effect.~      Confocal laser endoscopy (CLE) can obtain pathologic information of lesion in real time and~     improve the diagnostic rate of early tumors. Probe-based confocal laser endomicroscopy(pCLE)~     is a new technology recently. Since its laser probe is applicable to all conventional~     endoscopes, pCLE greatly increased its clinical application. However, gastrointestinal~     motility has greatly influence on pCLE imaging quality and inspection effect owing to the~     poor stability of the small probe manipulation. Scopolamine (654-2, in China) is clinically~     used to inhibit bowel peristalsis, but its effect is still not ideal and its side effects~     are common.~   "
25349|NCT02725385|"~     This research trial studies stress and coping in caregivers of younger patients with cancer.~     Learning how caregivers of children with cancer experience and cope with chronic stress may~     help to develop effective programs for reducing caregiver stress.~   "
25350|NCT02725372|"~     Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety,~     tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in~     symptomatic subjects with pulmonary arterial hypertension (PAH).~   "
25351|NCT02725359|"~     Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human~     body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain~     and discomfort for the patients.~      a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to~     their hypotensive effect, a2-agonists are also used in anesthetic practice for their~     sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle~     relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of~     spasticity and has recently been used to treat musculoskeletal pain conditions.~      Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary~     advancement to improve success and safety of regional anesthesia. Analgesic effect of US~     guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has~     not been reported yet.~      The aim of this study was to evaluate the analgesic effect of preemptive oral single dose~     tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The~     investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores,~     analgesic consumption, analgesic related side effects.~   "
25352|NCT02725346|"~     A computer-assisted solution for acromioplasty is presented. The software allows surgeons to~     better plan the surgical procedure by visualizing dynamic simulation of the patient's~     shoulder joint during everyday activities. Impingements are dynamically detected and the~     exact location and amount of bone to be resected is precisely computed. As a result, the~     success of the acromioplasty does not only rely on the surgeon's experience or previous~     recommendations, but on quantitative data. Although the clinical validation of this 3D~     planning support is currently under evaluation, it may allow to recover more effectively~     postoperative joint mobility, to get a better relationship with pain and a better healing~     rate of the rotator cuff tendons.~   "
25353|NCT02725333|"~     Background: There is no evidence that shoulder stabilization effectively corrects the~     glenohumeral translation in unstable shoulders, explaining residual apprehension in certain~     patients. The purpose of this study was to analyze the effect of surgical stabilization on~     glenohumeral translation.~      Methods: Anteroposterior and superoinferior translations were assessed in patients, before~     and after shoulder stabilization, through a dedicated patient-specific measurement technique~     based on optical motion capture and computed tomography.~   "
25381|NCT02724943|"~     A systems approach emphasizes the linkage between individual behavior change strategies and~     social and physical environmental changes, which act synergistically to facilitate (or~     inhibit) healthy eating and active living. The hypothesis of this study is that among~     low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems~     approach to child obesity will reduce body mass index (BMI) compared to primary prevention~     alone.~   "
25354|NCT02725320|"~     The overall purpose of this work is to use a prospective cohort study to examine~     patient-specific but shoulder-extrinsic factors and how they influence the results of~     rotator cuff surgery. There are undoubtedly many factors that play a role in patient~     outcome, however, this project will focus on three: the effect of gender on outcome, the~     effect of mood disorders and coping style on outcome, and the effect of patient height and~     reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have~     a significant influence over outcomes.~   "
25355|NCT02725307|"~     This study evaluates a novel noninvasive method to dynamically monitor the effect of~     percutaneous transluminal angioplasty on arterial pulse wave~   "
25356|NCT02725294|"~     This observational study will examine the care-seeking behaviors of Veterans with chronic~     obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or~     lack of access to care leads to delays in getting care for COPD exacerbations. Participants~     will complete a baseline in-person visit and receive calls every two weeks for one year to~     monitor for COPD exacerbations. Detailed information about each exacerbation and time to~     care will be obtained. A sample of participants and their caregivers will participate in~     more in-depth interviews. Approximately half the participants will also use a remote inhaler~     monitor to record their albuterol inhaler use to see if this approach can identify early~     exacerbations. Results from this study will be used to develop an intervention that will~     assist Veterans in the early identification, evaluation, and treatment of exacerbations, and~     will be integrated with the VA primary care team.~   "
25357|NCT02725281|"~     Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL)~     non-pharmacological methods used for reducing the level of the pain and anxiety among the~     patients with the urinary stones are not sufficient and the effectiveness of these methods~     is controversial. There are very few studies, which investigated the effects of music on the~     pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use~     of stress ball for relaxation and distraction on the reduction of pain and anxiety during~     lithotripsy has not been found in the relevant literature. Investigators also evaluated that~     further evidence-based studies are necessary. Thus, investigators aimed to investigate the~     effectiveness of stress ball and music for reducing the pain and anxiety of the patients~     during ESWL in this study.~   "
25358|NCT02725268|"~     The primary purpose of this study is to determine if MLN0128 in combination with weekly~     paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.~   "
25359|NCT02725255|"~     Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due~     to IPs is greatest in school-age children who typically have the highest burden of~     infection. In 2001, WHO passed a resolution for the use of large-scale mass drug~     administration (MDA) of antihelminthic drugs to deworm children in developing countries.~     Though initially effective, there is concern that MDA might not be sustainable over extended~     periods especially considering the large children populations and the high frequency of~     dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a~     circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs.~     There is hence a need for alternatives that are not only affordable and sustainable but~     easier to implement in the long term with a minimal chance of development of resistance. The~     investigators propose to develop and test the feasibility of a corn porridge meal fortified~     with papaya fruit extracts that have been shown to have antihelminthic properties. The~     investigators intend to evaluate its efficacy when given through school feeding programs and~     compare the outcome with albendazole- the recommended MDA agent for deworming school~     children. The investigators will design and formulate the product and test it among children~     in three primary schools in Western Kenya.~   "
25360|NCT02725242|"~     This study will evaluate the efficacy of Once-daily Formoterol/Budesonide Turbuhaler 4.5/160~     µg in the period of step down in well controlled asthmatic patient.~   "
25361|NCT02725229|"~     the objective of the present study was to compare the efficacy of TENS and parasternal block~     with local anesthetic infiltration in relieving pain during the first 24 h period following~     median sternotomy.~   "
25362|NCT02725203|"~     A two-armed, cluster randomized controlled trial will be conducted comparing the Activate~     intervention with care as usual in 31 general practices in the Netherlands, in which~     approximately 300 patients at risk for cardiovascular disease will participate. The Activate~     intervention focuses on increasing physical activity and is developed using the Behavior~     Change Wheel (BCW). The activate intervention consists of four nurse-led consultations~     divided over a 3-months period. Primary outcome is the level of physical activity measured~     with an accelerometer. Potential effect modifiers are age, body mass index, level of~     education, social support, depression, patient-provider relationship and baseline amount of~     minutes of physical activity. Data will be collected at baseline, at 3 months and at 6~     months of follow up.~      Nurses will be trained in delivering the intervention by a one-day training and coaching~     sessions supervised. A process evaluation will be conducted.~   "
25363|NCT02725190|"~     The purpose of this study is to assess the impact of sleep deprivation on subjective~     inspiratory endurance in healthy subjects.~   "
25364|NCT02725177|"~     Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with~     active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)~   "
25365|NCT02725164|"~     Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx~     during airway surgery. Investigators sought to measure the concentrations of anesthetic~     gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and~     uncuffed tracheal tubes during spontaneous and controlled ventilation.~   "
25366|NCT02725151|"~     Known before diagnosed heart failure and used diuretic therapy patients will be admitted in~     this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be~     used for management of Acute Heart failure therapy. And investigators will calculation~     correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers~     will not interfere to standard recommended treatment protocol, researchers will correlated~     the urine amount and changed vital signs with therapy with Vena cava inferior diameter.~   "
25367|NCT02725138|"~     We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in~     the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in~     this double blind, placebo controlled, randomized trial.~   "
25368|NCT02725125|"~     This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or~     refractory stomach cancer with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor~     cells that express the EPCAM protein on the cell surface.The study will determine if these~     modified T cells help the body's immune system eliminate tumor cells.The trial will also~     study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body~     and the impact of this treatment on survival.~   "
25369|NCT02725112|"~     This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6~     sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence)~     healthy male and female subjects who, at the time of screening, are between the ages of 18~     and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be~     replaced at the Sponsor's discretion. Screening activities will be completed within~     approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6~     treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6~     periods with subjects receiving single doses of pregabalin ER 330 mg target release rate~     tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release~     rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet,~     and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study~     treatments will be administered following a 600- 750 calorie, 30% fat evening meal.~   "
25370|NCT02725099|"~     To examine chewing versus traditional oral administration of ticagrelor in ST-elevation~     Myocardial Infarction (STEMI) patients on platelet reactivity.~   "
25371|NCT02725086|"~     A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare~     Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of~     Leucostim® and Neupogen® in Healthy Adult Volunteers~   "
25372|NCT02725073|"~     To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer~     and a flexible laser probe in locally advanced hilar cholangiocarcinoma.~   "
25373|NCT02725060|"~     The purpose of this study is to see if some people with postural tachycardia syndrome (POTS)~     have higher levels of immune proteins (autoantibodies) directed against receptors of the~     autonomic nervous system, and if these autoantibodies make a difference in their POTS~     symptoms. The investigators also want to see if the levels of these autoantibodies stay the~     same over time.~   "
25374|NCT02725047|"~     The purpose of this study is to verify the effect of cryotherapy in pain control, function~     and quality of life in individuals with knee osteoarthritis.~   "
25375|NCT02725034|"~     The purpose of this study is to assess whether high definition endoscopy with Optic~     Enhancement can reduce the biopsy number needed per patient for the detection of gastric~     intestinal metaplasia without the loss of corresponding diagnostic yield~   "
25376|NCT02725021|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents~     in 7-11th grade of secondary school. The primary endpoint is the change in smoking~     prevalence between the two groups.~   "
25377|NCT02725008|"~     Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the~     pediatric emergency department.~   "
25378|NCT02724995|"~     This study will help the investigator understand the pathogenesis of different rare genetic~     conditions and to establish database of rare genetic databases. This would ultimately help~     to provide more accurate diagnosis through advanced genomic diagnostic testing and databases~     established from this study. This knowledge would in turn help in the clinical management of~     other affected family members and other individuals affected with similar conditions.~     Understanding of pathogenesis of the disease would also enable the investigator to develop~     targeted therapies for rare genetic diseases, and also to collaborate on the targeted~     therapy-related clinical trials.~      The investigator plans to store the results of this study in databases. These results will~     be shared with other researchers or doctors, who research, diagnose or treat the individuals~     with similar diseases.~      The investigator will only share the data that is collected and not the biological samples.~   "
25379|NCT02724982|"~     Body image satisfaction and self- esteem level are important to be known among students in~     order to intervene in a correct time. Body dissatisfaction is one of the factors leading to~     negative self-perception, low mood, depression, and eating disorders. This may be~     detrimental to students in their academic performance. However, the correlations of body~     image satisfaction towards body mass index and self- esteem among university female students~     are still unclear in Malaysia. Thus, the purpose of this study is to determine its~     relationships among Chinese female students. university female participants will be included~     with convenience sampling method. Participants will completed Ronsenberg Self- Esteem Scale~     and 8 items version of Body Shape Questionnaire. These 2 scales used to measure level of~     self- esteem and body image satisfaction. Body mass index will be calculated from self-~     reported height and weight. The data will be analysed by using descriptive and correlation~     methods.~   "
25380|NCT02724969|"~     The purpose of this pilot randomized trial is to determine the effectiveness, feasibility,~     and acceptability of a mobile, semi-automated text message-based intervention (MILK) to~     prevent perceived low or insufficient milk supply (PIM) in a population of mothers without~     prior breastfeeding experience. PIM is the leading cause of premature breastfeeding~     cessation, and prior work has shown that it is often rooted in low breastfeeding~     self-efficacy and misconceptions about lactation physiology and trajectory. The MILK~     intervention is designed to address PIM, as well as other common breastfeeding problems via~     semi-automated text messages of prenatal and postpartum breastfeeding education and support.~     Messages are time-sensitive (e.g., specific to gestational age, time since delivery) and~     based on the Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled~     from pilot work that investigated how first-time mothers view, manage and describe~     breastfeeding problems. Messages were vetted with experts in clinical lactation, as well as~     pregnant and postpartum women with no other children.~      The MILK intervention will be trialed against a control intervention group, who will receive~     more general perinatal education through the national Text4Baby system. The investigators~     will recruit approximately 115 healthy, pregnant women at 13-25 weeks gestation from Magee~     Women's Hospital clinics and outpatient sites. Women will be randomized via~     computer-generated simple randomization to the experimental or control intervention. Both~     groups will receive text messages 3-5 times per week from week 25 of pregnancy through week~     8 postpartum. Measured outcomes of interest will include perceived breast milk supply,~     breastfeeding confidence, maternal anxiety, breastfeeding exclusivity, and breastfeeding~     duration. Data will be collected at baseline (13-25 gestational weeks), 34-36 gestational~     weeks, and at 1, 2, 4, and 8 weeks postpartum via online survey (Qualtrics) or telephone~     call. To assess the potential longer-term impact of the intervention, breastfeeding~     continuation and exclusivity will be reassessed via telephone at 6 months postpartum.~     Between group and group x time differences in outcome measures will be examined graphically~     and via linear mixed modeling. To inform modifications to MILK, telephone interviews will be~     conducted with a subset of participants in each group to assess and compare intervention~     use, burdens and challenges, and suggested alterations (8 weeks).~   "
25382|NCT02724930|"~     This study will test the effectiveness of using enhanced facilitation strategies on~     implementation of an automated Interactive Voice Response (IVR) system as a means to~     remotely deliver in-home self-management support to Veterans with chronic pain. The~     implementation intervention uses an enhanced facilitation approach paired with automated~     case finding and direct patient outreach to encourage uptake of Cooperative Pain Education~     and Self-management (COPES). A nested effectiveness study will measure pre-post differences~     in pain-relevant outcomes (pain intensity, physical functioning and physical activity). The~     investigators will use a stepped wedge cluster design in which clusters will be randomized~     to the timing of the introduction of enhanced COPES implementation. Investigators will~     assess the efficacy of the facilitation based implementation strategy by evaluating COPES~     uptake in the implementation settings.~   "
25383|NCT02724917|"~     The purpose of this study in patients with schizophrenia is to evaluate the safety,~     tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with~     placebo when administered as repeated daily oral doses.~   "
25384|NCT02724904|"~     This research study is assessing the feasibility of reduced intensity allogeneic~     hematopoietic stem cell transplantation (HSCT) as a possible treatment for relapsed /~     refractory non-Hodgkin lymphoma involving the central nervous system (CNS). HSCT is the~     transplantation of stem cells, usually derived from bone marrow, peripheral blood, or~     umbilical cord blood.~   "
25385|NCT02724891|"~     Patient-reported outcomes are commonly used in healthcare. Examples include validated~     symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and~     Reconstructive Surgery there are many questionnaires and diaries that have been validated~     for a paper-based administration. As technology is incorporated into delivery of medical~     care and research, investigators need to consider how to collect data electronically while~     ensuring that this new format is equivalent to the paper questionnaires they rely on. In~     this study, the investigators aim to validate a series of validated questionnaires and~     symptom diaries administered via the web and smartphone for a more streamlined care for the~     patients.~   "
25386|NCT02724878|"~     This research study is studying the combination of Atezolizumab and Bevacizumab as a~     possible treatment for Advanced Non-Clear Cell Kidney Cancer.~   "
25387|NCT02724865|"~     Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires~     lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due~     to longer life expectancy and increase in weight in the general population, its prevalence~     is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral~     appliance at present time. Different oral appliances are available, but most used is the~     mandibular advancement device (MAD). This study focuses on two different types of MAD: the~     classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron~     bar to regulate the open space; and the Somnodent, which consists of two separate splints,~     fixed on the mandible and the maxilla, but has no iron bar attached.~   "
25388|NCT02724852|"~     This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in~     HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both~     groups who had no protective antibodies to at least one of the three viruses.~   "
25389|NCT02724839|"~     The purpose of this study is to design, pilot, and tweak a series of peer-led group~     nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese~     and who want to eat healthier and be more active.~   "
25390|NCT02724826|"~     A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning~     pain intensity, treatment expectations, disability, neck movements and quality of life in~     subjects with non-specific, long-term NP after three and twelve months.~   "
25391|NCT02724813|"~     Stroke results in long-term disability for many people, and particularly for survivors of~     stroke who have cognitive impairments. However, a decreasing proportion of stroke patients~     are able to access or receive publicly funded rehabilitation. The investigators have shown~     in previous studies that in-person delivery of the Cognitive Orientation to daily~     Occupational Performance (CO-OP) rehabilitation approach to promoting attainment of everyday~     life goals has resulted in improvements in functional independence and executive function.~     In a small pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI)~     (n=3), the investigators found the delivery method was feasible and that participants were~     satisfied with the treatment and demonstrated clinically significant improvements on~     personally meaningful activities. The investigators will investigate the feasibility,~     preliminary efficacy, and cost-effectiveness of delivering CO-OP in an online format to~     reduce disability post-stroke. The study design is a single-blind (assessor), randomized~     wait-list control trial with a one-month retention follow-up. All therapy and testing~     sessions will be delivered online. We hypothesize that participants will demonstrate~     improvement in everyday activities and community participation.~   "
25392|NCT02724800|"~     The purpose of this study is to directly compare the effectiveness of two interventions for~     insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy~     for Insomnia (CBTI).~   "
25393|NCT02724787|"~     Impulsive aggression (IA) is common among Veterans with posttraumatic stress disorder~     (PTSD), and PTSD is one of the most prevalent post deployment mental health conditions~     affecting Afghanistan and Iraq Veterans. An inability to manage one's emotions (emotion~     dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD~     evidence-based psychotherapies are two critical missions for the Veterans Health~     Administration.~      This research supports these missions by providing a 3-session emotion regulation training~     (Manage Emotions to Reduce Aggression) to Veterans in order to teach them how to manage~     emotions and prepare for PTSD treatment. This is an open trail, so all Veterans who meet the~     inclusion criteria will be allowed to receive the treatment. Each Veteran's level of~     aggression and emotion dysregulation will be measured at the beginning and end to the~     treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel~     equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and~     ultimately recover from PTSD.~   "
25421|NCT02724423|"~     This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects~     will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and~     will be based on the subject's body weight.~   "
25394|NCT02724774|"~     Treating mothers' perinatal depressive and other mental health symptoms alone does not~     prevent impaired parenting quality and adverse infant outcomes. The goal of this research is~     to conduct a randomized controlled trial to evaluate the effectiveness of adding a~     research-based 10-week home visiting parenting program to evidence-based mental health~     treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and~     infant development. Participants will be English and Spanish-speaking low-income mothers who~     began publicly funded mental/behavioral health treatment in pregnancy at their primary care~     community health centers.~   "
25395|NCT02724761|"~     Our double-blinded, randomized control trial will assess the effect of nebulized racemic~     epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.~     The investigators have had success in managing post-operative dysphagia in patients~     undergoing ACDF with the administration of this drug. Half of the participants will review~     nebulized epinephrine. The other half will receive placebo.~   "
25396|NCT02724748|"~     The aim of this study is to generate and investigate the clinical effectiveness of an~     educational intervention for staff to prevent and manage patient challenging behaviour.~   "
25397|NCT02724735|"~     All subjects completing the randomized treatment period in Protocol NS2014-1 will~     discontinue study drug and be asked to provide consent to be followed in this 6-month study,~     at their final safety visit. The study will consist of an enrollment visit, followed by~     bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.~   "
25398|NCT02724722|"~     Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present~     in the public and easily contacted by children through air, foods, and skin. This study aims~     to examine whether the use of family-based behavior intervention by providing simple flyers~     plus face-to-face health education point-by-point and give one bag containing stainless~     steel-made tableware for eating out use to study children's mothers or main-care givers can~     significantly decrease melamine and phthalates exposure by measuring urinary melamine and~     metabolites of phthalates (especially DEHP metabolites) in study children and their mothers~     or main-care givers, when compared to those provided simple flyers only.~   "
25399|NCT02724709|"~     The progress in surgery of the aortic root and the evolution of transcatheter aortic valve~     replacement as an alternative to surgical treatment in selected patients have refocused the~     need for quantitative imaging of the aortic root during transcatheter aortic valve~     replacement and valve-sparing aortic root surgery. In this study, we aim to assess the~     ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version,~     Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical~     normal aortic valve and root, who are indicated for both 3D transesophageal echocardiography~     (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale.~     Measures of the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and~     the ability of the semi-automated 3D TEE modeling software is tested. Given the workflow~     advantages of automation, this 3D TEE approach may enhance the clinical adoption of routine~     3-dimensional imaging beyond CT.~   "
25400|NCT02724696|"~     RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the~     objective of territorial coverage by regional expert centers and systematic discussion of~     patients management at national tumor board.~   "
25401|NCT02724683|"~     The purpose of this study is to determine whether drainage with the usage of a fine,~     patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and~     effective method in the management of symptomatic malignant ascites. Complications' rate of~     the procedure and patients' quality of life, nutritional status and experience on the~     treatment are main endpoints.~   "
25402|NCT02724670|"~     MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with~     prostate carcinoma.~   "
25403|NCT02724657|"~     To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of~     asthmatic children with mouth breathing.~   "
25404|NCT02724644|"~     The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the~     treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as~     Cellulite).~   "
25405|NCT02724631|"~     This is the first of three planned phases designed to evaluate the feasibility and~     tolerability of TubeClear® to restore patency in occluded Pediatric Enteral Access Devices.~     Based on preliminary data obtained from this phase of the study, subsequent phases will~     continue to evaluate feasibility and tolerability (Phase IIA) and ultimately compare~     efficacy of TubeClear® to the Children's Hospital of Philadelphia (CHOP) Standard Treatment~     to restore patency in occluded Pediatric Enteral Access Devices (EAD) (Phase IIB).~   "
25406|NCT02724618|"~     There is a growing body of evidence exploring the role of curcumin as a radioprotector~     against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor~     cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate~     cancer patients undergoing radiotherapy.~   "
25407|NCT02724605|"~     The aim of the study is to detect if the storage duration of red blood cells has impact on~     some biochemical parameters after intra operative transfusion in pediatric trauma patient~   "
25408|NCT02724592|"~     Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries.~     Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early~     carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect~     of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.~      Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second~     permanent molars at eruption will be allocated in this randomized, controlled, single~     blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.~   "
25422|NCT02724410|"~     To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy~     on complication rates and resource utilization following appendectomy for perforated~     appendicitis~   "
25436|NCT02724228|"~     This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety,~     Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective~     is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in~     children with ACH who have completed two years of treatment in the 111-202 study.~   "
25409|NCT02724579|"~     This phase II trial studies how well reduced doses of radiation therapy to the brain and~     spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of~     brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using~     chemotherapy and radiation therapy have been shown to be effective in treating patients with~     WNT-driven medulloblastoma. However, there is a concern about the late side effects of~     treatment, such as learning difficulties, lower amounts of hormones, or other problems in~     performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill~     cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine~     sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor~     cells and may also reduce the late side effects of treatment.~   "
25410|NCT02724566|"~     Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a~     glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in~     healthy overweighed volunteers has been previously assessed in a phase I clinical trial~     (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof~     of concept to the population targeted by future innovative insulin-sensitizing therapies:~     patients living with type 2 diabetes.~   "
25411|NCT02724553|"~     Previous studies attempted to understand the dysphotopsia phenomenon by examining~     intraocular lens type, anterior capsule depth, iris-to-lens depth, lens refractive material,~     clear cornea incision wounds and anterior capsulorrhexis. However, there is limited~     literature in understanding haptic orientation and negative dysphotopsia; postulated~     theories and anecdotal reports relate to horizontal haptic orientation and the~     lateralization of rays such that light is received both in smaller width and anterior to the~     peripheral retina; however, no formal studies currently exist.~   "
25412|NCT02724540|"~     The primary aim of this trial is to estimate the duration of hepatic progression-free~     survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial~     Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary~     hypothesis is that chemoembolization will be nearly twice as durable as bland embolization;~     thatis, the hazard ratio for HPFS will be 1.76 or better.~   "
25413|NCT02724527|"~     Cavosonstat (N91115) is being studied as a potential novel therapy for cystic fibrosis (CF),~     and this study assesses a target population of patients who are heterozygous for~     F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D,~     G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R).~   "
25414|NCT02724514|"~     Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy.~     Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been~     studied. At present, no objective and standardized tools exist to evaluate breast~     lymphedema.~      The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance~     to determine if it is possible to measure the extent of the fluid in the breast.~   "
25415|NCT02724501|"~     This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial~     cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed~     world. The studies in this program span the spectrum from fruit flies to humans, as part of~     a synergistic partnership that will significantly enhance our understanding of the molecular~     genetic events involved in the development and progression of endometrial cancer. The~     discovery of new targets for therapy, and the ability to evaluate these in subsequent~     clinical trials is a significant strength of this scientific interaction, which may result~     in cures for patients with primary and relapse endometrial cancer and prevention of this~     cancer in women who are at high risk.~   "
25416|NCT02724488|"~     Two part prospective study to:~        1. investigate the feasibility of performing ultra-deep sequencing of plasma derived~          circulating tumor DNA (ctDNA) in individual patients with advanced solid tumors who are~          currently being treated with immune checkpoint inhibitors (ICIs) and~        2. obtain fresh tumor biopsies and serial blood samples to investigate the clonal~          evolution of tumors under the selection pressure of ICIs.~   "
25417|NCT02724475|"~     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second~     most-common cause of cancer mortality. Liver resection is the first-line curative treatment~     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from~     25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and~     advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no~     effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in~     eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray~     (γ-knife) can also be used to treat patients with PVTT. But there still lack of~     evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view~     of this, we aim to implement a randomized controlled study to find out an effective~     treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on~     evidence-based research.~   "
25418|NCT02724462|"~     The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides~     higher quit rates than the current standard smoking cessation app.~   "
25419|NCT02724449|"~     The purpose of this study is to obtain information concerning the safety and effective use~     of a protective barrier film in patients experiencing severe incontinence associated~     dermatitis.~   "
25420|NCT02724436|"~     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second~     most-common cause of cancer mortality. Liver resection is the first-line curative treatment~     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from~     25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the~     unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure~     beta-emitter, without any toxic effect or immune rejection. There are ample data that~     support the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our~     study was to compare the clinical outcome of radioembolization with Y-90 and TACE and~     provide a new strategy for the treatment of intermediate and advanced hepatocellular~     carcinoma with portal vein thrombus by conduting a randomized trial.~   "
25423|NCT02724397|"~     Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging~     systems used in endoscopy which are recently developed. BLI was developed to compensate for~     the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the~     detailed visualization of both the microstructure and microvasculature. However, BLI still~     is not able to obtain sufficient brightness for distant lesions. The newly developed LCI~     system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength~     narrow-band laser light combined with white laser light on the basis of BLI technology. LCI~     makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize~     a slight difference in color of the mucosa. This is a study to determine if using LCI of the~     colon, rather than the usual white light on the colon, will improve the detection of flat~     adenomas and serrated polyps. The polyps are called serrated because of their appearance~     under the microscope after they have been removed. They tend to be located up high in the~     colon, far away from the rectum. They have been definitely shown to be a type of~     precancerous polyp and it is possible that using LCI will make it easier to see them, as~     they can be quite difficult to see with standard white light. LCI/BLI enables endoscopists~     to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and~     LCI/BLI, it will show if there is any comparable advantage to using one or the other for~     lesion detection and assessment.~   "
25424|NCT02724384|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of using~     electrical plasma to treat toenail fungus.~   "
25425|NCT02724371|"~     The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size~     Ultra High Profile (UHP-L) Breast Implants.~   "
25426|NCT02724358|"~     In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a~     randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE~     on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high~     expression of Notch1.~   "
25427|NCT02724345|"~     To evaluate and analyse the clinical effect and application value of postoperative adjuvant~     TACE treatment in patients with different expression levels of CK18 using randomized~     controlled study and provide evidence for the necessity of postoperative adjuvant TACE.~   "
25428|NCT02724332|"~     To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with~     overexpression of ASPH after radical surgery using randomized controlled study and provide a~     new anti-recurrence treatment for HCC patients after operation.~   "
25429|NCT02724319|"~     It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many~     patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies~     have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key~     determinant of clopidogrel metabolism, contribute to these findings. Prasugrel and~     ticagrelor are alternative agents whose effectiveness is not dependent on CYP2C19 genotype.~     A boxed warning on the Food and Drug Administration (FDA)-approved clopidogrel labeling~     warns of reduced effectiveness in patients with the LOF genotype and recommends alternative~     therapies in these patients. The availability of an assay recently approved by the FDA,~     SpartanRX, which provides results within one-hour facilitates performing genetic testing as~     a clinical test in real-world practice. We therefore propose to 1) examine the feasibility~     of implementing CYP2C19 genotyping using SpartanRX as standard of care for patients~     undergoing cardiac catheterization at UF Health Jacksonville providing the opportunity for~     clinicians to embrace genotype-guided antiplatelet therapy in those who proceed to PCI and~     2) determine if CYP2C19 genotype-guided antiplatelet therapy reduces the risk for major~     adverse cardiovascular outcomes after PCI.~   "
25430|NCT02724306|"~     The present study will use a randomised controlled trial design to investigate whether~     moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk~     markers associated with the development of bowel cancer in individuals previously diagnosed~     with a bowel polyp. The study will also investigate the effects of the programme on~     long-term exercise behaviour and changes in psychological variables. A selected sample will~     also be part of individual interviews at baseline and 12 months to gauge narrative accounts~     of personal, psychological and sociological beliefs surrounding participation in physical~     activity. The findings of this study might inform better practices for the prevention of~     bowel cancer in high risk populations.~      After a screening colonoscopy, eligible participants will be randomised to either an active~     lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered~     supervised exercise sessions and motivational interviewing for 6 months. Intervention~     components will cease after 6 months, but participants will be followed-up at 12 months to~     investigate maintenance to physical activity over the long-term. The SC will not be offered~     the intervention until the end of the study. Participants in both groups will be invited for~     assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body~     composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social~     variables.~   "
25431|NCT02724293|"~     This study compares analgesic efficacy, and safety of three different doses of~     peri-operative pregabaline to placebo following radical cystectomy.~   "
25432|NCT02724280|"~     H. pylori infection plays a very important role in gastric carcinogenesis, progressing from~     chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally~     cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the~     basis of endoscopic findings. Histology is currently considered to be the gold standard for~     detecting H. pylori infection. The reliability of detecting H. pylori infection~     histologically depends on the site, number, and size of gastric biopsy specimens. The blind~     biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling~     errors. Most studies conclude that as well as on expertise in staining and visualizing the~     bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy~     sampling, and neither the original nor the revised version of the Sydney system reliably~     identifies more than half the cases in patients with confirmed gastric atrophy.~   "
25433|NCT02724267|"~     The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of~     individual therapy using randomized controlled study, in order to acquire the evidence of~     evidence-based medicine and create a new program of targeted internal radiation therapy in~     advanced HCC patients.~   "
25439|NCT02724189|"~     This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online~     pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp~     assessment in comparison to standard practice of a nurse led face to face assessment. The~     investigators will also assess the acceptability of MyPreOp amongst patient participants and~     staff participants.~   "
25440|NCT02724176|"~     Papillary thyroid cancer (PTC) is the most common subtype of thyroid cancer.~      The most common site of PTC nodal metastases is the central neck, which has a reported rate~     of lymph node metastases as high as 50%~70%.~      Central neck dissection has important value to ensure accurate clinical staging and surgical~     planning.~      As a novel lymphatic tracer, carbon nanoparticles (CN) have been applied successfully in the~     detection of sentinel lymph nodes in breast and gastric cancers, while not been used as a~     lymphatic tracer for PTC. The goal of this study was to evaluate whether the use of CN~     facilitates the detection of lymph nodes, increases the number of metastatic lymph nodes~     removed, accurately reflects the metastatic condition of the central neck, and has the~     potential to protect the parathyroid glands.~   "
25441|NCT02724163|"~     The main purpose of this study is :~        1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3~          doses) is tolerated and can be safety delivered in combination with cytarabine plus~          mitoxantrone or liposomal daunorubicin in induction~        2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin~          (anthracycline) & cytarabine as induction therapy.~        3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of~          doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined~          with induction chemotherapy.~        4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine~          & cytarabine (FLA) in standard risk patients.~        5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant~          (HSCT) conditioning regimens of different intensity: conventional myeloablative~          conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning~          (RIC) with fludarabine/busulfan.~   "
25442|NCT02724150|"~     Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low~     in the management of acute peptic ulcer bleeding~   "
25443|NCT02724137|"~     The purpose of this study is to:~        1. Determine whether the Physical Therapy (PT) & Fitbit® intervention should proceed to a~          full-scale clinical trial. This decision will be based on three hypotheses: Treatment~          promise (Hypothesis 1A): People in the PT & Fitbit® will walk 1250 more steps/day and~          spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control~          at discharge and at 6 months, Safety (Hypothesis 1B): < 5% will have adverse events~          because of the intervention, Recruitment (Hypothesis 1C): 75 recruited, 90% to complete~          trial, and 85% complete visit at 6 months.~        2. To evaluate the short- and long-term adherence of the PT & Fitbit® intervention.~          Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT& Fitbit® group will~          wear the Fitbit® and participate in goal setting and behavioral counseling while in PT.~          Long-term Adherence (Hypothesis 2B): 75% of PT & Fitbit® will wear the Fitbit® at 6~          months.~        3. To quantify changes in potential underlying mechanisms for increased physical activity.~          Hypothesis 3: Change in self-efficacy for physical activity, walking endurance and~          participation in daily activities will be associated with improvements in physical~          activity.~   "
25444|NCT02724124|"~     The purpose of this study is analyze the effects of static stretching and active warm up,~     isolated and associated, in functional performance of the lower limbs in college volleyball~     athletes.~      Study hypothesis:~      H0: The stretching and / or warm up, alone or in combination, do not alter the functional~     performance of volleyball players.~      H1: The stretching and / or warm up, alone or in combination, alter the functional~     performance of volleyball players.~   "
25445|NCT02724111|"~     The investigators aim to investigate operating conditions, postoperative recovery and~     overall satisfaction of surgeons between deep neuromuscular blockade (NMB) group and~     restricted NMB group during spinal surgery under general anesthesia. The investigators~     hypothesize that this study can present good surgical conditions, postoperative recovery~     outcomes and overall satisfaction of surgeons in deep NMB group, thereby proving the~     advantages of deep NMB as well as flaws of restricted NMB in spine surgeries.~   "
25446|NCT02724098|"~     The aim of this study is to investigate the pharmacokinetics of subcutaneously administered~     dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously~     administered dexmedetomidine will be calculated. In addition, the investigators will report~     the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels,~     vital signs such as systemic blood pressure, heart rate and sedation. The investigators will~     also monitor the local and systemic safety and tolerability of subcutaneously administered~     dexmedetomidine.~   "
25447|NCT02724085|"~     This is a single-center, randomized, placebo-controlled, double-blind,~     single-ascending-dose, inpatient study to assess the safety, tolerability, and~     pharmacokinetics of TP‑271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the~     inclusion/exclusion criteria will be enrolled in this study.~   "
25448|NCT02724072|"~     The study will assess the effectiveness and safety of the Thoraflex™ Hybrid Device in the~     treatment of aortic disease affecting the aortic arch and the descending aorta, with or~     without involvement of ascending aorta.~      The study will also assess safety and early clinical outcomes in patients who receive an~     extension procedure within 1 year of Thoraflex™ Hybrid Device implantation.~      Lastly the study will assess the safety and clinical outcomes of patients who receive a~     Thoraflex™ Hybrid Device for treatment of a ruptured aorta.~      Patients will be followed for 3 years.~      The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1~     year post-procedure.~   "
25449|NCT02724059|"~     The study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic~     CT either there was a known lung malignancy (for staging purpose) or not (for diagnosing~     purpose).~      All patients will undergo to EBUS-guided TBNA. Elastography will be performed on all lymph~     nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures~     will be performed if EBUS-guided TBNA doesn't provide representative material.~   "
37414|NCT02567318|"~     The purpose of this prospective study is to investigate the degree of association between~     the volume of important pain-relevant structures in the brain and the size of the areas of~     secondary hyperalgesia.~   "
25450|NCT02724046|"~     This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the~     contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic.~     One third of enrolled villages will receive standard care; in one-third of villages,~     household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin;~     and in one-third of villages, the entire village will be offered a single dose of oral~     ciprofloxacin after the notification of the first case in the village.~   "
25451|NCT02724033|"~     The investigators would like to compare the therapeutic and cost effectiveness of~     established therapies for postoperative nausea and vomiting to regional nerve blocks of the~     head and neck area an intervention known for analgesia but for which the antiemetic effects~     hasn't been entirely explored.~      The rational is based on the knowledge of the anatomical innervation of the inner ear and~     the role of the parasympathetic nervous system in the emetic act. A lot of focus has been~     given on its counterpart the sympathetic nervous system and its role in painful conditions.~     The investigators believe that the nerve blockade of the parasympathetic innervation can~     have some beneficial effect in the post-surgical patient.~   "
25452|NCT02724020|"~     This study will evaluate the efficacy and safety of single-agent MLN0128 and the combination~     of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with~     metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular~     endothelial growth factor (VEGF)-targeted therapy.~   "
25453|NCT02724007|"~     The aim of this study is to validate international versions of the International~     Classification of Disease Injury Severity Score (ICISS) in adult trauma patients admitted to~     four public university hospitals in urban India.~   "
25454|NCT02723994|"~     This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent~     chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the~     study will optimize the dose of study drug (ruxolitinib) in combination with the~     chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and~     ruxolitinib at the recommended dose determined in Part 1.~   "
25455|NCT02723981|"~     Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate~        -  the incidence of bleedings (COSTA-Bleed) and~        -  the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with~          the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with~          short-term single antiplatelet therapy as compared to a guidelines-based strategy in~          patients with coronary artery disease with an indication for chronic oral anticoagulant~          therapy.~   "
25456|NCT02723968|"~     Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose~     prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring~     relies on oral glucose tolerance test . However, this test is neither sensitive nor~     specific.~      The aim of this study is to compare sensitivity and specificity of different methods for GM~     monitoring in children and adolescents with CF.~      Continuous GM system (CGMS) will be used as the reference method. Results will be compared~     to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT),~     homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model~     assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin~     A1C). Patients will be classified into three groups according to CGMS: normal glucose~     tolerance, impaired glucose tolerance and diabetes mellitus.~   "
25457|NCT02723955|"~     GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody~     intended for the treatment of cancers of different histology. This is a first-time-in-human~     (FTIH), open-label. multicenter study designed to investigate the safety, pharmacology, and~     preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the~     aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy~     and in combination with pembrolizumab or other immune therapies. The study is comprised of~     two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A~     as dose escalation phase and Part 1B as dose expansion phase; Part 2: GSK3359609 combination~     therapy with Part 2A dose escalation phase and Part 2B dose expansion phase. Each part and~     phase of the study includes a screening period, a treatment period, and a follow-up period.~     The primary objective of the study is to determine the safety, tolerability, maximum~     tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.~   "
25458|NCT02723942|"~     The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell~     immunotherapy for GPC3 positive hepatocellular carcinoma.~   "
25459|NCT02723929|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and~     functional limitations in people with osteoarthritis of the knee. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
25460|NCT02723916|"~     High quality and effective parenting in the preschool years is connected with long term~     positive child behavior and mental health outcomes. The purpose of the study, Parent~     Training in Pediatric Primary Care: A Self-directed Tablet-based Approach, is to test the~     outcomes and implementation of a tablet-based parent training program in Pediatric Primary~     Care. Testing and evaluating the implementation of digitally delivered programs is important~     to increase the ease, reach, sustainability, and integration of mental health prevention~     into primary care settings.~   "
25461|NCT02723903|"~     A comparative study is conducted on the patients with suspected coronary artery disease~     (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS)~     survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized~     Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score~     and coronary angiography result. The efficacy, sensitivity and specificity of the SSS~     checklist will be evaluated during following up.~   "
25462|NCT02723890|"~     To investigate the efficacy and safety of using the novel Tyto device for remote physical~     examination by co-investigators as compared to a standard medical physical examination by~     physicians.~   "
25463|NCT02723877|"~     This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation~     followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics~     of PQR309 in combination with standard dose of eribulin in patients with locally advanced or~     metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion~     part).~   "
25464|NCT02723864|"~     Background:~      The drug cisplatin treats certain cancers when given with other chemotherapy drugs.~     Researchers think combining cisplatin with 2 other drugs could block proteins that support~     cancer cell growth. The other drugs are ABT-888 (veliparib) and VX-970. They want to test if~     this drug combination slows the growth of cancer and is safe.~      Objectives:~      To test the safety and tolerability of VX-970 and veliparib combined with cisplatin in~     people with advanced refractory solid tumors. To determine the maximum tolerated dose of~     these drugs.~      Eligibility:~      People ages 18 and older with:~        -  Solid tumors that have progressed after treatment or for which no treatment exists~        -  Normal organ and marrow function~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  CT scan or MRI~        -  Blood and urine tests~      Participants will get the study drugs in 3-week cycles:~        -  Cisplatin in a vein on 1 or 2 days~        -  VX-970 in a vein on 2 days~        -  Veliparib by mouth twice a day on 6 days~      In each cycle, participants will have 5 physical exams and blood tests 5 times.~      In some cycles, participants will have CT scans or MRIs.~      In cycle 1, participants may have 2 tumor biopsies. A small piece of tissue is removed by~     needle.~      Participants will keep a study diary. They will write when they take the drugs and if they~     have side effects.~      Participants will stay in the study as long as they tolerate the drugs and their tumors are~     not getting worse.~      Participants will have a phone call about a month after their last dose.~   "
25465|NCT02723851|"~     Acute Myocardial Infarction (MI) is still the leading cause of death in the western world.~     Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In~     average it takes between 2-3 hours from the beginning of the chest pain. The damage to the~     heart in these 2 hours is critical and often irreversible. Thus an early warning test or~     device is highly warranted.~      Corsens has developed a noninvasive device using several sensors applied to the chest and a~     detection system able to recognize the ischemic origin of chest pain. This clinical study is~     intended for evaluating the safety and efficacy of the Corsens technology while use for~     myocardial infarction detection~   "
25466|NCT02723838|"~     The purpose of this study is to investigate the safety and efficacy of intratumoral~     REOLYSIN® therapy alone and in combination with standard neoadjuvant gemcitabine and~     cisplatin in muscle-invasive bladder cancer.~   "
25467|NCT02723825|"~     Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis~     injury, because of the complex damage mechanism and often leads to growth retardation and~     joint deformity, the patient's physical and mental damage larger; also epiphysis injury~     restoration requires higher standard and more difficult to fixed, and methods are being~     actively explored to improve the curative effect and prevent the sequelae. Our hospital~     pediatric department of orthopedics expects to conduct prospective study through multi~     center to study the influence of factors such as the tibia epiphysis fracture of distal~     injury's mechanism and initial and residual displacement and treatment etc. on patients'~     prognosis of late growth disorders, joint deformity and ankle function.~      Methods and analysis: To join the multi center research collaboration group of the south~     pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan~     Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's~     Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital,~     Guangzhou city women and children's Medical Center), the formation of multi center research~     network, writing program, including the inclusion and exclusion criteria, grouping and~     follow-up time, method. Participating in the working group meeting, listening to the~     expert's opinions to improve research programs, formulate the tracking table of distal~     tibial epiphyseal fracture, and starting to implement after approved by the medical ethics~     committee of each hospital. The hospital is responsible for supervision in the whole process~     of project implementation, and building the real-time reporting system, and it is the~     responsible person of pediatric department of orthopedics of Foshan Hospital of TCM to do~     the random inspection. After the completion of data collection, data entry and statistical~     analysis conducted by the pediatric department of orthopedics in Foshan Hospital of TCM.~      Ethics and promotion: The research is approved by the hospital medical ethics committee of~     the south pediatric orthopedics multi center cooperative research group. Single blind method~     is performed for children in the course of the study. Research data is shared by all~     participating units and joints promotion of research results.~      Registration: To register and update the study on the United States NIH ClinicalTrials.gov~     website.~   "
25468|NCT02723812|"~     An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal~     influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3~     years old~   "
25469|NCT02723799|"~     This study aims to:~      I. Develop and pilot test the effectiveness of a Hope Promotion Program compared with the~     standard treatment protocol, in hope, comfort and quality of life, based on a population of~     palliative patients followed at Oncology day care unit.~      II. Evaluate perceptions and acceptability of Hope Promotion Program among palliative~     patients submitted to the intervention program.~   "
25470|NCT02723786|"~     This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics~     of GSK1070806 in subjects undergoing renal transplantation. GSK1070806 is an~     anti-interleukin 18 (IL18) monoclonal antibody, which binds to IL-18 and inhibits signaling~     through the IL-18 receptor. Recipients of donor kidneys, retrieved after circulatory death~     of the donor, will be administered a single intravenous infusion of GSK1070806 to test~     whether inhibition of IL-18 can reduce the rate of Delayed Graft Function (DGF) and graft~     rejection. Subjects will be followed for 12 months post dose/transplant. Up to 40 adult~     subjects will be enrolled in this study.~   "
25471|NCT02723773|"~     The purpose of this study is a long-term follow-up of the two studies 110390 and 113077~     (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK~     Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2~     additional doses in two subgroups of older adults.~   "
25472|NCT02723760|"~     This is an open-label SPECT/CT (single photon emission computed tomography/computed~     tomography) study to investigate the diagnosis and efficacy evaluation performance of~     99mTc-3PRGD2 in rheumatoid arthritis patients. A single dose of nearly 11.1 MBq/kg body~     weight of 99mTc-3PRGD2 (≤20µg 3PRGD2) will be intravenously injected into the patients.~     Visual and semiquantitative method will be used to assess the whole-body planar and lesions~     section SPECT/CT images. Adverse events will also be observed in the patients.~   "
25473|NCT02723747|"~     The purpose of this study is to validate a full-automated post-processing software for~     quantitative perfusion of the myocardium with magnetic resonance imaging.~   "
25506|NCT02723318|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on cognition using the Patient Reported Outcomes Measurement Information System~     (PROMIS) Cognition Short form 8a.~   "
25510|NCT02723266|"~     The purpose of this study is to modify an existing Reproductive Health intervention for~     adolescents with diabetes for Gestational Diabetes and make it culturally appropriate~     American Indian/Alaska Native adolescents. The intervention will then be evaluated for~     effectiveness in AI/AN female teens at risk for GDM.~   "
25474|NCT02723734|"~     The primary purpose of this study is to determine whether a tumor test recently developed by~     GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same~     accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher®~     test was developed from samples derived mainly from men of European origins and little is~     known about its performance in AAM. It is important to study whether this test can be used~     in AAM who are known to experience the highest rates of prostate cancer as well as death~     from prostate cancer. The use of the Decipher® test result to predict how well a patient~     will do before treatment may make it possible for doctors to distinguish aggressive disease~     from low risk prostate cancer and modify treatment accordingly. Thus, patients that do not~     need additional therapies may be spared from unnecessary side effects and those that are at~     risk may be provided with more aggressive therapy to improve survival. This study is being~     done to learn whether the Decipher test can really affect these outcomes.~   "
25475|NCT02723721|"~     Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma~     cells, limited to the epidermis. It is found most commonly on the head and neck of elderly~     persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop~     into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm~     margin. However, the lesions can be large, and conventional surgery can be difficult,~     particularly on the face.~      Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate~     (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis~     and superficial dermis.~      Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or~     a prolonged remission of non-invasive LM.~      Because of the exploratory phase of this study (no case report and no clinical trial at the~     early phase of designing this study, only one case report at the time of submission of this~     form) the investigators will conduct an open label study limited to patients who are not~     eligible to, or who refuse surgical treatment of their LM.~      The main objective of this study is to determine the proportion of patients with complete~     response (CR) obtained 2 months after one or two cycles (for patients who did not respond to~     the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head~     and neck).~   "
25476|NCT02723708|"~     The purpose of this study is to see if a non-medication intervention can increase motivation~     in individuals with ADHD by observing brain activity using magnetic resonance imaging (MRI).~   "
25477|NCT02723695|"~     The cochlear implant is an electrical hearing aid that restores the perception of~     surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery,~     the labyrinthine break necessary for insertion into the cochlea of the implantable part may~     cause a malfunction of the vestibular system which can induce dizziness, balance and~     perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic~     interactions could alter the balance control and the visual and postural spatial orientation~     perceptions.~      The usual treatment includes the monitoring of the patient's quality of life, of the~     vestibular function and of hearing. This study adds an assessment of spatial orientation and~     of posture.~   "
25478|NCT02723682|"~     A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility~     of implementing a 24-hour urine collection as part of NHANES in 2014.~   "
25479|NCT02723669|"~     This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets~     (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label,~     Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.~   "
25480|NCT02723656|"~     This is a population-based randomized controlled trial of 600 patients with a diagnosis of~     cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that~     will inform critical questions regarding the relative efficacy of care coordination options,~     the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will~     react to proactive tobacco related communications. Investigators will compare the reach and~     efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm~     1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm~     randomized design at two urban cancer centers, and will explore cancer survivor attitudes~     and preferences about proactive tobacco treatment.~   "
25481|NCT02723643|"~     The incidence and prevalence of hypertension is increasing while the controlled rate is~     extremely low in China. A substantial percentage of participants with uncontrolled~     hypertension are correctable if potential associated factors are identified and corrected.~     Therefore, it is clinically relevant to investigate and identify these potential associated~     factors of uncontrolled hypertension so as to increase controlled rate and reduce~     hypertension-associated health and economic burdens in the future. Investigators plan to~     conduct a prospective registry study in a single-center to initially investigate the~     potential associated factors of uncontrolled hypertension in cardiovascular outpatient~     department. Furthermore, investigators plan to evaluate the effects of potential associated~     factors correction on hypertension controlled rate and cardiovascular outcomes.~   "
25482|NCT02723630|"~     This will be a randomized, single dose, open-label, three-treatment period crossover study~     in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the~     level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.~   "
25483|NCT02723617|"~     The objective of this study is to evaluate the effects of different quantities of lean beef~     (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context~     of a modified Mediterranean dietary pattern that is representative of foods typically~     consumed in the United States.~   "
25484|NCT02723604|"~     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser~     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients~     receiving combined modality therapy consisting of chemotherapy and radiation therapy for~     head and neck cancer.~   "
25485|NCT02723591|"~     This study will compare the incidence of a two-part composite endpoint consisting of de novo~     donor specific antibody formation or a designation of immune activation  on peripheral~     blood molecular profiling in patients maintained on twice daily, immediate-release~     tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.~   "
25486|NCT02723578|"~     Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase,~     dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the~     folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural~     mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies~     showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal~     cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the~     treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer~     cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and~     gefitinib in preclinical study.~      In this multicenter, non randomized, open label phase II study, investigators aimed to~     evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.~   "
25487|NCT02723565|"~     The transition to unassisted breathing after invasive ventilation often proves challenging,~     with over 40% of patients failing their first attempt of unassisted breathing. Persistent~     ventilator dependence predisposes patients to nosocomial complications and increases the~     economic burden of critical illness. Ventilator-dependence results from an imbalance between~     the load and capacity of the respiratory muscle pump. Patients who fail a trial of~     spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced~     pulmonary edema, atelectasis or dynamic hyperinflation. Many patients who are dependent on~     the ventilator also show a striking loss of pump capacity due to diaphragm dysfunction.~     Though each of these mechanisms respond to specific interventions, it is often difficult for~     physicians to discern which mechanisms are at play at the bedside. Bedside ultrasound is a~     potentially useful means of evaluating cardiac, pulmonary and diaphragm function during~     weaning failure. It is readily available, highly feasible and already widely employed in~     clinical practice. As yet, no study has evaluated the accuracy and feasibility of combining~     echocardiography with lung and diaphragm ultrasound to comprehensively evaluate the~     physiological mechanisms of weaning failure. The objectives of this study are to establish~     the utility of a rapid thoracic ultrasound exam to diagnose mechanisms of ventilation~     liberation failure and to assess the relationship between cardiothoracic variability during~     spontaneous breathing and different physiological mechanism of weaning failure.~   "
25488|NCT02723552|"~     TEPHRA investigates the effect of exercise on blood pressure and other cardiovascular~     factors in young adults with different birth histories. TEPHRA will recruit 200 participants~     from 18-35 years old with elevated blood pressure (100 participants pre-term born and 100~     full-term born). Half of the participants from each birth group will be randomised into a 16~     week supervised aerobic exercise intervention trial and the other half will be controls.~      Participants will complete 3 main study visits:~        -  Visit 1: Baseline visit conducted at beginning of study~        -  Visit 2: 16 weeks into study (upon completion of structured exercise intervention for~          the exercise group)~        -  Visit 3: End of study (52 weeks) Each visit will repeat the same set of cardiovascular~          measures including CPET, echo, blood pressure, vascular stiffness, and other measures.~           50 participants from each group will complete an MRI sub-study of the heart, brain, and~          liver.~   "
25489|NCT02723539|"~     This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with~     moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In~     Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1~     (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to~     Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to~     receive either topical application of MBN-101 or topical application of vehicle, applied~     directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum~     of 21 days. All patients will also receive systemic antibiotic treatment.~   "
25490|NCT02723526|"~     As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered~     a liquid biopsy, these circulating tumor cells (CTC) can show how a patient's cancer~     evolves and responds to treatments. The purpose of this study is to determine whether~     sequentially analyzing the expression of tumor markers in circulating tumor cells in newly~     diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of~     these patients.~   "
25491|NCT02723513|"~     The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance~     imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years~     born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term~     to characterize and probe the relationship between lung structure and function using~     imaging.~   "
25492|NCT02723500|"~     Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and~     Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion~     Coefficient (ADC) and ventilation defect volume obtained by analysis of hyperpolarized~     129-Xe MRI.~   "
25493|NCT02723487|"~     The primary objective of this study is to assess differences in postoperative pain~     experienced by pediatric patients having transversus abdominis plane block block with~     bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv~     analgesia after Laparoscopic surgery.~   "
25494|NCT02723474|"~     Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body~     weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the~     Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.~   "
25495|NCT02723461|"~     Comparing continuous intravenous oxytocin infusion with pulsatile administration of~     intravenous oxytocin for augmentation of the first stage of labor.~   "
25507|NCT02723305|"~     This study plans to learn more about how to measure the way the the body's energy system~     works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver.~     This is important to know so that investigators understand how hormones and an extra X~     chromosome relate to diseases such as diabetes, extra weight gain, heart disease and liver~     diseases.~   "
25508|NCT02723292|"~     As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is~     partnering with the City of Rochester Department of Recreation and Youth Services to~     evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth~     registered at 11 selected Recreation Centers (RCs). A youth development program with~     demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has~     never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will~     also measure program fidelity obtained in RCs.~   "
25496|NCT02723448|"~     The goal of the investigator is to utilize Aclarubicin to treat patients with Retinal~     Vasculopathy with Cerebral Leukodystrophy (RVCL), a rare and devastating genetic disease~     with no available specific treatment. RVCL results from a mutation in the tail end of the~     TREX1 (Three Prime Repair Exonuclease 1) gene, a major deoxyribonucleic acid (DNA) repair~     enzyme. The RVCL-specific mutations cause expression of a truncated and mislocalized~     protein. RVCL is an inherited disorder whose symptoms begin at middle age and initially~     predominantly affects the eye and brain. Because it is an 'autosomal dominant' disease, it~     strikes both males and females equally. A person with RVCL has a 50-50 chance of~     transmitting the gene to each child.~      The investigator's published studies demonstrated in a mouse model for RVCL and in vitro~     studies with patients' cells that defects were corrected by use of Aclarubicin, an~     anthracycline antibiotic often used to treat cancer. Thus, there is a strong rationale for~     conducting a clinical trial of aclarubicin in patients with RVCL.~      The dosage to be initially administered to RVCL patients initially will be < 10% of that~     typically used in cancer therapeutics and will be given monthly on four consecutive days for~     six months. Patients will undergo assessments every six months to determine disease~     response. Patients that do not have clear objective response may be dose escalated by 1 dose~     level with permission of the principal investigator permitting the patient has not~     previously experienced any toxicities requiring dose modifications. We will evaluate the~     safety and clinical efficacy of Aclarubicin for the treatment of RVCL and evaluate its~     effects on cellular function. This work will generate the first clinical research data on~     the investigational product's utility in treating RVCL.~   "
25497|NCT02723435|"~     This phase II trial studies the side effects and how well midostaurin works in treating~     older patients with acute myeloid leukemia with change in genetic material~     post-hematopoietic cell transplantation. Midostaruin may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving midostaruin post-transplant may~     improve patient outcomes.~   "
25498|NCT02723422|"~     The primary purpose of this this randomized interventional study is to determine if~     increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in~     transcatheter aortic valve replacement patients will improve functional status and quality~     of life and will decrease hospital readmission.~   "
25499|NCT02723409|"~     The primary objective of the study will be to determine which of five traditionally used~     umbilical reconstructive techniques offers superior aesthetic results. Additionally,~     secondary objectives of post-operative complications such as hypertrophic scar formation~     will also be measured.~   "
25500|NCT02723396|"~     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory~     improvement in motor function reported by around 50% of patients affected by Parkinson's~     Disease (PD) after sleep and before taking their first dose of dopaminergic medications.~     This study aims at systematically characterizing SB in PD patients in an ecological setting~     and to explore the relationships between nocturnal and diurnal sleep and subjective and~     objective measures of motor function. A better understanding of this phenomenon is mandatory~     for future research on this topic.~   "
25501|NCT02723383|"~     Background: Alcohol is the leading psychoactive substance consumed in France, with about 15~     million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA)~     considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for~     women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its~     incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness,~     extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without~     appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.~      Methods/Design: This prospective, randomised, controlled study versus placebo will be~     conducted in twelve French intensive care units (ICU). Patients with an alcohol intake~     higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary~     objective is to determine whether Baclofen is more efficient than placebo in preventing~     restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation~     duration, length of ICU stay, cumulative doses of sedatives and painkillers received within~     28 days of ICU admission. Restlessness-related side effects are defined as unplanned~     extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device~     removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be~     guided by creatinine clearance assessment once a day.~      Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA~     is a randomised study assessing the capacity of Baclofen to prevent agitation in~     mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is~     expected to end in June 2018.~   "
25502|NCT02723370|"~     The purpose of this study is to compare the effect of physician education about evidence~     based practices for colonoscopy alone, versus physician education plus a multi-component~     staff implementation strategy to improve adequacy of bowel preparation. Additionally the~     investigators will examine implementation factors that influence adoption of the evidence~     based practices.~   "
25503|NCT02723357|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on mental health using the Kessler-6 emotional distress scale.~   "
25504|NCT02723344|"~     Exaggerated inflammation in the body and brain is thought to play a role in the~     vulnerability to and aggravation and perpetuation of adverse consequences among those with~     co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study~     begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory~     probiotic to treat chronic symptoms associated with co-occurring mTBI and PTSD among~     Veterans. By looking at the impact of probiotic supplementation on biological signatures of~     increased inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers~     of peripheral inflammation, this study may lead to the identification of a novel~     intervention for the treatment of symptoms associated with these frequently co-occurring~     conditions.~   "
25505|NCT02723331|"~     The objective of this study is to estimate the R0 resection rate in patients with Resectable~     Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal~     Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of~     combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy~     (SBRT).~   "
25511|NCT02723253|"~     Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced~     rectal cancer with a positive impact on locoregional control and survival.However, patients~     with T4 rectal cancer show high risk of local recurrence after conventional treatment.~     Therefore investigators designed a prospective Phase II study on patients with locally~     advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of~     pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with~     concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.~   "
25512|NCT02723240|"~     A two-part, phase I open label, dose escalation and expansion study to assess safety,~     pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants~     with advanced solid tumours.~   "
25513|NCT02723227|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on family economic strain and parental stress.~   "
25514|NCT02723214|"~     The purpose of the present study is to compare the characteristics, i.e. efficacy, duration,~     safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the~     standard frame-based stereotactic technique.~      Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive~     diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically~     inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for~     which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or~     too old for open craniotomy.~      Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless~     fiducial-less method using an optical based navigation system and a mini frame apparatus -~     trajectory guide.~   "
25515|NCT02723201|"~     The purpose of this study is to assess the relative bioavailability of solid oral~     formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation~     and to evaluate the food effect and potentially the dose proportionality of the optimal oral~     solid formulation.~   "
25516|NCT02723188|"~     The aim of this study is to examine the effects of transcranial electrical stimulation on~     processes associated with fear extinction in healthy humans.~   "
25517|NCT02723175|"~     Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and~     combined CBT+ tDCS on clinical pain and functioning among a sample of patients with~     fibromyalgia. This study will be the first randomized, double-blind, controlled study of~     tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from~     this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT~     as a chronic pain-management approach.~   "
25518|NCT02723162|"~     This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine~     (NAC) on neural circuitry function and treating nicotine addiction. Healthy adult nicotine~     dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four~     PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO.~     Following 1 week of medication, participants will be contingently reinforced for 3 days of~     smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI)~     techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task.~     Participants will be followed over the next 3 weeks of treatment and clinical variables will~     be assessed.~   "
25519|NCT02723149|"~     This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention~     reduces cannabis use compared to a control condition containing no active components of AAT.~     Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or~     control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed~     to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham~     conditions. Substance use and cognitive assessment will identify changes in MJ use patterns~     and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance~     imaging marijuana cue reactivity task, we will determine differences in neural response in~     reward regions before and after 3 weeks of either AAT or sham treatment.~   "
25520|NCT02723136|"~     This study addresses the effectiveness of a smartphone application to improve academic~     performance among medical students. Participants will be randomised to receive an~     application developed by a team of physicians and engineers, designed to review key concepts~     in internal medicine and its subspecialties. The primary outcome will be the number of~     correct answers in a multiple choice test 4 weeks after randomisation.~   "
25521|NCT02723123|"~     Non-invasive respiratory support is routinely provided to extremely preterm infants~     following disconnection from mechanical ventilation, in the form of continuous positive~     airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV). However, these~     modes remain sub-optimal due to lack of synchronization and upper airway defensive~     mechanisms that potentially hinder their effectiveness. Non-invasive Neurally Adjusted~     Ventilatory Assist (NIV-NAVA) is a novel mode that may overcome some of these problems but~     has not been investigated in this population. Investigators hypothesize that there will be~     significant differences in cardiorespiratory behavior in extremely preterm infants receiving~     CPAP, NIPPV and NIV-NAVA during the immediate post-extubation period.~   "
25522|NCT02723110|"~     Recent genetic association studies have identified variants in the Peptidyl-Glycine~     alpha-amidating mono-oxygenase (PAM) gene that increase the risk of diabetes likely through~     a defect in beta-cell function. This has been followed up and supported by novel kinetic~     assays and cellular studies. This investigation will recall heterozygous carriers of the~     risk allele at rs78408340 and age, BMI and gender matched controls from the Oxford Biobank.~     The study will compare the incretin effect, glucagon-like peptide-1(GLP-1), insulin, glucose~     levels and PAM protein activity in individuals both with and without the risk variant. The~     aim of the study is to gain mechanistic insight into the effect of the variant on human~     physiology and diabetes pathogenesis.~   "
25523|NCT02723097|"~     The objective of this protocol is to test the feasibility and acceptability of the~     Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety~     of mind body skills and interventions to decrease medical and mental health symptoms and~     build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its~     clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety,~     and lower respiratory symptoms (LRS) and improve psychosocial functioning.~   "
25528|NCT02723032|"~     By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery~     glasses which dissimulates the nasal cannula, the investigators hope to optimize and long~     term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel~     SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by~     eyeglasses using a closed-loop system.~   "
25529|NCT02723019|"~     Mi Puente (or My Bridge) is a culturally-tailored, interdisciplinary approach designed to~     support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as~     they navigate the multi-level barriers that contribute to inequities in health care access~     and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi~     Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership~     between inpatient and outpatient care settings to meet the integrated (i.e., physical and~     behavioral) health needs of Hispanics who are hospitalized with multiple chronic~     cardiometabolic conditions and one or more behavioral health concern(s). Participants will~     be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in~     the US/Mexico border region of South San Diego County, CA. The proposed randomized~     controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice~     discharge procedures) in improving hospital utilization, patient-reported, and cost~     effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible~     patients and examine primary outcomes.~   "
25530|NCT02723006|"~     The purpose of this study is to determine the initial safety profile and initial antitumor~     activity of the combination treatments (immune checkpoint inhibitors [nivolumab, ipilimumab]~     with investigational drugs [TAK-580, TAK-202 (plozalizumab), vedolizumab]) in the 3 arms~     when administered to participants with advanced melanoma.~   "
25531|NCT02722993|"~     To assess the effect of a probiotic product, when co-administered with antibiotics, on~     gastrointestinal symptoms following antibiotic treatment in children.~   "
25532|NCT02722980|"~     The aim of the current study is to evaluate the efficacy of a probiotic product on bone~     mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The~     primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of~     12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes~     in bone turnover markers during the period of 12 months.~   "
25533|NCT02722967|"~     This study will assess the helpfulness of the integrated call center in optimizing use of~     the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder,~     or Bipolar Disorder taking oral aripiprazole.~   "
25534|NCT02722954|"~     The purpose of this study is to test the efficacy and safety of an experimental drug,~     demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized~     monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the~     growth of cancer stem cells, the remaining cancer cells, and it may also impair the~     productive growth of new blood vessels, which tumors need to grow and spread.~      This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the~     Sponsor in this consent form.~   "
25535|NCT02722941|"~     The purpose of this study is to learn more about ways to prevent or delay relapse of~     multiple myeloma (MM). This study will determine the best dosing schedule of LBH589~     maintenance therapy as well as the safety (side effects) and tolerability of LBH589~     maintenance therapy after autologous hematopoietic cell transplant (HCT).~   "
25536|NCT02722928|"~     The aim of this study is to compare the incidence and volume of postoperative pneumocephalus~     in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a~     conventional 1:1 oxygen/air gas mixture.~   "
25537|NCT02722915|"~     The aim of the study is the examination of brain plasticity on verbal auditory~     hallucinations (AVH) after neuromodulation with fMRI (functional magnetic resonance imaging)~     neurofeedback. During the training of fMRI neurofeedback subjects are trained to regulate~     consciously the connectivity of areas which are associated with hallucinations.The aim is to~     improve perceived hallucinations' intensity in everyday life of the patients as well as~     investigating the impact of neurofeedback on resting-state networks in the brain. As control~     groups, control subjects without AVH and participants with AVH, but no psychiatric diagnosis~     will be included.~   "
25538|NCT02722902|"~     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased~     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state~     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is~     an early hallmark in the development of diabetes. Recent evidence suggests that a low~     carnitine availability may limit acetylcarnitine formation, thereby reducing metabolic~     flexibility. Thus, when substrate flux in the muscle is high, acetyl-CoA concentrations~     increase, leading to inhibition of pyruvate dehydrogenase (PDH) and thereby reducing glucose~     oxidation. The conversion of acetyl-CoA to acetylcarnitine relieves this acetyl-CoA pressure~     on PDH. To provide more direct insight into the effect of carnitine in preventing metabolic~     inflexibility and insulin resistance and to further explore the mechanism of action is the~     focus of this research. Here, we hypothesize that the capacity to form acetylcarnitine may~     rescue lipid-induced insulin resistance. To this end, insulin resistance will be induced by~     lipid infusion in healthy volunteers and it will be tested whether carnitine co-infusion can~     alleviate insulin resistance.~   "
25539|NCT02722889|"~     Aim of this study is to measure length of the ascending aorta in adults and to investigate~     the clinical implication of 'elongation' of the aorta.~   "
25540|NCT02722876|"~     The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation~     intervention following anterior cruciate ligament reconstruction on ameliorating the acute~     losses to function and performance. The cross-education phenomenon describes the strength~     gain in the opposite, untrained (surgical) limb following unilateral resistance training of~     the 'trained' (non-surgical) limb.~   "
25541|NCT02722863|"~     This Post-Marketing Surveillance will be conducted in accordance with the local regulation~     of New Drug Re-examination. The surveillance will be conducted for 6 years of the~     re-examination period (01Sep2011~31Aug2017). Each subject will be observed at least for 4~     days during the surveillance period.~   "
25542|NCT02722850|"~     In this parallel group study, participants were randomized to either 1 of 3 conditions (a)~     fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.~   "
25543|NCT02722837|"~     This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) fixed dose combination (FDC) for 12 weeks in participants~     with chronic hepatitis C virus (HCV) infection.~   "
25544|NCT02722824|"~     Investigation efficacy of a non-invasive wearable electrostimulator device where the~     supplementary motor area, premotor area and/or subthalamic nucleus are stimulated~     bilaterally and extracranially.~   "
25545|NCT02722811|"~     Primary aim: evaluate efficacy of subcutaneous injection of etanercept for moderate and~     severe knee osteoarthritis.~      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),~     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of subcutaneous~     injection of etanercept for moderate and severe knee osteoarthritis.~   "
25546|NCT02722798|"~     The purpose of the study is to evaluate the efficacy and safety of KRN23 after its 48-week~     once every 4 weeks repeated subcutaneous administration to Japanese and Korean patients with~     Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome by a multicenter, open-label,~     intraindividual dose adjustment study~   "
25547|NCT02722785|"~     Background:~      For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the~     perioperative course of therapy is associated with severe deconditioning which includes~     weight loss and poor physical function, which are strong predictor of post-surgical~     complication and survival . A strong rationale exists to explore how to develop supportive~     interventions aimed at maintaining/improving muscle function (lean body mass and muscle~     strength) during the pre-surgical phase.~      This study explores the safety, feasibility and efficacy of structured pre- and~     post-operative exercise training in patient undergoing surgery for cancer of the~     gastro-esophageal junction.~      Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ~     scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.~      Methods: In a case-control design, patients will be allocated to either an exercise training~     intervention group, or a usual-care observational group, based on geographical location.~     Forty patients will be included in this case-control study and allocated by geographical~     region as follows; 20 training intervention-cases living in the greater Copenhagen area, and~     20 observational control subjects living outside the greater Copenhagen area.~      All patients will undergo a total of 5 assessments during the perioperative trajectory;~     twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and~     15 weeks post-surgery, and at 1-year follow-up).~      Assessments include measures of body composition by DXA scan and bioelectrical impedance~     analysis: systemic inflammation in fasting blood sample; quality of life by self-report~     questionnaires; physical function by handgrip strength and sit-to-stand test.~      As optional procedures, we will collect biological tissue from tumor, muscle and fat~     biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will~     collect blood samples before, during and after an acute exercise bout exercise in order to~     explore the acute systemic changes in exercise-regulated biomarkers.~   "
25548|NCT02722772|"~     Primary aim: evaluate efficacy of intra-articular injection of etanercept for moderate and~     severe knee osteoarthritis.~      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),~     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of intra-articular~     injection of etanercept for moderate and severe knee osteoarthritis.~   "
25549|NCT02722759|"~     In this prospective study different methods of haemoglobin measurement in term and preterm~     neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the~     Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@,~     Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin~     measurement by an automated hematology analyzer (labHb, Siemens Advia®).~   "
25550|NCT02722746|"~     Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely~     and very successfully used routinely for perioperative pain control in patients undergoing~     major orthopedic and abdominal surgery since 1928. The choice currently depends on the~     preference of the APS physician in charge of the case. A frequent unwanted side effect of~     epidural block is hypotension due to the epidurally injected LA blocking the sympathetic~     nerves and thus the patient's response to hypotension, which is usually due to hypovolemia~     and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of~     this research study is to see if adding epinephrine, to the epidural anesthetic will~     decrease possible side effects, such as low blood pressure, and lead to a better effect of~     the epidural anesthetic.~   "
25551|NCT02722733|"~     The purpose of the study is to compare safety and efficacy of stem cell mobilization using~     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's~     lymphoma and non-Hodgkin's lymphoma patients.~   "
25552|NCT02722720|"~     The aim is to compare the safety of using transfemoral and transradial approach in patient~     undergoing carotid arteries stenting.~   "
25553|NCT02722707|"~     This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for~     fecal incontinence. This device is indicated for the treatment of fecal incontinence in~     patients who are not candidates for or have previously failed conservative treatment and~     less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve~     stimulation).~   "
25554|NCT02722694|"~     The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg~     administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects~     who have active rheumatoid arthritis, are receiving methotrexate and experiencing an~     inadequate response to methotrexate. This will be estimated by the proportion of subjects~     meeting the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).~   "
25555|NCT02722681|"~     'Spinal lipoma' is a condition, present from before birth, in which fatty tissue (lipoma) is~     attached to the lower end of the spinal cord, tethering it within the vertebral canal. The~     cord normally moves up and down with respiration, whereas tethering prevents this movement,~     and can lead to progressive neurological deterioration. The cord and spinal nerves become~     stretched and their blood supply is damaged irreversibly. Disability may include weakness or~     pain in the lower body, and urinary disorders in young children. Treatment is surgical, to~     remove the lipoma and mobilise the spinal cord, with 60 such operations performed per year~     at Great Ormond Street Hospital. This project aims to develop lipidomic biomarkers in order~     to predict which children with spinal lipoma are at highest risk of neurological~     deterioration, and require early surgery, while providing evidence to adopt a more~     conservative approach for those at lower risk.~   "
25556|NCT02722668|"~     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body~     irradiation (TBI) preparative regimen with modifications based on factors including~     diagnosis, disease status, and prior treatment. Single or double unit selected according to~     current University of Minnesota umbilical cord blood graft selection algorithm.~   "
37415|NCT02567305|"~     This study is designed to assess the role of neutrophil extracellular traps (NETs) in~     neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early~     predictors of neonatal and pediatric sepsis.~   "
25557|NCT02722655|"~     The aim of this study is the identification of complications in diabetes mellitus pediatric~     patients and to compare the clinical, anthropometric, and biochemical characteristics~     between children in the different types of diabetes mellitus.~   "
25558|NCT02722642|"~     Bronchiectasis is a result of chronic inflammation compounded by an inability to clear~     mucoid secretions. Inflammation results in progressive destruction of the normal lung~     architecture, in particular the elastic fibers of bronchi. Currently there is no effective~     drug for bronchiectasis. This study intends to carry out an open, single-center,~     non-randomized, self control phase I/II clinical trial. During the treatment, bronchial~     basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and~     expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic~     bronchoscopy after lavage. After six-month observation, the investigators will evaluate the~     safety and effectiveness of the treatment by measuring the key indicator-- the CT imaging of~     dilated bronchi as well as four secondary indicators including the pulmonary function,~     laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.~   "
25559|NCT02722629|"~     The aim of the study is to estimate the prevalence of respiratory aspiration in patients~     with COPD, in a tertiary hospital of Buenos Aires.~   "
25560|NCT02722616|"~     This research study is being done to collect data and analyze the motion of soft tissue in~     the abdomen (liver, pancreas, stomach and intestines) of people who have pancreatic and~     liver cancer as well as healthy volunteers.~      During the study researchers will look at the movement of organs in the abdomen that~     naturally occurs with breathing and with a bowel movement.~      This study will examine the differences between abdominal soft tissue motion in healthy~     volunteers and in cancer patients with the goal of developing a better way to manage and~     minimize the abdominal soft tissue motion. Accurate location of the tumor is very important~     in treatment delivery and reduction of toxicity.~   "
25561|NCT02722603|"~     This study evaluates the efficacy and safety of gabapentin relative to tramadol for the~     treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from~     3 months to less than 18 years of age experiencing moderate to severe chronic pain will~     receive either gabapentin or tramadol for 15 weeks. The difference in average pain scores~     between treatment arms at the end of the treatment period will be assessed.~   "
25562|NCT02722590|"~     The objective of this post-marketing surveillance study is to observe the safety profile of~     Fycompa film-coated tablets 2/4/6/8/10/12 milligrams (mg) in a normal clinical practice~     setting.~   "
25563|NCT02722577|"~     Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the~     successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).~   "
25564|NCT02722564|"~     This will be a prospective survey study. The participants will all be volunteers of legal~     drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then~     will be asked to verbally estimate their current blood alcohol concentration and if the~     subject feels they are able to drive. At that time, their BAC level will be measured~     objectively using a breath alcohol test (BAT) device. The participant will not be told their~     objective value. This will continue with a verbal estimate and actual BAT reading after~     every drink until the participant reaches a minimum BAC of 0.10. At this time, participants~     will continue to be monitored until their BAC falls to 0.08 and they are clinically sober.~     As their blood alcohol level decreases, the investigators will ask the participant to~     estimate their level every hour along with an actual reading until reaching 0.08.~     Statistical analyses will be used to determine how accurate self estimation is in regards to~     blood alcohol content.~   "
25565|NCT02722551|"~     Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter~     Mitral Valve~   "
25566|NCT02722538|"~     The purpose of this study is to determine if GemRIS, an investigational drug-delivery~     system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between~     diagnosis and radical cystectomy (RC).~   "
25567|NCT02722525|"~     Learning about the impact of anti-androgen treatment has on cardiac function in patients~     with prostate cancer may help plan treatment and help patients live more comfortably. This~     pilot clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient~     starts hormone therapy and after 4 to 7 months of hormone therapy. The objective is to~     measure the impact of hormone therapy (anti-androgen treatment) on cardiac function in~     patients with prostate cancer.~   "
25568|NCT02722512|"~     The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96~     (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with~     newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and~     Ependymomas.~   "
25569|NCT02722499|"~     The aim of this study is to test the efficacy of financial incentives augmented~     telephone-delivered diabetes education and skills training intervention in improving HbA1c~     levels in African Americans (AA) with type 2 diabetes (T2DM).~   "
25570|NCT02722486|"~     The investigators aim to compare rehabilitation progress between control patients who will~     undergo routine vestibular rehabilitation exercises and experimental patients who will~     undergo exercises using a vibrotactile balance belt (Sensory Kinetics Balance Rehabilitation~     System) in addition to their routine vestibular rehabilitation regimen during recovery from~     diseases affecting the vestibular system. The results of this pilot study will help to~     determine if the vibrotactile balance belt is a useful supplement to traditional vestibular~     rehabilitation techniques in children suffering from vestibular impairment.~   "
25582|NCT02722330|"~     The aim of this clinical investigation is to evaluate objective and subjective hearing~     performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System,~     compared to the unaided hearing performance. Comparison of audiological test results with~     the same sound processor on a Baha Softband will also be performed. Short term safety~     parameters will be collected.~   "
25583|NCT02722317|"~     It was realized a case study in a batterer intervention program, where 86 men accepted to~     participate. It was used the Centers for Disease Control and Prevention - Follow up~     questionnaire, adapted to be used in Brazil.~   "
25584|NCT02722304|"~     The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of~     weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects~     with A1PI deficiency and Chronic obstructive pulmonary disease (COPD).~   "
25571|NCT02722473|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible~     for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality~     of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to~     the initial cardiac rhythm present during the initiation of resuscitation. Recent progress~     in the improvement of mortality and neurological outcome has been achieved over the last~     decade thanks to the systematic implementation of a period of targeted temperature control~     between 32 and 34 ° C in patients who benefited from the realization of at least one~     electrical external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period~     of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~      NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain~     biomarker) of two temperature target for targeted temperature management (33°C or 37°C)~     after cardiac arrest in non-shockable rhythm.~   "
25572|NCT02722460|"~     The aim of the study is to determine surrogate markers for prognostication of unfavorable~     outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These~     patients are comatose. Conscious patients are unsuitable for prognostication.~   "
25573|NCT02722447|"~     The treatment of isolated distal deep vein thrombosis remains one of the most debated issues~     in the field of venous thromboembolism and only very few studies have directly addressed the~     issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of~     this study is to assess the long-term risk of recurrent venous thrombotic events in patients~     with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with~     a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.~   "
25574|NCT02722434|"~     This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous~     electrical nerve stimulation (TENS) therapy work in treating patients with~     chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness,~     tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler~     therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where~     electricity is carried from the electrodes through the skin and blocks the pain. TENS is a~     procedure in which mild electric currents are applied to some areas of the skin. It is not~     yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating~     chemotherapy-induced peripheral neuropathy.~   "
25575|NCT02722421|"~     The purpose of this study is to determine whether increasing the dose of the levonorgestrel~     subdermal contraceptive implant will overcome a detrimental drug-drug interaction with~     efavirenz based antiretroviral therapy.~   "
25576|NCT02722408|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple~     doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.~   "
25577|NCT02722395|"~     This study is a research and development initiative established to explore the use of~     magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer~     patients planning procedures for stereotactic body radiation therapy (SBRT).~   "
25578|NCT02722382|"~     Objective: The investigators will change the health system to improve care patients receive~     as they transition through earlier stages of kidney disease toward kidney failure. They will~     study whether these changes lead to patients' improved health and well-being.~      Methods: The investigators will conduct this study in Geisinger Health System kidney~     specialty clinics. The study will implement 'Patient Centered Kidney Transitions Care' which~     will (1) give doctors tools to help them recognize when patients should prepare for kidney~     failure and help them support patients' early and informed treatment decisions; and (2) add~     a 'Kidney Transitions Specialist' to the health care team to help patients learn about~     kidney disease, learn self-care skills, make informed decisions, get psychosocial support,~     and coordinate their care. Four (4) clinics will be randomly assigned to provide Patient~     Centered Kidney Transitions Care, and four (4) to provide their usual care. The~     investigators will study differences in patients' outcomes among those treated in clinics~     providing Patient Centered Kidney Transitions Care compared to those treated in clinics~     providing usual care.~      Patient Outcomes: Patients have told us they want to have 'control' over their disease~     transitions and to have the best quality of life possible. The investigators will measure~     patients' empowerment, confidence with their self-care, their decisions to start self-care~     treatments for kidney failure, and their hospitalizations. They will also measure whether~     doctors record patients' treatment preferences in the medical record before patients develop~     kidney failure.~      Patient and Stakeholder Engagement: This study responds to reports from hundreds of patients~     and caregivers who want better care. Patients and caregivers from around the US are part of~     our investigative team, and they will participate in all aspects of our study. The~     investigators are also engaging key stakeholders in the kidney community, including~     patients, providers, payers, and regulators.~      Anticipated Impact: If effective, Patient Centered Kidney Transitions Care will provide a~     model of care can improve the lives of patients and families with kidney disease across the~     US.~   "
25579|NCT02722369|"~     To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine~     (HCQ) is associated with an improved clinical outcome (progression free and overall~     survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)~   "
25580|NCT02722356|"~     The proposed study is a prospective, randomized, active control, open label study. One~     hundred sixty subjects undergoing elective cesarean section will be randomly assigned to one~     of two groups (n = 80 per group): the oxytocin protocol group or the standard practice~     group. The oxytocin protocol group will receive oxytocin boluses along with a regulated~     infusion according to a stepwise algorithm following delivery of the placenta. The standard~     practice group will receive oxytocin via a free flowing (wide-open) infusion with a~     concentration of 30 IU per 500 mL of 0.9% normal saline following the delivery of the~     placenta. Primary outcomes include uterine tone (adequate or inadequate) as assessed by the~     surgeon, amount of time required to establish adequate uterine tone following the delivery~     of the infant, total dose of oxytocin required to establish adequate uterine tone, and total~     calculated blood loss based on pre-operative and post-operative hematocrit concentrations.~     Secondary outcomes include total estimated blood loss as agreed upon by the surgeon and the~     anesthesia provider, use of additional uterotonic drugs, mean arterial pressure, and~     incidence of oxytocin side effects (nausea, chest tightness/pain, and ST-segment changes).~   "
25581|NCT02722343|"~     This single site study is designed to describe and measure the efficacy of oral versus~     vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil~     fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).~   "
25587|NCT02722265|"~     To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration~     of CS-3150 as monotherapy and in combination with calcium channel blocker or~     renin-angiotensin system inhibitor in patients with essential hypertension.~   "
25588|NCT02722252|"~     The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology~     embryo culture systems, with incubation characteristics that are potentially superior to~     those provided by classical culture systems. Indeed, these two systems, available in only~     two MAP centres in France, make it possible to maintain a stable temperature and gaseous~     environment during the in-vitro development of the embryos.~      It is necessary to observe the development of the embryos to determine which embryos have~     the highest implantation potential. These observations are done from time to time by~     microscope for one system and continuously using an incorporated video camera for the other~     (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two~     systems.~   "
25589|NCT02722239|"~     The aim of this study is to demonstrate bioequivalence of fixed dose combination~     Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg,~     (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg~     (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2~     x 500 mg) (Merck Santé S.A.S., France) which are already registered in the Russian~     Federation.~   "
25590|NCT02722226|"~     Objective Sedation is a depression of consciousness varies between anxiolysis and general~     anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory~     complication is the main side effect of the sedation. His Early diagnosis and adequate~     management prevent serious complications such as hypoxic brain damage or death. A~     development of a learning program of sedation is required. Simulation as a teaching tool has~     improved the clinical expertise of learners. The objective of the study is to evaluate the~     impact of a simulation based medical education program on the performance of non-resident~     anesthesiologists for the management of complications related to sedation.~      Methods This trial is randomized, controlled and single blinded. Non-resident~     anesthesiologists, without prior training on sedation, are included and randomized to~     receive or not a simulation based sedation learning. This program includes a pharmacology~     sedatives learning, teaching technical skills for airway management on low fidelity~     mannequin and high-fidelity simulation scenarios of these complications. Two evaluators,~     single-blinded, visualise the recorded performance of residents in simulation session. The~     evaluation is based on a performance checklist developed by Delphi technique. It compares~     the performance of the residents within the same group before and after the simulation based~     medical education program and to compare groups of residents.~      Data analysis The sample size is based on similar simulation studies. The results are~     compared with the variance analysis for repeated measures. The difference in performance~     before and after simulation is compared using a t test.~      The investigators hypotheses that improved performance scores following the simulation based~     medical education would put the dot on the importance of simulation as a learning tool.~   "
25591|NCT02722213|"~     The guideline-recommended standard of care for patients who have experienced a heart attack,~     heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation~     (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is~     typically lacking from traditional CR programs is effective psychosocial risk management.~     This represents a critical gap in care given the well-documented psychosocial needs of this~     patient population.The objective of this feasibility study is to conduct a pilot randomized~     controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in~     CR-eligible cardiac patients. Randomization will be stratified within two strata based on~     participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot~     study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate~     recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in~     CR-eligible patients.~   "
25592|NCT02722200|"~     The purpose of this study is to examine if glucocorticoids will change neural activation in~     regions of the corticolimbic-striatal system that regulate feeding.~   "
25593|NCT02722187|"~     This study is to set the place of microsurgery in surgical treatment od varicocele in~     infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while~     the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.~   "
25594|NCT02722174|"~     The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders~     clinically associated with impulsivity and in health controls, to: 1) investigate if the~     different populations have a distinct behavioral profile, and 2) to investigate if there are~     specific measures that are reliable and sensitive measures of impulsivity across diagnoses.~   "
25595|NCT02722161|"~     To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and~     [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a~     single oral dose of [14C]BI 1482694 given to healthy male volunteers~   "
25596|NCT02722148|"~     This is a prospective single center clinical trial of allergen-specific immune~     signature-guided dietary elimination therapy to assess the clinical effectiveness of this~     technique.~   "
25597|NCT02722135|"~     This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for~     further development by evaluation of DLT in course 1 and the safety of volasertib when added~     to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML~     after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib~     in paediatric patients with AML when added to standard intensive salvage chemotherapy will~     be collected.~   "
25598|NCT02722122|"~     This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy~     Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.~   "
25599|NCT02722109|"~     Researchers want to compare proton stopping ratios, used for proton beam therapy planning,~     calculated based on single energy CT and dual energy CT images; with the intension of~     improve upon the proton range determination.~   "
25638|NCT02721602|"~     The current study proposes to study the feasibility and acceptability of the Families~     Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed~     with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful~     recruitment, measurement and randomization of patients and their families will provide data~     for our aim of assessing feasibility. Patient and family participation in the intervention~     and feedback via the post-intervention surveys will provide data for our aim of~     acceptability.~   "
25639|NCT02721589|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The~     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended~     phase II doses of SHR-1210 in patients with advanced solid tumors~   "
25600|NCT02722096|"~     Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is~     the best primary vascular access for hemodialysis in patients with end stage renal disease.~     The primary complications are common, of the order of 10-36 %, including lack of maturation~     and dominated by stenosis and thrombosis.~      Local anesthesia associated with sedation is a validated method of anesthesia for made~     arteriovenous fistula but does not cause the motor block and not blocking vasospasm,~     deleterious to the surgery. Multiple injections necessary to cover the operating zone expose~     patient to pain and to intravascular injection of local anesthetics.~      Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic~     block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It~     enables an increased flow rate at an early time fistula and faster maturation.~      However, studies included low numbers of patient or are non-randomized. They cannot~     concluded a significant difference in the complication rate of arteriovenous fistula at an~     early time depending on the type of anesthesia .~      This study aims to demonstrate that axillary block for surgical creation of arteriovenous~     fistula allows a reduction of complications at 6 weeks compared to local anesthesia~   "
25601|NCT02722083|"~     The purpose of the study is to explore the onset of effect of an antihistamine in a~     controlled environment.~   "
25602|NCT02722070|"~     The main objective of the study is to explore and map brain areas involved in processing and~     perception in patients suffering from neurological pathologies and condition. The~     investigators hypothesize for example, that a change (compare to healthy subjects) in the~     perceptual maps and body representation could be detected and characterize in patients~     suffering from impairments of peripheral nerve conduction.~   "
25603|NCT02722057|"~     The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco®~     (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe~     the long-term safety and effectiveness of Kalydeco in CF patients with the R117H-CFTR~     mutation overall and in patients ≥18 years. The long-term safety and effectiveness of~     Kalydeco will be examined in totality through the evaluation of the primary outcome~     measures.~   "
25604|NCT02722044|"~     The purpose of this study is to evaluate the usability of an auto-injector (AI) for the~     delivery of M923 in patients with rheumatoid arthritis (RA)~   "
25605|NCT02722031|"~     Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia~     among patients admitted in ICU is not well known, in partly due to a lack of a consensual~     definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome~     whom the definition has been recently modified in 2011. Many uncertainties are remaining in~     considering the patients with ARDS: prevalence of the category of mild ARDS, the~     proportion of patients with invasive mechanical ventilation, the therapeutic modalities and~     the prognosis, in particular, the move towards a more severe ARDS category. Finally, many~     patients with hypoxemia do not meet ARDS definition. The prevalence of this population in~     ICU is unknown, likewise its prognosis. In this way, it would be interesting to compare, for~     each levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and~     without ARDS.~      The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in~     French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study~     design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the~     31st Mars and from the 5th to the 7th April. In each participating center, the day of the~     study will be chosen among these periods.~   "
25606|NCT02722018|"~     This is phase 1, randomized, open-label, single center, crossover study to investigate the~     effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy~     participants of non-childbearing potential. This study is divided into three parts.~     Participants in each part will be randomized to one of three treatment sequences. Part 1~     study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK)~     of GDC-0810 administered with low-fat food. Each participants in this part will receive a~     single dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes~     after the start of the meal) in each treatment period. Part 2 is an optional Phase I study~     in 3 periods to investigate the effect of formulation on the PK of GDC-0810 administered~     with low-fat food in healthy female participants of non-childbearing potential. Part 3 study~     in three periods will compare the PK of a Phase III prototype tablet formulation selected~     from Parts 1 and 2 of the study with the Phase II tablet formulation (both administered 30~     minutes after the start of a low fat meal) at dose level B and to investigate the PK of the~     Phase III prototype formulation administered in the fasted state.~   "
25607|NCT02722005|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on health related quality of life using the Patient Reported Outcome Measurement~     Information System (PROMIS) 10 Global Short Form.~   "
25608|NCT02721992|"~     The investigators have recently observed retrospectively that the occurrence of Graves'~     Orbitopathy in patients with Graves' disease is less frequent in patients with normal~     cholesterol levels, in line with another recent observation suggesting that statins play a~     protective role in Graves' patients from developing Graves' Orbitopathy. The present study~     is designed in order to investigate the possible association between Graves' Orbitopathy and~     high cholesterol level as well as the relation between Graves' Orbitopathy degree and high~     cholesterol level~   "
25609|NCT02721979|"~     This phase II trial studies how well ARN-509 (androgen receptor antagonist ARN-509) works in~     treating patients with prostate cancer who are in active surveillance. Testosterone can~     cause the growth of prostate cancer cells. Hormone therapy using androgen receptor~     antagonist ARN-509 may fight prostate cancer by blocking the use of testosterone by the~     tumor cells.~   "
25610|NCT02721966|"~     The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or~     300 mg in the management of axial manifestations in PsA patients who have failed to respond~     to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according~     to assessment of spondyloarthritis international society (ASAS) recommendations for the~     treatment of axial spondyloarthritis (AxSpA).~   "
37416|NCT02567292|"~     This study aims to identify whether an all breast milk (BM) diet would improve outcomes in~     neonates with congenital gastrointestinal disorders (CGD) by facilitating an earlier~     transition off of parenteral nutrition (PN).~   "
25611|NCT02721953|"~     Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested~     starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal~     level, including: immune regulation with anti-inflammatory effect at intestinal and systemic~     level and modulation of gut microbiota. Many of these effects result from an epigenetic~     mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that~     butyrate can exercise very effective protective action against obesity through the~     stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced~     by HFD, that butyrate is effective in preventing and treating obesity and insulin~     resistance. After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of~     body weight, 30% of fasting glucose and 50% insulin resistance.~      In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated~     that the administration of butyrate is able to significantly reduce insulin resistance,~     liver damage, dyslipidaemia through a modulation of the inflammatory process.~      Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of~     butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral~     administration.~      All of these data makes plausible a possible positive effect on insulin resistance in the~     obese child.~   "
25612|NCT02721940|"~     This study was mainly aimed to evaluate the efficacy of local administration of enriched~     bone marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of~     collapse of the early-stage osteonecrotic femoral head.~   "
25613|NCT02721927|"~     Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were~     forced to leave their homes and sought refuge in neighboring countries.~   "
25614|NCT02721914|"~     The main goal of this study is to get to know if applying both, massotherapy plus~     hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low~     back pain. It actually reduces the inability produced by the pain and improve the patient's~     quality of life as well as the join range of the lumbar spine, way more than these two~     therapies applied separately.~   "
25615|NCT02721901|"~     The purpose of this study is to further develop the integrated Eating Aversion Treatment~     (iEAT) manual, which is designed to address chronic food aversion in children with chronic~     food refusal. This study will evaluate the feasibility and efficacy of the iEAT manual when~     it is used in the home home environment with caregivers.~   "
25616|NCT02721888|"~     Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic~     syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be~     associated with lipid abnormalities (such as hypertriglyceridemia and decreased~     HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities~     (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type~     2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated~     between 3 and 5%).~      Animal studies have shown that liraglutide is able to decrease liver fat content, but the~     effect of liraglutide on liver fat content in patients with diabetes remains unknown.~      In addition, human studies with liraglutide have shown significant modification of plasma~     lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the~     mechanisms responsible for these liraglutide induced lipid modifications are not yet known.~      Because increased in liver fat content and hypertriglyceridemia are associated in patients~     with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver~     fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver~     fat content assessment and kinetic study with stable isotope to study lipoprotein~     metabolism).~      This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in~     patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide~     therapy (1.2 mg/day).~      Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in~     10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month~     period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a~     2-day hospitalization~      For the main study, 3 visits will be performed:~        -  a first visit at T0, before starting the treatment with liraglutide, including clinical~          and biological measurements and liver fat content assessment by proton-spectroscopy~        -  a visit at 3 months including clinical and biological measurements~        -  and a visit at 6 months including clinical and biological measurements and liver fat~          content assessment by proton-spectroscopy~      For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will~     been performs during a 48h-hospitalization before starting the treatment with liraglutide~     and after 6 month-treatment with liraglutide~   "
25617|NCT02721875|"~     The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated~     dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules~     of intravenous volasertib as monotherapy or in combination with azacitidine in patients with~     myelodysplastic syndrome (MDS) after hypomethylating agents (HMA) treatment failure.~   "
25618|NCT02721862|"~     This is a randomized double-blind placebo-controlled trial with a total of 100 patients who~     are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic~     Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of~     three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for~     gallstones.~   "
25619|NCT02721849|"~     A randomized controlled trial to investigate the efficacy of yoga on tension type headache~     and / or migraine in adolescents between 12 and 16 years, consisting of a four group design~     which includes an 12 week yoga course and a three-month follow-up period. Both adolescent~     and one parent will be randomized either to yoga or no treatment. Primary outcome will be~     pain frequency in adolescents considering pain catastrophizing of parents.~   "
25620|NCT02721836|"~     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit~     of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to~     nutrition counselling. Further, the potential of both interventions to influence the gut~     microbiome will be inquired.~   "
25621|NCT02721823|"~     Patients with ulcerative colitis often suffer significant limitations to their quality of~     life, which are also conditioned by particular stress and psychosocial accompanying symptoms~     of the disease. A multimodal program for stress-reduction and lifestyle-modification has~     been shown to be effective in promoting the quality of life. The study will examine the~     promotion of the quality of life of patients with ulcerative colitis and the positive~     Influence on stress, psychological symptoms and physiological parameters. 92 patients with~     ulcerative colitis will be randomized in an Intervention group and a control group for 10~     weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes~     are stress, psychological symptoms, inflammatory parameters, disease activity parameters,~     bowel parameter and the microbiome.~   "
25622|NCT02721810|"~     A no-cost intervention may improve adherence with a recommendation for higher-quality,~     lower-cost care for patients with critical illness endorsed by a collaborative of critical~     care societies. The investigators propose prompting consideration of functional outcomes.~     This trial will help establish the impact of the intervention on practice patterns including~     proxy engagement and elements of shared decision-making.~   "
25640|NCT02721576|"~     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in~     patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary~     objective (ORR) will be done as defined in the protocol.~   "
25623|NCT02721797|"~     Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective~     tissues, such as skin. EDS patients suffer from joint and skin problems (skin~     hyperextensibility, joint hypermobility) along with a large range of other disorders,~     including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility,~     gastrointestinal and gum problems. There are many different types of EDS, with different~     mechanisms of action, and not all of these are well understood. This study will used~     advanced microscopy techniques called atomic force microscopy (AFM) and scanning electron~     microscopy (SEM) to analyse the changes in collagen as a result of EDS, compared to normal~     collagen. These changes will be viewed at the micron and nanoscale level (between 1,000 to~     100,000 x magnification), and will focus on the differences in collagen construction through~     a process called cross-linking. These changes could potentially help clinicians understand~     the root cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in~     collagen. Increasing our knowledge of how collagen is affected in EDS patients, may lead to~     improved treatment options for patients.~   "
25624|NCT02721784|"~     The evaluation of the radiological changes in localised or locally advanced prostate cancer~     after androgen deprivation therapy and external beam radiotherapy using multi-parametric MRI~     (multi parametric magnetic resonance imaging) and VERDICT (Vascular, Extracellular and~     Restricted Diffusion for Cytometry in Tumours) sequences.~   "
25625|NCT02721771|"~     Preeclampsia remains a leading cause of maternal morbidity and mortality, in both the~     developed and developing world. It is a complex, multisystem disease which, in its severe~     form, affects the cardiovascular, renal, hepatic, neurological and haematological systems.~     The University of Cape Town-associated medical institutions alone were responsible for the~     treatment of 800 women in 2014, who were classified as having preeclampsia with severe~     features. Given the complexity of the disease, anesthetic management for Caesarean section~     in these patients remains very challenging.~      Recent studies have begun to demonstrate novel markers of preeclampsia severity, including~     point-of-care ultrasound (POC-US) and acid-base (AB) abnormalities. For example, pilot~     studies have demonstrated that approximately 25% of women diagnosed with severe preeclampsia~     show signs of increased intracranial pressure and elevated lung water as evaluated by point~     of care ultrasound. These findings could serve as noninvasive markers of disease severity,~     and thus may be used to predict maternal and fetal outcome in preeclamptic women. Point of~     care ultrasound is playing an increasing role in perioperative diagnosis, and newer, less~     expensive devices are continuously being developed, and will in all likelihood play an~     important role in South Africa in the near future.~      In a recent trial performed at the University of Cape Town, a comprehensive acid-base~     analysis in severe preeclamptic women demonstrated significant abnormalities in independent~     acid-base determinants. In addition, strong indications were found that changes in acid-base~     status in preeclampsia are more pronounced earlier in pregnancy and are associated with~     urgent deliveries. As in other clinical arenas in critically ill patients, acid-base~     abnormalities are associated with increased lung water, increased intracranial pressure, and~     outcome, and we hypothesize that similar associations might be found in severe preeclamptic~     women. Therefore, one aim of this study is to evaluate the association of venous acid base~     abnormalities (an inexpensive and readily available test) observed in late onset severe~     preeclampsia and organ manifestations identified with ultrasound, a well-validated and~     robust tool for identifying these manifestations. Investigators will further examine the~     association between ultrasound findings and/or venous acid-base abnormalities with urgent~     delivery. It is intended to do a subsequent comparison between early- and late onset~     preeclampsia, when a suitable tertiary site has been identified.~   "
25626|NCT02721758|"~     The purpose of this study was to test whether a brief motivational intervention is~     associated with enrollment in cardiac rehabilitation.~   "
25627|NCT02721745|"~     While the scientific community understands quite well why muscles ache after prolonged~     exercise, the origins of mental fatigue remain totally mysterious. Existing theories remain~     at a psychological level, with scarce supporting evidence. Mental fatigue typically occurs~     after long episodes during which humans exert control on motor or cognitive processes,~     instead of executing routine or stimulus-driven behaviours. However, work organization~     (especially in risky job like airplane control or medical profession) and pathologies due to~     an overload of work (like burn-out) seems to be directly linked to neural fatigue. One of~     the consequences of neural fatigue is to alter decision-making. As an example, the choice~     between an immediate monetary reward and a larger but delayed monetary reward (the so called~     intertemporal choices) are susceptible to fatigue state of its underpinning neural network.~      The investigators are proposing an exploratory study of neural fatigue, induced either in a~     natural way (by performing cognitive tasks for hours) or by transcranial stimulation, using~     three main physiological measures (Electro-encephalography to measure neural activity,~     indirect calorimetry to measure the metabolic cost of a cognitive effort, and pupillometry~     to measure cognitive effort).~      This study should allow to better understand the consequences of neural fatigue on cognitive~     functions like decision making as well as the associated physiological variables.~   "
25628|NCT02721732|"~     The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475)~     can help control the disease in patients with advanced cancer.~   "
25629|NCT02721719|"~     The cause of Inflammatory Bowl Disease (IBD) is not known, but studies from patients with~     IBD have found that these patients make unusually strong immune responses to their own~     intestinal tissues and to bacteria that normally live in the healthy gut. These overactive~     immune responses might result from an imbalance of T-lymphocytes, which are a type of white~     blood cell that recognize and respond to threats like infection or damaged tissues. In~     healthy tissues, a type of T-lymphocytes called T-regulatory cells control excess~     inflammation by preventing other T cells, called T-effector cells from responding. We~     believe that T-regulatory cells are somehow less active in IBD, resulting in damage to~     intestinal tissues by the T-effector cells.~      T-lymphocytes, including both T-regulatory and T-effector cells, are guided to different~     parts of the body by 'alpha4beta7-integrin' molecules. Vedolizumab or Entyvio works by~     blocking this homing molecule so that T cells do not reach the intestine, but stay in the~     blood where they cannot aggravate your IBD. This study will help in understanding how~     Vedolizumab helps to heal or decrease the symptoms of your Ulcerative Colitis.~      The effect of Vedolizumab on different types of T cells in the human intestine has not yet~     been studied. However, the investigators think that Vedolizumab will shift the balance of T~     cells in the intestine towards more healing T-regulatory cells and less damaging T-effector~     cells. The purpose of this study is to measure the different types of T cells in~     participants' blood and intestinal tissue before and during Vedolizumab treatment.~   "
25641|NCT02721563|"~     This is a perspective, multicenter,randomized controlledtrial,Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in~     patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary~     objective (ORR) will be done as defined in the protocol.~   "
25644|NCT02721524|"~     This study aims to compare whether De Vega's Suture annuloplasty is equally effective in~     reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring~     annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.~   "
25630|NCT02721706|"~     Objectives: To evaluate the cost-effectiveness of implementing a malnutrition screening tool~     CIPA at the Hospital Universitario Nuestra Señora de la Candelaria (HUNSC), comparing the~     impact on health and the healthcare costs of hospitalised patients who are screened for~     malnutrition and of patients following standard clinical practice. Methodology: The study~     will consist of a controlled trial on patients admitted to the Internal Medicine and General~     and Digestive Surgery wards at the HUNSC. In both wards patients will be randomised to a~     control or to an intervention group. The control group will follow usual hospital clinical~     care, while the intervention group will be administered the screening tool CIPA for early~     detection of malnutrition cases and they will be treated according to the screening results.~     The following variables will be evaluated: length of stay in hospital, mortality,~     readmissions and in-hospital complications. Cost-effectiveness analysis will be undertaken~     measuring effectiveness by Quality-Adjusted Life Years (QALYs). Cost per patient will be~     measured by identifying health care resource utilisation, and the cost-effectiveness measure~     will be the Incremental Cost-Effectiveness Ratio (ICER). Investigators will calculate the~     incremental cost per QALY gained related to the intervention. This analysis will allow to~     quantify the costs (incurred and saved) related to the introduction of the malnutrition~     screening tool CIPA in the hospital context and to measure the health impact of screened~     patients.~   "
25631|NCT02721693|"~     The primary purpose of the study is to investigate if physical exercise is associated with~     myocardial damage, expressed by elevated troponin T, in patients with COPD.~   "
25632|NCT02721680|"~     The goal of the proposed project is to provide the Army with a brief, well-validated,~     internet-based training program for enhancing Awareness Training and resilience skills. This~     project will address the needs outlined for the Military Operational Medicine Research~     Program, particularly with regard to enhancing Psychological Health and Resilience. The~     fundamental approach of the project directly addresses the need to develop psychological~     resilience among Service members and families to promote well-being and prevent behavioral~     health outcomes. Addressing this need is crucial, as military personnel are often required~     to serve under dangerous and emotionally stressful conditions. Prolonged stress or exposure~     to very intense life threatening experiences, such as those encountered in combat or other~     hazardous duty deployments can increase the risk of developing mental health problems~     including depression, anxiety, or post-traumatic stress disorder (PTSD). One possible way to~     minimize the effects of these stressful experiences on Service members is to strengthen~     their emotional flexibility, adaptability, and capacity to cope with adversity before they~     find themselves faced with such situations. To fill this need, the investigators propose to~     provide the military with a web-based program that focuses on enhancing Awareness Training,~     a core set of trainable awareness skills that collectively include the capacity to~     understand, perceive, control, and use emotions effectively.~      While the previous pilot program was successful in some ways, it needs further research~     before it is ready for widespread use. The investigators therefore propose to build upon the~     existing strengths already in the program and redesign the weaker modules to be more~     effective. Over the course of a four-year study, the investigators propose to develop this~     program. The proposed Awareness Training program is brief, web-based, easily accessible, and~     sufficiently focused such that it could be completed by large numbers of military personnel~     with minimal time burden, leading to rapid enhancement of awareness skills. Such a program~     could have a significant effect in promoting resilience, interpersonal functioning, and~     brain health among Service members and their families, while reducing the likelihood of~     mental health problems among those returning from exposure to potentially traumatic~     experiences.~      The central hypothesis is that a set of well designed and targeted training modules~     addressing core awareness ability domains will significantly enhance measured awareness~     skills, will translate into improved performance on militarily relevant metrics, and will~     lead to better mental and emotional health, as well as well being during stressful~     situations and subsequent cognitive processing.~   "
25633|NCT02721667|"~     Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension~     are at high risk for cardiovascular disease and death. Most of this risk is mediated through~     high blood pressure (BP). However, seniors are also at risk for side effects from BP~     lowering medication. These can be life threatening and costly. Therefore, BP monitoring is~     required to ensure BP levels are in the recommended range (neither too high nor low).~      Home BP monitoring can be used to ensure that BP is in the right range and is recommended~     for all patients with high BP. Studies in other health care systems show that, to optimally~     perform home monitoring, the readings should be teletransmitted (electronically sent to the~     care provider). Additional studies indicate that BP control improves when health care~     providers (usually pharmacists or nurses) are specifically assigned to review~     teletransmitted BP readings and, using protocols, make therapeutic adjustments. However, a~     study needs to be conducted within the Canadian healthcare system to prove that~     telemonitoring±case management is cost-effective. In addition, proof that seniors consider~     telemonitoring to be usable and acceptable is required.~      The investigators will conduct a 200 patient randomized trial in community-dwelling seniors~     that will compare home BP monitoring alone to telemonitoring plus case management, to~     comprehensively assess cost-effectiveness, usability, and acceptability. Our partners~     include TeleMED, a medium sized Canadian technology company with a wealth of experience in~     medical data management and transmission; Pharmacare, which will provide case-management~     services. The study will take place in seniors' supportive living residences; by virtue of~     residing in these institutions, these seniors have complex care needs. This intervention, if~     effective, cost-effective and safe, can be widely implemented.~   "
25634|NCT02721654|"~     The aim of PLUS is to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to~     determine whether fluid resuscitation and therapy with a balanced crystalloid solution~     (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid~     resuscitation when compared with the same treatment using 0.9% sodium chloride (saline)~   "
25635|NCT02721641|"~     This study evaluated the long-term safety of treatment with trastuzumab in participants with~     metastatic or locally advanced cancer with human epidermal growth factor 2 (HER2)~     overexpression who had completed a prior study with trastuzumab.~   "
25636|NCT02721628|"~     Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus~   "
25637|NCT02721615|"~     About a thousand people a year in the United Kingdom survive a spinal cord injury but are~     left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims~     is more than half a billion pounds. We propose that after spinal cord injury, cord pressure~     at the injury site rises, damaging the spinal cord further by secondary ischaemia. The value~     of measuring and reducing cord pressure after spinal cord injury is unknown.~      The injured spinal cord is compressed by bone malalignment and cord swelling. Current~     management involves realigning and fixing the bony fragments using metal screws, rods and~     plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the~     swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty~     reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised~     hypothermia reduces intra spinal pressure and improves metabolism.~      We will develop a novel method to measure cord pressure and metabolism at the injury site~     after spinal cord injury and determine whether the cord pressure rises, for how long, and~     with what impact on spinal cord metabolism.~      This is a pilot study to find out whether spinal cord pressure and metabolism can be~     measured after spinal cord injury and whether they are effected by treatment choices.~   "
25642|NCT02721550|"~     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with preoperatie concurrent~     chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma .~     Analyses of primary objective (pathologic Complete Response) will be done as defined in the~     protocol.~   "
25645|NCT02721511|"~     This is a, prospective, single center, open-label, pilot study to evaluate the safety and~     efficacy of the subcutaneous administration of a novel furosemide formulation. The results~     of this pilot study will be reviewed to determine the safety of the subcutaneous treatment~     regimen and to evaluate patient selection criteria for possible at home treatment. The~     intent is to conduct a future follow on study looking at the feasibility of at home~     treatment of patients referred to a hospital for treatment of fluid overload.~   "
25646|NCT02721498|"~     This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF)~     patients from the Royal Brompton Hospital, London investigating outcome measures used in~     airway clearance trials.~      Each participant will attend the research facility for two visits. Participants will be~     randomly assigned to the order that they perform the study sessions. Visit A will involve a~     period of rest for up to 60 minutes in-between assessments; Visit B will involve a session~     of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult~     CF.~      Participants will perform the outcome measure (OM) tests of impulse oscillation system~     (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a~     supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the~     session. IOS, LCI and spirometry will be repeated after the session. Sputum will be~     collected throughout the ACT or rest sessions and for 30 minutes after each of these~     sessions is completed. Questionnaires asking patient views on the OMs will be completed at~     the end of each study visit.~      Analysis will be based upon differences in outcome measures and in-between study days.~   "
25647|NCT02721485|"~     Salt fluids are used extensively for acutely ill patients who are admitted to hospital. Two~     salt fluids commonly used are Normal Saline and Ringer's Lactate. Both are used to rehydrate~     patients, restore fluid volume and help stabilize blood pressure and failing organs. Both~     salt fluids have been used for several decades. Until recently, it was thought the fluids~     are essentially equivalent other than some minor differences related to the concentration of~     salt components (sodium and chloride) and buffers (Ringer's Lactate has lactate as a~     buffer). Recent data suggest that salt fluids containing less chloride like the Ringer's~     Lactate, cause less acid in the blood, less kidney failure, and less death. However, the~     studies to date are small and weak in their design and it is possible that there are no~     important differences that affect patients. Hence, the research team will conduct a robust~     pragmatic clinical trial where several academic and community hospitals will be randomized~     to use either Ringer's Lactate only or Normal Saline only for a period of three months. The~     trial will yield high quality and robust data to determine if Ringers Lactate reduces death~     and re-admissions to hospital. Before embarking on this large-scale trial, it is important~     to conduct a smaller (pilot) trial to evaluate if the larger trial will be feasible and not~     too costly. In this small trial involving no less than 4 hospitals, the investigators will~     determine how well the fluid interventions are adhered to in each hospital, record how long~     it takes to receive approval from research ethics boards and be ready to start the study.~     The investigators will also record challenges and develop solutions related to the~     operations of the trial, and describe important clinical and outcome data essential for the~     design and planning of the large trial.~   "
25648|NCT02721472|"~     The purpose of this study is to evaluate the relationship between plasma DNA levels and~     micro- and macro-circulatory vascular remodelling in patients with sickle cell disease~   "
25649|NCT02721459|"~     The main purpose of this study is to determine the maximum tolerated dose (MTD) and~     recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus~     cobimetinib in participants with BRAF V600 mutated melanoma and to evaluate the safety and~     tolerability of this combination.~   "
25650|NCT02721446|"~     The purpose of this study is to find out which types of written stroke messages may help~     high risk stroke patients take action to improve their health.~   "
25651|NCT02721433|"~     The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs.~     4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal~     events within the Canadian Health Care System. This study will use an integrated consent~     model that involves oral consent rather than a written informed consent writing process~     as the study is comparing standard schedules and not a new administration schedule.~   "
25652|NCT02721420|"~     Background and rationale: Children hospitalised with severe anaemia in Africa are at high~     risk of readmission or death within 6 months after discharge. No strategy specifically~     addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria~     chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL)~     in children with severe malarial anaemia prevented 31% of deaths and readmissions. The~     effect was in addition to the effect of insecticide-treated bednets. There is now need to~     design and evaluate effective delivery mechanism for PMC within the health system.~   "
25653|NCT02721407|"~     The goal of this clinical trial is to study the feasibility and efficacy of~     anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating~     recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells.~     Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically~     against cancer cells, has emerged as a promising therapeutic strategy. Among the many~     emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell~     malignancies have demonstrated remarkable potential. CARs combine the variable region of an~     antibody with T-cell signaling moieties to confer T-cell activation with the targeting~     specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to~     MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the~     persistence and efficacy of CAR-T cells are still restricted by the target selection.~     Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells,~     which preferentially become refractory or resistant due to the heterogeneity of lymphoma.~     This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more~     effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.~   "
25664|NCT02721264|"~     Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior~     histological evidence of steatosis or steatohepatitis admitted under the Department of~     Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and~     who provide informed consent will be included in the study.~   "
25654|NCT02721394|"~     The current project aims to assess the feasibility of conducting Functional Communication~     Training in the UK with a small sample of young children (aged under 9) in an NHS setting.~     Two delivery formats will be assessed in order to demonstrate the feasibility of conducting~     FCT via different delivery methods within an NHS context. Participants will be four children~     aged under 9 who have an identified intellectual / developmental disability and display~     either self-injury, property destruction, or aggression at home. In addition, one family~     carer per child will be coached to implement the intervention, either following researcher~     intervention, or from the beginning. Data will be collected on challenging behaviour,~     communication responses, family carer confidence in managing behaviour, fidelity of~     intervention implementation, family quality of life, and acceptability of the intervention.~   "
25655|NCT02721381|"~     The specific objectives of this project are to conduct a randomized control trial to examine~     the effect of a novel, telehealth parent training intervention for children with autism~     spectrum disorder (ASD), ImPACT Online, on parent and child outcomes. The investigators will~     compare the benefits of the self-directed and therapist-assisted delivery formats, and~     examine moderators and mediators of treatment outcomes. The investigators anticipate that~     both the self-directed and therapist-assisted models of ImPACT Online will be effective~     methods for teaching parents to use evidence-based intervention strategies and for~     increasing parent self-efficacy compared to a web-based information control group.~     Participants will be randomly assigned to one of three groups. One-third of participants~     will be in the therapist-assisted group; one-third will be in the self-directed group; and~     one-third will be in a web-based information control group.~   "
25656|NCT02721368|"~     The purpose of this study is to determine whether Neuramis® Volume Lidocaine is effective in~     the temporary restoring the mid-face volume.~   "
25657|NCT02721355|"~     H. pylori positive patient volunteers that passed the selection criteria are recruited and~     divided into a test and a control group. Both groups are treated with a current treatment~     regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day)~     but only the test group received IgY-containing food supplement as an adjunctive measure for~     15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea~     Breath Test (UBT) and gastro-endoscopy.~   "
25658|NCT02721342|"~     Most chronic kidney diseases have a progressive evolution characterized by the gradual loss~     of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin~     synthesis and activation of vitamin D. On many occasions, the progressive deterioration of~     renal function occurs, even when the etiologic factors responsible for the kidney disease~     are treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and~     fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and~     increased urine protein excretion, being both risk factors of progression toward kidney~     failure. Many clinical studies have shown the efficacy of antihypertensive therapies,~     particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein~     excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal~     function decline and in some cases even lead to recovery of kidney function avoiding the~     need for renal replacement therapies. The set of measures to achieve these results~     encompasses the term of renoprotective therapy. However these achievements have been~     obtained in the setting of clinical trials, and need confirmation in the daily clinical~     practice.~      To this purpose a standardized multidrug intervention model that aims at normalizing the~     excretion of urinary proteins and stabilizing the renal function has been developed for the~     outpatient-clinic and named Remission Clinic.~      The applicability of this protocol is aimed for all nephrology and diabetology centers.~     Through the use of a dedicated database computer network, it will be possible to share~     clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission~     Clinic program. With this system, it will be possible to verify if the multidrug approach of~     the Remission Clinic will allow to improve the clinical course of chronic proteinuric~     nephropathy. All participants (centers) may access to the Remission Clinic website~     developed, updated and maintained by the Department of Bioengineering of the Mario Negri~     Institute, Bergamo, Italy.~   "
25659|NCT02721329|"~     The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP~     without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and~     Insomnia.~   "
25660|NCT02721316|"~     To evaluate the impact of a specific nursing management (personalized and close, through~     consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the~     suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt~     in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.~   "
25661|NCT02721303|"~     This study plans to learn more about how age and weight impact appetite and food intake.~     Specifically, this study is being done to see whether age and obesity impact appetite and~     the brain's response to food. In this study the investigators will be evaluating how~     participants brains respond to food images as well as your food-related behaviors and~     hormones. The investigators will be comparing older individuals aged 65 to 85 years who are~     normal weight compared to those who are obese. The Investigators will then compare older~     aged individuals to younger adults aged 21 to 45 years.~   "
25662|NCT02721290|"~     In this study, we will be comparing two approaches to the femoral block. The first or~     classical approach and one that is the most popular in our institution is used by combining~     ultrasound guidance and neurostimulator to do the block. The second is performed with the~     ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle~     and injecting. The primary endpoint of the study is the sensitive cutaneous block~     distribution using both techniques.~   "
25663|NCT02721277|"~     Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants~     unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or~     function. In early PN-associated cholestasis, the dose of traditional soy based lipid is~     limited to 1 g/kg/day which often limits the growth capacity of parenteral~     nutrition-dependent infants. Inadequate growth is directly related to poor neurological~     outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's~     already damaged intestine. Ultimately, these outcomes can lead to severe disability and~     death. To mitigate these deleterious effects and optimize growth, parenteral~     nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of~     soy-based lipid emulsion must have a greater intake of lipids to meet their needs for~     weight, length, and head circumference growth.~      SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides~     essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less~     susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain~     triglycerides which show a faster metabolic clearance than long-chain triglycerides, and~     fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and~     soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic~     infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day.~     Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of~     the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty~     acid requirements. Its use in situations in which growth is inadequate in babies who must be~     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly~     increase their chances of both a good neurological outcome and survival.~      The aim of this research study is to determine if the unique formulation of SMOFLipid will~     cause less hepatic inflammation compared to soy only intralipids.~   "
25665|NCT02721251|"~     Obstructive sleep apnea (OSA) is highly prevalent among Veterans, and is associated with~     significant mortality and multiple morbidities. Available treatments have had limited~     effectiveness in treating OSA and alleviating associated morbidity. The investigators'~     previous research found a reduction in OSA severity of approximately 25% following modest~     exercise training. That this effect occurred independent of weight loss raises the exciting~     possibility that exercise combined with weight loss could reduce OSA by at least 50% and~     have unique health benefits for OSA patients. Following screening and baseline assessments,~     90 overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week~     treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss.~     Changes in OSA and related morbidity will be compared between treatments.~   "
25666|NCT02721238|"~     Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary~     Sciences with documented or suspected sepsis induced hypotension will be randomized to~     receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At~     admission, all patients will undergo physical examination and baseline investigations to~     identify site of sepsis. The aim of study is to compare the efficacy of using 20% human~     albumin versus plasmalyte in resuscitation of the patient that is attainment of mean~     arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean~     arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered~     20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the~     intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence~     of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after~     one week will be studied.~   "
25667|NCT02721225|"~     More than 20 million infants worldwide, representing 16 per cent of all births, are born~     with low birth weight, 96 per cent of them in developing countries. Bangladesh having one of~     the highest incidence rate (21.6%) in the world.The short-term consequences of LBW is 12~     times higher perinatal mortality. It is estimated that LBW causes 60 to 80 % of neonatal~     deaths. For the survivors, the effects are long lasting and largely irreversible. Infants~     born LBW are at 2-4 times greater risk to develop acute diarrhea, pneumonia or acute~     respiratory tract infection than their normal birth weight counterparts. Adults born with~     LBW suffer increased risk of high blood pressure, coronary heart disease (CHD), non insulin~     dependent diabetes mellitus, obstructive lung diseases, or renal damage.~      Genitourinary (GU) infection, as a major risk factor for low birth weight deliveries~     affecting a very large number of women both in the industrialized and the developing world.~     In Bangladesh, there was a high incidence of UTI in 21-25 years age group (44.61%). The~     bottom line for GU infection is that lactobacilli, healthy bacteria lose their dominant.~     Recently, the protective role of the commensal microbiota has come into focus for its~     infection-inhibiting function. Lactobacilli that colonize the gastrointestinal tract or~     vagina can either significantly modulate the colonic microbiota by increasing the number of~     specific prebiotic bacteria such as lactobacilli and bifidobacteria or reducing undesired~     intestinal colonization of pathogenic bacteria. Prebiotic like Fructooligosaccharide (FOS)~     is known to promote growth of normal healthy flora like lactobacilli (LAB). FOS~     supplementation in early pregnancy improves vaginal or gut microflora with LAB , which will~     control GU infection and improve pregnancy outcome and promote infant's growth and~     development~   "
25668|NCT02721212|"~     54 inpatients participants were randomly divided into two groups (experimental and~     conventional). Individual of experimental group were treated according to an established~     protocol for ARMEO Spring (30 minutes/session with Armeo Spring and 30 minutes/session~     with conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of~     passive and active assisted mobilization of the upper limbs, traditional training based on~     the Bobath concept. Inpatients of control group were treated with conventional treatment~     with training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by~     a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and~     at follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional~     Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified~     Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).~   "
25669|NCT02721199|"~     Acute exacerbations of COPD contribute to significant morbidity and mortality in the United~     Kingdom (UK). The ability to assess response to treatment during exacerbations that require~     hospitalisation would allow clinicians to better risk stratify patients for higher or lower~     level in-patient or out-patient care. Current methods of detecting clinical deterioration~     are validated in general medical populations and may lack sensitivity and specificity in~     patients with respiratory morbidity. The use of respiratory muscle EMG to assess neural~     respiratory drive (NRD) has been demonstrated to be a predictor of readmission in patients~     admitted to hospital with COPD. The technique has been applied on 'spot' readings of limited~     duration due to the need for hand analysis of the data. It has been performed by a trained~     clinical physiologist who removed any interference data and standardised the data gathered.~     New automated software allows for longer periods of observation, mostly unsupervised, and as~     a result, the NRD measurements are more likely to be affected by various sources of~     variability. The influence of clinical and physiological factors as they occur during~     routine clinical management, such as administration of bronchodilator medication, time of~     day of readings or proximity to chest physiotherapy, are not yet understood. This trial is~     designed to gather data to better understand these relationships with NRD.~   "
25670|NCT02721186|"~     The overall aim of this study is to determine the effectiveness of two rounds of mass drug~     administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD)~     primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on~     Unguja Island, Zanzibar.~   "
25671|NCT02721173|"~     The combination therapy of retinoid and clindamycin for acne is preferred because it targets~     multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby~     improving outcome. Literature review reveals that till date there is no published~     comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene~     plus clindamycin. So the present study has been designed to compare these two combination~     therapy in acne vulgaris.~   "
25684|NCT02721004|"~     This is an open-label, non-interventional study to evaluate efficacy and safety in~     rheumatoid arthritis participants receiving tocilizumab as per the product label.~   "
25685|NCT02720991|"~     A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of~     sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.~   "
26077|NCT02715817|"~     The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and~     therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the~     balance of poststroke hemiparesis patients and the impact on quality of life.~   "
25672|NCT02721160|"~     The government of Burundi is implementing a new financing scheme in health centres. The~     objective is to provide additional financial compensations to health centres on the basis of~     their performance in nutrition activities: it consists in the introduction of criteria~     focusing on malnutrition prevention and care activities in the existing performance based~     financing (PBF) system.~      The general objective of this study is to assess the effects of this new financing scheme,~     to document its impact and to study the chains through which it occurred. This study will~     provide key evidence for countries with an existing PBF scheme and confronted with~     malnutrition problems on the appropriateness to extend the strategy to nutrition services.~     If this impact evaluation brings positive results, this may have implications for the global~     fight against malnutrition.~   "
25673|NCT02721147|"~     The central goal of this study is to examine the feasibility, acceptability, and preliminary~     efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes,~     and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility,~     acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers~     exist that limit participation in intensive sexual QOL interventions for breast cancer~     survivors, an innovative secondary aim will investigate the perspectives of study-eligible~     patient candidates who opt out of participating in the pilot trial. We expect that we will~     be able to identify the participation barriers and intervention preferences of breast cancer~     survivors with sexual concerns who opt out of the intensive trial in order to inform the~     development of different interventions for future study.~   "
25674|NCT02721134|"~     Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and~     prompt implementation of the etiological treatment. The bacterial infections are the most~     common and are associated with high morbidity and mortality. Diagnosis is based on the~     detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor~     antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often~     based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination~     of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During~     sepsis, gram + and gram - are circulating and often present in small amounts; they can be~     detected by sensitive and specific tools following a pretreatment of the blood sample~     (innovative technology Bacti-DIAG).~      The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a~     suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary~     objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams)~     in the patient's care including diagnosis and treatment.~      All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome~     (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care~     of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of~     sepsis or SIRS be confirmed retrospectively by two independent experts blinded to~     Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be~     calculated and associated detection limits will be determined to meet the objectives of the~     study.~      It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and~     analyze biometric and biological data based on the subsequent evolution of the patients. The~     care of patients will be blinded to the results of the new biomarker Bacti-DIAG~   "
25675|NCT02721121|"~     The purpose of this study is to compare the clinical outcomes depending on catheter ablation~     strategy for persistent atrial fibrillation. After randomization, investigators will conduct~     circumferential pulmonary vein isolation alone in a group, and additional posterior box~     isolation and anterior linear ablation in the other group. Investigators will compare~     clinical recurrence rate, complication rate, and procedure time, etc.~   "
25676|NCT02721108|"~     Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on~     women's lives and the (National Health Service) NHS.~      CPP may be related to internal organs, the nervous system or psychological factors and is~     often difficult to treat. Surgery and drugs have risks and side effects, are expensive and~     do not help all patients.~      Psychological treatments have potential to improve CPP but are not consistently available.~     Mindfulness meditation teaches people to accept their sensations and emotions in the present~     moment. This can help to accept pain better, which enables patients to focus on daily~     activities and improve their quality of life. It has been shown to help in headache, back~     pain and depression. Usually mindfulness meditation is taught by attending courses for 8~     weeks.~      The investigators want to find out in a full-scale trial if mindfulness meditation, taught~     by using a smartphone app, can help CPP patients.~      In preparation for this full-scale study the investigators will conduct the MEMPHIS study to~     answer the following questions:~        -  How many patients are willing to participate?~        -  How often they use the app?~        -  Reasons for not wanting to participate/not using the app -~           - Which health questionnaires are the most useful ones?~        -  How many patients will be required for the full-scale trial?~      Patients will receive the usual treatment and be divided into three groups~        -  using a 60-day mindfulness meditation app,~           -- using comparison app with progressive muscle relaxation but no meditation~        -  no app~      Patients will complete health questionnaires, may be asked to comment in a focus group and~     record pain, medication changes, surgery and emergency medical visits~   "
25677|NCT02721095|"~     evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl~     compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting~     hypokalemia~   "
25678|NCT02721082|"~     The purpose of this study is to determine the impact and efficacy of a new approach to~     smoking cessation treatment versus the traditional approach.~   "
25679|NCT02721069|"~     This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1~   "
25680|NCT02721056|"~     The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of~     NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and~     activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.~   "
25681|NCT02721043|"~     The purpose of this study is to test the safety, tolerability, and immunogenicity of~     Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic~     malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence.~     Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These~     peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant~     Poly-ICLC is added to boost the immune response to the peptides and together will expand~     immune cells to target cancer.~   "
25682|NCT02721030|"~     This is a prospective cohort to describe clinical characteristics, predictors of poor~     outcomes both during hospitalization and at home, functional status, and quality of life~     among patients aged 13 years or more, consecutively admitted with acute decompensated heart~     failure at Mbarara Regional Referral Hospital.~   "
25683|NCT02721017|"~     The purpose of this study is to determine whether cryoanalgesia provides better pain control~     for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.~   "
25686|NCT02720978|"~     Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of~     8-10% of births. Since the duration until delivery is important in avoiding the risk of~     complications, several studies have been performed in order to understand what is the~     preferred way to manage this condition of PROM in women that are not in active labor. In the~     largest random study that has been performed 20 years ago, there was found an advantage for~     labor induction with oxytocin over labor induction with Prostaglandin or waiting. However,~     the most important component - the BISHOP score, that affects the decision of the labor~     induction way, was not reported and was not taken into consideration.~   "
25687|NCT02720965|"~     The main objective of this study is to compare the efficacy of continuous nerve blocks with~     single injection in terms of perioperative patient satisfaction after scheduled orthopedic~     ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients~     Pain Catastrophizing Scale (PCS) and type of surgery.~      Secondary objectives comprise the assessment of pain, readmission rates, patient~     mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about~     quality of recovery will be performed on day 1, about quality of life on day 45 and presence~     of neuropathic pain will be screened at 3 months. An economic study will also be conducted,~     including work resumption at 3 months.~      This is a multicentric prospective study. Three hundred patients will be randomized in two~     parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump~     versus single local anesthetics injection.~      The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary~     endpoints will include assessment of pain, opiates consumption, sensitivity and motricity~     scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep~     and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of~     Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain~     assessment (DN4) at day 90.~   "
25688|NCT02720952|"~     The study will be conducted in a total of 24 subjects before their 6th birthday, requiring~     replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or~     hypopituitarism.~      The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged~     between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2~     years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only~     if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be~     enrolled (Cohort 3).~      The decision to continue after each cohort will be based on the recommendation of an~     Independent Data Monitoring Committee (IDMC).~   "
25689|NCT02720939|"~     Specific Aims:~        1. To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear~          cells (PBMCs) isolated from whole blood of ASD probands and healthy controls.~        2. To derive neural progenitor cells (NPCs) and neurons from iPSCs of ASD probands and~          healthy controls and compare differences between patients and healthy controls to~          investigate the cellular phenotype of ASD and uncover the pathophysiology of the~          disease.~   "
25690|NCT02720926|"~     Standard 3+3 dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal~     and colorectal cancer.~   "
25691|NCT02720913|"~     The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace~     suture tying with a faster procedure during surgery. While preclinical studies confirmed the~     speed of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture~     fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots.~     COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is~     important to quantify the time-saved by application of this technology.~   "
25692|NCT02720900|"~     The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota~     and metabolites in children with autism spectrum disorders.~   "
25693|NCT02720887|"~     The nanoparticles (NP) are defined as particles whose size is no greater than 100~     nanometers. However, their impact on health remains little evaluated.~      Placental transfer of NP has been proven in many studies in vitro and in vivo in animals,~     and toxicity in the fetus has been studied in many animals. The investigators seem~     interesting at first to establish the mineralogical load in the amniotic fluid in humans.~      The first objective of this study is to determine the mineralogical NP load, quantity and~     composition, in the amniotic fluid in pregnant women.~   "
25694|NCT02720874|"~     This research will evaluate a multifaceted patient-centered intervention in a sample of~     socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that~     capitalizes on a partnership between the extended rheumatology healthcare team and each~     patient in order to promote understanding, uptake and adherence to the principles of~     treat-to-target strategy. The primary hypothesis of this study is that the addition of a~     multifaceted intervention incorporating integrated multidisciplinary rheumatologic care,~     nurse-directed self-management education and supportive follow-up, and technology-based at~     home RA symptom monitoring and reporting to clinical guideline-based care will increase RA~     remission rate at 6 months.~   "
25695|NCT02720861|"~     To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in~     non-cardioembolic ischemic cerebrovascular disease in Thai patients.~   "
25696|NCT02720848|"~     This is a randomized clinical trial examining the use of a stiffening wire to increase depth~     of maximal insertion during double and single balloon enteroscopy.~   "
25733|NCT02720354|"~     [11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open‑label, Safety and~     Tolerability, Radiation Dosimetry, Biodistribution, First‑in-Human Study of a Novel~     11C‑labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging~   "
25734|NCT02720341|"~     Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the~     ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke,~     spinal cord injury)~   "
25782|NCT02719717|"~     This research program consists of a prospective, multi-institutional Phase 2 trial and an~     economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy~     compared to traditional techniques.~      It will be left up to the study credentialed surgeon investigator to decide the suitability~     of PA branches for sealing. This will be decided intra-operatively based on anatomy,~     vascular dissection and length as well as patient specific factors.~   "
25697|NCT02720822|"~     Breathlessness is an overwhelming symptom affecting tens of thousands of Australians every~     day. For many people, it persists even when all the underlying causes have been optimally~     managed (chronic breathlessness). In these circumstances, it often occurs at rest or with~     minimal exertion.~      Evidence from a number of clinical studies suggests that a small, regular dose of morphine~     helps to reduce safely the sensation of breathlessness. However, it is not well established~     which patients derive more benefit and what is the net clinical effect of this treatment~     (weighing benefits and harms).~      This is a phase III, multi-site, randomised, double-blind, placebo-controlled trial with~     patients with chronic obstructive pulmonary disease (COPD) and severe chronic breathlessness~     which will explore several important questions:~        -  Are regular, low doses of morphine at four possible doses over 3 weeks more effective~          than placebo at improving breathlessness?~        -  Does increasing the dose in people who already are experiencing some benefit provide~          even greater reduction in worst breathlessness?~        -  Does the medication have any effect on daily activity and quality of life?~        -  What are the common or serious side effects of this intervention?~        -  Does the benefit from the medication outweigh the side effects it produces?~        -  Are there specific characteristics of people who are more likely to receive benefit~          from extended release morphine?~      Participants will receive once daily extended release morphine (plus laxative, docusate with~     senna), or placebo (placebo laxative) in addition to their usual medication for up to 3~     weeks at increasing doses.~      Participants will have a medical interview and physical examination to collect some general~     health information, and baseline measurements including; daily activity, symptoms, and~     quality of life. A small amount of blood may be required to check eligibility. Further blood~     samples may be taken at week 1 and 3 to enable testing on how individuals respond to~     opioids, further consent will be obtained for these samples.~      Data on benefits, side effects, and medical care will be collected during comprehensive~     weekly visits. Participants will also fill out a simple diary twice daily for weeks one to~     three of the study, and for one day each week during an optional 3 month extension stage.~      The outcome of this study may enable better management of symptoms and activity in people~     COPD with medicines that are shown to be effective and safe.~   "
25698|NCT02720809|"~     Health2016 is a general population cross-sectional study aimed at completing af monitoring~     program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar~     studies have been performed in 2006, 2010, and 2013.~   "
25699|NCT02720796|"~     Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived~     xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The~     purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX)~     model in predicting patient clinical response to the same drug treatment.~   "
25700|NCT02720783|"~     The primary objective of the study is to evaluate the local tolerability of the new~     Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone~     products and placebo. Pharmacokinetics of the study products after single and multiple~     applications o.d. for 3 days, overall local and general tolerability, safety and comfort of~     use will also be evaluated.~   "
25701|NCT02720770|"~     This study evaluates the effect on height of a two year treatment with growth hormone in 19~     children with X linked hypophosphatemic rickets.~   "
25702|NCT02720757|"~     The primary objective of this NIS is to measure changes in physical functioning, a surrogate~     for physical activity and exercise capacity, in COPD patients on treatment with Spiolto®~     Respimat® in routine daily treatment after approximately 6 weeks.~      A secondary objective is to evaluate the patient's general condition (physician's~     evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit~     at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction~     with Spiolto® Respimat® at Visit 2.~   "
25703|NCT02720744|"~     The purpose of this study is to determine whether FT218 is safe and effective for the~     treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.~   "
25704|NCT02720731|"~     The combination of motor disabilities, chronic pain, cognitive disabilities limiting the~     possibilities of communications and repeated potentially painful rehabilitation, exposes~     patients with motor disabilities to a high risk of induced pain in the specialized~     establishments. Induced pain is difficult to detect and is therefore little assessed and~     treated. Currently, little is known about the prevalence and conditions of occurrence of~     such induced pain as the clinical characteristics of patients (children, adults, severity of~     disability), the types of care and the nature of the institutional admission (medical or~     medico-social). Secondary objectives are to identify risk factors related to the induced~     pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain~     assessment tool in a routine clinical set-up.~      All daily life procedures or treatment carried out in children and adults with motor~     disability are collected for 5 days and 1 night. Collected data are clinical and demographic~     characteristics of patients, the intensity of the pain assessed by the care professional~     (FLACC-r) or the patient himself (VAS).~      Clinically, the uncomfortable and painful procedures and risk factors for pain identified by~     this study will help the development of targeted preventive measures within institutions.~     Meanwhile, the study should sensitize Breton teams involved with regards to the induced~     pain, leading them to observe the behavior of patients, to admit any pain related to an act~     of daily life, and to ask for the medical profession to anticipate the painful experience.~   "
25705|NCT02720718|"~     Background~      Excess weight and obesity is the fifth leading risk factor for global death. Bariatric~     surgery is considered as the only effective long-term treatment for morbid obesity.~     Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it~     achieves excellent long-term results with a low complication rate. Intestinal anastomosis is~     a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties~     of knotting the suture in a limited working area. Barbed sutures may enhance this procedure~     by eliminating the need for knot tying.~      Objective The aim of this study is to compare the safety and efficacy of knotless barbed~     sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and~     jejunojejunal anastomosis in obese patients undergoing gastric bypass.~      Study design~      This is a prospective randomized study. Patients will be randomly assigned to one of two~     groups: traditional suture group or knotless suture group. Randomization will be realized by~     sealed envelopes according to a computer-generated sequence of random numbers, which will be~     opened for the surgeon just before starting the anastomosis. During the surgery the~     gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45~     Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional)~     suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass~     technique, will perform all procedures.~      Study population~      Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass.~      Main study parameters/endpoints~      The primary outcome measure will be the rate of anastomosis-related complications (leakage,~     bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op~     (safety). The secondary outcome measure will be the time spent on closing the gastrojejunal~     and jejunojejunal anastomosis (efficacy).~   "
25706|NCT02720705|"~     The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in~     preschool children undergoing tonsillectomy operations in the prevention sevoflurane~     agitation.~   "
25707|NCT02720692|"~     The primary objective of this study is to evaluate the safety and tolerability of N1539 in a~     variety of post-surgical conditions.~   "
25766|NCT02719925|"~     The goal of clinical trial is to evaluate the effect of one month of consumption of mineral~     water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy~     consumers having magnesium daily intakes below the recommended dietary allowance (RDA).~   "
25708|NCT02720679|"~     The purpose of this study is to collect and store samples and health information for current~     and future research to learn more about the causes and treatment of blood diseases. This is~     not a therapeutic or diagnostic protocol for clinical purposes. Blood and bone marrow as~     well as health information will be used to study and learn about blood diseases by using~     genetic and/or genomic research. In general, genetic research studies specific genes of an~     individual; genomic research studies the complete genetic makeup of an individual.~      It is not known why many people have blood diseases, because not all genes causing these~     diseases have been found. It is also not known why some people with the same disease are~     sicker than others, but this may be related to their genes. By studying the genomes in~     individuals with blood diseases and their family members, the investigators hope to learn~     more about how diseases develop and respond to treatment which may provide new and better~     ways to diagnose and treat blood diseases.~      Primary Objective:~        -  Establish a repository of DNA and cryopreserved blood cells with linked clinical~          information from individuals with non-malignant blood diseases and biologically-related~          family members in order to conduct genomic and functional studies as outlined in the~          secondary objectives.~      Secondary Objectives:~      Utilizing the biorepository, investigators aim to:~        -  Identify novel mutations that associate with disease status in individuals with~          unexplained non-malignant blood diseases.~        -  Identify modifier genes in individuals with defined monogenic non-malignant blood~          diseases.~        -  Identify genetic variants associated with treatment outcomes and toxicities for~          individuals with non-malignant blood disease.~   "
25709|NCT02720666|"~     This study is an open and single-center Phase I clinical research on patients with advanced~     pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to~     determine the safe and reasonable dosage and dosing regimen.~   "
25710|NCT02720653|"~     Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which~     affects 12.5% of the adult population across all racial and ethnic groups. Previous research~     has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with~     complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals~     in the United States with chronic rhinosinusitis. This proposed investigation will be used~     to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain~     insights into mechanisms of olfactory dysfunction in this population.~   "
25711|NCT02720640|"~     The aim of this single-centre study is to assess the safety and efficacy of the Retina~     Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe~     visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa~     (RP). The study is sponsored by the University of Oxford and funded by the National~     Institute for Health Research (UK).~   "
25712|NCT02720627|"~     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis~     suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied~     every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with~     acne vulgaris. Adrenal suppression effects and systemic safety are an important safety~     concern. The current study is designed to investigate these potential concerns under maximal~     use conditions.~   "
25713|NCT02720614|"~     The purpose of this study is to evaluate the safety of accelerated hypofractionated~     three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy~     for patients with unresectable stage III non-small cell lung cancer.~   "
25714|NCT02720601|"~     Biliary tract cancers that progress after first line treatment can be difficult to treat.~     There is a great need for an effective, tolerable, easy to administer second-line regimen.~     Previous early phase studies demonstrated that the combination of two chemotherapy drugs,~     irinotecan and capecitabine had activity in this setting. The goal of this study is to~     determine whether this drug combination, as a second-line treatment, can improve progression~     free survival in patients with biliary tract cancers.~   "
25715|NCT02720588|"~     Specific Aims: This study aims to examine the hypothesis that individuals with Autism~     spectrum disorder (ASD) and their unaffected siblings shared alterations in gray and white~     matter volume and their associated intrinsic functional connectivity, to build upon limited~     literature about neuroimaging endophenotypes of ASD. The investigators also aim to test~     whether these shared differences are associated with behavioral autistic traits.~   "
25716|NCT02720575|"~     The objective of this study is to test the bioavailability of vitamin D in bread.~   "
25717|NCT02720562|"~     Resting state functional MRI is widely used for studying brain functional networks. However,~     in-scanner head movement and other non-neuronal noise can disproportionately bias~     connectivity estimates, despite various preprocessing efforts. To address these issues, the~     technique combining data acquisition with multiecho (ME) echo planar imaging and analysis~     with spatial independent component analysis (ICA), called ME-ICA, has been develop to~     distinguish BOLD (neuronal) and non-BOLD (artifactual) components based on linear echo-time~     dependence of signals, and has been demonstrated to successfully remove non-neuronal~     confounds. Nonetheless, such research approach has never been applied in psychiatric~     populations. The study aims to fill in the gap as shown in the following.~   "
25718|NCT02720549|"~     Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is~     a common problem which influence poor outcome in subjects undergoing valvular heart surgery.~     The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart~     surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote~     ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury~     in previous animal studies and stoke patients. Therefore, the investigators are trying to~     evaluate the clinical effect of remote ischemic postconditioning on postoperative renal~     dysfunction in subjects undergoing valvular heart surgery with bypass.~   "
25719|NCT02720536|"~     Extended evaluation of deferasirox film-coated tablet (FCT) formulation~   "
25720|NCT02720523|"~     A Phase 2b/3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Japanese~     Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of~     Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an~     Inadequate Response to csDMARDs.~   "
25767|NCT02719912|"~     This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter~     heart valve (THV) for mitral valve replacement in subjects at high risk for conventional~     mitral valve replacement or repair surgery.~   "
25721|NCT02720510|"~     This is a multicenter, open-label, randomized phase II study which will enroll 112 newly~     diagnosed symptomatic multiple myeloma patients in a 1:1 fashion. Patients will be enrolled~     at approximately 20 centers in the United States.~      Patients will undergo stem cell mobilization with plerixafor plus Granulocyte Colony~     Stimulating Factor (G-CSF), according to investigator discretion, after 4 cycles of~     induction therapy. Study treatment interruption for stem cell collection may not exceed 30~     days. All patients will receive one additional cycle of study treatment after stem cell~     collection and then proceed to autologous transplant using melphalan 200mg/m2(140mg/m2 for~     patients > 70 years), as conditioning.~      After Autologus Stem Cell Transplant( ASCT), patients still on study will initiate~     maintenance therapy within the 60-120 day period following ASCT, provided they have adequate~     blood count and clinical recovery. Patients in the RVD arm will initiate maintenance therapy~     with lenalidomide alone, and patients in RVD-panobinostat arm will receive lenalidomide +~     panobinostat maintenance. Lenalidomide will be dosed orally at 10mg/day continuously in both~     arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat will be dosed at~     10mg three times a week, every other week. Total planned duration of maintenance therapy~     will be 3 years.~      Patients will remain on study treatment until they complete the maintenance phase, or until~     they experience disease progression, unacceptable toxicity, or at the discretion of the~     Investigator.~   "
25722|NCT02720497|"~     Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and~     Afghanistan with PTSD symptoms, a critical need exists for treatments that are both~     effective and efficient, enabling the greatest number possible to be treated to remission.~     As a highly efficacious treatment and the one with the most scientific support, Prolonged~     Exposure (PE) is recommended by the Institute of Medicine and being rolled out by the~     Departments of Defense and Veterans Affairs to help heal our war fighters' psychological~     wounds. A major barrier to that roll-out, however, is that PE is typically delivered in~     90-minute sessions. This is difficult for military mental health providers, who because of~     large patient loads and pressure to see as many patients per day as possible, limit therapy~     sessions to 60 minutes. The primary aim of this randomized clinical trial is to determine~     whether PE sessions can be reduced to 60 minutes without compromising the treatment's high~     success rate. Preliminary evidence suggests that patients may greatly benefit from PE even~     when the time spent recalling and recounting the trauma memories during sessions (a key~     procedure called imaginal exposure) is shortened to fit into a 60-minute session. To test~     this hypothesis, the trial will enroll 160 San Antonio-area active duty service members who~     will be randomly assigned to receive PE treatment with 60- or 90-minute sessions. In an~     additional effort to learn more about how PE helps patients recover - and thereby gain~     insights to further enhance treatment benefit - the study investigators will examine what~     causes reductions in PTSD symptoms during PE by examining self-reported and physiological~     markers (e.g., heart rate reactivity) between the two treatment groups.~      Research Applicability and Impact: If PE can be shown to maintain high success rates with~     shorter sessions, more military clinicians could offer this powerful therapy, as it would~     fit within time constraints of their heavy workload. This would potentially help thousands~     of our nation's warriors recover from the devastating psychological effects of PTSD and~     maintain their military careers, heal hurting relationships, and reengage in meaningful life~     activities. This study would further benefit the military and the general public by~     enhancing the readiness of our Armed Forces and reducing the public cost of service members'~     lost work time or veterans' disability benefits. Overloaded VA providers and even civilian~     therapists, who often limit sessions to 60 minutes due to insurance reimbursement~     requirements, may also be more likely to utilize the shorter treatment format, increasing~     access to evidence-base care for veterans and civilians. In addition, insights from the~     study's examination of biomarkers and underlying mechanisms of PE could be used to enhance~     care for service members, veterans, and the general public. Study risks are minimal, as a~     small proportion of patients may see temporary symptom increases as they deal with traumatic~     memories, but this is part of the recovery process. Patients receiving the shorter treatment~     sessions potentially may realize a lower level of treatment benefits, but preliminary~     evidence suggests there is good reason to believe their treatment will be equally as~     successful as those receiving traditional PE.~   "
25723|NCT02720484|"~     The primary objective will be to assess overall response rate of nivolumab in patients with~     metastatic or locally advanced adrenocortical carcinoma. Nivolumab was recently approved by~     U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma, non-small~     cell lung cancer and renal cell carcinoma. It is considered investigational for the~     treatment of advanced or refractory adrenocortical carcinoma. Investigational means that~     the drug is not approved by the USFDA or not approved for the indication under~     investigation. Nivolumab could shrink adrenocortical carcinoma but it could also cause side~     effects. Researchers hope to learn if the study drug will shrink the cancer and hopefully to~     relieve symptoms that are related to the cancer.~   "
25724|NCT02720471|"~     Clinical study, comparative, prospective, interventional, randomized, single-center,~     single-blind The fast resumption of the walking after surgery of total prosthesis of hip~     (PTH) requires an effective analgesia from the immediate post-operative period. In France,~     whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional~     anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of~     the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United~     States, the techniques of peroperative infiltration of local anesthetics (IAL) by the~     surgeon supplanted the techniques of traditional ALR. However, no French study compares the~     IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL~     suggests us that it is more effective in terms of post-operative analgesia with Analog~     Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the~     resumption of the upright posture in bipedal support as well as the resumption of the~     walking would be earlier.~      The main objective is to show that the post-operative analgesia by local peroperative~     infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block~     associated with a side cutaneous block of the thigh) after the surgery of total prosthesis~     of hip, with decrease of the consumption of morphine within first 72 post-operative hours.~      The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest~     and with the mobilization during various times (in post-surgery care room, then at H4, H8,~     H12, H24, H48, H72), the period between the end of intervention (out of the operating room)~     and the first support by the upright posture in bipedal support), the period between the end~     of intervention and the resumption of the walk, the satisfaction of the patients at the exit~     of the hospital, the duration of hospitalization after the surgical operation and the~     possible unwanted events (systematic toxicity of the local anesthetics, the infection of~     prosthesis, disease thromboembolic venous) during the hospitalization.~   "
25725|NCT02720458|"~     Persistent insomnia has a high prevalence in French general population affecting between~     15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners~     (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line~     treatment. French Health authorities recommend restricting the consumption of both hypnotics~     to no more than 4 weeks, considering their potential adverse effects (memory impairment,~     altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence.~     However, it appears that a majority of patients become chronic users. Therefore,~     discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge~     due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound~     insomnia).~      Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT)~     principles improve sleep and daily life quality leading to hypnotic taper and maintain of~     hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4~     components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene~     education. This therapy is dependent on a therapeutic alliance between practitioner and~     patient. Unfortunately, there are an insufficient number of trained CBT experts especially~     in France.~      The implementation of an internet-delivered self-help program based on time-in-bed~     restriction and stimulus control may be an issue within the context of general practice.~      Online programs based on CBT principles have been proved to be effective in improving the~     sleep and daytime functioning in this population, but the studies were realized in small~     patients groups.~      Investigators hypothesis is that a simple and internet-delivered short-term program based on~     sleep restriction therapy and stimulus control (following to a GP consultation) may~     facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia~     disorder still reporting sleep complaints in comparison with a tapering alone (no access to~     the self-help program).~   "
25726|NCT02720445|"~     The purpose of the study is to see if daily transdermal nicotine is able to produce a~     significant cognitive, clinical and functional improvement in participants with MCI.~     Neuronal nicotinic receptors have long been known to play a critical role in memory function~     in preclinical studies, with nicotine improving attention, learning, and memory function.~      The study will enroll 300 participants for a 2 year period. Participants will be randomized~     (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to~     21mg/day, or placebo skin patch.~   "
25727|NCT02720432|"~     This current study proposes to analyze the feasibility and effects of the two most used~     therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in~     very young infants (less than one year) with perinatal stroke and with a high risk to~     develop hemiplegic CP.~   "
25728|NCT02720419|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Synergy~     stent compared to other drug eluting stents.~   "
25729|NCT02720406|"~     The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two~     different techniques in pediatric patients undergoing tonsillectomy operations~   "
25730|NCT02720393|"~     Participants will be randomly assigned to either regular or no-carrageenan prepared diets to~     determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin~     A1c is the primary outcome measure.~   "
25731|NCT02720380|"~     This study has the aim to assess the effectiveness of the Buteyko method as an adjunct~     therapy in the treatment of children with asthma.~   "
25732|NCT02720367|"~     The purpose of this study is to determine if GemRIS, an investigational drug-delivery system~     is safe and tolerable in patients with recurrent low or intermediate risk~     non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of~     bladder tumors (TURBT)~   "
25735|NCT02720328|"~     The purpose of this study is to investigate the preventability of serious adverse drug~     reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators~     also aim at identifying the underlying causes of these preventable ADRs. The endpoint~     measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs).~     For this purpose, a protocol for a prospective observational study was developed. The study~     was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques~     Universitaires Saint-Luc. Patients admitted to the emergency department of these two~     teaching hospitals with a thrombotic or a bleeding event while under DOAC or VKA are~     included. After a comprehensive medication history, the appropriateness of prescribing is~     evaluated, using an adapted version of the Medication Appropriateness Index. Causality,~     severity and preventability of adverse events are assessed by two pharmacists and two~     hematologists using predefined scales. Second, for cases of serious and preventable ADRs,~     semi-structured interviews are performed with general practitioners to understand the~     underlying causes of medication errors. Based on the results, risk-minimization strategies~     that specifically target the problems encountered in clinical practice will be proposed.~   "
25736|NCT02720315|"~     Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common~     reason patients seek emergency care. Pain control is an essential component of treatment.~     Within the orthopedic literature, there is robust body of research supporting the use of~     cryotherapy for post-operative patients and injured athletes. However, within the emergency~     department (ED), studies have been focused on pharmacologic analgesia. The absence of~     evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to~     inconsistent practice patterns that may impede symptom control or increase narcotic usage.~      The specific aim of the ICED investigation is to evaluate the effectiveness of intensive~     cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary~     outcomes include length-of-stay (LOS), patient satisfaction, and narcotic usage.~   "
25737|NCT02720302|"~     The present study is a public health project with the aim to treat overweight in children~     9-11 years of age. After the first consultation the children are randomized to either~     continue the treatment at The Child Obesity Clinic, Child Department or to have the~     following 2-3 consultations on distance with Lync. Last visit for all children is on the~     Child Obesity Clinic after approximately 12 months. Follow up after at least 1 years will be~     performed.~   "
25738|NCT02720289|"~     This study compares a video-based social learning method to the traditional didactic method~     as a new way to teach caregivers about child passenger safety, including how to install a~     car seat. Half of the caregivers will attend the video-based social learning class, while~     the other half will attend the traditional didactic class. The investigators hypothesize~     that the video-based social learning method will lead to an equal or greater increase in~     caregiver child passenger safety proficiency when compared to the traditional didactic~     method.~   "
25739|NCT02720276|"~     The purpose of this exploratory study is to investigate how a predetermined outdoor walking~     program (12 weeks) is best delivered to individuals with stroke over 18 years, either by~     smartphone and the Short Message Service (SMS) or video link.~      Furthermore, the aim is to investigate how the study design works in practice and determine~     the effects of the outdoor walking exercise program in combination with a leg exercise on~     physical functioning (walking capacity, gait speed, mobility and grip strength).~   "
25740|NCT02720263|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     oral doses of ASP4345 in patients with schizophrenia. In addition, this study will evaluate~     the pharmacokinetics of multiple ascending oral doses of ASP4345 in patients with~     schizophrenia.~   "
25741|NCT02720250|"~     Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on~     vascular health in overweight and/or hypertensive patients.~      However, there is a lack of studies showing the effect of everyday consumption of omega-3~     fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in~     healthy population.~      This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on~     microvascular reactivity and lipid profile in young healthy subjects.~   "
25742|NCT02720237|"~     The purpose of this study is to compare the effectiveness of two interventions [a Brief~     Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy~     (MET+CBT) Intervention], against each other and with an assessment-only control, in~     improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking~     HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.~   "
25743|NCT02720224|"~     This study is being conducted to further understand the elimination pathways, metabolite~     profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).~   "
25744|NCT02720211|"~     Nearly all migraine sufferers report sensitivity to light during a headache and a~     significant proportion of sufferers report light sensitivity between attacks. Light is also~     a common trigger for migraine headaches. Spectacle lenses that have been treated with tints~     and spectacle lenses that have been treated with thin-films have both been shown to reduce~     light sensitivity and headache in patients with migraine. At this time, it is not clear~     which spectacle lens treatment is superior. The purpose of this trial is to determine if~     there's a significant, therapeutic advantage to either spectacle lens treatment. Both~     treatments could be a novel, non-invasive adjuvant in the treatment of migraine.~   "
25745|NCT02720198|"~     This study's primary objective is to compare the efficacy and tolerability of switching~     patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new~     treatment (quetiapine ER) to your existing treatment with people diagnosed with depression~     (major depression disorder).~      The secondary objective is to examine the response and remission rates following the switch~     from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with~     examining changes in neurocognitive and apathy measures after the switch.~   "
25746|NCT02720185|"~     Primary Objective:~      To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear~     translocation of the epidermal growth factor receptor (EGFR) in operable, nuclear EGFR~     positive, triple negative breast cancers (TNBC).~      Secondary Objectives:~        1. To examine the safety and tolerability of dasatinib in patients with operable TNBC~        2. To explore potential intracellular mechanisms which impact dasatinib effect on cellular~          localization of EGFR in operable TNBC.~   "
25747|NCT02720172|"~     The overall objective of this two-group randomized controlled trial is to gather preliminary~     evidence on the efficacy and safety of early postoperative exercise for improving~     disability, pain, and general physical health in patients after anterior cervical discectomy~     and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program~     (HEP) performed within the first six weeks after surgery will decrease disability and pain~     and improve general health, through increases in physical activity and self-efficacy and~     reductions in fear of movement. The results of our randomized trial will advance research on~     postoperative management for patients with cervical spine surgery and provide evidence in~     line with a value-based healthcare approach for optimizing outcomes.~   "
25748|NCT02720159|"~     The purpose of the clinical study is to characterize the efficacy and safety of a~     Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory~     platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal~     seal, thus allowing a proper biobarrier around the implant.~   "
25749|NCT02720146|"~     Poor corneal epithelialization problem can be found in a lot of ocular surface disorders,~     including limbal insufficiency, dry eye, chemical burn and neurotrophic disorders. Delayed~     corneal epithelialization under any circumstances can lead to corneal infection, corneal~     melting, corneal opacity, pain or blurred vision. It is thus important to develop~     pharmacological methods to promote corneal epithelial wound healing in those patients.~     Previously, various epitheliotrophic growth factors, autologous serum, cord blood serum,~     etc. have been proved to be effective in promoting corneal epithelial wound healing.~     However, those topical agents have the drawbacks including the difficulties during~     preparation, expensive price, non-standardized quality and the risk of contamination during~     preparation. It will be clinically important to find other blood derivatives which are~     effective, convenient for use, stable in quality and being cheap.~      During the recent few years, various platelet related blood derivatives have been proved~     to contain a lot of epitheliotrophic growth factors, and can promote wound healing. Among~     those products, platelet lysate has the benefits of being commercially available. It can~     avoid the complicated producing procedure, and has stable quality. Although platelet lysate~     has been widely used in various medical fields, especially in culturing mesenchymal stem~     cells, its potential in promoting corneal epithelial wound healing has not been proven. The~     purpose of this project is to explore the possibility of using platelet lysate to treat~     patients with poor corneal epithelialization problem, and compare its epitheliotrophic~     ability with other blood derivatives. The cultured human corneal epithelial cell line will~     be used for all experiments, and will be cultured with media containing different blood~     products: (1) control group without blood derivatives, (2) fetal bovine serum, (3) human~     serum, (4) platelet lysate commercial product—UltraGro, (5)platelet lysate commercial~     product---PlatMax. MTS assay will be used to measure proliferation ability. Scratch-induced~     directional wounding assay and Boyden chamber chemotaxis assa will be used to measure~     cell migration. Scanning electron microscopy, transmission electron microscopy,~     transepithelial electric resistance (TEER) and immunohistochemistry with junctional proteins~     will be used to measure cellular differentiation. Through these experiments, the~     investigator aim to understand whether platelet lysate can replace other blood derivatives,~     and be used for treating patients with corneal epithelialization problem.~      Beside, current medications in dry eye are all manufactured, transported and used in the~     form of liquid form. However, it is more disturbing in transporting, commercializing,~     storing and the limitation of expiration date for current medications compared with powder~     form medications. Therefore, improving the convenience of utilizing and storage without at~     the expense of the efficacy of blood-derivatives has become a critical issue. Our study also~     aimed at trying to produce platelet-related derivatives (including platelet lysate) and~     human serum into the form of dry powder and resuspended it with preservative-free artificial~     tears. The investigator would compare the epitheliotrophic ability of the liquid form of~     blood derivatives and the powder form of blood derivatives.~      Since human serum is needed for comparison , the investigator proposed this IRB to collect~     human serum from healthy volunteers。~   "
25750|NCT02720133|"~     Ramadan Fasting has multiple effects on the variation of hematological and biochemical~     parameters.~   "
25751|NCT02720120|"~     This study is in two parts and will evaluate the safety, tolerability and efficacy of~     escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination~     with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation~     study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000~     milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and~     efficacy of doses which have been shown to be tolerated in Part 1.~   "
25752|NCT02720107|"~     The purpose of this single visit extension study is to explore immune status in RRMS~     patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts~     will be compared to short-term changes in immune status (baseline to month 6) after~     treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).~   "
25753|NCT02720094|"~     This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB~     LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender~     women who have sex with men (MSM and TGW).~   "
25754|NCT02720081|"~     The purpose of this trial is to compare the safety, tolerability, and efficacy of adding~     MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving~     montelukast alone. Participants will have a specific genetic marker for clinical efficacy of~     MK-1029.~   "
25755|NCT02720068|"~     This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination~     with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no~     available therapy which may convey clinical benefit. Part A of this study is a dose~     escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in~     combination with pembrolizumab. Part B is a dose confirmation design to estimate the~     recommended Phase 2 dose for MK-4280 in combination with pembrolizumab.~   "
25756|NCT02720055|"~     A randomised controlled trial to compare two different rehabilitation work books used in~     patients with wrist fracture.~   "
25757|NCT02720042|"~     The purpose of this study is to collect additional data on safety and performance of Phasix™~     Mesh in subjects requiring VHWG Grade 3 midline hernia repair.~   "
25758|NCT02720029|"~     Monitoring and quantification of reflux events in high risk critically ill inpatients and~     lower risk general medical/surgical inpatients, with comparison to relevant clinical~     variables.~   "
25759|NCT02720016|"~     Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with~     impairment in functioning across a host of psychosocial domains including occupational and~     academic functioning, marital and family functioning, parenting, and socialization.~     Impairment is not limited to Veterans with PTSD because the entire family is affected,~     particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on~     both members of the dyad. Despite the need for treatment, many Veterans and their families~     do not access PTSD-related services due to a number of barriers to accessing care (e.g.,~     living in rural or remote areas where no specialty services exist, concerns about stigma~     around using mental health services, limited clinic hours to accommodate patient schedules).~     The objective of this study is to assess whether providing Cognitive-Behavioral Conjoint~     Therapy, in which PTSD symptoms and intimate relationship functioning are addressed, to~     Veterans and their romantic partners in their homes via clinical video teleconferencing~     leads to better outcomes compared to office based treatment.~   "
25760|NCT02720003|"~     To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion~     of the superficial femoral and popliteal arteries.~   "
25761|NCT02719990|"~     Open-label extension study to evaluate the safety of long-term twice-monthly administration~     of somavaratan in adults with Growth Hormone Deficiency (GHD).~   "
25762|NCT02719977|"~     CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot~     easily repair damage to their cells. This may help to slow down the growth of cancer or may~     cause cancer cells to die. CX5461 has been shown to shrink tumours in animals and has been~     studied in a few people and seems promising but it is not clear if it can offer better~     results than standard treatment.~   "
25763|NCT02719964|"~     The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual~     attention deficits in U.S. military service members across three programs: Visual Attention~     and Working Memory Programs (UCR Games), Speech Pathologist-Directed Treatment, and General~     Cognitive Rehabilitation Games (Lumosity).~      In addition to the above prospective component, this study also has a retrospective~     component in which archival data collected from routine clinical care will be examined for~     analysis. The investigators hope to gain a better understanding of the unique and cumulative~     influence different cognitive rehabilitation programs have on improving attention complaints~     in mTBI.~   "
25764|NCT02719951|"~     Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in~     autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers~   "
25765|NCT02719938|"~     The objective of this study is to generate preliminary data for a large multi-site~     randomized clinical trial of a model of palliative care consultation for patients with~     advanced dementia, and for their family caregivers.~   "
25768|NCT02719899|"~     Background:~      Researchers want to better understand the body s immune response to calorie restriction. To~     do this, they are asking healthy volunteers to fast for 24 hours. Researchers will test~     immune response before and after fasting.~      Objectives:~      To explore the benefits of calorie restriction on immune health.~      Eligibility:~      Healthy volunteers ages 21 to 37 with a body mass index between 22 and 29.~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will visit NIH after an overnight fast. Their baseline immune response will be~     taken. They will give blood and urine samples. Then they will be given breakfast. This visit~     will take about 2 hours.~      Participants will fast (not eat or drink anything except water) for the next 24 hours. They~     will return to NIH the next morning. Their immune response will be taken. They will give~     blood and urine samples. Then they will be given breakfast. Their immune response will be~     taken 3 hours later. They will give a blood sample. This visit will take about 4 hours.~   "
25769|NCT02719886|"~     The purpose of this randomized controlled trial is to compare the frequency of the diagnosis~     of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week~     intervals.~   "
25770|NCT02719873|"~     A study will carried out over a period of one year , all obese pregnant women as diagnosed~     with BMI at the time of 1st ANC visit and before labor ,observation of events during both~     intra-partum &postpartum periods it will be recorded.outcome will compared with normal other~     pregnant women~   "
25771|NCT02719860|"~     The overall objective of this study is to determine the effect of high tea consumption on~     biological markers of oxidative stress that mediate lung cancer risk.~   "
25772|NCT02719847|"~     The goal of this clinical research study is to compare the results of EBUS-TBNA with the~     results of PET/CT scans to learn about the accuracy of these ways to find evidence of early~     stage lung cancer.~   "
25773|NCT02719834|"~     Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with~     dementia and are a major source of patient and caregiver distress, nursing home placement,~     anti-psychotic medication use, restraints, and increased health care costs. The purpose of~     the research study is to investigate whether reducing pain reduces behavioral expressions of~     Alzheimer's disease (agitation and aggression).~   "
25774|NCT02719821|"~     The goal of this project is to refine and evaluate the feasibility of a brief, behavioral~     intervention to improve the recovery following hematopoietic stem cell transplantation~     (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to~     improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue,~     and depression after HSCT. If the intervention is feasible and acceptable to patients, a~     future study will test the effects in a larger trial, with the long-term goal of improving~     the care and quality of life of cancer survivors recovering from HSCT.~   "
25775|NCT02719808|"~     500 pregnant patients with HBeAg-positive and HBV-DNA> 106copies /ml who will do their~     pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be~     enrolled into the study. There will be five groups to be observed. Four groups are taking~     tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any~     anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV~     intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue~     will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of~     HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir~     blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.~   "
25776|NCT02719795|"~     The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce~     chronic pain at 3 months after modified radical mastectomy（MRM）surgery.~   "
25777|NCT02719782|"~     Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients,~     while treatment measures are limited. This study plans to recruit 10 patients with Hepatitis~     B virus (HBV) related HCC who underwent liver transplantation and are confirmed to have~     recurrent HCC. The objective of the study is to assess the safety, tolerability and~     effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target~     population.~   "
25778|NCT02719769|"~     The Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood~     Culture Identification & Antimicrobial Susceptibility Testing is designed to validate the~     clinical performance of the Accelerate ID/AST System for positive blood culture~     identification and susceptibility testing in a clinical setting. The data from this study~     will be used to support the 510(k) submission for FDA clearance and global registrations of~     the device intended for in vitro diagnostic use.~   "
25779|NCT02719756|"~     This study will test the hypothesis that early use of combination therapy with dapagliflozin~     and metformin will provide good glycemic control with low glycemic variability and without~     hypoglycemic episodes, and will be better tolerated than up-titration of metformin~     monotherapy. The study will also correlate these benefits with glycated hemoglobin.~   "
25780|NCT02719743|"~     The purpose of this study is to assess the safety and immunogenicity of different~     formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35~     months of age.~   "
25781|NCT02719730|"~     This study will assess the impact of a randomized intervention aimed at increasing~     consumption of whole grain foods among children from low-income households that participate~     in the Special Nutrition Assistance Program (SNAP, or food stamps). A total of 60 obese~     children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active~     Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital~     Oakland. Participants and their caregivers will all receive education about whole grain~     foods, and will be randomized to either an intervention or control group. The intervention~     group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP~     benefit for specific whole grain foods purchased during the three month study period. The~     control group will not have the financial incentive for purchasing whole grain foods during~     the 12 week study period. The investigators will assess the feasibility of the intervention,~     the impact of the intervention on household grocery purchases, and the impact on the child's~     anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of~     metabolic risk.~   "
25783|NCT02719704|"~     The main purpose of this study is to analyse the effect of a multicomponent intervention,~     applied during one scholar semester, on body composition, strength, flexibility,~     cardiorespiratory fitness, lipid and metabolic profile, and body image of students from~     sixth to ninth grade. This is a non-randomized controlled design. Approximately 568~     schoolchildren of grades sixth through ninth were recruited from 2 public secondary schools~     in Florianópolis, Brazil. The main component of the intervention entitled MEXA-SE (move~     yourself) consisted of the implementation of three physical education classes per week with~     aerobic exercises, strength and flexibility activities. In addition, play activities in~     school recess, and educational activities on physical activity, sedentary behaviour, eating~     habits and body image were performed. Data collection was performed before and immediately~     after 14 weeks of intervention. The primary outcomes included the body composition,~     strength, flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body~     image. Other variables included were: physical activity level, sedentary behaviour, and~     blood pressure level. Other components of the lifestyle (e.g., eating habits), psychological~     (e.g., self-rated health) also were evaluated in the participants. Descriptive analysis,~     two-way ANOVA for mixed models and ANCOVA will be applied for within and between comparison~     groups, if the premises of this test are met. The level of significance for the study was 5%~     for two-tailed tests.~   "
25784|NCT02719691|"~     This is a phase Ib study designed to evaluate the safety and toxicity of the combination of~     Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in~     patients with previously treated metastatic TNBC.~   "
25785|NCT02719678|"~     The effect of systematic health examinations and screening of the general population is~     under debate. Recently, a large Danish randomized study found that systematic screening of~     risk factors and lifestyle advice in the general population did not have a preventive effect~     on coronary heart disease, stroke or all-cause mortality. However, there are still very few~     completed randomized studies, and the effect on other diseases remains unclear. The purpose~     is to investigate whether repeated health examinations with screening of various risk~     factors in an unselected population prevent long-term incidence of ischemic heart disease,~     stroke, total and cause-specific mortality, diabetes, dementia, chronic obstructive~     pulmonary disease and various forms of cancer. A preliminary protocol was submitted and~     approved by the Danish Data Protection Agency before the registry-based data on primary and~     secondary outcomes were received by the investigator.~   "
25786|NCT02719665|"~     The purpose of this study is to understand the effects of fish oil supplement (containing~     parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify~     which dose of the fish oil supplement is the most effective. The name of the fish oil~     supplement is SPM Emulsion.~   "
25787|NCT02719652|"~     Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The~     occurrence of stroke caused by symptomatic ICAD is significantly different compared with~     asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for~     the difference. Based on the previous high-resolution magnetic resonance vessel wall imaging~     (HR-MRI) results, the investigators hypothesis that the feature of intracranial plaque~     enhancement is an important imaging biomarker of plaque instability, which is closely~     related to stroke. The investigators will establish the ICAD cohort and use HR-MRI to~     investigate the composition, morphology and the enhancement pattern of symptomatic ICAD~     plaques. These findings will correlate with biochemical markers, and stroke recurrence, in~     order to explore:~        1. plaque characteristics and the enhancement features between symptomatic ICAD and~          asymptomatic ICAD~        2. the relationship between plaque enhancement and the composition of plaques;~        3. relationship among enhancement features of symptomatic ICAD plaques, biomarkers with~          different clinical significance,~        4. evolution of enhancement features of symptomatic ICAD plaques under intensive medical~          therapy.~      The investigators aim to explore the correlation between vulnerable plaque stratification~     and clinical outcomes, to explore the value of vascular responses in the pathogenicity of~     ICAD vulnerable plaques, as well as to provide objective basis for the establishment of the~     evaluation criteria of intracranial atherosclerotic vulnerable plaques.~   "
25788|NCT02719639|"~     Real-world data on the effects of a fixed-dose combination Long-acting beta agonists +~     long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol~     administered in a single device, in COPD patients who need treatment with two long-acting~     bronchodilators, is not available. This is a self-controlled study design enrolling~     consented COPD patients who will be treated with Spiolto Respimat according to the approved~     Summary of Product Characteristics (SmPC).~   "
25789|NCT02719626|"~     Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated~     agencies in five states to conduct a study designed to improve food safety nutrition and~     emergency preparedness among homebound elderly recipients of home delivered meals (HDM).~     This population is at increased risk for food borne diseases, as a result of unique~     physiological and behavioral factors, and is particularly vulnerable to any disruptions in~     the food system because of their lack of mobility.~      A multi-method research approach will be used with a target sample of 1,000 MOWA homebound~     elderly clients. Methods include the use of a novel UPC scanning technology that quickly and~     comprehensively catalogues all of the food in the clients' homes, a home food safety audit,~     and a face-to-face interview.~      The goal of the study is to provide an improved understanding of the unique food safety~     threats to this at-risk population, suggest easy, cost-effective ways of reducing known food~     safety risk factors, and provide clear guidelines about the amount and types of food most~     needed by this population in emergency situations. Dissemination of research findings and~     recommendations will be done through a partnership with EDEN and MOWA, both of which have~     national constituencies poised to act on the recommendations.~   "
25790|NCT02719613|"~     The purpose of this study is to continue to provide elotuzumab and/or other study drugs to~     subjects who have participated on a prior protocol investigating elotuzumab who are not able~     to receive commercial drug supply.~   "
25816|NCT02719236|"~     The purpose of this study is to compare the direct anterior approach and the direct lateral~     approach in primary total hip arthroplasty, regarding the postoperative function and pain,~     complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle~     damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate~     aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical~     outcomes.~   "
25791|NCT02719600|"~     Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics.~     Despite cognitive and motor difficulties, there is a possibility of intervention based on~     the knowledge of motor learning. However, it is important to study the motor learning~     process in individuals with DS during a virtual reality task to justify the use of virtual~     reality to organize intervention programs. The aim of this study was to analyze the motor~     learning process in individuals with DS during a virtual reality task. Methods: A total of~     40 individuals participated in this study, 20 of which were with DS (24 males and 8 females,~     ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and~     gender to the individuals with DS. To examine this issue, we used software that uses 3D~     images and reproduced a coincidence timing task.~   "
25792|NCT02719587|"~     The investigators primary objective in this clinical intervention study, therefore, was to~     explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary~     markers (in patients with chronic periodontitis.~   "
25793|NCT02719574|"~     This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to~     evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine~     (combination agent) administered via one or more intermittent dosing schedules.~     Approximately 48 patients will be enrolled in the dose-escalation portion of this study in~     one or more schedules followed by approximately 14 patients in expansion cohorts~   "
25794|NCT02719561|"~     Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer~     patients. Despite this, there has been virtually no research evaluating treatment for~     cancer-related fatigue in this young patient group. The investigators are undertaking a~     small qualitative study to co-design a fatigue intervention, that will then be evaluated in~     future research to assess its effectiveness.~   "
25795|NCT02719548|"~     A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In~     phase I the comfort will be assessed, the occurence and types of adverse events will be~     recorded and the assessment how and if the different breast shield designs interact with the~     lacting breast during pumping. Phase II takes place at home; assessment of adverse events~     will be recorded and the assessment how the subjects perceives the comfort of the soft edge~     breast shield during mid term use at home.~   "
25796|NCT02719535|"~     The aim of the proposed study is to investigate the predictive value of corneal~     biomechanical properties in corneal reshaping therapy and the role of these parameters in~     determining the amount of myopia reduction.~   "
25797|NCT02719522|"~     This is a prospective, single-arm, multi-center post-market observational study assessing~     the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in~     subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market~     setting.~   "
25798|NCT02719509|"~     This is a prospective observational study evaluating the diagnostic utility of cardiac~     ultrasound in patients who present to the emergency department with undifferentiated chest~     pain or shortness of breath. Emergency department providers will be interviewed before and~     after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any~     changes in management. Other outcomes include determination of incidence of unexpected~     findings.~   "
25799|NCT02719496|"~     The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a~     28-day period, for the treatment of constipation in parkinsonian patients suffering from~     gastrointestinal disorders.~   "
25800|NCT02719483|"~     The purpose of this study is to determine whether radial extracorporeal shock wave therapy~     in combination with traditional physical therapy is safe and effective for the management of~     spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three~     years of age.~   "
25801|NCT02719470|"~     In order to explore the question how an intensive, goal-based and aerobic rehabilitation~     treatment, addressed to act on motor and mental aspects, affects motor and functional~     symptoms in PD patients with normal cognition and with different level of cognitive~     impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive~     training and repetition, can affect positively the rehabilitation outcome regardless of~     baseline cognitive profile.~   "
25802|NCT02719457|"~     the aim of this study to assess the relationship and compare physiological response between~     spot marching exercise test and 6 minute walk test in patient with chronic obstructive~     pulmonary disease~   "
25803|NCT02719431|"~     The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the~     pharmacokinetics of warfarin in healthy adults volunteers.~   "
25804|NCT02719418|"~     The purpose of this study is to assess if accumulation of anti-Xa activity occurs after~     repeated daily administration of prophylactic doses of tinzaparin in patients with severe~     chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.~      It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD~     patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not~     bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level~     between day 2 or 3 and day 5.~   "
25805|NCT02719405|"~     Primary Endpoint~      -The percentage of subjects who develop tolerance to cow's milk protein by 12 months post~     randomization to study formula.~      Secondary Endpoints~        -  Tolerance~             -  The transcriptional profile of milk-specific T cells by clinical outcome.~             -  Growth and Weight Velocity~             -  Stool Consistency and Frequency~             -  The estimated frequency of milk-specific T cells by clinical outcome.~             -  The TCR diversity of milk-specific T cells by clinical outcome.~             -  The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.~        -  Safety~             -  The rate of reported adverse events by treatment group.~   "
25806|NCT02719392|"~     The purpose of the Pilot Study Investigating the Efficacy of Minocycline and~     n-acetylcysteine for Bipolar Depression is to test the effectiveness of minocycline,~     n-acetylcysteine, and combined minocycline and n-acetylcysteine pharmacotherapy in order to~     fill the gap in treatments for bipolar depression. The treatment of bipolar depression~     remains the greatest unmet need in the management of this lifelong and chronic psychiatric~     disorder.~   "
25845|NCT02718859|"~     The purpose of this study is to evaluate the safety and efficacy of the combined therapy~     using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic~     cancer.~   "
25807|NCT02719379|"~     Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control~     (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung~     condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine~     (PPSV23). The purpose of this study is to increase awareness of vaccination to late~     adolescents with asthma and smokers (social aspect of study), and to recommend vaccination~     (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled~     in research to determine whether late adolescents with and without asthma (smokers) have~     distinctive pneumococcal vaccine response patterns and whether such patterns are associated~     with subsequent variance in asthma outcomes.~   "
25808|NCT02719340|"~     Although long-segment posterior spinal fixation might provide more rigid fixation, the~     procedure increases perioperative morbidities in the elderly. The present study reviews the~     results of short-segment decompression and reconstruction in thoracolumbar fragile~     fractures.~   "
25809|NCT02719327|"~     The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by~     2050. Compared to the general population, Veterans have a greater risk of AD, likely in part~     due to their increased incidence of traumatic brain injury, post-traumatic stress disorder,~     depression, and other vascular-related health issues. Based on available data, 423,000 new~     cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies~     to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to~     evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid~     (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of~     AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with~     increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD~     would be reduced by 50% in this population and could have a profound effect on Veteran~     quality of life and healthcare costs.~   "
25810|NCT02719314|"~     Glucocorticoids remain to be among the most important and most frequently used~     anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic~     (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects,~     especially if higher dosages have to be given over longer periods of time. The available~     data describing frequency and severity of these adverse effects are fragmentary. This~     statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context~     of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis). The state of~     knowledge and scientific data, being sparse, is partly conflicting and often derived from~     over-aged projects or studies. Therefore, there are urgent needs to work on various current~     questions systematically and at the highest scientific level possible. In order to address~     these needs, we aim at collecting and analyzing disease- and bone-related data from patients~     with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids,~     and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where~     necessary therapy and follow-up of GIOP, according to current guidelines. Clinical,~     laboratory and instrumental examination results from more than 1000 patients in the first~     three years of the project are planned to be documented in a prospective database.~   "
25811|NCT02719301|"~     Study will compare measurements made with Necklace device for stroke volume/cardiac output~     with values from a FDA-approved reference device. The gold standard that will be used is~     Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the~     Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the~     reference device and the Necklace.~   "
25812|NCT02719288|"~     Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons~     due to tendon adhesion complications. Functional recovery is compromised by limiting~     post-operative range of motion, mobility, and can lead to considerable amount of~     post-operative pain for the patient.~      Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and~     anti-scarring agent and promoting wound healing towards regeneration.~      Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of~     CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators~     hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the~     overall functional recovery of the patient.~   "
25813|NCT02719275|"~     Suicide is the 2nd leading cause of death for teenage youth in Canada, and every year tens~     of thousands of young people engage in suicidal behaviors. Many young people manifest~     red-flag behaviors in the digital realm before these incidents occur. The faceless nature of~     online communication often emboldens youth to reveal details about their mental state:~     leaving tell-tale signs or bread crumbs of their suicidal intentions or behaviors.~      This research will examine the content of adolescents social media entries to find red flags~     and detect patterns in social media interactions of adolescents that could be predictive of~     subsequent suicide risk. The study participants will be patients admitted to Child and~     Adolescent Psychiatry Emergency unit at BCCH, subdivided into two groups: those admitted due~     to suicidal behaviors, and those admitted for non-suicidal behaviors. The text of social~     media activity for the month prior to emergency admission of the two groups will be~     collected, anonymized, and analyzed using text-analytic algorithms. The objective of the~     study is to find patterns and indicators of social media entries, prior to admission, that~     would have been predictive of suicidality.~      The implications of successful outcome of this project for mental health care of children~     and adolescents reaches well beyond the scope of this study. An objective method to predict~     risk of suicidal behaviors in youth has application in almost all pediatric clinical~     settings. The outcomes of this project will also serve as the foundation for further~     utilization of social sensing technology to identify, predict, and prevent many other mental~     health crises in children and adolescents.~   "
25814|NCT02719262|"~     The investigators recent study has found that ambient melamine exposure can cause the~     increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in~     this year, the investigators will examine whether the intervention by installing ventilation~     in the workplace and providing personal protective equipment and education can decrease~     ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury~     such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).~   "
25815|NCT02719249|"~     Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or~     transplant in west of France.~   "
25817|NCT02719223|"~     Rationale and objectives~        1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with~          less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis~          (HD). The investigator will follow the hemodynamic parameters during the dialysis~          sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.~        2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate~          the hemodynamic parameters and compare the two renal replacement treatment modalities,~          and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.~   "
25818|NCT02719210|"~     All the children with acute liver failure who are candidates for transplant but have~     constraints for transplant will be randomized either to receive standard medical therapy or~     high volume plasma exchange along with standard medical therapy with the aim to assess the~     effect of high volume plasma exchange on transplant free survival.~   "
25819|NCT02719197|"~     The primary purpose of this first-in-man study is to investigate whether a new drug for~     neurological disorders is safe and well-tolerated when administered orally to healthy male~     adults~   "
25820|NCT02719184|"~     The study will include 125 healthy subjects (ex-smoker without any airflow limitation), 125~     COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125~     COPD GOLD III and up to 40 (with a minimum of 20) patients with COPD and A1AT~     (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be~     investigated addressing different aspects of disease pathways postulated to be relevant for~     COPD progression.~   "
25821|NCT02719171|"~     The overall purpose of this trial is to assess clinical efficacy and safety of different~     subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic~     arthritis in order to select doses for further clinical trials.~   "
25822|NCT02719158|"~     This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled,~     blinded study in which eligible subjects with either unilateral or bilateral acute otitis~     media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201,~     12 mg OTO-201, or sham into the affected ear(s).~   "
25823|NCT02719145|"~     This cross sectional study will be carried out on 30 subjects who will be recruited from the~     outpatient clinic of Chest Department, Tanta University Hospital.~      They will be classified into 3 groups:~      Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10~     asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21,~     miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects~   "
25824|NCT02719132|"~     This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV~     study.~      The primary objective is to compare the effect of dapagliflozin 10 mg once daily in~     combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose~     titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life~     and treatment satisfaction in patients with type 2 diabetes.~   "
25825|NCT02719119|"~     Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are~     obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy~     of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was~     conducted in order to compare the long-term results of EVL when performed at two different~     results from monthly and bi-weekly treatments.~   "
25826|NCT02719106|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster~     stent compared to other drug eluting stents.~   "
25827|NCT02719093|"~     Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G~     variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it~     has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm~     concentration and the total sperm count. A recent Cochrane review showed a beneficial effect~     on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor~     subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very~     important, in particular for what regards nonidiopathic patients. In many andrological~     units, patients underwent adiuvant therapy with purified or recombinant FSH after~     varicocelectomy. FSH treatment in patients after varicocelectomy could improve~     spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in~     our hospital only patients with a morphologic aspect of hypospermatogenesis underwent~     therapy with purified or recombinant FSH, because this therapy is not much useful in patient~     with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to~     correlate non responder patients who underwent FSH adiuvant therapy after varicocele~     surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that non~     responder patients can beneficiate from a high-dose therapy with FSH. This is a prospective~     intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and~     varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar~     technique) and needle aspiration testicular cytology (Foresta technique).~   "
25828|NCT02719080|"~     This study was designed to observe the cerebral state obtained via wavelet analysis~     (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various~     states in anesthesiologist and surgeon. And we also explore the association between the~     characteristic of cerebral state and the emotion.~   "
25829|NCT02719067|"~     The significance of this project is the first longitudinal study to investigate the changes~     of neurocognitive functions of children and adolescents with ASD and to identify the~     potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging~     technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition~     to single-echo resting-state fMRI). The success of this project will fill the gap of our~     understanding of longitudinal changes of brain function by neuropsychological and imaging~     approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of~     translational research in ASD.~   "
25846|NCT02718846|"~     A multicenter, randomized, open-label clinical study with a concurrent control group to~     assess the effectiveness and safety of combined therapy with Isobide solution and Meniace~     tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease~   "
25847|NCT02718833|"~     This research study is studying a combination of study drugs as a possible treatment for~     relapsed and refractory Multiple Myeloma. The interventions involved in this study are~     elotuzumab, pomalidomide, bortezomib, dexamethasone.~   "
25830|NCT02719054|"~     Investments in Early childhood Development (ECD) programs produce higher economic return~     through maximizing human potential. In developing countries over 200 million children do not~     reach their developmental potential. Early nutritional support and psycho social stimulation~     are essential for optimum development of children. Mothers are usually the key providers of~     childcare.~      Depression is reported as a leading cause of disease burden for women and maternal mental~     health is identified as one of the major predictors of child development.~      In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of~     Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About~     one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in~     Bangladesh have showed moderate improvements to children's development. This indicates that~     there are still some gaps in the pathway to delivery. So, it is crucially important to~     address maternal mental health along with any Early Childhood Development intervention at~     community level to get bigger impact.~      In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due~     to the stigma attached to it. Depressed mothers who do not receive treatment often fail to~     provide sufficient stimulation and care for their children and in turn compromise benefits~     of early stimulation programs. Rahman and colleagues (2008) tested an innovative model of~     community-based depression management using Cognitive Behavioral Therapy in Pakistan and~     reported improvement in maternal depression 6 months postpartum.~      The study plans to combine the above treatment of depression with an evidenced-based Early~     Childhood Development program to achieve maximum benefits on reducing maternal depressive~     symptoms as well as improving children's overall development.~   "
25831|NCT02719041|"~     The main goal of this study is to employ a novel proteomic approach to identify predictive~     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)~     targeted therapy in epithelial ovarian cancer. It is expected that these predictive~     biomarkers will be applied to increase the response rate in selected groups of patients.~   "
25832|NCT02719028|"~     Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and~     fatty liver.~   "
25833|NCT02719015|"~     The goal of this clinical research study is to find the highest tolerated dose of rAd.CD40L~     (also called ISF35) when given with pembrolizumab to patients with melanoma. Researchers~     also want to learn if the highest tolerated dose of ISF35 and pembrolizumab can help to~     control the disease.~      The safety of this drug combination will be also be studied.~   "
25834|NCT02719002|"~     Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the~     sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already~     irreversible and the clinical picture may even continue to deteriorate for several years~     after the end of synthetic antimalarial use. In opposition, the early termination of~     hydroxychloroquine in patients showing recent alterations on the multifocal~     electroretinogram (nfERG) allowed he reversibility of toxic damage over a six month period.~     It is therefore critical to detect early retinal anatomic changes during retinotoxicity~     screening before the occurrence of irreversible anatomical and functional consequences.~      The usual patient monitoring consists of an annual eye examination, detecting subjective~     functional abnormalities (visual acuity, color vision, central visual field testing) or~     macular lesions (eye fundus). These abnormalities show a constituted infringement and do not~     contribute to the early diagnosis of synthetic antimalarial maculopathy.~      The mfERG is an objective examination, able to detect retinal damage whilst still~     reversible. It is recommended during the annual monitoring and is, today, the gold standard~     for the screening and diagnosis of synthetic antimalarial maculopathy. However, its~     realization is time consuming, requires a good patient cooperation and is difficult to~     access due to the few ophthalmology centers offering it. In practice, it is rarely done as a~     systematic annual screening for patients on long-term synthetic antimalarial treatment. It~     is often limited to second-line studies (for patients already showing functional or~     anatomical abnormalities) whereas its interest lies in the detection of early lesions.~      The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination,~     commonly used since nearly 10 years. A special image analysis provides a panoramic viewing~     of the state of the photoreceptor layer, and a non-invasive detection of any anatomical~     changes, even subtle, within this layer.~      The concordance between the en face OCT and the mfERG in the screening of synthetic~     antimalarial maculopathy is considered in this study.~   "
25835|NCT02718989|"~     The purpose of this study is to determinate whether the application of electric currents~     produce changes in the excitability of alpha moto neurone. Moreover evidence whether the~     effect of the electric currents can change the tone of the muscle under stimulation in~     healthy volunteers~   "
25836|NCT02718976|"~     The main objective is to complete a double-blinded randomized controlled crossover trial of~     lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance~     imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy~     volunteers.~      The investigators will assess block procedure-related parameters, anatomical spread of local~     anesthetic, and motor and sensory effects.~   "
25837|NCT02718963|"~     The purpose of this study is to determine the synchronized electrical stimulation device~     effective in the treatment of dysphagia.~   "
25838|NCT02718950|"~     The purpose of this study is to access liraglutide influence brown adipose tissue~     recruitment and its thermogenic effect through hypothalamic activation in obese individuals.~   "
25839|NCT02718937|"~     The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585~     compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b~     virus.~   "
25840|NCT02718924|"~     Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable~     state is more evident in morbidly obese pregnant women as opposed to their non-obese~     counterparts. The aim of this study is to investigate the change in coagulation status of~     morbidly obese and non-obese pregnant women following cesarean section delivery using~     thromboelastometry. This observational study would also make it possible to calculate the~     sample size for a future prospective controlled clinical trial to compare the incidence of~     Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts.~     To the best of our knowledge, no other work has been done any in this area.~   "
25841|NCT02718911|"~     The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1~     receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in~     participants with advanced solid tumors.~   "
25842|NCT02718898|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.~   "
25843|NCT02718885|"~     The overall objective of the study is to examine the changes within the gut microbiome after~     the supplementation of inulin and its effect on markers of mineral metabolism and bone~     turnover.~   "
25844|NCT02718872|"~     This project is responsive to the identified gap of lack of tobacco cessation training~     programs in Latin American & Caribbean countries. Currently, smoking rates in the Latin~     American and Caribbean region are high, and previous surveys show that health professionals~     do not have enough skills to help smokers to quit. In consequence, in absence of trained~     health professionals, many smokers who visit health care services are under-treated. The~     Fruitful Project aims to adapt an original on-line course developed in Spain to the reality~     of the three Latin American countries (Bolivia, Guatemala and Paraguay) and disseminate~     evidence-based tobacco cessation interventions among health care professionals.~   "
25848|NCT02718820|"~     Squamous cell carcinoma of the head and neck, which accounts for 90% of head and neck~     cancers, is the tenth most common cancer worldwide with over 650000 new cases per year. The~     major risk factors for HNSCC development comprise alcohol and tobacco consumption. During~     the last decades human papilloma virus infection (HPV) has been identified to contribute to~     the development of oropharyngeal HNSCC in a subgroup of patients5. Standard treatment~     options include surgery, (chemo)radiation and chemotherapy. Despite improvements of~     treatment regimens the recurrence rate of stage III/IV disease after curative therapy is~     about 30-40%. In locoregionally unresectable recurrent or metastatic disease palliative~     poly-chemotherapy is the mainstay of therapy.The median survival time of these patients is~     6-8 months. Based on the results of the EXTREME study a combination regimen containing a~     platinum drug, 5 fluorouracil (5-FU) and weekly cetuximab has become standard of care in~     this setting. For patients, who progressed after platinum based therapy, treatment options~     are scarce. Besides platinum drugs, taxanes such as paclitaxel or docetaxel were shown to be~     of particular use in this setting. Apart from that there has been increasing preclinical and~     clinical evidence that immune-checkpoint inhibitors such as pembrolizumab might play a role~     in HNSCC. Thus, it is the aim of this study to test if the combination of docetaxel and~     pembrolizumab after platinum failure is an effective and safe regimen.~   "
25849|NCT02718807|"~     Pre-made rapid prototyping models will be used to increase patient education versus current~     methodologies.~   "
25850|NCT02718794|"~     Teaching and learning of difficult airway management are considered to be an essential skill~     in anesthesiology. As a result, doctors and nurses in anesthesia have to be vigilant in~     every step including airway assessment, equipment preparation and strategic planning of the~     process.~      During the one-year training program, nurse anesthetist students intensively study theories~     and practical skills in anesthesia, using manikins to living patients. Difficult airway~     management has become a distinguished means in the training curriculum. In addition, the~     educational tool in the anesthesia curriculum is typically simulation-based learning (SBL)~     and problem-based learning (PBL) courses. As a result, we designed a cross-over study to~     determine the learning achievement of nurse anesthetist students in difficult airway~     management. The objectives were to study the learning achievement and relative growth of~     knowledge of the two learning techniques: SBL and PBL.~      Thirty-six nurse anesthetist students in Academic Year 2015, volunteered to join the study~     project. After signing the consent form, they were randomly put into two groups: A (n = 17)~     and B (n = 19). As designed by the cross-over study, students in group A attended SBL and~     after 6 weeks, they focused on PBL, and vice versa for group B.~      The 40-item, multiple choices exam was developed in regard to difficult airway management~     guidelines. The correctness and appropriateness of the test (content validity) were~     determined by three board-certified anesthesiologists. The try out of the test was performed~     by 10 novice nurse anesthetists. The index of item objective congruence was 0.82 with Kuder~     Richardson 21 of 0.8. The assessed criterion-referenced item difficulty and discrimination~     index were 0.4-0.6 and 0.6-0.8 respectively.~      The pretest (X1, X2) were post-test ((Y1, Y2) were performed in the consequence. The~     relative growth of knowledge (G1, G2) was calculated as follows:~      G1 = 100 (Y1 - X1) / (F - X1) % G2 = 100 (Y2 - X2) / (F - X2) %~      Where F was the full scores of the learning course~      Statistics analysis The test scores and relative growth of knowledge between the two groups~     were expressed as mean and standard deviation. Comparison between the two groups was~     performed by repeated measure ANOVA. Statistically significant differences were considered~     when there was a p value of < 0.05 with a 95% confidence interval.~   "
25851|NCT02718781|"~     In recent years, Hong Kong has been undergoing rapid changes with macro social and economic~     trends. The increasingly complex and diverse family structure contribute to concerns~     regarding the well-being of families in Hong Kong, including their health, happiness and~     harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the~     increasing needs of promoting healthy active lifestyle among Hong Kong families. In this~     connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on~     FAMILY Holistic Health, will be conducted in order to increase the awareness of the~     importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components -~     train-the-trainers programs, community-based family interventions and public education~     events. It is expected that trainees from the train-the-trainers programs will acquire~     adequate skills to organize community-based health education programs effectively.~     Participants of the community-based family interventions will gain knowledge on family~     holistic health and live a healthy active lifestyle. Attendees of the public education~     events will become more aware of the importance of FAMILY 3Hs.~   "
25852|NCT02718768|"~     This is a multi-center prospective observational study that will capture detailed~     information about the treatment and long term outcomes of 450 patients with PNI resulting~     from upper extremity trauma. The study will focus on a young adult population to include~     individuals ages 18-54. Patients with PNI will be recruited during the hospitalization for~     initial treatment of the upper extremity injury. Additional patients may be identified~     during clinic visits for on-going treatment of upper extremity injuries as nerve injuries~     evolve or upon referral from outside physicians. However, all eligible nerve injuries must~     be diagnosed within 30 days of the initial upper extremity trauma. Outcomes will be assessed~     at 3, 6, 12, 18 and 24 months following diagnosis of the nerve injury. All assessments will~     take place in the clinic and will include a patient interview and a brief exam to evaluate~     sensory and motor function.~   "
25853|NCT02718755|"~     The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and~     erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed~     or refractory hematologic malignancies. The safety of these drugs will also be studied.~   "
25854|NCT02718742|"~     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation~     maintenance therapy works after cisplatin-based chemotherapy and surgery in treating~     patients with high-risk bladder cancer. Maintenance therapy, such as paclitaxel~     albumin-stabilized nanoparticle formulation, can help keep cancer from coming back after it~     has disappeared following initial chemotherapy.~   "
25855|NCT02718729|"~     Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a~     subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and~     esophageal anastomosis than the other parts of the alimentary tract due to technical~     difficulties in accessing these areas and their easily compromised blood supply.~      Anastomotic leakage is the most feared complication following rectal resection and~     anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with~     mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of~     patients.~      Anastomotic leakage leads to increase the rate of secondary interventions, re-operations,~     longer postoperative hospital stay, increased cost, and major impact on the patient's~     quality of life. In the medium to long term, patient may be unfit for post-operative~     adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself~     may increase the local recurrence, a reduction in overall survival, and a large proportion~     of patients are left with a permanent stoma.~   "
25861|NCT02718651|"~     Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation~     of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small~     cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor~     (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the~     current diagnostic tests used in the clinic are not sufficiently detailed and require a~     tumor biopsy.~      The aim of this study is to use a new diagnostic test to detect ALK rearrangements using~     next generation sequencing, which will improve the diagnosis and treatment of ALK-positive~     NSCLC patients. Furthermore, this test will be performed on blood samples, making it~     minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in~     blood can be employed as an easy accessible and comprehensive source of information to~     diagnose ALK-positive disease, but also as a means of monitoring patient response during~     treatment. Quantitation of the the amount of ALK rearrangement will give information about~     which patients benefit from treatment and when treatment is no longer effective. The project~     will be a multicenter study where blood samples will be collected every 6 weeks from~     patients treated at four major hospitals in Denmark.~      This study will benefit future patients with lung cancer, as it will improve both the~     monitoring and evaluation of their treatment. Monitoring patients during treatment will~     provide more knowledge of disease progression and the effect of ALK-TKI treatment,~     contributing to a greater selection of patients, who will respond to treatment. This will~     potentially allow effective treatment to continue longer than with conventional methods~   "
25862|NCT02718638|"~     Oxidative stress and inflammation are cardiovascular risk factors in patients with chronic~     kidney disease (CKD) undergoing hemodialysis (HD). Nuclear transcription factors play roles~     in the coordinated expression of genes involved in inflammation, such as nuclear factor~     Kappa B (NFkB) that increase the cytokines synthesis and Nuclear factor erythroid 2-related~     factor 2 (Nrf2) that increase the transcription of genes encoding enzymes of phase II~     detoxifying and antioxidant enzymes. The aim of this study was to evaluate the effects of~     resistance exercise program on the expression of transcription factors Nrf2 and NF-kB in HD~     patients.~   "
25863|NCT02718625|"~     This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of~     pressure ulcers for participants in a long-term care facility. After meeting study criteria,~     participants will be randomly assigned for application of SANTYL® or SoloSite® to their~     pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term~     care setting, the removal of dead skin (debridement) with SANTYL® resulted in more~     participants achieving complete debridement, more rapidly than when SoloSite® is used. The~     goal of the present study is to confirm the results of the earlier study, demonstrating~     superior debridement outcomes for pressure ulcers of patients in long-term care as compared~     to ulcers managed with SoloSite®.~   "
25864|NCT02718612|"~     Uraemic sarcopenia is complex, and progressive . As older persons are particularly~     susceptible to renal failure and this accelerates the physiological muscle wasting in this~     patient group. Hence sarcopenia is an important factor of functional impairment in elderly~     patients suffering from chronic kidney disease. On the other hand, overweight has become~     increasing common in dialysis patients, and is paradoxically reported to be associated with~     better survival. It remains unclear if adipose tissue in overweight in elderly dialysis~     patients is a source of proinflammatory mediators, which could contribute to protein-energy~     wasting (PEW), cardiovascular disease, and increased mortality. This study attempts to~     explore the prevalence of Sarcopenic Obesity (SO) in a cohort of hemodialysis patients with~     a more well defined criteria. In addition, this study aims to examine the association~     between sarcopenia and SO with metabolic and cardiovascular risk factors in these patients.~   "
25865|NCT02718599|"~     To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during~     hepatobiliary surgery~   "
25866|NCT02718586|"~     The aim is to test if serum level of myokines are associated with protein energy wasting,~     inflammation and atherosclerotic vascular disease among Taiwanese dialysis patients. Some~     novel myokines levels, anthropometric parameters, cardiovascular risk factors, and presence~     of endothelial dysfunction will be examined in 250 subjects. The distribution of some~     recently identified myokines such as irisin, myotatin etc levels will be studied and~     correlated markers of malnutrition, endothelial dysfunction, inflammation and insulin~     resistance. In the present study, the investigators will further follow and investigate~     whether serum myokines levels are associated with long-term mortality from all causes and~     from cardiovascular disease.~   "
25867|NCT02718573|"~     The objectives of the study are to determine the impact of interferon-free treatment for the~     hepatitis C virus (HCV) on peripheral blood immune cell phenotype and soluble immune-related~     proteins in blood, while controlling for genetic polymorphisms known to impact HCV-related~     immune responses, and to determine the impact of the therapy on the emergence of~     drug-resistant HCV. The study design is informed by the researchers recent investigations of~     patients receiving HCV treatment. About 4% of patients who had not undergone liver~     transplantation experienced hepatic decompensating or another serious event. There were~     several cases of bacterial infection and two cases with elevated markers of autoimmune~     processes. These events suggest that treatment altered immune responses. About 25% of~     patients who had undergone liver transplantation experienced hepatic decompensating or~     another serious adverse event. The long term goal is to understand the pathophysiology of~     these complications and determine whether HCV treatment can cause an immune reconstitution~     syndrome in susceptible patients, while improving antimicrobial defenses in others~   "
25868|NCT02718560|"~     The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in~     Parkinson's Disease.~   "
25869|NCT02718547|"~     The Investigators propose to examine the effect of lowering the intraocular pressure on~     macular edema in Participants diagnosed with diabetic macular edema. Our theory is based on~     the assumption that lower intraocular pressure means higher Ocular Perfusion pressure, which~     may cause an improvement in retinal perfusion and thus an improvement in retinal oxygenation~     and reduced edema~   "
25870|NCT02718534|"~     This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy~     took place within 48h with therapy took place after 48h for patients with stroke (modified~     Rankin Scale Score 3-4).~   "
25871|NCT02718521|"~     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive~     sufficient hydration before application of contrast to prevent CIN, but hydration could~     obviously increase the preload for congestive heart failure (CHF) patients. Isosorbide~     Dinitrate could reduce cardiac preload and afterload by expanding vein and artery.so~     adequate hydration therapy combined with intravenous infusion of isosorbide dinitrate could~     better prevent contrast-induced nephropathy theoretically.This prospective, randomized,~     double-blind, comparative clinical trial randomly selected 264 patients with estimated~     glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary~     angiography to receive either the convention hydration (n=200) or the hydration therapy~     combined with intravenous infusion of isosorbide dinitrate(n=200).~   "
25872|NCT02718508|"~     The objective of this trial is to test feasibility and acceptability of an e-parenting~     skills intervention with parents of injured adolescent alcohol users (12-17 years old) as~     compared to standard care at three pediatric trauma centers. To examine these questions, the~     investigators will randomly assign adolescent and parent dyads (n=75) to one of two groups.~     One group will continue to receive the institutional standard care of a brief alcohol~     intervention delivered by clinical staff to the adolescent with no parenting skills~     intervention. The second group will continue to receive the same institutional standard care~     plus the parent will receive an e-parenting skills intervention consisting of: the online~     parent training program, Parenting Wisely(PW), plus text messaging and a web-based message~     board. Study participants will be injured adolescents, 12-17 years old, admitted to the~     inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of~     first letters of key words in the screening tool) screen for alcohol use. Adolescents'~     alcohol use will be measured at study enrollment and at 3 and 6 months after discharge.~     Adolescents' alcohol related negative consequences will be measured at study enrollment for~     the 6 months prior to hospitalization and again at 6 months after hospital discharge.~     Parenting skills will also be assessed at 3 and 6 months.~   "
25873|NCT02718495|"~     This trial will consist of two parts: the first part will enroll subjects with cystic~     fibrosis (CF) of any mutation into a single ascending dose (SAD) treatment group. The second~     part will enroll adult subjects with CF of any mutation into a multiple ascending dose (MAD)~     treatment group. At least 36 subjects will be enrolled.~      The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized~     to either PTI-428 or placebo while being housed at or close to the clinical site checking in~     on Day -1 and staying through Day 4. Subjects will return to the clinical site on Day 7 for~     a final follow-up visit. The Safety Review Committee (SRC) will convene after the completion~     of each cohort to evaluate safety and other relevant data. The decision on whether to~     escalate the dose will be made for a completed cohort.~      Following the conclusion of at least 3 SAD treatment groups and after sufficient review of~     study data and approval by the SRC, a second set of adult subjects diagnosed with cystic~     fibrosis will participate in an assigned MAD treatment group. The MAD treatment group is~     comprised of at least 3 cohorts where subjects will be randomized to either PTI-428 or~     placebo while being housed at or close to the clinical site checking in on Day -1 and~     staying through Day 4. Subjects will return to the clinical site daily on Days 5-10 and Day~     12 for an outpatient follow up visit. Subjects will return to clinic on Day 14 for the final~     follow-up visit. Each dose will be administered once daily (QD) for a total of 7 Days. The~     SRC will convene after the completion of each cohort to evaluate safety and other relevant~     data. The decision on whether to escalate the dose will be made for a completed cohort.~   "
25874|NCT02718482|"~     Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the~     Ifosfamide treatment of patients with relapsed osteosarcoma~   "
25875|NCT02718469|"~     The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the~     strength of the immune response.~   "
25876|NCT02718456|"~     The study will evaluate interventions to improve engagement in HIV care following HIV~     diagnosis through a voluntary counseling and testing program. The specific aims are to (1)~     determine if a VCT-based intervention of CD4 count testing, alone or in combination with~     peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the~     intervention on ART initiation. The study will recruit 450 HIV-positive individuals from~     VCTs and randomize a third to standard counseling and referral, a third to receive CD4~     testing at the VCT with results return by phone after 1 weeks, and a third to receive the~     same CD4 testing combined with peer counseling. These combined investigations will create a~     comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new~     interventions to achieve measurable outcomes in applied settings.~   "
25877|NCT02718443|"~     VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine~     safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA~     vaccine VXM01~   "
25878|NCT02718430|"~     Phase I study in patients with metastatic colorectal cancer with liver metastasis under~     second or third line therapy to examine safety, efficacy, and immune biomarkers after~     treatment with VXM01~   "
25879|NCT02718417|"~     This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of~     avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients~     must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian~     (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for~     platinum-based chemotherapy.~      The primary purpose of the study is to demonstrate if avelumab given as single agent in the~     maintenance setting following frontline chemotherapy or in combination with~     carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by~     observation in this population of newly diagnosed ovarian cancer patients.~   "
25880|NCT02718404|"~     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla~     MR-HIFU device for treating painful bone metastases.~   "
25881|NCT02718391|"~     This phase II, randomized, open-label trial aims to assess whether the vaccination increase~     RFS in disease free melanoma patients after surgery. Patients will be randomized between~     Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or~     homogenate (6 vaccines every 4 weeks) and observation.~   "
25882|NCT02718378|"~     The current study is designed as a phase Ib multiple dose study to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral~     administration for 28 days.~   "
25883|NCT02718365|"~     The purpose of this study is to evaluate whether the long-term outcome and safety of wedge~     resection are comparable to segmentectomy for the surgical treatment of early stage (IA)~     non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and~     suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected~     population of patients with Stage I NSCLC. However, one critical question needs to be~     addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al.~     reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge~     resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the~     mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO~     nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that~     the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive.~     Therefore, these lesions are potential candidates for wedge resection. This randomized~     clinical trial is to assess whether wedge resection can be established as a standard~     treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.~   "
25884|NCT02718352|"~     Many buprenorphine treatment programs do not have services dedicated to adolescents and~     young adults. As a precursor to developing and evaluating an adolescent and young adult~     buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year~     prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT~     Adolescent and Young Adult Suboxone Program~   "
25885|NCT02718339|"~     Prospective randomized clinical trial to assess the effect of in-hospital intensive~     counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.~      The study population will include asthma patients admitted to internal Medicine departments~     and medical ICU at Soroka University Medical Center, due to asthma exacerbation.~   "
25886|NCT02718326|"~     The primary objective of the study is to assess the efficacy of intravitreal (IVT)~     aflibercept compared to sham treatment in the improvement of moderately severe to severe~     nonproliferative diabetic retinopathy (NPDR).~   "
25887|NCT02718313|"~     The purpose of this study is to investigate the type of the cardiac disease using~     transthoracic echocardiography in patients whose preoperative electrocardiography shows the~     intraventricular conduction delay.~   "
25888|NCT02718300|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.~   "
25889|NCT02718287|"~     This is a cluster-randomized study of a home visiting program targeting mothers of children~     0 to 2.5 years of age with the objective of improving global child development. The program,~     Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the~     poorest Region (V) of the state of Fortaleza, Brazil.~   "
25890|NCT02718274|"~     The aim of this project is to investigate the feasibility, affordability as well as the~     health and social impact of introducing HIV self-testing to rural communities through~     existing community-based volunteer services.~   "
25891|NCT02718261|"~     Data show that episodes of bleeding may often be observed in critically ill patients with~     dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a~     clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease~     (ESRD) may be considered a high risk population in regard to e.g. development of~     gastrointestinal (GI-) bleeding.~      In the current prospective subanalysis SIREN of the randomized placebo-controlled clinical~     trial SUP-ICU (NCT02467621), the investigators seek to elucidate whether the subpopulation~     of critically ill patients with dialysis-dependent acute renal failure benefits from~     prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.~   "
25892|NCT02718248|"~     To refine a novel intervention using a combination of a smart phone application with best~     practice psychotherapy for men who have presented to hospital with intentional self-harm.~     The outcome will be change in baseline of scores on a depression rating scale the PHQ-9 at~     six weeks. Moreover, the investigators will ask clinicians and participants about the~     acceptability of the intervention and the acceptability of using routine data sources as~     outcome measures. This will inform methods of recruitment for the larger cluster randomized~     controlled trial and the creation of a treatment manual.~   "
25893|NCT02718235|"~     With this prospective, multicenter trial the investigators aim to establish the~     Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective~     study, as a new tool for risk stratification of patients after resection of hepatocellular~     carcinoma that can be widely used in the clinical practice. The investigators expect to show~     that this score is a prognosticator for overall survival and also disease free survival.~     Further, it should be demonstrated that the HCCIS is a risk stratification tool that is~     independent from clinical or descriptive parameters. Additionally, the investigators plan to~     elucidate that the respective HCCIS risk groups are not only different with respect to~     immunological infiltration but are also different with respect to tumor biology. The~     finding, that tumors of the respective risk groups show different tumor biology leads to the~     assumption that different therapy strategies need to be applied. Therefore, in a~     translational approach we aim to build up a data base with HCC tumor organoids and test the~     effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS~     risk groups.~   "
25894|NCT02718222|"~     Studying the impact and performance of institutionalizing immediate post-partum IUD services~     as a routine part of antenatal counselling and delivery room services in Sri Lanka,~     Tanzania, and Nepal.~   "
25895|NCT02718209|"~     The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together~     with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in~     real time during surgery.~   "
25896|NCT02718196|"~     The specific aims of this study are : 1) To pilot test the alpha build prototype of the~     sleep training smartphone application using a sample of parents looking for sleep training~     advice online. 1a) To assess the efficacy of the application in helping parents with the~     sleep training process 1b) To assess the 'workability' of the application 2) Use feedback to~     guide the next round of development with the goal of building out the applications~     functionality and increasing usability.~   "
26090|NCT02715648|"~     The investigators propose to conduct a randomized controlled trial to evaluate whether~     administration of phenazopyridine prior to the procedure decreases office cystoscopy time.~     Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.~   "
25897|NCT02718183|"~     OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess~     the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as~     a primary outcome, and change color effectiveness in patients undergoing intracoronary~     bleaching.~      METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with~     the endodontic treatment in good condition. Patients were randomly located into two study~     groups according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide~     peroxide (n = 25).~      The intracameral bleaching was performed with a walking bleaching technique of 4 sessions~     Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL~     with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3~     vestibular and three palatine (mesial, middle and distal), in 6 opportunities:~      Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total~     proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and~     OPGL levels measured by ELISA (Quantikine®; R&D Systems Inc.).~      The color was evaluated in each session with Vita EasyShade spectrophotometer is used with~     the CIEL*a*b system to measure the total variation in color (ΔE), between the baseline and~     the different evaluation times.~   "
25898|NCT02718170|"~     Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation~     to plate and screw fixation for unstable extra-articular metacarpal fractures.~   "
25899|NCT02718144|"~     This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3~     cohort design to determine the recommended dose of estetrol for the treatment of patients~     with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of~     treatment), patients will receive further treatment for 8 weeks at their individual phase I~     dose level (phase IIa part of the study).~   "
25900|NCT02718131|"~     The current study proposes adding BMP-2 (INFUSE), an anabolic agent, at the surgical site of~     TPA repair in children with NF1, compared to a control group of patients treated surgically~     without BMP-2. The following Specific Aims will be addressed: 1) to determine if use of an~     osteogenic agent (BMP-2) at the time of surgical repair of TPA in NF1 patients will result~     in improved bone healing; 2) to document safety of BMP-2 in a pediatric NF1 population; and~     3) to collect, process, and preserve biologic specimens at the time of surgery for future~     studies.~   "
25901|NCT02718118|"~     This study is designed to evaluate the safety, efficacy, and subject and investigator~     satisfaction of 2 different injection volumes of Dysport in the glabellar lines.~        1. To determine the proportion of composite responders (based on blinded evaluator and~          subject assessments) who achieve at least a 1-point reduction from baseline in~          glabellar line severity score (GLSS) at maximum frown line on Day 30.~        2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.~        3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2~          visit (subject and blinded evaluator).~        4. To assess the subject's satisfaction with the treatment.~        5. To evaluate investigator satisfaction of treatment outcome.~        6. To evaluate subject psychological well-being.~        7. To evaluate subject age appraisal.~        8. To evaluate all adverse events during the course of the study.~   "
25902|NCT02718105|"~     Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per~     embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?~   "
25903|NCT02718092|"~     This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully~     Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic~     Ultrasound)-guided management of infected and/or symptomatic WON (Walled Off Necrosis).~      Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of~     WON in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed~     pre- procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information~     will also be collected from any subsequent hospital admissions related to their walled-off~     necrosis.~   "
25904|NCT02718079|"~     The study will be conducted on patients admitted to Department of Hepatology from Jan 2016~     to Jan 2018 at Institute of Liver & Biliary Sciences, New Delhi. Study group will comprise~     of patients with acute liver failure (ALF) who have no option for liver transplant (due to~     any reason) or have contraindications for liver transplant or have no prospective living~     donor and will be assessed for enrollment in the trial.~   "
25905|NCT02718066|"~     A Phase 1b/2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with~     Nivolumab in Patients with Advanced Solid Tumors Including Melanoma, Renal Cell Carcinoma~     (RCC) and Non-Small Cell Lung Cancer (NSCLC).~      The Primary objective of this study will be:~      • To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and~     regimen of nivolumab, to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2~     Dose (RP2D) and to evaluate frequency and severity of toxicities of this combination~     treatment~      Secondary objectives will include:~        -  To explore the efficacy of study treatment as measured by Objective Response Rate~          (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR), Duration of Response~          (DoR), Progression-Free Survival (PFS) in all patients treated at RP2D~        -  To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination~          with nivolumab administered once every two weeks~        -  To characterize the effect of HBI-8000 on the electrocardiogram QT interval corrected~          (QTc) interval.~      Dose Escalation Phase (1b) will include up to 18 patients, followed by Cohort Expansion~     Phase (2) including up to 20 patients per tumor indication at MTD and/or RP2D.~   "
25906|NCT02718053|"~     The purpose of the study is to evaluate the reliability of spasticity measurement with~     Lokomat~   "
25907|NCT02718040|"~     This study is designed to~        1. evaluate the naturalness of facial expressions in motion (2D video images), by treating~          investigator assessment~        2. evaluate naturalness of facial expressions (photographs), by treating investigator~          assessment~        3. evaluate perceived attractiveness and age of subject (2D videos), by treating~          investigator assessment~        4. evaluate aesthetic improvement, by subject and treating investigator assessments~        5. evaluate subject satisfaction~        6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment~        7. evaluate marionette lines (MLs) severity, by treating investigator assessment~        8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis~        9. evaluate all adverse events reported during the study.~   "
25911|NCT02717988|"~     This double-blind, placebo-controlled, single ascending dose study is designed to~     demonstrate safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers.~     The results of this study will guide selection of dose levels for future multiple dose~     studies in healthy volunteers and adult patients with moderately to severely active~     rheumatoid arthritis.~   "
25912|NCT02717975|"~     It is estimated that over 10% of men above the age of 60 will experience an episode of~     urinary retention over a period of 5 years and will need urethral catheter. Some of these~     patients are discharged from the hospital with urethral catheter, for them to attend a Trial~     Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after~     catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient~     get the urge to pass urine and empty the bladder.~      The main objective of this study is to see the effect of catheter valve on the length of~     clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.~      In this study after randomization, patients in Group A (catheter valve group) will be given~     a catheter valve before they are sent home with the catheter.They will be asked to close the~     valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250~     mls in bladder with natural filling) before their appointment. It is very likely that by the~     time these patients are seen in the TWOC clinic their bladder is already full and they will~     void soon after removal of catheter.The patients in Group B (control) will go home with free~     drainage catheter and urine bag (standard catheter removal). These patients on arrival, in~     the TWOC clinic will have an empty bladder when their catheter is removed, they will then~     drink plenty of fluids in the clinic and wait for their bladder to be full before they void~     spontaneously.~      This study will last for one year after approval by ethical committee.~      The time saved in this process would lessen patient anxiety, lead to more patients being~     reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.~   "
25913|NCT02717962|"~     The purpose of this phase 2, single arm, biomarker-driven study is to determine if treatment~     of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated recurrent glioblastoma with~     VAL-083 improves overall survival (OS), compared to historical control.~   "
25914|NCT02717949|"~     There still remains the question if hepatitis C eradication with all oral therapy will lead~     to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is~     that oral HCV therapy will lead to a high rate of hepatitis C eradication which will~     correlate with a reduction of the size and extent of low-grade lymphoma. The hypothesis of~     this study is that subjects with hepatitis C,regardless of genotype, who have low grade~     lymphoma, when treated for hepatitis C without pegylated interferon will have a regression~     of low grade non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of~     Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a~     subset of HCV-related low grade B cell non-Hodgkin's lymphoma~      Primary Objective This study will assess the safety, as measured by adverse events, in~     subjects receiving hepatitis C treatment.~      Secondary Objective The secondary objective of this study is to assess the rate of overall~     response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete~     response according to revised international working group criteria for non-Hodgkin lymphoma.~      Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in~     subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and~     serious adverse events. In addition, the study will assess the number of subjects who had to~     stop treatment due to adverse events or serious adverse events. The study will also examine~     the number of subjects in which treatment for lymphoma had to be given due to clinical~     progression.~      Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of~     overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or~     complete response according to revised international working group criteria for non-Hodgkin~     lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade~     lymphoma.~   "
25915|NCT02717936|"~     Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool~     using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared~     to regular H&E staining. The investigators therefore plan to include 73 participants with a~     confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.~   "
25916|NCT02717923|"~     This is a single arm, open-label clinical trial to evaluate the efficacy and safety of~     maintenance treatment with capecitabine plus cetuximab after first-line modified~     fluorouracil, leucovorin, and oxaliplatin(mFOLFOX6) plus cetuximab for patients with KRAS~     wild-type metastatic colorectal cancer.~   "
25917|NCT02717910|"~     This feasibility study evaluates acceptability and preliminary effectiveness of a digital~     health game as an intervention supporting tobacco-related health literacy in 10- to~     13-year-old early adolescents. One third of the study participants will receive the health~     game, on third a web page with similar content and one third will act as a control group~     without intervention.~   "
25918|NCT02717897|"~     The purpose of this study is to test blood and tissue samples of people with Ulcerative~     Colitis (UC) to see what effects vitamin D may have on the immune system. This research is~     being done because it could lead to the development of new treatment for people with~     inflammatory Bowel Disease (IBD).~   "
25919|NCT02717884|"~     The objective of the phase I part of the trial is the determination of the maximum tolerated~     dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic~     acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose~     (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or~     who failed azanucleoside treatment.~      The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP~     at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for~     further investigations of TCP~   "
25920|NCT02717871|"~     To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious~     keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and~     early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.~   "
25921|NCT02717858|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effects of~     liraglutide on gallbladder emptying in overweight and obese subjects.~   "
25930|NCT02717741|"~     Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular~     Endothelial Growth Factor Receptor (VEGFR).~      This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and~     preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study~     are conducting in Cancer Hospital Chinese Academy of Medical Sciences.~   "
25985|NCT02717026|"~     Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal~     vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial.~     Different imaging modalities might provide divergent results. Thus, quantification of such~     differences is valuable.~      The present study aims to reveal and quantify differences in vessel morphology between~     fundus photography, fundus angiography, and optical coherence tomography in health and~     disease.~   "
38351|NCT02555046|"~     The purpose of this study is to determine the effect of General versus Local Anaesthesia on~     muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised~     controlled trail.~   "
25922|NCT02717845|"~     Malalignment of the knee joint causes arthritis in later life. Currently there are three~     surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and~     high tibial osteotomy (HTO). The former two very much focus on treating the effect of~     malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the~     arthritis, namely the joint malalignment. This preserves the patient's joint and it means~     that a patient will start using the unaffected part of the knee joint more.~      HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the~     knee joint, to redistribute load from the affected medial part to lateral part. To keep the~     tibia in the new position, a medical nail device is attached to keep it in place and allow~     new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix~     (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at~     surgery and therefore the change in bone angle cannot be changed afterwards. It does mean~     that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new~     CE-marked device is being tested in an interventional trial; it is produced by Ellipse~     Technologies. This device is an extendable nail and inserted intramedullary; following~     surgery the nail is tend slowly extended over a period of time until the bone correction is~     satisfactory.~      The CISKO imaging study will assess whether there is a difference between the TomoFix and~     Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at~     3 and 6 months post-operatively. This will be quantified by two independent radiological~     reports. A secondary objective is to investigate patient satisfaction and also patient pain~     levels at these time intervals. The degree of bone healing is usually the main factor~     holding clinicians back when it comes to advising patients on what activities they can~     return to post-operatively. A difference in bone healing between the two systems may impact~     on the advice clinicians can give patients regarding recommencing more intense activities~     such as recreational sports, which ultimately could positively impact patients' health and~     well-being.~   "
25923|NCT02717832|"~     The overall goal of this project is to identify factors that protect some obese adults~     from becoming insulin resistant. Identifying mechanisms that help protect some obese adults~     from developing insulin resistance could lead to novel, targeted therapeutic and/or~     preventative strategies for obese adults who are insulin resistant.~   "
25924|NCT02717819|"~     The purpose of the study is to investigate if an increased protein intake, in the form of a~     protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance~     training, offered during hospitalization and 12 weeks post discharge, in older patients.~     This will in part be evaluated from measures of muscle strength, muscle mass and physical~     functioning. Also, the study population's acceptance of the intervention product will be~     assessed along with measures related to 'cost-effectiveness'.~      A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis~     (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to~     see if it is possible to track changes in lean body mass. In addition, the reliability of~     the bio-impedance analyzer will be evaluated.~      Also, the prevalence and classification of sarcopenia will be assessed at baseline, and~     correlations to nutritional status will be investigated (n=120).~   "
25925|NCT02717806|"~     The PATHway system is designed to help patients remain physically active and maintain a good~     cardiovascular health. It proposes a novel approach that aims to empower patients to~     self-manage their CVD, set within a collaborative care context with health professionals.~     This will be achieved via a patient-centric holistic approach that specifically addresses~     the above barriers. It involves an internet-enabled and sensor-based home exercise platform.~     It is represented by several modules with an exercise module as the core component which~     will provide individualized rehabilitation programs that use regular, socially inclusive~     exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle~     intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable~     patients to both better understand and deal with their own condition and to lead a healthier~     lifestyle in general.~      The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle~     and health related physical fitness and cost-effectiveness of the PATHway intervention in~     patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).~   "
25926|NCT02717793|"~     1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer~     are popular method of measuring muscle strength. The types of muscle contraction involved in~     both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital~     dynamometer involves isometric muscle contraction (IMMC). There are several risks involved~     in measurement of 1RM, such as delayed onset muscle soreness (DOMS) and unsafe for~     pathological joints etc, this can be reduced if IMMC is used in measuring strength. Though~     both cannot be equated as they are different type of contraction, therefore the purpose of~     this study was to compare between 1RM measurement and isometric MVC using a digital~     hand-held dynamometer in healthy females. Twenty nine young females (mean age = 20.77 ±~     1.28) without any weight training experience (mean BMI = 20.43 ± 1.85) volunteered for the~     study. It was a crossover trial where 48 hours of rest period was given between each~     measurement technique. The result showed moderate correlations (r = 0.365-0.847) between 1RM~     and MVC. A simple linear regression analysis revealed a significant estimated regression~     equation for dominant and non-dominant hands. [Dominant, Y=0.391x + 1.472; Non-Dominant,~     Y=0.251x + 2.629; (Y: 1RM, x: Isometric)] with low standard error of estimation value of~     (Dominant, 0.74; Non-dominant, 0.80). The result also showed no significant difference~     between these derived equations and Brzycki 1RM prediction equation. Therefore, it was~     concluded that both prediction equations can be used interchangeably to predict the strength~     of a person, and thus IMMC can be used to predict 1RM in healthy females.~   "
25927|NCT02717780|"~     The investigators aim to assess the respiratory effect of short half-life agents in balanced~     anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea~     syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane~     versus a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory~     portable polygraphies: the night before the surgery ; the first night following the surgery~     ; the third night following the surgery.~   "
25928|NCT02717767|"~     The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of~     white corpuscles is altered during pneumonia. In presence of bacterial growth on lung~     samples, the measure of autofluorescence of white corpuscles could help the clinicians to~     discriminate bacterial colonization from acute infection.~   "
25929|NCT02717754|"~     This multi-center, randomized, double-blind, multiple-dose, placebo-controlled,~     parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its~     carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized~     to receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered~     intravenously twice daily (BID). The anticipated time on study treatment is 5 days.~   "
26009|NCT02716714|"~     This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp~     & 0.05% on trunk and extremities in Korean patient with actinic keratosis.~   "
25931|NCT02717728|"~     There is currently no standard of care or best practice for managing post-operative pain for~     patients undergoing hip arthroscopy. Perioperative pain with these procedures can be~     substantial. It has been shown that up to 90% of patients in the Post-anesthesia care unit~     (PACU) following hip arthroscopy report pain scores of 7/10. Poor pain management following~     hip fracture surgery directly results in increased time spent in high cost health care areas~     and delayed time to ambulation. Continuous regional anesthesia following hip arthroplasty~     has been shown to reduce narcotic consumption and related side-effects (reduction of~     post-operative pain, delirium, and length of stay).~      The purpose of this research is to evaluate the effectiveness of a fascia iliaca nerve block~     in reducing post-operative pain within the first 24 hours following hip arthroscopy.~     Additionally, the pharmacokinetics of the drug ropivacaine will be studied via laboratory~     analysis of blood samples. Ultimately, the objective of this research is to develop a~     standard of care or best practice for the management of post-operative pain following hip~     arthroscopy. This study will include the entire age range of patients who are seen for hip~     arthroscopy at Boston Children's Hospital, for which there is a 35 year age limit. Both~     sexes will be included in the study.~      The study design will be real catheter versus a sham catheter(control). All subjects will~     receive general anesthesia. The catheters (real or sham) will be administered after the~     induction of general anesthesia and before the beginning of the surgery until 24 hours after~     recorded PACU admittance time. The anesthesia team placing the block will not be blinded.~     The orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or~     presence of a real catheter. In the case of a sham catheter, the anesthesia team will rig a~     pump to look like it is dispensing local anesthesia.~      To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block,~     following induction of general anesthesia, a large bore IV catheter will be inserted for the~     purpose of blood draws (all patients).~   "
25932|NCT02717715|"~     This study aims to determine the effect of a supervised home-based physical fitness program~     on the aerobic capacity, quality of gait and health related quality of life in people with~     chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term~     lifestyle change will be investigated.~   "
25933|NCT02717702|"~     Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death~     in America. Cardiac stress testing is currently the best test to non-invasively identify~     which patients might be having ACS and may need more invasive testing such as a cardiac~     catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of~     the blood vessels of the heart). However, stress tests require imaging by highly trained~     specialists and even then may not correctly categorize a small minority of patients being~     evaluated for ACS.~      Advances in blood tests may now allow detection of the very early stages of heart blood~     vessel blockage via a simple blood test. The investigators seek to determine whether these~     blood tests can help to better identify patients with ACS. The study will also store any~     extra blood sample that may be left over for future use.~   "
25934|NCT02717689|"~     This study explores if a composite biomarker strategy predicts exacerbation risk in patients~     with asthma on high dose inhaled corticosteroid (+/-long-acting beta agonist) treatment and~     to evaluate the utility of this composite score to facilitate personalised biomarker~     specific titration of corticosteroid therapy in this population.~   "
25935|NCT02717676|"~     Previous studies concluded that striae gravidarum assessment appears to predict the~     occurrence of perineal tears and recommend training the health personnel to calculate the~     total striae score which can help them decide if episiotomy is to be given or not.~     Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for~     the same is still debatable as episiotomy in itself is associated with morbidity. the~     hypothesis is episiotomy done in patients with high score will definitely protects against~     perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum~     score could predict occurrence of tears during labor or not, and if episiotomy will prevent~     perineal tears in women with high score.~   "
25936|NCT02717663|"~     The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions~     and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm~     randomized factorial trial to increase MVPA adoption and maintenance among inactive adults.~     Using neighborhood walkability and socioeconomic status, participants will be recruited from~     four neighborhood types: high walkable/high SES, high walkable/low SES, low~     walkable/high SES, and low walkable/low SES. We will evaluate synergistic or antagonistic~     effects of interventions and neighborhood factors on MVPA adoption by 12 months and~     maintenance by 24 months.~   "
25937|NCT02717650|"~     Exercise testing has become clinically important in the management and ongoing evaluation of~     patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation~     previously linked to lower mortality risk (1).~      Lower exercise capacity generally correlates with more severe lung disease (2,3) and~     landmark studies suggest that low exercise capacity as measured by peak oxygen capacity~     (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality~     (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable~     predictors of maximal exercise capacity (5), especially in relatively well preserved lung~     function (6,7).~      The wide distribution in physical capacity between fit individuals and end stage disease~     adds to complexity of assessment. Independent factors of age, genetics, habitual exercise,~     nutritional status and musculoskeletal conditions are all known to influence physical~     capacity in patients with CF (8,9).~      Maximal exercise testing places additional stress on cardiovascular, respiratory and~     peripheral systems providing more information around multiple influences on disease~     progression including degree of limitation in these major systems (10,11) and is useful for~     assessment of exercise desaturation, more common (but not always present) in advanced lung~     disease (5,12).~      With prediction of exercise performance and functional capacity from PFTs unreliable and the~     understanding that health status correlates better with exercise tolerance there has been an~     increase in maximal exercise testing for patient management (13). Many international centers~     now regard exercise testing as highly important with many assessing maximal exercise~     capacity annually to monitor disease progression, identify physical status and drive changes~     in medical, physiotherapy or nutritional management (14,15).~      The main vision is to develop a standardized incremental step test protocol suitable for~     adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in~     line with current exercise testing recommendations (15). To develop a more useful field test~     to assess exercise tolerance and a more user friendly test than the currently available~     laboratory exercise test to allow for early detection of decline in physical function in the~     day-to-day clinical setting. To date no studies have been published in adults with CF where~     an incremental exercise step test has been investigated to assess exercise tolerance or~     determine maximum oxygen uptake (VO2max).~   "
25938|NCT02717637|"~     All patients undergoing an elective caesarean section under spinal anesthesia will,~     according to the hospital routines, receive 10 mg oxycodone slow-release tablet when~     arriving at our postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1~     hour, 2 and 6 hours after administration in order to investigate bioavailability.~   "
25939|NCT02717624|"~     To characterize the safety profile of acalabrutinib in combination with bendamustine and~     rituximab in subjects with treatment naive and relapse/refractory Mantle Cell Lymphoma (MCL)~   "
25940|NCT02717611|"~     A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects~     with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy~   "
25950|NCT02717481|"~     Examine a new method based on fusion between ultrasound (US) and previous~     ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm~     and measure the changes over time and following invasive repair procedure.~   "
26091|NCT02715635|"~     The principal research objective is to determine whether inorganic nitrate in the form of~     beetroot juice compared to placebo control prevents the systemic inflammation that underlies~     typhoid vaccine-induced endothelial dysfunction~   "
25941|NCT02717598|"~     Background:The optimal technique for removal of diminutive or small colorectal polyps is~     debatable.~      Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot~     snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).~      Design：Prospective randomized controlled study. Setting：Three tertiary referral hospitals.~     Patients：we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were~     randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a~     computer-generated random sequence. If a patient had one or more polyps, all eligible polyps~     were removed using the initially assigned polypectomy protocol. After the initial~     polypectomy, additional EMR was performed at the polypectomy site to assess the presence of~     residual polyp tissue.~      Main Outcome Measurements:The primary study outcome was to compare the complete polyp~     resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse~     events, including bleeding, perforations,infection and rate of tissue retrieval(Complete~     resection was defined as the absence of residual polyp tissue in the EMR sections of the~     polypectomy site).~   "
25942|NCT02717585|"~     Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep~     disorders. In fact, insomnia and waking unrefreshed are currently considered part of the~     criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are~     inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by~     repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep~     and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or~     co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical~     trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang~     questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After~     undergoing further baseline questionnaires and investigations, patients confirmed to have FM~     with moderate to severe OSA will be randomized to one of two different treatments: 1)~     Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway~     Pressure (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the~     Chronic Pain Clinic only.~   "
25943|NCT02717572|"~     In the current study, the investigators plan to expand the knowledge of Positron Emission~     Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of~     fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent~     diffusion coefficients (ADC) measurements, in a broad population of patients with malignant~     solid tumors.~   "
25944|NCT02717559|"~     In this study the investigators will examine patients who have undergone unilateral ACL~     reconstruction surgery to determine which structural and functional characteristics of the~     knee two and ten years post reconstruction surgery, aspects of the original injury and~     repair, and patient characteristics are risk factors for osteoarthritis after ACL~     reconstruction surgery.~   "
25945|NCT02717546|"~     The objective of this observational prospective study is to systematically document the~     clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied~     to distal tibia fracture treatment and confirm safety and performance of the screws.~   "
25946|NCT02717533|"~     The objective of the proposed study is to demonstrate that serial blood volume analysis~     (BVA) using RI-BVA (BVA-100, Daxor, NY) can be used to guide changes in prescription of dry~     weight for hemodialysis patients. The knowledge of a patient's ideal BV and degree of~     hypervolemia using these measurements can be used to change the prescription of DW in an~     objective way instead of the current standard of practice, which is based on subjective~     prescription of dry weight. A first study was conducted to determine the rate of plasma~     volume (PV) re-expansion for each patient as a guide to rate of fluid removal (results~     published, refer to citations). A second study was conducted in order to assess the value of~     a BVA measurement in guiding prescription of clinical DW. A follow up BVA would then be done~     in order to check if patients were closer to ideal BV than prior to changing dry weight.~   "
25947|NCT02717520|"~     The primary objective of this study is to evaluate long-term clinical performance of a glass~     hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five~     years. The secondary objective is to evaluate the suitability of intraoral impressions for~     the assessment of wear of teeth and restorative materials over five years. For that purpose~     the replica method and scanning 3-D laser equipment and matching software will be used.~      The first null hypothesis is that there would be no difference in clinical performance~     between restorative materials after five years. The second null hypothesis is that wear~     between the restorative materials will be the same after five years.~      This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and~     Serbia. Eligible participants are all adults aged 18 or over with indication of restorative~     treatment on vital teeth in posterior molar region, limited to two surface in a healthy~     subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal~     contact with teeth indicated for restorative treatment, severe bruxing and unstable~     physiological or medical health, pregnancy and lactation, radiation therapy or using drugs.~     Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin~     material Tetric EvoCeram) each of which will be localized on molar teeth on either side of~     the mouth. Two independent examiners will evaluate the restorations at each site one week~     after placement and at one, two, three, four and five years according to the FDI criteria.~     After, three and five years recall, impressions of both restorations is taken and the casts~     is analysed by a 3D laser scanner.~   "
25948|NCT02717507|"~     This randomized phase IIb trial studies how well low-dose carvedilol works in preventing~     heart failure in cancer survivors exposed to high dose anthracyclines for management of~     childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much~     greater risk for developing heart failure compared to survivors who didn't get any~     anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened~     and can't pump blood as well as it should. Carvedilol may help lower the risk of~     cardiovascular complications.~   "
25949|NCT02717494|"~     The purpose of this study is to determine the safety, reactogenicity, immunogenicity,~     transplacental antibody transfer and interference with infant responses to childhood~     vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10)~     or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.~   "
25962|NCT02717325|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
25951|NCT02717468|"~     In high-risk patients, it is now recommended to guide the intraoperative volume replacement~     via the stroke volume.~      Today, the most commonly used technique for estimating the stroke volume is the arterial~     waveform analysis in the radial artery. This technique has the disadvantage of being~     invasive and increasing the time dedicated to anesthesia during the surgery.~      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has~     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac~     output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of~     blood pressure by this technique was validated in cardiothoracic surgery but studies about~     monitoring cardiac output or stroke volume are inconclusive and contradictory.~      The objective of this study is to compare the use of non-invasive monitoring of stroke~     volume by Clearsight® with the arterial waveform analysis in the radial artery by~     Pulsioflex® in major surgery.~   "
25952|NCT02717455|"~     This phase I trial studies the side effects and best dose of panobinostat in treating~     younger patients with diffuse intrinsic pontine glioma that is growing, spreading, or~     getting worse (progressive). Panobinostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
25953|NCT02717442|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
25954|NCT02717429|"~     The investigators propose to conduct a randomized feasibility study of mindfulness~     meditation training (MMT) relative to an active cognitive training control group and~     waitlist control group in improving emotional regulation in individuals with MS. Individuals~     will complete pre- and post-assessments of emotional functioning through a week of daily~     diary entries, as well as self-report measures and a behavioral paradigm. Additionally, all~     participants will complete an evaluation of neuropsychological functioning, before and after~     intervention.~   "
25955|NCT02717416|"~     Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital~     admission, and has significant associated morbidity and mortality, especially in the~     elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of~     non-variceal bleeds settle with conservative measures, endoscopic therapy is the established~     method for treating those bleeds for which this is not sufficient. Despite advances and~     increased expertise in managing upper gastrointestinal bleeding, the associated mortality of~     up to 15% has remained unchanged for several years.~      EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper~     gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in~     non-variceal upper gastrointestinal bleeding. This is a single center, prospective study.~   "
25956|NCT02717403|"~     Objectives:~      The overall goal of this study is to use the principles of chronic disease management to~     develop and test an online social networking intervention using the FB platform in a~     randomized controlled trial. Our specific objectives are as follows:~      Aim 1: To develop and establish an independent closed community in FB for patients with~     rheumatoid arthritis, providing an educational platform for disease self-management and the~     potential for engaging in social networking with peers (Phase 2).~      Objective 1. To beta test the features and navigation buttons and panels in the newly~     developed website and FB group.~      Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed~     website and FB group by patient advocates (consultants to the study) who participate as~     members of the Facebook community.~      Aim 2: To evaluate the efficacy of the FB community intervention combined with an~     educational website to improve patients' self-management (including knowledge, which is the~     primary outcome), decision making and patient-reported outcomes compared with the~     educational website alone (Phase 3). We hypothesize that participation in an online closed~     community offering evidence-based information combined with peer interaction and support~     will improve patients' knowledge.~   "
25957|NCT02717390|"~     The Investigators propose to conduct a pragmatic randomized controlled trial of 350 one to~     four year old children and their caregivers to study the effectiveness of 1) the Bright By~     Three (BB3) intervention for promoting children's language and socio-emotional development~     and 2) a modified version of the Safe 'N Sound (SNS) intervention for reducing safety~     hazards and injuries. The SNS intervention will serve as a control for the BB3 group and~     vice versa so that all study participants will receive a clinically meaningful intervention.~     In collaboration with primary care clinics that serve low-income and minority children, the~     Investigators will recruit and randomize 350 twelve to fifteen month olds and their~     parents/caregivers to one of the two intervention arms and deliver the interventions over a~     2 year period.~   "
25958|NCT02717377|"~     This study is designed to test the effects of six 5 minute microbursts of physical activity~     spread across the day as compared to either a sedentary control condition or a single 30~     minute bout of moderate intensity physical activity on cognitive function, self-reported~     energy levels, aspects of eating behavior and measures of metabolic health. The primary~     hypotheses are:~        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          afternoon cognitive function as compared to a no exercise condition.~        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          afternoon cognitive function more than a single 30 minute AM bout.~      Secondary exploratory hypotheses include~        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          self-reported energy levels, reduce orexigenic appetitive measures and improve measures~          of metabolic health as compared to a no exercise condition.~        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          self-reported energy levels, reduce orexigenic appetitive measures and improve measures~          of metabolic health more than a single 30 minute AM bout.~   "
25959|NCT02717364|"~     This study is a local, prospective, non-interventional, non-controlled, multicenter,~     observational study (regulatory postmarketing surveillance). Each physician will enroll~     patients who have received at least 1 dose of Yervoy, and each patient will be followed for~     up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy~     use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile~     of Yervoy under routine, daily practice~   "
25960|NCT02717351|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
25961|NCT02717338|"~     The purpose of this study is to determine whether enhancing blood donor competence,~     autonomy, and/or relatedness increases intrinsic motivation to donate and improves donor~     retention.~   "
25963|NCT02717312|"~     The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS~     is millions every year. CS is one of the most frequently performed operation for women. As a~     consequence many women have a scar in their uterus. Cesarean scar may be associated with~     complications in later pregnancies. In recent years there have also been a few reports~     indicating that cesarean scar could potentially be associated with menstrual disorders and~     infertility. The impact of cesarean scar defect on long term welfare or quality of life is~     not clear.~      In some women with a history of CS it is possible to recognise a defect in the site of~     previous uterotomy years after the performed CS by sonographic examination. This defect in~     the scar, also called as a niche, is a consequence of incomplete healing of the scar in the~     lower part of uterus. To date there is uncertainty relating to the factors that lead to poor~     healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later~     pregnancies are not properly known.~      The purpose of this study is to investigate the prevalence and the risk factors of cesarean~     scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility,~     further deliveries and quality of life will be investigated.~      This study is a prospective observational cohort study. Women at the age of 18-45 years who~     will give birth by elective or emergency CS will be asked to participate. Women are~     recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease~     will be excluded.~      The prevalence of scar defect will be evaluated by transvaginal sonography and~     contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and~     3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after~     the CS.~      The following definition for CS scar defect will be used: myometrial discontinuity with a~     depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical~     cavity as seen on transvaginal sonography with or without saline infusion.~      The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects~     will be asked to report the number of menstrual bleeding days once a month during 3~     consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at~     the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to~     menstruation.~   "
25964|NCT02717299|"~     The purpose of this study is to compare the patient reported outcome measures of total knee~     replacement patients who received intra operative sensor guided technique for soft tissue~     balancing to a group of patients who receive surgeon guided soft tissue balancing.~   "
25965|NCT02717286|"~     The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents~     a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed~     to evaluate the clinical survival of direct composite resin restorations in first permanent~     molars (FPMs) that are affected by MIH, comparing two adhesive systems.~   "
25966|NCT02717273|"~     This study will be to prospectively determine differences in Surgical Site Infection (SSI)~     if a prolonged course of post-operative antibiotics are used following liver~     transplantation.~   "
25967|NCT02717260|"~     Inhibition control deficits is a major risk factor in the transition to the act in suicidal~     patients. Neuroimaging studies have shown that this failure was associated with hypoactivity~     in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was~     recently shown that a noninvasive brain stimulation session applied on the PFC reduces~     transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the~     activity and connectivity of neural network connected to the stimulation site. The~     investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC~     will allow a more intense and longer lasting effect on impulsivity and cognitive control in~     healthy volunteers compared to a single session and to placebo stimulation. The~     investigators assume that this behavioral change will be accompanied by a change in brain~     activity measured by resting EEG for the patients in the active group. A more intense and~     longer lasting effect is an essential step to transfer these results to patient populations.~      The main objective is to study the effect of bilateral stimulation of the PFC by~     transcranial random noise stimulation (tRNS) on the inhibition control measured by the~     cognitive motor inhibition capacity (Go NoGo test). The secondary objectives are to study~     the effect of tRNS on verbal inhibition (measured with the Hayling test); on anxiety~     (measured with the State-trait anxiety inventory (STAI)),on angry (measured with the~     State-trait anger expression inventory (STAXI)) on verbal and nonverbal inhibition (measured~     by the Stroop test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS~     10)) and on the neuronal electrical activity measured by EEG.~   "
25968|NCT02717247|"~     Obesity is worldwide a public health problem. According to World Health Organization (WHO),~     overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million~     adults die each year. Food addiction is one of the causes of obesity that may benefit from~     new therapeutic options.~   "
25969|NCT02717234|"~     To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood~     marker of nutritional intake~   "
25970|NCT02717221|"~     The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive~     and repeatable detecting EGFR-activating mutational status.~   "
25971|NCT02717208|"~     To evaluate the safety, local tolerability and pharmacokinetic characteristics after~     administration of eye-drop HL036 in healthy Korean male volunteers~   "
25972|NCT02717195|"~     To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in~     patients with treatment-resistant schizophrenia (TRS)~   "
25973|NCT02717182|"~     Interest in patient therapeutic education (PTE) is increasing: in France PTE was included~     within the 2009 Hospital, Patient, Health and Territory law as an essential component of~     the patient healthcare pathway.~      PTE is a complex intervention: its delivery is variable and may vary according to its~     content, functioning, providers, targeted patients, environment and even its objectives.~     These differences impact the expected results and make difficult the evaluation of PTE~     interventions. To overcome this difficulty, it is essential to describe precisely the~     intervention, the processes and the implementation of PTE that are usually not known. PTE~     interventions need today a global understanding of their mechanisms constituting their~     complexity.~      CONCErTo study aims at developing a classification of the different elements composing a PTE~     intervention that can impact their results and can ensure their continued existence.~      Mechanisms implemented during PTE interventions will be analyzed by a qualitative research.~     The investigators wish to identify organizational, pedagogical, psychosocial, medical or~     contextual elements that can impact the results, the patients' participation and the~     continuity of the program.~      The perspective of this research is to improve the understanding of PTE by providing~     thorough description of the interventions. This work will help stakeholders to better~     interpret the results of their interventions, to improve the transferability, the~     implementation and finally to determine which are the elements able to improve patients'~     health status.~   "
25984|NCT02717039|"~     The purpose of this research is to identify genomic markers that can predict heparin-induced~     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly~     used to prevent blood clots and the investigators may be able to identify genomic markers~     which can be used to prevent heparin use in people who will get HIT.~   "
25974|NCT02717169|"~     Background: The interactions between human beings and wearable technology like activity~     trackers equipped with biometric sensors can be linked to health related new learning~     concepts/instructional methods supporting deep knowledge acquisition, situated,~     self-regulated and active learning. This personalized, long term interactions where specific~     information is pushed to the learner contributes to deepen the personal understanding~     related to the concept of and knowledge about health and has an impact on long term health~     action process.~      Design and methods: In order to understand the behavioural change process, a multiple case~     study including 35 higher education students in Hong Kong from an undergraduate course, BSc~     Exercise and Health is currently conducted. Each student uses a wearable device (activity~     tracker) over a period of five months, reflects weekly on emerging personal data, documents~     their thinking and action in the ePortfolio, and engages in an online forum. The~     participants enter their experiences with the biometric data, lifestyle adaptations (e.g.~     more steps), special situations (e.g. hike, heart rate changes during activity) and how~     these experiences lead to specific searches and actions on the web and/or in their real~     social network. The ePortfolio will allow the students to critically reflect on their~     progress and for the researchers to intervene at any time on the issues related to the~     participants' postings. EHealth literacy is used as indicator for the health action process~     of the participants. Evidence regarding change in eHealth at the beginning and end of the~     intervention will be collected with a standard questionnaire detecting eHealth their~     literacy scale.~      Scope: By reflecting on the information from their personal activity tracker and documenting~     it in their own ePortfolio, the students will continuously learn to analyse, search and~     critically assess health related personal and available digital information, organize it,~     present and discuss it with peers/tutor. This in turn will enhance critical thinking, raise~     questions about health related topics, stimulate further inquiry deepen their knowledge~     about personal health, inducing a healthier lifestyle.~   "
25975|NCT02717156|"~     This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab~     work in treating patients with urothelial (bladder) cancer that has spread from the primary~     site to other places in the body or has come back and does not respond to certain~     chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion~     protein may be able to carry tumor-killing substances directly to urothelial cancer cells.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells~     to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab together~     may be a better treatment for patients with urothelial cancer.~   "
25976|NCT02717143|"~     Acute myocarditis is a serious illness affecting a young population with a very variable~     course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden~     death). Very few studies have examined the predictors of death and serious cardiovascular~     events in acute myocarditis and have carried on numbers of restricted patients. What little~     data results in a lack of a precise recommendation on the management and the follow-up~     period of patients.~      This observational study should identify serious prognostic factor for cardiovascular events~     in order to provide a support strategy and more appropriate monitoring of myocarditis.~   "
25977|NCT02717130|"~     An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the~     Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180-~     day Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective~     Re-hospitalization Rates while on Oral Antipsychotic Medication.~   "
25978|NCT02717117|"~     Crohn's disease (CD) is becoming more common. One of the main features of this disease is~     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems~     have a strong negative effect on the patients' quality of life but the causes of these~     problems are not well understood.~      Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals~     (called hormones) that control appetite and the movements all the gut. The investigators~     think that this control mechanism goes wrong in Crohn's patients and they have set off to do~     more research on this. Looking at the inside work of the gut has always been difficult and~     at times unpleasant for patients, however recent developments in magnetic resonance imaging~     (MRI) are allowing the investigators to study the workings of the gut in greater detail and~     without discomfort for the patients.~      Before studying the Crohn's patients it is necessary to run a set of pilot experiments in~     healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the~     gut. This validation stage of the methodology is essential before embarking in more detailed~     studies in the patients.~   "
25979|NCT02717104|"~     The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug~     Coated Balloon Catheter in a heterogeneous patient population in real world clinical~     practice.~   "
25980|NCT02717091|"~     The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and~     nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.~   "
25981|NCT02717078|"~     This study will investigate the use of a low biologically available and high protein diet~     (LoBAG) for treatment of type 2 diabetes mellitus. Subjects with type 2 diabetes will be~     recruited and asked to adhere to this diet or a control diet for 12 weeks. Food preparation~     will be done by subjects following instruction from the study team. The hypothesis to be~     tested is that the LoBAG diet will produce a significant reduction in hemoglobin (HgbA1c)~     and other markers when compared to a control diet.~   "
25982|NCT02717065|"~     Characterizing the nature and severity of tinnitus in individuals presents a particular~     challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the~     effect on quality of life. Different methods are used to measure each parameter. Loudness is~     measured using a technique called minimum masking, in which the subject is presented with~     a broadband white noise and asked to adjust the loudness level until they can no longer hear~     their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the~     Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These~     questionnaires assess the perceived severity of the tinnitus and the effect on everyday~     activities and quality of life. A visual analog scale (a scale from 0-10) is used as a~     general subjective measurement of tinnitus severity. In the first part of this study, we~     will measure each of these parameters over a series of sessions to establish a baseline~     variability for each individual.~      The second part will look at the influence of context-specific visual information on~     auditory perception. This involves watching silent videos of a person speaking, with and~     without an additional tone designed to match the subject's tinnitus. The effect of this~     audiovisual feedback on the subject's perception of tinnitus will be assessed using a~     subjective rating scale and the minimum masking task.~   "
25983|NCT02717052|"~     The study at hand is the first to investigate ketamine's SERT binding in humans, by~     utilizing the highly selective SERT radioligand [11C]DASB and positron emission tomography.~   "
26227|NCT02713867|"~     The primary objective of this study is to show that PFS (progress-free survival) rate at 6~     months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks is non-inferior~     to nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC~     (non-Sq and Sq).~   "
25986|NCT02717013|"~     This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate~     (HMB) on body composition and strength changes during weight loss. When overweight and obese~     persons lose weight, and in particular in conjunction with dietary restrictions, muscle,~     bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and~     strength, and it is thought that HMB may also preserve muscle, bone, and strength during~     weight-loss.~   "
25987|NCT02717000|"~     Rationale:~      Non-alcoholic fatty liver disease (NAFLD) is the most widespread liver disorder in Western~     society (prevalence 20-30%). It is strongly associated with overweight and obesity. The~     majority of patients have simple steatosis. However, in about 15-30% of the subjects, a~     chronic inflammatory state develops that is referred to as non-alcoholic steatohepatitis~     (NASH), which leads to an overall increase in morbidity and mortality due to the progression~     to fibrosis, cirrhosis and in some cases, hepatocellular carcinoma (HCC). The term NAFLD~     comprises both simple steatosis and NASH. Most patients with NAFLD have no or few, mainly~     aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH~     and in the end, liver-related morbidity and mortality.~      To date, liver biopsy is the most sensitive test for detecting and staging NAFLD, and is the~     only reliable method for differentiating between NASH and simple steatosis. However, the~     procedure of obtaining a liver biopsy is invasive and associated with patient discomfort,~     significant complications and high costs. In addition, liver biopsy is prone to sampling~     error and inter- and intra-observer variability, due to the small size of liver biopsy~     samples. This method is therefore not suitable for screening large numbers of subjects at~     risk, or for follow-up of patients with NASH over time. Hence, only subjects at high risk~     (usually based upon elevated aminotransferase levels, which is not specific for the presence~     of NASH) are biopsied, leading to an underestimation of NASH prevalence and undertreatment.~     Further insight into disease mechanisms and risk factors for NAFLD and in particular NASH is~     warranted, to enable early diagnosis, adequate therapy and preventive measures to improve~     health status of these individuals. Accurate and less invasive methods to evaluate NASH, and~     NAFLD, are urgently needed.~      Objective: The primary objective of this study is to establish non-invasive tools (e.g.~     biomarkers and imaging) to accurately diagnose patients with NASH. The secondary objective~     is to show an association between the levels of identified markers and disease severity.~      Study design:~      Eligible subjects will be included via the outpatient clinics Zuyderland in Heerlen, the~     Catharina hospital in Eindhoven and MUMC+ in Maastricht. A subset of eligible subjects has~     undergone a liver biopsy for clinical reasons. It is estimated that about 85% of subjects~     will be asked to undergo a biopsy for study purposes only. Liver biopsies for study purposes~     will be performed during a surgical procedure, e.g. bariatric surgery or cholecystectomy.~      Blood, faeces and exhaled air will be collected and a FibroScan (+CAP) will be performed~     during a study visit. An MRI will be performed, to estimate the degree of steatosis.~     Furthermore, anthropometric data (weight, height, abdominal and waist circumference and~     blood pressure (BP)) will be collected.~      The participants in the group undergoing liver biopsy during bariatric surgery will be asked~     permission to be approached for follow-up measurements 3 months post-surgery. As they will~     lose weight, which is associated with improvement of hepatic steatosis, this enables~     assessment of possible changes over time. A routine follow-up visit post-surgery will take~     place after 3 months. The follow-up measurements will be combined with this visit,~     minimizing the burden for the participant. The measurements will consist of blood, faeces~     and exhaled air collection and a FibroScan (+CAP) will be performed during a study visit.~     Furthermore, weight, height, BP and abdominal and waist circumference will be measured.~      Study population:~      Subjects with proven NAFLD by histology or NAFLD proven by imaging, who are undergoing~     surgery (i.e. bariatric surgery or cholecystectomy) will be asked to participate in this~     study. Furthermore, all subjects have to be between 18 and 65 years old.~      Main study parameters/endpoints:~      Non-invasive tool based on biomarkers and imaging to diagnose NASH.~   "
25988|NCT02716987|"~     The purpose of this study is to determine the relationship between TAK-831 plasma exposure~     and the extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following~     single oral dosing of TAK-831 in healthy participants.~   "
25989|NCT02716974|"~     To assess the safety of treating men with oligometastatic prostate cancer with the following~     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of~     neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local~     tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative~     stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of~     androgen deprivation. Androgen blockade will be the same throughout the course of treatment.~   "
25990|NCT02716961|"~     It is still a challenge for urologic surgeon to prevent the post transurethral resection of~     bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor.~     Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which~     contains mainstream GC treatment scheme. It is common to observe clinically moderate-high~     risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can~     eliminate remained tumor cells especially those from mucosa basal cells so as to improve the~     prognosis of patients. Our clinical trial aims to investigate whether the utilization of~     combination of GC treatment scheme and epirubicin instillation would decrease the recurrence~     of moderate-high risk NMIBC.~   "
25991|NCT02716948|"~     This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab~     in treating patients with newly diagnosed melanoma that has spread to the brain or spine.~     Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high~     dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal~     antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and~     spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment~     for melanoma.~   "
25992|NCT02716935|"~     The purpose of this study is to assess the effect of a mixture of prebiotics included in a~     food supplement on microbiota diversity and functionality, and to explore its subsequent~     effects on linear growth velocity and morbidity.~   "
25993|NCT02716922|"~     Preterm birth remains the most common cause of perinatal morbidity and mortality. A short~     cervi- cal length on transvaginal ultrasonography has been shown to be one of the best~     predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that~     cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght~     without prior PTB. However maybe the meta-analysis did not reach the statistical~     significance due to the small sample size~   "
25994|NCT02716909|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. In singleton gestations a short cervical length (CL)~     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.~      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy~     of cervical pessary has been assessed in several populations including singletons with short~     CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized~     clinical trials (RCTs) have been published, and several are ongoing. However, no consensus~     on the use of cervical pessary in pregnancy or guidelines for management have been assessed.~   "
25995|NCT02716896|"~     Currently the standard treatment of muscle invasive bladder cancer is the complete removal~     of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught~     with complications and risk of death. The researchers hope to learn if chemoradiation (i.e.~     using chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder~     cancer, can be used a good alternative therapy option.~   "
25996|NCT02716883|"~     In this study Investigators are going to do early amniotic membrane transplantation (AMT)~     for bacterial keratitis.~   "
25997|NCT02716870|"~     Fructose-containing sugars have been implicated in the epidemics of obesity, diabetes and~     related cardiometabolic disorders. This view is supported by lower quality evidence from~     ecological observations, animal models, and select human trials. Higher level evidence from~     controlled trials and prospective cohort studies have been inconclusive. Whether sugars~     contribute to cardiometabolic complications independent of their calories remains unclear.~     To address the uncertainties, the investigators propose to conduct a series of systematic~     reviews and meta-analyses of the totality of the evidence from controlled trials to~     distinguish the contribution of fructose-containing sugars from that of energy in the~     development of markers of cardiometabolic risk. The findings generated by this proposed~     knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers~     and patients, stimulating industry innovation, and guiding future research design.~   "
25998|NCT02716857|"~     The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily~     (BID) in patients with moderate-to-severe chronic low back pain~   "
26010|NCT02716701|"~     Exercise therapy in MS patients has proven benefits on mobility, mood, motor function and~     quality of life. While the beneficial effects of exercise on cardiovascular and~     musculoskeletal function are well known, there has recently been increased focus on the~     positive effects of exercise on brain structure and function. The goal of this study is to~     determine whether exercise can promote beneficial changes in brain function in MS patients.~   "
26011|NCT02716688|"~     To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older~     patients with esophageal cancer.~   "
26012|NCT02716675|"~     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)~     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG)~     persons who have sex with men, in North America, South America, and Switzerland.~   "
25999|NCT02716844|"~     Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain,~     functional status and quality of life of the patients diagnosed with osteoporosis.~      Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group~     patients joined exercise program regularly that was held 3 times a week, 1 hour a day,~     during 6 weeks with physiotherapist. Control group patients continued their normal daily~     lives without any exercise. After 7 patients quit the study for various reasons, 40 women~     with primary osteoporosis (control group n=20, exercise group n= 20), completed the study~     and were assessed at the beginning and at the end of 6 weeks. As assesment' measurements~     Tampa Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill),~     Pain Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed~     Up- Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back~     Scratch Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis~     (QUALEFFO-41), Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale~     (SLS) and Health Assesment Questionnaire (HAQ) were performed.~   "
26000|NCT02716831|"~     The purpose of the study is to test a novel, acceptance-based behavioral treatment for~     bulimia nervosa (BN) in weight-suppressed adults. This treatment is a type of individual~     psychotherapy called Nutritional Counseling And Acceptance-based Therapy (N-CAAT) that~     enhances existing cognitive behavioral therapy (CBT) for BN by incorporating~     acceptance-based behavioral strategies and nutritional counseling to help patients high in~     weight suppression (WS) reduce the biobehavioral bind of WS and eliminate BN symptoms.~   "
26001|NCT02716818|"~     This study is a parallel arm, randomised, open-label study, including dose titration and~     admissions for four overnight stays for 24-hour endocrine profiles. It will compare the~     efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement~     therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of~     6 months. Dose titration decisions in both treatment groups will be made by a central~     independent physician, blinded to the treatment arm, using information generated from the~     24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules~     throughout the study, ensuring that opportunities for optimisation and control of androgens~     are the same in both groups.~   "
26002|NCT02716805|"~     This is an open-label, multicenter, Phase 1 study of checkpoint therapy, tremelimumab and~     durvalumab, administered to subjects with multiple myeloma who are at high risk for relapse.~     Checkpoint therapy will be administered prior to and for 2 cycles post autologous stem cell~     transplant (ASCT). This will be followed by up to 6 additional monthly cycles of durvalumab~     alone.~   "
26003|NCT02716792|"~     This study will evaluate renal function in participants with metastatic bone disease due to~     breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams~     (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of~     ibandronate in the 2 groups of participants will also be compared. The anticipated time on~     study treatment is 7 months, and the target sample size is 318 individuals.~   "
26004|NCT02716779|"~     This study examined the influence of ribavirin on the initial virological response in~     treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were~     randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000~     milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon~     (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks.~     Following the initial 6 weeks, all participants received combination therapy with PEG-IFN~     alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response~     after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks~     outside of the study.~   "
26005|NCT02716766|"~     The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX)~     regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.~   "
26006|NCT02716753|"~     All couples planned for IVF will be asked to participate. After information and received~     informed consent they will be randomized into two groups.~      At the time for ovum pick up during an IVF procedure either half of the amount of seminal~     plasma or the same amount of physiological NaCl solution will be installed around the~     external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl~     solution will be prepared according to a prearranged randomization list by a technician.~      The success rate will be the number of diagnosed pregnancies and live births.~   "
26007|NCT02716740|"~     Despite the demonstrable health and quality of life benefits, there are unknowns within~     consequences of obesity surgery. Weight loss composition is poorly understood. The objective~     is to have a significant loss of body fat and a limited loss of muscular weight.~      A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and~     1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little~     loss' and is defined by a contribution of muscular weight lower than 15% of the total weight~     loss. The other one is called 'big loss' and is defined by a contribution of muscular weight~     higher than 15% of the total weight loss. Causes of these different phenotypes are unknown~     for the moment.~      Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in~     clinical situations like hepatic cirrhosis, and some populations like new born and older~     people.~      Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit~     effect on the muscular mass. That is testing the influence of the quality of protein~     consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain~     of muscle only if it is associated to regular physical training, all patients will follow a~     physical training.~   "
26008|NCT02716727|"~     Purpose: To compare the quality of impressions made with a cordless gingival displacement~     procedure versus impressions made with a corded technique. The devices and materials used in~     both procedures are FDA-approved, marketed, and will be used according to label.~      Participants: Approximately sixty (60) adult patients who are treatment planned for indirect~     restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants~     will be randomized to receive either the cordless gingival displacement procedure (Aquasil~     Ultra Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by~     impression with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale.~     Impressions will be photographed, digitally scanned, and evaluated.~   "
26013|NCT02716662|"~     The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with~     ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to~     determine if, by taking AC-1204, the body will make substances called ketone bodies.~     Further, if AC-1204 is well tolerated, the investigators want to change the amount the~     participant takes, to determine if the amount of ketone bodies in the blood increase in~     accordance with increases in the amount of AC-1204 the participant takes. The investigators~     want to do this study because when the investigators gave AC-1204 to mice with ALS, findings~     suggest the disease course is altered for the better and that the cause of this change is~     due to the presence of ketones in the blood. If AC-1204 can be proven to be safe and able to~     cause ketones to increase in the blood, the investigators will likely do subsequent studies~     to determine if the presence of ketone bodies will slow or stop the progression of the~     disease. However, this study is not designed to determine if AC-1204 will stop or slow the~     progression of ALS. It is designed to only determine if patients with ALS can tolerate~     AC-1204, if ketone bodies are produced and if the amount of ketone bodies produced increases~     with increasing dose.~   "
26014|NCT02716649|"~     In this project, we derive survival risk ratios (SRR) based on International Classification~     of Disease version 10 (ICD-10) injury codes to validate the ICD Injury Severity Score~     (ICISS) in data from four public university hospitals in India.~   "
26015|NCT02716636|"~     The purpose of the study is to investigate whether the speed of tenaculum placement affects~     perceived patient pain during office transcervical procedures.~   "
26016|NCT02716623|"~     The purpose of this study is to learn if bladder cancer patients can follow a diet and~     exercise program during treatment and whether the program will improve results of their~     treatment.~   "
26017|NCT02716610|"~     Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501~     inhaled human insulin~   "
26018|NCT02716597|"~     The role of albumin in sepsis has been controversial for decades. Although hypoalbuminemia~     has been associated with worse outcomes in sepsis, definitive evidence does not exist that~     replacing albumin in these patients improves outcomes. However, subgroup analyses from large~     clinical trials indicate that albumin may reduce mortality in septic shock, and in~     particular, may reduce the time a patient requires vasopressor support. Given this~     background, we are conducting this study to evaluate the role of albumin replacement in the~     patient with resolving septic shock to determine if albumin administration reduces the time~     a patient requires vasopressor support, reduces the time required for central line, and~     ultimately whether any potential benefit in terms of reduction of vasopressor support is~     associated with ICU length of stay and other outcomes. The approach is unique from larger~     trials of albumin in that it is a septic shock study geared at a particular phenotype of the~     patient in septic shock and evaluating a specific intervention at a specific time point in~     the course of septic shock.~   "
26019|NCT02716584|"~     Impairments in social integration, characterized by low marriage rates, few friendships, and~     a high frequency of living alone, affect the vast majority of Veterans with schizophrenia.~     The primary aim of this proposal is to test the efficacy of a novel rehabilitation treatment~     approach, engaging in physical exercise, at improving two determinants of social integration~     which are impaired in schizophrenia: cognition and affect.~   "
26020|NCT02716571|"~     This study on manufacture of MG4101 (allogeneic natural killer cell) to use for~     Hepatocellular carcinoma(HCC) after Transarterial Chemoembolization(TACE) will be harvested~     WBC(white blood cell) and plasma from healthy donors, or plasma from healthy donors by~     leukapheresis or plasmapheresis procedure.~   "
26021|NCT02716558|"~     It is a clinical trial which employs a split mouth design to assess the retention of a~     moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants~     on a representative sample of 7- 12 year old school children of a district in Belgaum,~     Karnataka, India.~   "
26022|NCT02716545|"~     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or~     chronic gastrointestinal bleeding, consequently is in dire of effective treatment. The~     investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was~     safe and effective. This trial intends to investigate the efficiency of endoscopic~     intervention to the hemorrhage due to GIVM. What more, the research tends to suggest~     standardizing clinical paths for small bowel bleeding due to GIVM.~   "
26023|NCT02716532|"~     This study will be targeting patients suffering from acute brain injury (ABI), including~     those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid~     hemorrhage (aSAH).~      This clinical study is an open-label, non-randomized, single-center, exploratory metabolic~     study.~      The primary objective is to determine changes from baseline (before enteral administration~     of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI~     patients upon Peptamen AF nutritional support.~   "
26024|NCT02716519|"~     This study is designed to assess the comparative effectiveness of SANTYL® versus standard of~     care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of~     care of an ACO. After meeting study criteria, participants will be randomly assigned to~     apply Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6~     weeks. Participants will be followed for one year from the date of randomization to assess~     ulcer status and ulcer complications.~   "
26025|NCT02716506|"~     The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse~     (POP) surgery. In this multi center study the population consists of POP operations done in~     Finland year 2015.The study is prospective and validated questionnaires are used to measure~     the symptoms of POP and the quality of life before and six months after the operation.~     Methods and complications of surgery are reported by doctors in all 40 participant~     hospitals.~   "
26059|NCT02716051|"~     Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in~     detection of nodes in patients with cell lung cancer (NSCLC).~      However, the cardiorespiratory synchronization in the MRI, allowing acquisition of~     synchronous images with breathing and heart movements should increase the sensitivity of~     detection of pathologic mediastinal lymph nodes.~      Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as~     informative as PET, while being less expensive, not radiant.~      The purpose of this study is to evaluate the performance of whole-body MRI with diffusion~     with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are~     known to be less well detected by MRI) compared to PET.~   "
26026|NCT02716493|"~     Exercise-based rehabilitation improves physical function, fatigue and quality of life in~     patients with thoracic neoplasia. Consequently, the need for rehabilitation across the~     continuum of care in oncology is growing rapidly. However, the implementation of this type~     of intervention is limited because of many barriers such as patients' symptoms and poor~     accessibility to programs. In this context, healthcare systems should develop and implement~     new approaches to dispense these services. Consequently, telerehabilitation is a promising~     strategy to improve access and adherence to rehabilitation.~      OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based~     telerehabilitation program (TELERP) with real-time physiological parameters acquisition in~     patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its~     effects on patients' functional capacity.~      METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time~     monitoring combined with interactive exercises. The TELERP included supervised (15) and~     unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3~     sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program~     adherence and satisfaction were analysed. Prior to and after the program, a six-minute~     walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to~     assess functional capacity~   "
26027|NCT02716480|"~     The goal of clinical trial is to evaluate the impact of use of health-connected devices and~     of an Internet-based Intensive follow-up on physical activity recovery during the 6-month~     period after bariatric surgery in obese patients.~   "
26028|NCT02716467|"~     Living with breast cancer and forms of treatment, among them radiation therapy can cause~     both side effects such as pain, fatigue and skin changes that affect the well-being, as~     anxiety, feelings of isolation and changes in routine, which generate existential conflicts~     and allow the origin of the spiritual anguish phenomenon, which in turn, aggravates the~     physical and emotional symptoms and the ability to fight the disease. Thus, this study aims~     to evaluate the effect of intercessory prayer on levels of spiritual distress, religious /~     spiritual coping, psychological morbidity (anxiety and depression) and amylase levels~     salivary present in patients with breast cancer radiotherapy.~   "
26029|NCT02716454|"~     This study compares the efficacy of early surgical with medical treatment in patients with~     ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal~     ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up~     pharmacological therapy.~   "
26030|NCT02716441|"~     This proposal's objective is to challenge and expand the current definition of rotator cuff~     healing by investigating tendon retraction - broadly defined as medial translation of the~     repaired tendon away from the bone with or without a defect - as a common and clinically~     predictive structural outcome following rotator cuff repair. The investigators' central~     hypothesis is that failure with continuity is a common yet unrecognized structural~     phenomenon of rotator cuff healing that is significantly and meaningfully correlated with~     clinical outcomes. The investigators' approach is to characterize tendon retraction using an~     array of implanted radio-opaque markers, and investigate its relationship to pre-operative~     tissue quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes~     in a 125-patient prospective cohort study. These patients will complete validated~     questionnaires pre- and 6 weeks post-operatively, and repeat these questionnaires as well as~     undergo MRI (repair integrity), CT imaging (tendon retraction by radio-opaque markers) and~     strength testing at 3, 6, 12 and 24 months.~   "
26031|NCT02716428|"~     Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir~     and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration~     in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.~   "
26032|NCT02716415|"~     The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and~     Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper~     dermatitis among Neonates and Infants.~   "
26033|NCT02716402|"~     The purpose of the study is to examine previously examined patients with cyanotic congenital~     heart disease to assess how many of the patients have obtained additional blood clots since~     they were examined 8 years ago.~   "
26034|NCT02716389|"~     The measurement of cervical spine range of motion (ROM) figures among the most common~     aspects of clinical diagnosis. Good reliability has been demonstrated for assessments using~     ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in~     contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in~     the sagittal plane), separating the respective components provides less reliable results.~     Current research suggest that this is due to the participants' determination of the zero~     position. This position is influenced by possible disposed treatments and, in particular, by~     the subject in case of subjective determination. The present study therefore aims to examine~     the test-retest reliability of separate ROM assessments using a bulls eye spirit meter.~      Twenty healthy participants will be included in the trial that adopts a two-armed~     randomized, crossover design. With a washout-period of one week in between, each subject~     participates in two sessions in a randomised order. In both sessions, cervical ROM~     (flexion/extension, rotation, lateral flexion) will be measured twice (with a five-minute~     wait period). In all measurements, the zero position will be determined by means of a bulls~     eye spirit level. The difference of the two sessions consists in the design of the waiting~     period. In one session, the subjects will keep the mask carrying the ultrasound markers on~     their head. In the other session, the mask will be removed during the break.~   "
26035|NCT02716376|"~     To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after~     radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian~     tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby~     better hearing and ear related quality of life after cancer treatment.~   "
26060|NCT02716038|"~     This is a research study to test the effectiveness of nab-paclitaxel + carboplatin +~     MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung~     cancer. The study aims to determine if chemotherapy combined with immune-based therapy can~     lead to improvement in tumor response rates over historical response rates with chemotherapy~     alone.~   "
27604|NCT02695849|"~     This is a non-interventional, local, multicenter, cross-sectional study to determine the~     prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed~     with non-squamous non-small cell lung cancer (NSCLC).~   "
26036|NCT02716363|"~     Current guidelines recommend the use of rotational atherectomy (RA) for preparation of~     heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or~     adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as~     one of several tools to treat luminal obstruction via physical removal of plaque. Although~     initially explored as an alternative to balloon angioplasty, RA has shown favorable acute~     results in facilitating stent delivery and adequate expansion, particularly those affected~     by heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis~     rates in randomized clinical trials evaluating simple de novo coronary artery lesions and~     have also shown favorable results when implanted in complex lesions and patients, but higher~     event rates are observed when treating such subsets compared with simple lesions even with~     newer generation DES. However, there are limited data on evaluating the safety and~     effectiveness of RA followed by DES implantation for heavily calcified lesions in~     contemporary practice. Recent randomized controlled trial shows that RA before paclitaxel~     eluting stent implantation as first generation DES was not superior to paclitaxel eluting~     stent implantation without prior RA in reducing the primary endpoint of in-stent late~     luminal loss at 9 months, indicating that RA does not increase the efficacy of DES in~     patients with moderate to severe calcified lesions. However, there were only 15 (12.5%)~     crossovers from standard therapy to rotablation because of failure of balloon or stent~     delivery or suboptimal balloon expansion despite the use of a noncompliant balloon.~     Accordingly, procedural and fluoroscopy times were longer in the elective RA and procedural~     complications occurred equally in both elective RA and bailout RA. These findings might~     cause by a substantial portion of enrolled population have moderate calcified lesions, but~     not severe calcified lesions. In particular, everolimus-eluting stent (EES) as newer~     generation DES could act synergistically in heavily calcified lesions as RA could avert~     stent coating damage and EES could effectively suppress neointimal proliferation. Therefore,~     we compare in-hospital and long-term efficacy or safety of elective RA versus bailout RA and~     low-volume operator versus high-volume operator in patients with severe calcified lesions~     treated with EES.~   "
26037|NCT02716350|"~     To investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in~     healthy adults (52-65 years old). The study will consist of a 4 month randomised double~     blind parallel treatment period with either B-GOS of Placebo, and 1 month follow up period~     without treatments.~   "
26038|NCT02716337|"~     The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants~     is of utmost importance. Standard fortification is the most commonly used supplementation~     practice but it does not consider the native variability of human milk. Data on efficacy and~     safety of prolonged target fortification are scarce. The investigators performed a~     prospective interventional study in VLBW preterm infants, exclusively fed with human milk,~     to test efficacy and metabolic safety of target fortification in these preterm infants.~   "
26039|NCT02716324|"~     The purpose of this study is to explore whether using an online patient portal plus a Care~     Manager is more effective than using an online portal alone in managing care for children~     with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online~     patient portal to help gather information from parents and teachers on ADHD symptoms,~     treatment, and medication side effects. The Care Manager is a person who meets with~     participants during the study to discuss their child's ADHD care. The Care Manager~     communicates with the child's doctor and teacher to communicate a parent's goals and~     preferences for their child's ADHD care.~   "
26040|NCT02716311|"~     Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC)~     was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal~     Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor~     (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has~     been proved in several phase III trials with gefitinib, erlotinib or afatinib.~      Nevertheless, all patients will progress after 9 to 12 months of treatment due to the~     appearance of a treatment resistance.~      Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to~     erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of~     all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof~     that afatinib delay the appearance of resistance.~      Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition~     of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The~     hypothesis of this study is that the combination between cetuximab and afatinib will permit~     to delay or decrease the appearance of resistances.~   "
26041|NCT02716298|"~     This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear~     modality over approximately 1 month in comparison to the lotrafilcon B lens.~   "
26042|NCT02716285|"~     Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS)~     symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint~     oil remains relatively under-used in IBS. Therefore, the investigators will conduct a~     multicenter randomized, placebo controlled trial to investigate the effects of an eight-week~     peppermint oil treatment in IBS patients according to current European Medicines Agency~     (EMA) / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce~     side effects, the investigators aim to study the use of a new peppermint oil formulation, a~     colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region~     specifically.~   "
26043|NCT02716272|"~     The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s)~     would delay tumor progression in patients with unresectable MPM, experiencing disease~     progression after one or two lines of chemotherapy including at least first-line with~     pemetrexed and platinum, without altering significantly the quality of life of patients.~   "
26044|NCT02716259|"~     The purpose of this study is to investigate whether basic periodontal therapy aim to reduce~     subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans,~     has an impact on the vascular function of patients suffering from established cardiovascular~     disease.~   "
26045|NCT02716246|"~     Open-label, dose-escalation clinical trial of scAAV9.U1a.hSGSH injected intravenously~     through a peripheral limb vein~   "
26061|NCT02716025|"~     Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included.~     All underwent complete clinical evaluation, laboratory investigations, upper~     gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done~     for all the included patients in addition to twenty five age and sex matched healthy control~     subjects.~   "
26062|NCT02716012|"~     This is a First in Human study of a new single agent (MTL-CEBPA) in patients with advanced~     cancer of the liver. The study is in two parts. The first part is a dose escalation in~     patients with advanced hepatocellular carcinoma or patients presenting with secondary liver~     tumours. The second part is a dose expansion study in patients with hepatocellular~     carcinoma. All participants will be refractory to or ineligible for loco-regional therapy~     including surgery, radiofrequency tumour ablation or transarterial chemoembolisation and~     sorafenib.~      MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal~     nanoparticle and is designed to activate the CEBPA gene.~   "
26046|NCT02716233|"~     A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an~     extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the~     adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering~     ASNase results in the depletion of asparagine circulating in the blood, which starves the~     leukemic cells and results in their death. But indeed the use of ASNase varies between~     protocols considering the different brands, the dose and the administration modalities.~     Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of~     reducing the immunogenicity of the native ASNase.~      This is a French prospective multicentric cohort study of children and adolescents with ALL,~     stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3~     groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).~      It aims to answer to two different issues:~        1. Randomized question: what is the best way to administer pegaspargase? A cohort of~          children and adolescents with standard or medium risk ALL will be randomized to receive~          during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of~          ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or~          1250 IU/m2 per dose during consolidation and delayed intensification according to the~          initial arm of randomization.~        2. Non randomized question: In the High/Very High Risk groups, a non randomized~          intensification of the scheme of asparaginase administration is proposed during~          induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered.~          All patients will receive 2500 IU/m2 per dose during consolidation and delayed~          intensifications.~   "
26047|NCT02716220|"~     BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute~     clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary~     artery lesions.~   "
26048|NCT02716207|"~     The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with~     CyberKnife SBRT will be evaluated.~   "
26049|NCT02716194|"~     1. To assess tolerability and safety of BAX 826 after a single infusion in previously~          treated patients (PTPs) with severe hemophilia A~        2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE~        3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)~   "
26050|NCT02716181|"~     A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Атопик~     Soothing Cream in Children with Mild to Moderate Atopic Dermatitis~   "
26051|NCT02716168|"~     Background International guidelines underline the importance of strengthening the~     coordination and continuity of cancer care. The different roles of general practitioners and~     oncologists with regard to treatment, follow-up and rehabilitation during and after cancer~     treatment are often obscure to cancer patients. Parallel courses of healthcare are often~     taking place instead of coordinated care characterized by continuity and partnership between~     care providers. Patients may feel uncertain about the health professionals' skills and area~     of responsibility. Healthcare seeking and support during and after cancer treatment may,~     therefore, be inappropriate, leaving patients feeling insecure and lost between care~     providers.The study aims to design and evaluate a new way of communication and shared~     decision-making that brings the patient, the oncologist and general practitioner together in~     a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of~     the intervention in addition to usual care will be tested in a randomized controlled trial~     at Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation,~     investigators intent to include 300 patients at the Department of Oncology and their general~     practitioners. Results and process outcomes will be evaluated qualitatively and~     quantitatively, questionnaires to patients, general practitioners and oncologists, and data~     from registers.~   "
26052|NCT02716142|"~     the aim of the study is To compare the effectiveness of rectally administered prostaglandin~     E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered~     misoprostol before myomectomy to decrease blood loss during and after the operation.~   "
26053|NCT02716129|"~     The primary endpoint of this study is to investigate the effect of adding nalbuphine to~     intrathecal morphine on quality of postoperative analgesia and Morphine related side effects~     post- cesarean delivery.~   "
26054|NCT02716116|"~     The purpose of this phase 1/2 study is to evaluate the safety, pharmacokinetics, and~     anti-tumor activity of oral AP32788 in patients with non-small cell lung cancer (NSCLC). The~     trial will be conducted in two parts: a dose escalation phase, followed by an expansion~     phase. The goal of the dose escalation phase is to determine the safety profile of orally~     administered AP32788, including the maximum tolerated dose (MTD), dose limiting toxicities~     (DLTs), recommended phased 2 dose (RP2D) and pharmacokinetic profile. Once the RP2D is~     established, the expansion phase will assess the preliminary anti-tumor activity of AP32788~     in 4 histologically and molecularly defined NSCLC cohorts. Approximately 105 patients will~     be enrolled.~   "
26055|NCT02716103|"~     In this study, the investigators seek to evaluate bone marrow and blood samples and~     treatment responses to see if Minimal Residual Disease (MRD) can be used as a predictive~     method of response to treatment in amyloidosis.~   "
26056|NCT02716090|"~     This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo®~     medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other~     half will receive Epiduo®.~   "
26057|NCT02716077|"~     Adult patients with histologically proven melanoma who will be treated with pembrolizumab~     will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG~     uptake will be correlated with lab and pathology results.~   "
26058|NCT02716064|"~     TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application~     (APP) to help patient manage their diabetes and hypertension and other chronic conditions by~     assisting them in setting goals and connecting them to their healthcare team.~   "
26063|NCT02715999|"~     The purpose of this research study is to find the best way to decrease pain in children whom~     have had low abdominal surgery. Investigators will perform two technique of trunk block;~     Transversus abdominis plane or Quadratus lumborum block .The method used is often chosen by~     which one the doctor has more experience using. The Investigator plans to find out if one of~     the methods is more effective and/or safer than the other method.~      The results of this study will help learn how to best control pain in children having~     surgery low abdominal surgery.~   "
26064|NCT02715986|"~     Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant~     depression whose effectiveness has been demonstrated. However, the brain mechanisms~     underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic~     action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of~     glial cells. In addition, functional imaging of resting state type have shown, among~     depressed patients after ECT, increased functional connectivity . These results were~     reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it~     seems appropriate to continue research neuroanatomical correlates subtending neurofunctional~     processes responsible at the same time improving the clinical depressive. The investigators~     suggest using an original technique never used in this type of population: Functional~     magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will~     allow us to study the impact of ECT on brain structures involved in major depressive~     disorder: hippocampus.~   "
26065|NCT02715973|"~     Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to~     3 yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously~     prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared~     from locally available, affordable, socially acceptable food items - milk, sugar, edible~     coconut oil, egg and custard powder as base) in addition to standard nutritional counseling~     by a trained dietician (Group A). The control group (Group B) in comparison will receive~     standard nutritional counseling from a trained dietician but will not receive any additional~     nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months,~     9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data~     will be collected at each visit. Additionally IL-6 levels will be done at each visit in~     children of both arms of the intervention group.~      The outcomes of interest will be growth and improvement of nutritional status parameters,~     hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous~     Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or~     Liver Transplantation}.~      All children will receive individualized standard treatment for infantile cholestasis~     syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP~     (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy~     wherever indicated (steroids/ copper chelation/ UDCA).~   "
26066|NCT02715960|"~     In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by~     Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases~     invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on~     the curative effect and find the relationships between genetic variants and the response of~     Acitretin Capsules to treatment of Psoriasis Vulgaris.~   "
26067|NCT02715947|"~     To investigate the influence of genetic factors on the curative effect , to find the~     relationships between genetic variants and the response of Methotrexate to treatment of~     Psoriasis Vulgaris.~   "
26068|NCT02715934|"~     Diabetes education is a very important part of diabetes care. Most people with diabetes~     receive care in primary care practices where diabetes education is not always available.~     This project tests a model designed to improve access to diabetes education services.~   "
26069|NCT02715921|"~     Fitness in patients with Cystic fibrosis (CF) is an important biomarker associated with~     higher survivability and improved quality of life. CF patients are encouraged to maintain an~     active lifestyle, however, while physicians are able to prescribe airway clearance measures~     or specific medications, there is no prescription for exercise or avenue to promote exercise~     outside the clinic or hospital.~      The advent of ubiquitous computing has transformed the landscape of healthcare delivery.~     Thus far, exercise training in CF have either required patients travel to a gym or relied on~     home visits or telephone calls. Virtual visits provide a novel and innovative platform to~     deliver a live stream of exercise sessions with two-way video and audio capabilities,~     allowing individualized attention to exercise for CF patient from the comfort and privacy of~     their homes. Applications of tele-exercise, or tele-rehabilitation, have been shown to be as~     effective as in conventional physical therapy following orthopedic surgeries and, in stroke~     patients, to optimize patient outcome by prolonging duration of treatment and preventing the~     observed decline after the termination of therapy. For CF patients, the latter is especially~     important given the impact of hospitalizations for acute exacerbations on exercise~     tolerance. In this particular population, where cross-contamination risks limit use of group~     exercise activity, using two-way video telecommunication allows participation in exercise~     programs while adhering to the standards of CF management regarding infection control.~      This study would be the first to evaluate implementing tele-exercise and remote monitoring~     program on pediatric CF patients. Our pediatric CF patients will be enrolled in a six-week~     exercise program that is streamed live from an instructor into their computers at home via a~     HIPAA compliant telemedicine platform. Remote monitoring devices, such as accelerometers and~     wireless heart rate monitors, will evaluate baseline habitual activity and intensity of~     exercise, respectively. The goal of this study is to show that tele-exercise program is a~     feasible and convenient and cost-effective method to enhance CF care for our patients.~   "
26070|NCT02715908|"~     To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg~     subcutaneous weekly injection when co-administered with MTX~   "
26071|NCT02715895|"~     Compared with breast milk and another commercially available formula, infants' growth rate~     after 12 weeks' Friso formula with different ways of processing feeding will be assessed.~   "
26072|NCT02715882|"~     Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of~     CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses~     and Regimens~   "
26073|NCT02715869|"~     Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the~     heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).~   "
26074|NCT02715856|"~     The goal of this study is to learn about performing follow-up care using mobile devices~     (smartphones or tablet computers) after surgery.~   "
26075|NCT02715843|"~     This is an active treatment, extended access study open solely to those subjects who have~     successfully completed the Core and Repeat Dosing portions of the MT-3724_NHL_001_US~     clinical study and who, in the investigator's judgment, (i) have not had progressive disease~     while on MT-3724 treatment (i.e.; have shown a complete or partial response or stable~     disease), (ii) have experienced no clinical or laboratory toxicities that would~     contraindicate further MT-3724 dosing and (iii) have no acceptable and better alternative~     treatment available to them.~   "
26076|NCT02715830|"~     It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in~     which 40 procedures to treat one artery (standart) or more than one artery in the same~     procedure.~      The aim of this study is to know if this strategy increase healing velocity and limb~     salvage.~   "
26078|NCT02715804|"~     The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant~     Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment),~     compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in~     participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal~     adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.~   "
26079|NCT02715791|"~     The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by~     strengthening connections between patients and the primary healthcare system through health~     connectors -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and~     McMaster Personal Health Record (PHR). It will explore whether strengthening primary care~     connections across patients, providers, and community organizations through TAPESTRY-HC-DM -~     i.e., the deployment of volunteer health connectors coordinated by a community organization,~     the use of the TAPESTRY Healthy Lifestyle e-Application by patients, and care coordination~     processes by the interprofessional primary healthcare team - can increase self-efficacy in~     managing chronic conditions.~   "
26080|NCT02715778|"~     Although the last decade has brought major advances with respect to our knowledge of certain~     risks associated with fetal exposure to psychiatric medications, critical information~     regarding the long-term neurobehavioral impact of fetal exposure is lacking. With a~     prevalence rate of selective serotonin reuptake inhibitor (SSRI) use across pregnancy in~     Western countries noted to be as high as 5-8%, this study aims to close the gap in knowledge~     regarding long-term neurobehavioral sequelae of in utero exposure to this class of~     antidepressants. Importantly, the assessment of the impact of antenatal psychotropic~     medication use must be conducted with an appreciation of the potential direct and indirect~     effects of maternal psychiatric illness during pregnancy and throughout childhood. The~     outcomes of this study will help to inform the care of reproductive age women treated with~     psychiatric medications as they, along with the clinicians prescribing for them, weigh the~     relative risks of using these agents during pregnancy.~   "
26081|NCT02715765|"~     Schizophrenia is a serious mental health disorder that affects approximately 1% of the~     population. Auditory hallucinations are present in as many as 50-75% of patients with this~     diagnosis. The hallucinations experienced by patients vary greatly and can severely impact~     an individual's ability to function on a daily basis. In approximately 25-30% of these~     patients, medication is an ineffective mechanism for managing these symptoms. These~     hallucinations are known as medication refractory auditory hallucination (MRAH). For those~     whose auditory hallucinations do not respond to medication, non-surgical brain stimulation~     (NBS) has recently shown promise as a therapeutic intervention. Two specific types of NBS,~     called transcranial direct current stimulation (tDCS) and transcranial random noise~     stimulation (tRNS), seem particularly well suited to treating MRAH. They have yet to be~     compared to each other in large samples of patients with MRAH. The goal of the study is to~     investigate whether tRNS and tDCS are effective in the treatment of MRAH and if one is~     better than the other when compared directly.~   "
26082|NCT02715752|"~     This study measured the changes in health-related complaints by analyzing charts of~     individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.~   "
26083|NCT02715739|"~     This study aims to compare the predictive performance of two different approaches of the~     international classification of disease injury severity score (ICISS) using data from four~     public university hospitals in urban India.~   "
26084|NCT02715726|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in~     comparison to ezetimibe as add-on therapy to stable maximally tolerated daily statin therapy~     in high cardiovascular (CV) risk patients with hypercholesterolemia in Asia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on other lipid parameters: eg, Apolipoprotein~          (Apo) B, non-HDL-C, total cholesterol (TC), lipoprotein a (Lp[a]), high-density~          lipoprotein cholesterol (HDL-C), triglycerides (TG), and Apo A-1.~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics (PK) of alirocumab.~   "
26085|NCT02715713|"~     The primary goal of this pilot study is to investigate the association between testosterone~     deficiency and the presence of abnormalities in the function of the autonomic nervous~     system. If such association exists, then we will investigate the effect of testosterone~     replacement therapy on correcting these abnormalities.~   "
26086|NCT02715700|"~     This study will evaluate the effects of multiple doses of MK-1439 (doravirine) on the~     pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The~     primary hypothesis is that the Area Under the Concentration-Time curve to 24 hours (AUC0-24)~     of (R)-methadone is similar when a maintenance regimen of methadone is administered with or~     without multiple daily doses of MK-1439.~   "
26087|NCT02715687|"~     Post-operative atrial fibrillation (POAF) is the most common complication encountered after~     cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic~     use amiodarone was found to be effective, however, due to serious extracardiac adverse~     effects therapy is probably appropriate just for patients at high risk for POAF.~      the common practice for management of POAF is treatment with intravenous Amiodarone until~     return to sinus rhythm, following which the drug is given orally. Our protocol involves~     continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of~     200mg per day.~      This protocol is a common practice in many cardiac surgical departments worldwide,~     nevertheless, it is not evidence-based protocol and it was never examined as such.~      This study is a randomized placebo controlled trial, to evaluate the requirement for~     post-discharge treatment with oral Amiodarone.~   "
26088|NCT02715674|"~     This study will compare the effectiveness of postoperative incentive spirometry and~     noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients.~     Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a~     CPAP (continuous positive airway pressure) group (G-CPAP, n:20)~   "
26089|NCT02715661|"~     This project will examine the association between (cardio)vascular disease, blood supply to~     the brain, and cerebrovascular endothelial activation. Also, we will investigate the impact~     of exercise rehabilitation on brain vascularization, cerebrovascular endothelial function~     and blood flow control.~   "
26092|NCT02715622|"~     The objective of this prospective, multi-center post-market study is to prospectively~     collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or~     robotic assisted hernia repair.~      The outcomes that will be collected include various routine clinical parameters, short term~     patient reported outcomes (quality of life, pain scores) and long term hernia recurrence~     information. Patients will be treated according to standard of care at the surgeon's~     institution and patients will be followed up to collect information related to complications~     information and patient satisfaction associated with the hernia repair procedure.~   "
26093|NCT02715609|"~     The proposed study will be a multi-institutional, phase I/II study of disulfiram (DSF) for~     patients with presumed glioblastoma multiforme (GBM) based on magnetic resonance imaging~     (MRI) or biopsy, including administration before surgery and during adjuvant~     chemoradiotherapy. Patients will be treated with 3 days of preoperative DSF/copper (Cu)~     prior to their surgery (or biopsy), which will be followed by collection of blood and tumor~     samples during surgery for analysis of drug uptake. After the surgery, patients will receive~     standard radiation therapy (RT) and temozolomide (TMZ) with the addition of concurrent~     DSF/Cu.~   "
26094|NCT02715596|"~     This study is designed to evaluate the effect of EPA supplementation on muscle mass in~     patients with squamous cell carcinoma of the head and neck locally advanced (stage III-IVb)~     to assess that supplementation with EPA can maintain muscle mass along the oncologic~     treatment. Other aims are to evaluate the nutritional status, acute and chronic toxicities~     related with the loss of muscle mass and the impact of the EPA supplementation on overall~     and disease-free survival.~   "
26095|NCT02715583|"~     Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease~     planning to undergo Ra-223 therapy may be eligible for this study. Positron emission~     tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging~     will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care~     99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy~   "
26096|NCT02715570|"~     PC945 is a new medicine being developed for treatment of fungal lung diseases. The main~     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     single and repeat doses of PC945~   "
26097|NCT02715557|"~     In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of For Life~     (henceforth Arise), an innovative computer-based coping skills educational program for~     adolescent substance abuse treatment completers. For Phase I, 3C developed and tested two~     customizable intelligent educational modules to teach coping skills in order to help~     adolescents avoid relapse, along with a brief instructional game for each segment. The Phase~     I prototype for Arise also included an online Parent Guide to inform parents about the uses~     and benefits of the product. Phase I R&D provided strong support for the quality and value~     of the prototype as well as the viability of the proposed educational package and its~     promise for preventing substance abuse relapse with adolescents. Phase I results supported~     excellent quality of the product through high ratings of quality, appeal, and value. High~     feasibility and usability was also demonstrated through high ratings for ease of use,~     usability, and potential effectiveness.~      The goal of this Phase II SBIR project is to modify and expand the Arise program developed~     in Phase I in response to customer feedback and to evaluate the efficacy of the full program~     with an RCT pilot clinical study. This product will be an adaptable software program for~     aftercare therapy. In Phase II, the investigators will build on the Phase I findings to~     modify and extend the existing content and develop the full Arise program, which will~     include: an introductory module as well as interactive lessons and skill-building games for~     five coping skills modules. The Phase II product will also include a HelpCenter to support~     sustained, quality use of the product during commercialization.~   "
26098|NCT02715544|"~     Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less~     active than is recommended and are increasingly engaged in sedentary behaviour, which places~     them at risk of becoming overweight or obese. The proposed project will test whether~     connecting families to nature positively influences physical activity (that is, active~     playtime) and healthy eating routines in children aged 2 to 4. The investigators have~     recently conducted a pilot study Play & Grow (P&G), a programme based on the most successful~     international preschool interventions described in the literature. In addition to adopting~     healthy eating and physical activity intervention elements, the programme was enhanced by~     including a novel third element: connectedness to nature (CN). To test the effectiveness of~     this enhanced intervention, the plan is to run a family-based randomised controlled trial~     (RCT). The intervention will include 240 families with children aged 2 to 4, will take the~     form of one-hour activity sessions for parents and children held once a week for 10 weeks.~     The investigators will assess lifestyle-related habits before, immediately after the~     completion the intervention, at 6 months and one year after the intervention. Created for~     this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale~     (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are~     intended to be used to understand which components of the intervention were most effective.~     The objectives of this project will be achieved over a 36-month period, and it is expected~     to contribute to a close examination of key components of successful healthy lifestyle~     promotion programme during early childhood. The investigators predict that is that the new~     element CN will significantly improve the intervention. Finally, the overall aim is that~     connecting families to nature will result in sustainable lifestyle changes that remain with~     them for a lifetime.~   "
26099|NCT02715531|"~     This study will evaluate the safety, tolerability and pharmacokinetic variability of~     atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and~     5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU +~     cisplatin.~   "
26100|NCT02715518|"~     The aim of the study is to compare clinical outcomes following fractional flow reserve~     (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related~     artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with~     multivessel disease~      Prospective, open-label, randomized, multicenter trial to test the clinical outcomes~     following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in~     patients with acute AMI with multivessel disease.~   "
26101|NCT02715505|"~     This study is designed to assess the safety and exploratory efficacy of using HSC835 in~     patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.~   "
26111|NCT02715375|"~     This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter,~     double blind study with an allocation ratio of 1:1. The study population is children between~     the ages 6 to 17 years, with mild to moderate persistent allergic asthma. The purpose of the~     study is to determine whether the CREON2000A, an environmental control device, will decrease~     asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with~     mild to moderate persistent allergic asthma over a twelve month period.~   "
26102|NCT02715492|"~     Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are~     inoperable because of late presentation and underlying cirrhosis. It represents the fifth~     most common tumor in the world and the third most frequent cause of mortality amongst~     patients with cancer.~      Due to the worldwide difficulties in finding liver for transplantation, hepatic resection~     (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter~     arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable~     HCC or for patients not eligible to be operated on .~      TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which~     could prevent recurrence and improve long-term survival .~   "
26103|NCT02715479|"~     The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of~     Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176~   "
26104|NCT02715466|"~     This prospective, double-blind randomized controlled trial evaluates the differences in~     terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based~     resuscitation in two parallel groups of patients with severe sepsis / septic shock.~   "
26105|NCT02715453|"~     Frailty has been associated to a worse outcome in acute coronary syndromes, but the best~     management of frail patients after an acute coronary syndrome remains unknown. The aim was~     to investigate the benefit of an intervention on frailty in frail patients after an acute~     myocardial infarction.~      Patients survivors after an acute myocardial infarction (with and without ST-segment~     elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points)~     according to the Fried's scale measured 24 hours before hospital discharge, will be~     included. The participants will be randomized to 2 strategies: a) intervention on frailty in~     addition to the usual care by the cardiologist, and b) conventional strategy consisting only~     of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and~     physiotherapists and nutritionists) will carry out the intervention on frailty The study~     contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included~     patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year.~     The secondary endpoint will be the clinical events, both cardiovascular and not~     cardiovascular events, including recurrent events (cumulative events analysis), for the~     total follow up (3 years in the case of the first included patient). The hypothesis is that~     an intervention on frailty will improve frailty status and the clinical outcomes in frail~     patients after an acute myocardial infarction.~   "
26106|NCT02715440|"~     Intervention randomized controlled open study with 2 parallel arms . The objective of this~     study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly~     living in nursing homes.~      It will check that the judgment of these molecules has no pejorative effect on sleep or~     behavior of residents and does not induce withdrawal syndrome. Two patient groups will be~     constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other~     group will continue his treatment and withdrawal will be proposed after 8 weeks by his~     general practitioner (delayed intervention).~      Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The~     repercussions of withdrawal on behavior will be rated by the NPI scale.~   "
26107|NCT02715427|"~     Enhanced rehabilitation programs are based on new therapies and treatment combinations to~     reduce the length of hospitalization, duration of postoperative convalescence, morbidity,~     but also the overall cost of care. The operating stress and hypercatabolic conditions~     surrounding the surgery are sources of complications. In this enhanced rehabilitation~     approach, the principle is to fight through a series of actions against this surgical~     stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the~     feasibility and the interest of enhanced perioperative rehabilitation in liver surgery.~     Nevertheless, there is not until now French data concerning the assessment of enhanced~     rehabilitation in liver surgery. The main objective of the study is to compare the~     effectiveness of the implementation of a multimodal management program after liver surgery~     in a French university center compared to conventional care. Secondary objectives of the~     study are to compare an enhanced rehabilitation program in liver surgery versus conventional~     treatment in terms of morbidity and mortality in the immediate postoperative period and~     until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery.~     Compliance to the program in both groups will also be evaluated.~   "
26108|NCT02715414|"~     A multiple family group (MFG) is a family-centered, group delivered, evidence-informed,~     manualized intervention that targets the most common reason for referral to publicly funded~     clinics: youth oppositional defiant and conduct disorders. This study will employ a mixed~     methods Type II effectiveness-implementation hybrid research design.In collaboration with~     the NYS Office of Mental Health (OMH), this longitudinal study will be conducted across the~     NYC OMH licensed child behavioral health clinic system (n=134). The investigators will use~     mixed methods, and involve 268 providers and 2,688 adult caregivers of youth (7 to 11~     years).~      The following Specific Aims guide this study: To examine 1) short-term and longitudinal~     impact of MFGs on urban youth with ODD and CD (replication); 2) family-level mediators (e.g.~     parenting, family process) of child outcomes; 3) clinic (readiness to adopt an innovation,~     leadership support and climate) and provider level moderators (preparedness, motivation and~     fidelity) of MFG implementation and integration and; 4) the impact of CITs on clinic and~     provider level moderators of MFG implementation and integration. In this RCT, clinics will~     be stratified by borough (Manhattan, Queens, Bronx, Brooklyn, Staten Island) and randomly~     assigned within borough to 3 study conditions: 1) MFG+CITs; 2) MFG (with standard research~     training and consultation) or; 3) Standard Care. Data will be collected baseline, 8 and 16~     weeks and 6 mo. follow-up) in Phase 1 (focus on implementation) and Phase II (integration).~   "
26109|NCT02715401|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and~     co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers~   "
26110|NCT02715388|"~     Evaluate the use of Elbit's digital electro-optical systems for generating detailed high~     quality video imaging during surgery, and thus improving the surgeon's visualization,~     performance and outcome.~   "
26228|NCT02713854|"~     To determine the predictive value of attachment rate of human embryonic stem cells~     (hESC)-derived trophoblast spheroids (BAP-EB, embryo surrogate) onto endometrial epithelial~     cells (EEC) on success of IVF treatment and to use the model to identify EEC surface~     biomarkers for endometrial receptivity.~   "
26112|NCT02715362|"~     Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable~     choice. Because by intravenous infusion, T cells first entered into the blood circulation,~     but the number of T cells accumulated at the tumor site is limited, while the probability is~     high that CART cells contact with normal tissue where target protein is expressed, leading~     to a more potential off-target side effect. In this study, CART cells infused to the body is~     mediated by the method of transcatheter arterial infusion(TAI), which is one kind of tumor~     intervention therapy pathway. We hope by this means could improve the local CAR-T cell~     numbers，meanwhile reduce the potential side effects.~   "
26113|NCT02715349|"~     Families with a patient with schizophrenia and the patient are randomly assigned to receive~     either a 3 session psychoeducation program, or no psychoeducation. Other treatment for~     schizophrenia and other mental illness are provided as usual.~   "
26114|NCT02715336|"~     Individuals undergoing In Vitro Fertilization must undergo controlled ovarian~     hyperstimulation (COH) to produce enough quality eggs for fertility treatment. Ovarian~     follicular responsiveness to COH with gonadotropins is extremely variable between patients~     and even from cycle to cycle for the same patient. Achieving an ideal follicular response is~     critical to the success of assisted reproduction treatment (ART). Patients have been~     classified as 'poor', 'normal' or 'high' responders, which dictate the amount of~     gonadotropins that they receive. It is still important to develop treatments with high~     efficacy, lower multiple birth rates, and a lower complication rate for each of these~     groups. In an era of evidence-based medicine and with special emphasis on reducing IVF risks~     (mainly OHSS and pregnancies with multiples), it is very important to find optimal and safe~     ovulation induction and triggering regimens for each patient population.~      The use of GnRH agonist (GnRHa) triggering among high responders in order to reduce or~     eliminate OHSS is an example of an important breakthrough in the clinical management of IVF~     patients. Although GnRHa triggering was shown to be as effective as human chorionic~     gonadotropin (hCG) at inducing oocyte maturation more than 20 years ago, its use to trigger~     ovulation was not possible until the introduction of GnRH antagonists for pituitary~     suppression.~      Another prominent trend in ART in recent years has been the introduction of dual triggering,~     which involves a combination of GnRHa plus hCG for triggering. This regimen creates~     simultaneous lutenizing hormone (LH) and follicle stimulating hormone (FSH) surges by the~     GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like~     activity from the hCG, which stimulates the corpus luteum to excrete sufficient hormonal~     endometrial support. Since its introduction, dual triggering has been gaining popularity due~     to outstanding results in retrospective studies among both normal and high responders.~     Moreover, in spite of the encouraging retrospective reports, prospective randomized~     controlled trials (RCT) on dual triggering have not been reported to date. The aim of the~     current proposed study is to compare the efficacy of dual triggering and conventional~     triggering among the three IVF populations (high, normal and poor responders).~   "
26115|NCT02715323|"~     Ocular surface disease, especially dry eye and scleritis, commonly affects patients with~     autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease;~     however the full subset of immune cells activated is unknown. Recent experimental studies~     show that dendritic cells and T cells in the cornea are critically associated with corneal~     nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo~     imaging of dendritic cells and corneal nerves. The investigators propose to investigate how~     ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology~     interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis~     (RA), Systemic lupus erythematosus (SLE).~      The preliminary flow cytometric studies show that various immune cells (eg: T cells, B~     cells, and dendritic cells) can be quantified using minimally invasive impression membranes~     (Eyeprim). Clinically, the research team is experienced in measuring features of ocular~     surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M.~     The investigators also aim to harvest conjunctival immune cells using impression cytology~     and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic~     cell density and distribution will be assessed using CCM; in collaboration with the group~     who have pioneered this technique.~      The investigator anticipate that alterations in corneal nerve and dendritic cell parameters~     will correlate with immune activation/inflammation, deterioration of tear function and~     increased systemic severity of the rheumatological disease. In addition, the investigators~     hypothesize that the lower the corneal nerve density, the higher the number of corneal~     dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow~     a better mechanistic understanding of local corneal and systemic immune activation and the~     development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and~     nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new~     therapies in autoimmune patients with severe dry eye.~   "
26116|NCT02715310|"~     In order to estimate the effect of fluid management in regard to postoperative complications~     this observatory study will document every kind of fluid intervention peri- and~     intraoperatively.~   "
26117|NCT02715297|"~     This multi-center randomized controlled phase II trial will investigate the impact of~     stereotactic fractionated radiotherapy to the resection cavity of complete resected~     recurrent glioblastoma on progression free survival. As secondary endpoints, overall~     survival, safety and toxicity as well as early response criteria on MRI, quality of life and~     neurocognitive function will be assessed. Chemotherapy will not be part of the protocol,~     however, additional treatment will be possible upon investigators best choice.~   "
26118|NCT02715284|"~     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti~     programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid~     tumors who have limited available treatment options. The study will be conducted in 2 parts:~     dose escalation and cohort expansion.~   "
26119|NCT02715271|"~     The correlation of the morphologic, microbiological, genetic and histopathological~     characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and~     features of the patients will provide essential information~        1. on the role of the host in the mechanisms associated to the generation and evolution of~          active TB and~        2. about future diagnostic and/or prognostic biomarkers of TB disease. All this~          information could be used for patients stratification and/or to design new therapeutic~          strategies.~   "
26120|NCT02715258|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).~   "
26121|NCT02715245|"~     In this research, investigators pretent to evaluate the effectiveness of clinical,~     functional, psychological and social impact of an intervention model based on shared care~     between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers~     of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and~     their caregivers. A non-randomised controlled trial.~   "
26152|NCT02714842|"~     This is a single-centre, open-label, randomised, three-arm crossover study with a fourth~     fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the~     study. This study is designed to correlate the gastrointestinal transit behaviour of~     delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption~     profiles.~      The investigators will be looking at:~        1. The behaviour of the tablets (when, where and how quickly they break up)~        2. The gastric emptying time of the tablets (when they leave the stomach)~        3. The gastrointestinal transit of the tablets (how long they take to travel through the~          gut)~        4. Blood levels of the drug (diclofenac)~   "
26153|NCT02714829|"~     A Randomized, Subject-Assessor Blind, Multi-center, Clinical Study of Injectable Ceramics~     Bone Graft Substitute Containing rhBMP-2~   "
26122|NCT02715232|"~     Background Sex hormones such as estradiol and testosterone modulate human brain structure~     and function and are tightly connected to neuropsychiatric disorders such as depression and~     anxiety disorders. Using molecular imaging in humans in vivo, the investigators showed~     strong influences of sex hormones on serotonergic neurotransmission via modulation of~     serotonergic receptors and transporters. Although, animal studies also indicate strong~     modulatory influences on serotonin synthesis and degradation, human data on this potential~     effect are absent.~      Objectives of the study The aim of this study is to prove the modulatory influence of sex~     hormones on serotonergic neurotransmission by determining the enzymatic processes involved~     in serotonin synthesis and degradation using positron emission tomography (PET) in humans in~     vivo with the radiotracers [11C]AMT and [11C]harmine.~      Study design Single-blind, longitudinal study. Transsexuals will undergo four PET and two~     magnetic resonance imaging (MRI) measurements: 1. One [11C]AMT PET, one [11C]harmine PET and~     one MRI measurement before start of treatment, 2. One [11C]AMT PET, one [11C]harmine PET and~     one MRI measurement after 4 months of treatment. The investigators propose an overall study~     duration of 36 months.~      Materials and Methods:~      PET measurements will be performed on a GE Advance PET scanner. To examine the~     interdependence between serotonin activity and brain structure and function, four MRI~     sequences will be performed in order to assess gray matter volume and cortical thickness,~     gray and white matter microstructure, as well as resting state functional connectivity and~     cerebral blood flow. MRI measurements will be done on a 3 Tesla scanner with high spatial~     and temporal resolution.~      Study population 20 healthy female-to-male (FtM), 20 healthy male-to-female (MtF)~     transsexuals (aged 18-50) who are free of hormone-medication at baseline; 40 healthy~     controls, matched for sex, age and education level.~      Relevance and implications of the study This will be the first imaging study to investigate~     the effects of high-dose, long-term opposite-sex steroid hormones on serotonin synthesis and~     degradation in the living human brain using PET. The study will lead to the establishment of~     a comprehensive theory of serotonergic modulation by sex steroids and will increase~     knowledge on the serotonergic role in shaping brain morphology, microstructure and~     structural/functional connectivity. Results will provide essential data for a better~     understanding of neural sex differences associated with differences in hormonal states in~     humans and will elucidate neurobiological correlates of the known gender difference in the~     prevalence of neuropsychiatric disorders, thus contributing to the development of~     personalized treatment, the reduction of personal suffering and the reduction of costs and~     occupational disability.~   "
26123|NCT02715219|"~     Asthma is an important chronic disease that causes a significant public health problem and~     the commonest medical conditions treated in health clinics giving rise to considerable~     morbidity and mortality. Several studies suggested that improvement of patient knowledge has~     become a key component of asthma management. In the study setting the education material for~     Asthma patient is available however the proper cannel to deliver it to patient remains a~     puzzle to the researcher, therefore this study is trying to close the gap between Asthma~     education material and patient.The aim of the study is to investigate the effectiveness of~     an Asthma Education Program (AEP) result in improvement of patient's knowledge, medication~     adherence and inhaler technique.This is an experimental study a clinical trials. Data will~     be gathered utilising three an adapted instrument to assess patient knowledge of their~     disease, medication adherence and inhaler technique. Patients who are came to Asthma Bay in~     Emergency Department, Respiratory Clinic for routine follow up and admitted to ward will be~     recruited as study subjects. Subject who are agree to enrol in the study will be randomized~     into intervention and control group. Subjects in intervention group will be undergone one~     session of an AEP, however there are no intervention for control group but continue~     routinely follow up in Respiratory Clinic. To obtain the study result descriptive and~     inferential statistical analysis will be performed. To analyse the statistical significant~     of the change in patients' health outcome the pre and post of AEP independent t-test or~     chi-square test will be used.The expected finding of this study is to determine the~     effectiveness of AEP result in of patients' knowledge regarding asthma disease, medication~     adherence and inhaler technique, pre and post of AEP.~      Keywords: asthma, asthma education program.~   "
26124|NCT02715206|"~     The purpose of this study is to determine if a new substance use prevention curriculum for~     rural middle schools is effective in reducing substance use and to study how prevention~     curriculum get implemented by teachers.~   "
26125|NCT02715193|"~     This is a randomized, placebo-controlled, double-blind study to evaluate safety,~     tolerability and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are~     currently receiving insulin treatment. This proof of concept study will determine whether~     glucagon receptor blockade using a single dose REMD-477 can improve short-term glucose~     homeostasis in people with Type 1 diabetes.~   "
26126|NCT02715180|"~     The almost evidences of the optimal hand position during compression had been based on chest~     computed tomography (CT) or chest plain films of patients for investigating the effective~     location for compressing the left ventricle of the heart during cardiopulmonary~     resuscitation (CPR).~      However every study was conducted at full inspired state of respiration. A prospective~     cohort study to evaluate the proper hand position during CPR based on expired respiratory~     state CT as the health screening would be needed.~   "
26127|NCT02715167|"~     The hypothesis is that a high fractional exhaled nitric oxide can predict the response to~     inhaled corticoids in chronic cough.~   "
26128|NCT02715154|"~     Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact~     of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or~     analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and~     other psychological reactions in cesarean section. Although the placental transfer and the~     foetal metabolism of dexmedetomidine have been reported and the result show no adverse~     effects on neonates, but the placental transfer of dexmedetomidine in intravertebral~     anesthesia area was lack of systematical research. This study intends to use of~     dexmedetomidine in the cesarean section under epidural anesthesia and investigate its~     effects on the parturients' haemodynamics and the neonates' placental transfer and~     metabolism.~   "
26129|NCT02715141|"~     Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been~     implemented. Screening will increase the demand for surveillance. Although patients in whom~     adenomas have been removed are at increased risk of progressing to cancer, solid evidence on~     the reduction of death from CRC through the current colonoscopy-based surveillance is~     lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high~     individual burden and high costs. Therefore, there is need for new surveillance strategies.~     Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an~     immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve~     as an alternative for colonoscopy surveillance.~      The aim of this study is to compare the accuracy of an established molecular stool test~     (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced~     neoplasia) in a surveillance population. These outcomes will be used to model various~     strategies of stool-based molecular surveillance to inform health policy decisions.~   "
26166|NCT02714660|"~     This mixed methods study aims to answer the question: What is the work of being a patient~     with type 2 diabetes mellitus? .~   "
26167|NCT02714647|"~     The purpose of this study is to determine if priming attention prior to practicing a motor~     task will have an effect on the ability to acquire and learn that motor task. The~     investigators hypothesize that the acquisition and learning of a motor task will improve if~     attention is primed prior to practicing that motor task when compared to a group who does~     not receive the prime.~   "
26229|NCT02713841|"~     The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled~     insulin administration with 3 different inhalation regimens and with subcutaneous insulin~     administration.~   "
38622|NCT02551497|"~     This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the~     interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned~     to enrol 36 subjects.~   "
26130|NCT02715128|"~     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Among~     others, deficient cognitive control over emotional distraction is a central characteristic~     of MDD (Ochsner & Gross 2005; Disner et al. 2011; Beck 2008). Hypoactivation of the~     dorsolateral prefrontal cortex (DLPFC) has been linked with this deficit (Dolcos & McCarthy~     2006). Moreover, aberrant functional connectivity patterns have been found in MDD patients~     (Kaiser et al. 2015). Transcranial direct current stimulation (tDCS) is a non-invasive brain~     stimulation method that has been largely investigated in experimental neurosciences and tDCS~     of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. So far,~     prefrontal tDCS has been shown to enhance cognitive control over emotional distraction in~     MDD patients (Wokenstein & Plewnia 2013). Also, tDCS-induced connectivity changes found in~     fMRI studies comparing resting-state networks configurations before and after prefrontal~     tDCS may reflect a state of enhanced alertness (Keeser, Meindl, et al., 2011; Park et al.,~     2013).~      The aim of this study is to investigate the neurophysiological correlates of tDCS effects in~     MDD patients. For this purpose, functional magnetic resonance imaging (fMRI) data is~     collected during the execution of a cognitive control task as well as during a resting-state~     condition following real or sham tDCS. It is hypothesized that prefrontal tDCS as compared~     to sham a) reduces distractibility by compensating for deficient DLPFC activity and b)~     enhances functional connectivity in networks associated with externally directed attention~     or cognitive engagement.~      In this placebo-controlled study patients with a diagnosis of MDD receive a single treatment~     with prefrontal tDCS (anode over electrode position F3, cathode over F4, 20 min, 2mA~     intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp~     out periods only without intermittent stimulation). Before, during, and after the treatment~     resting-state measurements in the fMRI scanner are conducted. Subsequently, participants~     perform the cognitive control task (in dependence of Plewnia, C., Schroeder, P. A., &~     Wolkenstein, L. (2015)) in the scanner. The patients are assigned to either the real or sham~     tDCS condition according to a randomised, double-blind parallel design.~   "
26131|NCT02715115|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Rett syndrome in children and adolescents.~   "
26132|NCT02715102|"~     Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic~     surgery without a distant history of cancer will have their blood drawn for measurement of~     circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the~     early detection of lung cancer.~   "
26133|NCT02715089|"~     The purpose of this study is to explore the precise treatment in hepatobiliary cancer~     patients and evaluate drug safety, progression free and overall survival. This trial study~     is based on genetic tests, then therapeutic target drugs are administered according to the~     genetic test reports. Patients with genetic abnormalities (such as mutations,~     amplifications, or translocations) may benefit from precise treatment which targets~     particular genetic abnormality. The identifications of these genetic abnormalities may help~     treat hepatobiliary cancer patients better.~   "
26134|NCT02715076|"~     The purpose of this study is to determine:~        1. the effect of ambient temperature on the rate of core temperature change from 1 to 3~          hours after induction of anesthesia (linear phase of the hypothermia curve) in major~          operations lasting at least a couple of hours and~        2. whether the relationship between ambient temperature and rate of core temperature~          change is different for patients who are or are not warmed with forced-air.~   "
26135|NCT02715063|"~     Several studies have shown relationship between exercise intensity and improvement~     cardiometabolic health such as body composition, endothelial function, blood pressure and~     blood lipids. It has been suggested that high intensity interval training and also strength~     or resistance training generate positive effects on metabolic risk factors, nevertheless the~     comparison between both types of training and their combination has not yet provided~     conclusive evidence. Also, it has been shown that dietary restriction has similar or more~     positive effects that exercise alone and the effect is greater when it is combined with~     exercise. For these reasons, it is necessary to clarify which type of training, in~     combination with a dietary restriction, is more effective to improve cardiometabolic health~   "
26136|NCT02715050|"~     The effects of phototherapy has been widely studied by some research groups. The~     investigators know that there are positive results with light application to improve muscle~     performance and delay fatigue. However, there are few studies showing its´ effects on~     muscular training. Therefore, the aim of this study was to assess the effects of~     phototherapy applied at different times during 12 weeks of strength training. For such, 48~     volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength~     training protocol for the anterior muscle of the thigh development. Volunteers performed the~     training protocol three times a week for 12 weeks. There were assessed isometric peak torque~     in isokinetic dynamometer, concentric peak torque, 1-repetition maximum test in the leg~     extension and leg press machines and bilateral thigh perimetry.~   "
26137|NCT02715037|"~     Prospective, observational study of the microbiology of patients referred to a tertiary care~     center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.~   "
26138|NCT02715024|"~     The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin~     alone or in combination with solifenacin for the treatment in men with lower urinary tract~     symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.~   "
26139|NCT02715011|"~     The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2D) and schedule~     for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178~     at the RP2D(s) in Part 2.~   "
26140|NCT02714998|"~     The investigators aimed to investigate the effects of salpingectomy and Methotrexate~     administration on ovarian reserve in ectopic pregnancy.~   "
26141|NCT02714985|"~     Retrospective laboratory evaluation of the detection rate of CHIKV infection by real-time~     Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on urine. Urine and serum samples~     from patients with confirmed CHIKV infections from an endemic area (Aruba) and from ITM will~     be analyzed. The results will be evaluated on a case-by-case basis: time since onset,~     patient characteristics, severity of symptoms, serology results.~      The positivity in-time of CHIKV RNA in urine will be evaluated in comparison with viremia.~     Patients with suspected acute CHIKV infection will be asked (by written informed consent;~     annex 1) to provide urine samples within 72 hours after onset of disease, followed by urine~     samples on day 7, day 10, day 14 and three urine samples 3, 4 and 12 weeks after onset. They~     will be asked to provide serum samples within 72 hours after onset of disease, followed by~     serum samples on day 7, day 10, day 14. In total, twenty patients with an initial positive~     result of CHIKV RT-PCR on serum will be included for follow-up. The number of urine samples~     that will be tested is 140.~   "
26180|NCT02714478|"~     The purpose of the study is to evaluate the effect of Equistasi device on quantitative and~     qualitative gait characteristics in patients affected by hemiparesis.~   "
26142|NCT02714972|"~     Objective: to gain experience in children and younger adolescents with in-home use of an~     algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition~     to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility,~     safety, and initial efficacy data~      Study Design: randomized controlled trial, with randomization on a night level within~     subject Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with~     daily insulin therapy for at least one year and an insulin infusion pump for at least 6~     months who have HbA1c < 10.0%.~      Sample Size: 30 subjects~      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in~     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits~     at enrollment, following CGM and system assessment run-in phases, at start of clinical trial~     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use~      Major Efficacy Outcomes:~        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.~        -  Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in~          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.~      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood~     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and~     diabetic ketoacidosis~   "
26143|NCT02714959|"~     The purpose of this study is to determine whether low-dose IL-2 is effective in refractory~     autoimmune encephalitis.~   "
26144|NCT02714946|"~     The purpose of this study is to prospectively compare percutaneous radiofrequency ablation~     (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.~   "
26145|NCT02714933|"~     The aim of this study is to compare a new Magnetic Resonance Imaging (MRI)protocol,~     including a new MRI sequence for visualization of lung parenchyma, to computed tomography as~     the gold standard for the evaluation of thoracic region in children.~   "
26146|NCT02714920|"~     Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The~     therapeutic choice depends on the stage of the disease and the habits of the medical teams.~     Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the~     existing strategies has proven its superiority.~      Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the~     ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in~     non-tumor tissues can also explain the toxicity of cancer treatments.~      Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer~     a good strategy for identifying biomarkers or indicators of treatment response. This study~     will explore the capacity of a comprehensive functional approach that addresses several~     pathways, based on the use of three innovative patented technologies, to classify the tumor~     response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature.~      Our hypothesis is that taking into account various clinical parameters (e.g. patient and~     tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature~     would create patients' profiles and optimize their management.~   "
26147|NCT02714907|"~     The purpose of this study is to validate the quality of the ECG-signal acquired with the~     Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial~     fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring~     methods used in clinical practice.~   "
26148|NCT02714894|"~     The purpose of this study is to investigate the relationship between glutamate and related~     brain chemicals and treatment response to clozapine in patients with treatment-resistant~     schizophrenia.~   "
26149|NCT02714881|"~     The objective of this study is to elucidate the relationship between inflammation and~     lipoprotein atherogenicity, and to determine the relative contribution of inflammation and~     lipids to CV risk in RA. The central hypothesis of this study is that inflammation and~     lipoprotein atherogenicity is tightly linked such that both factors are important to assess~     CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by~     a consideration of routine lipids alone.~   "
26150|NCT02714868|"~     The purpose of this study is to determine the extent to which Project TEAM (Teens making~     Environment and Activity Modifications) is an effective, socially valid, and feasible~     intervention that prepares youth with developmental disabilities ages 14-21 to respond to~     environmental barriers and increases participation in school, work, and the community.~     Project TEAM is a manualized intervention co- facilitated by a disability advocate and a~     licensed professional. The intervention includes eight group sessions and two experiential~     learning field trips. In addition, young adults with disabilities serve as peer mentors on~     field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes~     are to: increase youths' knowledge of environmental factors and modification strategies;~     reduce the impact of environmental barriers on participation; increase self-efficacy and~     self-determination; and increase participation in a personal activity goal in the area of~     education, employment, or community life. This project builds on a participatory action~     research partnership with disability community stakeholders to address the following~     research questions: (1) To what extent do youth with disabilities participating in Project~     TEAM achieve intervention outcomes? (2) What are the characteristics of youth with~     disabilities who most benefit from Project TEAM? (3) To what extent are goals, procedures,~     and outcomes of Project TEAM important and acceptable (socially valid) to youth with~     disabilities?.~   "
26151|NCT02714855|"~     The present study will be conducted to assess the following research questions in real-life~     conditions in France:~      What are the patient and disease characteristics, comorbidities and treatment history in~     NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment~     currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive~     patient profiles different from one treatment pattern to another when initiating a new AC~     treatment?~      What are the HCP's reasons for discontinuing the previous AC strategy for initiating and~     choosing the newly initiated AC treatment in NVAF patients?~      What are the conditions of newly-initiated apixaban prescriptions in NVAF patients:~     prescriber, proportion of naïve/experienced patients, daily dosage and number of daily~     doses?~   "
26181|NCT02714465|"~     Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic~     resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife~     surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)~   "
26154|NCT02714816|"~     The inherited retinal dystrophies are a clinically and genetically heterogeneous group of~     conditions, which often present in childhood. These disorders can be usefully divided~     according to whether they (i) are stationary or progressive; and (ii) exhibit predominantly~     rod or cone involvement, or central receptor disease. The underlying molecular genetic basis~     of the majority of monogenic inherited retinal disease has now been characterised.~      Leber Congenital Amaurosis (LCA) is a diagnosis for a group of severe, autosomal recessively~     inherited rod - cone dystrophies that typically result in complete visual loss in the third~     or fourth decade of life. One form, LCA2, is caused by a mutation in the gene encoding~     RPE56, an RPE-specific 65-kDa isomerase. Non-functional RPE65 results in photoreceptor cells~     that are unable to respond to light resulting in these patients being visually impaired.~      Proof of principle studies for RPE65 gene replacement therapy has been demonstrated with the~     use of recombinant adeno-associated virus serotype 2 (rAAV2/2) vectors in animal models.~     Furthermore clinical trials of gene replacement therapy in RPE65 associated LCA (RPE65-LCA)~     have shown significant promise. All three clinical trials showed improvement in visual~     function over the first year, however longer term follow up demonstrated progressive visual~     loss and that initial improvements were not maintained.~      Greater efficacy was noted in animal models and we feel the relatively lower efficacy of~     treatment in participants was most likely due to insufficient production of RPE65 protein~     from AAV2/2 hRPE65 in the human eye. As the maximal tolerated vector dose had been reached~     for AAV2/2 hRPE65, an optimised therapeutic vector (AAV2/5-OPTIRPE65) has been developed to~     drive higher transgene expression levels. (Professor Robin Ali and Prof James Bainbridge -~     unpublished data).~      In preparation for human clinical trials, a detailed prospective phenotypic study will be~     undertaken to investigate the natural history of RPE65-LCA. Such a study will help identify~     suitable patients for therapeutic intervention. Furthermore through greater phenotyping an~     optimal window for intervention and specific parameters to help quantify effect and identify~     clinical end points may have been ascertained .~   "
26155|NCT02714803|"~     The aim of this study is to compare of different massage techniques plus conservative~     aplications in low back pain treatment.~   "
26156|NCT02714790|"~     Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as~     medullary expression of WT1 gene), performed at Baseline and during treatment according to~     clinical practice. MRD results will be relate to treatment outcome and survival analysis~     variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)~   "
26157|NCT02714777|"~     The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4~     to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic~     nervous system and their kinetics of early postoperative course (24 hours).~   "
26158|NCT02714764|"~     The purpose of this study is to define the natural history of Alexander Disease, a~     leukodystrophy that causes neurological dysfunction. Investigators will obtain clinical~     outcome assessments to measure how the disease affects a patient's gross motor, fine motor,~     speech and language function, swallowing, and quality of life. The data obtained from this~     study will be used for the design of future treatment trials.~   "
26159|NCT02714751|"~     Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can~     develop adverse effects. Patient-ventilator asynchronies can be present from the beginning~     of MV, it can be associated with poor outcome and it can develop clinical changes. The aim~     of this study is to evaluate if the knowledge of the presence of asynchronies by the~     healthcare team can help to reduce its incidence, improving outcomes of critically ill~     patients.~      A prospective, single-center, before and after study will be conducted in the ICU of~     Hospital de Sabadell. The study will have 2 phases: a first observational period where the~     incidence of asynchronies will be assessed, and a second period where a daily information of~     the presence of asynchronies to the healthcare team will be done with the aim to reduce the~     incidence.~      A continous record of asynchronies and clinical variables will be done during ICU stay.~   "
26160|NCT02714738|"~     The purpose of this study is to determine whether the incidence of tourniquet pain is~     decreased if infraclavicular nerve block is administered, compared to axillary brachial~     plexus block, for surgical interventions at the level or distal to the elbow.~   "
26161|NCT02714725|"~     This study is designed to explore the possible effects of dexmedetomidine infusion on~     sublingual microcirculation in patients undergoing on-pump coronary artery bypass graft~     surgery~   "
26162|NCT02714712|"~     The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins~     (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to~     examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which~     encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian~     chronic hepatitis C (CHC) patients.~   "
26163|NCT02714699|"~     The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac~     potassium on the pain scores during office hysteroscopy~   "
26164|NCT02714686|"~     In this experiment, the investigators will study the effect of a mass media family planning~     campaign on contraception related behavior. The study takes place in Burkina Faso, a country~     with an average of six children born to each woman, and a modern contraceptive prevalence~     rate (mCPR) estimated at 15% in 2010 at the national level, as per the Demographic Health~     Survey (DHS) 2010 report on Burkina Faso.~      The aim of this study is to provide robust evidence on the efficiency and cost-effectiveness~     of an intense three-year mass media campaign focused on family planning. The campaign will~     diffuse messages about the financial and health benefits of family planning, and information~     on the different types, sources, advantages, and disadvantages of different contraceptive~     methods. The study will target women at the age of reproduction in rural areas of Burkina~     Faso to measure the effect of the intervention on total and modern contraceptive prevalence~     rates, perceptions of family planning, contraception-related behavior, and general gender~     norms.~      Burkina Faso is an ideal place to evaluate the impact of a radio campaign because a high~     percentage of the rural population listens to local radio which is in the local language.~     Radio station areas are distinct because they target very local languages and their reach is~     limited by government decree, which allows for the implementation of a randomized control~     trial.~   "
26165|NCT02714673|"~     It is a multicenter, prospective, observational study of standard care. This study analyses~     the care of patients on long term effective anticoagulation therapy (ADELC) during a primary~     hip or knee arthroplasty.~      The objectives of the study are to:~        1. Identify clinical practices set up for patient care~        2. Assess the type and the frequency of perioperative complications~        3. Look for factors, related to patients or treatments, associated with the occurrence of~          these complications.~      The main objective is to estimate the risks, adjusted and not, of postoperative~     complications associated to a long term anticoagulation by comparing patients under~     anticoagulation to a control group of patients having the same interventions but who are not~     under anticoagulation.~   "
26168|NCT02714634|"~     Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent~     inflammatory arthritide, are non responders to the consensual 1st line of treatment :~     methotrexate. In these patients, it is well demonstrated that the addition of other~     immunomodulatory drug(s) often results in a significant improvement. However, the best~     option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to~     adding a targeted biologic therapy, such as anti-TNFα, and more recently abatacept or~     tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs),~     methotrexate+salazopyrine+hydroxychloroquine could be an alternative option to biologics,~     all the more as they have a more favorable safety profile and a much lower cost. Uncertainty~     remains regarding the superiority of biologics on triple therapy in methotrexate~     insufficient responders (IR). Investigators decided to address this issue by performing a~     randomized controlled pragmatic trial.~   "
26169|NCT02714621|"~     The primary objective of this pilot study is to determine whether or not it is feasible to~     use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an~     acceptable safety profile when conventional treatment options are not available. The~     ultimate goal is to be able not only to offer a viable method of symptom palliation in~     patients with recurrent pelvic tumours and improve their quality of life; but also to~     control tumour growth and extend life in a group of relatively young patients with isolated~     local recurrence.~   "
26170|NCT02714608|"~     Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is~     being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in~     patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency)~     and explore the optimal dosage~   "
26171|NCT02714595|"~     This study is designed to provide evidence of efficacy of S-649266 in the treatment of~     serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.~   "
26172|NCT02714582|"~     Hospitals face the challenge to continually improve their quality of care. In order to~     achieve this goal, they have to focus on both improving clinical practice and increasing the~     involvement of patients in the healthcare process. Both factors are equally important to~     quality of care. The World Health Organization highlights the role that patients and their~     family could play in the improvement of healthcare. Active patient participation reduces~     communication errors, increases patient empowerment and is associated with positive health~     and psychosocial outcomes. A possible strategy to improve patient participation through~     communication can be bedside shift report (BSR).~      Bedside shift report is a process where shift-to-shift report between nurses is, if approved~     by the patient, executed at the patient's bedside in order to improve the patient's~     involvement. Bedside shift report has the potential to result in more patient satisfaction,~     better clinical outcomes, improvement of health education and enhanced team coherence.~     Preliminary research indicates that BSR decreases safety incidents and adverse events and~     readmissions, positively influences staff satisfaction, offers beneficial financial effects~     by reducing nurses' overtime, and allows direct patient care to start earlier.~      Despite of these effects, rigorous and large-scale scientific research on this topic is~     lacking. Currently, the available evidence is scarce and mostly consists of single case or~     small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are~     also unknown or inconclusive. There is a need for an increased number of controlled studies~     to evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal~     results.~      The aim of this study is four-folded:~        1. The development and fine-tuning of a BSR-intervention and implementation protocol by~          using diagnostic interviews, co-design, and pilot studies.~        2. A quantitative evaluation of BSR in comparison with care as usual on patient-related,~          clinical, and nurse-related outcomes.~        3. A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR~          as a method to improve communication and patient participation with a particular~          interest in the experience of benefits and disadvantages by healthcare professionals~          and patients.~        4. A process evaluation of BSR to determine the intervention fidelity and to assess the~          evolution of BSR over the period of the study (e.g. adaptations, consistent practice).~      The study design was based on the Medical Research Council-framework for developing and~     evaluating complex interventions. Power calculation indicates a minimum of 5 experimental~     wards with 35 patients should be included in the study. The hospital, the specialization of~     the ward and the nurse-patient ratio will be used for the matched controlled assignment.~   "
26173|NCT02714569|"~     The purpose of this two-part study is to evaluate the safety and tolerability of the study~     drug known as LY3202328 in healthy overweight participants in Part A, and those with~     dyslipidemia (abnormal blood fats) in Part B.~   "
26174|NCT02714556|"~     Pregnancy is associated with physiological changes affecting the cardiorespiratory system as~     a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of~     this prospective observational study is to examine the perioperative changes in ventilation~     inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath~     washout and forced oscillation techniques.~   "
26175|NCT02714543|"~     Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is~     associated with both significant morbidity (including burning sensation and reduced oral~     opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has~     largely been symptomatic and is associated with high recurrence rate. Aloevera has~     immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic~     activities. All such properties of Aloevera suggest the possibility of its use in the~     management of oral submucous fibrosis.~      In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2~     groups (Group A & B). Group A patients were instructed to drink 30ml of aloe vera juice~     twice daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion~     3-4 times daily for 3 months. Group B patients were given intralesional injections of 1.5ml~     Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were~     also prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg,~     Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of~     the capsule) for 3 months. Patients were assessed for burning sensation, interincisal~     mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.~   "
26176|NCT02714530|"~     The purpose of this study is to determine if erlotinib given orally along with concurrent~     palliative irradiation to lung cancer improves local control compared to those treated with~     radiotherapy alone.~   "
26177|NCT02714517|"~     The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in~     patients affected by neuropathy.~   "
26178|NCT02714504|"~     Patients admitted for autologous or allogeneic hematopoietic cell transplantation,~     induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute~     lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be~     screened with dermatologic examination. In the presence of any skin lesion in the~     extremities, direct exam and fungal culture will be performed. If these exams indicate the~     presence of Fusarium species, patients will receive anti-mold azole prophylaxis~   "
26179|NCT02714491|"~     Aim of the study is to define if the auditory stimulation during stepping verticalization~     sessions with Erigo is able to modify the cerebral electric activity or improve~     consciousness in patients affected by vegetative state or minimally conscious state.~   "
26182|NCT02714452|"~     The overall aim of this study is to evaluate the effects, meaning and significance of a~     person-centred and thriving promoting model for residential aged care in Australia, Norway~     and Sweden. More specifically, the following research questions will be explored:~        1. Can a person-centred and thriving promoting care model increase residents' thriving,~          and have a positive impact on residents' perception of the caring environment?~        2. Can a person-centred and thriving promoting care model increase relatives' satisfaction~          with care, and have a positive impact on their experience of visiting their relative,~          and perception of the caring environment?~        3. Can a person-centred and thriving promoting care model increase staff's job~          satisfaction, decrease stress of conscience, and have a positive impact on their~          perception of the caring environment and person-centred care?~        4. What meaning and significance do relatives and staff ascribe to the intervention? The~          study is designed as a multi-centre, controlled group before-after design with~          participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden).~          Two residential aged care facilities at each site will be allocated to either~          intervention or control, in total three intervention and three control facilities~          divided over the three sites.~      Care staff at the intervention facilities will participate in a 12-month education on how to~     integrate aspects of person-centredness, thriving and a caring environment into daily care~     practice. Participating staff will work together with their colleagues and members from the~     research group to create a reflective and creative learning environment that builds on and~     develops the staff members' clinical experience and skills, and combines it with theoretical~     and research-based knowledge.~      At the control facilities, care staff will participate in a 2-hour lecture on the~     theoretical and philosophical foundations of person-centredness, thriving and a caring~     environment, and then continue with practice without further involvement from the research~     team.~      Evaluation data will be collected by study specific questionnaires before the education~     starts, immediately after the education and at a 6-month follow-up. In addition, focus group~     interviews and individual interviews will be conducted with a selection of staff members and~     relatives at the intervention facilities to explore meaning and significance of the~     intervention.~   "
26183|NCT02714439|"~     The purpose of this study is to evaluate a different type of medical equipment called~     High-Resolution Microendoscope for the diagnosis of cervical pre-cancerous lesions and~     cervical cancer. We want to compare the patients' clinical findings using the current~     equipment that we have in clinic with the clinical findings using the new equipment that we~     are testing on this research project. If the new equipment is proven to give comparable~     findings with the current equipment that we are using, doctors might be able to offer a~     diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for~     cervical biopsies to come back before women would receive the indicated treatment. Patient~     is being asked to participate because they have been diagnosed with an abnormal Papanicolaou~     (PAP) smear, and they need to have a colposcopic examination to determine the reason for~     their abnormal PAP smear and receive treatment.~   "
26184|NCT02714426|"~     Attentional control, or individuals' ability to choose which stimuli in the environment they~     attend to and which they ignore, declines with older age. Studies from the past two decades~     suggest that mindfulness meditative practice, such as a standardized mindfulness based~     stress reduction programs, may increase the efficiency of attention networks.To date, the~     majority of studies that have related mindfulness meditation practice to attentional control~     have been based on retrospective self-reported mindfulness or cross-sectional measurement in~     experienced meditators. More recent experimental studies using pre-post training designs~     have shown that meditation-naïve individuals can experience attentional improvement with~     mindfulness intervention. This study seeks to elucidate the time course and process by which~     such attentional improvements might be achieved.~      This research study investigates change in attentional control as participants progress~     through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific~     aims: 1) to determine the time course of change in attentional components such as cognitive~     control and sustained attention as a consequence of MIT; attention will be measured weekly~     for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent~     to which change in attentional performance is coupled/correlated with markers of emotion~     regulation, perceived mindfulness, and perceived mind wandering.~   "
26185|NCT02714413|"~     Individuals in the United States now consume a substantial proportion of their total energy~     as added sugars. The consumption of caloric sweeteners has been steadily increasing over the~     last four decades. The potential health consequences of this practice have been subject to~     considerable debate. In addition to weight gain, higher consumption of sugar-sweetened~     beverages is associated with development of metabolic syndrome and type 2 diabetes. These~     findings support the current dietary guidelines that encourage consumers to limit their~     intake of added sugars. There is a need for a sugar substitute that is safe, palatable and~     has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar~     is possibly D-allulose also referred to in the literature as D-psicose. The present proposal~     is to address the efficacy of D-allulose in reducing postprandial blood glucose level in a~     random sample of Caucasian and African American population. Specifically the effect of~     D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load~     will be studied.~   "
26186|NCT02714400|"~     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low~     arousal threshold may wake up too early during a respiratory event, before upper airway~     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the~     respiratory arousal threshold could potentially improve the quality of sleep and sleep~     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit~     some patients with OSA. The overall goal of this project is to determine the importance of~     the arousal threshold in OSA, determine which patients might benefit from a raised arousal~     threshold, and test this hypothesis by using pharmacological manipulation of the arousal~     threshold to achieve this goal.~   "
26187|NCT02714387|"~     The purpose of this observational epidemiological study is to investigate the management and~     the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be~     analysed to answer pre-defined scientific projects and to improve management of these~     conditions.~   "
26188|NCT02714374|"~     The purpose of this study is to evaluate the safety of the investigational product GL-ONC1~     in combination with eculizumab. GL-ONC1, a vaccinia virus, has been genetically modified for~     use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used~     successfully in the past as smallpox vaccine in millions of people worldwide. Eculizumab is~     a type of drug called a monoclonal antibody. This drug is designed to inhibit the activity~     of a protein called complement. Complement is part of the body's immune system that destroys~     and removes foreign particles. Evidence from laboratory tests suggest eculizumab may allow~     GL-ONC1 to stay in the body longer before being cleared by the immune system, which may help~     destroy more cancer cells.~   "
26203|NCT02714179|"~     The investigators designed a prospective randomized study to investigate the efficacy of~     intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores,~     patient satisfaction, total morphine consumption and the incidence of morphine‑related side~     effects in patients undergoing cesarean section.~   "
26204|NCT02714166|"~     To evaluate the human eye irritation potential of one test sunscreen formulation.~   "
26189|NCT02714361|"~     Iron is one of the most vital elements in humans as it plays a role in physiological~     functions such as transferring and storing oxygen, transporting electrons and catalysing~     numerous reactions, from oxidative metabolism to cellular proliferation. Iron deficiency can~     be attributed to poor absorption that leads to insufficient iron to meet body requirements.~     Oral iron supplements have been extensively used to treat iron deficiency and iron~     deficiency anaemia. However, the use of iron compounds in fortifying foods is one of the~     best practical approach to combat iron deficiency, while improving diet and food pattern~     involves long-term goal which can be challenging. Vitamin D has recently been shown to~     affect hepcidin levels, which in turn has effects on iron status but there are a limited~     number of studies investigating the hepcidin profile in humans following iron~     supplementation, and few data are available, especially in humans, despite its role as a~     primary iron absorption and homeostasis regulator. Although several studies have been~     carried out using iron fortified products, there is limited data on the potential effect of~     vitamin D on iron metabolism amongst iron deficient women in particular. Therefore, the~     present study aims to investigate the effect of vitamin D3 supplementation (1500 IU)~     consumed with iron fortified breakfast cereals on haematological indicators and hepcidin~     response in iron deficient women.~   "
26190|NCT02714348|"~     Helminth infection is associated with low vaccine immunogenicity. Pregnant women are~     particularly sensitive to helminth infection.~      Since most vaccines are given shortly after birth, an effect of parasites on infant~     immunogenicity is of particular concern. Therefore, within this study the investigators aim~     to investigate if maternal infection influences vaccine immunogenicity in the newborn.~   "
26191|NCT02714335|"~     Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian~     especially Southeast Asian, it would be great interests to investigate the potential~     polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile,~     it is also interesting to study the expression of Preferentially Expressed Antigen In~     Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to~     find out significant factors which may affect their expression such as smoking status,~     histological types, tumour size and stages in Taiwan.~   "
26192|NCT02714322|"~     To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with~     moderate-to-severe chronic plaque psoriasis~   "
26193|NCT02714309|"~     Consuming whey protein may have beneficial effects on health, principally by having an~     impact on blood glucose metabolism, but also by affecting appetite. The purpose of this~     project is to investigate the effect of consuming whey protein preload prior to breakfast,~     following a bout of low/moderate intensity exercise (brisk walking), on glucose and lipids~     in the blood as well as on appetite.~      It is hypothesised that the consumption of whey protein before a meal after prior~     low/moderate intensity exercise may positively affect postprandial handling as well as~     appetite sensations and consequently reduce intake at a subsequent meal.~   "
26194|NCT02714296|"~     This study is an open, prospective, comparative diagnostic studies aimed at improving the~     colonoscopy results, by optimizing the way of preparation for endoscopy~   "
26195|NCT02714283|"~     The purpose of this study is to provide patients and their physicians with greater~     understanding of the risks and benefits of commonly used therapies for treatment of non-CF~     bronchiectasis~   "
26196|NCT02714270|"~     Paperless partograph is a technique used for monitoring the progress of labor before~     delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.~      The study will be carried out to find out the effectiveness of paperless partograph in~     management of labor and its effect on maternal and neonatal outcomes~   "
26197|NCT02714257|"~     The investigators propose a 36-month multi-center randomized effectiveness trial to compare~     the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching~     (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients~     with a previous fragility fracture (FF).~      The investigators will also examine the impact of the intervention on several secondary~     outcomes like: loneliness, physical function, and bone strength. The investigators will do~     this by following a Pragmatic trial design: 1) limiting exclusions to increase~     representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting~     measures to those practicable for use in usual care.~   "
26198|NCT02714244|"~     Diastolic function may be evaluated by different measurements on transesophageal~     echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave~     doppler (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral~     annulus velocities, early diastolic (e') and late diastolic (a') are obtained by tissue~     doppler imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as~     such, might be a predictor of fluid responsiveness.~      The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for~     fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid~     responsiveness being defined as an increase in stroke volume of ≥ 15%.~      After induction of anesthesia, patients will have their diastolic function evaluated by~     means of E/e' and other measures. They will then be administered an intravenous bolus of 500~     mL of Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid~     responsiveness will be assessed by the thermodilution method (Swan-Ganz catheter) and the~     FloTrac® device. Fluid responders will be compared to non-responders to evaluate the~     relationship between E/e' ratio and fluid responsiveness.~   "
26199|NCT02714231|"~     The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus~     oral hyoscine butyl bromide versus cervical lidocaine-prilocaine cream during intrauterine~     device insertion.~   "
26200|NCT02714218|"~     The purpose of this study is to evaluate two different dose combinations of nivolumab and~     ipilimumab in the treatment of melanoma.~   "
26201|NCT02714205|"~     A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate~     therapy in 140 peri- or postmenopausal women who have frequent hot flashes. Women will be~     randomly assigned to uninterrupted use of transdermal nitrate therapy (participant directed~     dose-escalation of 0.2 to 0.6 mg/hr) or identical-appearing placebo patches for 12 weeks.~   "
26202|NCT02714192|"~     The purpose of the study was to determine if administration of an exercise stress test~     within the first ten days after a sports related concussion would delay or otherwise~     interfere with recovery.~   "
26206|NCT02714140|"~     Despite worldwide efforts to promote HIV Counseling and Testing (HCT), rates of testing~     remain low. Understanding how high risk groups decide to test and adapting available testing~     options to their preferences has the potential to broadly improve HCT uptake and~     cost-effectiveness. This study proposes to use a Discrete Choice Experiment, a survey method~     increasingly used by health economists for the design of patient-centered health care~     options, to rigorously quantify HIV testing preferences among two high-risk populations,~     identify their preferred testing options, and evaluate, in a pragmatic randomized controlled~     trial (RCT), the effect of a preference-based HIV counseling and testing (PB-HCT)~     intervention on testing uptake. At a time of heightened focus on health preferences research~     and patient-centered care, this study evaluates the critical link between preference-based~     intervention design and efficacy. If the RCT indicates that PB-HCT increases testing rates,~     the testing options evaluated in this R01 can be offered to high-risk populations in the~     study area, and the preference elicitation method and tools can be used to inform the design~     of testing options that better match the preferences of other high-risk populations and in~     other settings.~   "
26207|NCT02714127|"~     The aim of the study is to develop robust analytical protocols for first-void urine sample~     preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for~     improved diagnosis of cervical (pre)cancer lesions.~   "
26208|NCT02714114|"~     The aim of the study is to develop robust analytical protocols for first-void urine sample~     preparation and antibody assays to monitor natural and/or vaccine induced immunity against~     HPV (Human Papillomavirus).~   "
26209|NCT02714101|"~     Children with Autism Spectrum Disorder have difficulty engaging in activities. This study~     examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4~     to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline~     assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.~   "
26210|NCT02714088|"~     High-intensity interval training (HIT) has been demonstrated to be an effective strategy to~     improve markers of health and fitness across a wide range of healthy and clinical~     populations. Currently however, there is only limited evidence which has examined the~     effectiveness of HIT in older adults (>50 years). HIT is an appealing strategy in this group~     as it has the potential to impact both cardiorespiratory and muscular fitness, which both~     play an important role in maintaining functional fitness and quality of life in a~     time-efficient manner. Developing an understanding of novel strategies for delivering this~     type of exercise training may ultimately provide a viable alternative to traditional modes~     of exercise training for a broader range of participants. As such, the purpose of this study~     is to evaluate the effects of a novel, high-intensity interval training exercise protocol to~     improve physical fitness in adults aged over 50 years. This research also aims to evaluate~     if this type of training intervention is feasible in this population, through analysis of~     adherence and intervention fidelity.~   "
26211|NCT02714075|"~     Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability~     in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium~     ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent~     findings from single meal studies indicate CA/TSC to have an enhancing effect on iron~     absorption from FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental~     effects. Furthermore, in vitro findings suggest an increased iron solubility from iron and~     EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These~     effects should thus be investigated in 'real-life' conditions, when fortified rice is~     implemented in a complete diet administered throughout several days in a target population~     for a rice fortification program.~      Objective: To assess iron absorption from the diet from different iron fortified rice~     formulations in iron deficient anaemic children.~      The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children~     investigating different fortification approaches in a multiple meal randomized, cross over~     study.~   "
26212|NCT02714062|"~     The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521~     in obese adolescents.~   "
26213|NCT02714049|"~     Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study~     medication alone vs. study medication and sex therapy for 12 additional weeks.~   "
26214|NCT02714036|"~     This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be~     eligible subjects must meet the El Escorial criteria of possible, laboratory-supported~     probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability,~     blood, neuro-imaging biomarkers, and clinical outcomes will be collected on all subjects.~     Subjects will receive study drug for 36 weeks.~      The study will consist of a Screening Phase (up to 6 weeks), an Open-Label Treatment Phase~     (36 weeks) and a Off-Treatment Follow-up Phase (4 Weeks).~      Number of Subjects (Planned):~      Approximately 35 subjects are planned to be screened with the goal of enrolling 25 subjects.~   "
26215|NCT02714023|"~     Patients who are diagnosed with acute appendicitis consented and then randomized into two~     arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery~     with normal saline, or salt water. In the other arm, patients receive irrigation of the~     abdomen during surgery with sterile water. Sometimes patients receive no irrigation if none~     is determined to be needed at the time of operation by the surgeon. We then followed~     patients after surgery for 30 days. The hypothesis of this study was that the use of sterile~     water as irrigation fluid during surgery in patients who have acute appendicitis will~     decrease the chance of a post-operative abscess or infection.~   "
26216|NCT02714010|"~     This is a multi-center phase III randomized controlled study, designing to access whether~     the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung~     cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole~     brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary~     outcomes included overall survival (OS), objective response rate (ORR), evaluation of~     cognitive function, quality of life (QoL) and adverse events.~   "
26261|NCT02713425|"~     This research study aims to test the feasibility and effectiveness of using an entertaining~     video game as an addition to traditional therapy for the treatment of anxiety disorders in~     youth, particularly those youth who may have limited access to mental health treatment in~     the traditional clinical setting.~   "
26217|NCT02713997|"~     Patients with severe chronic pancreatitis may be candidates to have their pancreas removed~     and their islets transplanted into the liver to reduce the risk of diabetes mellitus, a~     procedure called total pancreatectomy with islet autotransplant (TPIAT). However, over half~     of patients who have a TPIAT will need to remain on some supplemental insulin life-long~     after the procedure. We will study therapies that may reduce damage to transplanted islets,~     and thereby improve long-term outcomes.~      Two promising anti-inflammatory therapies are available to protect islets from damage at the~     time of transplant: (1) the Tumor Necrosis Factor (TNF)-alpha inhibitor etanercept and (2)~     the serine protease inhibitor alpha-1 antitrypsin. Both agents are commercially available~     for clinical trials. Proof-of-principle for etanercept has been demonstrated in type 1~     diabetic allotransplant recipients, in whom a 10 day course of etanercept early~     post-transplant significantly improved long-term insulin independence, due to better~     survival of the transplanted beta cell mass in the engraftment period. Alpha-1 antitrypsin~     (A1AT) reduces inflammatory cytokines, protects against cytokine-induced beta cell~     apoptosis, and prolongs islet graft survival in mice and intraportal IAT non-human primates.~      This initial 3-arm drug-treatment clinical trial will investigate the use of Etanercept and~     A1AT to improve IAT function at 90 days and 1 and 2 years post-TPIAT compared to standard~     care. Forty-five patients undergoing TPIAT will be randomized 1:1:1 to receive either: 1)~     etanercept (50 mg on day 0; 25 mg on days 3, 7, 10, 14, and 21), 2) alpha-1 antitrypsin (90~     mg/kg IV days -1, +3, 7, 14, 21, 28) or 3) standard care. Patients will have mechanistic~     assessments drawn in the early post-operative period including inflammatory cytokines and~     chemokines and measures of beta cell loss. Metabolic testing will occur at 90, 365, and 730~     days post-TPIAT, including mixed meal tolerance testing, IV glucose tolerance testing, and~     glucose-potentiated arginine-induced insulin secretion (GPAIS).~   "
26218|NCT02713984|"~     Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid~     tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers.~     Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency~     targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its~     adverse effects including cytokine storm response and any other adverse effects. In~     addition, CAR-T cells persistence, tumor elimination and disease status after treatment will~     be evaluated.~   "
26219|NCT02713971|"~     Background: In this study, a new biofeedback system for balance and gait rehabilitation~     (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with~     real-time visual and acoustic feedback about their movement during functional tasks. Gamepad~     was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial~     to investigate its feasibility and efficacy versus conventional physiotherapy. The~     investigators hypothesized that Gamepad system can be easily applied in clinical settings~     and that biofeedback training with Gamepad provides larger improvements of balance and gait~     in PD subjects, respect to conventional physiotherapy.~      Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45~     minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group~     (biofeedback rehabilitation with Gamepad system), and Control Group (conventional~     physiotherapy). Clinical and instrumental assessments were performed by a blind examiner~     pre-, post-intervention and at 1-month follow-up.~   "
26220|NCT02713958|"~     This experimental research aims to examine the efficacy of Telerehabilitation treatment~     using a computerized system (MediTouch) in improving the upper limb function post elbow~     fractures. 24 participants aged 18-80 who are post surgery to fixate elbow fractures or~     arthrolysis of the elbow will be invited to participate in the study. The subjects will be~     matched into two groups according to age and fracture type to study and control groups. Both~     groups will be treated for a month in ambulatory clinic in the hospital and will do~     self-practice at home according to a intervention protocol. The subjects in the experimental~     group will receive two treatments in Telerehabilitation and one treatment in the clinic~     weekly, and the subjects in the control group will receive three treatments in the clinic~     every week. Activity daily living (ADL), Range of Motion, Hand strength disability and pain~     will be assessed before and after the intervention in order to asse the efficacy of the~     intervention.~   "
26221|NCT02713945|"~     This study evaluate the efficacy of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA)~     reductase inhibitors, also known as statins in the treatment of growth and skeletal~     abnormalities in children with Noonan syndrome. Half of patients will receive simvastatin~     while the other half will receive a placebo.~   "
26222|NCT02713932|"~     The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a~     prospective Italian registry including several centers performing TAVI, collecting baseline,~     procedural and outcome data.~   "
26223|NCT02713919|"~     Background: Up to 64% of cancer patients experience pain, and as many as 40% of patients~     with pain do not receive adequate pain management. And while potential to reduce pain has~     been shown in several interventions that support patients' self-management, effects have~     been moderate. Purpose: This multicenter mixed methods study primarily aims to evaluate the~     efficacy of the adapted German PRO-SELF© Plus Pain Control Program (PCP) on pain intensity,~     to explore the intervention's effect on associated symptoms and other patient and family~     caregiver (FC) outcomes, and to explore patients' and FCs' experiences with cancer pain~     management.~      Methods: A nested concurrent mixed methods design will be used for this multi-center study,~     that is, a randomized controlled trial (RCT) will be combined with a qualitative substudy.~     Participants will be randomly assigned to a 6-week intervention or usual care group;~     outcomes will be evaluated at 6 weeks post-randomization. The primary outcome will be pain~     intensity. A total sample of 210 patients with cancer pain and approximately 105 FCs will be~     recruited from the oncology outpatient clinics of the University Hospitals Basel, Zurich and~     Bern. The intervention is designed to implement structured and tailored components~     (information, skill-building, nurse coaching) and aims at improving patients' pain~     self-management. Data analysis will follow an intent-to-treat strategy and generalized mixed~     models will be used. For the qualitative substudy, 60 patients and FCs of both groups will~     be interviewed. Data will be systematically summarized.~   "
26224|NCT02713906|"~     The purpose of this study is to assess the positioning of customized guides designed from~     patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total~     knee arthroplasty.~   "
26225|NCT02713893|"~     The primary objective of the study is to evaluate local tolerability of the new~     Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone~     products and placebo. Pharmacokinetics of the study products after single and repeated~     applications once a day for 15 days, safety of the investigational products and comfort of~     use will also be evaluated as secondary objectives.~   "
26226|NCT02713880|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Transthyretin-Related Familial Amyloidotic Polyneuropathy from plasma. Testing for clinical~     robustness, specificity and long-term stability of the biomarker.~   "
26230|NCT02713828|"~     Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the~     lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab~     vedotin.~      Glembatumumab vedotin consists of an antibody (a type of human protein) attached to a drug~     called Monomethyl Auristatin E (MMAE) that can kill cancer cells. Glembatumumab vedotin is~     intended to work by specifically directing the drug to the cancer cell. It attaches to a~     molecule on the cancer cell called gpNMB, and then releases the MMAE inside the tumor cell,~     which in turn causes the cell to die.~      The purpose of this study is to see whether glembatumumab vedotin is effective in treating~     people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to~     examine how the body handles the drug and the side effects associated with glembatumumab~     vedotin.~   "
26231|NCT02713815|"~     The motivational-cognitive psychotherapy and repetitive transcranial magnetic stimulation~     (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.~   "
26232|NCT02713802|"~     Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single~     doses of Cudafol(R) and Diprivan(R) in healthy subjects.~   "
26233|NCT02713789|"~     To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg~     and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction~     longer than six months that is attributable to an underlying, stable medical condition.~   "
26234|NCT02713776|"~     During rectal or complex digestive surgery with multiple digestive resections and~     anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated~     that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year~     with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not~     controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients~     to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte~     abnormalities and acute renal failure. This risk implies parenteral correction which may~     extend hospital stay and delay home return.~      Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive~     secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not~     routinely used for the treatment of patients with high-output enterostomy and their efficacy~     in the indication (off-label) was only tested in small case series. Pasireotide (SOM230,~     SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for~     whom surgery is not an option or for whom surgery has failed.~      As the efficacity of pasireotide in patients with high-output enterostomy refractory to~     usual medical treatment associated with an oral fluid restriction has never been~     demonstrated before, there is a need to perform a pilot, double-blind, randomized,~     placebo-controlled trial evaluating its impact on reduction of the effluent volume.~   "
26235|NCT02713763|"~     The therapeutic goals in the management of pancreatic neuroendocrine tumors (pNET) are the~     control of symptoms and tumor growth control in order to improve patient survival.~      In recent years, data from two phase III studies with targeted therapies, sunitinib and~     everolimus, have broadened the possibilities for treatment of patients with neuroendocrine~     tumors of the pancreas.~      Unfortunately, patients progress and development of new active drugs and evaluating the best~     treatment approach is decisive.~      Given the lack of data comparing the activity of different treatment strategies, final~     decisions are based on medical experience and consensus of experts. In this context,~     different questions are still unanswered, as which is the best sequence of treatment and if~     all patients can benefit from all available drugs.~      Neuroendocrine pancreatic tumors are highly vascularized tumors in which cells may be~     dependent on this pathway for growth throughout the entire history of the tumor and in which~     inhibition of this pathway is crucial. On the other hand, this aspect has not been endorsed~     by the population of patients with pNET who have previously failed treatment with sunitinib.~      In this scenario we will assess retreatment with sunitinib to evaluate the activity of this~     drug in the context of therapeutic rescue in patients with metastatic pNET.~   "
26236|NCT02713750|"~     This study will create a model of reproductive health services for HIV-positive female~     adolescents in Asia.~   "
26237|NCT02713737|"~     The investigators hypothesized that heated humidified high-flow nasal cannula oxygen(HFNC)~     along with high quality of sleep, in comparison with noninvasive positive pressure~     ventilation (NIV), could reduce the release of inflammatory marker C-reactive protein(CRP),~     which as independent predictor of atrial fibrillation（AF）, further lower the incidence of~     new-onset AF following coronary artery bypass grafting(CABG).~   "
26238|NCT02713724|"~     This study investigates whether an individualized exercise program, including a personal~     trainer, can improve cardiovascular status quantified with ultrasound to assess coronary~     flow reserve and other non-invasive techniques. The subjects in the study will be divided~     into two groups; one group will have a personalized exercise- and nutrition program and the~     other group will have acess to a gym membership, but no personal trainer.~   "
26239|NCT02713711|"~     The purpose of this study is to compare the effectiveness of artificial balneotherapy (AB),~     phototherapy (PT) and artificial balneophototherapy (BPT) in the treatment of plaque~     psoriasis, evaluating the plaque area, alteration of skin pigmentation, Psoriasis Area and~     Severity Index (PASI) score determination and quality-of-life assessment by Short Form 36~     Health Survey (SF-36) and Psoriasis Disability Index (PDI) scores during the month of~     treatment. Methods: Experimental study, prospective, randomized, single-blind. 14 subjects~     participated from the city of Talca, Chile medically diagnosed with psoriasis, more than one~     plaque in the skin without topical treatment voluntarily. All subjects completed the study~     that consisted of 12 sessions.~   "
26240|NCT02713698|"~     The main purpose of this research is to develop a population pharmacokinetic and~     pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia,~     using BIS as a pharmacodynamic endpoint.~      A covariate analysis will be performed in order to account for variability in~     pharmacokinetic and pharmacodynamic parameters. The influence of age and obesity on propofol~     pharmacokinetic parameters will be particularly addressed.~   "
26271|NCT02713295|"~     This study estimates the treatment goal achievement rate, depicts the implementation of the~     Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and~     transitioning, and assesses patient adherence and persistence with adalimumab therapy in the~     routine clinical practice in Greece.~   "
26241|NCT02713685|"~     60 ASA grades- I, II or III patients, undergoing lower limb surgeries, will be randomly~     allocated in 2 groups of 30 patients each. In group S- subarachnoid block with 0.5%~     Bupivacaine (hyperbaric) 2.5ml will be given in lateral position and group B received~     femoral 3 in 1 block in supine position(with landmark technique) with 20 ml of 0.25% of~     Bupivacaine, followed by Sciatic block in lateral position with 20 ml of 0.25% Bupivacaine.~     Onset and duration of sensory and motor block, time of first analgesic requirement, VAS~     Scores at end of block and surgery, hemodynamic effects, patients' and surgeon's~     satisfaction will be evaluated.~   "
26242|NCT02713672|"~     The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19~     polymorphisms are specifically related to the metabolism of psychiatric drugs. The~     prevalence of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the~     number of functional alleles, individuals are classified as Poor Metabolizer (PM),~     Intermediate Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).~      Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced~     side-effects. Besides susceptibility for side effects and lower quality of life, also, a~     relationship between phenotype and costs of care has been shown.~      Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the~     effectiveness of the drug and/or to reduce side effects. No research has been done to~     investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric~     practice.~      This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping~     in psychiatric patients in Curacao and analyzes the costs of genotyping versus health~     benefits.~   "
26243|NCT02713659|"~     This study is testing the effects of early literacy promotion compared to standard literacy~     promotion at The Children's Hospital of Philadelphia. Eligible participants and their~     families will be consented and randomly assigned into either a standard literacy program or~     an early literacy program. Standard literacy will consist of the receipt of books and~     reading promotion beginning at 6 months of age, while early literacy will consist of the~     receipt of books and reading promotion beginning in the newborn period. In both groups,~     participants will receive weekly text messages until the child is 6 months old (the text~     messages will either about reading or safety) and have follow-up study visits at 6, 12, 18,~     and 24 months. The study will examine the effects of the intervention on language~     development and reading behaviors.~   "
26244|NCT02713646|"~     Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular~     compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due~     to lack of stereoscopic vision, this traditional method sometimes can not meet the~     requirement on identifying the existence and details of NVC, especially when the aberrant~     vessels turn out to be delicate veins. The three dimensional analytic techniques, such as~     curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be~     helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo~     and dynamic views, so as to assist to design the surgical plan.~      Furthermore, the frequent ﬁnding of NVC on MRI studies of asymptomatic patients incited the~     creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross~     perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the~     root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve~     may correlate with the severity of facial pain due to atrophy of the nerve in most cases of~     ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss,~     demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and~     volume (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be~     a useful biomarker for predicting the degree of ITN.~   "
26245|NCT02713633|"~     This prospective study, Randomized Trial of Indwelling Double-J Ureteral Stent Versus~     Externalized Modified-Salle Stent for Pyeloplasty will consist of four steps: 1.) Enrolling~     subjects in the study and signing the consent form 2.) Randomly divide subjects into 2~     groups, group 1 will have internal stent and group 2 will have external stent 3.) At the~     time of stent removal in the clinic or in the OR subjects parents/ subjects will fill a~     questionnaire about pain after the procedure, stent care and stent tolerance and 4) Data~     from the questionnaires and procedure cost will be collected and all the data will be~     analyzed~   "
26246|NCT02713620|"~     This is a follow up study from the published article entitled Comparison of immunogenicity~     and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination~     in HIV-infected adults: a randomized, controlled trial by Chaiklang K, Wipasa J, Chaiwarith~     R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov~     12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov;~     NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using~     either four standard doses or four double doses compared with the current standard regimen~     of three doses in HIV-infected adults in northern Thailand. In addition, the investigators~     evaluated the efficacy of the HBV vaccination with the current standard regimen of three~     doses between healthy adults and HIV-infected patients.~   "
26247|NCT02713607|"~     Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will~     look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.~      Investigators will look at the changes between acne subjects and control participants, but~     also the changes that occur after the use of antibiotics and how this is altered.~   "
26248|NCT02713594|"~     The study is designed to test the hypotheses that financial incentives can increase both~     participation in smoking cessation treatment and resulting cessation rates, when they are~     offered to BadgerCare Plus (Medicaid) smokers as part of their health care.~   "
26249|NCT02713581|"~     The primary objective of this study is to search for, in vitro, elements associated with~     IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant~     and pro-inflammatory factors) and to describe their prevalence in female patients with a~     history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary~     embolism) compared to control women.~   "
26272|NCT02713282|"~     The purpose of this study is to estimate the proportion of participants fulfilling criteria~     for symptomatic remission following a transition to 12 months treatment with flexible-dose~     paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia~     previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at~     least 4 months.~   "
26250|NCT02713568|"~     Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to~     term. However, clear identification of 'at risk' foetuses is difficult and clinical~     estimates of fetal weight are poor. Historically, ultrasound has been used as a second line~     in such cases but the accuracy of this imaging modality in the mid- to late third trimester~     is also limited.~      Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to~     guide obstetric interventions, when a fetus is small or large for dates. It frequently is~     the single most important component guiding interventions, such as induction of labour or~     Caesarean section.~      Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected~     macrosomia in the 3rd trimester, the investigators believe that these estimates should not~     be used to make important obstetric decisions regarding mode and timing of delivery and that~     a more accurate method of assessment could produce better outcomes by restricting~     interventions to those foetuses at greatest risk. Some publications have already~     demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more~     accurate than ultrasound~      The goal of the present study is thus to compare the performance of magentic resonance~     imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the~     prediction of neonatal macrosomia.~   "
26251|NCT02713555|"~     Roux-en-Y Gastric Bypass surgery (RYGB) ameliorates type 2 diabetes within days after~     surgery. Studies indicate that the gastric sleeve procedure has comparable effect on type 2~     diabetes, but to what extent and how is not fully elucidated. This study investigates the~     effect of the surgeries on incretin levels, glucose effectiveness and hepatic insulin~     sensitivity.~   "
26252|NCT02713542|"~     This study is primarily investigating the effectiveness of Autologous Conditioned Plasma~     (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.~   "
26253|NCT02713529|"~     A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in~     subjects with select advanced solid tumors.~   "
26254|NCT02713516|"~     Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for~     anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality~     exposures and to make therapy more available and accessible for patients with anxiety~     disorders. The societal benefit of increased access to therapy is that, if successful, it~     will increase the number of patients who receive appropriate treatment for an anxiety~     disorder.~   "
26255|NCT02713503|"~     The purpose of this study is to evaluate a variety of technologies in a driving simulator.~     Specifically, this research will provide a direct comparison of driver performance measures~     under various modes of mobile device interaction.~   "
26256|NCT02713490|"~     This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately~     300 adult subjects undergoing primary unilateral TKA under spinal anesthesia with~     bupivacaine HCl (10-15 mg).~   "
26257|NCT02713477|"~     Primary Objective:~      To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide~     fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes~     mellitus (T2DM).~      Secondary Objectives:~        -  To assess the pharmacokinetics (PK) of lixisenatide following administration of 2~          different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese~          patients with T2DM.~        -  To assess the postprandial glucodynamic response to insulin glargine/lixisenatide~          fixed-ratio combination compared to insulin glargine alone in Japanese patients with~          T2DM.~        -  To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio~          combination in Japanese patients with T2DM.~   "
26258|NCT02713464|"~     This study examines (a) whether introduction of public, health provider, and maternal~     education about risks of jaundice will decrease the occurrence of ABE compared with baseline~     prevalence (before-after design) or (b) whether antenatal or postpartum instruction to~     mothers will decrease the incidence of ABE compared with those who did not received~     instruction (concurrent opportunistic controls in phase 2).~   "
26259|NCT02713451|"~     No clear recommendation exists for the level of oxygenation of intensive care patients. In~     Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between~     88 and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These~     recommendations are common but do not lie on high scientific knowledge and level of proof.~     In the major studies of these fifteen last years that changed ARDS management, PaO2 was kept~     around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.~      Many recent review and cohort studies pointed the risk of excessive oxygenation especially~     following cardiac arrest, stroke or traumatic brain injury. However, these data come in~     majority from cohort or database study without strong definition of hyperoxia. Data coming~     from prospective studies are scarce and tend to show better outcome of patients with lower~     objectives of oxygenation in ICU.~      High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance~     injuries due to mechanical ventilation. O2 could be responsable of  hyperoxia induced lung~     injury .~      The investigators showed in a precedent study that comparing a restrictive oxygenation~     versus a liberal oxygenation was feasable and do not expose patients to major adverse~     events. More, mortality at 60 days has tendency to be lower. The investigators therefore ask~     if a lower objectives of PaO2 in comparison with the level usually seen in last studies on~     ARDS could improve ARDS patients outcome.~      The aim of this study is to show that a restrictive oxygenation in comparison with a liberal~     oxygenation strategy in patients with ARDS would lower mortality at 28 days.~   "
26260|NCT02713438|"~     AIMS: The project aims at investigating of the effects of three types of planning~     (individual planning, collaborative planning, and dyadic planning) on physical activity.The~     influence of three planning interventions are compared with an active control condition,~     including physical activity education.~      PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14)~     dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200~     dyads). The interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
26262|NCT02713412|"~     To determine whether the changes in blood pressure (BP) which occur following meals in~     normal people and patients who have substantial falls in BP after a meal postprandial~     hypotension (PPH)) are associated with changes in cardiac function. Eligible subjects who~     have been previously diagnosed with PPH will report to the Queen Elizabeth Hospital, on two~     occasions, following an overnight fast. Subjects will be cannulated and have a BP cuff~     placed around their upper arm. Following this, subjects will ingest either a drink~     containing 75 grams of glucose and 150mg of a C13 Acetate (which is metabolised and excreted~     in the breath, enabling noninvasive measurements of gastric emptying), made up to 300mL~     water, or on the other study day, 300mL water alone. The order of the study days will be~     randomised. Following the drink, for 3 hours, measurements will be taken at regular~     intervals of BP, heart rate, breath samples (on the study day with the Acetate only), blood~     samples (for measurement of blood glucose and gut hormones) and transthoracic~     echocardiography (TTE) (for assessment of end systolic and diastolic cardiac volume, cardiac~     output, cardiac contractility and diastolic function). After the 3 hours of measurements,~     the cannula will be removed and subjects will be offered lunch prior to leaving the~     department. Following lunch, on one study day, subjects will have their autonomic nerve~     function tested noninvasively, using an ECG.~   "
26263|NCT02713399|"~     A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia,~     astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately,~     cannot be prevented. There are different tools to correct them, like spectacles, contact~     lenses, and refractive surgery. Many different contact lenses are available, the two large~     groups create rigid contact lenses and soft contact lenses. It is a common knowledge that~     the presence of a contact lens in the eye divides the tear film into the prelens and~     postlens tear film layers. In the present study we want to investigate the variability and~     reproducibility of prelens and postlens tear film thickness measurements.~   "
26264|NCT02713386|"~     This phase I/II partially randomized trial studies the side effects and the best dose of~     ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how~     well they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or~     primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better~     treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.~   "
26265|NCT02713373|"~     This phase I/II trial studies the side effects and best dose of cetuximab when given~     together with pembrolizumab in treating patients with colorectal cancer that has spread from~     the primary site (place where it started) to other places in the body (metastatic) or that~     cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab,~     may block tumor growth in different ways by targeting certain cells.~   "
26266|NCT02713360|"~     The hypothesis is that there is a significant difference in anxiety scores between~     intervention and usual care group after intervention.~      The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and~     (ii) to investigate the effect of screening followed by randomisation to intervention with~     consultations based on cognitive therapeutic principals to reduce anxiety in patients with~     ICD or usual care.~   "
26267|NCT02713347|"~     Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) are common~     serious illnesses. Despite disease-specific medical care for CHF and COPD, people with~     either illness are often left with poor quality of life (i.e., burdensome symptoms, impaired~     function). Furthermore, while CHF and COPD are leading causes of hospitalization and~     mortality, few people with either illness engage in advance care planning, the process of~     considering and communicating healthcare values and goals. The investigators are conducting~     a randomized clinical trial to study a symptom management, psychosocial care and advance~     care planning intervention to improve quality of life. The study is important because it~     aims to improve quality of life and provision of care according to peoples' goals and~     preferences in common, burdensome illnesses. Furthermore, this study will generate~     information that supports the broader dissemination and implementation of the intervention~     and informs the development of future palliative care and team-based interventions in the~     VA.~   "
26268|NCT02713334|"~     The objective of this protocol is to characterize advanced cancer patients' responses to~     learning their secondary findings arising from tumor genomic profiling, and the process and~     outcomes of their decisions to communicate these results to their families.~   "
26269|NCT02713321|"~     Type 2 diabetes is common in the United States; about 1 in 10 people have the disease.~     Diabetes can cause devastating health events, such as hospitalizations, kidney failure,~     blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death.~     There are many barriers for patients with diabetes that get in the way of controlling risk~     factors, following recommendations, and getting the care they need from the health system to~     help prevent these complications; this is especially true for those with other health~     problems too. Those living in poverty and racial/ethnic minorities are more likely to have~     complications from diabetes, and less likely to get recommended care from health systems. In~     order to improve care and outcomes for people with complex medical problems, several states~     have started the Medicaid Health Home (HH) program, including New York State (NYS) in 2012.~     This program is for people with two or more chronic health conditions, such as diabetes and~     heart disease, people with HIV, and people with a serious mental health condition. HHs are~     meant to manage and coordinate care, by helping health care providers, social service~     agencies, community-based organizations, and health insurance plans work together. Similar~     programs have been shown, on a smaller scale, to improve some results for patients with~     diabetes, such as lab tests indicating level of diabetes control. Studies have not yet~     looked at how a large program like HHs impacts the way healthcare is delivered and impacts~     the health events that matter most to patients with diabetes. Also, few studies include~     stakeholders on the research team, even though they stand to benefit the most from such~     programs, and have the experience needed as patients, clinicians, advocates, and~     administrators to guide efforts. The investigators have gathered a research team that~     includes scientific investigators along with a diverse group of partners, including~     patients, clinicians, and program administrators. The investigators plan to use two data~     sources that show what happens to individual patients over time: 1) NYS Medicaid insurance~     data 2) the New York City-Clinical Data Research Network (NYC-CDRN). The NYC-CDRN has~     identified a group of patients with diabetes from 7 large health systems; it has also~     developed a system for putting together the same set of information for each patient, and~     removing any identifying information. The investigator will look at patients who have~     diabetes and are part of a HH and study what happened to them over time. The investigator~     will also look at a comparison group of patients who are very similar to the HH patients,~     but they did not join a HH, and follow them over time. The investigator will then compare~     these two groups to each other. The investigator will look at the quality of healthcare they~     received and their health outcomes. The investigator will focus on health outcomes that are~     meaningful to patients. This study can provide important knowledge about the effects of the~     HH program on patients with diabetes.~   "
26270|NCT02713308|"~     Observational, retrospective and perspective study with acute and chronic endpoints~   "
26273|NCT02713269|"~     The goal of this clinical research study is to find out if combining thermal ablation (using~     a laser to heat tumor tissue in order to shrink the tumor size) and spine stereotactic~     radiosurgery (SSRS--a method for giving radiation) can help control cancer that has spread~     to the spine.~   "
26274|NCT02713256|"~     An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks~     treatment in patients with Graves' disease~   "
26275|NCT02713243|"~     The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid~     diarrhea and to assess its safety and tolerability profile in patients with primary bile~     acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this~     indication.~   "
26276|NCT02713230|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in~     approximately 120 adult subjects undergoing primary unilateral total shoulder arthroplasty~     or rotator cuff repair with general anesthesia~   "
26277|NCT02713217|"~     Integrating mental health treatments into the primary care delivered at Community Based~     Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major~     priority for the Department of Veterans Affairs. However, there is no scientific evidence~     that integrating mental health and primary care is clinically effective at smaller CBOCs~     that have limited mental health staffing. The goal of this proposed project is to implement~     a blended combination of integrated care models that have been adapted for smaller CBOCs~     using telemedicine technologies, and evaluate the acceptability and effectiveness of the~     blended, telemedicine-based, integrated care model. If clinical outcomes are improved~     compared to usual care, findings will be used to justify and facilitate the implementation~     of this telemedicine-based integrated care model at smaller CBOCs in order to increase rural~     Veterans' access to effective mental health treatments.~   "
26278|NCT02713204|"~     The primary objective of the study is to compare the efficacy of intravitreal~     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).~   "
26279|NCT02713191|"~     The randomized controlled trial will compare efficacy and safety of dexmedetomidine to~     midazolam for sedation during endobronchial ultrasound~   "
26280|NCT02713178|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in~     approximately 300 adult subjects undergoing primary unilateral TKA under general or spinal~     anesthesia.~   "
26281|NCT02713165|"~     Raisins contain a significant amount of dietary fiber and polyphenolic compounds that~     represent an important substrate for microbiota fermentation which generates potentially~     beneficial end products, such as short-chain fatty acids. The mammalian gut contains a~     phylogenetically as well as functionally diverse microbiota that contributes to host~     physiology. To date, little is known about how increased raisin intake affects human gut~     microbiota composition.~      This research study will assess the effects of adding raisins to the diet of healthy adults~     on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well~     as markers of immune function. The hypothesis is that by adding raisins to the diet this~     will result in changes in gut microbiota. Furthermore, the changes in microbiota will~     largely be beneficial, as evaluated by an increase in butyrate producers and bacteria~     associated with anti-inflammatory properties.~   "
26282|NCT02713152|"~     This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and~     Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher~     in patients with OAG in comparison to people without glaucoma and if OSA is an independent~     risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that~     may be associated with both OSA and OAG.~   "
26283|NCT02713139|"~     The purpose of this study is to determine the efficacy and safety of the association~     clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when~     compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g~     (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different~     etiologies.~   "
26284|NCT02713126|"~     Participants with heart failure with preserved ejection fraction will undergo 12 weeks of~     cardiac rehabilitation for exercise training (ET) and be randomized to either nebulized~     sodium nitrite inhalation solution or placebo inhalation solution (normal saline) through~     the training period. Study drug is administered 3 times daily during daytime hours with one~     of these doses being immediately prior to onset of ET sessions throughout the 12 week trial.~     The objective is to determine if the inhaled sodium nitrite improves the clinical responses~     and tolerability of ET.~   "
26285|NCT02713113|"~     the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2,~     and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in~     laparoscopic bariatric surgery.~   "
26286|NCT02713100|"~     In recent years, there has been an emphasis on assessing patient's pain on presentation to~     emergency departments. The Joint Commission mandates that all patients who present with pain~     must have a pain assessment performed and addressed early in their care. Most emergency~     departments are using a self-reported assessment of pain using a 1-10 scale of pain. This~     self-reported level of pain is used to determining appropriate treatment. The Joint~     Commission has only dealt with somatic pain and has not addressed psychological related~     pain.~      Many authors have written on psychological pain. It is described as introspective experience~     of negative emotions such as anger, despair, fear, grief, shame, guilt, hopelessness,~     loneliness and loss. The assessment of psychological pain has been used to describe patients~     with depression and suicidal thoughts and behaviors.~      Study Significance The significance of this study is to determine if patients can~     communicate the level of psychological pain using the level of agitation as a surrogate~     marker. Studies have demonstrated that the staff's assessment of a patient's level of~     agitation is not based on an agitation scale nor uses any patient self-assessment of their~     level of agitation. If a self-assessment of a patient's level of agitation can be determined~     early in their care in the emergency setting, a proactive approach to treatment can occur.~     Proactive agitation treatment has the potential of reducing a patient's agitation and~     increasing their level of comfort. This early intervention can reduce the progression of~     agitation and the risk of injury to patients, families and staff.~      Hypothesis The study null hypothesis is that the self-rated agitation scale will not have a~     significant level of correlation with the other measures of agitation (Brief Agitation~     Measure, Positive And Negative Syndrome Scale and Agitation Calmness Evaluation Scale). The~     secondary null hypothesis is that there is no difference between the level of agitation and~     the level of psychological pain, assessed with the Psychological Pain Assessment.~   "
26295|NCT02712983|"~     The purpose of this study is to support the selection of a safe and tolerable tobramycin~     inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P.~     aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa~     colonization.~   "
26296|NCT02712970|"~     A staging system was defined based on morphological extent of disease (stage I to stage IV~     for primary disease, and stage R for recurrent disease). Specific surgical technique was~     used for each stage. Demographics, perioperative data, short-term and long-term outcomes~     were evaluated according to the disease stage.~   "
26287|NCT02713087|"~     Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in~     Anesthetized Patients with Cerebral Tumors~      Sponsor-investigator: Klaus Ulrik Koch M.D.~      Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus~     C, Denmark~      Objective:~      To investigate whether phenylephrine and ephedrine causes different alterations in~     microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients~     with brain tumors. Using MRI and PET, the study will assess whether there is a difference in~     deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral~     metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine~      Method:~      Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are~     infused intravenously under general anesthesia. MRI is performed in 20 patients before and~     after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS~     monitoring will be used in either scanner. After scanning patients are transported to the~     operating theatre and the craniotomy is performed. After removal of the bone flap subdural~     ICP is measured and recorded.~      MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after~     ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and~     phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and~     hemoglobin concentration is measured.~      Data from the proposed studies will add substantial new knowledge to the investigators~     current understanding of the effects of vasopressors on cerebral circulation. This~     information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the~     choice of the optimal method to manage cerebral perfusion pressure during craniotomy for~     brain tumor.~   "
26288|NCT02713074|"~     The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning~     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike~     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.~   "
26289|NCT02713061|"~     This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22~     days in healthy Japanese adults.~   "
26290|NCT02713048|"~     Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms~     myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its~     dynamics and diagnostic value is often controversial and has not been well described. Most~     of prior studies were retrospective, using first generation troponin assays and assessing~     only admission troponin. The aim of this work is to correlate dynamics of sensitive troponin~     I with urgent coronary angiography.~      Patients resuscitated after OHCA will be prospectively divided in three groups based on the~     results of their urgent angiographies. Serial assessment of sensitive troponin I will be~     obtained over initial 48 hours.~      We expect admission troponin will not be predictive of AMI. Over next hours troponin levels~     will be highest in patients with acute coronary lesion, lower in stable obstructive coronary~     disease and insignificant in non-obstructive coronary disease. We also expect significant~     difference in highest values and dynamics of troponin in sub-group with spontaneous~     reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0~     and 1). In patients with non-obstructive disease we expect troponin levels to correlate with~     duration of cardiac arrest, number of external electric shocks and cumulative dose of~     adrenaline administered.~   "
26291|NCT02713035|"~     Patients with atopic dermatitis and eczema often struggle with habitual scratching that is~     not well-controlled even with optimal medical therapy. Our goal is to create a behavioral~     intervention to help children with eczema reduce scratching. The investigators hope that the~     intervention will improve clinical outcomes and quality of life, as well as provide an~     easily implemented way for clinicians to educate patients and parents about behavioral~     modification techniques.~   "
26292|NCT02713022|"~     The investigators want to find a better way to predict the risk of having fatty tissue~     inflammation by using a different approach to finding out body fat composition. In this~     study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA~     stands for dual energy X-ray absorptiometry. It is the standard and established test to~     determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This~     test can also be used to determine the body composition including percent body fat and lean~     mass. The investigators will compare the participants DEXA scan results for body fat~     composition to the inflammation found in the breast tissue from the mastectomy to see if~     there is a relationship. If successful, this may help us predict which patients may be at~     risk for breast cancer in the future. In addition, the investigators will compare the~     participants DEXA scan results for body fat composition and inflammation found in the fat~     tissue from the mastectomy or prostatectomy to the level of exercise activity as measured by~     a short questionnaire to see if there is a relationship. The investigators will also measure~     the participants waist to hip ratio.~      Finally, at the time the participant has blood drawn for their standard presurgical testing,~     the investigators will also test the blood for prediabetes using a blood test called~     hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio,~     and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible,~     Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may~     help us predict which patients may be at risk for breast cancer in the future.~   "
26293|NCT02713009|"~     Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland.~     Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin~     and therefore may be hidden within the adipose/fat tissue in overweight/obese individuals.~     All pregnant and breastfeeding women are advised to take a daily supplement containing 10μg~     vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower~     vitamin D status than their leaner counterparts at the start of pregnancy and may need a~     higher daily supplementation to achieve a sufficient status.~      The investigators propose a randomised supplementation study where pregnant women (n 240)~     from the Western Health and Social Care Trust Area will be invited to take part.~      Inclusion criteria: pregnant women first trimester, without current pregnancy related~     complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².~      Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg~     vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin~     already contains 10μg vitamin D; Therefore participants will be randomised to receive a~     total of 10μg or 20μg vitamin D.~      Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will~     be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All~     blood samples will be analysed for vitamin D and other associated metabolites. Data will be~     collected on health and lifestyle, supplementation use and food intake. Body composition~     measurements will be recorded at each appointment and infant anthropometric measurements~     will be taken from the maternal notes after delivery. Findings from this research will be~     used to inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy~     which may be dependent upon pre pregnancy BMI.~   "
26294|NCT02712996|"~     The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can~     help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse~     is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact~     effects this drug may have on adults with attention deficits caused by TBI have been~     investigated prior. The exact effects this drug may have on children with attention deficits~     caused by TBI are not known, but the investigators expect that Vyvanse will be of some help~     in treating this population as well.~   "
26297|NCT02712957|"~     The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in~     patients with pain associated with osteoarthritis of the knee.~   "
26298|NCT02712944|"~     The purpose of this trial is to evaluate the effect of testosterone replacement in men with~     renal failure (on dialysis) who also have low testosterone. Specifically, the investigators~     will assess the change in requirement of Erythropoietin Stimulating agents.~   "
26299|NCT02712918|"~     The purpose of the current study was to examine Brief Behavioral Activation Treatment for~     Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly~     depressed inpatients. The study is a systematic replication of a randomized controlled trail~     from 2003, that provided initial support for BATD With inpatients. The current study~     compared BATD to Treatment as Usual in a randomized controlled trial.~   "
26300|NCT02712905|"~     This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with~     advanced malignancies. The study will be conducted in 2 parts. Part 1 (dose escalation) will~     determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum~     tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion)~     will further determine the safety, tolerability, efficacy, PK, and PD of the selected~     dose(s).~   "
26301|NCT02712892|"~     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of~     the general population. The devastating complication of IA is its rupture, resulting in~     subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there~     are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of~     an IA in a given individual. Also, there is no pharmacological drug available to prevent the~     rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive~     with a significant risk of procedural morbidity. Thus, still now, the management of patients~     with IA remains extremely challenging and still controversial. Although the pathogenesis of~     IA has been the subject of many studies for the last decade, the mechanisms underlying IA~     formation, growth and rupture are still mostly unknown and relevant animal models of IA are~     not available. Familial history of IA predisposes to IA formation and rupture and increasing~     evidence suggest a genetic component of IA formation, with heterogeneous modes of~     inheritance and penetrance. This project, gathering neuroradiologists, geneticists and~     vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA~     to develop diagnostic and predictive tools of risk of IA. The investigators propose to~     identify IA-causing variants by whole-exome sequencing in familial forms of the disease. The~     investigators hypothesises that the functional analysis of the causal/susceptibility~     variants thus identified will provide clues to understanding the pathological mechanisms of~     IA formation, and the bases for developing diagnostic tools. This project aims at meeting~     this challenge. Based on preliminary data that already allowed to identify such a variant,~     and the combination of genetic and functional investigations, the specific objectives of~     this project are: - To identify IA-causing variants in familial forms of the disease by~     whole-exome sequencing; - To understand the function of these genes/variants in the~     formation and rupture of IA by molecular and cellular approaches and generation of relevant~     animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.~   "
26302|NCT02712879|"~     Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the~     drainage system to define moderate bleeding postoperative cardiac surgery and define the~     population.~   "
26303|NCT02712866|"~     Background: Infiltration of GI by T lymphocytes is a pathogenic mechanism both in ulcerative~     colitis (UC) and in Crohn's disease (CD). Vedolizumab (VDZ) is a humanized monoclonal~     antibody binding with high affinity to α4β7 integrin blocking α4β7+-MAdCAM-1 interaction,~     hence blocking a key step in GI lymphocytes T infiltration. VDZ has demonstrated a~     therapeutic effect in UC and CD. Investigators still lack of adequate biomarkers to predict~     clinical response to biological treatments, specially avoiding invasive procedures.~      Objective: Study whether circulating CD4+ and CD8+ α4β7+ memory T lymphocytes and some of~     their surface markers might be molecular markers of response to VDZ treatment in patients~     with UC and CD.~      Methods: Prospective (pilot) study including 24 adult IBD patients (12 UC patients and 12 CD~     patients (patients with fistulizing perianal disease will be excluded) with active disease~     and prior failure to anti-TNFα treatments starting treatment with VDZ. They will received~     VDZ in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg~     intravenously, every 8 weeks).~      Epidemiological and clinical data from every patient will be recorded prospectively. Disease~     activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores,~     biological parameters and fecal biomarkers.~      At week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.~      Peripheral blood will be obtained from every patient at baseline, before the third infusion~     of VDZ (6th week) and before the first maintenance dose (14th week).~      Blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored~     circulating memory T cells.~      Percentage and absolute values of circulating CD4+ and CD8+ α4β7+ memory T lymphocytes as~     well as several surface markers related to their activation state (HLA-DR, CD25), Th17~     phenotype (IL23R, CCR6, intracellular IL17A) and Th1 phenotype (INFγ)will be assessed on~     α4β7+ memory T cells.~   "
26304|NCT02712853|"~     The goal of this project is to identify specific miRNAs that are increased or decreased in~     the saliva of children with developmental delay and are useful for screening toddlers for~     ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals~     to developmental specialists, and expedite the arrangement of early intervention services.~   "
26305|NCT02712840|"~     The purpose of this study is to determine whether the chances of becoming pregnant are~     better when day the single best day 5 embryo (blastocyst) resulting from an in vitro~     fertilization (IVF) cycle is transferred into the uterus immediately, or after freezing the~     embryo and transferring it into the uterus in a subsequent cycle, separate from the ovarian~     stimulation used in the IVF cycle. The investigators hypothesize that in good-prognosis~     patients, vitrified-warmed elective single embryo transfer will result in higher~     implantation, clinical and on-going pregnancy and live birth rates than fresh elective~     single embryo transfer at the blastocyst stage.~   "
26306|NCT02712827|"~     The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet~     the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair,~     surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal~     hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to~     tissue, as a result no fixation is required after placement. There are few data about~     Progrip in laparoscopic hernia repair. In this randomized controlled trial we would like to~     compare the use of Progrip with the conventional mesh in laparoscopic hernia repair.~     Surgery is performed in the usual manner; prior to placement of mesh, surgeon will get the~     randomization result for that particular patient: Progrip and non-Progrip group. No fixation~     is required for Progrip group, while fixation with fibrin glue is needed for non-Progrip~     group. Intraoperative data (e.g. mesh deployment time, operative time, etc) will be~     collected. Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year~     interval after surgery. Additional visits may be arranged if considered necessary. At follow~     up patient will be seen by surgeon first to review the wound condition and to look for any~     recurrence; while other post-operative data including total analgesic usage (number of~     tablets), return to normal activities (days), return to work (days), pain score etc will be~     assessed and recorded by a trained nurse who is blinded to the treatment that patient~     received. Any hernia recurrence will be recorded and treated accordingly. Primary aim of~     this study is to look for any difference of the 2 groups in terms of postoperative pain and~     quality of life scores.~   "
38872|NCT02548234|"~     The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on~     movement strategies of the affected upper extremity and functional outcome in chronic stroke~     patients.~   "
26307|NCT02712814|"~     The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of~     provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD:~     hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative~     PVD and acquired neuroproliferative PVD, based on a patient's history and physical exam. The~     study will follow patients diagnosed with PVD, for one year, and evaluate the treatment~     outcome in the different subgroups. Investigators hope that conducting a prospective study,~     showing clinical benefit and improved outcome for patients classified according to this~     method may change the common practice of trial and error based treatment, and will improve~     clinical results.~   "
26308|NCT02712801|"~     This is a multi-center, randomized, controlled, open clinical trial. The trial will be~     carried out in five provinces in China. Pregnant women with HIV infection and at high risk~     of mother-to-child transmission of HIV will be identified. Their newborn babies who are at~     high risk HIV infection will be recruited and randomized into intervention and control~     groups. Children in intervention groups will receive ART and intensive HIV testing after~     birth. Children in control group will receive routine prevention of mother-to-child~     transmission services. All the included children will be followed up and their development~     and infection status will be recorded and compared.~   "
26309|NCT02712788|"~     The purpose of this study is to evaluate the usefulness of adding Milrinone to the current~     standard treatment for cerebral vasospasm.~   "
26310|NCT02712775|"~     Liver transplantation is the sole therapy for end-stage liver diseases and acute liver~     failure in children and adults. However, use of this life-saving technique is limited due to~     a severe shortage of donor livers. The number of transplants currently performed is~     approximately one-third of the number needed to accommodate the more than 16,000 patients~     awaiting an organ in the US. Over 20% of patients on the liver transplant waiting list die~     prior to transplantation due to organ shortages. The median waiting time in 2011 was over~     300 days. Poor immediate graft function and primary non function (PNF) are clinically~     significant events, especially in recipients of marginal livers (elderly donors, extended~     cold storage time, or steatosis). PNF has dramatic effects on patient morbidity and~     mortality, necessitating prolonged and expensive stays in intensive care units, and~     re-transplantation is the only life-saving therapy in patients with failing liver grafts due~     to PNF. This further exerts greater burden on the already scarce donor organ pool.~     Furthermore, biliary strictures and ischemic cholangiopathy, as a result of severe ischemia~     reperfusion injury, cause prolonged hospital stay, long-term complications, and increased~     costs. Targeted treatments, such as the one proposed in this application, will reduce the~     need for re-transplantation, reduce biliary injury, and potentially increase the number of~     donor organs available.~   "
26311|NCT02712762|"~     This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host~     Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival~     redness and tear stability. Hence, the investigators expect to find an increased in~     inflammatory cell population in GVHD conjunctival samples.~   "
26312|NCT02712749|"~     The Investigators verify the effectiveness of Binaural Beats as premedication instrument~     in elderly patients submitted to major surgery, in order to reduce the preoperative stress~     and possibly limit the use of sedatives and anti-anxiety medications.~   "
26313|NCT02712736|"~     The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the~     impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary~     and alternative medicine use in patients with PSC.~   "
26314|NCT02712723|"~     The purpose of this study is to determine if ribociclib in combination with letrozole for 24~     weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative~     Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with~     letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.~   "
26315|NCT02712710|"~     The purpose of this study is to investigate the effect of functional knee brace in the~     subjects with medial compartment knee OA.~   "
26316|NCT02712697|"~     The present study was designed to identify the efficacy and safety of Integrative Medicine~     by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy.~     Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and~     Metabolomics.~   "
26317|NCT02712684|"~     In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic~     strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar~     detection of clinically significant prostate cancer?~   "
26318|NCT02712671|"~     Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the~     reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis~     (MTb). This risk is reduced but not completely eliminated when HIV is treated with~     antiretroviral therapy (ART). Both the British HIV Association (BHIVA) and National~     Institute of Health and Care Excellence (NICE) suggest testing for latent TB infection in~     HIV infected individuals, but use different criteria. The cost -effectiveness of either~     approach has not been assessed, nor is testing widespread. A certain proportion of HIV~     infected subjects in Africa have MTb detectable in their sputum despite not having symptoms~     (such as cough or weight loss), nor changes on a chest x ray. It is unclear if this happens~     in lower TB prevalence areas such as the United Kingdom (UK). We intend to test a cohort of~     HIV infected subjects for evidence of latent TB using a tuberculin skin test (TST) and~     Interferon Gamma Release Assay (IGRA), ask about symptoms (using a standardised~     questionnaire) and to induce sputum using a saline nebuliser, to detect MTb using microscopy~     and culture, and newer nucleic acid amplification (genetic) techniques. Some patients,~     despite being exposed to TB in the past, will not mount a response using an IGRA or TST,~     which maybe due to an abnormal immune response. This lack of response seems more common in~     HIV. By investigating the number of patients with positive TST, IGRA, chest X ray and~     evidence of MTb in their sputum, in the context of place of birth, previous exposure to TB,~     CD4 count and other medications, we can assess the cost- effectiveness of systematic TB~     screening and the use anti-TB antibiotics to prevent reactivation of TB. In time, we will be~     able to answer important questions about the time taken to reactivate TB in individuals with~     HIV who do or don't take preventative anti-TB medications in the UK.~   "
26319|NCT02712658|"~     The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle~     fatigue in trained young men.~   "
26320|NCT02712645|"~     This study is being performed to collect blood for the development of noninvasive tests that~     can screen for or diagnose cancer. Blood samples will be collected from women who are~     scheduled to have breast biopsies.~   "
26342|NCT02712359|"~     The purpose of this study is to evaluate the persistence of hepatitis A antibodies,~     approximately 8 years and 10 years post vaccination with the complete series of Havrix (2~     doses) and the partial series completion (1 dose).~   "
26321|NCT02712632|"~     The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet~     the planned inclusion criteria. The study aims to investigate biomarkers associated with~     diabetes progression, therapeutic response, diabetes complications and related traits, and~     specifically to investigate mechanisms of action and response to metformin. The study will~     specifically target patients who have been diagnosed within the past 2 years and follow up~     will be by linkage to electronic health record data. Up to 6,000 patients will be recruited~     into the study over a period of 2-3 years with a primary aim to identify 1000 of these~     patients who should be suitable to be started on metformin therapy.~      Most patients will undergo a single screening visit lasting approximately 20 minutes~     conducted on an outpatient basis. Patients commenced on metformin therapy will need to~     attend a second clinic visit to be carried out between 4-6 months after initiation of~     metformin therapy.~      Up to 9 health boards will be approached regarding participating in the study, and it is~     estimated that between 4-6 diabetes patients will be recruited into the study each week, at~     each site.~      All screened patients will provide consent for data linkage and longitudinal follow up and~     their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection~     into the resource will be managed by the co-ordinating centre study team based at the~     University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository~     and access to samples and data will be managed by the Tayside Biorepository on behalf of the~     whole of Scotland.~   "
26322|NCT02712619|"~     Two doses of metformin with 12 hour interval~        -  low dose group (375/250 mg)~        -  high dose group (1000/1000mg)~   "
26323|NCT02712606|"~     A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo,~     Irvine, CA, USA) in children with cyanotic congenital heart disease~   "
26324|NCT02712593|"~     This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite~     concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a~     placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will~     receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™~     and one quarter will reveive the placebo.~   "
26325|NCT02712580|"~     This study will determine the effect of the wireless micro current stimulation in pediatric~     deep dermal burns and scald injuries. The clinical trial ist designed as a blinded,~     placebo-controlled, randomized, prospective, single-center study.~   "
26326|NCT02712567|"~     SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide~     access to TH-302 for patients currently receiving and benefiting from single agent TH-302~     therapy as part of the Phase III TH-CR-406/SARC021 study.~   "
26327|NCT02712554|"~     The purpose of this study is to assess the abuse potential of CL-108 tablets, including the~     abuse deterrent effects of promethazine, following oral administration, relative to~     hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid~     users.~   "
26328|NCT02712541|"~     The purpose of this study is to determine whether there is an association between adverse~     physical and/or psychological outcome in ICU survivors and the caregiver burden for their~     relatives.~      We hypothesize that relatives to ICU survivors with an incomplete physical and/or~     psychological recovery three months after ICU stay report a higher caregiver burden.~   "
26329|NCT02712528|"~     Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine~     the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac~     surgery include patient's recovery in cognitive function from the postoperative residual~     effects of anesthetics, such as opioids and sedatives, administered during intraoperative~     period. Therefore employing anesthetic regimens which can provide earlier recovery in~     cognitive function would be beneficial in facilitating fast-track cardiac surgery with~     earlier postoperative extubation and discharge from the intensive care unit (ICU).~      Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative~     hypnosis in the ICU.~      The present study compares the time for reaching BIS greater than 90 after using 2 different~     anesthesia regimens for cardiac surgery, remifentanil-based regimen and~     sevoflurane-sufentanil balanced regimen.~      Analyzing the changes immediately after cardiac surgery would be useful to determine the~     degree of patient's postoperative emergence.~      Materials and Methods:~      During study period, patients undergoing elective coronary artery bypass graft surgery in~     Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen~     consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS~     40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min)~     balanced regimen in Group S.~      All patients get intravenous patient controlled anesthesia consisting of alfentanyl and~     ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered~     during postoperative 2 hours in Group R.~      As a primary objective, inter-group difference in the time for achieving BIS greater than 90~     is determined.~   "
26330|NCT02712515|"~     Essential tremor (ET) is among the most common movement disorders, and is the most prevalent~     tremor disorder. It is a progressive, degenerative brain disorder that results in~     increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2%~     of the population) and estimates from population studies worldwide range from 0.4% to 6.3%.~     ET is directly linked to progressive functional impairment, social embarrassment, and even~     depression. Intention (kinetic) tremor of the arms occurs in approximately half of ET~     patients, and is typically a slow tremor (~5-10Hz) that occurs at the end of a purposeful~     movement, and is insidiously progressive over many years. Based on direct and indirect~     neurophysiological studies, it has been suggested that a pathological synchronous~     oscillation in a neuronal network involving the ventral intermediate nucleus (Vim) of the~     thalamus, the premotor (PM), primary motor (M1) cortices, and the cerebellum, may result in~     the production of ET. In spite of the numerous therapeutic modalities available, 65% of~     those suffering from upper limb tremor report serious difficulties during their daily lives.~     Deep brain stimulation (DBS) has emerged as an effective treatment option for those~     suffering from medically refractory ET. The accepted target for ET DBS therapy is the Vim~     thalamus. Vim projects to PM, M1, and supplementary motor areas (SMA) and receives afferents~     from the ipsilateral cerebellum. Moreover, electrophysiological recordings from Vim during~     stereotactic surgery have identified tremor cells that synchronously discharge with~     oscillatory muscle activity during tremor. Clinical and computational findings indicate that~     DBS suppresses tremor by masking these burst driver inputs to the thalamus. The overall~     goal is to investigate the neural signatures of tremor generation in the thalamocortical~     network by recording data during DBS implantation surgery. Investigators will record data~     from the macroelectrode implanted in the Vim for DBS therapy, and through an additional~     6-contact subdural cortical strip that will be placed on the hand motor cortical area~     temporarily through the same burr hole opened for the implantation of the DBS electrode.~   "
26408|NCT02711501|"~     The aim of this study was to investigate if using lasers instead of scalpel for flap~     advancement in bone augmentation procedures would reduce post-operative swelling and pain.~   "
26331|NCT02712502|"~     Inflammatory paranasal diseases are among the most common diseases in ENT In Russia,~     puncture method has been conventional approach to treatment of maxillary sinusitis. However,~     this procedure is associated with a number of drawbacks A promising trend for the treatment~     of purulent sinusitis is a reasonable antibacterial therapy Fluoroquinolones, particularly~     levofloxacin, are highly active against pneumonocci and are more active vs. the drug~     products of the second generation against intracellular agents (Chlamydia spp., Mycoplasma~     spp., M. tuberculosis, rapidly growing atypical mycobacteria (M. avium, etc.).~      Due to high activity against the agents causing bacterial upper and lower respiratory tract~     infections they are sometimes called respiratory fluoroquinolones~   "
26332|NCT02712489|"~     A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up~     of the volunteers of the ISS T-003 trial in order to evaluate the persistence of vaccine~     immunogenicity as well as of the immunological and virological effects induced by the~     therapeutic immunization with Tat.~   "
26333|NCT02712476|"~     Although mannitol is used for brain relaxation during neurosurgery and in the treatment of~     raised intracranial pressure; there is not a consensus on its safe and effective dose, the~     duration of its administration and its use in combination with loop diuretics. This study~     aimed to compare the effects of the mannitol alone and in combination with furosemide in~     different doses, on the brain relaxation, electrolyte, lactate levels of the blood,~     peroperative fluid balance and the volume of the urine in supratentorial mass resection~     surgeries.~      This prospective, randomized, double blind, placebo controlled study included fifty one~     patients (ASA I-III) scheduled for elective supratentorial mass resection surgery. The~     patients were randomized into three groups for investigation of the effects of mannitol~     alone and in combination with furosemide in different doses. Blood sodium, potassium,~     chlorine, lactate, urine and osmolarity levels were recorded. The brain relaxation score~     (BRS) was evaluated twice by the surgeon using a 4 point scale (1=very good, 2=good, 3=bad,~     4=very bad); at dura opening, and 30 minutes after the administration of the study drug.~   "
26334|NCT02712463|"~     The primary purpose of the study is to compare the rate of hospitalization associated with~     psychotic relapse in participants with schizophrenia treated one year before with oral~     antipsychotics and one year after with long acting injectable atypical antipsychotics.~   "
26335|NCT02712450|"~     According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French~     911) calls concern elderly patients above 75 years of age. For these patients, the clinical~     pathway should be decided on the basis of the symptomatology described during the call, but~     also with the gathering of specific data such as medical social and psychological~     evaluation. These items allow the regulating doctor to assess comorbidity, on-going~     treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient~     expectations and needs.~      However, data collected in order to assess the situation on the phone and take the~     orientation decision are mainly limited to the severity of clinical symptoms. Medical,~     psychological and social aspects are rarely gathered, for several reasons :~        -  Phone call shortness : emergency calls should be treated quickly~        -  Regulating doctors are not trained to take in account the specificities or geriatric~          patients in their decision making. Besides, they are not informed about alternatives to~          the hospital emergency department, such as geriatric channel system.~      An observational study was performed in 2012 on 692 calls about elderly patients referred to~     the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency~     department. Regardless of severe cases hospital regulation, 55% of the least serious cases~     (liberal regulation) were transferred to an emergency department.~      Regulation is inadequate to elderly patients for whom 1) the situation assessment and the~     appropriate decision making require specific items that are not known by regulating doctors,~     2) the medical care and the clinical pathway could be improved by the knowledge of on-field~     geriatric channel, 3) the emergency department care is particularly long, 4) and could be~     pernicious to younger patients.~      1920 patients will be recruited between January 2016 and August 2017, including a 6 months~     wash-out in order to train regulating doctors. This training will include geriatric~     patient's specificities, and geriatric channels. A 12% difference between the 2 groups~     (before and after the training) is expected, considering a 80% statistical power. The design~     is a time series experiment.~   "
26336|NCT02712437|"~     Women with early stage breast cancer may experience difficulty falling asleep or staying~     asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia.~     Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use~     of medications for sleep and an overall decrease in quality of life.~      The investigators have developed an internet-based website that is designed to help people~     manage symptoms typically experienced by breast cancer survivors, including insomnia,~     fatigue, pain and overall poor quality of life. The investigators want to learn whether this~     type of treatment can reduce chronic insomnia and improve the way subjects feel using both~     questionnaires and a special form of a wrist watch. This information may help the~     investigators better manage sleep difficulties in subjects who experience these symptoms~     after diagnosis of their breast cancer.~   "
26337|NCT02712424|"~     DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed~     with BCG to determine if immunization reduces the risk of TB infection~   "
26338|NCT02712411|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and~     co-administration of HGP1201, HIP1402 in healthy male volunteers~   "
26339|NCT02712398|"~     The objective of this study is to collect additional data on safety, performance and~     effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia~     repair at high risk for surgical site occurrence (SSO).~   "
26340|NCT02712385|"~     BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI~     with TIA survivors often being left with considerable functional impairment. TIA and strokes~     share common risk factors with cardiovascular disease. Cardiac rehabilitation~     post-myocardial infarction has shown significant reductions in morbidity and mortality, with~     home-based programmes producing better adherence and similar outcomes to hospital-and~     community-based programmes. However, the value of rehabilitation programmes for stroke~     prevention following a TIA or minor stroke is unclear.~      AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Manual', for~     TIA/minor stroke patients can be developed, using MRC guidelines for developing complex~     health service interventions, from an approved home-based cardiac rehabilitation programme~     (the 'Heart Manual') and to pilot a 12-week trial of the novel programme.~      METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first~     TIA/mild stroke will be invited to participate. The novel home-based programme manual will~     be developed following systematic reviews of the literature and qualitative exploration with~     the target population, using focus groups. A feasibility study will then be developed into a~     pilot trial. The pilot trial will recruit to 3 different treatments: (1)standard care;~     (2)standard care plus the manual; (3)standard care, manual plus a pedometer (to further~     promote physical activity). Interviews and focus groups will be employed to assess the~     interventions' acceptability. The intervention, 'The Healthy Brain Manual' will be refined~     and modified at all stages of the research.~      CONCLUSIONS - The findings will inform the development of a novel secondary prevention~     programme, 'The Healthy Brain Manual', for TIA/minor stroke patients and of a trial to test~     its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.~   "
26341|NCT02712372|"~     This is a Phase I, first-in-human (FIH) study to assess the safety, tolerability,~     pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single and multiple~     ascending doses in healthy male subjects~   "
26343|NCT02712346|"~     The primary goal of the study is to determine the safety and tolerability of ambrisentan. It~     is also expected that ambrisentan will improve blood flow in the lungs, decrease~     inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the~     use of select biomarkers in evaluating sickle nephropathy.~   "
26344|NCT02712333|"~     This study aims to detect serum metabolite changes, as well as other health indicators with~     the intervention of air purifiers on a randomized, crossover, double-blind trial.~   "
26345|NCT02712320|"~     This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after~     the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain~     eligible for continued treatment with androgen deprivation therapy. Subjects participating~     in Protocol FP01C-13-001-EX will be followed for safety only.~   "
26346|NCT02712307|"~     The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x~     4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults,~     adolescents and children with streptococcal tonsillitis. Patients are recruited from 17~     primary Health care centres in the south of Sweden. Adult men and women, youth and children~     ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected~     tonsillitis and meeting the criteria in accordance with current treatment recommendations~     for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings~     of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for~     Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be~     prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary~     including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days~     after last intake of PcV the general practioner make a clinical judgement if the patient has~     recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or~     new symptoms of sore throat is present, if adverse events have been noted or of any extra~     physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus~     group A, C and G are made at randomization and five to seven days after last intake of PcV.~     A study nurse will contact the patients one month and three months after the last treatment~     day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or~     possible complication, those patient records will be examined.~   "
26347|NCT02712294|"~     Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic~     response, pulmonary function and exercise capacity.~      Non-pharmacological interventions are low cost and can significant enhance outcomes in these~     patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable~     therapeutic approach in patients with functional limitations, particularly those that~     present with difficulty to perform exercise protocols.~      Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and~     quality of life of patients with PH.~      Material and methods: prospective randomized controlled study with a control group (GC, n9)~     and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk~     test (6MWT) were assessed before and after the NMES protocol.~      Results: the GE presented with a significant improvement in distance walked in the 6MWT,~     cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and~     social aspects of the questionnaire Short Form Health Survey-36.~      Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in~     improved exercise capacity, quality of life and lung function testing.~   "
26348|NCT02712281|"~     The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent~     training intervention designed to assist parents in increasing the variety of foods eaten in~     children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include~     specific techniques to manage mealtime behavioral challenges and introduce new foods.~   "
26349|NCT02712268|"~     This study tested the efficacy of an easy-to-use checklist aimed at supporting the~     therapeutic reasoning of physicians in order to reduce inappropriate prescribing and~     polypharmacy in elderly adults admitted to an internal medicine unit.~   "
26350|NCT02712255|"~     THE AIMS: The project aims at investigating of the effects of three types of planning~     (individual planning, collaborative planning, and dyadic planning) on physical activity.The~     influence of three planning interventions are compared with an active control condition,~     including physical activity education. PARTICIPANTS: The effects of the interventions are~     evaluated among dyads of patient and his/her partner. The patients with physical~     activity-related chronic diseases (cerebrovascular diseases or diabetes) will be enrolled. A~     minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The~     interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
26351|NCT02712242|"~     Backgroung: Various agents are used to reduce post-operative complications associated with~     palatal donor site surgery for free gingival graft (FGG) harvesting. This study was~     conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.~   "
26352|NCT02712229|"~     The overall goal of this study is to test whether a nurse-led intervention to improve~     provision of primary palliative care within oncology practices (CONNECT) can decrease~     morbidity for patients with advanced cancer and their caregivers.~      The specific aims are to:~      Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom~     burden, and mood at 3-month follow-up.~      Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.~      Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.~   "
26353|NCT02712216|"~     The purpose of this research study is to determine which sites are best suited for~     laparoscopic entry of bariatric trocars in the morbidly obese population.~   "
26409|NCT02711488|"~     The objective of the project is to develop, implement and evaluate a prevention program for~     obesity among adolescents in Brazil combining the primary care health system implemented in~     the country in recent decades with primary prevention at schools.~   "
26354|NCT02712203|"~     Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live~     attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine~     (MMRV) in their second year of life.The purpose of this study is to assess the effect of the~     age at administration of the first dose on the reactogenicity and immunogenicity of the~     measles component of these vaccines.~      In addition, this study will evaluate if the effect of the age at first dose is modified by~     the type of vaccine administered.~   "
26355|NCT02712190|"~     The purpose of the study is to assess the efficacy of high-frequency non-invasive~     ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy~     subjets and patients with lung disease.~   "
26356|NCT02712177|"~     Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe,~     Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data~     showed that 4CMenB has a high reactogenicity especially when coadministered with other~     infant routine vaccines [1-2]. While this suggests that coadministration causes an~     interaction resulting in a greater risk of adverse events following Immunization (AEFI) only~     the AEFI after the 4CMenB dose and not those occurring after routine vaccine immunizations~     were reported, underestimating the total risk associated with immunization at separate~     visits. For financial and practical reasons, coadministration of infant vaccines is~     preferred to separate visits. Separate visits may however be preferred if the sum of the~     AEFI risk at each visit is significantly smaller than the risk with coadministration and/or~     if the AEFI has a lesser severity. The purpose of this study is to recalculate the risk of~     occurrence and severity of AEFI with the coadministration of Bexsero™ and routine vaccines~     compared to separate injections to assess the interaction occurring with co-administration.~     Investigators will also estimate the risk of recurrence of AEFI at subsequent immunizations~     with the 4CMenB and assess if this risk varies with separate or coadministration with~     routine vaccines. To achieve these purposes, investigators will perform a secondary analysis~     of the data of three randomized controlled trials (clinicaltrials.gov identifiers:~     NCT00657709, NCT00847145 and NCT00721396) that evaluated 5025 children aged 2 to 14 months~     of whom 4535 were randomized to receive 3 to 4 doses of 4CMenB concomitantly or~     alternatively with routine vaccinations (DTaP-IPV-HepB/Hib [Infanrix Hexa™], PCV7~     [Prevenar™] or MMRV [Priorix-Tetra™]) [1,2].~   "
26357|NCT02712164|"~     The purpose of this single-center, randomized, prospective cohort study is to evaluate the~     clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the~     biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor~     sites.~   "
26358|NCT02712151|"~     Laparoscopic cholecystectomy is associated with considerable postoperative pain and~     surgeon-administered local anesthetic infiltration is the standard practice for achieving~     post-operative analgesia. However, recent studies have shown that pediatric patients~     continue to experience significant pain during the first 24 hours.~      The investigators plan to conduct a prospective, double-blinded, randomized study where~     patients will be designated into either a test group receiving an ultrasound-guided~     transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and~     peri-portal sterile saline or the control group that will receive ultrasound-guided TAP~     block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team~     and surgical team will both be blinded as well as the research personal in the postoperative~     period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing~     laparoscopic cholecystectomy will be included.~      The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single~     shot transversus abdominis plane and rectus sheath blocks, are superior to local wound~     infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain~     related behavior and facilitating functional recovery.~   "
26359|NCT02712138|"~     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis~     of a Gilbert disease from plasma. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
26360|NCT02712125|"~     Objective: To assess the influence of maternal isosorbide mononitrate (IMN) vaginal~     supplementation in improving liquor volume in women with isolated oligohydramnios.~      Study Design: Prospective randomized interventional study. Materials and Methods: 100 women~     with singleton pregnancy about 28-36 weeks, with isolated oligohydramnios [amniotic fluid~     index (AFI) < 5] were enrolled in the study. Before the proposed intervention, the antenatal~     risk factors were studied. Patients received 20 mg isosorbide mononitrate (IMN) vaginally.~     Patient were followed after 24 hours then weekly. The treatment was continued till the~     liquor improved significantly or until delivery. Outcome measures; mean increase in liquor,~     intervention delivery interval, and neonatal outcome were studied.~   "
26361|NCT02712112|"~     Recent preclinical study has suggested a potential possibility that imatinib might promote~     tumor growth in the presence of secondary resistance mutations [10]. This result imply that~     intermittent dosing schedule of imatinib rechallenge might be better than continuous dosing~     schedule in terms of controlling tumors harboring secondary resistance mutations. In~     addition, in these heavily pretreated patients, even mild grade of toxicity may~     significantly impair quality of life, and intermittent dosing schedule may have an advantage~     in this context. Therefore, investigators hypothesize that intermittent dosing schedule of~     imatinib rechallenge might be feasible and effective in patients with TKI-refractory GISTs.~     This study will assess the feasibility of intermittent imatinib dosing schedule in patients~     with GISTs who had failures from both imatinib and sunitinib.~   "
26362|NCT02712099|"~     The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of~     morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative~     findings.~   "
26363|NCT02712086|"~     The main objective will be to evaluate the effect at 5 weeks of nutritional management~     associated with protein supplementation (adapted to the post-operative period) on the~     maintenance of lean body mass at the whole body in obese patients after a sleeve~     gastrectomy.~      Secondary objectives will assess protein intake, food safety, the effect of protein~     supplementation on body fat in the entire body and the metabolic rate and the impact on~     quality of life and post-operative joint pain.~   "
26732|NCT02707289|"~     Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites,~     during up to 3 years and transferred to Given Imaging. Demographical data and medical~     history will be collected. Capsule transit time in the different sections of the GI will be~     evaluated.~   "
26364|NCT02712073|"~     In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold~     standard in France for colorectal cancer screening in populations at risk. However, it has a~     number of limitations. The quality of the bowel preparation is a critical step for the~     successful completion of this examination. The occurrence of interval cancers raises the~     problem of missed lesions. A literature review showed that there were differences between~     the endoscopy units on quality standards for bowel preparation. The rate of unprepared~     colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516~     colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate~     substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008.~     The establishment a predictive score for quality of bowel preparation based on a~     self-administered questionnaire completed by patients during the pre-colonoscopy~     consultation, would help identify patients at risk of poor preparation in order to optimize~     the prescribed preparation in this consultation.~   "
26365|NCT02712060|"~     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of~     inherited connective tissue disorders characterized by joint hypermobility, skin~     hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage~     defects, craniofacial abnormalities and increased pharyngeal collapsibility have been~     proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on~     questionnaires that EDS patients might be more frequently affected by OSA and sleep~     disturbances than the general population. However, the actual prevalence of OSA in children~     and adolescents with EDS is unknown.~      The primary objective of this study is to assess the prevalence of OSA in children and~     adolescents with EDS (25) compared to a matched control group (25). The secondary objective~     of this pioneer study is to assess the quality of life in children and adolescents in EDS in~     comparison to healthy children and adolescents.~   "
26366|NCT02712047|"~     For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2~     receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric~     oxide (FeNO) is a non-invasive airway inflammation marker.~      In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose~     study, the duration of action of fluticasone furoate (FF) will be determined by monitoring~     the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in~     asthmatic subjects.~      Subjects who meet the eligibility criteria will participate in the following two treatment~     periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will~     be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be~     followed by a 21-day monitoring/washout period before crossing over to the next treatment~     period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored~     up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).~   "
26367|NCT02712034|"~     The primary aim of this study is to measure and explain the impact on long-term opioid use~     when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health~     system (A-CHESS).~   "
26368|NCT02712021|"~     Lycra garments have recently been used for children with cerebral palsy, with favorable~     effects on alignment, biomechanics and neuromuscular activity. The aim of the present study~     is to determine the efficacy of a Lycra suit in improving motor function and static balance~     in children with cerebral palsy. The children included in this study will be part of a~     prospective project on children with cerebral palsy, older than 4 years of age, and their~     families regularly followed at the Child Neurology Unit of the Catholic University of Rome.~   "
26369|NCT02712008|"~     The primary objective of the study is to compare the efficacy of intravitreal~     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in~     improving best corrected visual acuity (BCVA) in patients with diabetic macular edema (DME).~   "
26370|NCT02711995|"~     Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor~     (EVT), but results are not universally beneficial to all patients. Inconsistent results are~     noted in the literature and are consistent with the PI's clinical experience. Injection~     augmentation, a well-established treatment for glottic insufficiency, which is a prominent~     factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied.~     By treating patients at separate times with botulinum toxin and injection augmentation in an~     unblinded prospective crossover treatment study, we can assess functional outcomes of these~     two treatments with the population of patients with Essential Voice Tremor (EVT).~   "
26371|NCT02711982|"~     The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary~     mechanism of injury. At present, no studies validate a particular approach to the management~     of TON. There are three management lines for these patients that include 1)observation~     only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical~     intervention. Studies have shown that forces applied to the frontal bone and malar eminences~     are transferred and concentrated in the area near the optic canal. The tight adherence of~     the optic nerve's dural sheath to the periosteum within the optic canal is also thought to~     contribute to this segment of the nerve being extremely susceptible to the deformative~     stresses of the skull bones. In this study, investigators aim to make a randomized~     controlled trial to certify the efficiency of optic nerve canal decompression for TON~     patients.~   "
26372|NCT02711969|"~     An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in~     patients with unresectable locally advanced or metastatic Gastric cancer failed to standard~     therapy.~   "
26373|NCT02711956|"~     This is an open label, non-randomized, Phase 1b, dose escalation and dose confirmation study~     of ZEN003694 in combination with enzalutamide in patients with mCRPC.~   "
26374|NCT02711943|"~     Chronic prostatitis is a common disease in men with the following typical symptoms~     decreasing the ability to work and quality of life: pain, urination disorders, copulatory~     dysfunction.~      Following study is conducted to study Levofloxacin in chronic prostatitis.~   "
26410|NCT02711475|"~     Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal~     polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or~     carcinoma in this kind of polyps is very low, a remove and discard technique has been~     proposed.~      The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes~     equipped with high definition, magnification and optical filters.~   "
26375|NCT02711930|"~     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive~     care units (ICU). This syndrome is associated with high morbidity and mortality. In~     management of ARDS patients, lung protective ventilation and prone ventilation are key~     strategies which have shown survival benefits in recent years and now become standard part~     of care in these patient. Prone positioning used for surgeries in operation room has been~     reported with ocular complications, of which vision loss is one of the devastating~     complications. There is scarcity of literature on effect of prone positioning on~     intra-ocular pressure (IOP) in critically ill patients. The purpose of our study is to~     evaluate the effect of prone position on IOP in critically ill patients and follow up for~     other ocular complication among survivors.~   "
26376|NCT02711917|"~     Different concentration of sevoflurane was given to maintain anesthesia. The dose of~     propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and~     evaluated.~   "
26377|NCT02711904|"~     Condition of the State: (terminated, recruiting, etc.) Terminated~      Study Design: Main Objective:~      Compare the frequency and intensity of coughing at the time of extubation with two infusions~     of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through~     the technique of target controlled anesthesia~   "
26378|NCT02711891|"~     This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing~     (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to~     their fingertip prior to their second lance and the other half received the gel only.~   "
26379|NCT02711878|"~     The purpose of this study is to see if exercise is helpful for improving memory,~     concentration thinking abilities, physical function, and quality of life for adults aged 50~     to 89 years living with HIV and who have two or more cardiovascular disease risk factors.~     The study will test two kinds of intervention exercises: one group will walk for exercise~     and the second group will stretch for exercise. Members of both interventions will be asked~     to participate in one-on-one interviews/assessments, measures of physical functioning, and~     some sessions with others who are also enrolled in the study.~   "
26380|NCT02711865|"~     The main goal of this study is to employ a novel proteomic approach to identify predictive~     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)~     targeted therapy in epithelial ovarian cancer. It is expected that these predictive~     biomarkers will be applied to increase the response rate in selected groups of patients.~   "
26381|NCT02711852|"~     This long-term, continued treatment study will evaluate the long-term safety of duvelisib in~     patients with hematologic malignancies that were previously treated with duvelisib in a~     previous sponsor-approved study.~   "
26382|NCT02711839|"~     In order to response the increasing of aging population cause losing ability that need~     long-care needs, the project entitled 10-year long-term care program from Executive Yuan~     in 2007 is carried out to assist economically disadvantaged and disabled elderly to acquire~     daily nutrition. Therefore, the long-term care resident's nutritional status got more~     attention than before. Out of control in blood glucose will not only increase bed sores and~     urinary tract infection in tube feeding residents but also rise medical expenditures. The~     nutritional status of long-term care institutions, anyang homes and nursing home are~     generally bad in nutrition management due to high cost of nutritional supplements from~     foreign imports that cause the burden of families. In this study, we will recruit diabetic~     subjects that divide into white sweet potato group (experimental group) and commercial~     formula group (control group) by using randomized, parallel and open clinical study through~     tube feeding in sixty days.~   "
26383|NCT02711826|"~     The purpose of this study is:~        -  To see if polyTregs and/or donor reactive darTregs can reduce inflammation in a~          transplanted kidney.~        -  To find out what effects, good or bad, polyTregs or darTregs will have in the kidney~          recipient.~        -  To find out what effects, good or bad, taking everolimus after polyTregs or darTregs~          will have in the kidney recipient.~   "
26384|NCT02711813|"~     The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo~     in patients with active Systemic Lupus Erythematosus, not adequately controlled with current~     concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and~     pharmacodynamic parameters in this study population.~   "
26385|NCT02711800|"~     The investigators seek to conduct the first open-label trial of probiotics in young children~     to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the~     feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the~     middle-lower GI tract. Self-report measures and a laboratory task will be collected from~     children, ages 9-13 years of age, and self-report measures from their primary caregivers~     prior to and following a 30-day probiotic administration. Children who score above cutoff in~     anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited~     sample size and the iterative nature of intervention development, criteria for success at~     the pilot phase are based primarily on clinical rather than statistical criteria. The study~     personnel will do their best to keep and ensure the privacy and confidentiality of our~     participants; however, some of the risks of this study may include psychological discomfort,~     legal risks, and loss of confidentially.~   "
26386|NCT02711787|"~     Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an~     easily applied innovative solution to rehabilitation, because the hand can perform grasp and~     release activities wearing the device by mean of a flexible and light orthosis. Our~     objective on this research was to the robotic assisted motion and activity in additional to~     physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.~   "
26421|NCT02711332|"~     This is an open, single-centre trial investigating the impact of haemolysis after capillary~     blood collection to the measured potassium concentration in Plasma healthy subjects. Each~     subject will have four capillary blood collections on different fingers. Two on the right~     and two on the left hand. Additionally as a reference a venous blood collection will be~     conducted.~   "
26422|NCT02711319|"~     to optimize the functional outcome in early phase of gait rehabilitation in subacute~     incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to~     gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger~     improvement of gait function than with physical therapy alone.~   "
26387|NCT02711774|"~     Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain~     injured ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and~     may reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non~     invasive techniques. While invasive techniques show the real time values of ICP, they are~     associated with many complications like, intracranial bleeding and infection, occlusion of~     the catheter tip by blood, debris and difficult to locate ventricle in presence of cerebral~     oedema. All these drawbacks of invasive methods can be averted by employing non invasive~     techniques of ICP monitoring. Although they do not show a real time value but are excellent~     tools to detect presence or absence of raised ICP. Elevated ICP can be detected by~     Computarised tomographic scan (CT) or Magnetic resonance imaging (MRI) but , these~     techniques are time consuming and require transportation of a patients who may be unstable~     .The quick and non invasive nature of ultrasonography is fast becoming popular for rapid~     detection of elevated ICP at bedside in emergency and ICU by monitoring the optic nerve~     sheath diameter ( ONSD ). Its limitations notwithstanding, ultrasonographic ONSD monitoring~     is likely to be more reliable than clinical assessment in the diagnosis of intracranial~     hypertension especially, when patient is under sedation which precludes proper clinical~     examination. Therefore, in recent years ,among non invasive methods, bedside ocular~     ultrasonography to monitor ICP has gained popularity.~      Carbon dioxide being a potent modulator of cerebral vascular tone, alters the ICP by~     changing the size of cerebral vasculature and thereby, cerebral blood flow (CBF) and this~     action occurs very rapidly, over e period of few minutes. In a range of PaCO2 20mmHg to 80~     mmHg the cerebral blood flow changes in a linear manner. End tidal carbon dioxide~     concentration(EtCO2) is a surrogate measure of PaCO2 (especially in a haemodyanimically~     stable patient with healthy lungs ) and is routinely monitored continuously in patients~     subjected to general anaesthesia. To date there is very little literature on the effects~     changing EtCO2 on ONSD . This prompted us to conduct this study to find out the effects of~     different levels of EtCO2 on ONSD.~   "
26388|NCT02711761|"~     prospective randomized double-blind controlled study~   "
26389|NCT02711748|"~     The study aims to assess the regularity of the proceedings in the case of a patient with~     bradycardia ECG.~   "
26390|NCT02711735|"~     Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa~     trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant~     Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time~     point of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A),~     and if clinically safe as evaluated by an independent panel of experts (DSMB), another~     cohort of patients will be vaccinated at 12 weeks upon start of standard MDR-TB treatment~     (cohort B). All the patients will be followed up 8 weeks after vaccination.~   "
26391|NCT02711722|"~     Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients.~      Objectives:~        1. To investigate if NAVA targeted to moderate respiratory muscular unloading results in~          redistribution of ventilation to the dorsal regions of the lungs~        2. To verify if the redistribution of ventilation translates to a better gas exchange and~          to a potentially lung protective ventilation strategy (lower airway pressures)~        3. To verify the possibility to set NAVA at different levels of unloading, based on~          Neuro-Ventilatory Efficiency.~      Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of~     unloading.~      Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h,~     in weaning phase from mechanical ventilation.~      Study duration: 2,5h Number of subjects: 12~   "
26392|NCT02711709|"~     The purpose of this study is to define the natural history and causes of chronic critical~     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator~     wants to study a sub-population of sepsis patients that have intra-abdominal sepsis. The~     purpose of this research study is to define the acute changes in frailty (weakness,~     slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty~     with mobility and performing routine daily functions) after having an infection that is~     located in the abdominal cavity or torso. The investigator believes having severe infection~     contributes to acute and permanent changes in these areas, especially in those of advanced~     age.~   "
26393|NCT02711696|"~     The study assessed whether compete healing of duodenal mucosa in celiac patients with~     persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):~        -  could be achieved by adoption of a diet based exclusively on naturally gluten free~          products, with the elimination of commercially available processed food (GCED, Gluten~          Contamination Elimination Diet);~        -  may depend upon time of exposure to GFD.~      Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:~        -  cohort A: patients re-biopsied after three months on GCED;~        -  cohort B: patients re-biopsied after a minimum of further two years on standard GFD.~   "
26394|NCT02711683|"~     Alzheimer's disease (AD) is the commonest cause of dementia. There is no effective treatment~     to cure the disease. Cholinesterase inhibitors, such as donepezil, are widely recommended to~     patients with mild to moderate AD. But the cognitive function of most of the patients using~     donepezil gradually aggravate, with Mini-Mental State Examination(MMSE) score falling by 2~     points per year on average, and donepezil cannot effectively delay AD progress.~      DL-3-n-butylphthalide(NBP) is a synthetic chiral compound containing L- and D-isomers of~     butylphthalide. It is developed from L-3-n-butylphthalide, which was initially isolated as a~     pure component from seeds of Apium graveolens in 1978 by researchers of Institute of~     Medicine of Chinese Academy of Medical Sciences. Studies in the past several decades have~     demonstrated that NBP is effective in alleviating oxidative damage and mitochondria~     dysfunction, improving microcirculation. NBP was approved by the State Food and Drug~     Administration of China (SFDA) as a therapeutic drug for treatment of ischemic stroke in~     2005 Not only for ischemic stroke, NBP has been reported to increase the expression of~     N-methyl-D-aspartate subtype glutamate receptor 2B(NR2B) and synaptophysin in hippocampus of~     aged rats after chronic cerebral hypoperfusion and increasing brain acetylcholine level,~     which are important processes involved in learning and memory. It could alleviate the~     learning and memory deficits induced by cerebral ischemia in rats. A multicentre,~     randomized, double-blind, placebo-controlled trial conducted by Professor Jia investigated~     that NBP was effective for improving cognitive and global functioning in patients with~     subcortical vascular cognitive impairment without dementia and exhibited good safety over~     the 6-month treatment period. The pathogenesis of AD involved mitochondria dysfunction and~     microcirculation dysfunction, which are the action targets of NBP. Investigators observed~     that MMSE score lowering slowly when using NBP treatment in patients with mild to moderate~     AD already receiving donepezil. But investigators lack of system evaluation and follow-up.~     Hence, investigators hypothesized that NBP may have therapeutic efficacy for patients with~     AD and designed the present study.~   "
26395|NCT02711670|"~     Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at~     night as compared to the daytime. It will therefore be more effective in reducing kidney~     stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to~     have increased risk of kidney stones at night time.~   "
26396|NCT02711657|"~     To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and~     severe asthma and healthy controls.~   "
26444|NCT02711033|"~     This study investigates the safety and feasibility of laparoscopic-assisted total~     gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced~     gastric cancer and compares the early results of this procedure with open total gastrectomy.~   "
26397|NCT02711644|"~     Research has shown that a woman's lifestyle during pregnancy can predict the future health~     of a mother and her child. Improving the health of a mother during pregnancy can lead to the~     best health outcomes for mother and child in the short and long-term period. Currently there~     is a lack of understanding about how best to support women to achieve healthy weights during~     pregnancy. The aim of this study is to understand if additional lifestyle support, such as~     discussions about healthy eating and physical activity provided by a healthcare provider~     throughout pregnancy can help women achieve weights concordant with gestational~     recommendations.~      The healthcare providers in this study will be Registered Dietitians (RD). The intervention~     RD will be trained in Healthy Conversations, a supportive method of communication that~     utilizes open-ended questions to support patient-centered behaviour change. This allows~     women to explore health issues, identify barriers and discover solutions for improving their~     own health. This supportive prenatal counselling will occur with the intervention group~     concurrently while completing lifestyle questionnaires with the study RD. During these~     conversations, health goals will be made and will be followed up at future visits. The~     control group will complete the lifestyle questionnaires with the control RD; they will not~     receive additional lifestyle support at these visits. Women will be randomized into one of~     the two study groups and will be blinded to their study allocation. All participants will~     complete two in person visits and two follow-up telephone calls. Data will be collected on~     diet, physical activity, gestational weight gain, delivery, and infant outcomes.~      After this research is complete, the investigators hope to better understand the quantity~     and quality of additional support that may help women in Alberta achieve guideline~     concordant weight gain during pregnancy. If interventions can help women gain weight within~     the guidelines, pregnancy-related complications can be reduced. This information is also~     aimed at providing a better understanding of healthcare system requirements (i.e., type of~     providers and care model) in supporting women achieve healthy weights in pregnancy. The~     findings from this project have the potential to improve prenatal healthcare delivery across~     the province.~   "
26398|NCT02711631|"~     Regular exercise in patients who have heart disease is highly beneficial and improves~     quality of life and survival. Exercise training is considered a core component of cardiac~     rehabilitation (CR), which is a multicomponent program delivered to patients who have heart~     disease. However, it is severely underutilized because people simply don't have the time or~     the resources to travel to a CR centre to attend rehab appointments.~      The investigators have developed a novel virtual reality (VR) based CR exercise system~     (MedBike). This system consists of an exercise bike attached to a VR world; it makes~     exercise engaging and fun. Furthermore, patients can be monitored during exercise remotely~     over the internet. The investigators intend to perform a pilot randomized controlled trial~     in which 10 patients are assigned to the MedBike system and 10 to standard CR. The~     investigators think that the MedBike system will increase exercise program compliance by~     providing an enjoyable and engaging exercise experience which can be performed in the~     comfort of one's own home. The investigators think that this will improve fitness (primary~     endpoint) in these patients. If the investigators demonstrate that home based exercise is~     feasible, the investigators plan a larger study to prove that it is something that should be~     broadly implemented in patients with heart disease.~   "
26399|NCT02711618|"~     Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape~     contour I V3 for non-invasive fat reduction.~      The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on~     the abdomen.~   "
26400|NCT02711605|"~     Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction~     will be enrolled into two arms to receive three biweekly UltraShape treatments.~   "
26401|NCT02711592|"~     The objective of this study is to see how pain management and its outcomes are effected when~     pharmacogenomic testing is used to determine patient specific pain medication and dosing.~     Our goal is to determine if through the use of analgesic genetic testing, TKA post-operative~     patients will see a decrease in narcotic consumption, postsurgical opioid- related adverse~     reactions, and length of stay, overall NRS pain scores and while maintaining or improving~     their satisfaction scores.~   "
26402|NCT02711579|"~     the purposes of this study are to evaluate the acute electrophysiological response in brain~     cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the~     electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg~     twice-daily for 7 days) in healthy volunteer~   "
26403|NCT02711566|"~     Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke~     survivors. Robots can be programmed to interact with patients by guiding their movements, by~     monitoring their performance and by quantifying the type and degree of their impairment.~      A distinctive element of multiple sclerosis is the involvement of a variety of functional~     systems, in a way that is highly subject-specific. This requires a personalization of~     treatment, and continuous adaptation to changes in condition. This points to a need for~     integrating patient assessment, definition of rehabilitation protocols, their administration~     and the assessment of their outcome.~      The goal of this study is to assess, in persons with MS, the efficacy of a type of~     robot-assisted training that was specifically designed to counteract incoordination and~     muscle weakness (typical of MS), tailored to individual type and degree of impairment, when~     compared to simple movement training.~   "
26404|NCT02711553|"~     The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or~     merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or~     metastatic biliary tract cancer.~   "
26405|NCT02711540|"~     Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke~     rates following TAVI are roughly 3%. There are several device and procedure related~     characteristics which may increase the risk of stroke. We will examine if there is a signal~     in the UK registry. This will be important is TAVI is to be extended down to lower risk~     patient cohorts.~   "
26406|NCT02711527|"~     This is a randomized, open-labelled study to study the effect of the different acupoints~     combination under TCM treatment principles by fNIRS.~      The investigator aim to recruited 36 depression subjects and go through 6 acupuncture~     treatment sessions in 3 weeks. They will be divided into 2 groups by randomization. (Group A~     n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3~     consecutively weeks. In each treatment session, all subjects in both groups will receive the~     same amount of needle insertion ( total 14 needles) , all needles will be retained for 30~     minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted.~      Subjects in Group A will receive 14 needles based on the TCM theory Soothing liver-qi~     stagnation, all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝~     (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13),~     Qimen期門 (LR14).~      Subjects in Group B will receive 14 needles based on the TCM theory Soothing liver-qi~     stagnation and Tonifying the heart and the spleenand Invigorating the Yang Qi, all~     needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), ,~     Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui~     百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu~     (abbreviation: TDP) 特定電磁波譜 will be applied to Group B immediately after the needle~     insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists~     and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure~     will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and~     Guanyuan 關元(RN4).~   "
26407|NCT02711514|"~     Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs~     published literature~   "
26411|NCT02711462|"~     This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator~     blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation~     study in healthy subjects, females of non childbearing potential and males between the ages~     of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7~     cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are~     anticipated in the Multiple Dose (MD) portion of the study.~      Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1~     and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity,~     safety and tolerability. FDA review and agreement to move forward will take place before the~     remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be~     initiated.~      A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The~     duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include~     weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two~     doses).~   "
26412|NCT02711449|"~     To test whether 125 mg preoperative methylprednisolone intravenously can reduce~     postoperative pain after laparoscopy for suspected appendicitis and to test whether~     preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep,~     reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of~     recovery after laparoscopy for suspected appendicitis.~   "
26413|NCT02711436|"~     The aim of the study is to compare orbital and central nervous system (CNS) imaging with~     Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in~     children with mild, moderate or severe orbital cellulitis with medical indications for~     imaging.~   "
26414|NCT02711423|"~     This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab~     in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive~     a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly~     assign participants to receive a single open-label SC dose of ganenerumab at different dose~     levels according to safety assessments from Part I.~   "
26415|NCT02711410|"~     Background:~      Clopidogrel, an antiplatelet prodrug, is widely used for prevention of the recurrent~     cardiovascular events. CYP2C19 is one of the crucial enzymes for the activation of~     clopidogrel. Recent studies, mostly done in cardiovascular patients, showed association of~     the CYP2C19 genotypes with recurrent cardiovascular events. However, prospective data on the~     impact of the genetic variants in stroke patients are limited.~      Methods:~      Five hundred and eighteen Japanese non-acute stroke patients treated with clopidogrel were~     registered at 14 institutions. Three CYP2C19 variants (CYP2C19*2, *3, *17) were genotyped~     and the patients were classified into three clopidogrel metabolizer groups inferred from the~     CYP2C19 genotypes: extensive (EM: *1/*1), intermediate (IM: *1/*2 or *1/*3), and poor (PM:~     *2/*2, *2/*3, or *3/*3). The CYP2C19*17 carriers were excluded from the analysis. The~     antiplatelet effects of clopidogrel were assessed by Adenosine diphosphate (ADP) -induced~     platelet aggregation and vasodilator-stimulated phosphoprotein (VASP) phosphorylation,~     expressed as VASP index. The endpoint was the composite incidence of stroke, transient~     ischemic attack, myocardial infarction, revascularization, other thromboembolic disease, or~     cardiovascular death during 2 years of follow-up.~   "
26416|NCT02711397|"~     Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients~     should be followed-up with dietary interviews and serologic tests for CD markers to ensure~     adherence to the diet. However, none of these methods offer an accurate measure of dietary~     compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in~     stools as a marker of GFD adherence in CD patients and compare it with traditional methods~     of GFD monitoring.~      We performed a prospective, non-randomized, multicentre study including 188 CD patients on a~     GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary~     questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue~     transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA~     antibodies were measured simultaneously.~   "
26417|NCT02711384|"~     Introduction: Sevoflurane is the most volatile anesthetic used during CPB. In addition to~     the cardioprotective effect, Sevoflurane also promotes reduction in systemic vascular~     resistance and also an important role in anesthesia maintenance during surgery, preventing~     patients awaken in the intraoperative. To avoid the awakening during surgery, assessment of~     the level of consciousness through the bispectral index (BIS) has been the most common~     method used by anesthesiologists. During cardiac surgery the most critical moment may be the~     patient is awaken during the warm up phase of CPB. The monitoring of this phase with the BIS~     has become efficient as to alert the anesthetist that the patient may be waking up.~      Aims: The primary endpoint of this study is to determine the ideal minimum dose of~     sevoflurane (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery~     have no intraoperative awareness.~      Methodology: Dixon's up-and-down technique is a commonly used method to define MAC (27-30).~     The anesthetic concentration applied to the first patient is estimated by clinical~     experience. If there BIS values below 50, the concentration of inhalational anesthetic in~     subsequent patient is decreased by 20%. If the BIS show values greater than or equal to 50~     for a period ≥ 1 minute steadily, the concentration is increased by 20% in the next patient.~     In each series of patients, the pairs of independent cross in order measurements are~     identified. Logistic regression is used to determine the ideal minimum dose of sevoflurane~     (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery have no~     intraoperative awareness.~   "
26418|NCT02711371|"~     The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether~     and how social and emotional brain function are altered in dependent cannabis users relative~     to healthy non-using control subjects after a 28 supervised abstinence period. Previous~     research in cannabis users has predominantly focused on cognitive functions. Moreover,~     studies have implicated that observed deficits in cannabis users may regenerate after a~     prolonged abstinence period. Findings might provide important information with respect to~     relapse vulnerability.~   "
26419|NCT02711358|"~     The aim of the investigators study is to test the analgesic effect of rectal indomethacin~     during Intrauterine device insertion.~   "
26420|NCT02711345|"~     A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway~     alterations.~   "
26423|NCT02711306|"~     Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical~     features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired~     glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of~     pro-inflammatory cytokine and insulin resistance. The purposes of this study are going to~     investigate the effects of KGM noodle (KGN) as stable food on body weight, BMI, waist~     circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E,~     β-carotene and high sensitivity C-reactive protein (hs-CPR) in subjects with metabolic~     syndromerelation. The investigators will recruit MS patients (n=80) and the inclusion~     criteria of MS are according to the Bureau of Health Promotion, Department of Health in~     Taiwan (2007). The MS subjects are randomly assigned to placebo (n=40) and KGN (n=40)~     groups. Hopefully, the results of this study could evaluate the clinical associations of~     noodle plus Konjac Glucomannan as staple food on patients with MS subjects.~   "
26424|NCT02711293|"~     Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the~     potential to reduce key barriers to ART care retention. The primary endpoint of this trial~     is the effect of CHW-led home delivery of ART on the proportion of patients with a~     suppressed HIV viral load after six months follow-up. This is a cluster-randomized~     controlled trial set in Dar es Salaam's Temeke district. The unit of randomization is a~     healthcare facility with its surrounding neighborhoods. We matched all 18 healthcare~     facilities offering ART services in Temeke district into pairs based on having a similar~     number of patients currently on ART. In each pair, one cluster was randomized to the~     intervention and one to the control arm. The intervention consists of monthly home visits by~     CHWs to provide counseling and deliver ART to patients who are stable on ART, while the~     control is the standard of care (facility-based ART care and CHW home visits at least every~     three months without ART home delivery). In addition, within each study arm, half of the~     healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to~     standard counseling.~   "
26425|NCT02711280|"~     The purpose of this study is to determine whether Propofol and Sevoflurane affect the~     oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.~   "
26426|NCT02711267|"~     The overall aim of this clinical study is to investigate the ability of dermal open flow~     microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in~     the skin of healthy volunteers.~   "
26427|NCT02711254|"~     The purpose of this study is to evaluate improvement in pain and function following~     implantation of a new device, called the Phantom Knee System, in patients needing unloading~     of the medial compartment of the knee~   "
26428|NCT02711241|"~     The purpose of this study is to find out an optimal way of analgesia in case of acute~     infectious gastroenteritis the investigators are going to compare two medicines that are~     used on everyday basis (without being ever before subject to scientifical study): Dipyrone~     and papaverine The study is done in the Emergency Department setting. Thus, only first 6~     hours of treatment is included in study~   "
26429|NCT02711228|"~     The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous~     injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary~     immune deficiencies. The full study will consist of safety, efficacy and Quality of Life~     (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study~     are to determine tolerability and safety of biweekly IgPro20 injection regimen and to~     compare PK outcomes on weekly and biweekly IgPro20 therapy.~      Patients who have received and/or are currently receiving immunoglobulin G (IgG) in~     intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet~     inclusion/exclusion criteria.~      The study consists of two parts. In Part 1 of the study enrolled subjects will receive~     IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24~     weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly~     treatment with IgPro20 for 52 weeks, for both groups.~      Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a~     PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.~   "
26430|NCT02711215|"~     Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft~     and are the current first line of pharmacological antidepressive treatment. Yet, there is a~     missing link between this first molecular step in their mechanism of action and observed~     clinical improvement. We have determined to establish a framework combining genuine~     molecular and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human~     serotonergic system in order to predict antidepressant treatment response.~      Objectives:~        1. To predict antidepressant treatment response from data obtained using hybrid PET/MR~          with acute pharmacological challenge.~        2. To discriminate healthy from depressed subjects using this paradigm.~        3. To establish models connecting regional changes in occupancy of serotonin transporters~          (5-HTT) following citalopram infusion, with changes in brain activation and~          connectivity of major resting-state hub networks.~      Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.~      Materials and methods:~      40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS~     mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural~     imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a~     bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT~     occupancy with drug challenge, applied after 70min, in a single session. Scanning will be~     terminated 80min after challenge. MDD patients will receive subsequent escitalopram~     treatment with repeated evaluation of response for 3 months.~   "
26431|NCT02711202|"~     The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on~     two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade~     (infliximab) monoclonal antibodies in the early posttransplant period followed by either~     monotherapy based on tacrolimus or sirolimus.~   "
26445|NCT02711020|"~     The purpose of this study is to perform an efficacy study of Personal Construct Therapy,~     which focuses on the construction of self and others, for women diagnosed with fibromyalgia~     who have also comorbid depressive symptoms. To that aim, it will be compared with Cognitive~     Behavioral Therapy, which is an already well-established treatment in this area.~   "
28013|NCT02690467|"~     The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm~     needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in~     patients with diabetes treated with insulin.~   "
26432|NCT02711189|"~     Background:~      Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may~     affect how the body responds to alcohol. Researchers believe oxytocin may be a possible~     treatment for alcoholism.~      Objective:~      To test whether the hormone oxytocin affects the brain reward system. To see if it affects~     how people respond to alcohol and other rewarding things in life like food and seeing loved~     ones.~      Eligibility:~      Men ages 21-55 who have an alcohol use disorder.~      Design:~      Participants will have two 6-day inpatient study visits. They will have:~        -  Study medication or placebo given twice daily as a nasal spray.~        -  Height and weight measured.~        -  Medical history.~        -  Blood and urine tests.~        -  Breath tested for alcohol.~        -  Electrocardiogram.~        -  An alcohol administration session. In a bar-like room, where participants will consume~          four alcoholic drinks.~        -  Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong~          magnetic field. Participants will lie on a table that slides in and out of the~          cylinder. A device called a coil will be placed over their head. Participants will~          complete tasks on a computer screen.~        -  In another alcohol session. they will drink an alcoholic beverage then answer~          questions. Participants will get a tab for eight more drinks ($3.00 per drink). They~          may drink any of the drinks or take the money. Participants will hold and smell a glass~          of water and their favorite alcoholic drink.~        -  Heart rate and blood pressure will be monitored.~        -  Saliva samples will be collected~        -  Computer tasks and questionnaires.~      About one week after the end of visit 2, participants will return to clinic for a follow-up~     visit. Symptoms and side effects will be evaluated.~   "
26433|NCT02711176|"~     This study is conducted to investigate whether the efficacy of single-dose triple therapy~     (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to~     double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the~     treatment of H pylori infection.~   "
26434|NCT02711163|"~     The aim of this study is to assess the hypoallergenicity of a new thickened extensively~     hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a~     double blind placebo controlled food challenge, followed by a 3-month open feeding period.~   "
26435|NCT02711150|"~     The purpose of this study is to assess whether application of an epidural positioning device~     to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target~     area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant~     women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural~     positioning device applied. For each position, the size of the 'target area', defined as the~     visible length of the posterior longitudinal ligament will be measured at the L3-L4~     interspace.~   "
26436|NCT02711137|"~     This is an open-label, dose-escalation/dose-expansion study of INCB057643 in subjects with~     advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or~     a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further~     evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in~     select tumor types.~   "
26437|NCT02711124|"~     The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c)~     correlates to higher level of platelet reactivity assessed by impedance aggregometry in~     patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).~   "
26438|NCT02711111|"~     Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or~     both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally~     treated with a protraction facemask in order to stimulate forward growth of the upper jaw.~     This treatment option is often inducing unwanted side effects including mesial migration of~     the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects~     are often difficult to achieve with this approach, more pronounced class III malocclusions~     cannot be addressed by face mask therapy. These children cannot be treated during childhood~     and end up in major orthognathic surgery at full-grown age. To be able to treat also the~     more pronounced class III malocclusion and to minimize dentoalveolar compensations new~     treatment methods were developed which uses skeletal anchorage.~   "
26439|NCT02711098|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible~     for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality~     of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to~     the initial cardiac rhythm present during the initiation of resuscitation. Recent progress~     in the improvement of mortality and neurological outcome has been achieved over the last~     decade thanks to the systematic implementation of a period of targeted temperature control~     between 32 and 34 ° C in patients who benefited from the realization of at least one~     electrical external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period~     of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~      IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two~     temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest~     in non-shockable rhythm.~   "
26440|NCT02711085|"~     This study will explore the contribution of stress-system activity to pain and functional~     disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of~     symptoms after 3, 6 and 12 months post-injury.~   "
26441|NCT02711072|"~     SPINAL anesthesia is commonly used for cesarean section, and it has become a popular~     practice to add opioids to spinal solutions to enhance and prolong intraoperative and~     postoperative analgesia. high incidence of side effects was noted. is there any alternative?~   "
26442|NCT02711059|"~     The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism~     (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be~     useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after~     biochemical cure of pHPT.~   "
26443|NCT02711046|"~     Long standing oral submucous fibrosis(OSMF) is associated with involvement~      of the oral submucosa and the muscles of mastication leading to difficulty in mouth~      opening. Various surgical modalities are mentioned for release but each has its own~     limitations.The aim of the study was to evaluate the change in mouth opening in patients of~     OSMF after excision of fibrous bands followed by coronoidotomy and surgical defect coverage~     by single stage nasolabial flap.~   "
26446|NCT02711007|"~     After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade~     osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored~     apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure~     of first-line or second-line chemotherapy. Patients >14 years, progressing after standard~     treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until~     progression or unacceptable toxicity. The primary end point was progression-free survival~     (PFS) at 4 months. Secondary objectives were PFS, overall survival (OS), clinical benefit~     rate (CBR), defined as no progression at 4 months and safety.~   "
26447|NCT02710994|"~     This is a randomized, open-label, two-way crossover study to investigate the~     pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and~     Losec in Healthy Male Volunteers~   "
26448|NCT02710981|"~     This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure,~     and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle,~     women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic~     measurement of their endometrial thickness , and Doppler evaluation of their uterine~     arteries on the day of HCG administration. In 7th cycle, women (N = 36) were given usual~     dose of Clomiphene citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg~     sildenafil) twice daily from cycle day 8 till the day of HCG injection. Endometrial~     thickness and uterine artery Doppler were measured on the day of HCG administration.~   "
26449|NCT02710968|"~     Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal~     membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that~     minimize ventilator-induced lung injury, morbidity and mortality rates for babies with~     congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of~     prenatal lung compression and the subsequent impairment of pulmonary function following~     delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate~     the severity by relating the circumference of the lung contralateral to the hernia to the~     fetal head circumference (Lung to head ratio (LHR) and by noting the degree of upward~     herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR)~     prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While~     overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR <25% is~     associated with survival between 11-24%.~      The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore~     adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal~     egress of lung fluid during pulmonary development leading to increased lung tissue stretch,~     increased cell proliferation, and accelerated lung growth. European colleagues have~     developed intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal~     tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium~     group published summary results of FETO showing an improved survival in 175 patients with~     isolated left CDH from 24% to 49%. The goal of this pilot study is to study the feasibility~     of implementing FETO therapy in the most severe group of fetuses with left congenital~     diaphragmatic hernia (O/E LHR < 25%).~   "
26450|NCT02710955|"~     The aim of this study is to evaluate the efficacy of a new thickened formula on~     regurgitation~   "
26451|NCT02710942|"~     The goal for this pilot study is to assess the acceptability of two online self-guided~     programs for migraines. The programs are part of the investigators' collection of my~     Wireless Headache Interventions (myWHI). The Specialized Program for Headache Reduction~     (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help~     manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM)~     helps users to discover their headache triggers and provides recommendations for managing~     them. This pilot will also assess the feasibility of the study protocol to inform a full~     scale randomized controlled trial (RCT).~   "
26452|NCT02710929|"~     Specific Aims:~        1. To find the genetic variations associated with spatial working memory performance in~          patients with ADHD by using genome-wide association studies (GWAS);~        2. To find the genetic variations associated with spatial working memory performance in~          healthy subjects by using GWAS;~        3. To recruit a validation sample and to replicate the findings from the initial GWAS;~        4. To test whether genetic variations significantly associated with spatial working memory~          are also associated with ADHD.~   "
26453|NCT02710916|"~     Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions~     people affected in 2010. It is defined as a neurodegenerative disease characterized by a~     progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve~     excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity,~     its impact on quality of life and an existing treatment that can delay visual field damages,~     there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve~     head excavation performed either by ophthalmologists or glaucoma specialists is highly~     inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to~     30 to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus~     making this tool not accurate enough for screening purposes.~      Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and~     reproducible measurements of optic nerve head structures and retinal layers mainly related~     to the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have~     been developed to improve its diagnostic accuracy for glaucoma disease. The investigators~     therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls.~     All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg~     Engineering, Germany) and other study procedures in one single visit. All examinations~     performed on the subjects are non-significant risk.~   "
26464|NCT02710773|"~     Gait impairment is a common cause of disability in patients who have experienced a stroke~     and recovery of walking is a priority goal. Gait outcome is a significant factor that~     influences a patient's chance of returning to the social life activity and rehabilitation is~     an effective treatment for restoring gait in these patients. Learning to walk backwards~     correctly has been recommended to improve the movement components required for walking~     forwards. Several studies demonstrated that during backward walking the muscle activity is~     higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and~     the same motor program is used comparing to during the forward walking. It has been~     suggested that backward walking therapy may be promoted as a treatment strategy to improve~     gait in stroke patients.~      The main goal of this project is to investigate the effectiveness of the backward walking~     therapy on gait improvement and spasticity in post stroke patients.~   "
26733|NCT02707276|"~     The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation~     (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar~     depression. The investigators also aim to assess any cognitive benefits from regular LFMS~     treatments in older adults suffering from bipolar depression.~   "
26454|NCT02710903|"~     A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this~     1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of~     the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4~     groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects~     with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of~     IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and~     healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519;~     rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient~     procedures including oral examinations, oral prophylaxis or periodontal scaling and root~     planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples.~     Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B~     genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and~     inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis.~     Clinical outcomes will include measurements of periodontal disease progression and~     inflammation, such as clinical attachment level (CAL), pocket depth (PD), bleeding on~     probing (BOP), gingival index (GI), and plaque index (PI).~      Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal~     disease expression and local inflammatory response during stent-induced biofilm overgrowth.~      Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on~     cell-mediated, innate inflammatory response.~   "
26455|NCT02710890|"~     EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of~     intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 4 to < 17 years of age with~     epilepsy.~   "
26456|NCT02710877|"~     The study aims to determine whether the use of automated intermittent devices for labor~     analgesia could prevent the increase of instrumental deliveries, with same analgesia.~      Moreover it will evaluate if automated devices can allow a reduction of health-care burden.~   "
26457|NCT02710864|"~     The primary objectives of this study were to evaluate the incidence of congenital CMV~     infection in neonates, and assess the concordance of detecting congenital cytomegalovirus~     (CMV) infection in neonatal saliva and urine samples.~   "
26458|NCT02710851|"~     This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the~     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech~     CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers~     would be randomized to receive the 3 different formulations of the novel HPV vaccine or~     placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to~     a 0-1-6 month schedule. This is a double-blind study.~   "
26459|NCT02710838|"~     The gastric cancer is the second most frequently diagnosed cancer and the third leading~     cause of cancer death in China.80%-90% patients were detected at middle and later stage.The~     five-year survival rate for advanced gastric cancer patients is less than 10% due to the~     shortage of effective treatment method.The five-year survival rate for early gastric cancer~     patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods~     do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main~     method for confirming gastric cancer.But it is limited to identify early gastric cancer and~     it leads to the low diagnostic rate of early gastric cancer.~      Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric~     cancer, since the first report in the 1990s, people have been exploring in this field.~     Through intravenous injection of exogenous contrast medium, such as the indocyanine green,~     it makes mucosal lesions highlight,and avoids the interference of background light.If~     specific target molecular is linked to the contrast medium,the specific imaging of the~     lesion can be presented. What is more,due to the strong penetration power of infrared~     light,its imaging depth also increases significantly.Indocyanine green had also been~     demonstrated safe in clinical studies and widely used. On this basis,we apply for the~     research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its~     feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.~   "
26460|NCT02710825|"~     Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by~     EVENDOL scale surgery on children with congenital heart disease~   "
26461|NCT02710812|"~     The proposed study is an observational, prospective, multicenter study of patients~     undergoing neoadjuvant therapy for medium-low rectal cancer.~      Recently the investigators have published the findings of a multicenter Italian phase II~     study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in~     patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy~     (pCRT), showed a major clinical response and underwent a transanal local excision. Based on~     these results, an organ-sparing approach for patients showing a major clinical response is~     feasible without reducing the good results obtained with the standard treatment. While a~     phase III trial is the best way to compare the standard treatment with the organ-sparing~     approach (local excision or wait-and-see) it is impracticable and likely unethical. An~     observational study is therefore one of the best way to evaluate the impact that an~     organ-sparing approach may have on oncological outcomes, quality of life, and bowel function~     for patients with rectal cancer who, after a pCRT, show a clinical major/complete response.~      This phase II trial is designed to test the hypothesis that conservative treatments, in~     patients with low-mid rectal cancer who undergo a major or complete clinical response after~     neoadjuvant treatment, will be safe and effective compared to standard surgery.~      The investigators will compare rectum-sparing approaches to standard surgery, firstly in~     terms of rate of organ preservation at 2 years. Additionally they will compare survival~     outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete~     response, correlation between major and complete clinical response.~      To add value, the investigators will measure QoL in patients treated with rectum-sparing~     approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal~     amputation).~      Rectum-sparing approach can be considered clinically acceptable if percentage of~     conservation of the rectum at two years is not less than 50%.~      The collected data on 164 patients who underwent rectum-sparing allow to test the~     hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial~     test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it~     obtains a frequency of conservation of the rectum of not less than 87 cases.~      The analysis results will be reported in accordance with STROBE guidelines (von Elm et al.,~     2008). For all analyzes, continuous variables are described using the mean and standard~     deviation of position and appropriate measures when appropriate. Categorical variables will~     be described using the contingency tables.~   "
26462|NCT02710799|"~     The aim of this study is evaluate the effects of telephone teleconsultations to primary care~     physicians (compared to the state's referral protocol) in the referrals waiting list for~     endocrinological appointments.~   "
26463|NCT02710786|"~     To evaluate effect on comorbid disease and weight loss five years after Roux-en-Y gastric~     bypass (RYGB) surgery for morbid obesity.~   "
26561|NCT02709512|"~     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme~     versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate~     synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine,~     an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the~     malignant pleural mesothelioma cells will starve and die.~   "
26465|NCT02710760|"~     The purposes of this study are (1) to determine whether child nutrition-focused adoption~     encouragement messages focused on Quality Protein Maize (QPM) and the availability of small~     quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for~     young children, and (2) to determine whether consumption encouragement messages and~     techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to~     and health outcomes for young children.~   "
26466|NCT02710747|"~     To value the accuracy of the dosing algorithm published by the International Warfarin~     Pharmacogenetics Consortium in Chinese patients after heart valve replacement.~      To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated~     dose and actual dose in the Chinese patients.~   "
26467|NCT02710734|"~     The purpose of this study is to evaluate a bladder preserving approach for patients with~     muscle invasive bladder cancer using neoadjuvant accelerated Methotrexate, Vinblastine,~     Doxorubicin, and Cisplatin (AMVAC) followed by chemoradiation with intensity modulated~     radiation therapy (IMRT) and 5-Fluorouracil (5-FU) and Mitomycin C. Patients will have~     maximal transurethral resection, followed by three cycles of AMVAC. Once AMVAC is complete,~     patients will have a second maximal transurethral resection, then chemoradiation with IMRT~     and 5-FU and Mitomycin C, followed by a third maximal transurethral resection. Tolerability~     and efficacy will be evaluated with physical exams, adverse event assessments, quality of~     life questionnaires, labs, and CT/bone scans. Patients will be followed until 5 years status~     post completion of therapy.~   "
26468|NCT02710721|"~     The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as~     a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high~     metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life,~     reduction of side effects and possible reduction in tumor progression.~   "
26469|NCT02710708|"~     The primary objective is to assess the safety profile of YAZ in Chinese women, including~     adverse drug reactions (ADRs).~      The secondary objectives are to investigate the rate of unintended pregnancies, the cycle~     control for subjects with and without preceding abortion, the bleeding pattern of subjects~     with and without preceding abortion (including the abortion-related bleeding pattern) and~     the efficacy in moderate acne vulgaris.~      Another objective is to investigate the effect on dysmenorrhea.~   "
26470|NCT02710695|"~     Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little~     evidence exists about orthopaedic patient understanding of the common methods of managing~     musculoskeletal pain. Therefore, it is our aim to determine which discussion method best~     improves patient comprehension of common methods of managing pain.~   "
26471|NCT02710682|"~     Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent,~     painful syndrome of the elbow. It is refractory to conservative treatment measures,~     including rest, excentric and concentric exercises in approximately 20% of patients after 6~     months. Corticosteroid injections can provide relief in the short term. Mini-open surgery~     may be proposed when the conservative treatment fails and studies have shown an efficacy of~     70%. Ultrasound-guided tendon fenestration is a minimally-invasive technique which~     stimulates the physiological healing mechanisms of the tendon and appears promising for the~     treatment of chronic tendinopathies. To our knowledge, no studies have compared the~     US-guided fenestration technique to mini-open surgery for the treatment of chronic lateral~     epicondylosis.~      The primary objective of this pilot study is to compare the efficacy of US-guided~     fenestration to mini-open surgery to reduce pain and improve functional status in workers~     suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.~      This is a prospective single-blind randomized pilot study. Sixty-four subjects will be~     randomized into two intervention groups for treatment either by US-guided fenestration or~     mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow~     Evaluation (PRTEE) score at 6 month post-procedure.~   "
26472|NCT02710669|"~     Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of~     two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will~     randomize participants to (R)-propafenone, (S)-propafenone, or placebo.~   "
26473|NCT02710656|"~     A randomized multicentric study for endovascular treatment of patients with obstructive~     disease in the SFA (superficial femoral artery) and in the popliteal artery.~   "
26474|NCT02710643|"~     Phase II prospective multicenter study for stage I/II Follicular Lymphoma treated with~     involved-field radiotherapy (IFRT) at doses of 24 Gy) with or without Ofatumumab for 8~     weekly doses on molecular basis. Patients with positive basal Bcl-2 will be followed every 3~     months and with Bcl-2 detection every 6 months for 3 years. Patient with negative basal~     Bcl-2 will be followed every 3 months without further Bcl-2 detection.~      Ofatumumab treatment will be administered to:~        1. Patients with positive basal PCR for Bcl-2-IgH rearrangement in BM and/or PB, resulting~          still positive after IFRT;~        2. Patients with positive basal PCR for Bcl-2-IgH in~   "
26475|NCT02710630|"~     The primary objective of this trial is to investigate the relative bioavailability of five~     different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1,~     Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule~     formulation of Dabigatran Etexilate.~      The secondary objective is to evaluate and compare several pharmacokinetic parameters~     between the treatments.~   "
26476|NCT02710617|"~     The objective of this study is the evaluation of system accuracy following ISO 15197:2013~     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood~     glucose monitoring systems intended for self-monitoring of blood glucose by patients are~     stipulated.~      However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+~     and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use~     only on behalf of the IDT with one reagent system lot for each BGMS.~      Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)~   "
26477|NCT02710604|"~     This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of~     CMX157 at increasing dose levels.~   "
26745|NCT02707120|"~     Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered~     innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the~     regeneration deterioration and development of corneal ulceration, their fusion, and~     perforation The main characteristic in the NK is a decrease or absence of corneal~     sensitivity.~   "
26478|NCT02710591|"~     In Duchenne Muscular Dystrophy (DMD) there is an imbalance between the levels of calcium and~     sodium in the muscles cells which is thought to be important in the damage which occurs~     overtime. Sodium/proton type 1 exchanger (NHE-1) inhibition is an innovative pathway that~     has proved to efficiently prevent the accumulation of muscle damage (inflammation and~     fibrosis) in animal models of muscular dystrophies and heart failure. Based on prior safety~     and efficacy results in animal and humans, NHE-1 inhibition with Rimeporide represents a new~     therapeutic approach with no restriction on age and on genetic subtypes which could be~     combined to other treatments that restore or augment dystrophin.This study examines the~     safety and tolerability and effects on the muscles of rimeporide, in patients aged 6 to 14~     years with Duchenne Muscular Dystrophy (DMD).~   "
26479|NCT02710578|"~     Given the known driving behavior of Driving Under the Influence of Alcohol and some of its~     parallel to driving under the influence of cannabis, this supplemental study aims to~     validate the sensitivity of the primary and secondary outcome measures employed in a~     cannabis and driving study currently in progress.~   "
26480|NCT02710565|"~     Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial~     needle aspiration (TBNA) will provide additional samples. These samples will then be sent to~     Imperial College London to see whether a cell line can be grown.~      If growth is successful then the samples will be returned to our pathology department to see~     if grading is possible and then to compare these results with the previous diagnostic~     samples.~      The cell line samples will not be used for patient diagnosis.~   "
26481|NCT02710552|"~     The aim of the study is to compare the efficacy and safety of low-dose combination of three~     antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in~     arterial hypertension~   "
26482|NCT02710539|"~     Randomized comparison of once-daily fixed combiNation versus free-drug combination of three~     antihypertensive agents in arterial hypertension~   "
26483|NCT02710526|"~     Phase II, open label, randomized, two treatment group study designed to evaluate the steady~     state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous~     administrations of CAM2038.~   "
26484|NCT02710513|"~     The purpose of this study is to evaluate the healthy properties of a dietary intervention~     based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).~      The hypothesis is that the gut microbiota and metabolome, the nutritional status, the~     redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve~     in healthy subjects.~   "
26485|NCT02710500|"~     The proposed clinical trial is a double-blind, randomized controlled study with direct~     intramuscular injection of rAAVrh.74.MHCK7.DYSF.DV gene vector to the extensor digitorum~     brevis muscle (EDB). Two cohorts of subjects with dysferlin deficiency, each with proven~     mutations will undergo gene transfer. A minimum of three subjects will be enrolled into each~     cohort.~   "
26486|NCT02710487|"~     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory~     improvement in motor function reported by around 50% of patients affected by Parkinson's~     Disease (PD) after sleep and before taking their first dose of dopaminergic medications. The~     aim of this study is to test the hypothesis that objective and/or subjective improvement of~     motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at~     awakening from this sleep phase.~   "
26487|NCT02710474|"~     The purpose of this study is to compare neurodevelopment and activity in infants born very~     preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family~     Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).~      The study investigator hypothesizes that FNI will improve: i) neonatal~     electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and~     physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age~     (CA).~      The two-part study aims to:~        -  Part I - replicate efficacy from an earlier trial by conducting the study at multiple~          sites to allow for greater generalizability.~             -  SC, approximately 60 infants plus the parents~             -  FNI, approximately 60 infants plus the parents~             -  Term Controls, approximately 25 infants plus the parents - if enrollment not~               reached, enrollment may continue in Part II~        -  Part II - examine effectiveness by implementing FNI unit-wide so that every baby~          receives the intervention.~             -  FNI, approximately 60 infants plus their parents~   "
26488|NCT02710461|"~     The aim of this is study is to evaluate the acute effect of grape and pomegranate~     polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works~     about polyphenols have only considered a fraction of polyphenols, i.e., extractable~     polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called~     non-extractable polyphenols are ignored. In contrast, the effect of both extractable and~     non-extractable polyphenols will be considered in this study. Furthermore, the effect of~     both polyphenols as present in the food matrix and metabolites derived from microbial~     fermentation will be evaluated.~   "
26489|NCT02710448|"~     The study is to treat metformin dose-escalation diabetic subjects of all stages of renal~     failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a~     possible accumulation than those of plasma) to the therapeutic range. A number of 12~     patients by stage is considered, 60 patients in total.~   "
26490|NCT02710435|"~     The purpose of this study is to collect long term data of the Neovasc Reducer System in~     subjects with refractory angina pectoris.~   "
26491|NCT02710422|"~     The use of dehydrated human amnionic membrane allograft improves erectile function recovery~     (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic~     assisted radical prostatectomy (RARP) compared to a control group with no allograft.~   "
26511|NCT02710162|"~     Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment~     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and~     aspiration pneumonia. These sequelae necessitate timely identification of at risk~     individuals to ensure optimal management of oral intake and pulmonary function. The purpose~     of this study is to evaluate the discriminant ability of several non-invasive screening~     tools at detecting swallowing impairment in individuals with ALS.~   "
26512|NCT02710149|"~     The main purpose of this study is to explore the therapeutic effect of CD20-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of B cell malignancies.~   "
26492|NCT02710409|"~     Influenza is an acute respiratory disease caused by influenza viruses. There are three types~     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile~     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,~     sore throat, nasal congestion and general malaise. The main transmission of influenza is~     through those highly contagious aerosol droplets containing influenza virus passed from~     infected people to susceptible population. Each year in the fall and winter infection of~     influenza is widespread in various age groups, with high incidence rate. Although influenza~     is generally a self-limiting disease, but in children, the elderly (especially those above~     65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases~     such as diabetes or other certain diseases) and those with poor immunity function, influenza~     can easily lead to serious flu complications such as pneumonia, resulting in severe increase~     of morbidity and mortality.~      In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced~     by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct~     in healthy Chinese subjects aged 3 years and older.~   "
26493|NCT02710396|"~     The primary objectives are to determine if tumor genetics (non-synonymous mutation burden >~     200 mutations and mutational smoking signature [transversion high]) can predict durable~     clinical benefit (DCB) to pembrolizumab. The secondary objective is to determine if a~     combined genetic and immune (PD-L1, immune signature) analysis can predict durable clinic~     benefit better than either test alone. Our exploratory objectives are to identify and~     validate candidate neoantigens in vitro; and explore mechanisms of resistance to~     pembrolizumab.~   "
26494|NCT02710383|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of a cystic~     fibrosis disease from plasma~   "
26495|NCT02710370|"~     The purpose of this research study is to determine how gastric bypass surgery effects~     metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in~     animal models is change to the biology of the small intestine (Roux limb) and how glucose~     and other fuels are metabolized (or how the body digests and uses sugar and other fuels).~     This study will evaluate the role of the intestine in the beneficial metabolic effects of~     gastric bypass surgery. It specifically will examine whether the intestine increases its~     metabolism and its activity, and whether this results in an increase in fuel utilization.~     Thirty two (32) subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the~     time of gastric bypass surgery, a small piece of intestine that is usually discarded will be~     collected. At three time points over the first year after surgery, intestinal samples will~     be obtained by endoscopy or insertion of a lighted flexible tube through the mouth. Blood~     samples will be taken at all time points, as well. All samples will undergo comprehensive~     metabolic analyses. Comparisons will be made between the two groups to understand the~     metabolic changes over time and if there are differences between the two groups.~   "
26496|NCT02710357|"~     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture~     retained by a single implant. The study hypothesis is that SIMO is more effective but more~     costly than the conventional denture, though this incremental cost is relatively low for the~     offered effectiveness in terms of clinical and patient-reported outcomes.~   "
26497|NCT02710344|"~     The overarching aim of this study is to evaluate whether telehealth leads to better mental~     health outcomes and decreased use of acute and crisis-based mental health care services by~     randomly assigning 300 people with serious mental illness (SMI) and psychiatric instability~     receiving services at 1 of 2 community mental health centers (CMHCs), each of which offers~     integrated behavioral and primary health care, to either Health Home Usual Care alone or~     telehealth plus Health Home Usual Care for 12 months, with assessments at baseline, 3, 6 and~     12 months.~   "
26498|NCT02710331|"~     The overarching goal of this study is to characterize the effects of ethanol and~     cannabinoids on simulated driving and related cognition.~   "
26499|NCT02710318|"~     Immunization is one of the most effective public health interventions. Yet, nationally~     coverage has consistently fallen short of national goals, and has remained for the most part~     stagnant. The continued presence of vaccine-preventable diseases poses a threat to public~     health. In addition to needed improvement of immunization coverage for the general~     pediatric/adolescent population, some children with chronic medical conditions need specific~     additional immunizations, yet many fail to receive them.~      Immunization reminders for providers in the electronic health record (EHR) are a type of~     clinical decision support (CDS) that can reduce missed immunization opportunities. One~     limitation of these reminders is that they generally depend only on data local to the EHR,~     which can be incomplete due to record scatter, leading to inaccurate alerts. An Immunization~     Information System (IIS), also known as an immunization registry, is a population-based~     system that collects immunization data primarily for children and adolescents from providers~     at a regional or state level.~      The investigators seek to couple bidirectional exchange of IIS immunization information and~     forecasting tools with patient level medical history from the EHR to deliver accurate,~     patient-specific EHR immunization reminders.~   "
26500|NCT02710305|"~     hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and~     considered to be the traditional and the gold standard in the assessment of the patency of~     the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study~     reported the patients complained of moderate to severe pain during the procedure. It is~     reported that some patients undergoing hysterosalpingography was more stressful and anxiety~     and effect on pain scores.~   "
26501|NCT02710292|"~     The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE)~     for Investigator-rated successful lens centration in Japanese population.~   "
26513|NCT02710136|"~     This research is being done to look at the body's response to cockroach extract, an~     allergen, when sprayed into the nose. The spraying of the cockroach extract into the~     participant's nose is called Nasal Allergen Challenge (NAC). The purpose of this study is to~     evaluate the safety and tolerability of a intranasal cockroach extract given to participants~     with asthma.~   "
26594|NCT02709083|"~     This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in~     treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in~     which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature~     blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
26502|NCT02710279|"~     Suicide is a major health problem that causes annually a million death worldwild. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition and stressful condition. We hypothesized that the sensitivity to~     social exclusion may represent a core component of the suicidal vulnerability Recent~     evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore,~     social stressors are particulary strong and specific triggers of inflammatory response.~      To sum up, patients carrying a suicidal vulnerability are expected to present greater~     responses to social rejection in terms of inflammatory activity and psychological pain.~      The aim of the study is to evaluate the psychological and inflammatory responses to a social~     stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the~     moderating effect of childhood abuse, attachment, trait rejection sensitivity and social~     isolation.~      In the second part of the study, we will also investigate the prospective association~     between inflammatory responses induces by laboratory paradigms of social rejection and the~     occurrence of social distress, suicidal ideation and psychological pain in response to~     social exclusion events in real life (using ecological momentary assessment).~   "
26503|NCT02710266|"~     Liver resection have been a primary treatment option for lesions found in the liver. With~     improvements in surgical technique and perioperative patient management, morbidity and~     mortality related to liver resection have been greatly reduced. However, many patients with~     hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease~     plays an important role in decision making of resection extent. Therefore, liver failure and~     decreased liver function following liver resection still remains to be an critical issue.~      Postresection liver failure is generally defined by serum total bilirubin greater than~     3mg/dL and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of~     postresection liver failure is not yet well known. However, sepsis after liver resection,~     small-for-size syndrome (SFSS), and ischemia/reperfusion injury are known to have important~     roles in persistant liver injury after resection.~      After a liver resection, kupffer cells are drastically decreased and innate immunity of the~     patient is also damaged. This process causes the patient to be vulnerable to infection. In~     addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered~     and liver regeneration is affected.~      Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of~     hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute~     inflammatory cytokines.~      Recent studies have reported on many promising effects of the synthetic protease inhibitor,~     such as Gabexate mesilate. These include antioxidant effect, inhibition of acute~     inflammatory cytokine reaction, and anticoagulatory property. Based on these effects,~     synthetic protease inhibitor have gained attention in the role of hepatocyte protection~     after liver resection.~      Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on~     ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in~     surgical technique and equipment, many surgeons now perform liver resection without Pringle~     maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in~     the liver resection performed without Pringle maneuver.~   "
26504|NCT02710253|"~     The goal of this clinical research study is to learn if using radiation therapy can help to~     control the cancer after the disease has gotten worse after receiving immunotherapy.~   "
26505|NCT02710240|"~     A specific aim is to determine if Indocyanine Green (ICG) administered pre-operatively, then~     imaged intraoperatively using our camera will aid in the identification of suspected central~     nervous system (CNS) tumors. A secondary aim is to understand if the use of ICG during~     surgery correlates to MR imaging findings including elevated Cho/Cr ratio, rCBV, Ktrans and~     contrast enhancement.~   "
26506|NCT02710227|"~     Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep~     quality, sleep timing parameters and circadian preference were evaluated using the~     Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite~     Scale for Morningness (CSM) respectively~   "
26507|NCT02710214|"~     Duavee is a hormone receptor modulator that has been approved for the treatment of~     menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind,~     placebo controlled pilot study, is to determine whether this medication alleviates~     menopausal symptoms in women with MS. The investigators will secondarily determine whether~     addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering~     worsening inflammation.~   "
26508|NCT02710201|"~     Objective: Physical activity confers numerous health benefits, yet few adults meet~     recommended physical activity guidelines. The impact of brief messages providing feedback on~     physical activity was tested in this study. Methods: Young adults were randomly assigned to~     one of three conditions: (1) feedback on how active others were, (2) feedback on how active~     others were plus a message of approval or disapproval depending on whether the participant~     was more or less active than average, or (3) no feedback (control condition). Participants~     used pedometers for eight weekdays and recorded their step counts each evening. The group~     receiving feedback on how active others were got information about the average number of~     steps taken by group members the previous day. The group that also received approval or~     disapproval received feedback about the group average, as well as a sad face if the~     participant was below the average or a happy face if the participant was above the average.~     The control group received no feedback throughout the study. Impacts of these feedback~     messages were compared on number of steps taken during the study.~   "
26509|NCT02710188|"~     The purpose of this study is to find a modified release oral tablet formulation for this~     drug, which will be safe and well tolerated.~   "
26510|NCT02710175|"~     Infertility is defined as the inability of a couple to achieve pregnancy over an average~     period of one year (in women under 35 years of age) or 6 months (in women above 35 years of~     age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or~     both. It can be either primary or secondary.~      Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy~     as well as fertility, regardless of the presence of disease in women of reproductive age. In~     particular, hypothyroid women are at an increased risk of menstrual disorders and~     infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and~     abnormal release of gonadotropin-releasing hormone.~      The prevalence of subclinical hypothyroidism characterized by aberrant high serum~     thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile~     women are reported to be approximately 20% and it is a primary cause of subfertility.~      Indeed, average TSH levels in infertile women were reportedly higher than those in normal~     fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve~     in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical~     hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve~     fertility to successful pregnancy.~      This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers~     et al., 2013).~      On the other hand, female fecundity decreases with increasing age, primarily because of~     decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging~     to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and~     differentiation. It is produced by the granulosa cells from pre-antral and small antral~     follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely~     correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker~     of ovarian age in women of reproductive age.~      Expectedly, ovarian function may be affected by impaired thyroid function, although this~     association has not been elucidated. In this study, we will evaluate the relationship~     between thyroid function and AMH levels by comparing them in infertile patients and healthy~     fertile women.~   "
26746|NCT02707107|"~     Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses~     of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.~   "
26514|NCT02710123|"~     Adolescents with concussion will be randomly assigned to a treatment group where they will~     receive sub-threshold exercise, or assigned to a placebo group where they will receive~     structured stretching exercises. Both groups will receive standard medical coverage with~     regular clinic visits. All participants will record symptoms daily on a dedicated web site.~     All participants will be evaluated at time 1 with (1) structured physical exam, and (2)~     structured exercise stress test which is terminated when there is symptom exacerbation. The~     primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic~     for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of~     symptoms, and (3) confirmed by a physician based on a structured physical exam.~   "
26515|NCT02710110|"~     Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are~     hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of~     fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4%~     of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions~     are currently lacking. Although the use of exercise in ALS is controversial, recent evidence~     suggests that mild to moderate intensity exercise applied early in the disease slows disease~     progression, improves motor function, preserves motor neuron number, reduces muscle~     hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human~     clinical trials.~      This research study is designed to determine the impact of respiratory strength training on~     breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis~     (ALS).~   "
26516|NCT02710097|"~     The overarching goal of this study is to characterize the effects of ethanol and~     cannabinoids on simulated driving and related cognition.~   "
26517|NCT02710084|"~     This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin~     as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a~     randomized, placebo-controlled design for 12 weeks (phase 1), followed by an open-label~     extension for 12 weeks (phase 2). The purpose is to evaluate the effect of intranasal~     oxytocin on impairments in attention, social memory, socialization, language, and repetitive~     behaviors.~   "
26518|NCT02710071|"~     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.~     They often develop high blood pressure. We are not sure what drug is best to treat the high~     blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ)~     for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24~     hour monitoring.~   "
26519|NCT02710058|"~     The investigators are conducting a study entitled 'Experience of Arab American Women with~     Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's~     experience with breast cancer.~   "
26520|NCT02710045|"~     The purpose of this study is to investigate for the broad immunological effects of~     administering measles vaccine (MV) and diphtheria-tetanus-whole cell pertussis vaccine (DTP)~     to 9 month old Gambian infants, either alone or together. Effects on vaccine-specific immune~     responses, innate immunity, and immune memory were studied. The hypothesis is that when MV~     and DTP are given together there will be more inflammation and this will interfere with~     generation of immunity to the vaccine and to other non-vaccine related stimuli.~   "
26521|NCT02710032|"~     The investigators propose a social network-based PrEP adherence intervention as part of a~     comprehensive, context-specific approach to HIV prevention for TW in Lima, Peru. In order to~     be effective, PrEP-based prevention strategies need to address not only biological efficacy,~     but also individual behavioral decision-making processes, interpersonal partnership contexts~     of risk, peer norms of sexual behavior and PrEP adherence, and structural access to~     prevention technologies. Using a health promotion behavioral model that combines Social~     Action Theory with social network theories of information dissemination and collective~     behavior change, the investigators propose to develop and refine a network-based~     intervention that promotes PrEP adherence in the existing social networks of TW. Formative~     research will outline individual, partner-level, and network-based contexts of sexual risk~     behavior, patterns of social network interactions, anticipated adoption and use of new~     prevention technologies, and optimal content for a PrEP adherence intervention. Findings~     will be used to define the elements of a prevention intervention using social networks of TW~     and social media technologies to generate, implement, and reinforce social norms of PrEP~     adherence and risk behavior reduction for TW.~   "
26522|NCT02710019|"~     The purpose of this study is to determine whether the Back to Reality series video games -~     Harry's Journey, Harry's Journal, and Pathways to care map - are effective at educating~     homeless and street involved youth, registered at the Youth Services Good Shepherd Hamilton,~     about the emotional, social, and psychiatric sequel of problematic underage substance use.~     The objectives of the video games are to promote early detection and awareness of mental~     health and substance use problems among youth.~   "
26523|NCT02710006|"~     The purpose of this trial is to evaluate the feasibility and reliability of automatic volume~     calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and~     uterine cavity will be acquired during three-dimensional ultrasonography and~     sonohysterography. After that independent observers will measure offline the uterine cavity~     volume using automatic volume calculation using SonoAVC general software, and VOCAL~     software.~   "
26524|NCT02709993|"~     The purpose of this study is to determine the safety and efficacy of Tumor Associated~     Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of hematologic~     malignancies.~   "
26525|NCT02709980|"~     The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a~     non-medication treatment, in recent TBI patients compared to a sleep education control~     intervention. Patients will participate in CBT-I treatment (or sleep education treatment)~     weekly for six weeks, and will have a 3-months follow-up visit in order to examine the~     efficacy and time course of treatment. In addition, participants will complete several~     self-report questionnaires in order to examine sleep and neuropsychiatric symptoms~     throughout treatment.~   "
26557|NCT02709564|"~     The aim of the study is to compare the effectiveness of sublingual administered~     prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before~     myomectomy to decrease blood loss during and after the operation.~   "
26558|NCT02709551|"~     Aim of the study is the evaluation of the effects (psychological and physiological) of an~     hrv-biofeedback training, a mindfulness training and a combination of both training methods~     for stress reduction.~   "
26526|NCT02709967|"~     Background Adolescent pregnancies carry risks to the young mothers and the baby. Keeping~     girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young~     rural girls have given birth by the age of 18 years, and the pregnancy rates are~     particularly high among girls who are out-of-school. Approximately 50% of girls never enroll~     in secondary school. Widespread myths and negative social norms are barriers to adolescent~     girls using modern contraceptives, thus contributing to high rates of early pregnancy.~     However, there is little robust research from Africa on how sexual and reproductive health~     programmes can be delivered in a way that actually affects early marriage and pregnancy~     rates.~      Purpose To measure the effect on early childbearing rates in a rural Zambian context of (1)~     economic support to girls and their families, and (2) combining economic support with a~     community intervention to enhance knowledge about sexual and reproductive health and~     supportive community norms~      Design Cluster randomized controlled trial with three arms with clusters being rural basic~     schools (With grades 1-9) with surrounding communities.~      Study population The participant population will be girls enrolled in grade 7 in January in~     2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka,~     Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.~      Study size Approximately 5000 girls and 157 clusters, that is 1000 girls and 31 clusters in~     the control arm and 2000 girls and 63 clusters in each of the intervention arms. The~     rationale for having different numbers of clusters is that we expect larger differences~     between each of the intervention arms and the control arm than between the two intervention~     arms themselves.~      Intervention One intervention arm will be offered economic support in the form of monthly~     cash transfers to the participating girl and her parents and payment of school fees in 2017~     and 2018 if the girl attends junior secondary school. The second intervention arm will be~     offered the same economic support combined with a community component comprising community~     meetings about the value of education for adolescent girls and the risks related to early~     childbearing, and a youth club for girls and boys (both in- and out-of-school).~   "
26527|NCT02709954|"~     The overarching goal of this study is to characterize the effects of ethanol and~     cannabinoids on simulated driving and related cognition.~   "
26528|NCT02709941|"~     The purpose of the current study is to investigate the effects of a novel breathing~     training, called inspiratory muscle strength training (IMST), on sleep patterns, breathing~     and blood pressure for patients diagnosed with mild, moderate and severe sleep apnea.~   "
26529|NCT02709928|"~     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-0714 in healthy adult and elderly subjects~   "
26530|NCT02709915|"~     This study is undertaken to explore in patients with uncontrolled T2D treated with insulin,~     whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG~     expression and will be more effective for weight loss and for achieving glycemic control and~     reduction of total daily insulin dose compared to an isocaloric diet with 6 small meals~     distributed evenly along the day~   "
26531|NCT02709902|"~     Bioequivalence with Clinical Endpoints.~   "
26532|NCT02709889|"~     To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific~     delta-like protein 3-expressing advanced solid tumors.~   "
26533|NCT02709876|"~     A single arm, single center trial to evaluate the safety and efficacy of autologous purified~     populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs)~     through a 48 month follow up period.~   "
26534|NCT02709863|"~     This study will compare the effects of sevoflurane, desflurane and total intravenous~     anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal~     transsphenoidal surgery of pituitary gland. Participants will be divided into three equal~     groups. The first group will receive sevoflurane, second grup will receive desflurane and~     third grup will receive total intravenous anaesthesia. Investigators are also going to~     evaluate blood gas analysis.~   "
26535|NCT02709850|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated~     triglycerides and subjects with familial hypercholesterolemia.~   "
26536|NCT02709837|"~     This project aims at assessing~        -  the impact of heat treatment on the bioavailability of meat carnosine and amino acids,~        -  the interaction between masticatory efficiency and heat treatment of meat on the~          bioavailability of carnosine and amino acids~        -  the effect of dietary calcium on tomato lycopene bioavailability.~   "
26537|NCT02709824|"~     Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.~      A prospective, cross-over, randomized clinical trial will be carried out in triple blind to~     compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without~     anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the~     study includes two sequential stages: in the first phase, the immediate objective and~     subjective evaluation of dental discoloration by spectroscopic and questionnaire-based~     analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A~     wash-out period between the cycles of 21 days will be performed.~      In the second phase, a long-term (after 6 months) subjective evaluation of dental~     discoloration will be obtained by means of clinical photograph visual analysis and new~     questionnaires.~   "
26538|NCT02709811|"~     Electrochemotherapy (ECT) is a non-thermal tumour ablation modality. It consists of the~     local potentiation, by means of local reversible electroporation of tumour tissues, of the~     antitumor activity of non-permeant or poorly permeant anticancer drugs already possessing~     intrinsic cytotoxicity. ECT has proved to be effective in the treatment of various cutaneous~     tumour nodules of any origin. Mostly ECT is offered to patients in case of multiple~     cutaneous metastases, when they cannot be excised, due to their number or localization. This~     study investigate the application of ECT in the treatment of liver metastases from~     colorectal adenocarcinoma, for which other thermal cytoreductive methods would be risky~     compared to the supposed expected clinical benefits.~   "
26539|NCT02709798|"~     The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could~     reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac~     magnetic resonance imaging) in patients with STEMI after primary PCI~   "
26540|NCT02709785|"~     The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced~     Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse~     and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical~     to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium~     chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque~     and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste~     perception, malodor and calculus.~   "
26541|NCT02709772|"~     10 Clinics within Stanford Health Care are randomized to receive or not receive provider~     alerts for 5 commonly overused tests and treatments.~   "
26559|NCT02709538|"~     To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS~     formulations for the treatment of perennial allergic rhinitis (patients 12 years of age and~     older)~   "
26542|NCT02709759|"~     The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial~     randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV~     primary care clinics (one in the Northeast and one in the South). The first study factor~     will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed~     personalized normative and HIV-specific feedback. The second factor compares an interactive~     text messaging (ITM) intervention vs. no text messaging. The final factor compares~     intervention of low intensity and duration (two sessions over 1 month) to extended~     intervention (EI) entailing 5 sessions over 9 months.~   "
26543|NCT02709746|"~     Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive~     symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical~     Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).~   "
26544|NCT02709733|"~     The loss of motivation has emerged as a critical symptom in schizophrenia that is~     consistently linked to functional disability for affected individuals. Despite advances in~     treatment, there have not emerged any effective treatments for this loss of motivation,~     which ultimately hinders our ability to promote recovery for individuals with schizophrenia.~     To address this critical unmet therapeutic need, this study aims to investigate a novel~     computerized motivation rehabilitation program using virtual reality to treat motivation~     loss in schizophrenia.~   "
26545|NCT02709720|"~     Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as~     induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung~     cancer (NSCLC) locally advanced unresectable~   "
26546|NCT02709707|"~     Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users~   "
26547|NCT02709694|"~     In patients with Crohn's Disease, symptoms of inflammatory back pain (IBP) precede changes~     on plain X-rays by years, and MRI changes of axial inflammation precede development of X-ray~     changes. Sacroiliitis on MRI without x-ray changes (i.e.Non radiographic SpA) is a valid~     diagnostic criterion for Spondyloarthritis (SpA) and leads to earlier diagnosis of SpA in~     patients with IBP. It is unclear when MRI changes occur, and if they precede clinical~     symptoms of IBP. There are reports of asymptomatic sacroiliitis noted on MRI in Crohn's~     patients. This is important, as MRI evidence of inflammation may be the first sign of~     incipient SpA. Inflammation in other regions of the axial skeleton in SpA patients has also~     been documented, but its significance is unknown. The prospect of undiagnosed and untreated~     inflammation is concerning, as it can lead to significant morbidity. Moreover, relationship~     between MRI evidence of axial inflammation-likely a proxy for systemic inflammation- and~     patient reported outcomes (e.g. ASDAS-CRP= Ankylosing Spondylitis Disease Activity Score- C~     reactive protein, BASDAI= Bath Ankylosing Spondylitis Disease Activity Index, SF-12 = Short~     Form- 12, HBI= Hervey Bradshaw Index and PROMIS-29= Patient Reported Outcome Measurement~     Information System-29), has not been reported. Recent unpublished data from Dr. Longman's~     lab (collaborator) suggest a distinct intestinal dysbiosis in Crohn's associated SpA. But~     relationship between this microbiome and MRI changes is yet to be determined.~      Identifying inflammation earlier on MRI- in the absence of clinical symptoms will provide an~     opportunity to intervene early with available therapies, such as- biologics etc.~     Asymptomatic MRI changes could be a marker of underlying systemic inflammation- which is a~     risk factor for poor outcomes in Crohn's associated SpA. Studying association between whole~     spine MRI changes with patient reported outcomes) may facilitate informed clinical decision~     making to initiate targeted therapy to prevent progression of structural damage.~     Understanding microbial dysregulation in this population, and correlation with MRI changes,~     could lead to development of therapy targeted to restore intestinal symbiosis.~   "
26548|NCT02709681|"~     This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32~     treatment centers across Italy. The aim of this study will be to report the Italian~     experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the~     benefits and safety of this intervention for the prevention and management of a wide range~     of clinical morbidities~   "
26549|NCT02709668|"~     A randomized double-blind placebo controlled study of reduced B vitamins in patients with~     major depression who were positive for one or both of the common MTHFR polymorphisms was~     conducted between 8/1/2014 and 4/3/2015. Homocysteine levels and MADRS scores were used as~     primary measures. The study was designed to test safety and efficacy of reduced B vitamins~     in MDD associated with MTHFR. This study examines the data from the trial to see effects,~     effect sizes, and further, if demographic factors and other patient characteristics~     correlated with findings.~   "
26550|NCT02709655|"~     Investigation of the efficacy and safety of a new potential treatment of Major depressive~     disorder (MDD) in paediatric patients (age 7 to 11 years)~   "
26551|NCT02709642|"~     The purpose of this study is to determine if a financial deposit contract is a successful~     method of helping people to maintain their weight loss. A deposit contract is an agreement~     in which participants put their own money at risk, with the goal of earning it back by~     achieving a goal, in this case maintaining prior weight loss. The study will also evaluate~     the interventions using survey research to assess the feasibility and acceptability of the~     interventions.~   "
26552|NCT02709629|"~     The current study examines the efficiency of a home-based computerized cognitive training~     (CT) intervention targeting older adults with diabetes.The primary aim of the study is to~     evaluate the effects of CCT on cognitive and disease management in non-demented older~     diabetes adults. Investigators will also evaluate the effect of the intervention on a range~     of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small~     sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.~   "
26553|NCT02709616|"~     Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is~     designed to perform a personalized clinical trial by first analyzing the expression of tumor~     associated antigens in patients with newly diagnosed glioblastoma and then immunizing the~     patients with personalized DC-based cellular vaccine. In addition, allogeneic peripheral~     blood mononuclear cells (PBMCs) will be used as cellular vehicle for immunization. Safety~     and efficacy will be observed in the study.~   "
26554|NCT02709603|"~     Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to~     relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an~     antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to~     relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor~     gynecological procedures. So the efficacy of hyoscine use are still controversial and no~     previous studies investigated its efficacy for pain relief in HSG procedure.~   "
26555|NCT02709590|"~     The aim of our study is to determine the efficacy of oral diclofenac potassium combined with~     lidocaine cream on the pain scores during HSG.~   "
26556|NCT02709577|"~     The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier~     Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.~   "
26560|NCT02709525|"~     The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in~     human dental sockets.~   "
26562|NCT02709499|"~     Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and~     surgical procedures to treat these disorders have grown dramatically in recent years. Since~     the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis,~     many techniques have been used to improve the outcome of surgery and reduce their side~     effects. The low-level laser therapy (LBP) has been widely used in clinical practice for~     pain relief purposes, reducing inflammation and stimulating tissue healing. However, the~     effect of this therapy has been little elucidated in patients with cardiac disease. The~     objective of this study is to evaluate the effect of low level laser therapy on the~     inflammatory profile and cardiac tissue healing markers of patients in the postoperative~     period of CABG surgery.~   "
26563|NCT02709486|"~     Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth~     factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important~     breakthrough in the treatment of chronic pain and is under clinical investigation for the~     treatment of pain associated with osteoarthritis or other chronic pain conditions.~      The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg~     and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in~     subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide~     efficacy benefits with a favorable safety profile when administered intravenously in~     previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy~     benefit over the 2.5 mg dose based on data from previous studies.~   "
26564|NCT02709473|"~     Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway~     in patients especially at risk of aspiration. Propofol and rocuronium are generally used~     agents for RSI. However, the difficult airway scenarios are always valid for these patients,~     even without predictive signs of difficult airway. Therefore, it is important to decrease~     the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction~     with the aid of a reversal agent in case of difficult airway. The short acting opioids such~     as remifentanil may be helpful to reduce the dose of rocuronium in RSI.~   "
26565|NCT02709460|"~     Laparoscopic hysterectomy is associated with complications in form of infections and~     subsequently dehiscence of the vault. This is a serious complication. The infection may be~     related to the frequently observed postoperative hematoma following traditional laparoscopic~     hysterectomy where the uterine artery is coagulated and divided at the cervical entry into~     the uterus.~      By coagulation of the uterine artery laterally close to the internal iliac artery this~     problem may be eliminated due to the much less bleeding observed during this procedure.~   "
26566|NCT02709447|"~     Girls in the juvenile justice system are at high risk for dating violence exposure as well~     as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of~     negative outcomes associated with dating violence, no evidence-based preventive~     interventions exist for juvenile justice girls. This study will advance scientific knowledge~     by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing~     dating violence, delinquency and sexual risk outcomes for a broad range of court-involved,~     non-incarcerated girls.~   "
26567|NCT02709434|"~     Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease~     (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue~     may be easily explained by other symptoms or tests which show that the disease is active.~     For example patients may be anaemic (have a low blood count) which can in itself lead to a~     feeling of being tired all the time. Treatment of the disease can make some of these~     patients feel less fatigued.~      However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not~     active disease) report fatigue. This can have far-reaching implications for patients in~     their everyday lives, with issues around work or school, close relationships, travel and~     leisure being profoundly affected. The CCUK funded research on fatigue and IBD, led by~     Professor Christine Norton and Wladzia Czuber-Dochan at King's College London, has~     identified fatigue as being a significant issue facing patients and has also highlighted~     that few doctors offer help and support beyond treating the disease itself when active. This~     is partly because fatigue itself has been difficult to measure and so any study designed to~     treat fatigue would be limited by being unable to quantify any improvement in a meaningful~     way.~      Fortunately the King's College group have developed a 'fatigue score' which is a simple~     questionnaire that is able to quantify the severity of fatigue. The aim of our study is to~     assess the effect of a structured support and educational programme on the levels of fatigue~     in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary~     component of our study is to see if there are any associations between fatigue levels and~     disease activity or other parameters such as quality of life, anxiety or symptoms of~     overlapping irritable bowel syndrome.~      Patients will be approached in the out-patient or telephone clinics and the study will be~     explained with written information and any questions will be answered. If they agree to~     being involved they will be asked to complete the fatigue and a number of other~     questionnaires in addition to having the standard assessment of symptoms, blood tests and a~     stool specimen. Patients with active disease will be excluded from the subsequent group~     interventions but the data they have provided to this point will still be helpful in our~     understanding of fatigue in IBD. Patients identified as being in remission following the~     initial assessments will be offered the opportunity to be involved in the next stage of the~     study. The stool samples will also be analysed for the microbiome ie which bacteria are~     present as some studies suggest that patients with IBD may have a reduced diversity of~     bacteria in their intestines.~      Half of this group will be randomised to active intervention and half will act as a control~     group for the rest of the study. The active intervention will involve completion of activity~     diaries over the following two weeks and then analysis of the diaries and agreement on~     behaviour changes designed to help fatigue. This will be supported by written information~     and three, monthly small group sessions to reinforce and support these changes.~      At the end of the study all patients will again complete the fatigue and quality of life~     questionnaires and have their disease activity assessed by symptom scores, blood and stool~     tests. The baseline results and the final results will be analysed to see if there is any~     improvement in fatigue in the group undergoing the programme of support and behaviour~     change.~      This is only a small pilot study but if it demonstrates that the intervention is feasible~     and may help with fatigue then a larger study will be performed to try and confirm our~     initial findings.~      Our ultimate aim is to find a simple intervention to empower patients to deal with the~     difficult task of living with IBD and the fatigue that this can bring.~   "
26568|NCT02709421|"~     Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most~     frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been~     proved to be effective in reducing the incidence of PEP. It has been widely used to prevent~     PEP in patients, especially those with potentially high risks of PEP. However, rectal~     indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients~     receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients~     receiving rectal indomethacin remains unclear. The aim of the study was to identify~     potential risk factors in high-risk patients whose received administration of prophylactic~     rectal indomethacin after ERCP.~   "
26569|NCT02709408|"~     Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important~     challenge because of the rapid worldwide spread of mechanisms conferring resistance to~     multiple drugs. The most recent and worrying problem is the emergence and spread of~     carbapenemases. Additionally, carbapenem-resistance is known to be very frequent among~     Acinetobacter baumannii isolates for many years. Overall, the therapeutic options available~     against carbapenem-resistant Enterobacteriaceae (CRE) and A. baumannii (CRAB) are very~     limited. The best available treatment (BAT) against CRE is unknown, which is a challenge for~     therapeutic decisions and also for the design of randomized trials with new drugs. The~     generic objectives of EURECA are to obtain high‐quality observational data to inform the~     design of randomized controlled trials for complicated intraabdominal infections, pneumonia,~     complicated urinary tract infections and bloodstream infections due to Carbapenem-resistant~     Enterobacteriaceae (CRE) and carbapenem-resistant Acinetobater baumannii, and to provide~     cohort data that could eventually be used as historical controls for future comparisons with~     new drugs targeting CRE. This will be achieved by a prospective, multinational cohort study~     of patients with targeted infections due to CRE and CRAB, and by matched~     case-control-control studies.~   "
26570|NCT02709395|"~     This study is designed as an open, prospective, single arm, multicenter study in order to~     investigate patient satisfaction, perception and compliance for the novel Navina Smart, a~     transanal irrigation (TAI) system. Approximately 30 male and female subjects who are~     currently practicing TAI, will be followed during a 4-week period of use of Navina Smart.~     Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and~     TAI frequency will be collected via patient reported outcome (PRO) questionnaires.~   "
26571|NCT02709382|"~     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male~     and female subjects with normal and impaired renal function. The study will be composed of~     five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients)~     renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their~     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).~   "
26595|NCT02709070|"~     There is little evidence showed that adjuvant therapy had been shown to extend the survival~     of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We~     investigated whether injections of highly-purified Cytotoxic T lymphocytes prolongs~     recurrence-free survival of patients after resection for HCC.~   "
26572|NCT02709369|"~     The purpose of this study is to explore the functional and physiological effects associated~     with the use of High-resolution, relational, resonance-based, electroencephalic mirroring~     (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and~     neuropsychological disorders. This is a non-randomized, open label, and unblinded~     before-and-after trial, evaluating the effect of HIRREM on an objective, physiological~     common denominator (heart rate variability, HRV), across a variety of relevant conditions,~     as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data~     for investigation in future proposals.~   "
26573|NCT02709356|"~     Evaluate and compare the changes in brain ketone and glucose uptake after taking two~     different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with~     Alzheimer's disease and a control group.~   "
26574|NCT02709343|"~     This study is designed for lung transplant patients who have developed chronic lung~     allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of~     allogeneic, bone-marrow-derived MSCs (2*10^6 cells/kg/dose) or matching placebo over a~     period of 2 weeks with a 12 month follow up.~   "
26575|NCT02709330|"~     This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial~     utilizing a historical control group. Participants will receive a Lunasin regimen and will~     be asked to register for an account of PatientsLikeMe website, where after the initial~     in-clinic visit, they will be asked to enter specific data.~   "
26576|NCT02709317|"~     Veterans who are taking prescription opioids for chronic pain and are engaging in risky~     drinking are at heightened risk for drug interactions, including overdose and other negative~     effects, particularly if they are also using benzodiazepines. In this application, the~     investigators propose to test an integrated prevention intervention, designed to reduce~     rates of risky drinking in veterans receiving prescription opioids to treat their chronic~     pain. This adaptive, patient-centered intervention provides integrated clinical assessment,~     brief intervention, monitoring, and extended prevention services delivered through a~     combination of clinical visits, telephone calls, and text messages. The investigators~     propose to conduct a study in which veterans (N=300) who are on daily doses of prescription~     opioids and screen positive for risky alcohol use will be randomized to receive 12 months of~     an adaptive integrated prevention intervention (IPI) or to standard care (SC), which~     consists of a Brief Intervention (BI) with 2 follow-up contacts. Potential participants will~     be veterans at the Philadelphia VA, and surrounding areas, or the Pittsburgh VA who, based~     on pharmacy records, are using opioids daily to treat chronic pain. An initial evaluation~     will identify individuals who also engage in risky alcohol use based on NIAAA-recommended~     guidelines and meet other inclusion criteria to be enrolled in the study. The evaluation~     will also identify the use of other medications (e.g., benzodiazepines) that could interact~     negatively with opioid use. For veterans randomized to the IPI condition, a BI is first~     provided to reduce alcohol to non-hazardous levels and the effects are monitored for one~     month. Veterans who reduce alcohol use to non-hazardous levels during this one-month period~     continue in a monitoring track, consisting of tailored text messages and brief monthly~     telephone contacts. Veterans who continue to drink at risky levels are instead placed in a~     track that provides tailored text messages and more frequent telephone calls. In addition to~     monitoring, these calls provide further prevention/BI services to help the veteran reduce~     alcohol use to non-hazardous levels. Key components of these services are motivational~     enhancement and development of more effective ways to cope with stress and other triggers~     for risky alcohol use. All participants will be followed up at 3, 6, 9, 12 and 18 months~     after baseline. The primary outcome at each follow-up point will be a dichotomous measure of~     any risky drinking since the prior follow-up (yes/no). Secondary outcomes will include~     self-reported frequency of heavy drinking, biological measures of alcohol use, other drug~     use as determined by urine toxicology tests, opioid overdoses, and ratings of depression and~     pain. Repeated measures analyses will compare the IPI and SC conditions on primary and~     secondary outcomes assessed across an 18-month follow-up. Analyses will also test~     hypothesized moderation and mediation effects.~   "
26577|NCT02709304|"~     This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease~     pain and discomfort associate with Foley catheters upon awakening from general anesthesia in~     the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial~     colony counts from urine obtained from the surgical patients after insertion of the Foley~     catheter prior to prophylactic antimicrobial administration.~   "
26578|NCT02709291|"~     Early childhood disruptive behavior problems lead to significant costs to families and~     society, but can be reduced with behavioral parent training interventions. To increase the~     public health impact of these interventions, their feasibility, accessibility, and~     acceptability in high-need, underserved communities must be ensured. This pilot project will~     systematically adapt and pilot-test the delivery model of an existing effective parent~     training intervention for implementation in rural Appalachia, a region with many documented~     health disparities, high levels of poverty, and shortages of mental health providers.~     Community health workers in 5 rural Appalachian counties will be trained to deliver a~     behavioral parent training intervention. Each worker will deliver the intervention to 4~     parent-child dyads.~   "
26579|NCT02709278|"~     TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge~     administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will~     also look to evaluate and compare the amount of BCG recovered from the lungs and from the~     skin, following challenge by either the aerosol or the intradermal route.~   "
26580|NCT02709265|"~     This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing~     healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI~     Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12~     mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a~     single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and~     urine pharmacokinetics in spontaneously breathing healthy volunteers.~   "
26581|NCT02709252|"~     Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one~     of the best parameter to predict fluid responsiveness in patients under general anaesthesia.~     Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the~     pneumoperitoneum has been recently seen suggested as a limitation to their interpretation.~     The aim of this observational study is to compare changes in ΔPP and PVI related to~     autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in~     patients undergoing elective surgery.~   "
26582|NCT02709239|"~     The purpose of this study is to learn how much DHA to give to mothers in order to provide~     enough to the baby. Researchers will also learn if there are differences in development of~     the baby up to 12 months after birth.~   "
26596|NCT02709057|"~     The aim of the study is to compare the effect of lifestyle intervention (diet and physical~     activity) by applying modern approaches to lifestyle changes on the prevention of incident~     T2DM and the worsening of hyperglycemia in people with high number of T2DM risk alleles and~     in people with low number of T2DM risk alleles compared to corresponding control groups.~   "
26597|NCT02709044|"~     The aim of this study is to establish the influence of early administration of a bolus of~     intravascular fluid in patients with a diagnosis of acute pancreatitis on the course and~     outcome of disease.~   "
26583|NCT02709226|"~     Background:~      A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and~     radiation therapy. However, most people s tumors come back after therapy. When the tumor~     grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat~     radiation therapy or re-irradiation, is an option for treating these tumors when they~     regrow.~      Objective:~      To find out the safety and highest tolerated dose of re-irradiation for people who have~     recurrent glioblastoma.~      Eligibility:~      People ages 18 50 who have glioblastoma that has been treated with radiation but has~     regrown.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      MRI of the brain: They will lie in a machine that takes pictures of the brain.~      Participants will have baseline tests before they start therapy. These will include:~      Blood tests~      Neuropsychological tests: These test things like memory, attention, and thinking.~      Quality of life questionnaire~      Eye and hearing tests~      Participants will get a CT of the brain prior to radiation start in order to plan the~     radiation treatment. Once the plan is completed, they will receive radiation once a day~     Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10~     minutes while they get the treatment.~      Participants will be monitored for side effects.~      After they finish treatment, participants will have visits 1, 2, and 3 months later. Then~     they will have them every 2 months for 3 years. These will include:~      Medical history~      Physical exam~      Blood tests~      MRI of the brain.~      Quality of life questionnaire~      Neuropsychological tests (at some visits)~      After 3 years, participants will be contacted by phone each month.~   "
26584|NCT02709213|"~     The aetiologies of computed tomography-diagnosed acute colitis remain surprisingly unknown.~     Moreover, no diagnostic tool or clinical score allow to quickly determine or at least~     stratify the exact cause of colitis in patients admitted at an Emergency Ward and to direct~     them to the appropriate therapeutic care. The aims of the present study are to describe the~     presentation and aetiologies of acute colitis, and to develop diagnostic methods to guide~     patients admitted for acute colitis to the appropriate therapeutic care, particularly~     colonoscopy.~   "
26585|NCT02709200|"~     This is a prospective study looking at the effects of dexmedetomidine on pacemaker function~     in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass~     (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The~     use of dexmedetomidine will be left up to the discretion of the treating physicians. The~     study will involve only the collection of data regarding the amplitude required to capture~     and specific demographics and intraoperative features including cross clamp time, time on~     CPB, and vasoactive agents that were and are being administered. In addition to these data,~     it will be noted whether dexmedetomdine was used or not and whether it is being administered~     on arrival to the CTICU.~   "
26586|NCT02709187|"~     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate~     the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin~     10mg), a fixed dose combination compared with coadministration of separate constituents in~     healthy adult volunteers~   "
26587|NCT02709174|"~     Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic~     protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification~     tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic~     imaging with radiation exposure.~   "
26588|NCT02709161|"~     The purpose of this study is to determine the clinical efficacy of augmenting~     cognitive-behavioral therapy with real-time functional magnetic resonance imaging~     neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive~     autobiographical memories.~   "
26589|NCT02709148|"~     The purpose of this study is to use an investigational device to record brain activity for~     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The~     goal of the study is better understanding of brain activity in Parkinson's disease and how~     they relate to DBS and pharmacological management, not to bring new devices to market.~   "
26590|NCT02709135|"~     Approximately 8-10 million patients complaining of chest pain present to an Emergency~     Department (ED) annually in the United States. These patients are a challenge to healthcare~     providers, who are tasked with determining whether these symptoms are due to an acute~     coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of~     care for patients with acute chest pain, our group recently validated a risk stratification~     pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on~     higher-risk patients, who are more likely to benefit from testing.While the HEART score has~     been well validated in the ED setting, it has yet to be implemented in a prehospital~     setting. Paramedics are often the first providers to evaluate and begin treating patients~     with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based~     on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI~     (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often~     have difficulty distinguishing high-risk patients from low-risk patients.Thus,~     multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine~     have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT®~     point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the~     feasibility and accuracy of HEART score and POC testing in the prehospital setting the~     investigators propose a quality surveillance study of a limited implementation of the HEART~     score with POC troponin testing.~   "
26591|NCT02709122|"~     The study aims to determine the level of knowledge and skills to recognize and decompression~     of tension pneumothorax~   "
26592|NCT02709109|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in~     saline compared to saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of~     age, homozygous for the F508del-CFTR mutation, and being treated with Orkambi~   "
26593|NCT02709096|"~     This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate~     the comparative reduction of Propionibacterium acnes in-vivo following once daily topical~     administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.~   "
26747|NCT02707094|"~     The purpose of this study is to determine the efficacy of self treatment with the~     Biomodulator device to decrease chronic low back pain (LBP) in active duty service members.~     In addition, the study will track the use of pain medication and the impact of pain on~     symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).~   "
26598|NCT02709031|"~     Cicletanine, which has been approved and launched for hypertension in France and Germany,~     has promise beyond hypertension in critically-unmet needs such as diabetes. It is evident~     from in vitro, animal and human studies that cicletanine's optimal dose in diabetes and~     other challenging, critically-unmet needs is likely to be higher than that for hypertension.~     Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects~     are documented to be potassium loss and sodium loss from thiazide-type activity (one of the~     therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be~     reversed safely by magnesium. This trial explores the ability of magnesium to enhance~     cicletanine safety at higher doses in a trial involving patients with hypertension~     complicated by diabetes.~   "
26599|NCT02709018|"~     This study is being conducted to determine if losartan, an angiotensin receptor blocker~     (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD)~     symptoms. The study is also intended to determine if certain genetic markers are useful in~     predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic~     PTSD ages 18-65 will participate in this study across five sites. Subjects will be assigned~     by chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or~     placebo (which resembles the study drug but has no active ingredients), once a day for 10~     weeks. Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene~     will have a superior response to losartan on PTSD symptoms compared to T carriers.~   "
26600|NCT02709005|"~     This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial~     enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to~     receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary~     objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to~     vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%~     Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.~   "
26601|NCT02708992|"~     This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q~     8-hour schedule) alone and also co administered with a single 1000 mg oral dose of~     azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels~     of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and~     whether there are significant changes in cefixime PK after co-administration. The primary~     pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg~     doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds~     2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg~     doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,~     achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to~     evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen~     of 800~   "
26602|NCT02708979|"~     The high worldwide prevalence of overweight and obesity as well as metabolic and disease~     consequences, are well-documented. The positive energy balance underlying obesity is~     attributable to excess energy intake and/or insufficient energy expenditure. However, it~     seems that the increase in mean body weight can be sufficiently explained by increases in~     mean energy intake. It has been proposed that this overeating is partly caused by increased~     availability of highly processed energy dense, high reward foods. Psychosocial stress and~     sleep insufficiency is pervasive in industrialized societies. A growing body of evidence~     suggests stress to be involved in obesity, although it is unknown whether stress is a cause~     or consequence. Stress affecting dietary intake; skewing intake towards greater consumption~     of highly palatable energy dense foods, also referred to as high reward foods. A causal~     relationship between stress and reward seeking behavior is supported by findings from animal~     studies reporting rewarding behavior by consumption of sweet tasting food in response to a~     stressor.~      Our aim is to investigate differences in purchases of particular food-items in free living~     individuals, during a stressful (upcoming exam) and non-stressful (no upcoming exam) period.~      Hypothesis: Participants will purchase more high reward foods during the pre-exam period,~     compared to the control non-exam period.~   "
26603|NCT02708966|"~     Prediabetes (PD) was defined as an state in which glucose levels are above normal but not~     enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as~     impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c~     (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the~     prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with~     IGT, it is expected that by 2035 this number will increase to 417 million people affected.~     Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:~     increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose~     utilization in various ways and inhibition of glucose uptake in the intestine.~   "
26604|NCT02708953|"~     Headaches have been listed as 1 of the 10 most disabling conditions worldwide. (Stovner et~     al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these~     complaints. (Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best~     approach to the conservative care of this condition has yet to be determined. The primary~     aim of this study is to determine whether individuals with CeHs will respond to a program of~     thoracic spine thrust manipulation in isolation. This may further the current body of~     evidence by offering an alternative, potentially safer approach to the conservative care of~     individuals with this condition. Additionally, results of this study may serve to drive a~     larger scale Randomized Clinical Trial (RCT) by offering information regarding feasibility~     of recruitment of individuals with chronic CeHs as well as timing and dosing of the~     intervention.~   "
26605|NCT02708940|"~     This research project aims to evaluate the feasibility and effectiveness of a new approach~     to tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP~     program participants—patients and therapists--will be consented and enrolled by study staff.~     Study participants will be invited to workgroups specific to their program to discuss the~     usability of Chorus and be asked to complete surveys on demographics, satisfaction,~     self-efficacy, and involvement with Chorus and usability of the tool.~   "
26768|NCT02706821|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover~     human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose.~     The investigators measures changes in diabetes associated parameters, including fasting~     blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.~   "
26606|NCT02708927|"~     In addition to the physical, cognitive and psychological symptoms experienced by individuals~     with Multiple Sclerosis (MS), there is new research which indicates that some individuals~     with MS have a deficit in emotional processing, specifically, facial affect recognition.~     Emotional processing is defined as a central aspect of social cognition. Models of social~     cognition indicate that emotional processing is an essential component of interpersonal~     relationships. The failure to accurately perceive other's emotions has been shown to lead to~     difficulty in social relationships, misinterpreting other's affect, and consequently,~     inappropriate responding.~      However, even though a significant number of individuals with MS have impairments in~     emotional processing, we do not yet have an understanding of how these impairments affect~     the social functioning of individuals with MS, including the impact of these deficits on~     family structure. It is well-known that MS impacts one's social functioning including~     factors such as employment, daily living activities and interpersonal relationships.~     Recently a strong correlation was observed between reduced social participation in MS and~     quality of life. There is evidence to suggest that emotional processing deficits lie at the~     heart of this reduced social participation in persons with MS, leading to decreased social~     functioning and thus reduced quality of life. However, to date, this hypothesis has not been~     tested.~   "
26607|NCT02708914|"~     The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to~     UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure~     receiving hemodialysis.~   "
26608|NCT02708901|"~     The purpose of this study is to assess the effects of a 6-months supplementation with~     probiotic Vivomixx® on inflammatory and gastrointestinal (GI) biomarkers, gastrointestinal~     disturbances, behavioral and developmental profiles, and neurophysiological features in~     preschoolers with Autism Spectrum Disorders (ASD) with or without GI symptoms.~   "
26609|NCT02708888|"~     The aim of this study is to further explore the effects of additional customized trunk~     exercises on clinical and biomechanical gait performance. Despite of the evidence~     demonstrating the importance of trunk control after stroke, studies about the effects of~     trunk rehabilitation on gait performance are inconsistent. The findings of this study might~     lead to new scientific insights in the importance of the trunk during gait rehabilitation in~     people suffering from stroke submitted to a rehabilitation hospital.~   "
26610|NCT02708875|"~     Insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test.~     However, high blood glucose levels during this test may adversely impact on microvascular~     function. Investigators will determine whether a liquid mixed meal challenge (from~     carbohydrate, protein and fat) is a more appropriate test for assessing~     microvascular-derived insulin resistance.~   "
26611|NCT02708862|"~     Four methods of preoxygenation will be compared in healthy volunteers~   "
26612|NCT02708849|"~     The purpose of the study is to characterize the effects of a single, sub-anesthetic dose of~     ketamine in rs-fMRI in healthy subjects. Post-ketamine rs-fMRI data will demonstrate a~     pattern of increased global brain connectivity (GBC) in fronto-temporal cortex.~   "
26613|NCT02708836|"~     Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal~     tube has been shown to favorable with respect to limiting emergence phenomena such as~     coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and~     tachycardia.~      Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher~     ventilation pressures may be required, in those patients who are perceived to be high risk~     for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow~     the anesthesiologist to have little accessibility the airway.~      The aim of this study is to investigate an airway management technique that would allow for~     the benefits of the ETT in terms of a secure airway for the duration of the surgical~     procedure as well the potential for less emergence phenomena seen when emerging with an LMA.~   "
26614|NCT02708823|"~     A common complication after surgery is a temporary state of confusion called postoperative~     delirium (PD) affecting particularly elder patients. In 2014, a computer program for tablet~     computers named Delirium Risk Profile (DRP) was developed at the University Hospital Basel~     to assist preoperative screening. The aim of this study is to generate normative data with~     cognitively healthy participants for the DRP.~   "
26615|NCT02708810|"~     To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at~     a single institution prior to multi-institutional enrollment.~   "
26616|NCT02708797|"~     Migraine with aura (MA) is an independent risk factor for stroke and is associated with~     silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using~     Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA~     patients. Studies with positron emission tomography have demonstrated an activation of brain~     stem areas during migraine attack. An increased density of brain stem grey matter as~     measured on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain~     arteries and arterioles are innervated by ascending tracts from aminergic brainstem nuclei,~     th study hypothesize a negative correlation between the density of brainstem nuclei and the~     efficiency of cerebral autoregulation in MA patients compared with controls.~      Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel~     antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the~     time domain using Transcranial Doppler (TCD) and the Mx method.~      MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD)~     are non-invasive technics and will be performed on the same day.~   "
26617|NCT02708784|"~     The aim of the project is to develop new Magnetic Resonance (MR) imaging techniques for~     better diagnosis and monitoring of patients with muscular disorders.~      Muscle quality in patients with Late Onset Pompe Disease (Acid Maltase Deficiency type 2)~     and in patients with Myotonica Dystrophy will be evaluated, by determining muscle strength~     in relation to muscle size and muscle strength in relations to fat-muscle ratio.~   "
26618|NCT02708771|"~     Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with~     acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase~     in serum albumin~   "
27013|NCT02703623|"~     The goal of this clinical research study is to find out if the combination of ARN-509 (also~     known as JNJ-5602192), abiraterone acetate, and prednisone can be given with either~     ipilimumab or cabazitaxel plus carboplatin to control metastatic CRPC. The safety and~     effectiveness of these drug combinations and their effect on the immune system will also be~     studied.~   "
26619|NCT02708758|"~     There is a lack of international uniformity in the approach to the screening and diagnosis~     of gestational diabetes mellitus (GDM). The new diagnostic criteria by the International~     Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of~     Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the~     lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on~     perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to~     reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.~   "
26620|NCT02708745|"~     The overall goal of this project is to determine whether integrating a novel parent-report~     measure of vaccine hesitancy into pediatric primary care is effective in improving~     acceptance of childhood vaccines among vaccine-hesitant parents.~   "
26621|NCT02708732|"~     This study is a prospective, cross-sectional survey to be administered to real patients in~     remission from DLBCL using a 15-minute postal or online survey. The project is designed to~     describe the impact of DLBCL remission on health utility and quality of life. Data~     collection will occur over a 4-month period.~   "
26622|NCT02708719|"~     The purpose of this study is to determine the minimal important difference (MID) for the~     1-minute-sit-to-stand-test (STST) with an anchor-based method.~   "
26623|NCT02708706|"~     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid~     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for~     treating adhesive capsulitis.~   "
26624|NCT02708693|"~     To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that~     of steroid injection alone using clinical and electrophysiological parameters in patients~     with carpal tunnel syndrome~   "
26625|NCT02708680|"~     The purpose of this study is to determine the safety and tolerability of entinostat used in~     combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer~     (aTNBC). Additionally the purpose of the study is to assess how effective entinostat and~     atezolizumab are in combination in patients with aTNBC.~   "
26626|NCT02708667|"~     Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug~     Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung~     cancer (NSCLC) and its administration has achieved considerable success. However, adverse~     effects inevitably occurred and the most common one was hepatic toxicity, appearing as~     elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the~     investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and~     explore whether there is any biological marker to diagnose this side effect in an early~     stage, which may realize individualized therapy with more efficacy and less side effects.~   "
26627|NCT02708654|"~     Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of~     Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering~     to improve outcomes among CHF patients at high risk of readmission.~   "
26628|NCT02708641|"~     This is a phase II study to evaluate the effect of pembrolizumab on the duration of~     remission in acute myeloid leukemia. Pembrolizumab is given after complete remission is~     obtained in those with AML at least 60 years old who are not candidates for allogeneic stem~     cell transplant. The primary purpose of this study is determine if the time to relapse can~     be extended. Additionally, the safety and tolerability of pembrolizumab will be closely~     monitored.~   "
26629|NCT02708628|"~     To investigate the efficacy of prophylactic use of a topical gel containing extract of~     allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in~     the second cesarean section.~   "
26630|NCT02708615|"~     This study compares two different types of speculum insertion to determine the level of~     discomfort they might cause. This study compares the straight horizontal insertion (SHI) of~     the speculum and the vertical insertion and rotation (VIR).~      Participants are randomly assigned to one of the two insertion groups and are not told which~     group they are in until the examination is over. Participants rate their level of discomfort~     immediately after insertion of the speculum.~      Basic demographic information (e.g., age, ethnicity, number of vaginal deliveries,~     menopausal status, etc.) and clinical information are also collected to determine if other~     factors influence the level of discomfort experienced.~      *NOTE* This is NOT a paid study.~   "
26631|NCT02708602|"~     Labor and delivery is a unique physiological experience of women. Inappropriate length of~     labor progress during vaginal delivery may produce great risks for mother and fetus.~     Especially the slow progress is one of the most important reasons for the occurrence of~     cesarean section during vaginal delivery, which still with a high incidence in recent~     years.Previous studies have found that there was a significant correlation between the~     genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal~     delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic~     receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship~     between the genetic polymorphisms and labor process after labor analgesia.~   "
26632|NCT02708589|"~     In this study, patients undergoing the bariatric surgery will be assigned to take either~     probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery.~     Their anthropometric and biochemical measurements will be assessed every 3-6 months, and~     will be compared in two groups.~   "
26633|NCT02708576|"~     The purpose of this study is to determine the safety and tolerability of NGM313, both single~     dose and multiple doses, in normal healthy overweight and obese adult participants.~   "
26634|NCT02708563|"~     Feasibility study to randomize non-vigorous newborn infants born through meconium-stained~     amniotic fluid to endotracheal suctioning or immediate resuscitation.~   "
26661|NCT02708212|"~     The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However,~     the optimal sequence of performing a same-day BDE has not been well-established.The primary~     aims of this study are to compare the sedative doses and patient discomfort between the~     study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD~     followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to~     assess colonoscopy performance, including the cecal intubation time and adenoma detection~     rate between the two endoscopic sequences.~   "
26662|NCT02708199|"~     Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal~     follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance~     Containment Tier I.~   "
26635|NCT02708550|"~     Epidemiological studies have shown that patient transfer is a risk factor for back pain,~     back injuries and long term sickness absence, whereas consistent use of assistive devices~     during patient transfer is associated with reduced risk of back injury. In consequence,~     Danish hospitals have made great efforts to increase knowledge, availability and use of~     assistive devices to reduce work-related physical strain due to patient transfer. Yet, a~     recent survey among more than 300 nurses and nurses' aides showed that two thirds rarely~     uses assistive devices during patient transfer. Thus it seems relevant to investigate~     barriers, opportunities and practical solutions for increasing use of assistive devices~     among healthcare workers. The purpose of this study is to evaluate a participatory~     organizational intervention for improved use of assistive devices during patient transfer.~   "
26636|NCT02708537|"~     The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because~     it could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy~     rates.~   "
26637|NCT02708524|"~     This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational~     contact lens with currently-marketed contact lenses. The objective of the study is to~     evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.~   "
26638|NCT02708511|"~     This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography~     (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer~     antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer~     cells such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu~     64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better~     treatment.~   "
26639|NCT02708498|"~     The research on ageing during the last couple of decades has increasingly focused on~     questions regarding the quality of life and life satisfaction of the old people. Yet the~     research indicates that when it comes to the final stage of life, the end includes~     unnecessary suffering and the quality of life drops. Palliative care has traditionally been~     provided successfully to younger persons dying from incurable illnesses while older people~     dying of multiple morbidities or old age has received far less of this type of care.~     However, sixty percent of all people who died in Sweden in 2010 were at least 80 years old~     and it is well known that dying among older people often is a prolonged period of suffering.~     One reason might be that it is more difficult to identify when the final stages of life~     begins for older persons.~      The purpose of this project is to implement and evaluate how a knowledge-based model for~     palliative care in nursing homes affects the quality of life and the participation in the~     care process for older persons in nursing homes and their next of kin. A second aim is to~     explore the staff's implementation process of palliative care and the role of the~     leadership. The final aim is to investigate which factors (barriers and facilitators) that~     affect the implementation process of this model.~   "
26640|NCT02708485|"~     The aim of this study is to evaluate the effect of a 3-month walking program on brain energy~     metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients~     with mild AD are followed and compared over a 3-month period of time: Control (non-active)~     and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks)~     groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain~     fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the~     study.~   "
26641|NCT02708472|"~     This clinical trial is an investigator-initiated open label study designed to evaluate the~     safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.~   "
26642|NCT02708459|"~     Comparing different drugs used in Transversus abdominus plane analgesia after donor~     hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group,~     and Dexmedetomedine group according to the used drug~   "
26643|NCT02708446|"~     The primary goal of this study is to directly compare repeat doses of sublingual and buccal~     routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order~     to determine if sublingual route confers an advantage with respect to efficacy and median~     time to complete abortion.~   "
26644|NCT02708433|"~     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at~     equal dosages, and a lower dosage of the drug might be used with an effect equal to higher~     dosage not buffered. Clinical data are needed to confirm these anecdotal data. No data exist~     comparing buffered local anesthetics at lower drug concentrations to current dosages~     commonly used in dental and oral surgical procedures~   "
26645|NCT02708420|"~     Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus~     presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or~     reduction of this increment is important for hemodynamic control. In this randomized single~     blind study, the aim of this study is to compare the hemodynamic responses of two different~     laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac~     bypass surgery patients.~   "
26646|NCT02708407|"~     This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically~     effective treatment for patients with severe heart failure and moderate chronic kidney~     disease, thus improving quality of life and symptoms.~   "
26647|NCT02708394|"~     This study will investigate the molecular mechanisms of atypical-antipsychotic induced~     insulin resistance. This will be accomplished by administering olanzapine or placebo to~     healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues~     known to play an important role in insulin resistance pathophysiology.~   "
26648|NCT02708381|"~     The main purpose of this study is to pilot a real time electronic consultation with an~     Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC).~     Investigators want to see for which type of patients this information is the most useful,~     and work out the practical ways of making this process work.~   "
26663|NCT02708186|"~     This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of~     Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy~     bodies (DLB).~   "
26664|NCT02708173|"~     This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People~     Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years~     old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus~     Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine~     after 7 days.~   "
26649|NCT02708368|"~     CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and~     includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular~     diseases in the context of renal insufficiency. Clinical pictures of peripheral artery~     occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours~     among other main risk factors (smoking, obesity, etc.) additional cardiovascular~     complications. For this reason it makes sense to monitor these patients regularly. For this~     purpose the determination of different biomarkers would be appropriate for control of the~     course of disease.~      During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und~     MGP were established as indicators for the disease activity, as diagnostic criteria for the~     existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death)~     within the scope of CKD-MBD. For the clinical routine care application of these parameters~     standard operating procedures (SOP) are missing for the determination method relating to~     optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the~     reproducibility of study results and to transfer these parameters in the clinical daily~     routine for risk stratification.~   "
26650|NCT02708355|"~     The purpose of this pilot study is to investigate the association between gastric acid~     suppression and relief of 24 hour heartburn following treatment with the proton pump~     inhibitor (PPI) drug esomeprazole in frequent heartburn patients.~   "
26651|NCT02708342|"~     RESEARCH METHODS Study Design Observational, Retrospective, Single-center, Single-arm Study~     of patients treated with raltegravir plus abacavir and lamivudine.~   "
26652|NCT02708329|"~     The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques~     in patients with bifurcation lesions in the CTO segment.~   "
26653|NCT02708316|"~     Research already found that patients with autistic spectrum disorders lack of Prevotella~     intestinal type, then schizophrenia patients may also show the specific intestinal type, so~     investigators want to detect the gut metagenome of schizophrenia patients by high-throughput~     DNA sequencing to find specific intestinal type, so as to achieve the purpose of~     schizophrenia diagnosis. According to the detection of inflammatory factors in the blood,~     nerve growth factor in the cerebrospinal fluid, to find the mechanism of the~     gut-microbes-brain axis.~   "
26654|NCT02708303|"~     The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have~     a consistent evaluation tool for patients undergoing foregut surgery in order to standardize~     and validate outcome measures.~   "
26655|NCT02708290|"~     Visual puzzles have been used for centuries to facilitate early development in kids. Mental~     Imagery Therapy for Autism (MITA) is a unique, early-intervention application for children~     with Autism Spectrum Disorder (ASD). The app includes bright, interactive puzzles designed~     to help children learn how to mentally integrate multiple features of an object, an ability~     that has proven to lead to vast improvements in general learning. Success with MITA puzzles~     could overtime result in significant improvements in a child's overall development,~     specifically in the realms of language, attention and visual skills.~      SCIENCE BEHIND THE PROJECT:~      MITA is based on Pivotal Response Treatment (PRT), one of the best-supported therapies for~     children diagnosed with ASD. MITA aims to develop one of four pivotal skills targeted by~     PRT: a child's ability to notice and to respond to multiple visual cues presented~     simultaneously. This ability is typically impaired in individuals with autism, leading to~     what is commonly described as stimulus overselectivity, or tunnel vision. Improving the~     capacity to discern and respond to multiple cues has been shown to reduce stimulus~     overselectivity, which in turn leads to vast improvements in general learning.~      The visual exercises follow a systematic approach for developing a child's ability to notice~     multiple characteristics, or features of an object. MITA starts with simple exercises that~     teach a child to attend to only one feature, such as size (see screenshot 1) or color~     (screenshot 2). Over time, the exercises get more difficult and require the child to attend~     to two features simultaneously, such as both color and size (screenshot 3). In order to~     solve these puzzles, a child must learn how to hold two pieces of information in their mind~     (both the size and the color of an object) and make a decision based on the combination of~     these features. Once a child has practiced attending to two features, the program moves on~     to puzzles that require attending to three features, such as color, size and shape~     (screenshot 4), and then eventually to puzzles that involve attending to an ever-increasing~     number of characteristics.~      As a child progresses through MITA's systematic exercises, he or she is developing the~     ability to simultaneously attend to a greater number of features, reducing the propensity~     towards tunnel vision, and thus developing an essential component of language. The ability~     to mentally build an image based on a combination of multiple features is absolutely~     necessary for understanding syntax, spatial prepositions and verb tenses.~      MITA is designed for early childhood and intended for long-term, daily use. It is designed~     to be engaging and educational, as well as adaptive and responsive to the individual~     abilities of each child.~   "
26656|NCT02708277|"~     The purpose of this study is to compare the outcome of loop intrauterine contraceptive~     device and heart-shaped intrauterine balloon for the adjunctive treatment of severe~     intrauterine adhesions in patients with infertility.~   "
26657|NCT02708264|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. Multiple gestations are at increased risk of SPTB. A~     short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good~     predictor of SPTB, in both singletons and twins.~      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy~     of the cervical pessary has been assessed in several populations including singletons with~     short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized~     clinical trials (RCTs) have been published, and several are ongoing. However, no consensus~     on use of the cervical pessary in pregnancy or guidelines for management have been assessed.~   "
26658|NCT02708251|"~     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive~     method that may be underutilized due to fear of pain during insertion. Although providers~     frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there~     is no evidence for any pain reduction. Women can experience high levels of pain when the IUD~     is placed inside the uterus, and fear of this pain could be a reason that women decide not~     to use this method.~   "
26659|NCT02708238|"~     A multicenter prospective, randomized comparative study will be conducted in infants with~     colic, according to Rome III criteria. Enrolled infants will be assigned at random to~     receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L~     reuteri DSM 17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days~     and they will be followed for 4 weeks. Treatment success will be assessed at the end of~     study period. Daily crying and fussing times will be recorded in a structured diary, and~     maternal questionnaires will be completed to monitor changes in infant colic symptoms and~     adverse events.~   "
26660|NCT02708225|"~     Medical clowns are known to assist in relaxing children and allowing better cooperation~     during performance of medical procedures.~      The ability of medical clowns to improve the motivation of children to perform active tasks~     was never examined to date.~      The investigators would like to examine the influence of the clowns' presence on the~     performance of pulmonary function test.~   "
26665|NCT02708160|"~     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults~     to evaluate remineralization of early caries lesions.~   "
26666|NCT02708147|"~     This study aims to evaluate the recovery of children with bronchiolitis with and without~     physical therapy treatments.~      The experimental group will receive educational information and 5 sessions of physiotherapy~     with the same protocol, at home or in physical therapy office. The control group will only~     be evaluated.~      For both the experimental and control groups the lung sounds are recorded and the Wang's~     respiratory severity scale calculated initially and on the 3th, 5th and 21st days and~     computorized. After 3 months of the initial contact, there will be an interview by the phone~     about relapses or other clinical signs of bronchiolitis until then.~      It is expected that the children receiving physiotherapy have a better recovery than the~     control group.~   "
26667|NCT02708134|"~     This is a prospective, observational, multi-center cohort study of pediatric cardiac~     arrests.~      The purpose of the study is to determine the association between chest compression mechanics~     (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the~     investigators will determine the association of post cardiac arrest care with patient~     outcomes.~   "
26668|NCT02708121|"~     This trial will test a primary care-based intervention that aims to increase the number of~     patients who enter evidence-based behavioral weight loss treatment.~   "
26669|NCT02708108|"~     This study tests the ability of a focused dietary, exercise, and activity intervention to~     reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to~     improve disease response and reduce toxicity.~   "
26670|NCT02708095|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as baricitinib in participants with systemic lupus erythematosus.~   "
26671|NCT02708082|"~     Study consists of five visits over a one to three month time period.~   "
26672|NCT02708069|"~     The goal of this project is to develop and test e-Unstuck, an e-learning intervention that~     (1) provides advanced training to parents of children with Autism Spectrum Disorder without~     Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On~     Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art,~     Dynamic e-Learning Platform, an established platform with high ratings of quality, value,~     usability, and feasibility from end users. As a result of the pilot efficacy test, the~     investigators hypothesize that (1) parents who interact with the e-Unstuck software will~     report greater knowledge and use of UOT principles, less parenting stress and greater~     parenting sense of competence, and improved child executive function (EF) and social skills~     compared to control parents, (2) parents who spend more time engaged with the intervention~     will show greater improvements in outcome variables, and (3) parents who interact with the~     e-Unstuck software will find the software to be of high quality, value, usability, and~     feasibility.~   "
26673|NCT02708056|"~     The objective of this study is to evaluate the efficacy and safety of sugammadex in~     reversing profound neuromuscular block induced by rocuronium in infant patients~   "
26674|NCT02708043|"~     The current study retrospectively assesses laryngeal mask airway use during pediatric~     adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction~     levels.~   "
26675|NCT02708030|"~     This randomised trial is undertaken to assess whether MAD or LGIT is non-inferior to KD with~     regard to seizure control at twenty-four weeks among children with drug resistant epilepsy.~     The hypothesis of the study is that in 1 to 15-year-old children with drug resistant~     epilepsy, use of Modified Atkins Diet (MAD) or Low Glycemic Index Therapy (LGIT) as an add~     on to the ongoing anti-epileptic drugs would not be inferior to ketogenic diet by >15% in~     terms of seizure reduction from baseline seizure frequency at 24 weeks.~      The primary outcome of the study is to determine the efficacy of MAD as compared to KD and~     LGIT as compared to KD for seizure reduction in drug resistant epilepsy following 24 weeks~     of dietary therapy in 1 to 15-year-old children on anti-epileptic drugs. The change in~     seizure frequency will be estimated as percentage change in seizure reduction at 24 weeks as~     compared to baseline.~   "
26676|NCT02708017|"~     The purpose of this study was to compare the analgesic efficacy of the ultrasound guided~     bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for~     postoperative analgesia after laparoscopic cholecystectomy~   "
26677|NCT02708004|"~     This clinical study will be conducted to evaluate the effect of AC-080 on fluid homeostasis~     in healthy subjects.~   "
26678|NCT02707991|"~     Effective all-oral medications are finally available to cure hepatitis C virus, which~     affects more than 4 million Americans and one-in-four people living with HIV. However, many~     barriers exist that prevent people with HIV/HCV co-infection from getting this curative~     treatment, including low knowledge, competing demands, and drug interactions with HIV~     medications.~      This study evaluates if a hepatitis C nurse case management intervention in an HIV primary~     care clinic will improve patient attendance to hepatitis C care and help people start~     hepatitis C treatment earlier. Half of the participants will receive brief case management~     with a nurse, while the other half will receive usual clinic care.~   "
26679|NCT02707978|"~     The purpose of this research study is to evaluate tau distribution in the brain of subjects~     with: FTD caused by different genetic mutations, any mutation carriers (with or without~     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.~   "
26680|NCT02707965|"~     Some epilepsy patients are described as GB when they have worsened seizures or side effects~     related to switching between brand name and generic, or between generic antiepileptic drug~     (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible~     reasons for patient problems with the drug switching. Factors that will be studied in GB~     epilepsy patients include physiologic, psychological, and genetic factors, including in this~     protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.~   "
26681|NCT02707952|"~     The purpose of this study is to evaluate the efficacy and safety of ABT-493/ABT-530 in~     Japanese adults with chronic hepatitis C virus infection.~   "
26682|NCT02707939|"~     Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the~     world. Approximately 1% of the population worldwide is affected by this disorder. Children~     with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on~     very rigid and predictable schedules and routines. Any changes in their schedules can often~     trigger negative emotional outbursts. The need to come to the hospital for procedures can be~     one such trigger. The purpose of this study is to examine the post anesthesia behavior~     outcomes of children with ASD.~   "
26683|NCT02707926|"~     Hypothesis:~      Antiretroviral drugs (ARVs) with enhanced LT penetration characteristics in vitro and in~     macaques will translate into an ARV regimen with increased LN and GALT concentrations and a~     faster decay and more potent suppression of HIV replication in LT in HIV-infected persons.~      Objectives:~        1. Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics~          (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.~        2. Determine virological responses of antiretroviral therapy in plasma, peripheral blood~          mononuclear cells (PBMCs) and lymphoid tissue (LT).~   "
26684|NCT02707913|"~     The purpose of the study is to compare the bioavailability of a generic product of~     amlodipine with that of a reference product when administered to healthy volunteers under~     fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by~     Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited,~     and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of~     amlodipine obtained from two formulations will be used to access the interchangeability of~     the products~   "
26685|NCT02707900|"~     The purpose of this research study is to 1) evaluate the safety of a series of injections~     with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help~     scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the~     immune system can be made stronger to eliminate the activated HIV virus.~   "
26686|NCT02707887|"~     The purpose of this study is to:~        1. determine if a smartphone enhanced treatment for LETS ACT (LETS ACT-SE) is associated~          with increased long term treatment engagement, and in turn, improved long term~          treatment outcomes, and~        2. use functional magnetic resonance imaging (fMRI) to identify the effects of LETS ACT-SE~          on the neuromarkers of reward sensitivity.~   "
26687|NCT02707874|"~     This is a clinical study to investigate and compare a new programmed intermittent bolus~     (PIB) delivery method for continuous popliteal sciatic nerve block for pain relief in~     patients undergoing major ankle surgery compared with the current practice of continuous~     local anesthetic infusion (CI).~   "
26688|NCT02707861|"~     Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system~     cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in~     combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited~     treatment options. This study will collect further information on the safety and~     tolerability of intravenously administered (IV) ibalizumab combined with an optimized~     background regimen for treating multi-drug resistant HIV-1 infection, and will provide~     continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.~   "
26689|NCT02707848|"~     This 3-year school-based epidemiological study on child and adolescent mental disorders aims~     to obtain the prevalence rate and identify the psychosocial, individual, environmental, and~     familial risk factors for mental disorders including learning disability, autism spectrum~     disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct~     disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders,~     phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use~     disorders in Taiwan.~   "
26690|NCT02707835|"~     The ultrasound imaging could be used to examine the thickness of dermis and the space~     between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging~     correlate to other measurement of edema is unknown.~      The purpose of this study is to investigate~        1. The reliability of measurement of edema using ultrasound imaging, and the correlation~          of measurement of ultrasound with other measurement tools.~        2. The different effect of edema control by manual lymph drainage technique and epidermis~          taping technique, and the cost-effective assessment.~      Our hypothesis :~        1. The measurement of edema with ultrasound imaging is a reliable method and correlate~          with other edema measurement with moderate correlation.~        2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and~          epidermis taping, and different cost-effectiveness analysis.~   "
26691|NCT02707822|"~     The purpose of the study is to identify factors that may influence tacrolimus (TAC)~     pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on~     pharmacokinetics of TAC in Taiwanese.~   "
26692|NCT02707809|"~     The microcirculation is altered in acute kidney injury and chronic kidney disease. The~     microcirculation is poor in end-stage renal disease patients receiving hemodialysis. Kidney~     transplant can improve the life quality of these patients. However, surgical stress and~     inflammatory response may cause microcirculatory dysfunction and intestinal injury.~     Moreover, the transplanted kidney would suffer from the ischemia and reperfusion injury, and~     it may result in acute kidney injury. In ischemia and reperfusion injury animal model,~     dexmedetomidine has been proven to attenuate kidney and intestinal injury. In our previous~     study of surgical stress and pain stimulation rat model, we found that dexmedetomidine~     attenuate the intestinal microcirculatory dysfunction. In patients receiving coronary artery~     bypass graft surgery, dexmedetomidine increases urine output and decreases postoperative~     serum level of neutrophil gelatinase-associated lipocalin.~      This study aims to investigate whether perioperative dexmedetomidine infusion may attenuate~     microcirculatory dysfunction, kidney injury, and intestinal injury for patients undergoing~     kidney transplant.~   "
26693|NCT02707796|"~     Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new~     technological development in medical science. Our aim in this study is to identify the~     correlation between arterial oxygen pressure (PaO2) and ORI, and to identify the specificity~     and sensitivity of ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery~     patients.~   "
26694|NCT02707783|"~     The aim of the study is feasibility of complete coronary revascularization with~     bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a~     group of consecutive patients with stable and unstable angina in Russian population.~      The hypothesis of this registry study: 1) Complete coronary revascularization with BVS~     implantation will be feasible to perform in at least 70 percent of patient population with~     stable and unstable angina qualified for revascularization after coronary angiography, 2)~     Complete revascularization with BVS is as safe and effective as revascularization with~     standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published~     literature comparators in matched populations).~      Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres.~     12 month clinical observation and 5-year clinical follow-up is expected.~   "
26695|NCT02707770|"~     Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung~     disease that is a core part of the management of patients with Chronic Obstructive Pulmonary~     Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise~     and this is often discovered when they are being evaluated for PR. Current practice is to~     administer oxygen to COPD patients with exercise-induced desaturation, but this is based on~     very limited evidence. This limited evidence relates to a short-term increase in exercise~     capacity and it is not known if this translates into longer term increases in activity or~     whether providing these patients with oxygen improves outcomes after PR.~      In addition it is not known if patients given ambulatory oxygen continue to use it after~     completing PR. Evidence for a beneficial effect of oxygen would provide a more solid~     evidence base for its use. Conversely demonstration of no effect would allow reassessment of~     the use of oxygen and whether the costs are justified. Therefore the aims of this study are~     to assess the effects of oxygen on outcomes from PR and assess the usage of ambulatory~     oxygen following completion of PR.~   "
26696|NCT02707757|"~     Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are~     two current possible treatments for anaemia which are iron and erythropoietin stimulating~     agents (ESA). Dosages of these medications are currently guided by a patient's ferritin~     levels and haemoglobin, but these markers are known to be inaccurate. The current clinical~     protocol therefore tends towards overuse of both agents which can be associated with~     toxicity, and the reliance on these markers prevents retrospective assessment of treatment~     responsiveness. This study is designed to investigate the factors which predict which agent~     would produce a better response. Patients with a fall in haemoglobin will be given treatment~     with either iron or an increased dose of ESA as they are currently, but allocated at random~     rather than by poorly performing biochemical markers. The iron treated and ESA treated~     groups can then be analysed for factors which predict response in o~   "
26697|NCT02707744|"~     It is an observational study in patients with heart failure investigating the incidence of~     arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In~     addition to gathering routine clinical information, research assessments include a symptoms~     questionnaire and a corridor walk test. Patients will be followed for clinical events~     (interventions for arrhythmias, hospitalisation, death) for up to 5 years.~   "
26698|NCT02707731|"~     This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing~     stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol~     samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart~     rate, respiratory rate and oxygen saturation before and after hydrotherapy.~   "
26699|NCT02707718|"~     Monocentric prospective study on consecutive patients attending the emergency department and~     suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of~     interest in sepsis.~   "
26700|NCT02707705|"~     Preoperative anxiety before cesarean section is common and may be severe. Stress~     consequences are often deleterious for the mother and for the upcoming newborn. Means to~     reduce anxiety before cesarean section are limited. Anxiolytic drugs are avoided in the~     context of the birth of a newborn. Auricular acupuncture has been shown to relieve anxiety~     disorders. The aim of this study is to evaluate the anxiolytic effect of auricular~     acupuncture administered before an elective cesarean section. Anxiety will be measured at~     T0: inclusion (approximately 1-2 hours before cesarean section) and T1: departure to~     surgical unit (approximately 30 minutes to 1 hour after T0). Patches (needle or needle-free)~     will be set up at T0 just after the initial anxiety assessment (anxiety Visual Analog Scale~     aVAS).~   "
26701|NCT02707692|"~     The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines~     on the HIV transcriptional activity in individuals who are virologically suppressed for at~     least 48 weeks on similar ART. The proposed study is a randomized double-blinded control~     trial conducted over 28 weeks. Randomized interventions will be injections of Influenza~     vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but~     in a randomized order.~   "
26702|NCT02707679|"~     Patellofemoral Pain Syndrome (PFPS), also known as the anterior knee pain, is one of the~     most common musculoskeletal disorders. Most of the patients suffer from knee pain for long~     time. The aim of this study was to investigate the short-term effects of Mobilization with~     movement and Kinesiotaping on pain, function and balance in patient with PFPS.~   "
26703|NCT02707666|"~     This is a single institution, single-arm, window of opportunity pilot trial of pembrolizumab~     in patients with resectable malignant pleural mesothelioma. All patients will undergo a~     pretreatment PET/CT scan for clinical staging and a VATS procedure to acquire pretreatment~     tissue. Three cycles of pembrolizumab will then be administered (200 mg IV every 21 days). A~     PET/CT scan will then be repeated to assess response to pembrolizumab and then surgical~     resection will be performed via an extended/pleurectomy decortication at least 4 weeks after~     the third dose of pembrolizumab. Standard adjuvant chemotherapy consisting of cisplatin and~     pemetrexed for 4 cycles (every 21 days) will be given starting about 6-8 weeks following~     surgery, after a new baseline CT scan is obtained. Restaging CT scans will be obtained to~     assess response after every two cycles of chemotherapy. After the completion of standard~     chemotherapy, optional adjuvant treatment with pembrolizumab will be given to eligible~     patients for 1 year post-surgery.~   "
26704|NCT02707653|"~     This study will investigate the use of misoprostol for first-line treatment of incomplete~     abortion at tertiary hospitals in Myanmar.~   "
26705|NCT02707640|"~     This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability~     study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic~     pulmonary fibrosis (IPF) receiving background pirfenidone therapy.~   "
26728|NCT02707341|"~     The primary objective of the Corrona Psoriasis Registry is to study the comparative safety~     of approved psoriasis therapies in a national cohort of psoriasis subjects treated by~     dermatologists. This includes assessing the incidence and nature of adverse events of~     special interest, including malignancy, in a real world population of psoriasis patients on~     new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the~     epidemiology and natural history of the disease, comorbidities, current treatment practices,~     and comparative effectiveness.~   "
26729|NCT02707328|"~     This study is looking at determining the maximum safe dose of CyberKnife when given with~     chemotherapy for unresectable adenocarcinoma of the pancreas.~   "
26706|NCT02707627|"~     A new era of outcomes for pediatric burn patients has begun as burn care continues to~     improve. Unfortunately, complete restoration of burn-injured skin may be limited by the~     development of hypertrophic scarring. Treatment with ablative fractional carbon dioxide~     laser therapy is one of the newest forms of scar therapy available. Although laser therapy~     has only been adopted by burn clinicians within the last several years, early evidence~     suggests that it may offer significant benefits. At present, a well-designed randomized~     controlled trial that evaluates the effectiveness of laser therapy for improving~     hypertrophic burn scars in children has not yet been conducted. Thus, the proposed study~     will answer the following research question: In children aged 1 to 18 years with a~     hypertrophic burn scar, is the addition of ablative fractional carbon dioxide laser therapy~     to standard scar management more effective at improving the appearance and texture of the~     scar compared to standard scar management alone, as measured by the Vancouver Scar Scale~     from baseline to month 12? Ultimately, the completion of this study may lead to a~     fundamental change in the standard treatment of pediatric hypertrophic burn scars. In~     addition, the study findings will also be applicable to children and adults with scars~     resulting from other etiologies.~   "
26707|NCT02707614|"~     This study aims to describe the postoperative functions of patients after undergoing open or~     robotic prostastectomy. Primary endpoints will focus on complications in the~     post-anaesthesia care unit (PACU) which prevent dischard from PACU to the general ward. This~     include Aldrete scores and other complications that can be registrered descriptively.~     Furthermore, the study seeks to compare what influence open versus robotic prostastectomy~     have on peri- og postoperative complications.~   "
26708|NCT02707601|"~     This study will evaluate efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) as measured by the~     proportion of participants achieving hepatitis C virus (HCV) RNA below the lower limit of~     quantification (LLOQ) 12 weeks after the last dose of LDV/SOF (sustained virologic response~     (SVR) 12).~      This study will consist of 2 parts. In Part 1, the participants will be randomized to switch~     from stable antiretroviral (ARV) therapy to either E/C/F/TAF or F/R/TAF. The participants~     maintaining HIV-1 RNA < 50 copies/mL and tolerating E/C/F/TAF or F/R/TAF through Part 1 will~     continue to Part 2 where they will receive the LDV/SOF treatment.~   "
26709|NCT02707588|"~     The general aim of the study is to evaluate the anti-tumour activity and the tolerance~     profile of Pembrolizumab + RT in comparison to cetuximab + RT in patients with locally~     advanced HNSCC and to explore potential correlations between treatment outcome and the~     immune landscape.~   "
26710|NCT02707575|"~     The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes~     with exudative age-related macular degeneration (AMD) before therapy with intravitreal~     Ranibizumab, and identify associations with visual and anatomical outcome after treatment.~   "
26711|NCT02707562|"~     32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting~     of three consecutive treatment periods: two 1-week periods followed by one 2-week period,~     evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days~     follow-up period.~      During the course of the study, subjects will be examined for any side effects that may~     occur (safety and tolerability).~      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes~     in pulmonary function (efficacy) will be explored throughout the study. The amount of~     GLPG1837 present in the blood (pharmacokinetics) will also be determined.~   "
26712|NCT02707549|"~     Fluid management of children during neurosurgery is not well established. Hypotonic~     solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse~     operative conditions. This study compares two different isotonic solutions administered~     perioperatively regarding acid base and fluid electrolyte disturbances.~   "
26713|NCT02707536|"~     The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in~     extraction socket healing with or without particulate bone graft. The hypothesis of this~     study is that PRF will enhance the extraction socket healing and new bone formation when~     compared to extraction sockets grafted without PRF.~   "
26714|NCT02707523|"~     The proposed study will be a randomized, double masked, placebo-controlled pilot trial of~     azithromycin treatment in children with RSV-induced respiratory failure.~   "
26715|NCT02707510|"~     The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency~     And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and~     experiences from an inter-professional perspective to mitigate distress among patients with~     an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention~     emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach~     involving psycho-education and process-oriented experiences. The curriculum includes themes~     illustrated via PowerPoint slides with semi-structured delivery, video presentations, a~     variety of mindfulness meditation practices, and selected readings that serve to reflect and~     capture the theme for the week of the curriculum.~   "
26716|NCT02707497|"~     The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO)~     can rapidly increase the platelet counts, shorten the time of the platelet returned to~     normal, reduce platelet transfusion and bleeding events, decrease the length of ICU stay,~     and eventually reduce the 28-day mortality in septic shock patients with thrombocytopenia.~   "
26717|NCT02707484|"~     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or~     chronic gastrointestinal bleeding, currently lacks of effective treatment. The~     investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was~     safe and effective. This prospective multi-center randomized controlled clinical trial~     intends to investigate the efficacy of thalidomide to the recurrent small intestinal~     hemorrhage due to GIVM.~   "
26727|NCT02707354|"~     Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and~     mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The~     diagnosis is based on histological findings that involve colonic biopsies with a risk of~     bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made~     at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms.~     Endo-microscopy is a novel endoscopic technique that allow optical biopsies during a~     conventional endoscopy and has proved its efficiency in several indications. In a pilot~     study the investigators showed that it had good sensibility and sensitivity compared to~     histology as gold standard. Therefore this study aim to identify endo-microscopic criteria~     allowing the early diagnosis of GHVD before its clinical manifestations.~   "
26718|NCT02707471|"~     Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent~     recurrence and reduce breast cancer-related mortality for breast cancer patients with~     hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%)~     and in our preliminary work, 65% of breast cancer patients taking AET reported one or more~     non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the~     past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly~     related to non-adherence and early discontinuation of treatment. Poor adherence to AET due~     to symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial,~     we will conduct user testing of the self-management intervention protocol with 20 women. In~     the proposed randomized clinical trial, 400 women who are taking AET for breast cancer will~     be randomly assigned to one of two conditions: 1) a self-management intervention for~     improving adherence and symptom management, or 2) a general health education control~     condition. The self-management intervention integrates three key theory-based strategies for~     improving adherence to AET: coping skills training for managing symptoms (e.g., arthralgia,~     vasomotor symptoms), behavioral strategies for improving medication adherence, and symptom~     and medication education. The intervention addresses the specific symptoms a woman is~     experiencing and is designed to meet the needs of women who are at high risk for~     non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management~     intervention is administered by a nurse via the telephone, and combines the use of phone~     calls and tailored interactive voice messaging based on information exchanged during phone~     sessions and real-time adherence data obtained from smart medication bottles. Women randomly~     assigned to the control condition will receive a general health education intervention that~     is delivered by a nurse via the telephone. This study will take place in the Duke Cancer~     Institute breast clinic and in community hospitals that are members of the Duke Cancer~     Network, which will allow access to women receiving care outside the medical center setting~     and increase generalizability of findings to a variety of settings. Adherence to AET will be~     assessed over the 18 month period following study enrollment using wireless smart medication~     bottles that provide real-time adherence data. Patient-reported outcome measures assessing~     symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained~     at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation~     of the self-management intervention, the cost effectiveness of the intervention will be~     evaluated.~   "
26719|NCT02707458|"~     DEPEND is an open-label but dosage-masked trial of the retired cholesterol-lowering drug~     probucol as an agent to increase availability of apolipoprotein E (apoE) in the~     cerebrospinal fluid (CSF) of cognitively intact older persons at risk of Alzheimer's~     dementia. Absorption of oral probucol is variable. In a sample of 23 cognitively intact~     persons over age 55, DEPEND will therefore develop an algorithm to prescribe individualized~     dosing to achieve plasma concentration that will likely increase availability of CSF apoE.~     These persons will then use their individualized dosage for 12 months to assess longer-term~     effects of the drug on CSF apoE concentration, while monitoring closely for evidence of~     adverse consequences of use.~   "
26720|NCT02707445|"~     This study evaluated epidemiology and clinical outcome of clopidogrel related various~     genotyping in Korean patients who had undergone percutaneous coronary intervention as a all~     comer registry form.~   "
26721|NCT02707432|"~     The study will determine the feasibility and efficacy of adapting an evidence-based~     intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African~     American communities and determine the acceptability of mobile technology in these~     communities to support behavior change.~   "
26722|NCT02707419|"~     Postoperative rehabilitation is required for a successful outcome following total knee~     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to~     strengthen quadriceps, to restore normal gait, and to recover independence in activities of~     daily living. In the last decade action observation treatment, in addition to conventional~     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is~     growing evidence of the applicability of action observation training in rehabilitative~     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of~     cerebral palsy and of aphasia.~      Nevertheless those are small studies and one of them included a mixed population of hip and~     knee arthroplasty.~   "
26723|NCT02707406|"~     The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.~      The purpose of the study is to evaluate the safety, incidence and rate of wound closure~     following application of the product compared to standard of care in the treatment of~     difficult to heal diabetic foot ulcers.~   "
26724|NCT02707393|"~     In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation~     (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors~     (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen~     (RIC), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant~     related mortality and toxic late effects. Strict post-transplant monitoring and~     reintroduction of TKI as well as donor lymphocyte infusions (DLI) in case of relevant~     residual disease are part of the protocol.~   "
26725|NCT02707380|"~     This study is designed to investigate the effect of a structured resistance training program~     on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type~     2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator~     will compare the experimental group receiving resistance training to a control group made of~     patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise~     modalities during their sessions, which is the current standard of care.~   "
26726|NCT02707367|"~     Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a~     highly interactive web-based tool that provides guidance for providers and people in~     recovery, and promotes widespread implementation of Person-Centered Recovery Planning~     (PCRP). The Recovery Roadmap prototype was developed and tested by the Center for Social~     Innovation (C4), in partnership with Yale University's Program for Recovery and Community~     Health (PRCH), under a Phase I Small Business Innovative Research (SBIR) grant funded by the~     National Institute of Mental Health (NIMH) (1R43MH100712). Phase II will refine the~     prototype Roadmap to streamline content, provide additional handouts and exercises for~     providers and clients to complete together, expand the audio/video vignettes and case~     studies, and add interactive online coaching and support for providers. Phase II also~     involves a robust evaluation of the Roadmap, using a quasi-experimental design in a fully~     powered trial. Approximately 26 community-based mental health programs will be randomized~     into Recovery Roadmap (RR) or Illness Management and Recovery (IMR) conditions [in New York~     study sites, this practice is referred to as Wellness Self-Management (WSM)]. Participants~     will include both providers and clients, and data will include one pre-test and three~     post-tests with providers and clients, interviews with providers and administrators, network~     analytics, and administrative client data. This phase will culminate with the dissemination~     of findings and preparation for Phase III commercialization.~   "
26730|NCT02707315|"~     This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the~     treatment of potentially resectable adenocarcinoma of the pancreas~   "
26731|NCT02707302|"~     The purpose of this study is to support the rational use of iodophor-impregnated surgical~     adhesive drapes for preventing wound infections after total hip arthroplasty.~   "
26734|NCT02707263|"~     The primary purpose of this study is to demonstrate that a continuous infusion of~     intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore~     prophylactic levels of heparin in high-risk critically ill medical patients as compared with~     guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to~     measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood,~     will be used to demonstrate that Intravenous administration is more effective.~   "
26735|NCT02707250|"~     Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by~     considerable pain after surgery. More recently transversus abdominis plane (TAP) block was~     extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy.~     The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable~     supraumbilical analgesia.~   "
26736|NCT02707237|"~     Providing verbal counseling supplemented with both written and pictorial information then~     verbal counseling alone is a more effective method of counseling parents with threatened~     preterm delivery~   "
26737|NCT02707224|"~     A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of~     DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in~     comparison to each component administered alone in healthy male volunteers~   "
26738|NCT02707211|"~     To test whether active pneumococci immunization can alleviate inflammation and improve~     cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic~     disorders.~   "
26739|NCT02707198|"~     This study is being conducted to investigate the potential benefits of probiotic intake for~     preventing antibiotic associated diarrhea and Clostridium difficile infection in patients~     undergoing a systemic antibiotic treatment. The primary research question is: can daily~     intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea~     and Clostridium difficile infection in patients during antibiotic treatment?~   "
26740|NCT02707185|"~     METHODS:~      Subjects:~      All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents~     and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and~     training in CPR techniques according to their department training policy.~      Study Assessment Tool:~      An objective assessment tool has been developed and tested in medical code scenarios during~     training sessions recently done in the simulation lab. The tool has five domains: Airway,~     Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists~     of 3-8 tasks and skills (attachment A).~      Design:~        -  Phase I: In groups of five to six subjects, residents and nurses will undergo baseline~          assessment in CPR techniques in the simulation lab. Subject will be presented with a~          clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by~          observers based on the previously described assessment tool and will be video recorded.~        -  Phase II: All study subjects who completed phase I assessment will undergo standardized~          debriefing and demonstration of proper CPR techniques after reviewing their individual~          baseline videotape followed by repeated demonstration in CPR techniques during a~          clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge~          retention will be assessed periodically.~        -  Phase III: Rates of survival to hospital discharge and survival at 24 hours in~          hospitalized patients after cardiopulmonary arrest collected by the CPR committee and~          QA department longitudinally for one year after completion of project training (phase~          II) will be reviewed and compared to the same period one year earlier (CPR outcome data~          are being collected since 2005 at St. Luke's-Roosevelt Hospitals).~   "
26741|NCT02707172|"~     The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand,~     we compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by hand washing~     with soap and water vs. water only. In two three-day N-of-1 trials, residual DEHP was~     measured in a single female adult who washed exposed hands with soap-and-water or~     water-only. Subsequently, a crossover study was performed by randomly assigning another 28~     subjects equally to wash with soap-and-water or with water-only, and then each one received~     the other treatment 24 hrs later.~   "
26742|NCT02707159|"~     The majority patients diagnosed with pancreatic cancer have metastatic disease at the time~     of diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%.~     Treatment with chemotherapy can improve efficacy, but still the median progression-free~     survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median~     overall survival is less than one year. There is a urgent need for tools for predicting the~     efficacy of the treatment. The current trial aims at investigating the biomarker potential~     of circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by~     gemcitabine and nab-paclitaxel.~   "
26743|NCT02707146|"~     This project focuses on improving the patient-provider primary care visit interaction by~     addressing the need to align patient and provider priorities in a way that incorporates~     patients' goals and preferences while supporting the clinical work of their providers.~   "
26744|NCT02707133|"~     Choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire~     population and are increasingly incidentally identified during routine eye check- ups in~     community optometry services. Given the tendency to err on the side of caution, there is~     evidence of excessive referrals challenging service delivery in both tertiary eye units and~     specialist ocular oncology services. Although previous studies have examined the natural~     history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery~     of management remains uncertain. Management approaches display diversity with respect to the~     number and type of baseline investigations, the duration and frequency of monitoring of~     relevant patients. Utilisation of the skills of allied health professionals in appropriate~     cases would allow streamlining service delivery in a socialised healthcare system, maximise~     capacity, and allow community services to play an enhanced role. However, the evidence for~     this model of delivery is lacking. Within existing models of care for these lesions,~     patients are faced with delays, need for more than one attendances to the hospital and~     increased anxiety around prognosis.~      This project aims to answer the question of whether these low-risk, bland incidental~     findings might possibly be managed by allied health professionals with the use of clinical~     imaging and specific algorithms to make appropriate management decisions. We aim to validate~     a model of service delivery on a virtual basis that will accommodate for capacity pressures~     to accept all relevant referrals, while offering a safe service and optimising patient~     experience of care. We will thus validate the setting up of a virtual choroidal~     nevomelanocytic clinic in terms of safety and patient acceptability. More specifically, the~     degree of agreement between management decisions made by non-medical graders on the basis of~     imaging data alone as opposed to gold standard decisions (clinical and imaging tests~     combined) is examined. Health economics analysis of the proposed service delivery model will~     be undertaken to demonstrate cost-effectiveness.~   "
40721|NCT02523989|"~     The purpose of this study is to explore the relationship between arsenic methylation and~     blood metals in children with developmental delays and its correlation with health related~     quality of life.~   "
26748|NCT02707081|"~     Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV)~     lidocaine infusion for postoperative pain control after cesarean section.~      Study design: prospective randomized, double-blind, placebo-controlled study. Patients and~     methods: Initially, 165 pregnant full-term females, indicated to be underwent elective~     cesarean delivery for various indications were randomized equally to either group C~     (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group~     IV (intravenous lidocaine infusion).Five patients were excluded from each group for various~     reasons. The outcome measures were postoperative pain scoring, total pethidine consumption~     and the need for postoperative analgesia.~   "
26749|NCT02707068|"~     This study seeks to test the feasibility of a self-management manual with minimal telephone~     support by a healthcare professional. The study will also explore the acceptability of the~     intervention manual to patients.~   "
26750|NCT02707055|"~     Background:~      Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates~     appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more~     about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.~      Objective:~      To test if the drug PF-05190457 decreases alcohol craving.~      Eligibility:~      People ages 18 65 who have:~      Alcohol use disorder~      No other serious medical problems~      Woman must be postmenopausal or have had surgery to prevent pregnancy.~      Design:~      Participants will stay on the inpatient unit here at the Clinical Center for two 2-week~     stages, which will be separated by at least 2 days. The inpatient phase include:~      Taking the study drug or placebo by mouth twice daily~      Blood tests~      Tasting several sweet solutions~      Physical exams~      Smokers will smoke cigarettes through a device that gives information about how they smoke a~      cigarette.~      Exposure to alcohol, water, and food cues in a bar-like room. Participants answer questions~     on a computer.~      Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest.~     Saliva is collected~      through cotton rolls in the mouth.~      MRIs: Participants lie on a table that slides in and out of the cylinder, and a coil is~     placed over the head.~      They complete tasks on a computer screen while in the cylinder. This lasts up to 2 hours.~      Wearing a virtual reality headset, walking around a virtual room, and selecting virtual food~     and drink.~      Participants will have 8 hour long follow-up visits in our Outpatient Clinic These include:~      Counseling to abstain from alcohol use. Sessions may be videotaped.~      Physical exams~   "
26751|NCT02707042|"~     More than 250 million courses of antibiotics are prescribed annually in the ambulatory care~     setting in the United States alone, including more than 40 million in children under 18~     years of age. The perception that antibiotic use has minimal attendant adverse side effects~     contributes to the over-utilization of antibiotics in clinical circumstances when they are~     not strictly indicated. We have learned much about the human microbiome. The emerging view~     is of profound life-long bi-directional interactions between our microbiota and our cells.~     Perturbations in the microbiota affect metabolic, immune, and cognitive physiology in~     experimental animal models. When a person takes an antibiotic, the antibiotic diffuses via~     the blood into all body compartments, selecting for resistance. We propose to examine the~     effects of two commonly used antibiotics (the beta-lactam, amoxicillin and the macrolide~     azithromycin) on human microbial populations and on metabolic and immune physiology,~     studying healthy human volunteers in a randomized controlled clinical trial at the NIH~     Clinical Center. Our hypothesis is that in addition to acutely perturbing the human~     microbiome, these agents will have measurable metabolic and immunologic effects, with~     residual effects in the weeks that follow. To test this hypothesis, we will assess the~     effects of a brief therapeutic course of antibiotics on microbiome and metagenome~     composition. After an initial evaluation period, antibiotics will be given for 7 days or 5~     days (depending on the antibiotic), and there will be a post-treatment evaluation. A control~     group will receive no drug intervention. Specimens will be obtained from multiple sites at~     each of 10 time points occurring before, during, and after antibiotic administration, and~     used for estimating bacterial and fungal composition and gene content. We will also assess~     the effects of the antibiotic course on markers of innate and adaptive immunity as well as~     markers of metabolic and hormonal physiology. A subgroup of randomly selected subjects will~     be studied in the clinical center metabolic chamber to assess 24-hour energy expenditure and~     its components (sleeping, diet-induced, and activity energy expenditure), as well as~     macronutrient oxidation rates (carbohydrate, fat, and protein), during 3 of the 10 study~     visits. In addition to the primary data analyses, we will build a model that integrates the~     temporal data to begin to understand the complex intertwined physiology between microbiome~     and host.~   "
26752|NCT02707029|"~     Background:~      Researchers want to better understand pain by studying people with and without different~     kinds of pain. To do this, researchers will expose people to pleasant and unpleasant~     sensations. They will ask them questions about their pain. Researchers also want to see if~     these people are eligible for other research studies at the National Center for~     Complementary and Integrative Health.~      Objectives:~      To study the experience of pain. Also to find people eligible to join other NIH studies.~      Eligibility:~      People 12 years and older with and without pain disorders.~      Design:~      Participants will be screened by phone.~      Participants will have one required visit. This may include:~        -  Medical history~        -  Physical exam~        -  Questionnaires about themselves and their pain experience~        -  Blood and urine tests~        -  MRI: They will lie on a table that slides into a cylinder. They will feel different~          sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours.~        -  Quantitative sensory testing: They will be exposed to different pictures, sounds,~          tastes, and smells. They will also be exposed to pleasant and unpleasant sensations.~          These could include:~             -  Burning, itching, or cold sensations~             -  Pinpricks~             -  Pressure and pinches~        -  Electrocardiogram: Stickers on the chest record heart activity.~        -  Straps placed around the chest to measure breathing.~        -  Small sensors on the fingers or palms to measure pulse and sweating.~      Over the next 3 months, participants may have up to 4 other study visits. These last 2 to 4~     hours each. They include repeats of some of the tests in the required visit.~      Participants may be recorded at the visits.~   "
26753|NCT02707016|"~     The investigators aim to reduce the incidence of emergence delirium in children aged 2-7~     years old by using two different doses of sevoflurane during inhalatory induction of~     anesthesia.~   "
26754|NCT02707003|"~     Multi-center observational trial with study device blinded in order to assess in parallel~     standard monitoring and intervention practices related to management of respiratory~     compromise in the post-anaesthesia care unit (PACU)~   "
26755|NCT02706990|"~     The aim of this study is to evaluate the in vivo kinematics of TKA performed with two~     different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica~     PS) design by means of fluoroscopic analysis during activities of daily living (rising from~     a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of~     femoral rollback will be analyzed to assess if they are motor-task dependent and correlated~     with clinical outcomes.~   "
26756|NCT02706977|"~     The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel~     handheld system, RETeval, and evaluate contrast sensitivity testing in detecting~     pre-clinical retinopathy on a tablet device.~      Investigators also seek to assess if a medication called Sinemet™ CR can improve the~     electrical functions of the eye in participants with diabetes mellitus. This study will~     include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched~     non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG)~     delays will be randomized to a low or high dose Sinemet CR group.~   "
26757|NCT02706964|"~     Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb~     to their cancer within 2 years, and 80% will succumb by 5 years. The current National~     Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not~     recommend surveillance imaging for earlier detection of distant metastases, even for~     high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small~     isolated (few in number) breast cancer metastases is to perform surgical resection or~     locally ablative radiation therapy, however, the follow-up of breast cancer patients~     (including those with a >= 30% risk of developing metastases) is to wait for clinical~     symptoms to appear before using a dual positron emission tomography (PET) and diagnostic~     quality computed tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed~     tomography (CT) or a bone scan to identify the site and extent of spread. Unfortunately,~     once metastases become symptomatic they are often too large and/or numerous to treat with~     curative intent. The current national care guidelines that advocate against intensive~     surveillance for distant metastases are based on two studies performed in Italy from~     1985-1993 that concluded that the available imaging and treatment tools of the day did not~     prolong 5-year survival. Since then, however, there have been major improvements in imaging~     and treatment technology. To be treatable the metastases must be limited in number and~     limited in size, typically 6 or fewer metastases, each of size 5 centimeter or less. This~     state of metastatic presentation is called oligometastases. Numerous pilot studies have~     achieved dramatically improved overall and disease-free survival when oligometastases are~     treated using a combined systemic plus locally-ablative therapy of each oligometastasis. A~     scientific concern with the aforementioned research studies involving ablation of isolated~     oligometastases, was that they were not carried out with consistent use of surveillance~     imaging. Instead, these studies effectively preselected patients for enrollment based upon~     having an existing oligometastatic presentation. The primary objectives of the research~     study are to: (1) determine the feasibility of the stated interventions in a~     multi-institutional setting; (2) document the patterns of early metastatic spread of breast~     cancer; (3) document the proportion of high-risk breast cancer patients that have an~     oligometastatic presentation within this proactive imaging protocol, and (4) provide a basis~     to determine how to optimize future surveillance imaging protocols with respect to the time~     to progression, rate of tumor growth and organs that are affected.~   "
26758|NCT02706951|"~     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)~     monotherapy in subjects with moderately to severely active rheumatoid arthritis who have had~     an inadequate response to methotrexate treatment.~   "
26759|NCT02706938|"~     BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and~     nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and~     absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is~     nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains~     unknown due to inconsistent results and methodological limitations among different clinical~     trials, most of which were performed before the widespread use of proton pump inhibitors in~     clinical practice.~      HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal~     reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these~     patients.~      STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of~     patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the~     impact of this intervention in quality of life of these patients.~      METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2~     cross-over design. A sample of 124 patients attending to the outpatient gastroenterology~     unit at Clínica Fundadores in Bogotá city, who meet the inclusion criteria and have no~     exclusion criteria will be selected to participate. Included patients will be randomized to~     raise the head of bed with standard 20 cm-height wooden blocks or to sleep without bed~     inclination during the first 6 week period. After a 2 week washout period, allocation will~     be crossed and participants will be followed again during a second 6 week period. During the~     trial, every patient will receive standard pharmacological treatment with a proton pump~     inhibitor and/or sodium alginate. After allocation concealment, the researchers in charge of~     statistical analysis and reporting results will be blinded for the non pharmacological~     intervention under study. Primary outcome is a significant symptom change according to~     Reflux Disease Questionnaire (RDQ) validated form. Secondary outcomes include impact on~     quality of life according to Short Form 36 (SF-36) validated questionnaire, patient~     preference and adverse events of non-pharmacological intervention. Statistical analysis will~     be carried out with the Statistical Package for Social Sciences (SPSS) 16.0 for Windows.~     Differences with a p<0,05 will be accepted as statistically significant.~   "
26760|NCT02706925|"~     To investigate safety, tolerability and pharmacokinetics, following single doses of BI~     443651~   "
26761|NCT02706912|"~     Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking,~     commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in~     a computer-based virtual world in which stroke patients practice activities of daily living~     (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE)~     motor recovery and assesses system usability and user acceptance.~   "
26762|NCT02706899|"~     This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A;~     33A) and azacitidine in subjects with previously untreated International Prognostic Scoring~     System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).~   "
26763|NCT02706886|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single- and multiple-ascending doses of ALN-GO1 in healthy adult~     volunteers and subjects with PH1.~   "
26764|NCT02706873|"~     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)~     monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis~   "
26765|NCT02706860|"~     This study aims at comparing different perioperative statin regimens for the prevention of~     post CABG adverse events.~      This was a randomized, prospective clinical trial. Ninety four patients scheduled for~     elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment~     groups; 80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for~     5-9 days preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29).~     The corresponding preoperative doses were restarted postoperatively (post-op) when patients~     were able to take the medication orally and were continued for one month. Cardiac troponin I~     (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and~     post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the~     three groups. The incidence of post-operative major adverse cardiac and cerebrovascular~     events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction,~     atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and~     target-vessel revascularization. The incidence of renal or hepatic impairment and~     post-operative infections were also assessed. A Quality of life (QoL) questionnaire~     (EQ-5D-3L) was administered preoperatively and 1 month after CABG.~   "
26766|NCT02706847|"~     The comparison of safety and efficacy of two doses of ABT-494 versus placebo in participants~     with rheumatoid arthritis on a stable background conventional synthetic Disease Modifying~     Anti-Rheumatic Drug (csDMARD).~   "
26767|NCT02706834|"~     The purpose of this study is to evaluate the safety and tolerability of single oral doses of~     TAK-828 in healthy non-Japanese and Japanese participants.~   "
26769|NCT02706808|"~     The objective of this study is to assess whether supplementation with resistant starch from~     the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized~     product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with~     CKD ( both patients under conservative treatment, such as dialysis treatment), as well as~     exerting a beneficial effect with respect to reducing levels of inflammatory markers of~     oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.~   "
26770|NCT02706795|"~     This is an open-label, dose-escalation study to assess the safety and preliminary efficacy~     of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).~   "
26771|NCT02706782|"~     Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery~     is the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic~     cancer patients，when surgery is not available，chemotherapy combined with radiation therapy~     or interventional therapy is commonly used in the treatment，but the prolonging survival~     effect is not obvious. And now, some clinical researchers use CAR-T cells in the treatment~     of pancreatic carcinoma, according to the existing results, therapeutic effects are not as~     good as expecting. One of the most likely reasons is that they continued to use the~     intravenous infusing of CART cells to patients, when the T cells into the blood circulation,~     will result in decreased tumor activity and more potential adverse effects. We believe that~     a suitable TAA targeted-CAR-T cells will be an effective way to treat cancer, as long as the~     pathway of the cell infused to the body can not only improve the drug concentration of the~     tumor site but reduce the potential off-target side effects. In order to achieve this goal,~     it is probably the best choice to use vascular intervention to mediate CAR-T cells infusion.~     Mesothelin is a cell-surface antigen implicated in tumor invasion, which is highly expressed~     in pancreatic carcinoma but low-level expressed in mesothelia. We design a 2nd CART cells~     targeted with mesothelin, and use vascular intervention mediated CAR-T infusion to patients.~     We hope deliver anti-mesothelin CART cells locally can reducing the side effects while~     enhancing the antitumor affect by more CART cells accumulate in tumor sites while less can~     reach normal mesothelial tissue.~   "
26772|NCT02706769|"~     National guidelines advocate the use of paracetamol in conjunction with strong opioids for~     cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the~     analgesic benefit of paracetamol in this large patient group. The investigators aim to~     establish if paracetamol in combination with strong opioids provides superior analgesia for~     cancer related pain over strong opioids alone.~   "
26773|NCT02706756|"~     1. Purpose: 1) compare three conservative treatment approaches for subjects with~          femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome~          comparatively across groups.~        2. Interventions will be provided based on randomized assignment. Group 1 will receive~          treatment based on identified impairments and treated twice weekly to address said~          impairments with hip manual therapy and exercise, as well as a prescriptive exercise~          for strengthening and mobility of the hip. Group 2 will receive only the prescriptive~          exercise program. Group 3 will be a control group (supervised neglect)~        3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA~          for assessment of the primary outcome measure of the HAGOS. Secondary analyses will~          include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs,~          and expectations measures), or other appropriate comparative measures. None of the~          proposed treatment is considered outside of 'standard of practice'.~   "
26774|NCT02706743|"~     The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the~     quality of life(QOL) in differentiated thyroid cancer patients and to identify independent~     factors affecting changes in the QOL.~   "
26775|NCT02706730|"~     This is an open-label extension study of a single intratympanic injection of OTO-104 given~     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy~     study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in~     order to be eligible for this open-label extension study.~   "
26776|NCT02706717|"~     The purpose of the study is to evaluate whether the probiotic Visbiome Extra Strength~     reduces inflammation in HIV-infected men and women when compared to a placebo (inactive~     medication like a dummy pill). The study will evaluate whether taking Visbiome Extra~     Strength by mouth for 24 weeks is safe and well-tolerated for HIV-infected persons on~     antiretroviral therapy (ART). Probiotics are germs such as yeast or bacteria that are found~     in food and supplements that are used to improve the health of the digestive system. Many~     people refer to probiotics as helpful bacteria. These bacteria live in the body and help~     the body work normally. In some medical conditions, including HIV infection, helpful~     bacteria are replaced with bacteria that can change the normal intestinal function and~     increase inflammation. The investigaors will test whether giving a probiotic can restore~     normal intestinal function and decrease inflammation.~   "
26777|NCT02706704|"~     The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg)~     adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration,~     given at zero, 2 weeks then every four weeks, in subjects with active non-infectious~     intermediate-, posterior-, or pan-uveitis.~   "
26778|NCT02706691|"~     This phase IIa proof-of-concept open-label trial will consist of two cohorts namely, HPV(+)~     and HPV(-) and will be run across multiple centers through the University of Chicago PCC~     Consortium. All eligible patients with histologically-confirmed recurrent/metastatic HNSCC~     and FGFR alteration will receive BGJ398 at 125 mg PO daily. Patients with FGFR1-3 high level~     amplification, mutation, or translocation will be included.~   "
26779|NCT02706678|"~     The objective of this study is to evaluate the effects of tacrolimus sustained-release~     capsules replacing cyclosporin on kidney function of renal transplant recipients.~   "
26780|NCT02706665|"~     The purpose of this study is the evaluation of possible relationships and correlation~     between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol~     during general anesthesia.~   "
26789|NCT02706548|"~     Many persons with chronic health conditions fail to take their medications as prescribed,~     resulting in declines in health and function. Unfortunately, current interventions for~     medication nonadherence are not very effective. This objective of this study is to test a~     new intervention, the Integrative Medication Self-management (IMedS) intervention to improve~     medication adherence in adults with chronic health conditions.~   "
26781|NCT02706652|"~     Background:~      People's genetic markers and other genetic characteristics can affect their response to drug~     therapy. Researchers want to screen people for these markers and characteristics. They want~     to do this before the people are screened for studies at the National Cancer Institute. That~     should save time that can be lost when people go through the whole screening for a study~     only to find out they cannot join. The data collected may also be used to select the proper~     dose of anticancer agents that are being studied.~      Objective:~      To screen people for genetic markers and/or baseline characteristics. These will be used to~     determine if they can enroll in a clinical trial. They may also be used to select the proper~     dose of anticancer agents that are being tested.~      Eligibility:~      Adults 18 and older who are being considered for or being treated in a National Cancer~     Institute study~      Design:~      Participants will have their blood drawn for genetic tests.~      Some participants will have a cheek swab.~      Participants genetic data will be stored for future research. It could be shared with other~     researchers....~   "
26782|NCT02706639|"~     Background:~      DNA tells the body how to grow and function. Williams-Beuren syndrome (WS) and Supravalvular~     Aortic Stenosis (SVAS) are rare diseases caused by changes in a part of a person s DNA.~     Symptoms of both conditions include vascular problems including narrow blood vessels and~     supravalvular aortic stenosis (SVAS) or supravalvular pulmonary stenosis. Individuals with~     WS may also have developmental challenges and personality differences. Researchers at the~     NIH want to find out why only some people with WS and SVAS have severe symptoms. They want~     to collect samples and data to see what DNA or environmental changes affect the severity of~     the disease.~      Objective:~      To identify the DNA differences or environmental changes that change the severity of WS and~     SVAS from person to person.~      Eligibility:~      People ages 0 85 with either WS, SVAS, and/or an SVAS-like condition~      Children and people with WS must have a parent or legal guardian to consent or help answer~     questions.~      Design:~      Participants will be screened with questions and medical history.~      Participants will have a 60-minute visit. They will provide blood or saliva samples.~      They or their parent/guardian will:~      Answer questions about how WS and SVAS affect them.~      Sign a form releasing their medical records for the study.~      If participant s regular doctor recommends surgery, researchers will ask the surgeon for~     skin or tissue samples that they might otherwise discard. These will be used to create stem~     cells to study in a lab.~      For up to 20 years, participants will have annual questionnaires by phone, email, or mail~     about their WS or SVAS.~      Participants may also be contacted if:~      They need to provide a new blood or saliva sample.~      Researchers need any other data.~      There is a follow-up study.~   "
26783|NCT02706626|"~     The purpose of this study is to evaluate the safety and effectiveness of this~     investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung~     cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer~     and it still got worse, even after, or while taking drugs called ALK inhibitors, or~     anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are:~     KEYTRUDA® or ALECENSA®).~   "
26784|NCT02706613|"~     Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive~     symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise.~     Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and~     is a structured programme of exercise training and education. Pulmonary Rehabilitation~     encourages and enables patients to improve their exercise capacity incrementally over the~     course of a six-week programme. An established evidence base has placed PR at the centre of~     interventions for COPD and its provision is mandated by NICE as a key pillar of integrated~     care.~      Currently, the provision of PR in the NHS is limited to group sessions run over an~     established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise~     capacity, access to PR classes can be problematic for some patients. Also, staff and~     facility resources limit delivering the programme at scale. An online PR programme developed~     by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts,~     offers an alternative provision of this important intervention.~      The study aims to compare this online PR programme to conventional face-to-face PR as~     currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from~     Portsmouth Hospital and local Participant Identification Centres.They will then be assessed~     for suitability onto PR, consented and randomised onto an arm of the study. 36 will~     undertake a conventional PR programme as reflected in the NHS, and 70 the online PR~     programme known as 'myPR'. Pre and post programme measurements including walking distance~     and quality of life questionnaires will then be compared between each arm of the trial, to~     ensure that the online PR is not inferior to the conventional face-to-face PR.~   "
26785|NCT02706600|"~     There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive~     Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms~     such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute~     for Health and Care Excellence (NICE) recommends that patients with COPD have a self~     management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare~     utilisation, improve quality of life, and reduces the need for hospitalisation. Currently~     SMP's are delivered to patient in a paper format, myCOPD is a web based self management~     system which has been developed by Healthcare professional and patients encompasses the~     principles of Self management and offers a viable solution to a national recommendation.~      The study will compare paper self management plans against the online version myCOPD. The~     study aims to recruit 60 patients with a diagnosis of COPD during their admission to~     hospital for an exacerbation or flare up of their COPD. Patients will be given an~     information sheet during their admission and prior to leaving hospital be asked if they wish~     to participate in the study. Patients will participate in the study for no less than two~     months and a maximum of three months. 30 patients will receive written self management and~     30 will receive online self management. There will be a total of 4 visits for the duration~     of the study.~      The screening visits will comprise of written or verbal consent, Demographics, Medical,~     exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler~     technique assessment and delivery of either a written self management plan. The telephone~     visits will comprise of verbal consent and completion of the COPD Assessment Test. The End~     of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and~     healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler~     technique.~   "
26786|NCT02706587|"~     The purpose of this study is to determine whether early neuromuscular electrical stimulation~     is effective in the prevention of neuromuscular weakness in critical ill patients.~   "
26787|NCT02706574|"~     The goals of this study are to develop an objective, multi-modal classification scheme and~     outcome measures for traumatic brain injury based on several measures: (1) blood-based~     biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass~     effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of~     CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.~   "
26788|NCT02706561|"~     The purpose of this study is to test two different ways to help men with sexual~     rehabilitation.~   "
26790|NCT02706535|"~     This is a Phase I, single center, two-part, randomized, open label, cross-over study. Part 1~     of this study will evaluate the PK, safety, and tolerability of GSK525762 when administered~     alone and when co-administered following repeat dosing of itraconazole, a known strong~     inhibitor of Cytochrome P450 3A4 (CYP3A4) and a Para-glycoprotein (Pgp) inhibitor. Part 1~     will consist of 2 Cohorts with preliminary PK and safety data obtained from Cohort 1~     informing Cohort 2. Part 2 (one Cohort) of the study will evaluate the PK, safety, and~     tolerability of GSK525762 when administered alone and when co-administered following repeat~     dosing of rifampicin, a known potent inducer of CYP3A4. In vitro inhibition data indicate~     CYP3A4 may be the major route of clearance for GSK525762 and co-administration of drug~     therapies which modulate CYP3A4 (i.e.CYP3A4 inhibitors and inducers) is likely to alter the~     exposure of GSK525762 (i.e. increase or decrease exposure, respectively). The data generated~     from this current study to justify exclusion criteria on concomitant medications which~     affect CYP3A4 or Pgp and also inform potential dose modification in case of~     co-administration with medication affecting CYP3A4 activity. All subjects will undergo a~     screening visit within 28 days of the first dose of study drug followed by one treatment~     period and a follow-up visit 7-10 days after the last dose of GSK525762. Subjects in Part 1~     will participate in the study for up to 45 days and subjects in Part 2 will participate for~     up to 56 days.~   "
26791|NCT02706522|"~     This study is to evaluate the effects of preoperative carbohydrate intake on perioperative~     neuroinflammation and development of delirium.~   "
26792|NCT02706509|"~     A multicenter prospective interventional comparative study that investigate pain management~     during Jaydess insertion in nulliparous women that will be tested by the analgesic affects~     of oral tramadol or 'verbal anesthesia' on the patients.~   "
26793|NCT02706496|"~     With aging, the elderly decreased ability to control postural balance will be accompanied by~     increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous~     studies, it showed that the elderly over 65 years fall each year probability was 30 %, and~     it increased with age (Skelton, & Todd, 2004). In view of this, age-related posture control~     has become important issues of modern preventive medicine and family care.~   "
26794|NCT02706483|"~     Multi-center, open-label, long-term safety study~   "
26795|NCT02706470|"~     The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant~     drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of~     unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an~     active comparator. The hypothesis is based on the evidence found in vitro and in vivo~     experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of~     miscarriage.~   "
26796|NCT02706457|"~     Barthel Index and demographic variables of patients were collected to investigate the~     question whether the improvements of the functionality improves the Barthel Index over the~     years.~   "
26797|NCT02706444|"~     To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis~     graft, investigators would like to perform randomized study comparing the results of drug-~     coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous~     anastomotic stenosis of AVG in terms of patency.~   "
26798|NCT02706431|"~     Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a~     limited number of studies. Although data are convincing it is of importance to evaluate this~     new concept in our department before implementing it into clinical practice.~      The general purpose of this project is to evaluate a new ventilation strategy during~     ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on~     gas exchange.~   "
26799|NCT02706418|"~     Once participants have been recruited, their grip strength shall be tested and they will all~     complete baseline questionnaires to assess functional status and symptom severity.~      Following the recruitment stage, participants will be asked to attend Medway Maritime~     Hospital once a week for four weeks, to receive the massage protocol. At the first session~     participants shall be asked to rate their pain (NPRS), before receiving a massage treatment.~     This will be followed by instructions on how to perform self-massage, which they will be~     asked to complete daily over the four-week period, and record in a diary. At the remaining~     three sessions, participants shall just complete the NPRS prior to receiving the massage~     treatment.~      After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended~     prior to recruitment. They will be asked to complete a final pain score, record any changes~     in their condition, repeat the initial symptom questionnaire, and finally preform a grip~     strength test. The duration of four weeks was chosen as this is the time-frame within which~     the specific massage protocol advises a 'significant symptom improvement' should be seen.~   "
26800|NCT02706405|"~     This phase Ib trial studies whether anti-cluster of differentiation (CD)19-chimeric antigen~     receptor (CAR) lentiviral vector-transduced autologous T cells (JCAR014) and durvalumab are~     safe in combination and can work together in treating patients with non-Hodgkin lymphoma~     that has returned after a period of improvement or has not responded to previous treatment.~     JCAR014 is made of patients' immune cells (T cells) that have a new gene added to them in a~     laboratory, which programs them to kill lymphoma cells. Durvalumab is a type of drug called~     a monoclonal antibody, targeted to PD-L1 that may help immune cells attack cancer cells more~     effectively and thus help JCAR014 work better.~   "
26801|NCT02706392|"~     This phase I trial studies the side effects and best dose of genetically modified T-cell~     therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive~     (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic~     leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast~     cancer (TNBC) that has spread to other places in the body and usually cannot be cured or~     controlled with treatment (advanced). Genetically modified therapies, such as ROR1 specific~     chimeric antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the~     laboratory so they specifically may kill cancer cells with a protein called ROR1 on their~     surfaces, and safely given back to the patient after conventional therapy. The genetically~     modified T-cells have genes added in the laboratory to make them recognize ROR1.~   "
26856|NCT02705664|"~     The main objective of this study is to compare subject adherence and satisfaction for two~     modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL)~     and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1%~     (Bifonazole).~   "
26802|NCT02706379|"~     Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock,~     which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality~     of patients with septic shock and improve the prognosis of patients with EGDT. However, in~     recent years, the standard of EGDT to determine the existence of the target of septic shock.~     Some studies have shown that there may be a manifestation of the deficiency of kidney and~     liver and other organs such as kidney, liver and other organs in the recovery of EGDT.~     Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when~     the target is reached.The aim of this study was to investigate the effects of EGDT as a~     guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the~     treatment of fluid resuscitation in patients with septic shock.~   "
26803|NCT02706353|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     APX005M that can be given with pembrolizumab that can be given to patients with metastatic~     melanoma.~      The goal of Part 2 of this study is to learn if the combination can help to control~     metastatic melanoma.~      The safety of this drug combination will also be studied.~   "
26804|NCT02706340|"~     This is an observational study enrolling women who have had a copper intrauterine device~     placed immediately after childbirth. The study follows participants for 6 month in order to~     evaluate the primary outcome of IUD expulsion within 6 months of delivery.~   "
26805|NCT02706327|"~     The purpose of this study is to compare computer aided design/computer aided manufacturing~     (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and~     also to decide whether they are necessary in treatment of painful flexible flatfoot.~   "
26806|NCT02706314|"~     Critical illness in the ICU setting has high medical and socioeconomic importance.~     Critically ill patients frequently develop severe neurologic impairment during their course~     of disease, typically presenting as critical-illness-polyneuropathy (CIP), which is~     associated with an increased mortality rate. To date neither strategies are available to~     predict nor to specifically treat CIP.~      Diagnostic tests to determine CIP during the course of critical illness are available~     through nerve conduction studies. Further research is needed to find diagnostic tools to~     identify patients who are on high risk to develop CIP, which could encourage the evolution~     of new therapeutic strategies for CIP patients.~      The aims of the study are:~        1. An early detection of changes in intramural neuronal networks of human colon samples~          induced by human blood serum from critically ill patients in order to predict the~          development of CIP~        2. The comparison of different diagnostic tests to diagnose and monitor CIP during the~          course of critical illness (neurologic examination versus nerve conduction study versus~          neuromyosonography)~   "
26807|NCT02706301|"~     Colorectal cancer survivors experience long-term negative physical and psychosocial~     consequences of their disease. There is a critical need to develop novel behavioral~     interventions for improving colorectal cancer survivor outcomes. The investigators have~     developed a pain management intervention for colorectal cancer survivors that focuses on~     addressing both pain and psychological distress. Colorectal cancer survivors who endorse~     pain and comorbid psychological distress as a concern during a clinic-based survivorship~     care consult will be recruited. Participants will be randomized into either: Telephone-Based~     Coping Skills Training (CST) for pain and comorbid psychological distress or standard care.~     The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that~     teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring)~     relevant to managing pain and psychological distress. The standard care control condition~     will receive resources and referrals related to managing survivorship health.~   "
26808|NCT02706288|"~     The purpose of this study is to understand how weight loss by a very low fat plant-based~     diet with an exercise program affects metabolic and cardiovascular health in overweight~     adults at high risk for disease. Outcome measures will include assessment of insulin~     sensitivity, β-cell function, body fat distribution, skeletal muscle and adipose tissue~     biology, cardiovascular function, cardiorespiratory fitness, muscular strength, immune~     function, and the gut microbiome.~   "
26809|NCT02706275|"~     The purpose of this study is to determine whether externally warming critically ill afebrile~     adult septic patients will improve indices of immune function and/or clinical outcomes.~   "
26810|NCT02706262|"~     The purpose of this research study is to 1) understand how some, but not all people with~     obesity develop obesity related conditions such as type 2 diabetes and cardiovascular~     disease, and 2) compare the effects of 3 popular weight loss diets (Mediterranean,~     low-carbohydrate, or a very-low-fat plant-based diet) in people with obesity.~   "
26811|NCT02706249|"~     Hospitalized patients with histologically or cytologically confirmed diagnosis of solid~     tumor malignancy or lymphoma and who are at high risk for a venous thromboembolisn will be~     randomized to standard dose versus intermediate dose enoxaparin.~   "
26812|NCT02706236|"~     The study purpose is to characterize the effect of pancreatic enzyme supplementation on~     chronic pancreatitis type pain.~   "
26813|NCT02706223|"~     Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of~     the population infected. At best, 25% of those infected will clear the infection~     spontaneously, though for those who develop a chronic infection, they may go onto to develop~     liver cirrhosis or liver cancers.~      The standard of care within the NHS is that patients with a history of intravenous drug use~     or those currently on methadone are at high risk of having HCV infection and should be~     offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways.~     Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go~     onto treatment regimens that successfully clear the infection despite regular interactions~     with heath care staff.~      Pharmacists who have daily interactions with patients receiving methadone are ideally placed~     to deliver anti HCV therapy as they have daily contact with this client group and are well~     placed to advise on the drug therapy.~      The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT)~     for HCV treatment in patients attending Community Pharmacies in participating Health Boards~     within NHS Scotland. The impact of this approach will be compared with those referred to~     standard care pathways on how well participants clear their HCV infection.~   "
40734|NCT02523820|"~     The purpose of this study is to evaluate the efficacy and adverse effect of nebulized~     corticosteroid to prevent post-extubation stridor in children.~   "
26814|NCT02706210|"~     Dementia is one of the main chronic non-communicable diseases associated with disability,~     institutionalization, and mortality among elderly individuals. Alzheimer's disease (AD) and~     vascular dementia (VD) are considered to be the main types of dementia. A widely shared view~     is that future treatment strategies need to focus on treatment of the earliest stages of the~     disease. Mild cognitive impairment (MCI) constitutes an intermediate stage between normal~     aging and dementia. Vascular cognitive disorders (VCD) is an umbrella term representing a~     wide spectrum of cognitive disorder evoked by or associated with vascular causes. It~     encompasses patients suffering from a range of types of cognitive impairment, from mild~     impairment to VD. VCD predementia (VCD-P) is at the same stage of MCI. Amnestic MCI (aMCI)~     is a subtype of MCI, which is also considered to be the clinical transition stage between~     normal aging and AD, and has been applied to detect the emerging dementia. In VCD, infarcts~     or profuse white matter disease are considered the cause of cognitive decline. By contrast,~     AD is one of the most common progressive neurodegenerative disorders thought to be caused by~     amyloid aggregation and the formation of tau tangles. Both VCD-P and aMCI have a deficit in~     cognitive domains, and may have the same chief complaints of memory deficit. If it can be~     clear which will turn into what type of dementia in patients with cognitive impairment~     stage, it can not only make us more early intervention treatment to the patients, but also~     can save a lot of social resources and economic costs in clinic. By applying the resting~     state functional magnetic resonance (fMRI), structural magnetic resonance imaging (sMRI) and~     diffusion tensor magnetic resonance imaging (DTI) multimodal magnetic resonance (NMR)~     technology, the project comprehensive analysis comparison of neurodegenerative and blood~     vessels of brain function in patients with mild cognitive impairment and structural~     abnormalities connection mode. This project in order to reveal the cognitive impairment~     disease neural circuits in the development of the network connection and its change rule.~     People can further understand the pathogenesis of cognitive impairment, discover new will~     provide a scientific basis for prevention, diagnosis and treatment.~   "
26815|NCT02706197|"~     Tumors with low oxygen levels are associated with poor prognosis and resistance to standard~     radiotherapy or chemotherapy. The ability to make repeated oxygen measurements in tumors~     could be used to help select the most effective treatment or the best timing to start~     therapies. The purpose of this study is to ascertain the safety and feasibility of using an~     implantable oxygen sensor, known as the OxyChip, to make oxygen measurements in tumors using~     EPR oximetry, a technique related to magnetic resonance imaging (MRI).~   "
26816|NCT02706184|"~     In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in~     combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is~     planned, it shall be investigated whether E. coli Nissle suspension has an effect on~     duration and intensity of chemotherapy induced diarrhea.~   "
26817|NCT02706171|"~     This study is evaluating treatment with CyberKnife for soft tissue sarcomas.~   "
26818|NCT02706158|"~     Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and~     mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors~     and dietary status have been suggested to play a role in development of preeclampsia. Low~     intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related~     to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6:~     omega 3 ratio and high calories consumption are possible risk factors.~      Material and Methods: A prospective study will be carried out. Woman medically diagnosed as~     high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary~     treatment groups. In the dietary treatment group, besides medical care, all woman will get~     calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter~     until delivery personal extensive nutritional guidance. A 3 day food diary will be collected~     at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data~     during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be~     documented.~      In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine~     will be recorded.~   "
26819|NCT02706145|"~     The project will utilize a quasi-experimental design to examine the effectiveness of a~     community-level, three-year social norming campaign aimed at changing norms of violence~     among youth 10-24, with West Louisville (WL) as the intervention community and East~     Nashville, Tennessee as the control community. The project will address the following~     research questions (RQs):~      RQ1: To what extent is a social norming campaign effective in changing the descriptive and~     injunctive norms of violence among youth in WL?~      RQ2: To what extent are the descriptive and injunctive norms of violence among youth in WL~     related to violent behavior (by type)?~      RQ3: To what extent is a social norming campaign effective in reducing population rates of~     youth violence in WL?~      RQ4: Which forms of media are most effective in reaching youth of different ages with~     campaign messages?~      RQ5: How is community readiness related to implementation of a community-level social~     norming campaign?~      RQ6: How is community capacity related to implementation of a community-level social norming~     campaign?~      RQ7: How does community capacity to address youth violence change over time with the~     implementation of a community-level social norming campaign?~      RQ8: To what extent is a social norming campaign cost-effective in reducing incidents of~     serious violence among youth?~   "
26820|NCT02706132|"~     The purpose of this study is to determine whether MSCs are safe and effective in reducing~     the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs)~     morbidity in ABO-incompatible Liver Transplantation.~   "
26821|NCT02706119|"~     Analyze the level of metabolic control achieved with a routine of regular insulin in the~     parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus~     only regular insulin in the PN reservoir.~   "
26822|NCT02706106|"~     It is a controlled clinical trial randomized, double-blind evaluator. Will be considered~     eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of~     knee osteoarthrosis classification criteria, according to the American College of~     Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee~     osteoarthritis and who sought physical therapy treatment.~      Patients will be randomized by a number sequence generated by a computer using Microsoft~     Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who~     will not attend the study.Patients will be divided into two groups: group with knee patellar~     hole or group without knee patellar hole. Shortly after the selection of the knee, the~     patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type~     of knee brace that it would use.~      Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator~     ''blind '' regarding the type of knee brace that will be used.~      Two investigators will carry out the data collection. The first evaluator will collect~     information on the clinical characteristics of patients, including evaluation form,~     numerical pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test~     that measures the basic mobility of movement and test walking eight meters, whose purpose is~     to measure the time that the individual takes to walk a distance of eight meters.~   "
26823|NCT02706093|"~     The overall objectives are to:~        1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the~          whole-body, tissue, and cellular levels.~        2. Systematically compare different HIIT regimens to help identify effective doses of~          HIIT that may be optimal for improving metabolic health in obese adults.~        3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.~      Findings from these studies will greatly expand knowledge about the effects of HIIT on~     metabolic health, and will provide valuable information for development of programs aimed at~     maximizing key metabolic benefits of exercise.~   "
26824|NCT02706080|"~     Antithrombotics with antiplatelet agents, vitamin K antagonist (VKA), heparin and related~     substances, and new oral anticoagulants are prescribed for arterial diseases, especially in~     secondary prevention of embolic disease in carrier patients of heart valves and in patients~     with fibrillation atrial, and venous diseases, in prevention and treatment.~      The prescription of these treatments is increasing especially in older patients associated~     with many comorbidities. Today, an estimated number of 900 000 patients under anti-vitamin K~     in France, and more than 1.5 million for patients on antiplatelet agents.~      Venous thromboembolism (VTE) is common in the general population with an annual incidence of~     10-18 cases per 10 000. The most severe form of VTE is represented by pulmonary embolism~     with a third of cases. Even if a large literature allows for high grade recommendations on~     many areas, there is still some gray areas regarding the long-term outcomes, the early~     evolution and tolerance of treatment, including long-term recurrence, the incidence of~     embolic sequelae with post-embolic pulmonary hypertension and association with other~     cardiovascular arterial accident (acute Coronary Syndrome, Stroke, arterial disease of the~     Lower Extremities ...).~      The major risk of these antithrombotic is bleeding both in terms of morbidity mortality.~     Despite this risk, little study focuses on the exact epidemiology of bleeding associated~     with the use of antithrombotic. If the frequency of hemorrhagic stroke is low, some~     populations particularly at risk of bleeding represent the majority of serious bleeding~     events under VKA or anti-platelet. However, the VKA and antiplatelet agents are the first~     providers of hemorrhagic serious side effects drugs when looking at all national and~     international studies on the iatrogenic with in topped gastrointestinal bleeding and~     intracerebral hemorrhage (mortality of about 10 to 15%).~      Moreover the recent arrival of new oral anticoagulants (Apixaban rivaroxaban, dabigatran~     ...) should profoundly change the management of venous thromboembolism and cardioembolic~     event. Because of their risk-benefit, simplicity and convenience of their prescription, the~     number of patients treated with these new anticoagulants were to rise rapidly. In addition,~     many patients deemed too fragile to be treated with VKA, should be treated with these~     treatments. These new anti-Xa and anti-IIa anticoagulants already marketed or about to be.~     They have the advantage over VKA: an oral way, their pharmacokinetic characteristics,~     absence of biological monitoring, chemical synthesis .... If it is not possible today to~     give the advantage to one or the other of these molecules, the choice will be directed by~     their pharmacokinetic characteristics, their half life, their method of disposal but also by~     patients co-morbidities. Although biological tests are currently available for the~     monitoring of these products, therapeutic solutions for severe bleeding does not exist:~     there is indeed no antidote for now, though the issue is finding a balance between increased~     therapeutic benefit and bleeding risk optimization. But hemorrhagic stroke is the most~     serious complications of oral anticoagulant therapy, with substantial documentation for~     these events occurring under VKA but little data on those occurring with the new oral~     anticoagulants (Apixaban rivaroxaban, dabigatran ...).~   "
26825|NCT02706067|"~     This study will evaluate the efficacy of a multifactorial approach associated with orlistat~     (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination~     with diet, physical activity, and/or cognitive behavioral therapy will be monitored.~   "
26826|NCT02706054|"~     This randomized, double-blind, placebo control, cross-over study tested the hypothesis that~     periradicular injections of Meloxicam would reduce recent onset low back pain and improve~     physical activity compared to saline injection at 3 months follow-up evaluation~   "
26827|NCT02706041|"~     Randomized study to compare outcomes of patients undergoing damage control laparotomies~     versus definitive closure for which there is surgeon equipoise to randomize.~   "
26828|NCT02706028|"~     In this randomized, double-blind, placebo-controlled study the effects of underwater~     ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid~     arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).~      Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound~     therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2~     during 10 sessions. The control group (N=23) received sham treatment under the same~     conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week~     14), the following parameters were evaluated: disease activity - erythrocyte sedimentation~     rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual~     analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand~     grip strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients~     rated their own condition.~   "
26829|NCT02706015|"~     This study evaluates the non-inferiority of Cefaliv® compared to Neosaldina® in the~     treatment of migraine attack in two hundred and sixteen adults of both sexes with age~     between eighteen and sixty five years old. The first Half of participants will receive~     Cefaliv®, the other half will receive Neosaldina®.~   "
26830|NCT02706002|"~     Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality.~     Because conventional templating has a high mismatch rate, the investigators sought to~     explore whether the investigators could use intraoperative fluoroscopy while implanting the~     femoral stem.~   "
26831|NCT02705989|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,~     and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in~     healthy subjects, and to assess the relative bioavailability of two formulations of~     BMS-986195 with or without food.~   "
26832|NCT02705976|"~     The aim of this study is to perform a randomized trial comparing the use of the algorithm,~     with dosing of warfarin in standard manual dosage clinical practice, in a high quality~     anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance~     of the algorithm when used in a clinical setup. The results from the study are expected to~     increase our knowledge of efficacy by using the algorithm in clinical practice.~   "
26833|NCT02705963|"~     The purpose of this study is to evaluate the effect of trametinib once daily on the~     pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone~     (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib~     and its metabolite M5 will also be assessed.~   "
26834|NCT02705950|"~     Hypothesis:~      ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury~     patients, which could depend on the subtype of pain, or on the lesion level, cervical or~     thoracic spinal cord injury.~      Objective:~      To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with~     spinal cord injury at cervico-dorsal level.~      Primary Endpoint:~      Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic~     Pain Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal~     cord injury at cervico-dorsal level.~      Secondary Endpoints:~        1. Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual~          Analogue Scale and Penn Spasm Frequency Scale).~        2. Neurophysiological examination (warm perception threshold, heat pain perception~          threshold, evoked pain perception and contact heat evoked potentials).~   "
26835|NCT02705937|"~     Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva~     substitutes are disappointing (bad taste, poor efficiency).~      The hypothesis stems from the empirical observations that many patients alleviate dry~     mouth symptoms by the consumption of dairy products. Through its composition, the dairy~     product in itself provides relief for the patient, due both to its physical and biochemical~     properties, which could explain these observed improvements, and to elements related to the~     phenomena of consumption of food as an alternative to medication. In the latter case,~     hedonism takes on a role which has not been previously assessed. Initial work undertaken~     with the department of applied research at the National Dairy Industry School (ENIL) led to~     the prototyping of a new milk product, to qualify and adapt a product with a health~     benefit in patients suffering from xerostomia.~      This dairy product has specific taste, texture and lubrication properties and will be tested~     in a randomized controlled cross-over study for its efficiency and acceptability versus a~     reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at~     Dijon and at Besançon University Hospitals.~      This way of combatting xerostomia at the interface of patients' diet, such as it is proposed~     here, could help improve their quality of life, minimize harmful effects (infection, decay)~     and promote adherence to treatments which are responsible for xerostomia.~   "
26868|NCT02705508|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's~     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the~     efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine~     (PEG) treatment in this population.~   "
26836|NCT02705924|"~     Young female counselees (18-30 years) belonging to HBOC families with a known mutation on~     BRCA-genes or not, receive a lot of information regarding their cancer risk. Information~     sources are numerous and sometimes contradictory. Unfortunately, these women face these~     issues at a key moment of there identity construction (self, relationship, sexuality) while~     they are not yet concerned by health prevention measures. A special psychoeducational~     intervention was designed to help these women to better cope with these difficulties.~      Intervention consists in a week-end session in a thermal center (SPA) during which they will~     attend short conferences given by specialists (prevention measures, prophylactic surgery,~     assisted procreation, epidemiology...) and participate to role games and group sharing.~      Intervention will be evaluated using self-questionnaires completed before intervention and~     during the following year.~   "
26837|NCT02705911|"~     The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the~     training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it~     yields at least similar effects on BP compared to current exercise recommendations.~      II. To assess whether isometric handgrip training yields larger BP reductions beyond the~     supervised training period at 6 months of follow-up.~      III. To determine whether changes in BP following acute exercise and chronic training can be~     explained by changes in important physiological mechanisms known to mediate or to be~     associated with BP?~   "
26838|NCT02705898|"~     Building on the large body of evidence for the effect of exercise in decreasing depressive~     symptoms and the few preliminary findings of its effect on craving and drinking outcomes,~     the purpose of this study is to develop a lifestyle physical activity (LPA) intervention~     that harnesses the technological advantages of the Fitbit tracker (plus its web and mobile~     platforms) for depressed women with alcohol use disorders (AUDs). The intervention will~     provide women with an acceptable, flexible and effective alternate coping strategy during~     early recovery, when relapse risk is highest. The overall objective of this work is to fully~     develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to~     ensure its feasibility and acceptability for depressed women with AUDs in early recovery,~     propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.~   "
26839|NCT02705885|"~     Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a~     food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas~     gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8~     weeks the patients were examined against. Parameters including probing depth (PD), bleeding~     on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared~     to the control group that had used placebo lozenges.~   "
26840|NCT02705872|"~     The epidural has been recognized for many years as the most effective analgesia method for~     obstetrical labor. Several different administration protocols have been evaluated over the~     years with the aim of reducing side effects.~      Epidurals have been incriminated in the increase of instrumented births. It is indeed~     possible that the motor block induced by the epidural reduces the pelvic tonus and the~     ability of the mother to push during the second stage of the labor. Furthermore, this motor~     block might lead to a ill rotation of the foetal head within the pelvis, which could lead to~     instrumentation (suction cups, forceps).~      In the investigator's institution, an ongoing study also provided interim that showed that~     the use of a low concentration of local anesthetics (as opposed to a higher concentration)~     tends to decrease the instrumentation and cesarean sections rate in the institution's~     population.However, the optimal administration mode of the local anesthetic in the epidural~     remains unknown.~      In the last few years, there has been a growing interest for a new method of administration~     of the solution within the epidural, by programmed intermittent bolus. This method allows a~     better distribution of the local anesthetics in the epidural space, compared to a continuous~     perfusion.~      This study therefore focuses on the relationship between the use of epidural with programmed~     intermittent boluses and the rate of instrumented deliveries and cesarean sections.~      The exact mode of administration of boluses is also subject to discussion in the literature.~     One can question whether it is preferable to administer smaller boluses more frequently or~     larger less frequent boluses. A few studies have investigated this issue and recommend to~     administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought~     after physiology (ie a wider distribution in the epidural space) and provides equivalent~     analgesia to smaller, more frequent boluses.~   "
26841|NCT02705859|"~     This study is a Phase Ib/II open label, single arm, adaptive multi-centre trial of~     copanlisib in combination with trastuzumab in pretreated recurrent or metastatic~     HER2-positive breast cancer.~      Patients with HER2 positive, metastatic or incurable recurrent breast cancer, following~     disease progression during, or after, treatment with at least one systemic treatment regimen~     in the metastatic or recurrent setting, will be treated with copanlisib (at 30, 45 or 60 mg~     flat dosing IV weekly - depending on the maximum tolerated dose (MTD) determined in the~     Phase Ib part of the study) plus trastuzumab (4 mg/kg IV Cycle 1 Day 1 and then 2 mg/kg IV~     weekly starting from day 8).~   "
26842|NCT02705846|"~     GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer~     predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and~     treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers~     with PCa matched with a control group of men with PCa who are known not to carry a mutation~     in the same gene. Clinical data regarding treatment and patient outcome will be collected~     retrospectively and prospectively. Archived tumour samples will also be collected for tumour~     profiling. A blood or saliva sample will be taken, if the participant consents to this part~     of the study, for genetic profiling to investigate any association of other inherited~     factors with PCa outcomes. Information obtained from this study will be of critical~     importance to support clinical trials investigating the most appropriate management of PCa~     in this group of patients at increased risk of prostate cancer.~   "
26843|NCT02705833|"~     The primary objective of the study is to characterize the medical management of squamous~     cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M)~     disease (between 01July2013 and 30 June 2014) in the real-world setting.~   "
26844|NCT02705820|"~     Single arm one stage Phase II study: post 4-6 cycles platinum doublet chemotherapy for~     patients with metastatic Non Small Cell Lung Cancer (NSCLC) offering Pembrolizumab as~     maintenance therapy to non-progressors with primary endpoint: Immune Related Progression~     Free Survival (irPFS) at 1 year. Aim to show that this is at least 25% (compared to an~     expected 12% 1 year PFS based on the Pemetrexed and Erlotinib maintenance trials).~   "
26869|NCT02705495|"~     In this multi-centre prospective randomized controlled trial the efficacy of segmental~     acupuncture in the prevention of recurrent urinary tract infections will be assessed. The~     study (acupuncture) group will receive 12 acupuncture treatments according to a standardized~     protocol, plus recommendation for use of cranberry products. The control group will receive~     recommendation for use of cranberry products only.~   "
26845|NCT02705807|"~     This study is a Phase IV, open-label, single-arm study to assess the safety and the~     necessity of dose adjustment after switching to FLOLAN injection prepared with the~     reformulated diluent in Japanese patients with PAH who are receiving higher doses of FLOLAN~     injection than in other countries. The objective is to evaluate the safety and tolerability~     of the thermostable formulation of FLOLAN injection (that is [i.e.], FLOLAN injection~     prepared with the reformulated diluent) when switched from the existing FLOLAN injection~     treatment (i.e., FLOLAN injection prepared with the currently marketed diluent). The study~     will include a screening visit, a run-in period of a maximum of 4 weeks with the existing~     FLOLAN treatment (i.e., FLOLAN injection prepared with the currently marketed diluent), a~     4-week treatment period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN~     injection prepared with the reformulated diluent) and a one-week follow-up visit. Adequate~     number of subjects will be enrolled in the study in order to have 10 subjects to complete~     assessments at 4 weeks, including at least 5 subjects as a subset of subjects who consent to~     undergo right heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered~     trademark of the GlaxoSmithKline [GSK] group of companies.~   "
26846|NCT02705794|"~     The study title Clinical trial of comparative evaluation of the Modified Mallampati Score~     and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and~     Cervical mobility (M-TAC) in Predicting Difficult Airway  was undertaken to evaluate~     prediction of difficult airway by comparing preoperative airway evaluation tests.~      Mallampati classification is the most used screening test for detection of difficult~     intubation it is a classification of oropharyngeal view. Other tests include sternomental~     distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of~     mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and~     ultrasonography of neck soft tissue. We studied 200 adult ASA I & II patients of either sex,~     aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.~      Modified mallampati classification had four grades & each grade was given a score, similarly~     thyromental distance (TMD), anatomical abnormality (AA) & cervical mobility (CM) was~     classified into three grades & each grade was given a score. For M-TAC individual scores~     were added.~   "
26847|NCT02705781|"~     This study conducted in order to validate the functionality and accuracy of the smARTrack™~     System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with~     nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit~     real-time information to an external console. The smARTrack™ feeding tube is equipped with~     reflux sensors which alert when gastric contents regurgitating into the esophagus. In~     addition, the smARTrack™ feeding tube is equipped with sensors designed to provide~     information about the location of the tube thus assisting in reducing the incident of~     misplacement during first positioning. The smARTrack™ feeding tube is also automatically and~     in real-time stops feeding if the feeding tube moves out of position during ongoing use or~     detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide~     operator to correctly re-position the tube.~   "
26848|NCT02705768|"~     The present study has been planned to assess the level of serum neuron-specific enolase~     (NSE) in focal seizures and its changes after antiepileptic therapy.~   "
26849|NCT02705755|"~     This multiple-center, randomized, 2-part, single- and double-blind study will be conducted~     in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect~     of TD-9855 in improving symptoms of orthostatic intolerance.~   "
26850|NCT02705742|"~     In this study, investigators aimed to transplant autologous, adipose tissue derived~     mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to~     assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy.~     Finally investigators aimed to establish an alternative treatment modality to liver~     transplantation.~   "
26851|NCT02705729|"~     The purpose of this study is to determine whether two tooth-colored glass ionomer materials~     are effective for load-bearing dental fillings.~   "
26852|NCT02705716|"~     This study will investigate the efficacy of an experimental dentifrice containing 0.454%~     weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice~     daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.~   "
26853|NCT02705703|"~     This study evaluates the effectiveness of Tumor Associated Peptide Antigens (TAPA) pulsed~     dendritic cell injections as a potential consolidation therapy for patients with metastatic~     solid malignancies (SM). The investigators hypothesize that treatment of patients with~     metastatic SM who demonstrate a tumor response, or whose disease remains stable, after~     conventional first-line systemic therapy AND who lack an available, potentially curative~     therapeutic intervention and whose tumor cells and/or blood express at least one (1) TAPA of~     a defined panel of TAPAs will result in TAPA-specific T-cell responses without significant~     toxicities. The investigators also hypothesize CD4+ and CD8+ T-cell responses generated~     against specific TAPAs may translate into clinical antitumor activity.~   "
26854|NCT02705690|"~     This study aims to benchmark the performance of an iOS application against the Berg Balance~     Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring~     balance across the continuum from acute care to community-based care. An iPhone will be tied~     around the waist of the participant and concurrent measurements will be taken for five of~     the fourteen stances which comprise the BBS.~   "
26855|NCT02705677|"~     The overarching purpose of this study is to advance understanding of the natural history of~     Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including~     CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all these~     disorders are the result of specific genetic changes, there remains broad clinical variation~     that is not entirely accounted for by known biological factors. Additionally, clinical~     investigators currently do not have any biomarkers of disease status, clinical severity, or~     responsiveness to therapeutic intervention. To address these issues, biological materials~     (DNA, RNA, plasma, cell lines) will be collected from affected individuals and in some cases~     from unaffected family members, initial evaluation performed to identify additional~     biological factors contributing to disease severity, and these materials will be stored for~     future characterization.~   "
26870|NCT02705482|"~     The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic~     agents in adult subjects with select advanced solid tumors.~   "
26857|NCT02705651|"~     A.Background~      More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple~     pancreatic neuroendocrine tumors (pNETs). These tumors are the most common cause for~     premature death in MEN1.~      While functioning pNETs must be treated to reduce or cure hormonal excess, the procedures~     for non-functioning pNETs are yet under discussion. Treatment ranges from watchful waiting~     to subtotal and total pancreatectomy. The latter may represent an overtreatment, resulting~     in general complications and diabetic metabolic status.~      The effect of somatostatin analogues (SAs) has shown promising results with regard to~     progression of non-functioning duodeno-pancreatic NETs. Treatment with SAs is highly safe~     and effective, resulting in long-time suppression of tumor growth.~      B. Aim~      In this study of MEN1 patients with non-functioning pNETs, the benefits of somatostatin~     analogs (SAs; group 1) compared to no treatment (group 2) will be analyzed with regard to~     progression (tumor growth; development of new [functioning and non-functioning]~     neuroendocrine tumors and regional/distant metastasis).~      C. Implementation~      Patients will either receive Somatostatin Analogs (SAs) or no treatment. The observation~     period will be 60 months. The increase of tumor size and development of new tumors or~     metastasis will be monitored.~   "
26858|NCT02705638|"~     Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who~     have persistent or recurrent disease despite standard therapies, does combination therapy~     with rituximab and revlimid cause a sustained disease remission?~   "
26859|NCT02705625|"~     This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,~     Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients~     with knee osteoarthritis (OA).~   "
26860|NCT02705612|"~     The purpose of this phase II trial is to determine the feasibility and efficacy of~     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable~     locally advanced cervical cancer.~   "
26861|NCT02705599|"~     To explore the stroke mechanism evolution in patients with intracranial atherosclerotic~     stenosis by magnetic resonance imaging(MRI) from current first stroke to follow up stroke~     recurrence. Diffusion weighted imaging was to identify basic stroke mechanism. High~     resolution MRI and perfusion imaging was to monitor the dynamic changes of vulnerable~     atherosclerotic plaque and hemodynamic status including antegrade flow and collateral~     circulation.~   "
26862|NCT02705586|"~     To evaluate the feasibility of a video based mindfulness intervention for stress reduction~     and to evaluate the cortisol response in persons with PD and their caregivers. The data from~     this project will be used for a future grant application of a stress reduction intervention~     in persons with PD.~   "
26863|NCT02705573|"~     In this project we want to evaluate the effect of mannitol on graft function after renal~     transplantation. Due to the unclear situation regarding data of Mannitoleffect and lack of~     standardization during the kidney transplant, there is an indication for performing a~     randomized trial.~      We are planning to perform a double-blind randomized controlled trial . In the study,~     mannitol 20% with a dose of 1g / kg / KG will be compared to placebo with NaCl 0.9% in the~     dose of 5 ml / kg / KG. Patients will be randomized to receive either the mannitol or NaCl.~     The follow-up of the study is a week. Data will be collected, compared and published at the~     end of the study. It is planned to include a total of 100 patients in the study.~   "
26864|NCT02705560|"~     Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific~     foods or food groups. Their exploration and use in the field of dietary assessments could~     provide an objective measure of actual intake complementing classical assessment methods~     (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods~     have been covered by validated biomarkers.~      The study is part of the international project The Food Biomarker Alliance (FOODBALL). The~     study described here has been assigned to assess biomarkers of the intake of milk and~     cheese. Up to now, there is an evident lack of data on specific and validated biomarkers of~     milk and cheese (dairy products), which belong to the most relevant public health related~     foods in Europe. This study will further provide novel insights into the influence of~     fermentation of milk-based foods on metabolic effects and postprandial adaptations, which~     has not yet been studied in depth before using cheese as fermented product. Outcomes will~     support and expand earlier findings on correlation between the intake of fermented dairy~     products intake and human health.~   "
26865|NCT02705547|"~     This study is an exploratory open-label clinical trial of Rosuvastatin in patients with~     Friedreich ataxia (FRDA). This is an outpatient trial with the goal of enrolling 10~     evaluable adults with genetically confirmed FRDA who are between the ages of 18-65. Subjects~     will receive 10mg of oral Rosuvastatin daily for three months.~   "
26866|NCT02705534|"~     The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with~     sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75~     kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the~     sustained viral response rate at 12 weeks.~   "
26867|NCT02705521|"~     This randomised prospective controlled trial will investigate patients with impingement~     syndrome who undergo arthroscopic subacromial decompression. The intervention group will~     receive physiotherapy aided by automated sensor-based technology which will help them~     perform exergames and track their rehabilitation progress. The control group will be treated~     by standard physiotherapy protocols. The two groups will be compared using patient reported~     outcome measures and assessment of shoulder range of movement before and after the shoulder~     surgery.~      Data will be collected on patient experience, engagement with the rehabilitation process and~     the usability of the sensor-based technology through the use exergames. This will guide~     development of methods to quantify patient activation and engagement.~      Hypothesis:~        1. There will be a significant clinical difference in post-surgical improvement measured~          by patient reported outcomes when physiotherapy is aided by automated sensor-based~          technology to perform Exergames and track progress, compared to standard physiotherapy~          protocols.~        2. There will be a significant difference in post-surgical improvement in range of~          shoulder movement and patient improvement, measured by patient reported out-comes when~          physiotherapy is aided by automated sensor-based technology to perform exergames and~          track progress, compared to standard physiotherapy protocols.~   "
26871|NCT02705469|"~     This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in~     patients with mCRPC.~   "
26872|NCT02705456|"~     This randomized double-blind two arm controlled clinical trials evaluates the hypothesis~     that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a~     caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy~     with fixed appliances which is comparable to the caries preventive effect provided by the~     regular use of a fluoridated tooth paste.~   "
26873|NCT02705443|"~     The purpose of this study is to further clarify existing research on the early~     identification and documentation of suspected deep tissue injury (sDTI). Basic principles of~     physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or~     lack thereof) relative to surrounding tissue that will exhibit characteristic thermal~     signatures (temperature). These signatures will be measured and quantitatively recorded~     using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn~     more about their pathophysiological evolution. Additionally, the LWIT physiological data~     will be cross-compared to the gold standard of visual assessment and other current standards~     of wound evaluation.~   "
26874|NCT02705430|"~     The aim of the present study is: to examine some of the mechanisms by which a change in life~     style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this~     computerized life style regulation reduces the development of diabetic complication in a~     small population based study.~      (The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living~     -www.eco-fusion.com)~   "
26875|NCT02705417|"~     The purpose of our study is to compare physical examination alone to color Doppler~     ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of~     vascular access and long-term patency.~   "
26876|NCT02705404|"~     The investigators are doing this research to see if they can use small tissue samples or~     fluid to develop a test that will determine if the tissue samples are related or not related~     to each other. The test will use the patient's DNA, which is part of their unique genetic~     material that carries the instructions for the body's development and function. Cancer can~     result from changes in a person's genetic material that causes cells to divide in an~     uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and~     doctors know some of the genetic changes that can cause cancer, but they do not know all of~     the genetic changes that can cause cancer.~   "
26877|NCT02705391|"~     We intend to investigate the clinical application of two emerging imaging modalities for~     which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing~     Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study~     will involve multi-disciplinary contributions from nationally recognized sarcoma experts in~     Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and~     Pathology.~      Patients will undergo additional magnetic resonance (MR) imaging at the same time as the~     standard imaging.~      The ability to compare several imaging modalities within a single cohort of patients~     maximizes the potential of the study to impact the future management of sarcoma patients.~     The collaborative nature of this study, with essential contributions from many departments~     will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate~     the advanced imaging experience that is acquired.~   "
26878|NCT02705378|"~     Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid~     induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care~     patients, however, is not known. Therefore, the researchers' goal is to investigate whether~     naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients~     already receiving prophylactic stool softeners and simulant laxatives through a~     double-blind, randomized control trial.~   "
26879|NCT02705365|"~     To develop and implement a patient navigator (PN) program for lung screening and smoking~     cessation in community health center primary care practices. This program will be evaluated~     in a randomized controlled trial of primary care patients who currently smoke.~   "
26880|NCT02705352|"~     Full thickness skin grafts are an essential tool in surgery around the eyelids for~     reconstruction or rehabilitation following injury or surgery. Common conditions where skin~     grafts are needed include cicatricial ectropion, restoration of eyelid function after tumor~     removal, burns to the eyelids, or trauma. Early complications, occurring in the first 2~     weeks after surgery, are rare: wound dehiscence, necrosis, infection, bleeding, partial or~     complete graft failure. However, late postoperative complications generally categorized as~     scarring (including graft hypertrophy and contraction, keloid formation, and hypo/hyper~     pigmentation) can limit the success and acceptability of the procedure by patients. Scars~     form following any insult to the deep dermis as a result of wound healing. Factors such as~     age, skin type, racial pigmentation, genetics, and sex may influence fibroblast~     proliferation as part of the healing response, resulting in a suboptimal result. Graft~     contraction is perhaps the most worrisome result, since it can result in failure of the~     initial surgery and may require additional surgery to correct. Many treatments have been~     used to manage these complications: corticosteroid injection, cryotherapy, pressure therapy,~     radiotherapy, laser therapy, silicone based products, and antimetabolite therapy. One such~     antimetabolite, 5-fluorouracil (5-FU), has been used over the last 15 years as an adjunct or~     primary treatment to modulate wound healing and scar formation. Other studies have~     demonstrated safety for cutaneous and subcutaneous injection in the periocular region.~     However, no controlled studies exist. This prospective, randomized, and double-blinded~     clinical study will evaluate the use and benefit of 5-FU versus saline in patients~     undergoing skin grafting for periocular reconstruction. The decision for the need for skin~     grafting will be at the discretion of the attending surgeon and will be made separate from~     enrollment in the study. Surgery will be performed as indicated. The study medication or~     placebo (normal saline) will be administered 2-3 weeks after surgery and then every 2-3~     weeks afterwards for up to a total of 4 injections. After the injections, regular scheduled~     follow-up will be at 3, 6, and 12 months post-op. Outcomes at each study visit (up to 12~     months post-operatively) include graft size, color, contour, and complications between study~     treatment group and placebo group.~   "
26881|NCT02705339|"~     Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib,~     there is a need to understand the molecular mechanisms that lead to primary and acquired~     resistance to rociletinib. The investigators propose to conduct a clinical trial of~     rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including~     exon 19 deletion or L858R mutation), with or without EGFR T790M mutation. In these patients,~     pre-treatment and post-progression biopsy specimens will be subjected to genomic analysis to~     fully understand the clonal evolution and the molecular mechanisms underpinning treatment~     resistance.~   "
26882|NCT02705326|"~     The purpose of this study is to determine if feedback from a three-dimensional real-time~     visualization of the tongue, a program called Opti-Speech, can be used to improve speech.~   "
26894|NCT02705170|"~     To establish if, in patients with new diagnosis of left ventricular dilatation without~     documentation at the coronary artery angiography of significant coronary artery lesions,~     there is a damage of the coronary microcirculation at the IMR (index of microcirculatory~     resistance) assessment~   "
26883|NCT02705313|"~     Advanced Accelerator Applications is currently pursuing marketing approval for~     177Lu-DOTA0-Tyr3-Octreotate (Lutathera). Considering that Phase III NETTER-1 clinical trial~     recruitment has been completed, this expanded access therapeutic protocol aims to allow~     patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors,~     progressive under somatostatin analogue therapy to access the investigational product,~     177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.~   "
26884|NCT02705300|"~     Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it~     has serious side effects, which may require hospitalization.~      The purpose of this study is to investigate whether the addition of tocotrienol can reduce~     the side effects to FOLFOXIRI otherwise leading to hospitalization.~   "
26885|NCT02705287|"~     The goal of this pilot project is to trace the metabolism of vitamin D in the body in~     pregnant and non-pregnant women. At the conclusion of this study the investigators will have~     obtained novel information on the absorption and utilization of vitamin D in women and will~     have validated a new approach. The long-term goal is to better understand the unique~     metabolism of vitamin D during pregnancy.~   "
26886|NCT02705274|"~     Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial~     growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are~     non-inferior to those in eyes that receive standard prompt PRP therapy, however with some~     visual functional benefits and less complications with Ranibizumab arm.~      Applying Protocol S in real world scenario may add cost burden to the patient as patients~     need about 7 injections per year which will cost the patient about 7000 US dollars a year as~     minimum The primary objective of this protocol is to determine the visual acuity outcomes at~     1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg~     instead of Ranbizumab to lower the cost burden~   "
26887|NCT02705261|"~     The study is an open trial to evaluate a web-based intervention. The intervention focuses on~     supporting parents to help their children to overcome problems with anxiety. The children~     who are the focus of the study are in the age ranges of 4 - 12 and experience problems with~     separation anxiety, social anxiety, or generalized anxiety as identified by their parents.~     The program will exclude obsessive-compulsive disorder and post-traumatic stress disorder~     that are seen less often in this age group and require somewhat different interventions.~   "
26888|NCT02705248|"~     The objective of this study is to study the association between insulin resistance and~     recurrent spontaneous miscarriage (RSM).~   "
26889|NCT02705235|"~     Stress is an important determinant of pregnancy health behaviors, maternal physiology and~     maternal-infant health outcomes. The purpose of this study is to explain the relationship~     between dimensions of lifetime stress and the stress hormone cortisol in pregnant women.~     Additionally, the study will examine how coping styles help pregnant women to better manage~     stress and improve their health behaviors to achieve the goal of having a healthy baby.~   "
26890|NCT02705222|"~     The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining~     an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of~     treatment-specific to the cause.~   "
26891|NCT02705209|"~     The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since~     1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal~     cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as~     natural medications to treat painful or aching areas in the case of acute or chronic back~     pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC)~     application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly~     used to treat musculoskeletal conditions of pain especially of the low back.~      Therefore, the aim of the present study was to test effects of a series of ten applications~     of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature,~     skin sensory functions, pain threshold, and proprioception. Placebo control condition (0%~     cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application~     of a CPC will have significant effects on the measured parameters.~      40 subjects will be randomized into Treatment/control group.~   "
26892|NCT02705196|"~     The purpose of this study is to see if LOAd703 (an oncolytic adenovirus) can be safely given~     to patients with pancreatic cancer. The study will also evaluate whether or not intratumoral~     injection of LOAd703 will support current standard of care treatment to reduce the size of~     the tumor and improve survival of the patients.~      Adenoviruses are known as the common cold virus and most individuals have had multiple~     infections during their lifetime. Oncolytic adenoviruses are adenoviruses that are modified~     so they cannot multiply and spread (known as replicating) properly in normal (e.g. healthy)~     cells, but instead, they infect and replicate very well in cancer cells. This strong~     replication leads to the death of the cancer cell. Oncolytic viruses have been evaluated in~     multiple clinical trials for cancer treatment during the past decade and been proven safe.~     It is common to have a fever the first day or two after virus injection since the immune~     system will react to the virus infection. The immune system can also kill cancer cells but~     to do so it needs to be properly stimulated. Oncolytic viruses alone do not seem to be~     strong enough to activate clinically relevant anti-cancer responses. However, it is thought~     that if additional immune system stimulators are added to the oncolytic viruses they may be~     able to result in clinical relevant antic-cancer responses.~      LOAd703 is an oncolytic adenovirus that has been modified to include additional immune~     system stimulators. Specifically, genes that stimulate the immune system have been added to~     the oncolytic adenovirus. Once the oncolytic adenovirus infects the cancer cells, the genes~     will be expressed, resulting in activation of the immune response so it can attack and kill~     cancer cells.~      In this study, LOAd703 will be given by intratumoral injections. It will be given in~     addition to standard of care treatment with gemcitabine and nab-paclitaxel. Because LOAd703~     is an experimental therapy, there will be extra visits for disease monitoring and samples~     accordingly to the detailed information below. The LOAd703 is an investigational agent not~     approved by the FDA.~   "
26893|NCT02705183|"~     Rationale: Bone metastases arise in 50% of all patients dying of cancer, increasing up to~     70% in patients with breast and prostate cancer. The lesions can cause pain and fractures,~     leading to diminished quality of life and poorer survival. Current knowledge concerning~     adequate, personalized treatment of metastatic lesions of the long bones in patients with~     disseminated cancer is insufficient and inconclusive due to lack of large, prospective~     series with patient reported outcome measures. One of the debatable issues is the~     effectiveness of postoperative radiotherapy. It has become common practise due to~     professional opinion, but research evidence is lacking. It is thought that adjuvant~     radiotherapy improves the durability of an implant, prevents progression of the lesion,~     promotes bone healing, improves limb function, minimises pain and reduces the need for~     reoperations, however none of these are certain. Moreover, it is a burden on patient's~     quality of life (e.g. multiple extra hospital visits) causing toxicity and possible side~     effects (e.g. skin irritation). The true beneficial effect, weighing up the possible pros~     and certain cons, of adjuvant radiotherapy is thus unknown.~      Objective: The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared~     to surgery with adjuvant radiotherapy as treatment of impending and actual pathological~     fractures on the pain experienced by patients.~      Study design: A multicentre, prospective, randomised non-inferiority trial nested within the~     OPTIMAL study.~      Study population: All patients with metastases of the long bones undergoing surgery for a(n)~     (impending) pathologic fracture in the participating centres.~      Study intervention: One study arm (A) will receive surgery with adjuvant radiotherapy; the~     other study arm (B) will receive surgery only.~      Main study parameters/endpoints: Primary endpoint is patient reported pain according to a~     numeric rating scale (NRS). Clinical functioning, radiological status, complications and~     survival are secondary endpoints.~   "
26895|NCT02705157|"~     Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up~     to 70% in patients with breast and prostate cancer. The lesions can cause pain and~     fractures, leading to diminished quality of life and poorer survival. Current knowledge~     concerning adequate, personalized treatment of metastatic lesions of the long bones in~     patients with disseminated cancer is insufficient and inconclusive due to lack of large,~     prospective series with patient reported outcome measures.~      Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of~     patients after local treatment (radiotherapy and/or surgery) of metastases of the long~     bones, for both the entire cohort as well as for specific treatments separately. With this a~     more personalized treatment for metastases in the long bones based on expected survival and~     impending fracture risk can be provided in order to improve functioning and the quality of~     life for the remaining lifetime in patients with disseminated cancer.~      Study design: Observational, prospective, multicentre cohort study.~      Study population: All patients with metastases of the long bones visiting a radiation~     oncologist or orthopaedic surgeon.~      Main study parameters/endpoints: Primary endpoints are patient reported quality of life~     (including functioning) and pain levels. Complications and survival are secondary endpoints.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their~     participation. Participation will contribute to deriving patient-specific treatment~     modalities for future patients with bone metastases of the long bones. Risks associated with~     participation in the prospective cohort are considered negligible due to the observational~     nature of the study. The burden for the patients lies in completion of questionnaires, which~     is considered to be in proportion with the potential value of this research.~   "
26896|NCT02705144|"~     To characterize stem cell compartments in their niches in different clinical situations~     (non-diseased compared to emphysematous and fibrotic pulmonary tissue) and to assess their~     proliferative and developmental properties in vitro.~      To further implement lung organoid culture system in the drug screening and development of~     patient personalized medicine.~   "
26897|NCT02705131|"~     The purpose of this study is to evaluate the therapeutic effect and safety of the Balance~     Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the~     mechanism of which this efficacy is achieved.~   "
26898|NCT02705118|"~     Fusion imaging of US and MRI is very helpful for interventional procedure such as~     radiofrequency ablation in liver. However, manual registration of US and magnetic resonance~     (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians.~     Recently, automatic registration function was developed to help the fusion of US and CT/MRI~     imaging. The purpose of this trial is to compare the registration time and accuracy of~     manual registration system and automatic registration system.~   "
26899|NCT02705105|"~     The purpose of this study is to characterize the safety and tolerability and determine the~     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of~     mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.~   "
26900|NCT02705092|"~     The purpose of the study was to examine the immediate effect of subliminal priming with~     subliminal reward stimuli on standing balance in healthy young adults. The study also~     compared the outcomes with the immediate effects of subliminal priming with supraliminal~     reward stimuli.~   "
26901|NCT02705079|"~     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for~     patients. Pain and vasovagal reactions are common. Therefore, the implementation is~     generally recommended under sedation and also carried out in practice here.~      The vital signs monitoring to avoid complications is dictated by current national~     guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure~     measurements. In patients with severe heart disease an ECG recording should be used~     additionally. Moreover, the guidelines require that the sedation is clinically monitored~     continuously to avoid an unwanted anesthetic stage.~      Such evaluation, however, is often difficult under clinical conditions and even~     counterproductive, since a constant response and tactile stimulation of the patient (to~     check clinically the depth level of sedation ), interrupts endoscopic complex intervention.~     However, clinical most relevant aspect is the avoidance of unrecognized transition of~     patients from the stage of deep sedation in an anesthetic stage.~      Current recommendations do not take into account new study results from a gender~     perspective, which showed that women and men need a different wake-up time using the EEG~     derivation means by using teh Narcotrend after total intravenous anesthesia, which may be~     due to different total doses of sedatives needed. However, the research group has been~     demonstrated in a previous study that most likely caused by the use of EEG monitoring~     (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time~     by a lower dose of the administered sedative for a continuous sedation stage D0-D2~     endoscopic retrograde cholangiopancreatography-(ERCP).~      In the presented study the investigators evaluate the extent of gender differences in the~     wake-up time after sedation with propofol during endoscopic ultrasound when using EEG~     monitoring.~   "
26902|NCT02705066|"~     The goal of this project is to determine the effects of 6-week dietary supplementation with~     one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical~     membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy~     middle-aged adults.~   "
26903|NCT02705053|"~     This clinical trial is a study to assess the performance of an automated glucose control~     system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.~     Specifically, the investigators will test zone model predictive control AP that will be~     enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios~     (CR).~   "
26904|NCT02705040|"~     This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.~   "
26905|NCT02705027|"~     A direct application of jejunal tube feeding is necessary especially in patients with~     gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease.~     Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of~     probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are~     beneficial.~      While in a randomized trial of Schwab et al. it could be shown that the use of~     Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly~     faster there are currently no comparative data to use the Easy-In® probe subsequently~     developed , which is directly introduced through the working channel of the endoscope, and~     thus shortening the procedure time.~   "
26906|NCT02705014|"~     To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis~     in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.~   "
26907|NCT02705001|"~     This research project is relevant to the identification of the relationship, and its~     significance, between patient morality and a number of demographic, clinical and corporate~     characteristics. Two separate data sets have been compiled linking the existing intervention~     and employment data, one focusing on the admitting nurse and another one considering all the~     nurses involved in each intervention. Several statistical experiments will take place to~     support or reject the main hypothesis: higher nurse education, satisfaction and staffing~     levels result to lower patient mortality.~   "
26970|NCT02704247|"~     The aim of this porject is to test the Cardiospace system that integrates several medical~     devices to monitor the cardiovascular system:~        -  ECG~        -  Brachial blood pressure~        -  Continuous finger blood pressure~        -  Ultrasound~        -  Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the~          cardiovascular system of astronauts for research purpuse.~   "
26908|NCT02704988|"~     Regional lymph node metastasis is a major determinant of local recurrence and overall~     survival rates in patients with colorectal cancer. Because of the poor prognosis associated~     with the presence of lymph node metastasis, stage III colorectal cancer patients should~     receive adjuvant treatment with chemo and / or radiation therapy according to the site of~     tumor. Several authors have investigated the use of revealing solutions for lymph node~     clearance in colorectal cancer. Most studies comparing conventional histopathological~     specimen examination to any lymph node clearing technique showed that the use of revealing~     solutions increases the mean number of lymph nodes harvested, usually in a statistically~     significant manner. It is still controversial the impact of the use of revealing solutions~     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.~     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF~     and Carnoy solutions for the histopathological examination of patients with colorectal~     cancer. The aim of this study is to determine the lymph node revealing solution with the~     best performance (increase in the mean number of lymph node harvested and lymph node~     upstaging) in patients with colorectal cancer.~   "
26909|NCT02704975|"~     The purpose of this single-blinded, randomized clinical trial is to determine the~     effectiveness of dry needling compared to a standard shoulder rehabilitation program on~     range of motion, functional movement, and pain in patients who have undergone shoulder~     stabilization surgery. Measurements of the aforementioned dependent variables will be taken~     at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It~     is hypothesized that the inclusion of dry needling will result in an increase in range of~     motion, increase in functional movement, and decrease in pain at an accelerated rate when~     compared to rehabilitation alone.~   "
26910|NCT02704962|"~     The investigators hypothesis is that an antipsychotic drug combination of low-dose~     olanzapine plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy~     in efficacy and safety for treatment of schizophrenia.The goal of this study is to compare~     the efficacy and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus~     trifluoperazine (5 mg/d) in the treatment of acute psychotic exacerbations of schizophrenia.~   "
26911|NCT02704949|"~     One of the most effective strategies to decrease radiation exposure during ureteroscopy is~     to use low dose. However, the quality of the image obtained is inferior to full dose image.~     The main concern is to maintain the stone free and complication rate despite the inferior~     quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼~     instead of full dose would impact in a reduction of total radiation exposure despite a~     possible increase in fluoroscopy time. Also, if this strategy would impact in operation~     time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for~     ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18~     years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were~     counseled regarding their treatment options. Patients who failed spontaneous passage or~     medical treatment or chose endourologic treatment were included in this study. Patients with~     abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were~     excluded from the study.~   "
26912|NCT02704936|"~     Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm~     and seminal plasma linking the success or failure of the artificial insemination (IUI)~   "
26913|NCT02704923|"~     A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for~     preventing Ventilator-Associated Pneumonia.~   "
26914|NCT02704910|"~     The objective of this study is to assess the origins of lateral postural inclination~     presented by some Parkinson disease's patients.~      Several mechanisms could cause lateral postural inclination. Available data allow to suggest~     three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of~     perception of corporal axis~   "
26915|NCT02704897|"~     This study aims to evaluate if a smartphone-delivered tool can help assess for wound~     infections, and if this improves access to care and results in earlier treatment.~     Participants will be randomised to one of two groups. The intervention group will receive~     the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about~     their wound. The trial period is 30 days.~   "
26916|NCT02704884|"~     The aim of the present study was to determine the effects of fortified soy milk with L.~     planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II~     diabetic patients with nephropathy.~   "
26917|NCT02704871|"~     A non-interventional, prospective observational study to assess the performance of~     SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and~     surgical wards with infection-positive from infection-negative SIRS~   "
26918|NCT02704858|"~     NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients~     with recurrent glioblastoma. NEO100 is delivered four times a day by intranasal~     administration using a nebulizer and nasal mask for up to 6 months. Four escalating doses~     will be evaluated for tolerability, and the maximum tolerated dose will be extended in the~     2A phase for a total of 25 patients. There is no concurrent control. This is the first nasal~     administration in the US, after prior oral studies with perillyl alcohol proved ineffective.~     Nasal administration of perillyl alcohol is on-going in Brazil~   "
26919|NCT02704845|"~     The biopsychosocial model is well established in chronic low back pain (CLBP) research.~     Nevertheless, researchers to date have overlooked the biopsychosocial aspects of~     Inflammatory Low Back pain (ILBP). Most health care providers are biologically oriented in~     their treatment of ILBP, neglecting its possible multidimensional nature. It is true that~     people with ILBP may present with more complex pain and physical limitations than those with~     chronic non-specific low back pain (CNSLBP), but it remains unexplored whether or not these~     limitations are affected by the same pain factors that affect CNSLBP patients. This study~     aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and~     CNSLBP.~   "
26920|NCT02704832|"~     Randomized trials have already demonstrated that geriatric intervention was able to improve~     survival in the general elderly population but only a few have been performed in cancer~     patients. At the end, these data are not sufficient to consider geriatric intervention as~     validated in this setting. Case Management, coordinated by a geriatrician and a trained~     nurse, could improve prognosis of elderly patients with cancer. This approach, can be~     integrated in daily oncology practice. This strategy will be compared to usual oncological~     management in a randomized phase III trial.~   "
26921|NCT02704819|"~     Balance is crucial for an individual's mobility and independence. Human balance is achieved~     and maintained by a complex set of sensorimotor systems that include sensory input from~     vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation).~     This information is then integrated by the brain. This complexity leads to undiagnosed or~     mistreated patients with balance disorders for long period which can affect their daily~     activities.~      The EMBalance project is a research project funded by the European Union, involving 10~     universities across Europe. Its aim is to create a Decision Support System (DSS) to support~     doctors in diagnosing and treating balance disorders. It will be available to primary and~     secondary care doctors of different specialties, levels of training and in different parts~     of the country.~      The DSS will:~        -  Be used by primary and secondary health care professionals~        -  Assist the doctor on the evaluation and management of dizzy patients~        -  Predict how the balance disorder may progress~        -  Reduce patient waiting time and the onward referrals~        -  Ensure patients receive prompt and efficient treatment plans~      The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre,~     single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United~     Kingdom. At present, the question that this study aims to answer is whether the algorithms~     developed for the EMBalance Platform will yield meaningful information and how these~     algorithms and platform can be improved, performing an offline comparison of the classical~     diagnostic approach and the outcome of the EMBalance platform, without any consequence for~     the patient.~      Patients who present with balance related symptoms at primary care will be randomised to~     either intervention group (non-specialist doctor +DSS) or control group (non-specialist~     doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions~     made by the non-specialist doctors in order to determine whether the use of the DSS can help~     them in a more precise assessment.~   "
26922|NCT02704130|"~     This single-center, prospective randomized controlled trial (RCT) is designed to compare the~     outcomes and clinicopathologic results of transarterial chemoembolization (TACE) and~     microwave ablation (MWA) combination therapy with MWA monotherapy for the treatment of early~     (stages 0 and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test~     the following hypothesis: 2-year intrahepatic disease-free survival does not differ between~     patients receiving the experimental therapy (MWA + TACE) and patients receiving the standard~     therapy (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine~     the clinical feasibility of TACE + MWA in HCC patients with a small tumor burden using~     patient demographics and disease characteristic data and 2) to determine the effect of TACE~     on radiographic tumor characteristics in this patient cohort.~   "
26923|NCT02704117|"~     The purpose of this study is to test the effects of non-invasive neuromodulation,~     transcranial direct current stimulation (tDCS), on brain function in individuals with~     obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which~     brain stimulation might change the functioning of regions implicated in OCD, and thereby~     inform possible future therapeutic uses.~   "
26924|NCT02704104|"~     This study is designed to monitor patient safety after excision of skin lesions and~     subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5~     for controlling bleeding in skin wounds.~   "
26925|NCT02704091|"~     The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo~     regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in~     adult subjects.~   "
26926|NCT02704078|"~     Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly~     established modality for diagnostic evaluation of mediastinal lesions. The procedure is~     routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New~     Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions~     using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal~     Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely~     performed in the department) and has been described as a safe and efficacious modality.~     EUS-B-FNA is usually employed when EBUS-TBNA is not feasible or excessive cough or~     secretions necessitate switch to esophageal route. We hypothesize that EUS-B-FNA as the~     primary approach has similar diagnostic performance as EBUS-TBNA and is associated with~     greater patient and operator rated procedure comfort and lesser requirement of anaesthesia~     medications for evaluation of patients with mediastinal lesions easily accessible with~     either of the two approaches.~      We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA)~     versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS~     scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total~     of 100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal~     lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and~     preliminary investigations, patients shall be randomized equally into the two approaches.~     Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation~     (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be~     comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary~     objectives will include operator rated cough (VAS), Overall operator rated procedure comfort~     (VAS), dose of midazolam and fentanyl administered and total procedure duration.The primary~     data analysis shall be for the performance characteristics of the primary approach. All the~     aspirates shall be analysed by the same pathologist for final interpretation.~   "
26927|NCT02704806|"~     Researchers use FCM to analyze the immunol cell feature and its corresponding activation~     status, as well as the thromb aspirated through the thromb aspiration device in AMI patients~   "
26928|NCT02704793|"~     Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition~     which is known to be the second most common movement disorder of the adult population only~     after restless legs syndrome. The prevalence of the disorder in all age groups has been~     estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe~     technique which has been used in diagnosis and treatment of many neurologic and psychiatric~     conditions. Recent studies have shown that cerebellum has a significant role in development~     of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study~     researchers will recruit at least 30 subjects among patients visiting at the Specialty~     Clinic of Mashhad Medical University according to researchers exclusion and inclusion~     criteria and after signing a written informed consent, will randomly be assigned to either~     real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz~     rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5~     consecutive days and sham treatment will be performed with the same protocol using a small~     device placed on the TMS coil (not visible to the patients) producing electrical stimulation~     (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be~     protected with earplugs during both real and sham stimulations. After 2 months of follow-up,~     patients will undergo crossover and receive the other treatment as described above. Patients~     would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and~     30 after each real or sham treatment session by a blinded researcher. Data will be analysed~     by another researcher who is also blind.~   "
26929|NCT02704780|"~     This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for~     the treatment of retained placenta to reduce the need of manual removal of placenta under~     general anaesthesia~   "
26930|NCT02704767|"~     Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant~     EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add~     apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.~   "
26931|NCT02704754|"~     Problems sleeping are common after exposure to highly threatening experiences and can occur~     with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments~     for PTSD are limited for addressing insomnia and many insomnia treatments appear to be~     limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved~     drugs has a unique mechanism of action that may be well suited for targetting arousal at~     night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for~     insomnia that developed in relation to trauma exposure, utilizing a placebo control, and~     polysomnography to identify biomarkers of response, in a six week trial.~   "
26932|NCT02704741|"~     The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321~     for dermatologic procedures requiring ablation and coagulation of soft tissues, including~     the skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina~     (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol.~      Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment~     visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks).~      Methodology described in protocol to evaluate efficacy of treatments will be carried out at~     each visit at the clinic.~   "
26933|NCT02704728|"~     The purpose of this study is to assess the safety and tolerability of Bacteroides~     thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable~     Crohn's disease.~   "
26934|NCT02704715|"~     The purpose of this study is to evaluate the postoperative pain after general anesthesia of~     orbital diseases and ocular tumor patients.~   "
26935|NCT02704702|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and~     rosuvastatin when coadministered or administered alone as a single dose or as multiple doses~     to healthy male subjects.~   "
26936|NCT02704689|"~     This is a post-market clinical study of the AccuLIF expandable TLIF cage in patients~     requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis~     or retrolisthesis, at one or two levels, between L2 and S1.~   "
26937|NCT02704676|"~     The Aim of this study is to determine the relationship between serum concentrations of~     cancer antigen-125 (CA-125) and pre-eclampsia severity.~   "
26938|NCT02704663|"~     In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups:~     transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and~     patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and~     costs.~   "
26939|NCT02704650|"~     The purpose of this study is to:~        1. Identification and characterization of ovarian carcinoma well-known biomarkers,~          carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential~          biomarkers in vaginal fluids obtained from ovarian cancer patients.~        2. Quantification and calibration of identified biomarkers in vaginal discharge collected~          from ovarian cancer patients in comparisons to samples collected from healthy~          volunteers.~        3. Comparison analysis of biomarkers levels in vaginal fluids vs. serum.~        4. Quantification and calibration of identified biomarkers in vaginal discharge collected~          from ovarian cancer patients diagnosed in various stages.~   "
26940|NCT02704637|"~     HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely~     and accurately monitor physiological signs of the brain with minimal discomfort to patients,~     providing information about normal or abnormal brain-related conditions and providing~     decision-making support for physicians. The investigators hypothesize that the HS-1000 is~     capable of detecting vasospasm using the raw acoustic data derived from the noninvasive~     procedure.~   "
26941|NCT02704624|"~     Thus, the aim of the current study is to assess the influence of vitamin D deficiency and,~     consequently, of serum calcium deficiency in the body composition, muscular activity, bone~     mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to~     determine the impact of vitamin D supplementation on this population.~   "
26942|NCT02704611|"~     The aim of this study is to assess the effectiveness of transcranial direct current~     stimulation (tDCS) in treating fibromyalgia.~      Participants will be randomly assigned to one of the two groups: Group I (Intervention~     group) tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode~     centered over M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s~     ramp out) will be applied daily for 10 consecutive days (5 sessions/week) . The anodal~     electrode (24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left~     primary motor area in group I, and the reference electrode (24 cm² will be fixed over the~     contralateral arm (extracephalic).~      Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II~     will receive sham tDCS will be applied using the above described parameters in group I. For~     sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical~     to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However,~     since none of the patients have been experienced tDCS previously, they were unaware of which~     stimulation is real and which sham is. The investigator responsible for delivering tDCS had~     no contact with the patients. All study participants will be followed up by the same~     evaluation sheet and by an evaluator who are blinded to the type of intervention she /he has~     received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one~     month and post 2 months by using wide spread pain index (WPI) & symptoms severity of~     fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed~     using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using~     Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start~     sessions and after end 10 sessions.~   "
26943|NCT02704598|"~     This is a prospective, randomized study, aiming to evaluate patients with Deep Venous~     Thrombosis in lower limbs and the recanalization rates evaluated with DUPLEX ultrasound, as~     so the clinical outcomes in patients submitted to oral anticoagulation with Rivaroxaban~     versus Warfarin.~   "
26944|NCT02704585|"~     Time to stable reading of oxygen saturation at the delivery room will be compared between~     two different devices.~   "
26945|NCT02704572|"~     The purpose of this study is to determine the optimal timing of zoster vaccination to induce~     both higher cell-mediated immunity and humoral immunity in adult patients aged over 50 with~     history of zoster within 5 years.~   "
26946|NCT02704559|"~     A randomized, open-label, oral dose, crossover study to explore drug-drug interactions~     between DWC20155 and DWC20156 in healthy subjects.~   "
26947|NCT02704546|"~     The purpose of this study is to explore the possible effects of MPH use on physiological~     functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic~     and anaerobic capacity, to characterize the tendency for muscle break down while performing~     monitored moderate physical effort and to assess the physiological strain while performing~     moderate exercise in heat load conditions by using the heat tolerance test.~   "
26948|NCT02704533|"~     MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization~     with PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5,~     1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total dose between 2.7x10^6 and 8.1x10^6 PfSPZ~     followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge).~      PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of~     ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.~   "
26949|NCT02704520|"~     This trial evaluates a novel imaging method called magnetic resonance tumour regression~     grade (mrTRG) to assess how well a tumour has responded to chemoradiotherapy in patients~     with rectal cancer. The TRIGGER Trial aims to evaluate mrTRG as a tool for stratifying the~     management of patients according to their response to treatment.~   "
26950|NCT02704507|"~     A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial~     comparing topical retinoid on half the face and retinoid plus topical steroid on the other~     half.~   "
26951|NCT02704494|"~     The aim of this study is to evaluate the safety and effects of resveratrol in treatment of~     diabetic nephropathy.~   "
26952|NCT02704481|"~     The primary outcome of this study is to compare the effectiveness of a second complete~     course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following~     mifepristone-misoprostol medical abortion.~   "
26953|NCT02704468|"~     Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event~     after renal transplantation. And remain a major cause of mortality. The major risk marker is~     arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall~     stiffness and can estimated the risk of atherosclerosis.~      Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in~     cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid~     artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to~     study the association between CAVI and FGF-21 and their relations to various parameters that~     can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other~     traditional basic factors.~   "
26954|NCT02704455|"~     This study is a multicenter, prospective cohort study of patients diagnosed with primary~     ciliary dyskinesia, the clinical information of recruited patients, including clinical~     manifestations, lung function, chest imaging, quality of life and other indicators, will be~     followed for 10 years.~   "
26955|NCT02704442|"~     The hypothesis is that pediatric patients with increased levels of anxiety on the day of~     surgery, in particular at point of anesthetic induction, will demonstrate decreased~     compliance with assessment in ophthalmology clinic postoperatively.~   "
26956|NCT02704429|"~     Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus~     vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy,~     and with conventional immunosuppressive rescue treatment, if indicated. The duration of~     therapy will be 12 weeks, followed by 12 weeks of follow up.~   "
26957|NCT02704416|"~     This trial aims to develop evidence based curative treatment with optimal net benefit for~     patients with Brugada syndrome.~   "
26958|NCT02704403|"~     The primary objectives of this study are to evaluate the effect of Elafibranor treatment~     compared to placebo on 1) histological improvement and 2) all-cause mortality and~     liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.~   "
26959|NCT02704390|"~     The purpose of this study is to evaluate the long-term safety and efficacy of~     ORADUR®-Methylphenidate in children and adolescents with ADHD.~   "
26960|NCT02704377|"~     This pilot clinical trial studies quality of life and supportive care preferences following~     radiation therapy in prostate cancer survivors. Studying quality of life and supportive care~     preferences in patients undergoing radiation therapy may help identify the effects of~     treatment on patients with prostate cancer.~   "
26961|NCT02704364|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282~     in patients with Primary Sclerosing Cholangitis.~   "
26962|NCT02704351|"~     The purpose of this study is to retrospectively review our preliminary experience during a~     surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade~     following CPB and cardiac surgery for repair of CHD in infants and children.~   "
26963|NCT02704338|"~     Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune~     hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.~   "
26964|NCT02704325|"~     The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy~     (DMD) patients that will involve direct intramuscular injection to the extensor digitorum~     brevis muscle (EDB).~   "
26965|NCT02704312|"~     Compare dosimeters in both positions (prone and decubitus) for each patient~   "
26966|NCT02704299|"~     Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with~     Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.~   "
26967|NCT02704286|"~     The investigators have created an interactive knee osteoarthritis (OA) risk calculator that~     estimates a user's risk of developing symptomatic knee OA as well as the user's risk for~     undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the~     calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk.~     Participants were randomized to either access general information about OA or use the risk~     calculator in addition to accessing general OA information. The investigators hypothesized~     that participants randomized to the risk calculator arm would have more accurate perception~     of their knee OA risk and would have increased willingness to change risky behavior compared~     to the general OA information group.~   "
26968|NCT02704273|"~     This is a pre-Phase 1 prospective, non interventional clinical assessment study to evaluate~     XLMTM subjects aged 3 years and younger. Many of these clinically relevant measures have not~     yet been routinely assessed in this population and may provide important insight on the~     natural history of XLMTM and for future evaluation of potential therapies.~   "
26969|NCT02704260|"~     search for a genetic cause of vascular endofibrose~   "
27014|NCT02703610|"~     The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of~     the comparative efficacy of 4 oral analgesics in the the management of acute musculoskeletal~     extremity pain in elderly patients who present and then are discharged from the ED.~   "
26971|NCT02704234|"~     Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their~     genitals between the vagina and labia (lips of the vagina). They also have pain when they~     have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain,~     that they cannot have sex.~      This research is being done for two reasons. The first reason is to test a set of special~     needles called double-blinded acupuncture needles to give acupuncture treatments (one is a~     real needle and the other is a fake needle). The second reason is to develop a protocol~     (checklist) that will be used in this and future studies, and to identify and resolve any~     procedural problems. The protocol will be first tested by the principal investigator who is~     also an acupuncturist. The investigator will perform acupuncture using the protocol, if~     necessary change the protocol, and then teach a second acupuncturist using the modified~     protocol how to use the double-blinded acupuncture needles.~      The real needle called the penetrating needle penetrates the skin. The fake needle called~     the non-penetrating placebo touch needle does not penetrate the skin but it touches the skin~     so it feels like a needle is being inserted. It has a blunt tip.~      Participants can't see which needle they are getting acupuncture with because the needles~     are housed in a double-blinded needle device which has two tubes (an inner and an outer)~     that neither the acupuncturists nor the participants can see through.~      If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used~     for drug studies to see how well the real medicine works, the investigators can see how~     effective acupuncture is. The investigators will be testing these needles to treat~     participants with vulvodynia.~   "
26972|NCT02704221|"~     This study is a feasibility trial, testing the hypothesis that among sedentary mothers of~     behaviorally at-risk preschool-aged children, those who receive behavioral parent training~     (BPT) programs and concurrently increase their physical activity levels will demonstrate~     improved parenting and child behavior outcomes compared to those who receive BPT but remain~     sedentary.~   "
26973|NCT02704208|"~     The Thrive With Me (TWM) trial is testing the efficacy of a mobile enhanced website aimed~     at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with~     men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with~     social networking and gaming components. In addition to real-time peer-to-peer support~     capabilities, the TWM intervention provides participants with Antiretroviral Therapy (ART)~     adherence self-monitoring tools, medication dose reminders, and HIV-related informational~     content.~   "
26974|NCT02704195|"~     Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on~     freezing of gait in Parkinson's disease~   "
26975|NCT02704182|"~     The objective of this study is to detect the effect of trans-cranial direct current~     stimulation on postoperative pain and opioid consumption in total knee arthro-plasty~     patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4~     sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given~     on 4 consecutive postoperative days, group 1 will receive real stimulation with the active~     electrode over the leg representation of the motor strip (cortical motor area of the leg)~     and the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be~     evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line)~     after 1st, 2nd, 3rd and 4th sessions.~   "
26976|NCT02704169|"~     The last decade has seen progressive advances in RT delivery, such as intensity modulated~     radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly~     precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more~     selective treatment of the primary tumour and surrounding neck nodes by reducing the dose~     inflicted on critical organs at risk without compromising tumour dose and. IMRT has been~     shown to significantly decrease radiation-induced toxicity, and is now considered standard~     treatment for H&N tumors. With these advances in delivery technology, the accurate~     definition of the target is emerging as the weakest link in the radiotherapeutic treatment~     chain. Accurate target definition is the primary link on which all subsequent treatment~     planning and delivery depend and is therefore critical for successful RT. Incorrect target~     definition can result in poorer outcomes through either less tumour control, more normal~     tissue toxicity, or both. Computed x-ray tomography (CT) is the standard volumetric imaging~     modality for RT because of its high resolution, accurate definition of anatomy and its~     intrinsic measure of electron density necessary for accurate dose calculation. However, its~     ability to distinguish between tumour and normal tissue is limited due to a lack of contrast~     for structures of similar electron density and image artifacts for objects of high density.~     This additional noise can result in large inter-observation variability. Disease visible on~     endoscopy can be contoured and registered to the planning CT, allowing inclusion of~     superficial disease invisible on the volumetric CT image dataset into the treatment plan.~   "
26977|NCT02704156|"~     The safety and efficacy of five-fraction stereotactic body radiation therapy treating~     locally advanced pancreatic cancer~   "
26978|NCT02704143|"~     The safety and efficacy of combination of SBRT with Cyberknife with S-1 in treating~     pancreatic cancer will be evaluated.~   "
26979|NCT02704065|"~     End-stage renal disease related to AA amyloidosis is well characterized but there is limited~     data concerning patient and graft outcomes after renal transplantation. The aim of this~     study is to evaluate the clinical features of, and risk factors for recurrent AA~     amyloidosis, as well as the effects of these factors on the ultimate outcome of renal~     allografts.~   "
27000|NCT02703792|"~     This qualitative study uses focus group methodology and purposive sampling with the aim of~     obtaining views of Care Home Support Service staff and other stakeholders about their~     experiences of a redesigned National Health Service (NHS) Care Home Support Service.~     Individual stakeholder focus groups will be conducted with General Practitioners (GP), care~     home staff, relatives of residents in care homes, service-user representatives (Total N=32,~     across 4 focus groups). This study forms part of a larger evaluation of the CHSS service;~     service improvement workshops will be conducted with Oxford Health NHS Care Home Support~     Service, Community Nursing and Community Mental Health staff that are working in the 102~     participating homes. Each participant who consents will take part in a focus group to~     explore their experiences of a redesigned NHS care home support service. Participants will~     be involved in the study for up to six months from gaining informed consent until last~     contact with the research team when a summary of the research will be sent. The data will be~     analysed using thematic analysis and applied with the Reach, Effectiveness, Adoption,~     Implementation and Maintenance (RE-AIM) framework.~   "
26980|NCT02704052|"~     Venous thromboembolism (VTE) encompasses deep venous thrombosis and pulmonary embolus, and~     is the proximate cause of death in over 100,000 hospitalized patients per year. To put this~     in better context, VTE kills more people each year than the annual morbidity from motor~     vehicle crashes and breast cancer combined. Surgeons commonly provide enoxaparin, a low~     molecular weight heparin, for VTE prophylaxis. Enoxaparin's activity is quantified by~     anti-Factor Xa (aFXa) levels. Studies of enoxaparin metabolism in patients with traumatic~     injury, thermal injury, or those undergoing reconstructive surgery have shown that standard~     dosing can result in inadequate aFXa levels, likely from the hypermetabolic state associated~     with significant injury. Small studies have associated subtherapeutic aFXa levels with~     increased risk for life or limb-threatening VTE events. Prior work from has shown that 2-10%~     of highest risk surgical patients have a VTE event despite enoxaparin prophylaxis. The~     investigators believe that surgical patients would benefit from an individualized dosing~     regimen for enoxaparin prophylaxis and that individualized dosing will decrease observed~     rates of life or limb-threatening post-operative VTE events.~      This project will critically examine the pharmacokinetics of prophylactic doses of~     enoxaparin in surgical patients, and will evaluate how alteration of enoxaparin dose~     magnitude and frequency affects peak and trough aFXa levels as well as risk for re-operative~     hematoma. If subtherapeutic aFXa levels are observed, the study will design, implement and~     test a clinical protocol to optimize post-operative aFXa levels. Although not an explicit~     Aim, this study will also provide important preliminary data on VTE rates in surgical~     patients with in range and out of range aFXa levels.~   "
26981|NCT02704039|"~     The goal of this research program is to develop a simple, noninvasive diagnostic device for~     assessing skin pathology without the need for a biopsy. The device being studied is a single~     system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and~     laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this~     objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy~     of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250~     patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for~     diagnosing skin malignancy.~   "
26982|NCT02704026|"~     Malnutrition and growth retardation are common in children with inflammatory bowel disease~     (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type,~     anatomical location, severity of disease and age of patient. Recently, it is reported that~     almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass,~     however, body fat alteration are not well defined.~      The aim of this prospective and observational study was to evaluate nutritional and growth~     status and body composition of children with IBD using anthropometric measurement and~     bioelectrical impedance during 1 year follow-up.~   "
26983|NCT02704013|"~     It is a single-center, prospective, interventional, single-arm study. Aim is to investigate~     which variables are significantly correlated with prolonged anticholinergic treatment (>6~     months) in children with overactive bladder (OAB). Investigated variables will include~     urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score~     scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and~     specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics~     and treatment outcome.~   "
26984|NCT02704000|"~     This study evaluates the efficacy and cost-effectiveness of two platforms for delivering~     home visiting programs in the poor urban setting of Sao Paulo's western region: a program~     delivered by a newly trained cadre of Child Development Agents, and a program delivered by~     Community Health Agents employed by the government as part of the Family Health Strategy~     (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that~     is currently being adapted to the local context. The primary outcome of the program will be~     cognitive development for children aged 9 to 15 months old at baseline (21-27 months at~     endline) The secondary outcomes will include child physical development as well as maternal~     mental health.~   "
26985|NCT02703987|"~     The purpose of this study is to investigate the effect of a fermented infant formula on~     lactose digestion in lactose intolerant adults.~   "
26986|NCT02703974|"~     The study will collect and analyze quantitative data regarding handwashing behaviors among~     school-aged children to determine the impact of nudges compared to handwashing and hygiene~     education programs.~      Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates~     of handwashing than traditional handwashing and hygiene education programs.~   "
26987|NCT02703961|"~     The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy.~     The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause~     of failure in local advanced cervical cancer treated with 3-dimensional conformal~     radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study~     is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with~     cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year~     disease free survival would be increased by 10% with this new treatment schedule.~   "
26988|NCT02703948|"~     This is a multi-center, open-label, single-arm study to assess the safety of an injection~     technique with Restylane Silk in lip augmentation and correction of perioral rhytids .~   "
26989|NCT02703935|"~     Background: Cancer-related fatigue is the most common concern reported by Childhood cancer~     survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating~     its impact.~      Purposes: To examine the effectiveness of an adventure-based training programme in promoting~     regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong~     Chinese childhood cancer survivors.~      Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated~     post-test, between subjects design has been conducted. Recruitment of subjects has been~     carried out in an outpatient clinic, and through the Children's Cancer Foundation and~     Sunshine Group, which are non-profit voluntary organizations with the aim to provide~     education and supportive services to parents of Hong Kong Chinese childhood cancer~     survivors.~      Intervention: Participants in the experimental group have joined a four-day adventure-based~     training programme, which contains education talks, a workshop and adventure-based training~     activities. Those in the placebo control group has received an amount of time and attention~     (leisure activities organized by a community centre) that mimick that received by the~     experimental group.~   "
26990|NCT02703922|"~     Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a~     vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The~     diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is~     based on a combination of clinical, biological and histological signs. Temporal artery~     biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks.~     Therefore, researches of the past 20 years have been intended to develop alternative~     diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since~     the description by Wolfgang Schmidt of the halo sign. Although European and British~     recommendations put CDU as second line method, many authors suggest the possibility to do~     without TAB in many cases. In addition, many practitioners believe that it is not ethical~     to use an invasive unprofitable procedure like TAB, and have already been using CDU in their~     routine practice. However, no diagnostic algorithm validating this approach in a prospective~     series has been published to date. Therefore, the present study aim at validating a~     diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal~     arteries and cervicocephalic axes as first screening method.~   "
26991|NCT02703909|"~     Obesity affects more than 78 million adults in the United States and it is estimated that~     35% of the US population is obese. Currently, more than 179,000 bariatric procedures are~     performed in the US each year with the majority of these surgeries using laparoscopic~     techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but~     there is no evidence that a deep NMB improves surgical conditions and that the surgeons can~     discriminate between a moderate and deep NMB. There is also evidence that maintaining low~     insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal~     of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis~     that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in~     the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize~     lower insufflation pressure and decreases postoperative pain requirements after laparoscopic~     bariatric surgery.~   "
26992|NCT02703896|"~     Effect of orally administered two equal and consecutive doses of proton pump inhibitors,~     omeprazole, lansoprazole, esomeprazole , rabeprazole and pantoprazole and Histamine 2~     receptor antagonists cimetidine, ranitidine,famotidine,nizatidine and lafutidine without and~     with a prokinetic agents domperidone, metoclopramide and erythromycin on intragastric pH,~     volume and bile refluxate.~   "
26993|NCT02703883|"~     The purpose of this study was to evaluate the effectiveness of body weight-supported~     treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord~     injury (SCI) in chronic stage~   "
26994|NCT02703870|"~     The purpose of this Study is to determine whether non-invasive transcranial direct current~     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual~     Cortex.~   "
26995|NCT02703857|"~     The surgical site infection is one of the most important causes of postoperative morbidity.~     The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical~     site infections. The recommendations of the French Society of Anesthesia Resuscitation on~     antibiotic prophylaxis in long surgeries are based on low documentation, including frequency~     and dosage of reinjection.~      The main objective of the study is to describe the tissue and plasma pharmacokinetics of~     cefoxitin after repeated injections.~      This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of~     major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic~     prophylaxis by cefoxitin.~      They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then~     every 2 hours until closing.~      The primary endpoints are:~        -  Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after~          start of each infusion cefoxitin~        -  Tissue free concentrations of cefoxitin every 20 minutes after the start of the first~          infusion cefoxitin until skin closure~        -  Urinary concentrations of cefoxitin~   "
26996|NCT02703844|"~     The purpose of this study is to determine whether caloric vestibular stimulation improves~     symptoms of Parkinson's Disease.~   "
26997|NCT02703831|"~     Two recent studies showed that having two attending spine surgeons performing complex adult~     spine deformity surgery instead of one, decreased complications, unplanned surgeries within~     30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein~     thrombosis and post-operative neurologic complications [Sethi]. However, both studies were~     retrospective and did not evaluate any cost-savings associated with having two spine~     surgeons instead of one performing complex spine deformity surgery.~      Most cost-effectiveness studies have used traditional accounting (TA) methods to determine~     costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC)~     [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery.~      Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce~     downstream costs compared to a single spine attending for complex spine surgeries using~     traditional accounting methods; and (2) to demonstrate an application of the TDABC method to~     evaluate the operating room phase during complex adult spinal deformity surgery and compare~     it to traditional accounting methods (TA).~   "
26998|NCT02703818|"~     This is a prospective, multi-center post-market study of the Senza System in subjects with~     chronic, intractable pain of the upper extremities. Data at follow-up visits will be~     compared to Baseline data collected at the beginning of the study.~   "
26999|NCT02703805|"~     Building on an earlier pilot study, this randomized controlled trial will compare the~     effectiveness of a 12 week community YMCA-based wellness program specifically designed for~     people with stroke (Fit for Function) to a standard YMCA membership.~   "
27001|NCT02703779|"~     Explore stem cell collection with or without bortezomib with in-vivo purging in multiple~     myeloma.~   "
27026|NCT02703454|"~     The study is designed as a prospective, multicenter, single-blind, randomized study to~     assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures~     for the treatment of symptomatic PAF. The subjects will be blinded to study treatment for~     the duration of the study period.~   "
27068|NCT02702908|"~     This study aims at estimating the incidence of second primary malignancies as well as the~     overall survival among metastasized prostate cancer (mPC) and metastasized~     castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride.~   "
27002|NCT02703766|"~     This study aims to examine the role of weight gain in adipose tissue immune cell influx and~     development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic~     systemic inflammation is implicated in the development of cardiometabolic disorders in~     obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating~     obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease.~     Proinflammatory cytokines contribute to the initial influx of immune cells into adipose~     tissue during weight gain. However, mechanisms regulating these cytokines in the adipose~     tissue milieu and the effects of weight gain on adipose tissue are not completely~     understood.~      The study proposes to investigate the molecular events contributing to increased~     infiltration of macrophages and T-cells into adipose tissue during weight gain. The central~     hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is~     associated with decreased expression of proinflammatory cytokines. However, in obesity (high~     body fat mass), adipose tissue is altered, which permits increased expression of~     inflammatory cytokines and further fat gain results in influx of immune cells. To test the~     hypothesis, adipose tissue from well characterized lean (control, with low body fat) and~     obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be~     used. Adipose tissue samples after subsequent weight loss will also be examined.~      For this study, obesity will be defined by body composition rather than body mass index~     (BMI), as several studies have shown that BMI does not adequately define obesity and several~     individuals with normal BMI may indeed have high body fat mass. Individuals with body fat~     content ≤25% for men, & <35% for women) will be considered lean and individuals with body~     fat content >25% for men, ≥35% for women will be considered obese.~   "
27003|NCT02703753|"~     This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish~     who have a high risk on perinatal morbidity because of overweight or obesity. Half of the~     patients will receive the lifestyle intervention while the other half will receive usual~     care. It is hypothesized that an effective lifestyle intervention directed towards healthy~     living, including reduction of overweight or obesity and, if applicable, smoking reduction,~     health problems in mothers and their offspring can be prevented.~   "
27004|NCT02703740|"~     This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in~     the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF~     (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).~   "
27005|NCT02703727|"~     Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict~     adherence is needed.Thus, medication review and identification of safety issues and~     knowledge gaps about OAC is critically important. The polymedication check (PMC) is a~     reimbursed intermediate medication review focusing on adherence and medication management~     for Swiss primary care. Investigators aime to assess the impact of the PMC extended with a~     semi-structured interview focusing on OAC.~   "
27006|NCT02703714|"~     This is an open label phase II trial to examine efficacy and safety of a novel combination~     of pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at~     UCSF.~      This phase II study will examine the efficacy and safety of the novel combination of~     pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses~     that the combination may increase proportion of patients with PFS6 compared to contemporary~     historical controls, with acceptable safety.~   "
27007|NCT02703701|"~     The United States spends over $8,000 per capita annually on health care and its health care~     system is more expensive than other developed countries. Even with high per capita costs and~     a high proportion of physician specialists, the US lags in health care performance from~     patients' perspectives.~      The hospital emergency department (ED) is often the portal of entry for patients seeking~     health care services and is therefore an ideal setting for initiatives to improve efficiency~     of care delivery and patient satisfaction. Reduction in wait times, enhanced information~     delivery and ED staff service quality all have a positive influence on patient perception of~     health care quality and satisfaction.~      Prior studies have attempted to increase patient satisfaction by improving staff~     communication and courtesy, implementing a patient satisfaction team in triage, and~     delivering information to patients in a timely manner. Another strategy to increase the~     efficiency of ED operations is adding a physician to triage to perform brief medical~     screenings and initiate necessary patient testing and treatment. This contrasts to usual~     practice in which physicians evaluate patients only following registration and nurse~     assessment of illness or injury severity.~   "
27008|NCT02703688|"~     Few treatments have been developed for young children with obesity from diverse backgrounds.~     The present study will develop and test an intervention designed to improve preschool~     obesity in Latino children. The intervention will focus on improving eating, activity, and~     sleep behaviors and the home environment for improved weight status.~   "
27009|NCT02703675|"~     Research has shown that lowering brain temperature may have good results in heart attack~     patients. Lowering brain temperature may be a promising treatment for stroke patients. The~     Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the~     neck. The device is a neck collar with a cooling pack which when shaken can reach low~     temperature within seconds. The collar is placed around the patient's neck and the cooling~     pack is applied to the front of the neck and held in place. This device provides stable~     cooling irrespective of participant size or weight. The objective of this study is to test~     the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different~     groups of adult participants:~      i. Healthy adult volunteers, ii. Adult participants with normal body temperature in~     intensive care unit iii. Adult participants with fever in intensive care unit~   "
27010|NCT02703662|"~     To date, there have been no prospective randomized controlled trials that compare various~     biologic mesh materials in the context of abdominal wall reconstruction. As a result, this~     proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the~     market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell~     Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a~     randomized manner. Although there are significant differences between these mesh products~     with regard to procurement, tissue processing and cost, clinical controlled trials are~     needed to compare their performance.~   "
27011|NCT02703649|"~     Letrozole is considered an established treatment for ovulation induction.The most common~     protocol is daily dose of 2.5-7.5 mg starting day 3-5 of the cycle for 5 days.Another~     described protocol is single high dose 20mg Letrozole given on day 3 of the cycle.~      Our aim is to compare the single high dose Letrozole protocol to daily low dose protocol.~   "
27012|NCT02703636|"~     To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function~     measured as change from baseline to week 24 in the total score of Mini-Mental State~     Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to~     benefit from other cholinesterase inhibitors (ChEIs).~   "
27067|NCT02702921|"~     This prospective, randomized, controlled, multi-center study will collect and compare data~     from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein~     transection) and powered vascular stapler.~   "
27015|NCT02703597|"~     Objectives:~      Objective 1: Conduct focus group discussions with 15 adolescents in order to design~     game-based social activities (GSA's) aiming to reduce smoking curiosity and increase~     positive connections.~      Objective 2: Through a short-term pilot evaluation, compare the use of a smoking prevention~     interactive experience (ASPIRE) alone (ASPIRE group) with the use of GSAs along with ASPIRE~     (GSA-ASPIRE group).~      Hypothesis 2.1: Adolescents in the GSA-ASPIRE group will be more likely to decrease in their~     intention to smoke, when compared with adolescents in the ASPIRE group.~      Hypothesis 2.2: Adolescents in the GSA-ASPIRE group will be more likely to (a) reduce in~     smoking curiosity and (b) engage in positive social influence, when compared with~     adolescents in the ASPIRE group.~      Exploratory hypothesis 2.3: (a) Smoking curiosity and (b) Positive social influence are~     related to the decrease in intention to smoke.~      Objective 3: Conduct in-depth interviews with 15 adolescents in order to obtain feedback on~     how GSAs can be best improved as part of future research.~   "
27016|NCT02703584|"~     All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the~     dual trigger are all retrospective. The investigators therefore aim to perform a prospective~     randomized controlled study in normal responders, comparing cycles triggered with hCG to~     those triggered with hCG+GnRH agonist.~   "
27017|NCT02703571|"~     Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose~     expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer.~     Open-label, nonrandomized.~   "
27018|NCT02703558|"~     This study is a prospective randomized controlled study. Female patients over 18 years of~     age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence~     at the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to~     undergo a urogynecologic surgical procedure, will be considered for inclusion in the study.~     Their histories will be reviewed by their attending surgeon and if they meet inclusion and~     exclusion criteria, they will be recruited for participation. The primary investigator and~     co-investigators (attending physician, fellows) will determine patient eligibility.~     Regarding privacy issues, the patients will be consented for both the procedure and for the~     study with careful attention made to emphasize patient confidentiality. When the patient~     presents for surgery, they will be randomized to receive either preoperative pyridium or~     intraoperative fluorescein or no dye. Given the color differences between the dyes, blinding~     will not occur. The process for recruitment will be consistent and any deviations from the~     protocol will be reported to the Johns Hopkins Internal Review Board.~   "
27019|NCT02703545|"~     Various centers around the world are currently investigating the feasibility and yield of~     surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to~     accumulate that surveillance may lead to the early detection of non-invasive precursor~     lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to~     reduce mortality in these high risk individuals, but before this can be confirmed many~     research questions need to be answered. While the numbers of high-risk individuals screened~     in each separate screening facility are likely too small to properly address many of these~     questions, pooling data comprises a sizable sample size providing unique research~     opportunities. The objective of this study is retrospectively review all cases of high-risk~     individuals participating in our pancreatic surveillance program in whom 1) a suspicious~     precursor lesions was detected for which a pancreatic resection was performed and 2) in whom~     an advanced malignant disease was diagnosed. The de-identified information will be entered~     into an international multicenter database registry.~   "
27020|NCT02703532|"~     The objective of this study is to identify the potential benefits of a home-based,~     intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation.~     Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive~     constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be~     randomized to traditional caregiver education or a web based intervention for the duration~     of stroke survivor therapy. By learning the best way to involve family members in therapy,~     investigators hope to decrease the harmful effects of stroke.~   "
27021|NCT02703519|"~     This prospective, controlled, clinical, intervention study measures the number of uterine~     Cesarean section scars and median myometrial thickness of women who underwent two Cesarean~     sections six to nine months after their last Cesarean section using transvaginal ultrasound.~      It is the purpose of the study to assess if a resection of the uterine scar from a previous~     Cesarean section during a second Cesarean section could lead to a decrease in risk for~     subsequent pregnancies.~   "
27022|NCT02703506|"~     This project aims to study the effectiveness of a pain education program in the improvement~     of chronic pain and disability/impairment. Assuming the definition established in the United~     States in 1975 on the fourth working group of the National Conference on Preventive~     Medicine: Health education must be a process that informs, motivates and helps people to~     adopt and maintain practices and healthy lifestyles, environmental advocates changes~     necessary to facilitate these objectives and professional training and directs research~     towards the same objectives.  Once the need of educating patients is stablished on subjects~     with diseases, it is necessary to encourage them to actively participate on the control of~     them and to achieve significant improvement of adherence~   "
27023|NCT02703493|"~     This is a Phase I study looking to evaluate the safety of dose escalated stereotactic~     radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk~     human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.~   "
27024|NCT02703480|"~     The proposed study design is a randomized controlled trial, split mouth design, to compare~     the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and~     Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene~     (d-PTFE) membrane.~   "
27025|NCT02703467|"~     The purpose of this study will be to determine whether there is any role for measuring~     Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with~     asthma.~      The investigators will recruit patients with a range of severity of asthma and health~     volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also~     exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study~     visit. Participants will attend either 2 or 4 separate visits.~      The investigators will determine whether there is a relationship between exhaled Hydrogen~     Sulphide and asthma severity.~   "
27027|NCT02703441|"~     The research and innovation programme Food´n´Go - Empower aims to develop, test and~     implement health technology solutions for active involvement and increased empowerment of~     elderly patients and their relatives solving well-known problem areas as malnutrition and~     inactivity.~      The prototype was developed in 2013. The project is a collaboration between departement of~     internal medicine in Copenhagen University Hospital, one local municipality and a private~     it-company. The technology is a tablet computer, used by elderly patients to order and~     register food intake during hospitalization. The tablet is also used to get inspiration for~     physical activities during hospital admission and after discharge and for registration of~     physical activities.~      The aim of this study is to test if an adjusted version of the Food´n´Go technology through~     active involvement of the elderly patient can prevent weightloss and loss of muscle strength~     during hospitalization and after discharge.~   "
27028|NCT02703428|"~     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center~     post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform~     when used in the endovascular treatment of female patients.~   "
27029|NCT02703415|"~     Management of acute pain is one of the most important tasks of perioperative pediatric~     anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia,~     on its 15th annual meeting as a basic human right, irrespective of age, treatment primary~     service responsible for the patient care. Pro-inflammatory cytokines increased by surgical~     trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen~     free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central~     sensitivity and hyperalgesia. There has been growing interest in determining the possible~     immune consequences of analgesic administration for the management of postoperative pain~   "
27030|NCT02703402|"~     ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of~     this syndrome is 60-85% for the survival of the individuals. Among the most promising~     strategies of low back pain intervention, is the physical activity that is usually~     associated with a long list of health benefits.~   "
27031|NCT02703389|"~     The amount and speed of emergency department (ED) discharge instructions often make it~     difficult for patients/caregivers to know the final diagnosis and to remember instructions.~     We hypothesize that a video on ear infections and antibiotics' role in their management will~     facilitate caregiver understanding and will increase the likelihood of caregivers properly~     following discharge instructions.~      To verify this hypothesis, a large multi-centre clinical trial is needed. Prior to this, it~     is only ethical to conduct a smaller 'pilot' trial. Previously healthy children (6 months-5~     years) diagnosed with mild ear infections at the McMaster Children's Hospital ED will be~     eligible to participate. If the child and caregiver decide to participate, before discharge,~     the caregiver will either: 1)watch the aforementioned video, 2)be given a pamphlet with the~     same information, or 3)standard of care (no additional information). Participants will fill~     a knowledge survey before discharge. The research assistant will contact all participants by~     phone to determine if the caregiver followed the discharge instructions.~   "
27032|NCT02703376|"~     This study is safety and proof-of-concept study for oral prednisolone in the treatment of~     esophageal stricture after esophageal surgery. The patients who develop the severe~     esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes~     are Safety and Success rate of this treatment.~   "
27033|NCT02703363|"~     Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients~     with bipolar disorder experience persistent depressive symptoms that do not respond to~     standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may~     reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central~     nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug~     in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor,~     has also shown promising results in the treatment of depressive symptoms. In this factorial~     design, double blind, randomised controlled trial the investigators will determine the~     efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in~     patients experiencing a depressive phase of bipolar I or II disorder. The investigators~     hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement~     in depressive symptoms in participants in comparison with placebo.~   "
27034|NCT02703350|"~     The study will be conducted in participants with type1 diabetes on insulin injection therapy~     to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar~     levels. Side effects and tolerability will be documented. The study will be conducted in two~     parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in~     both parts.~   "
27035|NCT02703337|"~     The study will be conducted in participants with type 2 diabetes on insulin injection~     therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood~     sugar levels. Side effects and tolerability will be documented. The study will be conducted~     in two parts (Part A and Part B) to achieve its objectives. Participants are expected to~     enroll in both parts.~   "
27036|NCT02703324|"~     This study will evaluate a blood sugar lowering insulin, LY900014, delivered by an insulin~     pump continuously under the skin. The study will be conducted in participants with type 1~     diabetes mellitus to investigate how the human body processes LY900014 and its effect on~     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability~     will be documented.~   "
27037|NCT02703311|"~     The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary~     (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed~     on the beating heart through a transseptal approach. The Cardioband is deployed along the~     posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance~     on the beating heart. A CE mark study with 30 subjects has been completed and documented~     reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in~     subjects with moderate to severe MR.~      Study objectives are to test the efficacy of the Cardioband in improving MR and heart~     failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class~     III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the~     Cardioband system in the post-marketing setting.~   "
27038|NCT02703298|"~     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer~     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer~     cell lines. The objectives of this study are to determine the safety profile of TRX-818~     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in~     Asians and determine the recommended dose and regimen(s) to initiate Phase 2.~   "
27039|NCT02703285|"~     The study aims to validate the interpretation of breath sounds by medical personnel~   "
27040|NCT02703272|"~     The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric~     participants is consistent with that in adults (part 1) and to assess efficacy (event-free~     survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and~     etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI)~     background therapy compared to RICE or RVICI background therapy alone (part 2).~   "
27041|NCT02703259|"~     The purpose of the investigators' study is to assess the efficacy of a single dose of~     preoperative gabapentin within an enhanced recovery after surgery protocol in acute~     postoperative pain reduction for women undergoing a minimally invasive hysterectomy.~     Participants who consent to participate will be randomized to either a control group without~     gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery.~     The investigators will collect data on postoperative narcotic use, subjective pain as rated~     by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.~   "
27042|NCT02703246|"~     In this study the investigators will perform a randomized trial to compare the surgical~     outcomes of vaginal versus abdominal morcellation of the uterus during hysterectomy. In~     minimally invasive gynecologic surgery small incisions are made in the abdomen and pelvis so~     that a hysterectomy can be performed by laparoscopy. The challenge is then to remove the~     uterus, which may be quite large, through these small incisions. One option is to morcellate~     the uterus and remove the tissue through either a small abdominal incision or an incision in~     the vagina. When an organ is morcellated it is cut into smaller pieces so that it can be~     removed, section by section, through a small incision. The investigators will compare these~     two methods of tissue removal to see whether one results in better surgical outcomes or~     increased intra-operative or post-operative complications. The primary outcome will be the~     time it takes to perform the surgery (operative time). Secondary surgical outcomes that will~     be studied include the amount of blood lost during surgery, post-operative complications,~     and readmission to the hospital.~   "
27043|NCT02703233|"~     This will be a randomized control trial. All patients for whom an emergency provider~     determines that abscess drainage or laceration repair are necessary will be considered for~     enrollment. The provider must be willing to participate in the study and be certified to use~     Nitrous oxide. The investigators providers completed a training course to be certified to~     use Nitrous oxide. The patient must be age 18 or greater, consent to participate in the~     study, and be able to complete a satisfaction survey. If the patient states there is a~     possibility of pregnancy, the investigators will regress to our standard of care and perform~     a urine pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients~     who agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be~     administered through the same system), and will complete a survey after the procedure, as~     will the provider. There will be a separate block randomization for each procedure.~     Providers may select other agents of choice for analgesia/sedation, such as local~     anesthesia, and pain medications, based on their clinical judgment. If the patient appears~     to have inadequate analgesia during the procedure, the provider can elect to treat as is~     typically done (pain medications or local anesthetics) at their discretion. The survey will~     ask patients to give a self-reported pain score before and during their procedure (both to~     be completed after the procedure). It will also ask the patient/guardian and provider for a~     satisfaction level with the analgesia during the procedure. In addition, side effects and~     procedure start and stop time will also be documented. In addition to the survey, the~     investigators will document clinical characteristics including diagnosis, size of laceration~     or abscess, additional medications required and dosages, comorbidities, age, and gender.~     Other data that will be gathered will include which adjunctive analgesics/anesthetics were~     used.~   "
27044|NCT02703220|"~     Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and~     leads to increased morbidity and mortality in this population. The proposal aims to identity~     whether oxygen, finasteride and acetazolamide can be effective in reducing unstable~     breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal~     will enhance the investigators' understanding of the pathways that contribute to the~     development of sleep apnea in the elderly. The investigators expect that the results~     obtained from this study will positively impact the health of Veterans by identifying new~     treatment modalities for sleep apnea. A cumulative effect of the investigators' research~     will fulfill the long-term goal of improving the quality of life of elderly Veterans~     suffering from sleep apnea and its potential life-threatening complications.~   "
27045|NCT02703207|"~     Cognitive dysfunction in the aging Veteran population is a growing health concern in the~     Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the~     risk for cognitive dysfunction. The investigators sought to investigate whether these two~     highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance~     cognitive impairment in the elderly Veteran population. Thus, the investigators will study~     whether elderly patients with Overlap syndrome have increased cognitive deficits compared~     with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP)~     has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive~     decline in COPD may be reversible through treatment with long-term oxygen therapy. The~     investigators will also study whether treatment with positive airway pressure (PAP) and~     supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life~     of elderly Veterans.~   "
27046|NCT02703194|"~     The study has been designed as a 12-month, open-label, randomized, controlled study~     comparing the use of prednisone mono-therapy and prednisone and leflunomide combination~     therapy in treating patients with IgG4-related disease.~   "
27047|NCT02703181|"~     The current study is designed to assess the safety, tolerability and pharmacokinetics (PK)~     of additional repeat doses of epelsiban in healthy females, and will be the first dosing~     experience of repeat dosing at higher doses in women with this compound.~      This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind),~     repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon~     successful completion of the Screening period, a subject will be enrolled in the study. The~     study will be composed of three periods: Screening, Treatment and Follow-up. A subject's~     total time involved in the study will be approximately six weeks.~      Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort.~     Ten subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo~     (n=2).~   "
27048|NCT02703168|"~     This is a follow-up study with patients, who participated in the Straumann clinical study~     CR06/03. The objective is the assessment of long-term data (8 and 10 years after~     implantation) on the performance of immediate and early (28-34 days post implantation)~     non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to~     support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and~     mandible.~      The primary objective is of the study is to analyse the change in crestal bone levels 8 and~     10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the~     immediate and early loading group.~   "
27049|NCT02703155|"~     The aim of this study is to establish if the self-administered electronic Oral Glucose~     Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are~     between 10 and 17 years of age with CF.~   "
27050|NCT02703142|"~     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical~     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and~     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic~     evaluation about reconstructive organs after esophagectomy. The investigators evaluate~     endoscopic predictions using classifications in acute phase after esophagogastrostomy.~   "
27051|NCT02703129|"~     Migraine is a common medical condition. Several studies suggest that obesity and/or weight~     gain are risk factors for aggravating migraine course, especially increase the frequency of~     headache episodes. The aim of the current study was to evaluate whether nutritional~     intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of~     patients with migraine.~   "
27052|NCT02703116|"~     The purpose of this study is to assess the feasibility, acceptability and test the initial~     efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with~     STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who~     have sex with men) and YTW (young transgender women) on frequency of substance use and~     engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis)~     care continuum.~   "
27053|NCT02703103|"~     The aim of the study was to evaluate the new mechanical chest compression machine LifeLine~     ARM in healthcare professionals in simulated model of cardiac arrest.~   "
27054|NCT02703090|"~     The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general~     anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices~     and the prefrontal cortices in response to noxious stimulation.~   "
27055|NCT02703077|"~     This study compare 2 techniques to treat difficult bile duct stones endoscopically~   "
27056|NCT02703064|"~     Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of~     reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a~     hormonal disorder that involves multiple organ systems within the body. Its cardinal~     features are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may~     complains about irregular menstrual periods or heavy menstrual bleeding, infertility,~     excessive growth of coarse facial and body hair, obesity, oiliness of the skin, seborrhea,~     and cystic acne.~   "
27057|NCT02703051|"~     Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study~     conducted at one study center in the United States (US).~   "
27058|NCT02703038|"~     Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output.~     Catches diagnostic management, and therapeutic monitoring of these patients remain highly~     variable from one center to another and even from one doctor to another within the same~     team. The management protocols are often not standardized or non-existent.~      It appears therefore necessary to make an inventory of the management practices of the CS in~     France in 2016, prerequisite to a common work of standardization of practices and the~     creation of specialized networks to support these complex patients.~   "
27059|NCT02703025|"~     Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study~   "
27060|NCT02703012|"~     First clinical application of an algorithm for individual adjustment of ventilator settings~     using electrical impedance tomography.~   "
27061|NCT02702999|"~     The purpose of this study is to see whether women at a gestational age of 30 weeks or more~     without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase~     the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared~     with women who only receive indicated ultrasounds?~   "
27062|NCT02702986|"~     10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant~     treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating~     Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated~     as primary objective. Secondary objectives will be QoL after imILT, study of the immune~     reaction after imILT, oncological analysis of patients suffering from LAPC submitted to~     imILT.~   "
27063|NCT02702973|"~     The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced~     retinopathy, especially in the patients with hypertension or diabetes, so these patients~     should be followed up after treatment.~   "
27064|NCT02702960|"~     This trial is a phase II, single arm, open-label, single center study to assess a~     reduced-intensity conditioning regimen, bone marrow transplantation and high dose PTCy in~     recipients of a partial liver allograft from a Human Leukocyte Antigen (HLA)-matched or~     -haploidentical living related donor in patients with HCC.~      The primary objective of this trial is to characterize recurrence-free survival at 1 year~     following bone marrow transplantation among recipients of prior partial liver~     transplantation from the same donor.~   "
27065|NCT02702947|"~     Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus~     domestica bark contains three groups of active constituents: phytosterols (including~     beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic~     esters of long-chain fatty alcohols (including ferulic esters of docosanol and~     tetracosanol).~      The phytosterols, particularly beta-sitosterol, are found in numerous plants and are~     anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been~     shown to be useful in cases of BPH by helping to reduce the normally elevated levels of~     prostaglandins in these patients.~   "
27066|NCT02702934|"~     Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized~     controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based~     rusks in overweight subjects.~   "
27069|NCT02702895|"~     MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize~     qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore~     socio-contextual and trial specific issues which affected participants' adherence to the~     dapivirine vaginal ring (VR).~   "
27070|NCT02702882|"~     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of~     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek~     seeds extract are known to possess protodioscin and the extract is reported to improve sperm~     count, sperm morphology and protective effect on male reproductive system. All the~     participants will receive one capsule (500 mg) of furosap once a day.~   "
27071|NCT02702869|"~     A system for prospective data-collection is being implemented by the Duke Cleft &~     Craniofacial Center so that it may analyze clinical and psychosocial outcomes related to~     care of the child with cleft lip and/or palate (CL/P), compare its performance with those of~     other cleft centers, and identify opportunities for quality improvement.~   "
27072|NCT02702856|"~     Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude~     the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle~     biopsy.~   "
27073|NCT02702843|"~     The Study is designed to compare the effectiveness of Near Infrared Fluorescence~     Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying~     the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic~     Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory~     Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs~     better than standard white light (WLI) alone in visualizing and identifying~     extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common~     Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before~     and after dissection during Laparoscopic Cholecystectomy (LC).~   "
27074|NCT02702830|"~     This pilot research trial studies magnetic resonance imaging (MRI) and cardio~     (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients~     with stage I-III breast cancer after treatment with chemotherapy drugs called~     anthracyclines. Anthracyclines are related with heart problems, cardiac abnormalities, bone~     and muscle dysfunction. Patients with breast cancer who are exposed to anthracycline drugs~     may also experience progressive fatigue and exercise intolerance which may limit daily~     activities and is an important barrier for patients returning to work. Using MRI and~     cardio-pulmonary exercise testing (CPET) may help doctors understand the causes of fatigue~     and exercise intolerance in patients receiving anthracycline chemotherapy and this may also~     allow doctors to plan better treatments to protect patients' heart, cardiovascular system,~     bone and muscle function.~   "
27075|NCT02702817|"~     Two-year double-masked trial of over-the-counter dosage of naproxen sodium vs placebo in 200~     cognitively normal participants with a parental or multiplex first-degree family history~     Alzheimer's disease (AD) dementia. Primary outcomes are decline in cognitive function and~     slope of change in a summary Alzheimer Progression Score derived from serial assessment of~     neuroimaging, biochemical, and sensori-neural biomarker indicators of pre-clinical disease~     -- all believed likely to reflect progress of preclinical AD in this high risk cohort.~     Approximately 2/3 of participants have volunteered also for serial lumbar punctures for~     analysis of cerebrospinal fluid. A two-year off-treatment delayed-washout phase is planned~     to examine sustained treatment effects and evidence of disease modification.~   "
27076|NCT02702804|"~     Exercise has been shown to improve quality of life in people with multiple sclerosis but~     most exercise programmes are carried out at low to moderate intensities. The next stage in~     the management of the condition is to establish if people with mild Multiple Sclerosis can~     exercise, safely and effectively at a higher intensity. High intensity interval training~     (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High~     intensity interval trainingcould be a time efficient and safe option for people with~     Multiple Sclerosis. Potential improvements are; cardiovascular fitness, resistance to~     fatigue, balance, quality of life and attitude to physical exercise.~      Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10~     sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential~     participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an~     EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2~     years.~      From this study the investigators hope to discover if High Intensity Interval Training is a~     safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This~     will then hopefully lead to further large research trials.~   "
27077|NCT02702791|"~     This randomized control trial will investigate whether the implementation of a telecoaching~     program, initiated during pulmonary rehabilitation, is able to increase and maintain~     physical activity and general benefits until six months after rehabilitation discharge.~      After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be~     randomized to either an intervention group which receives an additional telecoaching program~     on top of the pulmonary rehabilitation, or to the usual care group, which only receives~     rehabilitation program. Apart from the added telecoaching program to the intervention group,~     the rehabilitation program will be identical and last for another three months (2 times a~     week). After discharge, both groups will be followed up for six months.~   "
27078|NCT02702778|"~     A four-week, randomized, controlled, open-label trial of DR prednisone in which patients~     receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two~     weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two~     weeks. Period 1 is randomized and open-label and period 2 is open label. Before enrollment~     and randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning~     is established. 45 patients will be randomized, 15 patients in each treatment arm.~   "
27079|NCT02702765|"~     The aim is to investigate macrophage activation markers and correlations to liver fibrosis~     in patients with Wilsons Disease. Researchers wish to investigate associations to neurologic~     and metabolic liver function. Researchers will assess this by comparing blood samples with~     fibrosis and liver function analyses. This study provides new insight into macrophages and~     their involvement in Wilsons Disease.~   "
29250|NCT02674282|"~     Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer~     players and after a six-month period of post-operative rehabilitation, compared to a control~     group of healthy professional soccer players.~   "
27080|NCT02702752|"~     The aims of the present study are to measure dynamic changes over time in the plasma level~     of SDF-1α in patients with confirmed diagnoses of AMI, AF and CHF and in so doing:~        1. Monitor the plasma level of SDF-1α at the diagnosis, during and after the long term~          treatment of AMI, AF and CHF. The SDF-1α level of patients is expected to decrease~          during treatment of the aforementioned conditions.~        2. Correlate the plasma level of SDF-1α in relation to clinical, biochemical~          characteristics of Acute Myocardial Infarction(AMI), Atrial Fibrillation(AF) and~          Congestive Heart Failure (CHF). In so doing, the investigators expect that SDF-1α will~          correlate with the severity of heart disease.~        3. Study the dynamic of SDF-1α pertaining to its property as prognostic indicator for the~          long term follow up risk of readmission and mortality of patients diagnosed with AMI,~          AF or CHF.~   "
27081|NCT02702739|"~     The proportion of HCV infected patients over age 65 years in Western countries is~     increasing. This growth and the advent of new antiviral therapy bring into the question the~     real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV)~     plus a flat dose of ribavirin (RBV) in elderly patients compared to younger patients.~   "
27082|NCT02702726|"~     The aim of this study is to compare the effects of dietary fats, ingested in two physical~     forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI~     18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.~   "
27083|NCT02702713|"~     This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary~     intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be~     recruited. Subjects will be eligible to the study if they present with two to four of the MS~     diagnostic criteria, at least one of them being:~        -  fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR~        -  HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110~          mg/dL).~      Each of the four recruiting centres will recruit 200 volunteers. Participants will be~     randomly assigned to one of four groups to receive either:~        -  Dairy BEF + egg placebo + bakery placebo~        -  Egg BEF + dairy placebo + bakery placebo~        -  Bakery BEF + dairy placebo + egg placebo~        -  Dairy, egg and bakery placebo~      Participants will be required to consume all three of the allocated products each day for 12~     weeks.~      Eligible volunteers will be included and randomly allocated to one of the four groups. At~     baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting~     centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will~     complete questionnaires relating to their satisfaction with the food products, compliance to~     consumption of the study food products, and any gastrointestinal side effects or~     health-related adverse events that have occurred in the previous 3 weeks.~      At each recruiting centre 40 participants will be required to take part in additional~     activities, these are: stool sample collection, adipose tissue aspiration, body composition~     analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.~   "
27084|NCT02702700|"~     This clinical study aims to explore intrapleural low-dose Visudyne®-mediated photodynamic~     therapy (photo-induction) as a pathway to promote the uptake of systemically administered~     Lipoplatin™ in pleural malignancies of patients undergoing video-assisted talcage for their~     malignant pleural effusions. Photo-induction is expected to overcome the chemo-resistance of~     pleural malignancies for cisplatin-based chemotherapeutics and thereby improve local tumor~     control.~   "
27085|NCT02702687|"~     This randomized controlled trial will include Latino and Black adolescents with asthma ages~     10-17 years old and their caregivers. Participants will be recruited from clinics in the~     Bronx, NY. The primary aims are to examine the efficacy of peak expiratory flow (PEF)~     prediction with feedback versus control feedback on 1) under-perception of asthma symptoms~     2) controller medication adherence and 3) asthma control and emergency health care use.~     These aims will be examined across a 1-year follow-up. An exploratory aim examines the~     hypothesized pathway that the PEF intervention reduces under-perception of symptoms, shifts~     illness representations toward the professional model and increases adolescents' and~     parents' asthma management self-efficacy, resulting in greater medication adherence and~     improved asthma control.~   "
27086|NCT02702674|"~     The effect of coadministration of oral propranolol to oxytocin on induction of labor.~   "
27087|NCT02702661|"~     A prospective randomised controlled trial involving patients undergoing hip arthroscopy.~     Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or~     Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic.~     Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is~     assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the~     post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery.~     Secondary outcome measures were the frequency and the dose of morphine and other medications~     consumed at 1 and 24 hours after surgery as well as any other adverse events relating to~     pain or medications used for pain relief in both the groups.~   "
27088|NCT02702648|"~     The primary purpose of this first-in-man study is to investigate whether a new drug for~     neurological disorders is safe and well-tolerated when administered orally to healthy adults~   "
27089|NCT02702635|"~     Dynamic contrast-enhanced (DCE) MRI gives quantitative and semi-quantitative information~     about the integrity of the vascular system and can be used to quantify blood-brain barrier~     (BBB) integrity. The BBB plays a pathophysiological role in diabetes, cognitive disorders~     such as mild cognitive impairment, Alzheimer's disease, multiple sclerosis, and chronic~     traumatic encephalopathy. Although dysfunctional, changes in BBB integrity for these~     conditions are thought to be subtle and close to intact values. Recent studies have shown it~     is possible measure small changes in the BBB integrity as an early sign of disease using DCE~     MRI. The objective of this study is to apply an optimized DCE imaging protocol and novel~     image post-processing to obtain new information about the BBB integrity in trauma. These~     techniques show promise for both improving clinical diagnosis, and elucidated the physiology~     or various disease processes.~   "
27090|NCT02702622|"~     The objective will be to quantify the vitamin A equivalence of the provitamin A in~     transgenic biofortified bananas.~   "
27091|NCT02702609|"~     Randomized Controlled study to compare the effectiveness of two different treatment~     approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge~     preservation of an atraumatic extraction socket site compared to allograft with collagen~     plug.~   "
27092|NCT02702596|"~     The proposed study seeks to establish the feasibility of universal screening for depression~     in an adult primary care safety net setting, measure the effectiveness of a culturally~     appropriate depression education intervention to reduce stigma and increase uptake in~     depression treatment among Hispanics, and implement a Measurement-Based Integrated Care~     (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care~     management strategies.~   "
27093|NCT02702583|"~     Febrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive~     chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of~     origin of infection: the airways, urinary tracts, and skin. However, infections can be only~     documented clinically in about two-third of febrile episodes, whereas a causative microbial~     pathogen cannot be identified in the majority (>70%) of cases.~      Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only~     routinely used in patients at high risk for oral complications (i.e. head and neck cancer~     patients and stem cell transplantation recipients). However, any patient treated with~     myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing~     infection in and/or originating from the oral cavity. Nevertheless, in these patients dental~     screening is somewhat randomly employed at the oncologist's discretion.~      More insight into the pre-treatment oral condition and its potential role in FN is~     mandatory, particularly considering the growing numbers of older patients retaining their~     natural dentition and the increase of dental diseases and cancer incidence with age.~      In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is~     associated with an inflammatory response, which together with ulcerations providing a portal~     of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or~     sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no~     longitudinal studies using open-end sequencing are available.~      Furthermore, comparing bacteria identified in blood cultures in febrile patients with those~     of the oral cavity will expand the knowledge on the role of the oral cavity as a potential~     source of bacteremia.~      The investigators expect that the results will provide a scientific base for subsequent~     intervention studies on the efficacy of dental screening and elimination of foci, and other~     interventions aimed at modifying the oral environment before and during chemotherapy.~   "
27094|NCT02702570|"~     The investigators are planning to recruit approximately 30 study participants aged 50 years~     and older that will undergo a 4 week attention and emotion regulation intervention. The~     intervention systematically targets thoughts, emotions and behavior in order to promote~     quality of life and advance successful brain aging. The investigators will assess the~     feasibility of recruiting and retaining participants for an attention and emotion regulation~     intervention. In addition, the investigators will determine the efficacy of the intervention~     to enhance and promote quality of life, sustained attention, emotions, motivation and~     cognitive health.~   "
27095|NCT02702557|"~     This feasibility study investigates if frail elderly and hospitalized patients are able to~     perform unsupervised elastic band exercises as a supplement to their usual supervised~     physiotherapy sessions and how much training they perform during their hospitalization. It~     is also investigated how the frail elderly and the health personnel experiences the~     unsupervised elastic band exercises.~   "
27096|NCT02702544|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke~     Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a~     impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis.~     GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.~   "
27097|NCT02702531|"~     Endoscopic surgical procedures are becoming more common in all surgical specialties~     including gynecology that was one of the pioneers in this field specialties.~      Maintaining a quality field of view is important not only to patient safety but also for the~     quality of surgery and reduced surgery time.~      The lenses of vision which are located at the distal end of the optical vision are during~     endoscopic surgery in direct contact with the anatomical structures. These lenses are found~     soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to~     a clear field.~      The alteration of the vision requires the surgeon extraction optics in order to achieve a~     cleaning of the lens. This cleaning is carried out as many times as necessary. Many~     strategies have been developed to improve the quality of vision. These methods relate to~     both the development of new optical vision but also the development of the lens cleaning~     material. In practice, the cleaning is carried out using a sterile swab sterile saline~     associated with the betadine iodine.~      Recently a new material called FloShield Air System Vision System has been proposed and~     has the particularity to combine both anti-fog product and a temperature control system in~     contact with the lens in order to fight against condensation and smoke. The purpose of this~     is to improve the quality of vision by reducing the fogging phenomenon and no change of the~     temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a~     reduction in the number of stay and a reduction in the specific operative time associated~     with this cleaning.~      In this context, we wish to evaluate the effectiveness of FloShield Air System vision system~     on the basis of a comparative, prospective, randomized against the reference method (sterile~     water solution + Betadine) during endoscopic surgery gynecology.~   "
27098|NCT02702518|"~     The purpose of this study is to evaluate the tolerability and preliminary efficacy of~     rhDNase I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).~   "
27099|NCT02702505|"~     Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use~     in vital teeth has demonstrated significant color change post-treatment leaving it~     ineffective for esthetic use..~      The new formulation will be tested to see if has the same effect.~   "
27100|NCT02702492|"~     This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the~     treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).~   "
27101|NCT02702479|"~     The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its~     introduction as a popular sweetener in the United States has led to much concern regarding~     its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic~     disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound~     by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound)~     form (4). Despite these differences in composition, both sugars possess identical energy~     contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose~     in HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk,~     more so than sucrose, through proposed differences in fructose metabolism, endocrine and~     hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to~     assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on~     cardiometabolic risk.~   "
27102|NCT02702466|"~     The main objective of this work is to demonstrate superiority to three months of a~     standardized short course of SPA Therapy of 6 days associated with personalized health~     education program compared to conventional therapy in the management of MSDs on the~     functional capabilities of the employees in their daily lives (personal or professional)~   "
27271|NCT02700256|"~     The purpose of this pilot study is to find out if patients are willing to self-report~     symptoms in the first 5 days following discharge, or when they leave the hospital after~     ambulatory surgery (ambulatory surgery is when the patient has surgery and then goes~     home within 24 hours).~   "
27103|NCT02702453|"~     There is increasing evidence that sexual activity is associated with greater resilience and~     higher well-being in older adults. Even at a time of stress, and even during a late stage of~     illness, men and their partners turn to sexual intimacy to increase a sense of connection,~     comfort and support. The Sexual Recovery intervention seeks to address an unmet need of~     prostate cancer survivors and their partners who are at risk for poor mental health and~     decreased quality of life as a result of sexual dysfunction.~      By using technology, the intervention will be widely accessible to survivors, the majority~     of whom do not currently have any access to sexual health expertise. The content and format~     of the intervention seeks to empower prostate cancer survivors and partners with knowledge~     and strategies to improve their sexual function, sexual confidence and their sexual~     relationship. The intervention begins prior to and continues following their definitive~     treatment. This may, in turn, improve mental health and quality of life.~      In a broader sense, this intervention will be transferable. With appropriate modifications,~     it can become an accessible sexual health intervention for populations dealing with other~     cancers and chronic illnesses.~   "
27104|NCT02702440|"~     Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of~     overweight and obesity. The most prominent mechanism to explain the link between SSBs and~     obesity is that liquid calories are not perceived by the body; thereby, promoting less~     satiety, less energy compensation and more weight gain than does the same energy consumed in~     solid form. This view is supported by pooled analyses of acute preload trials that have~     primarily measured food intake as the outcome. Though failure of short-term compensation has~     been observed with liquid calories, results from these acute preload trials should not be~     extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To~     date, it is unclear whether liquid calories have differential effects than solid calories on~     body weight gain over the longer term. To increase clarity in this issue, the investigators~     propose to conduct a systematic review and meta-analysis from long-term controlled feeding~     trials to distinguish the contribution of liquid calories from solid calories on body weight~     over the long-term. The findings generated by this analysis will improve the health of~     consumers through informing evidence-based guidelines and improving health outcomes by~     educating healthcare providers and patients, stimulating industry innovation, and guiding~     future research design.~   "
27105|NCT02702427|"~     Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are~     treated with virusspecific donor derived or autologous virusspecific T-cells.~   "
27106|NCT02702414|"~     This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in~     participants with previously systemically treated hepatocellular carcinoma (HCC). Study~     participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up~     to approximately 2 years).~      The primary objective of this study is to determine the Objective Response Rate (ORR) of~     pembrolizumab given as monotherapy in participants with previously systemically treated HCC~   "
27107|NCT02702401|"~     This is a study of pembrolizumab (MK-3475) in participants with previously systemically~     treated advanced hepatocellular carcinoma (HCC).~      The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and~     2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with~     placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC~     prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, assessed by a~     blinded central imaging vendor compared to placebo plus BSC, and 2) pembrolizumab plus BSC~     improves OS compared with placebo plus BSC.~   "
27108|NCT02702388|"~     This is a multicenter, randomized, double-blind study being conducted as a postmarketing~     requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a~     lower starting dosage of lenvatinib other than the approved 24 mg once daily (QD) that~     provides comparable efficacy but has a better safety profile in participants with RR-DTC~     with radiographic evidence of disease progression within the prior 12 months.~   "
27109|NCT02702375|"~     There is an urgent need for stronger evidence to support recommendations for the role of~     sugars in diabetes and related cardiometabolic diseases. Although large prospective cohort~     studies have shown a significant positive association of fructose-containing~     sugars-sweetened beverages with incident obesity, diabetes, heart disease, and stroke, these~     associations do not appear to hold true for total fructose-containing sugars and other~     important sources of free fructose-containing sugars such as pure fruit juice, yogurt, or~     even cakes and sweets. As dietary guidelines have moved away from macronutrient centric~     recommendations towards more food and dietary-pattern based recommendations, this~     inconsistency in the data has not been appreciated. There remains a focus on free sugars, in~     the absence of sufficient information on the role of different food sources of~     fructose-containing sugars in diabetes and related cardiometabolic diseases. A systematic~     review and meta-analysis of prospective cohort studies is considered to be the Gold~     Standard of evidence. To provide evidence-based guidance to support the development of~     public health policy in relation sugars and the primary prevention of diabetes, we will~     conduct a series of systematic reviews and meta-analyses of the relation of food sources of~     fructose-containing sugars with incident type 2 diabetes and related cardiometabolic~     diseases in prospective cohort studies.~   "
27110|NCT02702362|"~     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5~     consecutive days in chronic patients in minimally conscious state (MCS).~   "
27111|NCT02702349|"~     The incidence of reactions during penicillin challenge tests among children with suspected~     penicillin allergy~   "
27154|NCT02701777|"~     The overall goal is to develop new clinical approaches to restore upper-limb function after~     incomplete cervical spinal cord injury (SCI). Corticospinal tract (CST) axons are involved~     in controlling upper-limb function. Paired pulse induced spike-timing dependent plasticity~     (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs)~     resulting in temporary improvements in upper-limb function in humans with incomplete~     cervical SCI. Motor training will be combined with paired-pulse STDP stimulation to further~     enhance plasticity and behavioral recovery.~   "
27272|NCT02700243|"~     In this research study the investigators want to learn more about whether using a fitness~     tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and~     in turn whether it increases exercise tolerance over the period of one year.~   "
27112|NCT02702336|"~     The primary aim is to promote healthy lifestyles among young people, through the design and~     implementation of health promotion activities carried out by adolescents (12-14 years old)~     to scholars of primary education (8-10 years old), using social marketing and peer-led~     strategy.~      The secondary aims are: 1) to increase fruit and vegetable consumption and physical activity~     practice in scholars and adolescents; 2) to reduce sedentary lifestyles, sugary drinks and~     fast-food in scholars and adolescents.~      The EYTO-kids program is a randomized, parallel, intervention program with control group,~     with a 2 academic courses, 2015-2016 to 2016-2017 (10 months in total), in Reus (Spain).~      To achieve the aims, social marketing and peer-led methodologies will be used at the~     intervention design and implementation. Adolescents from secondary education (1st /2nd ESO:~     Educación Secundaria Obligatoria-Obligatory Secondary Education) will design and implement~     activities to scholars from primary education (3rd/4th primary education).~      The adolescents from the intervention group will design and implement activities to~     implement them in to children, and the control group will not receive any kind of~     intervention (only the assessment).~      Participation will occur according to the randomized sample size, where a minimum of 208~     adolescents (104 as intervention and 104 as control group), and 602 scholars (301 as~     intervention and 301 as control group) will be involved.~      The inclusion criteria are: to have signed informed consent (from mother/father/guardian of~     the participant), to provide basic demographic data, to assist participating schools and to~     answer a lifestyle questionnaire.~   "
27113|NCT02702323|"~     This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with~     pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib~     and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other~     half will receive TACE therapy alone.~   "
27114|NCT02702310|"~     This clinical trial studies low- dose total skin electron therapy in treating patients with~     stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or~     has returned after a period of improvement (relapsed). Radiation therapy uses high energy~     electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which~     the patient receives total skin electron therapy while standing on a rotating platform.~     Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells,~     while having fewer side effects, and may allow therapy to be repeated in future if~     clinically indicated.~   "
27115|NCT02702297|"~     The purpose of this study is to examine whether the value of vaginal fluid cytokine levels~     as well as computerized fetal ECG analysis are suitable clinical parameters to detect an~     imminent intra-amniotic inflammation with a high risk of fetal inflammatory response~     syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be~     determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.~   "
27116|NCT02702284|"~     The ability to communicate with patients is profoundly impacted by their health literacy -~     the ability to interpret documents, read and write prose, use quantitative information and~     speak and listen effectively. Limited health literacy is commonplace and associated with~     multiple poor health outcomes including frequent readmission's and high mortality. Advance~     directives are an important tool in respecting patient autonomy in health care~     interventions. Advance directives can also reduce health care costs by avoiding unwanted,~     unnecessary care at the end of life. At the University of Florida (UF) Health currently an~     initiative is underway to improve the delivery of advance directives to patients in the~     hospital as well as the outpatient clinics.~      The aim of this research study is to enhance completion rates of advance directives by~     taking into consideration a patient's health literacy level. Specifically, the investigators~     plan to assess the impact of an ambulatory intervention on the completion rate of advance~     directives for patients with adequate and limited health literacy. The hypothesis is that~     both groups (adequate and limited health literacy) will benefit from the intervention, but~     patients with limited health literacy will show a greater improvement in the advance~     directives completion rate.~   "
27117|NCT02702271|"~     The study is a prospective, non-randomized, multi-center investigation to establish the~     safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for~     subjects with non-valvular atrial fibrillation who are eligible for long-term~     anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a~     non-pharmacologic alternative.~   "
27118|NCT02702258|"~     Specific aims are:~        1. To outline and evaluate key active elements of the Mindfulness-Based Blood Pressure~          Reduction (MB-BP) intervention. This aim will be achieved using (a) focus groups of~          participants undergoing the MB-BP intervention, (b) discussion with experts (including~          cardiologists, epidemiologists, mindfulness experts, mindfulness intervention~          instructors) prior to, and following pilot testing of MBHT in participants, and (c)~          clinical judgment of the investigators performing the intervention.~        2. To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and~          longevity of target engagement (follow-up time-points). Follow-up time periods include~          10 weeks, 6 months and 1 year.~      This study is a prospective single-arm trial during the intervention development phase.~     Following this phase, after the intervention has been further developed, a subsequent study~     (with a different clinicaltrials.gov ID #) will utilize a randomized control trial design to~     further evaluate causation and effect size.~   "
27119|NCT02702245|"~     This cross-over intervention study aims to investigate the effect of two doses of thylakoids~     to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as~     appetite regulating hormones in healthy volunteers.~   "
27120|NCT02702232|"~     Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly~     recognized in our ageing population. It is characterized by cardinal clinical features~     including bradykinesia, tremor, rigidity, and postural instability. For most people with PD,~     the most serious concern is with the motor system: stiffness, slowness of movement, impaired~     handwriting and coordination, poor mobility and balance. However, more than half of all~     people with PD have experienced painful symptoms. Most people experience aching, stiffness,~     numbness and tingling at some point in the course of the illness. Defazio et al reported~     that pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5~     Aching muscles and joints are especially common in PD. Rigidity, lack of spontaneous~     movement, abnormalities of posture and awkward mechanical stresses all contribute to~     musculoskeletal pain in PD.~   "
27121|NCT02702219|"~     Mobility training in the form of stretching and flexibility training of our skeletal muscle~     is a common exercise. However, the evidence are scare and there are only a few studies~     comparing the effect of prolonged static stretching (> 90 sec) and dynamic flexibility~     training as to which of these methods has the best length-enhancing effect over time.~     Further, in clinical practice concerning low back pain, the possibility of a thigh~     hamstrings muscles to affect movement control of the spine is often mentioned, a link not~     fully explored in a controlled condition. The purpose of this study is to compare the effect~     of eight weeks of dynamic flexibility training versus prolonged static stretching on~     mobility in the hamstring muscles in adults with reduced mobility in the muscles at the back~     of the thigh. The aim is also to compare the sustained effect of flexibility training~     between the two groups, eight weeks after completion of the intervention. Furthermore, the~     aim is to explore how different forms of flexibility training affects movement patterns of~     the lumbar spine in adult persons with reduced mobility in the hamstrings.~   "
27122|NCT02702206|"~     A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or~     corticosteroid injections in patients with chronic subacromial bursitis.~   "
27123|NCT02702193|"~     The study conducts a community-based randomized trial comparing an adaptation of Structural~     Ecosystems Therapy (SET), Healthy Home, as an enhancement of substance abuse or mental~     health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172~     Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or~     mental health services. The study is conducted with a community partner, Banyan Health~     Systems, that delivers substance abuse/mental health treatment and primary care. Data is~     collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the~     proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and~     mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2)~     test the effectiveness of Healthy Home for improving health and mental health outcomes of~     children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care,~     environmental risk, family functioning and stigma); 4) assess implementation and~     sustainability factors and the relationship between fidelity and outcomes; and 5) examine~     the interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a~     manualized, strength-based, directive and process oriented family ecosystemic home health~     intervention developed to address the needs of mothers and their children affected by~     substance abuse and other mental health disorders.~   "
27124|NCT02702180|"~     This study evaluates inhaled molgramostim (recombinant human (rh) Granulocyte~     Macrophage-Colony Stimulating Factor (GM-CSF)) in the treatment of autoimmune pulmonary~     alveolar proteinosis patients. A third of the patients will receive inhaled molgramostim~     daily for 24 weeks, a third will receive inhaled molgramostim every other day for 24 weeks~     and a third will receive inhaled matching placebo for 24 weeks~   "
27125|NCT02702167|"~     This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive~     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered~     twice daily over 15 days, in patients with a diagnosis of bulimia or anorexia nervosa. The~     trial will include structural and functional MRI, EEG, and behavioral measures obtained~     before, during, and after treatment.~   "
27126|NCT02702154|"~     This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive~     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered~     twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The~     trial will include structural and functional MRI, EEG, and behavioral measures obtained~     before, during, and after treatment.~   "
27127|NCT02702141|"~     The study will examine the safety profile of SGN-CD19B administered as a single agent. The~     main purpose of the study is to estimate the highest dose that does not cause unacceptable~     side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell~     non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3~     follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity~     of SGN-CD19B will be assessed.~   "
27128|NCT02702128|"~     Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to~     compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism~     surgery.~   "
27129|NCT02702115|"~     The purpose of the study is to evaluate the safety, tolerability of ascending doses of~     SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for~     genome editing. It inserts a correct copy of the α-L-iduronidase (IDUA) gene into the~     Albumin locus in hepatocytes with the goal of lifelong therapeutic production of the IDUA~     enzyme.~   "
27130|NCT02702102|"~     This study uses a special type of scan called a positron emission tomography (PET) scan to~     take pictures of the brain. During the PET scan, a special dye called 11C-PBR28 is injected~     into the body.~      11C-PBR28 sticks to parts of the brain where there is inflammation. The purpose of this~     study is to see if 11C-PBR28 can detect inflammation in patients with Parkinson's disease~     dementia or dementia with Lewy bodies.~      11C-PBR28 is considered a drug by the Food and Drug Administration. 11C-PBR28 is not a~     treatment for any disease. Rather, 11C-PBR28 can be used to measure inflammation in the~     brain.~   "
27141|NCT02701959|"~     Leafy vegetables are a natural source of dietary nitrate, which may reduce systolic blood~     pressure (BP). However, the evidence has been obtained from studies using nitrate solutions~     (i.e., potassium or sodium nitrate) or beetroot juice supplementation which have a suitable~     placebo for the design of double-blind clinical trials. However, the design of food-based~     nutritional interventions is complicated by the fact that an appropriate placebo treatment~     is not available and, therefore, it is not possible to meet the criteria for proper~     double-blind randomised placebo-controlled intervention trials. In addition, the biological~     effects of processed products such as beetroot juice or solutions with a pharmacological~     grade may be different from that of fresh vegetables, e.g. due to conversion of nitrate to~     nitrite in the mouth during chewing.~      Objectives: to investigate whether two sets of lettuce specifically grown with different~     nitrate content but otherwise similar composition show different effects on nitrate uptake~     and bioavailability in humans. Additionally, the investigators also aim to design human~     intervention studies to investigate the effect of intake of lettuce with different nitrate~     content on vascular health.~      These objectives will be tested by growing lettuce with different fertiliser compositions~     resulting in high and low nitrate content and then investigating the bioavailability and~     short-term effect on BP in healthy young volunteers in a double-blind cross-over design.~     Eligible subjects will consume one meal each of either low or high nitrate lettuce. Urine,~     blood and saliva samples will be collected at baseline, for 6 hours after the ingestion and~     then again after 24hr. Blood Pressure BP will be measured continuously for 24 hours starting~     at baseline. The volunteers will repeat the intervention with the second treatment.~   "
27131|NCT02702089|"~     14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients~     represent a rising proportion of these patients. Whilst the gold standard is often to remove~     the tumour and restore bowel continuity, surgeons will often avoid this procedure in this~     group of patients as they unfortunately tolerate surgical complications very poorly. Such~     surgical complications may present with life threatening sepsis, can prolong hospital stay,~     delay further cancer therapy and in the elderly or frail patient often leads to loss of~     independence and quality of life. In this setting, there are two alternative procedures~     (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in~     roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is~     anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications~     (30%) and a few small retrospective studies have shown this (1-3), however there are no~     prospective data to support this view. Whilst some surgeons do choose intersphincteric APE~     (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived~     limitations in the technique (longer operating time, risk of tumour perforation), which are~     unproven. We feel that a larger, prospective dataset is required to demonstrate the~     superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have~     explored the possibility of a full randomised trial to answer this question, however this is~     not feasible due to the difficulty of randomisation of patients. Very little data are~     available regarding the use of IAPE in the setting of rectal cancer, however many surgeons~     who do employ the technique, specifically adapt their technique in this setting to reduce~     the chances of tumour perforation (two stage, stapling off rectum before removing anal canal~     separately). It is possible that those surgeons who prefer HP have not considered this, and~     combined with the lack of prospective data are reluctant to change technique. We are~     confident that if we can demonstrate a significant difference in surgical complication rate~     and promote a modification to the IAPE surgical technique then we can significantly reduce~     surgical harm to these frail patients.~   "
27132|NCT02702076|"~     This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of~     continuous apomorphine infusion compared to placebo in PD patients with visual~     hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.~   "
27133|NCT02702063|"~     Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical~     cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output.~     However, its accuracy has been inconsistent. Therefore Martin et al. have compared~     measurements with echocardiographic measurements and propose calibration with left ventricle~     outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This~     study was performed in pregnant women at term. Goal of this study is to validate their~     formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up.~     Secondary aim is to perform a leg raising test and to compare changes in stroke volume~     observed with either EC or TTE.~   "
27134|NCT02702050|"~     The purpose of this study is to investigate the efficacy of mechanical stimulation on~     mastectomy scars in:~      (i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii)~     reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of~     life, in women with breast cancer after mastectomy.~   "
27135|NCT02702037|"~     The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand~     exercise during routine care, in combination with an oral protein-rich supplement, on~     functional status and independence in frail older persons. In this study we will also~     explore the experiences among older persons in the intervention group as wells as among~     staff of promoting the sit-to-stand exercise and nutritional supplement to gain knowledge~     for implementation as a daily routine in nursing homes across Sweden.~      Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a~     daily routine along with an oral protein-rich supplement, will result in improved functional~     status and independence in everyday life activities and thereby enhance health-related~     quality of life in older persons living in nursing homes. The primary outcome measure for~     functional status will be the number of sit-to-stands that the participant is able to~     complete in 30 seconds.~      Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral~     protein-rich supplement on functional and nutritional status, and health-related quality of~     life, and the frequency and incidence of falls, pressure ulcers and incontinence in older~     persons living in nursing homes. Furthermore, the cost effectiveness of the combination of~     the sit to stand exercise and oral protein-rich supplement vs. the control group will also~     be examined.~      Aim II: To describe the older persons' perceptions of daily being offered to conduct the~     sit-to-stand exercise and to drink the nutritional supplement.~      Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the~     nutritional supplement with older persons living in nursing homes.~   "
27136|NCT02702024|"~     Placenta percreta is a life-threatening condition that patients are under risk of massive~     bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean~     hysterectomy is the procedure that is acknowledged worldwide, however, recent studies~     discussing conservative treatment with segmental resections were published. Fetal extraction~     and segmental resection could be performed from same (single uterine incision) or two~     different (double uterine incision) incisions. In this study, the investigators aimed to~     evaluate the effectiveness and the results of double uterine incision.~   "
27137|NCT02702011|"~     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily~     oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive~     therapy to insulin.~   "
27138|NCT02701998|"~     This study involves a randomized controlled trial to test the feasibility, acceptability,~     and efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to~     increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior~     (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack~     (TIA).~   "
27139|NCT02701985|"~     This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group~     study designed to evaluate the effects of RO5459072 treatment on disease activity and~     symptoms of Sjogren's syndrome in adult participants with moderate to severe primary~     Sjogren's syndrome.~   "
27140|NCT02701972|"~     The preclinical and clinical evidence of safety and efficacy with the BACE device (concept~     and feasibility) paved the way for the evaluation of the BACE device in this prospective,~     multi-center, single-arm, self-controlled study for safety and efficacy in the treatment of~     functional MR in a maximum of 60 adult subjects.~      The primary efficacy endpoint will be reduction of MR grade to 1+ or less from the baseline~     MR grade through the 6 month study period. Primary safety endpoint will be freedom from~     major device and surgery-related adverse events for the duration of the 6 month follow up~     period. Patients will be followed up to two years.~   "
27187|NCT02701348|"~     The purpose of this study is to monitor the change in cancer size in women with breast~     cancer on anti-hormone treatment using different types of assessment including ultrasound~     scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how~     this corresponds to the changes in the cancer biology.~   "
27142|NCT02701946|"~     Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic~     surgery. Nevertheless, significant postoperative blood loss and requirement of blood~     transfusion are still problematic. Total blood loss in TKA can be divided into visible and~     invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and~     wound drainage while invisible blood loss (IBL) means residual blood in the knee,~     extravasation into the tissues and loss due to haemolysis.~      In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus~     intraoperative blood loss can be negligible and postoperative drainage is only considered as~     VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their~     results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA.~     Therefore, the true total blood loss was underestimated if not takes IBL into account.~      Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in~     orthopaedic practice. Various techniques of application have been proposed.~      From the previous study, MRJB could make and maintain the anterolateral muscle compartment~     pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause~     the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially~     IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage~     after TKA is still controversy in clinical practice.~   "
27143|NCT02701933|"~     In this study, the investigators examine the effects of low-dose ketamine on different~     oculomotor, perceptual and cognitive functions. They also examine effects on concurrent~     brain activity using blood oxygen level dependent (BOLD) functional magnetic resonance~     imaging (fMRI). A sample of N=25 healthy, male participants is required to complete the~     study. The design is within-subjects, placebo-controlled, double-blind and cross-over. A~     targeted ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine,~     compared to placebo, will lead to changes in task performance and brain activity similar to~     those observed in patients with schizophrenia.~   "
27144|NCT02701920|"~     This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a~     hat with other common forms of heart rate monitoring such as electrocardiography (ECG),~     stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new~     heart rate sensor's reliability and accuracy.~   "
27145|NCT02701907|"~     Adult patients with metastatic or locally advanced solid malignancies (including but not~     limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal~     cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or~     having presented an exceptional and unexpected response to an antineoplastic targeted~     therapy.~   "
27146|NCT02701894|"~     With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve~     diabetes management have been emphasized in the scientific community. Particular attention~     has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty~     acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has~     been suggested by animal and cell studies to play a beneficial role in regulating blood~     glucose levels. However, human studies have been more inconsistent with their findings. The~     focus of this project is to investigate the evidence in the context of ALA and blood glucose~     parameters in participants with type 2 diabetes by conducting a systematic review and~     meta-analysis of randomized controlled trials.~   "
27147|NCT02701881|"~     -  Prospective, randomized, controlled, multi-center study~        -  A total of 220 subjects with long femoropopliteal lesions will be included according to~          inclusion and exclusion criteria.~        -  Patients will be randomized in a 1:1 manner into long stenting group versus short~          stenting group. and treated with Zilver PTX for long femoropopliteal lesions~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.~   "
27148|NCT02701868|"~     Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants~     in the U.S. are fed infant formula. Despite an almost identical energy density between~     infant formula and breast milk, formula fed infants experience greater weight gain in the~     first year of life. The investigators propose that unintentional overfeeding, of nearly one~     additional day of calories per week, due to the over-scooping of powdered formula~     contributes significantly to this phenomenon and potentially to the early development of~     childhood obesity, a significant public health problem.~   "
27149|NCT02701855|"~     This study aims to determine the relationships between retina micro-vascular remodeling and~     cognitive function in hypertensive patients.~      The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and~     60 without MCI).~   "
27150|NCT02701842|"~     The researchers want to find out more about a standalone software application, ImPACT Online~     and how it relates to other commonly used tests of memory, attention and reaction time.~     ImPACT Online is a computer-based neurocognitive test for concussion management. The test~     was designed to help measure the effects of concussion on cognitive processes (for example,~     memory, attention, brain speed) and visual functioning.~   "
27151|NCT02701829|"~     In our past work it was found that many drivers had high blood pressure, and lifestyles that~     led to being overweight and not having cancer screenings performed. The investigators are~     now adding to the Health Fairs' usual program different ways of following up with drivers~     who attend our Health Fairs. The investigators are doing this because they want to find the~     best way to help drivers manage high blood pressure, and reduce cancer risk, by maintaining~     a healthy weight and increasing colorectal cancer screening.~   "
27152|NCT02701816|"~     -  Prospective, single-arm, multi-center registry study~        -  A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and~          exclusion criteria will be included.~        -  Patients will be followed clinically for 12 months after the procedure.~        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to~          participating hospital's protocol will be performed at 12 months.~        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12~          months.~        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)~   "
27153|NCT02701803|"~     In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and~     continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by~     using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device.~     In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing~     it with written patient diaries.~   "
27155|NCT02701764|"~     Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in~     some patients, they can persist. The investigators believe that in some individuals, dry eye~     symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The~     investigators wish to study if a medication, called pregabalin, can protect corneal nerves~     at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6~     months after surgery. This medication has been used in a similar way to reduce the frequency~     of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied~     in LASIK surgery.~   "
27156|NCT02701751|"~     The primary purpose of this study is to examine the effects of chronic exercise training and~     an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g.,~     glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous~     adipose tissue structure and metabolic function in overweight adults.~   "
27157|NCT02701738|"~     The primary purpose of this study is to examine the effects of 1-week of overeating on~     important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile,~     and blood pressure) and factors regulating the structure and metabolic function of fat~     tissue. This study will determine how regular exercise during this overeating period impacts~     these responses.~   "
27158|NCT02701725|"~     The investigators will use the Compensatory Reserve Index (CRI) device to monitor~     hemodynamic status of patients in the hospital. CRI values of patients will be monitored~     during their care in order to verify the compliance of the values to the physiological~     condition. During the protocol investigators will document patients injuries, life-saving~     procedures performed, response to treatment as well progress to systemic inflammatory~     response syndrome (SIRS) and sepsis.~      The indices measured in the study will not be a consideration when handling patients. The~     medical team will not be exposed to metrics measured.~   "
27159|NCT02701712|"~     The aim of this study is to evaluate the technical performance of magnetic-resonance guided~     radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the~     workflow of the clinical team in this facility.~   "
27160|NCT02701699|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using~     a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and~     responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure~     hypoxia may be better and simpler than the approaches used previously. This study will~     assess whether or not PET scans can provide useful information about hypoxia in lung cancer.~      In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to~     measure hypoxia in the patient's tumour. FAZA has already been used in many cancers~     including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA~     PET Scan prior to their first radiotherapy treatment~   "
27161|NCT02701686|"~     The purpose of this study is to test the effectiveness of negotiating self determination to~     reduce cigarette consumption. A single-blinded multi-centre randomized controlled is~     employed.~   "
27162|NCT02701673|"~     The goal of this clinical research study is to find the highest tolerable dose of belinostat~     that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to~     patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell~     lymphoma (DLBCL), you will also receive rituximab. Researchers also want to learn about the~     safety and effectiveness of this combination.~   "
27163|NCT02701660|"~     Electronic dispensers for polypharmacy are used in home care to assist patients with their~     medication management and to improve adherence. Opioid dependent patients with substitution~     therapy often exhibit multiple risk factors for non-adherence. The increase of both the age~     and associated comorbidities in this population demand for innovative solutions to optimize~     medication management. The investigators developed a novel medication supply model with an~     automated electronic medication dispenser to simultaneously assist opioid dependent patients~     with their medication and objectively monitor their adherence. This study aims to~     demonstrate the feasibility of the new supply model.~   "
27164|NCT02701647|"~     The Purpose of this study is to investigate whether the beneficial effect of treadmill~     training on people with Parkinson's disease can be enhanced by repetitive transcranial~     magnetic stimulation (rTMS).~   "
27165|NCT02701634|"~     This study will evaluate the effect of entospletinib on the best overall response rate in~     adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic~     corticosteroids as first-line therapy for cGVHD.~   "
27166|NCT02701621|"~     The aim of this study is to compare the effectiveness of a specific aquatic therapy program~     on balance with a land-based physical-treatment in patients with Parkinson's disease and to~     evaluate the long-term effects in a 6-month follow-up period.~   "
27167|NCT02701608|"~     Infective endocarditis (IE) is a serious infection with a significant burden for patients~     and hospitals (in France, median length of hospital stay = 43 days), partly due to the long~     duration of intravenous (IV) antibacterial treatment recommended by international~     guidelines, between 4 and 6 weeks in most situations.~      A recent survey of practices regarding the management of IE in France showed that a switch~     from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are~     stable after an initial course of IV antibiotic treatment, with or without valvular surgery.~      These practices have not been associated with unfavourable outcome, while significantly~     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and~     patients' discomfort.~      There has been no randomized controlled trial (RCT) in the field of IE over the last 20~     years; current guidelines are mostly based on expert advice, in vitro studies, animal~     experiments, or clinical studies performed before the 90's.~      The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in~     the field of IE.~      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such~     as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE~     when orally administrated after an IV period of induction.~      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this~     strategy for multisusceptible staphylococci with a benefit regarding costs.~      The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch~     strategy, making it a comparative effectiveness trial that should be able to feed the next~     revision of IE international guidelines and to change practices in IE management.~   "
27168|NCT02701595|"~     Infective endocarditis (IE) is a serious infection with a significant burden for patients~     and hospitals (in France, median length of hospital stay = 43 days), partly due to the long~     duration of intravenous (IV) antibacterial treatment recommended by international~     guidelines, between 4 and 6 weeks in most situations.~      A recent survey of practices regarding the management of IE in France showed that a switch~     from IV to oral antibiotics is feasible, when patients with left-sided~     Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment,~     with or without valvular surgery.~      These practices have not been associated with unfavourable outcome, while significantly~     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and~     patients' discomfort.~      There has been no randomized controlled trial (RCT) in the field of IE over the last 20~     years; current guidelines are mostly based on expert advice, in vitro studies, animal~     experiments, or clinical studies performed before the 90's.~      The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in~     the field of IE.~      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such~     as amoxicillin allow a high level of efficacy in the treatment of IE when orally~     administrated after an IV period of induction.~      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this~     strategy for streptococci, and enterococci IE with a benefit regarding costs.~      The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch~     strategy, making it a comparative effectiveness trial that should be able to feed the next~     revision of IE international guidelines and to change practices in IE management.~   "
27169|NCT02701582|"~     This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000~     system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor~     resection complicated by cerebral edema, or complex spinal surgery including multi-level~     scoliosis correction, is a more effective way of monitoring fluid.~   "
27170|NCT02701569|"~     The purpose of this study was to investigate the effect of rebound exercise (mini trampoline~     jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.~   "
27171|NCT02701556|"~     The objective of this study is to evaluate the safety and effectiveness of NNR06~     Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE~     Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual~     contact lens wearers to bilaterally clean and disinfect their contact lenses for~     approximately three months.~   "
27172|NCT02701543|"~     To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic~     or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal~     Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.~   "
27173|NCT02701530|"~     The aim of this trial is to develop a new tailored smoking cessation program for smokers~     with low education. Smokers are involved in design of the intervention. The effect of the~     intervention is then tested in a randomised controlled trial. Half of workplaces will be~     offered the intervention and the other half will be control group, not receiving any offer.~   "
27174|NCT02701517|"~     The primary aim of the study was to compare the efficacy of the procedure in terms of~     event-free survival between patients receiving cyclosporine (CsA) plus either alemtuzumab~     (CAMPATH-1H ) or methotrexate (MTX) after matched related donor allo-reduced intensity~     conditioning. Secondary aims were: 1. To compare the incidence of infections and~     transplant-related mortality between the two arms; 2. to compare the incidence of acute and~     chronic GVHD 3. to evaluate hematologic and immunologic reconstitution and evolution of~     chimerism and residual disease.~      Patients were randomly assigned to received cyclosporine plus alemtuzumab or cyclosporine~     plus MTX and were stratified according to diagnosis: Chronic lymphocytic leukemia or Low~     grade- non-Hodgkin's lymphoma.~      All patients received the same reduced-intensity conditioning (RIC) scheme based on~     fludarabine 150mg/m2 (30 mg/m2/day everyday from -8 to -4) plus melphalan 140mg/m2 (70~     mg/m2/day everyday from -3 to -2). Regarding the GVHD prophylaxis, patients in group 1~     (n=17) received CsA 1 mg/kg intravenously starting on day -7 and 2/mg/Kg from day -1 plus~     alemtuzumab administered at a dose of 20 mg IV on -8 to -4 whereas in group 2 (n=23) pts~     received CsA at same doses as group 1 plus MTX given at a dose of 15 mg/m2 intravenously on~     days 1 and 10 mg/m2 on days 3, 6 and 11, followed by folinic acid rescue (15 mg in +1 and 10~     mg in +3, +6 and +11 intravenously every 6 hours for 4 doses starting 24 hours after each~     dose of MTX).~      Acute and chronic GVHD were similarly graded by established criteria [20, 21]. In patients~     receiving alemtuzumab, CsA was suspended by day +130. They also received donor lymphocyte~     infusion (DLI) at a dose of 1 x 107 cluster of differentiation 3 / kg on day +180 in case of~     active disease, persistence of minimal residual disease detected by flow cytometry or mixed~     chimerism and no GVHD. In case mixed chimerism, donor lymphocyte infusion was performed if~     patient hematopoiesis progressively increased. In patients receiving CsA + MTX, CsA was~     suspended by day +180. These patients received DLI only in situations specified above.~      The statistical analysis has been designed to identify a 20% difference in terms of~     disease-free survival (based on the increased incidence of relapse in patients receiving~     T-cell depletion).~   "
27175|NCT02701504|"~     Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous~     studies suggested sleep apnea was associated with coronary plaque burden and future adverse~     cardiovascular events. Sleep apnea is also associated with a high incidence of atrial~     fibrillation in patients undergoing coronary artery bypass grafting. Yet, previous reports~     used Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire to diagnose sleep~     apnea. However, these screening questionnaires are not as accurate as a proper sleep study.~     In the SABOT study, the investigators used the portable sleep device to diagnose sleep~     apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after~     coronary artery bypass surgery.~   "
27176|NCT02701491|"~     The acute gastroenteritis is a very common problem in children. The frequency and duration~     of this condition involves a high discomfort for the child and his family, and significant~     costs, in connection with the purchase of therapeutic aids, medical visits, days of work~     lost by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of~     the cases of acute gastroenteritis and is very often the cause of failure of oral~     rehydration use and hospitalization.~      To limit vomiting and facilitate oral rehydration have been proposed several pharmacological~     strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and~     side effects (ondansetron and metoclopramide) and therefore contraindicated in patients of~     pediatric age.~      The administration of some medicinal herbs is able to induce an effective anti-emetic power.~     Among the various types of plants studied, the rhizome of Zingiber officinale, commonly~     known as ginger is used as an antiemetic in various traditional systems of medicine for over~     2000 years. There are several scientific evidence on the beneficial properties of ginger,~     including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also~     demonstrated that ginger is effective in resolving the post-operative nausea and vomiting~     and in pregnant. A recent meta-analysis has confirmed that ginger is effective in~     non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.~      To date there are several formulations of the ginger on the market in Italy, and their use~     is fairly widespread in children for the treatment of vomiting by acute gastroenteritis in~     the absence of clinical evidence of efficacy.~      The purpose of the proposed study is to demonstrate the effectiveness of treatment with~     ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.~   "
27328|NCT02699515|"~     The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study~     consists of dose-escalation part and an expansion part in subjects with metastatic or~     locally advanced solid tumors, for which no standard effective therapy exists or a standard~     therapy has failed.~   "
27177|NCT02701478|"~     N2O has been used during general anesthesia (GA) for more than 100 years. It is known to~     have anesthetic agents sparing effect. But small is know on his real analgesic effect during~     GA. So far, the only way to monitor pain during GA was based on vital signs that are not~     specific and not sensitive. Few devices tried to evaluated pain under GA during the last 2~     decades. More recently, better devices were proposed such as the Physiodoloris device and~     the PMD200 device. The first offers an index called ANI based on heart rate variability~     (HRV) assessment. The second offers the NoL index based on the analysis of 5 parameters. The~     aim of the present study is to evaluate quantitatively the analgesic index of N2O during GA~     using the two indices ANI and NoL.~   "
27178|NCT02701465|"~     The purpose of this randomized clinical trial is two-fold. Firstly to see if patients~     suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in~     their shoulder, and secondly to investigate how changes in this blood flow are related to~     pain experience and shoulder function.~   "
27179|NCT02701452|"~     In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high~     risk populations 9 days after oocyte triggering with hCG. Many studies report no or a~     markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However,~     criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It~     is well known that OHSS is associated with hypercoagulability. However, no study after~     triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high~     circulating estradiol levels.~      Study design, size, duration: In a French academic reproductive medicine centre, a~     systematic prospective observational follow-up of all patients triggered by GnRH agonist for~     excessive follicular response will be conducted. Participants/materials, setting, methods:~     All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000~     pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by~     GnRH agonist. No luteal phase support and a freeze-all strategy will be performed. On the~     day of oocyte retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability~     will be systematically assessed. Haemostasis data will be compared to the initial status of~     each patient.~   "
27180|NCT02701439|"~     This study is investigating a better method to see if someone has tuberculosis (TB) as~     compared to the method that is being used now.~   "
27181|NCT02701426|"~     Background:~      Obesity increasingly affects young women and contributes to increased maternal, fetal and~     neonatal complications. Maternal obesity contributes to the subsequent development of~     childhood obesity not only through social and environmental mechanisms but also through~     biological processes referring to the original concept of the developmental health and~     disease. Data suggest that management during pregnancy through nutrition counseling and~     adequate physical activity will help to break the familial vicious circle of obesity. To~     help program to be effective it is important to understand the factors that modulate~     participation. However, few studies have been conducted to assess the determinants that~     influence participation.~      Goal:~      The main objective is to analyze 15 factors that influence participation in a program~     combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25~     kg/m2. Secondary objectives are :~        -  to identify the data that influence adherence and to show that assiduous women will~          have a better control of weight gain and a reduction of maternal and fetal~          complications.~        -  to understand the biological mechanisms involved~      Strategy and method:~      A prospective research evaluating the participation in an educational program, including~     nutritional support and adequate physical activity, will be offered to overweight and obese~     pregnant women. The program will last 12 weeks, and will include three workshops on diet of~     the pregnant and lactating women, and the young child. Physical activity sessions will be~     offered once a week. Fifteen independent variables likely to influence participation will be~     analyzed. The association between participation and the risk of maternal and fetal pregnancy~     complications related to obesity will be analysed. Meanwhile, more fundamental research will~     be considered to determine of the biological factors involved.~   "
27182|NCT02701413|"~     For too many women, childbirth results in devastating consequences: involuntary loss of~     feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with~     severe tears during childbirth may develop these problems. These new mothers avoid leaving~     home in order to stay close to a toilet, wear protective pads every day, and avoid~     activities they previously enjoyed such as exercise and sexual intercourse. It is not~     surprising that many of these women suffer from postpartum depression, and bonding with~     their newborns is compromised.~      Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during~     childbirth. Many researchers have focused on what can be done to prevent these injuries;~     however, few have investigated how to help the countless women who have already suffered~     from these injuries to the nerves and muscles. In other fields such as orthopedics and~     neurology, research shows that electrical stimulation can provoke nerve regeneration after~     injury. Applying this technology to women who have recently suffered from nerve injury~     during childbirth could have profound and life-changing effects. Investigators hypothesize~     that electrical stimulation immediately postpartum will markedly help pelvic nerves~     regenerate, minimizing rates of fecal and urinary incontinence for this vulnerable~     population of new mothers.~   "
27183|NCT02701400|"~     This randomized clinical trial studies how well tremelimumab and durvalumab with or without~     radiation therapy works in treating patients with small cell lung cancer that has returned~     after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab,~     may limit the ability of tumor cells to grow and spread by enhancing immune function.~     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving~     tremelimumab and durvalumab together with radiation therapy may lead to improved clinical~     benefit.~   "
27184|NCT02701387|"~     The purpose of this study is to determine whether implant thread design impacts bone~     remodeling and/or dental implant stability in the early healing period.~      The population of this study will consist of a group of subjects who are interested in~     replacing two or more missing teeth with dental implants. All implant sites will be healed~     and not require bone augmentation for the placement of a standard 4 mm diameter implant.~     Subjects first will undergo a brief screening exam. If accepted, comprehensive oral exam~     will be completed. Subsequently, enrolled subjects will be scheduled for dental surgery to~     place the implant(s). Subjects will return weekly for the first 8 weeks after placement for~     a brief post-operative appointment in order to conduct measurements for the study.~   "
27185|NCT02701374|"~     In Post-Herpetic Neuralgia(PHN) patients:~        -  To conduct an explorative investigation of the efficacy and safety of repeated oral~          doses of TRK-700 via a randomized double blind comparative study~        -  To measure the plasma concentration of TRK-700 and its metabolites~   "
27186|NCT02701361|"~     Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of~     depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the~     investigators will test the impact of mindfulness to address this distress.~   "
27188|NCT02701335|"~     Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central~     sensitization of pain can be one of the causes: this hypothesis opens avenues for research~     in the modulation of pain pathways. The peripherally directed therapies may modulate pain~     perception bilaterally. This hypothesis opens avenues for future research in the modulation~     of pain pathways, perhaps offering targets to optimize peripheral manual and physical~     therapies for pain management in hand OA.~      Several studies have reported the outcomes of multimodal approach to central sensitization~     evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal~     (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural~     structures through positioning and movement of multiple joints. Recent technologies have~     facilitated the use of robots as tools to assist patients in the rehabilitation process thus~     maximizing patient outcomes. These robotic tools assist the patient with carrying out~     exercise protocols, optimal for the activity of the control group.~   "
27189|NCT02701322|"~     The purpose of this study is to determine whether a participation of a medical clown in~     videofluoroscopic examination of pediatric speech disorder such as velopharyngeal~     inadequacy, improves the collaboration of the pediatric patient, the patient's and the~     caregivers subjective experience, and the quality of the examination (shorter exposure to~     radiation, shorter time at the radiology suite, more accurate parameters retrieved from the~     imaging results).~   "
27190|NCT02701309|"~     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence~     non-invasively from the intact oral mucosa in children. The prototype device has shown high~     sensitivity and specificity in women after delivery for iron deficiency. Children are at~     increased risk for iron deficiency and prevention methods are not established jet. Zinc~     protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than~     other established parameters. The prototype device is used to measure the erythrocyte zinc~     protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are~     at increased risk for iron deficiency as they are growing rapidly and iron deficiency in~     this age may affect the neurodevelopment and immune system adversely. It is proposed that~     these effects cannot be rectified by iron supplementation in later years. The results from~     the non-invasive measurements are compared to reference measurements of the erythrocyte zinc~     protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other~     indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin,~     transferrin saturation and soluble transferrin receptor.~   "
27191|NCT02701296|"~     To assess pain control after total knee replacement surgery using two different nerve block~     techniques. The 2 methods are:~        1. Continuous femoral nerve block with ultrasound guided posterior capsular injection~        2. Continuous femoral nerve block with ultrasound selective tibial nerve block.~   "
27192|NCT02701283|"~     The study objective is to demonstrate that the safety and effectiveness of the Medtronic~     TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is~     noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low~     predicted risk of operative mortality for SAVR.~   "
27193|NCT02701270|"~     The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products~     1 and 2 are digested using glycaemic and insulinaemic response as markers.~   "
27194|NCT02701257|"~     This study will compare two different models of a wearable bionic pancreas device (the~     iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1~     diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then~     give insulin and/or glucagon automatically to regulate the blood glucose (BG). The iPhone~     bionic pancreas has been used in earlier studies, during which volunteers used the system~     for up to 11 days at a time while living their normal lives at home and work. The iLet~     bionic pancreas has never been tested in humans. In this new study, volunteers will~     participate in a training visit to learn how both devices work. They will then use the~     iPhone-based BP for 1 day and the iLet BP for 1 day in random order using Lilly glucagon.~     They will then use the iLet BP for one additional day using Xeris Xerisol glucagon (a stable~     formulation of human glucagon).~   "
27195|NCT02701244|"~     For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a~     common treatment option. Radiation treatment is typically delivered to the whole breast,~     five times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer~     cells that may have been left over following the surgery but causes skin burns. Many studies~     have demonstrated that radiation to the whole breast is not necessary, that it can be~     delivered to a portion of the breast where the cancer is more likely to recur.~      A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of~     radioactive seeds has been developed to deliver the radiation to a portion of the breast.~     The procedure is performed on an out-patient basis under local anesthesia and light~     sedation. Because the radioactive seeds are permanently implanted in the breast, the patient~     is able to live a normal life while the seeds deliver the prescribed radiation to the~     breast.~      Previous studies on PBSI demonstrate that it is a safe and effective alternative form of~     radiation for appropriately selected patients after lumpectomy. However, those results have~     been obtained mainly from a single institution, with only 4 patients treated in another~     center. Further research is still needed to evaluate its safety in a multi-center setting.~     The purpose of this study is to ensure the appropriate training of clinicians who will be~     performing this procedure and to capture long term outcomes and rare complications if any.~   "
27196|NCT02701231|"~     The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy~     System is effective and safe in the treatment of advanced lung cancer.~   "
27197|NCT02701218|"~     Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be~     randomized to treat with single or multiple cycles of canalith repositioning procedure.The~     treatment outcomes will be assessed at 7th and 28th days.~   "
27219|NCT02700932|"~     This is an open-label, multi-center study. Subjects in this study will receive up to eight~     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064~     nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects~     will return for one follow‐up (FU) visit at the clinic at 8 weeks following the last~     treatment.~      Methodology described in the protocol to evaluate efficacy and safety of treatments will be~     carried out at each visit at the clinic~   "
27198|NCT02701205|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in~     the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the~     different maintaining treatment programme in Moderate to Severe plaque psoriasis by~     Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in~     Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque~     psoriasis patients,and at the first stage they will be randomized divided into three group:~     full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind~     stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of~     Qiangke® for additional 12 weeks.~   "
27199|NCT02701192|"~     The purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in~     and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx~     is removed) and to report on the rate of complications of the procedure. The study will also~     aim to find pre-operative clinical predictors of good outcomes after coccygectomy. The~     investigators hypothesize that coccygectomy will not improve scores on the Short Form-36~     (SF-36), Oswestry Disability Scale (ODI), tolerable sitting time, or Visual Analog Pain~     Scale (VAS). Also, the investigators hypothesize that there are no independent variables~     associated with improved outcomes.~   "
27200|NCT02701179|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of~     various bronchopulmonary diseases. Most patients tolerate the procedure well although cough~     is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy~     would be significantly improved with control of cough. Use of sedation during bronchoscopy~     has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy~     is routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of lower concentrations (1%) versus a higher (2%) during~     bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as~     effective as 2% lignocaine for airway anaesthesia during flexible bronchoscopy.~   "
27201|NCT02701166|"~     Randomized double blind placebo controlled trial to evaluate the antipruritic effect of~     bezafibrate in patients with moderate to severe cholestatic itch.~   "
27202|NCT02701153|"~     This phase II trial studies the side effects of hypofractionated radiation therapy in~     treating patients with soft tissue sarcomas that have come back before surgery.~     Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter~     period of time and may kill more tumor cells and have fewer side effects.~   "
27203|NCT02701140|"~     The aim of this study is to assess the pleiotropic effects of ticagrelor that could~     represent possible mechanisms for its beneficial effects on cardiovascular mortality. We~     will test three different hypotheses:~        1. Ticagrelor may increase ischemic preconditioning as compared to clopidogrel in patients~          with stable coronary disease, showing multivessel coronary artery disease and~          undergoing staged PCI.~        2. Ticagrelor may improve microvascular perfusion in the myocardium of patients with~          multivessel coronary artery disease undergoing staged PCI.~        3. Ticagrelor may exert positive effects enhancing the paracrine modulation, migration,~          homing and survival of hBMDSC, with a potential impact on the microvascular dysfunction~          and on the protective response to ischemia (cellular preconditioning).~   "
27204|NCT02701127|"~     This is a single center, randomized, single-blind, placebo-controlled study to evaluate the~     safety and biochemical effects of niacinamide on metabolic parameters of the kidney in~     patients undergoing cardiac surgery.~   "
27205|NCT02701114|"~     This study is designed to evaluate pain control of continuous adductor canal blocks placed~     proximally versus distally within the canal. The investigators hypothesize that there will~     be similar pain control between both groups.~   "
27206|NCT02701101|"~     This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an~     adjunct to clinical judgment for detection of early pressure ulcers in patients before skin~     assessments.~   "
27207|NCT02701088|"~     Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is~     increasing. As epidermoid ACC (95% of ACC) are particularly sensitive to radio and~     chemotherapy, concomitant radio-chemotherapy is the standard treatment of locally advanced~     ACC, with proven efficacy on locoregional control, anal sphincter preservation,~     progression-free survival and complete response rate higher than 80%.~      Nevertheless, conventional radiotherapy frequently induces significant non-haematological~     toxicities requiring treatment interruptions. Thus, treatment usually includes a~     chemotherapy (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a~     planned 1-week (or more) interruption and a boost, for a total 54-60 Gy radiation dose over~     9 weeks.~      Considering the numerous anatomic pelvic structures, ACC has become a localisation of~     interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.~      However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose~     escalade did not show its interest: 60 Grays remains the standard.~      Assuming the deleterious effect of increased overall treatment time on local control and~     survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the~     benefit of no irradiation break on ACC tumour control is of interest.~      IMRT offers the possibility to deliver different doses to different target volumes~     simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated~     boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results~     were observed with moderate doses and schedules delivering higher doses with short~     interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.~   "
27208|NCT02701075|"~     The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that~     interferes with pain signal transmission by using nerve fibers as a passive means to convey~     a message of normality (sans pain) to the central nervous system. While preliminary research~     has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and~     failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain~     secondary to traumatic musculoskeletal injuries like those experienced in combat has not~     been investigated. The purpose of this prospective, double-blind, randomized controlled,~     study is to determine if the MC5-A ST is efficacious in altering the biological,~     psychological, and social components of the chronic neuropathic pain experience in military~     Service Members (SMs) with traumatic musculoskeletal extremity injuries.~   "
27209|NCT02701062|"~     Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 3 and~     HASBLED of => 3 and will undergo a valve or CABG (structural heart) procedure with direct~     visual access to the LAA will be eligible to participate based upon the inclusion and~     exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 20~     sites and will be randomized 2:1 (2 with AtriClip to 1 anticoagulation therapy and without~     AtriClip). Subjects who do not develop Post-operative Atrial Fibrillation (POAF) will be~     followed for 30 days for safety, subjects who develop POAF will be followed for 365 days~     post index procedure.~   "
27210|NCT02701049|"~     This trial is the final phase of a three phase PCORI-funded study to develop and test~     patient-centered approaches to collect sexual orientation and gender identity (SO/GI)~     information in the ED. From the results of Phase 1 qualitative interviews and national~     quantitative survey and Phase 2 Delphi rounds with the Stakeholder Advisory Board, we have~     determined two methods of collection favored by patients and providers to implement in the~     trial. The first method, nurse verbal collection, is in alignment with Partners recommended~     clinical practice and is therefore a quality improvement (QI) evaluation. The second method,~     non-verbal registrar form collection with nurse verbal confirmation, is a research~     intervention to evaluate and compare a new patient-centered approach to SO/GI collection. To~     compare the patient-centeredness of the two different approaches, satisfaction surveys will~     be administered to ED patients and staff members involved in collection.~      In summary, the study design (1) evaluates recommended current practice (QI), (2) evaluates~     a quality improvement project to increase recommended current practice, and (3) evaluates a~     new method of collecting SO/GI (research intervention).~   "
27211|NCT02701036|"~     The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of~     cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to~     determine the rate of disease progression in both groups including determination of the~     factors that predict the development of MSA-C vs. SAOA, and at which time after onset of~     ataxia, a reliable distinction between both disorders is possible.~      The planned study will also allow to collect blood samples and other biomaterials from~     patients with sporadic ataxia, which will be useful for future genetic and biomarker~     studies.~   "
27212|NCT02701023|"~     The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the~     treatment of UTUC in a human subject with low-grade UTUC which is endoscopically~     unresectable or rapidly recurring, and in whom nephrectomy would likely result in the need~     for permanent hemodialysis. The study drug would be obtained under the single patient access~     program approved by the FDA. The patient would then undergo instillation of MitoGel into the~     affected kidney. The catheter would be left indwelling in the ureter and would be~     externalized. The ureteral and urethral catheters would remain indwelling for the duration~     of the 6 treatments, which would occur twice weekly for 3 weeks or once weekly for 6 weeks.~     Following the final instillation, the catheters would be removed. The patient would then~     undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel.~     The total duration of study would be 3 months. The total number of study patients is 1.~   "
27213|NCT02701010|"~     Researchers aimed to identify the effectiveness of three methods of patient education for~     behavioral therapy (BT), including verbal instructions combined with a leaflet on a~     structured training program of BT, only verbal instructions on a structured training and~     only a leaflet on a structured BT training. Therefore, a randomized controlled trial was~     designed to compare effectiveness of those methods of patient education in BT based on the~     two validated patient- reported outcome measures (PROMs) for women with overactive bladder.~      Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal,~     which does not threaten life and not require to be treated immediately. It is necessary to~     raise the awareness of iOAB on women. The education and consultancy role of continence~     nurses is important in the treatment and care of urinary incontinence (UI) associated with~     iOAB. In the study, it was seen that the training to be provided to patients is helpful~     regardless of the teaching method used. Also it was found that the method of verbal~     instructions in the form of a structured training plus giving a leaflet to patient is the~     most effective method of BT for female iOAB.~   "
27214|NCT02700997|"~     This study seeks to gain a more thorough understanding of the postoperative location of the~     sutures placed during uterosacral ligament suspension. Characterization of the surrounding~     anatomy in a living model will enhance surgical technique by delineating safer suture~     locations and decrease the incidence of morbid complications for patients.~   "
27215|NCT02700984|"~     This is an observational study involving patients who completed the COMPASS Trial, in which~     the CyPass Micro-Stent was evaluated through 2 years postoperatively . In the COMPASS-XT~     study, clinical data will be collected on participating subjects for an additional 3 years.~   "
27216|NCT02700971|"~     This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines~     the molecular and histopathological features of biopsies, plus clinical and laboratory~     parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized~     to phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA~     signature.~   "
27217|NCT02700958|"~     Contrast-induced nephropathy (CIN) has remained significant and severe complication of~     angiographic procedures despite the increasing use of preventative methods. It has been~     associated with prolonged hospital stay, high morality and the need for dialysis. Since~     classically used creatinine for diagnosing of CIN does not reflect the degree of tubular~     injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers~     and preventative methods are needed. Remote ischemic preconditioning is a non-invasive and~     safe method which in some studies has been reported to protect against contrast-induced~     nephropathy. The purpose of this study is to evaluate the effect of remote ischemic~     preconditioning (RIPC) (1) as an additional method to standard treatment to prevent~     subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect~     on functional properties of arterial wall, organ damage biomarkers and low molecular weight~     metabolites.~   "
27218|NCT02700945|"~     The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF)~     through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™~     Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC)~     medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known~     origin.~   "
27220|NCT02700919|"~     The purpose of this study is to compare the efficacy and safety of BCT197 when added on to~     standard of care in adult subjects with acute respiratory exacerbations of chronic~     obstructive pulmonary disease requiring hospitalization. Additionally, the study will~     characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the~     study will be 26 weeks. Subjects will receive study treatment administration over a period~     of 5 days after randomization. It is expected that approximately 255 subjects will complete~     the study and follow-up.~   "
27221|NCT02700906|"~     The investigators hypothesized that lidocain injection is as effective as corticosteroid~     injection in management of tennis elbow, and if so, it may replace corticosteroid injection~     in the management of tennis elbow.~   "
27222|NCT02700893|"~     Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier:~     NCT01490580) which is a multicenter double blind randomized controlled trial comparing~     atropine+propofol vs atropine+atracurium+sufentanil as a premedication prior to~     endotracheal intubation of the neonate.~      Primary outcome:~        -  Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before~          premedication).~        -  Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction)~          during premedication, calculated from rScO2 and pulse oximetry with the formula~          FTOE=SaO2 - rScO2/SaO2 .~      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil does not~     increase the frequency of cerebral hypoxemia.~   "
27223|NCT02700880|"~     The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure~     (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed~     ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to~     prospectively document the clinical course of high-risk cardiac patients with heart failure~     and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such~     as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator~     (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart~     transplantation, and to assess the benefit of WCD in heart failure patients with ischemic~     cardiomyopathy.~   "
27224|NCT02700867|"~     The investigators sought to compare the intraosseous access success rates of the proximal~     tibia and the proximal humerus using new Intraosseous access device NIO in an adult~     cadaver model during simulated resuscitation.~   "
27225|NCT02700854|"~     This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of~     low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled,~     mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that~     hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is~     deleterious to the injured brain and can be safely avoided with low concentration CO2~     inhalation.~   "
27226|NCT02700841|"~     This pilot, randomized phase II trial studies how well depleted immune suppressor stem cell~     transplant works compared to standard stem cell transplant in enhancing immune response to~     vaccines in patients with multiple myeloma (MM). Chemotherapy and the patient's own stem~     cells are effective in treating MM, however there is a risk of disease returning due to poor~     recovery of the immune system as shown to poor response to vaccines to prevent infections.~     Before chemotherapy, patients' stem cells are collected and certain immune cells called~     suppressor cells are removed from the stem cells. Patients then receive chemotherapy to kill~     cancer cells and after that the immune depleted stem cells are returned to them to replace~     the blood-forming cells that were destroyed by chemotherapy. Giving depleted immune~     suppressor stem cells transplant to patients with MM may result in a more robust immune~     response to vaccines after transplant and may prevent MM from returning. It is not yet known~     whether depleted immune suppressor stem cell transplant is more effective than standard stem~     cell transplant in enhancing immune response to vaccines in patients with multiple myeloma.~   "
27227|NCT02700828|"~     This is a prospective, randomized, double-blind, placebo controlled, single center study to~     compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia~     treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms~     (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed.~      The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency~     that may contribute to hypotension and lower efficacy of inotropic therapy in this patient~     population. Thus, the investigators are planning to measure initial serum cortisol levels~     and investigate the cardiovascular effects of low dose hydrocortisone supplementation~     besides conventional inotropic therapy in a placebo-controlled fashion.~   "
27228|NCT02700815|"~     This randomised, controlled multi-centre parallel group trial will assess the efficacy and~     tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in~     comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of~     acute back pain or neck pain~   "
27229|NCT02700802|"~     The Feed1st proposed program of research will promote health of informal caregivers with a~     hospitalized child by testing a self-management intervention that addresses the widely~     overlooked problem of caregiver hunger. As many as 54% of parents and other informal~     caregivers of hospitalized children struggle with insufficient food to nourish themselves~     and their family during and after a hospital stay. Hunger impairs caregiver physical and~     mental health by depleting energy for self-care, emotional self-regulation, and supportive~     interactions with the child, the family, and the formal caregiver team. The long-term~     objective of the Feed1st program is to sustainingly alleviate unnecessary suffering due to~     hunger among families with hospitalized children. Established in partnership with nursing~     and chaplaincy leadership at our children's hospital and the Greater Chicago Food~     Depository, the Feed1st program currently operates self-serve food pantries on four~     inpatient units and the emergency department in our children's hospital on Chicago's South~     Side. Since 2010, Feed1st has provided nearly 8500 pounds of food to at least 4,000~     individuals and 1500 households via the self-serve food pantries in the children's hospital.~     Over this same period, our team has also created a system for efficiently connecting~     families to community-based resources for hunger and other basic needs. This system,~     CommunityRx, integrates with our electronic medical record system and connects caregivers to~     a community health information specialist for navigation assistance. Leveraging both Feed1st~     and CommunityRx, we are using a randomized controlled trial, determine the health and health~     care impacts of a self-management intervention versus usual care to reduce informal~     caregiver hunger during and after a child's hospitalization. Findings from this study will~     be used to create a sustainable solution to the root cause problem of hunger among informal~     caregivers of a hospitalized child and will advance sensor-based methods for studying~     informal caregiver self-management behaviors, particularly in intimate settings.~   "
27230|NCT02700789|"~     Study to determine the diagnostic accuracy of the double decidual sac sign to predict an~     intrauterine pregnancy prior to ultrasonographic visualisation of embryonic contents using~     modern ultrasound technology.~   "
27231|NCT02700776|"~     The purpose of this study is find out if a protein level in the blood (called PC Cell~     Derived Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography~     screening, can help detect breast cancer better than mammography screening alone. Earlier~     research has shown that a certain glycoprotein 88 (GP88) is higher in women with breast~     cancer.~      In this study, investigators will measure the level of GP88 in the blood of healthy women~     who are having mammography screening for breast cancer. The investigator plans to correlate~     the results of the mammogram with the GP-88 level.~   "
27232|NCT02700763|"~     In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients~     in this study are diagnosed with advanced melanoma with evidence of brain metastases and are~     eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients~     will undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and~     kinetics in brain metastases. In addition, a static total body PET scan will be performed to~     visualize whole body distribution and tracer uptake.~   "
27233|NCT02700750|"~     The investigators will enroll and scan normal eyes of healthy individuals using the~     Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest~     quality and 40 the best possible one. Each of the participants will be scanned numerous~     times using this noninvasive imaging tool, while trying to get as many scans as possible of~     different quality. The differences in the parameters between the scans will then be recoded.~      Collected data will include age, sex, subjects' refractive status, visual acuity, full slit~     lamp exam and the participants' OCT characteristics and measurements.~   "
27234|NCT02700737|"~     To answer the research question: Would image-based modelling result in different clinical~     decisions as compared to clinical practice guidelines?, we will conduct a randomized~     controlled experiment in which we will compare the hypothetical decisions made by~     interventional cardiologists who are presented with imaging parameters currently recommended~     by clinical practice guidelines vs. hypothetical decisions made by interventional~     cardiologists receiving an expanded list of parameters, including simulation modelling.~   "
27235|NCT02700724|"~     This trial is a randomized, multi-center, non-inferiority study comparing observation versus~     immediate surgery for low grade, noninvasive bladder cancer.~   "
27236|NCT02700711|"~     This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine~     (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and~     urine drug screens.~   "
27237|NCT02700698|"~     The main goal of this project is to determine whether mitochondrial function in circulating~     cells is related to that measured in the muscle fibers of the same subjects.~   "
27238|NCT02700685|"~     This double blind, randomised controlled trial examines the effect of a commercially~     available nutritional supplement on behaviour of ADHD patients, as well as on their physical~     and psychiatric co-morbidities, and level of oxidative stress and immune activity, as~     compared to placebo and standard pharmaceutical treatment for ADHD.~   "
27239|NCT02700672|"~     The study analyses if cognition and gait speed can predict falls in a community-dwelling~     people and ambulant long term care residents~   "
27240|NCT02700659|"~     The aim of this trial is to determine the performance characteristics of the Cxbladder test~     for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history~     of urinary tract UC, who have been treated according to standard practice and are undergoing~     routine investigative cystoscopy.~      The gold standard for determination of clinical truth is cystoscopy, plus any follow up~     investigations relating to the current visit.~   "
27241|NCT02700646|"~     The purpose of this study is to learn more about developmental behaviors and to examine~     changes in developmental progress related to motor activities among a group of infants who~     received open heart surgery within the first three months of life.~   "
27242|NCT02700633|"~     Pacemaker requirement in the immediate post procedure phase following TAVI is approximately~     20% depending on device type and patient characteristics. There is a signal from recent~     studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60~     days. This study aims to address whether there is a mortality advantage to having a~     pacemaker in the short term~   "
27243|NCT02700620|"~     Background: Previous studies on Internet-based treatment with eating disorders have shown~     promising results.~      Objective: The first aim of this study was to investigate the effects of a tailored~     therapist guided internet-based treatment for individuals with eating disorders. The second~     aim was to examine the role of knowledge acquisition.~      Method: 138 participants were recruited. Screening consisted of online questionnaires~     followed by a telephone interview. A total of 92 participants were included after a~     semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or~     to a control condition (n=46). Treatment consisted of individually prescribed cognitive~     behaviour therapy text modules in conjunction with online therapist guidance. The control~     group consisted of a waitlist who later received treatment.~   "
27244|NCT02700607|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing interventional cerebral aneurysm~     coiling procedure are enrolled in this prospective study and randomly allocated into one of~     two groups: Group-C (n=10) and Group-HES (n=10).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-20 according to their order of interview and recruitment. Investigators will~     prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20~     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes~     with cards will be conveyed to and kept in pharmacy department.~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will~     be determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 20th patient's discharge and data~     acquisition~   "
27329|NCT02699502|"~     Metabolic therapy in patients with osteoporosis after hip fracture by cooperation~     orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching~     the follow-up clinic~   "
27245|NCT02700594|"~     Patients with painful knee conditions often present with hip muscle weakness. This weakness~     can lead to, and perpetuate, knee problems. Diminished strength causes movement impairments~     that can lead to pathology, functional limitations and disablement. In some cases, this hip~     muscle weakness is not caused by simple disuse and muscle shrinkage (atrophy). Hip weakness~     may be caused by an inhibitory mechanism that limits the force output of a muscle. The~     inhibition is reflexive and is in response to pain or joint dysfunction. Joint~     mobilization/manipulation can quickly reduce pain and improve joint function, possibly~     decreasing inhibition and increasing strength. Joint mobilization/manipulation may~     facilitate strength recovery. By restoring strength sooner, the patient may avoid the~     deleterious effects of prolonged muscle weakness and achieve quicker or better outcomes.~   "
27246|NCT02700581|"~     The purpose of this study is to determine the difference in the impact of moderate positive~     end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac~     surgery: conventional versus protective ventilation strategy The possible changes in forward~     and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in~     conventional and protective ventilation strategies are analyzed by using intraoperative~     transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .~   "
27247|NCT02700568|"~     Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in~     metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had~     progressed on sunitinib or pazopanib in the first-line setting.~   "
27248|NCT02700555|"~     A prospective, single center, cohort study for surveillance of metabolic parameters in~     patients who will receive chemotherapy after surgical resection of colorectal cancer~   "
27249|NCT02700542|"~     The New York City Department of Health and Mental Hygiene and Montefiore Medical Center,~     with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on~     a study to evaluate the feasibility, health outcomes and return-on-investment of a single,~     integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan~     children aged 5 to 12 with persistent asthma who are living in homes with pests. By~     demonstrating cost effectiveness, this study could provide the basis for health insurance~     coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients~     living with pests.~      Asthma is the most common childhood disease in New York City, and both prevalence and~     hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and~     community-level factor associated with asthma disparities is varying exposure to triggers in~     the home, most notably cockroaches and mice. Asthma health care costs are significant, and~     prevention efforts to reduce triggers could result in improved outcomes and significant cost~     savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests~     and prevents re-infestation by addressing housing conditions conducive to pests and with~     safe, targeted use of pesticides. This project targets low-income children with the~     potential to significantly improve their health and well-being. A total of 400 families -~     400+ children which includes screened and recruited siblings - will be recruited on to the~     study.~      The study is designed to evaluate an inexpensive and scalable environmental intervention for~     asthma that can be replicated in other New York City neighborhoods and incorporated into any~     urban healthcare setting in New York State and nationwide.~   "
27250|NCT02700529|"~     Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and~     is elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene~     A4 hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is~     designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150~     mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in~     patients with secondary leg lymphedema. The primary objectives for the study are:~        -  To evaluate the efficacy of ubenimex in patients with secondary leg lymphedema~        -  To evaluate the safety and tolerability of ubenimex in patients with secondary leg~          lymphedema~   "
27251|NCT02700516|"~     Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of~     patients who receive a renal transplant. The exact prevalence of either recurrent or de novo~     GN is unknown since a considerable number of patients never undergo allograft biopsy,~     leaving GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN~     on the prevalence, risk factors, clinicopathological features, and outcome of renal~     transplant recipients.~   "
27252|NCT02700503|"~     This study uses patient engagement to develop a diabetes prevention program focused on~     adolescents and families.~   "
27253|NCT02700490|"~     This study is a cluster randomised controlled trial, which aims to examine the short-term~     strategy of addressing treatment gap through increasing primary mental health service~     capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a~     specialist model of mental health care and an enhanced usual care (task-sharing) framework,~     in terms of reducing mental health symptoms, reducing disability, and improving quality of~     life, as well as the health services costs (and potentially societal costs) associated with~     these outcomes in 400 patients.~   "
27254|NCT02700477|"~     Trigonella Foenum-Graecum, commonly known as Fenugreek, is a plant that has been extensively~     used as a source of anti-diabetic compounds Fenugreek is traditionally used in India,~     especially in the Ayurvedic and Unani systems.~      Preliminary animal and human trials suggest possible hypoglycemic and anti-hyper lipidemic~     properties of Fenugreek seed powder, when taken orally. Fenugreek seeds contain 50% fiber~     (30% soluble fiber and 20% insoluble fiber) that can slow the rate of post-prandial glucose~     absorption. This may be a secondary mechanism for the hypoglycemic effect.~   "
27255|NCT02700464|"~     Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder~     EpiCheck test compared to the gold standard cystoscopy and pathology in patients under~     monitoring for recurrence of bladder cancer.~   "
27270|NCT02700269|"~     Investigators will evaluate approaches using magnetic bead capture, isolation, and surface~     tension valve transfer of biomarkers to process capillary blood in order to improve the~     sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria~     infection. Results will be compared to those obtained using unenhanced capillary blood~     specimens directly applied to approved malaria RDTs. Participants seeking care for possible~     malaria in Zambia will be recruited to enroll in the study.~   "
27256|NCT02700451|"~     Patients undergoing spine surgery often have considerable pain post-operatively and~     frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control~     their pain postoperatively. The widespread use of opioids, however, is associated with a~     number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation,~     dizziness and itching amongst others. Some investigators have suggested that~     anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and~     acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as~     a result, lower opioid-related side effects.~      The purpose of this study is to test this hypothesis and determine if postoperative~     anti-inflammatory medications and postoperative acetaminophen can reduce the amount of~     opioid required to control pain following surgery. A secondary goal of this study is to~     examine if the change in pain medication will lead to decreased overall pain levels,~     decreased opioid-related side effects and improved function [quicker ambulation with~     physical therapy (PT), earlier return to work, etc.].~   "
27257|NCT02700438|"~     A prospective randomized study was performed. Compliance with the treatment and healing rate~     of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and~     subjects undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .~   "
27258|NCT02700425|"~     The goal of this study is to compare the effectiveness of pacing from a physiologic His~     bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in~     subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While~     placement of left ventricular leads via the coronary sinus has anatomic limitations, we~     hypothesis that the achievement of QRS narrowing with His bundle capture will be superior~     for improving systolic function by echocardiographic indices (ejection fraction and strain)~     and quality of life and decreased rehospitalization and mortality.~   "
27259|NCT02700412|"~     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various~     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating~     debilitating, drug-resistant epilepsy.~   "
27260|NCT02700399|"~     The purpose of this study is to determine if the pulse pressure changes are different~     whether patients are training in a traditional tilt table as compared to a robotic assisted~     tilt table, which induces leg movement.~   "
27261|NCT02700386|"~     The proposed study is being done to learn more about a particular dose of radiation~     treatment for breast cancer that is completed in a shorter amount of time than what has~     traditionally been used to treat breast cancer. Subjects are being asked to be in this~     research study because they have already had surgery for breast cancer and some cancer cells~     were found in their lymph nodes that drain the breast tissue.~   "
27262|NCT02700373|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study to~     assess the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to~     placebo.~   "
27263|NCT02700360|"~     A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the~     Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral~     Administration in Healthy Volunteers~   "
27264|NCT02700347|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and~     whole blood bactericidal activity (WBA) will be measured in healthy volunteers following~     administration of pyrazinamide alone and in combination with allopurinol.~   "
27265|NCT02700334|"~     Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired~     fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of~     progression type 2 diabetes mellitus (T2DM).~      Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2)~     co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion~     through urine, so that the blood glucose is improved in patients with T2DM. Although this~     mechanism is independent of insulin, there are evidence of improved secretion and insulin~     sensitivity, so it is interesting to assess these effects in patients with prediabetes, as~     potential therapy for treating such disorders and prevent progression to T2DM.~      The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and~     insulin sensitivity in patients with prediabetes.~      The investigators hypothesis is that the administration of dapagliflozin improve insulin~     secretion and insulin sensitivity in patients with prediabetes.~   "
27266|NCT02700321|"~     The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more~     efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal~     intubation after crash induction in non severely hypoxemic patients~   "
27267|NCT02700308|"~     Conventional vertebroplasty is an effective option in the treatment of bone lesions~     (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at~     reinforcing a compressed vertebrae or at risk of fracture.~      The main adverse event related to vertebroplasty use is the cement leakages that might be~     responsible for significant clinical impairments.~      Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on~     balloon through the needle into the targeted vertebrae and then inflation of the balloon~     prior to cement injection into the space.~      In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.~      To date, no data from randomized study are available in the population of cancer patients.~   "
27268|NCT02700295|"~     Orthokeratology has the benefit for slowing down myopia progression and enabling unaided~     vision during the day. To investigate proposed possible changes of conventional and~     multifocal orthokeratology in the cornea and choroid this study will image both structures~     with high resolution optical coherence tomographs over a six month period. Findings will~     help to plan larger trials over a longer period of time in adults and teenagers.~   "
27269|NCT02700282|"~     Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a~     progressive decline in lung function.~      School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack~     carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle~     strength is also impaired.~      No studies assessed aerobic capacities during children's gait while carrying a backpack.~      The investigators hypothesized that backpack carrying will induce an acute decline in lung~     function in children with cystic fibrosis compared to healthy children. Investigators also~     hypothesized that aerobic capacities will be impaired.~   "
27273|NCT02700230|"~     This phase I trial studies the side effects and the best dose of a vaccine therapy in~     treating patients with malignant peripheral nerve sheath tumor that cannot be removed by~     surgery (unresectable) or has come back after a period of improvement (recurrent). Vaccines~     made from a gene-modified virus may kill tumor cells expressing a gene called neurofibromin~     1 (NF1) without affecting surrounding normal cells and may also help the body build an~     effective immune response to kill tumor cells.~   "
27274|NCT02700217|"~     About 1100 living donor nephrectomies are performed in the UK every year contributing to~     almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general~     employed for donor nephrectomy as they are associated with a shorter hospital stay and~     faster return to normal physical functioning. Local anaesthetic infiltration technique with~     or without spinal anaesthesia in combination with a general anaesthetic is increasingly~     being used as part of enhanced recovery programme across general surgery. The impact of~     combined spinal and general anaesthesia along with local infiltration and rectus sheath~     blocks on acute pain has not been studied in patients undergoing hand assisted laparoscopic~     live donor nephrectomy.~      The investigators plan to investigate whether adding a spinal anaesthetic to a conventional~     general anaesthetic technique actually influences clinical outcomes of length of hospital~     stay and acute pain in patients undergoing hand assisted laparoscopic live donor~     nephrectomy.~      The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live~     donor nephrectomy over 24 month period at Central Manchester University hospitals and divide~     them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal~     anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus~     sheath group) and local anaesthetic infiltration~   "
27275|NCT02700204|"~     This is an open-label, two-arm, histological evaluation study.~      Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to~     receive PicoWay fractional treatment:~      Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for~     peri auricular and/or Buttocks according the Investigator decision, with the fractional~     hand-piece~      All subjects will have biopsies from the treated area:~        -  at baseline prior to treatment;~        -  immediately after treatment (within 30 minutes) or 48 hours after treatment;~        -  2 months after treatment. Methodology described in the protocol to evaluate efficacy~          and safety of treatments will be carried out at each visit at the clinic.~   "
27276|NCT02700191|"~     Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be~     given the µ-Cor system to be added to their standard care, and randomized 1:1 to an~     interventional arm or a control arm.~   "
27277|NCT02700178|"~     This study will evaluate movement of the arm and forces put through the hand during~     activities performed in a manual wheelchair. The goal of this study is to identify what~     motions and forces are most likely to lead to the development of pain or pathology and~     determine the feasibility of strategies to modify movements and decrease risk.~   "
27278|NCT02700165|"~     The purpose of this study is to further evaluate the safety and efficacy of non-invasive~     reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.~   "
27279|NCT02700152|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the~     UltraShape treatment for non-invasive abdominal fat reduction.~      Study subjects will undergo UltraShape treatments on the abdominal area~   "
27280|NCT02700139|"~     The aim of this clinical trial is to compare the rate of myopic progression in children~     wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design~     is an aspheric lens which is supposed to slow myopic progression in children by unique~     asphericity (proprietary information). Myopic progression is quantified by changes in axial~     length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6~     months crossover) with double-masking. Peripheral refraction and ocular aberration will be~     evaluated.~   "
27281|NCT02700126|"~     In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is~     frequently used due to brain relaxation and less effect on electrophysiologic monitoring.~     Response to propofol can vary between individuals and be associated with clinical factors~     including age and weight, and genetic polymorphism. Because the importance of rapid recovery~     in neurosurgery with long operation time is emphasized recently, the choice and dose~     adjustment of anesthetics should be determined according to clinical and genetic factors.~     Recently, researches about genetic variations have been performed with single nucleotide~     polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol~     recovery and response in Korean adult population undergoing propofol based TIVA for clipping~     of unruptured cerebral aneurysm.~   "
27282|NCT02700113|"~     The purpose of this study is to provide a detailed description of language and cognitive~     profiles found among children and adolescents diagnosed with autism spectrum disorders~     (ASD). Participants with ASD ages 4-17;12 years who have limited verbal skills will be given~     comprehensive behavioral assessments to collect data that will advance our understanding of~     language-related processes in individuals with ASD, the knowledge of which will help in~     designing future interventions for this population.~   "
27283|NCT02700100|"~     The study is a prospective, non-randomised, open label clinical study to assess the safety~     of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22~     years of age, undergoing Right Ventricular Outflow Tract (RVOT) reconstruction. It is a~     first in man feasibility study which will include 10-12 patients in up to 6 sites in Europe.~      The primary objective of the study is to assess the survival rate of subjects at 6 months~     following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001).~      Secondary objectives:~        1. The survival rate of subjects at 12 months following implantation of the Bioabsorbable~          Pulmonary Valved Conduit (PV-001)~        2. The percentage of conduit failure at 6 months and 12 months, where conduit failure~          includes the need for reintervention or reoperation.~        3. The pressure gradient across the pulmonary valve will have an acceptable level at 12~          months follow up.~        4. The pulmonary regurgitation measured will not exceed a moderate grading at 12 months~          follow up.~        5. To evaluate the usability of the Bioabsorbable Pulmonary Valved Conduit (PV-001) during~          the surgical procedure, using exploratory parameters~      Long term safety will be assessed up to 60 months post implantation.~   "
27330|NCT02699489|"~     A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and~     open donor nephrectomy within a specified enhanced recovery protocol~   "
27284|NCT02700087|"~     All neonates, ages 0 to 4 months, presenting to LPCH pediatric ENT clinic for airway~     difficulties or stridor will be screened for inclusion. As is consistent with an acceptable~     standard of medical care, these children will undergo a flexible nasal endoscopic exam to~     make the diagnosis of laryngomalacia, as well as be weighed and a breastfeeding history~     taken. If laryngomalacia is present, the study staff with then administer the Infant~     Gastroesophageal Reflux Questionnaire (IGERQ) and an airway symptoms questionnaire (ASQ).~      Those babies with an IGERQ score of less than sixteen (no more than mild reflux) and an ASQ~     score greater than six will be eligible for randomization. The patient will then be randomly~     placed in the control group (placebo) or the intervention group (ranitidine 2mg/kg every 12~     hours or famotidine 0.5 mg/kg daily). Patients will stay on medication for a minimum of 6~     months, or until symptoms resolve. Patients will be seen in follow up at 1, 2, 3, 4, 5, 6, 8~     and 10 months. At which time I-GERQ, ASQ and weights will be taken. The primary outcome~     measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine~     versus placebo.~      A secondary outcome will be weight gain in percentile. If the patient's I-GERQ score goes~     above 16 at any time in the study, the patient will be crossed over to the treatment arm and~     started on medical treatment.~   "
27285|NCT02700074|"~     The main goal of our study is to find out why some people with Autism Spectrum Disorder~     (ASD) do not develop verbal abilities or remain minimally-verbal throughout adolescence and~     adulthood. Current research focuses on investigating brain differences related to processing~     sounds and initiating speech in adolescents and young adults with ASD varying in language~     skills, compared to adolescents who do not have ASD, in order to clarify whether atypical~     processes of auditory perception, perceptual organization and/or neural oscillation patterns~     may explain why some individuals with ASD fail to acquire functional speech.~   "
27286|NCT02700061|"~     The purpose of this study is to evaluate and compare the effects of upper limb training with~     Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor~     function, neurological evaluations and quality of life are assessed for the comparison of~     the therapies.~   "
27287|NCT02700048|"~     This is a single center, single-blind randomized cross over design trial that will compare~     the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental~     hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators~     intend to enroll 18 individuals to obtain the complete data sets from 15 participants.~     Expected duration of subject participation is 10-12 weeks. This study will consist of two~     2-day intervention visits separated by approximately 8 weeks.~   "
27288|NCT02700035|"~     This study will complete a multisite randomized controlled trial (RCT) of a family-centered~     alcohol and drug prevention program for Anishinabe (Ojibwe) pre-adolescents aged 8-10 years.~     The 14 week program includes cultural lessons to strengthen family interactions, decrease~     substance use, teach parenting skills, increase social skills, improve refusal skills, and~     teach coping mechanisms for adolescents and parents. Session are expected to last around~     3-hours, including a meal, youth and parent breakout sessions, and group based discussions.~     Parents and adolescents will participate in a pre-test before the program begins and a~     series of post-tests after the program ends.~   "
27289|NCT02700022|"~     This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD,~     which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor~     alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin,~     vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large~     B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for~     Myc gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle~     of R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL~     population will be opened to further characterize clinical activity and safety.~      Secondary objectives include estimates of complete response rate (CR) and progression free~     survival (PFS). We will also explore for associations between baseline kinome signatures~     and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to~     and during treatment.~   "
27290|NCT02700009|"~     Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be~     effective in previous studies in psychiatric settings, will be disseminated into primary~     care - a health care setting where there are significant problems in receiving adequate~     treatment for depression. Computer-assisted cognitive-behavior therapy will feature a~     low-cost method of delivering therapy designed to be replicated and sustained in other~     primary care settings. Feasibility and effectiveness will be tested by randomly assigning~     320 primary care patients with depression to receive either computer-assisted~     cognitive-behavior therapy or treatment as usual.~   "
27291|NCT02699996|"~     This partially randomized pilot trial studies peer mentoring to see how well it works in~     promoting follow-up care self-management in younger childhood cancer survivors. Childhood~     cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and~     psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors.~     A peer mentoring program may improve disease knowledge, health motivation, problem-solving~     skills, stress management, and communication with caregivers and providers in adolescent and~     young adult cancer survivors.~   "
27292|NCT02699983|"~     This randomized pilot clinical trial studies how well a virtual weight loss program~     (SparkPeople) works in helping female African American breast cancer survivors maintain a~     healthy weight. Many patients with breast cancer are overweight or gain weight after~     diagnosis. SparkPeople is a free web-based weight loss program that features educational and~     motivational articles and videos, self-monitoring tools, incentives, social support~     communities (including discussion forums, teams, challenges, and expert blogs), and options~     for content to be delivered to members' email. It is a comprehensive program that includes~     advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet~     and exercise), and emphasizes safe weight loss and receiving medical attention regularly~     when needed. A web-based program such as SparkPeople may help breast cancer survivors~     maintain a healthy weight, which may reduce the risk of cancer returning and patient~     fatigue, and improve patient quality of life.~   "
27293|NCT02699970|"~     The objective of this study is to evaluate precision of the Philips Dx system.~   "
29251|NCT02674269|"~     The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained~     release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive~     bladder.~   "
27294|NCT02699957|"~     The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the~     prevalence, demographics, management, and outcomes of patients undergoing percutaneous and~     epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke.~     Patient-level data will be submitted by participating hospitals on a quarterly basis to the~     American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR).~     The primary aims of the LAAO Registry are to optimize the outcomes and management of~     patients through the implementation of evidence-based guideline recommendations in clinical~     practice, facilitate efforts to improve the quality and safety for patients undergoing~     percutaneous and epicardial based left atrial appendage procedures, investigate novel~     quality improvement methods and provide risk-adjusted assessment of patients for comparison~     with nationwide NCDR data. The secondary purpose of the LAAO Registry is to serve as a rich~     source of clinical data to support assessments of short- and long-term safety, comparative~     and cost effectiveness research, and as a scalable data infrastructure for post market~     studies.~   "
27295|NCT02699944|"~     Despite advancements in implant technology and various techniques of optimization, there is~     still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study~     will assess the potential benefit of a body surface mapping technology to optimize CRT~     devices in the chronic sub-optimal responder setting.~   "
27296|NCT02699931|"~     This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and~     pulsation) are more effective than manual toothbrushes in removing plaque and reducing~     gingival inflammation in patients under orthodontic treatment with fixed appliances.~   "
27297|NCT02699918|"~     Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the~     extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study~     design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation~     will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an~     abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep~     apnea syndrome. Patients with sleep apnea will be treated.~      Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and~     cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.~   "
27298|NCT02699905|"~     This study seeks to elucidate the quantitative expression of G - protein receptor 43/free~     fatty acid (GPR43/FFA2) receptors in patients with the diagnosis of sepsis and specifically,~     its expression as it relates to the severity of sepsis. The investigators hypothesize that~     patients with more severe sepsis, as defined by a higher SOFA (Sequential Organ Failure~     Assessment Score), will have decreased expression of the GPR43/FFA2 as compared to patients~     with lower SOFA scores, consistent with a less exuberant immune response to infection.~      Patients admitted to Penn State Hershey Medical Center with a diagnosis of sepsis of any~     cause will undergo blood testing of leukocytes to determine the expressed quantity of GP43~     during standardized time points of their illness and recovery. No interventions will be made~     in the standard clinical management of the patient. Additionally, healthy volunteers will be~     recruited to exam baseline GPR43 receptor expression between sepsis and control groups.~   "
27299|NCT02699892|"~     This Phase IV post-marketing, non-interventional, open label, non-comparative and~     prospective study will examine the efficacy and safety of rituximab in participants who had~     previously received rituximab in terms of everyday medical practice. Efficacy and safety of~     rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the~     second infusion repeated courses of treatment (if the participants receive another course of~     rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the~     participants receive third course of rituximab). Protocol does not specify the criteria for~     initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab~     will be administered at the discretion of treating physician according to approved label.~   "
27300|NCT02699879|"~     This single arm, post-authorisation study is designed to evaluate the long-term safety of~     pirfenidone in participants with IPF. The enrolment of participants will be completed within~     approximately 24 months. Participants will receive pirfenidone according to the physician~     discretion and will be followed for 2 years. Treating physicians will collect pre-specified~     data at the baseline and every 3 months thereafter, for the duration of the participants'~     participation in study.~   "
27301|NCT02699866|"~     The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow~     treatment of patients with single tooth gaps of small dimensions in the lateral and central~     incisor positions in the mandible and in the lateral incisor positions in the maxilla. These~     positions are reduced-load-bearing compared to more posterior positions.~      During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the~     clinical practice setting will be investigated.~   "
27302|NCT02699853|"~     This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open~     radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a~     surgical procedure to remove all or part of the bladder (the organ that holds urine) or to~     remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in~     the abdomen and uses a thin, lighted instrument with a camera attached called a scope. With~     the help of a robot, the surgeon removes the bladder and other nearby structures. In ORC,~     the surgeon makes a cut into the lower abdomen to expose the urinary tract in order to~     remove the bladder and nearby structures. It is not yet known whether RRC or ORC has fewer~     complications, better quality of life, and faster recovery time in treating patients with~     bladder cancer.~   "
27303|NCT02699840|"~     The aim of this study is to generate local data on the safety of Menactra® in individuals 2~     to 55 years of age in the Russian Federation.~      Primary Objective:~        -  To describe the safety profile after 1 dose of Menactra® administered in individuals~          2-55 years of age under standard health care practices.~   "
27304|NCT02699827|"~     This study aims at evaluating the effect of adding magnesium sulphate epidurally as an~     adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in~     patients with preeclampsia undergoing elective caesarian section (CS).~   "
27331|NCT02699476|"~     The purpose of this study is to compare different combinations of cognitive training in~     retired professional football players and military veterans with a history of repeated~     concussions and persistent symptoms of impaired memory, concentration, attention, focus, or~     thinking.~   "
27305|NCT02699814|"~     The goal of this project is to develop and pilot test a community-based integrated care~     model to improve the prevention, early detection and treatment of child mental health~     problems that is replicable, effective, and sustainable. Project procedures include child~     mental health screening, on-site brief mental health interventions, referral to specialty~     mental health, use of co-located child psychiatrist, detection of need for primary care in~     specialty mental health program. Subjects will be enrolled for 1 year, with interviews at~     baseline and 3, 6 and 12 months.~      Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement~     the evaluation of the project, which includes developing data collection procedures,~     training staff on implementation of data collection workflow, coordinating with sites to~     ensure evaluation design and IRB protocols are followed, and coordinating with both study~     sites to verify data reliability.~      Some potential anticipated risks include being uncomfortable answering questions associated~     with the measures used in the study, and although unlikely, someone may access participant~     information that is confidential. Some benefits include helping to find ways to improve how~     to deliver mental health care for children served in publicly-funded primary care and mental~     health clinics.~   "
27306|NCT02699801|"~     Increasing numbers of elderly patients are undergoing cardiac surgery. Elderly patients may~     have prolonged recovery following cardiac surgery when compared to other groups of patients,~     and are at higher risk of postoperative delirium, postoperative neurocognitive decline and~     reduced quality of life following hospital discharge.~      The goals of sedation and analgesia for patients following cardiac surgery are multifold and~     include postoperative pain relief, the facilitation of ventilation, resolution of~     hypothermia and normalization of electrolyte balances. The choice of sedative agent however~     can impact postoperative outcomes. Dexmedetomidine has been associated with improved quality~     of recovery in patients undergoing major spine surgery and with a reduced incidence of~     delirium, both of which can impact a patient's quality of life following surgery. The~     investigators hypothesized that the use of dexmedetomidine as a sedative agent immediately~     following cardiac surgery in elderly patients would result in improved quality of recovery~     and a reduced incidence of delirium in the postoperative period, when compared to propofol.~     The investigators were also interested as to whether there was an associated improvement in~     neurocognitive outcomes in this population.~      Questions:~        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients~          following cardiac surgery result in improved Quality of Recovery scores when compared~          with propofol?~        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients~          following CABG+/- AVR result in a reduced incidence of postoperative delirium as~          compared to propofol?~        -  Do these patients subsequently have a reduction in cognitive decline?~   "
27307|NCT02699788|"~     The goal of this study is to assess a new non-invasive computerized, multiphase, resting~     electrocardiogram analysis device in early identification of patients at risk for acute~     coronary syndrome. The overall objective is to assess the association between the results~     from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency~     department with suspected coronary disease.~   "
27308|NCT02699775|"~     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity~     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies~     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved~     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of~     repetitive multifocal BTI on patient's gait pattern and their duration.~      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic~     stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after~     3 consecutives BTI sessions.~   "
27309|NCT02699762|"~     To show that the addition of a self-rehabilitation program to standard treatment, involving~     repeated BTI and usual physiotherapy, improves impairment and activity limitation of the~     paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a~     randomised controlled study of patients with spastic hemiparesis following stroke.~   "
27310|NCT02699749|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),~     and maximum tolerated dose (MTD) of TAK-931 in participants with advanced nonhematologic~     tumors.~   "
27311|NCT02699736|"~     The EuroSIDA study is a prospective observational cohort study of 20,000+ patients followed~     in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest~     pan-European cohort study and few studies of a comparable design are available on a global~     scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into~     the study through 10 cohorts since 1994.~      The main objective of the study remains the same as in1994: to prospectively study,~     clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive~     persons across Europe in order to determine their long-term virological, immunological and~     clinical outcomes.~      Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such~     as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy~     (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected~     patients, it is important for EuroSIDA to remain in the forefront of investigating the~     treatment benefits and adverse effects.~      All study documents, study status, newsletters, scientific publications and presentations~     are available online and are updated continuously at project website.~      In general terms, the objective of the EuroSIDA study is to continue a long-term,~     prospective collection of clinical, laboratory and therapeutic data as well as plasma on a~     large cohort of consecutive HIV infected patients from across Europe in order to (1) assess~     the factors associated with the clinical, immunological and virological course of HIV~     infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and~     develop a surveillance system to describe temporal changes and regional differences in the~     clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.~   "
27312|NCT02699723|"~     This pilot clinical trial studies how well arsenic trioxide and itraconazole work in~     treating patients with basal cell cancer that has spread to other places in the body and~     usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as~     arsenic trioxide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Itraconazole may help treat fungal infections in patients with basal cell cancer. Giving~     arsenic trioxide with itraconazole may work better in treating basal cell cancer.~   "
27332|NCT02699463|"~     The investigators wish to prospectively determine the response to CPAP in patients~     presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are~     not reimbursed for treatment. Although some evidence exists of the benefits of treating mild~     OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish~     to add to this pool of knowledge and also increase the inclusion criteria to include the~     AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the~     investigators will add novel information to the field by assessing the benefits of treatment~     in both sub-groups of mild OSA.~   "
27313|NCT02699710|"~     This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part~     study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to~     investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy~     male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence~     study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the~     effect of simultaneous administration of a single dose of methotrexate on the steady-state~     kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose~     PK of methotrexate in healthy male participants.~   "
27314|NCT02699697|"~     This randomized phase II trial studies how well palliative radiation therapy works in~     reducing pain in patients with cancer that has spread from the original (primary) tumor to~     the bone (bone metastasis). Palliative radiation therapy using external beam radiation~     therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by~     cancer.~   "
27315|NCT02699684|"~     The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses~     compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.~   "
27316|NCT02699671|"~     The purpose of this study is to evaluate the relative effectiveness and safety of~     Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug~     eluting stents) DES.~   "
27317|NCT02699658|"~     Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a~     broad spectrum of activity. In common with other fluoroquinolones, the main~     pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy~     is the area under the plasma time-concentration curve/the minimum inhibitory concentration~     ratios.~      The aims of the study were to:~        1. reveal the population pharmacokinetics, and~        2. assess the efficacy of various dosage regimens in achieving the probability of target~          attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when~          oral levofloxacin was prescribed as the switching therapy after intravenous~          levofloxacin treatment.~      The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of~     levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to~     determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens~     were predicted to achieve CFR greater than or equal to 90%.~   "
27318|NCT02699645|"~     An investigator initiated and conducted, multicentre, international, double-blinded,~     placebo-controlled, parallel-group, randomised controlled trial to determine the effects of~     a fixed low-dose combination blood pressure lowering pill (Triple Pill) on top of standard~     of care on blood pressure control and on time to first occurrence of recurrent stroke in~     patients with a history of acute intracerebral haemorrhage (TRIDENT).~   "
27319|NCT02699632|"~     The main goal for this study is to assess concerns and barriers to research participation by~     pregnant women through an anonymous online survey~     (www.pbrc.edu/ParticipateWhilePregnantSurvey).~   "
27320|NCT02699619|"~     Femoral neck fractures represent about half of the hip fractures and are further divided~     into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always~     treated surgically with arthroplasty. However there is an ongoing debate on which implant is~     superior for undisplaced fractures.~      A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the~     original implant consisted of 2 isolated hook pins, the modified design consists of 3~     titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of~     implant design and improves fixation and load transfer amongst the pins. The superiority of~     the modified design is so far only proven preclinically.~      The role of the Pinloc in clinical use remains unclear. Investigators are planning a~     randomized controlled trial on undisplaced femoral neck fractures to establish a method for~     implanting the tantalum markers, to observe the fracture healing process and to further~     investigate the role of the Pinloc.~   "
27321|NCT02699606|"~     The primary purpose of this study is to evaluate objective response rate (ORR) as per~     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a~     molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC),~     urothelial cancer, esophageal cancer and cholangiocarcinoma.~   "
27322|NCT02699593|"~     This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test~     and control lenses in random succession. The objective is to evaluate materials from~     different suppliers.~   "
27323|NCT02699580|"~     This study is to investigate protective effect of biodegradable collagen implant in scleral~     showing after lateral rectus recession in patients with exotropia.~   "
27324|NCT02699567|"~     The purpose of this study is to determine the effect of common human variants in in taste~     related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste~     perception.~   "
27325|NCT02699554|"~     Impaired neuromuscular control hinders movement for individuals with cerebral palsy and~     other neurological disorders. In this research, the investigators are developing new tools~     to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one~     of the most common treatments, orthopaedic surgery. The results from this research will~     empower clinicians to identify patient-specific factors that contribute to impaired movement~     and improve treatment and quality of life.~   "
27326|NCT02699541|"~     In this study, researchers will test the effectiveness of a self-management education~     programme, on self-management behaviours of patients with type two diabetes. Up to 230~     consenting participants recruited from a Diabetes clinic in Jordan, will be randomised to~     one of two groups. Group 1 (115 patients) will receive the intervention, which consists of~     an introductory session of tailored, face-to-face education and advice, followed by~     educational materials to take away, and regular telephone support at a regularity specified~     by the patient, over a three-month period. This intervention is based on behavioural change~     theory called the Information-Motivational-Behavioural skills model. Group 2 (115 patients)~     will receive usual clinical care with no additional intervention. Researchers will assess~     the effectiveness of the intervention by measuring self-care strategies (dietary habits,~     physical activity and managing diabetes medications), diabetes control (HbA1c), quality of~     life and Diabetes Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points:~     before the intervention, at 3 months and at 6 months.~   "
27327|NCT02699528|"~     To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in~     children with attention deficit disorder~   "
27333|NCT02699450|"~     This is a multiple-center, multiple-dose, randomized, active comparator-controlled,~     double-masked, three parallel group, 28-week study in participants with CI-DME. Only one eye~     will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye~     with the worse best corrected visual acuity (BCVA) will be defined as the study eye.~     Participants will be randomized into each arm group (1:1:1) and total duration of the study~     will be approximately 32 weeks.~   "
27334|NCT02699437|"~     The purpose of this study is to determine the prevalence of positive antiphospholipid~     antibodies among women with preeclampsia and to determine the effect of antiphospholipid~     antibodies on the severity of preeclampsia and the obstetric outcomes~   "
27335|NCT02699424|"~     This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy.~     Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to~     the prostate bed and thereafter be classified as either responders or non-responders~     depending on PSA response at fifth week of radiotherapy.~      A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment~     week in order to identify cancer lesions in patients with poor PSA response. Patients with~     PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst~     patients with poor PSA response may be in need for additional therapy such as radiotherapy~     to lymph node metastases and/or boost fractions to local recurrence. Patients with more than~     3 lymph node metastases or distant metastases will not receive any more radiotherapy, but~     individualized systemic therapy will be started.~   "
27336|NCT02699411|"~     We will conduct a randomized clinical trial observing forty patients divided into two~     groups: one group composed of twenty individuals undergoing surgery for ruptured ACL, which~     perform dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform~     techniques proprioception (group a); and twenty patients not be treated with dry needling~     after ACL surgery, using only proprioceptive exercises to the joint (group B).~   "
27337|NCT02699398|"~     The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is~     superior than domiciliary occupational therapy for inducing functional gains, enhancing~     corticospinal excitability, and cortical reorganization.~   "
27338|NCT02699385|"~     The purpose of this study is to demonstrate that domperidone suspension plus oral~     rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms~     of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of~     treatment administration in pediatric participants with AG and mild-to-moderate dehydration.~   "
27339|NCT02699372|"~     This randomized, single center, adaptive single ascending dose (Part 1) and multiple~     ascending dose (Part 2) study is designed to assess the safety, tolerability,~     pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus~     placebo in healthy volunteers. The anticipated duration of this study is approximately 18~     weeks.~   "
27340|NCT02699359|"~     The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic~     signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also~     shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral~     blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the~     absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any,~     that may exist between concussion, timing of the concussion (e.g. acute, resolving,~     resolved) and ICP is unknown. The new HS-1000 non-invasive device may provide insight into~     assessment of possible ICP changes following concussion in children.~   "
27341|NCT02699346|"~     The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely~     and accurately monitor concussed patients with minimal discomfort, potentially providing a~     new modality for concussion measurement. The device is based on advanced signal analysis~     algorithms that analyze a very low frequency acoustic signal (within the audible range)~     generated by the device. The acoustic signal is transmitted using a small transmitter,~     placed in the participant's ear, and picked by an acoustic sensor placed in the other ear.~   "
27342|NCT02699333|"~     Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly.~     Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology~     is unknown. Understanding the etiology of microscopic colitis is an important step in~     developing logical interventions to decrease the burden from microscopic colitis. This~     research could provide critical insights into the etiology of this poorly studied condition.~   "
27343|NCT02699320|"~     There are no reports involved the intestinal microbiota from Chinese infants with short~     bowel syndrome (SBS) under different clinical status. Alterations in the microbiota are~     closely correlated with the bile acids and short chain fatty acids metabolism as well as the~     intestinal immunity. A relatively comprehensive profile composed of microbial structure,~     microbial metabolism products and immune biomarkers in SBS infants may facilitate a better~     therapy strategy to complications occurred in SBS children.~   "
27344|NCT02699307|"~     Physical activity is the cornerstone of good diabetes management, and yet effective physical~     activity intervention is not available. The investigators developed a lifestyle intervention~     based on individual's home activity patterns. The goal of the study is to test the efficacy~     of this intervention among older adults with diabetes. In addition to physical activity, the~     investigators will also assess if the intervention will improve social participation.~   "
27345|NCT02699294|"~     This randomised-controlled trial investigates whether a single intervention of manual~     pressure release combined with stretching exercise has an effect on muscle length, pain~     perception threshold, and respiratory function in subjects with latent myofascial trigger~     point in the pectoralis minor muscle or not. First quarter of the participants will receive~     a single intervention of manual pressure release combined with contract-relax PNF stretching~     exercise of pectoralis minor muscle, second quarter of the participants will receive a~     single intervention of manual pressure release combined with Z stretching exercise of~     pectoralis minor muscle while, only a single intervention of manual pressure release will be~     applied to third quarter of the participants and final quarter of them will not receive any~     intervention.~   "
27399|NCT02698566|"~     This is a multicenter study designed to evaluate usability of Lucentis prefilled syringe~     (PFS) in participants with neovascular age related macular degeneration or macular edema~     secondary to retinal vein occlusion.~   "
27346|NCT02699281|"~     Investigators planned to adopt the N-of-1 trial approach to objectively test the~     effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65~     years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca'~     Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any~     origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial~     including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will~     secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average~     effect of um-PEA compared with placebo using a frequentist and Bayesian approach.~   "
27347|NCT02699268|"~     This is a cross-sectional observational study, aiming to validate the accuracy of tidal~     breathing measurements in infants made by VoluSense Pediatrics, a lung function method based~     on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter.~     VoluSense Pediatrics consists of a flexible vest placed around the torso of the baby, and~     changes in tidal volume and flow is measured. The study will enable a better understanding~     of the usefulness of this equipment. The equipment is made by VoluSense Norway AS, and is~     owned by Haukeland University Hospital.~   "
27348|NCT02699255|"~     Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of~     over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with~     symptomatic atrial fibrillation. It is well known that this interventional therapy~     inevitably modulates the intracardiac autonomic nervous system. While this ablation might~     alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology~     remains unclear.~      The investigators study aimed to observe the occurrence of new premature ventricular~     complexes and other ventricular arrhythmias after pulmonary vein isolation.~   "
27349|NCT02699242|"~     The aim of the study is to study whether training by residents or anesthesia assistants, on~     a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance~     of fiberoptic intubation in patients.~   "
27350|NCT02699229|"~     For this study the investigators are looking to do the following:~        1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.~        2. To establish the first spectral/structural database for nonlinear optical microimaging~          of normal and abnormal lung tissue.~   "
27351|NCT02699216|"~     This study evaluates the treatment of Dry Macular Degeneration and the resulting change in~     vision with a very, very low current that is similar to what occurs in the body naturally.~     In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham~     (no treatment). After the treatment period of one week, those not treated will be treated.~     In Phase 2, all participants will be treated.~   "
27352|NCT02699203|"~     In addition to its role as the major regulator of glucose uptake into peripheral tissues,~     the hormone insulin is also a primary regulator of fat storage and fat burning of the body.~     Mechanistic animal studies have shown that high insulin may be the initial trigger for~     weight gain and be the proximal cause of obesity. There is currently no quick or~     non-invasive way of measuring insulin as research and clinical techniques require collection~     of a blood sample followed by a complicated and costly biochemical assay. The investigators~     will test the hypothesis that insulin levels can be accurately measured in saliva in humans~     following meals that elicit high and low blood insulin responses. Findings will help~     determine if insulin can be use as a valid fluid to track insulin changes in humans.~   "
27353|NCT02699190|"~     The purpose of this study is to establish the ability of Next-Generation Sequencing (NGS)~     technologies to provide a diagnosis in a group of participants with suspected leukodystrophy~     as determined by clinical symptoms, including MRI imaging, but without a specific genetic~     diagnosis. Cost-effectiveness and clinical utility of whole genome sequencing will also be~     investigated as part of the study.~   "
27354|NCT02699177|"~     1. Assessment of a high speed video camera with a green light source for the measurement~          of ciliary beat frequency (CBF) in the nasal airways of patients.~        2. Assessments of the effect of drugs and other therapies on CBF using the study system.~        3. Comparison of results with standard methods such as ciliary brush biopsies~   "
27355|NCT02699164|"~     This study was conducted with the aim of determining whether or not Non surgical spinal~     decompression therapy was effective in remission of herniation, decreasing pain and~     improving functional status.~   "
27356|NCT02699151|"~     Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities.~     Only in the last years a series of observational studies mainly conducted in France could~     show that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary~     embolism) is in fact not a benign and spontaneously healing disease but bears a potential~     for severe thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims~     at collecting representative data on the current management and outcomes of SVT in Germany~     under real-life conditions. It will document the implementation of the recently issued~     national SVT guidelines issued by the Society for Angiology (DGA) and the Society for~     Phlebology (DGP).~   "
27357|NCT02699138|"~     Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper~     airway. However, it is increasingly recognized that multiple additional non-anatomical~     mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic~     stress disorder (PTSD) than in those without PTSD have been reported however the mechanism~     behind this increased prevalence has not been investigated. Our hypothesis is that patients~     with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up~     too easily) than patients without PTSD. The goal of this project will be to study and~     compare the ArTH in patients with PTSD and those without. In addition, we plan to see~     whether medications can be used to increase the arousal threshold and treat OSA in patients~     with PTSD.~   "
27358|NCT02699125|"~     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.~     They often develop high blood pressure. We are not sure what drug is best to treat the high~     blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)~     for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24~     hour monitoring.~   "
27462|NCT02697734|"~     Purpose of study is to aim to confirm efficacy and safety of osilodrostat for the treatment~     of patients with Cushing's disease who are candidates for medical therapy~   "
27359|NCT02699112|"~     To assess patients with hypercapnic respiratory failure using echocardiography,cardiac~     output measurements and markers of neural respiratory drive (EMGpara) prior to, during and~     after non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months.~     The investigators hypothesize that the improvement in cardiac function and/or respiratory~     mechanics over time are associated with ongoing improvements in oxygenation, quality of life~     and exercise capacity.~   "
27360|NCT02699099|"~     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the~     SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and~     yellow fever vaccines to children aged 6 months at the first vaccination.~   "
27361|NCT02699086|"~     The purpose of this study is to evaluate the safety and efficacy in adult patients with~     Attention-Deficit Hyperactivity Disorder (ADHD).~   "
27362|NCT02699073|"~     The purpose of the study is to evaluate the performance of various tumor response criteria~     (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.~      Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic~     texture analysis (CTTA)~   "
27363|NCT02699060|"~     This study is proposed to evaluate the role of motoric dysfunctions and burden of different~     kinds of refluxate on immune cells and the subsequent course of the disease. This study also~     aims to establish a bridge between instrumental findings (pH-impedance test) and clinical~     assessments (FSSG questionnaire), aiming to facilitate the use of simple questionnaire~     techniques in the clinical setting in the future.~   "
27364|NCT02699047|"~     Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty~     acids from fish oil concomitant chemotherapy in gastrointestinal cancer.~   "
27365|NCT02699034|"~     The purpose of this clinical study is to evaluate the and performance of the Imricor Medical~     Systems, Inc. (Imricor) MR Ablation Catheter when used with related accessories for the~     treatment of type I atrial flutter. The Vision Ablation Catheter and its accessories have~     been designed for use under fluoroscopic or magnetic resonance guidance. The study will be a~     single center study conducted at the Leipzig University Hospital Heart Center in Germany.~     The study population will consist of adult patients requiring ablation for type I atrial~     flutter.~   "
27366|NCT02697617|"~     Funding Source - FDA OOPD~      Pioglitazone is currently used in clinical practice to treat diabetes and this study will~     examine the potential use of a low dose of the same drug for the treatment of polycystic~     kidney disease. The purpose of this study is to determine whether the diabetes drug~     pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic~     kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the~     treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low~     dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest~     that effective pioglitazone dosing for polycystic kidney disease may be lower than that used~     to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst~     disease in humans.~   "
27367|NCT02699008|"~     High on-treatment platelet reactivity to adenosine diphosphate was a important reason to~     cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss~     the true HPR or over estimate HPR, which may lead to randomized trials failed. It is not~     known whether combined multiple platelet function testing could assist to ensuretureHPR~     and improve clinical outcomes.~   "
27368|NCT02698995|"~     Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a~     antiinflammatory steroid. Although the perineural administration is off-label, several~     studies recognised its analgetic action as an adjuvant for peripheral nerves blockade,~     permitting to reduce the concentration of the local anesthetics and extending the sensory~     and motor block.Questions remain concerning the mechanism of action, optimal dose, the~     lack/degree of toxicity and the comparison with intravenous administration.The aim of this~     prospective randomized controlled study is to investigate the efficacy of analgesia with 4~     mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in~     vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.~   "
27369|NCT02698982|"~     The aim of this study is to demonstrate that in elderly and frail patients, a narrower~     control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP~     monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of~     postoperative cognitive impairment and the hospital length of stay.~   "
27370|NCT02698969|"~     Diaphragm ultrasonography as a diagnostic tool in order to demonstrate the superiority of~     Sugammadex vs. AChEI in facilitating post-operative neuromuscular recovery.~   "
27371|NCT02698956|"~     This is an international, mutli-center, prospective, consecutively enrolled, observational~     registry. 2000 patients are planned to be enrolled over one year at up to 150 participating~     sites.~      300 patients out of the 2000 patients enrolled in the main registry are planned to be~     consecutively enrolled in a select few sites for studying the valve performance.~     Echocardiogram and angiogram will be taken routinely.~   "
27372|NCT02698943|"~     Posterior capsule opacification (PCO) and glistenings development is among the primary~     reasons for sub-optimal visual capacity following cataract extraction surgery. Primary~     objective of this study is to evaluate the incidence of PCO and glistenings of the popular~     envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who~     underwent phacoemulsification at least 1 year prior to their enrollment at the study~   "
27373|NCT02698930|"~     Acute kidney injury is major complication after open heart surgery. The cause of acute~     kidney injury following open heart surgery is related to activation of sympathetic nervous~     system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory~     response.~      Infective endocarditis patients undergoing open heart surgery have systemic inflammatory~     response associated with infective endocarditis. And the inflammatory response can be~     aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open~     heart surgery due to infective endocarditis was 50% in a previous report. And this acute~     kidney injury was related to the poor outcome and high mortality. Thus, the preventive~     method to protect kidney function will be needed in the patients with infective endocarditis~     undergoing open heart surgery.~      Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive~     effect. And several experimental study demonstrated the renal protective effect.~     Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed~     and suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine~     was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during~     the operation. Thus, these effects of dexmedetomidine can be expected to reduce the~     incidence of acute kidney injury.~      Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect~     and this effect might be related to the suppression of inflammatory response. Thus, the~     investigators will evaluate the incidence of acute kidney injury after open heart surgery~     due to infective endocarditis and the level of inflammatory mediators.~      The primary end point of this study is the incidence of acute kidney injury after open heart~     surgery due to infective endocarditis. And secondary end point is the level of cystatin C~     which is related to the renal function, the level of inflammatory mediator and the~     postoperative morbidities.~   "
27374|NCT02698917|"~     The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility, safety~     and effect on brain injury markers of targeting low or high normal arterial oxygen tension~     (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in~     comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using~     factorial design, participants are randomized at admission to intensive care unit to one of~     eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In~     this way, investigators will be assessing the feasibility and effect of all three variables~     at the same time.~      The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after~     cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP~     levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and~     ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and~     72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.~   "
27375|NCT02698904|"~     People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be~     exacerbated by psychological outcomes including anxiety and depression. Previous studies~     suggest that relaxation techniques may have positive effects on pulmonary rehabilitation.~     The main aim of this study is to explore both the respiratory and psychological impact of a~     quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary~     Disease (COPD).~   "
27376|NCT02698891|"~     This research study is testing the safety and feasibility of delivering the 4 cycles of~     'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte~     Colony-stimulating Factor (G-CSF) support. The research study is for participants who have~     early stage breast cancer and have been recommended to receive a standard chemotherapy~     regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a~     dose-dense fashion to prevent recurrences.~   "
27377|NCT02698878|"~     The present study aimed to investigate whether a daily intake of lupin protein and a~     neuromuscular electrical stimulation training twice a day can improve local glucose uptake~     into m. soleus during a 60 day unloading phase with a special unloading device, the~     HEPHAISTOS orthosis (HEP).~   "
27378|NCT02698852|"~     PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects~     from approximately 40 interventional cardiology centers will be enrolled to evaluate the~     target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be~     followed up to 5 years to attain the data of the secondary endpoints.~   "
27379|NCT02698839|"~     PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry~     trial. 539 subjects from about 40 interventional cardiology centers in China will be~     enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And~     all the subjects will be followed up to 5 years to attain the data of the secondary~     endpoints.~   "
27380|NCT02698826|"~     The broad objective of this study is to test the association between hyperoxia exposure~     after resuscitation from cardiac arrest and outcome. After obtaining written informed~     consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2)~     optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between~     subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2~     optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after~     return of spontaneous circulation (ROSC) is associated with increased oxidative stress and~     worsened neurological and cognitive outcomes.~   "
27381|NCT02698813|"~     The overall goal of this study is to evaluate the safety and exploratory efficacy of the~     injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic~     acid for the improvement of wrinkles, acne, pitting scar and so on.~   "
27382|NCT02698800|"~     Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that~     coincides with environmental darkness and endogenous melatonin secretion. Various factors,~     such as artificial light, can compromise this temporal harmony, resulting in sleep~     disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs~     via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms.~     Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical,~     since most individuals routinely expose themselves to light before bedtime. The high~     sensitivity of the circadian system to blue wavelength light indicates that modern light~     sources such as light-emitting diodes (LED) may have particularly deleterious effects on~     sleep. It is possible to selectively filter out blue light while maintaining other visible~     spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a~     simple, affordable, and safe method to improve sleep. None have yet investigated the effects~     of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously~     exploring the effects on melatonin secretion.~   "
27383|NCT02698774|"~     The purpose of these studies is to evaluate the experimental approaches and device designs,~     in order to improve diagnostic performance of the RDT only. The results from the enhanced~     RDT methodology will be not be shared with patients or care providers, since they are as of~     yet, unproven.~   "
27384|NCT02698761|"~     Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to~     90,000 individuals in the United States.[10] There are 13,000 hospital admissions for a~     sickle cell crises, costing $448 million dollars annually.[10] In our hospital, the sickle~     cell population is known to have some of the longest length of stays. Between October 2014~     and September 2015, there were 89 admissions for a vaso-occlusive crisis with an average~     length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater~     than 20 days.~      We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to~     determine if pain and length of stay can be reduced in patients with sickle cell disease. We~     also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay~     and help with pain. We hypothesize increased physical activity and proper sleep, as~     implemented in the CPP, are correlated with decreased hospital length of stay and decreased~     pain. Additionally, we believe that creating a standardized nighttime environment at the~     hospital will help the children stay in their circadian rhythm thus promoting improved sleep~     and a more effective inpatient disease management.~   "
27885|NCT02692157|"~     Healthy adult men who abuse opioids and are physically dependent on them will be invited to~     participate in a study to examine the ability of NT-814, a neurokinin (NK) antagonist at the~     1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.~   "
27385|NCT02698748|"~     One of the proposed ideas for malaria elimination includes the use of drugs to interrupt~     malaria transmission by exhausting the human reservoir of infection. Theoretically, mass~     treatment of an entire population with a very effective and rapid-acting drug (for instance~     an ACT), followed by the administration of an effective prophylactic regime during a minimum~     of four weeks, so as to outlast the typical development period of Plasmodium parasites in~     Anopheline mosquitoes, could achieve the same objective. In this respect, chloroquine (CQ)~     would be an appropriate candidate. This drug exhibits two conditions that make it attractive~     for elimination campaigns: 1) It has been demonstrated to have an excellent safety profile,~     allowing for its use in all age groups including pregnant women and children; and 2) Its~     relatively long elimination half life (t1/2=1-2 months) can provide a long post-treatment~     prophylactic effect. Recent evidence suggests that CQ sensitivity may be returning in places~     where discontinuation has reduced the drug pressure to the parasite populations. In~     countries such as Malawi, P. falciparum seems to have regained full sensitivity to CQ, and~     molecular markers of antiCQ resistance have nearly disappeared. While this does not support~     the reintroduction of CQ as first line therapy, it does suggest that, if proven sensitive in~     a given area, it could play a prophylactic role in malaria elimination strategies when used~     in combination with other drugs or tools. Thus, we intend to evaluate the potential role of~     chloroquine in preventing infections during elimination campaigns by performing a~     randomized, single-blind, placebo-controlled trial in asymptomatic Mozambican adults.~      Choosing asymptomatic parasitaemic adult males from a malaria-endemic area as our study~     population introduces limited risks when administering a drug with an uncertain efficacy~     (47% efficacious in 2001-2002). In malaria-endemic areas, this age group has a remarkably~     low risk of developing severe disease (irrespective of clinical symptoms), and it is~     foreseeable that parasitemia may be well tolerated, and in certain cases, spontaneously~     cleared from the individual's blood as a result of the immune system. In the unlikely event~     of any clinical symptomatology appearing throughout the follow-up, individuals will be~     examined by a study clinician and treated immediately with the country's first-line malaria~     treatment (artemether-lumefantrine, Coartem ®).~   "
27386|NCT02698735|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited~     skin disease for which there is only supportive care. RDEB is due to mutations in COL7A1~     gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs)~     mediating epidermal-dermal adherence. Approximately 20% of COL7A1 mutations are nonsense~     mutations leading to premature stop codons and a truncated C7 with diminished function. The~     investigators demonstrated that aminoglycosides such as gentamicin readily induce premature~     termination codon (PTC) read through and produce biologically functional C7 in 22 reported~     COL7A1 nonsense mutations. Importantly, aminoglycoside-induced C7 reversed the abnormal RDEB~     cell phenotype and incorporated into the dermal-epidermal junction. Herein, the~     investigators propose the first clinical trial of gentamicin (topical and intradermal) in~     RDEB patients with nonsense mutations that the investigators have fully characterized. The~     milestones include increased C7 and AFs at the patients' dermal-epidermal junction, improved~     RDEB Disease Activity Score, and absence of significant gentamicin side effects.~   "
27387|NCT02698722|"~     In the United States, it is estimated that there are approximately 630,000 patients who have~     ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies~     have demonstrated that the initiation and timing of dialysis for those with ESRD seem to~     vary widely regionally - confirming the uncertainty of the benefits of chronic dialysis in~     this population~      Pre-dialysis education programs inform patients of all of their options allowing them to~     choose renal replacement therapy that is most consistent with their wishes. Recent evidence~     has supported using different methods of delivering education including videos to complement~     standard clinical care practices to promote informed decision making. This proposed study~     will serve to examine the effectiveness of a dialysis modality video decision support tool~     to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.~   "
27388|NCT02698709|"~     The main purpose of this study is to determine new diagnostic criteria for an eye disease~     called keratoconus.~   "
27389|NCT02698696|"~     This study evaluates the effect of a new cognitive remediation program designed for patients~     suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and~     neural processes. In this double-blind (patient, outcomes assessor) controlled randomized~     trial the investigators compare patients receiving the ECo program for bipolar disorders, to~     patients benefiting from the broadly used cognitive remediation program CRT and to patients~     receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9~     months.~   "
27390|NCT02698683|"~     Participants were classified as normal or malnourished according to anthropometric measures.~     Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte~     count was also recorded on the 1st and 7th days.~   "
27391|NCT02698670|"~     This is an observational, prospective, non-randomized, multicenter, post approval study~     being conducted in the United States, Europe and Asia-Pacific Regions.~   "
27392|NCT02698657|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid~     arthritis (RA) on methotrexate (MTX).~   "
27393|NCT02698644|"~     Is to assess the effectiveness of hysteroscopic tubal application of Iso~     Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy~     approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.~   "
27394|NCT02698631|"~     The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified~     by late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial~     fibrillation (AF) ablation outcomes.~   "
27395|NCT02698618|"~     The purpose of this study is to determine whether Ticagrelor has a protective effect on~     microcirculation during percutaneous coronary interventions in patients with Diabetes~     mellitus type II or in a pre-diabetic status.~   "
27396|NCT02698605|"~     The usability assessment focuses on the actual use of the proposed rehabilitation system to~     clarify issues users would face in actual system operation, thus providing a reference for~     subsequent system improvement.~   "
27397|NCT02698592|"~     The purpose of this study is to determine whether the Thermocool SF ® system is at least as~     effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of~     cavo-tricuspid isthmus dependent atrial flutter.~   "
27398|NCT02698579|"~     This is a multi-center, long-term safety and efficacy follow-up study for subjects with~     cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in Study~     ALD-102.~      After completing Study ALD-102 (approximately 2 years), eligible subjects will be followed~     for an additional 13 years for a total of 15 years post-drug product infusion. No~     investigational drug product will be administered in this study.~   "
27400|NCT02698553|"~     Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In~     China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in~     market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets~     formulation is proposed for marketing approval in China for same indication. Therefore, a~     pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label,~     single-centre and single cycle study to evaluate the pharmacokinetics, safety and~     tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses.~     Approximately 16 males and females Chinese healthy subjects will be enrolled into the study~     to get 12 completed subjects.~   "
27401|NCT02698540|"~     The purpose is to observe the compliance to a high-calorie, high protein peptide-based~     nutritional supplement after 3 months in a malnourished population with impaired~     gastrointestinal tolerance living in nursing homes and as outpatients.~   "
27402|NCT02698527|"~     Objective: To compare pain scores on a visual analogue scale during infiltration of local~     anesthetic for vulvar biopsies between women who are treated with buffered versus non-~     buffered lidocaine~      Hypothesis: Patients treated with buffered lidocaine at the site of vulvar biopsy will have~     lower pain scores on a visual analogue scale during the biopsy.~      Study Design: Double blinded randomized controlled trial~      Population: Women undergoing vulvar biopsy at the Women's Primary Care Center and The~     Program In Women's Oncology Clinic of a non-infectious vulvar lesion.~   "
27403|NCT02698514|"~     The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of~     sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG~     analysis.~   "
27404|NCT02698501|"~     The purpose of this study is to determine whether anti-TSLP will decrease airway~     hyperresponsiveness in patients with asthma already on daily treatment with inhaled~     corticosteroids.~      The investigators expect that airway hyperresponsiveness will decrease after treatment with~     anti-TSLP, and that this happens due to a change in the type of mast cells with in the~     lungs. Also, the investigators expect a decrease in inflammatory cells and mediators~     measured in material from the lungs.~      Half of the participants will receive anti-TSLP (MEDI9929) on top of their regular asthma~     treatment, while the other half will receive placebo on top of their regular asthma~     treatment.~   "
27405|NCT02698488|"~     Identification of the embryo with the highest potential to implant and establish an ongoing~     pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day~     by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The~     optimal scenario is the transfer of a single embryo which gives rise to a singleton~     pregnancy. The current limitations in determination of embryos that have the highest~     implantation potential probably contribute to the low rates of pregnancy during IVF~     treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a~     'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it~     provides a chance to evaluate them from the oocyte stage all the way to the blastocysts~     stage. Hence, in the first era of IVF, there were number of studies that evaluated this~     parameter and associated morphology with IVF success rates. On the other hand, it has been~     previously stated that the slight increase in pregnancy rates during IVF treatment is mostly~     likely a result of better practices in laboratory than morphological evaluation. Due to the~     limitations of morphological evaluation, several researchers have investigated adjunctive~     non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.~      Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples~     needed minimal preparation; analytical analysis was rapid and large amounts of data was~     available. Hence, MS might be a promising approach for metabolomic profiling of embryo~     culture media.~   "
27406|NCT02698475|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric~     participants aged greater than or equal to (>=) 6 through less than (<) 12 years with~     moderate to severe chronic plaque psoriasis~   "
27407|NCT02698462|"~     The aim of this study is to identify more persons with advanced neoplasia in the current~     national CRC screening, by adding data on family history of CRC (using a validated online~     questionnaire) to FIT. In addition, the aim is to identify those persons and their family~     members who should not be participating in a FIT based screening but receive surveillance~     colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection~     without affecting participation, thereby increasing the yield of screening.~   "
27408|NCT02698449|"~     The current study aims to better understand cerebral plasticity mechanisms to optimize~     non-pharmacological rehabilitation approaches for patients with traumatic brain injury.~   "
27409|NCT02696564|"~     A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day~     losartan on the progression of emphysema as measured by quantitative HRCT compared to~     placebo~   "
27410|NCT02698423|"~     The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling~     can be used as a primary screening test for unscreened women.~   "
27411|NCT02698410|"~     The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg~     in combination with Temozolomide in subjects with unresectable advanced neuroendocrine~     tumours of the lung or thymus as Disease Control Rate at 9 months.~   "
27412|NCT02698384|"~     The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor~     size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria~     for starting alternative strategies, and to describe the modalities and the global~     effectiveness of alternative strategies.~   "
27413|NCT02698371|"~     The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one~     Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and~     Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious~     cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United~     States Public Health Services (USPHS) criteria.~      The null hypotheses are:~      H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result~     in similar (no significant differences) clinical (aesthetic, functional and biologic)~     behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE~     and SE-Universal adhesives with SE strategies will result in similar restorations~     (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding~     to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar~     restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs~     DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result~     in similar (no significant differences) clinical (aesthetic, functional and biologic)~     behaviour/performance in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with~     enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar~     restorations (aesthetic, functional and biologic) success rates over 24th month evaluation;~     H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive~     strategy will result in similar restoration retention rates in a period of 24th month~     evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing~     adhesive) with SE or ER adhesive strategies will result in similar (no significant~     differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period~     of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU~     (Light-curing adhesive) with SE or ER adhesive strategies will result in similar~     restorations (aesthetic, functional and biologic) success rates over 24th month evaluation;~     H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE~     or ER adhesive strategies will result in similar restoration retention rates in a period of~     24th month evaluation; H0 - FDI or USPHS criteria evaluation outcomes not differ for the~     same data.~   "
27414|NCT02698358|"~     -  Prospective, single-arm, multi-center registry study~        -  A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion~          criteria will be included.~        -  Patients will be followed clinically for 12 months after the procedure.~        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to~          participating hospital's protocol will be performed at 12 months.~        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12~          months.~        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)~   "
27415|NCT02698345|"~     -  Prospective, multi-center, single-arm registry study~        -  A total of 100 subjects with isolated popliteal artery lesions according to inclusion~          and exclusion criteria will be enrolled.~        -  All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT~          Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with~          drug-eluting balloon is allowed • Patients will be followed clinically for 12 months~          after the procedure.~        -  Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up~          will be performed at 12 months.~   "
27416|NCT02698332|"~     The aim of this study is to investigate the effect of diagnostic algorithm for urinary tract~     infection (UTI) on appropriate prescribing of antibiotics and use of diagnostics for~     patients with symptoms of urinary tract infection consulting their general practitioner.~      70 general practices participating in an observational study regarding UTI are randomized to~     either receiving a diagnostic algorithm or not receiving anything additional.~      The study is observational on the patient level and interventional on the practice level.~   "
27417|NCT02698319|"~     Crowding in the emergency department (ED) is a well documented problem putting patients at~     risk of adverse outcomes. To combat this, most ED's use some form of triage. In the last two~     decades systematic triage or process triage has become the norm in most countries but this~     approach is supported by limited evidence. Our aim is to develop a faster triage model of~     only a few vital parameters, based on a data from a large cohort of unselected ED patients~     and evaluate if such a model combined with a clinical assessment by the ED nurse is inferior~     to existing triage models in a prospective cluster-randomized trial~   "
27418|NCT02698306|"~     The investigators will select 30 patients with symmetrical impaction of third molars,~     according to Pell and Gregory dental impaction classification, who would be submitted to two~     surgical procedures, right and left, and in both surgeries dexamethasone 8 mg was~     administered in the pre-surgery phase, and the use of dexamethasone (12 mg/day) for 3 days~     on one side and diclofenac sodium (150 mg/day) for 3 days on the other side was continued,~     in a randomized, double-blind and cross-over trial so that all patients acted as control of~     themselves (split-mouth). Other drugs used in postoperative period, rescue analgesic and~     antibiotic therapy will be identical for all patients. The analyzed variables will be the~     visual analogue pain scale (VAS), total number of consumed analgesics, swelling and trismus~     (objectively), which were statistically analyzed by means of Student's t-test.~   "
27419|NCT02698293|"~     This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of~     patients with pre-malignant tumors and superficial microinvasive disease of the anal canal~     and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer~     Gliolan orally followed by the administration of red light (629-635 nm) to the tumor from a~     laser. The dose of Gliolan will be 40 mg/kg administered approximately 4-6 hours before~     light administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients~     in each. Patients will be observed for 30 days for the development of DLT. Patients will be~     followed up for 24 months for additional toxicity and efficacy data collection.~   "
27420|NCT02698280|"~     The purpose of this study is to determine whether bevacizumab and nimustine are effective in~     the treatment of recurrent high grade glioma and to explore whether there is any subgroup~     being sensitive to this therapeutic protocol.~   "
27421|NCT02698267|"~     The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4~     inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study~     are to assess the safety and tolerability of BIIB074 when co-administered with a strong~     CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of~     BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).~   "
27422|NCT02698254|"~     The goal of this clinical research study is to test the safety of repeat radiation for brain~     tumors that came back after the first course of radiation. Researchers also want to learn~     how repeat radiation affects your quality of life.~   "
27423|NCT02698241|"~     The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only),~     investigational, feasibility study. The purpose of this study is to characterize safety of~     managing heart failure patients with integrated device diagnostics that have an implanted~     commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).~   "
27424|NCT02698228|"~     The goal of the RAPID study is to fundamentally transform the way serious injuries are~     managed after earthquakes and other disasters by introducing a novel and cost-effective~     method for pain control. The study will enroll patients in the aftermath of a major~     earthquake to determine whether regional anesthesia, either with or without~     ultrasound-guidance, can reduce suffering from lower limb injuries, the most common~     earthquake-related injury, above and beyond the current standard of care for pain control in~     these settings.~   "
27425|NCT02698215|"~     This study is a double-blind, randomized clinical trial using a two group medication design~     consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1~     mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking~     daily smokers who want to quit smoking and reduce drinking.~   "
27426|NCT02698202|"~     Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D~     Digital Mammography only in respect to incidence of advanced cancers (interval and following~     round) and interval cancers.~   "
27427|NCT02698189|"~     This is a study to determine the recommended dose of MK-8628 for further studies in~     participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to~     myelodysplastic syndrome (MDS) and in participants with diffuse large B cell lymphoma~     (DLBCL). The recommended dose will be established by evaluating dose limiting toxicity~     (DLT), safety, tolerability, and early efficacy signals.~   "
27428|NCT02698176|"~     This is a study to determine the recommended dose of MK-8628 (formerly known as OTX015) for~     further studies in participants with advanced nuclear protein in testis (NUT) midline~     carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC),~     or castration-resistant prostate cancer (CRPC). This is a two-part parallel study: Part A~     will establish the recommended dose by evaluating dose limiting toxicity (DLT), safety,~     discontinuation, and early efficacy and Part B will enroll participants with NMC only and~     will evaluate safety and efficacy in this population.~   "
27429|NCT02698163|"~     Non-surgical root canal therapy (RCT) represents a standard of treatment that addresses~     infected pulp tissue in teeth and protects against future infection while preserving the~     tooth for the patient for mainly cosmetic purposes. RCT is offered as the better cosmetic,~     cheaper, and less time intensive treatment option for a patient compared to those of dental~     implantation. Dental implantation is the alternative to RCT, and they are both originally~     offered at the time of the initial consultation. RCT involves non-surgically removing dental~     pulp comprising blood vessels and nerve tissue, decontaminating residually infected tissue,~     and using a filler material to replace the non-surgically created space where the pulp was~     removed. Currently, standard of care treatment for RCT utilizes gutta-percha as the root~     canal filling material. Our research group has previously demonstrated NDGP's improvement in~     tensile strength compared to those of gutta-percha. This research studies a new type of~     filler, gutta-percha modified by the addition of nanodiamond material (NDGP). This is an~     equivalence study of NDGP and standard gutta-percha administration.~   "
27430|NCT02698150|"~     HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients~     with severe functional mitral regurgitation undergoing transcatheter mitral valve~     edge-to-edge repair with the Mitraclip system.~   "
27431|NCT02698137|"~     The investigators will prospectively collect patient and procedure-related data in an~     observational study in order to detect patient and procedure-related risk factors for poor~     outcome (i.e. technical failure of the procedure; procedure-related complications).~      Data will be prospectively reported using standard report forms and patients will be~     followed up to 30 days to detect late-onset complications.~   "
27432|NCT02698124|"~     Prospective multicenter, open-lab el, observational, single arm study of decitabine.~     Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to~     receive and not candidate for intensive induction chemotherapy (iIC)~   "
27433|NCT02698111|"~     The investigators do the clinical trial (patients with metastatic nasopharyngeal carcinoma~     treated with donafenib after failure of standard therapy) to assess safety and efficacy of~     donafenib in patients with metastatic nasopharyngeal carcinoma, progressing after all~     approved standard therapies.~   "
27434|NCT02698098|"~     This observational study compares the health and social outcomes between opioid-dependent~     individuals who are either recently released from a compulsory drug detention center (CDDC)~     or recently discharged from a voluntary treatment center (VTC) providing methadone~     maintenance therapy, in Malaysia.~   "
27435|NCT02698085|"~     Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the~     neuromusculoskeletal system. In the clinical practice a favorable effect is observed in~     patients with carpal tunnel syndrome, but there is no published studies evaluating the~     results os this technique.~      The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in~     symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a~     placebo.~      For this purpose the investigators conduct a randomized controlled trial double-blind~     (patient and examiner). The investigators included patients diagnosed of carpal tunnel~     syndrome (low to moderate intensity) with a neurophysiological test.~      Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the~     other placebo. Both groups receive 5 treatment sessions.~      The variables are measured at the beginning and end of treatment. And also some variables~     are measured before and after each session. Patients who participated in placebo group, when~     the intervention finish the investigators will be given the opportunity to receive the~     actual technique~   "
27436|NCT02698072|"~     This study evaluates the combination of a therapeutic exercise program and dry needling in~     the treatment of knee osteoarthritis in older adults. Half of participants will receive~     therapeutic exercise program and dry needling in combination, while the other half will~     receive the same therapeutic exercise program and sham dry needling.~   "
27437|NCT02698059|"~     This is a post-marketing surveillance study to investigate the efficacy and safety of the~     Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.~   "
27438|NCT02698046|"~     This study is design to evaluate the effectiveness of oral iron therapy in patients with~     heart failure and identify the central and peripheral mechanisms involved in the improvement~     of functional capacity after intervention. The investigation includes subjective and~     objective measures on exercise performance and heart function after intervention, and the~     tolerability of oral iron treatment.~   "
27439|NCT02698033|"~     This protocol is designed to better characterize a sub-population of peanut sensitized~     individuals who may be non-allergic, despite significant sensitization, or who may be~     allergic, but at high threshold doses. By specifically targeting participants who met the~     initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC~     MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut,~     the investigators anticipate that the investigators will identify individuals who have~     become spontaneously tolerant, despite persistent sensitization. The investigators might~     also find that clinical sensitivity persists but only with higher thresholds, or that~     sensitivity has increased (or is variable) since the previous allergen exposure. By~     repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will~     distinguish participants who react only at higher doses from those who were not truly peanut~     allergic, address whether their sensitivity has changed, and have the opportunity to further~     investigate their immune response to peanut allergen.~   "
27440|NCT02698020|"~     An open randomized control trial investigating the delivery of two levels of inspired oxygen~     to newborn infants during general anesthesia.~   "
27463|NCT02697721|"~     The purpose of this study is to examine if a psycho-educational intervention for caregivers~     of patients with dementia will decrease caregiver burden, increase caregiver physical~     activity, and decrease the reporting of behavioral and psychological symptoms of the person~     with dementia.~   "
27441|NCT02698007|"~     Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung~     recognized for many years.~      Since the action takes place in the airways and in light of the use of sedation, when~     performing, the procedure requires caution to keep potent airway and breathing sufficient~     enough.~      Most of the bronchoscopy done without the aid of equipment for advanced airway protection.~     During the operation done monitoring hemodynamics: such as blood pressure, pulse and~     respiratory such as percutaneous oxygen saturation and carbon dioxide.~      Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of~     airway respiratory activity during positive-pressure ventilation.~      Several studies have shown that the use of LMA is a convenient and safe while performing~     bronchoscopy for airways and lungs. However, most of the studies were for certain patient~     groups such as children, immuno-compromised patients.~      Or benefits and safety LMA in front of intubation during bronchoscopy.~      Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients~     undergoing flexible elective bronchoscopy .~      Another objective, to examine whether there is a special group of patients enjoy the LMA~     more than others.~      Patients will be divided randomly into two groups alternately by order, one patient study~     group and the next one to control.~      Study group : LMA is inserted under sedation and used during the procedure.~      Control group - performing bronchoscopy under sedation without LMA.~      About 50 people are needed each group.~   "
27442|NCT02697994|"~     ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33%~     of women, continuous and severe back pain is observed. In management of this pain, sterile~     water injection is considered to be an effective method. Aim of this study is assessment of~     effectiveness and satisfaction of this method among Turkish women in which analgesic methods~     are not extensively used in labour and rates of cesarean section exponentially increases.~      Material and Methods: 168 termed, healthy women who admitted to Istanbul~     Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back~     pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were~     applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th,~     30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for~     epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction~     and breastfeeding scores were assessed.~   "
27443|NCT02697981|"~     Background: Nutrition challenges follow bariatric surgery can intensify during pregnancy and~     may have a crucial effect on fetus. To the best of the investigators knowledge, the effect~     of nutritional counseling on improvement of maternal diet quality and eating habits among~     post- bariatric pregnant women has not been evaluated.~      Objective: study aims to expand the existing limited knowledge in respect to post bariatric~     pregnant women's eating habits and quality of food intake, and to investigate the impact of~     nutrition counseling on these factors.~      Design: This is a controlled clinical trial comparing post Laparoscopic sleeve gastrectomy~     (LSG) pregnant women who received nutritional counseling with age-matched control healthy~     pregnant women. Counseling will focus on improving quality of food consumption, eating~     habits and behavioral changes in order to improve the mother and the fetus' nutritional~     status Nutritional data and eating behavior will be obtained using 24 hours recall dietary~     records and the Family Eating and Activity Habit Questionnaire (FEAHQ).~   "
27444|NCT02697968|"~     Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs~     3 times higher than general population. Conventional approaches for AS have their~     limitation. Previous studies demonstrated acupuncture has significant therapeutic effects~     for AS in diminishing joint pain, enhancing functional disorders and modifying spinal~     deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence~     is very limited due to methodological flaws.~      Design This study will be a single-arm pilot study in patients with AS. Eligible subjects~     will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions~     in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in~     total) if participants request a prolonged treatment. The acupuncturist, who is a registered~     Chinese medicine practitioner, of this trial will not participate in data collection and~     data entry.~      Objective: To explore the treatment effect of electroacupuncture for relieving pain in~     ankylosing spondylitis.~      Setting: Hong Kong~      Participants: 20 subjects with a diagnosis of ankylosing spondylitis~      Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events~      Data analysis All data will be double-entered and checked for consistency before conducting~     the analysis. Binomial test will be used to analyze the percentage of responders to~     treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to~     compare the values of all continuous variables between baseline and post treatment. The~     population for safety analyses will include all subjects who receive at least one~     acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction~     Terminology Dictionary. Special attention will be given to those subjects who have~     discontinued treatment due to adverse events or who experience serious adverse events.~   "
27445|NCT02697955|"~     The study investigates the effect of a ultrasound-guided subsartorial saphenous block on~     postoperative pain following major ankle and hind foot surgery.~   "
27446|NCT02697942|"~     This will be a pilot, single center, randomized, controlled trial to slow cognitive decline~     in adults undergoing hemodialysis (HD). The investigators will test two interventions~     (cognitive training and exercise training) against the standard of care.~   "
27447|NCT02697929|"~     Cirrhotic patients undergoing liver transplantation are at very high risk of post operative~     complication such as post-operative residual curarization.~      Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly~     antagonized with sugammadex.~      No one study compared sugammadex versus neostigmine after rocuronium infusion during liver~     transplantation.~   "
27448|NCT02697916|"~     ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for~     ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81~     mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up~     will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for~     secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The~     primary endpoint is a composite of all-cause death, hospitalization for MI, or~     hospitalization for stroke. The primary safety endpoint is hospitalization for major~     bleeding with an associated blood product transfusion.~   "
27464|NCT02697708|"~     This study is designed to compare the effect of different dietary potassium sources on~     uptake and retention of potassium, as well as to determine the effect of potassium intake on~     blood pressure and acid-base balance. The study will compare three different sources of~     potassium given as a supplement, potatoes or French fries.~   "
27465|NCT02697695|"~     To evaluate the impact of obesity surgery on chronic inflammation.~   "
27449|NCT02697903|"~     From the recent scientific literature in the field of biological response to physical~     exercise, a significant increase in muscle damage, soreness and inflammation were registered~     immediately and even 48 after resistance exercise. In the other hand, from the recent~     scientific literature in the field of nutrition it is well established that Pomegranate~     juice is a potent antioxidant that can help prevent or treat various disease risk factors.~     However, only few studies associated the effect of the pomegranate with the physical~     exercise. To the authors' knowledge, there are no studies investigated the acute and delayed~     effect of pomegranate supplementation in performance and muscle recovery after exercises~     involved muscle of whole body. Therefore, the aim of the present study was to investigate~     the effect of natural Pomegranate juice supplementation on the acute and delayed response of~     muscle soreness and biochemical parameters following weightlifting training session~   "
27450|NCT02697890|"~     The objective of this study is to evaluate clinically and radiographically the effect of~     Mucograft® seal when used for the ridge preservation procedure in combination with Freeze~     Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue~     remodeling after 4 months healing period.~   "
27451|NCT02697877|"~     The aim of this study is to assess whether myocardial perfusion reserve, measured during~     routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has~     prognostic value in predicting adverse cardiovascular events. Myocardial perfusion reserve~     will be measured with CMR by assessing blood flow through the coronary-sinus - the primary~     vein in the heart.~   "
27452|NCT02697864|"~     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted~     for each test and every subject will test all 3 different formulations. After swallowing~     tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14~     days, subjects will take a different formulation of tafamidis and tafamidis blood~     concentrations will be measured periodically for 6 days. After another 14 days, the last~     formulation will be tested in the same way.~   "
27453|NCT02697851|"~     This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and~     microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There~     will be two study arms, who will take the medications in different orders:~      GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for~     14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days~     wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by~     Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total~     duration of the study is 57 days (+screening and follow up visits) and patients will have 3~     intensive pharmacokinetic days on days 14, 35 and 56.~   "
27454|NCT02697838|"~     A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric~     cancer which paclitaxel-resistant.~   "
27455|NCT02697825|"~     This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath~     Diameter in steep trendelenburg position. Both observations will be done in same patient~     over the surgical duration.~   "
27456|NCT02697812|"~     In North America, almost ½ million people undergo coronary artery bypass graft surgery~     annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac~     surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus~     standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of~     chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively.~     The severity of acute post-operative pain will also be measured. Increased retraction time~     reduces forces required, which should translate to reduced nerve/tissue damage. If~     effective, this simple change in practice could be readily implemented with a major impact~     for patients and the health care system overall.~   "
27457|NCT02697799|"~     In a multicenter, randomized clinical trial of attitudes towards research participation, we~     will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment~     strategies for research participation in a large randomized controlled trial comparing two~     types of radiation therapy for non-small cell lung cancer.~   "
27458|NCT02697786|"~     Postoperative brain damage and neuropsychological disorders have been observed in 30 - 80 %~     of patients after heart surgery with the use of cardiopulmonary bypass (CPB).They can~     persist up to a year after cardiac surgery and are associated with increased hospital~     mortality and prolonged intrahospital stay.~      Hypoperfusion,hyperthermia,atrial fibrillation,genetic predisposition and systemic~     inflammatory response associated with CPB have been identified as pathophysiological~     mechanisms.However, some authors consider cerebral embolisation to be the prevalent~     mechanism of intraoperative brain injury after cardiac surgery,as gaseous or solid cerebral~     emboli can cause ischemia, inflammation and edema,consequently causing cerebral infarctions~     usually resulting with stroke,coma,encephalopathy, delirium and cognitive decline.~     Additionally,they may impair cerebrovascular reactivity (CVR).~      Aortic valve replacement (AVR) preformed by full sternotomy is the standard approach in the~     treatment of aortic valve disease. Minimally invasive (MIS) aortic valve replacement has~     been shown to reduce postoperative mortality, morbidity, and pain while providing faster~     recovery, a shorter hospital stay, and better cosmetic results. However, due to technically~     more demanding procedure, MIS may lead to prolonged CPB time and incomplete de-airing of the~     heart with an increased risk for cerebral gas embolization. Therefore, the choice of MIS~     might bear an augmented risk for brain injury.~      Transcranial Doppler (TCD) enables real time detection of intraoperative emboli in the~     cerebral arteries seen as microembolic signals (MES), and is an essential neuromonitoring~     tool. Several studies demonstrated correlation between the number of MES and the occurrence~     as well as severity of postoperative neurological complications. However, the factors~     contributing to brain injury have not been elucidated in those studies. The investigators~     speculate that impairment of CVR is an important mechanism that persists and prolongs the~     duration of brain injury into postoperative period.~      The aim of the study is to compare two surgical approaches used for AVR, with focus on the~     number of MES and their impact on levels of protein S100B (marker of brain tissue~     damage),postoperative CVR and cognitive function With the results,the investigators aim to~     help surgeons in selecting the appropriate technique for AVR in individual participants,as~     well as to clarify the effect of aortic valve surgery on the brain.~   "
27459|NCT02697773|"~     The primary purpose of this study is to evaluate the efficacy of a titration arm of~     tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher~     dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo.~     The study also evaluates the safety of the treatment regimens.~   "
27460|NCT02697760|"~     To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging~     with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart~     disease.~   "
27461|NCT02697747|"~     The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4~     interspace will improve resident's long term skill to correctly identify the interspace as~     compared to palpation alone.~   "
27466|NCT02697682|"~     To investigate the feasibility and short term safety issues of treatment of knee~     osteoarthritis with intra-articular injection with the stromal vascular fraction of~     abdominal adipose tissue (SVF) harvested and prepared using the Lipogems System.~      Hereby we wish to pave the road for a high quality randomized controlled trial investigating~     effectiveness of treatment of knee osteoarthritis with SVF looking at patient reported~     outcome, function, homeostasis of the joint and cartilage regeneration.~   "
27467|NCT02697669|"~     Heart failure is a clinical syndrome of exercise intolerance and/or congestion. The~     potential roles of myocardial perfusion and metabolic abnormalities in subjects with~     cardiovascular risks, metabolic disease and heart failure assessed by nuclear dynamic~     imaging warrant further investigations. The study investigators propose that microvascular~     dysfunction and abnormal metabolic substrate shift precedes and triggers the onset of~     diastolic dysfunctions. The aims are (1) to develop and validate the noninvasive measurement~     of absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) by using dynamic~     imaging with a CZT camera, (2) to assess myocardial glucose metabolism by using 18F-FDG~     dynamic PET, and MBF, MFR and LV systolic and diastolic function by dynamic SPECT~     comprehensively in subjects at cardiovascular risks and metabolic disease, HFrEF and HFpEF,~     (3) to correlate with peripheral serum markers and blood mononuclear cells subsets with~     myocardial perfusion and metabolic abnormalities, and (4) to test the hypothesis of these~     imaging and blood markers in diagnosis and prognostic implications. The study investigators~     also assess myocardial metabolic utilization in healthy and mice model of different~     metabolic disorders (obesity, diabetes mellitus and hypertension) by using 18F-FDG dynamic~     micro PET/CT, as an in-vivo measures which could be used to better understanding the disease~     mechanism and evaluating therapeutic strategies.~   "
27468|NCT02697656|"~     Individual Placement and support (IPS) is an evidence-based approach originally developed to~     help people with severe mental disorders to obtain and maintain employment. The~     effectiveness of IPS for patients with severe mental illness is well documented, but has~     never previously been tested for patients with chronic pain. In fact, employment support is~     rarely provided in pain clinics, despite an increasing focus on integrating work and health~     in all patient treatment (OECD, 2013). The aim of this study is to investigate the~     effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients~     with chronic pain in a hospital outpatient clinic.~   "
27469|NCT02697643|"~     For behavioral health clinicians who are interested in getting tailored treatment and level~     of care recommendations, BH-CDS is a desktop/tablet web-based application that provides~     clinicians with data and a rationale for better decision-making to improve patient care.~      Few Clinical Decision Support (CDS) systems are available for Behavioral Health, and unlike~     existing CDS this product will compile relevant patient data and organize these data into~     general treatment recommendations linked to the patient's presenting circumstances, symptoms~     and substance use issues.~      The BH-CDS solution shall factor patient characteristics into a Latent Class Analysis (LCA)~     that will group patients according to their responses with other patients with similar~     responses (i.e., a subgroup or class). Once patients have been assigned to a class, the~     solution shall present recommendations to counselors that use the software.~   "
27470|NCT02697630|"~     The purpose of this study is to see if the combination of entinostat and pembrolizumab can~     be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has~     spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that~     helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical~     efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic~     uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC)~     inhibitor that has effects on both cancer cells and immune regulatory cells, thus~     potentially enhancing the effects of immunotherapy.~   "
27471|NCT02697591|"~     This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with~     advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine~     the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will~     further evaluate the recommended dose determined in Part 1 in subjects with select tumor~     types.~   "
27472|NCT02697578|"~     In hemodialysis patients, deviations of serum concentration of calcium, phosphate or~     parathyroid hormone from the values recommended by KDIGO are associated to a negative~     outcome. The regulation of calcium, phosphate and parathyroid hormone is complex and each~     parameter is not independently regulated. In hemodialysis patient's simultaneous~     modification in these three parameters are the result of abnormal mineral metabolism and the~     treatment used to correct these abnormalities that usually produce changes in more than one~     parameter. The specific objective of this work is an accurate and exhaustive analysis and~     description of the complex relationships between clinically relevant parameters in chronic~     kidney disease metabolism bone disease. In order to achieve these objectives we have used a~     machine learning approach Random Forest able to extract useful knowledge from a large~     database. The analysis of the complex interactions between the different parameters needs an~     advance mathematical approach such as Random Forest . The second aim of this study is to~     determine whether calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23~     and calcitriol are long-term associated with demographic features, mortality, co-morbidity~     and the therapy prescribed. Compare the predictions obtained with conventional statistical~     analysis versus the new model analysis based on artificial intelligence. Our preliminary~     results suggest that there are interactions between some parameters that are strong enough~     to question whether the evaluation of a given therapy can be based in the measurement of one~     single parameter. Subsequently, we will analyze in a prospective study on incident patients,~     whether the use of this new model may predict the cardiovascular risk and reduce the therapy~     cost.~   "
27492|NCT02697318|"~     The purpose of this project is to demonstrate that there is a new easier method to instill~     eye drops in ones own eye that is as effective as applying a drop directly to their open~     eye. The benefits of this new method include better medication compliance and reduced~     patient anxiety from instilling their eye drops. This secondary benefit should remove the~     approach-avoidance response that prompts some patients to delay or give-up on instilling~     their drops just to avoid the angst and frustration produced by the challenge.~      The new method involves the patient instilling the eye drop onto their closed eyelid and~     then blinking the eye drop into their eye. We aim to show that this method has a similar~     therapeutic effect as the routine administration of an eye drop to an open eye.~   "
27473|NCT02697565|"~     One in four U.S. children under the age of 5 years old are either overweight or obese with~     ethnic-minority children being disproportionately affected. Low-income preschool children,~     many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers~     where daily meals are provided. Nationally, the Quality Rating and Improvement Systems~     (QRIS) organization is responsible for rating the quality of childcare centers. However,~     nutrition and physical activity policy standards have not been incorporated into QRIS~     childcare center policies. Therefore, the goal of this project is to address the 2014 AFRI~     program area priority of Childhood Obesity Prevention by building on the phase I Healthy~     Caregivers, Healthy Children (HC2) NRI/AFRI funded project (2010-2013), in partnership with~     the Miami Dade County Cooperative Extension team, to evaluate the program via~     randomized-controlled trial outcomes, and deliver an evidence-based effective childcare~     center-based program/toolkit. This project (phase II) will expand HC2 Phase I findings by~     transferring the evidence-based HC2 program/toolkit to QRIS childcare centers via a~     train-the-trainers (TTT) model. The following specific aims are proposed; (1) to evaluate~     the TTT model of delivery for the evidence-based HC2 toolkit's effectiveness versus an~     attention control on parent and teacher adoption of healthy lifestyle role modeling~     behaviors, and policy integration; (2) to evaluate the impact of a TTT delivery model versus~     an attention control on child body composition and short- and long-term behavioral health~     outcomes, and (3) to disseminate the HC2 early childhood obesity prevention toolkit TTT~     model within the QRIS early childhood network at the Miami Dade County-level.~   "
27474|NCT02697552|"~     Phase 1, open-label, non-randomized, dose-escalation study to evaluate the safety,~     tolerability, pharmacokinetics (PK), and preliminary efficacy of HBI-8000 administered~     orally.~   "
27475|NCT02697539|"~     This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of~     a microcrystalline zinc-hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in~     periodontitis patients. The investigators hypothesized that mHA precipitates cause delayed~     plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would~     improve periodontal health.~   "
27476|NCT02697526|"~     The aim of the study is to determine differences on radial artery occlusion from two~     compressive methods used after transradial catheterization and its functional impact on hand~     mobility.~   "
27477|NCT02697513|"~     Infection and sepsis are among the leading causes of death worldwide, particularly in~     middle- and low-income countries.The Surviving Sepsis Campaign has launched an initiative to~     improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat'~     Approach. In this prospective before-after study, three interventions will be performed:~     First four months period: collection of baseline data on the clinical management of patients~     with acute infection. Second four months period: During the first days, a 1.5-day focused~     training program will be performed (participants: health care workers of primary care~     facilities within the catchment area of the Gitwe hospital and health care workers of the~     Gitwe hospital). Then, a simple management protocol to care for patients with an acute~     infection will be implemented into clinical practice. During the third four months period, a~     'Sepsis First Aid' kit containing essential resources to treat patients with an acute~     infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary~     care facilities and the emergency department of the Gitwe hospital. During the 8 months~     following the focused training program (periods 2 and 3), data collection will continue. It~     is hypothesized that implementation of a simple clinical management protocol and exposure of~     health care workers in the Gitwe Hospital area to a focused training program on the~     management of acute infections will increase the rate of evidence-based interventions~     performed in patients with an acute infection during the first six hours after hospital~     admission (administration of oxygen and fluids whenever indicated, timely administration of~     antimicrobial drugs, source control measures).~   "
27478|NCT02697500|"~     This study evaluates how blood serum handling conditions can affect the concentrations of~     ~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential~     bias in epidemiologic associations that may result from less than optimal sample handling~     conditions.~   "
27479|NCT02697487|"~     This is a longitudinal observational study (via electronic records and biospecimens)~     designed to utilize health IT advances to collect information from patients undergoing~     routine care. This information will be stored in a database. Patients undergoing routine~     care from their providers will be invited to participate in the UTSW Depression Cohort.~     After obtaining informed consent, the CDRCC team will collect information from available~     sources and store it in a secure UT Southwestern network database protected by a security~     firewall. A schematic representation of this information processing is shown in the figure~     contained in section 3 of the protocol. As part of the UTSW Depression Cohort, patients will~     allow banking of their specimens. Specimens which are banked may include blood or blood~     products, urine, tissue samples, saliva, stool samples or clinical waste products. The study~     will only enroll participants comfortable with providing specimens. As the goal of the UTSW~     Depression Cohort is to create a national database, CDRCC will engage with patients,~     providers, and researchers at local, regional, and national levels. A large number of~     medical providers are already screening patients for depression. Structured instruments like~     PHQ-2 or PHQ-9 are often used. Hence, the CDRCC will seek collaborations with local,~     regional and national partners so that information contained in their health IT initiatives~     can be included in the this database. Due to the clinical nature of information collected,~     the investigators anticipate marked heterogeneity in the variables and amount of data~     collected. Database architects will utilize big data (large volumes of information from~     diverse sources with variable degrees of quality and complexity) tools to structure the~     registry so that additional variables can be added, as needed. The CDRCC team will maintain~     a detailed codebook of variables collected in the database. All statistical analyses will be~     conducted only on de-identified data. Researchers may obtain access to this de-identified~     data by following procedures established by the CDRCC, which include obtaining IRB approval.~   "
27480|NCT02697474|"~     The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of~     age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and~     also evaluate the immune response against hepatitis B one month after vaccination (challenge~     vaccination) with a stand alone monovalent hepatitis B vaccine.~      Primary objectives:~        -  To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after~          last priming dose in subjects having received hepatitis B vaccine at birth and a~          hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during~          A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])~        -  To evaluate the immune response against hepatitis B one month after vaccination with a~          stand alone monovalent hepatitis B vaccine (challenge vaccination).~      Secondary objectives:~        -  To describe serious adverse events (SAEs) reported throughout the trial after~          administration of hepatitis B vaccine.~   "
31696|NCT02642224|"~     Primary outcome: Research participants and their network contacts will be followed over 6~     months to assess whether a social work case management protocol results in reduction of~     trauma services recidivism and criminal violence arrests.~   "
27481|NCT02697461|"~     Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal~     injuries that are a result of inversion injury during sport. The midfoot is frequently~     involved during inversion injury, is often overlooked during clinical examination, and maybe~     contributory to the development of CAI. The purpose of this study is to investigate~     multisegmented foot motion using a motion capture system, clinical joint physiological and~     accessory motion, and morphologic foot measurements in recreationally active men and women~     with and without a history of lateral ankle sprains and chronic ankle instability.~     Additionally, the effects of a joint mobilization intervention in patients with diminished~     multisegmented foot motion and intrinsic foot strengthening in healthy individuals will be~     investigated.~   "
27482|NCT02697448|"~     Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of~     atrial fibrillation~   "
27483|NCT02697435|"~     Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans.~     Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get~     poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic~     Low Back Pain, even though they are often undereducated in the field. These PCPs often use~     advanced imaging, usually MRIs to guide care. These images often show degenerative disc~     disease and other common pathologies in older adults, even those who are pain free, which~     can lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain~     is a syndrome, a final common pathway for the expression of multiple contributors that often~     lie outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety~     could all lessen back pain if addressed and treated probably.~      Investigators will measure participants' low back pain-associated disability with the~     well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The~     investigators hypothesize that veterans who receive PCCET will experience significantly~     greater reduction in low back pain-associated disability than those who receive IAUC at six~     months.~      Investigators will also measure participants' low back pain with the 0-10 Numeric Rating~     Scale for Pain. Data will be collected at baseline and monthly via telephone. The~     investigators hypothesize that veterans who receive PCCET will experience significantly~     greater reduction in low back pain than those who receive IAUC at six months.~      The goal of this study is to compare patients treated with usual care, which usually starts~     with imaging, versus patients who are treated by trained geriatricians who know how to~     recognize and address 11 key conditions that commonly drive pain and disability in older~     adults. The investigators believe that older patients who receive care tailored to their~     needs by educated PCPs will ultimately have less back pain and, more importantly, better~     quality of life.~   "
27484|NCT02697422|"~     The purpose of this study is to test if having a Veteran peer health coach will improve~     blood pressure control among Veterans with high blood pressure and at least one other~     Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health~     messages, discuss goal setting, and action planning around health behavior changes shown to~     decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity,~     and smoking cessation. Facilitators, barriers, and costs of the intervention will be~     determined.~   "
27485|NCT02697409|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents~     in 7th grade of secondary school. The primary endpoint is the change in smoking prevalence~     between the two groups.~   "
27486|NCT02697396|"~     This project aims to raise awareness and improve HPV vaccination rates among children of~     Mexican American parents through the implementation of a tailored social marketing campaign~     which includes text messaging reminders.~   "
27487|NCT02697383|"~     The purpose of this study is to see what effects, good and/or bad, the combination of~     ixazomib and dexamethasone has on the patient and the smoldering multiple myeloma.~   "
27488|NCT02697370|"~     Patients with severe Haemophilia A need prophylactic factor VIII to reduce their risk of~     joint and soft tissue bleeds and to prevent or reduce joint damage. It is common practice to~     give enough factor VIII to maintain the trough level above 1% of normal and this has been~     supported in retrospective studies.~      The amount of factor VIII required to maintain this trough level varies markedly between~     patients because their factor VIII half lives are different. This study will assess the role~     of regular pharmacokinetic (PK)monitoring and dose adjusted factor VIII to establish whether~     this is a more cost effective way of giving treatment and whether it is feasible in routine~     clinical practice. Patients will be treated for 6 months with their standard factor VIII~     regimen and followed up to establish their bleed frequency. They will then receive~     pharmacokinetic adjusted factor VIII to maintain a trough above 1.5% for a year and their~     bleed rate compared to standard treatment. If they have increased break through bleeds their~     factor VIII will be increased to maintain a trough of 3%.~   "
27489|NCT02697357|"~     The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation~     Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include~     partners, family members, children, parents, and friends providing informal care to a~     patient. Providing care to someone with cancer can be difficult. The purpose of this~     intervention is to improve coping and physical well-being among caregivers, which in turn~     will allow them to provide better care for their loved ones. Investigators would also like~     to learn about biological factors like stress that may affect one's emotional and physical~     well-being. This study will allow to better understand caregivers needs, and further develop~     a program to provide services to caregivers within MSKCC community and nationwide.~   "
27490|NCT02697344|"~     This phase I/II trial studies the side effects and best dose of R-(-)-gossypol acetic acid~     when given together with lenalidomide and dexamethasone and to see how well it works in~     treating patients with multiple myeloma, also known as plasma cell myeloma, that has come~     back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol~     acetic acid may stop the growth of cancer cells by recognizing certain proteins and~     stimulating programmed cell death. Lenalidomide may stimulate or suppress the immune system~     in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     R-(-)-gossypol acetic acid with lenalidomide and dexamethasone may work better in treating~     patients with multiple myeloma.~   "
27491|NCT02697331|"~     Aim of the work The aim of this study is to assess the efficacy of the use of vaginal~     progesterone as a method of prevention of preterm labour in twin gestations with short~     cervix .~      Study Design:~      The study is designed as randomized ,placebo-controlled, clinical trial . All women with~     dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out~     patient clinic. Randomization of cases will be done by computer method . 130 women with~     dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm discovered on~     transvaginal sonogram between 20w to 24w gestational age will be enrolled in the study and~     will be distributed in two groups:group P (cases ) and group N (controls) . The~     randomization allocation will be 1 : 1 (vaginal progesterone capsule : placebo).~   "
27493|NCT02697305|"~     Branched chain amino acids (BCAA) are known to exert insulinogenic effect. Whether this~     effect is mediated by incretins (GLP-1, GIP) is not known. The aim of the study was to show~     incretin effect of BCAA, i.e. whether the oral administration of BCAA elicits higher insulin~     and incretin response when compared with IV route of the same dose of BCAA. Eighteen~     healthy, male subjects participated in three tests: IV application of BCAA solution~     (30.7±1.1 g of BCAA, IV BCAA) second was oral ingestion of BCAA capsules in the same dose~     (ORAL BCAA) and third experiment was oral placebo (PLACEBO). Glucose, insulin, GLP-1, GIP,~     valine, leucine and isoleucine levels were measured at time interval for up to 4 h.~   "
27494|NCT02697292|"~     The purpose of this study is to determine whether intravenous immunoglobulin (IVIG)~     treatment reduces significantly the number of epileptic seizures in cases of autoimmune~     epileptic seizures.~   "
27495|NCT02697279|"~     In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous~     abscesses. Traditional incision and drainage (I&D), with or without packing of cutaneous~     abscesses has long been the accepted standard of care. This procedure is often very painful~     for the patient. Additionally, compliance with wound care and follow-up can present barriers~     to proper care and healing. Research has suggested that incision and loop drainage of an~     abscess may be another effective treatment for simple cutaneous abscess. Thus far, research~     into this procedure has been limited to the pediatric population with small sample sizes. In~     these previous studies, this technique was found to be an effective and less painful~     treatment for abscesses. Research has not been done in the adult population using this~     procedure. If this procedure is found to be as effective and less painful in the adult~     population, then it should be considered as a potential preferred I&D method for cutaneous~     abscess in the ED.~   "
27496|NCT02697266|"~     The purpose of the current proposal will be to examine the clinical performance of both~     physicians in training as well as experienced faculty in pre and post call situations.~     Groups will be matched for gender, age, experience and employment duration during regular~     hours versus immediate post call hour.~   "
27497|NCT02697253|"~     The goal of this project is to identify predictors of success in the treatment of obesity~     after roux-en-y bariatric surgery. The specific aims of this proposal are to:~        1. employ behavioral tests of mechanisms that control food intake in normal weight~          individuals, to determine which intake control mechanisms lead to changes after~          Roux-en-y gastric bypass (RYGBP); and~        2. measure behavioral and psycho-social predictors of weight loss and food intake~          reduction, so as to determine which are most predictive of successful weight loss and~          food intake reduction.~      The mechanism investigators propose to account for success is reduction in food intake~     brought about by the pattern of hormone release, particularly glucagon-like peptide-1~     (GLP-1), and gastric distention, both known to underlie satiation, coupled with~     post-ingestive changes in reinforcing value of food and motivation to consume. Tests of the~     hypothesis will be done by measuring responses to tasting, working for, and consuming, foods~     on sensory, motivational, cognitive, and physiological variables, including amount consumed~     and rate of eating under standardized conditions, before surgery and at a two year follow up~     visit. In addition the inhibitor exendin-9-39 (EX9) will be infused before a meal to~     determine whether blockade of GLP-1 Receptor after surgery partially reverses intake~     reduction. Investigators predict that successful patients will show changes that favor~     reduction in food intake, rate of eating, motivation to consume, reward value of foods, and~     a hormone profile that has been shown to generate satiation and maintain reduction in intake~     (e.g. increased Cholecystokinin (CCK), GLP-1, reduced ghrelin). To the extent that~     psycho-social and cognitive factors may override physiological brakes to eating behavior,~     the subjects may fail to achieve success, and consequently the failure may be predicted from~     over-impulsiveness or inability to suppress working for rewarding food stimuli. To test~     these hypotheses, a total of 50 patients will be enrolled prior to RYGBP and restudied 2~     years after the surgery. Based on known high attrition in this population and our past 10~     year experience with bariatric research, it is estimated that 100 patients will need to be~     enrolled over 2 years to obtain 50 who complete testing at 2 years. EX9 studies will be done~     in a subset of 30 completers, only after roux-en-y gastric bypass (RYGBP), 15 failure (<15%~     weight loss) 15 success ( >30% weight loss).~   "
27498|NCT02697240|"~     Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion~     from sickling of red blood cells, that can lead to pain or organ complications such as acute~     chest syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a~     compound important for dilating the blood vessel wall. Citrulline is a substance that is~     known to increase nitric oxide. The goal of this Phase I study are to find the highest safe~     dose of continuous IV citrulline that can be given to individuals with sickle cell disease~     experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side~     effects.~   "
27499|NCT02697227|"~     The goal of this research study is learn if Behavioral Activation Treatment (BATS) or Health~     Education/Smoking Cessation counseling (HE), combined with the nicotine patch, can help~     people with different types of emotion and attention levels quit smoking.~   "
27500|NCT02697214|"~     Over the last two decades, there has been a proliferation of commercially available heart~     rate monitors. Recognizing that elite athletes often use heart rate to monitor training and~     assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring~     systems to the general public. Recently, there has been a move from monitors that rely on~     chest straps to measure electrical activity toward more convenient, wrist-worn monitors that~     employ optical sensing technology similar to that used for pulse oximetry. While the~     accuracy of chest strap monitors has been assessed in a variety of studies, there is no data~     concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors'~     accuracy is important both for the subjects who rely upon these monitors to guide their~     athletic activity and for the physicians to whom these individuals report their heart rate~     readings.~   "
27512|NCT02697058|"~     Study Part 1: To assess the safety and tolerability, and to characterize the~     pharmacokinetics (PK) of BAX2398 in combination with 5-FU/calcium levofolinate in Japanese~     patients.~      Study Part 2: To compare the efficacy of BAX2398 in combination with 5-FU/calcium~     levofolinate versus 5-FU/calcium levofolinate as assessed by Progression Free Survival (PFS)~     using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).~   "
27513|NCT02697045|"~     Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long~     Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient~     Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality~     of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients~   "
27620|NCT02695641|"~     The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose~     bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in~     hemodialysis patients. This information will be used to plan a phase 1 clinical trial~     evaluating bevacizumab's role in hemodialysis vascular access failure.~   "
31697|NCT02642211|"~     Prospective randomized trial in patients requiring cataract surgery in which IOP, angle~     anatomy and other demographic and clinical data are compared. Subjects randomized to both~     MSICS and phakoemulsification~   "
27501|NCT02697201|"~     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells~     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes~     occurs when the cells of the body become resistant to the effects of insulin, and this~     causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and~     the heart. Understanding how insulin resistance occurs will pave the way for new therapies~     aimed at preventing and treating type 2 diabetes.~      Mitochondria are cellular structures that are responsible for turning nutrients from food,~     into the energy that our cells run on. As a result, mitochondria are known as the~     powerhouse of the cell. Mitochondria are dynamic organelles that can move within a cell to~     the areas where they are needed, and can fuse together to form large, string-like, tubular~     networks or divide into small spherical structures. The name of this process is~     mitochondrial dynamics and the process keeps the cells healthy. However, when more food is~     consumed compared to the amount of energy burned, mitochondria may become overloaded and~     dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with~     the ability of insulin to communicate within the cell. This may be a way for the cells to~     prevent further uptake of nutrients until the current supply has been exhausted. However,~     long term overload of the mitochondria may cause blood sugar levels to rise and lead to the~     development of type 2 diabetes.~      This study will provide information about the relationship between mitochondrial dynamics,~     insulin resistance and type 2 diabetes.~   "
27502|NCT02697188|"~     Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE~     and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.~   "
27503|NCT02697175|"~     To assess the effect of live video-colposcopy on women´s anxiety.~   "
27504|NCT02697162|"~     Study design is a prospective, randomised, double-blind, and interventional. Primary aim of~     the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary~     catheters in prevention and reduction of catheter-associated urinary tract infections in~     children with neurogenic bladder. Secondary aim is to assess feasibility of~     antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder~     management. Octenidine chloride will be used as antiseptic.~   "
27505|NCT02697149|"~     Radiation exposure may put endoscopists at risk when performing endoscopic retrograde~     cholangiopancreatography. Although non-radiation endoscopic retrograde~     cholangiopancreatography was reported in pregnant women in previous reports, it remains~     unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe~     when endoscopists were not expose to radiation. This study was to evaluate the effectiveness~     and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in~     patients with complexity level I/II.~   "
27506|NCT02697136|"~     The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs.~     placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid~     vessel wall area as measured by 3TMRI, when administered to patients with familial primary~     hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.~   "
27507|NCT02697123|"~     The purpose of the study is to prospectively assess the prevalence of venous thrombosis in~     women hospitalized for Cesarean Section, vaginal delivery or extended antepartum~     hospitalization by using Compression ultrasound of the entire proximal venous system of the~     lower limb veins.~   "
27508|NCT02697110|"~     Social interaction (in the form of serve and return exchanges) between child and parent are~     crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan~     countries are ill-equipped to maximize the benefits from this interaction. The investigators~     approach builds on the traditional outlook that it takes a village to raise a child i.e.,~     not only the parents but other extended family members play a role as caregivers to young~     children. The investigators intention is to use the existing post-natal/child welfare~     clinics to deliver an intervention, which uses culturally acceptable videos and active~     skills building, to deliver health messages and practical skills to women, with the~     intention that they will subsequently engage and teach their partners and other caregivers~     about early brain stimulation and child development.~   "
27509|NCT02697097|"~     Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.~      To investigate the hip muscle strength in a normal control group and compare this to~     patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and~     with confirmed radiological features).~   "
27510|NCT02697084|"~     Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and~     6% of anorectal cancers. Incidence is less than 1/100 000 of the general population.~     However, the incidence has increased considerably over the past three decades. The main risk~     factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or~     radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy.~     The choice of the most appropriate treatment strategy will condition the patient's~     prognosis. Consequently, early assessment of the initial extension of the tumor, its~     therapeutic response and relapses constitute determining factors in the management of the~     disease Despite the good results obtained, persistent disease is observed in 30% of cases~     and abdominal-pelvic salvage amputation can then prove effective in cases of local or~     loco-regional relapse. The great majority of relapses occur within 2 years after treatment.~     Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and~     inguinal or pelvic lymph node involvement.~      The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses~     principally on the clinical examination although the type and frequency of the paraclinical~     examinations are not backed by any consensus.~   "
27511|NCT02697071|"~     This research study will be a prospective, randomized, double-blind, placebo-controlled~     trial. Because ketamine has yet to be directly studied as treatment for acute migraine~     headache in the emergency department, the research team is initially interested if ketamine~     can reduce pain scores in headache patients and reduce the incidence of recurrence while~     exhibiting an adequate safety profile. By using a placebo-controlled study design, the~     research team can adequately investigate the effectiveness of the medication in a subgroup~     previously not well studied.~   "
27907|NCT02691871|"~     The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750~     mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients~     harboring wild-type EGFR after failure of first line chemotherapy and to determine the~     recommended dose for the Phase II trial.~   "
27514|NCT02697032|"~     Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen~     receptor (AR) presence in metastatic breast cancer patients by means of~     18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to~     predict (early) treatment response to, and optimal dosing of, the anti androgen~     bicalutamide. The ultimate goal is to contribute to optimal selection of breast cancer~     patients for anti androgen treatment. Objective: Feasibility to detect a diffrence in uptake~     on 18F-FDHT scan after 6 weeks of treatment with bicalutamide in metastatic breast cancer~     patients. Secondary Objectives: to describe whether changes in 18F-FDHT tracer uptake after~     six weeks associates with response to bicalutamide, to describe whether changes in AR~     availability are different for breast cancer subgroups during treatment with bicalutamide~     and to describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor~     expression. Study design: This is a single arm, one stage feasibility study, which will be~     executed in the University Medical Center Groningen, The Netherlands. The primary endpoint~     of the study is to evaluate the difference in 18F-FDHT uptake in tumor lesions after 6 weeks~     of bicalutamide treatment in patients with AR-positive metastatic breast cancer. Patients~     will be treated with bicalutamide until progression or unacceptable toxicity is encountered.~     Study population: The investigators will include 20 postmenopausal metastatic breast cancer~     patients with an AR positive, HER2 negative tumor. Patients should be restaged clinically~     with bone scintigraphy and CT scan within a 6 week timeframe of the PET examinations.~     Intervention: All patients will receive a baseline FDHT-PET scan and start with bicalutamide~     treatment 150mg daily. During follow-up patients will receive one FDHT-PET scan after 6~     weeks. Treatment with bicalutamide will continue until progression or unacceptable toxicity~     is encountered. Main study endpoint: The percent difference in 18F-FDHT uptake in tumor~     lesions after 6 weeks of monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT~     uptake after 6 weeks compared to baseline uptake with an α of 0.05 and a power of 80%, is~     considered clinical significant.~   "
27515|NCT02697019|"~     The primary aim is to investigate the effectiveness of an Internet-delivered Emotion~     Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).~   "
27516|NCT02697006|"~     The purpose of this study is to collect prospective safety and performance information for~     the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung~     failure or in high risk percutaneous intervention procedures in catheterization lab.~   "
27517|NCT02696993|"~     There are 2 parts to this research study: Part 1 (dose escalation) and Part 2 (dose~     expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     nivolumab that can be given either with radiation therapy alone or in combination with~     radiation and ipilimumab, in patients with NSCLC. The goal of Part 2 of this study is to~     learn if the dose of nivolumab found in Part 1 when given with radiation therapy and~     ipilimumab can help to control the disease.~   "
27518|NCT02696980|"~     The purpose of this study is to test the effect of increasing lung volume with a simple~     hand-held device to both prevent, and also to relieve, airway constriction in people with~     asthma and a BMI ≥ 35 kg/m2.~      Twenty people with late onset non-allergic asthma and a BMI of ≥ 35 kg/m2 will be recruited.~     The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction~     will be tested. Lung volume will be modulated by breathing out against a small level of~     resistance (positive expiratory pressure).~   "
27519|NCT02696967|"~     The purpose of this study is to determine the safety and tolerability of CLR325 in heart~     failure patients to determine if further clinical development of the drug in this indication~     is warranted.~   "
27520|NCT02696954|"~     Primary Objective~        -  To characterize the potential pharmacokinetic interactions of artemether -lumefantrine,~          amodiaquine and primaquine in healthy adult subjects.~      Secondary Objectives~        -  To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine~          and primaquine when given alone and in combination.~        -  To evaluate the safety and tolerability of co-administered artemether-lumefantrine,~          amodiaquine and primaquine.~        -  To investigate pharmacogenetic polymorphisms affecting drug levels of~          artemether-lumefantrine, amodiaquine and primaquine and their metabolites.~   "
27521|NCT02696941|"~     SGLT2 inhibitors have been proven to be effective in several preclinical rodent models of~     non-alcoholic fatty liver disease (NAFLD). Using a choline deficient diet to recapitulate~     some of the histological features of human non-alcoholic steatohepatitis (NASH), it was~     found that 5 weeks of SGLT2 inhibition led to significant reductions in hepatic triglyceride~     content and improved markers of liver fibrosis. Similarly, 4 weeks of treatment in obese~     mice led to improved glucose tolerance, reduced hepatic steatosis and reduced markers of~     liver oxidative stress in a dose dependent manner. These findings corresponded with an~     improvement in traditional liver function tests including the aminotransferases (ALT and~     AST). The widely used antidiabetic agent metformin has been shown in rodent models to~     increase hepatic insulin sensitivity and lower liver fat content which is in contrast to the~     findings in humans where metformin increases hepatic insulin sensitivity, reduces body~     weight but does not decrease liver fat content. The reason for the discrepancy between the~     animal and human studies, with regards to liver fat content remains unclear.~      The investigators hypothesise the following:~        -  SGLT2 Inhibitors have the potential to decrease lipid accumulation in the liver through~          reduced de novo lipogenesis (DNL)~        -  There will be no decrease in endogenous lipid synthesis (DNL) with metformin and thus~          no change in liver fat content.~      There are two arms to this study.~        -  Arm 1: x10 participants with poorly controlled type 2 Diabetes (T2DM) who have been~          recommended to start an SGLT2 inhibitor called dapagliflozin will be recruited.~        -  Arm 2: x13 participants with insulin resistance who have not yet started any diabetic~          medication will be recruited and will be prescribed metformin at standard clinical~          doses.~      The two arms will run in parallel and all participants will undergo identical investigations~     before and after 3 months of treatment with either dapagliflozin or metformin.~     Investigations will include liver magnetic resonance imaging/spectroscopy, fat biopsy, fat~     microdialysis sampling, two-step hyperinsulinaemic euglycaemic clamp, breath sampling and~     stable glucose and palmitate isotope infusions.~      The investigators aim to show that SGLT2 inhibition decreases liver fat whereas we aim to~     demonstrate why liver fat remains unchanged in humans, treated with metformin. These data~     will provide the first evidence for the use SGLT2 inhibitors in NAFLD, and will be highly~     informative for the design of future clinical studies. Moreover, the data gained from the~     metformin arm of the study will provide the first mechanistic evidence in humans of the~     effects of metformin on hepatic fatty acid metabolism.~   "
27522|NCT02696928|"~     Feasibility of methylene blue-based combination therapy in the radical treatment of adult~     patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial~      Study rationale:~      Elimination has become the goal of malaria programmes in an increasing number of endemic~     countries and regions. Primaquine (PQ) is the only registered drug for radical cure of~     Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and~     resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been~     shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West~     Africa. As there is evidence for MB probably being effective against the hypnozoites of~     Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination~     therapy in Plasmodium vivax malaria.~      Study objectives:~      The main objective of this trial is to study the feasibility of MB-based combination therapy~     in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.~   "
27621|NCT02695628|"~     This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission~     tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in~     imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks~     blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor.~     [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that~     have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET~     scan and this may help researchers learn whether changes occur in the tumors after~     treatment, which can help decide how well the treatment worked earlier than is currently~     possible~   "
27523|NCT02696915|"~     Fracture femur is a common injury which is associated with excruciating pain. Positioning~     for neuraxial blocks is always challenging because even slight overriding of the fracture~     ends is intensely painful .It can causing major patient distress which accompanied by~     well-known physiological sequelae such as sympathetic activation causing tachycardia,~     hypotension, and increased cardiac work that may compromise high-risk cardiac patients.~      Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of~     the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but~     it is also associated with minimal risk as the local anesthetic is injected at a safe~     distance from the femoral artery and femoral nerve. It is always safe to perform the fascia~     iliaca compartment block prior to spinal anesthesia as the patient can respond during~     administration of the local anesthetic and can prevent intra-neuronal injections~   "
27524|NCT02696902|"~     Clinical Trial looking to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically~     Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas~     aeruginosa~   "
27525|NCT02696889|"~     The ROSE study is designed to determine the efficacy of bone marrow derived stem cell~     therapy on ovarian function recovery in subjects with idiopathic and other types of~     premature ovarian failure (POF)~   "
27526|NCT02696876|"~     This is a proof-of-concept study to determine the safety and efficacy of a novel device to~     increase the reparative capacity of the knee. The discovery of a resident population of~     mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this~     reparative cell population having direct access to superficial cartilage and joint~     structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel~     strategy for joint repair. Current arthroscopic procedures result in the removal of all SF~     MSCs due to continuous irrigation throughout the procedure. The current study would benefit~     the patient by greatly increasing the reparative capacity of the joint by bolstering MSC~     numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the~     synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot~     formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the~     marrow and may result in faster, better quality repair.~   "
27527|NCT02696863|"~     The main objective is to identify obstacles and elements facilitating the implementation of~     a tracking device Broncho Pulmonary Cancer during the course of care.~      The secondary objective is to assess patient knowledge and information received on their~     previous occupational exposure during their professional activity.~      This is a prospective multicenter study of qualitative methodology through in-depth~     interviews conducted with patients treated at ICLN and CHU Saint-Etienne~   "
27528|NCT02696850|"~     The goal of this research project is to explore the impact of the addition of budesonide to~     high-volume, low-pressure nasal sinus saline irrigation (aka Neti-Pot-type systems) for~     patients with chronic rhinosinusitis with or without nasal polyps.~   "
27529|NCT02696837|"~     In prospective, safety-control study; children undergoing laparoscopic inguinal hernia~     repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned~     into four groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal~     Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle~     relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart~     from standard monitorization, all patients' intragastric pressures will also be monitored.~     Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric~     pressure, intraabdominal pressure, intraoperative findings and complications will be noted~     and compared between groups.~   "
27530|NCT02696824|"~     The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South~     Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for~     depression and adherence, integrated into the HIV care setting in patients with HIV who did~     not achieve viral suppression from first-line treatment. The CBT treatment will be compared~     to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described~     in study endpoints section below).~   "
27531|NCT02696811|"~     Studies have shown that certain compounds inside vegetables can reduce the risk of cancer.~     Carrots in particular have an association with reduced incidence of colorectal, bladder and~     breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated~     cells that have shown a reduction in cancer cells as well as inflammatory markers which have~     been associated with an increased risk of cancer. These polyacetylenes have not been well~     studied in the human body and it is unclear whether they are able to affect the biomarkers~     of health (disease) including DNA damage and inflammatory markers. The aim of this research~     project is to determine whether eating a portion of white carrots every day for 6 weeks can~     lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6~     weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.~   "
27532|NCT02696798|"~     The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor~     necrosis factor (TNF) inhibitor-experienced participants with radiographic axial~     spondyloarthritis (rad-axSpA).~   "
27533|NCT02696785|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive~     participants with radiographic axial spondyloarthritis (rad-axSpA).~   "
27534|NCT02696772|"~     Long term maintenance of weight loss is generally poor, which is at least partly due to~     increased feelings of hunger associated with restricting what can be eaten. Intermittent~     severe energy restriction is a novel dietary strategy that requires individuals to consume a~     very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted~     on the other days in the week. However, the effect of a consuming a very-low energy diet on~     appetite regulation, which might represent a key marker of long-term adherence to dieting,~     has not been determined. This study aimed to assess the effects of severely restricting~     energy intake for 24 h on markers of appetite regulation, energy balance and metabolism~     compared to an adequate energy trial.~   "
27535|NCT02696759|"~     The purpose of this research is to test whether bacteria that normally live in the~     intestines play a role in fighting cancer. It is believed that the development and behavior~     of these immune cells may be influenced by bacteria and other microorganisms living in the~     gut. In turn, the activities of these immune cells could work with anti-cancer therapies to~     make them more, or less, effective.~   "
27536|NCT02696746|"~     To understand the pathophysiological basis of heritable pain syndromes. This will consist of~     a number of components:~        -  Determine the genetic basis for heritable pain syndromes.~        -  Investigate the pain symptoms, psychological co-morbidity and quality of life in~          patients with heritable pain syndromes.~        -  Use quantitative sensory testing to investigate abnormalities in sensory processing.~        -  Use imaging modalities to investigate the neural correlates of pain perception in~          heritable channelopathies.~        -  In select patients to perform skin biopsy to determine if there has been any damage to~          C-fibres.~        -  To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for~          future studies into the molecular basis of altered pain perception.~        -  To use neurophysiological tests, the axon reflex, and conditioning challenges to~          determine how peripheral nerves, in heritable channelopathies and unusual pain~          syndromes, have been altered.~        -  Microneurographic recordings for directly detecting the function of pain fibres in~          peripheral nerves. Knowledge gained from the study will be used to aid the further~          development of genetic testing and specific pain questionnaires for the diagnosis of~          heritable pain syndromes secondary to channelopathies.~        -  Ultimately better knowledge of underlying pathophysiology in these heritable pain~          conditions may inform the development of novel treatments.~   "
27537|NCT02696733|"~     Obturator nerve block is an effective method to prevent adductor muscles contraction during~     transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal~     anaesthesia the patient does not feel uncomfortable during the blockade and the~     interadductor approach gives the possibility to perform it in the lithotomy position. The~     aim of the study was to evaluate the safety and effectiveness of ultrasound-guided obturator~     nerve identification and blockade for TURBT.~   "
27538|NCT02696720|"~     Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation;~     in particular most persons who undergo limb amputation will experience phantom pain. The~     neuropathic nature of PLP suggests the involvement of both peripheral and central~     neurological mechanisms, including neuroplastic changes in the central nervous system. PLP~     as other central nervous system-related pain syndromes remains a challenge for treatment.~     Scar hyperalgesia involves peripheral mechanisms and results frim the production of~     substances liberated by damaged skin cells. These inflammatory substances lower the pain~     threshold by altering the chemical environment of skin nerve endings. Scan hyperalgesia is~     associated with secondary mechanical hyperalgesia in the skin area around the scar.~      The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of~     peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive~     cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting~     in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of~     lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment~     of symptomatic postherpetic neuralgia. It also has been successfully used in patients with~     other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal~     sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous~     pain. The lidocaine patch has not been studied for the management and prevention of phantom~     limb pain.~      The aim of the present research is to investigate if a lidocaine patch 5% is effective for~     reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent~     peripheral nociceptive input from the stump after surgery may drive maladaptive cortical~     reorganization leading to chronic central pain and thus promote chronic phantom limb pain.~     Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of~     peripheral nociceptive afferents and thus decrease the likelihood of developing persistent~     phantom limb pain.~      This study is designed as a randomized controlled multicentric double blind trial, in which~     the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.~   "
27539|NCT02696707|"~     Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in~     participants with early stage breast cancer, with a 33% decrease in risk of death. However,~     retrospective analyses of participant outcomes in these trials have demonstrated increased~     risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).~      At this time, investigators are unable to predict which participants are at increased risk~     of cardiac-related treatment complications. Currently all patients receive regular cardiac~     imaging throughout their one year of trastuzumab treatment.~      At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains~     unknown, and several published consensus guidelines are currently in use as standard of~     care.~   "
27540|NCT02696694|"~     This study aims to investigate the impact of serum progesterone concentrations on the day of~     embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary~     outcomes, the investigators will investigate if endometrial volume measured by~     three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone~     levels and with chances of pregnancy.~   "
27541|NCT02696681|"~     Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for~     individuals with HIV with various psychological comorbidities, which the investigators call~     syndemics. Syndemics are co-occurring psychosocial problems that interact with each other~     and with health behavior such as HIV sexual transmission risk behavior and adherence to self~     care.~   "
27542|NCT02696668|"~     This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance~     exercise programme on falls risk, balance confidence and quality of life in older adults who~     fall or at risk of falling when implemented in a group setting.~   "
27543|NCT02696655|"~     (i) To develop a behavioural intervention that supports healthcare professionals to~     effectively deliver lifestyle behaviour change of patients undergoing liver transplantation~      (ii) To assess the acceptability and feasibility of the behavioural intervention during~     routine practice~   "
27544|NCT02696642|"~     To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab~     ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or~     renal impairment~   "
27557|NCT02696460|"~     Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A~     common analgesia method is the topical administration of local anesthetics directly onto the~     wound. However, complete wound debridement is often hampered by insufficient analgesia~     leading to interruption of the actual debridement and fragmentation of treatment into more~     frequent serial debridement sessions. Alternatively, the inhalation of an nitrous~     oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the~     investigators have compared the analgesic method of an eutectic mixture of topically~     administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50%~     N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.~   "
27558|NCT02696447|"~     The aim of the present study is to determine the frequency and to identify main risk factors~     for venous thromboembolism of venous thromboembolic complications in a population of cancer~     patients treated with a curative intent by ionizing radiation.~   "
27545|NCT02696629|"~     The prevalence of OSA is 3.5~4.6% in Chinese adults. OSA leads to repetitive hypoxemia,~     hypercapnia, and arousal from sleep and is an independent risk factor for hypertension,~     stroke, coronary artery disease and congestive heart failure. CPAP is the first-line~     treatment for OSA. But many patients do not adhere to therapy.~      The upper airway(UA) anatomical abnormality is a prominent risk factor in Asian OSA~     patients, which might be improved by surgical strategies. However, surgery shows variable~     clinical effectiveness. One important reason for patients responding poorly to single~     treatment procedure is that multiple abnormal physiological traits contribute to OSA.~      High loop gain is one of the key non-anatomical risk factors. It will be useful to~     individualize therapy in OSA by better understanding the reversibility of increased LG, the~     interaction of LG and UA anatomical change as well as the condition that trigger reduction~     of LG.~      The project will test the hypothesis of 1) Elevated LG is induced in some patients and is~     reversible by treatment of OSA; 2) Change of LG is related to the improvement of sleep~     apnea; 3) An elevated LG is related to residual sleep apnea after upper airway surgery,~     which might be eliminated by adjunct CPAP therapy after surgery. The results would improve~     the efficiency of non-CPAP treatment and provide a potential combined treatment option for~     those patients with both elevated loop gain and anatomy risk factors in the Asian~     population.~   "
27546|NCT02696616|"~     Investigation of safety and tolerability of BI 655088 following intravenous infusion of~     single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI~     655088 after single dosing~   "
27547|NCT02696603|"~     The purpose of this study is to understand variation in the symptoms of Parkinson disease.~     This study uses an iPhone app to record these symptoms through questionnaires and sensors.~   "
27548|NCT02696590|"~     This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in~     multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each~     method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level,~     the durability of the response, the practicality and the possible toxicity.~   "
27549|NCT02696577|"~     Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine~     growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine~     growth restriction is diagnosed antenatal; however, some of these fetuses, especially if~     unscreened during pregnancy, may be detected only in the neonatal period. It is very~     important for obstetricians and perinatologists to identify growth restricted fetuses,~     because this fetal condition is associated with significant perinatal morbidity and~     mortality.~      Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon~     atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid~     end, which is considered the beginning of the chain, thus alpha, and the methyl end, which~     is considered the tail of the chain, thus omega. Omega3 improve fetal wellbeing by two~     mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and~     lactation normalizes intrauterine growth restriction induced changes in adipose deposition~     and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation~     increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin~     receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation~     normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic~     function in intrauterine growth restriction~   "
27550|NCT02696551|"~     This is a retrospective and prospective designed study, included hospitals are 1:1 assigned~     into two groups: ①Interventional hospital, which will receive 3-month medical education;~     ②Non-interventional hospital, which will not receive 3-month medical education. During 1~     month before education, all the electronic records of outpatients and inpatients who visit~     the included rheumatologists will be collected and the data of test and evaluation results~     of spondyloarthritis (SpA) patients diagnosed according to new Assessment of~     Spondylo-Arthritis International Society (ASAS) criteria will be collected from outpatient~     electronic records and inpatients medical charts; in the 3 months after education, the same~     data will be collected and compared with the data before education, and the impact of~     medical education on physician behaviour will be analyzed. Meanwhile, the understanding and~     acceptance level will be evaluated by the questionnaire, the differences before and after~     education and the impact of education on physician cognition will be evaluated.~   "
27551|NCT02696538|"~     The purpose of this research study is to investigate how useful three balance tests are in~     predicting fall risk in the individual with traumatic brain injury (TBI). These tests are~     the Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance~     Evaluation Systems Test (mini-BESTest).~   "
27552|NCT02696525|"~     Conduct a prospective study to confirm blood and urine ctDNA detection value in~     non-small-cell lung cancer patients.~   "
27553|NCT02696512|"~     This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention~     protocol in patients with severe disorders of consciousness (SDOC).~   "
27554|NCT02696499|"~     This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2,~     proof-of-concept efficacy and safety study in patients with end-stage renal disease~     requiring hemodialysis.~      The purpose of the study is to determine the efficacy and safety profile of PA101B delivered~     via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic~     despite using standard treatments.~   "
27555|NCT02696486|"~     The purpose of this is to develop and implement a pilot study that will demonstrate the~     ability to recruit, enroll, retain, conduct exercise training, and collect pre and post~     outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity~     in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).~   "
27556|NCT02696473|"~     Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and~     anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether~     the polyacetylenes could have an effect in vivo, this study aims to determine whether they~     are detectible in human biofluids after the consumption of a portion of carrots and whether~     a difference is seen between a large and small portion.~   "
27559|NCT02696434|"~     This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in~     conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from~     buprenorphine maintenance prior to the first dose of VIVITROL.~   "
27560|NCT02696421|"~     Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During~     this month major changes in meal times and patterns, sleeping times and activity occur.~     Starvation is known to lead to a compensatory reduction in energy expenditure. However, the~     Ramadan fast is not synonymous with starvation as it involves intermittent periods of~     fasting followed by gorging. People who fast during Ramadan feel less energetic. However,~     little is known about the effects of this religious practice on energy metabolism. .~      The aim of this study is to assess energy dynamics before and/or after and during Ramadan~     fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food~     (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living~     conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF,~     doubly labeled water will be used to measure TEE and activity monitors will measure physical~     activity. In addition, body composition analysis will be performed by bio-electrical~     impedance. Blood sample will be taken to exclude medical factors affecting energy~     metabolism.~   "
27561|NCT02696408|"~     The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated~     lesions. There are little data in the literature showing its efficacy in prevention of~     mucositis in cohorts of patients with hematopoietic stem cells transplantation.~      The main objective of this study is to assess the efficacy of a prophylactic low level laser~     therapy on the severity of oral mucositis during HSCT.~   "
27562|NCT02696395|"~     Hip replacements are being performed on an increasingly active population, who are likely to~     wear their implants out prematurely. New hip replacements have been devised to minimise the~     risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the~     performance of two established types of hip replacements using Corail and Tri-Lock stems~     along with Deltamotion acetabular component. The primary objective of the trial is to~     compare the long term stability of these two devices.To do this, the study will use an~     advanced 3D Xray technique to detect migration of the components at 3 years. The study will~     also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported~     outcome measures and change in bone density.This study is being conducted at a single site,~     at the Nuffield Orthopaedic Centre, Oxford.~   "
27563|NCT02696382|"~     The investigators plan to test an innovative, home-based, short duration, high intensity~     exercise program designed for application in the immediate post-hospitalization period in~     older Veterans. Preliminary data suggest a more intensive approach to physical therapy in~     older adults after hospitalization is safe and maximizes mobility more than usual care. The~     Veterans participating in the high intensity exercise program will receive therapy utilizing~     higher resistance exercises. Outcomes from this group will be compared to data collected~     from the patients receiving standard, lower resistance therapies.~   "
27564|NCT02696369|"~     This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with~     different epinephrine concentration in patients undergoing surgical extraction of impacted~     lower third molars~   "
27565|NCT02696356|"~     This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the~     GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the~     body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201~     consists of 4 different peptides (small parts of proteins) that are expressed by melanoma~     cells. The intent of treatment with GRN-1201 is to increase your body's immune response to~     melanoma.~      To further increase your body's immune response against tumor cells, the GRN-1201 vaccine~     will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as~     sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and~     increase the response against the tumor cells. This is a phase I study which means that this~     will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be~     tested in a small number of people to evaluate its safety, find a safe dose, and identify~     side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF~     dose will remain the same.~   "
27566|NCT02696343|"~     Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via~     orosensory entrainment (NTrainer) device technology and serial salivary gene expression~     analyses, will be merged to examine the relation between gene expression, oral somatosensory~     stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age~     (CA) on 180 extremely preterm infants [EPIs] (< 28 weeks gestational age (GA)) enrolled at~     three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth~     (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San~     Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment~     groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD).~     We hypothesize that the combination of the NTrainer® intervention for improved oral feeding~     skills, along with objective salivary gene expression data to monitor response to treatment~     and feeding development, will result in a novel, objective, and personalized approach to~     neonatal oral feeding and reduce the duration of time to attain oral feeds while improving~     feeding, growth and neurodevelopmental outcomes at 18 months' CA.~   "
27567|NCT02696330|"~     Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI~   "
27568|NCT02696317|"~     The purpose of this study is to evaluate the performance of two commercially-available~     silicone hydrogel contact lenses in normal and low humidity environments after at least 7~     days of wear.~   "
27579|NCT02696174|"~     This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and~     effectiveness of a health microinsurance scheme in improving health equity and clinical~     outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post,~     quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and~     normal OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed~     households to access a defined benefit package at a selected PPC for treatment and~     follow-up.~   "
27622|NCT02695615|"~     We investigated a correlation between maternal anxiety and age, body mass index (BMI),~     parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to~     emergent or elective C/S under general anesthesia.~   "
28033|NCT02690194|"~     The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing~     the stress and anxiety levels of patients. The secondary aim is to investigate the effect of~     prior stress and anxiety levels on the perceived pain level of undergoing a medical~     procedure, reported post-procedure.~   "
27569|NCT02696304|"~     Along with the improvement of childhood acute leukemia treatment, survival rates have~     increased. Therefore, the number of long term childhood leukemia survivors has increased~     progressively over the last decades. So, the assessment of long term health status in this~     population becomes very important. Many studies have shown an increased risk of life~     threatening late complications and early mortality. Cardiovascular morbidity and mortality~     are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an~     important concern since it is associated with cardiovascular morbidity and mortality. The~     overall MS prevalence in the French prospective cohort of survivors of childhood acute~     leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia~     treatment. Since the median age at MS evaluation was 21 years, this prevalence was very~     high. Anyway, the MS pathophysiology in this population is still poorly understood. One of~     the most recent hypothesis about the MS mechanism is based on the adipose tissue inability~     to store fatty acids: when adipose tissue cannot expanse further to store excess nutriments~     then lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin~     resistance and MS.~      The investigators hypothesized that the adipose tissue could be damaged by treatments~     received during childhood acute leukemia treatment (particularly TBI). This leads to~     morphological and functional abnormalities that could promote the insulin resistance and MS.~      This ectopic adipose tissue contains less preadipocytes, which could impair its functional~     properties.~      The primary endpoint of this study is to compare the morphological and functional~     characteristics of adipose tissue in patients with a MS who received or not TBI during~     childhood leukemia treatment . This comparison will focus on:~        -  The adipose tissue repartition and evaluation of the ectopic adipose tissue~        -  Fibrosis and inflammation of the adipose tissue~        -  Preadipocytes quantification~      The secondary endpoint is to describe:~        -  for the whole cohort of included patients,~        -  the clinical and biological characteristics associated with the MS.~        -  Cardiovascular risk factors and nutritional statement~        -  Anthropometric measurements~        -  Detection of other endocrinal abnormalities possibly associated with the MS~        -  Analysis of inflammation blood markers and adipokines quantification.~   "
27570|NCT02696291|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral~     solution when administered to healthy subjects three times a day (TID) for 7 days.~   "
27571|NCT02696278|"~     The goal of this study is to examine the effect of increasing children's intake of fiber and~     unsaturated fat, through daily servings of hummus and vegetables, on their microbiome~     profile.~   "
27572|NCT02696265|"~     Objective: The purpose of this study is to compare the efficacy and safety of complex~     fractionated atrial electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation~     based ablation in patients with persistent atrial fibrillation (AF).~      Hypothesis: CFAE guided ablation will increase atrial fibrillation free survival compared to~     a PVI guided ablation.~      Patient population: Patients with persistent atrial fibrillation will be randomized based on~     a 2:1 ratio into one of two study arms:~        -  CFAE guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus~          rhythm during ablation, according to methods by Nademanee9. PVI will be checked before~          and after ablation using a mapping catheter~        -  PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter~          control of pulmonary vein signals~   "
27573|NCT02696252|"~     Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an~     Automated Applicator vs. a Manual Sensor Applicator~   "
27574|NCT02696239|"~     The purpose of this study is to evaluate the impact of implementing different types of~     suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic~     hysterectomy on cost, operative time and post operative surgical outcomes.~   "
27575|NCT02696226|"~     This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve~     Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the~     incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation~     on the incidence of reduced leaflet motion.~   "
27576|NCT02696213|"~     Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel,~     community-based, client-centred intervention where skills training is incorporated into~     social activities that users want to perform. The trainer also offers problem solving~     strategies to help manage environmental barriers and to promote social participation. This~     intervention is different from customary scooter training in that customary training is~     often very limited and focuses on learning discrete skills outside of the user's normal~     environment. The purpose of this study is to explore the feasibility of conducting a~     mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which~     will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be~     strong enough to support the conduct of a subsequent multi-site trial with a sufficient~     sample size to enable us to quantify definitive outcomes such as adverse events (e.g.,~     injuries and abandonment).~   "
27577|NCT02696200|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). An externally-worn medical device that applies mild jugular compression according to~     the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that~     the Device has the potential to reduce the likelihood of TBI. The currently developed collar~     has been approved for studies in humans and the results indicate safety for use during high~     demand and maximal exertion activities, This study will investigate the effectiveness of~     this device in high school athletes playing a collision sport such as football. The use of~     helmets during such a high-risk sport will allow for collision measurement devices to be~     embedded in the helmet and will not affect play or fit of equipment. Athletes participating~     in this study will be randomly assigned to one of two groups: 1) Device wearing during the~     season or 2) Non-device wearing during the season. The helmets of all participants will be~     outfitted with an accelerometer which will measure the magnitude of every impact to the head~     sustained by the athlete. Effectiveness of the device will be determined via differences in~     longitudinal brain imaging and functional testing following competitive football~     participation. A subset of athletes who report a diagnosed concussion will also receive~     additional brain neuroanatomical and neurophysiological testing within a week following the~     diagnosed concussive event. The purpose of the study is to monitor longitudinal changes in~     brain structure and function between the preseason and postseason, in a population of~     football playing athletes wearing the Device and compared to a similar population not~     wearing the device. Secondly, the purpose is to determine the protection of the device~     relative to amount and magnitude of sustained head impacts.~   "
27578|NCT02696187|"~     This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based~     system directed towards two target groups; people with chronic obstructive pulmonary disease~     (COPD) and health professionals in primary care. KOL-webben include tools that improve~     health literacy with a specific focus on 1) increased physical activity and 2) use of~     appropriate self-management strategies. Moreover, KOL-webben include knowledge and tools~     directed towards staff in the primary care aimed to implement provision of evidence based~     health promotion interventions.The feasibility and effects of KOL-webben will be evaluated.~   "
27580|NCT02696161|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other~     progressive disease, CTS is characterized by remission and recurrence. Although many~     conservative managements of CTS, the effectiveness of these methods is insignificant or only~     persist for a short duration. The platelet rich plasma (PRP) is a new and potential~     treatment for patients with kinds of musculoskeletal disorders and recent reports showed~     being beneficial for peripheral neuropathy in animal studies. Since 2014, two small clinical~     trials showed the positive effect of PRP in peripheral neuropathy. One study shown the PRP~     has therapeutic effect for peripheral neuropathy in patients with leprosy. In addition, PRP~     having protective effect against neurological deficit of facial nerve during superficial~     parotidectomy. However, these studies have not entirely proved the effects of PRP on~     peripheral neuropathy because these studies enrolled small number of patients and lacked~     controlled design. In addition, the PRP was not used for treating CTS so far. The~     investigators design a randomized, double-blind, controlled trail to assess the effect after~     ultrasound-guided PRP injection in patients with CTS.~   "
27581|NCT02696148|"~     This trial is conducted in the United States of America. The aim of this trial is to~     investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the~     body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide~     in obese children aged 7 to 11 years.~   "
27582|NCT02696135|"~     Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with~     a prevalence of ∼0.2%. The disease affects all age groups, with marked clinical~     heterogeneity, ranging from a normal life span without symptoms to poor outcomes such as~     sudden cardiac death (SCD), advanced heart failure, or stroke.~   "
27583|NCT02696122|"~     Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair,~     including local anesthesia, regional and general. Even though local anesthesia is a more~     cost effective anesthetic technique for such procedure, spinal anesthesia remain a popular~     anesthetic technique. Traditionally, anesthesia and surgery studies have assessed outcomes~     such as time to wake or hospital stay and the incidence of nausea, vomiting, pain or other~     adverse events. Recently, a measurement that probes quality of life from the perspective of~     the patient has been considered as a more important factor in clinical studies that wish to~     investigate the effect of anesthesia and surgery on patient recovery and satisfaction. There~     are no recent data on the application of a validated questionnaire to assess which~     anesthetic technique, local infiltration under general anesthesia via laryngeal mask or~     spinal anesthesia, would provide better quality of recovery in the opinion of the patients~     undergoing inguinal hernia repair. The aim of the study is to perform a randomized clinical~     trial comparing the quality of recovery (Quality of Recovery - 40) after local infiltration~     under general anesthesia via laryngeal mask or spinal anesthesia for unilateral inguinal~     hernia repair. METHODS - Seventy patients aged 18 to 65 years old, with an ASA physical~     status I or II, who were scheduled to undergo local infiltration under general anesthesia~     via laryngeal mask or spinal anesthesia for unilateral inguinal hernia repair at Santa~     Lucinda Hospital will be enrolled in the study. The anesthesia was performed according to~     the following sequence: L Group - intravenous (I.V.) propofol and alfentanyl, followed by~     laryngeal mask airway (LMA) positioning. The anesthesia will be maintained by propofol. For~     local anesthesia, approximately 50 ml of 0.5% ropivacaine will infiltrated along the line of~     incision in the subcutaneous plane, followed by peripheral nerve block technique (e.g.,~     ilioinguinal-hypogastric nerve block) and local wound infiltration at the fascial level. S~     Group - spinal puncture followed by intrathecal 15 mg of 0.5% hyperbaric bupivacaine~     injection and sedation with propofol by continuous infusion necessary to reach level 5 on~     Ramsay Sedation Scale. After the end of surgery, all patients will be transferred to the~     post-anesthesia care unit (PACU). Pain will be assessed every 15 minutes using a 0-10~     numeric pain rating scale and I.V. morphine will be administered to maintain the pain score~     below 4. The QoR-40 will be administered by a blind investigator 24 hours after surgery.~   "
27584|NCT02696109|"~     The purpose of this study is exploring a theoretically guided intervention, Cornerstone,~     which provides system 'boundary-spanning' services, including therapeutic services and~     mentorship, to transition-age youth with mental disorders. Cornerstone is designed to~     improve mental health service engagement and outcomes. The study uses a mixed methods~     approach to refine Cornerstone, and a hybrid design examining feasibility, acceptability,~     and preliminary impact with a randomized trial, alongside implementation.~   "
27585|NCT02696096|"~     This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain~     activity and behavior associated with decision-making about rewards (DD task), working~     memory and working memory cognitive persistence (WM task), and craving (CR task) in 72~     opiate dependent participants initiating buprenorphine. While stably using opiates (initial~     study appointment) and again during withdrawal (approximately 3 days later), participants~     will receive an FMRI scan with behavioral challenges; immediately after the second FMRI,~     they will receive their first dose of buprenorphine. Buprenorphine treatment will continue~     for twelve weeks, followed by a four week taper. Urine toxicological analysis will be~     performed prior to the first scanning session, weekly for two weeks and biweekly thereafter.~      Participation for all individuals will last 4 months. Assessments will occur at baseline,~     and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the~     second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8~     and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16~     weeks will include a taper).~   "
27586|NCT02696083|"~     To investigate the effect of PEMF treatment when administered twice daily over a 90-day~     period by looking at synovial fluid in subjects with osteoarthritis of the knee.~   "
27587|NCT02696070|"~     This study is designed to evaluate the effectiveness of the Provant Therapy System in~     improving localized nerve growth and skin perfusion in subjects with painful peripheral~     diabetic neuropathy of the foot.~   "
27588|NCT02696057|"~     Identification of the effects of spinal stabilization exercises and manual therapy methods~     on pain, function and quality of life in individuals with low back pain.~   "
27589|NCT02696044|"~     The aim of this study is to evaluate the safety and tolerability of triheptanoin in~     participants with Rett syndrome using laboratory values, electrocardiogram, rate of adverse~     events (AE), and physical exam.This study also seeks to evaluate the efficacy of UX007~     (triheptanoin) in improving overall seizure frequency and dystonia.~   "
27590|NCT02696031|"~     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to~     placebo in patients with non-radiographic axial spondyloarthritis at Week 16 as well as week~     52 and long term efficacy and safety up to Week 104.~   "
27591|NCT02696018|"~     Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on~     respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been~     introduced in the clinical practice to evaluate diaphragmatic function. In particular, the~     investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography.~     The aim of this study was to compare the diaphragmatic displacement with traditional weaning~     parameters in potentially ready to be extubated patients undergoing a spontaneous breathing~     trial (SBT).~   "
27592|NCT02696005|"~     30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac~     Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements~     will be taken on the first visit.~      After completion of 3-month Rehabilitation Programme the second set of labs and Echo~     measurements will be taken.~      Than participants will be divided for 2 groups: the patients who wish to continue~     Rehabilitation programme for additional 3-month period and the second group that prefer to~     stop Rehabilitation programme after completion of the first 3 month period.~      For both groups additional set of labs will be taken this time and at the end of the study.~      The Aim of the study: to investigate association between serum KLOTHO level, physical~     activity and possible correlation with laboratory and echocardiographic parameters in cohort~     of Heart Failure patients.~   "
27593|NCT02695992|"~     The RATAF II study is a randomized, prospective, parallel group study, designed to compare~     the effects of two different drug regimens for rate control in permanent AF (atrial~     fibrillation). We will investigate on the difference in effects on exercise capacity,~     biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart~     rate, echocardiographic measurements and symptoms.~      Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem~     will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with~     the beta blocker metoprolol in permanent AF.~   "
27594|NCT02695979|"~     Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic~     liver transplantation.~   "
27595|NCT02695966|"~     This is a single-centre, prospective, non-randomised research study. The research team will~     investigate the feasibility of assessing primary human pancreatic tissue for changes to T~     lymphocyte function and localisation in the presence and absence of AMD3100.~   "
27596|NCT02695953|"~     Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The~     purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity~     changes related to PTSD dysfunction and recovery before and after treatment with Cognitive~     Processing Therapy.~   "
27597|NCT02695940|"~     This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g~     in the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6~     weeks, and the efficacy and safety will be compared with the treatment of LEO 124249~     ointment vehicle.~   "
27598|NCT02695927|"~     This project is designed to test a lightweight, portable, computerized pair of glasses that~     will help reduce some of the cognitive deficits seen in patients who have suffered damage to~     their right cerebral hemisphere.~   "
27599|NCT02695914|"~     The purpose of this study is to observe inflammatory markers like TNF (tumor necrosis~     factor), IL-1 (interleukin-1), IL-6 (interleukin-6),TREM-1 (triggering receptor expressed on~     myeloid cells-1), etc, in patient of FUO with excess-heat syndrome and the influence of~     Compound Qingre Granule on the inflammatory markers.~   "
27600|NCT02695901|"~     Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis~     and reducing biofilm formation, the side effects of a long-term use are unpleasant for~     patients. Melaleuca alternifolia oil has been considered as an alternative because of its~     anti-inflammatory properties. However, little is know about the efficacy of its~     nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine~     (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm~     formation in plaque-free and plaque-covered teeth surfaces.~   "
27601|NCT02695888|"~     This research study examines the feasibility of using an in-vehicle mobile technology~     monitoring system to measure teen secondary task engagement during on-road driving as the~     outcome measure for a web-based intervention to prevent risky driving in novice teen~     drivers.~   "
27602|NCT02695875|"~     Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability~     to those who suffer it. Currently, other treatment resources are being implemented, such as~     aquatic therapy. This therapy seems to provide positive results in different dimensions of~     fibromyalgia.~      The main objective of the study is to determine the effectiveness of a physical therapy~     program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction~     and improvement balance at the end of treatment and a month and a half later (follow-up).~      The type of study is a randomized controlled opened trial. The sample is composed of 34~     women with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2~     groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will~     have two primary outcomes: Pain and balance. The intensity of pain will be assessed using~     the visual analog scale (VAS) and the pain threshold for each one of the 18 tender points~     will be assessed using a electronic algometer. Static balance will be evaluated with the~     Romberg's test and the dynamic balance with the Timed Up & Go test (TUG) and Berg Balance~     Scale. Both type of balance will be recorded in slow motion and then, will be analysed with~     a motion software. Secondary outcomes are: The impact of fibromyalgia on patient's lives,~     that will be measured with the Revised Fibromyalgia Impact Questionnaire (FIQR); the sleep~     quality, that will be assessed with the Pittsburgh Sleep Quality Index (PSQI); the~     fatigue, that will be evaluated witn the Multidimensional Fatigue Inventory (MFI); the~     physical capacity, that will be measured with the six minute walk test (SMWT) and~     confidence in balance that will be assessed with the Activities-specific Balance~     Confidence scale (ABC).~      Each intervention will last one hour and will be made 3 times a week for three months . It~     will consist of 4 sections: Warming, exercises for static and dynamic balance training,~     stretching and relaxation. Statistical analysis will be made using the Statistical Package~     for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the~     significance level set for all analysis.~   "
27603|NCT02695862|"~     The study is single centered; prospective, parallel arm randomized controlled trial.The~     patients will be who presented to Institute of Liver & Biliary Sciences with esophageal~     variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be~     managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac~     rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked~     every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum~     creatinine will checked daily. Packed red blood cells will be transfused to maintain target~     Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of~     terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received~     prophylactic antibiotics; antibiotics will be stopped if there will no other indication to~     continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial~     hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be~     randomly assigned into Group -A (Bolus terlipressin at 1mg every 4hourly) and Group-B~     (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices~     . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline,~     12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG~     (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will~     be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will~     continue Terlipressin for 48 hours.~   "
27605|NCT02695836|"~     This project will evaluate three different strategies to get research findings back to~     managers of care units in nursing homes. Feedback will be provided in a timely and effective~     way so that it results in improvements in organizational context (modifiable features of the~     care unit work environment, such as Formal Interactions, Informal Interactions, Social~     Capital or Slack Time), quality of care providers' work life (e.g., burnout, job~     satisfaction, general health) and quality of care. Three feedback packages will be tested to~     determine the strategy that is most effective at fostering improvements and is also~     cost-effective. The project will be carried out in nursing homes in Alberta and British~     Columbia. The information developed will contribute to better care for Canadian seniors who~     spend their final years in a nursing home.~   "
27606|NCT02695823|"~     Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain~     physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may~     occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault.~     In addition, intracranial hypertension measured with invasive methods has been described in~     certain phases of LT, especially at the time of reperfusion.~      The invasive monitoring of the intracranial pressure is not used in these patients, due to a~     high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure~     has been widely developed in recent years : transcranial doppler and recently ultrasound of~     the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.~   "
27607|NCT02695810|"~     The overall objective is to compare the short-term (3 months) effectiveness of three~     glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose~     variability, body composition, and cardiometabolic risk factors in overweight or obese~     individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).~   "
27608|NCT02695797|"~     The purpose of the study is to investigate effect of immunotherapy in intractable~     cryptogenic epilepsy patients with autoimmune antibody.~   "
27609|NCT02695784|"~     The influence of the preterm gut microbiota in health and disease has been well established.~     However, relatively little is known about how the microbiome changes after discharge and its~     relationship with growth, health and disease outcomes in the preterm population. This study~     aims to follow a cohort of preterm infants and explore the relationship of the later~     microbiome ('after discharge') with later growth and health outcomes in infancy. The study~     will also explore the effect of timing of stopping routinely administered probiotics on the~     post-discharge microbiome, infant feeding and outcomes such as colic.~      The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who~     have also taken part in the investigators microbiome study during their NICU stay (SERVIS~     REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The~     investigators will collect stool at and beyond the time of anticipated discharge (beyond 34~     weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge~     timing of these infants varies, and is usually latest in the most immature infants, allowing~     an assessment of the influence of physical location (NICU vs home) as well as increasing~     age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial~     colonisation of the gut and measure infant weight, length and head circumference at each~     time point. The investigators will use a parent questionnaire to assess daily crying time,~     parents' perceptions of colic severity using a visual analogue scale as well as vomiting and~     constipation for the two weeks before sampling.~   "
27610|NCT02695771|"~     To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single~     intraoperative instillation in preventing recurrence of bladder cancer.~   "
27611|NCT02695758|"~     A non-blinded randomized controlled trial, in which participants undergoing primary reverse~     or total shoulder arthroplasty are randomly assigned to one of two treatment groups.~   "
27612|NCT02695745|"~     The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in~     primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and~     mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by~     UVB (ultraviolet B) irradiation and topical capsaicin.~   "
27613|NCT02695732|"~     To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary~     Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.~   "
27614|NCT02695719|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of~     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
27615|NCT02695706|"~     The measured product in this research is a product for topical use, Laboratoires~     Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the~     improvement in skin hydration as measured by self perception of participant research and~     clinical evaluation and improvement in local microcirculation, assessed by instrumental~     measurements in feet of the study participants.~   "
27616|NCT02695693|"~     Computer assisted interventions are becoming very popular as an intervention strategy for~     students with autism. There is little data on how effective they are or how their~     implementation affects teachers' use of other evidence-based practices. The proposed study~     would be the first to examine these questions in a community setting.~   "
27617|NCT02695680|"~     Real-time optical surface monitoring data will be acquired from 44 human patients with~     primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our~     institution). A patient-specific 4D model will be developed using the raw 4DCT projections~     time-correlated with real-time surface monitoring. In addition, before delivering each dose~     fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image~     acquisitions, time-correlated with optical surface monitoring. The acquisitions will be~     distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.~   "
27618|NCT02695667|"~     Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the~     clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive,~     and CPAP Responsive~   "
27619|NCT02695654|"~     Adductor canal block has become popular as effective mean for pain relief following knee~     surgery.This block has not been checked in chronic pain patients.The purpose of this study~     is to assess the efficacy and safety of adductor canal block on chronic knee pain in~     patients with knee osteoarthritis.~   "
27623|NCT02695602|"~     This is a prospective, patient blinded, randomized, clinical trial enrolling patients with~     symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose~     of this study is to compare two different surgical methods, both of which are already in~     common use, for the treatment of nasal obstruction in patients with inferior turbinate~     hypertrophy.~   "
27624|NCT02695576|"~     Title and abstract~      1 a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.~      A randomized study.~      1 b. Structured summary:~      Authors: B. Nyström, B. Schillberg, E. Svensson, T. Stiles.~      Corresponding author: Bo Nyström, Clinic of Spinal Surgery, Strängnäs, Sweden. e-mail~     address: pgbo.nystrom@gmail.com~      Background: At present there is no clear evidence that surgical treatment by fusion~     operation is more advisable than non-surgical treatment in patients suffering from~     unspecific chronic low back pain (CLBP). By personal experience a subgroup among the CLBP~     patients is selected, possibly representing patients with pain from a motion segment/disc,~     thus making patient selection more specified. Furthermore, selection of level to fuse based~     on radiological findings has not been found reliable. Therefore a mechanical provocation~     test has been developed at the clinic. The aim of this randomized study was to compare the~     outcomes in pain and pain related functions perceived by this specific subgroup of CLBP~     patients following fusion surgery with those following non-surgical treatment.~      Methods: Patients with a specified symptomatology and specified clinical signs at~     examination were recruited and randomized to either type of treatment, non-surgical (NS)~     including cognitive-behavioral therapy and physiotherapy (37 pat.) or surgical (S),~     including the same cognitive-behavioral therapy and physiotherapy as in the NS group plus~     fusion surgery (37 pat.). All patients were thoroughly investigated before start of the~     study and at follow-up one year after treatment. The outcomes perceived by the patients were~     assessed on the validated questionnaires Oswestry Disability Index (ODI), Roland-Morris,~     Balanced Inventory for Spinal Disorders (BIS), Short-Form-36 (SF-36) and Euro-Quol (EQ-5D).~   "
27625|NCT02695563|"~     The aim of the study is to evaluate the effect of vaginal lactoferrin administration on~     amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two~     groups of patients will be prospectively enrolled: not treated with lactoferrin and treated~     with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.~   "
27626|NCT02695550|"~     This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive~     non-small cell lung cancer.~      The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707~     is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.~   "
27627|NCT02695537|"~     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various~     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating~     debilitating, drug-resistant epilepsy.~   "
27628|NCT02695524|"~     This study evaluate the effectiveness of adding neuromuscular exercises with tactile, visual~     and auditory feedback to a strengthening exercises protocol, both emphasizing the~     periscapular muscles on improvement of disability in patients with shoulder impingement~     compared to patients receiving only strengthening exercise protocol.~   "
27629|NCT02695511|"~     The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure~     whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in~     normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and~     sleeping) will be measured in a respiratory chamber. Other measures include the activities~     of the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA,~     organ size by MRI and echocardiography, and posture allocation (time spent engaging in~     different activities and the energy expended during these activities), and activity~     temperament (the innate predilection for movement). This set of studies will allow~     assessment of whether the previously observed metabolic adaptation in response to 25%~     caloric restriction is long lasting (up to two years), associated with reduced thyroid and~     sympathetic activities and reduced oxidative damage. The studies of organ sizes (liver,~     spleen, kidney, heart, adipose and muscle) by MRI and echo (heart) is essential to determine~     whether the metabolic adaptation is related to decreased organ sizes or improved organ~     energy metabolism efficiency. The above described measures will be performed at baseline and~     after 1 and 2 years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI-~     and age- matched subjects who will not engage in caloric restriction.~   "
27630|NCT02695498|"~     Although many adults with migraines use non-pharmacological treatment options, there is a~     lack of research on the use of many mind/body techniques specifically for headache. This~     research will further the understanding of the mechanisms, efficacy, and predictors of~     mind-body practices in adults with migraines.~   "
27631|NCT02695485|"~     A retrospective study is conducted with 151 patients who has a soft tissue defect of digit~     treated with the sensate flaps from February 2005 to March 2014. Based on the different~     regions of soft tissue defects, the patients in the study are divided into four groups: (1)~     thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal~     finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal~     finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region~     group treated with Litter flap. The main outcomes are static 2-point discrimination and~     Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.~   "
27632|NCT02695472|"~     The study will consist of a screening period and a randomized treatment. Approximately 220~     subjects who meet eligibility during the screening period will be randomized to initiate a~     12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams~     twice per day), NSI-189 40 milligrams once a day, or placebo.~   "
27707|NCT02694471|"~     This investigation aimed to compare the response of older adult and young men to 14 day~     bed-rest and subsequent 28 day rehabilitation. Sixteen older (OM: 55-65 years) and seven~     young men (YM: 18-30 years) were exposed to 14-day bed rest (BR) followed by 14-day~     rehabilitation (R), and 400-day of R. Quadriceps muscle volume, force and explosive power of~     leg extensors, single fiber isometric force, peak aerobic power, gait stride length, and~     several metabolic were measured before and after BR and after R.~   "
28034|NCT02690181|"~     The objective of this extension study is the initial assessment of safety and immunogenicity~     of the second dose of GBS Trivalent Vaccine following the time interval that is close to the~     inter-pregnancy interval observed in the general population.~   "
27633|NCT02695459|"~     Phase II, open-label, multicentre national study. Patients with metastatic neuroendocrine~     carcinomas of extrapulmonary origin will be eligible. Treatment will be performed as~     indicated in the section Investigational drug and reference therapy. Cisplatinum and~     everolimus dosing is based upon earlier phase 1 studies (Fury et al. 2012). CTs will be done~     at 9 weekly intervals (after 3 courses of chemotherapy;). Patients will be treated until~     documented progression according to RECIST 1.1. Enrolment is expected to take between 14 -~     16 months. The total study duration is estimated to be 2 to 3 years until publication. Three~     NET centres in The Netherlands will participate, (Erasmus Medical Center in Rotterdam,~     Netherlands Cancer Institute in Amsterdam and , the University Medical Center of Groningen)~     A pre-treatment (and optional post-treatment) tumour biopsy will be included for DNA/RNA~     analyses and organoid culture. An additional 5cc of blood will be withdrawn as a germline~     DNA reference. A second 5 cc of blood will be included for measuring circulating tumour~     transcripts to identify all types of GEP-NET (NETTest).~   "
27634|NCT02695446|"~     The primary objective of this study is to evaluate the skin and plasma concentrations of~     minocycline in subjects undergoing treatment of acne vulgaris with oral extended release~     minocycline. Acne lesion counts and safety/tolerance of the treatment will also be~     evaluated.~   "
27635|NCT02695433|"~     The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days /~     week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate~     control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda~     composite index of insulin sensitivity (MISI).~   "
27636|NCT02695420|"~     - To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart~     failure (HF) with reduced ejection fraction; - To evaluate the safety and tolerability of~     oral omecamtiv mecarbil~   "
27637|NCT02695407|"~     Cardiac output monitoring devices are commonly used in ICU patients. The most precise use~     direct measurement, which require artery cannulation. The gold standard is Swan-Ganz~     catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output)~     is the alternative way of haemodynamic monitoring. This technology is the easy, less~     invasive and cost-efficient tool for determining the main hemodynamic parameters of~     critically ill patients. It is based on two physical principles - transpulmonary~     thermodilution and pulse contour analysis. Both principles allow the calculation of~     haemodynamic parameters in critically ill patients. PiCCO method requires peripheral artery~     cannulation.~      Cannulation may be followed by artery stenosis.~      Aims of the study are:~        1. to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO~          cannula in place.~        2. whether 5 days cannulation of radial artery with PiCCO catheter is related to more~          frequent stenosis rate.~      An additional assessment:~      1. to check whether the eventual stenosis is still present after 3, 14 and 30 days after~     decannulation - assessment depending on patients availability~   "
27638|NCT02695394|"~     The aim of this prospective non-interventional neuropsychological one visit study involving~     functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple~     Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.~      In different experiments, the modulation of cognitive and motor responses by visual~     emotional information and the ability to discriminate visual emotional stimuli will be~     tested using experimental behavioral paradigms. Furthermore, functional connectivity and -~     using fMRI - activations of brain regions known to be involved with emotional processing~     will be evaluated.~   "
27639|NCT02695381|"~     This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one~     time daily when compared with placebo in the treatment of acute Delayed Onset Muscle~     Soreness (DOMS) of the upper limbs.~   "
27640|NCT02695368|"~     The study is a multicenter, double-blind, randomized, controlled trial conducted at three~     major university and teaching hospitals with a catchment population of approximately 1~     million. In the current study it has been hypothesized that a non-invasive air cleaner~     utilizing a plasma chamber can significantly reduce the incidence of surgical site~     infections (SSIs).~   "
27641|NCT02695355|"~     The purpose of this study was to see if the clinical outcome of stimulant medication~     (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on~     the bases of changes in Event Related Potentials (ERPs) induced by a single dose of~     stimulant medication. (ERPs are extracted from electroencephalographic (EEG) registrations~     during the performance of an attention task).~   "
27642|NCT02695342|"~     There is a growing body of evidence demonstrating that older adults with COPD have important~     problems with their balance and a high incidence of falls compared to those of a similar~     age. This research will explore the feasibility and preliminary effects of a tailored~     6-month home balance exercise program for reducing falls in older adults with COPD.~   "
27643|NCT02695329|"~     Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms~     of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial~     alignment compared to conventional instruments~   "
27644|NCT02695316|"~     The aim of this study is to describe access and communication barriers of migrant women who~     do not speak the local language in the Swiss maternity care service provision from the~     perspective of users, health care professionals and interpreters.~   "
27645|NCT02695303|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
27646|NCT02695290|"~     There is a medical need for improving treatment of poor performance status patients with~     EGFR driver mutations and documenting safety and tolerability of existing agents.~   "
27647|NCT02695277|"~     This is a prospective, randomized (2:1) multicenter trial to investigate the optimal~     treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF)~     ablation.The study objective is to compare the efficacy and safety of two interventional~     approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with~     persistent or longstanding persistent atrial fibrillation.~   "
27648|NCT02695264|"~     The purpose of this study is to prospectively evaluate the accuracy and safety of~     non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000)~     device compared to the current invasive external ventricular device (EVD) or parenchymal~     (bolt) monitoring devices in the pediatric population.~   "
27649|NCT02695251|"~     Renal functional reserve is defined as the glomerular hyper filtration induced by a protein~     load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a~     protein load. Renal functional reserve loss is associated with a persistent hyper filtration~     state, seen in first stages of diabetic nephropathy, leading to progression of Chronic~     Kidney Disease (CKD). This observation has lead to larger clinical studies that demonstrated~     the positive effects of protein restriction on kidney function, and allowed the scientific~     community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD~     progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and~     metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that~     renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation~     End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the~     demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat),~     were in fact responsible for an AGEs load, based on recent published data.~      The aim of this study is to determine whether AGEs alone or proteins in general are~     responsible for the mobilization of renal functional reserve, leading to the progression of~     CKD.~   "
27650|NCT02695238|"~     Superiority multicenter prospective randomized study on operative delivery (instrumental~     delivery or caesarean section) of prophylactic manual rotation in case of persistent~     occipital posterior presentation during the second stage of labor compared to expectant~     management. A 15% reduction of operative delivery (instrumental delivery or caesarean~     section) is attempt in the prophylactic manual rotation group.~   "
27651|NCT02695225|"~     Tobacco use remains a significant public health problem and is increasingly prevalent among~     vulnerable groups. Appalachians have a high prevalence of tobacco use and are at increased~     risk for tobacco-attributable diseases. The efficacy of a scientifically valid tobacco~     cessation treatment delivered to Appalachian smokers remains untested. Also, little is known~     about the association of social-contextual factors that may modify or mediate the success of~     an intervention. These factors may be of particular relevance among disadvantaged smokers.~     Geographical patterns of tobacco exposure may also influence one's ability to quit,~     especially in pro- tobacco regions like Appalachia. The purposes of this application are to:~     1) evaluate the efficacy of a lay-led (LL) intervention in promoting long term abstinence~     from tobacco; and 2) examine the association between 12 month abstinence and selected~     individual, interpersonal, organizational, neighborhood and community, and societal factors~     among adult Appalachian tobacco users exposed to a tobacco cessation intervention. A third~     aim is exploratory and includes the characterization of activity patterns using space-time~     measures among adult Appalachian tobacco users exposed to a tobacco cessation intervention.~     Using a group randomized trial design, 707 Appalachian residents from 6 intervention and 6~     control counties will be randomly assigned by county to receive the LL intervention or a~     control condition which includes proactive telephone counseling via the Ohio Quit Line. LL~     group participants will receive face-to-face counseling, supervised by a county health~     department nurse, and delivered by a trained lay educator. A county Extension agent will~     assist with recruitment and retention efforts in this project. Social-contextual factors~     will be assessed at a baseline interview administered to all participants. Space-time~     activity geographical patterns of pro- and anti-tobacco exposures, or features, will be~     described among selected participants in four counties during weeks 1, 6 and 12 of~     treatment. At end of treatment and 6 and 12 months, LL and control group participants will~     be reassessed for tobacco use via self-report and cotinine-validation. Secondary analyses~     will explore differential trends over time between the two arms of the study. In a subset of~     the sample, pro- and anti-tobacco exposures will be estimated during weeks 1, 6 and 12 of~     treatment.~   "
27652|NCT02695212|"~     The primary objective of this study is to evaluate the safety and efficacy of Apremilast in~     subjects with moderate Hidradenitis Suppurativa (HS).~   "
27653|NCT02695199|"~     To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic~     varicocelectomy (LV) and compare the surgical outcomes and complications between LDU~     assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with~     varicoceles.~   "
27654|NCT02695186|"~     Intestinal metaplasia is generally considered a precancerous lesion. Although it is~     associated with a very small increase of gastric cancer risk, European Endoscopic Society~     and other European academic companies highlighted the increased risk of cancer in patients~     with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia.~      The production of ROS in the gastrointestinal tract (GI) and their role in the~     pathophysiology and pathogenesis of gastrointestinal diseases have not been studied~     sufficiently. In the plasma of patients, in the context of the sequence gastro oesophageal~     reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous~     formation of DNA adducts and increased myeloperoxidase concentration, which are associated~     with oxidative stress, decreased antioxidant capacity (decreased glutathione~     concentration).These findings support the role of oxidative stress in the pathogenesis and~     malignant transformation.~      Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state~     associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and~     plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the~     pro thrombotic markers, which are associated with increased risk for cardiovascular disease~     and DM2, represent only a part of the relationship between IM and cardiovascular mortality.~      Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such~     patients may increase the risk for developing symptoms and related chronic diseases such as~     DM2. Although the exact contribution of oxidative stress on every pathologic condition~     included in MS is difficult to determine definitively, it is certain that oxidative stress~     is particularly high in the MS.~      Regarding the relationship between MS and GI diseases, studies have reported that patients~     with MS are almost twice at risk for developing Barrett's esophagus.The relationship between~     MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well~     designed prospective studies. It seems however, to be a correlation between obesity and~     GERD, as well as between obesity and gastric adenocarcinoma~   "
27655|NCT02695173|"~     The objective of this study is to compare, by insulin use at the index date, the~     sex-specific incidence of hospitalization or emergency department (ED) visit for severe~     complications of urinary tract infections (UTI), defined as pyelonephritis and urosepsis,~     among patients with type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with~     those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose~     cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or~     sulfonylurea monotherapy.~   "
27656|NCT02695160|"~     The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen~     and activity levels of ascending doses of SB-FIX. SB-FIX is an intravenously delivered Zinc~     Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the~     Factor 9 gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic~     production of the Factor IX clotting factor.~   "
27657|NCT02695147|"~     A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or~     direct aortic approach between January 2011 and January 2016~   "
27708|NCT02694458|"~     Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric~     therapy. The relationship between exposure to vancomycin and efficacy is admitted but~     because of an important intersubject variability, therapeutic exposure isn't usually~     achieved.~      The primary aim of this randomized controlled trial is to evaluate a new early dosage~     adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.~      Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic~     exposure to vancomycin.~      The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach~     will allow patients to achieve the vancomycin pharmacological target faster than with the~     usual treatment strategy.~   "
27658|NCT02695134|"~     The purpose of the investigators proposed randomized, controlled study is to examine the~     effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event~     patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the~     Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a~     waiting period of 3 weeks, or sometimes more, before starting the program.~      Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome~     measures of METs, BMI, physical and mental well-being, and attendance in this population.~      New participants in the CR program who qualify and agree to participate in the study will be~     consented and randomly assigned to the Intervention Group who will receive Healing Touch~     therapy, or to the Control Group, which will not receive HT.~      At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health~     Surveys. The questionnaires will be repeated at the end of the 3 week study period and at~     the end of the 3 months SCIM CR program.~      An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence~     level, and using a two-tailed test, it was determined that a sample size of 56 patients in~     each group would be needed for between group comparisons. To account for potential attrition~     the study will enroll 124 subjects, 62 in each group.~      Our rationale is that Healing Touch, in addition to standard medical care will reduce~     post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab~     program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire.~     Further, the investigators suggest that Healing Touch treatments will improve patient's~     final outcomes of the 12 week CR program.~   "
27659|NCT02695121|"~     The primary objectives of this study are (1) to compare the incidence of breast cancer, by~     insulin use at cohort entry, among females with type 2 diabetes who are new users of~     dapagliflozin and females who are new users of antidiabetic drugs (ADs) in classes other~     than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy and (2) to compare the incidence of bladder cancer,~     by insulin use at cohort entry and pioglitazone use, among male and female patients with~     type 2 diabetes who are new users of dapagliflozin and those who are new users of ADs in~     classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or~     sulfonylurea monotherapy. Secondary objectives will compare, by insulin use at cohort entry,~     frequency of several measures of health care use, baseline characteristics, and incidence of~     selected other cancers in males and females between the two exposure cohorts.~   "
27660|NCT02695108|"~     Neck pain is a very common problem in the population. Most of the patients suffer from neck~     pain for long time and the problem becomes chronic. The investigators studied the effects of~     scapular stabilization exercise on mechanical neck pain.~   "
27661|NCT02695095|"~     To compare, by insulin use at the index date, the incidence of hospitalization for acute~     liver injury (ALI) among patients with type 2 diabetes mellitus who are new users of~     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than~     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy.~   "
27662|NCT02695082|"~     To compare, by insulin use at the index date, the incidence of hospitalization for acute~     kidney injury (AKI) among patients with type 2 diabetes mellitus who are new users of~     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than~     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy.~   "
27663|NCT02695069|"~     The purpose of this study is to assess the efficacy of random placenta margin incision for~     hemorrhage control during cesarean section of complete placenta previa pregnancies.~   "
27664|NCT02695043|"~     The primary purpose of this research is to increase adherence to outpatient rehabilitation~     of chronically underserved individuals with traumatic brain injury (TBI). The intervention~     will be a TBI rehabilitation-focused education tool suitable for use with a wide variety of~     patients, including those with poor literacy skills and those with Limited English~     Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program~     for TBI (MMEPT).~   "
27665|NCT02695030|"~     The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for~     use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck~     greater than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular~     aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and~     less than or equal to 4.5mm.~   "
27666|NCT02695017|"~     The investigator will proceed to assess changes in oxygenation of muscle tissue,~     electromyographic activation and strength in healthy subjects. For this, a measurement of~     all demographic variables on the first day of the study as well as a familiarity with the~     equipment will be performed. Participants will start the intervention 48 hours later to~     proceed with the first intervention with one of the exercises in this research (inertial~     pulley or regular machine). Later on, 48 hours later participants will perform the latest~     intervention that has not yet done, thus generating a crossover study.~   "
27667|NCT02695004|"~     This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy~     male volunteers.~   "
27668|NCT02694991|"~     Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is~     very important as it reduces the risk of postoperative complications.~      However, the contraindications and side effects of analgesic drugs may induce physicians to~     use them so cautiously that pain may actually be under-treated.~      The aim of this open label, controlled study is to assess whether osteopathic manipulative~     treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.~   "
27669|NCT02694978|"~     To evaluate the safety of 1.020 g of IV ferumoxytol compared to 1.500 g of IV Ferric~     Carboxymaltose (FCM).~   "
27670|NCT02694965|"~     Purpose of the study:~      The investigators are proposing that melanomas which respond and develop eventual disease~     stability in response to checkpoint inhibitor immunotherapy undergo a genetic program~     promoting secondary resistance.~   "
27671|NCT02694952|"~     Interventional, individually randomized, double (e.g. investigator and participant) blinded,~     parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared~     to FAV-Africa for the treatment of snakebite with envenoming.~   "
27709|NCT02694445|"~     The purpose of the study is to estimate the Chinese economic burden in patients with~     Alzheimer's Disease (AD).~   "
27672|NCT02694939|"~     The proposed study evaluates the effectiveness of a family-based psychosocial treatment~     program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be~     delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that~     was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process.~     STAND consists of ten 50-minute sessions delivered by therapists with community-typical~     levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and~     efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms~     and indices of academic and family impairment. In the proposed study, 240 adolescents with~     ADHD who present for treatment at one of four community mental health agencies in Miami-Dade~     County, FL will be randomly assigned to STAND or agency usual care (UC). Participating~     agency therapists also will be randomly assigned to deliver STAND or UC. STAND therapists~     will receive a comprehensive treatment manual, three-day training, and weekly supervision~     from a project psychologist. Participants will be screened by research staff in the~     community setting and enrolled on a rolling basis over 30 months. Participants will be~     assessed at baseline, post-treatment, and three-month follow-up. In line with RDoC,~     multi-method measures will be obtained for treatment outcome (family and academic~     impairment), treatment mediators (executive functioning, parent academic involvement,~     parent-teen communication, parent/adolescent motivation, ADHD symptoms), and moderators of~     effectiveness (patient, practitioner, service delivery, and organization characteristics).~     Additional consumer perspective (satisfaction, therapeutic alliance) and agency fit~     (therapist competence, treatment fidelity, need for additional treatment, attendance,~     therapist attitude toward treatment, cost effectiveness) measures will also be obtained to~     evaluate effectiveness. We will recruit an ethnically diverse sample (65% Hispanic, 19%~     African-American, 16% Non-Hispanic White) that is historically underrepresented in research,~     but ideal for evaluating therapy effectiveness.~   "
27673|NCT02694926|"~     Even under established replacement therapy, patients with adrenal insufficiency still suffer~     from impaired quality of life and experience adrenal crises. Patient education is regarded~     as important preventive measure. In this study a german-wide standardized education~     Programme will be evaluated.~   "
27674|NCT02694913|"~     This is a non-interventional, R01-funded pilot study that will identify serum and cellular~     markers in patients' blood samples that can be used as short-term biomarkers of rituximab~     response. We hypothesize that serum complement levels, activation of natural killer cells,~     and clearance of peripheral B-cells will be accurate biomarkers of rituximab response, and~     may be correlated with long-term outcomes.~   "
27675|NCT02694900|"~     The objective of this pilot study was to compare the manual chest compressions (CC) versus~     CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric~     cardiopulmonary resuscitation~   "
27676|NCT02694887|"~     The objective of the present project is to study the accuracy of capillary blood level~     measured by handheld lactate analyzers when compared with the reference methods~     e.g.venepuncture blood gas analyzer sample.~   "
27677|NCT02694874|"~     Even with optimal anti-malaria therapy and supportive care, severe and cerebral malaria are~     associated with a 10-30% mortality rate and neurocognitive deficits in up to 33% of~     survivors. Adjunctive therapies that modify host immune-pathological processes may further~     improve outcome over that possible with anti-malarials alone. Investigators aim to evaluate~     a PPARγ agonist ( rosiglitazone) as adjunctive therapy for severe malaria.~   "
27678|NCT02694861|"~     The purpose of this study it to collect real world 30-day and 1-year follow-up data for~     patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole~     therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.~      The primary objective of this study is to provide ongoing clinical data regarding the~     characteristics of the patient population undergoing TMR in community practices. Secondary~     objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and~     benefit of sustained improvement in angina at 30-days and 1-year.~      The study includes two patient populations:~        -  Registry Group: Patients from selected centers who previously participated in the~          ANGINA RELIEF Registry and are eligible for a one-year, prospective follow-up;~        -  Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected~          centers.~   "
27679|NCT02694848|"~     To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate~     injection based on the population pharmacokinetics and TEG.A prospective, multicenter,~     randomized, controlled clinical trial is used.A total of 120 patients will be recruited and~     will be divided into three groups,respectively salvianolate injection group,aspirin group~     and salvianolate injection and aspirin group，and the course of treatment is 10 days.~   "
27680|NCT02694822|"~     This is an open-label, Phase 1, multicenter study to evaluate the safety, PK, and PD of an~     anti-CTLA-4 human monoclonal antibody (AGEN1884) and to estimate the MTD in subjects with~     advanced or refractory cancer. The study will consist of a 3+3 dose escalation cohort~     starting at a near minimally anticipated biologic effect level (MABEL) dose followed by an~     MTD expansion cohort of immunotherapy-experienced and immunotherapy-naïve subjects.~   "
27681|NCT02694809|"~     The main purpose of this study is to determine if taking the study drug, conjugated~     estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the~     breast tissue of the study subjects. The study drug is approved by the US Food and Drug~     Administration in healthy postmenopausal women to treat certain symptoms of menopause such~     as hot flashes. Since it is not approved in women with DCIS, its use in this study is~     experimental. This study will also look at whether taking the study drug causes any~     significant or undesirable side effects in women with DCIS. The researchers hope that this~     study will help them determine if taking the study drug is safe in women taking DCIS and if~     it can possibly reduce the risk of developing breast cancer in women with DCIS.~   "
27682|NCT02694796|"~     The purpose of this study is to evaluate the impact of an intervention combining a workshop~     during a balneotherapy and the use after the end of the balneotherapy of a web and~     smartphone-based physical activity program using connected devices, on physical activity~     level among patients 12 months after they participated in a balneotherapy in thermal care~     center.~      A multi center randomized controlled trial is setting to evaluate the impact of the~     intervention on physical activity recommendations achievement of the patients.~      Investigators hypothesize that an intervention including a workshop during a balneotherapy~     and an automated physical activity program using web, mobile phone and connected devices~     will help patients to be engaged in more physical activities and to reach physical activity~     recommendations.~   "
27710|NCT02694432|"~     This pilot study will evaluate the feasibility of adding an online mind-body-behavior~     program to an existing behavioral self-management support platform that has been modified to~     promote achievement of blood pressure goals.~   "
27711|NCT02694419|"~     The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few~     attentions. There is a lack of evidence to whether the BMI affects the endometrial blood~     flow, which is necessary for implantation.~   "
27683|NCT02694783|"~     Background:~      Progressive Multifocal Leukoencephalopathy (PML) is a brain infection in people with a~     weakened immune system. Researchers think polyoma virus specific T cells (PyVST) therapy can~     treat PML. The PyVST cells are made from blood cells of a healthy relative. They are grown~     in a lab to expand the virus-killing cells, then given to the person with PML.~      Objective:~      To test whether PyVST safely treats PML.~      Eligibility:~        -  Adults ages 18 and older with PML~        -  Healthy adults ages 18 and older who have:~             -  Been screened under protocol 97-H-0041~             -  A sibling, parent, or child with PML and matching cells~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~        -  PML participants will also be screened with:~             -  Cerebrospinal fluid removed by needle in the back.~             -  MRI: A dye is injected in a vein. They lie on a table that slides into a cylinder.~             -  Questionnaires~      Healthy participants will have apheresis: Blood flows through a needle in one arm into~     machine that separates blood cells needed for donation. The rest of the blood is returned by~     needle to the other arm. Some participants may have a central line placed in a vein instead.~     They can have apheresis up to 3 times, at least 28 days apart.~      Participants with PML will receive the PyVST cells by needle in the arm. They will stay in~     the hospital 1 week. They can do this up to 3 times, at least 28 days apart. After each~     infusion, they will have weekly visits for 1 month. Then they will have 4 visits over 1~     year. Visits include repeats of screening tests.~   "
27684|NCT02694770|"~     This study is to assess the efficacy of Neihulizumab versus conventional therapy and to~     evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute~     Graft-vs-Host Disease~   "
27685|NCT02694757|"~     The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing~     readmission rates of subjects with new ileostomies in the first 30 days post-operatively.~   "
27686|NCT02694744|"~     The purpose of this study is to evaluate the efficacy and safety of patiromer (the~     investigational medication) administered once daily (QD) when given with food compared to~     without food for the treatment of hyperkalemia (high potassium in the blood).~   "
27687|NCT02694731|"~     Participants will complete a 5-week smartphone app-based intervention that teaches mindful~     eating skills. One goal is to determine to what extent participants will enjoy using the app~     and complete the intervention. The investigators predict that after completing the~     intervention, participants will report fewer episodes of eating in response to food~     cravings. The investigators will also measure several other biological and behavioral~     outcomes.~   "
27688|NCT02694718|"~     The purpose of this study is to determine the pathological complete tumor response rate.~   "
27689|NCT02694705|"~     Comparison of the preoxygenation efficacy of tidal volume breathing using three different~     preoxygenation techniques which are available to providers in the prehospital environment.~   "
27690|NCT02694692|"~     The primary aim for this study is to determine if maternal Kangaroo Care (KC) provided~     during painful procedures in early life will mitigate stress release and will improve~     neurobehavioural outcomes in infants, decrease subsequent pain response, and enhance~     maternal-child interaction beyond the period of hospitalization.~   "
27691|NCT02694679|"~     Social network targeting strategies can be used to improve the delivery and uptake of health~     interventions. We will enroll approximately 30,000 individuals into a randomized controlled~     trial of different targeting algorithms in order to explore how social network dynamics~     affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and~     infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras.~     Our goal is to develop methods by which global health practitioners can exploit face-to-face~     social network interactions in order to maximize uptake of neonatal and infant health~     interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2~     x 8 factorial design of different targeting algorithms.~   "
27692|NCT02694666|"~     This study is to investigate the effects of controlled whole-body vibration training on~     preventing falls among healthy population and people with multiple sclerosis.~   "
27693|NCT02694653|"~     To evaluate the use of maternal opiates for pain control post cesarean delivery in those~     patients that received intravenous acetaminophen 1000 mg in 150 mL of normal saline, infused~     30 minutes prior to incision compared to placebo. A comparison of post delivery length of~     stay in both study groups will be evaluated for cost effectiveness of the use of~     acetaminophen. a secondary purpose is to determine the levels of neonatal acetaminophen in~     cord blood at the time of delivery, since this has never been studied.~   "
27694|NCT02694640|"~     Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained~     American Cancer Society volunteers to provide exercise counseling to breast cancer survivors~     and the survivors increased their exercise in the short-term. This RCT examines the effects~     of three maintenance conditions on survivors' exercise participation at longer follow-ups.~     The cost-effectiveness of the three groups will be examined to guide implementation of this~     peer mentoring approach in community-based organizations.~   "
27695|NCT02694627|"~     This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group~     education intervention on men's attitudes towards, and participation in, sexual and~     reproductive health, maternal, newborn and child health, and equitable and non-violent~     relationships with their children and partners.~   "
27712|NCT02694406|"~     As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide~     number of immature microvessels. These vessels are characterized by a lack of coverage by~     pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth~     Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio~     pathogenic characteristics have been demonstrated to be in line with variations of MR~     perfusion parameters.~      Unlike many lesions that occur in other parts of the body, biopsy should not be performed in~     adnexal masses that demonstrate no evidence of peritoneal disease because it may cause~     spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have~     been a malignant tumor that was limited.~   "
27713|NCT02694393|"~     This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis~     and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce~     the burden of Pseudomonas.~   "
27696|NCT02694614|"~     The purpose of this study is to evaluate the effectiveness and feasibility of weight loss~     counselling via a smartphone-app for patients with overweight/obesity in a 1-year long pilot~     study.~      The study is organized in the following phases:~      Recruitment (-14 to -2). Participants will be informed about the study. Participants agreed~     to enter the study and signed an informed consent.~      Screening / Baseline measurement (week -2) Inclusion criteria will be checked.~     Anthropometric measurements: height, weight, waist circumference, body fat, blood pressure~     measurement, blood sampling for blood glucose; HbA1c, Insulin; Triglyceride, HDL-Cholesterol~     (assessment Part I). During the visit participants are requested to fill in a paper-pencil~     questionnaire: socioeconomic background (only at the beginning of the study), dietary and~     exercise habits, health-related quality of life, self-effectiveness (assessment part II).~     The participants are introduced to the smartphone assisted coaching.~      Introductory phase (2 weeks): Participants take pictures of their meals with the app, which~     they send to the dietitian. After the introductory phase, the patients and the dietitians~     discuss via app how the patients should change their habits and agree on goals to reduce~     their weight.~      Phase 1 (12 weeks): Intensive online counselling with the smartphone app, with the agreed~     upon goals in mind (5 days per week + one Skype call). Group counselling session with /~     without a dietitian are held if necessary. Furthermore, the dietitians make available~     information material for patient specific dietary topics online. Week 12: assessment I+II.~      Phase 2 (until week 25): The habits that further a weight reduction are being stabilised -~     the frequency of the online counselling is reduced (3 days per week), group counselling with~     / without a dietitian are held if necessary. Furthermore, the dietitians hand out~     information material for patient specific dietary topics.~      Phase 3 (week 26-52): This phase is relevant for maintaining the patient's wright. Online~     counselling happens once every 2 weeks. Group counselling with / without a dietitian are~     held if necessary. Furthermore, the dietitians hand out information material for patient~     specific dietary topics. At the end end, the dietitians will again collect data (assessment~     I+II). The online counselling process is evaluated with 3 group discussions.~      Follow-up (week 104)~   "
27697|NCT02694601|"~     The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation~     of lipolysis and the production of ketones in healthy adults (N=10). Two different doses of~     caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the participants have to~     follow three sequential visits of four hours each, which included a breakfast with one of~     the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline)~     and repeated blood sampling in order to evaluate ketone concentrations.~   "
27698|NCT02694588|"~     Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated~     barrier diseases with shared inflammatory pathways. Current therapeutic interventions with~     anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific~     pathways of inflammatory immunopathology. Individual responses to biological treatment can~     be thereby be exploited in a systems biology approach that employs a targeted mechanism of~     action (MOA) to decipher molecular signatures of therapeutic responses in the context of a~     distinct disease entity. Using a translational approach to investigate clinical and~     molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte~     trafficking, the investigators aim to trace common and unique signatures of drug- and~     therapy-specific responses.~      Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall~     by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy~     prior to and during specific therapies with biologicals. In parallel, mucosa samples will be~     obtained to define molecular phenotypes during the course of therapy.~   "
27699|NCT02694575|"~     This is a cross-sectional observational study aiming to examine and compare the impact of~     incretin based therapies i.e. dipeptidyl peptidase-4 (DPP4) inhibitors and glucagon-like~     peptide-1 (GLP-1) analogues, on endothelial progenitor cells (EPCs) and its mobilising~     factor, stromal derived factor-1 α (SDF-1 α), in patients with type 2 diabetes mellitus~     (T2DM) who are well established on those treatments. EPCs provide vascular protection by~     means of endothelial repair and neogenesis. This endothelial protective effect may~     potentially benefit patients affected by micro or macrovascular complications arising from~     vascular injury e.g. cardiovascular disease in T2DM. The study is of particular interest as~     a small study has shown an increase in level of circulating EPC in patients treated with~     DPP-4 inhibitors, thought to be mediated via the up regulation of its mobilising factor~     SDF-1 α.~   "
27700|NCT02694562|"~     The purpose of this study is to determine safety and local tumor control of Embozene TANDEM~     Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma~     (mCRC).~   "
27701|NCT02694549|"~     The purpose of this study is to assess the performance and safety of the CaveoVasc® System~     for femoral vascular access and for prevention of bleeding from the femoral artery puncture~     site.~   "
27702|NCT02694536|"~     This open-label, single-arm, multicenter trial is designed to evaluate the safety of~     erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants~     with locally advanced, unresectable, or metastatic pancreatic cancer.~   "
27703|NCT02694523|"~     This is a randomized double blind, double dummy, active comparator controlled, parallel~     design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066~     (risankizumab) compared to adalimumab to support registration for the treatment of moderate~     to severe chronic plaque psoriasis in adult patients.~   "
27704|NCT02694510|"~     Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be~     measured in preterm infants less than 32 weeks gestation before and 7 days after receiving~     either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN)~     solutions.~   "
27705|NCT02694497|"~     Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular~     treatment to understand the transmission of anorectal CT infections.~   "
27706|NCT02694484|"~     Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent~     Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of~     a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors~     are being clinical and laboratory screening to reduce the likelihood of pathogens~     transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations~     requested by the Agence national de sécurité du médicament et des produits de santé in the~     context of clinical research. A sero-matching between donor and recipient CMV is requested.~     This recommendation eliminates many potential donors to a recipient. To date, the frequency~     detection level of CMV in stool in healthy volunteers with documented positive CMV serology~     is not known. In addition, CMV transmission risk via the stool is not established. This~     study aims to determine the detection frequency of CMV in healthy volunteers stool samples~     selected as potential donors for a FMT and having a positive CMV serology documented~   "
27714|NCT02694380|"~     The goal of this study is to measure the effect of radiation therapy on the activity levels~     of patients. This will be achieved by tracking their activity levels during a treatment~     course of radiation therapy.~   "
40735|NCT02523807|"~     Patients with tremor may have varying degrees of tremor at different times. The amplitude~     and frequency of tremor may change. The investigators observational study is intended to~     document this tremor.~   "
27715|NCT02694367|"~     The present study is based on hypotheses that some as yet unknown genetic factors may result~     in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new~     information about the underlying genetic causes of RM in the Egyptian population and to~     investigate the expression of ERK and p-ERK protein in human placenta and their~     corresponding tissue, to assess the significance of MAPK signal pathway in progression of~     recurrent miscarriage and PI3K-Akt Pathway.~   "
27716|NCT02694354|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single~     rising oral doses of BI 685509~   "
27717|NCT02694341|"~     The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage,~     including haemorrhage associated with placenta previa by compressing the lower uterine~     segment.~   "
27718|NCT02694328|"~     This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects~     with schizophrenia.~   "
27719|NCT02694315|"~     Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical~     Assessment prior to induction of labor as regards induction success.~   "
27720|NCT02694302|"~     A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its~     efficacy, safety over conventional gait training.~   "
27721|NCT02694289|"~     Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are~     admitted for HF, leads to reduced insulin requirements, as measured in units of insulin,~     with no negative impact on patient safety.~      This is a single center, prospective trial. Subjects will be randomized to initiate~     metformin (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR~     be placed on insulin products for management of their type 2 diabetes mellitus.~   "
27722|NCT02694276|"~     The aim is to evaluate if internet- delivered CBT, based on behavioral activation and~     exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will~     include 30 patients with symptomatic AF despite optimal medical treatment in accordance with~     current guidelines.~   "
27723|NCT02694263|"~     This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to~     monotherapy of metformin is more effective at achieving the double composite endpoint of a~     reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will~     also include patients currently on dual therapy, specifically metformin plus a~     sulphonylurea, pioglitazone or repaglinide to determine whether switching to metformin plus~     Canagliflozin (Invokana™) is more effective at achieving the composite endpoint compared to~     those remaining on previous dual therapy. There are a number of secondary outcomes including~     weight loss, rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.~   "
27724|NCT02694250|"~     This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical~     outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of~     degenerative disc disease at one disc level with accompanying radicular symptoms in the~     cervical (neck) spine.~   "
27725|NCT02694237|"~     The aim of the study is determine which method of informed consent improves comprehension in~     college educated patients in a private practice setting.~   "
27726|NCT02694224|"~     To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in~     breast cancer patients based on the CTCAE v4 2010~        1. To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first~          biopsy as compared to the later one~        2. To detect predictive factors among patients who reached pathological complete response~          (pCR) as compared to those with no pCR~        3. To evaluate the role of the addition of vismodegib in the pCR rate~        4. To evaluate clinical responses by breast MRI and rates of breast conservative surgery~          after neoadjuvant chemotherapy~        5. To evaluate QOL with EORTC QLQ-C30 scale~   "
27727|NCT02694211|"~     The Stress prevention at work (SPA) project intends to evaluate the method named~     Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach~     among health care employees.~   "
27728|NCT02694198|"~     Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester abortion.~   "
27729|NCT02694185|"~     Ischemic heart disease (IHD) and its treatment carry profound public health and economic~     implications. Among Veterans, IHD represents one of the most common causes of death and~     disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far~     less common than IHD can affect multiple organ systems and requires therapies costing in~     excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease~     requires a number of medications to maintain or improve health. Not taking medications as~     prescribed, however, is common and increases the risk of subsequent adverse events (cardiac~     death and myocardial infarction [MI]).~      To improve medication adherence rates and the cardiac health of Veterans with IHD, the~     investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM~     (Secondary Event Prevention using Population Risk Management After PCI and for~     Anti-Rheumatic Medications), this intervention will consist of: proactive real-time~     adherence monitoring of patients and targeting of individuals if they have not refilled~     their medication a given number of days after it was due for refill. The intervention will~     employ a tailored, escalating-intensity approach which begins with some combination of~     personalized short messaging service (SMS) text messages and interactive voice response~     (IVR) telephone technology, depending on patient preference. Patients not completing SMS and~     then IVR by not refilling their medication (or declining SMS and not completing IVR)~     escalate to a trained research interventionalist. The interventionalist will contact the~     patient and address adherence barriers based on the dimensions outlined by the World Health~     Organization (WHO) that are specific to each patient. The investigators will test the~     intervention on IHD patients who have recently undergone PCI-a cardiac procedure commonly~     used among IHD patients to improve the heart's blood flow and in patients starting~     anti-rheumatic medication. The investigators will test the intervention at four VA Cardiac~     Catheterization Laboratories (CCLs) and have 12 sites serving as usual care controls.~   "
27730|NCT02694172|"~     The main objective of the clinical trial is to investigate whether overweight type 2~     diabetic patients have a different fecal microbiota profile compared with age, gender, BMI~     matched subjects and with lean healthy subjects before and after the consumption of fiber~     rich cereal bars.~   "
27731|NCT02694159|"~     The study goal is to improve the value of care and reduce health disparities by developing a~     targeted set of sophisticated and powerful algorithms to improve upon human clinical~     judgments. The plan is to use the test case of detecting sepsis in patients in the emergency~     department (ED) as the first step in improving the value of care and reducing health~     disparities by developing a targeted set of sophisticated and powerful algorithms to improve~     upon human clinical judgments. This work will be performed using data from the University of~     Pennsylvania Health System where a preliminary Early Warning and Response System for Sepsis~     monitors clinical parameters. The premise underlying all this work is that by improving~     decision-making, it will both reduce low-value care and health disparities.~   "
27733|NCT02694133|"~     The study will invite 30 patients to join, and they will be arranged in the face to face~     group and telerehabilitation group randomly.~      In the telerehabilitation group, the investigators use the mobile device, which with the~     camera and speaker, for patients to practice the naming training at home, and assess the~     speech ability every 2-4weeks by speech therapist via telerehabilitation platform.~      Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as~     the assessment tool for evaluation speech ability and functional ability.~      The investigators expect that patients can improve their speech ability, functional ability,~     and quality of life via telerehabilitation speech therapy.~      And the investigators can establish the standard telerehabilitation speech therapy protocol~     for aphasia therapy.~   "
27734|NCT02694120|"~     Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer,~     through the recognition and removal of pre-cancerous lesions, which in most cases evolve~     with a sequence that goes through formation of high-grade dysplasia (HGD).~      The probability of HGD increases with the increase of the lesion of the polyp itself.~     Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions~     presents a greater technical difficulty and consequently a decrease in the efficiency. The~     rate of incomplete resection reported in the literature reaches 10% while that of recurrence~     / residual adenoma 16.4 / 31.7%.~      The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost~     of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an~     unselected population~   "
27735|NCT02694107|"~     The purpose of the present study was to measure the effect of proprioceptive training,~     short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.~      Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which~     would perform proprioceptive exercise, or the control group(n=19, no intervention) .~   "
27736|NCT02694094|"~     This research is being done to evaluate the short term and long term effects of ketogenic~     diets on measures of cardiovascular health. Such measures include cholesterol levels, blood~     pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older~     who are already on a ketogenic diet for at least 12 months or who are interested in~     beginning on the modified Atkins diet may join.~   "
27737|NCT02694081|"~     The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II~     Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.~   "
27738|NCT02694068|"~     Peritoneal Dialysis (PD) is a technique for treating kidney failure where fluid is instilled~     into the body's peritoneal cavity. Fluid and solutes travel across the peritoneal membrane,~     and the function of this membrane is critical to successful PD. Studies have shown that~     certain demographic and clinical variables explain a very small part of the variability in~     baseline function. This study will further explore the common genetic variants that~     determine the baseline peritoneal membrane function in patients starting treatment with PD~     and change in function upon treatment .~      This study will incorporate data from subjects' first ever peritoneal equilibrium test~     (PET), changes in the transfer of water across the peritoneal membrane over time,~     demographic information, and results from laboratory analysis of DNA, blood, and dialysate.~     The investigators hope that this study will provide information on the biological pathways~     that account for variability in the peritoneal membrane. This could ultimately lead to the~     development of biomarkers to identifying individuals at risk for decline in peritoneal~     membrane function over time and/or be used to identify novel therapeutic targets to preserve~     or enhance membrane function. Identifying the biological pathways will also increase the~     understanding of vascular biology, angiogenesis, and fibrosis that could be applied to other~     tissues and other diseases.~   "
27739|NCT02694055|"~     The purpose of this study is to evaluate whether the addition of Proactive Case Detection to~     Community Case Management will provide an increase in early access to health care and a~     reduction in deaths among children aged 0-59 months. Integrated Community Case Management is~     the package of community-based services for children delivered by Community Health Workers~     (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and~     malnutrition. In many i-CCM interventions, CHWs are stationed in their villages and~     available in a passive, reactive manner to provide care to patients who seek them out. This~     study seeks to determine whether the addition of proactive case detection by CHWs, in which~     the conduct daily door-to-door home visits to find and care for patients, improve early~     access to care and reduce child mortality.~      Villages will be randomised to receive Integrated Community Case Management (i-CCM) from a~     passive CHW or Proactive Community Case Management (Pro-CCM) from a CHW that conducts daily~     active case finding home visits. All villages in both study arms will receive additional~     interventions that could significantly reduce under-five mortality, including removal of~     point-of-care fees, clinical staff training at primary health centres, and improvement in~     health centre infrastructure.~      All women of reproductive age eligible for inclusion in the study will be surveyed at~     baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction~     in child mortality in both study arms, with a significantly larger reduction where there is~     proactive case detection, or Pro-CCM, by CHWs. An exhaustive survey of 22 847 women of~     reproductive age followed for three years will give a study which has 90% power to detect an~     absolute difference of 0.75% (and a relative difference of 25%) in under-five child~     mortality reduction between the two study arms.~   "
27740|NCT02694042|"~     Crohn's disease and ulcerative colitis, known together as inflammatory bowel disease (IBD),~     are chronic inflammatory conditions of the gastrointestinal tract. Impacts of IBD such as~     frequent hospital visits, need for surgery and poor growth, can significantly impact a~     child's social and academic life. Dealing with a chronic disease forces children to rely~     more heavily on family members for coping strategies to deal with stress. However, a lot of~     families do not have the resources (emotional or financial) to provide the level of support~     needed. A self management site called Mission is Remission® has been created to help~     adolescents and their families deal with the stressors associated with their disease. The~     site provides a supportive social network that is centred around learning sessions and~     active forums discussing topics related to disease self-management and coping. This site~     actively brings together members of the healthcare team and provides support to families who~     might not be able to travel for additional appointments outside of routine care. The goal of~     our research is to understand whether the changes this social support will increase~     disease-specific knowledge, medication adherence, and health-related quality of life. We~     will also examine whether these changes may reduce some of the demands placed on the Health~     Care system (e.g., reduced number of calls and visits to gastroenterology (GI) doctors, or~     time lost from school/work). In addition, this website has been designed to be adapted in~     the future to other chronic diseases and will help bring healthcare into the digital age.~   "
27741|NCT02694029|"~     Female patients treated with radiation for left-sided breast malignancy will undergo~     alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted~     Deep Inspiration Breath-Hold (DIBH).~   "
27742|NCT02694016|"~     The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective~     effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing~     isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological~     evaluation preoperatively and at 30d after surgery will establish if there are any~     differences in neuropsychological performance between groups. A large array of biochemical~     markers will be analyzed from plasma samples taken at different time points. Additionally~     skin biopsies from the lower limb will be taken before and after performing RIPC on said~     limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical~     markers from plasma and tissue samples will be used to asses brain tissue damage,~     inflammation and cardiac tissue damage between groups.~      This will be a single center prospective randomized study with two groups. A intervention~     group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per~     group.~   "
27743|NCT02694003|"~     More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems,~     whereas less than 25% of typically developing children experience sleep problems. Poor sleep~     can have significant consequences for children's physical and psychosocial health, as well~     their caregivers' well-being. The impact of sleep problems on daytime functioning is even~     greater in children with NDD. Although there are a range of factors that may disturb sleep~     in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia.~     There is some evidence that behavioural interventions can be effective in improving sleep in~     children with NDD. However, this has not been tested through well-designed, large-scale~     randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to~     access for insomnia treatment for children; most importantly, sleep interventions are often~     only provided by specialists, limiting access to treatment services. Instead, behavioural~     insomnia is often treated with advice about sleep hygiene and with the supplement melatonin,~     which is, at best, a short-term solution. The investigators, an interdisciplinary team of~     researchers, will develop and evaluate the effectiveness of an online sleep intervention~     that will be widely accessible and sustainable and will have the potential to dramatically~     improve the health of children with NDD and their families.~   "
27744|NCT02693990|"~     This research study is studying radiation therapy as a possible treatment for meningioma or~     tumor on the lining of the brain. The study drug or intervention involved in this research~     study is Intensity Modulated Proton Therapy (IMPT)~   "
27745|NCT02693977|"~     Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in~     breathing during sleep. It affects at least 1-3% of the general pediatric population with~     greater prevalence among certain high risk groups such as children with obesity, Down~     syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown~     that, even after having adenotonsillectomy (AT), approximately 30% of children continue to~     struggle with OSA. They further found that older children (age > 7 yrs), obesity, and high~     pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these~     known risk factors, the ability to predict each individual patient's risk of residual OSA~     after tonsil surgery is difficult. Determining what tool will best predict residual OSA is~     an important step towards more effective post-surgery OSA management.~      The purpose of this study is to determine whether sleep endoscopy can predict whether their~     AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple~     areas of obstruction in addition to large tonsils will be more likely to have residual OSA~     after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves~     passing a flexible endoscope through the subject's nose into the back of the throat to look~     for sources of obstruction while breathing spontaneously.~      This will be a prospective cohort study examining subjects between the ages of 2 and 18 who~     are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk~     for residual OSA after surgery. High risk will be defined based on the following criteria:~     obesity, Down syndrome, African American race, severe baseline OSA, and age > 7 yrs.~     Eligible subjects will be recruited from the pediatric otolaryngology clinic at the time of~     initial evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation~     at the time of AT. All patients will be asked to complete a preoperative sleep study to~     confirm the diagnosis of OSA and a postoperative sleep study to determine the impact of AT~     and the presence of residual OSA. Secondary outcome measures will include several~     questionnaires assessing generic and OSA-specific quality of life as well as subjective~     measures of cognitive/executive functioning and daytime sleepiness.~   "
27746|NCT02693964|"~     The study is aimed to evaluate the differences in bone mineral density (BMD) and Carotid~     Intima Media Thickness (CIMT) between postmenopausal women with type 1 diabetes (T1D)~     compared to postmenopausal women without diabetes.~   "
27747|NCT02693951|"~     The purpose of the study is to assess the efficiency and safety of prophylactic use of~     antibiotics in endoscopic injection of tissue adhesive in gastric varices.~   "
27748|NCT02693938|"~     This research study is designed to look at differences in responsiveness to the subcutaneous~     injection of a standardized dose of rapid-acting insulin analog and blood glucose~     variability during different phases of the menstrual cycle in females with type 1 diabetes~     (T1D).~   "
27749|NCT02693925|"~     The purpose of this study is to determine the prevalence of sleep-related breathing~     disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic~     by means of polygraphy.~      Furthermore, the practicability of the underlying diagnostic process in clinical application~     is assessed as well as the sensitivity and specificity of polygraphy as compared to the~     reference standard of polysomnography. Another aim is to determine the individual~     cardiovascular risk profile by pulse wave analysis and risk classification according to~     European Society of Hypertension (ESH) and European Society of Cardiology (ESC), ESH/ESC~     risk.~   "
27750|NCT02693912|"~     In this study, the investigators aim to observe the change in alveolar macrophage function~     during acute lung injury.~   "
27751|NCT02693899|"~     Despite advances in their classification and treatment, acute leukemia remain incurable~     disease for the majority of patients. It is necessary to identify new prognostic markers of~     survival and new therapeutic targets to improve prognosis. Some studies have shown that~     Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent~     study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an~     increase of this marker in the blood of patients responding to treatment. The aim of our~     prospective, non-interventional study is to measure the plasma levels of FLT3-L at different~     times of the management of patients with acute lymphoblastic leukemia but also myeloid. For~     this, analyzes of the samples collected in the usual care will be conducted to study the~     relationship between the plasma concentration of FLT3-L and outcomes. If there is any link,~     the FLT3-L could serve as a predictor of treatment response.~   "
27752|NCT02693886|"~     Individualized colonoscopy withdrawal time is determined based on the different grade of~     physician experience and quality of bowel preparation.~   "
27753|NCT02693873|"~     Osteoarthritis (OA) most often affects the hip and knee joints. The first signs and symptoms~     of pain, stiffness or swelling are not uncommon in those in their thirties and forties and~     10 per cent report symptomatic knee OA by age 60 years. Education and exercise are essential~     for people with OA to help them manage their condition better. Exercise can reduce pain,~     improve mobility and enhance quality of life. However, doing the right exercises in the~     right way is important so that joints are not overly stressed.~      The purpose of this study is to evaluate an existing evidence-based program called, Good~     Life with osteoArthritis in Denmark (GLA:D). The program has been translated and adapted to~     the Canadian context and will now be implemented in a Canadian therapy setting to start to~     understand if it is effective. This is the first time this program is being tested in~     Canada.~      While some people have access to self-management programs for OA, these programs often~     provide only general exercise guidance and education. GLA:D integrates patient education and~     targeted, personalized exercise for people with hip and/or knee OA. Importantly, the~     exercises are taught so that individuals learn to incorporate them in their everyday~     activities. This research is the first step to understanding if people participating in this~     program have pain relief and improved function and if they are better able to manage their~     hip or knee OA symptoms. Additionally, this initial evaluation of the program will help~     create a better understanding of the challenges in delivering the program. This will be~     valuable information for offering future programs assuming success of this pilot study.~      It is anticipated that about 60 people (30 hip OA and 30 knee OA) will participate in this~     study. These people will be recruited from the Sunnybrook Holland Orthopaedic and Arthritic~     Centre in Toronto, Ontario, Canada. All consenting participants will receive the GLA:D~     Canada program delivered by Sunnybrook's therapists.~   "
27754|NCT02693860|"~     10 patients will be enrolled in the initial cohort and will receive two infusions of~     unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a~     positron emission tomography-computed tomography (PET/CT) will be performed week later on~     day 28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient~     will undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days).~     The final visit for the study will include a postoperative visit two weeks following~     surgery.~   "
27755|NCT02693847|"~     Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in~     Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic~     active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the~     basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant~     decompensation of liver disease. Patients are prospectively followed-up according to a~     uniform protocol of care. Epidemiological, clinical and laboratory variables are~     periodically recorded. The primary outcomes are the emergence of a liver decompensation~     (including hepatocellular carcinoma), liver transplant or death. The predictors of these~     outcomes are analyzed.~   "
27756|NCT02693834|"~     PURPOSE: The purpose of this study will be to identify whether patients in the subacute~     stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a~     Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to~     determine whether one week of practice significantly changes gait outcomes with either of~     the AFO conditions.~      INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity,~     diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in~     hemiparesis with foot drop will be recruited for this study.~      EXCLUSION CRITERIA:~        1. Not able to receive a double adjustable AFO through their insurance~        2. Unable to follow two steps commands~        3. Unable to ambulate 20 feet with or without assistive device with a minimum level of~          assistance of contact guard assistance.~        4. Cerebellar Stroke~        5. Inability to ambulate prior to stroke~      OUTCOME MEASURES:~        1. Six Minute walk test~        2. Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and~          fast paced velocity walk.~      DATA COLLECTION:~      Data will be collected three times over two weeks period.~      First Visit:~      Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental~     State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order.~     Afterwards participant will be given one type of AFO (randomly selected) to practice walking~     for a week.~      Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing~     with. Then the other type of AFO will be given to practice walking for a week.~      Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were~     practicing with the week prior. Patient will be asked which type of AFO they prefer to use.~   "
27757|NCT02693821|"~     The study's objective will be to evaluate the gabapentine efficiency in orally and long term~     used after painfully surgeries.~   "
27758|NCT02693808|"~     The purpose of this study is to determine whether injection of autologous fat or~     hyaluronic-acid injections in temporal region are effective in the treatment of temporal~     hollowing after lateral wall decompression in patients with thyroid eye disease.~   "
27759|NCT02693795|"~     Left ventricular (LV) remodeling following myocardial infarction (MI) is an established~     prognostic factor for adverse cardiovascular events and the leading cause of heart failure.~     Empirical observations suggests that Baduanjin exercise, an important component of~     traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However,~     the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients~     recovering from recent MI has yet to be assessed. The aim of this trail is to evaluate~     whether Baduanjin exercise would prevent the maladaptive progression to adverse LV~     remodeling in patients following MI.~   "
27760|NCT02693782|"~     This is a placebo controlled, cross-over, randomized, double blinded study. The intervention~     food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in~     arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day).~     2. Placebo product maltodextrin:equal amounts of a digestible carbohydrate.~      Primary endpoints are faecal microbiota analysis and faecal metabolite analysis~     (particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose,~     HDL and bowel function, gastrointestinal tolerance, quality of life and food frequency (by~     the use of questionnaires).~   "
27761|NCT02693769|"~     The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated~     inhaler is effective and well tolerated in the treatment of subjects with fixed airflow~     obstruction and elevated eosinophils.~   "
27762|NCT02693756|"~     Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in~     patients with neurological diseases or in healthy elderly persons with exercises.~      There is evidence that mental practice, also called motor imagery, the imagination of~     performing a movement, can also improve an activity or balance. The effective performance~     and the imagination of a task activates some overlapping central areas and neural networks,~     which might explain the improvements after motor imagery.~      The investigators set out to test the feasibility of such a study using an open label~     randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is~     to evaluate whether the instructions are clear, the intervention and the study procedures~     are acceptable and to assess the proportion of participants withdraw from the study (drop~     outs). Secondary aims are the assessment of between group differences in the changes of the~     gait stability.~   "
28270|NCT02687113|"~     The purpose of this study is to determine whether fusion technique of pre-radiofrequency~     ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would~     improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography~     guidance alone.~   "
27763|NCT02693743|"~     Suicide was responsible for almost 40,000 deaths in 2011 in America. It is still singularly~     difficult to predict who is going to commit suicide and how to establish adequate~     interventions. Growing evidence supports the view that suicide is associated with poor~     decision making. Suicide is hypothesized to be triggered by stressful situations that create~     overwhelming psychological pain in an individual who chooses to terminate his/her own life,~     disregarding all future consequences. We have previously demonstrated rewarding impulsive~     choice common to both recent suicide attempters and suicidal depressed patients (1).~     Consistent with these findings, we hypothesize that high frequency repetitive transcranial~     magnetic stimulation (rTMS) of the left prefrontal cortex will improve impulsive response~     tendencies as measured by the delay discounting procedure, and this in turn will be~     associated with a faster resolution of suicidal ideation. To these effects we will be using~     a randomized control trial of rTMS in adult inpatients at the Psychiatric Research Institute~     (PRI) hospitalized for acute suicidality. At the conclusion of these studies, we will have~     tested the value of decision making in the development of suicide ideation and behavior, as~     well as piloted the use of rTMS in the treatment of these patients.~   "
27764|NCT02693730|"~     The purpose of this research study is to improve the understanding of irritable bowel~     syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance~     imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared~     to healthy controls and people with ulcerative colitis, a disease group that has already~     been characterized. By doing this correlative and comparative study, the investigators hope~     to gain knowledge on IBS in order to keep the field moving in the right direction and~     becoming one step closer to discovering effective treatments.~   "
27765|NCT02693717|"~     The goal of this clinical research study is to learn if Alimta (pemetrexed) can help to~     control urothelial cancer. The safety of this drug will also be studied. Researchers will~     also study how a gene called MTAP may affect the way the study drug works.~   "
27766|NCT02693704|"~     This study investigates the possible benefits of using binaural spatialization techniques in~     digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker~     localization tests and preference tests are performed. The results of a diotic (current~     rendering) and a binaural (suggested rendering) rendering are compared.~   "
27767|NCT02693691|"~     The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used~     in a real-world setting.~   "
27768|NCT02693678|"~     Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint~     . The study aim is to assess the effect of manual massage, diathermy and sham diathermy the~     proprioception of the knee joint in patients affected by DOMS.~   "
27769|NCT02693665|"~     To test the efficacy of FACE-TC on key outcomes, the investigators propose using an~     intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT)~     design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads;~     N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU)~     control. Participants will complete standardized questionnaires at baseline and 3, 6, 12,~     and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps~     adolescents and young adults with cancer and their families: (1) reach and maintain better~     congruence in treatment preferences over time; (2) improve their quality of life; and (3)~     document goals of care and advance directives earlier in the course of their potentially~     life limiting illness.~   "
27770|NCT02693652|"~     A single center, open labeled phase I/IIa study to evaluate safety, tolerability and~     efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic~     hepatitis B virus carriers~   "
27771|NCT02693639|"~     The purpose of this study is to determine prediction value of PANX1 expression in infection~     post liver transplantation.~   "
27772|NCT02693626|"~     The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018)~     project is to assess whether a program of widely accessed mobile phone-based text message~     interventions ('Happy Quit') will be effective at helping people in China who smoke, to~     quit. Based on the efficacy of previous studies in smoking cessation, it is hypothesized~     that 'Happy Quit' will be an effective, feasible and affordable smoking cessation program in~     China.~   "
27773|NCT02693613|"~     The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics~     of single dose of ASP1517 in healthy non-elderly adult male subjects when administered~     concomitantly or in a time separated manner.~   "
27774|NCT02693600|"~     1. Introduction:~           Investigators think that surgery with preservation of healthy joints~          (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting~          sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its~          collapse and thus preserving the stability of the carpus.~        2. Objectives and Hypothesis:~           Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better~          results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with~          total trapeziectomy.~           Main Objective:~           To demonstrate using the dynamometer that the postoperative key pinch strength higher~          using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.~           Secondary objectives:~           To measure the collapse of the first column of thumb using calibrated radiographic~          analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of~          life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire).~        3. Methodology:~      It is a single-center randomized trial, parallel-group, in which two types of surgical~     techniques (TT - TP) will be compared. Patients will be randomized in this two techniques~     will be followed for one year, in routine clinical practice.~   "
27804|NCT02693210|"~     WA16291 is a Phase IIa proof-of-concept study. The primary objective of this study is to~     determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal~     antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide~     in participants with rheumatoid arthritis who have failed prior Disease Modifying~     Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to~     methotrexate.~   "
28035|NCT02690168|"~     Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic~     patients, which causes them to have severely low blood sugar levels. This condition makes~     clinical management of blood sugar in diabetic patients very challenging. This research~     seeks to better understand how diabetic patients develop HAAF, and what can be done to~     prevent it.~   "
27775|NCT02693587|"~     In Denmark, every 4 birth induced, most often due to prolonged pregnancy, up til 10-12 days~     after term. A group (RADS) set up by the Danish Regions has recently recommended induction~     with prostaglandins in tablet form (Angusta®). The recommendation is based primarily on the~     results of a meta-analysis published by the Cochrane Library, where various prostaglandin~     medications were compared.~      Vaginal prostaglandin insert (Misodel®) have proved safe in American Studies and is~     registered in Denmark for use of induction. Misodel® was not included in RADS's evaluation,~     as there are only few studies on the effectiveness and side effects.~      In the current study, investigators want to compare two different regimes for the induction~     of primipara who use respectively Misodel® and Angusta® as the primary method. The study is~     based on prospective collection of data from three divisions in Region Zealand, where~     investigators primarily compare the efficacy and safety but also to evaluate women's~     experience, the cost of medicine and consumption of resources in the maternity wards.~   "
27776|NCT02693574|"~     Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the~     Eradication of Helicobacter Pylori in Syrian population~   "
27777|NCT02693561|"~     Smoking is an important public health issue. The self help books may have important~     motivational implications which associated with deep breath exercises could cease the habit.~     Goals: Verify the effectiveness of the deep breaths exercises from the self help books along~     with the two motivational interventions to quit smoking on the anxiety, depression and daily~     consumption levels. Method: The study will be both prospective and controlled. Individuals~     will be distributed randomly in 4 different groups: The first group will be doing the deep~     breath exercises, the second group will read a self help book, the third group will do both~     reading and exercises and the fourth group will be the control. Anxiety, depression,~     motivational level and the cigarettes daily consumption will be evaluated previously and~     after the 15 days intervention. Expected results: Decreasing in anxiety, depression and~     cigarette consumption plus an increase in the motivation to quit smoking.~   "
27778|NCT02693548|"~     SAFEHEART is a large, on-going registry study in molecularly defined patients with~     heterozygous FH treated in Spain.~   "
27779|NCT02693535|"~     The purpose of the study is to learn from the real world practice of prescribing targeted~     therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be~     a drug target or to predict sensitivity to a drug.~   "
27780|NCT02693522|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human growth~     hormone on adult growth hormone deficiency~   "
27781|NCT02693509|"~     Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients~     hospitalized with heart failure. The program aims to help ensure that eligible patients are~     initiated on guideline recommended therapies and receive appropriate counseling prior to~     hospital discharge.~   "
27782|NCT02693496|"~     Patients with lung nodules may develop a variety of potentially severe symptoms. These~     symptoms may impact a patient's quality of life and lead to difficult treatment. Through~     this research program, the investigators want to understand the pathogenesis of the changes~     of these symptoms.~   "
27783|NCT02693483|"~     Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean~     endometritis.~   "
27784|NCT02693470|"~     Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic~     vascular diseases, including stroke, myocardial infarction, and impaired microcirculations,~     among which circulating microparticles play an important role. In severe psoriasis, there~     are increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers~     in parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would~     decrease the level of microparticles remains unknown.~      Objective: The investigators will evaluate the level of microparticles among normal control,~     severe psoriasis before and 4 months after ustekinumab treatment.~   "
27785|NCT02693457|"~     This randomized controlled trial is designed to determine the effect of suction drain usage~     on the reduction of postoperative swelling following total knee replacement. Furthermore,~     this study will determine the relationship between postoperative swelling and quadriceps~     muscle function. This study will be performed in a cohort of patients undergoing bilateral~     total knee replacement and the suction intra-articular drain will be randomized to one of~     the two operative knees prior to surgery.~   "
27786|NCT02693444|"~     Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness.~     The level of pain is often a limiting factor when assessing shoulder range of motion and~     strength pre-operatively. Pain itself has even been a cause of weakness due to muscle~     atrophy.~      The purpose of this study is to further understand the effect pain has by measuring constant~     shoulder scores in patients before and after ultrasound guided subacromial (the outer end of~     the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to~     saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The~     saline and lidocaine has been approved for use by the U.S. Food and Drug Administration~     (FDA). The constant shoulder score includes your level of pain, activity level, range of~     motion and strength measures.~   "
27787|NCT02693431|"~     Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic~     treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of~     them and those around them, stressful, rarely expressed, but noticeable by the care team. In~     line with the recommendations of the High Authority of Health, the multidisciplinary team of~     Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University~     Hospital offers a therapeutic education program tailored to the needs of children with~     cystic fibrosis and their families . The aim is to support children and parents in the~     acquisition of self-care skills (knowledge and skills) and coping skills, such as managing~     stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills~     of the child, facilitates its expressive capabilities and reduces anxiety.~   "
27788|NCT02693418|"~     The objective of this study is to determine the magnitude and duration of the reduction in~     pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g~     compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH will be~     measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants~     will be assessed for an exploratory endpoint to the determine effect of one dose of Acidform~     gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis~     (BV).~   "
27789|NCT02693405|"~     Significant advances in primary malignant brain tumors (PBT) treatment have led to~     dramatically improved survival, both in children and adults. However, survival has not come~     without a cost and aggressive treatment methods associated with significant long-term~     adverse effects, often referred to as late effects (Panigrahy & Blüml, 2009). These~     effects are the medical, physical, cognitive and psychosocial sequelae associated with~     cancer and its treatments that generally emerge two to five years after treatment ends~     (e.g., Landier & Bhatia, 2008).~      The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One~     especially important cognitive domain is executive functioning, which refers to essential~     factors such as problem-solving, goal-directed behavior and the ability to maintain stable~     interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive~     impairments on behavioral regulation and quality of life, few studies were conducted with~     survivors of PBT specifically for the assessment of executive functioning. Another~     fundamental neuro-cognitive domain is social cognition, which refers to the ability to~     understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive~     deficits are expected to impair autonomy and relationships, but scarce attention has been~     devoted to the study of social cognition in survivors of PBT and no study has attempted to~     compare socio-cognitive data and measures of health-related quality of life. It is~     noteworthy that executive function and socio-cognitive skills improve throughout childhood~     and adolescence, and improvements in these skills have frequently been attributed to~     maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This~     suggests a greater impact of the disease and its treatment on these functions in~     children/adolescents.~   "
27790|NCT02693392|"~     In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the~     existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract~     will be evaluated using standard methodology.~   "
27791|NCT02693379|"~     The purpose of this study is to determine whether smartphone photos may assist health-care~     worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical~     examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with~     conventional VIA, for human papillomavirus (HPV) positive women.~   "
27792|NCT02693366|"~     The purpose of this study is to analyze the safety, renal function, metabolic disorders and~     quality of life data in patients with focal segmental glomerulosclerosis treated with~     endovascular infusion of bone marrow derived mononuclear cells.~   "
27793|NCT02693353|"~     Prospective, observational cohort study evaluating the association between pre-surgical~     existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid~     macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.~   "
27794|NCT02693340|"~     This is a monocentric prospective study for the collection of biological samples (blood and~     biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive~     markers of response to biological treatments in inflammatory bowel disease (IBD).~   "
27795|NCT02693327|"~     This research study will examine the relationship interconnecting medical body health,~     mental health, and microbes of the digestive tract in persons living with serious mental~     illnesses,as compared to persons without such disorders. Existing research suggests that~     interactions between digestive tract microbes and the body may influence brain function~     circuits, mood, anxiety state, cognition, behavior, and medical physiology.~   "
27796|NCT02693314|"~     The purpose of this study is to determine the effects of the two doses of Jarro-Dophilus~     EPS® probiotic supplements on fecal lactobacillus and bifidobacteria numbers, transit~     survival of administered probiotic strains, fecal microbiota, gastrointestinal function and~     general wellbeing in healthy human adults.~   "
27797|NCT02693301|"~     This study aims to analyze the effects of an exercise program in the pulmonary function,~     cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle~     function, agility, and psychological health in a group of children with asthma and~     respiratory symptoms.~   "
27798|NCT02693288|"~     Distal radial fracture reparations by volar plating are often managed under regional~     anaesthesia, but are associated with severe pain when the block ends. Acute post-operative~     pain may delay rehabilitation, and even be a risk factor for the development of chronic~     pain. The use of opioids and the inevitable opioid-related side effects further decrease~     patient satisfaction. A multimodal approach to pain management should include local or~     regional analgesia technique when possible. In the case of wrist fractures, two methods are~     available: peripheral nerve block by the anaesthesiologist or surgical site local~     infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly~     used for the management of postoperative pain after diverse orthopaedic surgeries.~      The purpose of this study was to determine the equivalence between ultrasound-guided~     peripheral nerve block and local infiltration by the surgeon for short-term postoperative~     analgesia after surgical reparation of isolated closed wrist fractures by volar plating~     under regional anaesthesia. The quality of postoperative pain, patient satisfaction and~     adverse events were recorded for the first 48 hours following surgery.~   "
27799|NCT02693275|"~     This study is being conducted to create a database for the Quotient® System iPad Test. Using~     community sampling, NCS Pearson will compile the results of this study to create a database~     against which the results of clinical Quotient tests may be compared to determine patient~     performance relative to the expected results for developmental age and gender.~   "
27800|NCT02693262|"~     Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about~     how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient~     cardiovascular health and quality of life. Patients are being asked to participate in this~     study if they have a history of heart failure and have or are scheduled to be implanted with~     a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting~     that works with the cardiovascular system to optimize their heart rate during physical~     activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer~     setting, which also is able to adjust the heart rate by movement sensors, when necessary.~     This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by~     BIOTRONIK, Inc. There will be approximately 15 participants in this trial.~   "
27801|NCT02693249|"~     The purpose of this study is to investigate the psychological consequences of motor vehicle~     accidents and burn accidents in 7-18 years old children and adolescents. The impact of~     posttraumatic cognitions on developing psychological symptoms are of particular interest.~   "
27802|NCT02693236|"~     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic~     cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced~     esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin~     that transfected DC, which are used for DC-based immunotherapy. Based on the results of our~     previously performed preclinical study with DC vaccine combined with CIK cells, the~     researcher plan to perform the clinical trial.~   "
27805|NCT02693197|"~     The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and~     T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment~     compared to matched healthy control subjects.~      The secondary objective is to determine the safety and tolerability of single-dose T -817MA~     (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.~   "
27806|NCT02693184|"~     The purpose of this study is to validate a revised food frequency questionnaire that is~     designed to capture vitamin D, calcium and protein intake in a population of elderly men and~     women with fragility fractures. Protein, calcium and protein intake will be correlated with~     biochemical measures and bone mineral density measured by DXA.~   "
27807|NCT02693171|"~     The purpose of this study is to assess the incidence of human anti-chimeric antibody (HACA)~     in high-risk neuroblastoma patients treated with Unituxin combination therapy.~   "
27808|NCT02693158|"~     The primary objective of this multicenter, single-arm, observational study is to evaluate~     the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS~     Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an~     all-comers, real-world population.~   "
27809|NCT02693145|"~     CoRECT will help identify the important components of a data-sharing partnership between~     health departments and HIV care providers, and determine the extent to which a health~     department intervention can increase the number of HIV-infected persons out-of-care who: (a)~     link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load~     suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18~     months. We will also measure the cost-effectiveness of this intervention in regards to~     improved health in the individuals (re)-engaged in HIV care and reductions in further HIV~     transmission in the community.~   "
27810|NCT02693132|"~     Adults who are overweight or obese are typically prescribed a calorie-restricted diet and~     physical activity to promote weight loss and improve health. The manner in which physical~     activity is prescribed and monitored may influence physical activity engagement. Within the~     context of clinical research, physical activity has been prescribed in either a supervised~     or unsupervised manner. Supervised physical activity is typically done in a health-fitness~     facility under the direct supervision of trained staff. The alternative, unsupervised~     physical activity, promotes physical activity participation in a setting that is convenient~     to the individual. Unsupervised activity can be done in any environment or at any time that~     best suits the individual. Knowing the effects of unsupervised physical activity is~     important because of the translation of this type of physical activity to non-research~     settings. Therefore, knowing the magnitude of the physiological effects of unsupervised~     physical activity compared to supervised physical activity at the same prescribed intensity~     and dose is of clinical and public health importance. This study is designed to provide~     insight on these important research questions that can inform future research and the~     application to clinical, public health, and health-fitness settings.~   "
27811|NCT02693119|"~     This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center~     study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy~     of elamipretide (MTP-131) topical ophthalmic solution in this patient population.~   "
27812|NCT02693106|"~     The aim of this study is to evaluate the capacity of different dietary supplements to~     increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate,~     carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which~     multiple blood samples are taken in order to measure ketone production.~   "
27813|NCT02693093|"~     The purpose of this study is to determine the safety and efficacy of NI-03.~   "
27814|NCT02693080|"~     This pilot clinical trial studies computed tomography (CT) perfusion imaging in predicting~     treatment response in patients with non-small cell lung cancer or tumors that have spread~     from the primary site (place where it started) to the lungs (metastases) treated with~     stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that~     uses an injected dye in order to see how blood flow through tissues, including lung tissue.~     CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics~     of lung tumors may be predictive of response to treatment and whether lung perfusion~     characteristics can be used to follow response to treatment.~   "
27815|NCT02693067|"~     This study is intended to determine the safety, tolerability and reduction of biochemical~     markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and~     troublesome symptoms (particularly diarrhea and flushing) of intralesional injection of~     PV-10 in subjects with NET metastatic to the liver that are not amenable to resection or~     other potentially curative therapy.~   "
27816|NCT02693054|"~     Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.~   "
27817|NCT02693041|"~     Investigators hypothesize that~        1. intake of milk products containing probiotics are associated with a reduced risk of~          spontaneous preterm delivery.~        2. intake of milk products containing probiotics are associated with a reduced risk of~          preeclampsia.~        3. probiotics decrease the overall inflammatory state in the pregnant woman.~   "
27818|NCT02693028|"~     Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to~     pregnant women can be found in different maternal compartments and in the first stool and~     oral swab collected immediately after birth of a newborn delivered by cesarean delivery.~     Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the~     level of inflammation in different compartments of the mother and the infant.~   "
27819|NCT02693015|"~     This study aims to investigate the extent to which the time to angiography impacts on~     survival in patients hospitalised with NSTEMI.~   "
27820|NCT02693002|"~     Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12~     weeks to determine if markers of systolic and diastolic function change by echocardiography~     as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).~   "
27821|NCT02692989|"~     Trauma for hip joint is common in old people. Anesthesia in these types of old patients~     carries more risk than the adult population.~      In this study the investigators will review patient's records that underwent surgery for hip~     trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the~     rate of postoperative complications.~   "
27822|NCT02692976|"~     Prostate cancer is the only type of cancer in which conventional dendritic cells (DC)~     treatment has a beneficial effect on the overall survival. In this study investigators aim~     to show immunologic efficacy of tumor-peptide loaded natural DC in metastatic~     castration-resistant prostate cancer patients (mCRPC).~      The immunomonitoring will include:~        1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating~          lymphocytes against tumor peptides and~        2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and~        3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a~          immunogenic protein providing T cell help.~      The secondary objectives are the safety and feasibility of natural DC vaccinations, the~     influence on the quality of life during treatment with natural DC, and the clinical efficacy~     of treatment.~   "
27823|NCT02692963|"~     The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine,~     has been used to prevent tuberculosis for almost a century, and it is still the most used~     vaccine in the world. There is also circumstantial and indirect evidence that BCG~     vaccination can protect against malaria. Investigators hypothesize that BCG vaccination can~     offer protection against malaria in the Controlled Human Malaria Infection (CHMI) model.~      A total of 20 healthy male and female volunteers will participate in this randomized,~     single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination~     (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after~     vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the~     bites of five P. falciparum infected Anopheles mosquitoes.~   "
27824|NCT02692950|"~     Rates of advance directive completion among Americans, even those suffering from serious~     chronic illness, are notoriously poor. Moreover, the contents of completed advance~     directives are often difficult to interpret in the face of a medical crisis. The study aims~     to examine patient perceptions of electronic, interactive versions of advance care planning~     documentation.~   "
27825|NCT02692937|"~     The purpose of this study is to compare the effects of neurolysis with the effects of a~     exercise program on pain and other symptoms in individuals with chronic whiplash (WAD~     II-III).~   "
27826|NCT02692924|"~     Background:~      Gravid diseases are complications in pregnancy. They include gestational diabetes and~     preeclampsia. These can cause problems with how a fetus grows. Being pregnant with twins can~     make complications more likely. Research suggests that changes in fetal soft tissue may be~     the earliest signs of growth problems. These tissue changes are in lean mass, fat mass, and~     organ size. 3D images might detect these changes earlier than 2D images. This could help~     manage gravid diseases. The NICHD Fetal Growth Studies - Singletons measured fetal growth~     for four racial groups, Caucasian, African American, Asian, and Hispanic. Fetuses of obese~     women and women with twins were also measured. 2D and 3D images were taken at various stages~     of pregnancy. Measurements were taken after birth. Researchers want to expand this study by~     measuring organ volumes and body composition by racial group and in twins.~      Objectives:~      To set standards for body composition and organ volumes by race. To understand the~     relationship between gravid diseases and changes in fetal body composition and organ volume~     over the course of pregnancy. To find out whether these are different for twins than for~     single pregnancies.~      Eligibility:~      Women who participated in the NICHD Fetal Growth Studies - Singletons and Twins.~      Design:~      The data will come from the NICHD Fetal Growth Studies - Singletons and Twins.~      Researchers will review scans taken in the previous study. They will take measurements from~     the scans.~   "
27827|NCT02692911|"~     Background:~      The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of~     cancer death among women in Chile. Chile also has among the highest rates of gallbladder~     cancer and death in the world. Researchers in a high-risk region of Chile want to find out~     more about this type of cancer. They especially want to know how inflammation affects the~     way it develops.~      Objective:~      To better understand the causes of gallbladder diseases and factors that may be associated~     with them.~      Eligibility:~      Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health~     system.~      Other people over age 21 with gallbladder disease.~      Healthy adults over age 21.~      Design:~      Participants may be screened with an ultrasound. They may be asked questions about their~     health.~      Participants will have an ultrasound of the abdomen. This can be done at the study clinic or~     in the hospital or at home. The ultrasound uses sound waves to take pictures of the~     gallbladder.~      Participants will have a physical exam.~      Participants will have their mouths looked at for tooth loss, dentures, and gum redness.~      Participants will give a blood sample or saliva sample.~      Participants will be asked for access to their medical history. They may be asked to allow~     researchers to keep any samples taken during gallbladder surgery.~      Participants will answer questions about their medical history. This will include illnesses,~     surgeries, medicine use, and family history. It will also include diet and lifestyle habits,~     such as places where they have lived and worked.~      Some participants will have 3 follow-up visits over 6 years.~   "
27828|NCT02692898|"~     Background:~      The number of people who get tumors of the brain or central nervous system (CNS) is lower~     than other cancers. But these tumors cause a higher rate of serious effects and even death.~     Researchers want to test existing samples of tissue from these tumors to learn more about~     them. This may lead to better treatment.~      Objective:~      To study stored samples of CNS tumors to learn more about the tumors and explore new ways to~     diagnose them.~      Eligibility:~      The study will use tissue samples already collected at NIH from people with brain or CNS~     tumors.~      Design:~      The participants will have given their consent in a previous study.~      Researchers will review the tissue samples and any data collected about them.~      Researchers will do lab tests and scans on the samples.~      All data will be kept secure.~   "
27846|NCT02692664|"~     In this study, patients will be observed who receive an E-liac Stent Graft for treatment of~     isolated iliac aneurysms or an E-liac Stent Graft in combination with an E-tegra Stent Graft~     for treatment of aorto-iliac aneurysms.~      Objectives of this post-market registry are:~      Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm~     with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and~     feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or~     bilateral aorto-iliac or iliac aneurysm.~   "
27829|NCT02692885|"~     Background:~      The body uses energy from calories for basic functions like breathing and digesting food.~     Over time, when a person eats more calories than they burn, they may become overweight or~     obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue~     to learn more about metabolism. That is how the body uses food and other nutrients for~     normal function and energy. This research may help to develop new treatments for obesity and~     related diseases.~      Objective:~      To learn more about the role of fat and muscle in metabolism, particularly how fat and~     muscle store and use energy.~      Eligibility:~      Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected~     by the surgeon.~      Design:~      Participants will be screened by their regular NIH doctor. Then researchers will contact~     them about this study.~      Participants will not have to make extra visits to NIH for this study.~      Researchers will collect samples during the participant s surgery. These will be fat tissue~     and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be~     discarded. Collecting the tissue will not add any time or any extra incisions than what is~     required for the surgery.~      After surgery, blood will be drawn. Some participants will have this done in the pre-op or~     post-op room. Others will have this done during their hospital stay.~   "
27830|NCT02692872|"~     Background:~      Alpha thalassemia is a blood disorder. It is caused by genetic deletions. Part of the DNA is~     missing from a group of genes called alpha globin. Alpha thalassemias are some of the most~     common genetic deletions. We are testing for alpha thalassemia trait. Alpha thalassemia~     trait is when someone has only two out of the normal four alpha globin genes. In some~     people, they lead to no symptoms. Others have changes that lead to disease, including mild~     anemia. Researchers want to learn more about alpha thalassemia and blood vessels. This may~     allow them to develop new treatments for blood diseases such as sickle cell disease.~      Objective:~      To better understand how alpha globin deletions in healthy people affect blood vessels.~      Eligibility:~      Healthy volunteers ages 18 40 who self-report African ancestry.~      Design:~      Participants will provide a one-time saliva sample. This can be by mail, in-person at a~     study event, or at NIH.~      Participants will get a small kit to collect their saliva sample. The kit has easy~     instructions. The sample does not need to be put in the refrigerator.~      Participants will spit a small amount of saliva (less than half a teaspoon) into a~     collection tube.~      Participants will close the funnel lid tightly, and then unscrew the funnel lid from the~     tube. They will then close the tube tightly with the small cap provided and shake the tube~     for 5 seconds.~      Participants will place the tube in the provided envelope and mail it to NIH. The specimen~     will be stored and processed in the lab.~      Participants may be invited to participate in more research studies, whether or not~     researchers find that they have alpha thalassemia trait.~   "
27831|NCT02692859|"~     Haemophilus influenza type b (Hib) remains a serious global health threat associated with~     high mortality and morbidity in young children. In China, The overall impact of Hib-related~     infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally,~     vaccination has been considered the most effective way to prevent infection against Hib.In~     order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib)~     conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical~     trial is planned to conduct in healthy infants and children in China.~   "
27832|NCT02692846|"~     Background:~      Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that~     allows parts of the body to stretch than other individuals. Researchers are interested in~     the stretchiness of the skin of people with WS and how it may relate to cardiovascular~     problems some people with WS develop. They are also interested in identifying exposures such~     as medications that may change the elasticity of the skin and vessels.~      Objective:~      To learn more about the skin and blood vessels in individuals with WS and how those tissues~     change over time.~      Eligibility:~      People ages 5 70 with WS.~      People ages 1 70 with a medical condition that affects connective tissue.~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have 1 visit. Participants with WS may do so at a Williams Syndrome~     Association family meeting or camp, or at NIH. Other participants will be seen at NIH.~      During the visit, participants will have height, weight, and blood pressure measured.~      Researchers will listen to the participant s chest and abdomen.~      Participants skin will be examined. It may be photographed.~      Participants will have photos of their eyes and face taken.~      Researchers will use a DermaLab Suction Cup Probe. A small suction cup will be placed on the~     arm with a sticker. It will pull lightly on the skin. This allows a computer to measure skin~     flexibility.~      Researchers will use a SphygmoCor. A probe that looks like a dull pencil will be placed on~     the wrist, neck, and groin area. A computer will measure how fast the pulse is moving and~     will estimate blood vessel flexibility.~      Participants may be invited to have these procedures repeated at a later date (2 years from~     now or more).~   "
27833|NCT02692833|"~     The purpose of this study is to investigate whether biomarkers of cell senescence and aging~     can predict the development of acute kidney injury following cardiac surgery.~   "
27834|NCT02692820|"~     Babies born preterm (before completing 37 weeks in the womb) are at increased risk of~     long-term disability and death. The investigators do not fully understand the cause(s) of~     preterm birth but it occurs more frequently when the normal, healthy bacteria (called~     Lactobacilli) in a woman's birth canal are replaced with unhealthy bacteria. Previous~     attempts to get rid of the unhealthy bacteria with antibiotics have not shown to affect the~     risk of preterm birth. The reason for this may be that what is required is the replacement~     of Lactobacilli in the birth canal. This can be done by asking women to take capsules~     containing lactobacilli once daily. To study whether oral Lactobacilli capsules compared~     with dummy capsules can reduce the risk of preterm birth, a large study involving~     approximately 10,000 women would be required. But the investigators do not know whether~     women would agree to take part in and complete such a study, and this is what the~     investigators wish to study in the small, initial study described here. The results of this~     study will show whether probiotics produce the desired biological effects on vaginal~     bacteria, and whether it would be feasible to perform the larger, definitive study of their~     effectiveness in prevention of preterm birth.~   "
28036|NCT02690155|"~     To obtain a better understanding on the comparative effectiveness of rivaroxaban versus~     VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial~     fibrillation) in a real-life setting~   "
27835|NCT02692807|"~     The primary aim of this study is to determine the efficacy of hip arthroscopic surgery~     compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and~     radiological findings related to impingement (FAI) and/or labral tears using a randomized~     controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1~     year follow-up)).~      Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy~     than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life~     (iHOT-33) after 1 year and at further (HIPARTI Study).~      The secondary aim of this study is to establish modifiable risk factors associated with~     pain, function, work participation and quality of life over 1 year in people aged 18-50~     years with hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A~     separate paper will be published with this main aim for the HARP Study) Long-term follow-ups~     for HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary~     aims and separate papers).~   "
27836|NCT02692794|"~     Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques~     utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding.~     These methods reduce blood flow to the head and neck area and assist in reducing bleeding~     during surgery but they may predispose patients to cerebral ischemia. Large scale studies~     necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry~     on otolaryngology surgery has not been extensively studied. This study seek to address the~     question of whether cerebral oximetry in the FESS population can help evaluate major and~     minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral~     oximeters are small, noninvasive stickers applied to the forehead of participants and give~     the examiners data regarding the level of oxygen saturation around the brain during the~     course of surgery. During the course of such procedures, where blood flow to the head and~     neck area is intentionally decreased to assist in reducing bleeding during surgery, the~     levels of oxygen saturation around the brain may pose as a predictor or major and minor post~     operative morbidity, as well as the quality of recovery from surgery. Outcome measures will~     include major post operative complications, such as neurological and cardiac complications,~     and minor post operative morbidity, such as length of post anesthesia care unit (PACU)~     length of stay, nausea, and vomiting. Quality of recovery will also be assessed using a~     survey conducted in the PACU and again at the first post operative visit approximately one~     week after surgery.~   "
27837|NCT02692781|"~     MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active~     moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM~     and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The~     peptide is a natural appetite suppressant, secreted by L-cells in the digestive system~     following food intake leading to a decrease in gastric emptying, satiety after crossing the~     blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being~     developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food~     intake and increase glycemic control.~   "
27838|NCT02692768|"~     The purpose of this study is to determine if music therapy interventions as adjunct to~     standard surgical care reduces pre- and post-operative pain and anxiety in patients~     undergoing total shoulder arthroplasty as compared with patients who receive standard of~     care without music therapy.~   "
27839|NCT02692755|"~     This study aims to evaluate the hematological safety of palbociclib with letrozole in~     African American women with hormone receptor positive HER2 negative advanced breast cancer.~     Hematological safety is a composite endpoint of episodes of febrile neutropenia and~     treatment discontinuation due to neutropenia according to current recommendations for~     management of neutropenia~   "
27840|NCT02692742|"~     Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting~     the doses and density of chemotherapy that can be tolerated. The degree and duration of~     neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule,~     has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate~     differentiation of peripheral white blood cells (WBC) and bone marrow cells of the~     leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is~     to determine the safety and effectiveness of Myelo001 in preventing or reducing~     chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due~     to breast cancer.~   "
27841|NCT02692729|"~     This study aims to evaluate the efficacy and safety of transverse supraumbilical incision~     over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.~   "
27842|NCT02692716|"~     This trial is conducted globally. The aim of the trial is to investigate the cardiovascular~     safety of oral semaglutide in subjects with type 2 diabetes.~   "
27843|NCT02692703|"~     The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of~     ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with~     chronic Hepatitis C Virus infection.~   "
27844|NCT02692690|"~     Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart~     failure.~      Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation~     (TENS). It is applied to strengthen the musculature and improve exercise tolerance and~     quality of life.~      It is unclear if application of TENS can cause electromagnetic interference (EMI) in~     patients with Optimizer® pacemaker systems for improvement of heart failure.~      This pilot safety study enrolled 6 patients with chronic heart failure and reduced left~     ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for~     a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to~     the study, and all were in clinically stable condition and willing to participate in this~     study.~      Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF)~     on the right and left musculus trapezius and on both musculi quadriceps femoris. All~     patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery~     of the Optimizer®-system respectively.~   "
27845|NCT02692677|"~     The purpose of this study is to assess the absorption, metabolism, and excretion of~     JNJ-42756493 in healthy male adult participants after administration of a single oral dose~     of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.~   "
28037|NCT02690142|"~     The purpose of this first-in-human study is to investigate the safety and tolerability of~     ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to~     moderate-to-severe psoriasis patients.~   "
27847|NCT02692651|"~     Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure~     in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among~     patients receiving CA, fidaxomicin is superior vancomycin. While these data are encouraging,~     many clinicians remain unclear on how to apply these data to patient care. Additionally,~     patients were excluded from the trials presented to the FDA if it was expected that they~     would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply~     these data to the real world patient who requires a long course of CA and develops CDI while~     on therapy. We therefore propose an open label, comparative and prospective study of~     fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment~     of CDI among patients who are receiving a long course of CA.~      We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure~     for patients with CDI.~   "
27848|NCT02692638|"~     The goal is to assess the appropriateness of the standard practice of a trial of~     nonoperative management for high grade small bowel obstruction (currently up to 72 hours~     based on available literature). The investigator will offer early laparoscopic enterolysis~     (within 24 hours of admission) as the comparator group.~   "
27849|NCT02692625|"~     The purpose of this study is to evaluate the efficacy of probiotic products on~     caries-associated salivary bacterial counts (Streptococcus mutans and Lactobacillus) and its~     effect on dental plaque accumulation in a group of preschool children in Saudi Arabia.~   "
27850|NCT02692612|"~     The purpose of this project is to investigate the age-related differences in force-velocity~     muscle characteristics during isolated knee extensions variable in speed and load, during~     cyclic movements on a usual and recumbent bike variable in speed and velocity development~     and a functional test battery with healthy participants aged between 20-80 years.~   "
27851|NCT02692599|"~     The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated~     mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live~     attenuated mumps vaccine as the control vaccine.~   "
27852|NCT02692586|"~     Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of~     emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.~   "
27853|NCT02692573|"~     Investigators will compare 500 full term babies delivered by SCD randomized into two groups,~     prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse~     oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry,~     respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of~     life; beyond the initial 5minutes of life, monitoring as well as infant's management will be~     done as per current Weiler hospital protocols. The intervention group will be placed in~     prone position for first five minutes immediately after birth, and then changed to supine~     position. The control group will be placed supine from birth. Investigators will check for~     the incidence and severity of RD, supplemental oxygen need and duration, positive pressure~     ventilation (PPV) need and duration or other use of respiratory support (intubation).~     Additionally, investigators will record the number of infants requiring admission to the~     NICU in each group, days of ventilatory support as well as the length of hospitalization.~   "
27854|NCT02692560|"~     The investigators are doing a study to learn how to support patients aged 60+ in taking more~     breaks from sitting and reducing total sitting time. The goal of the study is to find out if~     a sitting time reduction intervention reduces sitting time compared with a control group.~   "
27855|NCT02692547|"~     The purpose of this study is to collect data on the feasibility of the HLCL system in a camp~     setting.~   "
27856|NCT02692534|"~     In this prospective study, investigators plan to evaluate the outcome of general anesthesia~     in the context of patients with a positive cocaine urine test. Patients with a positive~     urine cocaine test who do not appear acutely toxic and have normal vital signs may not have~     an increased rate of perioperative complications during elective surgery compared to similar~     patients with negative urine cocaine screening tests. Patients who are chronic cocaine users~     may have a higher anesthetic requirement.~   "
27857|NCT02692521|"~     The purpose of this study is to discover the incentives and barriers to human milk use and~     breast-feeding in the NICU graduate. By better understanding the incentives and barriers we~     believe we can define better methods for promoting higher rates and longer duration of human~     milk use in this medically fragile population.~   "
27858|NCT02692508|"~     The investigators sought to evaluate the morphological and functional changes and prognosis~     of participants with unexplainable precordial deep T-wave inversion on ECG and with apical~     thickness less than 15mm. The conduction of this study was largely due to the increased~     clinical requirement, which reflected the increased awareness among physicians of missed~     AHCM.~   "
27859|NCT02692495|"~     This study is designed as a prospective cohort study to evaluate the potential of diagnostic~     procedures in defining populations of patients self-reporting unexpected and uncontrollable~     episodes of body odor and/or halitosis. Our initial cohort is generally healthy individuals~     who already underwent multiple diagnostic tests recommended by their physicians and have not~     been diagnosed with any known condition. The investigators will analyze results of~     gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit to~     determine if these tests are useful as potential screening tools for metabolic body odor and~     halitosis.~   "
27860|NCT02692482|"~     The aim of the present study is to assess whether the application of a new hydrocellular~     polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to~     standard care reduces the rate of pressure sores (PU) and their severity especially in the~     elderly population admitted for fragility Hip Fractures.~   "
27861|NCT02692469|"~     Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce~     similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary~     surgical procedure for weight loss in bariatric patients over a 5 year period?~   "
27862|NCT02692456|"~     Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As,~     it has Cross-section imaging system to avoids anatomic structures injury, it has high~     density resolution that clearly display the retro-peritoneal anatomic structures ,it allow~     an optimal puncture site selection and measured the angle and depth of the needle insertion~     accurately with display the range of the neurolytic agent diffusion~   "
27863|NCT02692443|"~     Patients with hypoplastic left heart syndrome and other single right ventricle lesions who~     have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that~     affect quality of life and adulthood employment. This study will leverage the ongoing~     National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction~     Study by using innovative graph measures of brain connectivity to elucidate how alterations~     of the connectome in children with critical congenital heart disease are associated with~     developmental disabilities and their associated clinical risk factors. Improved~     understanding of these interrelationships may facilitate development of targeted~     interventions to improve outcome in the soaring population of adult Fontan survivors.~   "
27864|NCT02692430|"~     The purpose of this study is to perform a multicentre registry of cirrhotic patients who had~     been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI),~     in order to collect anatomical and clinical information. The main objective will be focused~     on the study of portosystemic shunts and their relation with portal hypertension.~      Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010~     to 2014 will be included in the study. The chosen imaging technique will be angio-CT~     preferably, but MRI data will also be available. Patients will be identified in every~     hospital by means of the registry of coded diagnoses and the lists of complementary tests~     performed. Clinical and radiological data of every patient will be collected. The clinical~     variables will be obtained from reviewing the patient clinical history. The radiological~     parameters will be gathered by means of the systematic review of the angio-CT or MRI.~   "
27865|NCT02692417|"~     Female sexual dysfunction, including sexual arousal disorder, has a significant clinical~     impact, affecting millions of women in the United States alone. Peripheral nerve~     stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve~     stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The~     investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural~     circuits and promote improvements in sexual function in women with sexual arousal disorder.~     Subjects will be randomized to receive one of the stimulation approaches. Subjects will have~     weekly 30-minute sessions across twelve weeks.~   "
27866|NCT02692404|"~     In this pilot prospective longitudinal observational study, women who are pregnant and who~     will be experiencing childbirth for the first time will be recruited at the third trimester~     and observed longitudinally for psychiatric and pain characteristics until 3 months~     postpartum. The primary outcome is postpartum depression, assessed by Edinburgh Postnatal~     Depression Scale (EPDS). Infants will also be observed for infant development~     characteristics over time. Women who choose to receive labor epidural analgesia will be~     observed, as well as women who choose to avoid labor epidural analgesia. At baseline, women~     will complete baseline surveys as well as a baseline pain sensitivity test (quantitative~     sensory testing, QST). During labor, they will complete an electronic pain diary delivered~     by a bedside mobile device. Three postpartum assessments will occur over 3 months to assess~     maternal depression, other psychosocial variables, and infant development.~   "
27867|NCT02692391|"~     This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the~     efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ~     failure and mortality in patients with AP and positive SIRS score.~   "
27868|NCT02692378|"~     The purpose of the study is to investigate whether oral sodium bicarbonate supplementation~     to ensure a constant bicarbonate profile in haemodialysis patients will primarily lower~     predialysis potassium levels and secondary lead to improvements in cardiac function, muscle~     mass and dialysis related symptoms.~   "
27869|NCT02692365|"~     This is an exploratory, national, single-center, open-label study, being conducted at the~     Institute of Education and Research of the Syrian-Lebanese Hospital in collaboration with~     the Radiology Institute, the Heart Institute of the Faculty of Medicine of São Paulo,~     Hospital São Paulo UNIFESP, and the Departments of Physics and Mathematics at the University~     of São Paulo in order to detect the presence of calcium flux change, tumor perfusion and~     electrical properties of tumor tissue when exposed to RF EMF AM by Cancer-frequency specific~     in patients with advanced HCC and correlate these findings with hemodynamic changes assessed~     by non-invasive hemodynamic measurements.~      This study aims to demonstrate the presence of three mechanisms (hypothesis) that could be~     involved in the hemodynamic changes and the specific antitumor effect induced by exposure to~     RF EMF AM cancer-specific frequency. This study is not intended to study a therapeutic or~     diagnostic procedure. For this reason, will not be considered evolutionary clinical data~     during and after the intervention of the study.~   "
27870|NCT02692352|"~     The main objective of this study is to examine the effect of Goal Management Training for~     patients with executive difficulties after acquired brain injury in a randomized controlled~     trial. The effect on cognitive functioning will be examined, as will the relationship~     between treatment effects and lesion location and size. The effect of Goal Management~     training on regulating emotions, quality of life and coping will be examined. The~     generalizability of treatment effects across etiologies will be explored by comparing~     effects in three patient groups; traumatic brain injury, cerebrovascular accidents and~     resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of~     white matter connectivity will be used to establish detailed lesion descriptions. Functional~     MRI data will provide information on the neural underpinnings of treatment related change. A~     secondary objective is to expand the Goal Management Training protocol with increased focus~     on emotional regulation and adherence to homework assignment.~   "
27871|NCT02692339|"~     Multicentre, prospective, observational, open-label, single arm, post-marketing study~     intended to record Lenalidomide/Dexamethasone treatment data from patients with~     relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the~     standard clinical practice and approved Summary of Product Characteristics (SmPC).~   "
27883|NCT02692183|"~     A cornerstone in PD and ET research is the investigation of neurophysiological changes as~     potential bio-markers that could help in tracking disease progression and response to~     therapy. Electroencephalography (EEG) could provide a non-invasive and relatively~     inexpensive tool for identification of such bio-markers. In this study the investigators~     will use high-density electroencephalographic (EEG) recordings, in order to develop a~     platform of sensitive and reliable bio-markers for disease progression and response to~     MR-guided Focused ultrasound thalamotomy (FUS-T) intervention for tremor.~   "
27872|NCT02692326|"~     The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus~     continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary~     aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital~     stay, mortality, nutritional status at two years of chronological age and predisposing~     factors to the development of parenteral nutrition associated cholestasis (PNAC) between the~     two groups, and to evaluate the adverse effects of the method of cycling used.~      This was a single-center, prospective randomized not blinded study was conducted in a level~     3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic~     instability until a stable situation, congenital hepatic disease, preterm infants with~     diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of~     authorization from the parents or guardians were excluded.~   "
27873|NCT02692313|"~     Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer~     duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo~     endothelial function and atherothrombotic balance in humans. The specific aim of our study~     will be to determine the dose response effects of the key ANS counterregulatory hormone~     epinephrine on endothelial function, fibrinolytic balance and pro-atherogenic inflammatory~     mechanisms in healthy humans.~   "
27874|NCT02692300|"~     This study examines the potential link between deep levels of anesthesia and delirium.~   "
27875|NCT02692287|"~     The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been~     developed as a treatment method for PPH. It will be used to stop the bleeding through~     compression of the uterus of women having a PPH. It will be markedly easier to undertake~     than traditional bimanual compression, whilst also being significantly more acceptable to~     women themselves. Use of the PPH Butterfly will provide an alternative management option for~     PPH and in some cases should avoid the need for women to have to go to theatre for~     treatment. This research will allow the investigators to determine if they have the optimum~     size and shape of the device, that it will operate as intended when compressing the uterus,~     and to gauge its acceptability to participants and users. In phase I the investigators will~     recruit healthy volunteers i.e. women who have delivered their baby vaginally following~     Induction of labour (IOL) however these women will not be experiencing a PPH. The device is~     to be assessed purely on size, usability and acceptability not for diagnosis or as a~     treatment method. Following the delivery participants will be invited to have the PPH~     Butterfly inserted vaginally for an average of 2 minutes. It is through this that the~     investigators will assess the suitability of the device in its current design, when it is in~     practice. The clinician who operates the device will complete a Likert scale questionnaire~     along with some open questions following each administration. Participants will also answer~     a short questionnaire. .~   "
27876|NCT02692274|"~     Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in~     resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South~     Africa during the last 10-15 years. The investigators sought to determine the existing~     availability, current usage and future need of POC tests among rural primary healthcare~     (PHC) clinics in South Africa's KwaZulu-Natal Province.~   "
27877|NCT02692261|"~     Sinus augmentation is a predictable method when alveolar bone height is not sufficient for~     dental implant placement in posterior maxillary alveolar region..The aim of this~     prospective, randomized, controlled clinical study is comparison of hyaluronic acid~     originated matrix and equine derived xenograft with only xenograft use in sinus augmentation~     by micro computed tomography and histomorphometry.~   "
27878|NCT02692248|"~     The use of highly effective rituximab-containing therapy for treating diffuse large B-cell~     lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In~     addition, patients with advanced age or significant comorbidities, who are consequently not~     candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective~     studies investigating new salvage regimens are essential.~      The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage~     regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile~     for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is~     a potent killer of ABC DLBCL cell lines in vitro and in xenografts.~      It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and~     well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II~     trial, to investigate the safety and efficacy of the combination of ibrutinib with~     rituximab, gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as~     salvage therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to~     stem cell transplant.~   "
27879|NCT02692235|"~     Research project objectives~      The primary aims of the current research project are:~        1. To investigate the effects of carnitine with leucine supplementation, in comparison to~          carnitine supplementation alone, on muscle strength and body composition;~        2. To use carnitine supplementation as the anti-inflammatory intervention for exploring~          the relationship between inflammation and associated with aging reduction of skeletal~          muscle mass;~        3. To explore whether nutritional supplementation and resistance training might be~          combined to produce synergistic effects in prevention of muscle loss during aging;~      Hypothesis~        1. Leucine stimulates carnitine transport into the muscle cells, which improve~          mitochondrial capacity. Modification in energetic of skeletal muscle affects the body~          composition and muscle performance;~        2. The carnitine supplementation modulates the blood cytokines concentration.~          Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated~          with aging;~        3. Resistance training combined with nutritional supplementation have more beneficial~          effect than resistance training alone in prevention of muscle loss during aging;~   "
27880|NCT02692222|"~     This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac~     Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV~     and CO calculated by thermodilution.~   "
27881|NCT02692209|"~     The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm~     FFDM plus DBT versus FFDM alone in the detection of breast cancer.~   "
27882|NCT02692196|"~     Real-time fMRI neurofeedback training induced volitional control of brain activity and~     connectivity could help individuals to gain better control over their emotions.~   "
27886|NCT02692144|"~     This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made~     through a proprietary baking process combined with slow digestible carbohydrates and fiber~     will elicit lower postprandial blood glucose and insulin responses than a Control-cluster~     made from general processing procedure and with typical ingredients commonly used in~     commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the~     Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the~     postprandial responses elicited by the Test-cluster was also compared with those after a~     portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25~     healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with~     fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the~     Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at~     intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained~     similar amounts of total carbohydrates, protein, fat and energy content. Each serving of~     Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.~      On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by~     finger-prick 5min apart and after the 2nd sample, the subject started to consume a test~     meal. Subjects were asked to consume the entire test meal within 10 min. At the first bite a~     timer was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40,~     50, 60, 90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a~     separate vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood~     samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to~     each sample. During the 4hr of the test, participants remained seated quietly. After the~     last blood sample participants were offered a snack and then allowed to leave.~   "
27887|NCT02692131|"~     There is an increasing need for diagnostic modalities able to objectively quantify~     myocardial function. Quantification of regional myocardial function with ultrasound is~     challenging on its own. Visual assessment of wall motion and thickening requires extensive~     training [1] and remains highly subjective [2]. Tissue deformation imaging is a recently~     introduced technique which enables the objective assessment of regional myocardial~     deformation assessed by ultrasound based strain and strain rate using Doppler Tissue Imaging~     or Speckle tracking. There are limited number of studies comparing the myocardial~     deformation parameters (i.e. Strain and Strain rate) by 2 different echocardiographic~     techniques viz Doppler tissue imaging and Speckle tracking in the perioperative period. In~     this study, we plan to study the above said parameters in patients undergoing coronary~     artery bypass grafting using transesophageal echocardiography and correlate these parameters~     with cardiac output by thermodilution method using pulmonary artery catheter.~   "
27888|NCT02692118|"~     Sepsis is still a challenge for clinicians since the detailed pathomechanism are still~     unknown and until now early markers for sepsis are not defined yet. Immunological pathways~     and new mediators defined in animal models are not yet investigated in patients with sepsis.~     Therefore the investigators will measure new mediators in patients with septic shock.~   "
27889|NCT02692105|"~     This study will offer men with intermediate risk prostate cancer who are suitable for, and~     interested in, prostate brachytherapy, the opportunity to be randomized between low dose~     rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current~     standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also~     available as a standard of care in BC but only when used as a boost in addition with~     external beam radiotherapy. In addition, men will be offered the opportunity for testing the~     aggressiveness of their cancer using Cell Cycle Progression Gene Profile.~   "
27890|NCT02692092|"~     HealthEast Care System began the first community-based joint replacement registry (HJRR) in~     the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the~     HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery~     by providing timely information to their surgeons and the broader orthopaedic community.~      As it moves into the third decade, the HJRR is proud of its role in the development of the~     national American Joint Replacement Registry (AJRR) and will remain an important contributor~     to the larger national effort in the advancement of orthopaedic science.~   "
27891|NCT02692079|"~     This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF)~     treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony~     defects of patients with chronic periodontitis. In each patient, the infrabony defect of one~     side of arch was designated as control group (allograft), while the infrabony defect on the~     contralateral side of same arch was designated as test group (allograft+T-PRF).~   "
27892|NCT02692066|"~     Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant~     recipients. Current recommendations suggest a 4 week waiting period between vaccination and~     transplantation and consideration of booster immunizations if antibody response does not~     reach target levels. This four week waiting period can result in delayed transplant,~     rejection of an optimal organ, or missed opportunity to vaccinate. However, these~     recommendations are not evidence based.~      This is a prospective study to look at the immune response to varicella vaccine in children~     with chronic liver disease.~      Investigators will evaluate:~        1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after~          vaccination in children with chronic liver disease and~        2. the difference in humoral and cell mediated immune response to varicella immunization~          between children with chronic liver disease and healthy children.~   "
27893|NCT02692053|"~     Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of~     inflammation, which could lead either to hypercoagulability or hypocoagulability. It is~     currently not possible to determine the hemostatic status of a given patient. This~     instability of hemostatic system is not revealed by classical tests. Thus, a better~     characterization of hemostatic status could certainly improve patient care. This study aims~     at characterizing disorders of coagulation and fibrinolysis using global tests such as~     thrombin generation test or coagulolytic test. Furthermore, the association with biological~     markers of interest (such as microparticles, neutrophil elastase or histones) will be~     evaluated.~   "
27894|NCT02692040|"~     A randomised, placebo controlled Phase I study to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of G3215 in adult subjects.~   "
27904|NCT02691910|"~     This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone~     compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused~     by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin~     of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was~     28 days. The duration of complete follow up to detect recurrent P. vivax infections by~     passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ~     treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.~   "
27905|NCT02691897|"~     The aim of this study is to assess the efficacy and safety of melatonin in control of blood~     sugar in patients with type 2 diabetes mellitus (DM).~   "
27895|NCT02692027|"~     The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural~     Lesotho. Participants who were tested HIV-positive during community-based HIV testing and~     counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1~     with parallel assignment.~      Participants in the control arm follow the standard of care after a community-based HIV test~     result: They are referred to the nearest clinic where they will receive baseline laboratory~     testing and adherence counseling. After at least 2 clinic visits for adherence counseling~     they can start anti-retroviral therapy (ART). After ART-initiation they have to attend~     monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention~     arm are proposed same day community-based ART initiation combined with less frequent~     follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression~     at 12 months after having tested HIV-positive during the community-based HIV testing and~     counseling campaigns.~   "
27896|NCT02692014|"~     Coronary drug-eluting stent (DES) has been launched in China for more than ten years.~     Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit~     the progression of atherosclerosis plaque outside segments. It was shown that the~     progression rate of non-target atherosclerosis plaque for patients with DES implantation was~     6-10%, which indicated that current secondary prevention for coronary heart disease (CHD) is~     far from the achievement of ideal conditions.~      Atherosclerosis has many risk factors based on current CHD guidelines, among which the level~     of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on~     statins were performed in the world during the past 20 years. It was demonstrated in these~     studies that statins were significant to both primary and secondary preventions of CHD.~     What's more, the lower of LDL level is reached, the lower incidence of clinical~     cardiovascular events is achieved. However, cardiovascular events were still not avoidable~     especially for the secondary prevention of CHD even if the level of LDL was significantly~     controlled under the recommended range of guidelines by high dosage of statins.~      It was shown in some recent studies that high loading dosage of statins may effectively~     control the progression of coronary plaque. However, multiple studies found it was hard to~     control the progression of all patients of coronary plaque due to individual difference.~      Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of~     all statins because of possible high safety issues and confusions about the appropriate~     application in Chinese patients, as well as economy burden to Chinese patients with high~     treatment cost. How to evaluate individual progression risk of coronary plaque and enhance~     risk factors control and the treatment of statins for necessary population, is currently an~     issue, which should be solved in the diagnosis and treatment of CHD.~      The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on~     the decrease of LDL. Large number of studies found other risk factors. For instance,~     diabetes and chronic kidney diseases may also be associated with the progression of plaque.~     However, the potential impact and control are still uncertain up to date.~      Based on these background, we design a retrospective study, Risk Factors Promoting Coronary~     Plaque Progression In China (The RIPPER Study), to solve these issues.~   "
27897|NCT02692001|"~     Childhood obesity is a major problem in Canada. Children are eating larger portions and have~     easier access to high-fat, high-sugar foods and drinks. Menu labelling is a promising tool~     to teach families about healthier choices. The investigators will study the impact of~     combining child-friendly superhero food labels, fun food names, and a traffic light system~     on the food choices of children and their parents at SickKids. The investigators will use~     the hospital inpatient food ordering system (Meal Train) and look at food orders and eating~     patterns before and after introduction of the revised Meal Train menu. Only the design~     format of the menu was changed and all menu items remained unchanged. The investigators will~     also survey the families on their thoughts about the menu. This study will help doctors and~     dietitians develop strategies to deliver nutrition education to families.~   "
27898|NCT02691988|"~     Rationale: Because long-term use of ICS is associated with an increased likelihood of~     side-effects such as increased risk of pneumonia and loss of bone density, it is important~     to limit prescription of ICS to patients who have a clear indication for this treatment. In~     addition, avoiding unnecessary treatment with ICS could reduce the burden that chronic~     obstructive pulmonary disease (COPD) puts on healthcare budgets. The recently updated COPD~     guideline of the Dutch college of General Practitioners (NHG) emphasizes the importance of~     optimizing medical treatment for COPD patients with only limited room for the use of inhaled~     corticosteroids.~      Objective: The objective of the study is to investigate whether discontinuation of inhaled~     corticosteroids (ICS) for patients without a clear indication for ICS according to current~     guidelines results in a reduction of ICS use without adverse health effects for the patients~     involved.~      Study design: The study is a pragmatic, clustered, parallel group, non-inferiority trial in~     Dutch general practices with a follow-up of 26 weeks per patient.~      Study population: 620 COPD patients with confirmed chronic airflow obstruction, aged ≥ 40~     yrs who use ICS for at least the prior 6 months without a clear indication.~      Intervention (if applicable): Guided ICS withdrawal in optimised COPD management. All study~     participants (of both study arms) will receive recommendations on optimal bronchodilator~     therapy and a personalized action plan to recognize symptom deterioration in an early stage.~      Main study parameters/endpoints: Number of exacerbation-free weeks. Secondary study~     parameters: successful cessation of ICS, time to first exacerbation, number of moderate and~     severe exacerbations, health-related quality of life, health status, and pneumonias.~     Moreover, information on the process of care and costs will be collected.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Many COPD patients use ICS without a clear indication. Long-term use of ICS is~     associated with an increased likelihood of side-effects such as increased risk of pneumonia~     and loss of bone density and should be avoided in those who do not benefit from it. However,~     there is a small subgroup of COPD patients that have reduced numbers of exacerbations~     because of their ICS use and it is impossible to identify a priori the patients who this~     applies too. Therefore, it is important that the ICS discontinuation is guided to detect~     potential deteriorations early on.~   "
27899|NCT02691975|"~     This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in~     patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will~     receive SHR3680.~   "
27900|NCT02691962|"~     This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral~     or incisional midline hernia repair in patients across all wound classes (All Comers)~     through 24 months post repair.~   "
27901|NCT02691949|"~     Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality~     of life in patients with Sjogren's syndrome. Mycophenolate also has excellent~     immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus~     nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil~     could be used to improve ocular dryness and oral dryness in patients with Sjogren's~     syndrome.~   "
27902|NCT02691936|"~     This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2~     fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of~     vulvovaginal atrophy/GSM.~   "
27903|NCT02691923|"~     This clinical research will evaluate the diagnostic potential of fluorescein as visualized~     through an operating microscope relative to 1) contrast enhancement on co-registered~     preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard~     histology obtained from biopsy sampling during the procedure.~      Subjects will include those people with operable brain tumor with first-time presumed~     pre-surgical diagnosis of high-grade glioma or low-grade glioma.~   "
27906|NCT02691884|"~     The aim of the study is to assess the change of fetal heart rate in response to the amount~     of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using~     an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).~   "
41137|NCT02518568|"~     The purpose of this study is to investigate the pharmacokinetics of serum iron after a~     single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron~     deficiency anaemia.~   "
27908|NCT02691858|"~     Intussusception is one of the most frequent causes of acute bowel and second most common~     cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are~     either due to pathological lead point or post operative. Treatment of intussusception must~     start with medical resuscitation, then radiological or operative reduction of~     intussusception.~      Our surgery team has used hydrocortisone with the medical resuscitation to improve the~     success rate of pneumatic reduction and decrease the number of reduction trials.~   "
27909|NCT02691845|"~     The investigators propose a randomized clinical trial in which 240 depressed individuals are~     assigned to one of three arms, with each successive arm having an added component that may~     serve to increase and maintain physical activity:~        1. brief advice (BA) to exercise (control condition);~        2. BA + supervised & home-based exercise (SHE) + health education (HE) contact control;~          and~        3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise~          (CBEX).~      The primary aim is to assess and optimize the safety, feasibility, acceptability of each~     intervention component, as well as barriers limiting their effectiveness in order to prepare~     for a larger scale randomized clinical trial.~   "
27910|NCT02691832|"~     The Double Sensor examined in this trial was developed by Dräger Company and is a novel non-~     invasive device for assessing core body temperature. In a preliminary research investigators~     have conducted the Double Sensor was found promising for potential use of physiological heat~     stress early detection. This follow-up experiment was designed to validate the data during~     high and changing body core temperatures and to examine the Double Sensor performance while~     integrated into a helmet as in intended application.~   "
27911|NCT02691819|"~     At the same time in the side branch stent expansion vessels were embedded and balloon~     dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of~     interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h,~     24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme~     (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine~     months after surgery, coronary angiography, quantitative coronary angiography, evaluation of~     each main branch and side branch of the lesion degree of stenosis (determination of~     bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade;~     using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side~     branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel~     diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months~     follow-up. Cardiovascular events included total cause of death, cardiac death, total re~     hospitalization rate, recurrent myocardial infarction or unstable angina.~   "
27912|NCT02691806|"~     Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that~     follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ~     damage, muscular damage and / or in different tissues of the body. In this study,~     investigators aim at developing new indexes, based on hemodynamics measurements from the~     peripheral micro - circulation system, for the benefit of early detection of fatigue during~     accelerated physical activity.~   "
27913|NCT02691793|"~     This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive,~     FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib~     by Avatar scan that has progressed following standard therapy or that has not responded to~     standard therapy or for which there is no standard therapy.~      To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.~   "
27914|NCT02691780|"~     This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation~     Refractory solid tumor and specific sensitivity to Sorafenib by Avatar scan that has~     progressed following standard therapy or that has not responded to standard therapy or for~     which there is no standard therapy.~      To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.~   "
27915|NCT02691767|"~     This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification~     Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has~     progressed following standard therapy or that has not responded to standard therapy or for~     which there is no standard therapy.~      To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.~   "
27916|NCT02691754|"~     Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but~     it is not included in list of drugs than can be prescribed in charge of National Health~     System by General Practitioners. The hypothesis is that removing this economical barrier the~     investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors~     (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary~     outcome, opioids use was also monitored to see.~      Aim of the study is to test if allowing prescription of free paracetamol decreases the~     prescription of NSAID in osteoarthritic patients.~   "
27917|NCT02691728|"~     This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in~     patients with Chronic GT1 or GT4 HCV infection and autoimmune disease~   "
27918|NCT02691715|"~     Investigator will examined the diagnostic effect of the endometrial washing by saline.~     Because this technique more less painful and easier compared to endometrial curettage.~     Participants will separate into two groups. In study groups before endometrial curettage 5~     cc saline infused to the endometrial cavity then aspirate and put into thin prep to~     examined. After this procedure routine endometrial curettage will be done. In control group~     only endometrial curettage will be done. Pathologic results of thin prep and curettage will~     compared.~   "
27919|NCT02691702|"~     This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult~     and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK)~     and pharmacodynamics (PD) of PF 05251749~   "
27957|NCT02691208|"~     The patients were divided into two randomized groups with 24 patients per group, which were~     given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30~     minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes~     acupuncture using predefined points.~      The patients were assessed at baseline, after five weeks and at the end of 10 weeks.~     Responded to an evaluation form about their registration and social data. The physical~     examination included the assessment of shoulder range of motion, shoulder muscle strength,~     circumference of the upper limbs and the presence of pain. Questionnaires of quality of~     life, upper limb function and depression.~   "
27920|NCT02691689|"~     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is~     associated with considerable morbidity and even mortality.~      Next to environmental risk factors, the investigators believe that there is an important~     role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between~     the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The~     investigators hypothesize that the genotype is partly responsible for the phenotypic~     variability in patients with congenital shunt lesions, where some develop PAH and others do~     not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening~     could be a useful additional tool for early detection of patients at risk of pulmonary~     vascular disease and PAH development, with new opportunities for prevention or early~     treatment.~   "
27921|NCT02691676|"~     Introduction: The strategy of perioperative fluid therapy has an important impact not only~     on the circulating volume and perfusion of organs and tissues but also on the patient's~     internal environment. The study aimed at comparing the effects of perioperatively~     administered balanced crystalloid infusion solutions containing different amounts of~     metabolizable anions on homeostasis.~      Methods: In the prospective randomized study, patients were assigned to Plasmalyte (PL) and~     Ringerfundin (RF) Groups after their postoperative transfer to an intensive care unit (ICU).~     The infusion solutions were parenterally administered at 1000 mL/6 hours. Arterialized~     capillary blood was sampled at the time of transfer to the ICU (Time 0), and again at 2~     hours and 6 hours from Time 0. The collected blood was tested for blood gas parameters using~     the Astrup method.~   "
27922|NCT02691663|"~     The purpose of this research study is to determine the effect of a bicarbonate supplement on~     kidney function and physical function.~   "
27923|NCT02691650|"~     Goal of this study is to measure serum cholinesterase activity in patients with traumatic~     and/or burns injury admitted to the emergency room by using point-of- care-test system~     (POCT). Serum cholinesterase activity, measured using POCT system, might play an important~     role in the early diagnosis and prediction of patient outcome in trauma-induced systemic~     inflammation.~   "
27924|NCT02691637|"~     Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic~     gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal~     metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori~     eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia~     has not been clearly defined. The aim of the present study was to investigate the~     relationship between H. pylori eradication and the reversibility of atrophic gastritis and~     intestinal metaplasia in Korean patients.~   "
27925|NCT02691624|"~     Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study,~     it is used to investigate the imaging characteristics of patients'upper limb lymphatic~     drainage before operation, and the influence of operation on it.~   "
27926|NCT02691611|"~     The investigators hypothesize that environmentally influenced histone modifications regulate~     AM mediated inflammation, contributing to a variable clinical course of AATD, and may also~     influence or be influenced by the activity of AAT augmentation therapy.~   "
27927|NCT02691598|"~     Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of~     pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or~     parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2~     adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators~     aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous~     system, thus relieve inflammation response.~   "
27928|NCT02691585|"~     Blood pressure (BP) reduced significantly after listening to Indian music among~     prehypertensives and hypertensives in all subjects who were given a musical piece composed~     on raga 'bhimpalas' (raga that normalizes BP) to be heard daily for 3 months. On~     retrospection into the methodology, the effect of a single raga (Bhimpalas) alone had been~     tested. Heart rate variability (HRV) recorded once on recruitment and followed up after 3~     months failed to show any change. The acute effect of music on HRV while listening to raga~     bhimpalas, and the effect of all ragas listed in Gandharva veda had not been tested.~     Respiratory rate was not controlled (affects HRV) and EEG waves were not studied.~   "
27929|NCT02691572|"~     The study will compare the analgesic efficacy of transversus abdominis plane block and wound~     infiltration in parturients undergoing cesarean delivery under spinal anesthesia.~   "
27930|NCT02691559|"~     Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as~     PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of~     AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract,~     umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like~     peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin,~     sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying~     levels of these molecules relevant to the stage of lung maturation may constitute an~     association to AF pHTo detect the possible effect of AF pH on neonatal respiratory~     morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes.~     pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of~     NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of~     morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn~     (TTN) are all recorded.~   "
27931|NCT02691546|"~     The SCOPE study is an observational, multicenter, prospective cohort study aimed at~     evaluating a 2-year screening programme for CKD in a population of older patients, aged 75~     years or more, in seven European Countries, in an attempt to investigate whether and to~     which extent currently available screening methods may identify older people at risk of~     worsening kidney function.~   "
27958|NCT02691195|"~     Regional anesthesia improves quality of recovery after surgery in many studies.~     Ultrasound-guided serratus plane block is a novel technique which may be a viable~     alternative to current regional anesthetic techniques. This randomized, controlled trial is~     to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after~     breast tumor resection.~   "
28038|NCT02690129|"~     The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the~     treatment of threatened miscarriage. All eligible pregnant women will be randomized to~     either receive vaginal progesterone or no treatment.Evaluation will be two weeks after~     intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.~   "
27932|NCT02691533|"~     Study population: Patients admitted or seen in OPD (Out Patient Department), Department of~     Hepatology.~      Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017~     Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3~     PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).~      Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).~      Group C -Placebo group~      Monitoring and assessment- :- The following tests will be done in these patients:-~        1. Complete clinical examination.~        2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels~        3. BUN (Blood Urea Nitrogen)~        4. Serum free fatty acid levels~        5. Lipid profile.~        6. Arterial ammonia~        7. Arterial lactate~        8. Blood sugar and serum insulin levels~   "
27933|NCT02691520|"~     The purpose of this study is to assess the epidemiology of Treatment Resistant Depression~     (TRD) in the nationally insured population in Taiwan including incidence, duration of~     clinical episodes, and prevalence by age and sex.~   "
27934|NCT02691507|"~     The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC)~     1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.~   "
27935|NCT02691494|"~     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in~     combination with estradiol/norethindrone acetate for the management of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
27936|NCT02691481|"~     Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical~     nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and~     enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma~     glucose is not yet known.~      The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma~     glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty~     acids (FFA) and serum triglycerides (TG).~   "
27937|NCT02691468|"~     The purpose of this study is to compare difference of displacement between Polyvinyl~     Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position~     from supine to lateral in thoracic surgery.~   "
27938|NCT02691455|"~     Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt~     implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.~   "
27939|NCT02691442|"~     Several reports have compared the duration of action of levobupivacaine and ropivacaine as~     local anesthetic. The most widely used method for sensory function evaluation is though~     means of a pinprick test. The investigators want to use the novel method of Quantitative~     Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold~     sensation to assess small nerve fiber function. The investigators will assess the duration~     of action of different drugs when used in an inter scalene nerve block in patients scheduled~     for shoulder surgery.~   "
27940|NCT02691429|"~     Our research group tested the toxicity of different dye concentrations extracted from the~     acai fruit using a rabbit model. The dye extracted from the acai fruit in concentrations of~     10% and 25% was found to be safe for vitreoretinal surgery. This initial research~     represented the landmark research for testing this alternative vital dye in a clinical~     research in humans.~      The aim of the present clinical trial in humans will be to test the applicability of the~     acai dye in the identification of the posterior hyaloid and ILM during vitreoretinal surgery~     in humans.~   "
27941|NCT02691416|"~     The purpose of this study was to evaluate differences between propofol postconditioning and~     sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.~   "
27942|NCT02691403|"~     Patients undergoing abdominal procedures often require multimodal postoperative pain~     controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a~     part of it. The investigators hypothesized that the ultrasound-guided QL block with~     transmuscular approach can provide adequate pain relief for colostomy closure as part of a~     multimodal pain control.~   "
27943|NCT02691390|"~     dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent~     for at least two weeks.~   "
27944|NCT02691377|"~     The purpose of this study is to determine whether acupuncture is effective and safe in the~     treatment of Primary Sjögren Syndrome.~   "
27945|NCT02691364|"~     Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is~     necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in~     reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and~     preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T~     cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory~     cells are not known. The main objective of this study is to analyze the effect of~     preeclampsia on levels of immune cells.~   "
27946|NCT02691351|"~     The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing~     effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about~     conical features and treatment outcomes of each subtype should be accumulated to establish~     treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma~     was from small case series of single institute. Furthermore, as novel drugs were developed~     for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were~     treated with those novel drugs are especially required because their outcomes may reflect~     the outcomes of currently available treatments. Thus, a multinational, multicenter~     prospective registry study is needed to provide information useful for establishing~     treatment strategies for T-cell lymphoma.~   "
27959|NCT02691182|"~     Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid~     with ADHD and have participated in the 810P301 or 810P302 study are invited to participate~     in this study. This is a Phase 3 open label extension (OLE) study with the objective of~     collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in~     pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After~     confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be~     given a choice to extend participation in this study every 6 months for up to 36 months.~   "
28657|NCT02682043|"~     The purpose of this study is to investigate parental attitudes towards their child who has a~     mobility impairment, to using a modified electric toy car, and to evaluate from their~     perspective, if it facilitated social interaction for their child with mobility impairment.~   "
27947|NCT02691338|"~     The incidence of perioperative stroke in the non-cardiac, non-vascular, non-neurological~     high risk surgical population is 2%. It is higher (~5%) for cardiac surgery and carotid~     endarterectomy patients, with a stroke associated mortality of up to 60%. These patients~     could be immediately treated if their condition was detected on time. Currently, there is no~     standard brain monitoring procedure for anaesthetised patients. The purpose of the proposed~     study is to optimize and validate an online monitor for neurological deterioration under~     anaesthesia based on an easily operatable EEG system comprised of 4 electrodes, a reference~     electrode and a newely developed algorithm for analyzing the EEG signal. The monitor aims at~     generating an immediate warning at the onset of neurological deterioration. For the purpose~     of technology development with a minimal sample size, it is necessary to select a patient~     population that demonstrates significant neurological dynamics under anaesthesia. We will~     therefore focus on anesthesized patients undergoing neurovascular thrombectomy after CVA.~   "
27948|NCT02691325|"~     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta~     inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment~     of inflammatory airway diseases. The study will be conducted at a single centre and in 3~     Parts. The aim of Part A and B of the study are to assess the safety, tolerability and~     pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557~     administered via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first~     study in which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will~     investigate the proportion of the systemic exposure that post inhalation is due to the~     swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA~     device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C~     may be run sequentially or in parallel. Part A is a randomized, double blind, placebo~     controlled, single dose, dose escalating incomplete block 2-period crossover study in~     healthy subjects. Subjects will be randomized to receive either one dose strength of~     GSK2269557 and placebo utilizing placebo replacement, or will receive both active dose~     strengths. Part B is a randomized, double blind, placebo controlled, repeat dose study in~     healthy Subjects. Subjects will be randomized to receive either repeat doses of GSK2269557~     or placebo for 10 days. Part C is a, randomized, open-label, crossover design to assess the~     systemic exposure of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy~     subjects, with and without ingestion of activated charcoal. ELLIPTA is the registered~     trademark of GlaxoSmithKline groups of companies.~   "
27949|NCT02691312|"~     Diabetic retinopathy (DR) causes more new cases of blindness among young adults than any~     other disease. More than 90% of individuals with type 1 diabetes (T1D) will have some form~     of DR by 20 years after their diagnosis. DR is associated with long-term hyperglycemia and~     blood glucose variability, which induces vascular endothelial dysfunction and destruction in~     the retina, eventual retinal ischemia, and in the end, widespread neovascularization of the~     retina and optic disk. When these fragile vessels bleed, they can cause vitreous hemorrhage~     and loss of vision. Eventually the friable vessels fibrose and can result in retinal~     detachment or further retinal ischemia.~      Major risk factors for the development of diabetic retinopathy are time since diagnosis, age~     at diagnosis, and severity of hyperglycemia. Retinopathy most commonly occurs at least three~     years after diagnosis and most cases are diagnosed more than five years after the onset of~     T1D. Current guidelines from the American Diabetes Association (ADA) and American Academy of~     Ophthalmology (AAO) recommend that patients with T1D undergo an initial comprehensive~     dilated fundoscopic evaluation once the individual has had diabetes for 3-5 years and has~     either reached puberty or 10 years of age, whichever is earlier. These patients should~     receive a yearly exam thereafter, or every two years based upon the recommendation of an eye~     care professional. However, the prevalence of retinopathy in children is unknown and~     adherence to these guidelines, especially in youth, has proven difficult. Thus, it is~     important to make these guidelines more evidence based, as retinopathy is often asymptomatic~     until vision loss occurs. The first step in this process is the determination of the~     prevalence of retinopathy in a general population of youth with diabetes. This should be~     followed by determining which children are most at risk, so the guidelines can provide~     realistic and pertinent guidance to practitioners.~   "
27950|NCT02691299|"~     Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3~     consecutive weeks followed by one-week off to evaluate the survival benefit of patients with~     advanced non-squamous NSCLC treated with Fruquintinib.~   "
27951|NCT02691286|"~     The aim of the study is knowing the prognostic value of circulating miRNAs in patients~     admitted to our hospital with STEMI complicated with cardiogenic shock.~   "
27952|NCT02691273|"~     It was found that an important part of the factors impeding adherence to medication and a~     healthy lifestyle among the chronically ill diabetic patients lies in proper management of~     the disease. Since it is a chronic progressive disease the caregiver is the patient~     himself.Studies have shown that software system, sending text messages / messages /~     reminders daily and answering questionnaires can improve adherence to a change in lifestyle.~      This study is an initial pilot study , which examines Feasibility ( Applicability ) of using~     a smart application that promotes a healthy lifestyle perseverance parallel use relaxation~     techniques .~   "
27953|NCT02691260|"~     The purpose of this study is to determine the feasibility of providing incentives to people~     enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.~   "
27954|NCT02691247|"~     This clinical trial will explore the safety and effect of autologous ex vivo expanded~     polyclonal regulatory T-cells on beta cell function in patients, aged 12 to 17, with recent~     onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM~     will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or~     low dose) or placebo.~   "
27955|NCT02691234|"~     Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation~     for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves~     of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the~     use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion~     rate, increased cell proliferation and cell activity and decreased cell apoptosis.~      The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave~     treatment will be done together with the standard conventional treatment for DFUs, compared~     to a control group who will receive the same conventional standard of care.~   "
27956|NCT02691221|"~     The purpose of this study is to increase use and availability, as well as assess the~     feasibility of the ReliefLink (RL) application for use in conjunction with standard care to~     promote psychological health and prevent suicidal behavior.~   "
29140|NCT02675712|"~     This pilot study evaluated whether participating in an African drumming activity for 45~     minutes immediately improved mental well-being among 13 adults diagnosed with acute mood~     disorders who were attending a private mental health clinic. The drumming intervention was~     completed by occupational therapists.~   "
27960|NCT02691169|"~     There are several new therapies available to treat men with advanced prostate cancer;~     however, the decision making tools needed to determine the best treatment for these patients~     are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being~     recognized as an important target for prostate cancer imaging and determining the most~     effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One~     of these agents is 18F-DCFPyL. In this study the investigators will image men with advanced~     prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT)~     scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection~     of metastases and monitoring the effects of therapy with conventional imaging (CT, bone~     scan) and clinical follow-up. In this way, the investigators will evaluate the benefit of~     using 18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with~     advanced prostate cancer.~   "
27961|NCT02691156|"~     Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the~     intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific~     total bilirubin level and need for intervention has been elusive. This is most likely due to~     other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even~     interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy~     has impacted clinical and family-centered care, and in the extreme preterm infants, it may~     have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy~     in in order to reduce its use is unique. The investigators have assembled a~     transdisciplinary team to examine critical unanswered questions including the role of~     bilirubin binding capacity (BBC) of an individual during the first week of life in the~     context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic~     disorders, that includes neuro-anatomical, hearing, visual and developmental processing~     impairments. In this study, the investigator will evaluate two new innovative nanotechniques~     to quantify bilirubin load for the first time in the context of a clinical decision~     algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The~     investigators anticipate that knowledge gained from this study will lead to ethically~     testable hypotheses to individualize the prescription of phototherapy.~   "
27962|NCT02691143|"~     The purpose of this study is to determine if post-manipulation elastic therapeutic tape~     (ETT) with TheraBand® Kinesiology Tape to neck pain patients can impact neck range of motion~     (ROM) and post-manipulation pain. A convenience sample of 50 patients, between the ages of~     18-64, who present with acute non-complicated postural neck pain will be recruited from an~     outpatient chiropractic clinic. Upon providing consent to participate, patients will be~     randomly assigned into 2 groups; Control Group (manipulation only) and Tape Group~     (manipulation plus tape). Pain and neck ROM will be recorded at 3 different intervals: (1)~     pre-cervical manipulation, (2) within 5 minutes of cervical manipulation, (3) with 24-48~     hours after manipulation.~   "
27963|NCT02691130|"~     Multimeric-001 (M-001) contains conserved, common linear influenza epitopes that activate~     both cellular and humoral arms of the immune system against a wide variety of influenza A~     and B strains. Apart from its direct action, M-001 is an attractive candidate for priming~     immune responses to pandemic influenza vaccine in the adult population. The current clinical~     study was designed to assess M-001's standalone and priming action in subjects aged 18-60~     years old.~      This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to~     receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two~     placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.~   "
27964|NCT02691117|"~     Management of pediatric alopecia is particularly challenging given the chronicity of the~     condition, limited therapeutic response and devastating psychological effects. There is a~     paucity of safe and effective therapies in this population.~      The investigators propose to conduct and open label, prospective cohort pilot study using~     topical garlic concentrate ( GarlicRich) for treatment of children with alopecia areata.~     Study medication will be applied topically on affected area of the skin daily for 6 months.~     Follow up visits will occur monthly to access the efficacy and safety of the proposed~     treatment .~   "
27965|NCT02691104|"~     The investigators are carrying out a feasibility study to explore whether an app for~     physical activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people~     with the condition and to healthcare professionals who help patients manage the condition.~   "
27966|NCT02691078|"~     Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA~     (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the~     111In - DTPA-octreotide.~   "
27967|NCT02691065|"~     Human immunodeficiency virus (HIV) infection damages body defence mainly by affecting two~     important white blood cells called cluster of differentiation (CD4) T cells and monocytes.~     This immune dysfunction leads to persistent inflammation, which is partially resolved with~     long-term anti-HIV therapy. Importantly, such inflammation increases risk for~     cardiovascular, diabetes, and kidney diseases. The causes of this inflammation are largely~     unknown and include HIV itself, presence of other infections, lifestyle characteristics like~     increased cholesterol levels, obesity, smoking and alcohol abuse. In addition, inflammation~     can be driven by certain type of anti-HIV therapy called protease inhibitor (PI). PI has~     been associated with an increase of cholesterol and may contribute to inflammation. A new~     class of medication that is now available in Canada called integrase inhibitor (II) may have~     a lesser or no effect on cholesterol levels. Therefore, it is important to study the effect~     of II on cholesterol levels and inflammation.~      The purpose of this study is to assess the inflammatory changes, in the blood of persons~     treated with PI that will switch to the II or may remain on their PI-containing regimen. By~     comparing persons continuing their current PI-based regimen with those who switch to~     II-based regimen, we will know if the change from PI to raltegravir (Isentress), a type of~     II, decreases lipids and inflammatory markers.~      The adult persons living with HIV, who are on PI-based therapy for more than a year, with~     any CD4 T cell count and plasma viral load below level of detection, will be invited to~     participate in the study. 40 study participants will be selected by randomization (like a~     toss of a coin) to either continue PI-based regimen (20 participants) or switch to~     raltegravir-based regimen (20 participants) for a period of 12 months. Blood samples of the~     study participants will be drawn before, during and at the end of study to evaluate changes~     in markers of inflammation, cholesterol level and CD4 T cell and monocyte function. No~     experimental anti-HIV medication will be used; change of therapy will include raltegravir~     which is one of currently recommended medications to treat HIV in Canada.~      This study will be able to answer this important question whether inflammation can be~     decreased by switching therapy from PI-based therapy to raltegravir-based therapy.~     Ultimately, information provided by this study will contribute to the health of persons~     living with HIV.~   "
27978|NCT02690922|"~     The aim of our study is to improve the major molecular remission(MMR) rate and reduce the~     cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens~     and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy~     drugs, lower the side effect brought by which this would be a grateful news for the patients~     once this regimens gain a successful result, which is also the final aim of our efforts.~   "
27968|NCT02691052|"~     Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine~     vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL)~     under this combination therapy. In the framework of a German multicenter prospective,~     observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under~     treatment will be analyzed and data will be compared to existing data of the gemcitabine~     mono therapy.~      QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over~     a 6-month period. Additionally patients are requested to answer a supplementary~     questionnaire addressing e.g. fears related to QoL deterioration and side effects of~     chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health~     Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90~     study sites in Germany.~   "
27969|NCT02691039|"~     The purpose of this project is to create a database to collect information about the NEW~     Keiki Program. The information collected for this project will be used to evaluate the~     program. The NEW Keiki program promotes healthy lifestyles and behavior changes.~   "
27970|NCT02691026|"~     This is phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in~     subjects with metastatic or locally advanced/unresectable or metastatic malignant peripheral~     nerve sheath tumour (MPNST).~      The patients will be treated with pembrolizumab for up to 10 cycles.~      Primary objective is to evaluate the percentage of patients with curatively unresectable~     MPNST who have achieved clinical response; complete response (CR), partial response (PR), or~     stable disease (SD) at 18 weeks as assessed by the Investigator, by using RECIST, v1.1.~   "
27971|NCT02691013|"~     Sleep deprivation is known to affect brain function but is often ignored in the sickest~     patients including those in the intensive care unit after major surgery. In these patients,~     the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain~     that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test~     whether improving sleep quality affects the risk of developing confusion (delirium) in~     patients having clot removed from their lung (open heart surgery). In order to improve sleep~     quality, the investigators will conduct a study of Ramelteon, a medication that mimics the~     activity of melatonin and measure its effects on levels of melatonin and monitor sleep.~   "
27972|NCT02691000|"~     The Light-Heart study is a randomized, double-blind, controlled trial investigating the~     effects of bright white light (BWL) therapy on depressive symptoms, quality of life, and~     functioning in patients with Stage B heart failure. The study is a randomized, double-blind,~     controlled trial of 8 weeks of morning BWL therapy compared with morning dim red light (DRL)~     treatment in older (60 years or older) 122 Stage B (early, asymptomatic) HF patients.~   "
27973|NCT02690987|"~     The Gut Hormone in Addiction study is a proof-of-concept experimental medicine human study~     to answer the following questions:~        1. Does the administration of the hormone desacyl ghrelin reduce core behavioural~          components of addiction in dependent individuals who have recently stopped smoking~          tobacco or drinking alcohol, or overweight/obese subjects?~        2. Does the administration of the drug Exenatide reduce core behavioural components of~          addiction in dependent individuals who have recently stopped smoking tobacco or~          drinking alcohol, or overweight/obese subjects?~        3. Does the administration of desacyl ghrelin or Exenatide reduce reward responses to~          high-calorie foods and appetite in dependent individuals who have recently stopped~          smoking tobacco or drinking alcohol, or overweight/obese subjects?~   "
27974|NCT02690974|"~     The primary purpose of the study will be to describe the tolerability of treatment with the~     optimal dose of LCZ696 (97.2 mg sacubitril / 102.8 mg valsartan bid), over six (6) months,~     in patients with heart failure with reduced ejection fraction (HFrEF) in Canada.~      The study will also describe the overall tolerability, effectiveness and safety of LCZ696~     for the management of HFrEF over 12 months of treatment, as well as describe the patterns of~     LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.~   "
27975|NCT02690961|"~     The purpose of this study is to assess safety, tolerance and pharmacokinetics of~     Multiple-dose Kukoamine B Mesilate in healthy volunteers~   "
27976|NCT02690948|"~     This phase II trial studies how well pembrolizumab with or without vismodegib works in~     treating patients with skin basal cell cancer that has spread to other places in the body or~     cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, blocks tumor~     growth in different ways by targeting certain cells. Vismodegib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     pembrolizumab is more effective alone or together with vismodegib in treating skin basal~     cell cancer.~   "
27977|NCT02690935|"~     The primary objective of this study is to demonstrate the superiority of 2L®ALERG over~     placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic~     rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according~     to rescue medication intake. The secondary objectives are to compare the allergy symptoms,~     the rescue medication intake, the quality of life and the safety in patients treated with~     2L®ALERG or with a placebo.~      This is a multicentre, randomized, double-blind, two-parallel group, interventional~     placebo-controlled study with a notified homeopathic medication, marketed since 2002.~      Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a~     total of 100 patients included for 80 cases completed.~      Screening will be done before the peak of pollination and the treatment will be set up two~     months before traditional pollen peak, then visits at 3 months and 6 months, or end of the~     peak.~      The treatment will consist of 1 capsule daily, fasting morning, following the numerical~     order of 1 to 10 capsules for 6 months.~      The placebo will have the same form, colour, taste and aspect. The allowed concomitant~     treatments are the already established treatments for associated pathologies not liable to~     have an impact on the proper conduct of the study and the rescue medications allowed in the~     first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye~     cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those~     above]).~      The prohibited treatments are the oral or injectable corticosteroids and the~     anti-leukotrienes.~   "
28039|NCT02690116|"~     The purpose of this study is to test whether Meditative Movement (based on a standardized~     and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other~     symptoms in women after treatment for breast cancer than (a) a non-meditative sham Qigong~     active intervention and (b) an inactive education / support group.~   "
27979|NCT02690909|"~     The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of~     ablation features and technical improvements over previously designed systems into a single~     product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation~     of the sympathetic nerve network surrounding the renal arteries.~      This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal~     Denervation device and to demonstrate that it performs according to its intended use, i.e.~     the treatment of patients with uncontrolled hypertension.~   "
27980|NCT02690896|"~     The purpose of this study is to examine the effectiveness of support group intervention for~     primary caregivers of a person with dementia or similar cognitive impairment.~   "
27981|NCT02690883|"~     This is a multi-center, randomized, parallel study to evaluate effect of exenatide on~     24h-UAER in patients with diabetic nephropathy.~      Screening will be made to select eligible participants before intervention. The trial will~     include 2-week run-in period of stable doses of glargine plus lispro insulin and 24-week~     treatment period. After the run-in period, patients were randomly assigned to one of two~     groups for antihyperglycaemic therapies for a total of 24-weeks: glargine plus exenatide and~     continued glargine plus lispro insulin. The treatment of exenatide will be initiated by 5ug~     bid, and uptitrated to 10 ug bid after 4 weeks and then maintained at 10ug bid until the~     completion of the study. Lispro insulin will be initially treated according to the insulin~     dosage of previous antihyperglycaemic therapies, and further titrated up at 4-week intervals~     until to reach the target fasting blood glucose (FPG).~   "
27982|NCT02690870|"~     The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and~     clomiphene citrate in mild stimulation.~   "
27983|NCT02690857|"~     Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant~     systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable~     role in reducing redox status.~      In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower~     oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for~     the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured.~     Plasma and platelet lipid compositions will be determined.~   "
27984|NCT02690844|"~     What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with~     clonazepam have in the treatment of burning mouth syndrome?~      There are no clinical trials reported in the literature that evaluate the use of a~     mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth~     syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a~     greater reduction in symptoms.~   "
27985|NCT02690831|"~     The aim of this study is to assess if an intervention of manual therapy and motor control~     exercises combined with an inspiratory muscle training program is more effective than an~     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in~     patients with asthma. In addition, the study pretends to evaluate the changes caused by the~     intervention regarding possible postural changes and thoracic diameter.~   "
27986|NCT02690818|"~     The purpose of this pilot study is to determine whether regularly scheduled medication~     reminder text messages (SMS) are effective in increasing latent tuberculosis infection~     (LTBI) treatment completion.~   "
27987|NCT02690805|"~     The purpose of this research study is to investigate the accuracy of a breast imaging system~     that measures the uptake of the injected radioactive tracer by gamma-ray imaging, known as~     scinti-mammography (SMM), to diagnose the residual breast cancer after neoadjuvant~     chemotherapy (NAC) treatment by comparing to MRI.~   "
27988|NCT02690792|"~     One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity~     and ~8 million of these individuals have a progressive form of the disease, non-alcoholic~     steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which~     individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a~     prelude to the development of end-stage liver disease.~      The study of NAFLD has been limited by several factors, including the difficulties~     associated with studying liver metabolism in vivo in humans. Our group has pioneered new~     methods that use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism~     in humans with a goal of directly studying the pathophysiology of bland steatosis and NASH.~     In this study, these noninvasive methods will be used to characterize and compare the~     metabolic alterations that accompany bland steatosis and NASH and test the hypothesis that~     detects if hepatic mitochondrial metabolism contribute to both disorders. Such~     characterization is fundamental to establishing a rational approach to the prevention and~     treatment of NAFLD and may provide simple, non-invasive methods to differentiate benign and~     progressive forms of NAFLD.~      This proposal will be addressed via separate isotopic studies occurring at different time~     points during a prolonged fast. In subjects with NAFLD, these studies will be carried out~     before and after treatment with Vitamin E or placebo.~      Healthy subjects will participate in initial baseline studies only without Vitamin E or~     placebo intervention.~      The study is designed to harness the physiologic changes that occur with short- and~     long-term fasting to provide a rapid and cost-effective method to accomplish the aims of the~     application.~   "
27989|NCT02690779|"~     The study will consist of a prospective observational period performed in the GI Endoscopy~     Lab. The objective is to document the quality of bowel preps in patients undergoing a~     screening colonoscopy with and without an educational intervention.~   "
27990|NCT02690766|"~     Investigators proposed to refine and test the feasibility and acceptability of a 4-month~     multi-modal lifestyle intervention in African American female breast or endometrial cancer~     survivors diagnosed with type 2 diabetes.~   "
28030|NCT02690233|"~     This study on minor surgery serves to explore whether a dose-response relationship exists~     between surgical stress and endothelial dysfunction in the early postoperative period. The~     aim of this explorative and observational clinical study is to closely examine the~     endothelial function and its dynamics in the early postoperative period after minor surgery~     (lap. inguinal hernia repair). The endothelial function will be assessed indirectly by~     EndoPat and plasma biomarkers of nitric oxide bioavailability. The study will contribute to~     the understanding of perioperative myocardial injury, which is crucial for optimized~     treatment of patients at risk of cardiovascular complications.~   "
28031|NCT02690220|"~     The purpose of this study is to determine the influence of anterior pelvic prolapse~     reconstruction with a titanized polypropylene mesh on patients quality of life.~   "
27991|NCT02690753|"~     The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors~     are pressure or pressure combined with shear. Prevention is very important and comprises:~     preventive skin care including cleansing and protecting the skin from exposure to moisture,~     the systematic repositioning of the patient, the offloading of the heels from the surface of~     the bed, the use of adequate bed support surfaces and an adequate nutritional status. The~     development and implementation of a risk based prevention plan for individuals identified as~     being at risk is strongly recommended. Limited compliance exists towards pressure ulcer~     preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in~     bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of~     rigorously performed research addressing the effectiveness of devices or risk based~     protocols to improve compliance. Health care budgets are limited, priorities should be set~     in the allocation of health care resources.~      The primary aim of this study is to compare the effectiveness of the turn and position~     system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve~     reposition frequence in patients at risk. The second aim is to compare the effectiveness of~     a tailored protocol versus standard care to improve reposition frequence in patients at~     risk. The third aim is to compare the effectiveness of standardized incontinence care versus~     standard care to improve the incidence of pressure ulcers and incontinence-associated~     dermatitis (IAD). Also a health economic evaluation will be performed.~      The study will be performed in hospital setting (university and general hospitals) in a~     random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers.~     Patients will be recruited from three types of wards: intensive care units, geriatric wards~     and rehabilitation wards. Patients will be included in the study for a period of 8 days.~   "
27992|NCT02690740|"~     The clinical relevance of an allergen-specific sensitization is proven e.g., by allergen~     challenge tests in clinical routine. Several protocols for different challenge tests such as~     nasal (NPT), bronchial (BPT) or conjunctival provocation test (CPT) have been proposed.~     Beneath others, the CPT is broadly used in both clinical trials and routine because of its~     feasibility.~      However, there is no internationally harmonized standard regarding the clinical~     interpretation of CPT results as well as a lack of validation of a specific outcome score.~     Therefore, this trial aims to investigate and validate a new scoring system for CPT results~     in order to provide this test as a useful method in future clinical trials.~   "
27993|NCT02690727|"~     This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,~     single dose crossover food effect study in 18 subjects. The subjects will receive the study~     medication under either fed or fast during each treatment period.~   "
27994|NCT02690714|"~     This is a Phase 2/3 pivotal study of ProMetic Plasminogen (Human) Intravenous Lyophilized~     solution.~      The primary objective of the study is to achieve a consistent increase of individual trough~     plasminogen activity levels.~   "
27995|NCT02690701|"~     This study will evaluate the effect of secukinumab compared to placebo on aortic vascular~     inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly~     controlled by current psoriasis treatments.~   "
27996|NCT02690688|"~     Dynamic preload variables like pulse-pressure and stroke volume variation may be used to~     predict fluid responsiveness in patients during controlled ventilation. Previous work has~     shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic~     preload parameters, suggestive of a fluid deficit - despite fluid status had not changed~     [van Lavieren M 2014].~      The results of this study are limited by the fact that a non-invasive and uncalibrated~     hemodynamic monitoring system (Nexfin™) was used.~      The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic~     preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring~     (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive~     surgical procedures with pneumoperitoneum.~   "
27997|NCT02690675|"~     Objective: To evaluate the effect of Iron supplement with two different amounts (one in the~     higher limit and another in the lower limit of the suggested amount) according to the~     presence of mutations in the HFE gene in the physical, immune and neurobehavioral~     development in the 6 to 12 moth toddlers.~      Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital.~     Methods: At 6 and 12 months it done clinical history, food registry, biochemist~     determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune~     response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D,~     S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of~     Infant Development 2on Edition: 1993). We evaluate the level of language and communication~     (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and~     environment surroundings (Scale Health General Parental Stress Index).~   "
27998|NCT02690662|"~     The objective of this study is to evaluate the influence of low-calorie diet on serum and~     urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic~     abnormalities.~   "
27999|NCT02690649|"~     This is an interventional study designed to develop patient focused strategies that improve~     adherence to anticoagulant medication in patients with non-valvular atrial fibrillation~     (AF). Outcomes of this work include a novel intervention, as well as information regarding~     patient preferences for tailored education.~   "
28000|NCT02690636|"~     Breast cancer patients operated with modified radical mastectomy or breast conservative~     surgery will be randomized for either adjuvant conventional radiotherapy versus~     hypofractionated radiotherapy for chest wall and axilla or breast and axilla.~      The patients will be recruited for one year and will be followed for 5 years by monitoring~     local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.~   "
28012|NCT02690480|"~     This is an international, multicentre, double-blind, controlled, randomized phase II study~     comparing the efficacy and safety of fulvestrant in combination with palbociclib versus~     fulvestrant plus placebo in postmenopausal women with HR-positive/HER2-negative metastatic~     breast cancer who have received ≥5 years of endocrine therapy in the adjuvant setting as~     treatment for early disease and remained disease free for > 12 months following its~     completion or have de novo metastatic disease. Patients must have at least one lesion~     (measurable and/or non-measurable) that can be accurately assessed at baseline and is~     suitable for repeated assessment by CT, MRI or plan x-ray. Patients with bone-only disease~     must have a lytic or mixed (lytic + blastic) lesion, which has not been previously~     irradiated and can be accurately assessed by CT/MRI or x-ray. Approximately 190 patients~     will be randomized 1:1 between the experimental arm (approximately 95 patients treated with~     fulvestrant plus palbociclib) and the control arm (approximately 95 patients treated with~     fulvestrant plus placebo).~      Primary Objective:~      • To compare the efficacy of fulvestrant in combination with palbociclib versus fulvestrant~     plus placebo in terms of the rate of Progression-Free Survival (PFS) at 1 year in~     postmenopausal women with HR-positive/HER2-negative metastatic breast cancer previously~     treated with endocrine therapy for at least 5 years and remaining disease free for more than~     12 months following its completion or have de novo metastatic disease~   "
28001|NCT02690623|"~     Background. Hospitalists predominantly engaged in inpatient care constitute a fundamental,~     poorly assessed change in medical care. The University of Texas Houston Pediatrics~     Department is developing a Hospitalist Division to staff Children's Memorial Hermann~     Hospital. Demonstration of its benefits and cost-effectiveness is important to secure~     adequate, sustained hospital or 3rd-party reimbursement.~      Design. Prospective step wedged quality improvement (QI) study with pediatric hospitalists~     sequentially assuming 24/7 responsibility for each of the 4 pediatric inpatient services~     over 2-3 years. This design allows within- and between-group analyses and is particularly~     desirable for evaluating interventions likely to be beneficial that will be given stepwise~     to an increasing % of patients.~      Intervention. Faculty of the new Pediatric Hospitalist Division will initially become~     responsible 24/7 for 1-2 of the 4 services now staffed by the General Pediatric Division.~     Currently, each pediatric service admits every other patient without regard to diagnosis,~     resulting in quasi-random patient assignment.~      Outcomes: Total hospital days (including 30-day readmissions); intubation; pediatric~     intensive care unit (ICU) admissions; parent, nurse, and resident satisfaction; and costs~     assessed using state-of-the-art methods and expressed from the health system, medical~     school, and hospital perspectives.~      Hypotheses. Hospitalists will improve clinical outcomes and parent, nurse, and resident~     satisfaction and be cost-effective (primary outcome), assessed by net cost or savings per~     hospital day prevented (health system perspective).~      Analyses. Frequentist and Bayesian analyses to assess the probability of benefit and of~     cost-effectiveness.~   "
28002|NCT02690610|"~     This prospective study will include 30 patients with hilar/mediastinal lymph nodes detected~     by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for~     diagnosing purpose).~      All patients will undergo to ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive~     procedures will be performed if EBUS-guided TBNA doesn't provide representative material.~   "
28003|NCT02690597|"~     Screening of anxiogenic part of pain is an imperative during a medical pain consultation.~     The actual tools for evaluation of this specific part are complex and time consuming.~      To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient~     in pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety~     analogic visual scale by comparison with the actual reference the self-assessment~     questionnaire State Trait Inventory Anxiety Y-A form.~   "
28004|NCT02690584|"~     The purpose of this open trial is to investigate the feasibility, acceptability, and effect~     of metacognitive therapy in patients with prolonged post-concussive symptoms after mild~     traumatic brain injury.~   "
28005|NCT02690571|"~     Air pollution is a global environmental and health concern, contributing to onset and~     deterioration of respiratory and cardiovascular diseases. As climate change and dependence~     on diminishing fossil fuel supplies have taken center stage in political and scientific~     debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The~     most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is~     perceived to be a green fuel, as it is sustainable and of biological origin, and therefore~     is often predicted to be less harmful to human health. Whilst replacing petrodiesel with~     biodiesel may have advantageous ecological impacts, consequences to respiratory health~     remained largely unexplored.~      The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel~     exhaust would result in an acute airway inflammatory response in healthy human subjects, as~     shown previously following exposure to petrodiesel exhaust.~   "
28006|NCT02690558|"~     The purpose of this study is to look at whether adding pembrolizumab (keytruda) to the~     combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a~     cystectomy, for people with muscle-invasive bladder cancer (MIBC).~   "
28007|NCT02690545|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by~     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which~     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are~     special infection-fighting blood cells that can kill other cells, including tumor cells or~     cells that are infected. Both antibodies and T cells have been used to treat patients with~     cancers. They both have shown promise, but neither alone has been sufficient to cure most~     patients. This study is designed to combine both T cells and antibodies to create a more~     effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted~     against the CD30 antigen (ATLCAR.CD30) administration.~      In previous studies, it has been shown that a new gene can be put into T cells that will~     increase their ability to recognize and kill cancer cells. The new gene that is put in the T~     cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma~     cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies~     have been used to treat people with lymphoma, but have not been strong enough to cure most~     patients. For this study, the anti-CD30 antibody has been changed so that instead of~     floating free in the blood it is now joined to the T cells. When an antibody is joined to a~     T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination)~     receptor-activated T cells seem to kill some of the tumor, but they do not last very long in~     the body and so their chances of fighting the cancer are unknown.~      The purpose of this research study is to establish a safe dose of ATLCAR.CD30 cells to~     infuse after lymphodepleting chemotherapy and to estimate the number patients whose cancer~     does not progress for two years after ATLCAR.CD30 administration. This study will also look~     at other effects of ATLCAR.CD30 cells, including their effect on the patient's cancer.~   "
28008|NCT02690532|"~     This study will assess the effect of gluten on gut barrier function. Investigators at the~     Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water~     solution), and are hoping to prove its effectiveness in a clinical setting.~   "
28009|NCT02690519|"~     At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks,~     consisting of two consecutive treatment periods of two weeks evaluating one dose of GLPG1837~     each. After the treatment period, there is a 7-10 days follow-up period.~      During the course of the study, subjects will be examined for any side effects that may~     occur (safety and tolerability).~      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes~     in pulmonary function (efficacy) will be explored throughout the study. The amount of~     GLPG1837 present in the blood (pharmacokinetics) will also be determined.~   "
28010|NCT02690506|"~     Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it~     was reported that premedication of pregabalin before general anesthesia is effective to~     reduce postoperative pain. Up to date, there is no study about the effect of premedication~     of pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate~     the effect of premedication of pregabalin on the spinal anesthesia.~   "
28011|NCT02690493|"~     The purpose of this study is to determine whether acupuncture and taping are effective in~     the treatment of spastic upper limb after stroke.~   "
42053|NCT02506751|"~     This study will evaluate the safety and tolerability of synthetic T3, liothyronine. It will~     establish if there are changes in MS symptoms and if there is a positive effect on markers~     of neuronal health.~   "
28014|NCT02690454|"~     Ticagrelor is a direct-acting, reversible platelet P2Y12 receptor inhibitor recommended by~     the recent European Society of Cardiology guidelines in patients with acute coronary~     syndromes (ACS) (class of recommendation I, level of evidence B). Ticagrelor inhibits~     platelet function stronger, faster and more consistently than clopidogrel, the former~     standard of antiplatelet therapy. In the landmark PLATO trial (Study of PLATelet inhibition~     and patient Outcomes), ticagrelor therapy as compared with clopidogrel treatment was~     associated with the reduced occurrence of major adverse cardiovascular events and all-cause~     mortality, but also resulted in a small, but statistically significant, increase in the rate~     of major bleeding. The optimum choice of antiplatelet treatment, aimed to provide each~     patient with maximum protection against ischemic events, while minimizing the risk of~     bleeding complications, is the challenge of contemporary ACS therapy. The tool which may~     help physicians and facilitate clinical decision making is platelet function testing.~     According to the guidance of both European and American groups of experts, there are three~     currently recommended platelet function tests, namely the VerifyNow device, the Multiplate~     analyzer and the Vasodilator Stimulated Phosphoprotein Phosphorylation (VASP) assay. It~     needs to be emphasized that none of these three methods is preferred over others. So far~     there are no studies linking pharmacokinetic analysis of ticagrelor and its active~     metabolite with comparative evaluation of platelet reactivity. The aim of this trial is to~     assess the relationship between concentrations of ticagrelor and its active metabolite~     (AR-C124910XX) and results of all three recommended platelet function tests in patients with~     myocardial infarction. Patients who receive GP IIb/IIIa receptor inhibitor will be excluded~     from the primary analysis.~      Statistical analysis: The correlation will be assessed using correlation coefficients and~     intraclass correlation coefficients. while the agreement between the results of the compared~     platelet function tests will be measured using the Kappa statistic and Bland-Altman~     analysis.~   "
28015|NCT02690441|"~     Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is~     highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for~     the development of other severe conditions such as depression and dementia, and effective~     treatments are called for. However, recommended treatment for GAD has consistently been~     found to yield blunted response rates for older adults compared to younger patients.~      The purpose of this study is to evaluate the effects of exercise-augmented cognitive~     behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield~     better results than standard CBT in terms of greater reduction of symptoms and increased~     rates of remission. The investigators will also investigate the effects of treatment on~     biological, physiological and neuropsychological measures.~   "
28016|NCT02690428|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has~     previously been characterized in breast cancer patients after receiving imILT treatment ,~     and presumed abscopal effects induced by imILT have also been described in a malignant~     melanoma patient.~      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction~     of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also~     to investigate the functionality and safety as well as understanding of the subsequent~     immunological effects. Since immunologically based treatment of various solid tumors is~     under intense review with so called immune checkpoint inhibitors this trial will also~     provide valuable information on how imILT, in the future, could be combined with these new~     and, for some patients, very effective treatment regimens.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic~     T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor~     border. Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed~     with solid tumors will be treated in this trial, which is estimated to be carried out during~     a time period of 18 months.~   "
28017|NCT02690415|"~     Infections due to S. aureus are a major healthcare burden. Currently there is not an~     effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of~     patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are~     often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines~     suggest that incision and drainage alone may be adequate for management of uncomplicated~     CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is~     not known whether antibiotics are helpful in decreasing S. aureus colonization rates or~     preventing future S. aureus infections. Though resolution of acute abscess after drainage~     may be unchanged by antibiotic administration, the impact of managing S. aureus abscess~     without antibiotics on ongoing S. aureus colonization and recurrent infection requires~     further study. This study seeks to examine whether the management of initial S. aureus~     abscesses with incision and drainage in addition to antibiotic therapy is an effective means~     of preventing recurrent infection. The prolonged longitudinal follow-up of this study is~     another unique characteristic that will enable the investigators to capture data about~     recurrences of infections.~   "
28018|NCT02690402|"~     Older people are a very heterogeneous population characterized by a high interindividual~     variability. Functional abilities (walking, transfers ...) used to classify individuals aged~     (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS,~     2005). Frailty is generally considered as a state that precedes dependent status and, unlike~     the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and~     quantify the indicators above the dependence of the elderly from a multidisciplinary~     approach to frailty, is a critical public health issue for developing non-drug therapeutic~     interventions adapted to delay the institutionalization. Through this study, it is to~     identify risk and protective factors of frailty and their relationships with physical~     activity, evaluate them and propose an appropriate care to the patient. This study should~     enable the production of new scientific knowledge to improve the health and quality of life~     of older people.~   "
28019|NCT02690389|"~     Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in~     general anaesthesia through investigating the role of the Benzodiazepines-GABA system.~      Method: 80 patients undergoing abdominal surgery were randomly divided into four groups~     (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group~     (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture +~     flumazenil group). Before induction, acupuncture needles were inserted at the points of~     Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicitDeQi. Target-controlled infusion~     (TCI) of propofol was used for the induction and maintenance of anaesthesia. After~     15minutes, equilibrium of Narcotrend Index (NT index) was achieved, patients were then~     assigned to receive different interventions. In EA group and EA+F group, patients received~     EA for 30 minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was~     added in the latter at the end of EA. In C group and F group, patients didn't receive EA,~     and flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time~     point with EA+F group. HR, MAP and NT index were recorded at different time points up to 30~     minutes after the end of EA.~   "
28082|NCT02689557|"~     Successfully develop and confirm with the Higher School of Electronics West Plethysmographic~     a multichannel recorder to perform measurements staggered volume of the lower limbs at rest,~     walking and recovery (6 storied measures on members lower).~   "
28020|NCT02690376|"~     Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI~     disorders. But it is uncomfortable for patients and incurs the risk of intubation and~     sedation, plus a large proportion of procedures reveal insignificant or no pathology.~     Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is~     safe, non-invasive and well-tolerated. The use of CE is traditionally restricted to the~     small bowel, although newer capsules to image the oesophagus and colon are currently in use.~     Previous capsules have failed to adequately image the stomach due to its' large volume and~     rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam~     Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule.~     This is unnecessary in the small bowel where the capsule is propelled along its' tubular~     structure by peristalsis, but in the capacious stomach this may allow the capsule to be~     steered to examine all areas of the stomach. We have already conducted two feasibility~     studies in porcine models with promising results and a trial has already evaluated the~     equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing~     study is comparing the ability of this technique to examine the stomach against conventional~     OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare~     the two modalities under other different conditions.~      We wish to undertake a prospective single blind controlled trial comparing magnetically~     assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal~     pathology in patients with gastrointestinal bleeding.~   "
28021|NCT02690350|"~     U3-1784 is a human monoclonal antibody specifically raised against the Fibroblast Growth~     Factor Receptor 4 (FGFR4). The purpose of this study is to assess safety and tolerability of~     U3-1784, an FGFR4 human monoclonal antibody, in advanced tumour and HCC patients. The study~     is designed to identify a safe and tolerated dose in advanced tumour patients using a 3+3~     dosing. The selected dose will then be used to assess safety and tolerability in HCC~     patients.~   "
28022|NCT02690337|"~     This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of~     DS-1123a in Japanese subjects with advanced solid tumors.~   "
28023|NCT02690324|"~     development of skin adhesive patches for the monitoring and prediction of mental disorders~   "
28024|NCT02690311|"~     Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue~     Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled~     Comparison~   "
28025|NCT02690298|"~     Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate~     measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after~     calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR~     values measured by the ExSpiron™ without prior spirometer calibration to values obtained~     with a spirometer calibration. In this study, the MV and TV values will be compared between~     the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a~     spirometer~   "
28026|NCT02690285|"~     The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a~     healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA)~     metabolism based on haplotype analysis.~      The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency~     (PDCD).~      This pilot study, focuses on developing a high throughput, sensitive and accurate screening~     test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals~     who would be treated with DCA.~   "
28027|NCT02690272|"~     The kidney transplant remains the privileged treatment of the terminal renal insufficiency.~     This care is complex for the patient both on a medical surgical plan and by the psychic~     reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes~     psychological reasons. The research work consists in highlighting the psychic mechanisms of~     the subjects awaiting kidney transplant.~   "
28028|NCT02690259|"~     In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high~     risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas~     no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative~     risk group allocation is known to be erroneous in up to 15% of patients.~      A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential~     to spare extensive surgery in 80% of high risk patients, identify low risk patients with~     nodal metastases, diminish side effects caused by full lymphadenectomy and render some~     expensive preoperative risk group allocation measures unnecessary.~      A clinically useful SLN technique requires a high technical success rate, a clear definition~     of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer~     and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic~     anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of~     colored/ signaling nodes. Therefore, a definition of a SLN requires identification of~     efferent/afferent lymph vessels.~      Several publications describe sentinel node techniques in EC with a variety of tracers~     (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described~     as radioactive nodes or colored nodes only with no further discrimination. No study~     relate to an anatomical description of lymphatic pathways.~      The aims of this study is to systematically display the major anatomical pathways with the~     use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on~     lymphatic anatomy and identification of efferent lymph vessels.~   "
28029|NCT02690246|"~     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is~     an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia~     and visceral arteriovenous malformations. The purpose of this study is to provide data about~     multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects~     also data of non-affected relatives is collected (second cohort). the questionnaire has been~     designed primarily for web based entry, but can also be circulated in paper format on~     request.~   "
28032|NCT02690207|"~     The purpose of this study is to cross-vaccinate and collect safety data in terms of~     unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune~     Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received~     placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).~   "
31994|NCT02638324|"~     The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart~     failure patients. The present study is planned to reduce the sympathetic tone in patients~     with severe heart failure by renal nervous denervation.~   "
28040|NCT02690103|"~     Current treatments for Hepatitis C virus (HCV) have severe side effects and are very~     expensive. There is a need to explore effective natural therapies against HCV that are less~     toxic and more cost-effective.~      37 chronic HCV infected patients were randomized into two groups and treated with PEG~     interferon plus ribavirin for the first group or Biobran, an arabinoxylan from rice bran (1~     g/day) for the second group. Viremia level, liver enzymes, γ-interferon (IFN-γ) levels in~     serum, and toxicity were checked before and three months after treatment.~   "
28041|NCT02690090|"~     The investigators study is the first step (a pilot study) in determining whether the~     manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are~     patients in an intensive care unit and have severely reduced kidney function (less than or~     equal to approximately 30% of their normal function) is safe with respect to the adverse~     effect of bleeding.~      The investigators hypothesis is that studying these patients, going forward in time, without~     interfering with their care, to eventually determine if this blood thinner is safe at~     reduced doses, is feasible.~   "
28042|NCT02690077|"~     The purpose of this study is to determine if patient birthing experiences differ between the~     family-centered and traditional cesarean methods. We hypothesize that the family-centered~     cesarean method will lead to more unique and personalized cesarean birthing experiences~     without increasing the risks of adverse neonatal and maternal outcomes from those documented~     with the traditional cesarean.~   "
28043|NCT02690064|"~     Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise~     in patients with CF is related to greater death rates, steeper decline in lung function, and~     more frequent lung infections. However, the physiological mechanisms for this reduced~     exercise capacity are unknown. The investigators recently published the first evidence of~     systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect~     that the blood vessels are involved with exercise intolerance in CF. This study will look at~     how and if oxidative stress contributes to both artery dysfunction and exercise intolerance~     in CF.~   "
28044|NCT02690051|"~     A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the~     treatment of Iliac Lesions.~      The objective of this clinical investigation is to evaluate the long-term safety and~     efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification~     when used according to the indications of the IFU.~   "
28045|NCT02690038|"~     This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive~     lung disease (COPD) patients with frequent exacerbations.~      This is a Phase II, pilot randomized double blind control study, meaning this study will~     help assess if this research can be expanded to evaluate Ig treatment in patients with COPD.~     Ig treatment is a sterile solution of human immunoglobulin proteins given intravenously (in~     the vein). Immunoglobulins are part of the immune system and help the body fight infections.~     Participants will be assigned to either receiving the Ig treatment or normal saline as a~     control product every 4 weeks for 12 months.~      Participants will continue on current standard therapy as determined by their treating~     physician.~   "
28046|NCT02690025|"~     A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed~     dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.~   "
28047|NCT02690012|"~     Hypomagnesemia (hMg) is a common side effect of important anti-cancer therapies such as~     epidermal growth factor receptor inhibitors (EGFRIs) and platinum-containing anti-cancer~     drugs. EGFRIs, including cetuximab (cmab) and panitumumab (pmab), have been estimated to~     cause hMg in over 18% and 27% of patients respectively1, while 90% of patients receiving~     cisplatin will develop hMg if left untreated. The development of severe hMg may result in~     increased symptoms such as fatigue, neuromuscular changes, mental status changes and cardiac~     arrhythmias which could result in treatment delays and may compromise treatment efficacy.~     Despite the common occurrence of this toxicity, little is known regarding the optimal~     magnesium management strategy. As physicians do not know what the best treatment for~     patients is, genuine uncertainty (clinical equipoise) exists. Physicians will choose~     between different standards of magnesium replacement in their personal practice, using~     idiosyncratic decision making processes, without the physician or the patient knowing the~     optimal option. This is not good for patients, physicians and society as a whole.~     Determining the optimal treatment remains an important medical issue for patients,~     physicians and society. This study will use a novel method to allow comparisons of~     established standard of care prophylactic treatment using the integrated consent model as~     part of a pragmatic clinical trial7. By integrating medical and clinical practices,~     physicians will be able to inform their patients about the randomized control trial, akin to~     a typical conversation between the physician and patient, without written informed consent.~     This clinical interaction would then be documented, as ordinarily done in practice. Medical~     and clinical practice will be intertwined with the patients' welfare at the forefront of our~     best interests.~   "
28048|NCT02689999|"~     It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and~     then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and~     impedance kinetics.~   "
28049|NCT02689986|"~     Prospective, non-randomized multicenter study on the safety and efficacy of combination~     therapy with bendamustine and rituximab for chronic cold agglutinin disease.~   "
28050|NCT02689973|"~     This longitudinal experimental study tested the effects of three brief interventions: (1)~     prompting the formation of plans (or implementation intentions), (2) prompting self-efficacy~     beliefs, and (3) prompting planning + self-efficacy in adolescents aged 14-18 years relative~     to an active 'education only' control group.~      It was hypothesized that participants assigned to the interventions would exhibit a smaller~     increase in body fat at 14-month follow-up compared to controls. The study also investigated~     whether the combined planning + self-efficacy intervention would have larger effects on the~     main outcome (body fat) than single-component interventions. Second, it was hypothesized~     that the effects of the intervention conditions on body fat at 14-month follow-up would be~     mediated by their respective psychological and behavioral constructs: self-efficacy and~     planning at T2 (Mediator 1), and by moderate-to-vigorous physical activity (MVPA) at T3~     (Mediator 2). It was expected that the effects of the interventions including the planning~     component (i.e., planning intervention and self-efficacy + planning intervention) would be~     mediated by respective cognitions, i.e. planning, whereas the effects of the interventions~     including self-efficacy component (i.e., self-efficacy intervention and self-efficacy +~     planning intervention) would be mediated by self-efficacy. Finally, it was explored whether~     the effects of the intervention (both direct and indirect effects, via their respective~     psychological variables and MVPA) on body fat would be moderated by the presence of built PA~     facilities, located in the proximity of schools.~   "
31995|NCT02638311|"~     Prospective multicenter sample collection and testing study.~   "
28051|NCT02689960|"~     Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement~     dose in conditions of physical or psychological stress to prevent life threatening adrenal~     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.~     gastroenteritis, severe infectious disease), rapid and highly dosed administration of~     glucocorticoids is crucial. The study is conducted to offer female patients the possibility~     to perform efficient prednisone self-administration in emergency situations in a way of~     administration, which is easy to perform and accepted by the patients. Therefore,~     pharmacokinetics and safety of vaginal prednisone administration will be studied and~     compared to rectal administration.~   "
28052|NCT02689947|"~     Prospective single center study to evaluate the safety and effectiveness of Restylane Silk~     for treatment of tear trough correction.~   "
28053|NCT02689934|"~     A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a~     red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium~     longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of~     improvement of the lipid profile and cardiovascular risk.~   "
28054|NCT02689921|"~     This is a prospective, single-arm, phase II study of 32 evaluable patients treated with~     NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy~     for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or~     Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast~     cancer.~   "
28055|NCT02689908|"~     The adjustment of radiation dose in many CT protocol are based on body mass index(BMI) or~     weight of the patient.~      In the literature, neck circumference (NC) has been reported as a new anthropometric~     parameter indicating the body mass for the upper body.~      NC may be an important landmark in the determination of the low dose protocols for upper~     body CT examinations such as neck, chest and coronary CT.~   "
28056|NCT02689895|"~     Highly active antiretroviral therapy (HAART) transformed a once fatal condition into a~     chronic, manageable condition. However, it is estimated that 20-40% of patients on 2nd line~     treatment (2 nucleotide reverse transcriptase inhibitors [NRTIs] and a boosted protease~     inhibitor [PI]) are failing treatment. Figures are thought to be higher in children and~     adolescents.~      The reason why patients are failing 2nd line treatment is not exactly known. Failure has~     been previously attributed to poor adherence. However, some literature shows that some~     patients on boosted PIs achieve and maintain viral suppression despite suboptimal adherence~     (adherence of 80- 95%). Viral factors, like drug resistance, are also implicated in~     treatment failure. However, boosted PIs have high genetic barrier to clinically significant~     mutations. Therefore, a virus would have to harbour multiple PI mutations for the virus to~     have reduced susceptibility to boosted PI regimens. Pharmacological factors such as~     suboptimal dosing, impaired absorption and drug interactions may also be responsible for~     treatment failure.~      If sub-optimal adherence is the reason why children are failing 2nd line treatment, then~     restoring optimal adherence should result in viral suppression, failure of which might mean~     that other causes are contributing to failure. If resistance is the cause of treatment~     failure, then this study will provide evidence for advocating for resistance testing and the~     use of 3rd line antiretroviral drugs. If children with adequate adherence demonstrate~     inadequate drug levels in their plasma, then this study will provide evidence to advocate~     for studies to examine reasons for inadequate drug exposure amongst HIV-infected children.~     These studies are paramount to optimizing dosing algorithms in this population.~      This proposed study will help elucidate reasons for treatment failure in HIV-infected~     children on second line treatment with the aim of ultimately optimizing antiretroviral~     treatment strategies for this important group.~   "
28057|NCT02689882|"~     Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®,~     ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for~     NR have not been reported in humans. This study will use a recently-developed, whole blood~     assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily,~     and will collect history, physical examination and laboratory data to determine the safety~     and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide~     adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether~     this NR dose significantly raises whole blood NAD levels.~   "
28058|NCT02689869|"~     Primary Objectives The primary objective of this study is to evaluate the efficacy of the~     chemotherapy-free combination of ibrutinib and obinutuzumab (GA 101) in patients with~     previously untreated follicular lymphoma (FL) and a high tumor burden. Primary endpoint to~     be observed for this is the rate of progression free survival one year after start of~     therapy.~      Hypothesis The hypothesis of the study is that ibrutinib in combination with obinutuzumab~     will achieve response rates (CR and PR), rates of MRD negativity and PFS which are~     comparable to currently used standard rituximab-chemotherapy combinations such as R-CHOP or~     R-bendamustine in subjects with previously untreated FL and a high tumor burden.~   "
28059|NCT02689856|"~     The objectives of this study are to assess the potential contribution of lidocaine~     hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream~     preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and~     efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I~     or II hemorrhoids. These products reflect common drug combinations of lidocaine~     hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.~   "
28060|NCT02689843|"~     The aim of this study is to evaluate the effects of three-month course of treatment~     modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients~     with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement,~     homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.~   "
28061|NCT02689830|"~     The purpose of this study is to assess the feasibility and safety of Prostate Artery~     Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context~     Benign Prostatic Hypertrophy (BPH).~   "
28083|NCT02689544|"~     The purpose of this study is analyze the effects, acute and chronic, static and dynamic~     stretching on flexibility and neuromuscular and functional performance in active, healthy~     individuals.~      Study hypothesis:~        1. Static stretching program improves flexibility and reduces neuromuscular and functional~          performance in active, healthy individuals.~        2. Static stretching program improves flexibility and neuromuscular and functional~          performance in active, healthy individuals.~   "
28084|NCT02689531|"~     The purpose of this study is to better define the intensive care unit population at highest~     risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia~     (HABP/VABP).~   "
28085|NCT02689518|"~     Clinical and genetic evaluation of individuals treated with intravitreal aflibercept~     injection (Eylea) for neovascular age-related macular degeneration (wet AMD)~   "
32011|NCT02638103|"~     A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous~     administration of TEV-48125 in adult patients with chronic migraine or episodic migraine~   "
28062|NCT02689817|"~     Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of~     hospitalization that have serious consequences on patient morbidity and mortality as well as~     the cost of care. At the core of the problem for patient-centered targeted prevention of~     HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary~     to cause pressure ulcers, and the lack of immediate feedback on whether these interventions~     do anything to substantially offload at risk areas. Previous studies have been inconsistent~     in their findings of an association between duration of time and HAPU occurrence. While~     retrospectively this has been investigated, there is currently no substantial prospective,~     randomized study.~      This study seeks to better understand the interface pressures between the patient and his or~     her support surface and how this relates to the development of pressure ulcers. The effect~     of patient characteristics and the relationship between total length of time on the~     operating table and pressure ulcer development will also be assessed.~      The findings from this study will significantly add to strengthening the body of evidence~     regarding pressure ulcer development, specifically the relationship between the magnitude of~     interface pressure between the patient and the support surface for what duration of time~     leads to the development of a pressure ulcer. The results will provide critical insight into~     the physiologic targets healthcare providers should use to develop better pressure ulcer~     prevention programs, which could ultimately lead to a reduction in the incidence of pressure~     ulcers.~   "
28063|NCT02689804|"~     A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed~     differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate~     emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The~     investigators propose a study to compare serum LNG and UPA levels after administration of a~     single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no~     difference in PK parameters between women with normal BMI and obese women.~   "
28064|NCT02689791|"~     A randomized, single-blind, cross-over study was conducted to determine the effect of~     replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of~     appetite and food intake in healthy adults.~   "
28065|NCT02689778|"~     It is estimated that approximately 30% of patients with diabetes develop diabetic~     nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs~     through various mechanisms such as hyperglycemia, oxidative stress, inflammation and~     fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets~     for this entity. Current treatment options are based on the glycemic control, blood pressure~     control, as well as the use of medications such as angiotensin-converting enzyme inhibitors~     and Angiotensin II receptor antagonists, these actions are not enough to stop progression.~     Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties.~     Although the specific mechanism is unknown, pirfenidone interferes with the expression,~     secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan~     to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients~     with type 2 diabetes and nephropathy. The period of time the treatment will be administered~     will be of 12 months, 62 patients will be included. The primary outcome will be improvement~     in glomerular filtration rate. The secondary outcomes will be number of patients requiring~     replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF -~     β. Change in these parameters will be evaluated at the end of the treatment period (12~     months). Throughout the study the incidence of adverse events will be recorded, wich will~     allow us to learn about the safety and security of the drug in this population.~   "
28066|NCT02689765|"~     Metabolic problems represent one of the major health concerns which are attractive for being~     addressed by nutritional interventions, as these are directly connected to dietary~     habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes~     alleviation properties, but association between anthocyans and prediabetes need to be more~     firmly understood and established from robust clinical data. However, there is little human~     research that has reported on the efficacy of increased anthocyans bioactive consumption on~     insulin sensitivity in pre-diabetes.~   "
28067|NCT02689752|"~     This will be an open-label, single-center study to evaluate pharmacokinetics and safety of~     HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of~     HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will~     investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to~     identify the compound's major metabolites and supply information for clinical application.~   "
28068|NCT02689739|"~     This is a prospective observational study comparing venous Doppler flow in the lower~     extremities of pregnant women. Pregnant women with a BMI >/= 30 will be compared to those~     with a BMI < 30.~   "
28069|NCT02689726|"~     A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of~     GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged~     25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.~   "
28070|NCT02689713|"~     This study seeks to test if the study drug (voriconazole), when applied topically to a burn~     wound on the skin will help to reduce pain.~   "
28071|NCT02689700|"~     The aim of the study is to determine the total concentration of HCMV- and VZV-specific~     IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in~     neonatal bloodstream depending on gestational age at birth.~   "
28072|NCT02689687|"~     This study offers remote monitoring devices for weight and medication adherence, combined~     with behavioral economic approaches, to patients with congestive heart failure (CHF). This~     pilot study aims to evaluate the feasibility of enrollment processes and intervention~     roll-out to inform a randomized controlled trial, to estimate the readmission rate of~     participants, and to assess if and how managing clinicians respond to weight gain alerts~     entered into a participant's electronic medical record.~   "
28103|NCT02689284|"~     This main purpose of this clinical study is to learn about the safety and activity of~     margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and~     gastroesophageal junction cancer.~   "
28104|NCT02689271|"~     To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate~     cancer by better selecting patients who will benefit from diagnostic MRI and by improving~     the performance of the mp-MRI itself~   "
28073|NCT02689674|"~     Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full~     study sample with regard to treatment engagement over weeks 1-12 and alcohol use over weeks~     1-24.~      Hypothesis 1: An intervention that explores several possible treatment options with the~     patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment~     engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).~      Hypothesis 2: An intervention that explores several possible treatment options with the~     patient and provides the chosen option (e.g., MI-PC) will produce better alcohol use~     outcomes than an intervention focused on engagement in IOP only (MI-IOP).~      Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each~     of the three options in MI-PC, retention rates within each option, and alcohol use outcomes~     in each option.~      Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of~     the three options in MI-PC, retention rates within each option, and alcohol use outcomes in~     each option.~      Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC~     varies as a function of engagement group, with regard to treatment engagement over weeks~     1-12 and alcohol use outcomes over weeks 1-24.~      Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be~     significantly larger among patients in the Non-engaged group than among those in the Engaged~     group.~      Hypothesis 2: The predicted main effect on cocaine use outcomes favoring MI-PC over MI-IOP~     will be significantly larger among patients in the Non-engaged group than among those in the~     Engaged group.~   "
28074|NCT02689661|"~     The primary purpose of this study is to discover modifiable risk factors for the development~     of neuropathy, specifically looking at the metabolic syndrome.~   "
28075|NCT02689648|"~     Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is~     largely unknown. The investigators plan to retrospectively analyse a cohort of children who~     were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more~     about symptoms and effects of investigations performed. Furthermore, the investigators plan~     to contact the cases for a follow up using a validated questionnaire and analyse the long~     term prognosis and risk factors for prolonged severe symptoms.~   "
28076|NCT02689635|"~     Patients over 18 years of age, admitted to the hospital with HF exacerbation, will be~     eligible for randomization to low salt or regular diet. Laboratory tests are routinely~     obtained on admission and on the day (or the day before) of discharge (comprehensive~     metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are~     routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability~     Questionnaire will be performed.~      After the discharge, participants will return for follow-up visits as needed for clinical~     indications. Our study coordinator will document changes of symptoms, changes in therapies,~     and capture clinical events like unscheduled hospital visits or visits to the Emergency~     Room. Once during the study patients will be asked about their specific food consumption on~     a prior day, and the Sodium content will be estimated. The final visit will occur in a year~     (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet~     Acceptability Questionnaire quality of life questionnaire will be collected at this point,~     if clinically indicated.~      The majority of study information will be collected from routine care for standard clinical~     indications. The only components added for study purpose are Diet Acceptability~     Questionnaire and collection of the information on consumed foods.~   "
28077|NCT02689622|"~     No prospective study was conducted in elderly patients with cancer to assess the relative~     value of disease-related and patient-related prognosis factors. Patient-related prognostic~     factors have been highlighted in elderly patients with cancer resulting in the necessity of~     a geriatric assessment. The impact on overall survival of all of these factors was~     recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic~     Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric~     assessment domains relevant for the prediction and to recommend simplified tool after~     stratification of geriatric assessment domains thanks to their predictive value.~      The main hypothesis is that patient-related factors will have a better capacity to predict~     survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and~     that the predictive value will be different among assessment tools which allows a selection~     of reduced number of tools for clinical use.~      To best knowledge estimation of predictive value of geriatric assessment tools remains~     unknown and explains why no standardization of practice exists. In testing all tools at the~     same cohort of patients allows to compare different tools and to define minimal and optimal~     geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will~     allow in a second time to measure the impact of the use of this geriatric standardized~     evaluation by comparing patients'care and prognosis according to the use or not by the~     doctors of the new scores.~      Research outcomes are various medical, economic and ethic. Medical because decision-making~     will be improved with simplified geriatric assessment; economic because a better knowledge~     of geriatric assessment will improve treatment toxicity prevention and decrease treatment~     costs. Ethic will be associated with this project because a better knowledge of geriatric~     assessment tools to predict survival and tolerance treatment could improve the choice of~     best supportive care if prognosis markers are not favorable to active therapy. This project~     could induce important modification of practice in this area to an improved personalized~     treatment and simplification of geriatric assessment allowing a large diffusion in hospitals~     and clinics.~   "
28078|NCT02689609|"~     The investigators evaluate if there are radiation dosimetric parameters for the prediction~     of biochemical and clinical hypothyroidism after intensity-modulated radiation therapy~     (IMRT) for non-metastatic nasopharyngeal carcinoma (NPC).~   "
28079|NCT02689596|"~     The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo~     to resting state brain activity in healthy males.~   "
28080|NCT02689583|"~     Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out~     with the goal of improving H. pylori eradication and therapies have changed from~     single-antibiotic treatments to the current multi-antibiotic treatments. However, the~     eradication rate of H. pylori is still less than 80%. The reasons for this low eradication~     rate are likely to be multi-factorial, including the reduced activity of antimicrobial~     drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the~     higher eradication of H. pylori and discover the different mechanism between the current~     infection and refractory infection of H. pylori, it is necessary to perform a prevalence~     survey for eradication of H. pylori based on the results from isolation of H. pylori~     strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene~     sequencing and 16SrRNA sequencing.~   "
28081|NCT02689570|"~     Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines~     contribute to early signs of cardiovascular disease, meaning coronary artery calcifications~     (CAC) and diastolic dysfunction in type 1 diabetes (T1DM).~      Research Design & Methods: A cross-sectional study of T1DM patients without a history of~     cardiovascular disease. CAC and VAT are measured using a CT scan. CAC is scored using the~     Agatston method. Echocardiography is performed to assess contractile abnormalities. Serum~     levels of adipocytokines (adiponectin, leptin, IL-6 and TNF-a) are measured using ELISA~     assays.~   "
28086|NCT02689505|"~     This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating~     study of BI 836880 administered intravenously once a week. The eligible patient population~     will be patients with advanced solid tumors.~      The primary objective of this trial is to determine the maximum tolerated dose (MTD) and~     recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety~     data will be evaluated as secondary objectives.~      Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and~     Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the~     immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced~     solid tumors.~      Dose escalation will be guided by a Bayesian logistic regression model with over dose~     control (EWOC) using at least 2 patients per dose cohorts.~      Safety criteria will be followed, including adverse events according to Common Terminology~     Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination,~     vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).~   "
28087|NCT02689492|"~     The present study will explore the patients satisfaction to COPD medical treatment (i.e.~     pharmacological and not pharmacological treatment) in a clinical real-world setting and how~     the satisfaction for medical treatment is related to clinical parameters, quality of life,~     illness perception and treatment adherence evolution.~      Moreover health care resource consumption will be observed during the observation period.~   "
28088|NCT02689479|"~     In people with type I diabetes, the insulin producing cells in the pancreas have been~     destroyed. Presently one can only evaluate the function of the graft through laboratory~     tests, blood sugars and the insulin requirements. The mass of the insulin producing cells~     and their location are not known. The possibility to study the mass of insulin producing~     cells is of importance when developing new treatment regimes, in order to evaluate their~     efficacy on this parameter.~      The researchers in this study are aiming to develop methods to measure the mass of insulin~     producing cells. A method (positron emission tomography, PET) previously used for the~     diagnosis of tumors of insulin producing cells may also be used to measure the amount of~     insulin producing cells in patients with type I diabetes. They plan to evaluate participants~     with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be~     used to measure the beta cell mass after islet transplantation.~   "
28089|NCT02689466|"~     Background:~      Dystonia is a movement disorder in which a person s muscles contract on their own. This~     causes different parts of the body to twist or turn. The cause of this movement is unknown.~     Researchers think it may have to do with a chemical called acetylcholine. They want to learn~     more about why acetylcholine in the brain doesn t work properly in people with dystonia.~      Objective:~      To better understand how certain parts of the brain take up acetylcholine in people with~     dystonia.~      Eligibility:~      Adults at least 18 years old who have DYT1 dystonia or cervical dystonia.~      Healthy adult volunteers.~      Design:~      Participants will be screened with a medical history, physical exam, and pregnancy test.~      Study visit 1:~      Participants will have a magnetic resonance imaging (MRI) scan of the brain. The MRI scanner~     is a metal cylinder in a strong magnetic field that takes pictures of the brain.~     Participants will lie on a table that slides in and out of the cylinder.~      Study visit 2:~      Participants will have a positron emission tomography (PET) scan. The PET scanner is shaped~     like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A~     small amount of a radioactive chemical that can be detected by the PET scanner will be given~     through an IV line to measure how the brain takes up acetylcholine.~   "
28090|NCT02689453|"~     Background:~      Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination~     of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better~     treatment for ATL.~      Objectives:~      To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL.~     Also, to determine the safe dose of this combination and identify side effects and effects~     on the immune system.~      Eligibility:~      Adults 18 years and older with chronic or acute ATL who have not been helped by other~     treatments.~      Design:~      Participants will be screened with tests that are mostly part of their usual cancer care.~     They will sign a separate consent form for this.~      Weeks 1 and 2: Participants will have a total of 10 visits. They will:~        -  Get rhIL-15 under the skin by needle.~        -  Have a physical exam and vital signs measured.~        -  Give blood samples.~        -  Answer questions about their health and their medicines.~      Week 3: Participants will stay in the clinic. They will:~        -  Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5..~        -  Take medicines to decrease side effects.~        -  Have a computed tomography (CT) scan to evaluate the treatment.~        -  Have a physical exam and vital signs measured.~        -  Give blood samples.~      Answer questions about their health and medicines.~      Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have~     outpatient visits these weeks.~      After treatment, participants will have follow-up visits every few months for up to 2 years.~     At these visits, participants will give blood samples and have CT scans.~   "
28091|NCT02689440|"~     The goal of this clinical research study is to learn if giving half of the recommended FDA~     approved dose of dasatinib can help to control CML as effectively as the full dose of~     dasatinib.~   "
28092|NCT02689427|"~     The goal of this clinical research study is to learn if a combination of enzalutamide and~     paclitaxel can help to control triple-negative breast cancer (TNBC) by shrinking the tumors~     in the breast and/or lymph nodes before they are surgically removed. The safety of this~     treatment combination will also be studied.~   "
28093|NCT02689414|"~     The purpose of this study is to evaluate the effect of preoperative remote ischaemic~     preconditioning (RIPC) on organ damage and the functional characteristics of arteries in~     patients undergoing vascular surgery. In addition, we investigate the connection between~     RIPC and changes in the functional characteristics of arteries and low molecular weight~     metabolites.~   "
28094|NCT02689401|"~     This research study is evaluating a new imaging method using MRI (magnetic resonance~     imaging) to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. This~     MRI study involves an intravenous contrast called Ferumoxytol (FerahemeTM).~   "
28105|NCT02689258|"~     A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or~     HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery~   "
28095|NCT02689388|"~     Post-operative delirium is common after hip fracture surgery and is associated with~     increased length of hospital stay, delayed recovery and increased mortality. Post-operative~     delirium can also decrease patients' quality of life and can increase treatment costs.~     Anaesthesia and pain relief (analgesia) treatments may also influence the incidence of~     delirium, but more research is needed into which techniques are effective in improving~     patient outcomes and decreasing treatment costs. Use of opioids intra-operatively has been~     associated with increased delirium, so using regional analgesia instead may decrease the~     incidence of delirium in patients after surgery compared with systemic analgesia. Both~     regional analgesia (nerve block) and opiod analgesia are common practices for managing~     patients pain. This study compares these to practice to determine the incidence of delirium~     following hip fracture surgery~   "
28096|NCT02689375|"~     25 participants with back pain and no previous spinal surgery will be enrolled from a single~     NHS site in England.~      Participants will have already discussed spinal cord stimulation (SCS) pain management with~     their consultant before being invited to participate. Participants will attend for 10 visits~     over a period of 66 months. At visit one, study suitability screening and informed consent~     will be conducted. Suitable participants will be booked to have SCS trial leads implanted~     and an external programmable High Frequency battery trial box as a day case (Visit 2).~     Participants will be contacted over the next 21 days to assess how the trial is progressing~     and to book a follow up appointment in clinic to remove the trial leads (Visit 3) where a~     treatment decision will be made. If a participant is determined as having had a successful~     trial they will be listed and implanted with a full HF10 SCS implant (Visit 4). The~     participants who proceed to a full HF10 SCS implant will be reviewed in the Clinic at 6, 12,~     24, 36, 48 and 60 months post procedure. Their participation in this study will be no longer~     than 66 months. A successful trial is defined as a reduction in pain by 30% on a Visual~     Analogue Scale. Participants who do not obtain 30% reduction in 21 days is classed as a~     failed trial and once the leads are removed will be reviewed in clinic by the investigator~     for an alternative treatment plan (Visit 4). If a participant is determined a failed trial~     of HF10, they will remain in the study with their consent for the full follow up schedule.~     The follow-up for the failed trial cohort can be conducted via telephone to reduce the~     burden on this trial group.~   "
28097|NCT02689362|"~     This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel~     treatment groups, with active control, will be performed in Brazilian study sites under the~     sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study~     will start after the relevant ethical and regulatory approvals and will have an estimated~     duration of 18 months.~      One hundred and forty-four participants with T2DM according to the criteria of ADA who~     consent to participation in the study by signing the Informed Consent Form (ICF) will be~     enrolled in the study. In order to be enrolled, the patients must meet all the inclusion~     criteria and none of the exclusion criteria. The eligible participants will be randomized~     1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36)~     or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single~     daily dose, for 12 weeks.~   "
28098|NCT02689349|"~     The New Enrollment Post-Approval Study is designed to evaluate the long-term safety and~     efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from~     moderate to severe hearing loss.~   "
28099|NCT02689336|"~     This study proposes to treat patients with the combination of erlotinib and temozolomide.~     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors~     possess a non-synonymous mutation in EGFR, ERBB2, or JAK2V617F (JAK2) will be eligible for~     the study. Very few phase 2 clinical trials have been performed in pediatrics using targeted~     agents in combination with conventional chemotherapy agents. Furthermore, since some~     combinations such as the combination of this study (erlotinib and temozolomide) have shown~     additive/synergistic effects in preclinical studies, therapy selecting for those patients~     who possess mutations targeted by the TKI of the study, may unveil activity that has not~     been previously observed. Thus, the investigators hope to determine whether the addition of~     additive/synergistic chemotherapy will increase efficacy of target agent and/or increase~     tumor susceptibility to targeted agent resulting in increased anti-tumor activity.~   "
28100|NCT02689323|"~     The purpose of this study is to investigate the modulatory effects of repetitive~     transcranial magnetic stimulation (rTMS) on functional connectivity with the insula.~     Functional connectivity (FC) measures the interaction between brain regions, and recent~     neuroimaging studies have used FC to investigate how addiction affects FC among pertinent~     brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to~     manipulate brain connectivity and could be used therapeutically to treat addiction. However,~     investigators first need more information on brain FC and how it relates to behavior, in~     order to guide rTMS target selection.~   "
28101|NCT02689310|"~     The investigators hypothesize that the use of leptospermum scoparium honey as a type of~     dressing and/or debridement agent on stage III or IV pressure ulcers has an increased~     efficacy and safety compared to the current treatment protocol that includes the use of~     hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care.~     Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as~     a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the~     comparison treatment of standard of care wound dressings. Moreover, this research design~     will enable the research team to determine if the honey based dressings are equivalent to or~     superior to the comparison treatment.~      Therefore, the investigators specific study objectives are as follows:~        1. Primary Objectives: Determine if the use of honey as an alternative treatment will~          reduce site inflammation/irritation and pain associated with pressure ulcers compared~          to the standard treatment options. Specifically, the investigators will monitor patient~          PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue~          progression, length of time to heal, patient pain assessments via the Wong Baker Face~          or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies,~          stinging sensations, bacterial infections that warrant antibiotic intervention, etc.).~        2. Secondary Objective: Patients in the honey treatment group will have lower costs per~          healed ulcer than patients in the standard collagenase treatment group.~   "
28102|NCT02689297|"~     The purpose of the study is to evaluate the effect of various oral hygiene regimes on three~     volatile sulfur compounds.~   "
28106|NCT02689245|"~     Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre~     cirrhotic,compensated,decompensated and reactivation). All the in and out patient with~     Hepatitis B reactivation will be recruited and randomized into two arms.~      Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).~      Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.~   "
28107|NCT02689232|"~     All patients with non variceal bleed who are admitted under the Department of Hepatology at~     Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide~     informed consent.~   "
28108|NCT02689219|"~     This is a Phase II study to evaluate the activity of brentuximab vedotin in~     relapsed/refractory non-seminomatous germ cell tumors (NSGCT).~   "
28109|NCT02689206|"~     GSK1278863 is an orally available, hypoxia-inducible factor - prolyl hydroxylase inhibitor,~     currently being investigated as a treatment for anemia associated with chronic kidney~     disease. GSK1278863 has been given as a once daily regimen in clinical studies to date.~     However, physicians in countries that use a three-times weekly hemodialysis schedule prefer~     to give the anemia medicine at the same time as the dialysis session. This study will test~     how well GSK1278863 can maintain hemoglobin levels when given three-times weekly, for 29~     days.~      This study will describe the relationship between hemoglobin and GSK1278863 given~     three-times weekly. The data from this study will allow for conversion of once daily doses~     to three-times weekly doses.~   "
28110|NCT02689193|"~     The IDIS study aims to develop a new rapid diagnostic test for invasive salmonellosis using~     samples (blood, urine) collected from patients with fever and healthy controls at the~     Institute of Tropical Medicine (ITM) and collaborating centers. The samples are collected~     after informed consent and/or assent is given by the participant and are stored in a -80 ⁰C~     freezer after processing (centrifugation and/or aliquoting). Basic information regarding the~     patient and the samples are coded and stored in a protected Microsoft Access database. The~     samples will be shipped to Belgium for proteomic analysis. Identification of Salmonella~     specific proteins in the samples will hopefully support the development of a rapid~     diagnostic test. Once this test has been developed, the samples will also be used for~     validation and evaluation of this test.~   "
28111|NCT02689180|"~     The ReBIC-1 trial was designed to evaluate the potential clinical risks and benefits of~     withdrawing furosemide use in stable, apparently euvolemic, chronic HF outpatients in a~     multicentric double-blinded randomized clinical trial.~   "
28112|NCT02689167|"~     Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in~     accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will~     be offered participation in this study during the consultation as part of their usual care.~     The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib~     is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks on ~     alternating with 2 weeks off ~      As soon as a dose or schedule adjustment is required, regardless of cause, the patient will~     be randomised 1/1:~        -  Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in~          accordance with the Marketing Authorisation); 4 weeks on  alternating with 2 weeks~          off ~        -  Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen~          (investigational arm); 2 weeks on  alternating with 1 week off ~   "
28113|NCT02689154|"~     The investigators will test a recent mobile technology based (mHealth) behavioral weight~     loss intervention (W8Loss2Go), which is designed for children and adolescents, and uses an~     addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at~     meals. The investigators will test whether this intervention will reduce body mass index~     (BMI), help subjects identify and withdraw from problem foods, eliminate snacking, and~     reduce the amounts of foods consumed at home meals.~   "
28114|NCT02689141|"~     A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of~     a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by~     ibrutinib and ofatumumab maintenance in CLL patients.~   "
28115|NCT02689128|"~     Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and~     anesthesia.~      The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan~     University Hospital over one year period.~   "
28116|NCT02689115|"~     Rheumatoid arthritis (RA) is a systemic and auto-immune disorder whose primary~     characteristic is the chronic inflammation of joints. The objective of this study was to~     evaluate whether there was an association between the NF-KB1/IKK epsilon genetic expression~     and the clinical activity in RA.~      60 RA patients were included in the study, 30 with clinical activity and 30 with clinical~     remission The NF-KB1/IKK epsilon genetic expression was performed by real time quantitative~     Polymerase chain reaction (qPCR) through the Pfaffl method of relative quantification with~     Taqman probes.~   "
28117|NCT02689102|"~     Often, assessing a classifying diagnosis in patients with interstitial lung disease provides~     a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic~     surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with~     suspected ILD. However, tissue acquisition is associated with morbidity in these patients~     with an already compromised pulmonary function. In clinical practice this results in the~     fact that only a minor part of patients with an indication for tissue acquisition are~     actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on~     imagign collected with minimal invasive novel optical techniques, to examine whether the~     addition of novel optical techniques to the diagnostic process of ILD could potentially~     limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of~     biopsies by providing additional information on biopsy location.~   "
28118|NCT02689089|"~     This phase IV clinical study trial will be conducted among persons who require treatment for~     LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study~     is to compare the proportion of people who complete directly observed prophylactic treatment~     (DOPT) using the new 3HP regimen to the current standard of 9 months INH.~   "
28190|NCT02688153|"~     The study purpose is to compare the EDWARDS INTUITY valve system with commercially available~     stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with~     coronary artery bypass.~   "
28119|NCT02689076|"~     Among older VA patients who have Medicare coverage, 43% use both VA and non-VA~     (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters,~     treatments and test results provided in the other system. The overall objective of this~     project is to examine the impact of VA provider notification of non-VA hospitalization or~     emergency department (ED) visit using electronic health information exchange (HIE), along~     with provision of post-hospital care coordination services. The investigators will examine~     the impact of these approaches on preventing hospital readmission, increasing provider~     follow-up, improving patient's self-knowledge, and preventing medication errors. The~     investigators will also examine the effect of these approaches on VA and non-VA costs.~     Finally the investigators will examine the acceptance of these approaches among VA and~     non-VA providers. The study sample will consist of Veterans followed in geriatrics or~     primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The~     investigators will monitor patients for non-VA hospital admission or ED visit using~     technology provided by health information exchange organizations. Patients will be assigned~     to enhanced or control treatment groups. For both groups the VA provider will receive an~     electronic notification of a non-VA hospital admission or ED visit if it occurs. For the~     enhanced group, a care transitions coordinator will deliver post-hospital coordination~     services during a home and/or VA facility visit and follow-up phone calls over 1 month. The~     investigators' analyses will compare effects of notification-plus-coordination versus~     notification-only on health care outcomes. The investigators will conduct interviews with~     intervention team members, patients, VA and non-VA staff, and other stakeholders to~     ascertain the barriers and facilitators to implementation of these approaches.~   "
28120|NCT02689063|"~     The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV,~     acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative~     pain after bunionectomy~   "
28121|NCT02689050|"~     EUS-FNA is the recommended diagnostic examination of choice when patients present with~     suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in~     costs, and although it has a good record in detecting diseases (eg confirm a nodal~     metastasis or granulomas) it has limitations in excluding diseases (missing metastases/ or~     granulomas) resulting in a false negative rate of 15-20%. Substantial limitations that most~     likely can be attributed to areas within the node that are not sampled during EUS-FNA tissue~     acquisition. Improved needle based EBUS/ EUS guided nodal diagnostics might result in~     improved quality of the fine needle aspirations, reduce in surgical diagnostic procedures ,~     reduced costs and result in a shorter timebefore-treatment interval.~   "
28122|NCT02689037|"~     Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on~     prevention of events of stroke and death in patients with symptomatic intracranial~     atherosclerosis (ICAS) is controversial.~      Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in~     preventing events of stroke and death in patients with symptomatic ICAS.~      Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in~     China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT~     group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily)~     immediately after randomization, and patients in PTAS+MT group will receive surgery within 5~     days after randomization. The patients will be followed up for 1 year after randomization~     and assessed for events of stroke and death at 30 days and 1 year after randomization, the~     incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30~     days and 1 year after randomization, incidence of in-stent restenosis at 1 year after~     randomization,etc.~   "
28123|NCT02689024|"~     A broken hip occurs frequently in elderly patients and is often very painful. Side effects~     of inadequately treated pain as well as the traditional drugs (administered through~     intravenous catheter) used to treat pain are, among others, a confusional state, called~     delirium. When pain medication is administered locally, only around the hip joint, pain~     might be treated more effectively and these side effects could be prevented. This is called~     a nerve block.~      The current study evaluates the use of a continuous nerve block throughout the complete~     hospital admission with a catheter around the hip joint versus the use of traditionally used~     pain medication administered though an intravenous catheter in elderly patients with a~     broken hip. Half of all patients will receive the nerve block while in the emergency~     department and the other half will receive pain medication through the intravenous access.~   "
28124|NCT02689011|"~     This study aims to compare the incidence of urinary retention and requirement of bladder~     catheterization in patients undergoing total knee arthroplasty while receiving either~     continuous epidural analgesia or single shot femoral nerve block.~   "
28125|NCT02688998|"~     In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method~     to allow comparisons of established standard of care vascular access strategies using the~     integrated consent model as part of a pragmatic clinical trial.~      Determining the optimal vascular access strategy remains an important medical issue for~     patients, nurses, physicians and society. A novel method to allow comparison of established~     standards of care is needed as part of an increasing internationally mandated incentive to~     perform more pragmatic clinic trials.~   "
28126|NCT02688985|"~     This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in~     order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS.~     Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on~     Days 1 and 15. Subsequent doses will be given as single 600-mg infusions. Participants will~     be randomized to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52.~   "
28127|NCT02688972|"~     Football is a sport with congested calendars, which requires muscle recovery strategies such~     as cold water immersion (CWI). This recovery technique is well spread through football~     clubs, although it lacks a profound physiologic investigation to understand its effects on~     athlete's body. Objectives: The main objective of this study is to evaluate the effect of a~     long-term CWI exposure in football athlete's.~      Study Hypothesis:~      H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph~     signal, power and perceived of recover when compared with control sample.~      H1: The application of Cold water immersion amends the biomarkers, electromyograph signal,~     power and perceived of recover when compared with control sample.~   "
28128|NCT02688959|"~     The investigators will perform a feasibility/pilot trial of two non-pharmacological~     interventions for ADHD in college students.~   "
28215|NCT02687828|"~     This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal~     Behcet's disease (BD) patients in routine clinical practice.~   "
28216|NCT02687815|"~     This study will determine whether vitamin D3 prevents severe asthma attacks in children who~     have a serum vitamin D (25(OH)D) level <30 ng/ml and who are being treated with inhaled~     corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000~     IU/day, and the other half will receive placebo.~   "
28129|NCT02688946|"~     Rationale: The interaction between macro and microcirculation remains uncertain.~     Microvascular alterations can occur when systemic hemodynamic parameters are within an~     acceptable range. Perfusion changes and microvascular alterations may play an important role~     in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery.~     Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to~     anastomosis creation. However, local oxygen delivery may still be compromised as little is~     known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field~     (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging~     modality incorporated in a hand-held device, which illuminates an area of interest and~     provides high contrast dynamic images of the microvasculature. DF-imaging enables to~     visualize the bowel's microcirculation.~      Objective: To describe the human gastrointestinal microcirculation during gastrointestinal~     surgery under general anesthesia and to observe whether there is a correlation between bowel~     microcirculation and systemic hemodynamic parameters.~      Study design: A prospective, single center, observational, clinical, pilot study.~      Study population: 70 patients undergoing elective, gastrointestinal surgery during which the~     gastrointestinal tract is accessible for DF-imaging.~      Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both~     the serosal and mucosal side of the bowel during gastrointestinal surgery under general~     anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular~     Flow Index (MFI).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The extend of burden and risk associated with participation is negligible.~     Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time~     as is described in the study procedure. Previous studies did not show any safety concerns.~     Measuring will be performed under sterile conditions and the occurrence of tissue damage is~     highly unlikely. Patients are under general anesthesia and will thus not experience any~     inconvenience.~   "
28130|NCT02688933|"~     Primary Objective:~      To demonstrate that morning injection of Toujeo compared to Lantus will provide better~     glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult patients with~     type 1 diabetes mellitus.~      Secondary Objective:~      To demonstrate that treatment with Toujeo compared to Lantus will provide:~        -  Lower incidence rate of nocturnal symptomatic hypoglycemia;~        -  Better glucose control coverage during the last hours of CGM before next basal-insulin~          dosing;~        -  Less variability in CGM profile.~   "
28131|NCT02688920|"~     This observational study is conducted to determine how the duodenal layer thicknesses~     (mucosa, submucosa, and muscularis) vary with several factors in patients with and without~     type 2 diabetes.~   "
28132|NCT02688907|"~     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein~     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2~     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.~      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase~     of the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the~     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).~      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced~     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic~     cytotoxic effects when administered in combination with various DNA damaging agents that~     have divergent mechanisms of action. Therefore, the primary objective of the clinical~     development of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic~     agent (or combination of agents) for treatment of advanced solid tumors.~      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is~     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause~     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA~     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775~     will have independent anti-tumor activity in the absence of added chemotherapy.~      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human~     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase~     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may~     selectively sensitize p53-deficient cells.~      One hundred percent of SCLC has TP53 mutation, therefore we can expect that most of SCLC~     have lost G1 checkpoint and has high probability of WEE1 dependency for proper DNA repair~     and cell cycle progression. For this reason, SCLC could be a good clinical trial target~     disease for WEE1 inhibitor.~   "
28133|NCT02688894|"~     This protocol is a molecular screening protocol only. No drug intervention study will be~     included in this protocol. Based on the molecular profiling, patients may be eligible for~     drug intervention study of SUKSES trial.~      This procedure can be performed during or after the first-line treatment. DNA will be~     extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring~     CNV will be tested with DNA from tissue and/or blood.~      Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.~      Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring~     CNV, immunohistochemistry and/or FISH.~      Specific methods of each molecular tests will be defined with standard laboratory manual~     developed by pathologists.~   "
28134|NCT02688881|"~     This study is a single arm, pilot study of sirolimus in patient with~     Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway~     aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar~     scan that has progressed following standard therapy or that has not responded to standard~     therapy or for which there is no standard therapy.~      sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of~     sirolimus in patient with Refractory solid tumor.~   "
28135|NCT02688868|"~     The purpose of this study is to evalute the clinical safety and effectiveness of released~     specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.~   "
28136|NCT02688855|"~     The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or~     females that have sustained a closed, unstable ankle fracture that requires surgical~     treatment for stabilization. The initiation of the adjunctive treatment is to begin within~     11 days of surgical stabilization.~   "
28137|NCT02688842|"~     The purpose of this study is to evalute the clinical safety and effectiveness of released~     specification (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.~   "
28138|NCT02688829|"~     This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of~     Microport for the first time to assess the preliminary safety and feasibility used in the~     human body. And provide evidence for subsequent large-scale, multi-center, randomized~     controlled clinical trials, then provide the basis for the formal application of the product~     in China.~   "
28139|NCT02688816|"~     This study will compare the test performance characteristics of visual inspection with~     acetic acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible~     inclusion of these molecular tests in future cervical cancer screening~   "
28217|NCT02687802|"~     The objective of the study is to estimate the incidence of asynchrony and to assess its~     relationship with respiratory mechanics. This will be a prospective cohort study, including~     patients under invasive mechanical ventilation. Within 48h post intubation, the~     investigators will record the values of intrinsic positive end-expiratory pressure,~     pulmonary compliance and resistance. Participants will be followed up from intubation to~     mechanical ventilation liberation. The investigators will register clinical signs of~     asynchrony and record ventilator waveforms continuously and quantify patient-ventilator~     asynchrony. The investigators will calculate the total asynchrony index (AI) and of each~     asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling~     and prolonged cycling). Participants will be followed up until hospital discharge.~   "
28140|NCT02688803|"~     Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1%~     expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over~     express HER2.~      TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and~     have biologically more aggressive high grade disease. Clinically, patients with TNBC have a~     poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because~     of the aggressive phenotype and due to observations that systemic chemotherapy offers~     significantly higher benefit in ER negative disease, current treatment guidelines from~     provincial and other organizations recommend that patients receive adjuvant systemic~     chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive~     independent of primary tumor size.~      Currently, there is no world-wide standard recommended chemotherapy regimen for the~     management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region~     and institution.~      As physicians do not know what the best treatment for patients is, genuine uncertainty~     (clinical equipoise) exists. Physicians will choose between different standards in their~     personal practice, using idiosyncratic decision making processes, without the physician or~     the patient knowing the optimal option. This is not good for patients, physicians and~     society as a whole. Determining the optimal treatment remains an important medical issue for~     patients, physicians and society. This study will survey opinions on a novel method to allow~     comparisons of established standard of care prophylactic treatment using the integrated~     consent model as part of a pragmatic clinical trial and attempt to compare head to head~     standard chemotherapy regimens in patients with TNBC.~   "
28141|NCT02688790|"~     The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single~     intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability~     of a single dalbavancin IV infusion.~   "
28142|NCT02688777|"~     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing~     an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88~     million for follow-up care over 6 months post-stroke. Contributing to these costs is the~     incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to~     an increased incidence of fractures, depression, and mortality. New strategies are needed to~     help Veterans post-stroke regain their ability to safely walk without increasing their risk~     of falling as well as readily identify those who are a fall risk. This study addresses both~     of these needs as it will 1) investigate a new treatment approach, backward walking~     training, to determine if it will decrease fall incidence in the first year post-stroke and~     2) determine if backward walking speed early after a stroke can identify those that are at~     risk for future falls.~   "
28143|NCT02688764|"~     This a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study~     to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®)~     in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3~     clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and~     adolescent patients with CKD, and to provide safety and dosing information for this patient~     population. The Phoslyra (comparator) group provides information for a descriptive~     comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).~   "
28144|NCT02688751|"~     A single site cross-sectional comparison of paired diagnostic imaging modalities.~      This study will show the sensitivity and specificity of CEUS in detecting the various types~     of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow~     comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will~     collect time taken to perform the various types of scan, to allow healthcare costs to be~     calculated for each imaging modality.~   "
28145|NCT02688738|"~     The purpose of this study is to evaluate the ability of oral doxycycline to decrease the~     colonization of Propionibacterium acnes in the dermis of the shoulder.~   "
28146|NCT02688725|"~     Currently, there is no standard recommendation for using imaging studies to check patients~     for breast cancer recurrence who have been treated with mastectomy. The investigator~     proposes performing in-office ultrasound examinations of these patients to determine if this~     would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences~     following mastectomy.~   "
28147|NCT02688712|"~     The purpose of this study is to see how effective and safe LY2157299, in combination with~     chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this~     study, research will be done on tumor samples to see if it is possible to predict if~     patients will respond to treatment, and blood samples to look at the immune system response~     to study treatment.~      About 50 people will take part in this study. The study treatment will be given over an 8~     week period and the investigators will continue to collect your health information for up to~     5 years, as part of this study~   "
28148|NCT02688699|"~     The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in~     preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD~     (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon~   "
28149|NCT02688686|"~     The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic~     cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with~     Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected~     Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and~     Survivin,are used for DC-based immunotherapy. Based on the results of our previously~     preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform~     the clinical trial.~   "
28150|NCT02688673|"~     The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC)~     combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage~     Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin~     transfected DC, which are used for DC-based immunotherapy. Based on the results of our~     previously preclinical research with DC combined with CIK cells, the investigators plan to~     perform the clinical trial.~   "
28232|NCT02687607|"~     An observational non-randomized, multi-center, prospective assessment of the clinical~     utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial~     aneurysms deemed appropriate for endovascular treatment. The population being treated in~     this Registry is a subset of the CE marked indication.~   "
28151|NCT02688660|"~     Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each~     year in the United States, pediatric TBI results in an estimated 630,000 emergency room~     visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability~     after severe TBI is high, with over 60% of children requiring educational or community based~     supportive services 12 months post-injury. Over 5,000 children require inpatient~     rehabilitation after TBI each year and an estimated 145,000 US children are currently living~     with disabilities after a severe TBI. Hospital costs for the acute treatment of children~     with TBI are estimated at ~$2.6 billion each year, while the gross annual costs accounting~     for long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a~     major public health concern and new ways to diagnose and treat TBI are urgently needed.~   "
28152|NCT02688647|"~     This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg~     of KD025 once-daily (QD) compared to standard of care (SOC) in male and~     postmenopausal/surgically sterilized female subjects with IPF.~   "
28153|NCT02688634|"~     Cleft Lip and Palate surgical repair is one of the most common procedures performed by~     Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no~     consensus exists regarding the usage of postoperative antibiotics or the effects this might~     have on wound complications such as cellulitis, dehiscence, or fistula formation. The~     surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological~     organisms, indeed the human bite is one of the more clinically and microbiologically~     significant injuries to treat. This research study is to elucidate the role, if any, that~     prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and~     VPI repair and potentially establish a new paradigm of care.~   "
28154|NCT02688621|"~     The investigators propose a randomized controlled trial to evaluate whether the addition of~     financial incentives to a high-quality, online behavioral weight loss intervention produces~     better weight losses than the online treatment alone.~   "
28155|NCT02688608|"~     This study is being done because there are currently no approved and no commonly working~     targeted therapies in anaplastic thyroid cancer (ATC). This is an area of urgent need for~     patients, not just for approved treatments but also rationally-designed clinical trials~     designed specifically for ATC. Patients diagnosed with anaplastic thyroid cancer have a very~     high likelihood of dying because of their disease. As such there is a clear need for~     improving therapy for ATC.~   "
28156|NCT02688595|"~     The purpose of this study is to compare the differences in central venous catheter insertion~     time, success rate, and complication between the Seldinger and modified Seldinger technique~     for ultrasound-guided central venous catheterization in neonates.~   "
28157|NCT02688582|"~     For this study, a previously developed population pharmacokinetic (popPK) model for cefepime~     (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software~     program to drive an infusion pump. By entering patient data (such as gender, serum~     creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and~     given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of~     this study is to prospectively validate the popPK model using TCI.~   "
28158|NCT02688569|"~     This randomized controlled clinical trial will examine the effects of Cognitive Behavioral~     Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia.~      Specific Aims:~        1. To examine the clinical and health characteristics, including sleep, pain, fatigue,~          cognitive abilities, and cardiovascular health in patients with comorbid CWP and~          insomnia.~        2. To examine changes in the primary clinical outcomes, including chronic pain, complaints~          of poor sleep, and fatigue compared to the waitlist control (WLC).~        3. To examine changes in the secondary clinical outcomes, including mood, daytime~          functioning, cognitive functioning, and cardiovascular health compared WLC.~        4. To examine the mechanistic variables, including arousal (heart rate variability, HRV),~          CS (thermal response) and neural plasticity (brain function and structure) - compared~          to WLC.~   "
28159|NCT02688556|"~     This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of~     OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis~     sicca to be conducted at approximately 50 sites.~   "
28160|NCT02688543|"~     Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be~     inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a~     solution, but waiting lists may be long or certain patients may not be apt for a surgical~     intervention. Therefore an alternative pain treatment that is effective and has little side~     effects allowing to offer pain relief to those difficult to manage patients would be an~     added value in the therapeutic options.~      We studies the short and long-term effects of radio frequency treatment of the genicular~     nerves in patients with severe pain due to osteoarthritis of the knee.~   "
28161|NCT02688530|"~     For surgery involving the shoulder, anesthesiologists will often inject local anesthetic~     numbing medication near nerves supplying the shoulder in what is called a supraclavicular~     nerve block. These nerve blocks cause numbness and weakness in the shoulder leading to~     relaxation of the joint which is helpful to the surgeon and allowing for painless surgery~     without general anesthesia. After surgery, pain relief is sustained for the duration of the~     nerve block.~      The primary purpose of this study is to clarify the duration of pain control provided by~     supraclavicular blocks when supplemented with varying doses of the steroid anti-inflammatory~     dexamethasone when given through the intravenous line (IV). IV dexamethasone is commonly~     used for both nausea prevention and block prolongation, but a detailed study of the effect~     of varying doses of this medication on duration of pain relief and weakness from the block~     has not been studied. The study investigators seek to identify what association, if any, is~     noted between IV dexamethasone doses and changes in blood glucose levels after shoulder~     surgery with regional anesthesia and sedation. Finally, the study investigators will collect~     data on side-effects and postoperative complications, if any, in patients receiving a range~     of doses of IV dexamethasone.~   "
28162|NCT02688517|"~     This research trial studies the use of targeted genomic analysis of blood and tissue samples~     from patients with cancer. Genomic sequencing is a laboratory method that is used to~     determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing~     can be used to find changes in areas of the genome that may be important in the development~     of cancer. It may also help doctors improve ways to diagnose and treat patients with rare~     cancers with poor prognosis or lack of effective therapy.~   "
28163|NCT02688504|"~     In France, drugs affecting driving ability directly or by indicating at-risk diseases are~     classified in a 4-level standardized classification associated with a graded pictogram.~      When the French authorities required this graded pictogram, they commissioned the CESIR-U1~     study, a study designed to describe the use of labelled medicines by drivers involved in~     serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges~     and Toulouse, recruited 679 drivers involved in serious road accidents. When the~     responsibility of the driver is taken into account, it appears that the association of risk~     factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility.~     Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did~     not reach significance.~      This conclusion is different from the conclusion of CESIR-A, a data linkage study of the~     police and the health insurance databases which showed a correlation between the use of~     grade 2 or 3 labelled medicines and driver responsibility.~      This difference between CESIR-U and CESIR-A could be related to a lack of power or to the~     characteristics of the subjects included (mostly young men and motorcycle drivers). That is~     why it was thought interesting to increase the size of the sample and to include non serious~     road accidents (hospitalization < 24 hours) that represent around 73% of accidents.~   "
28164|NCT02688491|"~     Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive~     adjuvant targeted therapy or not is still on debate. The investigators invented a assay~     consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000~     （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear~     cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93.~     Here the investigators randomly assign assay-defined high risk patients of locally advanced~     ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and~     overall survival are the end points of observation.~   "
28165|NCT02688478|"~     Phthalates are commonly used plasticizers that have been linked to asthma in epidemiological~     studies. The investigators are researching effects of phthalates on airway immunology and~     lung function, and on allergic responses by doing an inhaled allergen challenge. After~     exposing participants to either filtered air or carefully controlled levels of phthalate in~     our exposure chamber we will collect samples from the nose and the upper airways, by rinsing~     the nose with saltwater or performing small brushings. The investigators will also collect a~     bronchial samples by bronchoscopy after each exposure. After 2 weeks, the entire procedure~     will be repeated with the alternate exposure.~   "
28166|NCT02688465|"~     Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms~     that complicate and impair patients' quality of life. Among those disorders are sleep~     disorders.~      Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and~     long periods of awakening which occupy 30 to 40% of their night.~      Apomorphine is a dopamine agonist that may be administered with a pump . The objective of~     the study is to assess changes in the quality of sleep in Parkinson's disease patients~     treated with an apomorphine pump.~   "
28167|NCT02688452|"~     The primary purpose of this interventional, placebo controlled, crossover, double blind,~     basic science exploratory study is to investigate whether there is a difference in brain~     electrophysiological oscillatory activity in healthy adults before and after oral~     consumption of water containing very small bubbles of oxygen (electrokinetically modified~     water).~   "
28168|NCT02688439|"~     The primary purpose of this study is to determine whether the leg positioning or distal~     tourniquet used during the injection of local anesthetic may decrease the onset time and~     prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with~     popliteal approach. Patients will be divided randomly into three groups: group 1 will~     receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control~     group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of~     the foot over a support placed on the OR table and maintained in that position for 15 min;~     and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on~     the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the~     ankle) with the leg in a neutral position~   "
28169|NCT02688426|"~     The low-level laser therapy (LLLT) has been used in many inflammatory disorders.~      More recently the LLLT was associated with an improvement in the muscle strength, endurance~     and functional capacity.But, these effects were described only in health or athletic~     individuals. In this randomized and controlled clinical trails, the investigators will study~     the effects of LLLT on functional capacity of the patients with Coronary artery bypass~     surgery.~   "
28170|NCT02688413|"~     Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality~     based system for upper limb motor rehabilitation in early post-stroke patients. The study~     aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation~     dose. Effectiveness will be evaluated by validated rehabilitation performance scales.~     Cost-effectiveness will be assessed by the resource utilization.~   "
28171|NCT02688400|"~     Osteoarthritis (OA) of the knee is the most frequent cause of knee pain after the age of 50~     years. OA is a joint disease characterised by articular cartilage loss associated with~     structural changes in the cartilage and adjacent structures. The main symptoms are pain and~     functional disability. The goals of OA therapy are to decrease pain and maintain or improve~     joint function. There is evidence that diacerein has both a symptomatic and a structural~     effect on cartilage, and clinical studies suggest that diacerein therapy significantly~     decreases OA symptoms when compared to placebo. Diacerein has been shown to inhibit~     interleukine-1 (IL-1β), and down-regulated IL-1β stimulated secretion of metalloproteinases~     and aggrecanases, and thereby prevent breakdown of cartilage by these enzymes. Diacerein has~     no effect on the synthesis of prostaglandins, and therefore no effect on the upper~     intestinal tract. The purpose of this phase III-IV international, multicentre, double-blind,~     non-inferiority, randomised, controlled study is to determine the efficacy and safety of~     diacerein vs. celecoxib on symptoms after 6 months of treatment, and on structural changes~     after 2 years of treatment in knee OA patients as assessed by magnetic resonance imaging~     (MRI).~   "
28245|NCT02687438|"~     Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL~     mini implants immediately following ethmoid sinus surgery~   "
28172|NCT02688387|"~     This study is designed to understand the relative bioavailability (proportion of the~     administered dose that is absorbed into the bloodstream) of several fixed dose combinations~     (FDCs) tablets of ambrisentan and tadalafil for further development and to provide~     pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal~     bioequivalence (BE - the relationship between two preparations of the same drug in the same~     dosage form that have a similar bioavailability) study. Depending on formulation work, the~     study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and~     tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that~     may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in~     both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open~     label crossover study with 3 study parts; each study part will have up to a 5 way crossover~     in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC~     (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy~     components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated.~     If successful formulations are identified in this part of the study, then they will be~     re-formulated and tested in part 2. If no successful formulations are identified in part 1~     of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However,~     if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be~     tested both fed and fasted to assess food effect and part 3 will not be required. If~     successful formulations are identified in this study part, then up to 2 of these may be~     tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3~     is optional and utility is dependent on the results of the previous study parts.~   "
28173|NCT02688374|"~     This is a randomized, open-label, single-dose, three-period, crossover, single-center~     comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult~     participants with a history of cigarette smoking. The participants will be admitted to the~     investigational clinic at least 38 hours before dosing and will remain domiciled until the~     completion of all study procedures at approximately 24 hours after dosing. Three toothpastes~     (one is commercial non-medicated non-nicotine containing chewing gum and other two are~     nicotine containing gums) will be provided across the 3 treatment periods. During each of~     the 3 treatment periods, participants will be under supervision in a non-smoking area and~     will abstain from smoking.There will be a total of at least 7 days and not more than 10 days~     (clinical furlough period) between treatment periods. Twenty (20) blood samples will be~     collected for pharmacokinetic (PK) analysis at baseline and multiple time points following~     study drug administration. The trial duration will be approximately 49 days and up to 55~     days from screening to study end including the screening period.~   "
28174|NCT02688361|"~     This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose~     crossover design study in adult male and female healthy participants. Eligible participants~     will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200~     mg N- acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral~     solution, 200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48~     hours in each period. After completion of the second study period (i.e. last pharmacokinetic~     (PK) sample on Day 3 of Period 2) participants will be discharged from the clinic.~   "
28175|NCT02688348|"~     This research trial studies quality of life after bladder-preservation chemotherapy and~     radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into~     or through the muscle layer of the bladder (muscle-invasive bladder cancer).~     Bladder-preservation chemo-radiotherapy is a standard treatment for patients with~     muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel,~     and sexual late side effects that negatively affect patients' quality of life. Studying~     quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may~     help identify the long-term side effects of treatment and may help plan the best treatment~     in the future and improve patients' quality of life.~   "
28176|NCT02688335|"~     This is an interventional study in which patients with a history of habitual snoring will~     use the low-pressure CPAP device at home for about 2 weeks. This study is designed to~     document the adherence of the snorer, the acceptance and comfort of the therapy, and bed~     partners' subjective report of improvement in sleep quality, and/or reduction or elimination~     of snoring. Study outcomes will consist of an assessment of the nightly usage time, and~     questionnaires that the snorer and the bed-partner have to complete before the start of the~     study, after two night's treatment, and at the end of the study period.~   "
28177|NCT02688322|"~     Acinetobacter species have emerged as agents of serious nosocomial infections in critically~     ill patients. Only a few effective antibiotics are currently available for the treatment of~     this pathogen and, therefore, sulbactam is being considered as an alternative treatment~     option. The aims of this study were to i) reveal the population pharmacokinetics and ii)~     assess the probability of target attainment (PTA) of sulbactam in septic critically ill~     patients caused by Acinetobacter spp. infections.~      The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each~     patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were~     carried out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to~     determine the probability of attaining a specific pharmacodynamic target.~   "
28178|NCT02688309|"~     This study will examine potential factors in the aqueous humor that may contribute to the~     development or progression of macular edema or fibrosis (due to any underlying disease) in~     patients suffering from these conditions.~   "
28179|NCT02688296|"~     The objective of this post-market clinical study is to evaluate efficacy outcomes and~     complication rates in patients who have received the Fibulock™ Intramedullary Nail.~   "
28180|NCT02688283|"~     The objective of this trial is to compare a snack with ingredients (whole grains and dietary~     fiber) to slow carbohydrate digestion to a similar control snack without such ingredients~     and evaluate the effect of the snack on glycemic response and subjective satiety. The test~     product will be compared with a control product as well as white bread in a randomized,~     controlled, crossover trial including 20 healthy males or females between the ages of 18 and~     70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast,~     participants will be given each of the study products in a random order at least a week~     apart. Glucose and insulin will be measured before product consumption and over a period of~     four hours. Visual analog scales to measure subjective satiety will also be administered~     over a period of four hours.~   "
28181|NCT02688270|"~     The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical~     cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon.~     The symptoms of this disease include pain, tingling, and numbness in the fingers of the~     affected hand or hands.~   "
28246|NCT02687425|"~     The purpose of this study is to assess the safety and efficiency of adding pioglitazone to~     chronic phase chronic myelogenous leukemia patients having received imatinib mesylate who~     have acquired a stable molecular response but not complete molecular response.~   "
28182|NCT02688257|"~     Patients with large primary operable breast cancers are offered chemotherapy prior to~     surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment~     of response to chemotherapy relies on a change in tumour size which does not always~     correlate with the change in amount of viable tumour. Newer techniques such as functional~     MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to~     chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither~     modality utilises ionising radiation.~      Although MRI is widely used for detecting breast cancer, its ability in assessing functional~     responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast~     enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of~     blood volume and flow. Other functional techniques detect variation in tissue oxygenation:~     this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a~     special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of~     deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements~     which relate to oxygenation of a tumour. The investigators also want to validate other MR~     sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood~     in the capillary network and the diffusion of water within tissues.~      Microbubble ultrasound is an established technique that utilises an intravenous contrast~     agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and~     enhance spectral and colour Doppler signals obtained from routine ultrasound imaging.~     Optoacoustic imaging is new technique where the output signal depends on the oxygenation of~     the tissues under study. It utilises a light signal input and measures ultrasound signal~     output.~      The investigators want to correlate our imaging findings with histopathology after surgical~     resection of the tumour.~   "
28183|NCT02688244|"~     This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in~     complicated acute appendicitis performing irrigation of the abdominal cavity or only suction~     without lavage.~   "
28184|NCT02688231|"~     An adequate upper limb function is crucial to independently perform Activities of Daily~     Living (ADL). Persons with neurological diseases often experience upper limb dysfunction.~     Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall~     disability level, while the detrimental impact on ADL is higher than in stroke, given that~     symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar~     rehabilitation principles and effect sizes apply in MS given that this progressive~     neurodegenerative disease is characterized by multiple lesions and atrophy of brain~     structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not~     known in the MS literature neither were characteristics of responders identified.~      The aim of this explorative study is to investigate the intensity dependent clinical effects~     of a task-oriented upper limb training in persons with MS with different upper limb~     disability levels.~   "
28185|NCT02688218|"~     The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during~     exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance~     to pursue physical activity, in order to avoid the discomforting symptoms associated with~     hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of~     insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to~     revolutionize the management of this disease. The investigator's group has recently~     completed a study of the bi-hormonal artificial pancreas system during exercise, suggesting~     reduced hypoglycemia around the exercise period. In order to prepare for a future home~     study, the ability to detect, grade, and classify physical activity so as to appropriately~     adjust system parameters is vital in helping to prevent exercise induced hypoglycemia in the~     home setting.~      This study is designed to collect 3-axis accelerometry data and heart rate data during a~     variety of different home activities, as well as during formal exercise in both healthy~     subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the~     change in glucose levels before and after exercise in subjects with type 1 diabetes.~   "
28186|NCT02688205|"~     Shoulder problems cause substantial disability in daily living, work, leisure activity, and~     exercise. The presence of shoulder problem such as rotator cuff pathology reported was~     highly predictive of impaired health-related quality of life.~      Many tests were used for physical examination of the shoulder. The reliability and validity~     of the tests have been studied before. However, a systemic review concluded that there was~     conflicting evidence in reliability of each or combined tests. Functional examination of the~     shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It~     includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.~      As far as the investigators know, correlation of Cyriax functional examination with the~     ultrasonographic findings has never been reported before. Therefore, the aim of this study~     is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound~     findings in patients with shoulder pain.~   "
28187|NCT02688192|"~     This clinical trial studies a mobile health fitness program for adolescent and young adult~     childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at~     risk to have negative late effects from treatment and to develop chronic health conditions.~     A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and~     early mortality. Physical activity reduces the risk for cardiovascular disease and early~     mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body~     composition, and it is also positively associated with quality of life. Programs and~     technologies that promote physical activity are important because health behaviors adopted~     by adolescent and young adult childhood cancer survivors are likely to continue into~     adulthood. A mobile health fitness application may motivate adolescent and young adult~     childhood cancer survivors to engage and maintain physical activity.~   "
28188|NCT02688179|"~     Up to 50% of patients over 60 years old develop postoperative delirium following cardiac~     surgery. Delirium increases morbidity and mortality, and may lead to long-term cognitive~     impairment similar to patients with a diagnosis of Alzheimer's disease. The underlying~     mechanisms behind delirium are not understood, and therefore the current prevention and~     treatment strategies are inadequate. Several hypotheses exist for the pathophysiology of~     delirium, one of which is the role of neuroinflammation. The stress associated with~     high-risk procedures such as cardiac surgery may lead to systemic inflammation causing~     endothelial dysfunction and disruption of the blood brain barrier (BBB). When this occurs,~     the brain is susceptible to neuronal injury via neuroinflammation after which a state of~     delirium may ensue. To characterize the mechanisms of neuroinflammation in delirium, the~     investigators will explore the biomarkers most closely linked to each step of the proposed~     pathway.~   "
28189|NCT02688166|"~     This research study can help understand how cardiac changes may occur with radiation therapy~     to the heart based off measurements obtained through biomarkers and cardiac imaging.~      Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac~     magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac~     function and injury. The cardiac biomarkers that will be tested are effective in the~     diagnosis, risk-stratification, and monitoring of heart failure.~   "
28191|NCT02688140|"~     Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML)~     characterized by consistent clinical, morphologic, and genetic features. According to the~     FAB classification APL is designated asM3 leukemia and assigned to the WHO defined type of~     AML with recurrent cytogenetic abnormalities, acute promyelocytic leukemia with~     t(15;17)(q22;q12), (PML/RARα) and variants.~      Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus~     anthracycline-based regimens, relapses still occur in approximately 20% of patients.~     Moreover, these regimens are associated with significant toxicities due to severe~     myelosuppression frequently associated with life-threatening infections and potentially~     serious late effects including development of secondary MDS/AML. In a recent randomized~     clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of~     arsenic trioxide (ATO) and ATRA has been shown to result into better survival with~     significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA)~     therapy. Inspired by the results of this trial the investigators intend to perform a~     randomized study in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard~     AIDA-based treatment with ATO/ATRA combination including low-doses idarubicin during~     induction. The investigators propose a modified ATO/ATRA protocol with the addition of two~     doses of IDA (50% compared to standard AIDA induction) for induction because of the~     anticipated need of adding anthracyclines to control hyperleukocytosis and to achieve~     long-term disease control in this high-risk APL population. This is followed by 4 cycles of~     ATO/ATRA consolidation therapy. As in the APL0406 study for low/intermediate-risk patients~     the investigators expect less severe hematologic toxicity and treatment-related mortality~     resulting in an improved outcome for patients in the experimental arm. Furthermore, from the~     start of consolidation, these patients (in contrast to the standard arm) can be treated on~     an outpatient basis, which is also considered to be associated with an improved quality of~     life. The study will be conducted as a European intergroup study.~   "
28192|NCT02688127|"~     This study evaluate role of tranexamic acid in reducing blood loss among pregnant women~     undergoing cesarean section because of placenta previa .Half of participants will receive~     tranexamia acid drug While the other half will receive placebo.~   "
28193|NCT02688114|"~     Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's~     esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after~     successful RFA treatment in approximately 1/3 of patients. The aim of this study is to~     characterize the healing process of the esophageal mucosa, histologically and at the~     molecular level, after RFA for non-dysplastic Barrett's esophagus.~   "
28194|NCT02688101|"~     Multicenter, open-label, dose-escalation and pharmacokinetic study.~   "
28195|NCT02688088|"~     This study is known as a drug interaction study and is being done to see how abemaciclib~     may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,~     dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each~     participant will complete screening and four study periods, with the option to continue to~     receive abemaciclib in a safety extension phase. All participants will complete a safety~     follow-up.~   "
28196|NCT02688075|"~     The purpose of this study is to evaluate canagliflozin use in the treatment of type 2~     diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and~     patient-reported outcome (PRO) in a usual clinical practice in Canada.~   "
28197|NCT02688062|"~     The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold~     with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and~     complete spinal cord injury, compared to the treatment of surgical intradural decompression~     and adhesiolysis only.~   "
28198|NCT02688049|"~     The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or~     neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal~     cord injury.~   "
28199|NCT02688036|"~     The purpose of this study is to determine whether hypofractionated concurrent~     chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent~     chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.~   "
28200|NCT02688023|"~     Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of~     this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin,~     irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with~     resectable colorectal cancer.~   "
28201|NCT02688010|"~     Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that~     safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which~     has been rarely achieved. High intensities of noise have several negative effects on preterm~     newborns. Also, they are exposed to either continuous bright light continuous near darkness~     or unstructured combination of the two during their hospitalizations. The investigators~     primary objective is to determine the impact of reduced noise levels and cycled light on~     growth parameters and visual development in preterm infants.~   "
28202|NCT02687997|"~     Prospective study of sleep disordered breathing in a lung cancer screening cohort.~   "
28203|NCT02687984|"~     Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2~     different molecular weights (MW) (low and high MW as test treatments) of poly~     (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to~     intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in~     subjects with stable schizophrenia.~      Secondary Objective:~      To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH~     polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW~     polymer in subjects with stable schizophrenia.~   "
28204|NCT02687971|"~     The purpose of this trial is to determine the efficacy and safety of a combined therapy~     using thermotherapy (TT) (one session, 50 degrees Celsius for 30) + miltefosine at a~     standard dose of 2.5 mg/kg/day for 21 days for the treatment of uncomplicated CL in Peru and~     Colombia~   "
28205|NCT02687958|"~     Cisplatin and Etoposide is the standard of care in NEC originating from the~     gastro-intestinal tract and lung, based on retrospective studies.~      Nevertheless the prognosis of this group of patients is still poor with median survival of~     less than 20 months.~      Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated~     to be active in patients with well and moderately differentiated primitive neuroectodermal~     tumor (pNET).~      Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR)~     pathway is overexpressed in NEC.~      Based on the activity of Everolimus in the treatment of patients with well and moderately~     differentiated p-NET and on the evidence that even poorly differentiated forms express the~     pathway of m-TOR is conceivable that Everolimus could be active even in NEC.~   "
28206|NCT02687945|"~     The purpose of this study is to determine if outpatient physiotherapy results in improved~     and/or more rapid achievement of functional outcomes and quality of life in comparison to~     those patients who do not undergo outpatient physiotherapy after total hip arthroplasty~   "
28207|NCT02687932|"~     Functional MR is caused by adverse left ventricular remodeling after myocardial injury and~     associated with an increased incidence of heart failure and death. Because secondary~     functional MR usually develops as a result of LV dysfunction, diuretics, beta blockers,~     angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), and~     aldosterone antagonists are given to patients with functional MR in line with the guidelines~     in the management of heart failure. However, functional MR appears to remain common despite~     use of these drugs and current medical treatment is usually insufficient for reducing MR or~     reversing the adverse LV remodeling. As LCZ696 is a dual-acting inhibitor of the~     renin-angiotensin-aldosterone system (RAAS) and neutral endopeptidase (NEP), LCZ696 has~     greater hemodynamic and neurohormonal effects than ARB alone. Investigators try to examine~     the hypothesis that LCZ696 is superior to ARB alone in improving functional MR in patients~     with LV dysfunction and functional MR.~   "
28208|NCT02687919|"~     This is a research study. The investigators are inviting participants to participate in this~     research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple~     Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of~     the following: liver disease, kidney disease, diabetes, active heart disease, heart block or~     arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet~     use, psychosis or other psychiatric disorder likely to impact ability to comply with study~     procedures, any change in prescription medication for a mental health problem such as~     depression or anxiety in the last three months.~      The purpose of this research study is to determine whether or not a modified Paleolithic~     diet results in any change in health in persons with RRMS compared to usual care. The~     investigators define usual care as the typical or usual physician recommendations for the~     treatment of RRMS.~      The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet,~     and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of~     wild plants and animals of ancestral humans during the Paleolithic era (a period of about~     2.5 million years duration that ended around 10,000 years ago with the development of~     agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables,~     fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined~     sugar, and processed oils.~      To the investigators' knowledge, most neurologists prescribe medications that may reduce or~     prevent future disability, but few prescribe dietary modifications unless needed for other~     concomitant disease.~   "
28209|NCT02687906|"~     A single dose infusion of Carbavance (meropenem-vaborbactam) is being tested for~     dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to~     less than 18 years of age with serious bacterial infections~   "
28210|NCT02687893|"~     Growing evidence provided by many observational studies has established a strong link~     between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep~     quality induce insulin resistance and decrease glucose tolerance in healthy individuals.~     However, the influence of poor sleep quality on glycemic control of patients with Type 1~     diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM~     has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia.~     Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies.~     Although severe hypoglycemia is associated with adverse events such as seizures and death,~     less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences,~     both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a~     stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis~     (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive~     cortisol secretion, which is known to cause sleep disturbance and could impair glucose~     homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA~     hyperactivity as well, which is also associated with impaired sleep quality by leading to~     sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep~     disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely~     affecting the sleep-wake cycle.~      The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.~   "
28211|NCT02687880|"~     Many chemotherapy and radiation-containing regimens for cancer or prior to bone marrow~     transplantation can cause sterility in children and young adults. In addition, some human~     disease conditions (e.g., Klinefelter's) are associated with infertility. Semen~     cryopreservation is available as a fertility-preserving option for post pubertal boys and~     adult men, but many do not take advantage of this option due in part to lack of information,~     illness, and/or time constraints relative to their treatment plan. Currently, no~     fertility-preserving options are available for prepubescent boys who are not yet producing~     sperm. The primary objective of the proposed study is to 1) Optimize techniques for~     cryopreserving testicular tissue, 2) Assess malignant contamination in testicular tissues~     and 3) develop methods to enrich spermatogonial stem cells and remove malignant~     contamination from testicular tissue. In addition, this study will process and cryopreserve~     tissue and/or cells for participating patients as a resource for future elective procedures~     to attempt fertility restoration.~   "
28212|NCT02687867|"~     To obtain a better understanding on the comparative effectiveness of dabigatran versus~     Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial~     fibrillation (NVAF) in a real-life setting.~   "
28213|NCT02687854|"~     To obtain a better understanding on the comparative effectiveness of apixaban versus VKA~     (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial~     fibrillation) in a real-life setting.~   "
28214|NCT02687841|"~     Hospital acquired acute kidney injury is an important negative outcome predictor for~     hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these~     uremic toxins are protein bound and may accumulated after renal impairment, owing to both~     impaired filtration, and inflammation. Recent animal studies have reported that accumulation~     of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial~     progenitor cells and in turn affect renal recovery. Elimination of these protein bound~     uremic toxins with an activated charcoal would help restore endothelial function. We will~     conduct a double blinded randomized placebo controlled trial, which aims to determine that~     if oral activated charcoal will retard progression of AKI. Also, a panel of markers for~     endothelial function will also be determined.~   "
28218|NCT02687789|"~     Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a~     disturbance in the vaginal microbiological milieu. Anaerobic bacteria, such as Gardnerella~     vaginalis and Atopobium vaginae overgrow the physiologic vaginal flora which is dominated by~     Lactobacilli. BV can arise and remit spontaneously but often presents as a recurrent~     disease.~      New findings indicate that the presence of an adherent bacterial biofilm on the vaginal~     mucosa seems to be the reason for the recurrence of BV as well as the overgrowth condition~     by anaerobic bacteria. Biofilms are defined as a structured consortium of bacteria embedded~     in a matrix of extracellular polymeric substances (EPS).~      The purpose of this study is to achieve substantial results with respect to tolerability and~     safety, and to gain further knowledge on the clinical efficacy of Vaginal suppository~     WO3191, the investigation will be performed in a parallel-design, double-blind, randomised,~     controlled manner.~   "
28219|NCT02687776|"~     Observational cohort study examining the perioperative course of copeptin in patients~     undergoing elevated-risk surgery.~   "
28220|NCT02687763|"~     A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and~     Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being~     considered and/or evaluated for any solid organ transplant (heart, liver or kidney)~   "
28221|NCT02687750|"~     Testing of a dual tuned proton/fluorine MRI radio frequency coil~      Images were collected from plastic fluorine phantoms taped to the upper thigh of health~     volunteers.~      This trial was performed as part of an application for a Health Canada Investigational~     Device Exemption (Protocol # 226949)~   "
28222|NCT02687737|"~     The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There~     are few therapeutic options offered to these individuals. One more recent therapeutic option~     is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain~     or increase expiratory force generating pressures, cough function, and swallowing in a~     number of disease populations. Recently, the investigators have noted improvements in oral~     transit time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that~     could potentially be attributed to improved base of tongue functioning and muscle~     activation.~      There has been one study that demonstrated that breathing training resulted in increased and~     prolonged submental (under the chin) muscle activation as evidenced by surface~     electromyography. However, no studies have investigated the activation of the tongue muscles~     during various swallowing and breathing exercises. A small needle electrode (fine wire EMG)~     is standard of care in diagnosing muscular diseases because it can determine amount of~     muscle recruitment for muscles throughout the body. This aim of this research study is to~     examine the effects of breathing exercises and swallowing exercises on tongue muscle~     activity in healthy adults.~   "
28223|NCT02687724|"~     GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A~     nationwide multi-centred randomised controlled trial (RCT) investigating the use of GLM dose~     adjustment in ulcerative colitis (UC). The primary objective is to ascertain if dose~     adjustment of GLM based on GLM drug levels and FCP levels results in higher response and~     remission rates than standard SmPC dosing.~   "
28224|NCT02687711|"~     Study is the first study after commercialization of brivaracetam. It is designed to collect~     real world information on the effectiveness of brivaracetam in patients with Partial Onset~     Seizure epislepsy who are treated in standard clinical practice.~   "
28225|NCT02687698|"~     Parkinson's disease concerns some defects in carbohydrates metabolism involved in the~     progress of the pathology. Ketogenic diet has been largely studied as treatment on~     drug-resistant epilepsy and other neurologic diseases, but there is little information on~     the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our~     study is thus to evaluate the effect of a lipid and protein controlled diet on resting~     energy expenditure, body composition and symptoms in patients with Parkinson's disease.~   "
28226|NCT02687685|"~     SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and~     maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period~     strategy that has proven to benefit the initiation and continuation of human lactation and~     decreased hospitalization during the first week of life. This study aims to determine the~     effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term~     newborns treated at Universidad de La Sabana Clinic, on the duration of exclusive human~     lactation.~      Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the~     duration of exclusive human lactation in full-term newborns treated at the Universidad de La~     Sabana Clinic?~      Methodology: A random blind clinical trial was performed in which full-term healthy newborns~     that are attended at the Universidad de La Sabana Clinic are included. The blind~     participants will be those persons measuring the results and analysing the data. The sample~     size is calculated for a type I error of 5%, a two tailed type II error of 20%, therefore~     estimating percentage losses of 30%; 150 infants were included per group. Randomization will~     be performed using permuted, size 6 blocks. Descriptive analysis will be conducted using~     central tendency and dispersion measurements. A bivariate analysis will be performed to~     determine which variables are associated with exclusive human lactation at 6 months. For~     continuous variables, the Student t- test will be used for independent samples or the~     Wilcoxon rank sum test, in case the assumptions of normality for the t-tests are not~     fulfilled. The assumption of normality will be evaluated with the Shapiro Wilk and~     Kolmogorov-Smirnov test. Categorical variables in contingency tables will be constructed,~     assessing independence between variables with the Chi-square test or Fisher's exact test~     when the assumption of the number of cases is not met by the cells in the contingency~     tables, times two. It will be calculated as a measurement of the effect of relative risk~     (RR) with confidence intervals; the adjusted measurements will be calculated using a~     multivaried regression Poisson model, variables with significant results will be used in the~     bivariate analysis and those with biological plausibility used for the adjustment. The~     analysis will be carried out for a two-tailed type I error level of 5%. The Stata 11 program~     will be used for the data analysis. An interim analysis will be performed upon submission of~     half of the expected events (106), setting limits for early termination of the trial~     according to the method proposed by Pampallona and Tsiatis (1994).~      Intervention: There will be 2 SSC randomization groups, early vs. immediate. After~     completing the neonatal adaptation process and according to the group assignment, it will~     proceed to leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT~     scale will be applied. Monitoring will initially be performed with a face valuation between~     3 and 10 days of life, then monthly telephone calls for 6 months to verify the status of~     human lactation.~      Results: To determine whether early versus immediate SSC has an impact on the duration of~     exclusive human lactation.~   "
28227|NCT02687672|"~     This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as~     sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in~     treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on~     the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells~     into the injured spinal cords of patients.~   "
28228|NCT02687659|"~     Physical inactivity is a major public health issue. Prescription of physical activity~     appears necessary in some situation with cardiovascular risk. It is important to both~     qualify and quantify daily physical activity.~      The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt)~     performance in 12 healthy subjects, wearing this system over the daytime during one week.~   "
28229|NCT02687646|"~     Sequential administration of MSCs obtained from adipose tissue is an effective and safe~     treatment for acute graft versus host disease refractory to first-line treatment.~     Furthermore the infusion of these cells produces a biological pattern in patients that~     relates to the clinical response.~   "
28230|NCT02687633|"~     The investigators are running an intervention study for young children with Tuberous~     Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that~     may improve social and communication skills in children with TSC. Eligible families will~     have a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also~     be available to attend the weekly intervention sessions at UCLA.~      The intervention will focus on teaching caregivers skills to improve the social and~     communication outcomes of their children. The content of the intervention will be~     individually tailored to the child's developmental level. The intervention involves~     pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by~     weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3~     parent-child dyad and the curriculum focuses on improving social-communication and play~     skills.~   "
28231|NCT02687620|"~     The purpose of this prospective cohort study is to evaluate the influence of serum drug~     levels and development of anti-drug antibodies on clinical response to anti-TNF agents in~     ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical~     and laboratory variables associated with the development of anti-TNF drug antibodies at~     baseline or disease course and to reveal the impact of anti-drug antibodies on long-term~     efficacy or safety in particular drug survival in AS patients treated in daily clinical~     practice.~   "
28233|NCT02687594|"~     An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide,~     sucrose, and starches. It was well tolerated in the clinical development program. The~     approved indication in the European Union (EU) is to control serums phosphorus (sP) levels~     in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal~     dialysis).~      It is of major interest to observe the drug in daily use outside of controlled trial~     settings. The Marketing Authorisation Holder wishes to obtain further systematic data within~     a non-interventional study to investigate short and long-term safety.~      Effectiveness and Treatment adherence during real-life use will be evaluated.~   "
28234|NCT02687581|"~     This study is designed to evaluate the effectiveness of a novel amblyopia treatment -~     Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.~      Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the~     amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching~     group or 2) 12-hour IO-therapy glasses group.~   "
28235|NCT02687568|"~     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for~     patients. Pain and vasovagal reactions are common. Therefore, the implementation is~     generally recommended under sedation and also carried out in practice here.~      The vital signs monitoring to avoid complications is dictated by current national~     guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure~     measurements. In patients with severe heart disease an ECG recording should be used~     additionally. Moreover, the guidelines require that the sedation is clinically monitored~     continuously to avoid an unwanted anesthetic stage. Such evaluation, however, is often~     difficult under clinical conditions and even counterproductive, since a constant response~     and tactile stimulation of the patient (to check clinically the depth level of sedation ),~     interrupts endoscopic complex intervention. However, clinical most relevant aspect is the~     avoidance of unrecognized transition of patients from the stage of deep sedation in an~     anesthetic stage.~      Current recommendations do not take into account new study results from a gender~     perspective, which showed that women and men need a different wake-up time using the EEG~     derivation means by using the Narcotrend after total intravenous anesthesia, which may be~     due to different total doses of sedatives needed. However, the research group has been~     demonstrated in a previous study that most likely caused by the use of EEG monitoring~     (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time~     by a lower dose of the administered sedative for a continuous sedation stage D0-D2~     endoscopic retrograde cholangiopancreatography-(ERCP).~      In the presented study the investigators evaluate the extent of gender differences in the~     wake-up time after sedation with propofol during colonoscopy when using EEG monitoring.~   "
28236|NCT02687555|"~     The purpose of this study is to determine whether a computerized training, Cognitive Bias~     Modification targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma~     in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition.~     Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional~     cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for~     Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of~     Bochum.~   "
28237|NCT02687542|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.~   "
28238|NCT02687529|"~     To compare the positivity rate of the investigational assay to the currently approved~     QuantiFERON-TB Gold In-Tube assay.~   "
28239|NCT02687516|"~     This study aims to evaluate the effectiveness of Family-based behavioral social facilitation~     therapy (FBSFT) in the treatment of severe obesity in children and adolescents compared to~     treatment as usual (TAU). The FBSFT condition includes 17 weekly family-based treatment~     sessions at the hospital obesity clinic followed by monthly follow-up sessions with their~     local nurse and follow-up sessions at the hospital every third month for 2 years. The~     treatment targets both child and parent life-style; eating habits, physical activity,~     sedentary activity and sleep habits. Behavior modification techniques are employed; such as~     self-monitoring, goal setting, reward systems, problem solving and stimulus control. In~     addition, FBSFT focuses on facilitating lifestyle change across different settings (family,~     friends, school and community) and harnessing social support for healthy habits, which is~     considered important for long-term weight control. The TAU condition involves an assessment~     day with the multidisciplinary team (pediatrician, dietician, physical therapist and~     psychologist) at the hospital obesity clinic. Further a session with the nurse at the~     hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up~     sessions with their local nurse and follow-up sessions at the hospital clinic every third~     month for one year.~      SAMPLE AND STUDY DESIGN. The sample will consist of children and adolescents (aged 8-16)~     referred to the Obesity Outpatient Clinic at Haukeland University Hospital. Criteria for~     admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related~     co-morbidity. Based on current clinic data, estimations suggest that about 60 families of~     children with severe obesity will be referred to the Obesity Outpatient Clinic every year~     and be offered treatment. Recruitment will start in February 2014 and will continue in 2015~     and 2016. After consenting to participation and completion of the initial assessments the~     families will be randomized to either FBSFT or treatment as usual (TAU). After one year the~     families randomized to TAU will be offered the FBSFT treatment. Measurement points for the~     most important outcome measures will be pre-treatment, post-treatment (at approximately 6~     months), at 12 months, 18 months and 24 months.~      OUTCOME VARIABLES. Anthropometrical measures: Height, weight and waist-circumference,~     DXA-scans and bio-impedance measurements for determining the distribution of fat and muscle~     tissue. Physiological measures: Blood samples will be drawn in the morning after an~     overnight fast. Including measurements of total-cholesterol, HDL, LDL, TG, ASAT, ALAT,~     gamma-GT, bilirubin, creatinin, HbA1c and fasting insulin, c-peptide and glucose, TSH, fT4,~     CRP. Cortisol measurements from saliva and urine. Measurement of bloodpressure. Food~     records: The parents will be instructed to help their children to keep a diary of food and~     beverage intake for five days. They will use an electronic kitchen scale to weigh the food.~     Physical activity: Physical activity and sleep will be measured by using accelerometers.~     Psychological measures: The Child Behavior Checklist (CBCL) is a 138-item rating scale~     assessing behavioral and emotional symptoms in children/youth. Children's Depression~     Inventory (CDI). CDI is a 27-item self-report test assessing symptoms of depression in~     children (7-17 years). Self-Perception Profile for Children (SPPC). SPPC is a self-report~     measure of self-perception in children aged 8 to 14 years. The Dutch Eating Behavior~     Questionnaire Child version (DEBQ) is a measure of disturbed eating patterns in children and~     youth. The Youth Eating Disorder Examination-Questionnaire (YEDE-Q) is a self-reported~     measure of eating patterns and eating disorder psychopathology. OTHER MEASUREMENTS INCLUDED.~     The Parenting Scale (PS) is a 30-item questionnaire designed to measure different parental~     disciplines with children/youth. The scores on three sub-scales are calculated - Laxness,~     Overreactivity and Verbosity. The Barriers to Treatment Participation Scale (BTPS). The~     44-item scale is developed and validated to address drop-out from treatment with out-patient~     psychological treatment of children and adolescents. Child and parent acceptability of the~     treatment will be measured by the FBSFT Acceptability Questionnaire.~      STUDY AIMS:~        1. To evaluate the effect of FBSFT compared to TAU for treatment of severe childhood and~          adolescent obesity in an ordinary health care setting on BMI, BMI SDS, body~          composition, cardio-metabolic health, eating habits, physical activity as well as~          psychological well-being.~        2. To identify predictors of treatment success and treatment drop-out with a focus on~          family variables and mental health.~        3. To evaluate treatment (FBSFT) implementation and treatment acceptability for children,~          parents and health care workers and experienced barriers to treatment, and how these~          factors influence children's and parents' treatment response.~   "
28240|NCT02687503|"~     Probiotics are microorganisms that are believed to provide health benefits when consumed.~     The term probiotic is currently used to name ingested microorganisms associated with~     beneficial effects to humans and animals. Probiotics are popularized in the lay literature~     for many different clinical problems. They have been studied in infants and children as a~     preventive or treatment for a variety of infections. Studies on the medical benefits of~     probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness~     has yet to be conclusively proven for most of the studies conducted thus far. The putative~     benefit of probiotics in the prevention of infection relates to potential benefits to the~     innate and adaptive immune systems of infants.~      The goals of this investigation are to study immune system cell function in children who are~     taking probiotics.~      To accomplish this goal, the investigators propose a pilot study for which blood samples~     will be obtained prior to and post probiotic use in children greater than or equal to 12~     months-36 months at the end of 3 months.~   "
28241|NCT02687490|"~     Abraxane in patients with visceral metastases dominant metastatic breast cancer~   "
28242|NCT02687477|"~     This project is focused on the treatment of severe obstructive sleep apnea with pulmonary~     artery denervation (PADN). Although it has now been proved that continuous positive airway~     pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand,~     there is evidence that 25 to 50% of patients can not tolerate CPAP.~      The investigators previously reported the safety and efficacy of pulmonary artery~     denervation (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation~     play an important role in the occurrence and development of OSA and cause cardiovascular~     events. It is worth evaluating the feasibility and tolerance of introducing PADN at the~     severe stage of obstructive sleep apnea. Therefore, the purpose of our study is to evaluate~     the safety and feasibility of PADN in the treatment of severe OSA.~   "
28243|NCT02687464|"~     Rationale and Aim: The standard treatment for acute appendicitis in children is~     appendectomy. An increasing body of evidence from the adult literature suggests that acute~     appendicitis may be treated effectively with antibiotics alone, avoiding the need for~     surgery. The aim of this study is to investigate the effectiveness of non-operative~     treatment of acute appendicitis in children.~      Study design: Pragmatic, parallel-group, unmasked, non-inferiority multicentre randomized~     controlled trial (RCT).~      Patient allocation: Children will be randomly allocated (age 5-16 years) with a diagnosis of~     acute appendicitis to either laparoscopic appendectomy or treatment with antibiotics.~     Randomization will be performed using stratification to ensure equal distribution between~     groups of presenting clinical and demographic features that may influence outcome including~     gender, duration of symptoms and center.~      Interventions: One group of children will undergo laparoscopic appendectomy that is the~     current standard treatment for children with acute appendicitis. The other group will be~     treated with intravenous antibiotics. A treatment pathway specifically designed for this~     study will be used.~      Primary Outcome: To be meaningful to parents of, and clinicians treating, children with~     acute appendicitis, the primary outcome is treatment failure defined as: (i) any additional~     intervention related to appendicitis requiring general anesthesia within 1 year of~     randomization (including recurrence of appendicitis after non-operative treatment, which we~     will treat with appendectomy) or (ii) negative appendectomy. Secondary outcomes are: (i)~     complications; (ii) time to discharge following randomization; (iii) number and duration of~     hospital admissions.~      Sample size and data analysis: The proposed RCT has a 20% non-inferiority margin to test the~     null hypothesis that treatment with antibiotics is inferior to appendectomy. Based on data~     from collaborating centers and a pilot study that we have performed, we expect recruitment~     of 978 children in total (90% power) over 19 months allowing for drop out. Follow-up will be~     for 12 months.~   "
28244|NCT02687451|"~     The purpose of the study is to evaluate the efficacy, tolerability, safety and~     pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe~     post-operative pain in pediatric subjects.~   "
28247|NCT02687412|"~     Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS~     is a multidisciplinary approach aiming to accelerate recovery, reduce complications,~     minimize hospital stay without an increased readmission rate and reduce healthcare costs,~     all without compromising patient safety. It has been used successfully in non-malignant~     gynecological surgery, but it has been proven to be especially effective in elective~     colorectal surgery. However, no consensus guideline has been developed for gynecological~     oncology surgery although surgeons have attempted to introduce slightly modified FTS~     programmes for patients undergoing such surgery. NO randomised controlled trials for now.~      The advantages of fast-track most likely extend to gynecology, although so far have scarcely~     been reported. There is a existing research showed FTS in gynecological oncology provide~     early hospital discharge after gynaecological surgery meanwhile with high levels of patient~     satisfaction.~      The aim of this study is to identify patients following a FTS program who have been~     discharged earlier than anticipated after major gynaecological/gynaecological oncologic~     surgery and analyze the complication after surgery.~   "
28248|NCT02687399|"~     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the~     total blood loss associated with the total knee arthroplasty.~   "
28249|NCT02687386|"~     This is an open-label, sequential dose exploration study of single agent EEDVSMit~     administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance~     dosing, in children with recurrent/refractory solid or CNS tumours.~   "
28250|NCT02687373|"~     This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy~     children aged 5 months through 9 years of age living within approximately 10 km of the study~     clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility~     in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5~     months - 12 months inclusive will be eligible for Part 2.~   "
28251|NCT02687360|"~     Neuropathic pain is difficult to treat and is associated with the development of mood and~     substance use disorders. Most medications are only moderately effective, and deep brain~     stimulation is being used to treat sever chronic neuropathic pain. However, this requires~     brain surgery. The goal is to investigate the use of transcranial magnetic stimulation (TMS)~     directed at the medial prefrontal cortex and anterior cingulate for this disorder. These~     brain regions are in the prefrontal cortex, and research from deep brain stimulation studies~     indicated that stimulating this region may help treat pain. This is a pilot study to~     investigate the use of transcranial magnetic stimulation (TMS) directed at the regions in~     the prefrontal cortex using the H7 coil, which was developed to reach these deeper brain~     structures. While previous studies have investigated rTMS for pain, none, have used this~     coil to target these brain regions. This study will investigate active vs sham treatment in~     chronic pain participants.~   "
28252|NCT02687347|"~     The research hypothesis of this study is: In patients with moderate to severe cancer related~     pain, the addition of low dose methadone to an existing opioid significantly reduces pain~     severity compared to low doses morphine.~   "
28253|NCT02687334|"~     The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2)~     during anesthesia induction.~   "
28254|NCT02687321|"~     To evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial~     ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of~     the first line treatment. To evaluate the lead-time of the rise of marker levels before~     epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate~     the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian,~     Fallopian tube and primary peritoneal cancer.~   "
28255|NCT02687308|"~     Prospective randomized study performing open anterograde anatomical radical retropubic~     prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by~     the Pasadena consensus for the procedure assisted by robot, compared with the anatomical~     radical prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown~     benefits in the minimally invasive surgical techniques approaches, laparoscopic radical~     prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These~     minimally invasive techniques were associated with advantages in complications, like~     intraoperative bleeding, transfusion rates and in earlier recovery of important~     genitourinary functions such as urinary continence and penile erection. But still has not~     been demonstrated conclusively advantages as oncological control and it is believed that~     there are about 200 to 250 cases of learning curve so that the rates of complications and~     positive surgical margins become stable and similar to the open radical prostatectomy. These~     facts associated with the high cost of robotic technology still have limited the~     generalization of this approach in many developing countries such as Brazil. While the~     majority of studies made by comparing the radical prostatectomy (RP), robot X laparoscopic X~     open, show a slight advantage in the first two, there is a significant bias in these~     studies, which is that the surgical technique used in each procedure differs significantly~     from minimally invasive and open surgical techniques. The evolution of minimally invasive~     radical prostatectomy was based on an entirely different anatomical benchmark of that~     described by Patrick Walsh. While robotics and laparoscopic techniques dissect the prostate,~     bladder neck and the neurovascular bundle in an antegrade way, from bladder neck to the~     apex, the Walsh RRP technique is completely different in several ways, the dissection is~     made from prostatic apex to the bladder neck, so the retrograde direction, the posterior~     layer of Denonvilliers' fascia, is always included with the specimen, and urethrovesical~     anastomosis, usually performed with multifilament interrupted suture, only for indicating~     the major differences. The RRP2A will be performed by incision (open surgery) and will be~     compared with the anatomical radical prostatectomy technique described by Patrick Walsh RRP,~     and performed by the same surgeons.~   "
28256|NCT02687295|"~     Objective:~      The purpose of this study was to investigate the possible effects of green-plant thylakoid~     supplementation to a restricted diet intervention study in overweight to obese men.~      Methods:~      Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month,~     followed by one month of stabilization. Then they were divided in two treatment arms of one~     month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body~     measurements and blood samples were taken throughout the study.~   "
28257|NCT02687282|"~     The incidence of failed intubation in obstetric population is about eight times greater than~     in the non-obstetric population, as pregnancy is related to significant physiologic changes.~      The Mallampati classification is an estimate of the tongue size relative to the oral cavity.~     It is a method widely used to predict difficult airway management, as it is easy to perform~     and to reproduce. In obstetric population, Mallampati classed 3 and 4 increase likelihood of~     difficult intubation by 7.6 and 11.3 times, respectively.~      There are studies demonstrating the increase of Mallampati score during the course of~     pregnancy and vaginal delivery; the underlying causes being airway edema, intravenous fluid~     administration, or antidiuretic effects of oxytocin. Therefore, the aim of our study is to~     evaluate the modified mallampatti score at several point of time before and after cesarean~     delivery.~      Study Type: Observational Cross-sectional study~   "
28269|NCT02687126|"~     The purpose of the study is to evaluate the success rate using ultrasound as guidance during~     central venous cannulation in pediatric cardiac surgical patients.~   "
28258|NCT02687269|"~     Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the~     disease severity and operative procedural complexity have increased and morbidity rate is~     still high. Ischemia-reperfusion (I/R) injury, redefined in cardiac surgery~     post-cardioplegic injury (2) as a whole of ischemia-reperfusion, cardiopulmonary bypass~     and surgical trauma, has been recognized as a significant contributor to mortality and~     morbidity. I/R injury is classified as reversible or irreversible. Reversible injury~     includes arrhythmias, edema, vascular dysfunction and contractile stunning expressed as low~     output syndrome without cell death and without apparent signs of infarction or other serum~     injury markers. Irreversible reperfusion injury includes apoptosis and necrosis. I/R injury~     is a complex process associated with increase of radical, oxidant and cytokines production,~     complement and neutrophil activation and endothelial activation leading to microvascular~     dysfunction and deterioration of coronary flow reserve. In the hypoxic heart increase~     anaerobic lactate production, K+ efflux and membrane depolarization. The intracellular Na+~     concentration rises as a consequence of slow Na+ channels inactivation and the induction of~     voltage-gated Na+ channel late current component (late INA). Intracellular Na++ accumulation~     enhanced activity of reversed-mode Na+-Ca++ exchanger causing intracellular Ca++ overload~     and ventricular dysfunction. Therefore inhibition of late INA has been shown to be~     cardioprotective. Ranolazine, an FDA-approval antianginal and anti-ischemic agent, high~     selective blocker of late INA, inhibits the late sodium current in myocardial ischemia,~     decreases Na+ and Ca2+ overload and improves left ventricular function in experimental~     animal models. For this reason it was also adjuncted to cardioplegia improving diastolic~     function in isolate Langerdoff-perfused rat hearts. The authors test the hypothesis that~     ranolazine improve myocardical protection in patients undergoing coronary artery surgery~     with cardiopulmonary by-pass (CPB).~   "
28259|NCT02687256|"~     This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong~     insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.~   "
28260|NCT02687243|"~     Preoperative anxiety (PA) affects up to 5 million children in North America each year and is~     associated with adverse medical, psychological, and behavioral effects. Children who are~     highly anxious often require more medications during surgical procedures and take longer to~     recover. While many attempts have been made to reduce PA in children, existing interventions~     are limited by their expense and time intensive nature. Thus, the current lack of effective~     and efficient methods of reducing anxiety in children before and after surgery has prompted~     us to develop and propose to test a new intervention. The investigators have developed a~     novel,interactive tablet based Virtual Reality program, StoryTelling Medicine (STM), to help~     reduce anxiety in children undergoing elective surgery, and its associated negative effects.~      STM is an age appropriate, customizable program to prepare children for complex surgical~     procedures by guiding them through the hospital settings. The investigators will examine if~     STM is effective in reducing PA and its adverse effects in children undergoing surgery. If~     effective, STM has the potential to improve children's and families' surgical experiences,~     and reduce health problems in the hospital setting and beyond.~   "
28261|NCT02687230|"~     Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing~     PET scans. The study is designed to determine the best time and dose of these agents that~     result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for~     imaging and a clinical assessment. The last study visit is on day 28.~   "
28262|NCT02687217|"~     The study evaluates the role of supplemental hyper-oxygenation given perioperatively on~     wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half~     of them received no oxygen during the surgical procedure.~   "
28263|NCT02687204|"~     Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary~     embolus) are feared complications of reconstructive surgery. One in ten patients with~     symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous~     thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor~     quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have~     substantial downstream ramifications, and the US Surgeon General and the American Society of~     Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in~     surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries~     or defects after cancer excision, often involves borrowing tissue from adjacent or distant~     areas on the body; reconstructive surgery patients can routinely have surgical injury~     involving 20% or more of their total body surface area. Injury and resultant inflammation~     are known to increase metabolism of certain drugs, including those used to prevent VTE after~     surgery.~      Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation.~     Previous research has shown that reconstructive surgery patients who are given enoxaparin~     after surgery are less likely to develop VTE. However, despite receiving of a standard dose~     of enoxaparin, many patients still develop this life-threatening complication. The~     investigators believe that patients metabolize enoxaparin differently based on the degree of~     surgical injury created during reconstruction, and seek to critically examine enoxaparin~     metabolism in reconstructive surgery patients. The proposed research will evaluate how~     enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive~     surgeries; the investigators will also examine whether the extent of surgical injury alters~     metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa)~     levels. If subtherapeutic aFXa levels are observed, the study will also design, implement~     and test a clinical enoxaparin dose-adjustment protocol to achieve appropriate~     post-operative aFXa levels. Further research based on these data will examine reduction in~     VTE risk when aFXa-driven enoxaparin dosing is used.~   "
28264|NCT02687191|"~     This study employs a modified continual reassessment method (mCRM) design to estimate the~     maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based~     on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes~     Bayesian methodology to continuously learn the dose-toxicity relationship, which is~     characterized by a parametric model.~      Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in~     cohorts of 3. The total length of time planned for study participation is approximately 3~     months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital~     confinement period and follow-up visits through Day 91.~      Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according~     to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events~     (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The~     determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days~     post-dose (Day 8).~   "
28265|NCT02687178|"~     To evaluate the efficacy on blood pressure reduction, safety and tolerability of two~     different dosages of canrenone as add-on therapy in patients already treated with~     Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs)~     and diuretics at the maximum dosage.~   "
28266|NCT02687165|"~     This study will investigate (a) neural and immune mechanisms underlying chronic pain in PTLS~     by comparing a group of PTLS patients and healthy participants on brain imaging, sensory,~     and immune markers; and (b) assess change in pain, brain imaging (fMRI and MRS), sensory,~     and immune markers in response to a combination of SNRI and glutamatergic treatment for~     chronic pain in PTLS (Milnacipran and D-cycloserine).~   "
28267|NCT02687152|"~     The present project is designed to test the hypothesis that arginase contributes to~     microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular~     complications.~   "
28268|NCT02687139|"~     In this study the investigators aim to evaluate diagnostic utility of 18F-DCFPyL positron~     PET/CT in patients with renal cell carcinoma.~   "
28271|NCT02687100|"~     The aim of the study is to test the effectiveness of a solutions of beclomethasone~     repeatedly instilled through the supraglottic line of the endotracheal tube on~     post-extubation airway disturbances related to tracheal intubation. The primary endpoint~     will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after~     extubation. Secondary endpoints will regard the effects on hoarseness and cough.~   "
28272|NCT02687087|"~     The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease~     dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck~     cancer patients.~      A parallel group double blind study design has been selected. The primary outcome is change~     in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome~     will be compared between Visco-ease and the placebo treatment.~   "
28273|NCT02687074|"~     Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation~     could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital~     stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space,~     increasing EELV and improving comfort, and it has been used to treat respiratory failure~     patients. In recent study, HFNC could improve mortality of respiratory failure patients with~     P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study~     to evaluate the effects of HFNC on the patients with respiratory failure.~   "
28274|NCT02687061|"~     The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis~     C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology~     laboratories will be explored for registered cases of cHB and cHC. Subsequently the~     investigators will compare the registered cases with the list of known cHB and cHC patients~     in hospital care. Patients lost to follow up will be informed and approached via either the~     Public Health Service (PHS) or their primary care physician. Identified patients will be~     invited for re-evaluation at the regional hepatitis centre (The North Western Hospital,~     formerly Medical Centre Alkmaar) to assess the current status of their chronic disease.~     Evaluation will be performed in accordance with (inter-)national guidelines, no extra~     interventions will be performed.~      After completion of re-evaluation, a final report will be made and send to both patient and~     primary care physician with recommendations for further follow-up.~   "
28275|NCT02687048|"~     Falls have significant consequences for older adults, including fracture, disability, and~     death (1). Risk factors for falls include both impaired physical and cognitive function (1).~     Thus, older adults with chronic stroke are at significant risk for falls (2).~      Exercise is an evidence-based approach for reducing falls risk, even among those who are~     living with stroke-related impairments (3,4). More recently, mindfulness based meditation is~     gaining recognition for its positive impact on both physical and cognitive health (6,7).~     Thus, the investigators hypothesize that combining exercise with mindful meditation may be~     greater impact on falls risk reduction as compared with exercise alone. To begin exploring~     our hypothesis, we will conduct a 12-week proof-of-concept study among 20 older adults with~     chronic stroke (i.e., suffered their first clinical stroke > or = 12 months prior to study~     entry). Participants will be randomly allocated to either: 1) exercise; or 2) exercise +~     mindfulness based meditation. Outcomes will include measures of mobility, balance, and~     cognitive function.~        1. Rubenstein, L.. Falls in older people: epidemiology, risk factors, and strategies for~          prevention. Age and Ageing 2006; 35-S2: ii37-ii41. doi:10.1093/ageing/afl084~        2. Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86~          (1):30-38~        3. Thomas S, et al.Does the 'Otago Exercise Programme' Reduce Mortality and Falls in Older~          Adults?: A Systematic Review and Meta-analysis. Age Ageing. 2010; 39(6): 681-687.~        4. Verheyden G, et al. Interventions for preventing falls in people after stroke. The~          Cochrane database of systematic reviews, 2013(5).~        5. Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical~          Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143.~        6. Grossman P, et al. Mindfulness-based stress reduction and health benefits. A~          meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.~   "
28276|NCT02687035|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards~     Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use~     in patients with symptomatic, calcific, severe aortic stenosis.~   "
28277|NCT02687022|"~     Wavefront scans are a common form of diagnostic test applied in preparing patients for laser~     eye surgery. An optical map of the eye is created by wavefront scanning, and information~     from these maps is used to program lasers used to correct focusing errors in the eye. Here~     the investigators are comparing how repeatable measurements are with a new wavefront scanner~     and one that is already in widespread use.~   "
28278|NCT02687009|"~     This study evaluates the safety of Niclosamide in patients with colon cancer that are~     undergoing primary resection of their tumor. This is a phase I study with three dosage~     levels to determine the maximum tolerated dose (MTD).~   "
28279|NCT02686996|"~     The aim of this study is to determine whether carnosine supplementation in overweight/obese~     individuals can improve insulin secretion and/or insulin resistance by decreasing sub~     clinical inflammation.~      The investigators hypothesise that carnosine supplementation will reduce type 2 diabetes and~     cardiovascular risk factors by lowering chronic low-grade inflammation (CLI), oxidative~     stress, advanced glycation end products (AGEs), and advanced lipoxidation end products~     (ALEs).~      Aim :To determine the capacity of carnosine supplementation to decrease major risk factors~     for type 2 diabetes and cardiovascular disease and identify metabolic pathways involved,~     specifically by:~        1. Reducing diabetes risk (insulin sensitivity; secretory function and glucose tolerance)~        2. Improving cardiovascular risk factors (lipids; arterial (aortic) stiffness; central~          blood pressure (cBP); endothelial function).~        3. Decreasing the CLI, oxidative stress, AGEs, and ALEs, and increase detoxification of~          reactive carbonyl species (RCSs).~   "
28280|NCT02686983|"~     Infiltration of the greater occipital nerve (GON) with local anaesthetics and~     corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful~     in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to~     assess efficacy and safety of sub-occipital steroid injections with local anesthetic in~     patients with chronic migraine.~   "
28281|NCT02686970|"~     The aim of this study is to adapt and validate to the Spanish the European Quality~     Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically~     ill and dying patients in the ICU.~   "
28344|NCT02686138|"~     This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will~     evaluate the safety and efficacy of one dose of Tenapanor in subjects with~     constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III~     criteria and who have active disease as determined after a two-week screening period.~     Subjects who qualify and are randomized into the study will either receive 50mg BID of~     Tenapanor (1:1) for a 26 week treatment period.~   "
28282|NCT02686957|"~     Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects~     women in low income countries. Despite the strengthening of research on fistula, there is~     little data on the follow-up after fistula repair.~      The objective of this study is to analyse the factors associated with the recurrence of~     fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target~     women who got a closed fistula at discharge after repair in 2012/2015 at three fistula~     repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral~     Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry).~      The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest~     will include patient characteristics, fistula characteristics, the context of repair and the~     context of reintegration.~      Participants giving an informed consent after a home visit by the Fistula Counsellors who~     managed women during surgery will be interview at enrolment and every six month from~     inclusion. The study duration is estimated at 48 months (January 2012 to March 2016)~     including the retrospective part.~      A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2%~     margin of error (width of confidence interval is 4%) and 95% confidence interval and is~     sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and~     10% precision.~      The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier~     methods and the risk factor analysis will be performed using adjusted cox regression.~      For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions~     of pregnancy outcomes between potential predictors and logistic regression models will be~     used and associations will be reported as risk ratios with 95% confidence intervals.~      Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA)~     with a level of significance set at P<0.05.~   "
28283|NCT02686944|"~     The study is a prospective single armed, open label phase I study. Patients with advanced or~     metastatic GIST and tumor progression despite ongoing treatment with second-line Sunitinib~     treatment, and with at least one measureable tumor lesion, will be eligible for the study. A~     maximum of 12 patients will be included in this study. The patients will continue with~     Sunitinib treatment until the 3 months follow up visit. If further tumor progression~     Sunitinib will be withdrawn but if stable disease or objective response the patient will~     continue with Sunitinib until progress. The investigational product Intuvax will be injected~     into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the~     first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only).~     Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT~     technique for correct administration.~   "
28284|NCT02686931|"~     Children with developmental disabilities and children's rehabilitation common case~     investigation: Long-term follow-up study.~   "
28285|NCT02686918|"~     The main of this study is to assess the feasibility of a patients follow-up visit receiving~     trastuzumab subcutaneous by Advanced Practice Nurse.~   "
28286|NCT02686905|"~     The objectives in this study are to provide information on the efficacy of transdermal~     supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric~     patients, and to determine short-term body composition, HbA1c and fasting plasma glucose~     outcomes for patients after bariatric surgery.~   "
28287|NCT02686892|"~     This is a prospective, observational, multicenter, population-based incidence cohort study~     which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1~     year in Spain.~      In addition, each incident case that gave his/her informed consent, will be followed up for~     12 months to determine changes in phenotype or disease location, the need for~     immunosuppressive and biologic treatments, and the need for hospital admissions and surgery~     during the first year after diagnosis.~   "
28288|NCT02686879|"~     Hyperopia, also known as farsightedness, is a common type of refractive error where distant~     objects may be seen more clearly than objects that are near.~      Hyperopia is a known risk factor for amblyopia, (lazy eye), which may occur as a result of a~     squint (turn), or due to different levels of hyperopia between each eye (anisohyperopia).~      Hyperopia and anisohyperopia often persist into adulthood resulting in impairment to~     binocular vision. Current management involves prescribing spectacles or contact lenses to~     correct the hyperopia in each eye, usually as a lifelong intervention.~      In recent years there has been a great deal of interest in delaying progression of myopia~     (short-sightedness) by slowing down the growth of the eye using a particular type of contact~     lens termed a centre-distance multifocal design. There have been some encouraging results in~     this area to date.~      The proposed study here would explore the use of centre-near multifocal design contact~     lenses to encourage growth of the eye, thereby reducing hyperopia. There are three elements~     to the programme of research:~        1. The natural progression of axial growth and refractive error will be measured in~          hyperopic and anisohyperopic subjects aged between 5 and 19. In other words, the~          natural growth of the eye will be followed without any intervention~        2. As a paired eye control study anisohyperopes aged between 8 and 15 will be fitted with~          a centre-near multifocal design contact lens in their more hyperopic eye and a single~          vision contact lens in the fellow eye, if required. The progression of axial growth and~          refractive error will be measured and compared in each eye~        3. Subjects' aged between 8 and 15 with similar levels of hyperopia in each eye will be~          fitted with centre-near multifocal design contact lenses in each eye. The progression~          of axial growth and refractive error will be measured and compared to subjects in the~          natural progression study~   "
28289|NCT02686866|"~     Feeding optimization and nutritional assessment in patients with severe heart failure are~     challenging. The prevalence of cardiac cachexia may be underestimated by simple measurements~     of body weight and body mass index because many patients show relative reductions in muscle~     mass despite being of normal overall weight. Body composition measurement can be essential~     in chronic heart failure (CHF) patients to estimate sarcopenia. Chronic heart failure~     patients with cardiac cachexia have a mortality two to three times higher than noncachectic~     patients. Bedside body composition measurements can reveal developing cardiac cachexia hence~     can be useful in prevention.~   "
28290|NCT02686853|"~     The main purpose of this study is to observe the clinical effect of intrathecal~     administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired~     Immune Deficiency Syndrome (AIDS).~   "
28291|NCT02686840|"~     The aim of this work is to compare the effectiveness of vaginal versus sub-lingual~     misoprostol for medical treatment of first trimester missed miscarriage.~   "
28292|NCT02686827|"~     Low Vitamin D3 (VD3) levels have been reported to be associated with the risk of allergic~     diseases like asthma. VD3 has been demonstrated in vitro, ex vivo and in animal models to~     program the immune system towards anti-inflammatory immune responses. VD3 co-administered~     with allergen may be a promising adjuvant to improve the onset and efficacy of allergen~     immunotherapy (AIT). A clinical trial will be performed to compare the immune effects, the~     tolerability and safety of multiple doses of aVD3 analogue (registered for the intravenous~     route) administered by the subcutaneous (s.c.) route in subjects with allergic rhinitis and~     healthy controls.~      The overall aim is to provide additional (in vivo) support for the use of VD3 as an adjuvant~     in allergen-specific immunotherapy, on top of the existing pre-clinical evidence~     demonstrating that antigen-presenting cells educate the adaptive immune system towards an~     anti-inflammatory response when allergen is seen in the presence of VD3.~   "
28293|NCT02686814|"~     The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215~     aortic valve bioprosthesis.~   "
28294|NCT02686801|"~     This study evaluates the perinatal factors influencing body composition at discharge in very~     preterm infants and the relationship between fat free mass and further neurocognitive~     development.~   "
28295|NCT02686788|"~     The purpose of this study is to assess the impact of TMP001 in the treatment of patients~     with relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of~     contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during~     treatment with TMP001 is compared to the average total number of CELs on brain MRI scans at~     week -4 and baseline in these patients .~      Based on promising preclinical results, the investigators assume a comparable effect of~     TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory~     substances in recent clinical studies.~   "
28296|NCT02686775|"~     The randomized trial evaluates whether assigning a patient coach to vulnerable lung cancer~     patients will empower these patients to participate in the treatment decision process, help~     patients navigate the health care system while undergoing treatment and adhere to cancer~     treatment and to recommendations for supportive care. Half of the participants will receive~     standard care and be offered a patient coach while the other half will receive standard~     care.~   "
28297|NCT02686762|"~     This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects~     with a diagnosis of definite NASH with fibrosis (excluding cirrhosis) as determined by the~     central histopathologist. Upon successful screening, subjects will be randomized to receive~     either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.~   "
28298|NCT02686749|"~     This study is a multi-center, randomized, unblinded, clinical trial. The objective is to~     determine if catheter-based atrial fibrillation (AF) ablation is superior to medical~     treatment in patients with impaired left ventricular (LV) function who have been diagnosed~     with symptomatic AF within the past 6 months.~   "
28299|NCT02686736|"~     The objective of this study is to design and evaluate an internet-based educational strategy~     to prevent sexual risk behaviors in Mexican adolescents. Methods: A field trial with one~     intervention and one comparison group, with ex-ante and ex-post measurements will be~     conducted in 2 public secondary schools. Adolescents between 14 and 15 years of age will~     participate. The intervention will be conducted in one school and the other school will~     serve as a comparison group, where investigators will observe the usual sexual education~     that the school provides. The intervention will be delivered through an internet web page;~     it includes four educational sessions that will be provided during a four-week period. The~     follow up will last three-months. The information on the study variables will be obtained~     through an internet-based self-applied questionnaire and collected on three occasions: when~     the adolescents enters to the study (baseline), once intervention is completed (at one~     month) and after three months of follow-up (at fourth month).~   "
28300|NCT02686723|"~     Comparison of two groups of subjets (ACL injury who return to sport) and control group~     non-injured about clinical and biomechanical data :~        -  clinical test~        -  functional test~        -  motion analysis of 2 sport exercises~        -  tibial translation~        -  isokinetic evaluation~   "
28301|NCT02686710|"~     Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving~     either volatile or intravenous anesthesia~   "
28302|NCT02686697|"~     This is a double-blind placebo-controlled trial to evaluate the effects of the combination~     of a cognition enhancing drug, i.e carnosine, with cognitive training in patients with~     schizophrenia. All participants will receive the same cognitive training sessions and will~     be randomised to either carnosine or placebo for the duration of the combined treatment~     period (2 weeks). Before combined training and carnosine/placebo, there is a two-week~     carnosine/placebo only phase to examine the effects of carnosine alone on functioning~     without training.~   "
28303|NCT02686684|"~     The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter~     (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in~     patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to~     investigate the effect of dimethyl fumarate on evolution of microstructural changes in~     normal appearing white matter (NAWM), as measured by DTI.~   "
28304|NCT02686671|"~     Shoulder pain is very common. People receive injections in their shoulder for their painful~     shoulder. However, investigators do not know which patient with shoulder pain responds best~     to an injection in the shoulder.~      Investigators plan to use a Pull Test where the researcher will pull on the arm and resist~     shoulder movement to investigate if it helps to determine which patients have better pain~     relief with the shoulder injection.~      The study will take place in Anchorage, Alaska. There will be two phases in the study. For~     each phase, the subjects will complete some questionnaires. Phase I Reliability Testing~     will test how consistent two licensed physical therapists are giving shoulder examination~     tests and the Pull Test. Phase II Pull Test will comprise shoulder examination findings,~     including the Pull Test, done before and after one shoulder injection performed as normal~     standard of care by a licensed physician.~      For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from~     Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain~     scheduled to have a shoulder injection will be asked by an investigator if they wish to~     participate in the study until a number of 30 subjects qualify for the study. Phase II of~     the study will include shoulder tests before and about 20 minutes after the injection and a~     4- to 7-day, as well as a 6-week, phone follow-up.~      Statistics will be used to analyze the data.~   "
28305|NCT02686658|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreous~     administration of Zimura® when administered in subjects with geographic atrophy (GA)~     secondary to dry age-related macular degeneration (AMD).~   "
28306|NCT02686645|"~     Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of~     fecal microbiota therapy (FMT) in the investigators population.~   "
28307|NCT02686632|"~     Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal~     mucosa. It is the most prevalent oral disease and the main indicator of poor oral health~     among denture wearers, affecting one-third of all complete denture wearers.~      The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria~     and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures.~     However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal~     therapy is common.~      The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing~     in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of~     change in CFU count and clinical inflammation will be carried out at baseline, 3 months and~     6 months.~   "
28308|NCT02686619|"~     This multicentre, prospective, randomized, open-label study will compare the safety and~     efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation~     of cyclosporine, with those of mycophenolate mofetil and long term continuation of~     cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction~     treatment and followed by 8 month treatment with corticosteroids. The anticipated time on~     study treatment is 12 months. Participants who will complete the initial 12-month study and~     who will provide written informed consent will be eligible to participate in a 60-month~     follow-up phase.~   "
28309|NCT02686606|"~     Patients with short bowel intestinal failure are recommended to aim for a diet high in~     energy and protein. Some patients have difficulties in achieving recommended intakes and~     additional nutrition may be provided by oral nutritional supplements. There is very little~     research completed on which is the best oral nutritional supplement for patients. The aim of~     the study is to see the effect different oral nutritional supplements have on your stoma or~     fistula output and levels of hydration.~   "
28310|NCT02686593|"~     The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML~     when used as first salvage for patients to relapse or fail after standard treatment with~     daunorubicin/cytarabine induction.~   "
28311|NCT02686580|"~     This study is designed to assess the effectiveness of porcine cross-linked collagen paste~     for the treatment of patients with ano-rectal abscess with underlying cryptoglandular~     fistula in ano.~   "
28312|NCT02686567|"~     The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium & low~     rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for~     deduce the rate. There were several studies, but most of them were not randomized controlled~     trial (RCT) studies. There was only one RCT study with enough samples, but it was designed~     for open anterior resection, and the patients underwent diverting stoma were excluded, so~     there was the selection bias. LAR now is thought to been with the same effect, and it is~     safe and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic~     leakage after LAR for medium & low rectal cancer is needed.~   "
28313|NCT02686554|"~     At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear~     to what extent the disease will devastate cognitive abilities within the next years. This is~     not only unsatisfying for the patient and the attending physician but also a major problem~     in the context of clinical trials that aim to establish new therapeutic agents. In clinical~     trials it is critically important to foresee as precisely as possible the course of the~     disease. The overall aim of the subproject is to identify a panel of CSF biomarkers to~     further improve specificity of diagnosis (disease markers), to measure disease activity~     and to predict AD progression (stage and progression markers).~   "
28314|NCT02686541|"~     The aim of this study is to study the effects of athrectomy followed by percutaneous~     transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de~     novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic~     peripheral vascular disease in an Asian population. The intention is to study the effects of~     debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in~     improved patency rates The study will prospectively recruit 8 cases treated with athrectomy~     followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in~     reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled~     trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB~     technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which~     is currently the most commonly used modality to treat femoral-popliteal lesions. There are~     no studies combining the effect of rotational athrectomy and DEBs.~   "
28315|NCT02686528|"~     The purpose of this study is to determine if hip precautions, which are instructions that~     limit functional use of a hip replacement after surgery, affect the rate of dislocation in~     the first six weeks after primary total hip replacement surgery. The impact of hip~     precautions on a patient's return to activities of daily living and overall patient~     satisfaction will also be investigated. The overall cost effectiveness of hip precautions~     will be determined.~   "
28316|NCT02686515|"~     The objective of this study is to investigate the effect of dual-task training at~     impairment, disability, and participation levels for stroke survivors and investigate~     possible factors affecting cognitive-motor interference (CMI) under dual-task conditions.~     Specifically, we will compare the immediate and retention effects of dual-task balance~     training and single-task balance training on CMI, balance confidence, fall rate, functional~     performance, and quality of life in individuals with stroke (Aim 1). The second aim of this~     study is to explore how lateralization, stroke chronicity, task type, and task difficulty~     may influence patterns of CMI (Aim 2). The third aim of this study is to investigate whether~     dual-task balance assessments are more sensitive than single-balance assessment in~     distinguishing stroke fallers from stroke non-fallers (Aim 3).~   "
28317|NCT02686502|"~     This study evaluates the effect and usability of mobile and cloud technology -based~     intervention on lifestyle modification in 18-40 year obese and overweight subjects.~      The study has a dose-response design with three randomized subjects groups from Mode 1 to~     Mode 3 with increasing intensity of intervention (guidance, exercise program, diet,~     support). The special focus of this study is on motivation and use of music and mobile~     health devices as motivational tools to support individualized exercise training, healthy~     diet and overall healthy life style.~   "
28318|NCT02686489|"~     The goal of the study is to compare the safety and efficacy of molecular water and bland~     aerosol therapy (particulate water) in providing adequate humidity to the inspired gas of~     spontaneously breathing tracheostomy patients.~   "
28319|NCT02686476|"~     Fatty liver disease is an increasingly recognized health problem in patients with type 2~     diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new~     class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of~     SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active,~     selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard~     care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to~     evaluate the effect of Empagliflozin on the liver fat content.~   "
28320|NCT02686463|"~     This trial is designed to compare diagnostic and therapeutic effects of laparoscopy vs.~     laparotomy on early malignant ovarian cancer, and to evaluate the efficacy and safety of~     laparoscopy in early malignant ovarian cancer.~   "
28321|NCT02686437|"~     The purpose of this study is to determine the effectiveness of standard tension of~     Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain,~     disability, and recovery speed during an in-office rehabilitative program. A convenience~     sample size of 38 new patients with current shoulder pain will be recruited for this study.~     The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder~     Score (PENN). After completing the initial paperwork, patients will be randomized into two~     groups, control (0% tension) and intervention(increasing tension). At the beginning of each~     week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4~     weeks patients will complete the PENN.~   "
28322|NCT02686424|"~     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite~     advances in therapeutic intervention, the mortality from this disease remains high. As a~     result, most patients are now offered varying combinations of surgery, chemotherapy, and~     radiation therapy in order to derive benefits from a multidisciplinary approach.~     Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary.~     Thus new therapeutic strategy is required for the treatment of gastric cancer.~      In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs)~     directed against an antigen presented on tumor cells was published. They can kill many~     invasive cells by recognizing the tumor specific antigens on the major histocompatibility~     complex (MHC) molecules. It is now generally agreed that although tumors express tumor~     antigens, they usually lack immunogenicity because of their inability to activate the immune~     response. The current view is that tumor cells are antigenic, but not immunogenic. If we can~     artificially activate the immune system against the tumor, it may be possible to eradicate~     the tumor. This approach is the basis of cancer immunotherapy.~      Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A,~     gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific~     antigen (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based~     therapies targeting these tumor antigens are in phase III trials assessing whether~     immunizing against these antigens affects overall survival. In gastric cancer, some tumor~     antigens such as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in~     substantial proportion of cases. They have the potential to be the targeting molecules for~     immunotherapy in the future. In this study, we aim to explore the expression levels of the~     four tumor markers (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients~     and to examine the correlations of the expression levels of the four markers to~     clinic-patholoical factors.~   "
28323|NCT02686411|"~     Objectives:~      Primary Objective:~      To determine the change of satisfaction with quality of care after an experience on the~     Palliative Care Unit (PCU) for both patients and caregivers, as determined by the global~     rating survey.~      Secondary Objectives:~        1. To determine the change of the quality of care as determined by patients and caregivers~          utilizing validated assessment tools and global rating survey assessing different~          aspects of care after PCU.~        2. To determine domains of care that are strongly or poorly provided by the PCU, as~          reported by patient and caregiver opinions on quality of care.~        3. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis;~          reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea~          of transfer to the PCU; Memorial Delirium Assessment Scale (MDAS), Edmonton Symptom~          Assessment Scale (ESAS) and distress thermometer) may correlate with patient and~          caregiver relative satisfaction with PCU care measured by global survey and with the~          Family Satisfaction with End-of-Life Care.~   "
28324|NCT02686398|"~     During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study.~     The patients were randomized into two groups (MF59-adjuvanted vaccine group or~     non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were~     collected prior to vaccination and at 1and 6 months post vaccination. Levels of~     hemagglutination inhibition (HI) antibodies were measured.~   "
28325|NCT02686385|"~     Intervention - Subjects will be randomized to 2 groups~      Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)~      Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing~      Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1~     hour~      Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h~      Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h~        -  Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test~          at regular intervals.~        -  Stopping rule-Development of sepsis, worsening of Liver functions.~   "
28326|NCT02686372|"~     Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients,~     while treatment measures are limited. This study plans to recruit 10 subjects with Hepatitis~     B virus (HBV) related HCC after liver transplantation. The objective of the study is to~     assess the safety, tolerability and effectiveness of the HBV specific T cell receptor~     (HBV/TCR) redirected T cell in the target population.~   "
28327|NCT02686359|"~     If epidemiological studies indicate relatively low prevalence reported in the general~     population, idiopathic burning mouth syndrome (BMS) is a common condition among certain~     groups of the population: 30% of menopausal women experience oral burning to varying degrees~     . Despite significant progress made in recent years, in understanding the physiopathogeny,~     treatment options remain limited and disappointing,resulting in an impairment of the quality~     of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify~     the causes and effective treatment modalities for subjects suffering is essential.~   "
28328|NCT02686346|"~     This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose~     escalation design to explore the safety and assess the recommended phase 2 dose of~     Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen.~      The second part, depending on the selected dose after the completion of phase Ib part of the~     study, will further explore safety in addition to efficacy of the recommended dose of~     Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin~     lymphoma.~   "
28329|NCT02686333|"~     This study examines the use of brief meditation interventions for patients with symptoms of~     anxiety and depression who are undergoing dialysis. Half of the participants will receive~     meditation interventions 3 times a week, while the other half will receive treatment as~     usual. This study will examine whether meditation is feasible and whether it has any effect~     on reducing symptoms of anxiety or depression.~   "
28330|NCT02686320|"~     Rheumatoid arthritis (RA) is associated with a higher prevalence of infections,~     malignancies, osteoporotic fractures and cardiovascular diseases. Few data are available~     regarding the prevalence and severity of these comorbidities in elderly RA patients. The~     purpose of this study is to determine the effect of age on prevalence and severity of~     comorbidities in RA.~   "
28345|NCT02686125|"~     To compile characteristics of real-world outcomes of Boston Scientific Corporation's~     commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of~     dystonia.~   "
28331|NCT02686307|"~     During tachyarrhythmias, central venous pressures increases while arterial blood pressure~     (BP) decreases. The result is mixed messages to the central nervous system. On one hand, the~     unloading of the arterial baroreceptors results in reflex tachycardia and an increase in~     sympathetic nerve activity (SNA). On the other hand, the increase in filling pressure and~     thus the activation of the cardiopulmonary baroreceptors result in reflex bradycardia and~     sympathoinhibition. The investigators have previously shown that during supraventricular and~     ventricular tachycardia, arterial baroreflex gain (BRG) predominates with minimal~     contribution from the cardiopulmonary BRG. In addition, the investigators found that~     arterial BRG directly correlates with BP recovery following tachycardia termination. The~     roles of the arterial and cardiopulmonary BRGs during ventricular fibrillation (VF) however,~     remain unknown. Furthermore, the role of the arterial BRG in determining 1) BP recovery~     following VF induction and 2) the frequency of ventricular tachycardia (VT)/VF events in~     patients undergoing implantation of an implantable cardioverter/defibrillator (ICD) remain~     unknown. Analysis of the changes in sinus node cycle length during VF inductions in patients~     undergoing the implantation of a dual chamber or triple chamber ICD, provide a unique~     opportunity at looking at the autonomic changes that accompany VF.~   "
28332|NCT02686294|"~     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine~     after multiple oral administration of TALION tab., a IR formulation of bepotastine as~     reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male~     adults. Additionally the safety and tolerability of two drugs will be evaluated.~   "
28333|NCT02686281|"~     The purpose of this study is to determine the toxicity, tolerability and safety of single~     ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.~   "
28334|NCT02686268|"~     This research study is being performed to better understand a specific form of Amyotrophic~     Lateral Sclerosis (ALS) caused by a mutation (or abnormality) of the C9ORF72 gene. This~     mutation is the most common genetic cause of ALS, and is present in 40% of ALS patients with~     a family history of ALS and 5-10% of ALS patients without a family history of ALS.~   "
28335|NCT02686255|"~     Many toddlers and children are released home with relatively low hemoglobin levels following~     cardiac surgery, and with no careful follow up, at an age at which anemia is common. At this~     age, breast milk and its substitute do not provide enough iron, and parents are not adherent~     enough to iron supplements. Due to these facts, there is high importance, especially in~     children suffering from heart defects, for close follow up on their hemoglobin levels.~     Studies following hemoglobin trend post cardiac surgery were never done with children.~   "
28336|NCT02686242|"~     Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of~     hemorrhage, most parturients with placenta previa have to accept cesarean section. In this~     study investigators compare the effect of different anesthetic techniques on these patients.~   "
28337|NCT02686229|"~     The LoG-Glio-Registry is based on a network of german hospitals gathering radiological,~     clinical, epidemiological and molecular data on all patients diagnosed with a low grade~     glioma.~   "
28338|NCT02686216|"~     Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease~     patients and healthy subjects.~   "
28339|NCT02686203|"~     evaluating The Investigational Therapy effects on quality of life, pain and patient's~     clinical status in adult cancer patients with solid tumors who are no longer candidates for~     active oncological therapies.~   "
28340|NCT02686190|"~     Background: Management of patients with Alzheimer's disease associated with behavioral~     disturbances is difficult especially in those with agitation/aggression and insomnia and~     nighttime behaviors. No treatment has shown any efficacy to control these disturbances and~     psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects.~      Objective: Assess the effect of bright light therapy on behavioral disturbances of patients~     with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and~     nighttime behaviours.~      Study design: Multicenter non pharmacological intervention trial, controlled, randomized,~     open, two-arm design : control group and intervention group.~      Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards.~      Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable~     Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression~     (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric~     inventory, nurse scale (NPI-nurse).~      Treatments: Intervention group: patients will participate in a program of bright light~     therapy realised during a one-hour sessions of occupational therapy,. These sessions will be~     realised for groups of 6 patients and will be done every week day, at late morning, for 4~     consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light.~     Patients of control group will participate in a program of occupational therapy of same~     duration and rhythm, realised in standard light conditions (about 300 lux).~      Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after~     the beginning of the programs. Assessment will comprise ; NPI-nurse scale and~     Cohen-Mansfield scale for behaviour disturbances, wrist actimetry for sleep and nighttime~     behaviours (total sleep length, nocturnal wake episodes and nocturnal motor agitation).~      Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale.~     Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield,~     total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry.~      Statistics: Changes in agitation/aggression scores od the two groups will be compared by~     Mann and Whitney test.~      Expected results and perspectives; If bright light exposure is efficient, professional~     caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological~     approach to improve behaviour and sleep of these patients. This study might contribute to~     better define the place of a non invasive and promising technique, wrist actigraphy, to~     assess sleep and behaviour disturbances in psychogeriatric patients~   "
28341|NCT02686177|"~     GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their~     efficacy is documented. However, safety aspects are also important to evaluate with respect~     to micro and macrovascular complications associated with T2D. Few studies have properly~     addressed the role of GLP-1-based therapies in regulating vascular integrity and~     angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both~     ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis~     biomarkers in type 2 diabetic patients.~   "
28342|NCT02686164|"~     This is a multicenter, open-label, non-randomized Phase 1 study in participants with~     advanced solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after~     treatment with approved therapies, or for which there are no standard therapies available.~     The study will also include participants with radioiodine-refractory differentiated thyroid~     cancer (RR-DTC). Its primary intent is to determine the effect of lenvatinib on CYP3A4~     activity as well as to assess the safety and activity of lenvatinib in these participants.~     The study will be conducted in the following 3 phases: Pretreatment Phase, Treatment Phase,~     and Extension Phase.~   "
28343|NCT02686151|"~     To investigate the effect of letrozole in patients who have high risk of ovarian~     hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were~     calculated between letrozole group and supporting treatment group.~   "
28346|NCT02686112|"~     The study aims to quantify the relations between first & second trimester bleeding and~     maternal & neonatal morbidity. Additionally, the study will help in assessing the risk for~     abortions in women with threatened abortions and the risk factors for threatened abortion.~   "
28347|NCT02686099|"~     The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a~     cerclage material into a single sternal closure system. The cerclage material serves to~     facilitate sternal approximation, and the plates and screws serve to provide rigid fixation~     and prevent sternal movement and separation. The combination of a cerclage material in~     combination with plate and screw fixation may also lead to increased stability compared to~     either method used as a standalone means of closure.~   "
28348|NCT02686086|"~     Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of~     inhalation therapy. The response to treatments is dose dependent thus applying the most~     efficient device to administer the treatment is integral. Evaluation of the efficacy of~     nebulisation devices in the treatment of COPD is limited. Technological development in~     recent years has led to new devices that optimize lung deposition and reduce the time needed~     for treatment.~      The aim of this study is to compare the vibrating mesh and jet nebuliser methods of~     delivering bronchodilator medication to patients hospitalised with an acute exacerbation of~     COPD, with respect to lung function and efficacy in spontaneously breathing patients.~   "
28349|NCT02686073|"~     Study the rate of progress of labor among nulliparous women belonging to different body mass~     index groups, & observe how does this variation in maternal body mass index may affect the~     course of labor.~   "
28350|NCT02686060|"~     While venous access is an essential part of caring for the preterm neonate potential severe~     adverse events, including contamination of fluids with bacteria, endotoxins and particulates~     could occur (Bethune 2001).~      Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated~     from the catheter tubing, the ports, at the cannula site or from contaminated infusion~     fluid. While not all infections lead to septicaemia, immuno-compromised patients such as~     neonates are at greater risk, and infection becomes a major problem (Ng 1989) and a major~     risk factor for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated~     that endotoxins may be involved in the pathogenesis of a proportion of cases of~     periventricular leukomalacia, the most frequent brain damage associated with neurocognitive~     handicaps in the human neonate (Volpe 2001).~      The presence of calcium in parenteral nutrition mixture leads to precipitation due to its~     incompatibility with the other components of the admixtures and leads to high concentration~     of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including~     phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a~     common finding in necrotizing enterocolitis another serious complication flowing preterm~     birth (Ballance 1990). Particle contamination of infusion solutions exists despite a~     stringent infusion regiment. The number and composition of particles depends on the~     complexity of the applied admixtures (Jack 2010).~      Particulate contamination is due to drug incompatibility reactions or their incomplete~     reconstitution during the preparation process (Schroder 1994). Various studies have~     demonstrated the contamination of infusion solutions with glass particles from opening glass~     ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition~     components (Ball 2003). Particles have also been shown to be inherent to generic drug~     formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one~     million infused particles per day, increasing with the complexity and quantity of the~     administered infusions (Walpot 1989).~      There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous~     solutions, and the 1.2 micron filter is recommended for larger molecule solutions such as~     lipids. The 0.2 micron filter has also been reported to remove air, microorganisms and~     particulate matter. In addition, endotoxin retention is reportedly achieved by using a~     positively charged filter membrane; toxic macro-molecules are released by gram-negative~     bacteria and are claimed to be effective for up to ninety six hours (Bethune 2001).~      In-line IV filters are currently claimed to be an effective strategy for the removal of~     bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball~     2003) and particularly effective in the removal of particles caused from drug precipitate~     such as antibiotics (Chee 2002; Ball 2003).~      However, evidence of the beneficial effect of in-line IV filters in children and neonates is~     much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the~     population of preterm infants, no study is currently available while particulate~     contamination due to infusion therapy carries a higher health risk in this subpopulation.~      The benefits of using IV in-line filters in critically-ill preterm neonates remains to be~     demonstrated. This intervention in adults has also been challenged by several authors~     (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may~     be retained in the filters causing a reduction in potency (Friedland 1985). On the other~     hand, there are no known adverse effects from the use of IV in-line filters.~   "
28351|NCT02686047|"~     Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA).~     There is no well controlled trial comparing one injection regimen of HA for the treatment of~     knee OA. The purpose of this study was to compare the efficacy and safety of one~     intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the~     treatment of knee OA.~   "
28352|NCT02686034|"~     This study is a prospective, multi-centre, randomised, double-blind, sham-controlled~     investigation designed for comparison of two parallel treatment groups: gammaCore (active~     nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine~     attacks~   "
28353|NCT02686021|"~     Postoperative pain is common and particularly outpatients may experience unsatisfactory pain~     relief. This randomized, double-blind, crossover study of postoperative pain in outpatients~     undergoing split-mouth, third lower molar extraction aims to examine whether or not the~     combination of metamizole and ibuprofen is superior to either drug alone.~   "
28354|NCT02686008|"~     This is an open label pilot study evaluating the pharmacodynamics and safety of single agent~     olaparib administered at 300mg bid (twice a day) for 14 days orally in patients with human~     papillomavirus (HPV) -positive and human papillomavirus (HPV)-negative head and neck~     squamous cell carcinoma (HNSCC)~   "
28355|NCT02685995|"~     Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled~     dialysis catheters.~   "
28356|NCT02685982|"~     Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with~     persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced~     social functioning, and impaired quality of life. MDD is estimated to affect approximately~     2% of Canadian women and 1% of Canadian men at any point in time. The World Health~     Organization affirms that depression is the leading cause of disability worldwide, with~     increasing global economic impact.~      Standard treatments for depression include basic psychosocial support combined with~     antidepressant medication or psychotherapy. It has been observed, however, that only 50% of~     individuals respond to psychological treatment, and only 30-40% of patients achieve full~     remission after initial treatment with antidepressants. Music- and sound-related therapies~     have the potential to serve as adjuncts to, or facilitators of, medication.~      In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic~     Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic~     Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses~     of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity.~     Participants in this study will undertake 30 minutes of daily music intervention~     self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess~     depression symptoms, sleep quality, quality of life, and brain activity pre- and~     post-treatment.~      The results of the present study will help to better understand the effectiveness of~     Rhythmic Sensory Stimulation to the treatment of mood disorders, and contribute to the~     development of future studies to investigate the neural driving effects of therapies based~     on Rhythmic Sensory Stimulation.~   "
28357|NCT02685969|"~     Study to understand factors related with the preclinical stages of Alzheimer's Disease and~     investigate markers that predict its progression.~      Cross-sectional and single arm study performed on a subgroup of individuals recruited in the~     ALFA project.~      Study without therapeutic interest for the research participants (440 participants of the~     ALFA project who have been selected for being cognitively healthy and in their vast majority~     are direct descendants of patients diagnosed with Alzheimer's Disease).~      Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according~     to their clinical characteristics, their compliance to selection criteria and their desire~     to participate in this study.~      After signing this study's specific informed consent form, the neuropsychological screening~     and the brain MRI acquisition will be performed. Once all inclusion criteria are checked,~     the PET scans with 18F-Flutemetamol and 18F-FDG will be performed~   "
28358|NCT02685956|"~     The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2~     Qualitative PCR Test. Precision of results and concordance of results with a reference assay~     will be evaluated.~   "
28359|NCT02685943|"~     Although suicide risk is highly prevalent among the patient population in mental health~     care, remarkably little research exists on effective treatments. Among a small set of novel~     approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a~     randomized controlled trial at four departments in Vestre Viken Hospital Trust,~     hypothesizing CAMS to be the superior approach. Primary outcome measures are suicidal~     ideation and suicide attempts, with secondary outcome measures including general symptoms of~     mental health problems. Changes in the outcome measures are compared between the two groups~     from baseline to 6 and 12 months after patients are included in the study. The study has the~     potential to impact the science of treating suicidal individuals and it could benefit the~     general public by establishing CAMS as an effective clinical approach for rapidly reducing~     suicide risk.~   "
28360|NCT02685930|"~     The purpose of this observational study is to collect prospective data on the occurrence of~     bacterial and viral pneumonia in the ICU setting. Current classification systems for~     pneumonia promote over treatment with antibiotics as they do not specifically recognize the~     presence of culture-negative and viral pneumonia. The investigators will collect data to~     determine if a novel pneumonia classification system can be developed that more accurately~     links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia,~     antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to~     clinical outcomes. Additionally, the investigators will collect data on the practice of~     antimicrobial stewardship in the ICU setting to determine if further improvements in~     antibiotic practices can be accomplished in the future.~   "
28361|NCT02685917|"~     The quality of cartilage regeneration after marrow stimulation is well documented to be~     unpredictable, because they do not regenerate consistent amount of cartilage. To overcome~     the shortcomings of the microfracture technique, various augmentation techniques using~     synthetic collagen matrix, scaffolds or plug devices have been developed. However, their~     efficacy remains unclear. The purpose of this prospective randomized controlled study is to~     evaluate whether the microfracture in combination with collagen gel augmentation could~     improve the quality of cartilage regeneration in patients undergoing medial open wedge high~     tibial osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis~     (OA).~   "
28362|NCT02685904|"~     This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study~     to evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The~     study period for each patient will be 27 weeks, during which the patient will undergo~     screening for up to 21 days, and followed by treatment of 24 weeks and follow up period of 2~     weeks. Each patient will be required to make a total of 9 visits.~      After re-confirming the eligibility of patients at Visit 2, eligible patients will be~     randomly assigned to either treatment group or control group in a 2:1 ratio. In addition,~     patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous~     injection while patients in the control group will receive placebo solution twice weekly by~     subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to~     week 24 and follow up period of 2 weeks.~      The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI,~     BASMI and individual measures of disease activity, such as numbers of swollen and tender~     joints, ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9.~     Safety will be evaluated according to the frequency of adverse events, vital signs, physical~     examination, laboratory abnormalities, and ENIA11 antibody formation.~   "
28363|NCT02685891|"~     In this study, the investigator evaluates whether there are age-specific diurnal changes in~     markers of cortical plasticity in children, adolescents and adults. The question will be~     investigated by the quantification of brain metabolites and structural brain volumes using~     magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography~     (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity~     change depending on a modulation of sleep by applying tones during deep sleep.~   "
28364|NCT02685878|"~     The purpose of this study is to describe the long-term surgical success, quality of life,~     prevalence of depression, fertility rates, and pregnancy outcomes of patients who have~     undergone obstetric fistula repair.~      This will be a study involving up to 300 women 1-3 years after they have undergone obstetric~     fistula repair at the Fistula Care Center in Lilongwe, Malawi.~      Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014~     will be identified from an existing database of fistula patients. They will then be~     contacted and invited to participate in the study. Consented patients will complete a 1-hour~     pad weight to evaluate urinary continence, a demographic questionnaire, an~     incontinence-related quality of life metric, and a depression metric. The data will be~     analyzed and then disseminated to stakeholders.~   "
28365|NCT02685865|"~     The research design is a randomized prospective clinical trial comparing Endoscopic~     ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be~     conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.~   "
28366|NCT02685852|"~     The purpose of the study is to evaluate the effectiveness of exenatide in adults~     experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric~     surgery.~   "
28367|NCT02685839|"~     Elderly care has become one of the most important subjects in Taiwan and frailty syndrome~     are the most common problems among the elderly. In view of this trend, Taipei Veteran~     Memorial Hospital imported POWER rehabilitation from Japan in 2008. While showing~     significant clinical benefits, investigators have found that the system still has certain~     limitations (e.g. high cost, requires large space, patients must commute to the center,~     lacks real-time objective feedback , boring routines makes staying power to motivate~     patients for long term rehabilitation programs.)~      To overcome the above limitations, this project proposes an evidence-based rehabilitation~     model that accounts for actual clinical need and collaborates with our engineering team to~     develop a cluster , wearable and Brain-Computer Interface System version of POWER~     rehabilitation system. Combining cloud technology, investigators now introduce~     internet-of-things into the POWER rehabilitation procedure. The result will lower the burden~     of clinical support personnel, and provide an opportunity to quantify frailty syndromes so~     as to allow objective and quantitative scientific evaluation, leading to a more objective~     clinical diagnosis.~      In addition, this project further proposes a virtual-reality (VR) system for POWER~     rehabilitation, as well as designs for the VR sceneries. Through the use of different~     animated 3D VR sceneries and interactive game design, investigators can make rehabilitation~     interesting and fun for the patients, motivating long-term compliance of the patients,~     thereby, improving the clinical outcome of POWER rehabilitation.~      This project has the potential to create an innovative solution to address the current~     bottlenecks of our rehabilitation treatment model. Successful development of the system will~     offer rehabilitation clinicians more treatment options, lower the cost of supporting staff,~     reduce commuting cost for the patients, and elevate patient desire to comply with the~     treatment program. Finally, the system will not only enhance Taiwan's academic reputation in~     the international arena, it will also generate new commercial opportunities for Taiwan and~     contribute to Taiwan economic development.~   "
28368|NCT02685826|"~     This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and~     regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone~     (dex) in subjects with Newly diagnosed multiple myeloma (NDMM).~      The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to~     determine the optimal regimen.~   "
28691|NCT02681601|"~     There are few well-designed studies evaluating the effect of nutrition support in patients~     with cancer cachexia. The aim of this study is to examine the effect of dietary prescription~     with and without nutrition supplementation in patients with unresectable pancreatic cancer~     on body weight, body composition, total calorie intake, quality of life and blood~     inflammatory markers.~   "
28369|NCT02685813|"~     Neural tube defects cover a group of severe embryo malformations such as anencephaly and~     spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand~     lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians,~     obstetricians, pediatric neurologists, pediatric urologists, gastroenterologists,~     psychologists and social workers. The disabilities involve morbidity such as decreased motor~     and sensory function caudal to the lesion, hydrocephalus, scoliosis, bladder and bowel~     incontinence as well as increased mortality.~      In 2004, the Danish Health Authorities introduced new guidelines for fetal diagnostics.~     These represented a change of paradigm stating that all pregnant women should be offered a~     prenatal examination including an ultra sound scan in week 12-13 of gestation (including~     risk estimation of chromosomal diseases) as well as in week 19 of gestation (scanning~     primarily for malformations). The examination program was not elaborated to eradicate~     diseases but to support the reproductive autonomy of the pregnant women, including the~     possibility to seek for termination of the pregnancy in the case of severe disease in the~     fetus.~      Severe spina bifida is one of the malformations that can be diagnosed with the ultra sound~     scan in week 19, and since the implementation of the new guidelines from the Danish Health~     Authority a study by this research group has shown decreased birth incidence at least in the~     Western part of Denmark.~      It is still unknown what has caused this decrease as is the exact number of pregnancies and~     births complicated by spina bifida in the child; similarly it is unclear whether this~     decline is a regional or if it is only a Danish phenomenon.~      By extraction of data from the Danish Fetal Database (FØTOdatabasen) which includes~     information of all 60.000 pregnancies in Denmark annually, the purpose of this register~     study is to investigate the incidence of pregnancies complicated by prenatal diagnosis of~     spina bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases~     (including termination of pregnancy). Furthermore results will be compared to results~     obtained by collaborative partners in Sweden and hopefully also in Saudi Arabia.~   "
28370|NCT02685800|"~     Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility~     problems. However, despite ART treatment options have evolved over time, the implantation~     rate remains rather low.~      A possible role for inherited and acquired thrombophilias has been invoked, especially in~     women with previous implantation failures. However, several factors could play a role in~     these conditions.~      A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes,~     independently of the presence of thrombophilia, has been recently suggested.~      This register is designed in order to better define all possible variables influencing ART~     outcome and improve clinical management of women with previous implantation failures. During~     this study the investigators will collect and evaluate clinical data regarding the first~     cycle in women with previous ART failures.~   "
28371|NCT02685787|"~     This randomized trial evaluates the efficacy of counselling for reducing anxiety and~     depression in caregivers of patients with dementia. Half of the participants will receive~     six hours providing counselling and psycho-social support to caregivers along with a~     specific telephone support service - Ad Hoc Telephone Counselling whereas the remaining~     participants will receive six hours providing general information about Alzheimer Disease.~   "
28372|NCT02685774|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.~   "
28373|NCT02685761|"~     It is the purpose of this study to evaluate the relationship between a low transverse,~     vertical midline, and supra-panicular high transverse skin incisions and the rate of wound~     complications in women with a BMI of 40 or greater undergoing a cesarean section for~     delivery. So far, the choice of incision for the morbidly obese is based only on case~     reports. No randomized controlled trials have been done up to date comparing these methods.~     It is our hope that a high transverse incision will have all of the benefits of a low~     transverse skin incision, with the added benefit of better exposure offered by a vertical~     midline incision, without the added increased risk of subjecting the woman to a vertical~     hysterotomy.~   "
28374|NCT02685748|"~     In this double blind randomized clinical trial the investigators are going to exam influence~     of adjuvant Aspirin therapy on soft neurological signs (Heidelberg scale), positive and~     negative symptoms (PANSS), cytokine profile and inflammatory factors, as well as on~     cognition (MoCA) in young psychotic patients.~   "
28375|NCT02685735|"~     The objective of this research study is to better understand patterns of recovery after~     Total Knee Arthroplasty (TKA). The study will evaluate how pain, activity and cognitive~     (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate~     the efficacy of gabapentin versus placebo for improving recovery after surgery.~   "
28376|NCT02685722|"~     This study for a six-month trials, Randomized, open, and parallel comparison before and~     after its own, Stage test includes screening stage, treatment period and follow-up period.~     In accordance with chronic wound criteria for the patient, By producing the principle of~     random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers~     according to the situation of wound healing time and decided to use the secondary treatment,~     To observe the clinical efficacy and safety.~   "
28377|NCT02685709|"~     Octreotide capsule is a novel, orally-administered formulation of the commercially-available~     injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated~     sustained biochemical response up to 13 months in patients with acromegaly previously~     managed with somatostatin analog injections (ref).~      The purpose of this study is to compare the efficacy safety and patient reported outcomes~     between oral octreotide capsules and injectable somatostatin analogs.~   "
28378|NCT02685696|"~     Objective:~      To investigate if the use of the newly designed Alexis O Retractor leads to improved~     intra-operative and post-operative surgical outcomes in the setting of planned elective~     Caesarean Sections.~      Study Design:~      This ethically approved study is designed as a prospective, randomized controlled trial in~     planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O~     Retractor group or the conventional group. Patients with wound healing problems, connective~     tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal~     surgery and chorioamnionitis are excluded. Outcomes include surgical site infection,~     intraoperative parameters such as tissue damage, postoperative analgesia requirements and~     patient satisfaction scores.~   "
28379|NCT02685683|"~     This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once~     daily in patients with active Crohn's Disease~   "
28418|NCT02685176|"~     This Clinical trial is being conducted to study the effectiveness of heat donation through~     head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia.~     The purpose of the study is to compare the core rewarming effectiveness of the same amount~     of heat donation through the head or torso in treatment of hypothermia using a human model~     for severe hypothermia. The information obtained from this study will give a better~     understanding of heat-transfer mechanisms. This might help in the ongoing research in~     hypothermia treatment.~   "
28380|NCT02685670|"~     This is a single-arm open-label phase I/II study to determine the relative superiority of~     αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment~     potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer~     immunotherapy, treatments aiming to arm patients with immunity specifically against cancer~     cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs~     against B cell malignancies have demonstrated remarkable potential. In this trial, all~     subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells~     in equal number to test a hypothesis that CD137-costimulation can promote the persistence~     and engraftment of CAR-T cells and this superiority can lead to improved progression-free~     survival.~   "
28381|NCT02685657|"~     The purpose of this study is to increase survival of patients with early and locally~     advanced triple-negative breast cancer adding selumatinib to standard preoperative~     chemotherapy regimen.~   "
28382|NCT02685644|"~     Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for~     treatment of endometriosis. However there is evidence that intervention may effect ovarian~     reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the~     topic are contradictory and employed research methodology are diverse. There is need for an~     adequately powered research with proper methodology to assess actual effects of surgery.~   "
28383|NCT02685631|"~     This research registry studies Yttrium Y 90 resin microspheres in collecting data from~     patients with liver cancer not capable of being removed by surgery (unresectable) for the~     radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable~     (RESIN) liver tumor registry. The information generated will help doctors better understand~     treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes~     for patients, as well as guide future research for using Y90 therapy, especially for those~     conditions where data is currently very limited or lacking.~   "
28384|NCT02685618|"~     Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure~     target in addition to standard therapy, as compared to standard therapy alone, in~     post-cardiac-arrest-syndrome (PCAS) patients.~      Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may~     improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous~     prostanoid which is formed and released by endothelial cells with anti-platelet,~     vasodilatory and cytoprotective properties36 and is expected to be beneficial by protecting~     and deactivating the endothelium and by restoring vascular integrity in patients suffering~     from endothelial breakdown.~      Trial Population: Participants in the trial must be adult patients (≥18 years of age) with~     out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of~     Cardiology, 2143, Rigshospitalet, Copenhagen.~      Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in~     40 OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo~     (saline) infusion.~      Patients in both randomization groups will be treated in accordance with state-of-the art~     therapy including targeted temperature management. Interventions are considered emergency~     procedures and study drug infusion should be commenced as soon as possible after sustained~     return of spontaneous circulation (ROSC), screening and randomization.~      Patients will only be enrolled after informed consent, but as the treatment has to be~     initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a~     time-point where patients are temporarily incompetent, scientific guardians will co-sign the~     informed consent form before inclusion. Next-of-kin and the patients' general practitioner~     will co-sign as soon as possible and the patient will provide informed consent whenever~     possible.~      During the study, blood samples will be taken at different time points. Patients will be~     observed and assessed continuously with regards to complications including bleeding.~     Patients will be actively assessed as long as the patient is in the ICU. During the extended~     follow up period at day 30, 90 and 180 contact will be made with the patients to follow up~     on safety events and vital status.~      The trial is conducted in accordance with the protocol and is approved by Danish health and~     medicines authority, Danish ethics committee and danish data protection agency.~      Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin®~     administered as a 48h continuous i.v infusion. The drugs will be administered according to~     the product specifications.~      Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v~     volume of placebo saline to be administered is equal to the administered volume of diluted~     (in 0.9% saline) active drug.~      Sponsor of study and financial support: This research project is investigator-initiated by~     the trial Sponsor Pär I. Johansson in collaboration with the principal investigator~     Christian Hassager.~      It has not received funding from any commercial sponsors.~      Patient recruitment period runs from February 2016 to June 2017. Follow-up data on 30-day,~     90-day and 180-day outcome and adverse events will be collected. Initial data analyses will~     be done after completion of 30-day follow-up for all patients. Secondary data analyses will~     be done after completion of 180-day follow-up for all patients.~   "
28385|NCT02685605|"~     INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical~     phase III trial which tests if the median progression-free survival (PFS) of patients with~     newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of~     intraoperative radiotherapy (IORT) to standard radiochemotherapy.~   "
28386|NCT02685592|"~     This study investigates the efficacy of photodynamic therapy (PDT) in the treatment of~     lentigo maligna (LM). Hyperspectral imaging system (HIS) will be used to determine the~     margins of LM and to rule out possible invasion. Participants will receive photodynamic~     therapy three times consecutively with intervals of two weeks using 5-aminolevulinic acid~     nanoemulsion (BF-200 ALA, Ameluz®) as a light sensitizing cream. Four weeks after last~     photodynamic therapy the lentigo maligna lesion will be excised surgically from the skin.~     Result of the treatment is assessed with histopathological examination and~     immunohistochemical staining of removed tissue specimen.~   "
28387|NCT02685579|"~     Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular~     nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.~   "
28388|NCT02685566|"~     The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study~     Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are~     properly trained in the reading and interpretation of FFDM and DBT images.~   "
28389|NCT02685553|"~     The purpose of this study is to determine whether the use of Near-Infrared Technology can~     guide the laparoscopic resection of hypervascular neoplasms of the pancreas.~   "
28390|NCT02685540|"~     Death rate in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients.~      In the investigators study, the investigator will review the death rate in anesthesia~     whether regional or general over the past five years from 2010 to 2014, by examining the~     patients records from the hospital database.~   "
28391|NCT02685527|"~     Isolation of contagious patients is expensive, requires more caregiver time, most of the~     patients perceive isolation as a mental strain and it has been shown that the level of care~     and observation is lower than in a normal ward. But isolation of contagious patients is~     necessary to protect other patients, hospital staff and relatives to prevent spreading of~     infection and, in worst case out-break.~      There are different isolation regimes available depending on causative agent and mode of~     transmission. A community-acquired acute gastroenteritis (GE) is most often caused by~     Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium~     difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in~     single rooms with strict contact precautions. Patients infected with acute GE caused by~     other pathogens can be isolated in a multi-bed room if there is a private toilet.~      However, at the time of arrival to hospital it is not known if the patient is contagious.~     The indication of isolation has to be made based of a clinical evaluation in risk of~     isolating to few or too many patients.~      Aim of the study:~      To identify anamnestic, clinical and paraclinical variables that can be used as indicators~     of the aetiology of infectious GE, thus giving an indication for isolation.~      To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR~     analysis test to identify infectious GE compared to gold standard methods.~   "
28392|NCT02685514|"~     To evaluate the short-term efficiency and safety of HIFU treatment in the relapsed Graves'~     disease.~   "
28393|NCT02685501|"~     As combat women soldiers are required to more intensive daily activity the investigators~     believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as~     characterized by, anemia iron deficiency and reduced quality of life)) on personal~     performance will be more significant in combat women soldiers compared to non-combat women~     soldiers. Using cohorts from the same environment will enable the investigators to better~     study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors,~     such as nutrition. The study does not include any intervention.~   "
28442|NCT02684864|"~     Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee~     drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this~     non-interventional cohort study. The aim is to investigate whether measurement of an~     individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms~     predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.~   "
28394|NCT02685488|"~     Depression is the leading cause of disability worldwide. Because a significant number of~     people with depression do not respond to medication or therapy, alternative treatment~     options are greatly needed. Recent research has focused on brain stimulation methods due to~     their therapeutic utility for treating depression. Yet, current brain stimulation methods~     have drawbacks, including invasive surgery and limited precision in targeting specific~     areas. A novel brain stimulation method, transcranial ultrasound (TUS), is noninvasive, has~     greater spatial precision than most existing methods, and is proven safe for humans. TUS has~     been found to increase positive mood in chronic pain patients. In a double blind study, TUS~     increased positive mood in over 140 healthy undergraduates at the University of Arizona.~      Despite evidence that TUS can increase positive mood in humans, it has yet to be~     investigated whether TUS can increase positive mood in humans who are experiencing chronic~     low mood or depression. The present study will, for the first time, examine whether TUS can~     improve depressive symptoms. Twenty to thirty participants with mild to moderate depressive~     symptoms (Beck Depression Inventory Score between 10 and 25) will be randomly assigned to a~     TUS sham or TUS activation condition. In the TUS activation condition, TUS will be used to~     stimulate the right fronto-temporal area, which has previously been shown to increase~     positive mood. Participants in the TUS sham condition will not receive any brain~     stimulation. Participants will attend five sessions within seven days or ten sessions within~     fourteen days. At each session, in addition to brain stimulation, self-reported mood and~     depressive symptoms will be recorded. Furthermore, the investigators will use~     electroencephalogram (EEG) to record changes in brain electrical signals during TUS~     stimulation. Based on prior research, the investigators predict that mood will increase and~     depressive symptoms will decrease with TUS stimulation.~   "
28395|NCT02685475|"~     Background and objectives: The investigators performed this study to explore whether the~     presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus~     blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary~     hypothesis was that the sensory block duration would be delayed in diabetic patients.~      Methods: After obtaining ethics committee approval and written informed consent, 71 patients~     were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics~     were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL~     lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and~     secondary outcomes were sensory and motor block onset times, motor block duration,~     time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores and rescue~     analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were~     assessed by a blinded investigators.~   "
28396|NCT02685462|"~     This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in~     Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of~     HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)],~     Caffeine and Digoxin~   "
28397|NCT02685449|"~     This is a randomized, cross-over study. The aim of this study is to compare the~     post-prandial glycaemic variability after pure protein meal following with an administration~     of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.~      Prolonged post-prandial glycaemic variability will be identified using the self-monitoring~     of blood glucose (10-point curve) and CGMS.~   "
28398|NCT02685436|"~     Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined~     multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid~     laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux~     esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and~     exacerbations recurrence.~   "
28399|NCT02685423|"~     Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual~     input across the two eyes during childhood. It is difficult to treat in adulthood because~     the visual system becomes less plastic (able to learn) with age. The purpose of this study~     is to determine whether five to ten days of visual deprivation--living in complete~     darkness--can enhance plasticity in the visual cortex and thereby facilitate the learning~     that is needed to recover visual function in amblyopic adults.~   "
28400|NCT02685410|"~     As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based~     interventions targeting risk reduction and prevention in youth and young adults, this study~     is designed to develop a paper prototype and intervention design manual of an online~     social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention~     in young black women. The ultimate plan is to incorporate focus group participants input and~     feedback into the development of a conceptual model, intervention manual, and videogame~     intervention prototype. This prototype will then be tested using 20 participants and will~     utilize a pre-post design to evaluate the effectiveness of the program.~   "
28401|NCT02685397|"~     This adaptive phase II/III randomized trial is designed to demonstrate that eradication of~     oligometastases by SBRT is a promising and emerging way to delay disease progression and~     postpone second line systemic therapies in castration-resistant prostate cancer (CRPC)~     patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take~     part in this trial. All participating patients will receive either the standard of care~     (i.e. LHRH agonist in combination with the new generation of hormonal therapy~     [Enzalutamide]) or the experimental treatment (i.e. LHRH agonist in combination with the new~     generation of HT [Enzalutamide] plus the additional SBRT treatment). The patients will~     undergo different evaluations before treatment, such as imaging to confirm oligometastatic~     recurrence and blood tests. Patients will be stratified according to the location of~     metastasis (visceral [with or without bone metastases] vs. bone metastases alone) and PSA~     doubling time (≤ 3 vs. > 3 months). As per the standard of care, patients will have PSA~     testing performed every 6-12 weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA~     progression, whichever occurs first.~   "
28402|NCT02685384|"~     This innovative and timely study will measure the impact of Affordable Care Act (ACA)~     Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health~     outcomes. To assess this natural policy experiment, the investigators will use electronic~     health record data from the ADVANCE clinical data research network (CDRN) of the National~     Patient-Centered Clinical Research Network (PCORnet).~   "
28403|NCT02685371|"~     This study will evaluate the effect of deep breathing manoeuvres on inter ventricular~     interdependency physiology. By providing further insight in this basic physiology we want to~     add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria~     currently used in cardiovascular magnetic resonance.~   "
28456|NCT02684682|"~     The purpose of this blind randomized clinical trial is to evaluate different frequencies in~     self-mechanical control of plaque in individuals with historic of periodontitis and in~     periodic and preventive maintenance in order to assess which frequencies are compatible with~     maintaining gingival health.~   "
28404|NCT02685358|"~     Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition.~     It is associated with compromised health, early mortality, and substantial economic costs.~     PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD~     are not available in the primary care setting. Instead, patients with PTSD are referred to~     mental health settings, yet many patients do not accept these referrals or do not adequately~     engage in such services. Thus, this project seeks to improve health care for Veterans by~     testing the effectiveness of a primary care-based treatment called clinician-supported PTSD~     Coach. In this treatment a primary care mental health clinician guides patients in using the~     PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to~     cope with common PTSD-related concerns. If this treatment is found to be effective at~     reducing PTSD symptoms and increasing use of mental health care, it will provide a~     tremendous benefit to Veterans with PTSD seen in VA primary care.~   "
28405|NCT02685345|"~     The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with~     placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.~   "
28406|NCT02685332|"~     Radiation, Stereotactic Body Radiation Therapy.~   "
28407|NCT02685319|"~     Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging~   "
28408|NCT02685306|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug taxane, will improve the results of~     the treatment for early- stage Triple Negative Breast Cancer followed by Standard- of- Care~     surgery~   "
28409|NCT02685293|"~     This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7~     days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003~     compared with that of Placebo MDI on cardiac stroke volume following chronic-dosing (7 days)~     in subjects with moderate to severe COPD.~   "
28410|NCT02685280|"~     From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to~     capsulotomy in refractory cases of Obsessive-Compulsive Disorder [OCD]. More recently,~     several studies with DBS in patients with major depression have been initiated. In Belgium,~     there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable~     neurostimulators, in these OCD patients.~      Although rechargeable neurostimulators are widely used in spinal cord stimulation for pain~     and DBS for movement disorders, they have not yet been used in DBS for psychiatric disorders~     population. Several possible problems might arise with the use of rechargeable~     neurostimulators in this highly specific population.~      In this prospective study with a before-after design, we would like to determine if the use~     of rechargeable neurostimulators is effective, applicable and safe and capable of~     diminishing the need for neurostimulator replacement procedures.~   "
28411|NCT02685267|"~     This is a prospective randomized phase II clinical trial where patients who are receiving~     enzalutamide in the pre-chemotherapy space are randomized upon objective progression~     (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same~     combination plus enzalutamide.~      The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel~     in patients who failed or progressed while on enzalutamide would increase progression-free~     survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients~     alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL)~     using validated scales.~   "
28412|NCT02685254|"~     This study aims to examine if structured skills training group therapy for ADHD in adults~     has beneficial effects superior to 'treatment as usual' including medication in a controlled~     outpatient setting on clinically relevant outcomes including symptoms, functioning and~     quality of life measures.~      The trial is designed as a multicenter randomized controlled, parallel group study. Patients~     are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial~     intervention by structured skills training groups by weekly sessions or one with control~     condition (treatment as usual). Then after 15 weeks patients in the control condition arm~     are switched to the active intervention by 14 weeks of structured group therapy. All~     patients are assessed for defined outcomes after six months.~   "
28413|NCT02685241|"~     Breath analysis is a non-invasive procedure to detect and monitor diseases and it is~     particularly attractive for patients who have to routinely check biomarkers, such as~     diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data~     in a small study with healthy subjects showed a high correlation between blood glucose~     levels and acetone. Therefore, the objective of this study is to correlate biomarkers~     (glucose level and creatinine, respectively) with the corresponding target breath components~     (acetone and NH3, respectively) detected by portable gas sensors in the general population~     and to assess possible predictive models for biomarker estimations from the corresponding~     target breath component and predictive models to estimate abnormal biomarker concentrations.~   "
28414|NCT02685228|"~     The purpose of this study is to investigate the effect of very low dose decitabine combinate~     with gemcitabine in the first-line treatment of locally advanced, unresectable and~     metastatic pancreatic cancer.~   "
28415|NCT02685215|"~     Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary~     failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive~     factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long~     term follow up after ICU discharge.~   "
28416|NCT02685202|"~     The purpose of this study is to characterize the course of temporomandibular disorder (TMD)~     pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated~     with mandibular advancement splint (MAS) therapy.~      Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA~     (apnea-hypopnea index ≥5 and <30).~      This is an interventional study in which 12 patients receive MAS therapy for comorbid~     TMD/OSA for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy,~     the the effect on MAS therapy on TMD pain in people with OSA is unknown. There is no~     comparison group. Care is being provided under the direction of a sleep physician by a~     dentist who specializes in dental sleep medicine. The investigators expect that as MAS~     therapy reduces the severity of OSA, painful TMD symptoms will also reduce.~   "
28417|NCT02685189|"~     The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data~     from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) An~     Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For~     Exchange Transfusion.~   "
28419|NCT02685163|"~     Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of~     several diseases. Polyphenols, have been shown to be beneficial against ROS.~      This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on~     oxidative stress, vascular function and physical performance. In this controlled,~     single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of~     antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or~     milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two~     hours after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric~     reducing ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress~     (D-Roms and H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test)~     with measurement of the double product were assessed.~   "
28420|NCT02685150|"~     Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence~     Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes~     in the gut caused by reflux disease,either acid reflux or bile reflux, which make it~     possible to differentiate reflux disease from functional dyspepsia (FD).~   "
28421|NCT02685137|"~     This is a randomized, sham-controlled (placebo) trial of a single intramuscular injection of~     Stannsoporfin compared to sham (placebo) in healthy term and near-term newborns admitted~     to the well-baby nursery and enrolled with intention to treat.~   "
28422|NCT02685124|"~     This study evaluates the effect of intake of two orange juice varieties in healthy adults.~     The participants will receive Bahia orange juice, Cara-Cara orange juice or a isocaloric~     control drink in a cross-over study.~   "
28423|NCT02685111|"~     To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with~     Intermittent Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients~     treated with adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) regimen~   "
28424|NCT02685098|"~     Patients undergoing semi-elective below knee amputation from complications associated with~     atherosclerotic limb ischemia will received intra-muscular injections of allogeneic~     Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent~     ischemic wound complications after surgery and decrease the incidence of conversion from~     below knee to above knee amputation.~   "
28425|NCT02685085|"~     Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical~     foley's cather administration and both techniques performed together.~   "
28426|NCT02685072|"~     This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total~     of 50 women who smoke and have regular menstrual cycles will be randomized to either~     progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks.~     TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued~     at the end of Week 8. All participants will also be provided behavioral treatment for~     smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a~     one-week period (Week 1) during the mid luteal phase, within a week before menses and the~     target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will~     have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self-~     report of smoking abstinence, biochemically verified smoking abstinence, measures of~     cigarette craving and nicotine withdrawal, and measures of response inhibition.~   "
28427|NCT02685059|"~     To date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only~     treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes.~     Stimulating the immune cells of TNBC might therefore be an option for these patients to~     increase the pathological complete response. pCR is highly correlated with outcome in TNBC.~      Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an~     additional option for these patients.~   "
28428|NCT02685046|"~     In this proof-of-concept trial the investigators will study the effects of imatinib~     treatment on the biology of mesenchymal-type colon cancers.~   "
28429|NCT02685033|"~     This clinical study will be a single-center, randomized, open-label, active-controlled,~     parallel-group study comparing dalbavancin to standard of care (SOC) therapy in~     osteomyelitis.~   "
28430|NCT02685020|"~     The primary purpose of this study is to assess safety, tolerability of the different vaccine~     schedules (different regimen durations and different number of dose administrations) with~     Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody~     (Ab) responses of the different vaccine schedules.~   "
28431|NCT02685007|"~     The purpose of this study is to describe ease of use and satisfaction with application of~     the pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as~     per Summary of Product Characteristics (SmPC).~   "
28432|NCT02684994|"~     This study will take place over approximately 6 months and includes 3 assessment~     appointments (where information will be gathered, but no direct treatment provided) and 12~     treatment sessions of cognitive processing therapy if eligible.~   "
28433|NCT02684981|"~     The aim of this non-interventional study is to describe patient's perception of~     anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while~     suffering from atrial fibrillation (according to its approved indication in the approved~     dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care~     using Vitamin K Antagonist (VKA).~   "
28457|NCT02684669|"~     In several rodent studies, it has been demonstrated that very high doses of opioid~     antagonists (i.e., naloxone 3-10 mg/kg) administered after weeks after recovery from an~     inflammatory injury may lead to a reinstatement of hyperalgesia and pain behavior. This~     latent sensitization has recently been demonstrated also to take place in humans.~      The present study examines if it is possible to foresee individuals who will demonstrate a~     larger degree of latent sensitization upon challenge with an injury, than others. Using an~     enriched design high sensitizers (e.g., the upper quartile of individuals developing large~     areas of secondary hyperalgesia following a mild burn injury) are compared with low~     sensitizers (lower quartile), regarding the propensity for developing latent sensitization~   "
28693|NCT02681575|"~     The purpose of this study is to examine the initial efficacy of a psycho-social,~     metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit~     Hyperactivity Disorder (ADHD).~      It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate~     improvements in measures of executive functioning, occupational performance and quality of~     life.~   "
28434|NCT02684968|"~     Eligible patients will be randomized 1:1 without stratification to bilateral continuous QL~     catheters with local anesthetic continuous infusion (QL block + IV patient-controlled~     analgesia group) or normal saline continuous infusion (IV patient-controlled analgesia~     group).~      In the postanesthesia care unit (PACU), patients will be given intravenous boluses of~     hydromorphone or fentanyl as needed. Following immediate recovery from anesthesia, patients~     will be provided with a hydromorphone IV patient-controlled analgesia pump with standard~     initial settings and an option of clinician dose for breakthrough pain. IV~     patient-controlled hydromorphone pump settings will be titrated to comfort level (pain~     score<4) by blinded clinicians.~      On the nursing floor, patients will also receive scheduled boluses of of 10 mL 0.1%~     bupivacaine or normal saline from the pump every 4 hours. These scheduled boluses (clinician~     dose) will be administered by the nurse using the medication from the pump.~      If patient agrees ViSi mobile (Sotera Wireless) patient monitoring system will be used to~     continuously record noninvasive blood pressure, patient activity, posture, 3-lead ECG,~     oxygen saturation, and respiratory rate. Data will be recorded at one-minute intervals and~     downloaded daily to a laptop.~      Opioid consumption first 72 hours or until discharge, whichever comes first will be~     recorded.~      Pain scores during first 72 hours or until discharge, whichever comes first will be recorded~     with a verbal rating scale and obtained from the patient's electronic medical records.~      The morning of post operative day 1 and post operative day 3 the ORSDS and QOR surveys will~     be completed.~      Morning of the day of discharge, the overall patient satisfaction with pain management~     survey will be completed.~   "
28435|NCT02684955|"~     Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans~     outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between~     15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest,~     the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with~     trained resuscitation teams. However, only 5-10% of patients will survive with good~     neurological status. A good quality CPR, a short time before initiation of the resuscitation~     and a short delay before the first defibrillation have been associated with improved~     neurological outcome. Unfortunately it is currently impossible to obtain reliable~     information on the quality of the perfusion and oxygenation of organs during CPR. The~     current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and~     end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with~     probability of ROSC and its value gives no indication of the long-term prognosis nor the~     neurological status.~      Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a~     noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting~     the balance between need and supply of brain oxygenation. This technique has been recently~     used in cardiac arrest showing a possible association between rSO2 measured during CPR and~     the occurrence of ROSC or survival. The quantitative measurement of the pupillary light~     reaction has been described to predict neurological outcome in the hospital for patient~     successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility~     study has shown that its use was also possible during CPR in the pre-hospital setting.~      The investigators aim to study a composite prognostic factor combining quantitative rSO2 and~     automated pupillometry measured during CPR. The investigators hypothesized that the rate of~     survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30%~     for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR~     .~   "
28436|NCT02684942|"~     Purpose: To compare the pain level and quality of life of the two sedation regimens~     consisting of diazepam in combination with meperidine or fentanyl.~      Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected~     brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed~     consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according~     to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were~     collected. Patients and all brachytherapy staffs directly involved with the procedure were~     blinded about the drug used.~   "
28437|NCT02684929|"~     Branched-chain amino acids (BCAA) belong among nutrients strongly linked with insulin~     sensitivity (IS) measures. Their exact effect on IS appears to be dependent on various~     conditions that remain to be better defined . The aim of the current study was to~     investigate effects of chronic increase of BCAA intake on IS in two groups of healthy~     subjects differing in their basal consumption of BCAA, i.e. vegans and omnivores.~     Interventional trial was designed where vegans and omnivores were separately interveined~     with 15 (women) or 20 (men) grams of BCAA daily. Examinations of participants are intended~     to be done at baseline, after the intervention and wash-out period. Examinations~     (anthropometry, hyperinsulinaemic-euglycaemic clamp, arginine test) and blood analyses will~     be performed at baseline, after the intervention and after a 6 month wash-out period.~     Samples of subcutaneous abdominal adipose tissue (AT) and skeletal muscle (SM, vastus~     lateralis) obtained before and after the intervention will be used for various analyses~     (mRNA levels of selected metabolic markers, fatty acid composition, mitochondrial activity).~   "
28438|NCT02684916|"~     The primary aim of the study is to assess the effectiveness of chiropractic manipulation~     treatment versus placebo treatment in children suffering from headache for more than six~     months.~   "
28439|NCT02684903|"~     This is a randomized, controlled trial of Parent-Child Interaction Therapy (PCIT) designed~     to test the effects of PCIT on self-regulation and behavior in child maltreating (CM)~     parents and their elementary-school children. Two hundred-fifty (250) maltreating mothers~     and their children (age 5-8 years) will be drawn from Child Protective Services and~     randomized to the PCIT intervention or a control condition (services as usual). Key~     contextual risk factors will be assessed, including cumulative risk, parent mental health,~     and parent substance use. A multirater, multimethod approach to assessment will include~     neural (EEG/ERP), physiological (ECG), behavioral, and self-report measures of~     self-regulation in CM mothers and their children, as well as standard measures of parenting~     skills and children's behavior outcomes. Families will be followed at 6 months for~     self-regulation, parenting, and child behavioral outcomes, and to 1 year for CM recidivism.~     Findings from this proposed study are expected to have significant implications for~     optimizing CM parenting interventions by (a) determining the sensitivity of CM parent and~     child neurobehavioral self-regulation systems to intervention, and (b) identifying~     individual differences in self-regulation that mediate and moderate response to intervention~     and long-term maintenance of gains.~   "
28440|NCT02684890|"~     Tinnitus may affect the ability of patients to detect emotions in spoken language. This~     study will compare this ability between tinnitus patients and non-tinnitus patients.~   "
28441|NCT02684877|"~     The investigators contacted consecutive adult patients admitted to intensive care unit (ICU)~     and mechanically ventilated for at least 72 hours to invite them to an interview at~     hospital. The investigators administered Mini Mental Status Examination, Functional~     Assessment of Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36~     questionnaires to the consenting patients.~   "
28443|NCT02684851|"~     The purpose of this study is to determine if patients undergoing acetabular ORIF (open~     reduction with internal fixation) who receive tranexamic acid have a reduced risk of~     allogenic blood transfusion, perioperative blood loss, wound complication and higher risk~     for thromboembolic events compared to patients who receive placebo. Investigators want to~     determine the cost-effectiveness related to allogenic blood transfusion as a blood loss~     management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic~     surgery carries with it a significant risk for blood loss. Current management of~     perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood~     transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse~     reactions. There have been significant efforts to reduce the use of allogenic blood~     transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been~     used in management of blood during surgery. In order to determine the impact of tranexamic~     acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will~     conduct a prospective randomized study. Patients undergoing acetabular surgery will be~     screened for this study. Patients will be then randomized to placebo or tranexamic acid~     which will be administered during and after surgery. The following data will be collected:~     patient characteristics, surgery information, blood loss, blood transfusions, wound~     complication within 30 days of surgery, and cost.~   "
28444|NCT02684838|"~     This is a prospective, observational registry in patients who have been prescribed Gliadel~     Wafer by the physician as part of usual care.~   "
28445|NCT02684825|"~     The primary objective of this study is to evaluate whether, in patients with first-ever~     atherothrombotic or lacunar stroke without any previous history of atrial fibrillation~     (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or~     symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder~     (ILR) during the first 12 months of observation is higher than the detection by using a~     standard cardiac monitoring (physical exam, 12-lead electrocardiogram [ECG] at baseline, 3,~     6, and 12 months and Holter ECG at 3 months) in the same period of time.~   "
28446|NCT02684812|"~     This is a multicenter, prospective, randomized, open-label trial with blinded endpoint~     (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by~     computed tomography (CT) within 24 hours after the onset of headache, will be randomly~     assigned to the treatment group or the control group. Patients in the treatment group will~     receive standard treatment with the addition of a bolus of TXA (1 g intravenously)~     immediately after randomization, followed by continuous infusion of 1 g per 8 hours until~     the start of aneurysm treatment, or a maximum of 24 hours after the start of medication.~     Patients in the control group will receive standard treatment without TXA. The primary~     outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the~     modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a~     trial nurse blinded for treatment allocation.~   "
28447|NCT02684799|"~     This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess~     the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC~   "
28448|NCT02684786|"~     Pulmonary hypertension Group 2 (PH 2) associated with left-sided heart disease is relatively~     common, is associated with a poor prognosis, and unfortunately there are no proven medical~     treatments beyond attempts at correcting the left sided heart disease. Many PH 2 patients~     have evidence of active constriction of blood vessels from increased nerve traffic. Use of~     agents or procedures which produce a reversible chemical blockage of this nerve traffic have~     not been systematically tested in PH 2. The investigators will test whether acute~     interruption of sympathetic nervous system tone, which local anesthetic block of the~     stellate ganglion in the neck, will improve PH2, and also test whether the high blood~     pressure drug reserpine, which blocks sympathetic nerve activity, will do so during a one~     month trial period.~   "
28449|NCT02684773|"~     Background: In 2010, approximately 39000 Canadians had end-stage renal disease (ESRD), and~     the prevalence rate of dialysis has increased by 189% over the past 2 decades. The annual~     mortality rate remains high at ~15%, and cardiovascular events are the leading cause of~     death. Intensification of conventional dialysis schedules has been the major focus in recent~     years. Currently, most Canadian dialysis patients receive conventional in-center~     hemodialysis (CHD), which is administered as a 3-4 hour session 3/week. Recent research has~     focused on home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6~     nights/week), which may have substantial cardiovascular benefits, including regression of~     left ventricular (LV) hypertrophy, improved LV ejection fraction and enhanced blood pressure~     control. Nevertheless, this dialysis modality is only feasible in a highly selected minority~     of ESRD patients who can self-manage their dialysis treatment at home. In-center nocturnal~     hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3nights/week,~     represents a promising and practical alternative for many dialysis patients. In a Canadian~     Institutes for Health Research (CIHR) supported cohort study, the investigators have~     recruited 67 patients and have completed 1-year follow-up. There is a compelling need for~     longer-term follow-up, since all the published randomized controlled trials are of short~     duration (6-12 months), while renal replacement therapy is a life-long treatment.~     Furthermore, the observed large variability of cardiac remodeling in individual ESRD~     patients remains poorly understood. Therefore, the current study is an extended follow-up~     phase (5 years from enrollment) on the completed 1-year follow-up period and the purpose of~     this study is to objectively evaluate the long-term effects of more intensified hemodialysis~     treatment which the INHD modality offers.~      Need for Long-term and Generalizable Data: In contrast to the seminal Alberta trial which~     showed a significant LV mass reduction with home nocturnal hemodialysis, the recently~     reported Frequent Hemodialysis Network Nocturnal Trial demonstrated only a trend toward~     reduction in LV mass. It is likely that the highly selected participants, inadequate trial~     power and duration (12 months) account for the observed results. Currently, it is unknown~     whether INHD, which is less intensive but more feasible for most ESRD patients, is~     associated with similar cardiovascular benefits in the long term.~      Objective:~        1. To determine the long-term effects of INHD on (i) LV mass; (ii) global and regional LV~          systolic and diastolic function; (iii) myocardial tissue characteristics; (iv) left~          atrial structure and function; (v) selected cardiovascular biomarkers in ESRD patients.~        2. To examine the determinants and mechanisms of cardiac remodeling in ESRD~      Hypothesis: Conversion to INHD is associated with sustained improvements in cardiovascular~     structure and function, as compared to conventional hemodialysis (CHD) in patients with~     end-stage renal disease (ESRD).~      Study Design and Population: This will be a 2-centre, prospective, longitudinal cohort study~     of 67 adult ESRD patients (INHD subjects and CHD controls) enrolled in the original study.~     All eligible participants who provide consent will undergo cardiac Magnetic Resonance~     Imaging (MRI) examination and bloodwork at 5 years since enrollment in the study. Other~     follow-up procedures include the following -electrocardiogram, transthoracic echocardiogram,~     ambulatory blood pressure monitoring, lateral x-ray of the aorta, and completion of~     questionnaires.~      Outcome: The primary endpoint is the change in LV mass over 5 years, as measured by cardiac~     MRI. Secondary endpoints include LV size, global and regional diastolic and systolic~     function, left atrial size and function, changes in myocardial tissue characteristics, blood~     pressure, serum troponin, norepinephrine, Brain Natriuretic Peptide (BNP), high sensitivity~     C-Reactive Protein (hsCRP), interleukin-6, matrix metalloproteinases, fibroblast growth~     factor-23, fetuin-A, transforming growth factor-beta, connective tissue growth factor,~     clinical events, and quality of life.~      Significance: The provision of an enhanced dialysis regimen has emerged as the most~     promising avenue through which to modify the dismal cardiovascular outcomes in patients~     receiving chronic hemodialysis. INHD represents a means of administering such therapy to a~     broad spectrum of dialysis patients for whom home therapies would not be feasible. This~     study will be the first to precisely define the long-term cardiac effects of intensified~     dialysis and to elucidate the mechanisms of cardiac remodeling in ESRD, using cardiac MRI~     and other novel biomarkers. These important observational findings may have a major impact~     on the optimal management and outcome of ESRD patients in the real world.~   "
28450|NCT02684760|"~     PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will~     test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral~     solution formulation under fasting conditions and the effect of a high fat meal on the~     bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and~     tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed~     under fasting and fed conditions.~   "
28451|NCT02684747|"~     A total of 40 subjects will be recruited for participation in this study. 20 subjects (10~     males and 10 females) will be randomized to the active group (those receiving re-infusion of~     autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the~     placebo group (receiving NS infusion).~   "
28452|NCT02684734|"~     Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate~     the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and~     timely detection of active CMV infection or disease with appropriate anti-viral therapy may~     reduce complications associated with acute UC flare. Limited information is available on the~     presence of colonic CMV infection in patients with quiescent ulcerative colitis. Prospective~     studies on factors associated with reactivation of CMV infection during active UC flare and~     its impact on disease progression are lacking.~      The hypothesis of this study are as follows: 1) CMV infection is prevalent in patients with~     ulcerative colitis irrespective of disease severity; 2) The degree of immunosuppression~     directly impacts CMV infection status in patients with ulcerative colitis~   "
28453|NCT02684721|"~     In a randomised design the study aims to investigate whether an intervention of 8 weeks~     home-based exercise in addition to usual care can positively influence the physical~     capacity, quality of life, sick leave and use of psychoactive drugs in patients medically~     treated for pulmonary embolism.~   "
28454|NCT02684708|"~     The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with~     the aims to reduce the indication for radiotherapy in newly diagnosed patients with~     classical Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy~     intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to~     compensate for reduction in radiotherapy.~   "
28455|NCT02684695|"~     This observational study aims to develop and validate quantitative magnetic resonance~     imaging biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA).~     This includes patients with enthesitis-related arthritis (ERA).~   "
28458|NCT02684656|"~     The health care burden of CKD is substantial and growing with 10-15% of the population~     affected in both developed and developing countries. It is well established that CKD is~     associated with systemic inflammation, which promotes cardiovascular disease and body~     wasting. However, causal therapies to treat systemic inflammation, and treat its adverse~     consequences remain sparse. As kidney function declines in all forms of CKD, oxalate levels~     increase in the plasma, leading to increased systemic exposure to oxalate and consequent~     tissue injury. Work from the investigators has shown that elevated plasma oxalate levels~     activate the NLRP3 inflammasome which in turn leads to the processing and release of~     cytokines. The investigators seek to test the hypothesis that oxalate contributes to the~     systemic inflammation observed in patients with end-stage renal disease (ESRD). The~     investigators plan to define the association between plasma oxalate levels and signs of~     systemic inflammation in patients on hemodialysis. In a second step the investigators will~     examine whether hemodiafiltration lowers plasma oxalate more efficiently than hemodialysis~     and reduces signs of systemic inflammation. Confirmation of the hypothesis may lead to the~     identification of oxalate as a novel therapeutic target for interventional trials aimed at~     reducing plasma oxalate in patients with ESRD.~   "
28459|NCT02684643|"~     This study is designed to study and compare the efficacy and cost-effectiveness of~     individualized phosphate-lowering therapy in comparison with regular guideline-recommended~     therapy.~   "
28460|NCT02684630|"~     The purpose of this study is to optimize collected platelet yields in single and double~     platelet collections, while maintaining donor postplatelet count of >100,000/µL.~   "
28461|NCT02684617|"~     This is a non-randomized, open-label study evaluating the safety and efficacy of~     pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of~     relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or~     diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.~      During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting~     Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7~     mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg~     followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose~     Evaluation Phase, approximately 30 participants each will be enrolled in rrCLL, rrMM, or~     DLBCL cohorts during the Signal Detection phase. For each disease type objective response~     rate (ORR) will be determined by disease specific criteria.~   "
28462|NCT02684604|"~     Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing~     that with it's prevalence in fertile women.~   "
28463|NCT02684591|"~     A subset of patients with NAFLD that have not been extensively studied are those infected~     with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for~     NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients~     with NAFLD and there are no approved treatment options. We plan to conduct a randomized,~     double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of~     Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given~     over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and~     accurate magnetic resonance imaging (MRI)-based technique.~   "
28464|NCT02684578|"~     The purpose of this study is to determine whether metformin, an FDA-approved drug for the~     treatment of type II diabetes, is a safe and effective treatment to decrease the progression~     of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD).~   "
28465|NCT02684565|"~     Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on~     metabolism have been established and therefore warrants further investigation. In the~     preliminary study, the investigators found that BCAAs enhanced glucose metabolism in lean~     mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased~     adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But~     in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue.~      This study will examine 10 obese subjects with pre-diabetes and examine the effects of~     taking BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride~     levels and will have an oral glucose tolerance test on repeated occasions to see if any~     changes are noted in their glucose regulation.~   "
28466|NCT02684552|"~     Patients with cystic fibrosis older than 18 years will performance a Bruce test with non~     invasive ventilation (once) after 30 minutes they perform the same test with oxygen~     supplementation.~      Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.~   "
28467|NCT02684539|"~     syncope prediction on tilt table~   "
28468|NCT02684526|"~     To examine the quality of liver images produced when the contrast agent Eovist is used~     during MRI.~   "
28469|NCT02684513|"~     For more than 15 years, traditional fasting regimens prior to scheduled surgeries have been~     called into question, yet prolonged preoperative fasting remains common practice. While~     prolonged fasting is aimed at reducing the risk of pulmonary aspiration, prolonged fasting~     is uncomfortable, has an inconsistent effect on gastric volumes and acidity and may lead to~     dehydration without a clear reduction in the incidence of aspiration. Fasting by itself~     decreases hepatic glycogen stores, induces a state of insulin resistance and impairs~     cardiovascular function. Yet, prolonged preoperative fasting remains common.~      Preoperative oral carbohydrate (CHO) consumption improves insulin sensitivity and decreases~     the time to return of gut function without increasing gastric volumes or acidity compared to~     other clear liquids and fasting. Previous work has shown oral CHO consumption improves~     patient well-being to a greater degree than placebo drink (water or flavored water) and~     fasted controls. Oral CHO also outperforms a similar volume of intravenous glucose~     supplementation. These benefits have reduced hospital stays in a variety of surgical models~     by as much as 20%. Further, preoperative CHO supplementation improved postoperative patient~     hunger, thirst, anxiety, fatigue and nausea.~      The purpose of this research study is to determine if drinking a high carbohydrate beverage~     before cesarean section surgery can improve patient well-being, compared to patients who~     drink a low carbohydrate beverage or fast before surgery.~   "
28470|NCT02684500|"~     The purpose of this research study is to determine if the diameter and flow of the superior~     mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing~     hypertensive therapy for cerebral artery vasospasm are effected enough to justify~     withholding enteral nutrition.~   "
28471|NCT02684487|"~     Sepsis is a clinical entity that complicates infection. Without early recognition and timely~     management, it can rapidly progress to severe sepsis, septic shock, and culminate in~     multiple organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D~     status, yet little is known about the impact of vitamin D3 (vitD3) supplementation in this~     patient population. As such, the investigators propose a randomized, double-blinded,~     placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin~     D status, as an adjunct to established treatment guidelines, will improve clinical outcomes~     and measurably alter immune profile in patients with severe sepsis.~   "
28472|NCT02684474|"~     The purpose of this protocol is to provide treatment with HBOC-201 to patients with~     life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201~     [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood~     transfusions in severely anemic patients needing a way to enhance tissue oxygenation.~     HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified~     lactated Ringer's solution, and does not require blood compatibility.~   "
28473|NCT02684461|"~     The purpose of this research study is to test the effectiveness of three treatment arms that~     are designed to improve survival in patients with non-small cell lung cancer. Eligible~     subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy,~     or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus~     immunotherapy.~   "
28474|NCT02684448|"~     This multi-center, retrospective data collection study will evaluate the feasibility, safety~     and performance of the da Vinci® surgical system for patients who have undergone~     robotic-assisted inguinal hernia repair, as well as provide information about the learning~     curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.~      In addition, this retrospective data collection study will evaluate the perioperative~     outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative~     outcomes with those associated with open hernia repair by the same participating surgeon.~   "
28475|NCT02684435|"~     The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney~     malignancies~   "
28476|NCT02684422|"~     This study aims to examine features of MRSA that are associated with chronic MRSA infection~     and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate~     sputum and complete CF symptom diaries both at beginning and end of IV therapy.~   "
28477|NCT02684409|"~     This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy~     adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity~     patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will~     remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is~     obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments~     will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion~     evaluations, skin irritation evaluations, and vital signs.~   "
28478|NCT02684396|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose~     levels in healthy participants.~   "
28479|NCT02684383|"~     Infection with dengue viruses is the leading cause of hospitalization and death in children~     in many tropical Asian countries, and the development of a dengue vaccine is a top health~     priority. This study will evaluate the safety and immunogenicity of a live attenuated~     monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous~     flavivirus infection.~   "
28480|NCT02684370|"~     This is a randomized double blind, double dummy, placebo and active comparator controlled,~     parallel design study that is being performed to assess the safety and efficacy of BI~     655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to~     severe chronic plaque psoriasis in adult patients.~   "
28481|NCT02684357|"~     This is a randomized double blind, double dummy, placebo and active comparator controlled,~     parallel design study that is being performed to assess the safety and efficacy of BI 655066~     to support registration for the treatment of moderate to severe chronic plaque psoriasis in~     adult patients.~   "
28482|NCT02684344|"~     This randomized open-label study will be comprised of 2 cohorts: one control group and one~     treatment group. The trial will be conducted as an open label randomized trial to evaluate~     the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study~     will include pre- and post-surgical evaluations of patients including symptoms of urinary~     retention and any adverse effects contributable to the study medication.~   "
28483|NCT02684331|"~     The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients~     (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes~     outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac~     magnetic resonance imaging (CMR), clinical examination and will be asked to fill out~     questionnaires.~      This study project sets out to answer the following hypotheses:~        1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using~          CMR, the investigators wish to measure left ventricle peak filling rate and passive~          atrial emptying fraction as a measure of cardiac diastolic function. The investigators~          hypothesize that classic T2DM markers such as levels of urinary albumin excretion,~          retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM~          duration, etc. are associated with pathological findings by CMR.~        2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by~          gadolinium contrast CMR. The investigators hypothesize that the classic markers and~          risk factors mentioned above, are associated with left ventricle myocardial~          hypoperfusion as determined by gadolinium contrast CMR.~   "
28484|NCT02684318|"~     Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with~     olaparib in patients with advanced solid tumors.~   "
28496|NCT02684162|"~     The goal of this clinical research study is to learn if giving donor lymphocyte cells and~     SGI-110 will help control acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)~     in patients who have had an allogeneic stem cell transplant (using someone else's stem~     cells) and have relapsed. The safety of this treatment will also be studied.~   "
28497|NCT02684149|"~     Study objective is to assess the interest of the relational touch before an arterial~     puncture to reduce pain on patient in intensive care unit.~   "
28485|NCT02684305|"~     Induction of labor is one of the most common obstetrical medical procedures performed today.~     Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is~     undertaken for various maternal and fetal indications and spans 20% of deliveries today.~        1. During the past years there has been an additional rise due to elective inductions~        2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks~          of induced delivery, particularly those associated with post-term pregnancy, rupture of~          membranes, oligohydramnios and additional fetal and maternal conditions that pose risks~          to mother and fetus.~      In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less)~     sequential induction with more than one agent is necessary. To date, no trial has compared~     the optimal subsequent ripening method after the preliminary use of dinoprostone~     (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of~     subsequent induction in women admitted for induction of labor with Bishop score <7 or less~     24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of~     routine induction of labor will be compared: An additional Propess induction for another 24~     hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.~   "
28486|NCT02684292|"~     The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of~     participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be~     randomized to receive either pembrolizumab or brentuximab vedotin for up to 35 three-week~     cycles of treatment.~      The primary hypotheses of this study are that treatment with pembrolizumab prolongs~     Progression Free Survival (PFS) and Overall Survival (OS) in participants with relapsed or~     refractory Classical Hodgkin Lymphoma compared to treatment with brentuximab vedotin.~   "
28487|NCT02684279|"~     Binge Eating Disorder Extension Study.~   "
28488|NCT02684266|"~     SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this~     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390~     in Chinese advanced solid tumor patients by using a 3+3 dose escalation.Preliminary~     efficacy will be also investigated in this study.~   "
28489|NCT02684253|"~     Nivolumab is an antibody (a type of human protein) that is designed to boost your body's~     immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab~     has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung~     cancer. It is currently under study for the treatment of head and neck squamous cell cancer.~   "
28490|NCT02684240|"~     This research is being done to determine if Nitazoxanide (NTZ) will cause a significant~     decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The~     study is being conducted at the GHESKIO Centers in Port au Prince Haiti~   "
28491|NCT02684227|"~     This clinical research study has two parts: a safety lead-in and Phase 2.~      The goal of the safety lead-in is to find the highest tolerable dose of enzalutamide in~     combination with carboplatin and paclitaxel that can be given to patients with recurrent or~     advanced endometrial cancer.~      The goal of Phase 2 of this study is to learn if the study drug combination can help to~     control recurrent or advanced endometrial cancer.~      The safety of the drug combination will be studied in both parts of the study.~   "
28492|NCT02684214|"~     The ability of Prevention Plus to improve weight status when delivered by primary care~     providers is unknown, and the influence of household food security status as a moderator in~     the treatment of childhood obesity has never been examined. Thus, the investigators will~     conduct a randomized controlled trial (RCT) examining Prevention Plus delivered by CHS~     primary care providers on child zBMI in underserved children receiving their primary care at~     CHS who are overweight and obese, and test the moderating effect of household food security~     status on Prevention Plus delivered with and without caretaker goals~   "
28493|NCT02684201|"~     Individuals with upper-limb amputation usually have intact nerves within the residual limb,~     and studies have demonstrated that electrical stimulation of those nerves can produce~     sensations that appear to emanate from the amputated limb. In this study, investigators will~     examine the sensations that are produced by electrical stimulation of these nerves at the~     location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to~     treat intractable back and limb pain, and the procedure includes a test phase in which~     electrodes are temporarily placed under the skin near the spinal cord and removed at the end~     of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the~     upper back and neck, and stimulation will be applied over the course of multiple testing~     sessions, lasting less than 30 days. The electrodes will be removed at the last day of~     testing. During each testing session, electrical stimulation will be applied through the~     electrodes and a series of tests will be performed to determine the types of sensations~     produced by stimulation. In addition to producing meaningful sensations with electrical~     stimulation, this study will also test the effect of stimulation on phantom limb sensations~     and phantom limb pain.~   "
28494|NCT02684188|"~     Residents of rural and frontier counties experience significant disparities in health care~     access and outcomes when compared to their urban counterparts. The organization of health~     care delivery contributes significantly to these disparities. For rural residents with~     multiple chronic conditions, transitioning along the continuum of care, between systems of~     treatment and support, and between dispersed locations present significant challenges. One~     critical challenge involves hospitalization for treatment because it requires travel to~     locations at a significant distance from home and disrupts personal and family routines. The~     transition back home is also problematic because discharge planning does not adequately~     account for limited access to care in rural areas. Indeed, discharge planning has been~     recently described as a black hole; fragmented and uncoordinated, and contributing to poor~     outcomes and patient dissatisfaction. The specific aim of this research is to ascertain~     rural patients' actual experience of the discharge planning process and to involve patients~     and rural providers in designing and testing a contextually appropriate rural options~     discharge model (ROADMAP) that improves patient outcomes and reduces re-hospitalizations.~   "
28495|NCT02684175|"~     The objective of this study is to compare remote and in-person audiological cochlear implant~     candidacy evaluations (including audiological (hearing) testing and counseling sessions) in~     a rural Appalachian region.~   "
28498|NCT02684136|"~     This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia~     co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.~   "
28499|NCT02684123|"~     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can~     fall out on the scalp or elsewhere on the face and body.~      Alopecia areata is an autoimmune skin disease, which means that the immune system is~     recognizing the hair follicles as foreign and attacking them, causing round patches of hair~     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss~     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any~     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs~     in males and females of all ages, and is a highly unpredictable condition that tends to~     recur. Alopecia areata can cause significant distress to both patients and their families.~      In this study, the aim to assess the effects of a new treatment called apremilast in~     patients with alopecia areata. A total of 30 patients will be included in the study, which~     will run for a total of 52 weeks.~   "
28500|NCT02684097|"~     The purpose of this study is to assess whether tralokinumab can be a helpful treatment for~     alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a~     total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp.~     Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic~     dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either~     receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.~     Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be~     randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous~     injection every 2 weeks for 24 weeks.~   "
28501|NCT02684084|"~     This is a 24-week, prospective, multi-center, open-label, randomized, investigator-initiated~     pilot study to explore the effects of RBZ (0.5 mg) plus DEX implant (0.7 mg) PRN combination~     therapy (n = 30) vs. DEX implant PRN monotherapy (n = 30) in pseudophakic eyes with~     center-involved DME that have demonstrated prior incomplete response to 3-6 anti-VEGF~     treatments.~   "
28502|NCT02684071|"~     The purpose of this research study is to test an experimental treatment method for recurrent~     or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and~     chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that~     their use by themselves or together has not been approved by the U.S. Food and Drug~     Administration for this usage.~   "
28503|NCT02684058|"~     The purpose of this study is to investigate the activity of dabrafenib in children and~     adolescent patients with BRAF V600 mutation positive relapsed or refractory high grade~     glioma.~   "
28504|NCT02684045|"~     The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE~     in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.~   "
28505|NCT02684032|"~     This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have~     a dose escalation to identify the maximum tolerated dose (MTD) of the combination of~     gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and~     expansion to estimate the objective response rate (OR) of the combination of gedatolisib~     plus palbociclib/letrozole or palbociclib/fulvestrant.~   "
28506|NCT02684019|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic~     procedure. It is performed in remote locations under a continuum of anesthetic depth,~     ranging from conscious to deep sedation leading to general anesthesia.~      Propofol sedation for (ERCP) procedures is the most popular current technique that has~     generated controversy in the medical field. Propofol can be safely administered because of~     its shorter half-life which results in a shorter recovery time than conventional sedation~     (opioid and/or benzodiazepine) that makes it widely used for sedation in many~     gastrointestinal procedures including ERCP. However, because of its narrow therapeutic~     window, the level of conscious sedation can easily go deeper from moderately deep sedation~     to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and~     apnea. Depth of sedation could be estimated better when target effect concentration of~     propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a~     specific range ensures additional safety during the procedure. Scores between 60-80 have~     been recommended for sedation. Propofol requirement can be reduced with addition of~     adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have~     analgesic properties with opioid and anesthetic sparing effects, without clinically~     significant respiratory depression.~      Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic~     properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it~     reduced their requirements intraoperatively and can help supplement analgesia~     postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia~     for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .~      Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel~     blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal~     intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology~     patients .~      Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during~     ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost~     and complications together with more patient and doctor satisfaction in addition to better~     patient outcome.~   "
28507|NCT02684006|"~     This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab~     in combination with axitinib and of sunitinib monotherapy, administered as first-line~     treatment, in patients with advanced renal cell carcinoma~   "
28508|NCT02683993|"~     Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible~     ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part~     of the study, using the study device. These subjects will be randomized into stone breaking~     treatment or stone dusting.~   "
28509|NCT02683980|"~     Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for~     surgery will undergo a single treatment for ablation of the prostate using the study~     device.Follow up visits are scheduled for the day of release from the hospital and at 1 and~     3 months post procedure.~      The primary objective of this study is to explore Vaporization efficacy and safety when~     treating PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with~     recommended settings.~   "
28510|NCT02683967|"~     The trial aims to investigate whether acupuncture has an effect in increasing clinical~     pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing~     IVF treatment.~   "
28511|NCT02683954|"~     The association between endometriosis, obesity and nesfatin1.~   "
28561|NCT02683291|"~     There is no consensus on the best immunosuppressive regimen in elderly people. The aim of~     this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in~     elderly kidney transplant recipients. The investigators will conduct a single-center~     prospective randomized study comparing the combination of tacrolimus with sirolimus at~     reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate~     (tacrolimus + mycophenolate group). The investigators will include all kidney transplant~     patients over 60 years of age. The investigators will evaluate estimated glomerular~     filtration rate and incidence of cytomegalovirus in 12 month follow-up.~   "
28512|NCT02683941|"~     This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the~     efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of~     well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs This~     study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Extension~     Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Extension~     Phase will consist of two periods: Treatment Period and Follow-Up Period.~      The primary objective will be to compare the antitumour efficacy of Lanreotide Autogel/Depot~     120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, in terms~     of progression free survival (PFS), measured by central review using Response Evaluation~     Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with~     unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine~     tumours~   "
28513|NCT02683928|"~     The purpose of this study is to determine the effect of GBR 830 on biomarkers in AD/ eczema~     to enable further studies in this indication.~   "
28514|NCT02683915|"~     This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term~     and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of~     serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.~   "
28515|NCT02683902|"~     To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo~     associated with a reduced caloric diet on weight loss, glycemic control and regulators of~     hunger and satiety in overweight or obese subjects with different degrees of glucose~     tolerance, submitted to hypocaloric diet.~   "
28516|NCT02683889|"~     This study will evaluate the use of Acthar in patients to undergo renal transplantation and~     will measure the rate of FSGS recurrence.~   "
28517|NCT02683876|"~     The purpose of this study is to identify metabolic signatures associated with malodor~     conditions. The investigators will perform state-of-the art metabolomics tests and~     bioinformatic data mining to explore if conditions leading to malodor can be screened by~     metabolomic profiling of urine samples.~   "
28518|NCT02683863|"~     The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl~     fumarate) its main bioactive metabolite, is capable of entering the central nervous system~     in SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or~     the amount of study drug in blood) will be tested to compare with PK samples, the amount of~     study drug, in spinal fluid (CSF).~   "
28519|NCT02683850|"~     This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™~     soft gel supplement for four weeks will increase the quality of life in adults with chronic~     pain.~   "
28520|NCT02683837|"~     The aim of this prospective randomized study is to evaluate the impact of peroperative~     pupillometry monitoring on per and post-operative opioid consumption in pediatric~     anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the~     intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In~     the other group, remifentanil infusion rate is guided according to hemodynamic data.~   "
28521|NCT02683824|"~     This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 positron~     emission tomography (PET)/computed tomography (CT) in measuring response in patients with~     pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta~     [18F]-R01-MG-F2, are a family of membrane receptors that are overexpressed and attaches to~     various proteins which sense and respond to contact events that occur at the cell surface~     and may improve early detection of pancreatic cancer and improve patient selection for~     anti-integrin alpha-v-beta 6 therapy.~   "
28522|NCT02683811|"~     This study evaluates the short- and long-term effects on psychological wellbeing and~     health-related behaviours of the updated version of a universal school-based program called~     Diario della Salute (DDS-2) in Italian students aged 11-13 years.~   "
28523|NCT02683798|"~     A study to determine the effectiveness of two weight loss maintenance interventions in~     Counterweight Plus, a structured weight management programme.~   "
28524|NCT02683785|"~     This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel~     group study with the primary objective to assess the efficacy potential of GSK3196165 on~     pain, in subjects with active inflammatory hand osteoarthritis (HOA).~      Approximately 40 subjects will be enrolled into the study, following a screening period of~     up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period~     completing at Week 22. At least 40 subjects will be randomized across the two treatment~     arms, to either placebo or GSK3196165 in a 1:1 ratio.~   "
28525|NCT02683759|"~     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an~     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of~     treatment options are directed at attempting to control the chronic inflammation and~     prolonging remission of clinical symptoms. Several studies have proven that curcumin has~     well-established anti-inflammatory properties. However, curcumin has poor bioavailability~     and prior studies have needed to use high concentrations in order to study the efficacy of~     the product. The investigators propose that a bio-enhanced preparation of curcumin will~     require a lower dosage to reach and affect its target tissue and will subsequently produce~     less adverse side effects.~   "
28558|NCT02683330|"~     Psychological difficulties, especially depression and anxiety are the most prevalent~     non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as~     effective in PD. Mindfulness courses have received increased popularity and recognition as~     an effective way to manage emotional states, and there is ever growing findings of the~     effectiveness of mindfulness courses for people with long-term medical conditions. Two small~     pilot studies have indicated that mindfulness courses can be helpful for people with PD in~     improving symptoms of depression, language functioning and motor symptoms. The investigators~     propose to deliver these courses remotely, through Skype video conferences, to make it more~     accessible for people with mobility limitations and people who live in rural areas.~   "
28559|NCT02683317|"~     The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral~     feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.~   "
28562|NCT02683278|"~     This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful~     awareness and acceptance treatment (M), and arthritis education as an active control~     condition (E) on mental and physical health outcomes among adults with chronic pain due to~     fibromyalgia (FM).~   "
28526|NCT02683746|"~     This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose,~     study of 26 weeks duration to evaluate the efficacy, safety, tolerability and~     pharmacodynamic response of albiglutide liquid drug product relative to the commercial~     lyophilized drug product. The study will specifically evaluate the potential for~     immunogenicity (example [e.g.] incidences of anti-drug antibodies [ADA]) and injection site~     reactions (ISRs).~      Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long~     half-life to permit once a week injection. Currently, lyophilized albiglutide and the~     diluent are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring~     reconstitution prior to use. A liquid formulation of albiglutide will enable the~     commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an~     auto-injector.~      The primary hypothesis of this study is to test that liquid drug product will provide~     glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized~     drug product for a period of 26 weeks of treatment in subjects with T2DM.~      This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and~     for those subjects not entering the extension study a follow-up period (8 weeks).~     Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active~     liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI);~     or, Albiglutide lyophilized DCC PI plus Placebo LAI.~   "
28527|NCT02683733|"~     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an~     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of~     treatment options are directed at attempting to control the chronic inflammation and~     prolonging remission of clinical symptoms. Several studies have proven that curcumin has~     well-established anti-inflammatory properties. However, curcumin has poor bioavailability~     and prior studies have needed to use high concentrations in order to study the efficacy of~     the product. The investigators propose that a bio-enhanced preparation of curcumin will~     require a lower dosage to reach and affect its target tissue and will subsequently produce~     less adverse side effects.~   "
28528|NCT02683720|"~     ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body~     weight, muscle mass and function in malnourished elderly compared to standard care.~   "
28529|NCT02683707|"~     With potent analgesic properties, perceived hemodynamic benefits and limited alternatives,~     opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting~     peri-procedural pain or nitrate-resistant chest pain. However, large observational studies~     suggest that opiate administration during ACS may result in adverse cardiovascular outcomes.~     Complimenting this, a number of recent mechanistic studies have demonstrated delayed and~     attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition~     endpoints among subjects receiving intravenous morphine. These studies support the~     hypothesis that morphine delays the gastrointestinal absorption of DAPT medications.~     However, no data exist on the impact of intravenous fentanyl, a systemic opioid analgesic~     routinely administered during percutaneous coronary intervention (PCI) procedures, on the~     platelet inhibition effects of DAPT. The investigators hypothesize that, similar to~     morphine, fentanyl administered at the time of PCI will reduce and delay the effect of DAPT~     on platelet function. As such, the primary aim of this study is to test the impact of~     intravenous fentanyl on residual platelet reactivity by randomizing patients undergoing PCI~     to a strategy of peri-procedural benzodiazepine plus non-systemic local analgesia or to the~     current standard of benzodiazepine plus intravenous fentanyl. Given the critical need for~     rapid and robust inhibition of platelet function during PCI, this trial has true potential~     to change clinical practice, particularly if the investigators demonstrate reduced DAPT~     absorption and elevated residual platelet reactivity among patients receiving fentanyl~     during PCI.~   "
28530|NCT02683694|"~     During the last decade optical coherence tomography (OCT) extended the possibilities for in~     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of~     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased~     scanning speed and image-resolution provides more detailed information of microstructures in~     the macula.~      Epiretinal membrane (ERM), pseudomaculaforamen, maculaforamen and vitreomacular traction~     syndrome are disorders involving the posterior pole of the eyeball with consecutive vision~     loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle,~     vitrectomy and membrane peeling is usually performed to remove traction and the ERM.~      Different study groups showed that intraoperative use of SD-OCT is possible and improves the~     Quality of Peeling surgery.~   "
28531|NCT02683681|"~     This is a registry study. This is an observational, non-randomized, open, long-term project~     to collect biological samples (e.g. tissue and blood samples) in addition to clinical~     information and laboratory test results, from end-stage patients who undergo LVAD~     implantation and/or heart transplantation. There are no investigational treatments, drug or~     procedures associated with participation in registry activities.~      Data collection will not immediately influence the course of treatment for any patient.~   "
28532|NCT02683668|"~     The aim of the study is to investigate the effect of tiotropium from different devices on a~     panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients~     with mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18~     micrograms once daily and Tiotropium Respimat 5 micrograms once daily~   "
28533|NCT02683655|"~     The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic~     Esophageal Cancer.~   "
28560|NCT02683304|"~     The main objective of this pilot study is to make a first assessment of the discriminating~     ability of a dosage of S100B protein for differential diagnosis between primary headaches~     and secondary headaches.~      For this, the investigators will compare serum S100B protein between two groups of headache~     patients presenting at the emergency department: 1 group of primary headache patients and 1~     group of secondary headache patients.~      If the difference between the two groups proves potentially discriminating, the~     investigators will seek to determine the discriminating ability of the S100B protein by~     calculating the area under the ROC curve.~      The reference diagnostic will be set at one month across the entire clinical picture and~     imaging by an expert committee composed of a neurologist, a radiologist and an emergency~     physician.~   "
28721|NCT02681211|"~     Patients with migraine headache will be offered the opportunity to participate in this~     randomized study evaluating auricular acupuncture versus standard treatment for migraine~     headaches for patients in the pediatric emergency department (ED).~   "
28534|NCT02683642|"~     Invasive mould infections are emerging causes of morbidity and mortality in ICU patients.~     This is attributed to prolonged ICU stay of critically ill patients with many~     co-morbidities. Modern medicine and multiple intervention make the patients susceptible to~     these prevalent moulds in the environment. In India the high frequency of IMIs in general~     has been attributed to environmental and host factors prevalent in this region. Additionally~     sub-optimal hospital care practice, frequent demolition and construction activities in the~     hospital make the patients susceptible to IMIs. There is no multicentric study available in~     India describing the epidemiology of IMIs in India. However, single center studies have~     reported distinct epidemiology of IMIs in India. High incidence, different spectrum and risk~     factors are possible unique features of IMIs in India.Early diagnosis and optimal therapy~     improve the outcome of these patients. The conventional diagnosis including histopathology~     and culture has limitations. The tests are of low sensitivity and long turnaround time. The~     major challenge is collection of sample from deep tissue. Therefore majority of the patients~     in ICUs of India are managed empirically against invasive fungal diseases. The galactomannan~     test has improved the diagnosis of invasive aspergillosis. However, galactomannan test is~     not well standardized in non-neutropenic patients. Beta-glucan test is used for early~     diagnosis of invasive fungal infections other than mucormycosis. But the test is cumbersome~     for routine laboratories and expensive. Both tests are not available in majority of~     Institutions of India. PCR assay is not standardized and not performed routinely in any~     Institution.~      Due these limitations in diagnosis, there is no uniform management protocol in ICUs of~     India. To develop optimal management protocol, we need to know the epidemiology, the right~     patient to treat, antifungal drug resistance, optimal drug and duration of therapy etc. The~     present study will provide descriptive epidemiology, present status of diagnosis and~     management practiced in India to treat IMIs in ICUs. This will help to find the suitable~     intervention strategies to improve outcome of IMIs in India.This descriptive observational~     prospective study will document the epidemiologic and clinical characteristics, as well as~     treatment and outcome data, of patients with IMIs in ICUs in India over one year.~   "
28535|NCT02683629|"~     To assess the safety of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed~     over the duration of the study, by monitoring the occurrence of adverse events and serious~     adverse events, including clinical and laboratory evidence of xenogeneic infection in~     transplant recipients and their partners/close contacts. Subsequent safety follow-up will~     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.~      To assess the efficacy of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease. This~     will be quantified by testing the secondary endpoints of the trial as described below (see~     Endpoints/Outcome Measures).~   "
28536|NCT02683616|"~     Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80%~     of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the~     development of glucose intolerance and T2DM. The project is targeting the gap in providing~     effective treatment of metabolic impairments associated with OSA, particularly T2DM. In~     contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure)~     on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are~     disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP~     treatment, as investigators suggested recently. Clearly, the search for additional~     treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated~     levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM~     development. The aim of the study is to target adipose tissue and muscle dysfunction leading~     to elevated FFA and develop thus novel pharmacological treatments based on lipolysis~     inhibition and stimulation of FFA oxidation.~   "
28537|NCT02683603|"~     the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR)~     gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit~     (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side~     effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be~     tried. Several recent data emphasize the interest of inhaled route. The investigators~     purpose was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in~     ventilator associated pneumonia.~   "
28538|NCT02683590|"~     For the replacement of the sternum, there is no consensus regarding the most appropriate and~     most effective physiologically material. The use of ceramic implant offers significant~     operational time saving and biocompatibility coupled with the strength of the material allow~     us to realize a more natural operation, limiting the risk of infection and rejection.~      Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic~     implant on the respiratory capacity at 3 months post surgery.~   "
28539|NCT02683577|"~     The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a~     single dose of telotristat etiprate in subjects with various stages of hepatic impairment~     compared to healthy control subjects.~   "
28540|NCT02683564|"~     This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3~     clinical study to evaluate the efficacy, safety and immunogenicity of BOW015~     (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA)~     despite Methotrexate (MTX) therapy.~   "
28541|NCT02683551|"~     Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before~     and after operation.~   "
28542|NCT02683538|"~     The purpose of this study is to evaluate the clinical feasibility and short-term outcome of~     switching monopolar RFA using a separable cluster electrode in patients with primary and~     secondary liver malignancies.~   "
28543|NCT02683525|"~     Primary Objective~      Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft~     Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic~     hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD~     prophylaxis.~      Secondary Objectives~      The following descriptive secondary objectives will be studied:~        1. Describe the tolerability and potential toxicity of sitagliptin.~        2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100.~        3. Describe the cumulative incidence of grades III-IV acute GvHD.~        4. Describe the engraftment kinetics of absolute neutrophil count and platelets.~        5. Describe the incidence of infections occurring during the 100 days post-transplant.~        6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.~        7. Describe overall survival.~        8. Describe the incidence of chronic GvHD.~        9. Describe the cumulative incidence of relapse of the primary hematological malignancy.~   "
28544|NCT02683512|"~     Database for information on individuals affected with glycogen brancher deficiency, also~     known as glycogen storage disease type IV~   "
28545|NCT02683499|"~     The aim of the study is to assess the marginal fit following preparation finishing with~     ultrasonic tips of porcelain veneers compared to the ordinary preparation using burs only.~     Two-hundred and forty crowns prepared to receive porcelain veneers (in a split-mouth~     design). On one side of the mouth, the prepared surfaces will be finished with ultrasonic~     tips. Marginal fit is measured by a 'cement replica technique'.~   "
28546|NCT02683486|"~     The aim of this study is to assess whether an auto-titrating oxygen system can maintain~     constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT)~     during activities of daily living.~      Currently LTOT is provided at a constant fixed-flow rate e.g. 2 litres per minute all the~     time after appropriate assessment. The flow rate is not changed during usual household~     activities but is increased for walking. A number of studies have investigated the SpO2 of~     patients on LTOT during the daytime in patients' homes. The results have shown that~     patients' SpO2 decreases intermittently whilst they are doing activities of daily living~     such as watching television, putting away the shopping, having a shower or bath and dressing~     and undressing. This is a problem as it can lead to breathlessness, increased stress on the~     heart and affect brain function. In order to correct the drop in SpO2 that patients~     experience during everyday activities, the investigators have developed an oxygen system,~     which can automatically change the amount of oxygen delivered depending on a patients'~     oxygen saturations - an auto-titrating oxygen system. In this study, patients on LTOT will~     be asked to simulate a series of activities of daily living twice: once whilst on their~     usual fixed-flow oxygen therapy and once on the auto-titrating oxygen system. The activities~     will be carried out in a hospital setting. During the activities, SpO2 will be recorded~     continuously. The main outcome of interest from the study will be the SpO2 throughout the~     study on fixed-flow oxygen and the auto-titrating oxygen system.~   "
28547|NCT02683473|"~     The purpose of this study is to measure energy expenditure during the first 3 months of life~     in infants.~   "
28548|NCT02683460|"~     This study aims to compare the clinical results of patella resurfacing or not under~     subvastus approach in total knee arthroplasty. Even though the excellent results of total~     knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the~     patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some~     surgeons always performed patella resurfacing during total knee arthroplasty but the others~     didn't do that. It's up to surgeon's preference. There were several studies of patellar~     resurfacing or not in TKA. But previous studies almost have been done under other approach,~     not a subvastus approach.~      This study prospectively randomized patients receiving bilateral TKA with patellar~     resurfacing or not in each knee. Patients preference and clinical results was investigated~     in both knee of same patients who received patellar resurfacing or not during minimum 2 year~     follow up.~   "
28549|NCT02683447|"~     The proportion of older acute care physicians (ACPs) has been increasing. Ageing is~     associated with physiological changes and research investigating how such age-related~     physiological changes affect clinical performance is lacking. Specifically, Crisis Resource~     Management (CRM) consists of essential clinical skills in acute care specialties which when~     absent, can significantly impact patient safety. As such, the goals of this study are to~     investigate whether ageing has a correlation with baseline CRM skills of ACPs and whether~     ageing influences learning from high fidelity simulation.~   "
28550|NCT02683434|"~     The purpose of our study is to investigate the effects of Kinesio Taping application, which~     is applied before the training period, on postural stability in young soccer players.~   "
28551|NCT02683421|"~     Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects~     with active RA and concordance with clinical symptomology.~   "
28552|NCT02683408|"~     Diosmiplex is a product marketed for the management of diseases due to venous and~     microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of~     small arteries and impaired microvascular flow. This study will examine the effects of~     diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.~   "
28553|NCT02683395|"~     The purpose of this research study is to evaluate safety, pharmacokinetics,~     pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects~     with advanced solid tumors (including lymphoma), acute myeloid leukemia (AML), or high-risk~     myelodysplastic syndrome (MDS).~   "
28554|NCT02683382|"~     Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and~     grittiness of eyes. The objective of this study is to investigate the effects of a~     moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around~     the eyes.~   "
28555|NCT02683369|"~     Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose~     iron dietary supplement. The investigators seek to determine if the low-dose iron dietary~     supplement will restore iron levels to normal range with fewer side effects than typically~     experienced at higher doses of iron supplementation.~   "
28556|NCT02683356|"~     Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to~     preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain,~     restore physiological vasomotion, and avoid late adverse events including restenosis and~     scaffold thrombosis. Although randomized clinical trials in low risk patients to date~     suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several~     reports have raised concerns regarding the scaffold thrombosis highlighting the importance~     of technical considerations regarding lesion preparation and scaffold expansion. OCT offers~     the opportunity to plan the procedure and optimize the implantation of BVS.~      The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is~     superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a~     pre-procedural OCT and applying corrective measures in case of suboptimal treatment result~     as indicated by OCT).~   "
28557|NCT02683343|"~     Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective~     screening test. Many anatomical aspects of the syndrome have been studied including the~     dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators~     have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing~     surgery for the condition. Assuming that this muscle may have a dynamic role in the~     development of the condition, the investigators attempted to quantify this muscle using~     ultrasound (US).~      The purpose of this study was to devise a technique to evaluate the amount of muscle~     overlying the carpal tunnel.~      The hypothesis is that patients with carpal tunnel syndrome will have significantly more~     muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.~   "
28722|NCT02681198|"~     The purpose of this study is to determine the pharmacokinetics, safety and tolerability of~     lofexidine HCl in the presence of paroxetine in healthy adults.~   "
28563|NCT02683265|"~     This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is~     designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD.~     Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of~     ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled.~      There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include~     washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an~     eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a~     6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR®~     responders, and a two-week follow-up call after study completion or early discontinuation to~     assess for ongoing adverse events and concomitant medications.~      Up to 150 subjects will be enrolled in this trial to allow for subjects who improve~     significantly during the behavior training phase and drop-outs. Once 74 subjects have~     completed the double-blind phase, no additional subjects will be enrolled in the trial.~     Subjects who are already enrolled at that time will be allowed to complete the trial.~      The primary objective of this study is to establish that an optimal dose of Aptensio XR®~     will result in a significant reduction in ADHD symptoms compared with placebo in children~     ages 4 to under 6 years~   "
28564|NCT02683252|"~     Study on quantitative perfusion parameters acquired on MR imaging of patients with~     non-tumoral pathology of the musculoskeletal system.~   "
28565|NCT02683239|"~     Approximately 10,000 patients will participate in this study to further characterize the~     safety profile of fasinumab and provide data on long-term exposure to provide efficacy data.~      In addition to their participation in the main study, approximately 800 patients will~     participate in a sub-study to characterize the onset of pain relief by fasinumab.~   "
28566|NCT02683226|"~     The purpose of this study was to determine whether dual treatment with metformin and~     alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in~     the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin~     resistance and beta cell function.~   "
28567|NCT02683213|"~     The purpose of this study is to investigate whether routine administration of fluoxetine~     20mg once daily in the 6 months initiated during the acute stroke improves the patient's~     functional outcome.~      EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind~     placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.~      The anticipated numbers of participants is 1500 at 30 centers in Sweden. As of 31 January~     2016, EFFECTS has recruited 244 participants at 24 active centers.~   "
28568|NCT02683200|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body~     radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is~     a specialized radiation therapy that delivers a single, high dose of radiation directly to~     the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining~     MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.~   "
28569|NCT02683187|"~     This study is being done to determine the role of a hormone, glucagon-like peptide 1~     (GLP-1), on insulin secretion and to study how GLP-1 works in in diabetic individuals as~     compared to non-diabetic individuals, under fasting conditions.~      GLP-1 is a naturally occurring hormone made in the intestines. It is released into the~     circulating blood after eating and helps to control the blood glucose levels by increasing~     insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes~     insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This~     research is being done to address these questions and better understand the function of~     GLP-1.~      In this research, the investigators will use a synthetic form of Exendin-9 to determine the~     effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts~     as a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1~     hormone. Exendin-9 is an investigational compound, which means it is still being tested in~     research studies and is not approved by the U.S. Food and Drug Administration (FDA).~      In this study, the investigators will also use the drug Sitagliptin, which is an~     FDA-approved drug for the treatment of type 2 diabetes mellitus. In this study, use of~     Sitagliptin is considered investigational since it is not being used for treatment of~     diabetes but is instead being used to understand how GLP-1 works and to better understand~     how medications like Sitagliptin work in patients with type 2 diabetes mellitus.~   "
28570|NCT02683174|"~     Syncope is a common Emergency Department (ED) presentation but the underlying diagnosis is~     not apparent in 60% of patients after assessment and serious adverse event rate is 7% at one~     month with most having acute cardiovascular events, also more likely to be unexplained after~     ED assessment. Many cardiovascular events are due to arrhythmia, difficult for clinicians to~     diagnose, as examination and Electrocardiogram (ECG) findings may both be normal and~     symptoms have resolved by the time the patient gets to the ED. Currently establishing a~     cardiac arrhythmia as the cause of syncope rests on correlating the arrhythmia with symptoms~     using monitoring devices such as Holter but these all have significant drawbacks. The~     clinical challenge in the ED is therefore to identify the moderate and high-risk patients~     and refer them for further investigation and monitoring if appropriate. The logistics of~     arranging follow up within a timely period of the patient's ED visit is often problematic~     for a variety of reasons including availability of timely specialty outpatient appointments,~     a lack of consensus of the specialty to whom the syncope patient should be referred~     (cardiology, medicine, neurology, general practice) and availability of Holter and other~     monitoring devices. For this reason most high and medium risk patients are admitted to~     hospital.~      Previous syncope clinical decision rules have not been well adopted due to their lack of~     sensitivity and specificity probably due to the varied and heterogeneous nature of~     potentially serious causes. However, the majority of patients with syncope have no serious~     underlying pathology and do not require hospitalisation. Rather than continued attempts at~     risk stratification of outcome based on presentation, more research is required into how we~     can better improve diagnosis and therefore treatment in order to provide improved patient~     benefit. We believe that ambulatory patch monitoring will allow better and earlier~     arrhythmia detection and plan to assess the ability of a 14-day ambulatory patch to detect~     serious arrhythmic outcomes at 90 days.~   "
28571|NCT02683161|"~     The study will evaluate the feasibility of integrating an intensive pre- post-surgical~     smoking cessation intervention into a hospital setting, and assess measures of postsurgical~     recovery as a function of smoking cessation status.~   "
28572|NCT02683148|"~     DHEA is a natural allosteric inhibitor of glucose-6-phosphate dehydrogenase (G6PD). G6PD is~     a key regulatory enzyme for the survival of synovial sarcoma. The investigators postulate~     that they can inhibit the production of NADPH in synovial sarcoma and cause cell death by~     using a naturally occurring G6PD inhibitor.~   "
29271|NCT02674009|"~     The primary purpose for this study is to evaluate the duration of response defined as~     duration from first documented response of complete response (CR) or partial response (PR)~     until disease progression (as determined by the treating physician) for laBCC patients.~   "
28573|NCT02683135|"~     Large spikes in blood glucose experienced after meals in people with type 2 diabetes are~     known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve~     blood glucose control in people with type 2 diabetes but it is unclear how these two~     strategies interact to affect blood vessel function and inflammation. We will examine how~     following a short-term low carbohydrate high fat diet (4 days) with or without post-meal~     walking impacts markers of blood vessel function and inflammation. We will also examine how~     a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood~     glucose control and blood vessel function. Findings will help determine the best lifestyle~     approach for improving cardiovascular health in type 2 diabetes.~   "
28574|NCT02683122|"~     The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial~     pneumonia in intensive care is not yet defined.~   "
28575|NCT02683109|"~     This is a 4-week, multicenter, randomized, double-blind, parallel group and active~     controlled study.~      Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of~     either FDC of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of~     tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose~     is to show non-inferiority between the FDC and the free combination of tiotropium and~     olodaterol in patients with COPD.~   "
28576|NCT02683096|"~     Our central hypothesis is that screening newborn infants who either fail their newborn~     hearing test or have a diagnosis of small for gestational age (SGA) will lead to better~     identification of infants with congenital CMV infection and enhanced rates of therapeutic~     intervention. This has the potential to significantly improve outcomes for infants with this~     common viral infection. This particular cohort of patients have not been well studied~     locally or regionally. In addition, in view of current legislation that will be effective in~     January, 2016 this is a timely project that will provide preliminary data for future~     statewide recommendations around CMV testing of newborn infants. This will be a~     pilot/feasibility study to obtain preliminary data for an Illinois Department of Public~     Health (IDPH) Title V grant. Although not guaranteed, preliminary discussions with the IDPH~     are highly encouraging giving the statewide interest in this topic.~   "
28577|NCT02683083|"~     Primary purpose of the clinical study is to evaluate the safety, biodistribution and~     radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with~     HER2+ breast cancer.~      Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB~     Anti-HER2 VHH1 in patients with HER2+ breast cancer.~   "
28578|NCT02683070|"~     Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general~     anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this~     study, the investigators will enroll male patients undergoing elective prostate surgery with~     urinary catheterization after anesthetic induction, and compare the efficacy of pudendal~     nerve block (PNB) and intravenous tramadol in prevention of CRBD.~   "
28579|NCT02683057|"~     Our study addresses a previously selected population or by physical activity but not for~     semen quality semen donor candidates donation program within the clinic.~      Total physical activity was analyzed according to the universally accepted international~     physical activity questionnaire (IPAQ) The existence of confounding factors associated She~     purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters~     determinations will be made to exercise.~   "
28580|NCT02683044|"~     Randomized, experimental, non-inferiority clinical trial to determine the comparative~     effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED)~     with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's~     Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15~     mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the~     body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists~     of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4~     Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600~     pulses at its base. Total duration: 3 weeks.~      Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function,~     5-item version (IIEF-5). Penile blood flow.~      Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.~   "
28581|NCT02683031|"~     We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+~     ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear~     stage i.e: cleavage failure to find out if there is any improvement in embryonic~     developmental stages.~   "
28582|NCT02683018|"~     The use of cannabis for severe medical conditions is being legalized in different states,~     increasing the mandate to make cannabis legal for medically ill patients. However, there is~     a lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol~     (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related~     anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of~     THC, is approved for nausea/vomiting in chemotherapy patients. These medications have been~     found to be effective for these disorders, but there remains an interest in studying~     cannabis, partly due to the numerous cannabinoids contained within the cannabis plant. Among~     these is cannabidiol, which does not produce subjective effects, but has been shown to have~     potent anti-inflammatory effects. In addition, there is data indicating that cannabidiol may~     be effective for neuropathic pain and nausea/vomiting.~      The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as~     pain, nausea/vomiting, and quality of life in seriously ill participants. While there is~     data beginning to emerge that cannabis may have a beneficial effect on these symptoms, there~     are few placebo controlled, double-blind studies. Additionally, the administration of~     cannabis to medically ill patients may be limited by its subjective effects, such as~     anxiety, intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC~     (about 15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized~     that some of these effects can be avoid, while maximizing the therapeutic effects, if any.~   "
28594|NCT02682862|"~     Single centre, open-label, random order, cross-over trial, recruited over a period of~     approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn~     subjects may be replaced.~      This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in~     smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function~     test called impulse oscillometry.~   "
28583|NCT02683005|"~     Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the~     treatment of hepatitis C (HCV) that are highly effective, orally administered, well~     tolerated and preclinical evaluations in animal models indicate safe administration during~     pregnancy. This project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF~     treatment for 12 weeks during the second and third trimester. If proven to be effective,~     antenatal treatment of HCV with LDV/SOF will prevent maternal HCV-related liver disease,~     perinatal transmission of HCV, and community transmission of HCV.~   "
28584|NCT02682992|"~     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser~     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients~     receiving combined modality therapy consisting of chemotherapy and radiation therapy for~     head and neck cancer.~   "
28585|NCT02682979|"~     Demographically, the geriatric population is expanding. It is also increasingly found in the~     emergency services.However, emergency services are not designed to accommodate these~     patients, whose needs are specific. This population is defined by complex physical and~     psychosocial needs, included in a comprehensive geriatric assessment too complex to be~     carried out in the emergency services.~      Many publications focused on ways to prevent potentially avoidable visits to geriatric~     patients in emergency services. People rely upon a therapeutic limitation code established~     for these patients to determine the intensity of the care that may be given to them.~     However, few geriatric patients arriving in the emergency services were already given such a~     code.~      As a consequence, the intensity of the care given to these emergency patients is influenced~     by the perception of the functional and cognitive status of the patient, even if part of~     this perception is incorrect. Moreover, it is also well established that the outcome of~     geriatric patients with severe pathologies at admission is often poor and that there is a~     need to find alternatives to the intensive treatment offered.~      The goal of this study will be to determine the prevalence of the presence of a therapeutic~     limitation code in geriatric patients at hospital admission / admission to the emergency~     department, and when they leave the hospital. This will be carried out for all geriatric~     patients residing or placed in nursing homes at the end of the hospitalization.The~     investigators postulate that establishing a therapeutic limitation code for these fragile~     patients, before they leave the hospital for a nursing home, would reduce the number of~     future admissions of these patients in the emergency department.~   "
28586|NCT02682966|"~     This is a prospective study in patients who undergo routine postoperative troponin~     assessment after major elective noncardiac surgery. Two groups are created based on~     postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I~     levels ≥ 60 ng/L and a control group with troponin levels < 60ng/L. Our objective is to~     determine the association of PMI with CAD and PMI with pulmonary embolism using coronary~     computed tomography angiography in patients undergoing major elective noncardiac surgery.~   "
28587|NCT02682953|"~     This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for~     mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed~     for patients to undergo bone marrow transplantation and some patients fail to respond to~     current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other~     patient populations and we plan to investigate whether this intervention can act in concert~     with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone~     marrow transplantation. Twenty patients will be identified by participating hematologists~     who have failed to respond adequately to chemotherapy. When it is deemed appropriate to~     attempt an additional stem cell mobilization protocol, these patients will be administered~     chemotherapy as determined by their primary treating hematologist and additionally receive~     daily HBO2 (2.5 atmospheres absolute [ATA] for 90 minutes) for 3-8 days. At intervals, blood~     samples will be obtained as is the normal transplantation protocol practice to assess~     whether adequate stem cells are present in blood for the patient to proceed with~     transplantation. The project is anticipated to take one year to complete.~   "
28588|NCT02682940|"~     A single center pilot study assessing the Vigilant Diabetes Management System for the~     prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.~   "
28589|NCT02682927|"~     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the~     efficacy, safety, and PK of ZX008 when used as adjunctive therapy for uncontrolled seizures~     in pediatric and young adult subjects with Dravet syndrome. After an initial Screening and~     Baseline charting of seizure frequency, subjects who qualify for the study will be~     randomized (1:1:1) to receive either ZX008 (0.2 mg/kg/day, 0.8 mg/kg/day; maximum dose: 30~     mg/day) or placebo. Randomization will be stratified by age group (< 6 years, ≥6 to 18~     years). All subjects will be titrated to their randomized dose over a 14-day Titration~     Period. Following titration, subjects will continue treatment at their randomly assigned~     dose over a 12-week Maintenance Period. Subjects exiting the study will undergo a 2-week~     taper, unless they enroll in a follow-on study. Subjects will be followed for post-study~     safety monitoring. Parents/caregivers will use a diary daily to record the number/type of~     seizures, dosing, and use of rescue medication.~   "
28590|NCT02682914|"~     The main objective of this study is to determine the risk factors and etiologies of ischemic~     stroke in Korean young adults. Both well-documented risk factors and little known life-style~     related risk factors such as life-style habits, psychological distress including~     occupational distress, perceived stress and depression will be evaluated by comparison with~     healthy controls using a structured questionnaire. Secondary objectives are to determine~     stroke outcomes such as mortality, recurrent vascular events and post-stroke epilepsy in~     these patients.~   "
28591|NCT02682901|"~     The main objective is to demonstrate the effects of early dopaminergic activation on the~     autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes.~     The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function~     measured by assessing sympathetic and parasympathetic function using conventional measures~     of autonomic function, including power spectral analysis of heart rate as well as peripheral~     autonomic function using sudorimetry and laser scanning of peripheral microvascular~     autonomic control.~   "
28592|NCT02682888|"~     to examine the association between trait and defensive network connectivity and the~     modulatory effect of oxytocin on it~   "
28593|NCT02682875|"~     The study evaluates with Artificial Neural Network (ANN) of pain scales in children. Pain of~     these patients' will be evaluated by many pain scales in the postoperative period.~   "
28596|NCT02682836|"~     Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life~     is a major goal of care. There is a strong body of evidence that exercise can reduce or~     manage fatigue, depression and insomnia in breast cancer patients; however, the evidence~     base is overwhelmingly in early stage cancer patients. The purpose of this study is to see~     if a home-based, self-directed walking program can have similar benefits in women with an~     MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity~     will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the~     primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention~     of study participants and measuring changes between baseline, 3 months and 6 months in~     additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a~     levels and sarcopenia between baseline and 3 months. The design is a single arm intervention~     trial in 30 patients. Findings from this study will provide preliminary data for a grant~     application to test the physical activity intervention in a randomized controlled trial~     (RCT) in a large sample of women with metastatic breast cancer.~   "
28597|NCT02682823|"~     This study is designed to evaluate RLHFs concerning administration of the tocilizumab~     autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving~     subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle~     safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will~     be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and~     health care professionals (HCPs) will administer the AI-1000 G2 injection to the remaining~     study participants. The study will enroll approximately 45 participants with RA across three~     cohorts. Group 2 will also include 15 paired CGs to administer the injection, and Group 3~     will include 15 paired HCPs to administer the injection. With an expected drop-out rate of~     20%, the target enrollment (to achieve a final sample/ratio of 45:15:15) will be 95~     individuals overall.~   "
28598|NCT02682810|"~     This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the~     Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.~   "
28599|NCT02682797|"~     Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a~     splitting of the neurosensory retina occurs usually in the inferior temporal. Patients~     usually have good visual acuity and are asymptomatic. Combination of an inner and outer~     layer hole is considered high risk factor for development of a schisis detachment. The most~     important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary~     treatment is provided. In clinical examination, both can appear very thin and transparent.~      Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and~     regular follow-up controls have to be conducted for sufficient recognition of progression.~   "
28600|NCT02682784|"~     Over one million individuals in the United States meet criteria for cocaine use disorders.~     Relapse rates are highest among cocaine-dependent (CD) populations. Social stress is a~     significant risk factor for relapse. Data from human neuroimaging studies suggest that~     top-down prefrontal cortical inhibition of amygdala activity controls emotional responses~     to social stimuli. A growing literature suggests that hypoactivity in the medial prefrontal~     cortex coupled with increases in amygdala activity underscore the vulnerability of CD~     individuals to relapse. Neuroimaging studies of corticolimbic network activity (functional~     connectivity) have been conducted in CD subjects at rest. Compared with healthy controls, CD~     subjects exhibited lower corticolimbic connectivity and the degree of corticolimbic~     uncoupling was associated with time to relapse. Studies measuring corticolimbic connectivity~     during exposure to a social stress task in CD subjects could provide critical insight into~     the neurobiologic mechanisms that underscore the sensitivity of CD individuals to social~     stress. Moreover interventions that improve corticolimbic connectivity in CD subjects may be~     effective therapeutic strategies for preventing relapse in CD populations. Oxytocin (OT) is~     an anxiolytic neuropeptide that attenuates amygdala responses to aversive social cues. In~     order to better understand the neurobiologic mechanisms that control emotion-related~     behavior in CD populations, we propose a double-blind placebo (PBO) controlled study using~     blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) to measure~     (1) corticolimbic functional connectivity during the Montreal Imaging Stress Task (MIST) and~     (2) amygdala activity in response to an implicit facial affect recognition paradigm in~     groups of CD individuals (CD n=80) and healthy non-dependent controls (HC, n=80). Prior to~     the scanning session, participants will receive either intranasal OT (24 IU) or PBO spray~     (n=40 per treatment group). The order of the tasks will be counterbalanced.~   "
28601|NCT02682771|"~     Obesity, due to excess fat in the thoracoabdominal region, can promote changes in~     respiratory function and lung function, leading to reduction in lung volume and capacity.~     Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent~     to this procedure. The objective of this study was to evaluate and compare the effects of~     the application of bilevel positive airway pressure and exercises with inspiratory pressure~     with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle~     strength, respiratory muscle strength and prevalence of pulmonary complications after~     bariatric surgery.~   "
28602|NCT02682758|"~     The influence of xenon anaesthesia on transpulmonary pressure and tidal volume distribution~     will be investigated in a prospective cohort study in 10 patients of normal weight and 10~     obese patients undergoing routine xenon-based, general anaesthesia for surgery.~   "
28603|NCT02682745|"~     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine~     after single oral administration of TALION tab, a IR formulation of bepotastine as reference~     drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
28604|NCT02682732|"~     The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow~     (BM) sampling serves as a window that represents all AML cells distributed throughout the~     BM, an assumption that has yet to be questioned. Simulation in mice led to inconsistent~     representation of the full BM, which can incorrectly suggest the absence of leukemic cells.~     Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the~     body using for instance a radioactive sugar. In one report, its use in human AML has~     provided proof-of-principle evidence of unequal distribution of AML cells in BM.~     Accordingly, the alternative hypothesis is to test if PET scan can demonstrate if BM~     geography can alter AML cells spread and home them as distinct areas rather than uniform~     spread as if they are distributed in liquid state.~   "
28605|NCT02682719|"~     The purpose of this study is to determine whether LCZ696 (valsartan/sacubitril) is safe and~     has beneficial effects on the heart and blood vessels in patients with high blood pressure~     and/or diabetes or other risk factors for developing heart failure (elevated levels of~     natriuretic peptide and elevated left atrial volume index). Patients will be randomized to~     receive LCZ696 or valsartan (and matching placebo) for 18 months to assess the impact on~     left ventricular diastolic function.~   "
28606|NCT02682706|"~     Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly~     into heat. Active BAT increases energy expenditure and can thereby counteract obesity and~     insulin resistance. Currently, the imaging method of choice to assess BAT morphology and~     function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to~     ionizing radiation, thus impeding larger prospective studies.~      Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary~     small-scale studies are promising.~      The overall aim of this research proposal is to develop reliable magnetic resonance imaging~     techniques to facilitate the study of brown adipose tissue in human adults, specifically in~     the context of endocrine disease.~      Specifically, investigators want to~        1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold~          induced nonshivering thermogenesis as a measure of BAT activity.~        2. Assess the intra-individual variance of BAT volume measured by MRI.~        3. Evaluate direct measurement of BAT temperature by functional MRI.~   "
28607|NCT02682693|"~     Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and~     inhibits metastatic progression in multiple mouse models.~      In a retrospective analysis it could be demonstrated that elevated expression of RANK was~     found in 14.5% of patients overall, with a significant predominance in patients with~     hormone-receptor-negative disease. Expression of RANK was associated with a higher~     pathological complete response rate but with a shorter disease-free and overall survival.~     The ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone~     health, and can be administered without added toxicity.~      It appears therefore reasonable to test denosumab, a clinically available antibody against~     RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to~     neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in~     relation to the expression of RANK.~   "
28608|NCT02682680|"~     A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability~     of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline~     statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for~     glycated hemoglobin (HbA1c) (> 7.0%) and low-density lipoprotein (LDL) cholesterol (> 2.0~     mmol/L).~   "
28609|NCT02682667|"~     Background:~      Cancer has a major impact in the United States and across the world. In 2015, over 1.5~     million new cases of cancer were diagnosed in the U.S. Researchers want to study samples~     from people with cancer or a pre-malignant condition. They hope to develop more effective~     treatments.~      Objective:~      To better understand the biology of malignancies and why certain cancers respond differently~     to treatment.~      Eligibility:~      Adults at least 18 years old with cancer or a pre-cancerous condition.~      Design:~      Participants will be screened with a medical history, physical exam, and blood tests. Their~     diagnosis will be confirmed by the NCI Laboratory of Pathology.~      Participants will send tissue blocks or slides from their original tumor biopsy.~      At least once, participants will have a medical history, physical exam, and blood and urine~     tests.~      Participants may have the following tests. They may have them more than once:~      Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample~     cells are taken out. The rest of the blood is returned by a needle in the other arm.~      Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the~     hipbone. Bone marrow will be taken out through the needle.~      Piece of cancer tissue taken by a needle and syringe.~      Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission~     tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a~     machine that takes pictures.~      A small piece of skin removed.~      Participants will be contacted by phone once a year to find out how they are doing.~   "
28610|NCT02682654|"~     This study will look to examine the overall performance of a custom fit knee or ankle brace~     as a means of providing ankle or knee joint support in subjects that have determined the~     need for bracing based upon chronic joint instability and/or joint swelling and pain~     following daily activity.~   "
28611|NCT02682641|"~     Patients with mantle cell lymphoma (MCL) have a median survival of 3-5 years despite~     treatment. Indeed, the best therapeutic approach for different patients with MCL remains to~     be established, coexisting different options of immunochemotherapy regimes which may include~     autologous transplantation in first-line treatment or rituximab maintenance.~      Moreover, last years MCL starts to be recognized as a heterogeneous disease both from~     biological and clinical stand points. For instance, MCL cases with a non-nodal clinical~     presentation, usually have distinctive biological features such as SOX-11 negativity,~     hypermutated IGHV genes and a low number of genetic lesions associated to . The outcome of~     these cases is much more favourable compared to conventional MCL, reaching median survivals~     over 7 to 10 years even receiving less intensive treatments. In addition to that, up to 30%~     of the patients with newly diagnosed MCL can be safely deferred from initial therapy until~     progression . Therapeutic abstention may be prolonged for more than one year in 50% of~     cases. These patients usually show longer survivals from the start of treatment compared to~     patients immediately treated after diagnosis. Therefore, all these observations indicate~     that there are indolent clinical forms in MCL, so its clinico-biological identification is~     crucial to tailor treatment appropriately. However, at present there is no consensus on the~     diagnostic criteria or treatment recommendations in cases of indolent MCL. This results in~     difficulties for the identification of these forms in the clinical practice as well as with~     a certain therapeutic in definition, as indolent forms of MCL can be treated either with~     therapeutic abstention until progression or receive immediate treatment with conventional or~     more intensive immuno-chemotherapy regimes, which may even include an autologous~     hematopoietic stem cell transplantation. With the emergence of new biological agents in the~     therapeutic arsenal of MCL arises the question whether a completely different approach with~     new drugs and chemotherapy-free could be more appropriate in selected subsets of patients~     such as indolent MCL forms.~   "
28612|NCT02682628|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
28613|NCT02682615|"~     Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the clinical~     goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of~     different potential interference factors to the accuracy of measurement (changing~     concentration of norepinephrine, generally severity of the basic disease - APACHE II score).~   "
28614|NCT02682602|"~     The objective of this study is to analyze subjects having a normal hip and compare the in~     vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a~     diseased hip and then later post-operative to their implanted hip. Ten subjects will have a~     normal hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will~     be re-analyzed at six months post-operative after implantation of a THA.~   "
28615|NCT02682589|"~     Randomized, multicenter, phase III trial to compare the short and long outcomes of~     laparoscopic CME with open CME in treating patients with locally advanced colon cancer.~   "
28616|NCT02682576|"~     The objective of the study is to define the analytical repeatability of quantifying~     flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using~     upper arm cuff occlusion.~   "
28618|NCT02682550|"~     The NTF_PT_2014 multicenter study aims to collect, store, and analyse plasma and serum from~     polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address~     1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation~     factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic~     response and regenerative potential on an organ-, cell, and molecular level, and 3) how~     could a specific organ- and immune-monitoring predict the clinical outcome.~   "
28619|NCT02682537|"~     Assessment of resting energy expenditure (REE) by indirect calorimetry (IC) in 1400 healthy~     individuals for arithmetical transformation into an bedside tool to estimate energy~     requirements in dietary practice (BASAROTs). A multinational, multicenter, prospective~     cross-sectional study.~   "
28620|NCT02682524|"~     A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical~     trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of~     patients with osteoarthritis of the knee~   "
28621|NCT02682511|"~     The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study~     is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous~     systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).~   "
28622|NCT02682498|"~     This study seeks to determine whether a new sustained-release local anesthetic solution~     (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after~     surgery will decrease opioid consumption and adverse events in opioid-tolerant patients~     presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study)~     group will use less opioid in the first 48 hours post-operatively than the control group.~   "
28623|NCT02682485|"~     Rationale: The surgical complication of intestinal anastomotic leak remains a clear and~     present danger to patients despite advances in surgical technique and ever more powerful~     antibiotics. No surgeon is immune from this complication and leak rates have not changed in~     decades. The consequences of a leak (peritonitis, sepsis, death) can be so severe that in~     the case of rectal cancer, diverting ileostomies are routinely performed to divert the fecal~     stream away from the healing anastomosis. We have recently discovered that certain~     intestinal bacteria, with the capacity to express collagenase and cleave MMP9 (Matrix~     metallopeptidase 9) to its active collagen degrading form, play a key and causative role in~     anastomotic leak. These bacteria often escape elimination due to the failure of current~     antibiotic regimens and their delivery methods to remain functionally durable at anastomotic~     tissue sites.~      Purpose: This phase II clinical trial will track, in real time, the process of anastomotic~     healing and its associated microbiome by performing serial endoscopic surveillance (SES)~     following rectal cancer resection. By capturing anastomotic images and the associated~     microbial and inflammatory mediators from anastomotic fluids via SES performed at three time~     points following rectal cancer resection, we will correlate healing to microbial composition~     and inflammatory mediator status. Patients will be randomized and, at each time point, will~     receive lavage of their anastomosis with either saline or a triple antibiotic solution~     (ciprofloxacin, metronidazole, neomycin). An anastomotic healing score captured during SES~     will be compared between the two treatment arms and correlated to microbial and inflammatory~     mediator analyses of fluid samples to determine how intestinal microbes influence the~     process of anastomotic healing.~   "
28624|NCT02682472|"~     Admission into a care home for people with dementia has been linked with both positive and~     negative psychological outcomes for both the resident and their carers. Whilst some people~     with dementia adjust quickly, many never adjust at all or adjustment is complex and linked~     to cognitive and behavioural decline (Wilson et al, 2007). Therefore, support for healthy~     adjustment is needed.~      Recent research (Aminzadeh et al., 2013; Sury, Burns and Brodaty, 2013, Sussman and Dupuis,~     2013) has identified factors that influence different relocation outcomes and prevent~     adverse reactions. There are currently no interventions that support successful adjustment~     by emphasising the positive factors found to influence relocation outcomes while mitigating~     the effects of negative influences and addressing any missed pre-admission procedures,~     reported in the literature.~      The current project seeks to design an intervention that predominantly builds on the work of~     Sury et al (2013) and focuses on promoting healthy adjustment through an enhanced best~     practice based admission process.~      The intervention will be developed through systematic review of the literature and~     consultation with professional experts, service users, care home staff and carers. The~     current study will serve as a feasibility (pilot) study and test the acceptability of the~     intervention design, examine recruitment and dropout and establish sample size for future,~     larger studies. It also aims to examine whether the intervention indicates an improvement in~     residents' quality of life, mood, overall adjustment and carer satisfaction with care.~      All participants will receive a subset of the same intervention, specifically tailored to~     their needs and with elements delivered by staff, carer or psychologist. Staff and~     researchers will assess the improvement indicators mentioned above using relevant~     psychometric measures at baseline, post intervention completion and at one-month follow up.~     Indirect measures (interviews and staff field notes) will also be used to indicate~     intervention fidelity and feasibility.~   "
28625|NCT02682459|"~     The natural course of extracapillary glomerulonephritis is severe leading to End-Stage Renal~     Disease (ESRD) or death in most cases. Despite immunosuppressive treatment, long-term renal~     outcome remains poor since active crescents usually progress to fibrotic scars with~     glomerular occlusion and disruption.In experimental models Angiotensin Converting Enzyme~     (ACE)-inhibitor therapy targeting the over-expression of angiotensin type 1 (AT1) receptors,~     that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the~     formation of crescents and their fibrotic evolution. Should these drugs have similar effects~     in humans, ACE-inhibitor therapy on top of standard immunosuppression might be instrumental~     to prevent ESRD and promote renal function recovery in clinical practice.~   "
28626|NCT02682446|"~     After endoscopic resection of early gastric cancer (EGC), there remained concerned about the~     development of the metachronous gastric neoplasm (MGN). The aim of this study was to~     evaluate the role of H. pylori eradication for reducing MGN after ESD and the efficacy of~     serum pepsinogen (PG) for predicting development of MGN after endoscopic submucosal~     dissection (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The~     investigators enrolled the participants who were tested serum PG I and II at the time of ESD~     for EGC, from January 2007 to May 2013 in single tertiary center, retrospectively. The~     baseline characteristics of the participants, H. pylori status, and serum pepsinogen were~     analyzed for the development of the MGN.~   "
28692|NCT02681588|"~     This was a prospective bi-centric study, exposed-unexposed. In an effort to better~     understand the potential independent effect of maternal obesity on fetal growth,~     investigators designed a prospective study, comparing fetal growth between normal weight~     (18.5 ≤ BMI < 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes~     and hyperglycaemia was screened and treated throughout pregnancy.~   "
28627|NCT02682433|"~     Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional~     problems of the female reproductive system. Many articles examine the efficacy of diagnostic~     hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most~     of the articles are from the last decade, but the subject has been laid aside in the recent~     years. Antonio Simone Lagana and his group have found that there is 100% correlation in~     uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78%~     correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his~     group have found that there is a significant advantage to three-dimensional~     sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. No~     significant difference was observed, and 97% correlation was found, comparing~     three-dimensional sonar and hysteroscopy. Work rationale is that there is a reason to~     reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving~     technologies, and an improvement in resolution and three dimensional technologies.~   "
28628|NCT02682420|"~     Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create~     an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for~     hemodialysis.~   "
28629|NCT02682407|"~     The purpose of this study is to evaluate the safety and tolerability of OMS721 in subjects~     with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3~     Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate~     Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and~     neutralizing antibodies (Nab).~   "
28630|NCT02682394|"~     Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of~     Pancreatic Steatosis in Patients with Pancreatic Cancer~   "
28631|NCT02682381|"~     Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose~     of this study is to evaluate the safety and efficacy of teduglutide in children up to the~     age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to~     receive the study drug or to participate in a standard-of-care arm. All participants who~     complete the study may be eligible to receive the study drug in a long-term extension study.~   "
28632|NCT02682368|"~     Both acute gallbladder pathology and diverticular disease are common conditions met in~     emergency departments in the western world and comprise the bulk of admissions throughout~     general surgical calls. On the other hand both entities need imagistic confirmation and~     description to tailor further management, which may be not readily available at the moment~     of patient's presentation in A&E's doorstep or after referral to the on call general~     surgeon. These delays may lose the window of opportunity for emergency surgery or prolong~     unnecessary admission for a patient with known condition which may need just a fast~     exclusion of a more advanced stage and then be further treated conservatively or even~     discharged.~      The increased length of stay, as investigators know and expect is rising the costs of~     healthcare and this is a very delicate subject in nowadays medical practice. Investigators~     think that USS performed at the bedside will help in decreasing the length of stay,~     especially for weekend admissions when radiology is not readily available.~      Ultrasound scanning (USS) has become very popular over the last half century and the~     equipment has become more compact, of a higher quality and less expensive, which has~     facilitated the growth of point-of-care ultrasonography — that is, USS performed and~     interpreted by the clinician at the bedside. The concept of an 'ultrasound stethoscope' is~     rapidly moving from theory to reality.~      Since 1993 surgeon-performed US came to the attention at 79th Annual Clinical Congress of~     the American College of Surgeons. Nowadays USS was extended successfully to other acute~     settings, and in several USA residency programs and several EU countries, bed side imaging~     is included in the training curriculum or as stand alone competence for non radiological~     medical practitioners.~      Alas it is still not the norm across EU or the entire USA despite studies that proved its~     usefulness.~      As an example, currently in Ireland surgeon performed US is not a popular skill. The present~     paper proposes to address this issue at a larger scale than present studies, which tend to~     be confined on a limited number of patients and hospitals and different approaches.~     Currently, the European Society for Trauma & Emergency Surgery® provides modular USS courses~     that imbue surgeons with necessary skills to perform bedside US for conditions like trauma~     (FAST scan), acute cholecystitis. Also this paper aims to leap forward, for the more skilled~     ultrasonographers in diagnosing and classifying diverticular disease.~      The paper will be divided in two parts, the general part (with an extensive literature~     review and basic science and gestures for US performing) while the second part will be the~     original research.~      The closing remark is that by learning and doing these procedures the surgeon performing USS~     doesn't undermine his/her radiologist colleague's authority and skill. The big picture is~     that some basic tasks are transferrable and if used in an appropriate and methodical manner~     the final common goal - the benefit of the patient - is readily achieved.~   "
28633|NCT02682355|"~     Polymyxin B is already being used extensively in the USA and other parts of the world; its~     use is likely to rapidly increase due to the greater burden of infections caused by MDR~     Gram-negative bacteria and the growing awareness of the limitations inherent in the clinical~     pharmacology of CMS/colistin. Cross resistance exists between the two polymyxins and thus~     both must be dosed optimally; but the recently generated scientifically-based dosage~     regimens for CMS/colistin cannot be extrapolated to polymyxin B. It is essential that an~     adequately powered study is conducted to define the clinical PK/PD/TD relationships of~     polymyxin B and identify, using next-generation proteomics, biomarkers for early detection~     of kidney injury. This will allow the development of scientifically-based dosage regimens~     for various categories of patients and an adaptive feedback control clinical tool for~     optimized dosing of polymyxin B in future individual patients.~   "
28634|NCT02682342|"~     In this study, the investigators will test the hypothesis that acute in vivo exposure to~     hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive~     oxygen species production (ROS) production in human arterial endothelial cells.~   "
28635|NCT02682329|"~     To determine the effectiveness of combining different concentrations of hydrogen peroxide~     and carbamide used during tooth bleaching.~   "
28636|NCT02682316|"~     The purpose of this study is to compare any good and bad effects of using the Prevena~     Incision Management System to using the usual standard dry gauze approach. The Prevena~     Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a~     portable vacuum device made of a sponge-like foam that is applied over your incision to help~     draw fluid and debris out after surgery.~   "
28637|NCT02682303|"~     Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on~     balance control in subjects with chronic ankle instability.~      Material and methods: Twenty-eight individuals successfully completed the study protocol, of~     whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were~     assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure~     postural sway we used computerized dynamic posturography with Sensory Organization Test and~     Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the~     composite Sensory Organization Test score, the composite Sensory Organization Test strategy~     and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the~     centre of gravity sway velocity with open eyes and close eyes during the US test.~   "
28638|NCT02682290|"~     This is a proof of concept study. The aim of this study is to assess a device measuring~     rheological properties of human sputum of four populations :~        -  10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)~        -  10 patients with asthma~        -  10 patients with cystic fibrosis~        -  10 healthy volunteers.~   "
28639|NCT02682277|"~     The polyglucosamine, specification L112, is a medical device and in this clinical trial used~     for weight reduction in moderately obese participants following a long term treatment~     lasting 12 months. The rationale for this study is to show that overweight can be reduced by~     taking 2 times daily 2 tablets with the main meals.~   "
28640|NCT02682264|"~     The primary objective of this study is to determine the long-term safety of CB-03-01 cream,~     1% applied twice daily for an additional nine months in study participants with acne~     vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12~     months.~   "
28641|NCT02682251|"~     An interventional study to empower congestive heart failure patients who have a cardiac~     resynchronization therapy-cardiac implantable electronic device (CRT-CIED) by using a~     personal health record (PHR) to directly message them their device data and send alerts~     based on percent left ventricular pacing.~   "
28642|NCT02682238|"~     To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle~     (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.~   "
28643|NCT02682225|"~     The primary objective of this study is to evaluate the abuse potential of intranasal~     esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in~     nondependent, recreational polydrug users of perception-altering drugs.~   "
28644|NCT02682212|"~     The main objective is to investigate effects of perineal trauma at birth on women´s health~     and whether early physiotherapy improves pelvic floor strength. This will be achieved by an~     acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women~     with symptomes of urinary incontinence according to the questionnaire will be offered~     participation in a single-blinded randomized intervention study to compare outcome after~     targeted physiotherapy with conventional advice and support. Intervention encompasses weekly~     pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information~     collected before and after intervention and 12 months postpartum in both groups.~      Pelvic floor problems after delivery are common and often persistent, including~     urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce~     QoL and handicap women in multiple ways, physically, psychologically and socially. More~     knowledge of whether interventions and guidelines in this field can improve health and QoL~     is required.~   "
28645|NCT02682199|"~     The goal of this prospective observational study is to investigate whether whole brain~     radiation leads to measurable xerostomia from parotid gland toxicity.~   "
28646|NCT02682186|"~     Breast augmentation is among the most popular surgical procedures performed in the world~     with approximately 1,773,584 performed in 2013. This surgical intervention generates~     important pains during postsurgical recovery. A multimodal analgesia, based on the~     recommendations is proposed to the patients .The pectoral nerve block is an innovative~     technique of locoregional anesthesia that has already been successfully used in breast~     surgery. Its realization is fast, simple, and it would be superior compared with a~     paravertebral block within the framework of mastectomy. The interest of this technique has~     never been assessed in esthetic breast surgery. The aim of this study is to evaluate the~     analgesic efficacy of the association of  Pecs blocks 1 and 2  on pain intensity after~     breast augmentation surgery.~   "
28647|NCT02682173|"~     Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in~     the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat~     distribution in the liver has so far been studied with liver biopsies and single voxel MR~     techniques. With this trial investigators present a new, whole organ MR-quantification of~     liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.~   "
28648|NCT02682160|"~     The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily~     protein intake in obese patients who underwent a bariatric surgery (in the 3 months~     following surgery).~   "
28649|NCT02682147|"~     This study will use dual energy x-ray computed tomography (DECT) to evaluate the~     relationship between heterogeneous perfusion, hypoxia (low oxygen in inspired gas) and~     induction of pulmonary vascular dilatation to characterize emphysema susceptibility in a~     normal smoking population. The investigators will correlate DECT measures of perfusion with~     lung injury measured by single photon emission computed tomography (SPECT). The~     investigators will study the effect of pulmonary arterial vasodilation to see if it~     eliminates indices of persistent lung injury in smokers that are susceptible to emphysema~   "
28650|NCT02682134|"~     The aim of this interventional study is to find out the incidence of sore throat among~     intubated patients in Jordan university hospital and to find out which is preventive and~     effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as~     lubricant versus dexamethasone 8 mg intravenously or both.~   "
28651|NCT02682121|"~     Diabetes mellitus (DM) imposes an approximate 2-fold increased risk of atherothrombosis.~     Patients with type 2 DM have a 2- to 4-fold increase in the risk of coronary artery disease~     (CAD) and atherothrombotic complications. Current evidence indicates that altered platelet~     function and reactivity are key determinants of arterial and venous thrombosis in~     metabolic syndromes. In addition, venous thrombosis and pulmonary embolism are associated~     with increased body mass index, a common feature of type 2 DM and the metabolic syndrome.~     Altered platelet behavior, function, and phenotype may be critical factors in these~     thrombotic complications as well. The mechanisms that lead to altered phenotype and function~     of platelets in DM, and that underlie heightened contributions of platelets to thrombotic~     complications in type 2 DM, are nevertheless incompletely understood. In this project, the~     investigators will prospectively determine if clinical intervention with metformin--a~     commonly-used therapeutic agent that reduces blood glucose, promotes weight loss, and~     improves lipid profiles--reverses platelet reprogramming and hyperreactivity in obese~     subjects with impaired fasting glucose and thus, at-risk for type 2 DM.~      In addition to metformin, all participants will be given lifestyle modification (LSM)~     education on diet and physical activity, followed by guidance on how to adhere to the LSM,~     depending on random assignment to intervention group (education only (n=26) vs.~     implementation intentions alone (n=27) vs. implementation intentions with partner (n=27)).~     The LSM coaching for different intervention groups will allow the investigators to test~     whether there are more effective ways for adherence than others. Participants in these three~     LSM intervention groups will be further randomized to either Metformin (n=40) or Placebo~     (n=40), such that participants in the three LSM groups will be randomly and evenly~     distributed across the two study medication groups.~   "
28652|NCT02682108|"~     Several noninvasive radiological techniques have been investigated for the diagnosis of~     liver fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or~     hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly~     appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate~     the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of~     liver fibrosis.~   "
28653|NCT02682095|"~     The purpose of the study is to get an understanding about what problems patients with~     hypertension are facing, how they manage these challenges, how they feel and what~     requirements they believe are important to have in their treatment. These factors will later~     act as a foundation and incentive for designing an intervention that may result in more~     patients achieving blood pressure control with maintained quality of life.~   "
28654|NCT02682082|"~     The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with~     Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable~     pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea,~     excessive sedation, constipation).~   "
28655|NCT02682069|"~     This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest~     Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are~     receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an~     adjunctive tool in the assessment of the wound and will be used to guide the targeted~     sampling of a wound (punch biopsy method).~   "
28656|NCT02682056|"~     This study will compare three glucose measurement techniques among diabetic children and~     adolescents. The study seeks to determine if a hydrogel microneedle patch, versus a lancet~     or intravenous catheter, would be a preferable option for monitoring glucose levels among~     the diabetic pediatric population.~   "
28658|NCT02682030|"~     The investigator is examining the use of one airway clearance medical device compared to the~     use of two airway clearance medical devices together in patients with amyotrophic lateral~     sclerosis (ALS). More specifically, the investigator wants to know how effective the use of~     either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use~     of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist~     together to maintain a healthy airway and clear secretions.~      The first device is a passive form of mechanical High Frequency Chest Compression (HFCC),~     which was designed to help clear the airway of mucus and other secretions through mechanical~     knocking of the chest area. The second device, called a Cough Assist, aids patients to clear~     mucus and secretions that they would otherwise be unable to clear with coughing. This study~     will enroll up to 20 people in total at CSMC.~   "
28659|NCT02682017|"~     Red meat makes a significant contribution to the human diet. The most widely consumed meat~     globally is pork which accounts for 36% of overall meat intake with beef and poultry~     contributing 22% and 35%, respectively. Pork meat provides a range of important nutrients~     including protein, zinc, B-vitamins and a range of important minerals however there is~     accumulating evidence to suggest that consuming red meat and processed meat increases the~     risk of cardiovascular disease (CVD) and colon cancer. Despite these reports of a negative~     impact on health, global pork consumption continues to increase and there are increasing~     efforts to improve the nutritional profile of pork meat through the development of novel~     porcine feed regimens. The manipulation of pig feed to produce 'healthier' meat and meat~     products offers a feasible approach to reduce the risk of preventable disease. Furthermore,~     recent projections of an increased global demand for pork and poultry, particularly in~     China, have highlighted the increasing strain that will be placed on the supply of grains~     and the need to find alternative and sustainable feed ingredients. Macroalgae is emerging as~     a potential sustainable source of novel bioactive ingredients for the animal feed industry~     with some species known to be a good source of protein, minerals, polyunsaturated fatty~     acids and a range of fibre components including fucoidan and laminarin.~      The polysaccharides, laminarin and fucoidan, which are found in abundance in brown seaweed,~     are gaining increasing attention as a potential bioactive feed ingredients with putative~     antioxidant, anti-inflammatory and immunomodulatory activities. Incorporation of a~     laminarin/fucioidan mix (LAM/FUC) into the porcine diet was shown to result in lower levels~     of lipid oxidation in fresh pork steaks. Numerous studies to date have also investigated the~     health promoting effects of LAM/FUC through modulation of the porcine gut microbiota which~     was shown to enhance inflammatory cytokine expression in response to pathogen recognition~     and also to increase piglet performance post weaning.~      The uptake and fate of fucoidan in humans remains unknown albeit after consumption,~     unaltered fucoidan has been detected in human plasma after ingestion suggesting at least~     partial bioavailability of this compound. A study by Moroney et al. (2015) using an in vitro~     bioavailability Caco-2 model provided indications that fucoidan was bioavailable and that it~     may have potent antioxidant potential.~      The primary aim of this randomised parallel placebo controlled human intervention trial was~     to investigate if consuming pork meat from pigs supplemented with a LAM/FUC mix, in addition~     to their normal diet, would impact on blood oxidant and inflammatory status of healthy~     adults. The secondary aim was to determine the effect of consuming LAM/FUC fed pork meat on~     lymphocyte DNA damage, lipid status and immune function in healthy adults.~   "
28660|NCT02682004|"~     After vaginal delivery, all of the participants will evaluate by using Edinburg depression~     scale and venous blood sample will obtain. Postpartum depression will consider the result of~     scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin~     level will compare between depressed and nondepressed women.~   "
28661|NCT02681991|"~     Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic~     renal failure.~      120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).~      Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum~     indoxyl sulfate will be evaluated.~   "
28662|NCT02681978|"~     This study evaluates the effect of ivabradine on endothelial function in patients with~     coronary artery disease (CAD) after complete revascularization with percutaneous coronary~     angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive~     ivabradine 5 mg twice daily or to continue with standard medical therapy.~   "
28663|NCT02681965|"~     Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC~     breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical~     activity, and 4)quality of life in women randomized to receive the modified LEAN~     intervention compared to women randomized to wait-list control (i.e., the wait-list control~     will receive the modified LEAN intervention after completing the 6-month study).~   "
28664|NCT02681952|"~     A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical~     Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and~     Kremezin in Pre-dialysis Patients With Chronic Renal Failure~   "
28665|NCT02681939|"~     This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and~     biochemical parameters in young overweight and obese subjects. Thirty overweight/obese~     volunteers will be divided into two groups. The first group will receive no intervention.~     The second group will be supplemented with one capsule of Tulsi orally every morning and~     evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be~     evaluated before and after the intervention.~   "
28666|NCT02681926|"~     Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A~     novel technology was recently developed to allow an automatic points annotation when~     indirect parameters of lesion formation reach predefined target values.~      The aim of the study was to evaluate, in a prospective and multicenter study, the safety,~     efficiency and PVI effectiveness of a new ablation tracking tool (VISITAG; Biosense Webster)~     during paroxysmal AF ablation using a contact force sensing catheter.~   "
28667|NCT02681913|"~     Myocardial protection is a major issue in cardiac surgery, since inadequate protection~     increases the risk of postoperative cardiac dysfunction. The main principle of myocardial~     protection in cardiac surgery is to preserve myocardial function by preventing ischemia with~     blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood~     cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is~     already used as standard care as an initial cardioplegic bolus in minimally invasive port~     access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia,~     has an added value remains unclear. Therefore the investigators would like to investigate~     the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in~     patients scheduled for minimally invasive, port access operations (mitral valve surgery).~      Half of the participants will receive standard intermittent warm blood cardioplegia, while~     the other half will receive intermittent warm blood cardioplegia enriched with adenosine.~   "
28668|NCT02681900|"~     This study tests the effects of a self-affirmation manipulation on (i) acceptance of a~     health message detailing the risks of alcohol consumption, (ii) engagement with the health~     message and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete~     a self-affirmation manipulation, where they reflect on their most important values, whereas~     the other half complete a control equivalent, where they reflect on their least important~     values. Immediately post-intervention, all participants then receive information about the~     risks of alcohol consumption and complete measures of message acceptance and engagement with~     the materials. Seven days after intervention, participants self-report their alcohol~     consumption in the previous 7 days.~   "
28677|NCT02681783|"~     The presence of Pigment Epithelial Detachments (PEDs) in neovascular Age-related Macular~     Degeneration (nAMD), Central serous chorioretinopathy (CSR) and idiopathic Poplypoidal~     Choroidal Vasculopathy (iPCV) can present a diagnostic challenge in the elderly population;~     despite detailed diagnostic testing to differentiate these three conditions, misdiagnosis~     and mistreatment still occurs. One potential way of differentiating these three conditions~     might be to compare cytokine profiles in nAMD versus CSR versus iPCV. This information may~     be useful in creating a diagnostic aqueous cytokine and hormone profile to differentiate~     between nAMD, CSR and iPCV.~      The primary goal of this study is to compare baseline aqueous cytokine and cortisol levels~     between nAMD, CSR, and iPCV patients and age-matched cataract controls. The secondary~     objective is to assess intra-group changes in visual and anatomical outcomes in nAMD, CSR~     and iPCV patients with PED treated with aflibercept and correlate these changes to baseline~     cytokines. We will not be comparing visual and anatomical changes between groups after~     treatment in this study.~   "
28748|NCT02680821|"~     Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate~     ligament (ACL) revision will have a better rotational knee stability and therefore better~     patient reported outcome measure (PROM) scores compared to patients, who have ACL revision~     surgery without ALL reconstruction.~   "
28669|NCT02681887|"~     In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity~     (BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive~     either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour~     before bed. The investigators will assess melatonin's effect on insulin sensitivity by~     performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured~     using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating~     melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal~     blood pressure, and potential intermediates including endothelial function using brachial~     ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion,~     and renin-angiotensin system activation using measurements of plasma renin activity,~     angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate~     melatonin supplementation's effect on cellular cytokine and CC family chemokine expression~     as well as high sensitivity C-reactive protein, IL-6, and TNF-α.~      There will be a 24 week cohort phase as an extension of the trial. This will be an~     open-label prospective study of 50 subjects recruited from the trial who will take 2 mg of~     controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At~     the end of the cohort-phase (36 weeks after entry in the trial), the investigators will~     again assess the extended use of melatonin supplementation on 24-hour BP, and glycemic~     control (HbA1, fasting glucose).~   "
28670|NCT02681874|"~     Many behavioral interventions designed to improve dietary patterns for ethnic and~     racial/minority preschoolers have produced modest outcomes. A limitation of these~     interventions include a failure to address key factors associated with dietary patterns for~     these children, such as parental stress levels. Therefore, the identification of~     intervention models that target these factors and are effective, acceptable, and feasible~     among parents of young minority children is important.~      Subjects will be asked to take part in this study because they are the parents of a child~     that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being~     done and their child's body mass index has been at or above the 85th percentile.~      The purpose of this pilot study is to assess the ease and acceptance of providing an~     intervention for parents of children ages 2-5 years in the pediatric primary care clinic.~     The purpose is to also assess how well the intervention works in improving the child's~     dietary patterns.~   "
28671|NCT02681861|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and~     female subjects.~      This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous~     doses and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered~     intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF);~     explore a potential gender difference in safety, tolerability and pk of single intravenous~     dose and single sc doses administrations of ASP6294 as well as determine the maximum~     tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.~      Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.~   "
28672|NCT02681848|"~     Introduction: Smoking is a major avoidable cause of ill-health and premature death.~     Treatments that help patients successfully quit smoking have an important effect on health~     and life expectancy. Varenicline is a medication that can help smokers successfully quit~     smoking. However, there are concerns that it may cause adverse effects, such as increase in~     the occurrence of depression, self-harm and suicide and cardiovascular disease. In this~     study the investigators aim to examine the effects of varenicline versus other smoking~     cessation pharmacotherapies on smoking cessation, health service use, all-cause and~     cause-specific mortality and physical and mental health conditions.~      Methods: In this project the investigators will investigate the effects of varenicline~     compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether~     these effects differ by area level deprivation; and (2) the following clinically-important~     outcomes: rate of general practice and hospital attendance; all-cause mortality and death~     due to diseases of the respiratory system and cardiovascular disease; and a primary care~     diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study~     is based on a cohort of patients prescribed these smoking cessation medications from the~     Clinical Practice Research Datalink (CPRD). The investigators will use three methods to~     overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox~     regression, and instrumental variable regression. The total expected sample size for~     analysis will be at least 180 000. Follow-up will end with the earliest of either an 'event'~     or censoring due to the end of registration or death.~      Ethics and dissemination: Ethics approval was not required for this study. This project has~     been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). The~     investigators will disseminate the findings via publications in international peer-reviewed~     journals and presentations at international conferences.~   "
28673|NCT02681835|"~     We therefore designed this randomized crossover study to compare C-MAC with Macintosh~     laryngoscope in emergency intubation performed by paramedics according to three different~     intubator positions.~   "
28674|NCT02681822|"~     To study the impact of genetic and environmental factors on high-level cognition associated~     neural circuits among healthy young Chinese Han subjects.~   "
28675|NCT02681809|"~     The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal~     injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe~     non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment~     (PVD) in order to reduce the risk of disease progression to proliferative diabetic~     retinopathy (PDR).~   "
28676|NCT02681796|"~     The rationale for this study is to investigate the benefits of epidural analgesia in~     pancreatic resections in a prospective, single blind, randomized control trial. This study~     will evaluate both short and long-term outcomes related to epidural analgesia, providing a~     longitudinal and comprehensive perspective to the advantages and disadvantages of this~     technique. The investigators hypothesize that the use of epidural analgesia reduces a~     patient's consumption of morphine or morphine-equivalent in the post-operative period~     following pancreatic resections.~   "
28678|NCT02681770|"~     Following solid organ transplantation, adherence to treatment regime (especially with regard~     to a reliable intake of immunosuppressant medication) is crucial for transplant survival,~     and has an impact on the patients' health and morbidity. Approximately 35 % of graft~     rejection or failure cases in kidney transplant patients are due to insufficient levels of~     adherence or non-adherence to immunosuppressant medication. Adherence is influenced by both~     individual and interpersonal aspects in complex interaction.~      This study aims at investigating individual and dyadic functioning of both patients and~     their spouses following kidney transplantation. Outcome measures of interest are patient's~     level of adherence and both patient and spouse's subjective quality of life.~   "
28749|NCT02680808|"~     Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using~     midazolam as a probe. Twenty healthy male subjects will participate~   "
28679|NCT02681757|"~     The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated~     Adaptic gauze when used with the soft cast technique to assess overall time to healing,~     yeast infection rate and parents perception of pain level at time of dressing change on a~     scale of 1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique~     improves wound healing in pediatric partial to deep partial thickness hand and foot burns by~     decreasing the length of healing time, decreasing the risk of yeast infection, and~     decreasing pain associated with dressing changes.~   "
28680|NCT02681744|"~     The purpose of this study was to examine the effects of resistance training on sarcopenic~     obesity in older women.~   "
28681|NCT02681731|"~     Through a series of sequential analyses, retrospective database exploration looking for~     linkages and associations between the use of processed electroencephalogram (EEG) and/or~     cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be~     explored.~   "
28682|NCT02681718|"~     The purpose of this study is to compare the efficacy of three approaches in diabetes~     management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual~     hospital-based care. The goal is to determine the most cost-effective method of diabetes~     management among an economically-disadvantaged, minority population.~   "
28683|NCT02681705|"~     This phase II trial is studying giving radiation therapy together with combination~     chemotherapy after surgery to see how well it works in treating children with newly~     diagnosed medulloblastoma.~   "
28684|NCT02681692|"~     Colonoscopy is widely considered as the main choice for patients with suspected colorectal~     disease,and for screening those at high risk of colorectal cancer. However， colonoscope~     examination,especially those usedated ones for screening,may bring much pain to~     patients,even induce some severe complications such as peforation.Considering the increasing~     need of colonoscopy examination for screening purpose,it has been a problem deserving of~     futher study that how to reduce pain and ensure safety during the procedure.Some studies~     suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to~     ease patient discomfort and reduce complications.Theoretically,the MEI could accurately~     depict the position of the scope in three dimensions and help avoid forcefully feeding the~     colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting~     procedure safety.However,the problem whether MEI system could help reduce patient pain~     during procedure effectively，especially in inexperienced colonoscopists，still remains~     controversial for reseachers,and no study has been designed to test the hypothesis that MEI~     may help decrease the risk of some complications,such as colon perforation.In this study we~     aim to evaluate the he efficacy of magnetic scope navigation on patient pain during~     ussedated colonoscopy；In addition，we try to construct a simple colon force measurement~     device ,and by using this device to observe the variation of force exerted on colon loop ,we~     expect to find the potential mechanism of pain-alleviation and explore the possible effect~     of complication reduction during colonoscopy under the influence of MEI system.~   "
28685|NCT02681679|"~     Since a new generation of femtosecond lasers became available for cataract surgery in 2009,~     the use of this image-guided system has provided several benefits, including a reduction in~     phacoemulsification energy by prefragmentation of the crystalline lens, and the potential~     advantages of more precise corneal incisions and capsulotomy formation. However, as with any~     new surgical technique, femtosecond laser cataract surgery also has potential complications.~     Intraoperative miosis is one of the most common intraoperative complications of femtosecond~     laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8~     Significant pupillary constriction necessitates the removal of the anterior capsule flap,~     fragmented nucleus and remaining cortex, which is potentially associated with a higher rate~     of surgery-related complications.~   "
28686|NCT02681666|"~     This pilot study will be a randomized parallel trial comparing Mindfulness-Based Irritable~     Bowel Syndrome Eating Awareness Training done over an 8 week period to a standard low~     Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet.~   "
28687|NCT02681653|"~     Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome~     wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial~     syndrome merely blocking one of the various inflammatory pathways may not suffice to provide~     effective treatment and this may partly explain why most of the adjunctive therapies~     developed for severe sepsis have yielded disappointing results in rigorous clinical trials.~     Statins have varied pleiotropic effects on the inflammatory mediators and there addition to~     the current adjuvant therapies in septic shock may help in reduction of mortality. The~     present trial aims to study survival benefit and changes in bio-marker levels in septic~     shock.~      Adult patients (>=18 years) in septic shock and admitted to ICU will be included in the~     study. Patients will be randomized as per computer generated random number into the Drug~     (Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected~     patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the~     trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained~     blinded to the study group assignment throughout the trial.~   "
28688|NCT02681640|"~     The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node~     metastases in breast cancer.~   "
28689|NCT02681627|"~     There is increasing amount of evidence which suggests that miscarriage is related to a~     primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that~     endometrial scratch improves live birth in women who underwent IVF.~      The aim of the study is to find out if scratch of the endometrium prevents recurrent~     miscarriage.~   "
28690|NCT02681614|"~     This clinical research study tests the Uronav system. Patients with prostate cancer will be~     asked to take part in this study.~      Uronav system is an investigational device that is used on this study to help place markers~     in the patient. These are called fiducial markers and they are placed in the patient to help~     plan radiation treatment. Radiation therapy treatment will be planned by the treating~     physician and will not be experimental or part of this research study.~      This study will also test the similarities and differences of biopsy tissue structures and~     the findings from the intraprostatic MRI (internally guided MRI).~   "
29272|NCT02673996|"~     Objective: In this pilot study, we will test the hypothesis that patients with POTS (age~     18-60 years) will have a higher percentage of functional antibodies to adrenergic receptors~     compared with control subjects without POTS.~   "
28694|NCT02681562|"~     Treatment selection for breast cancer is still largely empiric and guided by large~     randomized clinical trials on populations of patients. This approach is inadequate for the~     selection of individualized chemotherapy regimens. Estimates of benefits for individuals are~     extrapolations from the effects seen in these large trials, and do not necessarily apply to~     individual patients. The revolution in genomics promises to transform oncology care. By~     better defining cancer subtypes, a better understanding of breast cancer biology should help~     to guide treatment.~      The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a~     targeted therapeutic drug such as olaparib wich also requires development of new biomarkers~     which may be useful for future studies. With this approach it could be possible to~     demonstrate drug target or biomarker effect in clinical setting and models the relationship~     between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach~     include the following:~        -  It could facilitate rational drug selection, identify therapeutic failures early, and~          compress timelines for anticancer drug development.~        -  It could provide initial rationale and guiding principles for further drug development~          based on studies in humans (rather than xenografts, where tissues of one species are~          transplanted to another species).~        -  As it focuses on extensively characterizing how a drug works and whether it hits its~          intended target (including molecular imaging studies) in a limited number of patients~          it could yield results that would optimally inform and expedite the subsequent~          development of molecularly-targeted agents~   "
28695|NCT02681549|"~     The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination~     with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to~     determine activity and safety of the drug combination. Furthermore, in patients who undergo~     resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of~     treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral~     specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue~     when available.~      A total of 53 eligible patients will be enrolled on this trial (20 with melanoma and 33 with~     NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed~     in the first stage of that cohort. The study will accrue for approximately 24 months, and~     will be open for approximately 12 additional months as patients on study are being followed.~   "
28696|NCT02681536|"~     The study is performed to compare the outcomes of two stimulation protocols, the minidose~     long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.~   "
28697|NCT02681523|"~     A single centre, single arm phase II study of alternating eribulin and hormonal therapy in~     12 patients with locally advanced or metastatic breast cancer who have received at least one~     hormonal therapy and at least one chemotherapy in the metastatic setting.~   "
28698|NCT02681510|"~     This study will focus on enhancing future smoking cessation treatment effectiveness by~     piloting a potentially more powerful combination of three FDA-approved pharmacotherapies:~     varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment~     (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the~     design of future studies that would use this combination treatment as a cessation tool~     within the chronic care arsenal of treatments.~   "
28699|NCT02681497|"~     This study is a retrospective chart review study aiming to assess the characteristics and~     health outcomes of patients with type 2 diabetes treated with canagliflozin when used in~     addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort~     of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for~     future longitudinal studies that investigate outcomes over a longer follow-up period, and~     whether canagliflozin (when used in addition to insulin therapy) has an impact on~     diabetes-related healthcare costs.~   "
28700|NCT02681484|"~     Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate~     variability (HRV) and heart rate - respiration coordination in healthy volunteers. This~     study was performed to learn more about such improvements and possible alteration in~     baroreflex sensitivity (BRS) in hypertensive patients, which characteristically differ in~     those regulatory parameters from normotensive patients~   "
28701|NCT02681471|"~     Aim of this prospective clinical study was to compare two different surgical techniques and~     used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate~     (TURP) syndrome undergoing TURP.~      Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical~     study. Patients were included one of two groups (Group Monopolar and Group Bipolar).~   "
28702|NCT02681458|"~     The purpose of this study was about survey of prevalence of fungal infections among drug~     users referring to methadone wards of Hospitals in northeast region of Iran~   "
28703|NCT02681445|"~     The purpose of this pilot study is to evaluate the sensitivity and specificity of a~     nanotube-based point-of-care breath-based tuberculosis screening test as compared to the~     current standards of care including sputum microscopy, sputum culture, chest X-ray, and~     GeneXpert (MTB/RIF).~      The primary objective is to determine an initial estimate of the sensitivity and specificity~     of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary~     tuberculosis.~      Secondary objectives include the collection of user data to test and further develop the~     screening platform based on end-user feedback.~   "
28704|NCT02681432|"~     Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia~     intraperitoneal chemotherapy with paclitaxel in ovarian cancer.~   "
28705|NCT02681419|"~     This study evaluates two different methods of controlling intraocular pressure in nonvalved~     aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.~   "
28706|NCT02681406|"~     Investigators will recruit 280 alcohol dependent patients in treatment programs in the~     Philadelphia area to test the efficacy and cost efficiency of a smartphone based application~     for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC).~     Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6~     months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.~   "
28750|NCT02680795|"~     This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of~     belinostat in patients with relapsed/refractory solid tumors or hematological malignancies~     who have heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled~     patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype~   "
28707|NCT02681393|"~     It is essential that individuals living with stroke engage in physical activity to improve~     cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This~     objective of this study is to examine the effectiveness of an educational brochure that~     promotes exercise in people with stroke, combined with a motivational telephone support, on~     maintaining physical activity. Fifty participants with stroke will be enrolled. This study~     will provide insight into implementing effective tools that are designed to help individuals~     with stroke maintain physically active behaviours in the long-term.~   "
28708|NCT02681380|"~     Empathy is an important skill to learn for medical student. However, learning empathy remain~     difficult. The investigators aim was to assess the efficacy of a specific training, Balint~     like, on the empathy abilities of medical students in the 4th year. The investigators~     planned a randomized controlled trial in 3 universities.~   "
28709|NCT02681367|"~     This is the first study to investigate, whether pregnancy and implantation rates would~     improve in patients with recurrent implantation failure (RIF), if all embryos were to be~     frozen and transferred in a consecutive natural cycle.~   "
28710|NCT02681354|"~     Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual~     tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality),~     institutionalized elderly people with MCI will relearn dual tasks in combination with~     balance. Afterwards, the transferring effect on gait in general, balance and cognition will~     be examined.~   "
28711|NCT02681341|"~     The primary objective of this study is to confirm that properties of CardioCel provide~     operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine~     pericardium not treated with proprietary ADAPT engineering.~   "
28712|NCT02681328|"~     The purpose of this study is to compare the performance of Afirma GEC and ThyroSeq v.2 in~     indeterminate thyroid nodules to determine which test can allow more patients to avoid~     unnecessary surgery and preserve quality of life.~   "
28713|NCT02681315|"~     This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6~     liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates~     of extubation failure in mechanically ventilated preterm infants.~   "
28714|NCT02681302|"~     The goal of this study is to determine the safety and clinical effect of combined checkpoint~     inhibition administered after autologous hematopoietic stem cell transplantation in each of~     six clinical cohorts of high risk and recurrent disease. In addition to assessing the~     incidence and severity of adverse events and rates of complete response and progression free~     survival, investigators intend to monitor immune reconstitution, phenotype and TCR~     repertoire throughout treatment and at the time of disease progression. Investigators will~     also analyze the gut microbiome prior to conditioning, throughout treatment, post-transplant~     and at time of relapse.~   "
28715|NCT02681289|"~     Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned~     to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application~     between preterm and term at-risk infants.~   "
28716|NCT02681276|"~     Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium~     Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment.~      Methodology: Consecutive patients referred to a specialist clinic of endodontics are~     randomly assigned to have the root canal treatment performed with a concomitant irrigation~     either with a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or~     necrotic pulps and retreatment cases were included. Root canal treatment procedures varied~     but followed the routines of the Specialist Clinic of Endodontics, Public Dental Health,~     Gothenburg, Sweden. Immediately before the root canal filling a microbial sample is taken~     from the operative field and the root canal. The bacterial samples were processed at the~     laboratory as outlined by Möller (1966). After each visit each patient was instructed to~     fill in a questionnaire and assess his or her post-operative pain on a visual analogue scale~     (VAS), with endpoints 0= no pain and 10= worst imaginable pain, for seven consecutive~     days. The Fischer's exact test was used for statistical analyses of the differences in~     outcome between the groups.~   "
28717|NCT02681263|"~     The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI~     requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing~     Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study~     will describe and support the use of high dose (6g/day) of temocillin which could be of~     interest for the treatment urinary tract infection due to multi-resistant bacteria having~     high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by~     monitoring the adverse event and the incidence of eventual Clostridium difficile associated~     infection.~   "
28718|NCT02681250|"~     A Randomized controlled Clinical trial including 96 patients in which aim is to investigate~     the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional~     titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two~     types of implants.~   "
28719|NCT02681237|"~     This is a proof of concept study (a study to initially assess the benefit a new drug~     indication) of the combination of two investigational drugs cediranib and olaparib in~     patients with ovarian cancer whose cancer worsened despite previously receiving a poly~     (ADP-ribose) polymerase (PARP) inhibitor (such as olaparib).~      The purpose of this study is to find out whether taking cediranib and olaparib at the same~     time will be able to stop tumors from growing further or shrink it.~      Cediranib works by blocking (inhibiting) several specific proteins in cancer cells called~     the vascular endothelial growth factor (VEGF) receptors. These proteins are important in the~     formation of blood vessels to the tumor. It is believed that many tumors survive because the~     blood vessels on the tumors bring oxygen and nutrients to the cancer cells which enable them~     to grow. If the formation of the blood vessels is blocked, the tumor cells may die.~      Olaparib, works by blocking a protein called poly [adenosine diphosphate-ribose] polymerase~     (PARP). PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA,~     molecules that contain important instructions for the development of cells). Many cancers~     are thought to develop from damaged DNA. By blocking PARP from fixing damaged DNA, the tumor~     cells may die.~      Adding cediranib to olaparib, and therefore blocking several different mechanisms for cancer~     growth, may stop tumor growth.~   "
28720|NCT02681224|"~     A single site, double-blind, randomized, placebo-controlled, clinical study comparing the~     difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.~   "
28723|NCT02681185|"~     The study's goal is to promote accessible and cost-effective diabetes care through~     electronic means. Underserved populations including rural areas do not have diabetes~     specialists. Previous study data has shown the effectiveness of Internet communication in~     lowering a patient's Hemoglobin A1C, a measure of blood sugars, closer to the target number.~     The investigators thus wish to test the effectiveness of diabetes care provided by virtual~     means, including virtual consultations, online monitoring of blood sugars, diabetes~     education via web-based videos, and support/advice provided through phone or email by an~     Endocrinologist. The goal is to test if virtual care is a viable means to extend care for~     diabetes to underserved populations.~   "
28724|NCT02681172|"~     This phase 4 study will explore, in the context of the present French clinical practice, the~     impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for~     etiologic determination of the cognitive and functional impairment, but in whom:~        1. lumbar puncture was not feasible for medical conditions~        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating~          physicians~        3. lumbar puncture was refused by the patient~   "
28725|NCT02681159|"~     Critical incidents in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients. Most of the studies in this regards~     are retrospective with many drawbacks and pitfalls like absence of information in the~     records of the patients.~      In the investigators' study, the investigators will follow the critical incidents among~     patients who underwent surgery under anesthesia whether regional or general over the next~     two years from 2016 to 2018, by examining the patients records from the hospital database~     and recording the events that occur to the patients.~   "
28726|NCT02681146|"~     A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks.~     The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with~     unidirectional cross-over ( from control to experimental ) but with randomisation of when~     each cluster undertakes this transition. In the stepped-wedge design, there is a staggered~     roll-out of the intervention, where the time and hence the sequence of units (clusters) that~     will start the intervention at each period is determined by random allocation.~      The randomisation occurs before the start of the trial. All clusters start the trial in a~     control phase with no intervention being delivered at any site, then sequentially cross over~     from the control group to the intervention group, until all sites are receiving the~     intervention. Outcomes are measured on the study participants in all clusters at every time~     period, hence measurement of outcomes takes place at each step in the wedge; each cluster~     provides data points in the control and intervention conditions allowing each site to act as~     its own control.~   "
28727|NCT02681133|"~     The primary purpose is to evaluate the level of physical activity in patients with knee~     osteoarthritis in a spa treatment and doing epidemiological study about this patient.~   "
28728|NCT02681120|"~     This is a pilot, non-randomized, single institution, observational study investigating the~     effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer~     in tissue and blood as well as on imaging in women at elevated risk for breast cancer.~     Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible~     women at elevated risk for breast cancer who are already planning to undergo bariatric~     surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and~     fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric~     surgery, and approximately 1 year after bariatric surgery.~      In parallel we will also be assessing 40 normal breast tissue specimens as well as blood~     samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI,~     elevated risk control group for our study. The KTB samples will be matched for general risk~     of breast cancer (>20%), age, race and menopausal status.~   "
28729|NCT02681107|"~     This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which~     is expected to be equally tolerated as standard whole breast irradiation (WBI) based on~     radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and~     less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and~     cosmesis at 2 years will be compared to data already collected using standard WBI in the~     Canadian RAPID trial.~   "
28730|NCT02681094|"~     The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg~     co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or~     dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin~     monotherapy.~   "
28731|NCT02681081|"~     The purpose of the study is to identify non-invasive strategies that will optimize the~     neurobiological environment and improve learning and memory in the treatment of chronic~     pain. The overall aims of the current proposal are to determine if food restriction and/or~     glucose administration in conjunction with a relaxation/guided imagery exercise will result~     in neurophysiological changes and functional improvements compared to the relaxation/guided~     imagery exercise alone.~   "
28732|NCT02681068|"~     The registry collects cases of patients received fecal microbiota transplantation (FMT) due~     to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to~     analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to~     implement a standardization of FMT in German hospitals and improve patient outcome.~     Therefore, a detailed description of completions of FMT are documented on our web-based~     survey platform www.ClinicalSurveys.net.~   "
28733|NCT02681055|"~     This is a multi-center, proof-of-principle, open-label study designed to evaluate the~     efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and~     Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.~   "
28734|NCT02681042|"~     The study cohort will consist of up to 50 patients who are candidates for Left Atrial~     Appendage (LAA) closure in whom oral anticoagulation is contraindicated.~      Subjects evaluated for left atrial appendage closure will be screened for inclusion and~     consented prior to their procedure. If the anatomy is favorable for placement of the Lariat®~     device, the procedure will be performed at one of the participating centers. If anatomy is~     not favorable, the patient will be excluded from the study and managed using best care~     practices by his or her physician.~   "
29273|NCT02673983|"~     The aim of this study is to evaluate FTRD (full-thickness resection device) in terms of~     obtaining full-thickness biopsies form the gastrointestinal tract endoscopically in the~     work-up of patients with gastrointestinal motility disorders.~   "
28735|NCT02681029|"~     Recent improvements in cell culture systems have led to a shift in in vitro fertilization~     (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer.~     Blastocyst culture and transfer could theoretically provide better synchronization between~     the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy~     rates and implantation rate following transfer of thawed cleavage embryos and blastocysts~     cultured from thawed cleavage embryos.~   "
28736|NCT02681016|"~     The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary~     stent Calypso (Angioline, Russia) in comparison with everolimus-eluting coronary stent~     Xience (Abbott Vascular, USA)~   "
28737|NCT02680990|"~     This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of~     Band Together, a strength-training and walking program (intervention arm) vs. education on~     the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI)~     malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant~     therapy.~   "
28738|NCT02680977|"~     In low-income areas worldwide, most patients with Parkinson's disease (PD) cannot afford~     long-term Levodopa therapy. A potential therapeutic option for them is the use of a legume~     called Mucuna Pruriens var. Utilis (MP), which has seeds with a high levodopa content (5-6%)~     and grows in all tropical areas of the world. MP powder is very cheap (total annual cost for~     a PD patient: 10-15 US $). The aim of this study is to assess efficacy and tolerability of~     acute and chronic use of MP compared to standard Levodopa therapy.~      The primary objective of this study is to investigate efficacy of acute levodopa challenge~     using MP in comparison to levodopa with a Dopa Decarboxylase Inhibitor (LD+DDCI) and without~     (LD-DDCI) and placebo.~      The secondary objectives are to investigate safety of acute intake of MP as well as efficacy~     and safety of chronic intake of MP over a 8-week period in comparison to usual LD+DDCI home~     therapy.~   "
28739|NCT02680951|"~     This study will examine the appropriate dose and side effects of dasatinib, when it is given~     with the standard of care chemotherapy for children and adolescents with Acute Myeloid~     Leukemia (AML).~   "
28740|NCT02680938|"~     The third stage is the interval between delivery of the infant and delivery of the placenta.~     This stage averages 10 minutes and is considered prolonged if it lasts longer than 30~     minutes, placental separation occurs as a result of continued uterine contractions,~     continued contractions control blood loss by compression of spiral arteries and also result~     in migration of the placenta into the lower uterine segment and then through the cervix.~      The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of~     treatment for retained placenta. Despite this recommendation, the method has yet to make its~     way into routine practice, probably because of the lack of a large substantive randomized~     controlled trial, and lingering doubts over which uterotonic to use and at what dosage.~      The purpose of this study is to evaluate the effect of intraumbilical vein injection of~     oxytocin on reducing the duration of the third stage of labor and the need for manual~     delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of~     labor and decrease incidence of rtained placenta in comparison with inraumblical injection~     of normal saline.~      This is a prospective randomized control trial conducted at Ain Shams University Maternity~     Hospital. This study included 240 term pregnant women in labor admitted to the labor ward,~     They were divided into Two groups :~      Group (A):~      The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the~     most proximal site to the placenta after clamping and cutting of the umbilical cord.~      Group (B):~      The control group, 1 mL normal saline will be injected into the umbilical vein at the most~     proximal site to the placenta after clamping and cutting of the umbilical cord.~   "
28741|NCT02680925|"~     The investigator will evaluate the influence of lung protective ventilation on postoperative~     clinical outcome in pediatric patients. The hypothesis is that application of low tidal~     volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure~     (PEEP) would be more beneficial than conventional ventilation in children.~   "
28742|NCT02680912|"~     This is a two-armed randomised controlled pilot study that investigates the component~     efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to~     receive either warm needle acupuncture or needle acupuncture. Participants and~     acupuncturists will be blinded to group allocation. The primary and secondary outcome~     measures are WOMAC and SF36 respectively. Qualitative interviews will be used to gather~     information on the patients' experiences and perceptions of the trial and the treatment~     provided.~      It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical~     signs and symptoms than needle acupuncture.~   "
28743|NCT02680899|"~     The study herein seeks to determine whether students undergoing InSciEd Out curriculum in~     mental health and addiction (called My Mind, My Body) experience changes in their mental~     health-related knowledge, attitudes, and help-seeking behavioral intentions. The research~     group hypothesizes that students undergoing InSciEd Out mental health and addiction~     curriculum will exhibit pre-post increases in mental health literacy, decreases in mental~     health stigmatization, and increases in mental health help-seeking behavioral intentions.~   "
28744|NCT02680886|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with other suture material used for skin closure. In order to show that, various~     safety and efficacy parameters have been selected. The outcome regarding these parameters~     will be evaluated by a quantitative summary of the available clinical data from the~     literature.~   "
28745|NCT02680873|"~     the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y~     bipartition reconstruction and the investigator are reporting the first clinical results of~     the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine~     modulation therapeutic option for obese type 2 diabetes mellituspatients.~   "
28746|NCT02680847|"~     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone~     hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.~   "
28747|NCT02680834|"~     The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area~     closure at 16 weeks with a dual action pneumatic compression device compared to multi-layer~     bandaging.~   "
32043|NCT02637687|"~     This is a multicenter, open label, Phase 1/2 study in pediatric patients with advanced solid~     or primary CNS tumors. LOXO‑101 will be administered orally (PO) twice daily (BID), with the~     dose adjusted by body surface area (BSA).~   "
28751|NCT02680782|"~     This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001~     administered as 200 mg twice daily compared with 400 mg once daily.~      This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg~     twice daily compared with 400 mg once daily on levels of circulating white blood cells~     (total and by cell type).~   "
28752|NCT02680769|"~     Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive~     pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar~     endothelial cells and low-grade inflammation, a typical state of COPD. In this sense,~     several randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since~     long-period oral supplementation of Mg leads to a clinical and spirometric improvement.~      Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of~     drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary~     Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or~     aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD~     relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction~     in pulmonary hyperinflation and increase in muscles involved in respiration, with a~     consequent clinical and instrumental improvement.~      These evidences suggest that a chronic supplementation with Mg could improve COPD in~     clinical and instrumental parameters, but, at the best of our knowledge, no study was~     available in this sense.~   "
28753|NCT02680756|"~     The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron~     (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and~     subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).~   "
28754|NCT02680743|"~     Objective:~      Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric~     sensorineural hearing loss (SNHL) and an important cause of neurodevelopmental delay.~     Infants with cCMV can be symptomatic, asymptomatic, or asymptomatic except for hearing loss.~     Symptomatic infants may be more readily identified and quickly referred for intervention~     because they may present with classic common clinical findings, but the majority of infants~     (85-90%) with cCMV are asymptomatic at birth and do not have the classic clinical,~     laboratory, or radiologic findings and therefore often have delayed identification and~     intervention. Often, these otherwise asymptomatic infants with cCMV may have early~     congenital hearing loss and therefore fail the newborn hearing screen but because they are~     not specifically identified as having cCMV there is a delay in seeking further audiology~     exam and treatment of the CMV infection.~      The overall objective of this proposed research is to investigate how testing newborns for~     congenital cytomegalovirus infection (cCMV) after a failed newborn hearing screens can~     improve early identification of cCMV infection and therefore reduce the delay in referral of~     the newborn to appropriate specialists for intervention.~      Eligibility Criteria:~      Eligible participants will include newborns in the NBN or NICU who are less than 14 days of~     life who fail the standard hearing screening.~      Interventions and Evaluations Saliva samples will be obtained from participating infants~     with a mouth swab according to an established protocol. The saliva will then be tested for~     CMV by qualitative polymerase chain reaction by ARUP Laboratories. Infants who test positive~     for CMV infection will then be referred for repeat audiology exam to confirm hearing loss~     and to Pediatric Infectious Diseases for evaluation and treatment if necessary. Parents or~     guardians of infants who test positive for cCMV will receive counseling on the importance of~     following up with these specialists. The primary outcomes measured will be cCMV prevalence~     data and time to referral and intervention.~      Follow up:~      Follow-up will be as clinically indicated and determined by the infant's primary care~     provider, pediatric infectious disease physician, and audiologist. It will not be determined~     by the study, referral to these services will be the study endpoint.~   "
28755|NCT02680730|"~     Purpose: A research project will be conducted at the ADD (Attention Deficit Disorder)~     Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening~     Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or~     behavioral regulation. The LPP is designed as a neural exercise to reduce auditory~     hypersensitivities, to improve auditory processing of speech, and to improve behavioral~     state regulation. These improvements should translate into increase feelings of safety and~     calmness, thereby promoting improvement in social behavior.~      Participants: 30 participants, males and females between ages 7-55 years, will be recruited~     for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of~     Toronto.~      Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will~     have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and~     1 month post intervention assessment. Group 2 will have an additional pre-intervention~     assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the~     stability of the measures prior to starting the intervention. Pre-, post-, and 1 month~     followup assessment will include parent and/or self-report questionnaires, and measures of~     the individual's auditory processing (SCAN), affect recognition (DARE Dynamic Affect~     Recognition Evaluation), heart rate, prosody, RSA respiratory sinus arrhythmia (derived~     from non-invasive ECG recording), and middle ear transfer function (MESAS - Middle Ear~     Sound Absorption System).~   "
28756|NCT02680717|"~     This is a study designed to evaluate the comparative effectiveness of topical medications~     for the treatment of circumscribed morphea.~   "
28757|NCT02680704|"~     The purpose of this study is to collect physiologic data from patients with severe brain~     injury who require mechanical ventilation in order to describe the impact of ventilation,~     specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).~   "
28758|NCT02680691|"~     The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke~   "
28759|NCT02680678|"~     Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of~     preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid~     infusions and their timing via perfusion index and plethysmographic variability index.~   "
28760|NCT02680665|"~     This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg~     under actual medical practice.~   "
28761|NCT02680652|"~     This is an observational, case--control study with a single blood draw among two cohorts,~     patients with CVID and healthy controls. Samples will be analyzed by cytometry (CyTOF) to~     simultaneously examine the major signaling pathways of all circulating innate and adaptive~     immune cell types as well as whole exome sequencing. The goal is to improve our general~     understanding of the human immune response to infections and the diagnosis of CVID.~   "
28777|NCT02680444|"~     Brief and cost-effective interventions teaching emotion regulation techniques can be~     feasibly applied to promote mental health in University students. The tools of mindfulness~     (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive~     re-evaluation of negative events) can mutually benefit one another to promote well-being.~     The current study explored the effects of a randomly-assigned Mindful-Reappraisal~     intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on~     university students' daily affect over five days. Time by condition interactions were~     analyzed with planned contrasts and multilevel growth modelling.~   "
28762|NCT02680639|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and~     mortality throughout the world, being the fourth leading cause of death in the world.~      This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL~     occurs when the airways become compressed which usually results when a pressure outside the~     airway exceeds the pressure inside the airway.~      Participants will undergo study eligibility procedures at visit 1. At visit 2 participants~     will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then~     the order will be randomized to three different treatment methods. Between each treatment~     there will be at least a 10 minute washout period in order for CO2 to stabilize and return~     to baseline.~   "
28763|NCT02680626|"~     Pain control after surgery is important for patient well-being and recovery. We are~     interested in determining whether we can improve the duration of action of a local~     anesthetic procedure (transversus abdominis plane block, or TAP block) by adding magnesium~     sulfate to local anesthetics given to patients after total abdominal hysterectomy with or~     without salpingo-oophorectomy.~   "
28764|NCT02680613|"~     The purpose of this study is to determine whether motivational text messages and/or travel~     vouchers are effective in increasing cervical cancer screening rates in urban and rural~     regions of Northern Tanzania.~   "
28765|NCT02680600|"~     Several population pharmacokinetic (PK) models for cefepime in critically ill patients have~     been described, all indicating that variability in renal clearance is the main determinant~     of observed variability in exposure. The main objective of this study was hence to determine~     which renal marker best predicts cefepime clearance.~   "
28766|NCT02680587|"~     Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation~     versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment~     planning, SBRT (1-5 fractions) will be administered.~   "
28767|NCT02680574|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance~     treatment of anemia in subjects with NDD-CKD~   "
28768|NCT02680561|"~     The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone~     propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and~     FS MDPI.~   "
28769|NCT02680548|"~     Injections of local anesthetics (freezing) and steroids are often performed around injured~     nerves in individuals with nerve injury-related pain. The current standard of medical care~     is to inject a combination of local anesthetics and steroids around injured nerves, but~     there is no proof that this is better than injecting only local anesthetic, or even just~     sterile salt water. There is evidence to believe that injection of local anesthetic (without~     the steroid) can calm the injured nerve, and provide pain relief from a few days up to a few~     months. Injection of sterile salt water also has the potential to provide pain relief by~     breaking scar tissue around the nerve, thereby relieving compression. The aim of this study~     is to compare pain relief and possible adverse effects from these three different treatments~     for foot and ankle nerve pain relief.~      All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto~     Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient~     will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up~     at 1 month after the last injection, and a phone follow-up 3 months after the last~     injection.~      This is a small-scale study, and information obtained from this study will help in planning~     and conduct of a larger study with more participants. The larger study will help determine~     the best possible option for injection in patients with nerve-related injury pain.~   "
28770|NCT02680535|"~     To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation~     of prostate tissue using nanoparticle-directed laser irradiation.~   "
28771|NCT02680522|"~     Introduction: The Parkinson is one of the most common degenerative diseases of the central~     nervous system , mainly characterized by resting tremor , rigidity, akinesia and postural~     instability , also featuring the autonomic modulation of heart rate , which can lead to~     reduced frequency variability heart . Some activities may modify the modulation , including~     rehabilitation using virtual reality. Method: The research is interventional type , quantity~     and prospective, where volunteers were chosen for inclusion and exclusion criteria and~     divided into two groups , Control and Parkinson's, where they underwent 24 sections with~     virtual reality physiotherapy three times a week . Analysis of the autonomic modulation of~     heart rate was performed before and after the rehabilitation program with the frequency~     meter Polar brand. Statistical analysis was performed in 5.2 Biostat program with Shapiro-~     Wilk test to verify the normality , followed by t test to compare the data.~   "
28772|NCT02680509|"~     The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular~     circulation in the affected fingers. This effect is analysed by performing cooling~     plethysmography and nailfold capillary microscopy bilaterally, following a unilateral,~     single-port thoracoscopic sympathicotomy.~   "
28773|NCT02680496|"~     The primary objective of the study is to investigate the energy consumption,~     cardiorespiratory load and perceived exertion, and how these parameters change, during~     walking with robot-assistance compared to walking on a treadmill and walking overground in~     stroke patients.~      A secondary objective is to investigate whether these changes or differences in energy~     consumption, cardiorespiratory load and perceived exertion during walking with and without~     robot-assistance in stroke patients are related to changes or differences spatiotemporal~     gait characteristics.~   "
28774|NCT02680483|"~     Prospective registry of all new comers with Atrial fibrillation~   "
28775|NCT02680470|"~     Using modern technology, investigators will observe participants taking their TB tablets~     three times per week using a mobile phone, iPod or computer with camera facilities in the~     participants home environment.~   "
28776|NCT02680457|"~     Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The~     long-acting insulin has showed to improve glycemic variability however the behavior of~     insulin glargine versus insulin degludec is unknown.~   "
28795|NCT02680210|"~     The study will be conducted over 18 months. The main objective of this study is to explore~     the relationships between autobiographical memory and specific cognitive measures, as well~     as emotional and behavioural measures in patients who have suffered a moderate to severe~     TBI. Secondary objectives are to assess the psychometric properties of a self-defining~     memories questionnaire and to characterize autobiographical memory in the TBI population.~   "
28778|NCT02680431|"~     The purpose of this study is to find blood plasma based biomarkers of disease progression in~     neurofibromatosis type 1 (NF1). NF1 is associated with the development of benign cutaneous~     tumors as well as a variety of malignancies. Analysis of plasma DNA and chemical composition~     may provide tools for diagnosis and follow-up of NF1. The hypothesis of the study is that~     NF1-associated tumor burden and malignant transformation of tumors can be detected in~     plasma. To test this hypothesis, Finnish patients with NF1 are recruited and blood sample is~     taken. Blood plasma is separated and analyzed chemically. DNA is then also extracted and~     quantified.~   "
28779|NCT02680418|"~     To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female~     subjects.~   "
28780|NCT02680405|"~     Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because~     certain proteins are increased in the skin of AD patients. The increased expression of these~     proteins play an important role in the development of AD and may increase the risk for~     persons with AD to get skin infections and allergies.~      There are very few non-invasive ways to diagnose and monitor the development and progression~     of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin~     samples collected by tapy stripping, that can be used for early detection and monitoring the~     response to treatment for a variety of skin diseases, including atopic dermatitis.~   "
28781|NCT02680392|"~     This randomized, double blind controlled trial is designed to investigate the potential~     benefits of radiofrequency in terms of analgesia and functional outcome, compared to the~     conventional continuous adductor canal block, for patients undergoing total knee~     arthroplasty for osteoarthritis.~   "
28782|NCT02680379|"~     The purpose of this study is to determine whether Lovastatin, Minocycline and the~     combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile~     X individuals.~   "
28783|NCT02680366|"~     This study evaluates the addition of collagen scaffold loaded with autologous bone marrow~     mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the~     treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC~     scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter~     balloon.~   "
28784|NCT02680353|"~     To determine the postoperative analgesic efficiency of bilateral superficial plexus block,~     patients are divided into two groups. Study group received bilateral superficial plexus~     block, where control had none. Visual analog scale, opioid consumption and presence of~     nausea-vomiting are recorded.~   "
28785|NCT02680340|"~     The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral~     stem revision rate at 10 years.~      The secondary purpose of this study is to provide 10 years of safety and effectiveness data~     of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance~   "
28786|NCT02680327|"~     This is a prospective epidemiological pilot study to evaluate the feasibility of recruiting~     and retaining patients in a large multicenter study that will audit Advanced Care Planning~     (ACP) practices and satisfaction with End Of Life (EOL) communication and decision-making in~     patients undergoing cardiac surgery using the current validated questionnaires and~     methodology.~   "
28787|NCT02680314|"~     The goal of this study is to determine whether inducing labor with just one dose of~     misoprostol, followed by treatment with oxytocin, will still be effective enough to increase~     the chances of having a successful vaginal delivery as compared to using more than one dose~     of misoprostol, followed by treatment with oxytocin.~   "
28788|NCT02680301|"~     The purpose of this study is to~        1. Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream~          formulation in patients with moderate to severe atopic dermatitis~        2. The relative patient/subject acceptance and adherence will also be compared between the~          two wet wrap types~   "
28789|NCT02680288|"~     This is a randomized, cross-over, single-blind, placebo-controlled, single-center,~     multiple-panel evaluation of the potential for oral lorcaserin to modify cocaine~     self-administration in a laboratory setting. To prevent unauthorized drug use, study~     medications will be administered as participants are confined during overnight stays at the~     Medical Center. Non-treatment-seeking, regular cocaine users will receive oral treatment~     with single doses of placebo, lorcaserin 10 mg (Panel 1), or lorcaserin 20 mg (Panel 2).~     Afterwards, the subjective and reinforcing effects of intravenous cocaine will be measured~     in a laboratory setting.~   "
28790|NCT02680275|"~     This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic~     Endometritis in women with reproductive disorders. Half of participants will receive Dead~     Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and~     antibiotics.~      Patients with reproductive disorders who visited Research Medical Center of Family Health~     Problems and Human Reproduction were recruited.~   "
28791|NCT02680262|"~     The trial will evaluate the effect on participation in organised screening programme of a~     human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand~     compared with the standard second reminder for regular screening.~   "
28792|NCT02680249|"~     Three way crossover study to assess the bioavailability of 656 under fed and fasted~     conditions.~   "
28793|NCT02680236|"~     Art therapy offers benefits and support for a range of psychological symptoms caused by~     cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity~     or end of life concerns. Persistent post treatment pain that adversely affects quality of~     life may be experienced by up to 50% of breast cancer patients. Factors such as depression,~     fear, anxiety or lack of sleep are shown to increase pain and suffering in people with~     cancer. A multitreatment approach treatment of cancer pain is therefore recommended. Art~     therapy offers an opportunity to communicate the experience of suffering in a non verbal~     mode and can be offered in addition to other treatment for pain. This pilot study proposes~     to explore the effect of art therapy on breast cancer patients' perception of pain, and its~     impact on daily functioning by offering four sessions of individual art therapy, spaced~     between one to three weeks apart.~   "
28794|NCT02680223|"~     This is a randomised controlled trial with the aim of testing the efficacy of coloured~     overlays and coloured lenses for the relief of visual stress and reading difficulties in~     children and young adults.~   "
28796|NCT02680197|"~     The study was designed to investigate the efficacy and safety of different doses CHF5259 a~     long acting muscarinic antagonist in patients with moderate to severe COPD.~   "
28798|NCT02680171|"~     Spatial neglect is a common attention disorder after right hemisphere stroke and is~     associated with decreased independence and quality of life. Despite its high prevalence in~     the stroke population, there is currently no standard of care for the treatment of neglect.~     Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into~     clinical care has been limited likely due to the lack of standardized procedures. The~     investigators have developed a computerized PA technique designed to better engage patients~     and assist clinicians. In this study the investigators aim to evaluate the feasibility and~     effectiveness of the computerized PA procedure in a typical health care setting, with the~     hypothesis that the PA procedure will improve patient's neglect symptoms.~   "
28799|NCT02680158|"~     The purpose of this study is to compare acute tear production produced by the Oculeve~     Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous~     tear deficiency.~   "
28800|NCT02680145|"~     This is a single center, prospective trial of pessary use prior to reconstructive pelvic~     floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in~     pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally,~     we will assess the impact that preoperative pessary use has on patient self-reported~     preparedness for surgery.~   "
28801|NCT02680132|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed~     Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of~     studies were separated by a washout period of 7 days.~   "
28802|NCT02680119|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule~     1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA.~     Dosing periods of studies were separated by a washout period of 5 days.~   "
28803|NCT02680106|"~     Evaluation of safety and performance of the SPINNER device and wound dressing in the~     treatment of donor-site wounds (DSW)~   "
28804|NCT02680093|"~     Pregnant Women beyond the date of birth. will be followed while coming to routine~     monitoring. physiological parameter of cervical length will be measured as the differential~     predictor to determine their due date. the cervical length will be measured as part of~     routine gynecologic examination to women who come for routine over due date follow up.~      additional medical data will be collected from the patient medical record.- demographic~     data, and all the routine prenatal medical care the women will receive up to the~     delivery.and delivery outcomes.~   "
28805|NCT02680080|"~     The list of medications that prolong the QT interval and can provoke torsade de pointes~     keeps expanding. This list includes not only antiarrhythmic drugs, but also medications with~     no cardiac indications. All these medications prolong the QT interval because they block a~     specific potassium channel on the myocardial cell membrane: the channel for the rapid~     component of the delayed rectifier potassium current or IKr. The risk for developing~     torsade de pointes for patients taking any of the medications with IKr blockade capabilities~     varies from >4% for antiarrhythmic drugs to <0.01% for non-cardiac medications. The risk~     depends on the strength of IKr blockade, but also on specific patient characteristics. The~     majority of patients who develop torsade de pointes from non-cardiac medications have~     identifiable risk factors. In this regard, patients with a congenital long QT syndrome are~     prone to develop torsade de pointes when treated with QT-prolonging medications. This is~     because, due to their genetically defective ion channels, patients with Long QT Syndrome~     (LQTS) have impaired ventricular repolarization and reduced repolarization reserve.~     Therefore, it is common medical practice to strongly advise patients with congenital LQTS to~     avoid all medications that have IKr channel blocker capabilities. it was reported that some~     flavonoids contained in pink-grapefruit juice block the IKr channel. These investigators~     also reported that drinking 1 liter of pink-grapefruit juice causes QT prolongation in~     healthy volunteers. The magnitude of the QT prolongation provoked by grapefruit juice was~     small However, drugs causing minor QT prolongation in healthy volunteers may provoke major~     QT prolongation in rare or sick individuals who are then at risk for developing torsade de~     pointes. Consequently, one could argue that, until proven otherwise, pink-grapefruit should~     be added to the list of drugs that are forbidden for patients with LQTS~   "
28806|NCT02680067|"~     In this phase 1 study, the lymphatic transport will be examined using Near InfraRed~     Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy~     individuals using a MultiSpectral Imaging System (MSImager).~   "
28807|NCT02680054|"~     The aims of the study are to see if additional insulin doses for the fat and protein in a~     meal, given at different times, improve blood glucose levels and are safe and acceptable to~     children with Type 1 diabetes using multiple daily insulin injections.~   "
28808|NCT02680041|"~     This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent~     prostate cancer after curative-intent primary therapy and negative or equivocal findings on~     standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine~     PET/CT. Site clinicians will manage study subjects per standard practices and will document~     any change in treatment based on review of 18F-fluciclovine PET/CT findings. All~     participants will be followed for up to 6 months, with clinical data collected for this~     study. An interdisciplinary panel will provide expert guidance to local readers on request.~     The final reporting of the PET/CT scan will be a single report by the local reader following~     any such discussion.~   "
28809|NCT02680028|"~     In England each year over 65,000 people fracture their hip. Most of these patients are~     elderly females with the fracture occurring after a simple trip or stumble. Approximately~     half of these fractures are classified from their relationship to the hip joint capsule as~     extracapsular. The majority of these fractures are treated surgically by internal fixation~     using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary~     nail).~      Recent randomised studies from Peterborough involving 1000 patients have indicated that~     there are modest benefits for treating this type of fracture with an intramedullary nail in~     comparison to a sliding hip screw. This study aims to progress from these earlier studies to~     determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any~     significant advantages or disadvantages to the standard length (220mm) intramedullary nail.~      Both implants to be used in this study are in routine use around the world and are being~     used within their licenced indication. The study is therefore using two different designs of~     implant within their recommended area of use, but in which there is uncertainty as to which~     is the best design.~   "
28810|NCT02680015|"~     This study examines how the PEERS (Laugeson & Frankel, 2010; Laugeson, 2016)~     social-behavioral intervention affects social relationships, and brain development and~     function in adolescents and young adults with autism spectrum disorder.~   "
28811|NCT02680002|"~     The main purpose of this study is to assess the usability of long-term stored H5N1 antigen~     and adjuvant. The study is designed to assist in stockpile management by assessing the~     safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine~     when administered with or without MF59® adjuvant.~   "
28812|NCT02679989|"~     An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk~     factors compared to an energy-matched continuous energy restricted (CER) diet. A randomised~     controlled parallel design trial will determine the impact of a short-term IER diet (2~     consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each~     week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy~     (disease-free) subjects with central obesity.~   "
28813|NCT02679976|"~     This is a single-visit prospective study to establish a real world Marketed Contact Lens~     'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between~     myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes),~     who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.~   "
28814|NCT02679963|"~     This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy~     and involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the~     SLCG).~      Five hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered~     prior to receiving the first line platinum-based chemotherapy and provide consent for~     retrieving archival tissue collection and providing translational blood samples and tumor~     biopsies.~        1. - Induction chemotherapy phase All patients will initially be treated with 6 cycles of~          platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should~          either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet~          (preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum~          doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted.~          Translational blood samples will be taken at the beginning of induction chemotherapy~          for all patients.~           Patients displaying progressive disease or stable disease after induction chemotherapy~          will be withdrawn and further optimally managed according to local practice. For them,~          an optional tumour biopsy will be performed at the end of the induction treatment.~        2. - Randomisation and maintenance phase Only patients who respond to platinum-based~          induction chemotherapy will be further randomised between olaparib and placebo. These~          patients must have been treated with 6 cycles of chemotherapy. However, patients who~          haven't received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3~          or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy~          cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1~          (NCI CTCAE v4.0).~      Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg [2 tablets of~     150 mg] taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will~     be assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and~     treatment will be administered until disease progression or unacceptable toxicity. Patients~     will then be optimally managed according to local practice. Follow-up will be for a minimum~     of 15 months from the time of randomization, and until last venue. All randomised patients~     will be asked to provide translational blood samples at randomization, on treatment and at~     the end of the treatment. Optional tumour biopsies will be performed at randomization, at~     the end of the treatment (or at disease progression if available).~   "
28815|NCT02679950|"~     The current proposal is a pilot study. The Investigators plan to use next generation genome~     sequencing (NGGS) to define the molecular and genetic profiles of 3 cases of germ cell tumor~     (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis and 3 cases~     of late relapse GCT's, which are characterized by yolk sac tumor (and AFP secreting)~     predominant disease.~      Investigators seek to demonstrate the feasibility of obtaining tissue biopsies (either~     archived or new biopsy) and utilization of NGGS in studying the molecular and genetic~     relationships between GCT's (with a component of yolk sac tumor) at the time of diagnosis~     and GCT's at the time of late relapse. This study will also provide preliminary information~     on genetic alterations, which may be a hypothesis for generating another study.~   "
28816|NCT02679937|"~     This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based,~     weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among~     military service members at-risk for obesity. The Fit4Duty program is an adaptation for the~     military of an existing civilian obesity prevention program, Project Health, which reduced~     obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition~     education control condition and is hypothesized to reduce excess weight gain beyond the~     control comparison program during the 2 year period following study participation.~   "
28817|NCT02679924|"~     Soft tissue augmentation with injectable hyaluronic acid (HA) is a well-established modality~     for the correction of facial volume loss, fat atrophy, fine lines, and wrinkles. HA is a~     glycosaminoglycan that is composed of repeating D-glucuronic acid and D-N-acetylglucosamine~     disaccharide units. Because HA is a natural and inert constituent of the dermis, it~     represents an ideal substance for soft tissue augmentation. Current FDA-approved HA fillers~     are typically utilized to either directly target specific cutaneous rhytids or to restore~     overall contours by placement into fat pads or along bony structures that have remodeled~     with age. Restylane® Silk is a transparent injectable HA gel that received FDA approval in~     June 2014 for use in the lips and peri-oral region. Its unique synthesis results in smaller~     and finer particles that demonstrate significant hygroscopic properties and give rise to the~     potential for unique applications. One such application concerns the concept of skin~     boosting whereby microaliquots of HA are placed into the skin to induce biophysical~     improvement in dermal characteristics (1). Using this technique, a recent split-body study~     by Streker et al. demonstrated significant aesthetic improvements in face, hands and~     décolletage (2). However, there have been no well-controlled studies with validated~     aesthetic outcomes utilizing Restylane® Silk in this fashion to date. Because of the unique~     combination of ultra-fine product and high water-attracting capability, the investigators~     hypothesize that microinjections of Restylane® Silk can be used in a grid-like injection~     pattern for rejuvenation of the aging cheek.~   "
28818|NCT02679911|"~     The main objective of this study is to compare subject's compliance and satisfaction for two~     modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl~     NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).~   "
28819|NCT02679898|"~     Obesity is directly related to arterial dysfunction and negatively associated to muscle~     strength. High-intensity resistance exercise is the favored modality to offset muscle~     weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection,~     and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole~     body vibration training (WBVT) has improved arterial function in overweight/obese women but~     appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding~     external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of~     this study was to examine whether loaded-WBVT would induce greater benefits than~     unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore,~     we examined whether these changes were similar to healthy lean young women.~   "
28820|NCT02679885|"~     It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can~     be found in low concentrations in semen. Because the drug has been associated with~     teratogenicity in laboratory animals, the question is raised as to whether the drug can be~     detected in female partners of sexually active males who are taking the drug to treat their~     multiple sclerosis.~   "
28821|NCT02679872|"~     Good non-technical skills (NTS) have been shown to prevent adverse events and errors.~     Improvements of NTS can be achieved by simulation based-team training.The NTS of the~     operating theatre team performing video-assisted thoracoscopic surgery (VATS) is speculated~     to differ fra open thoracic surgery, as is the case with technical skills; however, these~     have not been investigated. The aim of this study is to explore which NTS the members of the~     VATS team perceive to be most important to patient care and safety. Exploration will be done~     through a deductive, qualitative analysis of semi-structured group and individual interviews~     with VATS team members. A theoretical perspective of Hollnagels Safety-II will be taken~     using the taxonomy of Oxford Non-Technical Skills (NOTECHS) system with the aim of informing~     patient safety.~   "
28822|NCT02679859|"~     The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP)~     directed medical therapy prior to noncardiac surgery will be associated with improved~     cardiovascular outcomes, when compared to standard of care.~   "
28823|NCT02679846|"~     SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with~     Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of~     analysis.~      The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long~     term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This~     non-standardised medical practice, which aims at promoting the occurrence of seizures during~     the time limit of the monitoring period, exposes patients to significant risks which should~     be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.~      SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term~     VEEG monitoring on the frequency of seizure-related serious adverse events occurring during~     these monitorings and on the ability to obtain VEEG recording of seizures within appropriate~     time limits.~      10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs~     withdrawal will be used systematically, while the other ten EMUs will continue their current~     non-standardised practice of AEDs withdrawal, and will serve as a control group.~      The setting of the study will include a 6 months evaluation phase, prior to randomisation,~     during which the organisational characteristics, baseline EMUs' activity, current management~     of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center~     will be evaluated.~      The standardised study protocol of AEDs withdrawal has been defined on the basis of a~     systematic review of all relevant publications in the field.~   "
28824|NCT02679833|"~     A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with~     vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome~     variable is the difference in the change of methylmalonic acid after 3 months between the~     two study arms.~   "
28825|NCT02679820|"~     The immediate post cesarean section IUD insertion is a further step towards spreading more~     compliance to females in developing countries, with rapid increase in population size~   "
28826|NCT02679807|"~     This is a randomized, double-blind placebo controlled trial to evaluate the effect of a~     probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the~     experimental rhinovirus challenge model. A previous study documented that Bl-04 has~     significant effects on the innate immune response in the nose and this study will be powered~     to assess whether these effects translate into a demonstrable clinical benefit. Volunteers~     will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary~     analysis will be on the proportion of volunteers who develop a rhinovirus associated illness~     in the two treatment groups.~   "
28827|NCT02679794|"~     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and~     vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption~     of fruits and vegetables results in a limited availability of certain nutrients found in~     these foods such as carotenoids. Dietary carotenoids have health-promoting properties and~     are known to fight against disease. Although, maintaining adequate vitamin D status is~     critical for overall skeletal health and the prevention of osteoporosis, vitamin D~     insufficiency is also widespread in the United States. Eggs, egg yolk in particular, are~     known to be a good source of lipid and may improve the absorption of carotenoids and vitamin~     D found in co-consumed vegetables in young and older women. Therefore, the investigators are~     interested to see if consuming eggs with cooked vegetables will increase carotenoids and~     vitamin D absorption.~   "
28828|NCT02679781|"~     The general objective of the study is to compare the efficacy of administering midazolam~     orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:~     1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum~     working time.~   "
28829|NCT02679768|"~     Very little is known of depressed patients' mental state after being discharged from~     inpatient wards where they are provided with a sheltered environment with stable sleep wake~     cycle, regular meals, and regular physical and social activities. Our previous usability~     study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into~     patients' condition in the weeks after discharge. Results showed that patients over a four~     week period had significant day to day variations in self-rated mood and sleeping schedule~     and that the patients' sleep patterns were delayed with 45 minutes.~      In the actual study, SAFE II, we are investigating whether an intervention with a strong~     focus on the circadian timing of daytime activities, and sleep, coined Circadian~     Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse~     into depression after discharge.~   "
28830|NCT02679755|"~     A study of palbociclib in combination with letrozole as treatment of post-menopausal women~     with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole~     therapy is deemed appropriate.~   "
28831|NCT02679742|"~     A randomized, double-blind, placebo-controlled, parallel study to assess the effects of~     β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute~     process in older patients with sarcopenia in terms of muscle mass, muscle strength and~     physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a~     resistance training program or placebo with a resistance training program.~   "
28832|NCT02679729|"~     This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to~     better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy~     subjects~   "
28833|NCT02679716|"~     Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In~     computational fluid dynamics (CFD) studies [Kaufmann et al. 2012] 10% of ascending emboli~     caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients~     with RAO had a history of stroke [Wang et al 2006, Leisser et al 2010-2014], there is a~     discrepancy between CFD-studies and clinical observations. Mead et al. [7] postulated small~     emboli being washed into the cerebral arteries without causing clinical symptoms of stroke,~     whereas similar emboli being washed into the ophthalmic artery would cause RAO.~      There is a discrepancy between CFD-study results and clinical observations in RAO patients,~     indicating that there could be a high number of RAO-patients having had cerebral ischemies~     without symptoms of stroke (as postulated by Mead et al. 2002).~      Purpose of the present study is to evaluate hemodynamic pathological changes at the~     ophthalmic artery origin in patients with RAO detected with an already existing CFD-model~   "
28834|NCT02679703|"~     To evaluate the effect of the polarity of the electric current in healing.~   "
28835|NCT02679690|"~     Develop an evidence-based intervention aimed at patients with heart failure (HF) using~     color-coded cue cards to assist in the selection of foods appropriate to their sodium~     restricted diet. The milligram per serving sodium content of foods will be assigned~     color-coded green/yellow/red designation according to very low/moderate/high as identified~     by the United States Food and Drug Administration's definitions of sodium content.~      Assess patient knowledge of foods with sodium content appropriate for consumption on a low~     sodium diet before implementation of the intervention by calculating average milligrams of~     sodium per serving via choices made through simulated grocery store shopping.~      Evaluate application of patient knowledge about low-sodium food choices using a simulated~     grocery store shopping intervention by calculating average milligrams of sodium per serving~     via choices made using the color-coded card.~   "
28836|NCT02679677|"~     The typical clinical progression of COPD usually results in a decreased level of tolerable~     physical exertion for the patient. The avoidance of strenuous physical activity leads to a~     deteriorating level of physical fitness, which further decreases the patient's ability to~     undertake physical activities. Recent research has shown that whole body vibration has the~     potential to improve physical fitness of participants, including such measures as the 6~     minute walking distance. However, information concerning lung function is lacking.~      The goal of the study is to test whether the use of whole body vibration training has an~     effect on the lung function of patients with stable COPD, or if the previously observed~     effects can be attributed to either pharmaceutical therapy or physical therapy~     interventions.~   "
28837|NCT02679664|"~     The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of~     recruitment. In addition to feasibility data, the investigators will carefully collect~     clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in~     venous thromboembolism (VTE) patients.~      Eligible consenting patients who developed acute, symptomatic, and objectively confirmed~     proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated~     to 2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control~     group (usual care). The pilot trial consists of up to 4 study contacts over 6 months:~     screening, randomization, telephone follow-up (90 days), and final study visit (180 days).~   "
28838|NCT02679651|"~     We hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and~     pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type~     matched controls. Results will be measured objectively using ultrasound for tissue~     thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and~     disability index (MFPDI) for pain score. Furthermore, we predict that these results will~     help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine~     which patients would receive greatest benefit from fat grafting to the foot.~   "
28839|NCT02679638|"~     A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part~     aiming to identify and analyze demand factors, supply factors and perceptions affecting~     Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision~     points: participation role in the decision making process, hospital choice, treatment~     regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will~     participate in the qualitative part and 425 Israeli Breast Cancer patients will participate~     in the quantitative study.~   "
28840|NCT02679625|"~     Accurate assessment of fluid responsiveness (FRes) is central to guiding fluid management in~     septic and critically ill patients. As evidence accumulates that both inadequate and~     excessive fluid resuscitation are associated with increased morbidity and mortality, it is~     simultaneously becoming increasingly clear that current widely used methods to predict FRes~     are of questionable accuracy. The optimal technique to predict FRes would be a non-invasive~     point-of-care test with not only a high degree of accuracy, but also one which requires~     minimal training to perform correctly and may be easily performed repeatedly for serial~     evaluation of FRes during the ongoing management of the critically ill patient.~      To date, three major ultrasonographic modalities have emerged as viable candidates for the~     bedside assessment of FRes: 1) measurement of dynamic changes in inferior vena caval~     diameter (IVC-CI), 2) measurement of dynamic changes in peripheral arterial waveform derived~     variables (PA Doppler), and 3) echocardiographic measurement of dynamic changes in left~     ventricular outflow tract waveform derived variables (LVOT Doppler). In this study, the~     investigators will perform the first direct comparison of techniques representing all three~     of the above modalities in the prediction of FRes against a non-invasive bioreactance~     cardiac output monitor (the Cheetah NICOM™), which has been extensively validated against~     gold-standard invasive methods of cardiac output measurement. The investigators will compare~     the accuracy of these modalities in both spontaneously breathing and mechanically ventilated~     patients using passive leg raise testing (PLR) as a surrogate for volume challenge. In~     addition, the investigators will also elicit information from the treating physician(s) on~     their clinical assessment of FRes.~      The investigators will recruit adult patients in the ED and ICU with sepsis, who have~     received an initial bolus of 20-30 cc/kg of IV fluid, and can tolerate the PLR and US~     procedures. Prior to US and NICOM measurement, investigators will ask the attending~     physician managing the patient regarding their assessment of the their fluid status. Then,~     separate investigators will perform US and NICOM measurements independently to ensure~     blinding. NICOM data, which has been well validated in septic patients, will be shared with~     the attending physician. They will then be asked if this new data will change management.~   "
28852|NCT02679456|"~     This is a randomized, multicenter, evaluator blinded study to evaluate the safety,~     tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult~     patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent~     episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled~     and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose~     regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of~     treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of~     observation period visit) or at any time that a recurrence or clinical failure is suspected,~     up to the end of observation period.~   "
28841|NCT02679599|"~     Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not~     attending rehabilitation and there is a steep drop off in exercise following rehabilitation~     completion. Moreover, little is known about the amount of time that cardiac rehabilitation~     patients spend in sedentary behavior, which is associated with increased risk of~     cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot~     study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone~     application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity~     physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related~     MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited,~     enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1)~     B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone.~     Participants will complete 7 days of objective activity monitoring to measure daily minutes~     spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline,~     mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up~     (16 weeks). At these same time points, participants will complete questionnaires assessing~     sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and~     affect. At baseline and end of cardiac rehabilitation participants will undergo a blood draw~     to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive~     functioning. Feasibility and acceptability of the B-MOBILE-CARDIAC application will be~     assessed at the 4-week follow-up.~   "
28842|NCT02679586|"~     This is a single-arm, single-institution pilot study that will collect preliminary data to~     be used in the design of a subsequent study to assess whether changes in fDM (Functional~     Diffusion Maps) derived from primary breast cancer diffusion weighted MRI images can serve~     as an early predictor of response to treatment, and whether the magnitude of the change~     correlates with the effectiveness of treatment.~   "
28843|NCT02679573|"~     The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to~     moxifloxacin in the treatment of adult patients with community-acquired pneumonia.~   "
28844|NCT02679560|"~     This is an investigator-initiated, single-center, randomized, patient blinded, controlled~     trial. The purpose of this study is to compare the effect of a fascia iliaca compartment~     block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or~     hip fractures admitted to the University of California Davis Medical Center (UCDMC). The~     primary endpoint will be the total opioid requirements during the 72 hour randomization~     period with secondary endpoints including total daily opioid requirements for days 1-3,~     duration of effect and objective pain scores using the numeric rating scale (NRS) during~     their hospital stay.~   "
28845|NCT02679547|"~     Appendectomy is the most common emergent operative procedure performed worldwide. In this~     study investigators will investigate if there is a relationship between breast feeding and~     appendicitis in adults.~   "
28846|NCT02679534|"~     Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the~     multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that~     cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high~     as 74% despite the use of analgesics. The highest pain intensity is experienced in the first~     24 hours post surgery when patients are still in the ICU, and represents a strong predictor~     for the presence and severity of persistent postoperative pain. To maximize pain relief,~     massage has been suggested in the recent clinical practice guidelines of the Society of~     Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its~     opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed~     promising pain relief effects of massage when administered to cardiac surgery patients in~     acute care units, however, its effects on pain relief while patients are still in the ICU~     and when pain severity is highest remain unknown.~      This study aims to compare the effect of three 20-minute hand massage administrations within~     24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain~     interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory~     rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding~     (i.e., simple touch) and standard care. Other objectives are to describe the location and~     quality of pain of cardiac surgery ICU patients.~      Hypothesis:~      Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity,~     unpleasantness and interference, muscle tension, anxiety and vital signs compared to~     patients receiving hand holding and to those in the standard care group.~   "
28847|NCT02679521|"~     Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an~     efficient treatment option for heel pain associated with chronic proximal plantar fasciitis~     when administered in three sessions. The present study tested the hypothesis that heel pain~     associated with chronic proximal plantar fasciitis can also be treated successfully with~     rESWT when only two treatment sessions are performed.~   "
28848|NCT02679508|"~     The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and~     the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in~     patients receiving maintenance treatment after healed erosive esophagitis (EE), and the~     curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.~   "
28849|NCT02679495|"~     The purpose of this study is to determine whether positive life style interventions (such as~     diet modification and smoking cessation) are effective in the prevention of gastric~     pre-cancer and cancer occurrences and reccurence of gastric cancer after edoscopica~     resection.~   "
28850|NCT02679482|"~     The purpose of this study is to follow and describe the outcomes of patients after selective~     and pascal laser trabeculoplasty treatment for chronic open-angle glaucoma.~   "
28851|NCT02679469|"~     The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg~     in healthy Japanese male subjects will be evaluated.~   "
28877|NCT02679131|"~     A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in~     patients with relapsed/refractory solid tumors or hematological malignancies in patients~     with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D)~     based on their level of renal function (normal, mild, moderate, or severe renal impairment)~     and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate~     or severe renal impairment.~   "
28853|NCT02679443|"~     Folic acid (FA; folate) in the dose of 350-1,000 μg daily should be supplemented, daily,~     starting 7 days before the first dose of pemetrexed based chemotherapy and should be~     continued while the patient is on therapy and for 21 days after cessation of therapy.~     Vitamin B12 injections (1,000 μg i.m.) should also be started 1 week before the first dose~     of chemotherapy. However, the evidence for delaying chemotherapy by seven days for the~     purpose of giving vitamin B12 and FA supplementation is not robust. Observational and~     prospective single arm studies have not shown any increased toxicity if pemetrexed was~     started earlier than the recommended duration of supplementation. In a resource constrained~     setting, this will lead to one additional visit and 1-week chemotherapy delay which may be~     inconvenient for patients.~      Hence an open label, randomized control trial is being undertaken to evaluate if there are~     any differences in pemetrexed related hematological toxicity amongst patients who receive~     delayed initiation of chemotherapy (following 5 - 7 days of vitamin B12 and FA~     supplementation; Delayed Arm) as compared to those in whom vitamin B12 and FA~     supplementation is starting simultaneously (within 24 hours) of initiation of chemotherapy~     (Immediate Arm).~   "
28854|NCT02679430|"~     Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous~     to uterine fibroid embolization for women, is safe and effective.~   "
28855|NCT02679417|"~     The type of physical activity such as, aerobic or resistant exercise required to reduce~     liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear.~     The purpose of this study is to determine whether aerobic exercise should provide~     improvement of hepatic fat content and inflammation as well as metabolic profiles and~     anthropometric parameters better than resistant exercise.~   "
28856|NCT02679404|"~     Multi-center, International, Prospective, Non comparative, Non randomized, Open label.~      5,000 patients to be enrolled approximately worldwide.~      The objective of this registry is to collect safety and clinical performance post market~     data related to the procedure and follow-up of the Sorin Group aortic valve devices in~     accordance with the Instructions for Use (IFU).~      This observational global registry is intended to collect data without requiring any~     deviation from the standard of care and IFU in each participating center. The participating~     centers shall include those patients that have provided their informed consent to~     participate in this registry in accordance with the local applicable regulations.~   "
28857|NCT02679391|"~     The primary aim of this study is to compare early surgical complications after~     abdominoplasty performed by plastic and general surgeons. Secondary aims were to assess~     whether specific guidelines might have impact on the rate of complications. The hypothesis~     is that general surgeons have more complications.~   "
28858|NCT02679378|"~     Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study~     comparing ClearSight system to histopathological to determine negative-margins in breast~     conserving surgery.~   "
28859|NCT02679365|"~     In this trial we compare the effect of 2 closure techniques of the rectus sheath during~     cesarean sections on postoperative pain. One closure technique is double lock technique and~     the other is the conventional continuous non-locking technique.~   "
28860|NCT02679352|"~     Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint~     diseases to relieve pain and restore shoulder function.~      Shoulder implants commonly used are characterised by a humeral stem and complications~     related to the stem are not infrequent. These include: bone stock loss, intraoperative and~     postoperative break around the implant, malpositioning of the humeral component and~     difficult eradication of infections inside the bone around the implant.~      With the aim of reducing stem-related complications, a novel prosthesis characterised by a~     stem-less design has been developed.~      The objective of this study is therefore to explore how well people recover after shoulder~     replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5~     years in three different countries in Europe using patient completed questionnaires and~     clinical and radiographic assessments.~   "
28861|NCT02679339|"~     Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo~     controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will~     be evaluated in subjects with acute-onset herpes zoster pain.~   "
28862|NCT02679326|"~     The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the~     treatment of Plantar fasciitis (PF).~   "
28863|NCT02679313|"~     This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges,~     AC/A and accommodative findings) measured when lenses and/or prisms are introduced using~     three different instruments namely: (i) a standard manual phoropter, (ii) an electronic~     phoropter and (iii) a wearable adaptive refractor (VisionFit).~   "
28864|NCT02679300|"~     Immersion in a virtual reality environment has been shown to reduce pain during a variety of~     painful medical procedures, such as wound care for burn patients and dental care. Often,~     serious games are used to distract patients from this painful procedures. Recently, serious~     games have also been developed for patients with low back pain. Because patients with low~     back pain frequently experience pain during exercises, the investigators hypothesize that~     exercising with serious games can reduce the pain intensity and the time spent thinking of~     pain during exercises. To test this hypothesis, the investigators will conduct a randomized~     controlled trial where two groups will be compared: the experimental group will perform one~     session of exercises with serious games, while the control group will perform one session of~     the same exercises without the serious games.~   "
28865|NCT02679287|"~     The purpose of this study is to use an investigational type of technology called Closed-Loop~     Control (CLC) Medical Platform System to help control blood sugar in people with type 1~     diabetes mellitus in a home setting.~   "
28878|NCT02679118|"~     This study will determine the ability of the device to draw a small amount of gas from an~     insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content~     from the bowel is present.~   "
28879|NCT02679105|"~     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy~     in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be~     treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and~     10 000 SQ-U, or placebo.~   "
42466|NCT02501135|"~     The purpose of this study is to retrospectively compare perioperative pain relief and safety~     in pediatric patients who have received a femoral nerve block with varying concentrations of~     local anesthetic.~   "
28866|NCT02679274|"~     Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home~     residents. Testosterone treatment is among the potentially beneficial treatments in addition~     to resistance exercise for improving muscle strength and mass in frail adults. The~     investigators have demonstrated that cycled administration of testosterone improves muscle~     mass and strength in healthy adults. It is proposed that cycled testosterone administration~     may be an effective adjuvant therapy for frail older men and women during rehabilitation~     programs. The hypothesis is that testosterone treatment in addition to standard-of-care~     (SOC) rehabilitation will result in improved muscle mass and physical function when compared~     to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled~     study, the investigators will test the effects of cycled testosterone administration (2 week~     on treatment, 2 weeks off treatment) on body composition and physical function in male and~     female nursing home residents undergoing rehabilitative care. Primary outcomes will be~     assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip~     dynamometers, short physical performance battery (SPPB), and quality of life (QOL)~     questionnaires. Data from this pilot project will become the foundation for the development~     of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of~     testosterone treatment on physical function and independence in frail older adults.~   "
28867|NCT02679261|"~     Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of~     the population. The aortic dilation and aortic valve degeneration are common complications~     in patients with BAV. Statins have shown a reduction in the expression of metalloproteinases~     of the extracellular matrix observed in aortic aneurisms. Several retrospective studies have~     suggested the benefit of the statins to reduce aortic dilation in patients with BAV.~     Moreover, although statins did not show to be useful in the progression of aortic stenosis,~     different studies have suggested a higher profit when the valve affection is not severe. The~     objective of this study is to determine whether atorvastatin is effective at reducing the~     progression of aortic dilation in patients with BAV.~   "
28868|NCT02679248|"~     This study will investigate the effect of a nitric oxide supplementation product, Neo40~     Daily®, on blood pressure in pre-hypertensive and mildly hypertensive adults. Subjects will~     take 2 lozenges per day 12 hours apart for 8 weeks. Half of the subjects will receive Neo40~     Daily® and the other half of the subjects will receive placebo.~   "
28869|NCT02679235|"~     BEAT7-001 is a randomised, open label, two parallel group study (supplementation versus~     control). Using a multi-modal brain imaging portfolio, this study will assess whether brain~     energy metabolism (glucose and ketones), structure or functional connectivity change in~     older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day~     of triheptanoin.~   "
28870|NCT02679222|"~     The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils~     (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each~     oil are evaluated individually or in combination over a 8h-period during which repeated~     blood sampling is performed.~   "
28871|NCT02679209|"~     A clinical and radiographic evaluation of 4 regenerative techniques, bioresorbable membrane,~     bone allograft, combined bone allograft and membrane and open flap debridement for~     management of periodontal intrabony defects.~   "
28872|NCT02679196|"~     Multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and~     pharmacodynamics effects of KA2237 (PI3 Kinase p110β/δ Inhibitor) in patients with B Cell~     Lymphoma and determine the maximum tolerated dose (MTD) in Part I of the study. In Part II,~     patients with B cell lymphoma will be treated with KA2237 at the MTD to evaluate safety and~     efficacy in the patient population.~   "
28873|NCT02679183|"~     Honey is a natural product that contains multiple nutrients; it is composed of fructose,~     glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also~     contains more than 180 substances including amino acids, vitamins, minerals and enzymes.~     Investigators hypothesized that supplementation of enteral feeds with honey would produce a~     bifidogenic effect and stimulate the immune response in preterm infants. Investigators~     randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2~     weeks and measured their effect on stool colonization, systemic immune parameters and~     anthropometric measurements.~   "
28874|NCT02679170|"~     Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell~     Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management~     under clinical practice (IDEALK)~   "
28875|NCT02679157|"~     Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care~     Unit Stay - a multinational, observational study~      Objectives:~        1. To investigate associations between potential risk factors (premorbid factors, in-ICU~          treatments/diagnoses and patient status at ICU discharge) and three-month physical and~          psychological outcome in ICU survivors.~        2. Based on the associations between identified risk factors and adverse outcomes, create~          and validate instruments, to be used at ICU discharge, predicting new-onset physical or~          psychological problems three months after ICU discharge.~      Study design:~      Prospective, observational multi centre (10 centres) cohort studies~      Outcomes:~      Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress~     Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS)~     subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index~     ≥10 points compared with 2 weeks prior to hospital admission.~      Study duration:~      Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary~     endpoints 3 months after ICU discharge.~      Number of subjects:~      The aim is to screen all eligible patients and include 600-1000 ICU survivors during the~     recruitment period. The final number of included patients depends on case-mix in the units~     and potential exclusions.~      Population:~      Adult patients (18 years or older) discharged from ICU.~   "
28876|NCT02679144|"~     Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,~     study for patients with neuroblastoma in remission. In this study subjects will receive 730~     Days of oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID on each day~     of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that~     are in remission as a strategy to prevent recurrence.~   "
43134|NCT02492399|"~     The purpose of this study is to determine whether the application of the extended myoectomy~     in patients with obstruction of the left ventricular output more efficient than standard~     myoectomy by Morrow.~   "
28880|NCT02679092|"~     Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate~     pre-operative preparation of the uterine cervix is an important part of preventing~     complications of the procedure. Traditionally, the uterine cervix is prepared for the~     procedure using water-attracting dilators, which are placed via a speculum exam and cause~     discomfort for many women. The objective of this study is to investigate the comparative~     effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for~     D&E.~   "
28881|NCT02679079|"~     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of~     NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will~     enroll approximately 90 male and female pediatric subjects clinically diagnosed with~     Tourette Syndrome.~   "
28882|NCT02679066|"~     There is no consensus regarding the need to immobilize the elbow in immediate immobilization~     of closed distal radius fractures post-reduction. Decreased functionality of the upper~     extremity is a notable morbidity associated with below-elbow splinting of distal radius~     fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting~     versus short-arm casting as methods of immediate post-reduction immobilization. The study~     will randomize patients with close distal radius fractures to short forearm casting versus~     sugar tong splinting with close follow up including radiographic and clinical evaluation.~      This will provide guidance regarding the need for short forearm cast immobilization versus~     sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as~     well as functional effects of sugar tong splinting versus short forearm casting.~   "
28883|NCT02679053|"~     The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as~     adon treatment for moderately to severely depressed inpatients. Endpoints are symptom~     severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal~     axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).~      Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post~     (+6weeks) in already existing blood samples.~   "
28884|NCT02679040|"~     At present, it is widely admitted not proposing immediate mammary reconstruction when an~     adjuvant radiotherapy is indicated because of the significant change of the cosmetic result~     (profit) and it whatever is the technique of reconstruction adopted. This is true all the~     more as it is about a reconstruction by prosthesis because of the prothetic died risk of~     hull(shell).~      Teams proposed immediate mammary reconstructions to expanding (carrier) patients of~     carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought~     back(reported) by increase of the risk of local or remote relapse.~      Two studies estimated afterward the feasibility of the mastectomy with immediate mammary~     reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of~     morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar~     to the patients benefiting from the classic therapeutic plan.~      During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is~     possible and that by prescribing the chemotherapy and the radiotherapy before immediate~     mammary reconstruction, the morbidity is acceptable.~      It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative~     chemotherapy as regards the global survival.~      On the other hand, the rate of histological answer, according to subgroups, is very~     different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-,~     Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.~      The purpose of the investigators study is to estimate the rate of histological response~     during the inversion of therapeutic sequence to make sure of the oncologic safety(security),~     in particular by molecular subgroups, considering the heterogeneousness of the~     results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier~     Classifications is the references and will be used here, but the investigators can also use~     Symmans classification in addition.~      The rate of local and metastatic second offenses(recurrences) will also be estimated.~   "
28885|NCT02679027|"~     Objectives: The aim of study is to determine the possible usage of tongue movements out of~     the mouth in the prediction of difficult intubation.~      Method: Two hundred twenty three patients undergoing abdominal surgery with general~     anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was~     evaluated using the intubation difficulty scale (IDS) score. All intubations were performed~     by anesthesiologist to eliminate the differences among the anesthesiologists' experiences.~     IDS score were evaluated by anesthesiologists who had no idea about the measurements of the~     tongue movements and performed laryngeal intubation in all patients.~      To define the tongue movements, horizontal lines were used. Horizontal line were passing~     through the mid points of mandible and upper lip height. Patients were asked to protrude~     tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in~     anatomical neutral position which was sitting down on a chair.~   "
28886|NCT02679014|"~     A randomized, double-blind, placebo-controlled, two treatment, parallel group study to~     investigate the effects of RG7625, a cathepsin S inhibitor, on the immune response to a~     gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed~     celiac disease will be randomized to receive either 100 milligrams (mg) RG7625 or placebo~     twice daily with food for 28 days (Days 1 to 28).~   "
28887|NCT02679001|"~     This six months non-interventional, observational, post-marketing, multi-center and local~     study will evaluate the differences in the use of corticosteroids between RA participants~     receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a~     TNF-inhibitor as their first biological treatment.~   "
28888|NCT02678988|"~     The study consists of an eligibility screening period, two study periods involving single~     doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover~     design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy~     participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled~     syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The~     total duration of the study is up to 16 weeks from screening to follow-up. After screening,~     eligible participants will be randomly assigned to one of the two possible treatment~     sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by~     AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper~     arm). All participant groups will receive a total of two TCZ administrations each.~   "
28889|NCT02678975|"~     Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since~     the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical~     data to support disulfiram as an anticancer agent. The potency of disulfiram as an~     anticancer agent seems strengthened by copper.~      The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment~     in glioblastoma patients with recurrence receiving alkylating chemotherapy.~   "
28890|NCT02678962|"~     The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of~     Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313~     MF30T.~   "
28891|NCT02678949|"~     The multiple breath washout (MBW) is one of pulmonary function test that displays flow and~     gas concentration plotted against time, and shows an exponential decay in end-tidal gas~     concentration (washout curve). A number of of indices to describe the washout curve have~     been proposed, the most commonly reported is the Lung Clearance Index (LCI). This is a~     simple measure of ventilation heterogeneity derived from MBW, that can be used after~     challenge with a short action bronchodilator and in response to inhaled steroids, both in~     the conductive airways as acinar. Patients with moderate and severe asthma are characterized~     by an abnormality in both, conductive and the acinar airway. Therefore the following~     research question could be: what are the abnormalities in the heterogeneity of ventilation~     in children with mild and moderate asthma, with respect to the healthy population measured~     by MBW, and whether these alterations persist after challenge with inhaled steroids and B2~     agonists short-acting.~   "
28892|NCT02678936|"~     Anal fistula is a very common disease with a high impact on life quality. The only commonly~     accepted treatment option is surgery. A wide range of operations and techniques have been~     developed all suffering from a relatively high recurrence rate.~      The investigators propose the combination of the mucosal advancement flap with application~     of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the~     hypothesis that by applying PRP the healing rate of complicated anal fistulas can be~     improved in comparison to a control group where the operation is performed without addition~     of PRP.~   "
28893|NCT02678923|"~     This study will be a proof of concept, placebo-controlled, double-blind, randomized trial in~     participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy,~     pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and~     pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5~     infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.~   "
28894|NCT02678910|"~     The purpose of this research is to obtain ovarian tissue from female participants who will~     receive therapy which is expected to result in a loss or impairment of ovarian function~     and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of~     initiating a pregnancy in the future.~      Removal of the ovary for cryopreservation is an investigational procedure. 80% of the tissue~     will be used for the participant's future use and 20% will be sent to the Oncofertility~     Consortium at Northwestern University for research purposes. There have been 26 pregnancies~     as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and~     hormonal function has been restored in individuals for up to 7 years~      By doing this study, the investigators hope to learn of how to successfully freeze and thaw~     ovarian tissue in a manner that permits subsequent use by patients at some point in the~     future. Participation may also advance our knowledge of how to successfully mature follicles~     and oocytes (eggs) that are contained in these tissues which may help others in the future.~   "
28895|NCT02678897|"~     The study is two-parted. First part's aim is to map need of pain medication among patients~     undergoing medical abortion in early pregnancy (under 9 pregnancy weeks). In second part~     investigators compare different administration routes of opiates in patients in medical~     abortion with pregnancy weeks 12-20. In both parts plan is to compare teenaged to adult~     women and in addition to try to map predicting factors of severe pain.~   "
28896|NCT02678884|"~     The purpose of this study is to see how useful the information provided from Positron~     Emission Tomography (PET) scans can be in the actual planning and delivery of radiation~     treatment to patients who have head and neck cancers. Patients participating in this study,~     will have (in addition to their routine tests) a PET scan before and during their radiation~     treatment. Following the intervention, patients will be followed as per standard practice.~   "
28897|NCT02678871|"~     Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter~     aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for~     the prevention of ischemic stroke is very challenging in this population of complex and~     frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHAMN~     device proved promising safety and efficacy results in randomized comparisons with OAC~     (current standard of care), the aim of the current study is to assess the feasibility and~     the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with~     the WATCHMAN device at the same session.~   "
28898|NCT02678858|"~     The ISST study investigates whether integrated social cognitive remediation and social~     behavioral skills therapy is more efficacious in improving functional outcome and treatment~     adherence than an active control treatment comprising drill-and-practice oriented~     neurocognitive remediation.~   "
28899|NCT02678845|"~     The purpose of this study is to determine whether treatment of patients with depression~     according to the Collabri Model is more effective in reducing symptoms compared to treatment~     as usual (TAU)~   "
28900|NCT02678832|"~     The study, investigates the current physical activity promotion practices among physicians~     and nurses, as well as social norms toward physical activity during treatment among cancer~     patients and among physicians and nurses who treat or counsel cancer patients.~      For this purpose, four large surveys with health care professionals (specialized~     practitioners, N=300; general practitioners, N=300; oncology nurses, N=300) and cancer~     patients (N=1200, 400 patients each with breast, prostate or colorectal cancer) with a~     cross-sectional research design are conducted.~      Additionally, a follow-up-study with a sub-sample of cancer patients (N=180) will be~     conducted.~   "
28901|NCT02678819|"~     The purpose of this study is to determine whether a wearable digital cognitive aid has an~     effect in the management of simulated crises in anesthesia or intensive care.~   "
28918|NCT02678598|"~     The objective of this study is to evaluate the efficacy of intravenous micafungin for the~     empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal~     therapy or targeted antifungal therapy patients with invasive fungal infections caused by~     Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in~     adult patients in China.~   "
28919|NCT02678585|"~     The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia~   "
29141|NCT02675699|"~     This study will test whether parent engagement (recruitment, attendance) in a Childhood~     obesity prevention programme (HENRY) can be improved in local authorities randomised to~     receive an Optimisation intervention (in addition to standard HENRY) compared to those~     continuing to deliver the programme as standard.~   "
28902|NCT02678806|"~     Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but~     the five-year relative survival rate is relatively quite low1-3. For hepatocellular~     carcinoma treatment, current options are surgical resection, embolization chemotherapy,~     radiation therapy, a variety of ablation therapy, biological and gene therapy, etc. Among~     them, the use of radiation therapy is getting more and more attention, and it is changing~     from the past palliative treatment to current curable treatment. From an oncologic point of~     view, a narrow margin <1 cm and microvascular invasion is not safe and is often associated~     with higher rates of recurrence and shorter patient survival.On the other hand, it is also~     believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are~     distant from the resection margin. To address this issue, the investigators are going to~     conduct a series of retrospective and prospective studies to investigate the effect of~     adjuvant Radiotherapy for centrally located hepatocellular carcinoma after narrow margin (<1~     cm) hepatectomy on tumor recurrence.~   "
28903|NCT02678793|"~     Subjects who have completed study 4975-MN-202 will be eligible to receive open-label~     treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion~     criteria.~   "
28904|NCT02678780|"~     This is a prospective, international, multi-center, open label, stratified, exploratory~     phase II study evaluating the efficacy and safety of lenvatinib in patients with~     advanced/metastatic, neuroendocrine tumors of the pancreas after progression to a previous~     targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin~     analogues (cohort B).~   "
28905|NCT02678767|"~     This project will investigate the ability of a novel MRI contrast agent to identify and~     quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of~     HIV-infected individuals.~   "
28906|NCT02678754|"~     This data collection Registry is a multi-center, observational outcomes Database designed to~     collect data on the demographics, presentation, diagnosis, treatment, resource use, quality~     of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for~     treatment of solid tumor cancer.~   "
28907|NCT02678741|"~     Assess the safety and tumor response of utilizing an autologous tumor lysate,~     particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care~     (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with stable or slowly~     progressing disease.~   "
28908|NCT02678728|"~     Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress~     in diverse clinical settings. The investigators aimed to investigate the lung protective~     effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic~     circulatory arrest, which is associated with systemic inflammatory response, and oxidative~     stress.~   "
28909|NCT02678715|"~     This observer-blind crossover intervention study aims to determine the most effective type~     of device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three~     types of devices: standard, prefabricated and manufactured in the dental laboratory.~      Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge~     will use the three devices at a random sequence during the twelve treatment sessions, so~     each device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.~   "
28910|NCT02678702|"~     Participants (N=48) are patients with major depression in an outpatient clinic for affective~     disorders.~      Participants are assessed with clinical interview, polysomnographic evaluation and screening~     with Insomnia Severity Index (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HAM-D17,~     MINI and Sleep Diary pre and post treatment.~      Participants are randomly assigned to either treatment as usual or CBT-I. The latter~     receives individual as well as group therapy with CBT-I during 6 sessions.~      Post-treatment: The investigators will compare changes in polysomnographic measures, sleep~     diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test,~     Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.~   "
28911|NCT02678689|"~     This Phase 2 open-label study will evaluate the safety, tolerability, and efficacy of BMN~     190 intracerebroventricular (ICV) administration at 300mg every other week (qow) for a~     period of 96 weeks, in patients with CLN2. The study is designed to assess disease~     progression in siblings of children enrolled in the 190-201 study.~   "
28912|NCT02678676|"~     The purpose of this study was to investigate the mortality and macrovascular morbidity as~     well as the incidence of malignancies over time, in high-risk diabetic participants who~     previously received long-term treatment with either pioglitazone or placebo in combination~     with their usual medication for glycaemic management.~   "
28913|NCT02678663|"~     Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may~     arise as a consequence of incomplete polypectomy. However, the ideal method to remove small~     colorectal polyps remains uncertain. The investigators designed a randomized controlled~     trial to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR~     for the resection of small (6-10mm) colorectal polyps.~   "
28914|NCT02678650|"~     It has been reported that volatile anesthetics preconditioning mediates protection of organ~     via microRNA. We want to study on the effects of isoflurane preconditioning on expression of~     microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.~   "
28915|NCT02678637|"~     Mitochondrial disorders are a group of inherited disorders causing malfunctional~     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore~     give symptoms from every tissue, especially those with high energy needs as the brain, heart~     and muscles. The disorders are highly disabling.~      The aim of the study is to investigate the relation between muscle strength and contractile~     cross sectional area (CCSA) in the leg of patients affected by mitochondrial diseases. The~     hypothesis is that there can be a disrupted relationship between strength and CCSA.~   "
28916|NCT02678624|"~     The purpose of this study is to determine whether treatment of patients with anxiety~     according to the Collabri Model is more effective in reducing symptoms compared to treatment~     as usual (TAU)~   "
28917|NCT02678611|"~     This study will investigate the safety, tolerability and potential health benefits of the~     dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third~     of subjects will receive the low dose Basis, one third will receive the higher dose Basis~     and one third will receive placebo.~   "
28920|NCT02678572|"~     This study will evaluate two groups of patients who have melanoma that has spread from the~     eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to~     the liver, while the other group (50%) will get one of 4 standard best alternative care~     treatments. Patients in each group will get repeating cycles of treatment until the cancer~     in the liver advances and will be followed until death. This study will evaluate the effect~     of the treatments on how long patients live and how long it takes for the cancer to advance~     or respond to the treatment.~   "
28921|NCT02678559|"~     The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke~     volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations~     will be measured on preload dependency or preload independency status. The principal purpose~     is to determine if variations of stroke volume during standardized ARM can predict the~     preload dependency status.~   "
28922|NCT02678546|"~     Several questionnaires have been developed for clinical research in Traditional Chinese~     Medicine. The objective of this study is to evaluate the consistency and relevance of two~     questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body~     Constitutions Questionnaire (BCQ).~   "
28923|NCT02678533|"~     The purpose of this study is to assess the feasibility of Plerixafor used in combination~     with G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize~     and collect a sufficient number of peripheral blood CD34+ cells for peripheral blood~     apheresis, for further gene therapy study.~   "
28924|NCT02678520|"~     Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D~     Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in~     Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy~   "
28925|NCT02678507|"~     The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to~     identify opioid abuse and misuse behaviors among participants who have chronic pain which~     requires long-term opioid use.~   "
28926|NCT02678494|"~     A study examining the effectiveness of neurofeedback therapy for the treatment of Central~     Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly~     device which can be operated by patients at home.~   "
28927|NCT02678481|"~     To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy~     and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at~     least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric~     MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will~     be randomized (1:1) into the two study arms.~   "
28928|NCT02678468|"~     To evaluate the effect of early vision screening with automated photorefraction device in~     high risk children~   "
28929|NCT02678455|"~     The purpose of this study is to evaluate the safety and immunogenicity of the recombinant~     live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in~     healthy adults, adolescents, and children in Dhaka, Bangladesh.~   "
28930|NCT02678442|"~     This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue~     from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA~     and cellular material is superior for Flexible Needle Biopsy (FNB) compared with~     conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of~     cases in which sufficient DNA is obtained to allow genomic profiling and whole exome~     sequencing.~   "
28931|NCT02678429|"~     Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time~     intensive process. Using an atlas created using functional tremor responses in the operating~     room to determine the optimal settings would lead to a faster response for the patient and~     improved quality of life.~   "
28932|NCT02678416|"~     Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain~     model~   "
28933|NCT02678403|"~     Purpose: The investigators team recently carried out a proof of concept study testing the~     efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In~     this randomized study, the investigators found that TENS significantly delayed pain onset~     and increased the pain-free walking distance in patients with class II PAD. From these~     encouraging results, the investigators now seek to assess the efficacy of an intervention~     that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD~     (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized~     controlled trial / double blinding.~   "
28934|NCT02678390|"~     The aim of this study is to compare the effect on ketone production of dietary an MCT~     supplement combined or not with physical exercise in two groups of women (N=10/group),~     healthy adults and patients with prediabetes. After an evaluation of the metabolism (a~     4-hour visit with multiple blood samples) at the beginning of the study, all the~     participants are taken for one-week the MCT supplement alone follow by a one-week period of~     taking the MCT supplement in combination with physical exercise. At the end of each period~     of time, the 4-hour visit for the evaluation of the metabolism is repeated.~   "
28935|NCT02678377|"~     This double-blind randomized controlled trial seeks to find a better treatment for women~     with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is~     to determine whether midurethral sling surgery combined with injections of~     onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of~     mixed urinary incontinence better than sling surgery alone.~   "
28936|NCT02678364|"~     While there have been a considerable number of studies on the impact of additional vitamin D~     in the diets of hens on the resulting egg vitamin D content, the effect of consumption of~     such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been~     tested in a RCT.~   "
28937|NCT02678351|"~     This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen~     (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors~     in patients with prostate cancer undergoing surgery that tend to spread quickly~     (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures,~     such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease~     has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have~     specific receptors, and may allow doctors to see smaller tumors than the standard of care~     contrast-enhanced computed tomography (CT) or MRI scan.~   "
28938|NCT02678338|"~     This phase I trial studies the side effects and best dose of anti-cluster of differentiation~     (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with acute myeloid leukemia that~     has returned after a period of improvement (relapsed) or has not responded to previous~     treatment (refractory). Monoclonal antibodies, such as anti-CD47 monoclonal antibody~     Hu5F9-G4, block cancer growth in different ways by targeting certain cells.~   "
28939|NCT02678325|"~     The objective of this study is to compare the difference in daily protein intake of~     critically ill patients in two standardized enteral nutrition formulas (20% versus 33%~     percent) with the same caloric density of 1.2 kcal/ml.~      The total amount of protein taken in on day four after starting the early enteral feeding is~     defined as primary endpoint.~   "
28940|NCT02678312|"~     This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate~     the way the body absorbs, distributes and removes the drug LCZ696. This will help determine~     the proper dose of LCZ696 for Part 2 of the study.~      The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril~     in pediatric heart failure patients over 52 weeks of treatment.~   "
28941|NCT02678299|"~     This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in~     combination with bendamsutine, etoposide and , for CD20 positive B-cell lymphomas, rituximab~     (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.~   "
28942|NCT02678286|"~     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in~     subjects with acute moderate to severe pain following abdominoplasty surgery.~   "
28943|NCT02678273|"~     The investigators will provide an integrated community of care to a socioeconomically~     disadvantaged population. This included an extended cycle of care from tertiary care to~     primary care and linkages with social care agencies in the community.~   "
28944|NCT02678260|"~     The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics~     (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to~     Japanese patients.~   "
28945|NCT02678247|"~     The overall objective of this study is to provide a more comfortable and functional~     prosthetic socket for persons with transfemoral amputation that will ultimately improve~     their quality of life.~   "
28946|NCT02678234|"~     The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder~     for oral solution in the Russian population as compared to an untreated group to support the~     indication of Short term relief of the symptoms of colds, chills and influenza, including~     mild to moderate pain, fever and nasal congestion.~   "
28947|NCT02678221|"~     Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or~     estimated fetal weight (EFW) < 10th centile. In asymmetrical IUGR the parameter classically~     affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates~     approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and~     mortality. This is particularly due to premature delivery, both for fetal and for secondary~     maternal indications such as the development of pre-eclampsia.~      Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and~     placental abruption have been implicated in more than 50% of iatrogenic premature births.~     For this reason, the problem of severe IUGR forms a substantial portion of the population~     that tertiary care centres care for.~      The effect of early-onset IUGR is particularly significant: of those born alive, less than a~     third will survive their neonatal intensive care unit (NICU) stay without significant~     neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very~     remote from term (<28 weeks' gestation) vary from 7% to 33%.~      As these early-onset IUGR children are born very preterm, there are significant risks of~     neonatal mortality, major and minor morbidity, and long-term health sequelae.~      The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests~     compromised uteroplacental circulation and placental hypoperfusion. Currently there are no~     specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific~     interventions include primarily lifestyle modifications, such as reducing or stopping work,~     stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance.~     These interventions, which are not supported by evidence from randomized trials, are used in~     the belief that rest will enhance the uteroplacental circulation at the expense of that to~     the glutei and quadriceps muscles.~      There is evidence from ex vivo and animal models of growth restriction that the~     phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves~     uteroplacental blood flow (umbilical artery, uterine artery).~   "
28948|NCT02678208|"~     Postpartum hemorrhage is the most common cause of maternal death across the world,~     responsible for more than 25% of maternal deaths annually. Although effective tools for~     prevention and treatment of are available, most are not feasible or practical for use in the~     developing world where many births still occur at home with untrained birth attendants .~     primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24~     hours of delivery of the fetus which affects the general condition.~      Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide ,~     reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of~     long-term severe morbidity, and approximately 12% of women who survive postpartum~     hemorrhagewill have severe anemia.~      Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of~     the activation of plasminogen to plasmin. At much higher concentrations it is a~     non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in~     plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase~     6-40 times greater than that of aminocaproic acid.~   "
28949|NCT02678195|"~     This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in~     children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and~     then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.~   "
28950|NCT02678182|"~     To evaluate the efficacy of maintenance therapies following completion of standard~     first-line chemotherapy in patients with locally advanced or metastatic HER-2 positive or~     HER-2 negative oesophago-gastric adenocarcinomas.~   "
28951|NCT02678169|"~     Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion~     Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours~     from symptom onset with an acute ischemic stroke (within the internal carotid artery and~     internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation~     large vessel occlusion (LVO) will be treated using the ADAPT technique with~     thrombo-aspiration as first intention and site routine practice.~   "
28952|NCT02678156|"~     The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the~     performance of Lyoplant® Onlay. To assess the performance of the product, various safety and~     efficacy parameters have been selected.~   "
28983|NCT02677753|"~     The investigators propose a randomized control trial comparing the rate of implantation of~     the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without~     fluoroscopic guidance.~   "
28953|NCT02678143|"~     The aim of this study is to evaluate the overall safety and feasibility of using~     haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT)~     for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative~     preparative regimen consisting of total body irradiation (TBI), cyclophosphamide and~     alemtuzumab and graft vs. host disease (GvHD) prophylaxis consisting of post-transplant~     cyclophosphamide (PT-Cy), mycophenolate mofetil (MMF), and sirolimus. The investigators~     anticipate that this approach will expand the donor pool and offer a safe and less toxic~     curative intervention.~   "
28954|NCT02678130|"~     The purpose of this post-approval study is to demonstrate that the InterFuse T modular~     lumbar interbody device is at least equal in safety and efficacy to other (standard of care)~     TLIF devices.~   "
28955|NCT02678117|"~     This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or~     magnesium sulphate or a combination of both drugs to decrease postoperative morphine~     consumption and pain intensity in the first 24 hours in postoperative period . quarter of~     patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter~     receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes~     preoperatively , other quarter receive combination of both drugs , the last quarter receive~     placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate~     intraoperatively~   "
28956|NCT02678104|"~     A prospective randomized parallel trial will be carried out on 100 patients who have~     extraction of single molar tooth. Teeth extractions will be done under local anesthesia. The~     patients will be divided randomly into two parallel groups. Group 1: The patients will start~     using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group~     2: After extraction, Manuka Honey will be applied topically into the extraction socket.~     Postoperative instructions will be given for all patients in addition to the prescription of~     ibuprofen 600 mg every 8 hours for 3 days.~      Re-evaluation:~      Postoperative day 3: tenderness with probing the socket, empty socket, food debris,~     halitosis and assessment of pain. For group 2, the intra-alveolar application of honey will~     be repeated. Re-evaluation will be repeated in the seventh post-operative day. Acute~     alveolar osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and~     4th days with pain or tenderness in the socket with probing, empty socket and food debris~     with or without halitosis.~   "
28957|NCT02678091|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      Quantitative analysis of the ultrasound exam with doppler of those masses could identify~     diagnostic criteria, especially for the lacrimal gland, easily explorable.~   "
28958|NCT02678078|"~     Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from~     stage 4 cancer patients, the investigators will evaluate and characterize the metastatic~     cells.~   "
28959|NCT02678065|"~     The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for~     the treatment of popliteal lesions in comparison with literature results of stent treatment~     in popliteal lesions~   "
28960|NCT02678052|"~     The purpose of this study is to assess the prevalence of major structural birth defects in~     infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed~     to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other~     biologic agents.~   "
28961|NCT02678039|"~     This is a prospective, randomized, controlled, and single blinded study. All work performed~     at Dartmouth-Hitchcock Medical Center, a tertiary care and level one trauma center for the~     state of New Hampshire with 28 operative suites. 100 patients scheduled to undergo~     thoracotomies are randomized to receive an epidural placed (for postoperative pain control)~     using either a traditional approach by feeling the spine for landmarks or using fluoroscopic~     X-ray guidance. Randomization is blinded to both the anesthesia team caring for the patient~     in the operating room and to one member of the acute pain team who follows the patient after~     surgery and is responsible for evaluating post operative pain control (dermatomal~     distribution of sensory blockade and visual analog scale) and pulmonary function (incentive~     spirometer use). All patients receive a standardized epidural infusion with local anesthetic~     and additional pain medications as needed.~   "
28962|NCT02678026|"~     Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB)~     who developed a dilated cervix detected by manual exam in the second trimester. In~     contemporary practice, there are three possible indications for cerclage. History-indicated~     cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on~     poor prior obstetrical history, e.g. multiple second trimester losses due to painless~     dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually~     between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) < 25mm in a woman~     with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed~     usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected~     on physical (manual) examination.~      Randomized trials and meta-analysis of these have shown that UIC is associated with~     significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for~     history-indicated cerclage and physical exam-indicated cerclage is limited. In the United~     States, the national data shows that the rate of cerclage has decreased in the last few~     years. The indications of placement of cerclage have recently changed, and so it is~     important to evaluate how many women are getting this procedure. With the recent completion~     of clinical trials, it is plausible that obstetricians and perinatologists may have become~     more selective in terms of the best candidates for cerclage.~      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as~     adjuctive therapy in women with UIC~   "
30661|NCT02655770|"~     The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective~     in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac~     MRI. Secondary if the treatment has any effect on the perfusion of the heart on a~     cardiac-MRI.~   "
28963|NCT02678013|"~     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of~     cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with~     a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for~     intrahepatic HCC but with a small proportion of resection rate because of the poor~     functional liver reserve and postoperative complications. Radiofrequency ablation(RFA) is~     becoming the main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for~     recurrent HCC has been reported to be comparable to those achieved by surgery with minimal,~     but higher local recurrence rate after RFA. It has been reported that immunotherapy in~     patients who underwent curative treatment for HCC, adjuvant immunotherapy with activated CIK~     cells increased recurrence-free and overall survival. But there is little evidence for~     adjuvant immunotherapy of recurrence HCC. Cytotoxic T lymphocytes(CTL), a kind of effective~     T cells that specific recognizing and killing antigen targeted cells through cloning~     amplification after receiving antigen information from antigen presented cell and playing~     key role to clear cancerous cells. So our hypothesis is that RFA combined with immunotherapy~     (Highly-purified CTL) is superior to RFA for recurrent HCC. The aim of this prospective~     study is to compare the outcome of RFA combined with immunotherapy (Highly-purified CTL)~     with RFA for small recurrent HCC after partial hepatectomy.~   "
28964|NCT02678000|"~     This is a randomized, double-blind, parallel group, placebo-controlled study, in two~     sequential parts to evaluate the renal safety, tolerability and pharmacokinetics of LHW090~     in patients with moderately impaired renal function.~   "
28965|NCT02677987|"~     Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere~     with quality of life and can linger long after treatment has ended, yet research examining~     cognitive rehabilitation approaches has produced limited clinical benefit. The proposed~     study will provide information about systematic light exposure for the treatment of~     cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will~     investigate how it works. This study would facilitate the development of this potential~     treatment, giving health care providers and cancer survivors a much-needed tool to help with~     cancer-related cognitive impairment.~   "
28966|NCT02677974|"~     The purpose of the proposed study is to assess the occurrence of bleeding, valve-related~     thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when~     targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a~     5-year follow-up period. The objective will be to compare adverse event rates for patients~     in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for~     use to rates from the previous IDE trial (G050208).~   "
28967|NCT02677961|"~     Translational studies in cancer research can be impeded by the lack of high-quality clinical~     data that can be correlated with research questions. This is particularly true in the case~     of rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this~     study to create a prospective EHR-based clinical registry for individuals with bone and~     soft-tissue tumors.~   "
28968|NCT02677948|"~     This study combines two drugs in the treatment of relapsed/refractory chronic lymphocytic~     leukemia (CLL) and small lymphocytic lymphoma (SLL). Investigators are proposing combining~     ibrutinib, an orally-administered, small molecule inhibitor of Bruton's tyrosine kinase (FDA~     approved for the treatment of relapsed/refractory CLL), with pacritinib, a novel JAK2-FLT3~     inhibitor that has shown activity in relapsed lymphoma, including CLL/SLL. Investigators~     will first demonstrate the safety and tolerability of Pacritinib when combined with~     Ibrutinib in a phase I study, which will help establish the MTD (Maximum Tolerated Dose)of~     Pacritinib when combined with Ibrutinib. Once the optimal dose of Pacritinib is established~     in the phase I setting, a phase II evaluation will seek to establish the efficacy of the~     combination of Pacritinib with Ibrutinib. Patients will receive continuous treatment until~     progressive disease and will be followed while on study treatment for a total of 2 years.~   "
28969|NCT02677935|"~     Worldwide, headache disorders are among the most common medical conditions. Many people with~     headache need not experience further pain if the diagnosis and treatment are correct. Most~     patients do not have correct diagnosis and treatment. This study tested a model for~     treatment of people with headache disorders at primary health-care level in rural areas of~     Haryana, India.~   "
28970|NCT02677922|"~     This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety~     and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine~     in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The~     study population consists of subjects who are not candidates to receive intensive Inductive~     chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage~     and a Phase 2 randomized stage.~   "
28971|NCT02677909|"~     In this study, we aim to conduct a pilot test of the AbStats device. The v2.0 prototype is a~     low-profile set of sensors that fits externally around the abdomen and is embedded with~     specialized wireless sensors. The device continuously, safely, and comfortably monitors~     intraabdominal acoustic signals, and stores the data in a HIPAA compliant software system.~      We will focus this trial on a high-impact inpatient population: ileus in the surgical~     critical care unit. We will compare the device's signal profiles in patients with ileus vs~     those who tolerate feeding without high gastric feed residual. Our study will have the~     following specific aims:~      Specific Aim #1: To measure the sensitivity, specificity, positive predictive value (PPV),~     and negative predictive value (NPV) of initiation day (PID 0) AGIS signals in predicting~     PID #1 feeding failure. Specific Aim #2: Among patients tolerating feeds on PID #1, to~     measure the sensitivity, specificity, PPV, and NPV of AGIS in predicting feeding failure on~     subsequent icu days.~   "
28972|NCT02677896|"~     The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen~     deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based~     on central review. The study will also evaluate the safety of enzalutamide plus ADT in~     mHSPC.~   "
28984|NCT02677740|"~     The aim of this project is to increase our understanding of how two different protocols of~     repetitive transcranial magnetic stimulation (rTMS), inhibitory (1 Hz) and excitatory (5~     Hz), applied over the primary motor cortex of the presumed dominant hemisphere, affect~     functional connectivity and neurochemistry in the brain.~   "
30662|NCT02655757|"~     This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor,~     on Progression of Coronary Intermediate Lesion.~   "
28973|NCT02677883|"~     This randomized controlled trial attempts to determine whether the measurement of pleural~     pressures during therapeutic thoracentesis affects the development of chest discomfort after~     the procedure. During thoracentesis, pleural fluid is drained from the pleural space,~     resulting in lung expansion. In some cases, the lung is not completely re-expandable, in~     which case continued drainage results in the development of negative pleural pressures and~     chest discomfort. Negative pleural pressures may also result in other complications such as~     re-expansion pulmonary edema and pneumothorax. The identification of negative pleural~     pressures via manometry during the procedure may lead to a reduction in the complication~     rate.~   "
28974|NCT02677870|"~     The purpose of this study is to determine if Amish patients with PKU show responsiveness~     after a high dose, prolonged Saproterin trial. The population of interest has a high~     frequency of a specific splice site mutation, the 1066-11G>A mutation. This splice site~     mutation activates a cryptic splice site resulting in an in frame insertion of 9 nucleotides~     preceding exon 11. This leads to protein conformational changes and abrogation of function.~     Previous studies of this genotype have indicated <1% residual activity of the PAH enzyme and~     an insignificant responsiveness to Saproterin. However, in this specific study Phe levels~     were evaluated only over 24 hours after a single-dose BH4 challenge at the standard dose of~     20mg/kg.~      Based on new clinical information, the investigators hypothesize that if given a prolonged~     trial of Saproterin at a higher dose, Amish patients with PKU, specifically those homozygous~     for the c.1066-11G>A mutation, will have a significant reduction in Phe levels or an~     increase in Phe tolerance and/or improvement in executive functioning and quality of life.~   "
28975|NCT02677857|"~     At this time, no study has examined the effect of a lifestyle intervention with a reduced~     Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic~     dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with~     University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to~     randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II,~     or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in >~     8 hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month~     conditions:~        1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);~        2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to~          > 200 min/wk and reduce SB by 2 hrs/day); or~        3. weight management education materials provided via mailed newsletter (Newsletter).~      Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500~     kcal/day], low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits,~     vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting~     activity and diet goals. Dependent variables, measured at 0 and 3 months, include~     objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB;~     percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP)~     (biomarkers of cancer prognosis that have been found to be positively related to SB and/or~     adiposity); diet; body composition; and fitness.~   "
28976|NCT02677844|"~     The purposes of this study are to determine:~        -  The effect of single increasing doses of the study drug, abemaciclib, on healthy~          participants.~        -  The relationship between the amount of abemaciclib and the electrical tracing of the~          heart rhythm when abemaciclib is given.~        -  How much abemaciclib is found in the bloodstream and how long the body takes to get rid~          of it.~      Information about any side effects that occur will be collected. The study will enroll two~     groups (cohorts) of participants. Each group will complete 4 study periods. This study is~     expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All~     participants will undergo a follow-up assessment approximately 21 days after administration~     of their final dose of study drug.~   "
28977|NCT02677831|"~     The general aim of this study is to establish a longitudinal cohort of older persons in~     order to examine the physiological, environmental and genetic risk factors for physical~     disability, frailty, cardiovascular disease, and neuropsychiatric disorders in older persons~     and to examine the benefit of healthy lifestyles. The findings from this study will provide~     information necessary for the development of effective health policy for aging people.~   "
28978|NCT02677818|"~     The purpose of this study is to determine whether Plasma Factor VIII Levels are related to~     the treatment of bleeding in ischemic stroke（IS）.~   "
28979|NCT02677805|"~     The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of~     glabellar lines in comparison with placebo, including efficacy after repeat treatments and~     long term safety.~   "
28980|NCT02677792|"~     The purpose of the current study is examine the feasibility and efficacy of providing a~     behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending~     a multidisciplinary pediatric obesity clinic and their parents. Participating families will~     complete assessments consisting of weight status, dietary intake, physical activity,~     health-related quality of life, psychological functioning, home-food environment, parenting~     skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month~     post-treatment follow-up (Month 5). Family attendance data will be collected during the~     behavioral family intervention and children and parents will complete a treatment~     satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C,~     glucose) routinely assessed through standard medical care in the multidisciplinary pediatric~     obesity clinic will be obtained from child medical charts.~   "
28981|NCT02677779|"~     The study is aimed at comparing debridement either with CO2 laser or traditional surgery in~     patients with infected diabetic foot ulcers. The principal endpoint is bacterial load~     immediately after treatment.~   "
28982|NCT02677766|"~     To date, there are no studies that demonstrate that the intervention of Occupational Therapy~     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical~     and functional outcome for the patient. For this reason, the investigators propose one~     randomized controlled trial that will compare the group receiving the intervention of OT and~     the control group, to quantify the level of performance and satisfaction in the activities~     of interest of the patient, identified through the COPM. The hypothesis is that the benefit~     may be higher, as clinically relevant, in the group of complex patients treated with the~     proposed intervention of OT compared to those receiving the usual rehabilitation therapy.~   "
28985|NCT02677727|"~     This is a prospective observational study investigating the incidence, characteristics of,~     and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20~     instrument. Approximately 60 patients will be collected for this study. The duration of this~     study will be up to 18 months for each patient. This study will complement a current R01~     funded trial (Platinum Study) which evaluates the genetic predisposition of chronic~     neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a~     similar patient population, it does not evaluate the natural history of platinum induced~     neuropathy during active treatment and the first 12 months post chemotherapy. This trial~     will fill this gap and add to the investigators knowledge for both natural history and~     genetic predisposition of platinum neurotoxicity.~   "
28986|NCT02677714|"~     The changes to the heart can be evaluated during the course of the chemotherapy with cardiac~     magnetic resonance imaging (CMRI) and left ventricular (LV) nuclear scans to look at left~     ventricular ejection fraction (LVEF). Serial LVEF evaluation can detect cardiotoxicity,~     usually after cardiac damage is present and most likely irreversible. Each patient's~     sensitivity to the chemotherapy is different.~      The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to~     image the cell damage from apoptosis, or cell death, in the heart from the effects of the~     chemotherapy. This may allow doctors to identify patients developing cardiotoxicity in the~     future. These patients may then benefit from changes in chemotherapy with dose alterations~     or changes to alternative drugs.~   "
28987|NCT02677701|"~     This is a study to examine the effect of combining chronic oral azithromycin with inhaled~     tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically~     infected with P. aeruginosa.~   "
28988|NCT02677688|"~     EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective~     control in EBV infection and altered both B and T immune responses to this virus The main~     objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of~     autologous EBV specific CTL adoptive transfer in adult patients with serologically active~     SLE~   "
28989|NCT02677675|"~     The objective of this study was to determine the effectiveness of mobile phone technology~     (SMS and telephone call reminders) in improving adherence and treatment outcomes among HIV~     positive patients on ART in Malaysia.~   "
28990|NCT02677662|"~     Air pollution continues to be a key global issue with many governments focusing great~     attention on air quality legislation because of its harmful environmental and health~     impacts. Whilst there is much that remains unknown about the mechanisms underlying the~     negative health effects of air pollution, it is generally acknowledged that air pollution~     exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality~     and morbidity. The current study will investigate systemic effects during a 72 hour period~     after a controlled diesel exhaust exposure.~   "
28991|NCT02677649|"~     Composition and diversity of intestinal microbiota that are subject to the influence of diet~     have a significant impact on health in the gut and whole body via complex interactions~     between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper~     gastrointestinal tract and reach the colon, where they may have a reciprocal relationship~     with microbiota. Because how polyphenols mediate gut health and reduce risk for other~     pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding~     study to examine the impact of polyphenols and other constituents in the free dried whole~     cranberry powder (FWCP) on composition and diversity of gut microbiota, as well as to~     substantiate bioavailability of cranberry polyphenols. The central hypothesis underlying the~     proposed research is that FWCP polyphenols will diminish the magnitude of a plant food free~     diet induced increase in Alistipes, Bilophila and Bacteroides and will increase~     Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale~     groups. The proposed research is novel as no study has examined the specific impact of FWCP~     polyphenols incorporated into a plant food free diet on gut microbiota. This proposed study~     is innovative because the positive results will demonstrate with a high degree of confidence~     that the impact of FWCP constituents on production of beneficial short chain fatty acids,~     carcinogenic bile acids, and atherogenic trimethylamine. The results generated from the~     study using a plant food free dietary regimen as the background diet will provide definite~     proof on microbial modulating actions of FWCP, inform mechanism of actions in urinary tract~     infection (UTI), and be used to formulate messages in consumer communications for gut~     health.~   "
28992|NCT02677636|"~     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3~     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up~   "
28993|NCT02677623|"~     Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to~     identify the opening of the ureters to ensure that they are working correctly. Historically,~     indigo carmine, an intravenous medication that dyes the urine blue, has been used to help~     visualize the opening of the ureters with cystoscopy which is a camera placed inside the~     bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus,~     investigators need to evaluate other methods for assessing ureteral patency. Ideal~     alternatives are agents that are low-risk, inexpensive, provide comparable visualization,~     are readily available and are easy to use.~      Examples of such agents currently being used to evaluate the ureters, include oral pyridium,~     IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters~     by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by~     having a different viscosity to urine such as mannitol. This study will compare three~     methods of evaluating ureteral patency at time of cystoscopy compared to no method:~     mannitol, sodium fluorescein, and pyridium.~   "
28994|NCT02677610|"~     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3~     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.~   "
28995|NCT02677597|"~     Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal~     Squamous Cell Carcinoma~   "
28996|NCT02677584|"~     Investigators hypothesized that the timing of caffeine administration in either prophylaxis~     or treatment of apnea of prematurity will affect the apnea response to caffeine~   "
30682|NCT02655497|"~     The purpose of this study is to determine the effectiveness of cognitive strategies in~     improving participation in daily activities within older adults who report subjective~     cognitive decline.~   "
28997|NCT02677571|"~     Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as~     analgesic option for major breast surgery.~      102 patients undergoing reconstruction breast surgery will be randomized into two groups:~     Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6)~     performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.~      Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse~     if pain > 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block~     performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.~      Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse~     if pain > 5/10 at rest~      Primary Outcome Measures:~      Morphine consumption (mg) (Time Frame: 24 hours) in two Groups~      Secondary Outcome Measures:~      Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the~     first 24 hours postoperatively.~      Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain~     during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids~     intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and~     60.~   "
28998|NCT02677558|"~     The purpose of this study is to determine the impact of obesity in pregnancy on maternal~     cardiac function. For this, morbidly obese term pregnant women (study group) and term~     pregnant women of normal weight are assessed by transthoracic echocardiography.~   "
28999|NCT02677545|"~     Patients with symptomatic or asymptomatic carotid stenosis in whom carotid artery stenting~     is planned are randomised between antiplatelet therapy with ticagrelor plus aspirin or~     clopidogrel plus aspirin and examined with brain MRI before and after stent treatment. The~     proportion of patients with new ischaemic lesions on MRI after treatment is compared between~     the two groups.~   "
29000|NCT02677532|"~     The aim of the study is to determine wether continuous wound infusion with local anaesthetic~     plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided~     with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients~     undergoing open abdominal aortic aneurism repair.~   "
29001|NCT02677519|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5~     years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).~      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events~     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The~     primary objective of this study is to evaluate the long-term (12-month) safety and~     tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed~     with ADHD.~      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events~     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values~     and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and~     quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).~      Secondary objectives include assessment of long-term efficacy of Aptensio XR®.~      Secondary measures include:~        -  Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale~          Preschool Version (ADHD-RS-IV Preschool Version)~        -  Clinical Global Impressions-Severity Scale (CGI-S )~        -  Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]~   "
29002|NCT02677506|"~     This study compares the infraclavicular approach to supraclavicular approach of brachial~     plexus block for elbow surgery.~   "
29003|NCT02677493|"~     This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza~     Vaccine Inj.' in healthy male and female adults at the age of 19 or older.~   "
29004|NCT02677480|"~     The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥~     4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9~     used placebo tablets and gel. The salivary secretion rates were measured and microbial~     samples collected and analysed using cultivation technique twice both at baseline and at the~     3-month follow up (1-2 weeks between the appointments).~   "
29005|NCT02677467|"~     Investigators examine blood-pressure variance, several cardiovascular risk factors of~     patient with epistaxis. As a result of collected data, investigators look into correlation~     between epistaxis and hypertensive cardiovascular disorder.~   "
29006|NCT02677454|"~     To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle~     Libre, used today in clinical practice in Sweden in estimating plasma glucose levels. Data~     will be collected in ambulatory patients with type 1 diabetes to determine safety, accuracy,~     and reliability.~   "
29007|NCT02677441|"~     This study will evaluate the non-inferiority of conservative management for~     acromioclavicular clavicle disjunction, compared with surgical management. Half of patients~     will be treated with a specific standardized rehabilitation protocol, and the other half~     will be treated with coracoclavicular and acromioclavicular fixation, followed by a another~     specific standardized rehabilitation protocol.~      Outcomes:~      The primary outcome is the non-inferiority of the conservative management over surgical~     management of Rockwood III-V Acute acromioclavicular joint dislocation (ACJD) without PICCAT~     with American Shoulder and Elbow Surgeons (ASES score) at one year. If the non-inferiority~     is reached, the non-inferiority of the conservative management over surgical the management~     of Rockwood III-V ACJD with PICCAT using ASES score at one year will be evaluated.~      Secondary outcomes were radiological criteria (i.e. comparison of ipsilateral and~     contralateral coracoclavicular distance on anterior view; and dynamic posterior shaft of the~     cross-body adduction Basamania/Alexander view) return to sports, work absenteeism,~     complication rate, cosmetic results, patients satisfaction, Constant score, Single Assesment~     Numeric Evaluation (SANE) score, Acromioclavicular Joint Instability (ACJI) score, ASES~     score at others timepoints, and range of motion of the implicated shoulder. Finally,~     multivariable regression analysis will be performed in order to evaluate the impact of~     predictors of interest on ASES score at one year.~   "
29032|NCT02677116|"~     The main purpose of this study is to evaluate the safety of different doses of olaratumab~     and to determine which dose should be used for future pediatric studies. The present study~     is open to children with advanced cancer or cancer that has spread to another part of the~     body. The study has two parts. In each part, a specific dose of olaratumab will be given for~     21 days, followed by one of three standard chemotherapy regimens. Participants will only~     enroll in one part.~   "
29033|NCT02677103|"~     Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by~     inflammation around calcium hydroxyapatite crystal deposits, usually located in the~     supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals~     between 30 and 50 years of age, is painful in 50% of patients and frequently leads to~     considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific~     stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of~     calific deposits), and a postcalcific stage (reconstitution of matrix).~      Classifications of calcific tendinitis have been proposed previously. Gartner proposed a~     classification based on plain films of the shoulder: type I deposits were sharply outlined~     and densely structured. Type III deposits had a cloudy outline and were transparent in~     structure. Type II deposits were features of both.4 Type III plaques have a tendency to~     resorb. Due to the progress of musculoskeletal ultrasound over the past decade,~     classification of the calcific tendinitis based on ultrasound findings was also proposed:~     arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2~     separated echogenic spots or plaques with or without shadowing), nodular (an echogenic~     nodule without shadowing), and cystic (a bold echogenic wall with an anechoic area).5~     Plaques that appear fragmented, nodular, or cystic on ultrasound are considered in the~     resorptive phase.~      The treatment of patients with calcific tendinitis is typically conservative. The reported~     success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after~     several months of conservative treatment, arthroscopic and open procedures are available to~     curette the calcium deposit, and additional subacromial decompression can be performed if~     necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT)~     has been postulated to be an effective treatment option for treating calcific tendinopathy~     of the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed.~     A radial shock wave is a low- to medium-energy shock wave that is pneumatically generated~     through acceleration of a projectile inside the handpiece of the treatment device and then~     transmitted radially from the tip of the applicator to the target zone. Radial shock wave~     showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In~     radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as~     occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative~     treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the~     calcific plaque, as shown in previous study.14,15 The new method has the advantage of being~     easily operative, cheap, safe, and has a proven high success rate. Although percutaneous~     needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of~     patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result~     in tendon injury.~      In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine~     needle repeated puncture is frequently used and shows promising results, however, scientific~     report has been rarely published before.18 The purpose of this study is to compare the~     efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and~     USNP in the treatment of calcific tendinitis of shoulder.~   "
29008|NCT02677428|"~     A significant portion of Veterans who apply for disability benefits have difficulty finding~     and sustaining employment, and are concerned that working for pay will jeopardize their~     receipt of service-connection benefits. In a completed clinical trial, Veterans who received~     Motivational Interview-formatted counseled about opportunities to work and receive~     service-connection went on to work for pay significantly more often than controls. The~     proposed clinical trial will test this counseling's efficacy when it is delivered by an~     automated computer program.~   "
29009|NCT02677415|"~     Recent observational studies have found an association between general anaesthesia and~     increased post-operative mortality in acute ischemic stroke patients undergoing endovascular~     treatment. It is unknown whether there is a causal relationship in this observation. The~     investigators are performing a large randomised trial of general versus local anaesthesia to~     definitively answer the question of whether anaesthetic type alters perioperative outcome.~   "
29010|NCT02677402|"~     Objectives In this study the investigators examined the changes in common femoral vein (CFV)~     and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold~     water immersion (CWI) and contrast water therapy (CWT).~      Design Ten professional handball players visited the laboratory on three occasions. At each~     visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in~     air (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes~     (~12°C to ~35°C) ratio), selected randomly.~      Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the~     end of 16 min immersion.~   "
29011|NCT02677389|"~     This randomized pilot clinical trial studies how well survivorship care plan works in~     promoting technology-based physical activity in breast or colorectal cancer survivors in~     Wisconsin. A survivorship care plan may help doctors to better understand how they can help~     people who have been diagnosed with cancer to become more physically active. It is not yet~     known whether a standardized cancer survivor plan used as part of routine care or a~     technology-based physical activity intervention is better in promoting physical activity in~     breast or colorectal cancer survivors.~   "
29012|NCT02677376|"~     To determine the feasibility and success rate of tumor tissue procurement using~     molecular-image-directed biopsies of responding and non-responding osseous metastases,~     measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.~   "
29013|NCT02677363|"~     Strength training can increase muscle mass and strength while improving bone density and~     reducing risk for osteoporosis and related fractures. Strength training can also lead to~     reduced risk for diabetes, heart disease, arthritis, depression, and obesity; and improves~     self-confidence, sleep and vitality. Research demonstrates that strength training is~     extremely effective in helping aging adults with chronic conditions prevent further onset of~     disease and, in many instances, actually reverse the disease process. In Stay Strong, Stay~     Healthy Program elderly subjects perform resistance exercise training (RET) twice every~     week. Past literature suggests that resistance training improved muscle activity, muscle~     strength, muscle mass, and bone mineral density and total body composition, and adiponectin,~     insulin sensitivity, fasting blood-glucose (BG), HbA1c1 (long-term marker of BG), blood~     pressure (BP), blood triglycerides (TGs) and low density lipoproteins (LDL) in healthy and~     diabetic subjects. The purpose of this study is to measure the changes in the above~     discussed variables after 8-weeks of resistance exercises.~   "
29014|NCT02677350|"~     To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal~     fistulizing Crohn disease.~      Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal~     fistulas will be included and will be scheduled to undergo peri-fistula injections after~     meeting all inclusion/exclusion criteria's at baseline.~      Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to~     undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be~     evaluated at baseline.~   "
29015|NCT02677337|"~     This study will consist of three parts: 1) a retrospective chart review of patients treated~     for mRCC from July 2013 until the start of the educational intervention; 2) an educational~     program for DCN community oncology providers and DCN community patients with mRCC, lasting 8~     - 10 months, and 3) a second retrospective chart review of patients treated for mRCC~     starting at the time of the educational intervention until the intervention is completed.~   "
29016|NCT02677324|"~     This research study is studying a targeted therapy as a possible treatment for relapsed or~     refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention~     ABT-199.~   "
29017|NCT02677311|"~     This is a prospective case control study. Participants will be enrolled as case subjects or~     control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The~     chemotherapeutic regimens will be determined per standard of care. Participants will receive~     GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic~     ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the~     interventions. The duration of the study will be approximately 12 months.The study time~     includes the time necessary for completion of most cancer treatments in this population,~     which approximates 8-12 months, and time to allow complete excretion of the Lupron from the~     systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O)~     axis. The results of the study will be used to guide a larger study evaluating the efficacy~     of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young~     subjects receiving chemoradiation.~   "
29018|NCT02677298|"~     The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of~     glabellar lines in comparison with placebo, including efficacy after repeat treatments and~     long term safety.~   "
29019|NCT02677285|"~     This study consists of two clinical series. With the first series investigators monitor the~     healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done~     with a purpose built patch that has electrodes in contact with the wound and reference~     electrodes.~      In the second series the investigators monitor closed operational wounds (breast~     reconstruction surgery patients) with bioimpedance measurements. This series is also~     conducted with bioimpedance measurements but the wounds are operational wounds.~      Both groups will have 20 patients.~   "
29034|NCT02677090|"~     Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years~     old.~   "
29020|NCT02677272|"~     According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle~     Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months~     or about 50% per year. These hospitalizations concern for half, transfers to emergency~     department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in~     France, confirm that intense flows between NH and ED. These studies also support the idea~     that these transfers to ED potentially expose some NH residents to iatrogenic complications,~     a risk of functional decline, an increased risk of mortality, and generate additional health~     costs. To transfer to ED residents who will benefit from emergency care and not to transfer~     to ED residents for whom this transfer generates a higher risk than the expected benefit is~     the goal to reach to guarantee the better quality of care for NH residents.~      Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or~     palliative care known before transferring to ED and / or the presence of advance directives~     of non-hospitalization in the resident's file. This is a clinical situation that could be~     managed by other means that the transfer to ED without loss of opportunity for the patient.~      The primary objective of our study is to determine the factors predisposing NH residents to~     inappropriate transfer to ED.~      Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by~     factors accessible to interventions such as the organization of the NH care system or by~     improving the management of some diseases in NH. Investigators also hypothesize that the~     cost of inappropriate transfers to the ED is considerable. Acknowledgement of costs~     generated by inappropriate transfers to ED would allow policy makers to make strategic~     decisions to improve care system.~   "
29021|NCT02677259|"~     Optimizing in vitro fertilization (IVF) success is more important than ever, in light of new~     public funding of IVF in Ontario, Canada. In patients undergoing IVF using~     gonadotropin-releasing hormone (GnRH) analogues, the luteal phase appears to be compromised,~     which may be a result of controlled-ovarian hyperstimulation, significant fluctuations in~     hormone levels, the impact of the oocyte retrieval process, or direct compromise of the~     corpus luteum. Progesterone support is definitely necessary during the luteal phase to~     facilitate implantation but whether estrogen supplementation is also needed remains unclear.~     The present study aims to determine whether estradiol support during the luteal phase~     improves clinical pregnancy rate in patients undergoing IVF.~   "
29022|NCT02677246|"~     Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone~     damages are caused by both a decrease of bone formation and an increase of bone destruction~     after BMT.For long term survivors, bone complications are major determinants of impaired~     quality of life. No standard treatment currently exists to prevent those bone injuries.~     Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in~     adults. This trial will study whether it is safe to prescribe Denosumab to children after~     BMT in the aim of preventing bone complications.~   "
29023|NCT02677233|"~     To find out if lower levels of vitamin D is more prevalent in preeclamptic women~   "
29024|NCT02677220|"~     The aim of this study is to investigate the clinical benefit for patients implanted with the~     Nucleus® CI532 cochlear implant.~      The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into~     the cochlea through a straightening sheath.~   "
29025|NCT02677207|"~     To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric~     performance and residual depressive symptoms in patients who have been diagnosed with~     unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major~     Depression or Manic Episode.~   "
29026|NCT02677194|"~     The aim of this study is to assess cutaneous healing process under LED exposition on 10~     healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.~   "
29027|NCT02677181|"~     The purpose of this study is to determine the efficacy and safety of combined ATG~     （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in~     matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).~   "
29028|NCT02677168|"~     The purpose of this study is to determine whether cNEP (continuous positive external~     pressure) is effective in treating obstructive sleep apnea~   "
29029|NCT02677155|"~     Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin's lymphoma and~     is often diagnosed in advanced incurable stage. In our previous trail, Lymvac-1, patients~     were treated with sequential intratumoral injections of low-dose rituximab and autologous~     dendritic cells, combined with local radiotherapy at the same site. The aim was to overcome~     tumor tolerance. In this trial, clinical responses correlated strongly with systemic~     anti-tumor CD8+ T-cell responses detected in blood after therapy. The primary aim of the~     planned study (Lymvac-2) is to significantly improve rates of immunological and clinical~     responses by adding iv anti-PD-1 antibody (Pembrolizumab) relative to the cohort of patients~     previously treated with intranodal immunotherapy without Pembrolizumab (Lymvac-1). The study~     includes 20 patients with untreated or relapsed FL.~   "
29030|NCT02677142|"~     Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly,~     treatment strategies vary widely depending on child's age, tumour location, its~     resectability and histology. As a group, however, the survival rate of childhood brain~     tumors has improved in recent years, resulting in an increased number of survivors returning~     to school and reintegrating into their communities. Survival for many of them, however, has~     also come with severe costs such as neurocognitive and academic difficulties. Cognitive~     rehabilitation strategies to address these deficits have been a major focus of recent~     research. Evidence is now also mounting for social competence deficits among this population~     which may persist into late adolescence and adulthood, thereby negatively affecting~     long-term survivorship. Thus, there is an urgency to identify psychosocial interventions,~     such as social skills programs, that can reduce the social competence deficits in childhood~     brain tumor survivors and, therefore, modify the course of these outcomes to ensure that~     survivors thrive and become productive members of society. To date, no rigorous social~     skills intervention trials have been undertaken to address the social difficulties of these~     survivors. The current proposal is the first study that aims to address this gap by~     evaluating the efficacy of an innovative, manualized, social skills intervention program~     developed for this population using a multi-centre Randomized Control Trial (RCT).~   "
29031|NCT02677129|"~     The study is a randomized controlled trial with the aim to examine the feasibility and the~     effects of a home-based exercise intervention program on activities of daily living (ADL) in~     patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment.~     Further outcomes include functional and body status, quality of life, body composition, and~     chemotherapy completion rate. Study participants will be randomized to an exercise~     intervention group or a wait-list control group~   "
29119|NCT02675985|"~     This study will investigate the safety and feasibility of early intensive physical therapy~     for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the~     neurological ICU and continue for 30 days or hospital discharge.~   "
29035|NCT02677077|"~     The primary objective of the study is to retrospectively investigate the proportion of~     participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions~     over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants~     with regular MRI follow-up, who have received natalizumab ≥24 month from two different~     observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2)~     approximately 70 participants from Belgium. The secondary objectives of this study are as~     follows: Brain volume change by various measures; Changes in the number and volume of~     magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and~     without brain volume change.~   "
29036|NCT02677064|"~     The investigators are doing this research study to assess the percentage of patients~     receiving stem cell transplantation for the type of blood cancer you have. They want to know~     how many patients get a transplant and why some patients do get a transplant while others do~     not. Also they want to explore why some patients elect not to undergo stem cell~     transplantation, when it is recommended by their physicians.~   "
29037|NCT02677051|"~     This study is a double blind treatment trial that will test if sulforaphane improves core~     symptoms in autism. The investigators expect to see clinical improvement in some of these~     areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators~     will be using a preparation that gives specific and reproducible amounts. The investigators~     will also test specific chemicals and genes needed for sulforaphane usage to try to~     understand differences in response.~   "
29038|NCT02677038|"~     The goal of this clinical research study is to learn if olaparib can help to control~     metastatic pancreatic cancer. The safety of this drug will also be studied.~   "
29039|NCT02677025|"~     This supplement study is an adaptation of the larger NIH-funded parent study, the Women's~     Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance~     standard HIV testing practices for alcohol and drug (AOD)-using women across the city of~     Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female~     adolescents who experience the greatest burden of new HIV infections and are currently~     underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the~     validation of both the instrument and adapted intervention.~   "
29040|NCT02677012|"~     During reconstructive surgery that involves AFG, fat tissue is removed from one part of the~     body (usually the abdomen or legs) and inserted into another part of the body. This fat must~     be cleaned and filtered (processed) before being inserted back into the body.~      The goal of this clinical research study is to compare 3 techniques for processing (fatty~     tissue that is collected during reconstructive surgery. Researchers want to compare the~     amount of fat processed and the length of time needed to complete AFG technique and surgery.~   "
29041|NCT02676999|"~     This project is set to describe by objective measures as the range of motion and~     weight-bearing ability of the distal radioulnar joint one to five years after primary~     implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and~     stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function,~     especially the pronation and supination. Unlike other ulnar endoprostheses that replace only~     the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser~     sigmoid notch, and is semi-constrained in design.~   "
29042|NCT02676986|"~     This study is being carried out to see if the antiandrogen enzalutamide has antitumour~     effects in early breast cancer.~      Enzalutamide blocks the action of androgens on the androgen receptor (AR) and may slow down~     or stop breast cancers growing. Enzalutamide is approved for the treatment of prostate~     cancer.~      The trial will be offered to patients who have just been diagnosed with early breast cancer~     and who are planned to have surgery in the next few weeks. The treatment will bridge the~     time between the diagnosis and surgery and will be given for 2- 4 weeks. To assess the~     effect of the treatment, small samples of breast cancer tissue will be analysed before the~     start and after treatment. The pre-treatment assessment will be done on archived tissue but~     patients might require an additional biopsy, if sufficient stored tumour tissue is not~     available. The end of treatment samples will be taken during surgery, unless the patient~     will receive medical treatment first instead of surgery which might mean additional biopsies~     of the breast cancer have to be taken. The trial has two cohorts. The cohort of patients~     with oestrogen receptor (ER) positive breast cancer will test if adding enzalutamide to~     exemestane is better at slowing the growth of breast cancer than exemestane alone. This~     cohort will recruit 141 evaluable post-menopausal patients with a tumour size of at least 1~     cm. The aromatase inhibitor exemestane is approved for the treatment of ER positive breast~     cancer. Blocking aromatase decreases oestrogens but can increase androgens. Enzalutamide is~     therefore added to block the action of androgens on the AR.~      In the second cohort of patients with triple negative breast cancer (TNBC), enzalutamide~     will be given alone to see if it can slow the growth tumours with androgen receptors. As~     only approximately 30% of TNBCs express the AR, a pre screening step will be included to~     test the tumour AR expression, before patients are approached for the ARB trial. The TNBC~     cohort will comprise 55 patients.~   "
29043|NCT02676973|"~     The study is a multi-center, randomized, surgical trial of women with symptomatic~     post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will~     compare the three available surgical treatments performed in usual practice. The purpose of~     this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs.~     Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced~     repairs. The primary outcome is measured over time (up to 60 months) using a survival~     analysis approach.~      The investigators hypothesize that treatment failure will not differ between vaginally and~     abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of~     implantation) will be superior to native tissue apical suspension.~   "
29044|NCT02676960|"~     The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI)~     instrument on children aged 6 months, 1 year, and 2 years. This procedure is usually done~     with sedation but the study will see if it can be done without sedation.~   "
29045|NCT02676947|"~     An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary~     arterial hypertension patients~   "
29046|NCT02676934|"~     the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for~     living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as~     effective as FGF control with less cost and more operator satisfaction.~   "
29047|NCT02676921|"~     The objectives of this study are :~        1. to test the the osteogenic potential of human maxillary sinus schneiderian membrane~          (hMSSM).~        2. To investigate the expression of mesenchymal stem cell marker (STRO-1), a marker of~          mesenchymal progenitor cells using flow cytometry, and Alkaline phosphate expression,~          Red alizarin and Von Kossa staining and quantitive PCR.~   "
29120|NCT02675972|"~     Previous studies on the association between blood pressure variation (BPV) in acute ischemic~     stroke and functional outcomes yield conflicting result. The obscured definition and~     measurement of BPV engenders considerable confounding factors, making it difficult to~     interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in~     acute non-cardiogenic ischemic stroke.~   "
29048|NCT02676908|"~     Compression stockings are traditionally worn for a period of time after varicose vein~     surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous~     ablation service. Patients come to the Veins Unit, receive oral sedation, have their veins~     treated with either laser or radiofrequency ablation plus phlebectomies* under local~     anaesthetic, recover for an hour and then go home. *Phlebectomy describes the technique of~     pulling out small varicose veins through small incisions in the overlying skin. The standard~     practice of the Veins Unit is to advise patients to wear class two compression stockings for~     four weeks post-operatively. Many patients would prefer a shorter period of time in~     stockings.~      The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be~     worn for after endovenous ablation?'~      Three trials have addressed this issue:~      Bakker looked at patients who wore stockings for either two or seven days after laser~     ablation only; the group who wore stockings for seven days fared better.~      Elderman looked at patients who either wore no stockings or stockings for two weeks after~     laser ablation only; the group who wore stockings for two weeks had less pain.~      Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after~     radiofrequency ablation only; there was no significant difference in post-op pain among~     groups.~      None of these trials included patients who had phlebectomies at the same time. This study~     aims to answer the question 'How long is it necessary to wear compression stockings for~     after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?'~     The investigators plan to divide 110 patients into two groups- either 'stockings for 2~     weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group).~      Pre-operatively, all patients will fill out a pain score and two short quality of life~     questionnaires, one specific to varicose veins. Post-operatively at home, all patients will~     be asked to keep a diary of pain and analgesia use. They will also document bruising at~     seven days on charts and on a visual scale. At their four week clinic review, all patients~     will be asked to fill out a pain and bruising score, a bruising chart and the two short~     quality of life questionnaires again.~      The group with the best pain, bruising and quality of life scores post-operatively will help~     guide duration of compression therapy for future patients.~   "
29049|NCT02676895|"~     The purpose of this study is to evaluate the safety and the immunogenicity of two different~     doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards~     testing of the GMMA vaccine in the vaccine target population of children from developing~     countries where shigellosis is endemic.~   "
29050|NCT02676882|"~     The purpose of this study is to assess the effectiveness of the EnBrace HR prenatal~     supplement in preventing depression in women with a history of depression who have decided~     to stop taking antidepressants during their pregnancy, or treating women who are currently~     in a depressive episode while pregnant or planning pregnancy.~   "
29051|NCT02676869|"~     The purpose of this study is to determine the safety, tolerability and recommended phase 2~     dose of a new drug, known as IMP321, in combination with pembrolizumab when given to~     patients with unresectable or metastatic melanoma.~   "
29052|NCT02676856|"~     The purpose of this study is to evaluate the efficacy of hematopoietic stem cell~     microtransplantation for in acute myeloid leukemia (AML)patients who can not receive~     hematopoietic stem cell transplantation (HSCT).~   "
29053|NCT02676843|"~     The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect~     depositions of a protein, called tau, in the brains of people with a mutation in the tau~     gene that causes deposition of the protein, and in people without the mutation. A single~     18F-AV-1451 scan will be performed on control subjects without MAPT mutations,~     presymptomatic mutation carriers, and symptomatic mutation carriers.~   "
29054|NCT02676830|"~     The purpose of this study is to Evaluation of absorption, metabolism, and excretion of~     [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects~   "
29055|NCT02676817|"~     The aim of the study is to construct and validate an endomicroscopic score correlated with~     microscopic inflammation activity in patients with UC.~      Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which~     offers the possibility to perform in vivo mucosal microscopic analysis in real time during~     endoscopy.~      Primary Objectives : Development and validation of a UC endomicroscopic score, after~     correlation between pCLE data and histological data using the Geboes' score as a gold~     standard during ulcerative colitis.~      Secondary Objectives:~        -  Identify predictive factors for the response to adalimumab.~        -  Identify predictive factors for recurrence in patients with UC in remission (Mayo score~          0 or 1).~        -  Safety of the pCLE procedure~   "
29056|NCT02676804|"~     This is a prospective, pre-post intervention study to evaluate the effect of a~     high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance,~     cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life~     for patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a~     composite measure of cognitive function and the Timed Up and Go (TUG).~   "
29057|NCT02676791|"~     The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel~     arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes~     in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is~     defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant~     recurrence, disease-specific survival and esophageal cancer specific survival.~   "
29058|NCT02676778|"~     The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in~     participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous~     T-cell lymphoma (CTCL).~   "
29059|NCT02676765|"~     The purpose of this study is to determine if sublingual allergen immunotherapy tablets work~     by inducing a state of desensitization in mast cells and basophils.~   "
29060|NCT02676752|"~     This research trial studies skin/soft tissue elasticity in head and neck cancer survivors~     with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck~     cancer which may lead to skin tightness, pain, and body image issues. Early detection of~     lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave~     elastography is a technique that provides a quantitative measure of stiffness using a push~     pulse to generate shear waves within the tissues. Conventional imaging techniques are then~     used to monitor the shear waves generated through the tissue to calculate the shear wave~     speed. Shear wave elastography may help obtain an early and accurate measurement of tissue~     elasticity in head and neck cancer survivors.~   "
29061|NCT02676739|"~     This 12 week randomized placebo-controlled study will compare the effects of 10 mg and 20 mg~     of a mixed amphetamine salt, extended release medication (trade name Adderall XR) to placebo~     on objective measures of processing speed and memory, as well as on self-reported measures~     of cognition and quality of life. To be enrolled in the study, MS subjects must demonstrate~     impaired processing speed on the Symbol Digit Modalities Test (SDMT).~   "
29062|NCT02676726|"~     The purpose of this study is to determine whether or not there are more complications in the~     extraperitoneal compared with the transperitoneal approach for laparoscopic aortic~     lymphadenectomy for the surgical staging of endometrial or ovarian cancer~   "
32138|NCT02636452|"~     In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom.~     Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate~     cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.~   "
29063|NCT02676713|"~     Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are~     infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and~     moderate endometriosis increases live birth or ongoing pregnancy rates. There was no~     evidence of benefit for post-surgical hormonal suppression of endometriosis compared to~     surgery alone for the outcomes of pregnancy rates. Past studies have confirmed that Chinese~     herbal medicine can inhibit post-surgical endometriosis recurrence, increase pregnancy~     rate.This study evaluates the efficacy and safety of Traditional Chinese Medicine Sequential~     Treatment of endometriosis-associated infertility. The study objective is to confirm that~     clinical pregnancy rate of patients with endometriosis-associated infertility~     post-conservative surgery accepting Chinese medicine activating blood, dredging liver and~     nourishing kidney sequential treatment is higher than expectant treatment.~   "
29064|NCT02676700|"~     This study examines the effect of adding so called Kaatsu training to pelvic floor muscle~     training. Half the participants will perform Kaatsu training on their thigh muscles followed~     by pelvic floor muscle training. The other half will receive pelvic floor muscle training~     alone.~   "
29065|NCT02676687|"~     Gliomas, especially high grade gliomas and diffuse low grade gliomas, are characterized by~     their infiltrative nature. Recently, a new conception of supratotal resection has been~     proposed. Given the lack of prospective supporting data, the correlation between supratotal~     resection and the survival of patients with glioma need to be established.~      Therefore, the investigators aim to do a single center prospective randomized controlled~     clinical trial to assess the effect of supratotal resection at least 1 cm beyond the MR~     imaging-defined abnormalities on progression-free survival (PFS) of glioma.~   "
29066|NCT02676674|"~     This is a pre-post open label trial to assess the change in Vitamin D blood levels following~     treatment with three doses of topical Vitamin D3 in 20 subjects with existing Vitamin D~     deficiency.~   "
29067|NCT02676661|"~     To investigate the prevalence and risk factors for peri-implant disease in partially~     edentulous patients rehabilitated with implants supported crown or bridge so as to provide~     evidence for clinical prevention and control.~   "
29068|NCT02676648|"~     The goal of the research is to optimize an online and mobile multicomponent 12-month diet~     and lifestyle intervention for improving the blood glucose control of individuals with type~     2 diabetes.~   "
29069|NCT02676635|"~     Masons have the highest rate of overexertion injuries among all construction trades and rank~     second as an occupation for back injuries in the United States. Identified ergonomic~     solutions are the primary method of reducing exposure to risk factors associated with~     musculoskeletal disorders. However, many construction workers lack knowledge about these~     solutions, as well as basic ergonomic principles. Construction apprentices, as they embark~     on their careers, are greatly in need of ergonomics training to minimize the cumulative~     exposure that leads to musculoskeletal disorders. Apprentices receive safety training;~     however, ergonomics training is often limited or non-existent. In addition, apprenticeship~     programs often lack soft skills training on how to appropriately respond to work~     environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics -~     strives to integrate evidence-based health and safety training strategies into the mason~     apprenticeship skills training to teach ergonomics, problem solving, and speaking up to~     communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is~     that the combination of ergonomics training and safety voice promotion will be more~     effective than no training or either ergonomics training alone or safety voice training~     alone.~      Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated~     in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S.~     Clusters of apprentices within centers will be assigned at random to one of three~     intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined~     ergonomics and safety voice training, or (3) control group with no additional training~     intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six~     and 12 months post training will include: musculoskeletal symptoms, general health~     perceptions, knowledge of ergonomic and safety voice principles, and perception and~     attitudes about ergonomic and safety voice issues.~   "
29070|NCT02676622|"~     Crohn's disease is an 'auto-immune' disorder of the gut. In this condition the body's own~     immune system is fighting its gut and causing inflammation and other symptoms. Patients who~     are refractory (not responding) to the medications usually used to control Crohn's disease~     (medicines like steroids, azathioprine, methotrexate, cyclophosphamide and antibodies like~     Infliximab), may consider being part of this study.~      In this study, the investigators plan to wipe out (ablate) the 'faulty immune system' with~     medicines (immune-ablation) and then give back the patients own stored stem cells (that have~     been collected before) - a procedure called autologous (self) stem cell transplant (ASCT).~     Once the new immune system regrows again from the stem cells, it is hoped that the 'faulty'~     immune cells do not return again and do not fight the gut leading to remission from symptoms~     of Crohn's disease. The aim of this treatment therefore, is to reset or re-program the~     immune system, so that it does not fight the patient's own body.~      Currently, there are very few trials and experience with this procedure in children and~     young adults. There have been a few studies that have shown benefit of ASCT procedure in~     adult patients. In some patients, the benefit lasted for 1-5 years; but 1 in 5 (20%)~     participants were not taking their medications for the Crohn's disease even 5 years after~     ASCT. Other 80% needed medications again, but in most cases with better disease control.~      In order to potentially improve the long term outcomes of ASCT, the investigators are adding~     another medication (in addition to those used in adult studies) called IL-2 (Aldesleukin),~     which will be given as an every-other-day injection under the skin (subcutaneous) at very~     low doses for 6 weeks after the ASCT and can be taken at home. Low dose IL-2 is known to~     increase a type of immune cell called T-regulatory cells (Tregs) that make immune cells less~     reactive to self. Study doctors believe that increased population of Tregs after ASCT may~     lead to a better control of Crohn's disease- higher percentage of cures or disease control~     for a longer period of time compared to the previous adult trials.~      Therefore, the goals of this study are-~        1. To see if ASCT can be used safely and can provide substantial benefit in young adults~          who have refractory Crohn's disease.~        2. To see if addition of IL-2 after the ASCT is safe and effective.~   "
29071|NCT02676609|"~     During this study, we will assess a new smart phone application which aims at helping~     patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses.~     Patients, already trained to carbohydrate counting, will be recruited among those who have~     been using this method daily for at least 6 months. They will complete two one-month study~     phases, using the application in one phase and counting carbohydrate and insulin doses~     without the application in the other phase, with randomized order of each phase. Visits are~     scheduled at the start and at the end of each phase to collect data on glucose control and~     insulin doses. Questionnaires assessing health-related quality of life and ability of~     self-management of diabetes will also be filled by patients before and after each study~     phase.~   "
29072|NCT02676596|"~     The purpose of this study is to investigate the safety tolerability, and PK profile of K-312~     and its metabolites in healthy Japanese and non-Japanese adults.~   "
29121|NCT02675959|"~     This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and~     toxicity of administering Defibrotide prophylaxis for high-risk sickle cell patients~     undergoing a familial haploidentical allogeneic stem cell transplantation with CD34~     enrichment and T-cell addback. This patient population historically has a risk of developing~     sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment~     of SOS.~   "
29122|NCT02675946|"~     This is a multicenter, open-label, repeat-dose, Phase 1 study consisting of a Dose~     Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and~     clinical activity.~   "
29073|NCT02676583|"~     Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An~     inexpensive method and with few evidence in the literature on effectiveness in reducing pain~     is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators~     will compare the pain after tonsillectomy between closure or not the tonsil fossa.~      Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred~     otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated~     tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be~     enrolled from November 2015 to July 2016. The procedure will be performed by a single~     surgeon and similar postoperative medications will be prescribed. There will be two~     techniques: closure or not of the tonsillar fossa with catgut points. A questionnaire~     containing a Faces Pain Scale - filled 1 and 7 days after surgery- and other data -~     difficulty of detachment of the palatine tonsils, hemostasis technique, surgical~     complications, healing characteristics, day of total improvement of the pain, day of~     beginning of normal food intake, presence of postoperative bleeding, complications and~     observations raised by the patient - will be applied.~   "
29074|NCT02676570|"~     1. Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to~          distinguish and compare Aspergillus species to the existing optical pathological~          diagnosis.~        2. PCR(polymerase chain reaction) validation.~        3. Compare PCR results, microbial results and treatment results with the medical record.~   "
29075|NCT02676557|"~     The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the~     change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study.~     In the present study, the investigators intended to investigate whether the changes of the~     deep and superficial structures around ONH exist or not using EDI OCT.~   "
29076|NCT02676544|"~     This is a prospective, open label single center feasibility study to demonstrate basic~     safety and effectiveness of prostate artery embolization for the treatment of symptomatic~     benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams)~     glands.~   "
29077|NCT02676531|"~     This study is to evaluate the effects of Walking Meditation on vascular function in breast~     cancer patients receiving Anthracyclines chemotherapy~   "
29078|NCT02676518|"~     Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose~     intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)~   "
29079|NCT02676505|"~     The primary purpose of this study is to compare the effects of two different methods of care~     during the second stage of labor for nulliparous women (coached versus uncoached pushing) on~     the length of the second stage and how this may affect maternal and neonatal outcome.~   "
29080|NCT02676492|"~     This study will explore the relationship between sleep, learning, cognition, mood and~     behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder)~     compared to typically developing peers.~   "
29081|NCT02676479|"~     The study will involve up to 30 pairs of male and female sexually intimate partners who are~     carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of~     transmitting the gene. The female partner will be superovulated to mature multiple oocytes~     which can be fertilized, inseminated with her partner's sperm through intra-uterine~     insemination (IUI). Four to six days after IUI, the female partner will undergo a~     non-surgical uterine lavage procedure to recover preimplantation embryos.~   "
29082|NCT02676466|"~     ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing~     major mobility disability by improving or preserving walking ability.~   "
29083|NCT02676453|"~     Objective: The aim of this study was to evaluate the effects of dental hygienist support on~     oral health and attitudes to oral healthcare in nursing homes for older people.~      Background: Studies in long-term care facilities have indicated that oral health is often~     unsatisfactory. It is important that nursing staff are able to assist dependent care~     recipients. Dental hygienist support has been suggested as valuable help.~      Material and methods: Two nursing homes were randomly selected for intervention and control.~     Interventions included weekly support from dental hygienists on oral hygiene procedures,~     prescriptions for individual oral hygiene procedures, and oral care organisational issues.~     The residents' oral health, measured by dental plaque levels, gingival bleeding and the~     Revised Oral Assessment Guide (ROAG), was evaluated before and after three months. Attitudes~     among the staff to oral healthcare were collected through a questionnaire.~   "
29084|NCT02676440|"~     This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy~     female and male participants aged over 18 years will participate. There will be two groups~     of up to 120 participants. Participants will be randomised to the test groups according the~     allocation table prepared by the Statistician.~      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.~     After enrollment participants will have their teeth that have been allocated for assessment~     cleaned using a professional prophylaxis polish by the study dentist. The participants will~     then be provided with a standard cosmetic silica Fluoride toothpaste and a toothbrush to use~     at home, twice a day for up to four weeks. After this time they will return to the test site~     and have the baseline dental assessments. Participants will then be randomly allocated to~     one of the two test products which they will use at home, twice a day for the duration of~     the study. Dental assessments will be conducted after 13 and 26 weeks of product use at the~     study site.~   "
29085|NCT02676427|"~     The study aims at clarification of venous collapsibility measures with real venous flow~     measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.~   "
29086|NCT02676414|"~     The primary purpose of this study is to assess the effect of participating in the~     interactive hypertension education program of the German Hypertension League (DHL©) My~     blood pressure - OK! on office systolic blood pressure.~   "
29087|NCT02676401|"~     This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer~     term, following MT-3995-J05 study.~   "
29088|NCT02676388|"~     The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh~     FMT in adults with slow transit constipation.~   "
30542|NCT02657330|"~     This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects~     with previously treated pancreatic ductal adenocarcinoma and will identify the maximum~     tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK)~     profile and preliminary efficacy of SBP-101.~   "
29089|NCT02676375|"~     The study investigators will enroll 45 treatment seeking, cigarette smokers with a~     Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly~     assigned into three arms of treatment for smoking cessation treatment, receiving either 1.~     Control: standard therapy (n=15), including stepwise monotherapy of nicotine patch or~     bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine~     patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination~     bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and~     phone calls to the home or living facility. During all treatments, participants will receive~     weekly smoking cessation group counseling, as is standard for smoking cessation treatment.~     At the time of enrollment, participants will complete a one-study visit lead-in to complete~     baseline assessments, psychological and medical evaluation, and comprehensive assessment of~     drug use to determine study eligibility. Once determined to be eligible for the trial,~     participants will be randomly assigned to one of the treatment arms using a randomization~     procedure. The standard therapy treatment arm, or control group, will receive either~     nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed,~     and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a~     total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with~     as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained~     release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg~     twice daily for 6 months (as tolerated). The third arm will be identical to the second arm~     except for the added home visit intervention.~   "
29090|NCT02676362|"~     The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF)~     and its flow into and from periodontal pockets are not understood very well. The aim of this~     study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil~     elastase (NE) enzyme activity by using intracrevicular and orifice methods.~   "
29091|NCT02676349|"~     This is a prospective, randomized phase II trial. The aim of this study is to assess the~     efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic~     cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or~     without preoperative chemoradiotherapy with capecitabine.~   "
29092|NCT02676336|"~     This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the~     safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast~     health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of~     effectiveness.~   "
29093|NCT02676323|"~     Cancer is the uncontrolled growth of human cells. The growth of normal human cells is~     controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs~     called histone deacetylase (HDAC) inhibitors. HDAC inhibitors like panobinostat block~     enzymes known as histone deacetylases, which stops cancer cells from dividing and causes~     them to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to~     treat pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS).~      The purpose of this study is to test the safety of panobinostat and to find the highest dose~     of panobinostat that can be given safely when it is combined with fludarabine and~     cytarabine.~      This pilot study will be done in two parts: The goal of Part 1 of the study is to find the~     highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when~     it is combined with fludarabine and cytarabine. Once that dose is determined, participants~     will be enrolled on Part 2: Dose Expansion, to look at the effect of the~     panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.~      PRIMARY OBJECTIVE:~        -  Determine a tolerable dose of panobinostat when given in combination with fludarabine~          and cytarabine in pediatric patients with relapsed or refractory AML or MDS.~      SECONDARY OBJECTIVES:~        -  Characterize the pharmacokinetics of panobinostat after the first dose and at~          steady-state.~        -  Estimate the overall response rate to the combination of panobinostat, fludarabine, and~          cytarabine.~   "
29094|NCT02676310|"~     This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients~     with androgenetic alopecia (AGA).~   "
29095|NCT02676297|"~     The purpose of this study is to compare the absorption of two different inhalation products~     with the reference product in healthy volunteers.~   "
29096|NCT02676284|"~     This was a prospective, open, non-comparative study in 36 subjects with rhizarthrosis~     comparing signs and symptoms before and after a single injection of DUROLANE SJ in the~     affected hand. Subjects were assessed pre-treatment and at 1, 3, and 6 months~     post-treatment.~   "
29097|NCT02676271|"~     Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments~     for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose~     was to determine the long term clinical and radiographic outcomes of these patients.~      Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long~     term follow-up study a decade ago were approached for the present study.~      All patients were treated in our institution during 1959 to 1983 with proximal VDRO.~      The patients were invited to for a medical interview and a physical examination. They were~     also asked to fill out questionnaires and to provide or undergo a standing anteroposterior~     (AP) pelvic and a lateral hip radiographs during the visit.~      Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to~     grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding~     daily function, physical activity, work status and family history were obtained. All~     participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short~     Form-36 which is composed of 8 sections and has a maximum score of 100.~      The physical examination included an assessment of the hip range of motion, leg length~     discrepancy and the presence of a Trendelenburg sign.~      Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head~     size ratio, and the center-edge (CE) angle.~   "
29098|NCT02676258|"~     The objective of this study is to evaluate a new daily disposable silicone hydrogel soft~     contact lens by comparing to an existing daily disposable soft contact lens.~   "
29099|NCT02676245|"~     To address the content, timing, efficacy, and impact of prenatal education about newborn~     screening generally and sample retention specifically.~   "
30589|NCT02656719|"~     Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy~     and bronchoscopy guided percutaneous tracheostomy.~   "
29100|NCT02676232|"~     Chronic and recurrent pain is a very important issue in the society, and its treatment is~     challenging.~      In children, one of the most common pain problems is recurrent abdominal pain. This problem~     can affect up to 12% of the children population, and can interfere on daily activities of~     both children and parents. Recurrent abdominal pain in children is also associated with~     other health problems, and can be related to problems in adulthood. Unfortunately, the~     current health system does not have an effective treatment for these children and their~     families. This is why the investigators propose an online intervention, DARWeb, for people~     in this situation.~      DARWeb provides an innovative solution using Information and Communication Technology to~     facilitate access. It is also innovative because it is directed towards secondary~     prevention, in contrast to the majority of current treatments available for pain problems~     that are focused in reducing the impact of pain when it is already severe. Thus, the~     objective of DARWeb is to provide information and teach strategies to children and their~     parents that help them to cope with pain and prevent pain interference in their daily lives~     (in the short, medium and long term).~      With this project, the investigators plan, first, to create a new version of their treatment~     program (DARWeb V2) from the results of the pilot study. Second, the investigators will test~     the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they~     will assess the short, medium and long term effects. In addition, the investigators want to~     study which of the variables that are addressed in their intervention are responsible for~     the potential changes observed.~      The investigators expect that their treatment program will be effective to reduce pain in~     the short, medium and long term.~   "
29101|NCT02676219|"~     The study design is a randomised, split mouth, blind with respect to study analysts~     (microscopist, image grader) two treatment clinical study in 10 healthy participants with~     sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5~     subsequent clinic visits. At the screening visit, participants will give consent to~     participate in the study. Medical history and concomitant medications will be recorded.~     Eligibility will be determined following an oral soft tissue (OST) examination and an~     evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study~     assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will~     be collected from the participants at set points during the study to look at any changes in~     salivary pH.~   "
29102|NCT02676206|"~     The investigators propose to determine whether listening to classical music during a~     sedation procedure decreases the need for procedural sedation medication. It is a two arm~     study comparing music vs no music by headphones so that the investigator is blinded to the~     intervention. The outcome variable is amount of sedative used and self-reported anxiety~     level as reported on a 10 point visual analogue scale (VAS). The music intervention is begun~     1 minute prior to the sedation procedure and continued until the subject is completely~     awake. Demographics will be collected for all patients. No identifiers are collected. Data~     will be compared for a change in VAS variable using non parametric methods.~   "
29103|NCT02676193|"~     The investigators are addressing two critical areas identified by the FDA: the impact of~     cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the~     effectiveness of graphic warning labels on communicating risk of tobacco products. In a~     randomized controlled trial (RCT), investigators will enroll committed smokers who have no~     intention of quitting in the next 6-months. The three study arms will be: a) a plain pack~     with all marketing materials removed (PP); b) The Australian graphic warning images~     (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST).~     The study includes a three month purchasing intervention and continued follow-up through 12~     months. Throughout the study interactive text messaging assessments will be used to measure~     acute and persistent impact of labeling and marketing on perceptions of tobacco products,~     subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior,~     and quitting motivation. At three separate time points, participants will: a) complete a~     web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous~     design and extensive objective measurements are significant innovations on the currently~     published research in this field and should lead to significant advances in tobacco~     regulatory science.~   "
29104|NCT02676180|"~     DETECT I is a prospective multicentre observational diagnostic study to assess the~     performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The~     study will recruit consecutive patients attending haematuria clinics as well as patients~     referred to urology outpatient clinics for investigation of haematuria. Consenting patients~     will be provided with a urine sample collection kit and asked to provide a urine sample. An~     additional urine sample for control assay testing will be provided after the clinic~     attendance.~   "
29105|NCT02676167|"~     This developmental research grant award (R21) requests funds to explore the feasibility and~     impact of a public health system PrEP intervention in a recently emerging HIV epidemic in~     Athens Greece. The investigators propose a modeling approach using an Agent Based Model~     (ABM) that moves beyond basic pathogen and transmission patterns to dealing with complex~     social interactions, including overlapping social and sexual networks as well as~     implementation realities, like finite PrEP resources, delayed linkage to PrEP care and early~     PreP care retention based upon empirically collected data in Athens Greece.~   "
29106|NCT02676154|"~     This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD)~     in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect~     of increasing daily use of fesoterodine on episodes of high blood pressure triggered by~     urinary bladder contractions.~   "
29107|NCT02676141|"~     This study evaluates if the German Version of the NDI is sensitive to change over time.~   "
29108|NCT02676128|"~     Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression~     and consequently lead to negative health consequences. This study aims to refine and test~     the efficacy of a mobile health ART adherence application (ARTAA), delivered over a~     smartphone, with helping individuals improve their ART adherence.~   "
29109|NCT02676115|"~     This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic,~     effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate~     ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve~     cosmetic wound healing and scaring.~   "
29123|NCT02675933|"~     This study is a randomized controlled trial utilizing a patient-centered questionnaire~     distributed to parents of children with autism. The study arm will receive the questionnaire~     and will be compared to the control arm, which will receive standard of care. The results of~     satisfaction surveys will be the primary endpoint of this study.~   "
29124|NCT02675920|"~     The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of~     bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk~     of HCC.~   "
29125|NCT02675907|"~     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in~     subjects with acute moderate to severe pain following unilateral bunionectomy.~   "
29110|NCT02676102|"~     The primary purpose of this 3-phase mixed methods design study is to investigate how~     presenting content at varying levels of audience specificity (generic, targeted, and~     tailored) influences organ donor registration behavior among black men using video-based~     educational programming produced and distributed in partnership with our network of Black~     Owned Barbershops (BOBs). Investigators have completed a development phase using digital~     video interviewing to both derive and provide culturally specific content for the videos.~     This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which~     customers will be randomized to receive the generic, targeted, or tailored video programming~     delivered with iPads, after which an immediate organ donation opportunity will be offered~     through registration online or with a mailed in application. The final phase of this~     investigation will be a failure analysis whereby we will interview a subset of participants~     who registered or failed to register one month after their educational session to ascertain~     how the programming impacted their decision (Aim 3 - the subject of a future IRB~     application).~   "
29111|NCT02676089|"~     The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI~     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus~     glycopyrronum bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine~     beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993~     200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of~     lung functions parameters and rate of exacerbations, as well as to assess its safety and~     some health economics outcomes.~   "
29112|NCT02676076|"~     The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI~     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus~     glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine~     beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters~     and rate of exacerbations, as well as to assess its safety and some health economics~     outcomes.~   "
29113|NCT02676063|"~     The primary objective is to evaluate neonatal characteristics, and biological and clinical~     investigations as predictive factors of death, or of severe and moderate neurodevelopmental~     disability at 3 years, in a large population-based cohort of full-term and late preterm~     neonates with moderate or severe HIE.~      Contrary to most previous studies which have often analyzed the accuracy of one factor among~     all other clinical investigations, the investigators objective's is to seek a relevant~     combination of several factors among the following list:~        -  Neonatal characteristics: gestational age and birthweight, maternal disease, acute~          intrapartum event, delivery mode, acidosis, neurological examination, place of birth~          and neonatal transfer~        -  Laboratory investigations: pH, lactates and new biological markers as detailed below~        -  Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI~   "
29114|NCT02676050|"~     Lung cancer is currently a major health problem in the UK. Despite being one of the most~     common cancers, lung cancer has a poor prognosis compared to other types of cancer and is~     the leading cause of cancer death in the world. As opposed to other organs, the lung is~     highly susceptible to inflammatory insults, for example from bacterial infection-induced and~     tobacco-induced inflammation. It has long been known that the cellular microenvironment that~     nurtures tumour growth and development is linked to sites of chronic inflammation but~     molecular insights into how external inflammation boosts or inhibits cancer in the lungs~     remains unclear. This study aims to directly visualise the expression of a well known marker~     of cancerous tissue, c-MET, and the activity of neutrophils in human lung cancer in vivo in~     situ using fibre-based endomicroscopy.~   "
29115|NCT02676037|"~     Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The~     current diagnostic tool is using X-ray which is expensive and includes radiation exposure.~     The current study is aimed at using the foot pressure platform as an alternative method for~     diagnosis and evaluation of the deformity. The main subjects will be recruited from~     orthopaedic outpatient clinics.~      The recruited subjects will undergo the non-invasive and radiation free study by walking on~     a pressure platform. Then their pressure data will be correlated with their radiological~     study which has already been done in the clinic. The aimed outcome of the study is use the~     foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus~     deformity.~   "
29116|NCT02676024|"~     In-hospital pediatric cardiac arrest is an important public health problem affecting almost~     6000 children a year in the United States. As many as 3% of patients admitted to a~     children's hospital require cardiopulmonary resuscitation (CPR). Only a minority of children~     survive, of which around 35% go on to have a poor neurological outcome. International~     consensus guidelines on science and treatment recommendations for the management of~     pediatric resuscitation have existed for decades and are revised periodically by the~     International Liaison Committee on Resuscitation (ILCOR) based on available evidence. This~     consensus is then used by national councils such as the American Heart Association (AHA) and~     the Heart and Stroke Foundation of Canada (HSFC) to make guidelines for care. These~     guidelines focus on a structured approach to resuscitation, which emphasizes the rapid~     implementation of key interventions such as starting chest compressions, administering~     epinephrine and defibrillation. The goal of this study is to improve outcomes after cardiac~     arrest in children by improving adherence to consensus guidelines. The investigators aim to~     achieve this by conducting a multi-center, prospective, factorial randomized study with~     participating sites from the International Network for Simulation-based Pediatric~     Innovation, Research and Education (INSPIRE).~      The specific aims of this study are to:~        1. To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric~          Advanced Life Support (PALS) algorithm cards, in healthcare teams.~        2. To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive~          Aids with Roles Defined (CARD) system, in healthcare teams.~        3. To determine if there is a synergistic effect when adding the CARD system to the use of~          knowledge-based cognitive aids or indeed whether using both these tools together has~          unintended consequences and reduces the added value of each technique.~        4. A secondary aim is to identify whether additional simulation-based team training in the~          use of cognitive aids results in a significant improvement in performance over an~          e-learning module.~      The investigators hypothesize that (i) knowledge-based cognitive aids will significantly~     improve the performance of healthcare teams in providing PALS in a simulated setting, (ii)~     that teamwork-based cognitive aids (CARD) will significantly improve the performance of~     healthcare teams in providing PALS in a simulated setting, and that (iii) adding the CARD~     system to knowledge-based aids will have an added and synergistic effect, (iv) that the team~     performance in all study arms will improve after simulation based training, but that that~     the groups with cognitive aids will continue to out-perform the groups without cognitive~     aids.~   "
29117|NCT02676011|"~     Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The~     aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad~     arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.~   "
29118|NCT02675998|"~     This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a~     4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety~     and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients~     on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either~     receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.~   "
29127|NCT02675881|"~     Increasing ablative zone is an essential part to improve technical success and long term~     outcome in patient treated with radiofrequency ablation (RFA).~      A combination of dual switching system and separable clustered electrode has been reported~     to create large ablative zone in preclinical study.~      Based on preclinical study, the investigators conducted a preliminary study in eligible 60~     patients to measure whether this combination (dual switching system and separable clustered~     electrode) improves technical success rate and local tumor progression rate over a year, in~     comparison with historical control group.~   "
29128|NCT02675868|"~     Noradrenaline is a catecholamine and the cornerstone treatment for the improvement of~     hemodynamic parameters in septic shock. Catecholamines exert profound immunomodulatory~     effects. Noradrenaline in vitro inhibits LPS-induced pro-inflammatory cytokine production,~     however, the actions on immune function in vivo have not been assessed. Furthermore, effects~     on the immune system of viable vasopressor alternatives for the treatment of septic~     patients, namely phenylephrine and vasopressin, need to be established in humans in vivo.~   "
29129|NCT02675855|"~     The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration~     to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.~   "
29130|NCT02675842|"~     Radiation therapy to the chest is used in late stage lung cancer, and it often leads to~     inflammation of the esophagus. The inflammation is expected to occur in about 75% of~     patient, and usually begin within a week of starting radiation therapy. The esophagitis~     causes pain and difficulty eating. It can also result in stopping or delaying~     treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often~     leads to inflammation of the esophagus. The inflammation is expected to occur in about 75%~     of patient, and usually begin within a week of starting radiation therapy. The esophagitis~     causes pain and difficulty eating. The endocannabinoid system is prominent in the~     gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The~     compound (−)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation~     and pain. Cannabidiol is a component of cannabis that does not produce subjective or~     intoxicating effects, but also has prominent anti-inflammatory properties.~      The goal of this study is to perform a double-blind, placebo-controlled study to investigate~     the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation~     Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used~     , which is a cannabinoid that does not change perception or produce intoxication, and low in~     Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the~     possible side effects of cannabis in medically ill participants.~   "
29131|NCT02675829|"~     The purpose of this study is to find out what effects, a drug called ado-trastuzumab~     emtansine has on the patient and their cancer which is thought to be controlled by the~     abnormal HER2 gene.~   "
29132|NCT02675816|"~     The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper~     Airway System (UAS) in a commercial setting. This study will provide additional clinical~     evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA)~     using a randomized controlled trial design.~   "
29133|NCT02675803|"~     This study will investigate the safety and tolerability of VAY736 administered as single~     ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous~     injections in rheumatoid arthritis patients.~   "
29134|NCT02675790|"~     The overall goal of the proposed study is to determine the effectiveness of hydroxyurea~     therapy for secondary stroke prevention and prevention of other neurological events in~     children with SCA with an acute overt stroke.~   "
29135|NCT02675777|"~     Alcohol use is the third greatest cause of disability and death for US adults. Care for~     unhealthy alcohol use is lacking in most primary care settings. This project will implement~     two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a~     regional health system—Group Health (GH). These include preventive care and treatment.~     Preventive care consists of alcohol screening, and for patients who screen positive, brief~     patient-centered counseling. Treatment for alcohol use disorders includes offering shared~     decision making and motivational counseling designed to enhance engagement in one or more~     treatment options: counseling, medications, and/or specialty treatment. During a pilot~     phase, the research team at Group Health Research Institute partnered with Group Health~     leaders and front line clinicians to design, pilot test, and iteratively refine an~     implementation strategy in 3 Group Health primary care clinics.~      Objective~      This study uses state-of-the-art implementation strategies to integrate evidence-based~     alcohol-related care into 22 primary care clinics (detailed below). This study is a~     pragmatic stepped-wedge quality improvement trial to evaluate its impact on:~        1. The proportion of patients who have primary care visits who screen positive for~          unhealthy alcohol use and have documented annual brief alcohol counseling;~        2. The proportion of patients who have primary care visits who have AUDs identified, and~          a) initiate and b) engage in care for AUDs.~      Secondary outcomes will include:~        1. The proportion of patients who have primary care visits who have documented annual~          alcohol screening with the AUDIT-C; and~        2. The proportion of patients who have primary care visits who screen positive for severe~          unhealthy alcohol use and have AUDs assessed and/or diagnosed;~   "
29136|NCT02675764|"~     The objective of this pilot project is to assess the impact of the novel sensory stimulation~     technique the investigators have developed in enhancing outcomes of hand therapy as well as~     the central nervous system responsiveness in chronic stroke survivors.~   "
29137|NCT02675751|"~     Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.~   "
29138|NCT02675738|"~     Prospective, observational, cohort study to evaluate the reliability of preoperative work-up~     of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral~     center. A comparison between the preoperative diagnostic suspicion and the final pathologic~     report will be done.~   "
29139|NCT02675725|"~     Fluid therapy is one of the cornerstones of the treatment of organ failure. The~     investigators assume that fluid bolus will increase the delivery of oxygen to the cells and~     resolve the shock.~      The purpose of this study is to asses kinetics of the sublingual microcirculation in one~     place during a fluid bolus. It is expected that fluid therapy after normalization of the red~     blood cell flow velocity in the microcirculation will result in a decrease in capillary~     density through the formation of edema in the tissues. This can be considered to be the~     tipping of potentially beneficial to deleterious effects of fluid therapy.~      After cardiac surgery patient will be transferred to the ICU for further stabilisation.~     Within specific indications the patient will receive a fluid bolus, these indications are~     hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus~     will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual~     microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary~     vessel density on one spot during this fluid bolus.~   "
43253|NCT02490852|"~     This is a growth study of full-term infants. The growth of infants fed the investigational~     formula will be compared with infants fed a control formula. A breastfeeding arm will be~     used as reference.~   "
29142|NCT02675686|"~     The discovery of antenatal bilateral renal anomaly poses an essential question: can we~     predict postnatal renal function in short, medium and long term? Ultrasound appears~     sufficient in severe or mild forms. In the Intermediaries form (normal size dysplastic~     kidneys with persistence of amniotic fluid), ultrasound and current markers do not predict~     postnatal renal function evolution.~      The objective of this study is to estimate the specificity and sensitivity of amniotic~     biomarkers profile in the diagnosis of renal functionality in fetuses with bilateral~     nephropathy development.~   "
29143|NCT02675673|"~     The purpose of this study is to compare the quality of life (QOL) in head and neck patients~     who are given the GJ tube (which is placed in the bowel) versus those who are given the~     G-Tube (which is placed in the stomach) for prophylactic feeding. The standard of care for~     patients at Princess Margaret Hospital (PMH) is using GJ tubes. Patients who agree to be in~     the study will be randomized to either the GJ-Tube or the G-Tube arm. Patients randomized to~     the G-tube will receive prophylactic intravenous and oral antibiotics prior to insertion of~     the G-tube. Antibiotics will be given for a total of 1 week. A few hours following tube~     insertion (on return to PMH ward), patients will complete a single item, visual analogue~     pain scale (VAS). Patients will remain in hospital for a minimum of 24 hours and until the~     patient and/or family is able to care for the Enteric Feeding(EF) device at home. Patients~     randomized to the GJ-Tube may receive i.v medication during the procedure. All Patients will~     be asked to fill out several questionnaires at different time- points of the study. All~     Patients will have regular assessments to evaluate their overall quality of Life, toxicity,~     and how they respond to treatment during the study. Patients will also be assessed after~     they completed study treatment.~   "
29144|NCT02675660|"~     This study represents an initial clinical evaluation of an oral formulation of~     L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are~     both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter~     nutraceutical. This study will provide information on the dosing of L-homoarginine in order~     to reach high physiological plasma concentrations in humans.~   "
29145|NCT02675647|"~     The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well~     established in obese patients.~      Results of a preview study show that the standard heparin management based on total body~     weight in obese patients during CPB resulted in excessive heparin level, which could lead to~     excessive postoperative bleeding.~      To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese~     patients was proposed.~      The main objective of the study is to evaluate the effects of heparin injection, based on~     ideal body weight, on intraoperative plasma heparin levels and activated coagulation time~     (ACT) in a population of obese patients, compared to a group of obese patients undergoing~     CPB surgery with heparin management based of total body weight.~      The secondary objectives are to evaluate the relationship between heparin level and ACT in~     each group of patients and at different time points during CPB, and to compare the incidence~     of bleeding, intraoperative transfusions and complications in the two groups of patients.~   "
29146|NCT02675634|"~     This clinical investigation is intended to explore the performance and safety of two newly~     developed ostomy products with regard to the products fit to body properties.~   "
29147|NCT02675621|"~     An acute, randomized, placebo controlled, double blinded crossover study in health subjects.~     Participants will complete 4 intervention arms in random order consisting of a placebo~     control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with~     a fruit extract, and a low does phenolic beverage. The primary objective of the study is to~     assess the effects of the phenolic compounds, at two different levels, alone and in~     combination with a fruit extract, on mood and cognitive performance during extended periods~     of cognitively demanding task performance.~   "
29148|NCT02675608|"~     This study evaluates the effectiveness of the seasonal flu vaccine in adults of different~     ages and diabetic disease statuses. These studies will help our understanding of how chronic~     inflammatory diseases impact immunologic function and future research on mitigation~     strategies.~   "
29149|NCT02675595|"~     Hypothesis:~      In Women in the second trimester of pregnancy 5D offers an alternative method for fetal~     Echocardiography compared to conventional 2D scanning~      Question:~      Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of~     second trimesteric fetuses?~      Aim:~      This study aims at assessing the accuracy of performance of the 5D as a new scanning~     technology in fetal Echocardiography compared to the conventional use of 2D scanning.~   "
29150|NCT02675582|"~     The primary objectives of this study are to assess the effects of three investigational~     drinks containing three botanicals in differing combinations versus a placebo control, on~     mood, psychological state, physical response, and cognitive performance during and after~     exposure to an observed multi-tasking stressor.~   "
29151|NCT02675569|"~     This pilot randomized controlled trial (RCT) is multi-center, parallel-arm, and open label.~     It will test the feasibility and safety of randomizing elderly patients with end-stage~     kidney failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the~     following vascular access strategies: (a) attempt at fistula creation (intervention), or (b)~     continued use of a catheter (comparator). A total number of 100 participants will be~     enrolled in this pilot RCT. The rationale for this trial includes: (1) the importance of the~     intervention question related to the choice of vascular access for patients treated with~     hemodialysis; (2) lack of evidence from clinical trials for decision-making in this area~     (only observational studies are available); (3) existing studies which suggest that fistula~     use is associated with better patient outcomes are very prone to selection bias; (4) need~     for a clinical trial comparing the impact of the two most frequently chosen strategies for~     vascular access (catheter and fistula) in the hemodialysis population; and (5) a feasible~     and safe trial design. The results obtained from this pilot RCT will determine the~     feasibility and safety of conducting a large RCT, which will be powered for the primary~     outcome of all-cause mortality.~   "
29152|NCT02675556|"~     This study is intended to evaluate the safety and potential efficacy of Allogeneic Human~     Mesenchymal Stem Cell Infusion versus placebo in patients with Treatment Resistant~     Depression.~   "
31156|NCT02649283|"~     This is a Phase IV, multicenter, open label, non-randomized comparative group study to~     assess the safety and performance of the OrbiSymm system in subjects referred to contra~     lateral breast symmetrization involving a breast reduction following breast reconstruction~     post-mastectomy.~   "
29153|NCT02675543|"~     The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery~     has its apex in the development of PVR that occurs when retinal cells are exposed to the~     inflammatory milieu in the humor vitreous.~      This situation is common in complicated retinal detachment, but is amplified after invasive~     surgery and by the use of intraocular tamponades that float over a subtle film of liquid~     where the inflammatory cytokines and growth factors reach the critical concentration over~     the inferior retina.~      Many authors have noted that the heavy tamponade are more prone to cause intraocular~     inflammation compared to standard silicone oil, especially if they remain for several months~     in the eye.~      The purpose of this study is to measure the vitreous concentration of some of the most~     important cytokines involved in the inflammatory vitreal response.~   "
29154|NCT02675530|"~     This study investigates the common features of electrophysiological measures in~     schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.~   "
29155|NCT02675517|"~     The primary objective of the study is to measure changes in physical functioning - serving~     as a surrogate for physical activity and exercise capacity - in COPD patients being treated~     with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate~     the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the~     start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks~     after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.~   "
29156|NCT02675504|"~     Since the 2000s, the experiences of children and especially their fear during a~     consultation, a treatment or examination is food for thought in our establishment. There is~     no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us~     to create this tool. The scale self-assessment of the fear that we have developed consists~     of six faces representing a gradual level of fear: the child can easily describe their level~     of fear, which allows for appropriate care.~   "
29157|NCT02675491|"~     This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of~     DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1~     or NTRK fusion gene.~   "
29158|NCT02675478|"~     This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics~     of quizartinib for Japanese acute myeloid leukemia (AML) subjects.~   "
29159|NCT02675465|"~     This study is an international, multi-center, study of Pompe disease patients that are~     currently receiving enzyme-replacement therapy (ERT). The purpose of this study is to find~     out if the co-administration of investigational new drugs ATB200 and AT2221 is safe in~     adults with Pompe disease.~   "
29160|NCT02675452|"~     At least one dose level of AMG 176 will achieve acceptable safety and tolerability in~     subjects with relapsed or refractory multiple myeloma~   "
29161|NCT02675439|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,~     pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral~     injection.~   "
29162|NCT02675426|"~     This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in~     subjects with moderately to severely active rheumatoid arthritis on a stable dose of~     csDMARDs who have had an inadequate response to csDMARDs.~   "
29163|NCT02675413|"~     This is a prospective study that will explore the mechanisms of efficacy of dimethyl~     fumarate (DMF) treatment in multiple sclerosis (MS). Investigators will enroll relapsing MS~     patients who are beginning therapy with DMF into a one-year longitudinal study in which~     blood and spinal fluid analyses, imaging and clinical studies will be performed to identify~     and measure changes associated with DMF therapy.~   "
29164|NCT02675400|"~     In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of~     paternal ADHD in families and children with ADHD symptoms has not been studied, despite the~     prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on~     treatment on the family and child, and effects of treating fathers relative to mothers with~     ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.~      The investigators hypothesize that successfully treating parental ADHD in fathers will have~     a beneficial effects on the family that will extend to the child. Specifically, the~     investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD~     medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and~     improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral~     Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who~     have children between the ages of 3 -8.~      As in the investigator's previous work, the investigators will bank paternal and child DNA~     and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of~     stimulant response.~   "
29165|NCT02675387|"~     Children in their seventh year of life (age range of 6 to 7 years) will be included in the~     study. All children included in the study would have to classified according to the Wright~     behavior classification as potentially co-operative and rated as per the Frankl behavior~     rating scale as positive (++) Group A and negative (-) Group B . All children included must~     have had no prior experience of dental anesthesia and must have at least one tooth requiring~     restorative procedure on either side of the maxillary arch. Intervention Description~        1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary~          arch as is commonly practiced in dental clinics. Information obtained before assignment~          of intervention or standard care included age, gender, type of injection given~          alongside the vibration device will be recorded beforehand. During the delivery of~          anesthesia for all the groups, anticipated and actual pain will be recorded to show the~          impact of anxiety on the experience of participants. During the entire process, all~          participants will use standard needles with confirmed specification to control for any~          potential confounders~        2. Buzzy® The use of the external cold and a vibrating Device will follow the~          manufacturer's recommendations to ensure that normal clinical scenario is created.~   "
29166|NCT02675374|"~     This single-institution randomized controlled trial prospective will enrolled 48 patients~     scheduled for an aortic valve replacement. The objective of the present investigation is to~     determine the role of Polaramine® on reducing hemodynamic instability after separation from~     cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play~     an important role reducing dysfunction of the autonomic nervous system and hemodynamic~     stability after separation from CPB.~   "
29167|NCT02675361|"~     This study is part of a larger research project known as Swedish Transition Effects Project~     Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created~     to develop and evaluate transition programs in order to support adolescents with chronic~     conditions in Sweden. While STEPSTONES has a generic nature, the first transition program~     that will be evaluated targets adolescents with congenital heart disease (ConHD).~      This particular study involves a hybrid experimental design, meaning a randomized controlled~     trial is embedded in a longitudinal, observational study. This type of design will help to~     test the effectiveness of a transition program in order to empower adolescents with~     congenital heart disease in the transition to adulthood and check for potential~     contamination of the comparison group. We will recruit 240 participants: 120 adolescents~     will be part of the randomized controlled trial (60 in the intervention arm; 60 in the~     comparison arm), and 120 participants will be assigned to the observational, longitudinal~     arm of the study, which serves as control group in an intervention-naive center. Over a~     period of two years, three assessments will be done during which all participants will be~     asked to answer a set of questionnaires.~      The intervention to be tested involves patient empowerment, education on their ConHD,~     dealing with school, health behaviors required to maintain good health, guidance of parents,~     a person-centered transition plan, among others. The study hypothesis is that adolescents~     with ConHD who received a structured, person-centered transition program over a 2-year~     period have a higher patient empowerment score than adolescents who receive usual care.~   "
29168|NCT02675348|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     beef hydrolysates extract with a regular endurance training programme on (a) body~     composition (b) performance (c) muscle structure (d) blood markers of health in athletes. As~     a second objective the investigators will analyse potential differences obtained from the~     ingestion of the new hydrolysates beef protein extract compared to the ingestion of others~     commercially available protein sources such as whey and non protein only carbohydrate~     contrast nutrients.~   "
29169|NCT02675335|"~     The purpose of the study is to test the effect of Sitagliptin on the healing of stable,~     nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.~   "
29170|NCT02675322|"~     Danlou tablets are Chinese patent medicine which has been approved in China for the~     treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac~     remodeling remains unclear. This pilot study was designed to determine whether Danlou~     tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial~     infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou~     tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the~     treatment of MI. Major end points were changes in LV volumes and ejection fractions as~     evaluated by serial echocardiography in addition to clinical outcomes were also determined.~   "
29171|NCT02675309|"~     The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of~     simvastatin and rosuvastatin in healthy subjects.~   "
29172|NCT02675296|"~     Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15~     years. The national rise in incidence of acute kidney injury has several ramifications in~     terms of cost to the health services resulting not only from cost of therapy but also from~     the later consequences of AKI from development of chronic kidney disease and cardiovascular~     disease. Mortality in patients with AKI-D is very high and remains unchanged in the last~     decade in England. In recent years it is becoming clearer that even the national incidence~     and case-fatality of AKI is influenced by regional variation. In last three decades, many~     studies have reported unwarranted variation in a wide range of procedures, from the~     performance of cesarean section and coronary angiography to the treatment of early prostate~     cancer, stroke, and the ailments of the chronically ill. In surgical care there is evidence~     that the variation may be driven by forces other than patient illness and medical~     appropriateness such as access to care and other socioeconomic factors, provider capacity of~     the local system, medical malpractice pressure, and distinctly different local practices.~     Despite the public health burden of AKI-D in England, it is unclear if regional variation~     exists in AKI-D. Variation in incidence of AKI-D in different region of a country may be~     influenced by patient and physician demographics of the regions, physician preferences or~     the nature of the hospital serving the population. To reduce the incidence and case fatality~     of AKI-D, it is imperative to understand if variations in incidence and case-fatality in~     AKI-D exists in different regions of the country.~      To address this gap in knowledge, the investigators combined national database of hospital~     admissions and discharge with census data from office of national statistic over a period of~     fifteen years to determine the trend in change in the regional incidence and case fatality~     of AKI requiring dialysis in England. The investigators also explored various determinants~     of the regional variation in the dialysis requiring AKI.~      Methods Data source The investigators extracted 2000-2015 data from the Hospital Episode~     Statistics (HES), a data warehouse containing details of all admissions, outpatient~     appointments, and A&E attendances at National Health Service (NHS) hospitals in England.~      Definitions The investigators identified all cases of AKI by using validated International~     Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any~     diagnoses codes, in keeping with the objective of the study. Patients with any of the~     following codes were included: N17.0 for acute renal failure (ARF) with tubular necrosis,~     N17.1 for ARF with acute cortical necrosis, N17.2 for ARF with medullary necrosis, N17.8 for~     other ARF and N17.9 for ARF, unspecified. ARF has been replaced by new terminology, AKI, but~     due to lack of ICD10 codes for AKI, the investigators used the ICD10 codes for ARF and~     henceforth, will be referred to as AKI in this study. The investigators also extracted all~     available secondary diagnosis and up to 24 Office of Population Censuses and Surveys~     Classification of Interventions and Procedures, 4th revision (OPCS-4) codes. To identify~     patients with AKI-D, the investigators included OPCS code of X40.3 for hemodialysis or X40.4~     for hemofiltration in any of the 25 procedures. Patients with chronic kidney disease stage 5~     (CKD-5) starting chronic dialysis and end stage renal disease (ESRD) with ICD-10 code of~     N18.5 and N18.6 respectively were excluded. The investigators also excluded OPCS-4 codes for~     Arteriovenous fistula (L74.2) or Arteriovenous graft (L74.3) during the inpatient admission.~     HES data stratifies patient location into 16 different regions. The geographic regions in~     England were stratified as per the Office of National Statistic (ONS) into nine regions:~     North East, North West, Yorkshire and Humber, East Midlands, West Midlands, East of England,~     London, South East and South West. Patients' in geographical locations outside these nine~     regions were excluded. Patients who were admitted, but were not discharged during the study~     period will not be included in the study. The investigators also obtained completed hospital~     discharges from each region to estimate the effect of hospitalization on AKI-D incidence~     rates, along with number of nephrology consultants in each region from 2000 to 2015 from~     Health and Social Care Information Centre (HSCIC) in the annual census of medical and dental~     staff in the NHS. The investigators will also obtain linkage with ONS and UK Renal Registry~     (UKRR) for long-term patient and renal outcomes. To obtain population incidence of AKI-D for~     each region, mid-year population of the region in each year from 2000 to 2015 was obtained~     from the ONS.~   "
29173|NCT02675283|"~     This study aims to assess whether it is feasible to use a point of care test to increase the~     detection of coeliac disease in a pharmacy setting.~   "
29174|NCT02675270|"~     The goal of this study is to remediate word-finding problems in patients with Primary~     Progressive Aphasia (PPA) and to delay the further progression of word-finding impairment.~     The current approach is novel in that it contains a prophylaxis component in which the~     investigators attempt to strengthen neural connections that remain functional, making them~     more resistant to degradation as the disease progresses. While the study is specific in its~     targeting of word-finding problems, a successful outcome would bode well for other studies~     aimed at prevention or reversal of declining cognitive functions in dementia. Patients with~     PPA whose naming of pictures has just begun to show signs of decline will receive practice~     with picture naming in two conditions: viewing the picture and repeating the name; and~     viewing the picture with its written name, plus reading and writing the name. Naming of~     pictures trained in each of these conditions will be compared, at three time intervals~     post-training, with naming of pictures tested before the study but never trained. A~     scene-description task containing trained items will be used to assess generalization. It is~     predicted that the pairing of the picture with its written name, combined with the motor~     task of writing the name, will result in a greater ability to name the picture at a later~     date than simple practice viewing the picture and repeating the name. Generalization to~     other exemplars and to other task situations is also predicted.~   "
29175|NCT02675257|"~     This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes~     patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes~     distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c).~     Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care~     behaviour, diabetes acceptance and quality of life. The treatment group will be treated with~     a cognitive-behavioural group treatment comprising specific interventions to improve~     glycaemic control and reduce diabetes distress as well as depressive symptoms. The control~     group will receive treatment-as-usual. A total of 212 study participants will be included. A~     secondary study objective is to analyse associations of suboptimal glycaemic control,~     depressive symptoms and diabetes distress with inflammatory markers.~   "
29176|NCT02675244|"~     The purpose of the research is to determine whether repairing a tricuspid valve (TV) in~     patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral~     valve surgery (MVS), would improve the heart health of those who receive it compared to~     those who do not.~      At this point, the medical community is split in their opinion on whether surgeons should~     routinely repair mild to moderate TR in patients who are undergoing planned mitral valve~     surgery, and this study will answer this question.~   "
29177|NCT02675231|"~     The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab~     with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+),~     human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic~     breast cancer after prior exposure to at least two HER2-directed therapies for advanced~     disease.~   "
31157|NCT02649270|"~     The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for~     psoriasis in India. The first trial in China is to evaluate the tolerability, safety,~     pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with~     psoriasis.~   "
29178|NCT02675218|"~     Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying~     antirheumatic drugs (DMARDs).~      Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis,~     biomarkers of inflammation, and bone destruction.~      Given the demonstration of correlation between joint inflammation and structural progression~     at each joint level as well as the opportunity for bone remodeling with resolution of joint~     inflammation, researchers expect to observe an improvement in bone micro-architecture~     parameters specifically in rheumatoid arthritis patients without remaining joint~     inflammation 3 months following abatacept treatment initiation.~   "
29179|NCT02675205|"~     Part of interventional neuroradiology procedures for the treatment of selected cerebral~     aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet~     therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3~     of the patients are low responders due to variation of the biological response to~     clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized~     controlled trial. It could be an option for APT due to more reproducible response with less~     interindividual variability and reduced monitoring. The aim of this study is to demonstrate~     the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing~     neurovascular stenting for cerebral aneurysm.~   "
29180|NCT02675192|"~     Aging affects almost all the tissues and physiological functions, and skeletal muscle is the~     most affected organ. The progressive decline of the weight and the muscular function linked~     to the aging contributes to the lack of autonomy and dependence, but also to an increase of~     the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in~     13-24% of 60 years old, and 50% of 80 years old and more.~      However, strong inter-individual variations of this prevalence of sarcopenia exists. The key~     issue is to understand why the biological aging of the skeletal muscle is so different~     between people.~      In this study, mechanisms involved in biological aging of the skeletal muscle in aging~     people (same chronological age) will be specified.~   "
29181|NCT02675179|"~     The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS~     and the spiral CT in women having had an obstructed delivery. If this concordance is~     demonstrated, it would allow the use of this new technique of imagery, to realize a~     pelvimetry during the pregnancy less irradiating for the mother, and the fetus.~   "
29182|NCT02675166|"~     Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is~     estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical~     complications can lead to a late risk of death. A regularly support, a therapeutic~     education, a support of the psychological difficulties have a positive impact on the quality~     of life and on long-term health for patients surviving to a cancer.~      The ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to~     2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients~     diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility~     and utility for patients and their physicians of a long-term follow-up coupled with an~     interview with a psychologist in Rhône-Alpes-Auvergne.~      The primary objective of SALTO-2 project is to know the becoming of young adults that~     survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second~     objective is in one hand to study the psychological becoming and on another hand, to~     ameliorate their lifestyle thanks to different documents created specially for them.~   "
29183|NCT02675153|"~     Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical~     rate. The present clinical trial aims to evaluate the efficacy and safety of sirolimus in~     the treatment of stricturing Crohn's Disease.~   "
29184|NCT02675140|"~     The present study is intended to supplement the preschool anemic children with vitamin A~     capsule and de-hookworm administration in poverty Sichuan province. We eventually expect our~     study can provide a cost-effective, safe and more beneficial public health strategy to~     manage the anemia status of preschool children in poverty area.~   "
29185|NCT02675127|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European~     Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers~     Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition~   "
29186|NCT02675114|"~     To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve~     in patients with severe, calcific aortic stenosis who are at low operative risk for standard~     aortic valve replacement (AVR).~   "
29187|NCT02675101|"~     Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very~     long half-lives. POPs are endocrine disruptors, associated with increased risk for diabetes,~     alterations in thyroid function, and cardiovascular disease in humans. POPs concentrations~     increase with age because of their persistence, bioaccumulation and poor excretion. The~     almost ubiquitous presence of endocrine disrupting POPs in US adults is a substantial public~     health concern, particularly because there is no established treatment to reduce body~     concentrations of POPs. Most POPs are excreted in bile due to their lipophilic nature.~     However, a substantial amount is reabsorbed in the small intestine and returns to the blood~     stream (entero-hepatic circulation). The objective of this pilot study is to conduct a~     6-month randomized controlled trial of Nuts and Olestra to enhance the excretion of POPs~     among 45 healthy adults aged 45 to 70 years with BMIs between 18-30 kg/m2. This study has 3~     treatment arms: A) Whole nuts with high fat content (almonds and walnuts; 110g total/day,~     n=15), B) Olestra: Fat Free PringlesTM potato chips (≈29 crisps, 18g of Olestra/day; n=15),~     C) Vegetable oil: Original PringlesTM potato chips (≈29 crisps, 17.4g of oil/day; n=15). The~     investigators aim to measure change in concentrations of 24 POPs in feces after 4 days of~     treatment and in blood at 6 months.~   "
29188|NCT02675088|"~     Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo~     chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A~     Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of~     3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT~     group. But intrathoracic progression was still high, either with or without progression~     elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is~     undefined. Maybe higher dose can provide better local control(LC) and overall survival. In~     this study, the investigators propose to give an increased dose of TRT to determine whether~     higher dose will improve 2-year OS, LC and progression-free survival.~   "
29189|NCT02675075|"~     A disease called Amyotrophic lateral sclerosis (or ALS), which leads to difficulty~     swallowing, breathing, and movement, has been found to be higher for those serving in the~     military than in the general population. There are approximately 4,200 Veterans with ALS and~     roughly 1,000 new cases each year. When doctors attempt to determine the degree to which an~     ALS patient is suffering from the disease, they apply tests that are graded by experts.~     However, this approach to testing patients may not be very accurate. Researchers aim to use~     a system called DESIPHER to listen to ALS patients and find speech mistakes related to~     their condition. Researchers believe that, by detecting different types of errors, DESIPHER~     serves as a new kind of indicator of medical problems such as difficulty breathing or~     swallowing, without human grading. This may also lead to a better system for automatically~     understanding ALS patients' speech.~   "
29190|NCT02675062|"~     The purpose of this study is to determine whether habitual physical activity and sedentary~     behaviour improve six weeks and between three to six months after total knee replacement~     surgery in people with osteoarthritis.~   "
29191|NCT02675049|"~     This trial is going to evaluate the safety and effectiveness of intranasal~     DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the~     optimal dose of intranasal DEX in breast lumpectomy.~   "
29192|NCT02675036|"~     The purpose of this study is to see whether extraction of the primary canine tooth or~     extraction of both the primary canine - and the primary first molar tooth is most effective~     in the treatment of palatally ectopic canine teeth in the maxilla. In addition the study~     will also measure pain and discomfort in relation to these two treatment alternatives.~   "
29193|NCT02675023|"~     This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg)~     subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe~     (PFS) in healthy subjects.~   "
29194|NCT02675010|"~     There are controversies about the best sites -biopsy based -tests for H pylori associated~     gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for~     identification of Helicobacter pylori, especially in case of gastric atrophy and/or~     intestinal metaplasia.~   "
29195|NCT02674997|"~     The purpose of this study is to investigate the feasibility and acceptability of the~     Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported~     outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in~     individuals with hemophilia A.~   "
29196|NCT02674984|"~     This study will evaluate the safety and tolerability of combination probiotic BB-12 with LGG~     in healthy children with autism spectrum disorder aged 6-13 years. Subjects will be~     randomized to BB-12 with LGG orally (LGG dose: 10^9 c.f.u.'s; BB-12: 10^9) for a total of 28~     doses or placebo (maltodextrin) at 2:1 ratio. The time on study treatment is 28 days, and~     the target sample size is 45 individuals (i.e., 30 in the treatment arm and 15 in the~     placebo arm).~   "
29197|NCT02674971|"~     For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One~     dietary strategy that may facilitate reducing energy intake and enhancing weight loss is~     consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the~     ratio of energy of the food to the weight of the food (kcal/g), is largely determined by~     water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines~     encourage an eating pattern low in energy density (ED) to manage weight, it is currently not~     known what the best strategy is for reducing ED in the diet. Eating a greater number of~     foods low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As~     ED is believed to reduce intake by allowing a greater weight of food relative to total~     energy consumed assisting with enhancing feelings of fullness, it is anticipated that either~     increasing consumption of low-ED foods in the diet alone or combining an increase in~     consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best~     strategies for reducing overall dietary ED for weight loss.~   "
29198|NCT02674958|"~     Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of~     endothelial progenitor cells (EPCs).~   "
29199|NCT02674945|"~     This project attempts to correlate wireless activity data with quality of life and sleep~     surveys in order to find a new method of monitoring patients during their treatment.~   "
29200|NCT02674932|"~     Research has shown that identifying and using one's character strengths in new ways~     decreases depressive symptoms and increases happiness in adults in the general population.~     Recently, we found that a similar intervention increases the self-esteem and self-efficacy~     of children and adolescents being treated in an inpatient psychiatric unit. The purpose of~     this study is to better understand the effects that discovering one's character strengths~     and incorporating them into coping skills will have on treatment outcomes in patients~     admitted to a child and adolescent inpatient psychiatric unit.~   "
29201|NCT02674919|"~     The purpose of the study is to investigate the efficacy of a 10-week intervention, using the~     Nordic Hamstring exercise, on repeated-sprint ability in male sub-elite football players.~     The primary outcome measure is total sprint time during 4x6 sprint of 10 meters measured~     using dual-beam photoelectric cells. Additionally, eccentric knee flexor strength is~     measured using the Nordbord hamstring strength measure. The hypothesis is that strength~     training of the knee flexor muscles elicited by the Nordic Hamstring exercise will result in~     enhanced repetitive sprint-ability expressed as a decrease in total sprint time.~     Furthermore, baseline data is used to assess to correlation between eccentric hamstring~     strength and active hamstring flexibility AND sprint performance.~   "
29202|NCT02674906|"~     The primary aim of this randomized controlled study is to determine whether the use~     Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces~     inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim~     is to determine whether any differences in activation can be correlated to any differences~     in postoperative clinical outcome.~   "
29215|NCT02674737|"~     To evaluate the efficacy and safety of appropriate postoperative sedation with~     dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was~     conducted from October 2015 and December 2015 among patients after gastrectomy. The~     investigators are going to enroll patients who received abdominal surgeries. One group~     receive sedative along with analgesic and the other group analgesic only for the other group~     on the first 24 hours after surgeries and follow up for 3 days.~   "
29203|NCT02674893|"~     This is an open-label comparative study in three parallel groups. It is expected that 90~     patients and/or healthy volunteers will participate in this biomedical research.~      Distribution in groups~        -  30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue~          (group 1)~        -  30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins~          (group 2)~        -  30 healthy subjects (non-diabetics) (group 3)~      This study will investigate modifications in eating behaviour induced by Liraglutide in~     patients who start treatment with Victoza® and certain aspects, such as liking (hedonic~     characteristic of a food), wanting (desire to eat a given food) and salivation in response~     to the presentation of a food by taking measurements at D0 (before initiation of the~     treatment with Liraglutide in the group concerned) then at 15 days (except for the~     controls), 3 months and 9 months (only for controls).~   "
29204|NCT02674880|"~     The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients~     admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of~     COPD.~   "
29205|NCT02674867|"~     The study aims to define and compare the immunological characteristics (lymphocyte~     subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory~     parameters) and the virological characteristics (study of viral reservoir) between 2 groups~     of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before~     6 months-of-age (early treatment group) or after 24 months-of-age (late treatment group)~     with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24~     months after the start of cART), whatever the later evolution of the viremia.~      Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in~     each group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA~     measures <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations~     and study of the inductibility of the viral reservoir.~   "
29206|NCT02674854|"~     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to~     netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%~   "
29207|NCT02674841|"~     This study investigates if live feedback during home-based exercises will improve the~     ability to perform the exercises with the prescribed time under tension (TUT) per repetition~     compared with no feedback among adolescents with patellofemoral pain. The hypothesis is that~     adolescents who receive live feedback from BandCizer™ will have a mean TUT that is~     significantly closer to the prescribed TUT compared to the group not receiving feedback~     during the course of the intervention.~   "
29208|NCT02674828|"~     The purpose of this pilot study is to evaluate the initial efficacy of a reinforcement~     intervention to enhance physical activity levels in sedentary adolescents and young adults~     with type 1 diabetes (T1D). The intervention will reinforce patients for meeting physical~     activity goals, with escalating reinforcers provided when patients achieve continuous weeks~     of meeting goals. A 12-week trial will be conducted in which 60 patients will be randomized~     to: (1) standard care or (2) standard care plus reinforcement.~   "
29209|NCT02674815|"~     Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome~     including complications, mortality and increased length of stay. Preoperative physical~     fitness is protective against poor postoperative outcome in intra-abdominal and thoracic~     surgery.~      The current colorectal/thoracic pathway from diagnosis to surgery is about 2 weeks and~     therefore interventions of longer duration are not feasible. Clinicians may be presented~     with a difficult choice in delaying surgery to perform prehab or cancel the pre-op~     intervention.~      To create greater improvements in aerobic fitness, participants are required to exercise at~     high levels of VO2peak (e.g. ≥80% VO2peak). High intensity interval training (HIIT) requires~     participants to exercise at high levels of VO2peak (≥80% VO2peak) for short periods (e.g. 15~     seconds) followed by a recovery (active or passive) and typically continue this pattern for~     30 minutes or until exhaustion.~      HIIT programmes are safe and a recent meta-analysis noted that HIIT produced a more~     pronounced incremental gain in participants' mean VO2peak when compared with continuous~     moderate intensity exercise (+1.78mL/kg/min, 95% CI: 0.45-3.11).~      HITT has not been investigated as a preoperative intervention to either optimize fitness~     prior to surgery or reduce post-surgical complications. Preoperative HIIT is an intense~     intervention which will require significant participant adherence. The safety, cost and~     clinical application of such a programme needs to be performed. This feasibility study aims~     to assess the ability of HIIT to improve aerobic fitness two weeks prior to surgery and~     determine its feasibility.~   "
29210|NCT02674802|"~     Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and~     gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection~     rates of Helicobacter pylori is still high, so effectively eradication is necessary. At~     present, the eradication therapy has achieved very good curative effect. However, relapse~     after eradication is unoptimistic. This study has made an analysis for reinfection after~     eradication of Helicobacter pylori Infection include the retrospective and prospective~     studies, aims to explore the epidemiological data and related risk factors of Hp reinfection~     in China.~   "
29211|NCT02674789|"~     Ionized magnesium variation is measured during a normal day and again during a day with an~     exercise protocol of 90 minutes.~   "
29212|NCT02674776|"~     This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients~     with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule~     treatment group and Placebo control group. Randomization codes were established by the~     biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of~     VAS score from baseline, proportion of improvement with damp-heat retention, change in~     C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in~     white blood cell count in whole blood cell analysis from baseline, and the number of adverse~     events will be monitored and compared between each groups.~   "
29213|NCT02674763|"~     This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and~     RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive~     disease.~   "
29214|NCT02674750|"~     This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and~     safety of CUDC-907 monotherapy and R-907 (rituximab in combination with CUDC-907) in~     subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell~     Lymphoma (DLBCL).~   "
29216|NCT02674724|"~     To investigate if resistance training exercises performed twice a week with or without gym~     equipment assistance in a 12-week period could improve balance in patients with Parkinson~     Disease (PD).~      Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and~     preserved cognitive function will participate in this study. Patients will be randomized~     among three intervention groups: resistance training with free weights, resistance training~     with gym equipment and control group. Investigators will use static platform balance~     variables to assess the primary end-point outcome measures. For the secondary outcomes~     measures, most common clinical functional balances tests for PD will be applied: Berg~     Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test~     (TUG) and variables from dynamic posturography.~   "
29217|NCT02674711|"~     The purpose of this project is to assess the impact of an educational video on the use of~     prescription opioid medication during a 6-month period following spine surgery. Subjects~     will be recruited from the pool of patients coming in for the pre-operative appointment~     prior to spine surgery. Patients that consent and enroll will be randomized to receive~     either a brief educational video at this appointment or usual care. Patients will be~     followed after surgery weekly for the first month, and then again at 6 months to determine~     their prescription opioid medication utilization patterns. Prescription data will also be~     pulled from electronic medical records.~   "
29218|NCT02674698|"~     Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard~     implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and~     to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition~     and safety outcome measures derived from Veteran-specific CMS data.~      Methods: The investigators will evaluate the effect of the CNH Dashboard release in a~     randomized, stepped-wedge dissemination. This dissemination design allows us to determine~     the impact of the CNH Dashboard on the quality of purchased CNH facility more systematically~     than a single phase roll-out. In each of the 4 steps, The investigators will release the CNH~     Dashboard to a randomly selected set of VISNs. Dashboard release will be accompanied by~     education.~      Findings: The CNH Dashboard has actionable information to leaders in GEC at the local,~     regional, and national levels.~      Impact: When completed, this program will improve the quality of care Veterans receive in VA~     purchased CNH programs as demonstrated by improved selection of CNH facilities and~     Veteran-specific measures.~   "
29219|NCT02674685|"~     Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under~     general clinical practices.~   "
29220|NCT02674672|"~     To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter~   "
29221|NCT02674659|"~     This research will add resistance training to patients who undergo cardiac rehabilitation~     program after coronary bypass surgery, comparing the level of PCSK9 level on that group to~     another group who receives conventional rehabilitation program (only aerobic exercise)~   "
29222|NCT02674646|"~     The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment~     parallel to radiation therapy in oncological patients. The trial is designed as a two-armed~     trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be~     applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy,~     thereafter weekly until the end of radiotherapy; the follow-up visits include clinical~     workup as well as questionnaires.~   "
29223|NCT02674633|"~     The purpose of this study is to evaluate the effects of videogame-like digital therapies on~     attentional functioning and symptoms in children diagnosed with ADHD.~   "
29224|NCT02674620|"~     A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of~     continued mental and physical rest to minimize symptoms. However, this conservative approach~     does not consider the pathophysiological mechanisms and neurological subsystem dysfunction~     which mediate persistent signs and symptoms. Recently, developing research is recommending~     targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and~     cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that~     has emerged as safe, reliable, and effective in distinguishing between post-concussion~     syndrome sub-types, quantifying physiological recovery, and guiding return to play decision~     making. It has been proposed that the results of a BCTT can be used to prescribe~     progressively intensifying whole body aerobic exercise (such as walking or biking),~     maintained at a sub-symptom threshold, to improve autoregulatory function with the potential~     to improve PCS symptoms. Positive results with BCTT have now made it the standard of care at~     the University of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport~     related concussions. Despite its increased use in patients with post-concussion syndrome~     there is currently no data on the use of exercise treatment in the early stages of~     concussion recovery.~   "
29225|NCT02674607|"~     The aim of this study is to evaluate the possible immunologic effects of spirulina in~     children with beta thalassemia.~   "
29226|NCT02674594|"~     The overall objective of this proposal is to execute a real-world database analysis to~     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)~     patients in the U.S~      Primary objective: To determine the proportions of NVAF patients with bleeding-related~     hospital readmissions that occur within 30 days of the hospitalization of NVAF patients~     treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or~     warfarin in the inpatient setting~      Secondary objectives:~        -  To determine the cost associated with bleeding-related hospital readmissions that occur~          within 30 days of the hospitalization of NVAF patients treated with dabigatran,~          rivaroxaban, apixaban or warfarin in the inpatient setting~        -  To determine the proportions of NVAF patients with all cause hospital readmissions and~          the associated costs that occur within 30 days of the hospitalization of NVAF patients~          treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.~   "
29227|NCT02674581|"~     An oral dose in healthy and renally impaired subjects to determine the drug effect for~     BMS-663068.~   "
29228|NCT02674568|"~     The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a~     third-line and later treatment for subjects with relapsed or refractory delta-like protein 3~     (DLL3) expressing small cell lung cancer (SCLC).~   "
29229|NCT02674555|"~     This is a study to investigate the absorption, metabolism and excretion of [14C] labeled~     ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This~     study consists of two parts (A and B).~   "
29230|NCT02674542|"~     Women who have experienced a stillbirth or neonatal death are at higher risk of repeated~     poor neonatal outcomes if they have short interpregnancy intervals. Understanding the~     attitudes surrounding future fertility and contraception in this population is critical to~     propose socially and culturally acceptable interventions to address an unmet need for family~     planning.~      Participants: Women who have experienced a stillbirth or early neonatal death will be~     recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.~      Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four~     focus group discussions of up to 10 women each.~   "
29231|NCT02674529|"~     The proposed work aims to examine the neural changes associated with fast-acting~     antidepressant treatments in order to develop imaging-based biomarkers of treatment response~     for depression.~   "
29232|NCT02674516|"~     This study investigates the relationship between prefrontal cortex activity and antisocial~     and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized~     controlled trial, participants will undergo three sessions of anodal transcranial direct~     current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete~     survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate~     and skin conductance will also be measured.~   "
29233|NCT02674503|"~     After hospitalization, many older adults experience more difficulty getting around in the~     community and performing one or more of their basic activities of daily living (ADLs) like~     bathing or dressing. The goals of this study are to test the effectiveness of a mobility~     intervention, compared to usual care, on change in mobility after hospitalization, to~     determine the impact on one-year outcomes such as nursing home placement and to identify~     which Veterans benefit the most from the intervention. Ultimately, the goal is to improve~     recovery after hospitalization and reduce disability in hospitalized Veterans.~   "
29234|NCT02674490|"~     The investigators will study the effects of transcranial direct current (tDCS) stimulation~     during language therapy for naming in individuals with aphasia in the acute and subacute~     post stroke period. Naming difficulties are a persistent and common symptom in aphasia after~     left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the~     mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS)~     is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful~     electrical stimulation of the brain which modulates cortical excitability by application of~     weak electrical currents in the form of direct current brain polarization. It is usually~     administered via saline-soaked surface sponge electrodes attached to the scalp and connected~     to a direct current stimulator with low intensities. Most studies are conducted in the~     chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is~     reason to believe tDCS might be most effective in the acute-subacute period. However, only~     two studies have evaluated tDCS paired with language therapy in group studies of acute to~     subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no~     studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post~     stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the~     investigators will evaluate whether tDCS combined with SALT improves naming in individuals~     with aphasia in the acute and subacute post stroke period, more than SALT alone in a~     randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis~     that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated~     with greater gains in accuracy in naming pictures, compared to sham combined with the same~     computer-delivered SALT in post stroke aphasia.~   "
29235|NCT02674477|"~     This research is being done to study whether using an Internet-based program, called the~     Therapeutic Education System (TES), would be helpful for the treatment of substance use and~     other psychiatric problems.~   "
29236|NCT02674464|"~     The investigators refined research aim is to determine if a clinic-based collaborative care~     team, including a community health worker (CHW) to deliver community-based contextualized~     care, reduces disparities in blood pressure control rates, lowers cardiovascular disease~     (CVD) risk, and improves outcomes among patients with hypertension and other common comorbid~     conditions when compared to standard of care health system approaches to CVD risk~     management, including audit and feedback and staff and provider training.~      Collaborative care includes care coordination and care management; regular and proactive~     monitoring and treatment to target specific patient needs using validated clinical tools and~     rating scales; and regular systematic caseload reviews by the care team and consultation~     with experts for patients who do not show clinical improvement. A typical collaborative care~     team includes the primary care provider, nurse care manager or coordinator, PharmD, clinical~     social worker, nutritionist, and other members of the clinic staff involved in patient care.~      Intervention protocols will be designed to address common comorbidities (diabetes,~     hyperlipidemia, depression and coronary heart disease), lifestyle factors (dietary intake,~     physical activity, and smoking) and medication adherence. The investigators intensive~     intervention will treat the whole patient, driven by individual patient goals and~     priorities, as opposed to the standard of care, which typically focuses on individual~     conditions. This proposed study responds directly to patient desires to feel more equipped~     to be involved in their care and manage multiple conditions that contribute to CVD. The~     investigators have worked successfully in the past with a broad range of stakeholders,~     including community members, patients, providers, and payors, and will continue to engage~     them through the research and dissemination process.~   "
29237|NCT02674451|"~     Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of~     coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of~     CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found~     CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year~     mortality in patients with coronary artery disease. Intravenous contrast dye is felt to~     cause renal ischemia as the mechanism of injury. Unfortunately, despite the significant~     morbidity and mortality with CIN, there are few therapeutic interventions to reduce the risk~     with the exception of hydration and high dose statin therapy. Recently, remote ischemic~     preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood~     pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic~     cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and~     even cerebral injury following coronary bypass grafting. While there is significant data~     supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there~     is only one small trial studying RIPC in patient's undergoing coronary angiography. The~     investigators hypothesize that RIPC will reduce the incidence of contrast-induced~     nephropathy in patients with baseline renal dysfunction undergoing coronary angiography for~     stable or unstable coronary artery disease.~   "
29246|NCT02674334|"~     The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on~     participants undergoing shoulder surgery in the beach chair position to determine cerebral~     desaturation events and to further determine cognitive changes pre and post surgery using~     the Mini Mental State Exam.~   "
29247|NCT02674321|"~     The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of~     SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the~     pharmacokinetic of SD-809 and its metabolites.~   "
29248|NCT02674308|"~     The purpose of this study is to assess the long-term safety of vedolizumab versus other~     biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).~   "
29238|NCT02674438|"~     Heart failure is a condition where the heart pump does not function normally causing the~     lungs to become congested. The primary symptom of heart failure is shortness of breath, and~     this often leads to patients visiting the emergency department for care. Decision-making in~     the emergency department is a high-stakes situation, where there is a need for decision~     support to guide clinicians to make better decisions about admission to hospital or~     discharge home. Many low-risk patients who could potentially be managed at home are admitted~     to hospital whereas some patients who are thought safe to discharge are actually high risk~     and will have adverse outcomes if they are discharged home from the emergency department.~      In this trial, the investigators will study a new strategy for heart failure care, comprised~     of a computer algorithm to help doctors make decisions in the emergency department about the~     risk of their patient. For low-risk patients who are discharged home from the emergency~     department or after a short hospital stay, patients will be referred to a rapid follow-up~     clinic where the heart specialist team will rapidly assess and treat patients.~   "
29239|NCT02674425|"~     Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high~     cost, lack of easy portability, need of trained staff and a totally dark room to be~     operated, arbitrary testing procedures, associated time waste in clinic and patient burden~     to mention a few. Consequently, dark adaptometers are not routinely used as clinical tools~     for retinal diagnosis and monitoring despite the inherent benefits over other visual~     electrophysiology equipment such as the ERG system, whose cost and features may often be~     surplus to optometrists' requirements.~      This trial will assess the dark-adaptometry testing performance of a novel light-emitting~     system by generating full dark-adaptation threshold functions in normal adult healthy~     volunteers.~      The novel system has been proposed to overcome the issues associated with current~     instrumentation; it is semi-automatic and easy to use without the need of any skilled~     operator.~      It is envisaged that this system could spread the practice of dark-adaptometry testing and~     its adoption by high-street optometrists. This will allow diagnosing a number of retinal~     pathologies more quickly and more reliably that, faced with an ageing population, represents~     a major asset to the Health Community and the NHS.~      This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of~     18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the~     participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry~     testing 3 times on separate days within 3 weeks.~      Testing will clarify whether by using the novel system it is possible to reproduce~     state-of-the-art threshold measurements as good or better than those produced by~     commercially-available dark-adaptometers. Threshold measurements in the elderly will be~     compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis~     contributions. Data variability and system usability will be also assessed.~   "
29240|NCT02674412|"~     This study evaluates the utility of buspirone in patients who have a diagnosis of functional~     dysphagia. All participants will be randomized to receive either a placebo pill or~     buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants~     who were randomized to receive placebo will then receive buspirone and those who were~     receiving buspirone will receive placebo. We will again evaluate whether their swallowing~     improved.~   "
29241|NCT02674399|"~     This study is a double-blind, randomized, controlled study with two arms to evaluate~     JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening~     period, approximately 45 subjects will be randomly assigned into one of the following two~     arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes~     6-month visit (Visit 6) and the data management team confirms all data have no issue, the~     database will be locked and the blinding will be open for the statistical analysis. Subjects~     will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).~   "
29242|NCT02674386|"~     A4091064 is a multicenter, long-term observational study of subjects from tanezumab~     interventional studies (regardless of treatment group) who undergo a total knee, hip or~     shoulder replacement during participation in the study. The study is designed with a total~     duration of subject follow-up of 24 weeks after the total joint replacement surgery. There~     will be two methods of data collection utilized in this study: interview by site staff via~     the telephone and interactive web-response system (or paper if the subject has no access to~     the internet).~   "
29243|NCT02674373|"~     The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated~     by computer tomography scans with RECIST criteria that are performed every two months during~     the treatment. The management of treatment for gastric cancer needs the development of early~     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early~     chemotherapy resistance. In this prospective study, we will compare the monitoring of~     circulating tumor DNA with the results of CT scan according the RECIST criteria and the~     blood level of CEA and CA 19-9 tumor markers.~      Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of~     tumor response according to the tumor DNA circulating assessment in gastric cancer~     treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it~     would be continued uselessly, (ii) and to allow a early changing to an alternative~     chemotherapy regimen.~   "
29244|NCT02674360|"~     Cancer patients often report that they are not included in important treatment decisions.~     Numerous studies have shown that a training concerning Shared Decision Making (SDM) for~     physicians can improve this situation. This does not only lead to a better quality of the~     doctor-patient interaction, but may have a positive long term impact on treatment adherence,~     the psychological well-being and the coping abilities of the patients. However, previous~     experience regarding the implementation of SDM training programs show that it is difficult~     to recruit physicians for an external SDM group training due to the extensive workload of~     the physicians. In light of the available evidence on the effectiveness of SDM training and~     the low motivation by oncologists for traditional SDM group training, this study aims to~     develop and evaluate a brief SDM intervention. This intervention is disseminated in two~     different ways which both might be attractive for oncologists. On the one hand an individual~     face-to-face context-based SDM training is designed and conducted by a trainer at the~     workplace of the participating oncologists. On the other hand a web-based SDM online~     training is developed. Both SDM interventions are developed on the basis of an SDM manual~     evaluated in previous studies.~      This study therefore aims to examine the effectiveness of different disseminations~     strategies (individualized face-to-face context-based SDM individual training vs. web-based~     SDM online training) compared to a control group without any training. It will be analyzed~     which improvements in medical SDM competence can be accomplished by the different SDM~     trainings. Further the effects of the training on SDM knowledge, quality of the~     doctor-patient interaction and SDM self-efficacy expectation will be evaluated.~   "
29245|NCT02674347|"~     Study to evaluate the safety and tolerability of multiple escalating doses of intravenous~     (IV) Zidebactam in healthy adult human subjects.~   "
29252|NCT02674256|"~     Introduction and aim~      Stress is well known to affect visceral sensitivity in Human. The investigators speculate~     that visceral hypersensitivity plays an important role in symptom perception in~     gastro-esophageal reflux disease (GERD). The role of acute stress mimicked by corticotrophin~     releasing hormone (CRH) administration on esophageal sensitivity has not been studied. The~     investigators hypothesize that stress mediated through CRH-release increases esophageal~     sensitivity. A first step in the investigation of this hypothesis is to study whether~     administration of CRH has an influence on esophageal sensitivity in healthy volunteers (HV).~     Therefore, the aim of this study is to investigate the effect of CRH-administration on~     esophageal sensitivity in a group of HV.~      Methods~      The study will be performed in cross-over on 15 HV with no prior history of digestive~     disease. Esophageal sensitivity will be tested by multimodal stimulation on two sessions~     (placebo and CRH-administration), with an interval at least of one week. The two sessions~     will be scheduled by randomization for every subject. After blinded administration of CRH~     100µg or placebo IV, esophageal sensitivity will be assessed using a multimodal esophageal~     stimulation probe which allows thermal, mechanical, electrical and chemical stimulations of~     the esophagus. Esophageal sensitivity will be assessed using Visual Analogue Scale (VAS),~     the mood with specific questionnaires (Manikin Self assessment SAM, Profile of Mood Schedule~     (POMS, State Trait Anxiety Inventory (STAI)) and the cortisol with salivary samples.~      Statistical analysis~      Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical)~     will be compared between CRH and placebo conditions. To determine the stress-inducing~     capability of CRH-administration, the POMS questionnaire, STAI, Manikin self assessment and~     cortisol levels after the stress-protocol will be compared with the basal measurements.~      Perspectives~      If CRH-administration increases esophageal sensitivity, a stress model could be applied to~     investigate the influence of a real life stressor on esophageal sensitivity in healthy~     subjects. In a third part, a mast-cell stabilizing drug could be tested after administration~     of a stressor in order to investigate its role on esophageal sensitivity. In the future,~     this might be proposed to refractory GERD in a controlled randomized trial.~   "
29253|NCT02674243|"~     This is prospective randomized control trial study. The aim of this study is to evaluate the~     efficacy of Iodopovidone solution for pleurodesis in palliative malignant pleural effusion~     (MPE) patients comparing to Talc. All adult patients who diagnosed MPE by cytology~     regardless primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn~     Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this~     study. The inform and consent will be applied in all patients before treatment. Patients~     will be randomized to two groups; Iodopovidone group (intervention group) and Talc group~     (control group)~   "
29254|NCT02674230|"~     This study aims to study the relationships between obesity, circadian rhythm, and aging. The~     investigators set up a prospective cohort registry for morbid obesity, obesity, and normal~     subjects with annual follow-up. The cohort aims to investigate the pathophysiological,~     molecular, genetic, and cellular aspects of the relationships between obesity, circadian~     deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and~     molecular signatures will be collected and investigated.~   "
29255|NCT02674217|"~     Multiple sclerosis (MS) is a chronic, inflammatory, debilitating disease that causes~     destruction of central nervous system (CNS) myelin, with varying degrees of axonal damage.~     It mainly affects young adults and is twice as common in women as in men (1). Studies~     published from the 1990s brought animal models and theoretical considerations of~     hematopoietic stem cell transplantation (HSCT) being useful in the prevention and treatment~     of autoimmune diseases, with clinical responses in some patients, suggesting that high-dose~     chemotherapy followed by HSCT rescue could reset the immunological changes through the~     control of autoreactive clones, followed by immunological tolerance after immune~     reconstitution (2); this led to the conclusion that HSCT may be a viable therapeutic option~     for MS (1-6). Autologous HSCT have been done in patients with MS since 1996 and more than~     700 HSCTs have been performed around the world (1-6). Most patients have been treated in~     small trials or in multicenter studies. In retrospective analyzes, a progression-free~     survival of more than five years after transplant has been observed, the neurological~     outcomes being considerably more favorable in patients with the relapsing-remitting type~     and/or those who showed an inflammatory pattern in magnetic resonance imaging (MRI) during~     the pre-transplant screening. Reports of good results, particularly in the aggressive forms~     of MS reinforce the effectiveness HSCT in MS patients with prominent inflammatory activity.~     The risk of transplant related mortality in HSCT for MS was conventionally considered very~     high but has declined since 2001 to 1.3% (2-6), this probably being the result of the~     changes in the conditioning regimens, thus reducing toxicity. Recent data, with more than~     700 autologous transplants for MS in Europe, showed an overall survival of 92% in five years~     and a progression-free survival of 46%, the main cause of mortality and morbidity being the~     recurrence of the autoimmune disease (2-6). The consensus provides an indication of HSCT in~     patients with progressive MS unresponsive to conventional therapy and Expanded Disability~     Status Scale (EDSS) (1) between 3.0 and 6.0. The forms of the disease that might benefit~     from transplantation are: relapsing remitting, primary or secondary progressive, and the~     malignant form, provided there is evidence of inflammatory activity at the time of~     transplant indication.~   "
29256|NCT02674204|"~     The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on~     changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce~     or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast~     cancer patients.~   "
29257|NCT02674191|"~     Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may~     be done by several methods as high pull headgear and posterior bite planes or surgically by~     maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as~     mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize~     patient cooperation and the need for surgical treatment.~   "
29258|NCT02674178|"~     All women had normal uterine cavity determined by previous hysterosalpingography or~     hysteroscopy. Women with abnormally low Gn as hypothalamic hypogonadism , High LH as PCOS~     and women with abnormal endocrine functions as abnormal thyroid or adrenal functions were~     excluded. Any woman with ovarian cyst or azopermic male partner was also excluded.~      The patients were subjected to history taking, including age, duration, type and cause of~     infertility and medical history. Full examination including general and abdominal and~     vaginal examination was done followed by ultrasound evaluation for presence of 3 or more~     pre-antral follicles and exclusion of ovarian cysts.~      Basal day 3 hormonal evaluation for FSH, LH and E2 in a natural cycle was done. E2, FSH and~     LH levels were determined using Immulite system (Siemens Healthcare diagnostics,UK).The~     intra- and inter-assay coefficients of variation were 15% and 16% for E2, 4.8% and 26% for~     LH. FSH analytical sensitivity was 0.1 mIU/ml.~      All participants underwent long protocol. Daily SC injection of Triptorelin : Decapeptyl 0.1~     mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle~     and continued till the day of hCG injection. Gn stimulation started after fulfilling~     stimulation start criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l [18]~     with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a~     starting dose of 150-300 IU/day depending on patients age and previous gonadotropin~     response. then the dose was adjusted according to ovarian response monitored by serum E2 and~     ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily~     or on alternate days according to the ovarian response to treatment starting on treatment~     cycle day (6) for folliculometry and endometrial thickness and pattern.~      Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when at least 2 follicles~     reached a mean diameter of 18 mm [18]~      Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed~     no adequate follicular growth (<3 mature follicles).~      Ovum pick-up (OPU) was done 34-36 hours after hCG injection under transvaginal ultrasound~     guide.~   "
29299|NCT02673645|"~     This research aims to continue to study the effectiveness of a promising academic~     intervention (implemented by SAGA Innovations) that has previously been shown to~     significantly improve academic outcomes for disadvantaged youth. In addition, this study~     will begin to investigate the effects of scaling up this promising strategy by exploring~     variation in tutor effectiveness and the optimal instructor-student and student-student~     pairings for improving academic outcomes.~   "
29300|NCT02673632|"~     The investigator suggests that PCOS women with high AMH levels are resistant to ovarian~     stimulation and may need adjustment of the dose of gonadotrophin.~   "
29259|NCT02674165|"~     The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of~     the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that~     consists of eight sessions lasting approximately two hours each over a twelve- week period.~     The comparison group will receive a nutrition intervention during the same time period. The~     primary goals of the evaluation are to determine the effectiveness of the HART program on~     delaying initiation of sexual intercourse, reducing number of sexual partners, and~     increasing abstinent behavior and contraception use among those who were sexually~     experienced at baseline.~      Over a five semester period, the programs will be implemented in 7 or more schools in the~     greater Boston area, with offerings in the fall, the spring and summer, among approximately~     780 male and female Haitian students. The programs will recruit 9th & 10th grade Haitian~     students who will range in age from 13 to 19 years old. We will implement a randomized~     controlled trial in which each semester, students within schools will be stratified by~     gender and then randomly assigned to participate in the HART or the nutrition condition.~     Students will be recruited annually and enrolled until the summer of 2015. During the spring~     and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During~     year three, 180 youth will be randomly assigned to condition each semester (360 youth total~     during Year 3). During year four, 180 youth will be randomly assigned in the first semester,~     and 120 youth will be randomly assigned in the second semester (300 youth total during Year~     4). The number of times student-level randomization will occur and the number of groups~     formed will vary depending on the size of the 9th and 10th grade Haitian population served~     in each school.~   "
29260|NCT02674152|"~     This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI~     836880 administered intravenously. The eligible patient population will be patients with~     advanced solid tumours. At any time during the trial, it will not be permitted to escalate~     to a dose which does not fulfil the escalation with overdose control (EWOC) criterion~   "
29261|NCT02674139|"~     The study aims to compare immediate post-placental (within 10 minutes of placenta delivery)~     intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at~     6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes~     (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.~   "
29262|NCT02674126|"~     A newborn's recognition and preference for their mother's voice occurs early in life, very~     likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral~     processing that lends support for the existence of neurophysiologic mechanisms that reflect~     a child's preference for his/her mother's voice. This study aims to evaluate and compare the~     effect t of maternal sound listening in children undergoing cardiac surgery on stress~     response and physiological parameters.~   "
29263|NCT02674113|"~     The purpose of this research is to determine differences in outcomes in patients who receive~     regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip~     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.~   "
29264|NCT02674100|"~     The purpose of this study is to create a registry to provide insight into treatment~     selection and treatment outcome of pancreatic IRE in order to develop an evidence base such~     that physicians can provide the best possible care to patients with pancreatic cancer~     requiring surgical interventions.~   "
29265|NCT02674087|"~     The purpose of this survey is to collect data from intrauterine life until the age of 18 of~     children born in Haute Vienne.~      The interest to realize such survey is to find correlations and interactions that may exist~     between the events that occurred during intrauterine life and those that will occur after~     the birth of the child. The investigators will examine every aspect of these children's~     lives from the perspectives of health, social sciences and environmental health~      These are medical events (occurrence of disease, medication), but also socio-cultural for~     this child (living environment, exposure to possible contaminants, events in family~     history).~      This cohort aims to include 3000 children a year (whose parents consented to their~     inclusion), all born at Haute-Vienne.~   "
29266|NCT02674074|"~     Measurement of corneal temperature gives indirect information about the ocular blood flow.~     For this reason corneal temperature can be used as a surrogate to quantify ocular blood~     flow. It can be measured by means of infrared thermography. This test, however, is not used~     in an everyday clinical routine so far. In this study is investigated if ocular blood flow~     disturbances in glaucoma patients can be diagnosed by means of infrared thermography.~      Corneal temperature are measured in normal tension glaucoma patients and healthy controls~     before and after cold provocation test. In the group of patients and the group of controls,~     subjects with and without a primary vascular dysregulation (PVD) are included. This will~     allow to analyze and compare the influence of cold provocation on corneal temperature (and~     indirectly ocular blood flow) in these study Groups.~   "
29267|NCT02674061|"~     This study will assess the efficacy and safety of pembrolizumab (MK-3475) in women with~     advanced ovarian cancer who have demonstrated recurrent disease following the front line~     platinum-based treatment and debulking surgery and received up to 5 lines of treatment for~     recurrent ovarian cancer (ROC) per local standard of care. Participants will receive~     pembrolizumab every 3 weeks (Q3W) for up to 2 years.~   "
29268|NCT02674048|"~     Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to~     evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate~     actinic keratosis of the face/scalp and to assess physician and patient satisfaction.~   "
29269|NCT02674035|"~     Thirty women with similar abdominal deformities, who had had at least one pregnancy, were~     randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus~     sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in~     a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a~     continuous barbed suture (group II). Operative time was recorded. All patients underwent~     ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor~     for diastasis recurrence. The force required to bring the anterior rectus sheath to the~     midline was measured at the supraumbilical and infraumbilical levels.~   "
29270|NCT02674022|"~     The purpose of this research study is to screen for metabolic abnormalities that are~     maternal risk factors for having a child with autism.~   "
29274|NCT02673970|"~     1. Screen and recruitment: patients will be screened based on their prior history and~          intention to initiate treatment with an immune checkpoint inhibitor.~        2. Study phase:~             -  Collection of baseline demographic data, prior disease history, nature of ICI~               therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor~               response and survival).~             -  Collection of blood samples will be performed every 3 to 4 weeks for the first~               year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI~               therapy, disease progression, death or loss to follow-up. Collection of blood~               samples will be aligned with the visits necessary for the administration of the~               ICI therapy.~             -  Collection of archival melanoma metastasis tissues will be performed on a~               continuous basis and be triggered by availability of such tissue following~               therapeutic resections of melanoma metastases.~        3. Follow-up phase~   "
29275|NCT02673957|"~     This study aims to analyze the way the human body responds to a temporary lack of oxygen, or~     ischaemia. Prospective participants will complete a health screen to confirm overall health~     / low cardiovascular risk profile.The participants will be required to have pneumatic blood~     pressure cuff inflation to 200mmHg on the upper arm for 5 minutes which will then be~     deflated for 5 minutes and then repeating the cycle of inflation and deflation a further 3~     times. Blood tests from veins in the forearm would be taken before, during, and after this~     is done in order to compare results and establish any change in concentration of local and~     circulating compounds.~   "
29276|NCT02673944|"~     A comparative study will be conducted and the patient will undergo a conventional urodynamic~     study. In order to successfully determine if the Peritron+ is capturing vesical pressure~     measurements consistent with conventional urodynamics the two sources of Pves will be~     collected concurrently.~   "
29277|NCT02673931|"~     Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain~     and kidneys.~      This study is designed as a 2-by-2 randomized clinical trial with the purpose of~     investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist~     Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from~     cardio-pulmonary bypass.~   "
29278|NCT02673918|"~     The investigators have developed an online rehabilitation platform to guide women in their~     home-based upper-body exercises after breast cancer surgery. The platform includes~     rehabilitation videos that will guide the women in performing home-based early post-surgery~     upper-body rehabilitation tailored for each individual.~      The primary objective is to assess the feasibility and acceptability of a home-based~     rehabilitation program supported by a supplemental online platform for women after breast~     cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of~     the platform will be tested in 11 municipalities in Denmark.~   "
29279|NCT02673905|"~     The purpose of this study is to investigate the efficacy of an engineered cartilage~     transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of~     articular cartilage lesions in the knee. The main innovations in this trial are the use of~     nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix.~     The goals of the trial are to: (i) evaluate whether implantation of a more mature graft~     (tissue therapy) is beneficial for the quality and durability of the repair tissue and the~     clinical outcome, (ii)determine the potential of the mature graft to integrate with the~     adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each~     treatment in correlation to the characteristics of the defect (e.g. acute versus chronic~     setting).~   "
29280|NCT02673892|"~     Improving the patient experience has become a major focus of quality improvement efforts in~     Ontario and in health systems worldwide. However, our existing knowledge base is relatively~     under-developed, particularly in how patients experience care as they transition from one~     care setting to another and the relationship between patient experience and clinical~     outcomes. The Patient Oriented Discharge Summary (PODS) is a discharge instruction tool~     created by patients, caregivers, health-care providers and design experts. It provides a~     written template for providers to engage patients and caregivers when reviewing important~     instructions on medications, activity and diet restrictions, follow-up appointments and~     worrisome symptoms warranting emergency care following admission to hospital. The PODS also~     uses plain and simple wording, large fonts, pictograms, and includes white space for~     patients to take notes and provides the option for translation of major headings into the~     most common spoken languages. The PODS impact study will study the impact of using the PODS~     versus usual discharge instructions on patient experience and health outcomes in a~     provincial-wide randomized study across acute care and rehabilitation hospitals.~   "
29281|NCT02673879|"~     The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the~     effectiveness and safety of complete percutaneous pericardial drainage facilitated by~     intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to~     conventional pericardiocentesis when indicated in 2176 patients with large pericardial~     effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218~     patients will initially confirm the feasibility of conducting a large-scale multi-centre~     clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion,~     and also provide preliminary safety data, following a dose finding study of intrapericardial~     alteplase.~   "
29282|NCT02673866|"~     The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will~     demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will~     be generally well tolerated.~   "
29283|NCT02673853|"~     This study aims to establish the incidence of residual paralysis in patients following~     administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in~     most patients) during supraglottic airway insertion and correlate it with the duration of~     time from drug administration to arrival at PACU. The secondary aim is to compare the~     incidence of residual paralysis in patients who receive full doses of atracurium (per body~     weight) with those who receive mini-doses.~   "
29348|NCT02672995|"~     The investigators propose a new treatment strategy of fractionated stereotactic radiosurgery~     with concurrent bevacizumab for brain metastases. This phase I dose-escalation study is to~     establish the feasibility of this strategy and find the recommended doses.~   "
29284|NCT02673840|"~     Rationale and Aims: Infection by dengue virus (DENV) causes major morbidity and mortality~     throughout the world. In 2012, an estimated 3.6 billion people live in areas at risk for~     DENV infection, including Singapore. The key pathology of DENV infection is vascular~     leakage, which can occur in mild cases and can become life-threatening in severe cases when~     patients may develop dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS). Mast~     cells (MCs) are strongly activated by DENV with preliminary studies showing that activation~     levels are correlated to disease severity in human patients. Thus, the investigators propose~     to use the MC stabilizing drug, ketotifen, to limit the immune pathology that is~     characteristic of dengue infection and treat dengue-induced vascular leakage. Methods: The~     ability of Ketotifen to reduce vascular leakage in DENV patients will be determined by~     assessing the pooling of fluid in the pleural cavity (measured by MRI and CXR) after 5 days~     of drug administration, evaluated as a percent change compared to baseline fluid levels.~     Additional measures of vascular leakage and immune pathology will be compared as secondary~     objectives. The trial will be conducted as a randomized, double-blind study comparing the~     responses of dengue patients given either ketotifen or placebo (n=55 per arm). Importance of~     proposed research: Currently, no targeted treatments exist to limit vascular leakage during~     DENV infection. If Ketotifen is identified as effective for preventing pleural effusion~     and/or plasma leakage in DENV patients, this would constitute an advance for the clinical~     management of DENV fever. This finding would also support a large-scale trial to determine~     whether Ketotifen can be used to prevent severe vascular leakage as occurs during DHF/DSS.~     Benefits/Risks: Ketotifen has a record of safety and tolerability in humans, regulatory~     approval, and widespread use. Side effects are generally mild. The potential exists that, if~     effective, many of the painful and life-threatening symptoms of DENV infection that result~     from plasma leakage would be improved.~   "
29285|NCT02673827|"~     Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on~     stress and depression levels of individuals with multiple sclerosis.~   "
29286|NCT02673814|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to durvalumab will improve the results of the treatment for~     non-small-cell lung cancer.~   "
29287|NCT02673801|"~     The purpose of the study is to evaluate an algorithm to screen patients with suspected knee~     osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and~     patient-reported symptoms. It will be investigated whether the algorithm is able to identify~     which patients that are deemed relevant to undergo an orthopedic assessment. This will be~     evaluated by estimating the sensitivity of the new algorithm compared to with the~     traditional clinical assessment of the patients.~   "
29288|NCT02673788|"~     This is a follow-up study of the open label, single-center, phase I clinical trial to~     evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.~   "
29289|NCT02673775|"~     The purpose of the study is to better understand the mechanisms of lung injury from ozone~     exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm~     ozone. Subjects will be asked to produce sputum through coughing after each exposure. The~     samples will be analyzed for macrophage activity.~   "
29290|NCT02673762|"~     A PRoBE design study will be used to obtain saliva from patients before undergoing blood~     study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes~     of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with~     multi-marker models for their discriminatory value for distinguishing patients with normal~     glucose metabolism from those with disease. Appropriate housekeeping genes will also be~     incorporated to allow for the measurement of relative gene expression.~   "
29291|NCT02673749|"~     RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its~     potential to improve the tolerance of lactose (dairy products).~   "
29292|NCT02673736|"~     The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary~     efficacy of the investigational drug PLX73086 in subjects with solid tumors including~     subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).~   "
29293|NCT02673723|"~     Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to~     find a safe and effective method for intubation. Awake tracheal intubation which is used to~     retain spontaneous breathing is one of the important measures to ensure the safety of the~     patients with difficult airway in anesthesia.~      Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of~     awake tracheal intubation, however, the outstanding problem is serious respiratory~     depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa~     opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced~     cough during general anesthesia induction.It is necessary to carry out large-scale,~     multi-center, randomized, controlled clinical study to determine whether dezocine prevents~     sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe~     and effective method for awake tracheal intubation.~   "
29294|NCT02673710|"~     The purpose of this study is to explore the relationship between sarcopenia, as defined by~     computed tomography, treatment related outcomes and other body composition related~     parameters in a patient population receiving bevacizumab beyond progression.~   "
29295|NCT02673697|"~     Prospective, randomized, stratified non blinded multi-center, international, post market~     trial assessed in a non-inferiority study.~      A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational~     sites where the device is commercially available.~      The primary objective of this trial is to test the safety and efficacy of Perceval versus~     standard sutured stented bioprosthetic aortic valves among the intended trial population.~   "
29296|NCT02673684|"~     The purpose of this study is to evaluate the ability of Neuro-Stim System, a~     non-pharmacologic alternative for pain management, to reduce pain and treat insomnia.~     Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the~     ear and possibly the autonomic nervous system.~   "
29297|NCT02673671|"~     A feasibility study for assessing and recording myoelectric activity in patients for early~     detection of a post-operative ileus (POI) in patients who undergo gastrointestinal surgery~     and differentiating the myoelectric signals from those who have normal post-operative return~     of GI function.~   "
29298|NCT02673658|"~     The purpose of this longitudinal study is to examine the ongoing interaction between the~     domains of cognitive and motor development in infants with neuromotor disability, and to~     compare outcomes of two groups of infants receiving two different types of home-based,~     parent-delivered physical therapy intervention, in order to determine which intervention is~     more effective in advancing cognitive as well as motor development. Knowledge of the~     effectiveness of two types of intervention will lead to improved early intervention for~     children with developmental disabilities, as well as future studies to examine ongoing~     outcomes.~   "
29301|NCT02673619|"~     Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is~     anticipated that topical administration of UMEC will block stimulation of muscarinic~     receptors, thereby reducing the overproduction of sweat in subjects who suffer from~     hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and~     tolerability of topically applied UMEC following once daily topical administration, for 28~     days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also~     investigate if topically applied UMEC, at the highest possible concentration, will decrease~     palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or~     below that observed with inhaled administration. This is a double blind (Sponsor unblind),~     repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55~     subjects.~   "
29302|NCT02673606|"~     The goal of this project is to examine how estrogen may influence the resting-state~     connectivity and the extinction-induced activation of the fear extinction network.~   "
29303|NCT02673593|"~     The purpose of the study is to investigate the safety, pharmacokinetics and food effect of~     DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.~      DS102 capsules will be orally administered for up to 4 weeks, and will be compared against~     placebo.~      The study will enrol approximately 56 adult subjects.~   "
29304|NCT02673580|"~     The aim of this study is to compare quality of care and patient experiences in two~     outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and~     2) Open Access telePRO (patient-initiated telePRO follow-up)~   "
29305|NCT02673567|"~     This is a single center, randomized, double-blind, placebo-controlled study to assess the~     pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125~     (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy~     subjects.~   "
29306|NCT02673554|"~     In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic~     polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus~     bolus administration. The design was a two-way crossover design comparing repeated bolus~     injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients~     were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such~     patients, and healthy subjects. Investigators performed a:~        1. Oral glucose challenge;~        2. hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50~          pmol/kg body weight at 30 and 120 min); and~        3. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from~          30-180 min).~      To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic~     action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives,~     and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90~     min apart, and compared this to a continued intravenous infusion of GIP.~   "
29307|NCT02673541|"~     The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™~     stent versus the conventional approach using double pigtail plastic stents in the~     treatment of patients with walled-off pancreatic necrosis.~   "
29308|NCT02673528|"~     Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall~     incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical~     removal of the inflamed appendix by using open or laparoscopic appendectomy.~      Following laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the~     corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional~     approach to LA uses three ports. Over the past decade, successful attempts to perform the~     procedure with fewer ports have been reported.~      The authors' primary objectives were to 1) identify a simple, safe and feasible way to~     perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2)~     determine the health related quality of life of the patients and calculate the cost per~     quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a~     surgical algorithm when approaching to acute appendicitis with the consideration of quality~     of health and cost.~   "
29309|NCT02673515|"~     InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study~     participants will be healthy subjects and subjects who already practice Alternate Day~     Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting~     group and 50 participants in the control group). Those participants in the control group~     will be asked to participate in a short randomized controlled trial, where they will be~     either allocated to an Alternative Day Fasting group or another control visit.~   "
29310|NCT02673502|"~     Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based~     interventions delivered throughout the peri-operative period that aim to attenuate the~     surgical stress response and support rapid physiologic and functional recovery.A key element~     of the ERAS pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before~     surgery in order to keep the patient in a fed state rather than a fasted state when they go~     to the operating room. The aim of the current study is to investigate the impact of a drink~     containing simple carbohydrate on attenuating surgical stress induced insulin resistance in~     patients undergoing major laparoscopic abdominal surgery, compared to drinks containing~     maltodextrin.~   "
29311|NCT02673489|"~     The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir~     with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected~     patients with liver cirrhosis.~   "
29312|NCT02673476|"~     This study is being to see how effective and safe ALS-008176 is in treating adults in the~     hospital with a Respiratory Syncytial Virus-Related Illness.~   "
29313|NCT02673463|"~     This study aims to assess whether treatment with a drug called spironolactone, which is an~     aldosterone inhibitor, can improve ability to cope with exertion, quality of life and~     ability of the heart to relax better in symptomatic patients with atrial fibrillation with~     preserved pumping capacity.~   "
29314|NCT02673450|"~     This study investigates a possible relationship between disturbance of the cyclic expression~     of ten different clock genes and development of delirium in patients admitted to an~     intensive care unit~      It also investigates a possible relationship between disturbance of the cyclic expression of~     melatonin and development of delirium in patients admitted to an intensive care unit.~      Finally a possible relationship between genetic differences in the PER3 gene and development~     of delirium is investigated.~   "
29315|NCT02673437|"~     Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary~     syndrome (ACS) comprises a range of disorders, including heart attack and unstable angina,~     caused by a sudden reduction in blood flow to part of the heart muscle. This study aims to~     collect information on the use of rivaroxaban and its safety when used by patients for the~     prevention of atherothrombotic (plaque rupture leading to a blood clot) events following~     ACS, during the first three months after starting. This study was requested by the European~     regulatory body (EMA) which is responsible for the use and safety of medicines. It will last~     for approximately 3 years and is a national study covering the whole of England and Wales.~     The study aims to recruit 1193 patients who have been prescribed rivaroxaban and~     antiplatelet therapy and 1193 patients who have been prescribed alternative dual~     antiplatelet therapy for the secondary prevention of atherothrombotic events following ACS.~     Each patient will only be monitored for the first 13 weeks after hospital admission for ACS.~     Patients who choose to take part will complete a consent form. The patient's care team will~     be asked to complete a baseline questionnaire about the patient at the time the medicine is~     given and a further questionnaire up to 16 weeks later, specifically asking about the~     patient's experiences whilst on the medication. If anything unusual is reported during the~     observation period, the care team may be asked to fill out a followup questionnaire. With~     the patient's consent, the study team will also inform the patient's General Practitioner~     (GP) of their participation in the study and will ask the GP to complete an abridged~     questionnaire from the patient's medical records. The study team will analyse and aggregate~     the data, carefully protecting patient confidentiality, to classify adverse events of~     interest, in particular bleeding events.~   "
29316|NCT02673424|"~     To compare the safety and efficacy of physiology (fractional flow reserve [FFR])-guided~     percutaneous coronary intervention (PCI) strategy with imaging (intravascular ultrasound~     [IVUS])-guided PCI in patients with intermediate coronary stenosis.~   "
29317|NCT02673411|"~     The purpose of this study is to measure diagnostic performance of ultrasound shear wave~     elastography to detect advanced hepatic fibrosis.~   "
29318|NCT02673398|"~     This phase II trial studies the side effects of and how well neratinib works in treating~     older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer~     that has spread from where it started to other places in the body (metastatic). Neratinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
29319|NCT02673385|"~     In France, the last national perinatal survey show that 6.6% of live births are premature.~     For these infants, transfer in Neonatology sector may result in mother-child separation can~     last several weeks or months. This hospital can complicate the implementation of the~     attachment process that allows parents to recognize their children as their own, to gain~     confidence in their abilities to deal with them and establish a relationship with him.~      A study of mothers of premature shows the interest of the Brazelton scale to help them~     identify the skills their child and adjust their own behavior.~   "
29320|NCT02673372|"~     This research project is geared towards geriatric analgesia in the Emergency Department (ED)~     with a goal of reducing the administration of opioid pain medications to elderly patients,~     thereby avoiding the commonly occurring, severe side effects associated with such~     medications, including hypotension, respiratory depression, altered mental status, delirium,~     as well as nausea/vomiting and constipation.~      The primary outcome of the study will be difference in pain score from baseline to 30~     minutes post-medication administration. The secondary outcomes will be the need for rescue~     analgesia and the incidence of adverse side effects and patients' satisfaction with low-dose~     ketamine or low dose morphine analgesia in managing their painful conditions in the ED.~      This project has the potential to change and modify the ED approach to geriatric analgesia~     by virtue of minimizing the use of opioid administration in elderly patients. T~   "
29321|NCT02673359|"~     The aim of this study to compare vaginal progesterone supplementation to cervical cerclage~     for prevention of preterm labor in women with short cervical length and history of previous~     midtrimester miscarriage and/or preterm labor.~   "
29322|NCT02673346|"~     The aims of this study are 1) To assess the prevalence of tobacco use and cessation~     treatment preferences among YKHC employees, 2) To assess employee's current levels of~     perceived stress, engagement in physical activity, and feelings of resiliency to inform~     future tobacco cessation interventions, and to examine the relationship between these~     factors and tobacco use, and 3) To assess YKHC employees' perceptions and opinions of the~     hospital's current workplace tobacco policy and expansion of these regulations to all YKHC~     properties.~   "
29323|NCT02673333|"~     Pembrolizumab is a type of immunotherapy, and the purpose of this study is to find out what~     effects, good and/or bad, pembrolizumab has on you, and your cancer.~   "
29324|NCT02673320|"~     The studied pathology concerns post traumatic cervical spinal cord contusion on narrow~     spinal canal.~      The pathophysiology remains controversial. This pathology does not enjoy consensus support.~     Many questions remain regarding the surgical care and its delay.~      The purpose of the study was to demonstrate non-inferiority of early surgical treatment~     compared to the same surgery performed with a delay among patients identified as having a~     cervical spinal cord contusion on posttraumatic narrowed cervical canal.~      In the current state of knowledge and practices, the treatment of post traumatic spinal cord~     contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The~     generally accepted delay is 15 days.~      The surgical technique is a conventional cervical spinal decompression surgery. The type of~     decompression (anterior or posterior) is dependent on the compression and therefore the~     clinical radiological analysis. The choice of the technique and the surgical approach are~     therefore left to the discretion of the surgeon.~      After completion of the clinical and radiological diagnosis of post-traumatic spinal cord~     contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the~     Neurosurgery Service of the University Hospital concerned.~      After anesthetic consultation determining the feasibility or not of surgery and in the~     absence of other vital injury or involving life-threatening, early surgery within 48 hours~     of diagnosis is then considered (according to the assigned group).~      The surgical technique is a conventional cervical spinal decompression surgery. Way~     posterior surgery, laminectomy for spinal stenosis significant if greater than or equal to 3~     floors will be preferred. In other cases, the type of surgery will be at the discretion of~     the surgeon and the opinion of the Staff Neurosurgery.~      The surgical procedure is identical in the two groups. Alone, the delay of the surgery~     varies : less than 48 hours for the first group and 15 days for the second.~      During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following~     criteria will be assessed : the quality and quickness of the motor and sensory recovery, the~     early post-operative evolution and the long and medium term evolution but also disability~     and functional sequelaes.~   "
29325|NCT02673307|"~     The aims of this prospective cross over study was to compare the gastric emptying of 250 ml~     water in fasting volunteers, in two situations : without chewing gum or while chewing gum~     during 45 min~   "
29349|NCT02672982|"~     The overall objective of the research is to assess the long-term and cost-effectiveness of a~     combined nutrition psychosocial intervention to a stand-alone nutritional treatment of~     children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of~     Nepal.~   "
29350|NCT02672969|"~     This study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and~     bio-aerosols particles in operating rooms at a university hospital, Thailand.~   "
29351|NCT02672956|"~     Investigators selected participants who operated by laparoscopic technique due to any~     gynecologic indication according to random number table. The ten mm trocar was inserted~     supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of~     patients. One month after we evaluated umbilical scar by used vancouver scar scale and~     compared results of vancouver scar scale.~   "
29326|NCT02673294|"~     The level of stroke chronicity has been proposed as an influential variable related to~     functional balance. However, little is known about the effect of this variable on the~     effectiveness and maintenance of gains of physical therapy interventions on balance. The~     objective of this study is to determine the influence of time since injury on the~     rehabilitation of balance after stroke. Participants will be assigned to a least (6-12~     months), a moderate (12-24 months), or a most chronic (> 24 months) group. All the~     participants will train for 20 one-hour sessions, administered three to five times a week,~     combining conventional physical therapy exercises and customized exercises interfaced on a~     balance board that promotes the training of the ankle and hip strategies. Participants will~     be assessed before, after the intervention, and one month later with a posturography test~     (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional~     Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test,~     Timed Up-and-Go Test, and the 10-meter Walking Test).~   "
29327|NCT02673281|"~     The purposes of the study are:~        -  Study Aim 1. To assess the mechanisms underlying the biological effects of short-term~          walnut consumption on appetite with functional magnetic resonance imaging (fMRI) and~          assessing neurocognitive function/memory~        -  Study Aim 2. To investigate the effects of walnut consumption (48g per day over 5 days)~          on appetite and satiety by analyzing molecules which regulate energy homeostasis such~          as adipokines, as well as resting metabolic rate which measures energy expenditure.~        -  Study Aim 3. To investigate the effects of walnuts (48g per day over 5 days) on insulin~          resistance, lipids, and inflammatory markers in obesity as well as the effect of~          walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion~          and the excretion of gut peptides and free fatty acids.~   "
29328|NCT02673268|"~     The objective of this study is to demonstrate the feasibility of a mastectomy with~     conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate~     breast reconstruction using prosthesis.~      The interest is to avoid scars on the breast. The scars are limited to the armpit and under~     the arm.~      The aim is also to study the rate of complications, cosmetic results and quality of life.~   "
29329|NCT02673255|"~     Many plasma donation centers have Tetanus immunization programs that are implemented in~     order to collect plasma with high levels of tetanus antibodies. The immunization program~     requires participants to receive multiple tetanus vaccinations over a period of time with~     the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to~     manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment~     of tetanus disease.~      The Tetanus vaccine previously used for these programs is no longer being manufactured.~     Therefore, we must evaluate the safety and efficacy of a different vaccine when used for~     this purpose. The only other FDA approved Tetanus vaccines currently available for adults in~     the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.~      In this study, the investigators will evaluate two vaccines that are combinations of Tetanus~     and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis~     antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur~     (Tenivac).~      The package insert for these vaccines indicates they should be administered to previously~     vaccinated people once every 10 years. However, this study will evaluate whether they are~     safe and effective for dosing every 90 days.~      The investigators hypothesize that at least 25% of study subjects will have a positive~     response to at least one of the five planned doses. Each vaccine will be evaluated~     separately.~   "
29330|NCT02673242|"~     This study is a randomized controlled trial with the aim of evaluating the effect of~     homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The~     intervention group will train with threshold IMT for 6 weeks. The control group will not~     participate in any other training method or sham. Evaluation parameters are maximal~     inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research~     council dyspnea scale and spirometry.~   "
29331|NCT02673229|"~     By doing this study, researchers hope to learn if applying Santyl to the burn during the~     healing process affects the appearance of the resulting scar.~   "
29332|NCT02673216|"~     Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse~     out-come of pregnancy and a significant proportion is caused by infection. The investigators~     aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of~     gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously.~     Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV)~     subclasses, to vaginal fluid inflammation markers, and to the presence of novel~     Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative~     PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on~     selected specimens with the aim to identify markers allowing for a personalised treatment~     approach.~   "
29333|NCT02673203|"~     To investigate whether the daily glucose profiles as assessed by continuous glucose~     monitoring for 1 week of normal weight, obese, and diabetic individuals relate to hunger~     levels and food intake.~   "
29334|NCT02673177|"~     This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total~     mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter-~     preservation outcomes for low rectal cancer.~   "
29335|NCT02673164|"~     The aim of the SCIENCE study is, in an international multicentre double-blind~     placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of~     100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in~     patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.~   "
29352|NCT02672943|"~     In this three-year project, our research teams are going to consecutively explore these~     important clinical, drug and physical rehabilitation treatment effects, noradrenergic~     network, autonomic dysfunction and microRNA signalling data as well as the correlations~     between them in early Parkinson Disease (PD) patients. The investigators hypothesize that~     the explorations of the above insights are unique and can provide an important source data~     for Taiwanese Parkinson Disease (PD).~   "
29385|NCT02672514|"~     The aim of this study was to prospectively evaluate MECC compared with conventional~     extracorporeal circulation of diabetic patients undergoing elective coronary~     revascularization procedures. The investigators focused on the effects of extracorporeal~     circulation especially the renal function between both groups.~   "
29336|NCT02673151|"~     This trial studies how well gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC~     (68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting~     prostate cancer that may have come back in patients with elevated prostate-specific antigen~     (PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate,~     after treatment with surgery or radiation in patients without symptoms indicates that the~     cancer may have come back (recurrence). PSA however cannot determine whether the disease is~     located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer~     that targets and specifically binds to tumor cells expressing PSA making them lighting up.~     PET and CT make computerizing pictures of areas inside the body where the radioactive~     substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard~     imaging and may help determine whether prostate cancer has come back and where it is in the~     body.~   "
29337|NCT02673138|"~     This study will be an open-label, cross-over study as subjects will be studied under both~     study conditions - suspension of subcutaneous insulin infusion via pump during treatment~     with insulin alone (control) vs. suspension of subcutaneous insulin via pump during~     treatment with insulin and canagliflozin.~   "
29338|NCT02673125|"~     Chromosomal abnormalities are a major cause of pregnancy loss. Preimplantation Genetic~     Screening (PGS) using Next Generation Sequencing (NGS) allows the effective detection of~     these abnormalities and improves clinical outcomes. However even the transfer of a~     chromosomally normal embryo does not guarantee successful implantation. Recent research by~     Fragouli, et. al. 2015 has demonstrated a strong association between mitochondrial DNA~     quantities (also known as MitoGradeTM) and implantation outcomes in embryos that are already~     classified by PGS as chromosomally normal. Investigators have also demonstrated in a~     clinical study that MitoGradeTM normal and PGS normal embryos have higher chances of~     implantation than MitoGrade elevated PGS normal embryos. Transferring MitoGrade elevated PGS~     normal embryos results in less than 10% implantation rates while MitoGrade normal PGS normal~     embryos resulted in more than 65% implantation rates. The risk of miscarriage after~     replacing either type is very low (about 8%).~      In order to understand the complete effectiveness of the test, investigators are conducting~     a paired prospective study. This means that investigators will be transferring a MitoGrade~     normal and a MitoGrade elevated embryo at the same time to see if one implants better than~     the other. It is expected that patients joining this study will benefit from knowing that at~     least one embryo is MitoGrade normal PGS normal.~   "
29339|NCT02673112|"~     To compare the efficacy of a sub-threshold aerobic exercise intervention provided with~     mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18~     yo youth with persistent concussion symptoms.~   "
29340|NCT02673099|"~     Introduction: Patients with end stage renal disease are exposed to metabolic and hemodynamic~     complications due to the disease itself and as a result of the dialysis treatment related~     complications. Uremic toxins due to their middle molecular weight are not effectively~     removed during Hemodialysis. Their accumulation leads to chronic oxidative stress and~     chronic inflammation state associated with increased morbidity and mortality. In addition,~     during each dialysis session oxidative stress (OS) and inflammation are provoked once blood~     interacts with the dialyzer.~      In recent years the use of Online Hemodiafiltration (OL- HDF) has entered in order to enable~     better uremic toxins clearance. This a relatively new method of therapy that allows a larger~     volume of blood filtration during a single dialysis therapy compared with standard~     hemodialysis. It combines diffusion with convection to clear middle molecular weight~     substances more effectively compared with Hemodialysis. This method was found to reduce~     rates of cardiovascular morbidity and mortality among dialysis patients.~   "
29341|NCT02673086|"~     The primary aim of this study is to compare needle tip visibility between the coracoid~     approach and retroclavicular approach for infraclavicular brachial plexus block in patients~     undergoing elective upper limb surgery. Secondary aim is to investigate the differences~     between the two groups in the needle shaft visibility, sensorial block success rate, block~     performance time, block performance related pain, motor block success rate, surgical success~     rate, complications, patient satisfaction, use of supplemental local anesthetic, use of~     analgesic.~   "
29342|NCT02673073|"~     Before a HF patient gets maximally decompensated and visit emergency department, most~     patients experience symptoms and signs of on-going decompensation (or pre-decompensation),~     which may not be noticed by the patients. If HF patients were aware of symptoms and signs of~     ADHF and received early intervention to stop the process of on-going decompensation (or~     pre-decompensation), it would be possible to reduce the rate of hospitalization for ADHF or~     death. Thus, self-awareness and self-examination of heart failure symptoms, signs and~     medical compliance using a patient diary in HF management may improve the outcomes in~     chronic stable HF patients. A patient diary with 6 parameters can serve this purpose: body~     weight, blood pressure, heart rate, drug compliance expressed as number of remaining pills~     of previous day, edema grade, and dyspnea grade.~   "
29343|NCT02673060|"~     This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a~     cytostatic agent [ara-C] in patients with malignant tumors with CIBD. This is a first use in~     human.~   "
29344|NCT02673047|"~     This study will describe the prescription conditions of botulinum toxin Type A (Botox®)~     injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity~     (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice~     in France.~   "
29345|NCT02673034|"~     The aim of the study is to investigate the circadian variation in serum-progesterone in~     women undergoing controlled ovarian stimulation.~   "
29346|NCT02673021|"~     Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?~   "
29347|NCT02673008|"~     Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute~     leukemia, but relapse remains an important problem. Therapy options for relapse include~     stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI),~     and another transplantation used alone or in combination. However, the efﬁcacy of these~     interventions is limited. One approach to the relapse problem is to intervene before~     hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this~     study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in~     patients with acute leukemia receiving allo-HSCT.~   "
29353|NCT02672930|"~     Hyperkalemia is a common problem in the emergency services and one of the life threatening~     metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics,~     sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially,~     avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured~     electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the~     literature. So the aim of this study was to evaluate administration of iv calcium efficiency~     on vital signs and ECG.~   "
29354|NCT02672917|"~     Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9~     Positive Malignancies.~   "
29355|NCT02672904|"~     comparison results of treatment of early stage glottic cancer between two methods of~     surgical treatment - CO2 laser and KTP laser~   "
29356|NCT02672891|"~     Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics~     emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for~     the management of postpartum hemorrhage involve a stepwise approach including the exclusion~     of retained products and genital tract trauma. Uterine atony, which is the most common~     cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities~     introduced to arrest the bleeding is the uterine tamponade using various balloons and~     catheters. The condom catheter uses a sterile rubber catheter fitted with a condom for~     uterine tamponade .~   "
29357|NCT02672878|"~     Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will~     assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the~     treatment of patients suffering from ISR.~   "
29358|NCT02672865|"~     The purpose of this study is to determine safety and tolerability of adjuvant hyperthermic~     intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in subjects with locally~     advanced gastric cancer undergoing standard surgical resection. Subjects will be treated~     with HIPEC using a single dose each of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C~     for 90 minutes, during the definitive surgical procedure for gastric cancer. HIPEC will be~     performed after resection but before anastomosis.~   "
29359|NCT02672852|"~     This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week~     study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy~     and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment~     of moderate to severe chronic plaque psoriasis in adult patients. This study will also look~     at the maintenance of response following randomly withdrawing treatment from those patients~     responding to treatment at week 28, as well as the response to re-treatment for patients who~     relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the~     influence of study treatment on disease specific markers. In a subset of psoriasis patients~     with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be~     evaluated to assess improvement.~   "
29360|NCT02672839|"~     The purpose of this study is to compare relative oral bioavailability of a capsule~     formulation of LGD-6972 to a solution formulation of LGD-6972.~   "
29361|NCT02672826|"~     The endothelium is a key barrier between blood and tissue compartments. It is a major target~     of factors involved in metabolic and cardiovascular pathologies. However, the study of~     native human adult endothelial cells is difficult due to the lack of appropriate models and~     thereafter the endothelium is actually not easily accessible for clinical investigation.~     However, our results recently showed that the endothelium from human adipose tissue exhibit~     distinct phenotypes, including endothelial cell number and inflammatory, angiogenic and~     senescent state, according to adipose tissue location, i.e. subcutaneous and visceral. It is~     well recognized that estrogens favour gluteo-femoral adipose tissue deposit and their~     deficit after menopause is associated with increased abdominal and visceral fat mass as well~     as metabolic dysfunctions. These perturbations might be prevented with hormonal therapy.~     However, no data are available concerning the endothelial cells from gluteo-femoral and~     abdominal adipose tissues in women.~   "
29362|NCT02672813|"~     The primary objective of this study is to access the effect of Pectoral nerve I and II~     blocks in breast surgery as measured by consumption of postoperative morphine or its~     equivalent.~   "
29363|NCT02672800|"~     The purpose of this study is to evaluate the feasibility and acceptability of a writing~     intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal~     caregivers whose partners died with dementia.~   "
29364|NCT02672787|"~     Despite great strides, hypertension remains an incredibly important disease and public~     health problem. This study addresses this critical need among ED patients, a unique~     population of patients who are (a) likely to benefit from an antihypertensive adherence~     intervention due to their high prevalence of uncontrolled blood pressure and poor adherence,~     and (b) at high risk for poor cardiovascular outcomes. The protocol provides for a~     multicomponent intervention bundle to be tested among ED patients. Successful clinic-based~     behavioral interventions generally target a combination of barriers to adherence; bundled~     interventions have shown success in a wide range of settings and diseases. In some cases,~     bundled components were necessary to achieve blood pressure benefit in a primary care~     setting; isolated educational efforts have had mixed success in the ED.~   "
29372|NCT02672683|"~     The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs~     in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that~     expression of these microRNAs could discriminate patients with a histologically proven~     rejection from patient displaying a normal endomyocardial biopsy. The signature must be~     confirmed in unselected patients and its stability evaluated according to clinical,~     biological and immunological parameters of included patients.~   "
29384|NCT02672527|"~     As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data~     regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in~     soft tissue sarcoma remain to be assessed.~      For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival~     data for patients with advanced or metastatic STS are of poor prognosis despite improvement~     of results this last years. For example, median overall survival increased from 12,3 months~     (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).~      Considering the latest results with and without Trabectedin, the investigators may consider~     that comparing Trabectedin with best supportive care is ethically acceptable as long as~     patients consent to enter the trial.~   "
29365|NCT02672774|"~     The aim of the project is to study the role of minimally invasive imaging methods, such as~     magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser~     endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the~     angiogenesis status of patients with gastrointestinal tumors, in particular with colorectal~     and gastric cancer. Angiogenesis, i.e. the process of forming new blood vessels, represents~     an essential event for tumor growth and metastasis and the importance of its understanding~     stems from potential applications for diagnosis, prognosis stratification and mainly from~     the possibility of developing and improving targeted therapies. While current methods for~     evaluating tumor vascularity are based on immunohistochemistry techniques with microvascular~     density (MVD) calculations, these imply repeated tissue sampling and are not feasible in the~     context of clinical practice. Imaging techniques might overcome limitations associated with~     MDV measuring, obtaining both functional and morphological information and enabling repeated~     evaluations that are necessary for the assessment of a dynamic process as angiogenesis~     during follow-up of targeted therapies.~      NBI is a digitally enhanced endoscopic imaging technique that uses optical filters to~     illuminate tissue with light at blue and green wavelengths. These are selectively absorbed~     by hemoglobin and, as a result superficial vascular networks are highlighted and~     morphological changes in capillary patterns can be described for different lesions. CLE~     represents a revolutionary technology that enables endoscopists to collect real-time in vivo~     histological images or virtual biopsies of the gastrointestinal mucosa during endoscopy,~     and has raised significant interest for the potential clinical applications and numerous~     research possibilities. After intravenous administration of fluorescein as a contrast agent,~     CLE enables real-time visualization of the tumor vasculature, which is structurally and~     functionally altered compared to the normal vascular networks. Therefore M-NBI will be used~     for enhanced visualization of morphological changes of the superficial capillaries, while~     CLE will be directed towards vascular regions of interest for characterization of these~     changes at the microscopic level. Furthermore, imaging studies will be backed by MVD~     calculation using immunohistochemical methods, based on tissue samples harvested during~     endoscopic procedures.~   "
29366|NCT02672761|"~     Meditation improves attention and memory by reducing of the increased electric brain~     activity induced by a high stress level. This is associated to neuroplastic changes (volume~     reduction and/or neuron's density increases) in various brain structures. The question~     evolves if memory improvement by a standardized meditation program of 8 weeks (Mindfulness~     Based Stress Reduction MBSR) or a specific memory training (My Brain Training MBT) is a~     specific effect on brain networking or mediated by a reduced general activity induced by~     stress reduction. Thus, meditation or memory training should have differing neuroplastic~     effects.~      The effects of memory function improvement by the respective training will be measured by~     MAT, a specific and validated computerized memory and attention test. Brain morphology is~     investigated by voxel based morphometry NMR before and immediately after an 8 weeks~     intervention period. Stress levels are measured by cortisol profiles of subjects. Compared~     were 4 groups- MBSR group- MBSR students after completed training, passive control~     group- subjects following an 8 weeks waiting period for the MBSR training without any memory~     training, active control MBT group- subjects on an 8 weeks waiting period for the MBSR~     training doing an 8 weeks MBT memory training instead, Wellness group - doing a structured~     program using relaxing massage and calming computerized chair (Brain Light).~      The hypothesis of the study is that MBSR improves memory function better than MBT when~     measured by MAT. Compared to both active and passive controls, MBSR training induces~     specific morphologic changes in the brain, indicated by a volume change of the voxel based~     morphometry method of 5% of a defined brain region. In comparison to smaller and less~     neuroplasticity induced by MBT on memory brain regions, MBSR induces greater volume changes~     on hippocampus and amygdala and stress reduction than the wellness program.~   "
29367|NCT02672748|"~     The Growing Resilience research leverages reservation-based assets of land, family, culture,~     and front-line tribal health organizations to develop and evaluate home food gardens as a~     family-based health promotion intervention to reduce disparities suffered by Native~     Americans in nearly every measure of health. Home gardening interventions show great promise~     for enabling families to improve their health, and this study aims to fulfill that promise~     with university and Wind River Indian Reservation partners. The investigators will develop~     an empowering, scalable, and sustainable family-based health promotion intervention with,~     by, and for Native American families and conduct the first RCT to assess the health impacts~     of home gardens.~   "
29368|NCT02672735|"~     The occupation of firefighting is considered to be one of the most dangerous occupations in~     the United States (U.S.). As such, a high prevalence of musculoskeletal injuries (MSKIs)~     have been observed among the firefighter population. This high rate of MSKI has created an~     extremely large financial impact on fire departments across the United States. Therefore,~     interest in developing methods of identifying those at risk for developing a future MSKI and~     interventions designed to prevent these MSKIs from happening has grown among both the~     firefighter population, as well as among researchers and practitioners.~      Previous research has demonstrated relationships between MSKI and altered movement patterns.~     In addition, researchers have started to demonstrate the ability of functional movement~     assessments to predict future MSKI in various populations, including firefighters. Two of~     these functional movement assessments include the Functional Movement Screen (FMS) and the~     Movement Efficiency (ME) Test, which is a component of the Fusionetics Human Performance~     System. These assessments both quantify the overall functional movement quality of an~     individual by creating a composite movement score (i.e., Total FMS & Average ME Test scores,~     respectively).~      In addition, various theoretical models of corrective exercise programming have been~     proposed. These programs are designed to restore optimal neuromuscular control and correct~     any identified neuromuscular imbalances observed during the movement assessment through the~     use of simple and easy-to-follow exercises. The Fusionetics Human Performance System~     utilizes one such model, with the goal of improving the functional movement quality of an~     individual by correcting the aforementioned neuromuscular deficiencies observed during the~     ME Test. Based on this framework, these corrective exercise programs theoretically lower the~     risk of MSKI of the individual as well.~      However, there is currently a lack of research in the literature examining the influence of~     corrective exercise programming on functional movement quality among the active-duty~     firefighter population. As such, it remains unknown if a corrective exercise intervention is~     capable of significantly improving functional movement quality among active-duty~     firefighters. In addition, recent research suggests that various health and fitness measures~     are associated with functional movement quality. These measures include total body power~     output, lower extremity muscular strength, and core muscular endurance. As such, an~     examination of the influence of a corrective exercise intervention on measures of health and~     fitness among active-duty firefighters is warranted.~   "
29369|NCT02672722|"~     Renal parenchymal blood flow can be divided in cortical and medullary blood flow. Changes~     and factors affecting renal medullary blood flow have not been studied in detail previously~     as investigators/doctors did not have tools to monitor renal medullary blood flow in vivo.~     Since Trueta first described renal medullary blood flow, multiple attempts have been made to~     study renal medullary blood flow using invasive methods. Recently renal medullary blood flow~     measurement using contrast US has emerged as a promising technique that investigators can~     use to study renal medullary blood flow in vivo. In this study investigators are aiming to~     study changes in renal parenchymal (cortical and medullary) blood flow with exercise in~     healthy subject.~   "
29370|NCT02672709|"~     This study aims to determine the effects of end-stage renal disease on the pharmacokinetics,~     pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label~     pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for~     nine days. The concentration of the drug will be measured with repetitive blood tests the~     first and the eighth day of administration (non-dialysis days). The same blood tests will be~     repeated before, during, and after dialysis on dialysis days. If the study shows inadequate~     or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily~     dose.~   "
29371|NCT02672696|"~     The aim of the study is to compare Tip-Apex Distance values in two groups of patients after~     intramedullary nailing of proximal femur. The first group of patients is operated with the~     help of a 3D reconstruction device connected to the standard fluoroscopy allowing the~     surgeon to visualize directly the exact position of the tip of the trans-cervical screw~     while the second group (which is the reference-group) is operated with the help of~     fluoroscopy alone.~   "
29383|NCT02672540|"~     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a~     vaso-occlusive crisis who are admitted to the hospital for treatment.~   "
29373|NCT02672670|"~     The aim of this proposed PhD study is to test the effectiveness of a newly developed~     coping-oriented supportive programme (COSP) for Chinese people with SCI during their early~     period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to~     develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the~     effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their~     coping abilities, self-efficacy, mood status, and life satisfaction, when compared to those~     receiving routine care in another two rehabilitation wards. This proposed PhD study is a~     quasi-experimental study, using repeated-measures, comparison group design. The study will~     be conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in~     each of the two study groups (i.e., one intervention and one comparison group). The~     intervention group will receive the COSP including 8 weekly sessions, and the comparison~     group will receive usual rehabilitation care in brief didactic group-based education.~     Outcome measures will be examined at baseline and immediately, 1- and 3-month after~     completion of the interventions. The primary outcomes of this proposed study are coping~     ability and self-efficacy, while the secondary outcomes include mood status, life~     satisfaction, and pain. All data will be analysed using SPSS for Windows, version 21.0.~     Descriptive statistics will be employed for demographic and disease-related data and outcome~     scores. Data analysis for intervention effects will be based on both Per-protocol (PP)~     analyses and Intention-To-Treat (ITT). The missing data will be handled by the Last~     Observation Carried Forward (LOCF) strategy. Inferential statistics will be conducted for~     between-group and within-group comparison with specific considerations with the measurement~     level of the data and the fulfillment of the statistical assumptions of parametric or~     non-parametric tests, and further consider to use multivariate analysis of covariance~     (MANCOVA) or the analysis of covariance (ANCOVA).This study will provide evidence on the~     clinical effectiveness of the coping-oriented supportive programme in improving patients'~     psychological adjustment to SCI during earlier stage of inpatient rehabilitation, enhancing~     their psychosocial adaptation to the illness and subsequent life satisfaction and hence,~     integrating this psychosocial intervention into the conventional treatment and SCI~     rehabilitation practices.~   "
29374|NCT02672657|"~     Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite~     needs perceived by elderly patients might differ from those of younger patients, there is a~     paucity of published data assessing the specific evolution and relevant determinants of~     health-related quality of life (HRQoL) in older patients with cancer. Such determinants may~     include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional~     status or socioeconomic features, but also practical organization of care -frequency,~     geographical distance, supporting measures -, or psychosocial and material support - social~     network, housing conditions and contextual neighborhood features. Comparatively to dementia~     or cancer in younger patients, little is known in the oncogeriatric field of the impact on~     caregivers' perceived burden and HRQol of the support they provide to patients. Further, the~     potential interactions between patients' and caregivers' HRQoL remain largely unknown, while~     caregivers are often themselves old with chronic diseases and/or daily living activities'~     limitations.~      The DEQOLAGE study is a prospective observational cohort study that aims to describe the~     HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first~     year following the diagnosis of the disease as well as the HRQoL and burden in their main~     caregivers. This study will allow a comprehensive assessment of multiple determinants of~     HRQoL operating at different levels, including individual (cancer type/location/stage,~     treatment type/intensity, comorbidities, nutritional status or socioeconomic features),~     contextual (social network, housing conditions and contextual neighborhood features) and~     organizational factors (frequency, geographical distance, supporting measures). We also~     hypothesize that complex interactions may operate between patient's and caregiver's HRQoL~     and perceived burden. Quality of life measurement will be based on two recent scales~     specifically designed for the elderly to confirm their psychometric properties and in-field~     feasibility.~   "
29375|NCT02672644|"~     Study is designed to characterize subject and treating investigator reported outcomes in the~     early post-treatment period, following bilateral correction of nasolabial folds using~     Emervel Classic and Emervel Deep.~        1. to evaluate subject-reported return to social engagement, after the initial treatment~          (Baseline/Day 1 visit).~        2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30-~          subject/investigator reported~        3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.~        4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to~          post-treatment follow-up time points at day 14 and Day 30 - investigator reported~        5. to evaluate all adverse events during the course of the study~   "
29376|NCT02672631|"~     The aim of this study is to determine whether clinical, sensory and motor development~     correlated with the values obtained from Electroneuromyography and DTI in postoperative~     follow up patients who underwent primary repair after the total median nerve injuries.~      Median nerve is one of three major nerves of hand and forearm and often injure with glass~     etc, in follow up of healing; clinical examination and ENMG are often used. Both of these~     methods are subjective, noninvasive and objective new method is required. In this context;~     differences between intact, recovering and not healed nerve tissue's diffusions have led to~     the hypothesis; The recovery of the repaired nerve tissue can be monitored by Diffusion~     Tensor Imaging method.~   "
29377|NCT02672618|"~     The purpose of this study is to explore manifestations of Heart Failure Using Infrared~     Thermal Imaging Technology.~   "
29378|NCT02672605|"~     This study is a randomized controlled trial designed to measure abortion stigma related to~     the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive~     the validated Individual Level Abortion Stigma Scale either before or after consent via the~     Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in~     the two groups.~   "
29379|NCT02672592|"~     Obesity and the metabolic syndrome in men are associated with a high prevalence of~     hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines~     and pro-inflammatory cytokines such as IL-1-beta, IL-6 and tumor necrosis factor-alpha which~     in turn suppress the hypothalamic-pituitary-gonadal (HPG) axis, leading to hypogonadism.~     This pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis.~     TestIL is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial~     to test the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on~     HPG axis and increases testosterone levels in men with metabolic syndrome.~   "
29380|NCT02672579|"~     This purpose of this study is to validate two measures of chronic itching in kids: itch~     severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).~   "
29381|NCT02672566|"~     Constituted vascular intrauterine growth restriction (CVIG) is correlated to an abnormal~     placenta development, with an alteration of the maternal-fetal circulation, coagulation~     troubles, and apparition of placental infarcts. CVIG represents the third cause of perinatal~     mortality in France, and is associated to an important morbidity. For birth-weights < 10th~     percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal~     weights. 35% of CVIG are linked to vascular causes and are integrated in the placental~     vascular diseases.~      To answer this objective, researchers propose a multicentric clinical trial, randomized,~     open, in two parallel groups, comparing the enoxaparin subcutaneous administration at~     preventive doses associated to the usual care (group 1) versus the usual care only (group~     2). The inclusion of 81 patients per group is scheduled, meaning 162 patients in total.~     Participation for each patient starts at the first consultation until 1 month after~     delivery. Inclusion time is 22 months. Total duration is 26 months.~   "
29382|NCT02672553|"~     The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive~     surgical approach (MIS) with any commercially available aortic bioprosthesis in standard~     full ster-notomy surgical approach.~   "
29386|NCT02672501|"~     In the conventional treatment options, B cell leukemia could be treated with chemotherapy~     drugs or HSCT. But chemotherapy could barely cured leukemia. And HSCT is often limited by~     lacking of HLA-matched donors, even if those patients who received HSCT still could be~     relapsed. And now, chimeric antigen receptor modified T cell infusion maybe an effective~     treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized~     hinge and transmembrane domain to treat patients with relapsed or refractory B cell~     leukemia, including relapsed cases after HSCT. The purpose of this study is to assess the~     safety and efficacy of this 2nd CAR-T cells. At the same time, evaluating the possible and~     clinical responses of using donor-derived T cells engineered CAR-T cells.~      Detailed Description: This study is being conducted to assess anti-CD19-CAR-T cells safety~     and efficacy in treating patients with B cell leukemia. The investigators constructed a 2nd~     CAR, CD19 as target protein, 4-1BB as co-stimulator. And optimized the spatial conformation~     by a suitable hinge & transmembrane domain sequences. The source of T cells for CAR-T is~     from two aspects, one is autologous, the other is donor-derived (only suitable for patients~     received HSCT before and relapsed). The infusion dose is (1-5)×106 CAR positive T cells/kg,~     and the specific cells numbers depend on the situation of individual CAR-T cells~     preparation.~   "
29387|NCT02672488|"~     Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got~     much more attentions recently. It has been shown that metformin exerts anti-cancer~     activities in several cancers, including primary liver cancer. In this phase II study,~     safety and efficacy of the combination of metformin and sorafenib will be evaluated in~     patients with advanced hepatocellular carcinoma.~   "
29388|NCT02672475|"~     This phase I trial studies the side effects and best dose of Galunisertib when given~     together with paclitaxel in treating patients with androgen receptor negative or triple~     negative breast cancer that has spread to other places in the body. Some tumors need growth~     factors, which are made by the body's white blood cells, to keep growing. Galunisertib may~     interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy,~     such as paclitaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving Galunisertib together with paclitaxel may kill more tumor cells.~   "
29389|NCT02672462|"~     A single center, self-controlled pilot study on safety and efficacy of renal denervation in~     treatment of hypertension.~   "
29390|NCT02672449|"~     The aim of this research project is to test the feasibility and safety of a new treatment~     schedule for high risk prostate cancer that allows the administration of high doses to the~     prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.~   "
29391|NCT02672436|"~     The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject~     with diabetic foot ulcers.~   "
29392|NCT02672423|"~     The purpose of this study is to measure how much abemaciclib gets into the blood stream and~     how long it takes the body to get rid of it when given as capsules versus a tablet(s). The~     effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the~     tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information~     about any side effects that may occur will also be collected.~      This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B~     will last about 60 days including follow-up. Screening may occur up to 28 days before the~     first dose of study drug. Participants are only allowed to enroll in one part.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
29393|NCT02672397|"~     The purpose of this study is to see if an educational intervention provided to pregnant~     women in early labor has an effect on their decision to use epidural anesthesia for relief~     of labor pain. The study will also investigate differences between Hispanic and non-Hispanic~     white women in their attitudes and beliefs regarding epidurals in labor. Previous studies~     have shown that Hispanic women receive epidural anesthesia in labor much less frequently~     than their non-Hispanic white counterparts. The investigators hypothesize that the rate of~     epidural use will be higher in subjects who receive the educational intervention than in~     those who do not.~      Women who have been admitted to the OHSU labor and delivery unit will be screened for study~     eligibility. In order to minimize the influence of socioeconomic factors, only women~     receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18~     years, having a fetus of at least 24 weeks gestational age, and being categorized as~     American Society of Anesthesiologist category 1 to 3. Exclusion criteria include any~     condition that either excludes or mandates neuraxial anesthesia. Midwife patients are also~     excluded from this study. Those who meet study criteria will be approached by a member of~     the study team and informed consent will be obtained.~      Subjects will be randomly assigned to receive an educational intervention about epidurals or~     no educational intervention. Hispanic and non-Hispanic subjects will be randomized~     separately, yielding four study groups (Hispanic - intervention; Hispanic - control;~     non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll~     approximately 176 women, 44 in each group.~      All subjects will complete a survey in early labor and again 1 to 2 days postpartum that~     asks about common beliefs and misconceptions regarding epidurals. Subjects in the~     intervention group will receive an educational pamphlet and watch a video in their native~     language (spanish or english) about epidurals, and have an opportunity to ask questions.~     Study staff will collect limited information about the subject's labor and delivery from the~     electronic medical record.~   "
29394|NCT02672384|"~     This study evaluates the diagnostic performances of Point of Care P. gingivalis test in~     saliva with serum IgG P. gingivalis, in reference to dental examination as a gold standard~     in patients hospitalised in intensive care unit (ICU)~   "
29395|NCT02672371|"~     The study is a randomized clinical trial that is assessing the effects of sensory training~     on pain modulation, cognition, and physical endurance (time to fatigue) in healthy~     participants~   "
29396|NCT02672358|"~     This is an open-label, multicenter, non-randomized, single arm, phase II study to assess~     efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with~     any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.~      Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination~     therapy. Patients may continue study treatment until disease progression, unacceptable~     adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the~     study. Patients who have met the criteria for disease progression (PD) according to RECIST~     v1.1 may continue to receive study treatment if the investigator believes the patient is~     receiving clinical benefit and the patient is willing to continue on study treatment. After~     discontinuation of study treatment, all patients will be followed for survival until death,~     lost to follow-up, withdrawal of consent, or end of study.~   "
29454|NCT02671591|"~     The overarching goal of the proposed study is to determine effective outreach methods~     designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP~     and to identify and modify psychosocial and structural predictors of PrEP acceptance.~     Specifically, the objective of this pilot study is to test the feasibility of a motivational~     interview-based intervention designed to improve PrEP acceptance among YBMSM.~   "
29397|NCT02672345|"~     Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a~     feature that allowed more precision and tranquility to the heart surgeon. But their~     influence on exacerbation of inflammatory response can unbalance the whole homeostasis so~     happens surgical trauma. The attenuation of the systemic inflammatory response in major~     surgeries like cardiac surgery for aortic aneurysm appears to represent an important advance~     in reducing morbidity and mortality of these patients. Some studies suggest that inhaled~     anesthetics such as sevoflurane appear to play an important role in this control, but the~     mechanism by which this happens is still unclear. This study has the primary purpose of~     analyzing from a clinical study sevoflurane inhalation anesthetic can change the~     inflammatory response induced by CPB, significantly reducing the release of inflammatory~     markers, especially elastase PMN.~   "
29398|NCT02672332|"~     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel~     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.~   "
29399|NCT02672319|"~     Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After~     successful treatment of the acute bleeding episode, patients who do not receive follow-up~     treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2~     years. The presence of liver cancer and/or portal vein thrombosis has been associated with~     recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of~     patients developed at least 1 episode of variceal bleeding over the course of liver cancer.~      In patients with portal hypertension from cirrhosis, current guidelines recommend~     non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial~     bleeding, and either cyanoacrylate injection for variceal obturation or transjugular~     intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is~     unclear whether the above strategies will have the same clinical effect for patients with~     liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.~      Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection~     for variceal obturation has been described. In a study of patients with gastric variceal~     bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all~     patients and 96% of the gastric varices remained obliterated during the follow-up period. To~     date, there has been no dedicated study to evaluate the role of EUS guided glue injection~     for prevention of future bleeding in patients at high risk for recurrent variceal bleeding~     such as those with liver cancer or portal vein thrombosis.~      The investigators propose this study to evaluate the feasibility and safety of EUS guided~     glue injection for follow-up variceal treatment in patients at high risk for recurrent~     variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.~   "
29400|NCT02672306|"~     The primary purpose of this study is to evaluate the safety and the efficacy of (Human~     Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease~     (AD).~   "
29401|NCT02672293|"~     Over 20 million people in North America (including 2 million Canadians) have chronic kidney~     disease. These individuals die from diseases of the heart and blood vessels more often than~     they need dialysis. This is due to hardening of the arteries caused by calcium deposits~     inside the blood vessel walls. These deposits damage the vessels, causing them to lose~     flexibility. This makes them unable to respond to the changing demands of the body, and~     eventually leads to blockages such as stroke and ultimately death.~      High levels of phosphate in the blood have been consistently linked to the development of~     calcium deposits inside blood vessel walls. The kidney is the only organ in the body that~     can eliminate phosphate that is not required by the body. As kidney function becomes worse,~     body levels of phosphate increase. However, investigators do not know the time point in the~     course of kidney disease that problems begin in the way phosphate is eliminated into the~     urine by the kidneys. Investigators will test the response of the kidneys to a phosphate~     challenge taken by mouth in subjects who are having accurate measures of kidney function~     performed by a method called 'inulin clearance'.~      The investigators believe that the results of this study will provide important information~     identifying when investigators should be concerned about body levels of phosphate~     increasing. This information may lead to changes in the way investigators treat patients by~     reducing the levels of phosphate in the diet at a much earlier time point then is presently~     recommended.~   "
29402|NCT02672280|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     medical collagen membrane with umbilical cord derived mesenchymal stem cells in the~     treatment of patients with skin defects.~   "
29403|NCT02672267|"~     The purpose of this study is to assess the safety, tolerability and preliminary efficacy of~     human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered~     intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).~   "
29404|NCT02672254|"~     The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical~     excision. Nevertheless, surgery is not always an option as a consequence of the age and/or~     the health status of the patient. One of the objectives of this study is to assess the~     effects of cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro.~     In order to enhance the effectiveness of this combined treatment, the temporal fractionation~     of the platinated compound is expected to be performed.~   "
29405|NCT02672241|"~     The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in~     combination of radio-chemotherapy for the treatment of brainstem tumor in children.~   "
29406|NCT02672228|"~     This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble~     technology (MalariSense) for malaria diagnostics. The MalariSense technology will use a~     highly innovative approach based on the transdermal non-invasive detection of vapor~     nanobubbles produced by the excitation of malaria-specific hemozoin by safe, low-energy~     laser pulse. The objectives of this study will be to determine the sensitivity and~     specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a~     health facility in The Gambia and to identify factors influencing the diagnostic accuracy of~     MalariSense~   "
29407|NCT02672215|"~     A theory-driven, web-based, computer-tailored advice to influence sitting at work was~     developed. The study investigated the effects of this computer-tailored intervention to~     influence workplace sitting on behavioural measures.~   "
29408|NCT02672202|"~     To create a data base that will facilitate the enrichment of the insights regarding~     post-operative pain development, and to identify those individuals with the potential to~     develop this kind of pain. The identification will be based on the individualized pain~     modulation profile, composed of a battery of tests as detailed below.~   "
29409|NCT02672189|"~     The current study will evaluate systematically the efficacy and cost-effectiveness of two~     internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the~     severity of menopausal symptoms and improving copings skills with regard to hot flushes and~     night sweats as well as improving sexual functioning, improving quality of sleep, reducing~     emotional distress and improving quality of life in younger breast cancer patients who~     experience treatment-induced menopause.~   "
29410|NCT02672176|"~     The overall goal of this proposal is to enhance the supports and resources available to~     patients with diabetes to assist them to achieve their health goals. The investigators will~     evaluate an innovative program that uses nurse health coaching, motivational interviewing~     techniques, wireless sensors and mobile health (mHealth) technology. In this program,~     patients will receive timely, tailored nurse coaching feedback to facilitate behavior change~     using mHealth technology, thus bridging bidirectional exchange of meaningful information~     among patient, nurse coach and provider. The investigators will conduct a randomized~     controlled trial among patients receiving chronic disease management at the University of~     California, Davis Primary Care Network. The patients who are eligible for inclusion in the~     study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination)~     administered by UC Davis Health Management and Education; or 2) the Patient and Provider~     Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in~     Diabetes. The hypothesis is that patients in the P2E2T2 arm of the study will be more~     engaged in identifying and achieving health goals related to their diabetes and will achieve~     better health outcomes compared to patients receiving usual care.~   "
29411|NCT02672163|"~     This study aims to evaluate the safety and clinical feasibility of epicardially delivered~     autologous atrial appendage micrografts in the treatment of heart failure. The micrografts~     consisting atrial-derived cells and their extracellular matrix, are placed on an infarction~     scar during CABG surgery.~   "
29412|NCT02672150|"~     This is a multi site experiment to evaluate the impact of various strategies for increasing~     the use of evidence based screening, assessment and linkage to substance use treatment. All~     sites collect baseline data and receive a core intervention. Half are then randomly assigned~     to get an additional year of coaching to facilitate implementation.~   "
29413|NCT02672137|"~     Cluster randomized open-label experimental study multi-center of 24 hospitals to either~     knowledge translation vs usual care to improve care of patents hospitalized for acute~     coronary syndromes.~   "
29414|NCT02672124|"~     The aim of this study is to evaluate the microbiological safety and the efficacy of a new~     not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In~     Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the~     procedure and to avoid mismatches by ensuring the same results of the standard techniques in~     terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate,~     and a better euploid status of the embryos.~   "
29415|NCT02672111|"~     Open-label multi-center, 12-month safety study, consistent with standard practice for~     long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly)~     and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.~   "
29416|NCT02672098|"~     This is a phase I prospective study with the primary objective to compare the efficacy and~     safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)~     in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible~     patients consenting to this protocol will undergo their scheduled surgical procedure. After~     surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800~     mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion~     using the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase~     (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV~     platinum-based chemotherapy. The proportion of patients who are without evidence of~     recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.~   "
29417|NCT02672085|"~     Background and Rationale:~      Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It~     has been showed effective in different parts of the body, but current evidences for rotator~     cuff PRP infiltration remains poor. Some studies that tested infiltrations on transfixing~     lesions showed no statistically significant effect of PRP on tendon healing. The~     investigators believe that this might be explained by a flushing effect of PRP into~     subacromial space or glenohumeral joint. Therefore, it was decided to focus this study on~     interstitial lesions, in which PRP is entrapped into the lesion for a long time.~      Objective:~      The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear~     repair better than needling procedures of torn tendon in participants with supraspinatus~     interstitial tears.~      As secondary objective, we will study symptoms alleviation in same way. Primary outcome:~     Primary outcome: Supraspinatus tear size change from baseline will be compared between cases~     receiving two PRP injections and controls receiving torn tendon needling, 6 months after~     second injection.~      Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score,~     Shoulder pain disability index, and Visual analogue scale changes from baseline will be~     compared between cases receiving two PRP injections and controls receiving torn tendon~     needling, 0,1,3, and 6 months after second injection.~      Study design: This case-control study is randomized 1:1 between PRP (intervention group) and~     needling (Control group). It is a superiority trial that will include 84 patients suffering~     from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will~     beneficiate from standard physical therapy program. PRP and needling will be repeated 2~     times, at one month interval. First injection will occur up to two months after recruitment.~     Clinical follow-up will occur from second injection to one year after second injection, with~     clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control~     MRI 6 months after second injection.~      Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP~     injection. PRP will be extracted with Regenlab® extraction kit. No other medications used.~      Control Intervention (if applicable): Supraspinatus tendon needling with intralesional~     saline water injection.~      Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10%~     of dropout has been taken in consideration.~      Study Duration: 24 months from recruitment of the first patient to the last follow-up visit.~     Scientific report will be written within the two months following recruitment of the last~     patient.~      Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017~   "
29418|NCT02672072|"~     I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined~     as the presence of job strain as defined by Karasek.~      II. Main secondary outcomes~        -  ICU nurses stress at one year~        -  Burnout~        -  Intent-to-leave the ICU~        -  Quality of life~      III. Design~      Prospective, randomized, open study comparing 2 groups of ICU nurses:~      Simulation group and Control group~      Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to~     take into account differences between the ICUs regarding organization, activity, patients…).~      This study is observational because nurses can participate to this training when they want.~     The fact that nurses are in control group delays their participation to this training but~     does not forbid them to particpate. The nurses from control group will participate to~     training at the end of study.~      IV. Specific measures Control group: none~      Simulation group: 5-day specific training with dedicated scenario done by an ICU expert~     simulation team~      V. Study duration 48 months~      VI. Ethical aspects - Reglementary concerns~        -  Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière~          de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de~          l'Informatique et des Libertés (CNIL)~        -  Information to the participants prior inclusion~      VII. Study population Job strain evaluated in a French study was 59% . The same rate was~     observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We~     therefore hypothesized that the intervention (simulation) should be able to reduce the job~     strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this~     study needs to include 185 patients per arm. To take into account few participants who will~     not complete the study, we aimed to include a total of 400 ICU nurses.~   "
31168|NCT02649127|"~     This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service~     Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure~     therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic~     exercise, or 4) self-care.~   "
29419|NCT02672059|"~     In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory~     symptoms and:~        -  Sensory nerve dysfunction.~        -  Cutaneous small nerve fibre innervation density.~        -  Psychological co-morbidity.~        -  Circadian rhythm disturbance co-morbidity.~        -  Functionality and Quality of life.~        -  Patterns of human brain activity in a subset of patients that consent to participate in~          the FMRI (functional magnetic resonance imaging) component of PINS.~           2. We will also collect blood samples in this phenotyped cohort of patients. These~          blood samples coupled with detailed phenotype data will investigate potential gene~          associations only in the development of painful neuropathy.~           3. Knowledge gained from the study will be used to aid the further development of pain~          questionnaires, designed to detect patients with painful neuropathy.~           4.Knowledge gained from the study will be invaluable in informing on-going~          investigations of painful peripheral neuropathy in animal models, both in our~          laboratory and others.~   "
29420|NCT02672046|"~     The aim of the study is to evaluate an algorithm to screen patients with a possibility of~     meniscal injury referred to a sports injury outpatient clinic by using patient-reported~     symptoms. It will be investigated whether the algorithm is able to identify which patients~     are deemed relevant to undergo assessment by a physician (i.e. in case the patient need to~     undergo surgery) and which patients are relevant to undergo assessment by a physiotherapist.~     This will be evaluated by estimating the sensitivity of the new algorithm compared to actual~     relevancy based on the traditional clinical assessment of the patients.~   "
29421|NCT02672033|"~     This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately~     before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin~     layer of tissue that covers the lungs and lines the interior wall of the chest cavity).~     Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Hypofractionated radiation therapy is a type of radiation therapy in which the total~     prescribed dose of radiation is divided into fewer but larger doses as compared to~     conventional radiation therapy. Giving accelerated hypofractionated radiation therapy~     immediately before surgery may improve survival, and may also reduce side effects~     experienced by patients with pleural mesothelioma.~   "
29422|NCT02672020|"~     Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two~     rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers~     improved thanks to the French COMETE network originally based on two clinical centers (HEGP~     and Cochin) well organized for clinical and biological samples collection. Over the last 10~     years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and~     oncogenesis of these tumors and identified molecular signatures discriminating between~     benign and malignant cancers by integrated genomic approaches. This strategy was highly~     successful in delivering new diagnostic applications of genomics technologies that now~     appear as potentially suitable for rapid implementation in routine clinical care.~      The main objective of COMETE-TACTIC is to provide an easy-to-use identity card of the~     adrenal tumors that will allow a personalized à la carte management of the patient and,~     when indicated, to the indication of the most accurate molecular targeted therapy.~      We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options~     proposed to affected patients will require,~        1. the transfer to routine practice and the prospective validation of the novel diagnostic~          and predictive biomarkers issued from recent discoveries (genetics, genomics,~          histological biomarkers);~        2. the implementation of the translational research projects based on the COMETE~          collection to identify circulating diagnostic, prognostic and therapeutic genetic and~          metabolic biomarkers that could be used as non-invasive liquid biopsies.~   "
29423|NCT02672007|"~     This study aims to investigate these research questions:~        1. Is there a difference in the results obtained, when respiratory rate is measured~          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)~          compared with a research assistant using a criterion standard approach?~        2. Is there a difference in the results obtained, when respiratory rate is measured~          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)~          compared with hospital staff's current clinical practice?~   "
29424|NCT02671994|"~     In a randomized controlled trial, the investigators wish to investigate, if oncologic~     treatment decision based on G8 screening followed by geriatric assessment and subsequent~     MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to~     standard assessment (PS and clinical assessment) in oncologic treatment decision.~   "
29425|NCT02671968|"~     Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the~     frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily~     injections) that are at risk for hypoglycemic events.~   "
29426|NCT02671955|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in~     participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D)~     for further evaluation in specific tumor types.~   "
29427|NCT02671942|"~     To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD~     patient.~   "
29428|NCT02671929|"~     The purpose of this study is to determine the feasibility and effectiveness of an~     internet-based self help program concerning satisfaction with the treatment and their life,~     depression and anxiety. Both study groups get access to the internet-based self-help~     program. The intervention group receives additional feedback to their progress in the~     program from an online therapist. The investigators hypothesize that (1) at least 75% of the~     patients in the intervention group are satisfied or very satisfied with the self-help~     program, (2) 50% of the patients in the intervention group work with all eight units and (3)~     patients of the intervention group have a higher emotional competence than the patients of~     the control group at the end of the self-help program.~   "
29429|NCT02671916|"~     The goal is to capture the Quality of life and survival of patients one year after the stay~     at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the~     ICU stay patients will be send a Quality of Life questionnaire they need to fill out and~     return. All data will be evaluated together.~   "
31307|NCT02647320|"~     The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic~     control relative to placebo, based on changes in HbA1c, with acceptable safety and~     tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with~     metformin.~   "
29430|NCT02671903|"~     This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a~     sub-population of patients with heart failure.~      All patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with~     one of the leads positioned on the His bundle in order to obtain direct His-bundle capture.~     There will be a 2-month run-in period where the device is not active.~      A double-blinded cross-over design will then be employed to investigate the effect of His~     bundle pacing. Patients will be allocated in random order to six month treatment periods in~     each of the following two states (1) No pacing; (2) AV optimised direct His-bundle pacing.~     Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation.~     Treatment allocation will be blinded to the endpoint assessor and the patient.~      126 patients will be needed to detect the expected effect size on the primary endpoint with~     90% power. A total of 160 patients will be recruited to allow for patient drop-out.~   "
29431|NCT02671890|"~     This partially randomized phase I trial studies the side effects and best dose of disulfiram~     when given together with gemcitabine hydrochloride in treating patients with a solid tumor~     that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to~     other places in the body (metastatic) and to compare whether disulfiram and gemcitabine~     hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer~     patients and is common in a multitude of other cancers. Patients with metastatic cancer and~     weight loss sometimes are not able to receive treatment due to physical weakness or~     debility. Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor~     induced muscle wasting. Disulfiram may also help gemcitabine hydrochloride work better by~     making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet know whether giving gemcitabine hydrochloride with or without disulfiram is a~     better treatment for unresectable solid tumors or metastatic pancreatic cancer.~   "
29432|NCT02671877|"~     The aim of this study is the evaluation of preoperative transnasal fiberoscopy, as a~     possible predictor of difficult laryngoscopy and intubation during elective general~     anesthesia in an adult population.~      Transnasal fibercoscopy is a minimally invasive examination and is routinely performed~     during ENT evaluation; on the other hand, current strategies used to predict the ease of~     intubation are still not sufficiently sensitive and specific, and an unexpected difficult or~     failed intubation at the induction of general anesthesia is a seriuos, and potentially~     fatal, emergency in anesthesia.~      In literature, a correlation between anatomical and functional parameters highlighted by~     fiberoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor~     indagated.~      If proven, this might give the Anesthestiologist further information about the expected~     difficulty of laryngoscopy and intubation, guiding a different - and hopefully safer -~     anesthesiological strategy.~   "
29433|NCT02671864|"~     Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which~     may have beneficial effects on the cardiovascular system but harmful effects on the retina .~     This project investigate the possible link between incretin therapy and Severe Diabetic~     Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1~     analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these~     antidiabetic classes.~   "
29434|NCT02671851|"~     Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative~     analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.~      Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA)~     could postpone time to first pain and improve postoperative analgesia in patients undergoing~     bilateral reduction mammoplasty.~      Design: A historical cohort study. Patients: Of the 70 female patients who underwent~     bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional~     anaesthesia database.~      Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four~     patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine~     0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were~     administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20%~     above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit~     (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g~     and/or paracetamol 3x1g on wards (NRS≥4).~      Main outcome measures: The primary endpoint was time to first pain after the surgery.~     Secondary endpoints were intra- and postoperative opioid and other rescue analgesic~     requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and~     vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2~     days.~   "
29435|NCT02671838|"~     Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA)~     patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the~     investigators are conducting a randomized controlled trial to test out an intervention to~     improve medications adherence among low adherers. This intervention involves the use of a~     musculoskeletal ultrasound program which allows RA patients to visualize their joint~     inflammation and damage real time while treatment adherence is simultaneously reinforced. In~     doing so, the investigators hope to improve patients' understanding of their joint disease~     and motivate the participants to adhere to their medications.~   "
29436|NCT02671825|"~     The purpose of this study is to compare drug blood levels of multiple formulations of~     inhaled PUR0200 to each other and to the reference product with and without oral charcoal.~   "
29437|NCT02671812|"~     The general aim of this project is to investigate the long-term treatment outcome after~     implant therapy. The patients' satisfaction with implant treatment will be studied and~     correlated to biological and technical problems. The survival rates of implants at patient~     level and the degree of bone loss of remaining teeth and implants will be calculated. The~     levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects~     and at healthy sites will be analyzed in order to study the correlation between cytokine and~     bone loss marker levels, and clinical conditions. Independent variables which could be~     regarded as significant risk factors or risk predictors on the incidence of peri-implantitis~     are aimed to be identified~   "
29438|NCT02671799|"~     This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for~     treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].~   "
29439|NCT02671786|"~     Provision of community based health care to severely malnourished children (Age group: 6~     months through 5 years) in 16 tribal villages by trained semi-literate village health~     workers.~        1. Treatment of severely malnourished children.~        2. Growth monitoring of all children below the age of 5 years.~        3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.~        4. Management of resistant or relapsed severely malnourished cases by pediatrician.~        5. Intensive behavior change communication of parents of children below the age of 5 years~          for proper nutrition.~   "
29440|NCT02671773|"~     Previous work has determined that there are significant differences in the communities of~     bacteria found in the airways of asthmatic patients compared to those found in the airways~     of healthy people.~      It is not yet clear if these bacterial communities are similar in all patients with asthma~     or if they are different in people with more severe asthma, with different types of asthma~     or between asthma patients taking different treatment. This is important to know as any~     differences in the bacteria present between groups may help to explain why people with~     asthma do not have the same features of disease.~      This research aims to determine if there are any differences in the number and type of~     bacteria found in the airways of asthmatic patients (1) with different severities of asthma~     and (2) who use different types of inhaled steroid treatment for asthma.~      We will do this by detecting the DNA of bacteria present in phlegm samples from these~     patients. We will also take measurements of the different components of asthma to see if the~     bacteria are different in people with different types of disease.~      As it is not yet clear if the bacteria detected in phlegm samples from one person may differ~     on different occasions, we will be taking more than one sample from some patients to see how~     similar this is over time.~   "
29441|NCT02671760|"~     The purpose of this study is to evaluate the effect of a combination drug product containing~     diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who~     sometimes have difficulty falling asleep or staying asleep, but who do not have chronic~     insomnia. The study involves 3 one-night stays in a sleep center in New York City.~   "
29442|NCT02671747|"~     The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two~     Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the~     two pilot communities and will complete three 90-minute workshop sessions over a 6 week~     period.~   "
29443|NCT02671734|"~     The investigators employed a randomized control study design to evaluate the efficacy of a~     video intervention augmenting informed consent discussions in improving parental and youth~     informed consent comprehension.~   "
29444|NCT02671721|"~     The purpose of this pilot study is to identify the optimal way to ventilate patients during~     abdominal surgery in order to reduce the amount of post-operative pulmonary complications in~     patients at moderate and high-risk for them.~   "
29445|NCT02671708|"~     Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative~     to allogeneic HSCT for low-risk and intermediate-risk acute myeloid leukemia (AML) without~     HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT~     remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY~     myeloablative conditioning regimens in low-risk and intermediate-risk AML undergoing~     auto-HSCT are evaluated.~   "
29446|NCT02671695|"~     the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on~     cardiac iron overload and cardiac functions in multi-transfused children with beta~     thalassemia major~   "
29447|NCT02671682|"~     This observational study investigates the efficacy and safety of immunoadsorption versus~     plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated~     syndrome who do not fully recover after a high doses of intravenous corticosteroids.~   "
29448|NCT02671669|"~     This is a randomized controlled trial of the feasibility and utility of implementing a~     smartphone application (MVN) to maintain compliance with a Heart Healthy lifestyle after~     discharge from a cardiac outpatient rehabilitation program. Patients will be randomized into~     one of two groups: usual care (control: UC) or Movn mobile application (intervention: MVN).~     This study will improve and strengthen data collection from this at-risk patient population~     by recording baseline clinical and psycho social measures while gaining insight into~     self-reporting of physical activity and frequency between the UC and MVN groups.~   "
29449|NCT02671656|"~     Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor~     of gout management success. Monitoring of uricemia in gout patients is therefore important~     and is presently done in the laboratory on serum samples obtained after venous puncture.~     This study aims at assessing the reliability of immediate uricemia measurement in a blood~     sample obtained by a mere fingertip puncture, by the HumaSensplus system, which is~     commercially available in the EU. Results obtained by the Humasens device will be compared~     to those of the standard measurement technique in serum and with a reference technique~     (liquid chromatography and mass spectroscopy). If the device appears reliable, it will allow~     self-measurement of uric acid by the gouty patient, in a similar way as diabetic patients~     measure their glycaemia following a fingertip puncture. This should improve patient~     monitoring and management effects.~   "
29450|NCT02671643|"~     Purpose: To determine the measurement properties of the asthma control test (ACT) in a~     prospective clinical study in an African American adolescent population.~   "
29451|NCT02671630|"~     Little is known about the effects of computerized cognitive training programs on mild~     dementia patients' health. The purpose of this study was to examine the effects of a~     community-based computerized cognitive training program.~   "
29452|NCT02671617|"~     This randomized control trial will determine the effect of short term high intensity~     interval training (HIIT) on physical fitness, in an elderly patient group with active~     cancer, prior to surgical resection.~      Half of the recruited patients will act as a control group and the other half will undergo a~     HIIT protocol.~   "
29453|NCT02671604|"~     In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum,~     intraoperative fluid restriction and prolonged Trendelenburg position may cause~     rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.~      In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative~     positioning, fluid restriction and length of surgery on development of RM in RARP patients~     during perioperative period.~   "
29455|NCT02671578|"~     BACKGROUND: The degree of consciousness during nitrous oxide use is still a matter of~     concern for both dentists and anesthesiologists. Investigators hypothesized that BIS levels~     do not vary according nitrous oxide concentration during minimum to moderate sedation in the~     dental treatment.~      METHODS: One hundred patients undergoing dental procedures demanding local anesthesia (1.8~     mL of 2% lidocaine with 1:100.000 epinephrine) were enrolled in this study. Initial pain and~     anxiety were measured by 11-point numerical and anxiety visual scales, respectively.~     Systolic/diastolic arterial blood pressure, SpO2, heart and respiratory rates, and~     psychomotor ability (Trieger test) were assessed before, during and after dental treatment.~     Sedation levels were evaluated by both BIS and sedation analogic scale at the same~     intervals. The duration of treatment along with nitrous oxide concentration and side effects~     were observed. Kruskal-Wallis, Friedman and Mann-Whitney tests were used (alpha=5%).~   "
29456|NCT02671565|"~     Osteoarthritis (OA) is a degenerative joint disease in which there is an imbalance between~     the breakdown and repair of the joint tissue. Intraarticular hyaluronic acid (HA) injections~     are used for the management of knee OA. Currently, there is limited and inconclusive~     evidence supporting use of HA injections for management of knee OA. The primary objective of~     our study is to evaluate the effectiveness of HA injections in the management of knee OA.~     Investigators will evaluate if HA injections prevent or delay knee OA surgical~     interventions.~   "
29457|NCT02671552|"~     This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to~     contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current~     clinical standard, in predicting treatment response in patients with kidney cancer~     undergoing cryosurgery (a procedure in which an extremely cold liquid or an instrument~     called a cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced~     ultrasound that does not involve a dye may help patients avoid side effects from a dye that~     is usually used in MRI or CT and may help doctors measure blood flow and determine whether~     the cryosurgery procedure treated the kidney tumor.~   "
29458|NCT02671539|"~     An open label monocentric phase II trial in adult males with a clinical phenotype of~     choroideremia and a confirmed molecular diagnosis of a null mutation in the gene encoding~     REP1 to assess the anatomical and functional outcomes, as well as the safety of a single~     subretinal injection of rAAV2.REP1 in 6 subjects with genetically confirmed choroideremia~     for up to 24 months.~   "
29459|NCT02671526|"~     This study is a validation study to document the acceptability of the revised~     Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with~     HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to~     evaluate the effects of the revised PACR program on the cognitive abilities (e.g.,~     attention, executive function), functional status and quality of life of individuals~     diagnosed with HAND. The secondary objective of the study is to collect relevant data to~     support a pre-investigational device exemption (IDE) submission to the FDA required before~     the pivotal randomized, controlled trial planned for Phase II.~   "
29460|NCT02671513|"~     SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this~     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390~     in Chinese advanced melanoma patients by using a 3+3 dose escalation.Preliminary efficacy~     will be also investigated in this study.~   "
29461|NCT02671500|"~     This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in~     treatment-naive and treatment-experienced participants with chronic hepatitis C virus (HCV)~     infection.~   "
29462|NCT02671487|"~     The purpose of this study is to determine whether war-traumatize male adolescents with~     behavioral and emotional problems who participate in mind-body skills groups will have~     improvement in behavioral and emotional problems, aggression, and posttraumatic stress~     disorder (PTSD) symptoms, compared to a wait list control group.~   "
29463|NCT02671474|"~     A single-center prospective interventional trial. Patients implanted with a sutureless~     bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012~     will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will~     be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT~     examination, preoperative clinical characteristics, and postoperative clinical data will be~     registered. Data will be collected prospectively and retrospectively. Informed consent will~     be obtained from patients meeting the inclusion criteria before the initiation of any~     study-specific procedures.~   "
29464|NCT02671461|"~     The purpose of this study is to determine whether BMS-986141 is effective in reducing the~     recurrence of stroke in people who recently had a stroke, or a transient ischemic attack~     (known as a TIA or mini stroke) and are receiving acetylsalicylic acid (also known as~     aspirin or ASA) to treat the stroke or TIA.~   "
29465|NCT02671448|"~     In this study, the investigators plan to see what happens when a person receives care in the~     home setting. They want to find out if caring for a patient who has been treated with an~     ASCT in the home setting is feasible. They want to find out what effects good and/or bad~     this will have on the patient's recovery and treatment after ASCT. Studies in other~     institutions have shown that providing care in the home setting after ASCT is safe,~     increases patient satisfaction, and can decrease the risk of infection. It is our hope that~     this new approach of providing care in the home setting will prove to be a feasible and safe~     option for patients at Memorial Sloan Kettering Cancer Center (MSK).~   "
29466|NCT02671435|"~     This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the~     safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of~     Durvalumab (MEDI4736) in combination with IPH2201 in Adult Subjects with selected advanced~     solid tumors.~   "
29467|NCT02671422|"~     At present there are no approved predictive tumour- or serum-derived biomarkers guiding~     usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of~     this NIS is to examine whether genetic/genomic markers (alone or combined with clinical~     covariates) could be used to predict OS in NSCLC patients eligible for treatment with~     Vargatef®. The investigations in this study are exploratory in nature and considered to be~     hypothesis generating. The results from these investigations may help to expand our~     understanding of the disease and the response to Vargatef®.~   "
29468|NCT02671409|"~     The spinal nerve injury in humans often results in neuropathic pain characterized by~     spontaneous burning pain accompanied by allodynia and hyperalgesia. In this sense,~     lomboisquiatalgia is a neuropathy that is characterized by narrowing the intervertebral~     foramen of the lumbar vertebrae, leading a lumbar chronic pain which irradiate to a lower~     limb, being a clinical condition of difficult treatment. Neural Mobilization is a~     noninvasive technique used by physiotherapists. The technique aims to restore mobility and~     elasticity of the peripheral nervous system by tenses which are imposed on the roots,~     nerves, spinal cord and their respective meninges. This technique has been standardized in~     basic research and has shown promising results. However, clinically, this technique lacks~     randomized, controlled and double blind studies. Therefore, the investigators have to~     evaluate the effects of Neural Mobilization technique in patients with lomboisquiatalgia. In~     this study the investigators will treat patients three times a week, with ten minute~     treatment time per session, with 25 oscillations per minute for ten sessions. Many tools~     will be used to assess the effects of the protocol applied, for example: evaluation sheet,~     visual analogue scale (VAS), quality of life assessment - WHOQOL-bref questionnaire of~     Roland Morris disability, oswestry index on disability (version 2.0), enzyme-linked~     immunosorbent assays for the measurement of cytokines in the blood tissue. In this way, the~     investigators can contribute and understand the mechanisms involved in the rehabilitation~     process.~   "
29469|NCT02671396|"~     The present study is to examine the effects of a virtual reality based balance training~     using the Kinect sensor on postural stability and functional balance in individuals with~     Parkinson's disease.~   "
29470|NCT02671383|"~     This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of~     darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir~     (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a~     nucleoside backbone, administered as a second line therapy in HIV positive individuals.~   "
29471|NCT02671370|"~     This study there are any associations between objective and subjective outcome measures,~     measuring the cervical range of motion and if the restriction matter to the patient.~   "
29472|NCT02671357|"~     This prospective observational study aims to improve the postoperative course after~     minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG)~     for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced~     recovery after surgery (ERAS) program.~   "
29473|NCT02671344|"~     Microarray experiments to assess the expression of thousands of genes providing vast amount~     of information.~      Because the molecular requirements in the different processes related to playback,on the~     hypothesis that there may be more apt semen samples for technical or other assuming~     molecular differences in RNA content messengers or gene expression profile between the They~     getting semen samples in gestation versus those who do not.~      In an attempt to give a functional data obtained view, it is to find out how many of these~     genes in donors who have obtained gestation, they are differentially expressed in playback~     related processes against those donors who did not get pregnant.~   "
29474|NCT02671331|"~     The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with~     duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an~     accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric~     Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS~     procedure is safer and easier to perform as it only requires one anastomosis compared to the~     BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic~     comorbidities, including type-2 diabetes mellitus. However, the initial publications of the~     loop DS still resulted in a small number of patients with total protein malnutrition. For~     this reason, the investigators will study the loop DS with a modification of the originally~     published technique with a longer common channel limb (300 cm) to reduce the risk of protein~     malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as~     other bariatric procedures are technically challenging with increased operative risk. A loop~     duodenal switch may be a safer operation with improved weight loss for the super-morbidly~     obese patient.~   "
29475|NCT02671318|"~     Cytomegalovirus is the most important opportunistic infection after kidney transplant, with~     increased in mortality, morbidity and higher costs of transplantation. Despite the favorable~     efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus,~     mycophenolate and prednisone, or the investigators local common regimen, tacrolimus,~     azathioprine and prednisone, this combinations are associated with higher incidence of~     cytomegalovirus infection, disease and recurrence.~      Namely, sirolimus use is associated with decreased risk of cytomegalovirus~     infection/disease, and there is not a prospective cohort to evaluate the conversion to~     sirolimus efficacy to decrease the cytomegalovirus infection recurrence.~      Given this, the investigators propose a study of their own initiative that attends local~     needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus~     recurrence after kidney transplant.~   "
29476|NCT02671305|"~     Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the~     placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes~     (in particular reduction of intraventricular hemorrhage all grade). The placental~     transfusion strategies performed in preterm babies at delivery have been delayed cord~     clamping and cord milking. Both experimental strategies do not explore the contribution of~     the start of breathing on placental transfusion, as performed in a small time frame (30-60~     seconds for delayed clamping and less than 20 sec for cord milking). To assist the newborn~     bedside near to the delivering mother, leaving the cord unclamped, would allow to explore~     the contribution of breathing,both spontaneously started or assisted by initial steps in~     stabilization, on early postnatal adaptation.~      The purpose of the present study is to assess the feasibility of a large multicentre trial,~     whose primary outcome is the reduction of the composite outcome of severe intraventricular~     hemorrhage, chronic lung disease or mortality in babies assisted bedside with placental~     circulation intact for 3 minutes.~   "
29549|NCT02670343|"~     An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a~     single study site. Each study participant received a single oral TU dose immediately prior~     to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of~     fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and~     post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.~   "
29477|NCT02671292|"~     To determine whether reducing loss of control eating (LOC) with Interpersonal~     Psychotherapy-Weight Gain (IPT-WG) will be effective for adolescent military-dependents who~     report such behavior. The investigators will examine whether IPT-WG influences body weight~     gain trajectories and prevents worsening disordered eating, psychosocial problems, and~     metabolic functioning among military dependents at heightened risk for adult obesity and~     disordered eating. This study will provide key efficacy data for a new promising obesity~     prevention program for youth from military families.~   "
29478|NCT02671279|"~     This is a prospective study of morbidly obese patients that are planned to conduct bariatric~     surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior~     to the operation and be admitted to hospital for this period. On admission and after~     finishing the diet a number of tests will be performed: Weigh, height, oral glucose~     tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of~     subcutaneous adipose tissue.~   "
29479|NCT02671266|"~     The purpose of the current study is to investigate the effect of an acute administration of~     intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals~     with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy~     controls.~   "
29480|NCT02671253|"~     This project focuses on myomectomy patients in reproductive age. The aim is to study both~     the molecular characteristics of uterine fibroids and to characterize the clinical effects~     of surgical treatment.~      Patient series is mainly retrospective and consists of individuals who have undergone~     myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the~     investigators have started a prospective sample collection starting in October 2015,~     collecting samples from myomectomies.~      Clinical data sources include medical records, specific questionnaires and a quality of life~     -questionnaire filled by patients.~   "
29481|NCT02671240|"~     Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's~     disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid~     syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the~     drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist)~     anxiously including apathy.~      Our goal is to describe the natural history of Behavioral Addiction under the effect of the~     evolution of the disease and adapt treatment according to the prior art, through a study of~     a larger population of patients than in the few published studies.~   "
29482|NCT02671227|"~     The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg~     sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative~     pain in gynecologic laparoscopic surgeries.~   "
29483|NCT02671214|"~     Identify one or more flat bread mixes that produce a reduction in positive incremental area~     under the curve (iAUC) of post-prandial glucose relative to the control product.~   "
29484|NCT02671201|"~     Emergency ultrasound examinations are increasingly important diagnostic tools in emergency~     and critical care medicine. This study wants to analyze different types of education for~     undergraduate students. Any method of medical training will be proved theoretical and in~     clinical practice.~   "
29485|NCT02671188|"~     Chemokine (C-C motif) ligand 20 (CCL20) is a protein involved in attracting immune cells~     including subsets of T cells (for example Th17 cells), B cells, natural killer cells and~     dendritic cells to inflamed tissues in conditions such as psoriasis (Ps) and psoriatic~     arthritis (PsA). CCL20 acts by binding and activating the chemokine receptor 6 (CCR6)~     present on the surface of the inflammatory cells. Levels of CCL20 are increased in inflamed~     tissues in psoriasis (Ps) and inflammatory arthritis. GSK3050002 is a humanized~     Immunoglobulin G (Ig)G monoclonal antibody, which binds to and neutralizes the action of~     human CCL20. The hypothesis is that GSK3050002 will reduce the movement of inflammatory~     cells into tissues affected by Ps or PsA, thereby leading to an improvement in disease~     activity. The primary objective of this multi-centre, randomized, double-blind (sponsor~     open), placebo-controlled trial is to evaluate the safety and tolerability of repeat doses~     of GSK3050002, and to understand the mechanism of action (by taking skin and synovial biopsy~     samples) and potential for clinical efficacy of GSK3050002 in subjects with PsA. A minimum~     of 18 subjects and up to a maximum of 30 subjects will be randomised into the study to~     either GSK3050002 or placebo in a 2:1 ratio to ensure that approximately 18 evaluable~     subjects complete the study. The total duration of participation in the study will be~     approximately 21 weeks from screening to last study visit.~   "
29486|NCT02671175|"~     This study evaluates the efficacy and safety of 3 months of malaria chemoprevention~     post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age~     admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.~   "
29487|NCT02671162|"~     The purpose of this study is to determine whether Fumaria Parviflora L. can minimize~     severity of pruritus in patients with end-stage renal disease.~   "
29488|NCT02671149|"~     The aim of this study is to determine whether drinking plain water when mildly dehydrated~     benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed~     to result in minor dehydration. While some participants receive two 150ml drinks of water~     others do not. Differences in cognitive functioning are assessed.~   "
29499|NCT02671006|"~     A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for~     monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells /~     basophils without any identified cause. It is considered that Mast cell/basophil have an~     abnormally high sensitivity in CU and can be triggered with almost nothing (high~     irritability). In allergy, basophils degranulation can be reproduced in vitro with~     allergens. Anti-IgE (immunoglobulin E) antibody mimics allergen triggering of basophils in a~     dose dependent manner. If basophils are abnormally sensitive in CU, it should be reproduced~     in vitro at very low stimulation. The main objective of this project is to set up a method~     to evidence abnormal basophil irritability and look for clinical significance. As many~     markers characterize basophils in different states, researchers shall also look for a~     profile possibly associated with CU basophile irritability. Such tests could be useful in CU~     monitoring.~   "
29550|NCT02670330|"~     The aim is to assess the long-term safety of topical use of ZORBLISA in patients with~     Epidemolysis Bullosa.~   "
29489|NCT02671136|"~     Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans.~     Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated~     inflammation can increase insulin resistance in Diabetics and worsens the condition.~     Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome~     in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome~     between 2 main diabetic type 2 patient groups receiving medical care treatment: either~     Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at~     LLU Health.~      24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis~     will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical~     needs.~      For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use~     history, BMI, current medication list) and oral health habits will be obtained. Blood~     samples for HbA1c determinations, clinical periodontal measurements (plaque index, probing~     measurements including pocket depth, attachment levels, gingival index and~     bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end~     of the study. Subgingival microbial samples will be collected from three randomly selected~     sites and analyzed for detection of about 300 of the most prevalent oral bacterial species.~     Differences in periodontal clinical outcomes and bacterial profiles will be identified~     utilizing ANCOVA (Analysis of Covariance).~   "
29490|NCT02671123|"~     The purpose of this study is to determine whether co-registration of OCT and angiography~     reduce geographic miss defined as stent edge dissection or significant residual stenosis at~     stent edge after stent implantation during percutaneous coronary intervention.~   "
29491|NCT02671110|"~     This study compared the recently developed Transforming Your Life (TYL) weight loss program~     to the Diabetes Prevention Program (DPP), considered the Gold Standard in behavioral~     weight loss treatment.~   "
29492|NCT02671097|"~     Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin~     pharmacokinetics.~      PK of BAY1841788 (ODM-201) after single and repeated administration in male and female~     subjects.~   "
29493|NCT02671084|"~     Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can~     represents a problem to the patients resulting in increase of morbidity and mortality.~      Patients submitted of coronary angioplasty procedures can release in varying degrees of~     creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.~      Possibly patients who will receive sevoflurane experience a higher level of cardiac cell~     protection with lower incidence in the release of CK - MB values in excess of 100% baseline.~   "
29494|NCT02671071|"~     The primary objective of this study is to describe the socio-demographic, clinical~     pathological, quality of life and treatment characteristics of patients diagnosed with CC in~     Brazil.~   "
29495|NCT02671058|"~     This study will be an open label, single dose, randomized, 2 way (2 period) crossover study~     in healthy adult subjects at a single study center.~   "
29496|NCT02671045|"~     Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional~     cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver~     mutations, which when targeted with specific therapies, experience improved outcomes.~      Unfortunately, identification of these mutations, although recommended in national~     guidelines, has been limited for a variety of factors including small biopsy samples. The~     broad application of a sensitive genomic profiling test, which simultaneously examines for~     multiple genomic alterations on limited biopsy material, could increase the identification~     of patients with actionable mutations and thereby improve survival in NSCLC. The~     FoundationOne test meets these requirements. A recent study using the FoundationOne assay~     identified a significant number of actionable mutations among NSCLC patients who were~     previously thought to be negative for mutations when tested using other approaches.~      This is a non-randomized observational comparative study with various cohorts based on~     physician diagnostic patterns of care and biologic genomic profile status. Survival and cost~     information will be compared based on different use of genomic profiling.~   "
29497|NCT02671032|"~     The purpose of the feasibility study is to examine audiological outcomes (audiometry and~     speech perception) and safety (adverse events and adverse device effects) with the Nucleus~     CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for~     cochlear implantation.~   "
29498|NCT02671019|"~     The purpose of this trial is to compare the effectiveness and costs of a five-module~     Internet-based treatment program (including therapist support) for harmful alcohol use with~     the effectiveness and cost of the same treatment content delivered face-to-face in~     specialized addiction treatment. The hypotheses to be tested through this trial are that:~        1. The Internet-based treatment program (including therapist support) is as effective~          (reducing alcohol consumption) as the same treatment content delivered face-to-face in~          specialized addiction treatment.~        2. The Internet-based treatment program (including therapist support) is associated with~          lower cost per treated individual in relation to the achieved effects (in terms of~          reduced alcohol consumption) compared with the same treatment content delivered~          face-to-face in specialized addiction treatment.~      The design is a two-armed randomized controlled trial, and outcomes are measured in terms of~     changes in alcohol consumption, problematic alcohol use as well as alcohol dependence,~     depression, anxiety, quality of life and costs for the treatments. A minimum of 350~     participants will be recruited and randomized into two groups:~      Intervention group 1: All participants in this group will have access to the five-module~     Internet-based treatment program for harmful alcohol use and have access to a therapist with~     training in psychotherapy (CBT) who assists and counsels the participant throughout the~     program.~      Intervention group 2: All participants in this group will attend five face-to-face treatment~     sessions in specialized addiction treatment.~   "
29500|NCT02670993|"~     Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns~     essentially 65 years old and older patients. Antalgic and psychotropic treatments have~     adverse effects in old people, and have to be used carefully. To improve the pain support~     and limit the drug consumption, it is possible to perform therapies without drugs. Among~     them, musical intervention represents an interesting complementary support, to deal with~     physical and moral pain in AD.~   "
43355|NCT02489513|"~     The study is designed to characterize the absorption, metabolism, and excretion of AG-120~     using radiolabeled drug in healthy adult male subjects to support its further development~     and registration.~   "
29501|NCT02670980|"~     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System~     (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or~     Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects~     undergo ophthalmological examinations in predefined intervals after implantation.~     Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse~     events are recorded and analyzed. Efficacy is measured using functional vision and visual~     function tests before and after implantation as well as with the system on and system off.~   "
29502|NCT02670967|"~     The present study conducted a meta-analysis of 22 randomly controlled trials to assess the~     effects of soluble fiber intake on blood pressure in human subjects.~      Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and~     meta-analysis was conducted. Information regarding study methods, characteristics, mean BP~     and standard deviations were extracted The data from each study were pooled using a random~     effects model to estimate the effects of soluble fiber consumption on blood pressure.~   "
29503|NCT02670954|"~     To evaluate the efficacy and safety of appropriate postoperative sedation with~     dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled~     study was conducted among patients after abdominal surgeries began in October 2015.The~     investigators enroll patients who received abdominal surgeries. One group receive sedative~     along with analgesic and the other group analgesic only for the other group on the first 24~     hours after surgeries and will follow up for 3 days.~   "
29504|NCT02670941|"~     The rationale behind the proposed study is to determine the initial effectiveness of~     aromatherapy in relief of commonly reported symptoms in cancer patients undergoing~     chemotherapy.~   "
29505|NCT02670928|"~     This study aims achieving of long-term weight loss in T2DM patients by use of comprehensive~     lifestyle changes program, providing patients with structured diet, exercise plan, group~     behavioral support and group education. Additionally the study is designed to establish~     reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and~     can also reduce blood pressure level. The study is also directed to show that lifestyle~     changes program in T2DM patients can lead to decreasing of hospitalization rate and~     healthcare consumption. In order to demonstrate a change from standard of care, data will be~     collected from a parallel cohort from the same centers.~   "
29506|NCT02670915|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety~     of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin~     degludec in children and adolescents with type 1 diabetes.~   "
29507|NCT02670902|"~     This research uses a multi-phase approach to adapt and implement an established~     intervention, Critical Time Intervention, for a new population and setting among individuals~     with co-occurring substance use and mental health problems who are at risk of relapse~     following residential substance abuse treatment. The goals of the study are to: (PHASE 1)~     identify challenges and strategies of community reentry among individuals with co-occurring~     problems in residential substance abuse treatment and their providers and social support~     networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals~     with co-occurring disorders in residential substance abuse treatment to prepare them for~     discharge and transition back into the community; and (PHASE 3) conduct a pilot study to~     examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared~     to enhanced usual discharge planning services.~   "
29508|NCT02670889|"~     The purpose of this study is to determine if acetohydroxamic acid (AHA) can prevent~     hydrolysis of urea by inhibiting the bacterial urease of gut flora of both healthy control~     adults as well as adults with urea cycle disorders.~   "
29509|NCT02670876|"~     The investigators recruited school bullying perpetrators from the age of 12 to 17 by~     referral from the local police department. An anti-bullying intervention based on~     cognitive-behavioral therapy (CBT) principles was conducted, and addressed issues related to~     impulse control, empathy and communication enhancement. All participants completed brain~     magnetic resonance imaging, neurocognitive tests, and questionnaires before and after the~     intervention.~   "
29510|NCT02670863|"~     The purpose of this study is to evaluate the safety and efficacy of the experimental formula~     supplemented with a prebiotic vs the control formula.~   "
29511|NCT02670850|"~     Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more~     severe than can be explained by an individual's age and education. One study in the United~     States found that MCI caregivers have experienced distress in association with caregiver~     burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%.~     Understanding the process of family caregiving provides a knowledge base for the health~     professionals when developing effective interventions. However, little is known about the~     phenomenon of family caregiving to patients with MCI in Taiwan.~      Therefore, the purpose of the proposed study is to develop a theoretical model and a~     model-based intervention program for family caregivers of patients with MCI in Taiwan, and~     pilot test it in a clinical trial.~   "
29512|NCT02670837|"~     Few but persistent wounds often remain even after successful hematopoietic cell~     transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators~     propose local wound therapy using epidermal skin grafting from the same donor that provided~     the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene~     corrected) skin. In both cases permissive immune system and skin chimerism is expected to~     enable long-term epidermal engraftment and wound healing. The investigators will use FDA~     approved vacuum device (CelluTome®, Regulation number 878.4820) that enables painless,~     bloodless and scar-free harvesting of epidermis and its transfer on a square of surgical~     tape (Tegaderm®) to the recipient as a wound dressing.~   "
29513|NCT02670824|"~     This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single~     escalating dose and repeated doses of CN-105 in healthy adult participants. There will be~     about 48 subjects, 36 active and 12 placebo.~   "
29514|NCT02670811|"~     The objective of the present work was to evaluate the antihypertensive effect associated~     with the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on~     prehypertensive subjects.~   "
29551|NCT02670317|"~     This is a prospective, multicenter, single arm, phase II trial in young patients (18-60~     years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma~     (DLBCL).~      Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with~     ibrutinib.~   "
29515|NCT02670798|"~     The long-term goal of this study is to optimize the perioperative care of pediatric spinal~     deformity patients, minimizing perioperative complications and increasing cost-effectiveness~     of perioperative hematologic management. The objective of the proposed study, which is the~     initial step in pursuit of this goal, is to evaluate the effectiveness of~     thromboelastography (TEG) to monitor coagulation pathways and direct blood product~     replacement in pediatric neuromuscular spinal deformity surgery. The central hypothesis of~     this study is that TEG will decrease exposure to allogeneic packed red blood cells (PRBC).~     The rationale is that proven effectiveness of TEG in neuromuscular deformity may change the~     standard of care for hematologic management in neuromuscular spinal deformity cases and~     additionally set the stage for a multicenter trial in idiopathic pediatric deformity.~   "
29516|NCT02670785|"~     This study will access the safety and efficacy of three doses of estradiol vaginal capsules~     in postmenopausal women with vulvovaginal atrophy.~   "
29517|NCT02670772|"~     The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior~     (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV~     treatment.~   "
29518|NCT02670759|"~     This study is designed to assess:~        -  The impact of continuous thoracic paravertebral nerve blockade compared to intercostal~          nerve blockade on the intensity of postoperative pain following VATS in subjects having~          a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.~        -  The impact of continuous thoracic paravertebral analgesia on length of stay, opioid~          intake, respiratory function, incidence of side-effects and postoperative~          complications.~      The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade~     will provide superior postoperative analgesia following VATS when compared to intercostal~     nerve blockade in patients having a PCA device as their primary analgesic modality. Superior~     quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake~     and related side-effects and shorten the hospital stay.~   "
29519|NCT02670746|"~     The objective of the study is to prospectively assess the use and treatment outcomes of~     nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands.~     Additional objectives are to monitor the incidence and reversibility of neuropathy during~     treatment, to assess the patient's Quality of life when treated with~     nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating~     metastatic pancreatic cancer.~   "
29520|NCT02670733|"~     There are concerns that the use of positive end-expiratory pressure (PEEP) for the treatment~     of pulmonary complications in patients with brain injury may potentially elevate~     intracranial pressure (ICP), and deteriorate neurological status. It is suggested that both~     respiratory system compliance and ventricular compliance would contribute to the elevation~     of ICP when PEEP increases. In theory, PEEP may cause elevation of ICP by increasing~     intrathoracic pressure and diminish venous return. However, the transmission of PEEP into~     thoracic cavity depends on the properties of the lung and chest wall. Experimental study~     showed that when chest wall compliance is low, PEEP can significantly increases~     intrathoracic pressure; whereas low lung compliance can minimize airway pressure~     transmission. It is generally recognized that the lung compliance decreases in acute~     respiratory distress syndrome (ARDS) patients due to extensive alveolar collapse. However,~     it has been report that the elastance ratio (the ratio between elastance of the chest wall~     and the respiratory system, where elastance is the reciprocal of compliance) may vary from~     0.2 to 0.8. Therefore, it is important to distinguish the compliance of the chest wall and~     the lung when investigating the effect of PEEP on ICP.~      Because intrathoracic pressure (pleural pressure) is difficult to measure in clinical~     situations, esophageal pressure (Pes) is considered as a surrogate of intrathoracic~     pressure. In the present study, the investigators determine the effect of PEEP on~     intrathoracic pressure and ICP by Pes measurement.~   "
29521|NCT02670720|"~     This is an open-label study designed to evaluate the long-term safety of prophylactic~     avoralstat (500 mg three times daily) when given to approximately 150 patients with~     hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate~     the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.~   "
29522|NCT02670707|"~     Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause~     lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a~     cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes~     there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF~     gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells~     to build up in certain parts of the body, where they can damage tissue or form lesions.~      For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line~     therapy while cytarabine therapy has been used as therapy for patients who develop~     recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.~      The purpose of this research study is to compare previously used vinblastine/prednisone to~     single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study~     called a positron emission tomography (PET) scan to more accurately assess areas of LCH~     involvement not otherwise seen in other imaging studies as well as response to therapy. We~     also want to identify if genetic and other biomarkers (special proteins in patient's blood~     and in patient's cancer) relate to the response of patients LCH to study treatment.~   "
29523|NCT02670694|"~     This study will investigate sleep behavior in subjects with Angelman Syndrome, Rett Syndrome~     or Prader-Willi Syndrome.~      The study will also investigate sleep behavior in healthy siblings of subjects with Angelman~     Syndrome, Rett Syndrome or Prader-Willi Syndrome. These individuals will serve as control~     subjects.~      The study will use questionnaires designed to identify sleep disorders and how they affect~     behavior and quality of life.~      The principal goals of this study are:~        1. To see how common sleep disorders are in individuals with Angelman Syndrome, Rett~          Syndrome or Prader-Willi Syndrome;~        2. To see how sleep disorders affect behavior in these individuals;~        3. To see whether sleep disorders and related behavior problems improve or worsen with~          age;~        4. To see how specific disease conditions relate to sleep disorders and how bad the sleep~          disorders are;~        5. To develop new treatment options to improve quality of life and behavior issues; and~        6. To evaluate current treatment options to improve sleep problems in these individuals.~   "
29524|NCT02670681|"~     The aim of this intervention study is to evaluate the acute and chronic effects of different~     intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels~     of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40~     to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in~     acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and~     session control. After, the subjects will be randomly allocated into four intervention~     groups: mild intensity group, moderate intensity group, high intensity group and control~     group. In both phases, the subjects have blood pressure data recorded by ambulatory blood~     pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be~     registered biological signs of blood pressure (finometer), electrocardiogram (DII~     derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac~     autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator~     response and peripheral vascular resistance.~   "
29525|NCT02670668|"~     The study is to determine the prevalence of potential chemo-response related genes mutation~     in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate~     potential relationship between these gene mutations and NAC-response in TNBC patients.Based~     on the results,we can further characterize TNBC from a phenotypical and molecular~     perspective, in order to identify potential new target agents and to individualize the~     treatment.~   "
29526|NCT02670655|"~     Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic~     species across membranes and may have significant benefit for the treatment of actinic~     keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).~   "
29527|NCT02670642|"~     The purpose of this study is to compare on demand with continuous treatment of endoscopy~     negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once~     daily, with regards to willingness to continue in the study as a result of satisfactory~     treatment over a six-month long term management period, after initial symptom relief.~   "
29528|NCT02670629|"~     This fractures have been managed with anatomical reduction performed under anesthesia or~     using sedatives. In our institution this means prolonged hospital stay, involvement of an~     anesthesiologist and the use of an special room in the Emergency Department. This research~     protocol was born after reports were published regarding leaving the fractures in an~     overriding position and cast with good functional and acceptable radiographical results;~     said study was observational, providing valuable but limited information about this~     treatment option. On the other hand, our study is a randomized controlled trial between to~     groups of patients younger than 11 years old who presented to the Emergency Department with~     completely displaced distal radius fractures, they were randomly assigned to one of two~     groups, either a closed anatomic reduction and short cast or a closed overriding alignment~     and short cast.~   "
29529|NCT02670616|"~     EBV-positive diffuse large B-cell lymphoma has EBV-mediated oncogenic signaling pathway~     activation, and these multiple intracellular pathway can be potential therapeutic target in~     this disorder. Thus, EBV-associated protein, LMP1 can induce the activation of various~     downstream pathway molecules such as PI3K/Akt and NF-kB activation. The activation of NF-kB~     is one of essential factors contributing to prolonged survival and aggressive phenotype of~     diffuse large B-cell lymphoma. In a more aggressive subtype of diffuse large B-cell~     lymphoma, activated B-cell like type, chronic active B-cell receptor signaling and MYD88~     mutation are known to stimulate NF-kB transcription and activation. As a result, a key~     molecule mediating B-cell receptor signaling pathway, Bruton tyrosine kinase (BTK) can have~     a critical role, and BTK has been emerging as a therapeutic target in diffuse large B-cell~     lymphoma. Considering the close association between B-cell receptor signaling pathway and~     PI3K/Akt pathway in diffuse large B-cell lymphoma, targeting BTK might be helpful for~     improving treatment outcome of EBV-positive diffuse large B-cell lymphoma.~      Ibrutinib, BTK inhibitor has an activity against B-cell non-Hodgkin lymphoma via targeting~     on B-cell receptor signaling pathway. As a result, the evidence of antitumor- effect of~     Ibrutinib has been accumulated in several types of B-cell lymphoma such as mantle cell~     lymphoma. Given EBV-positive diffuse large B-cell lymphoma is known as having poor response~     to treatment compared to diffuse large B-cell lymphoma, not otherwise specified (NOS), the~     addition of ibrutinib to standard chemotherapy regimen, rituximab-CHOP may provide benefit~     these patients.~   "
29530|NCT02670603|"~     This study is a prospective randomized controlled study of EVONAIL® solution for prevention~     or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.~   "
29531|NCT02670590|"~     Investigators perform a counseling intervention study (6 months) in adult subjects with~     evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS);~     exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90~     ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus~     hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model~     assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual healthy~     food purchase, storage, and cooking were given. Reliable feedback and evidence of patients'~     adherence were obtained by scheduled dietician's interviews. Investigators will challenge~     the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile~     score and of increased physical activity at 6 months in a body mass index changes-balanced~     model to detect independent effects, if any, of the studied variable on NAFLD persistence,~     amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary~     profile score will be calculated by contingency tables and receiver operator characteristic~     curve (ROC) analysis..~   "
29532|NCT02670577|"~     The scope of this study is to measure the impact of MammaPrint on treatment in Hormone~     Receptor (HR)-positive HER2-negative breast cancer patients.~      In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up~     to 1 node), Triple Negative or HER2-positive tumors will be assessed.~   "
29548|NCT02670356|"~     Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in~     fish oil and in krill oil. The purpose of this study is to compare the effects of the~     recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg~     - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300~     mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and~     inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.~   "
29533|NCT02670564|"~     Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient~     genetic variations which influence activity of enzyme metabolizing or acting in the pathway~     of prescribed chemotherapy drugs.~      This add-on research aims to prospectively investigate variations in several candidate genes~     related to all types of chemotherapeutic drugs and TBI used in the main related study NCT~     01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK~     variability and outcome of myeloablative therapy for pediatric patients receiving an~     allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.~   "
29534|NCT02670551|"~     This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 mg/day or 3~     mg/day compared to placebo for treatment of the depressive episode in patients with bipolar~     I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.~   "
29535|NCT02670538|"~     This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of~     cariprazine 1.5 mg/day or 3 mg/day compared to placebo for treatment of the depressive~     episode in patients with bipolar I disorder. The safety and tolerability of the fixed-dose~     regimens will be evaluated.~   "
29536|NCT02670525|"~     This research study is seeking to gain new knowledge about Recurrent, Refractory, or High~     Risk Leukemias in children and young adults.~      This study is evaluating the use of specialized testing called leukemia profiling. Once the~     profiling is performed, the results are evaluated by an expert panel of physicians,~     scientists and pharmacists. This may result in a recommendation for a specific cancer~     therapy or a clinical trial called matched targeted therapy (MTT). The results of the~     leukemia profiling and, if applicable, the MTT recommendation will be communicated to the~     participant's primary oncologist.~   "
29537|NCT02670512|"~     Compared to hemodialysis, patients on peritoneal dialysis live longer and healthier, have a~     higher quality of life and cost approximately $40,000 less to the healthcare system per~     patient per year. However, only 18% of dialysis patients in Canada currently use peritoneal~     dialysis because patients often feel isolated from the healthcare team and lack the~     confidence to manage treatments by themselves. This study will assess a telehome monitoring~     system (eQ Connect™), allowing for up-to-date data transmission and digital interaction~     between the patients at home and their healthcare team. From the patients' perspective, this~     technology is an easier way to communicate with their healthcare providers, track their~     treatment and supplies, and receive training and support. From the providers' perspective,~     eQ Connect™ delivers up-to-date patient data and provides an efficient way to keep track of~     the patients' progress. This intervention has the potential to improve the patients'~     clinical outcomes, quality of life, reduce the costs of dialysis to the healthcare system~     and ultimately empower patients to start and stay on peritoneal dialysis.~   "
29538|NCT02670499|"~     Post Market TKR study~   "
29539|NCT02670486|"~     Many women have the need to run to the restroom frequently during the night and day, a~     condition called overactive bladder. Embarrassing urinary leakage is also commonly~     associated with these symptoms. The investigators believe the primary cause in most cases is~     the bladder muscle contracting too frequently but are still not sure exactly why this~     happens and if it is triggered by factors in the environment. When bladder testing using~     pressure catheters (urodynamics) is done these bladder contractions are often not picked~     up, even in women with overactive bladder. This may be partly due to the unnatural~     environment in which the testing is done without the presence of the usual visual or audible~     triggers, such as running water or seeing a toilet. The investigators propose adding an~     audiovisual stimulant to the usual bladder testing to see if this makes it more likely for~     bladder contractions to happen. One group of patients would have the usual bladder testing~     as part of their normal care. The other group would receive the normal care in addition to~     hearing a water fountain in the room and watching a video of things that may trigger~     overactive bladder symptoms; seeing public restroom signs in a mall, a toilet bowl being~     lowered and a kitchen sink with water running over dishes. The suspicion is that the~     proportion of patients in whom bladder contractions are seen will be higher for those with~     audiovisual triggers compared to those with the usual care. Women with overactive bladder or~     leakage with urge who are sent for urodynamics by their doctor will be asked if they wish to~     participate in the study.~   "
29540|NCT02670460|"~     Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter,~     confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony~     with mechanical ventilator breaths.~   "
29541|NCT02670447|"~     Researchers propose in this project to evaluate predictive factors of non response. It is~     defined by the lack of symptomatic remission at month 3, for patients presenting a first~     episode of psychosis. It will be performed on objective markers taken from imagery~     techniques. The link between evolution of these markers and clinical measures will be~     studied.~   "
29542|NCT02670434|"~     The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo®~     on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary~     hyperlipidemia or mixed dyslipidemia~   "
29543|NCT02670421|"~     Will the intervention (Heart SMART program) be feasible in moderate or high stress patients,~     who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?~   "
29544|NCT02670408|"~     Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care~     for heart transplant patients.~   "
29545|NCT02670395|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of~     JNJ-54416076 when co administered with food compared to administration in fasting condition~     (in Part 2).~   "
29546|NCT02670382|"~     The objective of this study is to provide critical information regarding both common and~     distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.~   "
29547|NCT02670369|"~     The investigators are doing a study to learn how to support patients aged 60+ in taking more~     breaks from sitting. The goal of the study is to find out if using commercially available~     devices are helpful in reducing sitting time.~   "
29552|NCT02670304|"~     Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in~     luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as~     one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.~   "
29553|NCT02670291|"~     This randomized, sham-controlled, double blind, multicentre clinical trial aims at providing~     evidence for the efficacy and safety of continuous theta burst stimulation (cTBS) in the~     treatment of auditory hallucinations in patients with schizophrenia. Overall, the study will~     include 86 patients. Each patient will receive a three weeks course of daily (5/week)~     treatment; 50% of the patients will be treated with cTBS (1200 impulses daily), the other~     half with a sham stimulation to the left and right temporoparietal cortex. Sham stimulation~     will be applied by an active sham-coil that allows for a double-blind treatment. Follow-up~     assessments 1, 3 and 6 months after treatment will investigate the stability of treatment~     effects.~   "
29554|NCT02670278|"~     It is well-known that breastfeeding protects infants from illness, especially in the poorest~     regions of the world. The full nature of this protective effect, however, is less well~     understood. A major barrier to understanding is the fact that almost nothing is known about~     the factors that influence the considerable variation in milk composition around the globe,~     or about the effects of this variation on infant health. This INSPIRE project represents the~     first comprehensive investigation of the global differences in human milk composition along~     with the various microbial, evolutionary, environmental, and sociocultural factors that~     might influence both milk composition and infant health. An international, interdisciplinary~     collaboration of physiologists, nutritional scientists, anthropologists, microbiologists,~     and mathematicians will collect biological data from breastfeeding women and their infants,~     in concert with extensive anthropologic and ecological data, in both developed (US, Spain,~     Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya).~     To test the possibility of a correlation between milk oligosaccharide composition, milk~     microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal~     samples will be analyzed using state-of-the-art biochemical and genomic techniques. This~     study will allow important cross-cultural comparisons of milk composition and infant feeding~     practices; it also will utilize sophisticated computational methods to integrate the~     extensive, diverse body of combined biological and anthropological data to elucidate the~     relationships among sociocultural factors, evolutionary history, environmental exposures,~     microbial constituents and milk composition. The researchers predict that what is considered~     normal milk composition in one population may not support optimal health in another. This~     information is crucial to the humanitarian quest to understand how infant nutrition and~     overall health can be improved around the world. In addition, this project will provide~     extensive research training opportunities for undergraduate, graduate and postdoctoral~     scientists.~   "
29555|NCT02670265|"~     Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many~     procedures for diagnostic workup that require fasting periods. In a prospective randomized~     monocentric study we evaluate the effect of additional parenteral nutrition on weight loss,~     nutritional status, quality of life and length of hospital stay.~   "
29556|NCT02670252|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice~     between BU-based or TBI-based conditioning regimens still remains controversial. In this~     study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in~     patients undergoing allo-HSCT for ALL in CR1 are evaluated.~   "
29557|NCT02670239|"~     Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk~     donor lungs that would otherwise be rejected for transplantation mainly due to the presence~     of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK)~     of several drugs including antibiotics, thus exposing patients to risk of therapeutic~     failure or drug toxicity. The investigators set out to examine the concentration of imipenem~     in lung perfusate and in lung biopsy during EVLP, and its clinical impact.~   "
29558|NCT02670226|"~     The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to~     diagnosis. The second objective is to better understand the pathogenesis of this disease by~     the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.~   "
29559|NCT02670213|"~     This study is conducted in Asia. Tha aim of this study is to investigate Safety and~     Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in~     Japan.~   "
29560|NCT02670200|"~     Cancer patients develop a high psychological burden of the underlying disease. To support~     patients in outpatient phases psychotherapists are not sufficiently available for establish~     regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support~     can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet~     (called Incobeth®) in cancer patients.~   "
29561|NCT02670187|"~     The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute~     respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe~     pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600~     individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine~     that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of~     GLS-5300 at one of three dose levels following a three-injection vaccination regimen~     followed by electroporation. The study will also assess immune responses over a 1 year~     period with respect to the generation of antibody and cellular responses.~   "
29562|NCT02670174|"~     A randomized controlled trial will be conducted to examine the effectiveness of a~     traditional home exercise program versus an kinetic chain home exercise program on treatment~     outcome of overhead athletes with shoulder impingement syndrome. Primary outcome measures~     are reduction of pain and disability, and improvement in functionality and sports~     performance. Secondary outcome measures are strength, mobility, flexibility and functional~     performance.~   "
29563|NCT02670161|"~     The investigators will conduct at NorthShore University HealthSystem pragmatic trials using~     the EMR for 10 common neurological disorders. They will demonstrate the feasibility of~     subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data~     capture at the point of care using the EMR. They will identify the most effective treatments~     for common neurological disorders and seek replication by the NPBRN.~   "
29564|NCT02670148|"~     This study is a randomized controlled trial designed to compare the effects of 4 weeks of~     chiropractic care to a waitlist control group on measures of strength, balance, and~     endurance in military personnel experiencing non-surgical low back pain.~   "
29565|NCT02670135|"~     This is a single center, double blinded, randomized, controlled trial. Qualified subjects~     will be enrolled and randomized to either one of the two study groups: a) using 0.3%~     triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice~     (copolymer/fluoride/no triclosan) twice daily.~   "
29751|NCT02667678|"~     The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for~     patients infected by HIV with failure in renal function at year 5. The main criterion will~     be a degradation of the glomerular filtration throughput measured. It will be compared to~     clinical scores of degradation risks of renal function for patients infected with HIV.~   "
29566|NCT02670122|"~     This is an observational, multicenter, single arm, prospective study to evaluate safety and~     tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial~     chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to~     150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).~      The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads~     with larger volumes without increasing the risk and complications of DEB-TACE.~   "
29567|NCT02670109|"~     Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express~     estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is~     approximately 180,000 cases per year. TNBC are known to be more aggressive with poor~     prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant~     chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence~     occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for~     these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the~     usage of higher doses of chemotherapy, which results in higher cellular destruction with a~     decrease of hematological toxicity, it is proposed that this procedure is able to improve~     prognosis in TNBC patients with no pathologic complete response after neoadjuvant~     chemotherapy.~   "
29568|NCT02670096|"~     This is a single center pilot study evaluating the immediate effects of low-dose~     acetazolamide on respiratory control in subjects with treatment emergent sleep disordered~     breathing. The purpose of this study is to assess the immediate effect one-time low-dose~     acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA~     subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will~     also try to determine the immediate effect of one-time low-dose acetazolamide on subjects'~     resting ventilation and ventilatory response slope compared to subjects' baseline evaluation~     without acetazolamide.~   "
29569|NCT02670083|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.~     Participants will be randomized 1:1 to receive either intravenous (IV) infusion of~     crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety~     assessment will be performed 52 weeks after the last crenezumab dose.~   "
29570|NCT02670070|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations~     of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone~     in healthy male volunteers.~   "
29571|NCT02670057|"~     The purpose of this open label pilot study is to evaluate the utility of sphenopalatine~     ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.~   "
29572|NCT02670044|"~     The primary objective for this study is to assess the safety and tolerability as well as~     preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in~     combination with idasanutlin in patients >/= 60 years of age with relapsed or refractory~     acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.~   "
29573|NCT02670031|"~     Hypertension and aortic stenosis are the two leading conditions that cause thickening of the~     heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially~     adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of~     progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using~     cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin~     blood assays are potential markers to detect myocardial fibrosis. Although~     hypertension-related heart disease is very common in Singapore, the significance of~     myocardial fibrosis is not well understood. In this study, the significance of myocardial~     fibrosis in 500 patients with hypertension would be investigated. This will be the largest~     study using state-of-the-art MRI to examine the importance of myocardial fibrosis in~     hypertensive heart disease.~   "
29574|NCT02670018|"~     A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the~     Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl~     Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component~     Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets)~     Administered in Healthy Male Volunteers.~   "
29575|NCT02670005|"~     To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI)~     assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous~     coronary intervention (PCI).~   "
29576|NCT02669992|"~     There are severel problems associated with the closing of a temporary loop-ileostomy after~     surgery for rectal cancer. The purpose of this study is to answer two questions:~        1. The choice of anastomotic method - does it influence the postoperative course?~        2. The use of a prophylactic mesh when closing the stoma site - will there be less~          hernias?~   "
29577|NCT02669979|"~     Today's increase of dentate elderly, many of them dependent, is a challenge, both according~     to the personal daily oral hygiene and dentistry. This is not only an oral problem, as~     research findings point to strong associations between oral and general health, even~     mortality. These findings are especially noticeable in elderly and frail individuals.~      Dental care is usually performed in stationary dental clinics where the patients are~     transported to receive treatment. Dependent elderly dental patients may present many~     obstacles to traditional dental care due to cognitive limitations or dementia, mobility or~     transport problems. An alternative is domiciliary dental care where the dental staff~     performs the treatment by a home visit, in the patients daily living environment. The~     ability to handle personal oral hygiene is often decreased in these patients and left to~     overburdened nursing staff that often also lack sufficient knowledge about oral health care,~     why prophylactic professional oral care is especially important. This type of care can with~     rather simple equipments be performed as domiciliary treatment of good quality, while more~     advanced dental care may present restrictions in the home environment. However, in the~     Swedish dental system with subsidized dental care for dependent and elderly patients, there~     are restrictions for the number of prophylactic oral care treatments. The levels vary in~     different counties and regions. The rationale for this is probably tradition and economy as~     scientific evidence is lacking.~      The aim with this project is to develop domiciliary professional oral care. The researchers~     will compare the effect of different regimens for domiciliary prophylactic professional oral~     care both according to content and frequency. The overall aim is to establish relevant~     recommendations for domiciliary prophylactic professional oral care.~   "
29620|NCT02669420|"~     The majority of second-trimester pregnancy termination performed in the United States are~     performed surgically by dilation and evacuation. The frequency of induction of abortion~     increases as gestational age advances. In the late second trimester and early third~     trimester, induction is the primary method of termination in cases of fetal abnormalities.~     In many other countries, however, induction is the primary method of abortion throughout the~     second trimester~   "
29578|NCT02669966|"~     It is well recognized that a subset of patients who contracts Hepatitis C virus (HCV)~     spontaneously clears the virus. Such individuals are anti-HCV antibody positive, yet HCV RNA~     PCR negative in the blood. While they have not been considered candidates for live kidney~     donation in the past, with the recent availability of novel anti-HCV drugs with >95% cure~     rates, they now represent a potential pool of donor candidates, especially since the risk~     for transmission of HCV to the recipient is extremely low. The investigators goal is to~     demonstrate that live kidney donation from anti-HCV positive, HCV RNA PCR negative~     individuals is safe and carries a negligible risk of viral transmission to the recipient.~   "
29579|NCT02669953|"~     Age-related macular degeneration (AMD) is one of the most common disorders causing visual~     disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the~     central retina. Neovascular AMD (nAMD) affects visual function early in the disease process.~      The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to~     the current routine therapy using aflibercept in eyes with recurrent or persistent nAMD.~      20 patients with recurrent or persistent nAMD, previously treated with intravitreal~     ranibizumab for up to one year will be included in this trial. Patients will be examined in~     monthly intervals over 12 months follow-up.~      Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS~     charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl.~     funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence~     fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography~     (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry~     (MP), as well as Non-invasive OCT based optical angiography (AngioVue).~   "
29580|NCT02669940|"~     This study seeks to assess the effectiveness, patient reported outcomes, work productivity~     and healthcare resource utilization of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) - Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis~     C (CHC) participants in a real life setting across clinical practice populations.~   "
29581|NCT02669927|"~     To find an objective, affordable and manageable way to measure frailty in elderly patients~     and to examine relationship between peri-operative metabolism of frail older people and~     outcome after hip surgery.~   "
29582|NCT02669914|"~     Brain metastases are the most common intracranial malignancy occurring in 20-40% of all~     cancers, and the presence of CNS metastases is associated with a poor prognosis. As such,~     the median overall survival of patients with symptomatic brain lesions is a dismal 2-3~     months regardless of tumor type. Because standard chemotherapy largely does not cross the~     blood brain barrier at a meaningful concentration, standard treatment is limited and usually~     involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole~     brain radiation for multiple lesions. Unfortunately, the median overall survival is only~     improved by about 6 months with this multimodality approach2, and there is a paucity of~     second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are~     often not feasible options due to concern for increasing complications or neurotoxicity,~     respectively. Thus, there is a dire clinical need for additional treatment options for this~     patient population.~      Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown~     clinical efficacy in multiple types of solid tumors. The investigators propose to study the~     efficacy of checkpoint blockade therapy in patients with solid tumors and~     refractory/recurrent brain metastases. The investigators will assess the efficacy of~     MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.~   "
29583|NCT02669901|"~     The purpose of this pilot-study is to to distribute naloxone auto-injector in a Universal~     Precaution manner to patients with opioid substance use disorder. The objectives are to~     decrease the number of fatal and nonfatal overdose deaths, to examine and understand the~     risk factors for serious opioid toxicity and overdose, and to evaluate the unintentional~     opioid overdose risk utilizing an evidence-based screening questionnaire.~   "
29584|NCT02669888|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in~     children. The aims of this project are:~        1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically;~        2. To evaluate the safety of indigo naturalis ointment in treating AD topically;~        3. To investigate whether indigo naturalis ointment treatment is associated with a change~          in total IgE, cytokines, eosinophils, and CRP in patients with AD;~        4. To evaluate whether indigo naturalis ointment treatment improves the quality of life in~          patients with AD.~   "
29585|NCT02669875|"~     Portal hypertension (an increase in blood pressure in the portal vein that carries the blood~     from the intestine and spleen to the liver) underlies most of the serious complications of~     liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis~     evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver~     blood flow.~   "
29586|NCT02669862|"~     This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3~     treatment groups.~   "
29587|NCT02669849|"~     The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with~     Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific~     evaluation of the effects of VX-210 on neurological recovery and daily function after spinal~     cord injury.~   "
29588|NCT02669836|"~     The purpose of this study is to determine whether a posterior fossa decompression or a~     posterior fossa decompression with duraplasty results in better patient outcomes with fewer~     complications and improved quality of life in those who have Chiari malformation type I and~     syringomyelia.~   "
29616|NCT02669472|"~     Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that~     was conducted in 15 subsidized housing complexes to evaluate the efficacy of a~     multicomponent intervention comprised of a year-round, discount, mobile fresh F&V market~     -'Fresh To You' (FTY)- that was paired with a nutrition education component including~     included educational newsletters, campaigns, taste-testings and videos in both English and~     Spanish. The primary aim of the LWVB grant was to study the efficacy of FTY combined with a~     motivational/educational intervention to see if it increased F&V consumption compared to a~     Comparison intervention (attention placebo).~   "
29617|NCT02669459|"~     The purpose of this study is to investigate if imiquimod can be used as a non-invasive~     option in the treatment of residual/recurrent CIN lesions.~   "
29589|NCT02669823|"~     Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate~     clinically. This poses a particular threat in low resource areas, where bBSI is often not~     diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately,~     the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter~     the high mortality rate associated with bBSI, antibiotics are often prescribed without~     microbiological confirmation. Sysmex Company has developed technology that enables the rapid~     diagnosis of malaria using a venous blood sample. In addition algorithms based on~     hematological parameters can be used to monitor disease severity and progression, as well as~     guide further diagnostic testing based on differences seen in these parameters between~     various types of disease. The algorithms have been developed and tested in adult populations~     from different industrialized countries and in one Asian population. However no data are~     available neither from pediatric patients, nor from the sub-Saharan setting where the~     epidemiology of infectious diseases is very different from the tested settings. The~     objective of the study is to: 1) Assess the sensitivity and specificity of the Sysmex~     hematology analyzer based on the new technology to diagnose malaria in subjects older than 3~     months, who present with an acute severe febrile illness in a malaria endemic area in~     sub-Saharan Africa 2) Test and optimize the value of Sysmex analyzers in disease diagnosis~     and monitoring in children older than 5 years and adults, who present with an acute severe~     febrile illness in a malaria endemic region in sub-Saharan Africa, to differentiate between~     severe malaria and bBSI, or a combination of these infections. 3) Explore the value of~     Sysmex analyzers in disease diagnosis and monitoring in children between 3 months and 5~     years of age, who present with an acute severe febrile illness in a malaria endemic region~     in sub-Saharan Africa.~   "
29590|NCT02669810|"~     The main purpose of this phase I/IIB is to evaluate the safety, the tolerance and the first~     efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells~     after automated ex-vivo expansion with the StemXpand machine) in patients with a De Novo~     acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be~     reinjected using a dedicated catheter pushed through the femoral artery up to the left~     ventricle, thus avoiding open chest surgery.~   "
29591|NCT02669797|"~     This childhood obesity randomized controlled trial uses innovative methods, such as video~     feedback and ecological momentary intervention (EMI) to compare a family meals coaching~     intervention to a usual care condition in racially/ethnically diverse children ages 5-7~     years and their families. The intervention utilizes in-home visiting methods targeting~     family meal quantity and quality delivered across a three-phased incremental 18-month period~     compared to obesity prevention messages delivered during well-child visits and monthly~     newsletters.~   "
29592|NCT02669784|"~     Any adult patient age18 and above, scheduled for routine CTA of the chest or chest, abdomen~     and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be~     included in the study. The patient will be administered a low dose of intravenous contrast~     based on the study examination.~   "
29593|NCT02669771|"~     The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in~     patients.~   "
29594|NCT02669758|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     ALKS 3831 in subjects with schizophrenia.~   "
29595|NCT02669745|"~     This study is experimental and will prospectively assess the proportion of patients in the~     two (2) MammaPrint Risk categories in patients of Chinese descent.~   "
29596|NCT02669732|"~     The objective of the study is to evaluate change in insulin secretory capacity in patients~     with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral~     administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In~     addition, safety of this regimen will be examined in this study.~   "
29597|NCT02669719|"~     This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC~     (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in~     patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal~     growth factor receptor).~   "
29598|NCT02669706|"~     The main objective of this study is to assess the safety of administering intravenous (IV)~     pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with~     hematologic malignancies and stem cell transplant recipients. There will also be an~     assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic~     therapy.~   "
29599|NCT02669693|"~     This research is aimed at determining whether the presence of oleuropein in olives (Olea~     europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will~     be required to consume commercially available olives together with white bread, and their~     glycaemic response will be measured. The blood glucose response of bread will be determined~     initially as a control/reference. Food samples and control will be consumed in random order.~      The recent rise in the cases of Diabetes mellitus in both children and adults has raised a~     concern for the need to proffer immediate solutions amongst scientists in the fields of~     medicine food science and nutrition. One of the approaches of reducing postprandial~     hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This~     is potentially achieved through the inhibition of the activities of starch digesting enzymes~     namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such~     as acarbose and miglitol which have been quite efficient in these inhibitory functions but~     not without associated side effects and complications such as liver toxicity, etc, arising~     from to long term usage of such drugs. It therefore becomes imperative for natural~     substitutes from food sources to be explored as better alternatives. At the moment several~     plant foods are under investigation as suitable alternatives, and olives appear to be quite~     promising in this regard. There are quite a few studies that have reported the inhibitory~     activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing~     is very scarce.~      It is expected that the research outcome will be a gateway to the reduction and control of~     the incidence of diabetes mellitus.~   "
29600|NCT02669680|"~     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with~     acute on chronic liver failure (ACLF) who meet inclusion/exclusion criteria.The objective of~     GRAFT-trial is to evaluate efficacy and safety of subcutaneously administered granulocyte~     colony-stimulating factor (G-CSF) in patients with ACLF. All patients will receive standard~     medical care for ACLF according to the guidelines. Patients in the experimental arm~     additional receive subcutaneous injections of G-CSF.~   "
29601|NCT02669667|"~     This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to~     assess the safety and tolerability of MEDI9314 in healthy adult subjects~   "
29618|NCT02669446|"~     This a comparative, open label, parallel group, non interventional study which compares the~     tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges~     containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation~     takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by~     the physician and by the patient in a dairy.~   "
29602|NCT02669654|"~     Background: At present pneumonia and malnutrition have become the leading causes of~     mortality among <5-year-old children in developing countries. World Health Organization~     standard management of severe pneumonia and severe malnutrition requires hospitalization for~     supportive care. As many developing countries including Bangladesh do not have enough~     pediatric hospital beds to accommodate the demand for admission of all children with severe~     pneumonia and malnutrition, Investigators developed alternative treatment option such as~     Day Care Approach, for those children who cannot be hospitalized, but are too sick to be~     managed in the community. After successful Day Care Approach of management of efficacy~     trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct~     an effectiveness trial under real life condition, i.e. within the Health Systems of~     Bangladesh.~      Burden: Pneumonia is the leading cause of mortality in developing countries, being~     responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing~     countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6~     million children dying annually because of Severe Acute Malnutrition & Moderate Acute~     Malnutrition, respectively.~      Objectives: To assess & implement the Day Care Approach of management of severe childhood~     pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into~     existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing~     Treatment.~      Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving~     16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly~     assigned to intervention & control arm. Children with severe pneumonia will be enrolled in~     (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas~     to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day~     care Approach in intervention clusters by involving Comprehensive Reproductive Health~     Centres in urban and Health and Family Welfare Centres in rural areas.~      Outcome variables:~        -  Primary: clinical treatment failure by day 6~        -  Secondary:~           (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost~          effectiveness (iii) Referrals to hospitals (iv) Deaths~   "
29603|NCT02669641|"~     The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in~     patients diagnosed with hepatic steatosis in treatment with combination Silimarin,~     Phyllanthus Niruri and Choline.~   "
29604|NCT02669628|"~     The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol~     sclerotherapy of endometriomas versus conventional surgery.~   "
29605|NCT02669615|"~     This study is a single-center, open-label study of high-dose Melphalan HCl for injection~     (propylene glycol free Melphalan) conducted in 24 patients, who have symptomatic multiple~     myeloma and qualify for ASCT.~      There will be three distinct evaluation periods in this trial: a pretreatment period, a~     study period and a follow-up period.~   "
29606|NCT02669602|"~     Dynamic prospective cohort of Spanish university graduates. The main objective is to~     evaluate the associations between nutrition and lifestyle and chronic diseases.~   "
29607|NCT02669589|"~     The aim of this study is to evaluate the effect of regional citrate anticoagulation within~     the scope of continuous renal replacement (CRRT) in critically ill patients with acute~     kidney injury (AKI) on filter life span and 90-day all cause mortality.~   "
29608|NCT02669576|"~     This randomized controlled trial aims to investigate the effectiveness of a mind body day~     care clinic program of breast cancer patients undergoing endocrine therapy.~   "
29609|NCT02669563|"~     The main goal of this study is to test two new radioactive drugs,~     4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG) and~     3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in human subjects with~     congestive heart failure.~      Evaluations of these imaging agents will include their uptake in heart, lungs and liver,~     their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies,~     the better of the two drugs will be chosen for further studies in patients with heart~     disease. After the better compound is chosen, additional measures of its imaging properties,~     metabolism and pharmacokinetics will be done in subjects with heart failure.~   "
29610|NCT02669550|"~     The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the~     management of difficult tracheal intubation, and it is considered as a gold standard. The~     disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical~     practice recently.This study compares FOB and DE for awake orotracheal intubation in obese~     patients with anticipated difficult airway.~   "
29611|NCT02669537|"~     Utilization of the GoPro camera to facilitate vaginal surgical education among residents and~     medical students~   "
29612|NCT02669524|"~     In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to~     the relative insulin deficiency that characterizes these patients. This defect is believed~     to be due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless,~     the impact of the defect on glucose tolerance is not fully understood. The so-called~     gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which~     includes the incretin effect, but also other factors affecting glucose disposal (e.g.~     glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma~     glucagon levels in the fasting state, and glucagon concentrations fail to decrease~     appropriately and may even increase in response to ingestion of glucose and show exaggerated~     increases after a mixed meal. With the current project the investigators wish to elucidate~     how this paradoxical glucagon response observed in patients with type 2 diabetes affects the~     GIGD, the incretin effect and postprandial glucose excursions.~      Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled~     in this randomised, placebo-controlled, double-blinded study. The aim is to examine the~     effect of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal~     (GIGD), incretin effect and postprandial glucose excursions in patients with type 2 diabetes~     and healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two~     isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.~   "
29613|NCT02669511|"~     An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy,~     safety and pharmacokinetics of PQR309 in patients with relapsed or refractory PCNSL.~   "
29614|NCT02669498|"~     Two recently published articles need to be cited to explain the rationale for our study~     since both studies conclude with contrary findings: The first one is The post-reproductive~     Fallopian tube: better removed? and the other is termed Factors associated with age of~     onset and type of menopause in a cohort of UK women.~      In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every~     hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed~     that pelvic surgical procedures and even simple tubal sterilization are associated with an~     earlier menopause. Hence, this is an important issue as early menopause leads to adverse~     health status.~   "
29615|NCT02669485|"~     The aim of this study was to evaluate the impact of fluorescence imaging on the location of~     colorectal transection lines based on evaluation of perfusion with indocyanine green, how~     it's going to affect surgical planning and its possible benefits in reducing anastomotic~     leakage.~   "
29619|NCT02669433|"~     This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients~     with dementia with Lewy bodies.~   "
29621|NCT02669407|"~     Patients admitted for acute heart failure and undergoing right heart catheterization will be~     enrolled in this study. Subjects will undergo catheterization of the heart to obtain central~     cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will~     undergo a regional nerve block of the splanchnic nerves. Patients will remain in the~     catheterization lab for the duration of anesthetic block and will be continuously~     hemodynamically monitored.~      This study will be a prospective, uncontrolled clinical trial. The study will not be~     controlled as invasive monitoring of hemodynamics will be performed, allowing clear~     demonstration of a cause-effect relationship. The goal of the study is to provide proof of~     concept.~   "
29622|NCT02669394|"~     The investigators will conduct a proof-of-concept randomized controlled trial study to~     provide preliminary evidence of efficacy of a resistance exercise training program for~     maintaining white matter integrity and improving cognitive function in older adults with~     vascular cognitive impairment, compared with a stretch and relaxation program.~   "
29623|NCT02669381|"~     Phenylalanine is an essential amino acid that people need to obtain in their diets. Amino~     acids are the building blocks for protein, which is required to form tissues in the body. It~     is well known that pregnant women require more protein in their diets, but the exact amount~     for each amino acid is undetermined. To find out how much of phenylalanine pregnant women~     require, the investigators plan to study pregnant women in early and late gestation with a~     modern minimally invasive technique.~   "
29624|NCT02669368|"~     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose~     rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic~     cholecystectomy.~   "
29625|NCT02669355|"~     Doctor's attire acts as an important criteria in setting up good relationship between~     patient and physician. Recent evidence as well as strong viewpoints have highlighted the~     possible harm of wearing a white coat. In order to get the patient's perspective on the~     same, this observational study is being conducted to determine the effect of wearing a white~     coat on patient satisfaction in an Indian setting , in patients who visit rheumatology~     outpatient department,in Columbia Asia Hospitals,Bangalore,India.~   "
29626|NCT02669342|"~     The aim of this study is to determine if the Sharklet catheter, with its unique coating,~     reduces infections in participants, when compared to a standard catheter.~   "
29627|NCT02669329|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized~     surface applicator for non-invasive subcutaneous fat reduction in the upper arm.~   "
29628|NCT02669316|"~     NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An~     association of NAFLD with coronary artery disease and with impaired heart function was~     reported, but without considering severity of NAFLD and with the bias of including diabetes.~     Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score~     (BLS) can predict the impairment of systolic heart function, assessed by echocardiography~     (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass,~     Left atrial diameter.~   "
29629|NCT02669303|"~     The purpose of this study is to determine whether injection of platelet-rich plasma derived~     from patient's blood is effective in treatment of shoulder subacromial impingement syndrome~     as compared to the current protocol of methylprednisolone injection.~   "
29630|NCT02669290|"~     The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided~     lead placement improves clinical outcomes for patients needing cardiac resynchronization~     therapy (CRT) compared to traditional posterolateral left ventricular lead placement.~   "
29631|NCT02669277|"~     To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed~     by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.~      The platelet response rate is defined as the percentage of subjects responding to treatment~     with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 100 x 10^9/L and absence of~     bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase~     the base line count with absence of bleeding (partial response), within the specified time~     frame.~   "
29632|NCT02669264|"~     This study evaluates ADCT-402 in patients with relapsed or refractory B-cell lineage acute~     lymphoblastic leukemia (B-ALL). Patients will participate in a dose-escalation phase (Part~     1) and dose expansion (Part 2). In Part 2, patients will receive the dose level identified~     in Part 1.~   "
29633|NCT02669251|"~     Background:~      Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after~     hematopoietic stem cell transplant. It usually affects people with chronic graft versus host~     disease (cGVHD). This occurs when donor stem cells attack the cells of the person who~     received them. BOS reduces airflow and oxygen levels in the body. It may be caused by~     neutrophil elastase in the body. Researchers believe the new drug AZD9668 may help.~      Objectives:~      To test the safety of AZD9668 and see what dose best inhibits neutrophil elastase in people~     with BOS after a stem cell transplant. To study how well the best dose improves lung~     function in those people.~      Eligibility:~      Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and~     BOS.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will have lung function and heart function tests. They will have computed~     tomography scans of the chest.~      Study part 1: Participants will take the starting dose of the study drug by mouth twice a~     day for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles.~      Study part 2: Participants will take the study drug twice a day by mouth at the dose set in~     part 1, for up to 12 months.~      Participants will keep medicine diaries.~      Participants will have several study visits. These may include:~      Repeats of the screening tests.~      Bronchoscopy with bronchoalveolar lavage.~      Sputum samples taken.~      6-minute walking test.~      cGVHD assessment and answer questions.~      Participants will be contacted after the study for up to 24 months.~   "
29642|NCT02669134|"~     The main objective of the CRICKET study is demonstrate that AV and VV optimization using~     SonR improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS)~     after 6 months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial~     design, randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients~     will be randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV)~     optimization or 'fixed settings'. The primary endpoint is an absolute reduction in left~     ventricular end-systolic volume.~   "
29634|NCT02669238|"~     Endometriosis is a chronic relapsing disease characterized by the presence and proliferation~     of endometrial glands and stroma outside the uterus. This is a serious disease, widespread,~     difficult to live with for the patients, but also difficult to treat for practitioners who~     take care of these patients. It affects 1.6% of the general population, but its incidence is~     10 times higher (up 40%) in patients with infertility. It occurs mainly by complex chronic~     pelvic pain and a negative influence on fertility.~      It is a disease whose complexity can be explained to four levels. Firstly, through its~     extremely polymorphic character with intraperitoneal superficial forms, ovarian forms and~     deep sub-peritoneal forms.~      Secondly by the plurality of the main symptoms which are individually non-specific and the~     frequency and / or intensity is not correlated with the severity of the disease. This~     non-specificity of symptoms partially explains the long lead misdiagnosis, which vary by 5~     to 11 years.~      Thirdly, by its prevalence which seems very high and largely underestimated. If its precise~     estimate in the general population is so complicated, it seems very high in many studies of~     patients supported surgically for gynecological reasons. These very large prevalence figures~     are observed when some consultations support the hypothesis of a widespread and probably~     insufficiently evaluated disease.~      Lately by its management, insufficiently amended, for which there is currently only a few~     scientifically supported recommendations.~      Chronic pain caused by the disease associated with altered sexuality to a loss of fertility~     significantly impacts the quality of life of patients.~   "
29635|NCT02669225|"~     Background:~      Brain activity creates waste products. The body s glymphatic system removes this waste,~     especially during sleep. One brain waste product is amyloid-beta (Ab). It plays a role in~     Alzheimer s disease. Researchers want to study the effect of sleep on Ab in the brain.~      Objective:~      To see if sleep affects the amount of waste product removed from the brain.~      Eligibility:~      Healthy people at least 18 years of age.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will answer questions about drug use, psychiatric history, and family history of~     alcoholism or drug use. Participants will complete an MRI screening questionnaire.~      Participants will stay in the clinic overnight two times. On one night they will sleep~     through the night. On the other night they will be kept awake all night. These overnight~     visits can happen in any order.~      Participants will wear 2 activity monitors, on the wrist and the ankle.~      Participants will have positron emission tomography (PET) scans. A small amount of a~     radioactive chemical will be injected through an intravenous (IV) catheter. Participants~     will lie on a bed that slides into the scanner. A cap or a special mask may be placed on the~     participant s head.~      Participants will have magnetic resonance imaging (MRI) scans. The MRI scanner is a metal~     cylinder in a strong magnetic field. Participants will lie on a table that slides into the~     cylinder. A device called a coil will be placed over the head. Participants will do a task~     on a computer screen in the scanner.~      Participants will have tests of thinking, memory, and attention. They may be interviewed,~     complete questionnaires, take pen-and-paper or computer tests, and perform simple actions.~   "
29636|NCT02669212|"~     Background:~      Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to~     long-lasting and disabling fatigue or malaise, inability to recover after exercise, and~     physical and emotional discomfort that may occur after a person has an infection.~     Researchers want to learn more about its causes.~      Objective:~      To learn more about PI-ME/CFS.~      Eligibility:~      Adults ages 18-60 years who have finished at least 7th grade education and either:~      have ME/CFS that started after an infection~      OR had Lyme disease, were treated, and returned to normal health~      OR are healthy volunteers~      Design:~      Participants will initially have a 2-5 day inpatient visit at the National Institutes of~     Health Clinical Center in Bethesda. During the visit, participants will have:~      Medical history~      Physical exam~      Intravenous (IV) line. A thin plastic tube is inserted into a vein.~      Blood and urine collected~      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of~     their brain. They may get a dye through their IV.~      Grip strength tested~      Saliva, cheek swab, and stool collected~      Tilt table test with measures of body functions such as sweating and breathing, blood~     pressure, and heart rate and blood and urine sample collection~      Collection of blood cells. Participants can choose to have the blood drawn through the IV or~     through a machine that filters blood cells and returns the liquid blood back into the~     participant s vein.~      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.~      Heart monitoring~      Sleep study for participants with PI ME/CFS~      Questions about the participant s life and how they are feeling~      Questions from a neuropsychologist~      Questions from an occupational therapist for participants with PI ME/CFS~      Questinos from a nutritionist~      After the initial visit participants will return home. Participants evaluated for PI-ME/CFS~     during the first visit will have their information reviewed by an adjudication panel of~     experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate~     in the second study visit.~      Eligible participants will be invited back for a second study visit. If a participant was~     taking certain medications during the first visit, they may be asked to taper off of them~     prior to the second visit and report any problems. They will also receive an activity~     monitor, fatigue diary, and nutrition log to use for at least one week prior to their second~     visit.~      Participants who are eligible will return for a 5-10 day inpatient hospital visit at the~     National Institutes of Health Clinical Center. During the visit, participants will undergo~     measurements before and up to 96 hours after performing a stationary bike exercise test. The~     purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests~     will be performed before and after exercise testing. These include:~      Sleeping in a room that measures how the body uses energy with EEG monitoring~      Eating a controlled diet~      Performing vigorous exercise for 10-15 minutes~      Questions about how participants are feeling~      Questions about what participants usually eat~      Samples of saliva, blood, urine and stool~      Wearing an activity monitor~      Having an Xray that measures body composition~      Thinking and memory tests~      Heart monitoring~      Transcranial magnetic stimulation. A brief electrical current to the scalp creates a~     magnetic pulse that affects brain activity.~      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of~     their brain. They will do thinking and exercise tasks during the MRI.~      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.~   "
29637|NCT02669199|"~     The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs)~     UC between source sample sweat gland cells wound transplanted effectiveness and safety for~     the treatment of large area skin lesions of the subjects~   "
29638|NCT02669186|"~     The proposed study is a pilot prospective, single-blinded, randomized controlled trial~     evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural~     killer cell population size and cytotoxicity in patients undergoing exploratory abdominal~     laparotomies.~   "
29639|NCT02669173|"~     This study involves participants with recurrent glioblastoma brain tumors (GBM). This means~     that a participant's brain tumor has either returned after being treated by a previous~     therapy, or has continued to progress despite being treated.~      The purpose of this study is to provide proof of concept that suppression of MDSCs~     (myeloid-derived suppressor cells) is feasible in patients with GBM. Rather than targeting~     tumor cells or immune checkpoints, which has been the focus of recent therapeutic efforts,~     direct targeting of MDSCs with low dose capecitabine has the potential to reverse the~     immunosuppressed microenvironment of GBM and thereby reduce tumors~   "
29640|NCT02669160|"~     Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance,~     gait and movement disruptions. These disorders are related to lesions of the central nervous~     system (CNS) that occurs at birth or during the early childhood. The therapeutic management~     of CP is essentially based on reeducation, but may also require specific medical treatments,~     orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed~     in specialized institutions with a significant socioeconomic impact. CP children suffer from~     various sensorimotor impairments, which may evolve into orthopedic deformations, justifying~     the implementation of restrictive devices. The French High Authority of Health (HAS)~     estimates that 50 % of CP children have pains when using contention or verticalization~     devices. These pains are mainly nociceptive and are caused by the passive constraint applied~     on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients~     have led to controversial results regarding the duration of the effect of this therapeutic~     approach. However, the improvement is more important when neuromuscular facilitation~     techniques are added to the reeducation program. Human neuronal adaptation and plasticity~     mechanisms are now understood, with the possibility of a potential partial recovery.~     Non-invasive stimulation methods and neurorehabilitation techniques could participate in the~     CNS re-calibration. Automated assisted movements have already been used and these processes~     showed an increase joint range of motion, bone density and decreased spasticity.~      In recent years, exoskeleton devices have been used on subjects with spinal cord injuries~     allowing motor performances improvement.~      This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing~     walking pattern compared with conventional passive standing-up devices. For this clinical~     trial, the investigators compare the behavior of CP children using a motorized orthosis~     reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in~     their usual conventional passive device. The investigators hypothesis is that the Innowalk~     improves joints range of motion, enhances selective motor control, decreases the medium-term~     spasticity and offers at least the same tolerance as conventional passive devices.~   "
29641|NCT02669147|"~     This is a prospective observational study to evaluate effectiveness and safety of~     Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to~     administer Enzalutamide after anti-androgen therapy.~      CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and~     decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and~     observed the practical treatment. Total research term is for 4 years, consists of 2-year~     case registration terms and 2-year observational terms.~   "
29643|NCT02669121|"~     The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4~     Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE)~     due to genotype-specific (GI.1 and GII.4) NoV strains.~   "
29644|NCT02669108|"~     The primary objective of this study is to explore feasibility of testis functionality~     assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic~     Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the~     three-dimensional structure of normal testis, the levels of specific elements and compounds~     in the tissues (which can only be found via these imaging techniques), and the~     directionality (and alterations in directionality) of tissue structure. Investigators hope~     to develop hypothesis that will in turn suggest bio-markers to be explored in subsequent~     clinical trials.~   "
29645|NCT02669095|"~     This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design,~     double-masked clinical trial using an investigational contact lens and a marketed contact~     lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear~     modality.~   "
29646|NCT02669082|"~     This study will explore the effect of ramelteon 8 mg once daily for 8 weeks for the~     treatment of insomnia patients with depression by using actigraphy.~   "
29647|NCT02669056|"~     Although significant advances in neonatal care have increased survival rates of preterm~     infants born before 28 weeks gestation, a concomitant decrease in neuro developmental~     disorders has not been achieved. Cerebral injuries, well documented during the previous~     years, in preterm babies are particularly deleterious since they occur in a developing~     brain. They affect both white and grey matter by complex mechanisms and the principal~     targets are the developing oligodendrocytes and neurons of the subplate. All these criteria~     define the encephalopathy of prematurity. Nevertheless, the consequences of prematurity at~     the level of the brainstem are not very well known and may explain neuro-developmental~     disorders with normal MRI.~      The assessment of the motor repertoire is complementary to the neurological examination and~     may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed~     acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in~     the development due to the feedback that they send to cortical neurons and reflect the~     maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by~     prematurity may induce alterations of the motor repertoire.~      Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently~     in very preterm babies reflect brainstem abnormalities. These symptoms are also described in~     other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these~     pathologies deficits of the 5-HT system have been described and associated with~     dysautonomia. It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in~     very preterm babies.~      The serotonergic system develops very early during gestation and is one of the first~     neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within~     the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the~     respiratory network. Moreover, previous studies have shown that 5-HT projections to the~     spinal cord are involved in posture and in the coordination. It is tempting to think that~     5-HT deficits may have some repercussions on the development of the CNS, changing activity~     dependent processes, such as spontaneous activity recorded at the spinal level in rodents.~      In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be~     compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior~     fossa, GMs and dysautonomia different parameters such as heart rate variability,~     suction-swallowing and different breathing techniques will be established~   "
29648|NCT02669043|"~     Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with~     anxious depression do not respond as well to currently available antidepressant medications.~     Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of~     depression within hours in many patients with treatment-resistant depression, has been~     associated with superior efficacy in those individuals with anxious compared with~     non-anxious depression. In order to understand this unique effect more fully, the current~     protocol is aimed at further delineating biomarkers of ketamine's effects among individuals~     with treatment-resistant anxious depression compared to those with nonanxious depression.~   "
29649|NCT02669030|"~     Depression with ongoing insomnia is a common clinical presentation with patients. Clinical~     data suggests that patients with insomnia that receive concomitant treatment with a sleep~     aid experience a more robust antidepressant response along with a quicker response. The~     purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia~     medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to~     that of placebo plus antidepressant treatment in patients with depression and residual or~     ongoing insomnia.~   "
29650|NCT02669017|"~     This study evaluates ADCT-402 in patients with Relapsed or Refractory B-cell Lineage Non~     Hodgkin Lymphoma (B-NHL). Patients will participate in a dose-escalation phase (Part 1) and~     dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part~     1.~   "
29651|NCT02669004|"~     Patient-controlled Intermittent epidural bolus versus epidural infusion for posterior spinal~     fusion after adolescent idiopathic scoliosis.~      Scoliosis surgery is commonly performed in adolescent due to idiopathic scoliosis. It is~     reported that the postoperative pain after scoliosis surgery that occurs due to Surgical~     trauma and severe reflex muscle spasm be severe and excruciating. There are many methods for~     postoperative pain management. It is used often opioid , paracetamol and non-steroidal~     anti-inflammatory drug with patient- controlled intravenous analgesia (IV-PCA). In addition;~     intrathecal opioids, one catheter epidural with intermittent dosing bolus of morphine or~     continuous infusion (either opioids or local anaesthetics or both), double epidural catheter~     with continuous infusion and intravenous ketamine infusion were preferred other~     postoperative pain management models.~      Epidural analgesia is accepted procedure with the efficacy and safety profile for~     postoperative pain management in major orthopedic surgery including scoliosis surgery.~     Epidural analgesia techniques commonly have been used in continuous infusion of local~     anesthetics with or without opioid. It was emphasized that there was not adequate data in~     the literature to provide argument concerning the use of epidural opioids after spinal~     surgery. The objective of this study was to compare the effects and side effects patient-~     controlled intermittent bolus epidural analgesia (PCIEA) and patient- controlled continuous~     epidural analgesia (PCCEA) with morphine for postoperative pain control in adolescent~     idiopathic scoliosis after posterior spinal fusion.~      Methods The study was conducted after obtaining written consent from all patients and~     guardian, approval from the Inonu University Faculty of Medicine Ethics Committee. This~     prospective randomized controlled double-blinded study was conducted 47 patient between 8-18~     years, American Society of Anesthesia Classification (ASA) I-II, with idiopathic scoliosis,~     scheduled for elective posterior spinal fusion.~      Patients with a history of allergy to the drugs used in the study protocol, drug abused ,~     preoperative neurologic deficit, inability to use a visual analogue scale, pulmonary,~     cardiac and neuropsychiatric disorders were excluded. Exclusion criteria during the study~     were accidental perforation of dura, faulty epidural catheter placement, postoperative~     neurologic deficit or uncontrollable nausea, vomiting and pruritus.~      The patients who were not premedicated were instructed on the visual analog scale (VAS) and~     the patient-controlled analgesia (PCA) device that was implanted during the postoperative~     period.~      Patients were divided into two groups using the envelope drawing method. Patients who~     received epidural morphine with PCIEA represented Group 1, epidural morphine with PCCEA~     represented Group 2. The anesthetist who collected data and the patients were blinded.~      All operations were performed by the same surgical team. The posterior instrumentation with~     pedicle screws was applied to thoracic and lumbar spine. Epidural catheter was inserted by~     surgeon under direct visualization at the midpoint of the incision and advanced 5-6 cm~     cephalad to thoracic 4-5 before surgical closure. Intubated patients was taken to in the~     reanimation intensive care unit after operation, IV acetaminophen 15 mg / kg was started~     before extubation and repeated every 6 hours.~      After extubation and a neurological examination, patients in the PCİEA group received~     morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion. In Group 2, PCECA~     infusion the following initial setting loading morphine 0.02mg/kg in 8mL, was maintained~     0.01 mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval.~     4 hour limit was 4 mg/kg.~      Pain score, morphine usage, postoperative nausea and vomiting, pruritus, rate their~     satisfaction ,sedation scores and motor block were assessed by researchers who were blinded~     to the study groups at postoperatively 2., 4., 6., 8., 12., 18., ve 24.hour, in all~     patients.~   "
29652|NCT02668991|"~     The purpose of this study is to evaluate the utility of and to clinically validate the~     Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder~     (ASD) compared with other gold standard measures.~   "
29653|NCT02668978|"~     The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in~     reducing the incidence and duration of air leaks after lung resection compared to standard~     techniques.~      Hypothesis: The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in~     lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the~     incidence and duration of prolonged air leaks as compared to standard surgical measures.~   "
29654|NCT02668965|"~     The purpose of this study is to determine whether intrauterine hCG can improve the~     implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.~   "
29655|NCT02668952|"~     Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models,~     excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid~     has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold~     under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI~     outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The~     investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients~     (up to 40 enrolled) into 2 study arms and compare renal outcomes.~   "
29656|NCT02668926|"~     The study will compare the acute emotional and endocrine effects of equivalent doses of~     lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and~     effects of the amphetamines on aspects of social cognition are investigated.~   "
29657|NCT02668913|"~     This is a pilot feasibility study assessing the use of a commercial molecular profiling~     service in the UK's National Health Service (NHS). The impact of knowledge of a patient's~     molecular profile, and the time it takes to generate this knowledge, will be assessed by~     analysis of changes in physicians' treatment decisions prior to and following generation of~     a patient's molecular profile. Implications for benefit with therapies recommended by the~     profile will also be assessed and the following treatment outcomes collected: best response~     (based on routine clinical, radiological and biochemical assessment), progression free~     survival ratio (post Caris Molecular profiling versus prior treatment) and overall survival.~   "
29658|NCT02668900|"~     The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat~     dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD~     can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD~     therapy has risks and benefits that should be weighed from each patient's perspective. An~     ICD battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At~     present, the majority of these batteries are automatically changed without eliciting~     patients' preferences. There is a need for a better way to engage with patients. Patients~     want to be involved in their healthcare decisions, yet more than half of patients with an~     ICD do not know that ICD replacement is optional. To ensure that patients are receiving~     treatment that they value and want, members of the interprofessional team should ensure that~     treatment decisions align with patients' expectations, values and preferences. This rests on~     the principle of shared decision making in which members of the healthcare team and patients~     deliberate together to arrive at a decision which best reflects the preferences and values~     of the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can~     be used. As a result, the investigators developed PDA for ICD replacement. The purpose of~     this feasibility trial is to collect preliminary data to test the feasibility of conducting~     a larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and~     consented participants facing ICD replacement will be randomized to receive the decision aid~     or to usual care. The investigators will assess if this decision aid can improve~     participants' knowledge on ICD therapy and the replacement surgery, increase patients'~     perceived involvement in the decision, and determine whether their actual choice reflects~     their personal values.~   "
29659|NCT02668887|"~     Within the first year after diagnosis, data on employment and quality of life will be~     collected and evaluated in patients with malignant melanoma~   "
29660|NCT02668874|"~     The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention~     rates of sealants placed under Isolite vs. cotton roll isolation. This study will also~     compare the patient and operator acceptability and satisfaction of the two isolation~     techniques as well as the time consumed for sealant application during the two isolation~     techniques.~   "
29661|NCT02668861|"~     The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound~     Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D~     Levels After Endonasal Endoscopic Sinus Surgery~   "
29662|NCT02668848|"~     The investigators previously found that a blood urea nitrogen/creatinine (BUN/Cr) ratio >15~     is an independent predictor of early deterioration after acute ischemic stroke. Another~     study was conducted to determine whether urine specific gravity, another indicator of~     hydration status and one more easily obtained, is also an independent predictor of early~     deterioration or stroke-in-evolution (SIE) in such patients. The investigators also~     conducted a preliminary study, enrolling ischemic stroke patients with a BUN/Cr ratio >15~     and find daily Bun/Cr based hydration help to decrease post stroke infection rate and~     improve 3 months functional outcome. In this study, daily urine specific gravity will be~     used to adjust hydration therapy in ischemic stroke patients with initial Bun/Cr ratio <15.~     The primary outcome is the post stroke infection rate in the first 7 days after admission,~     and secondary outcome is 3 months functional outcome using mRS.~   "
29663|NCT02668835|"~     The proposed study will capitalize on the early predictive information stored in an~     individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features~     of tremors that can be extracted from movement data gathered by modern compact~     accelerometers in order to determine if accurate discrimination of essential tremor (ET)~     from PD can be achieved. Both of these technologies have a proven but somewhat limited~     ability to inform diagnosis of PD or differentiation of PD from ET - especially at early~     stages of the disease. The investigators hypothesize that a combination of prior genetic~     risk and current disease symptomology can synergize for accurate and early discrimination of~     PD from ET and ultimately inform a cost effective approach to movement disorder diagnosis.~      In this study, the investigators will collect blood from individuals with confirmed~     late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the~     Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for~     Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the~     genetic risk of individuals for PD via proven genetic risk models. In addition, participants~     will wear a wristwatch-like accelerometer device that will track their movements (tremors)~     at high temporal resolution and transmit movement data via a smartphone. Cognitive~     distraction tasks will be administered via mobile phones while simultaneously collecting~     movement data. Predictive tremor features will be extracted from movement data via signal~     processing approaches - e.g. discrete wavelet transformation. A final predictive model~     combining movement tracking information and genetic information will be designed in attempt~     to distinguish PD from ET individuals.~   "
29664|NCT02668822|"~     The purpose of this study is to evaluate the efficacy of the etonogestrel (ENG) +~     17β-estradiol (E2) vaginal ring compared to placebo vaginal ring in the treatment of~     dysmenorrhea at Treatment Cycle 2. This study will also assess the safety and tolerability~     of the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis: Relative to the~     placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a~     ≥ 3 point reduction in peak pelvic pain score and no increase in the number of rescue pain~     relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.~   "
29665|NCT02668809|"~     The main goals of this pilot study are to develop a nursing home-customized oral hygiene~     protocol, intended to be delivered primarily by dental hygienists and primary care~     providers, and to identify potential obstacles and barriers to overcome in designing a~     subsequent definitive study on the same topic.~   "
29666|NCT02668796|"~     This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the~     Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem®~     (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to~     Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.~   "
29667|NCT02668783|"~     The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal~     ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at~     Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the~     ENG-E2 vaginal rings. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal~     ring results in a greater proportion of participants with a ≥3 point reduction in peak~     pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets~     taken at Treatment Cycle 2 as compared to baseline.~   "
29668|NCT02668770|"~     The goal of this clinical research study is to find the highest tolerable dose of MGN1703~     that can be given in combination with ipilimumab to patients with advanced tumors. The~     safety of this drug combination will also be studied.~   "
29669|NCT02668757|"~     The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30)~     are given the HeartHab application. The HeartHab application is a smarthphone based mobile~     application that serves as a secondary prevention tool, to support cardiac patients after~     their phase II cardiac rehabilitation program. During study period (4-6 weeks),~     participating patients will be asked to use the application. HeartHab includes a module~     devoted to therapy compliance, one to exercise training prescription and one to risk factor~     control. HeartHab aims to motivate the patient to improve his/her self-management skills and~     hence decrease cardiovascular morbidity (and mortality).~      Motivational aspects and usability data will be collected during study period by means of~     app logs and/or questionnaires/interviews.~   "
29670|NCT02668744|"~     The investigators recently completed an NIH R21 grant, which was a randomized controlled~     trial (RCT) to test the effects of a gardening, nutrition, and cooking program in 375~     low-income Hispanic students living in Los Angeles. Preliminary results from this study show~     that intervention compared to the control students have reductions in BMI parameters and~     waist circumference, increases in daily intake of dietary fiber and vegetables, and improved~     lipid profiles. The investigators want to expand and replicate this study by: a) using a~     cluster randomized school design; b) implementing the program during school hours; c)~     increasing sample size; d) lengthening the intervention period to one school year; e)~     collecting comprehensive metabolic measurements on the child; f) enhancing family workshops;~     g) collecting more parental data; and h) developing and evaluating sustainability~     strategies. Thus, the overall goal of this project is to test the effects of a large~     school-based gardening, nutrition, and cooking RCT (called Sprouts) on dietary intake,~     dietary-related behaviors, obesity, and related metabolic disorders in low-income Hispanic~     youth and their families in Central Texas. Sixteen elementary schools will be randomized to~     either: 1) Sprouts intervention or 2) Control (delayed intervention). At each intervention~     school, the investigators will build edible gardens; form and train Garden Leadership~     Coalitions (GLCs); teach 20 Sprouts in-school lessons to the students; and teach nine~     family-based Sprouts lessons throughout school year. The following measures will be obtained~     for students at baseline and post-intervention: height, weight, BMI, waist circumference,~     body composition (via bioimpedance), blood pressure, glucose, insulin, and lipids (via~     voluntary fasting blood draws), dietary intake, and related psychosocial behaviors (e.g.,~     preference/motivation/self-efficacy to eat FV). The investigators will also measure~     anthropometrics, dietary intake, and related dietary psychosocial variables on the parents~     at baseline and post-intervention. After the intervention year, the investigators will~     provide a series of training workshops and resources to the GLCs and schoolteachers to~     sustain the Sprouts program in subsequent years. The investigators will measure the~     sustainability employed by each school by process logs/surveys, structured interviews, and~     school observations.~   "
29671|NCT02668718|"~     The purpose of this study is to determine whether adjuvant radiotherapy following radical~     prostatectomy in prostate cancer patients with positive margins or capsular penetration~     improves biochemical, overall and/or cancer specific survival and whether adjuvant~     radiotherapy is reasonably well tolerated when compared to watchful waiting.~   "
29672|NCT02668705|"~     Both the main and sub-studies will investigate how consent forms and other health care~     documents are explained to patients. The findings will be used to create a computer program~     that can successfully explain consent and other health-related forms to individuals who have~     difficulty reading and understanding consent forms on their own as a supplement to the~     normal consent process done in research settings.~   "
29673|NCT02668692|"~     To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment~     of psoriasis in Japanese subjects.~   "
29674|NCT02668679|"~     Background: Performance of endoscopy in children requires more patience, experience, and~     expertise than in adults. The anxiety of the children is related to parent's separation,~     loss of self-control, unknown surroundings and strange people that are taking care of them,~     and frequently unpleasant or even painful procedures. Painful and frightening procedures in~     children have been shown to result in short-term physiologic changes and long-term~     behavioral changes. The response to unpleasant stimuli with stress and fear may be~     exaggerated in children and experienced as pain. Most infants and children and many~     teenagers need deep sedation or light general anesthesia to complete a successful and safe~     procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to~     reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions.~      However, this evidence is based mainly on self reports rather than objective measurements.~     Therefore, objective and non-invasive measurements to be utilized in the current study,~     should provide an assessment tools regardless the children's age.~      Multiple studies, beginning in the 1970's, have shown that humor has many positive effects~     on physical and mental health and well-being. Previous investigations have reported that~     humor has beneficial effects on the immune system, stress related to potentially fatal~     illnesses, pain tolerance, and mental functions.~      Dream doctors (DDs) are professional medical clowns or stage artists, who received training~     specifically to understand medical patient's need and to give the patient adjuvant therapy~     during hospital admissions or ambulatory treatment.The Israel dream doctors project,~     integrates professional medical clowning into the medical services provided at Israeli~     hospitals.Studies already proved that presence of medical clowns significantly reduces the~     level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs~     lessen the level of anxiety and attention impairment in children undergoing gastroscopies.~     2) DDs improve the satisfaction of children and their parents during gastroscopies.~      The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children~     and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects~     of DDs on anxiety and attention of children and their parents, undergoing gastroscopies by~     means of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and~     measuring anxiety-related biologic indices.~   "
29675|NCT02668666|"~     This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib~     in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have~     not received prior systemic anticancer therapies for their advanced/metastatic disease.~   "
29676|NCT02668653|"~     This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of~     this study is to compare the effect of quizartinib versus placebo (administered with~     standard induction and consolidation chemotherapy, then administered as maintenance therapy~     for up to 12 cycles) on event-free survival in subjects with FLT3-ITD positive AML.~   "
29677|NCT02668640|"~     The study is a non-interventional, observational study is to assess the effect of Adalimumab~     on health-related quality of life and work productivity in patients with Rheumatoid~     Arthritis (RA) in China.~   "
29678|NCT02668627|"~     Based on the results of recent randomized controlled trials, current international~     guidelines recommend the initiation of endovascular treatment within 6 hours of symptom~     onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected~     patients beyond 6 hour time window. In particular, treatment response to endovascular~     therapy may be greatly influenced by pretreatment collateral status. The aim of this study~     is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for~     COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment~     in a wide range of patients with acute ischemic stroke .~   "
29722|NCT02668055|"~     Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin~     substitutes the effectiveness of clinical trials for the treatment of difficult to heal~     wounds and security.~   "
29723|NCT02668042|"~     The main purpose of this experiment was to evaluate the activity of tissue engineering skin~     substitutes safety and efficacy studies for the treatment of difficult to heal wounds~   "
32139|NCT02636439|"~     The purpose of this study is to examine the effects of weight loss via hypocaloric diet~     (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet~     (CR), aerobic training (AT)and resistance training (RT).~   "
29679|NCT02668614|"~     Skin cancer represents a large problem in today's healthcare setting. The majority of cancer~     diagnoses are attributed to malignant skin diseases including its major types: basal cell~     carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early~     detection of malignant lesions largely increases chances of successful treatment. The~     current gold standard of diagnosis is histopathological examination of biopsied skin.~     Biopsies are not only invasive and expensive, they have variable positive predictive value,~     meaning they may often be preformed unnecessarily. As such, we have developed a skin~     scanner, which is less bulky and expensive that existing similar technologies, as a tool to~     evaluate skin lesions prior to determining the need for a biopsy. Our objective is to obtain~     information in order to validate this skin scanner in the context of its ability to~     accurately identify basal cell carcinoma skin lesions.~   "
29680|NCT02668601|"~     Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic~     risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to~     GDM will be associated with one or more of three critical factors involved in the~     development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased~     beta cell function in Hispanic children when compared to non-exposed children matched for~     ethnicity, age, gender, and Tanner stage. In a subset of this cohort, we will also examine~     the effects of intrauterine exposure to gestational diabetes on the brain pathways that~     regulate appetite and body weight in children ages 6 to 15 years old.~   "
29681|NCT02668588|"~     This is a multicentre, double blind, randomized placebo controlled trial to assess the~     effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph~     Node Dissection (ALND).~      Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.~   "
29682|NCT02668575|"~     Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor~     quality of life, and additional psychosocial stressors; these burdens are particularly~     heightened in advanced stages of the disease. Although supportive care (aka palliative care)~     has been shown to improve many of these outcomes among patients with illnesses such as~     cancer, no clinical trials to date have tested the impact of supportive care for patients~     with CF. The purpose of this pilot randomized clinical trial study is to evaluate the~     feasibility, acceptability, and perceived effectiveness of an embedded supportive care~     intervention, whereby a supportive care specialist will be integrated within the usual care~     experience of patients with advanced CF. The investigators will enroll 50 patients with~     advanced CF, who will be equally randomized to receive this embedded supportive care~     intervention or usual care. Secondary measures include: patient quality of life, mood,~     coping style, satisfaction with care, and symptom burden. This study will provide~     preliminary data to support the development of a larger, definitive, Phase III randomized~     clinical trial.~   "
29683|NCT02668562|"~     Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac~     events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line~     therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased~     bleeding. This may be of particular concern for patients with ACS who require coronary~     artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before~     proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate~     the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS~     patients initially treated with ticagrelor and to identify potential mechanisms underlying~     benefits or complications of early bypass surgery.~   "
29684|NCT02668549|"~     The purpose of this study is to formulate definitions of doctor/pharmacy shopping and~     evaluate its association with abuse/addiction~   "
29685|NCT02668536|"~     The initial focus of the study will be on safety, sun protection factor (SPF)~     characterization, and substantivity (duration of protection) studies. The primary outcome of~     the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles~     (BNP) formulation in 20-25 healthy volunteers with fair skin.~   "
29686|NCT02668523|"~     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near~     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and~     intermediate vision.~   "
29687|NCT02668510|"~     A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with~     Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with~     Resistant Plantar Fasciitis~   "
29688|NCT02668497|"~     The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected~     via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in~     Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past~     clinical studies will be used in determining injection parameters. The objective is to study~     the composition of PD tremor using kinematic tools which may contribute to the knowledge of~     tremor complexity and contribute information that would benefit the development of injection~     parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting~     all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators~     believe a greater improvement in Quality of Life on more daily tasks can be achieved~     compared to the investigator's earlier study in unilateral injections (REB#101749), which~     already showed significant improvement.~   "
29689|NCT02668484|"~     There are different aortic valve prosthesis used for treatment of aortic valve disease~     through catheter-based procedures. The current study aims to compare two different aortic~     valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.~   "
29690|NCT02668471|"~     The purpose of this study is to compare the efficacy of ultrasound- guided with the~     traditional palpation radial artery cannulation in critically ill children.~   "
29691|NCT02668458|"~     The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the~     intubation procedure with two methods of pre-oxygenation:~        1. NIV (Non Invasive Ventilation)~        2. HFNC (High-flow nasal canula oxygen therapy)~   "
29692|NCT02668445|"~     This is a randomized, counterbalanced crossover design, in which 14 male subjects will~     complete two experimental trials. Each trial will be separated by a minimum of at least 12~     days (range: 12-30 days). The study aims to investigate the effects of low glycogen~     availability on skeletal muscle molecular response after a concurrent exercise day.~   "
29693|NCT02668432|"~     Purpose/Objectives: Severe sepsis and septic shock are a common cause of new onset atrial~     fibrillation (NOAF) in the intensive care unit. Development of NOAF in this setting can~     prolong length of stay and increase mortality. Amiodarone is the most commonly used agent~     used in this setting to control rate and rhythm. However, limited data exist detailing~     appropriate dosing in this setting. The primary objective of this study is to evaluate two~     amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients~     with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the~     mean heart rate every 6 hours after initiation of amiodarone infusion to day 7 or death.~      Research Design/Plan: Consecutive patients admitted to the medical or cardiac intensive care~     unit at University Hospital with NOAF in the setting of severe sepsis or septic shock will~     be screened for study inclusion. Data will be collected and stored using Microsoft Excel or~     Access and analyzed with JMP 12.0 and SPSS.~      Methods: Patients aged 18 years or older who develop new-onset atrial fibrillation in the~     setting of severe sepsis or septic shock and in whom the medical team deems appropriate to~     initiate amiodarone therapy in will be considered for study inclusion. Patients will receive~     intravenous (IV) and oral (PO) amiodarone, as per the standard of care. Patients will be~     randomized to a certain quantitative loading dose strategy; either a full loading dose (≥ 5g~     IV or ≥10g PO +/- 20%) or a partial loading dose (<4g IV or < 8g PO).~      Clinical Relevance: With intensive care unit length of stay (ICU LOS) and mortality being~     twice as high in NOAF with sepsis as compared to septic patients without NOAF, the~     investigators ultimately aim to identify a management strategy that may minimize this~     morbidity and mortality while also minimizing exposure to a drug that may cause serious~     adverse effects.~   "
29694|NCT02668419|"~     The purpose of this study is to determine whether neuromuscular electrical stimulation can~     improve exercise tolerance for patients with heart failure and continuous dobutamine use in~     a hospital.~   "
29695|NCT02668406|"~     Clinical samples (blood and voided urine) from patient recruited at Sihanouk Hospital Centre~     of HOPE (SHCH) and HOPE Community Medical Center (CMC) will be processed (decontamination)~     and shipped to SRI International with the purpose of design and validation (proof of~     concept) and (case/control series) of in-vitro diagnostics for melioidosis.~   "
29696|NCT02668393|"~     Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly~     Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure~     of platinum-based first line chemotherapy.~   "
29697|NCT02668380|"~     This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for~     Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give~     patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and~     efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.~   "
29698|NCT02668367|"~     This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple~     ascending dose (MAD), 7-day treatment period study in healthy subjects.~   "
29699|NCT02668354|"~     The aim of this study is to investigate the spectrum of various types of malignant neoplasms~     of infancy, according to the experience of South Egypt Cancer Institute, which represents~     the largest referral site in Upper Egypt.~   "
29700|NCT02668341|"~     Analysis of barriers in psoriasis care from the patient's and the physician's perspective~     and generation of scientific data on the quality of health care in Sweden, Poland, Spain,~     United Kingdom, and Germany~   "
29701|NCT02668328|"~     The proposed study is an integrative scientific undertaking, reflecting the input of experts~     in the behavioral sciences, mHealth technology, computational biology, endocrinology,~     biochemistry, and nutrition. The project features a unique translational approach,~     connecting behavior and biology in an economical manner that provides mechanistic insights~     into the progression of type 2 diabetes (T2D) and the biologic consequences of behavior~     change. The project may have profound implications for the clinical management of early T2D.~   "
29702|NCT02668315|"~     Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients~     with blood cancers, but only 25% of transplant candidates have a sibling donor. A matched~     unrelated donor can be found for 60% of patients but this number is lower for~     non-Caucasians. Cord blood (CB), another source of stem cells, has major advantages over~     unrelated donors including immediate availability, better permissiveness in immune~     mismatches between donor and transplant recipient, better availability for non-Caucasians,~     and less graft versus host disease, a complication frequently seen after transplant which~     negatively affects quality of life. Unfortunately, the use of CB is still limited in adults~     because of the small number of stem cells. UM171, a molecule with hematopoietic stem cell~     expansion properties, has been shown to increase cord blood stem cells 13 fold. In this~     trial, Investigators will use UM171 treated CB in patients who need a transplant but lack an~     acceptable donor.This protocol seeks to test the safety of CB cells expanded with UM171, and~     to determine the kinetics of engraftment as well as the minimal cord blood unit cell dose~     that when expanded achieves prompt engraftment.~   "
29703|NCT02668302|"~     Randomized, controlled, double-blinded clinical trial with 40 patients randomized in 1:1~     ratio to either treatment (bilateral in-office placement of Propel following ESS) or control~     (post ESS standard of care) group and followed for 6 months~   "
29704|NCT02668289|"~     The purpose of this trial is to determine the correlations between various tissue dimensions~     and the changes that occur following a single-tooth dental extraction in human adults.~      65 adult subjects who are in need of dental extractions will be recruited. Clinical~     measurements will be gathered prior to and immediately following the single tooth~     extraction. There will be a 2-week post-operative visit to assess healing and a 14-week~     follow-up for photographic documentation and clinical measurements of the extraction area.~   "
29705|NCT02668276|"~     This research is being done to better understand how a new lab test called the Oncotype DX~     Prostate Cancer Assay may impact what treatment men decide to get and how they feel and~     think about their choice of treatment. The study will compare men who receive this new lab~     test with men who receive the usual counseling given to men after they get a new diagnosis~     of prostate cancer. Prostate cancer is sometimes slow-growing and sometimes fast-growing.~     Healthcare providers are searching for better ways to predict how each tumor will behave so~     that each man can make a better decision about when to receive treatment. The Oncotype DX~     lab test uses leftover prostate biopsy tissue to generate a Genomic Prostate Score (GPS).~     The GPS is related to the risk of a fast-growing cancer being discovered if surgery is~     performed to remove a man's prostate. The goal of this study is to find out if this test~     helps men when they are deciding how their prostate cancer will be treated. Treatment~     options include surgery to remove the prostate, radiation therapy, or an approach called~     active surveillance in which there is no immediate therapy and the tumor is watched using~     prostate specific antigen (PSA) tests and repeat biopsies.~   "
29706|NCT02668263|"~     Seroma formation is a common complication following breast and axillary surgery for breast~     cancer. The use of drains is commonplace in practice after mastectomy, although there is~     evidence to suggest that they do not affect the incidence of symptomatic seroma formation.~     Methods have been adopted in attempts to decrease seroma formation, to varying results,~     which include the use of deep sutures. The aim of this study is to evaluate the effect of~     drains and quilting sutures on the incidence of seroma formation. Patients undergoing~     mastectomy and axillary surgery for breast cancer will be eligible. Patients will be~     randomized to either receive a drain, no drain or no drain with quilting sutures. The~     primary outcome measure will be the incidence of symptomatic seroma. Secondary outcome~     measures will be postoperative length of stay and postoperative pain scores.~   "
29707|NCT02668250|"~     With the increasing aging population demographics and life expectancies, the number of very~     elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly~     large proportion of the high-risk surgical group.~      Cardiac complications and postoperative pulmonary complications are equally prevalent and~     contribute similarly to morbidity, mortality, and length of hospital stay. Specific~     optimization strategy of general anesthesia has been tested in high-risk patients undergoing~     major surgery to improve outcomes.~      Our hypothesis is that a combined optimization strategy of anesthesia concerning~     hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome~     in elderly undergoing high risk surgery.~   "
29708|NCT02668237|"~     Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple~     severity scores. The etiology is never really identified, and the initial treatment is~     always based on probabilistic antibiotics, in the case of an bacterial infection, and by the~     way, potentially severe.~      Molecular tests (multiplex) allow the simultaneous detection of a huge number of~     pathogenic agents, virus and bacteria, are now available.~      This project is based on a new strategy of diagnostic, using a multiplex PCR with quick~     results, coupled to an antigenic urinary test to allow a complete, quick, etiologic~     diagnostic as soon as children are supported in emergency.~      Children are randomized in two groups during inclusions : quick diagnostic strategy versus~     usual practice. Analyse will be centralized on anti-infectious treatment optimization, with~     the aim to better treat patients, minimize the costs, and decrease selection pressure of~     multi-resistant bacteria.~   "
29709|NCT02668224|"~     It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups~     : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24~     sessions) whereas the control group will not be training. The primary outcome is the maximal~     voluntary strength.~   "
29710|NCT02668211|"~     MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of~     its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows~     precise measurement of micromotion around orthopedic implants and hence, may estimate~     long-term fixation to bone.~   "
29711|NCT02668198|"~     The purpose of this study is to compare the accuracy of using different endoscopic imaging~     technique (white light, white light with near focus, narrow band imaging (NBI), NBI with~     near focus) for detection of residual neoplastic tissue at site of prior EMR~   "
29712|NCT02668185|"~     Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational~     product~   "
29713|NCT02668172|"~     The objective of this study is to assess the efficacy of Pasireotide Long Acting Release~     (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients~     previously controlled with combination treatment of long-acting Somatostatin analogs~     (LA-SSAs) and PEGV.~   "
29714|NCT02668159|"~     The overall goal of this study is to investigate the effects and the mechanisms of action of~     a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic~     risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to~     study the acute physiological effects of fish nutrients and to discover gene/metabolite~     networks that underlie these effects.~   "
29715|NCT02668146|"~     Obtain information on whether the medication Perampanel reduces tremor in people with~     essential tremor and is well-tolerated.~   "
29716|NCT02668133|"~     Background: Community based-intervention trials conducted among infants and young children~     in low- and middle-income countries have found that zinc supplementation of young children~     (in the form of liquid supplements or dispersible tablets) increases linear growth and~     weight gain, and reduces the prevalence of diarrhea and respiratory infections, and lowers~     all-cause mortality. Aside from supplements, additional dietary zinc can also be provided~     through home-fortification of complementary foods with small-quantity lipid-based nutrient~     supplements (SQ-LNS; 20g/d), which are typically formulated as a peanut-based paste enriched~     with a vitamin and mineral complex containing 8 mg elemental zinc (as ZnSO4). However, the~     efficacy of LNS as a delivery vehicle for preventive zinc supplementation remains uncertain.~     Two recent studies, which provided LNS containing 4-10 mg Zn daily for 6-9 months found no~     significant differences in plasma zinc concentrations at the end of the intervention period~     compared to placebo.~      This lack of response may be due to the reduced absorption of zinc when it is part of a~     complex food matrix and provided with cereal-based meals; both SQ-LNS and cereal grains~     contain moderate to high concentrations of phytate, the main dietary factor known to~     substantially reduce zinc absorption. The addition of exogenous phytases is an efficacious~     strategy to reduce the phytate content of foods, and increase the bioavailability of dietary~     zinc; however, the efficacy of this approach has not yet been demonstrated for SQ-LNS.~      Objective: The overall objective of the study is to assess the efficacy of adding exogenous~     phytase to SQ-LNS by investigating intra-individual differences in the fractional absorption~     of zinc (FAZ) among children who receive additional dietary zinc (8 mg/d) from SQ-LNS with~     or without phytase.~      Trial approach: The study will be a double-blind randomized controlled clinical trial,~     designed to permit within-child comparisons of zinc absorption from SQ-LNS, with or without~     exogenous phytase, by using the triple stable-isotope ratio tracer technique. The clinical~     study will enroll 34 children between the ages of 18-23 months. The main outcome of interest~     is the intra-individual difference in the FAZ from porridge-based meals containing SQ-LNS~     with and without phytase. An additional 16 children will be enrolled in a pilot feeding~     study to determine portion sizes of study meals.~      Trial setting: Keneba, The Gambia~      Trial interventions:~      The SQ-LNS (20g) used in this study will be provided by Nutriset, S.A.S. The exogenous~     phytase (DSM phytase Tolerase 20000G) is derived from Aspergillus niger; phytase will be~     added to the SQ-LNS during the production phase, and will be enzymatically active in vivo at~     the time of consumption.~      Feeding Protocol and Study Diet: The study diet for the 2day absorption study will consist~     of the following: 1) Two stable-isotope labeled test meals per day (porridge made from~     locally procured non-fermented cereal, mixed with 10 g of SQ-LNS), with children randomized~     to receive either SQ-LNS with phytase or SQ-LNS without phytase on the first day and the~     alternative product on the second; 2) One additional standardized meal per day (e.g. rice~     with sauce); 3) Low-zinc, low-phytate food (e.g. bananas) and breast milk, consumed ad~     libitum if requested (with the exception of 1 hour before and 2 hours after each test meal).~     Children will be fed by their caregivers under supervision by a study fieldworker. The~     SQ-LNS product (without phytase) will be provided to children twice per day for one day~     prior to the start of the stable isotope absorption studies, in order to habituate children~     to the study diet and location. Children will attend the study clinic daily for four days~     and will be enrolled in the study for a total of ten days.~      Zinc absorption studies: The FAZ of zinc will be measured by a triple-isotope tracer ratio~     technique, using orally administered extrinsic labels (Zn-67 and Zn-70) and intravenous~     Zn-68. Urine samples, collected pre- and post-isotope administration (d 1, 5-9) will be~     analyzed for zinc isotope ratios by ICP-MS. FAZ will be calculated based on the mean~     isotopic ratios obtained from the enriched urine samples, and based on the tracer:tracee~     ratio method. TAZ will be calculated by multiplying FAZ by total zinc intake from the test~     meals.~      Data Collection: The following information will be collected from each subject: brief~     medical history; physical examination; weight and height; daily morbidity and~     pre-intervention blood sampling for hemoglobin, complete blood count and plasma zinc~     concentration, malaria and systemic inflammation (C-reactive protein and α-1-acid~     glycoprotein).~   "
29717|NCT02668120|"~     Background : Chronic histiocytic intervillositis is a rare placental disease linked with~     poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase~     was suspected in patients affected by chronic histiocytic intervillositis. This increase may~     correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in~     this pathology.~      Aim : To confirm the association between high levels of alkaline phosphatase and the~     occurrence of chronic histiocytic intervillositis.~   "
29718|NCT02668107|"~     To compare and analyze the effects on the electromyographic activity of preterm newborns~     placed in the hammock position with the activity of newborns not placed in this position.~   "
29719|NCT02668094|"~     Pain is a common side effect of propofol injection. The purpose of this study was to compare~     the efficacy of pregabalin and lidocaine in reducing propofol injection pain.~   "
29720|NCT02668081|"~     This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon~     dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary~     pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic~     papillary balloon dilation groups.Moreover, the investigators compare the results obtained~     from the traditional bile/blood culture and metagenomics.~   "
29721|NCT02668068|"~     Pneumoconiosis is a kind of lung disease due to inhalation of dust such as silica(common~     named Silicosis), coal and rock dust, characterized by inflammation, coughing, and fibrosis.~     Currently there is no effective drug treatment. The whole-lung lavage(WLL) can effectively~     clear the protein-like substances and inhaled dust deposited in the alveoli and bronchioles,~     as well as the pulmonary alveolar macrophage(PAM) and the resulting induced inflammation,~     fibrosis induced factor, serve to improve respiratory function, relieve symptoms of~     efficacy, but can't slow down or reverse the progression of pulmonary fibrosis.~      By taking large volume whole-lung lavage (WLL) as a conventional therapy, this study intends~     to observe and evaluate the safety and efficiency of combined large volume WLL with~     mesenchymal stem cell (MSC) transplantation for treatment of Pneumoconiosis. Moreover, the~     immune regulation effect between large volume WLL and combined large volume WLL with MSC~     transplantation will also be preliminarily investigated and discussed.~   "
29724|NCT02668029|"~     Patients with pulmonary fibrosis often desaturate on exercise. There are no data showing~     whether ambulatory oxygen can be useful to improve exercise capacity in this condition.~     Ambulatory ambulatory oxygen is often denied to these patients based on studies conducted on~     patients with chronic obstructive pulmonary disease, a completely different condition for~     physiopathology, prognosis, and response to therapy. We therefore planned a controlled study~     to verify the usefulness of ambulatory oxygen in patients with pulmonary fibrosis~   "
29725|NCT02668016|"~     Front-line clinicians cannot currently test for an individual participant whether symptoms~     experienced are the pharmacological result of a statin or due to other phenomena. In this~     trial, participants who have previously ceased statins due to side effects will be offered~     the opportunity to undergo twelve randomly ordered 1-month periods. There will be four~     periods of no medication, four periods of placebo and four periods of statin. The placebo~     and the statin pills will be identical in appearance. Participants will record on a daily~     basis side-effects experienced. At the end of the study, the one-month sessions are sorted~     into the order shown above. The participant can then observe directly how much of the~     increase in symptoms seen with statin is also seen with placebo.~        1. Hypothesis 1: that >30% of participants enrolling for the study will complete it.~        2. Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological~        3. The investigators will define the Nocebo proportion of side effects.~        4. Hypothesis 3: that the majority of participants, at 6 months after completion, will~          either be taking statins or have declined statins for reasons other than perceived side~          effects.~   "
29726|NCT02668003|"~     It is known from many studies that when patients have developed chronic widespread pain~     (CWP) or fibromyalgia that managing such symptoms is extremely challenging for both doctors~     and patients. The investigators have shown in a recently completed study funded by Arthritis~     Research UK that a course of Cognitive Behaviour Therapy delivered by telephone (tCBT) or an~     exercise regime can substantially improve the chances of the symptoms improving. The~     investigators now plan to offer this therapy to patients who are at a high risk of~     developing CWP (but who have not developed it yet) to see whether its onset can be~     prevented.~   "
29727|NCT02667990|"~     22 women Testing orthopedic stilettos compared to standard stilettos and a comfy trainer.~      Testing involves pedobar pressures and a validated comfort questionnaire.~   "
29728|NCT02667977|"~     The study aim is to isolate a single type of patient (pediatric patient with acute~     gastrointestinal symptoms) and evaluate the use of hypotonic (0.45 NS) vs. isotonic (0.9 NS)~     fluids in these patients in regards to changes in their serum sodium and iatrogenic~     hyponatremia.~   "
29729|NCT02667964|"~     FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore,~     both hormones are influenced by physical activity. The following hypothesis will be tested:~     FGF-21 is regulated insulin-dependent during exercise.~   "
29730|NCT02667951|"~     The illness course and symptoms of dementia is usually very long and characterized with~     behavioral, psychological and physical changes. Family caregivers' stresses change during~     the illness trajectory as well. The purpose of this study is to compare the costs and~     effectiveness of two care models- home-based caregiver-training program model and routine~     care model for dementia elders in Taiwan.~   "
29731|NCT02667938|"~     The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in~     patients with Benign Prostatic Hyperplasia and Erectile Dysfunction~   "
29732|NCT02667925|"~     The treatment of advanced ovarian cancer is based on the combination of chemotherapy based~     on platinum salt and surgery whose quality is the major prognostic factor.~      A meta-analysis of retrospective series had shown that for every 10% increase in the~     complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al,~     2001). Currently, it is recognized that the best chance of survival conferred to patients~     whose initial surgical residue is zero (Harter et al, 2009).~      However, even if macroscopically complete surgery and whatever the type of systemic~     chemotherapy, peritoneal recurrence remains high for more than 75%.~      To reducing it of recurrence, a therapeutic approach is to administer chemotherapy~     intraperitoneally.~      The intraperitoneal chemotherapy consists to administer the drug directly into the~     peritoneal cavity.~      Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of~     an intraperitoneal chemotherapy according to this method with a conventional systemic~     chemotherapy. Alberts reported a significant improvement in the median overall survival.~     Armstrong shows in addition a decreased risk of recurrence.~      It must be remembered that:~        -  The establishment of an intra-abdominal catheter does not always ensure complete flow~          of drugs into the peritoneal cavity (major postoperative adhesions).~        -  There may be problems of catheters becoming blocked and requiring local treatment;~          these problems can cause abdominal pain whose care is difficult. Thus almost half of~          patients fail to get all six courses of intraperitoneal chemotherapy.~      Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP~     peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that~     the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy~     within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003,~     Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal~     pain sites described by the patient as well as peritoneal recurrence sites found during~     monitoring.~   "
29733|NCT02667912|"~     Objective of this study is to evaluate whether a distal mode of endovascular renal~     denervation with the treatment performed primarily in segmental branches of renal artery is~     more effective than conventional mode of the intervention with the treatment equally~     distributed within its main trunk for the treatment of drug-resistant hypertension.~   "
29734|NCT02667899|"~     Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS~     (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.~      Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group~     and Control group. Three months after treatments, the result will be analysed and concluded.~   "
29735|NCT02667886|"~     The purpose of the study is to test different doses of X4P-001 given alone and in~     combination with axitinib in patients diagnosed with advanced renal cell carcinoma. The~     goals of the study are to determine the safety and tolerability of X4P-001, as well as the~     potential effect it may have on the body and the cancer tumor.~   "
29736|NCT02667873|"~     Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of~     orally administered SL-801 in patients with Advanced Solid Tumors~   "
29737|NCT02667860|"~     The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as~     superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic~     results, analgesia requirements and length of hospital stay. The objective of this study is~     to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in~     patients undergoing laparoscopic right hemicolectomy.~   "
29738|NCT02667847|"~     Preoperative anxiety is a complex clinical concept with both physiological and psychological~     consequences.~   "
29739|NCT02667834|"~     Social cognition and interaction training (SCIT), a group-based treatment that aims to~     improve both processing social information and functioning, may be an effective treatment~     for enhancing the social skills of people with schizophrenia. This study will compare the~     effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual~     (ETP) in helping people with schizophrenia improve their social cognition and social~     functioning so specially on negative symptoms. Many studies show a connection between~     negative symptom and social cognition in schizophrenia.~   "
29740|NCT02667821|"~     The Investigators are performing a study to determine, in patients with chronic/recurrent~     neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements,~     including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow~     dynamics affecting brain perfusion, and extend the current data set on these variables~   "
29741|NCT02667808|"~     The aim of this study is to identify reproductive health priorities among individuals living~     with HIV.This study also seeks to explore factors that influence fertility, family planning,~     and sexual behavior among individuals with HIV who are receiving antiretroviral therapy~     (ART).~   "
29742|NCT02667795|"~     It is generally accepted that physically fit patients cope much better with the stress of~     surgery and recover faster. Consequently several research studies have tried to increase~     people's level of fitness before they have surgery. These previous research studies have~     usually required patients to carry out intense, structured exercise programmes that involve~     going to a gym. However such programmes are not 'user friendly' especially if people are not~     used to taking a lot of exercise. In this pilot study we want to test the feasibility of a~     home based programme that tries to increase patients' level of fitness by gradually~     increasing the number of steps they walk every day.~      Participants will be randomised into one of two groups. One group of participants will be~     asked to increase their level of activity by gradually walking further (the exercise group)~     and the other group will carry on with their usual level of activity (the usual activity~     group) .~      Assessments People in both groups will have an assessment on 3 occasions: when they join the~     study, just before surgery and 3 months after surgery.~      This assessment involves:~      Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for~     some information about their medical history Completing three questionnaires about how they~     are feeling and their quality of life.~      People who are randomised to the exercise group will be advised about how many steps to take~     based on how they did in the initial walking assessment. The number of days or weeks they~     will be asked to take a daily walk will depend on how much time there is between them~     joining the study and the date of their surgery. We think this will be about 2 weeks.~   "
29743|NCT02667782|"~     The aim of this study is to examine which MBI protocol, MBCT or MBSR, is more suited for use~     among local carers of PWD, as measured by better mental health outcomes in PWD, such as~     reductions in stress and improvements in mental wellbeing.~   "
29744|NCT02667769|"~     This is a prospective study with a crossover design, where fasting with a day of complete~     fasting and a fasting day with the permission intake of calories- and carbohydrate-free~     foods are compared in a randomized order. Underlying hypothesis is that at the same basal~     insulin substitution with the fasting of both protocols , no significant differences in the~     glucose-day or -night profiles revealed. So the same conclusions regarding the consistency~     of basal insulin dosing revealed during the implementation of the part of patients is rated~     as more pleasant when calories and carbohydrates-free food are allowed.~   "
29745|NCT02667756|"~     This observational study seeks to identify and validate novel soluble biomarkers (within~     blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual~     with an acute knee injury, a group of individuals in which ~50% will progress to symptomatic~     radiographic knee osteoarthritis (OA).~      150 individuals will be followed over 5 years with clinical assessment including validated~     questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance~     imaging (MRI)).~   "
29746|NCT02667743|"~     An open-label randomized and controlled clinical trial: This study was to compare the~     anticancer efficacy and safety in the First-Line Treatment in patients with Advanced~     Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with~     Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil)~     In combination with Cisplatin in the way of an open-label, randomized controlled clinical~     trial.~      Treatment Protocol:~      The subjects were randomized in the Paclitaxel Micelles for Injection Group and the~     Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method~     was adopted in this trial. Since the study was a comparison of first-line treatment, the~     test for superiority was adopted. The objective response rate was the primary indicator of~     efficacy in this study.~      Trial Group:~      Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks~     constituted one course of treatment.~      No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required~     for the patients before infusion of Paclitaxel Micelles for Injection patients.~      Control Group:~      Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks~     constituted one course of treatment.~      Standard preventive treatment must be given to patients in accordance with the specific~     requirements in specifications of Paclitaxel Injection.~      Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper~     limit.~      To estimate the sample size based on objective remission indicators (CR + PR) in the study.~     Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined~     with Cisplatin in the Trial Group is different with that of first-line treatment of advanced~     non-small cell lung cancer, and is also different with that of the Cremophor EL-containing~     Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings:~     assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the~     proportion of 2: 1. According to the sample size formula , a total of 426 patients is~     required, including 284 patients assigned in the Trial Group and 142 in the Control Group.~     In consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468~     cases were included in the groups, including 312 in the Trial Group and 156 in the Control~     Group.~   "
29747|NCT02667730|"~     In this 4-arm pragmatic randomized control trial, the investigators hope to decipher whether~     the use of non-opioid analgesics (naproxen, celecoxib, acetaminophen) in addition to~     standardized physiotherapy during the acute phase of grade I-II ankle injuries will result~     in functional differences compared to standardized physiotherapy alone~   "
29748|NCT02667717|"~     AlgoMIR project born thanks to a meeting between pain professionals and re-education staff.~     The goal of this project is to develop and evaluate a program of learning with exercises by~     mirror therapy, that could be easily shared with paramedic teams and easily adapted to~     different handicaps.~      Researchers have chosen to select patients with re-education of the upper extremity to~     benefit from rehabilitation sessions either from physiotherapists present in their city, or~     of functional rehabilitation hospital units.~   "
29749|NCT02667704|"~     The trial was designed to investigate whether, and to which extent, multiple doses of~     bosentan may influence the plasma levels of nintedanib administered as a single dose.~   "
29750|NCT02667691|"~     The objective of this study is to evaluate the influence of a 3 months SODB® supplementation~     in adipose tissue modulations of overweight women, in comparison to a placebo.~   "
29752|NCT02667665|"~     Examine the construct validity, the test-retest reliability, the concurrent validity with~     the standard dementia rating scales and the reactivity of a novel dementia rating scale~     QuQu scale: QUick QUestion scale final for the evaluation of patients with Alzheimer's~     Disease Dementia and Mild Cognitive Impairment.~   "
29753|NCT02667652|"~     The purpose of this study is to investigate the curative effect of the length of the jejunum~     exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and~     reasonable operation parameters.~   "
29754|NCT02667639|"~     The purpose of this fist in human study is to evaluate the safety and tolerability of~     RPH-104 in humans.~   "
29755|NCT02667626|"~     The investigators propose to test the efficacy of the Reproductive Health Survivorship Care~     Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young~     breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy,~     treatments that impair ovarian function and result in significant reproductive health late~     effects. These late effects include symptoms of estrogen deprivation such as hot flashes,~     fertility concerns, limited contraception options and sexual problems. Together they have a~     major, negative impact on quality of life.~      Despite substantial research, treatment guidelines and clinical expertise on these issues,~     most YBCS and their healthcare providers have limited guidance on how best to manage these~     reproductive health late effects. The research team has generated a practical, accessible,~     evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their~     providers to address this deficit in survivorship care. This clinical trial will test if~     YBCS who receive the web-based SCP-R are more likely than controls to improve on at least~     one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and~     contraception.~   "
29756|NCT02667613|"~     Studying in a RCT the changes in everyday llife activities of children with CP during~     HABIT-ILE or control period, changes being scored by parents and by experts.~   "
29757|NCT02667600|"~     The aim of this study is to assess the ability of the Triton Device to measure blood loss~     among women undergoing elective and non-elective cesarean delivery. This patient population~     often experiences significant blood loss during surgery, and measurements of surgical blood~     loss are often inaccurate.~   "
29758|NCT02667587|"~     The main purpose of this study is to compare how long patients with glioblastoma (GBM, a~     malignant brain cancer) live after receiving temozolomide plus radiation therapy compared~     with patients receiving nivolumab in addition to temozolomide plus radiation therapy.~   "
29759|NCT02667574|"~     Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with~     locally advanced BCC.~   "
29760|NCT02667561|"~     This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics~     and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days~   "
29761|NCT02667548|"~     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a~     well-proved measure in CHD management. However, the knowledge about the real-life PCI use~     and how evidence-based therapies in routine clinical practice is limited. By consecutively~     recruiting PCI patients in a large-scale hospital in in Northeast China,this study will~     examine various real-life factors, that may affect patients recovery after the procedure.~     Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be~     established based on the findings, to improve patients outcomes in future finally.~   "
29762|NCT02667535|"~     This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of~     Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy~     volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and~     healthy volunteers will receive 2.0% dose. All treatment will last 7 days.~   "
29763|NCT02667522|"~     The purpose of this study is to test causal links between dimensions of positive and harsh~     parenting and children's brain responses to rewards and errors, using a parenting~     intervention.~   "
29764|NCT02667509|"~     Myopia has emerged as a major health issue in east Asia, because of its increasingly high~     prevalence in the past few decades (now 80-90% in school-leavers), and because of the~     sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of~     those completing secondary schooling in this part of the world. Similar, but less marked,~     changes are occurring in other parts of the world. The higher prevalence of myopia in east~     Asian cities seems to be associated with increasing educational pressures, combined with~     life-style changes, which have reduced the time children spend outside.~   "
29765|NCT02667496|"~     Primary Objective:~      To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC)~     on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to~     Alzheimer's disease (AD).~      Secondary Objective:~        -  To evaluate safety and tolerability of Leukine versus placebo.~        -  To explore the effect of Leukine versus placebo on cognitive performance.~        -  To collect biospecimens for future biomarker research.~   "
29766|NCT02667483|"~     This is a phase I/II study to evaluate the safety, tolerability, efficacy, and~     pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD)~     and to determine the dosage for subsequent studies.~   "
29767|NCT02667470|"~     The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score~     (OABSS) scores between before and after Solifenacin treatment to OAB patients and to~     evaluate correlation between change of OABSS scores and other measures for OAB symptoms.~   "
29768|NCT02667457|"~     The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to~     image atherosclerotic plaque that may rupture and break off artery walls. This is caused by~     apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in~     the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up~     on any artery in the body.~   "
29769|NCT02667444|"~     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel~     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.~   "
29788|NCT02667197|"~     The purpose of this study is to determine reliability of codes and data from electronic~     medical records to predict and measure overdose and death in patients prescribed opioid~     analgesics. The study will compare this electronic data to data manually obtained from~     medical charts.~   "
29770|NCT02667431|"~     Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical~     health and decrease costs for both patients and the health care system. At the time of~     endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a~     gynecologic oncologist, but the majority will undergo surgery within weeks of their~     diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and~     concurrent surgery performed. This would spare the patient two surgeries, decrease the~     emotional distress associated with SUI symptoms, decrease the costs associated with SUI for~     the patient and possibly improve overall quality of life. The proposed study will compare~     the quality of life and clinical outcomes among women with endometrial cancer and SUI that~     have concurrent surgery to women that do not have concurrent surgery. The findings of our~     proposed research will provide valuable information necessary for woman and clinicians to~     make decisions regarding the treatment of SUI, including evidence regarding the risks and~     benefits of performing concurrent endometrial cancer and SUI surgery.~   "
29771|NCT02667418|"~     The purpose of this study is to determine whether fidaxomicin and vancomycin followed by~     taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the~     treatment of recurrent Clostridium difficile infection.~   "
29772|NCT02667405|"~     This study investigates the effect of hot packs versus whirlpool and exercise for patients~     with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two~     groups, with one group receiving hot packs during therapy and the other immersing the arm in~     a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of~     motion and volume of the hand are evaluated, with measurements taking place before and~     immediately after heat during each visit.~   "
29773|NCT02667392|"~     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing~     an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88~     million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability~     contributes to these costs. To walk again is the number one stated goal for Veterans who~     have had a stroke. Teaching patients post-stroke to use their weak leg while they are~     regaining walking function and to not compensate by over-using their strong leg is necessary~     to restore safe, efficient walking ability. This project will determine if providing~     biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage~     use of the weaker leg during walking training, in addition to therapists' feedback, will~     help Veterans regain use of their weak leg, improve their endurance and improve their~     balance when walking in challenging environments.~   "
29774|NCT02667379|"~     Determination of allergenicity of cat dander samples obtained before and after vaccinating~     the cat~   "
29775|NCT02667366|"~     The aim of the study is the examination of effectiveness and cost-effectiveness of a~     telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in~     primary care.~   "
29776|NCT02667353|"~     To study the potential neurorestorative effects of electroconvulsive therapy (ECT) in~     depressed patients by measuring brain derived neurotrophic factor (BDNF) serum levels and~     hippocampal volumes in severely depressed patients receiving ECT.~   "
29777|NCT02667340|"~     To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made~     byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of~     specific soccer skills, and on cognitive function during and following a simulated soccer~     game.~      Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during~     the game with Generation UCAN vs isoenergetic placebo (glucose).~   "
29778|NCT02667327|"~     The purpose of this study is to determine whether Granexin gel is safe and effective in the~     treatment of diabetic foot ulcers.~   "
29779|NCT02667314|"~     Meta-analyses indicate beneficial effects of cognitive training and cognitively challenging~     video games on cognition. However, cognitive effects of solving jigsaw puzzles - a popular,~     visuospatial cognitive leisure activity - have not been investigated, yet. Thus, the primary~     aim of this study is to evaluate the effect of solving jigsaw puzzles on visuospatial~     cognition. As secondary aims, effects on psychological outcomes (self-efficacy, perceived~     stress, well-being) and visuospatial everyday functioning (instrumental activities of daily~     living and self-reported cognitive failures in everyday life) are examined.~   "
29780|NCT02667301|"~     The purpose of the study is to understand the exact mechanism of the activity of paratubal~     muscles in opening eustachian tube in patients with the functional eustachian tube and those~     with the eustachian tube dysfunction problem.~   "
29781|NCT02667288|"~     This is an open-label safety study. During this study, the investigator will identify 4~     eligible SK Target Lesions on each subject on the trunk, extremities and face.~   "
29782|NCT02667275|"~     This is a randomized, double-blind, vehicle-controlled, parallel group study.~   "
29783|NCT02667262|"~     The purpose of this study is to develop and validate a classification model based entirely~     on medical claims data that can be used to identify patients experiencing prescription~     opioid abuse/addiction among patients receiving extended-release (ER) and/or long-acting~     (LA) opioids~   "
29784|NCT02667249|"~     Compliance to the clinical pathway, postoperative complication and total cost of the~     hospitalisation of patients undergoing elective cholecystectomy for symptomatic~     cholecystolithiasis were collected over two different periods: using a clinical pathway in~     form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the~     paper based medical treatment and nursing documentation (group 2, n=123). Outcome measures~     were compliance of the clinical pathway and total costs per case.~   "
29785|NCT02667236|"~     This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101~     Solution 40% compared with Vehicle Solution.~   "
29786|NCT02667223|"~     This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and~     hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single~     subcutaneous injection. Subjects will remain confined at the research clinic for~     approximately 2 days. After discharge, subjects will return to the research clinic 15 times~     during 12 weeks.~   "
29787|NCT02667210|"~     To assess whether the percentage of patients with behaviors suggestive of misuse, diversion,~     abuse and/or addiction described in the medical record increases across pre-defined~     categories of increasing doctor/pharmacy shopping behavior.~   "
29789|NCT02667184|"~     The goal of this study is to determine subjective gastrointestinal tolerance response and~     differences in breath hydrogen response following the consumption of different types of low~     FODMAP oral nutrition supplements. This randomized, crossover study requires participants to~     arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete~     gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen~     analysis at various time points over a 4 hour time period.~   "
29790|NCT02667171|"~     International and national publications emphasize that COPD rehabilitation is a key~     cornerstone in the standard treatment of COPD, based on more than 15 years of research in~     COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression~     and physical function. COPD rehabilitation including special physical training,~     patient-directed education and smoking cessation is core rehabilitation elements, which~     today are recommended as mandatory content in standard COPD rehabilitation.~      Standard COPD rehabilitation is an established offer in all regions and municipalities in~     Denmark. It is however a well-known challenge, that persons with the most severe COPD~     symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent~     exacerbations, socially isolation, transport distance to rehabilitation are main reasons why~     people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why~     there at present are no rehabilitation alternatives for patients with the most severe COPD~     symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals~     in the COPD patients' own home via a computer screen could likely encourage more people to~     participate. The number of RCT's investigating the effect of supervised Online delivered~     COPD rehabilitation in groups versus established COPD rehabilitation are very limited.~      The purpose of this randomized study is to investigate the short-term and long-term efficacy~     of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation~     in people with severe and very severe COPD. The outcome of the intervention is measured on~     walking distance, muscle endurance, activity level, quality of life and COPD symptoms~     respectively. Outcomes are measures before intervention start, end of intervention. This~     study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in~     separate publication.~      Hypothesis~        1. COPD online rehabilitation provides significant larger improvements than the usual care~          on walking distance, muscle endurance, activity level, and quality of life and COPD~          symptoms in people with severe and very severe COPD.~        2. COPD online rehabilitation and conventional COPD rehabilitation, provides clinically~          relevant improvement on walking distance, muscle endurance, activity level, quality of~          life and COPD symptoms in people with severe and very severe COPD.~   "
29791|NCT02667158|"~     To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to~     obtain prescriptions opioids and assess whether the percentage of patients reporting misuse,~     abuse and/or diversion increases across defined categories of doctor/pharmacy shopping as~     defined in Study 4A.~   "
29792|NCT02667145|"~     Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care~     program using assistive technology for treatment of hand osteoarthritis.~   "
29793|NCT02667132|"~     The aim of this study was to retrospectively review the granulomatous mastitis and evaluated~     current approach and treatment.~      HYPOTHESIS Although there is no common protocol for the treatment and management process of~     GM, the ternary treatment (medical treatment following by surgical procedure,~     Steroid+Antibiotic and surgical procedure, respectively) is considered as the most~     successful treatment approach.~   "
29794|NCT02667119|"~     The purpose of the study is to determine the safety and efficacy of an integrated treatment~     for substance abuse and posttraumatic stress disorder for young adults. The integrated~     treatment includes two established psychosocial treatments for substance abuse (Contingency~     Management) and posttraumatic stress disorder (Prolonged Exposure therapy).~   "
29795|NCT02667106|"~     This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following~     acute, topical, intranasal administration to healthy male and female volunteers.~   "
29796|NCT02667093|"~     The purpose of this project is to develop a process to identify highly personalized antigens~     that are uniquely expressed by the patient's own leukemia cells that can be used for~     cellular immune therapy.~   "
29797|NCT02667080|"~     The main purpose of the study is to assess to which degree a series of sperm parameters~     known to be associated with fertilization and implantation potential in artificial~     reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days~     and 2 hours of sexual abstinence in males from couples referring for ART treatment.~   "
29798|NCT02667067|"~     This study is intended to demonstrate that the Simplify® Disc is at least as safe and~     effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat~     one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as~     intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain~     or myelopathy due to a single-level abnormality localized to the level of the disc space in~     subjects who are unresponsive to conservative management.~   "
29799|NCT02667054|"~     To determine if RX0041-002 is a safe and effective topical anesthetic.~   "
29800|NCT02667041|"~     Major depressive disorder (MDD) is a debilitating illness that affects millions of~     individuals in North America and can result in clinical symptoms including loss of pleasure~     and feelings of worthlessness, in addition to significant cognitive impairments (e.g.,~     memory, attention) that affect daily functioning. Major depression bears a heavy burden for~     the individuals and family members afflicted, as well as an enormous health care and~     economic cost. Approximately half of major depressive patients seek out treatment for their~     illness and only 20% of those individuals report their treatment as satisfactory. Many MDD~     patients do not respond to pharmacological therapy following the first course of treatment,~     resulting in the need for alternative measures to alleviate the clinical and cognitive~     symptoms of treatment-resistant depression and the targeting of these therapies to better~     suit each individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a~     well-accepted, non-invasive technique that utilizes currents to induce electrical fields~     that excite specific brain regions. The current recommended practice of rTMS involves the~     administration of a biphasic stimulus waveform; however, a novel method using monophasic~     pulses may prove more effective for the treatment of depression. The present study aims to~     determine the effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in~     MDD patients through electrophysiological recordings of the brain taken before and after 6~     weeks of stimulation. Additionally, the study aims to investigate various biological markers~     linked to clinical rTMS response; these brain markers will help in personalizing treatment~     for individuals suffering from MDD.~   "
29801|NCT02667028|"~     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a~     well-proved measure in CHD management. However, the knowledge about the real-life PCI use~     and how evidence-based therapies in routine clinical practice is limited. In a large-scale~     hospital in Northeast China, the investigators will examine various factors of 3007~     consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical~     records will be reviewed and abstracted to evaluate the clinical treatment pattern and~     outcomes. Basic data and innovative evidence will accelerate evidence-based clinical~     practice, and improve patients' outcomes in future finally.~   "
29802|NCT02667015|"~     The aim of the current study is to develop and pilot test an anxiety sensitivity-based~     intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions~     include determining whether a broadly-applicable AS-based intervention can significantly~     decrease both substance misuse and anxiety. Secondary aims include examining the impact of~     this intervention on general functioning and depressive/anxious symptoms. In phase I, an~     initial pilot was conducted to examine the feasibility, safety, and patient satisfaction~     with the protocol, and to estimate potential efficacy of the protocol. In phase II,~     participants will be randomized to the intervention or a control condition.~   "
29803|NCT02667002|"~     Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to~     random numbers table. In one group, conventional abdominal sacral hysteropexy will be~     perform and another group bilateral abdominal sacral hysteropexy will be perform with~     polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI~     on three plane (axial, sagittal, coronal). Then the results of thus two groups will be~     compare to results of nullipara patients. Investigators will investigate which technique~     keep the vaginal axis is closer to the original anatomic position.~   "
29804|NCT02666989|"~     Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al,~     2010), where three weeks of open label placebo proved superior to a wait-listed control~     group. Another pilot study demonstrated efficacy in treating children suffering from ADHD~     with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that~     placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen~     et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary~     attempt to treat depression with open label placebo proved the feasibility of such a study,~     but was too small and brief for conclusive results (Kelley et al, 2012).~      We provide here the protocol for a study to assess the effect of open label placebo~     treatment for depression.~   "
29805|NCT02666976|"~     Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump~     inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study~     is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the~     focus of symptom score, histopathologic findings and inflammatory biomarker.~      A prospective study performed at single hospital enrolled 20 patients who were diagnosed~     clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal~     impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once~     daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after~     treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary~     elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T~     lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be~     accessed.~   "
29806|NCT02666963|"~     This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901~     following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.~      This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD)~     and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be~     conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of~     up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901~     or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4~     will be assessed in each group prior to dose escalation.~      Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3~     groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio~     to receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and~     available pharmacokinetics through Day 17 will be assessed in each dosing group prior to~     dose escalation.~   "
29807|NCT02666950|"~     This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without~     cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic~     syndrome that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether giving WEE1 inhibitor AZD1775 works better with or without cytarabine in~     treating patients with advanced acute myeloid leukemia or myelodysplastic syndrome.~   "
29808|NCT02666937|"~     A prospective study in the ICU in a university hospital in Amsterdam. The relationship~     between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is~     investigated in the general ICU population in order to investigate which transcutaneous~     saturation values are safe.~   "
29809|NCT02666924|"~     This study aims to determine whether providing language and culturally appropriate cooking~     classes to Chinese Canadian individuals with diabetes will help to improve their diabetes~     control, knowledge and self care activities. The control group will receive current standard~     care of two diabetes education classes led by the dietitian and nurse. The intervention~     group will receive standard care and a series of four interactive cooking classes led by a~     dietitian, nurse and chef. We will compare the results of blood work, knowledge and self~     care questionnaires between the two groups to determine whether there are any benefits to~     attending these cooking classes.~   "
29810|NCT02666911|"~     Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no~     history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with~     the 2D transducer and then with the 4D transducer and compared to images captured with the~     new 4D transducer, using the same movement data analysis protocols. Investigators will also~     assess the inter and intrarater reliability of the 4D transducer images, by using two~     different sonographers, both trained in the technique, measuring the same blinded images on~     separate occasions, at least two weeks apart. The overall goal of this project is to assess~     the reliability, or reproducibility, of measurements in normal subjects using a novel 4D~     ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect~     motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of~     patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome~     (CTS).~   "
29811|NCT02666898|"~     Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine~     months /~      Study Part 1:~      All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days~      Study Part 2:~      After evaluation at D1 of month 9:~      If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of~     420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will~     receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation~     of M16~   "
29812|NCT02666885|"~     The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the~     adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis~     the intention is to develop of a multi-parametric decision support system for personalised~     medicine by integrating functional imaging, γH2AX-analysis and genetic information.~   "
29813|NCT02666872|"~     Vaccination greatly reduced mortality and morbidity from many preventable diseases. However,~     to avoid the resurgence of these diseases and the human drama associated, high vaccine~     coverage should be maintained in the population. Yet in Quebec, vaccine coverage (VC) in~     young children remains suboptimal, especially caused by a proportion of parents who are~     ambivalent about the safety and effectiveness of vaccines. In this context, the Provincial~     Immunization Committee developed in 2010 a Quebec's immunization promotion plan.~      Therefore, our research team tested and validated across the Eastern Townships, a~     vaccination promotion concept by means of an educational intervention within maternities,~     based on motivational interviewing techniques. This intervention has not only significantly~     increased the intention of vaccination (+15%) within parents who had received the~     intervention but also increased their child vaccination coverage (+7.5% at 7 months). This~     is the purpose of the PROMOVAQ study (PROmotion of VAccination in Quebec) This research~     project evaluated the impact of an educational strategy based on motivational interviewing~     techniques within maternity ward on infants' VC. This strategy has been tested through a~     provincial study (Montreal, Quebec, Sherbrooke) including more than 2500 families.~      At term, this research program will offer the Quebec's Health Ministry an optimal strategy~     for immunization awareness so that Quebec's children may grow healthy and thrive.~   "
29814|NCT02666859|"~     The proposed project is to develop an effective prosthetic training and rehabilitation~     regimen, with the use of virtual reality, to return patients to the highest level of~     independence and functioning possible. The Computer Assisted Rehabilitation Environment~     (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life~     situations while providing real time visual feedback of their motion to improve the training~     and rehabilitation of upper limb prosthetic users.~   "
29815|NCT02666846|"~     This is a randomised, double blind, cross over clinical study in healthy human volunteers~     (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in~     a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three~     different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active~     control(s) in a model of UV-induced inflammatory pain.~   "
29816|NCT02666833|"~     The purpose of the study is to evaluate the ability and efficacy of using a~     polarization-enhanced reflectance and fluorescence imaging device, PERFIS, (see the Device~     Brochure) for demarcation of nonmelanoma skin cancer margins prior to surgery. PERFIS is a~     harmless and non-invasive device that has been used to image biological tissue both in vitro~     and in vivo. In this study it will be used to image nonmelanoma skin cancer lesions prior to~     surgery. The use of PERFIS will not affect patient care or treatment decisions in any way.~     No extra tissue will be used for imaging.~   "
29817|NCT02666820|"~     Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been~     increasingly accepted as alternative method for removal of large bile duct stones. However,~     there were limited studies comparing the efficacy of EST in combined with LBD to EST with~     mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of~     combined EST- LBD versus EST-ML in the removal of very large bile duct stones.~   "
29818|NCT02666807|"~     This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear~     Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other~     half will receive placebo.~   "
29819|NCT02666794|"~     The combined spinal-epidural analgesia during the labor has been associated with changes in~     fetal heart rate, which the opinions in literature are not fully consolidated and some~     studies have failed to show an increase significant fetal bradycardia following the~     combination lock. In addition, it's not clear that these changes found may modify the~     perinatal outcome in pregnancies who attend with intrauterine growth restriction (IUGR),~     since there are no studies comparing the techniques in this population.~   "
29820|NCT02666781|"~     Patients with obstructive sleep apnea (OSA) are more likely to experience postoperative~     complications and impact significantly on healthcare resources. In the surgical population,~     the type and volume of IV fluid administration may contribute to the worsening of~     postoperative sleep apnea but the pathophysiological mechanisms have not been elucidated.~     Recent research from general population suggests that intravenous (IV) fluid administration~     worsens the severity of OSA by shifting of fluid from the legs to the neck thus increasing~     neck size and causing airway collapse. In this novel study, our objective is to examine the~     contribution of IV fluid administration and rostral fluid shift from the legs to the neck~     thereby leading to worsening of sleep apnea following surgery. In this prospective~     observational cohort study, 25 consecutive adult patients, requiring at least 2 days~     hospital stay, will be recruited. Following informed consent, patients will undergo portable~     home sleep study to determine the preoperative severity of sleep-disordered breathing. On~     the day of surgery, leg, neck and total body fluid volumes will be recorded, and patients~     will undergo general anesthetic. The results of this study will be used to design future~     clinical trials evaluating methods to decrease postoperative OSA worsening, as well as~     decreasing OSA-related postoperative complications.~   "
29821|NCT02666768|"~     This study evaluates the effects of ACTIMMUNE (IFN-γ1b) in children and adults with~     intermediate osteoporosis. All participants will receive treatment with ACTIMMUNE for 12~     months. The investigators hypothesize that ACTIMMUNE will be tolerated by participants for~     the full 12 months and result in decreased disease severity.~   "
32973|NCT02625467|"~     The purpose of this study is to evaluate the visual results of patients with keratoconus~     treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer~     laser assisted lamellar keratoplasty (PALK).~   "
29822|NCT02666755|"~     The purpose of this study is to investigate the sensitivity，specificity and concordance rate~     of EGFR testing results in plasma in comparison of results in matched tumor tissues tested~     by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our~     findings in plasma with survival of advanced patients.~   "
29823|NCT02666742|"~     The purpose of this study is to learn if taking a drug called Apixaban after an ablation~     procedure keeps blood clots from forming and lowers the chance of having a stroke in~     patients with ventricular tachycardia (VT).~   "
29824|NCT02666729|"~     The purpose of this study is to collect information about the success rate of atrial~     fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz~     ablation catheter.~   "
29825|NCT02666716|"~     The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to~     non-ICU patients. The investigators will determine fluconazole and free fluconazole~     concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care.~     Switching to oral/enteral fluconazol is allowed after day 3.~      A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited~     pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels~     will be taken daily after intravenous therapy.~   "
29826|NCT02666703|"~     The modern era of cardiac surgery began in early 1950s with the introduction of~     cardiopulmonary bypass (CPB). Although it has been clearly shown that CPB is almost~     unavoidable for most open heart operations, an undesirable systemic inflammatory response~     syndrome (SIRS) is associated with its use. This complex chain of events has strong~     similarities with sepsis and may contribute to the development of postoperative~     complications and multiple organ failure (MOF). It has been shown that an excessive~     compensatory anti-inflammatory response (CARS) after SIRS can lead to immune paralysis and~     increased rate of hospital acquired infection. The balance of pro-inflammatory and~     anti-inflammatory mediators determines the inflammatory response and the clinical outcome.~     Accordingly, great efforts have been focused on therapeutic interventions aimed at reducing~     the inflammatory reactions during CPB, including pharmacologic strategies and modification~     of surgical techniques or mechanical devices. Such therapies may provide improvements in~     patient outcome after open heart operations. Among pharmacologic strategies is the~     prophylaxis with corticosteroids, which have been used during open heart surgery for more~     than 30 years. Many studies, both experimental and clinical, failed to produce evidence in~     favor of steroid treatment. As far as medical devices are concerned, the use of~     extracorporeal cytokine filter CytoSorb looks promising in cardiac surgery. It was recently~     approved by European Medicines Agency as an active treatment to fight cytokine storm.~      Serum paraoxonase 1 (PON1) is a lipo-lactonase, being associated with HDL that has an~     anti-inflammatory role and protects against atherosclerosis. Low levels of PON1 are~     associated with venous graft occlusion in patients with coronary artery bypass grafting.~     PON1 reduces monocyte chemotaxis and adhesion to endothelial cells, leading to inhibition of~     the differentiation of monocytes into macrophages. The effects of cytokine adsorption~     therapy on PON1 are unknown.~      The aim of the study is to explore the effects of extracorporeal immunoadsorption during CPB~     on pro-inflammatory and anti-inflammatory protective mediators and cellular immune status in~     cardiac surgery.~   "
29827|NCT02666690|"~     RECIST criteria for evaluating tumor response are often inadequate for the evaluation of~     anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced~     ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response~     through the analysis of 7 different parameters. Several studies (four at IGR, involving 117~     patients, and a multicenter study involving 400 patients) showed that CEUS allows early~     evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly~     interesting for the early identification of patients responding (or not) to treatment. Those~     are area under curve , and area under the wash-out. To further validate the use of these~     parameters, it is essential to measure and describe the level of their intra-patient~     variability.~   "
29828|NCT02666677|"~     This study is an online survey asking for invasive instrumention in trauma patients of an~     emergency department~   "
29829|NCT02666664|"~     The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated~     versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that~     is not adequately controlled by their current therapy.~   "
29830|NCT02666651|"~     Low blood sodium is a common observation in patients presenting with heart failure and is~     associated with increased mortality, prolonged hospital stay, and repeat hospital visits.~     Tolvaptan is a new and approved medication to treat low sodium levels in patients who~     present with symptoms of heart failure, however, it is not currently available as a~     treatment option due to high costs not covered by our provincial plan. In this~     observational, non-randomized study the drug will be provided to all subjects free of charge~     and given only during their hospital stay. After discharge subjects will be followed for 6~     months (3 visits).~   "
29831|NCT02666638|"~     The objective of this study is to determine whether these new image acquisition strategies~     and techniques using of up to 7T can produce meaningful structural and physiological~     information that can serve to improve our understanding of various disease processes in the~     clinical setting. 200 Control volunteers will be scanned for approximately one hour, without~     contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly~     developed imaging software or hardware that conforms to applicable FDA standards and~     recommendations. The data (images) for the Control and Experimental Group will be~     de-identified by the scan technologist and downloaded to a workstation within the Radiology~     Department for offline processing. These images will be reviewed by a trained Radiologist~     after the subject has departed.~   "
29832|NCT02666625|"~     The constitution of a biological samples bank, attached to epidemiological studies Cohort~     F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic~     variants that can modulate the iatrogenic risks of these treatments. The main objective is~     to provide a biological samples bank to consider, besides the carcinogenic risks, the risk~     of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular,~     lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal.~     Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made~     in relation to the treatment received in childhood. The overall project is expected to~     eventually better define the iatrogenic effects prevention strategies for cancer treatment.~   "
29833|NCT02666612|"~     Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called~     CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly~     treated with targeted therapy.~   "
29853|NCT02666352|"~     This is a 2-part, non-randomized, open-label, single-dose study to evaluate the~     pharmacokinetics (PK) of MK-3682, its metabolites M5 and M6, and ruzasvir (MK-8408) in~     participants with moderate hepatic insufficiency (HI) (Part 1) and in participants with~     severe HI (Part 2) compared to those in matched healthy particpants.~   "
29834|NCT02666599|"~     The objective of the study is to evaluate the sensibility of the probe Forimtech to detect~     β+ emission in vivo in humans and its usefulness during elective surgical procedure~     Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions~     sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive~     surgery or complement of resection of tumors.~      The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by~     the 18F-FDG.PET/CT~   "
29835|NCT02666586|"~     To describe the effect and mechanisms of action faba bean powder and fractions (protein,~     starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic~     regulation in young adults (18 to 30 years).~   "
29836|NCT02666573|"~     27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this~     randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline,~     probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding~     on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected~     to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites~     received subgingival instrumentation and rubber cup polishing with pumice. In addition test~     sites received a single application of PDT using Fotosan® and photosensitizer consisting of~     toludine blue O solution. The subjects were recalled three and six months later and~     re-examined. Site level analysis was performed.~   "
29837|NCT02666560|"~     To determine the clinical efficacy of auditory cueing using a cross over design to~     investigate whether increasing auditory cueing frequency by 20% above self paced cadence~     affects gait parameters in children with Cerebral Palsy when performing a functional task.~   "
29838|NCT02666547|"~     This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of~     neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or~     18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent~     tumor.~   "
29839|NCT02666534|"~     Surgical excision is the standard treatment for cutaneous SCC. However, many patients~     diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser-~     assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional~     Methylaminolevulinate (MAL)-PDT.~   "
29840|NCT02666521|"~     Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency~     of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes,~     particularly in relation to the clinical use of individual therapies in primary care.~      The aim of this study is to provide robust data on the frequency and severity of~     hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore~     associated risk factors.~   "
29841|NCT02666508|"~     Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and~     plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular~     disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with~     targetol technology (TM)), afforded the unique opportunity to test whether there were~     statistically significant and clinically important reductions in plaque and inflammation in~     a randomized trial of apparently healthy individuals.~   "
29842|NCT02666495|"~     A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical~     trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is~     therefore a need to test new treatments to find more effective treatments. Clinical trials~     of Schema Therapy have shown low rates of dropout, which is often a problem in the treatment~     of anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30~     sessions, has been shown to be effective for other complex mental health problems.This pilot~     study is therefore designed to pilot the use of individual Schema Therapy for people with~     Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer~     the principal research question: Does individual Schema mode Therapy, adapted for eating~     disorders, have the potential to improve symptoms, quality of life and weight in people with~     moderate-severe anorexia nervosa? It will also address secondary research questions: Can~     people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study~     of iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship~     between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome?~     Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a~     specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema~     Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional~     medical or dietetic management required. Standard outcome measures will be collected at 6~     month intervals. The research team have expertise in eating disorders research, schema~     therapy for severe anorexia nervosa and are all members of the local clinical service. The~     study will take place over a 3 year period.~   "
29843|NCT02666482|"~     The Institute for International Internet Interventions for Health (i4Health) at Palo Alto~     University proposes to develop digital tools specifically designed to help low income~     English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether~     a mobile-based digital intervention designed with systematic input from low-income English-~     and Spanish-speaking smokers from a public sector health care system can significantly~     improve its acceptability, utilization, and effectiveness. Using human-centered development~     methods, the project will involve low-income patients of the San Francisco Health Network in~     the design of a web app/text messaging tool. The investigators will also use participants~     input to improve the recruitment and dissemination strategies. i4Health will join forces~     with the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University~     to iteratively develop successive versions of the digital interventions informed by our~     human-centered approach.~      The full study involves 4 successive outcome studies testing the effectiveness of the Stop~     Smoking San Francisco web app.~      The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month~     follow-ups. These will test gradually improved versions of the app.~      The fourth study will involve a randomized trial comparing the initial version (the baseline~     version) of the web app to the final version of the web app, to determine if the final~     version is significantly better than the baseline version in terms of increased utilization~     and abstinence rates.~      To join this study, go to: https://stopsmokingsf.org~   "
29861|NCT02666248|"~     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received~     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol~     have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv~     Chimeric Antigen Receptor (CAR).~   "
29928|NCT02665364|"~     The safety and immunogenicity of the IFN-Kinoid (IFN-K) have been evaluated in a phase I~     clinical study conducted in subjects with SLE. Preliminary results were promising.~      The principal aim of the present study is to confirm the neutralization of the interferon~     gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the~     immune responses and the safety elicited by IFN-K will also be evaluated.~   "
29844|NCT02666469|"~     Stroke is one of the leading causes of disability and death in North America and Europe. Up~     to 30% of stroke survivors never recuperate completely and suffer from loss of function and~     poor quality of life. To improve recovery after stroke, innovative interventions should be a~     priority.~      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a~     hyperbaric chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing~     body of evidence that HBOT can enhance ability of brain to changes its structure~     (neuroplasticity) in order to recover. Exercise program during HBOT can augment the effect.~     Although, recent randomized controlled trials in patients with chronic brain injury showed~     promising results, there are no studies demonstrating combine effect HBOT and exercise~     rehabilitation program on stroke recovery.~      The proposed study investigates feasibility, safety and efficacy of using a combination of~     HBOT and exercise program to improve arm function recovery in chronic stroke patients. In~     this pilot randomized control trial, investigators will compare the combination of HBOT and~     the focused rehabilitation exercise program versus exercise program alone on recovery of arm~     function in patients with chronic stroke.~   "
29845|NCT02666456|"~     Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by~     quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk~     factors for neuropathic pain development and chronification in painless and chronic pain~     patients.~   "
29846|NCT02666443|"~     Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted~     side effects. Single shot blocks with local anesthetic alone usually do not last the~     duration of the acute post-surgical pain period. This has led to the exploration of multiple~     adjuvants to increase the duration of single shot blocks, the most promising adjuvant being~     dexamethasone.~      Peri-neural administration is an off-label use of dexamethasone. While no adverse events~     have been reported in human clinical studies, logic would dictate that we minimize the dose~     needed to produce the desired effect. Most studies thus far have used peri-neural~     dexamethasone doses ranging from 4-10 mg. However, Albrecht et al. found no difference in~     block duration comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block~     duration using doses of 1, 2 and 4 mg.~      Recent studies have evaluated whether systemic and peri-neural administrations of~     dexamethasone are equivalent, which would in turn imply a site of action. Results have been~     mixed. Four studies concluded peri-neural and intravenous administration are equivalent at~     prolonging analgesia, though one study had methodological errors, including the~     administration of intravenous dexamethasone to all patients. All of these studies used~     dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that~     peri-neural administration prolonged block duration whereas intravenous did not.~      With that, the rationale of our study is to determine if equivalent block-prolonging~     analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or~     intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20~     mL produces similar block duration to that reported in published studies using higher doses.~   "
29847|NCT02666430|"~     The aim of this extension study is to assess the safety and efficacy of Mylan's insulin~     glargine and Lantus® in T1DM patients.~   "
29848|NCT02666417|"~     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia~     (IDA), which adversely affects their growth and cognitive development. In-home iron~     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for~     IDA. However, in areas with a high burden of infectious diseases iron may increase the risk~     of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus,~     there is an urgent need to find safer formulations of iron fortification for African~     infants. The investigators recently finished a randomized, double blind controlled~     intervention trial in Kenya where the investigators tested whether the addition of~     galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse~     effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov~     Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron~     absorption. Therefore, to complement the intervention study, the present study will compare~     iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate~     (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80~     Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize~     porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with~     MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two~     consecutive mornings, and will consist of maize porridge containing isotopically labeled~     FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen~     days after the second test meal administration, a whole blood sample will be collected by~     venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be~     determined at baseline and endpoint. A stool sample will be collected at baseline and on the~     first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed.~     Knowing the expected iron absorption from the iron and GOS containing MNP will inform~     decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron~     dose to be used but still cover the infant requirement for absorbed iron.~   "
29849|NCT02666404|"~     Volume resuscitation is the mainstay of treatment in most types of shock, especially in~     hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality~     worldwide. Although there has been a lot of research to evaluate optimal amount and~     composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell~     transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain~     inconclusive and to some extent contradictive. The investigators would like to contribute to~     the establishment of new endpoints for the guidance of shock therapy focusing on the first~     24 and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate,~     blood pressure, central venous pressure) with new measurements (see study specific~     measurements). The goal is to decrease the need for renal replacement therapy, thereby~     eventually reducing patient morbidity and mortality.~   "
29850|NCT02666391|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.~   "
29851|NCT02666378|"~     This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a~     method of detecting early signs of damage to the heart that can be associated with adjuvant~     therapy of anthracycline (doxorubicin)-based combination chemotherapy followed by treatment~     with herceptin (trastuzumab for the treatment of (HER+) breast cancer.~   "
29852|NCT02666365|"~     Patients undergoing an elective ventral hernia repair will be randomly assigned to receive~     either bolus infusion or continuous infusion of the cefazolin as the prophylactic~     antibiotic. The blood concentrations of unbound cefazolin would be measured in their blood~     samples and the levels compared within the two groups with respect to their minimal~     inhibitory concentration (MIC) value.~   "
43563|NCT02486796|"~     This study is examine the effect of the addition of naturopathic on immunologic and/or~     inflammatory parameters and/or quality of life in women receiving neoadjuvant chemotherapy~     for breast cancer.~   "
29854|NCT02666339|"~     Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry,~     because of decompensation. That is why therapeutic treatments are delivered quickly to~     treat these symptoms and to allow a better relationship with patients. This relationship~     patients-nursing staff called therapeutic alliance is needed in psychiatry. Moreover,~     other treatments added to the therapeutic ones are used, like mediation, to increase the~     patients' state of health.~      These last years, numerous studies were based on hortitherapy or care-gardens. It consists~     in the use of plants with a medical staff (for example nurses). A lot demonstrated the~     efficacy of the care-gardens, but most of them showed methodological weaknesses.~      That is why the investigators would like to perform a randomized study, controlled, and they~     aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult~     psychiatry for at least 4 weeks.~   "
29855|NCT02666326|"~     Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial~     infarction (AMI). The majority has other explanations of their chest discomfort and most are~     discharged again without any initiation of treatment. Still, the suspicion dictates acute~     ambulance deployment, hospital admission to a highly specialized cardiac unit, cardiac~     surveillance and cardiac troponin blood sampling. The novel biomarker copeptin, a byproduct~     of vasopressin production, is released immediately from the pituitary gland as part of the~     hormonal response to AMI. Peak concentrations are reached within the first hour. Previous~     studies have suggested the combination of copeptin and cardiac troponin for fast and~     reliable rule out of AMI. However, the blood sampling should be performed as soon as~     possible after symptom onset, preferably already during the prehospital phase.~      We aim, in an open randomized setting, to investigate the combined measurement of~     prehospital copeptin and in-hospital high sensitive cardiac Troponin T compared to the~     standard rule-out procedure of suspected myocardial infarction. We hypothesize that the~     combined measurement of prehospital copeptin and in-hospital high sensitive troponin T:~        1. Reduces admission time by 1.5 hours in patients where AMI is ruled out~        2. Reduces the time to disposition~        3. Is non-inferior compared to the standard rule-out procedure in relation to major~          adverse cardiovascular events.~        4. Is more cost efficient compared to standard diagnostic strategy~   "
29856|NCT02666313|"~     Regular exercise is a core component of the long-term management of people with axial~     spondyloarthritis (axial SpA). However, delivering long-term exercise programmes is~     unrealistic and unsustainable using traditional NHS services. Web-based physiotherapy, has~     been developed, a possible alternative service model to support people with axial SpA to~     exercise regularly however long-term compliance to the programme (12 months) needs to be~     established. The aim of this prospective cohort study is to assess the feasibility,~     sustainability and acceptability of a 12 month individualised web-based physiotherapy~     programme in people with axial SpA. Fifty people with established axial SpA, will receive 12~     months of individualised, remotely monitored, web-based physiotherapy. The primary outcome~     will be four weekly compliance rates with the programme over the 12 month period. Secondary~     outcomes (baseline, 6 and 12 months) will include function, disease activity, spinal~     mobility, quality of life, attitudes and motivations towards exercise, fitness, health~     status, employment, physical activity. The number of interactions with health care~     professionals and changes in medication will be documented. A subsample of the cohort will~     be interviewed at 6 and 12 months to gather participants' views of the web-based~     physiotherapy programme and factors influencing compliance with the programme.~   "
29857|NCT02666300|"~     Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory~     complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT)~     to decrease or to increase the complications of general anesthesia compared with~     Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different~     incidence of complications following general anesthesia between TaperGuard ETT and~     Cylindrical-shaped ETT under high endotracheal tube cuff pressure.~   "
29858|NCT02666287|"~     Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule and is in development for the treatment of chronic~     obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled~     corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting~     beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product~     in combination with BAT, for treatment of COPD.~      This study is an open-label, six-way crossover, single and repeat dose study to evaluate the~     systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the~     ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a~     single dose, and at the proposed clinical dose, following repeat doses.~      This study will consist of screening period, 6 treatment periods, and a follow-up visit.~     Each subject will have 3 periods in which they receive a single dose treatment regimen (3~     inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a~     single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of~     those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8,~     subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a~     minimum of 7-day washout between each treatment periods. All subjects will receive 9~     treatments and follow-up procedures will be done 7 14 days after the last dose.~      Forty eight healthy subjects will be enrolled into the study, such that approximately 40~     subjects complete dosing and PK assessments. The total duration of participation for each~     subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the~     GlaxoSmithKline [GSK] group of companies.~   "
29859|NCT02666274|"~     There are many bacteria that naturally live in our gut and are essential for good health.~     These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing~     vitamins, repressing the growth of harmful bacteria and defending against some diseases. The~     desirable bacteria that live in the gut are collectively known as 'gut flora', or more~     appropriately, as 'gut microbiota'.~      The less desirable resistant bacteria, however, can also be carried in a person's gut for~     prolonged periods of time and be found in the stools without causing illness. Persons that~     carry the resistant bacteria in the gut are known as carriers and they require no~     treatment. Knowing that a person carries resistant bacteria is helpful, because it will~     inform the choice of antibiotic if the person were to become unwell or had an intervention~     such as surgery in the future.~      There is some evidence that resistant bacteria found in the stools can sometimes be passed~     from one person to another and eventually make someone ill if they infect (invade) their~     body. The investigators do not know how often this may happen, or how much carrying~     resistant bacteria in the stools may facilitate the spread of resistant bacteria in the~     population. It is important to address these questions and study ways to stop the resistant~     bacteria from spreading to safeguard the efficacy of antibiotics.~   "
29860|NCT02666261|"~     This non-interventional study will collect data from routine diagnostics on HER2 testing of~     breast cancer in Germany.~   "
43564|NCT02486783|"~     Suriname is a small developing country in South America with a population of half a million~     people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished~     data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of~     infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In~     comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These~     numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In~     any case about 40 newborns that die each year of infection are a huge loss, also considering~     the small Surinamese community. Despite this overall idea on the impact of infectious~     disease in Surinamese neonates exact information regarding incidence, type of infection~     (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient~     antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes,~     morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g.,~     gestational age, sex, ethnicity) are lacking.~      From a clinical perspective, there is still a challenge to identify neonates with infection.~     Neonates are often admitted with ambivalent clinical symptoms and receive preventive~     antibiotics that are costly, promote pathogen-resistance, and have negative long-term~     effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment~     of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be~     used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture~     results is relatively rare (0.5-3% in the United States). This complicates decisions on~     duration of antibiotic treatment and hospitalization significantly, while no other~     biomarkers exist.~      The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of~     leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and~     sepsis. During infection they accumulate in the bloodstream as a result of shedding, which~     represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes~     called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal,~     pediatric and adult sepsis. The shedding process reflects a critical and active process in~     orchestrating interaction between leukocytes and the endothelium for an effective host~     response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs~     and their sheddases are subject to change during infection and sepsis. Additionally,~     compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and~     pediatric meningitis.~      To date, some evidence exists of changes in levels of cAMs during malaria (in children from~     Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those~     levels have never been assessed simultaneously with levels of their sheddases in blood or~     CSF as a diagnostic tool. We propose that this combined approach may provide more detailed~     information about the extent of inflammatory activation in neonates.While a balance in~     levels is maintained under resting conditions or mild (local) infection, it may be perturbed~     during sepsis or meningitis . Thus, simultaneous measurement of these levels could promote~     early identification of infection, and may even distinguish between mild infection, systemic~     infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology~     as an advanced, fast, high-throughput and clinically feasible bedside tool for such an~     approach.~      We hypothesize that incidence rates of neonates with infection in Suriname are high. We~     further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and~     their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim~     to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of~     infection to establish incidence rates of infection, and 2) investigate diagnostic potential~     of our proposed biomarker combination in these neonates for infection, type of infection~     (e.g., local (mild), sepsis or meningitis) and outcomes.~   "
29862|NCT02666235|"~     Intermittent arm cuff inflation reduces the extent of heart muscle injury at the time of~     cardiovascular injury. The intervention is known as remote ischaemic conditioning (RIC)~     however the mechanisms by which RIC acts are incompletely understood.~      One mechanism that might explain the benefits of RIC is an improvement in coronary artery~     function which in turn might help improve blood flow to heart muscle.~      The investigators will perform a randomised controlled study of RIC in a minimum of 60~     patients with known or suspected angina and in whom coronary angiography with angioplasty~     would be considered.~      Following informed consent before the invasive procedure, the patient will be randomly~     assigned to the intervention group (cuff inflation protocol) or the control group (cuff~     placement, no inflation; sham protocol). Following initial coronary angiography, endothelial~     function will be assessed by intra-coronary infusion of acetylcholine in incremental doses.~     Coronary diameter will be measured after the procedure using quantitative coronary~     angiography, by a trained observer blinded to the allocated group. Since a neuro-hormonal~     response may potentially mediate RIC, a blood test will be performed before and after cuff~     placement in all patients (active and control groups) to measure circulating molecules known~     to regulate blood vessel function which may be implicated in a RIC-mediated effect on~     coronary artery tone.~      This study may provide clinically relevant insights into the mechanisms of action of RIC in~     patients with coronary heart disease.~   "
29863|NCT02666222|"~     The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem®~     Hearing Implant in subjects suffering from moderate to severe hearing loss.~   "
29864|NCT02666209|"~     Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are~     currently participating in a clinical trial which is closing. This research study is~     studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657~   "
29865|NCT02666196|"~     This is a placebo-controlled randomized phase 1 study to investigate the safety and~     pharmacokinetics of DAA-I in a cohort of healthy subjects.~   "
29866|NCT02666183|"~     This study seeks to test the effectiveness of two arms of an intervention that use~     videoconference technology for distance caregivers of patients with advanced cancer. The~     study is significant because the intervention will promote involvement of caregivers of~     patients with cancer and makes a compelling case for significance based on changing~     demographics and lifestyles.~   "
29867|NCT02666170|"~     The aim of our study is to investigate the effects of six months treatment with alpha-lipoic~     acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual~     pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral~     glucose tolerance test and hormonal assays are evaluated before and after therapy.~   "
29868|NCT02666157|"~     1. The recent development of novel oral anticoagulants (NOACs), including direct thrombin~          inhibitor (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban),~          could potentially overcome many drawbacks of warfarin, and might provide a safer, and~          even more effective and convenient alternative approach to warfarin in non-valvular~          atrial fibrillation (NVAF), especially in Asians.~        2. According to the results of a meta-analysis comparing Asians and non-Asians, NOACs are~          preferentially indicated in Asians in terms of both efficacy and safety.~        3. There is no randomized controlled trial with sufficient power to directly compare the~          efficacy and safety among NOACs in NVAF, not to speak of Asians and Chinese.~        4. Indirect comparisons are only based on observation with a lot of limitations such as~          heterogeneous background characteristics, difference in study design, and diversity in~          time within therapeutic range in control group. The findings from indirect comparisons~          are not conclusive but only hypothesis-generating.~        5. This investigator-initiated prospective randomized open blinded end-point clinical~          trial will directly compare the efficacy and safety among 3 NOACs in patients with NVAF~          in Taiwan. We hypothesize that rivaroxaban or apixaban is non-inferior to dabigatran in~          terms of the efficacy.~   "
29869|NCT02666144|"~     This prospective, monocentric, non-invasive clinical study is designed to measure normal~     structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer,~     and the macula using the Heidelberg Spectralis OCT device. This study is conducted in~     normal, healthy volunteers and glaucoma patients. The main goal of the study is to provide~     an analysis of the comparability of these parameters between two different software versions~     and their respective method of scan centration on the optic disc center. The study will~     include at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma~     patients. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic~     examination, and visual field testing in one single visit. Total study duration (first~     patient first visit to last patient last visit) is anticipated to be approximately 4 weeks.~   "
29870|NCT02666131|"~     The purpose of this study is to determine whether Granexin gel is safe and effective in the~     treatment of diabetic foot ulcers.~   "
29871|NCT02666118|"~     Nerve blocks, or pain medication injected next to the nerve while patients are asleep, are~     commonly used for pain management after shoulder surgery and are considered highly effective~     in decreasing post-operative pain. There are several different ways to give a nerve block.~     All are effective and safe. The purpose of this research is to determine if one of the~     available ways to give a nerve block is more effective than the others.~   "
29872|NCT02666105|"~     This is a phase II single institutional therapeutic study of exemestane in post-menopausal~     women with advanced non-small cell lung cancer (NSCLC) who have failed at least 1, but not~     more than 3 previous treatment regimens.~   "
29885|NCT02665923|"~     Ultrasound imaging will be used to (1) evaluate gastric antral volumes in children~     presenting for anesthesia who have been fasted, and (2) to evaluate time for gastric~     emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or~     milk (including breast or formula).~   "
29886|NCT02665910|"~     Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo~     comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel~     Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized~   "
29974|NCT02664766|"~     The purpose of this research is to examine the effects of long-term aerobic exercise of~     moderate intensity on psychological, physiological, biochemical, physiological and~     alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical~     mechanisms by which exercise may be a healthy alternative to alcohol abuse.~   "
29873|NCT02666092|"~     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them~     are recognized as zoonotic diseases agents, and have a high impact on human health.~      Infestation results from the ingestion of living larvae from contaminated fishes. It can be~     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.~     Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms~     can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or~     cooked fish, and may masquerade as fish allergy.~      In this study, we aim to characterize the relationship between Anisakidae and/or fish~     sensitization and the presence of allergic manifestations in patients recruited in the~     general population and presenting fish allergy resulting from ingestion, cutaneous or~     respiratory contact. We will also determine the respective role of Anisakidae or fish~     sensitization in patients with fish allergy. Then, we will determine the prevalence of~     previous Anisakidae infections among these patients and a matched control population. We~     will also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis~     and Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will~     explore the relationship between domestic exposure to Anisakidae or fish antigens and the~     occurrence of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae~     infection).~   "
29874|NCT02666079|"~     This study is a prospective, randomised, controlled multi-centre study to examine outcomes~     following wide local excision (WLE) for breast cancer with (treatment arm) or without~     (control arm) intra-operative use of the LightPath™ Imaging System.~      The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath™ Images will be used to inform~     the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer~     surgery and complete tumour excision with clear WLE resection margins.~      Study sites will use the local criteria considered standard of care to guide decisions to~     act on positive margins.~      In the LightPathTM arm the resection margin status of the WLE specimen, cavity shavings (if~     any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the~     LightPath™ Imaging System will be compared with histopathology results.~   "
29875|NCT02666066|"~     Radiomics, the extraction of large amounts of quantitative image features to convert medical~     images into minable data, is an in-development field that intends to provide accurate risk~     stratification of oncologic patients. Published prognostic scores only take clinical~     variables into account. We hypothesize that a combination of CT/MRI features, molecular~     biology and clinical data can provide an accurate prediction of medical outcome. The long~     term objective is to build a Decision Support System based on the predictive models~     established in this study.~   "
29876|NCT02666053|"~     The purpose of this study is to estimate the effect of high fat meal and increased gastric~     pH on BMS-663068 bioavailability~   "
29877|NCT02666040|"~     With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to~     investigate the benefits in terms of incidence of pain and discomfort, improvement in the~     quality of life for the patient after the use of the newly introduced semi-absorbable~     prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material~     (conventional meshes in polypropylene Prolene®), and in terms of the costs for the~     hospital, the National Health System (NHS), and the society of associates for the use of the~     ULTRAPRO® in inguinal hernia surgeries.~   "
29878|NCT02666027|"~     This study is being performed to determine the effectiveness of Fluid Intravenous Alert~     (FIVA) in monitoring intravenous fluid delivered to patients under anesthesia in a dimmed~     ambient light in the operating room.~   "
29879|NCT02666014|"~     The laparoscopic technique is commonly employed for abdominal gynaecological surgery in~     women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing~     gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the~     incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after~     anesthesia and is one of the most common causes for unexpected hospital admissions in~     day-surgery.~      Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle~     relaxation producing drugs that are commonly used during surgery. Neostigmine has been the~     drug of common use for this purpose, but PONV is reported with its usage.~      With this research we intend to determine whether the trial drug Sugammadex would reduce the~     incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery~     when compared to Neostigmine.~   "
29880|NCT02666001|"~     The study is being conducted to assess the effect of multiple doses of BMS-663068 on the~     exposure of methadone in subjects on a stable dose of methadone, and the exposure of~     buprenorphine and norbuprenorphine in subjects on a stable dose of Suboxone.~   "
29881|NCT02665988|"~     Transcranial direct current stimulation (tDCS) is an investigational device that has not~     been approved for the treatment of any medical condition by the FDA but is allowed to be~     used for research purposes. In clinical trials tDCS has been associated with pain relief by~     decreasing the intensity and duration of chronic pain. tDCS potentially works by stimulating~     the brain by delivering an extremely low-level electrical current to areas below the~     forehead - areas associated with chronic pain. It is anticipated that this current will~     increase brain activity or the likelihood of brain activity in these areas, affecting~     individual's ability to regulate pain.~      The purpose of this study is to compare eligible participants in the Pain Management Program~     at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation~     (tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary~     objectives are: (1) improving pain tolerance and (2) improving subjective pain experience.~     Secondary objectives are: (1) improving subjective experience of sleep quality and (2)~     increasing physical activity.~   "
29882|NCT02665975|"~     The purpose of this study is to compare the effectiveness of a CBT-based internet~     intervention with face to face standard clinical care for adults with tinnitus in the United~     Kingdom.~   "
29883|NCT02665962|"~     80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data~     have shown that caloric restriction (CR) protects against organ injury and decreases~     perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week~     perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed~     endometrial cancer patients. The intervention will provide individualized CR program, meal~     replacement products and nutritional counselling sessions.~   "
29884|NCT02665936|"~     The purpose of this study is to detect whether the addition of epidural dexamethasone will~     prolong labor analgesia.~   "
29887|NCT02665897|"~     In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney~     impairment characteristics, a recent study demonstrated that the serum levels of NGAL~     increased at the end of the second trimester in women who subsequently developed~     pre-eclampsia compared to the control group.~      This correlates well with the endothelial damage that occurs during pre-eclampsia and thus~     NGAL can be considered as a promising marker in predicting both early and late onset~     pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the~     precision, and sensitivity for detection of risk and reliability of using biomarkers for~     pre-eclampsia.~   "
29888|NCT02665884|"~     Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients~      Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Open-angle~     glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level~     that the physician believes will prevent further glaucomatous damage. However, in a~     significant proportion of patients, the visual fields continue to deteriorate in spite of~     office pressures within the range of normal values (8). It has been suggested that the~     progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability~     not detected by tonometry during office hours. It is possible that certain drugs or surgical~     interventions are more effective than others in dampening these fluctuations. The purpose of~     our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with~     medications or Ex-press filtration surgery.~   "
29889|NCT02665871|"~     This study evaluates the safety of freeze-dried live attenuated influenza vaccine for~     intranasal administration in chinese adults aged 3 years and older.80 subjects will be~     divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each~     groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.~   "
29890|NCT02665858|"~     Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides~     therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it~     remains a limited method of producing quantitative data in evaluating in patients with IIH.~      In this study we intend to compare, by using spectral domain optical coherence tomography~     (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT)~     of the optic nerve of newly diagnosed IIH children to a control group. This will provide a~     quantitative measure for follow-up and treatment of this patient group.~   "
29891|NCT02665845|"~     The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well~     established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA)~     agents in the form of mesalamine/mesalzine are well established proven therapy in~     mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA~     was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most~     cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is~     usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until~     the flare is controlled. If this is unhelpful, or if the flare is severe to begin with,~     corticosteroids are usually prescribed. However, there are very scarce data comparing~     steroids versus 5-ASA in the treatment of severe UC exacerbation.~      The aim of this study is to compare the efficacy of steroids alone vs. combination of~     steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.~   "
29892|NCT02665832|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics of~     combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male~     volunteers~   "
29893|NCT02665819|"~     PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and~     biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia~     Children's Hospital in Holland.~      Ensure optimal patient quality of life throughout his life is a priority for the research~     teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired~     quality of life. It is in this light that will be offered to patients a quality of life~     questionnaires during the period of treatment and then periodically during long-term~     follow-up.~   "
29894|NCT02665806|"~     This study is designed to compare ciclesonide nasal spray once daily with fluticasone~     propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal~     polyposis, in order to relieve symptoms of these patients.~   "
29895|NCT02665793|"~     Food allergy affects up to 10% of the population. The mainstay of management involves~     dietary avoidance and provision of rescue medication in the event of an accidental reaction.~     The Integrated approaches to food allergen and allergy management (iFAAM) collaboration is~     an EU-funded academic/clinical/industry consortium with the aim to improve allergen risk~     management including food labelling. Much of this work requires the validation of the~     minimum 'eliciting dose' for the food-allergic population and how this can be translated~     into risk management.~      A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the~     eliciting dose for peanut allergic patients, using food challenges where peanut-allergic~     individuals are eat incremental doses of peanut under strict medical supervision.~      In this extension study, peanut-allergic subjects will have undergone (in a cross-over~     manner) three double-blind, placebo-controlled food challenges to peanut:~        1. incremental doses of peanut in a water-continuous matrix;~        2. incremental doses of peanut baked into a cookie biscuit;~        3. a single dose of peanut in a water-continuous matrix.~      The differences in eliciting dose, symptom pattern and underlying physiological mechanisms~     will provide essential data on how the presentation and consumption of peanut affects the~     amount needed to trigger an allergic reaction, to inform industry and food regulators as to~     how to best protect the food-allergic population.~   "
29896|NCT02665780|"~     This study evaluates the short and long term effect of dental cleaning and mouthrinsing for~     the treatment of bad breath~   "
29897|NCT02665767|"~     The investigators investigated the feasibility of the clinical application of~     novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the~     appendix.~   "
29898|NCT02665754|"~     The investigators will perform double-blinded placebo-controlled randomized clinical trial~     which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy~     (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus~     (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients~     with allergic rhinitis (AR), using allergen extracts for allergen-specific immunotherapy~     (Tyrosine S, Allergy Therapeutic, West Sussex, UK).~   "
29901|NCT02665715|"~     Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing~     higher peak blood glucose concentration early after meal intake. In the late postprandial~     period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In~     some patients, overt postprandial hypoglycaemia develops, and is typically reported as a~     complication 1-5 years postoperatively, when maximal weight loss has been obtained. The~     pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of~     insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1~     (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole~     body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces~     postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive~     hypoglycemia prevented.~   "
29902|NCT02665702|"~     The aim of this study is to explore whether endostar combined with NVB and DDP as treatment~     could improve progression-free surial time (PFS) and to evaluate the safety of the~     chemotherapy regimens~   "
29903|NCT02665689|"~     The aim of the prospective randomized study is to investigate whether a intensified diabetic~     control program leads to better final visual acuity and less frequent diabetic ocular~     complications in patients with diabetic retinopathy when compared with a normal diabetic~     treatment.~   "
29904|NCT02665676|"~     The aim of this study is to investigate demographic & disease characteristics of pediatric~     cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the~     spectrum of these disease entities & treatment outcomes in these patients.~   "
29905|NCT02665663|"~     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis~     that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.~      Swallowing disorders occur during evolution and involve the prognosis of patients in the~     short term by the association of dysphagia with severe malnutrition, and aspiration. The~     issue of phoniatric monitoring is to detect early onset of the swallowing disorders to~     develop strategies for respiratory protection, food adapted to disturbances, and speech~     therapy.~      The objective of this study is to compare the tongue force in patients with amyotrophic~     lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared~     to healthy subjects, with the dynamic palatography device developed in the Laboratoire~     Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows~     the measurement of the strength and duration of the pression of the tongue on the palate.~   "
29906|NCT02665650|"~     The purpose of this study is to establish a dosing regimen for the combination therapy of~     AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin~     Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.~   "
29907|NCT02665637|"~     This is a double-blind, two-arm, parallel-group, single-dose study.~   "
29908|NCT02665624|"~     Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of~     the colonoscopy preparation regimens is safe, efficient and also comfortable. The~     investigators' aim was to determine whether adding stewed apricot juice to senna increases~     patient comfort and improves bowel cleansing during colonoscopy preparation.~   "
29909|NCT02665611|"~     Moma call center will provide unique service -Remote monitoring and support for mental~     health patients .The aim of this reserch is reducing hospitalization and improve adherence,~     by reaching out and there for monitoring very closely .~   "
29910|NCT02665598|"~     Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological entity, which~     is associated with a variety of clinical conditions. The imaging and clinical findings are~     typically reversible, but many patients still have permanent neurological sequelae with a~     fatal outcome. Up to now there are no consistent conclusions about the factors that~     affecting its prognosis. The objective of our study is to discuss the effects of different~     causes, different imaging findings and laboratory parameters on the prognosis of PRES and~     deepen the understanding of the nature of PRES. This will contribute to predict the~     prognosis of patients with PRES and to further investigate the pathogenesis of PRES so as to~     guide the clinical treatment and follow-up evaluation. A multi-center retrospective case~     study will be performed from January 2016 to July 2017 and a total of 400 patients who meet~     the criteria for PRES diagnosis from 10 sub-centers are anticipated included in this~     research. Patients will be divided into several subgroups according to the etiology. Date~     will be collected from the clinical records，imaging and laboratory data of the patients,~     including demographic data, clinical data, imaging findings, laboratory parameters and~     follow-up data. During the follow-up, MRI and blood biochemical examination will be~     performed once more. The imaging findings of the patients will be assessed by two~     neuroimaging physicians, any difference between them will be agreed upon by consensus.~     Prognosis of the patients will be assessed by using the modified Rankin scale (mRS) scores.~     All of the above data is saved into the database. In this study we will review etiologies~     and imaging findings, laboratory and follow-up data of the patients we selected. Univariate~     and multivariate analysis will be performed within the group and between groups according to~     the subgroups. Then we will discuss the connection between different causes, different~     imaging findings and laboratory parameters and the prognosis of posterior reversible~     encephalopathy syndrome.~   "
29911|NCT02665585|"~     The aim of the present positive-control study is to analyze and compare the rate of~     off-table subclinical neurological events in two groups of patients submitted to carotid~     artery stenting (CAS) with two different kind of stents, a close-cell stent, and the new~     mesh-covered stent, so to verify if the new model of stent is effective in preventing~     postprocedural carotid plaque embolism.~   "
29912|NCT02665572|"~     In this study, investigators will prospectively evaluate the outcome of renal~     transplantation into a defunctionalized bladder by comparing direct transplantation into~     this defunctionalized bladder and pre-transplant programmed bladder cycling.~   "
29913|NCT02665559|"~     Testosterone deficiency is classically associated with the development of metabolic~     syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome~     and alteration of the quality of patients life.~      Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss~     and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand,~     abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells~     causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular~     invasion by lymphoma or Kaposi's syndromes have also been described.~      The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients~     infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless~     of the antiretroviral therapy and CD4-T cell count.~      No study to our knowledge has so far assessed exhaustively the clinical features,~     biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level~     of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients~     in the European population.~   "
29975|NCT02664753|"~     The primary objective of this study is to compare 28 day mortality rates between septic~     shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct~     therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.~   "
29914|NCT02665546|"~     Pulmonary Langerhans Histiocytosis Cells (PLCH) is characterized by infiltration of~     Langerhans cells and formation of loose granulomas with lymphocytic infiltrate and formation~     of nodular and cystic lesions on chest CT, and is often associated with smoking.~     Functionally, there may be obstructive and / or restrictive defect, with reduced carbon~     monoxide diffusing capacity. Dyspnea and lower exercise tolerance are common in PLCH, but~     exercise capacity in this disease is poorly understood and has not been compared to~     controls. Besides, the mechanisms involved in limiting exercise are poorly understood and~     cover multiple factors such as change in gas exchange, pulmonary hypertension (PH), dynamic~     hyperinflation, physical deconditioning and left heart failure. The involvement of pulmonary~     circulation in PLCH has unknown prevalence, but contributes to the symptoms. In the PH~     classification, PLCH belongs to the group 5, of multifactorial etiology. The definition of~     the presence and contribution of dyspnea mechanisms in different severities of PLCH is~     important to understanding the disease and individualization of treatment. The objective of~     the study is to evaluate the exercise capacity of patients with HCLP, and determinate~     mechanisms of dyspnea and lower exercise tolerance beyond its impact on quality of life.~   "
29915|NCT02665533|"~     The main aim of the study is to investigate the pre-emptive effect of dexamethasone and~     diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the~     extraction of third molar.~   "
29916|NCT02665520|"~     Autologous Fat Derived Stem Cell treatment of ED.~      To assess safety and primary efficacy of stem cell infusion in refractory ED.~      To investigate the success rate and durability of success of using this new therapy in~     management of moderate and sever cases of erectile dysfunction.~   "
29917|NCT02665507|"~     Back pain is a common complaint among pilots. Current treatments include physiotherapy and~     chiropractic manipulations. Low-level laser irradiation (LLLI) in the visible to~     near-infrared range was shown to reduce neck and low back pain.~      The purpose of the study is to evaluate the efficacy of Light Therapy for treatment of back~     pain in pilots.~   "
29918|NCT02665494|"~     Multi-centric, observational, prospective study, designed for pts with diagnosis of~     all-stages cholangiocarcinoma, including rare and crossing-over histological types, and~     excluding gallbladder cancer and ampullary carcinoma.~   "
29919|NCT02665481|"~     The purpose of this research is to examine the effects of four interventions on age-related~     cognitive decline in healthy older adults. The investigators will examine the effects of~     Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based~     aerobic exercise, and their combination, compared to a discussion group.~   "
29920|NCT02665468|"~     On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge~     to create a single entity that will be responsible for the implementation and evaluation of~     eHealth technologies across the healthcare system. In an effort to successfully fulfill its~     mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an~     eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of~     eHealth technologies across VHA, and to measure their impacts on dimensions of access and~     other outcomes. Developed in close consultation with leadership of the new office, the~     proposed objectives of the eHealth PEI are to (1) implement a patient-level supported~     adoption intervention for secure messaging and evaluate the impact of secure messaging use~     through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's~     automated telehealth text messaging system to Veterans and clinical team members.~   "
29921|NCT02665455|"~     To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when~     used at home by pregnant women with diabetes.~   "
29922|NCT02665442|"~     This Study is designed to determine the outcome and effect of implementation of Esophageal~     Stylet as a strategy to minimize the risk of esophageal injury during the atrial~     fibrillation catheter ablation procedure.~   "
29923|NCT02665429|"~     This is a study of emergency physicians' prescribing patterns related to opioid (narcotic)~     medications. We are trying to determine whether giving providers access to their own~     prescribing data influences their prescribing patterns.~   "
29924|NCT02665416|"~     This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic~     activity of RO7009789 in combination with vanucizumab in participants with metastatic solid~     tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish~     the maximum tolerated dose (MTD) of RO7009789 in this combination. Part II (expansion) is~     intended to further characterize the safety and clinical activity profile of RO7009789 among~     indication-specific cohorts.~   "
29925|NCT02665403|"~     Hospitalization is a stressful and threatening experience, which can be emotionally~     devastating to children. Hospital play interventions have been widely used to prepare~     children for invasive medical procedures and hospitalization. Nevertheless, there is an~     imperative need for rigorous empirical scrutiny of the effectiveness of hospital play~     interventions, in particular, using play activities to ease the psychological burden of~     hospitalized children. This study tested the effectiveness of play interventions to reduce~     anxiety and negative emotions in hospitalized children. A non-equivalent control group~     pre-test and post-test, between subjects design was conducted in the two largest acute-care~     public hospitals in Hong Kong. A total of 304 Chinese children (ages 3-12) admitted for~     treatments in these two hospitals were invited to participate in the study. Of the 304~     paediatric patients, 154 received hospital play interventions and 150 received usual care.~   "
29926|NCT02665390|"~     This study is focus on percutaneous cryoablation,which was for the treatment of medically~     inoperable Peripheral lung cancer.The patients who were agreed to attend the study will~     accept the operation. After the operations,they will follow up according to the plan.~   "
29927|NCT02665377|"~     Prospective, blinded, placebo-controlled trial. Patients: Adult patients (>18 years of age)~     undergoing de novo Htx, with a preoperative GFR > 60ml/min, not receiving an~     ABO-incompatible organ with an ischemia time of > 6 hours. A donor age > 70 years is an~     exclusion criterion together with a severe intraoperative graft dysfunction causing~     intra-operative death or need for mechanical cardiac support.~      Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.~      Outcome: Kidney function, evaluated with serum creatinine and kidney clearance, 4-5 Days~     after Htx plus after 3 and 12 months.~   "
43565|NCT02486770|"~     This study will evaluate the safety profile and pharmacokinetic behavior of a single~     administration of Aerucin in healthy adults at three different dosages.~   "
29929|NCT02665351|"~     Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of~     uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have~     shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous~     therapy lies mainly with patients hospitalized with complicated diseases, such data are~     limited because of feasibility and ethical considerations for placebo-controlled studies.~      In this study, the investigators aimed to examine more specifically treatment effects of~     peramivir in adults hospitalized with influenza-associated lower respiratory tract~     complications (LRTC). Such findings may have important implications on clinical management.~   "
29930|NCT02665338|"~     Cigarette smoking causes significant morbidity and mortality in the United States. Smoking~     cessation is difficult, with the average smoker attempting to quit five times before~     permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain~     stimulation for smoke cessation is an exciting new area that builds on advancing~     neuroscience knowledge concerning the functional neurocircuitry of addiction. Cortical~     stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS).~     Several studies have shown that TMS can reduce cue-elicited craving in smokers. Previous~     research by group has shown that a single session of 15 minutes high frequency (10 Hz)~     repetitive TMS (rTMS) at 100% motor threshold over the left dorsal lateral prefrontal cortex~     (DLPFC) can reduce cue-induced craving compared to sham TMS. However, the mechanism by which~     craving is reduced by rTMS is poorly understood both at behavioral and neural levels.~     Neuroimaging studies in nicotine dependence have revealed cue-related responses in numerous~     brain areas, including frontal, parietal cortices and subcortical areas. Recently functional~     magnetic resonance imaging (fMRI) studies by the group have shown that cue-induced craving~     induced brain activation in ventral medial prefrontal cortex (VMPFC), including medial~     frontal, orbital frontal and anterior cingulate. This Chair Research Development Fund (CRDF)~     pilot proposal will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC~     pathway in smokers. Using double-masked methods investigators hypothesize that cue-induced~     exposure will induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce~     cue-induced craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and~     decreased activity VMPFC).~   "
29931|NCT02665325|"~     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has~     become the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid~     carcinoma is thyroid differentiated carcinoma（DTC）. Postoperative oral L-thyroxine~     suppressing thyroid stimulating hormone (TSH) treatment is the standard therapy in DTC~     patients. While TSH-suppressive therapy with L-thyroxine can cause subclinical~     hyperthyroidism in treatment of patients with thyroid differentiated carcinoma. The impact~     of this therapy on cognitive functions and mood have not been systematically studied. The~     investigators infer the subclinical hyperthyroidism caused by TSH-suppressive therapy may~     impact cognitive function and mood disorders in DTC patients. The aim of this study is to~     explore the possible mechanism of cognitive function impairment in the course of~     TSH-suppressive therapy by rat model of total thyroidectomy + TSH-suppressive therapy and~     clinical trials. The result of this study may provide clinical and experimental basis for~     the side effects risk result form TSH-suppressive therapy in DTC patients.~   "
29932|NCT02665312|"~     observational prospective study, designed for patients with colorectal cancer receiving for~     the first time 5-FU or capecitabine, with or without other chemotherapy combinations.~   "
29933|NCT02665299|"~     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may~     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This~     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory~     tests. Measurement of ctDNA has been shown to be useful for following patients with known~     cancer. It has also been found in the circulation of some patients with early stage cancer.~     The purpose of this study is to examine blood specimens for the presence of ctDNA in~     individuals without known cancer who are scheduled to undergo a screening or diagnostic~     colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition~     at a very early stage before the patient becomes symptomatic. The results of this study~     should help define the role of ctDNA in the detection of early stage colon cancer and to~     define how sensitive it is (i.e. how well it picks up cancer when it is present) and how~     specific it is (i.e. how often is ctDNA found in patients with benign diseases or no~     abnormalities).~   "
29934|NCT02665286|"~     Low back pain is a common cause of visit to emergency department. It is not clear if~     skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a~     randomized study to determine if skeletal muscle relaxants, when combined with naproxen,~     improve outcomes more than naproxen alone~   "
29935|NCT02665273|"~     This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using~     bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only~     enrolled if they fail first line therapy with metoclopramide.~   "
29936|NCT02665260|"~     The purpose of this study is to determine if cantharidin is a safe and effective treatment~     for molluscum contagiosum in kids~   "
29937|NCT02665247|"~     The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood,~     anxiety and well-being measures in a sample of college students. College students have a~     high prevalence of sleep problems including poor sleep hygiene, volitional sleep~     deprivation, and insomnia. Sleep disorders in college students negatively affect mood,~     social functioning, physical safety, and academic performance. Rarely recognized by the~     students themselves, these conditions are therefore often untreated. Participants in this~     study will be randomly assigned to receive the College Sleep Improvement Plan (C-SIP) or a~     control session. Participants will be asked to track their sleep as well as complete~     questionnaires; a subset of participants will be asked to wear an activity monitor.~   "
29938|NCT02665234|"~     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic~     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry~     eye disease.~   "
29939|NCT02665221|"~     The primary purpose of this single center, randomized, open label study in relapsing~     Multiple Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect~     of Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of~     injection site erythema after PLEGRIDY injection.~   "
29940|NCT02665208|"~     The primary purpose of this study is to understand the feasibility of a text messaging~     intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve~     smoking cessation among opiate and/or alcohol dependent participants discharged from an~     inpatient detoxification unit and enrolled in an office-based buprenorphine program patients~     (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of~     informational pamphlets and information for a 1800 quit line; and a prescription for a~     nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity~     of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which~     is offered routinely to all inpatients at Bellevue at the time of discharge) versus the~     SmokeFreeTXT intervention plus prescriptions for NRT.~   "
29941|NCT02665195|"~     This study is being done to learn more about how changes in certain genes may be linked to~     cancer. Some people with cancer got their disease because they inherited an abnormal~     (mutated) gene.~      The researchers of this study want to better understand the risks that are linked to genetic~     changes in these less well-studied genes. By understanding these risks, we believe that~     doctors will be able to give better advice to families with mutations in these genes.~   "
29942|NCT02665182|"~     This is a single-blinded RCT evaluating the value of up-positioning of the testes as~     supportive therapy in patients receiving antimicrobial treatment due to acute bacterial~     orchitis.~   "
29943|NCT02665169|"~     This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with~     free use of communal recreation facilities in fall prevention.~      Morbidity, use of social services and health outcomes of aging women in province of Kuopio,~     Finland are also monitored. The study combines a six months supervised exercise, followed by~     six months free, but unsupervised, use of recreational facilities and observational period~     of second year into total of 2 year follow up duration.~   "
29944|NCT02665156|"~     Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC)~     with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this~     procedure. According to a recent consensus panel, the benchmark for intracorporeal~     orthotopic neobladder should be 5 hours in high volume centers .~      This prospective single-stage phase 2 trial is designed to assess the time efficiency of~     using robotic stapler versus the conventional motorized staplers (Linear stapler articulated~     Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr).~      Perioperative complications (intraoperative and 30-d postoperative complications according~     to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates,~     early functional outcomes (time to recovery of urinary continence), 180-d and 360-d~     neobladder stone formation rates will be analyzed to assess the safety and the cost~     effectiveness of the procedure.~   "
29945|NCT02665143|"~     The purpose of this study is to determine if a combination of nintedanib+ induction~     chemotherapy can be an effective strategy for patients where outcome of relapse/refractory~     acute myeloid leukemia (AML) is poor.~   "
29946|NCT02665130|"~     Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese~     population but no data exist concerning metabolic responses to Tai-Chi in COPD patients.~     Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a~     Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian~     population. Classical western style pulmonary rehabilitation will serve as a comparator~     Investigators propose a prospective randomized controlled trial in which 120 bronchodilator~     naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 %~     of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to~     receive a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary~     Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province,~     China) will be recruited.~      Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural~     location in southern China (Xingning). A qualified UK Physiotherapist will also be involved~     in the management of pulmonary rehabilitation program to further make sure the high quality~     of pulmonary rehabilitation has been applied. Both arm participants will also receive in an~     open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups~     (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this~     study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol~     at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk~     distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The~     investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.~   "
29947|NCT02665117|"~     Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia,~     activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia,~     Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may~     interact with each other to contribute to the development of insulin resistances and~     metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit)~     can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia.~     This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of~     correction of hypokalemia.~   "
29948|NCT02665104|"~     The primary endpoint of our study is to determine whether neurological symptoms (aphasia,~     paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery,~     and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive~     regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters~     after the internal carotid artery is clamped, and if there is any difference between the~     operated and non-operated sides?~   "
29949|NCT02665091|"~     Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years.~     Studies in various countries show that both out of school and in school adolescents and~     youth are engaged in risky sexual behaviors. Peer-based interventions have become a common~     method to effect important health-related behavior changes and address the HIV/AIDS~     pandemic. This study therefore aimed to evaluate the effectiveness of peer education in~     improving HIV knowledge, attitude, and preventive practices among in-school adolescents~   "
30464|NCT02658357|"~     The study will be a 6-month, open-label, multiple center study in approximately 50 stable~     subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety,~     tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following~     implantation of two or three, 300 mg Risperidone Implants.~   "
29950|NCT02665078|"~     The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The~     ultrasound probe will be put on the lung surface in several different directions to obtain~     the cross section with maximum diameter. The ultrasound image with size measurement of the~     tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP.,~     Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized~     endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the~     lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images~     between deflated and inflated lung. After ultrasound evaluation, the specimen will be~     delivered directly to the pathology laboratory and the actual tumor size and histological~     diagnosis will be determined. In addition, we will evaluate the differences between US image~     and pathological morphology using HE slides of lung tumor. We will work together with the~     surgical team to confirm sign off of specimens.~   "
29951|NCT02665065|"~     The primary objective of this study is to demonstrate the efficacy of Iomab-B, in~     conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified~     allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.~   "
29952|NCT02665052|"~     Loss of arm use and strength are common problems after stroke that greatly affects~     independence in activities of daily living. Arm rehabilitation using robot-assisted~     repetitive task training has shown to improve motor recovery. However, this type of exercise~     cannot be done at home as these devices are large and expensive. This study will test~     whether a more portable, less costly, non-robotic repetitive training device called~     Bilateral Arm Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a~     tele-rehabilitation format will lead to improvement in arm and hand use in patients with~     chronic stroke. The investigators plan to test the effectiveness of home based~     tele-rehabilitation with the BATRAC compared to a clinic based approach.~   "
29953|NCT02665039|"~     This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine~     and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal~     function.~   "
29954|NCT02665026|"~     The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy~     closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and~     safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical~     resection of rectal carcinoma). This study was expected to demonstrate that the early~     preventive ileostomy closure after total mesorectal excision of rectal cancer does not~     increase the risk of complications.~   "
29955|NCT02665013|"~     This trial will assess the effectiveness of a tailored message intervention on decreasing~     infant undervaccination.~   "
29956|NCT02665000|"~     1.1 Aim The investigators wish to validate a structured training program for junior~     residents to enhance their learning curves in performing laparoscopic appendectomy.~      1.2 Hypothesis To introduce a structured laparoscopic appendectomy training program and~     validate its efficacy with the validated GOALS scoring system.~   "
29957|NCT02664987|"~     This study is planned to investigate the pain control status in cancer patients in 6 South~     East Asian countries through evaluation of prescription pattern of analgesics, satisfaction~     of pain control, quality of life and assessment of the adequacy of pain control and~     relationship among these factors in cancer patients with pain. Cancer pain is undermanaged~     and it is hoped that this study will be used as a reference for effective cancer pain~     management in these countries.~   "
29958|NCT02664974|"~     Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized,~     clinical trial.~      The aim of this study is to evaluate the efficacy of home enteral nutrition on the~     nutritional status, the quality of life and tolerance to chemotherapy, in malnourished~     patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach,~     pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition~     (HEN, treatment group) or nutritional counselling (control group).~   "
29959|NCT02664961|"~     The purpose of the study is to determine the overall response rate of single agent TRC105~     and the combination of TRC105 and bevacizumab in patients with refractory GTN (including~     choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic~     tumor (ETT)). Up to 30 patients will be treated.~   "
29960|NCT02664948|"~     The study is a quasi-randomized controlled trial conducted in a Danish University Hospital~     including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up'~     is a multidisciplinary geriatric service provided to older patients who are discharged to~     their home. They receive hospital-visits by a multidisciplinary team no later than 24 hours~     after discharge (except on sundays). The team is consisting of a physician and a nurse both~     with geriatric expertise. The physician is responsible for the clinical patient care. The~     team is available seven days per week/12 hours per day and 24 hour on-call. In the patient's~     home, the team has the possibility to perform diagnosing and treatment by assessments,~     medication review, blood tests, subcutaneous fluid therapy, blood transfusions, intravenous~     antibiotics, rehabilitation and social arrangements. A discharge hand-over supports the~     caregivers and the GP.~   "
29961|NCT02664935|"~     The trial consists of a series of parallel multi-centre single arm phase II trial arms, each~     testing an experimental targeted drug in a population stratified by multiple pre-specified~     actionable target putative biomarkers. The primary objective is to evaluate whether there is~     a signal of activity in each drug-(putative)biomarker cohort separately. A Bayesian adaptive~     design is adopted to achieve this objective and statistical details are given in the~     Protocol.~   "
29962|NCT02664922|"~     The purpose of this study is to compare different combinations of anesthetic drugs (cause~     loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient~     comfort for cardiac electrophysiology procedures. In addition, the investigators are~     studying the different anesthetic combinations to determine the best approach in terms of~     identification and treatment of arrhythmias.~   "
29963|NCT02664909|"~     This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of~     1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of~     transfusion following hip hemiarthroplasty surgery.~   "
30465|NCT02658344|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee~     Osteoarthritis.~   "
29964|NCT02664896|"~     Recently, the medical community has learned damage to the knee joint may be one of many~     possible reasons for pain in knee osteoarthritis. Psychological factors and other aspects of~     brain function seem to play an important role in the pain experience. Although research~     studies have examined these factors on an individual basis, no study has examined all of~     these factors in the same population. Furthermore, some measures of brain function- having~     to do with perception of the painful body part- have yet to be examined in knee~     osteoarthritis. The investigators plan to study many of these variables in a group of people~     with knee osteoarthritis, as well in some healthy controls (without knee pain), in order to~     establish the relative importance of these measures in contributing to pain, as well as~     validate new measures of perception in people with knee osteoarthritis. We also plan to use~     a statistical tool- known as latent profile analysis- to look at subgroups of knee~     osteoarthritis pain. The hypothesis is that different people experience pain in knee~     osteoarthritis for different reasons. This study will be the first study to use all of these~     different variables- which can be reproduced in a clinical setting- to look for different~     subgroups of knee osteoarthritis pain. Ultimately, the goal is to help clinicians better~     prioritize and target interventions to individual patients. The investigators believe this~     will lead to better outcomes and fewer treatment complications currently associates with~     pharmaceutical and surgical interventions that are widely used to treat knee osteoarthritis.~   "
29965|NCT02664883|"~     This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical~     Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from~     patients with kidney cancer in the laboratory may aid doctors in the early detection of~     cancer, monitor tumor response to therapy, detect the presence of occult spreading of~     disease, and identify early return of disease.~   "
29966|NCT02664870|"~     Osteoarthritis is a condition that causes joints in the human body to deteriorate over time.~     This condition affects more than 250 million people around the globe. Currently, the goal of~     treating osteoarthritis involves reducing the severity and pain that results from the~     disease. The ultimate goal of this study is to identify patients with pre-arthritic joints~     (before symptoms or disease characteristics appear) in an effort to find and use treatments~     that stop or slow the disease. Joints are filled with a naturally occurring liquid known as~     synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within~     synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These~     samples have the potential to improve diagnosis, classification, and treatment, possibly~     changing the natural history of this debilitating disease. The purpose of this study is to~     develop a collection of synovial fluid samples from the shoulder, hip and knee for the~     analysis of biomarkers and cellular and genetic components therein to better understand the~     pre-arthritic joint, progression to disease, and response to interventions.~   "
29967|NCT02664857|"~     In this study, effect of vitamin D supplementation on postoperative pain and~     sedation-agitation will investigate. Children with mental motor retardation between 7-17 age~     which dental treatment will be performed under general anaesthesia will be included in this~     study. 600 IU vitamin D will apply to group D per orally during 12 weeks. Group P will not~     take anything during 12 weeks. At first day and end of the 12 weeks, serum vitamin D,~     calcium, alkaline phosphatase, terminal telopeptide C(β-CTX) level will evaluate. At the end~     of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling~     polishing, tooth extraction, filling applications, amputations, root canal treatment. After~     then postoperative pain, sedation and agitation will be evaluate. All data will be~     statistically evaluate at the end of the study.~   "
29968|NCT02664844|"~     In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (>~     70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner~     the same day. The effect on food intake of the distribution of this exercise into two~     sessions during 24h remains to be determined. In addition, a multidisciplinary load of~     obesity generates a loss of body weight in the short term, which we do not know the effects~     on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of~     muscle exercise is unknown.~   "
29969|NCT02664831|"~     This is a prospective, observational study of inflammatory mechanisms and lipid metabolism~     after resuscitation from cardiac arrest during targeted temperature management.~     Investigators are focusing on elucidating two biochemical pathways. The first is~     neuregulin-1 (NRG-1), a growth factor regulating cell resistance to oxidative stress, cell~     survival and proliferation. The second relates to lipid peroxidation and pro-inflammatory~     lipid precursors. Participants will undergo blood sampling during 7 days following cardiac~     arrest, and analyses performed. Patient characteristics, clinical circumstances, and~     outcomes will be recorded and their associations with these inflammatory pathways~     characterized.~   "
29970|NCT02664818|"~     The purpose of this study is to assess clinical characteristics, treatment, and outcome of~     patients hospitalized with heart failure in China and compared those with other registries~   "
29971|NCT02664805|"~     To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249~     ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.~   "
29972|NCT02664792|"~     To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the~     Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for~     staging of non-small cel lung carcinoma.~   "
29973|NCT02664779|"~     Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life~     support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an~     attempt to simplify and optimize, however, it has not compared the effectiveness among the~     three methods with more evidence among professionals with varying degrees of medical~     training (ALS Workshop participants).~      Objective: To determine and compare the effectiveness of the three most widespread and with~     more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a~     short-term and its perceived easiness among ALS workshop participants.~      Methods / design: Educational Cuasi experimental trial with pre and post intervention~     measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three~     systematic methods to recognize arrhythmias will be taught and their effectiveness to~     diagnose in a short-term and its perceived easiness will be measured and compared.~   "
29976|NCT02664740|"~     The primary objective of this study is to compare the efficacy of standard treatment~     associated with a topical anti-staphylococcal bacteriophage cocktail versus standard~     treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or~     susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface~     area (%) at 12 weeks.~   "
29977|NCT02664727|"~     The purpose of this research is to examine the effects of exercise of different intensities~     on psychological, physiological, biochemical, physiological and alcohol-related parameters~     in individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order~     to investigate possible biochemical mechanisms by which exercise may be a healthy~     alternative to alcohol abuse. For that purpose, a control group of individuals that do not~     exceed the limits for moderate alcohol use will be included.~   "
29978|NCT02664714|"~     The aim of this study is to evaluate if the training of pelvic floor muscles, which~     associates an individualized treatment progressing to a group treatment, would be more~     effective than an individualized training only or groups only.~      Methods: Randomized controlled study which will be done from January to December of 2016, on~     Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.~      Inclusion criteria: women with stress UI, older than 18 years old. The sample size~     calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a~     sample of 30 women in each group. The volunteers will be assessed before the intervention by~     a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT~     scheme and perineometry.~      After the evaluation will be performed the randomization of the volunteers by a blinded~     investigator and the volunteers will be allocated into three groups:~      Group 1: Individualized Training Group 2: Individualized training with progression to group~     training Group 3: Group training only~      For all groups it will be used the same protocol that was prepared according to the~     recommendations of the American College of Sports Medicine. Later, volunteers will be~     reassessed after 12 treatments, three months and six months (from the discharge date). It~     will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises~     Practice.~      Primary outcome: severity measures of the King's Health Questionnaire.~      Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for~     Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test~     (SPSS 19.0). The comparison between the evaluations will be performed by ANOVA, and the~     comparison between groups will be performed by Student t-test (independent measures). In~     order to measure the practical significance of the data, the effect size and the confidence~     interval (CI) will be calculated. A 5% significance level will be assumed. This study was~     approved by the Research Ethics Committee of the Federal University of São Carlos, São~     Carlos- SP, Brazil (Protocol 1207393).~   "
29979|NCT02664701|"~     The primary objective of this study is to evaluate the efficacy of a program of 6 sessions~     of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual~     Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months~     post-psychotherapy in adults admitted to inpatient care for suicide attempts.~   "
29980|NCT02664688|"~     The purpose of this study is to compare the effectiveness of pain control and functional~     improvement in patients with degenerative spondylolisthesis treated with lumbar~     stabilization exercises vs flexor exercises (williams exercises)~   "
29981|NCT02664675|"~     Recent data found that peri-implantitis may differ from periodontitis at the histological~     level in terms of extent and composition of the cellular components. From human biopsies, it~     has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger~     proportion of granulocytes and macrophages in peri-implantitis lesions compared to~     periodontitis lesions. Following experimental peri-implantitis, it has been observed a~     continuing bone loss around dental implants after ligature removal; whereas, such a~     progression was not observed around teeth after cessation of the experimental periodontitis.~     The factors influencing the recruitment and the activation of osteoclasts in both diseases~     have not been compared yet.~      Hypothesis : The more rapid and more severe alveolar bone destruction occurring in~     peri-implantitis compared to periodontitis is due at least in part to differences in the~     inflammatory process in these diseases.~      Aim: to study the cytokine profile produced by gingival explants from periodontitis or~     peri-implantitis sites and to test the consequences on alteration of bone remodelling~     activity using in vitro approach.~      Materials and methods The investigators will establish a collection of human gingival~     samples from patients undergoing surgical treatment of periodontitis or peri-implantitis.~     The investigators will test pro-inflammatory cytokines and chemokines release and~     consequences on osteoclast differentiation and activity.~   "
29982|NCT02664662|"~     For the past few years, the survival rate of breast cancer improved due to the advancement~     of surgery techniques and popularization of cancer screening. However, prolonged survival~     rate is definitely not equal to achieving a sound quality of life among breast cancer~     survivors. The health status of cancer survivors might deteriorate according to the severe~     side effect of multiple therapies.~      Health literacy is the ability to access, understand, evaluate and communication information~     as a way to promote and maintain health. Therefore, good health literacy raise the quality~     of life of breast cancer survivors by a good competence in searching and using medical~     resources. Moreover, how to improve health literacy after cancer surgery becomes an~     important part recently. Even if the most fundamental concept has promoted for decades, the~     clinical workers still use the identical education of medical care after surgery for breast~     cancer survivors. However, the identical education is not appropriate for each of patients.~     In fact, each of breast cancer survivors has the different cancer stage leading to accept~     different therapy and producing different side effect. Besides, the background and the role~     of life are very different from each other. Because of the above reasons, the aim of the~     study is going to develop a tailored rehabilitated education, which fit for each breast~     cancer patients after surgery in clinic. At the same time, the health literacy ability might~     be improved by tailored rehabilitated education. When health literacy level is raised, the~     breast cancer survivors have a good quality of life and beautiful health status.~   "
29983|NCT02664649|"~     ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial.~      The objective of this study is to demonstrate superiority of a strategy of anticoagulation~     with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who~     have undergone a successful TAVI procedure.~      The randomization is stratified according to the presence or not of a mandatory indication~     for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or~     DVT/PE).~   "
29984|NCT02664636|"~     The main objective is to develop models for the cortical reorganization of motor areas and~     inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the~     fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to~     correlate the latter with the early phases of motor recovery over the same period, as~     measured by the test Fugl-Meyer.~   "
44782|NCT02470858|"~     The study is designed to test the hypothesis that the addition of a protease inhibitor to~     dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten~     the treatment duration to 3 weeks.~   "
29985|NCT02664623|"~     The main objective of this study is to measure effectiveness at 6 months of personalized~     dietary advice versus dietary counseling via delivery of a standard advice sheet for~     optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS~     patients with ambulatory monitoring.~      *CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency~     for Sanitary Security of Food, Environment and Labour) website, published by the Observatory~     of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional~     components. The data is integrated into the software for calculating ingesta (DATAMEAL) at~     the Nîmes University Hospital.~   "
29986|NCT02664610|"~     One of the most powerful predictors of stroke is hypertension, with estimates of~     approximately 33% of adults in the United States experiencing this condition. Hypertension~     is significantly more prevalent in African Americans compared to European Americans.~     Importantly, hypertension is a modifiable stroke risk factor.~      This proposal will use a community-based participatory research approach to perform a~     randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure~     in an urban African American community in Flint, Michigan.~   "
29987|NCT02664597|"~     Background : About 25% of adnexal masses remain indeterminate after transvaginal~     ultrasonography, as evidenced by the published literature. According to a multicenter study~     conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and~     ultrasonographic appearances and a high rate of benignity is finally found at pathology~     (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal~     masses with an accuracy>95%. However, among physicians, a debate exists on the relevance of~     MR imaging to characterize adnexal masses possibly due to the absence of standardization of~     the MR report. In 2013, the first MR scoring system for adnexal masses named ADNEXMR score~     was developed and found to be accurate, with an AUROC>0.94 to distinguish benign from~     malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the~     radiologist's suspicion of malignancy to clinician has the potential aim of improving~     patient management, in particular by limiting the number of patients undergoing~     inappropriate surgery.~      Main objective: To compare the rate of inappropriate surgery that occurs when patients are~     managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic~     strategy performed in clinical routine.~      Primary endpoint: The rate of inappropriate surgical intervention during the two first~     months after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and~     incomplete staging for borderline or invasive cancer).~      Study design:~        -  The study is a prospective multicenter randomized diagnostic study. 606 patients will~          be included by 7 hospitals (14 centers).~        -  Total duration of the study is 36 months with one year for patient inclusions.~        -  At D0, following informed written consent, patients will be randomized in one of two~          groups (intervention group or control group). In the intervention group, patients will~          undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including~          morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic~          gadolinium injection) and functional sequences (perfusion and diffusion-weighted~          sequences). Prospectively, a senior radiologist analyzes the different MR criteria to~          characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING~          system and the patient will be managed according to the score. In control group, the~          complex adnexal mass will be managed according to the standard strategy and treatment~          plan routinely used by the multidisciplinary team. Clinical, biological,~          ultrasonographic and/or MR data and the type of treatment will be recorded. If a~          surgery is required, surgical procedure will be performed within the two months after~          initial diagnostic imaging (as routinely recommended).~      At M6/M12, follow-up will be performed. If the lesion has increased or changed with~     suspicious criteria, surgery will be performed as routinely recommended in both groups.~      At M24, adnexal masses status will be recorded by clinical and imaging follow up.~   "
29988|NCT02664584|"~     Background:~      Cardiovascular disease (CVD), osteoporosis and dementia are chronic diseases of ageing that~     impact adversely on the lives of those affected and have major health, social and economic~     consequences. A number of factors are considered to be implicated in these diseases, ranging~     from the more established factors to those that are less well recognised. Lifestyle factors~     such as diet, body weight, smoking, physical activity and years of education are~     acknowledged as risk factors for the development of these chronic diseases of aging.~     Emerging research suggests that elevated homocysteine and/or sub-optimal status of the~     metabolically related B-vitamins (folate, vitamin B12, B6 and riboflavin) may be associated~     with a higher risk of age-related disease. The interplay between relevant genetic and~     nutrient factors (gene-nutrient interactions) is considered to be highly relevant in the~     development (and prevention) of chronic diseases of ageing, however this relatively new area~     of research is as yet poorly understood. The collection of clinical, lifestyle, nutritional~     and genetic data on large numbers of patients would permit the investigation of those~     nutrients which interact with specific genes to increase the likelihood of a person~     developing chronic diseases of ageing.~      Aim:~      The aim of the TUDA study is to collect detailed clinical, lifestyle, dietary, genetic and~     biochemical data to investigate gene-nutrient interactions (particularly from the~     perspective of the B-vitamins and vitamin D/calcium) in the development of CVD, osteoporosis~     and dementia by studying older adults exhibiting the early stages of these common diseases,~     namely hypertension, low bone mineral density, and early memory loss, respectively.~      Secondary aim (follow up TUDA investigation):~      The aim of this longitudinal investigation is to re-assess clinical, nutritional, genetic~     and biochemical factors in relation to the progression of disease outcomes in TUDA study~     participants, in subsequent years after initial investigation.~      Study design:~      A total of 6000 non-institutionalised older Irish people aged over 60 years with early~     predictors of either dementia, stroke and osteoporosis (namely early memory loss, high blood~     pressure and low bone mineral density, respectively) recruited from three centres (St~     James's Hospital Dublin, Ulster University Coleraine and The Clinical Translational Research~     and Innovation Centre (C-TRIC), Londonderry) across Ireland. Non-fasting blood samples were~     collected from all subjects and routine blood biochemistry profiles and biomarkers of~     relevance to B vitamin and vitamin D status were measured. Supplement use was recorded and a~     targeted food frequency questionnaire was used to record dietary intakes of specific~     vitamins of interest (folate, B12, B6, riboflavin and D) from major food sources,~     particularly fortified foods. Physiological function tests including blood pressure, bone~     health (DXA scans) and cognitive function tests and anthropometric measures were also taken.~   "
29989|NCT02664571|"~     The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ:~     FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis~     in non-demented patients with that observed in healthy subjects, patients with ACA and with~     lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.~   "
29990|NCT02664558|"~     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH)~     (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical~     worsening. This proof-of-concept study is designed as a Phase 2, multicenter, randomized,~     double-blind, placebo controlled study comparing ubenimex with placebo in patients with PAH~     (WHO Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification~     (WHO/NYHA-FC) of II or III. The Primary Objectives for the study are:~        -  To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).~        -  To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.~   "
29991|NCT02664545|"~     The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate~     Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate~     ligament (ACL) injuries, ACL reconstruction.~   "
29992|NCT02664532|"~     The purpose of this prospective open labeled randomized study was to compare the~     laryngoscopic glottis view as well as ease of intubation between the two blades in~     routine intubations in non-difficult airways.~   "
29993|NCT02664519|"~     Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance.~     Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle~     blood flow regulation has not been fully explored. The investigators hypothesize that~     functional sympatholysis is exaggerated in CKD and this is associated with increased~     oxidative stress. The investigators also hypothesize that exercise training will improve~     functional sympatholysis and oxidative stress~   "
29994|NCT02664506|"~     The aim of this research is to translate a theory of the cognitive relationship between~     verbal short--term memory (STM) and word processing impairments in aphasia to treatment~     approaches for language impairment in aphasia. It has been proposed that the co-occurrence~     of these impairments is due to a disruption of cognitive processes that support both~     abilities: maintenance of activated semantic and phonological representations of words,~     hereafter the 'activation--maintenance hypothesis'.~      This hypothesis will be tested in the context of a treatment approach that aims to improve~     word processing and verbal STM abilities.~   "
30022|NCT02664142|"~     General anaesthesia (GA) is, according to many definitions, the greatest gift presented to~     the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of~     anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it~     is necessary to observe the clinical condition of the patient, and at the same time monitor~     the patient's overall condition. With the currently available options of GA management (e.g.~     use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in~     combination with various methods of topical anaesthesia) the importance of methods measuring~     the depth of GA increases. The depth of GA may be defined as a continuous progressive~     decreasing of the central nervous system, together with a decreased reactivity to stimuli.~     In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening~     during a surgical procedure may result in significant psychological complications (e.g.~     post-traumatic stress disorder), and the patient may suffer from a serious long-time~     disorder.~   "
29995|NCT02664493|"~     -  Several studies have shown that about 30% of transplanted kidneys with stable function~          present with tubule-interstitial mononuclear cell infiltration in protocol biopsies and~          therefore meet criteria for acute rejection. This subclinical rejection (SCR) has also~          been correlated with subsequent chronic allograft nephropathy and allograft~          dysfunction.~        -  The Banff scheme defines the minimal threshold for acute T-cell mediated rejection as~          infiltration of 25% or more of the renal cortex with five or more mononuclear cells in~          a focus of tubulitis or intimal arteritis (histological indices i2t2 or v1) and refers~          to borderline changes as those with insufficient for a diagnosis of acute T-cell~          mediated rejection, including mild to moderate (<50%) cortical infiltration and one to~          four mononuclear cells per tubule in cross section (i1t1 or i2t1)~        -  No consensus for the treating patients with borderline changes has been reached.~          Borderline changes with graft dysfunction are occasionally routinely treated with~          steroid pulse and, whereas subclinical borderline changes are simply 'ignored'.~          Particularly, a previous study demonstrated that most cases designated borderline by~          histopathology are found to be non-rejection by molecular phenotyping~        -  The aim of this study is to investigate the effect of early steroid pulse therapy for~          the reduction of acute rejection episode during the first year after renal~          transplantation in the patients who will show subclinical borderline changes at 2-week~          protocol biopsy.~   "
29996|NCT02664480|"~     Investigators aimed to investigate whether there is an association between ovulation and~     salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group~     of reproductive women.~   "
29997|NCT02664467|"~     In a 3 years longitudinal, observational, multicentre study, about 500 women will be~     recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months~     after delivery. The primary aim of the present study is to systematically explore and~     characterize risk factors for perinatal depression (PND) by prospective sleep assessment~     (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based~     analysis of potential markers during the perinatal period (Life-ON study). Secondary aims~     are to explore the relationship between specific genetic polymorphisms and PND (substudy~     Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and~     to test whether a short term trial of BLT during pregnancy can prevent PND (substudy~     Life-ON3).~      The characterization of specific predictive and risk factors for PND may substantially~     contribute to improve preventive medical and social strategies for the affected women. The~     study results are expected to promote a better understanding of the relationship between~     sleep disorders and the development of PND and to confirm, in a large sample of women, the~     safety and efficacy of BLT both in prevention and treatment of PND.~   "
29998|NCT02664454|"~     Older patients account for around 10% of the population, of which 57% have a long-term~     illness, and 33% were admitted in the past year.~      Geriatric assessment (GA) is a multidimensional assessment of general health status that can~     help identifying deficiencies and followed by a personalized care plan.~      Assessment and management of elderly patients is a daily concern for the general~     practitioner (GP) but conflicting results have been reported so far relating to the clinical~     impact of GA when applied in the primary care setting.~      This study protocol aims to assess the effect on morbi-mortality of a complex intervention~     in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate~     that a GA adapted to primary care, followed by a personalized care plan and combined with~     successful interprofessional collaboration can improve clinically relevant outcomes in~     elderly patients with chronic conditions such as one-year overall mortality, unplanned~     hospital admission, emergency visits, or institutionalization.~      The CEPIA study will also help addressing the issue of whether an improved benefit could be~     achieved from a systematic nurse-led or a case-by-case GP-led GA.~   "
29999|NCT02664441|"~     The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist~     exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic~     parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week~     open label extension. Following baseline testing, 48 patients will be randomly assigned with~     equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week~     open label extension during which all patients receive ExQW. Changes of weight status, body~     composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW),~     activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose~     tolerance and hormonal parameters of energy homeostasis and insulin resistance will be~     assessed before treatment and at the end of the placebo-controlled phase (week 36).~     Activity, metabolic outcomes, energy intake will be also assessed at study week 18 (mid~     treatment of randomized study), as well as week 54 (end of open label treatment).~   "
30000|NCT02664428|"~     Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and~     chestnut flour as in PreBIOil product combination can modify the gut microbiota and the~     cholesterol metabolism.~      Primary objectives of the study are to assess whether the test product to be able to change:~        1. fecal microbiota profile;~        2. Plasma cholesterol LDL, total, total LDL and HDL ratio;~        3. plasma triglycerides;~        4. Apolipoprotein ApoA-I, ApoB, and Lp.~      Secondary objectives of the study are:~        1. anthropometric indices;~        2. secondary metabolites of polyphenols in human biofluids;~        3. mass spectrometry plasma and urine metabolite profile;~        4. blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC);~      7) urinary isoprostane F2; 8) oxidized LDL in plasma.~      Study Design: placebo-controlled, randomized, double-blind parallel trial.~      Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m^2. Total Cholesterol 180-240 mg/dl~      Exclusion criteria: Fasting blood glucose >150 mg/dl; triglycerides >500 mg/dl; uncontrolled~     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long~     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic~     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy,~     tobacco smoking.~      Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years,~     will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and~     blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura~     Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the~     participants will be randomized to receive supplementation with either PreBIOil biscuit~     (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing,~     and stool and urine collection will be performed during visits at the beginning and end of~     each treatment period (T0 and T1). A 4 day-food diary record will be collected before visits~     T0, at the beginning of T0 and before T1.~      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food~     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL~     cholesterol, oxidized LDL, serum glucose and insulin, C-RP, Apolipoproteins, Isoprostane;~     urinary and plasma metabolite profiling; fecal microbiota analysis.~      Safety assessments. Adverse events registration.~      Statistical analyses. The differences between the two group will be evaluated with~     univariate and multivariate statistical methods. The medium before and after the~     intervention will be compared with the General Linear Model (ANOVA) for repeated measures or~     for paired data. Simple and multiple linear regressions will be performed to determine the~     relationships between independent variables; also we will run the t-test to evaluate~     differences in compliance detected in the types of supplementation. The results are~     expressed as mean +/- SEM and the differences will be considered significant when P <0.05.~      Duration: Subjects will make three visits (visit T-1, beginning visit T0, and end of~     treatment period visit T1, week 8 from T0). The treatment duration is 8 weeks; a daily~     portion of about 90 g of biscuit is introduced.~   "
30001|NCT02664415|"~     The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody~     (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption~     (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.~   "
30023|NCT02664129|"~     The deficit of awareness of pathology (or insight) is a common symptom in patients with~     schizophrenia and has a negative impact on the prognosis of the disease. Current treatments~     aren't effective enough on this symptom (Pijnenbord et al., 2013).~      Previous studies have shown a positive impact of videos of patients themselves on insight~     but they lacked power (Davidoff et al., 1998 ; Vikram et al., 2008 ; David et al., 2012).~     This technique needs more investigation. Our study aims to improve the patient's awareness~     of pathology with a video of themselves recorded in the acute phase of their illness.~     Patients will watch this video after clinical stabilization. This is a randomized controlled~     and single blinded trial. A population of 60 patients (30 in each group) will be included.~     The impact on the insight, symptomatology, treatment adherence and functional remission will~     be evaluated.~      The video of patient is useful for a personalized clinical follow-up. Its use for~     therapeutic purposes would be innovative and could be extended to other applications in~     psychiatry, especially as this tool is readily available.~   "
30024|NCT02664116|"~     This research will be conducted to see if the oral drug Cambia is as effective in relieving~     severe migraine headaches as the injectable drug ketorolac.~   "
44783|NCT02470845|"~     The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment~     of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.~   "
30002|NCT02664402|"~     Background:~      People undergo many changes when they have a life-threatening illness. Their values may~     change. They may have less fear of illness and death. They may become more spiritual.~     Researchers made a questionnaire called HEALS (Healing Experience During All Life~     Stressors). They want to use it to better understand these positive changes. They hope to~     provide better care for people with serious illnesses.~      Objectives:~      To develop the HEALS tool to better understand psycho-social-spiritual healing in people~     with serious illnesses. Also, to find out how palliative care services help people handle~     their illness or stress.~      Eligibility:~      Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening~     illness. They must be getting:~      Inpatient or outpatient palliative care at NIH Clinical Center OR~      Inpatient palliative care at Suburban Hospital OR~      NIH outpatient palliative care provided at Mobile Medical Care Clinic~      Design:~      Participants will be screened with questions to make sure they are eligible.~      Participants will have 1 individual research session. This will be at the NIH Clinical~     Center.~      Participants will be interviewed by a research team member. They will be asked about changes~     in a person s way of living that might happen during or after a serious illness.~      Participants will be asked for their thoughts and opinions about the questions. They will be~     asked what ideas they may have to make the questions better.~      Interviews will be audiotaped.~      Participants will be asked some questions specific to their care location and team. These~     are to better understand how their services are helping participants.~   "
30003|NCT02664389|"~     Despite relevant clinical and/or familial presentations suggesting a hereditary~     predisposition (early-onset, multiple primary tumors, familial aggregation), targeted~     genomic analysis based on the phenotype are often non contributive. As somatic cancer genes~     are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes,~     selected for their implications in cancers may contribute to the understanding of many~     selected patients' presentation by the identification of germline deleterious mutations, and~     may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset~     breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.~   "
30004|NCT02664376|"~     The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital~     ward.~      Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle~     quality. It is a geriatric syndrome that, to this date, is not systematically tracked in~     clinical practice.~      In order to detect sarcopenia, the investigators will use the operational definition~     proposed by the European Working Group (EWGSOP) involving the measure of three parameters,~     namely the speed of walking, the muscle strength and the measurement of the muscular mass.~   "
30005|NCT02664363|"~     Newly diagnosed glioblastoma subjects who are eligible will be enrolled following surgery to~     remove the brain tumor. They will then undergo a leukapheresis to harvest cells for the~     generation of the study drug, Epidermal Growth Factor variant III Chimeric Antigen Receptor~     (EGFRvIII CAR) T cells prior to beginning standard of care (SOC) radiation therapy (RT) with~     temozolomide (TMZ). Once SOC RT with TMZ is completed, subjects will return for the post-RT~     brain imaging assessment, and if stable will start post-RT TMZ cycles. During the 3rd cycle~     of post-RT TMZ, the EGFRvIII CAR T cells will be infused in dose escalation cohorts.~     Following a one month delay between cycles, the subject will resume post-RT cycles of TMZ~     and be monitored with blood work and brain imaging as per SOC. Once the maximally tolerated~     dose (MTD) is reached in the dose escalation cohorts, an expanded cohort of 12 subjects will~     be enrolled to obtain a more precise estimate of the probability of unacceptable toxicity~     and to track the EGFRvIII CAR T cells using 111 Indium (111In) labeling. Computed Tomography~     (CT) will be done on days 1, 5, and 10 post-infusion to determine intracerebral (IC)~     localization.~   "
30006|NCT02664350|"~     Pain is one of the most burdensome symptoms associated with cancer and its treatment, and~     opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual~     patient responses to opioids vary widely, and the patient's genotype contributes to this~     variability. Specifically, cytochrome P450 2D6 (CYP2D6) genotype has important relevance for~     response to opioid analgesics that depend on CYP2D6 for bioactivation. Poor metabolizers~     (PMs) have lower concentrations of active metabolites of codeine (morphine), tramadol~     (O-desmethyltramadol), oxycodone (oxymorphone), and hydrocodone (hydromorphone), compared to~     extensive metabolizers (EMs). Morphine and O-desmethyltramadol have 200-fold greater~     affinity for the µ-opioid receptor than the parent compound, whereas oxymorphone and~     hydromorphone have 40-fold and 10-fold higher receptor affinity compared to their parent~     compounds, respectively. Consequently, PMs may fail to derive pain relief from these opioids~     compared to EMs. Interestingly, the occurrence of side effects may not differ between PMs~     and EMs so that while PMs may get little to no pain relief from certain opioid analgesics,~     they may still experience troublesome adverse effects. Intermediate metabolizers (IMs) are~     also expected to have reduced analgesic response based on their significant reduction in~     enzyme activity. Conversely, individuals with the UM phenotype may have toxic concentrations~     of active opioid metabolites, with reports of life-threatening toxicity and death. The~     µ-opioid receptor gene (OPRM1) is the primary binding site for endogenous opioid peptides~     and opioid analgesics, and may have additional contributions to opioid response. The~     investigators propose to examine the effect of CYP2D6 genotype-guided pain management on~     cancer pain control in study participants and the additional effect of the OPRM1 genotype on~     response to opioids.~   "
30007|NCT02664337|"~     This study is an observational study to test and validate a questionnaire and statistical~     model used to determine patient preferences regarding treatment for any one of 11~     musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and~     femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture,~     patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia,~     and proximal humerus. This study aims to understand how multiple treatment variables,~     including pain, rehabilitation time, cost, and choice of surgical versus non-surgical~     intervention, impact patients' decision-making processes and ultimate choice of treatment.~   "
30008|NCT02664324|"~     The primary objective of this feasibility study is to evaluate the functionality (e.g., as~     defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance~     Test (MSPT) device, when used by unsupervised participants with MS, or related conditions,~     with a broad range of disability, in multi-clinical-care environments. Secondary objectives~     include: Participant perception of usability of device; Participant satisfaction with the~     device; Ascertain the impact of different clinical environments on device usability;~     Ascertain impact of assistive devices in usability of device; Ascertain functionality of~     Bluetooth remote as compared with manual timing.~   "
30009|NCT02664311|"~     This is a randomized prospective study comparing outcomes of pulmonary vein isolation using~     conventional and jet ventilation.~   "
30466|NCT02658331|"~     The aim of our study is to assess the analytical and clinical performance of the FilmArray~     (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in~     Guinea versus conventional molecular techniques.~   "
30010|NCT02664298|"~     Edentulism is often associated with a negative psychosocial impact. The concept of~     prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants,~     was first introduced in the late 1960s by Brånemark et al. and offers an interesting~     alternative to removable prosthesis. However, for patients with a severely atrophic maxilla~     or mandible, cranial bone grafting of the jaw is required to increase bone width and height~     necessary for implant insertion. An active collaboration between the surgeons from the Oral~     and Maxillofacial Department and the prosthodontist from the Department of Dentistry has~     been established for continuous quality improvement of the concept of (immediate/delayed)~     implant loading in patients requiring cranial bone grafts to augment their severely atrophic~     jawbone.~      The investigators aim to develop a prospective database registering (immediate/delayed)~     implant loading data of all patients eligible according to the protocol. Patient~     demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected~     during consecutive visits within the framework of routine practice.~      Development of a database registering immediate functional loading data secondary to cranial~     bone-grafting of a severely atrophic jaw, will provide more information about potential~     patient, surgical and prosthetic factors influencing long-term biological and mechanical~     stability, as well as patient satisfaction. Moreover, registration of those results could~     function as a measurement of quality of care, and could be used for sample size calculation~     for future large prospective trials.~   "
30011|NCT02664285|"~     The aim of this study is to determine the surgical site infection rate and the patient's~     satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue~     after cesarean delivery in women with diabetes mellitus.~   "
30012|NCT02664272|"~     Multicenter, observational study to evaluate if there is a difference between the final~     position of the femoral stem and the last trial rasp when using the SL-PLUS™ MIA Ti/HA~     femoral hip stem with the appropriate set of instruments.~   "
30013|NCT02664259|"~     The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin~     bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial~     ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without~     radiographic fluoroscopy.~   "
30014|NCT02664246|"~     This review article have included about ten thousand patients undergoing percutaneous~     coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new~     risk factors and the protecting methods for these factors.~   "
30015|NCT02664233|"~     In order to facilitate the evidence-based goal setting and self-monitoring intervention into~     the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an~     electronic system provided available to the American Diabetes Association diabetes education~     programs, to set patient diet and physical activity goals, and connect patient~     self-monitoring information collected from smart phones and fitness trackers to Chronicle~     Diabetes system to facilitate educators' monitoring of patient adherence to their goals.~   "
30016|NCT02664220|"~     The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for~     decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.~     Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal~     irrigation.~   "
30017|NCT02664207|"~     The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to~     mothers with a BMI of 35-40 kg/m2 (extending the Management of Myelomeningocele Study (MOMs)~     criteria for BMI) and to evaluate the efficacy and safety of this extension, by capturing~     clinical and outcome information.~   "
30018|NCT02664194|"~     To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to~     percutaneous coronary intervention in patients with acute myocardial infarction.~   "
30019|NCT02664181|"~     The purpose of this study is to assess whether treatment with the study drug~     tetrahydrouridine-decitabine (THU-Dec) in combination with nivolumab is more effective than~     treatment with nivolumab alone in patients with NSCLC.~      Decitabine is an investigational (experimental) drug that works by depleting DNA~     methyltransferase 1 (DNMT1). DNMT1 is an enzyme, or protein that causes chemical changes,~     often increased in cancer. Blocking DNMT1 has been shown to reduce tumor formation.~     Decitabine is experimental in this study because it is not approved by the Food and Drug~     Administration (FDA) for patients with lung cancer. Decitabine is approved by the FDA for~     treating patients with a blood disease called myelodysplastic syndrome (MDS, a condition~     where the bone marrow does not make blood cells normally).~      THU is an investigational (experimental) drug that works by blocking an enzyme that breaks~     down decitabine. This enzyme is highly expressed in solid tissues of the body, limiting the~     distribution of decitabine into these tissues, including solid cancer tissues. So, THU will~     increase the time cells in your body are exposed to decitabine. The idea is that THU will~     also increase the time that the lung cancer cells are exposed to decitabine. THU is~     experimental because it is also not approved by the FDA, although it has been extensively~     used in clinical trials, including several cancer trials.~   "
30020|NCT02664168|"~     The aim of this study is to assess the prevention of incision healing complications in~     patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared~     to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a~     revision TKA and THA who consent to taking part in the study, and meet the eligibility~     criteria will be included onto the study. Patients will be followed up for a period of up to~     3 months to determine if there are any latent incision healing complications~   "
30021|NCT02664155|"~     In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC)~     anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is~     associated with an increased risk of thromboembolic and bleeding complications compared to~     patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be~     at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate~     renally impaired patients were poorly represented and patients with severe renal~     insufficiency not at all. So no dose reduction was considered.~      Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally~     impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in~     patients with moderate and severe renal insufficiency.~      We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE~     patients with moderate or severe renal insufficiency in terms of net clinical benefit~     (recurrent VTE and major bleeding) at 3 months.~   "
30025|NCT02664103|"~     Primary Objectives:~        -  To assess the safety for each cohort of patients on a fixed-dose combination pill of~          capecitabine and cyclophosphamide administered at flat dose and with metronomic~          schedule (defined as continuous daily treatment without interruption) in patients with~          metastatic breast cancer.~        -  To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination~          pill of capecitabine and cyclophosphamide administered at different doses/regimens by~          metronomic schedule in patients with metastatic breast cancer.~      Secondary Objectives:~        -  To assess antitumor activity of the fixed-dose combination pill of capecitabine and~          cyclophosphamide administered at different doses/regimens by metronomic schedule in~          patients with metastatic breast cancer given at 3 different doses and schedules~          (regimen 1=standard dose twice daily [BID], regimen 2=full dose once daily [OD],~          regimen 3=low dose [OD])~        -  Disease Control Rate (DCR)~        -  Overall Response Rate (ORR)~        -  Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors~          (RECIST) criteria (version 1.1).~        -  To evaluate the compliance under treatment.~        -  To describe evolution of toxicities.~        -  To assess safety all along patient's treatment.~   "
30026|NCT02664090|"~     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in ICU. This~     syndrome is associated with high morbidity and mortality. In management of ARDS patients,~     lung protective ventilation and prone ventilation are key strategies which have shown~     survival benefits in recent years. Prone positioning has been reported to have hemodynamic~     disturbances like hypotension and arrhythmias. The literature till date is unclear with~     regards to acute hemodynamic changes which can happen during initiation of prone ventilation~     ,with a few studies suggesting decreasing cardiac output and a few increasing cardiac~     output. In recent years, trans-esophageal Doppler (TED) has become one of important~     hemodynamic assessment tool due to its minimal invasiveness, ease of use with its clinical~     utility established by various studies both in operation theatres and intensive care units.~     In current study, the investigators would like to evaluate acute hemodynamic effects of~     prone ventilation with TED in patients of acute respiratory distress syndrome (ARDS).~   "
30027|NCT02664077|"~     This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical~     trial. The primary aim of this study is to determine the value of regorafenib in improving~     disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined~     by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual~     are randomized 1:1 to placebo or the experimental agent regorafenib following completion of~     at least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin,~     oxaliplatin (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).~   "
30028|NCT02664064|"~     The goal of this study is to evaluate an online Diabetes Prevention Program adapted for~     patients with prediabetes in safety net health care settings.~   "
30029|NCT02664051|"~     This is a randomized, double-blind, cross-over study in healthy volunteers. In the first~     part, the duodenum of the participants will be perfused with acid or saline, during which~     intragastric pressure will be monitored to assess activation of the duodenogastric reflex.~     After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the~     second part, healthy volunteers are treated with the mast cell stabilizer disodium~     cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused~     with acid and intragastric pressure and mucosal integrity will be evaluated.~   "
30030|NCT02664038|"~     Alcohol Use Disorders (AUDs) have a significant public health impact and are highly~     prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory~     and executive function) reduce ability to benefit from current treatments. These cognitive~     impairments are especially common in the early phase of recovery, persist over years and get~     worse with age. Recent research suggests that cognitive remediation therapy (CRT) may~     improve attention, memory and executive function in other disorders, and the investigators~     just completed pilot study with AUD Veterans found significantly greater improvements for~     those receiving CRT. The proposed study examines AUD outcomes and neurocognitive~     improvements when CRT is combined with a standardized alcohol treatment. The investigators~     hypothesize that CRT will improve neurocognition and AUD outcomes more than standardized~     alcohol treatment alone. Findings will determine whether CRT augmentation can benefit~     Veterans with AUDs.~   "
30031|NCT02664025|"~     Teaching technical skills during medical training can lead to some issues, which can concern~     ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific~     because it concerns the genital area and it interferes with obstetrical management.~   "
30032|NCT02664012|"~     The purpose of this study is to measure plasma nicotine uptake parameters, physiological~     measures, and subjective effect measures in smokers during and following a single ad libitum~     use of three menthol electronic cigarettes versus combustible menthol cigarettes and~     nicotine gum.~   "
30033|NCT02663999|"~     This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK)~     study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray~     using two dose levels~   "
30034|NCT02663986|"~     The primary aim of this project is to address the need for an effective school-based~     intervention for elementary school-aged students with Organization, Time Management, and~     Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that~     it can be implemented in school settings. Investigators are learning to adapt an individual,~     clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive~     Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To~     this end, investigators will be collecting data on implementation (such as feasibility and~     acceptability), program development (what changes to the individual OST-C program were made~     based on findings during this study) and limited outcome data (repeated measures collection~     and pre- and post-treatment collection on a small sample, no control group).~   "
30035|NCT02663973|"~     The principal goal of this study is to describe the epidemiology of breast cancer in the~     Brazilian population~   "
30328|NCT02660138|"~     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of~     two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in~     reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor~     overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).~   "
30036|NCT02663960|"~     Anticoagulation is required to prevent clotting in the extracorporeal circuit during~     continuous renal replacement therapy (CRRT). Regional citrate anticoagulation has many~     advantages regarding bleeding risk and filter survival. However, in clinical practice, its~     use worldwide has been limited by cumbersome protocols . In order to establish a simple~     scheme for universal application. In Aug 2015, the investigators have adopted a new protocol~     using a fixed citrate concentration in the filter of about 4 mmol/L (called fixed group for~     short) instead of conventional adjusted citrate doses according to postfilter ionized~     calcium levels of less than 0.4mmol/l (adjusted group), and speculated the abilities on~     efficacy and safety as well as convenience.~   "
30037|NCT02663947|"~     Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption~     leading to intracranial hypertension. Assessment of the change in intracranial pressure~     after ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative~     management. The optic nerve sheath diameter measured using ultrasonography has been verified~     as a non-invasive indicator of intracranial hypertension in various clinical studies. The~     investigators hypothesized that a change in optic nerve sheath diameter detected through~     ultrasonography could help ascertain a reduction in intracranial pressure following~     ventriculoperitoneal shunt surgery in adult patients without the risk of serious~     complications.~   "
30038|NCT02663934|"~     Management and treatment of older persons living with HIV (PLWH) (≥ 50 years old) is~     becoming increasingly more complex as a majority is greater than 50 years old. This proposal~     will conduct a prospective controlled intervention trial to assess the quantitative and~     qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a~     social-interaction stretching (SIS) program on brain health (neuropsychological performance~     testing and neuroimaging measurements) in older PLWH. These results could influence public~     health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate~     the development of effective EXS programs for older PLWH.~   "
30039|NCT02663921|"~     The purpose of this study is to learn more about the potential effects of visible light on~     the skin. More specifically, this study will examine whether an incandescent lamp (light~     bulb) or LED light bulb can cause skin to become darker. Investigators will determine the~     minimum threshold dose required to achieve immediate pigmentation darkening (IPD),~     persistent pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types~     IV - VI utilizing two visible light sources.~   "
30040|NCT02663908|"~     The purpose of this trial is to test if a marketed drug for advanced prostate cancer~     (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another~     marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer~     and cardiovascular disease.~   "
30041|NCT02663895|"~     This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis~     (SSc) and at least one calcinotic lesion of the hands that is palpable on physical~     examination and also measureable on hand radiographs, at one single center. Each subject~     will receive treprostinil orally for 12 months, and follow-up evaluations will be performed~     every 3 months. Our main objective is to determine whether oral treprostinil is safe, and~     effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a~     result of microvascular injury and ischemic damage, and that therefore treprostinil may be~     beneficial in the treatment of calcinosis in patients with SSc.~   "
30042|NCT02663882|"~     The purpose of this study is to learn more about self-control and adults who smoke~     cigarettes. It has been suggested that people can improve self-control by practicing tasks~     that require the use of self-control (such as delaying cigarettes or sitting up as straight~     as possible). The goal of this study is to learn about whether scores on self-control and~     other measures will change after one week of practicing self-control tasks at home. We~     believe that adults who smoke cigarettes will show better self-control after practicing~     tasks for a week.~   "
30043|NCT02663869|"~     Clinical hypotheses:~      The increasing number of people aging with HIV is a matter of fact. Differences in~     prevalence of comorbidities between the general population and HIV-positive patients are~     mainly driven by duration of HIV infection rather than chronological age of HIV+ patients.~      People aging with HIV display heterogeneous health conditions. Host factors and duration of~     HIV infection are associated with increased risk of MM, independently from chronological age~     and these factors are responsible of the prevalence difference of comorbidities and MM in~     comparison to the general population.~      Objectives:~      The study objective is to assess the prevalence of, and risk factors for, individual~     co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration~     of HIV infection, but 30 years difference. We compared estimates across both groups to a~     matched community-based cohort sampled from the general population.~   "
30044|NCT02663856|"~     Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian~     team members to begin to build a frailty index (FI) including 37 health variables at the~     Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently~     published, and more data comparing FI in HIV infected vs un-infected people, have been~     presented at international meeting and are at present submitted for publication.~      The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin~     preliminary work in consideration of the similar multidisciplinary approach in Ageing care~     and capacity to address health status in ageing HIV patients using shared definitions of~     co-morbidities, multi-morbidity and measures of Physical Function and Cognition impairment,~     disability and quality of life. The investigators wanted to overcome the major criticism~     intrinsic in the FI, that is the needs to collects many variables not easily available in~     most HIV centres. The the investigators approach is to make patient living with HIV (PLWH),~     be the source of health variables taking advantage of information and communication~     technologies available with smart phones and fitness tracking device, collecting~     physiological parameters and patient related outcomes.~   "
30165|NCT02662270|"~     Fibromyalgia is a relatively young condition recently recognized by the WHO as a separated~     clinical entity. Part of the medical comunity thinks of it as a mixed condition between~     depresion and rheumatic pain, however, functional data provided by sophisticated imaging~     techniques points at a diminished brain activity in several brain regions. The present study~     aims to characterize those findings by means of QEEG in order to establish the~     electroencephalographic characteristics of fibromyalgia patients.~   "
30045|NCT02663843|"~     Tracheal intubation under general anaesthesia is the gold standard for securing the airway~     and for protecting the lungs against gastric aspiration. The conventional technique involves~     the use of a metal laryngoscope inserted into the mouth to create an air space, to allow~     insertion of an endotracheal tube.~      Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for~     tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of~     the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto~     the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is~     called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our~     study compares the performance of two SGD: i-gel and air-Q. The investigators will compare~     intubation success rate, insertion rate, and times for SGD insertion and intubation.~   "
30046|NCT02663830|"~     The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate~     in women undergoing induction of ovulation using clomiphene citrate.~   "
30047|NCT02663817|"~     The hypotheses of the study are as follows:~        -  Mass-based inverse optimization in radiotherapy treatment planning will result in a~          reduction of normal tissue and organs at risk (OAR) doses for desired prescription~          therapeutic doses to the targets.~        -  Dose-mass histograms (DMHs) may be more relevant to radiotherapy treatment planning and~          treatment plan assessment than the standard of care, realized through dose-volume~          histograms (DVHs)~   "
30048|NCT02662764|"~     Patients who meet all inclusion and exclusion criteria at screening and following surgery~     will receive the Zalviso System™ and evaluate its usability and functionality for up to 72~     hours.~   "
30049|NCT02662751|"~     The main objective of this study is to compare two post-stroke/TIA (transient ischemic~     attack) imaging strategies in terms of the number of clinically important (i.e. requiring~     specific treatment according to current recommendations) lesions detected. The first~     strategy is the current/usual strategy in each participating centre and the second strategy~     consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose~     angiography and subsequently resorting to elements of the usual strategy if required.~   "
30050|NCT02662738|"~     This study is to quantify the effect of a natural fruit extract added to a wheat product on~     the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE~     * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)~   "
30051|NCT02662725|"~     This is a non-controlled, open label, Phase II Study of ipilimumab combined with a~     Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of~     Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3~     days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10~     mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity~     or withdrawal of consent or disease progression. The primary objective is the overall~     survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute~     lymphocyte count (ALC) as a predictive biomarker.~   "
30052|NCT02662712|"~     The purpose of this study is to evaluate pharmacokinetics and safety data including serious~     and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms~     (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).~   "
30053|NCT02662699|"~     Anemia is a common pathology in geriatrics. According to the World Health Organization it~     affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in~     Europe. A prevalence that increases with the age and twice in individuals over 85 years.~   "
30054|NCT02662686|"~     The number of copies of mitochondrial genes (mtDNA or MitoScore) is related to the energy~     supply of the embryo, which can affect its ability to implant in the maternal uterus.~      The objective of this study is to analyse the potential of MitoScore before embryo transfer~     as a marker to identify and select the embryo with greater capacity of implantation. First~     of all, chromosomally normal embryos will be selected and mtDNA copies will be quantified.~     Finally, embryos with less copies of mtDNA will be considered for embryo transfer.~   "
30055|NCT02662673|"~     Focal treatment of localized prostate cancer aims to destroy the cancerous foci without~     damaging surrounding tissues to avoid the side effects of radical treatments. This is why~     focal treatment is positioned as an alternative to radical surgery as well as an alternative~     to active surveillance.~      This study is a feasibility study. It aims at treating the index tumor (the most aggressive~     one) which determines the vital prognosis of patient, while preserving the maximum~     surrounding prostatic tissue to preserve quality of life. The expected result is the total~     destruction of aggressive tumor areas by focal or multifocal treatment strategy using the~     Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by~     the negative biopsy rate between 6 and 12 months post-treatment.~   "
30056|NCT02662660|"~     A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy~     between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia~     iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites~     infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic~     Scale and morphine rescue needs were determined 24 hours after surgery.~   "
30057|NCT02662647|"~     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the~     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory~     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more~     sensitive to the following adoptive T cell therapy.We proposed a hypothesis that~     decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in~     eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.~   "
30058|NCT02662634|"~     Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in~     patients with resectable non-small cell lung cancer.~   "
30182|NCT02662036|"~     This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine~     (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in~     terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12,~     24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of~     stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead~     to greater patient satisfaction.~   "
30059|NCT02663791|"~     Arterial stiffness is an important marker of cardiovascular health. Recent evidence from~     cross-sectional research has suggested it is associated with alcohol consumption. Research~     that employs a longitudinal perspective may be better equipped to evaluate the nature of~     this relationship and in particular to determine whether alcohol consumption is linked to~     the progression of arterial stiffness over time. The current study will consequently~     implement a longitudinal cohort design to evaluate the association between long-term alcohol~     consumption patterns and changes in arterial stiffness. Data will be drawn from the~     Whitehall II cohort study of British civil servants, in which participants completed repeat~     pulse wave velocity (PWV) assessments of arterial stiffness across a four-to-five year~     interval. Repeat measurements of volume of alcohol intake were also recorded for~     participants, extending back across more than two decades. Intake will be categorised in~     such a way as to distinguish between different alcohol consumer types, including~     non-drinkers and former drinkers. Linear mixed effects models will be used with adjustment~     for potential confounds, such as age, diabetes, mean arterial pressure and heart rate.~     Results from the modelling work will illustrate the extent and form of the association~     between alcohol intake and PWV. This work will provide useful insights into the role that~     alcohol intake plays in the longitudinal progression of an important cardiac marker, and it~     will have implications for our understanding of alcohol's relationship to cardiovascular~     health in the general population.~   "
30060|NCT02663778|"~     This randomized clinical trial targets 248 community-dwelling older adults with impaired~     mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week~     standard-plus program of strength, endurance, flexibility plus task specific timing and~     coordination training to a standard 12 week strength, endurance and flexibility program. The~     primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent~     components of the intervention and measures of activity and participation. Delayed and~     sustained effects of the intervention are examined at 24 and 36 weeks.~   "
30061|NCT02663765|"~     Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality~     rate because adequate utilization of antenatal health care services is associated with~     improved maternal and neonatal health outcomes. The trend of maternal mortality in~     developing countries has been increasing and various international organizations have~     reported that an important factor related to maternal and infant mortality has been linked~     to lack of antenatal care. According to Federal Ministry of Health, some of the dangers of~     pregnancy and childbirth can be avoided if the pregnant woman attends antenatal regularly.~     In order to decrease these mortality rates, regular antenatal care has to be instituted or~     reinforced which can only be achieved through identifying factors causing poor utilization~     of antenatal care services~   "
30062|NCT02663752|"~     Several previous studies (clinical and non-clinical) hypothesize that treatment with~     deferasirox causes a hematological improvement in transfused patients with low and~     intermediate-1 risk myelodysplastic syndrome. The purpose of this study is to assess the~     presence of genetic biomarkers predictive for hematologic response by the use of gene~     expression profiling of bone marrow aspirates obtained from MDS patients with or without~     hematological response.~   "
30063|NCT02663739|"~     The study is a post-market surveillance study required by Japanese Regulatory Authorities as~     a condition of approval~   "
30064|NCT02663726|"~     There is evidence that yoga has beneficial effects on several aspects of physical and mental~     health. However, few studies have explored the acceptability and health effects of yoga in~     older adults. This preliminary study will explore the effects of a 10-week yoga intervention~     on physical function and quality of life in older adults. Data collected in this study will~     be used to inform the design of a subsequent adequately-powered randomised controlled trial.~   "
30065|NCT02663713|"~     Taken together the results from CHARISMA and PEGASUS-TIMI54, it appears that physicians may~     consider extending beyond 1 year or reinitiating treatment with clopidogrel 75 mg od or~     ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low~     bleeding risk. Comparative clinical or pharmacodynamic studies, however, between clopidogrel~     75 mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not~     been performed.~      In a platelet substudy of PEGASUS-TIMI 54, 180 patients who had received >4 weeks of study~     medication had platelet reactivity assessment. Ticagrelor 60mg bid achieved high levels of~     peak and trough platelet inhibition in nearly all patients, with similar consistency of~     effect compared to 90mg bid. Platelet reactivity (PRU) was significantly reduced with~     ticagrelor 60mg bid compared to placebo.~      In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg~     vs clopidogrel 75 mg od in a PEGASUS-like population would be informative for the practicing~     clinician, thus setting the rationale for conducting this specifically designed~     investigation.~      This is a prospective, randomized, single blind, single center, crossover study. Eligible~     patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day~     minimum washout period before randomization. Following screening/washout period (visit 1),~     patients will be randomized (visit 2, time 0) in 1:1 fashion to either clopidogrel 75 mg od~     or ticagrelor 60 mg bid. Following 14±2 days (visit 3) patients will receive alternate~     treatment for additional 14 days (visit 4). Platelet reactivity assessment will be performed~     with the VerifyNow P2Y12 reaction assay at time 0, prior to first study drug dose. At visit~     3 platelet function will be assessed at 2-4 hours post dose and prior to crossover. At visit~     4 also platelet function will be assessed at 2-4 hours post study drug post dose. All~     patients will receive concomitant aspirin (100 mg/d) and standard secondary prevention~     medication.~      The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at~     the end of the 2 study periods (pre-crossover and post-crossover).~   "
30066|NCT02663700|"~     This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial~     of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this~     protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in~     malaria-experienced healthy adults. The study duration shall be 34 months and subject~     participation duration shall be 15-26 months.~   "
30067|NCT02663687|"~     This trial is looking to gain information about the safety and tolerability of an~     investigational treatment (SHP623) in healthy adult volunteers. This study will also collect~     pharmacokinetic data (how the body absorbs and breaks down the study drug).~   "
30068|NCT02663674|"~     This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals~     aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility~     criteria in endemic regions. This study is designed to provide data on the effectiveness of~     early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also~     referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in~     subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by~     their health care provider for acute CAP will be randomized to receive either placebo or 400~     mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response~     of early empiric antifungal therapy with fluconazole through Day 22 in subjects with~     coccidioidomycosis pneumonia and are compliant with the study intervention.~   "
30069|NCT02663661|"~     The type 1 Diabetes (T1D) TrialNet Pathway To Prevention (PTP) Study assesses and recruits~     at-risk subjects into clinical trials aimed at preventing the development of full blown T1D.~     Thousands of first and second degree relatives of persons with T1D are screened for~     autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody~     tests. The investigators' ancillary study us designed to test whether characterization of~     the insulin- glucose-glucagon (IGG) interactions in participants in the PTP study can~     provide new information about the early stages of the disease. When completed, this study~     will improve the understanding of the pathogenesis of the early stages of T1D and provide~     new quantitative tools for prediction and evaluation of insulin-glucagon-glucose~     interactions relevant to individuals at risk for developing T1D, thereby enabling future~     preventive intervention trials.~   "
30070|NCT02663648|"~     This study involves observing the level of cell cycle regulatory gene in patients with~     myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential~     thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal~     blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA,~     RNA, protein or plasma will be used in laboratory studies.~      Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk~     inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and~     stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased~     proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was~     still unclear. Detecting the level of cell cycle regulatory protein will be useful to look~     for the possible role in MPD and better understand the cause of MPD.~   "
30071|NCT02663635|"~     A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with~     add-on extended finger flanges~   "
30072|NCT02663622|"~     This is a multicenter prospective randomized phase IIa/IIb clinical trial designed to~     determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host~     Disease) prophylaxis.~   "
30073|NCT02663609|"~     Chart review study to collect patient data from medical charts of patients who have been~     treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.~   "
30074|NCT02663596|"~     The purpose of this investigation is to evaluate the safety of delivering continuous~     infusion (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into~     the CRRT solution(s). The secondary objectives are to describe the ability to achieve~     therapeutic vancomycin concentrations by utilizing this new delivery technique.~      Primary Objectives:~      To determine whether delivering continuous infusion vancomycin mixed into the CRRT solution~     can maintain therapeutic levels of drug in patients being treated for proven or suspected~     Gram-positive bacterial infections.~   "
30075|NCT02663583|"~     The goal of this laboratory research study is to learn about symptoms and activity levels of~     patients with OPSCC that receive IMPT or TORS.~   "
30076|NCT02663570|"~     The aim of our study is to investigate the effects of a treatment with melatonin on~     clinical, endocrine and metabolic features in women affected by PCOS. The study group~     included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual~     pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral~     follicular count, an oral glucose tollerance test and hormonal assays are evaluated before~     and after therapy.~   "
30077|NCT02663557|"~     Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to~     be a major modifiable risk factor for stroke.Even the casual visit hypertension has been~     managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study~     is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure~     variability (BPV) contribute to recurrent stroke.~   "
30078|NCT02663544|"~     This randomized controlled feeding trial aims to determine whether the consumption of~     different amounts and types of dairy products affects blood sugar regulation and~     cardiometabolic health in men and women with the metabolic syndrome.~   "
30079|NCT02663531|"~     Alzheimer´s disease (AD) in one of the most important causes of dementia and poses a~     considerable challenge in health care. Today, criteria for the diagnosis and the follow up~     of patients with AD mainly rely either on subjective tests or invasive methods. This limits~     the general applicability of the latter test for population screening and underlines the~     need for the identification of easily accessible tools for the identification of high-risk~     subjects. Because of its unique optical properties, the eye offers the possibility of the~     non-invasive assessment of both structural and functional alterations in neuronal tissue. As~     the neuro-retina is part of the brain, it does not come as a surprise that~     neuro-degenerative changes in the brain are accompanied by structural and possibly also~     functional changes in the neuro-retina and the ocular vasculature. The current study seeks~     to test the hypothesis that beside the known anatomical changes, also functional changes can~     be detected in the retina of patients with AD. For this purpose, flicker light induced~     hyperemia will be measured in the retina as a functional test to assess the coupling between~     neural activity and blood flow. Further, structural parameters such as retinal nerve fiber~     layer thickness and function parameters such as ocular blood flow and retinal oxygenation~     will be assessed and compared to age and sex matched controls.~   "
30080|NCT02663518|"~     Multicenter, open-label, Phase 1a/1b trial of TTI-621 in subjects with relapsed or~     refractory hematologic malignancies.~   "
30081|NCT02663505|"~     Capacity on intensive care units is limited but inevitable for high risk surgery and/or high~     risk patients i.e. patients with severe preconditions.~      Contrary, if there is no capacity on an ICU elective surgery has to be postponed.~      The aim of this study is to evaluate the current allocation process of ICU capacities and~     analyze parameters important for ICU admission in an university hospital in Germany. In a~     second phase a risk score for ICU admission shall be invented from parameters obtained~     during phase one (ICU-Risk-Score). This new score will then be evaluated in a third phase of~     the project.~   "
30082|NCT02663492|"~     To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced~     bone marrow suppression in patients with lung cancer.~   "
30083|NCT02663479|"~     The purpose of this study is to evaluate the efficacy and safety of a proprietary~     nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group~     of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive~     agents or other nutraceutical supplements.~   "
30084|NCT02663466|"~     Background. Limberg flap, one of the recently being popularized off-midline closure~     techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus;~     however, recurrences still can be seen.~      Objective. The aim of this study was to assess the relationship between recurrence and~     off-midline closure errors made in Limberg flap reconstructions.~      Design. A multicenter, matched-case-control study was conducted in three participating~     centers in Turkey.~      Settings. Each hospital's database was searched separately and all patients with and without~     recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were~     identified.~      Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases~     of recurrence-free patients for at least 5 years following surgery (non-recurrent group,~     NRG) were included to the study.~      Interventions Main outcome measures. According to the off-midline closure concept, LF~     reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct~     closures (type 4, 5 and 6). Then the two groups were analyzed.~   "
30085|NCT02663453|"~     The purpose of this study is to compare the effects of a multicomponent lipid emulsion~     containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil~     with a conventional pure soybean oil lipid emulsion on the incidence of neonatal~     cholestasis, infant growth, infant morbidity and the biochemical assessment of liver~     enzymes.~   "
30086|NCT02663440|"~     Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With~     Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With~     Newly Diagnosed Glioblastoma Multiforme.~   "
30087|NCT02663427|"~     The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined~     with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening~     in community of Wuxi City.~   "
30088|NCT02663414|"~     The objective of this study is to collect post market data on safety and performance of the~     Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment~     through a 24 months post-operative follow-up period.~   "
30089|NCT02663401|"~     This study evaluates the impact of the introduction of a front-of-pack nutrition label on~     fods and beverages sold in a campus cafeteria in France on the nutritional quality of~     purchases. The design involves one site with the intervention and one control site with the~     same consumer and product characteristics.~   "
30090|NCT02663388|"~     The purpose of this study was to evaluate the role of vitamin status and epigenetic~     mechanisms on severe obesity related-complications.~   "
30091|NCT02663375|"~     Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™~     Delivery System implantation in patients presenting severe symptomatic aortic stenosis to~     collect continued surveillance data pertaining to safety and performance of the device.~   "
30092|NCT02663362|"~     The purpose of this study is to develop and refine the techniques for using magnetic~     resonance imaging and magnetic resonance spectroscopy to understand the composition and~     function of the human body~   "
30093|NCT02663349|"~     Maintenance of employment is dependent upon being able to successfully integrate into one's~     work setting. This can present a significant challenge to individuals with serious mental~     illness, as they typically exhibit impairment in their ability to accurately perceive and~     understand social exchanges. Presently the most established intervention is Social Cognition~     and Interaction Training (SCIT), a 12-week group intervention in which participants learn~     strategies to enhance emotion recognition and to assess the accuracy of their interpretation~     of social interactions. To enhance transfer of training gains to functional outcomes,~     participants will be paired with a social mentor to facilitate completion of homework and to~     ensure that skills are practiced outside of treatment (supported SCIT). The study will~     examine the impact of supported SCIT on social and work role functioning.~      The specific aims are:~        1. To assess the feasibility of providing supported SCIT to individuals with serious~          mental illness who are engaged in compensated work activity.~        2. To assess the impact of supported SCIT on social cognitive skills as well as work and~          social performance.~        3. To assess durability of intervention-induced change 3 months after the end of~          intervention.~      A randomized, active-placebo controlled, parallel groups, single blind study will be~     conducted in which 60 participants between 18-60 with serious mental illness (schizophrenia,~     schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT~     or an active placebo condition, a computer skills course. Each intervention will consist of~     two 1-hour small group training sessions and 1 hour of individualized supported practice of~     skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at~     group and individual sessions. Baseline, post-intervention, and follow-up assessments will~     measure social cognitive abilities and functional outcomes . Potentially confounding~     variables such as symptom severity and outside treatment hours will also be assessed. It is~     hypothesized that supported SCIT will be completed by at least 75% of veterans assigned to~     that condition. The intervention is predicted to improve social cognitive skills and social~     and work performance. Training gains are expected to be sustained 3 months after~     intervention.~   "
30094|NCT02663336|"~     The purpose of this study is to determine the percentage of patients with masked~     hypertension in a population with chronic kidney disease. The investigators goal is to~     register prospectively ambulatory blood pressure measurement results of patients of a~     nephrological outpatient clinic with normal office blood pressure to finally find the~     percentage of masked hypertension in this population.~   "
30095|NCT02663323|"~     MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm,~     open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus~     Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native~     coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia~     Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of~     population reporting Major Adverse Cardiac Events at 6 months from the day of index~     Procedure.~   "
30096|NCT02663310|"~     The purpose of this study is to investigate the efficacy of surgical~     decompression/untethering, combined with weight bearing rehabilitation, on neurological~     recovery following chronic spinal cord injury.~   "
30125|NCT02662933|"~     AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated~     13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with~     significantly lower survival rates reported for older adults. SEER statistics from 1996-2003~     show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those~     ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older~     adults with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced~     increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have~     therefore been used in research and clinical practice due to concerns regarding toxicity~     associated with treatment. The reasons for the increased toxicity and decreased survival in~     older adults with AML is incompletely understood and likely multifactorial including both~     tumor specific and host specific factors. Improving understanding of which measurable~     clinical characteristics predict vulnerability to toxicity will help refine the research and~     clinical approach to older adults with AML.~   "
30097|NCT02663297|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by~     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which~     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are~     special infection-fighting blood cells that can kill other cells, including tumor cells or~     cells that are infected. Both antibodies and T cells have been used to treat patients with~     cancers. They both have shown promise, but neither alone has been sufficient to cure most~     patients. This study is designed to combine both T cells and antibodies to create a more~     effective treatment. The treatment that is being researched is called autologous T~     lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30)~     administration.~      In previous studies, it has been shown that a new gene can be put into T cells that will~     increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes~     make up the chemical structure carrying the patient's genetic information that may determine~     human characteristics (i.e., eye color, height and sex). The new gene that is put in the T~     cells in this study makes a piece of an antibody called anti-CD30. This antibody floats~     around in the blood and can detect and stick to cancer cells called lymphoma cells because~     they have a substance on the outside of the cells called CD30. Anti-CD30 antibodies have~     been used to treat people with lymphoma, but have not been strong enough to cure most~     patients. For this study, the anti-CD30 antibody has been changed so that instead of~     floating free in the blood part of it is now joined to the T cells. Only the part of the~     antibody that sticks to the lymphoma cells is attached to the T cells instead of the entire~     antibody. When an antibody is joined to a T cell in this way it is called a chimeric~     receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of~     the tumor, but they do not last very long in the body and so their chances of fighting the~     cancer are unknown.~      The purpose of this research study is to determine a safe dose of the ATLCAR.CD30 cells that~     can be given to subjects after undergoing an autologous transplant. This is the first step~     in determining whether giving ATLCAR.CD30 cells to others with lymphoma in the future will~     help them. The researchers also want to find out what side effects patients will have after~     they receive the ATLCAR.CD30 cells post-transplant. This study will also look at other~     effects of ATLCAR.CD30 cells, including their effect on your cancer and how long they will~     survive in your body.~   "
30098|NCT02663284|"~     A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain~     assessment tool based on the analysis of the variability heart rate which evaluates the~     Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.~      The aim of the present study is to assess the validity of the ANI parameter in patients with~     Complex Regional Pain Syndrome treated with a nerve block (reversible pain).~   "
30099|NCT02663271|"~     Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of~     the central nervous system in adults. Despite an aggressive multimodality treatment approach~     including surgery, radiation therapy and chemotherapy, overall survival remains poor.~     Novocure has shown that when properly tuned, very low intensity, intermediate frequency~     electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM~     Therapy) is a portable battery operated device, which produces TTFields within the human~     body by means of surface transducer arrays. The TTFields are applied to the patient by means~     of surface transducer arrays that are electrically insulated, so that resistively coupled~     electric currents are not delivered to the patient. Optune is currently FDA-approved as a~     single modality treatment for recurrent GBM when both surgical and radiotherapy options have~     been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM.~      This research study is being performed to determine whether or not TTFields combined with~     pulsed bevacizumab treatment increases overall survival in patients with~     bevacizumab-refractory GBM compared to historical controls treated with continuous~     bevacizumab alone or in combination with other chemotherapy.~   "
30100|NCT02663258|"~     Abbreviated Title: An explorative Phase II study of Anti-PD-1 (Pembrolizumab) in patients~     with advanced melanoma (ADAPTeM)~      Trial Phase: Phase II~      Clinical Indication: Stage III unresectable/stage IV metastatic melanoma~      Trial Type: Exploratory Phase II trial~      Route of administration: Intravenous Pembrolizumab, 200mg, 3weekly~      Trial Blinding: Unblinded; open label Phase II study~      Treatment Groups: All participants treated with Pembrolizumab, 200mg iv, 3weekly~      Number of trial subjects: 40~      Estimated duration of trial: 24 months~      Duration of Participation: 24 months~   "
30101|NCT02663245|"~     The intensification of the management for the control of glycaemia and other risk factors in~     patients with type 2 diabetes (DM2) results in a reduction of diabetes-related~     complications.~      The strategy to increase the competences of primary care professionals to improve health~     care has been mainly prompted by the current context of limited resources and restricted~     access to specialty care.~      This study aims to evaluate the effectiveness and cost-effectiveness of an integral~     intervention carried out by primary care professionals with the following components:~        1. detection of patients with poor diabetic control;~        2. introduction of a specific consultation on diabetes followed by virtual and telephone~          specialist support;~        3. introduction of other measures to overcome patients and professionals barriers to~          treatment.~      The main objective of the study is to determine if glycaemic control as measured by the mean~     concentration of HbA1c of poorly controlled patients improves when these patients are~     evaluated and treated in primary care under the integral strategy proposed in this study.~     The INTEGRA project also includes Phase 1 (qualitative research study), which is aimed at~     identifying viable strategies to suppress barriers to treatment; these strategies have been~     included to the intervention study (phase 2).~      Phase 2 is a controlled, quasi-experimental intervention that involves 9 primary care~     centres of 3 regions (Lleida, Girona, Barcelona). The participants are patients with DM2~     with poor glycaemic control that meet all the inclusion criteria and sign the informed~     consent. The intervention study will have three arms: (1) Control Group; (2) Intervention~     Group 1 (diabetes specific consultation + additional measures originated in phase 1; and (3)~     Intervention Group 2 (additional measures originated in phase 1).~      Phase 1 has been conducted during the last 6 months previous to the initiation of the~     proposed intervention study and consisted of a qualitative design (individualized interviews~     with randomly selected patients in each of the participating centers); this qualitative~     study has contributed to design the final intervention applied on phase 2, particularly,~     implementing additional measures as coaching sessions to health professionals of the~     participating centers and automated messaging to patients with reminder and motivational~     objectives.~      Phase 2 consists of a recruitment period of 6 months, followed by a 12-month follow-up for~     each patient~   "
30102|NCT02663232|"~     This is a national, multicenter, cross-sectional epidemiological study in adult Spanish~     participants diagnosed with advanced or metastatic melanoma.~   "
30103|NCT02663219|"~     The purpose of this study is to develop and assess the efficacy of an integrated strategy~     that includes feasible and scalable interventions to identify, recruit, link to care, retain~     in care, attain, and maintain viral suppression among HIV-infected men who have sex with men~     (MSM) in the United States (US).~   "
30104|NCT02663206|"~     To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in~     spastic esophageal disorders.~   "
30105|NCT02663193|"~     The purpose of this study is to characterize the tolerability profiles of enzalutamide and~     abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS)~     tolerability-and quality of life (QoL) after approximately 2 months of participants starting~     treatment with one of these agents for metastatic castration-resistant prostate cancer~     (mCRPC).~   "
30126|NCT02662920|"~     Prevalence and prognostic significance of polypharmacy has not been evaluated in adults~     undergoing treatment for AML. Investigating the significance of polypharmacy in this~     population may help improve patient assessment and provide an opportunity to design simple~     interventions to minimize unnecessary morbidity associated with treatment.~   "
30127|NCT02662907|"~     The goal of this clinical research study is to learn if exercising the muscles that help you~     cough and swallow, called expiratory muscle strength training (EMST), can help reduce the~     risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients~     who have had radiation for head and neck cancer.~   "
30106|NCT02663180|"~     Depression is a serious mental health disease. It is generally characterized by sadness,~     loss of interest in activities, and decreased energy. Globally, it is estimated that almost~     350 million people suffer from depression. In Saudi Arabia, literature suggested that~     prevalence of depression among boy's secondary school students in Abha city was 38.2%.~     Another study found that the prevalence of depression was 22.4 % as moderate, 7.3 % as~     severe and 3.7% as very severe, with a clear predominance prevalence of depression in girls~     as in boys (1.5 times). It is important to assess depression literacy including knowledge~     and beliefs about mental disorders among adolescent. A high level of mental health literacy~     on depression leads to a better understanding and outcomes of depressive disorders. Schools~     are a typical venue in which to embed mental health literacy because the school students are~     more familiar with educational activities. Studies concluded that educational intervention~     about depression literacy and destigmatization improves knowledge and may decrease stigma.~     Further research, intervention and activism are needed in the field of mental health in Arab~     countries to improve awareness of mental health problems.~      Objectives: This study is aimed to measure the effect of educational intervention program~     about depression among secondary schools in Jazan city on depression literacy and stigma~     during the academic year 2015-2016.~      The intervention: the intervention will held at each selected intervention school~     separately. The program will be over 2 weeks intervention as the following:~        -  Educational strategies: 2 Lecture about depression 30 minutes supported by group~          discussion, brochures and display of posters with mental-health slogans on depression~          in the schools.~        -  Contact strategies: the investigators will show a video of a young male who had been~          diagnosed (i.e., not an actor) with depression.~      Benefits:~      * The intervention group will join educational intervention program they expected to benefit~     from the program through increase their depression literacy and improve depression stigma,~     and control group will not join any form of intervention.~      Risk: There is no expected risk for participating in the study.~      Consent: Three Informed Consents forms will be signed from students, guardians and school~     manager.~   "
30107|NCT02663167|"~     The purpose of this study is to evaluate the feasibility and effectiveness of~     Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with~     Obsessive-Compulsive Disorder (OCD).~   "
30108|NCT02663154|"~     Postoperative nausea and vomiting (PONV) is one of the most common postoperative~     complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting~     are approximately double those of adult patients. Aromatherapy has recently been shown to~     reduce PONV in adults, but the effect in paediatric patients is unknown. The goal of this~     study is to determine the feasibility of a large-scale study in the paediatric population.~   "
30109|NCT02663141|"~     The aim of this study is to determine whether oral losartan is effective in the treatment of~     diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).~   "
30110|NCT02663128|"~     The purpose of this study is to measure how much of a new tablet formulation of AZD3293 gets~     into the blood stream and how long it takes the body to get rid of it, compared to the~     current tablet formulation of AZD3293. The effect of a high fat meal on how quickly the body~     absorbs the new tablet formulation will also be evaluated. In addition any side effects of~     the study drug using both the new and current tablet formulations will be evaluated. The~     study will last about 22 days, with screening required within 30 days prior to the start of~     the study.~   "
30111|NCT02663115|"~     Project aim is to quantify the influence of a severe therapy-refractory heart failure caused~     by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular~     biological parameters and on the M. vastus lateralis. The control group consists of patients~     with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated~     for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure~     (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The~     ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of~     the analyses muscle catabolism.~   "
30112|NCT02663102|"~     The purpose of this study is collect safety information on the use of Fluarix Tetra~     according to the approved PI, over a period of 6 years from children (over 3 years of age)~     and adults in Korea.~   "
30113|NCT02663089|"~     Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the~     treatment of Chronic Obstructive Pulmonary Disease (COPD). Absorption, metabolism and~     excretion of batefenterol have been studied in animals, in vitro, and in previous clinical~     studies; however, the elimination routes and metabolic pathways of batefenterol have not~     been fully elucidated in humans. This is an open-label, single centre, non-randomised,~     2-period single-sequence crossover, mass balance study to determine total radioactivity~     (drug related material) in plasma, the rate and extent of excretion of total radioactivity~     in urine and faeces and the total recovery of radioactivity of [14C] GSK961081 administered~     as a single IV dose (concomitant with an inhaled non-radiolabelled dose) and a single oral~     dose, in healthy male subjects. A total of 6 healthy male subjects will be enrolled. The~     duration of each subject in the study is up to 11 weeks, which consists of a screening~     visit, 2 Treatment Periods, and a follow up visit.~   "
30114|NCT02663076|"~     The multicenter registry will collect clinical data from 2500 patients with non valvular~     atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).~      The overall objective of this registry is to assess chronic kidney disease (CKD) progression~     and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR~     15-49 mL/min per 1.73 m2 in routine clinical practice.~   "
30115|NCT02663063|"~     The study aims to explore the effects of silver spike point (SSP) treatment on common~     symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer~     patients.~   "
30116|NCT02663050|"~     Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of~     treatment strategies are being held. But invasive and pharmacological therapies have good~     outcome with systemic side effects. Kinesio taping is being widely used in different pain~     conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention~     method which can be used in outpatient practice without systemic side effects.~   "
30128|NCT02662894|"~     Noninferiority trial to assess efficacy of fixed-dose combination of valsartan +~     rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.~   "
30129|NCT02662881|"~     This study will evaluate the performance of biologically assisted core decompression with~     the PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The~     study will explore the potential impact of patient demographics and baseline characteristics~     on post-operative outcomes.~   "
30130|NCT02662868|"~     The purpose of this study is to describe demographics and socioeconomics characteristics~     associated to the diagnosis of metastatic breast cancer in Brazil.~   "
30131|NCT02662855|"~     The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a~     broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is~     the most difficult aspect for clinical management of EVD due to its high fatality rate.~   "
30117|NCT02663037|"~     Background: The delivery of targeted, patient-centered care for a population with~     heterogeneous healthcare needs while moderating costs is a key challenge in healthcare.~     Segmentation of patient populations based on clinically distinguishing features and social~     healthcare needs is currently a promising method for informing the organization of~     healthcare supply to these needs.~      Aims: In this prospective cohort study, the investigators aim to assess the Simple~     Segmenting Tool (SST) as a method of patient population segmentation in terms of its~     inter-rater reliability, as well as convergent and predictive validity. We will also revise~     the tool based on feedback from the validity studies should the need arises.~      Hypothesis: The investigators hypothesize that the SST is able to exhibit good inter-rater~     reliability, convergent validity and predictive validity for adverse events.~      Methodology: Non-critical patients aged 55 and above presenting to the Emergency Department~     will be screened with the SST. Raters will be paired in order to assess inter-rater~     reliability. To test convergent validity, the LACE, SF-12, and Clinical Frailty Scale (CFS)~     will also be used. Finally, predictive validity will be assessed by evaluating adverse event~     rates of patients in each SST category. Adverse events include all-cause mortality, length~     of hospital stay, emergency department visit and unplanned hospital readmission.~      Significance to Health Services Delivery: This study will provide evidence supporting the~     use of a standardized tool for evaluating the medical and social needs of patients at~     various sites of care. Following which, tailored packages of healthcare services can then be~     delivered in order to meet these needs.~   "
30118|NCT02663024|"~     This study evaluates the efficacy and safety of three doses of GC1111 in patients with~     Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or~     comparator.~   "
30119|NCT02663011|"~     Purpose:~      To assess age and gender effect in the language error type (semantics, syntax and~     pragmatics)of developmental delay preschool aged children, a standardize tool Preschool~     Language Scale Corrected edition(PLS-C), Lin was adopted for evaluation.~      Methods:~      This is a retrospective chart study enrolled 55 children aged 3, 4 and 5 in department of~     rehabilitation in Taipei Medical University Hospital from 2011 Jan to 2014 Dec whose average~     PLS-C score was at least 1.5 SD below normal. Those normal or PLS-C score was less than~     1.5SD below normal were excluded. We recorded correct percentage in pragmatics, syntax, and~     semantics in different age group separately in auditory comprehension, language expression~     as well as overall performance. All wrong questions answered in PLS-C were recorded. We used~     SAS 9.4 (Anova, t-test) to analyze the results in age differences, gender differences, and~     language components differences~      Results:~      In overall performance, expression, and comprehension, there was no difference between boy~     and girl by t-test in all ages. By one-way Anova Bonferroni t test, age 5 was better than~     age 4 and age 3 significantly in pragmatics, syntax and semantics (p<0.005).~      We further separated into groups of 5YR boy, 5YR girl, 4YR boy, 4YR girl, and 3YR boy.~      In overall performance, by Duncan's multiple analysis, only 5 YR boy had significant better~     performance than 4 YR girl and 3 YR boy in pragmatics. In age 5, boys had better performance~     in pragmatics than girls (p<0.05). In age 4, no differences are showed between boy and girl.~      In comprehension, in age 5, boys have better performance in pragmatics than girls(p<0.05).~      In expression, there was no difference between boys and girls. Pragmatics was better than~     syntax (p=0.0202<o.o5) in age 5.~      Conclusion:~      We found age had more effect than gender in language delay children. Age 5 boys had better~     performance in pragmatics conflicted with some previous studies and may need more~     exploration in the future.~      Key words:~      Development Delay, Preschool aged children, Language Development Delay, Semantics, Syntax,~     Pragmatics, Language error type~   "
30120|NCT02662998|"~     The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to~     detect significant hearing impairment as part of a comprehensive geriatric assessment in~     patients aged 70 years and older. The pass or fail screening cut-off is defined as having~     two or more consecutive hearing grades starting from the moderate-severe threshold zone~     ranging from 0.5 - 2.0 kHz.~   "
30121|NCT02662985|"~     This study is designed to leverage the sensitivity of ultrasonography available in clinical~     practice setting to better describe the time course of response to secukinumab (150 mg and~     300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to~     non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global~     Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR)~     synovitis score (GLOESS) and changes in joint enthesitis will be assessed using the OMERACT~     enthesitis score.~   "
30122|NCT02662972|"~     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not~     have enough effect with the available pharmaceutical treatments and are offered surgery.~     There are different types of procedures and most of them are complex with a risk for~     complications. The researchers want to start a pilot study on 10 patients with a new~     surgical technique using neuronavigation. The target will be a neural structure~     (sphenopalatine ganglion) which has an important role in facial pain. There have been a few~     trials trying to block this structure in trigeminal neuralgia, but none using this new~     approach with botulinum toxin. The researchers technique requires local anesthesia only~     (awake patient). The researchers believe that this treatment can become a low~     threshold-treatment for patients who do not have enough effect with pharmacological~     treatment and a better alternative to other complex surgical approaches. Using this new~     neuronavigation system the researchers can reach this neural structure with high precision.~   "
30123|NCT02662959|"~     Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable~     or metastatic disease at the time of diagnosis. Systemic therapy was required for the~     patients with advanced stage. Platinum combined with fluoropyrimidines always were~     considered as first line treatment. After failure of initial therapy, single agent of~     taxanes was used as second line treatment. However, there is no relative standard~     chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib.~     So this study was designed to explore the role of single agent with irinotecan as third line~     treatment in patients with metastatic gastric cancer in China.~   "
30124|NCT02662946|"~     A randomized controlled multicenter trial on the usefulness of intraoperative angiography~     with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic~     rectal resection or left colectomy.~   "
30160|NCT02662335|"~     This randomized clinical trial studies computerized cognitive retraining in improving~     cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as~     thinking and memory issues, are common among breast cancer survivors. The severity of these~     cognitive deficits is associated with a significant negative impact on daily function and~     quality of life. A computerized cognitive retraining method may help researchers find ways~     to improve cognitive function and quality of life in breast cancer survivors.~   "
30161|NCT02662322|"~     The purpose of this study is to compare three communications during peripheral intravenous~     catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with~     negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).~   "
30196|NCT02661854|"~     The purpose of the study is to evaluate the more efficient dose for the treatment of~     rhinitis/rhinoconjunctivitis against mite allergy~   "
30132|NCT02662842|"~     Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to~     improve quality of life and glucose control in many patients with diabetes opting for this~     treatment modality. Despite significant innovation and advancement in pump technology,~     insulin infusion sets have been an area where innovation has been significantly lacking with~     no clinical studies performed prior to product launches.~      BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address~     patient comfort, insulin delivery and flow interruptions. According to preliminary animal~     and clinical studies, this technology results in lower infusion pressure indicating more~     consistent insulin delivery.~      The FlowSmart infusion set has been previously tested in prototype form with healthy~     non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who~     self-inserted the FlowSmart infusion set in a clinical research setting.~      The purpose of this study is to determine if insulin pump users prefer using the BD~     FlowSmart infusion set compared to their current set with respect to insertion pain and wear~     comfort.~   "
30133|NCT02662829|"~     Lesotho, a small, landlocked country completely surrounded by South Africa, is among the~     world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB)~     and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV~     coinfected. Data from similar settings suggest that TB incidence in children is~     approximately 50% of adult TB incidence. The Lesotho National TB Program has adopted World~     Health Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child~     contacts; however, as in other countries in the region, implementation of IPT in children is~     limited, no clear strategies guide child contact tracing and screening, and no clear methods~     ensure provision of IPT in children. Thus, it is important to evaluate novel methods to~     prevent TB in child contacts of adult TB cases.~      The purpose of the PREVENT Study is to identify an effective and acceptable intervention~     that addresses programmatic, structural and psychosocial barriers to contact tracing,~     screening, and IPT for child contacts of TB patients, with the ultimate goal of improving~     health outcomes among children in Lesotho. The study is a two-arm cluster randomized trial,~     randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics~     are randomized to deliver the community-based intervention (CBI) or standard of care (SOC),~     with stratification by facility type. The experimental intervention will be delivered to all~     child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics~     assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.~   "
30134|NCT02662816|"~     Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates~     also in the detoxification of electrophiles molecules of which paracetamol. It is~     synthesized in the liver during the postprandial phase, which establishes a stock that is~     mobilized for the other tissues (muscle)during the postabsorptive period. It is of common~     knowledge that the decrease in glutathione concentrations associated with ageing could be~     involved in the development of the degenerative pathologies linked to the old age. These~     changes could be reversed by an increase in dietary cysteine, the amino acid limiting of the~     endogenous synthesis of GSH. The development of nutritional strategies aiming at an~     improvement of the status glutathione requires the determination of its concentration within~     tissues, where it is active. The quantification of tissue concentrations of glutathione by~     biochemical techniques requires tissue biopsies. Such a method can be performed for the~     muscle, but liver biopsy is not feasible outside of a surgery. It is necessary to set up a~     non-invasive method to quantify muscle and liver glutathione.~   "
30135|NCT02662803|"~     This study investigate the effect of high-intense aerobe exercise training (HIT) on clinical~     and physiological parameters (anxiety, somatisation, cortisol, alpha amylase, mismatch~     negativity, loudness dependence auditory evoked potentials) in patients with generalized~     anxiety disorder (GAD). Half of patients will receive HIT, while the other half will receive~     aerobe exercise of low intensity.~   "
30136|NCT02662790|"~     The current study aims to investigate the effects of dexamethasone exerted on fetal and~     uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for~     preterm birth after 24 hours of its administration.~   "
30137|NCT02662777|"~     This international, prospective and multicenter registry was designed to collect clinical~     evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after~     esophageal resection or iatrogenic or spontaneous esophageal perforation.~   "
30138|NCT02662621|"~     Recent studies shows that extracellular vesicles (named exosomes) released by cancer cells~     exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal~     cells. These exosomes (HSP70-exosomes) have a very important role in intercellular~     communication and have specific biological functions that can promote tumor progression.~     They are found in the different biological fluids such as blood and urine.~      We have developed a protocol able to isolate exosomes in blood and urine. We also~     demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those~     results strongly suggest that we can only identify exosomes with HSP70 at the membrane in~     patients with cancer.~      Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research.~     Because a cancer cell can releases a large amount of exosomes (several billion) and since~     its appearance, our approach will allow to earlier detect cancer with respect to the use of~     imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1~     billion cells).~      The aim of this study is to demonstrate that HSP70-exosomes could be used for early~     diagnosis of patients with malignant solid tumor. In order to demonstrate this, the~     objective of the study is to study blood and urine samples from 60 subjects with a malignant~     tumor and 20 healthy subjects (witness).~   "
30139|NCT02662608|"~     The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an~     attempt to control tumors and prolong survival. The therapy involves participant being given~     the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This~     is considered an investigational treatment.~   "
30162|NCT02662309|"~     ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial~     for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the~     bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include~     extensive biomarker work on samples from these patients. Eligible patients will receive two~     3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed~     up for safety, survival, and disease data.~   "
30140|NCT02662595|"~     The question that this project seeks to answer, is whether mobile phones can be used to~     increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention~     will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating~     evidence that could help policy makers making informed decisions about implementing mHealth~     interventions at a national level.~      The intervention takes the form of a randomized controlled trial in which text messages~     (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage~     them to have their children timely vaccinated against measles. In addition, the messages~     will include relevant information about opening hours and availability of the measles~     vaccine at the mothers' local health facilities thus improving coordination. The trial will~     include three different randomization groups with approx. 350 participants in each group.~     The first group will receive SMS messages, the second group will receive a voice call in~     addition to the SMS messages, and the third group is a control group that does not receive~     any intervention.~      Study participants will be enrolled following birth at one of three health centers in~     different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be~     given, at 9 months of age, mothers will receive the intervention message depending on their~     assigned randomization group. When the measles vaccine is administered, the child will be~     registered as having received the measles vaccination.~      A follow-up phone interview will be conducted at 12 months of age for all children~     participating regardless of randomization group and whether or not they received the measles~     vaccine. All participating children, who at that time still have not received the measles~     vaccine, will be offered the vaccine at the expense of the project.~   "
30141|NCT02662582|"~     The purpose of this study is to assess the effect of CK-2127107 relative to placebo on cycle~     ergometer exercise tolerance, assessed as change from period baseline in constant work rate~     (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with~     integrated electrocardiogram (ECG). The time to intolerance is assessed by a stopwatch and~     verified from electronic recordings of the cycle ergometer.~      This study will also assess cardiopulmonary and neuromuscular effects of CK-2127107 relative~     to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety~     and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.~   "
30142|NCT02662569|"~     The primary hypothesis is that both dosing regimens of SC evolocumab (AMG 145) in~     combination with statin therapy will be well tolerated and will result in greater reduction~     of LDL-C in diabetic subjects with hyperlipidemia or mixed dyslipidemia.~   "
30143|NCT02662556|"~     This is a multicenter, open-label study in patients 40 years and older who are undergoing a~     surgical procedure.~      Patients may receive one dose of ST 30 mcg as needed for pain management, but no more~     frequently than every 60 minutes, for up to 12 hours.~   "
30144|NCT02662543|"~     This study is designed to estimate the changes in the etiology and epidemiology of acute~     gastroenteritis in children aged less than 18 years after the implementation of rotavirus~     vaccine in the Estonian national immunization program in July 2014.~   "
30145|NCT02662530|"~     This study investigates the use of a kinematic measurement device to quantify the abnormal~     head movements and postures in patients with cervical dystonia (CD) in order to~     individualize and optimize botulinum toxin type A (BoNT-A) injection therapy. A single~     sensor captures five degrees of freedom of the neck and head that distinguish which~     muscle(s) contribute to CD and the amount of BoNT-A to inject into these muscle(s). The~     efficacy, relief and improvements in social, occupation and function by injections will be~     investigated. The efficacy of BoNT-A therapy using either BoNT-A injection parameters from~     clinical-based assessments and kinematically-based assessments will be investigated in CD~     patients. Individuals clinically diagnosed with CD will be randomized for two treatment~     conditions: A) injection parameters from a kinematic assessment only, or B) injection~     parameters from a clinical assessment only.~   "
30146|NCT02662517|"~     Human breast milk contains growth factors including neurotrophins and cells with~     neuroprotective potential. Concerning growth factors milk of preterms differs significantly~     from term milk. The aim of this study is to give a profile of human milk concerning~     non-nutritive factors depending on gestational age and lactation phase.~   "
30147|NCT02662504|"~     Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median~     survival <13 months), and high resistance to chemotherapy. Extended~     pleurectomy/decortication (eP/D) is a debulking surgery of MPM but cannot be considered as a~     curative treatment. Therefore it has been suggested that eP/D may be of interest if combined~     with intra-operative treatment and adjuvant therapies.~      Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour~     cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed~     to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour~     immune response through the release of tumour antigens and induced inflammation.~      PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and~     chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM~     when combining eP/D, but not EPP, intra-operative PDT and chemotherapy~     (cisplatin-pemetrexed), with a median overall survival of 31.7 months.~      However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM~     still need to be validated. The same multimodal treatment has been established in Lille, the~     French national expert centre for MPM, with the help of our american colleagues. Therefore,~     this phase II trial proposes to patients to benefit from the combination of eP/D,~     intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.~      Primary endpoint is the feasibility for the patients to have the full multimodal treatment~     of MPM including intrapleural PDT without unacceptable or unexpected grade III-IV~     toxicities. Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of~     such treatment would be confirmed in France, a multicentric, randomized trial comparing this~     experimental treatment vs control arm (same multimodal treatment without PDT) is planned.~   "
30148|NCT02662491|"~     The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU),~     calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D~     deficiency will lead to a clinical benefit. The proposed study will also determine the~     threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's~     health~   "
30149|NCT02662478|"~     Despite laparoscopic surgical treatment has not been recommended in patients with gastric~     gastrointestinal stromal tumors (GIST) larger than 5 centimeter, but it continues to evolve~     rapidly to overcome the boundaries. Therefore the authors generated a morpho-anatomical~     classification system (MACS) adapted for primary gastric GISTs, by which they could plan to~     tailor the laparoscopic gastric resection appropriately. The aims of the study was to~     demonstrate the feasibility of laparoscopic surgery for primary gastric GISTs larger than 5~     cm, to find out the accuracy and practicality of the MACS for the development a preoperative~     strategy and the extent to which this strategy overlaps with the reality.~   "
30163|NCT02662296|"~     This phase II trial studies how well ibrutinib or idelalisib works in treating patients with~     chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is~     persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and~     idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
30164|NCT02662283|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     effect and security of reh-acteoside therapy for patients of IgA nephropathy.~   "
30150|NCT02662465|"~     Before the start of the selected chemotherapy patients will be treated preventively for oral~     mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for~     five days and another will be held to damage preventive therapy (wavelength of 660nm, power~     100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on~     the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients~     who develop oral mucositis even after the prevention, will be divided into three groups for~     laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed~     severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera~     used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients~     with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia~     of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode~     AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency~     of 8 J / cm².~   "
30151|NCT02662452|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part~     1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to~     healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics)~     will be characterized.~      The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222~     will be explored as well.~   "
30152|NCT02662439|"~     The aim of this study is to investigate whether the objective measurement of fluid overload~     by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated~     heart failure would improve the diuretic therapy.~   "
30153|NCT02662426|"~     Name of study:~      Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about~     Lingdancao Granules in the Treatment of Seasonal Influenza~      Objective:~      Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of~     seasonal influenza~      Design:~      Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo~     controlled trial~      Case number:~      This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects.~     Qualified participants are randomly divided into experimental drug group (Lingdancao~     granules group), positive control group (oseltamivir phosphate group) and placebo group, 106~     cases in each.~   "
30154|NCT02662413|"~     To determine the measurement profiles of the asthma control test (ACT) in an adolescent~     population with persistent asthma.~   "
30155|NCT02662400|"~     India is the Diabetes Capital of the World with 41 million Indians having diabetes i.e.~     every fifth diabetic in the world is an Indian. Type 2 Diabetes Mellitus (T2DM) constitutes~     the major chunk of diabetes and has insulin resistance as the hallmark feature in the~     pathogenesis. However, with the progression of the disease the insulin resistance becomes~     stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis. This~     ultimately leads to inability of the β - cells to cope up with the increased demand of~     insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure~     is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study,~     most of the patients with T2DM would eventually require insulin and it would be difficult to~     achieve to attain a strict glycemic control . It is well known that diabetes related~     complications which account for morbidity and mortality in this disease can be prevented or~     delayed by strict glycemic control. However, even with intensive insulin therapy it has been~     shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or~     hypoglycemia during 24 hour glucose profile. Also insulin therapy is not physiological as~     there is no hepatic first - pass metabolism of insulin which is required for halting the~     hepatic glucose output, which is responsible for fasting hyperglycemia. This led the~     researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic~     transplantation and islet cell transplantation. Initially the results of islet cell~     transplantation were dismal but after the induction of glucocorticoid free immunosuppressive~     therapy and the use of adequate number of islet cells from multiple donors, the results of~     islet cell transplantation have been better. However, islet cell transplantation has its own~     limitations viz insufficient supply, being technically demanding and requirement of lifelong~     immunosuppressive therapy in the recipient.~   "
30156|NCT02662387|"~     Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common~     diagnoses in children admitted to pediatric intensive care unit.~      Objectives: The primary outcome of the study is to compare the respiratory parameters~     between patients on HFNC and HFNC with ENDs.~      Methods: This is a prospective randomized controlled trial. All children admitted to Loma~     Linda University Children's Hospital due to acute respiratory failure secondary to~     bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory~     parameters will be collected as part of the study. The investigators anticipate that use of~     END will have a positive impact on the respiratory status of children with acute respiratory~     failure. Appropriate statistical analysis of the data will occur after the data has been~     de-identified.~   "
30157|NCT02662374|"~     Oral mucositis is one of the most common debilitating forms of mucositis that arise from~     high dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing~     hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of~     severity. The objective of this prospective study was to assess the efficacy of the addition~     of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush~     to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2%~     Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the~     severity of oral mucositis among patients receiving chemotherapy for HCT.~      60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15~     patients each The oral mucositis was recorded according to WHO criteria and the progression~     of the oral mucositis was monitored from the day of admission (day~        -  1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and~          salivary flow rate of all patients was recorded.~   "
30158|NCT02662361|"~     To investigate the patient-related risk factors for peri-implant disease in partially~     edentulous patients rehabilitated with implants supported crown or bridge so as to provide~     evidence for clinical prevention and control.~   "
30159|NCT02662348|"~     This phase I trial is to investigate the safety and the possible side effects of bi-specific~     antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients~     with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been~     coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor~     receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells~     from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.~   "
30166|NCT02662257|"~     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone~     with ageing process, more and more elderly patients undergo surgery for malignant tumor.~     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous~     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery.~     Delirium is a commonly occurred early postoperative cognitive complication in the elderly,~     and its occurrence is associated with the worsening outcomes. Choice anesthetics may~     influence the occurrence of postoperative delirium. However, evidence in this aspect is~     conflicting.~   "
30167|NCT02662244|"~     Basal cell carcinoma (BCC) is the most common skin cancer worldwide. Although this tumor is~     rarely life threatening, it is locally destructive and can cause significant cosmetic and~     functional problems. Standard therapeutic modalities for BCC often result in disfigurement~     from surgical treatments and recurrences with topical therapies. Thus, there is a need for~     alternative non-surgical options that are effective, efficient, and have a low risk of side~     effects. This has led to the emergence of laser investigations for the treatment of BCC due~     to the ease of treatment, lack of significant downtime, decreased risk of complications, and~     absence of a surgical scar. The primary objective of this study is to evaluate the safety~     and efficacy of laser treatment of subjects with BCC on the trunk and extremities. Subjects~     will receive one treatment with the laser to the BCC. Standard excision will be performed~     between 30 and 90 days after laser treatment to evaluate resolution of the BCC. A visit for~     suture removal will be performed as appropriate for the site of the surgery. Standardized~     photographs and measurements will be taken at the baseline visit, immediately after laser~     treatment and on the day of excision.~   "
30168|NCT02662231|"~     Surgical site infection (SSI) is the most common complication following major~     gastrointestinal surgery, affecting between 25-40% of patients. The rate of SSI doubles from~     low-income to high-income settings, persisting after risk adjustment. Investigating the~     diagnosis and treatment of SSIs remains a largely unaddressed global health priority. The~     impact of antibiotic resistant organisms and the effectiveness of antibiotic prophylaxis are~     unknown. This study aims to determine SSI rates following gastrointestinal surgery across~     worldwide hospital settings.~   "
30169|NCT02662218|"~     This prospective, multicenter, single-arm observational study aims to document the clinical~     performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for~     the intended use in a daily clinical practice. 50 patients (male/female) with superficial~     wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical~     signs of infection or at high risk of infection and also high to very high exudate levels~     will be observed over a period of 14 days.~   "
30170|NCT02662205|"~     Clients of the student counseling center at Oklahoma State University who are interested in~     participating in the study will be randomly assigned to a traditional process group, a yoga~     class, and a yoga therapy group. Outcome of the three conditions will be compared.~   "
30171|NCT02662192|"~     This study examines the effect of an exercise and health education/auditory rehabilitation~     and socialization intervention on functional fitness, hearing handicap and psychosocial~     distress measures in older adults with hearing loss.~   "
30172|NCT02662179|"~     Identifying the frail elderly patients or those at risk of becoming frail has become a~     cornerstone of modern geriatric medicine. Many instruments have been developed to identify~     fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5~     criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight~     loss. The patient is fragile if it meets at least three out of five criteria. It is~     'pre-fragile' if it meets one or two criteria.~      In onco-geriatrics, the International onco-geriatrics society recommends the implementation~     of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8~     are then referred to the geriatric team to benefit from a comprehensive geriatric~     assessment. This evaluation is interpreted by the geriatrician, who proposes an action plan~     to overcome the various problems of the elderly patient. The evaluation can also help the~     oncologist in the choice of treatment for the patient: palliative care, standard treatment~     or adapted treatment (No-go, Go-go or slow-go).~      The investigators would like to assess if fragility as defined by the Fried criteria is~     predictive of a functional, physical or cognitive decline, or a loss of quality of life in~     patients treated for a solid malignant tumor.~      Furthermore, they will assess if the frailness categorization has an impact on the oncologic~     treatment decision. Does the oncologist switches the patient's oncologic treatment after~     being informed of the frailness status ?~   "
30173|NCT02662166|"~     Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues~     to be a major health problem. This prospective non-randomized study will enroll 150 patients~     undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and~     therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will~     have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT)~     and biomarker collection. After pathology review of the histological specimens, patients~     will be treated according to standard clinical practice. The second MRI examination will be~     performed before therapeutic intervention, if TUR-BT alone is not sufficient enough.~     Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison,~     while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be~     treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the~     neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI~     examination. Low risk patients will be followed by annual with MRI examination.~   "
30174|NCT02662153|"~     Retrospective study to assess incidence and predictors of opioid abuse, addiction, overdose~     & death among patients prescribed ER/LA opioid products~   "
30197|NCT02661841|"~     We aim to determine the effectiveness of lung impedance guided preemptive therapy~     (LI-Guided) of chronic heart failure patients with preserved ejection fraction (LVEF ≥ 45%)~     who are being treated in our hospital's outpatient clinic.~   "
30198|NCT02661828|"~     The purpose of this study is to compare two ways to stop taking an antidepressant medication~     and determine whether a faster or slower taper is better tolerated.~   "
30338|NCT02660008|"~     The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and~     cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic~     Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as~     compared to marketed glucagon.~   "
30175|NCT02662140|"~     The primary purpose of this study is to develop a mobile health (mHealth) application that~     will both advance theory in and clinical practice of homework (HW) implementation. The~     mobile health application will enhance the existing evidence informed curriculum of a~     Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for~     families with children who have disruptive behavior disorders. This mobile application~     consists of two primary components that will support engagement and integration of the~     model's core concepts in family life. The first component focuses on delivering homework via~     a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform~     aimed at improving the Design and Do process of homework.The second component focuses on~     targeting factors putatively related to poor HW implementation within the Do process.~   "
30176|NCT02662127|"~     Venous disease effects 25% of the population and most healthy people experience venous~     symptoms after standing for too long. The prime function of leg veins is drainage. Failure~     leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness,~     swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim~     of the study is to identify blood components (biomarkers) that occur during the damaging~     phase of standing versus the healing phases of lying recovery and with medical compression~     stockings. This will be achieved by taking a blood sample from the ankle region at 3~     separate visits (days) to the vascular laboratory at Ealing Hospital. The first visit will~     be after supervised standing for 1 hour. The second after supervised lying and the third~     standing whilst wearing a medical compression stocking. Healthy volunteers will be compared~     to patients with advanced CVI.~      The potential importance to patients and the public is threefold. Firstly, biomarker~     profiles will be obtained in each of the 3 states to increase understanding in the cellular~     mechanisms of damage and recovery. In this way bad and good biomarkers can be~     identified. Secondly, drug treatments may develop from this research to adjust biomarkers~     towards a favourable profile. Thirdly, the success of treating CVI with surgery, venous~     intervention or compression can be monitored. Whilst it is known that relief of~     gravitational stress is the treatment for all forms of CVI, the mechanisms of repair and its~     discrimination from damage have yet to be identified.~   "
30177|NCT02662114|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness~     of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or~     type 2 diabetes mellitus.~      EU-TREAT (EUropean TREsiba AudiT)~   "
30178|NCT02662101|"~     Chronic non-healing wounds considerably impact quality of life in affected patients and are~     a substantial burden on the Canadian health care system. Microbes colonizing a chronic wound~     play an important role in impeding effective healing. Chronic wounds are colonized by~     polymicrobial communities and no single organism can be seen as causal. Only a small~     fraction of wound bacteria are cultured by diagnostic tests and studies have shown little~     agreement between culture and molecular based approaches, therefore an effective diagnostic~     for wound microbes is required. It is know that the composition of the microbial community~     associated with a wound changes as it heals although the causal relationship is somewhat~     unclear. Although not very effective in treating chronic non-healing wounds, antibiotics are~     often administered, contributing to concerns of antibiotic resistance. The wound dressings~     produced by Exciton Technologies Inc. (ETI) effectively aid in the healing process in~     chronic wounds through unknown mechanisms. ETI's wound dressings contain a combination of~     silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity~     and are effective in reducing biofilm formation in vitro. However, it is not known how these~     silver salts impact microbial ecology of the wound and the role this plays in wound healing.~     The objectives of this research are to develop a new diagnostic tool based on molecular~     characterization of wound sites so as to predict how to best treat wounds and to identify~     new microbes to be targeted by ETI's technology. This project will utilize molecular~     microbial ecology for the assessment and evaluation of topical silver interventions, gaining~     insight into the management of chronic infection. Substantiating the microbiota-modifying~     effectiveness of silver wound dressings towards increasing clinician and patient~     understanding to improving clinical outcomes.~   "
30179|NCT02662088|"~     The purpose of this study is to collect a multi-institutional database including all~     relevant data regarding the surgical and clinical features of patients underwent to~     laparoscopic lavage for complicated colic diverticulitis. The main objectives are:~        -  To determine the surgical and clinical outcomes, in the short and long term.~        -  To compare results according to the different type of techniques, device used and~          manner of execution of the different surgical steps.~        -  To relate results of different surgeries with baseline characteristics of patients and~          stage of disease.~   "
30180|NCT02662075|"~     The primary purpose of this study is to evaluate the acute effects of electronic cigarette~     (e-cigarette) smoking on measurable biomarkers of platelet function, vascular endothelial~     function and inflammation in healthy active smokers. 10 healthy subjects, smokers, with no~     other medical conditions will be included in this study and measurements will be obtained at~     baseline and after smoking an e-cigarette. The study will contribute to the understanding of~     the effects of e-cigarettes on cardiovascular physiology, specifically establishing if the~     use of e-cigarettes increases platelet aggregation and platelet activation when compared to~     baseline in healthy active smokers, if the use of e-cigarettes decreases brachial artery~     flow-mediated dilation compared to baseline in healthy active smokers, and to determine the~     association between biomarkers of inflammation, platelet function, and vascular endothelial~     function before and after use of e-cigarettes.~   "
30181|NCT02662062|"~     This study will enrol patients with maximally resected (via transurethral resection (TURBT)~     non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder~     preservation therapy or are ineligible for cystectomy. Patients must have adequate organ~     function and performance status to receive cisplatin based chemoradiotherapy, and no~     contraindications to the use of pembrolizumab. The study will enrol 30 patients to be~     treated with pembrolizumab and radiotherapy.~      All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions~     over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly~     with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with~     radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and~     assessment.~      Surveillance cystoscopy will be performed 12 weeks after the commencement of~     chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up~     visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will~     commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5~     years.~      The objective of the study is to assess the safety and feasibility of combining~     pembrolizumab with chemoradiotherapy. The primary endpoint assessed will be safety, as~     defined by a satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or~     failure of completion of planned chemotherapy and radiotherapy according to defined~     parameters). The secondary endpoint will be efficacy, as assessed by complete response rate~     of the primary tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory~     analysis will include assessment of tumour histopathological, molecular, genetic and~     immunological parameters.~      It is expected that it will take two years to accrue the required 30 patients.~   "
30199|NCT02661815|"~     Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12~     months of prior treatment that includes Platinum Chemotherapy are invited to take part in~     this study. This research study is studying a combination of a new chemotherapy drug called~     Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a~     possible treatment for this diagnosis.~   "
30183|NCT02662023|"~     Single-injection transversus abdominis plane (TAP) blocks have been used to treat~     postoperative pain, and are become very popular within the United States because of their~     high analgesic potency and relative ease of placement. Unfortunately, the longest local~     anesthetic available lasts only 8-12 hours. Continuous TAP blocks—also termed perineural~     infusion—involve bathing the multiple nerves of the abdominal wall in local anesthetic~     using a percutaneously-inserted perineural catheter inserted just anterior (ventral) and~     cephalad to the anterior superior iliac spine. For most catheter locations, an infusion is~     preferred to a single-injection nerve block because the duration of analgesia may be~     extended to better match the duration of surgical pain. But, unlike brachial plexus,~     femoral, and sciatic nerve perineural infusion, a continuous basal infusion of local~     anesthetic does not provide adequate analgesia for TAP catheters. This may be due to the~     fact that the TAP is a relatively tight space, so it might require a bolus of fluid to~     adequately spread the perineural local anesthetic to the multiple required nerves (as~     evidence of this, single-injection TAP blocks are very effective, although with a limited~     duration). The result is that while single-injection TAP blocks are widely used, TAP~     catheters have not been adopted. This scenario leaves surgical pain untreated following the~     resolution of the single-injection TAP block. The recent development of an infusion pump~     that can automatically deliver repeated bolus doses may allow the spread of local anesthetic~     to the multiple sensory nerves necessary to provide adequate analgesia, with a duration that~     better matches postoperative requirements. The investigators therefore propose a randomized,~     double-masked, controlled trial to determine if delivering local anesthetic as a repeated~     bolus dose results in improved local anesthetic spread/effects compared with a continuous~     basal infusion for TAP catheters.~   "
30184|NCT02662010|"~     The overall purpose of this COMIRB application is to perform a cross-sectional pilot study~     to aid in the design of a prospective epidemiologic study for an NIH grant application. The~     long term goal of this research is to determine if AGEs are predictors of glycemic control~     and the development of diabetic retinopathy in patients with T2DM. Understanding these~     relationships could lead to a prospective prediction of the onset/worsening of diabetic~     retinopathy in T2DM patients and in pre-diabetic individuals.~   "
30185|NCT02661997|"~     The primary aim of this study is to examine the beneficial effects of two novel treatments~     for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the~     efficacy of these mind-body approaches to symptom reduction.~   "
30186|NCT02661984|"~     FeNO measurements provide the physician with means of evaluating an asthma patient's~     response to anti-inflammatory therapy, as an adjunct to the established clinical and~     laboratory assessments in asthma. Interpretation of FeNO profiles is based on the nitric~     oxide plateau. To achieve plateau, the duration of exhalation must be sufficient (at least 4~     seconds for children <12 years and > 6 seconds for children > 12 years (ATS/ERS, 2005).~      Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as~     young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.~   "
30187|NCT02661971|"~     Previous studies provide a strong theoretical rationale for the conduct of a randomized~     study evaluating the efficacy and safety of ramucirumab in combination with FLOT in the~     perioperative treatment of resectable adenocarcinoma of the stomach or GEJ.~   "
30188|NCT02661958|"~     The purpose of this study is to evaluate the superiority in efficacy and assess safety and~     tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active~     components or the vehicle for the treatment of acne.~   "
30189|NCT02661945|"~     Near-focus with narrow-band imaging is a novel technique to improve the quality of images of~     the irregular mucosal structures and microvessels of gastric neoplasms. The investigators~     compare this technique with indio carmin spray, commonly used tool to determine tumor~     margin. The subject are patients who underwent endoscopic submucosal dissection for gastric~     neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo~     carmin groups. First, marking is performed at the tumor margins determined by each modality.~     The distance from the marking dots to the tumor margin is measured histopathologically in~     the resected specimens. Finally, the investigators will compare the accuracy between two~     groups based on the distance from marking dots to tumor margin measured by histopathologic~     examination.~   "
30190|NCT02661932|"~     The purpose of this study is to evaluate efficiency and safety of controlled ovarian~     stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility~     preservation in breast cancer patients.~   "
30191|NCT02661919|"~     Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of~     death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory~     factors are involved. Several ways of preventing SUDEP have been identified. These include~     seizure control, stress reduction, physical activity, family's ability to perform CPR, and~     night supervision.~      A mattress alarm system that monitors nocturnal seizures can alert family members of night~     time seizure activity. Thus, a family member could provide aid and therefore potentially~     avoid SUDEP. The Emfit monitor is intended to perform these tasks.~      Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit~     bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the~     device has a high predictive value for detection of generalized convulsions and that it can~     notify caregivers in the early stages of convulsive activity.~      This study will further investigate the upgraded (connected to a cloud server via an~     integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit~     mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification~     system.~   "
30192|NCT02661906|"~     The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has~     effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.~   "
30193|NCT02661893|"~     The purpose of this study is to assess the effect of single- and multiple-dose of rifampin~     on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy~     male and female participants.~   "
30194|NCT02661880|"~     Current practice in larger palliative care centers offer many supportive service modalities,~     which are often unavailable in the rural setting. Music Therapy by experienced registered~     Music Therapists is an example of such a modality. The current evidence continues to grow,~     identifying Music Therapy's benefits to help with symptom relief as well as to improve~     Quality of Life in many aspects of medicine, but especially in the context of palliative~     care. This proposal outlines an initiative to provide music-based interventions in a rural~     community palliative care unit where there is limited availability to a registered Music~     Therapist.~   "
30195|NCT02661867|"~     Objective of this longitudinal observational cohort study was to analyze incidence of pelvic~     floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary~     incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two~     groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).~   "
30201|NCT02661789|"~     The project aimed at identifying neuropsychobiological signatures of pharmacological~     sex-steroid hormone manipulations in healthy women as a risk model for depression.~      The study is a double-blind, randomized, placebo-controlled study. Investigators included 63~     healthy female volunteers with regular menstrual cycles between 23 and 35 days. Participants~     were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg~     implant) or placebo (saline injection) intervention, which was initiated in the mid~     follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the~     analyses, except for a few drop outs on some domains. The following domains were addressed~     at baseline and at follow-up (16±3 days post intervention), (which corresponded to the early~     ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin~     transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional~     Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating~     state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7)~     Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of~     immunoactive cell responses, 9) Epigenetic factors.~      Psychometrics in terms of self reported mental distress and interview based ratings were~     monitored across the intervention period to monitor potential symptoms of mental distress~     and psychopathology. Also ovarian hormone responses, peripheral blood markers, and side~     effects scores were collected across the intervention period.~   "
30202|NCT02661776|"~     Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical~     procedures significantly reduces the immune function in proportion to the degree of tissue~     injury. In addition, the use of opioids as analgesics during the perioperative period~     depress cellular immunity, in particular the activity of the natural killer (NK) cells. This~     perioperative immunosuppression may cause deleterious consequences on postoperative outcome~     in cancer patients. The aim of this study is to confirm the presence or extent of the change~     of NK cell activity between before and after head and neck surgery. Additionally,~     investigators will identify the clinical or genetic factors related to the change of NK cell~     activity.~   "
30203|NCT02661763|"~     This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia~     through school-based screening methodology using ultraportable echocardiography and a~     recently validated, abridged screening protocol based on World Heart Federation criteria.~     Children that screen positive for RHD at schools will undergo confirmatory evaluation at~     University Teaching Hospital (UTH), Lusaka's main referral hospital.~   "
30204|NCT02661750|"~     The purpose of this study is to document the safety and effectiveness of high doses of~     liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a~     poorly cleaned colon.~   "
30205|NCT02661737|"~     To evaluate long-term safety of YVOIRE volumes by incidence of adverse events including~     injection site local reactions and biodegradability.~   "
30206|NCT02661724|"~     Persons with burn-related pain remain under treated and do not have access to comprehensive~     burn pain management. We seek to extend evidence-based cognitive behavioral pain management~     strategies to a group of burn survivors that are currently under treated for for burn pain~     with a specific goal of reducing pain related interference in life activities.~      Investigators will conduct a randomized controlled trial to test the central hypothesis that~     a computer-based cognitive-behavioral program (Take Charge of Burn Pain) will improve pain~     management, psychological health, and improve participation in burn survivors. Specific aims~     include: 1) to determine the efficacy of a web-based self-management intervention in~     reducing pain and pain-related interference and increasing pain management self-efficacy;~     and 2) to determine whether Take Charge of Burn Pain improves psychological health and~     participation in life activities in persons with burn injury pain. Emerging research~     suggests that web-based pain management interventions may be a feasible and effective~     alternative to clinic-based interventions for patients with mobility and geographic~     restrictions, such as those treated at tertiary burn centers.~   "
30207|NCT02661711|"~     The purpose of this study is to assess the safety and efficacy of intravitreal injections of~     Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying~     Retinitis Pigmentosa (RP).~   "
30208|NCT02661698|"~     This study will evaluate the absorption of two different dietary supplements containing the~     omega 3 fatty acids eicosapentaenoic acid and docosahexaenoic acid over 24 hours via venous~     blood plasma following a single dose taken at bed time. In addition, the circadian rhythm of~     fatty acid metabolism will also be assessed following the placebo intervention.~   "
30209|NCT02661685|"~     The purpose of this study is to determine the safety of adoptive transferring autologous~     IKDC-like cells~   "
30210|NCT02661672|"~     Objective: The primary objective of this multicenter prospective registry is to provide~     additional safety, technical outcomes and clinical outcomes data for minimally invasive~     endoscopic surgery (MIES) with Apollo for the evacuation of supratentorial brain hemorrhage~     in adult patients who do not qualify for the concurrent INVEST randomized controlled trial~     at active INVEST centers.~   "
30211|NCT02661659|"~     A phase Ib study investigating the safety, the immunogenicity and the optimal administration~     frequency of the S-588210 5-peptide vaccine in MPM patients without progression after~     pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate~     predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and~     post-vaccination will be performed in blood samples of patients treated with the vaccine.~     Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with~     induction of antigen-specific T-cell responses. Finally, to explore the infiltration of~     tumors with T-cells and the potential presence of an immunosuppressive tumor~     microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4)~     and immune suppressive cell subsets (T-regs, macrophages) will be performed.~   "
30212|NCT02661646|"~     Assessment of QOL and symptoms changes in primary or secondary, unilateral or bilateral~     lower extremity patients using an advanced pneumatic compression system.~   "
30213|NCT02661633|"~     This study is designed to collect data which will be used to correlate changes in EEG to~     mild TBI in sports concussion.~   "
30491|NCT02657993|"~     The purpose of this study is to determine whether hypnosis is efficacious in reducing~     musculoskeletal pain in breast cancer survivors taking aromatase inhibitors, and by doing~     so, whether hypnosis can help survivors to be more adherent to their medication regimen.~   "
30214|NCT02661620|"~     A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a~     post-market, retrospective-prospective, multi-center, single arm, consecutive series study~     design to provide data on the post market performance and safety of the study device. The~     study will collect retrospective data from medical records review and prospective data from~     observations data at 5 and 10 postoperatively clinical visits. There will also be a 7 year~     telephone follow up contact to assess for device status and adverse events.~   "
30215|NCT02661607|"~     A prospective study to compare the use of point of care echocardiography versus routine~     chest radiography for the assessment of central venous catheter placement.~   "
30216|NCT02661594|"~     Randomised, single-dose, crossover, placebo-controlled study to see if intravenous~     amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy~     adult volunteers.~   "
30217|NCT02661581|"~     PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve~     and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...)~     achieved from previous short-term diabetes education program. Our goal is to provide a new~     generation of education and support that can be ongoing, patient-driven, and flexible to the~     dynamic and evolving conditions of patients' real-word environment and life circumstances.~   "
30218|NCT02661568|"~     This study will utilize a retrospective cohort design. Using the Clinical Practice Research~     Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a~     record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and~     followed from the occurrence of VTE (index date) to the first of 24 months after the index~     date, end of the study period, leaving the database, or death.~   "
30219|NCT02661555|"~     The purpose of the project is to investigate how aerobic exercise affects brain volume,~     specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.~      The study will be a single blinded randomized controlled trial with a 6 months intervention.~      It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of~     hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in~     people with multiple sclerosis.~   "
30220|NCT02661542|"~     A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors~     and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the MTD.~     Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer.~     Cohort 2 will include subjects with another tumor type enrolled in the Phase 1~     dose-escalation phase who have demonstrated Clinical Benefit by Week 16.~   "
30221|NCT02661529|"~     The study aims to answer whether the use of a mixture of blood and saline alone (limited~     air) provides the same degree of right-heart contrast enhancement as compared to the~     standard agitated saline (with air), during two types of echocardiograms.~   "
30222|NCT02661516|"~     The purpose of the study is to estimate the impact of bleeding events in patients in the UK~     with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).~   "
30223|NCT02661503|"~     Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of~     BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to~     PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy~     objective).~      If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate~     reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment~     measured by treatment related morbidity (TRMorbidity objective).~   "
30224|NCT02661490|"~     The purpose of this study is to further develop a formulation and dose regimen of the~     norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe~     in an elderly population aged 60 years and above.~   "
30225|NCT02661477|"~     The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to~     eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with~     hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary~     complications. Pegylated interferon alpha with ribavirin appear to effectively clear~     persistent rhinovirus infections in hypogammaglobulinemia patients.~      Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection~     will be randomly assigned in a double-blind fashion to receive either~        -  Group 1: subcutaneous pIFNα2a~        -  Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and~          at 2-month after entry to study. In addition, possible bacterial infections will be~          treated with antibiotics. Each patient will be followed with weekly nasal surveillance~          samples for 2 months and a symptom diary. Blood draws take place at study entry, 1-week~          and 2-month time-points.~   "
30226|NCT02661464|"~     The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and~     MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3~     clinical studies.~   "
30227|NCT02661451|"~     The objective of this study is to determine the safety and efficacy of transcatheter aortic~     valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as~     compared with OHFT.~   "
30228|NCT02661438|"~     The rationale of this study is to conduct a summative (i.e., validation) usability test of~     Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.~   "
30229|NCT02661425|"~     This is a retrospective study designed to gather outcomes data from existing medical charts~     from patients who have taken EnteraGam for management of their IBS-D for at least eight~     weeks. Data from two study periods will be collected: (1) the time during which the Standard~     of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or~     non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the~     time during which EnteraGam is used as therapy.~   "
30241|NCT02661269|"~     Can videomicroscopy of the sublingual microcirculation detect the increase in edema before~     peripheral edema will appear? By measuring the decrease in vesseldensity after strong~     positive fluid balances within septic patients versus euvolemic post-cardiac surgery~     patients. Measuring reactance and resistance (BIVA method) to determine volume status.~      Primary outcome:~      - Total vessel density (TVD)~      Secondary outcome:~        -  Fluid balance~        -  BIVA measurements (reactance & resistance)~   "
44811|NCT02470468|"~     The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune~     enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression~     free survival (PFS).~   "
30230|NCT02661412|"~     Since its introduction in the late 1990s, immediate implant loading concepts (IL) have~     become a frequent alternative for delayed implant procedures. IL concepts reduce chair time,~     the number of surgical interventions and pain, and offer instant comfort to the patient. Its~     reduced treatment time results in obvious socioeconomic advantages. Although there is at~     present abundant evidence that supports IL, evaluation of long-term biological and~     mechanical stability outcomes of large patient populations could allow quality improvement~     and more accurate patient selection. The Departments of Oral and Maxillofacial Surgery and~     the Department of Dentistry of the General Hospital Saint-John Bruges act as one of the~     pioneers of IL in Belgium, routinely performing the concept since 2001.~      The investigators aim to evaluate the biological and mechanical short- and long-term outcome~     of IL in partially or completely edentulous patients. Moreover, the investigators aim to~     detect potential influencing risk factors predicting undesirable prosthetic outcome.~   "
30231|NCT02661399|"~     The investigators are doing a research study that will teach us about the tingly pain that~     people develop when they get chemotherapy.~   "
30232|NCT02661386|"~     1. An intact pharyngoesophageal reflex is essential to protect the upper airway from~          aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is~          essential at protecting the airway in all patients.~        2. In patients, while under general anesthesia, it is postulated that an identifiable~          upper esophageal sphincter and esophageal peristalsis are not present.~        3. With the cessation of general anesthetics, accompanied by the reversal of nerve block,~          normal pharyngoesophageal peristaltic activity correlates with awakening the patient~          from anesthesia. This would be identified by the performance of esophageal manometry.~        4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence~          accurately identifies a safe time to remove endotracheal tubes and/or reverse~          anesthesia. This verbally stimulated swallowing sequence correlated precisely with the~          return of objective pharyngoesophageal function.~   "
30233|NCT02661373|"~     Malaria is an infectious disease caused by a parasite that is passed to humans when an~     infected mosquito bites a person. About 3.4 billion people live in areas of the world where~     malaria is regularly found. In many countries, malaria is one of the leading causes of~     illness and death. Despite this, there are a limited number of drugs, called antimalarials,~     that can be used to treat malaria and increasing reports of resistance to existing~     antimalarials..~      The purpose of this research study is to test a new experimental antimalarial drug called~     SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.~      PRIMARY OBJECTIVES:~        -  To assess the preliminary safety and tolerability of escalating doses of antimalarial~          SJ733 in healthy human volunteers.~        -  To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial~          SJ733 and its metabolite in healthy human volunteers.~        -  To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria~          challenge study.~      SECONDARY OBJECTIVE:~        -  To assess the impact of food intake on the pharmacokinetic profile of antimalarial~          SJ733.~   "
30234|NCT02661360|"~     The purpose of this randomized, within-subject, cross-over study is to examine if swaddling~     affects bottle feeding performance in infants born preterm. Results from research will have~     implication on neurobehavioral and physiologic outcomes as important indicators for the~     possible effect of swaddling during bottle feeding.~   "
30235|NCT02661347|"~     The purpose of this study is to test the efficacy of transcranial direct current stimulation~     (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone~     treatment who are experiencing recent onset psychosis.~   "
30236|NCT02661334|"~     The purpose of this study is to compare the physical fitness performance—as measured by the~     Air Force Physical Fitness Test (PFT)—of subjects that, in conjunction with exercise, will~     take creatine supplementation over a four week period versus those that do not.~   "
30237|NCT02661321|"~     This was an observational pilot study to examine the usefulness of an electronic sensor that~     monitors short-acting beta-agonist inhaled medication use. The goals of this study were to:~     1) test the feasibility of using the inhaler sensor to measure worsening symptoms and~     exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine~     whether environmental factors can be linked to mild exacerbations measured by the inhaler~     sensor.~   "
30238|NCT02661308|"~     The main purpose of this interdisciplinary proposal is to conduct two randomized controlled~     trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White~     Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related~     fatigue. Another common and often overlapping treatment side-effect is cognitive impairment.~     A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible~     underlying chronobiological (circadian activity rhythms, sleep), biological (pro~     inflammatory markers), and neurophysiological (brain morphology) mechanisms of BWL will be~     explored.~   "
30239|NCT02661295|"~     The risk of cardiovascular mortality in patients with end stage renal disease on~     hemodialysis is 10-100 times higher than the normal population. This is due in part to high~     levels of inflammation and vascular calcification found in these patients. Phosphate~     binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk~     by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based~     phosphate binder with approximately 210 mg of ferric iron has recently been approved for~     patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid~     levels is unknown but investigators hypothesize that ferric citrate has the potential to~     improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous~     iron requirements and by improving lipid metabolism.~   "
30240|NCT02661282|"~     The goal of Phase I of this clinical research study is to find the highest tolerable dose of~     cytomegalovirus cytotoxic T lymphocytes (CMV CTLs) that can be given in combination with~     temozolomide to patients with glioblastoma.~      The goal of Phase II of this study is to learn if CMV CTLs combined with temozolomide can~     help to control glioblastoma. The safety of this combination will also be studied.~   "
30274|NCT02660840|"~     To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and~     5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg~     flupentixol, administered as single doses~   "
44812|NCT02470455|"~     The study was conducted to find out any possible effect of Atorvastatin on glycemic~     parameters in prediabetic patients.~   "
30242|NCT02661256|"~     Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a~     common practice in many neonatal intensive care units (NICU) all over the country. However~     the safety of such practice has never been established. The Investigators hypothesize that~     mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered~     by the reception of pressurized airflow provided by the NCPAP, hence increase risk of~     aspiration. In this study, changes in the pharyngeal phase of swallowing were identified~     using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to~     off NCPAP.~   "
30243|NCT02661243|"~     Until now it has not been investigated whether placement of implants in SS patients is less~     successful than compared to non-SS patients. The risk factors and the efficacy of dental~     implants in dry mouth patients are not known because of the lack of scientific evidence. The~     aim of this study is to investigate changes in marginal peri-implant bone loss and the~     clinical performance of dental implants in SS patients compared to implants in healthy~     patients.~   "
30244|NCT02661230|"~     This project proposes the development and design of a motor intervention using a cognitive~     video game and describes the feasibility, safety and acceptability of virtual augmented~     video gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in~     two phases is performed in healthy participants (Phase 1) and heart patients after elective~     heart surgery on the Intensive Care Unit (Phase 2).~      Furthermore, brain function will be measured during exer-gaming with the VRICU device with~     non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart~     patients.~      The VRICU device is a patient friendly construction to allow a patient exergaming in bed.~     The project is a cooperation between scientist at the USZ (physiotherapist /~     anaesthsiologists / engineers), human movement scientist at the ETHZ and (poly- / electro-)~     mechanics at the Paul Scherrer Institut.~   "
30245|NCT02661217|"~     To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with~     LCZ696 in HFrEF patients following stabilization after an ADHF episode.~   "
30246|NCT02661204|"~     The purpose of this study is to evaluate the diagnostic performance of a new ABUS system~     among 4 different population:~      Population A: women undergoing screening for familial or genetic predisposition for breast~     cancer.~      Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to~     breast MRI in the pre-operative assessment of breast cancer extent.~      Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination.~     ABUS will be evaluate as a problem-solving tool.~      Population D: women undergoing breast MRI for the assessment of breast implants integrity.~     ABUS performance will be compared to breast MRI.~   "
30247|NCT02661191|"~     The study aim is in two phases. First phase: to evaluate the influence of vitamin D~     deficiency on asthma severity, degree of airway obstruction and frequency of asthma~     exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH~     vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease~     exacerbations.~   "
30248|NCT02661178|"~     This study will investigate the safety, tolerability, and pharmacokinetics of single~     ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also~     conduct an exploratory investigation of the relative bioavailability of emodepside~     administered as tablets.~   "
30249|NCT02661165|"~     This exploratory study is researching how the spirituality of a group of British patients~     with type 2 diabetes (T2D), impacts their approach to the self-management of their~     condition.~      Bio-statistical markers will be taken from consenting participants' Clinic database records.~     Qualitative interviews will be conducted with participants, and the results analysed and~     interpreted, alongside their bio-statistical markers.~      Results will be presented in healthcare peer reviewed journals and conferences, to inform~     clinicians how patients' self-management of their T2D is influenced by their spirituality.~   "
30250|NCT02661152|"~     Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase~     radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).~      In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously~     been possible to discriminate more hypoxic tumours from less hypoxic tumours.~      A hypoxia gene profile has shown to discriminate between responders and non-responders to~     nimorazole.~      In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/-~     nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in~     selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.~   "
30251|NCT02661139|"~     The number of patients requiring major ablative surgery in the oral cavity, including~     partial/radical mandibular or maxillary resection, due to a head and neck carcinoma,~     osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not~     been accurately reported. Surgical reconstruction to restore oral function and aesthetics~     forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life~     (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial~     Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General~     Hospital Saint-John Bruges led to the development of the Oncology-bridge (O-bridge)~     protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of~     sessions and a strongly reduced two-week treatment time, consequently accelerating patient'~     improved QOL at a considerably reduced cost.~      The investigators aim to develop a prospective database in which patient demographics,~     surgical, dental, prosthetic and QOL parameters collected during consecutive visits within~     the framework of routine practice, are being registered for each oncological patient~     eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity~     reconstruction This could provide the investigators with more information about potential~     patient, surgical and prosthetic factors influencing short- and long-term biological and~     mechanical stability, as well as patient QOL. Moreover, registration of those results could~     function as a measurement of quality of care, and could be used for sample size calculation~     for future large prospective trials.~   "
30252|NCT02661126|"~     The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of~     MK-3682B [MK-3682/grazoprevir (MK-5172)/ruzasvir (MK-8408) fixed dose combination (FDC)] in~     participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to healthy~     participants.~   "
30253|NCT02661113|"~     Phase II:~      Primary Objectives:~      -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of~     concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant~     temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM)~     as measured by overall survival.~      Secondary Objectives:~        -  To determine the efficacy of this treatment as measured by radiographic response (RR),~          progression-free survival (PFS) and time to progression (TTP).~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with RT and~          concomitant TMZ in patients with newly-diagnosed GBM.~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant~          TMZ in patients with GBM after RT.~      Exploratory Objectives:~      -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src,~     EphA2, c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and~     temozolomide.~   "
30254|NCT02661100|"~     This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL,~     and Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental~     cancer drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor~     agonist tumor specific antigens which when combined with Pembrolizumab may increase the~     tumor response to this drug.~   "
30255|NCT02661087|"~     Since the development in the last few years of the bipolar energy in the surgery by~     hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed~     by use of either monopolar or bipolar current.~      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective~     data on the adhesion rate and fertility after the use of bipolar energy during the surgery~     are poor, and there is currently no recommendation as to the choice of technique to use. The~     main purpose of this study is to compare the rate of uterine adhesions six weeks after the~     surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar~     energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.~   "
30256|NCT02661074|"~     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them~     are recognized as zoonotic agents, and have a high impact on human health.~      Infestation results from the ingestion of living larvae from contaminated fishes. It can be~     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.~     Allergic manifestations are frequently encountered in gastric forms, but isolated allergic~     symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous~     contact or Anisakis allergen inhalation have also been reported to induce~     allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy,~     Sicilia or South Africa. But no data is available in France.~      In this context, the investigators propose to determine and compare the frequency and~     characteristics of fish allergy in fish workers (fishermen and fish-processing factory~     workers) and a control population of workers without occupational exposure to fish, in~     Boulogne-sur-Mer, which is an important fishing port in France, and the first European~     center for fish processing.~   "
30257|NCT02661061|"~     Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for~     depression relapse prevention in persons at high risk. The main purpose of the pilot study~     is to assess trial processes to help inform a future definitive trial.~   "
30258|NCT02661048|"~     The objective of this clinical investigation is to evaluate the safety and efficacy of the~     CyberHeart System in patients with refractory ventricular tachycardia (VT).~      The ablation will be performed with the CyberHeart System and will target the anatomical~     site of the clinically presenting VT, using standard radiosurgery techniques.~      Cardiac radiosurgery is a minimally-non invasive, painless, procedure. Tissue ablation can~     be accomplished precisely.~   "
30259|NCT02661035|"~     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body~     irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell~     infusion. The primary objective is to evaluate rates of acute graft-versus-host disease~     (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and~     mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with~     hematologic malignancies.~   "
30260|NCT02661022|"~     A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone~     In Relapsed and Refractory Multiple Myeloma~   "
30261|NCT02661009|"~     In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung~     cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth~     Factor Receptor) mutations. By the following two aspects, investigators evaluate the~     clinical performance of the EGFR quantitative kits.~        1. methodology validation: To certify the equivalence between the EGFR quantitative kit~          and the common used detection methods.~        2. analysis of the relationship between the type and proportion of EGFR sensitive mutation~          and EGFR-TKI benefit.~   "
30262|NCT02660996|"~     The objective of this observational study is to assess the effectiveness of the Advocate~     Lutheran General Survivorship Center's Programs by measuring the following outcomes of~     interest on participating patients:~        1. Quality of life~        2. Distress level~        3. Satisfaction with the Survivorship Program~      General Hypothesis: Patients who participate in at least four classes in a two month period~     will have higher scores on the post-class satisfaction, quality of life, and distress~     surveys compared to their pre-class surveys.~   "
30263|NCT02660983|"~     The primary objectives are to confirm that donepezil hydrochloride has superior efficacy in~     improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive~     subscale (ADAS-cog), and to demonstrate that donepezil hydrochloride has superior efficacy~     in improving global function, as measured by Clinician's Interview-Based Impression of~     Change-plus Caregiver Input (CIBIC-plus), compared with placebo in patients with dementia~     associated with cerebrovascular disease (VaD)~   "
30275|NCT02660827|"~     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric~     subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to~     demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe~     as part of the overall system.~   "
30276|NCT02660814|"~     The objective in this case-control intervention study, therefore, was to explore the effect~     of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with~     chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and~     prognostic biomarker of periodontal disease.~   "
30264|NCT02660970|"~     Functional gastrointestinal disorders are common disorders that are characterized by~     persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the~     GI tract and are not caused by structural or biochemical abnormalities. As a result, medical~     tests- such as blood tests and endoscopic exams- have essentially normal/negative~     (non-disease) results. More than 20 functional GI disorders have been identified. They can~     affect any part of the GI tract. One of the most common functional disorders is nausea and~     dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).~     Any chronic illness, including functional nausea, will affect a person's health-related~     quality of life (general well-being, ability to carry out everyday activities), additional~     psychosocial disturbances and amplify the experienced illness.~      The majority of children suffering from functional nausea in Europe are treated with~     Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since~     Iberogast® is not available in the United States of America, children there receive an~     acupressure therapy. The American gastroenterologists refer hereby to several studies, which~     have shown, that the positive effect of such therapies in patients with chemotherapy-induced~     nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce~     somatic nausea, it is also believed to decrease functional nausea, but it has never been~     investigated. Therefore, there are no data. That's why Investigators want to compare the~     efficacy of these two therapies, that is, Iberogast® and acupressure~   "
30265|NCT02660957|"~     The purpose of this study is to test the effectiveness of using a brief, self-determination~     intervention on smoking cessation (immediate or progressive) for people attending AEDs.~   "
30266|NCT02660944|"~     This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the~     cutaneous manifestations in subjects with systemic lupus erythematosus.~   "
30267|NCT02660931|"~     This proposal will incorporate statistical models developed by the investigators to predict~     risk for acute kidney injury into our electronic medical record system, enabling an alert to~     notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in~     the intervention group, for whom the notification will be implemented, or in the control~     group, who will receive usual care (no notification). The investigators believe the~     notification will increase appropriate screening for acute kidney injury and reduce the~     severity of acute kidney injury in the intervention group.~   "
30268|NCT02660918|"~     To determine whether paracervical injection of long acting local anesthesia decreases~     postoperative pain following endometrial ablation under general anesthesia.~   "
30269|NCT02660905|"~     This is an prospective open label pilot study conducted over 32 weeks.~      A total of 25 eligible participants who are infected with HCV and HIV will be recruited from~     2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill~     University Health Centre)~      This study is looking into the effectiveness of a combination of~     Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen~     (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment .~      This study will assess the effect that the study drug has on the metabolism of sugar, the~     changes in fat in the bloodstream and other metabolic changes. Metabolism is the process~     your body uses to get or make energy from the food you eat.~      This study may provide information on the impact of liver fibrosis (scarring of liver~     tissues) on metabolic changes before, during and after HCV antiviral therapy.~      Drug-drug interactions (DDI) DDI between E/C/F/TAF and LPV-SOF have been well evaluated and~     no clinically significant interactions have been identified.~      A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be~     particularly beneficial because of its:~        1. favorable side effect profile~        2. once daily STR formulation~        3. known DDI profile with LPV-SOF~        4. neutral effect on liver fibrosis~        5. improved kidney and bone safety profile with the use of TAF~      Conduct of this study is justified as it:~        1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and~          HCV using well tolerated medications with an excellent safety profile and known DDI~          profile.~        2. Provides additional safety data for TAF in the HIV-HCV co-infected population.~        3. Quantifies adherence and identifies obstacles to full adherence in this population.~          There is a paucity of data related to DAA adherence in licensing studies.~        4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF~          DAA therapy in HIV-HCV co-infected populations.~        5. Provides preliminary data on the immunologic and metabolic consequences of HCV~          clearance in HIV-HCV co-infection~        6. As a pilot study, the information gathered will inform the feasibility of future~          clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.~   "
30270|NCT02660892|"~     Threonine is an indispensable amino acid, which is required for human growth and protein~     synthesis. Deficiency in threonine can affect small intestine growth due to its structural~     importance in the intestinal protein mucin. While Threonine is found in many foods,~     deficiency can occur in developing countries where nutrition is primarily plant based, and~     low in available protein. Ensuring that the dietary intake is sufficient to meet the minimum~     threshold for growth and development is important for population health. Using a new~     technique called Indicator Amino Acid Oxidation (IAAO), threonine requirements will be~     determined in school-aged children (6-10y). The study will help to determine the minimum~     amount of threonine that is needed to ensure that dietary recommended guidelines are~     sufficient to meet the needs of this population. Current dietary recommended intake is 19~     mg/kg-d in this population, but is based on factorial calculations.~      Secondary aims will determine the metabolic availability of threonine from food. Protein~     isolate from food sources (Casein, Soy protein, Pea protein) will be used to provide~     threonine in place of crystalline amino acids. The IAAO method will be used to determine the~     amount of oxidation that occurs with known quantities of threonine in food compared to~     crystalline amino acids, which are regarded as being 100% available.~      The investigators hypothesize that the threonine requirement in healthy children will be~     higher than the current dietary recommendation of 19 mg/kg-d. Investigators also hypothesize~     that Casein will have a higher metabolic availability than either Soy protein isolate, or~     Pea protein isolate.~   "
30271|NCT02660879|"~     The investigators looked at the effect that video instruction located at www.useinhalers.com~     would have on improving inhaler technique at a hospital in Guayaquil, Ecuador. The~     investigators compared this video instruction to written Spanish inhaler education. The~     investigators video taped participants before and after the intervention, and graded their~     technique on a pre-defined rubric.~   "
30272|NCT02660866|"~     This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08~     mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to~     patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC)~     treated with standard medical therapy (SMT) would lead to an improvement in the peak walking~     time (PWT).~   "
30273|NCT02660853|"~     The purpose of this study is to investigate exacerbations in severe asthma with regard to~     symptoms, lung function, aetiology and biomarkers.~   "
30278|NCT02660788|"~     A randomized, double-blinded study conducted in British Columbia, Canada, where there is a~     publicly funded, organized screening program and screening mammography is recommended at~     24-month intervals. Eligible women aged 51-73 years old and overdue for their screening~     mammogram by 6-24 months are identified in the database of the Screening Mammography Program~     of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the~     overdue women in their practices. The overdue women are randomized and mailed either the~     signed reminder letter and the standard reminder postcard, or the standard reminder postcard~     alone. The primary endpoint is the proportion of overdue women attending a screening~     mammogram appointment 6 months after the mailing.~   "
30279|NCT02660775|"~     In people with schizophrenia or people with autism, impairments of social cognition are a~     core feature of the disease and, according to researchers who represent valuable references~     on this subject for the international community, three to five processes of social cognition~     are usually altered in those diseases: (1) emotional processing which is the ability to~     identify emotions through facial expressions, gestures, and tone of voice, (2) theory of~     mind (ToM), which is defined as the ability to attribute mental states (beliefs, intents,~     desires, …) to oneself and others, and to understand that others have beliefs, intentions,~     and desires that are different from one's own, (3) attributional style which refers to how~     people explain the causes of positive and negative events, and corresponding, in~     schizophrenia, to self-serving and personalizing bias that means a tendency to blame others~     for negative life events rather than sharing the responsibilities between different sources;~     and (4 and 5) social perception and knowledge, which can be defined as decoding and~     interpreting social cues from others, taking the social context into account, and knowing~     social rules, roles, and goals. Components of social cognition appear to be related to both~     symptomatology and functioning in everyday life. The present study aims to assess a new~     social cognitive battery developed by several teams in France: ClaCoS.~   "
30280|NCT02660762|"~     This prospective study was conducted to evaluate the efficacy and safety profiles of~     Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk,~     Philadelphia chromosome negative acute lymphoblastic leukaemia.~   "
30281|NCT02660749|"~     Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative~     period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and~     character has been seen in the chronic phase targeted.~   "
30282|NCT02660736|"~     Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed~     and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized~     albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen~     injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will~     enable the use of a liquid product in a ready-to-use single dose auto-injector. To support~     the development of the liquid auto-injector product, this healthy volunteer bioequivalence~     study will be conducted to compare the liquid drug product to the currently available~     lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,~     2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics~     and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg~     commercial lyophilized drug product.~   "
30283|NCT02660723|"~     The main goal of this study is to investigate the impact of aging on the responsiveness of~     peripheral blood immune cells. To this aim, the investigators will take advantage of a~     recently described syringe-based assay system that can reproducibly assess induced, innate~     or adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to~     this study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A~     total of 14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing~     poly(I:C), R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at~     37°C, cellular supernatants will assessed for levels of 10 different chemokines using a~     MesoScaleDiscovery multiplexing platform.~   "
30284|NCT02660710|"~     The purpose of this study is to establish the safety of rituximab plus cyclophosphamide,~     doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse~     large B-cell lymphoma (DLBCL) patients in Malawi.~   "
30285|NCT02660697|"~     The present retrospective study aims at assessing the clinical effects of a novel implant~     site development (Extraction site development - XSD) technique after tooth extraction~     compared with extraction alone in patients requiring dental implant placement following~     healing of extraction sockets.~   "
30286|NCT02660684|"~     The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf~     capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in~     patients who received peripheral hematopoietic stem cell transplantation from a sibling~     donor, and to compare with data from a historical control group that administered a~     conventional Cyclosporine formulation.~   "
30287|NCT02660671|"~     This is an RCT aimed at testing different population-based approaches to increasing~     colorectal cancer screening through email outreach, including usual email communication,~     active choice, and active choice + financial incentive.~   "
30288|NCT02660658|"~     Spinal anesthesia is a commonly used technique for lower limb surgeries offering better~     quality of postoperative analgesia, lower incidence of side effects, and shorter~     post-anesthesia care unit stay than general anesthesia. However, the relatively short~     duration of action of the currently available local anesthetics (LAs) make these advantages~     short-lived.~      The risk for local anesthetic toxicity (LAST) increases with the trials to use higher~     concentrations or volumes of intrathecal local anesthetics to increase the duration of~     analgesia.~      Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without~     the need for using high doses of local anesthetics and hence with decreasing the potential~     risk of local anesthetic, but the increased likelihood adverse effects such as short term~     bradycardia and prolonged duration of motor block may offset these benefits.~   "
30289|NCT02660645|"~     Registry study to gather more information on the current use of Blue Light Cystoscopy with~     Cysview (BLCC) in urologists' practices.~   "
30359|NCT02659722|"~     The primary objective of this prospective, post-market study is to collect data to assess~     the long term outcome of a broad contact modular interbody device in the form of the~     InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for~     degenerative disc disease and/or scoliosis. Comparisons will be made with published~     historical data..~   "
30290|NCT02660632|"~     Pulmonary complications are among the most important postoperative complications after~     midline incisions, for which different analgesic modalities have been tried.~      Epidural analgesia is the recommended technique to relieve pain after major abdominal~     surgery owing to the proved superior analgesia, reduction of opioid related side effects as~     nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier~     ability for postoperative mobility However, it is not without complications.~      Rectus sheath block provides several advantages over epidural anesthesia. It lessens the~     potential risks associated with neuraxial techniques, so it may represent a novel~     alternative approach for somatic analgesia after major abdominal surgeries. Although~     patients with rectus sheath block may experience some visceral pain, it is usually minimal~     by 24 hours after surgery.~   "
30291|NCT02660619|"~     The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance~     use disorder.~   "
30292|NCT02660606|"~     The purpose of this study is to evaluate the patient usability and reliability of the POMAQ~     survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe~     pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users~   "
30293|NCT02660593|"~     MedlinePlus related topics: Blood Sugar~      Primary Outcome Measures:~        -  Fast glucose and HbA1c change between the baseline and end of study [ Time Frame: From~          baseline to 30 and 100 days]~        -  [ Designated as safety issue: No ]~        -  Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [~          Time Frame: From baseline to 30 days and 100 days] [ Designated as safety issue: No ]~      Secondary Outcome Measures:~      • To evaluate the change of quality of life in the 1 months by the health questionnaire~     SF-36 [ Time Frame: From baseline to month 1 ] [ Designated as safety issue: No ]~   "
30294|NCT02660580|"~     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022~     and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.~   "
30295|NCT02660567|"~     The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is~     a randomized controlled, multi-centre study that aims to compare the incidence of post~     partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using~     Amr's maneuver with active management of the third stage versus active management alone~   "
30296|NCT02660554|"~     The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic~     strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in~     critically ill adults with pneumonia suspected to be caused by methicillin resistant~     staphylococcus aureus (MRSA). The investigators hypothesize that when automated PCR is used~     to guide antibiotic therapy, antibiotic exposure will be reduced in critically ill subjects~     with pneumonia.~   "
30297|NCT02660541|"~     This is a randomized, controlled, multi-centre, open-label phase IV study. A total of 40~     patients will be enrolled in this study. Patients will be randomly assigned to Betafoam® or~     Allevyn® Silver dressing for burn wounds after acute burn injury.~   "
30298|NCT02660528|"~     This proposed study sets out to examine the antidepressant effects of tocilizumab among~     patients with treatment-refractory major depression.~   "
30299|NCT02660515|"~     Open reduction and internal fixation of intra-articular distal radius fractures leads to~     better functional outcomes the first 6 months compared to non-operative treatment. However,~     some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically~     assisted removal of intra- articular fracture haematoma and debris may reduce pain and~     improve the functional outcomes following operative treatment of intra-articular distal~     radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence~     of associated ligamentous injuries can be assessed. Therefore the objective of this study is~     to compare the functional outcome of internal plate fixation with additional wrist~     arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult~     patients with displaced intra-articular distal radius fractures.~   "
30300|NCT02660502|"~     This is a double-blind, randomised, three period crossover phase 1 trial using automated~     8-hour euglycemic clamps in healthy Japanese subjects.~      Each subject will be randomly allocated to one out of nine sequences to receive either three~     single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single~     doses of BioChaperone insulin lispro on three separate dosing visits.~      The total trial maximum duration for a subject will be up to 10 weeks.~   "
30301|NCT02660489|"~     The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459,~     in preventing or attenuating the symptoms of an asthma exacerbation after rhinovirus~     infection. The study is a double blind, randomised trial in which half the subjects will~     receive OC459 and the other half placebo, before being inoculated with rhinovirus, that~     would normally induce a worsening of asthma symptoms i.e. an exacerbation.~   "
30302|NCT02660476|"~     QUDOS is a cross-sectional population study aiming to answer key questions about diabetes~     and its complications in Qatar as well as identify factors associated with the development~     and progression of diabetes complications.~   "
30303|NCT02660463|"~     The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary~     embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does~     not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are~     surgically accessible. Otherwise interventional therapy by means of pulmonary~     balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the~     patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital~     and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016~     all incident patients will be de-identified and included prospectively. Risk factors,~     outcome and treatment will be documented.~   "
30304|NCT02660450|"~     Current literature report 3 ways to prescribe and control aerobic training. Such models~     require comparison to determine if they really provide the same impact training in a~     prescription. The aim of this study is to compare the results of different methods of~     prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted~     by perceived effort (PSE) as well as psychological responses activation, and feel depending~     on the stimuli offered.~   "
30360|NCT02659709|"~     Develop smartphone- and tablet-based application (app) for participants with glaucoma,~     ocular hypertension and those at risk.~   "
30305|NCT02660437|"~     Investigators wish to identify a relationship between substantial changes in carbon dioxide~     partial-pressure (pCO2), which frequently occur during the transitions from rest to exercise~     (ΔpCO2 >4 millimeters of mercury [mmHg] from baseline), and the prevalence of cognitive~     dysfunction in COPD. In particular, it is anticipated to investigate the vascular effect of~     pCO2 oscillations in the regulation of cerebral blood flow (CBF) during exercise and its~     impact on cognitive function in Chronic Obstructive Pulmonary Disease (COPD). Furthermore,~     this study aims to examine whether major pCO2 oscillations have prognostic value in~     cognitive deterioration at 6, 12, and 18-month follow-up. In addition, the acute effect of~     3-week pulmonary rehabilitation (PR) on cognitive function will be explored. The evaluation~     of cognitive function will be performed by the use of Standardized Mini Mental State~     Examination (SMMSE), Addenbrooke's Cognitive Examination (ACE-R), Montreal Cognitive~     Assessment (MoCA), and Telephone Interview for Cognitive Status (TICS) assessing several~     cognitive domains (cognitive scores) whereas Stroop test [color reading interference] will~     be used for measuring cognitive performance (Reaction-Time).~   "
30306|NCT02660424|"~     The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment~     of osteoarthritis pain~   "
30307|NCT02660411|"~     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone~     with the ageing process, more and more elderly patients undergo surgery for malignant tumor.~     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous~     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From~     the point of view of immune function after surgery and invasiveness of malignant tumor~     cells, propofol intravenous anesthesia may be superior to inhalational anesthesia. However,~     the clinical significance of these effects remains unclear. Retrospective studies indicated~     that use of propofol intravenous anesthesia was associated higher long-term survival rate.~     Prospective studies exploring the effect of anesthetic choice on long-term survival in~     cancer surgery patients are urgently needed.~   "
30308|NCT02660398|"~     This prospective study will take place at Harborview Medical Center (HMC) and the University~     of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal~     surgery. The purpose of this study is to identify if the use of a specific plan to managing~     muscle relaxants will help decrease the risk of muscle weakness after general anesthesia~     with muscle relaxation in a population of patients undergoing abdominal surgery.~   "
30309|NCT02660385|"~     Chronic insomnia may contribute to the development and exacerbation of heart failure (HF),~     incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea,~     anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and~     subjective functional performance.~      The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia~     severity, sleep characteristics, daytime symptoms, and functional performance over twelve~     months among patients who have stable chronic HF and chronic insomnia. The effects of the~     treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be~     examined.~      A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive~     behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF~     self-management education.~      Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of~     sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete~     self-report measures of insomnia, sleep, symptoms, and functional performance. In addition~     the effects on symptoms and function over a period of one year.~   "
30310|NCT02660372|"~     The aim of this study is to show non-inferiority of two brands of simeticone in adult~     patients suffering from functional dyspepsia.~   "
30311|NCT02660359|"~     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of~     two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary~     incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due~     to spinal cord injury (SCI) or multiple sclerosis (MS).~   "
30312|NCT02660346|"~     Patients with MRSaB have high therapeutic failure rates and mortality rates. Recent studies~     have shown that an elevated IL-10 level is an independent risk factor of mortality. It may~     also serve as biomarker for very early risk stratification. The aim of this study is to~     compare the outcomes for patients with elevated IL-10 levels (≥8 pg/ml) when treated with~     standard antibiotic therapy (daptomycin or vancomycin) versus early aggressive therapy~     (daptomycin with ceftaroline) for the treatment of MRSaB.~   "
30313|NCT02660333|"~     The purpose of this study is to evaluate the effect of prebiotic or synbiotic~     supplementation on inflammatory response and indicators of nutritional status in patients~     with morbid obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides~     (prebiotic) or 12 g/day of fructooligosaccharides + strains of lactobacilli and~     bifidobacteria (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute~     phase proteins, cytokines, metabolic and anthropometric parameters in individuals with BMI ≥~     40kg/m².~   "
30314|NCT02660320|"~     Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous~     epidermal cells suspension grafting versus dermabrasion using micro-needling technique +~     autologous epidermal cells suspension grafting and dermabrasion using micro-needling~     technique + placebo suspension grafting in stable vitiligo.~      A total of 10 patients with stable non-segmental vitiligo will be included in the ITT~     population.~      In each patient, three separate test areas will be selected in the same part of the body.~      One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension~     alone and the two others will receive the epidermal cell suspension in hyaluronic acid after~     pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his~     own control.~      Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week~     after cell grafting.~   "
30346|NCT02659891|"~     The overall goal of this study is to rapidly improve clearance of BK viremia with~     Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies~     in renal transplant recipients that have had immunosuppression reduction due to BK viremia.~     Our approach is to perform a prospective, randomized, placebo controlled trial intravenous~     immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus~     placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney~     transplantation.~   "
30315|NCT02660307|"~     This protocol proposes a well-being program based in stress reduction program for employees~     of a company.~      objectives: To evaluate the effects of a stress reduction program with a specific~     orientation for workers and taught to them within their companies.~      Methods: Participants with stress complaints were recruited and randomized into two groups:~     group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were~     evaluated before the intervention (time 1 - T1); again after the eight weeks of the program~     for G1 (time 2 - T2); and then at the end of a second eight-week period during which G2~     received the intervention and G1 was simply instructed to maintain the practice they had~     learned without further instruction (time 3- T3).~   "
30316|NCT02660294|"~     Successful embryo implantation needs an optimum embryonic development with a receptive~     endometrium. Endometrial thickness is an independant factor for endometrial receiptivity.~     The aim of that trial is to assess the benefecial effect of platelt rich plasma in~     copmarison with standard hormonal therapy.~   "
30317|NCT02660281|"~     This study will be a single-center treatment protocol, designed to validate the process of~     related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant~     Unit.~   "
30318|NCT02660268|"~     The main objective is to determine the contribution of a clinical pathway to improve the~     effectiveness of medico-surgical management of hip prosthesis infections in terms of~     clinical cure. The hypothesis raised is that the implementation of a clinical pathway would~     improve the performance of the medical and surgical management of chronic infections of~     prosthetic hip.~   "
30319|NCT02660255|"~     This is an observational, open-label, flexible dose study that will prospectively and~     longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with~     drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug~     protocol.~   "
30320|NCT02660242|"~     This project focuses on development of new strategy for the prevention of~     exercise-associated hypoglycemia using mini-dose glucagon.~   "
30321|NCT02660229|"~     The purpose of this study is to compare of difference in NRS scores from baseline to the~     completion of treatment (5 days) in patients taking morphine sulfate versus oxycodone~     hydrochloride.~   "
30322|NCT02660216|"~     Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The~     conventional approach is characterized by a vestibular incision extending from~     molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved~     chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an~     effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid~     bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro~     (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful~     disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary~     disjunction, the so-called Twist technique, to a minimally invasive protocol, performing~     the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision.~     Although promising, the technique remains highly sensitive from a technical standpoint, and~     its true accuracy has not been comprehensively evaluated.~      The purpose of this study is to present and validate a minimally invasive approach towards~     Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The~     primary outcome is to evaluate the accuracy of the technique using rigid voxel-based~     registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images.~     Secondary outcomes include the surgical time necessary to complete the procedure and the~     presence of intraoperative and early postoperative complications.~   "
30323|NCT02660203|"~     Following thoracic surgery, pleural effusion in pleural cavity requires post-operative~     drainage.~      Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation,~     lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.~     These complications could be avoided by respiratory physiotherapy.~      Forced expiration technic in ipsilateral decubitus is one of these technics but has never~     been proved better than other technics regarding its efficiency.~      The aim of the study is to compare the impact of such a technic on post operative thoracic~     drainage after pulmonary, pleural or mediastinal pediatric surgery.~   "
30324|NCT02660190|"~     Photodynamic diagnostic (PDD) is a technique where a photodynamic drug is installed~     preoperatively in the bladder. Mucosa cells with a higher metabolism than normal urothelial~     cells, e.g. cancer cells, absorbs this drug which is utilized during cystoscopy where blue~     light is absorbed by the drug, making the surgeon able to distinguish tumor cells from~     normal cells and thus being able to identify flat lesions and small papillomas missed in~     white light cystoscopy.~      The use of PDD at this primary transurethral resection of bladder tumour (TURB) has been~     shown to be associated with a lower recurrence rate within the first year, probably mostly~     owing to a higher detection rate of small papillomas and dysplasia that therefore can be~     relevantly treated at an early stage.~      Despite the use of PDD at the primary TURB, a high number of patients experience an early~     recurrence and patients with carcinoma in situ (CIS) treated with bacillus Calmette-Guerin~     (BCG) may have recurrence of their CIS or recurrence of papillomas despite the peroperative~     use of PDD.~      Whereas the use of PDD is well established in the TURB setting, the use of PDD in the~     follow-up setting with flexible cystoscopy in the outpatient clinic is not investigated.~     Feasibility studies have been successful but the clinical relevance and benefits have not~     been investigated so far.~      Thesis The thesis of the study is that the use of PDD in the outpatient clinic in patients~     with a high recurrence risk undergoing follow-up flexible cystoscopy will result in~     diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white~     light. Thus, a higher number of tumours can be treated in the outpatient setting without the~     need for procedures in general anesthesia. Furthermore, the number of follow-up cystoscopies~     can be reduced if PDD is used at the first cystoscopy following TURB.~      Aims To investigate whether the use of PDD when performing a flexible cystoscopy in the~     outpatient clinic can reduce the number of recurrences of large size papillomas that cannot~     be treated by simple fulguration without general anesthesia. Furthermore, to investigate~     whether the use of PDD in follow-up cystoscopy in patients with earlier complete response to~     BCG on CIS, can increase the detection rate of CIS recurrences.~   "
30325|NCT02660177|"~     This study aims to assess the PK parameters of metamizole following a single IV~     administration of metamizole in children less than 6 years of age.~   "
30326|NCT02660164|"~     The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the~     Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.~   "
30327|NCT02660151|"~     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal~     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,~     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal~     dystrophies as well as post-surgical conditions resulting from cataract extraction and~     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and~     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care~     professional.~      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if~     required.~   "
30329|NCT02660125|"~     Midluteal single endometrial strip will be taken using a Novak curett under general~     anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of~     forbidden cervix, the step that will be beneficial to embryo transfer procedure.~      Controller ovarian hyperstimulation; will be done using the long luteal phase agonist~     protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3~     FSH and antral follicular count and previous history of ovarian response).~      Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when~     there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval~     will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3~     after oocyt retrieval according to number and quality of embryos.~      Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test~     will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.~   "
30330|NCT02660112|"~     This 24-week study will test the safety and effectiveness of synthetically produced (+)~     Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.~   "
30331|NCT02660099|"~     The aim of this study is to test the feasibility and acceptability of an internet-delivered~     cognitive behavior therapy (ICBT) intervention originally developed for neurotypical~     adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism~     spectrum disorder (ASD). This feasibility study will inform us how to adapt the original~     intervention to the specific needs of patients with ASD.~   "
30332|NCT02660086|"~     This project tests a scalable and sustainable approach to weight gain prevention in a~     population of employees by using the worksite environment to deliver personalized feedback~     about worksite food purchases, daily calorie goals, social norms for healthy eating, and~     financial incentives for healthy food purchases. In the future, similar strategies could be~     adopted by other worksites, institutions, and food retailers and could contribute to the~     long-term environmental and social changes needed to reverse the obesity epidemic in the~     United States and worldwide.~   "
30333|NCT02660073|"~     Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian~     and military personnel in the United States. Spinal cord injuries (SCI) predispose~     individuals to impaired fitness, obesity, glucose intolerance and insulin resistance,~     placing them at greater risk for diabetes and coronary artery disease. These are devastating~     problems that occur frequently because of changes in body composition and reduced level of~     physical activity. Skeletal muscle wasting plays a central role in altered metabolism after~     SCI. Functional electrical stimulation (FES) is an effective rehabilitation tool that has~     been used to train the paralyzed skeletal muscles and which has shown some ability to~     ameliorate the deleterious effects of SCI on metabolism, particularly on insulin~     sensitivity. However, its ability to reverse skeletal muscle wasting is modest; most studies~     report limited gains in muscle mass and workload with highly variables outcomes from one~     study to another. This proposal was stimulated by the findings that a program of~     neuromuscular electrical stimulation resistance exercise prior to initiating functional~     electrical stimulation lower extremity cycling (FES-LEC) improves the gains in muscle mass~     and workload observed with FES. The specific objectives for the current proposal are to~     compare the impact of FES following evoking skeletal muscle hypertrophy of the lower~     extremity versus initiating FES cycling without introducing the hypertrophy effects on~     insulin sensitivity, control of blood sugar levels, oxygen uptake and amounts of muscle~     tissue and fat deposition. These studies could potentially have significant effects on~     thousands of people that will experience an SCI in the future as well as those living with~     SCI where prolonged paralysis is a major quality of life issue.~      There is a major need to investigate the mechanisms lead to maximize the benefits of FES~     applications and to understand cellular or molecular events that are associated with muscle~     hypertrophy and lead to promoting metabolic health after SCI. The designed study will~     provide a greater understanding regarding utilization of energy sources (like fats and~     sugars) in muscle~   "
30334|NCT02660060|"~     The present study was conducted to find out whether the bioavailability of 0.25 mg~     pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was~     equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH &~     Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).~   "
30335|NCT02660047|"~     Among South Asians, in comparison to Western Europeans, there is an increased risk of type 2~     diabetes mellitus (DM2) and DM2-related cardiovascular disease. The effect of Liraglutide~     (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of~     South Asian descent specifically.~      Liraglutide is a new widely prescribed therapeutic agent for DM2 patients. It is a Glucagon~     Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and~     body weight. The disadvantageous metabolic phenotype as seen in South Asians includes a~     relatively large total fat mass, with predominately visceral relative to subcutaneous~     adipose tissue and lower brown adipose tissue volume and activity, accompanied by increased~     lipid levels. The key elements in the mechanism of action of Liraglutide seem to correspond~     to the differences in metabolic profile between South Asians and Western Europeans.~     Diastolic dysfunction, an early finding of cardiovascular disease in DM2 and obesity and an~     independent predictor of mortality, has been shown to be associated with the amount of~     triglyceride accumulation in the heart and liver. The investigators hypothesize that~     Liraglutide has direct advantageous cardiovascular effects and reduces triglyceride~     accumulation in end-organs, specifically for DM2 patients of South Asian descent.~   "
30336|NCT02660034|"~     The Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody~     BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid~     Tumors~   "
30337|NCT02660021|"~     Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and~     face that are related to structure or growth malfunctioning, orthodontic problems, or~     co-morbidities associated with skeletal disfigurement.~      Imaging is crucial in the assessment and treatment planning of orthognathic surgery~     patients. Until recently, two-dimensional (2D) imaging, through cephalometry, was standard~     practice. However, it showed several limitations. The introduction of the cone-beam computed~     tomography (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift.~     Though widespread implementation in routine practice is not yet present. Our department is~     one of the pioneers in the world of 3D virtual treatment planning for orthognathic surgery.~     The triple CBCT scan procedure has been developed in-house and implemented already in~     2009.~      The investigators aim to develop a prospective database registering 3D treatment planning~     data of all consecutive patients eligible for orthognathic surgery, performed by Prof.~     Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and~     orthognathic surgery data are being collected during consecutive visits within the framework~     of routine practice.~      Development of a database registering 3D virtual treatment planning data of orthognathic~     surgery, will provide more information about potential patient, virtual planning and~     surgical factors influencing postoperative accuracy of jaw correction, long-term stability~     of the jawbone, long-term condylar resorption, or soft tissue response. In general, it could~     provide answers on research questions that have been examined in prior studies on~     2D-imaging, but can now be re-examined in case of 3D-imaging. Moreover, registration of~     those results could function as a measurement of quality of care, or could be used for~     sample size calculation for future large multicenter prospective trials.~   "
44813|NCT02470442|"~     The purpose of this study is to characterize the airway responses to desflurane during~     maintenance of and emergence from anesthesia in children whose airways were supported with~     laryngeal mask airways (LMAs).~   "
30339|NCT02659995|"~     Our multicenter prospective observational study aims to show the relationship between blood~     glucose levels and glycemic variability and the development of infections during the ICU~     stay and with outcome. Within the secondary endpoints, we will evaluate if a blood glucose~     range between 70 and 140 mg/dl is associated with an increasing surviving rate in~     non-diabetic critically ill patients.~      MATERIALS AND METHODS Multicenter study (ICUs of some Italian University Hospitals). Written~     informed consent will be request before the inclusion of each patient in the study; if it~     will not be possible, an informing module will be given to the patient's family and the~     informed consent will be request to the patients as soon as possible.~      Inclusion criteria: 300 patients consecutively admitted in each ICU from January 2016 and~     not later than 31/03/2017.~      Exclusion criteria: age < 18, end-stage disease. Data collection An Excel database will be~     edited with these data about each patient: age, sex, type I or II diabetes, glycated~     hemoglobin, at-home antidiabetic therapy; admission diagnosis, admission SAPS II score;~     daily insulin administration (dose and route of administration, time of start, dose at the~     moment of glycemic measurement and min-max daily range); steroid therapy (molecule, daily~     dose, date of start and stop); antibiotic therapy (molecule, daily dose, date of start and~     stop); daily caloric and protein intake and type of nutrition; other therapies; mechanical~     ventilation (date of start and stop); blood lactates (worst daily value); daily leucocytes~     and differential white cells count; daily SOFA score; presence of infections (suspected or~     confirmed; site and microorganism and eventual Multidrug Resistance pattern); presence of~     sepsis (following SCCM criteria); length of ICU and hospital stay; outcome (ICU and hospital~     mortality).~      Every blood glucose level measurement obtained will be registered with date and time.~      Glycemic variability will be evaluated in terms of:~        -  Standard deviation (SD)~        -  Mean Amplitude of Glycemic Excursions (MAGE);~        -  Coefficient of Variation (CV);~        -  Glycemic Lability Index (GLI). STATISTICAL ANALYSIS Data analysis will be performed~          with Kolmogorov-Smirnov test; parametric and non-parametric s tests, t-test (or~          Mann-Whitney test), ROC Curve, binary logistic regression. Subgroups analysis.~      Statistical significance: p < 0,05. SAMPLE SIZE 3300 patients.~   "
30340|NCT02659982|"~     The aim of this study is to evaluate the relevance of the information as provided by the~     EarlySense Home care Tele-monitoring system can provide relevant flagging information for~     clinicians to identify the patients at higher risk to proactively assess patients' condition~   "
30341|NCT02659956|"~     Background:~      Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and~     spinal cord). This leads to increased physical disability over time. The disease is lifelong~     once it begins. Researchers want to learn more about MS s stages and follow them until a~     person s death.~      Objective:~      To understand how the physical and clinical signs of MS relate to its changes over time.~      Eligibility:~      Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like~     MS.~      Design:~      Participants will have a medical history and a complete neurological exam. They may have~     timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.~      Participants will have multi-day visits about once a year.~      Participants will have blood drawn.~      Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an~     MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm~     vein. During the MRI, participants will lie on a table that slides in and out of a metal~     cylinder.~      Participants will have the thickness of their retina measured using optical coherence~     tomography. A camera on top of a table uses lasers. Participants will look through a lens~     and follow instructions. Eye drops may be used to dilate the pupils.~      Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.~      Participants agree to have an autopsy at the time of their death and to donate some of their~     organs to research, such as the brain and spinal cord.~   "
30342|NCT02659943|"~     Background:~      The immune system fights infection and can affect cancer cells. T cells are white blood~     cells that are a major part of the immune system. T cells can destroy tumors. Researchers~     want to try to manipulate the immune system to better recognize and kill tumor cells.~      Objective:~      To test the safety of giving T cells expressing a novel fully-human anti-CD19 chimeric~     antigen receptor (CAR) to people with advanced B-cell cancer.~      Eligibility:~      People ages 18 73 with a B-cell cancer that has not been controlled by other therapies.~      Design:~      Participants will be screened with:~      Physical exam~      Blood and urine tests~      Heart tests~      Bone marrow sample taken~      Scans in machines that take pictures~      Participants will have apheresis. Blood is removed through a needle in an arm. T cells are~     removed. The rest of the blood is returned through a needle in the other arm.~      The cells will be changed in a laboratory.~      Participants will get 2 chemotherapy drugs over 3 days.~      Two days later, participants will check into the hospital. They will get an intravenous (IV)~     catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.~      After this, participants will stay in the hospital for at least 9 days and stay nearby for 2~     weeks. Then they will have blood tests and see a doctor.~      Participants will have visits 6 visits for 1 year after the infusion. Some may have more~     follow-up visits.~      Participants may samples taken of spinal fluid, bone marrow, and tumors.~   "
30343|NCT02659930|"~     Background:~      Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These~     are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract.~     Researchers think a combination of drugs may help treat KS.~      Objective:~      To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal~     doxorubicin (Doxil) in people with KS.~      Eligibility:~      People ages 18 and over with KS~      Design:~      Participants will be screened with:~      Medical history~      Questionnaires~      Physical exam~      Blood, urine, and heart tests~      Chest X-ray~      Biopsy: A small sample of tissue is taken from a KS lesion.~      Possible CT scan~      Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument~     examines~      inside the organ.~      Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day~     1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of~     each cycle.~      Participants will have many visits:~      Before starting treatment~      To start each cycle~      Day 15 of first 2 cycles~      Visits include repeats of screening tests and:~      Multiple blood draws~      Photographs of lesions~      Participants will keep a drug diary.~      Participants will take aspirin or other drugs to prevent blood clots.~      Participants with HIV will have combination antiretroviral therapy.~      Some participants will have a PET scan.~      Participants will continue treatment as long as they tolerate it and their KS improves.~     After treatment, they will have several follow-up visits for up to 5 years~   "
30344|NCT02659917|"~     The purpose of this randomized clinical trial was evaluate the performance of two~     conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative~     treatment in high caries risk children.~   "
30345|NCT02659904|"~     Our primary objective in this clinical intervention study, therefore, was to explored the~     effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and~     6 months after free gingival graft harvesting in order to determine as soon as possible to~     re-harvest gingival graft from same site.~   "
30347|NCT02659878|"~     Pupose:~      Takotsubo cardiomyopathy is a rare and not well-known complication of the subarachnoid~     hemorrhage.~      This form of heart failure, called as broke heart or apical ballooning syndrome, was~     first described by Japanese authors at the beginning of 1990's.~      1.5-2.2% of acute coronary syndrome is Takotsubo cardiomyopathy. Its predisposing factors,~     hypothetical parthenogenesis, diagnostic criteria and therapeutic methods are already known~     from the literature.~      The study intends to include all patients over 18 years of age who were admitted to our~     clinic within 48 hours after the bleeding regardless of gender, neurological status or age.~      Data to be registered within 24 hours after admittance:~      Instruments:~        -  Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler;~          systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio,~          pulsatility index~        -  ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia~        -  Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion~          abnormalities) - documented with video recording~      Hypothesis:~      The risk of Takotsubo cardiomyopathy (TS) is increased if SAH is associated with more severe~     state, a greater degree of bleeding, intraventricular and/ or intracerebral hemorrhage.~      The definitive care of patients is postponed due to the appearance of TS, which could affect~     the final outcome.~   "
30348|NCT02659865|"~     The main purpose of this study is to investigate the safety of the study drug known as~     LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part~     A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.~     Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,~     over the course of the study. Both parts of the study will also explore how much LY3039478~     gets into the bloodstream and how long it takes the body to get rid of it. Information about~     any side effects will also be collected. Participants may only enroll in one part. The study~     will last at least 33 days, not including screening. Screening must be performed up to 30~     days before enrollment.~      Part B was added by protocol amendment approved in April, 2016.~   "
30349|NCT02659852|"~     Malignant obstructive jaundice is a common complication of advanced stage~     cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy,~     biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the~     therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent~     used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar~     biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was~     conducted to show the superiority of bilateral metal stent insertion between stent in stent~     and side by side. Biliary drainage and stent patency was a little superior in side by side~     than stent in stent. But, complication related with bilateral metal stent was increased in~     patients with side by side method. Another study showed that there was no significant~     difference between those bilateral stent insertion methods. The most important concern about~     side by side method is associated with portal vein thrombosis by bilateral stent diameter.~     Selection of proper stent insertion method in patients with hilar malignant biliary~     obstruction is still controversial.~      The purpose of this study is to investigate the patency of stent and survival of patients in~     side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD~     type) in patient with hilar malignant biliary obstruction.~   "
30350|NCT02659839|"~     The purpose of this study is to determine 30 day mortality in cancer patients admitted to~     the intensive care unit in a resource limited setting.~   "
30351|NCT02659826|"~     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed~     once a week in a counterbalanced order and at least with seven days washout period to~     minimize carry-over effects. In each session, volunteers will be submitted to quantity and~     quality of sleep, type of eating, fatigue and motivation level, cortical brain activity~     measures through paired pulse transcranial magnetic stimulation (ppTMS), spinal cord~     activity measures through electrical stimulation, non-invasive spinal stimulation (tsDCS) or~     non-invasive brain stimulation (rTMS) and physical exercise (gait training).~   "
30352|NCT02659813|"~     This study protocol is for a randomised clinical trial which aims to test two materials used~     as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi)~     archwires. Both professional and patient related outcome measures are to be used to fully~     evaluate performance.~   "
30353|NCT02659800|"~     This pilot, partially randomized clinical trial studies how well glycosylated recombinant~     human interleukin-7 works in increasing low cluster of differentiation (CD)4 counts after~     concurrent radiation and temozolomide treatment in patients with gliomas that tend to grow~     rapidly and spread (high-grade). Treatment with radiation and chemotherapy, such as~     temozolomide, may cause an abnormal decrease in CD4 cells, which are an important part of~     the immune system. Glycosylated recombinant human interleukin-7 may increase CD4 cell counts~     and improve survival.~   "
30354|NCT02659787|"~     This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on~     depressed mood in a healthy young adults with a range of depressive symptomatology.~   "
30355|NCT02659774|"~     This study has the following objectives:~        1. To examine the employers'/managerial staff's knowledge, attitudes and practices in~          promoting smoking cessation in workplace.~        2. To evaluate the smoking behaviours of participants before and after attending a smoking~          cessation intervention.~   "
30356|NCT02659761|"~     The purpose of this study is to assess the tolerability, adherence and efficacy of single~     tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV~     with a history of injection drug use (IDU) switching from existing antiretroviral therapy~     (ART) or starting treatment after discontinuation of ART.~   "
30357|NCT02659748|"~     This study investigates the effects of bioactive fatty acids in full fat dairy (whole~     yogurt), on insulin action, calorie needs, blood lipids, immune function, and body~     composition in normal and overweight male and female volunteers.~   "
30358|NCT02659735|"~     The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872~     following administration of a single dose as three different concept formulations with that~     following administration of the current formulation, under both fed and fasted conditions,~     in healthy adult participants.~   "
44814|NCT02470429|"~     The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total~     ocular surface staining scores (TOSS) at Day 42.~   "
30361|NCT02659696|"~     Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan,~     and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for~     pruritus in patients with chronic liver diseases including PBC. In the current study, the~     investigators aimed to assess pruritus and overall QOL before and after administration of~     nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum~     sample from the enrolled patients and examine the association of pruritus with possible~     biomarkers.~   "
30362|NCT02659683|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR~     Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of~     studies were separated by a washout period of 4 days.~   "
30363|NCT02659670|"~     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema~     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All~     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to~     apply it once daily per package insert. Adherence will be assessed using weekly internet~     surveys to document how often the medication is being used, as well as reminders about~     rosacea triggers and general use of brimonidine.~      Subjects with persistent erythema associated with rosacea will be recruited from the Wake~     Forest Baptist Health Dermatology Clinics and IRB approved advertising. At the baseline~     screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator.~     Subjects will be classified as having erythematotelangiectatic or a combination~     erythematotelangiectatic and papulopustular. Study staff will evaluate whether subjects~     believe they have constant erythema or more intermittent flushing and blushing. Subjects~     will be informed of the benefits and risks of treatment. If they agree to participate, the~     subjects will give written consent approved by the Institutional Review Board and will be~     seen in follow up at 3 months and 6 months.~      Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard~     care non-survey group. The internet survey will ask them how often they have used their~     medication that week, as well as giving them treatment tips and reminders about rosacea~     triggers. Subjects will be asked a variety of questions during the weekly internet survey;~     such as the amount of erythema they currently have (measured by VAS scale), how much burning~     and stinging they have, how often they have used the medication and where did they apply the~     medication, as well as any additional side effects they may be having from the medication.~      Subjects in the non-internet survey group will just get these identical surveys at the Month~     3 and Month 6 visits. The Investigator is also interested in learning through the adherence~     surveys if subjects begin using the medication on an as needed basis, and if this affects~     the side effect profile and satisfaction with the medication.~   "
30364|NCT02659657|"~     The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow~     transplantation (HBMT) on hematological malignancies are well established.The aim of this~     prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be~     decreased with IL2 therapy post HBMT.~   "
30365|NCT02659644|"~     Sickle cell disease is a genetic red blood cell disorder that can result in blocking of the~     small blood vessels from sickle shaped red blood cells. This causes pain, the main feature~     of sickle cell disease. Also, low amounts of nitric oxide can occur in sickle cell disease,~     a substance important for widening the blood vessel wall and therefore preventing blockage~     of the small blood vessels.~      Citrulline is a drug that is known to increase nitric oxide. This is a phase I study of~     citrulline given by mouth to evaluate the safety, tolerability and appropriate dosing of~     this medication for individuals with sickle cell disease.~   "
30366|NCT02659631|"~     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing~     doses of PF-06671008 in patients with advanced solid tumors with the potential to have~     P-cadherin expression. The study will then expand to look at the selected dose in patients~     with P-cadherin expressing TNBC, CRC or NSCLC.~   "
30367|NCT02659618|"~     The goal of this study is to identify a serum biomarker(s) that can detect increased levels~     of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the~     blood of patients with severe persistent asthma.~   "
30368|NCT02659605|"~     The purpose of this study is to determine if delayed cord clamping above the perineum has an~     effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in~     pre-term spontaneous vaginal deliveries.~   "
30369|NCT02659592|"~     Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology~     centers. Patients: 20 cancer survivors who underwent ovarian transplantation of~     frozen-thawed ovarian tissue, with the aim to conceive.~      Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine~     monitoring, IVF.~   "
30370|NCT02659579|"~     The investigators will evaluate the effectiveness of a parent-child shared reading~     intervention run by The Reader Organisation. The investigators will be asking parents and~     children across Liverpool to either (i) attend a weekly shared reading programme or (b) to~     attend a weekly children's reading group at a library. The investigators will look at how~     the reading groups affect children's language development, by comparing children's language~     development before having gone to these groups and after they have attended these groups.~   "
30371|NCT02659566|"~     Background:~      Malaria is a disease that affects many people in the country of Mali and other parts of~     Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but~     can also be serious or can lead to death if not diagnosed and treated promptly. Children~     younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to~     better understand how malaria infection suppresses the immune system. They want to compare a~     group of adults who receive antimalarial treatment to a group that does not receive it.~      Objective:~      To investigate the effect of antimalarial treatment at the beginning of the dry season on~     the immune system and malaria episodes.~      Eligibility:~      Healthy adults ages 18 60 who live in the area of Doneguebougou, Mali.~      Design:~      Participants will be screened with a physical exam and health questions.~      If participants are found to be sick at the screening visit, they will get initial care at~     the study clinic free of charge. They may get referrals for consultation.~      Participants will be randomly assigned to a group. One group will get an approved~     antimalarial drug called Coartem . The other will not receive it.~      Participants in the Coartem group will take the drug for 3 days.~      All participants will have blood tests.~      Al participants will be seen about once a month for about 1 year. At each visit, they will~     be asked how they are feeling and be examined. Blood will be drawn.~      If participants become sick at any time, they will come to the clinic to be examined.~   "
30372|NCT02659553|"~     1. Clinical impact of graft steatosis on postoperative complications after OLT.~        2. Recommendations to improve outcomes after transplantation of steatotic livers and~          increase donor pool.~   "
30373|NCT02659540|"~     This is an open-label, multicenter pilot Phase 1 study of the checkpoint antibodies~     ipilimumab and nivolumab in combination with radiotherapy in 18 subjects with unresectable~     stage IV melanoma. All subjects will receive concurrent ipilimumab (3 mg/kg) and nivolumab~     (1 mg/kg) every 3 weeks for 4 doses, followed by nivolumab monotherapy (3 mg/kg) every 2~     weeks. Radiotherapy will be initiated after the first dose and before the second dose of~     immunotherapy.~   "
30374|NCT02659527|"~     This diagnostic clinical trial will be conducted according to a randomized, prospective,~     controlled, double-arm, single-centre design. The control will be implemented by comparing~     the PET/MRI results with the histopathological finding after radical prostatectomy (positive~     state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and~     standard biopsy are negative (negative state) and/or the detection of a biochemical tumor~     relapse (rising PSA after PSA nadir; secondary objective).~   "
30375|NCT02659514|"~     The purpose of this study is to evaluate the efficacy and tolerability of poziotinib in~     patients with HER2-positive metastatic breast cancer who have received at least 2 prior~     HER2-directed treatment regimens.~   "
30376|NCT02659501|"~     Objectives:~        1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.~        2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and~          opioid related adverse events.~        3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.~        4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with~          postoperative pain control.~        5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.~   "
30377|NCT02659488|"~     The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain~     Dysfunction in Binge Eating Disorder~   "
30378|NCT02659475|"~     The goal of this project is to evaluate the effectiveness and tolerability of the novel~     weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle~     modification counseling in the treatment of binge eating disorder (BED) in overweight or~     obese individuals.~   "
30379|NCT02659462|"~     prospective cardio respiratory evaluation for patients post the Fontan palliation for single~     ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy~     volunteers in order to evaluate the functional capacity and the primary etiology for~     reduction in functional capacity.~   "
30380|NCT02659449|"~     The purpose of this study is to determine the impact of compressing therapy on the dexterity~     of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board /~     Jamar's test)~   "
30381|NCT02659436|"~     The purpose of this pilot study is to explore whether there is a differential impact of~     verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation~     strategy for individuals with social anxiety disorder (SAD). Clients who have not~     demonstrated clinically significant change following group CBT for SAD will receive four~     additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that~     that individuals who receive imagery-based CBT will experience even stronger improvements~     and be more satisfied with their treatment than individuals who received traditional~     verbal-linguistic CBT.~   "
30382|NCT02659423|"~     Bystander interventions, recognized as promising violence prevention strategies, are unique~     in their engagement of all community members to 1) recognize situations that may become~     violent and 2) learn to safely and effectively intervene to reduce violence risk. Based on~     their promise, the Campus Sexual Violence Elimination Act (SaVE) now requires all~     publicly-funded colleges to provide bystander intervention. With SaVE's policy intervention~     requiring bystander interventions, a natural experiment has arisen to determine the~     relative efficacy of students' bystander training across multiple colleges. Investigators~     propose a quasi-experimental design (using fractional factorials) to evaluate the relative~     efficacy of three bystander interventions to reduce violence in college communities. Green~     Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has~     found that Green Dot is associated with a 20-40% reduction in VAW in college and high school~     settings.~      In aim 1, investigators will compare the relative efficacy of bystander interventions to a)~     increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce~     interpersonal violence victimization and perpetration, and d) increase program cost~     effectiveness. The three main bystander groups compared will be: exclusively online~     training, Green Dot (speeches and intensive bystander training), and other skills-based~     bystander training. Program efficacy data will be obtained from student surveys, campus~     crime statistics, and surveys with college staff and administrators responsible for~     selecting and implementing bystander interventions.~      In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher~     communities will form through researchers' engagement with college recruitment, survey~     design, data collection and analyses. Specifically investigators will determine the efficacy~     of this program to increase VAW prevention research productivity defined as a) increasing~     research skills and b) increasing research communications measured as manuscript~     submissions, presentations, and publications.~      This natural experiment will generate new understanding into efficacy of how bystander~     programs work. This natural experiment will also provide the VAW research community an~     opportunity to increase our skill-sets and share our experiences with and help grow the next~     generation of VAW prevention researchers.~   "
30383|NCT02659410|"~     In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds.~     Exposure to heat induces physiological responses that help maintaining a stable body~     temperature. Those changes can affect organ functions implicated in absorption and~     metabolism. According to literature, those changes could lead to increased concentrations of~     chemical compounds in the body and their toxicity. Therefore, the aim of this study is to~     evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress~     conditions in volunteers exposed in a inhalation chamber. Results will then be used to~     develop PBPK models that will allow to predict organic solvent kinetics when coexposed with~     heat.~   "
30384|NCT02659397|"~     The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in~     the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol)~     and other markers of health and disease in blood and urine, and to see how ETC-1002 is~     tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background~     therapy in statin-treated patients.~   "
30385|NCT02659384|"~     This is a randomized phase II study, aimed at evaluating the efficacy (through progression~     free survival at 6 months) and safety of 5 different treatments involving atezolizumab,~     bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian~     cancer patients in order to select the optimal treatments for further development in Phase~     III.~   "
30386|NCT02659371|"~     Due to a higher risk of complications, obese and overweight patients with macromastia are in~     Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.~      The study is a pilot study with a diet intervention group and no control group. The~     intervention is a 12 week low energy diet pre-operative weight loss program investigating if~     this will result in weight loss making the overweight and obese patients eligible for breast~     reduction surgery i.e. BMI < 25.~   "
30412|NCT02659033|"~     CEREMI is an open, randomised prospective study in parallel groups in healthy volunteers.~     This study compare the effect of a monotherapy by ceftriaxone or cefotaxime on the emergence~     of resistance of enterobacteria to 3rd-generation cephalosporins within the intestinal~     microbiota. Each volunteer will be treated for 3 days by either ceftriaxone (1 gram per day)~     or cefotaxime (1 gram every 8 hours).~   "
33444|NCT02619305|"~     The objective of our study is to determine whether a livelihood intervention can change~     economic and psychosocial outcomes of social network ties and geographically proximate~     neighbors of impoverished women in rural Uganda.~   "
30387|NCT02659358|"~     The purpose of this study is to evaluate the association between wearable biosensor data,~     performance status and patient-reported outcomes in cancer patients. Participants in this~     study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires~     that will assess patient reported outcome measures including physical function, emotional~     distress, pain interference, sleep disturbance and fatigue.~      Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18~     years of age and be English speaking due to the questionnaires that will be administered~     during the study. Patients must also be ambulatory (use of walking aids, such as cane and~     rollator, is acceptable) and have access to a smartphone with internet access (IOS or~     Android). It is also necessary for patients to have scheduled oncology clinic visits at~     least once every 2 weeks.~   "
30388|NCT02659345|"~     Participants in this research study are asked to tell about their experience with art~     therapy. Participants in this research study are currently receiving chemotherapy treatment~     for cancer. The purpose of this study is to learn how art therapy affects mood, anxiety,~     pain, and emotions of individuals with cancer who are undergoing chemotherapy.~   "
30389|NCT02659332|"~     -  Primary Objective: To show that small pTa bladder tumors can be removed with diode~          laser in an outpatient department.~        -  Secondary Objective: To evaluate the patients' symptoms during and after the laser~          TURBT.~        -  Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the~          laser TURBT.~   "
30390|NCT02659319|"~     The purpose of the study is to test the effectiveness of a child obesity intervention with~     multiple components targeting nutrition and/or psycho-social factors in children, their~     parents, and their classmates. The specific aims of the study are to (1) Determine the~     effectiveness of two family-level interventions for improving child outcomes (unhealthy~     eating, low activity, and overweight); (2) Determine the extent to which adding a family~     dynamics component enhances the effectiveness of a family lifestyle intervention and~     improves the child outcomes listed above; and (3) Determine the extent to which a peer-level~     intervention improves the effectiveness of two family-level interventions among overweight~     children.~   "
30391|NCT02659306|"~     Anti-HIV drugs cut down the number of serious infections that people with HIV get. However,~     some subjects taking anti-HIV drugs do not achieve adequate cluster of differentiation 4~     (CD4) recovery and decrease in elevated cluster of differentiation 8 (CD8) cells. Such~     patients with a low CD4/CD8 ratio remain at risk for developing acquired immune deficiency~     syndrome (AIDS) and non-AIDS-related complications. Two of the most important factors~     associated with low CD4/CD8 ratio include: the persistence of HIV on ART and inflammation.~      Metformin, the most widely used medication to treat type 2 diabetes, is well tolerated with~     minimal side effects. It has been linked to anti-aging and weight reducing properties in~     non-diabetic persons. Because of its ability to improve immune functions, metformin could be~     a promising addition to ART in HIV patients. It is also reported to change the composition~     of microbes in the gut which may improve inflammation.~      PURPOSES OF THE STUDY~      The purposes of this study are to find out if:~        1. metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in~          the body;~        2. metformin can be combined with anti-HIV drugs to improve immune function.~        3. metformin can be combined with anti-HIV drugs to impact CD4 T cell count and CD4/CD8 T~          cell ratio during treatment and after its discontinuation~        4. metformin can change the composition of the bacteria in the gut which may improve~          inflammation.~      For this purpose, the investigators will add metformin at the usual antidiabetic dose for 12~     weeks for patients receiving stable ART, having a CD4/CD8 ratio below 0.7.~      Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness~     Service of the McGill University Health Centre, the Ottawa Hospital and the Maple Leaf~     Medical Clinic (Toronto). This study will last about 24 weeks; metformin treatment will be~     for 12 weeks. In order to be eligible for the study, the participants must be 18 years of~     age or older, have an undetectable viral load (the quantity of the HIV virus in the blood~     must be less than 50 copies/ml) for at least 3 months and have a CD4/CD8 ratio of less than~     0.7. All participants will also be asked to give blood and stool samples and optional colon~     mucosal biopsy samples (before and after metformin supplementation) to study the size of the~     viral reservoir and the amount of T cell activation and changes in gut microbiota~     composition.~   "
30392|NCT02659293|"~     This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus~     lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who~     completed autologous stem cell transplant for symptomatic myeloma who are considered for~     lenalidomide maintenance.~   "
30393|NCT02659280|"~     This study will take about 3-16 months. Participants will be inpatients in the Hennepin~     Health System that are transitioning into outpatient or home health Physical Therapy or~     current outpatient patients. Investigators will assess 24 participants for eligibility based~     on the study's inclusion criteria. If eligible, Investigators will attain informed consent~     and provide instruction on how to use a coaching app, Hudl Technique, and enter data in the~     Apple Health Kit (all participants will be gifted an iPad mini 4, cover and Hudl Technique~     app). Baseline Body Mass Index (BMI) will be taken and entered in the Apple Health Kit.~     Randomization (1:1) will occur by an outside statistician. 12 patients will be allotted to~     the control group (receive traditional OP PT and have access to the Apple Health Kit and~     Hudl Technique with the gifted iPad). 12 patients will be the variable group (receive~     traditional OP PT, have access to the Apple Health Kit and Hudl Technique with the gifted~     iPad, and have an adjunct Home Exercise Program which will be administered via tele-health~     store and forward technology 1x/wk). There will be an 8 week assessment in which~     Investigators plan to measure 1) satisfaction with PT (via survey) 2) Home Exercise Program~     (HEP) compliance (via survey) 3) incidents of ED visits or hospital admissions 4) BMI (via~     patient report with option to put it in the Apple Health Kit). There will be a 24 week~     assessment in which investigators will measure the same 4 measurements. Investigators plan~     on performing this protocol for an additional 24 participants in late 2016/early 2017 (48~     participants in total). Unfortunately, this will be a non-blinded (assessor, therapist and~     participant) study due to the nature of the intervention and how investigators received the~     funding. Casey Byron will be the Principal Investigator. Investigators would like the~     statistician to be blinded to group allocation until completion of the study (roughly~     3/11/2017).~   "
30394|NCT02659267|"~     The study aims to verify if the VAMOS strategy contributes to an increase in physical~     activity and healthy eating habits among users of the Health Academy Program from Belo~     Horizonte, Minas Gerais.~   "
30395|NCT02659254|"~     This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular~     Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is~     to access the preliminary safety and efficacy of Firesorb implantation in the human body,~     and to provide evidence for subsequent large-scale, multi-center, randomized controlled~     clinical trials. Then provide the basis for the formal application of the product in China.~   "
30396|NCT02659241|"~     The goal of this clinical research study is to learn if certain characteristics of DNA (the~     genetic material in cells) affects how ovarian, fallopian tube, or primary peritoneal~     carcinomas respond to therapy with AZD1775. Researchers also want to learn if treatment with~     AZD1775 affects the DNA in cancer cells.~   "
30413|NCT02659020|"~     The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer~     drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in~     participants with advanced soft tissue sarcoma (STS) or STS that has spread to another~     part(s) of the body.~   "
30492|NCT02657980|"~     Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:~     Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind~     (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment~   "
30397|NCT02659228|"~     In this study, the investigators explore anesthesia as a tool for providing further insight~     into the level of consciousness of individuals with a clinical diagnosis of unresponsive~     wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious~     awareness. This group, who could potentially be conscious, will herein be referred to as the~     target population. Our goal is to assess whether or not neurological patterns of~     consciousness in the target population respond to anesthesia in a similar manner to~     neurologically compromised individuals with known consciousness (e.g. those in minimally~     conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an~     elimination of the mismatch negativity event-related brain potential (ERP) and a diminished~     directed connectivity. The investigators hypothesize that at doses well below those required~     for surgery, anesthesia will have similar effects on these neural patterns in neurologically~     compromised patients with the potential for conscious awareness, but will not affect these~     patterns in those who lack consciousness.~   "
30398|NCT02659215|"~     The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with~     bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of~     symptomatic cartilage defects of the knee.~   "
30399|NCT02659202|"~     The purpose of this proposal is to determine whether epidural spinal cord stimulation can~     modulate cardiovascular control during exercise in Heart Failure patients.~   "
30400|NCT02659189|"~     The purpose of this study is to create an institutional registry of Chronic Obstructive~     Pulmonary disease through a prospective survey based on epidemiological data, risk factors,~     diagnosis, prognosis, treatment, monitoring and survival.~   "
30401|NCT02659176|"~     Comparison between transperineal repair of rectocele with or without posterior internal~     sphincterotomy.~   "
30402|NCT02659163|"~     The high prevalence and burden of cardiometabolic disease underlie the urgent need to~     identify novel approaches to managing and preventing cardiometabolic disease and risk. This~     project will test an innovative use of mobile health technology to implement a closed-loop~     feedback system that collects objective patient-generated data and provides clinical~     recommendations to modify contributing health behaviors. In addition to improving care for~     cardiometabolic disease, the tools and methods developed by this study for collecting~     patient data and providing clinical feedback could also easily be adapted and applied to a~     range of other health conditions, and are thus highly relevant to public health.~   "
30403|NCT02659150|"~     The purpose of this study is to test the hypothesis that anti-IL-6 therapy is effective for~     reducing plaque inflammation as measured by fluorine-2-deoxy-D-glucose positron emission~     tomography (FDG-PET) in patients with rheumatoid arthritis (RA) who are synthetic~     disease-modifying antirheumatic drugs (dMARD) inadequate responders and are naive to~     biologic therapy.~   "
30404|NCT02659137|"~     TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers~     that differ considerably between devices. There is an increased risk of progression to total~     AV‐block at follow‐up, with the risk of brady‐arrhythmic death.~      The aim of the study is to elucidate the anatomical location of the conduction pathology of~     a TAVI induced LBBB. This could impact valve design and placement and thereby reduce the~     number of new LBBB induced by TAVI in the future. Furthermore, finding predictors for~     progression to a high degree AV block in the follow‐up (and thus an indication for permanent~     pacemaker) could improve management of post‐operative conduction abnormalities and prevent~     the risk of brady‐arrhythmic death.~   "
30405|NCT02659124|"~     This is a comparison trial with novel application of AmnioFix and a control arm. Patients~     electively being treated with facial lasers will be assigned to receive AmnioFix in addition~     to the normal standard of care placed on half of their face after laser procedure, and~     normal post laser standard of care alone on the other half of their face. The investigators~     will investigate the end points of healing, recovery time, re-epitheliaziation, and other~     cosmetic factors. The study is designed to compare AmnioFix to the current standard of laser~     care.~   "
30406|NCT02659111|"~     Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties~     regarding gait, balance, cognition and micturition. A shunt operation will improve these~     difficulties in most cases. Data suggest however, that they do not change their physical~     activity postoperatively. Physical training has been shown to be beneficial in patients with~     similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical~     training program after a shunt operation to see if the patients can improve their physical~     capacity and ambulatory activity more than patients who only receive standardized written~     advice about physical training.~   "
30407|NCT02659098|"~     The purpose of this study is to evaluate the safety and performance profile of a modified~     surgical procedure and custom Delivery System and also to assess the effects on best~     corrected visual acuity of a single subretinal administration of CNTO 2476.~   "
30408|NCT02659085|"~     Developing more effective and faster acting antidepressant is of outmost clinical~     importance. Available antidepressant therapies have a delayed therapeutic effect. It~     typically takes several weeks before symptom relief is evident. Furthermore, antidepressants~     are relatively ineffective - as many as 30% of patients do not respond to any medication at~     all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a~     potentially new antidepressant treatment for severely depressed patients and compare its~     effectiveness with that of electroconvulsive therapy (ECT).~   "
30409|NCT02659072|"~     Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans~     vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination~     and probe disinfection. This will allow modeling the risk of HPV transmission, and could~     contribute establishing future guidelines for reducing the risk of transmission of~     microorganisms and the risk of infection through TVS.~   "
30410|NCT02659059|"~     The purpose of part 1 of this study is to determine the objective response rate (ORR) in~     stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line~     therapy.~      The purpose of part 2 of this study is to compare overall survival of Nivolumab and~     ipilimumab combined with a short course of chemotherapy to standard of care chemotherapy in~     first line stage IV NSCLC.~   "
30411|NCT02659046|"~     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit~     treatment methods on traumatic brain injury (TBI) patient prognosis.~   "
30414|NCT02659007|"~     The long-term goal is to identify and establish effective mind-body interventions (as an~     aspect of complementary and alternative medicine) to improve health and Quality of Life~     (QoL) for people with disabilities. Preliminary data suggest that engagement in yoga is~     feasible and beneficial for multiple study populations, and it may relieve symptoms of~     neuropathy. The central hypothesis is that individuals who complete yoga will have~     significantly better balance, mobility, and QoL after 8 weeks of yoga.~   "
30415|NCT02658994|"~     Background~      The negative effects of perinatal depression on mother and child start early and persist~     throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal~     depression in their first year of life, 16 mitigating this intergenerational risk is a~     global public health priority. However, there is a dearth of studies on whether a maternal~     depression intervention can have long-term benefits for either the mother or her child. This~     is a study of the effectiveness of an extended 36-month peer-delivered depression~     intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in~     rural Pakistan.~      Study Design~      The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression~     intervention on mother and child outcomes using a cluster randomized controlled trial~     (c-RCT) design. The trial will recruit 560 pregnant women who screened positive for~     perinatal depression (PHQ-9 >=10) from 40 village clusters, of which 20 clusters will~     receive the THPP+ intervention delivered by trained peers. These women will have already~     been participating in the trial of the shorter, 6 month long, version of the intervention.~     Women in the THPP+ intervention arm will receive bimonthly group-based sessions. Primary~     outcomes are 3-year maternal depression and 3-year child socio-emotional and cognitive~     development. All primary analyses will be intention-to-treat and will account for the~     clustered study design.~      Discussion~      This trial has the potential to further significantly our understanding of whether~     intervening on women's perinatal depression can mitigate the negative effects of maternal~     depression on 36-month child development.~   "
30416|NCT02658981|"~     This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal~     antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating~     patients with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody~     BMS-986016, urelumab, and nivolumab are antibodies (a type of protein) that may stimulate~     the cells in the immune system to attack tumor cells. It is not yet known whether anti-LAG-3~     monoclonal antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill~     more tumor cells.~   "
30417|NCT02658968|"~     This study is a phase 1, dose finding, open-label study in patients with relapsed diffuse~     large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum~     tolerable dose of 177Lu-DOTA-HH1 (Betalutin®) in DLBCL patients who are not eligible for~     autologous stem cell transplant. The study will also assess safety and toxicity,~     pharmacokinetics, biodistribution and efficacy.~   "
30418|NCT02658955|"~     Implementing guidelines of EHS for abdominal wall closure in all specialities of a General~     Hospital. Migrating from large stitch technique to short stitch technique.~   "
30419|NCT02658942|"~     to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy~     (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal~     stones (LC) stones.~   "
30420|NCT02658929|"~     Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in~     adults with relapsed/refractory multiple myeloma (MM).~   "
30421|NCT02658916|"~     The purpose of this study is to evaluate the long-term safety and tolerability of multiple~     intravenous (IV) infusions of BMS-986168 in patients with Progressive Supranuclear Palsy~     (PSP). The study will also assess the pharmacodynamic (PD) effects of BMS-986168 on~     cerebrospinal fluid (CSF) extracellular tau (eTau), pharmacokinetics (PK), and~     immunogenicity of BMS-986168 in patients with Progressive Supranuclear Palsy.~   "
30422|NCT02658903|"~     The safety and efficacy of a urinary catheter designed to prevent catheter associated~     urinary infections is studied.~   "
30423|NCT02658890|"~     The purpose of the study is to determine safety, tolerability, pharmacokinetics and~     pharmacodynamics of BMS-986205 when combined with Nivolumab [an anti-Programmed cell~     Death-1(anti-PD1) antibody] in patients with advanced cancers.~   "
30424|NCT02658877|"~     The primary purpose of this study is to identify additional mechanisms of action of~     omalizumab that will lead to improved stratification of patients for treatment.~     Understanding the response of specific innate immune effector cells in the lung can provide~     clues to these questions. Investigators will use non-invasive measures of a discrete cell~     population to examine the downstream effects of omalizumab treatment in the lung.~     Information derived from these studies will help clarify mechanisms of action of omalizumab~     and help identify potential tools for patient endotyping and stratification for therapeutic~     interventions.~   "
30425|NCT02658864|"~     This study was to evaluate the pharmacokinetics of single and multiple doses of oral~     lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects.~     The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated~     to acquire more pharmacokinetic information.~   "
30426|NCT02658851|"~     This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based~     plasma technology in the reduction of lymphoceles following pelvic lymph node dissection~     (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be~     used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to~     prevent lymph leakage.~   "
30427|NCT02658838|"~     The purpose of this study is to determine ticagrelor combining with low molecular weight~     heparin is effective and safe during PCI or not.~   "
30428|NCT02658825|"~     The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval~     at supratherapeutic exposure in healthy participants (Panel 2).~   "
30429|NCT02658812|"~     The goal of this clinical research study is to learn if talimogene laherparepvec can help to~     control recurrent breast cancer. The safety of this drug will also be studied.~   "
30442|NCT02658643|"~     The aim of this prospective randomized controlled study is to determine the benefit-risk~     ratio (success rate, complication rate, tolerance) for patients with biliodigestive~     anastomosis by either continuous or interrupted suture.~   "
30430|NCT02658799|"~     Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and~     pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because~     of related side effects, cyclic administration of NSAIDs may reduce or eliminate these~     effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on~     clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta)~     in the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects~     with moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test~     and control) after initial periodontal therapy. During this 6-month, randomized,~     double-blind, placebo-controlled study, test (n = 28) and control (n = 13) groups were~     administered a cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo.~     Clinical measurements of disease severity and GCF sample collections were made at baseline,~     2, 4 and 6 months. GCF levels of PGE2 and IL1-1beta were determined using EIA and ELISA~     kits, respectively.~   "
30431|NCT02658786|"~     Chronic liver diseases of differing etiologies are among the leading causes of morbidity and~     mortality worldwide [1]. Chronic liver disease progresses through different pathological~     stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic~     fibrosis and cirrhosis [2]. Assessment of the stage of liver disease is important for~     diagnosis, treatment, and follow-up both during treatment and after cessation of treatment.~     A liver biopsy is the oldest and most accurate method used to evaluate liver histology and~     the progression of chronic liver disease. Furthermore, different histological scoring~     systems have been developed and modified [3]. A liver biopsy is considered the gold standard~     for assessing liver histology [4]. During the pathological progression of liver fibrosis,~     excessive amounts of extracellular matrix build up; furthermore, serum levels of various~     biomarkers change, in addition to the appearance of new biomarkers in the serum during the~     different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing~     liver fibrosis have been developed, and they are frequently used in clinical practice. They~     have been validated in different studies, and some were found to be highly accurate in the~     assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used~     as the standard reference method for evaluating the accuracy of noninvasive methods. There~     are limited studies documenting the cost effectiveness of non invasive markers over invasive~     technique.~      Most people with chronic Hepatitis B or C are unaware of their infection, putting them at~     serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly~     patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About~     20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non~     invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different~     drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a~     longitudinal prospective study to assess the cost effectiveness of these diagnostic~     measures.~      We planned to conduct a retrospective followed by prospective cohort study among all cases~     that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV~     infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort~     study, we will collect data from hospital information system for all patients with HBV~     infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during~     the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non~     alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020~     will serve as a cohort for prospective design.~      We will collect socio-demographic data, clinical data, family history, personal history,~     medical history, anthropometry, biochemical and radiological data from each patient. We will~     also be conducting a cost effective analysis for various non invasive markers against biopsy~     as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts.~      For prospective cohort study, after evaluation of baseline biopsy results, the cases with~     metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence~     of development and progression of fibrosis.~      No additional investigation or test will be asked to the patient for the study. We will also~     develop a predicting model for development and progression of fibrosis.~   "
30432|NCT02658773|"~     The purpose of the investigators' study was to evaluate whether cervical~     lidocaine-Prilocaine cream will improve pain scores compared to placebo. The investigators~     hypothesized that lidocaine-Prilocaine cream will reduce the insertion pain.~   "
30433|NCT02658760|"~     Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia~     illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine~     alone on the quality of ultrasonography guided fascia iliaca compartment block in adults~     undergoing femur fracture fixation surgery at 2014.~   "
30434|NCT02658747|"~     This is a multi-center retrospective observational research study collecting data for~     participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer~     (NSCLC) up to 6 years before start of data collection and who have completed/stopped~     docetaxel treatment at least 30 days prior to data collection. The primary goal of this~     study is to describe the percentage of participants with at least one neutropenic sepsis~     (NS) episode following initiation of treatment with single-agent docetaxel. Data will be~     collected until end of docetaxel treatment plus an additional 30 days to allow for~     presentation with toxicity.~   "
30435|NCT02658734|"~     This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess~     the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable~     locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received~     prior treatment with trastuzumab and a taxane.~   "
30436|NCT02658721|"~     Intravenous regional anesthesia (IVRA) is used in outpatient hand surgery as an easily~     applicable and cost-effective technique with clinical advantages. Nevertheless, IVRA has~     some disadvantages including anesthetic toxicity, slow-onset, poor muscle relaxation,~     tourniquet pain, and minimal postoperative pain relief. Providing an ideal anesthesia by~     overcoming these disadvantages is possible with the addition of some adjunct agents into~     local anesthetic substances. One of these adjunct agents used for IVRA is tramadol, a~     synthetic analgesic having opioid and nonopioid characteristics. The present study aimed to~     investigate the effects of addition of systemic tramadol or adjunct tramadol to lidocaine~     for IVRA in patients undergoing hand surgery..~   "
30437|NCT02658708|"~     This proposed study will examine feasibility and implement therapeutic bright light that is~     tailored to the individual's circadian typology to estimate its therapeutic effects on~     sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.~   "
30438|NCT02658695|"~     The aim of this work is to assess the effect of air bubbles localization inside the uterus~     on embryo transfer outcome in ICSI cycles.~      Is there a relationship between embryo transfer outcome and the distance between fundal~     endometrial surface and air bubbles assessed by trans-abdominal ultrasound?~   "
30439|NCT02658682|"~     Depression (Major Depressive Disorder; MDD) has been dubbed the common cold among the~     mental illnesses and it is also a highly recurrent disorder. Secondary prevention has been~     identified as a key goal in the long-term management of depression. High recurrence rate~     suggests that there are specific vulnerability factors that increase people's risk for~     developing repeated episodes of the disorder. Preventive strategies should identify and~     ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased~     attention for emotional stimuli is central to the cognitive model where increased~     sensitivity to negative cues is believed to fuel the negative thoughts and feelings in~     depression and play a key role in maintaining the illness. Selective biases in attention can~     be modified by a simple computerized technique; The Attention Bias Modification Task (ABM).~     This project aims to investigate whether ABM can reduce surrogate and clinical markers of~     relapse in a large group highly vulnerable to depressive episodes. The effects of ABM,~     immediately after the two weeks intervention, on three key risk factors for depression will~     be studied: Residual symptoms, cortisol awakening response and emotion regulation~     strategies. The participants will be followed up after 1 month, 6 months and 12 months. The~     hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months~     in this group in a manner predicted by early changes in these risk factors will be~     investigated. It will also be tested if such effects in the lab may be dependent on~     candidate genes which affect serotonin reuptake and which have been implicated in~     malleability and emotional learning. Effects on underlying neural correlates of emotion~     regulation will be studied in an fMRI experiment in a sub-sample and which will also be~     stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of~     meta cognitions related to rumination and the possible mediating effects of automatic~     thoughts and perceived stress will also be investigated in a sub group (see also~     NCT02648165).~      The characterization of the cognitive, genetic and neural mechanisms underlying the ABM~     effect will have key implications for future treatment development and combination with~     other treatment modalities like pharmacotherapy.~   "
30440|NCT02658669|"~     Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have~     suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury~     symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI~     patients has the potential to exacerbate other symptoms, delay recovery, and negatively~     affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby~     decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has~     been shown to be an effective evidence-based treatment for insomnia, there are no published~     randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I~     in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to~     provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who~     have suffered mTBI.~   "
30441|NCT02658656|"~     Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and~     quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have~     completed rehabilitation after injury and are unable to ambulate receive a wheelchair as~     standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently~     become available as an alternate form of mobility by providing an external framework for~     support and computer controlled motorized hip and knee joints to assist with over ground~     ambulation.~   "
30443|NCT02658630|"~     The purpose of this study is to design a predictive model of stroke recovery based on~     baseline measurements of arm movement and brain physiology. The expectation is the~     development of a formula to predict a person's response to an arm rehabilitation program~     provided in the chronic phase (6 months or greater post stroke) of recovery. The study will~     include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic~     testing using saliva, and an arm exercise program consisting of robot-assisted exercise~     combined with functional arm exercise called transition to task training (TTT).~   "
30444|NCT02658617|"~     The findings may guide future investigations on novel therapeutic targets in depressive~     subjects. Based on the depicted link between personality traits and altered brain metabolism~     and function, the latter might be used as supporting objective measures and possible~     biomarkers for increased depression risk.~   "
30445|NCT02658604|"~     RATIONALE:~      Several examples in the literature describe the types of medication management issues~     uncovered during the course of home-based medication reviews. For example, the investigators~     previously reported the outcomes of home medication reviews of 43 homebound community~     pharmacy patients, finding that 58% of patients were keeping medications in the home that~     were expired, duplicates of other current medications, or no longer therapeutically~     appropriate.~      Many of these issues, due to their nature, could be considered to be hidden, i.e. issues~     that are unlikely to be adequately detected or resolved during the course of routine~     interactions between patients and pharmacists in the community pharmacy setting. Currently,~     only homebound patients in Ontario are eligible to receive government-funded home medication~     review services from pharmacists. This limitation in funding eligibility is problematic as~     it reduces the likelihood that non-homebound patients will receive home medication reviews,~     even though this population may also benefit from these services. Indeed, evidence in the~     literature is not limited exclusively to homebound patients, and suggests that non-homebound~     patients are also at risk from home-centered medication management issues and may also~     benefit from home medication reviews.~      PURPOSE:~      Our study aims to characterize the prevalence and nature of hidden in the home medication~     management issues in non-homebound patients. To our knowledge, this study would be the first~     of its kind to focus specifically on this patient population and lend direct evidence in~     support of expanding funding of home medication review services in Ontario to include~     non-homebound patients.~      HYPOTHESIS:~      A subset of ambulatory, non-homebound patients who regularly attend community pharmacies are~     affected by medication management issues that cannot be adequately identified and resolved~     during the course of a typical medication review taking place within the pharmacy. These~     patients would benefit from a full medication review taking place in their own homes,~     similar to what is presently provided under Ontario's MedsCheck at Home program, for which~     only homebound patients in Ontario are eligible.~      RESEARCH QUESTIONS/OBJECTIVES:~        1. What is the frequency of, and what type(s) and severity of, drug-related problems are~          detected during pharmacist visits to patients' homes who would not otherwise qualify~          for a MedsCheck at Home service?~        2. Based on the findings from this study, which criteria would best assist community~          pharmacists in identifying ambulatory patients who may stand to benefit most from a~          home-based medication review?~   "
30446|NCT02658591|"~     The investigators hypothesized that consuming crackers enriched with faba bean fractions~     (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean~     starch), would reduce the blood glucose response to the meal compared to a crackers without~     faba bean components and reduce food intake at a meal~   "
30447|NCT02658578|"~     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of~     stroke is more dramatic in low- and middle- income countries, and the scarcity of~     evidence-based rehabilitation interventions represents a major challenge to global health~     care. Upper limb weakness is frequent after stroke, but there is no universally accepted~     treatment to effectively improve hand function in patients with moderate and severe motor~     impairment. These are the patients in deepest need of rehabilitative interventions. This~     project addresses this important issue, by testing effects of a novel approach. The~     investigators will non-invasively stimulate peripheral nerves in order to enhance effects of~     motor training aided by an electrical stimulation device in patients with moderate to severe~     hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of~     motor training in patients in the chronic stage after stroke.~   "
30448|NCT02658565|"~     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical~     staging for endometrial cancer increases operative time and surgical morbidity, but appears~     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic~     approach has not been reproduced, and the investigators propose to validate their algorithm~     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary~     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the~     investigators are well-suited to perform this investigation. A surgical approach that is~     tailored to the patient's cancer biology is rational, supported by the recent literature,~     and medically compelling since the co-morbidities of many obese, low-risk EC patients put~     them at significantly increased perioperative risk for complete lymphadenectomy.~   "
30449|NCT02658552|"~     To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the~     treatment of benign thyroid nodules~   "
30450|NCT02658539|"~     Research has shown that body composition is a key component of health and future disease~     risk. Being overweight and obese is associated with a higher body fat composition, and a~     greater risk of developing type II diabetes and heart disease. The location where fat is~     stored in the body is becoming increasingly recognised an important predictor of risk, with~     extra fat around the abdomen and waist (referred to as the android pattern of fat~     distribution or 'apple' shape) thought to increase your disease risk than storing fat around~     the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result,~     there is significant interest in techniques to accurately monitor and detect changes in body~     composition, and also physiological and lifestyle factors which influence body fat, lean~     tissue mass and bone mineral density. This cross sectional human study will look at how~     physiological, behavioural and genetic factors relate to total body composition in 1,196~     healthy men and women aged between 18 and 70 years. Interested applicants will be invited to~     attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of~     Reading. This visit lasts around two hours and includes noninvasive measures of body~     composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial~     stiffness and fasting measures of metabolic health. Diet and physical activity will then be~     monitored over a four day period using diet and activity diaries, and an activity monitor.~     The findings from this study will contribute to the evidence base on how subject~     characteristics influence body composition and inform on the design of future human studies~     on body composition methodology.~   "
30451|NCT02658526|"~     The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and~     animal studies showed a risk for treatment with anesthesia in the developmental brain.~     Furthermore, stress is also an important risk factor for cognitive impairment. Therefore,~     the investigators want to investigate in a clinical prospective cohort study the role~     anesthesia and surgery on different cognitive parameters and self-controling mechanisms in~     children under 3 years.~   "
30452|NCT02658513|"~     Recently published European guidance recommends the evaluation of the radiation dose to the~     bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods~     described in these guidelines require serial blood samples to be taken from the patient,~     followed by a sophisticated analysis to determine the radiation dose. However, radiation~     risk assessments carried out locally have indicated that a relatively high radiation~     exposure will be received by the operator taking the blood samples, which may prohibit this~     procedure being carried out routinely.~      The radiation dose to the operator will be lowered if the duration of the blood sampling~     procedure were reduced. The investigators hypothesize that the use of a lancet and pipette~     to collect blood from the finger tip will greatly reduce the time spent in proximity to the~     patient, significantly reducing the operator exposure and allowing this procedure to be~     performed routinely. The proposed method is also less invasive for the patient compared to~     the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project~     using radioiodine diluted to the expected concentration in blood has indicated that using~     very small volumes of blood (such as from a lancet) does not compromise the accuracy of the~     dosimetry measurement when compared to large-volume standard blood samples.~      The primary aim of this study is to investigate whether sampling a small volume of blood~     using a lancet and pipette can replace standard intravenous blood samples for bone marrow~     dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests~     will determine whether there is a significant difference between the doses calculated using~     each blood sampling method. In addition, the investigators will measure the radiation~     exposure received by the operator during each procedure using Electronic Portable~     Dosimeters. The results of these measurements will be used to quantify the reduction in~     operator radiation exposure afforded by the new technique.~   "
30453|NCT02658500|"~     This study evaluates the early infant feeding in the infant intestinal microecology and the~     long term health. 300 healthy term newborns were involved into the study on its first stage.~     Depending on the type of feeding the infants were divided into 3 groups with random~     allocation to one of the formula feeding groups: the group A included 100 infants consuming~     the formula supplement with superior quality whey protein, the group B -100 infants fed with~     a standard formula, and the group C -100 infants who were breastfed.~   "
30454|NCT02658487|"~     This phase II trial studies how well vosaroxin and cytarabine work in treating patients with~     untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
30455|NCT02658474|"~     The purpose of this study is to determine whether group based Acceptance and Commitment~     Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care~     setting among patients with chronic pain.~      Hypothesis:~      i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life~     (HRQOL) in patients with chronic pain than treatment in a primary care setting.~      ii) The improvement in pain and HRQOL is mediated through an increased degree of pain~     willingness and involvement in activities.~      iii) Improvement of pain and HRQOL after the two treatments is associated with demographic,~     psychosocial and somatic characteristics.~   "
30456|NCT02658461|"~     This prospective, non-interventional time and motion study will evaluate the costs of~     healthcare resource utilization associated with the administration of trastuzumab~     (Herceptin) SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical~     study MO22982 (NCT01401166/PrefHer).~   "
30457|NCT02658448|"~     The purpose of this study is to determine whether GTx-024 is safe and effective in the~     treatment of stress urinary incontinence in postmenopausal women.~   "
30458|NCT02658435|"~     The study aims to provide evidence of retinal safety to support the use of tafenoquine as a~     potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax)~     malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be~     conducted as a single masked, randomized, placebo-controlled, parallel group design. It will~     assess retinal changes from baseline using spectral domain optical coherence tomography~     (OCT) and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy~     volunteers (participants). A placebo control group will be used to compare the results in~     the TQ group. Interim analysis will be conducted after completing 100 out of 300~     participants in TQ group and 50 out of 150 participants in matched placebo.~   "
30459|NCT02658422|"~     This study is conducted to determine whether the test product (GW483100 10 mg containing~     montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference~     montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under~     fasting conditions. This is an open-label, balanced, randomized, single dose, two-way~     crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete~     the study. Each subject enrolled will participate in two treatment periods separated by a~     washout period of at least 7 days and no more than 14 days between dosing occasions. Total~     duration in the study for each subject will be approximately 7 weeks from screening to the~     subject's last visit.~   "
30460|NCT02658409|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase~     III Study.~   "
30461|NCT02658396|"~     This research study is studying a combination of targeted therapies known as GO-203-2C and~     bortezomib as a possible treatment for multiple myeloma that has either progressed or not~     responded to treatment.~   "
30462|NCT02658383|"~     Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many~     households use traditional cookstoves to meet these energy needs, which can result in~     extremely high indoor air pollution concentrations. Indoor air pollution from biomass~     combustion accounts for an estimated 3.9 million premature deaths per year, representing~     about 4.8% of the global disease burden. Improved stove designs have the potential to~     substantially reduce indoor air pollution exposures. However, there are few randomized~     intervention trials, and previous stove intervention studies have been plagued by low~     improved stove adoption and sustained use, severely limiting interpretations of these~     studies. This research proposes to conduct community surveys and in-depth interviews among~     Honduran cookstove users to gain insight into the complex pathways surrounding barriers to~     and predictors of sustained improved cookstove adoption (among the target population for the~     proposed intervention). This information will be used to conduct and enhance a randomized~     improved cookstove intervention among 300 Honduran families, incorporating qualitative and~     quantitative measures of cookstove use and measuring pre- to post-intervention changes in~     pollutant exposures and subclinical indicators of cardiovascular health.~      The primary goals are twofold:~        -  To incorporate community-engaged approaches throughout all aspects of the research~        -  To maximize sustained stove use (thereby maximizing the health impact of the~          intervention) to achieve valid exposure-response estimates.~      Both objectives utilize innovative strategies to fill knowledge gaps. The research team will~     build upon previous studies in Latin America that have focused on identifying and validating~     appropriate field techniques for exposure and health assessments in rural areas of~     developing countries.~      In summary, the proposed project will provide insight regarding barriers/predictors of~     sustained cookstove adoption, an issue impeding research in this field; assess the~     relationship between stove use and indicators of cardiovascular health, a substantial and~     quickly growing disease burden in developing countries; and result in a more comprehensive~     and valid assessment of the impact of a cookstove intervention.~   "
30463|NCT02658370|"~     The purpose of this pilot study is to investigate feasibility and patients´ assessment using~     an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console)~     for patients with rheumatoid arthritis.~   "
30467|NCT02658318|"~     In cleft surgery there is no current general agreement on the treatment strategy of patients~     with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on~     the treating physician or the hospital facility. Literature regarding peri- and~     postoperative complications in the target population are lacking.~      The investigators aim to retrospectively review the charts of all cleft patients, both PRS~     and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015.~     The incidence of peri- and postoperative complications, with a specific focus on respiratory~     complications, will be examined. The value of demographic, surgical and postoperative~     parameters will be examined as potential risk factors for the development of complications.~   "
30468|NCT02658305|"~     Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic~     surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic~     surgery, which is less often used.~      The aim of this study was to compare postoperative outcome of transoral versus transbuccal~     bicortical screw placement during orthognathic surgery.~      This study comprises an academic, retrospective, monocentric study in which the charts of~     orthognathic patients operated between January 2010 and December 2012 were retrospectively~     reviewed. Postoperative complications were registered. Demographic, dental and surgical~     parameters are examined as potential risk factors for the occurence of postoperative~     complications.~   "
30469|NCT02658292|"~     A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy~     and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis~   "
30470|NCT02658279|"~     The purpose of this study is to test if the study drug called pembrolizumab could control~     the growth or shrink the cancer but it could also cause side effects. Researchers hope to~     learn if the study drug will shrink the cancer by half, or prevent it from growing for at~     least 6 months. Pembrolizumab is an antibody that targets the immune system and activates it~     to stop cancer growth and/or kill cancer cells.~   "
30471|NCT02658266|"~     Adults with complex congenital heart disease have impaired muscle function compared both to~     health controls and patients with lesions classified as simple. There is only one study~     assessing the effects of resistance training in patients palliated with Fontan procedure.~     The hypotheses of the present study is that home based resistance training will improve~     muscle function in adults with different complex congenital hear diseases.~   "
30472|NCT02658253|"~     The primary objective of the study is to evaluate the safety of 3 different dosages (20µg -~     50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either~     with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and~     Burkinabe adults.~      The safety and the tolerability of the vaccine will be assessed on the rate of solicited and~     unsolicited events/reactions The safety profile will included local and systemic~     reactions/events as well as the biological safety, based on a clinically significant change~     of the baseline value of the main biological criteria~   "
30473|NCT02658240|"~     This randomized, controlled, observer-blinded study clinical trial was designed to evaluate~     ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular~     infiltration with ropivacaine for postoperative pain management after total hip~     arthroplasty.~   "
30474|NCT02658214|"~     Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following~     indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ~     cancer.~   "
30475|NCT02658201|"~     In haematological malignancy and in immunocompromised patients, constipation is a common~     symptom caused by a number of factors during treatment. In current clinical practice, an~     abdominal radiograph is the first imaging investigation for constipation and non specific~     abdominal pain to support or exclude the clinical suspicion. Children are more sensitive to~     radiation induced adverse effects especially in the thyroid gland and bone marrow.~     Immunocompromised patients are at risk of developing a second malignant neoplasm. MRI is an~     alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on~     abdominal MRI has always been challenging primarily because of bowel motion and a long~     acquisition time for standard T1 and T2 weighted sequences. Recent development of an~     ultrafast 2 dimensional FIESTA sequence developed by GE (General Electric) Healthcare based~     on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages:~     motion insensitivity ( does not interfere with peristalsis), sharp edge definition and~     higher contrast when compared with the standard SSFSE pulse sequence. FIESTA is well suited~     for abdominal imaging as it produces motion- free images, allowing clear delineation of~     intra-peritoneal and retroperitoneal anatomy and is capable of depicting the vascular~     anatomy and lymph-adenopathy.There is a wide spectrum of diseases which could cause~     abdominal pain in our study group with constipation being the most common cause but MRI~     could potentially detect more serious bowel-related chemotherapy induced complications such~     as typhlitis, pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal~     abscess, which would not be apparent on abdominal radiograph.~   "
30476|NCT02658188|"~     The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin~     enacarbil) for long-term treatment of restless legs syndrome patients.~   "
30477|NCT02658175|"~     An Open-Label Study of Volanesorsen (IONIS 304801) Administered Subcutaneously to Patients~     with Familial Chylomicronemia Syndrome (FCS)~   "
30478|NCT02658162|"~     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in~     patients who will be recipients of a donation after brain death (DBD) donor kidney.~   "
30479|NCT02658149|"~     The primary objective of this study is to examine whether there is a difference in the level~     of resting pain following total hip arthroplasty with an anterior approach with use of a~     psoas compartment block versus a local periarticular anesthetic infiltration~   "
30480|NCT02658136|"~     Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients~     remains severely reduced post-implant. While the effect of right ventricular (RV) failure~     early after pump implantation, and its effect on outcome has been extensively studied, the~     effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely~     described. Thus the purpose of this study is to examine RV function and the association to~     exercise capacity in CF-LVAD patients.~   "
30493|NCT02657967|"~     This study is an observational study to determine predictors of sudden cardiac death or~     appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be~     followed for 36 months for the occurrence of sudden cardiac death~   "
30481|NCT02658123|"~     Preventing complications and readmission after ostomy surgery will decrease the cost of~     healthcare, improve patient safety, reduce the cost of durable medical equipment required by~     ostomates, ensure continued specialized care is available, and potentially improve both~     short and long-term quality of life (QOL) for patients by reducing morbidity and mortality~     associated with ostomy surgery. The purpose of this study is to measure the effectiveness of~     patient centered interventions/care pathways and to determine the impact on healthcare~     utilization, 30-day hospital readmissions, and QOL.~   "
30482|NCT02658110|"~     The proposed study aims to determine the metabolic and appetite responses to standard~     breakfast and lunch meals whilst altering the timing of whey protein supplementation.~     Currently, the designs implemented in many studies mean that it is unclear whether an~     optimum time for whey protein consumption exists in order to promote the greatest acute~     health benefits. A number of studies have investigated the effects of whey protein when~     consumed as a preload to a subsequent meal, whilst benefits have also been shown when whey~     protein is ingested with a meal. The proposed study will therefore investigate strategies of~     whey protein supplementation that vary in their practical applicability, using meals that~     reflect regular eating behaviours throughout the population in a sample of overweight/obese~     individuals.~      Findings from this study may provide important information regarding the efficacy of whey~     protein supplementation before, during and after a composite meal, and its effect on the~     handling of a subsequent mixed-macronutrient meal.~   "
30483|NCT02658097|"~     This study looks at patients with advanced lung cancer. Participants in this study will be~     randomized into two groups. The first group will have radiation plus a drug (pembrolizumab).~     The second group will have only the drug (pembrolizumab). Tumors of participants will be~     measured to see if the addition of radiation changes the growth of the tumor compared to the~     drug alone.~   "
30484|NCT02658084|"~     The study proposes to evaluate the safety and efficacy of the combination of trastuzumab~     emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.~   "
30485|NCT02658071|"~     Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and~     their axons slowly die with visible changes at the optic nerve head (cupping). Without early~     diagnosis and effective treatment or with delayed treatment decrease of visual acuity or~     blindness become.~      In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are~     found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material~     inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression~     raise. The exfoliation material is found on the surface of the lens capsule with frequent~     developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP)~     decrease.~      Some recent study have found decreasing ocular volume variation associated to IOP~     fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our~     study we want see if it's the same thing in pseudoexfoliation glaucoma patients.~   "
30486|NCT02658058|"~     Traditionally, spinal anesthesia is performed using the palpation of bony landmark to~     identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has~     become an increasingly popular procedure among anesthesiologists to guide neuraxial~     blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are~     limited to a midline approach using a transverse median views. The parasagittal oblique view~     consistently offers better ultrasound view of the neuraxis compared to the transverse median~     view. However, it is still not evident whether these superior parasagittal oblique views~     will lead to an easier paramedian needle insertion. In the literature, there are no studies~     directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO)~     view, the US-guided midline approach using the transverse median view, and the conventional~     landmark midline approach to perform spinal anesthesia in the elderly patients, in~     particular for the teaching of novice anesthesia residents.~   "
30487|NCT02658045|"~     The trial shall assess the accuracy of the Oxitone® 1000 in measuring oxygen saturation, by~     comparing its measurement to reference devices: non-invasive SpO2 and pulse-rate values~     determined by a pulse oximeter. A total of approximately 40 subjects: 20 healthy and 20 COPD~     (chronic obstructive pulmonary disease ) patients will be enrolled. These subjects will be~     enrolled at the medical center pulmonary department and will be recruited from the clinic~     patient base. The subjects will be represented by male and female adults who optimally cover~     a range of ethnic backgrounds (skin pigmentation). All testing will be performed in~     singleton and in a blinded fashion. This study will be conducted with the approval of the~     medical center ethics committee.~      This is a comparison open study with no subject follow-up.~   "
30488|NCT02658032|"~     The purpose of this study is to test the efficacy of two separate, sequential interventions~     to promote tobacco cessation/reduction in individuals recently identified with lung nodules.~     Each intervention will be compared to standard of care. The first intervention will be a~     personalized message intervention, the second intervention will consist of a~     biofeedback-based intervention.~   "
30489|NCT02658019|"~     This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced,~     unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic~     efficacy in patients with unresectable hepatocellular carcinoma (HCC). The primary endpoint~     is disease-control rate (DCR) defined as the proportion of patients achieving a best overall~     response of either a complete response (CR), partial response (PR) or stable disease (SD)~     (that is maintained for at least 8 weeks).~      Secondary endpoints include progression-free survival (PFS), overall survival (OS),~     objective response rate (ORR), duration of response (DOR), and toxicity profile of~     Pembrolizumab. The investigators will also evaluate the expression levels of Programmed~     death-ligand 1 (PD-L-1) in tumor tissue, as well as serum titers of hepatitis B or C in~     patients with hepatitis B or C, respectively, for whom specimens are available.~   "
30490|NCT02658006|"~     The purpose of this prospective observational cohort study is to evaluate multimodal~     monitoring technologies in the perioperative care of cardiac surgical patients. Right~     ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic~     ultrasonography will be studied for their ability to detect and predict complications such~     as right ventricular failure, renal failure and respiratory failure.~   "
33793|NCT02614833|"~     The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the~     active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in~     patients with hormone receptor-positive metastatic breast cancer.~   "
30494|NCT02657954|"~     Cognitive impairments are present in up to 80% of homeless individuals, and may contribute~     to homelessness in Operation Enduring Freedom / Operation Iraqi Freedom / Operation New Dawn~     (OEF/OIF/OND) Veterans. The investigators propose to investigate these issues in homeless,~     treatment-seeking returning Veterans, who arguably face multiple potential barriers to~     recovery and reintegration, and with whom there is the greatest opportunity to prevent~     long-term homelessness. The investigators plan to conduct a 15-week randomized controlled~     trial of an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention vs.~     an education control condition to examine the effects of cognitive rehabilitation in this~     Veteran population. The investigators expect CCT-associated improvements in cognition and~     functional skills and generalization to reduced levels of disability, along with improved~     community reintegration outcomes. By attending to and treating cognitive impairments, the~     investigators can potentially prevent future homelessness and its negative health~     consequences, resulting in both healthcare cost savings and improved quality of life for~     Veterans.~   "
30495|NCT02657941|"~     People with severe mental illness have an increased risk of somatic comorbidities such as~     metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce~     an increased risk of early mortality, mainly because of cardiovascular diseases.~      These high cardio-metabolic risks result of several factors such as lack of access to~     medical care, a poor and unbalanced nutrition, physical inactivity and smoking but they are~     also exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed~     to treat their psychiatric disorder.~      These prevention and awareness interventions in lifestyle are most often implemented in~     ambulatory stabilized patients. Also weight gain occurs in the early months of treatment.~     The therapeutic education program evaluated in this study seeks to potentiate the~     effectiveness of these preventive measures through early awareness in hospitalized patients.~      Finally, this study aims to compare the efficacy of two early and short programs on health~     behavior: first a program inspired by motivational interviewing and behavioral psychotherapy~     and secondly an exclusively educational program (information, formative assessment).~   "
30496|NCT02657928|"~     This phase II trial studies how well ribociclib and letrozole work in treating patients with~     estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial~     cancer that has returned (come back) after a period of improvement. Ribociclib may stop the~     growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are~     estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of~     estrogen made by the body and this may stop the growth of tumor cells that need estrogen to~     grow. Giving ribociclib together with letrozole may be an effective treatment in patients~     with ovarian, fallopian tube, primary peritoneal, or endometrial cancer.~   "
30497|NCT02657915|"~     The primary objective of the study is to assess full-field visual evoked potential (FF-VEP)~     latency in subjects who were enrolled in Study 215ON201 (NCT01721161) 2 years (+ 4 months)~     after the last study visit. The secondary objective is to assess clinical progression and~     severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled~     in Study 215ON201 2 years (+ 4 months) after the last study visit. No study drug dosing is~     planned for this study.~   "
30498|NCT02657902|"~     The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is~     associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric~     fractures.~   "
30499|NCT02657889|"~     This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with~     niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic~     triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)~   "
30500|NCT02657876|"~     This study is designed as a prospective, multicenter, open-label trial focused on assessing~     the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic~     foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care~     comparator is not included in this first-in-human study. Targeted enrollment for this study~     is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers.~     Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single~     identified study DFU following a 6-10 day run-in period. Any subjects requiring additional~     treatment will receive protocol-defined dressings through study session 7 as necessary.~     Enrollment will occur with a minimum of one week between each subject.~   "
30501|NCT02657863|"~     This study is being conducted to collect and analyze biospecimens (blood and urine) and~     clinical data from patients with prostate cancer as well as healthy volunteers to better~     understand the differences between cancer cells and normal tissues with the goal of~     developing a better way to detect and track the treatment of prostate cancer.~        -  These samples are being collected to conduct research to accomplish the goal of~          improving cancer therapies, biomarkers, and hopefully lead to more effective treatment~          of prostate cancer.~        -  The samples that you are providing as a patient with prostate cancer will be used in~          future research.~        -  Your biospecimens will be compared to the cancer and normal volunteer specimens from~          other participants to understand genetic differences between normal and cancer cells.~          Genetic material, including DNA and RNA, will be obtained from samples, stored, and~          used for evaluation.~        -  Clinical information and samples will be collected and stored for ongoing research.~          This is a necessity because improved diagnosis, prognosis and treatment of cancer in~          the future depend upon the ongoing analysis of basic research findings and clinical~          outcomes. This type of research may improve the lives of future patients with cancer.~      Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy~     with radiation may join.~   "
30511|NCT02657733|"~     Respiration rate is a critical vital sign that provides early detection of respiratory~     compromise and patient distress. Continuous monitoring of respiration rate is performed in~     patients under different clinical conditions, including post-surgery or different~     respiratory diseases. Clinician observation, pulse oximetry, and capnography are used~     individually or in combination to monitor ventilation during sedation and on post-surgical~     patients. The American Society of Anesthesiologists mandates the monitoring of respiration~     by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia.~     Other techniques for respiration rate measurement include different technologies such as~     acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2~     and RRa under certain respiratory conditions.~   "
30502|NCT02657850|"~     Cancers located in the upper aerodigestive tract of the head and neck region present unique~     management challenges due to the crucial functions in this anatomic region along with its~     anatomic density. As such, cancers themselves and the actual treatment can affect these~     functions. Of these, the ability to effectively and safely transport a swallow bolus from~     the oral cavity to the esophagus is particularly important. This consideration has in fact~     been a major source of debate regarding the optimal management for head and neck cancers as~     both oncologic-effective and function-preserving therapies are desired. Accomplishing this~     therapeutic goal has been elusive and can be attributed to a lack of tools that effectively~     and longitudinally evaluate swallow function over the course of a treatment and in~     follow-up. As such, investigators surprisingly lack a clear understanding of the natural~     history of treatment -related swallow dysfunction (dysphagia) regardless of the treatment~     modality. As such, understanding the prevalence of this significant complication is in fact~     not well established. Understanding the true prevalence of treatment-related dysphagia is in~     fact critical to establish as it will help guide decisions as to whether or not treatment~     strategies require modification including de-intensification of treatment that is receiving~     considerable attention for favourable prognosis patients associated with the human~     papillomavirus (HPV).~      To address this problem, winvestigators hypothesize that the quantitative and validated~     patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an~     effective tool to longitudinally measure swallow function to determine the natural history~     of head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well~     suited for longitudinal evaluation of swallow function as it quantifies various aspect of~     patient-perceived swallow function in contrast to other swallow PROs that measure the impact~     of swallow function on quality of life domains. To determine the two-year prevalence of~     dysphagia, investigators will employ a multi-institution prospective study design using our~     Oncospace® web-portal to facilitate secure prospective data curation and analysis that will~     include evaluations before, during and following standard of care definitive cancer~     treatment for a total of 36 months in the follow-up period.~   "
30503|NCT02657837|"~     The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function~     that is considered a research tool in Canada as the device used to measure it is not~     approved by Health Canada. The study will assess lung function in patients undergoing~     routine lung function testing for clinical indications (Cystic Fibrosis and Other~     Respiratory Diseases). In addition, healthy controls of different ages will be asked to~     perform this lung function test to gain reference data that can be used to interpret LCI in~     patients with lung disease.~   "
30504|NCT02657824|"~     Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to~     the patients, admitted to the emergency department with shortness of breath. The~     investigators aimed to investigate correlation between LVEF and 4 different mitral valve~     movements which alternate to the classical LVEF assessing methods and evaluate these methods~     can be used or not in the emergency department.~   "
30505|NCT02657811|"~     Embryo culture and selection has been a continuous challenge in evolution since the birth of~     In Vitro Fertilization (IVF). Traditionally, embryo quality and its presumed suitability for~     transfer were assessed based on morphologic features. However, the consensus as to the~     optimal time points for embryo assessment and as to 'preferable' characteristics have been~     challenging. Alongside this has been the challenge of achieving balance between multiple~     points of assessment, yet stabilizing the embryo environment for growth. In standard~     incubation, each new morphological assessment of embryos in culture theoretically creates an~     additional disruption to culture.~      Most recently, time-lapse incubators (TLI) have been introduced as a novel embryo culture~     system attempting to limit culture disturbances. These incubators have been integrated with~     digital imaging, allowing for a substantial limitation in embryo handling and environmental~     disturbances. They have also introduced new morphokinetic parameters to embryo assessment~     and to optimizing selection of embryos. Thus far, a limited number of studies have examined~     the clinical outcomes and value of time lapse monitoring systems versus the more ubiquitous~     incubators (e.g. multichamber) for reproductive outcomes. In particular, the isolated value~     of morphokinetics in embryo assessment and of this new stable culture environment in TLI are~     still in question.~      The objectives of this study are to prospectively assess and compare fertility outcomes when~     embryos are cultured in the TLI system versus more traditional bench incubators (BI). We~     will specifically assess the added value of the closed and isolated TLI compared to BI on~     reproductive outcomes, as well as the value of morphokinetic grading in IVF.~   "
30506|NCT02657798|"~     This study will investigate the biological pathways involved in anti-depressant resistance~     that increase risk of cardiovascular disease in people with depression.~   "
30507|NCT02657785|"~     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high~     effective in primary central nervous system lymphoma (PCNSL) patients.~   "
30508|NCT02657772|"~     The purpose of this study is to assess the safety and efficacy rates of the treatment of~     small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are~     a type of platinum coils used to occlude aneurysms.~   "
30509|NCT02657759|"~     This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on~     lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate~     hypercholesterolemia.~   "
30510|NCT02657746|"~     Background: High blood pressure (BP) is the leading attributable risk for cardiovascular~     disease (CVD). In rural South Asia, hypertension remains to be a significant public health~     issue with sub-optimal rates of case finding and management. The goal of the full-scale~     study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care~     strategies on lowering blood pressure among adults with hypertension in rural communities in~     Bangladesh, Pakistan, and Sri Lanka.~      Methods/Design: The mixed-methods, stratified cluster randomized controlled trial~      Intervention: The multi-component interventions (MCI) is comprised of all the following five~     components: 1) home health education (HHE) by government community health workers (CHWs),~     plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general~     practitioner (GP) using a checklist, plus 3) training public and private providers in~     management of hypertension and using a checklist, plus 4) designating hypertension triage~     counter and hypertension care coordinators in government clinics, plus 5) a financing model~     to compensate for additional health services and provide subsides to low income individuals~     with poorly controlled hypertension.~      Usual care: Will comprise existing services in the community without any additional~     training.~      Participants: The trial will be conducted on 2550 individuals aged 40 years or older with~     hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive~     therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550~     individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg)~     will be selected, 14 from each community, to investigate the effect of MCI on results from~     ambulatory BP monitoring.~      Qualitative component: Stakeholders including policymakers, district managers, and community~     health workers, GPs, hypertensive individuals and family members in the identified clusters~     will be surveyed.~      Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24~     months post randomization. The cost effectiveness outcome is the incremental cost of MCI per~     unit reduction in BP over the two year time period and in terms of incremental cost per CVD~     DALYs averted.~   "
30538|NCT02657382|"~     The purpose of this study is to evaluate the blood flow to the heart during stress and~     assess changes in blood flow after psychological treatment in participants with coronary~     artery disease. The aims of the study are to assess the effects of heart rate variability~     (HRV) biofeedback (versus usual care) on global and regional myocardial blood flow (MBF),~     peripheral vascular function, and autonomic changes during mental stress.~   "
30512|NCT02657720|"~     Respiration rate is a critical vital sign that provides early detection of respiratory~     compromise and patient distress. Continuous monitoring of respiration rate is performed in~     patients under different clinical conditions, including post-surgery or different~     respiratory diseases. Clinician observation, pulse oximetry, and capnography are used~     individually or in combination to monitor ventilation during sedation and on post-surgical~     patients. The American Society of Anesthesiologists mandates the monitoring of respiration~     by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia.~     Other techniques for respiration rate measurement include different technologies such as~     acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2~     and RRa under certain respiratory conditions.~   "
30513|NCT02657707|"~     A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and~     effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with~     the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in~     patients with elevated risk for adverse events following carotid endarterectomy.~   "
30514|NCT02657694|"~     REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is~     observing and collating the treatment course, safety profile, and outcomes of patients~     around the world who are choosing to self import generic versions of the Direct Acting~     Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and~     Bangladesh.~   "
30515|NCT02657681|"~     This is a randomized sham-controlled double-blind study to test the hypothesis that~     transcranial static magnetic field stimulation (tSMS) of the motor cortex improves~     levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will~     receive real tSMS treatment, the other half will receive sham treatment (placebo).~   "
30516|NCT02657668|"~     The study was quasi-experimental including patients in two intervention and control groups.~     Three measurements were done: pretest, post-test, and a two-months follow-up. The study~     population included patients with irritable bowel syndrome(diagnosed by specialists and~     based on the criteria of Rome III), who referred to a general Hospital. Fifty two irritable~     bowel syndrome patients were selected and assigned to two experiment (26 cases) and control~     (26 cases) groups. The criteria below were considered in selection of patients.~      Inclusion criteria: 1) Patients should not have participated in other psychological~     interventions concurrently; 2) Participants had not reported diagnosis of non-functional~     gastrointestinal illnesses. 3) Women patients had not been in pregnancy; 4) Participants had~     not met diagnosis of schizophrenia and bipolar disorders.~      Exclusion criteria: Three or more absences in the group sessions Co-variate variables: 1)~     demo-graphical variables (age, birth order, and education); 2) clinical variables (global~     psychological status, mind-body attribution, and duration of disease).~   "
30517|NCT02657655|"~     Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim~     of this study is to investigate the impact, validation, and usability of the Kinesia 360~     system.~   "
30518|NCT02657642|"~     Background : The transitional care OMAGE-P combines three best practices recommendations~     from the French National Authority for Health (HAS) (i) a comprehensive review of diagnosis~     and treatments (ii) a standardized medical report and (iii)a patient education program~     specifically designed for older people with multiple chronic conditions and polypharmacy.~     This transitional care is implemented in a pilot general hospital with the support of French~     ministry of Health and Regional Agency for Health of Ile de France . The aim of the study is~     to assess the impact of the OMAGE P transitional care on the readmissions of non demented~     older people aged 75 years and over within the 3 months following their discharge to home~     and its cost-effectiveness .~      Study Population: non demented people aged 75 years and over admitted in emergency (ie via~     an emergency department ) in the participating units~      Study design:~      Observational prospective monocentric non randomized comparative study Exposed patients:~     eligible patients admitted in participating units and who does not oppose to the collection~     of his personal data. The hospital physician in charge will conduct the comprehensive review~     of diagnosis and treatments and will do the standardized medical report. Patient education~     program will be conduct by the hospital physician and the OMAGE nurse during the~     hospitalization (two sequences) and during 2 to 4 home visits in the month following patient~     's discharge from hospital.~      Non exposed patients: eligible patients from the usual care arm of the RCT OMAGE. To ensure~     that risk for emergency readmissions is not different between exposed and non exposed , the~     rate of emergency readmissions of non exposed group will be compared with the one of~     eligible patient admitted in the participating units in 2013 and 2014.~      Setting: General hospital of Eaubonne : geriatric department (acute geriatric unit,~     rehabilitation unit , geriatric mobile unit ) and internal medicine department Number of~     subjects to be included: 484 (242 in each arm). The data for the 242 non exposed patients~     are still available, 242 patients has to be included in the exposed group~   "
30519|NCT02657629|"~     The purpose of the study is to determine if a continuous feeding regimen as compared to an~     intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic~     left heart syndrome (HLHS) after stage 1 procedures.~   "
30520|NCT02657616|"~     The central questions of the study can be summarized as follows:~      What stroke / death rates are the result of the use of the following treatment strategies:~     no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs),~     anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic~     complication rates resulting from the use of these treatment strategies? What heavy bleeding~     rates resulting from the defined management strategies? The analysis is based on a data set~     of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the~     reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation~     time per patient is 12 months.~      Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.~      The aim of the study is to compare clinical outcomes between the different treatment~     strategies (frequency of events and time to first event). The influence of alternative~     treatment strategies is measured on the basis of three different methodological approaches:~     unadjusted comparison of event council and time to first event between the defined patient~     groups; matched-pair comparison (propensity score matching) between the different groups of~     patients (treatment strategies) and multivariate analysis using time to event (Cox~     proportional hazards model) as the dependent variable.~   "
30539|NCT02657369|"~     The primary purpose of the study is to evaluate objective response rate ([ORR]: complete~     response [CR] and partial response [PR]) by investigator review in participants with~     anaplastic thyroid cancer (ATC) treated with lenvatinib.~   "
30540|NCT02657356|"~     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in~     patients with connective tissue disease-associated pulmonary arterial hypertension to~     determine the recommended dose range and evaluate the change from baseline in 6-minute walk~     distance (6MWD) following 24 weeks of study participation.~   "
31349|NCT02646774|"~     The objective of this study is to evaluate the efficacy and safety of intravenous micafungin~     for the treatment of proven or probable fungal infections caused by Aspergillus sp.~     (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.~   "
30521|NCT02657603|"~     This is a single center, randomized, blinded trial in healthy volunteers. The volunteers~     will receive bilateral placement of the new catheter corresponding to the adductor canal.~     Each volunteer will have a catheter placed in the adductor canal in both legs. The catheters~     are randomized to be placed either in the long-axis or short-axis plane of the adductor~     canal. Both catheters will be injected with local analgesics (LA). Allocation will be~     blinded to the volunteer and the investigator assessing sensory function. The volunteers~     will be sent home with the catheter in situ and return the following day. Injection with LA~     is repeated and sensory function is tested again. Furthermore catheter position is~     determined with ultrasound during injection. If sensory function is not affected by~     injection of LA then the catheter is visualized with ultrasound and repositioned followed by~     a second injection of LA and subsequent assessment of sensory function~   "
30522|NCT02657590|"~     This study aims at recording cardiac arrhythmias in patients after open heart surgery. The~     arrhythmias will be monitored during the entire first postoperative period, till six weeks~     after surgery.~   "
30523|NCT02657577|"~     WIC is a governmental program that provides healthy foods, nutrition education and referrals~     to other health and social services. With the goal of applying for a future grant to expand~     the dissemination of SmartLoss® within the WIC program, feedback (via focus groups) from the~     WIC employees and WIC recipients must be solicited to better understand the burden and~     barriers of integrating these kinds of programs and with WIC participants.~   "
30524|NCT02657564|"~     This study evaluates the changes of renal function after taking bowel cleansing agent~     polyethylene glycol for elective colonoscopy.~   "
30525|NCT02657551|"~     This research study is studying a targeted therapy as a possible treatment for thyroid~     cancer. A targeted therapy is a type of treatment that uses drugs or other substances to~     identify and attack specific types of cancer cells with less harm to normal cells.~      - The name of the study intervention involved in this study is regorafenib.~   "
30526|NCT02657538|"~     The aim of this study is to validate a near-infrared light transillumination device~     (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare~     it with the established diagnostic methods (visual examination and bitewing radiography).~     The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.~   "
30527|NCT02657525|"~     The purpose of this study is to investigate the demographic characteristics, clinical~     features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease~     prognosis and its economic burden.~   "
30528|NCT02657512|"~     Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X.~     Bleeding events related to rivaroxaban are the consequence of physiopathologic,~     pharmacokinetic issues or poisoning. Few results are available on the use of activated~     charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that~     activated charcoal can reduce significantly exposition to apixaban (a direct oral~     anticoagulant of the same class). The objective of this study is to evaluate the effect of~     activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open~     trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects.~     Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated~     charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.~   "
30529|NCT02657499|"~     This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid~     expansions on access to and utilization of community health center (CHC) services. Building~     on the investigators prior work that developed a robust community-based research~     infrastructure within the OCHIN community health information network, the investigator will~     utilize linked electronic health record data from the OCHIN network of >400 CHC clinics in 8~     states that expanded Medicaid coverage and 8 states that did not expand.~   "
30530|NCT02657486|"~     The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer~     tumors that are confined to the lining of the bladder.~   "
30531|NCT02657473|"~     The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS)~     once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint~     is a reduction of exacerbations of the disease during the treatment period. Next to this~     parameter the investigators expect to show a significant beneficial effect on lung function~     parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.~   "
30532|NCT02657460|"~     The study is to investigate the anticancer effect and the related immunological mechanism of~     MTX-ATMPs in the treatment of malignant pleural effusion.~   "
30533|NCT02657447|"~     This study is a phase I, open label, randomized study to assess pharmacokinetics,~     biodistribution and radiation dosimetry of 177Lu-DOTA-HH1 (Betalutin®) radioimmunotherapy in~     patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety,~     toxicity and efficacy of Betalutin and pre-dosing.~   "
30534|NCT02657434|"~     This is a randomized, Phase III, multicenter, open-label study designed to evaluate the~     safety and efficacy of atezolizumab in combination with cisplatin or carboplatin +~     pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in~     participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible~     participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab +~     Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed).~     The study will be conducted in two phases: Induction Phase and Maintenance Phase.~   "
30535|NCT02657421|"~     The purpose of this single-arm observational study is to observe and document clinical~     outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc~     disease or degenerative scoliosis, and report the rate of adverse events of interest through~     the 24 months follow-up visit.~   "
30536|NCT02657408|"~     The main objective of this study is to investigate safety, tolerability, pharmacokinetics~     and pharmacodynamics of oral BI 1026706, administered for 4 weeks, on~     lipopolysaccharide-induced inflammatory response in healthy male smokers.~   "
30537|NCT02657395|"~     Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental~     root coverage procedures.~   "
30541|NCT02657343|"~     Participants that have breast cancer that has spread to other parts of the body, is positive~     for a protein called HER2, and has not responded to standard treatment. This research study~     is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a~     possible treatment for this diagnosis.~   "
30543|NCT02657317|"~     This is a research study of an interdisciplinary pain management program for U.S. military~     veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom [OIF],~     Enduring Freedom [OEF], New Dawn [OND]) presenting with chronic musculoskeletal pain related~     to military service with comorbid depression and/or posttraumatic stress disorder [PTSD]~     symptoms and/or mild traumatic brain injury. This study will test the efficacy of an~     interdisciplinary pain program compared to treatment as usual in the Veterans Health~     Administration on pain-related disability, opioid medication use, and pain coping.~   "
30544|NCT02657304|"~     Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed.~     SA can increase the occurrence of cardiovascular, endocrine and metabolic events~     (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of~     SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP~     is a significant problem where a significant rate of rejection and abundance after 6 months~     of treatment.~   "
30545|NCT02657291|"~     Patients for upper limb surgeries who are candidates for infraclavicular block will be~     screened. Two techniques of infraclavicular block will be compared. Measured outcomes are~     performance times, block onset times, patient satisfaction, quality of block, and~     requirement for supplementary analgesia.~   "
30546|NCT02657278|"~     Aim: To determine whether the lactate threshold during CPET is influenced by the presence of~     haemodynamically significant PAD.~      Assumption: Correction of haemodynamically significant PAD results in an increased LT,~     measured by CPET.~      Design: Prospective study Population: Thirty patients scheduled to undergo surgical or~     percutaneous treatment of iliofemoral arterial disease for intermittent claudication.~   "
30547|NCT02657265|"~     This study will compare two standard treatments in acute stable traumatic vertebral~     fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:~        1. SpineJack® system~        2. Conservative Orthopedic Management consisting of brace and pain medication.~   "
30548|NCT02657252|"~     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%~     hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only~     adult women with reticular veins on the side of the thighs and mild venous insufficiency~     (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.~   "
30549|NCT02657239|"~     MOVE UP is a weight management program for adults 60-75 in community settings led by trained~     community health workers.~   "
30550|NCT02657226|"~     This study aims to examine the association between intensive monitoring of renal function~     (urine output, serum creatinine, and both) and outcomes among critically ill patients with~     and without Acute Kidney Injury (AKI)~   "
30551|NCT02657213|"~     The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with~     MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison~     sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type~     1 diabetic adults with an increased risk of hypoglycemia.~      The study should show:~        -  A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a~          reduction in the time spent in hypoglycemia six months in any group compared to~          Baseline.~        -  A complete prevention of severe and not severe hypoglycemia in the pump group Minimed~          640G + Enlite sensor with SmartGuard activation~   "
30552|NCT02657200|"~     KAP-study in Flemish midwives with intramural employment~   "
30553|NCT02657187|"~     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis~     of the affected skeletal muscles. There have been several studies reported positive~     relationship between muscle mass and amount of neuromuscular junction. The purpose of this~     study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle~     mass.~   "
30554|NCT02657174|"~     The association between low level laser and auricular acupuncture can be an alternative when~     conventional drugs are contraindicated or to reduce the quantity of these postoperative~     medications. The objective of this study is to evaluate the efficiency of low level laser at~     auriculotherapy points in reducing postoperative pain in lower third molar surgery. Eighty~     third molars surgeries will be performed in 40 healthy patients by a split-mouth design.~     Immediately after surgery, each side of the patient's mouth will be randomly treated with~     different regimens in a double-blind design: low level laser in auricular acupuncture points~     or simulation of its use. This treatment will be performed at 24 and 48 hours after surgery.~     The primary variable is the post-operative pain. The secondary variables are trismus, edema~     and local temperature. They will be assessed at baseline, 24 hours, 48 hours and seven days~     after surgery.The blood samples for analysis of systemic inflammatory cytokines (TNF-α,~     interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours~     after surgery.~   "
30555|NCT02657161|"~     Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based~     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the~     PIKA adjuvant. The primary objective of the study was to assess the clinical safety of the~     vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the~     vaccine's efficacy based on an accelerated vaccine regimen.~   "
30556|NCT02657148|"~     The investigators have designed a single site, Phase IV open label, prospective~     observational clinical trial to compare the effect of immediate postpartum Nexplanon~     placement (IPP) versus standard postpartum contraceptive care (control) on consistent~     contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent~     (OD) women.~   "
30557|NCT02657135|"~     TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a~     research study that brings together TBI patients, advanced evaluation methods, and experts~     in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects~     self-help strategies might have on TBI outcomes.~   "
30558|NCT02657122|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single ascending doses and multiple ascending doses of the investigational drug TD-1473~     compared to placebo in healthy subjects.~   "
30601|NCT02656563|"~     This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and~     safety of monthly Radium 223 in prolonging the off treatment interval of men with localized~     prostate cancer receiving intermittent androgen ablation therapy for a rising PSA~     post-radiation or post-prostatectomy, who are at high risk for occult metastases.~   "
30559|NCT02657109|"~     4 consecutive days with volunteers between the first and fourth postoperative period of~     cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group~     submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the~     study, which consists of respiratory and metabolic exercises. The second group, called Early~     Mobilization Group in addition to the aforementioned exercises will be added exercise in~     cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization~     group volunteers will be placed in a sitting position in the bed with the backrest raised to~     45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days~     of active mode, the training load shall be such that the voluntary maintained throughout~     training a level of fatigue, maintaining level of heart rate predicted for age increased by~     70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of~     heart rate variability with the Polar monitor RS800CX brand model before surgery was~     performed first postoperative day and fifth postoperative day in the control groups and~     early mobilization.~   "
30560|NCT02657096|"~     In light of the controversy that are already approved but that however still exists~     regarding the efficacy and influence of the decontaminant tools for the management of~     Chronic Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the~     post-treatment clinical parameters and immunological and gingival microbial profiles in~     patients with CP, treated by either SRP in addition to desiccant or SRP alone.~      The null hypothesis to invalidate was that, after a one year follow-up, there were no~     variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between~     SRP + desiccant and SRP alone treatment.~   "
30561|NCT02657083|"~     The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the~     standard treatment without computer algorithm decisions - SAP therapy in 20 children and~     adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity.~      The aims of the study are:~        -  to demonstrate that the use of DreaMed MD-AID is safe during physical activity~        -  to investigate the risk of hypoglycemia among children and adolescents with T1D after~          afternoon exercise during closed-loop control.~   "
30562|NCT02657070|"~     The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT),~     a novel rehabilitation method that augments visuomotor feedback of movements of the patient~     in virtual reality, is effective in treating hemiparesis resp. learned non-use.~   "
30563|NCT02657057|"~     The purpose of this study is to determine if Transcutaneous Sacral Nerve Stimulation (TENS~     SNS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option~     for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.~   "
30564|NCT02657044|"~     Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal~     cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique~     for resection of large distal colorectal adenomas, however, maintains some important~     limitations. In large lesions, EMR can often only be performed in a piecemeal fashion~     resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic~     submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a~     longer procedural time, but is promising due to the high en-bloc resection rates and the~     very low recurrence rates. The aim of this multicenter randomized study is to compare EMR~     and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this~     into perspective against the costs and complication rates of both strategies and the burden~     perceived by patients on the long term-term.~   "
30565|NCT02657031|"~     This study compares the efficacy of low dose Ketamine versus Compazine for the control of~     headache in patients presenting to the Emergency Department.~   "
30566|NCT02657018|"~     The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based~     game application) is suitable to increase daily physical activity and physical activity~     adherence as well as health parameters such as cardiorespiratory fitness, leg strength,~     glucose metabolism, vascular health and self-determination as well as health related quality~     of life in the course of a 24-week intervention in comparison to the control group receiving~     one-time lifestyle counseling.~   "
30567|NCT02657005|"~     Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets~     family transcription factors driving tumor progression. TK216 is designed to inhibit this~     effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is~     a first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to~     establish initial safety and efficacy data to assess the potential of TK216 for further~     development.~   "
30568|NCT02656992|"~     Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose~     of this study is to evaluate the effects of high-intensity inspiratory muscle training~     (High-IMT) and sham High-IMT (control) on exercise capacity, respiratory muscle function~     (strength and endurance) and health related quality of life in patients with bronchiectasis.~   "
30569|NCT02656979|"~     The main purpose of this project is to investigate the blood flow of the ophthalmic artery~     (OA) in patients with ocular hypertension, high tension glaucoma and normal tension~     glaucoma. It is also to study the influence of the intraocular pressure difference on OA~     blood flow in the two first groups. Furthermore, the investigators want to understand the~     relationship between ocular dynamics, blood flow and structural alternations of the optic~     nerve head (ONH). The rationale behind the study is to improve knowledge of the pathogenesis~     of glaucoma.~   "
30570|NCT02656966|"~     In this prospective nonrandomized study the investigators are going to investigate whether~     auricular acupuncture with indwelling fixed needles is feasible for treatment of~     preoperative anxiety.~      Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to~     receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not~     wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI)~     questionnaire) and will form the control group. The preoperative anxiety using STAI, as well~     as the duration and quality of sleep on the night before surgery, the incidence of side~     effects, blood pressure and heart rate will be the outcome measures in this study.~   "
30696|NCT02655315|"~     This study evaluates the effect of iron chelation as a therapeutic strategy to slow the~     progression of Parkinson's disease. Half of participants will receive the deferiprone to 15~     mg / kg twice daily morning and evening (30mg / kg per day), while the other half will~     receive a placebo. The treatment lasts nine months.~   "
30571|NCT02656953|"~     The aim of this study is to investigate the impact of wearing visual display units (VDU)~     lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers~     with work related neck complaints. This will be evaluated by means of questionnaires (Neck~     Disability Index and Visual Fatigue Questionnaire), muscle tone, elasticity and stiffness,~     pressure pain threshold and 2D video analysis of head posture during a VDU task.~   "
30572|NCT02656940|"~     The purpose of this study is to determine whether the modulation of dietary lipids are~     effective in the treatment of obesity and comorbidities.~   "
30573|NCT02656927|"~     The purpose of this randomized controlled study is to evaluate psychological variables,~     mindfulness, and pain in the context of a specialized yoga program for individuals with SCI.~     Participants will be randomized to either a wait-list control condition or to a specialized~     yoga program condition.~   "
30574|NCT02656914|"~     The purpose of this study is to evaluate the non inferiority of the clinical efficacy of the~     drug associations in the treatment of flu symptoms~   "
30575|NCT02656901|"~     This study is designed to test the hypothesis that closed loop system reduces post operative~     cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane,~     total intravenous anesthesia manually guided by bispectral index in urologic surgical~     patients.~      The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs~     younger surgical patients.~   "
30576|NCT02656888|"~     The purpose of this study is to evaluate the non inferiority of the clinical efficacy of the~     drug associations in the treatment of flu symptoms.~   "
30577|NCT02656875|"~     Patients with moderate to severe pain caused by medical conditions or surgery, who require~     IV opioid therapy may be enrolled in this open label safety study. Patients will be treated~     with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as~     determined by the investigator, for a duration not to exceed 14 days.~   "
30578|NCT02656862|"~     Fever is one of the main reasons for outpatient consultations in sub-saharan Africa.~     Following the introduction of malaria RDTs, clinicians face a high number of~     malaria-negative patients for whom they do not have a clear diagnosis. Through clinical~     history and examination, acute fever patients are categorized into: acute respiratory~     infections, urinary tract infections and other focal infections, diarrheal fevers and~     undifferentiated fevers. The latter being patients where no focal source of infections can~     be found during the consultation visit. In this proposal, the investigators focus on these~     acute undifferentiated fevers in an outpatient clinic.~      These fevers have the challenge of few point-of-care tests (POCT) available for the~     clinicians to identify the etiology of fever and guide treatment in resource-limited~     countries. As a consequence, over-prescription of antibiotics has increased. In order to~     improve patient outcomes while supporting judicious use of antimicrobials, there is an~     urgent need to change the management of febrile patients in low-income countries. This can~     only be achieved by providing evidence-based clinical guidelines for the management of these~     acute febrile patients. To develop such guidelines, epidemiological data on etiologies of~     undifferentiated fever need to be generated. The investigators will evaluate pathogen~     infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute~     undifferentiated fever. To evaluate the existence of aspecific and subclinical infections~     and co-infections, the investigators will also test a subsample of 200 patients with ARI,~     UTI, diarrheal fever and malaria. The investigators expect to have as main results:~     proportions of each syndrome among fever patients, key pathogens associated with~     undifferentiated fever and their clinical presentation and demographic characteristics.~   "
30579|NCT02656849|"~     This research study is studying whether a new experimental cancer study drug BAY 1000394~     will be helpful in treating solid tumor cancer with an abnormality in one of the following~     genes: Mcl-1, Myc or CCNE.~   "
30580|NCT02656836|"~     The overall objective of the study is to scope the self-management for self-monitoring~     glaucoma using home tonometry.~   "
30581|NCT02656823|"~     Multicenter study to assess the survival and the success rates of six short implants~     (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5~     years in function.~   "
30582|NCT02656810|"~     The purpose of this study is to compare the pharmacokinetics (blood levels) of two~     teriparatide products, PF708 and Forteo, in healthy subjects.~   "
30583|NCT02656797|"~     Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment~     for cutaneous leishmaniasis of Leishmania species major and tropica.~   "
30584|NCT02656784|"~     This is a sample made up of ninety-six adult individuals of both sexes to be divided into~     three groups: the experimental group of thirty-two patients with OCD who will be undergone~     Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject~     Exposure and Response Prevention and the control group of thirty-two healthy individuals.~     Interviews and therapeutic intervention occur in private practices researchers or medical~     schools accredited by UESPI.~      Experimental group: Will be eligible adults of both sexes with educational level equal to or~     higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed~     according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had~     previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.~   "
30585|NCT02656771|"~     The purpose of this study is to measure quantitatively the implant stability and implant~     related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric®~     Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical~     uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by~     model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive~     bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).~   "
30586|NCT02656758|"~     The investigators intent to recruit 80 attention deficit hyperactivity disorder families.~     The attention deficit hyperactivity disorder families had received executive function~     training one year before.They will be randomized to intervention group and control group~     using a block randomization design. The intervention group will participate in intensive~     executive function training immediately,while the control group will receive executive~     training after 3 months.~   "
30587|NCT02656745|"~     The Sponsor is doing a research study to assess the effects of a smartphone program designed~     to help users smoke less and eventually quit. When participants join, their involvement in~     the core study will last 8 weeks. After 8 weeks, they will have the option to continue using~     the program to guide their quit journey or participate in follow-up research.~   "
30588|NCT02656732|"~     The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20~     to 54 years) suffering from Miller's class I or II gingival recession. Patients were~     randomly assigned into two equal groups; control group; the coronally advanced flap with the~     subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap~     with amnion chorion allograft membrane (CAF+AC).~   "
30590|NCT02656706|"~     Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma.~     High dose interferon is a standard of care in the adjuvant setting but is highly toxic and~     marginally effective. The combination of ipilimumab and nivolumab is the most active regimen~     in patients with advanced melanoma so there is clear rationale to test this regimen in the~     adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg~     ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be~     six months.~   "
30591|NCT02656693|"~     The goal of this project is to adapt an evidence-based online weight management program and~     integrate it with population management support from primary care practices. Investigators~     then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1)~     the combined intervention (online weight management program plus population management~     support) with 2) the stand-alone online weight management program and with 3) usual care,~     among overweight and obese primary care patients with type 2 diabetes or hypertension. The~     specific aims are:~        1. a. To adapt an online weight management program and integrate it with population~          management support, incorporating input from patients, primary care clinicians, and~          other stakeholders; afterward, investigators will acquire feedback on the positive and~          negative aspects of the intervention.~           b. To compare the effectiveness of the combined intervention (online weight management~          program plus population management support) with the stand-alone online program and~          with usual care.~           Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months~          compared with the stand-alone online program and with usual care.~        2. To identify mediators of the combined intervention and the stand-alone online program.~           Hypothesis 2: The effects of the combined intervention and the stand-alone online~          program on weight loss will be mediated by patients' level of engagement, changes in~          self-efficacy, and changes in diet and physical activity.~        3. To explore whether the effectiveness of the combined intervention and the stand-alone~          weight management program varies by patient characteristics.~      Hypothesis 3: The interventions will be more effective among patients who are younger,~     white, and higher socioeconomic status, although the population management strategy may help~     to reduce these differences.~   "
30592|NCT02656680|"~     In a pilot randomized trial of 160 obese participants, investigators will test the~     feasibility of a behavioral weight loss program delivered entirely via Facebook.~     Participants will be randomized to a condition in which they will be able to invite their~     friends, or a condition with study participants only. All participants will receive~     behavioral counseling via the private Facebook group from the coaches who are present on the~     network daily. Participants will track their diet and exercise via a free commercial mobile~     app.~   "
30593|NCT02656667|"~     The aim of this study is to evaluate the effectiveness of quadriceps strengthening with~     neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary~     rehabilitation program , in patients with severe or very severe COPD , according to GOLD~     with BODE index ≥ 5 .~   "
30594|NCT02656654|"~     Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is~     essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and~     prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably~     in patients with acute renal failure. Improving fluid balance is considered crucial in the~     management of patients in septic shock, but the efficacy of the measures currently proposed~     (diuretics associated or not with albumin and/or dialysis) is controversial. The~     investigators hypothesize that a whole-body compression using a body bandage could reduce~     capillary leakage and thus lead to faster restoration of a normal transmural pressure~     gradient in postcapillary venules and improve venous return.~      This is the first study to evaluate mechanical compression using a body bandage to reduce~     oedema in septic shock.~      To do this, a whole-body compression will be set up within the 12 hours following admission.~     Water balance will be monitored daily throughout the duration of the compression and vital~     status of patients will be search at 7 days, 28 days and 90 days.~   "
30595|NCT02656641|"~     This study will assess the effects of client feedback, using the Patient Health~     Questionnaire - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety~     in individuals undergoing brief psychotherapy. Client feedback allows therapists to monitor~     treatment progress in real time. Identifying an easily accessible treatment intervention,~     which utilizes commonly used scales, that potentially enhances the effect of brief~     psychotherapy and improves treatment outcomes is a valuable endeavor with clear implications~     for therapy practices. It is hypothesized that clients who complete these scales each~     session will show greater symptom improvement than clients who do not complete the scales.~   "
30596|NCT02656628|"~     The purpose of this multi-center patient registry is to obtain first clinical results and to~     assess short and mid-term clinical outcome data of patients treated with DLS.~   "
30597|NCT02656615|"~     To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and~     prior response to abiraterone.~   "
30598|NCT02656602|"~     Better patient education prior to colonoscopy improves adherence to instructions for bowel~     preparation and leads to cleaner colons. The hypothesis of this trial is that computer~     assisted instruction (CAI) using video and 3D animations can maximize the effectiveness of~     nurse counselling and consequently improves bowel cleanliness. Furthermore, CAI will~     positively influence the patient experience.~      Adults referred for colonoscopy were included in a Dutch large volume endoscopy unit.~     Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were~     prospectively divided into two groups, one receiving nurse counselling and one receiving CAI~     and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during~     examination, was measured with the Ottawa Bowel Preparation Scale (OBPS) and the Boston~     Bowel Preparation Scale (BBPS). Patient comfort and anxiety were assessed at multiple time~     points: directly after the instruction and one hour before colonoscopy. Comfort was rescored~     2 hours after colonoscopy. We also tested knowledge and comprehension one hour before~     colonoscopy. Statistical analyses included Mann-Whitney.~   "
30599|NCT02656589|"~     This projective observational study is planned to enroll more than 300 advanced breast~     cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization~     (FISH) and / or immunohistochemistry, and 100 healthy donors as control. Before treatment,~     the plasma microRNA will be collected and detected by microRNA extraction kit and~     quantitative polymerase chain reaction (qPCR), respectively. After analyzed their microRNA~     expression by microRNA predictive model, previously reported by our team, all of enrolled~     patients will be classified as probable sensitive group or probable resistant group.~     Herceptin combined with other chemotherapy will be the backbone of salvage treatment and~     used for at least 3 months; the change of local masses and metastasis lesions after~     treatment will be documented to evaluate the response. Based on these results, investigator~     aim to construct a mathematical predictive model by analyzing the correlation of baseline~     microRNA expression level and the prognosis of patients. And a diagnosis microRNA kit will~     be planned and manufactured~   "
30600|NCT02656576|"~     Multicentre prospective study of concordance between two tissue sampling modes (smear /~     biopsy), which applies the same diagnostic method (PCR).~   "
30602|NCT02656550|"~     This study aims to investigate the treatment of absolute uterine infertility (AUI) due to~     congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The~     investigators will follow a model based on a Swedish study to enroll 10 women with~     functioning ovaries and successfully transplant the uterus from either a living or cadaveric~     donor, with the goal of live birth after transplantation.~   "
30603|NCT02656537|"~     In this clinical investigation, the safety, feasibility and performance of the novel EnSite™~     HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be~     studied in patients undergoing catheter ablation procedures for the treatment of~     non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).~   "
30604|NCT02656524|"~     The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study~     should provide information about clinical characteristics of Hungarian regorafenib patients~     as well as information about safety and efficacy of regorafenib in Hungarian patients with~     metastatic colorectal cancer. This much needed data is required by the National Health~     Insurance Fund in order to accept regorafenib into the regular reimbursement system. This~     study is proposed to be based on patient data from the Hungarian National Health Insurance~     Fund's Database. Data to be analyzed includes patient demography and baseline tumor~     characteristics, overall survival, time to treatment failure, duration of treatment, average~     dose and dose modifications, and adverse events. Further, treatment costs will be estimated.~   "
30605|NCT02656511|"~     The purpose of this study is to identify and provide immediate antiretroviral therapy to a~     cohort of HIV-infected individuals with hyperacute infection (estimated date of HIV~     infection within the last 30 days). The primary aim of the study is to evaluate whether~     initiation of dolutegravir plus emtricitabine/tenofovir during hyperacute HIV infection~     leads to protection of CD4+ T cells in the peripheral blood and gut-associated lymphoid~     tissue from infection.~   "
30606|NCT02656498|"~     This is a cross-sectional and longitudinal study to evaluate the clinical utility of~     [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild~     cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.~   "
30607|NCT02656485|"~     This is a single center, randomized, double-blind, placebo-controlled study in subjects with~     acne vulgaris. After a screening visit and a one-week washout (if applicable), three~     sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days~     in three groups of subjects. Each group of subjects will be randomized to receive the~     planned doses of B244 or placebo BID~   "
30608|NCT02656472|"~     The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolyntic~     drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing~     pediatric cardiac surgery.~   "
30609|NCT02656459|"~     The purpose of this study is to examine the immune response to traumatic injury and~     subsequent infections in critically ill adults. Traumatic injuries lead to severe~     dysregulation of the immune system, and predispose to severe infections. Diagnosing these~     infections in a timely manner is paramount in reducing morbidity and mortality, but~     diagnosis is made difficult by the inflammatory response to trauma. The main purpose of the~     study is to prospectively test the diagnostic power of the expression of an 11-gene set~     which the investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the~     timing of an acquired infection cannot be determined a priori, this study is designed to be~     a longitudinal examination of a cohort of traumatically injured adults. The investigators~     will draw blood at regular intervals, as well as at day of diagnosis of infection for any~     patient that are diagnosed with an infection. The investigators will then assay the blood~     for gene expression levels post hoc, and correlate the molecular profiles with clinical~     information to establish a prospective estimate of diagnostic power.~   "
30610|NCT02656446|"~     The purpose of this study is to determine if a handheld ultrasound device helps in the~     placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound~     device compared to a standard ultrasound machine.~   "
30611|NCT02656433|"~     30 children between 4 and 7 years old with moderate to severe motor impairment, 50% males~     50% females will participate in an interventional study in two groups: placebo and~     experimental group.~      Placebo group will only receive traditional treatment with physiotherapy and the~     Experimental or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive~     Stimulation.~   "
30612|NCT02656420|"~     This study will examine the extent to which lower doses of a broccoli-derived beverage~     enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose~     shown to be effective previously.~   "
30613|NCT02656407|"~     A wide spectrum of methods is used to image brain activation in vivo. It can be directly~     detected by neurons electrical activity imaging (cortical simulation mapping, calcium~     imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the~     neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical~     imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic~     resonance imaging (fMRI)).~      Ultrasound as the potential to complement these functional imaging techniques at low cost.~     Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging~     of major vessels has been limited until now due to its poor sensitivity. To overcome this~     limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This~     technique enables high spatio-temporal resolution imaging of whole-brain microvasculature~     dynamics in response to brain activation without the need of contrast agent.~      This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect~     blood flow in most of cerebral vessels (arterioles, big venules and larger vessels).~     Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow~     flow dynamics in such vessels modulated by local neuronal activity.~      Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal~     resolution and high signal to noise ratio. The aim of this study is now to apply fUS on~     human brain in intraoperative condition.~      The main objective of this study is to find activation maps through intraoperative~     ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional~     MRI.~      Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method~     will be used for different types of stimuli and intensity and the investigators will do some~     control acquisitions. Blood vessel density observed with a conventional Doppler will be~     compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler~     mode enhance micro vessel visualization.~   "
30614|NCT02656394|"~     To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for~     28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with~     glaucoma medications.~   "
30658|NCT02655809|"~     The aim of this study is to assess the in vivo kinematics and range of motion of a~     single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining~     total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of~     the normal healthy knee.~      Patients would be evaluated by fluoroscopic examination during weight bearing activities~     (lounging, kneeling and stairs climbing).~   "
30615|NCT02656381|"~     Background:~      Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes~     serious side effects or does not work. Researchers want to learn more about uveitis and why~     some people develop it.~      Objective:~      To learn clinical and genetic factors that may make people develop uveitis and influence how~     they respond to treatment.~      Eligibility:~      People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease~     related to eye inflammation~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Eye exam~      Participation lasts up to 10 years. The clinic visit schedule varies depending on~     participants eye disease:~      Baseline visit with annual follow-ups~      Baseline visit, visits at months 3 and 6, and annual follow-ups~      Another schedule set by the researcher~      Depending on participants eye disease, tests during each visit could include:~      Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle~     in the arm~      and flows through the blood vessels in the eye. A camera takes pictures of the eye.~      Electroretinography: Participants sit in the dark with their eyes patched.~      After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is~     stimulated with flashing lights.~      Perimetry: Participants look into a bowl or lens and press a button when they see a light.~      Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed.~      Anterior chamber tap: A needle enters the eye to remove fluid.~      Blood and urine tests~      Saliva, stool, hair, or tear samples~      Cotton swab of the inside of the cheek.~      During the study, participants may need immunosuppressive treatment, such as drugs or~     injections in or around the eyes depending on their disease.~   "
30616|NCT02656368|"~     SEBORRHEAMEDIS Face Cream is a barrier-based, non-steroidal cream. The cream includes plant~     extracts The cream was designed to manage the symptoms of facial Seborrheic dermatitis~     symptoms such as erythema, scaling and pruritus.~   "
30617|NCT02656355|"~     Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies~     showed that the GI difficulty was related to impaired anticipatory postural adjustments~     (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were~     observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal~     multiple APAs were observed during GI.~      Conventional balance tests record the maximum displacement and/or velocity of Center of~     pressure (COP). However, these variables could not show the performance of APA. Previous~     studies suggested that balance and gait initiation were controlled by separate neural~     circuitries. This could explain why the conventional COP measurement did not correlate to GI~     very well.~      It is important to develop GI related APA tests and trainings. Researchers found that a~     perturbation applied before the COP displacement during GI could delay both GI and APA. This~     indicates that COP displacement has APA components. Our pilot study shows that there is a~     reverse direction of COP displacement before voluntary COP displacement, suggesting the~     existence of APA.~      This three year project will evaluate the relationship of the APA of voluntary COP~     displacement and the APA of GI, establish the APA test for PD, and investigate the effect of~     APA training on GI in people with PD.~      In the first year, 20 people without disability will be recruited. The APA before voluntary~     COP displacement test, APA before GI, and gait performance will be evaluated. In the second~     year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI~     test, gait test, and APA before voluntary COP displacement test. The relationship between~     different types of APA will be established for PD and healthy people. In the third year, 30~     people with PD will be randomized into APA training group, balance group, and control group.~     The different training effect will be evaluated especially on GI, gait performance, and~     freezing of gait.~      This project will advance the knowledge of mechanism of GI difficulty. The result of this~     project can be applied to clinical rehabilitation of people with GI difficulty.~   "
30618|NCT02656342|"~     In this randomized controlled trial (RCT) the investigators experimentally test if patients~     with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and~     response prevention (ERP), but either relapsed or not responded, profit from the combination~     of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate)~     d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.~      The project expects to demonstrate a significant improvement in all groups, and anticipate~     that a higher proportion of the patients who receive DCS will show a better long-term gain~     from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5~     years after treatment). In addition, the project will highlight changes in depression,~     sleep, global functioning, quality of life, work and social status. Changes in medication~     and use of health care will be included and related to the main objective of the study.~   "
30619|NCT02656329|"~     This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate~     the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable~     cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class~     II and III heart failure patients with 30%≤left ventricular ejection fraction (LVEF)≤35%%,~     and in particular, for identifying patients who are at low risk for sudden cardiac death and~     who would not benefit, or may suffer harm, from implantation of an ICD device.~   "
30620|NCT02656316|"~     The current RCT aims to establish the therapeutic potential of tDCS for freezing of gait~     (FOG) and motor-cognitive dysfunctions in PD. As noted, FOG is often unresponsive to~     pharmacological and other treatments, especially in the advanced stages of the disease.~     While it is likely that tDCS will provide symptomatic relief, we will also explore, via~     secondary outcomes, the potential for tDCS to modify disease progression. Support for this~     possibility stems from the likely mechanisms of action of tDCS.~   "
30621|NCT02656303|"~     This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab~     (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms~     previously enrolled in Protocol UTX-TGR-304~   "
30622|NCT02656290|"~     The objective of this trial is to assess the safety and effectiveness of the Edwards~     Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five~     years or older requiring replacement of their native or prosthetic pulmonary valve.~   "
30623|NCT02656277|"~     This study is a randomized controlled trial using Duke patients to test, compared to the~     standard of care, a questionnaire and statistical model used to determine how patient~     preference regarding shoulder pain, physical limitations, physical therapy, recovery period,~     prognosis, and cost impact choice of surgical versus non-surgical intervention.~      Phase 1 of this study is the initial testing of the instrument and involves a small group of~     up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder~     Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized~     to receive either the Decision Tool or the standard Information on Shoulder Dislocation~   "
30624|NCT02656264|"~     The purpose of this study is to determine the effects of whether urgent or elective cesarean~     section on the occurrance of chronic pain.~   "
30625|NCT02656251|"~     The aim of the study is to compare the effect of a suspension containing chlorhexidine and~     alcohol and another one containing clorhexidine with no alcohol in dynamic of the~     subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm~     formation will be evaluated by means of Plaque Free Zone (PFZ).~   "
30683|NCT02655484|"~     The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects~     or patients with COPD ventilated during exercise assisted by the single-limb circuit with a~     plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level~     of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for~     predicting CO2 rebreathing.~   "
30626|NCT02656238|"~     The New International CTEPH Database is a prospective, observational multi-center disease~     registry run by the International CTEPH Association (ICA), which will collect data in~     chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will~     run for approximately 5 years. Its objective is to provide an overview on epidemiology of~     CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of~     long-term outcomes as measured by New York Heart Association (NYHA) functional class and~     survival.~      The data collected will improve the knowledge and understanding of this condition, support~     the further development of diagnosis and treatment guidelines for patients with CTEPH, and~     contribute to improving patient care in the long-term.~   "
30627|NCT02656225|"~     The prevalence of postpartum anemia is a great threat for maternal and infant health without~     timely and effective treatment. Oral iron therapy has been used for centuries as a treatment~     of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and~     even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide~     glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has~     been widely used in the treatment of various types of anemia in China for decades and might~     be a potentially effective therapy for postpartum anemia. Recently, studies involving animal~     subjects have helped shed light on its mechanism of action.~      In this study, the investigators aimed to conduct a randomized controlled trial to assess~     the efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild~     postpartum anemia with or without iron deficiency.~   "
30628|NCT02656212|"~     This will be a double-blind, randomized, placebo-controlled, single dose study of (+)-~     epicatechin with one 30mg dose/day for a total of 7 days~   "
30629|NCT02656199|"~     We will investigate whether measurement of the change in thickness of the diaphragm during~     the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We~     will also asses whether this is only possible on low levels of pressure support as has been~     shown previously, or if this technique retains its predictive power at higher levels of~     pressure support.~   "
30630|NCT02656186|"~     The purpose of this study was to determine the improvement in nutritional status, especially~     in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in~     the circulating cytokine levels, after providing extra protein and energy contents to~     community-dwelling older adults at risk of undernutrition.~   "
30631|NCT02656173|"~     The primary objective of the study is to investigate the efficacy of mirabegron versus~     placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for~     BPH.~   "
30632|NCT02656160|"~     In this protocol the investigators will test the effect of dalfampridine (a potassium~     channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in~     healthy control subjects.~   "
30633|NCT02656147|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed~     CD19+ haematological malignancies.~   "
30634|NCT02656134|"~     Background and study aim The relative risks of duodenal adenocarcinoma and ampullary~     carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times~     higher than in general population. However risk factors, including a genotype-phenotype~     association for duodenal cancer in FAP has not been fully understood. The aim of this study~     is to determine risk factors associated with the development of advanced duodenal polyposis~     and ampullary adenomas in colectomized patients with FAP.~   "
30635|NCT02656121|"~     Recently, a special emphasis has recently been directed to the potential role of vitamin D~     and some regulatory peptides (e.g. adipokines and follistatin) and their associated~     metabolic roles and genetic factors in the development of PCOS and its related~     co-morbidities. The aim of this study is to compare the effect of vitamin D supplementation~     therapy and Metformin therapy on plasma concentrations of adipokines (ghrelin, resistin and~     adiponectin), follistatin and activins in participants diagnosed with PCOS.~   "
30636|NCT02656108|"~     This is a comparative study which will be conducted in Ain Shams University Maternity~     hospital to assess the individual and specfic role of controlled cord traction as a part of~     active management of third stage of labor~   "
30637|NCT02656095|"~     This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans.~     LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein~     lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no~     longer functional. This can cause conditions known as high triglycerides in the blood and~     inflammation of the pancreas.~      Investigational medications to treat LPLD are currently being developed. In order to see if~     these medications are effective, it is necessary to be able to accurately measure LPL~     activity in humans.~      LPL activity has been successfully measured in animal models after giving heparin. Heparin~     is a blood thinner which is approved by the FDA. It is originally used to prevent blood~     clots. This study will administer heparin to healthy adults through intravenous infusion~     (IV). Blood samples will be collected before and after the infusion to test LDL levels.~      The purpose of this study is to develop a cheap, more reliable standard for assessment of~     LPLD in patients~   "
30638|NCT02656082|"~     The purpose of this study is to determine whether Etanercept which is given through~     intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE).~      The investigators also would like to develop new tests to measure skin inflammation by~     scanning the affected skin using optical coherence tomography (OCT), thermography and laser~     doppler imaging (LDI) and taking photographs of the rash (to be done before and after~     treatment). If the findings from these new tests are similar to the ones from taking a~     sample of skin (biopsy), then the latter (which is an invasive test) can be avoided.~   "
30639|NCT02656069|"~     This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen™~     (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for~     hypoglycemia rescue of adult patients with type 1 diabetes.~   "
30640|NCT02656056|"~     The consumption of fermented soy foods can alter the human microbiome and may confer health~     benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus (QC)~     fermented soy beverage in humans, assessing immunological, microbiological, and clinical~     parameters.~   "
30641|NCT02656043|"~     Phase 1/2 study enrolling 48 healthy volunteers in Phase 1 followed by 150 subjects with~     acne vulgaris in Phase 2.~   "
30642|NCT02656030|"~     Recent studies indicate that the patients with chronic neck pain present decreased~     activation and weak of neck muscles, especially deep flexor and extensor muscles.~     Alterations of deep are associated with pain and impairment of neck function in chronic neck~     pain.~      Exercise is known to be an important component of treatment programs for patients with neck~     pain. Recently, many studies have focused on specific training on deep cervical muscles,~     especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using~     cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck~     disability, changing in activation of deep cervical flexor muscles. Further, the cervical~     extensor muscles are believed to be equally important for the rehabilitation of patients~     with neck pain. However, the retention effect of semispinalis cervicis exercise is unknown.~     Therefore, the semispinalis cervicis exercise still need more evidence to support clinically~     effects.~      The current study will be conducted to fill the gap of the previous study in immediately,~     short, and long term effects of semispinalis cervicis exercise in chronic neck pain.~   "
30643|NCT02656017|"~     This study will test to see if metformin is safe and if it is tolerated compared to placebo~     in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages~     of chronic kidney disease. We will also measure its effect on progression of kidney disease~     as reflected in the kidney size and the kidney function, along with its effect on kidney~     pain and quality of life.~   "
30644|NCT02656004|"~     The essential eucalyptus oil has therapeutic potential in the cardiovascular system, with~     possibilities of acting on the autonomic tonus and reduction of cardiovascular overload.~     Hemodynamic conditions can change during the physical requirement and offer a framework of~     increased cardiovascular risk, especially for elderly individuals. In this sense,~     preservation strategies of cardiovascular autonomic control and demand in this population in~     conditions of rest and/or exercise are required. The aim of this study was investigate the~     effect of the essential eucalyptus oil on cardiovascular responses and recovery during~     submaximal isometric resisted exercise series in the elderly. Twenty elderly male (69.1 ±~     5.7 years; 75.3 ± 12.3 kg; 168.0 ± 6.0 cm) participated in this study. Were excluded from~     the sample the volunteers who presented some serious illness known according to the criteria~     of risk stratification of the American College of Sports Medicine. In random order crusade,~     the volunteers were subjected to: 1) trial session through the essential eucalyptus oil and~     inhalation; 2) session control without inhalation of essential eucalyptus oil. After the~     sessions 1 and 2, the volunteers remained in recovery for a period of 60 minutes, in~     temperature-controlled environment and comfortably seated. After this period were performed~     3 sets of isometric resisted exercise on dominant upper limb in intensity of 30% of maximum~     voluntary contraction in 1 min each, with 1 min recovery interval. Measures of heart rate,~     blood pressure, rate product pressure and heart rate variability were held in the rest for~     20 min, in recovery during 60 min and during the 3 sets of isometric resisted exercise.~     Indicators of heart rate variability were analysed from the time and the frequency domain.~     ANOVA two-way for repeated measurements with Post Hoc of Tukey were employed (p<0.05).~   "
30645|NCT02655991|"~     This study will determine whether telephone support improves clinical outcomes of veterans~     who begin outpatient treatment for posttraumatic stress disorder. Participants will be~     randomly assigned to receive either usual care or usual care supplemented by biweekly~     monitoring and support by telephone during the first 3 months of treatment. Patients in both~     conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking~     at 4 months and 12 months after entering treatment.~   "
30646|NCT02655978|"~     The overall goal of this study is to employ diffusion-weighted imaging (DWI) and~     tractography to investigate differences in connectivity in the rostral dorsal cingulum~     bundle (CB) in patients with bipolar disorder type I (BDI) compared to matched controls, and~     to utilize this information to determine if high-frequency deep brain stimulation (DBS) of~     the rostral dorsal CB has realistic potential as a therapy for producing mood stabilization~     in patients with BDI.~   "
30647|NCT02655965|"~     The aims of this study is to compare the effectiveness of pecs block associated to a general~     anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and~     the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy~     associated with axillary dissection This is a double-blind, placebo controlled study that~     will randomise breast cancer subjects in 1:1 ratio to receive a pecs block of Ropivacaine~     3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).~   "
30648|NCT02655952|"~     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role~     in the formation and dissemination of tumours. The present project focuses on the critical~     role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer~     disease.~      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which~     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby~     acting anti-metastatic.~      The aim of the first clinical phase I study was to establish the recommended dose for a~     clinical phase II study and enable further development of Foxy-5 as a first in class~     anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach~     maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be~     established based on toxicity. The aim of this study is to continue to establish the safety~     profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based~     on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to~     determine the biological response dose (BRD).~   "
30649|NCT02655939|"~     Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend~     contains individual ingredients which have been widely studied for its effectiveness in~     osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair~     the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus~     reducing the pain and inflammation of the joint.~      The two open-label studies have showed the effectiveness of the investigational product on~     OA. The 2 studies did not show any specific safety concern to be considered. The study~     demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results~     in the formulation.~      The supplement has been manufactured in GMP certified manufacturing units in Germany and~     India under strict quality control check. Hence, quality of the supplement and batch to~     batch consistency is well assured.~   "
30659|NCT02655796|"~     This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the~     elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of~     the Centers for Disease Control and Prevention (CDC).~      The OAK device is a technologic system, based on virtual reality. It allows to quickly~     perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The~     Balance Evaluation System Test), and kinematic and posturgraphic indexes. The participants~     interact with the OAK device through simple exercises, then the device provides an~     assessment of their functional mobility, equilibrium and postural reactions.~   "
30650|NCT02655926|"~     The overarching aim is to compare the effects of ventral capsule/ventral striatum (VC/VS)~     and subthalamic nucleus (STN) deep brain stimulation (DBS) in the same participants.~     Investigators will test the hypothesis, grounded in cognitive neuroscience, that DBS at both~     sites is better than either site alone for treating the symptom dimensions of obsessive~     compulsive disorder (OCD). Specifically, Investigators will employ novel cognitive paradigms~     and neurophysiological measures of cortical synaptic function to test the hypothesis that~     VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms~     is mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting~     obsessions and compulsions with STN DBS. Investigators will additionally determine whether~     adjunctive cognitive behavioural therapy (CBT) enhances the response to DBS by providing the~     cognitive and behavioural skills to optimise symptom management and daily function.~   "
30651|NCT02655913|"~     This trial studies efficacy and safety of combination of vitamin C infusion with modulated~     electro-hyperthermia (mEHT) in treatment of non small cell lung cancer patients.Phase I of~     this clinical study is to find the tolerable dose and best schedule of the combination of~     vitamin C infusion and mEHT that can be given to patients with NSCLC. Phase II of this study~     is to learn if the combination of vitamin C infusion and mEHT can help to control NSCLC and~     improve quality of life.~   "
30652|NCT02655900|"~     Injury to the muscles of the back passage (anal canal) is a relatively common problem. This~     injury can result in problems with bowel control later in life and usually occurs during~     vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently~     women who have sustained injury to the muscles of the back passage undergo an ultrasound~     scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the~     muscle of the back passage has healed i.e is intact or has a defect. The investigators would~     like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify~     the defects and hence avoid inserting the probe into the back passage. In addition to~     getting the above information using 3D ultrasound scan, the investigators would also like to~     identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be~     diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who~     sustain injury to this muscle are known to develop prolapse later on in life.~   "
30653|NCT02655874|"~     TROPICS1 is a randomized, observer-blind, active comparator-controlled, single-center, Phase~     IV trial in 200 participants aged ≥65 years. The control group will receive a standard dose~     licensed trivalent inactivated influenza vaccine at day 1, and an active-comparator~     (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group~     will receive the same influenza vaccine at day 1 and day 180. Endpoints are immunological,~     and include measures of haemagglutination-inhibition (HI) titres, micro-neutralisation~     titres and cell-mediated immunity at 4 time points after the initial vaccination up to Day~     360. The primary hypothesis is that participants receiving an influenza booster at day 180~     will achieve superior influenza seroprotection (HI titre ≥1:40) at day 208, compared to~     controls.~      The World Health Organization (WHO) estimates the global annual burden from seasonal~     influenza as 1 billion infections, with 3-5 million severe cases and 300,000-500,000 deaths.~     The pattern and impact of these infections varies considerably with climate. In temperate~     countries, influenza epidemics characteristically occur during the cold winter months, while~     in sub-tropical countries, they coincide with the rainy seasons. Closer to the equator,~     influenza virus activity is more complex. In Singapore, biannual epidemics are usual, but~     with continuous transmission year-round. Bi-annual epidemics, tri-annual epidemics and year~     round virus activity have also been described in other tropical countries, from Indonesia~     and Malaysia to Peru and Mexico.~      There is no published data reporting year-round influenza vaccine effectiveness in the~     elderly from countries with continuous influenza virus activity. Despite numerous studies~     worldwide exploring the HI antibody response to influenza vaccination, the majority of these~     do not continue follow up beyond seroconversion (21-28 days). However, of the few available,~     HI antibody titres declined following influenza vaccination in the elderly, such that within~     6-12 months geometric mean titres approached pre-vaccination levels. With biannual epidemics~     and year-round transmission in tropical regions, year-round seroprotection may be important~     to reduce influenza infections in this environment. A six-monthly vaccination cycle would~     correspond with the decline in vaccine-induced seroprotection in the elderly, and the~     6-monthly periodicity of outbreaks in Singapore and other tropical countries.~   "
30654|NCT02655861|"~     This project will follow babies with ichthyosis over time in order to better understand the~     natural course of ichthyosis in infants and children and to examine how specific genetic~     mutations affect clinical characteristics.~   "
30655|NCT02655848|"~     During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions~     are frequently encountered. However, the most optimal treatment of the diseased long head of~     the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or~     tenodesis. The hypothesis is that there is no difference in functional outcome between LHB~     tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.~   "
30656|NCT02655835|"~     Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase~     meditation practice as compared to another meditation program. The study will last six weeks~     for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will~     receive learning materials and guided meditations, but the implementation will be~     self-paced. Participants in the IMMI group will receive weekly learning sessions and be~     required to practice meditation every day. IMMI group participants will also receive a~     weekly reminder call from a member of the study staff and have access to technical support~     in the event of trouble with the online program. All subjects will complete online~     self-report questionnaires that measure quality of life, self-efficacy, mood, sleep,~     mindfulness, and perceived stress at baseline and at the end of the six-week intervention.~     Subjects will also be given a questionnaire at the end of the study gauging their~     satisfaction with the mindfulness program they participated in.~      Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to~     participants and demographic information about IMMI users. The study will be the same as~     noted above, but all subjects will be entered in the IMMI program.~      Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and~     Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e.~     increasing time or frequency of meditation sessions), and improve quality of life will be~     examined as well.~   "
30657|NCT02655822|"~     This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small~     molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune~     system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444~     as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various~     solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine~     suppresses the anti-tumor activity of T cells and other immune cells.~   "
30660|NCT02655783|"~     The objective of this study is to compare the effects of use of normal saline (250 cc / h),~     with or without dextrose supplement, on the evolution of labor in nulliparous.~   "
30663|NCT02655744|"~     Background. Primary central nervous system lymphoma (PCNSL) is an uncommon disease.~     Conventional treatment has consisted of either whole brain radiotherapy (WBRT) or~     methotrexate (MTX)-based combined modality therapy combining chemotherapy and cranial~     irradiation. The treatment principles at our institute have been quite consistent in the~     past, sticking to the treatment protocol reported by Memorial Sloan-Kettering Cancer Center~     in 1990s. No matter what the dosage of MTX is, it is well-established that the addition of~     chemotherapy to cranial RT significantly improved survival outcomes. However, it was found~     that delayed treatment-related cognitive sequelae emerged as a significant debilitating~     complication of combined modality treatment in patients with PCNSL, especially when~     effective treatment can achieve disease control and better survival rates. Furthermore, the~     specific contribution of the disease per se and various treatment modalities to cognitive~     impairment remains to be clarified because the neurotoxic potential of combined modality~     treatments is difficult to differentiate when each can result in cognitive dysfunctions~     respectively.~      Treatment-related neurotoxicity could be demonstrated by virtue of several meaningful~     indicators, including neurobehavioral assessments, neuroimaging outcomes, and even measures~     of quality-of-life (QoL).~      Methods. Therefore, this one-year individual research will be a prospective observational~     cohort study with a longitudinal assessment of neurobehavioral functions, neuroimaging, and~     quality of life for newly-diagnosed patients with primary CNS lymphoma at our institute.~     According to our cancer center, it is estimated that there would be around 25 cases of~     newly-diagnosed primary CNS lymphoma at our institute every year. By virtue of~     multidisciplinary management and teamwork consisting of neurosurgery, hematology, radiation~     oncology, neuroimaging expertise, and surgical pathology, investigators will attempt to~     recruit all potentially eligible patients with newly-diagnosed primary CNS lymphoma. Most~     importantly, the neuropsychologists will participate in our research project, in an effort~     to integrate the neurobehavioral outcomes into this prospective study. Accordingly, a~     battery of neuropsychological measures is used to evaluate neurobehavioral functions for the~     studied patients. The battery is composed of ten standardized neuropsychological tests,~     covering four domains sensitive to disease and treatment effects (executive function,~     attention, verbal memory, psychomotor speed), and QoL questionnaires.~      Expected results. This prospective cohort study aims to explore and evaluate patients with~     PCNSL who are newly-diagnosed by using a standard battery of neurobehavioral functions plus~     neuroimaging studies. It is anticipated investigators will investigate and correlate~     neurotoxicity indicators in newly-diagnosed patients with PCNSL who are treated with cranial~     radiotherapy combined with or without MTX-based chemotherapy according to the~     multidisciplinary treatment guidelines implemented at a single institute.~   "
30664|NCT02655731|"~     Aim of the present prospective, single-centre study is to determine the outcome after pure~     PVI using HeartLight™ in 100 patients with different extents of LA-LVA.~      The latter will be assessed by an electro-anatomical voltage map using a commercial 3D~     mapping system (CARTO, Biosense Webster).~   "
30665|NCT02655718|"~     The purpose of the study is to assess short and long term outcomes of acute coronary~     syndrome in patients with non obstructive coronary atherosclerosis, to optimize the~     algorithm for diagnosis and to evaluate its effectiveness~   "
30666|NCT02655705|"~     This study evaluates the performance of objective psoriasis severity assessment tool~     compared with a subjective assessment tool for the assessment of the improvement of~     psoriasis after oral cyclosporine A or methotrexate treatment.~   "
30667|NCT02655692|"~     The purpose of this study is to test the safety and efficacy of repeated doses of ketamine~     as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an~     active duty military and Veteran population.~   "
30668|NCT02655679|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream,~     twice-daily, for 28 days in otherwise healthy adult male and female patients with mild to~     moderate atopic dermatitis.~   "
30669|NCT02655666|"~     The purpose of the study is to observe/ collect clinical data, subject users' feedback, and~     device data to better understand the real-life usage and acceptance of the 722 Pump in type~     1 diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.~   "
30670|NCT02655653|"~     The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic~     acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac~     surgery, with the hypothesis that TA is more effective. The investigators also seek to~     further examine the clinical benefits and adverse effects profiles of epsilon-aminocaproic~     acid and tranexamic acid.~   "
30671|NCT02655640|"~     This research project has the overall objective to investigate the direction of the~     associations between illness perceptions, their influencing factors and health-related~     outcomes. Moreover, the investigators want to look at the direction of the associations~     between illness perceptions and health related outcomes such as psychological and physical~     functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis~     (SSc). The investigators want to know whether the outcome variables anxiety, depression,~     physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the~     patients' illness perceptions but also the illness perceptions of the General Practitioners~     (GP) and rheumatologists will be investigated. The researchers want to know if the doctors'~     perceptions have an impact on the physical and psychological functioning of the patient or~     vice versa. Much research in the field of illness perceptions is cross-sectional in nature~     which means that the direction of the relationships between variables is not known.~   "
30672|NCT02655627|"~     Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance~     and exercise has positive effects on glycemic control and cardiovascular disease (CVD)~     development in these patients. Encouraging physical activity and exercise with using~     internet-based technology provides; potential to reach more people via comparatively low~     cost, 24 hour accessibility to services and for clinician, more frequent communication~     ability with the patient. In literature, there is no study examined exercise training via~     internet in patients with Type 2 DM. For this reason, considering the lack of the~     literature, the investigators aimed to compare the effects of internet based combined~     exercise training on glycemic control, functional capacity and physical activity level with~     supervised group training in patients with Type 2 DM. The purpose of the study is to provide~     convenience of rehabilitation access, glycemic control, offer an alternative physiotherapy~     and rehabilitation service which can help to improve physical activity level and obtain~     quantitative data for the applicability and contribution of internet based exercise training~     in patients with Type 2 DM.~   "
30673|NCT02655614|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of GDC-0134 in~     patients with Amyotrophic Lateral Sclerosis (ALS).~   "
30684|NCT02655471|"~     This is a pilot study of intervention in a group of patients with tropical spastic~     paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus~     zidovudine in this group of patients.~   "
30694|NCT02655341|"~     Aims:~        -  evaluate the hydric status through bioimpedance spectroscopy in consecutive acute~          myocardial infarction patients referred for primary PCI;~        -  assessment of renal artery stenosis incidence through renal angiography in consecutive~          STEMI patients;~        -  fully characterize the complex hydration, metabolic and endothelial profile of these~          patients in the attempt to define the role played by dehydration in the complex~          dynamics of acute myocardial infarction.~   "
30674|NCT02655601|"~     This is a Phase 1/2 study of newly diagnosed patients with high grade glioma (HGG)~     undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation~     therapy and temozolomide has the potential not only to benefit the survival of high grade~     glioma patients but also to protect against deterioration of cognition and impairment of~     quality of life. In Phase 1 safety and tolerability of BMX-001 will be assessed using a~     two-stage Continual Reassessment Method (CRM). BMX-001 will be given subcutaneously first~     with a loading dose zero to four days prior to the start of chemoradiation and followed by~     twice a week doses at one-half of the loading dose for the duration of radiation therapy~     plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on~     cognition will also be assessed. Twenty-four patients will be randomized to the treatment~     arm that will receive BMX-001 while undergoing chemoradiation and 24 patients randomized to~     receive chemoradiation alone. The investigators hypothesize that BMX-001 when added to~     standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses~     in patients with newly diagnosed high grade glioma. The investigators also hypothesize that~     in Phase 2 of this study, the addition of BMX-001 will positively impact the overall~     survival and improve objective measures of cognition in newly diagnosed high grade glioma~     patients.~   "
30675|NCT02655588|"~     The primary purpose of this study is to examine how much change in depressive symptoms will~     be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to~     a control group at pre-, mid-point, and post-test assessments.~   "
30676|NCT02655575|"~     Brief Summary:~      The purpose of the present study is to examine the effects of a Group based intervention~     consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy~     (CBT) in patients with long--lasting vestibular dizziness. The study also aims to describe~     sociodemographic, physical and psychological characteristics in the patients, and to examine~     prognostic factors related to functional status and disability following participation in~     the intervention.~   "
30677|NCT02655562|"~     Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute~     cough refers to a cough of 3-8-week duration, and is typically refractory to standard~     anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials~     have evaluated therapeutic options for subacute cough. Airway inflammation is an important~     feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway~     inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl~     leukotrienes increase in virus infection. Airway inflammation induce epithelial cells~     produce iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast~     is a cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16~     and reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid~     dose, But A meta-analysis of the effectiveness of LTRA( leukotriene receptor~     antagonist,LTRA)in treating children with prolonged non-specific cough concluded that, with~     the lack of evidence, the routine use of LTRA in treating children with non-specific cough~     cannot be recommended. A randomised, placebo-controlled trial showed montelukast is not an~     effective treatment for postinfectious cough. Non-specialists or general practitioners of~     Japan prescribe LTRA very often, which increase. The aim is to research whether FeNO can be~     used as a biomarker to direct montelukast treatment and optimize treatment regimen of~     sub-acute cough.~   "
30678|NCT02655549|"~     The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.~   "
30679|NCT02655536|"~     This is an open-label, randomized, multicenter phase II study conducting in 3 medical~     centers in Asia. Patients will receive erlotinib in combination with bevacizumab or~     erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic~     brain metastases.~      The primary objective is to compare the systemic progression-free survival (PFS) to~     bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who~     have asymptomatic brain metastases.~   "
30680|NCT02655523|"~     Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic~     procedure in headache patients. GON blocks have been shown to be effective in the treatment~     of a variety of headaches including occipital neuralgia, migraine, vascular headache,~     cluster headache, cervicogenic headache, and post-concussive headache. Local anesthetic and~     steroids have been successfully used for diagnostic and or therapeutic nerve pain such as~     lumbar radicultis with great success. Dexamethasone is a water soluble steroid, when~     combined with local anesthetic; it may increase the analgesia of block duration relative to~     its pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid~     has a slower onset time but may provide anti-inflammatory effects up to several weeks.~     Investigators want to investigate to see if there exists a difference in reported pain~     intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with~     bupivacaine) which may provide a greater reduction in reported pain intensity relief may~     allow the patient to undergo fewer interventional procedures.~   "
30681|NCT02655510|"~     Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with~     long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients~     who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis,~     marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of~     portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However,~     milder forms of alcoholic hepatitis often do not cause any symptoms.~      Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use~     continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months,~     sometimes without permanent sequelae but often with residual cirrhosis.~      F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human~     Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under~     development is intended to treat patients with graft vs host disease (GvHD) after bone~     marrow transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic~     liver disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current~     investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD~     patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652~     treatment by intravenous infusion (IV).~      IL-22 is a member of the IL-10 family of cytokines which control bacterial infection,~     homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its~     antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that~     have been demonstrated in various experimental systems.~   "
30685|NCT02655458|"~     The purpose of this study is to explore the combination of Elotuzumab in combination with~     autologous stem cell transplantation and lenalidomide maintenance to see what side effects~     it may have and how well it works for the treatment of symptomatic multiple myeloma~     diagnosed and treated with induction therapy in the past year.~      Induction therapy is the first phase of treatment for multiple myeloma. The goal of~     induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone~     marrow and the proteins that the plasma cells produce. Induction therapy is usually given~     for 3-4 weeks.~      An autologous peripheral blood stem cell transplant is a procedure in which immature stem~     cells are collected and stored for future use. A high dose of chemotherapy is given to the~     patient to destroy myeloma cells, and the patient's stem cells are replaced.~      The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608.~     Elotuzumab is a manufactured protein directed against a target found on multiple myeloma~     cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and~     cyclophosphamide, the drugs used during stem cell collection and transplant, are also~     approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and~     is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an~     FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs~     to treat multiple myeloma.~   "
30686|NCT02655445|"~     Setup of comparative trial The goal of this study is to determine whether one surgical~     treatment for chronic subdural hematoma is better than the other. Patients with a clear~     indication for drainage of subdural hematoma (as stated under Surgical options) will be~     randomized into three groups. One group will receive twist drill craniostomy followed by~     drainage during 48 hours. One group will undergo burr hole drainage (single if possible,~     double if necessary) with irrigation and drainage during 48 hours postoperatively. One group~     will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible~     membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by closed~     system draining during 48 hours. Postoperative results and complications will be compared~     between the three groups.~   "
30687|NCT02655432|"~     Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk~     factors with the use of the Spot photoscreener. The photoscreener results will be compared~     to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the~     performance of the spot photoscreener in the haitian children population. Secondarily, this~     study will gather epidemiological information on vision problems in the haitian children~     population.~   "
30688|NCT02655419|"~     Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the~     treatment of hospitalized adults with cIAI~   "
30689|NCT02655406|"~     This study will be looking at the effect of compression therapy in patients having~     endovenous treatment for varicose veins using foam sclerotherapy. Patients will be~     randomised to either the compression group (group A) or the no compression group (group B).~      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as~     the cost effectiveness of each intervention will be assessed.~   "
30690|NCT02655393|"~     Part A:~      The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly~     male and female volunteers. Each subject will be randomized for two subsequent doses in~     three cohorts.~      Part B:~      The study is a double-blind, randomized, multiple ascending doses study in 36 healthy~     elderly male and female volunteers. Subjects will be randomized to receive study product or~     placebo for 28 days.~   "
30691|NCT02655380|"~     Ketamine and opioid are known to improve the intubating condition, respectively. Combination~     of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in~     complementary manner. Therefore, the combination use of ketamine and remifentanil could be~     useful for acceptable intubating condition in the general anesthesia without the use of~     neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2~     mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine~     induction dose for intubation without neuromuscular blocking agent. The investigators focus~     on remifentanil dose using Dixon's up and down method.~   "
30692|NCT02655367|"~     This crossover study is designed to compare the gastric layering and rates of emptying and~     by inference rates of digestion of two different porridge meals prepared from either finely~     milled or flaked oats. On each of two study days, a total of 9 MRI scans will be taken, I~     baseline and 8 post meal, to assess gastric layering and emptying over three hours. Blood~     samples will also be taken periodically over the same period in order to determine changes~     in concentrations of circulating glucose, insulin and key gastrointestinal hormones.~     Participants will also be asked to complete a questionnaire at predetermined times to assess~     feelings of satiation.~   "
30693|NCT02655354|"~     The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems~     Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic~     clinical trial demonstration project that directly informs national trauma care system~     policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD)~     and related comorbidity. Each year in the United States (US), over 30 million individuals~     present to trauma centers, emergency departments, and other acute care medical settings for~     the treatment of physical injuries. Multiple chronic conditions including enduring PTSD,~     alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic~     symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery~     disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with~     and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care~     management treatment models for PTSD and related comorbidities exist. These care management~     models have the potential to be flexibly implemented in order to prevent the development of~     chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability~     in survivors of both TBI and non-TBI injuries; care management models may also be effective~     in mitigating the impact of the acute injury event on symptom exacerbations in the large~     subpopulation of injury survivors who already carry a substantial pre-injury burden of~     multiple chronic medical conditions.~   "
30695|NCT02655328|"~     This study will determine the pharmacokinetic profile of the salbutamol concentration in the~     urine while athletes are resting or during exercise.~   "
30697|NCT02655302|"~     Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of~     the airways linked to environmental exposure. The chronic course of COPD is often~     interrupted by acute exacerbations which have a major impact on the morbidity and mortality~     of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%).~     Moreover, airway bacterial colonization linked to an increased susceptibility is observed in~     COPD patients. Effective Th17 immune response is needed to develop a good response against~     bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22~     response to bacteria in COPD leading to airway bacterial colonization and infection.~   "
30698|NCT02655289|"~     Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and~     thus, pain control plays a central role in palliative care.~      Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for~     patients who experience suboptimal pain control. However, the evidence for the efficacy of~     TENS in cancer patients is not unambiguous.~      The present study is a double blind, placebo-controlled cross-over trial with a short-term~     follow-up.~      The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain~     reduction in advanced cancer patients.~      The secondary aim is the explorative identification of subgroups that benefit or do not~     benefit from TENS.~   "
30699|NCT02655276|"~     This study is designed to investigate effects on attentional performance and motoric~     activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo~     after treatment with t.i.d. sublingual doses over 3 weeks each.~      The primary objective of the study is to determine the effects on attentional performance~     and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared~     to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with~     low attentional performance and high motoric activity.~      A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance~     and high motoric activity will be enrolled in this study. The prepuberal status will be~     determined by Tanner stages ≤ 3.~   "
30700|NCT02655263|"~     Background: Humans naturally produce ketone bodies under daily living conditions. The main~     ketone bodies are two functioning acids, beta-hydroxybutyric acid (3-OHB) and acetoacetate,~     and the pH-neutral, but odorous, acetone. In the fed state, level of 3-OHB is suppressed to~     an almost unmeasurable level while, in the fasted state, it rises to 0.1-0.5 millimoles~     (mM). Main regulation of ketone synthesis is the abundance of sugars and resulting~     adaptations in insulin secretion. Thus, ketone bodies are formed when sugar is not readily~     available and insulin is suppressed. This picture is, to a certain degree, seen in acute~     inflammatory states and, indeed, during starvation, where level of 3-OHB increases to 5-8~     mM.~      Hypothesis:~        1. Ketone bodies changes the insulin sensitivity and substrate metabolism in human~          subjects~        2. Ketone bodies changes the GH signaling in muscle and adipose tissue~      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in~     signaling pathways and insulin sensitivity during GH infusion and concomitant ketone bodies~     infusion among healthy subjects.~   "
30701|NCT02655250|"~     This is a validation study to compare proposed field collection methods with a gold standard~     collection technique for microbiome analysis of stool and breast milk samples.~   "
30702|NCT02655237|"~     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally~     once daily for 12 weeks, compared with leuprorelin injection (once/4 weeks, 1.88 mg or 3.75~     mg SC/time) in participants with uterine fibroids.~   "
30703|NCT02655224|"~     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally~     once daily for 12 weeks, compared with placebo in participants having pain symptoms~     associated with uterine fibroids.~   "
30704|NCT02655211|"~     This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2)~     laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and~     will determine the optimal sequence and timing of lasers and usual care.~   "
30705|NCT02655198|"~     In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox~     Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At~     baseline and at the end of the study, ECG and ultrasound of the heart will be performed as~     part of the safety follow up.~   "
30706|NCT02655185|"~     The purpose of this study is to determine whether lipid levels are related with incidence of~     atrial fibrillation in Patients with chronic heart failure.~   "
30707|NCT02655172|"~     Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of~     contact with reality is frequently found. A fragmentation of motor and sensory perceptions~     could be held responsible. However, automatic integration between perception and action is~     the necessary condition to be in relationship with the world. Affordance is the~     experimental link between object perception and potentially associated actions (Gibson,~     1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker & Ellis~     sensory motor compatibility task (1998), with a modified response device (responses given~     with grasp), we study the impact of motor activation on these affordance effects. In this~     study, a group of controls will also be included in order to understand, as precisely as~     possible, the mechanisms involved (i.e., interference between the perception of the object~     and the response gesture).~   "
30708|NCT02655159|"~     This is a national, multicenter, retrospective, observational post-authorization study~     (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up~     to the start of the study. In each case, only data from before the start of the study will~     be obtained in order to ensure they are retrospective in nature, thus reflecting the regular~     use of nab-paclitaxel in clinical practice and avoiding interference with the physician's~     clinical practice.~      To ensure the observational nature of this study, these data will be collected whenever they~     are available in the patient's medical record, and so no diagnostic or therapeutic~     intervention outside regular clinical practice will be used.~   "
30709|NCT02655146|"~     The aim of the present prospective randomized controlled study was to determine the effects~     of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen~     embryo transfer (FET).~   "
30974|NCT02651662|"~     This is an open-label, multicenter, dose escalation study of REGN2810 and REGN1979 in~     patients with lymphoma or Acute Lymphoblastic Leukemia (ALL). The study treatment period~     will be from 6 to 12 months, depending on how an individual patient responds to treatment.~     The follow-up period will be 6 months for all patients.~   "
30710|NCT02655133|"~     IgM-enriched immunoglobulins (IgGAM; Pentaglobin ® ) are new therapy for sepsis and septic~     shock since they support immune system especially in case of  immunoparalysis . However~     IgGAM isn't commonly prescribed, few centres use it as routine in severe infections and~     there aren't any guidelines to determine how and when to use them.~      Microcirculatory dysfunction is a crucial aspect in the pathogenesis of sepsis-induced organ~     dysfunction, resulting in hypoperfusion and tissue hypoxia. Unpublished clinical data~     suggest a beneficial effect of IgGAM at microvascular level proved with near infrared~     spectroscopy and Vascular occlusion test (VOT).~      This study is a double blind phase II prospective randomised controlled trial that will~     include patients admitted to the Intensive Care Unit of the University Hospital Ospedali~     Riuniti of Ancona, after no more than 24 hours from development of severe sepsis or septic~     shoc.~      Patients will be randomized into two groups (treaties and controls): patients in group of~     the treaties will be submitted to infusion of IgGAM conjugate (Pentaglobin ®) at dosage of~     250 mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. The controls will~     receive equal amount of physiological NaCl solution (0.9%) as placebo. Neither the patient~     nor the staff nurses and MD will be aware of the group and of the treatment applied. IgGAM~     solutions or NaCl 0.9% will be provided by the hospital pharmacy in similar bags. The~     remaining treatments will not be changed in any way and will be at the discretion of the~     doctor who's in charge of the patient. All patients of the two groups will receive the~     optimal therapy for their conditions, according to good medical clinical practice (GMP),~     with appropriate antibiotic therapy, vasoactive and infusional therapy~   "
30711|NCT02655120|"~     The main objective of the study is to evaluate the effectiveness of the injection of bone~     marrow unconcentrated more R BMP 7 to repair necrosis of the femoral head with stage I-III~     classification FICAT.~   "
30712|NCT02655107|"~     Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective~     congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared~     to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care~     (GEM 3500 premiere).~   "
30713|NCT02655094|"~     Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some~     cases severe complications, sometimes causing extracorporeal life support. The investigators~     have observed over several years 5 cases of instantaneous postoperative severe pulmonary~     edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery~     procedure.~   "
30714|NCT02655081|"~     To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with~     a preoperative high-arginine nutritional supplement. The investigator will measure patient~     adherence to the regimen, tolerability of the supplement and feasibility of supplementation.~     Secondary outcome measures will include differences in length of stay and complication rate~     between groups.~   "
30715|NCT02655068|"~     The null hypothesis is that patients screened by PET/CT will not have detection of disease~     recurrence any earlier than those screened by CT alone. The alternative hypothesis is that~     PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT~     surveillance. Furthermore, to reject the null hypothesis, earlier detection must be~     associated with a cause-specific survival improvement of 10%. Primary endpoints will include~     time from the completion of definitive therapy to diagnosis of recurrent disease, and~     absolute survival within 3 years after completion of initial therapy. Duration of survival~     between diagnosis of recurrence and subsequent death will not be a primary endpoint because~     the investigators expect that PET/CT will offer an opportunity for earlier recognition of~     recurrence and be subject to lead-time bias. Duration of survival will be measured from~     completion of primary treatment until death. Note: the presence of residual disease at~     surgical consolidation does not constitute a recurrence event.~   "
30716|NCT02655055|"~     A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be~     performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood~     donors. The primary outcome measure will be clinically significant decline in BMD at the~     lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).~   "
30717|NCT02655042|"~     The primary purpose of this study is to assess the long-term safety profile of RCT-01~     injections as compared to placebo injections. This study will also measure the long-term~     impact these injections will have on tendon structure and function and the symptoms of~     Achilles tendinosis.~      This is study is designed to follow participants who have completed participation in a~     clinical trial where they received injections of either RCT-01 or placebo in the Achilles~     tendon. No clinical interventions will be performed as part of study procedures.~      The day of study entry (Visit 1) will be coordinated with the participant's final visit in~     the earlier clinical trial. All participants will return to the clinic for repeat~     assessments of their Achilles tendinosis and overall health 6, 12 and 18 months after study~     entry. Furthermore, they will complete 'telephone visits'; during which they will report~     information on their overall health; 3, 9, and 15 months after study entry. Total duration~     of patient participation is approximately 18 months.~   "
30718|NCT02655029|"~     The main objective of this study is to record, in routine clinical practice, patients'~     adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during~     4 months treatment.~   "
30719|NCT02655016|"~     This study is a double-blind, randomized (2:1 niraparib:placebo), placebo-controlled study~     in patients with ovarian cancer who have HRD-positive tumors, as identified with a~     centralized HRD test, and are at high risk for progressive disease (PD), as identified by~     the stage of cancer and previous response to surgery. Patients must have received at least 4~     cycles of a front-line platinum-based regimen with a physician-assessed response of CR or PR~     (no measurable lesion >2 cm). Additionally, patients must have a normal or >90% decrease in~     cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess~     whether maintenance treatment with niraparib will extend PFS in this population.~     Stratification factors will include best response during the front-line platinum regimen~     (CRand PR).~   "
30720|NCT02655003|"~     Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the~     course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment~     of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical~     framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the~     effects of TIME on NPS in nursing homes patients with dementia and the implementation~     process at staff and organization level.~   "
30721|NCT02654990|"~     The purpose of this study is to investigate the safety and efficacy of three different~     regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex~     and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in~     a randomized, 3-arm parallel design. This study will also assess the impact of administering~     s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly~     starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75~     years of age will receive for the entire treatment period s.c. BTZ weekly (in combination~     with PAN and Dex) until disease progression.~      Patients will be treated until disease progression or until they discontinue earlier due to~     unacceptable toxicity or for other reasons.~      Patients who discontinued study treatment for reasons other than disease progression will be~     followed for efficacy every 6 weeks.~      All patients will be followed for survival until the last patient entering long-term~     follow-up has completed a 3 year survival follow-up or discontinued earlier.~   "
30722|NCT02654977|"~     The study investigators' aim is to determine the long term safety and efficacy of~     Metreleptin (Myalept,) in promoting amelioration of metabolic abnormalities in patients with~     all forms of partial lipodystrophy. Patients will be offered this protocol under the~     following condition: Subjects have completed University of Michigan research protocol~     MB002-014 and have shown improved clinical benefit as judged by clinical criteria set forth~     in this protocol.~   "
30723|NCT02654964|"~     A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who~     have GBM that has recurred or progressed following prior radiation therapy and TMZ.~   "
30724|NCT02654951|"~     The project targets stroke survivors to investigate the effect of augmented feedback (using~     robotic force cues and visual feedback) on their upper limb reaching patterns and trunk~     compensatory movements.~   "
30725|NCT02654938|"~     Phase I single-blinded, randomized, placebo-controlled trial evaluating safety,~     tolerability, pharmacokinetics and pharmacodynamics of single injections of ascending doses~     of investigational drug product Mobilan (М-VM3) administered directly into the prostate of~     patients with prostate cancer.~   "
30726|NCT02654925|"~     In order to design new programs to help prevent weight gain, promote successful and~     sustainable weight loss, and help treat diseases related to obesity, the investigators need~     a better understanding of why accumulating fat in certain regions of the body is bad for~     health. It is known that not all fat cells are the same, but it was recently discovered that~     some fat cells may arise from stem cells that come from the bone marrow (bone marrow~     progenitors), a previously unrecognized origin. This discovery has been paradigm shifting,~     because dogma has long held that all white fat cells arise from fat tissue resident~     mesenchymal stem cells. This is also important because fat cells arising from the bone~     marrow lineage may be linked to worse health outcomes. The aim of this study is to determine~     if cells that were not previously believed to contribute to fat generation in humans are~     indeed capable of becoming fat cells. To answer this question the investigators will take~     samples of cells from the blood and the fat tissue of younger and older men and women,~     isolate the cells that came from the bone marrow and grow them in culture to determine if~     they will turn into fat cells. The results of this investigation may reveal potential~     mechanistic targets for future therapies to reduce the negative health outcomes associated~     with obesity related chronic diseases.~   "
30727|NCT02654912|"~     This study is designed to compare the effectiveness of reactive focal drug administration~     (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat~     (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and~     eliminating malaria transmission as measured through achieving zero seropositivity in~     children under five in Southern Province, Zambia. These two strategies are potential~     candidates for expanded malaria operational surveillance and elimination for low malaria~     transmission areas.~   "
30728|NCT02654899|"~     The current study is the first clinical trial proposed with PF-06815345. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     single oral doses of PF-06815345 to healthy adult subjects.~   "
30729|NCT02654886|"~     The purpose of this research study is to determine if exercise will help improve muscle~     strength, endurance, and quality of life in individuals with Pompe disease. This is a~     research study to further define the outcome of patients with Pompe disease treated with a~     combined diet and exercise therapy.~   "
30730|NCT02654873|"~     Cholecystectomy has been made with benign conditions usually. The aim of this study is to~     compare the macroscopic evaluations of the cholecystectomy specimens with it's~     histopathological examinations.~   "
30731|NCT02654860|"~     The objective of the study is to investigate the efficacy and safety of a single intrathecal~     injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared~     to placebo solution, for post-operative analgesia of hip replacement surgery performed under~     spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4~     treatment groups (15 patients per group) to receive either one of the 3 single doses of~     paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution)~     by intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration,~     all patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤~     160 cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between~     paracetamol IT and bupivacaine IT administrations should not exceed 2 min.~      The study will include a screening phase (Visit 1, Days -21/1), a treatment phase~     (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a~     follow-up phase including an observation period (Visit 3, from Day 1 after surgery until~     discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be~     assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24,~     27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a~     0-100 mm VAS.~   "
30745|NCT02654678|"~     Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart~     failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than~     12 years of age at recruitment into the preceding short-term pharmacokinetic~     (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all~     children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as~     acceptability and palatability assessments in children still under enalapril Orodispersible~     Minitablet (ODMT) treatment.~   "
30732|NCT02654847|"~     Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery~     (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and~     vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension~     includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor~     used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac~     output, which may be a concern in an already compromised fetus. Norepinephrine is commonly~     used in high concentrations in intensive care and recent studies have suggested that in low~     concentrations it may be a better alternative to phenylephrine in elective CD, as it does~     not reduce the maternal heart rate or cardiac output. The optimum bolus dose of~     norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been~     elucidated. The investigators propose this study to determine the dose that would be~     effective in 90% of patients (ED90).~      A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent~     hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of~     approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately~     6 µg, given that the current phenylephrine bolus dose at the investigators' institution is~     approximately 100 µg.~   "
30733|NCT02654834|"~     The purpose of this study is investigate to the effect(s) of chronic occupational exposure~     to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the~     generation of the biochemical markers) in operating room staff, with different levels of~     exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care~     Staff), and to determine the relationship between the degree of oxidative stress and~     psychological stress, as assessed by validated psychometric measures.~   "
30734|NCT02654821|"~     Patients with stage IV melanoma (also eye melanoma) will be treated with TCR transduced~     cells.~   "
30735|NCT02654808|"~     The purpose of this study is to compare CO2 absorption during gynecologic laparoscopy using~     the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal~     pressures of 10 and 15 mmHg.~      The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic~     laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant~     decrease in CO2 absorption, while maintaining adequate visualization of the operative field~     for safe completion of surgery.~   "
30736|NCT02654795|"~     Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF).~     Numerous factors predisposing to peripheral embolism in patients with AF have been well~     defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation~     minimizes the risk attributable to known risk factors, stroke may still occur. Thus,~     unknown risk factors may play an important role in stroke risk stratification in patients~     with AF. The investigators assume that one of the important unknown risk factor is left~     atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after~     ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at~     the time of stroke. The control group will consist of 100 patients scheduled for AF ablation~     without a history of stroke or TIA.~   "
30737|NCT02654782|"~     Looking at individual total fluid volume and alveolar-arterial gradient with 5% human~     albumin and Lactated Ringer's in the perioperative cardiac surgical patient.~      Our hypothesis is that the individual total fluid volume and alveolar-arterial gradient will~     be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac~     surgical patient.~   "
30738|NCT02654769|"~     The objective of this study was to evaluate the safety and therapeutic equivalence of~     generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of~     the efficacy of these two products over the vehicle gel in the treatment of Actinic~     Keratosis (AK) on the trunk or extremities.~   "
30739|NCT02654756|"~     While there are proven therapies that slow CKD progression, these therapies can at times be~     harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD~     would be extremely valuable. The short term versus lifetime risk of CKD progression should~     be taken into account when making risk based clinical decisions. In a representative CKD~     practice, the investigators compared the short term and lifetime risk assessment in our~     stage 3 CKD patients to determine whether decisions based on a short term risk assessment~     would underestimate the lifetime risk of CKD progression. The investigators also applied the~     short term risk assessment to our stage 4 CKD patients to determine the frequency with which~     ESRD risk may be overestimated in CKD stage 4.~   "
30740|NCT02654743|"~     This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior~     in children with ASD and the correlation between behavior change and urinary metabolites.~     The goal is to determine a potential mechanism of action of SF in this population.~   "
30741|NCT02654730|"~     The purpose of this study is to evaluate the tolerability and safety of increasing doses of~     primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.~   "
30742|NCT02654717|"~     The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on~     the face and scalp during 8 weeks of treatment. The study will also look at any unwanted~     effects of the study drug.~   "
30743|NCT02654704|"~     To follow longitudinally healthy and immune-compromised responses to pneumococcal~     vaccination, in 60+ individuals towards the development of personalized medicine~     implementation (minimum enrollments in 2 age categories: young adults[18-25], older adults~     [55+], within each category: 10+ healthy, 10+ asthma, 10+ immune-compromised [e.g. leukemia~     or autoimmune disorders]). The approach will profile thousands of molecular components~     utilizing high-throughput technologies and integrate these data to obtain personalized~     immune response to vaccination. The study will provide insights into immune response~     mechanisms specific to asthmatics, immune compromised and healthy individuals, as well as in~     response to vaccination. Additionally the differences in dynamic response across the two age~     groups will be investigated.~   "
30744|NCT02654691|"~     This is a clinical study which is a follow-up of a previous prospective questionnaire study.~     All patients who previously participated in the study will receive a new questionnaire and~     will be invited for a clinical examination.~   "
31010|NCT02651194|"~     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with~     the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection~     and chronic renal impairment.~   "
30746|NCT02654665|"~     Non-alcoholic fatty liver disease (NAFLD) is defined by presence of hepatic steatosis (fat~     accumulation in liver cells), either by imaging or by biopsy and absence of causes for~     secondary hepatic fat accumulation such as significant alcohol consumption, medications, or~     hereditary disorders. In the majority of patients, NAFLD is associated with risk factors for~     cardiovascular disease such as obesity, diabetes mellitus, and high cholesterol, and may~     lead to irreversible liver damage. Non-alcoholic steatohepatitis (NASH) is a more severe~     form of NAFLD and is present in up to 30% of obese adults. NASH is defined by hepatic~     steatosis and inflammation with hepatocyte injury with or without fibrosis (hardening of the~     liver).~      The prevalence, morbidity and mortality of NAFLD is increasing, particularly in the~     Asia-Pacific region where there will be an estimated 300 million obese people by 2030.~     Weight loss is the first-line treatment for NAFLD in obese individuals, but the utility of~     lifestyle modification with diet and exercise is limited by difficulties in sustaining~     compliance and by eventual weight regain. Bariatric (weight loss) surgery produces the~     greatest amount of weight loss but is limited by cost, patient acceptance, and~     complications. The efficacy of drugs for NASH, such as vitamin E and medication to lower~     cholesterol and glucose, remains unclear. Liraglutide, a glucagon-like peptide (GLP-1)~     analogue, is an injectable medication which has been shown to induce weight loss and lower~     glucose in obese adults. There is little information on the effects of GLP-1 analogues on~     NASH, particularly in comparison to other modalities of weight loss such as surgery. This~     study aims to compare the efficacy and safety of lifestyle modification, liraglutide and~     surgery, for weight loss in conjunction with reducing severity of NASH, and for insulin~     resistance, high cholesterol and other cardiovascular risk factors.~   "
30747|NCT02654652|"~     The purpose of this study is to determine whether the symbiotic use in patients with head~     and neck cancer impact on intestinal function after surgical treatment.~   "
30748|NCT02654639|"~     Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC~   "
30749|NCT02654626|"~     This is a randomized, single-blind, placebo-controlled, sequential parallel-group and~     multiple ascending dose (MAD) study to evaluate the safety, tolerability and~     pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose~     level before progressing to the next higher dose.~   "
30750|NCT02654613|"~     This study addresses the highest ranking health research priority in South Africa, which is,~     to develop and test optimal models of HIV-TB service delivery that will enhance retention,~     adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan~     Africa, a region with limited health budgets, infrastructure, human resources, and~     suboptimal TB infection control practices. There is compelling clinical evidence suggesting~     that integrating HIV and TB services saves lives and presents an effective and efficient use~     of resources directed at optimizing health outcomes. Quality improvement (QI) methods are~     increasingly being used to systematically test and incorporate local ideas into strategies~     for reliable implementation and scale up. This trial is designed to test a practical,~     implementable and affordable strategy aimed at improving HIV-TB service integration to~     reduce TB and HIV associated deaths. This is a cluster randomized controlled trial, which~     evaluates and tests the effectiveness of implementing a QI model to integrate HIV-TB service~     delivery in primary health care clinics, on reducing morbidity and mortality in TB-HIV~     co-infected patients. This study will be conducted in 2 districts, Ugu and uThungulu, in~     KwaZulu-Natal, South Africa. The model of integrated care delivery for TB and HIV using the~     QI method offers a systems approach to care delivery to directly enhance treatment outcomes~     by enabling comprehensive effective care designed around the patients journey from entry to~     the clinic, through screening treatment initiation, treatment completion, and retention in~     care that is directed at the goals of cure for TB, effective sustainable HIV viral~     suppression and reduced HIV associated TB mortality as the main health impact. The~     scalability of the model, once proven effective, is the critical element that makes it~     increase population coverage of quality diagnosis and treatment of HIV-TB co-infection. QI~     methods promote front line staff engagement in identification and rapid testing of local~     implementation solutions to gaps in performance of processes of care along the steps of the~     patient journey. Gaps in care are identified through continuous feedback on a core set of~     indicators collected monthly as routine collection of data.~   "
30751|NCT02654600|"~     the decrease in thoracopulmonary compliance after cardiac surgery is well known . The~     investigators hypothesize that the major factor determining pulmonary outcome after cardiac~     surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and~     that this alteration is due to CBP itself through pulmonary blood emptying.~   "
30752|NCT02654587|"~     The aim of this study is to determine if the Investigational Medicinal Product Tedopi~     (OSE2101) is more effective than standard treatment in treating patients with stage IIIB~     NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.~   "
30753|NCT02654574|"~     In France, about 1 million people 65 and older are diagnosed with dementia syndrome~     characterized by cognitive decline and impairment of functional capacity. The assessment of~     the level of functional autonomy is therefore an essential step in monitoring patients in~     Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients'~     ability to perform daily tasks.~      In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during~     a face-to-face interview between their primary caregiver and a nurse, using the IADL~     questionnaire. This assessment should be renewed every year. The IADL questionnaire is part~     of the information that the memories consultations shall transmit to the Alzheimer's~     National Bank (BNA).~      However, current practice has shown that the systematic collection is problematic in the~     organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in~     order to measure changes in the level of autonomy during the disease, and improve the~     completeness of this collection. A study is conducted with the main objective to measure the~     reliability of the assessment of IADL questionnaires conducted during a telephone interview~     with the caregiver of the patient, in comparison to the reference mode: the face-to-face~     interview with the caregiver.~      Materials and methods The experimental design of the study will be a randomized crossover~     trial (crossover), including 394 patients divided into two branches. In the first part, the~     collection of the IADL questionnaire will be performed according to the reference method in~     the consultation (face-to-face interview with the nurse), the measurement will be repeated~     at 1 month intervals by phone. In the second part the sequence of execution modes will be~     reversed. The reliability of the measurement of the level of autonomy will be studied by~     comparing repeated measurements based on handover modes. The correspondence between the~     repeated measures will also be considered in terms of patient characteristics. The~     feasibility of administration of the questionnaire by phone mode will be evaluated.~      Expected results The mode of administration by phone should allow to obtain a reliable~     measurement of the level of patient autonomy when the administration is carried out in a~     standardized way. The study should also identify patients and situations for which this~     method of administration by phone may be appropriate.~   "
30754|NCT02654561|"~     The primary objective of this study is to estimate the efficacy of unfractionated~     heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to~     estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association~     for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of~     UFH in severe sepsis patients with suspected DIC.~   "
30755|NCT02654548|"~     To investigate whether women with polycystic ovary syndrome who are post-partum excrete~     higher levels of sebum in comparison to healthy controls due to high levels of androgens.~   "
30768|NCT02654379|"~     This study is to characterize the indications for which rituximab is being used and to~     evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication~     for non-oncology conditions at infusion centers. The study involves the retrospective chart~     review of rituximab users' medical records in non-oncology indications as well as a survey~     to collect information on participant characteristics, and will include questions about~     participant knowledge on the risk of infections, participant receipt and review of the PAC,~     and any actions the participant has taken as a result of receiving the PAC.~   "
30821|NCT02653677|"~     The purposes of the present study are to determine the glycemic and insulinemic responses,~     the satiety rate and the postprandial plasma concentrations of free fatty acids,~     triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted~     bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale~     retail distribution; handcrafted bread with organic einkorn flour and a commercial wheat~     bread.~   "
30756|NCT02654535|"~     Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts,~     cashews, hazelnuts, macadamia nuts) (herein referred to as nuts) are a good source of~     unsaturated fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been~     associated with reduced cardiovascular disease risk and claims for this association have~     been permitted by the FDA; however, intake of tree nuts is low in Canada. One of the~     barriers to increasing the consumption of nuts is the perception that they may contribute to~     weight gain more than other healthy foods owing to their high energy density. The evidence~     supporting this concern, however, is lacking. In a series of earlier systematic reviews and~     meta-analyses, we have shown that nuts improve glycemic control and metabolic syndrome~     criteria, findings which run contrary to any expected weight gain. However, it remains~     unclear whether nuts have an increasing, neutral, or even decreasing effect on body weight.~     To address the uncertainties, the investigators propose to conduct a series of systematic~     reviews and meta-analyses of the totality of the evidence from controlled trials and~     prospective cohort studies to investigate the effect of nut consumption on body weight and~     adiposity. The findings generated by this proposed knowledge synthesis will help improve the~     health of consumers through informing evidence-based guidelines and improving health~     outcomes by educating healthcare providers and patients, stimulating industry innovation,~     and guiding future research design~   "
30757|NCT02654522|"~     The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase~     (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA)~     dermal fillers.~   "
30758|NCT02654509|"~     This study is being conducted to collect safety and immunogenicity data for the EEE vaccine.~   "
30759|NCT02654496|"~     The purpose of this study is to investigate mechanisms responsible for weight change in~     patients who have undergone weight loss surgery. Specifically, we will compare the gut~     microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS~     in three groups of subjects: 3-5 years post gastric bypass patients who experienced~     sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight~     loss, and a control group who has not had a weight loss surgery and are of similar age,~     gender, body mass index as the gastric bypass groups.~   "
30760|NCT02654483|"~     Itch, or pruritus, is the most common complain reported by patients with epidermolysis~     bullosa (EB) of all subtypes, and there is no current effective treatment. Itch often~     triggers scratching that creates new wounds and increases EB disease severity. This study~     aims to target the physiological mechanisms of pruritus. Substance P is a major mediator of~     pruritus and binds to the receptor neurokinin-1 (NK1), which is expressed in the central~     nervous system and the skin. VPD-737 (serlopitant), a drug that inhibits the NK1 receptor,~     has been shown to reduce severe itch in a previous study of 257 adult patients with chronic~     pruritus. The investigators are now testing VPD-737 in 14 patients with EB in a Phase II~     randomized, placebo-controlled, double-blinded clinical trial. Our goals is to determine~     whether daily oral administration of VPD-737 (5 mg) is effective and safe in adolescents and~     adults with EB.~   "
30761|NCT02654470|"~     The WATCHMAN™ Left Atrial Appendage Closure (LAAC) Technology is intended to prevent~     thrombus embolization from the left atrial appendage and reduce the risk of life-threatening~     bleeding events in patients with non-valvular atrial fibrillation who are eligible for~     anticoagulation therapy or who have a contraindication to anticoagulation therapy.~   "
30762|NCT02654457|"~     The purpose of the study is the identification and semi-quantification of Ki-67 protein~     expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual~     reading of the same slides.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ER/PR IHC stained samples~   "
30763|NCT02654444|"~     The purpose of the study is the identification and quantification of protein expression~     level in breast cancer tissues.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying her2 immunohistochemical (IHC) stained samples.~   "
30764|NCT02654431|"~     The purpose of the study is the identification and quantification of proteins expression~     level in breast cancer tissues.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ER/PR IHC stained samples.~   "
30765|NCT02654418|"~     SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift~     of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to~     excision with a snare.~   "
30766|NCT02654405|"~     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel~     treatment for cognitive deficits in schizophrenia (SZ).~      The proposal consists of a small preliminary open label study to assess tolerability and~     side effects of sodium butyrate in schizophrenic patients receiving antipsychotic treatment,~     followed by a larger double-blind study of the effects of sodium butyrate on cognitive~     function and symptoms in SZ patients who are not in an acute exacerbation of the primary~     symptoms and show continued cognitive deficits. Secondary aims will be to evaluate its~     effects on improving symptoms and functioning in SZ, and the relationship of the drug's~     clinical effects to epigenetic and inflammation related biochemical changes.~   "
30767|NCT02654392|"~     Many studies in the past three decades have examined the beneficial effects of omega-3~     polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty~     acids, specifically omega-3 and omega-6, on health have been well-studied but most of the~     study to date has been on animal not plant sources and much less is know about their effects~     on exercise performance. Additionally, while positive effects have been detected for~     sedentary populations or those that are at risk, well-trained athletes generally have not~     had established advantages in taking supplements for omega-3 and omega-6 oils. There is~     evidence that a specific ratio of omega-6 to omega-3 is most beneficial for the human body~     with regards to cardiovascular and mental health. In this study, participants randomized to~     either a plant supplement group (pureform omega; containing Flax, Evening Primrose,~     Sunflower, Coconut & Pumpkin oils; Natural Product Number = 80050660) or placebo~     (isoenergetic sugar pills) will be subjected to both a time trial and a high intensity~     interval bout, where their performance and power output will be analyzed. Blood lactate and~     glucose concentration, as well as oxygen consumption and carbon dioxide production will also~     be examined to determine if there is a change in on fat oxidation after supplementation.~   "
30769|NCT02654366|"~     Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies~     are often thwarted by strong social networks that reinforce substance use and other risky~     injection use and sexual behaviors. The proposed study addresses this important problem by~     evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group.~     This structured intervention works with injection drug users and at least one drug-free~     family or friend to mobilize social support, teach HIV risk reduction skills, develop~     treatment readiness, and support participation in community activities designed to expand~     drug-free social networks.~   "
30770|NCT02654353|"~     This is a prospective randomized controlled trial that compares the conventional stepwise~     approach with a new sequential substrate ablation approach for persistent atrial~     fibrillation.~   "
30771|NCT02654340|"~     Association of specific mutations (genotype) after sequencing the TSC1 and TSC2 gene with~     the clinical manifestations (phenotype) of the tuberous sclerosis complex in a cohort of~     clinically well characterized tuberous sclerosis complex patients. The obtained samples will~     be used to establish a tandem-MS-based biomarker.~   "
30772|NCT02654327|"~     This is a trial of a new way of treating patients with respiratory failure. The~     investigators propose to deliver a multi-centre clinical trial to determine whether~     veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume~     mechanical ventilation improves outcomes and is cost-effective, in comparison with standard~     care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure~   "
30773|NCT02654314|"~     A double blind randomized controlled trial investigating melatonin, 5mg, compared to~     placebo, given to patients at least 65 years old, admitted to the hospital on a general~     medical floor, to prevent delirium.~   "
30774|NCT02654301|"~     The present study determined the effect of Xylose consumption on postprandial hyperglycemia~     in normal (n=25) and hyperglycemic subjects (n=50).~   "
30775|NCT02654288|"~     Investigators have previously found that the infiltration of immunoglobulin G4(IgG4)~     positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after~     curative resection. Investigators further attempt to explore the possible roles of IgG4 and~     the inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In~     this primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10~     in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of~     IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.~   "
30776|NCT02654275|"~     Many children and adolescents who engage in swimming complain of shoulder pain during or~     after exercise. This pain may worsen and may lead to a decline in performance as well~     avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of~     this study is to determine whether proprioceptive intervention training will effect the~     power capacity, proprioceptive ability and technique of young swimmers.~   "
30777|NCT02654262|"~     Obesity during adolescence, a critical time for bone development, may impair mineral accrual~     and reduce bone strength, leading to greater fracture risk during adolescence and later in~     life. This study seeks to determine the effect of obesity and accompanying metabolic changes~     (insulin resistance and inflammation) on bone mineral accrual and related changes in~     structure and strength in young girls. The information is critical to developing effective~     prevention strategies to counter the linked risks of obesity and osteoporosis, both major~     public health concerns.~   "
30778|NCT02654249|"~     The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing~     two different strategies in the treatment of grade III and IV hemorrhoids: transanal~     hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.~   "
30779|NCT02654236|"~     The main purpose of this study is to see whether heavy drinking will interfere with a~     specific pathway, called FXR signaling in the liver. The abnormality of this pathway may~     lead to liver injury in some patients who drink heavily.~   "
30780|NCT02654223|"~     The purpose of the study is to evaluate the more efficient dose for the treatment of~     rhinitis/rhinoconjunctivitis against grass pollen allergy~   "
30781|NCT02654210|"~     The purpose of this study is to determine in what way infections, microbiome, and~     vaccinations during childhood interact in shaping the development of immunity and tolerance.~     The investigators collect and use data from a birth cohort focusing on infectious diseases~     during childhood and apply a life course perspective.~   "
30782|NCT02654197|"~     The investigators believe that there is an association between H. pylori infection and~     nutritional status and between H. pylori infection and cognitive development. The current~     study will examine this association in Israeli children, aged 6-12 years.~   "
30783|NCT02654184|"~     The quality of induction with sevoflurane, along with its ability to generate optimal~     conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle~     relaxants, has also been well documented. An ideal inhalation induction technique besides~     being rapid and comfortable for the patient should be economical. To achieve rapidity, use~     of vital capacity breaths with 8% sevoflurane is a more popular method of induction compared~     with the conventional incremental induction.~   "
30784|NCT02654171|"~     VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to~     evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect~     of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.~   "
30785|NCT02654158|"~     Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of~     Fuganlin Oral Liquid in children with acute upper respiratory infection~   "
30807|NCT02653872|"~     This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to~     assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and~     in combination with multiple doses of verapamil and itraconazole or diltiazem~   "
30808|NCT02653859|"~     By testing the CTC number of new solitary pulmonary nodule patient, evaluating the~     correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the~     correlation of CTC number and the size of lung nodules of the malignant patients, the~     correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC~     and tumor markers will be detected before the patient received treatment. Tumor markers~     include Pro-GRP, NSE, CEA, CYFRA211, SCC.~   "
30786|NCT02654145|"~     Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and~     reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E~     (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic~     asthma. The aim of this study is to investigate whether subjects not optimally controlled on~     their current omalizumab treatment, who are eligible for therapy with mepolizumab can be~     effectively and safely switched to treatment with mepolizumab to improve asthma control. The~     study will provide data on the efficacy, safety, immunogenicity, and tolerability of~     mepolizumab when switched directly from omalizumab without any wash-out. The learnings from~     this study may help guide physicians when substituting one biologic with another for the~     treatment of patients with severe eosinophilic asthma.~      The study will be a multi-centre, open-label single arm trial. Patients with severe~     eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be~     eligible to participate. Subjects will remain on their current maintenance therapy including~     omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At~     Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to~     mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32~     weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last~     dose of mepolizumab.~   "
30787|NCT02654132|"~     The purpose of this study is to determine if adding elotuzumab to pomalidomide and low-dose~     dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma~     compared to pomalidomide and low-dose dexamethasone alone.~   "
30788|NCT02654119|"~     This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and~     trastuzumab work when given after surgery in treating patients with stage I-II human~     epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast~     or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as~     cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of~     tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel and trastuzumab after~     surgery may help prevent the cancer from coming back.~   "
30789|NCT02654106|"~     This clinical trial was designed to investigate the efficiency and toxicity of fractionated~     stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain~     metastases.~   "
30790|NCT02654093|"~     The purpose of this study is to learn about the effect of raloxifene on how the body absorbs~     and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken~     together.~   "
30791|NCT02654080|"~     The purpose of this study is to evaluate the safety and tolerability of an HIV-1~     nef/tat/vif, env pDNA vaccine delivered with electroporation (EP), followed by a recombinant~     vesicular stomatitis virus (rVSV) HIV envC vaccine boost, in healthy, HIV-uninfected adults.~   "
30792|NCT02654067|"~     Pregnant patients mallampati class scores will be examined throughout pregnancy~   "
30793|NCT02654054|"~     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in~     combination with estradiol/norethindrone acetate for the management of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
30794|NCT02654041|"~     The objective of the study is to assess the safety and efficacy of treatment with~     hypothyroxinemia adjunct to conventional therapies in GBM patients.~   "
30795|NCT02654028|"~     This prospective study aims to determine whether autotransfusion of red blood cells salvaged~     during liver resection is associated with the recurrence of hepatocellular carcinoma.~   "
30796|NCT02654015|"~     The primary aim of minimally invasive surgery (MIS) for supratentorial intracranial~     hemorrhage is to achieve an atraumatic evacuation of blood products from the brain to~     prevent the secondary injury that occurs after the initial bleed. The purpose of this Phase~     II randomized trial is to provide an initial assessment of the efficacy of MIES to improve~     outcomes in patients with supratentorial ICH. Subjects will be randomized to either medical~     management or medical management with MIS.~   "
30797|NCT02654002|"~     This study will evaluate the safety and tolerability of escalating single- and multiple-oral~     doses of GS-9674, and characterize the single- and multiple-dose pharmacokinetics (PK) of~     GS-9674. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants~     will receive either GS-9674 or GS-9674 placebo.~      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,~     blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to~     multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or~     pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily~     doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will~     consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be~     initiated in parallel with cohorts in Part A if the total dose under evaluation is at or~     below a dose already evaluated.~      This study is partially blinded (no one is blinded on Day -1).~   "
30798|NCT02653989|"~     The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with~     relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either~     stable disease or a partial remission following definitive salvage therapy.~      Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but~     considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients~     who have received ASCT following salvage chemotherapy.~   "
30799|NCT02653976|"~     This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized~     study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory~     patients with peripheral T-cell lymphoma.~   "
30819|NCT02653716|"~     To evaluate the clinical and cost-effectiveness of the New Orleans Intervention Method (NIM)~     in relation to an enhanced services as usual model, Case Management (CM), for the management~     of maltreated infants and young children entering care in the United Kingdom (UK) .~   "
30820|NCT02653703|"~     The aim of this study is to quantitatively characterize the effects of L-menthol as a~     topical counter-irritant on cutaneous pain and hyperalgesia provoked by topical application~     of the TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.~   "
30800|NCT02653963|"~     This triple-blind, stratified, randomized clinical trial includes 100 eyes of 100 patients~     aged 18 to 85 years with refractory glaucoma. Eligible subjects undergo stratified block~     randomization; eyes are first stratified to one of four subgroups: group 1:patients with~     previous failed trabeculectomy, group 2: uveitic glaucoma, group 3: neovascular glaucoma and~     group 4: other indications like aphakic glaucoma or glaucoma associated with vitreoretinal~     procedures.~      In each subgroup, eyes are randomly assigned to the study arms using random blocks:~     conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 50 eyes), Ahmed Glaucoma~     Valve (AGV) with intraoperative periplate triamcinolone injection (group B, 50 eyes).~      Patients will be followed for one year. They will undergo full ophthalmology examination at~     first day, first week, month 1, 3, 6, 9 and 12 after the surgery.~      The primary outcome measure is cumulative probability of success, defined as intraocular~     pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complications,~     additional glaucoma surgery, or loss of light perception.~      The outcomes will be compared between two arms in each subgroup.~      The number of eyes requiring medications, time to initiation of medications, and number of~     medications will be compared.~   "
30801|NCT02653950|"~     In this study the investigators aim to assess whether endoscopic septoplasty is effective at~     improving patients QOL and reducing postoperative signs and complications.~      Primary outcome: To assess the differences in overall QOL between endoscopic and traditional~     septoplasty after adjusting for pertinent confounding variables.~      Secondary outcomes:~        1. To evaluate the post-operative complication rate in patients undergoing endoscopic~          septoplasty compared to traditional.~        2. To evaluate the differences in the operation time between the two different approaches.~   "
30802|NCT02653937|"~     Abstract~      Background & Aims:~      Abdominal N line tenderness for diagnosis and shigyakusan for treatment of irritable bowel~     syndrome ( IBS ) and medically unexplained physical symptoms ( MUPS ) were studied.~      K1 is point of one quarters of distance from center of navel to right anterior superior~     iliac spine. K2 is one quarters of distance from center of navel to upside of the symphysis~     pubis. K3 is center of line from xiphoid process to navel. There are three relevant lines;~     K1-K3 line, K2-K3 line, and line of identical length to K1-K3 line originating from K2 and~     running parallel to K1-K3 line. Author collectively named these 'N line'. There was not the~     study under author's investigation that effects of shigyakusan and other medicines were~     compared. Author confirmed existence of mild IBS, for whose patients existing largely,~     various expensive examinations are spent.~      Method:~      The author put pressure on N line by deep palpitation and judged of abdominal N line~     tenderness positive or negative.~      Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS~     by Rome III, of no IBS by Rome III, and of MUPS. The change of symptoms of IBS and MUPS by~     shigyakusan was showed with an arrow by self-declaration.~      Conclusions:~      Shigyakusan was more effective for IBS than previous medicines. IBS was diagnosed by Rome~     III and N line tenderness and author confirmed the existence of mild IBS which was diagnosed~     by N line tenderness with help of RomeIII. MUPS showed N line tenderness though patients~     complained of no abdominal symptoms. Shigyakusan was very effective for IBS, mild IBS and~     MUPS.~   "
30803|NCT02653924|"~     The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound~     healing- they are responsible for flaps approximation, hemostasis and restoring function and~     esthetics.~      Choosing the right suture is crucial especially in oral sites because of its unique~     anatomical features: the presence of saliva and the patient's everyday function- swallowing,~     talking, eating etc.~      Sutures require certain physical properties such as tensile strength, dimensional stability,~     lack of memory, knot security and elasticity. One highly important quality is the ability to~     prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are~     many kinds of sutures in the market- none of which contains all the ideal features.~      The aim of the study is to compare the amount of bacterial adhesion to different kinds of~     sutures in patients undergoing periodontal surgery.~   "
30804|NCT02653911|"~     Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of~     reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular~     menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical~     manifestations of PCOS. The aim of this study is to determine whether electroacupuncture~     normalizes hormonal and glycometabolic profiles in women with polycystic ovary syndrome when~     compared with placebo-needle.~   "
30805|NCT02653898|"~     Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many~     have begun advocating for concerted malaria elimination efforts in Cambodia. However, there~     is currently no consensus on how malaria elimination is to be achieved with the tools~     available.~      In this study, the investigators will conduct operational research with the Royal Cambodian~     Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness~     of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused~     screening and treatment (FSAT) - in a head to-head comparison. In addition, the~     investigators will quantify the relative contribution of a recently advocated vector~     intervention for military personnel - the insecticide treated uniform (ITU) - in addition to~     other vector control measures currently employed by the RCAF. The investigators will employ~     the same permethrin insecticide self-application kits currently used by the US military. The~     investigators will estimate the cost effectiveness of each approach and attempt to define~     the best way forward for malaria elimination efforts in a critically important malaria~     reservoir in military population (and their dependents) who reside on the Thai-Cambodian~     border. The aim of the study is not only to conduct research to better define the best way~     forward in malaria elimination efforts in the high risk military populations, but to also~     build capacity within the RCAF to support and lead future elimination efforts in the most~     difficult-to-reach mobile populations.~   "
30806|NCT02653885|"~     The outcome predictors for cardiac surgery has been popular for many researchers and~     clinicians. Determining risk factors before surgery reduce morbidity and mortality after~     surgery. Some routine blood results have been used as predictors for cardiac surgery but~     none of the researches studied red cell distribution width, mean platelet volume,~     platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these~     parameters and to see whether these parameters can be predictors for cardiac surgery.~   "
30809|NCT02653846|"~     Portal hypertension (PH) results from the increase of portal flow resistance in fibrotic~     tissue of the liver in patients with chronic liver diseases, leading to complications such~     as varices formation and variceal bleeding, ascites formation, spleenomegaly and~     hypersplenismus, systemic haemodynamic disorders and porto-systemic shunts formation. Early~     detection of PH in patients with chronic liver diseases is clinically important as it should~     change patient management in order to prevent the formation/onset or recurrence of PH~     complications. Hepatic venous pressure gradient (HVPG) measurement is the gold standard for~     the assessment of the severity of PH. However, it is an invasive method with its risks, and~     relatively costly. On the other hand transient elastography (TE) emerged as a non-invasive,~     easy, safe and low cost method with the potential to assess the severity of PH, as liver~     stiffness (LS) and spleen stiffens (SS) measured by TE showed very good correlation with~     HVPG. Real-time 2D shear wave elastography (RT-2D-SWE) is an ultrasound elastography method~     reliable for non-invasive assessment of fibrosis stage especially in chronic viral~     hepatitis, but only preliminary data exist on the correlation of RT-2D-SWE measured LS/SS~     with and HVPG. In this study we hypothesized that LS and SS measured by RT-2D-SWE correlate~     with HVPG enabling RT-2D-SWE to be used for the assessment of severity of PH. The primary~     aim of this study is to analyse correlation between LS and SS as assessed by RT-2D-SWE and~     TE with the grade of portal hypertension as assessed by HVPG. The secondary aims are: 1) to~     analyse clinical outcomes of these patients in order to determine if LS and/or SS as~     assessed by RT-2D-SWE might predict adverse outcomes (liver decompensation, death or HCC~     development), and 2) to compare clinical performance (AUC) of RT-2D-SWE and TE for the~     assessment of the PH severity as well as for predicting clinical outcomes. Patients with~     suspicion of having compensated advanced chronic liver disease (cACLD) as assesed by~     non-invasive methods (transabdominal ultrasound, laboratory findings, FIB-4 and APRI score,~     and LS measurements by TE), will be included. Since positive predictive value of~     non-invasive methods for cirrhosis is generally not very reliable, these patients will be~     offered transjugular liver biopsy and HVPG measurements as gold-standard methods to define~     the stage of liver disease and severity of PH. These patients will undergo LS and SS~     measurements by RT-2D-SWE on Aixplorer SuperSonic Imagine ultrasound system and HVPG~     measurements as well, with transjugular liver biopsy performed during the same session.~     After SWE™ and HVPG measurement, 5-year follow-up is planned, including standard~     surveillance: laboratory findings, transabdominal US every six months and upper-GI endoscopy~     according to relevant guidelines, as well as treatment according to relevant guidelines as~     indicated: beta blockers, endoscopic variceal ligation, etiologic treatment and dietary~     measures. Appropriate statistical analysis will be undertaken after the enrollment period,~     as well as after follow-up period.~   "
30810|NCT02653833|"~     This pilot study tests the hypothesis that the medication Ranolazine improves blood flow to~     the skeletal muscle during exercise. The investigators will use cutting edge technology with~     contrast enhanced ultrasound to visualize the microvascular blood supply to the forearm.~     Animal studies have shown reversal of muscle damage with improved delivery of blood to the~     exercising muscle. This research aims to understand the mechanism of action of this~     medication in a way it has never been studied before. The results may help benefit~     individuals with muscular Dystrophy in the future.~   "
30811|NCT02653820|"~     Reflexology treatment may influence the severity of chemotherapy-induced nausea and~     vomiting. This study aims to investigate the clinical effect of reflexology on~     chemotherapy-induced nausea and vomiting.~   "
30812|NCT02653807|"~     Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which~     can impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the~     efficacy of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for~     improving ankle dorsiflexion range of motion (ROM) and musculoarticular stiffness (MAS).~   "
30813|NCT02653794|"~     It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life~     for macular region to develop from structural formation to functional integrity. However,~     children are still in the critical period of plastic visual development, for their visual~     acuity has not yet reached the level of adults. Similarly macular retinal structure may~     develop with age. It is very important to study in macular thickness of this period and to~     have a proper cognition of it and the relation between macular thickness and other ocular~     parameter for the research of retinal development and diseases and the early screen of~     fundus diseases.~   "
30814|NCT02653781|"~     Realistic simulation is an effective teaching strategy for the acquisition and retention of~     knowledge and increased self-confidence of students, which contribute to safety in~     performing nursing actions.Considering the need to adopt safe practices in health since~     professional training, there are deficiencies in health teaching and weaknesses in the~     acquisition of practical skills guided by safety principles and critical clinical reasoning.~     The purpose is to compare the use of high fidelity simulation with traditional education as~     innovative method in the process of teaching and learning. This is a prospective,~     randomized, controlled and single-blind study, of pre-test and post-test experimental type,~     with application of high fidelity simulation in the theme of patient safety in~     administration of parenteral drugs.~   "
30815|NCT02653768|"~     Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of~     disability among Veterans. Although exercise is known to improve pain, physical abilities,~     and other outcomes for patients who have knee OA, most individuals with this condition are~     physically inactive. Therefore there is a need to develop programs that will help Veterans~     and others with knee OA to increase activity levels. This study will examine a stepped~     approach to helping Veterans with knee OA to increase physical activity, with increasing~     levels of program intensity when needed for individual patients to meaningfully improve pain~     and physical function.~   "
30816|NCT02653755|"~     This research study is a way of gaining new knowledge about whether patients can omit~     radiation treatment after undergoing a lumpectomy, also known as breast conserving~     surgery. In this trial, we are attempting to identify which patients may not need~     radiation.~   "
30817|NCT02653742|"~     The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with~     fentanyl intranasal used in our hospital for pain control in children undergoing bilateral~     myringotomy with placement of pressure equalization tubes (BMTs).~   "
30818|NCT02653729|"~     This study aims to examine the effectiveness of cognitive behavior therapy for psychosis in~     first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive~     behavior therapy mostly use in depressive patient to treat the negative thinking pattern~     Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in~     recent years for a number of reasons. Evidence has been available for the past two or three~     decades regarding the success of these techniques with other forms of psychopathology such~     as depression, anxiety disorders, and medical problems. Anxiety, depression and low~     self-esteem have been cited as the most common consequences of psychotic disorders. The~     observation has also emerged that many patients develop their own coping strategies for~     reducing the frequency, severity, and disruptiveness of their symptoms. There has also been~     increasing evidence regarding the influence of social environmental factors on the course of~     psychosis and the development of stress-vulnerability models to explain these relationships.~     Research suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics~     continue to experience difficulties related to their psychotic symptoms.~   "
30822|NCT02653664|"~     Chronic pain is a significant problem for many Veterans, including new Veterans returning~     from Iraq and Afghanistan. It is also associated with a number of other significant~     problems, such as post-traumatic stress disorder and sleep problems. All of these can have~     significant negative effects of the quality of life of Veterans~      Three different types of treatment that have been used to treat chronic pain in the general~     population include self-hypnosis, education about chronic pain, and teaching individuals how~     to be more mindful. The purpose of this study is to see if these three treatments can help~     decrease pain in Veterans. Additionally, the researchers want to determine if each of these~     treatments can help reduce the negative consequences associated with pain, such as changes~     in mood, sleep, and enjoyment of life.~      Different types of treatment that include self-hypnosis, education about chronic pain, and~     learning skills on how to change how a person perceives his/her pain have been used to treat~     chronic pain the general population.~      The purpose of this study of this study is to see if these different treatments can help~     decrease pain and improve quality of life in Veterans with chronic pain, and determine how~     and why these treatments are effective. A subject must have a Veteran status, have chronic~     pain, speak English and be at least 18 years old to participate.~   "
30823|NCT02653651|"~     Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain~     after surgery remains a significant clinical problem as it impairs recovery adversely and~     may lead to the transition to chronic pain. The open approach represents a major physical~     trauma including postoperative pain and discomfort in the convalescence period. Adequate~     control of postoperative pain facilitates earlier mobilization and rehabilitation.~     Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be~     inadequate for dynamic analgesia and may also elicit side effects that may delay hospital~     discharge. Preventing early and late postsurgical pain is an important challenge for~     anesthesiologists and surgeons.~      Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker)~     are popular analgesic adjuvants for improving perioperative pain management. The~     investigators designed this double-blind, placebo controlled study to test and compare the~     preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic~     pain after elective open nephrectomy.~      The investigators propose a double-blind placebo-controlled study of patients undergoing~     elective open nephrectomy. All patients will receive normal patient-controlled analgesia~     morphine in addition to study drugs or placebo. Research will be conducted at Charles~     Nicolle teaching hospital.~   "
30824|NCT02653638|"~     Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy~     sedentary older adults, and healthy exercise trained older adults. This variable will be~     examined before and after administering the cyclooxygenase inhibitor indomethacin, which has~     been shown to blunt cerebral vasodilator responses. In addition, the investigators will~     examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by~     indomethacin.~   "
30825|NCT02653625|"~     This is a single-arm, open label, proof of concept (PoC) study of Cenicriviroc (CVC) in~     adult subjects with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC~     study is to assess changes in alkaline phosphatase (ALP) both individually and as a group,~     over 24 weeks of treatment with CVC.~   "
30826|NCT02653612|"~     The goal is to improve surgery by preventing tumor cells from being left behind at the time~     of surgery. This includes finding residual tumor cells in the wound after surgery.~   "
30827|NCT02653599|"~     This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group,~     Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to~     evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight~     following administration for 3 months.~   "
30828|NCT02653586|"~     The study was a group randomized controlled trial. Within each school Classes of high school~     students were allocated by randomization to the intervention or control group by a function~     Randomization in Excel program. Outcomes were measured by questionnaire at pre-~     intervention, post-intervention and 3-month follow-up. The study protocol was approved by~     Tel Hai college institutional review board. Parents of all participants, in the intervention~     and in the control group, received information about the program and the study and were~     choose whether to provided informed consent or not.~   "
30829|NCT02653573|"~     This study was designed to evaluate the feasibility of a telephone-based health coach~     self-management intervention for young adults.~   "
30830|NCT02653560|"~     In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits,~     vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in~     controlling hypertension. Key components of such a diet are potassium, magnesium and alkali,~     each of which has been implicated in lowering blood pressure. Whether a liquid formulation~     of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is~     unknown.~   "
30831|NCT02653547|"~     Patients receive two weeks of treatment (prefrontal high-frequency and bilateral~     low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After~     two weeks of treatment they can decide if they want to quit the treatment or if they want to~     proceed with the treatment for another two weeks.~   "
30832|NCT02653534|"~     This study is being conducted to assess the impact of promoting community initiated Kangaroo~     Mother Care (KMC) for low birth weight babies on post enrolment neonatal mortality and~     mortality post enrolment upto 6 months of age. This large individually randomized controlled~     trial will enroll 10500 low birth weight babies. The secondary objectives are examining the~     impact of the intervention on exclusive breast feeding and growth at 1 and 3 months,~     infections and hospitalizations in the neonatal period and from 1 to 5 months of age,~     recognition of illnesses and early care seeking from appropriate sources, motor and mental~     development in a subsample.~      Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of~     birth. Eligible babies are randomized to intervention or control arms. Mothers in the~     intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse~     Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home~     visits are conducted in both intervention and control arms by government workers according~     to the existing government program.~      Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.~   "
30834|NCT02653508|"~     The Feeding-Exercise Trial in Adolescents (FETA) was a randomised controlled intervention~     study designed to promote healthy weight in overweigh and obese adolescents through a~     professional-delivered, community-based program with active parents' involvement, focused on~     supervised physical activity and structured nutritional education. The aim of FETA was to~     test the efficacy of two intervention groups- physical activity in isolation and combination~     of physical activity with provision of dietary information- for improving overweight and~     obesity in adolescents. Our primary hypothesis was that a combined program would be more~     efficacious than activity in isolation and that activity alone would also be effective~     compared to control group in improving adiposity profiles in overweight and obese~     adolescents as well as family activity and feeding habits.~   "
30835|NCT02653495|"~     Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that~     predispose individuals to coronary heart diseases and diabetes but obesity has been shown to~     increase the risks of other diseases like cancer and asthma. Studies have also shown that~     obesity increases the risk of severe influenza infection and associated death and reduces~     the efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms~     have not been described. The investigators are thus hypothesizing that differences in the~     innate immune responses between individual with or without metabolic syndrome impact viral~     infection and vaccine outcome. The investigators will perform seasonal influenza vaccination~     in people with or without metabolic syndrome to determine if the late adaptive response~     assessed by antibodies titers is different between the two groups and correlates with the~     early immune response assessed by gene expression profile in whole blood cells. The project~     proposed by the investigators will contribute to a better understanding of the inflammatory~     phenotype associated with metabolic syndrome and establish for the first time if it affects~     the immune protection against infectious diseases and particularly against influenza virus~     infection. The results will be important to determine if the population affected by~     metabolic syndrome should receive anti-influenza treatment in priority in the context of a~     severe influenza epidemic.~   "
30836|NCT02653482|"~     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared~     with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and~     quality of life in patients with type 2 diabetes and chronic heart failure with reduced~     systolic function.~   "
30837|NCT02653469|"~     Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator~     based on heart-lung interaction to predict fluid responsiveness. Generally, patients are~     considered to be fluid-responsive when the PPV value larger than 11-13%. However, several~     previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To~     predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%),~     the investigators would evaluate the augmented PPV using augmented ventilation.~   "
30838|NCT02653443|"~     The objective of this study is to test the hypothesis that INTERCEPT Blood System for~     platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain~     sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of~     autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test~     platelets) stored for 6 or 7 days will be measured in comparison to fresh autologous~     radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing~     (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will~     also be assessed.~   "
30839|NCT02653430|"~     This is a long-term follow-up and interventional study in individuals who have been~     diagnosed with moderate to severe obesity with or without diabetes. The purpose of this~     study is to determine the effects of sleeve gastrectomy on weight and blood sugar control~     and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance~     imaging (fMRI) ,adipose tissue expression chip and etc.~   "
30840|NCT02653417|"~     The purpose of this study is to determine the clinical safety of and whether RAD1901 reduces~     the frequency and severity of VMS in postmenopausal women regardless of uterine status.~   "
30841|NCT02653404|"~     The aim of this project is to analyze the potential contribution of IGRA test QuantiFERON-TB~     Gold In Tube test (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in the~     diagnosis of tuberculosis (TB - active or latent) in pediatric subjects (0 and 17 year)s~     recently exposed to infection (indicated as contacts) or with clinical suspicion of active~     TB, and to compare the results obtained with those of the TuberculinSkin Test (TST; gold~     standard). The project is expected to enroll up to 50 pediatric patients over a 4-year~     study. Children with access to Ambulatory structures or hospitalized at University~     Infectious Diseases Clinic or Pediatric Clinic, University Hospital of Siena, or with access~     to Ambulatory or hospitalized at Pediatric Clinic USL 9 Grosseto will be enrolled. Once~     obtained the informed consent of patients' parents or legal guardians, patients will be~     enrolled. The doctor will administer a clinical-anamnestic questionnaire, relative to the~     country of birth and residence, date of arrival in Italy and any stays in the country of~     origin (in case of foreign patient), travels abroad, risk factors for infectious diseases,~     type of contact with any index case, previous vaccination with BCG, date and outcome of the~     TST, clinical symptoms and signs suggestive of active TB, report of any instrumental~     investigation. Together with the collection of blood samples for routine purposes, an~     additional blood sample will be taken so to run IGRA test. Also patients for whom their~     medical doctor will independently order to run QTF-GIT test as necessary tool for the~     clinical diagnosis of TB will be included in the study.~      A retrospective analysis will be performed on patient pertaining to participant Clinics,~     from 1 January 2012 to 31 May 2015. Such analysis will be performed on those patients for~     which their medical doctor requested both intradermal Mantoux and IGRA test.~      Expected results:~        -  estimation of concordance between QuantiFERON-TB Gold In Tube and TST in pediatric~          patients exposed to TB, with or without latent TB infection~        -  Evaluation of the sensitivity of the test QTF-GIT in patients with active tuberculosis~          disease~        -  Evaluation of specificity of testQTF-GIT in not infected patients~        -  Evaluation on the possible use of QTF-GIT, together with TST, to improve the diagnosis~          of tuberculosis latent or active infection in pediatric subjects.~        -  Evaluation of the possible diagnostic use of QTF-GIT in the child <5 years.~   "
30842|NCT02653391|"~     This is a Phase 1/2, prospective, randomized, double-masked, vehicle controlled, paired-eye~     study in approximately 16 subjects to evaluate safety, tolerability and efficacy of~     elamipretide 1.0% topical ophthalmic solution in patients with FCED presenting with mild to~     moderate corneal edema.~   "
30843|NCT02653378|"~     The purpose of this study is to determine how the modality of energy depletion can~     differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.~   "
30844|NCT02653365|"~     The aims of our study was to identify early predictors of non-invasive ventilation failure,~     so as to alert clinicians early that endotracheal intubation and mechanical ventilation~     might be appropriate.~   "
30845|NCT02653352|"~     The purpose of this study was to encourage students to reduce soft drinks intake,~     substituting it by water, in order to prevent and control overweight prevalence.~   "
30846|NCT02653339|"~     This is a controlled clinical trials about traditional Chinese medicine named Qufeng~     Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix~     sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on~     treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from~     Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result~     of the self and between-group cross-reference by two questionnaires filled before and after~     treatment.~   "
30847|NCT02653326|"~     In this randomised, double-blind, pilot study, the investigators aim to assess whether a~     telerehabilitation strategy could improve outcomes among patients with recent heart surgery.~     Included participants will receive a comprehensive rehabilitation programme comprised of~     physical therapy, nutritional counselling, psychological assistance in addition to standard~     medical care. After 12 sessions of physical therapy, patients will be randomised to receive~     telerehabilitation with a portable EKG device and a smartphone application or usual care.~     The primary endpoint for this study is the exercise capacity of included participants, which~     will be assessed using an ergospirometer at 4 and 8 weeks after randomisation.~   "
30848|NCT02653313|"~     Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects~     suffering from metastatic, inoperable pancreatic cancer with at least one hepatic~     metastasis.~   "
30849|NCT02653300|"~     This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with~     NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo~     run-in, treatment phase and end-of-study phase.~   "
30850|NCT02653287|"~     Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will~     be approached to enroll in a one year clinical trial looking at decreasing fatigue in~     persons with systemic lupus erythematosus (SLE). The intervention group will receive~     individual coaching and group educational sessions focusing on physical activity and~     nutrition while the control group will receive individual calls in relation to SLE~     self-management group educational sessions.This study is designed to evaluate the LIFT~     intervention to decrease fatigue (primary outcome), improve physical activity (secondary~     outcome) and dietary behavior (exploratory outcome) in persons with SLE.~   "
30851|NCT02653274|"~     Breakfast porridges are made from milled grains and are commonly eaten worldwide.~     Traditionally different grains are used in different countries. For example, oats are more~     common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst~     millet is very common in parts of India and Africa. However the nutritional value and~     potential metabolic and health effects may vary dramatically between different grains. For~     example what is the effect of the different grains on blood sugar or on how fast the stomach~     empties after eating the porridge and how full people feel. All these physiological~     responses may differ between these grains resulting in potential health benefits.~      RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains~     will behave differently during the digestion and cause differences in blood glucose levels,~     gastric emptying and appetite.~      This study, which is a 4-way, randomized, cross over pilot study in healthy participants,~     aims to answer this research question.~      The participants will be asked to eat a porridge breakfasts made with oats, rye and millet~     of different varieties (but containing the same amount of calories), in 4 morning studies~     one week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and~     measure gastric emptying using MRI, blood glucose levels using a finger prick test and~     self-reported appetite scores.~   "
30852|NCT02653261|"~     Transurethral resection of the prostate (TURP) represents the gold standard in the operative~     management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder~     tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most~     important complications of urological endoscopic resections is intraoperative and~     postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free~     of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury,~     fluid overload, increased costs and hospital length of stay.~      Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis~     by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has~     been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac~     surgery and orthopedic surgical procedures but few studies have assessed the efficacy of~     this antifibrinolytic agent in urological endoscopic procedures.~      The investigators designed this double-blind, placebo controlled study evaluate the safety~     and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in~     patients undergoing endoscopic surgery in urology.~   "
30853|NCT02653248|"~     Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can~     target the tumor more precisely and cause less damage to normal tissue. This is a Phase I~     research study looking at the safety of the dose of SBRT in organ confined prostate cancer.~   "
30854|NCT02653235|"~     Acquiring, processing and utilising information is crucial to any mental function~     -including seemingly simple daily functions. Collectively called 'cognitive functions',~     these processes are a result of different regions of the brain acting together.~      Disruption of these cognitive functions increases the risk of development of mental health~     problem. Recently it has been proposed that inflammatory pathways may contribute to~     disorders of cognition and behaviour like depression.~      This is largely due to research showing that those with inflammatory conditions like~     arthritis are more likely to develop mental health problems like depression. Conversely,~     those who suffer from mental health problems (even in the absence of inflammatory~     conditions) have large amounts of inflammatory molecules in the blood. Studies in animals~     suggest that inflammation outside the brain can reach and affect the brain in a number of~     ways. So, does inflammation play a role in the development of cognitive and behavioural~     symptoms? What are the pathways involved?~      The current project tries to address this question. Specifically, the investigators intend~     to use modern scanning techniques to examine the effect of inducing a low grade inflammation~     (using a commonly used typhoid vaccine) to see how the inflammation affects how different~     regions of the act together to perform cognitive functions.~   "
31197|NCT02648750|"~     This feasibility study evaluates whether it is possible to run a larger scale study to~     investigate the use of a self-management programme with adults who have recently had a~     stroke. Half of the participants will receive support with self-management from stroke~     therapists, while the other half will receive it from rehabilitation assistants.~   "
30855|NCT02653222|"~     In this study the investigators are going to assess the feasibility of this innovate~     technique of renal sympathetic denervation by translumbar access under ct-guidance.~      To limit the potential impact on the kidney, the investigators chose a population of chronic~     renal failure patients on dialysis or renal transplant (with native kidneys still present)~     and having resistant treatment hypertension despite antihypertensive combination therapy~     well conducted.~      The investigators expect to obtain a decrease of the blood pressure at the 24-hours~     ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.~   "
30856|NCT02653209|"~     The aim of this project is to identify subgroups of patients with type 2 diabetes that~     respond well or poorly to particular drugs based on particular clinical characteristics such~     as their weight or kidney function, to enable better targeting of treatment for a particular~     individual.~      This study will test 2 hypotheses of drug response supported by routine clinical and trial~     data. 600 patients with type 2 diabetes who have suboptimal glycaemic control on dual oral~     therapy will be recruited to a randomised double-blind crossover study of a DPP4 inhibitor,~     SGLT2 inhibitor and thiazolidinedione. Each patient will take each study drug in addition to~     their existing treatment for four months at a time. At the end of each treatment the~     patient's glucose control will be measured and information about their experience of the~     drug will be collected.~   "
30857|NCT02653196|"~     There is currently no standard treatment for patients with neuro-epithelial (brain) or other~     solid tumors in another part of the body who do not have adequate suitable autologous~     hematopoietic progenitor cells available and/or whose disease has relapsed after standard~     treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for~     treatment of patients with recurrent chemo-responsive malignant (high grade)~     neuro-epithelial and other solid tumors or those who do not have suitable autologous~     hematopoietic progenitor cell availability. The procedure in which your own blood stem cells~     are transplanted to you is called an autologous (from your own) progenitor cell transplant~     and when cells from a matched donor are transfused is called an allogeneic progenitor cell~     transplant. The study is being conducted to evaluate the safety and effectiveness of a~     combination of drugs followed by an allogeneic hematopoietic progenitor cell transplant~     (HPCT). This treatment regimen is experimental in that although the individual drugs are~     commonly used to treat your disease, the specific combination used in this protocol followed~     by the transplant is experimental.~   "
30858|NCT02653183|"~     The primary objective of this investigation is to evaluate if complications related to~     surgical wound are more common in the treatment group compared to the control group starting~     from operation day until last visit.~      The secondary objectives are to evaluate:~        -  the performance of the dressing~        -  the comfort, conformability and the acceptability of the dressing~        -  pain before and during dressing removal on the last visit~   "
30859|NCT02653170|"~     The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial~     that aims to improve the experience of stroke patients after they return home. The MISTT~     study will test the effect of two complementary interventions against usual care. The two~     interventions include: a) Stroke Care Managers (SCMs) who are trained social workers, and b)~     an online informational website or portal. The 12 week intervention period begins when the~     stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at~     least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with~     weekly follow-up telephone calls. Supplemental home visits will be used as necessary over~     the 12 week period. At the first home visit the social workers will conduct a comprehensive~     in-home assessment and link patients and caregivers to local resources as necessary.~     Patients also assigned to the website will have access to a patient-centered online~     information and support resource called the Virtual Stroke Support Portal (VSSP). The~     investigators hypothesize that this personalized case management program will reduce patient~     and caregiver needs, improve quality of life, and decrease caregiver stress. The MISTT study~     will enroll 480 acute stroke patients discharged from 4 Michigan hospitals and will be~     completed by the end of 2017.~   "
30860|NCT02653157|"~     This is a prospective observational study to determine the role of colonization and identify~     the timing of development of drug resistance in multidrug resistant Gram-negative bacilli~     (MDR-GNB) causing infection among critically ill burn patients.~   "
30861|NCT02653144|"~     The purpose of the study is to determine if perineural dexmedetomidine can provide increased~     prolongation of analgesia when compared to perineural dexamethasone in patients receiving~     regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct~     to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.~   "
30862|NCT02653131|"~     The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like~     peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of~     the intestine.~   "
30863|NCT02653118|"~     Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to~     evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in~     preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types~     16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from~     the Nordic countries, and the highly efficient screening and surveillance system there,~     study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and~     Sweden. The hypothesis being tested is that V503 vaccine will remain effective for at least~     14 years after the start of vaccination.~   "
30864|NCT02653105|"~     Does the olfactomédine provide an help to limit the number of false positives in the overall~     imaging balance and limit the number of unnecessary biopsies?~   "
30865|NCT02653092|"~     Obesity plays an adverse role at every stage of conception and pregnancy and mounting~     evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle~     hormone secretion as likely contributors to the subfertility phenotype and possible~     contributors to complications of pregnancy and the developmental origin of adult diseases~     such as diabetes and cardiovascular disease. This study will be the first comprehensive~     investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and~     inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic~     hypogonadotropism and its potential adverse reproductive outcomes. The investigators~     findings will be used to inform a subsequent clinical intervention to optimize reproductive~     outcomes for obese women and their offspring.~   "
30866|NCT02653079|"~     Patients suffering from chronic degenerating diseases are often treated by a plethora of~     NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many~     patients are refractory to this treatment and suffer from chronic pain over years, leading~     to a worsening of the quality of live. The mobilization of these patients is one main goal~     in the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT)~     is applied since more than one century for the local treatment of chronic degenerating joint~     diseases. The success of the treatment was described by many retrospective as well as~     pattern of care studies, respectively.~      Local (only at the painful joint) low dose irradiation of the chronic patients results in~     most patients in a significantly reduced pain, not only direct after the therapy, but also~     lasting for more than 12 month in many cases. The patients experience enhanced mobility and~     increased quality of life. The molecular and cellular processes leading to the pain~     reduction are just fragmentarily analyzed. Our group revealed that macrophages are key~     players in radiation-induced immune modulation. Inflammatory macrophages exposed to low~     doses of radiation showed a reduced inflammatory capacity and attenuated an inflammatory~     microenvironment. Besides macrophages further immune cells are most likely involved in~     reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.~      The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of~     patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT~     in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining~     over 30 immune cell subsets and additionally their activation status. Further, biodosimetry~     will be performed with the whole-blood samples to get hints about dose that the immune cells~     are exposed to. This will be performed with national and international co-operation~     partners.~      The IMMO-LDRT01 study is a prospective and observational study not influencing the standard~     therapeutic scheme and will provide hints how the LDRT affects besides local cells in the~     irradiated area also the systemic inflammatory response.~   "
30867|NCT02653066|"~     The purpose of this research is to study the utility of using the HealtheRx as a tool to~     recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the~     University of Chicago. HealtheRx is an example of a potential recruitment tool that has high~     reach in populations typically underrepresented in research studies, uses a high tech~     infrastructure that allows matching of research opportunities to patient characteristics,~     but that delivers information in a low-tech, patient-centered mode using the printed~     HealtheRx prescription.~   "
30868|NCT02653040|"~     The purpose of this pilot study is to evaluate wether a naturalistic indoor light~     environment can improve sleep and mood in psychiatric inpatients~   "
30869|NCT02653027|"~     The purpose of this research study is to find out if the combined therapy~     lumacaftor-ivacaftor effects how people with cystic fibrosis respond to an oral glucose~     tolerance test, a test for diabetes.~   "
30870|NCT02653014|"~     This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to~     moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of~     KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma~     aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to~     support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III~     study.~   "
30871|NCT02653001|"~     The aim of this project is to establish a list of volunteers willing and able to donate~     stool samples for use in the model colon so as to facilitate research directed toward~     understanding the basic science underlying the interactions between the gut microbiome,~     potential external modifiers, and health.~   "
30872|NCT02652988|"~     In this phase II, randomized, double-blind clinical trial, the investigators intended to~     evaluate the home-based effect of transcranial direct current stimulation (tDCS) in patients~     with fibromyalgia. This syndrome affects between 3-5% of the population in an age group~     40-60 years also occurring in childhood and old age. Reaches 3.4% of women and 0.5% of men.~     Fibromyalgia is a chronic widespread pain syndrome in various parts of the body. The~     neuromodulation techniques have as a principle produce inhibition or cortical arousal. The~     tDCS is a non-invasive brain stimulation method used to modulate the cortical excitability,~     using a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode~     electrodes. The current reaches the cortex, producing hyperpolarization or depolarization of~     the axonal membrane potential. Evidence has shown that this method is presented as a~     technique able to alter cortical and subcortical neural networks. This technique has been~     used to treat psychiatric disorders such as depression, acute mania, bipolar affective~     disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal,~     rehabilitation after stroke, pain syndromes such as neuropathic pain, migraine, pancreatitis~     pain chronic and fibromyalgia. The tDCS is a low cost technique, with virtually no side~     effects and which exerts therapeutic effect by neuromodulatory pathways by distinct pathways~     activated by the drugs. In this scenario falls within the importance of developing this~     device for home use by fibromyalgia patients, since it is easy to use and thereby enables~     maintaining the benefit observed in studies performed and supervised frequently used in care~     centers. The use of tDCS over the long term is not feasible in hospital by patients demands,~     sometimes every day or more than once a week, removing the patient from their activities,~     and cost shifting and overload the healthcare system. Therefore, the objective of this study~     is to evaluate the effect of home-based tDCS in fibromyalgia patients in long-term~     treatment.~   "
30873|NCT02652975|"~     Several cytotoxic regimens are related to endothelial cell damage and vascular toxicity.~     Endothelial dysfunction is implicated in the pathogenesis of all known cardiovascular~     diseases (CVD) and closely related to the metabolic syndrome. Both CVD and diabetes~     contributes importantly to total mortality and to breast cancer (BC) specific mortality.~      In the epidemiological part of the project, the investigators will determine the prevalence~     and incidence of cardiovascular and metabolic morbidity/mortality in early BC patients~     compared to the Danish background population.~      In the clinical part, the investigators will study the changes of endothelial function and~     metabolic parameters in BC patients receiving chemotherapy.~      With increasing number of BC survivors, long-term consequences of curative cancer treatment~     should be studied. The investigators hypothesize that cytotoxic therapy worsens metabolic~     parameters possibly through endothelial dysfunction. If this is true, the next step will be~     to evaluate how strict metabolic control will affect prognosis.~   "
30874|NCT02652962|"~     The purpose of this study is to determine the safety and tolerability of Gelesis200.~   "
30875|NCT02652949|"~     The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and~     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending~     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.~   "
30876|NCT02652936|"~     This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study~     in healthy male subjects.~   "
30877|NCT02652923|"~     This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis~     scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.~      Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy~     female volunteers to determine the optimal dose as well as the safety and tolerability of~     the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human~     lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to~     that of isotope mapping during surgery on 90 female, breast cancer patients.~   "
31210|NCT02648581|"~     The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in~     subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients~     with active posterior uveitis or panuveitis (STELABEC-2)~   "
30878|NCT02652910|"~     The goal of this clinical trial is to study how approaches for manufacturing chimeric~     antigen receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and~     therapeutic efficacy against B lymphoma. Recently, cancer immunotherapy, treatments aiming~     to arm patients with immunity specifically against cancer cells, has emerged as a promising~     therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials~     utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs~     combine the variable region of an antibody with T-cell signaling moieties to confer T-cell~     activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted~     so they are not vulnerable to MHC down regulation by tumors. However, defined by the~     activation and contraction program of their mother cells, the persistency and function of~     CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies~     largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which~     preferentially generate CAR-T cells with characteristics of terminally differentiated~     effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7~     and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T~     Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical~     animal models. This clinical investigation is to test a hypothesis whether~     IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after~     infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma~     efficacy.~   "
30879|NCT02652897|"~     Prospective, observational study aimed to investigate the specific hemostatic alterations in~     patients undergoing glial tumor resection.~   "
30880|NCT02652884|"~     The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in~     diagnosed cases brings about an increase in the number of surgeries performed on the thyroid~     gland, especially total thyroidectomy (TT), given that at present is still the gold standard~     of treatment.~      Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications,~     with an incidence of between 10 and 46% according to different sources. HPT involves longer~     hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D~     (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of~     the health system.~      While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti~     emetic of corticosteroids in thyroid surgery, the literature available to date is discordant~     in the use of steroid and its interaction with the HPT making clear the need for randomized~     clinical trials specific to analyze these variables more accurately.~      As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of~     HPT component, investigators decided t conduct a prospective randomized, triple-blind, in~     order to assess the potential benefits of the most common postoperative complication~     reported in TT.~      Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids~     deposit immediately postintubation in preventing the development of transient~     hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.~   "
30881|NCT02652871|"~     The goal of this clinical research study is to learn about the safety of LY2510924 in~     combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We~     will also study if LY2510924 in combination with cytarabine and idarubicin can help to~     control relapsed or refractory AML.~      LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream,~     where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).~   "
30882|NCT02652858|"~     Central and peripheral arterial pressure decoupling occurs in some clinical conditions like~     sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as~     the use of catecholamines.~      The aim of this study is to evaluate the pulse wave's speed as a marker of central and~     peripheral arterial pressure decoupling in a scheduled condition which is the~     cardiopulmonary bypass during cardiac surgery.~   "
30883|NCT02652845|"~     This study tests the feasibility of a health and wellness trial designed with community~     input. This 12-week program will be tested over a 24-week period using a delayed treatment~     control group.~   "
30884|NCT02652832|"~     The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS~     - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation -~     tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived~     Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood~     samples will be collected in each participants, one before the NIBS sessions, and 3 after~     the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a~     second one week after and a last one month after. Two blood samples separated by one month~     will also be collected in a a group of healthy volunteers.~   "
30885|NCT02652819|"~     This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment~     of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.~   "
30886|NCT02652806|"~     This is a randomized, multicenter, open-label, active-controlled study of the treatment of~     anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.~   "
30887|NCT02652793|"~     A 48-week, open label, non comparative prospective trial in stable chronic human~     immunodeficiency virus-infected patients having achieved complete virological suppression~     for more than 24 weeks (human immunodeficiency virus-1 RNA <50 c/ml) switching from an~     antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted~     protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at~     screening, baseline, weeks 4, 12, 24, and 48.~   "
30888|NCT02652780|"~     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in~     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial~     mutation when vision loss is present for more than six months and up to one year.~   "
30889|NCT02652767|"~     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in~     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial~     mutation when vision loss is present for six months or less.~   "
30890|NCT02652754|"~     The purpose of this study is to determine the systemic exposure of Granexin® gel after~     topical application to human subjects' diabetic foot ulcers.~   "
33887|NCT02613507|"~     The purpose of this study is to determine whether Nivolumab improves life expectancy~     compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who~     have failed prior platinum-based doublet chemotherapy.~   "
30891|NCT02652741|"~     Paediatric clinical trial in 50 children, from newborn to less than 6 years of age,~     suffering from heart failure due to congenital heart disease, to obtain paediatric~     pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat~     while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to~     describe the dose exposure in this patient population.~   "
30892|NCT02652728|"~     Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age,~     suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric~     pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat~     while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to~     describe the dose exposure in this patient population.~   "
30893|NCT02652715|"~     This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning~     disease (recurrence) in patients with non-Hodgkin lymphoma. Functional foods, such as Salvia~     hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and~     promoting optimal health. Salvia hispanica seed contains essential poly-unsaturated fatty~     acids, including omega 3 alpha linoleic acid and omega 6 linoleic acid; it also contains~     high levels of antioxidants and dietary soluble fiber. Salvia hispanica seed may raise~     omega-3 levels in the blood and/or change the bacterial populations that live in the~     digestive system and reduce the risk of disease recurrence in patients with non-Hodgkin~     lymphoma.~   "
30894|NCT02652702|"~     Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon.~     There are significant variations in the outcome of surgery due to differences in the suture~     techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and~     efficient colostomy than the conventional methods.But all those reports are single center~     retrospective cohort study，no randomized controlled trials have been carried out so far.The~     aim of this study is to comparing the safety and efficiency of circular stapler-assisted~     colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.~   "
30895|NCT02652689|"~     The LDS may contain information of significant diagnostic and physiological value regarding~     the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general.~     In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well~     as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions~     were identified. We believe that these newly discovered ultrasound signals might provide a~     non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.~      The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler~     signals performed via transthoracic parametric Doppler. The objective of the study is to~     evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to~     determine the potential assessment value of this non-invasive method in this potentially~     life threatening condition.~   "
30896|NCT02652676|"~     The purpose of this study is to: 1) Remodel and restore left ventricular geometry and~     function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac~     transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and~     reported in The Journal of Heart and Lung Transplantation in May 2013.~   "
30897|NCT02652663|"~     Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the~     evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for~     detection of colorectal liver metastases, especially for lesions which are smaller than 1~     cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid,~     gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver~     lesion including CRLM. However, compared to conventional MRI with extracellular contrast~     agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more~     expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain~     hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection.~     The purpose of this study was to compare the clinical outcome and diagnostic performance of~     Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal~     cancer.~   "
30898|NCT02652650|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in~     healthy female participants.~   "
30899|NCT02652637|"~     Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery~     postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before~     colorectal surgery. However, several recent retrospective register studies have suggested~     that mechanical bowel preparation combined to oral antibiotics before colectomy reduces~     complications compared to no preparation at all. This trial compares these two strategies to~     find out whether complications can indeed be reduced by mechanically preparing the bowel~     with oral antibiotics.~   "
30900|NCT02652624|"~     This study will evaluate the efficacy of switching to a fixed-dose combination (FDC) of~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen~     consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF),~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or~     atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)~     in virologically suppressed HIV-1 infected women.~   "
30901|NCT02652611|"~     Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can~     have a major affect on a patient's quality of life. Persistent pain after radiographic~     evidence of fracture union commonly leads to implant removal. But, the routine removal of~     orthopaedic fixation devices after fracture healing remains an issue of debate.~   "
30902|NCT02652598|"~     The experimental design is an open-label two-week trial of tolcapone to evaluate which~     clinical domains are affected by tolcapone treatment and to identify responders to~     tolcapone treatment in the two subject groups (BI and NCD)~   "
30903|NCT02652585|"~     Using theTEMA (test system for development of medications for alcoholism) it can be shown,~     that naltrexone administration reduces the willingness to perform work for alcohol infusion~     in a laboratory experiment.~   "
30904|NCT02652572|"~     The purpose of this study is to determine the systemic exposure of Granexin® gel after~     topical application to human subjects' venous leg ulcers.~   "
30905|NCT02652559|"~     Rationale:~      Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive~     pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has~     recently been shown to improve survival and quality of life when applied with sufficiently~     high inspiratory pressures and adequate backup breathing frequencies (so called~     high-intensity NIV). However, for a broader implementation of this therapy in a potentially~     large group of patients, important issues have to be solved. First, the initiation of~     high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive~     and inconvenient for patients. Secondly, although clinicians recognise that not all patients~     benefit, it is not known which factors predict a positive response.~      Objectives:~        1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF~          is non-inferior to inpatient initiation.~        2. To investigate predictors of a favourable response to chronic NIV in COPD patients with~          CHRF.~      Study design:~      The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual~     inpatient NIV initiation to home initiation.~      Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or~     IV; partial arterial carbon dioxide pressure (PaCO2) > 6.0 kPa in stable condition, i.e. no~     COPD exacerbation for 4 weeks and a pH > 7.35), a sufficient social network at home, without~     severe cardiac comorbidities, will be included.~      Intervention: Home initiation of NIV will be compared with standard in-hospital initiation.~     NIV at home will be titrated by a specialised nurse of our home mechanical ventilation~     centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and~     will be adjusted with the use of telemedicine.~      Main study parameters/endpoints:~        1. To investigate non-inferiority of home initiation, the change in arterial carbon~          dioxide pressure after 3 months treatment will be the primary outcome. Secondary~          outcomes are safety, change in lung function, health-related quality of life (HRQoL)~          and costs.~        2. To investigate predictors of a favourable response, patient demographics, and baseline~          data on lung function as well as measures of respiratory muscle activity, arterial~          blood gases, comorbidities, inflammatory blood markers and anxiety and depressions~          scores will be collected of all patients.~   "
30906|NCT02652546|"~     Background:~      When there is a threat to the body, the immune system triggers inflammation. Too much~     inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick~     after they start HIV drugs because their recovering immune systems cause too much~     inflammation. Or their immune systems can become activated all the time. This can cause~     serious health problems. Researchers want to test if the drug CC-11050 helps treat~     inflammation in people taking HIV drugs.~      Objectives:~      To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs.~     To see if it reduces inflammation.~      Eligibility:~      People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1~     year.~      Design:~      Participants will be screened with:~      Medicine review~      Physical exam and medical history~      Blood and urine tests~      Chest x-ray~      Electrocardiogram (ECG): Soft electrodes on the skin record heart signals.~      Participants will be randomly assigned to take capsules of either CC-11050 or a placebo.~     They will take the capsules every day for 12 weeks. They will continue to take their HIV~     drugs.~      Participants will have a baseline visit within 2 months of screening. This includes:~      Physical exam and medical history~      Blood and urine tests~      ECG~      Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that~     removes white blood cells. The rest of the blood is returned through a needle in the other~     arm.~      Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit.~     These may include repeats of some of the baseline tests.~   "
30907|NCT02652533|"~     The investigators plan to investigate the use of US shear wave elastography (SWE), a newly~     available imaging technology, in children with suspected/known BA.~   "
30908|NCT02652520|"~     Kidney transplantation is the treatment of choice for end stage renal diseases, increasing~     life expectancy and quality of life. Improvement in organ preservation is a critical issue~     in this context.~      This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in~     organ preservation solution in kidney transplantation.~   "
30909|NCT02652507|"~     The purpose of this research study is to examine the effects of two commonly used anesthetic~     drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway~     in children, adolescents, and young adults.~      The results of this study will help in making the best decisions regarding the anesthesia~     medications used for sedation outside of the operating room.~   "
30910|NCT02652494|"~     This is a multicenter, prospective, non-interventional, observational single arm study.~      Two-hundred patients will be recruited in the Netherlands over a one year period. In all~     cases, the decision to treat the patient with apremilast will be made prior to the decision~     to enter the subject into this study. Treatment will be according to routine clinical~     practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment~     will continue until 200 patients have entered the study. Each patient will be followed for~     12 months.~   "
30911|NCT02652481|"~     The objective of this study is to collect data to confirm the safety and effectiveness of~     the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment~     under the labeled Conditions of Use~   "
30912|NCT02652468|"~     To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell~     and CD19 cell depletion using HLA haploidentical donors for peripheral blood stem cell~     transplant in relapsed lymphoma.~      Assess incidence of acute GVHD (Graft versus Host Disease), chronic GVHD, graft failure~     rate, treatment related mortality rate, progression free survival and overall survival of~     patients.~      The stem cell product will be processed using an investigational Miltenyi cell selection~     device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that~     are more likely to cause GVHD.~   "
30913|NCT02652455|"~     The purpose of this Pilot Study is to investigate the safety, side effects, and benefits of~     tumor- infiltrating lymphocytes (TILs) when they are given with the drug nivolumab.~     Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the~     immune system to fight cancer, infection, and other diseases.~      The primary endpoints of this pilot trial will be the safety and feasibility of the~     treatment regimens.~   "
30914|NCT02652442|"~     Recent studies suggest that otolith dysfunction is a common finding in individuals with a~     history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith~     dysfunction may be a significant health concern for the Veteran population, and determining~     optimal intervention strategies for otolith dysfunction is important for VA healthcare. The~     purpose of this project is to compare the effectiveness of standard vestibular~     rehabilitation compared to a novel treatment approach, centrifugation, in the treatment of~     individuals with otolith dysfunction.~   "
30915|NCT02652429|"~     An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial~     Hypertension (PAH)~   "
30916|NCT02652416|"~     Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects~     following oral administration of single rising doses (SRD) followed by multiple rising doses~     (MRD)~   "
30917|NCT02652403|"~     The purpose of this study is to evaluate the effectiveness of a simplified technique of~     conventional dentures fabrication, comparing it to a traditional technique, by evaluating~     the impact of oral health on quality of life, satisfaction of individuals and chewing~     efficiency as well assessing the quality of prosthetics and TMD. Furthermore, the cost~     involved in the manufacture of dentures through technique simplified will be compared to the~     cost involved in the traditional technique.~   "
30918|NCT02652390|"~     Between 2008 and 2012 the investigators performed a single-center randomized double-blind~     placebo-controlled trial to assess the efficacy of local injection of two different doses of~     methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18~     to 70 years, not previously treated with steroid injection. The primary outcomes were change~     in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on~     the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3~     groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed~     the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after~     injection.~   "
30919|NCT02652377|"~     This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of~     a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV)~     and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.~   "
30920|NCT02652364|"~     This study evaluates if strong ion gap on admission or 24 hours after admission to critical~     care unit can predict 28 day outcome in patients admitted with shock due to any cause~   "
30921|NCT02652351|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.~   "
30922|NCT02652338|"~     The main aim of this study, which was carried out in two parallel groups, is testing the~     efficacy of a specific micronutrients combination in adults with heart rhythm disturbances~     and accompanying symptoms.~      It is therefore the investigators hypothesis that daily oral administration of the specific~     micronutrients combination will lead to a decrease of symptoms awareness and to a reduction~     of heart rhythm disturbances in adults with or without structural heart disease. The~     principal endpoints will be a decrease in the total score of symptoms awareness.~   "
30923|NCT02652325|"~     To determine if routinely available 10% povidone-iodine swabs are more effective than saline~     and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.~   "
30924|NCT02652312|"~     The aim of this study is to calculate desflurane consumption when combined with~     intraoperative dexmedetomidine infusion guided by bispectral index (BIS)~   "
30925|NCT02652299|"~     This study will focus on a rare cell population called fibrocytes in peripheral blood and~     synovial tissue in Rheumatoid Arthritis (RA). One group of patients with early RA and one~     group with long-standing RA. Both groups will be followed for 6 months.~      After informed and written consent a control groups is also formed: One for synovial~     biopsies for patients undergoing a routine arthroscopy, where a peripheral blood sample is~     also taken.~      The hypothesis is that fibrocytes are present in the blood and synovial tissue in RA.~     Patients with early and long-standing RA have higher concentrations of fibrocytes in~     peripheral blood and synovial tissue compared to a control groups. Levels of fibrocytes in~     peripheral blood and synovial tissue are correlated with RA disease activity measures and~     imaging findings.~   "
30926|NCT02652286|"~     Video-assisted thoracic surgery (VATS) anatomical lung resection provides an effective~     minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is~     associated with significantly less postoperative atrial fibrillation, blood transfusion,~     renal failure, and other complications when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~     Complications include: pulmonary vascular injuries (Pulmonary artery (PA), pulmonary vein)~     necessitating urgent conversion to open thoracotomy and even death. Causes of conversion~     included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems~     including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper~     dissection of all tissue around PA branches is sometime difficult especially in the presence~     of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the~     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung~     resections were performed by VATS.~      The technical difficulty and danger of VATS lobectomy is directly related to PA branch~     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic~     surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the~     manipulation and dissection required by the surgeon on the PA branches, we can make these~     procedures safe and therefore more prevalent for anatomical pulmonary resections.~   "
30927|NCT02652273|"~     The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the~     effects of inhibiting costimulation on immune responses in patients with rheumatoid~     arthritis (RA).~   "
30928|NCT02652260|"~     This study aims to evaluate a switch from fixed dose combination (FDC) treatment with~     ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with MK-1439A in~     virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants.~     The primary hypothesis is that switching from ATRIPLA^TM to MK-1439A results in a lower~     proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at~     Week 12 than continuation of ATRIPLA^TM treatment.~   "
30929|NCT02652247|"~     To determine if the analysis of exhaled breath condensate correlates with the development &~     resolution of pneumonia.~   "
30930|NCT02652234|"~     This is an open-label, single-arm study to assess the safety, tolerability and~     pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.~   "
30931|NCT02652221|"~     A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to~     quantify liver stiffness in children and young adults with chronic liver disease. ARFI~     results will be compared to the current clinical standard of Magnetic Resonance Elastography~     (MRE) and to liver biopsy when available.~   "
30935|NCT02652169|"~     Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven~     therapeutic efficacy. This randomised controlled trial aims to provide evidence of the~     efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for~     antimicrobial compounds. The investigators therefore designed a four armed trial with three~     PRF arms which are compared to each other as well as to an active comparator. The treatment~     arms are as follows:~      Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium~     chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4:~     Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be~     included in this trial. Infection shall be diagnosed by an experienced senior infectious~     diseases specialist. Patients with untreated peripheral vascular occlusive disease as~     defined by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are~     patients with an uncontrolled diabetes mellitus or patients who have not received sufficient~     treatment for a diabetic foot syndrome. Any underlying illness will be treated following~     standard of care. In case of chronic venous insufficiency four-layered compression bandages~     will be applied each visit if tolerated by the patient. Alternatively compression stockings~     (Class III) are permitted. This is mentioned as Disease specific treatment in the~     protocol.~      Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be~     compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will~     be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each~     visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious~     diseases specialist.~   "
30936|NCT02652156|"~     This clinical trial will examine differences in the effectiveness between three (3) commonly~     used methods and/or medications used to perform a transversus abdominis plane (TAP) block~     for post-operative pain control. The transversus abdominis muscle is either side between the~     lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief~     treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects~     will undergo post-operative pain relief treatment with a single injection of Exparel®, a~     liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a~     continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be~     no placebo group in this study.~   "
30937|NCT02652143|"~     This Clinical Study has been designed to assess and compare the impact of in vitro or in~     vivo culture conditions on the euploidy of sibling blastocysts.~   "
30938|NCT02652130|"~     Ongoing safety assessment follow up to Protocol MSB-GVHD 001 of remestemcel-L treatment in~     pediatric subjects with acute Graft versus Host Disease (aGVHD), following allogeneic~     hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with~     systemic corticosteroid therapy.~   "
30939|NCT02652117|"~     This retrospective review presents a comparison of pediatric patients less than 5 years old~     undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal~     epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time~     to extubation, reintubation, and hypercarbia.~   "
30940|NCT02652104|"~     This study reviews the outcome of deep brain stimulation treated patients in Helsinki and~     Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate~     the outcome and possible side effects of deep brain stimulation treatment.~   "
30941|NCT02652091|"~     The primary objective of this study is to assess adherence and persistence to BETASERON~     therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).~      The secondary objective of this study is to assess patient-reported satisfaction with the~     BETACONNECT device.~   "
30942|NCT02652078|"~     Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year~     olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a~     short distance and increases in intensity until the person stops, where the pain then~     gradually subsides. It can be limiting or occasionally debilitating and has been shown to~     have considerable deleterious effects of patients quality of life. Shock wave therapy has~     been shown to promote new blood vessel formation and improved healing amongst other~     findings. This study aims to identify whether shock wave therapy that is applied to the calf~     muscles causes such an effect to improve the blood supply to the calf muscles, reduce pain,~     improve walking ability and quality of life.~   "
30943|NCT02652065|"~     Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French~     population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their~     pathology.~      Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing~     that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.~      The investigators hypothesize that there is a link between cutaneous sensory neuropathies~     and altered cutaneous microcirculation during psoriasis.~      In order to test this hypothesis, local vasodilators will be delivered to patients by~     iontophoresis and their skin blood flow in response to these molecules will be followed by~     laser Doppler recordings. Two recordings will be performed for each patient, both on a~     psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal~     control.~   "
30944|NCT02652052|"~     The investigators hope to find the proof of principle concept from this pilot study so that~     the investigators can design a clinical trial based on the results of the explanatory~     hypothesis.~   "
30945|NCT02652039|"~     The purposes of this study were 1) to delineate any differences in general musical taste~     (trait) and context-specific music preference (state), as well as preferred music~     characteristics in cancer patients, 2) to investigate the contributions of individual~     variabilities, personality, behavioral coping styles, and pain levels in predicting changes~     from trait to state preferences and preferred music characteristics under various pain~     conditions.~      Cancer patients were recruited to fill in questionnaires pertaining to their demographic~     information (age, gender, religious preference, ethnicity, music background and experience),~     personality traits, music preferences, preferences for music characteristics, coping styles,~     and pain experiences.~   "
30946|NCT02652026|"~     The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum~     levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month,~     single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic~     generalized periodontal disease will be randomly divided into 2 groups: Treatment Group,~     Control Group.~   "
30947|NCT02652013|"~     Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why~     individuals faced with this chronic disease whose progression is unpredictable have to~     mobilize all their available resources. As a result, management of interpersonal~     relationships appears to be a key issue in adjustment to situations.~      Although knowledge on cognitive abnormalities in MS has been growing in recent years, there~     is a lack of research about social behaviour regulation skills. The few studies conducted in~     this field are mainly interested in emotional processing (emotional facial recognition and~     empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.~      While some recent studies touch on the issue of the contextual analysis of language (that is~     to say, the social use of language) in MS, their assessment on a wide range of pragamtic~     skills has never been studied. However, the pragmatic aspects of language are known to play~     a major role in social adjustment.~      This project has three main objectives : (1) to increase general knowledge of deficits in~     communication and in social cognition in patients with MS, (2) to propose new leads for the~     evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis~     of communication and social cognition.~      In order to address those objectives, the assessment will be focused on many various~     pragmatics skills : conversation, indirect language comprehension (indirect questions,~     idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS~     patients. Those patients' performances will be compared to a group of healthy matched~     control subjects, potential relationships between pragmatic abilities, other aspects of~     social cognition (theory of mind and processing of emotional stimuli), cognitive~     functioning, psycho-behavioural aspects and the characteristics of the disease will be~     explore.~      Social cognition tasks have been selected for their dynamic and ecologic aspects in order to~     match natural social interaction.~      Finally, communication consideration, cognitive and cerebral skills of patients with MS will~     contribute to increasing knowledge of the neural basis of social cognition.~   "
30948|NCT02652000|"~     Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for~     localized prostate cancer~   "
30949|NCT02651987|"~     This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg~     administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced,~     unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have~     progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.~   "
30950|NCT02651974|"~     This is a sub-study nested within a previously initiated clinical study (# NCT01946282)~     focusing on individuals not previously randomized at baseline to the original interventions.~     The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3~     strategies for promoting screening completion among individuals not up to date with~     colorectal cancer screening, but assigned to receive screening outreach.~   "
30951|NCT02651961|"~     Chronic infection after total joint arthroplasty generally requires implant exchange. Two~     stage exchange is considered as the gold standard procedure. However, some authors suggest~     that one stage exchange may be as effective. No consensus exists in the current literature.~     The purpose of the study was to evaluate the cost of both strategies in comparison to their~     success rate.~   "
30952|NCT02651948|"~     Primary purpose:~      Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are~     reduced than transrectal prostate biopsies.~      Secondary purposes:~        -  Patients tolerance after transperineal prostate biopsy MRI-guided is better than after~          transrectal prostate biopsies.~        -  Core of transperineal prostate biopsies are better than core of transrectal prostate~          biopsies~        -  Study of correlation between radiologic images and anatomopathologic result~        -  Description of needle track during the procedure~        -  Description of real time template saturation prostate biopsy~        -  Comparison of transperineal prostate biopsy relevance according to EBM~        -  Comparison of 1.5T MRI and 3T MRI for prostate cancer detection~   "
30953|NCT02651935|"~     This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent~     ASV) on the duration of ventilation compared to conventional modes in COPD patients.~   "
30954|NCT02651922|"~     The study was carried out as a prospective, non-interventional study with the intention of~     subsequent process cost analyses (PCA) and also considers quality of life, drug misuse,~     dependence, adverse events and therapy satisfaction.~   "
30955|NCT02651909|"~     The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in~     trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.~      Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that~     is widely used in trauma and is viewed by many as superior to standard coagulation studies~     for the assessment of coagulopathy following injury and may be useful in detecting~     rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa~     impairment.~   "
30956|NCT02651896|"~     Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer~     high-fraction-size treatments would be beneficial for prostate cancer because it would~     deliver a larger biological-equivalent dose to the tumor than would conventional treatment~     in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal~     tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT~     treatment for localized prostate cancer will improve the therapeutic ratio by either:~        1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or~        2. Improving tumour control, mainly freedom from biochemical failure survival.~   "
30957|NCT02651883|"~     This study will investigate whether cervical cancer screening completion among~     under-screened women could be improved by offering HPV (human papillomavirus) testing by~     at-home self-collection followed by screening invitation compared to screening invitation~     alone.~   "
30958|NCT02651870|"~     A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan~     and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately~     Controlled by Candesartan Monotherapy~   "
30959|NCT02651857|"~     Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic~     Systems Utilizing EndoChoice's Full Spectrum Optical Technology~   "
30973|NCT02651675|"~     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder~     characterized by absent or severely reduced capacity to catabolize circulating LDL particles~     by the hepatic LDL receptor. As a consequence, HoFH subjects present abnormal total plasma~     cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset~     of cardiovascular disease. Early initiation of aggressive treatment for these patients is~     therefore essential. Unfortunately, despite existing therapies, treated LDL-C levels could~     remain well above acceptable levels. Thus, the functional replacement of the defective LDLR~     via AAV-based liver-directed gene therapy may be a viable approach to treat this disease and~     improve response to current lipid-lowering treatments. This first-in-humans study is~     intended to evaluate the safety of this gene therapy investigational product and assess~     preliminary evidence of efficacy using plasma LDL-C levels as a surrogate biomarker for~     human LDLR transgene expression.~   "
30960|NCT02651844|"~     -  Seventy per cent of breast cancers express estrogen (ER) and progesterone receptors~          (PR) and respond to endocrine treatment.~        -  Actual therapy targets ER.~        -  There is enough evidence that progestins participate regulating breast cancer growth.~        -  Antiprogestins block cell proliferation and increase apoptosis in breast cancer models~          which express high levels of PRA.~        -  Antiprogestins have been used to treat breast cancer patients that failed to other~          treatments; benefits were seen in selected patients.~        -  Mifepristone (MFP) is currently used for medical abortion and for the treatment of~          Cushing disease.~        -  MFP might exert agonistic effects when PRB isoform is activated by cAMP. This makes~          mandatory the evaluation of the PR isoform ratio in breast cancer patients in which MFP~          is a therapeutic possibility.~      Main Goal To evaluate if therapeutic doses of MFP exert beneficial effects on breast cancers~     expressing levels of PRA higher than those of PRB, evaluated as an inhibition in~     proliferation markers and/or an increase in apoptotic markers.~        -  Eligibility~             -  Postmenopausal women (one year after menses stop).~             -  Women with tumors showing ratios of PRA/PRB higher than 1.5 and PR higher than~               50%.~             -  Women without previous treatment.~             -  All clinical stages with tumors larger than 1.5 cm.~             -  Patients without autoimmune diseases and/or asthma.~        -  Study design~             -  Open Interventional.~             -  Twenty women will take MFP (200 mg) p.o. once /day during 14 days. As for~               preliminary studies, to reach this number the investigators will have to evaluate~               80-100 patients.~             -  Surgery is performed 14 days after treatment initiation, 24 hs after last dose.~             -  PR isoform ratio will be evaluated by western blots (WB) in one core biopsy.~               Additional cores will be used for diagnosis, immunohistochemistry (IHC) of PR,~               Ki-67 and other markers.~             -  At surgery samples will be frozen for molecular studies and fixed and processed~               for pathological evaluation.~             -  Wilcoxon signed rank test will be used to evaluate differences in biomarker~               expression between core biopsy and surgical samples of each patient.~             -  Blood will be collected before treatment initiation and prior to final surgery.~             -  Mammographic and echographic studies will be carried out before and after~               treatment.~   "
30961|NCT02651831|"~     This study aims to develop a health related quality of life (HRQOL) patient reported outcome~     (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument~     could be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs~     and ICM combinations that might ultimately influence decisions about regulatory approval, as~     well as improved understanding of chronic treatment effects on patient well-being,~     understanding reasons for treatment non-adherence, and developing strategies to improve~     adherence and evaluating clinical outcomes.~   "
30962|NCT02651818|"~     The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on~     the disease specific quality of life evaluated 6 months after thyroid surgery.~      All investigations follow already scheduled treatments.~   "
30963|NCT02651805|"~     Patients with advanced chronic diseases may suffer with respiratory secretion and available~     therapies to control this condition are uncomfortable or little effective in palliative care~     patients. Therefore, alternative therapies should be tested, assessing clinically relevant~     outcomes in palliative care, such as comfort during therapy and the number of interventions~     required in a day. Mechanical Insufflation-Exsufflation is an option that presents~     advantages, since it can be used in patients with minimum cooperation and is non-invasive,~     which may lead to higher comfort during therapy.~      The aim of the study is to verify the feasibility of a clinical trial comparing the effects~     of Mechanical Insufflation-Exsufflation with usual care in hospitalized palliative care~     patients that are suffering with respiratory secretion. Patients allocation will follow a~     fast-track allocation design, in which included patients will be randomized in two groups:~        1. Receive Mechanical Insufflation-Exsufflation therapy in the moment that is assigned to~          this group;~        2. will receive 24h of usual care and after that will be allowed to choose between usual~          care or Mechanical Insufflation-Exsufflation Therapy.~      The assessments will be: Time from the first intervention until the need of a following~     intervention, discomfort due therapy, discomfort due respiratory secretion, palliative~     outcome scale, number of adverse events and number of interventions during 24h period. The~     primary outcome is to verify the feasibility of developing a future larger clinical trial to~     assess the effects of the use of Mechanical Insufflation-Exsufflation to control respiratory~     secretions in patients in palliative care.~   "
30964|NCT02651792|"~     The investigators aim to investigate the differences between ketamine propofol and pethidine~     propofol during ERCP in respect to endoscopist satisfaction.~   "
30965|NCT02651779|"~     There is no consensus about the best treatment for patients with displaced complete~     articular distal radius fractures (AO type C fractures). Despite this lack of consensus and~     the lack of available literature on comparative data to guide treatment for this patient~     population, operative treatment with plate fixation has gained popularity. The aim of this~     study is to compare the functional outcome of open reduction and plate fixation with closed~     reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete~     articular distal radius fractures.~   "
30966|NCT02651766|"~     The study aims to investigate the influence of 5 cupping massage treatments on chronic non~     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and~     waiting list control group. Before and after the intervention the investigators evaluate the~     neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality~     of life (SF36) and safety. To investigate neurophysiological effects of cupping the~     investigators also measure mechanical detection threshold (MDT), vibration detection~     threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold~     at pain related and control areas.~      The treatment group receives 5 cupping treatments over a period of 3 weeks.~   "
30967|NCT02651753|"~     This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to~     compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.~   "
30968|NCT02651740|"~     The purpose of this study is to evaluate the efficacy as well as safety of rifaximin and~     fecal microbiota transplantation in the treatment of IBS-D.~   "
30969|NCT02651727|"~     The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in~     combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to~     determine a recommended Phase 2 dose (RP2D) for further development of this combination in~     subjects with untreated advanced pancreatic cancer.~   "
30970|NCT02651714|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in~     the United States in subjects with treatment-resistant pruritus diagnosed with atopic~     dermatitis.~   "
30971|NCT02651701|"~     The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET~     for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT~     and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative~     imaging modality in patients with rectal cancer.~   "
30972|NCT02651688|"~     The purpose of this study is to compare the effects of 12 months of treatment with~     enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic~     parameters in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning~     T≤300 ng/dL) following a 6 month diet and 15 month exercise program.~   "
30975|NCT02651649|"~     Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor~     maternal and fetal outcomes. The investigators propose a prospective observational study to~     assess the utility of continuous positive airway pressure (CPAP) administration~     (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will~     also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing~     as measured by ambulatory sleep monitoring applied in the hospital setting.~   "
30976|NCT02651636|"~     The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic~     acid and myoinositol on clinical, endocrine and metabolic features of women affected by~     PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic~     acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The~     investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose~     tolerance test, lipidic profile at baseline and after six months of treatment.~   "
30977|NCT02651623|"~     The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals~     relative to time-matched placebo in healthy subjects~   "
30978|NCT02651610|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug taxane, will improve the results of~     the treatment for HER2-negative metastatic breast cancer.~   "
30979|NCT02651597|"~     The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat~     β-glucan on post-prandial glycemic response in healthy adult participants.~   "
30980|NCT02651584|"~     Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group~     multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an~     existing standard of care (SL BPN) in initiation and maintenance treatment with BPN.~   "
30981|NCT02651571|"~     The total knee replacement has become a routine procedure. Survival rate of over 90% after~     10 years are generally reported. However, complications and reoperation may still occur for~     many reasons, and some of them may be related to component design: loosening (tibial above),~     polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs~     can, at least in theory, improve the results of conventional models.~      In this study, the investigators want to compare retrospectively data concerning survival~     rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with~     the ones published in the literature for conventional fixed-bearing prostheses.~   "
30982|NCT02651558|"~     Comparison of an optical method to continuously measure blood pressure against an invasive~     arterial catheter.~   "
30983|NCT02651545|"~     Cognitive impairment is common in MS and has devastating impact on functional activities.~     There is a great demand for medications that will enhance cognitive capacity in MS patients.~     The effect of teriflunomide on cognition and vocational capacity is unknown. The~     investigators will address these questions in a sample of 30 relapsing MS patients treated~     with teriflunomide. Cognitive impairment will be measured by calculating an information~     processing speed index and a memory composite index from conventional, validated~     neuropsychological tests as recommended by consensus opinion publications. Vocational~     performance will be monitored using a newly developed online survey called the Multiple~     Sclerosis Vocational Monitoring Survey (MSVMS). This study will elucidate the effect of~     teriflunomide on these important outcomes.~   "
30984|NCT02651532|"~     Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has~     prevalence in general population of 5-20% and is more common in women and young adults.~      Despite being one of the most frequent reasons for consultation many patients are~     undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome~     III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with~     changes in bowel frequency and consistency, when other etiologies are excluded. The~     combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity~     of 65%, specificity of 100%, 100% positive predictive value and negative predictive value of~     76%.~      Current tests commonly fail to obtain an objective diagnosis, and effective therapies are~     lacking. There are no specific endoscopic findings that can discriminate IBS patients from~     healthy patients. Most colonoscopies are performed to rule out other etiologies and in more~     than 50% of the cases are normal.~   "
30985|NCT02651519|"~     Stellate-ganglion block have been done safely for more than 60 years. It has proved to~     provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with~     few or no side-effects. The aim of the present study is to evaluate postoperative sleep~     quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed~     in the operation.~   "
30986|NCT02651506|"~     The use of computed tomography (CT) screening has allowed for early detection of lung~     cancers as small as 5mm in diameter. Early stage cancers are highly curable with a reported~     survival of greater than 90% over 5 years after surgical resection. Before a patient can~     have surgery, a biopsy must be performed. One common method is a transthoracic needle biopsy~     (TTNB). In this procedure, a CT-image is used to locate the area for biopsy. Once~     identified, the radiologist applies a local anesthetic and inserts an aspiration needle~     through the ribs, and into the lung tissue. The sampled lung tissue is then sent to~     pathology. Although this procedure has a diagnostic yield ranging between 70% and 85%, it is~     associated with serious complications such as pneumothorax, hemoptysis, infection,~     hemothorax, air embolism and there is about a 20% (range 9%-54%) incidence of pneumothorax,~     or air leak from the lung, requiring chest tube drainage. Additionally, about 5-15% of cases~     experience hemoptysis, or coughing blood, although significant life-threatening hemoptysis~     is only present in less than 1% of patients. When these complications occur, hospitalization~     as inpatients is required, with an average length of stay of 1-3 days.~      A new form of technology to localize and biopsy peripheral lung lesions is believed to~     significantly reduce the amount of complications that can occur during a biopsy. This~     technology is known as Electromagnetic Navigation Bronchoscopy (ENB). ENB uses~     electromagnetic tracking and CT-generated virtual bronchoscopy to create a three-dimensional~     GPS map of the lung, guiding the surgeon directly to the tumor. The surgeon is then able~     to perform bronchoscopy and biopsy the tumor from inside the bronchus. A recent systematic~     review and meta-analysis of 15 trials reports a pneumothorax rate of 3.1%, with only 1.6% of~     patients requiring chest tube drainage. Initial studies demonstrate a slightly lower~     diagnostic yield for ENB as compared to TTNB; however, a systematic exploration of study~     heterogeneity reveal that lung nodules included in TTNB studies are larger than those~     included in the meta-analysis of ENB yield. The review further identified six variables~     associated with increased diagnostic yields for ENB, including combined use of an~     ultrasonic radial probe and catheter suctioning as a sampling technique. The~     superDimension® InReach™ System was granted Health Canada approval on July 23, 2009.~      There have been no studies directly comparing ENB to TTNB, either retrospectively or~     prospectively. Initial systematic reviews demonstrate that ENB may have a slightly lower~     diagnostic yield relative to TTNB. Selection bias and low study quality may have resulted in~     an underestimation of the true diagnostic yield associated with ENB. The literature also~     confirms that ENB has a significantly better safety profile as compared to TTNB. As such, a~     prospective comparison between the two techniques is mandated. This Phase II pilot~     feasibility trial will utilize randomized methodology to gather the preliminary data that is~     required for the successful completion of a Phase III randomized controlled trial to compare~     lung biopsy with ENB verses TTNB. This study will also be the first time ENB lung biopsy is~     documented in Canada.~   "
30987|NCT02651493|"~     In this study, the investigators propose a novel method to detect Down syndrome using~     photography for facial dysmorphology, a tool called computer-aided diagnosis (CAD). After~     validating the method, this technology will be expanded to perform similar functions to~     assist in the detection of other dysmorphic syndromes.~      By using photography and image analysis this automated assessment tool would have the~     potential to improve the diagnosis rate and allow for remote, non-invasive diagnostic~     evaluation for dysmorphologists in a timely manner.~   "
30988|NCT02651480|"~     The proposed study seeks to test the effect of a plant-based dietary intervention on~     cardiovascular risk factors in police officers.~   "
30989|NCT02651467|"~     This will be a single center, eight week, randomized, double blind, three treatment arm,~     parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected~     test teeth) study in healthy participants.~   "
30990|NCT02651454|"~     The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and~     Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors~   "
30991|NCT02651441|"~     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined~     with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer~     (NSCLC).~   "
30992|NCT02651428|"~     The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter~     lock solution, for prevention of central venous catheter associated bloodstream infection in~     hemodialysis patients.~   "
33888|NCT02613494|"~     A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the~     treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in~     a multi-centre trial.~   "
30993|NCT02651415|"~     The purpose of this study is to find out what effects the combination of regorafenib and~     perindopril has on hand-foot skin reaction (HFSR), on high blood pressure (hypertension) and~     on any other types of side-effects and compare it to the published incidence of the~     side-effects with regorafenib alone.~      This research is being done in an attempt to reduce the side-effects associated with~     regorafenib.~   "
30994|NCT02651402|"~     Unresolved psychological problems, such as anxiety, affect a significant number of our~     students and interfere with their ability to attend, actively participate, and prosper in~     school. This project will expand the capacity of selected mental health agencies to provide~     services in the participating schools through school therapeutic services (STS). The project~     will provide enhanced training in evidence-based behavioral health interventions to~     school-based mental health providers. The services will be implemented by STS Bachelor's or~     Master's level therapists supervised by their mental health agency supervisors (Internal~     Support), who are in turn supported by the research team (Train-the-Trainer) or external~     consultants (Train the Trainer+).~   "
30995|NCT02651389|"~     This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.~   "
30996|NCT02651376|"~     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually~     leads to clinically significant immunodeficiency. Severely immunosuppressed patients often~     experience an increased risk of opportunistic infection. A chronic generalized immune~     activation is now being recognized to be the main driving force for T cell depletion, loss~     of anti-HIV-1 immunity and disease progression during chronic HIV-1 infection. However, it~     is still unknown whether reducing immune activation will restore CD4 T cell counts and~     leading to the restoration of immunodeficiency in chronic HIV infection.Granulocyte~     colony-stimulating factor-mobilized donor peripheral-blood stem cells based on HLA~     mismatched allogeneic transplantation have been demonstrated to boost host immunity against~     tumor, attenuate immune-mediated inflammation, promote hemopoiesis without acute~     graft-versus-host disease. Thus, it may represent a novel treatment as adoptive therapy of~     allogenic adoptive cell therapy (AACT). Here, the investigators propose a hypothesis that~     AACT therapy can promote hemopoiesis in bone marrow and attenuate immune-mediated~     inflammation, which subsequently lead to the restoration of immunodeficiency in HIV-infected~     patients.~   "
30997|NCT02651363|"~     The purpose of this study is to collect adverse events and identify risk factors in patients~     that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®~   "
30998|NCT02651350|"~     This study is to observe the efficacy and safety of glucocorticosteroid treatment in the~     patients with chronic recurrent drug-induced liver injury (DILI).~   "
30999|NCT02651337|"~     The objective of this pilot study is to perform a set of pressure and flow rate measurements~     in order to quantitatively characterize safe irrigation or flushing of a ventricular shunt~     catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery.~     This maneuver involves injecting saline with a syringe to clear plugged shunt catheters.~     Based on data obtained in Stage I of the study, a device has been fabricated which provides~     the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure~     and flow rate measurements generated by this specialized flusher device will be collected~     and measured.~   "
31000|NCT02651324|"~     This study hypothesizes that the addition of a low-dose ketamine infusion to usual~     post-operative pain management will improve pain control as evidenced by an improvement in~     post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.~   "
31001|NCT02651311|"~     Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at~     birth or shortly after birth, primarily resulting from unilateral shortening of~     Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some~     children, which is accompanied by moderate pain and discomfort. The investigators focused~     the effectiveness of intermediates cervical plexus block because the dermatome of sensory of~     cervical plexus block is correlated to that of torticollis. So the effect of analgesia could~     decrease the use of analgesics.~   "
31002|NCT02651298|"~     Fractional Co2-laser for treatment of mature caesarean section scars.~   "
31003|NCT02651285|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may~     improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF~     cycles.~   "
31004|NCT02651272|"~     This is a pilot study to assess the safety and efficacy of macitentan in patients with~     pulmonary hypertension of sickle cell disease. This study will enroll approximately 10~     subjects. Study participation for each subject will last approximately 24 weeks from~     screening to end of treatment follow-up.~   "
31005|NCT02651259|"~     The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of~     once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and~     HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).~   "
31006|NCT02651246|"~     The primary goal of this optional sub-study is to record what tissues fluoresce in the~     operating room, and then to identify if these lesions are cancer when the histopathology is~     performed.~   "
31007|NCT02651233|"~     Human adipose tissue has been shown to contain a group of cells that possess extensive~     proliferative capacity and the ability to differentiate into multiple cell lineages. Cells~     isolated from the fatty portion are termed processed lipoaspirate cells that contain~     adipose-derived regenerative cells (ADRCs). ADRCs are most conveniently extracted from~     tissue during an elective cosmetic liposuction procedure but may also be obtained from~     resected adipose tissue.~      This study is aimed to verify if there are differences between the number and viability of~     cells obtained from patients with different age, sex, Body Mass Index (BMI), smoking and~     physical activity, within the different amount of processed fat.~   "
31008|NCT02651220|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical~     Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide~     gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl~     peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris~   "
31009|NCT02651207|"~     Study to look at the acceptability of local anaesthetic spray versus injection, prior to~     contraceptive implant insertion~   "
31011|NCT02651181|"~     Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well~     as reduce glycemic variability.~      Several groups around the world investigate efforts in developing closed-loop systems.~     Investigators combined two closed-loop systems with different mode of operation in order to~     enhance the closed-loop system. The two systems are Hybrid closed-loop system and the~     MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was~     tested 'In silico' and was proved to be safe and effective. The next step is to test the~     system in a clinical study in a supervised environment in a camp.~      The two systems were tested separately in several clinical studies and were proven to be~     safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic~     system for overnight use the GlucoSitter has a CE mark.~      The purpose of this study is to collect data on the feasibility of the HLCL system in a camp~     setting.~   "
31012|NCT02651168|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This~     condition can develop in diabetics where swelling results from leaking of fluid from the~     blood vessels of the eye, into the center of the retina, the macula. If left untreated, this~     can affect central.~      The current standard treatment for diabetic macular edema includes medications injected~     directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are~     injected directly into the eye are known as anti-VEGF agents which help to reduce the~     leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).~      However, some patients do not respond well to these anti-VEGF treatments and will be given~     the option of switching to an another newer anti-VEGF medication, called aflibercept~     (Eylea®) that is approved to treat DME. A recent large study has demonstrated that~     aflibercept was as efficacious as other anti-VEGF therapies listed above and was even~     superior in patients with worse vision (Diabetic Retinopathy Clinical Research Network,~     Wells JA, Glassman AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular~     Edema. N Engl J Med. 2015:150218140025008-150218140025008).~      The purpose of this study is to determine what factors affect the treatment response to~     aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who~     were previously unresponsive to ranibizumab injections.~   "
31013|NCT02651155|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of~     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
31014|NCT02651142|"~     Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal~     metastasis in early breast cancer. We aim to determinethe，in a prospective randomized,~     controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN)~     dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on~     outcomes after breast surgery.~   "
31015|NCT02651129|"~     The effect of noise is often underestimated but it is one of the most common occupational~     health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance,~     interference with speech comprehension, complaints, stress, annoyance, and safety concerns~     with regard to workers being able to complete their tasks in a safe manner.~      This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital~     during elective and emergency cesarean deliveries.~   "
31016|NCT02651116|"~     This is a placebo-controlled, double-blind, randomized, parallel group pilot study in~     approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM)~     on acute cough in a pediatric population. Subjects will be otherwise healthy males and~     females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or~     upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of~     screening and qualify based on physical exam and symptom questionnaire. Eligible subjects~     will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour~     run-in period. Qualifying subjects will be stratified by age and then randomized to either~     DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24~     hours of treatment. Subjects will receive approximately 9 doses of investigational product~     over the course of the 4 day study and will complete patient reported outcome questions~     before the morning and afternoon doses. Subjects will return to the study site on Day 2 to~     remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of~     any reported adverse events will also be completed.~   "
31017|NCT02651103|"~     The proposed research aims to investigate how different ventilation strategies may affect~     cerebral tissue oxygenation in the pediatric population. It will contribute to the~     literature exploring the NIRS monitoring device which is becoming increasingly utilized in a~     variety of anesthetic and critical care settings. It may help to guide clinical practice~     regarding optimal ventilation strategies, and how ventilation may be altered to correct~     suboptimal cerebral tissue oxygenation.~      This prospective study will include 50 patients undergoing posterior spinal fusion that~     requires placement of an arterial cannulation. There will be no change in the anesthetic or~     perioperative care of these patients. Tissue and cerebral oxygenation will be monitored~     using near infrared spectroscopy (NIRS).~   "
31018|NCT02651090|"~     Patients with renal failure or other reason for contraindication for contrast enhanced~     computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with~     suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound~   "
31019|NCT02651077|"~     The investigators wish to highlight, in a Case-Control design, if there is an increased~     concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis~     with surgical indication ) versus bioaccumulation recorded in a control cohort ( women~     recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis~     ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes~     described by the HAS) and previous breastfeeding experience (yes / no , opposite the release~     expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .~   "
31020|NCT02651064|"~     The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on~     fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and~     Assistance Program (SNAP).~   "
31021|NCT02651051|"~     The purpose of this study is to investigate whether the addition of whey protein to a~     breakfast high in fat content will influence acute metabolic and appetite responses, as well~     as responses to a subsequent lunch meal.~   "
31022|NCT02651038|"~     Micafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of~     this class of antifungal agents are known to inhibit the synthesis of glucan polymers in~     fungal cell walls. The spectrum of activity of micafungin includes Candida (all species,~     including strains resistant to fluconazole), Aspergillus, and Pneumocystis.~      In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a~     well-established extracorporal renal replacement therapy with a high clearance rate.~      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF~     are rare. Elimination of any given drug by renal replacement therapy is determined by~     several major factors which are membrane specific, due to physico-chemical properties of the~     drug and characteristics of the renal replacement technique used.~      Ten intensive-care patients with acute renal failure and suspected or proven candida~     infection are included into the study.~      100 mg Micafungin will be infused over a period of sixty minutes via a central venous~     catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on~     days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6,~     8 and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from~     the outlet of the ultrafiltrate compartment of the hemofilter, will be taken at~     corresponding times.~      The following pharmacokinetic parameters will be determined: area under the curve (AUC),~     half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.~   "
31023|NCT02651025|"~     The purpose of this study is to determine whether a supervised resistance exercise training~     during hemodialysis is effective to increase physical activity in daily life in patients~     with end stage renal disease.~   "
31024|NCT02651012|"~     A Study to Evaluate the Efficacy and Safety Sarecycline in the Treatment of Acne Vulgaris.~   "
31025|NCT02650999|"~     Single center, phase I/II trial of pembrolizumab after CTL019 for CD19+ lymphomas. Patients~     will have CD19+ diffuse large B-cell, follicular, or mantle cell lymphomas~     relapsed/refractory after CTL019. 12 total patients will be enrolled. Safety of~     pembrolizumab (primary endpoint) will be determined using a Bayesian monitoring rule for~     treatment-related adverse events causing drug discontinuation. Secondary efficacy endpoints~     include overall response rate and progression-free survival.~   "
31026|NCT02650986|"~     This phase I/IIa trial studies the side effects and best dose of a gene-modified T cells and~     to see how effective it is in treating patients with solid tumors expressing cancer-testis~     antigens 1 (NY-ESO-1) gene that have spread from where it started to nearby tissue or lymph~     nodes (locally advanced) or have spread to other places in the body (metastatic). A T cell~     is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a~     modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then given them~     back to the patient may help the body build an immune response to kill tumor cells that~     express NY-ESO-1. Drugs used in chemotherapy, such as cyclophosphamide work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading, and it may also allow genetically modified T~     cells to grow.~   "
31027|NCT02650973|"~     This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess~     PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of~     CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during~     each period.~   "
31028|NCT02650960|"~     The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of~     life balance, will be validated in a stroke population. Upon approval by the ethical~     committee, stroke patients will be recruited when they are at least six months post stroke~     (n = 30). The LBI will be administered twice with one week interval, and demographic,~     socio-economic variables and other measures of health related quality of life will be~     collected.~      Next, an observational prospective longitudinal study will be set up. We will recruit stroke~     patients in three rehabilitation centers within one week after admission in the~     rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed~     at discharge from the rehabilitation center, at six months and at 12 months post stroke. A~     standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and~     functional outcomes as well as personal and environmental factors will be administered. This~     observational study will explore recovery patterns of bimanual activities after stroke from~     baseline evaluation to six and 12 months after stroke. Also the predictive value of motor,~     sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post~     stroke is studied, based on data collected on admission to the rehabilitation center.~     Finally, changes over time in life balance and its determinants will be examined at six and~     12 months post stroke. The predictive value of motor, cognitive and functional outcomes on~     life balance at one year post stroke will be examined, based on data collected on admission~     to the rehabilitation center. Furthermore the influence of bimanual activities on life~     balance will be explored in the chronic stage after stroke.~   "
31029|NCT02650947|"~     Hypothesis:~        1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone~          secretion and gut microbiota in healthy adults.~        2. Long-term consumption of sucralose may alter food behaviour in healthy adults.~   "
31030|NCT02650934|"~     Objective: The purpose of this project is to study the post miyocardial infaction (MI)~     damage and subsequently developed post-infarct cardiac repair process on the basis of~     cellular, molecular and imaging techniques. Besides this, whole genomesequencing and~     analysis (GWAS) will be performed to determine common varying genetic loci in order to~     anticipate whetherthese findings and its related pathways would be the predictors of adverse~     remodeling after MI or not.~   "
31031|NCT02650921|"~     This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness~     and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the~     dorsal hand to correct volume deficits.~   "
31032|NCT02650908|"~     The most common technique involves a suture meniscus avivement with a rasp or a motorized~     cutter the suture zone before actual implementation of the suture. But the imperative nature~     of this avivement is based only on theoretical considerations. The team has an old~     experience in conducting meniscus sutures without avivement. It therefore seems interesting~     to compare results with those of literature~   "
31033|NCT02650895|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     intravenous (IV) doses of CD24Fc in healthy adult subjects.~   "
31034|NCT02650882|"~     This study investigated the effects of an inspiratory muscle training (IMT) program on the~     respiratory muscle strength and resistance and the aerobic physical performance (PP) of~     handball athletes. Nineteen male athletes took part in the study, allocated at random into~     the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years~     old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the~     maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular~     respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic~     PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted~     to an IMT protocol 5 times a week for 12 weeks.~   "
31035|NCT02650869|"~     This prospective randomized double-blind control trial is carrying out in the neonatal unit~     of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015~     with the diagnosis of preterm (<33 weeks gestation) VLBW (birth weight <1500g) and~     fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of~     life) were included in this study. Babies with suspicion of clinical sepsis, presence of~     perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal~     illness were excluded. Gestation was assessed from history of last menstrual period and~     after birth by new Ballard scores. A study protocol was approved by the Institutional Ethics~     Committee of Sylhet M.A.G Osmani Medical College, Sylhet.~   "
31036|NCT02650856|"~     The investigators will include patients who will be schedule for total knee arthroplasty~     with a diagnosis of osteoarthritis. The patients will be divided in two groups. In both~     groups a verbal and clear detailed information will be given on the intraoperative approach.~     The first group will receive topical tranexamic acid and the second group topical platelet~     rich plasma; both in the surgical site. Both groups will be assessed before and after the~     intervention with clinical scales (VAS) and laboratory results (hemoglobin, hematocrit~     levels) and transfusion rate.~   "
31037|NCT02650843|"~     This project aims to clarify the role non-motor symptoms in the development of Parkinson's~     disease (PD) and to improve diagnostics at very early stages of PD. The project involves~     multidimensional measures of disease biomarkers together with brain dopamine transporter~     (DAT) imaging with [123I]FP-CIT single photon emission computed tomography (SPECT).~   "
31038|NCT02650830|"~     The goal of this work is to critically test the hypothesis that there exists a different~     profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with~     normal controls. Through confirmation of different profile of BAs in T2DM, investigator will~     suggest modulation of specific bile acids as a new possible treatment target in patients~     with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM~     before hyperglycemia.~      In addition, investigator will evaluate the association between each BA species and serum~     total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations~     to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration~     in serum. Investigatr also evaluates the correlation between each BA species and metabolic~     profiles and oxidative stress marker to find possible roles of each BA component in glucose~     metabolism.~   "
31039|NCT02650817|"~     The purpose of this study is to visualize and quantify ER-binding sites during treatment~     with RAD1901~   "
31040|NCT02650804|"~     This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and~     effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as~     a monotherapy or in combination with gemcitabine in advanced pancreatic cancer patients as~     2nd / 3rd line therapy. The study will enroll up to 50 patients in the US and Europe.~   "
31041|NCT02650791|"~     It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with~     therapeutic platelet transfusions is safe and effective compared to prophylactic platelet~     transfusions in patients undergoing an autologous hematopoietic stem cell transplantation~     (who are at risk for bleeding).~   "
31042|NCT02650778|"~     Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked~     to participate in a automated volume breast ultrasound scanner. The study evaluates~     prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when~     BIRADS category 3 lesions are given a 1 year follow-up recommendation.~   "
31043|NCT02650765|"~     A prospective validation study of the Scandinavian guidelines for initial management of~     minimal, mild and moderate head injuries in adults. Enrolling a consecutive sample of 1000~     adult head injury patients from the emergency department of the Tampere University Hospital~     (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from~     every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome~     assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6~     months, 1 year, and 2 years.~   "
31044|NCT02650752|"~     The purpose of this study is to see if capecitabine can be taken safely with different doses~     of lapatinib in patients with HER-2 positive breast cancer involving brain (brain~     metastases) and/or in spinal fluid (leptomeningeal disease).~   "
31045|NCT02650739|"~     The efficacy of macular hole (MH) surgery with the halting of prone positioning by~     monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images~     was compared with the surgery by the surgeon's decision. The macular hole closure and visual~     outcome were compared.~   "
31046|NCT02650726|"~     HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a~     water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO)~     bioavailability and decreasing oxidative stress. This study was designed to evaluate whether~     anthocyanin supplementation might improve cardiovascular function in diabetic patients.~   "
31047|NCT02650713|"~     This is an open-label, multi-center, dose escalation and expansion Phase IB clinical study~     of RO6958688 in combination with atezolizumab.~   "
31070|NCT02650414|"~     This is a single center, single arm, open-label pilot study to determine the feasibility and~     safety of a single dose administered as spilt fractions of autologous T cells expressing~     CD22 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory~     domains (referred to as CART22 cells) in pediatric patients with relapsed or refractory~     B-cell acute lymphoblastic leukemia.~   "
33889|NCT02613481|"~     This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid~     (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will~     receive Sculptra™.~   "
31048|NCT02650700|"~     Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced~     thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy~     of cancer.~      At present, although platelet transfusion is the gold standard to treat severe CIT, its~     clinical application is limited due to many disadvantages, such as short time for storage,~     not easy to save, the risk of infection and immunological diseases. What's more, other~     cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to~     explore a new therapeutic method to treat CIT.~      Researches show that spleen resection could improve the count of PLT. In this clinical~     trial, we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC,~     simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence~     of severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery~     time from bone marrow suppression and progression free survival, and the exploring index is~     the immulogical status.~   "
31049|NCT02650687|"~     This study will recruit surgical patients more than 65 years old. Patients who participate~     will wear a sticker on their forehead during surgery which monitors their brain waves~     (electroencephalogram, EEG) and participate in memory testing before and after surgery.~     Brain wave patterns will be compared between patients who have problems with memory and~     thinking after surgery and those who do not. The hypothesis is that there will be~     characteristic brain wave patients for who will go on to have problems with memory and~     thinking after surgery.~   "
31050|NCT02650674|"~     This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five~     Cereal Products in two different ethnic groups.~   "
31051|NCT02650661|"~     The purpose of this study is to evaluate the efficacy of the Smart Management Strategy for~     Health (SMASH) program, which is designed to help cancer patients overcome their cancer~     crisis proactively and grow positively.~   "
31052|NCT02650648|"~     This is a phase I study. The purpose of this study is to see if it is safe and feasible to~     give the participant cyclophosphamide (a type of chemotherapy), natural killer (NK) cells,~     and an antibody called Hu3F8 as a treatment for neuroblastoma. NK cells are a type of white~     blood cell.~      Funding Source- FDA OOPD~   "
31053|NCT02650635|"~     This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in~     treating patients with a solid tumor that has spread from the primary site (place where it~     started) to other places in the body (metastatic), progressed for a long time (persistent),~     come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist~     VTX-2337 may stimulate the immune system in different ways and stop tumor cells from~     growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving TLR8 Agonist VTX-2337 together with~     cyclophosphamide may be a better treatment for solid tumors.~   "
31054|NCT02650622|"~     This is a prospective, non-randomized, non-blinded observational study. The overarching goal~     is to discover new disease-associated genes in children, while establishing a specific focus~     on disorders where molecular characterization is most likely to lead to novel therapies.~     This study will merge detailed phenotypic characterization of patients presenting to the~     Pediatric Genetics and Metabolism Division in the Department of Pediatrics/Children's~     Medical Center at Dallas and collaborating clinics with Next-Generation sequencing~     techniques to identify disease-producing mutations. The primary objective of the study is to~     identify novel pathogenic mutations in children with rare Mendelian disorders. A secondary~     objective of the study is to establish normative ranges of a large number of metabolites~     from healthy newborns and older children.~   "
31055|NCT02650609|"~     Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold~     standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural~     hematoma involves numerous inflammatory processes which could be inhibited by steroids.~   "
31056|NCT02650596|"~     The investigators planned to evaluate the effects of liraglutide on left ventricular~     function in chronic heart failure patients with type 2 diabetes.~   "
31057|NCT02650583|"~     This pilot clinical trial studies the use of the Enhancing Connections Program in improving~     communication between patients with incurable cancer and their children. The Enhancing~     Connections Program is an educational program that may provide patients with new~     competencies to improve communication with their children and help them to cope with their~     parent's incurable cancer.~   "
31058|NCT02650570|"~     The purpose of this study is to determine whether skeletal muscle mitochondrial function is~     altered in patients with head and neck cancer compared to healthy controls.~   "
31059|NCT02650557|"~     The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in~     Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to~     P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary~     arteries.~   "
31069|NCT02650427|"~     Boosting of tumor cell killing by cytotoxic lymphocytes may be a promising means to enhance~     anti-tumor immunity. Prior studies demonstrated that tumor infiltration by cytotoxic~     lymphocytes correlates with control of tumor growth and is associated with an improved~     prognosis in cancer patients. Trafficking of activated lymphocytes is a tightly regulated~     mechanism and the specific nature of the chemokine milieu is a crucial determinant for~     permitting T cell entry into the tumor microenvironment. CXCL10 is an interferon-inducible~     chemokine particularly important for the recruitment of activated T, and it has been shown~     to enhance anti-tumor responses through its action on cytotoxic T cells (e.g., glioblastoma,~     colorectal adenocarcinoma and lung carcinoma). Additionally, roles for CXCL10 as an~     anti-tumor effector include its ability to chemo-attract NK cells into sites of~     inflammation, and its ability to inhibit development of new vasculature and induce the~     regression of newly formed vessels. Adding a layer of complexity, the function of CXCL10 can~     be regulated by dipeptidylpeptidase IV (DPPIV), leading to the formation of a dominant~     negative, antagonist form of the chemokine. This was initially demonstrated in vitro, and~     recent work has provided convincing in vivo evidence that antagonist forms of CXCL10~     regulate lymphocyte trafficking. The main goal of this protocol is to evaluate the tolerance~     of sitagliptin treatment in HCC patients, and secondary DPPIV inhibitors as a strategy for~     protecting CXCL10 chemokine agonist activity as a means to enhance tumor regression.~   "
31060|NCT02650544|"~     This is a phase II, placebo-controlled, randomized, double-blinded clinical trial. Study~     objective is to assess the efficacy and safety of mirtazapine in advanced NSCLC patients~     with malignant tumor related depression. Study hypothesis is that advanced NSCLC diagnosed~     with depression undertaking palliative chemotherapy with mirtazapine treatment for 8 weeks~     will have remarkable improvement in depression compared to baseline. Eligible advanced NSCLC~     Patients with PHQ-9 score ≥ 8, and undertaking palliative chemotherapy will be enrolled into~     this study. patients will be stratified (gender, age, Numerical Rating Scale score for~     cancer pain 0-3/4-6/7-10) randomized (1:1) into mirtazapine or placebo treatment. Patients~     in mirtazapine arm will be orally administered with mirtazapine 15mg, QD, consecutive~     medication for 8 weeks; along with palliative chemotherapy regimen decided by investigators.~     Patients in placebo arm will be orally administered with placebo 15mg, QD, consecutive~     medication for 8 weeks; along with palliative chemotherapy regimen decided by investigators.~     During the treatment, Patient health questionnaire (PHQ-9), Hamilton Depression Scale~     (HAMD-17) and European Organization for Research on Treatment of Cancer (EORTC) quality of~     life questionnaire-C30 (QLQ-C30) questionnaires will be collected at baseline, 3 weeks (d22)~     and 8 weeks (d57), or treatment discontinuation date due to depression deteriorated or~     suicidal tendency and behavior. Follow-up will last up to 4 weeks after treatment end with~     depression assessment (questionnaires every 2 weeks). Study endpoints: primary endpoint is~     the anti-depression efficacy (response rate). Response defined as the PHQ-9 or HAMD-17~     questionnaire score decrease ≥ 50% compared with baseline level.~   "
31061|NCT02650531|"~     A prospective observational multicenter study aiming to describe incidence, and identify~     predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI)~     after stroke~   "
31062|NCT02650518|"~     Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe~     and effective as a long course of antibiotic therapy for the treatment of~     catheter-associated urinary tract infections.~   "
31063|NCT02650505|"~     This is a randomized, single-center, controlled, within-subject comparison study assessing~     the sensitization potential of the investigational product, LEO 43204 gel under open~     conditions in healthy volunteers.~      LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of~     the back. Evaluation of dermal reactions at the application sites will be assessed~     clinically using a visual scale that rates the degree of erythema, edema and other signs of~     cutaneous irritation.~      Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will~     enter the Challenge Phase, which consists of one 48-hour application to a naive site on the~     opposite side of the back. Observations at the naive site during Challenge and the patterns~     of reactivity during the Induction Phase will provide a basis for an interpretation of~     contact sensitization.~      A total of 10 applications will be made over a period of approximately 6-8 weeks.~   "
31064|NCT02650492|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has~     previously been characterized in breast cancer patients after receiving imILT treatment ,~     and presumed abscopal effects induced by imILT have also been described in a malignant~     melanoma patient.~      The purpose of this trial is to investigate the functionality and safety of the imILT~     treatment method in patients diagnosed with malignant melanoma. The inflammatory process,~     following on the treatment, will also be described in order to provide a more in depth~     knowledge of the treatment for this indication. The purpose is also to evaluate efficiency~     when it comes to local tumor destruction as well as understanding of the subsequent~     immunological effects. Since immunologically based treatment of malignant melanoma is under~     intense review with so called immune checkpoint inhibitors this trial will also provide~     valuable information on how imILT, in the future, could be combined with these new and, for~     some patients, very effective treatment regimens.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma . Treatment of breast cancer patients caused an increase of cytotoxic~     T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor~     border. Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Five malignant melanoma~     patients stage III - IV will be treated in this trial, which is estimated to be carried out~     during a time period of 12 months.~   "
31065|NCT02650479|"~     Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study~     Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male~     and Female Volunteers~   "
31066|NCT02650466|"~     The purpose of this study is to determine if the Nanopulse System can be used to clear~     common wart lesions on the skin. The Nanopulse System uses a series of low energy, high~     voltage pulses, each one several billionths of a second in duration, to effectively kill the~     target tissue contained within the applicator tip electrodes with minimal damage to~     surrounding tissue. Efficacy and patient outcomes are expected to equal or surpass current~     treatment modalities in terms of increased ease of use, faster patient healing and minimal~     scarring with fewer complications resulting from treatment.~      The device emits significantly less energy than existing electro-surgery or electro-cautery~     equipment and is believed to be similar to laser therapy treatment of warts. Trained~     clinicians can usually diagnose warts based by their appearance and location . Non-genital~     warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common~     warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and~     feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any~     immune deficiencies are low risk and are the focus of this study.Based upon the preclinical~     profile of the Nanopulse device, particularly its safety profile and its effect on~     transformed cells, it is hypothesized that application of pulses from the Nanopulse System ,~     will result in complete clinical clearance of Common Wart lesions with minimal scarring.~   "
31067|NCT02650453|"~     Ongoing registration of deep venous obstructive disease patients treated by means of~     percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy~     (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or~     arteriovenous fistula creation.~   "
31068|NCT02650440|"~     The objective of this study is to compare the effects of novel versus conventional locomotor~     training using a robotic gait orthosis (LT-RGO) after stroke. The novel LT-RGO protocol~     imposes progressive decrease of speed and guidance force as compared with the conventional~     protocol which is the progressive increase of LT-RGO speed with progressive decrease of~     guidance force. The hypothesis is that the novel LT-RGO protocol, by establishing a~     progressive decrease in gait velocity and guidance force, may facilitate greater motor~     recovery compared to the use of a conventional protocol.~   "
31071|NCT02650401|"~     This is a 5-part, open-label, Phase 1/1b multicenter, dose escalation study in pediatric~     patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4)~     non-neuroblastoma, extracranial solid tumors with NTRK1/2/3, ROS1 or ALK gene~     rearrangements; and 5) patients who are otherwise eligible but unable to swallow capsules.~     The study is designed to explore the safety, maximum tolerated dose (MTD) or recommended~     Phase 2 dose (RP2D), pharmacokinetics, and antitumor activity of entrectinib.~   "
31072|NCT02650388|"~     Aortic stenosis (AS) is the most common valve disease among the adult population, in the~     majority of the cases it only requires treatment in advanced age. Transcatheter aortic valve~     implantation (TAVI) has become available as an alternative treatment for very high risk or~     even inoperative patients who are suffering from symptomatic aortic stenosis. Until now it~     has been learnt that there are group of patients who are in a very bad condition and who are~     so frail that they do not benefit from TAVI. These patients have worse survival rate and~     more importantly poor quality of life in spite of a successful procedure. Cardiac surgery~     risk scores like Society of Thoracic surgery score (STS) and EUROSCORE are less accurate in~     aging high risk people. In elderly it is principal to make differentiation between utility~     and futility. On the other hand, beside frailty status the main barrier to TAVI is the risk~     of neurological impairment. Neurological injury and impairment in TAVI can occur as~     cerebrovascular event (CVE) and/or neurocognitive dysfunction. The two neurocognitive~     dysfunctions - post-operative delirium (POD) and post-operative cognitive dysfunction~     (POCD). Most cases remain undetected although clinically could be apparent or silent. The~     neurological injury can be observed and/or detected by neuroimaging techniques and cognitive~     trajectories. A well established and validated frailty score based on relatively simple and~     feasible tests could help in our everyday practice to evaluate the prognosis of elderly~     people undergoing TAVI and to determine those patients who really benefit from the~     procedure.~   "
31073|NCT02650375|"~     This is an open-label, multicenter study designed to assess the safety, tolerability,~     preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with~     advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous~     NSCLC. Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID)~     until disease progression or unacceptable toxicity occurred. The study will determine~     whether MET gene mutation, amplification, as well as MET protein overexpression in tumor~     tissue correlate with treatment efficacy and clinical outcome. The potential PD biomarker~     for Metatinib will also be explored.~   "
31074|NCT02650362|"~     This study is an interventional prospective observatory single center trial, investigating~     the supraspinal effects of long term paresthesia-free high frequency SCS in FBSS patients~     with back and leg pain completed with resting state functional magnetic resonance (rs fMRI)~     and voxel-based magnetic resonance morphometry (VBM).~   "
31075|NCT02650349|"~     This study is an interventional prospective observatory single center trial, investigating~     the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high~     density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed~     with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic~     resonance morphometry (VBM).~   "
31076|NCT02650336|"~     Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated~     lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive~     results. The investigators explored the association between plasma aging biomakers such as~     sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary~     intervention (PCI) with contrast injection.~   "
31077|NCT02650323|"~     This registry aims to collect data related to management of patients affected by acute~     coronary syndromes and hospitalized in the Campania Region of Italy~   "
31078|NCT02650310|"~     The embryo transfer implies transportation from the incubator where they have been at 37 °~     C, to the transfer catheter inside a laminar flow hood whose working surface is also~     maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a~     temperature drop, and consequently thermal stress occurs, which may compromise its future~     viability.~      The aim of this study is to assess the possible improvement in the clinical results when the~     embryos are transported in a stable device to avoid the drop in temperature throughout the~     transfer process.~      With the use of this thermosetting device heated to 37 ° C, researchers expect a 15%~     increase in pregnancy rates.~   "
31079|NCT02650297|"~     Patients with lymphedema may experience pain and body image issues. This study investigates~     the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in~     patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer~     related lymphedema participated. All patients completed the body image and relationships~     scale. Researchers divided the participants randomly into an intervention (n=21) or control~     group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four~     weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed~     daily without compression pump for four weeks by patients at home. At the end of each phase,~     both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.~   "
31080|NCT02650284|"~     A prospective, randomised controlled trial evaluating Total Knee Replacement with the~     Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement~     with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm~     assisted surgery system, Mako.~   "
31081|NCT02650271|"~     This study aims to compare the effect of antiviral therapy with entecavir and lamivudine for~     hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included~     patients will randomly divide into two groups.~   "
31082|NCT02650258|"~     The purpose of this study is to determine and link cadence (the number of steps taken in a~     minute) to the intensity of physical activity (e.g. low-, moderate- and vigorous-intensity)~     in adults (21-85 years old). The investigators anticipate that cadence will be a good~     indicator of exercise intensity. Identifying how cadence relates to activity intensity will~     allow for physical activity guidelines to be communicated to the public in a manner that is~     more accessible to the lay person.~   "
31083|NCT02650245|"~     The investigators specific aim is to evaluate the changes in breath ammonia in comparison to~     blood ammonia and other physiologic markers after a moderate oral protein challenge in~     healthy subjects and subjects with liver cirrhosis.~   "
31084|NCT02650232|"~     To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for~     measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a~     useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the~     baroreflex. A good correlation for measuring the baroreflex sensitivity between the system~     SOMNOtouch and digital photoplethysmography as a reference method is expected but should~     be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the~     spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects~     and in subjects with heart failure. We will also evaluate the feasibility of measuring the~     baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity~     of the baroreflex sensitivity between day and night, the reproducibility of orthostatic~     tolerance test.~   "
31085|NCT02650219|"~     Hypergammaglobulinaemia is frequently observed in type 1 Gaucher disease (GD1), being either~     polyclonal or monoclonal gammopathies. Polyclonal hypergammaglobulinemia may be related to~     the presence of autoantibodies. The clinical significance of such antibodies is questioned~     in Gaucher disease (GD), as some cases of immunologic thrombocytopenia and autoimmune~     hemolytic anemia have also been reported.~      Objectives:~      To evaluate the prevalence of autoantibodies and autoimmune diseases in GD1 patients, we~     conducted a multicenter national study. The investigators investigated whether there was a~     link between splenectomy, genotype, therapeutic options and the presence of these~     autoantibodies.They also investigated whether there was a correlation with some clinical~     manifestations of GD1~   "
31086|NCT02650206|"~     The objective of this study is to test the hypothesis that liraglutide (commonly known as~     Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and~     blood, thereby reducing localized and systemic inflammation which are risk factors for~     cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks~     of treatment during which weight will remain stable, and again after 12 weeks, during which~     liraglutide-related weight loss occurs.~   "
31087|NCT02650193|"~     This is a study of how one or more injections of HSP-130 under the skin effect the white~     blood cell counts and drug levels in women with breast cancer that has not spread to distant~     sites in the body (non-metastatic). This will be studied in women before breast surgery or~     while receiving chemotherapy. Safety will also be studied.~      Additionally, the purpose of this study is to evaluate the effects and safety of single and~     multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will~     determine the dose to move forward for future clinical trials.~   "
31088|NCT02650180|"~     The Soberlink Cellular device, in its original packaging, along with the QuickStart guide~     will be provided to the end user in a simulated home use environment or by Rx in clinic. The~     patient labeling will be in the format intended for distribution.~      Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink~     Cellular device while an additional ten (10) Rx subjects will be provided instruction for~     use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten~     (10) simulated home use subjects will be provided instruction for use for the Soberlink~     Cellular device while an additional ten (10) simulated home use subjects will be provided~     instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal.~     All subjects will be provided with a post-test questionnaire on how to operate the device.~      The post-test questionnaire will collect information regarding device use. The device's use~     will be compared with identified risks to determine if the percentage of failures is within~     the study protocol success criteria. Additionally, measurable usability criteria for~     specific, critical steps will be evaluated.~   "
31089|NCT02650167|"~     Colostrum is the first milk secreted by the mother when the tight junctions of mammary~     epithelium open, allowing the cellular transport of a multitude of components and~     immunological protective derivatives of the maternal circulation to the milk, and especially~     immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind~     this work is that the oro pharyngeal administration of colostrum early in preterm infants~     could help deliver an oral immunotherapy even before the installation of enteral nutrition,~     through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract.~     This practice would improve the digestive tolerance and the establishment of enteral~     feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection~     against subsequent infections. Finally, there could be an improvement in the secondary~     immune tolerance with a decrease in the occurrence of allergic phenomena.~   "
31090|NCT02650154|"~     In the emergency department (ED), ketamine is a popular anesthetic agent during sedation of~     children for painful and other short procedures. Sedation for procedures is more commonly~     used in children than adults, to achieve motion control and cooperation. In children,~     ketamine offers an ideal choice due to the fact that it is short acting, a highly effective~     sedative, and preserves cardio-respiratory stability. In the United States, more than one~     million children per year up to four years of age undergo short procedures requiring~     anesthestic agents, including ketamine. However, there is mounting concern from animal~     studies and retrospective human research regarding the safety of ketamine when administered~     to infants and young children with respect to its potential toxic effects on the developing~     . Conversely, ketamine has also been suggested as a neuroprotective agent. Prompt~     investigation and resolution of this issue is urgently required.~   "
31091|NCT02650141|"~     Due to various complex factors, the incidence of precocious puberty is increasing rapidly.~     It severely threatens physical and mental health of children. It's urgent to explore~     effective ways to control the disease.~   "
31092|NCT02650128|"~     Prospective, multi-center, single arm study designed to evaluate the safety and performance~     of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary~     arteries for the purpose of enhancing the placement of stents and reducing the ultimate~     residual stenosis. Patients will be followed through discharge and at 30 and 180 days.~   "
31122|NCT02649725|"~     The purpose of this study is to determine whether there is positive (beneficial) impact of~     expensive cytotoxic agents on the cancer patients. It is a questionnaire based study that~     will be filled by the cancer patients without obligations.~   "
31123|NCT02649712|"~     The purpose of this study is to compare the clinical effectiveness and long-term outcomes~     between patients with malignant hilar biliary obstruction who are treated by unilateral or~     bilateral stenting.~   "
31093|NCT02650115|"~     Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic~     Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).~      Because of the importance of the current global obesity, NAFLD has become very common and it~     is estimated that its prevalence in the general population reaches 20-30%.~      NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease)~     includes a broad spectrum of liver damage, ranging from simple steatosis isolated~     (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high~     accumulation of extracellular components in the functional liver tissue) and finally~     cirrhosis and its complications.~      Choline deficiency (essential nutrient generally classified as Class B vitamins) has been~     associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the~     body depends in particular on food intake and degradation of choline by the intestinal~     microbiota.~      NAFLD and ALD are complex pathologies resulting from the interaction of environmental /~     nutritional factors and a genetic background. It therefore appears now necessary to study~     the influence of the relationship between genetic predisposition, environmental factors, and~     gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and~     ALD.~      If the interaction of these three elements (the host genetics - environmental factors - and~     intestinal microbiota metabolic choline) has an influence on the severity of the lesions of~     NAFLD and ALD direct application may be of bring a food supplement choline in patients at~     risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase),~     postmenopausal women, microbiota profile for increased degradation of dietary choline) to~     restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD~     and progression to cirrhosis.~   "
31094|NCT02650102|"~     The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases,~     including schizophrenia (SZ). The previous work has indicated a strong genetic association~     between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few~     reports have focused on the expression level of the miR-30 family (miR-30s) and its networks~     of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the~     investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI~     (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The~     investigator then selected several candidate miR-30s and key regulators for further~     validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in~     an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which~     were followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated~     the correlation between the change in gene expression and the improvement of symptoms.~   "
31095|NCT02650089|"~     Both work activity and reduced nocturnal dipping of blood pressure are related to increased~     cardiovascular risk. The aim of the present study was to assess the hemodynamic and~     autonomic responses of university professors during teaching and sleeping times after~     different resistance exercise intensities. Ten normotensive professors (33.6±3.4 years,~     82.4±12.4 kg; 177.0±7.5 cm) randomly underwent control and resistance exercise before~     initiating their daily activities. Resistance exercise consisted of a circuit training~     lasting 40min at 40% and 80% of one repetition maximum test. Systolic blood pressure and~     diastolic blood pressure as well as heart rate variability indicators in the time and~     frequency domains (Low Frequency, High Frequency, Low Frequency:High Frequency ratio) were~     evaluated on resting and 24 hours after the sessions. The average day-time, night-time and~     nocturnal blood pressure fall of systolic blood pressure and diastolic blood pressure were~     calculated.~   "
31096|NCT02650076|"~     The primary objective is to confirm the target receptor occupancy of SK-1405 and to~     correlate receptor occupancy with SK-1405 dose and plasma concentration.~      The secondary objective is to assess the safety and tolerability of SK-1405 in healthy,~     Caucasian, male subjects.~   "
31097|NCT02650063|"~     The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117~     ophthalmic solution (one drop once daily for 7 days) in healthy male adults.~   "
31098|NCT02650050|"~     Diabetes is a major cause of blindness in adults in the developed countries. The retinal~     damages associated with diabetes lead to gradual loss of vision, which is accentuated when~     the macula is affected. This results in macular edema.~      Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and~     are the first line treatment of macular edema.~      Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid~     photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the~     pigment epithelium, it would not cause the side effects of conventional photocoagulation.~     Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective~     treatment with a minimum injection number and without epithelial lesions.~      The main objective of this study is to show that the subthreshold micropulsed laser~     photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce~     the number of anti-VEGF injections during the first year of treatment.~      In this randomized, double blind study, eligible patients will be randomized between a~     micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.~   "
31099|NCT02650037|"~     Anesthesia-induced atelectasis persist in the postoperative period but are not usually~     diagnosed because imaging techniques are required. The aim of the study is to determine~     whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that~     we defined as the Air Test, was able to diagnose atelectasis in the postoperative period~     after a general anesthesia.~   "
31100|NCT02650024|"~     This partially blinded placebo-controlled trial will determine the impact of curing~     Hepatitis C Virus (HCV) with an oral direct-acting antiviral (DAA), ledipasvir and~     sofosbuvir in a single pill, on central nervous system (CNS) outcomes in mono- or Human~     Immunodeficiency Virus (HIV) co-infected individuals.~   "
31101|NCT02650011|"~     Chronic liver disease including liver cirrhosis is still associated with high mortality,~     although advancement of medical management and transplantation. Acute-on-chronic liver~     failure (ACLF) refers to condition of previously stable chronic liver disease with~     occurrence of an acute insult resulting in rapid deterioration of liver function and~     subsequent decompensation. This condition is different from liver cirrhosis (chronic hepatic~     decompensation) in terms of having more chance of recovery with management before acute~     deterioration, although it shows high short-term mortality. Thus, earlier recognition and~     intensive management are important for this condition. However, the definition or diagnostic~     criteria is unclear and the natural course of this condition is not definitely investigated.~     The aim of this study is to establish the natural course of ACLF in Korean patients.~   "
31124|NCT02649699|"~     The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition~     and processing techniques on primary brain tumor patients. The objectives are to improve~     image-guided radiation therapy (IGRT) planning (first part of the study) and treatment~     monitoring (second part).~   "
33890|NCT02613468|"~     The objective of this study was the evaluation of periodontal condition in pregnant women~     and the effect of the treatment of periodontal disease upon low birth weight.~   "
31102|NCT02649998|"~     Background:~      Acute decompensated heart failure (ADHF) is a common and potentially fatal cause of acute~     respiratory distress that requires immediate treatment in emergency department. The~     mortality rates are as high as 20% after discharge. Currently, furosemide is the most~     commonly used medicine in emergency department for ADHF. Although nitrate was proved to~     generate similar effect when compared to furosemide, less than 30% of patients received~     nitrates. This practice happens not only in Hong Kong, but also all around the world.~     Moreover, there is limited evidence to support a difference in ADHF patients receiving~     intravenous nitrate vasodilator therapy or alternative interventions.~      The aims of the study are:~        1. To monitor the changes in concentration of cardiac biomarkers, VAS dyspnoea score and~          cardiac output before and after treatment of furosemide, isosorbide dinitrate or both.~        2. To investigate whether the changes in concentration of cardiac biomarkers, VAS dyspnoea~          score and cardiac output before and after treatment is associated with the change in~          length of hospital stay.~        3. To investigate whether combination treatment with intravenous furosemide and isosorbide~          dinitrate in patients with HF reduces VAS dyspnoea score, in-hospital mortality, length~          of hospital stay and number of readmission to a higher extend than do either medication~          alone.~        4. To evaluate the prognostic values of novel cardiac biomarkers on 7-day, 14-day, 30-day~          and 6-month mortality and readmission.~      Design:~      This single-blinded randomized controlled study will be conducted in the Prince of Wales~     Hospital in Hong Kong.~      Setting and Subjects:~      Patients with dyspnoea will be screened and recruited from adult patients attending the~     emergency department at the Prince of Wales Hospital.~      Interventions:~      Patients with acute decompensated heart failure will be randomly treated with intravenous~     furosemide, isosorbide dinitrate or both. Level of dyspnoea, multi-biomarker and~     haemodynamic parameters will be measured before and after treatment.~      Outcomes:~      The primary outcome is the change in VAS dyspnoea score after treatment of furosemide,~     isosorbide dinitrate or both. The secondary outcomes are the changes in concentration of~     biomarkers and cardiac output, the number of in-hospital mortality, length of hospital stay,~     7-day and 30-day and 6-month mortality and readmission.~   "
31103|NCT02649985|"~     The specific aims of the study are:~      Primary: To determine the presence and regional distribution of microglial activation, as~     assessed by Fluorine-18 (18F) labeled Peripheral Benzodiazepine Receptor 06 (PBR06) -PET,~     in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive~     Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls~      Secondary:~        1. To assess the relationship between microglial activation and clinical variables~          including disease severity and comorbidities (such as pain, fatigue and/or depression),~          as well as clinical MRI findings (such as lesions and atrophy)~        2. A pilot substudy aims to establish the non-inferiority of [F-18]PBR06 as compared with~          Carbon-11 [C-11] labeled Peripheral Benzodiazepine Receptor 28 (PBR28) PET in~          patients with RRMS.~      Hypothesis: The working hypothesis is that there is microglial activation in multiple~     sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/~     regional distribution of microglial activation is different in Multiple Sclerosis (MS)~     versus AD and correlates with disease severity and comorbidities.~      In addition, the investigators hypothesize that [F-18]PBR06-PET scans will be at least as~     good as [C-11]PBR28-PET scans, the current gold standard.~   "
31104|NCT02649972|"~     The purpose of this study is to find out what effects, good or bad, Cobimetinib has in~     patients with histiocytosis. Cobimetinib is an investigational oral medication that blocks~     MEK1.~   "
31105|NCT02649959|"~     This is a Phase III, open label extension study evaluating the continued safety and efficacy~     of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.~   "
31106|NCT02649933|"~     To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy~     course and materno foetal wellbeing.~   "
31107|NCT02649920|"~     At the moment in France, one delivery on four is induced for a medical indication. In this~     context, the practitioners are exposed to an additional difficulty when the clinical~     examination of the patient reveals a unfavorable cervix because the main drug used for the~     releases cannot be used and the cervix must be previously mature.~      There is a pharmacological method used and estimated in these indications of cervical~     maturation: the dinoprostone (Propess®).~      Other methods using a mechanical process, are under development and of evaluation as it is~     the case of the probe of dilation with double balloon (Cook®).~      The population of the obese women is a population in constant increase in France and~     presenting deliveries to higher risks of maternal and foetal complications. At these~     patients, the medicinal releases seem also more difficult and at greater risks of failures.~      The investigators wish compared the efficiency of the cervical ripening balloon to the~     dinoprostone within the framework of a medical indication in a release with a unfavorable~     cervix in obese pregnant women.~   "
31108|NCT02649907|"~     Investigative trial with aim of~        1. the description of the hormonal and metabolic response to meals containing different~          compositions of macronutrients~        2. the metabolic response to these test meals in dependance of the hepatic and muscular~          insulin sensitivity and abdominal adipose tissue and~        3. effects of a weight loss on the hormonal response to these test meals containing~          different compositions of macronutrients~      Primary endpoint:~      Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin~     response to a nutritive stimulation characterized by different nutritional composition~      Secondary endpoints:~        -  differences of substrate utilization depending on the nutritive composition~        -  effects of different hepatic and muscular insulin sensitivity as well as impact of~          visceral fat mass on the hormonal and metabolic response~        -  effect of weight loss on the hormonal and metabolic response to different test meals~      Study procedure:~      After primary characterization 50 probands (male and female) will receive 3 different test~     meals within a randomised (meal order) controlled trial.~      The three different test meals differ in nutritional composition. During consumption of the~     test meal a characterization of the endogenous hormonal response and appetite behaviour is~     performed.~      A nutritional counselling is performed according to the guidelines of the German Nutrition~     Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal~     administration.~      After analysis of the hormonal response to these 3 different testmeals follows a weight~     reduction period over 3 months. Afterwards reevaluation of the probands (again~     administration of 3 different test meals over a period of 3 weeks) will be performed.~      Principal aim of the study:~      Gain of information leading to the understanding of the hormonal regulation of food intake.~     The individual variability shall be determined with the aim of an identification of patient~     groups which show various intensities of the responses to different macronutrients.~   "
31109|NCT02649894|"~     The purpose of this study is to determine whether a new catheter is safe and effective in~     treating malignant pleural effusions compared to approve catheter.~   "
31110|NCT02649881|"~     This study evaluated optimal macrophage diagnosis algorithm through comparative analysis~     between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable~     coronary plaque accompanied with macrophage infiltration.~   "
31125|NCT02649686|"~     The purpose of this study is to find the highest dose of durvalumab that can be tolerated~     without causing very severe side effects when receiving standard treatment and to see what~     effects the study drug has on this type of cancer.~      The researchers doing this study are also interested in looking for markers that will help~     predict which patients are most likely to be helped by durvalumab when receiving standard~     treatment and what effects durvalumab has on this type of cancer.~   "
31126|NCT02649673|"~     This trial will investigate the combination of two anti-cancer agents to treat patients with~     relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US~     FDA approval for treating select gynecological cancers and SCLC. LCL161 is an~     investigational product that has been shown in clinical trials to work together with other~     anti-cancer agents. In this trial, investigators will determine the optimal dose of LCL161~     and topotecan to administer to patients with relapsed/refractory SCLC and ovarian cancers,~     and examine the safety profile of the drug combination.~   "
31111|NCT02649868|"~     Background:~      Liver cancer begins in the cells of the liver. It can be treated with chemotherapy,~     radiation, or even a liver transplant. A less invasive treatment may be able to help some~     people with liver cancer. It is called percutaneous transarterial embolization (TAE). For~     TAE, a material is injected into blood vessels to block the blood flow that is feeding the~     tumor. Researchers want to test a new material for TAE that may shrink tumors and can be~     seen on x-ray and CT images. The embolization may sometimes be combined with thermal~     ablation, or cooking tumors with needles that deliver heat by electricity or microwave.~      Objective:~      To test an embolization material called an LC LUMI beads. To see if it can block blood~     vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT~     images.~      Eligibility:~      Adults 18 85 years old who have been diagnosed with liver cancer~      Design:~      Participants will have routine blood tests, physical exams, and x-rays.~      Participants will be screened with blood tests, physical exam, and medical history. They~     will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a~     contrast drink and a contrast (dye) injected in the veins.~      Participants will be admitted to the clinic. They will repeat the screening tests.~      Participants may have other tests. These may include x-rays, other scans, or ultrasound.~      Participants will be evaluated for general anesthesia.~      They will get counseling about the procedure.~      Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The~     beads contain iodine, which makes them visible by x-ray and by a CT scan machine.~      Participants will have follow-up visits for 12 months. They will have CT scans and/or other~     radiologic tests.~   "
31112|NCT02649855|"~     Background:~      Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate~     area. It can be controlled by lowering the amount of testosterone in the body. This is~     called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system~     kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They~     think this may work better against prostate cancer than ADT alone.~      Objective:~      To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than~     ADT alone.~      Eligibility:~      Men ages 18 years and over with metastatic castrate-sensitive prostate cancer~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Possible CT, MRI, or bone scan: Participants lie in a machine. The machine takes pictures of~     the body.~      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.~      Participants will have 2 optional tumor biopsies during the study.~      Participants will join 1 of 2 groups. Both groups will get:~      ADT~      Docetaxel by vein~      Steroids by mouth or vein before each docetaxel infusion~      PROSTVAC injection~      Both groups first have ADT. One to 4 months after, they have:~      Group A:~      Docetaxel every 3 weeks for 6 cycles~      PROSTVAC 3 weeks after the last infusion~      Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total~      Group B:~      PROSTVAC~      Booster 2 weeks later~      Docetaxel hours later~      Docetaxel and the booster every 3 weeks for 6 cycles~      Participants will have a visit 4-5 weeks after the last treatment. They will then have~     visits every 12 weeks.~      Participants will be followed for up to 15 years. This includes physical exams every year~     for 5 years.~   "
31113|NCT02649842|"~     Post-Approval study to evaluate the rates of severe visual distortions for patients~     requiring correction of approximately 3.00 D to 4.75 D of corneal astigmatism.~   "
31114|NCT02649829|"~     In this phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated~     tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the~     frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to~     provide the first-in-human experimental demonstration that the combination of~     platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe~     and enables the induction of both systemic and in situ mesothelioma-specific immune~     responses in patients with MPM.~   "
31115|NCT02649816|"~     This retrospective cohort study assessed sealant clinical success applied to pit and fissure~     by dental undergraduate students at Piracicaba Dental School - Brazil.~   "
31116|NCT02649803|"~     The purpose of this study is to learn the pediatric asthma control status under community~     management model. To learn the differences of pediatric asthma control status when subjects~     assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment~     adherence and the frequency of asthma attack under community management model.~   "
31117|NCT02649790|"~     This is a first-in-human, multi-center, open-label clinical study with separate dose~     escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety,~     tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients~     with relapsed/refractory MM.~   "
31118|NCT02649777|"~     The role of oxidative stress in disease pathology is increasingly recognized. At present,~     the development of biomarkers of this state is in its infancy and the availability of~     clinically validated assays is lacking. This study will better determine normal values for~     specific biomarkers of oxidative stress. It will also investigate normal values of taurine,~     a natural occurring oxidative stress protectant. A primary and specific application of this~     data is for the evaluation of oxidative stress, levels of the natural protectant taurine,~     and of associated inflammation in the context of cystathionine β-synthase~     (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the~     Impact of Taurine).~   "
31119|NCT02649764|"~     The goal of this clinical research study is to study the safety of LY2606368 when given in~     combination with fludarabine and cytarabine. The effectiveness of the study drug combination~     when given to patients with relapsed or refractory AML or HRMDS will also be studied.~   "
31120|NCT02649751|"~     This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled~     study.~      The aim of this study is to assess the safety of increasing doses of roscovitine~     administered orally for 4 cycles of 4 consecutive days (treatment on) separated by a 3~     days treatment free period (treatment off) in adult CF subjects with Cystic Fibrosis~     carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and~     chronically infected with Pseudomonas aeruginosa.~      This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.~   "
31121|NCT02649738|"~     This study will evaluate the outcomes of placing preserved corneal tissue within the~     keratoconic cornea in order to enhance thickness, stability, and optical conformation.~   "
31127|NCT02649660|"~     This study aims to evaluate whether platelets are biochemically and functionally altered in~     Fabry disease (FD) and therefore possibly implicated in FD manifestations such as~     cerebrovascular events. To test this hypothesis the investigators aim to compare platelet~     and plasma lipid profiles, as well as platelet function and coagulation parameters of FD~     patients and healthy controls.~   "
31128|NCT02649647|"~     Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment~     for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of~     bowel dysfunction after sphincter-preserving surgery, for which patients suffer from~     incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative~     chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after~     rectal cancer surgery.~      Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a~     major concern. When conventional surgical procedures would retain part of sigmoid colon that~     has been included in the radiation target, sphincter-preserving surgery with proximally~     extended resection margin could provide an intact proximal colon limb for the anastomosis.~      It is not known yet whether proximally extended resection improves postoperative bowel~     function or anastomotic integrity for patients with rectal cancer after neoadjuvant~     chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and~     without proximally extended resection margin, to observe the postoperative bowel function~     and incidence of anastomotic complication. This study will examine a new surgical strategy,~     which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.~   "
31129|NCT02649634|"~     The purpose of this study is to determine whether adding motivational interviewing (MI) to a~     behavioural weight loss program (BWLP) results in improved weight loss in adults with~     overweight and obesity.~   "
31130|NCT02649621|"~     Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal~     epithelium that are necessary for repair of corneal. About patients with deficient or~     absence of this area has been proposed various treatments such as limbal stem cell~     transplantation.~      This study is a prospective clinical trial to compare the improvement of limbal stem cell~     deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).~   "
31131|NCT02649608|"~     To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and~     metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson`s Disease.~   "
31132|NCT02649595|"~     The aim of this study is to determine the effect of a two week respite program (Red Cross)~     for homeless people just discharged from hospitals in the capital region of Denmark.~      The study is a randomized controlled trial and an economic evaluation. The intervention is a~     2 week stay at a Red Cross respite care center. The intervention is intended for homeless~     people or functional homeless, who has been admitted to hospital and received standard~     medical care and treatment at the hospital. Under normal circumstances the homeless patients~     would be discharged to live on the street and receive care from programs in the~     municipalities. The respite center offers standard nursing care, rest with a place to sleep,~     food and help dealing with social problems such as economy and housing. The respite care~     center is led by a nurse who is represented during daytime from Monday to Friday and besides~     that, volunteers are used as staff.~      The control group is receiving usual care and is discharged to the street and the usual~     communal programs.~      The study examines whether a 2 week stay is cost effective and whether it can improve the~     health related quality of live (HRQoL). The hypothesis is that a respite care stay will~     result in a 25 % reduction in health care costs and increase the HRQoL.~   "
31133|NCT02649582|"~     In this phase I/II trial, the primary objective is to determine overall and progression-free~     survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1)~     messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide~     maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.~   "
31134|NCT02649569|"~     This pilot research trial studies continuous activity monitoring during fractionated~     radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study~     explores the use of fitness trackers to study the activity levels of patients before,~     during, and after radiation therapy and the use of weekly assessments to measure the~     patients' quality of life during radiation therapy. This may allow doctors to see if there~     is any relationship between activity levels, quality of life, treatment interruptions,~     hospitalizations, and clinical outcomes.~   "
31135|NCT02649556|"~     The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco~     Heating System 2.2 (THS 2.2) compared to conventional cigarettes (CC) on the components of~     the smokers' health profile for a prolonged period of 26 weeks, providing additional~     information to the results of the original study ZRHR-ERS-09-US of 26-week exposure~     (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52~     weeks.~   "
31136|NCT02649543|"~     The objective of the study is to compare infection rates between primary, delayed primary~     and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.~   "
31137|NCT02649530|"~     Given that up-regulation of the Wnt pathway has been identified as having a significant role~     in carcinogenesis in advanced head and neck squamous cell carcinoma, the investigator~     believes that inhibition of Porcupine via WNT974 will result in tumor control hence~     improvement in disease free and overall survival in these patients with a tolerable toxicity~     profile. As suggested by pre-clinical models, patients with a tumor harboring a Notch~     receptor (any of the four) loss of function mutation may have a greater response rate to~     treatment with WNT974. The investigator aims to address this question by administration of~     single agent WNT974 and following response radiologically along with close clinical follow~     up to monitor toxicities.~   "
31138|NCT02649517|"~     The purpose of the study is to investigate the clinical and morphological characteristics of~     chronic subclinical inflammation in the myocardium in patients with decompensated heart~     failure with ischemic systolic dysfunction.~   "
31139|NCT02649504|"~     The investigators will attempt to further increase the cure rate of ITP with medical therapy~     by providing maintenance therapy with Mycophenolate mofetil (MMF) to persistent/chronic ITP~     patients after treating them with induction therapy combining rituximab and dexamethasone.~     The investigators will randomly assign patients to MMF versus placebo in order to~     demonstrate safety (e.g., for infectious risk) and efficacy (platelet counts stably~     >50x109/L more than 1 year off therapy).~   "
31140|NCT02649491|"~     Scientists have developed an instrument which works like an electronic nose. It is able to~     sniff smells and separate different smells by their electronic signature. Studies using~     an electronic nose strongly suggest that smelling samples taken from humans (e.g. urine/~     stool/ sweat/ tears) can identify different electronic smell signature from people with~     different diseases and in the future might be a new and easier way to diagnose serious~     conditions at an earlier stage.~      In a very small study, it has been successfully shown that using an electronic nose to sniff~     a stool sample does seem to identify people before they have had any radiotherapy - who will~     go on to get serious bowel side effects of radiotherapy. If this finding is correct, this is~     very important as it would allow the cancer doctors the option to change the way they give~     radiotherapy if they knew that a person was at very high risk of serious side effects from~     the treatment and to start treatment for the side effects at a much earlier stage.~      In this study the investigators want to confirm in a larger study whether the previous~     findings are correct, and to see whether similar results can be obtained by sniffing urine~     rather than stool (that would be much easier for everyone) and identify exactly which part~     of the complicated smell signature is different in the people who will get side effects.~     This may lead for the investigators to able to identify why people are making this specific~     smell and then do something about changing the smell before treatment starts. The likeliest~     cause for the production of a smell which predisposes to side effects is a specific group of~     germs living in the bowel. If these germs can be identified, then there are many possible~     ways of changing these germ populations in advance of radiotherapy.~      Enormous improvements have been made in treating cancer in recent years leading to hugely~     improved survival, however, treatment not infrequently can lead to side effects. Of all the~     possible long term physical side effects of cancer treatment, gastrointestinal (GI) symptoms~     are the most common and can have a great impact on daily activity. It is becoming~     increasingly clear that development of side effects in the bowel is not just related to the~     dose and way the radiotherapy is delivered.~   "
31141|NCT02649478|"~     A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of~     Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder~     Compared with Advair Diskus® 100/50 in Subjects with Asthma~   "
31142|NCT02649465|"~     1. Objectives~        1. Which organ and how does SGLT2 inhibitor alter insulin sensitivity?~        2. How does SGLT2 inhibitor increase glucagon levels and hepatic glucose production?~   "
31143|NCT02649452|"~     Whole body vibration (WBV) can help to improve muscle flexibility by stimulating the~     neuromuscular functions. But there is a dearth in the literature to prove its effectiveness~     in improving the flexibility of the upper limb muscles. Therefore the purpose of the study~     is to determine the effects of vibration on improving upper limb flexibility. This~     experimental research will be conducted by recruiting participants at the age of 19 to 27~     with no histories of injuries on the upper limb. They will be randomly assigned into two~     groups; experimental (with vibration) and control (no vibration) group. The WBV machine will~     be used to provide vibration to the upper extremities by placing both palms on the vibration~     platform. The outcome measure of active chest flexibility and shoulder reach flexibility~     will be performed pre and post vibration.~   "
31144|NCT02649439|"~     Background:~      Some people who have been treated for prostate cancer still have high prostate-specific~     antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration~     sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers~     think the immune system can be taught to fight and kill cancer cells. They think an~     immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type~     of prostate cancer.~      Objective:~      To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting~     surveillance alone.~      Eligibility:~      Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Bone scan~      CT scan, or MRI and PET scan: They lie in a machine that takes pictures of the body.~      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.~      Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will~     have surveillance for 6 months followed by prostvac for 6 months.~      During the prostvac period, participants will get prostvac as a shot under the skin on weeks~     1, 3, and 5, and then monthly for a total of 5 months.~      Participants will have follow-up visits at least every month until they recover from~     prostvac side effects or their cancer worsens. Visits may include repeats of screening~     tests.~      Participants will be followed for up to 15 years. They will have a physical exam every year~     for the first 5 years. They will have phone calls once a year.~   "
31145|NCT02649426|"~     RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO)~     designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation~     System in two distinct populations of hypertensive subjects.~   "
31146|NCT02649413|"~     The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration~     of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for~     steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the~     investigators will adjusted the first steroids does to the response day. Our primary end~     point is : a lower adjusted dose is as good as the fix dose in the first year after~     diagnosis.~   "
31147|NCT02649400|"~     This study assesses the impact of diastolic heart failure on exercise capacity in women who~     have a previous coronary condition. All the participants will go through the same~     evaluation.~   "
31148|NCT02649387|"~     This phase II trial studies the side effects and how well ibrutinib works in treating~     patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce~     a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
31149|NCT02649374|"~     The purpose of this study is to document the gut microbiome in the 1st, 2nd and 3rd~     trimester among pregnant women with gestational diabetes and non diabetic controls.~   "
31150|NCT02649361|"~     To compare the effects and safety of Anlotinib with placebo in patients with esophageal~     squamous cell carcinoma(ESCC).~   "
31151|NCT02649348|"~     A prospective randomised controlled trial to investigate effects of preoperative exercise~     and eliminating abdominal breathing on perioperative outcome in gastric cancer patients with~     metabolic syndrome who will undergoing laparoscopic gastrectomy.~   "
31152|NCT02649335|"~     Cirrhosis is the leading cause of death in India and worldwide and leading causes in~     developed world include alcoholic liver disease, hepatitis C, and more recently,~     non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH). As~     cirrhosis advances, portal hypertension develops, resulting in complications such as~     ascites, hepatic encephalopathy, and variceal hemorrhage.~      Ascites is the most common major complication of cirrhosis, occurring in 50-60% of patients~     within ten years of diagnosis . Development of ascites is an ominous landmark in disease~     progression as 15% of patients with ascites will die within 1 year, and 44% within 5 years.~     Less than 10% patients develop refractory ascites and is associated with a poor prognosis~     with a high mortality, approximately 50% within 6 months and 75% at 1 year with the median~     survival approximately 6 months . Refractory ascites occurs as a result of splanchnic~     vasodilatation and maximal activation of the sympathetic nervous system (SNS) and the renin~     - aldosterone system (RAAS) . The therapeutic options available for these patients are~     serial therapeutic paracentesis, liver transplantation and trans jugular intrahepatic~     portosystemic shunts .The model for end stage liver disease( MELD) score predicts survival~     in patients with cirrhosis . However, other factors in patients with cirrhosis and ascites~     are also associated with poor prognosis, including low mean arterial pressure; low serum~     sodium, low urine sodium, and high Child-Pugh score .~      Variceal bleed is the most dreaded complication of cirrhosis and screening endoscopic is~     recommend in these patients. About 60% of patients with decompensated cirrhosis have varices~     at the time of diagnosis. Majority of these patients will require non selective beta~     blockers (NSBB) as standard of care as primary or secondary prophylaxis in prevention of~     variceal hemorrhage. NSBB reduce portal pressure by decreasing cardiac output and by~     producing splanchnic vasoconstriction.. Endoscopic variceal band ligation (EVL) is another~     modality of treatment of esophageal varices and meta-analysis showed EVL to be associated~     with significantly lower incidence of first variceal hemorrhage without differences in~     mortality compared to NSBB. NSBB also has shown to improve survival in these patients with~     nonhemodynamic effects. Some of the patients may progress to end stage liver disease~     characterized by the development of refractory ascites and other complications.~      Most of the studies of NSBB comparing to EVL for primary/secondary prevention of variceal~     hemorrhage included patients of predominantly child A/B cirrhosis with variable number with~     ascites without any mention of ascites grading and some of trials excluded patient's with~     refractory ascites. These patients with ascites received diuretics and salt restricted diet~     as standard of care. However none of these studies mentioned about control of ascites and~     survival benefit in patients with advanced stage (child B and C) cirrhosis with ascites .In~     recent years the role of NSBB for prevention of variceal hemorrhage in refractory ascites~     patients has been questioned because of the deleterious effect on survival.However the use~     of NSBB in end stage liver disease has shown mixed results and controversial.~      Therefore this study is being planned to know the effects of NSBB in advanced stage liver~     disease patients with ascites and varices in preventing variceal hemorrhage ,effect on~     ascites and survival.~   "
31153|NCT02649322|"~     Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief~     for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional~     anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic~     knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected~     lidocaine prior to regional and general anesthesia.~   "
31154|NCT02649309|"~     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to~     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in~     patient undergoing coronary angioplasty.~   "
31158|NCT02649257|"~     The purpose of this study is to observe the axial IOL rotation after surgery with a capsular~     tension ring (CTR) and a MC6125 AS IOL.~      At the end of surgery the orientation of the IOL is documented with a short video clip via~     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6~     months after surgery. Rotational stability of the IOL is assessed using retroillumination~     images with a method to avoid bias from cyclorotation or head tilt.~   "
31159|NCT02649244|"~     The purpose of this study is to examine the effectiveness of the Family Caregiver Training~     Program for caregivers of people with dementia, using a pretest posttest randomized control~     trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours~     and hence, three modules over the course of one day. Module one will present information on~     communication, eating, and nutrition, module two will focus on transfers and toileting, and~     module three will focus on bathing, grooming, and dressing. The control group will receive~     standard care as relevant to dementia family caregivers including general information on the~     progression of dementia, and helpful resources as suggested by the Alzheimer's Association.~     A convenience sample of 36 family caregivers will be recruited by flyers posted throughout~     local area community boards and Alzheimer's Association media outlets. A repeated measures~     ANOVA will be used to assess the group differences in knowledge and confidence at three time~     points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in~     caregiver burden, depression, quality of life, and occupational performance and satisfaction~     will be assessed 3-months post-intervention.~   "
31160|NCT02649231|"~     96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine~     (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3~     sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3~     and 6 months on a range of psychological and biological variables. Primary endpoints will be~     % days abstinent at 3 and 6 months and relapse rates at 6 months. Secondary endpoints~     include depressive symptoms, craving, quality of life.~   "
31161|NCT02649218|"~     A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every~     4 weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study~     CQGE031C2201~   "
31162|NCT02649205|"~     The purpose of this study is to characterise the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
31163|NCT02649192|"~     Children are particularly vulnerable to respiratory virus infections, especially influenza.~     Vitamin A & D deficiencies are associated with vulnerability to infectious diseases of the~     respiratory tract. The central hypothesis of this protocol is that vitamin supplements will~     enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will~     be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza~     virus vaccine with placebo. Children will be tested for vitamin levels and immune responses~     before and after influenza virus vaccinations to determine if vitamin supplementation~     improves the influenza virus vaccine-induced immune response.~      PRIMARY OBJECTIVE:~        -  To assess the vaccine-induced and total antibody (including IgG and IgA) response after~          influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56~          days in sera~      SECONDARY OBJECTIVE:~        -  To assess the neutralizing response toward influenza virus vaccine in the sera.~   "
31164|NCT02649179|"~     The purpose of this study is to evaluate the effect of pain relief after infusion of~     ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo~     (0.9% normal saline).~   "
31165|NCT02649166|"~     Essential tremor is an incurable, degenerative brain disorder that results in increasingly~     debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25%~     of essential tremor patients were forced to change jobs or take early retirement because of~     tremor. Essential tremor is directly linked to progressive functional impairment, social~     embarrassment, and even depression. The tremor associated with essential tremor is typically~     slow, involves the hands (and sometimes the head and voice), worsens with intentional~     movements, and is insidiously progressive over many years. Deep brain stimulation has~     emerged as a highly effective treatment for intractable, debilitating essential tremor.~     However, since the intention tremor of essential tremor is typically intermittent, and~     commonly absent at rest, the currently available continuous deep brain stimulation may be~     delivering unnecessary current to the brain that increases undesirable side effects such as~     slurred speech and walking difficulty, and hastens the depletion of device batteries,~     necessitating more frequent surgical procedures to replace spent pulse generators. The~     overall objective of this early feasibility study is to provide preliminary data on the~     safety and efficacy of closed-loop deep brain stimulation for intention tremor using novel~     deep brain stimulation devices capable of continuously sensing brain activity and delivering~     therapeutic stimulation only when necessary to suppress tremor.~   "
31166|NCT02649153|"~     Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience~     temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and~     chewing gum can reduce the bowel paralysis after hepatic resection in patients with~     hepatocellular carcinoma. One third of the study population will receive smoked plum, one~     third with chewing gum, and the last will act as empty control.~   "
31167|NCT02649140|"~     Purpose:~      The aim of this present study is to investigate the effect of vinegar consumption on 24-hour~     urinary risk factors associated with calcium oxalate urinary stone formation and blood~     biochemical parameters.~      Methods:~      The investigators will recruit 50 healthy young student volunteers in this study. By simple~     random sampling technique, volunteers will be allocated to two groups (group 1, control~     group; group 2, vinegar group).Each participant in vinegar group drink 15ml vinegar (~     Ninghuafu, Sanxi, China) at noon and evening respectively for a period of four weeks.The end~     point of this study is comparison the outcomes of 24-hour urine and blood biochemical~     parameters between different group and point-in-time.~   "
31629|NCT02643095|"~     This study will be done with subjects who already habitually wear scleral contact lenses.~     The study lens is made with a material that is already widely available and has a new~     design. It will be fit by the investigators and will be assessed and at one week and 1~     month.~   "
31169|NCT02649114|"~     The combination of EDs (ED) and post-traumatic sequelae of childhood trauma leads to~     significant impairment, suffering and represents a public health concern because it is~     frequently associated with role impairment, and is frequently under-treated. Considering the~     severity of these conditions, there is a need to develop more effective treatments that are~     tailored to the specific needs of these patients as no conclusion has been made about the~     treatment of choice. To improve treatment it is critically important to study treatment~     effects and the mechanism of these effects.~   "
31170|NCT02649101|"~     Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty~     patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled~     into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.~   "
31171|NCT02649088|"~     Prospective observational study designed to implement a daily monitoring of microcirculation~     and tissue oxygenation in all critically ill patients admitted to the ICU in the period of~     nine months, in order to assess the prevalence of microvascular perfusion abnormalities and~     their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and~     hemodynamic parameters commonly measured, indices of clinical severity and predictors of~     mortality , therapeutic interventions that are part of routine clinical practice (fluids,~     sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood~     transfusion). The study also includes the evaluation of sublingual microcirculation and~     tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions.~     Within the first 12 hours after admission to ICU and every 24 hours for the duration of~     hospitalization, the following evaluations will be made: -study of sublingual~     microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using~     near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the~     outcome of patients admitted in ICU and microcirculatory parameters.~   "
31172|NCT02649075|"~     The objective of this study is to evaluate the nutritional therapy with SBI (a medical food)~     as compared to placebo in the clinical dietary management of mild to moderate Crohn's~     disease.~   "
31173|NCT02649062|"~     The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid~     homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.~   "
31174|NCT02649049|"~     Patients with NAFLD and matched controls will be asked about their demographic status, and~     their previous year dietary intakes using a validated FFQ.~   "
31175|NCT02649036|"~     Background:~      Inequality in access to healthcare is a challenge internationally. Despite that medical~     emergency calls can be considered as access point to pre-hospital emergency care and~     hospital admission in emergency situations, no data on inequality in access to healthcare~     through emergency calls is reported in the international literature.~      Study aims:~      The aim of this study is two-fold:~        1. to evaluate the association between socio-economic characteristics of citizens and~          first-time emergency call in the Capital Region of Denmark~        2. to evaluate the association between socio-economic characteristics of citizens with an~          emergency call and the priority level of the response provided by the emergency medical~          dispatch center in the Capital Region of Denmark.~      Method: Observational register based study of adult citizens in the Capital Region of~     Denmark. Educational level, household income and employment are used as socioeconomic~     indicators. The unique civil registration number will be used to link data from the~     Emergency Medical Dispatch Center with data from the Civil Registration System, Danish~     registers on personal labor market affiliation, the Danish Populations Education Register,~     the Danish Income Statistics Registry and the national patient registry. Logistic regression~     models will be used for the association between socio economic indicators and first time~     emergency calls and the association between socioeconomic indicators and the priority level~     of the response provided.~   "
31176|NCT02649023|"~     To investigate the incidence of pre- and early postoperative deep venous thrombosis in~     patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk~     factors with special attention to circulating tumor cells.~   "
31177|NCT02649010|"~     The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in~     subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor~     performance in arm in subjects age 14 - 75 years.~   "
31178|NCT02648997|"~     This research study is studying a targeted immunotherapy as a possible treatment for~     Recurrent Meningioma. The name of the study intervention involved in this study is~     Nivolumab.~   "
31179|NCT02648984|"~     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease usually~     develops secondary to chronic volume overload of the pulmonary circulation following left to~     right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to~     increased pulmonary vascular resistance (PVR), leading to right ventricular dysfunction,~     considerable morbidity and even mortality.~      Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease~     already evolved to an advanced stage and treatment is often initiated too late. Our research~     group standardized the technique for the detection of early pulmonary vascular disease by~     bicycle stress echocardiography. The investigators now aim to assess this exercise technique~     in a group of patients with ventricular septal defect.~   "
31180|NCT02648971|"~     This randomized, controlled clinical trial will compare the outcomes of single portal versus~     two portal techniques in patients who have meniscus or articular cartilage pathology. The~     study hypothesis is that patients who undergo single portal arthroscopy will have less pain~     post-operatively, use less pain medication, and have a higher International Knee~     Documentation Committee (IKDC) score at six months and one year compared to patients who~     undergo traditional two portal knee arthroscopy.~   "
31181|NCT02648958|"~     Ischemia reperfusion injury causes the release of free oxygen radicals. The selective~     alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses~     during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine~     on inflammatory responses during ischemia-reperfusion injury in skeletal muscle.~   "
31350|NCT02646761|"~     The purpose of this study is to determine if home-based therapy with monitoring via~     telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients~     undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient~     physical therapy course. Subjects will undergo standard physical therapy or physical therapy~     paired with InterACTION for 10 weeks.~   "
31182|NCT02648945|"~     Anxiety levels among the younger generation especially students have been increasing~     drastically in recent years. This severely affects a student's academics as previous studies~     have shown a strong correlation between high anxiety levels and poor working memory. Working~     memory, also known as short term memory is an important component in studying as it aids in~     holding important information needed to understand following information for a short period~     of time. This concerning phenomenon has drawn the attention of researchers to find solutions~     to this issue where recent studies have found physical exercise to contribute in the~     improvement of cognition which also includes working memory. Hence, the aim of this study is~     to compare the effects of low and high intensity exercises on working memory among students~     with high anxiety levels. Thirty female undergraduate students from UTAR with relatively~     high levels of anxiety will be conveniently sampled using Beck Anxiety Inventory.~     Participants will then be randomly allocated into 2 groups to undergo low and high intensity~     exercise on a treadmill according to Balke's Protocol. 2 memory assessments involving Verbal~     Memory Task will be conducted for each participant before and after the intervention.~   "
31183|NCT02648932|"~     The study seeks to compare time from formal search to hematopoietic cell transplantation~     (HCT) for patients 18 years and older, randomized between haplo-cord search and matched~     unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk~     myelodysplastic syndrome (MDS)~   "
31184|NCT02648919|"~     The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with~     very low risk or low risk prostate cancer~   "
31185|NCT02648906|"~     The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and~     Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer~     patients~   "
31186|NCT02648893|"~     In this study, a multiple food crops basket (containing four either biofortified or~     commercially-available food crops) will be fed to young children in Mumbai, Maharashtra,~     India over a period of nine months to measure growth, cognitive changes, and immune function~     in comparison to children receiving non-biofortified crops.~      Potentially, lactating women (their mothers) will also be included in the study.~   "
31187|NCT02648880|"~     The purpose of this study is to investigate the effects of a preoperative exercise program~     in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs~     have been shown to be effective in other cancer populations, but have not been investigated~     in patients with pancreatic cancer. The outcomes in this study will be changes in physical~     fitness, function, and postoperative outcomes. This investigation is a non-randomized~     control trial, with participants assigned to receive the preoperative exercise intervention~     in addition to standard care, or standard care alone if unable to commit to an exercise~     program for practical reasons. Possible mediators for the effects of exercise on~     postoperative outcomes will also be assessed, including psychological outcomes and markers~     of systemic inflammation. These measures will be assessed in all participants prior to~     program initiation, prior to surgery, and after surgery. Changes in these measures in~     response to exercise will be assessed, as well as the ability of the preoperative measures~     to predict postoperative outcomes.~   "
31188|NCT02648867|"~     This study will assess the ability for continuous electronic feedback to reduce the length~     of second stage labor and improve maternal and fetal outcomes.~   "
31189|NCT02648854|"~     This study is A randomized, open-label, single dose, 2-way crossover study to investigate~     the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male~     volunteers.~   "
31190|NCT02648841|"~     The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients~     with local advanced gastric cancer.~   "
31191|NCT02648828|"~     The purpose of the study is to compare the ability of physicians and a statistical index~     (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical~     deterioration is defined as concern in change in vital signs or patient status requiring a~     call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.~   "
31192|NCT02648815|"~     This study aims to investigate the natural clinical course, diagnostic possibilities and~     treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The~     management of severe acute pancreatitis varies with the severity and depends on the type of~     complication that requires treatment. Although no universally accepted treatment algorithm~     exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage,~     followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated~     to produce superior outcomes to traditional open necrosectomy and may be considered as the~     reference standard intervention for this disorder.~   "
31193|NCT02648802|"~     This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS)~     on pathological cavity margin (CM) status in breast cancer patients. Patients receiving~     standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment~     versus intra-operative CS followed by CM assessment. The primary objective of this study is~     to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate,~     post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time~     and medical costs.~   "
31194|NCT02648789|"~     The purpose of this study is to investigate the correlation between DNA methylation and the~     treatment and recurrence of oral cancer.~   "
31195|NCT02648776|"~     The aims of this study are to (1) examine the medication use patterns of commonly prescribed~     hypnotics and the factors that were associated with the long-term and short-term use~     patterns among the elderly population in Taiwan; (2)investigate the associations of using~     hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as its~     pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and~     humanistic outcomes of using hypnotics and the corresponding contributing factors for the~     elderly in Taiwan.~   "
31196|NCT02648763|"~     The purpose of this study is to evaluate the accuracy of participants imaging versus staging~     procedures. The investigators will consent subjects that are scheduled to undergo staging~     procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy,~     endobronchial ultrasound and laparoscopy) as part of their standard of care.~   "
31365|NCT02646566|"~     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,~     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of~     established PONV, in patients who have had prior PONV prophylaxis.~   "
31198|NCT02648737|"~     Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a~     negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life.~     With this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive~     Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this~     module in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral~     connectivity. Effective CBT treatment of anxiety will provide patients with behavioural and~     anxiety management techniques that can give lasting benefits, not only on anxiety symptoms,~     but potentially also on motor symptoms.~   "
31199|NCT02648724|"~     This is the first study to test Sym015 in humans. The primary purpose of this study is to~     see if Sym015 is safe and effective for patients with advanced solid tumors who do not have~     other available treatment options.~   "
31200|NCT02648711|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule~     1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week~     on / 1 week off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for~     future clinical studies.~   "
31201|NCT02648698|"~     82 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells~     in endometrial biopsy sample identified by immunohistochemical staining using CD138~     antibody, will be recruited. The subjects will be randomly divided into two groups, the~     experimental group will be given antibiotic (Augmentin) treatment, the control group will be~     given placebo. A repeat endometrial biopsy sample will be obtained one month after~     completion of the antibiotic therapy to assess the response to treatment. The cure rate will~     be compared between the two groups~   "
31202|NCT02648685|"~     There was no any China mainland data showing the contribution of BBG and PBG to HbA1c in~     T2DM patients treated with OADs using the CGM method. Therefore this study is aimed to~     investigate the contribution of BBG and PBG to HbA1c in Chinese T2DM patients treated with~     OADs using CGMS. It's expected to generate evidence to support the concept of individualized~     therapy when patients are uncontrolled by OADs.~   "
31203|NCT02648672|"~     This is a randomized double-blind (investigator and subject blinded), placebo controlled~     ascending single dose study to evaluate the safety, tolerability, and pharmacokinetic~     profile of BPN14770 in healthy male and female subjects. Each subject will be randomized to~     receive either a single dose of BPN14770 or placebo.~   "
31204|NCT02648659|"~     This study assessed the effect of tailored eradication therapy according to Clarithromycin~     resistance in Helicobacter pylori patients.~   "
31205|NCT02648646|"~     Purpose: To report the feasibility and to obtain preliminary data on the effects of using an~     enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis~     (OA).~      Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA,~     are at risk for falls, and are 65+ years old.~      Procedures (methods): All participants will receive the 6-month enhanced Otago program. The~     investigators will assemble data: quantifying participant adherence to and safety of the~     intervention, ascertaining retention of participants for 6 months, determining acceptability~     of the program, and other validated measures (e.g., number of falls and fall severity,~     balance measures).~   "
31206|NCT02648633|"~     The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic~     agent nivolumab given in combination with gamma knife therapy and valproate in patients with~     recurrent glioblastoma, a common and lethal type of brain cancer.~   "
31207|NCT02648620|"~     PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and~     functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with~     symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and~     popliteal arteries. The trial will enroll up to 15 subjects.~   "
31208|NCT02648607|"~     Pelvic girdle pain (PGP) during pregnancy occurs in approximately 70% of females and 38% of~     women continue to suffer PGP symptoms beyond 12 weeks following delivery. PGP post- partum~     causes pain during everyday activities that impacts negatively on health related quality of~     life and is associated with significant healthcare and societal costs. These women are often~     referred to physiotherapy, however management is difficult and there is a weak evidence base~     for its management.~      Alongside the provision of advice and information, physiotherapists commonly prescribe~     orthoses such as a rigid belt with the aim of optimising pelvic stability and reducing pain.~     More recently a novel customised Dynamic Elastomeric Fabric Orthosis has been developed as~     an alternative to an 'off the shelf' pelvic belt. No studies have investigated their~     effectiveness in complementing standard physiotherapy advice and management.~      We will undertake a comprehensive systematic review of the literature to critically evaluate~     the evidence base for the conservative management of chronic post-partum PGP. This will~     inform a single case experimental design. Here eight AB single case studies will be~     performed with the point of intervention being randomised between subjects. The use of a~     randomisation test permits subsequent statistical analyses of group effects. Participants'~     pain, activity levels, and quality of life will be evaluated along with subjective changes~     in confidence and urinary incontinence. Adherence to orthosis use will be diarised. Exit~     interviews will assess aspects such as the appropriateness of the outcome measures and~     acceptability of the intervention that will help to inform future clinical trials.~   "
31209|NCT02648594|"~     When patient presents a lung node, there is an important risk that this node was a tumor.~     For patients who have these nodes, the surgery is the best treatment. When the surgery is~     possible, the thoracoscopy may be more advantageous compared to thoracothomy (decrease of~     post surgery pains, decrease of recovery time and decrease of drugs consumption).~     Nevertheless, thoracoscopy needs specific materiels and nécessite un équipement spécifique~     and trained physicians.~      Moreover, this technic needs that nodes was well localized. For this, radiologists use~     CT-guided hook wire localization of these lung nodes before surgery.~      TThe hook wire laying is delicate. It can lead secondaries effects as pneumothorax,~     dislodgement of the hook wire before and after surgery. The success rate of hook wire~     fixation in lung near of the node is primary.~      The main objective of our study is to assess the success rate localization of node in~     surgery piece, that is to verify if the hook wire have allowed to localize the lung node in~     surgery piece.~   "
31630|NCT02643082|"~     Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway~     Volumes and Resistance With Moderate to Severe COPD.~   "
31211|NCT02648568|"~     The aim of the study is to compare the benefit of two cognitive therapies in severe~     sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric,~     double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking~     (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video~     polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a~     medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and~     systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and~     suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to~     the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated~     controls. Randomized patients will receive the therapy on day 1, and be monitored during the~     subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored~     again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires.~     They will also complete the questionnaire by phone on Month 3. The non-randomized controls~     will complete the questionnaire on month 1, with no therapeutical intervention between Day 1~     and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by~     the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the~     N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night~     28 (long term effect), as well as changes in sleep quality and sleepiness scales. A~     comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart~     rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.~   "
31212|NCT02648555|"~     Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated~     activation of brain-derived neurotrophic factor, vascular endothelial growth factor and~     other growth factors, formation of hemidesmosomes, and degradation of extracellular matrix~     and basement membrane, either directly or by activating matrix metalloproteinases.~      Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells -~     plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle~     interventions proven effective in maintaining glucose and insulin levels within the normal~     range would increase the take home baby rate in women undergoing assisted reproduction.~   "
31213|NCT02648542|"~     This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial~     direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS,~     tDCS, and the combination of the two to assess the effectiveness of the treatment.~   "
31214|NCT02648529|"~     This project intends to investigate children with idiopathic and cryptogenic localization~     related epilepsies, using a longitudinal assessment of structural and functional MRI data,~     in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the~     frequent observation of selective cognitive dysfunctions in such children, the~     pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI~     investigation of brain maturation showing striking age and region dependant patterns.~      The primary hypothesis is that some children with localization related epilepsies suffer~     from altered maturation in the epileptic brain regions, and that this abnormal maturation~     affects their cognitive abilities. 100 children with localization related epilepsies and 100~     matched controls will be prospectively enrolled during the first two years of the disease~     (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation~     once a year for 5 years. The brain maturation of these children will be longitudinally~     assessed using structural and functional MRI, and correlated with neuropsychological data.~     Investigators hope to demonstrate that children with localization related epilepsies and~     cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the~     epileptic activity and the altered cognitive processes. The finding could partly bridge the~     gap between these two abnormalities and help better understand their interaction and~     respective dynamic. Once validated, the study of regional brain maturation in children with~     epilepsy might be further used as a reliable surrogate marker or predictor of associated~     cognitive dysfunction.~   "
31215|NCT02648516|"~     Chronic HIV-1 infection is generally characterized by progressive CD4+ T cell depletion~     associated with risk of opportunistic infections. In clinical, about 20% of patients who~     exhibit stable viral suppression by HAART still fail to achieve sufficient immune~     reconstitution and often experience an increased risk of opportunistic infections.~     Granulocyte colony-stimulating factor-mobilized donor peripheral-blood stem cells based on~     HLA-mismatched allogeneic transplantation have been demonstrated to boost host immunity~     against tumor and promote hemopoiesis without acute graft-versus-host disease. Thus, it may~     represent a novel treatment as allogenic adoptive cell therapy (AACT). Here, the~     investigators propose a hypothesis that AACT can promote hemopoiesis in bone marrow and~     attenuate immune-mediated inflammation, which subsequently lead to the restoration of CD4~     T-cell counts and reconstitution of host immunity in HIV-infected patients.~   "
31216|NCT02648503|"~     Single center, prospective, randomized, single blinded, parallel group and controlled,~     assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex~     versus Standard of care on Quality of recovery in patient undergo elective laparoscopic~     cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40),~     one(D1) and three(D3) days after surgery~   "
31217|NCT02648490|"~     This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose~     (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer~     who have failed standard therapy and deemed unamenable by conventional therapy. This study~     will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor~     effect of HLX07 and explore the potential prognostic and predictive biomarkers.~   "
31240|NCT02648191|"~     Faced with the current obesity epidemic, new avenues of research into effective weight loss~     must be developed.~      Among the possible actions on obesity, vagus nerve stimulation has been shown in several~     studies to be effective in treating epilepsy or depression, at the same time inducing weight~     loss in those patients. Vagus nerve stimulation has also shown to be effective on weight~     loss in experimental animal studies. Vagus nerve stimulation has never been attempted in~     obese patients awaiting bariatric surgery.~   "
31241|NCT02648178|"~     This study will test feasibility, in smokers with lung, head & neck, and bladder cancers,~     that examines the effect of e-cigarette substitution, on measures of smoking-related~     toxicity and medical outcomes. The aim of the study is to determine the appeal of~     e-cigarettes compared to regular combustible cigarettes.~   "
31218|NCT02648477|"~     This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works~     compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane)~     in treating patients with triple-negative or hormone-receptor positive breast cancer that~     has spread from the primary site (place where it started) to other places in the body.~     Pembrolizumab is an antibody drug that blocks a molecule called programmed death (PD)-1.~     PD-1 is a molecule that that shuts down the body's immune responses and prevents the immune~     system from attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy~     that works to stop the growth of tumor cells by stopping them from dividing and by causing~     them to die. Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers~     estrogen levels in the body, which may help treat cancer that is hormone receptor-positive.~     Giving pembrolizumab together with standard treatment of either doxorubicin hydrochloride~     (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be~     an effective treatment for these types of breast cancer.~   "
31219|NCT02648464|"~     This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent~     cardiovascular events among myocardial infarction patients. Half of the participants will~     receive hydroxychloroquine, whereas the other half will receive placebo during six months.~   "
31220|NCT02648451|"~     -  To evaluate tolerance and acceptability of AYMES ROME in patients requiring~          supplementary oral nutritional support compared with currently available alternatives.~        -  To obtain data to support a submission to Advisory Committee on Borderline Substances~          (ACBS) for AYMES ROME (to allow for prescription in the community at National Health~          Service (NHS) expense).~   "
31221|NCT02648438|"~     This is an open-label,partially randomized, four-period study in healthy male subjects to~     assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when~     administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs)~     and a pressurized meter-dose inhaler (pMDI)~   "
31222|NCT02648425|"~     This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in~     combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a~     view to identifying the recommended Phase II dose.~   "
31223|NCT02648412|"~     The aim of the study was to describe the relationship between the intensity of a~     standardized tetanic stimulation and the associated reflex pupillary dilation in patients~     under ketamine sedation.~      After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every~     minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the~     stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured~     before and after each stimulation.~   "
31224|NCT02648399|"~     This study recruit the patients with unilateral papillary thyroid cancer before~     operation,the patients agree to enter the test,and divided into experimental and control~     group.experimental group patients receive the surgery including unilateral thyroid lobectomy~     and bilateral central lymph node dissection.and control group receive the surgery including~     unilateral thyroid lobectomy and unilateral central lymph node dissection.last the~     investigators compare numbers of patient with tumor recurrence and metastasis rate of 5~     years,numbers of metastatic lymph node,and numbers of participants with adverse events~     related to treatment between two groups in order to evaluate the significance of bilateral~     lymph node dissection.~   "
31225|NCT02648386|"~     Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer~     treatment. The purpose of this study is to assess the safety and efficacy of autologous bone~     marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem~     cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile~     dysfunction after rectal cancer treatment.~   "
31226|NCT02648373|"~     The purpose of this study is to evaluate patients with low back pain who are scheduled to~     begin physical therapy but have not yet had their first appointment to better understand~     their beliefs and attitudes and to evaluate the effects of an educational session about low~     back pain.~   "
31227|NCT02648360|"~     Hispanics share a disproportionate burden of several of the nation's leading chronic~     diseases caused by poor lifestyle habits such as sedentary behavior and poor quality~     nutrition intake. This project will design, implement and evaluate the delivery and~     effectiveness of an existing health promotion text messaging program focused on increasing~     physical activity and improving dietary behaviors among medically underserved Hispanic~     patients. Adult Hispanic patients referred by their healthcare provider at a local free~     community health clinic will be invited to participate in the 4-month long study. Patients~     who agree to participate will be sent health promotion text messages and will complete a~     brief pre-post assessment battery. Patients who do not send an initial enrollment text (to~     agree to participate) will receive a follow up telephone call from the research team to~     encourage participation. Evaluations will consist of: (1) physician referral rates; (2)~     patient enrollment rates; (3) demographic differences (gender, age) in~     participants/non-participants; and (4) pre-post changes in levels of physical activity and~     quality dietary intake will be conducted. The results of this study will provide a better~     understanding of the feasibility and effectiveness of implementing referral-based text~     messaging programs among medically underserved Hispanic patients at high risk for chronic~     diseases.~   "
31228|NCT02648347|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of~     anemia and maintenance of hemoglobin (HGB) in subjects with NDD-CKD~   "
31229|NCT02648334|"~     This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA)~     using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral~     Artery disease.~   "
31230|NCT02648321|"~     The purpose of this study is to determine whether motivational intervention is effective in~     promoting exercise habit in patients with psychosis.~   "
31251|NCT02648048|"~     This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and~     tolerability of vismodegib in combination with pirfenidone in participants with idiopathic~     pulmonary fibrosis (IPF) currently being treated with pirfenidone.~   "
31252|NCT02648035|"~     The purpose of this study is to evaluate the percentage of participants treated with~     subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that~     play a major role in continuation of treatment.~   "
31231|NCT02648308|"~     Results from the 5As Team (5AsT) Study have identified critical gaps in medical school~     curricula on obesity, leading to a wave of new family physicians who are unconfident and~     poorly equipped to manage obesity with their patients. In an effort to address this gap, all~     first year medical residents training in family medicine at the University of Alberta during~     the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part~     of the Doctor-Patient Relationship Course. The workshop will focus on knowledge, intangible~     skills and practicing the 5AsT approach to obesity management with patients of all~     demographics. The objective of the 5AsT MD2 study is to evaluate the impact of this workshop~     on the residents' attitudes and beliefs about obesity, as well as their level of confidence~     in using key aspects of the 5As of obesity management to help their patients. Participants~     will be asked to complete and submit pre- and post- knowledge assessments, narrative~     reflections and questionnaires assessing their beliefs and attitudes towards people living~     with obesity as part of their core requirements for the course. For those who consent to~     participate in the study and release their de-identified course assignments, we will~     evaluate the impact of the workshop using both quantitative and qualitative methods. The~     results will assist us in gaining information that may help us improve and further refine~     curricular materials for physicians and medical trainees.~   "
31232|NCT02648295|"~     Blood management is an important part of successful total joint replacement. Loss of blood~     and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has~     become a standard component to many blood management programs. It is used to treat or~     prevent excessive blood loss during surgery and in various medical conditions such as~     excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur~     naturally from growing and causing problems. When this process becomes overactive it can~     result in excessive bleeding, leading to increased blood transfusions. The proposed study~     seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.~   "
31233|NCT02648282|"~     This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody~     that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT~     (focused radiation) is effective (anti-tumor activity) and safe in patients with locally~     advanced pancreatic cancer.~   "
31234|NCT02648269|"~     This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose~     of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid~     levels. This will be followed, in separate subjects, by evaluation of the safety,~     pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of~     SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid~     levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that~     is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs)~     from forming.~   "
31235|NCT02648256|"~     Pneumocystis jirovecii pneumonia is a serious and frequent infection in immunocompromised~     patients, whose evolution is potentially fatal if untreated. It is the most common~     opportunistic infections classifying patients infected with human immunodeficiency virus~     (human immunodeficiency virus +) at the stage acquired immune deficiency syndrome. Data from~     the french Institute for Health Watch showed in 2011 that 31% of 1400 cases of acquired~     immune deficiency syndrome were revealed by Pneumocystis jirovecii pneumonia.~      Pneumocystis jirovecii pneumonia also increasingly concerns immunocompromised human~     immunodeficiency virus negative patients, due to the increasing use of immunosuppressive~     therapies (including corticosteroids), of anticancer cytostatics and biotherapies, in the~     context of grafts, transplants, but also from autoimmune or inflammatory chronic diseases.~      Recent data show that the number of cases occurring in patients Pneumocystis jirovecii~     pneumonia human immunodeficiency virus - in France is now higher than the cases occurring in~     Pneumocystis jirovecii pneumonia +. The severity of the Pneumocystis jirovecii pneumonia is~     increased in patients with human immunodeficiency virus -, in whom the evolution is faster,~     with mechanical ventilation often required and higher mortality, requiring a fast and early~     diagnosis. Routine diagnosis relies on the detection of the fungus in the bronchoalveolar~     lavage, using stains (May Grunwald Giemsa or immunofluorescence) and Polymerase Chain~     Reaction. Polymerase Chain Reaction provides a diagnostic gain in immunocompromised patients~     not infected with human immunodeficiency virus that may present a pejorative table quickly~     despite low fungal burden. However, the deoxyribonucleic acid of the fungus can sometimes be~     detected in the absence of scalable Pneumocystis jirovecii pneumonia, and then shows a~     pulmonary colonization by Pneumocystis jirovecii. It is therefore important to improve the~     positive predictive value of Pneumocystis Polymerase Chain Reaction, to guide the management~     of optimal patient.~      In this work, the investigators propose to evaluate the Polymerase Chain Reaction on~     oropharyngeal rinse, non-invasive sampling and therefore probably less often positive and~     specific active infection. The investigators will develop a quantitative Polymerase Chain~     Reaction to identify a fungal load threshold number of copies / mL for diagnosing~     Pneumocystis jirovecii pneumonia with better positive predictive value.~   "
31236|NCT02648243|"~     In Qatar, cardiovascular diseases (CVD) have become the leading cause of morbidity and~     mortality over the past two decades. Between 1991 and 2010, a total of 16,736 patients were~     admitted with ACS (Acute Coronary Syndrome) in Qatar. Despite the use of percutaneous~     coronary intervention (PCI), coronary artery bypass graft (CABG), and pharmacological agents~     to acutely reduce vascular risk, ACS patients are at high risk of having further~     cardiovascular events. Consequently, secondary cardiovascular risk reduction therapy is~     needed for all CAD (Coronary Artery Disease) patients. Clinical practice guidelines~     recommend that following ACS, patients should receive indefinite treatment with aspirin, a~     beta blocker, an angiotensin converting enzyme inhibitor (ACEI) or alternatively angiotensin~     II receptor blocker (ARB) and a statin. Less than 80% of ACS patients in Qatar use this~     quadruple combination after discharge. This creates a significant opportunity for~     pharmacists to improve CVD management and outcomes in Qatar. Nothing is known about the~     impact of Qatar clinical pharmacists as direct patient-care team members at discharge and~     post-discharge on the short-term and long-term outcomes of ACS patients. The proposed study~     is aimed to determine this impact. The investigators hypothesize that a clinical~     pharmacist-delivered intervention consisting of medication reconciliation and counseling at~     discharge and tailored follow-up post-discharge will decrease hospital readmissions,~     emergency department (ED) visits and all-cause mortality at 3 month, 6 months and 12 months~     after hospital discharge when compared with control arm and pharmacist delivered~     intervention at discharge only among ACS patients. The investigators also hypothesize that~     the effect of the intervention will increase patients' adherence to evidence-based secondary~     prevention medications for CAD (Coronary Artery Disease), and patient satisfaction with~     pharmacy services. Besides, this intervention will reduce the treatment burden on patients.~   "
31237|NCT02648230|"~     The model by which physicians measure the lack of blood flow in the vessels that supply~     blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of~     the pressure across the vessels that supply blood to the heart. These are known as the~     coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical~     Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the~     devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas~     standard angiography can underestimate or overestimate narrowing, because it only visualizes~     contrast (the different areas of color) inside a vessel.~   "
31238|NCT02648217|"~     This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and~     safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice~     daily in subjects with type 2 diabetes mellitus before, during and after Ramadan.~   "
31239|NCT02648204|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and~     safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2~     diabetes.~   "
31242|NCT02648165|"~     Depression (major depressive disorder; MDD) is a very common mental disorder. Research~     suggests that individuals with prior depressive episodes have a risk of the relapse or~     recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term~     management of the disease. The current project aims to investigate whether group based~     Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse~     in a group highly vulnerable to depressive episodes. The group intervention will consist of~     eight sessions, and each group will consist of maximum 12 persons. The project also studies~     whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the~     effect. ABM will be administered over a fourteen days period prior to the ACT-intervention.~     Effect will be measured over a period of 12 months. The primary outcome is changes in~     depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects~     with a history of major depression (n=200), currently in remission, will be recruited from~     Sørlandet Hospital (100 participants). Matched participants (100 participants) will be~     recruited at the University of Oslo. In the first phase, participants from Sørlandet~     hospital will be randomized to ABM treatment or control condition. In the second phase all~     participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT~     and ABM represent interventions that are time and cost effective, and that could be made~     available to large number of individuals struggling with MDD.~   "
31243|NCT02648152|"~     Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art~     implant in terms of radiographic, clinical performance and long-term survivorship.~   "
31244|NCT02648139|"~     In the present randomized, controlled, double-blind clinical trial, we investigated the~     short term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit~     extract in preventing gingivitis in children.~   "
31245|NCT02648126|"~     The purpose of this study is to determine occurrence of pure red cell aplasia in a group of~     participants with chronic renal insufficiency and with resistance criteria to epoetin alfa~     treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and~     it is provided by the Unified Health System.~   "
31246|NCT02648113|"~     Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting~     in poorer outcome. There is equipoise regarding which transfusion strategy is best, and~     there is an international consensus on the urgent need for a randomized trial.~      The investigators hypothesize that a restrictive transfusion strategy is at least~     non-inferior to a liberal transfusion strategy on 30-day outcomes of MI patients with~     anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility~     analysis becomes key to determining the role of each strategy.~   "
31247|NCT02648100|"~     Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis~     and no target therapies for this pathology are currently validated. By 40 gene expression~     signature realized on frozen samples, we have previously identified an aggressive sub-class~     of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro~     and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation~     suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim~     is to establish a standard diagnostic tool to differentiate the basal subtype of bladder~     cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial~     (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR~     associated chemotherapy.~   "
31248|NCT02648087|"~     There is a possible implication of sleep apnea syndrome via night-time intermittent~     hypoxemia in perturbation of quality of life and tumour progression to patients with a~     bronchial cancer.~      The aim of the study is to evaluate this possibility with the help of a night record of~     sleep and quality of life questionnaires.~   "
31249|NCT02648074|"~     Asthma is a chronic, inflammatory disease of the lung characterized by intermittent airway~     obstruction, airway hyperresponsiveness, presence of activated inflammatory cells,~     inflammatory mediators, and airway structural changes. Airway smooth muscle (ASM) cells~     actively participate in the remodelling and inflammatory processes through proliferation,~     release of proinflammatory cytokines, chemokines, and extracellular matrix (ECM) proteins.~     Eosinophils as essential inflammatory cells may be of importance in ASM remodelling. It is~     known that eosinophil induces ASM cells proliferation via the secretion of cysteinyl~     leukotrienes in asthmatics. However there is a possible direct eosinophil-ASM cells~     functional interaction by adhesion processes. It has been shown that integrins modulate ASM~     proliferation and contractile protein expression demonstrating allergen-induced ASM~     remodelling in an animal model of allergic asthma.~      Wingless/integrase-1 (WNT) signaling regulates not only a wide range of developmental~     processes, but its aberrant activation can lead to disease. Recently, it was confirmed that~     genes polymorphisms in the WNT signaling pathway are associated with impaired lung function~     in childhood asthma. It was also found for the first time a relevant role of noncanonical~     WNT signaling in TGFβ-induced ECM expression by ASM cells and identified WNT-5A is the most~     abundant WNT ligand with increased expression in asthmatics. It demonstrates that WNT-5A~     could contribute to remodelling of the airways. Unfortunately, the effect of eosinophil on~     WNT secretion by ASM cells at present is unknown.~      Despite the widely acknowledged significance of eosinophils in asthma pathogenesis, the~     mechanism of eosinophil induced ASM remodelling is unsolved.~   "
31250|NCT02648061|"~     Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of~     successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall~     prognosis after ROSC has not improved much and the in-hospital mortality is still reported~     to be 50 to 70 %. The post-resuscitation disease is now called the post-cardiac arrest~     syndrome (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic~     ischemia and reperfusion.~      Treatment of patients after cardiac arrest has often followed guidelines that were primarily~     developed for treatment of septic shock. It is still uncertain whether this is the optimal~     way to deliver circulatory support after cardiac arrest.~      There is a lack of studies assessing the relationship between the inflammatory response~     measured by inflammatory biomarkers and circulatory failure in PCAS.~      In this study a detailed description will be given of the clinical trajectory of the~     circulation and the inflammatory response during the first 5 days after cardiac arrest, and~     it will be investigated whether patterns of circulatory and inflammatory response may be~     predictive of deterioration of clinical state.~   "
31254|NCT02648009|"~     The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the~     health care system's most expensive diagnoses. Despite major advances in medicine, the~     mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI)~     is used for non-invasive imaging of the cardiovascular system to enable the structure and~     anatomy of the organ to be visualized. However, current MRI methods have limitations when~     assessing and aiding in the management of CHF. A new imaging method has recently been~     developed that is showing great promise as a tool in the management of patients with CHF.~     Rapid imaging of biochemical reactions within myocytes using MRI has recently become~     possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method.~     DNP-dissolution results in an intravenous contrast agent that is hyperpolarized, producing~     a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13~     labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human~     heart, along with the required hardware and data acquisition methods.~   "
31255|NCT02647996|"~     To compare functional connectivity after severe traumatic brain injury (TBI) between a group~     of post-comatose TBI with restored consciousness and a group of post-comatose TBI with~     persistant disorder of consciousness at admission in rehabilitation~   "
31256|NCT02647983|"~     Prostate cancer is the most common malignancy among men in the United States and Canada.~     Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE)~     and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological~     diagnosis. However, this technique misses cancer in nearly one quarter of patients and finds~     clinically insignificant disease in another third of patients, resulting in over-treatment~     and unnecessary morbidity.~      MRI is the best imaging method for prostate cancer detection, but current techniques cannot~     reliably predict tumour grade and are often unreliable for localizing cancer, particularly~     within the transition zone, where specificity is low. The primary objective of this pilot~     study is to evaluate the added benefit of localizing prostate cancer and predicting tumour~     grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and~     diffusion-weighted MR imaging.~      The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting~     prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground~     truth histology, using whole-mount prostate specimens. The results of this study will~     provide insight into the prostate cancer disease signatures with MRI and determine if there~     is added benefit for incorporation of this new technique into future clinical MRI protocols.~     If future imaging tests could determine the size, grade and extent of disease, this would~     open the door for less invasive, localized treatment options with reduced morbidity.~   "
31257|NCT02647970|"~     The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1)~     activity through dietary interventions can increase energy metabolism in humans.~   "
31258|NCT02647957|"~     Code Stroke is a system for the rapid identification, pre-notification and transport of~     acute ischemic stroke patients. The objective of this study was to define quality indicators~     and to compare treatment outcomes in hospitals where Code Stroke has been implemented and~     hospitals without the use of Code Stroke (control patients).~   "
31259|NCT02647944|"~     Obesity is associated with differences in stomach function, feeling of fullness after meals,~     and total calories consumed at a buffet meal. Based upon previous research, our study~     hypothesis is that weight loss with pharmacological agents may be individualized, based on~     the abnormality in those gastrointestinal functions. These studies will provide support for~     the principle that specific obesity medications should be selected according to individual~     characteristics, and it is anticipated that this approach will enhance efficacy of~     medication treatment of obesity.~   "
31260|NCT02647931|"~     Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient~     population with reported dysphagia who exhibit normal oropharyngeal and esophageal~     swallowing function as evidenced by videofluoroscopic swallow study. These patients also~     demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of~     laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with~     Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention~     targeting the unloading of the supraglottic muscle tension has been shown to be highly~     effective in symptom resolution per the investigators' clinical experience. The study is~     designed to answer efficacy of treatment being offered to patients with muscle tension~     dysphagia.~   "
31261|NCT02647918|"~     The purpose of this study is to evaluate the effect of mild, moderate, or severe renal~     impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and~     tolerability of 1 or 2 single doses of sotagliflozin compared with healthy,~     demographically-matched subjects with normal renal function.~   "
31262|NCT02647905|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics~     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with~     reference standard measurements The investigation will also evaluate safety of the~     Senseonics CGM System usage.~   "
31263|NCT02647892|"~     The purpose of this study is to determine the optimal amount of lidocaine buffering needed~     to decrease injection pain when administering local anesthesia.~   "
31264|NCT02647879|"~     The main aim of this study is to test in the Icelandic population the hypothesis that a~     nationwide treatment program which offers effective treatment to all known cases of~     Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a~     reduction in incidence and disease burden associated with chronic HCV infection.~   "
31265|NCT02647866|"~     The purpose of this study is to determine the safety and tolerability of administration of~     multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects~     with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy~     (LTE) phase for eligible subjects with a clinical response.~   "
31266|NCT02647853|"~     This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested~     the safety, tolerability, and plasma pharmacokinetics of two different concentrations of~     TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.~   "
31575|NCT02643797|"~     This study is a cluster (clinic level) randomized pragmatic trial to compare the~     effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff~     (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals~     with poorly controlled type 2 diabetes mellitus (T2DM).~   "
31267|NCT02647840|"~     This study wants to investigate treatment for patients with common voice disorders where no~     surgical or medical treatment is needed. A voice disorder is when your voice is croaky,~     hoarse or when you lose it altogether. This can be a serious problem for people as it stops~     them from participating in their normal life (for example in their jobs, hobbies, family and~     wider social life).~      This study will look at our most commonly used method of treatment for voice problems. This~     method is based on physical exercises which work on the muscles which produce the voice.~     This voice work was originally developed by Jo Estill, a singer and scientist, and is widely~     used in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice~     therapy based on the Estill model, there is no clinical evidence to support its use.~      The aim of this study is to test the design for a larger research study into the effects of~     voice therapy based on Estill model of voice. We want to find out if our tests work and are~     easy to use, and to check that the study methods are right and would work on a larger scale.~     It is a feasibility study, and therefore allows us to test whether this study can be done.~     Another important part of this study is to involve patients in developing research. We want~     to find out what patients think about the treatment they receive, and about taking part in a~     study.~      The way this study will work is that patients who have agreed to take part will have between~     four and six voice therapy appointments, just like they would if they were not part of the~     study. Voice test results from before and after treatment will be compared and carefully~     studied. After patients taking part in the study have finished their treatment, they will be~     asked about their experience of voice therapy, and of being in the study. Much of what will~     be done as part of the study is identical to what is normally done in treatment, however we~     will look in detail at all the tests, and we need permission from participants to use their~     test results and include their comments.~      It is important to learn more about voice therapy and to improve voice therapy for patients~     with this type of voice problem. By finding out more what patients think about the treatment~     we provide, what tests to use, and about how best to run a research trial, we will be able~     to plan further research and hopefully be successful at a next large research grant~     application.~   "
31268|NCT02647827|"~     The hypothesis is that acupuncture is equally effective as metformin (both treatments~     combined with lifestyle management) in improving whole body glucose homeostasis in insulin~     resistant women with polycystic ovary syndrome (PCOS), and that both are superior to~     lifestyle management alone. The investigators hypothesize that acupuncture and metformin~     induce ovulation and improve hyperandrogenism, as well as health related quality of life~     (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and~     metformin), the investigators hypothesize that acupuncture is associated with less negative~     side-effects. The investigators also hypothesize that these treatments have the potential to~     restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and~     skeletal muscle tissue) and thus have the potential to prevent the development of type 2~     diabetes (T2D).~   "
31269|NCT02647814|"~     Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a~     parent support intervention consisting of periodic text messages and educational support~     (video, collateral materials),and usual care on the healthcare engagement of limited English~     proficient (LEP) Latino parents during their child's first year and to examine its impact on~     healthcare utilization and primary care quality.~   "
31270|NCT02647801|"~     The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which~     enables to investigate the complex, interdependent network of self-control and its~     influences in everyday life. By adding an intervention to the network, such as mindfulness~     training, it is also possible to explore the way mindfulness changes connection strengths~     between network variables.~      For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are~     conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized~     to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take~     place to assess self-reported trait self-control and mindfulness and a behavioral measure of~     mindfulness (Levinson, Stoll, Kindy, Merry & Davidson 2014). Participants of both the~     experimental and control condition come to five weekly lab meetings in which they fill out~     questionnaires to assess changes in self-reported self-control and mindfulness. But only~     participants of the experimental condition take part in weekly computer based mindfulness~     trainings. During the ambulatory assessment, participants complete questionnaires six times~     a day via mobile phones that are randomly prompted and answer questions about state~     self-control, motivation, affect, and current situation.~   "
31271|NCT02647788|"~     The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen~     (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after~     hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.~   "
31272|NCT02647775|"~     Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been~     shown to reduce postoperative discomfort, and has improved cosmetic results when compare to~     open thoracotomy. The specific aims of this project are: to clarify the physiologic and~     immunologic effects of different approaches for minimally invasive thoracic surgery: (1)~     multiple-port VATS; (2) single-port VATS~   "
31273|NCT02647762|"~     This trial will test the hypothesis that the administration of CF101, a novel~     anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and~     symptoms of the disease. CF101 effect will be in comparison to MTX in this study population.~   "
31274|NCT02647749|"~     This current care protocol follows the biomedical research protocol entitled Non-invasive~     mapping of the heart ECG high amplification that demonstrated the clinical value of~     noninvasive Cardioinsight® mapping system.~      Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of~     cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of~     serious arrhythmias or sudden death, with the currently used non-invasive mapping routine.~     The results obtained with non-invasive mapping will be compared with those obtained with the~     conventional method without non-invasive mapping.~   "
31275|NCT02647736|"~     Kinetics of Copeptin in response to osmotic alterations in healthy volunteers~   "
31276|NCT02647723|"~     The purpose of the study is to test whether nutritional supplementation during pregnancy is~     associated with 1) improved maternal health during pregnancy; 2) improved infant birth and~     neurodevelopmental outcomes, and 3) whether the association between nutritional~     supplementation during pregnancy and infant outcomes is partially mediated by reductions in~     maternal perceived stress and stress reactivity during pregnancy.~   "
31277|NCT02647710|"~     PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for~     recently-arrested juvenile offenders on probation. The program will teach teens about~     HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research~     Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The~     investigators will test and compare PHAT Life to the health promotion control group on~     adolescent risky sexual behavior, substance use, and theoretical mediators.~   "
31278|NCT02647697|"~     To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy~     adult subjects.~   "
31279|NCT02647684|"~     The purpose of the study is to assess the characteristics of parents who enroll in parenting~     interventions and to assess the utility and efficacy of a self-directed Triple-P~     intervention for parents of children with a diagnosis of cancer. The study aims to recruit~     parent(s) or primary caregiver of children with a diagnosis of cancer.Participants will be~     parents of children aged between 3-10 years who have had a diagnosis of cancer for 6 months~     or more. Recruitment will take place nationally via cancer voluntary groups/charities and~     other relevant organisations. The project will be advertised through these organisations and~     their various media outlets such as newsletters and social media pages (e.g. Facebook). All~     data collection will take place online. Following completion of the initial survey, parents~     will have the option to opt in to a case series whereby 10 parents will have the opportunity~     to receive the Triple P Every parents self- directed workbook to complete over 10 weeks.~   "
31280|NCT02647671|"~     In the proposed study, investigators will conduct a 90-day dietary intervention study in~     human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be~     randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a~     comparable level of calcium alone. There will also be a placebo group. Prior to ingesting~     the study agents and following the course of treatment, colonic biopsies will be obtained by~     sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this~     study, metabolomic and microbial profiles will also be generated from fecal and colon~     mucosal samples taken at baseline and study endpoint.~   "
31281|NCT02647658|"~     Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be~     self-limited (acute), but some people can progress to a state of persistent pain. Often~     termed chronic LBP (cLBP), this condition can cause prolonged difficulty with most daily~     activities, including job performance. Most patients see chiropractors or primary care~     physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for~     preventing patients with acute LBP (aLBP) from developing cLBP. Both treatments can be~     delivered in an outpatient PCP setting. The first approach is to provide PCPs with~     information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage~     PCPs to treat patients according to accepted clinical guidelines. The second approach is to~     provide the same risk information and have PCPs team up with physical therapists to deliver~     psychologically-informed physical therapy (PIPT) for those patients determined to be at high~     risk for transitioning to cLBP. PIPT is designed to help patients identify and overcome~     physical and psychological barriers to recovery. The 3,000 patients expected to be recruited~     from five regional sites (Pittsburgh, PA; Boston, MA; Baltimore, MD; Charleston, SC; and~     Salt Lake City, UT) will start the study when their LBP is in an acute phase. The study's~     primary aims are to compare the proportions of cLBP and measures of functional ability~     between the two groups at 6 months. Secondary aims are to compare these outcomes between the~     two groups at 12 months and measure the number of low back-related x-rays, MRIs, surgeries,~     and other medical procedures during the follow-up period. The same outcomes will be assessed~     for an observational cohort of 9,000 patients with aLBP at low to medium risk for~     transitioning to cLBP across the 5 sites. This study was designed with input from a variety~     of national and local stakeholders, including patients with LBP, providers, payers,~     professional organizations, purchasers, and policy representatives.~   "
31282|NCT02647645|"~     The purpose of this study is to develop pilot data on the potential efficacy of~     computer-based cognitive training or the combination of computer-based cognitive training~     with transcranial direct current stimulation (tDCS) in improving cognitive function in~     persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain~     stimulation technique in which a small direct current (1-2 mA) is applied to the scalp~     during a cognitive or motor activity, inducing a very small current that affects specific~     neural circuits related to the site at which electrodes are placed. tDCS has been judged~     safe and has shown significant treatment effects in studies with other populations, but has~     not been extensively studied in individuals with HIV infection. tDCS has been shown to~     facilitate learning in a number of studies, suggesting that it may improve or enhance~     learning in those with cognitive problems. As HIV infection is associated with decrements in~     a number of cognitive skills, including working memory, executive functions, and psychomotor~     speed that are related to individuals' functional status and medication adherence, the~     demonstration of a technique to enhance the effects of cognitive training in this population~     would have substantial clinical benefits as well as scientific value.~   "
31283|NCT02647632|"~     The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients~     who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with~     Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the~     rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this~     treatment. SVR12 is defined as HCV RNA < LLOQ (either TD[u] or TND).~   "
31284|NCT02647619|"~     Aim:~      Clinical RCT comparing functional results and recurrence rate following enzymatic treatment~     vs. needle aponeurotomy.~      Materials and methods:~      30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of~     the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP)~     joint. Patients with primary disease of the hand. Total of 80 patients needed to detect~     difference of 13.5°.~      1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks,~     16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ,~     VAS pain and VAS patient satisfaction. Total passive extension contracture reduction,~     recurrence rate and registration of complications.~   "
31285|NCT02647606|"~     Videolaryngoscope is useful to improve the laryngeal view, especially during difficult~     intubation. There are several kinds of videolaryngoscopes and it is applicable during~     nasotracheal intubation. In this study, the investigators will compare the McGrath~     videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in~     patients with manual in-line stabilization.~   "
31286|NCT02647593|"~     Laboratory change induced by common bile duct (CBD) stone is in general observed as the~     higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in~     comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).~     However, some patients with CBD stone show the marked increased level of aminotransferase,~     which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis,~     ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic~     features of patients with CBD stones with the high level of aminotransferase in serum.~   "
31308|NCT02647307|"~     The proposed study is not hypothesis testing but is intended to explore the effects of~     different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK~     (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b.~      Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be~     followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety~     & tolerability.~   "
31287|NCT02647580|"~     Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and~     thus, a sign of undernutrition. This study will include children with FTT, and compare with~     existing data from children with normal and excessive growth.~      The overall aim of this study is to explore whether 1) children who develop FTT with no~     organic explanation differ from healthy normal weight and overweight children in their basal~     level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in~     children can be partly predicted by variation in their gut microbiome and metabolome.~   "
31288|NCT02647567|"~     Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant~     properties, and their intake when in moderate doses seem to produce positive effects on~     stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be~     displayed also on cognition, as caffeine, when in proper proportions, the investigators do~     not know if the joining of the two strategies into a single activity would be able to~     promote additional effects enhancing cognitive processes related to memory, attention, and~     motor reaction time.~   "
31289|NCT02647554|"~     A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of~     Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China~   "
31290|NCT02647541|"~     The hypothesis of this study is a nutrition preoperatively in infants and children~     undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in~     nutritional status, intervention, and that this results in good postoperative results.~   "
31291|NCT02647528|"~     A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser~     (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris~   "
31292|NCT02647515|"~     To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the~     treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular~     glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing~     postoperative intraocular pressure（IOP）control.~   "
31293|NCT02647502|"~     Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model~     of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are~     also associated with less severe disease in mice who do develop the disease. Currently,~     whether these results translate favorably in humans is unknown. This is a pilot trial of~     testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS)~     patients: one continuous caloric restriction (CR) diet where a small number of calories will~     be restricted every day or another intermittent CR diet where a caloric intake will be~     restricted more severely 2 days per week. Participants are randomized to one of the diets,~     and for the first 8 weeks, will receive standardized, prepared meals tailored to the~     specific diet. At the conclusion of the controlled feeding study, all participants will~     transition to an unblinded phase for an additional 40 weeks where they are provided with~     instructions to follow an intermittent CR diet.~   "
31294|NCT02647489|"~     Despite having developed robust acquired immunity against complications of malaria, women~     can return to a susceptible state during their first pregnancies and contribute~     significantly to the burden of severe malaria in highly endemic areas. Naturally acquired~     protection against placental malaria correlates with the presence of high concentration of~     immunoglobulin G molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family~     that is essential for the binding of infected erythrocytes to CSA in the placenta.~      To induce high concentrations of specific IgGs, subjects will receive escalating doses of~     PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable~     Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ).~     Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0,~     28 and 56). Control subjects will receive physiological saline instead of the vaccine and~     dose escalation will be staggered to ensure safety during the trial.~   "
31295|NCT02647476|"~     Immunomodulating enteral nutrition in the perioperative period may reduce postoperative~     complications in cancer patients. Little is known if this effect translates to the better~     survival.~      The aim of study was to assess the impact of postoperative immunomodulating enteral~     nutrition on postoperative complications and survival of gastric cancer patients.~      The group of 98 gastric cancer patients were randomly assigned for postoperative~     immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral~     nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month,~     1-year and 5-year survival were analyzed.~   "
31296|NCT02647463|"~     Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention~     delivered in families' homes or other places of residence. By helping parents of infants~     provide nurturance when their children are in distress, follow their children's lead, and~     behave in non-frightening ways, the ABC intervention has been previously found to enhance~     children's attachment quality and children's ability to regulate behavior, physiology, and~     emotions. The purpose of the present study is to examine the effectiveness of ABC in the~     context of community-based implementation efforts. Outcome assessments will include parent~     sensitivity, attachment quality, and cortisol regulation. The investigators hypothesize that~     parents randomly assigned to receive the ABC intervention will show higher levels of~     sensitivity at follow-up than parents randomly assigned to the waitlist control condition;~     and children randomly assigned to the ABC intervention will show higher rates of secure~     attachment and more normative profiles of cortisol than children randomly assigned to the~     waitlist condition.~   "
31309|NCT02647294|"~     Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be~     randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At~     the beginning and at the end of the study basic clinical and anthropometric data, as well as~     parameters of liver steatosis and fibrosis will be tested.~   "
31310|NCT02647281|"~     This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled,~     dose escalation study to determine the safety, tolerability and pharmacokinetics (PK)~     profile of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2)~     in healthy subjects. This study represents the first administration of GSK3389404 in humans~     to define the safety, tolerability and PK following single and multiple doses of GSK3389404~     in healthy subjects.~   "
31576|NCT02643784|"~     This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the~     efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.~   "
31297|NCT02647450|"~     An estimated 90,000 patients are suffering from long term gastrointestinal problems after~     cancer treatments, and whilst the National Cancer Survivorship Initiative have been working~     to develop specific pathways of care, these pathways lack in both specialised tariff funding~     and awareness. This study aims to assess the economic and personal impact on patients~     suffering from stomach and/or bowel problems after cancer treatment prior to referral to the~     Gastrointestinal and Nutrition Team (GIANT) at the Royal Marsden Hospital. All patients~     referred to the GIANT service (including private patients but excluding re referrals) will~     be offered participation in the study.~      The study will consist of a 9 page patient retrospective questionnaire, asking questions~     about investigations and medications prescribed over the past year, as well as costs and~     methods of trying to treat their symptoms themselves, and the personal cost to themselves of~     their symptoms through loss of work and emotional impact. As this questionnaire asks~     patients questions about the past year, and thus can be difficult to answer accurately,~     patient answers will be validated for reliability by sending a 1 page questionnaire to their~     GP asking the same questions about clinic visits concerning stomach/bowel problems,~     investigations and medications prescribed in the past year. Once this data is collected from~     the participants, and the study has finished, the average cost of clinical interventions,~     economic impact, and personal impact, will be calculated.~      The results from this study will be useful in helping to show the economic burden of GI~     symptoms, and will provide evidence as to the economic benefit of specialised clinics for~     the consequences of cancer treatment; highlighting the need for a nationally recognised~     algorithm for management.~   "
31298|NCT02647437|"~     Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an~     anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy~     of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also~     hypothesize that LEV will improve neurocognition in patients with schizophrenia.~   "
31299|NCT02647424|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to~     10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility.~     Following lifestyle modification with weight reduction in obese PCOS women, clomifene~     citrate (CC) is considered the first line treatment for ovulation induction (OI) in these~     women. 75-80% of women will ovulate after CC administration. However, there is a discrepancy~     between the ovulation rate and pregnancy rate, which was reported to be 22% per each~     ovulating cycles after CC. Other alternatives, including gonadotropin injections and~     laparoscopic ovarian drilling, carried different disadvantages, such as costly treatment and~     risks of ovarian hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin~     therapy and surgical risks and risk of ovarian failure in surgical treatment.~      The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001.~     After this publication, there have been many groups of investigators studying the use of LTZ~     either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial~     reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In~     majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC~     group. This can be attributed to the higher chance of monofollicular development after LTZ~     compared with CC. However, there is no information comparing the hormonal profile and~     follicular development after letrozole and CC.~      Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is~     commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or~     mild factor to improve the pregnancy rate. There is again no information comparing the~     hormonal profile and follicular development after letrozole and CC in ovulatory women.~      The aim of this study is to compare the hormonal profile after the use of LTZ and CC in~     anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is~     that the FSH risk after LTZ is shorter than that of CC.~   "
31300|NCT02647411|"~     The purpose of this study was to evaluate the increased prevalence of myopia among patients~     in different periods in an ophthalmologic hospital in Goiania. There has been an increase of~     myopia prevalence around the world especially in some Asian countries. The investigators~     intend to analyze if this growing tendency is also present in our hospital, and if it exist~     how much is this growth.~   "
31301|NCT02647398|"~     Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the~     PREDICT questionnaire for fatigue, will be randomized to a supervised strength program~     versus a supervised resistance program. The primary objective is improvement of~     cancer-related fatigue.~   "
31302|NCT02647385|"~     The serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I~     (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery,~     since there is evidence of pain reduction. However, correlation between regional anesthesia,~     postoperative pain and inflammatory response in breast surgery has not been demonstrated.~     The aim of this study is to compare the standard intravenous analgesia versus systemic~     analgesia associated with the SAM block and PEC I during breath cancer surgery. The~     following parameters will be evaluated: consumption of opioid intra and post-operative;~     post-operative pain and release of plasma inflammatory cytokines. It is a clinical~     prospective, randomized and controlled study. 50 individuals will be randomly divided into~     two groups. A group of patients receive general anesthesia during surgery and intravenous~     analgesia after the surgery and another group will receive general anesthesia associated~     with SAM and PEC I block during intraoperative and postoperative systemic analgesia. The~     postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery~     room and 24 hours after surgery. Blood sample will be collected for determination of serum~     cytokines before surgery and 24 hours after the surgery.~   "
31303|NCT02647372|"~     This study provides an evaluation of 30 patients in 3 years, from the Unified Health System~     (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its~     intermediate stage and that the drug therapy is limited by side effects or beneficial~     effects provided by prior medication no longer be obtained even at high doses and have~     therefore the indication for treatment with deep brain stimulation.~   "
31304|NCT02647359|"~     This is a Phase 2, randomized, double-masked, placebo-controlled study of ataluren in~     patients with aniridia caused by a nonsense mutation. Patients will receive masked study~     drug for 48 weeks followed by open-label ataluren for another 48 weeks. Safety and efficacy~     will be assessed.~   "
31305|NCT02647346|"~     The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals~     associated with diabetic foot ulcers in high-risk patients.~   "
31306|NCT02647333|"~     In order to reduce cardiovascular risk, current European guidelines recommend a diet low on~     saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).~     Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results~     from recent meta-analyses investigating coronary risk outcomes did not clearly support a low~     intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this~     study is to investigate the short term effects of a high intake of PUFAs on microvascular~     function, lipids, inflammation and other cardiovascular risk factors in inactive patients~     with increased waistline.~   "
31311|NCT02647268|"~     Postpartum hemorrhage (PPH) is the loss of more than 500ml of blood within 24 hours after~     delivery. It is a major cause of maternal morbidity and mortality across the globe.~      Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby~     causing labor. A synthetic form of oxytocin is used in obstetric medicine in the same way.~     It causes the uterus to contract by acting at the oxytocin receptor (OTR). It is used for~     both the prevention and the treatment of PPH. By causing the uterus to contract, it~     constricts the blood vessels within it, thus reducing bleeding.~      Oxytocin is also used to augment labor in women with slow labor progression. Desensitization~     of the OTR after prolonged exposure to oxytocin occurs, leading to reduced contractions of~     the uterus with the same doses of oxytocin. This has been demonstrated in previous studies~     done by the investigators. The resultant need for a higher oxytocin dose to cause adequate~     uterine contraction has also been demonstrated in laboring women having received oxytocin~     for labor augmentation.~      Magnesium sulphate (MgSO4) is widely used within obstetric medicine. It is used for seizure~     prevention and treatment in preeclampsia and eclampsia, and is used for fetal~     neuroprotection in preterm labor, to reduce the risk of cerebral palsy. It is well-known to~     have a relaxant effect on uterine muscle, and as such, has been used as a tocolytic agent in~     preterm labour to prevent premature contractions and premature delivery. The effect of MgSO4~     on contractions in oxytocin pre-treated myometrium has not been fully elucidated with human~     lab studies. There are suggestions it may lead to increased oxytocin requirements or~     increased postpartum hemorrhage (PPH) in preeclamptic patients. This bears significance in~     the preeclamptic and eclamptic populations who are likely to be receiving MgSO4 in~     combination with oxytocin.~      The investigators hypothesize that MgSO4 will reduce uterine contractions in oxytocin~     pre-treated myometrium, as well as untreated myometrium, and higher oxytocin doses will be~     needed to produce equivalent contractions. This will help us to better understand the~     implications of the use of these drugs together in the clinical setting.~   "
31312|NCT02647255|"~     Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive~     immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well~     defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive~     therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a~     background of oral prednisolone and cyclophosphamide in prevent kidney failure.~   "
31313|NCT02647242|"~     Physical activity has demonstrated its beneficial effect on functional capabilities and~     quality of life in patients with PD. However, the daily physical activity remains limited in~     these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in~     patients with PD. The first results of BeatHealth studies have allowed us to identify the~     best musical stimulation to improve these parameters and the motivation of the patients.~      The originality of this study is to propose a gait auto-rehabilitation program using~     BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in~     PD.~      Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait~     parameters, balance, quality of life) will be evaluated.~   "
31314|NCT02647229|"~     The purpose of this physician blinded, randomized study is to determine the utility,~     effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral~     colonic purgative solutions for colonoscopy preparation. Patients will be randomized to~     receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus~     Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic~     irrigation and cleansing before endoscopic procedures.~   "
31315|NCT02647216|"~     The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive~     Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast~     cancer patients in recovery. Investigators will examine whether MBCT-related improvements in~     sleep quality, illness-related distress, and rumination (escalating cycles of negative~     thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2).~     Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity),~     individual differences (e.g., perceived stress, social support), clinical characteristics~     (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours~     of weekly practice) help determine for whom MBCT is most effective (Aim 3).~   "
31316|NCT02647203|"~     This study aims to test the effectiveness in reducing or arresting root caries lesion in~     community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded~     RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will~     be delivered to the participants in a blind format and they will be instructed to brush~     twice per day.~      Follow-up will be carries out every 6 months for two years to assess:~        -  Root caries incidence.~        -  Lesion arresting~        -  Changes in salivary flow~        -  Microbiology pattern shift~        -  Variations in oral health- related quality of life by OHIP-14 Sp~   "
31317|NCT02647190|"~     The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when~     used alone and together with chemotherapy and find out what effects, if any, it has on~     people.~   "
31318|NCT02647177|"~     The purpose To determine the diagnostic potential of various biological markers in blood and~     cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs).~      Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository~     study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst~     aspiration.~      Procedures to be used Blood Sample Cyst Fluid Sample~      Data Collection:~      Medical Record Number Demographics (age, sex, gender, race) Contact information History of~     alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history~     Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data~     of abdominal and chest regions, including and not limited to ultrasonography, magnetic~     resonance imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment~     including histopathological findings of resected specimens and blood reports End of study~     data: clinical progression of disease, cyst size, wall thickening, calcification,~     communication with pancreatic duct, string sign, cytology, immunohistochemical findings,~     assay levels of lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA~     19-9), and other biomarkers.~      Risks and potential benefits The risks associated with this study are slight discomfort or~     bruising from the blood sampling and the possible loss of confidentiality if the patient~     data or information is inadvertently disclosed outside of this study. The patient will not~     receive any additional benefit from the study aside from those received as part of routine~     standard of care.~      Importance of knowledge that may reasonably be expected to result The knowledge gained from~     this study may benefit other patients with Pancreatic Cyst Lesions in the future.~   "
31319|NCT02647164|"~     The purpose of this study is to assess the value of circulating tumor cells (CTC)for~     non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs,~     CT and tumor markers at different time points.The time of CTC and carcinoembryonic~     antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36~     months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36~     months after the surgery.~   "
31320|NCT02647151|"~     Photodynamic therapy technique (PDT) is a conventional technique which is performed applying~     the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a~     light source, usually red.~      The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with~     MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The~     pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and~     consequently it is more effectively.~   "
31321|NCT02647138|"~     Many patients complain to clinicians that they have difficulty sleeping appears to be due to~     environmental noise. There is a common perception that acute noises are more troublesome~     than continuous noises in the effect on individual sleep quality. Therefore the goal is to~     use a Marpac white noise maker with a continuous noise to see its effect on individuals that~     have difficulty sleeping in a high noise environment.~   "
31322|NCT02647125|"~     This primary objective of the trial is to study whether the local control of Huachansu plus~     thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with~     esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be~     recruited into the trial.~   "
31323|NCT02647112|"~     Clinical trial to determine the performance characteristics (sensitivity and specificity) of~     the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.~   "
31324|NCT02647099|"~     ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled,~     biomarker-based study of adjuvant treatment with low dose aspirin in patients with~     colorectal cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic~     mutations in PI3K pathway can significantly improve survival if treated with low dose~     aspirin.~   "
31325|NCT02647086|"~     This is an open-label, single-sequence DDI study designed to examine the effects of~     dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients~     with moderate to severe AD.~      The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7),~     study period 2 (day 8 to 50), and a follow-up period (day 51 to 135 [end of study]).~      Following completion of study period 2 (Day 50), patients will be given the option to enroll~     into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be~     followed for the next 12 weeks (Day 135).~   "
31326|NCT02647073|"~     Opioid dependence and its associated harms are becoming increasingly prevalent in North~     America, with overdose now being the second leading cause of accidental death in the US.~     This pilot study will investigate the feasibility of a novel mobile device to monitor vital~     signs in both opioid-injecting individuals and hospital inpatients who are on high-dose oral~     opioids. A secondary goal is to explore associations between consumption and changes in~     vital signs post-injection with the long-term goal of developing a mobile system that will~     alert clinicians when patients are at risk of overdose so that appropriate interventions can~     be delivered in time.~   "
31327|NCT02647060|"~     Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to~     the development of drugs, the prognosis of the disease has improved. However patients still~     have poor exercise capacity and decrease of the quality of life. Past studies have shown~     that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to~     further understand the difference between exercise capacity and quality of life of these two~     types of patients.~   "
31328|NCT02647047|"~     The purpose of this study is to evaluate the efficacy of spinal analgesia for minor~     laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale~     (VAS). The investigators expect at least the same post-operative pain control in the two~     groups (non inferiority of pain control with spinal analgesia compared to epidural~     analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease~     in patient's length of hospitalization according to enhanced recovery after surgery (ERAS)~     principles.~   "
31329|NCT02647034|"~     This study investigated clinical parameters, laboratory data, imaging studies to evaluate~     patients with suspected pulmonary hypertension.~   "
31330|NCT02647021|"~     The investigators will conduct a randomized controlled trial examining 12-week, 24-week and~     one year outcomes from a combined therapeutic and physical exercise program that aims to~     bridge head-and-neck cancer survivors from acute care rehabilitation services to~     community-based exercise programming.~   "
31331|NCT02647008|"~     Aim: To compare the pain-relieving effect of a specific application of TENS vs. placebo TENS~     and a control group during unsedated diagnostic office hysteroscopy.~      Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting.~     Population: Women who attended annual gynecological check up, and were indicated for~     diagnostic office hysteroscopy.~   "
31332|NCT02646995|"~     The purpose of this trial is to evaluate if the use of a newly developed lipid formulation~     versus fish oil would better enable the absorption of essential fatty acids after 12 weeks~     of supplementation.~   "
31333|NCT02646982|"~     This study is intended to investigate the effect of candesartan, a blood pressure~     medication, on cognitive function and thinking skills in those who have early or mild memory~     difficulties, also called mild cognitive impairment or MCI.~   "
31334|NCT02646969|"~     Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein~     concentrations over the first year of life~   "
31335|NCT02646956|"~     The goal of the study is to determine whether there are age-, diet- and genetically-related~     differences in the perception of sweeteners, both nutritive and non-nutritive.~   "
31346|NCT02646813|"~     The objective of this study is to evaluate the time and ease of placement of an~     extra-luminal Arndt bronchial blocker versus placing it intra-luminally.~      An additional objective will be to assess if there are any other significant clinical~     differences between these two approaches to placement of the BB including overall quality of~     isolation, an increase in post-operatives sore throat, post-operative hoarseness, and~     increased incidence of needing to reposition the blocker~   "
31347|NCT02646800|"~     The objective of this study is to evaluate the safety and efficacy of intravenous micafungin~     for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.~   "
31348|NCT02646787|"~     Using virtual reality as a form of distraction during a painful burn wound care procedure in~     addition to pain medication.~   "
31336|NCT02646943|"~     BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world,~     with 8-10 million infected people and only one marginally effective therapeutic. The lack of~     good biomarkers for active infection or clinical end-points poses a problem for assessing~     the performance of new drugs or therapeutic interventions. Among the biomarkers, several~     studies showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left~     ventricular systolic and diastolic dysfunction.~      OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine~     Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease~     Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma~     cruzi infection with the goal of finding an array of biomarkers that correlate with parasite~     persistence and Chagas cardiac disease status that can be used to infer risk of disease~     progression and death as well used as markers of cure (parasite eradication) or clinical~     efficacy (stabilize or reverse cardiac damage) of novel drugs~      METHOD: The investigators established a prospective cohort of 1,959 patients with chronic~     Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part~     of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline~     and 24 months) . The evaluation included collection of socio-demographic information, social~     determinants of health, health-related behaviours, comorbidities, medicines in use, history~     of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life,~     blood sample collection and ECG.~   "
31337|NCT02646930|"~     Background: Embryo quality is known to be a very important determinant to predict the~     implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or~     endometrial receptivity cannot be overlooked.~      Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of~     plasma cells in the endometrial stroma. There is not only no census on the definition of CE,~     the current literature on the impact of CE on reproductive outcome is controversial and~     consists only of retrospective studies with small sample sizes. Although there is a~     presumption that CE is related to poor IVF outcome, this belief has not been proven.~      Design: Prospective cohort study~      Setting: Infertility clinics of 2 academic medical centers~      Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF~     cycle will be invited to participate.~      Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks~     estimated gestational age (EGA) with previously documented fetal cardiac motion. Secondary~     outcomes will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or~     loss of fetal cardiac motion before 12 weeks EGA.~      Materials and Methods: The cycle prior to IVF, patients will undergo an in-office~     endometrial biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of~     plasma cells will be quantified. The number of plasma cells in a sample that yields the best~     sensitivity and specificity for pregnancy will be determined by a Receiver-Operator-Curve.~     This number will then be used as a dichotomous variable to assign categories of positive~     for CE and negative for CE. Pregnancy and miscarriage rates will then be determined in~     the positive and negative CE sample with Chi Square Analysis. A secondary sub analysis will~     be performed to determine pregnancy and miscarriage rates in patients who declined to~     participate in the study.~      Expected Results: The investigators hypothesize that higher rates of CE will be found in~     women failing to conceive with IVF and with subsequent first-trimester miscarriage.~   "
31338|NCT02646917|"~     This single-center, clinical trial will take place over a 90 day course followed by 1-month~     and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen~     device when used on both men and women on the face and/or back.~   "
31339|NCT02646904|"~     The purpose of this study is to examine in children with persistent AR the effect of the~     topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by~     acoustic rhinometry and subjective nasal symptoms.~   "
31340|NCT02646891|"~     This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus~     vaccine). The study will examine the safety and immunogenicity of three dose levels of this~     vaccine in healthy South African adults, toddlers and infants. Progression from one dose~     level to another and to the next age group population will be based on the assessment of~     safety information from the lowest dose and older age group.~      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and~     well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit~     rotavirus vaccine is immunogenic in infant participants and will induce an immune response~     to at least 2 of the 3 strains in 60% or more of participants in at least one of the study~     groups.~   "
31341|NCT02646878|"~     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in~     subjects age 14 - 75 years.~   "
31342|NCT02646865|"~     This study evaluates the addition of a self-compassion training in the treatment of social~     anxiety disorder. Half of the participants will receive a self-compassion enhanced group~     cognitive-behavioral therapy, while the other half will receive standard group~     cognitive-behavioral therapy.~   "
31343|NCT02646852|"~     This is a Phase I, two-stage, open-label, single-arm, dose escalation study of DFP-13318~     intravenous infusion administered to patients with refractory or relapsed solid tumors. This~     study will explore two different dosing schedules- once every 3 weeks (q3w) and once every 2~     weeks (q2w) - during Stage 1 and Stage 2, respectively.~   "
31344|NCT02646839|"~     This is a phase II, open-label, non-randomized, prospective study of haploidentical~     transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia~     (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic~     hematopoietic cell transplantation (HCT). The relationship of KIR2DL1 polymorphisms to~     survival in children with these diseases undergoing any approach to allogeneic HCT during~     the study time frame will also be determined.~   "
31345|NCT02646826|"~     This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral~     administration of one of three dose levels of Paxerol or placebo in subjects with nocturia.~     Eligible study subjects will be identified according to inclusion/exclusion criteria (see~     below), and baseline assessments will be recorded.~      Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding~     trial, stratification according to gender and BMI will be difficult. However, similar~     distribution of patient types to the four treatment groups will be attempted by evenly~     assigning patients to the four treatment groups according to genders and body mass index~     (BMI) of <25, 25-30 and 30-40.~      Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia~     frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS),~     total hours of nightly sleep, safety and tolerability will be monitored before and after a~     two-week treatment period. Results from subjects treated with different doses of Paxerol and~     placebo will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production~     will also be assayed to assess potential correlation between baseline urinary PGE2~     production and responsiveness to Paxerol treatment.~   "
31351|NCT02646748|"~     This is an open-label, Phase 1b, 3 Part (Part 1a, Part 1b and Part 2), multi-center study.~      Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced~     solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib~     (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a~     PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum~     tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each~     combination.~      Once the recommended dose has been identified in Part 1a, subjects with select solid tumor~     types will be enrolled into safety expansion cohorts based upon prior treatment history with~     a PD-1 pathway-targeted agent (Part 1b) for each combination.~      Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with~     pembrolizumab in patients with small cell lung cancer (SCLC).~   "
31352|NCT02646735|"~     A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be~     randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.~   "
31353|NCT02646722|"~     Rocuronium results in burning pain on injection site. It can be reduced by local anesthetics~     or opioid, but still some patients, especially in children, show withdrawal movement for~     pain. This might resulted from individual pain sensitivity.~      Emergence agitation (EA) in children is quite frequent postoperatively and is known to be~     associated with postoperative pain. If a patient is susceptible to postoperative pain, he or~     she would have high probability of EA postoperatively. Therefore, the investigators explore~     the relation of withdrawal movement of rocuronium and EA.~   "
31354|NCT02646709|"~     Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40~     minute after single bolus injection. For outpatient surgery with short operation time, low~     dose rocuronium is frequently used for rapid recovery at the expense of compromised~     intubating condition. For better intubating condition, ketamine can be used. However,~     appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3~     different doses of ketamine with low dose rocuronium will be compared for appropriate~     intubating condition.~   "
31355|NCT02646696|"~     The purpose of this study is tTho establish test-retest reliability of electrodermal markers~     used to quantify physiologic response to sensation using the Sensory Challenge Protocol in~     children with and without Autism Spectrum Disorder (ASD).~   "
31356|NCT02646683|"~     This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 130~     patients with 'early CD' defined as disease duration < 24 months and no other treatments~     than corticosteroids and 130 patients with 'late CD' defined as active disease despite~     treatment with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF~     will also be allowed in the latter group. Participants will be treated with 12 months of~     open label vedolizumab (study medication followed by commercial medication once~     reimbursement is available) and undergo monitoring of endoscopic, histological and clinical~     disease parameters. No randomization or blinding will be performed but the study management~     will ensure that recruitment in either study group is comparable for number and profile of~     patients (on/off steroids).~   "
31357|NCT02646670|"~     The purpose of this study in to compare the efficacy of treatment of diabetic macular edema~     (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus~     Ranibizumab (Lucentis®).~      It is a randomized clinical trial that will evaluate the efficacy of the combination of two~     substances currently used in the treatment of DME. Will be allocated in different four~     groups randomly pacients who receive treatment with intravitreal injections of ranibizumab,~     aflibercept or a combination of aflibercept and ranibizumab.~   "
31358|NCT02646657|"~     This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60~     patients with 'early UC' defined as disease duration < 4 years and no other treatments than~     aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active~     disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih~     intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will~     be treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic,~     histological and clinical disease parameters. No randomization or blinding will be performed~     but the study management will make sure recruitment in either study group is comparable for~     number and profile of patients (extent of disease and on/off corticosteroids).~   "
31359|NCT02646644|"~     In an individual cancer patient extensive genetic and phenotypic variation exists between~     and within tumor lesions. Tumour load in NET patients can be measured with~     fluorine-18-L-dihydroxyphenylalaninepositron emission tomography (18F-DOPA-PET) scan.~      This aim of the study is to investigate heterogeneity between tumor lesions within patients~     with intestinal NET by determining the differences in tracer uptake measured on a 18F-~     DOPA-PET scan retrospectively.~   "
31360|NCT02646631|"~     The long-term goal of this research is to improve seizure control among patients with~     epilepsy, which has the potential to improve quality of life for thousands of people living~     with epilepsy and reduce health care utilization, social and economic costs, and~     epilepsy-related mortalities. Participants who are suffering from epilepsy will be~     randomized to receive usual care (UC), a smartphone-based self-management intervention~     called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational~     interviewing (MI). Participants will be followed for 3 months.~   "
31361|NCT02646618|"~     The present study is a non-inferiority trial comparing the efficacy of a lifestyle~     intervention delivered entirely via an online social network to a traditional lifestyle~     intervention delivered via group meetings.~   "
31362|NCT02646605|"~     Quantitative, validated tools of depression screening will be used to collect data to~     determine the prevalence of depression and its association with antiretroviral (ARV)~     adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.~   "
31363|NCT02646592|"~     This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in~     children under general anesthesia, before skin incision.~   "
31364|NCT02646579|"~     The purpose of this study is to determine if dry needling both low back and extremity areas~     is more effective for reducing pain and improving strength, balance and functional~     performance among patients with chronic musculoskeletal conditions compared to dry needling~     of extremity areas only.~   "
31366|NCT02646553|"~     Cortisol overproduction ( Cushings syndrome) is a condition where the patient have a special~     fat distribution, with accumulation of fat around the abdomen and in the neck, with thinner~     limbs and weak musculature. The condition can be difficult to separate from adipositas in~     general. Screening for hypercortisolism in adults has been easier the last years, because we~     can measure free cortisol in saliva samples at late night. In children we still dont have~     reference ranges for saliva cortisol in children, so the screening is still troublesome,~     based on Collection of 24-hour urine.The meaning of this study is to establish reference~     ranges for saliva cortisol, and evaluate in a cohort with adipose children if screening with~     saliva cortisol is sensitive and specific enough to be the New screening test for~     hypercortisolism in children too.~   "
31367|NCT02646540|"~     The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when~     given in addition to intravenous (IV) diuretics early during an episode of acute heart~     failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone~     in addition to IV diuretics. The investigators are looking to see if there is improvement in~     the symptoms and outcomes of persons with acute heart failure.~   "
31368|NCT02646527|"~     Background: There has been significant progress in symptom management, pain relief and~     improvement of quality of life in patients nearing death by implementing palliative care~     programs. Existential and dignity related issues, such as loss of autonomy and sense of~     meaning or feeling a burden to others are frequent reasons for psychological distress and~     desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief,~     individualized psychotherapy for the purpose of relieving distress by directly addressing~     dignity conserving factors.~      Aims: To test whether the inclusion of a patient's partner or designated family member into~     Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in~     both, the patient nearing the end of his life experiencing increased psychological distress~     and the patient's partner/family member compared to the control groups receiving Dignity~     Therapy in the single setting (DT) or standard palliative care (SPC).~      Methods and design: In this randomized controlled trial a total of 159 patients with a~     diagnosis of an advanced disease and poor prognosis (life expectancy < 6 months) who receive~     palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ)~     or the Clinic Susenberg, Zurich, or in the Lighthouse Hospice Zurich, will be randomly~     assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and~     included if they report increased psychological distress (anxiety, depression using the~     Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and~     consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients~     to reflect on their most important achievements, roles or other things in their lives or~     things that they would most want remembered. On completion, the audiorecording is~     transcribed and edited to provide a clear and readable narrative, the generativity document,~     which can be passed to a person of the patient's choice. DT+, in contrast to the original~     intervention developed by Chochinov et al., is a systemic approach in which patient's~     partners or designated family members are included.~   "
31369|NCT02646514|"~     Malignant obstructive jaundice is a common complication of advanced stage~     cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by~     malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for~     palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS~     present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more~     cost-effective than plastic stents in patients with a life expectancy of longer than 4~     months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of~     patients in the first 6-8 months.~      Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the~     early 1990s. Other studies have investigated its role in diseases of the colon and~     esophagus. More recently, this technique has been recognized for its potential in palliative~     treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to~     generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile~     duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and~     tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the~     other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south~     korea, recently.~      The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by~     using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage~     in patients with malignant biliary strictures.~   "
31370|NCT02646501|"~     The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in~     patients with recurrent sustained VT/VF in spite of appropriate medical therapy and~     cardio-version/ defibrillation after correction of underlying correctable factors with those~     without PSGB by prospective randomized trail. PSGB will be performed every 3 days by~     anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We~     will compare the frequency and episode number of VT/VF, procedure related complication,~     acute and long-term mortality.~   "
31371|NCT02646488|"~     The primary purpose of this study is to evaluate the effectiveness of practice facilitation~     as a quality improvement strategy for implementing the Million Hearts' ABCS treatment~     guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive~     care in primary care practices in New York City. The ABCS refer to the following: Aspirin in~     high-risk individuals (A), Blood pressure control and management (B), Cholesterol management~     (C), and Smoking cessation (S). The long-term goal is to create a robust infrastructure to~     disseminate and implement evidence based practice guidelines (EBPG) findings in primary care~     practices and improve practices' capacity to receive and implement other EBPG findings in~     the future.~   "
31372|NCT02646475|"~     The overall purpose of this study is to learn more about the metabolic effects of~     angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic~     approaches to increase angiotensin-(1-7) levels or its actions are currently in development~     for treatment of metabolic-related diseases such as obesity and type II diabetes, based on~     findings from animal studies. It is unclear if this peptide contributes to the regulation of~     metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve~     insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals~     with obesity and insulin resistance. The investigators will also examine for changes in~     blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7)~     infusion.~   "
31373|NCT02646462|"~     Prospective investigation of the ratio between malignant and total number of lymph nodes in~     predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A~     national Danish project.~   "
31435|NCT02645656|"~     Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived~     from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the~     Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to~     Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised~     of curcumin, demethoxy curcumin and bisdemethoxycurcumin.~   "
31374|NCT02646449|"~     Recent reports have shown that alcohol misuse is a particularly serious problem among the 18~     to 25 year old age group. Previous medication trials with SSRI antidepressants among young~     adults with co-occurring depressive disorders, including our own recent trials with SSRI~     medications, have produced disappointing results, especially for decreasing the level of~     alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and~     mechanism of action. Recent study results suggest that mirtazapine is more effective than~     other antidepressants for treating non-comorbid depression. A few recent studies with~     mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have~     demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol~     craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of~     alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use~     of that comorbid population. The results of our own very recent open label pilot study~     suggest robust within-group efficacy for mirtazapine for decreasing both the level of~     alcohol use and the depressive symptoms of comorbid subjects. However, that pilot study did~     not include a placebo control group, so the efficacy of mirtazapine versus placebo for~     decreasing the level of alcohol use among persons with comorbid AUD/MDD remains unclear.~     This grant submission proposes to conduct a first double-blind, placebo-controlled pilot~     study to provide a preliminary assessment of the efficacy of mirtazapine versus placebo for~     decreasing both the alcohol use and depressive symptoms of young adults with comorbid~     AUD/MDD. If results (effect sizes) from the proposed study are found to be promising~     concerning outcome differences between the mirtazapine and placebo groups, then we will use~     those findings to apply for an R01 study to definitively assess the efficacy of mirtazapine~     for treating young adults with AUD/MDD.~   "
31375|NCT02646436|"~     Peritoneal dialysis (PD) has become a well-established complementary alternative to~     haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu~     Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are~     started urgently on chronic dialysis due to late referral or unexpected deterioration of~     residual renal function. These patients, although suitable for PD, were previously started~     on HD using central venous catheter. Since July 2014 patients have been offered urgent start~     on chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger~     technique. The main objective is to compare technique and patients survival on unplanned PD~     vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will~     describe how acute PD will initiated using high volume PD until metabolic and fluid control~     right after (<48 h) PD catheter placement standard prescription for a 12 h overnight~     automatic PD until hospital discharge and intermittent PD at dialysis unit family training.~   "
31376|NCT02646423|"~     Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly~     one third of births annually. In the last decade, the CD rate has increased by approximately~     50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been~     associated with an increase in major maternal morbidity (Silver 2010), with corresponding~     increases in length of inpatient care following delivery and frequency of hospital~     readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American~     College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse~     Midwives have targeted reducing the CD rate as an important public health goal for more than~     a decade; however, identifying interventions to achieve this goal has proven challenging.~      Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the~     combination of a rising rate of primary CD and a decreasing rate of vaginal birth after~     cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010~     (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of~     debate; the extent to which these changes are driven by patient preferences is not known. An~     NIH consensus conference statement noted that the informed consent process for TOLAC and~     Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and~     incorporate a strong emphasis on the values and preferences of pregnant women, and~     recommended interprofessional collaboration to refine, validate, and implement~     decision-making and risk assessment tools to accomplish that goal (Cunningham 2010).~      Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to~     help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer~     TOLAC consider individualized risk assessments, incorporate their values and preferences,~     and participate in a shared decision making process with their providers to make informed~     decisions about delivery approach. We are now conducting a randomized study of the effect of~     a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.~   "
31377|NCT02646410|"~     Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy~     for malaria control in countries with seasonal malaria transmission such as Mali in March~     2012. The goals are to identify the most effective method to deliver SMC, and to obtain more~     information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to~     determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly~     observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC~     delivery; 2) to compare quantitative measures of immunity in children who do and do not~     receive SMC. A cluster-randomized design will be sued. The target population will be~     children aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four~     sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT).~     The optimal mode of delivery will be selected based on the SMC coverage during the first~     year, and will then be implemented in villages of two additional sub-districts. Villages in~     these two newly selected sub-districts will be randomized in two groups. Children in the~     first group will received three rounds of SMC and those in the second group will receive~     four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of~     clinical malaria as measured by passive surveillance. In Year 3, children in the selected~     sub-districts will received SMC by the optimal delivery system determined in Years 1 -2.~   "
31378|NCT02646397|"~     The purpose of this study is to compare the effect of fosinopril plus benidipine vs.~     fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in~     CKD patients with HTN.~   "
31379|NCT02646384|"~     The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue~     cryopreservation to female pediatric patients (birth-17 years of age) with fertility~     threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may~     cause loss of reproductive potential. Because this procedure is currently considered~     experimental, the establishment of an IRB protocol under which this opportunity can be~     offered is needed.~   "
31380|NCT02646371|"~     In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will~     be tested for its ability to induce an immune response that protects healthy adult~     volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects~     receiving placebo.~   "
31381|NCT02646358|"~     This is an open-label study designed to evaluate the effect of renal disease on the~     pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with~     normal renal function.~   "
31382|NCT02646345|"~     Limited information is available about surgical checklist effectiveness in Latin America. We~     plan to compare the pre and post surgical checklist implementation in a tertiary healthcare~     center in terms of morbidity (length of stay and surgical site infection rate) and~     in-hospital mortality rate.~   "
31383|NCT02646332|"~     Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains~     unanswered.~   "
31384|NCT02646319|"~     This pilot phase II trial studies how well nanoparticle albumin-bound rapamycin works in~     treating patients with cancer that as has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced cancer) and that has an abnormality~     in a protein called mechanistic target of rapamycin (mTOR). Patients with this mutation are~     identified by genetic testing. Patients then receive nanoparticle albumin-bound rapamycin,~     which may stop the growth of cancer cells by blocking the mTOR enzyme, which is needed for~     cell growth and multiplication. Using treatments that target a patient's specific mutation~     may be a more effective treatment than the standard of care treatment.~   "
31385|NCT02646306|"~     The aim of the study focused on the creation of a rehabilitative measuring device~     (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination~     methodology for assessing the proprioception of the glenohumeral joint respect to scapula~     abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects~     and in patients with shoulder impingement syndrome.~   "
31386|NCT02646293|"~     The incidence of the diagnosis of renal cell carcinoma has increased during the past two~     decades because of the detection of small renal tumours that occur incidentally because of~     increased use of CT-scanning (1,2). Postoperative renal insufficiency was a significant~     independent predictor of overall and cardiovascular specific survival (3). Nephron-sparing~     surgical techniques are now preferred for small tumor masses and laparoscopic intervention~     is replacing open surgery at centers that master this technique. This is an area of priority~     within the Regions of Zaeland and Southern Denmark.~      The primary endpoint is:~      The early plasma (5 days) [NT-proBNP] response predicts long-term total renal function and~     function of the remaining kidney.~      The second endpoint:~      Plasma [NT-proBNP] increases acutely after partial nephrectomy and the change reflects the~     renal mass reduction.~      Chronic blood pressure change is inversely related to plasma [BNP].~   "
31387|NCT02646280|"~     The purpose of the study is to determine the effectiveness of an approach that combines~     massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the~     words of the physiotherapist compared to a traditional massage therapy in reducing pain in~     patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is~     linked to the interoceptive awareness and which is the patient's ability to relax through~     the measurement of the hearth rate variability (HRV).~   "
31388|NCT02646267|"~     The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate~     and different intensity warfarin for the prevention of stroke and systemic embolism in~     patients with non-valvular atrial fibrillation.~   "
31389|NCT02646254|"~     Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot~     repair: a randomized study of Two cardioplegic techniques.~   "
31390|NCT02646241|"~     To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are~     required. It is difficult to obtain adequate tissue samples. There were several biopsy~     methods to obtain tissue samples. Pathological examination would include mitosis counts,~     particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric~     wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal~     tumor (GIST) of malignant potential is essential.~      So We hypothesize that unroofing biopsy is an more appropriate method than~     EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic~     accuracy and complications between EUS-FNB & unroofing biopsy.~   "
31391|NCT02646228|"~     With rapid advances in molecular oncology, the availability of preclinical in vitro cell~     models and in vivo animal models with specific genomic aberrations is critical for improved~     prediction of clinical outcomes in cancer patients. One of the most widely used preclinical~     models is conventional cell lines, such as the NCI-60 panel of cell lines;these cell lines~     are widely used in preclinical testing for novel targeted drugs, partially owing to the low~     expense and reduced labor associated with cell culture compared with other preclinical~     models, such as animal xenografts. However, recent studies have shown that accumulation of~     genetic aberrations in cancer cell lines occurs with increasing passage number. These models~     also lack the heterogeneity of tumors and do not exhibit a proper microenvironment,~     highlighting the limitations of cell-based models. Consistent with this, Johnson et al.~     demonstrated that in vivo activities of the cell lines within the NCI-60 panel did not~     closely correlate with corresponding human cancers.~      Therefore, to better preserve the genomic integrity and tumor heterogeneity observed in~     patients, patient-derived xenograft (PDX) models are being used more frequently. PDX is~     generated by directly transplanting freshly resected patient tumors into immunocompromised~     murine hosts with or without an intermediate in vitro culture step. This PDX model is an~     improvement over cell lines because it can provide both an appropriate tumor~     microenvironment and heterogeneity of tumor cells. However, the engraftment success rates~     and growth rates of implanted tumors are highly variable depending on the tumor type,~     possibly due to insufficient numbers of hematopoietic cells and/or ineffective~     microenvironmental cues in the mouse stroma. The extent to which tumor cells from freshly~     resected tumors are able to withstand mechanical stresses and xenotransplantation barriers~     is also unclear. Furthermore, the use of PDX models for application in clinical oncology is~     limited owing to the time required for PDX establishment (> 4 months) since most patients~     with refractory cancer live less than 1 year. Recently, PDC line models have been suggested~     as an alternative preclinical model to be used as a prediction tool for preclinical drug~     sensitivity.~      Therefore, in this study, the investigators aimed to overcome these potential barriers of~     pre-existing models by examining the capacity of PDC line models to recapitulate the~     histological and genomic features of primary patient tumors. In selected cases, the~     investigators screened drug sensitivity in vitro using PDC lines and compared the results~     with real-life clinical treatment outcomes.~   "
31392|NCT02646215|"~     Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients~   "
31393|NCT02646202|"~     Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro~     esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation~     are very effective in controlling acute esophageal varices bleeding and preventing~     rebleeding.~   "
31394|NCT02646189|"~     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral~     activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have~     potent therapeutic effect against established DHBV infection in vivo~      REP 2055 was additionally shown to have significant antiviral effects in patients with~     chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055~     designed for improved administration tolerability and stability.~      The safety and antiviral activity REP 2139, first in monotherapy and then in combination~     with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102~     protocol.~   "
31436|NCT02645643|"~     The doctor-patient relationship was becoming worse. More and more work-related violence has~     happened to physicians and nurses. A portion of medical students felt depressed and thought~     that the career future was gloomy. The study was designed to measure the empathy, an vital~     element of professionalism, well-being of mental and study emotion. Furthermore, the~     investigators explored an intervention of group study to promote medical students'~     professionalism, mental health and study emotion.~   "
31395|NCT02646176|"~     Traumatic brain injury (TBI) is increasingly recognized as a significant public health~     issue, but the most effective rehabilitation methods have yet to be identified. The~     Institute of Medicine and the Agency for Healthcare Quality and Research sponsored~     systematic reviews of evidence for comparative effectiveness of rehabilitation interventions~     for TBI. Both reviews concluded that substantially more research is needed to identify~     interventions best suited for different individuals. The practice-based evidence (PBE)~     approach employed to create the data used in the proposed study was a research method~     recommended to provide greater clarity, along with use of patient-centered outcomes obtained~     over a longer period of time than used in previous studies.~      The following specific aims will be addressed in the proposed study:~        1. Determine the comparative effectiveness of different therapeutic approaches used in~          inpatient TBI rehabilitation after statistically adjusting for patient need and ability~          to benefit from various approaches.~           Investigators hypothesize:~           1.1. Patients who receive a greater proportion of therapy time in Advanced Training~          (versus Standard of Care) will achieve better outcomes than similar patients who~          receive a lesser proportion of treatment time in Advanced Training.~           1.2. Patients with the greatest initial levels of disability will experience larger~          effects from Advanced Training therapeutic approaches in comparison to the effects~          experienced by patients with less disability at admission.~           1.3. Patients who receive a greater proportion of therapy in contextualized treatment~          (versus decontextualized) will achieve better outcomes than similar patients who~          receive a lesser proportion of time in contextualized treatment.~        2. Determine the comparative effectiveness of difference in the delivery of inpatient~          rehabilitation therapies, after statistically adjusting for patient need and ability to~          benefit.~      Investigators hypothesize:~      2.1 The level of effort that patients are able to apply in treatment moderates the~     effectiveness of time in treatment.~      2.2 Family involvement in treatment is associated with better outcomes.~      Data will be drawn from the database established for the TBI Practice-Based Evidence Study~     (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10~     sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were~     collected prospectively on rehabilitation therapies (with point of care data completed for~     every clinical encounter), course of recovery, person and injury characteristics and~     outcomes during and after rehabilitation. Advanced analytic methods (e.g. propensity scores,~     generalized linear mixed models) will be used to compare the effects of different~     rehabilitation interventions on outcomes at discharge and during the 9 months following~     rehabilitation.~   "
31396|NCT02646163|"~     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C~     virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV)~     infection. REP 2055 has been shown to have potent prophylactic effect against HCV infection~     in vivo and potent therapeutic effect against established DHBV infection in vivo~      The REP 101 protocol is the first-in-man proof of concept study designed to investigate the~     safety and antiviral activity of REP 2055 administration in human patients with chronic HBV~     or HCV infection.~   "
31397|NCT02646150|"~     This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging~     to qualitatively assess adequate distal perfusion after endovascular revascularization in~     Critical Limb Ischemia~   "
31398|NCT02646137|"~     Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In~     recent years, transarterial chemoembolization, radio frequency ablation and microwave~     ablation have been accepted as treatment modalities for patients with surgically~     unresectable hepatocellular carcinoma.~   "
31399|NCT02646124|"~     Low back pain (LBP) causes 2.4% of visits to US emergency departments (ED) resulting in 2.7~     million visits annually. In general, outcomes for these patients are poor. One week after ED~     discharge, 70% of patients report persistent back-pain related functional impairment and 69%~     report analgesic use within the previous 24 hours. Three months after the ED visit, 48% of~     these patients report functional impairment, 42% report moderate or severe pain, and 46%~     report persistent analgesic use.~      It is not clear how acute LBP should be treated. Non-steroidal anti-inflammatory drugs~     (NSAID) are guideline-supported, first line therapy for acute LBP. NSAIDs are more~     efficacious than placebo with regard to pain relief, global improvement, and requirement of~     analgesic medication but are not sufficient therapy for as many as ½ of ED patients, who~     continue to suffer despite therapy with NSAIDs. Treatment of LBP with multiple concurrent~     medications is common in the ED--emergency physicians often prescribe benzodiazepines,~     skeletal muscle relaxants, or opioids in combination with NSAIDs. However, work recently~     completed here at Montefiore has revealed that combining skeletal muscle relaxants or~     opioids with NSAIDs does not improve outcomes. It remains uncertain if adding~     benzodiazepines to NSAIDs improves LBP outcomes.~      Although benzodiazepines are used in 300,000 US ED visits for LBP annually, scant evidence~     exists to determine the appropriateness of this approach. Efficacy of benzodiazepines may be~     related to direct or centrally-mediated action on skeletal muscle or may instead work by~     mitigating anxiety about the condition or numbing a patient to the pain.~      Given the poor pain and functional outcomes that persist beyond an ED visit for~     musculoskeletal LBP, we propose a clinical trial to evaluate whether combining a~     benzodiazepine with an NSAID is more effective than NSAID monotherapy for the treatment of~     acute, non-traumatic, non-radicular low back pain. Specifically, we will evaluate the~     following hypothesis:~      A daily regimen of naproxen + diazepam will provide greater relief of LBP than naproxen +~     placebo one week after an ED visit, as measured by the Roland Morris Disability~     Questionnaire.~   "
31400|NCT02646111|"~     The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie~     adults with chronic hepatitis C virus (HCV), who have not responded to prior treatment~     with protease inhibitors.~      The Triple therapy of AbbVie attacks various sites of the viral genome, thus increasing~     the potential efficacy of the treatment, especially for patients who have failed PI~     treatment.~   "
31401|NCT02646098|"~     Primary objective:~      To assess the differences in the overall survival at 3 years of a CD34+ cell selection~     versus no selection of hematopoietic progenitor cells harvested during peripheral blood stem~     cell collection before high-dose chemotherapy with autologous stem cell transplantation~     (ASCT) in advanced stage mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL)~     patients.~      Secondary objectives:~      To assess differences in disease-free survival between CD34+ cell selection versus no~     selection of hematopoietic progenitor cells harvested during peripheral blood stem cell~     collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in~     advanced stage mantle cell (MCL) or in diffuse large B-cell lymphoma (DLBCL) patients.~      To compare hematologic engraftment and the time needed until hematologic recovery after ASCT~     using CD34+ selected or unselected autologous stem cell grafts.~      To compare infectious complications, particularly CMV infections, observed until 100 days~     after ASCT comparing CD34+ selected or unselected autologous stem cell grafts.~      To assess the response rate at day 100 after ASCT in advanced stage mantle cell lymphoma~     (MCL) or diffuse large B-cell lymphoma (DLBCL) patients after ASCT comparing patients with~     CD34+ cell selection versus no selection.~      To assess the total time needed for the apheresis procedure and the number of apheresis days~     needed to ensure the collection of a sufficient number of autologous stem cells comparing~     patients with CD34+ cell selection versus no selection.~      To assess the need for the additional use of G-CSF (Neupogen) and of the stem cell releasing~     compound Plerixafor (Mozobil) to ensure the collection of a sufficient number of autologous~     stem cells comparing patients with CD34+ cell selection versus no selection.~      Outcome(s):~      The aim of the study is to show ≥ 15% better 3-year overall survival of lymphoma patients~     having received CD34+ cell selection during autologous stem cell collection before~     autologous stem cell transplantation compared to no CD34+ cell selection.~   "
31402|NCT02646085|"~     Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography~     imaging with intravenously injected C11 Methionine to detect viable lesions.~   "
31403|NCT02646072|"~     The purpose of this study is to determine whether there is a relationship between~     inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment~     of topical ketorolac for patients undergoing cataract surgery.~   "
31404|NCT02646059|"~     Blood donor recruitment is an important issue in every country, since the blood supply~     pressure become more and more intense. Donor retention is even more important, because it is~     easier to recruit an old customers than a new one. Therefore, figuring the most effective~     ways of recruiting lapsed blood donors and understanding the reasons of not donating blood~     again is critical and vital for the development of blood donation.~   "
31405|NCT02646046|"~     Investigators designed the novel combining technique that rescuer start the chest~     compression with one hand during calling for help to the Emergency Medical System (EMS) via~     a cell phone with another hand when he witnessed the arrest victim. This method may be~     helpful to reduce the hand-off time and increase the faction time of chest compression until~     the arrival of EMS members.~      To verify this hypothesis, we conducted a random, controlled simulation study.~   "
31406|NCT02646033|"~     This study analyse the rise in Intraocular Pressure while patient is in surgery in head low~     position.~   "
31407|NCT02646020|"~     Study hypothesis is that aprepitant is more effective than desloratadine in relieving~     pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective~     treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to~     baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe~     pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, first or~     seconde generation TKIs, VAS 4-6 or 7-10) randomized (1:1) into aprepitant or desloratadine~     treatment. VAS investigation will be taken once a week to treatment end or follow-up end~     (≤12 weeks).~   "
31408|NCT02646007|"~     Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is~     usually progressive without treatment.~      Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells~     are the best candidates for this kind of treatment.~      This study examined lunate core decompression in combination with implantation of autologous~     bone marrow derived mesenchymal stromal cells for Its treatment potential.~      Bone decompression in combination with implantation of autologous bone marrow derived~     mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.~      The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.~      The Spss(v16) software will be used for data analysis.~   "
31409|NCT02645994|"~     Advancement in techniques for anaesthetic drug delivery and real time monitoring has~     facilitated safe induction and maintenance of anaesthesia in severely compromised patients.~     Cardiac diseases are the commonest causes of morbidity and left ventricular failure is the~     commonest clinical presentation at the end stage. LV systolic dysfunction is defined as~     reduction in LVEF ≤55%. Patients with LVEF 55%-46% have mild, 45%-36% moderate and ≤35%~     severe LV systolic dysfunction. Patients with heart failure have a diminished cardiac~     reserve capacity that may be further compromised by anaesthesia. In addition to depression~     of sympathetic activity, most anaesthetics interfere with cardiovascular performance, either~     by a direct myocardial depression or by modifying cardiovascular control mechanisms.~     Propofol with fentanyl is advocated as the best anaesthetic combination for induction of~     anaesthesia in patients undergoing CABG. Propofol is a drug with narrow therapeutic index~     and may cause severe hypotension and hemodynamic instability during induction of~     anaesthesia, especially if it is given in too large doses.~      Automated drug delivery systems are popular for delivery of propofol. They can be of two~     types, depending on whether they are based on pharmacokinetic or pharmacodynamic principles.~     Closed Loop Anaesthesia Delivery system has been used world-wide and in our institute in~     patients of various age groups and in patients undergoing cardiac surgery. But still the~     studies are lacking in patients with moderate to severe left ventricular systolic~     dysfunction. Moreover none of the studies have compared the efficacy of anaesthetic drug~     delivery using these two devices in this group of patients.~      Thus there is paucity of literature regarding PK and PD of propofol in patients with cardiac~     failure. The investigators hypothesized that as the Closed Loop Anaesthesia Delivery System~     is based on pharmacodyanamic principles, it should perform better than the Target Control~     Infusion system, which works on pharmacokinetic principles. The investigators planned to~     conduct this study to determine the anaesthetic depth control using Closed Loop Anaesthesia~     Delivery system vs. manual control using Target Controlled Infusion in patients with~     moderate to severe left ventricular systolic dysfunction.~   "
31410|NCT02645981|"~     Donafenib versus sorafenib for advanced hepatocellular cancer.~   "
31411|NCT02645968|"~     The purpose of this study is to collect valid data from all forms of health care on the~     incidence, prevalence, the regional distribution, characteristics, management and outcomes~     of different ILDs under clinical practice conditions.~   "
31412|NCT02645955|"~     Primary Purpose:~        1. Evaluate the prevalence and incidence of HEV infection in MHD patients.~        2. Compare differences of the prevalence and incidence between the MHD patients and the~          control. .~      Secondary purpose:~      Analyze risk factors of HEV infection.~   "
31413|NCT02645942|"~     The investigators designed this intervention to investigate the potential role of L-C in~     lipid and carbohydrates metabolism (primary outcome) with precision noninvasively~     measurement of: central blood pressure, pulse wave velocity and peripheral arterial~     stiffness (secondary outcome) in OSA patients.~   "
31414|NCT02645929|"~     Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder~     (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of~     action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to~     trauma reminders. This assessment study will assess Symptom-Specific Reflective Function, a~     measure of emotional awareness of one's PTSD symptoms, as a potential mediator of IPT,~     capitalizing on naturalistic treatment of military veterans with PTSD at Columbia~     University/New York State Psychiatric Institute.~   "
31415|NCT02645916|"~     The Purpose of this trial is to investigate the efficacy and safety of~     Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity~     in the Hands~   "
31416|NCT02645903|"~     Living donor organ transplantation has increased in recent years due to an increased need~     for organs. The objective of this study was to investigate the effects of a TAP block on~     postoperative analgesia and opioid consumption in liver transplantation donors in whom a~     right lateral extending upper mid-line abdominal incision was used.~   "
31417|NCT02645890|"~     The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397~     in healthy male volunteers.~   "
31418|NCT02645877|"~     This was a retrospective analysis of a cohort of all emergency care patients in Beijing from~     January 2005 to December 2014. This aim of this study was to analyze the trends in~     pre-hospital emergency care need and the emergency response times, with the intention of~     aiding the government to optimize medical resources and improve pre-hospital emergency care.~   "
31419|NCT02645864|"~     Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal~     squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from~     that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant~     pathological type in China and account for more than 95% cases in clinic. The prognosis of~     ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year~     survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse~     in many patients.~      For patients with unresectable or recurrent disease, chemotherapy is an important treatment~     alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported~     effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is~     still no standard 2nd-line treatment for patients who fail in first-line treatment. Both~     irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients.~     But there are only a few of ESCC patients involved in those studies.~      Except for chemotherapy, targeting treatment is another promising treatment for esophageal~     cancer. In recent years, antiangiogenic treatment has been proved to be effective and~     tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also~     known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has~     shown that it is effective in the treatment of a variety of solid tumors including~     esophageal cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment~     for patients with advanced gastric cancer.~      Therefore, investigators initialize this dose escalation phase I study to explore the safety~     of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after~     esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum~     tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.~   "
31577|NCT02643771|"~     The purpose of this study is to determine whether periodontal treatment improves the~     periodontal clinical parameters in the periodontal patients with diabetes regarding~     non-diabetics: two years follow-up.~   "
31420|NCT02645851|"~     Rapid volume expansion using repeated intravenous fluid boluses is a very common~     intervention performed in the intensive care unit (ICU) in the early days of resuscitation~     of patients with shock. Once passed the initial phase of resuscitation, the fluid boluses~     administered fail to effectively increase the patients' cardiac output in about 50% of~     cases. Pulse pressure changes or stroke volume changes induced by a Passive Leg Raising~     (PLR) test have acceptable/good ability to predict fluid responsiveness (in terms of cardiac~     output change) and may be systematically used in patients with persistent shock with the aim~     of limiting the total amount of fluid administered to patients by avoiding undue fluid~     boluses. One may suppose that such a volume expansion management policy could impact~     morbidity and mortality of shocked patients. Among the predictive indices available in~     clinical practice, the PLR test has the advantages of being usable regardless of the~     patients' respiratory status and cardiac rhythm. Changes in left ventricular stroke volume~     during the PLR test perform better that changes in pulse pressure to predict fluid~     responsiveness. However, in counterpart, pulse pressure changes during PLR can be assessed~     without the need of other hemodynamic exploration such central venous pressure measurement~     or cardiac output monitoring. The investigators hypothesized that strategies using either~     stroke volume changes or pulse pressure changes induced by the PLR test to decide wether a~     fluid bolus clinically deemed indicated should or should not be administered, may limit the~     amount of fluid received by the patients during the first 5 days of shock, improve their~     oxygenation index, and shorten the time passed under mechanical ventilation, as compared to~     a liberal strategy (usual care) that does not use predictive indices of fluid~     responsiveness.~   "
31421|NCT02645838|"~     The purpose of this study is to determine whether or not motivational interviewing is~     effective in smoking cessation at general practice setting in China.~   "
31422|NCT02645825|"~     Investigators need to establish a formal diagnostic of superficial adenopathy through~     complementary investigations to find etiologic diagnostic ( Echography, adenogram).~      Echography examination should be a guide to take in charge the adenopathy and to predict~     presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of~     this study is to codify the management of adenopathic patient with a diagnostic in 48 hours~     after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid~     wasting time in case of a serious pathology.~   "
31423|NCT02645812|"~     Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in~     routine as well as research oriented clinical practice.~      Various questionnaires measuring fatigue have been developed, but few have been validated in~     french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one~     study. BFI (Brief Fatigue Inventory) has been translated but never validated in french~     language.~      The main purpose of this study is to validate psychometrically the french version of BFI.~   "
31424|NCT02645799|"~     The main objective of this study is to assess the safety, efficacy and dose response of~     LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI)~     with a drug eluting stent in reducing restenosis as measured by Optical Coherence Tomography~     (OCT) at 9 months post procedure in patients with diabetes mellitus (DM).~      Administration of LABR-312 at the time of PCI will reduce restenosis compared with placebo~     as assessed by the OCT endpoint of % neointimal hyperplasia (%NIH) volume at 9 months in~     patients with DM.~   "
31425|NCT02645786|"~     The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH)~     over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered~     during suppression therapy.~   "
31426|NCT02645773|"~     To investigate intervention with early application of non-ablative laser to prevent scarring~     in the skin~   "
31427|NCT02645760|"~     The purpose of this study is to examines the effectiveness of Core stabilization exercise on~     pain intensity at rest, functional disability, lumbar movement and ability to perform~     repositioning tasks (joint position sense) in patients with subacute non-specific low back~     pain.~   "
31428|NCT02645747|"~     The objective of this retrospective chart review is to evaluate drug utilization, usage~     patterns and indication of effectiveness Eylea in the routine clinical (real-life)~     management of patients who suffer from ME(Macular Edema), secondary to CRVO(Central Retinal~     Vein Occlusion ), and who started treatment with Eylea for this indication.~   "
31429|NCT02645734|"~     In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema)~     to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at~     dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .~      The study drugs were administered as often as every 4 weeks for 3 months.monitoring of~     best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence~     tomography) was done from base line ,4 weeks, 8weeks after injection.~   "
31430|NCT02645721|"~     The purpose of this study is to determine whether extensive internet based cognitive~     behavior treatment program with guidance is a more effective method to treat individuals~     with alcohol use disorders than a briefer cognitive behavior treatment program without~     guidance.~   "
31431|NCT02645708|"~     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to~     eliminate stone completely, hastening fragments clearance just only rely on traditional~     expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive~     therapy and changing body position. Therefore, researchers purpose to evaluate the~     effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual~     fragments after RIRS by prospective study of clinical trial, which will improve stone-free~     rate of residual fragments and benefit more patients.~   "
31432|NCT02645695|"~     Effects of the high frequent chest wall oscillation technique applied on the patients who~     were intubated in intensive care unit were investigated.~      A total of 30 patients who were intubated and under the mechanical ventilator supplied, were~     included in the study. While the control group (n=15) received routine pulmonary~     rehabilitation technique, the study group (n=15) was administered high frequency chest wall~     oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary~     rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index~     and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal~     aspirate culture was studied at initial and 72nd. In addition, patient outcomes were~     evaluated at the end of the first week.~   "
31433|NCT02645682|"~     The purpose of this study is to investigate the effect of anti-infective central venous~     catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically~     ill patients in China, and the relationship between catheter-related bloodstream infection~     and catheter-related thrombosis.~   "
31434|NCT02645669|"~     Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial~     feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory~     cytokines and promotes the production of anti-inflammatory cytokines such as IL-10, which is~     pertinent in the context of pathogenic mechanisms in periodontitis.~   "
31437|NCT02645630|"~     Cervical spine manipulation has been found to be effective in patients with mechanical neck~     pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual~     intervention. In addition, some authors have proposed that spinal manipulation can alter~     proprioception of the cervical spine. The aim of this study will be to investigate the~     effects of cervical spine manipulation on pain, disability, widespread pressure pain~     sensitivity, and cervicokinethesia in patients with mechanical neck pain.~   "
31438|NCT02645617|"~     The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.~   "
31439|NCT02645604|"~     Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten~     by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat~     malaria. Although iAL has helped make the malaria problem less severe in the African country~     of Mali, researchers want to find out if malaria parasites are becoming resistant to this~     drug.~      Objective: To test for AL-resistant parasites in children with malaria in Mali.~      Eligibility:~      AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and~     have malaria.~      Blood collection substudy: healthy volunteers aged 18 65 years.~      Design:~      Volunteers for the substudy will have blood taken up to 6 times a year.~      Study participants will be screened with 1 finger-prick blood sample. Girls may have a~     pregnancy test.~      Baseline visit: Participants will have a physical exam. Their vital signs and temperature~     will be measured. They will answer questions about their symptoms. They will give a blood~     sample.~      Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk.~      Some participants will also stay at the clinic for 2 days. They will have a catheter placed~     in a vein. They will have blood taken frequently.~      Participants will have follow-up visits for about 1 month. They may have:~      Physical exam performed~      Vital signs and temperature measured~      Symptom questionnaire administered~      Finger-prick blood sample and/or a regular blood sample taken~      Pregnancy test given~      Antimalarial medications other than AL provided.~   "
31440|NCT02645591|"~     The goal of this clinical research study is to learn about the safety and the effectiveness~     of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help~     improve the return of erectile function and bladder control in patients after robotic~     assisted laparoscopic radical prostatectomy (RARP).~      dHACM is a section of tissue made from part of the placenta donated by a mother during a~     C-section. It looks like a small piece of tissue paper and is wrapped around the nerve~     bundles in the surgical area. The tissue may help the body's normal healing process.~   "
31441|NCT02645578|"~     This study is a prospective multicenter randomized controlled trial from Asian countries to~     compare the effect and safety of right median nerve stimulation versus traditional treatment~     for comatose patients at the early stage following traumatic brain injury.~   "
31442|NCT02645565|"~     This study will be conducted to find out whether low dose or high dose cyclophosphamide~     therapy is effective in the treatment of proliferative lupus nephritis.It will also compare~     the side effects and risks of infection in low dose and high dose cyclophosphamide group.~     Half of the participants will receive a low dose cyclophosphamide for 3 months and half will~     receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2~     mg/kg.~   "
31443|NCT02645552|"~     This study is a prospective single-centre randomized trial to compare the effect of~     tranexamic acid versus placebo in the pre-hospital management of patients with moderate and~     severe traumatic brain injury.~   "
31444|NCT02645526|"~     The aim of the present study is to assess the effectiveness and the safety of a woolen cap~     in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care~     (KMC).~   "
31445|NCT02645513|"~     The purpose of this study is to assess whether twice-daily text message reminders over a~     six-month period to health workers in Malawi about diagnosis and treatment of malaria,~     pneumonia, and diarrhea improve case management of these diseases.~   "
31446|NCT02645500|"~     In this study, the investigators would use the training workshops as a capacity build method~     to deliver the holistic health knowledge for the trainers and ambassadors implementing and~     assisting the community-based programs for the public. The investigators hypothesize that~     the training workshops and mobile health messages would promote the health awareness and the~     health of the participants. The investigators would expect the participants influence the~     health behavior and attitude of their family members.~   "
31447|NCT02645487|"~     SRS dose escalation for brain metastases in radiation-naïve patients will establish true~     tolerable doses, which may exceed the current standard doses. This may lead to an~     improvement in local control, patient survival, and/or quality-of life.~   "
31448|NCT02645474|"~     Two regional anesthesia techniques already in use in common clinical practice -paravertebral~     block and pectoral nerve block (PECS block) are compared in a randomized case-control study,~     in order to assess their efficacy on postoperative pain after breast surgery.~   "
31449|NCT02645461|"~     Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration~     and progressive paralysis. Other studies have revealed defects in skeletal muscle even in~     absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and~     supporting the so-called dying-back hypothesis. Outcome of this study will be to~     understand if the endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of~     AChRs currents in ALS muscle, and if it can modify ALS patients' clinical and~     electrophysiological parameters.~   "
31462|NCT02645292|"~     The worldwide epidemic of physical inactivity is rising significantly and the main cause is~     sedentary lifestyle. In this era of globalization and rapid advancement of technology,~     people are chasing after worldly matters, leading them to abandon the most important factor~     in their life and that's their body. Most people are leading a sedentary lifestyle as they~     indulge themselves in their never-ending work. There is a significant lack of awareness on~     the importance of physical activity and cardiorespiratory fitness to health as people are~     focusing more on factors such as smoking, cholesterol and hypertension. The purpose of this~     study is to evaluate the effectiveness of stair climbing (SC) and 1 mile walking (1MW) in~     relation to cardiorespiratory responses and fitness.~   "
31463|NCT02645279|"~     The purpose of this study is to demonstrate the effectiveness of oral glucose administration~     during MRI for imaging of newborns and compare with midazolam sedation.~   "
31450|NCT02645448|"~     The aim of this study was to investigate and correlate the glucose responses and VFC 24~     hours after resistance exercise (RE) sessions at different intensities in women with type 2~     diabetes (DM-2). Twelve women with DM-2 were invited to perform by one week in randomized~     order, two weeks interventions with experimental sessions: Session Control (CONT) without~     conducting RE, RE session (40% or 80% of one maximum repetition - 1RM) on day 2 and day 3~     was observed the effect of the length of RE session by 11h. After that, initiated the~     experimental sessions, where after each of the analysis of glucose 24h by continuous~     monitoring system of glucose was performed, considering breakfast, lunch, dinner and sleep,~     and analysis performed of the RR series by a period of 48h. During control sessions, the~     subjects were seated comfortably for 40min and RE sessions, 40%1RM and 80%1RM, were~     performed in medium circuit 3 sets with 16 and 8 replications and recovery range between 60~     exercises and 90seg , respectively, and between the circuits 120sec. It was observed that~     the concentration of glucose in the period of 24h after the session has been reduced to 40%~     1RM vs. CONT and 80%1RM. Hyperglycemia was prevalent in the period 34h of the sessions CONT~     and 80%1RM, respectively , being different from the session 40%1RM. In postprandial times,~     shorter hyperglycemia was found in the session to 40% 1RM vs. CONT and 80% 1RM after~     breakfast, lunch and dinner. At the time of sleep, less time in hyperglycemia was found~     between sessions of 40% 1RM vs. 80% 1RM. Significant correlations (p <0.01) were found~     between glucose 24h with cardiac autonomic RRi variables, HF, LF and reason LF:HF.~   "
31451|NCT02645435|"~     Background:~      Direct anterior approach to the hip (DAA) is being considered as one of the most promising~     minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to~     analyse influence of learning curve on clinical and radiographic outcome in direct anterior~     approach (DAA) for total hip replacement.~      Methods:~      The first 30 patients operated with DAA (group B) were compared to 39 patients operated by~     Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS),~     implant positioning, experienced pain and patient satisfaction were evaluated at a mean~     follow-up of 32 months.~   "
31452|NCT02645422|"~     The aim of the present study is to identify new obesity-related genetic defects and~     determine their association with clinical manifestations in families with childhood-onset~     severe obesity. The investigators hypothesize that by exploring children with severe~     early-onset obesity they can find new obesity-related genetic defects and by exploring~     obesity-associated clinical manifestations the investigators can elucidate the outcomes of~     severe childhood obesity.~   "
31453|NCT02645409|"~     Primary~      • To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy~     at the margins of resection, and in lymph node(s) or other metastases during radical~     nephrectomy.~   "
31454|NCT02645396|"~     The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV)~     infection in newborns born to seropositive women.~   "
31455|NCT02645383|"~     The aim of this study is to compare the severity of expressed pain scores in patients with~     PDR who underwent either PASCAL or conventional laser and to assess the association between~     patient characteristics and severity of pain.~   "
31456|NCT02645370|"~     The purpose is to evaluate the effectiveness and safety profile of Danzhen for the~     prophylaxis of migraine in a real-world setting.~   "
31457|NCT02645357|"~     Implementing an evidence-based computerized decision support system linked to electronic~     health records to improve care for cancer patients.~      The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel~     group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study~     Center(s) Single-center~      Objectives:~      The primary outcome of this trial is a process outcome. i.e. the rate at which the issues~     reported by the reminders are resolved (resolution rates).~   "
31458|NCT02645344|"~     The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation~     (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on~     reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of~     activities of daily living (ADL). Sixty subacute patients with left UN after~     right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS~     alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the~     contralesional hemisphere while vibration cueing was emitted using a wristwatch device on~     the hemiplegic arm, five days per week for two weeks. The first two groups received the same~     dosage of conventional rehabilitation on top of their experimental interventions. Blinded~     assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up~     upon completion of training.~   "
31459|NCT02645331|"~     The aim of this study was to determine the effects of an innovative child-friendly~     remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement~     therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an~     evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual~     Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3~     special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over~     15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand~     Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3~     for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.~   "
31460|NCT02645318|"~     Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via~     targeted DNA sequencing in surgical NSCLC patients.~   "
31461|NCT02645305|"~     Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases~     including chronic bronchitis, emphysema and chronic obstructive airways disease. People with~     COPD have difficulties breathing, primarily due to the narrowing of their airways, this is~     called airflow obstruction.~      Some preclinical evaluations showed that COPD is closely related to chronic inflammation;~     therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of~     non-expanded culture - that usually names as a stromal vascular fraction (SVF) in~     combination with activated platelet rich plasma (PRP) to treat this disease. Both SVF and~     PRP are autologous sources that obtained from adipose tissue and peripheral blood,~     respectively. This mixture is intravenously transfused into the patients.~   "
31476|NCT02645110|"~     The purpose of this study is to evaluate the effectiveness of whole-natural hand-wash~     formulations in bacterial removal and to estimate the relative mildness of the formulations.~   "
31464|NCT02645266|"~     Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even~     though significant research has been done to clarify the pathogenesis of DME, a clear causal~     pathway of the complication is of yet undetermined. However, there is some consensus among~     researchers that a cascade of inflammatory markers plays an important role in the disease~     process. Here we hope to better delineate the role these inflammatory markers play by~     investigating whether basal levels predict response or lack thereof to Aflibercept.~   "
31465|NCT02645253|"~     This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the~     safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics~     [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as~     single and multiple ascending doses once daily by inhalation to healthy male Japanese~     subjects, compared with placebo (non-active drug)~   "
31466|NCT02645240|"~     The study aims to identify several factors that can accurately predict the incident of~     intestinal infraction in patients with mesenteric vascular occlusion or ischemia.~   "
31467|NCT02645227|"~     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin~     (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony~     defects in chronic periodontitis patients~   "
31468|NCT02645214|"~     This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover~     design to determine if antiseptic-impregnated surgical scrubs decrease the burden of~     healthcare providers (HCP) clothing contamination compared to standard, control surgical~     scrubs following a 12-hour ICU shift.~   "
31469|NCT02645201|"~     The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are~     marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter~     pylori eradication rate compared to the single strain ATC 55730, due to additional~     anti-inflammatory properties of the second strain.~      Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to~     an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication~     rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori~     bacteria.~   "
31470|NCT02645188|"~     Do specific verbal and tactile cues and instructions help people who perform bridging~     exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus~     muscle?~   "
31471|NCT02645175|"~     A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety~     profile and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic~     breast cancer patients receiving chemotherapy.~   "
31472|NCT02645162|"~     Worldwide about 88 million children drop out of primary school annually. One of the~     contributory factors is a lack of school readiness among young children, their families and~     their teachers. To better prepare young children for school, investment in early childhood~     interventions is necessary. Young children require good health, adequate nutrition and~     social-emotional, cognitive and communication skills to succeed in school, which requires~     both support in the family environment and a stable transition to the classroom environment.~     Preschool programmes are designed to prepare children for formal learning. However, in many~     low- and middle-income countries there is poor access to quality preschool programmes.~     Further, the scale-up of early childhood interventions is challenged by a number of barriers~     such as poor supply (e.g. policy provisions, financing, distance, early child development~     workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization,~     agency, community of purpose, opportunities to participate) and weak quality of services~     (e.g. training, supervision and monitoring systems).~      In partnership with the National Commission for Human Development, we propose to implement~     an early childhood care and education programme in rural Sindh that is championed by~     Community Youth Leaders. The Community Youth Leaders will run community preschools for~     children aged 3-6 years, and will also coordinate local community engagement and local~     stakeholder strategies across sectors to leverage demand-side actions to promote ownership~     and scale-up of early childhood interventions. The LEAPS Programme (Youth Leaders for Early~     Childhood Assuring Children are Prepared for School) will be evaluated by a cluster~     randomized controlled efficacy trial. The primary outcome will be children's school~     readiness, indexed by both early academic and social emotional competencies assessed~     following 6-9 months of intervention exposure. The compliance, fidelity and quality of the~     implementation process will also be assessed in order to understand how these features~     moderate outcomes and whether community-engagement strategies facilitate demand-side actions~     for scale-up. The expected outcomes for this trial will include a model for quality~     preprimary education that addresses a current supply-side gap, and will facilitate learning~     for demand-side actions to support scale-up across a broad range of early childhood~     interventions.~   "
31473|NCT02645149|"~     This is a patient oriented translational research project aiming to improve clinical~     outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV~     metastatic melanoma who have progressed on, or are unable to receive standard therapy (in~     general, immunotherapy). Consecutive patients seen at three major clinics and fitting the~     broad eligibility criteria will be invited to participate.~      The approach is designed to test the impact of different targeted drugs on different~     mutations in a single type of cancer. In this project, patients will have tumour tissue~     genetically profiled to determine which mutation(s) are present, and will then be assigned~     to receive a matched drug expected to target the mutation(s) in the tumour. Where multiple~     targets are identified in one patient, or where multiple potential therapies would be~     appropriate for a single tumour mutation, the treating clinician may determine the~     appropriate therapeutic approach after consultation with the study team, using the latest~     version of library of matched therapies.~   "
31474|NCT02645136|"~     The purpose of this study is to compare the efficacy between a Pilates exercise program and~     a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation~     (AES) in muscular pressure strength of the pelvic floor as conservative treatment of urinary~     incontinence after prostatectomy.~   "
31475|NCT02645123|"~     Introduction: patients with chronic back pain as a result of degenerated disc disease,~     besides pain also present with impaired gait. The purpose of this study is to evaluate both~     the clinical data using clinical rating scales, such as Oswestry Disability Index Greek~     version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the~     Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic~     characteristics during gait analysis in patients with chronic low back pain as a result of~     the degenerated disc disease (Disc Degenerative Disease), before and after application of~     manual therapy techniques.~      Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain~     were randomly divided into 3 groups of 25 each. Each group received five sessions with the~     first group receiving manual therapy treatment (spinal mobilisation), the second a sham~     treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To~     evaluate the effectiveness of each treatment, the visual analog pain scale, two~     questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording~     and analysis of gait (kinetic and kinematic data) were utilized.~   "
31478|NCT02645084|"~     In this trial the investigators will evaluate the effectiveness of the implementation of a~     digital familial risk questionnaire in the detection of CRC patients with hereditary or~     familial CRC. This will be done using a stepped wedge design with 5 participating hospitals~     for a duration of 1.5 years. A comparison is made between an intervention phase (offering~     the online risk assessment questionnaire) and a control phase (hospital-based standard~     practice for the detection of CRC patients with hereditary or familial CRC, informed by the~     referral criteria that are being used in the intervention group). All patients with a~     diagnosis of CRC who have a first appointment at the CRC outpatient clinic will be included.~     The primary outcome is the percentage of all included patients who receive a recommendation~     for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a~     clinical geneticist. Data from clinical geneticists is being used to answer this question.~   "
31479|NCT02645071|"~     Lack of physical activity was found to be a local and worldwide issue. Most Hong Kong people~     are having sedentary lifestyle. Researchers show that the increase of physical activity~     reduces the risk of chronic diseases, and improve cardio-pulmonary functions; whereas~     sedentary behaviors increase the risks.~      For many people, the targets of the WHO physical activity guidelines are too high to be~     achieved. Some people are not even willing to try, despite the evidence for the protective~     benefits to their long term health. In response, a recent focus has been placed upon~     reduction of sedentary behavior. Sedentary behavior is defined as 'those activities that do~     not increase energy expenditure substantially above the resting level, such as sitting,~     lying down, or viewing TV, or simply as too much sitting. The primary determinants of~     sedentary behavior are behavioral and context-based, such as TV and screen-focused behaviors~     in home and work environments, sitting at work, and sitting during transport. The public~     health leaders have called for reducing the time spent in sedentary behaviors as a possible~     public health priority. This study will focus on reduction of sedentary behavior and~     increasing physical activity in daily life. We hypothesize that the training programs would~     promote the health awareness of the participants.~   "
31480|NCT02645058|"~     To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL~     (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20~     mm size.~   "
31481|NCT02645045|"~     In this study, the investigators aim to determine the effects of age, sex, history of ocular~     surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid~     layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with~     dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All~     participant will underwent LLT measurement with a LipiView interferometer, tear meniscus~     height measurement using optical coherence tomography, tear film break-up time (TBUT)~     determination, corneal and conjunctival staining, Schirmer's test, examination of the lid~     margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI)~     questionnaire.~   "
31482|NCT02645032|"~     This is a Phase I, Randomized, observer-blinded, age de-escalating study.~      The study objectives are~      to evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4~     weeks.~      to assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0~     and 4 weeks.~      to compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.~   "
31483|NCT02645019|"~     A prospective study designed to access changes in the intracuff pressure of a laryngeal mask~     airway (LMA) or cuffed endotracheal tube (cETT) during placement of an~     esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.~   "
31484|NCT02645006|"~     The purpose of this study is to determine whether a primary prevention workshop is effective~     decreasing at least 13% the annual incidence of falls in elderly compared to the habitual~     counseling.~      Before the first fall incident, the elderly aged 65 or more, living in community, are~     invited to attend a workshop on fall preventing activities and factor risk detection. This~     activity consists on four sessions (one session per week during three weeks and the fourth~     session one year later) in which the elderly are expected to detect their own fall risk~     factors, encouraged to introduce healthy habits and to increase physical activity in order~     to improve strength and balance specifically.~      This workshop has been prepared by family physicians following the latest scientific~     recommendations, it will be lead by them on the first edition, but it has not been written~     in formal language in order to be used by volunteers concerned about aging topics,~     independent from the Health Service.~   "
31485|NCT02644993|"~     The study aim of this study is to evaluate the effect of proton therapy on quality of life~     and long-term normal tissue toxicities of the pediatric cancer patients. Based on these~     results, the predictive model of long-term normal tissue toxicities, survival, and quality~     of life could be recognized. Risk-adapted treatment strategy based on the predictive model~     in pediatric cancer patients could be established.~   "
31486|NCT02644980|"~     For patients requiring the heart valve replacement surgery, heart function is injured in~     different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular~     system has important clinical meanings. Etomidate has slight effect on the cardiovascular~     system, often used in the induction of anesthesia, however target controlled infusion~     etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe~     the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.~   "
31487|NCT02644967|"~     The goal of this clinical research study is to find the highest tolerated dose of the study~     drug IMO-2125 that can be given in combination with ipilimumab or in combination with~     pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the~     study drug combination can help to control the disease. The safety of the drug combination~     will also be studied.~   "
31488|NCT02644954|"~     Psoriasis vulgaris is a common, chronic, relapsing skin disease characterized by predominant~     involvement of skin, nails and joints. Recent advances in its patho-physiology have shifted~     the notion of psoriasis from that of a 'disease of the skin' to a 'T-cell mediated systemic~     disease'. Better understanding of its pathogenesis and co-morbidities along with the~     development of novel therapeutics like biological response modifiers has changed the way~     dermatologists approach the management of psoriasis. Based on the extent of involvement and~     effect on the quality of life, psoriasis may be mild to moderate in severity. This in turn~     forms the basis of treatment in majority of the patients. Topical therapies like coal tar,~     calcipotriol and corticosteroids are sufficient for mild and localized psoriasis. In more~     widespread or severe forms that are associated with significant decrease in quality of life~     of patient, phototherapy and systemic therapies are indicated either alone or in combination~     with each other. Although the introduction of biological therapies has revolutionized the~     treatment of psoriasis in recent years, such newer therapeutic options continue to elude the~     vast majority of patients in the developing and under developed world where the traditional~     agents like methotrexate, cyclosporine, acitretin and phototherapy still form the backbone~     of treatment.~      The association of psoriasis with metabolic syndrome is now well documented. Metabolic~     syndrome is a cluster of risk factors including central obesity, atherogenic dyslipidemia,~     hypertension and glucose intolerance and is a strong predictor of cardiovascular diseases,~     diabetes and stroke. Metformin, an oral hypoglycemic agent of biguanide class is known for~     its multitude of action on various facets of metabolic syndrome. Recently it has also been~     found to inhibit keratinocyte proliferation in cell culture model of psoriasis.~      The present study is designed as a randomized controlled double blind pilot study in which~     40 patients with chronic plaque psoriasis of moderate severity (PASI ≥ 6 or DLQI ≥ 6) and~     metabolic syndrome (By modified ATP III criteria)4 or impaired glucose tolerance (defined as~     two-hour glucose levels of 140 to 199 mg per dL on the 75-g oral glucose tolerance test)~     will be recruited and randomized into two arms, A and B of 20 each, by using random number~     tables. Patients in arm A will be treated with topical anti-psoriatic treatment (including~     coal tar and vitamin D3 analogues only) and oral metformin 1g/day 850mg twice daily and~     patients in arm B will be treated with topical anti-psoriatic treatment and oral placebo~     tablets. Post randomization patients will be followed up at regular intervals for 24 weeks.~     During each visit, patients in both arms will be assessed for the severity of psoriasis by~     psoriasis activity severity index (PASI) and body mass index (BMI). Fasting blood glucose~     and insulin level, glycosylated haemoglobin (HbA1c) and parameters of metabolic syndrome~     (including waist circumference, fasting lipid profile and blood pressure) will be assessed~     at baseline and again at week 16 and 24. The primary aim of this study is to assess the~     efficacy and safety of oral metformin as an add on therapy for the treatment of chronic~     plaque psoriasis of moderate severity. The secondary aim is to assess the effect of~     metformin on parameters of the metabolic syndrome.~   "
31489|NCT02644941|"~     The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE~     grafts when used for hemodialysis access.~   "
31490|NCT02644928|"~     This study is designed as a prospective, single-center, longitudinal and analytical study on~     the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).~   "
31613|NCT02643303|"~     This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and~     the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment~     (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable,~     biopsy-accessible cancers.~   "
31491|NCT02644915|"~     Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after~     kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone~     is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments~     have revealed its beneficial effects against I/R injury, our goal is therefore to~     investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the~     occurrence of DGF after kidney transplantation.~   "
31492|NCT02644902|"~     The Thinking Healthy Program is evidence based psychological intervention, delivered by~     non-specialists, with proven impact on maternal depression. A major challenge in the~     scale-up of this intervention, especially where health systems are weak, is providing~     quality training and supervision at scale. Women living in post-conflict areas are at a~     higher risk of depression than the general population.The key innovation proposed is the~     development and evaluation of a technology-assisted cascade training and supervision system~     to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.~   "
31493|NCT02644889|"~     This study has been designed in order to detect EGFR mutation abundance of tissue and~     concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with~     Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate~     the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and~     prognosis.~   "
31494|NCT02644876|"~     Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity,~     mortality, and prolonged hospital stay.The incidence of PPCs may be as high as 41% to 75% in~     high-risk patients. Bronchodilator is frequently used in high-risk patients to prevent PPCs.~     Penehyclidine is a new anticholinergic agent which selectively block M1 and M3, but not M2~     receptors. A pilot study of the investigators showed that prophylactic penehyclidine~     inhalation reduced the incidence of bronchospasm and the use of aminophylline in elderly~     patients after long-duration surgery. The purpose of this study is to investigate whether~     prophylactically penehyclidine inhalation could decrease the incidence of PPCs in high-risk~     patients after major intrathoracic and upper intraabdominal surgery.~   "
31495|NCT02644863|"~     This study evaluates the safety and efficacy of D-CIK immune cells combined with~     chemotherapy after resection of esophageal cancer~   "
31496|NCT02644850|"~     To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT)~     single photon emission computed tomography (SPECT) with planar equilibrium radionuclide~     angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.~   "
31497|NCT02644837|"~     This study will look at key performance indicators of 2 supraglottic airway devices in~     anaesthetised adults in a crossover manner.~   "
31498|NCT02644824|"~     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low~     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased~     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD~     undergoing surgery with CPB can experience well-characterized post-operative cardiac~     dysfunction. When severe, patients can develop clinically important low cardiac output~     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise~     is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine,~     which affect the strength of the heart's muscular contractions. These are used to maintain~     adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental~     to myocardial function and may increase risk for post-operative arrhythmia and impair~     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).~     In combination with the increased VO2 associated with CPB-induced systemic inflammatory~     response patients can develop a critical mismatch between oxygen supply and demand,~     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic~     stability without increased VO2 are beneficial. This study will test whether BiVp, a~     specialized yet simple pacing technique, can improve post-operative CI and recovery in~     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study~     hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours~     in infants with EMD following CHD surgery compared to standard care alone.~   "
31499|NCT02644811|"~     The purpose of this trial is to study and compare two different anchorage techniques.~     Adolescent patients in need for orthodontic treatment are randomized into Group A and B.~     Both groups are treated with extractions of the maxillary first premolars and fixed~     appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.~      The hypotheses are:~        -  that miniscrews have a better anchorage capacity than molarblock,~        -  that placement of miniscrews does not cause more pain or discomfort than tooth~          extractions,~        -  that molarblock provides increase of anchorage~        -  that miniscrews are more cost-efficient than conventional anchorage techniques,~   "
31500|NCT02644798|"~     Few patients who have major risk factors develop Acute Respiratory Distress Syndrome (ARDS).~     The heritable determinants might be the reason. The multicenter study is to investigate the~     association between ARDS and polymorphism in ARDS gene r.~   "
31501|NCT02644785|"~     The investigators aim to assess tryptase test efficacy for measuring the allergic response~     to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish~     a differential diagnosis on the basis of potential allergens or clinical causes.~   "
31502|NCT02644772|"~     The purpose of this study is to determine whether the investigators can predict which~     patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in~     lung capacity during the initial exacerbation.~   "
31503|NCT02644759|"~     Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the~     progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin~     production and secretion. Hence, an effective treatment for T1DM should focus on controlling~     anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations,~     with minimal risk to the patient.~      This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of~     T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine~     the combined effects of autologous stem cell transplantation and immunomodulation, on~     regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells,~     respectively.~   "
44881|NCT02469519|"~     This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal~     steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor~     premature rupture of the membranes.~   "
31504|NCT02644746|"~     Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the~     primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective~     for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture~     efficacy is critical for making informed decisions about its appropriate role for patients.~     A total of 80 participants meet prior inclusion criteria will be recruited. The participants~     will be allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group~     randomly. Twenty-four treatments will be provided over 8 weeks. The primary change of~     Modified Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the~     change of Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the~     change of Swiss Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture~     might help participants with DLSS. All outcomes will be assessed at baseline, and/or after~     4, 8, 20 and 32 weeks. Statistical analysis will include independent sample t-test,~     Chi-squared test and non-parametric test. The investigators hope the result of this trial~     will clarify the value of acupuncture for DLSS and help clinicians make proper decisions.~   "
31505|NCT02644733|"~     Measuring intraabdominal pressure in the semi-recumbent position and supine position.~   "
31506|NCT02644720|"~     Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they~     can bring about halos and glare, which are caused by design deficiencies of the IOLs.~     Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may~     increase the difficulty of neural compensation reconstruction in patients with multifocal~     intraocular lens implantation. Patients enrolled into the study will be followed for 1 year~     and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months~     postoperatively.In this trial, we aimed to specify the time of neural compensation~     reconstruction in patients and to explore the changes of visual function in senile patients~     with monofocal or multifocal intraocular lens implantation.~   "
31507|NCT02644707|"~     To investigate whether the supplementation of organic selenium at the adult dose (200 mcg~     per day in the form of L-selenomethionine) has a favorable impact on thyroid function,~     including the titer of anti-thyroid antibodies [Anti-thyroid peroxidase (anti-TPO) and~     Anti-thyroglobulin (anti-Tg) antibodies], in children and adolescents with autoimmune~     thyroiditis (AT).~   "
31508|NCT02644694|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone~     phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in~     patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling~   "
31509|NCT02644681|"~     The primary objective of this study is to evaluate if the motor-evoked potentials/motor~     action potential amplitude ratio and motor action potential amplitude measurement are useful~     in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.~      The secondary objective is to evaluate the presence of a correlation between~     neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and~     physiologic changes) in order to find which factor is the most important in determining~     spinal cord ischemia.~      This study is an observational, single-center, prospective study on patients with~     thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative~     motor-evoked potentials and somatosensory evoked potentials monitoring.~   "
31510|NCT02644668|"~     The primary objective of this study is to demonstrate a pharmacodynamic effect of CK-2127107~     on measures of skeletal muscle function or fatigability in patients with Spinal Muscular~     Atrophy Types II-IV.~   "
31511|NCT02644655|"~     Objectives:~      The purpose of this study is to evaluate the safety and prognosis of New Cluster of~     Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of~     recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.~      Methods:~      This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled.~     Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4~     days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According~     to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks~     long. Follow-up survey after the clinical study: within 1 months, once a week; then once a~     month for 1 years; and then once a year, a total of 15 years.~   "
31512|NCT02644642|"~     Lung isolation technique is useful for lung or heart surgeries for better visualization.~     Double lumen endobronchial tube and bronchial blocker are available for lung isolation.~     Adding disconnection technique before lung isolation is helpful to accelerate the lung~     deflation. However, the utility of disconnection technique has never been evaluated in~     comparison of double lumen tube and bronchial blocker. Therefore, the utility of~     disconnection technique in two different lung isolation technique, double lumen tube and~     bronchial blocker will be evaluated~   "
31513|NCT02644629|"~     The current study wishes to contribute to the applicability of the use of ketamine in a~     clinical setting by focusing on the efficacy of intra-nasal administration compared with the~     IV route.~   "
31514|NCT02644616|"~     The investigators research the early improvement of fluid retention and mid-term prognosis~     through the administration of tolvaptan for the patient with tricuspid regurgitation and~     right heart failure after left heart valves replacement.~   "
31515|NCT02644603|"~     The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol~     versus conventional treatment on patients who underwent liver resection for hepatocellular~     carcinoma(HCC).~   "
31516|NCT02644590|"~     Nocturnal hypertension is recognized via ambulatory blood pressure monitoring in adolescents~     with type 1 diabetes mellitus.~      Melatonin, (as previously seen in earlier studies in adults), may alter these changes, which~     may be a benefit especially for patients with diabetes mellitus who are at risk for~     cardiovascular changes.~      The purpose of this study is to estimate the use of melatonin as treatment for nocturnal~     hypertension in young adults with type 1 diabetes melitus.~   "
31517|NCT02644577|"~     The purpose of this study is to test the efficacy of metformin for treatment~     antipsychotic-induced metabolic syndrome in bipolar disorder patients.~   "
31665|NCT02642627|"~     This is an open-label, multicenter, prospective pilot study assessing the efficacy and~     safety of Bellafill for correction of distensible atrophic acne scars in the full facial~     area. All enrolled subjects will receive initial treatment with Bellafill, as well as~     touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated~     at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.~   "
31518|NCT02644564|"~     The purpose of the study is to determine whether the introduction of early ultrasonography~     screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients~     aged forty years or more. We also want to study whether certain physical tests will be able~     to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the~     acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over~     a year, as well as to compare the results to studies on the prevalence of rotator cuff~     full-thickness tears.~   "
31519|NCT02644551|"~     This will be an interventional safety and efficacy study of CELENT07 when used as a topical~     treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older.~     This is randomized, double-blind, parallel design, placebo and active controlled study in~     patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO)~     (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or~     PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure~     and clinical efficacy and safety and tolerability.~   "
31520|NCT02644538|"~     This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance~     at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus~     treatment and reached HBV DNA<1000 copies/ml and HBsAg<3000 IU/ml, were randomly assigned~     into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add~     on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24~     weeks.~   "
31521|NCT02644525|"~     Background:~      Many people who live in west or central Africa are at risk for infection from a very small~     worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called~     microfilariae live in the blood. The infection most commonly causes skin itching, mild~     temporary limb swelling, and sometimes a adult worm can be seen in the white of the eye of~     an infected individual. Very rarely, people with this infection can develop problems with~     the kidneys and heart as a result of the worm s effect on the immune system. Because the~     vast majority of people with the infection have minimal symptoms, people in Cameroon usually~     do not get treated. But infection with Loa loa can cause serious problems in people who are~     being treated for infections with other parasites (namely, river blindness and lymphatic~     filariasis). Researchers want to find out of a drug called imatinib can treat Loa loa~     infection so that patients with this infection can safely receive other drugs to cure river~     blindness and lymphatic filariasis. Researchers believe imatinib can be a safe drug to use~     on Loa loa, because in the lab this drug kills the worms slowly, whereas other drugs which~     can cause treatment reactions usually kill the worms very quickly.~      Objective:~      To test if imatinib can treat Loa loa infection by killing the worms slowly.~      Eligibility:~      People ages 18 65 with non-severe Loa loa infection who are otherwise healthy~      Design:~      Participants will be screened with a physical exam and blood and urine tests.~      Participants will have a baseline visit. This will include a physical exam and blood and~     urine tests. It may include a stool sample. Participants will be randomly assigned to get 1~     dose of either imatinib or a placebo~      Participants will return to the clinic every day for 1 week, then once a week for 3 weeks.~     Visits will include a physical exam and blood tests. They will have urine tests in the first~     week.~      Participants will have follow-up visits 3, 6, and 12 months after taking the imatinib or~     placebo. These include a physical exam and blood tests. They may include urine and stool~     samples.~      If participants develop side effects, they will be treated for them.~   "
31522|NCT02644499|"~     This study will be conducted to find out how well a patient of rheumatoid arthritis (RA)~     will respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory~     arthritis, which leads to joint damage & disability if not treated properly. A DMARD is used~     to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or~     inflammation by painkillers. The study will be conducted at the Department of Clinical~     Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research).~     Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy~     (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood~     investigations will be carried out to monitor treatment response and side effects.~   "
31523|NCT02644486|"~     To observe the decreased levels of low-density lipoprotein from baseline in patients with~     obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.~   "
31524|NCT02644473|"~     To evaluate whether there is a difference in symptomatic thromboembolism events in the~     subset of patients with a history of, or risk factors for thromboembolic disease for~     topically applied tranexamic acid in total joint arthroplasty.~   "
31525|NCT02644460|"~     This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin~     dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed~     diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive~     malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum~     B).~   "
31526|NCT02644447|"~     Cellular therapies are rapidly progressing fields and have shown immense promise in the~     treatment of damaged ovarian function. The purpose of this study is to determine safety and~     efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold~     in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of~     HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.~   "
31527|NCT02644434|"~     The purpose of the present study is to investigate if intentional strategy (a more~     aggressive side branch protection strategy: elective two-stent or jailed balloon technique)~     is associated with significant reduction of side branch occlusion rate compared to~     conventional strategy (provisional two-stent strategy or jailed wire technique) in patients~     at high risk of side branch occlusion (V-RESOLVE score≥12).~   "
31528|NCT02644421|"~     Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single~     intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will~     be administered as a positive control. The study will take place during a single inpatient~     visit involving three separate treatment periods, each with a washout of (>16-hours. Study~     drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.~   "
31529|NCT02644408|"~     Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can~     improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance~     put, chemotherapy, improve the quality of life, is widely used in tumor radiation and~     chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal~     bleeding, arrhythmia and other serious complications, there is no unified standard.~      The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical~     chemoradiation curative effect and side effects, for rational use in the process of~     radiation and chemotherapy megestrol provide guidelines. A total of 210 patients will be~     accrued from China within 2 years.The primary endpoint is overall survival and the secondary~     endpoints include gastrointestinal reaction body weight change, performance status,~     leucopenia and deep venous thrombosis.~   "
31530|NCT02644395|"~     Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs~     to prevent rejection after kidney transplantation. However, the efficacy of preventing~     rejection comes at the cost of important side-effects. Among the most common side-effects is~     hypertension. Hypertension after kidney transplantation is clinically relevant, because it~     increases the risk of cardiovascular disease and is associated with increased graft loss and~     recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood~     and, therefore, the treatment is currently empiric. These and other investigators recently~     showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the~     kidney, namely the thiazide-sensitive sodium chloride cotransporter.~      Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to~     calcium channel blockers (CCBs) (currently usually the treatment of choice) for the~     treatment of CNI-induced hypertension.~      Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients~     with CNI-induced hypertension.~      Study design: Single-center, randomized cross-over trial.~      Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30~     ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not~     have proteinuria (< 1 g/day).~      Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if~     needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to~     10 mg once daily).~      Main study parameters/endpoints: 24-hour blood pressure recording.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both drugs have long been registered for the treatment of hypertension. The~     side-effect profile of both drugs is considered to be equal. The burden of the study for the~     patients are blood pressure measurements using 30-minute automated blood pressure~     measurement and 24-hour ambulatory blood pressure measurement.~   "
31531|NCT02644382|"~     The overall goal of this study is to qualitatively assess the surgical decision-making~     process from both the patient and physician perspective~        1. Conduct short in-person interviews with young women prior to surgery~        2. Conduct focus groups with breast cancer survivors about their surgical decision and~          experience~        3. Interview surgical oncologists, plastic surgeons, medical and radiation oncologists~          about their experiences and how they communicate with breast cancer patients about~          local therapy decisions~   "
31532|NCT02644369|"~     This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers~     in patients with solid tumors during treatment with pembrolizumab and in relation to~     response to treatment.~      Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed~     cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer~     cells.~   "
31533|NCT02644356|"~     Palliative care represents one of the most rapidly expanding sectors of health care. Its~     rapid growth has been accompanied by widespread needs for training of multidisciplinary~     personnel to work with the unique set of health issues specific to its population of~     patients - not only those at end-of-life, but also patients with long-term, incurable,~     chronic and degenerative illnesses. This project will develop the first online continuing~     education program for palliative care personnel in the evidence-based application of~     complementary therapies, to enhance patient care and quality of life in the palliative care~     setting.~   "
31534|NCT02644330|"~     The purpose of this study is to evaluate the efficacy and safety of minimally invasive~     transthoracic device closure of ventricular septal defect. This is a multi-center randomized~     controlled trial. Because of the characteristics of this surgical clinical trials, surgeons,~     ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care~     unit nurses are all need to be informed. Therefore the results of this trial need to be~     system evaluated through objective methods to reduce bias.~   "
31535|NCT02644317|"~     Flatfoot, one of the most common foot problems experienced by preschool-aged children,~     characterized by the collapse of the foot's medial longitudinal arch. Children with motor~     developmental delay often have flatfoot, according to clinical observation, and research~     indicates that preschool age is the main stage of the medial longitudinal arch development~     period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance,~     likely to cause gait problems while growing up. The lack of a stable foot structure to~     support and maintain posture may lead to delayed motor development. Early training~     intervention and help to balance stability is the main rehabilitation goal for motor~     developmental delayed children. With understanding of the foot development of motor~     development delayed children, proper intervention can be provided to improve the movement~     and stability of the lower limbs. The possible deformation of the foot structure and~     resultant pain in the future can also be prevented.~   "
31536|NCT02644304|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged~     women and affects approximately 5-12 % of the female population.~      In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected~     individuals must have two out of the following three criteria:~        1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).~        2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank~          virilization, while chemical indicators include raised concentrations of total~          testosterone and androstenedione , and elevated free androgen index.~        3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in~          either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3~          and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic~          criteria, the majority of women with PCOS can be diagnosed without the need of~          laboratory examinations.~      Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation.~     It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the~     latter being the more potent of the two. It is a non-steroidal compound closely resembling~     estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby~     signaling a lack of circulating estrogens and inducing a change in the pulsatile release of~     gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone~     from the anterior pituitary and is often enough to set the cycle of events leading to~     ovulation into motion.~      Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective~     prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg,~     which could be increased, if needed, to twice a week. This medicine has slight dopamine~     agonistic side effects, headache being the most common one. Treatment in the very beginning~     should start with a partial dose (half a pill) at bedtime with a small amount of food. Low~     incidence of side effects and its weekly dose has made Cabergoline a choice drug for~     treatment of related diseases.~   "
31537|NCT02644291|"~     This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers~     that include medulloblastoma and high grade glioma, that are no longing responding to~     standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange~     flavored tablet. It is already approved to treat parasitic infections. The purpose of this~     study is to determine the safety and side effects for increasing doses of mebendazole,~     followed by the treatment of an additional 12 patients at the best tolerated dose.~   "
31538|NCT02644278|"~     The purpose of this study is to evaluate the safety and tolerability of VX-984 administered~     alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the~     maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination~     with PLD in subjects with advanced solid tumors~   "
31666|NCT02642614|"~     The main objective of the current trial is to investigate safety, tolerability,~     pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for~     4 weeks in patients with COPD.~   "
31539|NCT02644265|"~     Detecting preserved consciousness in brain-injured patients by traditional clinical means~     requires presence of motor function. Otherwise, patients may be erroneously classified as~     being in a vegetative state. In order to circumvent the need for motor function, paradigms~     using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have~     been developed. According to a recent meta-analysis, 15% of patients with a clinical~     diagnosis of vegetative state can follow commands by performing mental imaginary tasks,~     strongly suggesting they are indeed conscious. This is of utmost importance for prognosis,~     treatment, and resource allocation. However, consciousness paradigms are usually employed in~     rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early~     stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study~     using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into~     neurocritical care. The investigators aim to assess patients with acute brain injury for~     preserved consciousness by serial multimodal evaluations using active, passive and resting~     state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for~     genomic and metabolomic research will be established. This approach will add essential~     clinical information, including detection of preserved consciousness in patients previously~     thought of as unconscious. Due to its complexity, this project is divided into nine work~     packages. Eventually, the investigators will have established a clinical service for the~     systematic assessment of covert consciousness, as well as an interdisciplinary research~     group dedicated to the neuronal mechanisms by which consciousness recovers after acute brain~     injury.~   "
31540|NCT02644252|"~     There is a need for improving the effect of first-line chemotherapy for lung cancer~     patients, preferably by using an approach with none or very few side effects.~      In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional~     supplement on top of standard chemotherapy for patients with advanced non-small cell lung~     cancer.~   "
31541|NCT02644239|"~     The ketogenic diet is a non-pharmacological treatment prescribed especially for children and~     indicated in most specialized centers for patients with refractory epilepsy. The composition~     of the ketogenic diet is based on high-fat, low-carbohydrate, moderate protein content, and~     the production of ketone bodies is the probable mechanism involved in the control of~     seizures. The relationship between the treatment of the ketogenic diet and changes in~     oxidative characteristics, physical and lipid are not well established. Some studies show a~     significant increase in total cholesterol and triglycerides in children being treated with~     ketogenic diet, but other studies have shown that changes in lipid profile in the long term~     do not appear to be significant, beyond the influence of these changes on coronary heart~     disease are unknown. The studies performed in the last two decades have shown that besides~     the changes in the lipid profile, oxidative modification of lipoproteins are essential for~     the initiation and progression of atherosclerosis and physical properties of lipoproteins~     also appear to be involved in this process, suggesting that the particle size of~     lipoproteins, through the analysis of subfractions can provide more details of the~     cardiovascular risk. Thus, this projetct aims to compare the effects of the classical~     ketogenic diet with the ketogenic diet modified with lower content of saturated fatty acids~     and a higher content of monounsaturated and polyunsaturated, the oxidative changes of LDL,~     lipidomic profile, the concentration of antioxidants in production inflammatory cytokines~     and the subfractions of LDL and HDL in children and adolescents with refractory epilepsy,~     the clinical effect on controlling epilepsy.~   "
31542|NCT02644226|"~     Desflurane is known to be the most pungent of the currently used volatile anesthetics. The~     investigators tried to find out if desflurane increases the incidence of perioperative upper~     airway complications in infants and children undergoing general anesthesia using~     supraglottic airways compared to sevoflurane.~   "
31543|NCT02644213|"~     The aim of the research is to evaluate the influence of physical and cognitive load as~     pre-mission activity on the soldier`s physical and cognitive performance, in compare to~     physical load alone.~      In order to do so, 12 healthy subjects will perform stimulated road march using a virtual~     reality environment combined with cognitive load and without, and their physical and~     cognitive performance will be evaluated by tests before and after.~   "
31544|NCT02644200|"~     Oral rehydration therapy is the only treatment recommended by the World Health Organization~     in acute diarrhea in children. The aim of this study was to compare the efficacy and safety~     of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in~     children with acute gastroenteritis.~      This is a single-blind, prospective, randomized and parallel study performed in two~     Pediatric Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute~     gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral~     rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the~     number of bowel movements after 48 and 72 hours after initiating treatments. Secondary~     outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other~     clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two~     treatments were also recorded.~   "
31545|NCT02644187|"~     This pilot study will try to minimize the pain during exposure to a new red light source~     (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without~     compromising its effect on AKs.~      The study design will have an open and prospective, two-armed, split-face design.~     Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks,~     torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose~     is to investigate if a modified irradiation protocol can lower the pain while having the~     same effect on AK clearance rates as compared to the standard PDT irradiation protocol.~      Before any study-related procedures are performed, the participants will be thoroughly~     informed about the study and will be given the opportunity to ask questions. The~     participants will thereafter sign and date the informed consent form. This constitutes as~     visit 0.~      On visit 1, a randomization to either the standard or the modified irradiation protocol will~     be performed on one side of the face/body and the other irradiation protocol will then be~     applied on the other side of the face/body. The participants should have AKs on two~     comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be~     randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the~     other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo,~     Norway), which is the traditional lamp used at our department as mentioned above.~      The treatment will be given at visit 1. During the treatment, the participants will be asked~     continuously, every third minute, to estimate the pain on each treatment side using the~     visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the~     end of the treatment, the participants will also be asked to summarize the treatment as a~     whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form~     with questions regarding adverse effects (AEs) during the hours and days after the~     treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit,~     visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified~     irradiation protocol should be at least as good as the standard irradiation protocol. The~     randomization is blinded for the investigator at the FU visit to minimize the possibility of~     favoring one irradiation protocol.~   "
31547|NCT02644161|"~     An 8-week, assessor-blind, randomized controlled trial will be conducted. A total of 138~     patients with post-stroke depression (PSD) will be randomly assigned to the combination~     acupuncture treatment (CAI) (n = 69) or least acupuncture stimulation (LAS) (n = 69) for 3~     sessions per week for 8 weeks. Treatment outcomes will be measured using the 17-item~     Hamilton Self-Rating Depression Scale (HAMD-17), the Montgomery-Asberg Depression Rating~     Scale (MADRS), and Self-Rating Depression Scale (SDS) for depression symptoms; Barthel Index~     (BI) for physical function, the Montreal Cognitive Assessment (MoCA) for cognitive~     performance. The assessment will be performed at baseline and once monthly thereafter. The~     study will be conducted in School of Chinese Medicine Clinics, Tung Wah Hospital, Kowloon~     Hospital.~   "
31548|NCT02644148|"~     The current commonly used for distal gastri cancer in gastrointestinal anastomosis is~     Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which~     involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the~     result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic~     uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the~     continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our~     centre. Our previous results showed that this operation had a low postoperative complication~     and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe~     procedure. However, some limitations are noticed. The report from South Korea is a~     retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to~     perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to~     improve QOL of patients after laparoscopic distal gastrectomy.~   "
31549|NCT02644135|"~     This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent~     acute upper respiratory illness and respiratory virus infections. This study will be~     conducted at one site (University Hospitals Case Medical Center) in healthy adults during~     the upcoming respiratory virus season (12/15/11 to 3/14/12). The intervention will be with~     Halo, a commercial product which is FDA-approved for the treatment of xerostomia. The~     placebo will consist of the phosphate buffered saline plus the preservatives in the Halo~     formulation and without CPC - the active antiseptic. This placebo was chosen as the Halo~     formulation without CPC serves to act as a barrier to attachment of oral pathogens, and as~     such is an important contributing factor to its antimicrobial activity (see above). Also,~     the formulation without CPC with preservatives exhibits some antibacterial and antiviral~     activity. Moreover, the formulation without CPC and no preservatives is easily contaminated~     and not practical to utilize as the placebo in these studies.~      Male and female participants 18-45 years of age will be recruited and monitored for the~     development of, duration, and severity of clinical symptoms and signs consistent with acute~     respiratory disease (defined below) captured daily through diaries, and PCR confirmation of~     important respiratory viruses including influenza, rhinoviruses, adenoviruses, and~     respiratory syncytial virus during episodes of acute respiratory disease during the length~     of the study will be undertaken. Secondary objectives will assess the tolerance,~     acceptability and adherence to Halo as well as the change in the bacterial (oral~     streptococci and Group A streptococcus) and fungal microflora in the oropharynx. School or~     work absenteeism, visits to physicians' offices, emergency departments and urgent care~     centers will also be captured. Conventional cultures for these bacterial and fungal~     organisms will be pursued (see below). Throughout the study period, the safety,~     tolerability, acceptability and adherence to study products will be assessed.~   "
31550|NCT02644122|"~     The purpose of this study is to test the good and bad effects of an experimental drug called~     SF1126. This drug is being tested in patients whose cancer has not been controlled by~     available standard therapies and who have certain genes in their tumor.~      SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K).~     PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and~     metastasize. PI3K also has an important role in the development of blood vessels that are~     required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals,~     Inc. It is considered an experimental drug because it is not approved by the FDA for any~     disease treatment.~   "
31551|NCT02644109|"~     Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated~     primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous~     hepatic synthesis of cholesterol and its absorption at intestinal level. It has been~     demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins,~     which are the first treatment option for a moderate hypercholesterolemia.~      Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation~     into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment~     against low hypercholesterolemia. The target population are 40 to 65 years old individuals~     with low hypercholesterolemia.~   "
31552|NCT02644096|"~     Objective: The investigators hypothesized that all areas of health status after total hip~     replacement could be improved in patients aged over 65 years and over by using telephone~     support and counselling 2 and 10 weeks after surgery compared with a control group receiving~     conventional care and treatment.~      Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4~     weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65~     and over were randomised 4 weeks preoperatively to either control or intervention groups.~     Measurements: Both groups received conventional surgical treatment, but the intervention~     group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given~     counselling within eight main dimensions with reference to their postoperative situation.~      Key-words: THR - elderly patients - health status - postoperative support - counselling~   "
31553|NCT02644083|"~     The primary objective of this study is to test the hypothesis that DMF can improve~     mitochondrial function in the brain of people with MS. The investigators will assess~     mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic~     resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.~   "
31561|NCT02643979|"~     Propofol is one of the most popular anesthetic drugs used for sedation during upper~     gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms~     allowing patients to leave the hospital sooner. However, when administered it can also slow~     the breathing of patients and cause others to have upper airway obstruction (such as~     snoring) which can impede proper spontaneous breathing. Ketamine is an agent that is capable~     of providing both pain control and sedation while having either minimal effect on breathing~     or promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to~     reduce the total amount of Propofol used resulting in a procedure being performed under the~     same level of sedation but without the downside of reduced spontaneous breathing. Patients~     who are obese (defined as body mass index greater than 35) tend to be even more susceptible~     to this effect of Propofol. The researchers are investigating whether the addition of~     Ketamine will indeed allow for this continued comfortable level of sedation while promoting~     continued spontaneous breathing in obese patients undergoing upper gastrointestinal~     endoscopies.~   "
31554|NCT02644070|"~     The primary aim of the present multicenter randomized controlled trial was to evaluate and~     compare the shortterm clinical and histological changes of extraction sockets after ridge~     preservation procedures with changes of extraction sockets that healed naturally.~      The secondary aim was to evaluate which, if any extraction socket characteristics could have~     affected tissue changes occurring at the augmented as well as naturally healed sites.~      Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five~     university centers/private practice:~        -  University of Pisa;~        -  University of Murcia;~        -  University of Ancona;~        -  Private practice, Dr. Di Felice;~        -  University of Verona.~      Randomization:~        1. extraction sockets with spontaneous healing;~        2. extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine~          bone, with a particle size between 600 and 1000 μm;~        3. extraction sockets grafted with cortical porcine bone, with a particle size between 600~          and 1000 μm.~      Outcome Variables~        -  Complications~        -  Changes of ridge volume contour;~        -  Vertical bone changes;~        -  Buccal-Lingual Width;~        -  Histomorphometric parameters.~      Sample size was calculated comparing outcome data between grafted sockets versus non-grafted~     sockets. The primary parameter was the change in mid-buccal vertical height (0.7±1.4mm and~     3.6±1.5mm, respectively, for the test and control groups) (Barone et al. 2008). Final sample~     size was increased to 30 subjects per group due to possible patient dropout events. Each~     center contributed according to the predetermined 1:1:1 ratio; the fresh extraction socket~     was considered the unit of randomization.~      Corrections for balancing the three experimental groups for confounding factors were not~     applied.~      A matrix elaborator performed all the analyses§§: multi-way analysis of variance (ANOVAn)~     was applied, then appropriate post hoc comparison tests were run; post hoc estimated effect~     sizes were calculated with a power of 0.9. The level of statistical significance was set at~     0.05 for all analyses.~   "
31555|NCT02644057|"~     Heart failure is recognized as one of the most common indications for hospitalization~     amongst adults aged >65 years in United States with estimated Medicare cost to be 17 billion~     or more. Chronic heart failure is one of the most life threatening cardiovascular disorder~     thought to affect nearly six million US population with 600,000 new cases every year. The~     heart is responsible for perfusion to all vital organs including kidneys and dysfunction in~     either affects both the vital organs. When dysfunction of heart leads to dysfunction of~     kidneys or vice versa it is referred to as cardio renal syndrome (CRS). The underlying~     pathophysiology for CRS has been poorly understood and considered multifactorial. Worsening~     renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in~     20-30% of patients with ADHF and is associated with greater length of hospital stay,~     hospital readmission and death. A number of interventions have been used including giving~     diuretics which helps in decongestion and helps the heart pump blood more effectively.~     Sometimes these therapies are not effective and may even lead to worsening of renal~     function. In such cases , inotrope agents which increase the contractility of the heart have~     been used to help pump more blood to vital organs. There have been very few trials assessing~     the efficacy of these agents for improving kidney function .The investigators aim to assess~     the renal recovery with two such agents - dobutamine and milrinone in patients with~     cardiorenal syndrome who are coming with acute decompensated heart failure~   "
31556|NCT02644044|"~     Multiple sclerosis (MS) is characterized pathologically by demyelination, axonal loss, and~     glial scar formation. Clinically, most patients have a relapsing-remitting course of MS~     (RRMS) that over time may become progressive without remissions - a secondary progressive MS~     (SPMS). About 15% of patients have a progressive course from onset which is called primary~     progressive (PP).~      Currently, there is no approved treatment for PPMS and for SPMS only therapy with~     mitoxantrone showed mild effect. Thus, more effective therapies need to be developed for~     treatment of SPMS and PPMS.~      Methotrexate (MTX), an anti-metabolite, has been in clinical use since 1948 when it was~     found to produce temporary remission of acute childhood leukemia.~      There are accumulating evidences that in progressive MS patients there are follicular~     lymphoid structures in the meninges and in the Virchow-Robin spaces. Therefore, intrathecal~     therapy may target the pathological follicular lymphoid activity.~      The safety of intrathecal MTX (ITMTX) has been demonstrated by its widespread use in~     treating lymphoproliferative diseases and leptomeningeal metastases. Sadik et. Al. reported~     about the feasibility and safety of using intrathecal methotrexate (ITMTX) as a treatment~     for unresponsive patients with progressive forms of MS. In their open label study they found~     that ITMTX may have a beneficial effect in progressive forms of MS and that it was well~     tolerated with no serious adverse events.~      The investigators aim is to evaluate the efficacy , safety and tolerability of intrathecal~     methotrexate administration every 3 months in progressive 30 patients with progressive MS.~     The investigators will evaluate clinical, laboratory evaluation of the blood and~     cerebrospinal fluid as well as the MRI scans of the participants. Each patient will be~     treated 4 times for 1 year with the option to continue for another 1 more year with the same~     protocol.~   "
31557|NCT02644031|"~     Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are~     routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a~     complicated multi factorial process and is affected by factors related to patients, to the~     tooth and to the skills and experience of the dentist and because of that, if the~     interrelation of these factors is not considered in a PP, study data might be confusing. Any~     study trying to evaluate the effect of a specific technique or new device in the incidence~     or characteristics of PP should control all the confounding factors that have been described~     to be involved in the tested outcome.~      reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations~     are because of the differences in study methods, and treatment procedures after root canal~     treatment, selection of patients or experience and skills of the dentists, vary when~     different studies are compared.~      Many studies had confirmed that chemomechanical debridement of the root canal results in~     extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and~     root canal irrigants through the apical foramen. All preparation techniques and instruments,~     regardless of maintaining shorter working length of the apical terminus have reported to be~     related with extrusion of infected debris, and some of them extruded less material and~     others extruded more.~      Periapical inflammation and postoperative flare-ups may result from apical extrusion of~     debris that is also referred to as the worm of necrotic debris A common outcome of the~     studies examining the amount of apically extruded debris was that the techniques involving a~     push-pull filing motion usually produce a greater mass of apical debris than those have~     rotational action Files which has reciprocating and in-and-out filing motion, may act as a~     piston, extruding more debris and irrigants. While the file with continuous rotation motion~     like a screw conveyor improving transportation of dentinal chips and debris coronally.~      In this study, investigators compare post-endodontic pain between these two systems. Mtwo (~     continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of~     this study is Evaluation of post-endodontic pain after root canal treatment with two rotary~     systems: Mtwo & safe-sider~   "
31558|NCT02644018|"~     The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective~     and safe in the treatment of influenza and other acute respiratory viral infections in the~     course of standard therapy in 3-6 years old patients.~   "
31559|NCT02644005|"~     Prospective, bicentric observational study to assess a novel system for automated control of~     mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.~   "
31560|NCT02643992|"~     Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging.~     The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC~     concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be~     sufficient for all patients.~      Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the~     hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal~     perprocedural [DOAC], defined as [DOAC] < 30 ng/mL.~      Methods: Patients treated with DOAC, and requiring any invasive procedure will be included~     in this multicentre, prospective, observational study. [DOAC], will be measured during~     invasive procedure.~   "
31562|NCT02643966|"~     The purpose of this study is to evaluate the role of technologist-performed whole breast~     ultrasound for detecting breast cancer in the screening population of women with dense~     breasts.~   "
31563|NCT02643953|"~     Background: Nigeria has the second highest absolute number of maternal deaths and perinatal~     deaths in the world. The country contributes 14% of all maternal deaths worldwide, second~     only to India. Although all parts of the country are affected, most maternal, and perinatal~     deaths occur in the northeast and northwest geo-political zones, where women have limited~     access to evidence-based maternal and newborn health services. Affected women and families~     are mainly those who have little or no formal education, who are poor and marginalized, and~     who live in rural and sub-urban communities.~      Problem: Research carried out in various regions of Nigeria has shown that insufficient~     access to pregnancy health services is a major factor that places women at high risk of~     adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous~     local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching~     vulnerable women and their newborn infants, and PHC use is strongly encouraged by the~     Nigerian Federal Ministry of Health.~      Research Question and Objective: The key research question and objectives are as follows: 1)~     To determine the main factors that prevent vulnerable women from using PHCs or receiving~     maternal and neonatal care therein; 2) To identify effective community level interventions~     for improving women's access to maternal health services, as a means to reduce maternal and~     perinatal morbidity and mortality in Nigeria.~      Methodology: This study will complete a community-based, multi-site project using a mixed~     methods approach. The project will be done in three sequential phases: A data gathering~     phase (Phase 1), an intervention phase (Phase 2), and the implementation of the findings~     (Phase 3). The study will be conducted over 54-months in six communities, and another six~     communities of similar status will serve as control sites. During Phases 1-3, surveys about~     maternal health services utilization will be carried out at baseline, midterm and completion~     points of the project.~      Potential Impact: Increasing women's access to evidence-based maternity care is likely a~     direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will~     determine how we can effectively increase access to PHCs, and then bring those findings into~     a policy and program format that can be applied across the country.~   "
31564|NCT02643940|"~     This study will be recording pressure wire readings from both blocked and narrowed arteries,~     to better guide treatment options; medications, stents or potentially bypass surgery, for~     patients with Chronic Total Occlusion (CTO).~   "
31565|NCT02643927|"~     The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol~     based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened~     version of the protocol in the improvement of wellbeing variables in a non-clinical~     population in Spain. The investigators initial hypothesis was that both protocols are~     efficacious but the standard 8-week performs better that the short one.~   "
31566|NCT02643914|"~     Nicotine is the most common drug of abuse in the United States, and has addiction strength~     comparable to cocaine, heroin, and alcohol. It is the primary addictive component of~     tobacco, and its use markedly increases risk for cancer, heart disease, asthma, miscarriage,~     and infant mortality. Addiction is thought to be caused primarily by the intersection of two~     components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and~     2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be~     used qualitatively within the neuroscience literature, regulation has a precise and testable~     meaning in control systems engineering, which has yet to be addressed in a quantitative~     manner by current neuroimaging methods or models of addiction. Current approaches to~     neuroimaging have primarily focused on identifying nodes and causal connections within the~     meso-circuit of interest, but have yet to take the next step in treating these nodes and~     connection as a self-interacting dynamical system evolving over time. Such an approach is~     critical for improving our understanding, and therefore prediction, of trajectories for~     addiction as well as recovery.~   "
31567|NCT02643901|"~     This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic~     (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.~   "
31568|NCT02643888|"~     The main task of this study includes analyses of the BCR-ABL1 (breakpoint cluster~     region/Abelson) gene and mutations in the BCR-ABL1 tyrosine kinase domain within flow-sorted~     stem cells from the bone marrow and/or peripheral blood specimens. To assess the germline~     configuration of the patient, DNA from fingernail clippings will be investigated.~   "
31569|NCT02643875|"~     Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas~     permeable contact lens exerting positive pressure on the central cornea to temporary reduce~     refractive error. The investigators have shown that this treatment is effective for myopic~     control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses~     in the market are fitted based on the Jessen formula. The compression factor was introduced~     to compensate for regression of the ortho-k effect during the no lens-wear period, so that~     the wearer can obtain clear distance vision throughout the day and most lens designs use a~     compression factor of 0.50-0.75D. However, in a retrospective study (mixed brands of ortho-k~     lenses), showed that most patients did not achieve an over-correction of 0.75D. In order to~     achieve an over-correction of 0.75D, an extra flattening power of about 1.50D instead of~     0.75D should be be targeted. The increased compression factor is expected to increase the~     target reduction and it may play a role in myopic control and providing a higher successful~     rate in fitting ortho-k lenses.~   "
31570|NCT02643862|"~     This is a pilot randomized, double-blind, placebo controlled study which will be conducted~     at a single center. All participants will receive oral immunotherapy for their specific food~     allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36~     participants will receive Xolair for 16 weeks while 12 will receive corresponding placebo~     instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair.~   "
31571|NCT02643849|"~     The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract~     symptoms in subjects to achieve bladder drainage in men unfit for other treatments.~   "
31572|NCT02643836|"~     The objectives are to evaluate impact of Pulsed electromagnetic field (PEMF) therapy on~     patients with Post-Concussive Syndrome with Rivermead Post Concussion Symptom Questionnaire~     (RPQ) as a primary outcome, followed by fatigue and mood as second and tertiary outcomes~     respectively. The investigators will also investigate brain tissue activity and oxygenation~     by evaluating brain wave activity via non-invasive quantitative electroencephalogram and~     near infrared spectroscopy testing pre and post study to better understand the metabolic~     effect of the PEMF intervention.~      The investigators hypothesize that the PEMF treatment will have an effect on improvement of~     brain metabolism as measured by Near Infrared Spectroscopy which will in turn assist with~     improvement of the chronic symptoms of cognitive deficits, mood and fatigue as related to~     Post-Concussive Syndrome.~   "
31573|NCT02643823|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.~   "
31574|NCT02643810|"~     In this controlled trial, patients with tetralogy of Fallot will be randomized to either~     interval training, continuous training, or usual care groups.~   "
31667|NCT02642601|"~     the aim of the study is to assess the role of indomethacin in cases of difficult embryo~     transfer in intracytoplasmic sperm injection cycles.~   "
31578|NCT02643758|"~     The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low~     addition and nasally decentered optical zone are effective in controlling myopic progression~     in children. Visual manipulations induced by multifocal soft CLs with high addition have~     been shown to inhibit eye growth and myopia development in children by recent studies.~     Several theories have been proposed including alteration in peripheral defocus, reduced~     accommodation demand, alterations in binocular vision status and increased ocular higher~     order aberrations. However, those theories remain to be proven and the optical properties~     and performance of multifocal soft CLs have not been investigated in children.~   "
31579|NCT02643745|"~     Acute kidney injury (AKI) is a frequent complication after cardiac surgery. Its incidence~     ranges from 19 to 44% depending on the study and which definition is used: Acute Kidney~     Injury Network (AKIN) classification or RIFLE criteria (Risk, Injury, Failure, Loss,~     End-Stage Kidney Disease) based on serum creatinine and urine output.~      AKI is associated with increased mortality, more complications, a longer stay in the~     intensive care unit and hospital, and increased health care costs. Moreover, the patients~     who require renal replacement therapy (RRT) have the highest mortality and~     complications1.The mortality risk in patients developing acute renal dysfunction after~     cardiac surgery increases by approximately 40%, while the overall mortality rate after~     cardiac surgery ranges between 2% and 8%.~      There are some well-known risk factors associated with AKI, including baseline patient~     characteristics (age and comorbidities), need of perioperative blood transfusion or presence~     of previous chronic kidney disease. The main objective of this study is to evaluate if a~     nephrologist management and control of potential risk factors of renal disease can be used~     to prevent AKI, thereby minimizing the risk of need RRT, reducing costs and improving~     survival in this patients.~   "
31580|NCT02643732|"~     This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for~     clinically-significant fatigue in sarcoidosis patients with stable disease. The primary~     outcomes are feasibility, aimed at determining factors that will influence the design a~     future, larger RCT, which will be powered to look at clinical efficacy of the intervention.~   "
31581|NCT02643719|"~     Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment~     for migraine in the Emergency Department (ED) and prescribing migraine preventive~     medications in the ED. The study will examine the effect of these treatments, both~     individually and in combination, on pain severity and headache-related disability. This~     study is designed to examine the feasibility of comparing four interventions for ED patients~     presenting with migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral~     intervention; Group 3: Treating with combination therapy of topiramate and behavioral~     intervention; and Group 4: Standard of Care.~   "
31582|NCT02643706|"~     The purpose of this clinical trial is to investigate the relationship between the gene~     polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.~   "
31583|NCT02643693|"~     This study will provide an initial assessment of the acceptability of the Nicotine Lactate~     Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC)~     smokers to use P3L to maintain their customary nicotine intake.~      The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will~     be evaluated as well as the safety and tolerability of the P3L.~   "
31584|NCT02643680|"~     1. The wound healing time of STSG donor sites which are treated with the novel~          biocellulose wound dressing containing silk sericin and PHMB should be less or equal to~          Bactigras®.~        2. The wound quality of STSG donor sites which are treated with the novel biocellulose~          wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.~        3. The amounts of STSG donor site infection which are treated with the novel biocellulose~          wound dressing containing silk sericin and PHMB should not be more than Bactigras®.~        4. The pain level of STSG donor sites which are treated with the novel biocellulose wound~          dressing containing silk sericin and PHMB should be less or equal to Bactigras®.~        5. Adverse events which are occurred from the novel biocellulose wound dressing containing~          silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported,~          if they occur.~   "
31585|NCT02643667|"~     Multicenter phase 1/2 study of neoadjuvant Ibrutinib in men with localized prostate cancer~     undergoing RP as their initial locally directed therapy with curative intent. To assess the~     immune response following neoadjuvant treatment, tissue from RP specimen will be compared to~     tissue from core biopsy specimen obtained prior to treatment, with each subject serving as~     his own control. Immune infiltration will also be compared to a reference cohort of 12~     patients who had undergone RP, matched to the study population using the UCSF CAPRA-S score.~   "
31586|NCT02643654|"~     Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab~     is recently licensed for moderate to severe HS, many cases fail to respond or relapse during~     treatment. Favorable outcomes from a recently conducted double-blind randomized clinical~     study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis~     suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in~     these cases.~   "
31587|NCT02643641|"~     BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different~     recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This~     prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of~     allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the~     grass pollen season.~   "
31588|NCT02643628|"~     This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and~     safety of microneedling treatment alone vs. microneedling treatment followed by treatment~     with Bellafill for correction of distensible atrophic facial acne scars.~   "
31614|NCT02643290|"~     Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis~     Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic~     pain secondary to scoliosis.~      20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample~     size was calculated considering the data collected during the development of the brace in~     the US. Patients will be evaluated at baseline immediately before starting with the brace~     and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day.~      At each evaluation they will be asked to fill the questionnaires, to be used as outcome~     measure of the results.~   "
31589|NCT02643615|"~     Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent~     but severe complication. Little is understood about this complication, but most cases seem~     to result from loss of blood flow to the optic nerve. This is a pilot, single center,~     prospective, randomized, two-arm study involving 20 subjects at The Ohio State University~     Wexner Medical Center who are scheduled to undergo spine surgery that requires prone~     position and at least two hours of general anesthesia or total intravenous anesthesia (TIVA)~     and intraoperative neurophysiological monitoring. Patients will be randomized to either~     general anesthesia or TIVA, and wear the SightSaver device to monitor visual evoked~     potentials (VEPs) during surgery in order to detect possible changes in optic nerve function~     that may lead to POVL. We hypothesize that this new, flexible, disposable device will yield~     better results and more patient satisfaction than devices currently used for visual~     monitoring during prone spine surgeries.~   "
31590|NCT02643602|"~     Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired~     acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in~     the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is~     administered to the patients especially in patients with already existing renal impairment.~     Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium~     chloride alone. The combination of the two prophylaxis has not been investigated yet.~      Aim of this prospective randomized trial is to investigate the effect of hydration with~     sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all~     patients receive.~   "
31591|NCT02643589|"~     The purpose of this study is to compare the incidences of GVHD in haploidentical~     hematopoietic stem cell transplant recipients receiving different dose of antithymocyte~     globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators'~     first objective was to investigate the optimal dose of ATG for aGVHD.~   "
31592|NCT02643576|"~     This highly innovative experimental trial is designed to examine the independent and joint~     effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary~     calories and offering an incentive to encourage the purchase of more healthful foods.~   "
31593|NCT02643563|"~     Severe pain following shoulder surgery is common and remains a major challenge. The~     interscalene nerve block is well suited for operations on the shoulder or upper arm, for~     providing surgical anesthesia as well as prolonged effective postoperative analgesia.~      Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local~     anesthetic. The current trend is to lower the volume of local anesthetic for~     ultrasound-guided interscalene block in order to reduce potential complications such as~     phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic~     duration of the block could be compromised. Studies to elucidate the best local anesthetic~     agent, concentration and adjuncts to prolong analgesia at low volumes are needed.~     Ropivacaine and Bupivacaine are long acting local anesthetics commonly used for peripheral~     nerve blocks, however, there are no studies comparing their analgesic duration in the~     setting of low volume interscalene block to date.~      This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5%~     Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB.~      This study aims to conduct a comparison of the duration of post operative analgesia achieved~     by these agents, hence allowing the appropriate local anesthetic agent and concentration~     selection in low-volume techniques.~   "
31594|NCT02643550|"~     The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses~     of IPH2201 given IV in combination with cetuximab in patients who have received prior~     systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and~     neck (SCCHN). A cohort expansion will evaluate antitumor activity of the combination.~   "
31595|NCT02643537|"~     The aim of this study was to evaluate the clinical outcome of this rare injury with special~     emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the~     diagnosis of associated pathologies following LEH.~   "
31596|NCT02643524|"~     The purpose of the study is to determine if patients wearing a CAM walker boot for a minimum~     of 6 weeks have a change in weight compared to patients who wear a CAM boot for a minimum of~     6 weeks and are provided nutritional and upper body exercise information.~   "
31597|NCT02643511|"~     Whole gland LDR brachytherapy has been a well established modality of treating low risk~     prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to~     surrounding organs.~      AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment~     for localized prostate cancer demonstrating the feasibility of the delivery of the~     prescription dose to the half of the prostate in terms of meeting standard dosimetric~     parameters while respecting same or lower tolerance doses of adjacent normal organs.~      To determine acute and late rectal, urinary and sexual toxicity after this procedure.~      To assess the change from baseline in QOL indicators at specific time intervals using~     validated international questionnaires [International Prostate Symptom Score ( IPSS),~     International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)]~     after this treatment.~      To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy~     36 months after the treatment.~      To compare target coverage and relative doses to the rectum and the urethra for the same~     patient performing a hemigland treatment planning vs Whole gland treatment planning.~      STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative~     treatment with LDR for prostate cancer is dosimetrically safe and feasible.This study will~     record data for 20 patients with ipsilateral with low and low tier intermediate risk~     disease.The study will record quality of life parameters in particular in terms of urinary,~     rectal and sexual function side effects.~      INTERVENTION:~        -  Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not~          required if already performed)~        -  Multiparametric MRI within the 3 months prior to registration and at 18 & 36 months.~        -  Hemigland prostate region will be targeted with the prescription dose and receive 144~          Gy of Iodine125 (I125).~        -  The quality of life assessment will focus on erectile function, urinary function, bowel~          function, and general health related quality of life~        -  Postimplant CT Planning day 30 after the implant for quality assurance.~      MEASUREMENT OF ENDPOINTS :~      Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies~     at 36 months to assess local control.~   "
31598|NCT02643498|"~     The purpose of this study is to find out the maximum dose of SBRT that can be safely given~     after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.~   "
31599|NCT02643485|"~     Static pedobarography is routinely used for pre- and postoperative questions regarding~     plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence,~     dynamic pedobarography might give some important insights in detecting plantar foot pressure~     after forefoot reconstruction.~   "
31628|NCT02643108|"~     Primiparae with a live singleton pregnancy in cephalic presentation past 34 gestational~     weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal~     delivery is indicated. Primary outcome is obstetric anal sphincter injury (OASIS) of any~     degree.~   "
31600|NCT02643472|"~     BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU)~     care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be~     classified as children with special health care needs (CSHCN) who will require health and~     related services of a type or amount beyond that required by children generally. NICU~     parents report increased anxiety and stress during their stay and transition home from the~     NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and~     depression for mothers, however, no studies have evaluated the effects of long term~     post-discharge peer support. Children's National (CN) provides medical home services to~     CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents~     who provide peer emotional support, access to community resources, and assistance with~     navigating complicated health systems. NICU graduates and their caregivers may benefit from~     support provided by PNs after discharge. No data regarding the impact of PNs on patient and~     family outcomes of the NICU graduate are available.~      OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety,~     depression; infant health care utilization, and immunization status.~      METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months~     (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and~     12 months after discharge will be collected from caregivers in both groups including scales~     for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and~     immunization status. Outcomes will be compared at 12 months.~      PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety,~     and depression; infant health care utilization and immunization status.~      ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in~     the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support~     after discharge, when a family is faced with the total care of their child without~     structured supports, can significantly impact parents' ability to care for their child. The~     investigators anticipate that this simple intervention will increase self-efficacy in~     caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health~     outcomes for their child.~   "
31601|NCT02643459|"~     Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms~     is supplemented with a prognostic biomarker?~   "
31602|NCT02643446|"~     The Purpose of this study is to assess the seroconversion using inactivated poliovirus~     vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV~     was phased introduced into national immunization program (NIP) in China.~   "
31603|NCT02643433|"~     Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability~     in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over~     other JE vaccines such as one dose schedule, using for infants, and the cheaper cost.~     Because the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it~     will likely be used in other countries, and possibly co-administered with the first dose of~     measles-containing vaccine (MCV) to ensure early protection and reduce additional~     vaccination visits.~      The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited.~     Only one study conducted in the Philippines examining the co-administration of MCV with LJEV~     among 9 months infants, the results showed the proportion of achieved sero-protection~     against measles following MCV (96%) was slightly lower than in the MCV-only group (100%),~     and the measles antibody titres were also slightly lower in the co-administration group. Due~     to limited evidence available, the WHO position paper of measles vaccines has encouraged~     further investigation on the possible impact of co-administration of LJEV on measles vaccine~     effectiveness.~      In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age~     nationally. Considering China is reaching towards the goal of measles elimination, it will~     be important to conduct a study to compare the immunogenicity of MR administered alone or~     with LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among~     8 months infants.~      This study is a prospective, randomized, open-label, multi-center study enrolling infants~     aged 8 months. Basic demographic information of the infant will be taken and blood samples~     will be collected at enrollment (baseline) and at 6weeks following administration of MR, the~     measles antibodies will be measured, and compare seroconversion rates to assess for~     non-inferiority. All infants will be monitored for adverse events after MR.~   "
31604|NCT02643420|"~     The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with~     pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with~     early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the~     Duration of Severe Neutropenia (DSN) in Cycle 1.~   "
31605|NCT02643407|"~     To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus~     cisplatin in managment of advanced/relapsed squamous cell lung cancer.~   "
31606|NCT02643394|"~     The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the~     management of postoperative pain is understudied and largely unknown. In this observer~     blinded randomized clinical trial, investigators aim to determine the comparative efficacy~     of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.~   "
31607|NCT02643381|"~     Patients who are having problems breathing sometimes require placement of a breathing tube~     in their mouth and windpipe. The purpose of this breathing tube is to save the patient's~     life. It is common to give the patient a medication to sedate him or her before the~     breathing tube is placed. For patients who are gravely ill two medications are commonly~     used: etomidate or ketamine. Both medications have risks and benefits. Researchers at~     UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to~     figure out which one is better for our patients.~   "
31608|NCT02643368|"~     This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along~     with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the~     interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity~     when the first dose of mOPV2, in a two dose schedule with a four week interval, is~     administered simultaneously with IPV.~   "
31609|NCT02643355|"~     Withdrawal from opioids is a clinical scenario that emergency department physicians~     encounter frequently. Patients who present with opioid withdrawal display symptoms such as~     agitation, anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the~     standard treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as~     well as supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical~     antipsychotic that is given frequently in the ED for many of the same symptoms that are seen~     in patients who are experiencing opioid withdrawal, however its use in this toxidrome has~     never been studied. The hypothesis of this study is that olanzapine is a safe and~     efficacious option when compared to clonidine for the treatment of opioid withdrawal in the~     emergency department.~   "
31610|NCT02643342|"~     This is a two-year longitudinal study investigating the optical and structural effects of~     increased compression factor of orthokeratology lens on eyes and the corresponding effect on~     change in choroidal thickness and therefore myopic control.~   "
31611|NCT02643329|"~     The purpose of the study is to compare the bioavailability of a generic product of~     gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future~     Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of~     reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires~     Servier Industrie, France) when administered to healthy volunteers under fasting conditions.~     The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to~     access the interchangeability of the products.~   "
31612|NCT02643316|"~     Comparison of quality of preparation of colonoscopy in patients taking same day 4L~     preparation vs. 4 L split dose preparation in patients scheduled for an afternoon~     colonoscopy procedure.~   "
31615|NCT02643277|"~     In India, the high diabetes prevalence and cost of its management relative to their personal~     income render the country an appropriate environment to seek and test new, less expensive~     aids to care. Education and motivation to induce behavioural modification, are important~     components of care. Conventional diabetes education programmes involving personal contact~     methods are useful but expensive. Compliance with medications is also important and there~     are data to suggest that compliance is low in people with established type 2 diabetes (there~     is little information on those with recently diagnosed disease). Mobile phones could provide~     an inexpensive and scaleable delivery vehicle for components of care. There are now more~     than 5 billion wireless subscribers and 70% of them live in low and middle income countries.~     Mobile phone ownership is high in India and an increasing proportion now has Mobile phones~     and/or home computers. The investigators plan a clinical trial in India to assess whether~     there is benefit from an enhanced text message intervention delivered by mobile phone in~     people newly diagnosed with Type 2 diabetes. The message content will be directed to~     behavioural modification, as with our diabetes prevention studies, and will attempt to~     improve compliance with drug therapy and other aspects of care, as with our studies in~     people with established diabetes. The investigators shall compare effects on glycaemia,~     other cardiovascular risk factors, lifestyle behaviour and quality of life, with those~     observed in people with type 2 diabetes receiving standard care.~   "
31616|NCT02643264|"~     The purpose of this study is to investigate the effects of repetitive transcranial magnetic~     stimulation (rTMS) targeting the insula on alcohol use and neural responses in~     alcohol-dependent patients.~   "
31617|NCT02643251|"~     The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up~     Phase. Subjects who qualify to participate will apply study drug to their feet three times~     daily and will record their daily pain scores using an interactive voice response system~     (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be~     randomized to receive Clonidine Gel or Clonidine Gel Comparator.~   "
31618|NCT02643238|"~     The purpose of this study is to evaluate the use of an artificial vision system called~     Brainport system in blind patients To investigate visual, and oculomotor (eye motion)~     mechanisms involved in the use of the Brainport system.~   "
31619|NCT02643225|"~     The aim of this work is the prediction of fetal macrosomia by measuring:~        1. HbA1C.~        2. Umbilical cord thickness.~        3. Interventricular septum thickness.~   "
31620|NCT02643212|"~     The main objective of the study will determine if patients with liver cirrhosis,~     anticoagulation free survival improves hypertension decompensation portal and / or~     transplantation without serious side effects. For it is conduct a double-blind multicenter~     clinical trial in which patients will be randomized to receive Rivaroxaban or placebo. It~     included 160 patients with liver cirrhosis and insufficiency mild to moderate hepatic. It~     will also analyze and develop secondary endpoint portal vein thrombosis. The confirmation of~     our hypothesis would lead to a radical change in treatment of patients with cirrhosis~     include treatment with Rivaroxaban in its drove.~   "
31621|NCT02643199|"~     The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the~     fetal heart from 34-36 weeks of gestation.~   "
31622|NCT02643186|"~     The study aims at comparison between the effect of preoperative misoprostol and bilateral~     uterine artery ligation regarding their effect to decrease blood loss in transabdominal~     myomectomy.~   "
31623|NCT02643173|"~     The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to~     the main anesthetic agents used for the general anesthesia.~   "
31624|NCT02643160|"~     The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower~     extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to~     analyze the relation between trunk control and prematurity, birth weight, upper and lower~     extremity motor functions in children with spastic Cerebral Palsy.~   "
31625|NCT02643147|"~     Worsening renal function (WRF) is a frequent finding in patients with decompensated acute~     heart failure (AHF) and it is associated to increased length of hospitalization and higher~     morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low~     cardiac output, but recent evidence also suggests venous congestion play a crucial role.~     Loop diuretics are the mainstay treatment of AHF, but their use traditionally has been~     associated to WRF, but also renal function improvement in patients with unequivocal signs of~     congestion. Nevertheless, traditional symptoms or signs of patients with AHF have shown a~     limited accuracy to neither identify nor quantify the degree of venous congestion. Recent~     authors have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely~     related to the degree of venous congestion.~      The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated~     (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values~     needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to~     evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard~     strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72~     hours after initiation of intravenous diuretic in an acute worsening of heart failure~   "
31626|NCT02643134|"~     The traditional stone row method comprises increasing exercise, drink lots of water, drug~     row of stone and stone row position. External physical vibration lithecbole(EPVL) is a~     non-invasive device active row of stone, the researchers hope that through this test~     prospective clinical study to evaluate the effectiveness of in vitro physical vibration row~     of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged,~     thereby improving after ESWL stone clearance rate.~   "
31627|NCT02643121|"~     Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of~     monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding~     protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in~     the production of numerous pro-inflammatory cytokines. Following Presepsin activation by~     bacterial products, the CD14 complex is released in the circulation as its soluble form~     (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called~     sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated~     chemo-luminescent assay (PATHFAST).~   "
31668|NCT02642588|"~     Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue~     level will be compared to women receiving usual practice care i.e. clear liquids only.~   "
31631|NCT02643069|"~     Frailty is the main risk factor for the development of incident disability in older people~     and one of the most important for other adverse outcomes (death, hospitalisation, falls, and~     permanent institutionalisation).~      Although frailty is a frequent condition in older adults who attend hospitals, little is~     known about its true prevalence in different settings of care. Better knowledge of this~     issue will inform the rational design of more effective strategies aimed at providing fitted~     care for these patients. Thus, the current study will potentially have impact on the quality~     of care for frail patients by revealing the prevalence of frailty in different settings of~     care, the difficulties in detection and management of frailty in these settings and the best~     instruments to detect frailty.~      The investigators proposal brings together 6 partners in the European Union (EU) from three~     countries, with the common aim of studying the feasibility of a program to detect frail~     older patients in high risk clinical settings.~   "
31632|NCT02643056|"~     Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety~     profile of panitumumab in patients affected by Head and Neck cancer after at least one~     cisplatin or carboplatin-based chemotherapy. A translational research study is also planned~     to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA~     sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse~     hybridization.~      Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive~     disease, unacceptable toxicity, pregnancy, or patient's refusal~   "
31633|NCT02643043|"~     This comprehensive genomic analysis and biospecimen repository study incorporates Next~     Generation Sequencing (NGS) of archival tumor tissue from 200 subjects with metastatic~     urothelial cancer in support of several parallel goals. The immediate goal involves~     generation of a comprehensive report identifying subject specific genetic mutations and/or~     alterations based on NGS. Once NGS is complete, DNA and RNA extracted from the specimens and~     any remaining blocks/slides/curls will be stored for future research. Long-term, the goal of~     this endeavor is to support collaborative translational research projects in metastatic~     urothelial cancer by allowing investigators to interrogate abstracted coded clinical data~     linked to data from any biospecimen studies.~   "
31634|NCT02643030|"~     The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and~     cerebral oxygenation during shoulder arthroscopy.~   "
31635|NCT02643017|"~     Investigate the effects of dexmedetomidine on postoperative cognitive function in patients~     undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.~   "
31636|NCT02643004|"~     The objective of this study is to compare the clinical performance of senofilcon A lens with~     the stenfilcon A lens each for one week of daily disposable wear.~   "
31637|NCT02642991|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
31638|NCT02642978|"~     The purpose of this study is to evaluate the safety and effectiveness of robot-assisted~     simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver~     metastases, and compared with the traditional open procedure.~   "
31639|NCT02642965|"~     This phase I/II trial studies the side effects and best dose of liposomal~     cytarabine-daunorubicin CPX-351 (CPX-351) when given with fludarabine phosphate, cytarabine,~     and filgrastim and to see how well they work in treating younger patients with acute myeloid~     leukemia that has come back after treatment (relapsed) or is not responding to treatment (is~     refractory). Liposomal cytarabine-daunorubicin CPX-351 is made up of two chemotherapy drugs,~     cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking~     the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may~     increase the production of blood cells and may help the immune system recover from the side~     effects of chemotherapy. Giving liposomal cytarabine-daunorubicin CPX-351 followed by~     fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients~     with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common~     effect of other chemotherapy treatments for acute myeloid leukemia.~   "
31640|NCT02642952|"~     The purpose of this study is to evaluate by non-invasive methods the change in central~     hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic~     aneurysm repair.~      Our main goal is to measure the changes in:~      Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.~   "
31641|NCT02642939|"~     This is a non-randomized, multicenter, single-stage phase II study of mifepristone in~     patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy~     regimens.~      The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22~     evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be~     followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median~     progression free survival time of 10 weeks and overall survival of 10 months. The~     Investigator would like to provide evidence that mifepristone will increase the median~     progression-free survival time to 15 weeks and overall survival time of 16 months.~   "
31642|NCT02642926|"~     Since the development a few years ago of bipolar energy in the surgery by operative~     hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be~     achieved either by the use of monopolar or bipolar current, in parallel with other~     techniques labelled as 'second generation' (microwave, radio frequency, thermal destruction~     ...) treating the uterine cavity.~      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective~     data on the success rate after bipolar endometrial ablation are poor and there is currently~     no recommendation as to the choice of technique to use. No prospective assessment exists to~     date in the literature to compare the difference in efficacy on bleedings when using~     monopolar or bipolar current. The goal of this study is to compare these two energies, by~     measuring the amount of bleeding calculated by the Higham score 12 months after the~     intervention.~   "
31669|NCT02642575|"~     The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of~     ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D~     ultrasound~   "
31643|NCT02642913|"~     The purpose of this study is to test the safety of enzalutamide with or without sorafenib at~     different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the~     treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen~     receptor. Experiments on liver cancer cells and animal models show that blocking the~     androgen receptor causes liver cancer to stop growing. Enzalutamide has not been approved to~     treat liver cancer. The investigators want to see if enzalutamide is safe for patients with~     liver cancer who have had their tumors grow on sorafenib. The investigators also want to see~     how safe and effective sorafenib and enzalutamide are for liver cancer patients that have~     never been treated with sorafenib. This is the first time enzalutamide and sorafenib are~     being used together. This treatment may not help treat the participant's cancer.~   "
31644|NCT02642900|"~     Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are~     several treatment options for this condition, including the use of antifungal agents such as~     nystatin and miconazole. The side effects and the increasing number of resistant species~     caused by the use of these drugs encourage the development of alternative therapies.~     Photodynamic Therapy (PDT) has been used as a promising treatment of stomatitis. In this~     randomized clinical trial, the effectiveness of PDT was evaluated. Patients in this study~     were allocated to two groups. One group was treated with nystatin, and the other group was~     treated with PDT.~   "
31645|NCT02642887|"~     Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival~     recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel~     technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).~      Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two~     isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG~     and cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months~     postoperatively. The primary outcome was root coverage esthetic scores (RES).~   "
31646|NCT02642874|"~     Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly~     effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle~     spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the~     inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide~     range of safe and effective dosages.~   "
31647|NCT02642861|"~     Although a number of mechanisms for cramps in liver disease have been postulated and have~     been targeted by medical therapies, a clear picture of the causal events has not emerged.~     Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and~     branched-chain amino acids have shown some benefit in small uncontrolled studies, although~     large randomized controlled trials are lacking.~      - Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It~     is one of the best-studied drug for this application.~   "
31648|NCT02642848|"~     The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem~     cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as~     conventional microfracture surgery on injured cartilage has a disadvantage of the~     replacement by fibrocartilage, this research intends to prove the excellence over the~     conventional therapy by proving a hyaline cartilage regeneration of injured cartilage by~     stem cell.~   "
31649|NCT02642835|"~     Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous~     women. The socioeconomic, psychological and physical impacts of prolapse are considerable.~     11% of women will undergo a surgical repair by the age of 80 years. The commonest~     compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate~     of recurrent prolapse or a failure of the primary procedure. This has lead to the~     introduction of new techniques and the use of different materials to augment the repair.~     Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of~     synthetic mesh is associated with complications which are not found in non mesh repairs. 10%~     of women will have a mesh complication of which 70% will require a further surgical~     procedure to manage the complication. There are extra costs associated with purchasing the~     mesh, with longer operating times to insert the mesh and managing complications caused by~     the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of~     the most contentious issues in urogynaecology at the present time.~      Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in~     the use of mesh to support the vaginal wall in prolapse surgery due to risks and~     complications being reported. To date there is little evidence regarding the long term~     safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for~     Perigee.~   "
31650|NCT02642822|"~     In this study, 100 female students aged 18 to 30 years old in Xiamen University will be~     enrolled. On the first visit, blood, saliva and urine samples of all participants will be~     collected. Then saliva and urine samples will be collected at two-week interval until 6~     months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be~     used to test CMV DNA by PCR. The primary purpose of this study is to identify the~     relationship between baseline PP150-IgG titer and CMV infection.~   "
31651|NCT02642809|"~     The investigators propose to treat patients with metastatic esophageal cancers and dysphagia~     with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is~     hypofractionated and will provide a radiation dose of sufficient intensity to induce the~     release of tumor-derived antigens and trigger an antitumor immune response. The simplicity~     of the design should maximize the chance to examine the hypothesis that radiotherapy can~     induce an immune response, which can then be augmented by pembrolizumab treatment. Success~     in this study would provide the impetus to conduct further trials aimed at developing this~     unique strategy as a more broadly applicable therapeutic option in the treatment of patients~     suffering from these deadly cancers, and will provide important mechanistic insights into~     the relationship between radiation treatment and immune therapy augmentation.~      Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers~     in combination with radiation therapy may be a rational treatment strategy for these~     cancers.~   "
31652|NCT02642796|"~     Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve~     stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.~   "
45651|NCT02459470|"~     The aim pf this prospective study is to investigate the ability of stroke volume variation~     (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients~     undergoing kidney transplantation.~   "
31653|NCT02642783|"~     Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte +~     ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen,~     France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and~     oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the~     manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N=~     14) to create a sensory profile for the solutions and generated attributes were rated on an~     unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory~     evaluation software. Acceptability testing was carried out with untrained participants~     (N=80) and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right~     (JAR) scale was included for the four basic tastes to determine their compatibility with~     optimum taste/acceptability levels in the products.~   "
31654|NCT02642770|"~     Patients presenting with Left Ventricle (LV) dysfunction undergoing cardiac surgery are at~     increased risk of perioperative morbidity and mortality. LV dysfunction has been reported as~     an independent predictor of operative mortality in patients undergoing Cardiac surgery. It~     also often leads to low cardiac output states with many of these patients requiring~     inotropic or mechanical support and vasopressors for hours to days after surgery. Speckle~     tracking when combined with three dimensional (3D) imaging techniques might prove to be a~     more sensitive marker for ventricular dysfunction. The present study investigates early~     outcomes in a consecutive series of patients with LV dysfunction undergoing cardiac surgery~   "
31655|NCT02642757|"~     This study evaluates the effectiveness of a brief intervention for the reduction of alcohol~     use among risky alcohol users in primary care delivered by paramedics. Half of the~     participants will receive a brief intervention and half will receive written guidelines on~     safe alcohol use.~   "
31656|NCT02642744|"~     This study will examine if the attending nurse model will enhance critical patient-centered~     elements of care that will in turn improve patient education and shared decision-making,~     medication adherence, stroke-related health literacy, and reduce early readmissions to~     ultimately yield improved patient quality of life. Our primary objective is to determine~     whether the attending nurse model of care improves stroke patients' health at 7 days, 30~     days, and 90 days after hospital discharge as assessed through questionnaires.~   "
31657|NCT02642731|"~     Sensitive renal markers have been studied abundantly in connection with open heart, liver~     and transplantation surgery; however in major orthopaedic surgery their use is anecdotal.~     The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil~     gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type~     fatty acid-binding protein), and IL-18 (interleukin -18), in patients without kidney~     deterioration undergoing TKA (total knee arthroplasty) as a pilot study before large study~     concerning acute kidney injury in orthopaedic surgery.~   "
31658|NCT02642718|"~     Background: Experimental models using short duration noxious stimuli have led to the concept~     of pre-emptive analgesia. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), has~     been shown to have a post-operative narcotic sparing effect when given pre-operatively and~     alternatively to not have this effect. This study was undertaken to determine whether a~     single intravenous dose of ketorolac would result in decreased post-operative pain and~     narcotic requirements.~      Methods: In a double-blind, randomized controlled trial, 48 women undergoing abdominal~     hysterectomy were studied. Patients in the ketorolac group received 30 mg of intravenous~     ketorolac 30 minutes before surgical incision, while the control group received normal~     saline. The post-operative analgesia was performed with a continuous infusion of tramadol at~     12 mg/hour with the possibility of a 10 mg bolus every 10 minutes. Pain was assessed using~     the Visual Analog Scale (VAS), tramadol consumption and hemodynamic parameters at 0, 1, 2,~     4, 8, 12, 16 and 24 hours post-operatively. We quantified times to rescue analgesic~     (morphine), adverse effects and patient satisfaction.~   "
31659|NCT02642705|"~     The present study aims at evaluating the effect of two innovative treatment strategies in~     obese patients: high intensity interval training and hypoxic conditioning. Obese patients~     will be randomized in groups performing high intensity interval training, constant load~     training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of~     the interventions will be measured regarding exercise tolerance, blood pressure, body~     composition, metabolic status.~   "
31660|NCT02642692|"~     The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone~     autograft versus hamstring autograft ACL reconstruction in soccer players.~   "
31661|NCT02642679|"~     The purpose of this single center, prospective case series is to evaluate the effective~     management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based~     dressing).~   "
31662|NCT02642666|"~     This pilot project will evaluate yoga as an intervention to improve attention and reduce~     challenging behaviors such as hyperactivity and impulsivity, rated by parent and teachers,~     in preschool age children with or at risk for attention-deficit hyperactivity disorder~     (ADHD). At Risk for ADHD will be defined as four or more hyperactive/impulsive and/or~     inattentive symptoms on the ADHD Rating Scale IV-Preschool Version as rated by parents or~     teachers. Using a randomized wait-list controlled experimental design, the investigators~     will explore the efficacy of practicing yoga for 6 weeks on behavioral symptoms, attentional~     control using a computer based tasks of attention, and heart rate variability (HRV), which~     is a measure of self-regulatory capacity. The investigators hypothesize that practicing yoga~     for six weeks of will improve ADHD and other behavioral symptoms based on parent and teacher~     rating scales, which will correlate with improvements in scores on the computer based task~     of attention as well as with improvements in HRV.~   "
31663|NCT02642653|"~     The purpose of the study is to test the efficacy of a 20 week multi-modal treatment~     comprised of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI)~     in children with FXS. Children will be randomized to drug or placebo in a double-blind~     design with all participating in the PILI. The primary endpoint will be to measure~     improvements in spoken language and behavior among lovastatin-treated than placebo treated~     participants.~   "
31664|NCT02642640|"~     This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose~     regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.~   "
31670|NCT02642562|"~     This study will address whether the additional use of Intravenous (IV) iron on top of~     standard care will improve the outlook for patients with heart failure and iron deficiency.~     One group of participants will receive treatment with iron injections and the other group~     will not receive any iron injections.~   "
31671|NCT02642549|"~     Girls for Health (G4H) will promote the economic empowerment, agency, and voice of rural~     adolescent girls by supporting their transition from secondary school to tertiary training~     in midwifery, medicine, nursing and other health careers, and in so doing, will address the~     acute shortage of female health workers in rural Northern Nigeria. G4H will integrate proven~     girls' education strategies with innovative vocational interventions to build 1350 girls'~     career aspirations and academic achievement and will significantly increase the number of~     rural girls entering health training institutions (HTI) in four northern states. The program~     will include: 1) a bridge program offering accelerated academic instruction in science, math~     and English; 2) vocational counseling and practicums at local health facilities; 3) safe~     spaces to enhance critical life skills; 4) four month science immersion courses for girls~     accepted for admission to a health training institution; and 5) HTI capacity building to~     cultivate a rural female-friendly learning environment. G4H will work towards sustainability~     from the start by using existing secondary school and HTI infrastructure, and feeding into~     government rural health worker employment schemes.~      G4H will be evaluated using a rigorous cluster randomized controlled trial design,~     randomizing at the school level to assess its impact on key outcomes of interest that~     include rural girls' secondary school graduation and subsequent HTI enrollment, retention~     and completion, as well as delayed marriage and improved agency and voice. Process~     monitoring and costing analysis will be conducted to support quality implementation and~     dissemination efforts. The design will ensure that high quality evidence is available to~     guide the field regarding the effectiveness and costing of in-school bridge programming in~     broadening rural girls' participation in education and career opportunities in the context~     of low resource settings characterized by low rates of female participation in education and~     income generation.~   "
31672|NCT02642536|"~     The purpose of this study is to find out which of two programs, MH MOVE! or the enhanced~     usual care MOVE! program is most effective in improving participation in and completion of~     MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE!~     provides the standard MOVE! weight management program plus a workbook containing education~     for management of depression, anxiety and PTSD symptoms to be used during 10 phone based~     clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight~     management program plus a workbook containing education for management of depression,~     anxiety and PTSD symptoms but not phone calls are provided.~   "
31673|NCT02642523|"~     The investigators are examining:~        1. the relationships of insulin levels and natriuretic peptide hormone levels, and~        2. the effects of administering an infusion of natriuretic peptide hormone on the~          breakdown of fat~      in healthy lean and otherwise healthy obese individuals.~   "
31674|NCT02642510|"~     The purpose of this study is to evaluate the impact of a structured, DVD educational~     intervention about what to expect during inpatient treatment of a newly diagnosed cancer.~     The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and~     their family members. Outcome variables will be the patient and family member's satisfaction~     with inpatient teaching and anxiety about inpatient treatment.~   "
31675|NCT02642497|"~     This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation~     into the wound of total thyroidectomy compared to placebo,and to systemic ketamine~     administration (I.M. injection of the same dose) with respect to postoperative VAS, first~     request of analgesia, total opioid consumption, and with respect to possible side effects.~   "
31676|NCT02642484|"~     -  Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly~          effective drug.~        -  Quinine was suggested for treatment of patients with muscle cramps in patients with~          liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are~          serious side effects.~   "
31677|NCT02642471|"~     The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been~     well studied. However, there were no randomized controlled study on comparing the long-term~     outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform~     a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy could~     be replaced by sentinel lymph node biopsy in surgical treatment for patients with~     early-stage cervical cancer.~   "
31678|NCT02642458|"~     PerFECT is a non-interventional, multicenter study designed to document representative~     epidemiological data under real life conditions of patients with the diagnosis of metastatic~     or locally recurrent, unresectable HER2-positive breast cancer, who are treated either with~     pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel as first line~     therapy, administered intravenously in a three weekly frequency, thereby reflecting the~     treatment regimens established in the CLEOPATRA study.~   "
31679|NCT02642445|"~     Renal sympathetic denervation from the intima of renal arteries has become an important~     method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly~     located in the adventitia, and there is no report about renal sympathetic denervation from~     the renal adventitia. Primary aldosteronism is an important factor of secondary~     hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of~     plasma aldosterone, in some patients blood pressure control is still not desirable after~     resection of tumor aldosterone. This study intends to conduct renal sympathetic denervation~     ablation from the adventitia to observe its efficacy and safety on blood pressure of~     patients with primary aldosterone.~   "
31680|NCT02642432|"~     The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following~     12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5~     or 6 infection and compensated cirrhosis.~   "
31694|NCT02642250|"~     Revival of significance and the emergent market of herbal medicinal products necessitate~     strong commitment by the stakeholders to safeguard the end users. The variability in the~     concentrations of constituents of plant material, coupled with the variety of extraction~     techniques and processing steps used by different manufacturers, results in distinct~     inconsistency in the quality of herbal products. The present study will be directed to a~     polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been~     used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is~     the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa,~     Querecus infectoria and Helicteres isora. The current study would target the chemical~     assessment, pharmacological and comparative clinical evaluation of Entoban to assure its~     safety and efficacy.~   "
33891|NCT02613455|"~     The purpose of this study is to prospectively compare the pain and functional outcomes of~     patients with chronic lateral epicondylitis treated with either intratendinous~     corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).~   "
31681|NCT02642419|"~     In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD),~     antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis~     and cardiovascular events in combination with anticoagulant drugs. Based on the observations~     that the incidence of hemorrhagic complications increased when an antiplatelet drug was~     administered in combination with vitamin K antagonist (VKA), the guidelines for~     antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets~     therapy) should be used in AF-complicated CAD patients for as short a time as possible~     following single anti-platelet and VKA, and that monotherapy with VKA should be started from~     one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the~     guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage~     to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no~     clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug~     therapy with a NOACs in stable CAD patients one year or more after PCI.~      AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a~     rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the~     evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that~     rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction~     (MI).~   "
31682|NCT02642406|"~     Despite treatment improvements in breast cancer, a large number of patients still progress~     to the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable~     prognosis. Not only efficacy, but also quality of life are in the focus when planning a~     therapy or therapy sequence for metastatic breast cancer patients. Therapy options include~     anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One~     of the most effective chemotherapies in the adjuadjuvant and metastatic setting is~     paclitaxel. However drug handling and its side effects can compromise patients quality of~     life and can have an impact on the pharmacokinetics of the drug.~      In metastatic breast cancer patients increasing therapy efficacy and reduction of side~     effect frequency are considered to be advancements of therapy. One of these advancements is~     the development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane),~     which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is~     approved for the treatment of metastatic breast cancer after a failure of first-line therapy~     and when antracyclines are not indicated.~      The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and~     the frequency and perception of side effects.~      As a non-interventional study, the SERAPHINA Study will assess the patient characteristics~     and describe the patient cohort, in which nab-Paclitaxel is given. This includes age~     distribution, molecular epidemiological characteristics and characteristics documented by~     the patients themselves.~   "
31683|NCT02642393|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine~     whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0~     mg/dL) over 2 years slows clinical decline in early PD.~      Clinical decline will be assessed as change in the primary outcome variable of the Movement~     Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale~     comprising patient- and clinician-reported outcomes.~   "
31684|NCT02642380|"~     The project was organized by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of different cycles of high-dose dexamethasone for the~     treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).~   "
31685|NCT02642367|"~     The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by~     some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious~     complications. We compared the intubation time and success rate whether or not use of stylet~     for endotracheal intubation with McGrath videolaryngoscope.~   "
31686|NCT02642354|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
31687|NCT02642341|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
31688|NCT02642328|"~     Traditionally, strength training and power is the main objective of providing only muscle~     conditioning, without possible gains on the VO2Max, however, not for aerobic performance.~   "
31689|NCT02642315|"~     Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main~     complication during long-term DA treatment of RLS. This study aims to examine effect of~     Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.~   "
31690|NCT02642302|"~     Based on studies of high intensity interval training (HIIT) in the literature, higher gains~     in VO2max and performance are obtained in short periods of training time. However, different~     designs training configurations, for example, changing the time interval, could influence~     such gains on VO2max and aerobic performance. The aim of the study was to observe the~     possible influences of diferetes types of rest intervals in high intensity interval exercise~     protocol on VO2max, and the aerobic and anaerobic performances in 12 weeks of training.~   "
31691|NCT02642289|"~     This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.~   "
31692|NCT02642276|"~     In this controlled trial, patients with peripheral arterial disease will be randomized to~     either maximal walking, submaximal walking, or usual care groups.~   "
31693|NCT02642263|"~     Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean~     delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its~     parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In~     a double-blind, prospective design patients will be either attributed to the oxytocin or the~     carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the~     cesarean delivery scar. This will be performed with a von Frey hair, resulting in a~     unpleasant feeling in the area of hyperalgesia.~   "
31695|NCT02642237|"~     To evaluate the bacterial-viral interactions between LPS and Fluenz as a model for sepsis~     (bacterial) and Influenza (viral) infections which are common and associated with high~     mortality rates in the ICU. To understand these interactions is important for the~     development of preventive and therapeutic interventions.~   "
31698|NCT02642198|"~     This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP)~     measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe~     Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3~     years old patient population. The study is defined according to the International Standard~     ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers — Part 2: Clinical investigation~     of automated measurement type.~   "
31699|NCT02642185|"~     This study aims to prove that a strategy of first line local ablation of colorectal liver~     metastases with microwaves is not inferior to liver resections in terms of survival rates at~     three years with secondary endpoints being survival at five and ten years, interventional~     complication rates, length of stay, ablation precision measurements, need for further~     interventions and health-economic analysis.~      A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm~     in size will be followed and compared with propensity scored matched controls from the~     Swedish liver surgery registry - Sweliv.~      The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in~     Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.~   "
31700|NCT02642172|"~     The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS~     75/25) is effective in treating patients with non-alcoholic liver disease.~   "
31701|NCT02642159|"~     Primary Objective:~      To demonstrate the superiority of alirocumab in comparison with usual care in the reduction~     of non-high-density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes and~     mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with~     maximally tolerated statin therapy.~      Secondary Objectives:~        -  To demonstrate whether alirocumab is superior in comparison with usual care in its~          effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C),~          apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]),~          high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich~          lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III),~          lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle~          size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density~          lipoprotein [IDL] particle number).~        -  To assess changes in diabetes parameters with alirocumab vs. usual care treatment.~        -  To demonstrate the safety and tolerability of alirocumab.~        -  To evaluate treatment acceptance of alirocumab.~        -  To evaluate PCSK9 concentrations and antibody development.~        -  To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other~          lipid parameters (subgroup analysis).~   "
31702|NCT02642146|"~     This study evaluates the efficacy and safety of routine medical treatments of digital ulcers~     in patients with systemic sclerosis in a prospective cohort study.~   "
31703|NCT02642133|"~     This study is an observational study to determine outcomes of surgical release of tongue-tie~     and lip-tie in babies who are experiencing difficulty with breastfeeding.~   "
31704|NCT02642120|"~     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage~     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate~     pain.~   "
31705|NCT02642107|"~     Currently, most protocols of nasopharyngeal carcinoma(NPC) of various research bodies such~     as the Radiation Therapy Oncology Group require routine elective irradiation to the~     retropharyngeal area and to levels II-V, and also to the supraclavicular lymph nodal areas~     regardless of the status of nodal metastasis. Previous studies had confirmed that the~     pattern of cervical lymph node metastasis in NPC followed an orderly manner. Retropharyngeal~     lymph nodes (RLNs) and Level II LNs were the most commonly involved, followed by Level III~     and Level V LNs, Level IV LNs, and SCF LNs, and the incidence of LN skip metastasis is rare,~     ranging from 0.5% to 7.9%. It was rare for NPC patients without neck lymph node metastases~     to experience neck failure after elective irradiation to levels II, III and VA. It also~     confirmed that with unilateral LN metastases of higher-level LNs usually spread down~     ipsilateral LNs.Thus, the investigators conduct the non-inferior randomized trial to~     determine the value of elective neck irradiation in NPC with N0-N1.~   "
31706|NCT02642094|"~     To examine whether rapamycin can reduce malignant markers and aberrant mammary~     stem/progenitor cells (MaSCs) number in surgical specimens~   "
31707|NCT02642081|"~     The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs~     (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In~     addition, the investigators would like to assess the risk of admission for acute~     decompensated heart failure following exposure to NSAIDs within 30 days.~   "
31708|NCT02642068|"~     We anticipate that drug-naïve ADHD probands, particularly those with DAT1 or SLC6A2 gene~     variants may have higher level of altered microstructural integrity of frontostriatal (FS),~     frontoparietal (FP), other hypothesized fiber tracts and decreased brain activity of FS, FP,~     and other circuits, deficits in ERP, and impaired EF, SA, IIA and VM than probands without~     DAT1 or SLC6A2 gene variants or adult neurotypical. The alterations in the structural and~     functional connectivity, neurophysiological and neuropsychological functioning would be~     observed in the unaffected siblings as compared to neurotypical. The unaffected siblings~     will be in the intermediate position between drug-naïve adult ADHD probands and~     neurotypical. The genetic dosage is anticipated to pose the strongest effects on the~     cortical thickness, brain volume, gyrification and microstructural property of white matter,~     followed by neurophysiology, functional connectivity, and neuropsychological function with~     the least effect.~      In terms of longitudinal follow-up part, we also anticipated despite increasing thinning of~     cortical thickness, microstructural integrity of several targets fiber tracts, and brain~     activity of target brain regions and improving performance in EF, SA, IIV, VM from childhood~     to late adolescence and young adulthood in the neurotypical group, the slopes of~     developmental trajectories of these neuroimaging and neuropsychological function are lower~     in the ADHD group.~   "
31709|NCT02642055|"~     This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in~     improving attention skills in children. Half of participants will receive the Neuro+~     intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for~     the same period. We expect those receiving the Neuro+ intervention to see significant~     improvements in ADHD symptoms relative to the TAU controls.~   "
33910|NCT02613208|"~     The purpose of this study is to identify a powerful and easy predictive/prognostic marker to~     drive patients under bevacizumab.~   "
31710|NCT02642042|"~     This phase II trial studies how well trametinib and docetaxel work in treating patients with~     stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back.~     Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving trametinib with docetaxel may work better in~     treating non-small cell lung cancer.~   "
31711|NCT02642029|"~     The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the~     impact of modulating cerebellar activity on time perception, executive function, and mood~     and psychotic symptoms in psychosis patients (i.e., schizophrenia, schizoaffective disorder,~     and bipolar disorder with psychotic features) and healthy control participants. The~     investigators hypothesize that abnormally reduced activity in the cerebellum contributes to~     the abnormalities in patients, that cerebellum-mediated disruptions in time perception may~     partially underlie executive dysfunction and symptoms, and that cerebellar stimulation will~     normalize disease-relevant outcome measures.~   "
31712|NCT02642016|"~     This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose~     (MTD) and/or recommended Phase 2 dose, and the safety profile of KTN0158 in patients with~     KIT-positive advanced solid malignancies refractory to standard therapy or for which no~     standard therapy exists.~   "
31713|NCT02642003|"~     Background and Aims: Liver transplantation is the only curative treatment modality for~     decompensated cirrhosis and is limited by donor organ availability and financial resources;~     thus many patients die while awaiting liver transplant. Granulocyte colony stimulating~     factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has~     been shown to benefit patients with liver disease. The investigators evaluated the efficacy~     of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.~      Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies~     were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical~     therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At~     the end of 6 months their survival were compared.~   "
31714|NCT02641990|"~     A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the~     effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora®~     (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal~     female subjects.~   "
31715|NCT02641977|"~     Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline~     treatment with Methotrexate.~   "
31716|NCT02641964|"~     Try to collect about 350 cases of acute necrotizing pancreatitis at the First Affiliated~     Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military~     Command. Then the investigators studied the incidence and the risk factors of ARDS in~     patients with acute necrotizing pancreatitis.~   "
31717|NCT02641951|"~     Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve,~     the lateral cutaneous branch of the second intercostal nerve that is often resected at~     mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral~     cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A~     second version of the pectoral nerve block is described, called ''modified Pecs block'' or~     Pecs block type II.~      This novel approach aims to block at least the pectoral nerves, the intercostobrachial,~     intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to~     provide complete analgesia during breast surgery~   "
31718|NCT02641938|"~     To investigate the renal protective effect of dexmedetomidine in patients undergoing~     cytoreduction and hyperthermic intraperitoneal chemotherapy~   "
31719|NCT02641925|"~     Many features of the metabolic syndrome are associated with insulin resistance. And,~     metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the~     investigators hypothesized that visceral fat removal (omentectomy) can make favorable~     results for the insulin resistance and metabolic syndrome. As the omentectomy is optional~     procedure during a surgery for early gastric cancer, the investigators will divide patients~     randomly into two groups, total omentectomy group and omentum preserving group.~   "
31720|NCT02641912|"~     This will be a single center, 7-day, examiner blind, two treatment-arm, randomized,~     stratified (Sjogren's Syndrome status [Y/N]), parallel group study conducted in participants~     experiencing dry mouth symptoms. This study is designed to investigate the effect of an~     experimental mouthwash formulation in providing relief of dry mouth symptoms.~   "
31721|NCT02641899|"~     A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of~     ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly~     Studied DDI Probe Compounds.~   "
31722|NCT02641886|"~     The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua~     Tan granules is effective in the treatment of cognitive impairment after acute cerebral~     infarction .~   "
31723|NCT02641873|"~     This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI +~     Bavacizumab. This study population is adult Japanese patients with metastatic colorectal~     cancers in FOLFIRI + Bevacizumab combination therapy.~   "
31724|NCT02641860|"~     Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor~     Cells Therapy for Knee Osteoarthritis.~   "
31725|NCT02641847|"~     The purpose of this study is to compare the efficacy and safety between docetaxel combined~     with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with~     cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel~     for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated~     signature and validation the efficacy of the signature.~   "
31726|NCT02641834|"~     The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet~     would benefit the cardiovascular risk profile of the participants, compared with a~     Mediterranean diet.~   "
31727|NCT02641821|"~     This is a multi-center, open-label, observational study. The aim of this study is to~     evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with~     mild-to-moderate hypertension.~   "
33911|NCT02613195|"~     The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve~     the quality of aging grafts in liver/kidney transplantation.~   "
31728|NCT02641808|"~     Follicular aspiration as well as follicular flushing are standardized techniques and have~     been practiced in polyfollicular IVF (in vitro fertilization) therapy for years.~     Monofollicular IVF therapy is a standard technique as well. IVF can be done in natural~     cycles or with a minimal stimulation with clomifen citrate to achieve a monofollicular~     response. Our study aims to compare follicular aspiration and follicular flushing in~     monofollicular stimulation. First the investigators want to answer the question whether~     flushing is beneficial for the oocyte yield. In case of a positive result the investigators~     want to establish a recommendation about the optimal number of flushings taking into account~     the duration of the procedure and the pain during manipulation.~   "
31729|NCT02641795|"~     A first in man clinical trial to asses the the use of am image guided robotic system to~     safely and effectively create a minimally invasive access tunnel to the middle ear cavity to~     allow access to the round window for cochlear implant electrode insertion.~   "
31730|NCT02641782|"~     Although the five year survival rate of children with high risk neuroblastoma have increased~     over the last three decades from 4 to 44 % (1), neuroblastoma is the second most frequent~     cause for cancer related death in childhood (11 %). Most patients show good initial response~     rates (complete (CR) and partial remission (PR) rate 95 %), but 55 % experience a largely~     treatment-resistant tumor progression.~      Recently, a breakthrough with immunotherapy was reported by US investigators from the~     Children's Oncology Group (2) using the anti-ganglioside D2 (GD2) monoclonal antibody~     ch14.18 for tumor cell destruction and granulocyte macrophage-colony stimulating factor~     (GM-CSF) plus interleukin 2 (IL-2) for immunostimulation. This immune therapy resulted in an~     increase of 20 % Event free survival (EFS) at 2 year from randomization. However, this was~     associated with a high toxicity rate (pain, capillary leak syndrome).~      The proposed trial compares the Childrens' Oncology Group (COG) standard of care arm~     (anti-GD2 + GM-CSF + IL-2 i.v. + retinoic acid oral) with an experimental arm (anti-GD2 +~     GM-CSF + IL-2 s.c. + retinoic acid oral) designed to reduce toxicity.~      The potential benefit from this trial consists of the confirmation that the American trial~     design is feasible in an independent set of patients with different preceding therapy, at a~     different time point regarding to immune reconstitution after autologous stem cell~     transplantation (ASCT), the feasibility of a newly designed immunotherapy (which is~     hopefully less toxic) and the investigation of immune response parameters. This pilot study~     is the prerequisite for a consecutive randomized clinical trial comparing two~     immunotherapeutic approaches in a larger set of patients.~   "
31731|NCT02641769|"~     This is an open label, single arm, single center investigation to assess the safety and~     efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal~     stem cells injected into the seminiferous tubules and testis, through a 12 week follow-up~     period. The investigators' selected model of research is based on maximizing the efficiency~     of the approach by choosing an autologous pattern which preserves the genetic make-up of an~     individual that is vital in infertility conditions. Additionally the approach involves~     injecting a combination of different but purified cell types which all aid in the retrieval~     of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this~     study are defined in general improvements in infertile patients in regards of testicular~     morphology, sexual function, semen quality, development of primary or secondary~     spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or~     semen.~   "
31732|NCT02641756|"~     The main goal of this study is to identify and characterise the anatomical component of the~     replication competent HIV-1 (Human Immunodeficiency Virus-1) reservoir.~      The investigators hypothesize that the clinically relevant HIV-1 reservoir is hiding in~     various but specific anatomic compartments and is able to rebound when therapy is stopped.~      This reservoir is probably smaller than the HIV-1 reservoir hiding in the blood but could be~     more transcriptional active because of its specific environment, possibly influenced by~     lower concentrations of the antiretroviral therapy.~      The current proposal will, for the first time, identify the source of the viral reservoir by~     phylogenetically backtracking the viral genome of the rebounding virus to the sequences of~     viral DNA (DeoxyriboNucleic Acid) in different anatomical compartments. The subsequent~     characterization of the viral reservoir markers (size, integration sites, methylation~     profile, stimulation and inhibition assays) will enable us to understand how this viral~     rebound occurred.~   "
31733|NCT02641743|"~     A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate~     (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve~     glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired~     glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on~     postprandial glycemic responses.~   "
31734|NCT02641730|"~     The purpose of this study is to evaluate the efficacy and safety of guselkumab for the~     treatment of participants with palmoplantar pustulosis.~   "
31735|NCT02641717|"~     Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and~     white blood cells per high-power field in self-collected vaginal specimens, compared to~     clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan~     Health sexually transmitted disease clinic.~      Research Design/Plan: Prospective, non-randomized, non-blinded trial~      Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg~     abnormal discharge, odor and/or itching). Calculate concordance between clinician- and~     patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity,~     specificity, positive predictive value and negative predictive value of the~     patient-collected wet mount, using the clinician-collected specimens as the gold standard.~      Clinical Relevance: A wet mount, or microscopic examination, is commonly used to diagnose~     trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial~     vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests~     for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little~     information about patient-collected wet mounts exists in the literature. Self-collection by~     women before being seen by a clinician can increase the speed and efficiency of the visit.~     The method is highly acceptable to women. In the investigators' clinic, women routinely~     collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be~     burdensome.~   "
34039|NCT02611531|"~     The purpose of this study is to evaluate the effectiveness of two different ways to teach~     subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge~     home from the hospital to determine durability of the education.~   "
31736|NCT02641704|"~     The aim of this project is a research-based evaluation of a multidisciplinary program~     focusing on moving citizens from unemployment and social security benefits to employment and~     education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the~     labor market or can get education through employment initiatives in the Job Centre in~     Sonderborg Municipality because of complex health-related troubles.~      The project is designed to include a prospective observational study and a qualitative study~     using questionnaires, observations, interviews and informations about employment from the~     Sonderborg Municipality.~   "
31737|NCT02641691|"~     The purpose of this research study is to look at how tumors responds to a short course of~     radiation (5 days) followed by 4 cycles of chemotherapy. The standard treatment for people~     with stage I rectal cancer is complete surgical removal of the tumor and associated area,~     which often means the creation of a permanent ostomy. Recent research has shown that the use~     of an organ preservation strategy has shown benefits in people with more advanced rectal~     cancers, and so the investigators propose to use a similar treatment strategy in this study~     to see if non-operative or less drastic operative therapy (and potentially avoiding a~     permanent ostomy) is feasible.~   "
31738|NCT02641678|"~     Prospective mono-center diagnostic study determining potential discrepancies in identifying~     atrial fibrillation by intraindividually comparing different types of follow-up strategies:~        1. How many stroke patients with atrial fibrillation are missed by standard stroke unit~          24h- electrocardiography, and~        2. what is the effectiveness of the extended invasive and non-invasive ECG analysis tools~          to detect atrial fibrillation in stroke patients?~   "
31739|NCT02641665|"~     The level of four biomarkers will be measured in the patients' plasma after induction of~     anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these~     marker will then be correlated with early (30 days) and late (one year) patients' prognosis~     and with functional recovery (MLHFQ score).~   "
31740|NCT02641652|"~     There is currently no established treatment for paroxysmal hypertension, but selective~     serotonin reuptake inhibitors showed good effect in previous reports. This double-blind,~     placebo controlled, prospective multicenter clinical trial will assess the efficacy of~     sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136~     patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and~     distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg~     daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment~     on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated~     after 3 months. If proven effective, sertraline might become a standard treatment for this~     condition.~   "
31741|NCT02641639|"~     This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase~     2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC~     plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC).~     Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or~     fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC~     plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs.~     paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to~     subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study,~     consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study~     (Part 2). Both parts of the study will have similar overall design. Approximately 80~     subjects will be randomized into Part 1 and approximately 356 subjects will be randomized~     into Part 2.~   "
31742|NCT02641626|"~     Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital~     cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited.~     Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to~     randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred~     coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.~   "
31743|NCT02641613|"~     Patients will be randomized to one of two groups:~        1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of~          ultrasound;~        2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of~          ultrasound.~   "
31744|NCT02641600|"~     Patients with chronic venous disease causing pain or ache will be randomised into two~     groups, active stockings (18-21 mmHg) or placebo stockings~   "
31745|NCT02641587|"~     The overall goal of the study is to demonstrate reduction in the levels of biomarkers of~     exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) and to~     obtain safety information in healthy subjects using the Carbon Heated Tobacco Product 1.2~     (CHTP 1.2) as compared to smokers continuing smoking combustible cigarettes (CC) in a~     confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.~   "
31746|NCT02641574|"~     To examine the relation between complication in Repeated Cesarean Sections and Newborn~     Outcome compared to number of repeated cesarean section and reasonf or surgery and personal~     medical information to the mother~   "
31747|NCT02641561|"~     Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP.~     Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis.~     Despite this, no study to date has evaluated both of these measures for preventing post-ERCP~     pancreatitis. It is our hope to evaluate the combination of these two modalities for~     preventing post-ERCP pancreatitis compared with either modality alone.~   "
31748|NCT02641548|"~     This study evaluates the addition of using a sock of silicone to using a heel cream, in the~     treatment of heel fissures in people with diabetes, aiming at healing the fissures and~     preventing them from developing into ulcers. Half of the participants will use the silicone~     sock and a heel cream, the other half will use the cream only.~   "
31749|NCT02641535|"~     Israel ministry of defense is examining a new BC membrane protective garment of BLAUER~     company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The~     goal of this research is to perform a comparative experiment in order to evaluate the~     physiological strain induced by the new protective garment under exercise-heat stress~     conditions, compared to protective garment in current use.~   "
31750|NCT02641522|"~     The purpose of this study is to evaluate the effects of siltuximab on immune cell functions~     in patients with Type 1 diabetes (T1D).~   "
31751|NCT02641509|"~     Interval colon cancers are an important clinical issue. Literature dealing with technics and~     quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated~     polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing~     that 10% of these polyps were not completely resected. This fact was attributed to size and~     histology (the majority of non completely resected ones, were polyps of 10-20 mm and with~     serrated characteristics at the histology). In this study the investigators want to evaluate~     the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the~     margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI)~     could be useful in the definition of the margins of the lesion before polypectomy.~   "
31752|NCT02641496|"~     Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks~     for major health problems, including dementia, heart attack, and stroke. Obesity, a growing~     problem for Americans and Veterans alike, is the greatest risk factor for the development of~     OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high~     comorbidity of these risk factors in Veterans, OSA presents a significant health burden to~     Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of~     Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are~     non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment.~     The proposed research aims to facilitate adherence to CPAP treatment by testing a novel~     cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may~     represent an approach that could be applied to the rehabilitation of other chronic~     conditions with similar barriers to care.~   "
31753|NCT02641483|"~     The investigators are testing the effect of electrical stimulation of the rectum on colonic~     motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction,~     which includes slowed colonic motility, which means that stools take longer than normal to~     pass through the colon. This slowed movement may result in chronic constipation and~     difficulty emptying the bowels. Individuals typically (without or without caregiver~     assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic~     motility for a brief period to empty the bowels. The investigators hypothesize that~     electrically stimulating the rectum, instead of mechanically stretching it, will produce the~     same beneficial effect of improving colonic motility. Therefore, this study will compare the~     two methods. If electrical stimulation effectively improves colonic motility, then the~     investigator shall develop the approach as a therapeutic intervention in future studies.~   "
31754|NCT02641470|"~     Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from~     intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant~     is native to cool temperature regions of the Northern Hemisphere. Considering its~     antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a~     significant role in treating various ocular pathologies. The investigators performed a~     randomized, case-controlled study in healthy subjects and investigated the protective effect~     of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.~   "
31755|NCT02641457|"~     Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences~     between the two drugs. To determine and compare whether intraocular aflibercept and~     ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).~   "
31756|NCT02641444|"~     The purpose of this research study is to find out how the drugs Truvada®~     (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva®~     (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital~     tract. All of these drugs are very effective at reducing the number of HIV viruses in the~     blood, however it is unknown how the drugs move around inside tissues where HIV might be~     hiding. This study will determine specifically where in the tissue the drug and the HIV are~     located through the use of a new technology that takes creates a picture of the tissue. This~     information will help scientists determine the best way to make new drugs to target the~     hidden HIV in tissue.~   "
31757|NCT02641431|"~     This prospective study evaluates the methodology and results of epicardial mapping/ablation~     in a large series of consecutive selected BrS patients and to verify if RFA could normalize~     the consequences of a genetic disease.~   "
31758|NCT02641418|"~     Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the~     major arteries supplying the lower limbs and is associated with an increased risk of~     mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing~     intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the~     population >50 years and is associated with a substantial reduction in walking capacity,~     quality of life and diminished physical function. Supervised exercise programmes have been~     demonstrated to improve maximum walking distances and NICE recommends group-based supervised~     exercise for treating patients with IC. However, there is significant variability in the~     impact of treatment across studies and little agreement on the underlying mechanism whereby~     exercise increases functional outcomes. Potential mechanisms include skeletal muscle~     metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to~     better understand how exercise improves outcome and in whom, so as to better refine and~     target the treatment.~      The participation of patients with IC in exercise programmes is low. The investigators need~     to understand factors influencing participation so that we can improve the number of~     patients with IC benefiting from the programme~      The research consists of two workstreams:~      Workstream one~      Objective:~      Assess the extent to which patient baseline characteristics and candidate physiological~     mechanisms are associated with clinical improvement in IC patients participating in an~     exercise programme~      Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients~     will be invited to participate in a 12 week supervised exercise programme.~      Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately~     after the completion of the exercise programme and then three months after. Measurements~     include:~      Baseline characteristics that might predict outcome:~        -  Quality of life using the VascuQol questionnaire~        -  Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI),~          intermittent claudication distance (ICD), Maximum walking distance (MWD).~      Candidate physiological mechanisms~        -  Aerobic capacity (VO2 max & AT)~        -  Muscular strength and endurance~        -  Muscle morphology (including muscle thickness, pennation angle, fascicle length and~          elastography)~        -  Endothelial function (sheer stress response as measured by flow mediated dilation)~      Analysis: Regression analysis will be used to explain variation in patient maximum walking~     distance at 3 months. The regression will use 9 candidate measures of physiological response~     and 3 baseline measures to explore what mechanism and patient factors may be associated with~     clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect~     an additional increase in variability in MWD explained by each candidate measure of around~     5% at the a 0.05 significance level.~      This research will be used to identify which types of exercise may be most influential in~     improving outcome and in which patients.~      Workstream two~      Objective:~      Explore the reasons behind patients' participation, non-participation in, experience of and~     adherence to the exercise programme.~      Study Design: An interview study of patients with IC routinely referred for supervised~     exercise. Three groups of patients will be invited to participate. Those who:~        -  Choose not to participate in the exercise programme (Group A)~        -  Agree to participate in the exercise programme (Group B).~        -  Agree to participate but discontinue after at least one session (Group C).~      Semi-structured face-to-face interviews with 20 patients per group, interviews will be~     conducted using a topic guide to ensure consistency. The format will be flexible to allow~     participants to generate naturalistic data on what they consider as important and / or~     successful in terms of outcome. Data will be analysed thematically and managed using Nvivo~     software - the approach will be inductive and iterative.~      This research will be used to redesign the current exercise programme to improve~     participation and so the impact of exercise in patients with IC.~   "
31759|NCT02641405|"~     It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on~     Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation~     seems be useful in symptoms amelioration in several neurological disease. Few studies have~     been performed in Parkinson's disease. A total of 126 patients suffering from PD will be~     recruited in 6 italian neurological centers. The study will be a cross-over multicenter~     study with the randomization of the sequence. The patients will be randomly assigned to 2~     groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo.~     Gait analysis will be recorded in each patient at the beginning and at the end of the~     treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait~     analysis recording will be performed. Finally a last recording will be taken at the end of~     the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society -~     Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC~     (Activity Specific Balance Confidence Scale).~   "
31760|NCT02641392|"~     This is a Phase 3, double-blind, active treatment extension study to evaluate the long-term~     safety of GED-0301 over 208 weeks in subjects with Crohn's disease (CD) who previously~     participated in either of the following two Phase 3 GED-0301 studies:~        -  Study GED-0301-CD-002~        -  Study GED-0301-CD-003~   "
31761|NCT02641379|"~     This study will compare the efficacy and safety of 2 different treatment durations of~     peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on~     study treatment is 1-2 years, and the target sample size is greater than (>) 500~     individuals.~   "
31804|NCT02640820|"~     Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active~     pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in~     acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic~     melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will~     be evaluated for the treatment of common warts.~   "
31762|NCT02641366|"~     Deep Brain Stimulation (DBS) is an effective treatment option for individuals with~     debilitating tremors that do not respond to medical therapy. However, severe tremors,~     particularly those that develop after central nervous system insult or from multiple~     sclerosis, can be comprised of several underlying components that represent dysfunction~     within distinct brain circuits. Some of these dysfunctional brain circuits can be~     successfully treated with DBS while others respond poorly DBS therapy. For severe tremors,~     it can be very difficult to discriminate between the underlying components of a patient~     movement disorder and is exclusively dependent upon clinical expertise. Even with extensive~     clinical experience, it is difficult to reliably predict the results of DBS therapy for~     patients suffering from severe, debilitating tremor. In an attempt to gain more knowledge,~     an electromagnetic tracking system will be used which can precisely measure the position of~     a patient's upper extremity in space during routine neurologic examination. The goal is to~     use this tool to quantitatively identify various components of severe tremor, which can be~     discriminated based on oscillatory frequency and regularity of tremor amplitude. The purpose~     of this research study is to better understand the nature of complex, severe tremors by~     carefully measuring movement of the upper extremities with sensors during simple tasks. The~     goal is to break down complicated tremors into their components and then determine which~     components will respond to deep brain stimulation.~   "
31763|NCT02641353|"~     The purpose of this study is to assess how much of apremilast is found in the blood~     unchanged when administered as an oral suspension compared to when it is administered as a~     tablet formulation. The effect of food on apremilast oral suspension will also be evaluated.~     In addition, information on the safety and tolerability of apremilast will be obtained.~      CC-10004 (also known as apremilast or Otezla®) has been approved by the Food and Drug~     Administration (FDA) for the treatment of active psoriatic arthritis (PsA) and moderate to~     severe plaque psoriasis in adults. The liquid formulation of apremilast is an~     investigational drug being developed by Celgene Corporation to treat plaque psoriasis in~     children. An investigational drug is not approved by the U.S. Food and Drug Administration~     (FDA).~   "
31764|NCT02641340|"~     The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic~     relationship of multiple dose administration of fentanyl sublingual spray in opioid naive~     participants. The secondary objective is to determine the safety and tolerability of~     multiple dose administration of fentanyl sublingual spray in opioid naive subjects.~   "
31765|NCT02641327|"~     The study objective is to assess the accuracy of Earlysense contactless monitoring to detect~     changes in blood pressure vs. Gold reference method / devices including ambulatory blood~     pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who~     have arterial line as part of their standard clinical care.~   "
31766|NCT02641314|"~     Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already~     one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients~     experience further progression.~      Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying~     vasculature and the interactions between Tumor and immune cells. The toxicity is expected to~     be low due to the low (but continuous) dosing of drugs.~      The study investigates the tolerance and the efficacy of a new combination of five drugs~     consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating~     immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic),~     etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic,~     anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are~     applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each~     of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have~     been used in children for other conditions. From those experiences low toxicities and a~     favorable Quality of life are expected.~   "
31767|NCT02641301|"~     The purpose of this study is to determine whether sustained release morphine~     pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ~     from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the~     Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After~     Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics~     parameters for immediate release morphine, probably due to an earlier absorption of the~     morphine, in agreement with the expected clinical effect of this formulation.~   "
31768|NCT02641288|"~     A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve~     gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed.~     Patients will be randomized in 2 groups: those patients undergoing intraperitoneal~     ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal~     irrigation with normal saline (Control Group - CG).~   "
31769|NCT02641275|"~     The relentless progressive process of muscular dystrophy requires extraordinary medical,~     physical, and emotional care with severe consequences for caring parents (increased stress~     and diminished social, psychological and physical well-being). Despite the obvious need of~     support for parents only few and weak data exist regarding efficiency and efficacy of~     specific interventions supporting parental resilience and coping strategies. The presenting~     study aims to fill this gap by evaluating the efficacy of a structured self-management~     training for parents of children with severe progressive muscular dystrophy compared to~     parents receiving treatment as usual (TAU). In addition, investigators measure established~     biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to~     monitor physiological changes with assumed significance for parental health.~   "
31770|NCT02641262|"~     ST-segment elevation myocardial infarction (STEMI) remains among the most acute and critical~     diseases, with primary percutaneous coronary intervention (pPCI) and thrombolysis as~     mainstay reperfusion treatments. Real-world implementation of current guidelines for STEMI~     management has been assessed in developed countries and large Chinese cities. However, until~     now, there has been no registry on patients with STEMI in Henan, the most populated (about~     100 million) and predominantly rural (66%) province in central China.~      This registry is aimed to assess management practices, time delays, outcomes and reasons for~     not receiving reperfusion therapy in consecutive STEMI patients in reperfusion-capable~     hospitals, i.e., tertiary and secondary, in Henan province.~   "
34040|NCT02611518|"~     The purpose of this study is to look at how taking JNJ-54861911 every day will effect the~     amount of rosuvastatin or metformin in your blood after taking only a single dose of either~     one.~   "
31771|NCT02641249|"~     Purpose of Study: Apnea of Prematurity (AOP) is common, affecting the majority of infants~     born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH),~     which contributes to multiple pathologies, including retinopathy of prematurity (ROP),~     sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and~     neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning,~     positive pressure ventilation, and caffeine therapy, none of which is optimal. The objective~     is to support breathing in premature infants by using a simple, non-invasive vibratory~     device placed over limb proprioceptor fibers, an intervention using the principle that limb~     movements facilitate breathing.~      Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were~     enrolled 1 week after birth. Caffeine therapy was not a reason for exclusion. Small~     vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF~     sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2),~     and breathing pauses were continuously collected.~   "
31772|NCT02641236|"~     This research study is for participants who are undergoing allogeneic hematopoietic stem~     cell transplantation (HSCT) and are at risk for developing acute graft-versus-host disease~     (GVHD). GVHD is a complication of HSCT in which immune cells from the donor cause~     inflammation and injury to tissues and organs of the HSCT recipient. Vancomycin-polymyxin B~     (commonly called vancopoly) is an oral antibiotic that is given to people undergoing~     allogeneic HSCT as a preventive measure for acute GVHD. This research study is studying the~     effects of vancopoly on the microorganisms living in the intestine during and after stem~     cell transplantation.~   "
31773|NCT02641223|"~     For this study the investigators will conduct five-day trial periods for spinal cord~     stimulator (SCS) effectiveness—once a patient is deemed to be a possible SCS candidate, the~     trial leads are implanted and they are asked to return to clinic in five days to evaluate~     the effectiveness of the trial. The primary outcome for this study will be a comparison of~     daily energy expenditure (EE), in units of kcal/day, prior to and after the trial~     implantation of the SCS leads and external pulse generator. Patients will wear the~     accelerometer device twenty-four hours a day for five days prior to the trial lead~     implantation to obtain baseline values, have the trial leads implanted in the procedure~     clinic, then continue to wear the accelerometer for another five days. Baseline and post-SCS~     energy expenditure values will be compared. The secondary outcomes for this study will be~     steps taken, hours of sleep, and Oswestry Disability Index (ODI, as described in appendix 1)~     during the pre and post trial implantation periods. SCS itself is not a research procedure~     in this study, rather it is part of routine medical care for patients who would benefit from~     the procedure.~   "
31774|NCT02641210|"~     Periodontitis is an inflammatory/infectious disease of high prevalence in the population and~     which has been linked to several chronic inflammatory systemic diseases. However, few~     studies have evaluated the periodontal disease in the absence of other inflammatory~     conditions stimulate inflammatory markers as C-reactive protein (CRP), Interleukin - 6~     (IL-6) hepcidin and hemoglobin. The aim of this study was to evaluate the influence of~     nonsurgical periodontal therapy on the change of inflammatory markers and anemia in control~     subjects and patients with chronic periodontitis after three months.This interventional~     study included 67 individuals of both sexes, aged 30-65 years, without other diseases,~     except chronic periodontitis, with at least 20 teeth, selected from a total 125 individuals~     following the eligibility criteria. Periodontal clinical parameters (probing depth, bleeding~     on probing, clinical attachment level) and systemic, hematological as well as inflammatory~     markers CRP, IL-6 and hepcidin were compared before and after nonsurgical periodontal~     therapy by serum and plasma examination of control individuals and patients with chronic~     periodontitis.~   "
31775|NCT02641197|"~     The objective of this study is to define the repeatability and reproducibility of~     quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender~     (AD) methodology.~      Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using~     the same AD device and operator.~      Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but~     using different AD devices and operators.~   "
31776|NCT02641184|"~     The aim of this study is to investigate the potential novel risk factors for acute~     myocardial infarction. Predictors of poor outcomes will be also evaluated.~   "
31777|NCT02641171|"~     This study evaluates the use of exhaled air analysis as tool to monitor the disease activity~     in Crohn's Disease (CD). This study is a validation of the previous findings. In this study~     the participant will be asked to donate exhaled air, blood samples and fecal samples. The~     breath samples will be used to measure various volatile metabolites in breath. The breath~     air will be next used to validate the previous findings. The blood samples will be used to~     define the origin of volatile metabolites in breath. Finally, the potential of exhaled~     breath analysis as non-invasive marker of diseases activity will be compared to established~     fecal calprotectin.~   "
31778|NCT02641158|"~     Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation~     intervention in moving HIV/HCV co-infected substance users forward along the HCV care~     continuum (compared with a Control group).~      Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ~     between the two study groups over the 14-month follow-up period.~      Secondary Objectives:~      Component 1 (Long-term CTN 0049 follow-up):~      Using the CTN 0064 baseline data (self-report, medical record abstraction and biological~     data), the following CTN 0049 primary and secondary outcomes in participants who consented~     to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of~     the CTN 0049 interventions:~        1. HIV virological suppression~        2. HIV primary care visit attendance~        3. All-cause mortality~   "
31779|NCT02641145|"~     Cardiac amyloidosis is a major cause of early treatment-related death and poor overall~     survival in individuals with systemic light chain amyloidosis. This project will develop a~     novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The~     long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order~     to guide the development of novel life-saving treatments.~   "
31780|NCT02641132|"~     To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC)~     0.02%~   "
31781|NCT02641119|"~     This observational study evaluates the potential benefits, costs and clinical outcomes of~     albumin over saline and other non-saline fluids in patients receiving large volume~     resuscitation.~   "
31782|NCT02641106|"~     The three-month short-course treatment with isoniazid [H] and rifapentine [P] (3HP) recently~     recommended by the Centers for Disease Control and Prevention could dramatically increase~     the number of persons starting and completing treatment for latent tuberculosis infection~     (LTBI), but TB providers nationwide are hamstrung by the requirement that 3HP only be~     administered by directly observed therapy (DOT) in which patients are watched taking each~     medication dose in-person. We developed a novel mHealth application that allows patients to~     make and send videos of each medication dose ingested that are watched by healthcare~     providers via a HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video~     DOT [VDOT]). This study will determine whether monitoring patients with VDOT achieves higher~     treatment completion rates and greater patient acceptability at lower cost than clinic-based~     in-person DOT.~   "
31783|NCT02641093|"~     The purpose of this research study is to test the safety and the benefit of adding~     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of~     care treatment for head and neck cancer. The standard of care treatment will include surgery~     followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of~     care once a week for 6 weeks if the cancer is found to be high risk. High risk includes~     cancer that was not completely removed (positive margins) or cancer that has invaded through~     the outer lining of your lymph nodes.~   "
31784|NCT02641080|"~     For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone~     compared to using Aspirin along with a mobile compression device provide equivocal results~     for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint~     arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and~     knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while~     continuing to prevent thromboembolic disease. The equivalency of using the mobile~     compression devices with aspirin compared to aspirin alone in patients undergoing total hip~     and knee arthroplasty will be evaluated. A previous study has shown that patient compliance~     with the pneumatic compression device is less than 80%.~   "
31785|NCT02641067|"~     This study will evaluate the effect of severe renal impairment on the pharmacokinetics of~     doravirine.~   "
31786|NCT02641054|"~     CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and~     antidyskinetic activity in a macaque model and has shown a significant effect on the~     UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while ON,~     as well as an increase of ON-time without dyskinesia or without troublesome dyskinesia in~     a previous phase 2a proof of concept study. This study will confirm the efficacy of~     CVXL-0107 in combination with optimal dose of levodopa on motor symptoms of Parkinson's~     disease (PD) .~   "
31787|NCT02641041|"~     The primary objective of this study is to assess the safety and tolerability of a single~     dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The~     secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of~     BIIB033 administered as single and multiple doses in healthy adult Japanese participants and~     to assess the single-dose and multiple-dose immunogenicity of BIIB033.~   "
31788|NCT02641028|"~     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a~     Human Laboratory Model of Smoking Behavior.~   "
31789|NCT02641015|"~     A retrospective observational study to assess the clinical management and outcomes of~     hospitalised patients with complicated urinary tract infection in countries with high~     prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)~   "
31790|NCT02641002|"~     Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion~     (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects~     with relapsed and/or primary refractory AML and high-risk MDS. The study will explore~     escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by~     dose expansion in Part B.~      The primary objective is to determine the safety and tolerability of CC-90002 and also to~     define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended~     Phase 2 dose (RP2D) of CC-90002.~   "
31791|NCT02640989|"~     The purpose of this study is to assess the safety and immunogenicity of three seasonal~     trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac~     Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using~     imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy~     servicemen.~   "
31792|NCT02640976|"~     The aim of this study is to assess the role of AMH in prediction of poor ovarian response as~     well as the relation between ESR2 (+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G,~     rs6165) and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs and the poor response in Egyptian~     women undergoing IVF procedure. Discovering the genetic variants associated with ovarian~     response is an important step towards individualized pharmacogenetic protocols of ovarian~     stimulation.~   "
31793|NCT02640963|"~     This study is a pilot study (feasibility and acceptability study), which will compare~     feasibility and efficacy outcomes between a 12-week Exercise Program and control group in~     RAC residents.~   "
31794|NCT02640950|"~     Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based~     treatment for major depressive disorder. While there is a growing anecdotal database~     supporting its use in bipolar depression the investigators propose to collect open label~     efficacy and safety data in a small population of patients with clinically verified bipolar~     disorder.~   "
31805|NCT02640807|"~     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing~     frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte~     counts in sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis~     patients).~      A parallel study will be performed in France to allow a common statistical analysis of the~     primary end points and analysis for the enrolled patient population.~   "
31806|NCT02640794|"~     The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with~     aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the~     prevention of major ischemic events (MI, ischemic stroke) or death without increasing the~     risk of major bleeding events.~   "
31993|NCT02638337|"~     The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once~     daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to~     menopause in women with moderate to severe vaginal dryness as the most bothersome symptom~     (MBS) of VVA.~   "
31795|NCT02640937|"~     This was a prospective study performed between November 2011 and September 2013. Patients~     with a confirmed S. epidermidis infection after fracture fixation or prosthetic joint~     infection were included. Exclusion criteria included infections involving external fixation~     pins, infections without any implanted hardware and culture positive patients not displaying~     any clinical sign of infection. The following surgical parameters were documented: affected~     bone or joint; type of implant; time between implantation of the device and onset of~     symptoms. Personal characteristics and patients`health status were also documented. Any~     revision surgeries involving the site of interest and all isolated pathogens were recorded~     throughout the course of treatment and follow-up.~      A follow up examination was performed an average of 26 months after discharge. Primary~     outcome at follow up was cure. Cure was define by the authors as: missing local (at site of~     interest) or systemic signs of infection, terminated surgical and systemic therapy and~     restoration of joint or limb function.~      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken~     from the interface between implant and affected bone. Identification and antibiotic~     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined~     according to the definitions of the European Committee of Antimicrobial Susceptibility~     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays~     according to protocol of Stepanovic et al.(see references).~   "
31796|NCT02640924|"~     Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic~     viral hepatitis is common. Patients with HCC typically have impaired liver function because~     of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of~     them are appropriate candidates for surgery. The 5-year overall survival for patients~     treated by surgery is approximately 30%-70%. For those not treated with surgery, liver~     function affected by an underlying liver disease has a strong influence on clinical~     outcomes, and complicates treatment strategies further than for other tumors. Maximal~     preservation of normal liver volume and function is an important consideration in the choice~     of treatment.~      Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several~     retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and~     nearly no major complications. The investigators also retrospectively reviewed 75 index~     tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation~     with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and~     31 December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated~     1-, 2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%,~     81% and 89%, 83%, 67%, respectively.~      Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to~     larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton~     therapy was better than radiofrequency ablation, this prospective trial is aimed to compare~     the effects of these two modalities in 3-7 cm HCC patients who are not candidates for~     surgery or refuse surgery. This prospective study has high possibility to confirm the role~     of proton beam in HCC.~      Along with the clinical trial, the investigators will also use next generation sequencing~     (NGS) to exam gene expression profile of tumor samples and find out candidate genes related~     to local control, intrahepatic control (treatment out-field control in liver), regional~     lymph node relapse, distant metastasis, and treatment response in HCC.~   "
31797|NCT02640911|"~     This multi-centre study will evaluate the safety and related factors study of atypical~     antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical~     antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone,~     paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort,~     multi-center observational clinical study. The main purpose is to evaluate the safety. And~     the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy~     evaluations include symptoms, social function, recurrence rate and hospitalization. This~     study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases.~      Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical~     examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/~     blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead~     electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function~     evaluation, medication and other subjective feelings. The second indexes include scales of~     Positive and Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness~     Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social~     Performance Scale(PSP), the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug~     consolidation, medical-related expenses, income, drug plasma concentration and genetic~     information.~   "
31798|NCT02640898|"~     Although the intergroup 0116 trial was the first to demonstrate that adjuvant~     chemoradiotherapy offers a significant survival benefit in completely resected gastric~     cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.~   "
31799|NCT02640885|"~     Post-partum haemorrhage due to placenta previa is usually from the placental bed at the~     lower uterine segment and it occurs after the placenta separation. Although, nowadays the~     obstetrician can diagnose placenta previa before delivery, it is still one of the important~     causes of maternal mortality . Hysterectomy can be the only effective action to take,~     although it carries many morbidities for the women especially those with low parity.~      Uterine packing considers as a line of treatment before performing surgical procedures in~     postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid~     laparotomy and save uterus.~      Nowadays, the use of intrauterine balloons have been developed and become effective for the~     control of placental site bleeding not responding to medical treatment. The 2-way Foley's~     Cather has many advantages over the gauze packing; First, it allows drainage of blood so no~     occult bleeding could be accumulated inside the uterus as in uterine gauze, second the~     removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way~     Foley's Cather could be gradually as a test of its effectiveness before complete removal .~   "
31800|NCT02640872|"~     This study is a hospital-based, prospective cohort study to elucidate the predictive factors~     for chronic disease of elderly persons aged 60 years and older.~   "
31801|NCT02640859|"~     A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic~     and other diseases~   "
31802|NCT02640846|"~     The aim of this study is to compare the effects of milrinone(Corotrope) and~     levosimendan(Simdax) on septic cardiomyopathy using pulmonary artery catheter, conventional~     and strain echocardiography.~   "
31803|NCT02640833|"~     This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and~     determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in~     participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small~     lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not~     previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2~     portion of the study will preliminarily evaluate efficacy, and expand the toxicity~     evaluation.~   "
31807|NCT02640781|"~     Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal~     malignancies, but emergent surgical decompression is associated with high morbidity and~     mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an~     alternative to surgery and effectively decompress the colonic obstruction and allow for~     bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered~     stents and covered stents. Covered stents have the advantage of less frequent stent~     occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas~     uncovered stents are associated with less stent migration, although they appear to be more~     prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered~     combination covered stent was developed. In the present study, the investigators evaluated~     the efficacy and safety of the newly designed covered stent by comparing it with the~     uncovered stent in patients with malignant colorectal obstruction.~   "
31808|NCT02640768|"~     The prevalence of diabetes among inpatients in medical wards, surgery and intensive care~     units in Italy is approximatively 12-25%. The management of in hospital diabetes and~     hyperglycemia is complex and requires a specific training for physicians and nurses in~     non-specialist settings. The overall project aims at the implementation of a best practice~     model of care for hospitalized diabetic patients in non-specialist settings.~   "
31809|NCT02640755|"~     This Phase 1, open label, single centre, non-randomised study in patients with advanced~     solid malignancies consists of two parts:~        1. Single Dose Period - will characterise the absorption, metabolism, excretion and~          pharmacokinetics of a single oral dose of [14C]AZD2014 from the body~        2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour~          activity of multiple doses of AZD2014 when given as a monotherapy or given in~          combination with paclitaxel or fulvestrant.~   "
31810|NCT02640742|"~     This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency,~     and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult~     asthma patients.~   "
31811|NCT02640729|"~     This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual~     hallucinations in subjects with Lewy body dementia.~   "
31812|NCT02640716|"~     This study evaluates the efficacy and mechanism of internet-based cognitive training in~     patients with subcortical VCIND. Half of participants will receive multi-domain adaptive~     internet-based training program, while the other half will receive a fixed, primary~     difficulty level task.~   "
31813|NCT02640703|"~     Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show~     diurnal variations in vaccination response, due to circadian regulation of the immune~     system. The investigators plan to investigate whether preterm infants also show differences~     in hypoxia/bradycardia rate upon morning vs. evening vaccination.~      Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours~     after vaccination; parents also kept a sleep-diary. 24 hours after vaccination~     interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination~     response, pertussis- and haemophilus-titers are determined before vaccination and at 4~     months corrected age.~   "
31814|NCT02640690|"~     The proposed study will evaluate the effectiveness of a yoga intervention to treat~     posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia,~     and biological and physiological responses to trauma and PTSD in women Veterans who~     experienced military sexual trauma (MST). If effective, this yoga intervention could reduce~     PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic~     fight or flight stress response and the damage this stress response causes in the body,~     including heart disease and diabetes. This intervention could improve these women Veterans'~     quality of life and social functioning, for example, going to work and having satisfying~     relationships with family and friends. This study may support an innovative, complementary~     and alternative PTSD treatment for women Veterans who experienced MST. This new,~     evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines~     for this yoga intervention could be implemented nationally in the VA health care system.~   "
31815|NCT02640677|"~     4CMenB was approved by the Food and Drug Administration (FDA) in the United States in~     January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during~     pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may~     also occur - before the woman knows she is pregnant, for example. The objective of this~     study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about~     the health of women who have been vaccinated with 4CMenB within 30 days prior to their last~     menstrual period (LMP) or at any time during pregnancy, and the health of their infants.~     Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days~     prior to their last menstrual period or at any time during pregnancy are eligible to~     participate. A woman may self-enroll in the registry by calling the pregnancy registry~     telephone number directly or their healthcare provider (HCP) can, with their consent, enroll~     them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures~     and outcomes occurring within their network/health maintenance organization (HMO). The~     health of the woman and her infant will be followed up until the end of the pregnancy.~   "
31816|NCT02640664|"~     The purpose of this study is to evaluate the long term efficacy and safety of intravitreal~     ranibizumab compared with laser ablation therapy in patients who were treated for~     retinopathy of prematurity (ROP) in the core study CRFB002H2301~   "
31817|NCT02640651|"~     The purpose of this pilot study is to determine whether transcranial direct current~     stimulation safely and effectively improves symptoms of ADHD.~   "
31818|NCT02640638|"~     The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can~     improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral~     outcomes, and decrease the racial difference in selected birth outcomes among African~     American and White women, compared to individual prenatal care.~   "
31819|NCT02640625|"~     The primary objective of this study is to assess the safety of probiotics in cART-treated~     immunologic non-responder (INR) patients with chronic HIV infection.~      The secondary objectives are to i) explore the biological effects of probiotics in combined~     antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii)~     investigate differences between cART-treated HIV-infected INR and non-INR patients with~     regards to gut microbial composition and mucosal barrier function.~   "
31820|NCT02640612|"~     The main objective of this trial is to provide long-term safety, PK, and immunogenicity data~     on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who~     have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of~     patients with drug-related AEs during the treatment phase. The secondary objective in this~     trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:~        -  the change from Baseline in DAS28 (ESR) at Week 48~        -  the proportion of patients meeting ACR20 response criteria at Week 48~        -  the proportion of patients who meet the ACR/European League Against Rheumatism (EULAR)~          definition of remission at Week 48~        -  the proportion of patients with EULAR response (good response, moderate response, or no~          response) at Week 48.~   "
31821|NCT02640599|"~     Investigators will use a stationary bike protocol to investigate whether patients with post~     concussion syndrome benefit from adding exertion training to a vestibular rehabilitation~     program.~      Investigators examine the effect of aerobic exercise testing and training on individuals~     with concussion who are currently experiencing symptoms and examine the effect of aerobic~     exercise in combination with traditional vestibular rehabilitation.~   "
31822|NCT02640586|"~     The purpose of this study is to investigate if MRI scans performed after neoadjuvant~     radiotherapy can predict the therapeutic response of rectal cancer following preoperative~     chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in~     the future.~   "
31823|NCT02640573|"~     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle~     cell disease with typically higher hemoglobin and milder or later disease complications.~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped.~     This can result in painful episodes, serious infections, and damage to body organs. One~     medication used to treat sickle cell disease is hydroxyurea.~      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with~     sickle cell anemia. These include a reduction in the frequency of pain crises and acute~     chest syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients~     but HbSC patients were not included in the large clinical trials used to test hydroxyurea in~     SCD, so less is known about how HbSC patients respond to hydroxyurea.~      The purpose of this research study is to see if hydroxyurea, a medication given to many~     patients with the most common type of sickle cell, those who are homozygous for the sickle~     mutation (HbSS), helps individuals who have HbSC. The investigators will see if it helps by~     giving a questionaire when the medication is started, and then every two months at a clinic~     visit. The questionaire, called the AdultsQLTM 3.0 Sickle Cell Disease Module, measures~     quality of life. The investigators will also see how hydroxyurea changes laboratory test~     numbers, and blood thickness.~   "
31824|NCT02640560|"~     In Italy, few data about anaphylaxis due to peanuts in pediatric age are available,~     conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been~     collected.~      Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and~     shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory~     (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).~      Parent of food allergic children will compile a food allergy questionnaire (questions about~     general information on the family, on life and food habits, on indoor environment, on health~     status, on clinical aspects of the allergy, on the access to diagnostic and treatment~     resources).~      Parent of healthy children will compile a control questionnaire (questions about general~     information on the family, on life and food habits and on indoor environment) The 1-year~     survey will determine the frequency of anaphylaxis in allergic outpatient children.~   "
31825|NCT02640547|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported~     outcomes (PRO) and work productivity data of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) + Ombitasvir (OBV), +/- Dasabuvir (DSV), +/- Ribavirin in chronic~     hepatitis C virus infected participants.~   "
31826|NCT02640534|"~     The purpose of this trial is to test if the combination of enzalutamide and metformin in~     patients with castration resistant prostate cancer CRPC progressing on androgen deprivation~     therapy ADT is more effective compared to enzalutamide alone. The half of the patients will~     receive the experimental treatment combination, enzalutamide and metformin, while the other~     half will receive enzalutamide alone.~   "
31827|NCT02640521|"~     The overall goal of this study is to adapt and preliminarily validate an intervention based~     on evidence based approaches to assist smoking parents and other family members of~     inner-city children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt~     existing guideline-based materials used in adult medicine to create a system- and~     provider-level intervention for pediatrics and (2) to evaluate feasibility and acceptability~     of (a) procedures to recruit inner-city, ethnic minority parents and (b) intervention~     procedures, and to estimate intervention effects.~   "
31828|NCT02640508|"~     The overall purpose of this study is to determine the overall response rate, efficacy and~     safety of the combination of eribulin and Lenvatinib.~   "
31829|NCT02640495|"~     The spread of artemisinin resistant falciparum malaria presents new challenges to both the~     control and treatment of malaria. Loss of ring stage susceptibility to the artemisinins~     might jeopardize the use of parenteral artesunate as the first line drug for the treatment~     of severe falciparum malaria.~      The purpose of this study is to assess the effect of artemisinin resistance (defined by a~     Kelch13 mutation with known functional significance) in P. falciparum malaria requiring~     parenteral artesunate treatment on lactate clearance parameters.~   "
31830|NCT02640482|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in~     adults with genotype 2 chronic hepatitis C virus (HCV) infection.~   "
31831|NCT02640469|"~     Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are~     available as hand disinfection options. The purpose of this study is to determine the~     relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with~     water after scrubbing is complete versus dry hand rubs with alcohol.~   "
31962|NCT02639013|"~     Early detection of intra-abdominal hypertension is essential to the prevention of abdominal~     compartment syndrome and requires close surveillance of intra-abdominal hypertension in~     patients at increased risk. intra-abdominal hypertension measurements are often taken by the~     bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension~     monitoring is prompted by critical care nurses.~   "
31832|NCT02640456|"~     The aims of the study are:~        1. Explore the bacteriology of para- and retropharyngeal abscess.~        2. Validate the bacterial findings by exploring antibody development against F.~          necrophorum, F. nucleatum and S. pyogenes.~        3. Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal~          abscesses.~        4. Characterize patients with para- and retropharyngeal abscess.~        5. Compare the concentration of amylase in para- and retropharyngeal abscesses and neck~          abscesses without relation to the pharynx or salivary glands.~        6. Perform gene-sequencing of F. Necrophorum strains, and compare these with strains~          recovered from patients with acute tonsillitis, peritonsillar abscess, and Lemierre´s~          syndrome.~   "
31833|NCT02640443|"~     The investigators will evaluate whether sulfamethoxazole, a sulfamide antibiotic, improves~     the symptoms of primary PREPL deficiency (hypotonia-cystinuria syndrome and isolated PREPL~     deficiency).~   "
31834|NCT02640430|"~     BACKGROUND: Studies have shown that COPD patients with bronchial hypersecretion have~     increased risk of acute exacerbations. FREE ASPIRE is an electro-medical device which~     removes bronchopulmonary secretions noninvasively, without using a suction catheter and~     without generating airway pressure.~      AIM: To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the~     clearance of bronchial secretions in COPD patients METHODS: Forty severe and very severe~     COPD patients with mucus and reduced cough will be evaluated. Group comparison will be made~     between Intervention group using VAKÜM system (Free Aspire®), and Control group using~     traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day).~     Primary outcomes are changes in arterial blood gases exchanges, in perceived dyspnea and in~     symptom of bronchial encumbrance.~      EXPECTED RESULTS: A higher significant reduction of the perceived dyspnea and of perceived~     bronchial encumbrance is supposed in the Intervention group. Additional benefits among the~     secondary outcomes are also hypothesized in the same group.~   "
31835|NCT02640417|"~     This is a double-blind, randomized study in parallel groups of subjects presenting with low~     back pain. Randomized subjects will receive treatment for 60 days with either a combination~     of nucleotides and vitamin B12 or vitamin B1+B6+B12.~   "
31836|NCT02640404|"~     The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers,~     children, adolescents, and adults~      Objective:~        -  To describe the safety profile after each and any dose (when applicable) of Menactra~          vaccine in participants aged 9 months to 55 years for registration.~   "
31837|NCT02640391|"~     The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical~     test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing~     in patients with quiescent ulcerative colitis (UC).~   "
31838|NCT02638675|"~     The objective of this randomized control trial is to examine whether incentives-for-steps~     (i.e. $1 per day step count goals are reached) increase daily step counts among physically~     inactive hospital employees.~   "
31839|NCT02638662|"~     The effect of stress on IVF outcomes.~   "
31840|NCT02638649|"~     This is a pilot observational feasibility study of the ability of paramedics to assess~     thoracic ultrasound findings in the prehospital environment. The primary goal of the study~     is to determine whether paramedics are able to accurately assess for sonographic B-lines in~     patients with undifferentiated shortness of breath at least 80% of the time in the~     prehospital environment using a portable ultrasound (U/S) device.~   "
31841|NCT02638636|"~     The purpose of this study is to examine if an internet-based exposure therapy is effective~     in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.~   "
31842|NCT02638623|"~     The investigators are testing the hypothesis that administering 2L of body temperature~     warmed lactated ringer's intravenously prior to surgery can optimize the postoperative and~     recovery of patients undergoing total hip and total knee arthroplasty.~   "
31843|NCT02638610|"~     The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid~     and Ocular Surface Surgeries.~      Study design: an interventional study that will be conducted at the ophthalmology~     department, Meir hospital, Kfar Saba, Israel.~      the study will include 60 healthy patients, at the ages of 40-80, which are candidates for~     eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion~     repair.~      The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient~     will undergo a full ophthalmologic examination including relevant assessment of the specific~     eyelid pathology.~      The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet~     filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take~     place before surgery, and two weeks, three months and six months after surgery.~   "
31844|NCT02638597|"~     This project will test whether gemfibrozil, a well-studied medication for high cholesterol,~     will help people stop smoking nicotine cigarette smoking. The study will also test whether~     gemfibrozil decrease cravings for cigarette and the desire to smoke.~   "
31845|NCT02638584|"~     This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the~     patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric~     Cancer and investigated Prevention of gastrointestinal bleeding.~   "
31846|NCT02638571|"~     The overall purpose of the study is to evaluate nutrition education interventions to promote~     pulse incorporated complementary food to the wider rural community through the government~     system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of~     young children (6 to 24 months). The hypothesis is that nutrition education improves mothers~     knowledge, attitude and practice of pulse incorporated complementary food and improves~     dietary intake of iron and zinc and nutritional status of young children.~   "
31857|NCT02640287|"~     Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present~     poorly understood, although a recurrent mutation (L265P MYD88) has recently been described.~     Unlike other lymphoproliferative disorders, there is a defect in isotype switching,~     mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis~     technology, our group showed that MW had a specific proteomic profile, and one of the~     differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .~      The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6~     (genetic or epigenetic modification) in comparison with other lymphoid malignancies and~     normal B cells.~   "
31847|NCT02638558|"~     Split-dose cleansing regimens for colonoscopies, independently from the type of laxative~     used, are now recommended over full (one day)-dose regimens from all the major guidelines.~     It is wellknown that splitting the dose (half of the dose the night before and half the day~     of the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher~     chance of identifying mucosal lesions. This is crucial both in terms of achieving a~     high-quality colonoscopy and in terms of time and money saved.~      Still, there are some issues about compliance and tolerability with split-dose regimens. Two~     recent prospective works have shown that only a small number of patients (33%) chooses the~     split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are~     forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is~     before 10 a.m. The most common concerns are about early wake-up, travel interruption and~     fear of incontinence. Both these papers state that strategies to reduce this noncompliance~     are needed.~      The investigators aim to prove whether an active action (an oral explanation before the~     colonoscopy about why split-dose regimens are better) may improve patients' compliance in~     endoscopies scheduled in the early morning (from 8 to 10 a.m).~   "
31848|NCT02638545|"~     The current treatment regimen of patients with septic shock requires a sufficient~     hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore,~     aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total~     peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines~     is often needed. Because sepsis is usually associated with adrenergic receptor and~     post-receptor abnormalities, the efficacy of such treatment regimens often gradually~     decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest~     that α-2 agonists increase pressor responsiveness following lipopolysaccharide~     administration. This study will assess the effects of the sedation with dexmedetomidine (α-2~     agonist) on norepinephrine requirements in patients with septic shock.~   "
31849|NCT02638532|"~     The specific aim of this outcomes study is to assess if the volume of fat that is injected~     into the foot is retained at 6 months, to determine the retention over time, and assess the~     quality of the bone before and after treatment. We will also correlate adipose stem cell~     characteristics to the fat retention over time.~   "
31850|NCT02640378|"~     Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.~   "
31851|NCT02640365|"~     MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal~     formulation is designed to extend plasma circulation and to increase accumulation in the~     tumor through the enhanced permeability and retention (EPR) effect.~      This study introduces a new concept of combining free and nanoliposomal drugs.~   "
31852|NCT02640352|"~     The aim of the present study is to test the efficacy of the combination of two probiotic~     bacteria in reducing the severity of upper respiratory tract infections (common cold) in~     healthy children attending day care or school. The probiotic bacteria used are Lactobacillus~     plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9~     CFU/tablet and day and will be consumed for a period of 12 weeks.~   "
31853|NCT02640339|"~     -  To determine whether retinal abnormalities, as measured by high definition optical~          coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a~          clinical biomarker to monitor disease progression overtime in patients with Parkinson~          disease.~        -  To establish whether these measures can be used to identify patients with PD in the~          premotor phase.~        -  To define the rate of progression of retinal abnormalities in PD (both in the motor and~          premotor stages) for potential use as a clinical outcome measure~   "
31854|NCT02640326|"~     It is common practice to insert a Foley catheter into the bladder to drain urine during and~     after a lung resection. Recently, there has been increasing interest in the potential risks~     associated with this catheterization, particularly with regard to infection. As thoracic~     surgery adopts minimally invasive surgical techniques, the need for urinary catheterization~     during surgery is being questioned since these less invasive surgeries are known to result~     in less post-operative acute pain, shorter length of stay, and other outcomes that tend to~     decrease overall anesthetic needs for this patient population. Thus, there is a need to~     investigate whether patients who have had a minimally invasive lung resection truly need the~     Foley catheter at all. This will be achieved by assigning patients to either an experimental~     no-catheter group or the standard of care routine urinary catheter group to determine if~     patients with no catheter experience different rates of complications. This pilot study will~     primarily determine if such a study is feasible and will test the suitability of new patient~     quality of life tools. Secondarily, the study will look to see if there is a difference in~     post operative urinary complications between the groups. Should this study prove to be~     feasible, the information learned will be used to determine the sample size and requirements~     for a fully powered trial, in order to definitively determine whether a Foley urine catheter~     is a necessary procedure in the course of a minimally invasive lung resection.~   "
31855|NCT02640313|"~     Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a~     sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such,~     is able to identify active inflammatory sites. We hypothesize that 18F-choline is also~     highly taken up in vulnerable plaques in comparison to the stable ones.~   "
31856|NCT02640300|"~     Clozapine has been demonstrated to be clinically superior to other antipsychotics in~     treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines.~     Because it is relegated to use in TRS, guidelines require that it only be used after other~     antipsychotics have failed; accordingly, clinicians routinely contend with stopping the~     previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous~     and potentially severe side effects, the issue of clozapine titration has frequently been~     addressed, although to our knowledge no study has, as of yet, assessed the comparability of~     gradual vs. immediate antipsychotic discontinuation in switching to clozapine. To address~     the gap in knowledge specific to clozapine, the investigators conducted a pilot, 8-week,~     double-blind, randomized controlled trial examining immediate vs. gradual antipsychotic~     discontinuation in patients with schizophrenia undergoing a switch to clozapine.~   "
31880|NCT02639988|"~     The purpose of this study is to determine whether patients with rheumatoid arthritis and~     type 2 diabetes experience a more severe disease course compared to control patients with~     osteoarthritis and type 2 diabetes~   "
31858|NCT02640274|"~     The European guidelines of cardiovascular disease prevention recommend treatment modalities,~     such as lifestyle changes in order to minimize the risk of further cardiac event after a~     myocardial infarction (MI). However, a considerable gap exists between guidelines and their~     implementation in clinical practise. Further, less is known about the impact of different~     interventions on patient's knowledge, skills and confidence necessary for self-management~     after MI.~      Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led~     counselling programme together with usual care for patients early discharged after MI on~     self-management behaviour.~   "
31859|NCT02640261|"~     The objective of our observational prospective study will be to compare, for women treated~     for infertility and included in a ICSI program, the implantation rate and delivery rate~     obtained after the transfer of a single blastocyst , chosen in a group of patients on the~     basis of the embryo morphology and in the other group on the basis of both embryo morphology~     and follicular fluid cytokines content.~      100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously~     stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone,~     who have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC),~     will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus~     r-LH , according to the standard established by our clinical practice.~      Patients will be part of one of the following groups:~      Group 1: single embryo transfer on day 5, according to standard embryo morphological~     criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo~     morphological criteria and levels of cytokines measured in the individual FF.~   "
31860|NCT02640248|"~     The investigators have devised a simple method to continuously measure the CP using an~     invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to~     monitor arterial or central venous pressures. The investigators have previously confirmed~     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable~     agreement of the IPMS readings with the values obtained from a standard manometer (gold~     standard). In the current study, we will prospectively evaluate the relationship between the~     patient's head position and CP in patients undergoing otolaryngological surgery and also~     measure the oxygen concentration in the oropharynx to determine the potential risk of an~     airway fire.~   "
31861|NCT02640235|"~     The study is to evaluate the effectiveness and safety of CELSTAT vs active control.~   "
31862|NCT02640222|"~     The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and~     Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data~     from SNIIRAM (French data base).~   "
31863|NCT02640209|"~     Open-label pilot study to determine safety and efficacy of CART-19 cells in combination with~     ibrutinib. The target dose will be 1-5x10xE8 CART-19 transduced cells administered via split~     dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3. 15 evaluable subjects (adults) with~     relapsed or refractory CLL/SLL who have achieved partial response or stable disease on~     ibrutinib therapy will be eligible to receive CART-19 therapy.~   "
31864|NCT02640196|"~     The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would~     reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated~     easy and difficult airways. The investigators have considered to assess the efficacy of each~     device in manikins before considering to evaluate them in patients undergoing thoracic~     procedures.~      Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for~     DLT intubation participated in this randomised crossover study. Following a brief~     demonstration and two practice attempts, participants were volunteered to insert a DLT using~     the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and~     difficult airway simulators in a computer-generated randomized sequence. The primary~     endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of~     intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to~     intubation; defined as an attempt took longer than 150 seconds, were recorded.~   "
31865|NCT02640183|"~     The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25~     mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic~     hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace~     general anesthesia that may be required for some cases of office hysteroscopy.~   "
31866|NCT02640170|"~     The purpose of this registry is to monitor the rate of recurrence in patients who undergo~     cancer surgery.~   "
31867|NCT02640157|"~     The purpose of this study is to compare the safety and efficacy of ABT-493/ABT-530 to the~     combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 chronic~     hepatitis C virus (HCV) infection.~   "
31868|NCT02640144|"~     This is a prospective, double blind randomized controlled trial. In this study we will~     investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when~     known or discovered cartilage damage greater than International Cartilage Research Society~     score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the~     cartilage damage. A set of 3 consecutive injections will be administered and follow up of~     physical examination and questionaries will be done.~      Our null hypothesis is that the administration of hyaluronic acid will show decrease pain~     and quicker rehabilitation and return to normal activity in patients with grade 2 and higher~     cartilage damage that had gone through knee arthroscopy.~   "
31869|NCT02640131|"~     The burden of sexual dysfunction after prostate cancer surgery is responsible for the single~     greatest impact on patient/partner health-related quality of life; substantially more so~     than concern for cancer recurrence, or any other post-surgery side-effect. Consequently,~     there is a great need for progressive and distributable sexual health rehabilitation~     interventions designed to uphold intimacy and optimal sexual health. If the~     biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1)~     an empirically-based intervention that helps patients/partners maintain optimal~     health-related quality of life after prostate cancer surgery, and 2) a highly structured~     protocol and manualized intervention that is translatable to other treatment groups (e.g.~     radiation therapy) and University/Community-based hospitals.~   "
31890|NCT02639858|"~     A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or~     metastatic head and neck squamous cell carcinoma~   "
31870|NCT02640118|"~     Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose~     disposal and endogenous glucose production (regulated by insulin and glucagon); also the~     rate of gastric emptying constitutes an important determinant of PPG levels 1. The~     short-acting glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the~     treatment of type 2 diabetes. It increases glucose-dependent insulin secretion, suppresses~     glucagon secretion and reduces gastric emptying of meals 2. These three mechanisms most~     likely constitute the weightiest mechanisms behind the potent impact of lixisenatide on~     exaggerated PPG excursions in patients with type 2 diabetes - which often are normalised~     during lixisenatide treatment 3. However, the separate impact of lixisenatide-induced~     reduction of gastric emptying (independently of the pancreatic effects) has been difficult~     to determine. Importantly, treatment with lixisenatide also decreases appetite and food~     intake and may, like native GLP-1, increase energy expenditure 4. So far an exact~     demarcation of the pancreatic and extrapancreatic effects of lixisenatide in humans remains~     to be established.~      The present project serves to determine whether effects of lixisenatide on gastric emptying,~     appetite, food intake and resting energy expenditure are dependent on the endocrine~     pancreas.~      The study is a randomised, placebo-controlled, double-blinded, cross-over study.~      12 healthy persons and 12 pancreatectomized patients (i.e. patients who have had their~     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected~     to two experimental days on which they will undergo a liquid meal test followed by a fasting~     period and finished off with an ad libitum meal with lixisenatide and placebo, respectively.~   "
31871|NCT02640105|"~     Cluster headache (CH) is one of the most painful primitive headaches. Developments in~     neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic~     system, which is similar in patients with addictions. CH has strong links to the vascular~     system but there is no study measuring endothelial function in CH sufferers.~   "
31872|NCT02640092|"~     The purpose of this protocol is to evaluate the longitudinal change in tau burden using~     [18F]MNI-798, tau targeted radiopharmaceutical compared to baseline in prodromal, mild, and~     moderate AD subjects and in similarly-aged HV subjects.~   "
31873|NCT02640079|"~     The purpose of this study is to test the feasibility and efficacy of a brief group therapy~     treatment program focused on reducing pain catastrophizing in adolescents and young adults~     (ages 16-25) with menstrual pain.~   "
31874|NCT02640066|"~     Acute viral respiratory infections are among the most common causes of hospitalization in~     the pediatric population. The usual presentation of viral respiratory tract infections~     (VRTI) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite.~     Up to 50% of children will have at least one viral-induced wheezing illness by school age.~     Currently treatment of VRTI is essentially supportive and no specific and efficient~     treatments are known. Given the lack of effective medications, current treatment for severe~     viral lower respiratory tract infection (LRTI) in infants relies on supportive measures~     only. These measures include supplementation of oxygen, monitoring of apnea, nasal/gastric~     tube feeding or intravenous fluids, and, if required, respiratory support with nasal~     bi-level positive-airway pressure. VTRI therefore represent an important unmet need for~     improved treatment strategies. Acupuncture's effect on has also been studied. Acupuncture~     has been shown to be a safe and effective in various respiratory tract inflammations. A~     review published in 2011 have found that acupuncture is safe for pediatric patients.~     Acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has~     yet to be studied. Since the current standard of care is supportive care only, using~     acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory~     distress, and shorten hospitalization.~   "
31875|NCT02640053|"~     This randomized pilot clinical trial studies topical cryotherapy (a procedure in which an~     extremely cold liquid is used to freeze and destroy abnormal tissue) in reducing pain in~     patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain~     syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling,~     swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling~     syndrome of acute aches and pains. Topical cryotherapy may help relieve pain from peripheral~     neuropathy or acute pain syndrome caused by chemotherapy.~   "
31876|NCT02640040|"~     The study aims to evaluate the clinical result of Combined Surgery in Management of~     Congenital Pseudarthrosis.~   "
31877|NCT02640027|"~     Fractures of the supracondylar region of the humerus are among the most common pediatric~     injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced~     fractures (Type I), as well as those with history of elbow trauma, have been traditionally~     managed with non-surgical immobilization. Recently published clinical guidelines support~     such practice, based on the result of two prospective studies in which either collar and~     cuff or posterior splint immobilization were used. When compared to collar and cuff~     immobilization, posterior splints resulted in better pain relief within the first two weeks~     of injury; however, critical outcomes, including the incidence of cubitus varus,~     hyperextension, and loss of reduction, were not reported.~      While posterior splints appear to be an attractive option for the treatment of non-displaced~     pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints~     for the treatment of such injuries reported a small proportion of fractures demonstrating~     displacement. The potential for non-compliance with the use of removable devices, especially~     in the older pediatric population, is also a concern.~      The use of a removable immobilization that can reliably maintain fracture alignment,~     minimize the risk of non-compliance, and result in similar outcomes as those obtained with~     regular casting could be advantageous: It appears that such immobilization could be removed~     easily and safely at home, potentially resulting in a lower number of patient visits,~     decreased health-care costs, and higher patient/parent satisfaction.~      Telemedicine, defined as the use of telecommunication and information technologies in order~     to provide clinical health care at a distance, has been seldom used in the field of~     pediatric orthopaedics. Commonly mentioned attributes of telemedicine include improved~     access to healthcare providers, cost containment and increased healthcare efficiency,~     quality care improvements related to patient satisfaction, and potential reduction in travel~     time for patients and families.~      The purpose of this randomized, controlled, prospective study is to assess telemedicine as a~     tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators~     hypothesize that using telemedicine will result in comparable clinical outcomes as those~     obtained in patients treated in a clinical facility, with increased patient satisfaction and~     decreased healthcare costs.~   "
31878|NCT02640014|"~     The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge~     of oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting~     way to increase the unresponsiveness in severe food allergies. However little is known about~     it´s long-term outcomes, immunological mechanisms and there are no previous studies about~     cost-utility of OIT.~   "
31879|NCT02640001|"~     In patients on mechanical ventilation, it is not known whether the identification of S.~     aureus in LRT samples improves the performance of its nasal detection.~      To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for~     more than 48 hours after major heart surgery: comparing the performance of the diagnostic~     technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.~   "
31881|NCT02639975|"~     The proposed trial a Randomized, Double Blind, Placebo Controlled first in-human Study to~     Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy~     Volunteers (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre,~     randomized, double-blind, dose escalation study without therapeutic benefit, in which~     PBF-677 will be administered as single, oral, ascending-dose to volunteers.~      Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in~     groups of 8 participants; in each dose level participants will be randomized to active drug~     or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be~     administered to humans, as a safety measure a stepwise drug administration will be performed~     in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups:~     Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and~     tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1~     placebo and after further 48h of safety and tolerability assessments a third subgroup of 4~     volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters~     of corresponding dose level the process will replicate one week afterwards in the following~     dosages.~      The principal variable safety and tolerability of PBF-677 will be evaluated with physical~     records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted~     before, during and after study course). Assessment of the pharmacokinetic profile (Maximum~     plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach~     Cmax (tmax), Area under the time-concentration curve to zero to time t (AUC0t), and~     Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.~   "
31882|NCT02639962|"~     Identifying patients who are at risk for a future myocardial infarction, is still one of the~     biggest challenges in cardiology.~      In this study the investigators will investigate culprit lesion in patients with NSTEMI and~     the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe~     and identify plaques that may be vulnerable. The investigators will also describe changes in~     characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a~     matching group of stable angina pectoris (SAP) patients.~   "
31883|NCT02639949|"~     Nonadherence to medication is a major obstacle to successful treatment of renal transplant~     patients. This study has two primary aims. The first is to test whether a culturally~     sensitive cognitive-behavioral adherence promotion program could significantly improve~     medication adherence to tacrolimus prescription. Participants will be randomly assigned to~     either group CBT or to standard care. The second aim is to pilot a novel strategy of~     adherence measurement - unannounced telephone pill counts, which has been shown to be a~     valid and reliable means to measure medication adherence in other patient populations.~     Participants will be recruited from waiting area of the kidney transplant clinic at SUNY~     Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be~     conducted prior to start of the intervention in order to establish baseline adherence and~     three pill counts will be conducted post-intervention. Tacrolimus trough concentration~     levels will also be collected as an additional biological measure of adherence.~   "
31884|NCT02639936|"~     Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube~     test) in immunocompromized patients~   "
31885|NCT02639923|"~     The aim of this study is to investigate the early serum measurement (<6h after injury) of~     mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions~     (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions~     (CCT neg.).~      S100B serum levels will be measured in both groups. The usual risk factors for the~     occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded.~     Additionally, a group of healthy individuals will serve as a control group.~   "
31886|NCT02639910|"~     This is a single arm, multicenter, open-label study of MOR00208 combined with idelalisib in~     adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as~     single agent or as part of combination therapy.~   "
31887|NCT02639897|"~     Direct laryngoscopy and intubation is an essential initial aspect of airway access during~     general anesthesia. To perform the procedure effectively, it requires adequate mouth~     opening, head and neck movement, and a normal temporo-mandibular joint mobility. Any issue~     with the above three results in a compromised upper airway at the outset and the condition~     is known as anticipated difficult airway, i.e. an airway that is difficult to access with~     conventional laryngoscopy and intubation methods. To overcome the difficulty, either one has~     to resort to newer advanced technique and equipment or the available conventional technique~     needs to be refined and modified to suit the requirement. While the former requires~     extraordinary expertise and finances, an option difficult to achieve in developing~     countries; the latter warrants focused interest to develop alternative approach with the~     same set of equipments.~      Since submucous fibrosis and the associated restricted mouth opening have taken the~     proposition of an epidemic owing to widespread use of betel nut and tobacco; these patients,~     when requiring surgery, are difficult candidates for GA and airway control. The fact that,~     when they arrive as pre-surgical candidates, they have variable degree of mouth opening~     restriction, which if approached with a strategy, may be amenable to conventional control of~     airway. If investigators paint all the patients with mouth restriction as difficult airway,~     it will result in uncalled surgical, economic, health system and psychological burden.~     Therefore, it is prudent to undertake research relating to refinement of airway access~     techniques with the easily available, cheap and user- friendly equipment (conventional~     laryngoscope), such that a proportion of above stated burden can be reduced.~      In view of the above, investigators plan to undertake a study to enhance our working~     knowledge with a conventional laryngoscope (Macintosh) to facilitate ways to control the~     airway difficulty secondary to mouth opening restriction. Investigators believe that the~     prospective knowledge thus generated would help us identify whether there is a feasibility~     of conventional airway management or an alternative advanced access technique is needed in~     the first place. This will prevent undue cancellations, delayed surgeries, and patient~     morbidity.~   "
31888|NCT02639884|"~     Patients with obstructive sleep apnea (OSA) could have several anatomical causes of~     obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause~     of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX)~     to induce sleep. The goals of the study are to (1) confirm airway obstruction with~     endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment~     of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX~     sedation alone.~   "
31889|NCT02639871|"~     There is no curative treatment available today in Huntington disease (HD) despite the~     identification of the mutated gene 20 years ago. Nonetheless, safe and promising therapeutic~     strategies targeting brain energy metabolism are now becoming available.~      In view of the small effect sizes of any clinical parameter in HD, robust neuroimaging~     biomarkers reflecting brain energy metabolism are therefore urgently needed to better assess~     the potential of therapeutics targeting the mitochondria, and especially the Krebs cycle.~     Identifying such biomarkers at the presymptomatic phase in HD also provides a unique window~     for therapeutic intervention, which can be used as a proof-of-concept for the real challenge~     of tomorrow's medicine: the prevention of neurodegeneration HDeNERGY is an observational~     study consisting of the transfer of methods from preclinical to clinical studies and their~     application in HD. HDeNERGY aim at optimizing MRI/MRS methods to study the dynamics of brain~     energy metabolism. At the CENIR (Centre de neuro-imagerie et de recherche, Paris) the~     determination of creatine kinase rate will be first validated in healthy volunteers (n=20)~     and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic~     individuals (n=20) and controls (n=20) together with the methods previously validated in HD~     patients (Mochel et al., 2012b) to determine the ratio of inorganic phosphate (Pi)/~     phosphocreatine (PCr) during visual stimulation in presymptomatic individuals. The Chemical~     Exchange Saturation Transfer (CEST) method on the 3T clinical scanner of CENIR will be first~     validated in healthy volunteers (n=20) and then applied to the selected cohort of early~     affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20).~      The cerebral synthesis rate of creatine phosphate and of brain glutamate concentrations and~     pH values will be compared between controls, HD patients and HD presymptomatic individuals,~     and correlated with clinical parameters (age, BMI, UHDRS).~   "
31891|NCT02639845|"~     The purpose of this study is to determine if an eye drop video monitoring device can~     accurately assess (as compared to a patient's own log or a proprietary software) the exact~     amount and time of eye drop delivery to a patient's eye. It is our belief that the~     experimental device will help patients to be more compliant by: 1) providing a viewable~     format so patients can see what is happening when they are applying their drops 2) providing~     greater accuracy to doctors regarding when and how much medication was used 3) providing~     greater accuracy to doctors and patients regarding how much medication was actually~     delivered to a patients eye.~   "
31892|NCT02639832|"~     The purpose of this research study is:~        -  To test blood for the presence of tumor derived circulating tumor cells (CTCs) or~          circulating tumor DNA (ctDNA) using an investigational medical device called the~          LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be~          investigated to obtain genetic information that may be useful to treating physicians in~          understanding disease.~        -  To test blood for natural killer cells (NK cells), which are part of the body's natural~          immune defense against tumors. A device called the NK VueTM Kit will be used for this~          test.~      The LiquidBiopsy® is a new investigational device. An investigational device is one that is~     not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an~     investigational device in the United States but is approved in Canada and South Korea as a~     class II device.~      If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells~     can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is~     able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too~     small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be~     found in the blood. Genetic information can then be recovered from these cells or DNA to~     look for genetic changes that are related to the abnormal growth in a tumor. This will~     potentially allow researchers to study tumor cells or tumor DNA from a blood sample instead~     of a biopsy sample. This may influence cancer diagnosis, treatment and drug selection in the~     future.~      NK cells occur naturally in the body and kill tumor cells. This study will measure the~     activity of the NK cells in blood. A strong correlation between low NK cell activity and~     increased circulating tumor cells in blood has been reported.~   "
31893|NCT02639819|"~     This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in~     ICH patients.~      Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting~     within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will~     be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid~     over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head~     will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower~     extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be~     followed in the clinic 30-90 days post discharge for functional status.~   "
31894|NCT02639806|"~     This study evaluates the outcomes of stroke patients treated for intravascular thrombectomy,~     using either a local anesthetic with sedation, or a general anesthetic. Historical data will~     be used for those treated with the local anesthetic, and prospective data will be used for~     those treated with the general anesthetic.~   "
31895|NCT02639793|"~     The study will assess the atrial fibrillation burden recorded By implantable loop recorder~     at 12 and 24 months compared to baseline. The patients with clinical indication fo catheter~     ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual~     radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and~     cryoablation.~   "
31896|NCT02639780|"~     The investigators will define procoagulant properties of packed red blood cells and~     investigate whether packed red blood cells from certain donor populations are prone to~     induce procoagulant states.~   "
31897|NCT02639767|"~     The purpose of this study is to evaluate the safety of combining chemotherapy at different~     doses with a specific type of radiation therapy delivered to the entire lining of the lung~     to find out what effects, if any, it has on people. This radiation technique is called~     pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining~     of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself.~     When given after chemotherapy, pleural IMRT has demonstrated promising results with respect~     to keeping mesothelioma under control longer. However, the investigators want to determine~     if giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies~     will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor~     under control for a longer period of time than chemotherapy followed by pleural IMRT.~   "
31898|NCT02639754|"~     Young men who have sex with men (MSM) in low- and middle-income countries often do not seek~     out HIV testing, are unaware of their HIV-positive status, and do not receive early medical~     care, compromising their health and contributing to downstream disease incidence. This~     situation is of great concern in post-socialist countries of Eastern Europe, where stigma~     about HIV/AIDS and same-sex behavior are great, HIV epidemics are still increasing, and the~     health needs of young MSM are rarely acknowledged or addressed. The planned research will be~     conducted in Sofia, Bulgaria, where MSM account for nearly half of HIV infections. The study~     will be conducted in two phases.~   "
31899|NCT02639741|"~     The investigators designed a randomized double-blind placebo-controlled trial to evaluate~     the effect of preoperative single dose of oral melatonin and vitamin C administration on~     postoperative analgesia in patients undergoing elective major abdominal surgery.~   "
31900|NCT02639728|"~     The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee~     stimulates colonic activity, most notably in the transverse/descending colon, in magnitude~     similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1]~     Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory~     threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is~     significantly higher than after water intake. This may result in an earlier desire to~     defecate. [2] Coffee has also been shown to have an effect on defecation by increasing~     rectal tone by 45% (measured with a barostat) thirty minutes after consumption. [3]~   "
31929|NCT02639442|"~     The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to~     treat Lower Urinary Tract Symptoms (LUTS) due to BPH.~      During the procedure an implant is delivered into the prostate tissue obstructing the~     urethra and restricting urine flow. The delivery system uses an electro-cutting blade to~     perform a circular and superficial incision, in which the implant is placed. Such an~     implant, with the shape of an open ring, expands the obstructed area, reducing the fluid~     obstruction through the prostatic urethra.~   "
31963|NCT02639000|"~     Single center randomized study including 388 women aged less than 39 years, performing in~     vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs)~     improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.~   "
31901|NCT02639715|"~     The aim of this observational study is to describe for the first time a complete set of~     morphometric and morphokinetic parameters of frozen-thawed human embryos in order to select~     the embryo with the highest implantation potential. These parameters will be correlated with~     (1) data of the fresh embryos and their subsequent survival, the evolution of the contact~     surfaces between surviving blastomeres and the resumption of mitosis; (2) patient~     characteristics and clinical outcome of frozen-thawed embryos and (3) a comparison between~     embryos cryopreserved with vitrification or the slow method regarding these parameters will~     be performed.~      This project aims to introduce new evaluation criteria of the frozen-thawed embryos to~     improve success rate of FET cycles. By establishing new precise, reliable and non-invasive~     measurable parameters, we aim to (1) select which supernumerary embryos are at chance to~     survive the freezing/thawing procedures, (2) establish cut off parameters for the survival~     rate of the embryo, (3) assess implantation, pregnancy and live birth rates depending on the~     developmental characteristics after thawing and after 24h of culture.~      Our strategy for improving the outcome of FET cycles is based on the study of morphometric~     and morphokinetic parameters in frozen-thawed embryos and the correlation with~     embryological, clinical and cycle parameters. Transferring a well-defined thawed embryo with~     a high implantation potential may lead towards an increase in the implantation and life~     birth rate and an increase in the cumulative live birth rate with a reduction of the IVF~     costs in order to optimize the health-economic situation of reproductive medicine.~   "
31902|NCT02639702|"~     Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics;~     for example, it is recommended that agents with a short plasma half-life be administered~     multiple times per day. However, to date, several randomized controlled trials (RCTs) have~     shown no differences in clinical outcomes between once- and twice-daily dosing of various~     antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option~     regardless of plasma half-life. This would apply to clozapine as well; however, there have~     been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms~     of efficacy and tolerability. To address this gap in the literature, the investigators shall~     conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch~     to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine~     twice a day.~   "
31903|NCT02639689|"~     Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device~     in deficits levator foot of central origin.~   "
31904|NCT02639676|"~     Pregnant mothers who develop high blood pressure and other vascular problems (preeclampsia)~     deliver babies with increased neonatal health problems, which include lung disease and~     vascular complications, later in life. Investigators will evaluate whether infants of~     mothers with preeclampsia have evidence for impaired development of the lungs and blood~     vessels.~   "
31905|NCT02639663|"~     Leboride is a dental support device that was developed for reducing pain during active~     labor. It is made of an inert material, placed in the woman's mouth and does not disturb~     breathing, talking, or any other activity expected during labor. It is a single-use device,~     each user receives a new one.~      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that~     improve women's breastfeeding experience, and increase breastfeeding rates.~   "
31906|NCT02639650|"~     This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin~     as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.~   "
31907|NCT02639637|"~     The purpose of this study is to understand how dipeptidyl peptidase IV (DPP4) inhibition in~     diabetics affects hemodynamic parameters and sympathetic activation in the setting of~     increasing concentrations of neuropeptide Y, an endogenous peptide. The central hypothesis~     is that DPP4 inhibition decreases degradation of neuropeptide Y, resulting in increased~     vasoconstriction and sympathetic activation.~   "
31908|NCT02639624|"~     This is a non randomized crossover trial investigating whether changing the pattern of~     bicarbonate administration during hemodialysis will result in the more efficient filtration~     of highly protein bound solutes. The experimental group will be dialyzed with low~     bicarbonate dialysate for the first half of dialysis then switched over to normal~     bicarbonate dialysate for the second half. The control group will be dialyzed entirely with~     normal bicarbonate dialysate. The two groups will switch one week late and patients will~     serve as their own matched controls for a completely standard dialysis and one that is split~     into two halves with different bicarbonate concentrations.~   "
31909|NCT02639611|"~     The primary purpose of this study is to evaluate changes in shoulder tightness, chest~     tightness, and general pain related to post-mastectomy reconstructive surgery with tissue~     expansion in women who are randomized to receive acupuncture treatment immediately after~     surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture~     treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.~   "
31910|NCT02639598|"~     Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic~     options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as~     compared with 50 mg/day topiramate.~   "
31911|NCT02639585|"~     We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real~     practice.~   "
31930|NCT02639429|"~     Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts~     to require induction of labor because of increased rates of obstetric complications~     including pregnancy related hypertensive disorders, diabetes, and prolonged gestations.~     Several studies have shown that obese women experience increased labor duration and oxytocin~     needs when compared to normal-weight women. This in turn results in increased rates for~     unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest~     disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with~     increasing class of obesity. The investigators hypothesize that obese pregnant women and~     unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus~     vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal~     misoprostol alone.~   "
31964|NCT02638987|"~     An experimental study will be conducted to evaluate the effect of a single dry needling~     session on surface EMG activity (primary outcome measure), muscle tone, elasticity,~     stiffness and pain (secondary outcome measures) of the upper trapezius, in female office~     workers with trapezius myalgia.~   "
31912|NCT02639572|"~     Siloss® (Azurebio, Madrid, Spain) is a synthetic and inorganic bone graft material and is~     composed of a dicalcium phosphate anhydrous (monetite), hydroxyapatite (HA), and amorphous~     silica and trace amounts of zinc. It is manufactured by a proprietary process avoiding high~     temperatures. This results in a non-sintered material with a high specific surface area (65~     m2/g) and high interconnected porosity (60%) that favour a high degree of interaction with~     its biological surrounding. It is fully resorbable, being replaced by natural bone, thereby~     avoiding the disadvantages of nonresorbable materials that interfere with normal processes~     of bone remodelling. Siloss® is resorbed both by a dual process of slow dissolution of its~     components and by active cellular remodelling. Controlled dissolution of Siloss® releases~     Ca, P, Si and Zn that stimulate regeneration processes while larger pores are formed~     allowing colonization of osteoclasts and osteoblasts involved in bone remodelling. It~     functions as a bioactive temporary scaffold maintaining the desired volume while it promotes~     bone regeneration and is being replaced by new vascularized bone. The alloplastic property~     of the graft material avoids the risk of infection and adverse inflammatory reactions. Also,~     resorption of Siloss® prevents possible adverse effects associated with long permanence of~     low resorbable materials.~      The aim of the present study is to clinically and radiographically evaluate the efficacy of~     bone graft material (Siloss ®) in the treatment of intrabony defects.~   "
31913|NCT02639559|"~     Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling~     and volunteer unrelated donors. Unfortunately, this process requires four to six days of~     G-CSF injection and can be associated with side effects, most notably bone pain and rarely~     splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs~     on the same day as BL-8040 administration. This study will evaluate the safety and efficacy~     of this novel agent for hematopoietic progenitor cell mobilization and allogeneic~     transplantation based on the following hypotheses:~        -  Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient~          CD34+ cells (at least 2.0 x 10^6 CD34+ cells/kg recipient weight) following no more~          than two leukapheresis collections to support a hematopoietic cell transplant.~        -  The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in~          prompt and durable hematopoietic engraftment following transplantation into~          HLA-identical siblings with advanced hematological malignancies using various~          non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD~          prophylaxis.~        -  If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data,~          then the study will continue and include recruitment of haploidentical donors.~   "
31914|NCT02639546|"~     This open-label, dose-escalation study is designed to evaluate the safety, tolerability,~     pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult~     participants with solid tumors with known or potential kinase pathway activation for which~     standard therapy has proven to be ineffective or intolerable and for which no curative~     standard-of-care treatment options exist. The study will be conducted in two stages: a~     dose-escalation stage and an expansion stage at the recommended dose.~   "
31915|NCT02639533|"~     Fibromyalgia syndrome represents a spectrum disorder characterized by widespread chronic~     pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models~     explaining the causes of the disease have focused on the reduced pain inhibitory systems~     activity, that allow low intensity stimuli to be processed easier, and that finally amplify~     pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which~     demonstrated to be effective reducing pain. Different studies in animals have shown that it~     works reducing the liberation of neuronal messengers, which slow the conduction of pain~     signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are~     still few studies aiming to explain how it actually works in patients with fibromyalgia,~     though.~      A better understanding of the mechanisms by which Pregabalin reduces pain in patients with~     fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus,~     the investigators propose to study in real-time the electrical, vascular and hormonal~     response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin.~     The vascular response will be assessed using functional near infrared spectroscopy (fNIRS)~     neuroimaging techniques. The electrical response will be assessed using Transcranial~     Magnetic Stimulation (TMS). The hormonal response will be assessed in blood, measuring~     neurotrophins (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis~     Factor). These responses will be studied in consideration of the patients' characteristics~     that will be assessed using validated scales.~      Taken into account the above considerations, a crossover, double-blinded randomized clinical~     trial is proposed. In the investigators' study, patients and healthy volunteers will be~     asked to visit the investigators' laboratory in three opportunities: one for a baseline~     assessment, and the other two to test the effects of either Pregabalin 150 mg PO or Placebo.~     All participants will eventually receive both, Pregabalin and Placebo. In each visit a brain~     hemodynamic, electrical, hormonal and clinical evaluation will be performed.~   "
31916|NCT02639520|"~     To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic~     treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured~     by the proportion of patients who received an additional antibiotic treatment for acute~     lower uUTIs during the trial.~   "
31917|NCT02639507|"~     The purpose of this research is to evaluate the effectiveness of vitrectomy for the~     treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to~     leak, leading to swelling of the central retina (macula), and decreased vision. Removing the~     vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes.~     Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.~   "
31918|NCT02638519|"~     This study involves imaging participants' brains using MRI. The goal is to develop a~     high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain~     magnetic resonance imaging, which can provide more sensitive measurement of brain function,~     facilitating the development of drugs for more successful treatment of Alzheimer's disease.~   "
31944|NCT02639247|"~     This study will evaluate the efficacy, safety, and tolerability of treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks~     and of sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in direct-acting antiviral~     (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without~     cirrhosis who have not received prior treatment with a regimen containing an inhibitor of~     the HCV NS5A protein.~   "
31945|NCT02639234|"~     This is an open label phase 2 study to evaluate the combination of Vigil™ and nivolumab in~     advanced or metastatic NSCLC that is progressive on or after one prior platinum-based~     systemic therapy. Patients meeting study eligibility criteria will receive Vigil™ every 2~     weeks (for a minimum of 4 and a maximum of 12 doses) and nivolumab every 2 weeks. The~     combination of Vigil™ and nivolumab will demonstrate a higher objective response rate (ORR)~     than the historical ORR of single agent nivolumab in patients with advanced NSCLC.~   "
31919|NCT02638506|"~     Background : Headaches are a common presentation for children consulting to the Emergency~     Department (ED). However, only few studies have evaluated the rapid pain improvement~     provided by medications in the acute management of headaches in the pediatric population.~      Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to~     placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to~     severe headaches.~      Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will~     be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All~     children eight to 18 years old who will present to the ED with headaches as a main chief~     complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be~     recruited. Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum~     dose of 100 mcg) or similar volume of a placebo solution via an atomizer. Co-administration~     of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups~     if not received in the previous 4 hours. The primary outcome will be the mean pain rating~     reduction at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60~     minutes, patient's and parental satisfaction levels, percent of being pain free, sedation~     score, immediate and within 72 hours adverse events, additional ED analgesics and other~     medications, length of ED stay, disposition outcomes, hospital admission rate and ED revisit~     rate within 72 hours. The primary analysis will use an intention-to-treat approach to~     compare mean pain score reduction between the two groups using a Student's T-test. The~     sample size of 60 participants per arm was calculated to have a power of 80% to identify a~     difference of 10 mm in the VAS.~      Expected results : Our study might demonstrate that INF provides additional pain relief for~     children presenting to an ED with headaches. Providing INF could relieve their symptoms more~     quickly, potentially improve patient's and family's satisfaction, possibly reduce the length~     of their ED stay and consequently, have a significant impact on patient quality of care and~     cost-effectiveness.~   "
31920|NCT02638493|"~     Male participants taking tenofovir-emtrictabine (TDF/FTC) will provide semen and blood~     samples which will be analyzed to better understand the pharmacology of antiretroviral~     therapy in the male genital tract.~   "
31921|NCT02638480|"~     The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee~     rehabilitation device on the incidence of postoperative flexion contracture.~   "
31922|NCT02638467|"~     Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with~     TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient~     recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias~     that limit TKI adequate administration. Although rare, this event happens in a proportion of~     4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a~     normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant~     procedure is therefore intended in providing a sustained hematopoiesis that will allow an~     early treatment with an adequate dosing of TKI. The transplant procedure planned in our~     study is built on all available evidences to provide the lowest incidence of acute and~     chronic GvHD (Graft-versus-host disease). Therefore, a bone marrow will be the preferential~     source and a GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and~     Cyclosporine/Methotrexate will be used according to standard current experience in the field~     of family and unrelated donors. The pre-transplant TKI will be continued until aplasia will~     develop, in order to decrease the tumor load as much as possible.The use of TKIs shortly~     after transplant carries the risk of inhibiting the newly transplanted hematopoietic cells,~     as Kit, an important kinase in normal bone marrow cells, is frequently blocked by Abl~     inhibitors. The use of bosutinib as post-transplant therapy is justified by the lack of Kit~     inhibition that distinguishes bosutinib from all other TKIs, and which could allow a minimal~     inhibitory activity against the transplanted normal bone marrow.~   "
31923|NCT02638454|"~     Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered~     quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt~     to anabolic stimulation may be a factor that contributes to sarcopenia. This project will~     provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle~     to changes in gene expression after anabolic stimulation.~   "
31924|NCT02638441|"~     The aim of this study is to determine the prevalence of psychological affection in infertile~     egyptian women~   "
31925|NCT02638428|"~     The purpose of this study is to evaluate the efficacy and feasibility of combination~     chemotherapy with target agents according to the result of targeted deep sequencing in~     pediatric patients with relapsed/refractory solid tumor or AML.~   "
31926|NCT02639481|"~     Patients with acquired brain injury (ABI) often suffer from severe disorders of~     consciousness (DOC), such as coma, unresponsive wakefulness syndrome (UWS), or minimally~     conscious state (MCS). This study examines the effect, a novel robotic rehabilitation device~     (the Erigo®Pro system) has on the recovery of consciousness of DOC patients. The device~     enables patients to be verticalized very early during acute neurorehabilitation and includes~     robotic leg movement training as well as functional electrical stimulation (FES) of leg~     nerves. Patients will be randomly allocated to one of three treatment groups: (i) control~     group with standard physiotherapy without the device, (ii) device treatment without FES, and~     (iii) device treatment with FES. Time until recovery of consciousness, rehabilitation~     outcome, and amount of complications will be the outcome variables.~   "
31927|NCT02639468|"~     Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when~     compared to reference measurements performed via right heart thermodilution~   "
31928|NCT02639455|"~     Poor oral health can greatly impact quality of life and can also impact overall health. For~     instance, research suggests that poor oral health may be associated with systemic diseases~     such as diabetes, heart disease, and stroke. Therefore, there is a need to investigate the~     causes of poor oral health.~      The idea that athletes may have a propensity for dental caries has been gaining traction.~     There have been recent reports of high levels of dental caries, dental erosion and~     periodontal diseases among elite soccer players compared to the general public and in~     athletes from a wide range of sports. However, to date, no studies have investigated the~     oral microbiome of athletes.~      Many factors affect the development of dental caries, including host factors, diet, and the~     microorganisms present in the oral cavity. More than 700 types of bacterial species have~     been detected in the oral cavity, and some have been identified to play a significant role~     in the development of oral disease. Streptococcus mutans is the main species involved in~     dental decay with various lactobacilli also involved in the disease process. Treponema~     denticola, Porphyromonas ginigivalis, and Aggregatibacter actinomycetemcomitans are the main~     species involved in periodontal disease. It is not currently known if changes in the~     collective oral microbiome foster or impede the development of these pathogens.~      Complex microbe-host interactions occur to allow for the progression of oral disease, with~     host nutrition and hygiene playing a significant role. Endurance athletes widely consume a~     variety of sport drinks, gels, and energy bars for supplementation of electrolytes and~     carbohydrates. The consumption of these foods leads to pH drops in the oral cavity and may~     contribute to tooth erosion and demineralization. Oral disease may also be exacerbated by~     the fluid and electrolyte deficit that impedes saliva flow during exercise. However, several~     studies have failed to demonstrate a clear link between sports drinks and an increased risk~     of dental caries among athletes.~      Dental caries are caused by microorganisms in the oral cavity. These microbes may be~     affected by host factors or nutrition in the progression of oral disease. Due to the~     documented prevalence of dental caries in athletes and the lack of clear connection between~     sports drinks and dental caries, the investigators propose to investigate any correlation~     that may exist between exercise and the oral microbiome.~   "
31946|NCT02639221|"~     The principal aim of this study is to obtain safety and tolerability data when PXT002331 is~     administered orally as single and multiple doses to healthy subjects.~   "
31931|NCT02639416|"~     Children with complicated severe acute malnutrition (SAM), such as inability to take~     adequate feeds, infection and diarrhoea, require in-patient management. Despite following a~     well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality~     often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term~     poor growth or recurrence of SAM.~      It has long been recognized that children with SAM have intestinal inflammation and that~     this persists despite management according to WHO guidelines. The inflammation is thought to~     result from increased exposure to microbial pathogens in the gut in areas with poor~     sanitation. The damaged lining of the intestine impairs food digestion and absorption,~     likely allows gut bacteria to enter the blood stream to cause sepsis and also exposes the~     gut immune cells to microbial and food antigens causing the inflammation to persist. Failure~     to treat the intestinal inflammation is likely to contribute to the poor response to~     treatment and poor long-term outcomes in many children with SAM.~      The intestinal inflammation seen in SAM is very similar to that which occurs in food~     intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In~     these conditions, the inflammation is treated very effectively with hypoallergenic~     (elemental) and anti-inflammatory (polymeric) formulas. These are nutritionally complete~     feeds that have a similar composition to the feeds used for nutritional rehabilitation in~     SAM.~      We aim to undertake a pilot study to see if an elemental and/or polymeric formula are~     tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to~     learn more about the intestinal inflammation in general that occurs in SAM by observing~     carefully the effect of these specific formulae and to do in-depth metabolic analyses.~   "
31932|NCT02639403|"~     Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal~     carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have~     been published more than two decades ago and were based on 2D conventional RT, which is~     nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the~     management of symptomatic rectal cancer are still lacking. The aim of this prospective study~     was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with~     symptomatic obstructive rectal cancer.~   "
31933|NCT02639390|"~     The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm~     function after stroke. The investigators previously developed a novel training protocol that~     combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons~     that allow coordinated whole limb training in reach and grasp tasks with both virtual and~     real objects. However, the robot has a very large inertia and friction, and only gross grasp~     patterns are available. In development work, the investigators will significantly modify the~     AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of~     retraining a wide range of functional activities. In the subsequent testing phase, a~     clinical trial will examine the effects of robotic training in chronic stroke subjects.~   "
31934|NCT02639377|"~     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a~     chemical adjuvant for the treatment of peri-implant mucositis in single implants compared~     with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month~     follow-up.~   "
31935|NCT02639364|"~     The aim of this study is to assess the effects and safety of the early application of~     BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and~     adequate PEEP level in ARDS patients .~   "
31936|NCT02639351|"~     Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium~     Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults~     (18-45 years of age).~   "
31937|NCT02639338|"~     This study will evaluate the efficacy, safety, and tolerability of treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks~     and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in adults with~     chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis who have not previously~     received treatment with direct-acting antiviral (DAA) therapy.~   "
31938|NCT02639325|"~     Background:~      Some people with brain tumors have seizures related to the tumor. This is called~     tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain~     tumor as possible without causing problems. Researchers think this may improve the outcome~     for people with brain tumors. It may completely relieve or greatly reduce the number of~     seizures they have.~      Objectives:~      To evaluate people with brain tumors that are associated with seizures and to offer surgical~     treatment. Also, to study how surgery affects seizures.~      Eligibility:~      People age 8 and older who have a brain tumor with associated seizures. They must be willing~     to have brain surgery to treat their epilepsy.~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have a medical history and physical exam.~      Participants will be admitted to the hospital at NIH. They will have~      Medical history~      Physical exam~      Neurological exam~      Tests of memory, attention, and thinking~      Questions about their symptoms and quality of life~      Blood drawn~      They may also have:~      MRI or CT scan. They will lie on a table that slides in and out of a machine that takes~     pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.~      Video electroencephalography monitoring. Electrodes will be placed on the scalp. The~     participant s brain waves will be recorded while doing normal activities. Participants will~     be videotaped.~      Participants will keep a seizure diary before and after surgery.~      Participants will have surgery to remove their brain tumor and the brain area where their~     seizures start.~      They will stay in the hospital up to a week after surgery.~      Participants have for follow-up visits at NIH.~   "
31947|NCT02639208|"~     The number of patients 60 and older with breast cancer is increasing as our population ages.~     Despite the fact that the majority of breast cancers occur in patients 60 and over, these~     patients are consistently under-represented in clinical trials. Because patients 60 and~     older are an under-studied group, investigators do not have detailed information on the side~     effects and experiences for these patients receiving chemotherapy. Understanding the side~     effects patients receiving chemotherapy experience is an important part of this study.~      In addition, past research has shown that having poor social support can affect quality of~     life, mood, and outcomes for people with cancer. However, few studies in the past have~     focused on improving the quality of life and support systems that patients have while they~     receive treatment.~      This research study is evaluating how engaging in an online support community may improve~     the experience of older patients receiving chemotherapy.~   "
31991|NCT02638363|"~     The aim of this study is to investigate the predictive value of emotion regulation and~     attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety~     disorders in a naturalistic setting.~   "
34041|NCT02611505|"~     The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in both participants with varying stages of hepatic~     impairment and healthy participants.~   "
31939|NCT02639312|"~     Background:~      Some head and facial abnormalities are rare and present at birth. Others are more common,~     and may not show up until puberty. These conditions have different causes and~     characteristics. Researchers want to learn more about these conditions by comparing people~     with face, head, and neck abnormalities to family members and to healthy volunteers without~     such conditions.~      Objectives:~      To learn more about abnormal development of the face, head, and neck. To determine their~     genetic variants.~      Eligibility:~      People who have not had surgery for facial trauma:~      People ages 2 and older with craniofacial abnormalities (may participate offsite)~      Unaffected relatives ages 2 and older~      Healthy volunteers ages 6 and older~      Design:~      Participants will be screened with medical history and physical exam focusing on head, face,~     and neck~      Participants may be followed for several years. Visits may require staying near the clinic~     for a few days.~      A visit is required for the following developmental stages, along with follow-up visits:~      Age 2 6~      Age 6 10~      Age 11 17~      Age 18 and older~      Visits may include:~      Medical history~      Physical exam~      Questionnaires~      Oral exam~      Blood and urine tests~      Cheek swab: a cotton swab will be wiped across the inside of the cheek several times.~      Cone beam CT scan (CBCT): x-rays create an image of the head, face, teeth, and neck.~     Participants will~      stand still or sit on a chair for about 20 minutes while the scanner rotates around the~     head.~      Photos of the head and face~      Offsite participants will provide:~      Copies of medical and dental records~      Leftover tissue samples from previous surgery~      Blood sample or cheek swab~   "
31940|NCT02639299|"~     Background:~      Malaria is a serious infection caused by a parasite. People get malaria when an infected~     mosquito bites them. Malaria can cause major health and social problems in places were~     malaria is common, such as Africa but can also affect travelers who have never been exposed~     to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine,~     antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited~     under a general screening study in order to see if are qualified to join a future malaria~     study.~      Objective:~      To screen healthy volunteers to see if they are eligible to join investigational malaria~     studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines,~     or prevention regimens. They may also involve controlled human malaria infection trials.~      Eligibility:~      Healthy people ages 18 50~      Design:~      Participants will first be prescreened by phone.~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Participants may go more than 1 year without joining a clinical trial. If this happens, they~     may be re-contacted to see if they still want to be part of this screening protocol. Those~     who still want to participate and have had relevant medical changes will be rescreened.~   "
31941|NCT02639286|"~     Background:~      Partial lipodystrophy is a deficiency of body fat in parts of the body (usually the arms and~     legs). People with partial lipodystrophy often get high blood triglyceride (fat) level,~     insulin resistance, diabetes and other problems. Researchers think the new drug ISIS 304801~     can help treat health problems caused by partial lipodystrophy.~      Objective:~      To see if ISIS 304801 will improve blood fat (triglyceride levels), diabetes, and liver~     disease, and reduce some risks for heart disease caused by partial lipodystrophy.~      Eligibility:~      Adults at least 18 years old with partial lipodystrophy.~      Design:~      Participants will be screened during a 1-week stay at NIH. They will have:~      Blood and urine tests~      Physical exam.~      Assignment to get either the study drug or placebo.~      Instructions for how to inject the drug.~      Body measurements.~      Heart tests.~      Participants will give themselves injections of the drug or placebo once a week at home.~     Some may test blood sugar by finger pricks. They will have monthly phone calls and nurse~     visits to take blood tests.~      After 4 months, participants may continue the study for 1 year. All participants will get~     the study drug.~      Participants will have study visits at NIH every 4 months. These may include:~      Insulin sensitivity measurement: Insulin and sugar will be infused through 2 intravenous~     (IV) lines in the arms. Blood will be drawn.~      Sugar and fat metabolism measured by IV infusions and blood tests.~      Special x-ray scan to measure body fat.~      Liquid meal then blood collected by IV catheter in the arm.~      Magnetic resonance imaging scans.~      Neck ultrasound.~      Questionnaires.~      Liver biopsy (optional)~      Injection of heparin (a blood thinner) before a blood test.~      After finishing the drug, participants will have 1 nurse visit and 1 visit to NIH.~   "
31942|NCT02639273|"~     Background:~      Drugs like nalmefene interfere with opioid receptors. This might reduce drinking. The gene~     OPRM1 determines opioid receptor functions. Researchers want to see if nalmefene affects~     people s responses to alcohol cues. They also want to compare how nalmefene affects people~     with different forms of OPRM1.~      Objectives:~      To test nalmefene s effects on alcohol self-infusion and responses to alcohol cues. To test~     the role of different forms of OPRM1 on these effects.~      Eligibility:~      Healthy heavy drinkers ages 21 60:~      Women: over 15 drinks weekly~      Men: over 20 drinks weekly~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Heart, blood, and urine tests~      Questionnaires~      Participants will have three 10-hour visits and one 2-hour follow-up visit. They will take a~     taxi. Visits are about 1 week apart.~      Before visits, participants cannot drink alcohol for 1 day or take medicine for 3 days.~      All study visits:~      Questionnaires~      Heart monitor~      Two-hour alcohol session: A needle guides a thin plastic tube into a vein in each arm. One~     tube receives alcohol. The other draws blood. Participants give themselves alcohol by~     pressing a button on a computer.~      Relaxing at the center until breath alcohol falls below 0.02 percent, or for 3 hours.~      Visits 2 and 3:~      Swallowing nalmefene or placebo.~      One-hour brain MRI: Participants lie on a table with a coil on their head. They press~     buttons in response to computer cues.~      Follow-up visit: participants will discuss their drinking habits.~   "
31943|NCT02639260|"~     Three kidney diseases that affect both children and adults are minimal change disease (MCD),~     focal segmental glomerulosclerosis (FSGS) and membranous nephropathy (MN). These diseases~     are characterized by proteinuria (protein in the urine) and in the cases of FSGS and~     membranous nephropathy, a tendency to progressive scarring of the glomerulus (the filtering~     units of the kidneys) that leads to end-stage kidney disease. Several therapies are~     available for these diseases, but these therapies do not provide lasting reduction in~     proteinuria for many subjects. In the current study, carried out at the NIH Clinical Center,~     we are testing a new therapy, ManNAc. ManNAc is a naturally occurring uncharged sugar that~     cells use to produce negatively charged sialic acid. Kidney cells attach sugars such as~     sialic acids to proteins and lipids (resulting in glycans), and these assist in cell~     function. Mouse models of the inherited muscle disease GNE myopathy, which is due to sialic~     acid deficiency on muscle glycans, responded favorably to oral ManNAc therapy and a clinical~     trial of ManNAc is ongoing in GNE myopathy subjects. There is evidence that some subjects~     with MCD, FSGS or MN do not put enough sialic acids on glomerular proteins and so ManNAc~     therapy may increase sialic acid production and sialylation of glomerular proteins in these~     subjects. For the present study, we will recruit 12 subjects who have MCD, FSGS or MN. Each~     subject will stay at the NIH Clinical Center for 11 days to receive oral ManNAc. The primary~     purposes of the study are to determine: 1) the safety of ManNAc in subject s with kidney~     disease; and 2) the ManNAc and sialic acid metabolism related to ManNAc in subjects with~     kidney disease. Concentrations of ManNAc and sialic acid will be measured in plasma at~     various times before and after dosing. If this study suggests that ManNAc is safe in subject~     with kidney disease, the results will be used to plan a longer-term study to determine~     whether it is effective at reducing proteinuria.~   "
31948|NCT02639195|"~     This study has two segments the first is a chart and outcome assessment of patients treated~     at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have~     completed multiple questionnaires as a standard of care for outcome monitoring in the clinic~     setting, no new data will be collected. The second segment is a prospective observational,~     online questionnaire based study of subjects with a history of SBO not treated at CP. Data~     on the impact of quality of life (QOL) over time of subjects not treated at CP will be~     assessed using the same questionnaire used as standard of care in the clinic twice, 90 days~     apart. This will be accomplished using the NIH Assessment Center, with subjects able to~     complete the questionnaires with ease via the internet. As this segment is observational,~     there is minimal risk to these subjects. The data obtained from the untreated subjects will~     allow for reporting of overall impact on QOL in this population, data that is not available,~     as well as provide a control group for assessment of improvement for interventions for SBO.~   "
31949|NCT02639182|"~     The purpose of this study is to evaluate the progression free survival (PFS), based on~     investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with~     metastatic renal cell carcinoma.~   "
31950|NCT02639169|"~     ABSTRACT The transplant allogeneic hematopoietic stem cell transplantation (HSCT Alo) is a~     therapeutic medical treatment carried out in combat various neoplastic hematologic~     disorders, congenital, genetic or acquired. In this procedure, which combines high-dose~     chemotherapy and or radiation and has a degree of high cytotoxicity, the patient goes for a~     social solitary confinement, which causes psychological distress, pain, anxiety, mood~     disorders and can lead to depression. The music therapy was applied and the purpose of~     decreasing the insulation. This is a randomized controlled study.~      Method: Apply the intervention of live music sessions through the techniques of music~     therapy; assess and quantify through the visual analog scale (VAS) and numeric. The~     dependent variables, pain, anxiety and mood of the participants selected randomly for the~     experimental group music therapy (EGM) n=50, and compare with the control group (CG) n=50,~     which received only the standard treatment.~   "
31951|NCT02639156|"~     To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary~     oral nutritional support compared with currently available alternatives.~   "
31952|NCT02639143|"~     This is a prospective, randomized, parallel design study to investigate that ticagrelor~     could attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation~     myocardial infarction (STEMI) patients. The anticipated duration of the study is~     approximately 9 months, including an anticipated enrolment period of 8 months and follow-up~     period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a~     one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The~     primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from~     STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.~   "
31953|NCT02639130|"~     To determine the extent to which the effects of treatment with LAF237 100 mg QD on glucagon~     secretion are mediated by Glucagon-like-peptide 1 (GLP-1) in type 2 diabetic patients and~     healthy subjects.~   "
31954|NCT02639117|"~     This is a Phase 1 single site study to evaluate the safety and efficacy of a combination~     therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using~     aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will~     receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions~     with topical application of ALA. The PDT will be first administered at 7+ 4 business days~     after the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business~     days.~      Primary Objective The primary objective of this study is to determine the safety of~     photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple~     BCC.~      3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination~     therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study~     subjects who has complete or partial response to the study treatment.~   "
31955|NCT02639104|"~     This study investigates one of the mechanism factors of neck pain. Cervical lordotic angle~     alterations affect the tension of serratus anterior muscle. Expected result that the long~     thoracic nerve can be affected in this situation, and could be observed the functional~     changes of the nerve with serratus anterior electromyographic findings.~   "
31956|NCT02639091|"~     Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY~     94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with~     mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell~     lung cancer.~   "
31957|NCT02639078|"~     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-0714 in healthy subjects.~   "
31958|NCT02639065|"~     This is a phase II, open-label, single arm, single-stage study. A total of 26 evaluable~     patients will be enrolled. If total number of patients free of disease relapse at 1 year is~     less than or equal to 15, the drug would not be considered for further study in this~     setting. After six patients are treated with at least one dose of study drug, they will be~     observed for a minimum of 60 days. During the 60-day observation period, further accrual~     will be halted to evaluate unacceptable toxicities warranting early closure of the trial~     defined as:~        -  Any definitive durvalumab-related death. A durvalumab-related death will be~          continuously monitored throughout the trial and the trial will be suspended for~          re-evaluation whenever such an event is confirmed.~        -  Any unexpected and previously unreported grade 4 toxicities definitely related to~          durvalumab.~   "
31959|NCT02639052|"~     The purpose of this study is to determine if Botox is effective in the treatment of an~     experimentally induced itch that mimics chronic itch in healthy volunteers.~   "
31960|NCT02639039|"~     The purpose of this study is to determine if trigger point dry needling (TDN) is as~     effective as cortisone injection (CI) in reducing pain and improving function in patients~     with greater trochanteric pain syndrome (GTPS).~   "
31961|NCT02639026|"~     The main purpose of this study is to determine how best to combine hypofractionated~     radiotherapy, MEDI4736, and tremelimumab and to determine how safe and tolerable~     hypofractionated radiotherapy, MEDI4736, and tremelimumab are when given together in~     subjects with metastatic, melanoma, non small cell lung cancer (NSCLC), breast cancer, and~     pancreatic cancer.~   "
31965|NCT02638974|"~     Women prisoners are more likely to commit suicide or self-harm than women in the community~     or male prisoners.~      Healthcare services have improved how they manage self-harm in the community and prisons.~     However, there has been little focus on the recovery of people with self-harm scars. Medical~     skin camouflage (MSC) is a British National Formulary-listed topical cream designed to cover~     skin conditions. Research on MSC has focused on its use with non-self-harm marks e.g. burns.~     The evidence from this research suggests that the cream helps women feel better and do more~     activities. There is little/no evidence about the effects of the preparation for women who~     self-harm and for prisoners.~      This research was funded by the National Institute for Health Research Research for Patient~     Benefit Programme. In the research the investigators will examine whether it is possible and~     practical to use MSC in prison. The investigators will ask prisoners and staff what they~     think about the cream. The research has four parts. In the first part the investigators will~     talk to groups of people from the prison about the best way to use the cream and how to~     measure its effects. In the second part the investigators will design a programme for the~     MSC application. The investigators will then train prisoners to apply the cream. The final~     part will involve 20 people using MSC for six weeks. The investigators will measure their~     mood, thoughts of self-harm and wellbeing before and after they use MSC. The investigators~     will compare these results with 20 people who have not used MSC (control group). All women~     taking part will be placed at random into the control or the treatment group. The control~     group will receive the cream after the research has ended.~      Potential benefits of this study may be an increase in self-esteem and quality of life for~     the women prisoners. As women recover they may be less likely to self-harm.~   "
31966|NCT02638961|"~     Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent~     form of HF in developed countries. Despite its increasing in prevalence, there is no~     evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether~     inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination~     of both improve exercise capacity as well as left ventricular diastolic function,~     biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.~   "
31967|NCT02638948|"~     The purpose of this study is to determine whether the study drug, BMS-986142, is safe and~     effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate~     response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF)~     Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142~     or placebo in 1:1:1:1 randomization for 12 weeks. Disease activity and safety will be~     assessed over the course of the study.~   "
31968|NCT02638935|"~     The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization~     can improve the diagnostic accuracy with respect to detection of malignancies, in particular~     for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in~     categories 3 and 4a according to a predefined VTIQ cut-off value of 3.5 m/s (37 kPa).~   "
31969|NCT02638922|"~     Objective~      To evaluate the phenotypic characteristics and diagnoses in a large cohort of 304~     consecutive girls referred due to tall stature. Furthermore, to evaluate the effect of oral~     administration of 17β-estradiol on predicted adult height in constitutionally tall statured~     girls.~      Design~      A single-centre retrospective observational study of 304 girls evaluated due to tall stature~     between 1993 and 2013.~      Setting~      Tertiary referral centre for pediatric endocrinology.~      Participants~      A total of 304 girls were evaluated for tall stature of whom 39 (13%) were excluded due to~     missing data, reclassification, overgrowth syndromes or associated comorbidities. Another 58~     (19%) girls did not fulfil auxological criteria for constitutionally tall stature (CTS),~     resulting in a total of 207 (68%) girls eligible for analysis.~      Main Outcome Measures~      The effect of oral treatment with 17β-estradiol on height, predicted adult height (PAH),~     final height and circulating hormones in constitutional tall statured girls.~   "
31970|NCT02638909|"~     The available data indicate that Ceritinib has substantial anti-tumor activity in patients~     with anaplastic lymphoma kinase (ALK) and ROS1 rearranged non-small cell lung cancer~     (NSCLC). This trial will investigate the potential of Ceritinib in patients with advanced~     gastrointestinal malignancies with ALK and ROA1 rearrangement, and for whom there is no~     available therapeutic option.~   "
31971|NCT02638896|"~     The primary objective of this study is to evaluate the efficacy of safety of etanercept dose~     reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have~     achieved a significant clinical response.~   "
31972|NCT02638870|"~     Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain~     and disordered defecation and is one of the most common gastrointestinal problems. In~     practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent~     abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing~     factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely~     used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis~     also exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless,~     over 40% of IBS patients receiving TCAs had no improvement in symptoms after treatment.~     Theoretically, if TCAs are used for IBS patients with hypersensitivity, its efficacy could~     be increased.~      Although rectal distension test might be used to identify hypersensitive patients with IBS,~     it has been used only for clinical research because it is painful for the patient. On the~     contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease~     and for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS~     patients reported higher pain score after colonoscopy than non-IBS patients. This has~     prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS~     patients with visceral hypersensitivity showing better treatment response of TCA than those~     without.~      The aims of the present study were to evaluate the colonoscopy-related pain perception and~     the treatment response of amitriptyline in IBS patients and to investigate the predictive~     values of the colonoscopy-related pain scale in identifying IBS patients with a response to~     amitriptyline treatment.~   "
31973|NCT02638857|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision~     multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of~     hepatocellular carcinoma.~      Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen~     T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial~     chemoembolization group and dendritic cell-precision multiple antigen T cells combined with~     transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks~     with a total of three periods. The mail clinical indicators are Progression-Free-Survival~     and Overall Survival.~   "
31992|NCT02638350|"~     The main objective is to assess the validation of the diagnosis early acute pulmonary edema~     in elderly patients with acute respiratory distress, admitted in a host of vital emergency~     services by lung ultrasound associated with the measurement of the inferior vena cava.~   "
31974|NCT02638844|"~     Assessment of right ventricular (RV) function in patients with acute respiratory syndrome~     (ARDS) is warranted because RV failure is frequent and associated with worse outcome.~     Transthoracic echocardiography is the cornerstone of RV assessment but it remains~     challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography~     (STE) is a widely available and reproducible technique that readily provides an integrated~     analysis of all segments of the RV. This study aims to investigate the accuracy of~     STE-derived strain parameters in assessing RV function during ARDS.~   "
31975|NCT02638831|"~     Comparative clinical study of Ketorol and Fastum gel in patients with Gonarthrosis and Low~     back pain.~   "
31976|NCT02638818|"~     The purpose of this study is to evaluate the impact of the quality of life in patients~     undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The~     Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large~     incision) to treat the patients cancer. The goal of this study is to see if there is any~     difference in quality of life between patients who undergo the laparoscopic or the open~     Whipple procedure. Surgical technique (minimally invasive versus open) will be at the~     discretion of the operating surgeon. Patients will not be randomized to a treatment arm.~      A subset of these patients will also be asked to take part in a pre- and postoperative~     in-depth interview to explore the lived experiences of patients with resectable pancreatic~     cancer.~   "
31977|NCT02638805|"~     A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650~     in subjects with Type 2 diabetes taking liraglutide and metformin.~   "
31978|NCT02638792|"~     The purpose of this study is to examine if an internet-based exposure therapy is more~     effective in reducing excessive worry amongst patients who suffer from this problem than is~     internet-based stress management training.~   "
31979|NCT02638779|"~     The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine~     storm, that participates to occurrence of organ failures and early death, followed by a~     compensatory anti-inflammatory response leading to immunosuppression, is now well~     established. This immunomodulating response results in a higher risk of secondary infections~     and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune~     status with time is crucial to guide therapy management. Objective of REALISM project is to~     demonstrate existence of this immunosuppression phase, by providing strong epidemiologic~     data for septic shock patients, but also by extension to other situations of inflammatory~     aggressions like severe severe trauma or burns, or major surgery. This project will provide~     tools to predict occurrence of secondary infections and guide patient management by~     comparing innovating immunomonitoring tools to reference tests non already adapted to a~     routine patient management.~      Targeted populations are adult patients hospitalized for septic shock, severe trauma~     (including severe burn) or major surgery and healthy volunteers, whom blood samples will~     serve to validate reference intervals of the two reference tests.~   "
31980|NCT02638766|"~     Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable~     KIT/PDGFR wild type GIST in the first line setting.~   "
31981|NCT02638753|"~     Although education on neurophysiology of pain improves disability, there are limited effects~     in pain intensity. Hypnosis is an approach that has proven useful in pain intensity and~     psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of~     its contribution in patients with chronic non specific low back pain. The aim of the study~     is to assess the efficacy of combining education on neurophysiology of pain and hypnosis in~     patients with chronic non specific low back pain in pain and disability outcomes.~   "
31982|NCT02638740|"~     Periodontal disease is a chronic inflammatory process accompanied by destruction of~     Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent~     especially in developing and underdeveloped countries affecting more than 80% population.~     Epidemiological studies have shown that about 10% of the adult population suffer from severe~     periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion~     is not strictly a localized process but may lead to systemic alterations in immune system.~     Various studies confirm the microbial etiology of periodontal disease.~   "
31983|NCT02638727|"~     The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial~     function and vasodilation in patients with coronary artery disease(CAD) by evaluating the~     brachial artery diameter in the antecubital area by ultrasonography.~   "
31984|NCT02638714|"~     A single arm, single center trial to assess the safety and efficacy of restoring function in~     damaged optic nerves using autologous purified populations of bone-marrow derived stem cells~     (BM-SCs) through a 24 month follow up period.~   "
31985|NCT02638701|"~     Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering~     SAH, ischemic stroke, and/or brainstem compression and many patients are not offered~     invasive treatment due to the futility of existing surgical methods. Consequently, there is~     demand for development of medical therapy for DVB aneurysms~   "
31986|NCT02638688|"~     Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the~     actual myomas volume after surgical removal, to clinically test the validity and usability~     of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess~     the reliability of different ultrasound methods to measure volume of uterine fibroids.~   "
31987|NCT02638415|"~     The purpose of the study is to compare the effect of HVPG-guided individualized therapy and~     non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.~   "
31988|NCT02638402|"~     To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human~     ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression~     profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in~     various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and~     tissue microarrays.~   "
31989|NCT02638389|"~     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of~     rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular~     organisations.~      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.~   "
31990|NCT02638376|"~     The objectives of this study are to evaluate the safety of and efficacy of the KXL system~     with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes~     having:~        1. Keratoconus (KC) ,~        2. Post LASIK ectasia (PLEc)~   "
31996|NCT02638298|"~     This is a study comparing two methods of dressing a post operative wound that are currently~     in practice. One method is a traditional dry gauze dressing. The other method is using a~     negative pressure dressing that provides gentle suction on the wound.~      The investigators will attempt to determine how well the use of post-operative negative~     pressure dressing reduces wound healing problems in patients who have surgery after~     radiation for a sarcoma in the thigh or leg.~   "
31997|NCT02638285|"~     To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary~     Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine~     Insemination (IUI) at Montaserieh infertility center.~      The present study comprised 309 infertile women candidate for IUI, randomly divided into LH~     surge and HCG groups (assign the number for each patient, odds number for LH and even number~     for HCG group). All patients were subjected to baseline ultrasound and received clomiphene~     citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when~     2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed~     after 24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after~     36 hours. The pregnancy rate was then compared in LH and HCG groups.~   "
31998|NCT02638272|"~     Whether radical debridement is necessary for the treatment of thoracic and lumbar~     tuberculosis is still questionable. The objective of this prospective randomized study was~     to compare the outcomes of radical debridement versus no debridement under different~     surgical procedures for the treatment of thoracic and lumbar tuberculosis.~   "
31999|NCT02638259|"~     Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate~     to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic~     drugs (DMARD) including methotrexate (MTX).~   "
32000|NCT02638246|"~     Self-management of diabetes can result in long-term benefits, such as delaying or preventing~     the development of a number of unnecessary health complications, and can even reduce the~     chances of premature death. Because adherence to diabetes self-management often declines~     during adolescence, it is critically important to develop interventions that increase~     adherence of diabetes self-management skills in this population.~   "
32001|NCT02638233|"~     Patients with chronic hepatitis C that are under opiate substitution therapy are likely to~     have psychiatric comorbidities such as depression; hence an Interferon based therapy is~     contraindicated. Additionally many of these patients have a borderline compliance, which~     makes it impossible to treat them at specialized hepatological centers. An ideal opportunity~     to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be~     administered daily together with the opiate substitution therapy at a low threshold~     facility.~   "
32002|NCT02638220|"~     This is an observational, multicenter study to determine the prevalence of Cerebrotendinous~     Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral~     cataracts. Patients who are potentially eligible for study participation will be identified~     through a chart review of patients who were seen at each study site prior to that site's~     initiation, or by entering care at the site while the site is participating in the trial.~   "
32003|NCT02638207|"~     Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients~     With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy~   "
32004|NCT02638194|"~     The primary purpose of this study is to examine the health effects of mainstream and~     secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well~     as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that~     inhalation of both mainstream and secondhand smoke generated by hookah produces adverse~     pulmonary and cardiovascular effects and alterations in serum levels of inflammatory~     biomarkers.~   "
32005|NCT02638181|"~     This study was to assess the distinct expression of matrix metalloproteinase 13,tissue~     inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular~     meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase~     13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular~     meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining~     method and western blot, and histological changes of trabecular meshwork were studied by~     Hematoxylin and Eosin staining.~   "
32006|NCT02638168|"~     Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these~     children have moderate to severe impairments in sleep, further exacerbating their already~     impaired academic, emotional and social functioning. In children with ADHD, 34% of~     prescribed sleep medications are antipsychotics that can cause marked weight gain and~     metabolic changes; alternate medications have either been found to be ineffective, difficult~     to tolerate or are largely unstudied in youth. Delayed sleep onset is strongly correlated~     with active symptoms of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better~     control of disruptive behaviors could improve sleep patterns and this application will~     assess if the extension of the therapeutic effects of CNS stimulants into the early evening~     improves sleep onset.~   "
32007|NCT02638155|"~     The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and~     compare the gastric myoelectrical activity between persons with food addiction (FA) and a~     control group. Additionally, this study will explore if differences exist between perceived~     hunger and satiety and hormone levels related to hunger and satiety in both groups. The~     comparison of the EGG readings and hormone levels is the next step in furthering our~     understanding of food addiction and how the physiology - not simply the symptomatology - of~     FA does or does not relate to weight management.~   "
32008|NCT02638142|"~     DiurHF is a prospective, multicenter, observational, study that compares continuous with~     intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous~     pilot study design was planned to anticipate a larger multicenter trial able to definitively~     evaluate the optimal loop diuretic use strategy in patients with ADHF.~   "
32009|NCT02638129|"~     The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone~     hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with~     placebo and rule out excess risk of major adverse cardiovascular events (MACE) when given in~     combination with standard of care in overweight and obese participants with documented~     history of CV disease.~   "
32010|NCT02638116|"~     The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of~     Ibrutinib in Healthy Adults.~   "
32012|NCT02638090|"~     The main purpose of this study is to see whether the combination of two drugs called~     pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also~     want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable.~     This study will compare the effects of the combination of two drugs called pembrolizumab and~     vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration~     (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and~     lung cancer and vorinostat to treat some forms of blood and lymph node cancers.~   "
32013|NCT02638077|"~     -  To find out the gap between real-world clinical practice and guideline recommendations~          in initial management of DTC patients~        -  To observe the characteristics of patients who achieved and did not achieve TSH target~          value after one year follow-up~        -  To assess response to initial therapy in patients who undergo total or near-total~          thyroidectomy and RAI remnant ablation after one year follow-up (according to an~          modified dynamic risk stratification system)~        -  To observe the recurrence status after one year follow-up~   "
32014|NCT02638064|"~     Assessment of surgiflo injection for treating pilonidal sinus disease~   "
32015|NCT02638051|"~     This trial studies efficacy and safety of combination of modulated electro-hyperthermia~     (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis~     with malignant ascites versus standard chemoinfusion (CDDP+5FU).~   "
32016|NCT02638038|"~     This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg~     and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with~     treatment-naïve RRMS for ≤ 3 years.~   "
32017|NCT02638025|"~     This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to~     exam patients with closed globe injury, and compared with slit lamp examination. The results~     showed that OCT can identify features of closed globe injury that were otherwise not visible~     on slit lamp biomicroscopy.~   "
32018|NCT02638012|"~     Current management strategies for severe and recurrent epistaxis secondary to Hereditary~     hemorrhagic telangiectasia (HHT) include surgical procedures, and uncomfortable nasal~     packing, both of which are often only short-term solutions. Floseal® may provide a~     non-invasive and less painful treatment option for epistaxis in HHT patients. This~     hemostatic agent has been shown to be an effective intraoperative hemostatic agent in a~     number of surgical procedures including endoscopic sinus surgery. It has also been shown to~     be favorable over nasal packing at controlling acute anterior epistaxis. Though the efficacy~     of using Floseal® for epistaxis in HHT patients has been proven anecdotally in the~     literature it has yet to be proven in a prospective clinical trial. The results of this~     pilot study will provide insight into the efficacy of using Floseal® in the management of~     severe epistaxis in HHT patients and to assist in the development of a full-scale~     prospective clinical trial.~   "
32019|NCT02637999|"~     Randomized open-label substudy of daily Myrcludex B plus pegylated interferon-alpha-2a in~     patients with HBeAg negative chronic hepatitis B co-infected with hepatitis delta~   "
32020|NCT02637986|"~     Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are~     associated with several maternal and fetal complications, including maternal septic shock,~     preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the~     prevention of UTIs in pregnancy is a very important goal. Several studies have suggested~     that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic~     administrations may have a role in preventing those infections. Nevertheless, this has never~     been tested in pregnant women.~   "
32021|NCT02637973|"~     The effects of empagliflozin treatment on hepatocellular lipid content, liver energy~     metabolism and body composition will be investigated in a multicentre, prospective,~     placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory~     pilot study in patients with newly diagnosed type 2 diabetes.~   "
32022|NCT02637960|"~     This study will investigate the efficacy and safety of fedovapagon in the treatment of~     nocturia in men with BPH.~   "
32023|NCT02637947|"~     The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the~     Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with~     ischemic scar VT in a low ejection fraction population.~   "
32024|NCT02637934|"~     Up to 30 women with known or suspected epithelial ovarian, fallopian tube, or primary~     peritoneal cancer will participate in two different imaging cohorts. The Biodistribution~     cohort will include up to 10 patients and the Dynamic cohort will include up to 20 patients.~     Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date~     will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and~     compare with PARP-1 activity in tissue.~   "
32025|NCT02637921|"~     Bone losses are well known to occur in response to unloading (in microgravity or during~     immobilisation) and in patients with chronic obstructive airway disease (COPD). However, it~     is unknown whether there is an interactive effect between hypoxia and musculoskeletal~     unloading upon bone and mineral metabolism. Fourteen non-obese men, who are otherwise~     healthy, will undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%),~     normobaric hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and~     normobaric hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on bone~     metabolism and phosphor-calcic homeostasis will be assessed (before and during each~     intervention, and 14 days after each intervention period) using venous blood sampling, 24hr~     urine collections, and peripheral quantitative computerized tomography (pQCT).~   "
32026|NCT02637908|"~     A training module has been developed for parents to effectively address stressors and~     demands of parenting and promote positive and supportive parent-child interactions. The~     purpose of this study is to implement the parent training program and evaluate the~     effectiveness of the program. Depending on the results, investigators expect core aspects of~     this module to be adaptable and modified or extended for parents of older children in the~     future to meet the needs of families across the stages of childhood development.~   "
32044|NCT02637674|"~     Uterus transplantation may enable women with uterine factor infertility to become pregnant~     and give birth.~      This study will explore the feasibility of a uterine transplant and eight subjects will~     undergo deceased donor uterine transplantation at CHU de Limoges.~      There phases involved in this study: Primary, Secondary and Tertiary Screening, Medical~     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up.~   "
32027|NCT02637895|"~     Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a~     traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after~     treatment with antidepressants; however, few patients experience complete symptom relief.~     There is a need to develop new treatments for PTSD.~      This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms.~     Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has~     not been approved by the Food and Drug Administration for the treatment of PTSD.~   "
32028|NCT02637882|"~     The patients will exposed to different intervention through three nights (ear plug, eye~     mask). 50 patients in the age range 18- 60 years admitted to ICU of Assiut university~     hospitals will be randomly allocated into into two groups (control group and intervention~     group).~   "
32029|NCT02637869|"~     The investigators are conducting a prospective analysis of the Alternative Payment~     Methodology (APM) demonstration project sites. The investigators' goal is to conduct a cross~     project analysis of findings. The investigators propose to use mixed methods to study~     processes and outcomes associated with the APM natural experiment in payment reform. The~     investigators hypothesize that Community Health Centers (CHCs) participating in the APM~     demonstration project will redesign their workflows to better focus on patient and~     population health needs, resulting in reallocation of financial resources, lower overall~     costs, changes in utilization patterns, and improved quality.~   "
32030|NCT02637856|"~     This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS~     who have had a suboptimal response to an adequate course of DMT. Participants will receive~     ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg~     total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up~     to 96 weeks). Anticipated time on study treatment is 96 weeks.~   "
32031|NCT02637843|"~     Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention =~     PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or~     the elbow (a. brachialis). It is well established that there is less risk of bleeding~     complications when using a radial access. The smaller diameters of the vessels in the~     forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This~     is associated with vascular spasm (spasm tendency). Ultimately this means that one may have~     to convert to access via a. femoralis.~      To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is~     unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain.~     Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath~     Coated (hereafter referred to as Slender sheath). This sheath is partly coated, partly~     made of a thinner material. Slender sheath thus has an outer diameter smaller than that of~     the sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as~     Standard sheath), although the inner diameter (lumen) is the same in the two sheaths. In~     turn, the Slender sheath is more fragile and far more expensive.~      The purpose of the present study is to evaluate whether use of slender sheath compared with~     standard sheath is Associated with less pain and fewer complications following CAG/PCI.~   "
32032|NCT02637830|"~     This study mainly compared the response of the artificial carious enamel lesions to~     remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel,~     MHDP and Buffer solutions.~      The lesions were then remineralised in an in situ model, with crossover and double blind~     design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of~     each demineralising protocol during 3 experimental phases (3 days each). The experimental~     phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care~     (fluoride dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F~     and dentifrice- 1,100 ppm F, NaF).~      During the 3-day phase, the appliance was only removed during the main meals (four times a~     day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals,~     before replacing the appliance in the mouth, the subjects were advised to perform oral~     hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and~     dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from~     Crest Procter & Gamble, Cincinnati, OH, USA) according to the phase and dental floss~     (Sanifill, São Paulo, Brazil).~      The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the~     first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of~     solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects~     were advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to~     Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before~     the in situ study for 6h and then removed.~      The enamel remineralization was quantified using transverse microradiography (% mineral~     recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were~     submitted to statistical analysis (p<0.05).~   "
32033|NCT02637817|"~     As a common white matter (WM) disease in preterm neonates, punctate white matter lesion~     (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual~     and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood.~     However, it is lack of certain methods in identifying the prognosis of PWML. Through using~     various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter~     longitudinal study would be conducted to follow-up the PWML neonates with varying~     spatial-position and degree lesions. Through tracking the variations in WM microstructures~     from neonate period to childhood (2 years old and 3 years old), this study aims to explore~     (1) the potential relations between varying PWMLs and motor and visual disorders (2) the~     relations between WM MRI-metrics and neurodevelopmental assessment results, and thus~     determine the early biomarkers to identify CP and amblyopia.~   "
32034|NCT02637804|"~     Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A~      This is a total 120 subject, randomized, open label, bilateral wear, two week crossover~     study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical~     lenses compared to narafilcon A or delefilcon A spherical lenses.~   "
32045|NCT02637661|"~     The purpose of this study is to explore the earlobe crease as a risk factor of acute~     myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to~     predict high risk patients with coronary heart disease.~   "
32175|NCT02635971|"~     This study aims to explore the efficacy and safety of intra- arterial infusion of~     gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen~     by the Fudan University Institutional Review Board which has Federal Wide Assurance through~     the U.S. Department of Health & Human Services (Approved: April 25, 2002).~   "
32194|NCT02635724|"~     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of~     600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza~     infection and in subjects with acute uncomplicated influenza infection at higher risk for~     influenza complications. All subjects will receive IV peramivir.~   "
32035|NCT02637791|"~     Stroke is the third most common cause of mortality and the leading cause of long term~     disability worldwide with over 900,000 people living in England who have had a stroke. 75%~     of survivors regain their ability to walk again, however it is estimated that between 55 and~     75% fail to regain satisfactory use of their impaired arm. This limits the person's~     independence, ability to care for themselves and reduces their quality of life. Research~     indicates that for optimal recovery, high levels of rehabilitation are required yet current~     provision often fails to meet the required levels of intensity and duration of therapy.~      In conjunction with stroke patients, their families and therapists, the team developed a low~     cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at~     home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers~     turning the hand into a game controller to play games that encourage the movements of reach,~     grasp and release that underlie activities of daily living.~      Before examining its effectiveness, the purpose of the registered study is to determine how~     feasible a large trial would be in terms of whether sufficient participants could be~     recruited, whether they would use the glove and whether outcome measures could be collected.~      Patients will be recruited if they are aged 18 years or over, are recovering from a stroke,~     no longer receive any other intensive rehabilitation but still experiencing difficulty using~     their arm. After baseline measures are collected they will be randomly allocated to either~     the intervention group or a control group. The intervention group will have the virtual~     glove and games at home for a period of eight weeks and be advised to use the equipment for~     20 minutes, three times a day. The control group will continue to have whatever care they~     are already receiving but no new interventions.~      Outcome measures will be collected at baseline, four weeks and after the equipment has been~     removed from their home. Outcome measures will include tests of arm function as well~     participant reports of how often they are using their affected arm and how easy they find~     activities of daily living. The therapists collecting the outcome measures will not know to~     which group the participants have been allocated.~      Once all outcome measures are collected the two groups will be compared on how much their~     final outcome measures differ from those collected at baseline.~   "
32036|NCT02637778|"~     The interventional study will evaluate effectiveness and potential of a 'cardioprotective~     diet' for adults with increased risk for cardiovascular diseases (CVD). The~     'cardioprotective diet' is characterized by adequate energy intake, intake of carbohydrates,~     protein and fat according to the guidelines of the German Society of Nutrition (DGE e. V.),~     with special focus on fat quality of the foods.~      Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g~     eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive~     defined personal nutritional counselling every two weeks and they get daily menu plans (with~     optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).~   "
32037|NCT02637765|"~     This is a prospective randomized controlled trial in which patients with previous breast~     cancer will be randomized into two treatment arms:~        1. Control Group of Usual Physical Activity~        2. Intervention Group of Increased Physical Activity~      No specific intervention will be performed In the patients randomized in the control group.~      Patients randomized in the Intervention group will receive a program of increased physical~     activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time~     patients of this group will receive an 8-week recreational program of brisk walking/running~     (3 times a week).~      All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit)~     able to count the number of steps, determine a daily goal of steps, determine the covered~     distance (in Km), determine daily caloric consumption, and determine the movements during~     sleep.~   "
32038|NCT02637752|"~     Background: Childhood obesity imposes a great burden on the healthcare system. Given the~     increased frequency of dental compared to medical visits during childhood, dentists may be~     in an ideal position to recognize patients at risk of developing obesity. This randomized~     clinical trial explored the efficacy of a brief nutrition and physical activity counseling~     for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic.~      Methods: 168 children, 6-11 year old, were allocated to test and control groups and their~     Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire~     regarding their child's nutrition, physical activity and screen time. The parents/caregivers~     of the test group then received a brief counseling session that encouraged an increase in~     children's physical activity, and a decrease in sugar-sweetened beverages and screen time.~     Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using~     general linear regression, adjusting for age, gender, socio-demographic characteristics,~     education, labour force, income and awareness of school nutrition policy (P≤ 0.05).~   "
32039|NCT02637739|"~     About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on~     first visit and are classified as pregnancy of unknown location (PUL). The etiology includes~     ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of~     ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C,~     and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to~     evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.~   "
32040|NCT02637726|"~     In children, only a few studies have compared different modes of propofol infusion during a~     total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is~     to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values)~     between four modes of propofol infusion: titration of the infusion rate on clinical signs~     (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion~     (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI~     SBIS).~      Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the~     anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate~     BIS values (45-55), the bias and imprecision will be calculated.~   "
32041|NCT02637713|"~     Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy.~     Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is~     an endoscopic FDA approved device that improves symptoms of GERD, there is minimal~     information about its use on patients after sleeve. This registry will attempt to get~     information regarding the treatment of reflux using Stretta after sleeve gastrectomy.~   "
32042|NCT02637700|"~     Small fiber neuropathy (SFN) is the most common cause of neuropathic pain in peripheral~     neuropathies, with a prevalence of at least 53/100.000. Patients with SFN may have~     excruciating pain and current anti-neuropathic and other pain drugs do not relief pain~     substantially.~      Several studies suggested an immunological basis in SFN and case studies have reported~     efficacy of treatment with intravenous immunoglobulin (IVIg) in patients with SFN. It is~     therefore conceivable that immunological mechanisms play a role in idiopathic SFN (I-SFN).~     However, to date no randomized controlled study with IVIg in patients with SFN has been~     performed. The aim of the current study is to investigate the efficacy and safety of IVIg in~     patients with I-SFN in a randomized, double-blind, placebo-controlled study.~      The objective of the study is to evaluate the efficacy of IVIg treatment (4 courses of~     treatment, 3 weeks apart) compared to placebo on pain alleviation.~   "
32046|NCT02637648|"~     The purpose of this study is to test the effects of sodium oxybate on headache response~     (frequency), sleep quality and quality of life in the prophylactic treatment of patients~     with chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting~     with 3g in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third~     night until treatment Response will be evaluated in an interventional, placebo-controlled,~     double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of~     nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective~     level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free~     episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S,~     CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).~   "
32047|NCT02637635|"~     The purpose of this study is to determine if autologous fat transplantation as a~     pre-treatment gives better results in breast reconstruction with implants after mastectomy~     and radiotherapy. One group is randomized to conventional reconstruction with implant and~     one to pre-treatment prior reconstruction with implant.~      Our aims are:~        1. To study whether lipofilling can decrease the number of reoperations and complications~          such as postoperative infections or not.~        2. Evaluate the aesthetic results and the patients' experiences. For both these aims the~          hypothesis is that pre-treatment is in favour for the outcomes.~   "
32048|NCT02637622|"~     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to~     clarify the principal benefit-risk factors FDA considers during the reviews for premarket~     approval applications and de novo classification requests. In addition to a detailed~     description of benefits and risks, CDRH listed patient tolerance for risk and perspective~     on benefit as a factor that CDRH may consider in regulatory reviews. It underlined the need~     for developing methods to measure patient preference and incorporate it into regulatory~     decision-making. The purpose of this study is to advance methods for patient and community~     engagement in patient-centered outcome research (PCOR) and has three objectives.~      First, demonstrate good practices for patient and community involvement in PCOR projects by~     applying principles of community-based participatory research (CBPR).~      Second, address methodological gaps pertaining to the use of stated-preference methods in~     studying preferences in PCOR. These include identifying the best methods for designing a~     preference study and strategies for analyzing variation in preferences. The investigators~     also seek to assess the relevance of stated-preference methods to patients and stakeholders~     using both qualitative and quantitative methods.~      Third, demonstrate good practices for applying stated-preference methods by studying the~     preferences of patients with type II diabetes. While type II diabetes provides an important~     case study, this research will advance approaches and methods that will be broadly~     generalizable to other diseases, and to diverse patient and stakeholder groups.~      Clinical Significance:~      This project will illustrate and advance methods for assessing the values of patients and~     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of~     stated-preference methods in measuring the preferences of patients and stakeholders and~     directing health care.~   "
32049|NCT02637609|"~     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to~     clarify the principal benefit-risk factors FDA considers during the reviews for premarket~     approval applications and de novo classification requests. In addition to a detailed~     description of benefits and risks, CDRH listed patient tolerance for risk and perspective~     on benefit as a factor that CDRH may consider in regulatory reviews. It underlined the need~     for developing methods to measure patient preference and incorporate it into regulatory~     decision-making. The purpose of this study is to advance methods for patient and community~     engagement in patient-centered outcome research (PCOR) and has three objectives.~      First, demonstrate good practices for patient and community involvement in PCOR projects by~     applying principles of community-based participatory research (CBPR).~      Second, address methodological gaps pertaining to the use of stated-preference methods in~     studying priorities in PCOR. These include identifying the best methods for identifying~     patient priorities and strategies for analyzing variation in priorities. The investigators~     also seek to assess the relevance of stated-preference methods to patients and stakeholders~     using both qualitative and quantitative methods.~      Third, demonstrate good practices for applying stated-preference methods by studying the~     priorities of patients with type II diabetes. While type II diabetes provides an important~     case study, this research will advance approaches and methods that will be broadly~     generalizable to other diseases, and to diverse patient and stakeholder groups.~      Clinical Significance:~      This project will illustrate and advance methods for assessing the values of patients and~     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of~     stated-preference methods in measuring the priorities of patients and stakeholders and~     directing health care.~   "
32050|NCT02637596|"~     A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients~     treated with intraoperative radiofrequency ablation (RFA).~   "
32051|NCT02637583|"~     The purpose of the present study is to compare the immunological response of pneumococcal~     serotype specific B-cells, the humoral immune response and safety after sequential~     vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine~     (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in~     a prospective, randomized controlled monocentric head-to head clinical study in elderly. The~     hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve~     an improved immune-response compared to sequential vaccination or single vaccination.~      Adults >=60 years without previous pneumococcal vaccination will be randomized in three~     groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination)~     or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they~     receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal~     serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and~     PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A)~     and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against~     the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all~     three groups. Adverse events will be recorded for 28 days after each vaccination.~   "
32052|NCT02637570|"~     This study evaluated effect of Hibiscus tea and green tea supplements on athletic~     performance, blood pressure, muscle damage indices and oxidative stress in male athletes~     18-35 years old and cardiovascular disease prevention approach.~   "
32053|NCT02637557|"~     The objectives of this study are to evaluate the safety, efficacy, and dose-response~     relationship of IW-3718 administered orally to patients who have GERD and continue to~     experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs~   "
32054|NCT02637544|"~     Aim of this randomized clinical trial is to examine the treatment effectiveness of an~     acupuncture protocol in adult patients with non chronified TMDs.~   "
32055|NCT02637531|"~     This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in~     subjects with advanced solid tumors.~   "
32121|NCT02636673|"~     Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic~     sigmoid resection for both benign and malignant disease~   "
32122|NCT02636660|"~     This study will allow us to determine the perceived Health-Related Quality of Life (HRQL) a~     year after ICU discharge, and compare it with HRQL measured earlier on in the process, as~     well as analyse the negative experiences they had while in the ICU and as a result of MV and~     their impact over time. It will also allow us to assess the effect of Nursing Sensitive~     Outcomes and ICU stressors on health-related outcomes and how they affect HRQL.~   "
32056|NCT02637518|"~     There is a proved strong evidence of the usefulness of frailty as a predictive factor of~     relevant and desired outcomes in populations of older adults. Several studies have been~     published showing the utility of the concept in improving the prognosis accuracy and the~     prediction of different risks (hospitalisations, surgical and non surgical complications,~     length of stay, death, incident disability, etc.) in emergency departments, surgical~     patients, and inpatients with cardiovascular disease. The studies have placed the focus in~     assessing population risk, while the validation process for these instruments as diagnosis~     or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as~     screening and diagnosis tools of some selected instruments to detect frailty in both~     clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing~     diagnostic algorithms clinically sound. Target groups are all of those older adults at risk~     of frailty (pre-frail) plus those that are frail and are at risk for developing disability.~     According to the published prevalence of these two conditions, the target population~     concerned by this project represents around 40-50% of people older than 65, and 60-70% of~     people older than 75. Once determining the best tools of screening and diagnosis in~     different settings of care, investigators will research conclusions of these people wherever~     the level of care they need and currently use. The benefit will spend to the Health System~     and Social Care as it will provide validated instruments that are necessary to provide an~     appropriate care for older adults by means of a comprehensive, continued, coordinated and~     integrated care.~   "
32057|NCT02637505|"~     114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee~     will be randomized to either receive arthroscopic microfracture or arthroscopic debridement.~     Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The~     groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated~     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical~     examination and radiological findings at 2 years (MRI).~   "
32058|NCT02637492|"~     Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial~     disease (POAD). Despite progress in the revascularization procedures, half these patients~     experience amputation or death after one year. One issue is to identify these subjects~     because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a~     patient with POAD but no rest lower limb ischaemia), revascularization will not be~     necessary. Then it would be useful to develop a simple score to help the physician to~     improve diagnosis of CLI.~   "
32059|NCT02637479|"~     80% of palliative care cancer patients suffer from severe pain. The management of these pain~     improves the quality of life of these patients. The management of opioid pain refractory to~     date remains a difficulty for caregivers. Hypophysectomy performed to try to control~     hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer.~     The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of~     patients. She would have the advantage of reducing the risk of complications compared to~     other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain~     associated with metastases on average in 2 days and would reduce or stop opiates most often~     responsible for side effects impairing the quality of life. The objective of this clinical~     trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of~     surgical hypophysialis radio for patients in palliative situations with refractory cancer~     pain in opioid level III. The type of pain cancer pain was done in order to optimize the~     recruitment and homogenization of the study population: patients cared for in palliative~     care units are mostly patients cancer (70-80%). This study is therefore part of a palliative~     setting and the results of this test can be extrapolated to other populations of palliative~     patients with refractory pain.~   "
32060|NCT02637466|"~     The purpose of this antidepressant study is to determine the efficacy of vortioxetine on~     depression and cognition in 80 women with breast cancer, and to elucidate~     inflammatory-mediated mechanisms by which depression and its treatment influence cancer~     outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed~     women with breast cancer will attenuate increased intermediate endpoints of inflammation~     that contribute to the pathogenesis of depression, cognitive impairment, and cancer~     progression~   "
32061|NCT02637453|"~     Pulmonary vein(PV) isolation has become the cornerstone of radiofrequency ablation for AF.~     However, recent reports have clearly shown that the longer the follow-up period, the lower~     the success rate with a single ablation procedure. In 5-year follow-up, the mean success~     rate was only about 45%. The purpose of the study to investigate whether the linear ablation~     perpendicular to the PV ostium on the basis of circumferential pulmonary vein isolation, can~     reduce recurrence rate of AF. All patients will be followed up for 12 months. And fourteen~     days Holter will be performed at the end of follow-up.~   "
32062|NCT02637440|"~     In patients with ST elevation myocardial infarction (STEMI) the treatment goal is~     revascularization of the occluded artery with the use of primary percutaneous coronary~     intervention (PCI). There is a large subset of patients with STEMI who also have significant~     disease in arteries other than the site of occlusion, and away from the culprit artery. It~     is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.~      The evidence on how to treat those patients with multi vessel disease is conflicting.~     Earlier large-scale studies and registries have suggested early and complete~     revascularization is of no benefit or even harmful. More recent studies have showed the~     opposite of that. The CVLPRIT study showed that early complete revascularization or~     preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial~     infarction and need for repeat revascularization. The benefit was mainly due to reduced~     repeat revascularization in the more intensive intervention group. The PRAMI study showed~     very similar results as well.~      The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also~     showed conflicting results so far. A previous trial showed that FFR guided intervention post~     STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided~     complete revascularization improved outcome when compared with more conservative treatment~     of ischaemia driven intervention.~      In this study, the investigators are going to assess the issue of staged revascularization~     guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven~     revascularization~   "
32063|NCT02637427|"~     The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in~     patients with moderately elevated international normalized ratios (INR) prior to undergoing~     an invasive procedure.~   "
32064|NCT02637414|"~     This protocol proposes a well-being program, delivered through an application for mobile~     devices, based on meditation and positive psychology principles such as human development,~     the improvement of virtues, quality of life and well-being. The investigators hypothesize~     that this program offered in mobile application may promote well-being and reduce stress~     related problems in the participants.~      Objectives: To evaluate the effectiveness of a well-being program delivered through an~     application for mobile devices in a sample of employees who work in a company (Natura~     Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).~      Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees~     from Hospital Israelita Albert Einstein will be recruited. The participants will be~     randomized in two groups of 125 participants each one, half of them in the control group~     (GC) and the other half to the intervention group (GI), by institution.~   "
32065|NCT02637401|"~     Bipolar Disorders (BD) typically involve repeated episodes of both depression and~     excessively high mood or irritability (hypomania or mania). BD presents considerable~     challenges for the individual, his or her supporters, and society more generally. Medication~     is generally considered to be the mainstay treatment, however a substantial number of~     individuals with BD continue to experience episodes despite use of medication. Furthermore,~     ongoing mood instability either outside of episodes, or as the main feature of their BD, is~     a significant difficulty experienced by many. Whilst studies suggest that certain~     psychological therapies can be helpful for people experiencing full bipolar episodes, or to~     reduce risk of future episodes, there are no evidencebased psychological therapies available~     for individuals experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT)~     was developed several decades ago as an approach for people with Borderline Personality~     Disorder. DBT aims to give individuals who experience rapid and intense shifts in affect~     skills for managing this. Despite the many similarities in the symptoms experienced by~     individuals with Borderline Personality Disorder and those with Bipolar Disorder only a~     small number of studies have tested DBT for BD, and no studies to date have specifically~     investigated DBT as a means to help individuals with ongoing mood instability. We have~     developed a version of groupbased DBT that draws upon our own research to adapt standard DBT~     for this client group (DBTBD).~      The group is designed to be delivered efficiently within the U.K. healthcare system whilst~     meeting the needs of individual participants through use of additional individual sessions~     and a mobile phone application. The current study investigates how acceptable DBTBD is to~     clinicians and patients, and whether - for the small number of individuals in the study~     -changes in symptoms and key ways of thinking and behaving appear to take place across the~     period of treatment.~   "
32066|NCT02637388|"~     The purpose of this study is to address the effect of consuming 4g of soluble fibre~     beta-glucan at breakfast on satiety and food intake.~   "
32067|NCT02637375|"~     Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms~     of breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy~     resistance), the study will test a novel approach for improving chemotherapy effectiveness~     by adding Hsp90 inhibition to antagonize the anti-apoptotic signaling pathways that are~     initiated via GR, AR, and JAK/STAT activation.~   "
32068|NCT02637362|"~     A randomised trial comparing three analgesic strategies for patients undergoing forefoot~     surgery in a day-surgery setting.~   "
32069|NCT02637349|"~     The POST's public health impact is likely to be substantial because it will improve cancer~     survivorship planning, which is currently an important deficiency in cancer care recognized~     by the Institute of Medicine and the American College of Surgeons.~      The POST may have many potential benefits for patients such as:~        1. improved long-term health outcomes;~        2. improved psychosocial outcomes and quality of life;~        3. smoother transitions back into old and new life roles; and~        4. improved continuity and coordination of care between providers.~      Most importantly, the POST's influence may reach beyond the patients it directly serves as~     it could help scientists and health care providers understand the potential benefits of~     cancer survivorship planning and how to best design and implement survivorship planning when~     patients are ending treatment for cancer.~   "
32070|NCT02637336|"~     The aim of this study was to evaluate the acute cardiovascular responses in hypertensive~     individuals, in waking and sleeping periods after application of different~     non-pharmacological therapies for the control of blood pressure (BP). Randomly and random~     volunteers held a session of each therapy: Acupuncture, aerobic exercise, essential oil~     inhalation, and session control with a minimum interval of 72 hours between them. On the day~     of sessions the volunteers did not use antihypertensive medication. The variables measured~     in the survey were the blood pressure and heart rate variability (HRV). Descriptive~     statistical averaging procedures, standard deviation and standard error of mean were~     adopted. Two-way ANOVA for repeated measures was performed post-hoc Tukey. The level of the~     study significance was set at p <0.05.~   "
32071|NCT02637323|"~     This is an open-label, single administration study of 40 mg of FX006 and Triamcinolone~     Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) conducted in~     male and female patients with Osteoarthritis (OA) of the knee.~   "
32072|NCT02637310|"~     A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical~     trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis~   "
32073|NCT02637297|"~     This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer~     survivors. Hypnotherapy is a state of concentration and focused attention which can provide~     more control over the experience of acute and chronic pain and its impact and may provide~     comfort, maximize function, and improve quality of life in cancer survivors.~   "
32074|NCT02637284|"~     Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of~     BPC-157, a pentadecapeptide from gastric source.~   "
32075|NCT02637271|"~     In order to better understand how commonly used dietary interventions for obesity influence~     brain activity and in turn people's ability to adhere to their healthy nutrition plan, the~     investigators need to study how people's brains react to food cues while undergoing such~     interventions. Our study will add to our understanding of neural (brain) regulation of~     hedonic and homeostatic mechanisms (i.e. pleasure and hunger) in influencing adherence to~     calorie-reduced eating plans.~   "
32123|NCT02636647|"~     Randomized, open-label safety, tolerability study with exploratory endpoints and~     pathophysiological evaluation of the FMT~      Two groups of outpatients with cirrhosis will be randomized using random sequence generator~     into no-treatment and FMT groups.~   "
32178|NCT02635932|"~     The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects~     the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to~     difficulty in manual function and decrease the patient's quality of life. Immobilization of~     TMC thumb joint by bracing has been effective in reducing pain and improving function.~     Objective: To compare the effectiveness between day and night functional splint for patients~     with trapeziometacarpal osteoarthritis in improving pain and function~   "
32076|NCT02637258|"~     This study is designed as a multicenter, prospective, cohort clinical study. The out of~     hospital cardiac arrest (OHCA) patients presenting to the adult emergency departments of the~     participating hospitals will render the study population. The non-traumatic,~     non-intracranial event related OHCA patients in whom the return of spontaneous circulation~     (ROSC) is achieved will render the sampling group.~      The primary aim of this study is to evaluate the relationship of bedside ultrasound (USG)~     measurements of Optic Nerve Sheath Diameter (ONSD) following the ROSC after Cardiopulmonary~     resuscitation (CPR) for OHCA patients, with early (3rd day) neurological evaluation and 30~     days survival rate, proposing that increased ONSD may be related to negative neurological~     outcomes. Considering a relationship is found, the secondary goals of the study are~     established as, identifying a cut-off value for ONSD related to negative neurological~     outcome and the optimal time to measure ONSD.~      The sampling size with a power of 95% is calculated to be 203 patients. The patients whose~     available next of kin has given consent will be admitted to the study.~   "
32077|NCT02637245|"~     Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients.~     While anti-VEGF treatments and to a lesser extent corticosteroid and macular~     photocoagulation have improved outcomes in patients with DME, no single therapy is~     universally effective and currently there is no a priori means of determine which patients~     will respond best to any given therapy. The purpose of this study is to determine whether~     specific parameters of ocular imaging studies including optical coherence tomography and~     fluorescein angiography can predict response to treatment in patients with DME. This is a~     prospective observational cohort study that will collect clinical data and imaging studies~     obtained as standard of care. Up to 150 subjects with clinically significant DME will be~     enrolled at Duke Eye Center or its satellite offices. These imaging studies will be analyzed~     to determine whether specific parameters are associated with poor or favorable response to~     specific treatments. There will be no intervention as part of this observational trial, thus~     the primary risk to subjects is loss of confidentiality, which will be minimized by the~     study team.~   "
32078|NCT02637232|"~     The aim of the study is to evaluate the level of satisfaction among patients to whom~     Mirvaso® / Onreltea TM (trade mark) is prescribed.~   "
32079|NCT02637219|"~     The purpose of this study is to determine whether the response of the immune system to~     bacterial components differs between patients with severe COPD compared to those with less~     severe COPD.~   "
32080|NCT02637206|"~     GSK2894512 is a novel anti-inflammatory agent that is currently under development for the~     topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a~     Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists~     of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a~     single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by~     simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy~     Japanese volunteers. Part 2 of this study will assess skin irritation following repeat~     application at 0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive~     condition in 6 healthy Japanese volunteers. The study will have Screening visit which will~     occur within 30 days from the Day 1 visit of each part. Eligible subjects will be able to~     participate either of Part 1 or Part 2. Subjects will visit the site on Day -1, and~     hospitalized until the end of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects~     will re-visit the site on Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This~     study will be the first to evaluate the safety, tolerability and pharmacokinetics of~     GSK2894512 cream after single and repeat application in Japanese subjects. Results from this~     study will enable further clinical investigation in the Japanese population.~   "
32081|NCT02637193|"~     The purpose of this study is to demonstrate a lack of effect of venlafaxine (Effexor XR) on~     QTc intervals relative to time matched placebo in healthy volunteers~   "
32082|NCT02637180|"~     This is multiple center, prospective study aiming to investigate the tracking and outcome of~     patients attending Greek General hospitals with low-trauma fractures. Secondary end-points~     were to facilitate the implementation of coordinated, multi-disciplinary models of care for~     secondary fracture prevention, and to monitor osteoporosis treatment initiation,~     osteoporosis treatment persistence at 12 months, compliance, and subsequent fractures.~   "
32083|NCT02637167|"~     The objective of this trial is to study the effect of targeting the gut microbiota in~     patients with heart failure (HF). First, the investigators will characterize gut microbiota~     composition in patients with various degree of systolic HF as compared with healthy~     controls. Second, the potential impact of targeting gut microbiota to improve HF will be~     investigated through an open label randomized controlled trial (RCT) of probiotics,~     antibiotics and controls. The hypothesis being tested is that the gut microbiota is altered~     in HF; that gut microbiota of HF patients, through interaction with the intestinal and~     systemic innate immune system, contribute to a low-grade systemic inflammation as well as~     metabolic disturbances in these patients; and that an intervention with probiotics and the~     non-absorbable antibiotic Rifaximin attenuates these inflammatory and metabolic disturbances~     and improves heart function through modulation of the gut microbiota.~   "
32084|NCT02637154|"~     This study investigates the effect of motivational interviewing and intensive education on~     HbA1c values and glucose variability in poorly controlled adolescent T1D patients.~      In the present study motivational interviewing (MI) will be integrated to clinicians' daily~     practice, as a part of normal clinical visit. In this randomized, controlled trial~     hypothesis is, that applying motivational interviewing during regular clinical visits~     results in better acceptance and subsequently enhanced metabolic control in adolescents with~     poorly controlled type 1 diabetes.~   "
32085|NCT02637141|"~     Protocol CELIM-NRCD-001 is designed to be a Phase 2a, randomized, double-blind,~     placebo-controlled, parallel-group study to evaluate the efficacy and safety of AMG 714 for~     the attenuation of the effects of gluten exposure in adult patients with celiac disease~     during a gluten challenge.~   "
32086|NCT02637128|"~     This study was designed to determine the efficacy of both artemether-lumefantrine and~     artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the~     treatment of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and~     Karonga District Hospitals- Malawi.~   "
45982|NCT02455141|"~     To compare disease-free survival (DFS) rate of adjuvant chemotherapy~     epirubicin-cyclophosphamide followed by weekly paclitaxel (EC-wP), or weekly~     paclitaxel-carboplatin (EC-wPCb) in triple-negative breast cancer.~   "
32087|NCT02637115|"~     Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity~     are characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin~     resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation)~     representing a major public health problem. Therefore, it is urgent to find a therapeutic~     solution to target all these metabolic disorders. Among the environmental factors able to~     influence the individual susceptibility to gain weight and to develop metabolic disorders~     associated with obesity, more and more evidence show that the trillions of bacteria housed~     in our gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The~     investigators recently discovered a putative interesting microbial candidate, namely~     Akkermansia muciniphila (Akk). More exactly, we found that the administration of Akkermansia~     muciniphila reduced body weight gain, fat mass gain, glycemia and inflammatory markers in~     diet-induced obese mice. Moreover, in overweight/obese patients with cardiovascular risk~     factors subjected to a calorie restriction diet (calorie restriction diet for 6 weeks and an~     additional 6 weeks of weight maintenance), a higher abundance of Akkermansia muciniphila was~     associated with a better cardio-metabolic status in these patients. The investigators also~     discovered that patients having more Akkermansia muciniphila in their gut before the calorie~     restriction exhibited a greater improvement in glucose homoeostasis, blood lipids and body~     composition after calorie restriction. These observations suggested that the administration~     of Akkermansia muciniphila in overweight or obese people could be a very interesting~     therapeutic solution. Currently, no human study has investigated the beneficial effects of~     Akkermansia muciniphila administration on obesity and metabolic disorders. The overall~     objective of this study is to evaluate the effects associated with the administration of~     live or heat-killed Akkermansia muciniphila on the metabolic disorders (insulin-resistance,~     type-2 diabetes, dyslipidemia, inflammation) related to overweight and obesity in humans.~   "
32088|NCT02637102|"~     CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular~     surgery assess and manage patients in different ways before surgery. Some centres have~     introduced the use of intravenous iron therapy for patients with anaemia in the preoperative~     setting. Consequently regional variation exists in the assessment and management of patients~     before cardiac and vascular surgery. We aim to observe and measure these differing pathways~     and observe if there is variation in iron deficiency and anaemia and the impact of these~     variables on patient cardiorespiratory function as well as post-operative outcomes.~      [Sub-Study] For patients who are receiving intravenous iron therapy as part of their routine~     clinical care, we wish to observe this effect in more detail. We will assess the impact of~     the treatment on well-being, blood count and fitness. Information will be collected through~     Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and~     fitness testing.~   "
32089|NCT02637089|"~     Parkinson's disease (PD) is known for its motor symptoms and affects more than 100,000~     Canadians. However, PD patients also show cognitive deficits and neuropsychiatric problems~     that significantly impair their quality of life. The occurrence of dementia in PD is much~     higher than in the general population. The proposed study will allow the principal~     investigator, his team and his collaborators to investigate the origins and evolution of the~     cognitive and neuropsychiatric symptoms. Participants with PD with and without mild~     cognitive impairment (MCI) and participants with and without MCI over the age of 60 years~     will be assessed during eight study visits over three years. Through brain imaging, clinical~     testing, as well as genotyping the cognitive patterns in the four different groups will be~     observed and compared. The results will be used to identify biomarkers that can predict the~     occurrence of dementia early in the disease. Ultimately, the results of the proposed~     research will contribute to interventions and treatment strategies tailored to different~     cognitive profiles in PD before the occurrence of dementia.~   "
32090|NCT02637076|"~     The overall aim is to establish whether the drug Xyrem® has an action on the brain dopamine~     system in patients with narcolepsy.~      Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve~     narcolepsy with cataplexy patients, whether a single dose of Xyrem® causes changes in~     striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered activity of brain~     dopamine neurones.~   "
32091|NCT02637063|"~     This project will develop and evaluate an interactive blood pressure self-management program~     for adults with prehypertension. The program will target blood pressure self-monitoring and~     the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary~     Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and~     alcohol consumption.~      The multi-modal program uses a combination of brief motivational health coaching, periodic~     engagement emails, and a robust interactive website to motivate people to take charge of~     their blood pressure management before they require medication. All program components were~     designed to conform to the underlying principles of motivational interviewing. Key program~     components include the use of email and Web-based social networking, personal stories, and a~     brief motivational coaching session to engage participants and encourage intrinsically~     motivated behavior changes. Self-assessment and tracking tools are combined with educational~     content to help participants align their daily lifestyle choices with their personal goals.~      The Phase I prototype program promoted moderate physical activity and eating fruits and~     vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation~     showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation~     behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in~     physical activity. Participants gave the online program high ratings on satisfaction and~     usability, and reported improvements in confidence, readiness, clarity, change strategies,~     and interest in visiting the Website as a result of the coaching session.~      The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)~     with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month~     follow-up period. The Phase II trial is expected to show reductions in blood pressure and~     improvements in JNC-recommended health behaviors. These changes in the outcome measures are~     expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral~     intention, motivation, and patient activation.~   "
32092|NCT02637050|"~     The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic~     Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.~   "
32093|NCT02637037|"~     This is a bioequivalence study to compare 2 fixed-dose combination tablets of~     dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under~     fasting and fed conditions~   "
32094|NCT02637024|"~     This is a multi-centre randomized phase II trial in women with invasive carcinoma of the~     breast with negative axillary nodes or Ductal Carcinoma In-situ (DCIS) treated by Breast~     Conserving Surgery (BCS). Eligible, consenting patients will be randomly allocated to~     receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated~     Partial Breast Irradiation (APBI) 30 Gray (Gy) in 5 daily fractions of 6Gy or 27.5Gy in 5~     daily fractions of 5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60~     months post randomization. Cosmetic outcome will be measured using photographs and evaluated~     by a panel of trained radiation oncologists. Radiation toxicity will be assessed using~     National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).~   "
32124|NCT02636634|"~     The purpose of this multicenter study is to assess a diagnostic strategy concerning~     differential diagnosis between radiation necrosis and relapse in brain metastases treated~     with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with~     1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared~     to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical~     treatment.~      The results of this study should help to earlier diagnosis of recurrences after radiosurgery~     and to perform an appropriate treatment for patients.~   "
32095|NCT02637011|"~     The purpose of the DACAPO study (Surviving ARDS: the influence of quality of care and~     individual patient characteristics on quality of life) is to investigate the role of~     quality of care and individual patient characteristics on quality of life and return to work~     in survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher~     quality of care is associated with better health-related quality of life and a higher rate~     of return to work among survivors.~      A prospective, observational, multi-centre patient cohort study is performed in Germany,~     using hospitals from the ARDS Network Germany as the main recruiting centres. It is~     envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population~     of 1500 survivors. They will be followed up until 12 months after discharge from hospital.~     Quality of care will be assessed as process quality, structural quality and volume at the~     institutional level. The main outcomes (health related quality of life and return to work)~     will be gathered by self-report questionnaires. Further data assessment includes general~     medical and ARDS-related characteristics of patients as well as sociodemographic and~     psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the~     effects of quality of care and individual patient characteristics on outcomes, taking the~     cluster structure of the data into account.~   "
32096|NCT02636998|"~     This study is designed to evaluate cognitive function in preadolescents who have different~     body mass indexes.~   "
32097|NCT02636985|"~     Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a~     mainstream tool for ultrasound-based diagnosis. This compressibility property of materials,~     mathematically expressed as the change in tissue displacement as a function of its distance~     from the compressing device, is known as strain and is the parameter that is imaged in an~     elastogram.~      Elastography has currently shown promising result in differentiating viscoelastic nature of~     various organs, which is a consequence of certain underlying diseases.~      At present, there are limited literatures revealing the application and feasibility of~     ultrasonic elastography in lung lesions. This is essentially important as it may serve as an~     adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and~     feasibility of ultrasonic elastography on lung lesions.~   "
32098|NCT02636972|"~     This is a cross-sectional observational study.~      For participants resident in Adelaide, South Australia.~      The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within~     the Royal Adelaide Hospital (RAH).~      A total of 56 participants will be recruited for this study.~   "
32099|NCT02636959|"~     Chronic sinusitis (CRS) is a common inflammatory sinus condition among Canadians. Saline~     irrigation is an effective therapy used in the management of CRS and is a commonly~     prescribed treatment in preoperative surgery for people with this condition. Recently, a~     study performed by a Toronto group in Canada tried to show if there is any significant~     improvement between using high versus low volume saline irrigation to treat CRS. Despite~     finding a trend, the number of people with CRS used in this pilot study was not large enough~     to conclusively declare any difference between the two treatment groups.~      PURPOSE: The purpose of this study is to determine if there is a clinical benefit of high~     volume saline nasal irrigation (HVSI) over low volume saline irrigation (LVSI) in the~     postoperative period in patients with chronic Rhinosinusitis (CRS). This study is part of a~     multicenter collaborative project initiated by Macdonald et al. (20). A sample size of 176~     participants (88 in each condition) is required to achieve data significance. To achieve~     this, our role is to collect data (plus those of four other Canadian rhinology research~     centres) from 20 patients and add our findings to theirs to establish an acceptable and~     significant result. This information would help otolaryngologists, family physicians, and~     other health care professionals recommend the best post-operative SNI (saline nasal~     irrigation) device for their patients with CRS.~   "
32100|NCT02636946|"~     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost~     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or~     ocular hypertension who are not adequately managed with topical IOP-lowering medication.~   "
32101|NCT02636933|"~     The PRE-AR project is a longitudinal observational study. The primary objective is the~     assessment of lung function parameters in late preterm preschool children.~   "
32102|NCT02636920|"~     It is an interventional prospective study. The study will assess the intervention of the~     Therapeutic Education to the Patient (TEP) on the quality of life in asthmatic children.~      The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 in the~     outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease~     Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM)~     of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.~   "
32103|NCT02636907|"~     This is an open-label, phase II study of BI 695501 to assess handling experience of patients~     with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients~     with additional exposure to BI 695501 and to enhance the safety database for this compound.~   "
32104|NCT02636894|"~     Filler study for smile lines in cheek folds~   "
32105|NCT02636881|"~     82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be~     randomized to either receive autologous cartilage implantation or arthroscopic debridement.~     Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The~     Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated~     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5~     dimensions) as well as clinical examination and radiological findings at 2 years (MRI).~   "
32106|NCT02636868|"~     The primary objective of this study is to evaluate the safety and efficacy of lucinactant~     for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32~     weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP)~     for Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.~   "
32136|NCT02636478|"~     One questionnaire has been configured to ask therapy naive and treated patients about their~     travel activities. Travel activities include private and professional traveling. Another~     questionnaire collects medical information.~   "
32137|NCT02636465|"~     The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2)~     with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under~     flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic~     chamber test.~   "
32107|NCT02636855|"~     This screening study is intended for men and women at least 18 years of age who have~     advanced solid or hematologic malignancy. The study will assess a subject's tumor antigen~     expression profile and HLA subtype. Based on the results, it will be determined if a subject~     can then enroll into an Adaptimmune-sponsored clinical trial which will test the safety of~     genetically changed T cells and find out what effects, if any, they have in subjects with~     solid or hematologic malignancies. No treatment intervention will occur as part of this~     screening study.~      Upon enrollment, subjects will provide a blood sample for testing. The blood sample will be~     sent to a central laboratory and tested for HLA subtype. If the results of the analysis~     match the HLA-A and/or HLA-B subtypes noted in the inclusion criteria, the subject will be~     required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The~     tumor sample will be screened at a central laboratory to test for tumor biomarkers (protein~     or RNA), which may include, but are not limited to NY-ESO-1 and/or LAGE-1a, MAGE-A10, and~     others to be determined.~      Following screening for eligibility into a clinical trial(s), tumor samples will be kept by~     Adaptimmune for the purpose of developing and validating a diagnostic assay(s) for antigen~     expression profiling.~   "
32108|NCT02636842|"~     The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole~     lauroxil in adults with schizophrenia or schizoaffective disorder.~   "
32109|NCT02636829|"~     The main objective of this study is to measure, in patients with MS or Chronic Inflammatory~     Arthritis (CIA), the correlation between two calcium intake assessment methods: A self~     assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a~     reference (gold standard) and based on data from CIQUAL *.~      * CIQUAL Data: Nutritional food composition table available on the website of the ANSES~     (National Agency for Sanitary Security of Food, Environment and Labour), published by the~     Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58~     nutritional components. The data is integrated into the software (DATAMEAL) for calculating~     the ingesta parameters at the Nîmes University Hospital.~   "
32110|NCT02636816|"~     The investigators are investigating whether slow administration of carbetocin is tolerated~     by patients better than if it is administered quickly, with respect to side effects such as~     headache, nausea, vomiting and facial flushing.~   "
32111|NCT02636803|"~     The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris~     trichiura at different doses in comparison to the standard single 400 mg dose of~     albendazole. In addition, the study will provide data on oxfendazole efficacy against other~     common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides,~     Ancylostoma duodenalis, Necator americanus).~   "
32112|NCT02636790|"~     The sinus surgical wait list in British Columbia continues to grow. The current wait list is~     beyond what is acceptable by the province's standard; however, this is not likely to improve~     given the budget constraints of the health care system. The outcome of having patients to~     wait longer than medically reasonable for surgery, not only affects the patients' quality of~     life but presents financial difficulties, both directly to the patient, the healthcare~     system and the economy as a whole. Therefore, the investigators need to determine which~     patients need to be prioritized for surgery. The investigators will follow two groups of~     patients - one group from Stanford University who get surgery always before 8 weeks and~     compare them to patients on the VGH wait list which is often more than one year.~   "
32113|NCT02636777|"~     Supported self-management (SM) is one of the key recommendations in management of chronic~     low back pain (CLBP). SM programmes for patients with CLBP have failed to show clinically~     meaningful improvement in pain and disability markers, which potentially reflect the lack of~     treatment matching of SM programmes. Patient selection for a SM programme for patients with~     CLBP is particularly difficult due to lack of extensive research on what predicts SM and its~     change. The overarching purpose of this study is to identify predictors of SM and its change~     over time in patients with CLBP. This study is a prospective non-experimental longitudinal~     study.~   "
32114|NCT02636764|"~     Osteoarthritis is a chronic, multifactorial characterization, which changes in bone~     alignment, cartilage and structures that provide joint stability appear to be strongly~     correlated with the origin of this disease.This project will aim to verify the effectiveness~     of interferential current, short wave and low level laser therapy on an exercise program for~     mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups:~     exercise group, exercise group + Ultrasound therapy, exercise group + interferential~     current, exercise group + short-wave diathermy, exercise group + Low level laser therapy.~     Before and after the trial protocol by the following instruments: Western Ontario and~     McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment~     (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of~     life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical~     rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal~     and electrical agents in an exercise program will provide an improvement in pain, mobility~     and knee function in individuals diagnosed with knee osteoarthritis.~   "
32115|NCT02636751|"~     This pilot single blind randomized controlled trial aims therefore to evaluate the~     feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation~     program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person~     prehabilitation or to usual care.~   "
32116|NCT02636738|"~     Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days~     follow up for evaluate the safety and utility of VelaTM XL thulium laser.~   "
32117|NCT02636725|"~     The investigators hypothesize that combination axitinib with pembrolizumab will improve~     progression-free survival relative to historical controls.~   "
32118|NCT02636712|"~     To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese~     subjects~   "
32119|NCT02636699|"~     The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein~     to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age~     after a 12-month treatment by epicutaneous immunotherapy (EPIT).~   "
32120|NCT02636686|"~     This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who~     previously have been treated with drisapersen, aiming at assessing the safety and efficacy~     of drisapersen.~   "
32125|NCT02636621|"~     Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized~     by airway resistance to breathing during sleep that leads to arousals and daytime~     sleepiness. There are few studies about UARS treatment and there is not any gold standard~     treatment for it yet.~      Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in~     patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in~     patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic~     nervous system.~      Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and~     Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep~     time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue)~     of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of~     age will be included. Subjects will be randomly distributed in OA group and placebo (without~     treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to~     sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography,~     Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive~     testing, autonomic nervous system analysis (heart rate variability) and metabolic~     evaluation. Mean and standard deviation will be used for descriptive statistical analysis if~     normal distribution, and median and percentiles (25%, 75%) for variables not normally~     distributed. To compare treatment groups T test (parametric) and Mann Whitney (non~     parametric) will be used. For adjusted analysis, linear regression analysis will be used.~   "
32126|NCT02636608|"~     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) and work productivity data of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis~     C virus infected participants.~   "
32127|NCT02636595|"~     The purpose of this study is to evaluate the effect of response to treatment by evaluating~     the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12~     weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in~     participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.~   "
32128|NCT02636582|"~     This randomized phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or~     sargramostim works in treating patients with breast cancer. Vaccines made from peptide or~     antigen and/or a person's white blood cells mixed with tumor proteins may help the body~     build an effective immune response to kill tumor cells that express breast cancer. It is not~     yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in~     treating patients with breast cancer.~   "
32129|NCT02636569|"~     This research study will test how well two topical medications work to prevent the~     development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This~     study is also looking at the optimal dose of a medication in a small number of people.~     Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are~     associated with specific diseases such as skin cancer. In this study, two topical~     medications will be evaluated; diclofenac and alpha-difluoromethylornithine (DFMO).~      Diclofenac and DFMO are approved by the Food and Drug Administration (FDA) for other uses.~     24 patients will be enrolled in this study by UAB.~   "
32130|NCT02636556|"~     This study is designed to evaluate the feasibility and safety of concurrent~     chemoradiotherapy for locally advanced thymoma or thymic carcinoma.~   "
32131|NCT02636543|"~     The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of~     information to the relatives after genetic diagnosis of a serious condition. This decree~     includes a specific model of letter that can be sent to relatives by genetic professionals.~     We evaluated the understanding and feelings after the reading of the decree's letter (letter~     A) on patients and the public. A focus group drafted a new version of the letter (letter B)~     through these observations. The two letter models (A vs B) are compared in terms of impact~     through precise items (understanding and feelings) on three populations: patients, public~     and genetic professionals. Assumption is made that the letter B will be preferred to the~     letter A. Overall, we aim at giving a letter formulation accommodating as many people as~     possible to standardize practices.~   "
32132|NCT02636530|"~     Bone responds according to the load placed on it. In this study, investigators want to know~     if exercise that loads the body in exercises, like walking or jogging (Ground Reaction~     Forces: GRF), affects bone differently than exercises that load the joints, like weight~     lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for~     6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be~     taken at the beginning and the end of the 6 month program. Period blood samples will be~     taken for future analysis of blood markers.~   "
32133|NCT02636517|"~     Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or~     without Inflammatory Bowel Disease (IBD)~      The aims of this study are to determine the safety and efficacy of FMT treatment in~     pediatric patients with recurrent or moderate to severe C. Difficile without (through an~     observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to~     determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing~     before and after transplantation in these patients.~   "
32134|NCT02636504|"~     The objectives of this study are to determine the sensitivity, specificity, positive~     predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in~     determining the vitality of teeth and comparing with those of electric pulp testing and cold~     testing.~   "
32135|NCT02636491|"~     Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and~     efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery~     system compared to sensor augmented pump therapy at patients with type 1 diabetes at home~     Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose~     sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours~     blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at~     patient's home.~      The duration of study participation for one subject is 28-56 days and the overall duration~     of the study is 6 months The participants of the study are patients ≥ 10 years until 65~     years with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose~     sensors.~      Sample Size n = 45~   "
32140|NCT02636426|"~     Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for~     tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical~     practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In~     this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a~     high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined~     in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve).~     Exposure escalation cohorts are used instead of conventional dose escalation cohorts because~     the effect of a drug is dependent of its AUC levels and large differences in plasma~     sorafenib AUC0-12h have previously been shown between patients treated at the same dose~     level. Using pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target~     plasma AUC0-12h. The escalation cohorts consist of 3-6 patients per exposure level starting~     with a target plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of~     the maximum tolerated AUC0-12h, 10 additional patients will be entered into an expansion~     cohort. In the expansion cohort the patients will be treated with a weekly pulse of~     sorafenib at the maximum tolerated AUC0-12h for further assessment of safety and preliminary~     exploration of efficacy.~   "
32141|NCT02636413|"~     The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking~     and on patient management, and its reproducibility (Test-Retest), for the diagnosis of~     hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose~     intolerance.~   "
32142|NCT02636400|"~     Is postoperative IUI better than expectant management in infertile endometriosis patients~     with good prognosis based on their EFI score? (A single centre randomised controlled trial).~   "
32143|NCT02636387|"~     This study assesses if using the medication desmopressin will decrease nightime bedwetting~     in children with sickle cell disease. Half of the children will receive placebo and half of~     the children will receive desmopressin, with the option to prescribe desmopressin as soon as~     the study is completed.~   "
32144|NCT02636374|"~     The purpose of this study is to examine the effects of a guided imagery intervention on~     perceived stress in pregnant adolescents.~   "
32145|NCT02636361|"~     This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the~     different formulations of LY900014. This study will determine how the different~     formulations, when injected under the skin, will affect the blood sugar levels in the body,~     and how safe it is.~   "
32146|NCT02636348|"~     The primary objective of this randomized, double-blind, placebo-controlled trial is to~     determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily~     throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength~     in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in~     PTH and result in greater increases in indices of bone strength compared to placebo.~   "
32147|NCT02636335|"~     The purpose of this study is to determine if an exposure to light in the morning has a~     positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight~     and obese patients.~   "
32148|NCT02636322|"~     The goal of this clinical research study is to learn if the combination of rituximab,~     lenalidomide, and ibrutinib, when given alone and with standard chemotherapy (called either~     EPOCH - Etoposide, Prednisone, Oncovin [vincristine], Cyclophosphamide, and~     Hydroxydaunorubicin [doxorubicin]; or R-CHOP - Rituximab, Cyclophosphamide,~     Hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], and Prednisone), can help to~     control diffuse large B cell lymphoma. The safety of this drug combination will also be~     studied.~   "
32149|NCT02636309|"~     BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work~     Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases~     might need an additional rehabilitation program.~      OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.~      METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to~     determine the efficacy of a multifaceted program, including ergonomics, exercise program and~     acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a~     hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning~     absenteeism, quality of life and work ability helped to evaluate the program that lasts one~     year and ten months.~   "
32150|NCT02636296|"~     The purpose of the present study was to investigate the effects of 12-week Pilates-inspired~     exercise on functional performance in community-dwelling older women.~   "
32151|NCT02636283|"~     This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain~     free walking duration on patients with peripheral arterial disease, a condition caused by~     decreased blood flow to the muscles in the legs.~   "
32152|NCT02636270|"~     With this study we want to investigate the pharmacokinetic (PK) effect of a single injection~     of rhIGF-1 in patients with PAPP-A2 mutations compared to heterozygous carriers and healthy~     controls. This will be followed by treatment of PAPP-A2 deficient patients with IGF-1 for a~     period of one year to assess growth velocity. Additionally we want to further describe the~     phenotypic characteristics of patients with PAPP-A2 deficiency.~   "
32153|NCT02636257|"~     To compare the clinical effects between the silicone nasolacrimal intubation under~     nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.~   "
32154|NCT02636244|"~     The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied~     topically to adult patients with alopecia areata of the scalp.~   "
32155|NCT02636231|"~     The purpose of this study is to determine whether endostar and IMRT is effective in the~     treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.~   "
32176|NCT02635958|"~     With, one in three Americans now having a body mass index (BMI) greater than 30, and the~     fastest growing segment of the population having a BMI greater than 40, it is paramount to~     conduct validation of approaches to measure body composition. Currently the dual-energy~     x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it~     is often difficult to perform since it is limited to specific height, weight and BMI's.~     InBody is a tool which uses bio electric impedance to measure the body composition. This~     study will compare both approaches. Validation is necessary as it is clinically quite~     pertinent to accurately assess a patients' body fat percentage, fat free mass, and total~     body water and changes that are occurring with nutritional support.~   "
32156|NCT02636218|"~     Subarachnoid hemorrhage (SAH) or bleeding in the brain as a result of ruptured aneurysm is a~     devastating type of stroke. Many patients who undergo emergent neurosurgery to repair the~     aneurysm and remove the bleeding suffer from complications in their subsequent hospital~     stay, the most frequent and morbid of which is delayed cerebral ischemia (DCI) or small~     strokes resulting from impaired blood flow to certain vital brain centers. This occurs~     because of changes to the brain's blood vessels that occur after the bleed. The arteries can~     become narrow (spasm) or small clots can form within the vasculature that disrupts normal~     blood flow. Patients are left with profound neurologic deficits from these secondary~     complications.~      Anesthesiologists, neurosurgeons, and intensivists are in need of a way to protect the brain~     during this vulnerable period following aneurysm repair. One drug that may provide such~     protection is ketamine, a compound frequently used in operating rooms and intensive care~     units to provide anesthesia and analgesia. Ketamine works by blocking glutamate receptor ion~     channels that play a pivotal role in promoting brain cell death during strokes by flooding~     the brain with too much calcium and dangerous chemicals. This project is designed to test~     the efficacy of ketamine in protecting the brain following aneurysm repair by using a~     controlled infusion of the drug in the intensive care unit (ICU) when patients return from~     their operation.~   "
32157|NCT02636205|"~     The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy~     for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that~     supports the weight of the child's arm and uses joystick that helps to play computer games.~     The child will be assessed before and after this therapy. Participating children with upper~     extremity impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions~     at progressively increasing degrees of difficulty. Each child's performance will be tracked~     with regard to time necessary to complete a predetermined number of trials of the activity.~     The standardized assessment tools that will be used are the Assisting Hand Assessment (AHA),~     Box & Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of~     Disability Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine~     the efficacy of this training method.~   "
32158|NCT02636192|"~     The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among~     participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure~     propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i)~     versus new use of various other antihyperglycemic agents (AHAs), combined as one group.~   "
32159|NCT02636179|"~     Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result~     of fertility decline likely caused by changes in both environment and social behaviour.~     Considering this large usage, it is important to evaluate the potential risk on the health~     of children conceived using ART.~      According to the literature, children born after ART are more likely to be at higher risk of~     health problems than spontaneously conceived ones. Interestingly, recent studies suggested~     an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).~      The purpose of this study is to evaluate the prevalence of asthma in school adolescents from~     a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared~     to a control group composed of the same age range spontaneously conceived individuals.~      The expected outcome of this study will provide new information regarding these children to~     ART professionals of and to their own families, by focusing on an age range (between 11 and~     15 years) for which very little information is available to date.~   "
32160|NCT02636166|"~     Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre~     and provide a sample of urine from the same void for further testing.~      Volunteers will then complete a product usage questionnaire and leaflet comprehension~     questionnaire at site.~      Follow-up information will be required from all volunteers as both additional urine~     sample(s) and pregnancy information to establish true pregnancy status at the study visit.~   "
32161|NCT02636153|"~     The purpose of this study is to investigate the effects of normal diet and low-phosphate~     diet on the level and the circadian pattern of serum phosphate concentration in normal~     subjects and to explore the underlying mechanisms.~   "
32162|NCT02636140|"~     This study will examine the effects of different colors of light on pupil function and~     alertness.~   "
32163|NCT02636127|"~     Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular~     damage, cutaneous and visceral fibrosis and a dysimmune condition.~      Therapies in this disease remain insufficient and the complications resulting from organs~     involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a~     strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved~     in the vascular damage of the SSc. However mechanisms at the onset of this endothelial~     cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue~     remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound~     adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune~     populations. The purpose of the project is to define the role displayed by cytotoxic,~     circulating immune populations of SSc patients in endothelial cytotoxicity as well as the~     role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune~     cytotoxic cells and the endothelium.~   "
32177|NCT02635945|"~     This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic~     subjects, following the supportive data from the proof-of-concept trial on the effect of~     PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). The purpose of the~     present study is to provide an assessment on the efficacy of a 5-day treatment course of~     once daily, orally administered, 10-mg PBF-680 doses, to attenuate Late Asthmatic~     Responses (LAR) as a primary efficacy outcome. The study also aims at analyzing the effect~     of the PBF-680 treatment course on airway inflammation-related outcomes including airway~     hyperresponsiveness to AMP at 24 h after allergen bronchoprovocation, plus nitric oxide~     fraction in exhaled air (FeNO) and airway inflammatory cells counts in induced sputum under~     the effect of an additional 10-mg PBF-680 dose on the 6th treatment period day. Overall, the~     study aims at providing evidence on the efficacy of PBF-680 on outcomes, particularly the~     LAR, that are well established to screen valid drugs for asthma maintenance therapy.~   "
32192|NCT02635750|"~     Part I:~      To investigate whether and to what extent donepezil affects single dose pharmacokinetics of~     BI 409306~      Part II:~      To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics~     of donepezil~   "
32164|NCT02636114|"~     ABSTRACT:-~      Introduction:~      Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious~     disease resulting in inflammation within of the tissues supporting the teeth, progressive~     loss of attachment and bone loss. It is closely related to several systemic diseases, such~     as diabetes and cardiovascular disease. The link between periodontal disease and chronic~     kidney disease (CKD) may be due to infection and inflammation. The periodontal inflammatory~     state may increases the chronic inflammation present in CKD, thus decreasing renal function.~     Periodontal therapy may reduce inflammation and improves endothelial function.~      Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum~     renal function markers in systematically healthy CP subjects.~      Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal~     function markers such as urea, creatinine, bilurubin in systematically healthy CP patient~     and to compare the clinical parameters such as Gingival index (GI), Plaque index (PI),~     Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test~     group (TG) & control group (CG).~      Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected.~     Categorized equally into group I and groups II. Group I was test group (TG) included 25~     patients and group II was control group (CG) included 26 patients. The serum levels of renal~     function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test~     group only. All the parameters were checked at baseline and one month after SRP. Comparisons~     of baseline and value after 1 month among each criterion among each group unpaired-t test~     and comparisons of two groups for each criterion by paired-t test.~   "
32165|NCT02636101|"~     This study aims to describe the patient population treated and the real-life patients'~     experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis~     vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling~     dermatologists and patients to optimize its use in the long term management of psoriasis.~   "
32166|NCT02636088|"~     In patients with esophageal cancer, treatment with curative intent can be given to medically~     fit patients without distant metastases. It may consist of chemoradiotherapy or surgery~     alone or in combination. Surgery in combination with chemotherapy is another option. For~     patients who are not medically fit for surgery or with unresectable invasion in adjacent~     structures the only alternative with curative intent is, with current knowledge, definitive~     chemoradiotherapy. In the current study the investigators aim to improve prognosis for~     patients not suitable for surgery. Patients receive treatment with conventional~     chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more~     recently developed drug, an antibody called cetuximab.~   "
32167|NCT02636075|"~     This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward~     in Parathyroid Hyperplasia Cases or not.~   "
32168|NCT02636062|"~     This study is a non-randomized prospective cohort study that will define the rate of index~     atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC)~     score of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood,~     and endothelial dysfunction will be performed to investigate any detectable systemic~     processes that predict CAC development.~   "
32169|NCT02636049|"~     This is a Phase 1, open-label, three-period sequential dosing study being conducted to~     determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy~     adults.~   "
32170|NCT02636036|"~     This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev~     administered in combination with nivolumab in subjects with metastatic or advanced~     epithelial tumors (with focus on CRC, UCC, SCCHN and salivary gland cancer) not responding~     to standard therapy.~   "
32171|NCT02636023|"~     The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device~     called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment~     of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the~     waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the~     electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The~     SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG~     waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low~     frequency vibrations are transmitted through the sternum. Using the point of initiation of~     ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous~     seismocardiograph, it is possible to determine timing events of the cardiac cycle. The~     timing events of the cardiac cycle during systole are referred to as Systolic Timing~     Intervals (STI) and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection~     Time (LVET). The PEP is the time from the Q wave to the Aortic valve opening. The Left~     Ventricular Eject Time (LVET) is the time between the Aortic Valve opening and closing. The~     ratio of PEP/LVET in individuals with established heart disease is > 0.42. It is based on~     the formula described by Dr Arnold Weissler and first published in Circulation in 1968~     (Weissler et al,1968). Weissler et al showed that the PEP/LVET ratio >0.42 are indicative of~     a lengthening of the PEP with some marginal shortening of the LVET. This is indicative of~     pathology associated with the coronary circulation (Ahmed et al, 1972;). This ratio can then~     be used as part of a non-invasive quantitative assessment of cardiac performance (Lewis et~     al 1977).~      Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that~     otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to~     identify the dicrotic notch or Aortic Valve closure.~   "
32172|NCT02636010|"~     This is a national, multicenter, open label single-arm, non-comparative study that will~     determine the efficacy, safety and the changes in selected pharmacodynamics markers of~     MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a~     response with a previous treatment but who still display some residual disease.~      For this purpose, 20 MM patients, who have received any treatment of limited duration either~     at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with~     persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will~     be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks~     for 1 year, with a potential expansion of 1 additional year of treatment in case of clinical~     benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be~     evaluated to understand the role of this monoclonal antibody in this setting.~   "
32173|NCT02635997|"~     Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by~     several international, randomized, double-blind, controlled trials. These studies have not~     included patients from central america, to the best of our knowledge. Therefore, this~     open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m~     treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and~     health-related quality of life.~   "
32174|NCT02635984|"~     The objective of this study is to compare the effectiveness of olanzapine added to standard~     triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone~     in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients~     receiving highly or moderately emetogenic chemotherapy regimens.~   "
32179|NCT02635919|"~     The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and~     preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for~     Medication Adherence of Rx Pill), a smartphone application (app) for improving medication~     adherence among substance users. The investigators will compare 2 groups of cigarette~     smokers undergoing a quit attempt with varenicline (Chantix): a) an experimental group using~     the mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a~     smart pillbox that will a record a date and time-stamped medication event whenever pill box~     is opened and closed, and thus allow for primary measurement of medication adherence) and b)~     a control group using the MEMS Cap and mobile web-based surveys on their smartphone.~   "
32180|NCT02635906|"~     This is a randomized clinical trial with a control group, based on the guidelines of the~     CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer~     removal in patients submitted a coronary arteriography or coronary angioplasty and the~     control group will follow the standard nursing care for four hours.~   "
32181|NCT02635893|"~     This is a randomized, experimental study that examines the physiology of central nervous~     system pathways contributing to the control of bilateral movements in individuals with~     spinal cord injuries and promotes the recovery of lower-limb motor function through the use~     of stimulation and locomotor training.~   "
32182|NCT02635880|"~     To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM~     laser that offers multiple wavelengths for removal of benign pigmented lesions.~   "
32183|NCT02635867|"~     At present, dentistry aims for conservative treatments with the goal of maintaining as much~     tooth structure as possible. Dental caries remains the most prevalent chronic disease~     worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The~     carious lesion is considered deep when it goes through the main tissues of the tooth, and it~     can affect the pulp tissue, where the nerve and nutrients of the tooth are located. There~     are many treatment options for deep carious lesions and they vary by the clinical scenario.~     Vital pulp therapy has become a fairly predictable alternative treatment to pulpectomy (root~     canal therapy). The goal of vital pulp capping therapies is to keep the pulp of the teeth~     vital to prevent further interventions such as root canal treatments and complex restorative~     work. There are two main clinical scenarios when treating these lesions, depending on the~     remaining dentin thickness between the carious lesion and the pulp: vital direct and~     indirect pulp capping. Direct and indirect vital pulp therapies are routinely performed~     using different clinical protocols. The clinical protocols are selected based on the~     remaining dentin (between the tooth preparation and pulp) and the restorative materials.~     There are few studies that evaluate pulp capping method in adult teeth (permanent~     dentition); many studies have investigated baby teeth (deciduous teeth). Routine therapies~     include the using of adhesive restorations with and without an intermediate layer of~     restorative material. Calcium hydroxide based cements have been used for pulp capping as an~     intermediate layer of restorative material. More recently a new intermediate layer of~     restorative material composed of resin-modified calcium silicate has been indicated for use~     on direct and indirect pulp capping. The aims of this study are to compare, over a period of~     12 months, the post-operative sensitivity and pulp vitality of three indirect pulp capping~     protocols and two direct pulp capping protocol in vital teeth. This study will provide the~     necessary evidence to allow clinicians to select the best restorative protocol when treating~     deep carious lesions where indirect and direct pulp capping protocol are needed.~   "
32184|NCT02635854|"~     Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic~     shock in mice and human models. Platelets are actors in immunity and their activation can be~     complicated by tissue damage with vascular occlusions which can lead to organ dysfunction.~     Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet~     aggregates in septic shock.~   "
32185|NCT02635841|"~     Patients with pantothenate kinase-associated neurodegeneration (PKAN) who have completed the~     ApoPharma-sponsored study TIRCON2012V1-EXT and who wish to continue to take deferiprone will~     be offered the opportunity to receive it on a compassionate basis. Patients will be followed~     locally by their own neurologist or other appropriate specialist.~   "
32186|NCT02635828|"~     Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses~     surgical patients during the first 24 hours after a surgical procedure. The incidence of~     postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about~     30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study~     design of this single arm, non-randomized, pilot study assessed the efficacy and safety~     profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to~     prevent PONV in patients undergoing craniotomies under general anesthesia.~   "
32187|NCT02635815|"~     Background & Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively~     infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating~     the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of~     variceal bleeding in an Egyptian cohort with NCPH.~      Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were~     included. All underwent complete clinical evaluation, laboratory investigations, Color~     Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper~     gastrointestinal endoscopy. Patients were classified into two groups according to variceal~     bleeding: (1) Group I: twenty six patients with history of bleeding or had an attack of~     bleeding during one year follow-up; and (2) Group II: thirty four patients without bleeding.~   "
32188|NCT02635802|"~     Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset~     and short lasting duration. Remifentanil usually is used to help reducing the pain of~     patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in~     ICU small short time operation.The purpose of this study is to determine (1) whether~     remifentanil is effective in small short time operations in ICU or not, (2) the save range~     of remifentanil in small short time operations in ICU, (3) and the adverse reaction that~     happens in these operations.~   "
32189|NCT02635789|"~     The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical~     formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions~     in patients with tuberous sclerosis complex (TSC)~   "
32190|NCT02635776|"~     The purpose of this study is to demonstrate the efficacy and safety of AR101 through~     reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.~   "
32191|NCT02635763|"~     As the population ages, the frequency of surgery is increasing proportionally, bringing with~     it the challenge of managing older patients with frequent comorbid diseases and an increased~     risk of complications. Poor postoperative quality of recovery may result in patient and~     family suffering, a prolonged hospital stay, and a greater demand on health care~     resources.The purpose of this study was to evaluate the ultrasound guided percutaneous~     femoral nerve+lateral cutaneous nerve versus lumbar plexus+sacral plexus nerve block~     composite laryngeal mask anesthesia in elderly hip fracture surgery, the application of~     assessing their impact on the postoperative recovery quality.~   "
32195|NCT02635711|"~     Objectives: To evaluate the effects of a novel adapted Taekwondo (TKD) training programme on~     skeletal development and motor proficiency in pre-pubertal children with developmental~     coordination disorder (DCD).~      Hypothesis: The TKD group participants will have improved skeletal development and motor~     proficiency outcomes after adapted TKD training compared with the controls.~      Design and subjects: In this prospective, randomised, single-blinded controlled trial,~     approximately 104 children with DCD (6-9 years old) will be randomly assigned to either the~     adapted TKD group (n~52) or the control group (n~52).~      Interventions: Subjects in the intervention group will receive adapted TKD training for 3~     months (one supervised session/week plus daily home training, 1 hour per session), while~     subjects in the control group will receive no TKD training during the study period.~      Study instruments and outcomes: Primary outcome measures: delay in skeletal development and~     motor proficiency will be measured by an ultrasonic bone age system and the Movement~     Assessment Battery for Children, respectively. Secondary outcome measures: eye-hand~     coordination and standing balance will be measured by a computerised finger pointing test~     and the Sensory Organisation Test, respectively (pre-, post- and follow-up measurements).~      Data analysis: Data will be analysed via repeated-measure analysis of (co)variance followed~     by post-hoc tests, if appropriate (alpha = 0.05).~   "
32196|NCT02635698|"~     Compare percent change in loss of body weight between the OPTIFAST program and a food-based~     energy-deficit program~   "
32197|NCT02635685|"~     A cluster randomised study in the primary care setting to evaluate a electronic clinical~     decision tool for stroke prophylaxis in patients with atrial fibrillation.~   "
32198|NCT02635672|"~     Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and~     recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive~     non-hodgkin's lymphoma (NHL).~   "
32199|NCT02635659|"~     Intraileal infusion of nutrients results in a reduction in food intake. A previous study by~     our group showed that both sucrose and casein infusion resulted in an increase in satiety~     and release of gastrointestinal peptides and a decrease in hunger and food intake.~     Encapsulating both nutrients, daily ingestion of this micro encapsulate and hereby releasing~     them in the distal small intestine could result in a chronic ileal brake activation. The~     obtained reduction in food intake and caloric intake could help overweight subjects to lose~     weight.~   "
32200|NCT02635646|"~     The purpose of the study is to evaluate the effect of a family and interdisciplinary~     approach on individual and family insulin resistance and insulin secretion in patients with~     prediabetes.~   "
32201|NCT02635633|"~     The purpose of this study is to investigate a novel stimulation protocol of repetitive~     transcranial magnetic stimulation (rTMS) for the treatment of unifocal neocortical epilepsy,~     namely continuous thetaburst stimulation (cTBS). As this is a pilot study, the primary~     endpoint is on safety and tolerability of the treatment. However, information on clinical~     efficacy and mechanism of action will also be collected.~   "
32202|NCT02635620|"~     The purpose of this study is to investigate whether changing from conventional smoking to~     electronic cigarettes causes changes in conventional lung function parameters, bronchial~     reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and~     smoking behaviour.~   "
32203|NCT02635607|"~     The purpose of study is to compare the effectiveness of the Day-5 fixed administration of~     GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation~     in Chinese women with predicted high ovarian response, and the hypotheses is that the number~     of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.~   "
32204|NCT02635594|"~     Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function~     and parameters of recovery after physical exertion.~   "
32205|NCT02635581|"~     The purpose of this clinical trial is to evaluate the osteointegrative potential of the~     Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD)~     around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months~     after surgery.~   "
32206|NCT02635568|"~     Legalization of marijuana in Colorado for both medicinal and recreational purposes has led~     to a perception of its safety, which has not been well studied in pregnant or lactating~     women. The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is~     lipophilic and therefore presumed to be secreted into breast milk. Additionally, the~     difference between modes of consumption (ie. smoked vs. edible) has not been well described~     in regards to THC concentration in breast milk. The purpose of this small pilot study is to~     describe the presence and duration of THC expression in breast milk among women who have~     evidence of THC exposure at the time of labor and delivery or within 72 hours of delivery.~     The researchers hypothesize that women with positive urine drug screen for THC within 72~     hours of delivery may excrete THC in breast milk for a predicted period of time, and~     therefore the aim of this project is to determine timing to safely return to breastfeeding~     to decrease infant exposure to THC.~      The specific aims are to determine in women who test positive for THC at delivery:~        1. Determine length of time THC and metabolites are detected in breast milk of mothers who~          have a positive urine drug screen at the time of presentation for labor and delivery or~          within 72 hours of delivery.~        2. Determine length of time THC and metabolites are detected in breast milk of mothers~          with postnatal exposure of either ingested or inhaled marijuana, to inform~          recommendations on when to safely return to breastfeeding.~        3. Describe modes of marijuana consumption in women presenting for delivery and correlate~          with THC concentrations and persistence in breast milk.~   "
32222|NCT02635360|"~     The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in~     combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced~     cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will~     be administered after or during chemoradiation.~   "
32223|NCT02635347|"~     This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic~     Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver~     Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of~     lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of~     reperfusion. Interventions will take place after anesthesia induction but before surgery, at~     the completion of the procedure, and on the mornings of post-operative days 1-4.~   "
32207|NCT02635555|"~     At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a~     short acting opioid fentanyl (to increase block density) and a long acting opioid morphine~     (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean~     section.However, larger doses of local anesthetic drug when used in caesarean section~     commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our~     study the investigators will standardize the doses of both opioids (fentanyl/morphine) and~     adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight~     .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to~     the patient whilst minimizing harmful side effects. Our primary concern is the low blood~     pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby.~     The investigators propose that the extent of surgical anesthetic block, which is dependent~     on height and weight in our adjusted dose group, will provide adequate anesthesia for~     surgery and minimise maternal low blood pressure.~   "
32208|NCT02635542|"~     The investigators will conduct a prospective, randomized trial to assess the impact of~     neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory~     complications in cardiac surgical patients. The study will compare continual neuromuscular~     blockade with cisatracurium to a single dose of succinylcholine during general anesthesia~     for cardiac surgery.~   "
32209|NCT02635529|"~     Amniotic membrane may be considered as a biologically active scaffold, which in combination~     with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony~     Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the~     present study was to evaluate if a biologic AM in combination with DFDBA applied in~     periodontal IBDs would enhance the regeneration of periodontium.~   "
32210|NCT02635516|"~     This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood~     flow, improvements in brain functioning, and reductions in symptomology associated with~     traumatic brain injury (TBI) can result from treatments consisting of near-infrared~     phototherapy (NIR).~   "
32211|NCT02635503|"~     The purpose of this study is to compare the safety and efficacy of laparoscopic resection~     with natural orifice specimen extraction versus conventional laparoscopic surgery for~     sigmoid colon or rectal cancer.~   "
32212|NCT02635490|"~     The present study aims to investigate the relative efficacy, safety and risk of a~     single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic~     procedures for ureteral stones.~   "
32213|NCT02635477|"~     A multicenter prospective randomized clinical trial testing the hypothesis that a~     patient-centered actigraphy intervention will result in increased physical activity for~     frail older adults increase during the critical first 30 days after a cardiovascular~     hospitalization.~   "
32214|NCT02635464|"~     The study is designed to assess the safety and efficacy of allogeneic human umbilical~     cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold~     transplanted into patients with chronic ischemic cardiomyopathy.~   "
32215|NCT02635451|"~     To study the association between maternal serum vitamin C concentration in women with~     preterm premature rupture of membranes (PPROM) and women without PPROM.~   "
32216|NCT02635438|"~     The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/~     lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole Troche/~     Lozenges USP, 10 mg (Roxane Laboratories Inc., USA) in patients with oropharyngeal~     candidiasis, where this condition has been diagnosed by clinical examination and confirmed~     by fungal culture~   "
32217|NCT02635425|"~     The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve~     7eggs only in prevention of severe ovarian hyperstimulation syndrome.~   "
32218|NCT02635412|"~     This is a randomized controlled trial to investigate the optimal timing of delivery in~     clinically stable women with a suspected morbidly adherent placenta.~   "
32219|NCT02635399|"~     Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most~     important modality in the treatment. In the past, pancreaticoduodenectomy was associated~     with high morbidity and mortality. However, with the advances in techniques, including~     perioperative patient management, development of antibiotics, diagnostic radiology, and~     interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible~     operation. Postoperative complication rates are reported to be in 10 to 20% in experienced~     hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for~     periampullary cancer is actively considered.~      However, postoperative complications, such as postoperative pancreatic fistula, (POPF)~     delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still~     serious complications. Among these complications, delayed gastric emptying is considered~     less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in~     turn, may lead to delay in recovery of postoperative nutritional state and in severe cases,~     requires insertion of levine tube and long-term fasting.~      There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite~     cause have not been discovered yet. With the introduction of pylorus-preserving~     pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased.~     However, results of most randomized comparative studies had concluded that PPPD and PD have~     no significance in occurence of DGE.~      One hypothesis for cause of DGE we present here has to do with anatomic positioning of~     anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after~     PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often~     associated with one of postoperative complications, POPF. POPF may create inflammation~     around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary~     change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled~     towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and~     gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach~     and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon~     using sutures, and prevent possibility of angulation of DJ. This additional procedure may~     reduce occurence of DGE.~   "
32220|NCT02635386|"~     This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to~     directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin~     (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss~     medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and~     endocrinological parameters in overweight/obese non-diabetic women with PCOS. In this study,~     we will examine the efficacy of these therapies on metabolic parameters, body weight and~     body composition, anthropometric measurements, and reproductive function in a well-defined~     group of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their~     relationship to insulin resistance and obesity. We hope to determine which treatment(s)~     addressing the multifaceted disturbances of individual subgroups emerge as the preferable~     therapy.~   "
32221|NCT02635373|"~     Observational, registry, prospective, non-interventional collection of CUA patient data.~     Patient treatment is carried out within clinical routine, at the discretion of the~     physicians and according to existing treatment guidelines. Participating physicians will not~     be subject to any instructions with regard to the diagnosis and therapy of their patients.~   "
32224|NCT02635334|"~     This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years~     old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the~     treatment of asthma in subjects who are 12 month old and older. This study is being done~     because there has been no placebo controlled study of montelukast focused on this group of~     patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more~     likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to~     younger asthmatics. The pathophysiology of asthma in the elderly is typically different than~     in younger patients. This is a double-blind, placebo-controlled, crossover study.~     Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at~     least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco~     products in their lifetime. After a run-in period of one week, the study subjects will take~     montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa.~     Primary objectives of this study are to evaluate the effect of montelukast on asthma~     symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs~     of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether~     montelukast affects peripheral blood eosinophils counts and serum IgE levels.~   "
32225|NCT02635321|"~     Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders~     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and~     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into~     more than 31 different types.~      A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine~     Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause~     Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been~     reported.~      In this study, the investigators examine five new cases with the LGMD phenotype. The primary~     aim is to examine the muscle involvement using MRI.~   "
32226|NCT02635308|"~     This study evaluates the feasibility of implementing a unilaterally biased high-intensity~     resistance training to facilitate restorative vs. compensatory recovery after usual care~     physical therapy among older adults who have recently incurred a hip fracture. Additionally,~     physical performance during a sit-to-stand task, muscle function (strength/power), physical~     function measures, muscle composition, and muscle quality (force/unit area), are assessed~     before and after targeted high-intensity resistance training.~   "
32227|NCT02635295|"~     The aim of this study is:~        1. to evaluate the effectiveness of the nursing student - nurse teacher mobile cooperation~          (MC) during the clinical practicum,~        2. to measure the usability of the mobile application.~      The detailed research questions and hypothesis of this study are as follows:~        1. What is the impact of MC on the nurse competence level of nursing students evaluated by~          work role, teaching-coaching and therapeutic interventions?~           H1: Nursing students' using MC will have a stronger change in the self-assessed level~          of nurse competence than those using standard cooperation (SC).~           H2: Nursing students' using MC will have higher level of nurse competence assessed by~          mentors after clinical practicum than those using SC.~        2. What is the impact of MC on the clinical self-efficacy level of nursing students?~           H3: Nursing students' using mobile cooperation will have a stronger change in the~          self-assessed level of self-efficacy in clinical performance than those using standard~          cooperation.~        3. What is the impact of mobile cooperation on the satisfaction level of nursing students~          evaluated by supervisory relationship, pedagogical atmosphere on the ward and the role~          of nurse teacher?~           H4: Nursing students' using mobile cooperation will have higher level of satisfaction~          with the supervisory relationship, pedagogical atmosphere on the ward and the role of~          nurse teacher after clinical practicum than those using standard cooperation.~        4. What is the perceived usability of the mobile application by the intervention group?~      The ultimate goal is to establish a modern, innovative solution for the nursing student -~     nurse teacher cooperation to support and facilitate the clinical learning of nursing~     students during the clinical practicum.~   "
32228|NCT02635282|"~     The general objective of this study is to determine whether intranasal ketamine should be~     incorporated into formulary as an option to treat pain during minor procedures in the~     pediatric emergency department.~   "
32229|NCT02635269|"~     This study aims to characterize the pathophysiological mechanisms of 21 different metabolic~     myopathies. The study will focus on exercise capacity and the metabolic derangement during~     exercise.~   "
32230|NCT02635256|"~     Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe~     and feasible.~      Investigators initiated this multicenter phase II prospective trial to analyse feasibility~     (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised~     prostate cancer, who are ineligible for the PREFERE trial under the hypothesis that the~     ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant~     lower than 17.5%.~   "
32231|NCT02635243|"~     Primary Objective:~      To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544~     versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced~     hypoglycemia.~      Secondary Objective:~      To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of~     SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.~   "
32232|NCT02635230|"~     The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a~     CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by~     percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients~     current North American and European guidelines recommend a triple therapy strategy,~     including vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this~     triple therapy strategy is a significant increase in the risk of major bleeding.~     Furthermore, the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors~     as well as the non-vitamin K oral anticoagulants (NOAC), created numerous new antithrombotic~     treatment strategies for these patients with overlapping conditions. To date, evidence on~     the risks and benefits of these new antithrombotic treatment strategies is lacking.~      The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve~     prosthesis ánd undergoing coronary revascularisation through a better understanding of their~     demographics, antithrombotic management and related in-hospital and long-term outcomes. The~     WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment~     patterns and patient outcomes.~      Objective: To assess the different management patterns and related in-hospital and long-term~     safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12~     inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing~     coronary revascularisation.~   "
32261|NCT02634827|"~     This phase II trial studies how well midostaurin and decitabine work in treating older~     patients with newly diagnosed acute myeloid leukemia and FLT3 mutations. Midostaurin and~     decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
32475|NCT02632240|"~     The aim of this study is to compare the efficacy of dental root coverage using the tunnel~     technique with connective tissue graft (CTG) and the same technique with collagen matrix for~     treatment of multiple gingival recessions Miller Class I and II.~      This study is a randomized-controlled clinical trial of 6 months duration.~   "
32233|NCT02635217|"~     Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies~     (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of~     patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with~     a video camera on the end). An EGD is performed to examine the upper digestive tract to look~     for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube,~     stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the~     large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.~      During these procedures, room air is routinely used to insufflate (expand/inflate the~     stomach and the colon) to allow for better viewing of the lining of the upper and lower~     gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air)~     has been shown to possibly have less post-procedure patient discomfort. Additionally, when~     both procedures are performed in the same day, it is currently unknown as to which sequence~     of procedures is better overall -whether to perform the EGD before colonoscopy or vice~     versa.~      The overall aim of our research is to compare patients' comfort, total amount of sedation~     used, and overall satisfaction with the procedures between four randomly allocated groups,~     to see which method of insufflation and which procedural sequence is better when both~     procedures need to be performed in the same day. We hypothesize that in patients requiring~     same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used~     as an insufflator is the best tolerated sequence associated with decreased sedation use and~     increased patient satisfaction/comfort.~   "
32234|NCT02635204|"~     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical~     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.~   "
32235|NCT02635191|"~     This study is designed to compare the eradication rates，safety and compliance of tailored~     therapy to those of standard triple therapy in children with H. pylori infection. The~     primary purpose is to compare the eradication rates of children with H. pylori infection~     treated with tailored therapy to those treated with standard triple therapy. The secondary~     purpose is to evaluate the safety, compliance and factors that might affect eradication~     rates.~   "
32236|NCT02635178|"~     Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or~     compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the~     population. Whereas several first-line treatments have been established (e.g.,~     pharmacological and psychological), a substantial proportion of patients (40-60%) fail to~     experience symptom remission, underscoring the need for research in this area. One approach~     to increasing treatment efficacy is to target underlying risk factors or dysfunctions that~     may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive~     concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., It scares me~     when I am unable to keep my mind on a task). There is recent evidence that AS cognitive~     concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains.~     However, questions remain as to whether reductions in AS cognitive concerns will lead to~     subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate~     the efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.~   "
32237|NCT02635165|"~     Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by~     decreasing the length of stay and the late complications: pain chronicles, quality of life,~     respiratory function~   "
32238|NCT02635152|"~     The purpose of this study is to determine whether a computerized intervention designed to~     reduce appearance and evaluation related interpretation biases will reduce symptoms~     associated with body dysmorphic disorder.~   "
32239|NCT02635139|"~     Aim of the study is to investigate the impact of meal skipping (breakfast or dinner~     skipping) on the regulation of glucose metabolism and macronutrient balance~     (protein/fat/carbohydrate intake vs. -oxidation). An isoenergetic diet with 3 conventional~     meals (breakfast, lunch, dinner) serves as a control.~   "
32240|NCT02635113|"~     The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory~     stimulation system on a lower limb to improve gait stability and prevent falls. The~     investigators want to detect, assess and communicate fall risk indicators obtained via the~     shoe sensors, and assess effectiveness of a gait synchronized vibration system to the~     plantar surface in reducing fall risk.The system consists of a gait measurement module, an~     abnormal gait detection module, and a vibratory stimulation module.~   "
32241|NCT02635100|"~     Obstructive sleep apnea (OSA) is a prevalent disorders characterized by intermittent~     obstructions of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP)~     has been shown to be the most efficacious treatment for OSA. It consists of a small device~     that provides positive airway pressure delivered by a mask attached to the patients~     nose/mouth.~   "
32242|NCT02635087|"~     The investigators discover the investigators' miRNA tool can be a useful tool to predict the~     patients with stage II colon who can benefit from chemotherapy.Then the investigators plan~     to make an observation study that may validation this tool.~   "
32243|NCT02635074|"~     This phase I trial studies the side effects and best dose of ibrutinib when given together~     with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has~     returned after a period of improvement or has not responded to previous treatment. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving ibrutinib together with idarubicin and cytarabine~     may kill more cancer cells.~   "
32244|NCT02635061|"~     Determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated~     dose (MTD) of ACY 241 in combination with nivolumab.~   "
32327|NCT02633943|"~     This is a multi-center, long-term safety and efficacy follow-up study for subjects with~     hemoglobinopathies (β-thalassemia or severe sickle cell disease) who have been treated with~     ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After~     completing the parent clinical study (approximately 2 years), eligible subjects will be~     followed for an additional 13 years for a total of 15 years post-drug product infusion. No~     investigational drug product will be administered in the study.~   "
32245|NCT02635048|"~     Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the~     management of >20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to~     24-30F, which is referred to as Standard-PCNL. Standard PNL has an ideal stones free rate~     (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to~     standard PNL, mini-perc or mini-PCNL, 20F or less, was first introduced to pediatric~     procedure in 1997, and subsequently implemented in adults with the expectation of similar~     SFR and low morbidity in the past twenty years. Although abundant efforts have been done,~     whether mini-perc outweigh standard-PNL for the treatment of >20mm calculis in terms of~     efficiency and safety remains controversial.~      To solve this problem, we performed this multi-center randomized controlled trial (RCT).~   "
32246|NCT02635035|"~     The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With~     Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is~     a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate~     30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive~     Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week~     placebo washout period.~   "
32247|NCT02635022|"~     Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan~     Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan~     Branch.~      Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the~     Fracture Best Practice Standards' were implemented at the National Taiwan University~     Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with~     1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from~     both inpatients and outpatients. At the same time, a osteoporosis medication management~     service is also establish as a complement of FLS to enroll patients on antiosteoporosis~     medications (AOMs) but not necessary with fracture.~      Participating physicians will select those eligible for services and refer to study~     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture~     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,~     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic~     visit, telephone reminder and follow up for patients, and communicate with providers on~     regular bases.~      During the whole study period, the investigators planed to enroll 200 patients (with or~     without fracture). Each patient would be assessed at baseline, and every 4 months last for~     two years.~   "
32248|NCT02635009|"~     This randomized phase II/III trial studies how well whole-brain radiation therapy works and~     compares it with or without hippocampal avoidance in treating patients with small cell lung~     cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only~     (limited stage) or has spread outside of the lung in which it began or to other parts of the~     body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and~     shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding~     the hippocampus during whole-brain radiation could decrease the chance of side effects on~     memory and thinking. It is not yet known whether giving whole-brain radiation therapy is~     more effective with or without hippocampal avoidance in treating patients with small cell~     lung cancer.~   "
32249|NCT02634983|"~     The purpose of this study is to assess global ventilated lung volume in moderate to severe~     COPD patients using MRI lung imaging after 8 days of treatment with QVA149 compared to~     placebo.~   "
32250|NCT02634970|"~     There are limited prospective data regarding the potential benefit and risks associated with~     switching between anti-VEGF therapies in patients with nAMD who have initially achieved a~     favorable response to the first anti-VEGF therapy used but subsequently have evidence of~     increasing disease activity despite continuation of therapy. This study will fill this~     knowledge gap by prospectively evaluating the effectiveness and safety of switching from~     aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial~     treatment with aflibercept.~   "
32251|NCT02634957|"~     Absolute voice rest is commonly prescribed after vocal fold surgery, also known as~     phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of~     vocal folds, which could result in increasing tissue stiffness and limitations in optimal~     vocal outcome. Unfortunately there is no standardized protocol as to how long patients~     should rest their voice after phonomicrosurgery. To date, there are no studies in the~     literature directly comparing the impact of short-term and long-term voice rest on vocal~     fold healing and voice outcome after phonomicrosurgery.~   "
32252|NCT02634944|"~     The purpose of the proposed project is to determine if the VOMS is an effective screening~     tool to identify and track recovery of vestibular and ocular motor impairment and symptoms~     following mTBI, that corpsman-level medical personnel can successfully implement in combat~     and non-combat environments. A second purpose of the project is to determine if impairment~     and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.~   "
32253|NCT02634931|"~     The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with~     NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with~     tuberous sclerosis complex in the open-label trial.~   "
32262|NCT02634814|"~     The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for~     the novel indication of treating neuromuscular activation in individuals with knee~     osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to~     improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced~     rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating~     underlying neuromuscular activation deficits. The investigators seek to use TENS to excite~     neural pathways that immediately increase neuromuscular activation as well as cause~     sustained improvements in neuromuscular activation and greater strength gains in knee OA~     patients compared to traditional TE. The investigators will evaluate the effect of TENS+TE~     on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical~     activity, self-efficacy of physical activity, self-reported quality of life, disability and~     pain. The central hypothesis is that an enhanced TENS+TE intervention will lead to better~     clinical outcomes, increased physical activity, and improved general health. The rationale~     for conducting a small clinical trial, which demonstrates the feasibility and establishes~     the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the~     development of a future larger clinical trial to establish the efficacy of an enhanced~     rehabilitation strategy for knee OA. This hypothesis will be tested through two specific~     aims: 1) to collect and report data on the feasibility of conducting a clinical trial to~     evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating~     patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a~     4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength,~     neuromuscular activation, gait biomechanics, physical function, physical activity,~     self-efficacy of physical activity, self reported quality of life, disability, and pain in~     knee OA patients. Posttests will be at 4 and 8-weeks following baseline.~   "
32263|NCT02634801|"~     The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric~     acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque~     psoriasis who are naive to systemic treatment.~   "
32254|NCT02634918|"~     Hemophilia is a bleeding disorder (deficiency of a blood clotting factor/ protein) resulting~     in bleeding in joints and muscles. As patients continue to bleed into their joints they~     develop progressive joint damage leading to joint contractures, disability and days missed~     from work and school resulting in chronic debilitating pain and compromised quality of life.~     Current therapy is the administration of the missing protein or factor concentrate on a~     scheduled basis to prevent bleeding into the joints referred to as prophylaxis. This factor~     concentrate is expensive ~ $ 3,000 - 6,000 per infusion/ week in a child weighing 20 kg~     translating into $ 77,000 /yr for life. This regimen has been shown to be effective to~     prevent joint bleeds but the timing is unclear and not based on adequate evidence. Currently~     joint damage is diagnosed using MRI which is expensive and requires sedation in children < 6~     yrs of age. Therefore there is a need for a user friendly tool such as a ultrasound to~     monitor for the development of joint disease and tailor treatment based on an individual~     child's needs. This would also enable differentiating a joint bleed from a soft tissue bleed~     which present similarly and duration of treatment tends to be longer for a joint bleed.~     Acharya et al have previously shown that ultrasound is comparable to MRI for the diagnosis~     of hemophilic joint disease in hemophilia patients over the age of 6 years. However, the~     diagnostic findings in children < 18 years with hemophilia on ultrasound is not well~     defined(1).~      The hemophilic synovium after repeated joint bleeds reveals the development of new vessels~     which are fragile and contribute to recurrent joint bleeds. Acharya et al have previously~     shown that angiogenesis, a process of new vessel formation is active in hemophilic synovium~     and angiogenic markers were significantly elevated in hemophilic patients with joint disease~     when compared to those without (2). Since ultrasound can detect these new vessel changes in~     the hemophilic synovium in hemophilia patients with joint disease and hemophilia patients~     with joint disease demonstrate elevated markers of new vessel formation these investigators~     would now like to determine whether radiological findings of hemophilic joint disease~     correlate with serological angiogenic markers. This may enable the development of biomarkers~     for hemophilic joint disease.~      Findings from this study will enable the development of ultrasound as a user friendly tool~     in the hemophilia clinic in order to understand whether every pain and swelling in a joint~     is actually a joint bleed or soft tissue bleed and to monitor for joint changes to institute~     or augment scheduled factor infusions ( prophylaxis). This will also result in significant~     improvement in quality of life with tailored prophylaxis .~   "
32255|NCT02634905|"~     -  Atopic dermatitis is a chronic relapsing disease, which is highly prevalent in children~          (15%). Therapeutic patient education (TPE) has been recognized as a key priority topic~          for future AD research. The strongest evidence in favour of TPE efficacy in AD comes~          from a large study assessing repeated multi-disciplinary group education sessions in a~          hospital setting. However, this type of intervention is both resource and time~          consuming and is not adapted to typical French practice. However, in some french~          dermatology centers, simple first level nurse-led TPE interventions are offered in~          addition to physicians consultations. Unfortunately, the content of these interventions~          seems to vary greatly depending on the caregiver and the center and the benefits of~          these practices have not yet been assessed. Therefore, nurse-led TPE is not considered~          as current care in France for AD patients.~        -  Thus, there is a need to rigorously assess the benefits of additional, well-structured,~          simple nurse-led individual TPE interventions for children with AD and their families~          compared to standard care alone. This study will be the first large, adequately~          powered, multicenter RCT trial assessing this type of intervention in children with AD.~   "
32256|NCT02634892|"~     Objective - To demonstrate the efficacy of the pressure redistributing cooling mattress~     overlay compared to usual care in mitigating the progression of early pressure ulcers in~     critically ill (ICU) patients via a prospective randomized human clinical trial.~      Specific Aim - The clinical trial will evaluate the efficacy and safety of the PRO-TECT ™~     mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1~     and 2) and preventing further progression to more severe pressure ulcers (Stage 3 and 4) as~     well as potential faster regression (i.e. healing of Stage 1 and 2 pressures).~   "
32257|NCT02634879|"~     The shift towards value-based reimbursement in U.S. healthcare is accelerating. Payment~     reform initiatives have taken many shapes—accountable care organizations, bundled payments,~     value-based purchasing, medical homes, global payment—but all share the common strategy of~     tying provider (physician, hospital, health system) reimbursement to performance on costs,~     outcomes, or both. Yet, pay-for-performance has demonstrated little effect on physician~     behavior and patient outcomes. Payers and provider groups are in need of novel approaches to~     structure provider incentives—both financial and non-financial—to better promote the~     delivery of quality, cost-effective care. In this project, the study team plans to study how~     behavioral economic principles can improve the effectiveness of physician incentives to~     deliver higher quality and lower cost care. They will test the application of specific~     behavioral economic principles including immediacy, social pressure, and loss aversion in~     incentive design and implementation. The study will contribute to an empirical foundation~     for re-design of existing physician incentive programs and implementation of new policies~     through secondary data analyses and a multi-arm experiment that evaluate the impact of~     promising behavioral economics principles on the effectiveness of provider financial and~     nonfinancial incentives.~   "
32258|NCT02634866|"~     Arterial hypertension (AH) is an important clinical social and economic problem, related to~     the increased cardiovascular risk. AH is associated with cardiovascular hemodynamic~     alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of~     increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms~     of heart failure (HF) may occur. Thus, the identification of noninvasive markers related~     with the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial.~      Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from~     the limited possibility to assess the hemodynamic response to exercise. Thus, there is a~     need for more detailed methods of cardiovascular monitoring while exercise testing.~      We hypothesize that some new noninvasive hemodynamic parameters, characterizing left~     ventricular (LV) function and arterial stiffness, may help to predict the risk of~     cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, we assume that~     cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic~     monitoring (impedance cardiography and applanation tonometry), would provide additional~     value in the assessment of the cardiovascular hemodynamic response to exercise.~      The study is intended to verify these hypothesis.~   "
32259|NCT02634853|"~     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic~     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry~     eye.~   "
32260|NCT02634840|"~     Several technical modifications based on the anatomical position of the neurovascular bundle~     and its bony mandibular canal have been developed, aiming to prevent injury to the~     intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD)~     should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because~     direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce~     our modified BSSO technique and evaluate the subsequent incidence of postoperative~     neurosensory disturbance of the IAN.~   "
32264|NCT02634788|"~     The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine~     Sublingual Spray compared with placebo in subjects with postoperative pain after~     bunionectomy.~   "
32265|NCT02634775|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide~     the clinician with new diagnostic and therapeutic tools for the management of children with~     CKD, based on the improved understanding of uraemic toxicity.~      In UToPaed (part 1), the investigators will associate concentrations of a wide variety of~     uraemic toxins with different comorbidities in CKD children, i.e. growth, protein-energy~     wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep quality, and~     psychosocial and neurocognitive functioning (i.e. cross-sectional and longitudinal). Those~     toxins of which concentrations are best correlated with comorbidities during the progress of~     CKD and those having representative kinetics (UToPaed - part 2: Kinetic analysis) will be~     selected as markers. During this third part of UToPaed, these markers will be, together with~     the comorbidities, further tracked after interventions, i.e. starting on dialysis,~     transplantation, changes in dialysis strategy.~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of~     all children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
32266|NCT02634762|"~     This prospective validation study evaluates the ability of a risk algorithm, which can~     simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart~     failure presenting to the emergency department. The risk algorithms for prediction of 7-day~     (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST)~     have been previously derived.~   "
32267|NCT02634749|"~     Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and~     saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However,~     current dietary recommendations to infants are based on traditions and experiences whereas~     research is basically lacking.~      Towards the end of the first year of life the infant will normally become increasingly~     suspicious towards fruits and vegetables. However, these foods are an important part of~     healthy eating. When and how these food items should be introduced into the diet of young~     children is unclear.~      New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger~     intake of fruits, vegetables, whole grain, fish and game. In adults such diet improves~     weight and biomarkers of insulin resistance and cardiovascular disease. Since dietary~     preferences are founded early in life it is logical to introduce such a diet already when~     the child is starting complementary foods.~      In a randomized controlled study from 6 mo of age, we want to explore if a Nordic~     complementary diet with lower protein intake, more vegetable fats and a systematic~     introduction of fruits and greens will improve body composition, metabolic biomarkers, the~     composition of faecal microbiota (associated with obesity), cognitive development and the~     consumption of foods that can lay the foundation for better long-term diet. If the study has~     the expected results, these will have a direct impact on the dietary habits of Swedish~     children during infancy and childhood and thus their long-term health.~   "
32268|NCT02634736|"~     This cluster RCT study will investigate the effectiveness of strength/balance Exergames~     (exercise and computer games that use body movements as controls) developed to improve~     balance, function, prevent falls and increase exercise adherence for older people in the~     home setting. The proposal incorporates postural stability Exergames that have been~     developed with users based on best evidence strength and balance exercise (OTAGO and~     Postural Stability) currently used by therapists, safe for older people and can be used in~     the home setting~   "
32269|NCT02634723|"~     The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity,~     and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate~     to severe hemophilia A.~   "
32270|NCT02634710|"~     This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and~     disease control (local control, overall and progression-free survival) using~     hypofractionated preoperative radiation therapy in patients with primary localized soft~     tissue sarcomas (STS).~   "
32271|NCT02634697|"~     The purpose of this study is to determine if an eight week multimodal Relaxation Response~     Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency~     and quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a~     reduction in AF symptom score, perceived stress, anxiety, hostility and depression.~   "
32272|NCT02634684|"~     This application seeks renewed support for MH59803, Dopaminergic substrates of startle~     gating across species, to extend a clear path of bench-to-bedside progress towards a~     critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective~     disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies~     (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more~     effective treatments for this devastating disorder. MH59803 has investigated the neural~     regulation of laboratory-based measures of deficient information processing in SZ/SZA~     patients, using rodents and healthy human subjects (HS) to explicate the biology of these~     deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In~     its first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of~     startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2~     years of support, MH59803 studies moved from bench-to-bedside, focusing on dopamine (DA)~     agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in~     cross-species studies. These studies detected biological markers that predict PPI-enhancing~     and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to~     specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training~     in SZ/SZA patients. If confirmed in the present application, these predictions could help~     transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus~     reflects a logical progression of studies at systems and molecular levels, translated first~     to HS, and now to potentially transformative therapeutic models in SZ/SZA patients.~   "
32352|NCT02633618|"~     A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical~     Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the~     treatment of neuropathic pain.~   "
32273|NCT02634671|"~     Background:~      The present study aims to identify the mechanisms underlying the deficit in facial emotion~     recognition reported both in schizophrenia and the 22q11.2 deletion syndrome, and thus,~     reveal a distinction between the two disorders. Indeed, despite the clinical overlap between~     the two syndromes, some of the symptoms appear to be specific to only one of them. In~     particular, the disturbance of visual functions is specifically observed in the 22q11.2DS.~     Hence, the difficulties in facial emotion recognition in schizophrenia and in the 22q11.DS~     are likely accounted by different cognitive impairments. Investigating which mechanisms are~     disturbed would allow a specialized support for patients.~      Our main hypothesis is that the deficit in facial emotion recognition is more related to~     visual impairments in the 22q11.2DS than in schizophrenia. This hypothesis will be tested in~     two groups of patients (22q11.2DS and schizophrenic patients) and a control group (healthy~     subjects) using an experimental paradigm based on electroencephalography (EEG).~      A second aim of this study is to determine whether the severity of the two disorders'~     symptoms is correlated with the cerebral response to facial expressions. To answer this~     question, a set of clinical and neuropsychological tests will be conducted for each patient.~   "
32274|NCT02634658|"~     This study plans to learn more about whether simpler diagnostic tests can be used to~     identify the development of acute neuromuscular loss of function in patients with critical~     illness and respiratory failure receiving mechanical ventilation. ICU patients admitted to~     the University of Colorado Hospital will be screened for eligibility and enrollment in the~     study to receive weekly measurements of nerve and muscle function through nerve conduction~     studies (NCS), muscle ultrasound tests, and concentric needle electromyography (EMG) tests.~   "
32275|NCT02634645|"~     A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's~     esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy~     (EET).~   "
32276|NCT02634632|"~     Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various~     places of care that alongside the end of life, and even tend to be generalized to all areas~     related to health care in general. In this context, a prospective study to assess how the~     patient will seize the AD and identify the different problems writing these AD will be~     conducted. From this study, it will establish recommendations for the implementation of AD~     in the Multidisciplinary Oncology Department and Therapeutic Innovations service and in~     oncology in general. They will be asked patients if they choose to write their AD, complete~     and sign the AD pre-written in the book or not to draft their AD. The choice of the~     patients, but also the reasons they associate thereto and, where appropriate, their AD~     written will be collected. The patient will also inform its demographic and socio the case~     report (clinical data) should be completed by the investigator. During the first part of~     research, the use of AD by patients and will be assessed and analyzed in connection with the~     characteristics of these patients (history of the disease, course of care,~     socio-demographic) and the reasons they set out to explain their choice. For those who write~     their AD, they will, in a second step, subject to thematic content analysis to identify the~     main aspects that the subject convened to consider its end of life.This research therefore~     lead to the definition of the contours of a user device AD in oncology in general. This~     study was qualified biomedical research because of the sensitive nature of the study~     population and bring the patient to personal preoccupations when filling the questionnaire~     on the choice of directing advance directives and their contents.~   "
32277|NCT02634619|"~     The investigators propose a randomized non-blinded comparison of dorsal vs. ventral approach~     for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common~     method of repairing the strictured urethra. Current evidence suggests the two approaches for~     placement of the graft are equally successful at correcting the stricture and the two~     approaches have similar risks of complications. The investigators propose to randomly assign~     appropriately selected patients to either a dorsally- or ventrally-placed graft. No~     additional procedures beyond normal care protocol will be required of the patients. Success~     will be assessed via objective and subjective methods; complications will be tallied in a~     standardized fashion. Outcomes will be measured at two years.~   "
32278|NCT02634606|"~     Elevated blood cholesterol, and particularly LDL cholesterol, is a risk factor for heart~     disease. Tocotrienols are naturally-occurring compounds in foods that may have beneficial~     effects on blood cholesterol. Tocotrienols are members of the vitamin E family, and are~     found in barley, oats, rye, coconut oil and rice bran oil, but the richest source of~     tocotrienols is palm oil. Certain of these tocotrienols have been shown to be effective in~     lowering LDL (or 'bad') cholesterol, with no adverse effects on the HDL (or 'good')~     cholesterol. The purpose of this study is to determine the effects of a palm-oil derived~     tocotrienol supplement on blood cholesterol, and particularly LDL cholesterol, in~     individuals who are taking statins, and have either elevated or normal cholesterol levels.~     Study subjects will consume a palm-oil derived supplement of tocotrienol for 3 months to~     determine its effects on LDL cholesterol.~   "
32279|NCT02634593|"~     Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and~     for obesity and comorbid metabolic disease in the offspring. Results of previous~     intervention studies designed to improve the metabolic health of obese mothers, and thereby~     reduce the risk to their offspring, have been modest at best. Furthermore, few studies have~     proved to be efficacious among low income African American women who have high risk for the~     transmission of obesity to future generations. The purpose of this study is to examine the~     feasibility of changing the types of foods and drinks that are consumed at night during late~     pregnancy in order to improve maternal glucose tolerance and reduce the risk for future~     obesity in the child.~   "
32280|NCT02634580|"~     The primary hypothesis is that evolocumab (AMG 145) SC will be well tolerated and will~     result in greater reduction of LDL-C than ezetimibe.~   "
32281|NCT02634567|"~     Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of~     attention problems will be randomized to standard medical care (treatment as usual) or~     attention training, which will be completed at their home using a commercially available~     attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will~     undergo cognitive testing before and after intervention and at 6 months follow up.~   "
32476|NCT02632227|"~     The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel~     ultrasound)for the prediction of fluid responsiveness in children undergoing congenital~     heart surgery.~   "
32282|NCT02634541|"~     Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the~     spine and the sacroiliac joints. Inflammatory pathways are likely the central link from~     axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron~     emission tomography (PET) is the most sensitive method to detect inflammatory foci in~     clinical practice. A few small studies have demonstrated that PET imaging together with~     computed tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study~     suggested that antirheumatic treatment diminishes the inflammation detected in PET/CT. No~     study so far has disclosed whether aortic inflammation is present in patients with~     spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic~     treatment. The current study is aimed to grade the articular and aortic inflammatory signals~     in the PET/CT imaging before and after antirheumatic treatment of clinically active axial~     spondyloarthritis.~      Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as~     detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40~     patients have axial spondyloarthritis resistant to sulfasalazine or other conventional~     antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but~     with stable coronary heart disease and approximately 20 healthy controls will be taken as~     historical controls. All the axial spondyloarthritis patients are PET/CT scanned after~     inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based~     regimen for 12 weeks, which is the time point for a second PET scan for this subgroup.~     Adalimumab will be commenced for those without remission at 12 weeks. After another 16~     weeks, those with adalimumab will be scanned with PET/CT for the third time. The subgroup~     with active disease in spite of prior conventional treatment (n=40) is also scanned with~     PET/CT right after the enrolment and after 16-week treatment with adalimumab. The first 15~     patients form a pilot group, which is used to check the validity of the power calculation.~      The project will give essential new information on PET-detectable inflammation in the~     patients with axial spondyloarthritis. The results will be published in international~     publication series. The publications will form the basis for a doctoral thesis. Funding for~     the project comes from Abbvie Ltd.~   "
32283|NCT02634528|"~     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new~     human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin,~     Huminsulin® Basal. All participants will receive both study treatments on two separate~     dosing days.~   "
32284|NCT02634515|"~     This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the~     new short-acting human soluble insulin, Julphar Insulin R, and the already approved~     reference insulin, Huminsulin® Normal. The trial participants received both study treatments~     on two separate dosing days.~   "
32285|NCT02634502|"~     This study aims to explore the efficacy and safety of radiofrequency ablation combined with~     S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum~     microRNA and patients' prognosis. This protocol will be overseen by the Fudan University~     Institutional Review Board which has Federal Wide Assurance through the U.S. Department of~     Health & Human Services (Approved: April 25, 2002).~   "
32286|NCT02634489|"~     A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after~     co-administration of single entity tablets and of the combination tablet EC905 under steady~     state conditions at three dose strengths.~   "
32287|NCT02634476|"~     It is well-established that many substance misusers experience impairment in cognition~     (thinking skills), particularly those needed to regulate and monitor behaviour and ensure~     that goals are achieved. According to the dual-process model, addiction arises from an~     imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that~     drive behaviours and impaired 'top-down' controlling processes that stop behaviours~     associated with negative consequences. As a result, the individual becomes more sensitive to~     cues in their environment (e.g., alcohol images) that trigger the addictive behaviour.~     Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains~     the brain to pay less attention to negative/harmful cues and more attention to positive or~     neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the~     'top-down' control processes of unhealthy behaviors which enables the addicted individual to~     make better decisions. Recently, CBM has been used with addicted population to alter the~     tendency to approach alcohol, with one German study showing that a 4-session training~     programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The~     current study examines whether a novel computer based training programme alters cognitive~     biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients,~     and examine whether this enables them to be better at decision-making more generally, and~     its impact on craving and post-discharge abstinence rates. The study will also explore~     whether individual differences in impulsivity and sensitivity to reward and punishment~     determine response to the training programme. This will be achieved using a parallel-groups~     randomized superiority trial design involving approximately 80 patients attending inpatient~     withdrawal programmes in Victoria. The findings are likely to have implications for the~     design and delivery of psychosocial interventions delivered during early recovery from~     alcohol-dependence to optimise treatment effectiveness.~   "
32288|NCT02634463|"~     The purpose of this study is to collect whole blood and plasma venous and capillary samples~     from participants taking aripiprazole, olanzapine, paliperidone, or risperidone for the~     development of antipsychotic immunoassays.~   "
32289|NCT02634450|"~     In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18~     months of age) is conducted using molecular diagnostics at central laboratories in Maputo,~     Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the~     country do not have close access to laboratories. Test samples are transported over large~     distances and this can introduce testing delays, especially for patients in rural and remote~     areas of the country. There are now new POC EID technologies becoming available that will~     enable diagnosis of HIV in infants within minutes or a couple of hours on site in the~     clinic, operated by non technical staff and without laboratory infrastructure. This protocol~     describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis~     (EID) testing technologies that are being considered for use in Mozambique, and to pilot~     those technologies in order to provide more effective diagnostics and clinical care to~     patients. During this implementation pilot, sites are randomized to use either conventional~     or POC EID testing only before the inclusion of the patients in the study. No consent will~     be asked to the parents or guardians. A written permission will be asked to the Direção~     Provincial de Saúde of both provinces to implement the POC device as routine in those~     intervention sites. All the information that will be analyzed will be collected from the~     routine care and it will be analyzed as a group.~   "
32290|NCT02634437|"~     This study is designed to observe the effect of renal function on the pharmacokinetic,~     safety, and tolerability profiles of Ulipristal acetate following administration of a single~     oral dose of a 10 mg Ulipristal acetate tablet.~   "
32291|NCT02634424|"~     The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven~     prophylaxis in current clinical practice~   "
32311|NCT02634164|"~     Diabetes is classified as an impairment of the body's ability to control blood glucose~     levels. Uncontrolled hyperglycemia can give rise to macrovascular (i.e., heart disease and~     stroke) and microvasculature damage such as retinopathy, nephropathy and neuropathy. These~     comorbidities may definitively reduce quality of life.~      Hypotheses to be tested:~        1. The ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to~          a glucose load will concurrently and independently improve glucose tolerance.~        2. The ingestion of L-Isoleucine and L-Leucine separately or together will have a minimal~          effect on incretin responses of Glucagon-like peptide-1 and Glucose-dependent~          insulinotropic peptide (GLP-1, GIP).~   "
32292|NCT02634411|"~     Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units~     (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of~     antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less~     multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic~     Society to recommend SD therapy for VAP, with the exception of documented VAP of~     non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP),~     due to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of~     SD therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a~     higher rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD~     therapy group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially~     based on microbiological rather than clinical data, and the higher rate of recurrence~     observed could rather reflect a higher rate of colonization more than a new infection.~      Interestingly, a trend for a lower rate of mortality was also observed in the SD group~     (n=15, 23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly~     underpowered to detect a difference of mortality between groups.~      The two strategies were considered as not different, for the risk of mortality in a recent~     meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI~     [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains~     questionable considering the large confidence interval of the risk and the power of these~     studies.~      Primary objective and assessment criterion: To assess the non-inferiority of a short~     duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa~     ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality~     and PA-VAP recurrence rate during hospitalization in the ICU.~      Study Design :~      Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units~     participating to the study~      Research period:~      Total study duration: 27 months Inclusion period: 24 months Duration of participation for a~     patient: 90 days~   "
32293|NCT02634398|"~     The purpose of this Post Market Observational Study is to monitor the effect of the Axium®~     SCS System in the management of chronic pain following surgical lumbar discectomy in~     subjects whom are routinely scheduled for treatment with the Axium® SCS System.~   "
32294|NCT02634385|"~     Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small~     peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of~     endoscopic skill. Renal vessel clamp for vascular control is a required step during standard~     LPN. However, this creates a time limiting step for the surgeon and induces renal injury via~     warm ischemia and reperfusion injury. This novel approach can substantially reduce renal~     injury during LPN via superselective embolization of level II renal arteries~     pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia~     LPN, significantly simplifying the procedure by remove time thresholds within which to~     perform tumor excision. The preliminary results are promising; however, there is a need for~     further corroboration of their results, in addition to a randomized controlled trial~     comparing this modified, zero ischemia technique with standard LPN.~   "
32295|NCT02634372|"~     The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective~     in relapse prevention over an observational period of 2 years in bipolar patients with a~     history of traumatic events.~   "
32296|NCT02634359|"~     The study objective is to collect data to assess the accuracy and reliability of Earlysense~     fertility cycle monitoring performance vs. acceptable known reference methods such as blood~     tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation~     and pregnancy. In addition the collected data will be used to further enhance and improve~     the existing algorithms.~   "
32297|NCT02634346|"~     This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation~     of schizophrenia.~   "
32298|NCT02634333|"~     Multiple studies have implicated vascular endothelial growth factor VEGF as a major~     causative factor in human eye diseases characterized by neovascularization including~     proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic~     macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced~     in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in~     Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to~     Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent~     dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network~     protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would~     result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes~     subsequently would result in favorable visual acuity outcomes.~      If this study demonstrates that intravitreous aflibercept treatment is effective and safe~     for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk~     for these complications, a new strategy to prevent vision threatening complications of~     diabetes will be available for patients. The application of intravitreous aflibercept~     earlier in the course of disease (i.e., at the time when an eye has baseline severe~     non-proliferative diabetic retinopathy) could help to reduce future potential treatment~     burden in patients, at the same time resulting in similar or better long-term visual~     outcomes, if PDR and DME are prevented.~      The primary objectives of this protocol are to 1) determine the efficacy and safety of~     intravitreous aflibercept injections versus sham injections (observation) for prevention of~     PDR or CI-DME in eyes at high risk for development of these complications and 2) compare~     long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of~     disease with those that are observed initially, and treated only if high-risk PDR or CI-DME~     with vision loss develops.~      Secondary objectives include:~        -  Comparing other visual acuity outcomes between treatment groups, such as proportion of~          eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at~          least 5 letters at the consecutive study visit just before and at the 2- or 4-year~          visit~        -  Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT~          central subfield thickness and volume from baseline~        -  Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of~          diabetic retinopathy severity level (scale for individual eyes) by central reading~          center from baseline~        -  Comparing associated treatment and follow-up exam costs between treatment groups~        -  Comparing safety outcomes between treatment groups~   "
32299|NCT02634320|"~     This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as~     ARISTADA, ALKS 9070).~   "
32300|NCT02634307|"~     This study will evaluate the long-term safety and tolerability of ALKS 8700 for the~     treatment of Relapsing Remitting Multiple Sclerosis (RRMS)~   "
32301|NCT02634294|"~     Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with~     hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation~     (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years,~     without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).~      Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon~     alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or~     higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.~   "
32312|NCT02634151|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple~     doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not~     adequately controlled on high-intensity or moderate-intensity stable statin therapy.~     Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C~     value ≥ 100 mg/dL. Subjects will be randomized 1:1 to gemcabene 600 mg QD or placebo.~   "
32313|NCT02634138|"~     This study will assess the benefit of a neuromuscular electrical stimulation device in~     patients suffering from symptoms and effects of critical limb ischaemia.~   "
32537|NCT02631161|"~     A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin~     based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious~     cervical lesions.~   "
32302|NCT02634281|"~     SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the~     available cessation programs are not effective for all smokers, new strategies are necessary~     for tobacco control.~      Primary objective: To investigate whether a 6-week varenicline preloading facilitates~     smoking reduction and cessation compared with the standard varenicline treatment schedule.~      Design: Parallel group, double-blind, randomised controlled clinical trial. Participants:~     Smokers of both sexes from the general population. Methods: Participants will be randomized~     into two groups of treatment. Subjects in Group A will receive varenicline for six weeks~     while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During~     this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent.~     At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of~     varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day~     (QD)) and at week 1, 6, 12, and 24 after QD.~      Measurements: These will include vital signs, smoking history, spirometry, expired CO,~     salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is~     continuous abstinence at 6 months.~      Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A~     vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).~      Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test~     (nominal variables) will be used as appropriate.~      Expected benefits: This study might contribute to optimize the current use of varenicline.~   "
32303|NCT02634268|"~     Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI)~     overlap. The investigators are trying to find out if a program proven to help people lose a~     modest amount of weight and increase their physical activity will improve COPD symptoms for~     those with a high BMI. The program uses a series of digital video discs (DVD) sessions~     focused on healthy eating and physical activity, and encourages participants to monitor~     their weight, diet, and physical activity for two years. For those who want to, they will be~     able to work with a health coach to help meet weight and activity goals. We hope that the~     program will lead to weight loss, better exercise tolerance, and less shortness of breath.~     To be in the study, participants will need to have COPD, high BMI, history of smoking,~     shortness of breath, and be at least 40 years old.~   "
32304|NCT02634255|"~     Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to~     provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds~     after intravenous injection, patients can be intubated.~      Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients~     undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of~     this study is to investigate the effect of patient anxiety levels on the onset time of~     rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.~   "
32305|NCT02634242|"~     The purpose of the current study was to check the physiological improvement of SWT on liver~     and skin and also the antioxidation in healthy adults.~   "
32306|NCT02634229|"~     Monogenic diabetes accounts for 1-2% of diabetes cases, although it is often misdiagnosed as~     either type 1 diabetes or type 2 diabetes. Knowledge of the genetic etiology of diabetes~     enables more appropriate treatment, better prediction of disease progression, screening of~     family members and genetic counseling. These monogenic diabetes result from gene mutations~     that reduce beta-cell function. To date, about 20 genes involved in insulin-secretion~     pathway hav been identified; they correspond to a broad of two main clinical conditions~     [neonatal diabetes mellitus (NDM) and Maturity-Onset Diabetes of the Young (MODY)]. However,~     it still remains subtypes of monogenic diabetes that are unelucidated. The investigators~     project focus on families with a clinical and familial history highly suggesting a MODY~     diabetes but without genetic etiology. The investigators objective is to set up a collection~     of families with at least three family members presenting a MODY diabetes.~   "
32307|NCT02634216|"~     The purpose of this 12 week longitudinal study is to test the effect of the dietary~     supplement, Capros, on blood glycemic index of Type 1 diabetics that have a sensor that~     provides continuous glucose monitoring (CGM). 20 Type 1 Diabetics will take the Capros~     supplement for 12 weeks to determine the effect of blood glycemic index. Capros, is a~     generally safe dietary supplement currently sold over the counter in the United States. Type~     1 diabetes also known as juvenile diabetes is commonly diagnosed in children and young~     adults. Insulin is converted into energy needed for daily living, and with diabetes, insulin~     is not produced in the body as it should causing many problems. In traditional Indian~     medicine, the gooseberry Phyllanthus emblica has been used for thousands of years as an~     effective source of polyphenols and antioxidants. A 12 week longitudinal study to determine~     the effect of the dietary supplement, Capros, on the blood glycemic index in patients with~     Type 1 diabetes (T1D).~   "
32308|NCT02634203|"~     Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary~     hypertension characterized by obstruction of the pulmonary vasculature by residual organized~     thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary~     hypertension, and right failure.~      In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment~     and is the only potentially curative treatment. However, some patients are ineligible for~     surgery owing to occlusion of distal vessels. The best treatment option for these~     non-operable CTEPH patients is not yet established.~   "
32309|NCT02634190|"~     To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the~     APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of~     HPV infection and high-grade CIN lesions in a screening population of women 30 years of age~     or older in Germany.~   "
32310|NCT02634177|"~     In this randomized clinical trial, subjects will be assigned to either an assay-guided~     treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide~     a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay~     results will be provided to the treating investigator, who will use the results to guide~     antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the~     subjects without the knowledge of the pharmacogenetic testing results. Assay results for all~     subjects will be provided to the investigator once all Week 8 visit procedures have been~     completed. Raters of the primary endpoint assessment and subjects will remain blinded to~     treatment assignment.~   "
32314|NCT02634112|"~     Primary Endpoint:~      The main objective of this National Registry is to identify the incidence and to analyse the~     risk factors for anastomotic leakage in rectal cancer surgery From the operational point of~     view, the aim of this Registry is to systematize the collection of information on the~     different surgical services. This Registry claims to have National audit functions, allowing~     thus the knowledge of the procedures performed at each center that could enable the~     establishment of the best standard of care.~      Secondary Endpoints:~      To determine the real incidence of anastomotic leakage according to the different locations~     and techniques: uniform definition of anastomotic leakage.~      To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.~      To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.~      To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL~     FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and~     mortality.~      To create and validate an anastomotic leakage predictive Score.~   "
32315|NCT02634099|"~     Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels~   "
32316|NCT02634086|"~     The study is to determine the long-term outcome of patients with coronary triple vessels~     disease (TVD) in the real world of China, by three different treatment strategies:~     percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal~     medication therapy (OMT).~   "
32317|NCT02634073|"~     Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral~     agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults~     and children. Documented literature elucidates that simultaneous administration of multiple~     sorbitol-containing products could increase the potential for a significant interaction and~     may contribute to the lower 3TC exposures.~      In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be~     administered with lamivudine to investigate dose dependency and mimic the situation where~     multiple sorbitol-containing antiretroviral medications may be co-administered with~     lamivudine. It will be open label, randomized, 4-way crossover (by William's design method)~     design at a single centre. Randomized participants will receive a single dose of each of~     four treatments after wash out period of minimum 7 days.~   "
32318|NCT02634060|"~     Recently a smartphone application IBDoc® was developed to enable patients to measure faecal~     calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of~     these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term~     outcome to ADA induction therapy in patients with moderate-to-severe IBD.~      Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will~     be asked to participate in this study. They will be asked to collect a stool sample at 3~     different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test~     cassette with an extraction device. In a second step, the patient can turn his smartphone~     into an easy to use test cassette reader by taking a picture and using the CalApp® which is~     based on an immunochromatographic test. Finally, the CalApp® will transmit the test results~     securely to the health care professional.~      In this study we want to evaluate the predictive value of absolute and relative faecal~     calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at~     week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA~     measurements of faecal calprotectin, and the convenience of this system to the patient and~     the health care professional.~   "
32319|NCT02634047|"~     The primary aim of this study is to investigate the difference in the first attempt and~     overall success rate of different techniques for insertion of transesophageal~     echocardiography. Secondary aim is to investigate the difference of the duration of~     insertion using the selected technique, complications during insertion such as oropharyngeal~     mucosal injury and hematoma.~   "
32320|NCT02634034|"~     The purpose of this study is to compare the pharmacokinetics and safety of a controlled~     release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR)~     pitavastatin in healthy adult volunteers.~   "
32321|NCT02634021|"~     Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and~     hypertension.~   "
32322|NCT02634008|"~     An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir,~     dasabuvir with or without ribavirin for people with recently acquired hepatitis C virus~     infection with or without HIV co-infection.~   "
32323|NCT02633995|"~     The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as~     these patients present particular hazards with general anaesthesia, such as concerns for~     rapid airway control and cerebral blood flow alterations during induction of general~     anaesthesia and intubation However, the incidence of hypotension is high during spinal~     anesthesia for Cesarean section and it may approach values up to 95 %.~   "
32324|NCT02633982|"~     In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke~     preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering~     this,warfarin is a drug which puts a great burden on patients and medical providers.~      With the population aging, the number of non-valvular atrial fibrillation patients is~     increasing, and a necessity that not only specialist but also general practitioners.~     Anticoagulant therapy with warfarin is not easy for general practitioners and is not~     commonly used among general practioners. In such circumstances, Rivaroxaban,a new oral~     direct factor Xa inhibitor,has become available. Rivaroxaban is administrated once a day and~     exert an anti- coagulant effect soon after administration. It hardly reacts with foods or~     other drugs and therefore does not require regular monitoring. GENERAL study is to~     investigate the effectiveness of stroke and systemic embolism in non-valvular atrial~     fibrillation patients when it is prescribed by general practioners in real life settings.~   "
32325|NCT02633969|"~     The purposes of this study are to evaluate the safety and tolerability and to model the~     single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in~     children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.~   "
32326|NCT02633956|"~     This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an~     open-label LTSE, will evaluate the effect of Obeticholic Acid, and the subsequent addition~     of statin therapy, on lipoprotein metabolism in subjects with NASH with fibrosis stage 1 to~     4, but no evidence of hepatic decompensation.~   "
32328|NCT02633930|"~     This study aims at evaluating efficacy and safety of berberine-containing quadruple~     therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing~     quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori~     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior~     to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive~     status will be randomized to one of the treatments described above. At week 2 and 6~     follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.~   "
32329|NCT02633917|"~     The purpose of the present study was to evaluate and compare the effects of motor control~     exercises and standard exercises in the pain, incapacity and medicine intake of subjects~     with unspecific low-back pain.~   "
32330|NCT02633904|"~     Although older children and high dislocations may be more likely to require a femoral~     shortening osteotomy, the ultimate decision about whether or not to shorten a given femur~     should depend on the ease of femoral head reduction in that specific patient. Adding a~     femoral shortening procedure increases operating time and blood loss, adds a second~     incision, and necessitates future hardware removal. In addition, an unnecessary femoral~     shortening osteotomy could overly decrease the soft tissue tension around the joint, putting~     the hip at risk for redislocation. This study was designed to explore an algorithm based on~     strict age and radiographic criteria that identify those without the need of femoral~     osteotomy.~   "
32331|NCT02633891|"~     Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the~     MetS are at risk for not only future chronic diseases, but they have a higher prevalence of~     neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls.~     Currently there are no effective therapies to prevent or reverse the neuropathy seen in the~     MetS or to reduced the fall risk in this population. This research project will determine if~     a tailored balance exercise program will have functional benefits and result in a reduced~     fall risk in the growing population of patients with the MetS and neuropathy.~   "
32332|NCT02633878|"~     Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain,~     while the cervix is closed and the fetus is viable and inside the uterine cavity.Threatened~     miscarriage is a common complication of pregnancy occurring in 20% of all clinically~     recognized pregnancies and about half of these will eventually result in pregnancy~     loss.Micronized progesterone which is used in a range of indications including infertility~     due to luteal insufﬁciency and threatened and habitual abortion, has a similar molecular~     structure and pharmacological effects to endogenous progesterone.Chinese Herbal Medicines is~     a part of Traditional Chinese Medicines and has been widely used for the treatment of~     miscarriage in China and other Asian countries for centuries.CHM have become very popular~     alternative to Western medicines and are commonly used as an alternative treatment for~     threatened miscarriage.Amongst all the causes for threatened miscarriage, Kidney~     Deficiency is the most important cause leading to threatened miscarriage and Shou Tai~     Pill is the most frequently used formula (72.0%) to treat threatened miscarriage.This basic~     formula is made up of four individual Chinese medicines, including Chinese Dodder Seed~     (Semen Cuscuta), Chinese Taxillus Twig (Flerlia Taxillus), Himalayan Teasel Root (Radix~     Dipsaci), and Donkey-hide Glue (Colla Corii Asini).Furthermore, supplementary of~     Common/Wingde Yan Rhizoma in the formula can enhance the therapeutic effects by further~     strengthening kidney of pregnant women.The goal of this double-bind, randomized and double~     dummy controlled trial is to determine which of the two oral medications, CHM or Micronized~     progesterone, and will mostly likely result in live birth in women with threatened~     miscarriage.~   "
32333|NCT02633865|"~     Age-related cataracts remain the leading cause of treatable blindness in China. The~     prevalence of cataract blindness continues to climb due to the expanding elderly~     subpopulation. Surgery is the only available treatment; however, the cataract surgical rate~     (CSR) in China remains relatively low relative to affluent countries or certain developing~     areas. Studies have reported that the primary barrier to cataract surgery is financial~     difficulty, and this challenge could be efficiently addressed by reducing the surgical fee~     or providing free cataract surgery. However, the prices, availability and affordability of~     medicines or medical services to the poor in China require further improvement. Although a~     host of free cataract screening and surgery programs have been widely implemented in rural~     areas of China, free cataract surgery programs have rarely been implemented in~     financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in~     China, many low-income cataract patients, a neglected cohort, continue to need cataract~     surgery. A program titled care for your eyes, lighten your life, jointly sponsored by the~     People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou~     Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to~     implement a program of free clinics in parks and free cataract surgery targeting the~     impoverished population living in urban China in 2012. After 3 years' exploration, the~     management mode of this program has been perfected, and approximately 4000 cataract~     surgeries had been performed on the low-income elderly.~      Although there are a large number of poor communities throughout the country, free cataract~     surgery programs in poor urban China are restricted to several metropolises due to limited~     medical resources and social overlook. Fully understanding patient satisfaction regarding~     the free cataract surgery program and understanding the patient characteristics of this~     special, neglected community may contribute to the improvement and the further expansion of~     the management mode of free cataract surgery programs.~   "
32334|NCT02633852|"~     A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of~     Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema -~     TADI Study~   "
32335|NCT02633839|"~     This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety~     of a single dose of CVT-301 in smoking and non-smoking adults.~   "
32336|NCT02633826|"~     This investigator-initiated study will analyse the role of pre-formed alloreactive T cells~     on acute rejection episodes and graft outcome in kidney transplant recipients after living~     donation.~   "
32337|NCT02633813|"~     The current study was randomized, double blind, placebo-controlled, prospective,~     multicenter, comparative therapeutic equivalence study.~      The study duration for each patient was 6 weeks: Following were the visit details.~      V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2~     + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at~     the end of week 6 + 4 days).~   "
32338|NCT02633800|"~     This is a 'randomized study' which means you may receive a substance that looks like the~     active medication but is not (called placebo). The study will test an investigational study~     drug called patritumab/placebo. Patritumab may work when combined with other medications~     that are approved for the treatment of head and neck cancer. They are called cetuximab,~     cisplatin or carboplatin.~   "
32552|NCT02630966|"~     The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different~     dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with~     fistulizing Crohn's disease (CD).~   "
32339|NCT02633787|"~     The aim of this study is to provide information on the persistence of bactericidal~     antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).~      Objective:~        -  To evaluate the persistence of antibody responses (determined by a serum bactericidal~          assay using human complement (SBA-HC)) approximately 4 years after the administration~          of a booster dose of Menactra vaccine in trial MTA77~   "
32340|NCT02633774|"~     Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or~     dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion.~     The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with~     hemodynamic amelioration compared to AF state. We will randomize the patients with~     persistent AF to rhythm control group and rate control group, and check baseline and 3rd~     month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain~     perfusion CT findings will be compared between rhythm control group and rate control group~     of persistent AF.~   "
32341|NCT02633761|"~     The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus~     misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.~   "
32342|NCT02633748|"~     Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but~     has not been extensively studied in cancer survivors. This study will enroll cancer~     survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology~     and Survivorship to undergo the Mindfulness Based Cancer Survivorship (MBCS) four-week~     program, with assessments before, immediately after, and three months after the~     intervention. Results of the study will be used to develop new care models that improve~     cancer survivor stress and symptoms using mindfulness.~   "
32343|NCT02633735|"~     Although appendicitis is the most common surgical emergency in children, its diagnosis~     remains a challenge and thus, emergency department (ED) providers increasingly rely on~     computed tomography to distinguish appendicitis from other conditions. This project (a) uses~     electronic health record (EHR) technology to deliver patient-specific clinical decision~     support to ED providers at the point of care, (b) assesses the impact of this intervention~     on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the~     intervention on the costs of care delivered. This innovative project will be a template for~     extending EHR-based clinical decision support to other domains of emergency care to~     ultimately improve a broad range of pediatric acute care outcomes.~      The proposed intervention, referred to as appy-CDS, is specifically designed for widespread~     use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and~     adolescent patients with acute abdominal pain while maintaining or improving clinical~     outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical~     decision support tool to optimize care for children and adolescents presenting to a general~     or non-pediatric ED with acute abdominal pain.~   "
32344|NCT02633722|"~     Obesity is a serious medical condition, the adverse consequences of which include increased~     risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The~     economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in~     mice and non-human primates have shown that moderate caloric restriction (CR) increases~     lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes.~     Reduced risk of chronic diseases is also observed in humans following CR. However, daily CR~     is difficult to maintain long term, since the body defends against weight loss by inducing~     metabolic adaptation and altering the hormonal appetite response. An emerging number of~     studies are examining the effects of limiting food intake to prescribed time periods per~     day, or every other day. Intermittent, or time restricted feeding describes a dieting~     approach where food is available ad libitum, however only for a limited period of time (i.e.~     3-12 hours). This study will examine the effects of fasting for 15h/day and eating for 9-h~     per day on glycemic control and metabolic health. This study will build on the existing~     knowledge base in humans as to whether meal timing, rather than caloric restriction per se,~     is important to provide the stimulus required to improve metabolic health and reduce risk of~     chronic disease. Moreover, it will examine whether restricting feeding to later in the day~     is of lesser benefit to health.~   "
32345|NCT02633709|"~     The objective of this study is to assess the safety and tolerability of RO7034067 (RG7916)~     in healthy people. The study will assess what the body does to RO7034067 (RG7916) and what~     RO7034067 (RG7916) does to the body. RO7034067 (RG7916) will be given by mouth in gradually~     increasing doses. The data from this study will help to define the dose to further explore~     RO7034067 (RG7916) in patients with Spinal Muscular Atrophy.~   "
32346|NCT02633696|"~     This clinical trial phase I in healthy volunteers is intended to describe the oral~     bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the~     curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and~     intravenous silybin (AUC iv).~   "
32347|NCT02633683|"~     The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT~     (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years~     of age) diagnosed with moderate-to-severe primary RLS.~   "
32348|NCT02633670|"~     Kidney transplantation remains one of the most common organ transplanted today but the~     surgical technique has changed very little from the original pelvic operation. The deceased~     donor renal transplant poses a particular challenge to the surgeon due to lack of detailed~     pre operative vascular assessment. The hemopatch is a promising new sealing synthetic~     hemostatIc agent with a novel dual mechanism of action that is more convenient to apply~     rather then using other hemostatic agents, which require warming and/or mixing.~   "
32349|NCT02633657|"~     The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the~     single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years~     of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).~   "
32350|NCT02633644|"~     The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony~     System for the treatment of heart failure~   "
32351|NCT02633631|"~     The Contraceptive Choice Center will use an innovative-model of contraceptive care which was~     developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will~     deliver high-quality family planning services for women and reduce unintended pregnancies~     and births. This intervention will result in improved health for women, improved health~     care, and reduced costs to Medicaid.~      The Center will provide care to women ages 14-45 years of age.~   "
32353|NCT02633605|"~     First Sense Medical®, LLC is a medical device company developing a novel breast cancer~     screening tester called the First Sense Breast Exam® Tester. This radiation free tester is~     being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory.~     When the tester is in production, a test will take approximately 7 minutes and will be~     performed in a doctor's office.~   "
32354|NCT02633592|"~     To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more~     naturalistic / physiological upright, seated position on a commode provides a more valid~     assessment of anorectal function and simulated defecation than the same test performed in~     the standard, left lateral position~   "
32355|NCT02633579|"~     In this study, the investigators will evaluate if the food intake associated with the~     infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown~     effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic~     receptor antagonist, to inhibit the formation of contractions induced by a low dose of~     erythromycin~   "
32356|NCT02633566|"~     The purpose of this study is to investigate the efficay of functional plantar orthoses on~     flatfoot in children.~   "
32357|NCT02633553|"~     This study is designed to investigate whether adjuvant radiotherapy after complete resection~     has a better survival for stage II or III thymoma.~   "
32358|NCT02633540|"~     The aim of this study is to define a new treatment technique for T1a larynx cancer that~     maintains excellent local control with less extensive radiation fields. It is thought that~     this will lead to patients having fewer changes to their voice and a higher quality of life~     after treatment when compared to the current standard treatment.~   "
32359|NCT02633527|"~     This is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,~     fixed dose study to assess the efficacy and safety of SPN-812 ER in treatment of children~     aged 6-12 years with ADHD. The primary objective is to assess the effect of SPN-812 ER in~     reducing ADHD symptoms. This will be measured using the ADHD-RS-IV rating scale.~   "
32360|NCT02633514|"~     This study is designed to investigate whether adjuvant radiochemotherapy after incomplete~     resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.~   "
32361|NCT02633501|"~     The purpose of this study is to determine an effective and safe clinical dose of a new~     gadolinium-based contrast agent (GBCA) P03277 injection for Central Nervous System (CNS)~     lesion detection and visualization by conventional steady-state CNS imaging. Therefore,~     Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to~     contrast medium/GBCA efficacy, has been chosen as the primary endpoint in order to have a~     precise determination of P03277 clinical dose.~      This is a multi-center, international, prospective, double-blind, randomized, controlled,~     parallel dose groups, cross-over with comparator study in male and female subjects~     presenting with either known or highly suspected focal areas of disruption of the Blood~     Brain Barrier (BBB) (e.g. primary and secondary tumors, focal inflammatory or demyelination~     disorders), who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance~     Imaging (MRI) of the CNS.~      This study will be conducted in approximately 40 centers worldwide.~      Two subsets of subjects will be included in the study:~        -  The first subset will include the first subject of each study center. Subjects will be~          administered at 0.05 or 0.1 mmol/kg body weight (BW) of P03277 and MultiHance®, 0.1~          mmol/kg BW.~        -  The second subset will comprise all other subjects selected by the sites. Subjects will~          be administered at 0.025, 0.05, 0.1, 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of~          MultiHance®.~      During the course of the study, two MRIs will be obtained from each subject: one unenhanced~     and P03277-enhanced MRI; and one unenhanced and MultiHance®-enhanced MRI. MRI evaluations~     will be performed by on-site investigators and three independent off-site blinded readers.~   "
32362|NCT02633488|"~     The purpose of this study is to look at how insulin (a hormone that helps the cells get~     energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels~     and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes~     you more sensitive to insulin) affects insulin's action on the blood vessels.~   "
32363|NCT02633475|"~     This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G~     polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women~     with IRM and 100 control women with a successful pregnancy will be included in this study.~     Then genotyping will be performed.~   "
32364|NCT02633462|"~     The Purpose of this study is to assess the correlation between the inflammatory periodontal~     status and the medical treatment status in Polycystic Ovary Syndrome(PCOS) women with~     systemic inflammation and to evaluate the effect of non-surgical periodontal therapy in the~     form of scaling and root planing along with medical treatment on the level of serological~     marker of inflammation (High sensitivity-C Reactive Protein) and insulin resistance in PCOS~     women with chronic periodontitis.~   "
32365|NCT02633449|"~     The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with~     prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to~     symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.~   "
32366|NCT02633436|"~     To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence~     of esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer~     tissues and adjacent tissues.~   "
32376|NCT02633293|"~     This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled~     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with~     interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE).~     The study will include about 266 patients who completed all required assessments in the~     RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your~     participation in this study is voluntary and will last until you discontinue from the study~     or the study ends. The study will continue until each subject reaches the Week 108 visit or~     until inhaled treprostinil become commercially available for patients with PH associated~     with ILD including CPFE (whichever is sooner).~   "
32434|NCT02632786|"~     This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,~     two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered~     intravenously in adults with AL amyloidosis who had a hematologic response to previous~     treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])~     and have persistent cardiac dysfunction.~   "
32367|NCT02633423|"~     During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed.~     The reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the~     FRC and leads to a phenomenon called expiratory flow limitation (EFL). Positive~     End-Expiratory Pressure (PEEP) test is a validated method to evaluate the presence of EFL~     during anesthesia. Aim of the study will be to asses if mechanical ventilation during~     CardioPulmonary Bypass (CPB) in cardiac surgery could reduce the incidence of EFL in the~     post-CPB period. Primary end-point will be the incidence of EFL, assessed by a PEEP test,~     performed at different time-points in operating room. Co-primary end-point will be shunt~     fraction, determined before and after surgery.~      This will be a single center single-blind parallel group randomized controlled trial.~     Patients will be randomly assigned to three parallel arms with an allocation ratio 1:1:1, to~     receive one of three mechanical ventilation strategies during CPB.~        1. Ventilation stop during CPB;~        2. Continuous Positive Airway Pressure (CPAP) during CPB, with an airway pressure of 5~          cmH2O;~        3. Low tidal low frequency ventilation, with 5 acts per minute, with a tidal volume of 2-3~          ml/kg of IBW and a PEEP of 5 cmH2O.~   "
32368|NCT02633410|"~     The anteromedial (AM) portal technique was introduced to position the femoral tunnel in~     anterior cruciate ligament (ACL) reconstruction to more closely replicate the original~     footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated~     differences in these techniques with respect to clinical outcomes. The purpose of this study~     was to determine if there are any differences in clinical outcome between the AM and TT~     approaches.~   "
32369|NCT02633397|"~     The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled,~     parallel groups study aimed to evaluate the safety, tolerability and the efficacy of~     riociguat compared with placebo in patients with SCD.~   "
32370|NCT02633384|"~     Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and~     exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to~     receive enteral nutrition for a long period of time, during which they require exclusive PN.~     In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions~     (ILE) used in PN may promote PNAC or protect against it depending on their composition.~     Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain~     triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation~     emulsions, the α-tocopherol content is higher than the gamma-tocopherol content, acting as~     an antioxidant, preventing lipid peroxidation.~      The incidence and severity of PNAC in term and near-term infants subjected to corrective~     surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or~     Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective~     from PNAC than Lipofundin®.~      Single-center, randomized, controlled and double-blinded trial on consecutive neonates~     admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective~     surgery of congenital anomaly of the digestive tract or indirectly affecting the digestive~     tract. Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum~     intervention: exclusive PN for at least 1 week.~      Main outcome: incidence of cholestasis (conjugated serum bilirubin >1 mg/dl [34 mmol/L]).~     Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and~     serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into~     account the correlation structure between measures in time. Crude and adjusted odds-ratios~     with corresponding 95% confidence intervals are calculated.~   "
32371|NCT02633371|"~     This is a single-center, prospective, open-label, outpatient pilot study evaluating the~     efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.~   "
32372|NCT02633358|"~     Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong~     inflammatory response, result in multiple organ failure, even death.~      While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6~     bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival~     rate and well cerebral performance.~   "
32373|NCT02633345|"~     The aim of the study is to investigate the effect of tablets containing probiotic candidate~     strains, on gingival inflammation and the levels of selected pro- and anti-inflammatory~     cytokines in gingival crevicular fluid (GCF). A secondary aim is to describe the effect of~     the tablets on the salivary microbiome. The null hypothesis is that the clinical~     measurements, levels of cytokines and microbial composition of saliva will not differ from~     baseline or between the study and control group.~      The study is planned as a double-blind; placebo controlled randomized trial with two~     parallel arms. The intervention period is planned to be 4 weeks.~      80 participants are planned to be enrolled after informed consent and then randomly~     allocated to either the probiotic group or the placebo group.~      The participants are randomly assigned to one of the study groups and given supply of either~     probiotic tablets or placebo tablets.~      The probiotic tablets contain Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2~     at a dose of 1 * 109 CFU(Colony Forming Units)/tablet. The participants will take two~     tablets a day for four weeks. Follow up registrations are conducted after two weeks, four~     weeks and six weeks.~      At each visit, saliva and GCF will be collected and then plaque index (PI)) and bleeding on~     probing (BOP) will be registered.~      All data will be processed with SPSS software (v 22.0; Chicago, Ill, USA). The follow-up~     values are compared to baseline within each group by Wilcoxon paired two-sided test and~     differences between groups are analyzed by Wilcoxon unpaired test. A p-value < 0.05 is~     considered statistical significant.~      The participants are fully covered by the patient insurance of The School of Dentistry which~     cover any damage to the trial participant during the study .There is no expected side~     effects to the treatment with probiotics. Probiotics are generally considered safe (GRAS:~     Generally Recognized As Safe) by The European Food Safety Authority (EFSA).~      The participants will not benefit directly from the treatment, but the knowledge gained from~     the study might contribute to the prevention of microbial derived illnesses in the mouth,~     e.g. caries and periodontitis, in the future. The sample collection does not cause any~     discomfort to the participants and the tablets have no known side effects. Therefore, the~     personal benefit of the participants corresponds to the minimal risk and discomfort to the~     participants.~   "
32374|NCT02633319|"~     The Malezi ne Kilimo Bora (Good Parenting and Farming in Kiswahili) Skilful Parenting and~     Agribusiness Child Abuse Prevention Study is a collaboration between the University of~     Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR).~     It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention~     implemented by Investing in Children and Our Societies (ICS), an international~     non-governmental organization (NGO) with extensive experience operating in rural Tanzania.~     The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting~     programmes' impact on the prevention of child maltreatment and improvement of child and~     family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240~     families).~   "
32375|NCT02633306|"~     Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant~     suffering and disability. This study will explore the ability of fMRI to identify patients~     with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.~      Specific Aims:~        1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without~          a definitive etiologic diagnosis.~        2. To estimate the rate of treatment success of transcranial stimulation of the primary~          motor cortex (M1) in these patients.~        3. To identify post-treatment MRI patterns that are associated with treatment success.~   "
46491|NCT02448485|"~     TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of~     minimally elevated troponin T plasma levels both in patients with asymptomatic and~     symtomatic aortic stenosis.~   "
32377|NCT02633280|"~     COPD is an inflammatory disease characterized by enhanced chronic airway and lung~     inflammatory responses to noxious agents (e.g. smoke, pollutants) and progressive airflow~     limitation. In COPD patients there is a spillover of peripheral lung inflammation into~     systemic circulation resulting in increased level of various inflammatory markers such as:~     IL-1β, IL-6, IL-8, and TNF-α.~      Diagnosis, now, is based on clinical evaluation and spirometry test and COPD treatment~     includes the use of LABA, LAMA and corticosteroids.~      To data no plasmatic marker able to identify the stage of COPD and the response to the~     treatment have been documented . The aim of this study is to evaluate in COPD patients the~     role of microRNA as predictive biomarker, of the disease in order to have a signature of~     miRs typically of COPD~   "
32378|NCT02633267|"~     Social anxiety disorder is a highly prevalent condition that interferes with employment.~     Prior research indicates that social anxiety disorder interferes with work attainment. This~     project involves a two-site randomized trial of a community-based cognitive-behavioral~     intervention to reduce social anxiety and improve employment outcomes among unemployed~     persons with social anxiety disorder.~   "
32379|NCT02633254|"~     So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided~     High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are~     known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes~     a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power~     sonications (heating points) will be used to occlude (part of) the feeding vessels of the~     fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to~     transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently,~     the bulk volume of the fibroid can be treated using the standard approach.~   "
32380|NCT02633241|"~     This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine~     can significantly decrease the dose of propofol (infusion) required for accomplishing an~     MRI.~   "
32381|NCT02633228|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.~   "
32382|NCT02633215|"~     This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled~     with functional motor training, to improve hand motor function in poorly recovered stroke~     patients. The central hypothesis is that stroke patients with severe motor deficit receiving~     hand nerve stimulation and intensive task-oriented therapy will have improved motor function~     compared to patients receiving sham nerve stimulation and task-oriented therapy.~   "
32383|NCT02633202|"~     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard~     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National~     Comprehensive Cancer Network guideline. However these recommendations were based on the~     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of~     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better~     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent~     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of~     IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to~     determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC~     patients treated with IMRT. Given the results of clinical studies mentioned above,the~     investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22,~     43~   "
32384|NCT02633189|"~     The purpose of this study is to test whether the combination of bevacizumab and erlotinib~     can prolong progression free survival as compared with erlotinib alone as first-line~     treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of~     EGFR.~   "
32385|NCT02633176|"~     This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus~     docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by~     concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal~     carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy~     and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive~     and prognostic factors for mNPC.~   "
32386|NCT02633163|"~     The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells~     (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus~     erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC~     infusion plus standard of care respond better than patients receiving placebo infusion plus~     standard of care.~   "
32387|NCT02633150|"~     Obesity, chronic disease, is a real public health problem because of its high prevalence but~     also because of the high risk of complications, including insulin resistance (IR) and type 2~     diabetes (T2D). The mechanisms involved in the development of IR are not well known.~     Oxidative stress and inflammation induced by food overload could be the initiators IR~     mechanisms in skeletal muscle, responsible for the use of nearly 80% glucose in response to~     insulin and therefore plays a major role in the regulation of glucose metabolism. Thus, an~     increase in ROS (Reactive Oxygen Species), markers of oxidative stress and chronic low-grade~     inflammation have been demonstrated in subjects with obesity, the latter decreasing in~     weight loss. Therapeutically, loosing weight is still very difficult these days, because of~     the complexity of this chronic disease. Thus, it is well established that restrictive diets~     to expose weight rebound, dramatic medically as in human terms for these patients. Support~     for physical activity is also difficult because of reduced mobility in patients, refer to~     the lack of motivation among some. Finally, investigators have no treatment~     against-obesity who have demonstrated a benefit / risk enough to be used routinely. It is~     therefore essential to seek other means of struggle against the IR, see help in weight loss.~      In parallel, it is well established that the consumption of certain antioxidants, including~     polyphenols (PP) grape as extracts and whole foods, modulates favorably several pathways~     responsible for the development of IR in cell models animals. The results of antioxidants~     supplementation in humans are few and controversial. However, most supplementation studies~     in human used a PP, Resveratrol at supra nutritional doses (ie not compatible with a~     balanced diet of fruits and vegetables). In a previous study, investigators tested the~     interest of a supplementation with red grape PP nutritional doses in healthy subjects with~     metabolic risk (overweight subjects and related to the first degree of T2DM patients) on IR~     hyperinsulinemic euglycemic clamp measured. During this study, the PP have prevented the~     central mechanisms of muscle IR that are oxidative stress and mitochondrial dysfunction~     induced by a load fructose.~      For this project, investigators propose to test the effect of a red grape PP supplementation~     at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant. This~     is a double-blind randomized placebo-controlled. This supplementation will be associated~     with a standard support for their obesity performed routinely in the Nutrition and Diabetes~     unit.~      Specific inclusion criteria: Female or male nondiabetic 50-65 years, BMI> 30 kg / m2 and~     with a HOMA> 3.~      The main objective is to test whether supplementation PP improves systemic insulin~     sensitivity (GIR: rate glucose infusion) measured by hyperinsulinemic-euglycemic clamp (gold~     standard for measuring insulin sensitivity) in insulin-resistant obese subjects.~      Secondary objectives are to:~        -  Test whether supplementation PP improves insulin sensitivity to tissue (fat and muscle)~          and compare the response to supplementation in these two tissues.~        -  Determining the cellular and molecular mechanisms involved in improving IR: regulation~          of inflammation, oxidative stress.~        -  Determine whether supplementation PP optimizes weight reduction compared to a standard~          single support.~      NSN: The number of subjects required was evaluated from our previous work (2013 Hokayem et~     al.) Whose main objective was to assess the impact of PD versus placebo in first degree~     relatives of patients with diabetes type 2. Under a bilateral alternative hypothesis of a~     nonparametric test (Mann-Whitney), 1: 1 ratio, a power of 80% and an alpha risk of 0.05, the~     number of subjects was estimated at 15 per group.~      Methodology: Anthropometric measurements, assessment of body composition (DEXA) system~     application characterization (metabolism, inflammation, oxidative stress, adipokines and~     insulin sensitivity: clamp hyperinsulinemic-euglycemic, lipopolysaccharides: LPS) / tissue~     characterization (biopsies of skeletal muscle and tissue adipose): insulin sensitivity,~     inflammation, oxidative stress, gene regulation (sirt1), mitochondrial activity / cell~     characterization (adipocyte precursor and muscle) insulin sensitivity, inflammation,~     oxidative stress, sirt1.~      Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional~     doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese~     patients, refer to optimize weight loss compared to a standardized management of obesity and~     determine the mechanisms involved.~   "
32388|NCT02633137|"~     The purpose of this study is to find out what effects, good and/or bad, the treatment~     including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has~     on the participant and their lymphoma.~   "
32389|NCT02633124|"~     This study evaluates the potential interest of a new multi-lumen infusion access device~     (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when~     administering injectable drugs in premature infants. This device will be compared to the~     standard infusion set of each center.~   "
32390|NCT02633111|"~     The purpose of this study is to determine whether a blood test can accurately detect whether~     if the participant's lymphoma has come back after completion of initial chemotherapy~     treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to~     see if MRD in blood samples can potentially replace CT scans after completion of~     chemotherapy in the future.~   "
32391|NCT02633098|"~     This study evaluates the safety and effectiveness of pre-operative artesunate given orally~     once a day for 14 days prior to surgery in patients with Stage II/III colorectal cancer.~      Artesunate is an established antimalarial drug with an excellent safety profile, is well~     tolerated and affordable. A number of laboratory studies and one small pilot clinical study~     in patients with colorectal cancer have shown that artesunate can reduce the activity of~     cancer cells.~      Two hundred patients diagnosed with operable colorectal cancer will be randomly allocated to~     receive oral artesunate 200mg daily or a matching placebo for 14 days prior to surgery.~     Patients will be followed up closely for 5 years to see if giving artesunate preoperatively~     reduces the risk of cancer returning after treatment.~   "
46549|NCT02447731|"~     Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added~     dead space.~   "
32392|NCT02633085|"~     The purpose of this study is to determine if there is a patient satisfaction preference of~     Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who~     are at a minimum two years post operative. Patient reported outcomes and expectations will~     be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a~     Mobile Bearing UKA in one or both knees.~   "
32393|NCT02633072|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.~   "
32394|NCT02633059|"~     This phase I/II trial studies the side effects and best dose of idasanutlin and ixazomib~     citrate when given together with dexamethasone in treating patients with multiple myeloma~     that has returned after a period of improvement. Drugs used in chemotherapy, such as~     idasanutlin and dexamethasone, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Ixazomib citrate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving idasanutlin, ixazomib citrate, and dexamethasone~     together may work better in treating patients with multiple myeloma.~   "
32395|NCT02633046|"~     Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository~     corticotropin injection) in adult subjects with idiopathic focal segmental~     glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant~     of, 1 or more previous immunosuppressive therapies.~   "
32396|NCT02633033|"~     This observational study aims to characterize the patient population and describe multiple~     sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with~     multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in~     standard practice in the United States.~   "
32397|NCT02633020|"~     Protocol CELIM-RCD-002 is designed to be a Phase 2a randomized, double-blind,~     placebo-controlled, parallel group study to evaluate the efficacy and safety of AMG 714 for~     the treatment of adult patients with Type II Refractory Celiac Disease (RCD-II), an in situ~     small bowel T cell lymphoma.~   "
32398|NCT02633007|"~     This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to~     evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.~   "
32399|NCT02632006|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of PIK-PD-1 Cells in the~     treatment of advanced Hepatocellular Carcinoma.~      Methods:~      This study designs a novel therapy using PIK-PD-1 cells. 40 patients with advanced~     Hepatocellular Carcinoma will be enrolled. They are randomly divided into dendritic~     cell-precision multiple antigen T cells (DC-PMAT) group and PIK-PD-1 cells group. Both~     DC-PMAT treatment and PIK-PD-1 cells treatment will be performed every 3 weeks with a total~     of three periods. The mail clinical indicators are Progression-Free-Survival and Overall~     Survival.~   "
32400|NCT02631993|"~     Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the~     anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not~     known whether the tumor-immunity is affected by photochemotherapy (psoralene~     photosensitization and ultraviolet light radiation) administered to attenuate graft-versus~     host disease (GVHD).~      The present study aim to investigate what happens to the GVL after photochemotherapy of~     aGVHD in a predominantly retrospective setting with 10-years follow-up after HSCT~   "
32401|NCT02631980|"~     Hepcifer Trial is designed to assess the value of iv iron administration immediately after~     liver surgery and consequences of inflammation on iron balance. Fifty patients will be~     randomized in two treatment groups. Patients will be assigned to receive either iv iron or~     placebo immediately after liver resection surgery. Biological inflammation parameters,~     hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1,~     3, 7, 15 and 30 after surgery.~   "
32402|NCT02631967|"~     Kono and collegues have described a new anastomotic technique to restore bowel contintuity~     after ileocecal resection for Crohn's disease (CD).~      This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the~     antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.~      In a retrospective study, the authors have shown that this anastomotic tecnique, when~     compared to stapled side-to-side anastomosis, significantly reduces the severity of~     endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic~     recurrence at 5 years after surgery.~      Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved~     by the stapled side-to-side anastomosis, within a prospective randomized study.~   "
32403|NCT02631954|"~     Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection~     200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in~     Healthy Volunteers~   "
32404|NCT02631941|"~     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in~     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence~     of the two products. Namely the study will compare the total systemic bioavailability (as an~     indicator of safety), and it will compare the pulmonary bioavailability (as a possible~     surrogate indicator of efficacy). This study will be performed in healthy subjects.~   "
32405|NCT02631928|"~     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new~     human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin,~     Huminsulin® Profil III. All participants will receive both study treatments on two separate~     dosing days.~   "
32406|NCT02631902|"~     Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population~     and is associated with a high cardiovascular mortality by coronary artery disease and~     cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are~     widely recommended to the control of type 2 diabetes and its complications. This study aims~     to analyse the effects of different community-based lifestyle programs (exercise or exercise~     plus dietary intervention) on health and well-being in patients with type 2 diabetes.~   "
32416|NCT02631772|"~     The predominant remaining questions for post-transplant treatment of HCV in the DAA era are~     whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a~     potential option to prevent long-term damage to the allograft.~      Our aim is to provide answers to these primary questions with our multicenter, prospective,~     randomized, open-label intent-to-treat phase IV study~   "
32407|NCT02631889|"~     Major lung resection is one of the most common procedures performed in thoracic surgery, but~     it may involve considerable bleeding and the occasional need for a transfusion and/or~     reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal~     adhesions and dissection can represent a challenge in patients who have undergone~     chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several~     intraoperative methods have been used to manage blood loss, including topical haemostatic~     agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a~     disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline~     solution that provides haemostatic sealing of soft tissue and bone and provides localized~     cooling without charring. Blood loss reduction has been previously described in several~     fields of surgery.~      The primary end-point of the proposed trial is to assess if the ability of Transcollation~     Technology in reducing the proportion of patients showing bleeding perioperatively within~     the setting of a prospective randomized controlled trial.~      The secondary end-point is to assess if Transcollation Technology is able to improve~     postoperative outcomes reducing the length of hospital stay.~   "
32408|NCT02631876|"~     This is a Phase 3, open label, randomized study designed to compare the safety and efficacy~     of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women~     with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or~     fallopian tube cancer.~   "
32409|NCT02631863|"~     This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid~     for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia~     (LSIL;CIN1).~   "
32410|NCT02631850|"~     The current proposal aims to conduct a multi-site randomized controlled trial comparing~     virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1)~     traditional clinic-based CI therapy of equal total active therapy duration and (2) a control~     group equating the dose of in-person therapy. Individuals with chronic stroke will be~     randomized to one of four different interventions: (1) traditional clinic-based CI therapy~     (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy~     (5 therapist/client contact hours in the clinic and 15 hours of independent game play at~     home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist~     contact via telerehabilitation (5 therapist/client contact hours in the clinic, 4 therapist~     contact hours via teleconference, and 15 hours of independent game play in the home), and~     (4) 5 hours of standard occupational therapy. After 6-month follow-up, individuals assigned~     to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone~     application of the rehabilitation game without additional therapist contact).~   "
32411|NCT02631837|"~     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and~     established total laparoscopic hysterectomy for successful removal of a non-prolapsed uterus~     in women due to undergo hysterectomy for benign gynecological pathology.~      Study design: Randomized controlled/single~     center/single-blinded/parallel-group/non-inferiority/efficacy trial.~      Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed~     uterus and a benign indication for hysterectomy.~      Randomization: Women will be randomly allocated to undergo one of two techniques for removal~     of the uterus immediately before surgery by using a computer generated randomization list.~     We will use stratified randomization according to the estimated uterine size on clinical~     examination.~      Intervention: Women will be treated by a surgeon who is not blinded to the treatment~     allocation and who is equally skilled in performing both techniques. In the intervention~     group a vNOTES technique will be used.~      Control: In the control group surgery will be done by a classical laparoscopic technique.~      Main study parameters/endpoints:~      Primary study outcome parameters: successful removal of the womb with the intended approach~     without conversion to an alternative approach.~      Secondary outcomes: the proportion of women admitted to the in-hospital ward for at least~     one night observation, based on their own preference; postoperative pain scores using a VAS~     (Visual Analogue Scale) measured between day 1 till 7 by the participating women following~     surgery and the total amount of analgesics used as described in the standardized pain~     treatment protocol from day 1 till 7; postoperative infection defined by lower abdominal~     pain with fever > 38°C and positive clinical signs or laboratory findings; per- or~     postoperative complications according to the Clavien- Dindo classification detected during~     the first six weeks of surgery; hospital readmission within 6 weeks following surgery;~     duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the~     participants at baseline, 3 and 6 months by self-reporting using a simple questionnaire and~     VAS (Visual Analogue Scale); sexual wellbeing recorded by the participants at baseline, 3~     and 6 months by SSFS (Short Sexual Functioning Scale); health-related quality of life, at~     baseline, at 3 and 6 months by self-reporting the EQ-5D-3L questionnaire; direct and~     indirect costs incurred up to 6 weeks after the hysterectomy associated with both~     procedures.~   "
32412|NCT02631824|"~     Randomized clinical trial to assess if the use of augmentation in the treatment of fragility~     intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged~     65 years or older 1 year after surgery~   "
32413|NCT02631811|"~     Several studies have shown that patients with acute leukemia have many symptoms during~     disease These symptoms decrease the quality of life and may even appear or worsen other~     symptoms such as depression Several studies point to the involvement of supportive care and~     palliative care is delayed in these patients The aim of this study is to evaluate the impact~     on the quality of life of an early and standardized involvement of a support / palliative~     care team for patients with acute leukemia in first relapse compared to a control group .~   "
32414|NCT02631798|"~     Previous with methylene blue suggested that oral administration may be superior to~     conventional spray catheters. The main advantages claimed were better staining due to longer~     exposure to the dye, more uniform staining due to normal position of the intestines (during~     conventional chromocolonoscopy, patients are lying on one side), and a quicker and more~     comfortable procedure for the patients and endoscopy personnel.~      Using food-grade dyes would enable higher dye loads and lower systemic side effects.~      Food grade dyes will be administered orally during preparation with KleanPrep (total amount~     of 4 liters) in patients undergoing screening colonoscopy.~      On day 1 patients will drink 3 l of the preparation solution, the last liter together with~     the last dose of dye will be administered 5 hours before scheduled colonoscopy.~      Primary endpoints:~        -  quality of mucosal staining of colon (assessed by questionnaire)~      Secondary endpoints:~        -  adenoma detection rate~        -  adverse events~        -  time of colonoscopy~   "
32415|NCT02631785|"~     The proposed research aims to isolate brain-based information-processing mechanisms~     implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.~      The study will focus on the therapeutic relevance of dysfunction in fear learning and~     extinction for treatment by examining the associations between brain functioning and~     response to exposure intervention in anxious children.~   "
32461|NCT02632422|"~     The purpose of this study is to determine how the nervous system controls leg muscles is~     important for walking in subjects following a spinal cord injury (SCI) and how they may be~     affected by brief periods of low oxygen inhalation over time.~   "
32417|NCT02631759|"~     Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in~     France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48~     hours). Currently, no urgent medical or surgical treatment has been shown to improve~     functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral~     haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical~     epileptic seizures (detected on the electroencephalogram (EEG) only) could be much more~     frequent (28 % to 40 %).~      Some studies have suggested that early repeated epileptic seizures may be associated with a~     worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may~     increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain~     tissue. Thus, prevention of early epileptic seizures may improve neurological outcome.~     However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and~     subclinical epileptic seizures has not been evaluated in the setting of intracerebral~     haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only~     when epileptic seizures occur.~      Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of~     systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute~     supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence~     of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter~     EEG.~      Secondary Objectives:This study also aims to assess:~      Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures,~     on the total duration of epileptic seizures continuously recorded on EEG, on the occurrence~     of some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours~     of diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12~     months) clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by~     the modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing~     the admission brain CT scan with the control CT scan performed at 72 hours, on the~     neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours~     , 1 month and 3 months and on the quality of life measured by the Stroke impact Scale at 3,~     6 and 12 months.~      Ä The frequency of side effects related to treatment with levetiracetam (anxiety and~     depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample~     Size: 104 patients will be recruited over 2 years.~   "
32418|NCT02632994|"~     This study is for patients who have participated in a previous study and who continue to~     receive benefit to have continued access to study drug and/or treatment.~   "
32419|NCT02632981|"~     Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of~     pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have~     reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32~     expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested~     that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study~     the investigators hypothesized that IL-32 levels may increase in the gingival crevicular~     fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls~     and these levels may decrease together with treatment.~   "
32420|NCT02632968|"~     Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and~     cost-effective technique for treatment of multiple gingival recession. This procedure~     involves no releasing incision, suturing or sharp dissections. It has been shown that the~     greater post-operative displacement of gingival margin may cause greater root coverage.~     Based on this hypothesis, a split mouth randomized controlled clinical trial was planned to~     compare the clinical outcome of pinhole surgical technique with and without the use of~     orthodontic buttons and sutures in the treatment of multiple gingival recessions.~   "
32421|NCT02632955|"~     Hemodialysis (HD) remains the most prevalent form of renal replacement therapy (RRT) for~     patients with End Stage Renal Disease (ESRD). Loss and dysfunction of vascular access is a~     significant contributor to morbidity in ESRD patients on HD. The National Kidney~     Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines suggest that all~     ESRD patients should initiate dialysis with a functioning permanent vascular access with~     arteriovenous fistulas (AVF) preferred over arteriovenous grafts (AVG). Central venous~     catheters (CVC) are the least preferred vascular access for HD due to the complications~     associated with them. Despite these recommendations, up to 80% patients start dialysis with~     a CVC. One of the reasons for low AVF rates is early fistula failure (EFF). The most~     important causes for EFF amenable to intervention is stenosis anywhere in the circuit.~     Endovascular approach has shown a high rate of technical success in the treatment of~     stenotic lesions related to HD arteriovenous access. Percutaneous balloon angioplasty (PBA)~     is considered the treatment of choice for these lesions. Despite good technical and~     immediate success PBA has poor long term outcomes with recurrence rates of 60-70% at 6~     months. One of the reasons could be the damage caused by angioplasty itself leading to~     intima-media rupture promoting the cascade of events leading to further development of neo~     intimal hyperplasia (NIH). Recently the use of covered stents at the time of angioplasty has~     shown better patency rates at 6 months but still not optimal. Lately the development of drug~     eluting stents and drug eluting balloons (DEB) have shown considerable advantage in clinical~     trials related to coronary and peripheral arterial disease angioplasty. In a randomized~     control trial, the researchers are planning to assess the efficacy of DEB angioplasty as~     compared to standard PBA in AVF's with EFF.~   "
32422|NCT02632942|"~     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in~     significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe~     economic burden on any health care system. Native arteriovenous fistula (AVF) is the~     preferred form of permanent dialysis access since it is associated with the best long term~     outcome as compared to other forms of dialysis access. Despite the clinical benefits, many~     patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF~     rates is early fistula failure (EFF). The two most important causes for EFF amenable to~     intervention are stenosis anywhere in the circuit and/or presence of accessory vein (av).~     Although management of stenosis is well established with relatively clear guidelines, the~     management of av lacks clear scientific approach. In a recent study researchers recommended~     a hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein~     obliteration. The purpose of this controlled, blinded, prospective trial is to assess the~     clinical utility of the HAQ criteria as compared to current recommendations for av~     obliteration.~   "
32423|NCT02632929|"~     The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and~     reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have~     diabetes and foot sores (also sometimes called ulcers or wounds).~   "
32424|NCT02632916|"~     The aim of this study is to acquire preliminary, pilot data over a 1-year period on the~     safety and efficacy of subcutaneous denosumab versus the current CHEO standard-of-care~     (intravenous zoledronic acid) for the treatment of osteoporosis in children. Both denosumab~     (1.0mg/kg) and zoledronic acid (0.025mg/kg) will be given as two doses separated by a six~     month interval (i.e. at baseline and 6 months), with follow-up to 1 year.~   "
32425|NCT02632903|"~     This study explores the effect of zoledronic acid on incident vertebral fractures and~     osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.~   "
32426|NCT02632890|"~     The purpose of the study is to determine a) if the implementation of abatacept (Orencia®)~     patient alert card (PAC) resulted in effective understanding of key safety messages and b)~     if the degree of understanding of key safety messages is associated with improved clinical~     and safety outcomes.~   "
32462|NCT02632409|"~     The purpose of this study is to determine the efficacy and safety of nivolumab versus~     placebo in participants who have undergone radical surgery for invasive urothelial cancer.~   "
32427|NCT02632877|"~     Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like~     neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene,~     diet and life style.~      DFU results as a complication in diabetic patients and it is the most common cause of~     non-traumatic foot amputation in people older than 50 years. Foot amputation decreases~     patients´ quality of life since only 33% of them will continue walking with the use of a~     prothesis.~      However, 30% of patients subjected to amputation will die in the first year after surgery~     and by the 5th year, post-surgery 50% of them will need the amputation of the remaining body~     extremity.~      According to the World Foundation for Diabetes, in Latin America there are 18 million people~     with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30~     million.~      Medical expenses for diabetic patients are calculated to be around 8,000 million dollars,~     annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10~     millions of diabetic patients.~      Amputation due to DFU complications has many social and economic implications. In Mexico in~     2011 diabetes mellitus complications were the principal cause of death in the institute of~     mexican social security (IMSS) population.~      On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an~     anti-inflammatory drug that promotes re-epithelization due to fibroblast stimulation,~     angiogenesis and vasculogenesis during tissue remodeling.~      According to this, the investigators believe that PFD could play an important role in DFU~     resolution and for this reason, the investigators consider necessary to analyze the efficacy~     of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed~     improvement in chronic skin ulcers in pilot studies.~      Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along~     with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient~     for and adequate control of diabetic patients.~      Then, it is important to develop efficient therapies for the treatment of DFU. In this~     context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated~     to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic~     parameters.~      Topical administration of ketanserin has showed beneficial effects in inflammation,~     granulation and epithelization.~      Since these two drugs have showed beneficial effects in tissue regeneration, the~     investigators believe it is important to compare their safety and efficacy for the treatment~     of DFU~   "
32428|NCT02632864|"~     The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial~     chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit~     in several randomized phase III trials, the benefit was modest.~      Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT~     techniques, showed favorable response rate with acceptable local control rate. Based on~     those promising results, RT was actively applied in HCC who are not indicated with surgery~     and/or radiofrequency ablation.~      Many researchers reported that there is a relationship between RT dose and tumor response~     rate. RT dose, however, is frequently limited because the complications (like radiation~     induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also~     closely related with higher exposed RT dose.~      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.~     The advantage of this dose distribution could be more highlighted in HCC management, because~     of the weakness and maintenance importance of liver function itself in HCC patients. In~     fact, the superior results of proton beam therapy in HCC were constantly reported in several~     groups as prospectively as well as retrospectively.~      In this background, the investigators planned the present study to evaluate the efficacy and~     safety of proton beam therapy in HCC patients who are not indicated with surgery and/or~     radiofrequency ablation (RFA).~   "
32429|NCT02632851|"~     This observational, non-interventional multicentric study compares the inhalation therapy on~     patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin~     inhalation solution and Pari NaCl (0.9%) inhalation solution~   "
32430|NCT02632838|"~     Monitoring and self-management are important components of effective chronic disease care~     and improved patient outcomes. With the rapid development of integration of mobile health~     technology (mHealth) into health care delivery services, mHealth intervention provides a~     great opportunity to improve the efficiency of chronic disease management. However, little~     is known about whether mHealth interventions can effectively impact the health and health~     care outcomes in underserved populations. This pilot study will assess the preliminary~     effectiveness of a mobile-based health intervention in an urban underserved community with a~     high incidence of hypertension. It is hypothesized that patients with hypertension will~     experience improved outcomes due to the use of a mHealth application compared with patients~     who are not using the application. The findings from this study will advance our~     understanding of the utility of mHealth interventions among underserved populations and~     generate evidence to support this new health care delivery approach in underserved urban~     communities.~      In this study, three hypotheses will be tested:~        1. Hypertension patients using the mHealth application exhibit a greater decrease in blood~          pressure and better maintenance over a 6-month period compared to those who receive~          standard care.~        2. Hypertension patients using the mHealth application will exhibit more effective~          self-management as compared to those who receive standard care.~        3. Utilizing the mHealth application helps nurses to monitor hypertension status more~          effectively than monitoring hypertension status without the mHealth application.~   "
32431|NCT02632825|"~     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and~     often produce similar clinical outcomes. It has been shown in adults that NHF produce~     different effects on ventilation during wakefulness and sleep. There is no physiological~     data on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake~     status.~   "
32432|NCT02632812|"~     This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if~     rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24~     participants (12 per treatment group), male or female, aged 18 years-old and above.~      Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus~     naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily,~     for seven days, in reduction of gastric events caused by naproxen. Secondary objective is to~     evaluate safety and tolerability of rebamipide after multiple administrations.~      Participants will receive either rebamipide + naproxen or placebo + naproxen, as above,~     during 7 consecutive days, which will be accompanied by a follow-up visit.~      Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach~     biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool~     will be performed, before and after treatment.~      From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis~     will be performed.~   "
32433|NCT02632799|"~     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and~     often produce similar clinical outcomes. The aim of the study was to investigate airway~     pressure during NHF and CPAP in neonates.~   "
32746|NCT02628600|"~     This open-label safety extension study will assess the safety and tolerability of once daily~     dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in~     subjects with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium~     complex (MAC) who are refractory to therapy in Study INS-212.~   "
32435|NCT02632773|"~     Improving social communication outcomes for children with autism spectrum disorders (ASD)~     has important public health implications. The proposed research is a randomized controlled~     trial of 108 children with ASD that examines how specific parent characteristics influence~     outcomes of two different parent-mediated language interventions. Evaluating effective~     language intervention strategies for children with ASD supports NIDCD's mission of~     behavioral research aimed to remediate the disordered process of language development in~     children with ASD.~   "
32436|NCT02632760|"~     This randomised double-blind, controlled phase IV trial will compare the efficacy, safety~     and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before~     elective cardiac surgery.~   "
32437|NCT02632747|"~     This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design~     trial with empagliflozin compared to placebo that is added to open-label ramipril in~     patients with type 1 diabetes.~   "
32438|NCT02632734|"~     Normally, dentists do not graft the socket after extraction of teeth. When they do graft~     they use particulate graft devices. The purpose of this study is to examine whether coral~     particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will~     preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth~     extraction. The coral grafting devices are processed from Porites corals grown in aquariums,~     under controlled environment. The devices are cleansed and sterilized by gamma irradiation.~     The measurements during follow ups will be performed from CT x rays and measurements by~     caliber and models.The width and height measurements from follow up x rays and models. The~     study will be performed on 10 patients, that two parallel teeth are diagnosed to be~     extracted, in same patient.The data will be analysed for bone loss and compared to previous~     published studies. Also comparison between two devices will be performed.~   "
32439|NCT02632721|"~     Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose~     for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics~     and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary~     objective is to collect additional data on safety, pharmacokinetics and efficacy and to~     define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.~      Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI~     836858 in combination with decitabine compared to decitabine monotherapy.~   "
32440|NCT02632708|"~     The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120~     and AG-221 when given in combination with standard AML induction and consolidation therapy.~     The study plans to evaluate 1 dose level of AG-120 in subjects with an IDH1 mutation and 1~     dose level of AG-221 in subjects with an IDH2 mutation. AG-120 or AG-221 will be~     administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or~     idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or~     cytarabine). After consolidation therapy, subjects may continue on to maintenance therapy~     and receive daily treatment of AG-120 or AG-221 for up to 1 year from Day 1 of the first~     induction cycle, or until relapse, development of an unacceptable toxicity, or hematopoietic~     stem cell transplant (HSCT).~   "
32441|NCT02632695|"~     The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health~     (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill,~     population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled~     accelerometer and tracking device (BEAT) worn on the foot during a progressive and~     evidence-based non-exertive leg conditioning activities for lower leg function (CALF)~     captures minute foot movements and sends the data to a Smartphone. This six-week feasibility~     study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote~     patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on~     functional outcomes in a very low fitness population.~   "
32442|NCT02632682|"~     Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with~     Conventional Histology for the Identification of Specialized Intestinal Metaplasia~   "
32443|NCT02632669|"~     This clinical study will evaluate side effects, quality of life and cancer control in~     patients with prostate cancer diagnosed on only one side of the prostate gland.~      The diagnosis of unilateral prostate cancer will be made by means of a prostate~     transperineal template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI).~      Patients will be treated with low dose rate brachytherapy, using permanent iodine seed~     implants.Treatment will be limited to the side of the gland where the cancer has been~     diagnosed and is therefore called focal brachytherapy.~      Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland~     prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal~     approach, the side effects will be evaluated by means of patient questionnaires.These will~     be repeated at various intervals after treatment.The results will be compared to the same~     questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore~     an assessment can be made whether focal therapy produces fewer side effects than whole gland~     brachytherapy.The observation period will last for two years after treatment. A biopsy and~     mpMRI will be repeated after two years to evaluate prostate cancer control.~   "
32444|NCT02632656|"~     The primary objective is to measure the association between extracellular RNA (ex-RNA)~     levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1)~     cardiac remodeling and (2) cardiovascular events. The investigators will follow patients~     during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma,~     and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.~   "
32445|NCT02632643|"~     The study aims to demonstrate the efficacy of the sensorimotor approach developed by A.~     Piron (taught to the patient in three sessions) regarding three parameters related to TMD:~     facial pain, functional incapacities and hypertonia.~      The subjects in the study are 18 to 77 years old and present the following conditions: a TMD~     disorder caused or aggravated by hypertonia and responsible for cervico-maxillo-facial pain~     and/or a functional incapacity in the last 30 days.~   "
32463|NCT02632396|"~     This phase I/II trial studies the side effects and best dose of ixazomib citrate (ixazomib)~     and to see how well it works after stem cell transplant in treating patients with mantle~     cell lymphoma that are no longer showing signs or symptoms of cancer. Ixazomib may stop the~     growth of cancer cell by blocking enzymes needed for cell growth. Giving ixazomib after~     transplant may help prevent the cancer from coming back.~   "
32446|NCT02632630|"~     Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than~     well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition~     is common and is associated with extremely poor outcomes, it is neglected and undertreated.~     This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical~     patients, and then provide nutritional supplementation in hospital and after discharge for~     28 days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein~     will be used in addition to oral nutritional supplementation.~   "
32447|NCT02632617|"~     Preoperative detection of combined coronary artery disease by invasive coronary angiography~     (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology~     (ACC) guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for~     heart valve surgery, but the low incident rate of coronary artery disease implied guidelines~     for the vast majority who ultimately will not undergo revascularization. Computed tomography~     angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following~     advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study~     is to evaluate the feasibility of computed tomography, instead of conventional invasive~     coronary angiography in evaluating coronary artery lesion prior to the heart valvular~     operation.~   "
32448|NCT02632604|"~     The purpose of this study is to investigate the effect of a neuroplasticity-based~     computerized cognitive training for the elderly~   "
32449|NCT02632578|"~     The aims of this study are:~        1. to investigate if HIV infection alters the antibody responses to influenza and~        2. to assess the ability of licensed influenza vaccine to induce functional~          non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.~   "
32450|NCT02632565|"~     In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and~     saline injection on pain, stiffness and physical function in patients with osteoarthritis.~   "
32451|NCT02632552|"~     Transition from hospital to home places patients in jeopardy of adverse events and increases~     their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S.~     adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent~     significant burdens for the VHA healthcare system. Care transitions can be supported through~     multi-component interventions, but are costly to implement. Virtual nurses provide an~     effective medium for explaining health concepts to patients, and previous work indicates~     patients find virtual nurses acceptable. The investigators will implement and evaluate a~     virtual nurse intervention to provide automated, tailored, and timely support to Veterans~     transitioning from hospital to home. As effective care transition interventions incorporate~     both inpatient and outpatient components, the virtual nurse will first engage with patient~     onscreen during their inpatient stay and then via text message post-discharge. This project~     has the potential to improve the care transition experience for patients, caregivers and~     healthcare providers.~   "
32452|NCT02632539|"~     Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients~     who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic~     space is a well-proven cause of VAP. Investigators invented a manual method with high-flow~     air produced by resuscitator to impinge secretion from the subglottic space to oral cavity.~     Investigators want to compare it with conventional method which uses a special intubation~     tube with an independent dorsal lumen to suction subglottic secretion.~   "
32453|NCT02632526|"~     This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single~     and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to~     assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy~     male subjects~   "
32454|NCT02632513|"~     The aim of this study was to compare the success after endodontic treatment performed with~     or without continuous ultrasonic irrigation.~      70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were~     randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and~     syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both~     groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step~     back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after~     each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17%~     EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium~     hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous~     ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium~     hydroxide was given and patient was recalled after one week and canals were obturated with~     the Gutta Percha. Immediate postoperative radiograph was then taken, followed by radiographs~     at 3, 6, 9 and 12 months.~   "
32455|NCT02632500|"~     The aim of the study is to verify whether the inclusion of breaks of different frequency and~     duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest~     compressions quality during an 8-minutes scenario.~   "
32456|NCT02632487|"~     This study will evaluate the feasibility and efficacy of combining a traditional, structured~     exercise intervention with an innovative intervention designed to decrease sedentary~     behavior and increase non-exercise physical activity (NEPA).~   "
32457|NCT02632474|"~     The purpose of this study is to determine efficacy of the combination of low dose of~     Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.~   "
32458|NCT02632461|"~     The purpose of the study is to test the effectiveness of two different weight loss~     interventions. Both of these interventions will provide weight loss information through~     twice weekly audio podcasts. In addition to the podcasts, participants will be asked to~     track their diet using either a wearable device on their wrist or through an app on their~     smartphone.~   "
32459|NCT02632448|"~     The main purpose of this two-part study is to evaluate the safety and efficacy of the study~     drug known as LY2880070 in participants with advanced or metastatic solid tumors.~   "
32460|NCT02632435|"~     In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel~     method to allow comparisons of established standard of care vascular access strategies using~     the integrated consent model as part of a pragmatic clinical trial. The investigator~     wishes to address a non-pharmacologic issue regarding standard of care vascular access~     devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously~     implanted devices (PORTs).~   "
32465|NCT02632370|"~     In support of the US marketing application for 5-ALA, this single arm trial is being~     conducted to establish the efficacy and safety of Gliolan (5-ALA) in patients with newly~     diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan (5-ALA), as~     an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates~     with malignant histopathology. The primary objective in this single arm study is to define~     the positive predictive value (PPV) of Gliolan-induced PPIX fluorescence for malignant tumor~     at the time of initial resection and first use of FGS by taking a biopsy of tissue~     presenting with red fluorescence when observed during the course of resection of new or~     recurrent malignant gliomas. The functionality and performance reliability of the blue light~     excitation microscope platforms will be assessed.~   "
32466|NCT02632357|"~     Study Design: Longitudinal Experimental Study~      Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and~     cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing~     model based on Least Square Approximation.~      Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and~     brachial plexus displacement within their interface structures. No studies were conducted~     about ULNTT1 and cervico-thoracic spine motion patterns relationship.~      Methods: 12 subjects with ULNTT1 asymmetry > 10° (AS group) and 11 subjects with ULNTT1~     symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be~     analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one~     patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be~     collected with motion-capturing technique and data will be analyzed with Least Square~     Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will~     undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility~     will be so re-evaluated with same methods.~   "
32467|NCT02632344|"~     This research study is evaluating an immune modulatory agent as a possible treatment for~     patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving~     the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the~     treating agent.~   "
32468|NCT02632331|"~     The objective of this study is to evaluate the effect of food on the pharmacokinetics and~     safety after administration of ASP8825 in healthy non-elderly adult male subjects.~   "
32469|NCT02632318|"~     One of the most physiologically demanding things that older people do every day is to get up~     in the morning. After spending a night laying flat, where the blood distributes evenly~     across the body, when they stand in the morning (and the blood rushes to their feet), their~     cardiovascular system may not be able to compensate and maintain blood flow to the brain.~     This phenomenon is known as orthostatic or postural hypotension. The investigators have~     found in a group of young individuals that use of a dawn-simulation light that gradually~     wakes the brain is able to increase cardiovascular tone prior to arising. The goal of this~     experiment is to determine whether this dawn simulation light is able to increase~     cardiovascular tone in older adults such that they would have reduced or absent postural~     hypotension when they awaken in the morning. This would greatly reduce the risks of falls~     and their associated morbidities in older adults.~   "
32470|NCT02632305|"~     There is increasing evidence that there is a large degree of pathologic homology between the~     pancreas and biliary tract. Indeed, the biliary tract has been referred to as an incomplete~     pancreas and embryologically the two originate from the same structure. It is thus~     plausible that oncogenesis in the pancreas and biliary tract are related and that pancreas~     and biliary cancers have reciprocal effective treatment strategies.~      To date, the only chemotherapeutic agents effective in advanced biliary tract tumors is the~     combination of gemcitabine and cisplatin. Known and approved therapies for advanced pancreas~     cancer include single agent gemcitabine, the four drug combination of FOLFIRINOX~     (5-fluorouracil, leucovorin, oxaliplatin, and irinotecan), the questionable limited benefit~     of inhibiting the epidermal growth factor receptor pathway, and most recently the~     combination of gemcitabine and nab-paclitaxel.~      Based on promising results in pancreas cancer, investigators hypothesize nab-paclitaxel in~     combination with gemcitabine + cisplatin will be an effective cytotoxic combination in BTC~     treatment.~   "
32471|NCT02632292|"~     Prospective, randomized, controlled, multicenter, open-label study to compare~     everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients~     with diabetes mellitus.~   "
32472|NCT02632279|"~     The purpose of this study is to assess the effect of tryptophan depletion on mood and~     behavior in Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of~     the subthalamic nucleus (STN). By doing this, the investigators hope to be able to identify~     risk factors for and mechanisms underlying psychiatric side effects of STN DBS. The study~     will be an intervention study with a placebo controlled, randomized cross-over design.~   "
32473|NCT02632266|"~     The purpose of this study is for the researchers to examine the safety and efficacy of~     liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human~     milk fortifier.~   "
32474|NCT02632253|"~     Patients with congenital heart disease have long been discouraged from participating in~     physical exercise which has led to impaired exercise capacity in this population. Since low~     physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization~     and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance~     training has been recommended recently to improve exercise capacity. The aim of this study~     is to compare two types of training, namely high-intensity interval training (HIIT) and~     moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity~     without adverse effects on heart structure, function and rhythm in the setting of a 12-week~     outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving~     the right and/or left ventricles. Primary endpoint will be change in exercise capacity~     (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the~     right or left ventricles as well as vascular function.~      Patients with GUCH and reduced function of the right ventricle will be recruited and~     informed about the study within the first two weeks of CR. At the end of week 3 of the CR~     with supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes~     place.~      MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38~     min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax),~     interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one~     additional endurance activity per week in their own time with a duration of 30-60 min at~     moderate intensity monitored by their smart phone.~      Change in peak oxygen uptake as well as maximal exercise capacity at the end of an~     incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular~     function will be assessed at the same time. Volumes and function of the right and left~     ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into~     the study and at completion of the intervention. Furthermore, laboratory markers for heart~     failure as well as occurrence of irregular fast heart beats will be assessed.~   "
34354|NCT02607410|"~     To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin ,~     with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea~     plus biguanide: effects on beta cell function and on metabolic profile.~   "
32477|NCT02632214|"~     The aim of this study is to evaluate cerebral asymmetry for face processing in a group of~     profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To~     this end, we present chimeric faces (faces split into different halves), entire faces, or~     faces presented in divided visual field, and subjects perform a gender categorization task~     while lying in a fMRI scanner.~      It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in~     comparison with hearing participants.~   "
32478|NCT02632201|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the~     treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.~      Methods:~      This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with~     liver metastasis from gastric cancer will be enrolled. They are randomly divided into~     dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group.~     Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a~     total of three periods. The mail clinical indicators are Progression-Free-Survival and~     Overall Survival.~   "
32479|NCT02632188|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of radical surgery combined~     with dendritic cell-precision multiple antigen T cells in reducing the recurrence and~     metastasis of liver cancer~      Methods:~      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.~     60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly~     divided into postoperative routine therapy group and dendritic cell-precision multiple~     antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision~     multiple antigen T cells treatments will be performed every 3 weeks with a total of three~     periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.~   "
32480|NCT02632175|"~     This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects~     with ulcerative colitis.~   "
32481|NCT02632162|"~     Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after~     cardiac surgery will be screened for SDB with the ApnoeLink device at the beginning of~     cardiac Rehabilitation and then after 3 weeks and 3 months.~   "
32482|NCT02632149|"~     The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve~     stimulatior in children with Lennox-Gastaut Syndrome.~   "
32483|NCT02632136|"~     A newly developed technique of TAP block solely performed by surgeons will be used for~     postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal~     hernia repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better~     than the periportal wound infiltration in controlling the postoperative pain.~   "
32484|NCT02632123|"~     Idiopathic pulmonary fibrosis (IPF) is a progressing scarring disease of the lungs with an~     average survival of only 30-36 months since the time of diagnosis. The clinical course of~     IPF is highly variable, with some patients remaining stable for a prolonged period of time,~     even in the absence of medical treatment, while others experience rapid and relentless~     progression. In some cases, the clinical course consists of a stepwise rather than steady~     decline, with periods of stability alternating with acute respiratory worsening. The~     variability in clinical course makes it challenging to define prognosis in these patients~     and, importantly, to determine the right time window for lung transplantation (LTx)~     referral, listing and priority status on the waiting list.~      The risk stratification score (RISE) is a new staging system for IPF based on the MRC~     dyspnea score, on physiology variables (pulmonary function tests) captured in the Composite~     Physiologic Index (CPI), and on the 6-minute walk distance. RISE showed to predict survival~     in newly diagnosed patients with IPF better than any other individual clinical, functional~     or radiographic variable. RISE also predicted survival on the waiting list in patients~     assessed and listed for LTx.~   "
32485|NCT02632110|"~     The purpose of this study is to determine the viability of microneedle lesion preparation~     (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis~     (AK) field on the face.~   "
32486|NCT02632097|"~     This is a prospective, randomized double-blinded study to find out if mesh fixation with~     n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with~     sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our~     hypothesis is that glue fixation is safe, simple and fast method compared to conventional~     Lichtenstein technique.~   "
32487|NCT02632084|"~     A study to followup patients that have previously been treated for pituitary tumours with~     either photodynamic therapy or placebo in a previous trial. The study aims to determine~     whether photodynamic therapy has any long term effect on tumour size, visual fields or~     endocrinological function.~   "
32488|NCT02632071|"~     This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety~     and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215~     in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its~     potential synergy with taxanes, these data support the rationale for testing the ability of~     ACY-1215 to improve the response rate for patients with metastatic breast cancer in~     combination with standard taxane chemotherapy.~   "
32489|NCT02632058|"~     Tinnitus is the acoustic perception of sound without any physical source. It is estimated~     that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation~     in all aspects of daily life of the affected.~      There is currently no evidence for a successful treatment of tinnitus. While one treatment~     approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment~     aspect in our setting involved cognitive behavioural therapy.~   "
32490|NCT02632045|"~     This is a randomize trial for patients with metastatic HR-positive HER2-negative breast~     cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either~     palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib. The~     purpose of the trial is to determine whether there is continued benefit for patients to~     remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib~     and palbociclib have a similar toxicity and drug profile and mechanism of action, we feel~     that it is appropriate for patients to receive either drug with an aromatase inhibitor prior~     to randomization.~   "
34451|NCT02606084|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of~     intranasally administered esketamine in participants with impaired renal function when~     compared to participants with normal renal function.~   "
32491|NCT02632032|"~     Therapeutic education is central to the management of diabetes, especially in children and~     adolescents. Camps represent an ideal environment for education. During camps, the campers~     receive both theoretical and practical information intended to improve their understanding~     and self-management of diabetes. The metabolic impact of diabetes camp is little known among~     children and adolescents living with type 1 diabetes in sub-Saharan Africa. The aimed of~     this study was to assess the changes in glycemic control and insulin doses in a group of~     children and adolescents living with type 1 diabetes in Cameroon during and after camp.~   "
32492|NCT02632019|"~     Objectives:~      The purpose of this study is to evaluate the safety and prognosis of dendritic~     cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant~     tumor.~      Methods:~      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.~     40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic~     cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine~     treatments will be performed once a week with a total of six times. Dendritic cell-precision~     T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a~     total of six times before 60 days prior to the start of drawing blood. Dendritic~     cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The~     mail clinical indicators are Progression-Free-Survival and Overall Survival.~   "
32493|NCT02631746|"~     This phase II trial studies how well nivolumab works in treating patients with human T-cell~     leukemia virus (HTLV)-associated T-cell leukemia/lymphoma. Nivolumab is an antibody, which~     is a type of blood protein that tags infected cells and other harmful agents. Nivolumab~     works against a protein called programmed cell death (PD)-1 and may help the body destroy~     cancer cells by helping the immune system to keep fighting cancer.~   "
32494|NCT02631733|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with liposomal irinotecan in treating patients with solid tumors that have spread to other~     parts of the body (metastatic) or cannot be removed by surgery. Liposomal irinotecan and~     veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
32495|NCT02631720|"~     While many patients experience benefits from transplant, complications such as infections~     and lung rejection may affect long term survival and quality of life. In this study doctors~     are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is~     thought to be chronic rejection of the lung by the immune system and is the leading cause of~     death after lung transplantation.~      The purpose of this study is to help doctors determine:~        -  why some people get CLAD and others do not~        -  how patients who get CLAD do after CLAD is diagnosed~        -  how CLAD may affect quality of life~   "
32496|NCT02631707|"~     All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to~     surgery. It is unknown what the most effective diet is to lose weight, while still~     preserving muscle mass. The diet must also be acceptable and adhered to by patients. The aim~     of this study is to find out if a diet that is higher in protein and lower in carbohydrate~     than the standard Ministry of Health guidelines will have a greater effect on weight loss,~     preservation of lean muscle mass, surgical recovery score, adherence and acceptability.~   "
32497|NCT02631694|"~     Animal and human fear conditioning studies have repeatedly shown that administering~     propranolol before or after retrieval of a previously acquired fear results in an~     elimination of the fear expression. This approach, known as disruption of fear memory~     reconsolidation, is a promising new avenue for treating anxiety disorders. The present study~     aims to test its efficacy in patients with panic disorder.~   "
32498|NCT02631681|"~     Exercise intervention for men with prostate cancer on androgen deprivation therapy.~   "
32499|NCT02631668|"~     IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia,~     the doctor will prescribe ferrous succinate with or without vitamin C according to their own~     preferences. In theory, only the divalent iron can be absorbed in duodenum and upper~     jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree~     of acidity in the intestine, and then promotes the absorption of iron. In current clinical~     practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of~     vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and~     safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The~     dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to~     patients who meet the inclusion criteria, and these patients are followed up every two~     weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of~     anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the~     incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include~     vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C~     can increase the absorption of iron and accelerate the recovery of anemia, it also increases~     incidence of gastrointestinal adverse events because of increased iron absorption at the~     same time.~   "
32500|NCT02631655|"~     18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management~     of patients with high-grade gliomas in order to provide medico-economic justification for~     its use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management~     decisions for patients with brain tumors (Walter JNM 2012). However, this study comprised 58~     patients, combined primary and recurring tumors, and was based on questionnaires sent out to~     referring physicians. A targeted study is needed, therefore, to make a prospective~     multicenter assessment of the contribution of this technique in the context of high-grade~     glial tumors and neurooncology MCCs.~   "
32501|NCT02631642|"~     The purpose of this study is to evaluate the safety and tolerability of a single dose of~     HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses~     of HMPL-689 in healthy volunteers~   "
32502|NCT02631629|"~     This project aims at proving the efficacy and safety of food based solutions to prevent~     vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in~     Denmark.~   "
32757|NCT02628288|"~     Comparison of healing responses after treatment of complex bifurcation lesions with a~     dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System +~     Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb~     BVS: an optical coherence tomography (OCT) analysis.~   "
32503|NCT02631616|"~     Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of~     neuroendocrine differentiation (NED). Recently the investigators initiated a research~     project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine~     tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the~     tracer in bone metastases was found. It has been shown that monthly injections of~     Somatostatin lengthen overall survival in patients with NET. The purpose of the current~     project is to examine the ability of Somatostatin to stabilize or possibly reverse~     metastases in patients with CRPC that express high level of somatostatin receptors in~     68Ga-DOTATET PET/CT.~      Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT.~     Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will~     be considered eligible for the study. These patients will be evaluated biochemically and~     clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical,~     biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months~     of treatment. Responding patients (stabilization or decrease in the number and SUV of~     metastases) will be subjected to continued therapy until progression.~   "
32504|NCT02631603|"~     Stop exogenous allergic alveolitis (EAA) in childhood: healthy into adulthood - a~     randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone~     treatment and course of disease.~      The hypothesis of the study is that the treatment with placebo will not be inferior in terms~     of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6~     months treatment.~   "
32505|NCT02631590|"~     The purpose of this study is to see if an experimental drug, called copanlisib is effective~     and safe in treating adult participants with cholangiocarcinoma, when used in combination~     with gemcitabine and cisplatin.~   "
32506|NCT02631577|"~     This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of~     induction treatment consisting of atezolizumab in combination with obinutuzumab plus~     lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by~     maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who~     achieve a complete response (CR), a partial response (PR), or stable disease at end of~     induction.~   "
32507|NCT02631564|"~     The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan~     and raltitrexed with or without embolization by lipiodol or microspheres are effective in~     the treatment of refratory liver metastasis from colorectal cancer.~   "
32508|NCT02631551|"~     Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to~     individual monotherapies (comparators) as well as the efficacy of these monotherapies~     (comparators) versus placebo NS over 14 days of study treatment~   "
32509|NCT02631538|"~     This study is a multi-national, multi-center, double-blind (sponsor open), randomized,~     placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to~     understand the safety and tolerability profile of belimumab/ rituximab co-administration and~     of belimumab monotherapy; and to evaluate whether either co-administration therapy or~     belimumab monotherapy has a substantive effect on disease activity.~      This study will consist screening period, double blind treatment period, a general follow-up~     period and individualized follow-up period. Approximately 70 subjects will be recruited into~     the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four~     treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and~     rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24,~     interim analyses and sample size re-estimation will be conducted. The total number of~     subjects randomized may increase following sample size re-estimation up to a maximum of 120~     recruited into the study.~      Subjects in all arms will receive investigational product (IP) until Week 52 (completion of~     the treatment phase). All subjects will enter a 16-week general follow-up period after the~     Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the~     treatment phase visits prior to Week 52.~      After completing the general follow-up period, subjects with cluster of differentiation~     (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of~     baseline, if baseline value was below lower limit of normal [LLN]) will enter an~     individualized safety follow-up phase and return to the clinic for visits every 12 weeks~     with monthly calls between visits to evaluate subjects for any serious adverse events (SAEs)~     related to IP or study participation, fatal SAEs, and designated adverse event of special~     interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and~     to check concomitant medications.~      The total duration of participation of a subject in this study will be approximately up to a~     maximum of 2 years (i.e., up to Week 104).~   "
32510|NCT02631525|"~     Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative~     recovery than remifentanil-propofol.~   "
32511|NCT02631512|"~     The aim of the current study is to support the performance and safety of Woulgan® in the~     treatment of diabetic foot ulcer in comparison with the commercially available hydrogel~     Intrasite. Healing and untoward medical events to be evaluated.~   "
32512|NCT02631499|"~     This study is designed to prospectively evaluate whether post-hepatectomy adjuvant~     transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in~     HCC patients with preoperative CTC ≥2.~   "
32513|NCT02631486|"~     Shoulder pain is among the most common musculoskeletal complaints, leading to high number of~     General Practioners consultations in the United Kingdom. On the top list of the disorders~     causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator~     cuff tears is multifactorial and is likely to be a combination of age-related degenerative~     changes and trauma during life. It is present in approximately 25% of individuals in their~     60s and 50% of individuals in their 80s and have been shown to start developing during the~     40s. To recover functional status of this patients group, surgical repair is often~     recommended, but for optimal results the rehabilitation is of great importance and must be~     adequately planned. After surgery a period of movement restriction is followed, however, the~     optimal time of immobilisation is unknown. As a common practice, patients use a sling for~     six weeks and avoid any activities with the affected shoulder. This period is important to~     protect the tendon, allow good healing and to possibly prevent re-tear episodes. Although,~     the delayed motion may increase the risk of postoperative shoulder stiffness, muscle atrophy~     and potentially delay improvement of functionality. Based on the available evidence, it is~     difficult to make a clinical decision for a well-programmed rehabilitation regime and~     establish the most favourable postoperative time to start it. Moreover, it is not clear if~     early mobilisation will benefit more severe stages as published studies have methodological~     flaws that compromises the clinical decision for patients with higher commitments. The~     question whether early mobilisation application is beneficial is of high importance as the~     results will not just help improving patients quality of life, but also may reduce costs as~     further complication may be avoided.~   "
32514|NCT02631473|"~     This study is an open-label, prospective pharmacokinetic study investigating two~     antiretroviral agents in parallel and employing an adaptive design with two stages, whereby~     the results obtained in the primary stage inform the doses selected for investigation in the~     secondary stage~   "
32515|NCT02631460|"~     This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with~     pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth~     factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer~     (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC~     and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned~     to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the~     curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance~     until disease progression: pemetrexed or S1. The primary end point of this non-inferiority~     study was progression free survival（PFS）~   "
32516|NCT02631447|"~     To evaluate the best sequencing approach with the combination of target agents (LGX818 plus~     MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in~     patients with metastatic melanoma and BRAF V600 mutation.~   "
32517|NCT02631434|"~     Comparison between sit-to-stand test and six minutes walking test in chronic obstructive~     pulmonary disease patients~   "
32518|NCT02631421|"~     Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial~     hypertension (PAH). No RV-specific therapies are available, in part because the underlying~     mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty~     acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV~     adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis~     that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The~     investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH~     patients in comparison with patients with pulmonary venous hypertension and no evidence of~     pulmonary hypertension. The investigators will also correlate metabolites with concurrent~     measurement of right ventricular function.~   "
32519|NCT02631408|"~     Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in~     spinal fusion surgery. The powder will be locally administered into to the wound cavity~     before wound closure.~      Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical~     site infections~   "
32520|NCT02631395|"~     Very little is known about the potential for preventing the prevalence of shoulder~     complaints in handball players, particularly younger players. The aim of this study is to~     evaluate the effect of a shoulder training program on shoulder pain during a season of team~     handball.~   "
32521|NCT02631382|"~     Randomized clinical trial to compare the effectiveness and safety of double (traditional)~     versus single (Asian) cupping techniques in chronic low back pain.~   "
32522|NCT02631369|"~     Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm~     by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment~     of the influence of measuring with or without eye tracker.~      Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in~     healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg~     Spectralis~   "
32523|NCT02631356|"~     The study is to investigate the effect of succinylated gelatin on the blood viscosity and~     oxygen delivery in patients during surgeries, so as to have a better understanding of the~     safety in the use of succinylated gelatin for surgical patients.~   "
32524|NCT02631343|"~     While newborn and child survival remains a priority, optimal development of survivors is~     receiving increasing attention. Interventions that impact both survival and development~     should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and~     potentially neurodevelopment, in preterm and low birth weight infants in hospital settings~     but its coverage remains low. Innovation is required to allow the community-based delivery~     of KMC by front-line workers. This could greatly accelerate scale up and sustainability of~     this intervention in low resource settings.~      The proposed randomized trial is planned in a setting where 40% of births take place at~     home. Early discharge (as early as within 12 hours of birth) is common for facility births,~     often at the request of families for social and cultural reasons. Many of the hospitals do~     not have incubators for the care of very small babies.~   "
32525|NCT02631330|"~     Practice guidelines in caring for the geriatric population recommend performing an annual~     screening of falls . However, one of the problems that interfere with fall prevention~     programs is the lack of importance accorded to health professionals to falls. This lack of~     awareness of the risks faced by the associated geriatric population falls generates~     reluctance to adherence to a fall prevention program . At European level there are the same~     gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .~      HYPOTHESIS: The implementation of a multicomponent fall prevention program in frail and~     pre-frail elderly community-dwelling people reduce the incidence of falls.~      OBJECTIVES~      General:~      • To determine the efficacy of a comprehensive program to prevent falls in the community.~      Specific:~        -  Knowing whether reducing the incidence of falls implies a reduction in visits to~          primary care, emergency department or hospital staying.~        -  Knowing the adhesion, through indirect measures, to the intervention program.~        -  Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and~          clinical profile, including falls, of the sample.~      MATERIAL AND METHODS~      Study design:~      Multicenter community intervention study, longitudinal, prospective, randomized, and~     experimental.~      Through intervention by nurses in primary care education of subjects over 70 years it is to~     know the effectiveness of a comprehensive program of falls prevention.~      It will proceed to recruit older than or equal to 70 years subjects, who meet frailty~     criteria age, belonging to the areas of Madeira Island (Portugal) and La Ribera County~     (Valéncia, Spain) .~   "
32565|NCT02630797|"~     This study uses a bone labeled calcium tracer methodology to compare the dose response~     effect of blueberry consumption on calcium retention and bone loss. Post menopausal women~     will receive food or beverage products containing freeze dried blueberries over a 50 day~     period equivalent to low (0.75 cups), medium (1.5 cups), and high (3 cups) of fresh berries.~     The hypothesis is that the polyphenolic content of higher doses of blueberries will reduce~     calcium loss from bones.~   "
32791|NCT02627846|"~     A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation~     (ClariVein®) in the management of superficial venous insufficiency.~   "
32526|NCT02631317|"~     PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on~     hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS).~     With a proposed Reengineered Process Framework for intravenous thrombolysis process by the~     PROMISE study steering committee, about 30 medical centers enters would be recruited~     nationwide, and each center would include consecutive AIS patients with an onset-to-door~     time (ODT) of less than 3.5 h. The investigators hypothesize that the proposed Reengineered~     Process Framework is suitable and feasible for hospitals in mainland of China; the rate of~     intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h~     would be more than 20% or be increased by 40% as compared with baseline; the proportion of~     patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be~     with an increase by ≥ 40% as compared with baseline.~   "
32527|NCT02631304|"~     The purpose of this study is to assess the association between the point-of-care (POC)~     measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and~     postoperative delirium in elderly patients undergoing cardiac surgery.~      Furthermore the investigators aim to identify factors, which influence the baseline levels~     and the time course of ChE activity.~   "
32528|NCT02631291|"~     This study is for adults 60 years and older who are grieving the recent loss of a spouse or~     partner. Bereavement is one of the most distressing transitions faced by older adults and~     triggers dramatic changes to older adults' daily routine which puts them at-risk for a mood~     disorder. The purpose of this study is to promote bereaved elders' mental health by focusing~     on healthy lifestyle practices. Study treatment involves using a tablet to record their~     daily physical activity, diet, and sleep behaviors, for 12 weeks. The investigators~     follow-up with people for up to one year.~   "
32529|NCT02631278|"~     The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF)~     system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine~     fibroids.~   "
32530|NCT02631265|"~     It has been reported that insulin basal rate reduction initiated at exercise onset can~     reduce the hypoglycemic risk during exercise. However, another potentially more efficient~     strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a~     certain time prior to exercise. No study investigated what would be the best timing to~     initiate such temporary basal insulin reduction. Therefore, the objective of this study will~     be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia~     during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate~     at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3)~     reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the~     time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes~     prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are:~     1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes~     prior to exercise compared to a reduction at the time of exercise; 2) Time spent in~     hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to~     exercise compared to a reduction 20 minutes prior to exercise.~   "
32531|NCT02631252|"~     This is an open label phase I clinical trial of hydroxychloroquine (HCQ) ,when it is~     combined with the usual medications for acute myeloid leukemia, mitoxantrone and etoposide.~     The purpose of this study is to find the safest and most effective dose of~     hydroxychloroquine with these medications. The investigators will be testing to see if it~     can increase the effectiveness of mitoxantrone and etoposide.~   "
32532|NCT02631239|"~     Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and~     heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%.~     The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western~     countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for~     these patients. But the optimal treatment schedule is controversial. The previous protocols~     usually contained high dose methotrexate, but the application of them is limited for the~     toxicity.~   "
32533|NCT02631226|"~     The purpose of this study is to determine the prevalence and risk factors for~     multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women~     admitted to the hospital and its transmission to the newborn, in order to avoid neonatal~     intensive care unit spread and nosocomial outbreaks.~   "
32534|NCT02631200|"~     This study will test the feasibility of carrying out a randomised controlled trial,~     incorporating a mixed methods process evaluation, to evaluate advance care planning with~     older patients who have end-stage kidney disease.~   "
32535|NCT02631187|"~     This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK)~     multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3)~     retraction pockets (RPs). This future study will aim to address the question: Does BET~     improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in~     adult patients?~      Currently conservative treatments for this condition has been shown to be ineffective; there~     is a significant risk of progression to hearing loss or more serious complications in~     untreated retraction pockets; and the surgical treatments available to us in the UK not only~     have a number of risks and drawbacks, but also do not aim to treat the underlying cause~     (Eustachian Tube dysfunction (ETD)).~   "
32536|NCT02631174|"~     The potential role of ATIII in achieving and maintaining adequate anticoagulation in~     pediatric patients on the heart-lung machine has recently taken on increased importance as~     caregivers strive to mitigate the risk for clinically significant clotting problems. It is~     known that ATIII levels are decreased in normal neonates and infants less than 6 months of~     age relative to older children and adults and become even further decreased in critically~     ill neonates and infants, including those with congenital heart disease. The current~     utilization of ATIII in the context of support on a heart-lung machine is based on~     pharmacokinetic data derived from adult subjects with congenital ATIII deficiency. There is~     a gap in knowledge as to the appropriate frequency of ATIII repletion, best method of~     monitoring, and mode of administration in critically ill neonates and infants receiving~     support on a heart-lung machine.Our long-term goal is to determine if antithrombin (ATIII)~     can effectively change the coagulation system in patients undergoing heart-lung machine~     support. The objective of this proposal, which is our first step in pursuit of that goal, is~     to determine the pharmacokinetics of ATIII in neonates and infants. Our central hypothesis~     is that ATIII will have different pharmacokinetic properties in neonates and infants than~     adults and these properties will be affected by the use of heart-lung machine.~      This research will result in critical data on the pharmacokinetics of ATIII in neonates and~     infants receiving heart-lung machine support. This contribution is significant because it is~     the first step in a continuum of research that is expected to lead to the development of a~     therapeutic strategy employing ATIII that will facilitate improved modulation of the~     coagulation cascade to prevent significant clotting and bleeding complications in pediatric~     patients requiring heart-lung machine support.~   "
32538|NCT02631148|"~     In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to~     extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly~     controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether~     sleep extension and nightly melatonin supplementation in the community is a feasible~     intervention with a beneficial effect on the following chronic kidney disease (CKD) risk~     factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation~     (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone~     excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured~     by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave~     analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance~     and β-cell response to a mixed meal protocol.~   "
32539|NCT02631135|"~     It is important to wake up without any problem and comfortably from the general anesthesia.~     The aim of this study is to investigate the effects of addition dexmedetomidine to the~     balanced intravenous anesthesia with propofol over the cognitive functions and also it is~     considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in~     TİVA. Together with this effects, it has been considered that the disorder of the cognitive~     functions in postoperative period and the need for anesthetic drugs in postoperative period~     will be less.~      After the approval of the Ethics Committee and the patients being informed and taking~     informed consent from them 15 male 25 female totally 40 patients between the age of 20-60~     years old, who had lumbar disc hernia, under general anesthesia have been taken under the~     study. The patients have been divided into two groups by closed envelope drawing method,~     randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State~     Examination) during the premedication visit. For this study group Standardized Mini Mental~     Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained~     patients, and test composed of question-answer in order to calculate the remembering,~     caution and calculation structure and the scores were recorded. All patients had received~     the same anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the~     30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were~     arranged between 40-60 until the end of the operation), and remifentanil infusion (0.5~     μg.kg-1 was applied as opioid and was arranged according to the tension artery and heart~     rate). In the dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1~     without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1~     iv. was applied for the endotracheal intubation. After the operation all patients have taken~     to the recovery room.~      Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24~     hours, 1 week and 1 month.~   "
32540|NCT02631122|"~     The aim of this study is to evaluate differences between ultrasound guided supraclavicular~     versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block~     techniques that differ in their needle trajectory and injection site.~   "
32541|NCT02631109|"~     This study aimed to investigate the efficacy and safety of Pegaspargase together with~     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage~     therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.~   "
32542|NCT02631096|"~     The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the~     safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of~     intravenous ARB-001467~   "
32543|NCT02631083|"~     The study is carried out to find out the inclusion of high and low glycaemic index foods to~     daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.~   "
32544|NCT02631070|"~     The study will be conducted in compliance with the International Council on Harmonisation~     (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good~     Clinical Practice (GCP) and applicable regulatory requirements.~      This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to~     determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with~     anemia due to International Prognostic Scoring System-Revised (IPSS-R) very low, low, or~     intermediate Myelodysplastic syndrome (MDS) with ring sideroblasts (≥ 15%) who require Red~     blood cell (RBC) transfusions.~   "
32545|NCT02631057|"~     The primary objective of this study is to compare the LoS from treatment of oral~     anticoagulant initiation to hospital discharge of patients hospitalized and subsequently~     treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world~     Japanese clinical practice. The secondary objective of the study is to compare LoS of~     patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial~     fibrillation. Other objectives are (1) to compare the in-hospital direct and~     indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of~     patients directly discharged at home after the index hospitalization between dabigatran and~     warfarin.~   "
32546|NCT02631044|"~     This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of~     modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell~     NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety~     and antitumor activity. We will also determine how long the modified T cells stay in the~     patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma~     whose disease has come back or has not responded to treatment.~   "
32547|NCT02631031|"~     The choice of drug administration time may affect the pharmacokinetics and/or drug response,~     and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects~     or to enhance efficacy. This study designed to investigate the potential influence of the~     time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in~     healthy subjects.~   "
32548|NCT02631018|"~     The purpose of this study is to compare the effect of a physical activity-enhanced~     behavioral weight loss intervention, compared to a standard behavioral weight loss~     intervention in African American women.~   "
32549|NCT02631005|"~     The purpose of this study is to evaluate the effects of Walk With Ease, a~     moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus.~     Participants will receive a copy of the Walk With Ease workbook. The book provides~     guidance about walking safety as well as how to start, build-up, and maintain a walking~     program. Participants will complete questionnaires assessing their symptoms before and after~     completing the six-week program.~   "
32550|NCT02630992|"~     To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced~     concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered~     at 90/3.2 mg/kg/day in two divided doses for 10 days. Investigators will focus on the~     proportion of subjects who develop protocol-defined diarrhea and proportion who develop~     diaper dermatitis that occasions the prescription of antifungal medication.~   "
32551|NCT02630979|"~     The study measures the degree of oncology physician satisfaction with the outcomes of some~     cytotoxic agents.~   "
32553|NCT02630953|"~     The overall goals of this renewal are to replicate the findings of Seamos Saludables in~     Latina women, increase the effectiveness of the intervention, and measure~     intervention-related changes in clinical biomarkers. We will enhance the existing~     intervention by incorporating participant feedback (desire for greater interactivity and~     accountability), further targeting Social Cognitive Theory (SCT) constructs that were not~     influenced overall by the original intervention yet improved amongst our most successful~     participants (social support, outcome expectancies), and responding to changing trends and~     technology use in Latinos. We will conduct a clinical trial among Latina women in California~     randomized to either 1) the original Seamos Saludables tailored print only intervention or~     2) a theory and text messaging-enhanced interactive technology based version of the Seamos~     Saludables intervention. We will also measure changes in cardiovascular and metabolic~     biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.~   "
32554|NCT02630940|"~     Analysis of exhaled breath condensate biomarkers and cough severity in patients with~     idiopathic pulmonary fibrosis.~   "
32555|NCT02630927|"~     The purpose of the study is to investigate a drug called AG-519, which is being developed~     for the treatment of a disease called pyruvate kinase deficiency (also known as PK~     deficiency) and other forms of anemia. This study is a 5 part study with Part 1 enrolling~     healthy volunteers into single ascending dose (SAD) groups, Part 2 enrolling healthy~     volunteers into multiple ascending dose (MAD) groups and Part 3 enrolling healthy volunteers~     to investigate how much of the study drug is taken up by the body and how food affects the~     uptake of a prototype formulation of AG-519, Part 4 enrolling healthy volunteers of Japanese~     origin to compare to the results of subjects of non-Japanese origin, and Part 5 a~     non-randomized, open-label, multiple dose study enrolling healthy volunteers to further~     investigate how much of the study drug is taken up by the body when dosed over 14 days.~   "
32556|NCT02630914|"~     The objective of the study is to investigate the feasibility of a hybrid procedure removal~     of the atrial fibrillation.~      This is a single procedure for both surgical epicardial by minimally invasive route~     (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal~     intracavitary route at the same time.~      This faster procedure combined with complete lesions have a higher success rate and less~     frequent re-hospitalizations of patients.~   "
32557|NCT02630901|"~     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics~     and immunogenicity of PRX003 in approximately 56 patients with Psoriasis.~   "
32558|NCT02630888|"~     The main goal of this study is evaluate the efficacy of memantine association on the~     treatment with a previous combination of two drugs, including quetiapine with lithium or~     quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders~     or partial responders to that combination of drugs and evaluate the impact of this~     association at the cognitive functioning of the patients.~   "
32559|NCT02630875|"~     This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients~     with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus~   "
32560|NCT02630862|"~     The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy~     for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.~      Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including~     vasodilation and antioxidant properties.~      A role for oxidative stress has been suggested in acute cerebrovascular disease. In this~     study the investigators want to test the in vivo antioxidant activity of dipyridamole in~     patients who are candidate to take the drug under approved conditions of the Italian Drug~     Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis~     (>= 70%).~      To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products~     of cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months~     therapy after carotid endoarterectomy. Since dipyridamole is approved as combination~     preparation with aspirin, a control group of patients taking aspirin alone is enrolled.~      Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points:~     baseline and 6-months therapy.~   "
32561|NCT02630849|"~     Chronic post-thoracotomy pain is a significant adverse outcome of thoracic surgery.~     transcollation technology evaluated with a prospective randomized trial the effect of a~     multimodal no-compression suture technique of the intercostal space on postoperative pain~     occurrence in patients undergoing mini-thoracotomy.~      Patients undergoing a muscle-sparing lateral mini-thoracotomy for different thoracic~     diseases were randomly divided into two groups:one group received intercostal muscle flap~     harvesting and pericostal no-compression edge suture (IMF group), and the second group~     received a standard suture technique associated with an intrapleural intercostal nerve block~     (IINB group).~      The aim of the study was to demonstrate that the multimodal no-compression suture technique~     is a rapid and feasible procedure reducing early and chronic post‐thoracotomy pain~     intensity.~   "
32562|NCT02630836|"~     Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot~     study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the~     two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month~     with the primary objective of safety. Secondary objectives are efficacy through axial~     tomography and xRay, clinical efficacy and quality of life questionnaire.~   "
32563|NCT02630823|"~     Due to the high expression of PD-L1 in endometrial cancers as well as in ovarian cancers~     which are molecularly similar to uterine serous cancers, using pembrolizumab should be~     beneficial in this patient population. Since the investigators are able to get a~     pre-treatment research- related endometrial biopsy as well as the surgical specimen post two~     cycles of pembrolizumab, the investigators will be able to evaluate the mechanism of action~     of this drug on the endometrial cancer tumor environment.~   "
32564|NCT02630810|"~     This study evaluates the effect of early oral hydration on bowel movement after CS, it~     includes 2 groups: study group participants receive 100 ml water after 1hr from the end of~     CS, while the others receive water after 6hrs from the end of CS.~   "
32792|NCT02627833|"~     Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process~     leads to obliteration of the small airways. Pulmonary function tests (body plethysmography~     with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is~     measured. A blood test is following to determine the inflammatory status und collect miRNA.~     Induced Sputum will be obtained.~   "
32566|NCT02630784|"~     VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two~     mechanical ventilators during non-invasive ventilation for patient suffering from~     respiratory acidosis.~      This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV)~     functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a~     dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an~     exhalation valve.~      Patient will be randomized before the first NIV session lasting 2 hours. After a two hours~     wash-out, a second NIV treatment will be delivered with the other ventilator for duration of~     2 hours.~      Arterial blood samples will be collected at the beginning and the end of each session of~     NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient~     monitoring.~   "
32567|NCT02630771|"~     This proposal will investigate pain modulatory mechanisms and brain functional and~     structural characteristics using multiple MRI modalities in persistent dentoalveolar pain~     disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures~     from patients will be compared to painfree controls.~   "
32568|NCT02630758|"~     The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga~     intervention on depressive symptoms and rumination among depressed women.~   "
32569|NCT02630745|"~     The aim of the study is to conduct a prospective randomized clinical trial to evaluate the~     effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic~     treatment on periodontal healing of the concurrent endodontic -periodontal lesion with~     communication.~   "
32570|NCT02630732|"~     The primary scientific objective of the study entails examining whether perioperative pain~     neuroscience education (PPNE or 'brain school') is more effective than classical back school~     in reducing pain and improving pain inhibition in patients undergoing surgery for spinal~     radiculopathy. A secondary objective implies examining whether PPNE is more effective than~     classical back school in imparting a behavioural change (i.e. decreasing postoperative~     healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and~     improving surgical experience (=better prepared for surgery, surgery meeting their~     expectations) in patients undergoing surgery for spinal radiculopathy.~   "
32571|NCT02630719|"~     The goal of this study is to determine whether timolol eye drops are effective in~     alleviating acute migraine headaches. Subjects will be randomized to receive either timolol~     eye drops or placebo (tears) to use as a migraine abortive medication.~   "
32572|NCT02630706|"~     This is a study is to evaluate the efficacy and safety of the addition of ertugliflozin to~     metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have~     inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the~     mean reduction from baseline in hemoglobin A1C (HbA1C) for both 15 mg and 5 mg ertugliflozin~     is greater than for placebo.~   "
32573|NCT02630693|"~     The purpose of this study is to determine if the combination of endocrine therapy and~     Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer~     dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28~     day cycle in combination with endocrine therapy.~   "
32574|NCT02630680|"~     The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life~     setting in a representative sample of the European target population.~   "
32575|NCT02630667|"~     The aim of this study is to investigate the acute effects of ingestion of carbohydrates -~     with different glycemic profiles - on cognitive function among preadolescent children (i.e.,~     9-10 years).~   "
32576|NCT02630654|"~     This exploratory study aims to evaluate the diagnostic, prognostic and response predictive~     value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine~     Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed~     methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an~     interesting approach to solve this question (Lundberg et al 2011).~   "
32577|NCT02630641|"~     The general hypothesis put forward in this study is that the degree of cohesion (agreement)~     in the relationship, or dyadic adjustment affects a patient's quality of life and clinical~     course during the first few critical months following diagnosis and the introduction of~     treatment. The level of cohesion in the relationship is certainly not the only parameter~     associated with changes in the quality of life. Other factors must also be investigated such~     as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse),~     management (single therapy or adjuvant therapy), the level of physical activity, the~     patient's age and the presence of functional disorders, etc.~   "
32578|NCT02630628|"~     Prospective, randomized, parallel-group controlled, open-label, international (Asian)~     multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined~     with MMF.~   "
32579|NCT02630615|"~     The primary objective of this study is to establish circulating tumor cell (CTC) derived~     xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA~     repair mutations detected in CTC samples (personalize DNA repair therapy).~   "
32580|NCT02630602|"~     The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on~     obese and overweight people with altered lipid profile. The functional goat cheese~     containing polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to~     benefit cardiovascular health of people who need to normalize lipid profile; which in the~     long term can contribute to the prevention of cardiovascular diseases.~   "
32588|NCT02630498|"~     This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder~     surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The~     first group will include those who receive a single shot brachial plexus (interscalene,~     supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The~     second group will be the control group and include those patients who receive general~     anesthesia only, without any block whether due to the preference of patient or the surgeon~   "
32589|NCT02630485|"~     The purpose of this study is to help women with PCOS to improve their symptoms and ovulation~     rate through a lifestyle intervention program which introduces a specific diet, a physical~     activity regimen and mindfulness exercises to improve psychological well-being and overall~     health.~   "
32841|NCT02627196|"~     The Barostim Neo - Baroreflex Activation Therapy for Heart Failure is a prospective,~     randomized trial in subjects with reduced ejection fraction heart failure.~   "
32581|NCT02630589|"~     Tinnitus is the perception of sound or noise in the absence of an external physical source.~     It is a highly prevalent condition and for a high percentage of patients, there is no~     satisfying treatment modality. For some people, tinnitus has a very severe impact on quality~     of life, leading to incapacity for work and sometimes even suicidality. The auditory~     brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients~     with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by~     tumor growth in neurofibromatosis type II. It has been shown that the standard intended~     effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the~     cases. This is in analogy with the promising effect of a cochlear implant (CI) as a~     treatment for patients with unilateral tinnitus. In this study, the effect of an ABI on~     severely invalidating, unilateral, intractable tinnitus will be investigated. The ABI may~     have an advantage over the CI as tinnitus treatment, because CI-implantation leads to~     destruction of inner ear structures, leading to profound deafness, while an ABI is presumed~     to not damage anatomical structures. This is the first study to implant an ABI for the~     primary aim of tinnitus reduction in an intervention pilot study. In total 10 patients with~     unilateral, intractable tinnitus and severe hearing loss in the ipsilateral ear, will be~     implanted with the ABI.~   "
32582|NCT02630576|"~     TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered~     neuromuscular monitoring system intended for daily clinical use. The primary aim of this~     clinical investigation is to examine the applicability (ease of use, equipment need, etc.),~     repeatability (precision or internal consistency) and performance (signal quality, accuracy~     of outcome, voltage of stimulation output before and during a stimulus) and tolerability of~     the Tetragraph device in healthy volunteers.~   "
32583|NCT02630563|"~     The study is planned to be conducted in 2 parts. The first part (open label, multi-center,~     non-controlled) of the study will estimate a dose that would provide a mycophenolic acid~     (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver~     transplant participants receiving the approved dose of mycophenolate mofetil (MMF,~     CellCept). The second part (open-label, multi-center, single-arm Phase IV study) of the~     study will provide the pharmacokinetics, efficacy and safety profile of the proposed dose in~     the immediate post-transplant period. This study will be conducted at two centers based in~     the United States of America. Twelve pediatric transplant participants receiving a first~     liver allograft from a cadaveric or living donor will be enrolled in this study. Stable~     pediatric liver transplant participants who are at least 6 months post-transplant and who~     were already receiving stable dose of MMF in combination with cyclosporine will be enrolled~     into the study. Participants should have received stable MMF dose according to center~     practice for at least seven days in order to get steady state pharmacokinetics (PK).~     Participants also should have received stable concomitant doses of cyclosporine (for at~     least 2 days) and corticosteroids per center practice. Participants will be aged between 9~     months and 12 years, with at least 6 participants greater than or equal to (>/=) 9 months~     and less than (<) 36 months, of whom at least 2 will be <24 months.~   "
32584|NCT02630550|"~     The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in~     various clinical contexts but not during the occlusion of major arteries, as takes place in~     vascular surgery. The present study will evaluate the precision and validity of the measures~     taken by the device during open vascular surgery procedures. The measurements will be~     compared to the those calculated by transesophageal echocardiography at various key points~     during the surgeries. The validity of the cardiac output, stroke volume and stroke volume~     variation measurements will be evaluated, as well as the device's ability to track rapid~     changes in cardiac output.~   "
32585|NCT02630537|"~     Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection~     of transplanted organs. Thus, in transplant recipients a life-long and individualized~     immunosuppressive medication is required to avoid graft rejection. However, a too weak~     suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas~     a too potent suppression of CMI supports opportunistic infections and reactivation of~     persistent viruses.~      One of the biggest challenges in the field of transplantation is to provide a personalized~     immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI.~     This could lead to a reduction of graft rejections and virus reactivations in transplant~     recipients.~      With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH~     has implemented its novel proprietary T-activation technology for an improved assessment of~     the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus~     (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays~     open up the opportunity to characterize the functionality of CMI as an entire network.~      The planned clinical multicenter study aims to verify the suitability of the two assays for~     a reliable assessment of the functionality of CMI.~      Hemodialysis patients have been identified as an appropriate patient cohort for~     investigating the clinical sensitivity of the Lophius assays as these patients closely~     resemble kidney transplant recipients prior to an immunosuppressive therapy.~      The determination of the functional CMI in the course of an immunosuppressive treatment may~     in future enable physicians to optimize the individual immunosuppressive and antiviral~     therapy in transplant recipients to reduce the risk of rejection as well as virus~     reactivations and associated diseases.~   "
32586|NCT02630524|"~     The purpose of this study is to examine the effectiveness of a low carbohydrate diet on~     increasing dietary adherence and improving cardiometabolic risk factors among adults with~     spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one~     of two groups: 1) a reduced carbohydrate diet or 2): a standard diet (STD). Participants~     will take part in a 6-month behavioral lifestyle intervention implemented through a novel~     eHealth platform specially designed for individuals with SCI.~   "
32587|NCT02630511|"~     Although asthma is a disease of the airways, research is now showing that asthmatics are~     more likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular~     dysfunction is seen in people at high risk of CVD and has been linked to inflammation.~     During an asthma attack, levels of inflammation in the whole body increase, which could~     potentially explain why asthmatics are at increased risk of CVD. By exercising, people can~     change the amount of inflammation in their bodies, improve vascular function, and thereby~     reduce the risk of CVD. In the proposed study the investigators will assess if asthma~     attacks lead to increased risk of CVD by evaluating inflammatory levels and vascular~     function before and after asthma attacks. The investigators will also evaluate if exercise~     reduces the cardiovascular risk following asthma attacks. The results from this study will~     help in understanding why asthmatics are at increased risk of CVD.~   "
32974|NCT02625454|"~     The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in~     laboring patients by either an oral or intravenous (IV) route. The investigators want to see~     if the maternal fever will decrease faster with the IV or the oral dose. The investigators~     also want to look at other outcomes such as the cesarean section rate, the rate of neonatal~     intensive care unit admissions in both groups.~   "
32590|NCT02630472|"~     The purpose of the study is to evaluate the physiologic response of quinine-saline~     irrigations for acute exacerbation of uncomplicated chronic rhinosinusitis following~     endoscopic sinus surgery. Subjects who have previously had functional endoscopic sinus~     surgery with acute exacerbation of chronic rhinosinusitis will be randomized to either a~     quinine-saline or saline-placebo arm. The investigators will measure baseline and follow-up~     clinical and quality-of-life outcomes for both arms, and then compare the groups at the end~     of the study period. The investigators' hypothesis is that the participants in the quinine~     sulfate arm will perform better on all measures as compared to the control arm.~   "
32591|NCT02630459|"~     Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by~     an open-label treatment phase. To evaluate the effect of AMG 334 compared to placebo on the~     change from baseline in monthly migraine days.~   "
32592|NCT02630446|"~     The general objective of this quasi-experimental study is to assess the effectiveness of an~     in-home respite care program compared to a control group not receiving the same type of~     in-home respite on the well-being of the caregiver, the care-recipient and on the healthcare~     system. The latter in terms of resource use, intention to institutionalize the~     care-recipient and time to nursing home placement.~      A quasi-experimental study will be designed. The intervention group will consist of~     caregiver/care-recipient dyads receiving an in-home respite program called Baluchonnage~     and will be compared to a control group that doesn't receive Baluchonnage. Comparison~     between the groups will be done by collecting health related and economic data. The trial~     will evaluate outcomes as well in the caregiver as in the care recipient (measured via the~     caregiver). The primary research outcome is caregiver burden. Secondary outcomes for~     caregivers are: health related quality of life and reactions to behavioral problems of the~     care-recipient. A secondary outcome related to the care-recipient is: frequency of~     behavioral problems. Secondary outcomes for the healthcare system are: intention to~     institutionalize the recipient into a nursing home and resource use of the recipient.~     Finally, in a follow up phase of the trial possible differences in time to nursing home~     placement will be measured (as well as burden and intention to institutionalize.~     Additionally, willingness to pay for Baluchonnage per day will be asked to the informal~     caregivers. Eventually, if the intervention is effective, modeled and trial based~     cost-effectiveness analyses will be undertaken in a separate economic evaluation plan.~   "
32593|NCT02630433|"~     There are controversies optimal timing for cholecystectomy in patients with mild biliary~     pancreatitis. The safety of cholecystectomy performed during an episode of pancreatitis has~     been questioned. The aim of the present randomized controlled trial is to compare the~     outcome in terms of recurrent pancreatitis and gallstone-related events between index~     cholecystectomy, performed during the first admission for acute pancreatitis, and scheduled~     cholecystectomy, performed 4-6 weeks after discharge.~   "
32594|NCT02630420|"~     Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras~     wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this~     drug combination and will include patients with squamous cell carcinoma of the head and neck~     cancer, as well as patients with CRC. Part 2 of the study, the focus of this registration,~     will obtain further safety data for the combination of cextuximab and savolitinib and will~     look at the efficacy of cextuximab and savolitinib in Ras wild-type mCRC that was previously~     treated and relapsed on cetuximab or panitumumab.Correlative studies will examine tumor and~     blood specimens for mechanisms of anti-EGFR resistance and response to MET inhibition.~   "
32595|NCT02630407|"~     The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the~     post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers~     and promoting a faster recovery after ACL reconstruction, seems attractive.~      The aim of the present double blind, placebo controlled study is to evaluate the effects,~     both in terms of pain control and functional recovery, provided by a single HA injection~     performed in the early postoperative phase after ACL reconstruction.~      The day after the ACL reconstruction (which is performed with the same technique for all the~     patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml~     of saline solution. The randomization list was kept in a dedicated office and the injecting~     physician contacted it to know the treatment allocation just before the injection, that was~     performed by a lateral parapatellar approach, after removing the drainages and after~     attempting aspiration to evacuate any eventual residual blood from the joint. In order to~     maintain the patient blind to the treatment, a surgical drape was placed to prevent him to~     see the injective procedure.~      All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the~     following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and~     Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees~     were registered at each follow-up evaluation.~   "
32596|NCT02630394|"~     Acute chest syndrome (ACS), a lung complication in sickle cell disease (SCD), is the second~     most common cause of hospitalization and leading cause of death in SCD. ACS is associated~     with airway inflammation, and a major cause is pulmonary infection from atypical organisms.~     To date, there are no drugs available to reduce inflammation and risk of recurrent ACS.~     Macrolides are a group of antibiotics that exert immunomodulatory and anti-inflammatory~     actions both in vitro and in vivo. In addition, macrolides reduce bacterial burden in the~     airway of atypical organisms, all of which play an important role in the pathophysiology of~     ACS. Numerous studies have evaluated macrolide prophylaxis in conditions associated with~     lung inflammation, such as cystic fibrosis, asthma, bronchiectasis etc., and high quality~     evidence have found macrolides to be beneficial as a disease modifying agent that leads to~     improvement in airway inflammation, reduced pulmonary exacerbations and improved lung~     function. The investigators hypothesize that azithromycin prophylaxis is well tolerated and~     has the potential to reduce inflammation and improve lung outcome in children with SCD with~     a history of ACS. A prospective, single arm, open label feasibility study of azithromycin~     prophylaxis will be performed in children with SCD with a history ACS with the specific aim~     to examine the feasibility, safety and tolerability of azithromycin prophylaxis~     administration in participants with SCD , and to examine whether azithromycin prophylaxis~     has the potential to improve lung outcome. In addition, this study will determine whether~     azithromycin prophylaxis reduces inflammation in participants with SCD with a history of~     ACS.~   "
32597|NCT02630381|"~     Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is~     why prevention of these fractures is important. The investigators have shown in animal~     studies that a single treatment with unfocused extracorporeal shock wave therapy leads to~     highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal~     shock wave therapy could have important implications for the prevention of osteoporotic~     fractures.~      Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.~      Study design: A clinical pilot study. Study population: Twelve female patients are eligible~     if they are undergoing elective surgery of the lower extremity or elective spinal surgery~     under general anesthesia in the investigators hospital.~      Intervention: When the patient is under general anaesthesia he/she will receive 3000~     unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm.~     The contra lateral forearm will not be treated and serves as a control.~      Main study parameters/endpoints:~      The investigators will examine the effect on bone mass with the use of repeated dual energy~     X-ray absorptiometry measurements. These results are necessary to calculate the number of~     patients that are needed for larger studies. Furthermore, the investigators will assess~     patient's discomfort.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: General anaesthesia is performed during treatment and pain after the procedure~     will be evaluated using pain scales and, if necessary pain medication will be prescribed by~     the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause~     very low radiation exposure to the patient.~   "
32598|NCT02630368|"~     Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients~     with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated~     Dose have been determined (phase I trial).~      Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating~     study design assessing two dose levels of JX594 when prescribed in combination with~     metronomic cyclophosphamide.~      Phase II study sarcoma: this is a monocentric, randomized two-arm non comparative phase 2~     study assessing efficacy and safety of JX-594 in association with metronomic~     cyclophosphamide in patients with advanced soft-tissue sarcoma.~      Phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing~     efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients~     with advanced breast cancer.~   "
32599|NCT02630355|"~     This study evaluates the use of remote ischaemic preconditioning for the prevention of~     dialysis induced cardiac injury. The study uses four arms to test different frequencies of~     application to ascertain which, if any, is most successful at reducing dialysis induced~     cardiac injury.~   "
32600|NCT02630342|"~     Diagnostic Magnetic Resonance (MR) imaging procedures can be stressful for children and~     parents. Patients must lie still during the procedure to provide diagnostic quality images.~     Children <7 years are often sedated or given general anesthesia (GA) for imaging procedures.~     The high cost of GA and its associated risks motivate the search for alternatives. The~     overall goal of this study is to systematically investigate whether training on the mock MR~     scanner reduces the need for GA during Magnetic Resonance Imaging (MRI) scans in children.~      160 participants scheduled for diagnostic MRI scans at Alberta Children's Hospital (ACH)~     will be recruited to undergo different training methods for MRI scanning. Group 1 will be~     sent links to online videos about MRI, audio files with scanner noises, and a children's~     book about MR scans, to prepare at home. Group 2 will receive training materials and visit~     the ACH to review them with the research team, but will not use the mock scanner. Group 3~     will receive training materials and visit the ACH for training on the mock MR scanner.~     Visits to the mock scanner for Group 3 will include practice lying down, staying still,~     wearing headphones, and watching a movie on the mirror system. During and after training~     sessions, the investigators will collect data on total time spent preparing (mock scanner or~     other), the child's feelings of stress/worry before and after visit, and head motion during~     mock MRI session (if applicable).~      Subjects will be scheduled for a clinical scan without GA and a follow-up clinical scan with~     GA (to be cancelled if the first scan is successful). Scan success will be determined by a~     radiologist. Measures of scan success, quality ratings for each scan, children's feelings of~     stress/worry related to the MRI, and saliva samples to measure cortisol and salivary alpha~     amylase, will be gathered at the clinical scan. An ANOVA will be used to compare different~     training groups.~      A clinical group of 35 neuro-oncology patients aged 3-7 years of age that undergo frequent~     MRI scans will also undergo staged preparation by child life specialists using the mock~     scanner. The age at which they are able to complete MRI without general anesthesia will be~     compared with a retrospective control group in the 3 years prior. Measures to be used for~     this group are the same (with the exception of saliva samples). T test and Kaplan- Meier~     analysis will be used to compare age at which MRI can be performed awake.~   "
32601|NCT02630329|"~     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and~     established laparoscopic removal of benign adnexal masses Study design: Randomized~     controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.~      Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal~     masses detected by clinical examination and ultrasound.~      Randomization: Women will be randomly allocated to undergo one of two techniques for removal~     of the benign adnexal mass immediately before surgery by using a computer generated~     randomization list. The investigators will use stratified randomization according to the~     cyst diameter.~      Intervention: Women will be treated by a surgeon who is not blinded to the treatment~     allocation and who is equally skilled in performing both techniques. In the intervention~     group a vNOTES technique will be used.~      Control: In the control group surgery will be done by a classical laparoscopic technique.~      Participants, nursing staff and outcome assessors will be blinded.~      Main study parameters/endpoints:~      Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary~     outcomes: the proportion of women discharged the same day based on their own preference;~     postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7~     by the participating women following surgery and the total amount of analgesics used as~     described in the standardized pain treatment protocol between day 1 till 7; postoperative~     infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or~     laboratory findings; per- or postoperative complications according to the Clavien- Dindo~     classification detected during the first six weeks of surgery; duration of the surgical~     procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6~     months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing~     recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale);~     direct costs associated up to 6 weeks after the surgical intervention with both procedures.~   "
32602|NCT02630316|"~     This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded,~     placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in~     subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung~     disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will~     include about 314 patients at approximately 100 clinical trial centers. The treatment phase~     of the study will last approximately 16 weeks. Patients who complete all required~     assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).~   "
32603|NCT02630303|"~     The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up~     to 640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is~     safe in human skin.~   "
32990|NCT02625246|"~     To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells~     (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore~     treatment efficacy~   "
32604|NCT02630290|"~     Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent~     influences on the filed of perineural block. It could shorten the onset time and prolong the~     duration of the nerve block and improved postoperative pain. However,~     Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable~     attention because of potentially grave consequences, including sinus arrest and refractory~     cardiogenic shock. A low dose may help minimize cardiovascular risks associated with~     dexmedetomidine. However, few studies have addressed the clinical effects of low-dose~     dexmedetomidine as an perineural adjuvant. The present study was designed to test the~     hypothesis that low-dose dexmedetomidine added to ropivacaine would safely enhance the~     duration of analgesia without adverse effects when compared with ropivacaine alone.~     Investigators will conduct a single-center, prospective, randomized, triple-blind,~     controlled trial in patients undergoing elective forearm and hand surgery under~     ultrasound-guided supraclavicular brachial plexus block using either ropivacaine or~     ropivacaine plus low-dose dexmedetomidine. The primary outcome is self-reported duration of~     analgesia . Secondary outcomes include onset time and duration of motor and sensory block,~     total postoperative analgesics, and safety assessment (adverse effects and postoperative~     abnormal sensation).~   "
32605|NCT02630277|"~     To assess the safety and efficacy of intravitreal aflibercept injection in the regression of~     retinal neovascularization secondary to high-risk PDR.~      To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in~     patients with high-risk PDR~   "
32606|NCT02630264|"~     Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug.~     E10A contains a recombinant human endostatin gene with the second-generation recombinant~     adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin,~     which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks~     tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of~     tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities~     of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been~     demonstrated in Phase I and Phase II studies.~   "
32607|NCT02630251|"~     The study drug, GSK2820151, is a Bromodomain (BRD) and Extra-Terminal (BET) inhibitor~     arising from a distinct structural class. GSK2820151 potently inhibits tumor growth in vitro~     and in vivo in animal models. This first time in human (FTIH), open-label, dose escalation~     study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary~     clinical activity of GSK2820151 in subjects with advanced or recurrent solid tumors. The~     objective is to determine the safety, tolerability and maximum tolerated dose (MTD) of~     GSK2820151 in subjects 18 years or older with advanced or recurrent solid tumors. Eligible~     subjects with advanced or recurrent solid tumors will be enrolled in the dosing cohorts~     until MTD is established. All subjects will receive study drug. Subjects may continue~     treatment in the study until disease progression, unacceptable toxicity, or withdrawal of~     consent. The duration of study will depend on recruitment rates and the timing of subjects'~     duration on study (withdrawal rates due to toxicity or progression). It is anticipated that~     approximately 30 to 50 subjects will be enrolled.~   "
32608|NCT02630238|"~     This double blind placebo study will take place over an 8 week treatment period of diet and~     exercise. All participants (n=16), in two groups, will be placed on the same hypocaloric~     diet and exercise program. Participants will be matched into pairs based on body fat % and~     then assigned into a test group & a placebo group. The placebo will be in the form of a~     powdered isoenergetic beverage with carbohydrate similar in taste & appearance to the powder~     BCAA supplement that the test group will receive. The test group will be put on 0.342g/kg of~     BCAA per day, partially accounted for through their diet with the rest provided by a BCAA~     supplement. At baseline, 4 weeks and 8 weeks habitual 3 day food logs, waist to hip ratio~     and BodPod measures of body fat & lean mass (both percentage & absolute values) will be~     taken for all participants.~   "
32609|NCT02630225|"~     The investigators will conduct a cluster randomized trial of an intervention program that~     combines a hospital-based intervention, structured outreach program, and multi-agency~     attention. The goal of the study is to test the effect of this multi-component intervention~     on subsequent injury, substance abuse, mental health, quality of life, violent behavior,~     criminal activity, and death.~      Investigators aim to enroll a total of 200 patients admitted to the Harborview Medical~     Center (HMC) for firearm-related injuries. Patients will be randomized to receive a~     multi-component intervention or treatment as usual. All participants will complete surveys~     at the time of study consent (baseline) and then at designated time points for 12 months~     post-consent. Study staff will routinely collect participant records from Washington State~     Patrol records, HMC medical records, Washington State trauma registry, Washington State~     Emergency Department Information Exchange, Administrative Office of the Courts, and vital~     records. The investigators will test the impact of the intervention against standard care.~     The primary hypothesis is that participants in the intervention group will see greater~     improvements in aforementioned outcomes than those in the control group.~   "
32610|NCT02630212|"~     The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on~     aortic dissection.~   "
32624|NCT02630030|"~     This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has~     spread or returned after period of improvement who are planning to undergo surgery. When~     given by mouth, ixazomib citrate may be able to reach tumor cells in the brain. Studying~     samples of tissue, blood, and plasma in the laboratory from patients receiving ixazomib~     citrate may help doctors learn more about the effects of ixazomib citrate on the cells. It~     may also help doctors understand how well patients will respond to treatment.~   "
32625|NCT02630017|"~     To investigate the effects of methylphenidate on motivated behavior in adults with and~     without ADHD~   "
32626|NCT02630004|"~     The main purpose of this study is to assess the efficacy of melatonin oral gel compared to~     placebo in the prevention and treatment of oral mucositis in patients with head and neck~     cancer undergoing concurrent chemoradiation.~      Other objectives are to assess the Quality of Life (QoL), to evaluate the safety and~     tolerability and to assess the pharmacokinetic profile of melatonin oral gel administration,~     in all cases compared to placebo in patients with head and neck cancer and oral mucositis~     secondary to concurrent chemoradiation.~   "
32611|NCT02630199|"~     This study is a single center open label phase I study of AZD6738, DNA damage repair/novel~     cancer agent, in combination with paclitaxel in metastatic cancer patients who have failed~     standard chemotherapy.~      AZD6738 is an orally dosed selective and potent inhibitor of Ataxia Telangiectasis and Rad3~     Related (ATR) kinase with good selectivity against other Pi3 kinase family members.~      ATR is a serine/threonine protein kinase and member of the phosphatidylinositol 3-kinase~     related kinase (PIKK) family. During normal replication, ATR is recruited at stalled~     replication forks which can progress to double strand breaks if left unrepaired. ATR is also~     recruited to single strand DNA coated with Replication Protein A (RPA) following single~     strand DNA damage or the resection of double strand breaks. Recruitment and activation of~     ATR leads to cell cycle arrest in the S phase while the DNA is repaired and the stalled~     replication fork resolved, or nuclear fragmentation and entry into programmed cell death~     (apoptosis).~      In the clinic ATR inhibitors are expected to cause growth inhibition in tumour cells~     dependent upon ATR for DNA repair e.g. ATM-deficient tumours. In addition to monotherapy~     activity, ATR inhibitors are also predicted to potentiate the activity of cytotoxic DNA~     damaging agents and radiotherapy (through inhibition of ATR-dependent DNA repair processes)~     when used in combination. While significant enhancement of anti-tumour activity may be~     achieved, data with AZD6738 suggest the potential need to reduce the ATR inhibitor dose and~     intensity (relative to monotherapy dose) and introduce dosing breaks to allow normal tissue~     recovery when used in combination with systemic DNA damaging chemotherapy agents, in order~     to maintain tolerable therapeutic margins.~      The mechanism of action of AZD6738 suggests the potential to combine it with a number of~     anti-cancer treatments, resulting in either synergistic or additive activity. This study is~     evaluating the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD6738 at~     increasing doses, in combination with paclitaxel as one of standard salvage regimen in~     patients with advanced cancer.~      The study will consist of two parts, each evaluating the safety and tolerability of a~     specific combination agent, paclitaxel with different drug schedules. An oral formulation of~     AZD6738 will be used.~      The PART A will be in combination with paclitaxel; the starting dose of 40 mg AZD6738 OD~     will be escalated to reach a maximum tolerated dose in patients with advanced solid~     malignancies, as defined by dose-limiting toxicity. The PART B will be an independent~     parallel PK expansion cohort with cycle 0 of AZD6738 on D1, D8~D21 monotherapy followed by~     combination therapy with weekly paclitaxel from cycle 1. Investigators will modify to~     recruit the minimum or maximum number of patients depending on data generated from other~     studies using AZD6738.~   "
32612|NCT02630186|"~     This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The~     primary purpose of the Phase 1 portion of the study is to observe the safety of the~     combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.~      The primary purpose of the Phase 2 portion of the study is to evaluate the safety and~     anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for~     the combination determined in Phase 1, in patients with EGFR-mutant NSCLC.~   "
32613|NCT02630173|"~     Introduction:~      To evaluate the effect of untreated endodontic infection on periodontal status in untreated~     non vital teeth with periapical radiolucency as compared to contralateral vital teeth. And~     also to evaluate the role of endodontic treatment on periodontal healing in successfully~     endodontically treated teeth with contralateral vital teeth.~      Methods:~      This study was performed in two parts. First part of this study was an observational cross~     sectional survey and second part was a clinical trial on patients selected from the survey.~   "
32614|NCT02630160|"~     A randomized double-blind clinical trial was performed. There were 4 groups according to~     catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2)~     Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial~     catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous~     perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus +~     continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy~     and the surgeon kept out the surgical field when the resident placed the catheter. The same~     conventional analgesic schedule was prescribed to all patients: PCA (patient controlled~     analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of~     PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects,~     time to start rehabilitation and time to discharge were also analyzed. A statistical~     analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).~   "
32615|NCT02630147|"~     The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent~     events in premature infants born between 32.0 and 33.6 weeks of gestational age.~   "
32616|NCT02630134|"~     Study patients are given a hand held device to track pain post surgery.~   "
32617|NCT02630121|"~     The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses~     of intranasal fluticasone propionate will decrease the total number of obstructive apneas~     and hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis~     and mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses~     of NGCS.~   "
32618|NCT02630108|"~     It is a prospective and multi-center clinical research in China to compare the efficacy,~     safety and related impact factors between TACE alone and TACE combined with synchronous~     multi-point MWA/RFA for large and huge liver cancer.~   "
32619|NCT02630095|"~     The purpose of this study is to determine the effect and safety of anticoagulation after~     endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its~     effect on long-term rebleeding rate and mortality.~   "
32620|NCT02630082|"~     Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV~     entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated~     abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at~     high risk of HIV infection. The purpose of this study is to evaluate the feasibility of~     methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection~     in Lima, Peru.~   "
32621|NCT02630069|"~     This study is a 12-week, randomized, double-blind, placebo-controlled trial of~     cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.~   "
32622|NCT02630056|"~     The purpose of this study is to validate the dosimetric parameters that correlate with acute~     hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant~     chemoradiotherapy.~   "
32623|NCT02630043|"~     The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone~     and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is~     approved by the U.S. Food and Drug Administration (FDA) for adults, but is an~     investigational drug in this study because it has not been approved in pediatrics for this~     indication. Oxaliplatin, although a drug approved by the FDA for other cancers, is~     investigational for treatment of neuroblastoma in this study. This study will look at the~     safety and tolerability of tolcapone in combination with oxaliplatin as well as the tumors~     response to this study drug.~   "
32645|NCT02629757|"~     This study is being conducted to help determine whether β-elemene as maintain treatment for~     complete remission patients of newly diagnosed malignant gliomas following standard~     treatment, is able to delay tumor growth, or impact how long people with newly diagnosed~     high-grade glioma.~   "
32627|NCT02629991|"~     The investigators propose a randomized double blind 8 week treatment trial of intranasal OXT~     vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect~     (1) Eating behaviors (2) Repetitive and disruptive behaviors (3) social cognition measures~     and (4) Salivary OXT levels and plasma levels of ghrelin, pancreatic polypeptide and leptin.~     The investigators will determine if IN-OXT reduces eating behaviors in addition to improving~     social cognition and reducing repetitive/disruptive behaviors in children with PWS. If~     superior to placebo, this data will add to the current knowledge that OXT is an effective~     treatment for hyperphagia as well as other problematic symptomatology of PWS.~   "
32628|NCT02629978|"~     The objective of this study is to evaluate the outcomes of radiofrequency ablation in the~     treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable~     candidates for or refuse surgical resection.~   "
32629|NCT02629965|"~     This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over~     trial to assess the effects of once daily administration of orally inhaled tiotropium +~     olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function~     (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities~     after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.~   "
32630|NCT02629952|"~     Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries,~     show great potential as nutraceuticals for the treatment of various diseases such as type 2~     diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood~     lipids, reduce oxidative stress and improve vascular function. For these reasons we recently~     investigated the effects of daily consumption of locally produced blueberry tea and~     demonstrated that this could partially restore insulin sensitivity in an animal model. We~     propose to translate these findings to assess the efficacy of this nutraceutical as a new~     treatment for improving glucose tolerance in people with T2D.~   "
32631|NCT02629939|"~     Cardiac arrest is a public health problem and is the leading cause of death in many parts of~     the world.~      Cardiac arrest can occur inside the hospital and outside it. In the United States and Canada~     occur in approximately 350,000 cases of cardiac arrest a year , who receive CPR , Half of~     them outside the hospital.~      Treatment of cardiac arrest is performing Cardio Pulmonary Resuscitation (CPR) and early~     defibrillation.~      Performing compressions is the essential part of performing CPR until the arrival of~     defibrillation.~      Efforts are being made to simplify the implementation of basic CPR and make it accessible to~     everyone. Method hands only CPR offers CPR with compressions only without ventilations,~     Studies have shown a similar survival rate between hands only CPR method and CPR with~     ventilations.~      Patient's chances of survival are higher if a bystander begins performing CPR until trained~     medical staff arrives.~      Chances of survival decreases by 7-10% every passing minute past moment of collapse if not~     performed CPR.~      MDA survey carried out in 1984-5 reported at the start of CPR by a bystander at 8% Another~     survey in 2000 reported 14%, In a recent study in Jerusalem found a rate of only 15% of~     performing compressions by bystanders- A very low rate compared to 33% reported in the~     United States 41.3% in Japan and 44.9% in Denmark.~      The average time of arrival of the medical team in Israel is 10.3 minutes, so it is very~     important to begin performing CPR by those present before the arrival of medical staff.~      Most cases of cardiac arrest were the result of a previous cardiac disease, Therefore~     patients with cardiac disease are at higher risk of cardiac arrest and cardiac death.~      Place cardiac arrest is 72% percent of the time at home, and the likely presence of family~     members.~      The general population should know basic resuscitation to save a life, knowledge is needed~     especially among families of heart patients who are way more likely that such an event will~     occur in their presence.~      Therefore, one can relate to families of heart patients dedicated to increasing population~     as a basic knowledge of CPR.~      There is no other organized plan to study family members of patients with heart disease~     basic knowledge of CPR Despite the importance of it Attempts have been published in previous~     studies from around the world to create a focus group study of CPR among close relatives of~     heart patients. An attempt was made to incorporate as part of the proposed cardiac~     rehabilitation patients after MI Through self-study kit given at discharge from the hospital~     and more Difficult to evaluate the success of these efforts over the long term, but~     short-term study of short workshops yielded sufficient knowledge about basic CPR This study~     should serve as a catalyst as a first step towards building a suitable program nationwide~     and hopefully save many lives~   "
32632|NCT02629926|"~     Cure rates for childhood malignancies have improved at a remarkable pace.With the increasing~     cure rate came recognition of the long-term detrimental effects of radiotherapy and~     chemotherapy, known as late-effects. Endocrine late-effects are particularly prevalent in~     childhood cancer survivors. Growth Hormone (GH) deficiency is common following radiation to~     the head and leads to impaired growth, hence GH replacement is given to achieve optimise~     final height in childhood. In the adult GH is important to maintenance of bone, muscle & fat~     mass; vascular risk factors; and quality of life. This observational study aims to determine~     the long-term effect of low dose GH replacement on development of bone, muscle and fat mass;~     vascular risk; and quality of life in the early years after achievement of final height, a~     time known as transition. GH is thought to be essential to development of bone, muscle,~     and fat mass during this time period.~      Patients will be identified in the late -effects endocrine clinic, aged 16-22yrs, who are~     severely GH deficient. 30 patients will be recruited to the study who wish to continue~     receiving GH replacement, all of whom will receive recombinant GH. An additional 30 patients~     who do not wish to receive GH replacement will provide a parallel control data.~      All patients will undergo baseline assessment including examination; routine blood tests;~     urine dipstick; measures on height, weight, waist, and 24 hour blood pressure. Measures will~     be repeated at six months, and then annually until 25 years of age. Bone density will be~     measured at baseline, after two years and at age 25yrs. Patients requesting GH replacement~     will require initial additional visits to teach self injection, then 2-4wkly to assess when~     correct dose of GH is achieved. The study will enable assessment of the beneficial effects~     of GH replacement during transition in GH deficient survivors of cancer to be realised.~   "
32633|NCT02629913|"~     The Swiss company mementor has recently developed an interactive self-help intervention for~     the treatment of insomnia entitled mementor somnium. This programme is based on the~     guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online~     sessions. An animated personal sleep coach provides relevant audio-information and asks~     questions to which the patient is invited to respond. The components of the programme~     flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an~     instruction for sleep restriction, mementor somnium includes a cognitive restructuring~     intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the~     animated sleep coach, is based on a complex algorithm in the shape of an decision tree.~     University of Zurich's Department of Psychology in Switzerland will test the effectiveness~     of mementor somnium in a randomised controlled trial with three assessment times (pre,~     6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated~     randomly to either the active intervention group or the waitlist control group. Participants~     will have access to the programme mementor somnium for six weeks. Primary outcome measure is~     the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory~     revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally,~     sleep diary data will be collected.~   "
32666|NCT02628444|"~     The aim of the study is to assess the safety of the primary series vaccine schedules and the~     booster vaccination~      Primary Objectives:~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue~          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3~          dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue~          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3~          dose schedule (CYD Dengue vaccine group) 28 days post final vaccination.~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype 28 days after administration of a single booster dose of tetravalent CYD~          vaccine~      Secondary Objectives:~        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD~          vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the~          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine~          group) 28 days post-final vaccination.~        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD~          vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the~          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine~          group) 28 days post-final vaccination.~        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days post~          Dose 3 to the Ab levels immediately before receiving booster injection in all 3 CYD~          vaccination groups.~        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days~          post-dose 2 and 28 days post-dose 3 from CYD Dengue vaccine group in a primary series~          schedule.~        -  To demonstrate the superiority of the immune response elicited against each dengue~          serotype 28 days after administration of a single booster dose of tetravalent CYD~          vaccine.~        -  To evaluate the safety profile of CYD vaccine after each and any injection~   "
32634|NCT02629900|"~     Participants will complete a one-month intervention where they are will restrict their daily~     food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining~     16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to~     drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to~     maintain normal hydration. There will be no attempt to restrict food intake. Rather simply~     to restrict the time period each day when food is consumed. Participants' body mass, fat~     mass, and non-fat mass will be monitored non-invasively using a weigh scale and densitometry~     via air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also,~     participants will be interviewed following the final body composition measure to assess~     whether or not they continued to follow the intermittent fasting approach.~   "
32635|NCT02629887|"~     Prospective, randomized controlled trial to be performed at one center, of term and late~     preterm infants requiring resuscitation. Prenatal consent will be obtained. At~     randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP)~     guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or~     Non-inflating supraglottic airway. Video will be collected during resuscitation as well as~     written documentation. Primary outcome will be time to spontaneous breathing, length of~     resuscitation, and need for endotracheal intubation.~   "
32636|NCT02629874|"~     EA-230 is a newly developed synthetic compound with anti-inflammatory properties.~     Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation~     resulting from a variety of causes such as surgery, trauma, infection, irradiation and~     others. Although previous studies in healthy volunteers have shown an excellent safety~     profile, the safety and tolerability of higher doses administered per continuous infusion~     need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be~     further elucidated before a phase II trial in patients can be commenced.~   "
32637|NCT02629861|"~     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with~     episodic migraine~   "
32638|NCT02629848|"~     This study will evaluate progression free survival (PFS), overall survival (OS), objective~     response rate (ORR), duration of response, and safety of motesanib (AMG706) in combination~     with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and~     carboplatin.~   "
32639|NCT02629835|"~     Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route,~     intravenous (IV) or perineural (PN), remains controversial.~      This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary~     brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV~     counterpart. Since analgesic duration and sensory duration can be influenced by intake of~     pain medications and surgical trauma to small cutaneous nerves, the investigators will~     select motor block duration as the main outcome.~   "
32640|NCT02629822|"~     The primary objectives of this study are to evaluate the antiretroviral activity and to~     evaluate the safety and tolerability of open-label MK-1439A consisting of a single~     fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil~     fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI~     transmitted resistance mutations.~   "
32641|NCT02629809|"~     The goal of this clinical research study is to learn if the combination of ibrutinib,~     fludarabine, cyclophosphamide, and obinutuzumab can help control CLL. The safety of this~     drug combination will be also studied.~   "
32642|NCT02629796|"~     This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP~     patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of~     treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin~     vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6~     and 12 months after the first IVIG course. Responder/No responder status will be defined at~     3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course~     at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample~     will be collected to assess early changes of transcriptome. The CIDP diagnosis and~     responder/no responder status will be confirmed by an independent committee. The~     transcriptome of the patients will be individually analyzed and compared regarding~     Responder/Non responder status to a control groups of 20 healthy subjects~   "
32643|NCT02629783|"~     Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain~     among these patients can be increased due to their lack in BA. Psychomotor therapy is~     thought to improve BA and thereby increase the effect of traditional therapy, such as~     physiotherapy and exercises.~      The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting~     treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported~     on PRO's, compared to physiotherapy alone.~   "
32644|NCT02629770|"~     Treatment of bone and joint infections remains difficult and variable according to centres~     and countries. Clindamycin given intravenously and followed by an oral route is recommended~     for the treatment of staphylococcal, streptococcal and anaerobes bone and joint infections~     by the French Society for Infectious Diseases. For staphylococcal bone and implant~     infections, rifampin is a major drug, as it remains active in bacterial biofilm and on~     quiescent staphylococci. For that reasons, clindamycin-rifampin combination therapy is~     frequently used in these infections.Clindamycin is metabolized by the P450 3A4 cytochrome,~     an enzyme strongly inducible by rifampin. A retrospective study published in 2010 on 70~     patients treated for bone and joint infections showed that clindamycin serum concentrations~     were significantly lower when clindamycin was combined with rifampin (5.3 mg/liter vs 8.9~     mg/liter; p<0.02). This drug interaction could even be stronger with the oral route, because~     of hepatic first-past effect, ending up with very low clindamycin serum concentration, a~     risk of selecting resistant microorganisms and treatment failure. This latter point is an~     important issue, because clindamycin has an excellent oral bioavailability and is frequently~     used in oral regimens. In the above study, a wide variability of clindamycin serum~     concentration was observed in the group of patients treated with combination therapy~     (1-12mg/l) suggesting interindividual variability. Rifampin induction of CYP 450 3A4/A5~     depends on different receptor (PXR, RXR, LXRalpha) submitted to genetic polymorphism.~     Hypothesis: Plasma clearance of clindamycin (CLclin) combined with rifampicin (CLclinrif) is~     higher when clindamycin is administered by the oral route (CLclinrif OR) compared with IV~     administration (CLclinrif IV).~   "
32646|NCT02629744|"~     This study is a multi-center, single-arm, open-label study in healthy participants to assess~     the pain, tolerability, injection leakage, safety, and usability of a single~     self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive~     needle-experience training using a needle and syringe on Days -7 and -5, and health care~     professionals (HCPs) will then assess the participant's suitability to self-inject with a~     prefilled auto-injector (AI). The remainder of participants will be needle naïve and will~     not have previously self-injected. Eligible needle experienced and needle naive~     participants will attend an AI training visit at the study site on Day -3 (three days prior~     to etrolizumab dosing on Day 1). Following training and simulated injections by the~     participant the HCP will determine if the participant is suitable to proceed to actual~     etrolizumab dosing. All eligible study participants will self administer a single dose of~     etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain,~     tolerability, safety and usuability will be assessed.~   "
32647|NCT02629731|"~     This study will investigate the effect of foot orthoses on two common conditions (ankle~     osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system~     the group has developed to very accurately and precisely quantify foot bone motion. The~     investigators will vary the design of the orthoses and subjects will be examined to find out~     which are most effective at improving function.~   "
32648|NCT02629718|"~     To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase~     III, randomised controlled trial to compare NACT plus RS with RS alone in patients with~     stages IB2 and IIA2 cervical cancer.~   "
32649|NCT02629705|"~     The purpose of this study is to determine whether the ingestion of the common food additive~     carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2~     diabetes in humans.~   "
32650|NCT02629692|"~     Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706~   "
32651|NCT02629679|"~     Adolescent substance abuse (SA), which includes the consumption of alcohol, cigarette~     smoking, the consumption of drugs and other behaviors, is a significant public-health issue~     in the world today. Recent data showed that prevalence of SA among adolescents in Croatia~     and surrounding countries (i.e. former Yugoslav republics) is alarming and needs serious~     intervention. It is hypothesized that participation in physical-exercise-and-sport (PE&S)~     will reduce the tendency of young people to abuse substances. However, the literature to~     date has not consistently validated the perception PE&S factors are factors which could~     buffer SA among children and adolescents. One of the probable reasons for evident~     inconsistencies on findings about relationship between PE&S and SA is a cross-sectional~     nature of studies done so far. Therefore, the main rationale (i.e. problem) of this study is~     lack of current knowledge about influence of the PE&S on SA among adolescents. The main~     objective of this study is to prospectively investigate the influence of PE&S on SA among~     adolescents aged 17 to 18 years old. Aims of the project are: (1) to define prevalence and~     trends of SA among adolescents aged 17 to 18 years old; (2) to define prevalence and trends~     of PE&S participation; (3) to establish interrelationships which exist between~     socio-demographic, psychological, educational-factors, and PE&S (predictors); (4) to~     identify multivariate and univariate associations between: socio-demographic and SA,~     psychological factors and SA, PE&S and SA, educational - scholastic factors and SA.Expected~     results of the project are: (1) definition of the prevalence of SA among adolescents; (2)~     definition of the adolescents' participation in PE&S; (3) identification and interpretation~     relationships which exist between and within studied predictors of SA (educational factors,~     socio-demographic factors, PE&S, psychological factors); (4) identification of the influence~     of studied predictors on SA.~   "
32652|NCT02629666|"~     The increase of the elderly population leads to increased prevalence of frailty, risk for~     poor health outcomes, and related health and social care costs. Lack of physical activity~     (PA) and established sedentary behaviours (SB) constitute an additional burden, as they are~     related to progression of chronic disease and disabling conditions. An existing initiative~     to battle SB and insufficient PA levels are exercise referral schemes (ERS) implemented in~     primary care, where insufficiently active individuals are referred to a third party service~     (sports centre or leisure facility) that prescribes and monitors an exercise programme~     tailored to the patients' needs. ERS had shown improvements in PA in the short-term, but may~     have limited power to change SB and produce long-term effects. Thus, ERS might be enhanced~     by self-management strategies (SMS) to promote behavioural change. Such strategies based on~     social cognitive theory have been shown to increase self-confidence, power to act, and~     involvement in exercise. In a first stage, a systematic review, focus groups and a~     feasibility study will be conducted. Then, a three-armed pragmatic randomized controlled~     trial (RCT) will assess the long-term effectiveness (18-month follow-up) of a complex~     intervention on sedentary behaviour (SB) in an elderly population, based on existing ERS~     enhanced by self-management strategies (SMS). It will be compared to ERS alone and to~     general recommendations plus two educational sessions. The RCT will include 1338 subjects~     and will have a follow up of 18 months. The effect on SB will be measured as sitting time~     and the number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks,~     and PA as daily counts per minute and intensity of exercise, and daily step counts.~     Secondary outcomes will include: physical function, healthcare use and costs, anthropometry,~     bioimpedance, blood pressure, self-rated health and quality of life, activities of daily~     living, anxiety, depressive symptoms, social network, physical activity self-regulation,~     self-efficacy for exercise, disability, fear of falling, loneliness, executive function, and~     physical fatigue. In a subsample, the level of frailty-associated biomarkers and~     inflammation, and sarcopenia-associated markers of muscle quality will be analysed. A~     process evaluation will be performed throughout the trial. SITLESS will assess policy makers~     in deciding how or whether ERS should be further implemented or restructured in order to~     increase its adherence, efficacy and cost-effectiveness.~   "
32653|NCT02629653|"~     Aim of the study is to determine whether endovascular systemic cooling to a target~     temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy~     (CEA), is feasible and safe~   "
32654|NCT02629640|"~     The purpose of this study to investigate if cases of Creutzfeldt-Jakob Disease (CJD) and~     other forms of prion disease are being missed in older adults living within Lothian.~   "
32655|NCT02629627|"~     In Mexico, obesity is a major public health problem. In recent years he has presented a~     considerable increase in the population. As a result, it has triggered a proportional~     increase in the incidence of cardiovascular disease and the development of Metabolic~     Syndrome (METS). Abdominal obesity is one of the main components of METS which is generally~     associated with insulin resistance / hyperinsulinemia. This is influenced both by the~     subcutaneous adipose tissue as visceral adipose tissue. There is evidence that the visceral~     fat has an important bearing on many factors of METS, like: glucose intolerance,~     hypertension, dyslipidemia, and insulin resistance.~      For management it requires a multidisciplinary approach, including changes in lifestyle,~     psychological and nutritional intervention as well as pharmacological and~     non-pharmacological support.~      Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid~     (ACL) and leucine where in its assigned properties include weight reduction,~     anti-atherogenic , hypocholesterolemic and immunostimulant effect and anticarcinogenic~     properties. Regarding weight reduction dominates the mechanism of action anti-lipolytic~     effect. But, studies are needed to link this consumption with the increase or decrease on~     visceral fat in individuals with METS.~   "
32697|NCT02629237|"~     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma~          patients.~        2. Investigate the effect of educational intervention affect the degree of satisfaction in~          glaucoma patients.~        3. Investigate the effect factors of postoperative satisfaction.~   "
32656|NCT02628574|"~     This study will be conducted in 2 parts (Part A and Part B). Subjects ≥18 years with~     advanced solid tumors will be enrolled in the study. Dose escalation will be performed in~     Part A. Cycle 1 data from each cohort will be evaluated for safety and dose-limiting~     toxicities (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the~     order screening is completed. Dose will depend upon the cohort in which a patient is~     enrolled and cohorts will be dosed consecutively by ascending dose. Once the maximum~     tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an expanded~     cohort will be enrolled (Part B).~   "
32657|NCT02628561|"~     The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT)~     in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.~   "
32658|NCT02628548|"~     Normal aging is associated with gradual cognitive declines. These mild neurocognitive~     disturbances affect daily functioning, health status, and quality of life, and likely~     account for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of~     this project is to compare two different 8-week training programs to promote successful~     neural and cognitive aging. Changes in neural structure and cognitive function will be~     assessed in a cohort of older adults, as well as the long-term stability of these changes~     over 24 months.~   "
32659|NCT02628535|"~     The purpose of this study is to evaluate the safety of MGD009 when given to patients with~     B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009~     that can be given safely. Assessments will be done to see how the drug acts in the body~     (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity~     of MGD009.~   "
32660|NCT02628522|"~     Investigators performed a prospective pilot study to test the feasibility and safety of~     autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal~     fissures. The study included 6 patients with chronic anal fissures with symptoms that had an~     average duration of 24 months. All patients were candidates for surgical treatment as all~     previous conservative treatments were unsuccessful. The pain level was measured using the~     VAS scale and was recorded before the treatment and on every consultation following the~     treatment.~      The initial hypothesis is that application of ADRCs may be an alternative to lateral~     sphincterotomy and a reliable procedure to avoid fecal incontinence.~   "
32661|NCT02628509|"~     The WITAVI study was designed to explore the kinetic and associated outcome of Von~     Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.~   "
32662|NCT02628496|"~     The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser~     microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic~     assessment of laryngeal lesions.~      In order to achieve this purpose, this study will prospectively enroll patients with~     clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled~     to undergo a formal intraoperative biopsy of their lesion. While in the operating room,~     prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology,~     surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as~     per standard protocol, and the diagnostic results from CLM and the formal biopsy will be~     compared.~   "
32663|NCT02628483|"~     The health benefits of omega-3 fatty acids have been extensively examined in many published~     studies, and these benefits have been observed in patients with a diversity of conditions~     and diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis,~     thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline,~     periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to~     healthy individuals, in terms of preventative health benefits. The balance between omega-6~     long chain fatty acids and their omega-3 counterparts is important in health maintenance. An~     omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio~     in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014~     study of the dietary habits of U.S. adults revealed that, in general, North Americans do not~     meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to~     be considered, in order to help this population meet their daily needs. Both the Academy of~     Nutrition and Dietetics and the American Heart Association suggest a prudent approach in~     recommending an increased intake of omega-3 fatty acids. Although both organisations~     recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also~     recognise that supplementation may also be required in order to meet target values,~     particularly in at-risk populations.~      Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA~     and DHA and are available in varying forms including ethyl ester and high triglyceride~     forms. Differences in product formulation have been shown to have varying health effects.~   "
32664|NCT02628470|"~     Currently, there are many studies about the effects of manual therapy on pain, but there are~     not enough studies to know what are the mechanisms that cause these effects.~      Although there is a research measuring neuromodulators substances after a cervical and~     dorsal manipulation, it has been done in healthy subjects and there is no information about~     mobilization. This work aims to select a sample with chronic neck pain, incorporating the~     cervical mobilization as a therapeutic approach to compare the effects of both techniques~     because not all patients accept the manipulation as a treatment technique (mobilization is~     much better tolerated) and to verify that the liberation of cortisol is not just caused by~     the stress on the joint manipulation and the psychological stress and expectation may be~     important.~      The hypothesis of this paper is that cervical manipulation and mobilization in subjects with~     chronic neck pain there will increase salivary cortisol levels.~      It is also expected a little increase in the expectation of being manipulated group because~     of the psychological stress.~      It is expected an improvement in the neck disability, pain and range of motion in the~     intervention groups immediately after and in the three groups the following week after the~     exercise.~      The main objective of the study is to measure and analyze changes in salivary cortisol~     concentrations after the intervention in the three groups. Secondary objectives is to~     analyze the changes in range of motion and disability caused by neck pain neck pain level~   "
32665|NCT02628457|"~     There are two purpose of this study, first is to find whether arthroscopic rotator cuff~     repair is changing the appearance of supraspinatus muscle atrophy in each and every patient.~     Second, is to find how much approximate change one can expect depending on age and tendon~     retraction~   "
32667|NCT02628431|"~     The elfitor device is a small non invasive device that uses dynamic light scattering to~     measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this~     study, the investigators will investigate whether the elfitor device is able to detect~     changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the~     investigators will investigate changes in cutanuous blood flow in different parts of the~     body during peripheral nerve or neuraxial block.Being able to monitor these entities, under-~     and overdosing of general and local anesthetics may be prevented, resulting in favorable~     hemodynamics and better intra and postoperative pain relieve.~   "
32668|NCT02628418|"~     Hand recovery following cerebral stroke is complex and requires intensive training. The~     investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand~     rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand~     strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by~     stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized.~     Patients in the Treatment group received intensive hand training with Gloreha, a hand~     rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of~     the fingers, with multisensory feedback. Patients in the Control group received conventional~     intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity~     Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch~     test) were measured at baseline and after rehabilitation, and the differences between final~     and basal results were compared between groups.~   "
32669|NCT02629601|"~     This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness~     incentive program for physical activity to four other designs.~   "
32670|NCT02629588|"~     Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal~     and alertness for persons in a coma or persistent vegetative state after traumatic brain~     injury (TBI). Databases were searched and nine articles met inclusion criteria.~   "
32671|NCT02629575|"~     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex~     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions~     after stand-alone angioplasty in coronary arteries~   "
32672|NCT02629562|"~     Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD~     of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in~     healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.~   "
32673|NCT02629549|"~     The primary end-point of the study is to determine the specificity and sensitivity of OTL38~     in identifying pituitary adenomas when excited by an imaging probe. The investigators intend~     to enroll 50 patients in this study. The study is focusing on patients presenting with~     suspected pituitary adenomas who are considered to be good surgical candidates.~   "
32674|NCT02629536|"~     Migraine affects 15% of Western Australians and is a leading cause of suffering and~     disability in our community (1,2). Research suggests that inflammation of the brain's~     coverings (meninges) by nerve cell inflammation and the release of 'free radicals', is a~     cause of migraine. N-acetylcysteine, Vitamin E and Vitamin C are powerful anti-oxidants~     (free-radical scavengers) that reduce brain inflammation and nerve activity. It is therefore~     possible these anti-oxidants could reduce the number and severity of migraines. We will~     study 90 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and~     vitamin C 500 mg (NEC) taken twice daily for 3 months, will reduce migraine attacks. This~     safe vitamin-based therapy has never been studied and if effective, will play an important~     role in migraine prevention.~   "
32675|NCT02629523|"~     Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR~     mutations which were detected from circulating tumor DNA.~   "
32676|NCT02629510|"~     This study is aimed at identifying the efficacy of Tachosil® for prevention of hemorrhage in~     patients with cervical intraepithelial neoplasia or cervical cancer after undergoing a loop~     electrosurgical excisional procedure (LEEP).~        1. Primary endpoint:~           Bleeding period within two weeks after surgery Frequency of additional treatment due to~          bleeding within two weeks after surgery~        2. Secondary endpoint:~      Amount of bleeding within two weeks after surgery Infection frequency at external genitals,~     vagina and cervix within two weeks after surgery, Change in life quality after surgery~   "
32677|NCT02629497|"~     This study investigates the potential protective effects of fatty acid supplementation~     through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be~     evaluated for protection from agonist-mediated platelet activation in platelets from type 2~     diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and~     healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid~     supplements to determine protection from platelet activation and thrombosis in this high~     risk population.~   "
32678|NCT02629484|"~     Hip fracture surgery is a major world health care burden and concern, as it has a large and~     increasing prevalence and carries very high patient mortality, disability and community~     health care cost. As the commonest cause of mortality is from cardiac complications, and~     cardiac disease is prevalent and frequently missed by standard care, we hypothesise that~     earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will~     lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular~     technique used by doctors that enables earlier and more accurate diagnosis of cardiac~     disorders that can be performed routinely before hip fracture surgery. Our preliminary data~     of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac~     diagnosis and management in 50% of patients requiring hip fracture surgery, which was~     associated with a 50% reduction in mortality 12 months after surgery compared with controls.~     It is therefore important for a large randomised trial to be performed to confirm or rebuke~     these findings, as if true, would have a very large impact on health care and may also~     improve health care and outcome in other high-risk surgical populations. The proposed pilot~     study is a pilot study which aims to establish feasibility, safety, compliance and group~     separation prior to commencing a definitive multicentre trial.~   "
32698|NCT02629224|"~     The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in~     patients with impaired renal function and haemodialysis.~   "
32699|NCT02629211|"~     To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected~     IBD.~   "
32679|NCT02629471|"~     Background The goal of this study is to examine the human visual and cognitive performance~     under the effect of bright light pulses. Exposure to visual stimulation of such pulsation~     may interfere with cognitive function and at certain situations this may be noticeable and~     may interfere with our judgment and abilities. In some of them visual or cognitive~     impairment from exposure to bright light flashes may result in catastrophic outcome due to~     the high-risk situation e.g. road accidents. Ocular exposure to a bright light can result in~     profound momentary transitional loss of vision. The light sources employed for visual~     stimulation in this study will be restricted to the range consistent with reversible~     effects (e.g. glare and flash insensitivity or flash blindness).~      The impact of an exposure to bright light depends not only on the exposure level and~     frequency, but also on the exposed individual's activity, psychological state, adaptation~     level and visual task. Glare is primarily caused by the scattering of light within the eye~     due to the imperfect transparency of the optical components of the eye and to a lesser~     extent by diffuse light passing through the scleral wall or the iris. The scattered light~     overlays the retinal image, thus reducing visual contrast. Excessive glare may impair visual~     function and lead to temporary disability.~      The above mentioned effects of exposure to light and pulsating light stimulus on the visual~     system and cognition were studied in detail by a number of groups. These studies indicate~     that the visual and cognition effects of pulsating light are a function of the following~     parameters: pulse duration, light intensity and pulse frequency.~   "
32680|NCT02629458|"~     Stage I non-small cell lung cancer (NSCLC) is curable and surgery is considered the standard~     of care for fit, good performance status patients. However, a high proportion of patients~     with stage 1 NSCLC are elderly and/or have medical co-morbidities and are therefore at~     higher risk of surgical complications. The optimal treatment for these patients is unknown.~     SABR may be an equally appropriate treatment but this need to be formally assessed. Funded~     by the NIHR Research for Patient Benefit, SABRtooth is a UK multi-centre, two-group~     individually randomised controlled feasibility study of patients with peripheral stage I~     non-small cell lung cancer considered at higher risk from surgery. In total, 54 patients are~     planned to be recruited from 4 treatment sites and 2 referral sites. This study aims to~     determine the feasibility and acceptability of performing a largescale definitive randomised~     phase III trial comparing surgery with stereotactic ablative radiotherapy (SABR). The~     qualitative substudy is an exploration of the reasons for nonparticipation in the SABRTooth~     trial. As the two treatments are very different, patients may have a strong preference for~     either surgery or SABR, or may feel uncomfortable to have a decision between such distinct~     options taken out of their hands. Understanding why patients choose not to participate or do~     not take up their treatment allocation will be crucial in demonstrating that recruiting to a~     larger scale phase III trial is feasible. We will explore what patients, who have declined~     particpation in the study or who intiailly consented but subsequently fail to take up their~     randomimsed treatment arm, understand, perceive and feel about, how the SABRTooth trial was~     presented to them and their expectations of study burden.~   "
32681|NCT02629445|"~     People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia~     are routinely offered a defibrillator (ICD). An ICD is an implanted device which can~     recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the~     heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF,~     can only be treated with a shock. Patients find shocks painful and this study is intended to~     find out whether it is possible to pace the heart at very high rates during VF. It is hoped~     that if this is possible, further research could lead to effective treatment of VF with~     pacing rather than shocks, and therefore better outcomes for patients.~   "
32682|NCT02629432|"~     The main objective of this trial is to prove that MRI - as the imaging modality without the~     use of ionizing radiation - can replace CT for structural and functional regional~     phenotyping of COPD. The identification of different COPD phenotypes, such as the~     emphysema-type and the airway-type, is important because therapy and prognosis will be~     different. The medical problem addressed in this trial is the image-based phenotyping of~     COPD. The sensitivity and specificity of MRI will be compared to Lowdose-CT serving as the~     gold standard. MRI and CT of the lung will be performed in a multi-centre cohort of 625~     COPD-patients from the main COSYCONET cohort. The reliability of the MRI results will be~     demonstrated. MRI phenotypes will be evaluated visually and using software with quantitative~     read-outs. The agreement of both will be determined. The additional information of MRI over~     CT will be assessed.~   "
32683|NCT02629419|"~     This is an open-label, dose-titration trial to study the efficacy, safety, and~     pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous~     candidiasis infections in patients who are refractory or intolerant to standard non~     intravenous therapies.~   "
32684|NCT02629406|"~     The general aim of this study is to define the response to hypoxic challenge in patients~     with diabetes. The investigation will provide response for different questions that are~     central for explaining the development of complications in diabetes~        -  have patients with diabetes an impaired reaction to adapt to hypoxia~        -  what consequence has hypoxia challenge on respiratory and on cardiovascular regulation~          in patients with diabetes~        -  what consequence has diabetes on the angiogenetic response to hypoxia~   "
32685|NCT02629393|"~     To evaluate the safety and efficacy of ALXN1101 in neonate patients with MoCD Type A~   "
32708|NCT02629094|"~     Background:~      People with human immunodeficiency virus (HIV) are at a high risk of getting visceral or~     deep belly fat. Visceral fat can cause health problems like heart or liver disease.~     Researchers want to see if a blood pressure drug can help by blocking a hormone in the body.~      Objective:~      To see if eplerenone reduces fat stored in the heart muscle and liver in people with HIV and~     increased visceral fat.~      Eligibility:~      Adults ages 18 75 with HIV and increased waist circumference. Increased waist circumference~     is defined as more than 40 inches in men and more than 35 inches in women.~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Measurements of hips, waist, legs, arms, shoulders, and neck~      Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a machine.~      Electrocardiogram (EKG) to measure heart electrical activity~      Transient elastography, a special ultrasound to measure liver tissue stiffness~      A small piece their liver collected (optional)~      Participants will have a baseline visit:~      Physical exam~      Medical history~      Blood tests~      DEXA scan to measure body fat, muscle mass, and bone density. Participants will lie on a~     table while a very small dose of x-rays goes through the body.~      Resting energy expenditure (REE). This measures the amount of oxygen breathed in and carbon~     dioxide breathed out.~      Participants will get a 1-week supply of eplerenone. They will take one pill per day.~      Participants will have a follow-up visit 1 week later. They will have:~      Physical exam~      Medical history~      Blood tests~      23-week supply of eplerenone~      Participants will have 5 more follow-up visits.~      Participants will have a final study visit, repeating many of the screening and baseline~     tests.~   "
32686|NCT02629380|"~     The rational of intra-articular viscosupplementation is based on both the biological and~     mechanical properties of HA, which exerts positive effects on the modulation of the entire~     joint environment.~      The aim of the present double blind controlled study was to evaluate the effects in terms of~     pain control and functional recovery provided by a single intra-operative injection of HA~     performed at the end of arthroscopic partial meniscectomy.~      Patients included in this trial were randomized in two treatment groups: the first one~     received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy)~     at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery~     alone.~      All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the~     following evaluation tools: IKDC (International Knee Documentation Committee) subjective,~     VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury~     and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation~     and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both~     the operated and contralateral knee were documented; also in addition, the trans-patellar~     circumference of both knees was registered to assess the trend of knee swelling over time.~   "
32687|NCT02629367|"~     Currently, there are no data available regarding the effect of vorapaxar on clot generation~     kinetics or TIP-FCS when added to standard of care antiplatelet regimens. Potential~     reduction of TIP-FCS and clot generation kinetics by vorapaxar may assist in our~     understanding of the mechanism of action and in personalizing therapy in high risk patients~     to effectively reduce recurrent thrombotic event occurrences. The objective of this study is~     to determine onset-, maintenance-, and offset-effect of vorapaxar on platelet-fibrin clot~     generation kinetics by thrombelastography (R, TIP-FCS, TG) and thrombin generation kinetics~     (Lag time, peak thrombin production, time to peak thrombin generation, and endogenous~     thrombin potential) in antiplatelet naïve patients and patients on mono and dual~     antiplatelet therapy. This is a phase IV, prospective cohort (4 groups), non-randomized,~     open label, pharmacodynamics, and safety investigation.~   "
32688|NCT02629354|"~     The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg~     caffeine against 400 mg ibuprofen alone under fed conditions~   "
32689|NCT02629341|"~     The purpose of this study was to evaluate the therapeutic effect of a functional yogurt~     powder on menopausal, middle-aged women at high risk of osteoporosis. The functional yogurt~     powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus~     plantarum 3547 probiotic, was developed to benefit bone health and in the long term may~     contribute to the prevention of osteoporosis.~   "
32690|NCT02629328|"~     This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet~     repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the~     CardioCel implant.~   "
32691|NCT02629315|"~     This study evaluates the number of lymph nodes dissected in rectal cancer specimens~     following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Half of the~     specimens with be fixed in each solution.~   "
32692|NCT02629302|"~     The study investigates the effects of animal-assisted therapy on patients with severe~     disorders of consciousness. The focus lies on the short-term biopsychosocial effects that~     occur when animals are present during therapy sessions in comparison to therapy sessions~     without animals, observing a group of 10 patients during 16 therapy sessions.~      While half of the sessions are held in presence of an animal and half without, they are as~     comparable as possible with respect to content and setting. In this study, patients in a~     minimal conscious state are recruited.~   "
32693|NCT02629289|"~     This study is for healthy participants. This study tests single dose of the research drug~     HSP-130 against two existing approved drugs United States - approved Neulasta and European~     Union-approved Neulasta.~   "
32694|NCT02629276|"~     The aim of this study was to evaluate potential differences in somatosensory function in~     patients with unilateral NSNAP with and without positive ND compared to healthy controls.~     Furthermore, we determined whether there are any differences between groups in symptom~     severity, functional deficits, psychological parameters, quality of life and sleep.~   "
32695|NCT02629263|"~     Purpose of Study (The Effect of Viscous Fiber on Glycemic Control (VF & GC) in Individuals~     with Diabetes Mellitus According to the World Health Organization, about 347 million~     individuals are living with diabetes.~     (http://www.who.int/features/factfiles/diabetes/facts/en/, accessed on Nov. 23, 2015). Over~     the last decades, dietary fibers, namely dietary viscous fibers, have emerged as a nutrition~     component that may improve the postprandial glycemic response and hence aid in long term~     diabetes management. It is believed that supplementation with viscous fibers can control~     blood glucose by increasing viscosity of the gastric digesta, hence delaying gastric~     emptying and retarding entry of glucose into the bloodstream to result in a diminished~     postprandial rise in blood glucose. (Chutkan et al., 2012).~      Currently, the evidence of the relationship between viscous fibers and diabetes is mixed.~     The systematic review method depends on combining data from many small studies in order to~     get a pooled estimate of the true effect. The purpose of this study is to conduct a~     systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the~     fasting glycemic and insulinemic effect of viscous fiber supplementation. We hope the~     findings of this study will play a key role in developing the nutritional guidelines for~     individuals with diabetes mellitus.~   "
32696|NCT02629250|"~     Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop~     more complications following major surgery. Quite a few researches have shown the benefits~     of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve~     outcome during major surgery. However there is concern that inotropic therapy for a~     supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial~     ischemia. Even though the meta-analysis has stated that DO2I strategy could possibly reduce~     the incidence of cardiac complication than stroke volume optimization strategy, there are~     very few evidence available in the literature regarding the effect on myocardial ischemia in~     surgical patients, especially in non-cardiac surgical patients. This study is undertaken to~     test the hypothesis that an intraoperative DO2I optimization result in a decreased~     myocardial ischemia in the elderly high-risk surgical patients.~   "
34902|NCT02600130|"~     This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study~     designed to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for~     the treatment of subjects with clinically diagnosed Alzheimer's disease.~   "
32700|NCT02629198|"~     There is current interest in the role of vitamin D in the prevention and treatment of many~     chronic diseases, including osteoporosis, cancer and neurological disease. The majority of~     vitamin D in the UK comes from the action of sunlight on skin, and very little from dietary~     sources. Half of the adult United Kingdom (UK) population have vitamin D insufficiency~     (according to the Institute of Medicine definition). There are still several important~     unknowns, including what the optimum levels of vitamin D are, and whether the same intake of~     vitamin D is appropriate for all sections of the population.~      Low 25(OH)D and high parathyroid hormone (PTH) have been observed in people with high~     adiposity (obesity), and the summer rise in vitamin D is blunted in obesity. The potential~     causes of low 25(OH)D levels include an inadequate supply of vitamin D (by reduced sunlight~     exposure or poor nutrition), the large pool size of adipose tissue or increased metabolic~     clearance rate.~      The investigators will measure metabolites of vitamin D and the kinetics of 25(OH)D using~     stable isotope techniques in lean, overweight and obese men, women and children to establish~     whether age, gender and obesity affect vitamin D metabolism and clearance rate.~      If low 25(OH)D in obesity is related to poorer skeletal health and is due to increased~     clearance of 25(OH)D or large pool size, then total requirements, and hence supplementation~     requirements, would be larger for obese people than for lean people.~   "
32701|NCT02629185|"~     High body weight is protective against hip and spine fracture, but has been found to~     increase the risk of humerus, foot and ankle fracture. Increasing understanding of the~     actions of adipokines on bone suggests that there may be complex effects on different~     aspects of bone geometry and microarchitecture and that these effects may vary depending on~     whether adipokines act directly on bone cells or through the central nervous system and~     between cortical and trabecular compartments. Previous research is limited by the use of~     areal dual-energy x-ray absorptiometry (DXA) scans which may be inaccurate in obese~     populations due to increased body thickness.~      The aim of this study is to investigate the effect of obesity on bone mineral density, bone~     geometry, bone microarchitecture and bone strength of the hip, lumbar spine, distal radius~     and tibia.~      This is an observational, cross-sectional study of normal weight and obese individuals~     matched by age, gender, height, postcode and smoking. The total number of subjects will be~     240; men and premenopausal women ages 25 to 40 years and men and postmenopausal women ages~     55 to 75 years. DXA, high-resolution peripheral computed tomography (HR-pQCT), quantitative~     computed tomography (QCT) and finite element analysis will be used to assess bone structure~     and strength. Biochemical markers of bone turnover and hormones related to bone metabolism~     will also be measured in order to identify potential mediators of the effects of obesity on~     bone structure and strength.~      A sub-study has been included to evaluate the interaction of fracture risk and~     cardiovascular risk in obese and non-obese individuals. There is evidence of an interaction~     between bone mineral density (BMD) and cardiovascular risk and test the hypothesis that~     there are common pathways linking BMD and cardiovascular risk, including fat secretion of~     inflammatory cytokines e.g. interleukin-1 and adipokines e.g. leptin and adiponectin.~     Ultrasound based assessments of vascular function will be used to assess cardiac risk and~     relate these measures to bone density.~      Obese individuals have lower circulating levels of 25OHD. This may be due to poor~     nutritional intake, reduced sunlight exposure or the vitamin D being stored in fat tissue.~     The investigators will measure levels of 25OHD in lean, overweight and obese men and women~     to examine whether 25(OH)D is related to age or gender and whether low 25OHD in obesity~     affects bone health in subsets of lean, overweight and obese participants of different ages.~   "
32702|NCT02629172|"~     The main objective of this study is to evaluate the safety and effectiveness of~     paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily~     practice in Japan.~   "
32703|NCT02629159|"~     This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to~     Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a~     stable background of Methotrexate (MTX) and who have an inadequate response to MTX.~   "
32704|NCT02629146|"~     This study evaluates analgesic properties of midazolam compared to placebo and fentanyl.~     Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three~     different occasions (study visits) and the effect on different pain stimuli will be tested.~   "
32705|NCT02629133|"~     This study will develop and assess an innovative, high-reach, easily implementable, low-cost~     computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that will~     address known barriers in early identification and intervention with sheltered battered~     women with IPV (intimate partner violence) and substance use.~   "
32706|NCT02629120|"~     Chronic granulomatous disease (CGD) affects white blood cell function. Currently, the only~     curative treatment is bone marrow transplant to replace the abnormal stem cells with new~     ones (donor cells) capable of making a normal immune system. Transplant problems include~     graft versus host disease (GvHD) and graft rejection. With GvHD, donor cells attack the~     recipient s normal tissue. Researchers want to use preparation drugs and a high cell dose to~     increase graft success. They want to use 2 immunosuppressive drugs (cyclophosphamide and~     sirolimus) to lessen the risk of GvHD.~   "
32707|NCT02629107|"~     Background:~      An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the~     louder the sound needed to wake a person, the deeper the person s sleep. Researchers are~     using functional magnetic resonance imaging (fMRI) to study people during sleep so they can~     view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like~     the EEG.~      Objective:~      To measure brain activity during sleep using fMRI and EEG.~      Eligibility:~      Healthy people ages 18 34 who can sleep on their back for several hours.~      Design:~      Participants will be screened online about their sleep and general health.~      At a screening visit, participants will have:~      Physical exam~      Hearing exam~      MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants~     will lie down on a bed that slides into the scanner, which is shaped like a cylinder.~      Participants will wear an actigraph on their wrist that records their motor activity.~      Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed~     times and limits on alcohol, caffeine, and nicotine.~      At the 3-day inpatient visit, participants will have:~      Hearing exams.~      Female subjects will have a urine pregnancy test.~      fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer~     screen inside the scanner.~      EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in~     the scanner.~      Participants will be asked to try to sleep while researchers collect fMRI and EEG data.~     Participants eyes will be monitored with a video camera. Headphones will deliver sounds to~     wake them up throughout the night.~   "
32732|NCT02628782|"~     The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery~     access sites for quick hemostasis and ambulation in patients who have undergone large bore~     endovascular catheterization procedures.~      The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the~     study population.~   "
33363|NCT02620358|"~     This study compares two opposite strategies of weaning from Mechanical Ventilation. One of~     them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2~     hours. The aim of the study is to know witch one has a higher successful extubation rate.~   "
32709|NCT02629081|"~     When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not~     respond to conventional treatment (a class of medications called proton pump inhibitors), it~     is important to be able to distinguish between erosive GERD and non-erosive GERD (called~     NERD).~      Currently the best method the investigators have to make this distinction is esophageal~     24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus~     through the nose and having the catheter maintained in this position for 24 hours This test~     is invasive, can be uncomfortable, and it is expensive and time consuming.~      The investigators are hoping that image enhanced technology will identify characteristics~     that are found more commonly in patients with non-erosive GERD compared to controls and~     therefore provide evidence that may allow us to replace pH and impedance testing with the~     image enhanced endoscopy as the best way to diagnose NERD.~      Participants will be either patients undergoing an upper endoscopy as part of their standard~     clinical evaluation for heartburn that does not respond to PPIs or patients undergoing~     standard clinical evaluation endoscopy for other reasons.~   "
32710|NCT02629068|"~     The purpose of this study is to develop and test a social media-based (Facebook)~     intervention that provides support and skills to parents with adolescent children in~     treatment for substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and~     led by other parents (peer leaders). Peer leaders will go through 2 2-3-hour training~     sessions and be assessed at the end to confirm their understanding of study protocol and~     procedures. The study PI will lead 2 short (2-weeks) trial tests of various segments of the~     intervention to test out content and procedures. Then, a pilot trial with 80 parents, 40~     randomized to PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test~     how useful PURPOSE can be in promoting parents' engagement in their child's treatment and~     recovery while reducing their own distress and feelings of shame/stigma. Parents will do a~     phone interview at the start of PURPOSE and again at the end of the 8 weeks.~   "
32711|NCT02629055|"~     The aim of the present study is to investigate whether additional titration on surface~     electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of~     chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic~     respiratory failure in terms of better gas exchange after six weeks, lung function, patient~     comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators~     set up a randomized, two-armed crossover trial comparing regular titration with additional~     respiratory EMG titration of NIV.~   "
32712|NCT02629042|"~     Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful,~     representing one of the main reasons for consulting dental emergency. The recommended~     emergency care is a partial endodontic treatment under local and/or locoregional anesthesia.~     The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by~     removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours~     after. The literature reports major difficulty in obtaining adequate anesthesia in the~     mandible to perform partial endodontic treatment, especially for the mandibular molars. This~     results in a very painful care for the patient. The management of this type of emergency is~     costly in terms of equipment and time for health facilities. Patient comfort, cost saving~     and rationalization of the care time justify the search for an alternative to emergency~     partial endodontic treatment. In current practice, the short course oral corticotherapy is~     used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to~     their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The~     pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local~     steroid injection for irreversible pulpitis of mandibular molars has already been shown but~     results in local comorbidities and requires specific device. Oral administration of~     short-course prednisolone is simple and safe but its effectiveness to manage pain caused by~     irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone~     has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness~     between intravenous and oral administration of this molecule was reported. This oral~     treatment could limit comorbidities and technical difficulties related to intraosseous~     injection and could delay the endodontic treatment to 72 hours in optimal conditions of~     anesthesia for the patient. Despite the difficulties described for the partial endodontic~     treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a~     non-inferiority design was chosen to compare the effect of a short-course oral~     corticotherapy to a partial endodontic treatment for the reduction of pain at the emergency~     care of the irreversible pulpitis in mandibular molars. The intervention arm will receive an~     oral dose of prednisolone (1 mg/kg) during the emergency visit followed-up by one morning~     dose by day during three days and the reference arm will have partial endodontic treatment.~     Both groups will have planned complete endodontic treatment 72 hours after enrolment.~   "
32713|NCT02629029|"~     Surgical reconstruction of anatomical structures after head and neck cancer resection has~     made enormous strides in the past 20 years with advancing flap techniques and the usage of~     perforating vessels, but accurate and consistent identification of these perforators has~     remained a challenge due to the varying anatomy of vasculature in the donor region. Computed~     tomography angiography (CTA) has been used increasingly in preoperative free flap perforator~     mapping for breast reconstruction but has been limited in head and neck applications. In~     addition, indocyanine green (ICG) assisted NIR fluorescence angiography has been developed~     for intra-operative flap assessment. In this study, the investigators propose to assess a~     previously undocumented, multi-modal imaging technique with preoperative dual energy CTA to~     design and intraoperative ICG assisted NIR angiography to assess free flap in head and neck~     reconstruction.~   "
32714|NCT02629016|"~     This study will evaluate the feasibility of providing an onsite mindfulness intervention,~     delivered as part of the school health curriculum, to help high school-attending adolescents~     cope with stress.~   "
32715|NCT02629003|"~     The purpose of this study is to determine the dosimetry for the Positron Emission Tomography~     (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information~     will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11~     labelling position.~   "
32716|NCT02628990|"~     The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol~     ester either with or without added camelina oil on the serum cholesterol levels in~     moderately hypercholesterolemic subjects~   "
32717|NCT02628977|"~     The primary purpose of this study is to ascertain the effectiveness of tailored, peer based~     sleep health education and social support in increasing adherence rates to recommended~     Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive~     Sleep Apnea.~   "
32718|NCT02628964|"~     The purpose of this study is to examine the feasibility of using e-cigarettes as a method~     for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on~     smoking outcomes. Participants will be randomized to receive either e-cigarettes with~     nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.~   "
32745|NCT02628613|"~     The purpose of this study is to compare the efficiency and safety between paclitaxel~     combined with carboplatin and vinorelbine combined with epirubicin when used in neoadjuvant~     chemotherapy for locally advanced (IIb-IIIc) HER-2 (-) breast cancer with TEKT4 variation.~   "
33364|NCT02620345|"~     Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and~     women pregnancy to lost the size fibroids.~   "
32719|NCT02628951|"~     Vascular endothelial growth factor is expressed in gastric cancer, and expression has been~     associated with more aggressive clinical disease. Vascular endothelial growth factor~     expression has been noted in 51% of gastric cancer specimens in one series (versus no~     expression in normal epithelium or superficial gastritis). Vascular endothelial growth~     factor expression in resected gastric cancer is associated with tumor recurrence and shorter~     survival. Maeda et al. studied 95 gastric cancer patients following resection with curative~     intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium~     expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial~     VEGF expression (p<0.05). Yoshikawa and colleagues observed similar survival differences in~     resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of~     resection. Circulating VEGF is significantly higher in gastric cancer patients versus those~     without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a~     European cohort undergoing gastric cancer resection; there was no survival beyond 30 months~     in 24 patients with serum VEGF >533 pg/mL versus a 30-month survival rate >35% for 34~     patients with VEGF levels below this threshold (p<0.0001, log-rank test). Recently, Jüttner~     and colleagues noted reduced survival following R0 resection in gastric cancer patients~     whose tumors expressed VEGF-C or VEGF-D, with the most robust association between expression~     and reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D.~      Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line)~     is associated with reduced tumor growth. DC101 therapy in this model is associated with~     significant reductions in tumor vascularity (as measured by CD-31 expression) and increases~     in endothelial and tumor apoptosis.~      The results of the REGARD and RAINBOW studies are consistent with the idea that tumor-~     related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate~     the ability of ramucirumab to represent an improvement in the care of patients with gastric~     cancer whose disease has progressed after prior chemotherapy.~   "
32720|NCT02628938|"~     The aim of this experiment is to investigate the effect of Miswak on oral malodor and to~     determine whether this effect -if present- is the result of the mechanical action of Miswak~     or the chemical effect of its extract~   "
32721|NCT02628925|"~     Delirium is one of the most common complications among elderly hospitalized patients,~     postoperative patients and patients on intensive care units. The reported prevalence is~     between 11 and 80 %. Delirium is associated with a high morbidity and threefold higher~     6-month mortality. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with a~     high sensitivity and specificity.~      The purpose of this study is to translate the Nu-DESC to danish and evaluate afterwards its~     feasibility and understanding by different medical staff.~      Material and methods:~      The Nu-DESC will be translated after International Society for Pharmacoeconomics and~     Outcomes Research (ISPOR) guidelines to Danish by permission of the original author.~      The evaluation will be performed, by filling out evaluation forms, where the feasibility and~     understanding will be rated on a 6 step Likert scale.~   "
32722|NCT02628912|"~     This study is being done to learn about how the participants lungs and heart are working~     after treatment for throat cancer. The investigators are looking to see if there is a~     long-term impact on overall health from the cancer treatment. The long-term goal of this~     study is to compare the participants overall quality of life to similarly aged people who~     have not had throat cancer.~   "
32723|NCT02628899|"~     To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with~     commercially available bioprostheses in elderly patients with severe, symptomatic aortic~     stenosis (AS) who are low‐risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).~   "
32724|NCT02628886|"~     Streptococcus pneumoniae is responsible for over 10 percent of death in children under five~     and many of these deaths occur in early infancy before the current pneumococcal schedule is~     effective and nearly half occur in sub Saharan Africa.~      The PROPEL trial will examine the effect of either a maternal or a neonatal dose of a~     pneumococcal conjugate vaccine on pneumococcal colonisation in the nose which can be used to~     measure the risk of disease in early life.~      600 Expectant mothers will be randomized at between 28 and 34 weeks to a maternal group, a~     neonatal group or a control group in equal number (200 per group). Their subsequent born~     offspring will be followed up until nine months of age. Infants born from expectant mothers~     in the maternal and control group will receive their subsequent pneumococcal conjugate~     vaccination according to the national Expanded Programme on Immunisation (EPI) schedule in~     the Gambia at 8, 12 and 16 weeks while infants born to expectant mothers in the control~     group will receive the pneumococcal conjugate vaccine within 48 hours of birth and at 8 and~     16 weeks of life. Randomization will be undertaken by defined un-blinded members of the~     clinical trial team who will be delegated for this task and who will not be involved in any~     other trial related procedures Pregnant women who are willing and who are identified by the~     staff of the government antenatal clinic as being potentially eligible according to~     gestation (assessed initially according to the date of the last menstrual period (LMP) - if~     known, or the fundal height), will be referred to a member of the clinical trial team.~      Those who remain interested in participation having had the details of the study explained~     will have basic demographic, obstetric and contact details collected and will be invited, at~     a time of their convenience, to the Medical Research Council (MRC) clinical trial site for~     the formal informed consent process to be completed. Following informed consent, pregnancy~     will be confirmed with a urinary pregnancy test. Initial screening (e.g. for past-obstetric~     history and past-medical history etc) will be undertaken at this point along with screening~     bloods for serology (HIV, hepatitis B and syphilis) and haematology (haemoglobin and sickle~     test). A dating ultrasound scan (USS) will also be undertaken by designated clinical trial~     staff. On completion of screening, expectant mothers who are confirmed to be eligible~     according to the defined inclusion and exclusion criteria will be enrolled and randomized in~     parallel into one of three equally sized groups mentioned above (maternal, neonatal,~     control).~      According to the group into which they have been randomized, mothers will receive a dose of~     PCV13 and tetanus toxoid [maternal group], placebo (0.9% sodium chloride) and tetanus toxoid~     [control group] or tetanus toxoid alone [neonatal group]. From this point on, the maternal~     and control groups (now 'Routine EPI Schedule') will be followed up in exactly the same way~     for the purposes of interventions and all endpoint assessments. Infants in the neonatal~     group ('Neonatal Schedule') will be followed up according to the schedule outlined.~      At the time of presentation to the delivery unit a blood sample for serology and malaria~     Rapid Diagnostic Test (RDT) and an nasopharyngeal swab (NPS) sample will be obtained prior~     to or shortly following delivery. Immediately following delivery a sample of cord blood will~     be obtained and as soon as possible an NPS sample will be taken from the newborn.~     Anthropometric measurements will be taken from the newborn and an examination conducted.~     Once there has not been any contraindication to vaccination identified, all newborns will be~     administered the routine EPI vaccines according to the schedule in The Gambia (BCG,~     Hepatitis B and OPV). Those newborns in the Neonatal group will additionally be administered~     a single intramuscular (IM) dose of PCV13. At two, three and four months, infants will be~     administered the routine EPI vaccines. Those infants in the Maternal and Control Groups~     (Routine EPI Schedule) will additionally receive PCV13 at eight, 12, and 16 weeks while~     those in the Neonatal group will receive the vaccine at eight and 16 weeks only having~     received the first dose at birth. All infants will additionally receive a single dose of the~     inactivated poliovirus vaccine (IPV) at 16 weeks in line with the routine EPI schedule in~     The Gambia.~      Following the vaccines administered to expectant mothers and following the vaccines~     administered at birth, home visits will be undertaken on day 1 to 6 to collect solicited~     local and systemic adverse (for PCV only) reactions and any unsolicited. A day 7 safety~     clinic visit will be conducted following the vaccines administered to expectant mothers and~     following the vaccines administered at birth. Infant will attend the clinical trial site for~     NPS and blood samples to be taken at specific time points.~   "
32725|NCT02628873|"~     The study evaluates whether saline infused sonography (SIS) with directed air bubbles for~     hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray~     hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in~     patients who are undergoing an Essure confirmation test.~   "
32726|NCT02628860|"~     This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing~     perioperative transfusion in iron deficiency anemia patients anticipating~     pancreatoduodenectomy.~   "
32727|NCT02628847|"~     This is a small, pilot randomized clinical trial of administering sildenafil citrate to~     individuals within 10 days of ischemic stroke who have motor impairment and who are~     undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor~     recovery at one and three months.~   "
32728|NCT02628834|"~     Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be~     participants of the study.Following the initial evaluation, participants with multiple~     sclerosis will take the fascial mobilization for their posterior crural muscle group and~     hamstring distal tendons which connects the crural bones at first day. After the day~     following the first visit participants will asked to come again and stretching exercises~     will apply to plantar muscle groups after the evaluation. Every participants will evaluate~     with the following assessment tools: Modified Ashworth scale will use to evaluation of~     severity of plantar flexor spasticity. Static and dynamic loading parameters will assess~     with dynamic pedobarography.~   "
32729|NCT02628821|"~     Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of~     gestation from January 2012 to December 2015. Previous respiratory status is analyzed as~     well as respiratory outcomes and possible secondary side effects.~      SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants~     that met intubation criteria) and also is used electively for extubation when nCPAP~     extubation has previously failed or infants with Prolonged mechanical ventilation (more than~     15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).~   "
32730|NCT02628808|"~     The main objective of the study is to define, for Autism Spectrum Disorder, the extent of~     genetic variation in synaptic pathways that may be targeted for therapeutic development. For~     this purpose the investigators will take advantage of large, well-characterized cohorts of~     patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of~     selected synaptic genes, previously associated with Autism Spectrum Disorder, will be~     carried out in these cohorts with deep coverage of coding regions and a strong focus on~     previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome~     sequencing and exome sequencing, available for some of these patients, will be integrated in~     the overall analysis. The investigators will strongly emphasize the establishment of~     comprehensive genotype/phenotype correlations and set up an induced Pluripotent Stem Cells~     collection from selected patients with synaptic mutations for functional and expression~     analysis.~   "
32731|NCT02628795|"~     This single-blind, randomized, controlled trial is designed to test the effect of an~     intensive, 16 week exercise rehabilitation program (progressive resistance training +~     functional mobility training) vs. usual care on restoration of muscle mass and mobility~     after total hip (THA) or knee (TKA) arthroplasty in men and women with end-stage~     osteoarthritis. The molecular basis underlying the trial is the presence of significant~     muscle inflammation susceptibility in many of these individuals, and the expectation that~     the more intensive intervention will overcome this inflammatory burden to facilitate~     recovery.~   "
32733|NCT02628769|"~     This study examines the potential benefit of a new antibiotic, Solithromycin, for the~     long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is~     hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable~     COPD patients will receive treatment with solithromycin for 28 days and comparisons will be~     made between any effects observed with Solithromycin and a placebo. This will include any~     changes in inflammatory proteins, lung function and reported symptoms.~   "
32734|NCT02628756|"~     Women between 18-39 years old who had been infertile (primary or secondary) for at least 1~     year were recruited. In a parallel assignment eligible participants were randomized to~     receive either a single, site-specific endometrial injury guided by hysteroscopy (Study~     group) or no intervention (Control group). Natural cycle folliculometry + timed sexual~     intercourse were offered for all participants for the ongoing and the immediate 2~     concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates~     were the secondary outcome measures.~   "
32735|NCT02628743|"~     The purpose of this study is to evaluate the safety of olesoxime in participants with spinal~     muscular atrophy, focusing on the nature, frequency, and severity of adverse events, as well~     as effects on laboratory values, vital signs and ECG parameters.~   "
32736|NCT02628730|"~     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart.~     Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have~     devised a treatment called catheter ablation in which special wires are used to deliver heat~     energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many~     patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF~     recurrence. Many of these patients then need a second procedure to deliver further ablation~     at these recovered areas.~      Recent research has shown that monitoring of heat delivery with a factor called Ablation~     Index may be useful in predicting which ablation lesions are less likely to recover.~     Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe~     whether this will be associated with better durability of ablation lesions, and thereby~     better freedom from AF.~      This study will include patients with persistent AF, those whose AF episode(s) last for~     longer than seven days. All patients participating in the study will undergo an initial~     ablation treatment guided by ablation Index . All patients will undergo a repeat procedure~     8-10 weeks after their initial treatment. Any gaps found during the second procedure will be~     closed again by delivery of ablation.~      All participants will be issued with a simple to use handheld heart rhythm monitor, and~     asked to make a 30-second recording of their heart rhythm each day and also whenever they~     have symptoms. The monitor stores these recordings and they will be downloaded at review~     appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation~     procedure.~   "
32737|NCT02628717|"~     Since the availability of interferon free direct acting antivirals (DAA) the centers~     authorized to prescribed these drugs in Austria submitted their data to a central data base~     (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced~     liver disease (F3/4)~   "
32738|NCT02628704|"~     Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib~     (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose~     dexamethasone in patients with relapsed/refractory multiple myeloma.~   "
32739|NCT02628691|"~     Data on the progression of liver fibrosis in patients co-infected with HIV taking effective~     suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline~     are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier~     (than F3-F4) treatment in co-infected patients.~      Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the~     opportunity to monitor for short-term fibrosis progression in a cohort of co-infected~     patients with initial no-to-moderate fibrosis being identified during another ongoing study~     (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV~     treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.~      The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized~     follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C~     disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk~     Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2,~     -3 or -6 but are not considered in immediate need of HCV treatment.~      All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk~     hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV~     infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis~     stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for~     inclusion and invited to participate.~      Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be~     enrolled in this study.~      Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24~     months. These patient visits will comprise of a history taking and physical examination~     focused on hepatic disease and blood sampling for basic hematologic and hepatic function~     parameters. Additionally, patients will be referred every year for ultrasound and transient~     elastography measurements and sampling for some additional liver function tests and~     measurement of HCV-RNA viral load.~   "
32740|NCT02628678|"~     The primary objective of this study is to determine the 5-day tolerability of one~     commercially available prebiotic food ingredient, FOS, in healthy human subjects with and~     without diet control.~   "
32741|NCT02628665|"~     The therapy of photofrin PDT was effective in improving life quality of patients with~     advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing~     laser irradiation was of great importance.The purpose of this study is to evaluate the~     clinical efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or~     gastric cardiac cancer during different time after inject photofrin.~   "
32742|NCT02628652|"~     The primary objective of this study is to determine the tolerability of two polyglycan food~     ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator~     in this study will be Inulin FOS, a commercially available glycan supplement.~   "
32743|NCT02628639|"~     The purpose of this study is to evaluate whether personalized stimulations can improve the~     detection of electrophysiological signs of awareness in patients with disorders of~     consciousness.~   "
32744|NCT02628626|"~     Fecal incontinence (FI) is a common symptom that can significantly impair quality of life.~     There is very limited, mostly uncontrolled, evidence to support the approaches currently~     used to manage FI. The alpha-2 adrenergic agonist clonidine decreased the frequency of loose~     stools in FI patients with diarrhea. Among patients with diarrhea, clonidine decreased the~     proportion of days with FI; however results were not statistically significant. Uncontrolled~     studies suggest that the bile acid binding resin colesevelam also increased stool~     consistency in patients with functional diarrhea. In this study, the investigators propose~     to compare the effects of a combination of colesevelam and clonidine to placebo on bowel~     symptoms in patients with urge or combined type of FI. The investigators hypothesis is that~     combination treatment with clonidine and colesevelam is better than placebo in reducing~     stool frequency and rectal urgency in FI.~   "
32747|NCT02628587|"~     Ischemic heart disease is the leading cause of death and disability in developed countries~     and is responsible for a third of deaths in persons over 35 years . The most severe form of~     ischemic heart disease is sudden death and acute coronary syndrome (ACS).~      There is evidence that early and optimal treatment of ACS decreases mortality. Within the~     optimal treatment, these patients must receive a reperfusion therapy as mechanical or~     pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a~     central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease~     mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor;~     however, it has been shown to have a wide variability in response and this variability could~     be influenced by different pharmacological, genetic and environmental factors.~      Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS~     patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel~     efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity~     in patients with ACS receiving clopidogrel generic versus patent.~   "
32748|NCT02628405|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in~     treating patients with diffuse large B-cell lymphoma that has returned after a period of~     improvement and that has not responded to previous treatment. Biological therapies, such as~     lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer~     cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better~     treatment for patients with diffuse large B-cell lymphoma.~   "
32749|NCT02628392|"~     The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a~     compared with placebo in patients with type 2 diabetes mellitus.~   "
32750|NCT02628379|"~     The goal of the current study is to determine whether Foundation Medicine's next generation~     sequencing assay, called FoundationOne, will provide information that allows physicians to~     make treatment decisions using targeted therapies in clinical trials or FDA approved~     therapies, including off-label agents, that result in superior OS compared to historical~     outcomes for standard CUP therapy.~   "
32751|NCT02628366|"~     People with failed kidneys need an artificial kidney machine (called dialysis) to remove~     toxins and extra fluid from the body. Most patients receive dialysis treatments at a~     hospital three times a week. During treatment, a patient's blood pressure may drop, causing~     dizziness and muscle cramping. Repeated drops in blood pressure can also injure the heart~     and brain. Over time, this can lead to heart attacks, strokes, and sometimes death. New~     research shows that cooling the temperature of the dialysis fluid (called dialysate) can~     reduce heart and brain injury. In most hospitals, all patients' dialysate temperature is set~     at 36.5 ºC (to match body temperature). In our study of 73 patients, we showed that reducing~     the dialysate temperature to 0.5 ºC below body temperature protected the heart and brain~     from injury [1,2]. We now want to test this simple, safe, low-cost intervention in a large~     study with more than 7000 dialysis patients in Ontario. We can lower the dialysate~     temperature on dialysis machines in Ontario at no added cost. This intervention has the~     potential to reduce many hospitalizations and deaths in Ontario, and relieve suffering in~     patients with kidney failure.~   "
32752|NCT02628353|"~     The study's main objective is to investigate the effects of acute consumption of a~     preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587)~     on systolic BP after ingestion of a high fat meal.~   "
32753|NCT02628340|"~     HIV infection can be efficiently controlled by antiretroviral therapy (ART), with in 2013~     nearly 85 % of patients having a suppressed viremia, but HIV cannot, however, be eradicated~     with ART alone [1]. Overall, HIV has moved from a fatal to a chronic disease provided~     treatment is maintained life-long. Despite major improvement in antiretroviral drugs in~     terms of efficacy, tolerability and simplicity, life-long therapy is still associated with~     drug toxicity. Several drugs or drug classes, which have historically saved lives since 1996~     and are currently widely used such as protease inhibitors and nucleosides analogues, are~     associated with long-term toxicities and increased incidence of comorbidities.~      Currently, worldwide there is an approximated 10 millions of HIV infected patients under~     cART. This number should increase in the next years, as most recent guidelines recommend~     earlier therapy given the benefits in terms of disease progression and prevention of~     transmission. Because of the increasing number of patients who will be under cART in the~     future, the cumulative ART toxicity, the difficulties to access ART in some areas of the~     world, the fatigue expressed by patients about ART and the cost issues, there is an urgent~     need to search for HIV CURE. To date, only two cases of sterilizing HIV cure were reported~     so far: the famous Berlin Patient after two homozygous Delta32-CCR5 bone-marrow grafts for~     an acute leukemia [2], and the Mississipi baby after very early initiation of cART 31 hours~     after delivery [3]. However those cases of sterilizing HIV cure remain exceptional and the~     alternative objective of a functional HIV cure appears to be more realistic, though still~     described in rare groups of patients like Elite controllers (EC) and post treatment~     controllers (PTC) patients. In addition new and complex therapeutic strategies are currently~     proposed to try purging the HIV reservoirs, but none of them proved so far able to reach~     this goal.~      Therefore the objective of finding a Cure to HIV [4] requires first to better understand the~     basic mechanisms of the persistence of HIV reservoirs in the population of~     chronically-infected fully-suppressed HIV+ patients in order to define future therapeutic~     strategies.~   "
32754|NCT02628327|"~     1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department~          physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision~          related quality of life, and related issues.~        2. To collect and de-identify information from each participant's medical chart related to~          their care including information pertaining to demographics, disease severity, and~          prior and current treatment~        3. To assess the correlations between demographic factors, vision related quality of life,~          eye disease, and treatments with patient satisfaction survey responses.~   "
32755|NCT02628314|"~     The purpose of this research study is to test whether researchers can reliably measure the~     response pupils have when an acute painful stimulus is experienced. Changes in the size of~     the pupil of the eye can be an indicator of brain activity in a region of the brain that is~     important for feeling pain.~   "
32756|NCT02628301|"~     This study aims to elucidate the role of the microcirculation in the development of whole~     body insulin resistance. The investigators hypothesize that impaired insulin signaling in~     the vasculature is an early phenomenon in the development of whole body insulin resistance.~     Furthermore, the investigators aim to identify improvement of microvascular function as a~     potential target in diabetes prevention and treatment.~   "
32758|NCT02628275|"~     Subclinical atherosclerosis is identified in roughly 2/3rd of otherwise healthy young~     adults. How much physical activity is required to prevent progression of subclinical~     atherosclerosis? In the 85% of healthy younger Canadian men and women who do NOT perform the~     recommended 150 min/week of moderate- to vigorous-intensity physical activity (MVPA) as~     recommended, is it reasonable to aim for a lower regimen of light physical activity (LPA)~     despite the absence of supporting literature, or to the contrary should the investigators~     insist on achieving MVPA? In this perspective, MoMA provides a unique opportunity to~     determine whether LPA vs. MVPA is necessary to limit subclinical atherosclerosis progression~     in inactive otherwise healthy adults. Resolving such unknowns should inform strategies to~     prevent decades of silent disease progression leading to future morbidity and mortality.~   "
32759|NCT02628262|"~     Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the~     patients with macular hole. Investigators investigate the association between FAF and visual~     acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.~   "
32760|NCT02628249|"~     Protein requirements in individuals who participate in endurance-based exercise training~     have been suggested to be greater than the current recommended dietary allowance (RDA).~      The biological value of protein depends on the amino acid composition. As liebig's law of~     the minimum, the protein synthesis is limited due to the lack of single rate limiting amino~     acid. In this case, the first rate limiting amino acid determines protein intakes to~     maximize the protein synthesis. Adding a small amount of rate-limiting amino acid to the~     diet improves the biological value of its protein diet.~      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid~     requirement in children, normal healthy adult and clinical populations. however, the IAAO~     method has never been utilized for determining the first rate limiting amino acid.~      Therefore, the purpose of this study is to address of IAAO method to be applied for~     determining the rate-limiting amino acid in endurance athlete.~   "
32761|NCT02628236|"~     The purpose of this study is to evaluate the potential for systemic exposure of~     aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under~     occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)~     involving the upper extremities.~   "
32762|NCT02628223|"~     Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in~     treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and~     studies at academic centers have shown mixed results when comparing the success rates of 180~     degrees or 360 degrees. Both protocols are now typically done by comprehensive~     ophthalmologists. However, there is no data that compares success rates of 180 degrees and~     360 degrees in the community setting.~   "
32763|NCT02628210|"~     This is a single-arm post-market study in patients requiring lumbar fusion using allograft~     interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with~     degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10~     sites. After subjects have signed an informed consent, the baseline visit and examinations~     will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and~     24 month visit after surgery.~   "
32764|NCT02628197|"~     The purpose of this interventional study was to investigate the impact of control of~     systemic inflammation by scaling and root planing (SRP) on bone mineral density (BMD) in~     osteopenic post-menopausal women with Chronic periodontitis(CP). Out of 68 osteopenic~     postmenopausal women with CP, 34 participants each were included in test and control group.~     BMD, hsCRP and periodontal parameters were recorded at baseline and 6 months.~   "
32765|NCT02628184|"~     BACKGROUND: In 2011 a Maternity Services Development Programme was implemented in a South of~     England city, to promote effective collaborative working between maternity services~     (midwives) and other service providers (health visitors, social workers, specialist services~     etc.) by co-locating services in local childrens centres. The progamme ultimately aimed to~     improve care for local service users (women and their families), especially those considered~     vulnerable. Implemented changes were based on evidence that suggests poor collaborative~     working contributes to poorer outcomes. RATIONALE: To explore the impact of the programme on~     local service providers, and by association service user care. AIM: To explore a localised~     Maternity Services Development Programme, identifying how inter- agency collaborative~     working occurs, and the service providers perceived benefits and challenges on~     collaboration, and by association service user care. METHODOLOGY: The proposed research uses~     a case study approach to collect and analyse predominantly qualitative data, and some~     quantitative data. Data will be collected using observation episodes (e.g. participant~     meetings) to observe collaboration, and interviews to explore these experiences.~     Additionally documents will be analysed to observe documented evidence of collaborative~     practice. Pre-existing statistical data will also be used to highlight changes in indicators~     of service user well being since the implementation of the Maternity Services Development~     Programme. PARTICIPANTS: A cross-section of service providers (no service users) working in~     or with maternity services from 4 of 9 city Children Centre's. FINDINGS: No current~     findings, data collection expected to start September 2015.~   "
32766|NCT02628171|"~     This study evaluates the effect of cashew nut consumption on traditional and emerging~     markers of cardiovascular disease (CVD) risk and determines the usable energy content of a~     serving of cashew nuts for accurate food labelling.~   "
32767|NCT02628158|"~     Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal~     pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators~     evaluate whether presence of FAF may correlate to the postoperative visual outcome for~     epiretinal membrane.~   "
32768|NCT02628145|"~     This is a randomized clinical trial with a control group that will test how periodized~     resistance training will impact measures of sarcopenia in older women who have been~     identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks~     in duration with 24 total free-living older women. Outcome measures will be collected at~     baseline, 6 weeks and post-intervention.~   "
32842|NCT02627183|"~     The main purpose of this project is to determine the impact of atrial fibrillation~     interventions (catheter ablation and exercise training) on circulating BDNF concentrations~     in patients with atrial fibrillation. It also seeks to determine if there is a relation~     between circulating BDNF concentrations and mental health (depression severity, quality of~     life and symptoms) among those undergoing interventions for atrial fibrillation catheter~     ablation or exercise training.~   "
32769|NCT02628132|"~     The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al~     2006). In addition, PD-L1 has been shown to work as a molecular shield, by protecting~     cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008)~     suggesting to combine PD-L1 blockade with chemotherapy.~      This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative~     breast cancer patients. The safety profile of Durvalumab as a monotherapy has been~     previously established (lu et al 2015). In this trial the safety profile and tolerability of~     Durvalumab given in combination of Paclitaxel will be tested. In addition, the efficacy of~     this combination on metastatic breast cancer will be monitored.~   "
32770|NCT02628119|"~     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in~     significant clinical morbidity in patients with End Stage Renal Disease (ESRD), causing a~     severe economic burden on any health care system. Arteriovenous (A-V) dialysis accesses are~     the preferred form of permanent dialysis access as compared to central venous catheters~     (CVC) . One of the reasons for CVC use is poor long term patency rates of A-V access.~     Arteriovenous Grafts (AVG) have a primary patency rates of just under 50% at 12 months and~     around 33% at 18 months. Native arteriovenous fistula (AVF) are slightly better with primary~     patency rates of around 60 percent at one year and 51 percent at 2 years. The most common~     cause for AVF and AVG dysfunction is stenosis development due to neointimal hyperplasia~     (NIH) within the circuit leading to access thrombosis. Percutaneous transluminal angioplasty~     (PTA) is the current standard of treatment for these lesions. Despite being the treatment of~     choice for these lesions patency rates after PTA continue to be dismal. One of the problems~     with poor long term outcomes after successful intervention is how you assess immediate~     intervention success. Successful angioplasty is defined by Dialysis Outcome Quality~     Initiative (DOQI) guidelines as one where only less than 30% residual stenosis remains at~     the end of intervention. Unfortunately angiographic images post angioplasty correlate poorly~     with improvement of access flows through the arteriovenous circuit. There are two main~     problems with these practice standards. First, they are based on a 2-dimensional~     angiographic view of the lesion which may be misleading. Secondly, this assessment of recoil~     is very subjective and not base on objective data.~      Access flow monitoring can now be performed intra-procedurally with thermal dilution~     technique. Its benefit was shown in a small pilot study. To date there have not been any~     randomized controlled trials to assess the benefit of such an approach where intervention is~     based on improvements in access flow at the time of intervention. We hypothesize that such~     an approach will improve outcomes after interventions related to access dysfunction. This~     may also identify the right scenarios in which stent placement may benefit thus improving~     outcomes after stent placement as well.~   "
32771|NCT02628106|"~     The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on~     renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent~     magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were~     included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD~     without diabetes. In addition to the conventional treatments, all patients received 10 ug~     lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed~     before and after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and~     medullary R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1~     including 24 hours urinary protein and serum creatinine were collected. the investigators~     want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.~   "
32772|NCT02628093|"~     Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects~     undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the~     instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2~      - Ligasure Population~   "
32773|NCT02628080|"~     Solid tumours often have highly disorganised vasculature that results in low oxygenation.~     This combined with high metabolic rates leads to oxygen demand outstripping supply causing~     tumour hypoxia. Hypoxia drives multiple cellular processes involved in the hallmarks of~     cancer. Tumour hypoxia also decreases the effectiveness of anticancer treatments. This is~     especially true for patients treated with radiotherapy since it has been long recognised~     that hypoxic tumour cells require 3 times the dose of radiation to cause the same amount of~     cell death as cells irradiated under normal oxygen conditions.~      To date, the majority of attempts at overcoming tumour hypoxia have focused on increasing~     oxygen supply. However, such techniques have produced modest benefits at best and~     subsequently have not been adopted into current clinical practice.~      An interesting alternative approach to tackling tumour hypoxia is to decrease oxygen~     'demand' by reducing tumour oxygen consumption. This strategy has been suggested to be more~     effective in reducing hypoxia than previous methods aimed at increasing oxygen delivery.~      Pre-clinical data demonstrates that the commonly prescribed anti-protozoal drug atovaquone~     significantly reduces oxygen consumption in a variety of tumour cell lines in vitro. This~     reduction in oxygen consumption leads to a profound reduction in tumour hypoxia in animal~     models. It is anticipated that if these effects on tumour hypoxia could be reproduced in~     humans, that their tumours could be rendered markedly more sensitive to radiotherapy.~      This window of opportunity trial will assess whether atovaquone significantly reduces tumour~     hypoxia in adult patients referred for surgery with suspected non-small cell lung cancer.~     This will be assessed using a combination of functional imaging and circulating markers of~     hypoxia. If atovaquone is demonstrated to result in a reduction in tumour hypoxia, larger~     clinical trials will be conducted to determine whether this well-tolerated and inexpensive~     agent improves radiotherapy efficacy and clinical outcomes.~   "
32774|NCT02628067|"~     In this study, participants with multiple types of advanced (unresectable and/or metastatic)~     solid tumors that have progressed on standard of care therapy will be treated with~     pembrolizumab.~   "
32775|NCT02628054|"~     Research studies have found a relationship between the immune system (how the body reacts to~     an infection) and the development of depression. As it is still unclear how they might be~     linked the investigators will use a typhoid vaccination to activate the body's immune system~     and will measure the response by looking at changes in sleep patterns.~   "
32776|NCT02628041|"~     High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to~     Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as~     90-100% for favorable prostate cancer at a median follow-up of 3-5 years.~      HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup~     errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB~     causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can~     lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and~     Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and~     increased psychological distress.~      The goal of the investigators' phase II randomized study is to evaluate the differences in~     QOL in the urinary domain between patients with favourable intermediate risk or extensive~     low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate~     Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen~     since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB.~     Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate~     Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to~     assess local control.~   "
32777|NCT02628028|"~     The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in~     adults with rheumatoid arthritis (RA).~   "
32778|NCT02628015|"~     This study tests preschoolers, school children, youths and young adults, who were born~     preterm or full-term, in their theory of mind abilities.~   "
32779|NCT02628002|"~     This study will test the hypothesis that the anti-gravity treadmill can be safely used in~     stress nuclear myocardial perfusion imaging in patients unable to perform conventional~     treadmill exercise.~      This will be foundational evidence on which to consider a larger clinical trial to show that~     the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress~     testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT~     as well as having implications for cardiac PET and MRI in the future.~   "
32780|NCT02627989|"~     This study intends to investigate patient satisfaction of treatment with Ointment (W/O~     emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic~     dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction,~     treatment adherence, itchiness, and AD severity scores.~   "
32781|NCT02627976|"~     A common complication of breast conserving therapy is breast edema, which may lead to~     chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is~     present most patients are currently treated with physical therapy, but evidence of its~     effectiveness is still low and a gold standard does not yet exist. A downside of physical~     therapy is that patients have to undergo the therapy regularly and treatment might even has~     to continue for years after symptoms and treatment started. Another treatment option is a~     compression vest with the potential, apart from reducing symptoms, to improve self-efficacy~     in patients because they decide when to wear it without the need to visit therapists.~     However effectiveness of the compression vest has not yet been objectified in studies.~      The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of~     breast edema of wearing a compression vest, in order to determine whether a large randomized~     study is feasible.~   "
32782|NCT02627963|"~     This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center,~     parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced~     renal cell carcinoma (RCC).~      Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.~      Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database~     Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior~     vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior~     checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L)~     inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).~      All subjects will be evaluated for progression free survival, overall survival, objective~     response rate, and the duration of response as well as safety and tolerability.~      Pharmacokinetic (PK) analysis are also included in study.~   "
32783|NCT02627950|"~     The current prospective, randomized, controlled MonAMI trial aims to systematically examine~     the effects of morphine on the platelet inhibitory effects of the orally administered~     platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the~     potential positive or negative effects of MCP in combination with morphine on platelet~     inhibition will be studied.~   "
32784|NCT02627937|"~     The purpose of this study is to develop adequate and satisfactory tools using reliable~     clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea~     syndrome (OSAHS) and allow greater access to appropriate therapy in children.~   "
32785|NCT02627924|"~     The study is designed as a prospective, observational study to assess the effect of~     adalimumab on health-related quality of life (QoL) and work productivity in patients with~     rheumatoid arthritis (RA) in Korea~   "
32786|NCT02627911|"~     The study will be conducted in crossover trial, with two 72-hour hospitalization separated~     by a period Wash-out of at least one week. Each hospitalization is a period of treatment.~     According to randomization, patients will be provided with either Diabeloop system or the~     usual system.~      In both treatment periods:~        -  patients in a situation of sedentarity or physical activity, will be equipped with~          ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)~        -  meals and physical activities will be similar in both periods~        -  the same blood glucose meter will be used throughout the duration of the study.~        -  the capillary blood glucose will be performed : before bolus and 2 hours after a meal,~          before exercise, in case of hypo or hyper-glycemic episodes and when the patient and /~          or investigator deem it necessary.~   "
32787|NCT02627898|"~     Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic~     disease is also highly prevalent and primarily associated with an increased cardiovascular~     mortality and morbidity due to micro and macrovascular complications, where its~     pathophysiological mechanism accelerates the formation of the atherosclerotic process,~     fundamental element associated with arterial stiffness. The importance of anticipating the~     presence of a cardiovascular event lies precisely in the early detection of subclinical~     changes in the elastic arteries identified by measuring the pulse wave velocity. Having~     adequate pharmacological or non-pharmacological interventions that impact precisely in the~     reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and~     mortality associated with DM2. Among non-pharmacological therapies they have been studied~     the benefits attributed to the use of green tea infusion either encapsulated or extract have~     been associated mainly with anti-inflammatory and antioxidant effects. There are both~     experimental and clinical studies that have shown benefits of administration of green tea~     (extract or infusion), and administered by different routes at different dosages and for~     varying times. But it has been noted that not all studies with green tea meet appropriate to~     draw conclusions about its benefits to cardiovascular level. However, it is proposed that~     the use of green tea extract with a highest amount of catechins through a controlled~     clinical trial could be a potential therapeutic strategy for changing hemodynamic~     alterations and arterial stiffness favorably in this particular group of patients DM2.~   "
32788|NCT02627885|"~     The aim of the study is to investigate if an Internet-based psychological treatment based on~     principles from Cognitive Behavioral Therapy can increase function and quality of life for~     patients with Parkinson disease.~   "
32789|NCT02627872|"~     Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which~     primarily increases among the female population. The purpose of this study is to perform~     in-depth clinical and molecular characterizations of early stage COPD patients, as well as~     healthy never-smoker and at-risk smoking control populations to identify molecularly related~     subgroups patients, including gender-related sub-phenotypes of COPD.~   "
32790|NCT02627859|"~     26 week open label study of treatment with Durolane for OA pain of the ankle~   "
32793|NCT02627820|"~     ATTRwt (also known as senile systemic, or senile cardiac amyloidosis) is a progressive heart~     disease, causing congestive heart failure. It is caused by amyloid protein deposits in the~     heart, that are derived from a normal protein, TTR, made in the liver. The aim of the study~     is to determine whether lowering the blood levels of TTR, by a weekly injection of a~     compound designed specifically to do this, will slow the progression of the disease when~     treated patients are compared to previously-followed patients who were not receiving this~     drug. The study also aims to determine how well this drug is tolerated and the existence and~     severity of any drug side-effects.~   "
32794|NCT02627807|"~     The purpose of this study is to compare individualized clinical target volume (CTV) based on~     disease extension risk atlas and computer-aided delineation with traditional CTV in~     intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to~     confirm the efficacy and safety.~   "
32795|NCT02627794|"~     Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic~     rhinosinusitis that is not adequately controlled with maximal medical therapy.~      In some patients, underlying inflammation (discharge, edema and polyposis), compounded by~     inflammation caused by surgical trauma may lead to an uncontrolled healing response, which~     results in the synechiae formation in the middle meatus (MM).~      Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of~     middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic~     visualization of the sinus cavities postoperatively. This may result in difficulty in~     performing postoperative routine endoscopic debridement and examination, which is paramount~     to a successful outcome from ESS. Spacers are often inserted during surgery between nasal~     mucosal surfaces to prevent synechiae.~      The aim of this study is to see if a steroid-impregnated spacer is more effective at~     reducing inflammation after sinus surgery than a Silastic spacer.~   "
32796|NCT02627781|"~     The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high~     incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to~     negative appendectomies. The aim of the present observation study is to evaluate a~     diagnostic and therapeutic algorithm for suspected acute appendicitis.~      The investigators believe that this diagnostic algorithm helps to simultaneously avoid~     unnecessary operations, costs and radiation exposure.~   "
32797|NCT02627768|"~     The purpose of this study is to evaluate treatment retention in psoriatic arthritis~     participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in~     relation to effectiveness, safety, benefit/risk and to examine clinical response.~   "
32798|NCT02627755|"~     The use in a combined way of two systems of intubation (Glidescope + aScope) would condition~     an increase in the success rate of endotracheal intubation maneuver compared to conventional~     isolated Glidescope use in patients with clinical criteria of difficult airway.~   "
32799|NCT02627742|"~     To determine if a therapy regimen including treatment with The MetaNeb® System has a~     positive impact on the rate of pulmonary complications that occur in high risk~     post-operative patients. This is a non-randomized facility (or hospital) level pre-post~     intervention study.~   "
32800|NCT02627729|"~     Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal~     cancer patients treated with laparoscopic hand-assisted low anterior resection~   "
32801|NCT02627716|"~     The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance~     directive which involves the patient, the healthcare team, their relatives and a third party~     caregiver as intermediary for the project.~      The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the~     reduction in hospitalisations within 18 months of its development by comparison to the~     standard psychiatric care.~      Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months~     and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.~      Single blind multicentre randomised trial with parallel control groups.~      Effectiveness study of a psychiatric care strategy.~   "
32802|NCT02627703|"~     This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay~     on the decision making of the treating physician and the patient. The Oncotype DX® assay is~     a commercially available diagnostic test that aids in a physician's treatment recommendation~     to a breast cancer patient. The study also has a pharmacoeconomic component.~   "
32803|NCT02627690|"~     Islet transplantation for type 1 diabetes results are still improving, and actually~     Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of~     c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological~     interventions to inject islets, an immunosuppressive regimen is needed, which can be~     deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet~     transplantation on stabilization or prevention of macro and micro vascular complications of~     diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or~     improvement of microvascular complications when compared to pre-transplant datas.~      The aim of this study is to compare the evolution of diabetes complications, especially~     nephrologic, 10 years after islet transplantation and to compare it to patients with a~     brittle diabetes, 10 years after evaluation for islet transplantation, finally not~     performed.~      This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine~     clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications~     of type 1 diabetes) before islet transplantation and 10 years after the transplantation or~     after the first evaluation in patients who finally did not underwent islet transplantation~     for various non nephrologic reasons~   "
32804|NCT02627677|"~     The purpose of this study is to compare the efficacy and safety of 2 starting doses of~     ponatinib compared to nilotinib in patients with imatinib-resistant chronic myeloid leukemia~     (CML) in chronic phase (CP).~   "
32805|NCT02627664|"~     The investigators prospectively enrolled 64 early PD patients (less than 3 years after the~     first symptom) in order to prospectively assess the natural history of non-dopaminergic~     symptoms.~   "
32853|NCT02627040|"~     The main goal of the study is to determine which cephalomedullary nail results in a better~     functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects~     will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan~     cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.~   "
32806|NCT02627651|"~     18 children post acquired brain injury and 18 typically developed controls matched for age~     and gender.~      All children aged 10-18 yrs who understand simple commands.~      Tools:~        1. Heart rate monitor~        2. Six minute walk test~        3. The behavior rating inventory~      Method:~        1. At the introductory visit the child will be asked to walk for six minutes, to sit and~          perform a cognitive test and then to walk on a treadmill for 5 seconds.~        2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at~          the same time to perform the cognitive assignment; After a rest the child will be asked~          to walk on the treadmill for 5 minutes and at the end to perform the cognitive~          assignment .~   "
32807|NCT02627638|"~     For more than seven years an osteopath has been working in the palliative care unit (PCU)~     and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team.~     The patients referred to the osteopath by the palliative care physicians present pains~     related to cancer, but also to the treatment, in particular to surgery or radiotherapy. The~     osteopath can help with other symptoms such as constipation or dyspnoea. As this approach is~     provided in complement of the medicinal approach, it is not considered as an alternative~     medicine but as a complementary medicine associated to a conventional care. It seemed~     relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for~     pain how they saw this complementary therapy.~   "
32808|NCT02627625|"~     The purpose of this study is to compare the absorption of three different inhalation~     products with the reference products in healthy volunteers.~   "
32809|NCT02627612|"~     Some Veterans who recently served in the military report significant psychological problems~     based on their experiences in the military. Stressors that these Veterans face when they~     transition out of the military can acerbate these problems and negatively impact their~     long-term physical and psychological well-being. The investigators are conducting a~     randomized controlled trial to evaluate the efficacy of providing Veterans who are~     transitioning back into their civilian communities trained, peer mentorship (Pro Vetus) and~     membership in a Veteran Support Organization (VSO) Team Red, White, and Blue (TM RWB) to~     reduce transition stressors, maintain psychological and physical health, reduce suicides and~     reduce criminal incidents.~   "
32810|NCT02627599|"~     -  Evaluate subjects in an prospective observational study~        -  Subjects will be administered scientifically validated questionnaires~        -  Evaluate Quality Improvement and Oxygen Utilization Improvements.~           1. Functional capability, dyspnea, oxygen saturation as primary endpoints~             1. Baseline Dyspnea Index (BDI)~             2. Transitional Dyspnea Index (TDI)~             3. Chronic Respiratory Disease Questionnaire (CRQ)~             4. Six minute walk distance (6MWD)~             5. Oxygen saturation using pulse oximeter~        -  The secondary endpoints:~             1. Portable oxygen source utilization~             2. Health care utilization (emergency room encounters, hospital admissions)~   "
32811|NCT02627586|"~     Several studies have shown that high-intensity interval training (HIIT) is more effective~     than moderate-intensity continuous exercise training (MICE) at improving functional capacity~     and quality of life in stable cardiac patients and can be performed safely.~      However, its effect on patients after recent myocardial infarction is currently unknown. In~     these patients avoidance of a negative remodeling after an acute myocardial infarction is of~     upmost importance. Therefore, assessment of the influence of HIIT on post-infarct left~     ventricular-remodeling is urgently needed.~      Therefore, the aim of this study is to determine the effect of HIIT on left ventricular (LV)~     remodeling (measured by LV end diastolic volume) compared to the effect of the more~     established MICE training modality.~      Further measurements include other parameters of LV remodeling (LV contractility, and brain~     natriuretic peptide), prognostic parameters (peak oxygen uptake, exercise capacity), cardiac~     output, endothelial function, leg muscle function and scores of quality of life. Further,~     certain blood parameters and heart rate variability measured by electro-cardiogram are~     measured to assess the safety of this type of training.~      Patients with first ST-segment elevation myocardial infarction (STEMI) or equivalent with~     onset of symptoms of ischemia and treated by primary percutaneous intervention within the~     preceding 4 weeks will be included.~      The HIIT and MICE is integrated in a 12-week exercise training program at the Inselspital~     Bern, consisting of 1) exercise training, 2) nutrition counselling and 3) psychotherapy. The~     exercise program will comprise 3 weekly exercise sessions lasting 90 minutes, supervised by~     experienced exercise therapists. The program focuses on endurance type exercises,~     strengthening and relaxation exercises as well as exercises to improve coordination skills.~     In the first 3 weeks (run-in-phase), all patients will complete three weekly MICE sessions.~     In the following 9 weeks, patients randomized to the intervention group will perform two~     weekly HIIT sessions and one MICE session per week. The control group will continue with~     three weekly MICE sessions for the 9 week intervention phase.~      A total of 144 patients will be recruited. Measurements will be performed at baseline, after~     a 3-week run-in-phase, and after the 9-week intervention phase. Safety measurements will be~     performed during the 4th and 12th week.~   "
32812|NCT02627573|"~     Purpose There is a growing evidence of high efficacy of post-transplantation~     cyclophocphomide (PTCy)-based GVHD prophylaxis in haploidentical and matched related and~     unrelated bone marrow transplantation. There is limitted, but growing data on safety and~     efficacy of this prophylaxis in unrelated and peripheral blood stem cell transplantations.~     Use of PTCy in chronic myeloproliferative neoplasms and myelodisplatic syndrome is of~     particular interest. On the one hand, PTCy could reduce the incidence of chronic GVHD and~     long-term bormidity. On the other hand, there is a concern, that PTCy can increase the~     incidence of graft failures in this group of patients. Currently published data indicate~     that low-dose Thymoglobulin-based prophylaxis is the most promissing compatitor in terms of~     acute and chronic GVHD control. So there is a rationale to randomize Thymoglobulin and PTCy~     as GVHD prophilaxis. Pre-transplant assesment of moratlity (PAM)-index will be used as the~     strata for randomization, as it is the paramter that takes into account the most important~     factors effecting survival. The conditioning regimen and the other two components of GVHD~     prophylaxis (mycophenolate mofetil and tacrolimus) will be identical in the two arms of the~     study.~   "
32813|NCT02627560|"~     After surgical procedures, interventions to reduce postoperative bleeding are of great~     importance. In this study, the effect will be investigated of smearing tranexamic acid,~     which is designed for injection, directly onto the raw wound surface (topical application)~     created during surgery. Topical application allows a small amount of drug to reach a large~     wound area, higher drug concentration in the exposed wound surface but very low~     concentration in the body, and no risk of injury from needles. The researchers have recently~     shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided~     breast reduction surgery. Now it will be studied whether topically applicated tranexamic~     acid reduces bleeding after breast surgery for breast cancer.~      After surgery for breast cancer patients may also experience problems with long lasting~     seroma. Therefore it will at the same time be investigated whether topical tranexamic acid~     reduces the development of seroma in these patients.~   "
32854|NCT02627027|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.~   "
32814|NCT02627547|"~     Flavonoids are compounds that have been proven to have a beneficial effect on health, such~     as reducing the risk of developing cardiovascular disease and, in some cases, cancer. Citrus~     juices have a high flavonoid content. However, the absorption of flavonoids into the body is~     limited. This study will investigate whether being physically active improves the absorption~     of flavonoids.~      Endurance trained athletes will be invited to participate. Following screening procedures~     (a. Health Screening Questionnaire; b. height and weight measurement for calculation of Body~     Mass Index; c. maximal oxygen consumption (VO2max) uptake test, eligible participants will~     undertake two experimental tests; one during a period of normal training, the other~     immediately following 1 week of detraining.~      In the morning of the experimental trial participants will consume 500 mL of orange juice.~     Blood samples and urinary fractions will be collected prior (base line) to and for 24 hours~     after orange juice consumption. Participants will be asked to follow a special~     polyphenol-free diet and record weighed dietary intake for 2 days preceding each trial and~     during the day of the experimental trial.~      The study aims to:~        1. Determine the effects of training status of endurance athletes on bioavailability of~          flavanones in endurance trained individuals~        2. Determine whether changes in bioavailability of flavanones are related to changes in~          biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.~   "
32815|NCT02627534|"~     Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This~     close relationship between both diseases is characterized by mutual influence. The presence~     of DM might impair prognosis of diverse dental treatments due to its inflammatory nature,~     negative influence on wound healing, on bone biology, and the establishment of infections.~     Consequently, knowledge of new dental therapies and the biology of dental treatments for~     chronic periodontitis in diabetic patients can enhance quality of life and make these~     treatments more adequate for this common profile of patients.~   "
32816|NCT02627521|"~     The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients~     presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct~     to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at~     an early time point includes non ST elevation myocardial (NSTEMI) patients and those~     undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is~     estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease~     requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay~     of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced~     platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose~     these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to~     wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be~     unnecessary due to the significant inter individual variability in response to Ticagrelor.~     There is limited data to determine the optimum timing of CABG surgery in ACS patients~     treated with Ticagrelor. The present study will determine the optimum timing of CABG in ACS~     patients treated with a loading and/or maintenance dose of Ticagrelor.~   "
32817|NCT02627508|"~     This is a research study to examine the tolerability and effectiveness of pregnenolone in~     individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain~     that has been implicated in treating various psychiatric conditions. The investigators hope~     to learn the effects and safety of using pregnenolone in reducing irritability and~     sensitivity to sensory differences and improving social communication in individuals with~     autism. The investigators hope by studying the effects of pregnenolone in more detail, the~     investigators can design better ways to treat individuals with autism.~   "
32818|NCT02627495|"~     This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on~     Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study~     design.~   "
32819|NCT02627482|"~     Most babies who measure small during pregnancy are born healthy. However, some are small~     because they are not growing as expected, usually because the placenta (the baby's 'life~     support' system) is not working properly. These babies are at greatly increased risk of~     dying before birth, and need to be delivered before they become poorly.~      Scans and electronic heartrate monitoring are currently used to monitor these babies. But~     they can only be used for short periods and don't always provide enough information to show~     when to deliver the baby.~      A small light monitor has been developed that safely records the baby's heart rate for up to~     16hrs by measuring electrical activity through sticky patches on the mum's skin (like a~     normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the~     heart rate over a longer time may help with decisions about the timing of the delivery and~     could prevent stillbirth, the aim of our future study. This will include large numbers of~     women carrying small babies. Before the investigators can do this the investigators need to~     know whether:~        1. Wearing the monitor for 16hrs is practical and acceptable to pregnant women~        2. The monitor can provide useful information on the baby's heart rate at different stages~          of pregnancy.~      Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on~     two occasions, for 16hrs each time. The women will describe what they think about wearing~     the monitor by completing questionnaires.~      The data from the monitor will be downloaded and compared with the woman's medical notes~     after the participant has delivered her baby. Results from this study will be publicised and~     will help with the design of the investigators future study into the usefulness of this~     monitor.~   "
32820|NCT02627469|"~     Objective: The effect of weekly professional oral care on the composition of the oral flora~     in dentate, dependent elderly residents was followed during a 12-month period.~      Background: Long-term, regular professional oral hygiene care reduces the total number of~     microorganisms and oral disease-related microorganisms. Less is known about the effect on~     the quality/composition of the remaining oral flora.~      Materials and methods: Thirty-three subjects were included in the study group and 35 in the~     control group. Dental status, presence of supragingival-plaque, labial minor gland secretion~     rate, and prescription medicines were recorded. Microbial samples, collected from~     supragingival plaque and the dorsum of the tongue, were analyzed using cultivation~     technique.~   "
32855|NCT02627014|"~     The aim of this study is to determine whether treatment of temporomandibular joint is more~     effective than usual care in patients with chronic migraine and temporomandibular disorders~     to reduce pain.~   "
32821|NCT02627456|"~     Background:~      Malaria is still a health problem in Sub-Saharan Africa. Death rates are stable and have~     even increased in some areas. There are malaria vaccines. However, researchers think~     repeated immunizations with a vaccine called PfSPZ may work better.~      Objective:~      To see if PfSPZ is safe, tolerable, and effective against malaria.~      Eligibility:~      Healthy adults ages 18 to 50 years who live in the Doneguebougou area in Mali~      Design:~      Participants will be screened with medical history and physical exam.~      Participants will sign or fingerprint the consent form. They will take a survey to see how~     well they understand the study.~      Participants will give blood and urine samples.~      Participants will have at least one ECG: Soft electrodes will be stuck to the skin. A~     machine will record heart signals.~      Participants will have HIV counseling.~      Participants will be assigned to a group. Groups will get a different strength doses. Groups~     will get a different number of vaccines over different periods of time.~      If a participant develops a rash or injection site reaction, photographs may be taken.~      Participants will receive an oral anti-malaria drug during the study.~      Participants will be monitored for 3 to 6 months after the last vaccine.~   "
32822|NCT02627443|"~     This randomized phase II trial studies the side effects and how well carboplatin and~     gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 work in treating~     patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back~     (recurrent) and has spread to other places in the body (metastatic). Drugs used in~     chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and~     gemcitabine with or without ATR kinase inhibitor VX-970 may work better in treating ovarian,~     primary peritoneal, or fallopian tube cancer.~   "
32823|NCT02627430|"~     This phase I trial studies the side effects and best dose of talazoparib and heat shock~     protein (HSP)90 inhibitor AT13387 when given together in treating patients with solid tumors~     that have spread to other places in the body (metastatic) or ovarian, fallopian tube,~     primary peritoneal, or hormone negative breast cancer that have come back after a period of~     improvement (recurrent). Talazoparib and HSp90 inhibitor AT13387 may stop the growth of~     tumor cells by blocking some enzymes that are need for cell growth. HSp90 inhibitor AT1338~     may also help talazoparib work better by making tumor cells more sensitive to the drug.~   "
32824|NCT02627417|"~     Due to its expected efficacy based on the retrospective data available in ITP, its~     relatively good safety profile and its very low cost , dapsone could be a good~     steroid-sparing second-line option for adults with ITP.~      This study is a phase III prospective multicenter randomized open trial comparing two~     treatment strategies:~        -  Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day~          up to week 52 if an initial response is achieved.~        -  Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and~          standard of care The aim of the study is to demonstrate the efficacy of dapsone based~          on the overall response rate (including response and complete response) as a~          second-line treatment for adults with newly-diagnosed or persistent ITP not achieving a~          durable response with corticosteroids. The primary endpoint will be the overall~          response-rate (response or complete response according to standard definitions) in both~          arms at week 52 (1 year).~      The secondary endpoints are the following :~        -  To assess the safety of dapsone over the study period and especially the incidence of~          cutaneous reactions.~        -  To analyze the overall response rate (platelet count > 30 x 109/L with at least a~          doubling of the pre-treatment count in the absence of any other ITP treatment) in both~          treatment arms at week 24.~        -  To compare the rate of complete response and failure in both arms at 24 and 52 weeks.~        -  To compare time to treatment failure (TTF) in both arms~        -  To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients~          (ancillary study)~   "
32825|NCT02627404|"~     Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic~     vulnerability factors. To help the identification of these genetic factors and to improve~     genotype-phenotype correlation, the identification of endophenotype through the exploration~     of vulnerability characteristics in unaffected first degree relatives have been recommended.~     For this purpose, the investigator include bipolar patients, unaffected first degree~     relatives and control subjects to perform genetic association studies and subphenotype~     analyses. In this study the investigator will focus on subgroups defined according to the~     existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).~      Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is~     highly variable and difficult to predict due to lack of biomarkers of response. To explore~     lithium response variability and to identify biomarkers of response, the investigator~     characterise lithium response using ALDA scale to conduct pharmacogenetic studies and~     pharmacokinetic studies of lithium extended release, in the subpopulation of patients~     treated with lithium. As lithium is a circadian agent, the investigator will also explore~     the links between lithium response and circadian phenotypes. Finally, using Li7 magnetic~     spectroscopy, the investigator will compare lithium brain distribution in a small sample of~     good and partial responders to lithium.~   "
32826|NCT02627391|"~     Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS)~     saves lives. However there is currently no direct evidence for this and most recommendations~     from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence.~     Therefore, the investigators designed a randomized controlled trial to demonstrate whether~     early surgery improves mortality and morbidity of patients with asymptomatic severe AS and~     low operative risk.~   "
32856|NCT02627001|"~     This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral~     Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat~     medics.~   "
32857|NCT02626988|"~     What is the role of Agricultural biodiversity in improving diet diversity, quality and~     nutrition?~   "
32858|NCT02626975|"~     MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament~     (ACL) according to DT4 technique in 60 patients with more than one year of follow up.~   "
46638|NCT02446561|"~     To determine whether three new oral formulations of a strong pain killer release the drug~     into the body in a similar pattern as the already marketed reference capsule formulation~     with or without food~   "
32827|NCT02627378|"~     A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in~     2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is~     associated with high mortality rate in approximately 36% of reported patients.~      The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide~     infections, including at least 490 related deaths, from September, 2012, to July 24, 2015.2~     The higher incidence of MERS-CoV infections in Saudi Arabia may be related to multiple~     factors, including seasonality, increased proactive screening, poor infection control~     measures, low relative humidity, and high temperature.~      Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging~     from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to~     respiratory failure, in approximately 2/3 of infected patients, which has a high mortality~     rate, particularly in immunocompromised patients.~      Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with~     refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides~     respiratory support for patients with respiratory failure, whereas the use of veno-arterial~     (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival~     rate of the infected patients with H1N1 who required the use of ECMO varies considerably~     among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35%~     in Japan). This large discrepancy could be explained with lack of satisfactory equipment,~     therapeutic guidelines, training of staff, and effective systems allowing patient transfer~     to the dedicated ECMO centres.~      Guery and co-investigators described the use of ECMO in two French patients with~     cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for~     treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.~   "
32828|NCT02627365|"~     The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive~     SMS intervention to optimize individual health and secondary HIV prevention benefits of ART~     in HIV-positive FSWs.~   "
32829|NCT02627352|"~     The purpose of this study is to investigate the surgical outcomes of the micropulse~     transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze~     intraocular pressure lowering effect; and correlate related treatment parameters pending~     enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.~   "
32830|NCT02627339|"~     The purpose of this study is to build a database of results from a new test that measures~     contrast sensitivity (the Spaeth-Richman Contrast Sensitivity Test (SPARCS)). Contrast~     sensitivity is an important part of your ability to see. When contrast sensitivity~     decreases, you are less able to see objects and detect motion. For instance, if you have~     decreased contrast sensitivity, you might be less able to read, see in the dark, drive, hit~     a ball, or walk safely. Decrease in contrast sensitivity leads to a decrease in quality of~     life.~   "
32831|NCT02627326|"~     The aim of this prospective randomized controlled clinical trial is to evaluate the~     effectiveness of chlorhexidine intracanal medicament along with periodontal treatment in~     concomitant endodontic periodontal lesions with communication in terms of periodontal~     healing. Forty-seven patients were randomly divided into: group 1: conventional endodontic~     treatment with open flap debridement (OFD after 3 month of endodontic treatment) were~     performed, in group 2: endodontic treatment with 2% chlorhexidine gel (CHX) as an intracanal~     medicament placed in root canals and after 3 month OFD were performed. Primary outcome~     variables included probing pocket depth, clinical attachment level and bleeding on probing.~   "
32832|NCT02627313|"~     Conventional breast radiotherapy is delivered to the entirety of the breast in fractionated~     treatments given over several weeks. While these techniques are effective, there is a risk~     of late adverse events from irradiation of surrounding normal tissues and the protracted~     nature of the treatments is inconvenient to patients and resource-intensive for health care~     systems. There is an unmet need for novel treatments that can be delivered more quickly,~     with reduced normal tissue exposure, and without compromising efficacy. The GammaPod is a~     breast-specific radiotherapy delivery device that holds the promise in addressing these~     needs. Employing the engineering and physics principles from stereotactic radiotherapy, it~     allows delivery of a highly-localized radiation dose to a very limited volume of breast. The~     Ottawa Hospital is the only Canadian member of a consortium of five academic institutions~     that have acquired the GammaPod in order to rigorously evaluate its use in clinical trials.~     The aim of the current project is to complete a mandatory clinical feasibility study of the~     GammaPod as part of the application for Investigational Testing of Medical Devices from~     Health Canada. The study will focus on the use of the GammaPod to deliver a radiotherapy~     boost, that is, a localized dose of radiation just around the surgical bed, in a single~     treatment.~   "
32833|NCT02627300|"~     Patients will be followed from the time of completion of the SCGAM 01 trial until octanorm~     becomes commercially available in the USA, until the sponsor decides to terminate the trial,~     or until a patient's treatment duration of 2 years is reached (whichever occurs first).~   "
32834|NCT02627287|"~     This trial is conducted in Europe. The aim of this trial is to compare Injections with the~     Medical Device DV3316 Pen-injector versus FlexPen®.~   "
32835|NCT02627274|"~     This open-label, multicenter, dose-escalation study will evaluate the safety,~     pharmacokinetics and therapeutic activity of RO6874281 in participants with advanced and/or~     metastatic solid tumors. Participants will be treated until disease progression or~     unacceptable toxicity occurs, for up to a maximum of 24 months.~   "
32836|NCT02627261|"~     Three methods including flow cytometry, next generation sequencing and determination of~     circulating tumor cells will be performed at different time points in patients with~     previously undiagnosed multiple myeloma in order to determine the most sensitive method to~     detect residual disease~   "
32837|NCT02627248|"~     RATIONALE:~      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely~     used in China for many years. The investigators have found that Huaier could exert~     synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer~     cells. It is not yet known whether combination chemotherapy is more effective when given~     together with Huaier in the neoadjuvant setting .~      PURPOSE:~      To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast~     cancers with synergistic action of the neoadjuvant chemotherapy.~   "
32838|NCT02627235|"~     This pilot study represents an initial foray into delivering an Individual Voice~     Response-based (IVR) physical activity intervention for cancer risk among sedentary adults~     in the Deep South.~   "
32839|NCT02627222|"~     The study comprises an open-label randomized controlled trial investigating the efficacy of~     consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of~     Nigerian children, aged 3-4 years old (n=200).~   "
32840|NCT02627209|"~     This study evaluates the significance of differences in serum angiotensin converting enzyme~     and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and~     infectious diseases.~   "
32843|NCT02627170|"~     The human cornea is affected by the magnitude and velocity of both internal and external~     forces because the cornea has both static and dynamic resistance components. Considering~     these natures of the human cornea, many investigators have tried to demonstrate corneal~     biomechanical properties to understand these characteristics of the cornea. Corneal~     biomechanical properties are known to influence the accuracy of measurements in intraocular~     pressure (IOP) and are recognized as important factor to explain the susceptibility of~     development of glaucomatous damage. Until recently, the only instrument which enabled the in~     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,~     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the~     biomechanical properties of the cornea according to the dynamic bidirectional applanation~     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology~     [Corvis ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful~     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer~     captures the dynamic process of corneal deformation caused by an air puff using an~     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,~     well-organized analysis on the normative data of the corneal biomechanical profiles measured~     with the dynamic Scheimpflug analyzer has not been reported yet. Hence, in the present~     study, we aim to conduct normative data analysis for the corneal biomechanical properties~     with the dynamic Scheimpflug analyzer in South Korea.~   "
32844|NCT02627157|"~     The human cornea is affected by the magnitude and velocity of both internal and external~     forces because the cornea has both static and dynamic resistance components. Considering~     these natures of the human cornea, many investigators have tried to demonstrate corneal~     biomechanical properties to understand these characteristics of the cornea. Corneal~     biomechanical properties are known to influence the accuracy of measurements in intraocular~     pressure (IOP) and are recognized as important factor to explain the susceptibility of~     development of glaucomatous damage. Until recently, the only instrument which enabled the in~     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,~     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the~     biomechanical properties of the cornea according to the dynamic bidirectional applanation~     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology~     [Corvis ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful~     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer~     captures the dynamic process of corneal deformation caused by an air puff using an~     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,~     well-organized analysis on the normative data of the corneal biomechanical profiles measured~     with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet.~     Hence, in the present study, we aim to conduct normative data analysis for the corneal~     biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy~     adults in South Korea.~   "
32845|NCT02627144|"~     This is a non-interventional, multicenter study to evaluate efficacy and safety of~     intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for~     first-line treatment in participants with advanced and/or metastatic renal cell cancer~     (mRCC) in daily routine.~   "
32846|NCT02627131|"~     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in the management of autism.~   "
32847|NCT02627118|"~     The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical~     changes that occur when dialysis patients are treated with dialyzers known to leach BPA~     (Bisphenol-A) into the blood, such as the commercially available Fresenius F160NR, as~     compared with the same chemical evaluations in patients being treated with the non BPA~     containing ELISIO-15H dialyzer. Evaluations of patient's chemistries will be obtained prior~     to and after 2 months of standard dialysis treatments with each dialyzer.~   "
32848|NCT02627105|"~     This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight~     loss program.~   "
32849|NCT02627092|"~     The purpose of this study is to assess the impact of copper linens on hospital acquired~     infections and drug resistant bacteria.~   "
32850|NCT02627079|"~     The proposed pilot study will develop and test feasibility and preliminary efficacy of an~     exercise motivation intervention using a 12-week smartphone-text messaging program tailored~     to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors~     and 15 patients actively undergoing cancer treatment.~   "
32851|NCT02627066|"~     This is a 12 month randomized clinical trial in which patients with renal failure undergoing~     maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that~     includes a novel low sodium dietary education program mediated by a lifestyle~     interventionist with significant collaboration from the existing clinic staff. Participating~     patients will be randomized to receive: 1) the volume control protocol alone (VC), or 2) the~     volume control protocol + physical activity and exercise counseling (VCE) from the lifestyle~     interventionist (LI). A research dietitian (RD), working in collaboration with the existing~     clinic RD, will develop a program to immerse clinics in a culture of sodium restriction. The~     research RD will train the LI and other clinic staff (nurses, technicians, etc) to help~     disseminate this program, modeled after the clinic-wide dissemination approach used in~     Izmir, Turkey (Dr. Ercan Ok). In addition, the LI will provide exercise and physical~     activity counseling to the participants randomized to the exercise group, utilizing a~     SCT-based approach. The Investigators hypothesize that mean arterial pressure will be~     reduced, and physical function increased, in all patients at 12 months, but the magnitude of~     these improvements will be greater in the VCE group.~   "
32852|NCT02627053|"~     Anticoagulant therapy is generally recommended for all patients presenting with acute~     symptomatic splanchnic vein thrombosis, starting with either low-molecular weight heparin~     (LMWH) or unfractionated heparin and continuing with the vitamin K antagonists in most~     patients. Rivaroxaban is approved for the treatment of deep vein thrombosis and pulmonary~     embolism, but no studies have assessed the safety of rivaroxaban in the setting of~     splanchnic vein thrombosis. The investigators aim to collect prospective information on the~     safety of rivaroxaban in a pilot cohort of 100 patients with acute splanchnic vein~     thrombosis without liver cirrhosis.~   "
32859|NCT02626962|"~     This is a Phase 2, single-arm study of nivolumab combined with ipilimumab in subjects with~     previously untreated, unresectable or metastatic uveal melanoma. Previous studies with~     immunotherapy have shown promising results and this synergistic combination was very~     effective in other tumors. This study will allow for further characterization of the safety~     and clinical activity of nivolumab combined with ipilimumab in subjects with uveal melanoma.~   "
32860|NCT02626949|"~     By 2015 half of the people living with HIV infection in the U.S. are estimated be over the~     age of 50, and this cohort of patients with well-controlled plasma viremia is aging at a~     more rapid pace than their non-HIV peers. Long-term chronic inflammation plays a critical~     role in premature aging in HIV-infected adults. Markers associated with chronic~     inflammation, including IL-6, CRP, sCD14 and d-dimer, have not only been shown to be present~     at higher levels in HIV-infected adults, but are also correlated to a wide variety of~     morbidities and mortality. The goal of this project is to determine the impact of two~     different interventions -- Mindfulness-Based Stress Reduction (MBSR) and Health Enhancement~     Program (HEP) -- on reducing biological markers associated with chronic inflammation in~     HIV-infected adults with an undetectable HIV viral load. In order to achieve this goal, a~     pilot RCT with 120 subjects over 50 years old who are on anti-retroviral therapy (ART) will~     be conducted with the following specific aims: 1) to assess the effect of MBSR and/or HEP on~     biomarkers of chronic inflammation (IL-6, CRP, sCD14, d-dimer), and, 2) to explore whether~     changes in psychological well-being (anxiety, depression, fatigue, cognitive functioning)~     mediate the impact on chronic inflammation. Subjects will be randomized to participation in~     a group MBSR course or to the HEP group both of which consist of 8 weekly sessions followed~     by 6 monthly booster sessions. Three time points will be measured: baseline, 8 weeks~     (immediately after completion of weekly intervention), and 6-months post-completion of~     weekly intervention. Mixed linear and structural equation model will be used to test the~     study hypotheses. The proposed study is innovative in that it is the first to explore the~     impact of a complementary mind-body intervention on chronic inflammation in HIV-infected~     adults. Given that the consequences of early aging in this cohort will be a burden on the~     health care system as well as a medical, social and psychological burden on those living~     with HIV, the study has the potential to have a major public health impact.~   "
32861|NCT02626936|"~     In previous studies, investigators have studied if a pre-meal insulin bolus based on~     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without~     a significant degradation in postprandial glucose control. With this strategy, the patient~     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,~     large or very large) It is however important to establish safety of this simplified meal~     bolus approach. The safety of overestimating a meal insulin bolus in the context of single~     and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer~     simulation will be used to get a reasonable estimate of risks related to over-estimation~     with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be~     tested in adults with type 1 diabètes~      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus~     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an~     adequately estimated meal size bolus~   "
32862|NCT02626923|"~     Hypotension does not occur with Maraviroc at a dose of 600 mg/day~   "
32863|NCT02626910|"~     The project proposes to fill gaps in the understanding of disparities in healthcare and~     primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries~     with disabilities compared to those without disabilities. Studies document racial/ethnic,~     economic, and education-related disparities, but little is known about healthcare~     disparities related to disability.~   "
32864|NCT02626897|"~     This cross-over study of 12 patients with sarcoidosis will look at two different widely-used~     accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch.~     They measure daily activity levels. The investigators hope to use one of these devices in~     the future within a randomised-controlled trial looking at using methylphenidate for the~     treatment of sarcoidosis-associated fatigue. In order to ensure that the investigators~     choose the ideal device the investigators wish to compare the GENEActiv and ActiGraph GT3X~     devices. Participants will be required to wear the devices for 7 days each, with 6 patients~     beginning with the GENEActiv device and changing to the ActiGraph device after 7 days, the~     remaining 6 participants starting with the Actigraph before changing to the GENEActiv.~     Patients will complete a short exit questionnaire about their experience with the devices~     and their preference. The best device will be determined by both patient preference and~     reliability of collecting data.~   "
32865|NCT02626884|"~     The purpose of this trial is to determine~        1. Disease stabilization/response rate after six 21-day cycles of ibrutinib~        2. Remission status after six, twelve and 20 21-day cycles of ibrutinib~   "
32866|NCT02626871|"~     The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and~     major bleeding events in patients undergoing aortic valve replacement. This retrospective~     multicenter registry will include 850 patients with aortic valve replacement using~     bioprosthesis.~   "
32867|NCT02626858|"~     The aim of the present study is:~        1. to verify whether the delineation of the tumour bed, based on the combination of the~          visible postoperative changes and the position of the surgical clips on a CT scan in~          treatment position acquired 1 week before the start of the radiotherapy (RT), provides~          an accurate localisation of the boost volume compared to the localisation of the tumour~          on a pre-operative CT-scan.~        2. to document the changes that occur in the tumour bed as seen on a CT scan as a function~          of the delay between surgery and radiotherapy.~        3. to determine the ideal number and the positioning of the clips needed to reproduce the~          best treatment volume for the boost.~        4. to propose new guidelines for tumour bed definition and delineation based on the study~          findings.~   "
32868|NCT02626845|"~     This is a phase IV, single-center, randomized, placebo-controlled pilot study that will~     evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients~     with active otolaryngologic disease.~   "
32869|NCT02626832|"~     This study aims to develop a method for the assessment of central NMDA receptor functioning~     in patients with depression and schizophrenia. For this purpose a transitional approach is~     used based on preclinical studies that show a dose-dependent relationship between the~     activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma~     osmolality. Patients with schizophrenia, depression and healthy controls participated in~     this study. The Investigators found that in a subgroup of patients with schizophrenia the~     AVP response was low and that in a subgroup of subjects with depression the AVP response was~     high compared to healthy controls.~   "
32913|NCT02626247|"~     Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long~     chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in~     healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms)~     placebo-controlled design.~   "
32870|NCT02626819|"~     Compared to the general public, a higher percentage of Veterans are obese or overweight with~     a weight-related medical condition. The VA currently offers an effective weight management~     program called MOVE!, but the majority of eligible patients do not attend. Veterans see~     their primary care providers (PCPs) very frequently, making it an important place to receive~     information on weight management. However, PCPs often fail to discuss weight management with~     patients, so interventions are needed to encourage weight management counseling within the~     team-based care model used in primary care at the VA. Investigators used focus groups,~     interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG)~     intervention. This intervention combines online tools, counseling by a health coach, and the~     team-based care model to deliver weight management information to patients.~      Investigators will conduct a randomized controlled trial of 320 Veteran patients and their~     providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare~     System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual~     Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized~     weight management materials, health coach counseling, and go to their scheduled primary care~     (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone~     coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to~     assess body mass index, diet and physical activity, and goal attainment.~      The objectives of this study are to: (a) test the impact of the MTG intervention on weight~     and behavior changes; (b) identify predictors of weight loss in Veterans who use goal~     setting techniques; and (c) determine the impact of the MTG intervention on primary care~     team obesity-related counseling practices and attitudes.~   "
32871|NCT02626806|"~     1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients~          without CAD~        2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)~        3. To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT~          level in predicting CAD, either alone or in relation to traditional patient-related and~          exercise test-related metrics~   "
32872|NCT02626793|"~     The objective of this Non-interventional study (NIS) is the collection of data on the~     utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and~     treatment satisfaction on treatment with Apremilast in daily practice will be documented.~     Moreover, physician's and patient's assessments of the effectiveness and safety of~     Apremilast will be recorded.~   "
32873|NCT02626780|"~     The general objective of this study is to conduct a safety and feasibility study of a single~     injection of autologous adipose-derived SVF for the treatment of alopecia.~   "
32874|NCT02626767|"~     Low-volume high-intensity interval exercise training may improve aspects of health and~     fitness in young people, but interventions must be practical and engaging. The investigators~     examined the effect of a novel school-based low-volume high-intensity interval training~     programme on health, fitness and physical activity outcomes in adolescent school pupils. 101~     English adolescents aged 13-14 years took part in the study. Participants were healthy male~     and female volunteers, recruited from four schools in Northeast England. Using a~     non-randomised design, two schools took part in the intervention, and two were assigned to~     the control. Those in the intervention group completed a 10-week school-based high-intensity~     interval exercise training programme. The intervention took place three times per week, and~     comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and~     basketball drills), each interspersed with 90-s rest. Participants were encouraged to work~     maximally during the 45-s repetitions. Control participants were instructed not to change~     their lifestyle, dietary or physical activity habits during the intervention period, and~     maintain their normal school physical education routine. Study outcomes were blood lipid and~     glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness,~     physical activity levels, serum C-reactive protein levels and blood pressure.~   "
32875|NCT02626754|"~     This is a multi-national, phase II, single arm study to explore the safety/efficacy and~     potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell~     carcinoma.~   "
32876|NCT02626741|"~     The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective~     in the treatment of obesity patients with metabolic syndrome.~   "
32877|NCT02626728|"~     Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with~     single-port technology has allowed that pelvic surgery can be laparoendocopically performed~     from both its abdominal and perineal aspects.Previously, a strong negative association~     between medium- and long-term survival and male gender with narrow pelvis have been~     reported. TAMIS has a significant potantial for improving the quality of the surgical~     resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of~     patients have also a high rate of conversion to open surgery. Focusing on improvement in~     intraoperative conditions and surgical techniques rather than routine conventional~     procedures may be the way to go concerning favorable short- and long-term outcomes. The~     selection of adequate surgical approach to the high-risk patients with visceral obesity and~     a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve~     oncologic margin clearence. This is a prospective observational feasability study of the~     TAMIS-procedure.~   "
32878|NCT02626715|"~     The purpose of this study is to compare safety and efficacy of reduced-intensity~     conditioning and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS~     pediatric and young adult patients. This study investigates the use of two novel~     conditioning therapies for hematopoietic stem cell transplant (HSCT). The primary focus of~     both the investigators' myeloablative and reduced-intensity conditioning regimens is to~     reduce overall toxicity so that pediatric and young adult patients with high-risk AML/MDS~     with significant pretransplant comorbidities who would have been ineligible to proceed to~     HSCT previously can now receive potentially life-saving treatment.~   "
32879|NCT02626702|"~     Exploring the immune mediators of early pregnancy prospectively may help to identify new~     early interventions that will increase the likelihood of success and help women make~     informed decisions regarding their pregnancies.~   "
32880|NCT02626689|"~     This is a multi-site, prospective, observational study implemented in β-thalassemia~     treatment centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand).~     Approximately one to two study sites will be identified per country and approximately 20~     β-thalassemia subjects will be enrolled per country (10 transfusion dependent (TD) and 10~     Non-transfusion dependent (NTD) with a total of approximately 100 subjects. This study will~     not interfere with or influence the routine clinical management of β-thalassemia patients.~     Outcomes of interest will be collected prospectively for up to 6 months.~   "
32914|NCT02626234|"~     the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and~     rosuvastatin in patients with cMET-dysregulated advanced solid tumors~   "
32881|NCT02626676|"~     Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as~     possible in order to minimize the complication-related risks. Encouraging patients to adhere~     to their treatment plans is a great challenge for health care professionals. Objectives: The~     aim of this study is to evaluate the impact of a nutrition educational programme on the~     hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods:~     A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D~     Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The~     educational intervention consists of lectures and group dynamics sessions performed during~     dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum~     phosphorus concentration will be evaluated and the transtheoretical model of eating behavior~     (TMFB) will be applied pre- and post-intervention.~   "
32882|NCT02626663|"~     The investigators propose to characterize MPs in aHUS and TTP both at the onset and~     throughout treatment. The investigators believe that the number, size, and cell origin of~     MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs~     will be higher in number and comprise a larger portion of the MP population in aHUS and that~     platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The~     investigators believe that MP identity and number can be used to reliably differentiate~     between aHUS and TTP at disease onset.~   "
32883|NCT02626650|"~     College athletes will be recruited to complete a voluntary online survey that will take~     approximately 10 minutes. In this survey, they will answer a series of questions related to~     the concussion symptoms they have experienced in their recent sports season, their opinions~     related to concussions and concussion treatment, and demographics.~   "
32884|NCT02626637|"~     During cancer treatment children are less active than their health peers. This inactivity~     persists into survivorship and can negatively affect health and quality of life. Physical~     activity may also improve fatigue, a prevalent and distressing symptom during treatment.~     Improving health behaviors during treatment can have lifelong benefits for cancer survivors.~     In this study, the effectiveness of the Kids are Moving exercise program will be~     evaluated. The exercise program will follow program guidelines set up by the American~     College of Sports Medicine and will be adapted for children with cancer. Children ages 6 to~     18 years, who are receiving chemotherapy, and their parents, will be coached on how to~     increase their physical activity and will receive an exercise prescription. This will occur~     as part of the standard care they receive from the nurse practitioners during the first six~     months of their outpatient visits. Investigators want to find out if children in the Kids~     are Moving program are more active and have less fatigue. Activity will be measured through~     patient questionnaires about activity and fatigue, and by wearing the FitBit activity~     tracker and an actigraph. Outcomes will be compared to measurements collected from children~     who received usual care before the exercise program started.~      Physical activity is a vital for improving health and quality of life and for providing~     energy for engaging in positive life experiences as children move along the developmental~     continuum to a long and healthy future. Outcomes of the study will provide a foundation for~     larger multi-site clinical trials.~   "
32885|NCT02626611|"~     This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted~     at multiple centers in the U.S. All subjects will receive oral immunotherapy for their~     specific food allergies (limited to 5 of those food allergens in Investigational New Drug~     (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens~     will be introduced in a rush desensitization day at week 8. Subjects will return to clinic~     to escalate the dose of their allergens until 2,000mg protein of each allergen is reached~     Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are~     nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to~     one of three double blinded arms: Arm A- continue with current dose (2000 mg each food~     allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food~     allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to~     each allergen at week 36. The final challenge of week 36 will be the final end of study~     visit.~      Safety is a paramount concern in the study design and will be monitored carefully throughout~     the study. Study subjects and their parents/guardians will receive extensive education on~     food allergy reactions and medication use.~   "
32886|NCT02626598|"~     This is a single center study for adult females or males ages 25 to 75 years who are seeking~     treatment for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or~     nasolabial folds, and/or melolabial folds, and/or forehead. The purpose of this study is to~     evaluate blended Belotero for the treatment of etched-in fine facial lines and to monitor~     for adverse events.~   "
32887|NCT02626585|"~     The purpose of this study was to investigate the effectiveness of postrhinoplasty taping.~     The effectiveness was evaluated with Ultrasonography and skin envelope thickness was~     prospectively measured for analysis.~   "
32888|NCT02626572|"~     The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in~     patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An~     optional 28-week extension period will be performed to evaluate safety/tolerance and~     efficacy of S47445 in co-administration with donepezil.~   "
32889|NCT02626559|"~     Serum levels of bupivacaine over time after peri-articular injection of a mixture of~     liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.~   "
32890|NCT02626546|"~     This is a multicentre, prospective, observational cohort study. Consecutive patients,~     operated in six University Hospitals in Sweden will be recruited following major surgical~     procedure. The length of patient recruitment period will be 12 weeks. The length of follow~     up will be 360 days . The objectives are to determine the postoperative morbidity (during~     the hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes~     and to identify risk factors that may potentially be influenced by any intervention in the~     future.~   "
32952|NCT02625740|"~     The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate~     the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy~     to improve local Paclitaxel delivery effects in critical limb ischemia patients due to~     femoral-popliteal artery disease.~   "
36778|NCT02575612|"~     The study aims to evaluate the ability of representative vacuum-assisted minimal invasive~     biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients~     after neoadjuvant chemotherapy (NACT).~   "
32891|NCT02626533|"~     Persistent pain and joint stiffness after surgery may interfere with recovery and adversely~     affect quality of life in up to 40% of patients who have undergone total knee arthroplasty.~     There is growing evidence that inflammation as well as other medical and psychological~     factors may be associated with osteoarthritis severity, progression, and associated pain~     severity. This study aims to identify clinical, biological, and psychological factors that~     contribute to and predict the development of these complications. Identification of such~     factors may allow us to target preventative measures to the patients at highest risk of~     persistent postoperative pain and joint stiffness.~   "
32892|NCT02626520|"~     Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease~     will be treated with standardized systemic chemotherapy, followed by chemoradiation, and~     then surgical resection for those with resectable or borderline resectable disease. The~     primary endpoint is disease-free survival at 1 yr from initiation of treatment.~   "
32893|NCT02626507|"~     This is a dose-escalation Phase Ib clinical trial in 18 patients with newly diagnosed Stage~     I-IV ER+/HER2- breast cancer, with the primary cancer in place. These patients have not~     received prior therapy for their breast cancer and intend to undergo surgery after four~     cycles of therapy.~      This is an open-label study, and investigators and subjects are not blinded to the~     treatment. The reason for using an open-label study design is because this is a~     dose-escalation trial, and the investigators need to determine the potential toxicity before~     a decision can be made to continue the dose escalation procedures.~      The assignment of patients will not be randomized, as this is a dose-escalation trial.~   "
32894|NCT02626494|"~     This study aims at testing for the impact of glutamatergic changes on drug craving in~     cocaine addiction, and to evaluate the effects of n-acetylcysteine (n-AC) on both glutamate~     homeostasis and craving using a randomized, double-blind, placebo controlled cross-over~     design.~   "
32895|NCT02626481|"~     This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in~     MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease,~     resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.~      There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling~     have already been determined in previous phase 1-2 dose escalation studies. There is no~     randomization.~   "
32896|NCT02626468|"~     Validation of Structured Light Plethysmography (SLP) in patients with conditions such as~     Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy~     participants.~   "
32897|NCT02626455|"~     The purpose of this study is to assess whether copanlisib in combination with standard~     immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in~     combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and~     prednisone/prednisolone [R-CHOP]) is effective and safe compared with placebo in combination~     with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have~     received at least one, but at most three, lines of treatment, including rituximab and~     alkylating agents.~   "
32898|NCT02626442|"~     The risk of stroke and vascular dementia is high in individuals who have had a prior stroke~     or TIA, and in those who have vascular disease risk factors, such as high blood pressure,~     abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with~     exercise. This study will examine the impact of a 6 month, low intensity group exercise~     class on fitness, walking, balance, and brain health.~      This study will also collect fitness, walking, balance, and brain health outcome measures at~     baseline and post all other MERCE exercise and robotics interventions.~   "
32899|NCT02626429|"~     Protein requirements in active individuals have been suggested to be greater than the~     current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order~     to characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in active, young adult~     females using the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
32900|NCT02626416|"~     The incidence rate of postoperative capsular opacification (PCO) in children after cataract~     surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy~     is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term~     follow-up, timely diagnosis and treatment is important to improve patient's outcome.~      The major and central part of lens is easy to be observed through a dilated pupil.~     Especially, opacification in the lens and/or lens capsule is distinctive showing as white~     on the black background. The characteristic features of the disease and advances in~     photographic technique with mobile phone make it possible for patients and/or their~     guardians to monitor the progress of cataract or PCO with mobile application in a~     self-help manner under non-clinical settings.~   "
32901|NCT02626403|"~     Previous studies showed that anodal transcranial direct current stimulation (tDCS)~     transiently improves performance of memory and attention. In severely brain injured patients~     with disorders of consciousness (DOC), a single stimulation over the left dorsolateral~     prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other~     brain areas could be stimulated in order to increase the number of responders. In this~     study, investigators will assess the effects of bilateral fronto-parietal tDCS on Coma~     Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled~     experimental design.~   "
32953|NCT02625727|"~     Using double blind, randomized controlled design to study the immediate, short-term and~     intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and~     hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.~   "
32954|NCT02625714|"~     A randomized, open-label, oral multiple dosing, two-part, two-way crossover clinical trial~     to evaluate the safety/tolerability and pharmacokinetic profiles of SID142 in healthy~     volunteers~   "
33615|NCT02617069|"~     The aim of this prospective randomized double-blind study was to compare the efficacy of~     botulinum toxin injection in epicardial fat pads for preventing recurrences (in early~     postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.~   "
32902|NCT02626390|"~     This study examined the feasibility of using implicit and explicit learning approaches~     during gait rehabilitation in the early phase following stroke. It was a double blind trial~     (participants and assessors) using a matched pairs design. Participants were recruited from~     an acute stroke unit, and were randomised to receive gait rehabilitation over three~     consecutive days using either an implicit or explicit approach. Guidelines for each were~     developed empirically, including differences in the amount, timing, and attentional focus of~     therapists' verbal communication. Sessions were recorded and their content analysed to~     establish concordance with the guidance. Clinical measures were taken at baseline and 24~     hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able~     to adhere to the guidance. Both approaches were found to be acceptable to both patients and~     therapists. The findings will be used to design an appropriately powered RCT.~   "
32903|NCT02626377|"~     Medical progress and modification of lifestyles have prolonged life expectancy, despite the~     development of chronic diseases. The support and care are often provided by a network of~     informal caregivers composed of family, friends, and neighbors. They became essential to~     help maintening the elderly persons to live at home. It has been demonstrated that the~     importance and the diversity of informal tasks may jeopardize their own physical, mental and~     social well-being.~      The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study~     of their life course, the profiles of caregivers of patients with a diagnosis of one of the~     following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases~     (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases~     (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease~     (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following~     the different phases of the caregiving relationship from the announcement of the diagnosis,~     it will be possible to assess the quality of life of caregivers and evaluate the~     implementation of a pragmatic social action to help informal caregivers through a randomized~     intervention trial nested in the cohort.~      Thanks to an analytical and longitudinal definition of the profiles of informal caregivers,~     this study could gather precise information on their life courses and their health~     trajectory by identifying the consequences associated with the concept of their role of aid~     in care. In addition, the randomized intervention trial will explore the efficacy, in terms~     of quality of life, and efficiency of a social action to support the caregivers. These data~     will allow to identify strategies that could be used to improve the existing sources of aid~     and to propose new approaches to help caregivers. This study will provide the opportunity to~     identify the most relevant means of support and to give an impulse for new healthcare~     policies.~   "
32904|NCT02626364|"~     This is a proof of concept, single-arm study to investigate crenolanib monotherapy in~     patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing~     the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at~     100 mg TID continuously until disease progression, unacceptable toxicity, or consent~     withdrawal.~   "
32905|NCT02626351|"~     This study evaluates the impact of a quality improvement (QI) intervention on maternal and~     child healthcare services in seven primary healthcare (PHC) clinics, in a rural setting of~     KwaZulu-Natal, South Africa.~   "
32906|NCT02626338|"~     The proposed study is designed to combine crenolanib with standard salvage chemotherapy to~     treat patients with R/R AML irrespective the FLT3 status.~   "
32907|NCT02626325|"~     High saturated fat acids diets are associated with elevated blood pressure which is~     associated with cardiovascular morbidity and mortality. For this reason, a change of diet is~     recommended to manage blood pressure and prevent cardiovascular complications. To achieve~     this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be~     advised in the replacement of a saturated fat diet.~      Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood~     pressure lowering after consumption of a high-monounsaturated-fat diet compared with a~     high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of~     Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than~     diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.~      For this reason, a new meta-analysis of a randomized clinical trial will be performed to~     clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood~     pressure. Results from this meta-analysis will help health professionals take important~     decisions on patient diet and minimize cardiovascular morbidity and mortality.~   "
32908|NCT02626312|"~     At this time, patients who have a cancer in the liver and who already have liver damage from~     cirrhosis, chemotherapy, or surgery may not be able to receive radiation therapy to the~     liver. Radiation to the liver in these patients may cause excessive liver damage. New~     methods of giving radiation to the liver may help these patients receive radiation therapy~     to help control cancer.~      The goal of this clinical research study is to find out if the new method of giving~     radiation to the liver can be given safely to patients who already have liver problems.~   "
32909|NCT02626299|"~     The purpose of this study is to determine if giving a larger amount of DHA than currently~     included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks~     of pregnancy).~   "
32910|NCT02626286|"~     The objective of the study is to evaluate the feasibility and interest of a HIV quarterly~     preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help~     reducing HIV incidence in this key population, their female partners, and the general~     population. This interventional, open label, multicenter, multidisciplinary cohort study~     will be conducted in Burkina Faso, Ivory Coast, Mali and Togo.~      All participants will receive a HIV quarterly preventive global care including:~      i) data collection on health status, symptoms of sexually transmitted infections (STI) and~     sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv)~     counselling adapted for MSM, and v) the provision of condoms and lubricants.~   "
32911|NCT02626273|"~     The present protocol is mainly involved in the understanding of the local interaction~     between the released products by fat tissue and hormones production of bone tissue. These~     complex interactions between adipocyte and osteocyte activities could explain the mechanisms~     of the body responses to the strategies of weight loss that include diet and/or physical~     activity program, as well as the side effects encountered by these interventions.~      Adolescence is a period of development characterized by many metabolic and somatic changes~     that may influence weight. Weights bearing physical activities are a key factor allowing~     body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and~     the onset of overweight and obesity during this very important growth spurt lead to various~     hormonal dysregulation. The specific mechanisms of the evolution and interactions between~     these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to~     analyze the possible connections between fat tissue and the quality of the skeleton in order~     to reduce related risks of the consequence of weight loss in obese individuals.~   "
32912|NCT02626260|"~     The study investigates the impact real output has on the adhesion of adhesives.~   "
32915|NCT02626221|"~     This is a non-interventional, multi-country, Latin American study utilizing a prospective~     single-cohort design. Eligible CU patients will be enrolled in the study and will be~     followed for 24 months (± 6 weeks).~      In accordance with the observational nature of the study, there will be no interventions or~     interference with the routine care of the patient which will be based solely on the clinical~     judgment of the treating physician. However, with respect to the frequency and schedule of~     assessments, the schedule included in Table 7-1 will be recommended.~      The selection of the treatment for CU will be clearly separated from the decision to include~     the patient in the study, and will be made at the discretion of the treating physician in~     accordance with standard medical practice, the investigator's clinical judgment, and global~     urticarial guidelines.~      In order to prevent selection bias, investigators should offer enrollment to all consecutive~     patients meeting study criteria, likely to be available for the full duration of the~     follow-up period of 24 months, and willing to participate in the study.~      The overall objective of the study is to evaluate in real-life the CU disease burden, the~     current treatment patterns and the use of health care resources in patients refractory to~     H1-antihistamine treatment~   "
32916|NCT02626208|"~     This clinical trial investigates a new vaginal delivery system made of silicone rubber,~     containing Nestorone®, a 19—nor progesterone derivative and a low dose of serum estradiol~     (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels~     of three different contraceptive vaginal rings that contain a fixed dose of NES and~     escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for~     selecting a CVR for a larger contraceptive efficacy trial.~   "
32917|NCT02626195|"~     Malnutrition patients are known to have more postoperative complications and mortality. And~     most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and~     mortality rate. Therefore for the malnourished patients anticipating major surgery,~     preoperative nutritional support is recommended according to the ASPEN (American society of~     parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral~     nutrition) guideline. However there is no prospective trial to prove the clinical impact of~     preoperative nutritional support for malnourished patients.~      The purpose of this study is to evaluate the clinical impact of preoperative nutritional~     support for malnourished cancer patients anticipating HBP surgery. Primary objective is to~     compare the complication rate and secondary object is to compare the quality of life,~     hospital stay and cost.~   "
32918|NCT02626182|"~     This study evaluates the ability of the drug sildenafil to improved exercise capacity,~     cardiac performance during exercise, and quality of life in patients with moderate to severe~     CF lung disease. 3/4 of the subjects will receive sildenafil and 1/4 will receive placebo.~   "
32919|NCT02626169|"~     Ticagrelor and clopidogrel are FDA-approved drugs for inhibition of platelet~     hyper-reactivity in certain clinical situations. The platelet inhibition and patient~     outcomes (PLATO) trial showed that in patients with acute coronary syndromes, ticagrelor~     significantly reduced the primary endpoint (cardiovascular death, myocardial infarction or~     stroke), all-cause mortality and cardiovascular mortality compared to clopidogrel. It has~     been suggested that in addition to its anti-platelet effects, ticagrelor has additional~     unique effects, including anti-inflammatory effects that are not shared by clopidogrel. In~     the present study the investigators will assess whether ticagrelor, as compared to~     clopidogrel, increases serum levels of 15-epi-lipoxin A4, a potent endogenous~     anti-inflammatory mediator.~   "
32920|NCT02626156|"~     The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management~     ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic~     foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month~     randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of~     cooling gel pack or placebo will be applied three times weekly to the affected skin, and a~     bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes~     elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and~     quality of life will be measured.~   "
32921|NCT02626143|"~     This study is intended to compare growth, nutritional status, and brain development in~     children fed an Investigational cow's milk based formula containing a nutrient-rich whey~     protein, a standard cow's milk based formula, or fed exclusively breast milk.~   "
32922|NCT02626130|"~     The goal of this clinical research study is to compare the safety and effectiveness of~     tremelimumab alone and in combination with cryoablation in patients with metastatic kidney~     cancer having surgery. Researchers also want to learn how the combination may affect the~     immune system.~      Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and~     destroy cancer tissue.~   "
32923|NCT02626117|"~     The concept of laser deepithelialization to retard epithelial migration has enabled new~     attachment formation in periodontal pockets. Based on this hypothesis, that laser~     deepithelialization during root coverage procedures will enhance clinical outcome, a split~     mouth randomized controlled clinical trial was planned to compare the clinical outcome of~     Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in~     combination with laser de-epithelialization in the treatment of gingival recession.~   "
32924|NCT02626104|"~     This prospective, randomized, parallel-group, double blind, single-center study is to be~     conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in~     following departments: Department of Paediatric Gastroenterology and Nutrition, Department~     of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department~     of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include~     a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy~     because of acute respiratory tract infection/or urinary tract infection. The children will~     be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally~     for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of~     diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a~     watery or loose stool with/or occurrence of blood in the stool.~   "
32925|NCT02626091|"~     The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented~     with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to~     validate the accuracy of this technique with metabolic intestinal cells changes.~   "
32926|NCT02626078|"~     Nutrition is an essential component of health and a key determinant of aging and quality of~     life of individuals. Malnutrition in the elderly is now recognized as a public health~     problem affecting nearly half of residents in nursing homes. The fight against malnutrition~     requires to rethink the meal in all its dimensions, beyond the nutritional needs. In order~     to improve practices of care at the elderly, the impact of environmental and social aspects~     of food in nursing homes has been assessed. The social environment and interactions during~     the meals are now identified as effective ways to stimulate food intake and increase~     feelings of well-being in the elderly.~      The objectives of the study are to characterize the appreciation of food and social~     interactions during the meals and to study the relationships between the quality of food~     practices and nutritional status of the residents in nursing homes to improve their quality~     of life.~   "
32927|NCT02626065|"~     This is an open mono-centric prospective non-randomized study in patients with metastatic~     melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to~     identify the immune cells modulations differences between patients who present a complete,~     partial or stable response and patients who have non-response to the therapy in order to~     establish an improving response rate strategy.~   "
32928|NCT02626052|"~     The purpose of this study is to explore the diagnostic values associated with both a~     positive and negative Skull Vibration Induced Nystagmus Test (SVINT) performed in room light~     (with fixation). The hypotheses include: 1. A positive room light SVINT will be identified~     in individuals with moderate to severe vestibular asymmetries. 2. A positive room light~     SVINT will be present when 10 beats or more (counted over 10 seconds) of nystagmus are found~     with fixation blocked.~   "
32929|NCT02626039|"~     Characterization of the driver mutations in an individual metastatic breast cancer patient~     is critical for many reasons. Effective targeted therapies require identifying genomic~     alterations in the tumoral tissue. The scarce efficacy of many currently available targeted~     drugs may be due to the outbreak of resistant clones with different genotype that already~     present at the initiation of therapy. It is well known the intra-tumor heterogeneity with~     genetic and non-genetic factors considered as the origin of the tumor cell-clon composition.~     The acquisition of multiple mutations (driver and passenger), altogether with the stage of~     differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells~     clinically important properties, such as resistance to therapies and seeding abilities.~      Moreover, there is a current challenge in establishing whether the metastatic cells arise~     from the most aggressive and dominant clone in the primary tumor or the metastasic tissue~     diverges with substantial genetic changes very early in the evolution of the disease.~     Primary and metastatic tumor may have a close clonal relationship or evolve in parallel and~     acquire different genomic alterations. In the real life, it is plausible that both models~     coexist with different predominance according to the tumoral tissue and etiology.~      The study hypothesizes that breast cancer metastases and primary tumors could harbor~     different genomic profiles related to genomic regions of interest in a clinically relevant~     proportion of metastatic breast cancer patients.~      Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be~     detected in CTCs and circulating free DNA.~      If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible~     sources of genomic material for the analysis of mutations and other genomic aberrations.~   "
32930|NCT02626026|"~     This study will consist of two parts: Part A will evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of GS-4059 in healthy participants. Part B~     will evaluate the safety, tolerability, and the effect of GS-4059 on disease-specific~     clinical markers and outcomes in participants with rheumatoid arthritis (RA).~   "
32931|NCT02626013|"~     This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical~     outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat~     population. Notably, the data generated in the context of this study will serve as~     complementary evidence to that of the tightly and strictly controlled pre-registration~     clinical trial setting, which is of essential importance especially in patient populations~     with diseases of complex and heterogeneous biology, such as breast cancer.~   "
32932|NCT02626000|"~     A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in combination with~     Pembrolizumab for the Treatment of Subjects with Recurrent or Metastatic Squamous Cell~     Carcinoma of the Head and Neck~   "
32933|NCT02625987|"~     To compare the results associated with two different skin closure techniques in open~     appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency~     department. They were grouped randomly into two groups: patients who would receive skin~     closure with skin closure by an unique absorbable intradermic stitch (Group A) and another~     that would receive a habitual technique consistent in non absorbable separated stitches~     (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities~     and allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics~     previously, complicated or uncomplicated appendicitis, surgery time and wound complications~     like skin infection, dehiscence, seroma or abscess were registered in each case too,~   "
32934|NCT02625974|"~     This study was designed to develop a better understanding of the efficacy,~     safety/tolerability, and pharmacokinetics (PK) (absorption, distribution, metabolism, and~     elimination) of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma~     cruzi infection) using pediatric formulations.~   "
32935|NCT02625961|"~     In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC)~     unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for~     or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The~     primary study hypothesis is that treatment with pembrolizumab will result in a clinically~     meaningful response.~   "
32936|NCT02625948|"~     The purpose of this study is to determine if computed tomography angiography can predict~     which individuals with intracerebral hemorrhage will experience significant growth in the~     size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the~     study will compare the drug Tranexamic acid to placebo to determine the effect and safety of~     on intracerebral hemorrhage growth~   "
32937|NCT02625935|"~     This multicenter, prospectively designed study examines whether the Prosigna score~     influences physician and patient adjuvant treatment selection over and above currently used~     prognostic factors. This study also examines the impact of the test results on patients'~     reported outcomes, including their decisional conflict status and anxiety levels.~   "
32938|NCT02625922|"~     This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II~     clinical study to evaluate the effect of serelaxin versus placebo (both in addition to SoC)~     on the release of hs-cTnI, in patients with CHF after an exercise testing session.~   "
32972|NCT02625480|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric~     or adolescent subjects.~   "
32939|NCT02625909|"~     The aim of the study is to determine if treatment for recently acquired hepatitis C~     infection (with or without HIV coinfection) can be shortened when treating with the~     interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL).~      SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the~     hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to~     be highly effective (SVR12 >95%) when given for 12 weeks.~      Data has shown that treatment can be shortened when treating recently acquired HCV with~     interferon containing treatments. It is not known whether treatment with SOF/VEL can be~     shortened.~      This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent~     to treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C~     infection. The project is a randomised study where both participants and investigators would~     not find out the treatment duration of the participants until week 6 of treatment.~   "
32940|NCT02625896|"~     This study aims to evaluate the use of an aerial human body manoeuvre to reduce the~     biomechanical load on the neck of a parachutist during the parachute opening, in order to~     create a basis for future prevention of skydiver neck pain in the parachutist population.~   "
32941|NCT02625883|"~     The investigators will retrospectively examine all patients with out-of-hospital~     resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the~     year 2013 with a one year follow-up and a structured interview about Quality of life.~     Furthermore, the costs generated by the local health system are analysed.~   "
32942|NCT02625870|"~     The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl~     Esters 90 Soft Capsules and placebo. The primary objective of the present study was to~     evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects~     with severe hypertriglyceridemia (TGs ≥500 mg/dL but ＜2000 mg/dL).~   "
32943|NCT02625857|"~     The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of~     JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in~     which two virulence genes, which encode molecules that help cause disease, have been~     removed) when administered intravenously to participants with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
32944|NCT02625844|"~     This study is to document the time spent by health care personnel on anemia-related tasks,~     including preparation, distribution and administration of monopegylated epoetin beta~     (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal~     disease in hemodialysis centers in Croatia. The total average time will be determined for~     the same number of patients on monopegylated epoetin beta and patients on other ESAs. In~     addition, qualitative information will be obtained on changes in practice patterns that may~     have occurred with the introduction of monopegylated epoetin beta.~   "
32945|NCT02625831|"~     Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the~     production of multiple autoantibodies. Antibodies against Ficolin-3 were previously~     identified in the sera of some SLE patients, but their prevalence and significance have not~     been yet investigated. The aims of this study were to determine the prevalence of~     anti-ficolin-3 antibodies among SLE patients and to investigate their potential as~     diagnostic and/or prognostic biomarkers in SLE. In this retrospective study, clinical data~     were obtained from medical files and blood samples were selected from preexisting biological~     collection. SLE patients (n=165) were informed and did not objected, they were matched to~     healthy controls (n=48). Disease activity was determined according to the SLEDAI score.~     Anti-ficolin-3, anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels were measured in~     sera by ELISA. First, a highly significant difference was found in the anti-ficolin-3 levels~     between SLE patients and healthy subjects. Anti-ficolin-3 antibodies were detected as~     positive in 58 of 165 (35%) SLE patients. The titer of anti-ficolin-3 and anti-ficolin-2~     antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-3~     antibodies was associated with anti-ficolin-2 antibodies, anti-C1q and anti-dsDNA~     antibodies. Regarding associations with clinical manifestations, only the presence of active~     lupus nephritis was significantly associated with the presence of anti-ficolin-3 antibodies~     (p=0.0001). This association with renal involvement was higher with anti-ficolin-3~     antibodies than with other auto-antibodies. Interestingly, the combination of~     anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than~     any other traditional biomarker. These results suggest that anti-ficolin-3 antibodies could~     be useful for the diagnosis of active nephritis in SLE patients.~   "
32946|NCT02625818|"~     A major proportion of patients admitted to psychiatric acute and emergency departments have~     symptoms, behaviors or function influenced by implicit or explicit suicidal intention~     (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in~     the acute phase during in-patient stay and after discharge. At present there is no~     satisfactory tool to predict post-discharge suicide risk.~      Multidimensional rating is expected to have better predictive properties than~     one-dimensional rating for suicidal behavior during in -patient stay and two years after~     discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and~     ideations, as well as therapist's reactions during interviews. In the present study the~     predictive properties of two rating scales for suicidal behavior during in-patient stay and~     two years after will be compared. One of these is a multidimensional scale:~     Multidimensional Assessment of Suicide Risk (MARIS).~   "
32947|NCT02625805|"~     This study evaluates the ability to support diagnosis and monitor of the dynamics in~     ADD/ADHD subjects with an easy to use EEG Device.~   "
32948|NCT02625792|"~     SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But~     after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer~     bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation~     treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer~     bigger than 40mm in size is also associated.~      Though several previous study have failed to show efficacy of 2nd look EGD, but those~     reports pointed out that visible vessels with current bleeding or highly suspect of recent~     bleeding (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at~     high risk of bleeding.~      So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a~     significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus~     visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And~     finally this protective effect might have an effect for prophylaxis of post ESD ulcer~     bleeding.~   "
32949|NCT02625779|"~     This research is aimed to investigate the efficacy and safety of the creatine and cytidine~     augmentation in treating bipolar depression and to evaluate changes in relevant brain~     biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.~   "
32950|NCT02625766|"~     Lateral compression type pelvic ring injuries remain the most common type of pelvic~     fractures encountered. There is a substantial amount of controversy surrounding the~     treatment of these injuries and there is evidence that both operative and non-operative~     treatment can be successful.~   "
32951|NCT02625753|"~     Compare the use of codeine/paracetamol against placebo for pain control after cornea~     photorefractive keratectomy (PRK).~   "
32955|NCT02625701|"~     There is no ideal cookbook recipe for fluid prescription that would fit every surgical~     patient.~      In this study, the investigators working hypothesis is that the adoption of an integrative~     algorithm for perioperative fluid and haemodynamic management would improve clinical outcome~     and reduce hospital resource utilization in noncardiac surgical procedures~     (major-to-intermediate level of stress.~      Two intraoperative fluid strategies will be compared: Restrictive vs. goal-directed~     therapy (GDT). In the GDT group, haemodynamic information will be obtained by a flow~     monitoring device coupled with standard heart rate and blood pressure monitoring.~   "
32956|NCT02625688|"~     Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of~     years. Based on published data, numerous neonatal benefits have been suggested such as~     increased hemoglobin and ferritin levels both at birth and longer term. Available systematic~     reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other~     neonatal outcomes including polycythemia and hyperbilirubinemia.~      A review published nearly 10 years ago regarding late umbilical cord clamping revealed only~     4 studies which as a second objective assessed whether the time of cord clamping was~     associated with an increased risk of polycythemia and hyperbilirubinemia during the first~     week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No~     information is provided on what hour of life the bilirubin levels were measured exactly.~      In this randomized control study the investigators would like to determine if delayed cord~     clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring~     phototherapy) in term infants.~   "
32957|NCT02625675|"~     The observational pilot study at the Churchill Hospital, funded by Oxford Respiratory Trials~     Unit, will assess the feasibility and efficacy of thoracic ultrasound (TUS) assessment in~     patients undergoing talc pleurodesis via intercostal chest drain (ICD) for recurrent~     symptomatic malignant pleural effusions (MPE). Participants will undergo TUS pre and post~     pleurodesis on up to four occasions. We hypothesise that a TUS scoring system will be able~     to predict short and long-term pleurodesis success earlier than current conventional medical~     practice allows. This study may ultimately allow the proposal of a treatment algorithm to~     manage patients with MPE in a more efficient manner.~   "
32958|NCT02625662|"~     This study will focus on the symptoms, natural history and clinical impact of~     facioscapulohumeral muscular dystrophy (FSHD) in children.~      Symptoms of classical FSHD start in adulthood. However, a small subgroup of FSHD patients~     have an early, childhood onset. This early onset is associated with faster progression and~     other symptoms like hearing loss and epilepsy.~      The symptoms, natural history and clinical impact of FSHD in children are largely unknown.~      The results of this study will be vital for adequate symptomatic management and~     trial-readiness.~   "
32959|NCT02625649|"~     This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2~     diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and~     remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB.~     Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular~     complications such as nephropathy and retinopathy. Finally, the study provides insight into~     the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota~     diversity and bile acid levels.~   "
32960|NCT02625636|"~     Primary Objective:~      To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC)~     doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.~      Secondary Objective:~      To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of~     SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.~   "
32961|NCT02625623|"~     The purpose of this study is to demonstrate superiority of treatment with avelumab plus best~     supportive care (BSC) versus physician's choice (chosen from a pre-specified list of~     therapeutic options) plus BSC.~   "
32962|NCT02625610|"~     The purpose of this study is to demonstrate superiority of treatment with avelumab versus~     continuation of first-line chemotherapy.~   "
32963|NCT02625597|"~     The primary purpose of this study is to determine what effect, if any, do different dental~     materials used to seal the prosthetic screw channels of implant supported restorations have~     on dental implant health parameters and microbiology.~   "
32964|NCT02625584|"~     The aim of this project is to determine how shared reading promotes child language~     development, and to use this knowledge to make it an effective language-boosting tool for~     children from all social and economic backgrounds.~   "
32965|NCT02625571|"~     A significant minority of children (ages 5-12) display problematic sexual behavior and the~     persistence of this behavior is oftentimes as stable as other child behavior problems, such~     as aggression and defiance. Unfortunately, the only tested intervention protocols for these~     concerns utilize a group treatment modality that is not feasible in most community treatment~     settings. This project will define and pilot test an intervention for child sexual behavior~     problems that is applicable in most settings and can be easily disseminated as a first step~     toward validation in larger clinical trials.~   "
32966|NCT02625558|"~     Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary~     hypertension~   "
32967|NCT02625545|"~     The purpose of this study is to evaluate the safety and effectiveness of using UroLift in~     subjects with a prostatic median lobe enlargement due to BPH.~   "
32968|NCT02625532|"~     Exploratory, prospective, randomized, comparative, open trial with control group treated to~     assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase~     ovarian stimulation in women with Bologna criteria for poor ovarian response.~   "
32969|NCT02625519|"~     Exploratory, prospective, randomized, comparative, open trial with control group treated to~     assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be~     influenced by genotype of receptor N680S FSH Gene Polymorphism.~   "
32970|NCT02625506|"~     The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine~     in the reduction of postoperative pain, postoperative opioid consumption after modified~     radical mastectomy surgery.~   "
32971|NCT02625493|"~     The purpose of this study is to determine the preference of patients regarding the vascular~     access site in future coronary procedures. We hypothesize that patients prefer the lesser~     invasive procedure via radial access.~   "
32975|NCT02625441|"~     This randomized clinical trial compares two systemic treatments for HER2-positive breast~     cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment)~     or after breast surgery (as adjuvant treatment). In the investigational group (Group A) the~     study participants will receive a combination of two drugs directed at HER2 (two anti-HER2~     antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients~     allocated to the comparator group (Group B) will be treated with chemotherapy plus one~     anti-HER2 treatment (trastuzumab) for one year.~   "
32976|NCT02625428|"~     This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help~     evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus~     help direct the biopsy to the most abnormal part of the renal cortex. This should maximize~     detection and increase the odds of demonstrating the true grade/severity of the~     histopathological abnormality.~   "
32977|NCT02625415|"~     The study is designed to test the effectiveness of topical B6 cream in patients that~     developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).~   "
32978|NCT02625402|"~     This pilot RCT study is to examine the comparative effectiveness of two decision aids for~     hip and knee osteoarthritis.~   "
32979|NCT02625389|"~     This study is multicenter (up to 10 sites in India) phase IV Post-Marketing Study. The study~     is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical~     glues according to each site medical practice during vascular embolization. Subjects will be~     enrolled prospectively with the main condition that they are eligible for vascular~     embolization using Lipiodol® Ultra Fluid in association with surgical glues. The~     per-procedure safety evaluation will be enabled by appropriate records of safety events~     during the time frame of the session of vascular embolization using Lipiodol® Ultra Fluid in~     association with surgical glues. According to the patient needs and health status a second~     vascular embolization using the same products may be considered by the investigator within~     the next 30 days after the first one. Safety evaluation will be completed with safety~     records up to one month after the last embolization session. Efficacy evaluation will rely~     on the level of lesion(s) obliteration after embolization. Exploratory descriptive~     statistical methods will be used to evaluate safety and efficacy, using both the total~     population and subsets of subjects with similar clinical conditions.~   "
32980|NCT02625376|"~     This is an interventional, prospective, randomized, comparative monocentric study aiming to~     evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative~     Age-Related Macular Degeneration.~   "
32981|NCT02625363|"~     Glycemic index concept is widely used to determine impact of a food to blood glucose.~     Several studies showed that water content and intake after meal may influence glycemic~     response of the meal and thus have an effect on the result of GI measurement. Currently~     these studies found conflicting results. Therefore, this study aims to determine whether~     water intake, specifically after meal, may influence the glycemic response and glycemic~     index value of the meal.~   "
32982|NCT02625350|"~     Glycemic index is commonly used as a method to determine the effect of a food to blood~     glucose. Despite its carbohydrate and fat content, instant noodle is very popular in Asia,~     including Indonesia. Based on the serving method, there are instant noodle without and with~     soup. Studies have shown that water content of a meal may influence glycemic response of the~     meal and thus have an effect on the result of GI measurement. However none specifically~     studied instant noodles nor the additional water content as soup (not incorporated in the~     food matrix). Therefore, this study aims to determine whether the serving method of instant~     noodle (with and without soup) may influence the glycemic response and glycemic index value~     of the meal.~   "
32983|NCT02625337|"~     This is a Phase 2 trial consisting of 24 patients receiving the combination of dabrafenib +~     trametinib + pembrolizumab in 3 different dosing schemes and 8 patients receiving~     pembrolizumab standard monotherapy. All patients start with pembrolizumab standard therapy~     for 6 weeks and will then be randomized to continue pembrolizumab monotherapy or to receive~     additional intermitted/short-term dabrafenib + trametinib.~      Stratification will be baseline LDH level and baseline PD-L1 expression.~   "
32984|NCT02625324|"~     The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and~     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending~     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair. The Valiant Evo~     International Clinical Trial is a first-in human experience with the objective to provide~     clinical data for supporting CE marking via case series and descriptive statistics.~   "
32985|NCT02625311|"~     Randomized clinical trial comparing minimal invasive operating technique to conventional~     operating technique for placement of total knee prosthesis.~      Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these~     two techniques.~   "
32986|NCT02625298|"~     Traumatic tooth injuries are common in children and adolescents, and often result in pulpal~     necrosis and the development of periapical lesions. Treatment of traumatized teeth with~     endodontic complications depends on the type of injury, number of injured teeth, root~     development and patient cooperation, which altogether will create a challenge and dictate~     the treatment plan for the dentist. The purpose of this study was to assess the~     effectiveness of non-surgical root canal procedures in traumatized permanent teeth with~     necrotic pulps and chronic periapical lesions using a tri-antibiotic paste and~     calcium-hydroxide as intracanal medications and two different mineral trioxide aggregate~     (MTA) products for definitive obturation.~   "
32987|NCT02625285|"~     This is a laboratory research to evaluate performances of quantitative POC G6PD tests~     (Biosensors) against gold standard quantitative laboratory based tests and genotyping.~   "
32988|NCT02625272|"~     The purpose of this study was to determine the short and long outcomes of the novel~     hand-assisted laparoscopic (HLA) right hemicolectomy with complete mesocolic excision (CME)~     and no touch isolation.~   "
32989|NCT02625259|"~     The purpose of this study is to evaluate the relative bioavailability of a new tablet~     formulation of MLN1117 (NTM) compared to the MLN1117 Process B capsules (CTM) (Part 1), to~     assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of MLN1117~     (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of MLN1117 in~     healthy participants (Part 3).~   "
32991|NCT02625233|"~     This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked~     clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly~     replacement contact lens (control). Each subject will be assigned randomly to either the~     test or control lens to evaluate the long term safety and efficacy of the investigational~     contact lens compared to the marketed contact lens over a period of six months of lens wear.~   "
32992|NCT02625207|"~     This will be an open-label, parallel group, multiple dose study in approximately 48 healthy~     male or female subjects of African American and Caucasian self-reported race, to assess the~     effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and~     CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians~     in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).~   "
32993|NCT02625194|"~     This study investigate the utility of continuous oxygen insufflation during fiberoptic~     bronchoscope-guided intubation.~      One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.~      The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.~      Then, the velocity of deoxygenation difference of PaO2(baseline~   "
32994|NCT02625181|"~     The purpose of this study is to determine how automated recommendations are best presented~     to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after~     surgery.~   "
32995|NCT02625168|"~     The investigators prospectively evaluated in this study the efficacy and safety profiles of~     afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and~     first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program~     (CUP), with comparison of our historical cohort who received erlotinib after previous~     failure to systemic chemotherapy and first-generation EGFR-TKI.~   "
32996|NCT02625155|"~     The purpose of this study is to determine whether the addition of selective pharmacogenomic~     (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced~     by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following~     enrollment.~   "
32997|NCT02625142|"~     The goal of this study is to develop, implement, and evaluate the effectiveness of an~     intervention designed to facilitate family engagement during bedside rounds at a children's~     hospital. The intervention consists of a checklist of key behaviors associated with the~     delivery of quality family-centered rounds, as well as training in the use of the checklist~     tool. In a pre-post controlled design, two hospital services will be randomized to use the~     checklist while two others will be randomized to usual care. The intervention is expected to~     increase to the performance of key checklist behaviors, family engagement, and family~     perceptions of patient safety.~   "
32998|NCT02625129|"~     This study will evaluate the clinical effectiveness of, and patient satisfaction with,~     pre-travel consultations provided by a pharmacist with specialty training in travel medicine~     and the authorization to prescribe medications and administer vaccinations.~   "
32999|NCT02625116|"~     The objective of the ELENA French Cohort is to study the developmental trajectories of~     children and adolescents with ASD and their risk or protective associated factors.~      This is an open, prospective and multicenter cohort study, including children and~     adolescents under 16 years of age with ASD recruited from services specialized in the~     assessment of developmental disorders.~   "
33000|NCT02625103|"~     The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been~     debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.~      The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine~     within the range of 10-14 hours after the last administration of clozapine .~   "
33001|NCT02625090|"~     The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy~     during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant~     focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be~     explored.~   "
33002|NCT02625077|"~     This monocenter randomized controlled trial aims to compare postoperative outcomes of a~     laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum~     hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be~     done in order to determine cost-effectiveness and costs per quality-adjusted life-year~     (QALY).~   "
33003|NCT02625064|"~     The goal of this project is to find a series novel biomarkers by differential proteomic~     techniques that can improve the early diagnosis and develop a more efficient therapy to~     enhance ARDS patient survival rate.~   "
33004|NCT02625051|"~     This is a prospective randomized study, comparing quality of life in renal stone patients~     undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy~     (PNL).~   "
33005|NCT02625038|"~     Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies~     that are performed with patient-specific instruments.~      Due to the higher accuracy achieved it is expected that complaints can be resolved or~     effectively revealed. The Research hypothesis to prove is The medical product permits the~     surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus,~     carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and~     2º. Secondary outcome is an assessment of the surgical outcome using the Disabilities of~     the Arm, Shoulder and Hand (DASH) and the Patient related wrist Evaluation (PRWE) scores.~   "
33006|NCT02625025|"~     During laparoscopy pneumoperitoneum creates the necessary space in which to perform the~     operation. Growing evidence in general surgery has shown that reduction of intra-abdominal~     pressure during laparoscopy is related to improved postoperative outcomes, decreased pain~     perception, length of hospital stay, and analgesic rescue dosage in patients undergoing~     minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with~     standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and~     feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal~     pathologies.~   "
33064|NCT02624258|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen~     receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains (referred to~     as RNA CART19) in Hodgkin Lymphoma (HL) patients. Subjects will be treated with IV~     administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks.~   "
33007|NCT02625012|"~     Vitiligo is the most common acquired depigmented disorder of the skin characterized by~     destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet~     phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because~     it is able to induce proliferation, differentiation, maturation and migration of~     melanocytes. This repigmentation has distinctive patterns such as follicular, marginal, and~     diffuse. The aim of this study is to observe the dynamics of migration and proliferation, in~     vitiligo patients under UVB radiation phototherapy treatment. The investigators will~     evaluate this process by measuring FAK (focal adhesion kinase ) and c-Kit by~     immunohistochemistry and reverse transcriptase polymerase chain reaction assay.~   "
33008|NCT02624999|"~     Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine~     (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .~   "
33009|NCT02624986|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in~     combination with obinutuzumab in participants with relapsed or refractory FL or DLBCL.~     Participants with FL who achieve complete response (CR), partial response (PR), or stable~     disease (SD) at the end of induction therapy (EOI) will be eligible for post-induction~     treatment with obinutuzumab.~   "
33010|NCT02624973|"~     Breast cancer is an optimal model disease for studying personalized medicine. Breast~     cancer was the first malignancy for which a predictive factor forecasting response to~     therapy was identified nearly 50 years ago; the expression of the estrogen receptor (ER).~     Furthermore, breast cancer is by far the malignancy in which prognostic and predictive~     factors have been most extensively studied. Primary medical treatment (pre-surgical medical~     therapy) offers a unique setting to explore predictive factors due to the fact that primary~     breast cancers are easily accessible to repeated tissue sampling and evaluation of therapy~     response both clinically and radiologically. For many years, the investigators have studied~     predictive factors in primary medical treatment of breast cancer. In the present project,~     the investigators will implement a new trial concept where the current knowledge from~     previous trials with respect to predictive markers (hormone receptors, HER2; TP53, CHEK2 and~     RB1), will be combined with massive parallel sequencing (MPS). Thereby, the investigators~     aim to design the next-generation primary medical treatment where 1) therapy regimens are~     individualized based on a limited number of known predictive factors and, 2) MPS is used to~     explore additional predictive factors and their co-regulators in order to fully identify the~     mechanisms of drug sensitivity / resistance across individual tumours and pave the way for~     further personalized breast cancer therapy in the future. As for the new era of genomic~     medicine, the current trial concept will allow individual tumours to be characterized by~     their unique gene mutation / epigenetic modification profile upfront, to allocate patients~     to their optimal personalized medicine as compared to classical drug testing through phase~     II/III trials.~   "
33011|NCT02624960|"~     This is a single-arm, multi-center, open-label controlled study that will assess the safety~     and performance of the Accucinch System to induce left ventricular reverse remodeling and~     reduce the severity of functional mitral regurgitation in symptomatic adult patients with~     mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic~     or non-ischemic etiology), who are of high operative risk.~   "
33012|NCT02624947|"~     The purpose of this study is to determine the efficacy of maternal immunization with the RSV~     F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia~     through the first 90 days of life in infants.~   "
33013|NCT02624934|"~     Aortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis~     leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to~     heart failure at varying degrees of severity of aortic stenosis in individual patients. The~     predicting factors for the occurrence of a maladaptive response are not well defined.~     Therefore current medical therapy for aortic stenosis is considered insufficient and may~     actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is~     aortic valve replacement. It has been found in an experimental study that Podocan determines~     the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The~     possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also~     recently gained attention. This project will attempt to establish the prognostic role of~     circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic~     stenosis. This may help identify patients at particular risk to develop left ventricular~     dysfunction with aortic stenosis and improve understanding of the mechanisms of left~     ventricular remodeling in aortic stenosis. Hence, this may also later act as an important~     background in finding more effective therapies to prevent or delay maladaptive left~     ventricular response in aortic stenosis.~   "
33014|NCT02624921|"~     The study aimed to explore therapeutic effects of natural environments. To do so, the~     investigators evaluated the immediate and sustained changes in several indicators of~     well-being while people (n=26) with poor mental health were engaged in unconstrained~     exposures to natural (green, blue) and urban environments. The indicators included:~     affection, cognition, physiological responses.~      Each participant was exposed to all environments for a period of 210 minutes between October~     2013 and January 2014. During the exposure period, participants were instructed to do what~     they would usually do in that environment. Before, during (at 30 and 210 minutes) and after~     each exposure, several psycho-physiological measures were taken: (i) heart rate variability~     and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure~     monitor, (iii) physical activity using the CalFIT application installed in a Smartphone,~     (iv) lung function using a portable computerized spirometer, (v) stress level using salivary~     cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social~     interactions using questionnaires, (vii) cognitive functioning using the backwards~     digit-span task test.~   "
33015|NCT02624908|"~     24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy~     of canagliflozin as compared with placebo in reducing the need for mealtime insulin in~     subjects with type 2 diabetes currently using a basal-bolus insulin regimen.~   "
33065|NCT02624245|"~     Assess pain, performance function, hip and knee strength and kinematics of trunk and lower~     limbs during single leg hop test after movement control training associated to hip and knee~     muscle strengthening.~   "
33016|NCT02624895|"~     This is a national, multicentric, prospective, observational trial. The decision to~     prescribe FOLFOX plus panitumumab or FOLFOX plus cetuximab must have been freely taken by~     the clinician prior to the study entry for each patient included. Each physician will see~     his/her patients within the context of routine visits, without any special visit being~     organised for the purposes of the study. Therefore, the doctor-patient relationship and~     patient follow-up are not modified. Physicians are totally free to decide on their patients'~     therapeutic management.~      EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1~     of Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at end~     of treatment visit (28 days (+/- 3 days) from the last cycle). Questionnaires should be~     completed at the start of the visit, before any study related procedure is done.~      Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0.~     Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions~     will be recorded.~      Concomitant approaches to prevent or treat dermatological toxicities during the treatment~     will be registered.~   "
33017|NCT02624882|"~     Single-center prospective study to assess the clinical course of group A streptococcal~     blistering distal dactylitis in children after antibiotic treatment.~   "
33018|NCT02624869|"~     To describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab (AMG~     145) when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or~     HoFH.~   "
33019|NCT02624856|"~     The purpose of this study is to compare the efficacy and duration of pain relief after total~     knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus~     standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps~     sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal~     bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to~     discharge readiness.~   "
33020|NCT02624843|"~     To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5%~     with Ulesfia Lotion 5% in eradication of head lice in the study subjects.~   "
33021|NCT02624830|"~     The purpose of this study is to investigate long term response of sulfonylurea and glucose~     control in children with diabetes due to mutations in ABCC8 that have been switched from~     insulin injections to sulfonylurea tablets.~   "
33022|NCT02624817|"~     The purpose of this study is to investigate long term response of sulfonylurea and glucose~     control in children with diabetes due to mutations in KCNJ11 that have been switched from~     insulin injections to sulfonylurea tablets.~   "
33023|NCT02624804|"~     This is a prospective, single arm, open-label, single-center pilot study to assess the~     safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of~     patients with Type 1 Diabetes.~   "
33024|NCT02624791|"~     Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with~     respect to driving is unknown, but it could threaten safe operation of a motor vehicle,~     especially under conditions such as nighttime driving when visual abilities are highly~     challenged. This study measures driving-specific visual abilities and simulated driving~     performance in participants with astigmatism who either have or do not have their~     astigmatism corrected. The primary hypothesis is that at a tactical level, contact lenses~     correcting for astigmatism will result in safer driving performance overall. The secondary~     hypothesis is that at an operational level, contact lenses correcting for astigmatism will~     result in better driving-specific visual performance.~   "
33025|NCT02624778|"~     The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the~     safety of LY3002813 by looking at adverse events (side effects). The study will also look at~     the effect the body has on LY3002813. Study participants will have mild cognitive impairment~     (MCI) due to AD or mild to moderate AD.~      The study involves 3 parts.~        -  Part A in which participants will receive a single dose of LY3002813 or placebo (no~          drug).~        -  Part B in which participants will receive multiple doses of LY3002813 or placebo for 24~          weeks.~        -  Part C in which participants will receive multiple doses of LY3002813 or placebo for up~          to 72 weeks.~      Drug will be given as an injection into a vein. For Parts A, B and C, the study will last~     approximately 72 weeks, not including screening of approximately 42 days. The study is for~     research purposes only and is not intended to treat any medical condition.~   "
33026|NCT02624765|"~     Few studies are specifically designed to address health concerns relevant during pregnancy.~     The consequence is a lack of evidence on best clinical practice. This includes mothers and~     their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats~     per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus).~     Although fetal SVA, including atrial flutter (AF) and other forms of supraventricular~     tachycardia (SVT), is the most common cause of intended in-utero fetal therapy, none of the~     medication used to date has been evaluated for their effects on the mother and her baby in a~     randomized controlled trial (RCT). As a consequence, physicians need to make decisions about~     the management of such pregnancies without any evidence from controlled trials on drug~     efficacy and safety and no consensus among specialists for the optimal management. The Fetal~     Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective~     multi-center trial that addresses this knowledge gap to guide future fetal SVA therapy to~     the best of care. Study components of FAST include three prospective sub-studies to~     determine the efficacy and safety of commonly used transplacental drug regimens in~     suppressing fetal AF without hydrops (RCT A), SVT without hydrops (RCT B), and SVT with~     hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy,~     which either is started as monotherapy (no hydrops) or as dual therapy (hydrops). The~     primary study aim is the probability of a normal pregnancy outcome after treatment start~     with Digoxin or Sotalol (AF without hydrops); Digoxin or Flecainide (SVT without hydrops);~     and Digoxin plus Sotalol or Digoxin plus Flecainide (SVT with hydrops). The study also~     includes the possibility to enroll non-randomized subjects into a prospective Registry to~     document the outcome of alternative management.~   "
33027|NCT02624752|"~     The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral~     Nutritional Supplement (ONS) on physical function and functional performance in malnourished~     elderly patients.~   "
33028|NCT02624726|"~     Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II~     trial of patients with metastatic colorectal cancer. The promising results of aflibercept~     derived from preclinical studies and from clinical trials conducted in patients with~     refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open~     the field to explore such therapeutic approaches in the 1st line setting in combination with~     the FOLFIRI regimen.~   "
33390|NCT02620007|"~     The primary objective of this trial is to assess whether a 12-week treatment with~     Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in~     adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or~     without involvement of the caecum or the right colon.~   "
33029|NCT02624713|"~     Randomized Clinical Trial, the research will be composed of two parts in order to examine~     the research question: a combination of controlled randomized retrospective research and~     prospective cohort research~      Prospective Cohort Research:~      The research groups - families coming for treatment in Active Maccabi clinics in the~     Northern Region, Israel. Approximately 30 families.~      Retrospective Random Controlled Research~        1. The research group - families that have completed an intervention program of Active~          Maccabi Northern Region, Israel,within the past two to three years. The families will~          be requested to attend a follow-up meeting of all family members in which they will~          answer questionnaires. Approximately 66 families.~        2. The control groups - families who did not participate in the program who have a child~          between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in~          correlation with the child in the intervention group. Approximately 66 families.~      Hypotheses of the research:~        1. Status of the weight of the child being treated and of his siblings will be higher than~          that at the end of the program.~        2. Indication of the obesogenic environment of families participating in the program will~          be lower in comparison with families not participating in the program.~        3. The rate of eating disorder symptoms among children who participated in the program~          will be lower in comparison with those of the obese/overweight child in families who~          were not the program.~        4. The rate of eating disorder symptoms among siblings who participated in the program~          will be lower than that of siblings in families not in the program.~   "
33030|NCT02624700|"~     This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and~     sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC).~     Candidate pharmacodynamic and predictive biomarkers will also be evaluated.~   "
33031|NCT02624687|"~     This study will test the effects of a sedentary behavior intervention on low back pain in~     working adults. The behavioral intervention will include the use of a sit-stand desk and a~     wrist-worn activity prompter that will notify participants when they have been sedentary for~     too long.~   "
33032|NCT02624674|"~     Peripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in~     the compromised tissue perfusion of lower limbs. PAD patients can experience pain,~     diminished exercise capacity, and tissue loss, with some ultimately requiring amputation.~     The economic burden of PVD is significant. In the United States alone, PVD accounts for over~     $20 billion in annual healthcare related costs.~      The demand for the development of an effective method to characterize the viability of PVD~     wounds has resulted in the emergence of several innovative techniques. Commonly used~     diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex~     ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe~     pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging.~     Currently, angiography remains the diagnostic gold standard. However, many of these~     techniques lack the ability to triage and adequately determine the viability of the wound.~     In addition, there remains a need for effective triage technologies to help clinicians~     decide whether surgical management is needed. Early determination of surgical versus~     conservative management may help to improve patient functional outcomes, reduce mortality~     rates, and prevent limb amputation.~      Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent~     applications in PVD wound assessment. To date, studies have demonstrated the validity of~     NIRS technology in patients with peripheral arterial disease. NIRS measures flow,~     concentration, and oxygenation of hemoglobin in arterioles, capillaries, and venules several~     centimeters deep in tissue. The MSID is an evolution of existing NIRS imaging devices and~     has become a portable and functional commercial device produced by KENT imaging (Calgary,~     Canada). Using this new and clinically applicable NIRS technology designed for assessing~     wound perfusion and oxygenation, this study seeks to adequately identify viable from~     non-viable wounds and to rapidly determine indication for vascular interventions. This~     technology is well-suited for use in a wound patient population as the measurements times~     are short and can quickly be used at the patient bed side. As such, this project intends to~     apply NIR technology to quickly assess PVD in the investigators' patient population.~   "
33033|NCT02624661|"~     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not~     have enough effect with the available pharmaceutical treatments and are offered a type of~     surgery, which involves the injection of glycerol in a nerve structure called trigeminal~     ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique~     using neuronavigation. The researchers believe that this new neuronavigation-based system~     can improve the precision of the technique and reduce the risk for complications.~   "
33034|NCT02624648|"~     Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal~     women.~      Method: It will be held a clinical, prospective, randomized, double-blind,~     placebo-controlled study with 144 postmenopausal women with sexual dysfunction, treated at~     Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the~     Vale do Sapucai University. All women sign the Consent Form Term. The study will be~     conducted in accordance with the protocol and principles of the Declaration Helsinki~     (Version 1996), according to International Conference on Harmonization and Tripartite~     Guidelines for good clinical practice and regulatory requirements. The protocol was approved~     by the Ethics Committee of the Faculty of Medical Sciences of Santa Casa de São Paulo.~      Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.~   "
33035|NCT02624635|"~     The purpose of this study is to compare the effects of manual therapy and of manual therapy~     associated with hip strengthening in the recovery of patients with heel pain.~      Heel pain decreases function, balance, walking and can cause change in the movement pattern.~     This alterations can induce a deficit in motor control of other structures as knee and hip.~     There is an importance to compare the effects of manual therapy and manual therapy~     associated with hip strengthening on the recover of patients with heel pain.~   "
33036|NCT02624622|"~     Studies in several countries with a high rate of death of infants during the first week of~     life have found a reduction in infection and mortality when chlorhexidine is applied to the~     umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate~     if providing chlorhexidine to pregnant women during a prenatal care visit for application to~     the cord stump after birth will be as effective for preventing omphalitis (infection of the~     umbilical cord stump) as sending a community health worker into the home to apply the~     chlorhexidine.~   "
33128|NCT02623426|"~     The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will~     compare the relative efficacy and safety of intravitreal methotrexate, intravitreal~     ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular~     edema persisting after an intravitreal corticosteroid injection. MERIT is a parallel design~     (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic~     visit. The primary outcome is percent change in central subfield thickness from the baseline~     OCT measurement to the 12 week visit.~   "
33037|NCT02624609|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak~     concentration usually after 30 minutes. When the body senses the increase in blood glucose,~     a hormonal process involving insulin takes place to ensure that the glucose is taken up from~     the blood for storage and where it is needed for energy in the body. This process then~     brings about a decrease in the concentration of glucose until it reaches approximately the~     starting concentration. The original concentration of glucose is attained approximately 2~     hours after eating or drinking a carbohydrate food or sugary drink respectively in healthy~     people.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.~      Research has shown that diets that give rise to a high glucose response are associated with~     a number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome~     mostly comprises of insulin resistance and glucose intolerance which gives an increased risk~     of type 2 diabetes. It also gives rise to other conditions like high blood pressure~     (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts~     of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood~     (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular~     disease also rises. Research has also shown that foods/drinks which raise blood glucose~     levels gradually (low GI) rather than rapidly (high GI) have health benefits which include~     reducing the risk of metabolic syndrome. Laboratory studies have shown that polyphenols~     found in fruits, vegetables and plant based foods have a positive effect on carbohydrate~     metabolism and can lower the blood glucose levels.~      This research will determine whether the presence of polyphenols in the diet has any~     lowering effect on the blood glucose levels and hence the glycaemic index of foods. This~     will be determined by asking volunteers to consume commercially available food supplements~     together with white bread and then determining the glycaemic response. The blood glucose~     response of bread will be determined initially as a control reference. All will be consumed~     in random order.~      Analysis will be done by measuring blood glucose response after consumption of the control~     reference meal and the test meal containing polyphenols and then determining the incremental~     area under the glucose curve.~   "
33038|NCT02624596|"~     The purpose of this study is to understand how ketamine brings about rapid improvement in~     Obsessive-Compulsive Disorder (OCD) symptoms.~   "
33039|NCT02624583|"~     Ramadan fasting (RF) has been shown to be associated with vascular and metabolic disorders~     including glycemic control and lipid profile. It may also alter pharmacologic properties of~     some medications. Many patients with CAD and under Clopidogrel insist to observe the fasting~     and taking the risk of altering the pharmacologic proprieties of this drug.~      The aim of this study is to assess the effects of RF on clopidogrel resistance in patients~     at high cardiovascular risk with particular interest to patients with DM.~   "
33040|NCT02624570|"~     The purpose of this study is to provide access to Midostaurin and gather additional safety~     data on the combination of Midostaurin and standard of care for adult patients with newly~     diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who~     are eligible for standard induction and consolidation chemotherapy.~   "
33041|NCT02624557|"~     To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic~     impairment compared to matched healthy control subjects.~   "
33042|NCT02624544|"~     Proton pump inhibitors act in blocking acid secretion and also have antioxidant and~     anti-inflammatory properties. For that mechanisms possibly PPIs may have an~     anti-inflammatory action with improvement in skin lesions in patients with psoriasis.~   "
33043|NCT02624531|"~     Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function~     will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal~     lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma. Three~     cycles of neoadjuvant chemotherapy (NACT) will be administrated and then different~     fertility-sparing surgery(conization,simple trachelectomy or radical trachelectomy +~     sentinel node biopsy) will be employed depending on the tumor size.~   "
33044|NCT02624518|"~     This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide~     receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic~     resonance imaging (MRI) works in detecting prostate cancer in patients with negative~     computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment~     with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and~     combine them into a single picture and is used to describe information regarding the~     function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a~     radioactive agent linked to a pharmacological substance that is strongly attracted by a~     substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to~     see smaller tumors than the standard of care contrast-enhanced CT or MRI scan~   "
33045|NCT02624505|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product, using bronchoprovocation (methacholine challenge testing)~     in adult patients with stable mild asthma.~   "
33046|NCT02624492|"~     The main objectives are to establish the MTD of BI836826 -GemOx and thereafter to compare~     the efficacy as Overall response (OR) based on the central review assessments of BI 836826-~     GemOx and R-GemOx in patients with relapsed DLBCL. The secondary objectives are to evaluate~     the pharmacokinetics of BI 836826 in combination with GemOx and to investigate and compare~     the efficacy as CR by way of central review assessments for BI 836-GemOx and R-GemOx in~     patients with relapsed DLBCL.~   "
33047|NCT02624479|"~     Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of~     renal calculi could be a future indication for sodium thiosulfate (STS). Using an oral~     formulation might increase the compliance and treatment success compared to parenteral~     administration.~      Three gastro-resistant formulations of STS for oral administration were developed with~     different release characteristics: fast-release, medium-release and slow-release tablets.~     Aim of the enteric coating was to increase the oral bioavailability of STS. The~     bioavailability and tolerability of these formulations for oral administration in healthy~     volunteers will be compared in this clinical trial.~   "
33078|NCT02624076|"~     Infertility affects one in six couples. In a quarter of them, routine tests of semen~     quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of~     infertility is unexplained. Acupuncture is being increasingly used by couples with all types~     of infertility and initial trials have suggested that it could be potentially beneficial in~     some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting~     results, but there is no evidence to inform best practice in unexplained infertility. In~     addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits~     for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could~     have the potential to increase live birth rates in women with unexplained infertility, the~     clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a~     large randomized controlled trial.~   "
33079|NCT02624063|"~     The purpose of the study is to study the combination of Sofosbuvir in Combination With~     Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic~     Hepatitis C Virus (HCV) Genotype 1.~   "
33048|NCT02624466|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide~     the clinician with new diagnostic and therapeutic tools for the management of children with~     CKD, based on the improved understanding of uraemic toxicity.~      In this first part of UToPaed, the investigators will associate concentrations of a wide~     variety of uraemic toxins with different comorbidities in CKD children, i.e. growth,~     protein-energy wasting, quality of life, cardiovascular risk factors, circadian rhythm,~     sleep quality, and psychosocial and neurocognitive functioning (i.e. cross-sectional and~     longitudinal). The toxins of which concentrations are best correlated with comorbidities~     during the progress of CKD and eventually have representative kinetics (UToPaed - part 2:~     Kinetic analysis) will be selected as markers. These markers will be, together with the~     comorbidities, further tracked after interventions, i.e. starting on dialysis,~     transplantation, changes in dialysis strategy (UToPaed - part 3 - intervention study).~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of~     all children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
33049|NCT02624453|"~     The aim of the study is to evaluate systematic pre-antiretroviral cryptococcal antigen~     screening and pre-emptive fluconazole therapy in antigen positive patients, as a strategy to~     reduce morbidity and mortality due to AIDS associated cryptococcal meningitis in patients~     starting antiretroviral therapy at <100 CD4 in Cameroon.~   "
33050|NCT02624440|"~     This study evaluates the effect of prophylactic antibiotics in multiple myeloma. One third~     of patients will received treatment with clarithromycin, one third of patients will receive~     treatment with sulfamethoxazole/trimethoprim and one third will be observed without~     prophylactic antibiotics. All patients receive concurrent anti-myeloma treatment.~   "
33051|NCT02624427|"~     The aim of the study is to approach the true Intra ocular pressure (IOP) by correlating~     the difference between IOP by Goldmann Applanation Tonometry to the IOP by Dynamic Contour~     Tonometry to the biomechanical parameters of the cornea measured by Corvis ST. Therefore the~     investigators gain new findings about the influence of the biomechanical corneal parameters~     on the IOP. In order to do so the investigators want to examine 50 Glaucoma eyes and 50~     non-Glaucoma Eyes with Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis~     ST.~   "
33052|NCT02624414|"~     Aims:~        -  To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).~        -  To compare the results of capsule colonoscopy with conventional colonoscopy in~          assessing mucosal healing.~        -  To correlate the level of faecal calprotectin with the results of capsule colonoscopy~          and conventional colonoscopy.~        -  To document changes in clinical practice attributable to the capsule colonoscopy~          findings a) concordant with and b) in addition to the parallel findings at colonoscopy~          and ileoscopy.~      Project design: Cross sectional, prospective, comparative study~      Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality~     clinics with an established diagnosis of CD who need assessment of mucosal healing and have~     consented to be part of the study will undergo capsule colonoscopy and conventional~     colonoscopy on the same day after undergoing bowel preparation. The images of both the~     conventional and capsule colonoscopies will be recorded. In addition calprotectin (an~     inflammatory marker in faeces) will be measured in a sample of faeces collected by the~     patients prior to the colonoscopy day.~      Professor Macrae and the scholarly selective student researcher will assess the recorded~     images obtained from capsule colonoscopies once the images have been deidentified.~      To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD~     (SESCD).~      The results of the assessment of mucosal healing obtained from conventional colonoscopy will~     be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be~     correlated.~   "
33053|NCT02624401|"~     Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and~     electroencephalography (EEG) studies will be carried out to reveal the neural correlates of~     consciousness. Consciousness of the subjects will be manipulated with anesthetic agents~     dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy~     male subjects will be recruited to receive EC50 concentration of the anesthetic (40~     dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being~     imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and~     metabolomics samples will be taken and analysed to find possible genetic factors explaining~     the variability in drug response and to find chemical fingerprints of acute drug effect.~   "
33054|NCT02624388|"~     Toxicities related to pediatric cancer treatment can lead to significant illness, organ~     damage, treatment delays, increased health care cost, and decrease in quality of life. Such~     toxicities are largely due to tissue damage sustained by chemotherapy, and strategies~     designed to limit such cellular damage to normal tissues may reduce therapy-related~     morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects,~     naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and~     have been shown to reduce side effects of therapy in adult oncology clinical trials. This~     study will examine the effect of genistein, the major isoflavone component in soybeans and~     the most extensively studied of the soy isoflavones, on short-term side effects of~     myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to~     receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo~     during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2~     and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that~     subjects will have fewer short-term therapy-related side effects during cycles of~     chemotherapy given in conjunction with genistein supplementation than cycles given with~     placebo.~   "
33055|NCT02624375|"~     The purpose of this study is to learn more about the immune response to varicella zoster~     virus (VZV).~   "
33056|NCT02624362|"~     An extended replication of Jaen & Dalton (2014), the investigators aim to investigate the~     role of odors and associated trigger beliefs on symptom perception and airway inflammation~     in individuals with asthma~   "
33057|NCT02624349|"~     The human papilloma virus (HPV) is known to be an important cause of cervical and anal~     cancers. Studies on patients who have received a solid organ transplant (such as a liver or~     kidney transplant) have suggested the risk of HPV-related cancers may be higher in this~     population. The HPV vaccine, Gardasil®, has been approved for use in males and females by~     Health Canada. In studies on healthy subjects this vaccine is nearly 100% effective at~     preventing infections from HPV serotypes that are in the vaccine. These serotypes,~     representing different viral strains, are known to cause 70% of cervical cancers and 90% of~     genital warts. The vaccine was also shown to be very safe and well tolerated in healthy~     subjects. Transplant patients are at higher risk of HPV related complications and cancers.~     As a result transplant experts have recommended this vaccine for use in their patients;~     however there have been no studies looking at the response to vaccination or safety of this~     vaccine in solid organ transplant recipients. Our objective is to study the immune response~     and side effects of Gardasil® in children who have received kidney or liver transplants. We~     will study this by comparing immune responses to the vaccine in healthy adolescent females~     compared to female liver and kidney transplant recipients. We will be recruiting females~     ages 12-19, as the province of Ontario funds the vaccine for this group. We will evaluate~     the transplant subjects for side effects after they receive the vaccine. Our hypothesis is~     that transplant recipients will have lower immunogenicity than healthy controls.~   "
33058|NCT02624336|"~     Accumulation of dental plaque may result in negative effects on the tooth and tooth~     supporting periodontal tissue. In addition, it contributes to the development of caries and~     periodontal diseases. Therefore, an effective dental plaque control is essential for~     maintaining good oral hygiene. Mechanical plaque control has its limitation thus chemical~     plaque control may be used as an adjunct in dental plaque control. Various types of~     medicinal plants can be utilized as stable, safe and biologically active plant-derived~     galenicals as alternative to synthetic mouth wash. Among these plants, Salvadora persica L.~     (Sp) root sticks and green tea (Gt) aqueous extracts were reported to have anti-microbial~     activity against many oral bacteria. The objective of this study was to investigate the~     efficacy of the combination of Gt aqueous extract and Sp aqueous extract as a synergistic~     anti-bacterial and anti-adherence efficacy against primary plaque colonizers.~   "
33059|NCT02624323|"~     The main intention of this study is to compare two ultrasound-guided central venous~     catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein~     catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization~     in terms of venipuncture, catheterization success, early mechanical complication and~     catheter-related infection rate in mechanically ventilated patients admitted to the~     intensive care unit.~   "
33060|NCT02624310|"~     The aim of this study is to increase norepinephrine levels in a population of young adults~     where NE levels are very low or undetectable. In order to achieve this, the optimal dose~     will be determined in a titration step. In the titration step, different doses of L-DOPS~     will be tested in order to find the optimal and safest dose suitable for each individual~     enrolled in the study. Because L-DOPS has never been used in the US in children or young~     adults, with this titration step investigators will also determine the safest dose for this~     population.~      Currently, L-DOPS is being used in our center to treat othostatic hypotension in autonomic~     failure. The titration step for this study starts with the dose of 100 mg and increases in~     an escalating manner up to a maximum of 600 mg a day (see investigational brochure~     attached).~      L-DOPS has been developed in capsules for oral used and all the previous safety data has~     been performed using this route. Oral route is the one that will used during study.~      Carbidopa is well tolerated, safe in children and it has been used in this population in the~     US without severe adverse effects.~   "
33061|NCT02624297|"~     The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity~     (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD)~     patients and that the presence of obstructive sleep apnea (OSA) will potentiate these~     responses. And, that the exercise training would decrease the chemoreflex response of MSNA~     in these patients.~   "
33062|NCT02624284|"~     Behaviors such as tobacco use, unhealthy diet, and sedentary behavior have far-reaching~     health implications. These modifiable behaviors account for a substantial proportion of~     deaths from cancer, cardiovascular disease and diabetes, and take a significant economic~     toll. Yet, many unhealthy behaviors are very resistant to change, despite widespread~     knowledge of the risks. Although theories of behavior change have been advanced to explain~     the persistence of these behaviors, few consider the neurobehavioral underpinnings. These~     approaches also fail to address a fundamental aspect of behavior change - an individual's~     ability to exert sufficient self-control to overcome temptations for immediate gratification~     and/or to maintain attention to long-term goals. With advances in the neuroimaging field,~     the investigators are learning where and how self-control over decisions and behaviors is~     executed in the brain. This work points to the central role of neural activity in the~     dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to~     healthy choices. Further, emerging evidence shows that activity in the prefrontal cortices~     and cognitive control circuits can be modulated using a noninvasive and safe intervention:~     direct current transcranial stimulation (tDCS). The investigators pilot study, IRB study~     #820231, demonstrated that a single session of 1mA tDCS increased the ability to resist~     smoking in a validated smoking lapse paradigm. The current study will use a between-subject~     design to investigate the dose/response relationship between tDCS (administered at 1mA, 2mA,~     or sham stimulation for three sessions) and ability to resist smoking.~   "
33063|NCT02624271|"~     Despite the declining incidence, gastric cancer (GC) remains the second leading cause of~     cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases~     per year. It is now well demonstrated that patients with H. pylori infection, atrophic~     gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore~     important to detect these pre-neoplastic lesions at an early stage to improve patients~     prognosis.~      Thus, the aim of this project is to investigate the possible screening of gastric~     precancerous lesions by a blood test (GastroPanel®) in France, in patients with~     oesophagogastroduodenoscopy (EGD) prescription.~   "
33080|NCT02624050|"~     Patient undergoing general anesthesia in elective surgery will be assigned to receive either~     methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes~     of induction will be compared between the groups to ascertain which drug is less likely to~     cause a hypotensive event.~   "
33066|NCT02624232|"~     Background Anorectal malformations(ARM) are rare and cover congenital defective development~     of rectum.~      ARM include a range of congenital conditions and may in varying degrees involve the~     anorectum. A significant part have malformations in other organs mainly the urinary tract.~      In the vast majority ARM are recognized at birth by lack of a normal anus. The primary~     approach is construction of a stoma and subsequent reconstruction. Bowel continuity is~     typical restored after 4-6 months.~      Many patients experience abnormal bowel function later on and affected quality of life(QoL).~      Aim~      The primary objective is to assess the patient-related outcome 10-30 years after surgery for~     ARM and to see if it related to existing damage to anorectum and bowel function. The~     secondary objective is to identify problems with bowel function which may be treated~     medically or by surgery to improve bowel function and QoL. To obtain the necessary knowledge~     the study is divided in the following sub-projects:~        1. Assessment of bowel function and QoL through relevant questionnaires~        2. Examine sphincter anatomy and function through rectal ultrasound, magnetic~          resonans(MR)-scan of the pelvis and anal manometry. Bowel function is assessed through~          colonic transit time. Screening for urinary tract problems with uroflowmetry.~      Methods Participants are identified through relevant diagnostic codes(Q 42) and patients~     which underwent surgery for ARM in the years 1985-2005 are included if informed consent is~     obtained.~      Relevant questionnaires regarding symptoms and QoL are completed before the following~     examinations:~        -  Anal manometry~        -  Anal ultrasound~        -  Pudenda conduction velocity~        -  Colonic transit time~        -  Magnetic resonans(MR)-scan of lower abdomen and pelvis~        -  Uroflowmetry~      Bowel function and QoL is assessed in both children and adults with relevant validated~     questionnaires.~      Perspective No danish studies and only a few foreign investigate the relationship between~     anatomy/physiology and quality of life after surgery for anorectal malformations.~      The investigators believe the study and included comprehensive examinations will clarify the~     causes of functional problems after surgery for anorectal malformations. Results of~     questionnaires regarding symptoms, disease-specific-and general quality of life offer a~     unique opportunity for targeted treatment to improve symptoms and QoL in patients with ARM.~   "
33067|NCT02624219|"~     This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant~     females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility~     criteria. This clinical trial is designed to assess the safety, reactogenicity, and~     immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by~     bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or~     without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis~     Vaccines and Diagnostics, respectively.~   "
33068|NCT02624206|"~     This is an etiology study designed to examine the how people's brains and behaviors respond~     to regularly consuming a beverage. Participants are assessed at 2 behavioral assessments~     (Wave 1 and Wave 2), 2 scans (at the BRIC), and at 9 'intervention' assessments (5-10mins)~     different time periods throughout the study. At their first assessment (W1) they are~     randomized into one of two juices.~   "
33069|NCT02624193|"~     Preliminary data from the investigators' NCCAM-funded R21 on mindfulness-based stress~     reduction (MBSR) in HIV-infected youth suggest an association between mindfulness and~     improved self-regulation and medication adherence. This randomized, controlled trial will~     help the investigators to better understand the specific impact of MBSR on HIV medication~     and treatment adherence in HIV-infected youth, and the efficacy of MBSR in the amelioration~     of stress and improved self-regulation.~   "
33070|NCT02624180|"~     The investigators are studying whether an anti-inflammatory intervention improves impaired~     coronary endothelial function (CEF) in HIV+ people with subclinical coronary artery disease~     (CAD).~   "
33071|NCT02624167|"~     A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in~     patients with chronic schizophrenia that are not responding adequately to their current~     antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose~     range of 15 to 25 mg, BID in a 1:1 ratio.~   "
33072|NCT02624154|"~     Investigator determined the factor of surgery associated with the survival of pancreatic~     neuroendocrine tumor.~   "
33073|NCT02624141|"~     This study will examine the efficacy, safety, and effect on hemoglobin levels, of once~     weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic~     patients with solid tumors. The anticipated study duration is 4 months, and the target~     sample size is 40 individuals.~   "
33074|NCT02624128|"~     V-CHANCE is a phase 2, trial exploring the feasibility and the activity of valproic acid~     (VPA) in combination with the standard cisplatin-cetuximab combination in patients with~     recurrent/metastatic squamous cell carcinoma of the head and neck, never treated with~     first-line chemotherapy. The study includes an explorative analysis of the potential~     prognostic or predictive role of several biomarkers with the aim of improving the knowledge~     of the mechanisms by which VPA enhances chemotherapy effect and of identifying early~     predictors of treatment response/resistance.~   "
33075|NCT02624115|"~     Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Canada. Rectal~     cancers are now known to be hypoxic which is a negative prognostic factor and predictive of~     metastatic spread and poor responsiveness to treatment. This has also been shown in~     preclinical xenograft models. Hence there is a need for identification of hypoxic rectal~     cancers.~      In this pilot study the investigators intend to non-invasively assess the tumor and nodal~     metastasis using an integrated Positron Emission Tomography-Magnetic Resonance Imaging~     scanner (PET/MRI) with 18F-Fluoroazomycin Arabinoside (18F-FAZA) a radiopharmaceutical for~     assessing tumor hypoxia. The hypoxic rectal tumors will show an increased uptake of 18F-FAZA~     on PET which will have morphological correlation on MRI. The patient will then undergo~     neoadjuvant chemoradiation therapy (CRT) followed by repeat 18F-FAZA PET/MRI and rectal~     cancer surgery with pimonidazole staining. Pimonidazole is an extrinsic marker of hypoxia~     that is selectively reduced and covalently bound to intracellular macromolecules in areas of~     hypoxia within normal and tumor tissue with current approval for use in humans for research~     studies.~      The primary goal of this pilot trial is to validate FAZA-PET as a biomarker of hypoxia by~     correlating its uptake in rectal tumors to pimonidazole staining in histopathology~     specimens. If the investigators pilot study successfully demonstrates the uptake and~     correlation of pimonidazole and FAZA-PET, the investigators would like to initiate a larger~     study examining hypoxia in rectal cancer. The investigators aims would be to image patients~     with locally advanced rectal cancer before CRT to ascertain whether high FAZA-PET uptake~     correlates with poor outcome to CRT. The ability to preoperatively predict the patient~     sub-population that will respond best to CRT, will help to identify the complete~     pathological responders and avoid unnecessary surgery. Furthermore, the FAZA-PET high~     subset of patients may benefit from other treatment strategies including clinical trials of~     anti-hypoxic agents.~   "
33076|NCT02624102|"~     Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world.~     The treatments of choice are the psychotropic drugs of the class of antidepressants and~     Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the~     efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy~     in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,~   "
33077|NCT02624089|"~     The objective of this study is to assess whether the administration of nebulized~     intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline,~     reduces morphine consumption after laparoscopic appendectomy surgery in children and~     adolescents.~   "
33122|NCT02623504|"~     A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and~     safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label~     and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed~     with acute manic or mixed Bipolar I Disorder~   "
33081|NCT02624037|"~     The introduction of infliximab (IFX) and other monoclonal antibodies (MAbs) targeting tumor~     necrosis factor (TNF) was a major advancement in the management of inflammatory bowel~     disease (IBD). These biologics were able to improve the health outcomes of many IBD patients~     for whom other treatments were neither satisfactory nor sufficient. Despite clear advantages~     and increased use of these treatments, physicians still see a loss of response in up to 50%~     of their IBD patients within one year of initiating these therapies. Most of these phenomena~     are attributed to low drug concentrations in the presence or absence of anti-drug antibodies~     (ADA).~      The fundamental issue is that approved/on-label dosing of these drug therapies does not take~     into account the various factors that impact the way an individual's body responds and~     processes these therapies. Dashboard software systems can quickly integrate patient data and~     serve as a revolutionary decision-support tool for physicians. The Precision IFX dashboard~     prototype was specifically developed to facilitate dosing of therapeutic monoclonal~     antibodies by integrating patient's clinical characteristics and drug concentrations into~     pharmacokinetic (PK) algorithms. Using clinical observations and patient laboratories, the~     system provides multiple dosing regimens that could allow the patient to attain and sustain~     a therapeutic drug trough level.~      Using the Precision IFX dashboard to analyze and forecast optimal dosing regimens with~     prospectively collected individual patient data, the clinician will select an appropriate~     dose to actively maintain therapeutic drug trough levels throughout the infliximab~     maintenance period. This study aims to examine the outcomes of one year of maintenance~     infusions in IBD patients dosed using the Precision IFX dashboard prototype and compare the~     results with historical controls.~   "
33082|NCT02624024|"~     The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays~     intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and~     laboratory settings. The purpose of the study is to establish the clinical performance of~     the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use~     population.~   "
33083|NCT02624011|"~     This study will investigate the influence of increased sedentary time on long-term measures~     of muscle protein synthesis and metabolic health. The investigators will test the hypothesis~     that increased time spent in sedentary behaviours will lead to a reduction in long-term~     measures of muscle protein synthesis and compromised metabolic health.~   "
33084|NCT02623998|"~     The purpose of the study is to determine whether in patients with early type 2 diabetes,a~     short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal~     insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in~     achieving sustained diabetes remission.~   "
33085|NCT02623985|"~     The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic~     streptococci in patients who presented with sore throat at out patient department in Siriraj~     Hospital.~   "
33086|NCT02623972|"~     This research study is studying a drug called eribulin combined with standard treatment as a~     possible preoperative treatment for HER2 negative inflammatory breast cancer.~   "
33087|NCT02623959|"~     The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in~     combination with saline (the current standard of care) versus IPC in combination with~     doxycycline as treatment for pleural effusions.~   "
33088|NCT02623946|"~     Study Design:~      Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks~     apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's)~      MEP's will include:~        1. Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior~          muscles~        2. MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes~          (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles~          Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and~          every 6 months for 36 months.~      Study location: Single center in Canada~      Study Objectives:~      Primary: To evaluate the reliability of MEP's in Alemtuzumab treated MS patients over a 36~     month period.~      Secondary: To determine the degree of correlation between MEP's and presently used clinical~     measures of efficacy (EDSS, 6MWT, T25FWT, 9HPT) and to determine if MEP's can predict who~     will require a third cycle of Alemtuzumab.~   "
33089|NCT02623933|"~     Radiation therapy plays an important role in the management of prostate cancer. In recent~     years it has become evident that higher doses of radiation are required to optimize disease~     control. The limiting factor of escalating dose to the prostate is the surrounding normal~     tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of~     patients most often at the site of the original primary disease. As such there is growing~     interest in further dose escalating to the area of primary disease burden.The aim of this~     work is to look at the feasibility and toxicities of an integrated focal boost to whole~     gland prostate treatment using high dose rate brachytherapy.~   "
33090|NCT02623920|"~     This phase II trial studies how well brentuximab vedotin, bendamustine, and rituximab work~     in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of~     improvement or has not responded to previous treatment. Monoclonal antibody-drug conjugates,~     such as brentuximab vedotin, use antibody to target chemotherapy in cancer cells. Drugs used~     in chemotherapy, such as bendamustine, work in different ways to kill cancer cells.~     Monoclonal antibodies, such as rituximab, kill the cancer cells directly, but also harness~     the immune system to kill the cancer cells. Adding brentuximab to rituximab may improve~     response rates in CD30 positive, CD20 positive Relapsed Refactory NHL.~   "
33091|NCT02623907|"~     With the aging of Chinese population, degenerative valvular disease is becoming more and~     more frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS)~     as an example, the incidence of AS in population over the age of 65 are about 2%, and in~     population above the age of 85 can be amounted to 4-8%, in the Western country. Since the~     invention of transcatheter aortic valve replacement (TAVR),aortic valve disease~     (AVD),including AS and aortic regurgitation (AR), has attracted more and more attention. To~     date, there are few data about the prevalence of AVD in China. The characteristics and~     prognosis of AVD in China are still unknown. Therefore, the investigators design a~     prospective, observational cohort study to investigate characteristics, treatments and~     prognosis of AVD in Chinese elderly population. The results of the study will provide a~     basis for the future national health policy for prevention and treatment of AVD in the~     elderly.~   "
33123|NCT02623491|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     JNJ-55375515 in healthy participants after administration of single and multiple oral doses.~   "
33152|NCT02623114|"~     The purpose of this study was to identify genetic, brain morphologic, and environmental~     biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity~     disorder (ADHD).~   "
46846|NCT02443857|"~     The purpose of this study is to investigate the applicability and feasibility of the newly~     developed robot platform for upper extremity therapy (ChARMin) in children undergoing~     neurorehabilitation.~   "
33092|NCT02623894|"~     Introduction: The process of population aging that is occurring in developed societies~     represents a major challenge for the health system. The aim of this study is to analyze~     factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral~     pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine~     differences by gender in a Spanish population.~      Methods and analysis: An observational, descriptive, cross sectional study.~      Study Population: From the population assigned to the participating Health Care centers, a~     cluster random sampling stratified by age and gender will be performed to obtain 500~     participants aged between 35 and 75. Those who meet the inclusion criteria and give written~     informed consent will be included in the study.~      Measurements: Main dependent variables: cf-PWV determined using Sphigmo Cor System and CAVI~     estimated using VASERA. Secondary dependent variables: telomere length, carotid intima-media~     thickness, central and peripheral augmentation index, ankle-brachial pulse wave velocity,~     ankle-brachial index, retinal arteriovenous index, and renal and cardiac organ damage.~     Independent variables: Lifestyles (physical activity, adherence to mediterranean diet,~     alcohol and tobacco consumption); psychological factors (depression, anxiety, and chronic~     stress); inflammatory factors and oxidative stress.~      Ethics and dissemination: The study has been approved by the clinical research ethics~     committee of the healthcare area of Salamanca. All study participants will sign an informed~     consent to agree to participate in the study in compliance with the Declaration of Helsinki~     and the WHO standards for observational studies. The results of this study will allow the~     understanding of the relationship of the different influencing factors and their relative~     weight in the development of EVA. At least five publications in first-quartile scientific~     journals are planned.~   "
33093|NCT02623881|"~     To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for~     preventing premature birth in twin pregnancies after IVF~   "
33094|NCT02623868|"~     Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability~     to CKD-519 new formulation in healthy male subjects.~   "
33095|NCT02623855|"~     The SHINE study is a randomized controlled study of the effect of a park-based family~     support group on multiple outcomes (including stress and physical activity) in a low income~     population.~   "
33096|NCT02623842|"~     Pilot study, case series conducted in women with a clinical diagnosis of urinary~     incontinence and were treated with radiofrequency technique for capacitive transfer non~     ablative in external urethral meatus. All participants did an hour Pad Test. The~     participants made five sessions of Radio Frequency (RF) with an interval of seven days~     between them. The application of RF was performed by physical therapist trained in the~     technique of radio frequency through the Tonederm® brand device with capacitive transfer~     method using non-ablative handle with electrode in the region of the external urethral~     meatro and coupling electrode placed on the participant's back. For application, the~     participants were in gynecological position. The session had an average duration of 20~     minutes. The temperature was measured by an infrared thermometer when it reached 41graus~     radiofrequency was maintained for 2 minutes.~   "
33097|NCT02623829|"~     Dermatological surgeons wear many hats to care for subjects with skin cancer. While their~     role in cancerous tissue removal results in superior cure rates, there is also a need for~     skilled excisional repair and effective wound healing regimens so the subject can heal with~     the least amount of scarring necessary. As such, numerous techniques have been developed for~     reducing the morbidity associated with excessive scarring. Various flaps and grafts allow~     the surgeon to approximate skin texture, thickness and adnexa with respect to the residual~     surrounding tissue. However, for optimal cosmetic and functional outcome, specific suture~     techniques are often necessary to ensure close wound approximation while simultaneously~     minimizing static tension along the wound edge. In addition, there are post-operative~     techniques for wound care that range from special dressings during the various stages of~     healing to cosmetic procedures for scar modification. Unfortunately, once the operation is~     complete, there is little the surgeon can do to minimize adverse scar formation without~     impairing the healing process. To date, most surgical wounds are allowed to heal at least~     partially before scar revision or modulation is attempted.~      Botulinum toxin presents a unique opportunity for surgeons to affect scar formation~     throughout the duration of the healing process. These effects are likely independent and~     adjunctive to any and all wound care techniques, and are primarily attributed to a reduction~     in dynamic tension on the wound edges. Most importantly, botulinum toxin's one time dosing~     requirements with respect to reduced scar formation precludes the variance inherent to~     standard wound care practices.~      Therefore, it has been proposed that for selected subjects, botulinum toxin may be a safe,~     effective and reliable means for improved post-excisional repair outcomes. Botulinum toxin~     has been investigated as an inhibitor of excessive, post-excisional scar formation in~     plastic surgery and Otorhinolaryngology literature. However, these promising studies have~     yet to combine objective assessment measures of human scar formation in a randomized~     controlled trial. In addition, there are currently no formal studies of botulinum toxin as a~     prophylactic against excess scarring in the dermatological literature. Fortunately,~     Botulinum toxin dosing in the forehead for the purposes of inhibiting excessive scar~     formation is comparable to the amount given for cosmetic purposes, which is commonplace in~     dermatology and well-studied.~   "
33098|NCT02623816|"~     The overall aim of this study is to assess if patients with persistent GERD symptoms~     receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when~     prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking~     omeprazole 30 minutes prior to the first meal of the day.~   "
33099|NCT02623803|"~     The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to~     pancreatectomy patients in regards to analgesia and return of bowel function.~   "
33100|NCT02623790|"~     Dairy products consumption is widely recommended in a healthy diet not only for bone growth~     and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet.~     However, dairy products are a major dietary source of saturated fat that is associated with~     increased risk of coronary heart disease. ln this context, dietary guidelines still advocate~     a restriction in dietary saturated fat for optimal heart health. Nevertheless, the~     association between saturated fat and the risk of heart disease remains highly controversial~     within the scientific community. There is also emerging evidence that the impact of dietary~     saturated fat will be significantly influenced by the food matrix through which it is~     provided. Recent studies indicate that cheese could have a major influence on intestinal fat~     absorption and the magnitude of the after meal release of fat in blood circulation. This is~     of interest because substantial evidence exists indicating that elevated levels of the after~     meal fat levels are associated with increased cardiovascular risk. Therefore, the~     improvement of the after meal fat levels produced by cheese consumption could well be part~     of novel therapeutic approaches contributing to improve cardiovascular risk.~      The general objective of the proposed research is to investigate how cheese consumption~     affects the after meal release of fat in blood circulation in healthy subjects. Our~     hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on~     the after meal fat levels in healthy subjects. Favourable results from the proposed study~     will provide novel and much warranted evidence on the importance of considering changes in~     the after meal fat levels, not only bad cholesterol, as part of the on-going saturated~     fat-heart disease debate and that cheese should indeed be part of a healthy diet.~   "
33101|NCT02623777|"~     During this project the investigators will evaluate whether the effects of arabinoxylan~     oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic~     syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the~     investigators will evaluate whether changes in gut hormone production might explain the~     effect on insulin resistance.~   "
33124|NCT02623478|"~     This study evaluates a new test formulation of a glucose lowering drug, insulin lispro,~     delivered by an insulin pump continuously under the skin. The study will be conducted in~     participants with type 1 diabetes mellitus to investigate how the human body processes the~     new test formulation and its effect on blood sugar levels when it is delivered via an~     insulin pump. Side effects and tolerability will be documented. The study will last about 4~     to 11 weeks, including screening, lead-in and follow up. Screening is required within 28~     days prior to entering the study.~   "
33102|NCT02623764|"~     Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s~     disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has~     been made. Nevertheless, it has been shown in several studies that up to 30% of patients do~     not benefit from treatment. These drugs can have side effects, most frequently from the~     gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most~     frequent signs. It is therefore important to know before the treatment is initiated if the~     patient will likely benefit from the drug or not. It is not possible today with current~     knowledge but this project aims to evaluate a specific index, calculated from an EEG~     registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration~     is done before treatment and the cholinergic index calculated from the EEG registration is~     compared to the clinical outcome. The duration of follow up is 6 months with an extension of~     further 6 months.~   "
33103|NCT02623751|"~     The primary objective of the open-label, dose-escalation study is to investigate the safety~     of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female~     subjects with advanced or recurrent breast cancer. The secondary objective is to investigate~     the pharmacokinetics and efficacy.~   "
33104|NCT02623738|"~     The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic~     solution compared to the placebo ophthalmic solution and to determine if intraocular~     pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is~     non-inferior to latanoprost ophthalmic solution 0.005%.~   "
33105|NCT02623725|"~     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine~     dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.~      Primary Objective~      - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of~     a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects~     from previous CYD dengue vaccine trials.~      Secondary Objectives:~        -  If the primary objective of non-inferiority is achieved: To demonstrate the~          superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third~          CYD dengue vaccine injection in subjects from previous CYD dengue vaccine trials.~        -  To describe the immune responses elicited by a CYD dengue vaccine booster and placebo~          injection in subjects who received 3 doses of the CYD dengue vaccine in previous CYD~          dengue vaccine trials.~        -  To describe the neutralizing Ab levels of each dengue serotype post-dose 3 (previous~          CYD dengue vaccine trials' subjects) and immediately prior to booster or placebo~          injection in all subjects.~        -  To describe the neutralizing Ab persistence 6 months, 1 year, and 2 years post booster~          or placebo injection in all subjects.~        -  To evaluate the safety of booster vaccination with the CYD dengue vaccine in all~          subjects.~   "
33106|NCT02623712|"~     This study will compare two clinically accepted protocols for surveillance imaging in~     individuals who are found to have a small pulmonary nodule on chest computed tomography (CT)~     scans.~   "
33107|NCT02623699|"~     The primary objective of the study is to evaluate the safety, tolerability, and~     pharmacokinetics (PK) of BIIB067 (Isis-SOD1Rx) in adults with ALS. The secondary objective~     is to evaluate the effects of BIIB067 (Isis-SOD1Rx) on levels of superoxide dismutase 1~     (SOD1) protein in the cerebrospinal fluid (CSF).~   "
33108|NCT02623686|"~     It is known from the literature that patients in the Intensive Care Unit do not get enough~     sleep impacting on short and longterm recovery (Tembo & Parker, 2009; Bihari et al, 2012;~     Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with~     essential oils is supported by the literature as being useful in encouraging sleep (Richards~     et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary~     therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating~     whether aromatherapy massage and the use of essential oils in the form of an Inhalation~     Patch (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on~     the critical care unit.~   "
33109|NCT02623673|"~     Retrospective cases series is a non-randomized, open-label, single-center investigation~     (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to~     diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous~     treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone~     0.7mg.~   "
33110|NCT02623660|"~     The purpose of this study is to determine if patients undergoing a total knee arthroplasty~     (TKA) experience a clinically significant reduction in healing time when treated post~     operatively with a specific form of micro and nano-ampere current. The results of this trial~     will provide a basis for generalizing its outcomes to apply to other joint replacements and~     revisions by reducing edema and inflammation and therefore will result in a shorter time to~     heal.~      The study will compare electrically treated and non electrically treated patients by using~     digitally based measurements to determine objective reductions of lower extremity edema~     including intra and inter cellular shifts in fluid distribution, increased range of motion~     (ROM) and muscle strength, and improved functional tests of ambulation.~   "
33111|NCT02623647|"~     The present is a phase I-II study testing the safety and the efficacy of extremely~     hypofractionated radiotherapy for early stage prostate cancer. The study is designed to~     assess GU toxicity while controlling tumor control, in terms of survival free from~     biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable~     intermediate risk prostate tumors.~   "
33112|NCT02623634|"~     the purpose of this study is to analyzes the factors influencing the results of cuff leak~     test, in order to improve the cuff leak test on the accuracy of the prediction on airway~     edema after extubation.~   "
33125|NCT02623465|"~     The study will be conducted in participants with type 2 diabetes on insulin injection~     therapy to investigate how the body processes a test formulation of insulin lispro and the~     effect of the test formulation on blood sugar levels. Side effects and tolerability will be~     documented. The study will be conducted in two parts (Part A and Part B) to achieve its~     objectives. Participants are expected to enroll in both parts.~   "
33126|NCT02623452|"~     The study will be conducted in participants with type1 diabetes on insulin injection therapy~     to investigate how the body processes a test formulation of insulin lispro and the effect of~     the test formulation on blood sugar levels. Side effects and tolerability will be~     documented. The study will be conducted in two parts (Part A and Part B) to achieve its~     objectives. Participants are expected to enroll in both parts.~   "
33113|NCT02623621|"~     A growing amount of reports has consistently evidenced that a sustained inhibition of the~     angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic~     colorectal cancer (mCRC) patients.~      In the last decade different biologic agents targeting angiogenesis have been approved for~     the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently,~     solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even~     beyond the first progression to a bevacizumab-containing regimen. In particular, two phase~     III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line~     switching the chemotherapeutic regimen in patients already treated with bevacizumab in~     first-line. Preliminary experiences evidenced that circulating levels of~     angiogenesis-related markers are significantly modulated during first-line chemotherapy plus~     bevacizumab. In particular, a wide variability of plasma soluble Vascular Endothelial Growth~     Factor Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and~     retrospective data suggest that benefit from the continuation of bevacizumab may be~     restricted to patients with high levels of soluble VEGFR-2 at the first evidence of disease~     progression. This study aims at prospectively validating those retrospective data.~   "
33114|NCT02623608|"~     After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary~     increase, triggering a wave of oxidative stress due to the appearance of excess free~     radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been~     associated with increased risk of cardiovascular disease and type 2 diabetes. Hence,~     postprandial changes in different circulating biomarkers are potential predictors of~     cardiometabolic risk. In addition to the possibility of evaluating acute variations in~     metabolic risk markers in response to different types of fat, the metabolic challenge~     approach may serve as a challenge-meal background in order to reveal possible beneficial~     effects of specific food ingredients. In this study, circulating cardiometabolic~     disease-related biomarkers, including endotoxemia, will be assessed postprandially in search~     for beneficial actions of particular functional food ingredients consumed in combination~     with a high-fat meal.~   "
33115|NCT02623595|"~     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)~     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is~     safe, effective in the treatment of stage IV NSCLC patients who failed in second-line~     chemotherapy.~   "
33116|NCT02623582|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing anti-CD123 chimeric antigen~     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as~     RNA CART123) in Acute Myeloid Leukemia (AML) subjects.~   "
33117|NCT02623569|"~     Arms Assigned Interventions~      Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day~     when positive ETT and HR＞60times/min or negative ETT and HR＞80times/min of subjects.~      Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a~     day when positive ETT and heard rate＞60times/min or negative ETT and HR ＞80times/min of~     subjects.~   "
33118|NCT02623556|"~     720 cases TB (Tuberculosis patients) participants and 360 cases non-TB participants with~     lung disease who all meet the standard are divided into different groups through a~     randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD~     (tuberculin purified protein derivative) in different arms of the same person by blind~     method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure~     the induration and (or) redness of longitudinal diameter size and transverse diameter~     vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we~     observe all kind of adverse events.~   "
33119|NCT02623543|"~     The high prevalence of myopia - especially in Asian countries - is well documented, as are~     the sight-threatening complications of high or degenerative myopia. Retinal detachment,~     glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive~     axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen~     this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at~     night and change the corneal topography to correct low to moderate amounts of myopia. This~     same axial elongation has also been shown to occur in young adults with high near demands,~     however to our knowledge, there are no studies examining the effect of ortho-k lenses in~     this population. Our project seeks to investigate the efficacy of ortho-k in slowing axial~     elongation and myopic progression in subjects between the ages of 21-30. Results will help~     elucidate what role these specialty lenses may have in the management of the myopic patient~     throughout their development, as well as what potential they have in prevention of~     associated degenerative changes.~   "
33120|NCT02623530|"~     Considering the need for an intervention in the context of the Brazilian nursing education,~     in order to develop the skills and dispositions for critical thinking (CT), this study aims~     to fill this gap through a first aid course, comparing a group control and an experimental~     group. In this study will be used two tests, California Critical Thinking Dispositions~     Inventory (CCTID) to review arrangements for the CT, and California Critical Thinking Skills~     Test (CCTST) to evaluate CT skills, both marketed (Facione N, Facione PA, 2009 , 2011).~     Therefore, in order to facilitate the assimilation of PC skills during the course, we~     prepared the model of Active Teaching for Critical Thinking (MEAPC): characterized by a~     teaching method proposed by the author of this work, who understands the educational~     activity active and intentional as mobilizing higher mental processes fundamental to the~     development of the CT.~   "
33121|NCT02623517|"~     Patients with implantable heart devices including pacemakers, defibrillators, and cardiac~     monitors may not seek regular medical care related to their implanted devices. These devices~     are capable of detecting abnormal heart rhythms or other device abnormalities that may~     benefit from clinical action or oversight. A novel healthcare information technology has~     been developed and is being implemented clinically for screening of patients with cardiac~     rhythm devices who seek care in the emergency room setting. This study seeks to examine~     differences in detection of cardiac rhythm disturbances including atrial fibrillation (AF)~     with utilization of this new screening technology, and how often treatment plans change in~     patients who have a heart rhythm abnormality detected.~   "
33127|NCT02623439|"~     The primary objective is to determine overall survival 180 days after transplantation~     involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.~   "
33129|NCT02623413|"~     The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of~     colonization and infection aand hospital-acquired VRE transmissions.~      Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and~     adhering to at least the following standard of care are eligible for study participation:~      Fecal screening for the presence of VRE of all patients within 72 hours of each admission by~     use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72~     hours of discharge Implementation of clinical standards aimed at VRE decolonization is not~     allowed on wards participating in this study, including in the context of clinical studies.~      Sites will be grouped according to their approach regarding contact isolation (see group~     description).~      As a control for external factors a hand hygiene program, including training and adherence~     assessments, will be implemented.~      This observational study prospectively compares wards with different approaches to~     isolation. All screening and isolation measures are already in place on participating wards~     (i.e. constituted a site selection criterion) and are exclusively implemented as part of the~     standard of care. Sites are free to adjust their standard of care as they see fit. No~     intervention will be performed.~   "
33130|NCT02623400|"~     In this project, the investigators will study a cohort of preterm infants, together with~     their parents, during NICU hospitalization and follow their developmental trajectory until~     the age of two.~      An important first scientific goal of the project is to identify objective stress markers~     that can be obtained easily and non-invasively in preterm infants during NICU~     hospitalization. This will include the development of novel techniques to measure stress~     related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for~     preterm infants.~      Secondly, the investigators will study the emotional and bonding processes in parents of~     preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived~     stress and parent-infant bonding will be measured at multiple measuring points. This will~     enable the validation of psychometric instruments in the specific population of parents of~     preterm infants. Also, the investigators can investigate the effect and predictive value of~     the course of parental depression, anxiety and stress scores on child's developmental~     outcome and on parent-infant bonding and attachment.~      Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In~     this study, the investigators will include a cohort of mothers experiencing profound~     prenatal stress due to preterm labor, which will complement the earlier work that has been~     carried out in a low-risk population. The investigators expect more profound changes in~     methylation state of the NR3C1 and other promotor regions in their cohort of mothers exposed~     to important prenatal stress. Secondly, the methylation of oxytocin receptor regions will be~     studied in relation to attachment and bonding.~      An important overall goal of the project is to develop a Perinatal Stress Calculator that~     studies the value of the different neonatal, endocrinological, psychological and~     physiological stress-related parameters to predict differences in psychomotor, cognitive,~     behavioral, and emotional development. This longitudinal study design will enable the~     investigators to use the perinatal stress calculator to study the relation between the~     perinatal stress parameters and later developmental disabilities such as motor impairment,~     cognitive deficits, language delay but also social and behavioral problems such as~     attentional deficits and emotional self-regulation dysfunction.~   "
33131|NCT02623387|"~     The aim of this study is to compare conventional and ultrasound guided paravertebral blocks~     to with respect to efficacy, patient satisfaction and complication rates.~   "
33132|NCT02623374|"~     The study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention~     (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the~     intervention, on the impact of hot flushes experienced by menopausal women in work settings.~     The study involves samples from a minimum of two large employers (who have already expressed~     an interest in taking part) and randomly allocating at least 50 eligible women to the SHCBT~     intervention and another 50 to a NTWC condition (i.e. a minimum of 100 participants in~     total). Both groups will complete baseline questionnaires (A0), and follow up assessments at~     6 weeks (A1) and 20 weeks (A2) post-randomisation. Questionnaires will be completed online~     or paper and pencil, providing data on the outcomes of interest to assess the interventions~     effectiveness and feasibility. Participants of the treatment group will also be invited to~     take part in an evaluation interview at A2. The NTWC will be offered the intervention~     off-trial.~   "
33133|NCT02623361|"~     Patients undergoing arthroscopic hip surgery have been shown to have significant~     post-operative pain that may delay discharge, recovery, and early mobilisation. A~     pre-operative regional anesthesia technique, the fascia iliaca block may be an effective~     method for acute post-operative analgesia.~      This is a prospective, randomized controlled study of the preoperative fascia iliaca block~     for patients undergoing hip arthroscopy.~      The enrolled patients will be randomized to receive either a fascia iliaca block with the~     local anesthetic ropivacaine or to have a sham block. All patients will receive a general~     anesthetic for the hip arthroscopy.~   "
33134|NCT02623348|"~     Randomized controlled trial using pedometers to increase physical activity among patients on~     dialysis.~   "
33135|NCT02623335|"~     The investigators will perform a multi-site cluster randomized trial that uses a~     stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL)~     intervention to usual care for patients considering high-risk vascular (peripheral, cardiac,~     neuro) and oncologic operations. This 24-month study will use a time-dependent cluster~     randomization plan within each of the five study sites: the investigators will randomly~     assign time points for surgeons who perform high risk operations to cross over from usual~     care to QPL intervention. Study staff will audiotape the conversation between the patient~     and surgeon during one preoperative clinic visit; administer surveys to patients and family~     members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions,~     treatments received and associated outcomes. The investigators will use stratified~     purposeful sampling to identify a subset of patients in each study arm who have experienced~     serious complications for qualitative interviews.~   "
33136|NCT02623322|"~     This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in~     otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety,~     efficacy, and pharmacokinetics of MHAA4549A.~   "
33137|NCT02623309|"~     Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative~     procedure for hematological malignancies. It is now well known that this property is related~     to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in~     or generating from the donor graft. For years, however, and despite this unique antitumoral~     activity, Allo-HSCT has been restricted to a limited number of patients due to two major~     limitations: the toxicity of the procedure and the absence of a donor for every single~     patients. More recently the stage has dramatically changed with respect to these two~     restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT~     in older patients but the availability of MRD is even less frequent in elderlies, likely~     related to medical contraindication for graft donation or sibling deaths. UD are routinely~     used but associated with a high incidence of GVHD. As compared to younger populations,~     unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with~     age due to the feared risk of supposed increased lethal infectious complications related to~     the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative~     donors allowing for a safe and efficient transplantation is still unmet. In consequence,~     overall, despite the fact that Allo-HSCT feasibility has been established in the oldest~     patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT~     performed in a population with the higher incidence of hematologic malignancies that usually~     present with the poorest prognosis.~      Thus it is critical developing innovative efficient therapeutic strategies answering this~     unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in~     this aged population. It offers the potential advantage to offer a rapid donor determination~     for virtually every single patient. In addition, our data suggest that in elderlies~     haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor~     effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better~     outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower~     costs (no graft purchase and low post-transplant complications rate) and better QOL likely~     related to low cGVHD-rate. In addition the conduct of such trial at a time when the~     diffusion of the strategy in this population is just starting is really crucial before~     widespread uncontrolled dissemination.~      The investigators propose to address this question by prospectively comparing these 2~     strategies in elderly patients without MRD, in terms of efficacy, safety and including the~     prospective evaluation study of quality-of-life (QOL). They will conduct a national,~     multicenter, open-label, comparative, randomized phase III trial in patients with~     hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has~     not been identified.~      When MRD search is recognized to be a failure, patients will be included in the clinical~     trial after informed consent and randomized in the two strategies based on donor search:~        -  Reference group: Unrelated Donor group~        -  Investigational group: Haplo Donor Group~      Investigators will use a composite end-point embracing the three main causes of failure:~     death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT~     usual objectives as GHVD, NRM, relapse and survival. A specific study of patients' health~     related quality of life will also be conducted using the FACT-BMT questionnaire. In~     addition, the success of the two strategies in term of transplant completion (donor~     determination, transplant realization and time to do so) will be compared.~   "
33138|NCT02623296|"~     This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over,~     drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or~     placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail~     of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450~     substrates will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19~     substrate) and 100 mg caffeine (CYP1A2 substrate).~      Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day~     12 a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450~     substrates will be co-administered either with GLPG1205 or with placebo. The two treatment~     periods will be separated by a wash-out period of at least 28 days.~      Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or~     without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.~   "
33139|NCT02623283|"~     Historically dental health of Scottish children had been poor for many years. Evidence form~     clinical trials of fluoride toothpaste identified a route to improving prevention. Those who~     had poor dental health used fluoride toothpaste infrequently at home. The investigators~     hypothesised that this disadvantage could be overcome by supplying toothpaste to~     disadvantaged families and supervising child toothbrushing at school. In 1997, 534 children~     5.3 years were recruited in 12 primary schools in Tayside; randomly assigned to one of two~     groups - test group followed a home-to-school toothbrushing programme with fluoride~     toothpaste; control group: usual care. Children in test group were provided with~     toothbrushes and toothpaste (1,000ppmF as sodium monofluorophosphate) for home use; also~     brushed their teeth school daily. After 2 years, children participating in the supervised~     brushing programme developed significantly less caries (tooth decay).~      Permission was given for longitudinal follow up of children and dental records. The original~     intervention lasted 30 months and children were re-examined at 36 months after baseline, 48,~     60 and 84 months. At 84 month examination, 77% were available, found prolonged benefits of~     brushing programme. This was 4.5 years after the end of the programme; children were aged~     11.5 years. At age 14 years, 6.5 years after intervention end, 65% of children were~     reexamined; benefit was still evident at 20-26% less caries experience. However, there had~     been greater subject loss and insufficient funds available to undertake a more individual~     followup of participants.~      Since then, records have been followed; up-to-date contact details identified. Using this~     new data, the investigators seek to reconsent the participants, now aged 23 to invite them~     to attend a followup dental examination. This study has the potential to provide unique~     information on longterm costs and benefits of a home-to-school toothbrushing programme.~   "
33140|NCT02623270|"~     The purpose of this study is to determine whether an experienced anesthesia provider can~     adequately and/or easily mask ventilate an anesthetized patient with a commercial~     non-invasive ventilator device.~   "
33141|NCT02623257|"~     The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in~     advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.~   "
33142|NCT02623244|"~     To assess the relationship between ovarian endometrioma and lower urinary tract symptoms,~     sexual function and gastrointestinal symptoms. In addition, the investigators also assess~     the impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual~     function and gastrointestinal symptoms.~   "
33143|NCT02623231|"~     Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients~     with glioblastoma on patient's quality of life including the effect of treatment on mood and~     cognition during treatment.Two subgroups will fill questionnaires :~        -  Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score~          of below 24 indicates a flaw in the level of dementia~        -  Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e~          - 9)~        -  The M. D. Anderson Symptom Inventory (MDASI)~        -  Evaluation of the hospital situation awareness (clinical assessment and questionnaire)~        -  Cognitive assessment which will be carried out by the Department neuropsychological and~          include:~             -  Executive function (Stroop)~             -  Abstract Reasoning (similarities)~             -  -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and~               remembering Literature~             -  Memory function - visual and auditory (ROCF, RAVLT)~             -  Language function: Naming and verbal fluency~             -  Mindstreems Neurotrax~   "
33144|NCT02623218|"~     The purpose of this study is to examine the effects of acupuncture on cerebral blood flow~     (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury,~     to determine if those changes correlate with changes in biomarkers of brain health,~     neuropsychological testing, and symptomatic presentation.~   "
33145|NCT02623205|"~     Despite current medications, morbidity and mortality of Major Depressive Disorder (MDD)~     remain high. According to the World Health Organization, MDD affects 121 million people~     worldwide, and is projected to be the second leading cause of global disability by 2020.~     Monotherapy with SSRIs is the most widely used treatment for MDD. However, on average, SSRIs~     require six weeks for onset of action, and two-thirds of those on SSRIs fail to achieve~     remission.Compounding this problem, patients with residual symptoms are significantly more~     likely to discontinue treatment or relapse, be hospitalized for medical and psychiatric~     conditions, or die of suicide and other causes. Although eliminating ineffective treatment~     trials would significantly reduce patient suffering and healthcare costs,clinicians~     currently do not have the tools to objectively select treatment based on an individual's~     likelihood of remission. Therefore, there is an urgent need to identify markers predictive~     of an individual's SSRI treatment outcome. Developing this personalized treatment requires~     increased understanding of the relationship between pretreatment neurobiology, SSRI-induced~     biological changes, and the corresponding symptom improvements.~   "
33146|NCT02623192|"~     This registry was proposed to investigate the epidemiology of respiratory mechanics in~     patients with ARDS through collecting data from a QI project which was constituted with~     systematic assessments of respiratory mechanics and gas exchange.~   "
33147|NCT02623179|"~     In this protocol, the investigators are examining the use of a novel pathogen testing~     technology and method of identification of antibiotic susceptibility against the~     conventional C & S testing for patients with both complicated and uncomplicated UTIs. The~     investigators will examine the two modes in terms of objective patient related outcomes,~     i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of~     symptoms; 3) quality of life as defined by particularly symptomology and bothersomeness of~     the symptoms; and 4) overall cost.~   "
33148|NCT02623166|"~     The investigators propose to test the feasibility and acceptability of community health~     workers (ASHAs and ANMs) being able to treat sick children in the community. There is a~     national policy for treatment for children aged 2-59 months with illnesses such as~     pneumonia, diarrhea and fever by community health workers (CHWs), this policy has not been~     implemented as yet in Haryana. This research will identify barriers and opportunities for~     use of CHWs as treatment sources.~   "
33149|NCT02623153|"~     The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is~     controversial. The aim of this study was to compare the short- and long-term outcomes of~     XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen~     for locally advanced gastric cancer. The objective of this study is to determine what kind~     of neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and~     improve overall survival in patients with locally advanced gastric cancer.~   "
33150|NCT02623140|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is~     to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent~     with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting,~     using registry detection of clinically driven events~   "
33151|NCT02623127|"~     This study aims to investigate the clinical activity of sunitinib in patients with advanced~     thymic carcinoma who have failed chemotherapy.~   "
33153|NCT02623101|"~     Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising~     number of skin cancer may result in long waiting lists for consultation at departments for~     dermatological care and in increasing health care costs. In case of suspicion on skin cancer~     it is of utmost importance to diagnose and treat in an early phase, preferable in a patient~     friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal~     cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis~     (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated~     incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin~     cancer type. In case of suspicion on BCC, at present, the pathological examination of a~     biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive~     diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the~     diagnosis can be assessed at the first consultation in a non-invasive way and the patient~     can be treated instantly.~      Overall, the aim of this study is to investigate whether reflectance confocal microscopy can~     correctly identify the subtype of basal cell carcinoma.~      Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and~     excision.~   "
33154|NCT02623088|"~     Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a~     independent cardio-vascular risk factor.~      Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study~     measurements of arterial stiffness, and are strong predictors of late cardiovascular events.~      This study will compare long term evolution in arterial stiffness (PWV) and endothelial~     dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.~   "
33155|NCT02623075|"~     Influenza infection in solid organ transplant recipients is associated with increased~     morbidity and mortality compared to non-transplanted controls, due in part to the effects of~     immunosuppression which is necessary to prevent rejection of the transplanted organ.~     However, transplant patients are less likely to produce antibodies when vaccinated and when~     they do, the peak and duration of antibody responses are reduced compared to healthy~     controls. There are considerable differences in the magnitude of these responses, reflecting~     variability in individual responses to the influenza vaccine and to the immunosuppression~     regimen. The investigators hypothesize that chimeric kidney transplant recipients off of~     immunosuppression will have post vaccine immune responses that are comparable to age and~     gender matched healthy controls.~   "
33156|NCT02623062|"~     This study is being conducted in China to provide evidence for inclusion in applications to~     competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective~     in managing the symptoms of heartburn and acid regurgitation in patients with~     gastro-esophageal reflux disease (GERD).~   "
33157|NCT02623049|"~     Background: The incidence of atrial fibrillation(AF) increases substantially with age and it~     is estimated that more than one third of AF patients are octogenarians. Direct oral~     anticoagulants (DOACs) were found favorable compared to warfarin with respect to efficacy~     and safety ( bleeding) across wide range of ages.~      Nevertheless, the rates of bleeding among elderly patients were shown to increase~     substantially with all anticoagulants. Dose-adjustments of DOAC are not universally~     performed among patients older than 80 years old and currently there is paucity of data~     regarding the actual drugs level among these patients. Accordingly, the investigators sought~     to investigate the drug levels of the different DOACs among real world octogenarians who~     receiving guideline-recommended dosage.~      Methods: A cross sectional, prospective study of 120 hospitalized and ambulatory patients~     who are treated with DOACs for AF.~      DOACs blood levels with be compared between octogenarians (n=70) and younger patient group (~     age≤70 year-old; n=50).The cohort will include: 1)Sixty patients on APIXABAN: 40~     octogenarians and 20 younger than 70 years, 2)Forty patients on RIVAROXABAN: 20~     octogenarians and 20 younger than 70 years, and 3) Twenty patients treated with DABIGATRAN:~     10 octogenarians and 10 younger than 70 years.~      DOACs Pharmacodynamic analysis will be performed using commercial kits for diluted thrombin~     time(DTT) and anti-factor Xa activity (AFXa). Drug level will be measured at steady state(~     through levels) and at Tmax after at least 4 days of complete adherence for DOAC~     consumption.~      Study End-Points:The study main objectives are: 1) DOACs levels in octogenarians in~     comparison to patients younger than 70 years and 2)percentage of patients, in each group,~     who have target DTT or AFXa ( predicted) at steady state.~      Potential significance of the study:~      The results of the study may provide new data on DOACs levels in octogenarians and thus~     would either support current recommendations or set the ground for further studies aim to~     optimize DOACs dosage in this vulnerable population.~   "
33158|NCT02623036|"~     The purpose of this study is to use ambulatory blood pressure monitors to investigate~     whether enalapril is superior to lisinopril in managing nocturnal hypertension in patients~     with resistant hypertension currently treated with daytime angiotensin converting enzyme~     inhibitors.~   "
33159|NCT02623023|"~     The purpose of our study is to determine the effect of prophylactic treatment with~     brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL) or placebo therapy~     (Refresh tears®, Allergan; Dublin, IRL) on long-term IOP measurements in patients receiving~     serial intravitreal injection of 0.5 mg ranibizumab (0.05 mL) with six months follow-up.~     Intraocular pressure measurements will be correlated with changes on ancillary testing~     (Humphrey 24-2 visual field testing and optical coherence tomography (OCT) of the optic~     nerve head (ONH). Our study would be the first large, prospective, randomized double-blind~     placebo-controlled trial to examine the relationship between anti-vascular endothelial~     growth factor (VEGF) therapy and sustained ocular hypertension.~   "
33160|NCT02623010|"~     The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction~     treatment will include Rituximab and high dose methotrexate protocol (containing at least~     methotrexate and one more chemotherapy agent).~      Patients with MRI documented response CR or PR will enter the study protocol maintenance~     phase which will include continous treatment with Ibrutinib 560 mg day until relapse or~     disease progression or occurrence of limiting toxicities~   "
33161|NCT02622997|"~     60 women from the Colposcopy Clinic at the Royal London Hospital will be recruited, having~     been referred following an abnormal cervical screening result.~      Aim Human Papillomavirus (HPV) is very common and can cause cervical cancer in some women.~     There is interest in HPV testing in place of the smear test currently used for cervical~     screening. HPV testing has potential for women to take self-samples.~      These self-samples have up to now mostly been placed into liquid to preserve them before~     testing. Using liquid however, makes it more difficult to collect samples at home due to~     spillage and the logistics of posting. Investigators plan to investigate whether dry samples~     are reliable. Investigators would also like to know if samples can still be used if not~     tested immediately, particularly in warm temperatures. This would prove useful in the~     countries that have found it difficult to set up national cervical screening programmes.~      Trial Design Investigators are asking women to take three vaginal self-samples before~     patients' colposcopy examination. The samples will be two swabs and a third using the~     HerSwab device, designed to make taking a sample easier. Investigators will give women~     instruction sheets with illustrations. Samples, taken in a random order so that all samples~     have an equal chance, will be sent to the laboratory for testing but under different~     conditions. Samples will be either frozen immediately, stored at 25ºC for one week or two~     weeks and then frozen. All samples will then undergo HPV testing. Investigators wish to see~     if all conditions and swabs provide similar amounts of HPV.~      Enrolment is planned to start in May 2015. Sample processing and testing will continue until~     enrolment is complete and for a further month. Smear and biopsy results will be collected~     for up to 6 months to see if they affect quantities of HPV.~   "
33162|NCT02622984|"~     The traditional paradigm that relies upon training physicians and nurses or uses on-site~     interventionists to perform screening, brief intervention, and referral to treatment (SBIRT)~     for alcohol has proven unsustainable in most clinical settings. The Remote Brief~     Intervention and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth~     service model with potential to improve public health through evidence based counseling for~     patients who exceed the NIAAA low risk drinking limits or have evidence of an Alcohol Use~     Disorder with professional and self-help treatment. For those that are appropriate, the~     R-BIRT service will provide facilitated referrals to specialized alcohol abuse treatment.~     The service model is being studied in the emergency department (ED) setting to demonstrate~     its utility in a medical setting with a very high prevalence of risky alcohol use and~     Alcohol Use Disorders; however, the model is relevant and will be accessible to a broad~     array of healthcare settings, including primary care practices. Our new model, the R-BIRT,~     challenges the prevailing paradigm and offers the promise of not only clinical efficacy but~     increased cost effectiveness as well.~   "
33163|NCT02622971|"~     Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to~     measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any~     procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric~     test in isokinetic dynamometer to measure muscle function). After, volunteers performed the~     exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after~     exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS~     measure and MVC test were repeated. The treatments according to randomisation were performed~     three minutes after exercise protocol and it were performed again in 24, 48, 72h after~     eccentric exercise.~      The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle~     damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute,~     1 hour, 24, 48, 72 and 96 hours after exercise protocol).~   "
33164|NCT02622958|"~     The purpose of the study is to determine whether the PH94B nasal spray is effective for~     Acute Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The~     hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to~     improve performance and interaction anxiety in patients with diagnosed Social Anxiety~     Disorder (SAD).~   "
33165|NCT02622945|"~     This study aims to determine whether transcranial direct current stimulation (tDCS) paired~     with speech-language therapy is more beneficial than speech-language therapy alone in acute~     and chronic post-stroke aphasia.~   "
33166|NCT02622932|"~     The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of~     [14C] Anlotinib in Patients With Advanced Cancer patients.~   "
33167|NCT02621879|"~     Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in~     Treatment of Recurrent Sacrococcygeal Pilonidal sinus~   "
33168|NCT02621866|"~     The investigators have shown that a single dose of ultraviolet irradiation (as found in~     sunlight) will lower blood pressure for around one hour. They are now testing whether daily~     UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.~      They will also measure the effect of daily UVA on other cardiovascular risk factors.~   "
33169|NCT02621853|"~     Fatty liver disease including liver steatosis (fat deposition) is a major health problem~     worldwide. It is considered pathological when fat accumulation exceeds 5% of the liver~     weight. Transplantation represents the ultimate treatment for end stage liver disease.~     However, the discrepancy between the demand for donor organs and their availability presents~     one of the greatest hurdles of liver transplantation. Therefore, extended criteria organs~     have to be considered to overcome this shortcoming. Hepatic steatosis is one of the most~     important criteria defining extended-criteria donor liver. In liver transplantation,~     'severe' fat deposition in donor liver is a major cause of graft failure while 'mild'~     deposition is considered transplantable and 'moderate' deposition represents the gray zone~     and remains difficult to assess. Surgeons usually perform a hepatic steatosis assessment~     during liver donor surgery. However, this method is very subjective and difficult especially~     when inexperienced surgeons or trainees are concerned. Furthermore, it has recently been~     documented that the assessment of steatosis is challenging even in the hands of experienced~     surgeons. Theoretically, a better way to assess steatosis before organ procurement would be~     a non-invasive imaging technique. However, some of these techniques appear to lack the~     sensitivity to accurately quantify hepatic fat content while others are complex, expensive~     and inconvenient to use in the setting of organ procurement. Therefore, liver biopsy remains~     the reference for grading hepatic steatosis. In daily practice the assessment and~     quantification of steatosis by a pathologist during organ procurement is more complex~     related to the lack of availability of dedicated hepatopathologists outside of office hours~     and in smaller community hospitals. A simple and short technique is therefore required to~     assess liver steatosis before retrieval. We have recently demonstrated that Raman~     spectroscopy could provide an accurate, rapid and real-time assessment of hepatic fat~     content and correlated highly with the gold standard (i.e. histopathological assessment of~     liver sections) in an animal model of liver steatosis. The purpose of this study is to~     validate the use of Raman spectroscopy for quantitative assessment of hepatic steatosis. In~     the hands of the surgeons this device can provide an immediate, robust tool to assess the~     suitability of donor livers at the site of retrieval prior to liver transplantation.~   "
33170|NCT02621840|"~     The investigators aim to investigate the impact of mandating on-site pre-admission testing~     on cataract cancellation rates in a randomized, prospective, intervention study. Cataract~     extraction is the most commonly performed ocular surgery making surgical training an~     integral component of ophthalmology residency. Patient cancellation of surgery results in a~     financial burden to the institution and a loss of essential educational experiences for the~     residents. An earlier study explored variables impacting cancellation rates and identified~     incomplete pre-admission testing as a major contributing factor to surgery cancellation.~      Patients will be randomized to either 1) the intervention group where on-site pre-admission~     testing will be mandated or 2) the control group, where on-site pre-admission testing will~     be offered but not mandated. Cancellation rates will be collected prospectively and~     statistical analysis utilized to evaluate the significance of intervention.~   "
33171|NCT02621827|"~     This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in~     non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months~     post-partum in women who are exclusively breast-feeding.~   "
33172|NCT02621814|"~     The purpose of this study is to assess the infants' growth rate and incidence of feeding~     intolerance fed by Friso formula compared with Wyeth S26 formula.~   "
33173|NCT02621801|"~     This prospective, waitlist-control study is evaluating the benefits of a stress management~     and resiliency training program for residents (SMART-R).~      The primary aim of this study is to determine whether the SMART-R is effective at increasing~     coping skills and reducing stress among residents, reflected by changes in constructs such~     as emotional growth, perceived stress, optimism, and coping styles. Objective parameters~     (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)~     measured with the Basis health tracking device will help correlate objective signs to~     subjective report of stress.~   "
33174|NCT02621788|"~     This prospective pilot study evaluated the benefits of a stress management and resiliency~     training program for residents (SMART-R).~      The primary objective of this study is to determine whether the SMART-R effectively reduces~     burnout and stress and enhances coping skills in first year residents. Objective parameters~     (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)~     measured with the Basis health tracking device will help correlate objective signs to~     subjective report of stress.~      The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year~     residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance~     residents' emotional and physical well being, reduce reports of stress, anxiety, depression,~     and physical complaints, as well as increase overall resiliency.~   "
33175|NCT02621775|"~     The aim of this study was to assess the effects of a 5-week standardized cognitive~     behavioral treatment of stress management conducted via e-learning or face-to-face on~     patients responding to the diagnosis of adjustment disorder with anxiety (ADA) according to~     the DSM- 5 (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .~   "
33176|NCT02621762|"~     The study aims to determine the effect size of magnesium and bicarbonate supplementation as~     a basis for future randomized controlled trials aiming at the T50-guided improvement of hard~     clinical endpoints in dialysis patients.~   "
33177|NCT02621749|"~     The primary objective of this study is to investigate the impact of continuous renal~     replacement therapy and intermittent renal replacement therapy on microbubble / cerebral~     microemboli generation in a cohort of critically ill patients with dialysis-dependent acute~     kidney injury.~   "
33178|NCT02621736|"~     Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of~     all 7 year olds. MEN is often leading to psychosocial problems because of its burden and~     stigmatism.~      The only available medical treatment option is the vasopressin analogum Desmopressin®.~     However, according to the literature, only one third of patients shows a good treatment~     response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with~     Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side~     effects like water intoxication and hypertension.~      Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in~     patients with MEN compared to controls and lower in patients with severe bed wetting~     compared to patients with only slight bed wetting.~   "
33179|NCT02622906|"~     The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some~     cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies~     suggest that treatment with somatostatin analogue would reduce transfusion requirements in~     patients with recurrent bleeding due to angiodysplasia.~      No randomized studies are available. The main objective of this study multicenter,~     prospective, randomized, was to assess the transfusion requirements in patients with~     recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin,~     Pasireotide, versus placebo.~      Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic~     treatment failure, with a need transfusion at least 6 red blood cells during the 6 months~     prior to inclusion could be randomized to receive monthly intramuscular injection of~     Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an~     additional 6 months after stopping treatment. A test monthly clinical and laboratory was~     performed during the six months of treatment then quarterly during the six months of~     surveillance.~   "
33180|NCT02622893|"~     Background: We performed this prospective clinical study to compare the post-operative~     recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic~     nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic~     consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic~     nephrectomy patients within the first 24 hours.~      Methods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal~     laparoscopic nephrectomies were enrolled. All patients in both groups received epidural~     catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of~     the surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through~     epidural catheters and extubated. In the post-operative care unit, patients started to~     receive a continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with~     patient-controlled boluses of an additional 4ml by a patient controlled epidural analgesia~     (PCEA) device. They were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog~     scale (VAS)≥4). Total analgesic consumptions from PCEA devices, VAS scores at rest and~     during mobilization, heart rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at~     extubation (0th min-basal) and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th~     hours as well as number of patients who require rescue analgesic were recorded. Nausea,~     vomiting, time to first mobilization, return of bowel sounds and hospital stay were also~     documented.~   "
33181|NCT02622880|"~     The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days~     before surgery , on the number and characteristics of postoperative infections for a period~     of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell~     cancer patients, candidates for surgery.~   "
33182|NCT02622867|"~     The purpose of this study is to evaluate the effects of the probiotic Lactobacillus~     plantarum 3547 over different inflammation and immune system markers on a healthy~     middle-aged group.~   "
33183|NCT02622854|"~     To compare effectiveness in reducing triglycerides between daily plasma exchange and~     glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis~     with mildly elevated triglycerides~   "
33184|NCT02622841|"~     The aim of this study is to assess the feasibility and safety of combining stereotactic body~     radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of~     painful unstable metastases of the thoracic and/or lumbar spine.~   "
33185|NCT02622828|"~     The purpose of this study is to examine whether intervention strategies targeted at the~     level of the environment (e.g. improving access to community based leisure groups,~     transportation) can successfully promote the community participation experiences of~     community-dwelling older adult Manitobans who use wheelchairs in the winter.~   "
33198|NCT02622659|"~     Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre~     clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with~     influenza (acute upper respiratory infection).~   "
33186|NCT02622815|"~     There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has~     the capacity to activate the hemostatic system and this leads to an increased thrombotic~     risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are~     commonly characterized by hemostatic abnormalities, recognized only by laboratory testing,~     which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly~     reported to be associated with tumor progression and poor prognosis in various carcinomas.~     On the other hand, thrombotic event can represent the first signal of the presence of an~     occult tumor. These findings suggest that the coagulant pathway might play a role in the~     preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical~     activation of the hemostatic system in an otherwise healthy subject, may predispose not only~     to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer~     prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an~     ongoing prospective Italian multicenter study organized around two tightly-interconnected~     research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer~     risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood~     donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise~     region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt~     thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease~     outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease~     free survival in limited disease) in cancer patients with different types of solid tumors~     (i.e. breast, lung and gastrointestinal cancers).~      Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful~     for anticipation of cancer diagnosis. In addition, the results of this study might help to~     evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of~     the disease extension.~   "
33187|NCT02622802|"~     The most important guideline for drug prescription concerning pregnant women is 'drugs~     should be given only if the maternal benefits outweigh the potential risk to the fetus'.~     However, poor data is available on maternal drug disposition and transfer through the~     placenta, so the evidence available for decision making in clinical practice is weak.~      An ex-vivo placenta perfusion model will be used to explore the mechanisms governing~     differences between fetal and maternal drug exposure. The expression of placental~     transporters and cytochrome P450 (CYP) enzymes will be investigated in primary placenta cell~     culture and placental biopsies from different gestational stages to learn how the placental~     drug transfer and disposition is regulated.~      The investigators choose to examine the transfer of paracetamol, erythromycin and~     azithromycin because these drugs are commonly used in human pregnancies and have different~     metabolic pathways.~   "
33188|NCT02622789|"~     An assessment of the effectiveness of Pilates based physical therapy exercises for patients~     with low back pain (LBP) and its influence on spinal movement and patient reported~     functional disability.~   "
33189|NCT02622776|"~     This pilot study is the first step in the development of an new assay that may be further~     tested as a screening method for ovarian and endometrial cancers.~   "
33190|NCT02622763|"~     Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.~   "
33191|NCT02622750|"~     The purpose of this study is to compare triple-branched stent placement with total-arch~     replacement in the treatment of acute DeBakey I aortic dissection . The investigators design~     optimal effect compera prospective, multi-center, randomized, open-label, parallel-group,~     non-inferiority clinical trial.~   "
33192|NCT02622737|"~     Introduction: Population aging is associated with increased prevalence of chronic diseases.~     Parkinson's disease (PD) is the second most common neurodegenerative disease in the world~     population, affecting motor function and functional independence progressively. The~     physiological aging promotes the gradual reduction of body weight, lung function, peripheral~     muscle strength, cardiopulmonary endurance and physical capacity, which increase the~     debilitating effects. Aging, when associated with PD, can induce loss of functionality,~     postural changes, further affecting the nutritional status, worsening the quality of life~     and functional independence of the individual. Although physical therapy is commonly applied~     with a variety of methodologies to PD patients, evidence for the effectiveness of these~     interventions is lacking.~      Objective: The primary objective of the study is to compare the effects of Functional~     Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly~     participants with PD. In addition, the secondary objectives are to compare the effects on~     cardiopulmonary endurance, posture, postural control, executive function, quality of life~     and functionality of individuals with PD.~      Methodology: This is an interventional, randomized, blinded, longitudinal and prospective~     study. This research will be conducted in the State Reference Center for Health Care of the~     Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The~     Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with~     undergo training with Stationary Bike and the Experimental Group 3 will be submitted to~     exergame training using Xbox360 with KinectTM sensor. All the interventions will be~     performed three times per week, with 50 minutes per session, during 8 weeks.~   "
33193|NCT02622724|"~     In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human~     interferon beta-1a) is compared to placebo. Investigation is conducted with patients who~     have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time~     which a patient need to be on the ventilator and improve patient's chances of survival.~     Currently there are no approved drugs for treating moderate or severe ARDS patients.~   "
33194|NCT02622711|"~     The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused~     on weight loss in a group of overweight or obese women previously treated for early breast~     cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase~     physical activity and decrease sedentary time, taking advantage of a pedometer-like device.~   "
33195|NCT02622698|"~     Investigators performed a randomized controlled trial of 62 patients undergoing elective~     abdominal operations. The treatment group was provided a liquid protein supplement and~     instructed to take a dose three times daily for the first 20 postoperative days.~     Investigators followed patients for six months and compared wound healing and changes in~     weight and laboratory values.~   "
33196|NCT02622685|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.~   "
33197|NCT02622672|"~     Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10~     (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of~     coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the~     water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble.~     The purpose of this study was to investigate the effects of a water-soluble ubiquinol~     supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.~   "
33199|NCT02622646|"~     Haemophilia A is an inherited bleeding disorder caused by a deficiency of factor VIII~     (FVIII). Patients with severe hemophilia A have a FVIII plasma concentration less than1~     IU/dL and experience spontaneous and trauma-induced bleeds. Joint bleeds lead to hemophilic~     arthropathy resulting in progressive disability. Patients with moderate hemophilia (FVIII~     level between 1-5 IU/dL) are characterized by fewer hemarthroses, usually trauma-induced,~     and a decreased likelihood of developing arthropathy. This clinical observation led to the~     use of prophylactic FVIII infusions to convert patient´s bleeding phenotype from severe to~     moderate with the result of decreasing or preventing arthropathy.~      Prophylactic regimens may be effective when based on standard fixed-dose protocols (that~     assumes one approach fits all patients) or phenotypic dosing determined by bleeding~     patterns, but do not protect all patients with severe haemophilia from joint damage caused~     by spontaneous or activity-triggered bleeding.~      Individualized treatment in haemophilia A takes into consideration all available information~     about the patient, not only his phenotypic bleeding pattern. Some of the factors that~     contribute to the observed interpatient variability include baseline or residual FVIII~     activity, the pharmacokinetic (PK) profile of the replacement factor, the individual's level~     of physical activity and perceived risk of traumatic bleeding, the presence or absence of~     joint disease, presence of comorbidities and adherence to the dosing regimen.~      Objectives:~      Identify and analyze cause(s) of poor bleeding control in patients on prophylaxis treatment~     and study the clinical impact of a personalized pilot program with a 1 year follow up to~     act on the specific causes.~        1. Describe PK parameters in patients on prophylaxis treatment with Advate®.~        2. Analyze differences in PK parameters in non-controlled vs well controlled patients.~        3. Identify causes of poor clinical outcome in non-controlled patients. Patients'~          individual variables that influence bleeding risk will be studied (individual PK,~          bleeding pattern, joint status, physical activity, life style and patient's adherence).~        4. Study the improvement in clinical outcomes (ABR and Joint status) of a 1 year~          Personalized Prophylaxis Program that acts specifically on the previously identified~          causes of bleeding in non-controlled patients (named: short half-life, high bleeding~          pattern, joint damage, high risk physical activity, active life style and poor~          patient's adherence).~   "
33200|NCT02622633|"~     This study aims to analyze the effectiveness and feasibility of using an implantable system~     that provides epidural electrical stimulation directly to the left prefrontal dorsolateral~     cortex (Brodmann area 9/46) in patients with chronic and refractory Depressive Disorder~     Major.~   "
33201|NCT02622620|"~     Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading~     and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very~     limited.In this study, the investigators will use multi-b-value diffusion-weighted~     imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced~     MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.~   "
33202|NCT02622607|"~     Bone metastases are common in patients with advanced non-small-cell lung cancer (NSCLC) and~     can have devastating consequences. Preventing or delaying bone metastases may improve~     outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current~     indications for bisphosphonates include the treatment of metabolic disorders of bone~     metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of~     malignancy (HCM), and the prevention of skeletal-related events(SREs）from malignant bone~     disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid（ZOL) in~     particular, can prevent bone loss from cancer treatment.There is also emerging evidence that~     the benefits of bisphosphonate therapy in the oncology setting are more extensive. This~     study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in~     patients with stage IIIB/IV NSCLC could reduce the rate of bone metastases ,improve~     progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases~     .~   "
33203|NCT02622594|"~     This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral~     (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.~      Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment~     2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA~     application to their right face and ALA application only to the left face 60 minutes prior~     to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include~     microneedling performed prior to ALA application to their left face and ALA application only~     to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds~     (16 minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA~     application to their right face and ALA application only to the left side of their face 30~     minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4~     will include microneedling performed prior to ALA application to their left face and ALA~     application only to the right side of their face 30 minutes prior to BLUE light treatment~     for 1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin~     encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal~     dorsum, the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline,~     the nose and the chin), the upper lip (not including the vermilion border) and the chin~     (bounded by the lower edge of the vermilion border, the cheek junction and the jawline). The~     treatment areas will be not be occluded. A line will be drawn with a marker that intersects~     the nose, forehead, upper lip and chin in the midline. The left face is defined as the face~     to the left of this line and the right face is defined as the face to the right of this~     line. Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment~     and at 1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded~     with respect to the randomization will conduct grading of the subject's actinic keratoses~     and photodamage. Tolerability of treatment will be assessed by evaluations of the local skin~     response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.~      Safety will be evaluated by adverse events and local skin responses reported during the~     study~   "
33204|NCT02622581|"~     Open, non-interventional, prospective, multi-center clinical research platform with the main~     objective to assess molecular biomarker testing, treatment and outcome of patients with~     advanced or metastatic NSCLC in Germany~   "
33205|NCT02622568|"~     The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as~     a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment~     and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the~     pediatric population. The investigators will compare the single and combination treatment~     modalities over identical time points in patients with non-facial verruca vulgaris. One of~     the current options for care for non-facial verruca includes cryotherapy, which is a painful~     and destructive method performed in the pediatric dermatology clinic. This study aims to~     establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment~     as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators~     hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial~     verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy~     treatment followed by topical application of Veregen ™ ointment. This novel treatment~     modality will be useful in the pediatric dermatology community offering a less invasive,~     painless option for treatment of non-facial verruca vulgaris.~   "
33206|NCT02622555|"~     Overactive bladder syndrome complicates life for many women. 60-70% of women report~     improvement with treatment but the antikolinergic treatment is often limited by the adverse~     events, for example dry mouth, obstipation and urinary retention. Mirabegron is a~     b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies has~     demonstrated similar efficacy comparing Mirabegron with antimuscarinics but a significant~     reduction of adverse events. The aim of the present study is to survey cardiovascular~     adverse events with Mirabegron treatment in a general population suffering from overactive~     bladder syndrome.~   "
33207|NCT02622542|"~     The purpose of the study is to conduct a randomized controlled trial comparing best medical~     therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for~     uncomplicated acute type B aortic dissection.~   "
33445|NCT02619292|"~     The purpose of this study is to determine if participating in a Mindful Movement Program~     (MMP) (learning how to be mindful in one's movement), positively affects the body's immune~     functions improves mindfulness and reduces worries about cancer returning. All participants~     will be in this study about three months.~   "
33208|NCT02622529|"~     This study aims to investigate patients' experience of awake surgery of the brain. Patients~     therefore must suffer a disease that makes the technique of awake craniotomy necessary.~      In more detail, the investigators are performing this study in order to investigate the~     influence of fear on pain perception during surgery for patients undergoing awake surgery~     for lesions within the brain. In the event of finding a correlation between fear of the~     surgery and intraoperative pain perception, the investigators aim to reduce possible fear~     beforehand.~      An additional goal of the investigators is to identify psychological consequences of awake~     craniotomy timely and admit patients to an adequate therapy if necessary.~      There will be no changes regarding the actual treatment of the disease. In case of a~     consent, the patient will receive questionnaires at three timepoints: 1. day before surgery.~     2. third day after surgery. 3. at 3-6 months postoperatively at the outpatient clinics.~      The benefit of participating in this study is the possibility of detecting psychological~     consequences of awake craniotomy at an early stage. If required, patients will then receive~     treatment timely.~      There are no additional risks. Theoretically there is only a data risk after analysis.~      Patients are free to decide if they want to participate within this study. There are no~     changes in the actual treatment if patients deny participation. In case of participation,~     patients have the right to quit at any time with no reasoning at all.~      During the study investigators are collecting health-related data. If patients quit before~     the study end, data will still be used in pseudonymized form. After 10 years, data will be~     destroyed.~      In case of participation the only duty for the patient is to fill out the questionnaires at~     the above mentioned three time points.~      The investigators conduct this study based on all rules of law regarding data protection.~     Investigators only use the collected data in relation to this study. All investigators are~     under obligation to secrecy.~   "
33209|NCT02622516|"~     Vertigo, dizziness and imbalance are the main symptoms of vestibular dysfunction. They can~     lead to physical consequences, such as the reduction of postural control and falls,~     psychological and / or psychiatric consequences such as anxiety and depression, panic and~     cognitive changes, especially in the elderly. It is known that individuals affected by these~     disorders may improve with the completion of vestibular rehabilitation protocol.Treatment~     protocols can introduce variability of exercises to control the signs and symptoms related~     to vestibular diseases, in order to customize the treatment to affected individuals .~   "
33210|NCT02622503|"~     The purpose of the study is to obtain an overall picture of rituximab treatments and~     treatment responses in RA patients.~   "
33211|NCT02622490|"~     Thirty participants without serious concomitant diseases consume either a high- or a low~     carb. meal either as one single meal or as 5 small portions in the morning and are tested~     for effects on major cardiovascular risk markers and on metabolic rate for three hours on~     each occasion.~   "
33212|NCT02622477|"~     The purpose of the study was to assess the clinical outcome of patients with a mild to~     moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).~   "
33213|NCT02622464|"~     Post-operative scarring on vocal cords is responsible for disorders of the vibration of the~     lining to the original dysphonia can be troublesome for the patient both in his private and~     professional life. There is no currently codified treatment for this type of situation and~     no therapeutic antifibrotic has been effective. Cell therapy is a promising new~     approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining~     cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a~     heterogeneous cell population including multipotent stem cells similar to mesenchymal stem~     cells present in bone marrow. The investigators hypothesis is that the trophic and~     antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible~     for dysphonia.~   "
33214|NCT02622451|"~     This pilot study conducts feasibility and exploratory intervention outcome research that~     will lead to the development of a personalized intervention framework that seeks to preempt~     the progression from early drug use to more chronic abuse and dependency. The study will~     explore moderators representing two frameworks, risk severity and differential sensitivity.~     Moderators will be explored in their ability to influence the differential efficacy of two~     adolescent drug abuse interventions.~   "
33215|NCT02622438|"~     On the basis of published data and our results indicating that oxidative stress may~     contribute to the peripheral skeletal muscle dysfunction in patients with FSHD,~     investigators conducted a pilot randomized double-blind placebo controlled trial to test~     whether oral administration of vitamins and mineral could improve the physical performance~     of patients with FSHD.The result of this clinical trial showed that antioxidants~     supplementation may improve skeletal muscle function of patients with FSHD and suggest that~     an antioxidant strategy adapted may be a relevant therapeutic approach for these patients.~     Since then, patients with FSHD who attend consultation at Montpellier hospital are~     systematically supplemented with antioxidants according their own blood tests.~   "
33216|NCT02622425|"~     This randomized, placebo-controlled trial aims to determine the effects of daily~     administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on~     cardiovascular health biomarkers, microbiota composition and functioning and intestinal~     barrier function in overweight subjects.~   "
33217|NCT02622412|"~     Breathlessness is a common and distressing symptom in patients with advanced diseases like~     cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung~     fibrosis, which broadly impacts on patients' quality of life and may result in high burden~     for carers.~      This single-blinded randomized controlled fast track trial evaluates the effectiveness of a~     multi-professional breathlessness service in patients with advanced and chronic diseases.~     The intervention group will get immediate access to the breathlessness service whereas the~     control group will receive standard care and get access to the service after a waiting time~     of eight weeks. Primary endpoints are mastery of breathlessness and quality of life,~     measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of~     symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of~     the breathlessness service from the perspective of the German health system is a further~     study aim.~   "
33243|NCT02622074|"~     The purpose of this study is to evaluate the safety, tolerability and clinical activity of~     pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant~     treatment for participants with triple negative breast cancer (TNBC).~      The primary objectives of this study are: 1) to determine the safety and tolerability and 2)~     to establish a recommended Phase 2 dose for the six combination regimens as a neoadjuvant~     treatments for participants with TNBC.~   "
33291|NCT02621294|"~     Our objective is to determine the dietary requirement of protein for strength and endurance~     exercise trained (more than 4 months training experience) individuals between 18 - 30 years~     of age using the indicator amino acid oxidation (IAO) method. This study will be the first~     to determine the required quantity of protein need per day in strength- and endurance~     trained young adults using the IAO method.~   "
33446|NCT02619279|"~     The objective of the study is to determine whether a livelihood intervention can improve~     health and schooling outcomes of the children of woman participating in a livelihood~     intervention in rural Uganda.~   "
33218|NCT02622399|"~     Caregiver social isolation adversely impacts child health and developmental outcomes; it~     also contributes to suboptimal engagement in health care services and enrichment resources,~     which also elevate risk for poor outcomes in childhood. The proposed pilot intervention aims~     to reduce social isolation and promote engagement in health promoting enrichment and~     activities, by embedding a community health worker assisted forum in a community-driven~     mobile communications (using a platform supported by the company txtwire).~      The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5~     years old who reside in the Roxbury, Dorchester, and Mattapan neighborhoods of Boston.~     Participants will be recruited from Boston Medical Center and community sites in Roxbury,~     Dorchester, and Mattapan. The investigators will use quality improvement methods to improve~     the utilization of the mobile communications shared through txtwire to build collective~     efficacy for children and social support and engagement that will optimize family resiliency~     and thereby promote child well-being, as well as, assess the acceptability of the~     intervention, and logistics of the field implementation to ultimately inform an~     appropriately powered RCT. Participants will receive compensation for participation at~     baseline and follow-up interviews.~      The intent of this study is to support developement of mobile social communications to~     reduce social isolation.~   "
33219|NCT02622386|"~     The purpose of this study is to determine the anti-inflammatory effect of high-dose~     riboflavin supplementation on chronic plaque psoriasis. Psoriasis is a common chronic skin~     disorder that affects over 4 million people. There is no cure for psoriasis and treatment is~     directed at controlling patients' symptoms. Amongst patients with skin disease, there is~     significant interest in using complementary alternative medicine and vitamins to treat their~     disease. Previous human case reports suggest that riboflavin, commonly known as Vitamin B2,~     is clinically effective for the treatment of psoriasis; however, they were not conclusive.~     More recent human trials have shown that 400 mg of daily oral riboflavin is a safe and~     well-tolerated medication to administer to humans. For the purpose of this study, the~     riboflavin is used as an investigational drug.~   "
33220|NCT02622373|"~     The purpose of this study is to gain information that may be useful in helping to figure out~     better or newer ways to provide nutrition to babies born premature.~   "
33221|NCT02622360|"~     Developmental dyslexia is a highly heritable disorder in which reading skills are~     compromised despite normal intelligence and appropriate reading instruction. Reading~     problems in dyslexia are thought to primarily originate from weak speech sound~     representations or poor phonological skills. Dyslexia has also been associated with~     short-term or working memory dysfunctions. The current study will address the presence of~     these problems in dyslexic adults by the means of recording auditory and audio-visual~     mismatch negativity (MMN) and its magnetic counterpart (MMNm) to determine neural speech~     sound discrimination, representations and integration of seen and heard language. In~     addition to analyzing neural processing of syllables or (pseudo-)words, a new approach to~     MEG acquisition and analysis to characterize the neural responses during comprehension of~     complex real-life speech will be used. Furthermore, reading, phonological and cognitive~     skills of these participants will be determined with a neuropsychological test battery. The~     associations between the neural, neuropsychological and genetic measures will be studied.~     This project will illuminate the nature of neurocognitive dysfunctions in dyslexia and their~     relationship with genes.~   "
33222|NCT02622347|"~     The purpose of this study is to test the validity of our in-house chemiluminescence assay~     for measurement of folliclestimulating hormone (FSH) serum levels before and during~     exogenous recombinant FSH (rFSH) administration.~   "
33223|NCT02622334|"~     The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151~     following 7 days of topical ocular treatment in patients with primary open angle glaucoma or~     ocular hypertension.~   "
33224|NCT02622321|"~     This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics~     of prophylactic emicizumab treatment in patients previously treated with episodic or~     prophylactic bypassing agents. Episodic bypassing agent patients will be randomized in a 2:1~     fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be~     stratified across Arms A and B according to the number of bleeds they experienced over the~     last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>=] 9~     bleeds); Arm B patients will have the opportunity to switch to emicizumab prophylaxis after~     24 weeks on-study. Prophylactic bypassing agent patients will switch to emicizumab~     prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks~     after the last patient has enrolled in Arms A or B or until approximately 50 patients have~     enrolled in Arm C, whichever occurs first. Episodic bypassing agent patients who previously~     participated in a Non-Interventional Study BH29768 but were unable to enroll in Arms A or B~     prior to their closure will have the opportunity to enroll in Arm D until 24 weeks after the~     last patient has enrolled in Arms A or B or until approximately 35 patients have enrolled in~     Arm D, whichever occurs first. Like patients in Arms A and C, Arm D patients will receive~     emicizumab prophylaxis from the start of the trial. All patients will continue to receive~     standard of care/background treatment with their usual episodic bypassing agent therapy to~     treat breakthrough bleeds, as needed.~   "
33225|NCT02622308|"~     This experimental study will look at the effects of INP therapy for two patient groups: 1)~     patients with reduced peripheral circulation and chronic wounds in patients with renal~     disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project~     is designed as a non-randomized clinical trial with single-subject multiple baseline design.~     Also the intervention will be subjected on the same leg for each individual throughout the~     study period. The other leg will act as a control. A baseline measure with patient history~     collection will be performed before a four-week intervention period. These measures include:~     Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler~     sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health~     survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the~     same tests will be repeated. A final follow-up test will be two weeks after cessation of the~     intermittent negative pressure intervention. The study will look at the effect of INP on~     renal failure patients who are given dialysis at a dialysis center located at Oslo~     University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the~     necessary training to perform this project. Outcome variables assessed before, during and~     after the 10-week study period will be: wound healing, quality of life, skin perfusion~     pressure and segmental pulse-volume recording. The aim of this project is to prospectively~     examine and elucidate the effect of intermittent negative pressure therapy on clinically~     relevant measures related to the reduction of peripheral macro- and microcirculation in~     patients with renal failure undergoing dialysis treatment.~      The hypothesis of the study is:~        -  Application of INP in patients with renal failure, by the use of the FlowOx™ device,~          will improve wound healing and peripheral circulation in the foot compared to before~          treatment (baseline) in patients undergoing dialysis treatment.~        -  Application of INP in patients with renal failure, by the use of the FlowOx™ device,~          will improve macro- and microcirculation and wound healing in the foot compared to~          before treatment (baseline) in patients with chronic wounds.~   "
33226|NCT02622295|"~     Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity,~     pressure ulcers, and cardiovascular disease at far greater rates than the general~     population. A rehabilitation method to prevent or reverse the systemic metabolic~     consequences of SCI is a pressing need. The purpose of this study is to determine the dose~     of muscle activity that can enhance an oxidative muscle phenotype and improve clinical~     markers of metabolic health and bone turnover in patients with SCI. The long-term goal of~     this research is to develop exercise-based interventions to prevent secondary health~     conditions such as diabetes and to ultimately protect health-related quality of life (QOL).~     Specific Aim 1: To compare changes in skeletal muscle gene regulation in individuals who~     receive high frequency (HF) active-resisted stance and low frequency (LF) active-resisted~     stance for 16 weeks. We Hypothesis 1: The expression of genes regulating skeletal muscle~     metabolism will support that HF and LF both instigate a shift toward an oxidative muscle~     phenotype. A novel finding will be that LF is a powerful regulator of oxidative pathways in~     skeletal muscle. Specific Aim 2: To compare changes in systemic markers of metabolic health~     and bone turnover in individuals with SCI who receive HF or LF for 16 weeks. Hypothesis 2:~     HF and LF will both reduce glucose/insulin levels and HOMA (homeostasis model assessment)~     score. However, only HF will demonstrate an effect on bone turnover (higher serum levels of~     osteocalcin). Secondary Aim: To measure subject-reported QOL using the EQ-5D survey metric.~     Hypothesis 3: HF and LF subjects will show a trend toward improved self-reported QOL after~     16 weeks. There will be an association between metabolic improvement and improved perception~     of QOL. These observations will support that this intervention has strong feasibility for~     future clinical translation.~   "
33227|NCT02622282|"~     The purpose of this study is to learn about the impact of text messaging on physical~     activity in persons with risk factors for peripheral arterial disease (PAD).~   "
33228|NCT02622269|"~     Compression of the abdomen during urography with either a patient-regulated compression~     device or conventional compression.~      Evaluation of radiation dose, image quality and patients' experiences~   "
33229|NCT02622256|"~     Cardiovascular (CV) disease is associated with significant morbidity and mortality. In the~     current digital age, needed is a better understanding of how information on social media~     sites may inform our approaches to improving CV health through novel methodologies.~     Investigators propose to study the conversation on Twitter about several CV diseases and~     their associated sequelae.~   "
33230|NCT02622243|"~     The study will assess the duration of protection of single doses of 2 different long acting~     muscarinic antagonists against methacholine induced bronchoconstriction.~   "
33231|NCT02622230|"~     The purpose of this study is to determine the safety and tolerability, and to evaluate the~     pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration~     in healthy adult subjects.~   "
33232|NCT02622217|"~     Sleep deprivation is common in anaesthesiology residents. Its effects on technical skills~     have been reported with controversial results. Non-technical skills (team working, situation~     awareness, decision making and task management) contribute to safe and efficient task~     performance. They have a crucial role in anaesthetic practice, especially during crisis~     management. The investigators hypothesized that sleep deprivation was associated with a~     reduced mobilisation of non-technical skills in anaesthesiology residents.~   "
33233|NCT02622204|"~     Our overall hypothesis is that a sudden ambulatory load reduction (caused by HTO) leads to~     changes in cartilage biology that delay or reverse osteoarthritic processes determining the~     clinical outcome and representing an in vivo model for assessing cartilage~     mechanosensitivity.~   "
33234|NCT02622191|"~     The investigators aims to further the understanding of glaucoma pathogenesis and progression~     by utilizing both enhanced depth imaging optical coherence tomography to visualize and~     measure the lamina cribrosa in vivo and segmentation technology to accurately delineate and~     measure the boundaries of the retinal layers. The investigators will elaborate further on~     the key concepts of lamina cribrosa thickness and transynaptic degeneration.~   "
33235|NCT02622178|"~     The main goal of this study is to evaluate the sensitivity and specificity of the NOVA-DN~     VEP protocol and a new software and method (Corda) for the glaucoma detection using optical~     coherence tomography images. Another objective is to evaluate the sensitivity and~     specificity of these tests to differentiate between normal subjects and glaucoma suspects.~      The hypothesis is that the NOVA-DN VEP protocol and Corda analysis results in a high~     sensitivity, specificity and area under the receiver operating characteristic (ROC) curves~     (ROC area) for the glaucoma detection. Another hypothesis is that the NOVA-DN VEP protocol~     and some Corda parameters can differentiate between normal subjects and glaucoma suspects.~   "
33236|NCT02622165|"~     The aim of this study is to conduct an outcome and process evaluation of the REWARD~     intervention, a serious game intervention using reward-based strategies as a main method to~     trigger healthy snacking in Flemish adolescents.~   "
33237|NCT02622152|"~     Directly following cardiac surgery for congenital heart disease; patients are not receiving~     routine turning every two hours to prevent pressure ulcers, because a negative influence on~     hemodynamic parameters is assumed. Investigators have suggested that lateral position may~     have clinically significant effects on oxygenation in cardiac surgery patients.~   "
33238|NCT02622139|"~     Monocentric, prospective interventional study to assess the degree of disease activity with~     a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's~     disease or ulcerative colitis.~   "
33239|NCT02622126|"~     Maternal hypotension is the most frequent complication of a spinal Anesthesia. The~     prevention of spinal hypotension appears more likely to decrease the frequency and severity~     of associated adverse maternal symptoms than the treatment of established hypotension.~     Intravenous fluid administration prior to spinal anesthesia for caesarean section is~     accepted standard practice. The choice of fluid depends on individual and institutional~     habit, material cost (crystalloid is considerably cheaper) and the perceived relative~     benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired~     coagulation. Although pregnancy is associated with hypercoagulability, little is known about~     the effects of colloid preloading on coagulation in pregnant patients.~   "
33240|NCT02622113|"~     This extension study was designed to evaluate the safety and efficacy of Canagliflozin~     (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The~     extension study was an extension to double-blind study of 16 weeks (TA-7284-11)~   "
33241|NCT02622100|"~     The purpose of this study is to evaluate the relative effectiveness and safety of~     Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.~   "
33242|NCT02622087|"~     The purpose of this study is to determine whether levels of sex hormones (including estrogen~     and progesterone) influence women's response to treatment for Specific Phobia of spiders. It~     is hypothesised that women will show less relapse of symptoms of spider phobia if they~     receive treatment during a period of high levels of sex hormones.~   "
33244|NCT02622061|"~     This is a multi-centre, single visit clinical investigation involving patients with known~     PCD vs. age matched healthy volunteers. This study involves 1 visit which will last one (1)~     to two (2) hours. Participants (and parent as applicable) will be asked for their consent to~     participate in the study. A brief medical history will be recorded, including information~     such as age, gender, height, weight, race, current medications and living environment. If~     the participant is a PCD patient, they will also be asked about their disease history. Prior~     to performing the nasal measurements, participants will receive instructions from study~     personnel and have the opportunity to practice. All participants will have a brief nasal~     exam and will also have to blow their nose before starting the measurements. Participants~     will be asked to perform nasal nitric oxide measurements using the tidal breathing method~     followed by the velum closed with expiration against resistance method.~      The primary objective is to determine the feasibility and capability of the NIOX VERO to~     discriminate participants with PCD from those that are healthy. Information collected in~     this study will help researchers understand more about the diagnosis of and identification~     of patients with PCD.~   "
33245|NCT02622048|"~     The purpose of this trial is to explore parent-child interactions in parents with and~     without psychosis, and ascertain whether a brief (10 week) supported self-help parenting~     program offered to parents in their own homes can help improve parents' self-efficacy and~     general well-being, as well as interpretations of their parent-child relationship and child~     behaviour in children who are 3-10 years old.~   "
33246|NCT02622035|"~     Background:~      We are involved in testing new behavioral science methods and measures for future research~     projects. In the course of these evaluations, we will also test research questions related~     to parents psychological experiences and how these relate to the responses they have when~     they encounter different types of communication about child health. We are testing multiple~     research questions in the course of this research.~      Objective:~      - To learn about technologies and approaches to use in future research studies.~      Eligibility:~      - Parents (fathers and mothers) of children between the ages of 3-7.~      Design:~      As part of the main study, participants will do four tasks:~      Task 1: Before participants arrive for an in-person visit, they will answer questions online~     about themselves, their child, and their thoughts and opinions related to health.~      Task 2: At the in-person visit, participants will watch a short scene from a movie and~     answer some questions~      Task 3: At the in-person visit, participants will read information about a child health~     topic and answer questions~      Task 4: At the in-person visit, participants will use a virtual reality-based buffet~     restaurant simulation to make hypothetical food choices for their child~   "
33247|NCT02622022|"~     36 patients with interstitial lung disease will be randomized to 1 weeks treatment with~     morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4~     times a day, or corresponding doses of placebo.~      VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other~     questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)~   "
33248|NCT02622009|"~     Background: The presence of low-grade viral infection in the airways of patients with stable~     chronic obstructive pulmonary disease (COPD) could potentially have implications in the~     pathogenesis and progression of the disease, but previous studies have reported very~     different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome~     detection in nasal and sputum samples. However, no study has investigated the presence of~     these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies.~     This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD~     patients by performing BAL and bronchial biopsies, and relate their presence with disease~     severity.~      Methods: Consecutive patients with stable COPD and control subjects, who underwent~     diagnostic (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy~     in a university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial~     biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with~     real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5΄~     non-coding region were searched for RSV and HRV detection, respectively.~   "
33249|NCT02621996|"~     The individual who is born premature, in addition to a CNS still in accelerated training~     suffers early loss of intrauterine restraint, conditions that promote hypotonia~     characteristic of premature birth. Given this hypotonia associated with musculoskeletal~     immaturity when improperly positioned in the incubator for an extended period, the PN can~     develop joint contractures and postural imbalances that, in most cases, are transitory,~     however can become persistent, causing delay in their Motor development. The aim of this~     study is to analyze the influence of the positioning of preterm infants in the incubator~     hammock on the tone and the myoelectric activity of the rectus abdominis flexor muscles,~     biceps and hamstrings. Study type controlled, randomized, double-blind, to be carried out~     from November 2015 to April 2016 will be obtained two groups, control (in containment nest~     U) and experimental (with hammock) to from randomized samples with premature births in~     Barao de Lucena Hospital or the Hospital das Clinicas, UFPE, the Intermediate Care Units~     (ICU) Neonatal. The sample will consist of 30 premature. To collect, pulse oximeter will be~     used, electromyography, neurological testing Dubowitz and recording behavioral responses.~     Each baby will be accompanied for about 8 hours daytime placement for two days and three~     evaluations performed.~   "
33250|NCT02621983|"~     This study will evaluate the ability of aerobic exercise to improve cognition in people with~     schizophrenia. Participants will be randomly assigned to one of two interventions: (1)~     aerobic exercise class (stationary bicycle, or spin class) for up to 45 minutes three~     times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three~     times per week for 12 weeks.~   "
33251|NCT02621970|"~     The investigators aim to evaluate the survival benefit from triple combination of induction,~     concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk~     locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated~     radiotherapy.~   "
33252|NCT02621957|"~     This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and~     without concomitant GDC-0810 administration in healthy female subjects of non-childbearing~     potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined~     in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be~     determined in the presence of GDC-0810.~   "
33253|NCT02621944|"~     Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates~     treated with the state of the art therapy (induced systemic hypothermia) have normal~     outcomes. Therefore, other promising therapies that potentially work in synergy with~     hypothermia to improve neurologic outcomes need to be tested. One potential agent is~     melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal~     gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has~     many other effects that may benefit infants with HI injury. Melatonin serves as a free~     radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes.~     Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in~     turn minimizing cell death and improving outcomes. The research study will evaluate the~     neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing~     therapeutic hypothermia for hypoxic ischemic encephalopathy.~   "
33254|NCT02621931|"~     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with~     chronic migraine~   "
33255|NCT02621918|"~     We aimed to investigate the effect of a progressive resistance training and aerobic training~     protocol on functional capacity, body composition and quality of life.~   "
33256|NCT02621905|"~     The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring~     anti-fungal prophylaxis or therapy. The present study is designed to compare the~     pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The~     3-week exposure to each formulation is designed to allow for all participants to reach~     steady-state for each drug, as the time to steady-state can vary.~   "
33257|NCT02621892|"~     This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will~     evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant~     irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active~     disease as determined after a two-week screening period. Subjects who qualify and are~     randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12~     week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.~   "
33258|NCT02621723|"~     CURIOS@ is a prospective multi-centre cross-sectional study to investigate readmissions in~     participating units. The data collected is derived from two clinical episodes: the episode~     containing the re-admission and the previous admission (index admission).~      The main aims are:~      Outcomes:~        -  Risk factors to predict preventable readmissions in non-surgical patients~        -  Percentage of subjectively non-preventable and preventable readmissions from patient,~          carer, their nurses and their physician's point of view~        -  Comparison for risk factors on readmissions throughout Europe~        -  Increasing awareness and knowledge for health-care workers on readmissions and its~          preventability~   "
33259|NCT02621710|"~     This study evaluates patient goal achievement and satisfaction in benign hysterectomy.~     Patient's will state their goals prior to undergoing benign hysterectomy, and will receive a~     follow-up questionnaire 3 months post-operatively evaluating their perception of goal~     achievement and overall satisfaction. Goal achievement and satisfaction will be evaluated~     for association with surgical indication, surgical approach (minimally invasive vs abdominal~     surgery), and demographic information.~   "
33260|NCT02621697|"~     Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task)~     in the risk of falls, balance, independence in basic activities of daily living (BADL) and~     handgrip in institutionalized elderly.~      Methods: The sample was divided in two groups: double task group (DTG), consists of five~     elderly, undergoing a training consists of motor and cognitive activities and control group~     (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based~     on global stretching and strengthening exercises, both held in 16 sessions.~   "
33261|NCT02621684|"~     The purpose of this pilot study is to evaluate the feasibility of recruiting African~     American prostate cancer survivors to a 12 week physical activity intervention study of~     three arms (aerobics, resistance training, and usual care) through physician referral and~     community advertisement strategies. In addition, the investigators will investigate the~     acceptance rate of the intervention and gather preliminary results on the effect of exercise~     on African American men's urinary and sexual functions. These data can then be used to~     refine the intervention and its implementation model, and to inform the submission of a~     larger grant to the National Institutes of Health.~   "
33262|NCT02621671|"~     Epidemiology seeks to improve public health by identifying risk factors for cancer and other~     diseases and conveying that information to relevant audiences. The audience is presumed to~     understand and use that information to make appropriate decisions about lifestyle behaviors~     and medical treatments. Yet, even though a single risk factor can affect the risk of~     multiple health outcomes, this information is seldom communicated to people in a way that~     optimizes their understanding of the importance of engaging in a single healthy behavior.~     Providing individuals with the ability to understand how a single behavior (obtaining~     sufficient physical activity) could affect their risk of developing multiple diseases could~     foster a more coherent and meaningful picture of the behavior's importance in reducing~     health risks, increase motivation and intentions to engage in the behavior, and over time~     improve public health.~      The proposed study translates epidemiological data about five diseases that cause~     significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart~     disease, diabetes, and stroke) into a visual display that conveys individualized risk~     estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.~   "
33276|NCT02621489|"~     The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize~     vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI)~     and to accelerate stent endothelialisation.~   "
33277|NCT02621476|"~     The investigators propose a randomized encouragement trial to encourage use of the existing~     mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor~     medications in 3 health care systems: Kaiser Permanente Northern California, Harvard~     Pilgrim, and Kaiser Permanente Hawaii.~   "
33278|NCT02621463|"~     Conduct human trials in the endoscopy suite of our continuous positive airway pressure~     (CPAP) ventilator approach using an FDA approved ventilator.~   "
33447|NCT02619266|"~     This trail will be carried out to evaluated the effect and safety of acupuncture for the~     anorexia in patients with gastrointestinal tract and lung cancers.~   "
33263|NCT02621658|"~     Colorectal cancer is the third most common cancer diagnosed in both men and women in the~     United States. The death rate from this disease, however, has been decreasing over the last~     20 years. Early detection and removal of pre-malignant polyps is considered to be at the~     core of this change. At the same time, polyp detection is highly dependent on an adequate~     bowel preparation. Froehlich, et al., found that poor bowel preparation is associated with~     longer colonoscopy times, more difficult procedures and a higher rate of incomplete~     procedures(2).~      Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation~     regimes, several studies have shown similar results with less restrictive diets.~      Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid~     Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to~     compare these dietary interventions. The investigators and endoscopists will be blinded to~     patient's diet group.~      Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is~     associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD).~     Investigators will compare the performance of these dietary interventions regarding adenoma~     detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In~     addition, the investigators want to assess whether patient's Compliance and Satisfaction is~     similar or superior in the experimental group vs the control group.~   "
33264|NCT02621645|"~     Multi-center open-label randomized controlled trial to assess if early intervention~     (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late~     intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women~     diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late~     intervention group (1:1), using a web-based application and a computer-generated list with~     random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational~     age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by~     intention to treat.~   "
33265|NCT02621632|"~     The study intends to investigate a novel compression system termed Socknleg composed of an~     understocking covering the foot with three added stockings extending from the ankle to the~     knee without covering the foot. The novel Socknleg system is compared to a standard class~     III compression stocking.~   "
33266|NCT02621619|"~     To determine the efficacy of IV acetaminophen as an analgesic adjunct to IV hydromorphone in~     the treatment of acute severe pain in the elderly ED patients.~   "
33267|NCT02621606|"~     The purpose of this open-label, 3-part study is to investigate the safety and efficacy of~     [11C]MK-6884 as a Positron Emission Tomography (PET) imaging agent for quantifying~     muscarinic 4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of~     interest. The study will enroll healthy participants (Parts I and II) and participants with~     Alzheimer's Disease (AD)(Part III). The primary efficacy hypothesis is that the average~     intra-subject test-retest (T-RT) variability of tracer uptake in brain regions of interest~     is ≤20%.~   "
33268|NCT02621593|"~     The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction~     (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction~     in dry eye symptoms post-treatment, compared to pre-treatment.~   "
33269|NCT02621580|"~     Laser therapy is an established method to stabilize and control proliferative diabetic eye~     disease. Questions on the long-term effect on the retina from these treatments remain to be~     answered. The purpose of the study was to evaluate changes in the retina following~     panretinal photocoagulation (PRP) over time, using structural and functional diagnostic~     tests.~   "
33270|NCT02621567|"~     Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute~     Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to~     assess the feasibility of conducting a full trial which would assess the efficacy of Bright~     Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary~     syndrome.~   "
33271|NCT02621554|"~     The study will investigate whether resveratrol could provide positive effects on memory and~     brain structures and functions in healthy elderly participants.~   "
33272|NCT02621541|"~     Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine~     tumors (NF P-NET) remains a difficult problem in clinical practice. At present, the~     treatment planning in P-NET is significantly restricted by the limited results of~     conventional imaging. In addition, increasing use of multidetector computed tomography~     (MDCT) and magnetic resonance imaging (MRI) is increasing the number of NF P-NETs detected.~     Somatostatin receptor scintigraphy (SRS) combined with anatomical imaging are the~     conventional modalities in imaging of P-NET, but by these methods the diagnostic accuracy~     still remains compromised. Furthermore, recently encouraging results have been obtained in~     P-NET using 68Ga-labelled somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC)~     positron emission tomography-computed tomography (PET-CT).~      The aim of the current project is to evaluate the possibility to enhance the diagnostic~     accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG)~     and 68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients~     with NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG~     PET-CT followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The~     data will be collected between autumn 2015 and spring 2018.~   "
33273|NCT02621528|"~     The purpose of this multi-center, interventional, prospective, post-market study is to~     collect real world data on patient outcomes and evaluate the procedural success and~     performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial~     Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).~   "
33274|NCT02621515|"~     The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2~     clinical trial will be the first to evaluate this intracranial effect in humans, with the~     aim to give these patients the possibility to be treated with anti-PD-1. Besides the~     objective response rate, long term benefits in this patient category will be evaluated by~     measuring survival in terms of progression free survival and overall survival. Furthermore~     safety and tolerability of administration of this drug in patients with symptomatic brain~     metastases will be studied, as this is the first study for nivolumab in this specific~     patient category.~   "
33275|NCT02621502|"~     The purpose of this study is to to assess the glycemic index and the satiating properties of~     different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight~     subjects.~   "
33279|NCT02621450|"~     End stage renal disease (ESRD) is related with increased cardiovascular mortality and~     morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among~     hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of~     low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by~     ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis~     treatment.~      Methods: The study will be included 46 patients who had creatinine clearance levels less~     than 10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the~     enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium~     dialysate for six months via computer-generated randomization.~   "
33280|NCT02621437|"~     Breast cancer can be painful following surgery or can develop later and remain persistent.~     Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity~     with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan~     is to preserve quality of life.~      Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease,~     treatments and their side effects (asthenia, anxiety and pain).~      The main objective is to assess the impact of osteopathic treatment on pain in patients~     following breast cancer surgery. The impact will be considered beneficial if the pain score~     (digital scale) in the intervention group is lower, by at least two points, than the pain~     score in the control group at the end of the study.~      This is a monocentric, randomized, parallel group, single-blind and prospective clinical~     trial.~   "
33281|NCT02621424|"~     The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS)~     improves cognitive function in patients with neurodegenerative conditions which may manifest~     as mild to moderate cognitive impairment and, in late phase, dementia. This study also~     intends to investigate if the responses to rTMS intervention are either positively or~     negatively correlated with the initial severity of cognitive impairment.~   "
33282|NCT02621411|"~     Substance abuse is a growing problem world wide, and treatment of substance abusers in the~     perioperative period, especially for emergency operation is challenging. The objectives of~     this study are to determine the proportions of substance abusers in the trauma patients~     undergoing emergency operation by preoperative screen, observe the differences of~     consumption of anesthetics and other medications during perioperative period between~     substance abusers and non-abusers, as well as postoperative complications, and explore an~     optimal scheme for substance abusers.~   "
33283|NCT02621398|"~     This phase I trial studies the side effects, best dose, and best way to give pembrolizumab~     when given together with paclitaxel, carboplatin, and radiation therapy in treating patients~     with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and~     shrink tumors. Giving pembrolizumab together with paclitaxel, carboplatin, and radiation~     therapy may kill more tumor cells.~   "
33284|NCT02621385|"~     This study is designed to evaluate the potential effect of administration of tradipitant on~     CYP3A4 using midazolam pharmacokinetics as markers.~      The study will also further characterize the pharmacokinetics of tradipitant.~   "
33285|NCT02621372|"~     Portal hypertension is a common complication of liver cirrhosis that can lead to development~     of esophageal varices (EV). They are abnormally dilated veins within the wall of the~     esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV~     at some point, and about third of these patients will have at least one bleeding episode~     because of rupture of a varix . For this reason, screening endoscopy for detection of the~     presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is~     a very important preventive step for identification of those patients with variceal bleeding~     risk and furthermore, identification of patients in urgent need for prophylactic treatment.~      All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients~     with portal hypertension. However this approach is limited by its invasiveness and cost~     effectiveness issues of screening endoscopy .~   "
33286|NCT02621359|"~     Helicobacter pylori (H. pylori) infection is a global health problem as it is associated~     with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.~      Therefore, the eradication of the pathogen is of critical importance to reduce H.~     pylori-related complications .~      However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has~     become more challenging. With a great decline in the eradication rate of standard triple~     therapy for Helicobacter pylori to below 70% in many countries.~      Treatment with triple therapy, which is the most frequently recommended, fails to eradicate~     H. pylori in approximately 20% of cases .~   "
33287|NCT02621346|"~     Mental imagery is effective for improving motor skills as well as increasing muscles~     strength and size. Strength is also maintained after immobilization of a muscles when~     engaging in imagery. This may have important implications for rehabilitation settings and~     for sedentary individuals. We may not be able to get people wot exercise but if they can~     maintain muscles size and strength via imagery this may have beneficial health and~     functional outcomes.~   "
33288|NCT02621333|"~     This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy~     of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung~     adenocarcinoma.~   "
33289|NCT02621320|"~     There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as~     well as wheelchair users, vitamin D deficiency occurs even more often. It is well~     established that vitamin D deficiency has a negative effect on health. However, vitamin D~     supplementation in individuals with a vitamin D deficiency has a positive effect on muscle~     performance. In recently published studies with able-bodied subjects, it has been shown that~     a normal vitamin D level (>75nmol/L) can only be achieved with a high-dose supplementation~     of vitamin D.~      The aim of this study is to examine the effect of vitamin D supplementation on exercise~     performance in wheelchair athletes with vitamin D deficiency . All participants with a~     vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of~     vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D~     level will receive placebo treatment (control group). The physical performance is measured~     three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate~     and a dynamometer test.~   "
33292|NCT02621281|"~     This is a multi-centers prospective, randomized, controlled trial. This trial will~     investigate the clinical outcome of kidney transplant recipients whose kidneys are under two~     different forms of organ preservation--hypothermic machine perfusion vs. static cold~     storage. Factors during the machine perfusion, such as the pressure, flow rate, and~     resistance index will also be investigated.~   "
33293|NCT02621268|"~     Determine if ICG administered pre-operatively, then imaged intraoperatively using our~     cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph~     nodes and satellite nodules during minimally invasive procedures. The investigators intend~     on enrolling 48 Subjects in this study. The study is focusing on patients presenting with~     suspected thoracic cancers who are considered to be good minimally invasive surgical~     candidates~   "
33294|NCT02621255|"~     Investigator' s study designed to investigate effect of general and regional anesthesia on~     fracture healing.The 40 age and older ASAI-III patients who will operate due to femur~     fracture (except femur neck fracture) will be enrolled in this study after informed consent~     approval.~      Subjects will be divided into two groups by a computerized randomization method. 40 patients~     will be enrolled in this study. General anesthesia will perform for 20 patients. Regional~     anesthesia will perform for 20 patients. Preoperative, 4. week and 12. weeks laboratory test~     which include blood and urine β-C terminal telopeptid (β-CTX), blood alkaline phosphatase~     and osteocalcin will test for all patients. All patients will not use nonsteroid~     anti-inflammatory drugs during study neither perioperative nor postoperative periods.~     fracture healing will be asses with clinical evaluation and laboratory tests.~   "
33295|NCT02621242|"~     As explained in detail in a recently published hypothesis article (Hladik F. A new~     hypothesis on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI~     drugs may reduce the likelihood of HIV eradication by promoting the survival of cells with~     integrated provirus. In this study, the investigators will test whether daily oral use of~     two NTRI drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and~     lower gut mucosa that are congruent with supporting this hypothesis.~   "
33296|NCT02621229|"~     The purpose of this multi-center randomized controlled trial is to compare lower calorie~     refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN.~     The investigators will compare efficacy (achievement and maintenance of clinical remission~     at 12 months), safety during hospitalization, and cost effectiveness (including costs of~     initial and re hospitalization, 12 month follow up and safety/adverse events).~   "
33297|NCT02621216|"~     Background of the study:~      Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary~     artery disease and the number of patients receiving PCI is vastly growing. However,~     relatively little long-term follow-up studies of large real-world clinical samples exist~     that have looked at the real-world effects of PCI treatment and adherence to current~     guidelines.~      Psychological risk factors are important in determining prognosis after PCI, and undergoing~     PCI may increase the risk of low mood. To date, studies have examined single psychological~     risk factors, without taking into account their relatedness. Moreover, guidelines are~     advocating psychosocial screening in early cardiovascular disease, but the screening test as~     proposed in the prevention guideline has not yet been validated or tested. Although the~     detrimental effects of psychological risk factors on cardiovascular prognosis are known, the~     mechanisms through which they exert these effects are yet unclear. It is to be expected that~     not one but multiple biological (inflammation, endothelial dysfunction) and behavioural~     (coping styles, poor self-care, consultation behaviour) pathophysiological processes play a~     role, and that these processes interact with each other. In PCI patients the mechanisms~     linking psychological risk to poor prognosis are still to be investigated.~      Objective of the study:~        1. To examine the adherence to the prevention and PCI guidelines and the effects thereof~          on long term prognosis in PCI patients.~        2. To evaluate the effectiveness of the psychosocial screening instrument of the European~          Society of Cardiology Prevention guideline 2012.~        3. To examine effects of clustering psychological risk factors on several networks of~          potentially mediating mechanisms and long term outcomes in a large sample of PCI~          patients.~   "
33298|NCT02621203|"~     A multicentre, prospective, observational, hospital-based registry of patients with acute~     heart failure (AHF) those whose care was guided by a cardiologist in Turkey.~   "
33299|NCT02621190|"~     After failure on docetaxel, which has been the standard first line therapy for patients with~     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are~     currently available. In retrospective studies, resistance has been described to two of the~     treatment options, enzalutamide and abiraterone, when a splice variant of the Androgen~     Receptor (AR-V7) is present on circulating tumor cells (CTCs). The investigators hypothesize~     that patients with AR-V7 positive CTCs do have a meaningful response to cabazitaxel.~   "
33300|NCT02621177|"~     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of~     the study is to describe the immunogenicity and safety of the trivalent cell culture-derived~     influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.~   "
33301|NCT02621164|"~     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of~     the study is to describe the immunogenicity and safety of the quadrivalent cell~     culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine~     among subjects.~   "
33302|NCT02621151|"~     This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation~     and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are~     not candidates for or decline radical cystectomy.~   "
33303|NCT02621138|"~     Population:~      16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.~      All children aged 6-12 yrs who understand simple commands.~      Tools:~        1. Polar monitor to record heart rate, attached to chest, in use throughout testing~        2. Dynamometer- for assessing muscle strength.~        3. Weights~      Method:~      Each child will be tested once. Both tools will be demonstrated and tried out before actual~     testing.~      With Polar watch attached:~        1. 5 min sitting at rest,~        2. knee muscle strength assessment with the dynamometer,~        3. 15 minutes rest~        4. Isometric and isotonic knee muscle contraction at 30% of childs` maximal strength as~          has assessed by the dynamometer. The child will asked to perform each for 3 minutes,~          with 5 minutes rest in-between All will be perform in both legs.~   "
33304|NCT02621125|"~     This is a double blind, randomized, placebo controlled clinical trial to test the efficacy~     of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men~     diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)~   "
33335|NCT02620722|"~     This study evaluates a novel technique for measuring the minimum pressure necessary to~     achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP).~     Patients will have tourniquets applied to their arms and legs and LOP will be measured using~     the new technique and a gold standard Doppler ultrasound technique.~   "
33305|NCT02621112|"~     Hepatitis B virus infection remains an important clinical issue among patients on renal~     replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after~     intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated~     with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low~     hepatitis B vaccine dose. Various small-scale studies including multiple high dose~     intramuscular vaccination or multiple small dose intradermal vaccination were attempted with~     variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a~     novel intradermal microneedle has demonstrated good immunogenic responses similar to~     full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the~     treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The~     investigators therefore propose a prospective, randomized study to compare the safety and~     immunogenicity of intradermal hepatitis B vaccination with this novel device with~     intramuscular in patients on renal replacement therapy.~   "
33306|NCT02621099|"~     A novel hand held hybrid optical-gamma camera (hereinafter referred to as the camera) has~     been developed and can be used to image radiotracer distribution at the patient bedside.~     This study aims to evaluate the imaging capabilities of the camera in patients attending~     surgery for sentinel lymph node biopsy (SLNB) procedure. It is anticipated that this could~     improve the accuracy and simplify sentinel lymph node detection by providing fused optical~     and gamma imaging.~   "
33307|NCT02621086|"~     This is an initial pilot study to assess and investigate if any adverse symptoms occur (and~     also the severity of any symptoms) after consuming a food-grade Cellodextrin preparation.~     Volunteers will attend a short (around 30mins) medical screening visit, to make sure they~     are suitable to take part in the study. They will then attend 4 study visits (separated by~     at least a week) for around 9.5 hours each time. During the study visits 10, 20, 30, or 50g~     of Cellodextrin will be given as a single oral dose, in a milkshake drink, and any symptoms~     experienced will then be monitored via questionnaires during the study day and for the next~     60 hrs, dietary intake will also be measured over this time.~   "
33308|NCT02621073|"~     To answer the question: Do Prontosan instillations decrease time to wound and fracture~     healing and decrease bacterial load compared to wound vac treatment without Prontosan?, we~     will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial.~     The subjects will be split equally into two different groups by randomization. One groups~     will have wound vac therapy with Prontosan, and one group will have wound vac therapy~     without Prontosan. Data related to wound and fracture healing and bacterial load will be~     assessed between the two groups to determine if wound vac therapy with Prontosan speeds up~     healing time and decreases bacterial load.~   "
33309|NCT02621060|"~     Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control,~     obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show~     that Chlorogenic acid has an excellent potential for the control of glucose as well as~     insulin secretion and insulin sensitivity.~   "
33310|NCT02621047|"~     This is a multicenter, non-randomized, single-dose, open-label study conducted in male and~     surgically sterile or post-menopausal female participants with stable chronic hepatic~     impairment and in healthy participants matched by age, gender, and body weight to assess the~     effect of hepatic impairment on the pharmacokinetics of alectinib.~   "
33311|NCT02621034|"~     In this study the investigators aim to compare the post-operative pain using two single-file~     endodontic rotary systems : Reciproc and One shape.~   "
33312|NCT02621021|"~     Background:~      Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating~     lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are~     returned to the person. Researchers think adding the drug pembrolizumab might make the~     therapy more effective.~      Objective:~      To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma~     tumors.~      Eligibility:~      People ages 18 70 years with metastatic melanoma~      Design:~      Participants will be screened with:~      Physical exam~      CT, MRI, or PET scans~      X-rays~      Heart and lung function tests~      Blood and urine tests~      Before treatment, participants will have:~      A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells~      Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white~     blood cells.~      The rest of the blood returns through a needle in the other arm.~      An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if~     assigned)~      Participants will stay in the hospital for treatment. This includes:~      Daily chemotherapy for 1 week~      For some participants, pembrolizumab infusion 1 day after chemotherapy~      TIL cell infusion 2 4 days after chemotherapy, then aldesleukin infusion every 8 hours for~     up to 12 doses~      Possible filgrastim injection~      Recovery for 1 2 weeks~      After treatment, participants will:~      Take an antibiotic and antiviral for at least 6 months~      If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have~     another round.~      Have 2-day follow-up visits every 1 3 months for 1 year and then every 6 months~   "
33313|NCT02621008|"~     A self administered 16 weeks plus follow up study to explore the efficacy of mobile phone~     driven apps for stress reduction coupled with guidance for healthy living among obese and~     overweight populations. The Study primary end points are weight of the participants, as well~     as glucose measurements (for subject with diabetes) and blood pressure (of subjects with~     hypertension).~   "
33314|NCT02620995|"~     The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on~     penile and systemic microvascular function as well as in blood pressure.~      A control group of normotensive age-matched healthy subjects will serve as a comparator~     group for normal penile and systemic microvascular function.~   "
33315|NCT02620982|"~     This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock~     wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of~     vasculogenic origin.~   "
33361|NCT02620384|"~     The primary objective of the study is to determine efficacy of metolazone as synergistic~     therapy with Lasix in patients with acute decompensated heart failure. This will be a single~     center double blinded randomized placebo- controlled pilot study of the addition of 5 mg of~     metolazone per day for 2 days compared to placebo in patients admitted with acute~     decompensated heart failure.~   "
33316|NCT02620969|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide~     the clinician with new diagnostic and therapeutic tools for the management of children with~     CKD, based on the improved understanding of uraemic toxicity.~      In the first part of UToPaed, the investigators will associate concentrations of a wide~     variety of uraemic toxins with different comorbidities in CKD children. In this second part,~     a kinetic analysis will be performed to unravel the distribution and transport of the~     different studied uraemic toxins in the body of the patient. The toxins of which~     concentrations are best correlated with comorbidities during the progress of CKD (UToPaed -~     part 1: observational study) and have representative kinetics will be selected as markers.~     These markers will be, together with the comorbidities, further tracked after interventions,~     i.e. starting on dialysis, transplantation, changes in dialysis strategy (UToPaed - part 3 -~     intervention study) in order to validate the different kinetic models.~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of~     all children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
33317|NCT02620956|"~     BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of~     radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after~     inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA)~     with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a~     vibrating mesh inhaler.~   "
33318|NCT02620943|"~     Background: Maternal and child under-nutrition is the underlying cause of death for millions~     across the globe. Anemia during pregnancy is among the leading nutritional disorders with~     serious short and long term consequences to both the mother and fetus.~      Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status~     and key pregnancy outcomes of pregnancy.~      Methods: A prospective cohort study design, involving a total of 432 eligible pregnant~     women, in their second antenatal care visit was conducted between August 2014 to March,~     2015. The individual dietary diversity Score (IDDS) was used as the exposure variable to~     select, enroll and follow the mothers. Epi-data, SPSS and STATA software are used to enter~     and analyze the data. Chi-square test, independent 't'-test, and GLM are used to calculate~     risk, association and differences between key variables at P < 0.05~   "
33319|NCT02620930|"~     DASAP-HF is an observational prospective single arm study. All patients will be treated~     according to the standard care followed by each center. The protocol requires enrollment of~     consecutive patients from each center, according to eligibility criteria. All patients must~     sign the Patient Informed Consent (PIC) before the enrollment in the study. All patients,~     after the enrollment phase, will be followed for 24 months. Approximately every 12 months a~     clinical follow-up procedure should be performed in each patient. A sleep study will be done~     in all patients at 1 month (or at 3 months) from the enrollment, in order to evaluate the~     performance of the algorithm as a diagnostic tool in this population (primary objective).~     During the 24 months follow-up period, all Adverse Events occurred in the study population~     will be collected (HF hospitalizations, all-cause deaths, ventricular arrhythmias, etc.). At~     the end of the 24 months follow-up, the incidence of clinical events will be evaluated as~     well as its association with the Respiratory Disturbance Index (RDI) values calculated by~     APNEA Scan algorithm (secondary objective).~   "
33320|NCT02620917|"~     This is an observational, multicenter, cross sectional study, collecting clinical and~     metabolic informations about patients treated with CSII in Italy.~   "
33321|NCT02620904|"~     Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or~     placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational~     age or greater.~      Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when~     compared to placebo, and in conjunction with other pharmacologic methods for induction of~     labor.~      Expected outcomes: The addition of a progesterone receptor modulator will expedite time to~     delivery of the fetus and ultimately improve the experience associated with induction of~     labor for fetal demise.~   "
33322|NCT02620891|"~     Helium—oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome~     in previous studies，but the evidence was limited．The aim of the study was to assess the~     effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70%~     helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in~     meconium aspiration syndrome.~   "
33323|NCT02620878|"~     The purpose of this study is to determine safety, feasibility and efficacy (with respect to~     sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night~     closed-loop control in children and adolescents with type 1 diabetes.~   "
33324|NCT02620865|"~     This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed~     activated T-cells when given together with aldesleukin and sargramostim and to see how well~     they work in treating patients with pancreatic cancer that has spread from where it started~     to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic).~     Bispecific antibody armed activated T-cells are the patient's own T cells that are coated~     with a bispecific antibody comprising 2 antibodies chemically joined together. These~     antibodies have specific targets and binding properties that may give the T cells a greater~     ability to seek out, attach to, and kill more cancer cells.~   "
33336|NCT02620709|"~     This project is a community-engaged, randomized control trial of hula, the indigenous dance~     form of Native Hawaiians (NH), among 250 NHs with hypertension living in Hawaii and~     Washington State. Investigators will compare the effects of a 6-month intervention, called~     the KaHOLO Program, delivered by trained peer educators to a wait-list control condition on~     blood pressure and 10-year cardiovascular risk. The intervention will be comprised of hula~     plus hypertension self-care education program. Investigators will also examine the mediating~     effects of health behaviors, self-regulation, psychosocial, and socio-cultural factors on~     blood pressure reduction. The ultimate goal is to develop and test a culturally-appropriate,~     acceptable, and effective intervention that can be delivered and sustained in community~     settings.~   "
33325|NCT02620852|"~     Most physicians still use a one-size-fits-all approach to breast screening in which all~     women, regardless of their personal history, family history or genetics (except BRCA~     carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit~     women by detecting cancers early when they are easier to treat, but they are not perfect.~     Recent news stories have discussed some of the potential harms: large numbers of positive~     results that cause stressful recalls for additional mammograms and biopsies. With the~     current screening approach, half of the women who undergo annual screening for ten years~     will have at least one false positive biopsy. Potentially more important are cancer~     diagnoses for growths that might never come to clinical attention if left alone (called~     overdiagnosis). This can lead to unnecessary treatment. Even more concerning is evidence~     that up to 20% of breast cancers detected today may fall into the category of~     overdiagnosis.~      This proposal compares annual screening with a risk-based breast cancer screening schedule,~     based upon each woman's personal risk of breast cancer. The investigators have designed the~     study to be inclusive of all, so that even women who might be nervous about being randomly~     assigned to receive a particular type of care (a procedure that is typical in clinical~     studies) will still be able to participate by choosing the type of care they receive.~      For participants in the risk-based screening arm, each woman will receive a personal risk~     assessment that includes her family and medical history, breast density measurement and~     tests for genes (mutations and variations) linked to the development of breast cancer. Women~     who have the highest personal risk of developing breast cancer will receive more frequent~     screening, while women with a lower personal risk would receive less frequent screening. No~     woman will be screened less than is recommended by the USPSTF breast cancer screening~     guidelines.~      If this study is successful, women will gain a realistic understanding of their personal~     risk of breast cancer as well as strategies to reduce their risk, and fewer women will~     suffer from the anxiety of false positive mammograms and unnecessary biopsies. The~     investigators believe this study has the potential to transform breast cancer screening in~     America.~   "
33326|NCT02620839|"~     This is a Phase Ib dose escalation / expansion study with the combination of alpelisib and~     weekly cisplatin. Dose escalation will follow standard 3+3 design. During dose escalation,~     two dose levels of weekly cisplatin (30 and 35 mg/m2, respectively) will be evaluated in~     combination with escalating doses of alpelisib in parallel. Cohort B (cisplatin 35 mg/m2) at~     a given dose level of alpelisib to open only after corresponding A cohort (cisplatin 30~     mg/m2) at the same dose level of alpelisib has cleared DLT window. Cohorts A and B may~     enroll in parallel (e.g., Cohort 3A may enroll in parallel with Cohort 2B) as shown below in~     the dose escalation schema. Intermediate dose levels and alternative dosing schedules may be~     investigated per the discretion of Principal Investigator using same 3+3 dose escalation~     schema (e.g. cisplatin administered days 1, 8 of 21 day cycle).~   "
33327|NCT02620826|"~     This prospective study compares the use of indirect pulp therapy and mineral trioxide~     aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the~     pulp.~   "
33328|NCT02620813|"~     There are two purposes of this study:~        1. First, the investigators want to see what the differences are in de novo sebaceous~          lipid production of people with and without acne.~        2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid~          production before and after treatment with topical tretinoin and oral isotretinoin.~   "
33329|NCT02620800|"~     The purpose of this study is to learn about the safety and potential benefit of metronomic~     5-fluorouracil in combination with nab®1-paclitaxel, bevacizumab, leucovorin, and~     oxaliplatin in treating patients with metastatic pancreatic adenocarcinoma.~   "
33330|NCT02620787|"~     This study will determine the tissue penetration of tedizolid (Sivextro, Merck & Co.), a~     novel oxazolidinone antibiotic, into the extracellular, interstitial fluid of soft tissue in~     diabetic patients with lower limb wound infections. Penetration will be compared with a~     group of healthy volunteer control participants.~   "
33331|NCT02620774|"~     This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck &~     Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular,~     interstitial fluid of soft tissue in diabetic patients with lower limb wound infections.~     Penetration will be compared with a group of healthy volunteer control participants.~   "
33332|NCT02620761|"~     The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial~     with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon~     a difference in serum creatinine by one standard deviation. Fluid and salt intake will be~     held constant within clinical parameters and carefully measured. Fenoldopam will be started~     at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be~     increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the~     study. A study of pediatric patients previously provided to the FDA showed no hypotension at~     a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of~     indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will~     include both blood and urine. The primary outcome will be a reduction in renal dysfunction,~     as determined by creatinine and urine output over the course of treatment. Additional~     outcomes will include determination of known and novel metabolomic urine markers of renal~     dysfunction.~   "
33333|NCT02620748|"~     The purpose of this study is to determine the effect of the early administration of~     intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured~     intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb),~     and frequency of blood transfusions) in women undergoing a myomectomy.~   "
33334|NCT02620735|"~     While physical activity (PA) appears to play an important role in disease control and the~     promotion of long-term health and well-being of cancer survivors, the large majority of~     breast cancer survivors are not physically active. Addressing this problem requires exercise~     promotion and an additional method of supporting long term exercise adherence. In response,~     an innovative health coaching intervention which uses mobile technology (iMOVE) to promote~     long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107~     inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL)~     OR a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting~     of telephone-based coaching sessions and interactive software delivered through a~     smart-phone and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the~     feasibility and acceptability of the methods and intervention and examine the impact on~     fitness (primary), patient-reported, anthropometric, and physical (secondary) outcomes will~     be collected. Impact and relevance: PA has increasingly been identified as a modifiable~     factor that has the potential to impact cancer outcomes and improve quality of life. iMOVE~     is an innovative intervention with the potential to promote and maintain physical activity~     for breast cancer survivors. This study will be the first step in the evaluation of iMOVE~     and will help to determine whether a larger randomized controlled trial is needed.~   "
33362|NCT02620371|"~     This study aims to compare the analgesic efficacy and safety of local bupivacaine alone~     versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients~     undergoing breast cancer surgery.~   "
33337|NCT02620696|"~     Hypergastrinaemia induced by proton pump inhibitor (PPI) treatment is reported to cause~     ECL-cell and parietal-cell hyperplasia, and rebound hyperacidity and dyspepsia after PPI~     withdrawal.~      The objective of the study was to determine the dosage regimen of netazepide, a gastrin/CCK2~     receptor antagonist, required to inhibit the trophic effects of PPI-induced~     hypergastrinaemia.~      Six groups of 8 healthy subjects participated in a randomised, double-blind,~     placebo-controlled exploratory study of esomeprazole 40 mg daily for 28 days, and netazepide~     1, 5 or 25 mg, or placebo daily during the last 14 days of esomeprazole dosing, or 14 days~     after esomeprazole withdrawal. Serum gastrin and plasma chromogranin A (CgA) were measured~     regularly from study start until at least 1 week after the last dose. Dyspepsia was~     monitored after esomeprazole withdrawal.~   "
33338|NCT02620683|"~     Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral~     injection reduces time of onset, results in a deeper anesthetic effect, without the sting~     with injection from a low pH. Additional data are needed to establish clinical important~     outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug~     combination.~      Clinical pilot studies are proposed as the start of a series of investigations to support or~     modify the use of the buffered anesthetic for intraoral procedures.~   "
33339|NCT02620670|"~     Obesity is a major public health problem on the world and Mexico too, in addition the~     obesity develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus~     (T2DM) and cardiovascular disease (CVD). So the phenomenon of obesity is studied in many~     investigations to know their causes, prevention and treatment.~      Participation of body fat and especially in the visceral area is well documented in the~     appearance of T2DM; however, it is quite interesting that found that not all individuals~     with visceral obesity have impaired glucose tolerance, prediabetes or T2DM; but they are~     presented as normoglycemic individuals with obesity.~      Currently, it is recognized that physical activity influences the concentrations of plasma~     glucose, and promoting their utilization in peripheral tissues, to be used as an energy~     source, through the regulation of glucose transporters in tissues such as the muscle, so~     might influence the glycemic variability, and therefore is of interest to this study to~     evaluate the effect of physical activity of moderate intensity on the glycemic variability~     of individuals with visceral obesity and normal weight without alterations in tolerance~     glucose.~   "
33340|NCT02620657|"~     Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria,~     will be recruited by 30 sites in North China.~   "
33341|NCT02620644|"~     Neuroretinal damage in diabetes produces functional abnormalities such as the loss of~     chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be~     detected by means of electrophysiological studies in diabetic patients with diabetes~     duration of less than two years, i.e. before microvascular lesions can be detected in~     ophthalmologic examination. Neurodegeneration seems to be a generalized process that occurs~     throughout the macula and is not confined to local abnormalities, in the cases with visible~     signs of retinopathy.~      The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular~     diabetic retinopathy or is primarily caused by direct neurologic damage from chronic~     hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of~     retinopathy is intriguing and potentially links retinal neuropathy to other diabetic~     neuropathies.~      Neuroretinal degeneration initiates and/or activates several metabolic and signalling~     pathways which participates in the microangiopathic process as well as in the disruption of~     the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic~     retinopathy.~      Retinal ganglion cells are the earliest cells affected and have the highest rate of~     apoptosis. However, an elevated rate of apoptosis has been also observed in the outer~     nuclear layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of~     spectral domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers~     at higher resolution and indicates that the thinning of the inner retina in the macula is~     primarily due to loss of ganglion cells.~   "
33342|NCT02620631|"~     This is a prospective, randomized, double-blinded, placebo-controlled study designed to~     examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing~     total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve~     catheter. The protocol consists of two parts: (1) a prospective patient recruitment study~     and (2) a retrospective assay for endocannabinoids on previously collected specimens.~   "
33343|NCT02620618|"~     Intravitreal injection of up to 2 mg of infliximab has proved to be safe in animal models~     (rabbits and primates). These studies have shown no evidence of intraocular inflammation or~     toxicity by clinical, electrophysiological, and histopathological examination for up to 90~     days even with 3 repeated monthly injections. However, the study conducted by Rassi et al~     was the only one to report the development of severe intraocular inflammation in one eye out~     of 12 rabbit eyes at 90 days following 3 intravitreal injections (2mg monthly).~     Unfortunately, clinical studies conducted on patients, so far, have raised serious concern~     about its safety and adverse effects.~      These clinical studies have shown various and inconsistent results in terms of the safety~     and efficacy of intravitreal infliximab. These studies were conducted on patients with~     refractory as well as naïve cases of age related macular degenerations choroidal~     neovascularization (AMD CNV), diabetic macular edema (DME), central retinal vein occlusion~     (CRVO), angiomatous malformations, pseudophakic macular edema, and uveitis. The doses used~     ranged from 0.5mg to 2mg. The initial study by Theodossaidis et al in 2009 did not report~     any intraocular inflammation in 3 patients receiving 2 intravitreal injections of 1 and 2 mg~     for refractory AMD CNV with 7 months follow up period.(8) Later several clinical studies~     have reported severe intraocular inflammation following intravitreal injections of~     infliximab in non-uveitic patients.These collected data have initiated a call for cautious~     use of intravitreal infliximab.~      On the other hand, studies investigating intravitreal infliximab in uveitis patients have~     shown improvement in vision, reduction in macular thickness on optical coherence tomography~     (OCT), and reduction in inflammation. In this study, we have investigated the safety and~     efficacy of 3 consecutive intravitreal infliximab injections (1 mg/0.05 mL, 6 weeks apart)~     in carefully selected group of patients with refractory uveitis in Behcet's disease.~   "
33344|NCT02620605|"~     Study the effect of early cabergoline administration in prevention of occurrence or~     decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And~     its effect on oocyte maturation,fertilization and pregnancy rate..~   "
33345|NCT02620592|"~     This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.~   "
33359|NCT02620410|"~     The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral~     Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm~     the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the~     treatment of the symptoms of overactive bladder (OAB) as well as capturing patient~     satisfaction and quality of life data.~   "
33346|NCT02620579|"~     Chronic shoulder pain is a common, costly, and disabling problem for society. The~     identification of factors predictive of the development of chronic shoulder pain is~     necessary to develop innovative and effective treatments to reduce the societal impact of~     shoulder disorders. In previous work the investigators identified a genetic and~     psychological subgroup that robustly predicted heightened shoulder pain responses in a~     pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical~     cohort. In this follow-up study the investigator proposes to test how interventions tailored~     to the high risk subgroup affect pain responses in a pre-clinical cohort.~      The optimal theorized match for the identified high-risk subgroup is a combination of~     personalized pharmaceutical and education interventions. This combined personalized~     intervention versus a placebo pharmaceutical and general education intervention group is the~     primary comparison of interest. Also, an evaluation of the individual effect of personalized~     pharmaceutical and educational interventions will be part of the study. Such comparisons~     will provide important information on what the active portion of the combined personalized~     intervention may be.~   "
33347|NCT02620566|"~     To our knowledge there is still no study comparing the local wound infiltration by itself~     without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of~     this study was to evaluate anesthesia and recovery profile in pediatric patients after~     inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).~   "
33348|NCT02620553|"~     A dose with proven drug bioavailability to the immune system for use in a phase II/III~     primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk~     subjects.~      Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose~     escalation primary intervention pilot study.~      Accrual Objective 25 (3:2 randomization to active and control arms)~   "
33349|NCT02620540|"~     The purpose of this prospective single center study is to investigate if a developed~     algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are~     required to collect anonymized data (length, weight, age, anaesthesia material used during~     anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis~     ist that the algorithm has a better accuracy than the BT.~   "
33350|NCT02620527|"~     Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic~     alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA~     (ctDNA) within different solid tumor types and has been developing an assay in order to do~     so.~   "
33351|NCT02620514|"~     The purpose of this is to formally assess health literacy and medication adherence in~     participants with Inflammatory bowel disease (IBD). The study also aims to improve~     medication adherence, health-related quality of life, and disease activity through a 24-week~     intervention.~   "
33352|NCT02620501|"~     Patients will be randomized to a placebo or study group who will receive topical lidocaine~     prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction~     will then be assessed.~   "
33353|NCT02620488|"~     This pilot study will assess the effects of a brief laboratory-based guided imagery~     procedure on responses to pain in patients with sickle cell disease (SCD) and healthy~     controls.~   "
33354|NCT02620475|"~     The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing~     scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The~     scar will be evaluated using subjective clinical assessment criteria. Each participant in~     the study will serve as a control and experiential study, since have of the incision will be~     treated with the gold standard of care and the other half with SutureSafe dressings.~   "
33355|NCT02620462|"~     Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the~     elderly and can cause loss of knee joint proprioception that contributes towards~     deterioration of postural balance. Maintaining a good postural stability is essential while~     performing everyday functional activities and to avoid falls. Exercise training has been~     reported to reduce pain as well as improve performance of functional tasks in patients with~     KOA however compliance to exercise can be challenging due to pain, lack of motivation and~     traditional nature of exercise that can easily overtax patients. Furthermore, there are not~     exercise programs that are specifically designed for patients with KOA in order to address~     lost knee joint proprioception. Recent studies have also demonstrated that visual feedback~     during exercise can enhance the benefits of exercise training. Therefore, the aim of the~     proposed study is to implement an interactive sensor-based exercise training to improve~     postural balance, gait and activities of daily living in patients with KOA.~   "
33356|NCT02620449|"~     The purpose of the study is to learn more about how common food additives can affect~     phosphorus metabolism in people with normal kidney function and people with chronic kidney~     disease.~   "
33357|NCT02620436|"~     Objectives: The primary objective of this evaluation is to determine if well-constructed and~     well-resourced Maternity Waiting Homes are utilized by pregnant women living at distance~     from the health facility and are associated with improved pregnancy outcomes, particularly~     for women living farthest from health facilities. Findings from this evaluation will be~     provided to policymakers formulating policy decisions affecting the implementation of the~     Maternity Home Model and, if applicable, will be used as evidence for programmatic decisions~     made by the Ministry in deciding to take this model to scale beyond the districts proposed~     for this project.~      Primary Impact Evaluation Question: Does the Minimum Core Maternity Home Model increase~     access to high quality intrapartum care among mothers living more than 10 km from the~     facilities compared to the standard of care?~      Study Design: We propose a quasi-experimental pre-post design wherein one implementing~     partner (BU/ZCAHRD) will use a cluster-randomized matched pair design and one implementing~     partner (University of Michigan/Africare) will utilize a matched-pair, two-group comparison~     design with no randomization.~      Methods: Using mixed-methods, we will collect data from two main sources: 1) Household~     Surveys and 2) In-depth Interviews. A quantitative household survey will be conducted among~     2,400 randomly-selected households at both baseline (2015) and endline (2018) among recently~     delivered women (delivered in the last 12 months) living more than 10 km from the~     intervention and comparison facilities.~      15% of the households enrolled in the study will be randomly selected to participate in an~     In-Depth Interview (IDI). Content will include perceptions of labor and delivery practices,~     barriers to accessing care, knowledge and awareness of MSs, perceptions of the quality of~     MS, perceptions of respectful care at the facility, post-natal care, costs, and perceptions~     of MS ownership.~   "
33358|NCT02620423|"~     The purpose of this Phase 1b study is to investigate whether intravenous administration of~     REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the~     treatment of pancreatic adenocarcinoma.~   "
33360|NCT02620397|"~     This trial is designed as a prospective, multi-center, observational study of all-comers~     eligible adult subjects presenting to participating emergency departments with symptoms~     suggestive of acute coronary syndrome (ACS)~   "
33365|NCT02620332|"~     Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the~     pancreas are destroyed such that the patient is reliant on injection of insulin to~     adequately control blood glucose levels for the remainder of his/her life. The autoimmune~     process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1~     study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study~     of safety and tolerability of administration in patients with recent onset Type 1 diabetes.~     MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been~     designed to induce or restore immunological tolerance to the beta-cell and thus control or~     limit autoimmunity to protect beta-cells~   "
33366|NCT02620319|"~     The objective of this project is to determine whether biodegradable polydioxanone stents are~     efficient in the treatment of adult patients with tracheobronchial stenoses.~   "
33367|NCT02620306|"~     The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients~     with hypertensive diabetic chronic kidney disease.~   "
33368|NCT02620293|"~     This is an open label, non-comparative investigation to determine the tolerance of Eczema~     Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.~      The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance~     will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.~   "
33369|NCT02620280|"~     This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and~     nab-paclitaxel in patients with locally advanced triple negative breast cancer. compared to~     the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in~     combination with carboplatin and abraxane, while the other half will receive only~     carboplatin and abraxane.~   "
33370|NCT02620267|"~     Individuals with schizophrenia have difficulties in functioning in the community. No one~     really knows what factors determine how well patients manage in the real world. The purpose~     of this pilot study is to try a new approach to improving a potential determinant of good~     community functioning, namely how we process sounds. Specifically, we propose to examine the~     benefit of transcranial direct current stimulation (tDCS), a new tool that is being~     developed as a safe and non-invasive neurostimulation method, for improving processing of~     sounds. Transcranial direct current stimulation involves placing a wet sponge electrode on~     the head and one on the arm. Electrical current from a device powered by a 9-volt battery~     will flow from one electrode to the other. A small portion of the current will pass through~     the skull and stimulate the brain. This procedure is non-invasive and painless and it~     results in increase or decrease of spontaneous neuronal firing in the brain. Neurons are~     brain cells that send electrochemical messages to each other. Its safety and beneficial~     effect on mental functions has been demonstrated in healthy individuals and several clinical~     populations.~      The purpose of this study is to determine if transcranial direct current stimulation can~     effect how we process sounds.~   "
33371|NCT02620254|"~     The Mast Cell Connect Registry is a voluntary, observational database that will capture~     demographic, socioeconomic, and disease information directly from patients with mastocytosis~     via a secure web-based tool. No experimental intervention is involved.~   "
33372|NCT02620241|"~     The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a~     stable upright position during 20 min. This is an addendum to the previous study with record~     number clinical trials.gov NCT02124863~   "
33373|NCT02620228|"~     This clinical device investigation is conducted by performing liver biopsies using the BIP -~     Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy~     tool guidance method and test how well BIP biopsy system is able to distinguish liver~     tumours from surrounding tissue. In addition, user feedback is obtained to improve the~     usability of the investigational device. The study does not affect the traditional treatment~     procedure and only the patients in clinical need for diagnosis by liver biopsy are included~     on voluntary basis. The invasive products used in actual biopsy operation are designed so~     that their performance is essentially equal to the currently used biopsy devices, the only~     difference is the measurement capability of biopsy needle and connection to measurement~     device.~   "
33374|NCT02620215|"~     About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a~     lengthy process especially when cervical priming is required. Although mechanical method of~     induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic~     reviews comparing mechanical method against pharmacological and surgical IOL showed that~     mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric~     procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled~     trial concluded that both cervical ripening balloon and prostaglandin are effective and~     complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined~     the effects of pain.~      The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st~     prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test~     the acceptability of women in Singapore in using the CRB as an alternative method of~     induction of labour while using a non-incremental balloon filling regime. Currently, there~     is no efficient method of induction that can be used safely in an outpatient setting.~     Through this study, the investigators hope to show that there are no major adverse events in~     the 12h after patients are induced with CRB, this potentially supports outpatient IOL with~     CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling~     regime will decrease time delays and may increase patient satisfaction during its use in~     induction of labour.~   "
33375|NCT02620202|"~     The main aim of the WESTCOR study is to~        -  investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to~          diagnose acute coronary syndrome and predict prognosis in different patient populations~          (e.g. gender, age and co-morbidity)~        -  to validate the suggested 1 hour protocol for rule in and rule out of acute coronary~          syndrome for two hs-cTn assays in an unselected chest pain population~        -  to investigate different biomarkers ability to predict long term prognosis after~          hospitalization for chest pain~   "
33391|NCT02619994|"~     The purpose of this study is to compare the efficacy of a 'new treatment regimen including~     delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months~     (investigational arm)' and 'the standard treatment regimen including injectables for 20 to~     24 months (control arm)' for treating quinolone sensitive multidrug-resistant tuberculosis.~   "
33376|NCT02620189|"~     Preliminary data suggest that up-regulation of Interleukin -17 (IL-17) and the T-helper 17~     (Th17) pathway occurs in rheumatoid arthritis (RA) patients on anti-Tumour Necrosis Factor~     (TNF) therapy who demonstrated an incomplete clinical response. A deeper understanding of~     this is required in order to determine whether IL-17 or the Th17 pathway is a valid target~     for intervention in this population to improve response outcome.~      The study objective is to observe biologic naïve RA subjects on anti-TNF therapies and take~     measurements of peripheral blood and synovial tissue to assess differences in the IL-17 and~     Th17 pathways between responders and non-responders. The aim of the study is to test if~     increased Th17 pathway activity is present in subjects who do not respond clinically to~     anti-TNF therapy.~      Clinical assessments, synovial bio-markers and ultrasound will be used as determinants of~     clinical response. The study may identify disease characteristics that determine which~     subjects may be more likely to respond to anti-TNF therapy, or those who may require either~     a different treatment option, or additional pathway inhibition in addition to TNF, in order~     to achieve clinical response.~   "
33377|NCT02620176|"~     We are evaluating the role of transcutaneous electrical vagal nerve stimulation in the~     prevention of oesophageal pain hypersensitivity using a validated human model in healthy~     volunteers.~   "
33378|NCT02620163|"~     To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in~     patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment~   "
33379|NCT02620150|"~     This is a 10 week, double-blind, placebo controlled trial to evaluate SSRI (Selective~     Serotonin Reuptake Inhibitor) effects for treatment of depression in HIV/AIDS with a focus~     on innate immunity and inflammation. Depressed population is HIV + on cART, not currently on~     treatment for depression. Subjects will complete cognitive behavior therapy, CCBT for their~     depression. Blood samples collected for virologic, neuroendocrine, and immunologic~     evaluation. Our overarching hypothesis is that SSRI treatment of depression and improvement~     of depressive symptoms leads to increased innate immunity and decreased inflammation,~     resulting in better control of HIV disease and decreased morbidity.~   "
33380|NCT02620137|"~     A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was~     performed. Patients were randomized into 2 groups: those patients receiving the multivitamin~     supplement during 3 months (Group 1), and those receiving the supplement during 12 months~     (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months~     after surgery.~   "
33381|NCT02620124|"~     Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the~     outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.~      Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa~     analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and~     progesterone levels 14 days after thawing~   "
33382|NCT02620111|"~     The aim of this study is to investigate potential protein synthesis effects of whey protein~     high in leucine compared to whey protein with normal leucin content in elderly patients in a~     acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with~     15Nphenylalanine along with blood samples and muscle biopsies.~   "
33383|NCT02620098|"~     The purpose of the study was to examine the effectiveness of an occupational therapy led~     handwriting intervention for special education and at-risk kindergarten students.~   "
33384|NCT02620085|"~     Observe the relationship between thyroid function and personality traits~   "
33385|NCT02620072|"~     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta~     cells. The process of autoimmune destruction is identified by circulating islet~     autoantibodies to beta cell antigens, and is mediated by a lack of immunological~     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or~     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T~     cells. Immunological tolerance can be achieved by administration of antigen under~     appropriate conditions. Evidence is now emerging in humans that these approaches may be~     effective in chronic inflammatory diseases such as multiple sclerosis and allergy.~     Administration of oral insulin in multiple islet autoantibody-positive children offers the~     potential for inducing immunological tolerance to beta cells and thereby protect against~     further development progression to type 1 diabetes.~   "
33386|NCT02620059|"~     The aim of this study is to examine the impact of lifestyle intervention on postpartum~     weight loss. So the investigators will have two groups in this study. In Experimental group~     women will receive the Healthy Lifestyle Intervention. This intervention will have been~     delivered during 12 weeks. In Control group women will receive general information via~     pamphlet about postpartum period and tips for stress management.~   "
33387|NCT02620046|"~     The purpose of this study is to obtain long term safety and tolerability data of vedolizumab~     subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's~     disease (CD).~   "
33388|NCT02620033|"~     The researchers hope to learn if yoga complementary therapy would improve health-related~     quality of life, recovery of urinary continence and erectile function in patients who~     underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in~     patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary~     therapy would improve health- related quality of life (HRQOL), recovery of urinary~     continence and erectile function.~      This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care~     group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in~     patients who underwent radical prostatectomy (RP). Yoga therapy will be given to the~     intervention group three times in a week for 6 weeks prior to surgery and then initiated 3~     weeks after the surgery for another 6 weeks. The yoga exercise will be tailored to the~     participant's comfort level. As an exploratory analysis, we will evaluate pro-inflammatory~     and immunological markers.~   "
33389|NCT02620020|"~     The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo~     as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI)~     Numerical Rating Scale (NRS).~      Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to~     placebo as measured by:~        -  Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score~        -  Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP)~          score~        -  Change from baseline in the average daily LBPI NRS score~   "
33392|NCT02619981|"~     150 children aged between five and seven years presenting for the first dental visit, whose~     parents consented to participate in the study were selected from patients reporting to the~     dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse~     rate for each patient was measured at different clinical situation starting from patient~     parent separation until end of appointment using a pulse oximeter, Data which collected was~     statistically analyzed using appropriate statistical analyses using SPSS ver.19 data~     processing software.~   "
33393|NCT02619968|"~     The aim of this study is to analyze the effectiveness of physical exercise with blood flow~     restriction on the diameter and the flow of vessels, muscle strength and circumference of~     the forearm in patients with CKD prior to making FAV.~   "
33394|NCT02619955|"~     The study explores the hepcidin deficiency causes of rare iron overload (excluding C282Y~     homozygosity), and aim to characterize this iron overload in term of clinical, biological,~     genetic and functional spacificities.~   "
33395|NCT02619942|"~     To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could~     improve disease-free survival in patients with right colon cancer, compared with standard D2~     radical operation.~   "
33396|NCT02619929|"~     The aim of this non-interventional study is to assess oral vinorelbine dose schedules~     (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of~     treatment under routine conditions in Germany together with the underlying reasons for the~     respective chosen schedules.~   "
33397|NCT02619916|"~     The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)~     and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in~     patients after cancer~   "
33398|NCT02619903|"~     Chronic obstructive pulmonary disease (COPD) and gastric ulcer both get infected via or from~     the oropharyngeal tissues and have antibiotics in their treatment regimen of both diseases.~     This proposal suggests that the oral microbiome, in particularly dental plaque, is a~     plausible source of reinfection of COPD and gastric ulcer.~      Subjects with COPD or gastric ulcer are randomized to an adjunctive dental cleaning or no~     dental treatment. Both groups undergo the regular treatment for their respective diseases.~     Both groups have a full dental examination and have salivary microbiota as well as dental~     plaque harvested.~      The primary outcome variables is COPD exacerbations and new gastric ulcer event, and the~     secondary outcome variable re-colonization of the stomach and lung.~      Given that the study shows that additional dental cleaning does have an impact on~     reinfection of gastric ulcer and COPD it implies that dental cleaning should be subsidized~     when treating these diseases. This would have a significant impact on restricting antibiotic~     resistance as both H. pylori infections and COPD are treated with antibiotics. Both diseases~     also cause personal suffering and consequently disables the person to work, which causes~     financial consequences, and of course healthcare expenses.~   "
33399|NCT02619890|"~     This registry aims to collect clinical and radiologic information including detailed~     clinical, conventional MR and advanced MR imaging data of patients with brain gliomas.~     Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging~     (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and~     chemical exchange saturation transfer (CEST) imaging. This registry will describe course of~     disease and long-term outcomes of brain gliomas.~   "
33400|NCT02619877|"~     This is a phase II single-blinded study to evaluate the efficacy of ALLO-ASC-DFU in patients~     with Diabetic Foot Ulcer, compared to standard therapy.~   "
33401|NCT02619864|"~     The standard or usual treatment for this disease is standard chemotherapy alone. For the~     first part of this study (phase I), there are two purposes. The first is to see whether~     AZD2014 can affect glioblastoma multiforme, and the second purpose is to see what effects it~     has.~   "
33402|NCT02619851|"~     This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test~     the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn~     wound subjects.~   "
33403|NCT02619838|"~     The objective of this study is to prospectively evaluate the mid-term results and~     intraoperative and postoperative complication rate in patients who underwent double or~     triple arthrodesis using CCS screws.~   "
33404|NCT02619825|"~     First, investigators must determine the physiological standards across age classes of~     myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular~     stiffness [VD] and left ventricular [LV]). This will be done in groups of children without~     heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year~     1 year-5 years, 5 years-15years]).~      Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on~     different groups of children (same age group) with cardiomyopathy and examine correlations~     with the conventional parameters of systolic and diastolic function of both ventricles and~     with myocardial strain values. The total population of the study will be 120 children (40~     healthy, 80 patients).~   "
33405|NCT02619812|"~     To understand the mechanisms associated with diarrhea in patients receiving conditioning~     chemotherapy prior to autologous stem cell transplantation and to test the effects of the~     studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea~     associated with conditioning chemotherapy.~   "
33406|NCT02619799|"~     This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally~     administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and~     duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and~     rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine~     via epidural route.~   "
33407|NCT02619786|"~     The purpose of this study is to determine whether inhaled colistin is effective in the~     treatment of ventilator associated tracheobronchitis due to gram negative organism~     susceptible to colistin.~   "
33421|NCT02619604|"~     This project addresses the need to improve physician knowledge and clinical practice~     patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic~     leukemia (CLL).~   "
33422|NCT02619591|"~     Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques~     have been described. A single view for each hemi-thorax, and multiple views for each~     hemithorax. The investigators are comparing these two techniques in a randomized prospective~     trial.~   "
33408|NCT02619773|"~     Infections at the site of surgical incisions (SSIs) are the most common infection among~     surgical patients. Although all patients undergoing surgical procedures are at risk for~     developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging~     from 3-45%. These infections can increase the length of hospital stay, and increase the rate~     of readmissions and costs.~      Further research is needed to study the effects of mupirocin in general surgery. A recent~     study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings.~     The results of this show that mupirocin has the greatest effect on reducing SSI rate when~     compared to standard gauze dressings. However, these studies have not been performed in the~     United States and have only been studied on a very specific patient population.~      The purpose of this study is to assess the rate of infections at the surgical incision after~     colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing~     without mupirocin.~   "
33409|NCT02619760|"~     The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy~     (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium~     stent (CoCr-EES).~   "
33410|NCT02619747|"~     Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4~     hour pH monitoring following a refluxogenic meal and drink.~   "
33411|NCT02619734|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow~     stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell~     disease.~   "
33412|NCT02619721|"~     Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation~     to patients with refractory Overactive Bladder.~   "
33413|NCT02619708|"~     In the current constantly changing healthcare landscape quality measurement has a central~     role. As the practice of medicine is shifting from authority to accountability, the quality~     of surgical interventions is under continuous scrutiny by patients, peers, payers, and~     policy makers. If done appropriately quality measurement can empower all members of the~     healthcare debate. There is increasing focus on patient satisfaction outcomes as quality~     indicators.~      An important part of surgical outcomes is a patient's perception of the result of the~     intervention and overall experience in the preoperative setting. When assessing surgical~     outcomes, measuring patient satisfaction is necessary. A qualitative systematic review of~     patient satisfaction measures noted a scarcity of well-development quality improvement~     initiatives to improve patient satisfaction. Anxiety, a potent behavioral and psychological~     reaction, weighs heavily on a patient's perioperative experience and is exacerbated by~     preoperative concerns about underlying disease and impending anesthesia and surgery.~      There are multiple stressors on the day of the surgery: unfamiliar environment, multiple~     forms to be signed, and multiple short encounters with new and unfamiliar personnel. These~     create confusion, increase baseline anxiety, and can negatively affect patient experience,~     and by extension surgical outcomes.~      Increasing familiarity with this environment can help patients feel more informed about what~     matters most to them, and have more accurate expectations of possible benefits and harms of~     their options. This can potentially decrease overall anxiety, improve patient satisfaction,~     and decrease pain levels. With the current study investigators will have the following two~     specific aims:~      Aim 1. To determine whether an immersive preoperative experience (video) is associated with~     decreased anxiety and improved patient experience during the perioperative phase.~      Aim 2. To determine whether an immersive preoperative experience is associated with~     decreased stress, improved patient satisfaction, and decreased pain during the perioperative~     phase.~   "
33414|NCT02619695|"~     Mechanical low back pain is one most important emergency department presentations of~     patients seeking pain relief. Although parenteral pain killers such as opioids,~     non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients,~     application of analgesics in gel forms might be an reasonable alternative to these drugs~     with fewer adverse effects.~   "
33415|NCT02619682|"~     This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as~     treatment to help keep cancer from coming back after stem cell transplant (maintenance~     therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may~     stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide~     as maintenance therapy after transplant may prolong the length of time until the cancer~     returns.~   "
33416|NCT02619669|"~     Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable~     adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase~     referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128 or~     MLN0128) targets 2 distinct multiprotein complexes, mTORC1 and mTORC2. TAK-228 selectively~     and potently inhibits mTOR kinase (IC50 = 1.1 nM), inhibits mTORC1/2 signaling, and prevents~     cellular proliferation.~      The mTOR complex (mTORC) is an important therapeutic target that is generally stable (i.e.,~     low tendency to mutate) and is a key intracellular point of convergence for a number of~     cellular signaling pathways. Inhibiting mTOR may inhibit abnormal cell proliferation, tumor~     angiogenesis, and abnormal cellular metabolism, thus providing the rationale for mTOR~     inhibitors as potential agents in the treatment of a number of indications including solid~     tumor and hematological malignancies, as either monotherapy or in combination with other~     chemotherapeutic agents. Like rapamycin, several newly approved rapalogs (temsirolimus and~     everolimus) are specific and allosteric inhibitors of mTORC1, and only partially inhibit~     mTORC1 signaling pathways. They do not directly inhibit mTORC2, which has shown to be an~     emerging target in cancer research. TAK-228 was developed to address the incomplete~     inhibition of the mTOR pathway by rapalogs.~      Eligible subjects will have a research biopsy and baseline blood and urine studies done~     within two weeks prior to start of study treatment. Subjects will then be treated with~     TAK-228 for 10 days, and a repeat biopsy and pharmacokinetics will be done on day 11.~      The subject will then be treated with the combination of TAK-228 and letrozole for an~     additional 110 days, before undergoing resection of the primary tumor. Subjects will be~     treated at the recommended Phase II dose of TAK-228 of 3 mg once daily, and a dose~     deescalation to 2 mg daily will be performed if dose-limiting toxicity is seen in 1/3 or~     more of the subjects at the first dose level. The maximum tolerated dose cohort will be~     expanded to include six to ten subjects.~   "
33417|NCT02619656|"~     The investigators hypothesize that using carbon dioxide for PEG placement versus using room~     air will decrease post-procedure pneumoperitoneum as well as improve post-procedure~     bloating/pain, and waist circumference.~   "
33418|NCT02619643|"~     Following brain injury (e.g. stroke), application of non-invasive brain stimulation may~     improve rehabilitative efforts. However, the most effective method of non-invasive brain~     stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive~     brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic~     stimulus to the head. This method can be applied in a manner that increases (facilitates) or~     decreases (depresses) excitability within the brain. Furthermore, applying two consecutive~     PAS sessions within minutes of each other (called primed PAS) may augment changes in~     excitability more than a single PAS session alone.~      Thus, the purpose of this study is to compare the effect of a double PAS session (primed~     PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy~     individuals.~   "
33419|NCT02619630|"~     The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and~     maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.~   "
33420|NCT02619617|"~     The purpose of this study to determine if SOM230 is safe and effective for the treament of~     cluster headache.~   "
33423|NCT02619578|"~     During the past four decades, gynecologic laparoscopy has evolved from a limited method to~     an advanced operative approach that frequently serves as a substitute for laparotomy. The~     advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital~     stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and~     intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic~     activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia,~     which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing~     the concentration of plasma catecholamines, cortisol and vasopressin , these responses have~     an important impact on patient recovery after surgery.~      Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous~     electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on~     acupuncture, has been widely accepted and used worldwide. To date, multiple studies have~     demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the~     incidence of postoperative nausea and vomiting (PONV) and improve postoperative cognitive~     function. However, whether TEAS could improve the quality of early recovery after~     gynecologic laparoscopy is unknown. In this study we therefore investigated the effects of~     TEAS at the acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6)~     on the quality of early recovery in the patients undergoing gynecological laparoscopic~     surgery.~   "
33424|NCT02619565|"~     This study aims at prospectively enrolling a cohort of 400 incident cases of myelodysplastic~     syndromes (MDS) at diagnosis, to evaluate the impact of recurrent mutations on overall~     survival and event-free survival, using next generation sequencing. Patients are affected by~     ineffective hematopoiesis and a propensity to leukemia in the elderly with a global~     incidence of 10/100,000/year.~   "
33425|NCT02619552|"~     Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal~     pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective~     medical treatments exist to treat the disease; however they can have significant side~     effects.~      Previous studies have shown that sexual function is impaired in patients with Crohn's~     disease. It is likely that both the symptoms related to the disease, medications used to~     treat the disease, and surgery all impair sexual function in a variety of ways. For example,~     body image may be impaired, patients may be worried about bowel incontinence or unpleasant~     odors associated with diarrhea, patients may have significant pelvic pain secondary to~     perianal fistulas, or they may have painful intercourse from adjacent inflammation or~     scarring in the pelvis. The impact of medical treatment on patient's ability to regain~     sexual function is not known.~      The investigators propose a 6 month study to compare sexual function before and after~     treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug~     for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with~     steroids.~      The investigators anticipate that the investigators will show that therapy with an anti TNF~     agent will result in a more rapid and greater return of sexual function than steroids. This~     information will be important to help counsel patients about the optimal treatment to begin~     for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate~     the impact of medical therapy on sexual function.~   "
33426|NCT02619539|"~     Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without~     the need to perform other potentially time consuming investigations.~   "
33427|NCT02619526|"~     Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical~     trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves~     the outcomes of patients with HF. However, limited data have been available on the treatment~     of HF with preserved ejection fraction (EF) in the elderly. No study has specifically~     compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age~     patients with preserved EF.~   "
33428|NCT02619513|"~     The purpose of this study is to explore the effectiveness of dexmedetomidine as an~     adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for~     Post-thoracotomy Pain Syndrome(PTPS).~   "
33429|NCT02619500|"~     The purpose of this clinical trial is to compare the use of thrust manipulation to~     non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical~     and thoracic spine. Both of these techniques have been compared in previous trials but a~     pragmatic approach will be employed as well as controlling for clinical equipoise.~   "
33430|NCT02619487|"~     The purpose of this study is to determine whether a simple text message reminder sent to the~     parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in~     helping the individual(or parent) become more compliant with self-managing the Type 1~     Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12~     years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with~     T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with~     T1D,no text message sent to parents of children age 8-12 years, and no text message sent to~     adolescents or parents of adolescents age 13-18 years old.~   "
33431|NCT02619474|"~     These days, particularly over the last decade, attention is being paid to the opinion of the~     patient and, in the case of pediatrics, the patient's family. Unfortunately, recent work has~     shown that this remains an imperfect process. Studies of inpatient families show that~     parents often leave hospital with only a minimal idea of side effects of drugs, who they can~     contact in the event that something goes wrong, and even something as simple as the date of~     the next medical visit. In fact, some studies have shown that adult patients don't even know~     the name of their doctor or nurse.~      While there are several papers examining the degree of unhappiness of parents in hospitals,~     there is very little research looking at what can be done to improve a patient's sense of~     satisfaction with care (and communication) while in the hospital. One suggestion has been~     the provision of whiteboards in the room that can allow the family to have a better idea of~     what is going on during the child's day. These have been suggested but never exposed to~     prospective, quantitative study.~      With the intention of improving the management of patients in the new Acute Care Centre, the~     department of strategic planning at Children's Hospital organized a three day IMPROVE~     session moderated by PHSA specialists in quality control. During this meeting, the clinical~     course of a child on the medical and surgical wards was mapped out. This allowed the group~     to examine various ideas aimed at improving the care of children passing through the~     hospital and the sense of parental satisfaction with the whole process.~      The main conclusion from the meeting (based both on available literature and the clinical~     experience of the group), was that communication between the medical team and parents should~     be improved. It was also concluded that the best way to do this would be to have a regularly~     updated whiteboard in each room. Prior to starting this, it was generally felt that the~     introduction of whiteboards should be tested in a prospective controlled manner - starting~     with a baseline study of patient satisfaction.~   "
33432|NCT02619461|"~     This study describes the effect of acute high intensity exercise at 70% VO2peak on~     inflammation, stress, appetite hormones and appetite in lean and obese children and~     adolescents.~   "
33433|NCT02619448|"~     The standard treatment for patients with NSCLC (non-small cell lung cancer) and clinically~     negative lymph nodes remains surgery per current guidelines. Five year survival for patients~     with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of~     these patients have heart and lung issues or other diseases which keep them from undergoing~     curative surgery. Studies have shown that majority of these patients die from their cancer~     and not from their other diseases. This is the reason for treating early stage lung cancer~     patients with definitive therapy, when they cannot have surgery. This study will enroll~     twelve subjects to evaluate the side effects of this treatment, and decide if it is a good~     option for the patients that cannot have surgery.~   "
33434|NCT02619435|"~     The purpose of this study is to purpose of this study is to assess if regorafenib is active~     enough, in terms of 6-month progression-free rate, to warrant further comparative studies in~     patients with RAS-mutant advanced colorectal cancer who have progressed after first-line~     oxaliplatin-based chemotherapy plus bevacizumab.~   "
33435|NCT02619422|"~     To determine if an intensive cardiac rehabilitation program with periodic reinforcements~     improve the compliance/adherence to secondary preventive measures (physical exercise,~     mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary~     syndrome with or without ST segment elevation versus an standard cardiac rehabilitation~     program~   "
33436|NCT02619409|"~     Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic~     procedures. In some cases the duration of the block is inadequate. An epinephrine wash is~     sometimes performed to prolong the duration of the block. The epinephrine wash may prolong~     the duration of the block, and if it does, to what extent?~   "
33437|NCT02619396|"~     Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid~     electrical activity originating from the pulmonary veins (PVs) that drain blood from the~     lungs back to the left atrium (LA). Ablation of the junction between the PVs and the LA,~     electrically isolating the veins from the heart, is the key to prevent AF.~      When using radiofrequency energy (RF), transmural lesions are required to achieve permanent~     pulmonary vein isolation (PVI). New technologies are currently available to predict the~     ablation lesion depth and to guide the duration of each application. However, deeper lesions~     mean a higher risk of overheating and damage of adjacent structures such as the esophagus~     that lies against the back wall of the LA. In order to minimize this risk, the investigators~     continuously monitor the temperature inside the esophagus during the procedure through a~     probe placed in the esophagus and they promptly terminate energy delivery in case of any~     esophageal temperature rises more than 39°C.~      To date, it is not known if a low power for a longer time is better than a high power for a~     shorter time when ablating on the LA posterior wall in order to create permanent scars~     without heating the esophagus.~      Therefore, the investigators plan to compare the incidence of esophageal temperature alerts~     and the success of the procedure with four different energy settings during ablation on the~     LA posterior wall.~   "
33438|NCT02619383|"~     Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and~     improve impaired organ function. HBOT was also recently suggested as a possible therapy for~     ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not~     been investigated to date.~      The objective in this study was to assess the effect of HBOT on patients with ED by means of~     sexual function questionnaires and novel imaging techniques.~   "
33439|NCT02619370|"~     The overarching goal of this project is to facilitate engagement of individuals in effective~     advance care planning (ACP). Our specific objective is to conduct a randomized, controlled~     trial to determine whether playing a structured conversation game will increase the~     likelihood that participants will complete advance directives and perform other ACP~     behaviors compared to those who are provided with only standard ACP educational materials.~   "
33440|NCT02619357|"~     The prevalence, low cost, and low burden of wearable devices that provide quantitative and~     qualitative feedback on a subject's activity level present an opportunity for the use of~     these devices in clinical and observational studies. However, the accuracy and~     reproducibility of any given device may vary with device design and algorithm~     implementation. Therefore, validation of emerging technologies against known standards such~     as analysis of exhaled breath and currently available medical devices is critical. This is a~     single center, two-cohort, single period, open-label, methodology study. No investigational~     product will be used in this study. Eligible subjects will wear 2 generations of SenseWear~     Armband devices, 2 ActiGraph GT9x devices (one on the wrist and one on the waist) and a~     Garmin Vivofit 2 activity tracker wristband for up to 24 hours per day. Subjects who consent~     to participate in an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while~     sleeping. Subjects will perform a variety of laboratory and field-based exercise tests and~     strength exercises using Latex-Free Therabands.The co-primary objectives of this study are~     firstly to compare the outputs of the test devices (SenseWear Armband Gecko and Actigraph~     GT9x) to those of the SenseWear Armband MF and secondly to assess the sensitivity and~     accuracy of the test devices in subjects with COPD or asthma while performing~     laboratory-based exercise testing.~   "
33441|NCT02619344|"~     The overall hypotheses of this project is that severe sepsis is associated with endothelial~     dysfunction in pediatric patients and that selenium deficiency is associated with changes in~     biological markers of endothelial dysfunction and that these changes, in turn, are~     associated with worse clinical prognosis.~   "
33442|NCT02619331|"~     Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin~     reactivity to allergens. Multiple factors can contribute to non-optimal results of~     conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements,~     observer-dependency and absence of traceability.~      This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler~     Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen~     extracts as well as positive and negative controls will be performed in 20 volunteers (11~     atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and~     allergen concentration) of HSL-DI analysis based on two parameters (area and flow~     measurement). In a second step, fifty patients will be tested with birch and grass pollen~     extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and~     CWFM will be compared.~   "
33443|NCT02619318|"~     This is a RCT study, aiming at evaluating the effectiveness of the Everyday Life in Balance~     (BEL) intervention.~      The intervention: The BEL was developed on the basis of previous research on lifestyle~     interventions made by the current research group and other researchers . It is a group-based~     programme (5-8 participants) with 12 sessions, one session a week, and 2 booster sessions~     with two-week intervals. The themes for the group sessions are, e.g., activity balance,~     healthy living, work-related activities, and social activities. Each session contains a main~     group activity and a home assignment to be completed between sessions. The main group~     activity starts with analysing the present situation and proceeds with identifying desired~     goals and finding strategies for how to reach them. The home assignment is aimed at testing~     one of the proposed strategies. Self-analysis, setting goals, finding strategies and~     evaluating the outcome of tested strategies form a process for each session, but also for~     the BEL intervention as a whole. After completed BEL, the participants will have developed~     an ability to reflect on their own situation and have strategies for changing their everyday~     life in a desired direction, such that they feel their everyday life has a satisfactory~     balance between rest and work, secluded and social activities, etc.~      The BEL intervention is led by occupational therapists. They take part in a specifically~     developed two-day education and follow the BEL manual [7]. They also participate in a~     web-based discussion forum where they can seek support from the researchers and/ or other~     BEL occupational therapists.~      Selection of units and participants: On the basis of blocks of four units, two are~     randomized to the BEL and two to the control condition, which is care as usual (CAU) and~     generally means standard occupational therapy. Occupational therapists in the units select~     participants based on the patients' needs for a lifestyle intervention and being likely to~     benefit from a group intervention. The same criteria are applied in the BEL units and the~     CAU units.~      Power analysis: The investigators desire 120 participants from each group. This will also~     allow for analysis of subgroups.~      Instruments: A number of self-report instruments tapping satisfaction with daily~     occupations, well-being, perceived worker role, social interaction, recovery etc., will be~     used, supplemented with qualitative interviews.~      Procedure: As the intervention starts, the attendees answer questionnaires about their~     personal situation regarding. Subsequently, the BEL is implemented in the units randomised~     to that condition. After 16 weeks of intervention (including the booster sessions), the~     measurements are repeated. A follow-up is then made after another six months. The same data~     collection is made at corresponding time points in the comparison units.~      Additional qualitative interviews are made in the intervention units, with strategically~     selected participants (attendees and staff) to get a deeper picture of the intervention~     process and its implications.~      When the research project is finished, the comparison units will be given the opportunity to~     go through the intervention.~      Analyses: The primary analysis concerns differences in outcomes between the BEL group and~     the CAU group. Analyses of the qualitative interviews, by means of grounded theory, will~     yield a more detailed description of the BEL and its implications, as perceived by both~     attendees and staff.~      Current state of the study: The project is in the initial phase and the first units were~     recruited in late 2012. At present, 24 units have been randomized to either condition. The~     second measurements (after completed BEL) have just been completed and follow-ups will~     continue until mid-2016, as will qualitative interviews. Analysing data and reporting~     results will continue until late 2018.~      By including 60 participants in each group the studies will be able to detect a medium~     effect size (ES=0.4), which would be a difference of clinical and practical significance.~      Age, gender and being of foreign origin will be considered as covariates, along with other~     socioeconomic factors such as family situation, educational level and money at one's~     disposal. Other factors that should be considered are the participant's functional status~     and diagnoses. Research has not shown that diagnosis per se plays any substantial role in~     the outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for~     how people perceive their everyday occupations, but this should be investigated further~     because the evidence is inconclusive. Level of functioning, level of psychopathology, and~     negative symptoms have indeed been shown to be of importance for outcomes of psychiatric~     rehabilitation. Therefore, this project will also control for factors related to diagnosis~     and functional status.~   "
33448|NCT02619253|"~     Primary objective: To assess the safety and tolerability of pembrolizumab in combination~     with vorinostat in patients with advanced renal or urothelial cell carcinoma in order to~     select the recommended Phase 2 dose (RP2D).~      Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in~     combination with vorinostat; (2) To assess the anti-tumor activity (i.e. objective response~     rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients~     with advanced renal or urothelial cell carcinoma; (3) To characterize PD-L1/2, immune cell~     subsets, and miRs in tumor and/or blood.~   "
33449|NCT02619240|"~     This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen~     for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of~     tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the~     investigation procedures, will be recruited for this study over a period of 18 months.~     Clinical likelihood of TB will be systematically scored according to various clinical~     parameters. This will determine the pre-test probability. Clinician will decide if anti-TB~     treatment is to be started and patients will be followed up for a minimal of 18 months.~     Sensitivity, specificity, positive, negative predictive values and the respective likelihood~     ratio will be calculated accordingly.~   "
33450|NCT02619227|"~     The objective of the study is to determine whether a livelihood intervention can improve~     economic and psychosocial wellbeing in rural Uganda.~   "
33451|NCT02619214|"~     Clinical trial controlled randomized of parallels groups. The study is designed to look for~     differences in the oxidative stress level among healthy patients receiving 2 different~     oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been~     informed, the affirmative agreement has been obtained and inclusion and exclusion criteria~     verified the patients are randomized to 30% or 60% oxygen concentration. In the operating~     room while placing the intravenous line, a sample blood is obtained. General anesthesia is~     induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine~     is fixed in order to provide the oxygen concentration according to the randomization. One~     hour later a second venous sample is obtained. Samples are stored in cold conditions until~     their analysis in the laboratories of the biology faculty - Barcelona University.~   "
33452|NCT02619201|"~     Acute gastroenteritis (GEA) is a public health problem at present, the main cause of~     vomiting and consultation in emergencies in children under 5 years. Worldwide, there are~     about 2 million deaths per year due to gastroenteritis in children under 5 years.~      In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls,~     in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic~     activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for~     girls.~      NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection~     and characterized by a sudden onset of diarrhea with or without vomiting~   "
33453|NCT02619188|"~     This study evaluate the rate of nausea and nutritional status in patients with hyperemesis~     gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a~     questionnaire (PUQE-score), self-reported food/drink intake form and blood test. The~     Investigators aim for developing normal range of prealbumin measurements (reference values)~     during first trimester of pregnancy.~   "
33454|NCT02619175|"~     aims:~        1. To characterize compensatory balance reactions to platform translations during standing~          and walking in poststroke individuals in comparison to healthy individuals.~        2. To explore the effect of lesion characteristics (location, size) on the patients'~          balance reactions.~        3. To explore the impact of clinical measures of unilateral sensory motor impairments,~          balance, gait and fear of falling on postural reactions in stroke subjects.~        4. To examine the effect of a perturbation-based balance training on balance reaction~          characteristics in post stroke individuals.~   "
33455|NCT02619162|"~     Open, multicenter phase I with gradual increase in dosage to evaluate the safety and~     tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for~     patients with breast cancer. Nintedanib is administered twice a day orally for 28~     consecutive days (Days 1-28) in 4-week cycles.~   "
33456|NCT02619149|"~     The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy~     for acute cholecystitis is insufficiently known. The aim of the present double-blind~     randomized controlled is to compare piperacilin with placebo in patients undergoing~     cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100~     patients are intended to be included. Primary endpoint is biliary contamination. Secondary~     endpoints are postoperative hospital stay, health-related quality of life, pain perception,~     postoperative markers of inflammatory response, surgical site infections, infectious~     complications other than surgical site infections, health economy and relationship between~     symptom anamnesis and bile contamination.~   "
33457|NCT02619136|"~     MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used~     transfusion strategies in patients with myocardial infarction.~   "
33458|NCT02619123|"~     The Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised~     trial aimed at evaluating the impact of tailored screening strategies addressed to~     premenopausal women, by using breast density as indicator of risk.~      44-45 years old women will be enrolled and invited to undergo a digital mammography. Women~     are then randomly allocated in two arms. In the intervention arm, women will receive a~     tailored screening strategy according to breast density.~      The aim of this study is to assess the impact of a longer screening interval and the~     reduction of side effects for premenopausal women.~   "
33459|NCT02619110|"~     The purpose of this research was to discuss the effect of backward walking treadmill~     training on balance ability, speed of walking and cardiopulmonary fitness in patients with~     chronic stroke.~   "
33460|NCT02619097|"~     The primary objectives of the trial are to assess the safety and pharmacokinetics profile of~     pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.~   "
33472|NCT02618941|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE®~     PD01A vaccinations in patients with Parkinson's disease. Patients, who have already~     participated in the AFF008 program will be involved and will receive a second boost~     immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.~      In addition, up to 6 patients will be offered participation within an untreated control~     Group.~   "
33461|NCT02619084|"~     The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep~     brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory~     Tourette's syndrome (TS).~      Secondary objectives are to individuate and standardize the best electrical parameters for~     STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as~     behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to~     correlate the improvement of TS motor and non-motor symptoms to the modification in brain~     activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the~     safety of STN DBS in TS patients.~   "
33462|NCT02619071|"~     Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with~     poor prognosis, especially after relapse. High-throughput genomic studies have highlighted~     the importance of molecular alteration in the pathophysiology, clinical evolution and~     treatment response of AML. In addition, identification of specific gene mutation can be~     targeted by specific inhibitors, opening the way to personalized treatments. However, only a~     limited number of gene mutations are druggable or actionable, highlighting the need for~     additional information to guide treatment choices. Among them, new Drug Screening Tests~     (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML~     cells. Combination of genomic and pharmacologic approaches might therefore improve~     prediction of drug effects. There is an urgent need to bring these approaches into the~     clinic but feasibility trials are necessary before incorporating them into treatments~     strategies.The proposed study is a prospective multicentre feasibility study of a combined~     chemo-genomic approach in patients with advanced AML.~   "
33463|NCT02619058|"~     Considerable progress in the treatment of metastatic melanoma has been made in the past~     5years, with the approval of immune checkpoint-blocking antibodies and agents targeting BRAF~     mutation. Investigators conducted a open label, dose escalation, phase I clinical trial of~     to explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous~     administration of autologous NKT Cells in metastatic melanoma patients.~   "
33464|NCT02619045|"~     This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of~     Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis~     of this Follow-up Program Device.~   "
33465|NCT02619032|"~     This study was a prospective comparative study. The purpose of this study was to investigate~     the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and~     stress response to the day-case dental surgery in Persons with special needs (PSN).~     Secondary aims were to investigate comparatively their effect on patients intraoperative~     hemodynamic response and postoperative analgesia.~   "
33466|NCT02619019|"~     Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it~     extended the duration of analgesia. We aim to study the effectiveness of spinal~     dexamethasone in Transuretheral prostatectomy.~   "
33467|NCT02619006|"~     When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the~     fetal-placental blood volume is left behind in the placenta. Preliminary results from our~     current study comparing effects of ICC versus placental transfusion from delayed cord~     clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age~     and more myelin in important regions of the brain. Our objective for this follow-up study is~     to see if the effects of placental transfusion persist to three and four years of age. The~     investigators plan to enroll only children who participated in the previous trial (Infant~     Brain Study/NCT01620008) at birth for assessments at three and four years of age.~     Assessments include MRIs and neurodevelopmental testing to examine cognitive, motor, visual,~     and behavioral outcomes.~      The proposed research addresses two central questions regarding the potential benefits of~     DCC on brain myelin development in children who were born healthy at term: 1. Does DCC~     result in increased brain myelin deposition at three and four years of age? and 2) Are DCC,~     iron stores, and brain myelin content in infancy associated with improved cognitive, motor,~     and socio-behavioral outcomes at three and four years of age?~   "
33468|NCT02618993|"~     The sensory innervation of the face depends on the trigeminal (fifth cranial) which is~     divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal~     and masseter muscle. The regional anesthesia of the face has grown in recent years for~     performing certain actions under light general anesthesia or sedation. The mandibular block~     is a simple and reliable technique but little used. Yet it reduces postoperative pain~     sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the~     oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it~     also improves the visibility of the operative field during mandibular osteotomies reducing~     bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of~     action of the local anesthetic), the V3 block ropivacaine is not evaluated in the~     maxillofacial surgery.~   "
33469|NCT02618980|"~     The primary aim of this study is to compare efficacy of early endoscopy and~     non-endoscopic treatment for management of acute upper gastrointestinal (UGI) bleeding in~     patients with recent acute coronary syndrome (ACS). This study will also compare rates of~     surgery, repeated intervention (endoscopy or TAE), rebleeding and complications between two~     groups.~   "
33470|NCT02618967|"~     The purpose of this study is to obtain initial information on the safety and tolerability~     (effects good or bad), pharmacokinetics (what the body does to the drug), and~     pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.~   "
33471|NCT02618954|"~     The objective of this study is to determine the longitudinal relation between clinical~     remission and ultrasound (US) remission in Rheumatoid arthritis (RA).~      At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals~     and power Doppler signals) is frequent in patients with RA in clinical remission. Several~     longitudinal studies reveal an association of US-detected residual synovitis and risk of~     relapse and radiographic progression, in individual patients and joints, over 1-2 years.~      However, the longitudinal relation between clinical remission and US remission is not so~     well-known and it is possible that clinical remission arrive before ultrasound remission.~     Thus arise the question as to whether the presence of US-detected residual synovitis require~     to adapt the treatment to ultrasound findings or to simply increase the patient care.~      The investigator propose to conduct a prospective, bi-center, non randomized study.~   "
33475|NCT02618902|"~     A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination~     with tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP)~     will be conducted. In doing so, the feasibility and safety of administering myelin-derived~     peptide-pulsed tolDC in patients with MS will be assessed.~   "
33476|NCT02618889|"~     The purpose of this research study is to evaluate if patients with psychogenic dystonia~     treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and~     disability at one month and at three months than those having received placebo injections~   "
33477|NCT02618876|"~     Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in~     children undergoing inguinal hernia repair.~      2 groups, 30 patients each~   "
33478|NCT02618863|"~     the investigators have observed that women may require less CF than men to occlude the~     esophageal entrance, and that the routine use of 30 N in women may actually increase the~     incidence of airway-related problems. The objective of the current investigation was to test~     this hypothesis. In this study, real-time visual and dynamic means were used to assess the~     effectiveness of different forces applied to the cricoid cartilage in occluding the~     esophageal entrance in men and women. The patency of the esophageal entrance was directly~     visualized using the Glidescope Video Laryngoscope in anesthetized and paralyzed patients~     with and without CP. Evidence of closure of the esophageal lumen was confirmed by the~     inability to introduce a gastric tube (GT) into the esophagus under direct vision. New~     method , using Cricometer , was used to measure the applied force .~   "
33479|NCT02618850|"~     The purpose of this study is to test whether an early metabolic response, measured by PET/CT~     scan after the first cycle of chemotherapy, is able to predict which patients with advanced~     CRC have a better prognosis.~   "
33480|NCT02618837|"~     To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based~     on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a~     population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication.~      Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard~     therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who~     undergo PCI and will thus receive these potent antiplatelet agents which may theoretically~     favor the occurrence of bleedings.~      A combined measure of efficacy and safety endpoints, the so-called net clinical benefit~     (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.~   "
33481|NCT02618824|"~     Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in~     adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by~     administration of TWBC will provide cardioprotective effect similar to adult patients.~     Histidine-tryptophan-ketoglutarate (HTK), is attractive for cardiac surgeons because it is~     administered as a single dose and is claimed to offer myocardial protection for a period of~     up to 180 minutes allowing performance of complex procedures without interruption. Merging~     the use of TWBC on the use of HTK cardioplegia, especially for pediatric cardiac cases, have~     not been investigated. This technique is expected to provide a longer ischemic time and a~     protective effect against reperfusion injury.~   "
33482|NCT02618811|"~     So far, the impact of sarcopenia has been analysed only in patients undergoing traditional~     surgical procedures (laparotomy) or those with metastatic spread. As the ERAS protocol~     combined with minimally invasive access decreases postoperative metabolic disorders, it~     seems possible that it can limit the deleterious impact of sarcopenia as well. The aim of~     this study was to investigate whether the use of ERAS protocol in colorectal cancer patients~     influences the postoperative risk due to sarcopenia.~   "
33483|NCT02618798|"~     Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic~     liver disease (CLD). The potential role of platelets and platelet activation in this process~     is unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators~     which may advance hepatic fibrosis. Hepatitis B virus transgenic mice, developed~     significantly smaller necroinflammatory foci and their serum ALT levels were 80% lower, if~     they were pre-treated with anti-platelet antibodies. Sinusoidal aggregation of activated~     platelets also occurs in chronic hepatitis C in humans. It may contribute to~     thrombocytopenia observed in CLD. Platelet activation is generally believed to be~     compromised in CLD. However, there is data suggesting that CLD may even be associated with~     an enhancement of platelet activation. Measurement of hepatic venous pressure gradient~     (HVPG) constitutes the most common method for estimation of portal venous pressure. HVPG is~     significantly correlated with histological indices of CLD progression.~      Study hypotheses:~        1. HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is~          associated with an increase in platelet activation.~        2. Platelet activation and function is not generally compromised in CLD. Comparison of~          platelet function in CLD to a control group of healthy volunteers is intended to~          clarify whether CLD leads to a manifest platelet dysfunction~      Methods: Study design is observational. 100 patients with CLD of various origins (viral,~     alcoholic, cholestatic) scheduled for routine HVPG measurement will be enrolled. 30 healthy~     volunteers will donate blood as a control group. Platelet function and activation will be~     evaluated by multiple electrode aggregometry (primary outcome variable area under the curve~     (AUC). Plasma levels of P-selectin (ELISA), PFA (Platelet Function Analyzer) 100™ parameters~     (EPI-CT and ADP-CT), percentage of P-selectin, GPIIb/IIIa, thrombin receptor positive~     platelets after stimulation (flow-cytometry) will constitute secondary outcome parameters.~     Plasmatic coagulation will be evaluated by rotational thrombelastometry (ROTEM). Platelet~     count and routine coagulation parameters will be monitored. HVPG measurement by hepatic vein~     catheterization and patient blood sampling will be carried out via the internal jugular~     vein. Blood sampling in volunteers will be performed via the antecubital vein~      Study Rationale: If higher levels of platelet activation are associated with increased~     HVPGs, this would provide an insight into the pathogenesis of CLD. It would also point~     toward a possible benefit of anti-platelet therapy in CLD. Verification of platelet~     dysfunction in CLD is relevant to clinical practice in anaesthesiology and intensive care as~     procedures are often postponed in CLD-patients for fear of bleeding complications. CLD~     patients may also receive prophylactic platelet concentrates prior to interventions which is~     costly, fraught with risk of bacterial infection and may be unnecessary in the absence of~     platelet dysfunction.~   "
33484|NCT02618785|"~     This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a~     potential effect for diagnosis of proximal tubal obstruction in infertile women. The~     investigators did a double-blind, randomized placebo-controlled trial~   "
33485|NCT02618772|"~     Laceration repair can cause significant anxiety in children. As open wounds account for~     21-25% of injuries in children presenting to the emergency department, the management of~     anxiety is of great importance. Anxiety can often lead to poor patient cooperation and the~     use of potentially excessive physical restraint. High rates of procedural anxiety have also~     been correlated with increased rates of negative behaviours after discharge.~      The current standard of care for suture closure of lacerations throughout most of Canada is~     to provide local analgesia only. The literature has therefore focused on finding anxiolytic~     adjuncts to local analgesia.~      Midazolam is an ideal adjunct due to its fast onset and short duration of action with an~     excellent safety profile. The advantages of the IN route are less pain on administration~     when compared to the IV and IM routes, and increased acceptability compared to the rectal~     route in older children. Oral midazolam also has poor palatability.~      While the onset of INM at 5-10 minutes, and duration of 20-40 minutes make it an ideal~     candidate for anxiolysis in the ED its use has been limited by the common side effect of~     nasal irritation, burning and lacrimation when it is administered in its droplet form. The~     recent development of mucosal atomization devices (MAD) has resolved this issue by~     delivering 30-μ particles to the nasal mucosa.~      Previous studies investigating the use of INM for laceration repair in the pediatric ED have~     demonstrated that INM is safe but most used non-validated measurement tools to assess~     anxiety and facilitation. Only one of these studies used atomized INM, retrospectively~     examining safety as the primary outcome. The authors reported an excellent safety profile~     for INM using the mucosal atomization device MAD-300 (Wolfe Tory Medical Inc.). The use of~     atomized INM for anxiolysis during pediatric laceration repair has not been evaluated~     prospectively.~      Most studies have focused on preschool aged children (<6 years). While studies have~     demonstrated that the prevalence of procedural anxiety is higher in younger children, up to~     51% of children age 7-12 years experience high levels of procedural distress. The~     effectiveness of INM in the pre-adolescent age group is, therefore, yet to be determined.~      It is hypothesized that INM will reduce anxiety in children age 2-12 years undergoing~     laceration repair and will facilitate the successful completion of suturing by the~     physician.~   "
33486|NCT02618759|"~     The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS~     compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.~   "
33499|NCT02618590|"~     This is a multi-center retrospective study, designing to access the best treatment strategy~     in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second~     line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is~     defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2).~     PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist~     1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter~     what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.~   "
33501|NCT02618564|"~     The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate~     magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different~     doses and administration times. The primary outcome is number of bowel motions produced.~     Secondary outcomes include the quality of bowel cleansing and patient tolerability.~   "
33487|NCT02618746|"~     COPD is the fourth leading cause of death in the world and is the only one of the top five~     illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a~     higher prevalence and death rate for COPD than many other countries in Europe. The disease~     is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite~     maximal medication and strategies such as pulmonary rehabilitation and home nurse support,~     many patients remain vulnerable, socially isolated and report difficulty in accessing their~     local health services. Research has shown that patients have worsening symptoms for an~     average of three to four days before they are admitted to hospital with an exacerbation of~     COPD. This suggests a window of opportunity to intervene. Early warning and contact via~     innovative technology may treat symptoms earlier, improve patient confidence / quality of~     life and simultaneously reduce health care visits or admissions. However, there is a large~     gap between the postulated and empirically demonstrated benefits of electronic Health~     Technologies. In addition, there is a lack of robust research on the risks of implementing~     these technologies and their cost-effectiveness has yet to be demonstrated, despite being~     frequently promoted by policymakers as if this was a given issue. In addition, the~     evidence-base for telehealth is not well-reported in peer reviewed journals and hence there~     continue to be difficulties experienced in convincing clinicians, hospital managers and~     stakeholders that investment in such technologies will enable reductions in other aspects of~     healthcare delivery over time.~      This project attempts to provide robust justification of the effectiveness of~     telerehabilitation by the implementation of a randomized controlled trial blindly assigning~     COPD patients to: i) a home care and telerehabilitation group remotely monitored by a~     specialised private health care centre (Filoktitis - group A) or ii) a hospital-based~     rehabilitation group managed at a regular base through weekly visits by personnel at a state~     University rehabilitation centre (group B). iii) A third group that receives usual care~     (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is~     also included.~   "
33488|NCT02618733|"~     Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient~     outcomes, a Phase III pivotal efficacy and safety study with a duration of up to 12 months~     comparing ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in~     acute coronary syndrome patients on ASA background, have demonstrated superiority of~     ticagrelor over clopidogrel in the prevention of fatal and non-fatal cardiovascular events.~     Currently, the mechanism for this mortality reduction remain uncertain. One hypothesis is a~     adenosine mediated theory that ticagrelor has been shown to enhance adenosine-induced~     vasodilation. Several experimental and clinical studies support the hypothesis that~     adenosine could reduce cardiac ischaemia reperfusion damage. Moreover, recent study has~     demonstrated that ticagrelor enhances adenosine-induced coronary vasodilatory responses in~     healthy humans. However, there are no available data on coronary circulation effects after~     chronic treatment of ticagrelor in patients with ACS who have altered resting coronary blood~     flow dynamics due to advanced coronary artery disease.~   "
33489|NCT02618720|"~     To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day~     before surgery) and intravenous cephalosporin (before surgical incision) with that of~     intravenous cephalosporin alone (standard of care) in combination with oral placebo on the~     incidence of SSI within 30 days after elective colorectal surgery.~   "
33490|NCT02618707|"~     Many variables measured in critically ill patients have been used to estimate severity of~     disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally~     indicate specific treatment and monitor the adequacy of treatment and its timing. It is~     unlikely that one measurement can replace all of these, but in the remainder of this~     manuscript the investigators will show that lactate levels may come close. Although in our~     mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes~     not related to tissue hypoxia and, therefore, subject to many disturbances found in various~     clinical situations~   "
33491|NCT02618694|"~     This randomized comparative study assesses the safety and efficacy of the posterior~     retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal~     approach and suppose that this new technique is a safe and effective alternative to the~     standard approach.~   "
33492|NCT02618681|"~     To investigate the feasibility of the earlobe crease as an early prognostic predictor for~     acute myocardial infarction(AMI) in Chinese population.~   "
33493|NCT02618668|"~     The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic~     stability, recovery time ,patient & doctor satisfaction scores during Endoscopic Retrograde~     Cholangiopancreatography.~   "
33494|NCT02618655|"~     The study will use several laboratory diagnoses in the diagnosis of patients with fever，to~     find out which will be more helpful for making an accurate diagnosis in the early period of~     Tickborne Diseases.~   "
33495|NCT02618642|"~     Plotting i/t curve before a series of phototherapy treatments and after their completion.~     Pain threshold assessment with algometer. i/t curve. Creation of 3 test groups: 1 - Piler~     light + red filter, 2 - Piler light + blue filter, 3 - Piler light without a filter.~     Creation of a numerical coefficient for i/t curve.~   "
33496|NCT02618629|"~     The aim of this Phase I study is to determine the absorption, metabolism, and excretion of~     14C-Z-215 in healthy male subjects following a single oral administration at a~     therapeutically relevant dose level (20 mg).~   "
33497|NCT02618616|"~     This will be a randomized, double blind, placebo controlled, parallel group study in~     approximately 120 subjects with moderate to severe psoriasis with a PASI score of at least~     10. Following run-in subjects will be randomized to receive either oral 30 mg ZPL-3893787~     once daily or placebo once daily for 12 weeks.~   "
33498|NCT02618603|"~     Shoulder pain after stroke is a very common, causing significant morbidity disease.~     Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the~     shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain~     therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural~     modification. Unfortunately, these therapy methods may not be effective in many patients and~     long term benefit after treatment is transient, the outcomes may also be incomplete or~     non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the~     acetylcholine at the neuromuscular junctions but also other neurotransmitters such as~     glutamate, substance P and calcitonin gene related peptide, all of which have been indicated~     in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle~     spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to~     examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory~     shoulder pain after stroke.~   "
33500|NCT02618577|"~     NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised,~     multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation~     using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic~     embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors~     but without AF. The trial will be conducted in several European countries.~   "
33502|NCT02618551|"~     Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the~     thickness of bronchial muscle by heat using a catheter inserted into the bronchi under~     direct vision with the help of an endoscope This treatment has shown efficacy on symptoms,~     quality of life and the number of exacerbations related to severe asthma.~      This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation~     phenomenon (worsening of bronchial obstruction during exercise in patients with asthma~     contributing to worsening shortness of breath).~   "
33503|NCT02618538|"~     Some women have a higher risk than others of developing breast cancer. Unhealthy lifestyles,~     high breast density, family history, obesity, the presence of biomarkers associated with~     early neoplastic changes (considered alone or in combination) are just some of main factors~     that can increase the risk of breast cancer. Women with a higher risk may need to undergo~     more intensive screening activities, which include more frequent inspections and the~     possibility of experiment different types of tests. Instead, low risk women could be~     screened at longer intervals in order to reduce the screening harms (false positive results,~     overdiagnosis, radiation exposure, discomfort caused by the test itself, etc.) The ANDROMEDA~     Study aims at creating the possibility to customize the screening paths through a combined~     analysis of the above mentioned risk factors. Women consenting to be involved in the study~     will be asked to provide information on their lifestyle habits and reproductive history.~     Furthermore a blood sample will be collected for further bio-molecular analysis purposes.~   "
33504|NCT02618525|"~     BACKGROUND AND OBJECTIVES~      The purpose of this study is to assess whether the loss of motor response to supraorbital~     pressure can be an alternative to that of jaw thrust to predict optimal condition for~     laryngeal mask airway (LMA) insertion in children.~      METHODOLOGY~      Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that~     required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n =~     25) or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a~     standard anesthetic. When motor response to the study intervention was absent, the LMA was~     inserted. Outcome parameters were ease of mouth opening, LMA insertion score, requirement of~     additional propofol to increase the depth of anesthesia, occurrence of coughing, swallowing,~     laryngospasm and gross purposeful movements during or within one minute of LMA insertion,~     and the number of failed insertions.~   "
33505|NCT02618512|"~     This study is to evaluate the safety and tolerability of intravenous (IV) administration of~     SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis~     III, type B (MPS IIIB, Sanfilippo B) who participated in the NGLU-CL01 study. The NGLU-CL01~     study was a non-interventional study that evaluated structural brain abnormalities and blood~     brain barrier (BBB) integrity by magnetic resonance imaging (MRI) and cerebrospinal~     fluid/serum albumin index.~   "
33506|NCT02618499|"~     The purpose of this study is to determine if oxytocin administration immediately after~     delivery of the infant modifies the volume of placental transfusion in healthy term infants.~   "
33507|NCT02618486|"~     The investigators' earlier study reported a high prevalence of chronic periodontitis among~     obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to~     effectively reduce microbial load and contributes to reduction in periodontal parameters and~     inflammatory burden up to 6 months post-therapy. This study will cast light on the effects~     of obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the~     study were to quantify and to compare the periodontal pathogens, serum and salivary~     interleukins in obese and non obese with CP following NSPT.~   "
33508|NCT02618473|"~     The aim of this study was to investigate the effect of a new motion correction algorithm on~     image quality and diagnostic utility in unselected patients undergoing coronary cardiac~     computed tomography, and to investigate if this motion correction algorithm can compensate~     for the usual use of intravenously medication (beta-blockers) before the scan.~   "
33509|NCT02618460|"~     Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.~      Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood~     Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA),~     phase-contrast MRI), which could be used in combination with structural MRI in a single~     acquisition session, have been identified to investigate in more detail renal function and~     structure, opening the possibility to estimate local renal diffusion and blood perfusion,~     beyond providing high-resolution anatomical accuracy.~      Preliminary to the identification of novel imaging biomarkers of renal disease progression,~     perfusion and diffusion MR sequences need to be optimized for the renal compartment.~     Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and~     diffusion changes in pathological kidneys as compared to normal and physiological condition.~      The objective of this study is to provide normal control NCE-MRI sequences to be used as~     reference for the investigation of perfusion and diffusion changes in the kidney of patients~     affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal~     dominant polycystic kidney disease).~   "
33510|NCT02618447|"~     The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance~     Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function~     and hypertrophic potential in patients with liver cancer presenting for portal vein~     embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that~     could help determine which patients could safely and successfully undergo PVE and subsequent~     resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the~     investigators will validate the flow findings. Further regression/correlation analysis with~     functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis,~     histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to~     predict functional status and hypertrophic potential of the liver prior to PVE and~     hepatectomy allowing for better patient selection and reduced morbidity/mortality.~   "
33511|NCT02618434|"~     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810~     in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity~     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged~     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.~     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.~     Additionally, the severity and improvement in impulsive aggression, and quality of life~     measures for the subject and caregiver will be assessed using validated scales.~   "
33513|NCT02618408|"~     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810~     in the treatment of impulsive aggression in subjects with Attention Deficit/Hyperactivity~     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged~     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.~     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.~     Additionally, the severity and improvement in impulsive aggression, and quality of life~     measures for the subject and caregiver will be assessed using validated scales.~   "
33514|NCT02618395|"~     Bioavailability study~   "
33515|NCT02618382|"~     This is a single center single arm study of 50 patients to 1) determine the safety of~     tranexamic acid in the chronic subdural hematoma population following surgical drainage of~     chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the~     rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will~     be compared to historical controls. This study intends to be a prerequisite to a large~     nationally funded randomized control trial.~   "
33516|NCT02618369|"~     The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in~     patients with painful osteoid osteoma and other benign bone tumors, and in reducing their~     pain medication usage. No serious adverse effects are expected to result from this~     treatment.~   "
33517|NCT02618356|"~     The primary endpoint is to evaluate the Median disease progression free survival (mPFS).~   "
33518|NCT02618343|"~     Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment~     that is often treated with oral or intravenous anti-emetic medications. Research~     Design/Plan: This will be a randomized equivalence study comparing the reduction in a~     patient's reported level of nausea after treatment with either Ondansetron or IPA Methods:~     Patients who report nausea and/or vomiting in the normal evaluation and care of after~     calling 911 for Emergency Medical Care will be offered enrollment in the study. A short~     script will be attached to the outside of each study packet providing information about the~     study and its risks and benefits. Verbal or written (waiver of informed consent will be~     requested) permission will be obtained to start randomization. If the patient agrees to~     enroll then the study packet will be opened and utilized. All Advanced Life Support~     Ambulances in the San Antonio Fire Department will have sealed numbered opaque boxes or~     envelopes with either: 70% Isopropyl Alcohol swabs or ondansetron. Six Visual Nausea~     Severity Scoring cards will be provided with a marking pen to record timed nausea levels~     before and upon arrival to the Emergency Department and 15 minutes after treatment whichever~     comes first.~      Clinical Relevance: This treatment has not been studied in the unique environment~     encountered by Paramedics in the Pre-Hospital setting. If this treatment is found to be~     effective, it many offer a very simple, extremely inexpensive and non-invasive (basic life~     support) approach for the treatment of nausea.~   "
33519|NCT02618330|"~     The aims of this study were to compare health related quality of life, comforts~     degrees，retention effectiveness, and failure rates as well as survival times between two~     clear overlay retainers with different thicknesses, thus to provide basis information~     regarding appropriate selections of the thickness of clear overlay retainers.~   "
33520|NCT02618317|"~     Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly~     prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H)~     catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI~     incidence remains high. The purpose of this study was to evaluate two lock solutions on~     reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic~     minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other,~     trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus~     H.~      Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis~     (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil)~     were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions~     concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both~     investigators and patients were blinded to treatment allocation. The primary end-point was a~     10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding~     and lock solution-related adverse events were the primary safety end points. Logistic~     Regression was performed to evaluate differences in PF rates among the treatments (SPSS~     version 13.0, IBM, USA).~      Based upon the pilot-study data, the clinical trials has being executed in order to verify~     whether the three lock solutions have the same performance or not.~   "
33521|NCT02618304|"~     In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness~     and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or~     4 meibomian gland dysfunction, participants will be treated using conventional treatment~     modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic~     examination, tear-film lipid layer thickness, and ocular aberration are going to measured~     and compared.~   "
33522|NCT02618291|"~     This study aims to test the efficacy of a comprehensive assessment and management tool (AGE:~     Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in~     elderly patients followed in family medicine. Family practitioners will be randomised either~     to the intervention, consisting of a yearly screening for eight geriatric syndromes~     accompanied by a management plan in case of positive screening, or to usual care. Level of~     functioning and quality of life of patients in both arms will be assessed over two years.~   "
33523|NCT02618278|"~     This study aims to evaluate the whether receiving physiotherapy early after onset of the~     problem is better than waiting a few weeks to see if it gets better before starting~     physiotherapy. 80 people with sciatica will take part in the study, half of which will~     receive physiotherapy 2 weeks after seeing their G.P. The other half will receive~     physiotherapy at the usual time, around 6 weeks after seeing their G.P.~   "
33524|NCT02618265|"~     The investigators want to verify whether mobile application based on stroke strengthen~     prevention management is more effective than traditional management model or open stroke~     management platform. Whole blood-impedance based platelet aggregation(WBA) method and~     VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized~     anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary~     measure outcomes are change of the stroke recurrence rate and mortality after secondary~     prevention.~   "
33525|NCT02618252|"~     Patients with difficulty intravenous access frequently have delay of care in emergency~     departments because Emergency Department (ED) personnel could not establish intravenous (IV)~     access for diagnostic blood test or treatment. The ultrasound machine or near-infrared~     devices have been used to improve this situation but no study has ever compared which~     machine is more efficient. This study is designed to investigate whether the ultrasound or~     Vein Viewer, which is a near-infrared device, is more efficient.~   "
33526|NCT02618239|"~     Non-absorbable, fermentable residues in the diet increase intestinal gas production and~     induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however,~     prebiotics, which are also fermented by colonic bacteria have been shown to improve this~     type of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota~     and colonic biomass induced by prebiotics.~      Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d)~     for 3 weeks; they will also receive a standard diet during three days. The following~     outcomes will be measured immediately before, at the beginning and at the end of the~     treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, by~     means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after~     a test meal, by means of a barostat; c) microbiota composition by fecal analysis.~   "
33527|NCT02618226|"~     Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index~     study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring~     as the reference standard.~   "
33528|NCT02618213|"~     Bronchiolitis in infants and young children often requires respiraty support. In Denmark~     Continous Positive Airway Pressure ( CPAP) are routinely used in children with~     moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow~     Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children~     with bronchiolitis.~      Infants and young children with moderate-severe bronchiolitis and are randomized to either~     CPAP or HFOT.~   "
33529|NCT02618200|"~     Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic~     (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive~     cancer foci non-invasively, but additional progress is needed for the technique to be~     accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can~     improve the detection of cancerous tumors. As a first step in this direction, we need to~     create a database with MR images, 3D ultrasound images, and corresponding histopathology~     results, in patients treated by radical prostatectomy for prostate cancer. This is the~     purpose of the present study.~      In a later stage (outside the scope of this study), we will be learning how to combine these~     images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD~     system, and we will assess the performance of the new CAD. We expect this future system to~     improve the detection of prostate cancer and to reduce the number of patients requiring~     biopsy.~   "
33530|NCT02618187|"~     A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of~     SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.~   "
33531|NCT02618174|"~     Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests~     that using social-based information might help. For instance, it has been shown that if~     people think that others are eating lots of fruit and vegetables, that they will consume~     more of these foods to match the 'norm'. The purpose of this study was to determine whether~     a liking social norm (information about how much others like vegetables) would be effective~     at encouraging people to eat more vegetables and to examine whether these effects are~     sustained beyond initial exposure (i.e. whether the effect of the norm persists on food~     selection 24 hours alter).~   "
33532|NCT02618161|"~     TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate~     CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility~     trial.~      SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014~     Study Duration Recruitment Duration 18-24 months~      Study Centre Southend University Hospital NHS Foundation Trust~      Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual~     dysfunction at various time points.~      Number of Participants 50 participants~      Main Inclusion Criteria~        -  Patient age >18 years~        -  Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0~        -  Any Gleason score~        -  Any PSA level~        -  Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous~          TURP/HoLEP Laser Prostatectomy~        -  Any Metastatic Disease~        -  IPSS>20~        -  Pubic arch interference~        -  Lithotomy position or anaesthesia not possible~        -  Rectal fistula~        -  Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse~          events will be compared using Fisher's Exact Test. Toxicity score means will be~          compared using two-sample permutation t-tests, and PSA relapse-free survival will be~          estimated using Kaplan-Meier and compared using log-rank tests.~   "
33533|NCT02618148|"~     The purpose of this study is to determine whether safety Study of Hormone replacement~     therapy (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in~     perimenopausal and postmenopausal women.~   "
33534|NCT02618135|"~     This project involves creating a novel and personalised BCI training system that targets~     social and communication difficulties, and inattentive symptoms problems often found in~     ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they~     will undergo 24 training sessions over an 8-week period. During these sessions, the children~     will play a computer game interface specifically designed to train attention and facial and~     emotional recognition, while using our BCI device. To further reinforce the treatment, the~     training system has been enhanced with the inclusion of an eye-tracker to target the lack of~     preferential eye contact that children with ASD exhibit. The investigators hypothesize that~     participants will show improvements in social skills and attention post treatment.~   "
33535|NCT02618122|"~     This non-interventional study aims primarily at assessing the clinical effectiveness and the~     impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it~     represents an attempt towards gaining experience on the routine use of trabectedin in daily~     clinical practice in a representative sample of Greek subjects with aSTS.~   "
38244|NCT02556476|"~     The purpose of this study was to examine the cost effectiveness of critical care in a middle~     income country with limited resources.~      The main study hypothesis was that critical care is cost effective in low resources setting.~   "
33536|NCT02618109|"~     B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite~     enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies~     in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells~     -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was~     associated with poor response to chemotherapy. However, few studies have been done on~     childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B~     cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its~     significance has never been evaluated in human cancers. The purpose of this study is to~     prospectively evaluate the immune status of children newly diagnosed with first relapse of~     B-cell ALL, and to compare results with those of children treated for B-ALL in complete~     remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg~     cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T~     cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of~     immunosuppressive cells proportions could be associated with B-ALL relapse.~   "
33537|NCT02618096|"~     The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus~     dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.~   "
33538|NCT02618083|"~     Retinal detachments correspond to a separation of the neuroepithelium from the pigment~     epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional,~     traumatic (postoperative) or rhegmatogenous (in relation to a tear).~      Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile~     membrane. It can also measure the hemodynamic parameters of retinal arteries.~      A preliminary study showed a correlation between systolic velocity in the central retinal~     artery and postoperative visual acuity.~      The aim of this study is to confirm those preliminary data.~   "
33539|NCT02618070|"~     In this functional magnetic resonance imaging study, effects of different information of fat~     content of high or low fat will be examined in FD patients and healthy volunteers (n=30,~     respectively). These data will provide a better understanding of symptom generation~     following food ingestion in general as well as in patients with respective functional~     gastrointestinal disorders.~   "
33540|NCT02618057|"~     Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in~     children. The clinical course is typically self-limited and benign; however, rare cases of~     severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim~     to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar~     consolidation or pleural effusion in children.~   "
33541|NCT02618044|"~     Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of~     choice for patients suffering of gastro-esophageal reflux (GER). However, long term~     instrumental evaluations of GER after LRYGB are not available.~      The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric~     Bypass (LRYGB) on gastro-esophageal function.~   "
33542|NCT02618031|"~     This study seeks to investigate the capillary index score (CIS) to further improve patient~     selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).~      The hypothesis or idea being tested:~      Patients with favorable CIS who are successfully revascularized with EVT can have successful~     outcomes with an extended time window for treatment.~   "
33543|NCT02618018|"~     The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M~     4-haptic toric IOL in cataract surgery.~   "
33544|NCT02618005|"~     Human immune function and intestinal microbiota are suggested to be altered within~     long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei~     strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and~     intestinal microbiota. This study aims to investigate the impact of long-duration~     spaceflight as well as intake of LcS on the international space station (ISS), on immune~     system and intestinal microbiota in astronauts.~   "
33545|NCT02617992|"~     The development of a standardised imaging protocol to detect post endoscopic mucosal~     resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the~     post EMR scar with endoscopic findings.~   "
33546|NCT02617979|"~     The study of readmission is in its infancy in the surgical world, and there are no~     prospective studies, to the investigators' knowledge, evaluating the efficacy of~     interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and~     their caregivers will play a key role in any useful intervention to reduce readmission.~     Therefore, the investigators' approach is to target perioperative education and engagement~     of patients and their caregivers in the postoperative recovery of pancreatectomy patients.~   "
33547|NCT02617966|"~     Background:~      Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss~     and night blindness. Researchers want to learn about rod and cone function in healthy people~     and people with retinal disease. They want to know if how well a person sees in the dark can~     test the severity of retinal disease.~      Objectives:~      To find out if how well a person sees in the dark can test the severity of retinal disease.~     To find out if this can help detect retinal disease and track its changes.~      Eligibility:~      People ages 5 and older with:~      Retinal disease OR~      20/20 vision or better with or without correction in at least one eye~      Design:~      Participants will be screened with medical and eye history and eye exam. Those with retinal~     disease will also have:~      Eye imaging: Drops dilate the eye and pictures are taken of it.~      Visual field testing: Participants look into a bowl and press a button when they see light.~      Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the~      dark with their eyes patched for 30 minutes. Then they get numbing drops and contact~      lenses. Participants watch lights while retina signals are recorded.~      Visit 1 will be 3 8 hours. Participants will have up to 6 more visits over 6 12 months.~     Visits include:~      Eye exam and imaging~      Time course of dark adaptation: Participants view a background light for 5 minutes then~      push a button when they see colored light.~      Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button~     when~      they see colored light.~      For participants with retinal disease, ERG and visual field testing~   "
33548|NCT02617953|"~     Investigation of objective tinnitus diagnosis method through measurement of continuous~     resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation~     (rTMS) treatment of tinnitus.~   "
33549|NCT02617940|"~     The aim of this study is to evaluate the efficacy of oral hygiene orientation singly,~     compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary~     and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal~     surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion~     will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups:~     oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and~     12 months regarding clinical and radiographic lesions progression. The costs and~     cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction~     and impact on quality of life will also be investigated. Poisson regression analysis will be~     performed in order to compare the groups, through clinical and radiographic criteria. This~     test will also be used to assess the association between the group and patient discomfort~     and parents' satisfaction. Time, costs and impact on quality of life of the treatments will~     be compared by Student's t test. For all analyses, the significance level will be set at 5%.~   "
33550|NCT02617927|"~     The safety assessment of Vedolizumab during pregnancy in IBD patients.~      The primary objective of this study is:~        1. To quantify incidence of major structural birth defects and other birth outcomes in~          infants born to women with UC/CD with exposure to Entyvio compared to women with~          exposure to other biological agents or conventional IBD therapy during pregnancy~        2. To assess the health and developmental status of infants up to 1yr of age.~   "
33551|NCT02617914|"~     The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients~     affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive~     mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up~     to 48% and consumes large amounts of critical care resources. ARDS patients often present~     with severe hypoxemia that is refractory to conventional treatment and are thus evaluated~     for extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the~     appropriate indication for ECMO and clinical evidence for ECMO as a rescue treatment are~     still controversial. In 2012 Grasso and colleagues therefore presented a case series of~     influenza A (H1N1) ARDS patients describing the use of esophageal pressure measurements for~     individualized PEEP titration to achieve an end expiratory plateau pressure of the lung~     (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings~     could be adjusted in half of these patients by increasing PEEP which resulted in an increase~     of oxygenation measures to an extend that criteria for extracorporeal support where no~     longer met and conventional treatment with invasive mechanical ventilation could be~     continued. However, uncertainty remains as to whether these results are generalizable to~     ARDS of any cause. In addition, increasing PEEP might impact on cardiac function and might~     therefore be associated with clinical important hemodynamic effects in these patients.~      The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which~     an individualized PEEP treatment strategy can be employed. ARDS will be defined and~     stratified according to the Berlin ARDS definition. A naso-gastric probe capable of~     measuring esophageal pressure will be inserted directly after admission to the ICU as~     previously described. Invasive mechanical ventilation and oesophageal pressure measurements~     will be done using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters~     (Edwards CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output,~     pulmonary artery pressures and left atrial pressures. Volumetric parameters will be measured~     using tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be~     addressed in addition by the use of a predefined echocardiography protocol.~   "
33552|NCT02617901|"~     The Greulich and Pyle technique (G&P) is that most commonly used to assess bone age in~     children, particularly in the context of suspected skeletal dysplasia. However it has been~     shown not to be applicable to children of Asian and African ethnicity and may not be~     applicable to United Kingdom (UK) Caucasian children, who are now relatively more mature and~     larger than children of the mid 1930's (when G&P was developed). It is generally agreed that~     updated standards are required for rapid and reliable bone age assessment. The development~     of such standards requires irradiation of normal children. To do this ethically, radiation~     exposure must be kept as low as possible. Two recent studies suggest that bone age~     assessment can be reliably achieved from dual-energy x-ray absorptiometry (DXA) scans. As~     far as the investigators are aware, the Tanner & Whitehouse (TW3) method, which is preferred~     by some (e.g. endocrinologists and nutritionists), has not been assessed from dual-energy~     x-ray absorptiometry (DXA) scans - although not the main focus of this study, because of its~     popularity amongst certain specialties, the investigators shall be assessing the TW3 method~     also. Modern techniques should not only be available as textbooks, but should also be~     available in digital (on-line) format and where possible integrated with hospital PACS~     systems. The investigators believe that their team has the required experience and expertise~     to successfully carry out such a project. Before conducting the required large~     cross-sectional study, the investigators must first confirm that DXA can in fact replace~     radiographs for bone age assessment in children; which is the objective of this current~     study.~   "
33553|NCT02617888|"~     Purpose~        1. To investigate the effects of cardiac imaging radiation on the induction of DNA~          double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked~          hair follicle cells.~        2. To estimate whether the use of breast shields in cardiac computed tomographic~          angiography (CCTA) limits the effective radiation exposure of breast tissue.~   "
33554|NCT02617875|"~     The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic~     multifunctional teleconsultation system. This system consists of on-line transmissions of~     vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a~     trained emergency physician (tele-EMS physician) uses software-based guideline conform~     algorithms for diagnosis and treatment.~      At the prehospital emergency scene half of the patients will receive this telemedicine-based~     approach and the other half the conventional emergency physician-based care.~   "
33555|NCT02617862|"~     The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA)~     to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical~     Incorporated (PCI) (Pleasanton, CA).~   "
33556|NCT02617849|"~     This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in~     combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or~     metastatic melanoma.~   "
33557|NCT02617823|"~     The purpose of this study is to determine if a lateral positioning of the pregnant woman~     after epidural analgesia increases the incidence of unilateral functioning epidurals.~   "
33558|NCT02617810|"~     The purpose of this study is to evaluate effect of multiple-dose administration of~     JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose~     pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of~     racemic warfarin.~   "
33681|NCT02616211|"~     Patients are asked to participate in this study if they have been diagnosed with a thoracic~     carcinoma which includes lung cancer and have a gene mutation (alteration in the body's~     genetic instructions) and after undergoing treatment the cancer has come back, progressed,~     or shown a partial response on standard treatment.~   "
33559|NCT02617797|"~     Urinary stress incontinence ( SUI ) is defined as an involuntary loss of urinary Complaint~     no effort According to the Consensus of the International Continence Society (Society~     Continene International - ICS) . SUI Prevalence of adult female Population and 25 % to 30~     %.However, despite the high prevalence, many women who have symptoms of SUI or not seek~     treatment remain without resolution of symptoms.Then there is the possibility of using~     non-invasive radiofrequency and non-ablation in external urethral meatus in order to~     stimulate collagen production, as one of the pathophysiological mechanisms of stress urinary~     incontinence is the collagen deficit in the urethral wall. It is a randomized clinical trial~     and the group experimental will utilize radiofrequency and cinesioteraphy ( clinical and in~     home) and the group control utilize turn off- radiofrequency and cinesiotherapy(clinical and~     in home). The protocol f the cinesiotherapu is the same both the group, and the protocol~     radiofrequency the group experimental will 5 sessions (one per week) with temperature 38ºC~     during 2 minuts. The group control will 5 sessions (one per week) but the radiofrequency~     will off but glycerin is heated, for masking for the patient, during 2 min. The result of~     the treatment is assessed by pad test 1 hour and have others outcomes ( quality of life-~     Sf-26 ans King Health- and sexual function- FSFI questionaire)~   "
33560|NCT02617784|"~     This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its~     metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for~     end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed~     oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.~   "
33561|NCT02617771|"~     Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D~     supplementation in children with RRI, with no conclusive information.~      Therefore, we designed a prospective, single-blind, clinical trial to evaluate whether oral~     supplementation with vitamin D from October to April reduces the global health burden of~     recurrent respiratory tract infections in a primary care setting.~      The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can~     reduce the number of respiratory tract infections in children diagnosed with recurrent~     respiratory tract infections the seasons before.~      Secondary objectives was the assessment of Vitamin D supplementation benefits on global~     socioeconomic burden of recurrent respiratory tract infections in a primary care setting,~     according to number of visits to the primary care paediatrician and use of antibiotics due~     to respiratory tract infections.~   "
33562|NCT02617758|"~     The purpose of this study is to evaluate the bioequivalence of the new formulation of~     fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy~     participants.~   "
33563|NCT02617745|"~     The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed~     in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied~     parameter is the variation in platelet count during the radio-chemotherapy phase. The main~     objective is to identify early in Stupp protocol a group of patients having high risk to~     undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm~     of platelet monitoring for patients treated with Stupp protocol wil be proposed.~   "
33564|NCT02617732|"~     The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose~     variability in patients with type 2 diabetes by continuous blood glucose monitoring system.~   "
33565|NCT02617719|"~     Comprehensive Geriatric Assessment is an effective process to identify and address the needs~     of older patients. In the United Kingdom this usually takes place in acute care or in the~     patients home. This project will assess the feasibility of implementing this service in~     primary care.~   "
33566|NCT02617706|"~     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site~     infections (SSI).~   "
33567|NCT02617693|"~     This study is conducted in Asia. The aim of this study is to assess the efficacy of a~     pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.~   "
33568|NCT02617680|"~     There is accumulating evidence that inappropriate depth of anaesthesia is associated with~     increased risk of postoperative complications including risk of death. The aim of this study~     was to identify factors determining the effective end-tidal concentration (EEtC) of~     desflurane, duration of wash in and wash out phase, and to estimate the risk of~     perioperative awareness in patients undergoing elective neurosurgical procedure.~   "
33569|NCT02617667|"~     The objective of this study is to compare the safety, efficacy, and tolerability of two~     different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for~     the treatment of the signs and symptoms of Dry Eye Disease (DED).~   "
33570|NCT02617654|"~     Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin~     production, albeit at low levels. Finding means to increase this production would be of~     tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have~     been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the~     risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events~     and late complications. Liraglutide may through its incretin effect directly potentiate~     beta-cell function, but also holds the potential to be mitogenic for these cells.~      The hypothesis of the present trial is that treatment with liraglutide will not only have a~     direct effect on beta-cell function, which is more or less immediately observed, but also~     progressively improve C-peptide concentrations over time.~   "
33571|NCT02617641|"~     Acute coronary syndromes (ACS) are one of the leading causes of coronary artery disease~     mortality, and among the top reasons for health care utilization in Canada. Physical~     activity counselling is a core component of secondary prevention interventions because~     increased physical activity is associated with reduced mortality risk, improved quality of~     life, reduced coronary risk factors, and reduced health care utilization. Despite these~     health benefits, between 40% and 60% of patients after an ACS event are insufficiently~     active. Web-based interventions offer innovative alternatives for intervention delivery via~     the Internet in secondary prevention. However, there is a paucity of randomized controlled~     trials testing, in ACS patients, computer-tailored interventions that include videos within~     the tailored algorithm. The purpose of this multicenter randomized controlled trial is to~     test a web-based intervention, TAVIEenM@RCHE, that uses tailored-videos of a nurse, the~     'virtual nurse', aimed at increasing physical activity through walking in ACS patients.~   "
33572|NCT02617628|"~     This study is a collaboration between the University of Pennsylvania, the Philadelphia~     Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the~     impact of an injectable opiate addiction medication (extended release naltrexone) given~     before reentry into the community that might help to improve reconnection to healthcare and~     other support systems, and possibly help reduce recidivism.~   "
33573|NCT02617615|"~     A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate~     the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral~     Doses of MB-110 in Healthy Volunteers and to Evaluate the Antiviral Activity of MB-110 in~     Hepatitis C Virus Infected Subjects~   "
33574|NCT02617602|"~     Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular~     performance and allows for timely interventions based on predetermined algorithms. The aim~     of this prospective randomised study is to evaluate the effect of GDT on major complications~     in children undergoing radical correction of congenital heart defects, complicated by acute~     heart failure. Goal directed therapy will be implemented with the aid of transpulmonary~     thermodilution and based on predetermined algorithms.~   "
33575|NCT02617589|"~     The main purpose of this study is to compare how long patients with glioblastoma (GBM, a~     malignant brain cancer) live after receiving nivolumab every two weeks in addition to~     radiation therapy (RT), and then every four weeks, compared with patients receiving standard~     therapy with temozolomide in addition to RT.~   "
33576|NCT02617576|"~     To determine if patient satisfaction, participation, and image quality improves with~     flavored oral contrast for MR enterography.~   "
33577|NCT02617563|"~     The purpose of this study is~        -  to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior~          approaches in patients with spondylolisthesis (≥ grade I).~        -  To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion~          procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar~          Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar~          Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar~          Interbody Fusion) are used in surgical practice and to describe long-term safety and~          effectiveness in a broad patient population of patients with degenerative lumbar disc~          disease .~   "
33578|NCT02617550|"~     This study is intended to investigate the effect of nitroglycerin on vericiguat in patients~     with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat~     acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs~     in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is~     important to investigate the safety and tolerability of vericiguat and nitroglycerin, which~     may be used as unprescribed on-demand treatment by patients with acute episodes of angina~     pectoris.~   "
33579|NCT02617537|"~     The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as~     betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to~     appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a~     placebo-controlled comparative study~   "
33580|NCT02617524|"~     Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the~     feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic~     Valvuloplasty (BAV).~   "
33581|NCT02617511|"~     The purpose of this project is to evaluate whether omega-3 fatty acid supplementation~     (combined eicosapentaenoic acid and docosahexaenoic acid [EPA/DHA] supplement) augments the~     effects of a 12-week resistance training program in older men. Outcome variables include~     inflammatory biomarkers in the systemic circulation, body composition and performance~     measures. The specific inflammatory markers in the blood include: C-reactive protein, tumor~     necrosis factor-α, interleukin-1β, and interleukin-6. Remaining parameters include: body~     composition (as assessed by dual energy x-ray absorptiometry), muscle strength (as assessed~     by chest press and leg press one-repetition maximum strength tests), and functional ability~     (as assessed by timed up and go test as well as the 6-minute walking test).~   "
33582|NCT02617498|"~     Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included~     in this a prospective study.Patients enrolled in the study divided into two groups according~     to the day of surgery. The study population was divided into two groups; group (A)~     Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B)~     Parenchymal liver transection was performed by spray diathermy (SD).~   "
33583|NCT02617485|"~     The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20~     (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients~     with CD20-positive diffuse large B-cell lymphoma.~   "
33584|NCT02617472|"~     This study will assess the effectiveness of a new pelvic floor exercise device in~     strengthening pelvic floor muscles and treating urinary incontinence among women who are~     experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks~     and results will be collected through self-assessment questionnaires and clinical pelvic~     examination. Effectiveness outcomes will be tracked over the duration of the trial and~     measured against historical symptoms.~   "
33585|NCT02617459|"~     To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.~   "
33586|NCT02617446|"~     To Assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5~     and 1.0 µg/kg/min), a new agent with lusitropic and inotropic activities that improves the~     cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will~     be infused i. v. for 24 hours in comparison with placebo, in treatment of Chinese and~     Italian patients with Acute Decompensated Heart Failure. In all the Italian patients and in~     a subset of Chinese patients pharmacokinetics and metabolism of istaroxime shall also be~     studied.~   "
33587|NCT02617433|"~     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis~     of the affected skeletal muscles. There have been several studies reported positive~     relationship between muscle mass and amount of neuromuscular junction. The purpose of this~     study is to find relationship between muscle mass and muscle relaxation time.~   "
33588|NCT02617420|"~     This study plans to learn more about how children use their asthma medicines. The~     investigators would like to see if special electronic monitoring devices that connect to~     smartphones and computers can help children to better manage their asthma~   "
33589|NCT02617407|"~     Children undergoing Hematopoietic Stem Cell Transplantation (HSCT) have significant~     difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a~     significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective~     in reducing dental plaques while containing no additives found in other toothpastes that can~     cause increased gingival irritation. The investigators hypothesize that improved oral~     hygiene in HSCT recipients and better plaque control may result in reduced oral~     inflammation, decreased amount of oral bacterial pathogens, and reduced risk of~     oral-pathogen related systemic bacterial infections. The overall goal of this prospective~     randomized (2:1) pilot study is to determine whether incorporation of the Livionex®~     toothpaste in the research regimen could reduce dental plaque.~   "
33590|NCT02617394|"~     Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest~     that helps control breathing - is moving properly. If the diaphragm is paralyzed or not~     moving properly, this can affect a person's breathing. After certain nerve blocks - where a~     part of the body is frozen using local anesthetic - the nerve controlling diaphragm movement~     can be anesthetized, causing diaphragm paralysis. Ultrasound can be used to see the~     diaphragm and measure its movement, but the easiest and fastest way to do this is debatable.~     The investigators wish to compare two ultrasound-based methods to image diaphragm movement~     to see which one offers the quickest and easiest way to determine if the diaphragm is~     paralyzed.~   "
33591|NCT02617381|"~     This is not a validation study of a questionnaire. This is a multicenter diagnostic study,~     assessing the sensitivity and specificity of a simple structured questionnaire, to identify~     patients requiring further haemostatic investigations, in pre-operative patients. This study~     will also allow for the assessment of the sensitivity and specificity of the routine care~     strategy.~      All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in~     different anaesthetic sectors each day of the week, so that different types of surgery are~     represented.~      Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part~     in the study.~      Routine care strategy is not modified by the study protocol. In addition, the simple~     structured questionnaire will be completed by the patient with a research assistant after~     the pre-operative consultation As recommended in diagnostic studies, the gold standard (see~     secondary endpoint paragraph) will be performed consistently in all patients to avoid~     verification bias.~      The improvement of screening for the need of further investigations by use of the~     questionnaire compared to routine care will be measured counting how many patients are~     adequately reclassified with the questionnaire compared to the routine care strategy,~     regarding the gold standard (using the Net Reclassification Index).~   "
33592|NCT02617368|"~     Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of~     keratometric data in differentiating moderate KC and FFK from healthy corneas.~      Study participants were recruited from the Cornea Outpatient service in a consecutive if~     eligible basis. Two study groups were formed: a)KC group included patients those were~     diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich~     classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c)~     Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR,~     Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same~     experienced operator in a consistent way.~   "
33593|NCT02617355|"~     This study is designed to compare a new prototype surgical magnetic drape made with~     bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.~   "
33594|NCT02617342|"~     This study is being done to examine the impact of an interactive, social robotics program in~     helping children with autism spectrum disorders (ASD) understand emotions and how to better~     recognize emotions while interacting with others. Eligible families will be randomized to~     either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14~     weeks. Assessments will occur at pre- and post-intervention as well as weekly for both~     conditions.~   "
33595|NCT02617329|"~     The purpose of this research was to investigate the clinical effects on the ESWT treatment~     of shoulder and neck pain.~   "
33596|NCT02617316|"~     The purpose of this research is to investigate the differences of landing patterns while~     running in different speed with barefoot and wearing shoe.~   "
33597|NCT02617303|"~     Falls are an important risk factor for fragility fractures. Both are associated with the~     ageing process and as they rise also increase the risk of mortality, disability and~     dependency. Interventions to prevent falls have been based on multifactorial approaches but~     the outcomes have shown little effectiveness. Lately, it is being recommended interventions~     which foster physical exercise incorporating it to daily life activities. The OTAGO exercise~     programme is based on easy physical exercises for older adults and has shown cost-effective~     outcomes for falls prevention and its consequences.~   "
33598|NCT02617290|"~     The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®)~     have shown promising results in the respective TRITON and PLATO trials making of prasugrel~     and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC~     Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS~     patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of~     stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the~     reduction in death in a meta-analysis.~      The field of elective PCI (stable patients) has not been studied with these 2 new drugs and~     clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor~     is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple~     stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported~     by scientific evidence. More than half of PCI patients undergo elective stenting for proven~     ischemia and/or stable angina, a relatively safe procedure with the use of the latest~     generation of stents. However complications remain either frequent when considering~     PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients~     or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for~     improvement with these two newest drugs.~      The investigators propose to perform a multicenter international study in stable patients~     undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The~     investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor~     over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and~     myocardial injury) without significant excess bleeding (BARC definition).~   "
33599|NCT02617277|"~     This study will assess the safety, tolerability and pharmacokinetics of AZD1775 given orally~     in combination with intravenous MEDI4736. Secondly, the immunogenicity, pharmacodynamics,~     and preliminary anti-tumour activity will be determined in patients with refractory solid~     tumours~   "
33600|NCT02617264|"~     To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with~     Spot at time of biopsy.~   "
33601|NCT02617251|"~     Many studies have shown that deprived patients consumed more healthcare resources than~     non-deprived patients, in particular in terms of increased length of stay (LOS) and~     readmission rates, which has an impact on hospital efficiency and the healthcare system as a~     whole. There are many types of indicators available to assess deprivation in a hospital~     setting and French decision makers are currently using reliance on public aids to allocate~     additional funding to hospitals, based on the percentage of deprived patients they admit.~     However there are limits to this method: it only assesses one dimension of deprivation, the~     target population often does not know about the existence of those aids, and they have a~     clear threshold effect. An alternative solution is to use ecological deprivation indices~     which are obtained by aggregating different variables measured at a specific time and place,~     i.e. the patient's place of residence at the time of care. One such index, the FDep , was~     developed specifically in France, although others such as the Carstairs index and the~     European deprivation index also exist.~      The primary objective of this study is to study the association between deprivation,~     measured by the FDep, and hospital care efficiency in paediatric and neonatology patients,~     measured by the difference between patient LOS and the national average LOS of their~     diagnosis-related group, DRG). The secondary objectives are to carry out a budget impact~     analysis on the impact of deprivation for hospitals with a paediatric or neonatology ward,~     to study the association between deprivation and readmission at 15 days, to study the~     relation between FDep and the currently used deprivation indicators, and to assess the added~     value of the FDep compared to those indicators and whether or not it should be used in~     routine practice.~      In order to do so, an exhaustive retrospective study using the French hospital claims~     database will be carried out for the years 2012-2014. Deprivation indices will be calculated~     based on patients' postcode. The primary endpoint will be calculated using the national LOS~     present in the French national cost study. Similarly, the budget impact will look at the~     difference between production costs derived from the national cost study after adjusting for~     LOS and the statutory health insurance's tariffs, which will allow us to assess whether a~     hospital stay is associated with a gain, a loss or is budget-neutral for the hospital.~     Readmissions at 15 days will be identified through record linkage.~      Descriptive analyses will summarise both hospital and patient characteristics. Uni- and~     bivariate analyses will be carried out by focusing of the variables of interest (e.g.~     average deprivation index by legal status of the hospital, mean LOS depending on the number~     of paediatric beds etc.). The deprivation index will be divided into quantiles as is the~     norm and the endpoints will be assessed for each of those quantiles. An ANOVA (or a~     Kruskal-Wallis test if the ANOVA hypotheses are not met) will test whether the results~     differ between each quantile. For readmission rates, a Chi² test will be performed.~      In order to study the association between deprivation and the endpoints, the investigators~     will model each endpoint using as the main explanatory variable the deprivation index. Three~     main types of explanatory variables will be added to the model: patient characteristics~     (age, sex, severity level etc.), hospital characteristics (legal status, size, number of~     full-time equivalent etc.) and environment/context characteristics (number of paediatricians~     for 1,000 inhabitants, rural vs. urban area etc.).~      In order to assess the added benefit of using the deprivation index vs. the current~     indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as~     unfortunately, whether the patient receives public aids is not present in the hospital claim~     database but is available only at the local level. The investigators will look at the~     distribution of patients with public aids in each quantile of the deprivation index and run~     the previous models using the two types of indicators one after the other and comparing the~     statistical performance of each pair of models.~   "
33602|NCT02617238|"~     Randomised two parallel groups multicenter study using a Prospective Randomised Open Blinded~     End-point design (PROBE), aiming at comparing the efficacy of a therapeutic strategy~     targeting the normalisation of arterial stiffness for reducing cardiovascular (CV) and renal~     events, in comparison with a classical therapeutic strategy implementing the European~     Society of Hypertension-European Society of Cardiology (ESH-ESC) Guidelines, in patients~     with essential hypertension and medium-to-very high CV risk.~   "
33603|NCT02617225|"~     The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba~     Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under~     their Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities,~     practices and institutionalize WASH in school settings. Under the WinS program, UNICEF~     piloted a group hand washing program in 100 elementary schools. Multiple past studies have~     shown that handwashing is an effective intervention to reduce diarrheal diseases and~     respiratory tract infections, but the evidence on the interventions or programs that can~     achieve this behavior change is mixed and limited in case of school setting. The main~     objective of Daily Handwashing for an Ailment-free Life (DHaAL) program was to~     institutionalize handwashing with soap before consuming mid-day meals and after using~     toilets among elementary school students. DHaAL is implemented on the Mid-day Meal platform~     where free meals are given to all students attending government schools.~      In addition to the standard DHaAL intervention, several pilot phase schools also received an~     additional program for a holistic and participatory development of school systems for~     health, nutrition, learning outcomes and wellbeing of children called Child Friendly School~     System (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes~     and offer longer support from and implementing agencies which help DHaAL Intervention also.~      This evaluation study seeks to answer whether DHaAL improved handwashing practice before the~     mid-day meals in rural lower primary schools as a primary research question. The~     intermediate outputs and secondary outcomes evaluated in this study include functionality of~     handwashing infrastructure at school, handwashing practice after toilet use, and~     availability of and use of handwashing facilities at homes (indirect effect). The evaluation~     study has other supplemental operations research objectives to help improve the program in~     future.~   "
33604|NCT02617212|"~     The purpose of this study is to investigate whether the immediate definitive abutment~     connection to dental implant is effective in preventing marginal bone loss when compared to~     the conventional treatment with late abutment/implant connection, which include three~     disconnections and reconnections.~   "
33605|NCT02617199|"~     Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood~     flow in the pancreatic microcirculation. It seems to be the main cause of the~     pathophysiology of acute pancreatitis. Today, there have been many attempts in the~     management of pancreatitis but no established management seems to be ideal. The epidural~     block is an anesthetic technique used to provide highly peri and post-operative analgesia,~     also plays an important role in improving the gastrointestinal vascular perfusion (due to~     sympathetic blockade that this technique produces) so this anesthetic technique is proposed~     as an alternative to both clinical treatment as an analgesic for acute pancreatitis.~   "
33606|NCT02617186|"~     During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera~     attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted~     via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS)~     uses a similar minimally invasive approach, but the very precise instruments involved with~     RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the~     surgeons increased range of motion during the surgery, and research demonstrates that RTS~     has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better~     results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy~     has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a~     prospective manner.~      There are two major barriers against the widespread adoption of robotic thoracic surgery.~     The first barrier is the lack of high-quality prospective data. To our knowledge, there are~     no prospective trials comparing VATS to RTS for early stage lung cancer. The second major~     barrier to the widespread adoption of robotic technology in thoracic surgery is the~     perceived higher cost of Robotic lobectomy. To address these barriers, the investigators~     will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to~     Robotic Lobectomy for early stage lung cancer.~      Prospective randomization will eliminate the biases of retrospective data and will serve to~     determine whether there exist any advantages to Health Related Quality of life (HRQOL) or~     patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a~     prospective cost-utility analysis, this trial will provide the highest quality data to~     evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian~     health system.~   "
33607|NCT02617173|"~     Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm~     quality is the cause of infertility in about 20% of couples with fertility problems, and a~     contributory factor in a further 25% of couples. In the majority of cases, no cause can be~     found. For mild male infertility, intra uterine insemination (IUI) is the procedure of~     choice with a pregnancy rate of 6.5%. In IUI, sperm is inserted using a thin, flexible~     catheter directly into a woman's uterus.~      Azoospermia affects 1% of the male population and 20% of male infertility situations. Over~     50% of azoospermic cases are due to testicular failure, including absence or failed~     production as well as low production and maturation arrest during the process of~     spermatogenesis. ICSI allows successful fertilization even with immature sperm obtained~     directly from testicular tissue. This is done through TESA (Testicular sperm aspiration) or~     TESE (Testicular sperm extraction). In cases of TESE small strips of testicular tissue are~     extracted with the intention of finding few viable sperm cells to be used for IVF or ICSI.~     Men with non-obstructive azoospermia have 0 to 3 mature spermatids per seminiferous tubule~     in contrast to 17-35 mature spermatids in men with normal spermatogenesis. TESE success~     rates are approximately 50% but differ according to etiology. Unfortunately, there is no~     method of pointing out where sperm may be found. TESE is accompanied with pain, tissue loss,~     reduced success in future TESE due to tissue scaring and testosterone deficiency.~      The complex process of spermatogenesis includes maturation of young spermatids into~     spermatozoas, a process which takes approximately 74 days. During spermatogenesis,~     spermatogonial stem cells are transformed into spermatids and released from the seminiferous~     tubule epithelium into its lumen. Non-motile spermatozoa are transported through the~     seminifreous tubules to the epididymis by testicular fluid secreted from the Sertoli cells~     with the aid of peristaltic contraction. During transport through the epididymis, sperm~     cells develop the ability to progress forward, undergo capacitation and attach and penetrate~     the egg.~      The electric charge of the spermatic cell has been termed zeta potential (electrokinetic~     potential) and is defined as the electric potential in the slip plane between the sperm~     membrane and its surroundings. Mature sperm possess an electric charge of −16 to −20 mV.~      In the animal study conducted, positive electrical current with a low amplitude bellow~     sensation level was situated around the scrotum of four normospermic and one oligospermic~     male pigs. At the end of the research the concentration of spermatocytes in the epididymis~     obtained in surgery was found to be 200 to 1600 percent above the baseline.~      Our intention is to evaluate if positive electrical current with a low amplitude bellow~     sensation level situated on the scrotum will increase the concentration of spermatocytes in~     the ejaculate.~      If our hypothesis is confirmed this may become a method for treating male infertility. The~     period of improvement is still unclear.~   "
33608|NCT02617160|"~     Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes.~     Utilizing pump therapy requires the development and application of a new spectrum of~     theoretical knowledge and practical skills by the patient. Furthermore, occasionally there~     is a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate~     ratio, basal plan and insulin activity time, in order to optimize and improve glucose~     control. These adjustments are based on collected information including insulin delivery,~     blood glucose measurements, continuous glucose monitoring data, meals and so on. Analyzing~     this multitude of information and data is overwhelming for many of the patients, caregivers~     and health care providers. Unfortunately, not all physicians have the needed expertise to~     fully fulfill this task, and for those who do, it is time consuming. Thus, a summary of the~     data with insulin dose adjustment suggestions is missing. An automated tool for pump setting~     adjustments will improve glycemic control without escalating the burden on patients and the~     health care system. Such advisor can assist the professional team during routine follow-up~     and the patients between visits.~      To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA),~     which automatically analyses treatment information, learns patient's needs and accordingly~     suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose~     monitoring, insulin dosing and meal data during daily routine home care. Following a 5~     minute data collection and analysis, the algorithm learns and suggests pump-setting changes~     for optimization of glucose control.~      The objective of the research project, called MD-Logic Advise4U, is to test the MD-Logic~     pump advisor in a clinical study. The study will generate data necessary to address the~     safety, reliability, and efficacy of this algorithm~   "
33609|NCT02617147|"~     The purpose of this study is to assess the influence of vitrectomy on changes in central~     choroidea and comparing the results in imaging of the choroidea with two different OCT~     devices.~      This is a prospective, open, non-randomized, observational, MPG study This study will be~     performed at the Department of Ophthalmology, Medical University of Vienna.~      40 Patients who undergo vitrectomy will be included into this study. The investigation will~     help to gain new information about the effects of vitrectomy on the choroid.~   "
33610|NCT02617134|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.~   "
33611|NCT02617121|"~     This study was designed to compare the effects of gabapentin and ramosetron on PONV in~     patients undergoing laparoscopic gynecologic surgery.~   "
33612|NCT02617108|"~     Patients who want to go TCRS will randomly divided 2 groups. In Group 1 (100 patients), a~     Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed~     into the uterine cavity at the end of the operation for five days. In Group 2 (110~     patients), women will not receive any of the treatment (comparison group). All subjects~     underwent two further hysteroscopy, one and three months after the initial surgery. At the~     second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.~   "
33613|NCT02617095|"~     The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in~     the treatment of moderate to severe Dry Eye Syndrome.~   "
33616|NCT02617056|"~     It is generally acknowledged that patients with dementia are best cared for at home.~     However, outbursts of various behavioral disturbances, e.g., combativeness, appear in most~     cases and often necessitate institutionalization. These outbursts are often without apparent~     warning, which limits preventive interventions. The measurement of the electrical activity~     of the skin is well-studied as an indicator of stress or agitation. The investigators~     propose to monitor the electrical activity of skin in patients with dementia in order to~     determine whether any sign of agitation may occur before the outburst. If skin electrical~     activity gives sufficient warning, then preventive interventions may be tried. If~     successful, the ability to predict and prevent outbursts of behavioral disturbances will~     allow patients to be cared for at home for longer periods. It is the primary aim of this~     project to determine whether skin electrical activity gives such a warning; possible~     preventive measures will be the subject of future studies.~   "
33617|NCT02617043|"~     The study was designed to evaluate the feasibility and safety of hypofractionated~     whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer~     after breast conserving surgery in Chinese population.~   "
33618|NCT02617030|"~     Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP:~     qualitative survey. Interviews with carers, young people and parents. Chronic Diseases~     studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey.~     Vote on internet : carers, patients' associations, young people and family. Chronic Diseases~     studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic~     Diseases studied: all.~   "
33619|NCT02617017|"~     Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher~     prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor~     complications that impair quality of life for patients with PD. The mechanisms of these~     dyskinesias remain unclear, but several hypotheses have been put forward: non continuous,~     pulsatile stimulation of dopaminergic receptors, or alterations of other neurotransmitters~     within the motor striatum such as glutamate and serotonin.~      Few strategies are now available to treat severe LID:~        -  Medications: reduction of dopaminergic treatment, addition of amantadine,~        -  Functional neurosurgery. The purpose of this study is to investigate the efficacy of~          buspirone in PD patients suffering from dyskinesias. The role of serotonin in the~          occurrence of LID was recently demonstrated in transplant PD patients and a test~          double-blind, single dose was achieved. Following administration of 10 mg oral~          buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of~          buspirone had already been reported in 1991 and 1994, but identification of buspirone~          as a serotonin receptor agonist has been reported more recently.~      This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa~     induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial,~     the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible~     dose/effect relationship and (4) check the hypothesis of a better therapeutic ratio using~     the association of buspirone and amantadine instead than a single drug.~   "
33620|NCT02617004|"~     The purpose of this study is to prospectively validate the new risk model, based on minimal~     residual disease (MRD) response level and oncogenetic status by comparing historical results~     of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients~     (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).~   "
33621|NCT02616991|"~     The purpose of this study is to determine whether systematically performing computed~     tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs,~     during the venous phase of opacification) in addition to thoracic CT angiography in women~     with suspected postpartum pulmonary embolism (PE) results in a gain in venous~     thromboembolism detection rate.~   "
33622|NCT02616978|"~     This is an Internet survey to collect data on the use of the Cefaly device to treat migraine~     attacks in regular Cefaly users.~   "
33623|NCT02616965|"~     This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab~     Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.~   "
33624|NCT02616952|"~     The purpose of this study is to determine whether Yiqi Suoquan Tang, a Chinese Herbal~     decoction, is effective in the treatment of female stress urinary incontinence.~   "
33625|NCT02616939|"~     Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.~   "
33626|NCT02616926|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients~     with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been~     recommended as the standard therapy in many clinical practice guidelines. The combination of~     TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment.~     However, more and more retrospective studies have reported better therapeutic efficacy of~     hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare~     the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC~     through prospective randomized clinical trial.~   "
33627|NCT02616913|"~     This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001,~     R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)~     exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo,~     and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.~   "
33628|NCT02616900|"~     The eSight Quality of Life and Efficacy Study (eQUEST) is a prospective cohort study~     intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided~     by eSight Eyewear to persons with significant visual impairment resulting from various eye~     conditions. The multi-site study will evaluate the efficacy of the eSight device for various~     Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.~   "
33629|NCT02616887|"~     Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid~     tumors, investigators have designed this study to assess feasibility of SBRT in selected~     patients with spine metastases.~   "
33630|NCT02616874|"~     The BCN02-Romi study aims to evaluate a combined kick and kill strategy using the most~     immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency~     reversal agent available at present time (romidepsin) in a cohort of early-treated HIV~     positive individuals.~   "
38245|NCT02556463|"~     To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid~     tumor cancers.~   "
33631|NCT02616861|"~     Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and~     pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy~     volunteers, in fed and fasted states, in a single-dose crossover study.~      Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses~     of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple~     ascending-dose study with optional up-titration of dose level within cohort.~   "
33632|NCT02616848|"~     Treatment of triple negative breast cancer (TNBC) relies heavily on different regimes of~     chemotherapeutic agents but remains one of the most challenging subtypes to treat because of~     the lack of specific therapies. Despite being sensitive to chemotherapy, many women with~     TNBC relapse quickly, developing locoregional recurrence or visceral metastasis. Toxicity~     and chemotherapy resistance are still major limitations in the treatment of patients with~     TNBC. Despite current trend of targeted therapy development, cytotoxic agents are a mainstay~     of treatment of patients with breast cancer. Further research into new combination of~     different compounds is needed in order to maximise benefit, whilst minimising toxicity.~      The phosphoinositide 3-kinase (PI3K) pathway is associated with resistance to a variety of~     anti-tumor agents. This has been described pre-clinically with cytotoxic chemotherapeutic~     agents with varying mechanisms of action including taxanes, and DNA-damaging agents. In the~     clinic, activated PI3K in tumors has been correlated with decreased response to therapy and~     worse clinical outcomes.~      The recent biological findings suggest that a PI3K/mammalian target of rapamycin (mTOR)~     inhibitors may increase the efficacy of chemotherapeutic agents which are considered~     standard of care (SOC) for the treatment of several solid tumors.~      The study by the Unitaed state Oncology Research of Huston and the Sarah Cannon Cancer~     Center randomized 1830 patients with high risk breast cancer to the standard adjuvant~     treatment with adriamicin cyclophosphamide followed by paclitaxel versus the experimental~     adjuvant treatment with adriamicin taxotere (AT) followed by paclitaxel. At 5-years of~     follow up, the AT followed by paclitaxel produced significantly better overall survival~     (p=0.054) and improved disease free survival (DFS) (p=0.19). Among TNBC patients both DFS~     (74% versus 79%, p=0.1) and overall survival (OS) (79% versus 84%, p=0.037) were better in~     experimental arm. However, the main reasons for patients being taken off study treatment~     were toxicity (85 patients in the control arm and 128 in the experimental arm) and consent~     withdrawal (18 patients in the control arm and 30 patients in the experimental arm). For~     this reason, research into alternatives has intensified, thus resulting in the discovery and~     development of new compounds with a more tolerable profile as compared with paclitaxel.~      Among the total of 762 patients enrolled into Eisai Metastatic Breast Cancer Study Assessing~     Physician's Choice Versus E7389 (EMBRACE) trial, 19% had TNBC. Of note, eribulin was most~     effective in hormone receptor-negative patients and in TNBC patients, who had a 29% risk~     reduction. Treatment with eribulin was well tolerated. Neutropenia, leucopenia, peripheral~     neuropathy, and asthenia/fatigue were the most common adverse events reported at Common~     Terminology Criteria for Adverse Events (CTCAE) grades 3 and 4. Neutropenia was the most~     common adverse events reported at CTCAE grade 4 in the eribulin group (24.1%).~      Based on findings to date, eribulin is an attractive agent, and its role in combination with~     new compounds such as everolimus deserves further investigations. Their combination might~     lead to more profound effects on tumor cell biology of triple negative metastatic breast~     cancer.~      During the course of the trial, dose reductions for each combination will be permitted in~     patients who cannot tolerate the starting dose~   "
33633|NCT02616835|"~     This research seeks to study the physiological effects of theta-burst transcranial magnetic~     stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.~   "
33634|NCT02616822|"~     Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a~     major modifiable risk factors and one of the most important public health problems.~     Mortality from cardiovascular disease increases progressively with increasing blood pressure~     (BP) in a linear, continuous and independent. The pathophysiological mechanisms involved in~     the pathogenesis of hypertension exhibit metabolic abnormalities, which are related to~     endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of~     plants, but in our food, mainly present in red wine and grapes, has shown protective effects~     in cardiovascular diseases, such as preventing the damage caused by oxidative stress,~     decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective~     effect of vascular endothelium, with increased release of nitric oxide and decreased~     production of free radicals in animal models, but human studies are limited and insufficient~     to clarify the possible effects of trans-resveratrol (biologically active form) on~     endothelial function, blood pressure and central aortic pressure in treated hypertensive~     individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol~     supplementation on endothelial function in treated hypertensive patients.~   "
33635|NCT02616809|"~     This study aims to test the short-term effects of intermittent standing, slow cycling and~     slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure~     among pre-hypertensive and pre-diabetic adults.~   "
33636|NCT02616796|"~     The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving~     social gaze behavior in children with fragile X syndrome (FXS). The investigators will use~     the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills.~     Importantly, the investigators propose to examine the effects of this treatment probe on~     brain and behavior.~   "
33637|NCT02616783|"~     This study will evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir~     alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by~     assessing spine and hip bone mineral density (BMD) measured at Week 48 in~     virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.~   "
33638|NCT02616770|"~     To evaluate the safety and tolerability of S-1226 composed of perflubron with ascending~     doses of carbon dioxide (4%, 8%, and 12% CO2) administered over 2 minute nebulisation to~     healthy subjects.~   "
33639|NCT02616757|"~     Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone~     lesions. Literature to date describes little agreement between clinicians on specific~     prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has~     shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given~     its association with the mechanical properties of bone. There has been further exploration~     into the use of quantitative ultrasound to assess bone density by measuring the velocity of~     the ultrasound transmission over the bone. To determine whether the QUS can provide~     prognostic information with respect to cyst healing, recurrence or fracture with a SBC,~     further study is needed.~   "
33640|NCT02616744|"~     A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of~     oral bisphosphonate treatment on bone mineral density in osteopenic women receiving~     aromatase inhibitors as adjuvant treatment.~   "
33641|NCT02616731|"~     To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in~     women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.~   "
33642|NCT02616718|"~     This is a prospective multicenter study of patients diagnosed with a medium to giant~     incisional hernia (transverse defect >7 cm). Patients referred to the surgical outpatient~     clinic are invited to participate in the study. As a standard, all patients who are examined~     for incisional hernia undergo CT scan according to a hernia protocol, before planning of~     surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient~     clinic once again and either treated conservatively without surgery, or scheduled for~     elective surgical repair of the hernia.~      If surgery is planned, the patients participating in the study undergo an additional CT scan~     in hernia protocol, within two weeks prior to surgery (follow-up scan).~      If a conservative non-surgical approach is chosen, patients can still participate in the~     study and will undergo an additional CT scan after 28-32 weeks.~   "
33643|NCT02616705|"~     Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may~     affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis~     (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or~     cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity~     of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of~     various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical~     cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4~     concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.~   "
33644|NCT02616692|"~     This non-interventional cross-sectional online survey will evaluate preferences among~     patients with self-reported HCC. The survey will ask patients to express their preferences~     regarding descriptions of HCC treatments, which will include sorafenib (which will be~     described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE),~     and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that~     patients may have received before completing this online survey were given regardless of~     their participation in this survey. Questions also include asking patients to rank various~     treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.)~     relative to each other. The ultimate goal is to better understand patient perceptions of~     these treatments and to provide evidence to help in patients' and physicians' treatment~     decision-making in HCC.~   "
33645|NCT02616679|"~     The current study aims to validate several novel cognitive tasks expected to be sensitive to~     brain impairment in specific anatomic regions affected in preclinical Alzheimer's~     disease(pAD). The tasks are validated in 60 cognitively and clinically normal participants~     ages 60 - 85, inclusive, against reasonably well-established biomarkers of Alzheimer's~     disease, including 1) simultaneous positron emission tomography (PET) [18F]Flutemetamol~     amyloid and CT imaging and 2) to the extent data is available from other studies,~     participants' brain MRI and cerebral spinal fluid (CSF) amyloid and tau.~   "
33646|NCT02616666|"~     A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness~     between dapagliflozin and Standard of Care (SOC).~   "
33647|NCT02616653|"~     This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar~     levels or more) when the palpation method is used in obese parturients at term in the~     lateral position compared to the sitting position.~      Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two~     levels higher than the level determined by ultrasonography (US) more often in the lateral~     than in the sitting position.~   "
33648|NCT02616640|"~     This is a multicenter, multicountry, open-label, Phase 1b study for dose finding as well as~     parallel cohort dose expansion(s) to determine the recommended dose and regimen of~     durvalumab either as monotherapy or in combination with pomalidomide (POM) with or without~     low dose dex in subjects with Relapsed and Refractory Multiple Myeloma (RRMM). The study~     will consist of a dose-finding portion as well as a parallel dose expansion portion to~     determine the optimal dose and regimen.~   "
33649|NCT02616627|"~     Aims:~        1. To determine whether BMD and muscle mass were associated with fractures and other~          adverse events in dialysis patients.~        2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and~          vitamin D on low bone mineral density and sacropenia in dialysis patients.~      Method:~      In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone~     microstructure parameters, and body composition in chronic dialysis patients. Also, the~     investigators plan to use blood testing to measure the blood level of FGF23, calcium,~     phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program~     for these participants to evaluate clinical courses and outcomes. Patients will receive DXA~     (including BMD and body composition) tests and blood work at baseline and one-year. Muscle~     power and physical performance will be measured at baseline, 6 months and one-year.~   "
33650|NCT02616614|"~     Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75%~     gel. This study is designed to evaluate the safety and efficacy of this formulation in~     subjects with Acne Vulgaris~   "
33651|NCT02616601|"~     This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil~     0.5% cream against the brand product (Carac) in subjects with actinic keratoses~   "
33652|NCT02616588|"~     The overall goal of this study is to evaluate the feasibility of a veteran patient navigator~     and social work counseling intervention in veterans with advanced stage cancer at the Denver~     VA Medical Center. This is a tiered intervention: patients first receive the veteran patient~     navigator component of the intervention, and then if additional patient needs are present~     they receive the social work counseling component of the intervention. The overall~     intervention will help veterans communicate their care preferences with their providers.This~     is a study of behavioral and care strategy interventions and involves no investigational~     drugs or devices.~   "
33653|NCT02616575|"~     Aims: The purposes of this study are~        1. to create a smart living environment with home care system using GPS and cloud-based~          services for elderly people.~        2. to improve the home care system from user feedback and recommendations.~      Methods: Participants (n = 50) will be recruited from geriatric clinics in National Taiwan~     University Hospital (NTUH) main hospital and its Beihu branch. Enrollment criteria include:~     aged 60 or older, living alone or with one companion (not children), taking at least one~     chronic medications, having the capability to understand the study and complete the study,~     willing to participate into the study with telephone follow ups.~   "
33654|NCT02616562|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety~     of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment~     (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth~     hormone deficiency.~      The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension~     period and a 104 weeks safety extension trial period.~   "
33655|NCT02616549|"~     The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention~     featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major~     Depressive Disorders with incomplete response to antidepressants.~   "
33656|NCT02616536|"~     Procedures:~      The study will be conducted in two phases:~      Phase 1~        -  Perception and Satisfaction questionnaire will be developed~        -  A validation test will be conducted on the Perception and Satisfaction questionnaire~          (face, content and construct) before conducting the study. The validation process will~          involve the participation of lecturers, professors and students by convenience~          sampling.~      Phase 2~        -  To prevent bias from the researchers, each participant will be given their code as~          their identification number. Then the participants will be randomly divided into two~          groups. They will be briefed on the purpose of study (stating that, the investigators~          would like to see the efficacy of various teaching methods on students' knowledge gain)~          and procedure of the study (examinations will be conducted, surveys at the end of each~          class session and at the end of the study). They are requested to fill up basic~          demographic data, consent form and ILS questionnaire(measuring the learning style of~          student) before beginning the study.~        -  In this study, the lecture will be given by the 'Researcher 1' to standardize the input~          to the participants of the two groups. This will produce a standardized input to the~          students of the two groups of teaching method.~        -  For the FC (flipped classroom) group, the length of the pre-recorded lecture videos~          will be the same which the participants can view it unlimitedly. An assignment will be~          given for FC group that will be attempted during the discussion class(2 hours) a week~          after with the lecturer. No grades will be given for the assignment.~        -  Meanwhile for the TC(traditional classroom) group, a standard lecture class of 1 hour~          and 1 hour of tutorial class will be conducted on the same topic. The same ungraded~          assignment will also be given to this group a week after the lecture class to be~          attempted in the tutorial class~        -  One day gap will be given following the discussion and tutorial class for FC and TC~          groups respectively following which an examination of 1 hour duration will be conducted~          to test on their level of knowledge (assessed by exam score) on the topic being taught~          for both the groups using the same set of questions.~        -  At the end of the study, each participant will be given a feedback questionnaire to~          evaluate their perception and satisfaction on the teaching method applied on them using~          the 'Perception and Satisfaction Questionnaire'.~   "
33682|NCT02616198|"~     The aim of this study was to evaluate the long-term clinical performance of two highly~     viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia~     Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS)~     criteria.~      A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish~     was used randomly on the surface of the restorations. The restorations were evaluated at~     baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The~     results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p< 0.05).~   "
33657|NCT02616523|"~     Using combination of opioid analgesics and analgesics with different mechanism of action the~     investigators can decrease the consumption of opioid analgesics and their side effects. The~     investigators will use opioid analgesic fentanyl alone or in combination with~     dexmedetomidine or lidocaine.The participants scheduled for laparoscopic intestine resection~     will be divided in three groups: in the first group, the participants will receive single~     boluses of fentanyl, in the second group, the participants will receive continuous infusion~     of lidocaine and single boluses of fentanyl, and in the third group, the participants will~     receive continuous infusion of dexmedetomidine and single boluses of fentanyl. Participants~     with intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of~     fentanyl during the operation and less opioid analgesics after the operation in comparison~     to those who will receive only fentanyl boluses. Better cognitive function after the~     operation is expected in participants receiving dexmedetomidine infusion. There will be~     minimal incidence of neuropathic pain because of minimal surgical injury of peripheral~     nerves in all groups of patients.~   "
33658|NCT02616510|"~     The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of~     reproductive age. PCOS is associated with various cardiovascular risk factors such as~     obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether~     these increased cardiovascular risk factors result in the development of actual~     cardiovascular disease in later life remains to be established.~      Women with premature ovarian insufficiency (POI), experience menopause prior to the age of~     40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been~     previously associated with increased cardiovascular morbidity and mortality.~   "
33659|NCT02616497|"~     Investigation of the efficacy and safety of triflusal in comparison with aspirin in patients~     with stable coronary artery disease (CAD) and in those with a history of an acute~     non-cardioembolic ischemic stroke.~   "
33660|NCT02616484|"~     The objective of this research study is to conduct a pivotal phase 3 trial of treatment with~     the investigational drug dichloroacetate (DCA) in young children with deficiency of the~     pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of~     congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for~     which no proven treatment exists. The investigators predict that DCA represents targeted~     potential therapy for PDCD because of its ability to increase both the catalytic activity~     and stability of the enzyme complex. The conclusions of numerous laboratory and clinical~     investigations are consistent with this postulate and have led to the designation of DCA as~     an Orphan Product for congenital lactic acidosis by the Food and Drug Administration.~      Because PDCD is a rare disease and the life expectancy of most affected children is severely~     truncated, the pool of participants available to participate in clinical trials is limited.~     To overcome this potential barrier the following actions will take place for recruitment: 1)~     contact a network of clinical investigators across North America who are experienced in the~     evaluation and care of PDCD patients; 2) contact an international parent organization of~     affected children; 3) contact a recruitment disease-targeted resource to disseminate~     information about the trial to clinicians and affected families; and 4) incorporated novel~     study design and treatment outcome measures to optimize the probative value from small~     sample sizes for this trial.~   "
33661|NCT02616471|"~     The overall aim of the present research project is to examine whether consumption of high~     daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a~     study population of men and women with metabolic syndrome risk factors.~      It will be explored whether high-fat and/or low-fat cheese consumption can be regarded~     healthy to consume for at-risk populations (assessed by within-group comparisons from~     baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue~     to be recommended (assessed by between-group comparisons).~      In addition, it will be assessed if cheese consumption affects women and men differently as~     suggested by observational data. The present research project will examine the health~     effects of cheese as a food product per se and not as a sum of single nutrients, knowing~     that the single components of cheese cannot be adequately placebo-matched. A relatively high~     daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and~     with a carbohydrate control.~   "
33662|NCT02616458|"~     Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a~     program of anticipatory guidance counseling for ear pain at the 12-15 month routine~     preventive care visit in a predominantly low income population can reduce medical visits to~     clinic, emergency department (ED), and urgent care (UC).~      Design: Single blind randomized control trial of an ear pain counseling program.~      Setting: The Child Health Clinic (CHC), a primary care clinic at Children's Hospital~     Colorado, which serves a predominantly low income population with diverse cultural and~     ethnic backgrounds.~      Participants: 310 mothers were enrolled at their child's 12-15 month well child visit.~      Intervention: Structured 10-minute education intervention, given by a research assistant,~     used a slide presentation that reviewed ear pain Main Outcome and Measures: Number of ED,~     UC, and clinic visits for otitis media for the 12 month period after entry into the study~     and whether the visit included a prescription for antibiotics.~   "
33663|NCT02616445|"~     The purpose of this study is to determine whether the drug UE2343, a potential treatment for~     Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics~     and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study~     will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.~   "
33664|NCT02616432|"~     A randomized screening trial to compare the diagnostic accuracy of screening for breast~     cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional~     full-field digital mammography (FFDM) versus FFDM alone.~   "
33683|NCT02616185|"~     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing~     doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.~   "
33684|NCT02616172|"~     Autologous human bone marrow mononuclear fraction (BMMF) will be harvested and given to~     children with bilateral moderate to severe sensorineural hearing loss. The aim is to~     determine if bone marrow mononuclear fraction (BMMF) infusion is safe, feasible, improves~     inner ear function, audition, and language development.~   "
33685|NCT02616159|"~     The objectives of this study are to compare the glycemic and insulinemic responses over 3~     hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat~     and hot cereals.~   "
33665|NCT02616419|"~     Since the late 1980s, several studies focused on pediatric procedural pain and show that it~     still underevaluated and undertreated, especially in the Emergency Department (ED).~     Needle-related procedures are the most important source of pain and anxiety and children.~     Since it is impossible to completely eliminate the pain and anxiety experienced by children~     during painful procedures, use of non-pharmacological and/or pharmacological interventions~     might be beneficial. Most methods used for relief of procedural pain and anxiety for~     children require time or extra staff, which represent barriers to their implantation in the~     ED. An easy-to-use and rapid non-pharmacological intervention could overcome these~     constraints and optimize procedural pain and anxiety relief in children undergoing a~     needle-related procedure.~      The purpose of this study is to determine the efficacy of a new device (Buzzy®) combining~     the effect of cold and vibration for the procedural pain and anxiety relief in children~     undergoing needle-related procedures in the ED. The investigators will compare the use of~     Buzzy® to an anaesthetic cream (Maxilene®) for pain intensity and anxiety level of children~     undergoing a needle-related procedure (venipuncture, IV access). They will also asses~     satisfaction of the Buzzy® device with nursing personnel, children (when possible) and~     parents. Success at the first attempt of the painful procedure and memory of pain will also~     be documented.~      Investigators strongly believe that the use of the Buzzy® device in the ED will improve~     significantly the pain and anxiety felt by children undergoing needle-related procedures.~     Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological~     intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful~     tool for procedural pain. Given this knowledge, the investigators feel that this randomized~     controlled trial will have the potential to improve nursing practice and optimize painful~     and anxiety experiences of children undergoing needle-related procedures.~   "
33666|NCT02616406|"~     This is a study using wearable monitoring devices, patient activity and sleep patterns to~     monitor pre and post operative following outpatient inguinal hernia surgery to determine~     when these parameters return to baseline.~   "
33667|NCT02616393|"~     A study to assess the activity of tesevatinib in subjects with NSCLC and activating EGFR~     mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal~     Metastases (LM) or who heave either BM or LM at initial presentation.~   "
33668|NCT02616380|"~     The study is designed as a prospective, observational study to assess the effect of~     adalimumab on health-related quality of life (QoL) and work productivity in patients with~     rheumatoid arthritis (RA) in Taiwan.~   "
33669|NCT02616367|"~     This is a randomized prospective outcomes study comparing two groups of patients. One group~     will receive liposomal bupivacaine for a periarticular injection. The other will receive~     ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the~     primary objective of this study is to determine if liposomal bupivacaine provides superior~     pain control (decreased maximal pain scores within the first 72 hours post surgery) when~     compared to ropivacaine when injected in a periarticular injection.~   "
33670|NCT02616354|"~     Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with~     severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for~     clinical rational use of antimicrobial agents, and provide theoretical support for~     optimizing dosage regimen.~   "
33671|NCT02616341|"~     The overall aim of this study is to determine modifications to Exposure and Response~     Prevention (ERP) therapy that are needed in order to effectively deliver treatment for~     Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the~     final study in a series of three projects executed to adapt and pilot-test a team ERP~     (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to~     assist with group-ERP treatment plans. The intervention will be tailored to meet the unique~     needs of low-SES individuals with OCD and be implemented in a community mental health center~     (CMHC).~   "
33672|NCT02616328|"~     This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy~     and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical~     practice.~   "
33673|NCT02616315|"~     The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and~     bupropion hydrochloride extended release combination (NB) compared with placebo on weight~     loss in obese participants post bariatric surgery.~   "
33674|NCT02616302|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily (QD) oral administration of dexlansoprazole capsules (15, 30, and 60 mg) in pediatric~     participants aged 1 to 11 years with symptomatic nonerosive gastroesophageal reflux disease~     (GERD).~   "
33675|NCT02616289|"~     The investigators hypothesize that the absorption of topically applied EFA-containing~     emollient (SSO) into the skin and thence into the bloodstream in children with SAM will~     improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond~     that possible through normal standard-of-care~   "
33676|NCT02616276|"~     This is a crossover clinical trial aimed at adults (aged 20-40 years, with no cardiovascular~     disease), selected by consecutive sampling at urban primary care health clinics in Salamanca~     (Spain). Each subject will complete three interventions, with a washout period of one week:~     control breakfast (water), low glycemic index breakfast (apple, yogurt, walnuts and black~     chocolate) and high glycemic index breakfast (grape juice, bread and strawberry jam). The~     postprandial effect will be assessed at 60 and 120 minutes from each breakfast, measuring~     blood glucose and insulin and cognitive performance. Measurements will be performed of~     central blood pressure, augmentation index, pulse wave velocity, cardiac output and total~     peripheral vascular resistance at minutes (-10, 0, +15, +30, +45, +60, +75, +90, +105 and~     +120).~   "
33677|NCT02616263|"~     The purpose of this research study is to determine the relationships between foot muscle,~     foot motion, and toe deformity. Results from this investigation will help the investigators~     to understand what contributes to foot deformities and the role of the foot muscles in the~     development of foot deformities. This could potentially guide treatment options focusing on~     strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.~   "
33678|NCT02616250|"~     The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM)~     associated with Brimonidine 0.33% gel (Br) compared with the association of their respective~     vehicles in the treatment of moderate to severe rosacea.~   "
33679|NCT02616237|"~     The purpose of this study is to determine the feasibility and efficacy of a 6-month weight~     loss intervention program for obese working adults through a popular social networking site~     - Facebook.~   "
33680|NCT02616224|"~     This observational disease registry is a prospective, national, non-interventional study~     designed to enroll participants who have received an initial diagnosis of unresectable,~     locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry~     enrolment. These participants will be prospectively followed for at least 5 years after~     study enrolment to evaluate their anti-cancer treatments. Data on participants' previous~     anti-cancer treatments for breast cancer will be collected retrospectively at study entry.~   "
33686|NCT02616146|"~     The purpose of this study is to assess the contraceptive efficacy of the ENG-E2 vaginal ring~     in women between 18 and 35 years of age based on the number of in-treatment pregnancies as~     expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of~     ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral~     contraceptive (COC) will be used as the active comparator.~   "
33687|NCT02616133|"~     Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated~     by a medical oncologist for neo-adjuvant treatment due to the current lack of care~     coordination between the surgeon/surgical oncologist and the medical oncologists.~      This project will evaluate the feasibility to enhance knowledge that drives adoption of~     evidence based care, and evaluate the improvement in care coordination between oncologists~     and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.~   "
33688|NCT02616120|"~     The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on~     non-motor symptoms of PD patients.~   "
33689|NCT02616107|"~     The purpose of this two-year mixed methods study is to develop and test an intervention to~     improve cancer family caregivers' knowledge of care options (curative, palliative, and~     hospice care) and goals of care communication as part of a self-management (SM) training~     program.~      The two specific aims of this project are to:~        1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's~          Guide (MCC-CG), for family caregivers of patients with breast cancer to increase~          knowledge of care options, goals of care communication, and other SM skills.~        2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized~          controlled trial compared with an attention-control condition (symptom management~          education) on knowledge of care options, goals of care communication, and other key SM~          skills (engagement in SM, management of transitions and uncertainty, increasing~          self-efficacy, appropriate use of health care resources).~   "
33690|NCT02616094|"~     Extending previous findings, and applying a novel multi-method translational approach, this~     project hypothesizes that there are alcohol-related neuroendocrine and neural changes~     observable in acute and protracted abstinence, and which can accurately classify future~     relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby~     validating them as biomarkers of relapse, with potential clinical utility as prognostic~     markers in identifying and treating those most susceptible to relapse.~   "
33691|NCT02616081|"~     The investigators goal is to create a better understanding of patient reported outcomes for~     bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter~     (IDC) and bladder surgery.~   "
33692|NCT02616068|"~     This study evaluates the non-inferiority of the new transdermal patch dosage form containing~     loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet -~     Daiichi-Sankyo) for the treatment of acute traumatic injuries.~   "
33693|NCT02616055|"~     Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment~     will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101~     study.~   "
33694|NCT02616042|"~     This study aims to evaluate the effect of dentifrice formulations containing Centella~     asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which~     contains Centella asiatica and bamboo salt and the same participants will also use placebo~     for tooth brushing by cross-over design.~   "
33695|NCT02616029|"~     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen~     consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine~     (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived~     nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V~     and/or M184I in HIV-1 reverse transcriptase.~   "
33696|NCT02616016|"~     The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity~     and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No~     serious adverse effects are expected to result from this treatment.~   "
33697|NCT02616003|"~     The frequency of patients with a BMI above 70 kg/m2 who need immediate weight loss surgery~     is risen continuously. For those patients a prior-to-surgery conditioning therapy is~     mandatory to gain technical and physical operability. The exclusively well-established~     preliminary therapy so far was the intragastric balloon, which takes 7 months of treatment~     time. Due to life-threatening conditions of giant obese patients, who have been admitted to~     hospital, the investigators were forced to develop a more prompt acting conditioning therapy~     to bring those individuals in a short run to an improved and fit-for-surgery state. In~     such an impasse the investigators combine Liraglutide with its well-known weight-loss effect~     with a leucine-based amino acid infusion that is generally used for patients with liver~     insufficiency, in expectance of an additional weight loss and liver reduction effect.~   "
33698|NCT02615990|"~     This study will assess the effects of the Erigo applied as part of the early mobilization~     program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the~     Erigo, critically ill patients will tolerate verticalization and mobilization earlier and~     safely resulting in improved outcomes measured by increased mobility and strength on ICU~     discharge, decreased requirements for mechanical ventilation, reduced complication rates and~     decreased ICU and hospital LOS.~   "
33709|NCT02615847|"~     Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary~     hemolytic anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are~     hallmarks of this disease and are causative for an important socio-economic burden~     worldwide, especially in Africa.~      Aside from allogenic stem cell transplantation, which is rarely available and very~     expensive, at present there is no curative treatment for patients with sickle cell disease~     (SCD). The current standard of care includes treatment with hydroxycarbamide and symptomatic~     care such as transfusions, antibiotic/analgesic treatment.~      This study has the aim to study the safety and tolerability of Memantin in patients with~     sickle cell disease.~   "
33721|NCT02615691|"~     The purpose of this study is to investigate safety, immunogenicity and hemostatic efficacy~     of PEGylated recombinant FVIII (BAX 855) in previously untreated (PUPs) and minimally~     treated patients (MTPs) with ≤ 3 EDs to ADVATE or BAX 855 < 6 years of age with severe~     hemophilia A (baseline FVIII level < 1%)~   "
33699|NCT02615977|"~     The investigators will examine clinical alterations in learning and automated approach~     behaviour and their neurobiological correlates in alcohol-dependent patients and healthy~     social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT;~     randomized verum versus placebo training) which trains subjects to habitually push~     alcohol pictures away.~      The investigators will test whether activations following treatment predict relapse rate~     (primary outcome measure) and the prospective amount of alcohol intake (secondary outcome~     measure) within a six-month follow-up period.~      Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm~     established during the first funding period to distinguish the effects of appetitive,~     aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and~     to assess ZJT training effects comparing functional activation before and after ZJT~     training.~      The investigators will also scan subjects during performance of a short standard working~     memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based~     Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its~     effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).~   "
33700|NCT02615964|"~     Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will~     be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma~     will be studied. This research study is being done to better understand Raynaud's disease~     and to assess the role of blood flow measurement in diagnosing the disorder, specifically,~     through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow~     measurement software system owned by the study's sponsor, VasSol, Inc.~   "
33701|NCT02615951|"~     Recently, it has been shown that B cells could also have regulatory functions through the~     secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the~     mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis~     (CIA), the transfer Breg helps prevent the development of CIA and cure established~     arthritis. The investigators have recently shown that Breg were decreased in patients with~     RA compared to controls and that the rate of Breg was inversely correlated with disease~     activity and autoantibody. These results thus suggest that the lack of IL-10 secretion by B~     cells plays an important role in the pathophysiology of RA. Nevertheless, in humans, the~     Breg remain poorly understood. The main objective of this project is to better characterize~     the B capable of producing IL-10 both in subjects with RA and controls. Understanding which~     induces the secretion of IL-10 by B could allow to consider new therapeutic approaches in~     autoimmune diseases, including in RA.~      The investigators therefore aim to identify nutrient transporters, chemokine receptors,~     genes and surface proteins differentially expressed between Breg and other B cells in~     patients with RA and in controls.~   "
33702|NCT02615938|"~     This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled,~     parallel-group, multinational study investigating the initiation or withdrawal of~     hydroxychloroquine in subjects with chILD.~   "
33703|NCT02615925|"~     Provide a description of patients admitted in the psychaitric department of the Mayotte~     Hospital~   "
33704|NCT02615912|"~     The purpose of this study is to understand the changes in skin microflora, skin barrier~     function, and skin biochemical constituents in response to direct contact with model~     surfactants used in personal care articles. The results from this study will provide~     insights into the complex interaction between the skin microbiome and the epidermis after~     exposure to surfactants.~   "
33705|NCT02615899|"~     Background Balance impairment is a key factor contributing to falls in older adults.~     Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments~     can be identified. Objective Our objective was to use a model of balance subsystems to~     identify balance impairments and demonstrate the effectiveness of targeted (matched)~     exercises to improve balance and reduce fall risk in community-dwelling older adults. The~     investigators used the Balance Evaluation System Test (BESTest) as the model because it~     categorizes balance into 6 subsystems. Design Randomized, partially blinded,~     pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between~     impairment-matched exercises and a control, and 2. A comparison between impairment-matched~     and mismatched exercises. Setting Senior independent living community. Participants Adult~     volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria.~     Participants (n = 20) identified with impairment in the biomechanical (BC) constraints~     subsystem and participants (n = 20) with impairment in anticipatory postural adjustment~     (APA) subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed~     mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched~     subgroup received a 6-week exercise program matched to their impaired subsystem while the~     mismatched subgroup served as control. Phase 2: Following the delay, participants in the~     mismatched group received a 6-week exercise program mismatched to their impairment.~     Measurements Primary outcome variables were scores on the targeted subsystem (BC, APA),~     BESTest total, Berg Balance Scale, and fear of falling measure. Quality of life was a~     secondary outcome. Outcome data were collected by the tester blind to pretest scores and~     group allocation. Results The matched exercise subgroups demonstrated both statistical and~     clinical improvement in all outcome variables compared to the control; and showed greater~     improvement in balance impairments compared to the mismatched subgroup, but not in fall risk~     reduction. Limitations The therapist who administered the pretest knew the subgroup~     assignment and implemented the exercises. Conclusions Results provide preliminary evidence~     that using a balance assessment model to identify impairments in the BC and APA subsystems~     and prescribing targeted exercises reduces these balance impairments for older adults and~     may warrant future studies.~   "
33706|NCT02615886|"~     The purpose is to assess feasibility of rice bran consumption in weaning children and~     collect pilot data on gut microbiome and metabolome modulation with rice bran intake for~     diarrheal prevention.~   "
33707|NCT02615873|"~     The purpose of this study is to allow evaluation of long-term clinical effect and safety~     outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended~     treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core~     study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind,~     double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD~     versus IR CD/LD in fluctuating PD patients).~   "
33708|NCT02615860|"~     Comparative evaluation of efficacy and safety of high-resolution anoscopy (HRA)-guided~     topical treatment (trichloroacetic acid, TCA) vs. surgical treatment (electrocautery, ECA)~     in HIV-positive patients for human papillomavirus (HPV)- induced AIN, an anal cancer~     precursor. The primary hypothesis is that cost-saving and simple TCA treatment is~     non-inferior to the current best option therapy with ECA. TCA treatment would also be~     possible in the normal setting of a doctor´s office without extensive specialization and~     without complex technical equipment.~   "
33720|NCT02615704|"~     An electronic device application (APP) Mein Herz und ich has been developed specifically~     for acute coronary syndrome (ACS) patients who are prescribed to Brilique (ticagrelor) to~     increase adherence to treatment (medication and lifestyle changes) by a combination of~     reminders on medication intake, information on the importance of treatment, motivation by~     supportive messages, and visualisation of individual lifestyle choices' effect on~     cardiovascular risk. The aim of this study is to evaluate the effectiveness of this patient~     support tool.~   "
33710|NCT02615834|"~     We previously showed that a gentle chest pressure technique could be used on children over a~     year old to generate around 20% of the volume of air inhaled or exhaled in a single normal~     breath (also known as tidal volume). This showed that a non-invasive method could be used to~     provide a temporary means of artificial breathing, meaning that invasive procedures, such as~     putting in a breathing tube, could be avoided. What our results did not tell us, however, is~     how much oxygen can get to peripheral tissues (e.g., arms, legs) with this method. In this~     study, we want to compare two groups of children. All children will have a breathing tube;~     one group will have gentle chest pressure performed on them to see if oxygen saturations can~     be maintained above 90%. The other group will receive no chest pressure. We will see how~     long it takes for oxygen levels in both groups to drop to 90%, at which point, the patient~     will be ventilated mechanically.~   "
33711|NCT02615821|"~     Given the numerous physical and psychological benefits of engaging in regular physical~     activity (Biddle & Ekkekakis, 2005; Warburton et al., 2007) and the decrease in students'~     physical activity levels during the transition from high school to university (Bray & Born,~     2010) it is important for researchers to develop time-and-cost-effective interventions to~     prevent this drop in physical activity. Intervention research shows mental contrasting (a~     goal setting strategy) can be taught in a cost-and-time-effective way in order to increase~     physical activity (Oettingen, 2012). Researchers have also found that individuals who~     consider the emotional effects of physical activity are more likely to be physically active~     than those who consider the health-related effects (Rhodes et al., 2009). The purpose of~     this research is to combine these two approaches to develop and evaluate a novel mental~     contrasting intervention to increase physical activity among a sample of undergraduate~     students.~   "
33712|NCT02615808|"~     Hospitalized children with respiratory disease are commonly monitored with continuous pulse~     oximetry and heart rate-respiratory rate monitors. These data streams generate >4,000 unique~     data points each patient-day, yet only a tiny fraction are used to inform care decisions.~     Failure to adequately summarize this large amount of data for clinicians may result in~     suboptimal care because clinicians may miss important data signals and may under- or~     over-react to individual data points. In children hospitalized with respiratory disease and~     in need of supplemental oxygen, there are a number of care decisions, currently made without~     adequate data, which could be informed by intelligent data visualization tools. This study~     has employed user-centered design to develop data displays that inform nurses' and~     respiratory therapists' decision-making in supplemental oxygen delivery. The investigators~     are now evaluating the effectiveness of these displays in the clinical care of patients with~     two common respiratory conditions—infants with bronchiolitis admitted to the general~     pediatrics ward and preterm infants requiring supplemental oxygen who are cared for in the~     neonatal intensive care unit. By reducing patient's time on supplemental oxygen and~     improving time with optimal oxygen saturations, this work has the potential to lead to a~     breakthrough innovation that improves both outcomes and value.~   "
33713|NCT02615795|"~     The aim of this study is to evaluate the effect of monitoring patients with chronic~     obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or~     pneumonia. The patients are randomized to receive either standard treatment and follow up,~     or standard treatment and follow up, plus tele monitoring of key clinical parameters and~     symptoms for six months.~   "
33714|NCT02615782|"~     This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial~     to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose~     in healthy male subjects~   "
33715|NCT02615769|"~     The purpose of this study is to investigate if focused information of spirometry in the~     invitation to preventive health checks will increase the attendance compared with a standard~     invitation to preventive health checks.~   "
33716|NCT02615756|"~     In this study, we use positron emission tomography (PET) and functional magnetic resonance~     imaging (fMRI) to study brain mechanisms that contribute to physical exercise-induced~     reward. We examine whether acute physical exercise releases endogenous opioids in the brain,~     and whether it modulates brain responses to viewing appetizing foods. Unraveling these~     mechanism are instrumental from a public health perspective, given the undisputed positive~     health effects of physical exercise.~   "
33717|NCT02615743|"~     This study sets out to assess whether daily text message reminders help to enhance the~     consistency of use of controller medications following hospitalization for pediatric asthma~     patients ages 4-11 and their families. Text message reminders will be delivered to a~     subject's cell phone for those in the intervention group and electronic monitors will placed~     on the controller inhalers at the time of hospital discharge to track medication use over~     time in both the intervention and the regular care group. Families will complete surveys on~     the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of~     asthma care including asthma knowledge, medication routines, who is responsible for asthma~     care, and medication beliefs.~   "
33718|NCT02615730|"~     This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to~     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral~     GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject~     populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will~     be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose~     Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and~     the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with~     paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and~     clinical activity of the RP2D as determined in the Dose Escalation Phase.~   "
33719|NCT02615717|"~     Threat-related attentional biases have been identified as a possible precursor to the onset~     and maintenance of posttraumatic stress disorder (PTSD). As a result, protocols such as~     Attention Bias Modification (ABM) have been developed and utilized to treat these~     attentional biases in adults diagnosed with PTSD. However, to-date, ABM protocols have not~     been examined for use specifically among victims of sexual assaults. Participants are 20~     undergraduate women enrolled in a Midwest university. The efficacy of ABM in this population~     will be assessed, as will the relationship between ABM and PTSD symptom clusters and outcome~     variables such as anxiety and depression scores.~   "
33722|NCT02615678|"~     The aim of this study is to collect preliminary data on the effectiveness of acupuncture for~     the treatment of CIPN in breast cancer patients.~   "
33723|NCT02615665|"~     The long-term outcome of patients resected for colorectal liver metastases (CLM) after~     neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as~     the immune response to the tumor and to the CHT. The aim of this study was to investigate~     the impact of the pathological and immunological response in patients undergoing liver~     resection for CLM after CHT in regards to the long-term outcome.~   "
33724|NCT02615652|"~     Researchers of the three collaborating universities implement a pilot observational study in~     Gilgel Gibe Field Research Center, a health and demographic surveillance system run by the~     Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in~     young men for the development of common mental disorders and psychotic symptoms and the~     stability of distinct symptoms of mental disorders in the community. The investigators will~     explore in particular the impact of lifestyle on mental health in young men, including the~     traditional habit of chewing khat leaves, which contain amphetamine-like cathinone.~     Furthermore, the investigators want to demonstrate the reliability and validity of~     assessments performed by trained local interviewers.~   "
33725|NCT02615639|"~     The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who~     have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in~     Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific~     cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in~     CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the~     body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper~     cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB~     patients who have been on anti-HBV drugs but with poor effects, supposing to significantly~     improve anti-HBV efficacy, even to clean HBV from the patients.~   "
33726|NCT02615626|"~     The purpose of this study was to evaluate visfatin levels in different stages of periodontal~     diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin~     levels in Gingival Crevicular Fluid (GCF) and Serum.~   "
33727|NCT02615613|"~     30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food~     preferences using a questionnaire with 141 different foods. Accordingly, a high~     acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point~     hedonic scale). Two versions of the selected high palatability food will be devised by~     modifying it to yield the original high and the modified low acceptability versions. The two~     versions will differ only in palatability and will be equicaloric. Subjects who agree on the~     acceptability of the two versions of the food (11 subjects) will consume, at fasting, the~     two versions of the food in a cross over design over two sessions. Each session will include~     an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a~     spoonful, eating the whole portion and after 240 min. The quantity consumed on each session~     will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and~     postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30,~     60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be~     used for huger ratings.~   "
33728|NCT02615600|"~     Stimulation of the left and right auditory cortex with daily low-frequency transcranial~     random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic~     tinnitus.~   "
33729|NCT02615587|"~     The overall goal of this retrospective registry study is to investigate the~     burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be~     utilized to collect information on the diseases epidemiology including incidence and~     prevalence of AF and stroke as well as a stroke risk stratification of the Danish~     AF-population, the clinical and economical burden (in terms of direct and indirect cost) of~     AF and stroke to Danish patients, healthcare providers / healthcare system and society as~     well as describing treatment patterns with anticoagulant agents and their consequences in~     terms of stroke, bleeds, death and according cost in a real-life setting.~   "
33730|NCT02615574|"~     The investigators hypothesize that the treatment of metastatic colorectal cancer (mCRC)~     patients with the combination of alpha-type-1-polarized dendritic cell (αDC1) vaccines and~     tumor-selective chemokine modulation (CKM) will promote the infiltration of~     vaccination-induced CD8+ CTLs to tumor lesions and subsequently tumor regression with~     improved patient survival.~   "
33731|NCT02615561|"~     1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen~          Itch Relief Cream).~        2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially~          available cosmetic product~   "
33732|NCT02615548|"~     Physical activity is a key intervention used to reduce the healthcare costs and the negative~     consequences of Parkinson Disease (PD) by improving walking and balance and reducing the~     number of falls. However, not all exercise classes provide the same results for people with~     PD. Specific exercises designed to target the features of PD have shown greater outcomes~     than generic physical activity. The exercise principles include high-intensity (size and~     speed) movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies,~     treadmill walking, and making use of internal and external cues. Collectively these~     PD-specific exercises can be designed to be run in exercise groups. Structured exercise~     groups also include social interaction that is known to improve depression and apathy, both~     of which are features common in people with PD.~      This study will compare the effect of specific, long-term community-based exercise class on~     balance, walking, quality of life, and mood compare to self-directed exercise.~      Investigators anticipate that participants from the community-based, long-term intervention~     will show better improvements in balance and walking compare to participants that are~     self-directing their activities.~   "
33733|NCT02615535|"~     Spaulding Rehabilitation Hospital is conducting a research study evaluating the~     effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device~     designed to assist in cultivating a relaxed, attentive state of mind during meditation. The~     investigators study aims to evaluate whether such a tool could be useful in treating~     persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability,~     or dysregulated mood.~   "
33743|NCT02615496|"~     The study will be an observational, cross-sectional study of knowledge, understanding, and~     self-reported behavior among a sample of physicians and patients with recent aflibercept~     experience in a total of up to five European countries.~   "
33734|NCT02615522|"~     Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing~     the CE-mark.~      200 subjects will be recruited and followed up for up to ten years or until revision of the~     primary knee endoprosthesis, whichever occurs first. Documentation of clinical and~     radiological parameters within the clinical routine pre-operative and post-operative at 3~     and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee~     functionality, mobility and stability.~   "
33735|NCT02614456|"~     This is a phase I study of combination immunotherapy with IFN-γ and the PD-1 inhibitor~     nivolumab in patients with advanced solid tumors who have progressed on at least one prior~     systemic therapy, which may include prior immunotherapy.~   "
33736|NCT02614443|"~     The aims of this study are to test the effectiveness and acceptability of internet-delivered~     treatment for depression, anxiety and stress in university students. These data will inform~     the methods for a future randomized controlled trial.~      The trial will establish an initial estimate of the effectiveness of these online~     interventions for students in terms of within-group effect sizes associated with changes in~     depression, anxiety and stress from pre to post-intervention and follow-up. These data will~     be used to estimate the sample size for a future trial to ensure that the study is~     sufficiently powered. A conservative estimate using the 90% upper confidence limit will be~     used to inform the sample size calculation of the definitive RCT.~      Acceptability of the intervention to participants will be assessed using data on usage and~     engagement with the intervention (e.g. percentage of participants completing each module,~     average number of log ins, average time spent per session and total time spent on the~     program). These data are acquired through the online SilverCloud system. Satisfaction with~     will be assessed through the use of a post-intervention questionnaire on satisfaction with~     accessing and using an online delivery format for treatment.~   "
33737|NCT02614430|"~     The project will investigate levels of physical, psychosocial functions and inflammatory~     biomarkers in a group of patients who by self-assessment indicates a perceived risk of~     decline in work ability after hospital admittance. The patients will be randomised to an~     intervention of physical training and followed for development in functional levels compared~     with patients not receiving the intervention. The goal is to validate measures of work~     ability assessment in connection to hospital admittance. The validation will provide~     important information about the quality of rehabilitation services that many municipalities~     provides through private suppliers - and where the effect on work ability lacks~     evidence-based documentation.~      The project aims to link patient treatment to recovery and an optimal return to everyday~     life, comprising the patients work life. The frame is a multi-sectoral accepted platform for~     assessing patients' needs for care, treatment and rehabilitation, which is based on a~     professional assessment of the efficacy and quality of, varies heath care related~     deliveries. The acceptance of a multi-sectoral creates a need for accessible clinical tests~     of physical and mental functioning, combined with biomarkers to identify patients need.~      The project investigates whether it is possible to identify patients (age 18 to 60 year)~     with an increased risk of losing their ability to work after discharge from an acute~     hospitalisation. And to evaluate whether measurable effects on inflammation and functional~     levels of labour oriented training program can be identified.~   "
33738|NCT02614417|"~     Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease.~     Knowledge about SDB in adult congenital heart disease is limited.~   "
33739|NCT02614404|"~     The purpose of this study is to determine the efficacy and safety of imatinib in the~     treatment uncomplicated P. falciparum malaria.~   "
33740|NCT02614391|"~     Venipuncture is one of the painful procedures most frequently performed in children. Pain~     and distress management in children, during needle related procedures, is warranted.~      The base for pain management starts with behavioural and environmental support and~     distraction. Distraction is a cognitive strategy trying to divert the child's attention from~     a noxious stimulus. Active distraction involves the child in a different performance, e.g.~     playing, during pain procedures. Passive distraction redirects the child's attention to~     visual or auditory stimuli using toys, songs, movies or blowing bubbles.~      Blood-drawing centre is a peculiar setting in which many procedures have to be performed in~     a limited time. Patients usually arrive without a pharmacological premedication and go away~     immediately after procedure. In this context distraction is an excellent pain relief tool.~      The aim of the study is to compare the effectiveness of an active distraction (playing a~     videogame using a computer tablet) with a passive distraction technique in pain relief~     during venipuncture in a blood-drawing centre.~   "
33741|NCT02614378|"~     Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of~     migraine and compare it with a placebo effect of using the same procedure but without active~     insufflation. The insufflation will be used when the subject is experiencing an acute~     episode of migraine to determine its ability to reduce, if not to completely eliminate the~     migraine symptoms. Subjects receiving the placebo treatment will be offered the active~     treatment during the subsequent episode of migraine.~   "
33742|NCT02614365|"~     Whereas the advantageous effects of exercise-training on memory is increasingly recognized,~     the practicality and clinical usefulness of such interventions in community-dwelling older~     African Americans (AA)s Mild Cognitively Impaired (MCI) subjects, and the mechanism by which~     an effect occurs need elucidation. Because aerobic-exercise can improve emerging~     cardiovascular (CVD)-related risk factors for cognitive decline such as lipids, inflammatory~     cytokines and glucose homeostasis; the Investigators will examine training effects on these~     and related biomarkers. The imperative for this study is further underscored by the fact~     that, AAs: i) have high rates of dementia, and ii) have paucity of cross-sectional, and lack~     prospective data on the effects of exercise on cognition. To overcome barriers to~     recruitment and retention, enhance compliance with a long exercise program (3-times/week),~     and maximize the use of available resources, the Investigators will use a community-based~     approach. Therefore, the primary objectives of this study build on the Investigators'~     experience, and will compare the effects of aerobic-exercise to stretch-exercise (control)~     in community-dwelling AA MCI subjects. Following the initial 6 months active intervention,~     the aerobic-exercise group will follow a prescribed but free living 40 minutes, 3 time/week~     exercise regimen while the control group returns to usual care plus stretch-exercise for~     additional 12 months. This study will facilitate the estimation of sample size for a larger~     confirmatory study in AAs. A newly acquired direct oversight of the DC Ward-6 Senior~     Wellness Center and its infrastructures by the Howard University Division of Geriatrics will~     provide additional resources and access to the community. In addition to the Investigator's~     feasibility aims, the Investigators will determine performance on cognitive tasks using the~     Alzheimer's Disease Assessment Scale-Cognitive Sub-scale (ADAS-Cog) and Clinical Dementia~     Rating Scale (CDR) sum of boxes supplemented by tests of executive function (EF) and~     Functional Activity Questionnaire (FA) and together as ADAS-Cog-Plus; changes in brain~     volume regions of interest (ROI) with Magnetic Resonance Imaging (MRI), selected CVD and~     AD-related bio-markers.~   "
33745|NCT02615470|"~     The study's aim is to enhance current immunization activities in community pharmacies~     through targeting the two most commonly available non-seasonal vaccines in community~     pharmacies, namely pneumococcal and herpes zoster vaccination services. The study will~     compare the change in the number of pneumococcal and herpes zoster vaccinations administered~     in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month~     intervention period between intervention pharmacies and the control pharmacies.~   "
33746|NCT02615457|"~     RATIONALE:~      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely~     used in China for many years. The investigators previous study has reported that Huaier~     could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.~      PURPOSE:~      To evaluate the efficacy and safety of Huaier Granule in treating women who have triple~     negative breast cancer that has been surgically removed.~   "
33747|NCT02615444|"~     The purpose of this study is to determine whether daily consumption of soluble fibre, oat~     beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in~     terms of risk factors used to define metabolic disease.~   "
33748|NCT02615431|"~     The aim of the present study is to influence the central and obstructive sleep apnoea in~     patients with severe mitral insufficiency by an interventional MitraClip examination to~     evaluate.~   "
33749|NCT02615418|"~     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for~     treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind~     sham controlled partial crossover design and will involve 2 weekly treatments and~     evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the~     CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses~     quality of life improvement as measure by sleep quality and questioners. 3. Asses long term~     neuronal changes or lack thereof in treated and untreated subjects.~   "
33750|NCT02615405|"~     With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of~     physical illness in depression, the serotonin hypothesis seems to fail in approaching the~     etiology of depression. Based upon the evidence from epidemiological data, case-control~     studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid~     polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the~     unsolved of depression.~   "
33751|NCT02615392|"~     The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park~     Prescription'') to insufficiently active individuals. It is hypothesized that Park~     Prescription will motivate the target population to increase physical activity and thereby~     improve their physical and mental health.~   "
33752|NCT02615379|"~     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site~     infections (SSI).~   "
33753|NCT02615366|"~     Bleeding is an important consideration in breast surgeries that involve large resections of~     soft tissues in the breast. Inappropriate bleeding during or after surgery, can lead to~     uncomfortable fluid buildup in the breasts known as a hematoma or seroma, which may require~     additional procedures or reoperation. Patients may experience a great deal of discomfort and~     additional costs as a result; additional hospital time and procedures also burdens health~     care spending. Tranexamic acid (TXA) is commonly used drug in many medical settings to~     reduce excessive bleeding; however, no such drug is standard practice in breast surgery. The~     aim of this study is to determine if TXA is superior to placebo in reducing the bleeding~     complications in breast surgeries, including reduction mammaplasty, mastectomy with and~     without immediate tissue expander and implant-based reconstruction, and oncoplastic breast~     surgery. This study is a randomized, double-blind, placebo-controlled trial. Patients~     undergoing these procedures will be randomly allocated to receive either TXA or placebo.~     Patients will be placed on a drug/placebo regimen of 3 doses/day for 6 days starting on the~     day of their surgery. The primary outcome is the incidence of hematoma and/or seroma~     formation following breast surgery. Cost analysis of the intervention will also be~     performed.~   "
33754|NCT02615353|"~     Obesity and type 2 diabetes are critical public health issues in youth. This study will test~     the effects and estimate the cost-effectiveness of a culturally-grounded community-based~     lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with~     prediabetes.~   "
33755|NCT02615340|"~     The purpose of this study is to determine the feasibility of conducting a randomized~     controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult~     patients. The investigators hypothesize that melatonin, administered on a scheduled nightly~     basis during ICU admission, will be efficacious and safe for the prevention of delirium in~     critically ill adults.~   "
33756|NCT02615327|"~     Primary objective is to investigate the effect of polydextrose on postprandial glucose~     concentrations in healthy adults when added to a food product.~      Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.~   "
33757|NCT02615314|"~     The aim of this study is to analyze the clinical aspects of patients with BPPV associated~     with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if~     the clinical aspect and the therapeutic outcome is different.~   "
33758|NCT02615301|"~     The aims of this study were to investigate how intake of tailor-made salmon affected bone~     biomarkers, nutritional status, as well as body composition and bone mineral density. The~     122 healthy postmenopausal women included in this 12 weeks intervention study were~     randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1~     combinations) and one tablet group (vitamin D and Calcium).~   "
33759|NCT02615288|"~     This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at~     10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with~     Crohn's disease in remission.~   "
33760|NCT02615275|"~     The goal of this research study is to learn if mBCA, a type of scale that measures body mass~     (the amount of muscle and fat in your body) and your level of hydration can help researchers~     identify patients who are losing muscle mass during radiation therapy. This information will~     help researchers make decisions about nutritional supplementation and the placement of~     feeding tubes in patients receiving radiation therapy.~   "
33912|NCT02613182|"~     The rationale for this study is to provide additional treatment with NEOD001 for subjects~     who complete Study NEOD001-001, and to continue to evaluate long term safety and~     tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which~     will be continued in this study.~   "
33761|NCT02615262|"~     Perioperative administration of steroids has been demonstrated to reduce systemic~     inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass.~     However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis~     of the present study: intraoperative administration of dexamethasone reduces complication~     rates and improves clinical outcomes in infants undergoing repair of congenital heart~     defects under cardiopulmonary bypass.~   "
33762|NCT02615249|"~     48-hour application of metal allergen patches to test for potential allergic responses.~   "
33763|NCT02615236|"~     The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound~     immediatly after delivery to diagnose hidden perineal trauma that might affect patient's~     fecal continance~   "
33764|NCT02615223|"~     This trial is going to evaluate tumor control and quality of life in patients with prostate~     cancer treated with endocrine therapy with or without cryoablation.~   "
33765|NCT02615210|"~     The purpose of this study is to determine if cholangioscopically-directed biopsies provide a~     higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures~     when compared to standard means of sampling.~   "
33766|NCT02615197|"~     The present project has two primary aims: (1) to examine the effectiveness of a~     multi-component implementation strategy in improving adoption and adherence to the~     Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol, and (2) to evaluate the~     feasibility, acceptability, and effectiveness of the DBT PE protocol in a sample of~     individuals receiving DBT in public mental health agencies. This study uses a hybrid type 2~     effectiveness-implementation design to simultaneously test the clinical effectiveness of DBT~     + DBT PE and to evaluate an adaptive, multi-component implementation strategy. The~     effectiveness trial will use a quasi-experimental, controlled design to evaluate outcomes~     among DBT clients with PTSD who do versus do not receive the DBT PE protocol and outcomes~     will be benchmarked to those obtained in research settings.~   "
33767|NCT02615184|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily (QD) oral administration of dexlansoprazole 30 or 60 mg for 8 to 12 weeks in pediatric~     subjects aged 1 to 11 years inclusive, with erosive esophagitis (EE) and to assess the~     safety and effectiveness of dexlansoprazole 15 or 30 mg compared to placebo in maintenance~     of healed EE for 16 weeks.~   "
33768|NCT02615171|"~     The purpose of this research is to develop and test a mobile application called RELAX, which~     is designed to help with stress management during weight loss.~   "
33769|NCT02615158|"~     The hypothesis is that toddlers with parents who are randomized to a parenting intervention~     and toddlers with parents who are randomized to the maternal intervention focused on~     maternal diet and physical activity will be more likely to have weight status within normal~     and to consume a healthy diet and engage in physical activity than toddlers with parents in~     a placebo (safety) intervention.~   "
33770|NCT02615145|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Germany in a clinical~     practice patient population.~   "
33771|NCT02615132|"~     Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained~     a stroke. These deficits include difficulty to produce or understand language, motor speech~     disorders and cognitive-communication disorders. It is estimated that approximately 40% of~     stroke survivors will have communication disorders post stroke.~      In this randomized controlled study, the investigators' objective is to test the value of~     providing a mobile platform-based Speech Language Therapy (SLT) program to patients~     discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab~     services versus standard of care treatment. The investigators will offer iPad-based~     SLT/standard of treatment to a convenience sample of 20 patients with post-stroke~     communication deficits. The primary outcome will be feasibility (recruitment rate, adherence~     rate, retention rate, and protocol deviations), and the secondary outcome will be~     improvement in PSCD.~   "
33772|NCT02615119|"~     This study aims to identify the brain regions responsible for encoding cardiorespiratory~     'interoceptive' sensations and determine whether they are dysfunctional in individuals~     affected by anxiety, depression, eating disorders or brain injury. By evaluating the same~     interoceptive sensations across different human illnesses, the investigators hope to provide~     convergent evidence resulting in identification of core underlying neural processes, and to~     discern relative contributions in each condition.~   "
33773|NCT02615106|"~     The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus~     Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.~   "
33774|NCT02615080|"~     This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial~     evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007~     will be given as add on to a background of commonly used controller medication, i.e. inhaled~     corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing~     the background controller medication, the efficacy and safety of CRD007 will be evaluated on~     top of several dose levels of this medication.~   "
33775|NCT02615067|"~     99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with~     newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason grade of ≤~     3+4 severity and / or are candidates for active surveillance, but have planned to undergo~     radical prostatectomy. In these patients, the results may be used to help estimate the risk~     of a histopathologic Gleason grade of > 3+4. This Phase 3 study is designed to evaluate the~     specificity and sensitivity of 99mTc-MIP-1404 to detect clinically significant prostate~     cancer when compared to histopathology.~   "
33776|NCT02615054|"~     This is for participants with a history of HER2-positive breast cancer and were treated with~     chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart~     function) is a new method of monitoring heart function in cancer patients and is measured~     with an ultrasound. Exercise testing is another method that can be used to monitor for~     abnormal heart function in cancer patients. The purpose of this study is to see if strain~     and exercise testing can be used to detect for late signs of heart damage from chemotherapy.~   "
33777|NCT02615041|"~     The study was a randomized three-way crossover study. Each subject received meropenem in~     three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem~     over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump~     at a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an~     infusion pump at a constant flow rate every 8 h for 24 h.~      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE~     II score, BUN, Cr, Blood culture will be collected.~      Nine patients will be enrolled in this study. After completion of the meropenem therapy for~     3 days in this study, all patients will receive other sensitive antibiotics to eradicate~     their bacterial infections.~      Meropenem pharmacokinetic studies were carried out during administration of the third dose~     of each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5~     ml) were obtained by direct venipuncture at the following times: before (time zero) and 10~     and 30 min and~      1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen.~      The concentrations of meropenem were determined by reverse-phase high-performance liquid~     chromatography.~      Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer~     model) to get PK/PD index (40%T>MIC) and reported to % PTA(Probability Target Attainment)~     and %CFR (Cumulative Faction Response)~   "
33778|NCT02615028|"~     To develop a force plate with a proper computing algorithm that can be used in the average~     household as well as within community care centers. An affordable price range will also be~     necessary.~   "
33779|NCT02615015|"~     Neutrophil extracellular traps (NETs) and deoxyribonuclease (DNase) activity determine~     outcome in ST elevation acute coronary syndrome (STE-ACS). DNase single nucleotide~     polymorphisms (SNPs) were increased in a japanese cohort.~      In the present study, the investigators seek to measure DNase SNPs frequency in a caucasian~     STE-ACS cohort compared to healthy controls (each n=400). The investigators will compute~     polymorphisms, DNase activity, NET surrogate markers and clinical variables in regression~     models.~   "
33780|NCT02615002|"~     This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine~     (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on~     efficacy (cognitive performance), safety and tolerability in patients with mild dementia due~     to AD.~   "
33781|NCT02614989|"~     This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS~     patients with disabling refractory tremor.~   "
33782|NCT02614976|"~     Padding with cuff during blood pressure is expected to reduce number of skin crease or~     petechiae incidence.~   "
33783|NCT02614963|"~     Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome~   "
33784|NCT02614950|"~     This is a Phase 2, two-step, open-label study of the outcome of analytic treatment~     interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage~     I of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen~     or HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as~     HIV-1 RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be~     monitored closely for safety and will have ART re-initiated if they meet predefined~     clinical, virological, or immunological criteria. In step I, there will be 8 subjects who~     undergo ATI. An interim analysis for safety will be conducted after 12 weeks. If none of the~     subjects maintain viral suppression at 12 weeks then no further subjects will be enrolled~     into the study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then~     an additional 7 subjects will be enrolled in step 2.~      At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with~     clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then~     on a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any~     pre-defined clinical, immunological or virological safety endpoints during the monitoring~     period.~   "
33785|NCT02614937|"~     This was a prospective, single center, open label, randomized study evaluating the~     biological effect of squalamine lactate ophthalmic solution, 0.2% combined with~     intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central~     and central retinal vein occlusion (BRVO, HRVO, CRVO).~   "
33786|NCT02614924|"~     The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope~     would be a more effective device compared to flexible fibreoptic scope (FOS) for awake~     intubation in a difficult airway.~   "
33787|NCT02614911|"~     This study has been set up in order to characterize phenotypes and genotypes of patients~     with early onset enteropathies.~      In that goal, Investigators will collect biological samples (mainly blood) of patients~     suffering from early onset enteropathies and their healthy relatives.~   "
33788|NCT02614898|"~     This is a prospective, open-label study with no patient randomization. Treatment for~     atypical hemolytic uremic syndrome (aHUS) will remain observational and at the discretion of~     the treating physician. The purpose of this study is to assess disease manifestations of~     complement mediated thrombotic microangiopathy (TMA) and potential clinical predictors of~     disease manifestations and progression in patients with aHUS with or without eculizumab~     treatment in the clinical setting.~   "
33789|NCT02614885|"~     This is a single-arm, prospective study of a radiofrequency ablation device on the excised~     breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by~     the device will be analyzed histologically.~   "
33790|NCT02614872|"~     This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung~     transplantation.~   "
33791|NCT02614859|"~     Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an~     elevated insulin level in the blood is associated with a shorter median time to cancer~     progression and median overall survival in patients with an elevated PSA after prior~     treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently~     used in this patient population,with no proven benefit, which may increase mortality and~     morbidity.This study evaluates how metformin in combination with bicalutamide affects~     prostate cancer.~   "
33792|NCT02614846|"~     This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in~     Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study~     receive Hetrombopag.~   "
33913|NCT02613169|"~     Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium~     tuberculosis infection in HIV-exposed uninfected (HEU) infants.~   "
33794|NCT02614820|"~     Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary~     disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid~     is the only proven effective medicine,while side effects limit its use. Recent studies have~     shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in~     ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of~     resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.~      Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and~     control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a~     blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while~     control group will receive a similar stimulus (inflation of a blood pressure cuff on the~     bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels~     of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of~     lower limbs）at 0 days, 3 days, 3months ,6months.~      Purpose：~        1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD~          patients~        2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.~   "
33795|NCT02614807|"~     High blood pressure is very common among elderly Canadians. Clinical trials show clear~     benefit from lowering blood pressure in hypertensive elderly patients. These trials also~     demonstrate safety for several classes of blood pressure lowering drugs including water~     pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can~     cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and~     very elderly. Causes are age related decrease in kidneys' ability to get rid of water and~     low salt coupled with high water intake. A standard approach to treatment is lacking since~     higher salt intake may worsen hypertension, and lower water and higher protein intake is~     difficult to understand and actually implement. 'Nepro' is a nutritional drink high in~     protein, and low in potassium and sodium. It is used frequently as a dietary supplement in~     patients with kidney disease specifically for low sodium and high protein content. The high~     protein content in Nepro can help the kidney get rid of excess water, and the low sodium and~     potassium content will make this a safe option to use. Hence investigators propose a~     proof-of-concept trial on an easy to understand and administer, and relatively affordable~     solution to this issue. It could be summarized in one sentence: Will a bottle of Nepro a~     day keep thiazide-caused hyponatremia and the doctor away?~   "
33796|NCT02614794|"~     The purpose of this study is to assess the effect of tucatinib vs. placebo in combination~     with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on~     independent central review.~   "
33797|NCT02614781|"~     This study is a non-interventional prospective, multicenter, longitudinal study conducted in~     France, among a representative sample of public and/or private birth control centers.~      The aim of the study is to assess, in real-life settings, the success rate of the protocol~     Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or~     beyond 7 weeks of amenorrhea.~   "
33798|NCT02614768|"~     The purpose of this study is to assess accuracy and reliability of the SPIDIMAN CGM sensor~     system with regard to values as measured by Super GL and compare these results with similar~     evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor~     and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.~   "
33799|NCT02614755|"~     The primary objective of this observational study is to determine performance~     characteristics and usability of Lumosity and the Brain Performance Test in a group of older~     adult volunteers.~   "
33800|NCT02614742|"~     This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in~     Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.~   "
33801|NCT02614729|"~     The purpose of the main study is to determine whether the daily consumption of protein-rich~     meals containing high quality, lean beef products improves appetite control and cognitive~     function during a weight maintenance diet.~      The purpose of the sub-study is to determine whether the daily consumption of protein-rich~     meals containing the same amount of high quality, lean beef products improves appetite~     control and cognitive function during a modest energy restriction, weight loss diet.~   "
33802|NCT02614716|"~     The main purpose of this study is to learn more about the safety and side effects of the~     study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will~     also evaluate how much of the study drug gets into the blood stream and how long it takes~     the body to remove it.~   "
33803|NCT02614703|"~     Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose~     a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in~     detecting neoplasia.~   "
33804|NCT02614690|"~     This study aims to examine the need for univalve or bivalve splitting of casts in pediatric~     patients with forearm fractures following closed reduction and cast application in a~     randomized, prospective fashion.~   "
33805|NCT02614677|"~     Before 2007, the disability evaluation was based on the medical model in Taiwan. According~     to the People with Disabilities Rights Protection Act announced on 11 July 2007, the~     assessment of a person's eligibility for disability benefits has to be determined as~     suffering one of eight malfunction categories based on the International Classification of~     Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue~     a disability identification and other welfare & services need processes of evaluation &~     assessment based on the ICF framework for the evaluation report and result of living need by~     the committee composed of professionals from medicine, social work, special education and~     employment counseling and evaluation.~      In this year, investigators planed the project with the Taiwan Society of ICF to develop the~     evaluation form. The experts from various disciplines of the ICF Office convened internal~     integration meetings to reach a consensus for developed the ICF evaluation form, add the~     code of pain and sleep and the items from Short-Form 12 for quality of life to the~     questionnaire. The results were used to analysis other relevant factors affecting the~     disability evaluation. And then add the core set from World Health Organization to both~     physical and mental disorders linked coding group, compared the new disability evaluation~     system and evaluate the living need of people with disability to provide suggestion for core~     set.~   "
33914|NCT02613156|"~     This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of~     recurrent hepatocellular carcinoma (HCC).~   "
33806|NCT02614664|"~     Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid~     atresia) frequently have feeding difficulties necessitating procedures such as Nissen~     fundoplication and G-tube placement. With advances in minimally invasive surgery, these are~     frequently performed using laparoscopic techniques. Although generally safe and effective,~     the increase in IAP during laparoscopy may increase systemic and pulmonary vascular~     resistance and decrease cardiac output. This prospective study will include 50 patients with~     single ventricle physiology presenting for laparoscopic procedures. There will be no change~     in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation~     will be monitored using near infrared spectroscopy (NIRS).~   "
33807|NCT02614651|"~     The main objective of this study is to quantify vision parameters in subjects with~     concentric visual field constriction, and this in relation to the display on virtual reality~     goggles. More specifically:~        -  The maximum brightness value for visual comfort (THRESHOLD_MAX)~        -  The minimum value of the perceptible light contrast in low light perceptible~          (THRESHOLD_MIN)~        -  The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and~          [THRESHOLD_MIN-THRESHOLD_MAX].~   "
33808|NCT02614638|"~     The main objective of this study is to evaluate the impact of the presence of a pharmacy~     technician in a care unit (Hepato-Gastroenterology Department) on detected medication~     errors.~      This is a before-after study consisting of three sequential phases:~      Month 1: one month of observation of what is happening in the department Month 2: one month~     wash out period Month 3: active participation of a pharmacy technician in the department~   "
33809|NCT02614625|"~     An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new~     clinical applications has recently been published in the peer-reviewed literature. However,~     the successful use of SD-OCT in routine clinical use depends upon the diagnostic~     sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective,~     comparative, observational study aims to evaluate the imaging quality and diagnostic~     performance of two commercially available SD-OCT machines for both the anterior and~     posterior segment of the eye.~   "
33810|NCT02614612|"~     To determine if INCB039110 in combination with corticosteroids is safe and tolerable in~     patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).~   "
33811|NCT02614599|"~     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial~     effects in behavior and brain connectivity of different dietary patterns in 100 children~     with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.~   "
33812|NCT02614586|"~     The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic~     marker) in auditory sensory gating is demonstrated after administration of TAK-058 and~     ondansetron compared to placebo in participants with schizophrenia.~   "
33813|NCT02614573|"~     The main objective of this study is to evaluate, for a 6-month observation period, the~     concordance in terms of clinical decision making concerning therapeutic adjustment as~     determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy~     versus the usual strategy in a population of dependent elderly people in nursing homes,~     treated with anti-vitamin K (AVK).~   "
33814|NCT02614560|"~     This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab~     talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine~     in sequence with standard treatments before a planned stem cell transplant, or as~     maintenance therapy after a stem cell transplant. The main purpose of the study is to find~     the best dose and determine the anti-leukemic activity of vadastuximab talirine, given~     either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or~     refractory AML. This will be determined by assessing the safety and tolerability of~     vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity~     of the study treatment will be assessed.~   "
33815|NCT02614547|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects~     diagnosed with severe postpartum depression~   "
33816|NCT02614534|"~     The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy~     (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal~     carcinoma is effective in the treatment of locally advanced colorectal carcinoma.~   "
33817|NCT02614521|"~     Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to~     3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death.~     Patients with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response~     are potential candidates for RF ablation of AF. The success rate of RF ablation in the~     treatment of AF varies depending on the type and duration of AF (ie, paroxysmal vs~     persistent), structural remodeling of the heart, co-morbidities and the technique of the~     cardiac electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up.~      To study and predict the successful outcome of RF ablation is of great clinical importance.~     Moreover, the detection of predictive factors for successful outcome may alter the~     therapeutic strategy determining a subgroup of patients in the need of more invasive~     management.~   "
33818|NCT02614508|"~     This phase I trial studies the side effects and best dose of buparlisib when given together~     with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has~     returned after a period of improvement or does not respond to treatment. Buparlisib and~     ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different~     ways by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may~     work better in treating patients with chronic lymphocytic leukemia.~   "
33819|NCT02614495|"~     A multi-center , opened, Phase II study to assess the efficacy and safety of Sulfatinib 300~     mg Sulfatinib in advanced Medullary Thyroid Carcinoma ( MTC) and iodine-refractory~     differentiated thyroid carcinoma (DTC).~   "
33820|NCT02614482|"~     The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its~     efficacy for overactive bladder syndrome in children.~   "
33821|NCT02614469|"~     The purpose of this study is to assess the effects of food on the amount of urate in the~     body after a single oral dose of inosine.~   "
33822|NCT02614352|"~     Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and~     Atorvastatin 40mg in healthy male subjects.~   "
33823|NCT02614339|"~     The aim of this study is to identify the effect of adjunctive metformin on recurrence of~     non-DM stage III colorectal cancer. This study is open-label randomized controlled study.~      The primary endpoint is to compare the 3-year disease free survival between metformin group~     and non-metformin group. The secondary endpoint is to compare the 5-year overall survival~     and disease specific survival between two group, to identify the safety of metformin, and to~     compare the recurrence rate of polyps after polypectomy between two groups.~   "
33824|NCT02614326|"~     A wealth of research has demonstrated that they way in which the investigators recall our~     personal, autobiographical memories is influential in the course of depression. Biases in~     the recall of autobiographical memory occur in the midst of a depressive episode, and are~     shown to prolong symptoms, however these biases also remain when depression remits, and may~     predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to~     train individuals to be flexible in their retrieval of autobiographical memories, and~     thereby reduce depressive relapse. Changes in memory bias may also have an effect on~     intermediate processes that increase risk of depression, such as rumination, impaired~     problem solving, and cognitive avoidance. This feasibility trial compares the effects of~     MemFlex and Psychoeducation in their ability to reduce memory bias and intermediate~     cognitive risk factors, and thereby depressive relapse, in individuals remitted from Major~     Depressive Disorder. Clinical outcome and process measures will be assessed immediately~     following completion of the intervention, at 6 months post-intervention, and at 12 months~     post-intervention. If encouraging, the results of this pilot trial may provide a foundation~     for a later phase trial.~   "
33825|NCT02614313|"~     Background: Breath testing for food intolerances is becoming routine in patients with~     functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances~     (FODMAPs: fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose,~     sorbitol) are common (>10% of any given population) and often respond to dietary~     modification. The breath tests are based on quantification of gas excretion in breath as a~     sign of malabsorption and symptom provocation, but are likely subject to considerable~     psychological bias. The role of expectation and other psychological effects on breath~     testing has not been reported, but is crucial for the validation of these increasingly~     wide-spread tests with considerable dietary and potentially deleterious consequences.~     Fructose has been shown to result in short term pro-inflammatory metabolic responses, but~     these effects have not been studied as underlying causes for intolerance symptoms in~     fructose intolerant patients with FGID.~      Aim: To investigate the psychological component and the short-term metabolic effects of~     fructose breath testing in patients referred for evaluation of FGID using placebo.~     Additionally, to assess baseline predictors for a positive breath test result.~      Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption~     (defined by increased breath hydrogen/methane concentrations) will be determined in 30~     successive male and female FGID in a single centre using breath-testing. Fructose 35g, given~     double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a~     neutral (still water) placebo given double-blind will be compared in a randomized,~     cross-over sequence and according to our standardised procedure on four separate study days.~     Symptoms will be recorded using standardised questionnaires and breath concentrations of H2~     and CH4 will be measured during testing on the four study days. Somatisation and~     psychological profiles will be assessed by questionnaires. Blood samples will be obtained~     before and during provocation testing to assess short-term responses to fructose loading by~     metabolomics. Fructose, blinded and open, and placebo responses will be compared and~     baseline predictors for a positive breath tests assessed.~   "
33826|NCT02614300|"~     Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some~     chronic respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although~     clinical guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE)~     discuss the benefits of these programs in quality of life and exercise tolerance, evidence~     of such intervention in nCFBE patients is insufficient. Longer studies are needed with~     larger sample sizes and optimized to maximize the response and maintain long-term benefits.~     The present study aims to examine the effects in exercise tolerance of a pulmonary~     rehabilitation program combined with respiratory physiotherapy in patients with nCFBE. It is~     a randomized controlled clinical trial with a total duration of 24 months. The intervention~     will be performed during 12 weeks and then will be a period of 12 months of maintenance.~     This is a multicenter study involving the following Hospitals: Hospital Clinic, Hospital la~     Plató and Hospital del Mar of Barcelona, Hospital Josep Trueta of Girona, Royal Infirmary of~     Edinburgh and Fondazione Maugeri di Lumezzane of Italy. Subjects will be randomized into~     three groups in a ratio (1: 1: 1) (1) Pulmonary Rehabilitation (2) Chest Physiotherapy and~     (3) Pulmonary Rehabilitation + Chest Physiotherapy. Hospital la Plató from Barcelona will be~     responsible for carrying out the Control Group. The primary endpoint will be the test of~     endurance shuttle walk test.~   "
33827|NCT02614287|"~     The main purpose of this study is to evaluate the longer term safety of the study drug known~     as LY2951742 in participants with episodic or chronic migraine.~   "
33828|NCT02614274|"~     The Nutramax test article is a nutritional supplement that contains several ingredients~     shown to potentially provide benefit to patients suffering from a painful and sometimes~     debilitating condition of the knee called osteoarthritis.~      This is a pilot study that is intended to determine whether results from a proprietary~     testing panel conducted on blood and urine samples will correlate with data from physical~     examination and validated surveys that measure participants' quality of life and physical~     capabilities.~   "
33829|NCT02614261|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY2951742 in participants with chronic migraine.~   "
33830|NCT02614248|"~     The purpose of the study is to examine the safety and effectiveness of the use of coconut~     oil for the prevention and treatment of diaper dermatitis among NICU babies at Genesis~     Medical Center, Davenport.~   "
33831|NCT02614235|"~     The purpose of this study is to determine whether continuous cardiac telemetry with the~     Pocket-ECG III® system is more useful than conventional Holter to find out the cause of~     syncope~   "
33832|NCT02614222|"~     The objective of this research is to determine if the addition of the Clear Guide ONE, a~     Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing~     ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can~     visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician~     better guide the needle to the target.~   "
33833|NCT02614209|"~     Plasma specimen collected from patients presenting in the Emergency Department (ED) with or~     without Heart Failure (HF) and prescribed a BNP.~   "
33834|NCT02614196|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY2951742 in participants with episodic migraine.~   "
33835|NCT02614183|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY2951742 in participants with episodic migraine.~   "
33915|NCT02613143|"~     The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma~     through an anterior approach.~   "
33836|NCT02614170|"~     The study objectives are described below:~        1. Obtain matched serum, plasma [(K2 EDTA, Sodium Heparin (NaH), Lithium Heparin (LiH)]~          and urine specimens collected from a minimum of 50 healthy subjects. Specimens will be~          used to determine a reference range for C-peptide and insulin assays, used as an aid in~          the assessment of C-peptide and insulin in adults.~        2. Obtain serum and urine specimens collected from a minimum of an additional 200 healthy~          subjects. Specimens will be used to determine a reference range for C-peptide and~          insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.~        3. To store any remaining specimens for use in future assay development and to evaluate as~          yet undetermined assays for the development of IVDs, including additional C-peptide or~          insulin assays.~   "
33837|NCT02614157|"~     Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced~     rectal cancer. As for the treatment strategies on LLN metastasis, there are huge~     controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant~     chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort~     evidences indicate that LLND following total mesorectal excision (TME) will bring benefit~     from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on~     the contrary. Existing reports tend to recommend LLND for specific individual with~     suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control~     study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare~     the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN~     metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum~     protein) to predict local recurrence and overall survival will be further investigated.~   "
33838|NCT02614144|"~     This project aimed at analyzing and assessing of the early and late Hospital-Acquired~     Pneumonia(HAP) bacterial pathogens and their resistance to antimicrobial agents. The~     incidence of their resistance to antimicrobial agent is assessed. Included are patients~     hospitalized in the Intensive Care Departments of cooperated University hospitals, who~     developed early or late HAP. Bacterial pathogens and their resistance to antibiotics are~     identified using standard microbiological methods. The patient's mortality with respect to~     their initial antibiotic therapy is statistically analyzed.~   "
33839|NCT02614131|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY2599666 in different groups of people - those who are healthy, those who have~     mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate~     AD. The study will measure how much LY2599666 gets into the bloodstream and how long it~     takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The~     study has three parts. Part A will last about 2 months. Parts B and C will each last about~     23 weeks. Participants may only enroll in one part.~   "
33840|NCT02614118|"~     The aim of this study is premedication efficacy of analgesics on post endodontic pain.~     Sixty-six healthy adult volunteers including criteria, are participating. The patients will~     be divided into 3 groups and will be randomly given one of pre medications including 1) 10~     mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before~     applying the injection. All patients will receive standard root canal treatment. Patients~     will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success~     will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be~     analysed using Mann-U-Whitney and Kruskal-wallis tests.~   "
33841|NCT02614105|"~     The primary aim of the study is to investigate whether pelvic floor muscle training or~     cough-suppression therapy reduces symptoms of urinary incontinence amongst women with~     chronic obstructive pulmonary disease grade 1-4 (mild to very severe disease).~   "
33842|NCT02614092|"~     This two-year study will evaluate the feasibility of an exercise training augmentation for~     cognitive training intervention to improve memory performance in Veterans with a diagnosis~     of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise~     phase and 2) a cognitive training program. The exercise phase will be an aquatic based~     exercise program. A combination of exercise and cognitive training programs designed for~     persons without cognitive impairment have significantly improved memory more than other~     single intervention groups (exercise only, cognitive training only) and given the success of~     combination training programs with healthy older adults, it is important to adapt these~     programs for persons beginning to exhibit clinically significant memory problems, such as~     those with aMCI.~   "
33843|NCT02614079|"~     This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial~     using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction~     achieved correlates with the degree of stimulation.~   "
33844|NCT02614066|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).~   "
33845|NCT02614053|"~     The purpose of this study is to evaluate the use of continuous noninvasive intraoperative~     plethesmography variability index in conjunction with Hemoglobin levels monitoring using~     Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with~     antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .~   "
33846|NCT02614040|"~     This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal~     saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A)~     for intravenous fluid administration in the emergency department.~   "
33847|NCT02614027|"~     To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently~     available antiretroviral drugs, and the prevalence of associated metabolic syndrome in~     HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the~     severity of fat accumulation and antiretroviral drug use.~   "
33848|NCT02614014|"~     Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease~     (IBD) and the quality of life of these patients. A second aim is to establish the existence~     of any psicopathological profile in these patients. We designed a prospective experimental~     study were patients are randomized to receive or not a cognitive-behavior program. Patients~     will be evaluated at 3 and 12 months after the program and study variables will be measured:~     stress level, coping strategies, quality of life, activity of disease and biological~     variables related to IBD.~   "
33849|NCT02614001|"~     Objectives: Little has been known the effectiveness of respiratory muscle training in~     patients with both stroke and heart failure. To investigate the feasibility and~     effectiveness of the inspiratory muscle training (IMT) in the respiratory muscle strength,~     cardiopulmonary function, exercise capacity, fatigue and quality of life in stroke patients~     with congestive heart failure.~      Design: A single-blind prospective randomized controlled study. Setting: A tertiary care~     medical center. Participant and method A total of twenty stroke patients with stable CHF,~     class I-III [NYHA (New York Heart Association)], aging between 20 to 85 year-old, will be~     eligible and randomly assigned into IMT and control group. Stroke will be confirmed by~     computerized tomography or magnetic resonance imaging. And CHF will be confirmed by a~     cardiologist. Both of groups will receive a conventional stroke rehabilitation program and~     diaphragmatic breathing training. The IMT groups will be trained daily, 30 minutes per day,~     at least 5 times a week, for 4 weeks; then readmitted to hospital 2 weeks later. For~     checking the compliance of IMT at home, patients will be monitored by making a phone call to~     them twice a week. Or patient will receive an out patient program about 10 weeks if they are~     not admitted to our hospital.~      Main outcome measurement:~      Each subject's baseline characteristics, and duration of the disease, neurological level~     (Brunnstrom's stage), functional level, spirometry; resting heart rate, blood pressure,~     resting oxyhemoglobin saturation (SpO2), lowest resting SpO2, maximal inspiratory pressure,~     maximal expiratory pressure, the resting oxyhemoglobin saturation (SpO2), lowest resting~     SpO2 and Borg's scale during a 6-minute walking test , handgrip strength, visual analog~     scale for severity of fatigue, fatigue assessment scale, Barthel scale will be assessed~     before and after program.~   "
33850|NCT02613988|"~     This clinical trial studies advanced MR imaging techniques in measuring early response of~     standard treatment may become predictors of long-term treatment response in patients with~     newly diagnosed glioblastomas.~   "
33851|NCT02613975|"~     Positional therapy is considered as a kind of conservative treatment especially for patients~     with OSA which varies with body positions, and has been reported to be useful in selected~     cases especially those with positional OSA. Positional OSA is present when the overall apnea~     hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other~     positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group~     1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They~     will be provided with a vibration device as treatment, which will be worn on the neck during~     sleep. This device senses the position of the patient during sleep. It will vibrate when the~     patient lies supine until the patient turns laterally, thus prevents the patient to lie flat~     during sleep and reduce the severity of OSA. It will be switched on and off for a period of~     15 days alternatively with sleep study performed at the end of each period respectively to~     determine its efficacy in the on and off mode. There will be a wash out period of 1 week in~     between the on and off period to remove any residual effect. Group 2 consists of patients~     with positional OSA who are using dental device but response or tolerated poorly. They will~     use the vibration device with dental device together as dual therapy, to assess the role of~     combination therapy. The device will be operated in on and off mode with sleep study being~     performed in a similar manner as in group 1. Informed consent will be signed. Each~     participant will have 2 sleep studies performed at home, which will be supported technically~     by technician visiting their home for hook up of necessary equipment.~   "
33852|NCT02613962|"~     In the light of the development of high-throughput technologies enabling a biology-based~     reclassification of tumors and the increasing number of available specifically targeting~     anticancer agents the era of precision medicine has begun. Several clinical precision~     medicine trials with the aim of stratifying treatment according to molecular profiles (for~     example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01,~     SHIVA, PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of~     this approach. MOSCATO-01 is the first trial worldwide including pediatric patients,~     performing an on-purpose intervention and molecular profiling in recurrent tumors. Together~     with more than 500 adult patients, between December 2012 to August 2014, the tumors of 35~     children and adolescents have been profiled, confirming that this approach is feasible in~     pediatric patients albeit with accelerated time stringencies. Importantly, the results of~     the first children and adolescents profiled showed that 2/3 of patients had 'actionable'~     alterations using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014).~      The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of~     tumor tissue to increase the number of targetable genomic alterations. Furthermore to~     improve understanding of the overall molecular profile and possible response to treatment,~     methylation array, miRNA expression profiles, and study of immunomodulators will be~     performed on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials~     centers) - SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and~     bioinformatics platforms will contribute with their expertise in molecular profiling~     projects and characterization of pediatric cancers. Data interpretation of molecular genetic~     alterations detected by WES and RNA Seq and treatment recommendation will be done within a~     multidisciplinary therapeutic molecular biology tumor board.~      'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed~     tumors reported to date, and thanks to increased access to clinical trials since the~     European pediatric legislation, the investigators expect that 20-30% of patients can be~     stratified into a targeted trial based on the detected profile.~      It is the investigators' intention that this initiative paves the way to enrich ongoing~     clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an~     earlier access to targeted agents, and will play a crucial role in the relevant development~     of these new agents in pediatric malignancies.~   "
33853|NCT02613949|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients~     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up~     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 45~     fibromyalgia patients will be randomized into one of three study groups. One of these groups~     will receive sham treatment, meaning they will receive no treatment at all. A second group~     will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1).~     A third group will receive active RINCE treatment at a higher than nominal signal amplitude~     level (treatment mode 2). The study's primary outcome measure will be the difference between~     active and sham treatment groups in the mean change from baseline in patients' 24-hour~     recall average pain scores. The study's hypothesis is that there will be a difference~     between treatment groups in primary outcome measure.~   "
33854|NCT02613936|"~     80 patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 2~     years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study~     they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left~     dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (40~     active, 40 sham) combined with cognitive training. On day 10 NP testing will be obtained~     again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of~     life, depression, and post concussive symptoms will be assessed.~   "
33916|NCT02613130|"~     This study will assess changes in oral malodor and other factors in response to using a~     two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.~   "
33917|NCT02613117|"~     This study will assess the oral tolerability and immediate post-treatment safety of topical~     application for two marketed oxalate products as initial care in dental patients to treat or~     prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.~   "
33855|NCT02613923|"~     Participants are asked to participate in a research study of the effect of a sleep~     intervention on improving sleep habits and reducing their risk of breast cancer.~      Participants are asked to participate in this research study because they have been~     identified as being at higher than average risk of developing breast cancer.~      The purpose of this study is to compare women who get a sleep intervention to women who do~     not get a sleep intervention. This study team will compare these two groups of women to see~     if the sleep intervention improves their sleep and if it lowers markers of inflammation that~     have been associated with an increased risk of breast cancer.~   "
33856|NCT02613910|"~     This study is designed as a multi-country, multicenter, open label extension to Phase III~     trial OPV116910. The primary objective is to provide continued treatment with ofatumumab~     subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain~     further long term safety and tolerability information in subjects with pemphigus vulgaris~     receiving ofatumumab SC every 4 weeks (wk).~   "
33857|NCT02613897|"~     This is a 16-week, single center, randomized, double-blind, active-controlled,~     parallel-group, Phase 3b efficacy and safety study of simultaneous administration of~     saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus~     placebo for saxagliptin, and placebo for saxagliptin plus placebo for dapagliflozin in~     patients with Type 2 diabetes who have inadequate glycemic control on metformin or~     metformin/sulfonylurea.~   "
33858|NCT02613884|"~     Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than~     or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to~     participate in this study. Upon consent, they will be given oral cholecalciferol~     supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed~     by measuring a serum calcium level within 1 week of supplementation. Efficacy will be~     assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be~     assessed with the previous two measures as well as a brief questionnaire administered via~     telephone within 1 week of supplementation.~   "
33859|NCT02613871|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in~     chronic genotype 1 or 2 HCV infected adults who are co-infected with HBV in Taiwan.~   "
33860|NCT02613858|"~     The Preempt study is likely to help determine the frequency of patients suffering from~     Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know~     about the Quality of life of these patients.~   "
33861|NCT02613845|"~     The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes~     delirium as a disturbance in attention (i.e., reduced ability to direct, focus, sustain,~     and shift attention) and awareness (reduced orientation to the environment). In addition, a~     disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial~     ability, or perception) occurs.~      Postoperative delirium (PD) usually develops in connection with a surgical procedure within~     the first five days after an intervention. Roughly 10-70% of all surgical patients above the~     age of 65 years are affected.~      PD places not only a burden to the patient and their families by increasing functional and~     cognitive damages, and increasing mortality, it also has a high impact on the health care~     resource utilization. A patient with PD often requires more intensive care, has a longer~     length of hospital stay, more complications, and often requires long-term care after being~     discharged from the hospital. All these aspects show the need for prevention of PD.~      There are various preoperative risk factors that influence the development of PD. Broad~     research has been done on this topic and shown that advanced age, cognitive impairment,~     depression and other psychopathologic symptoms, intake of psychotropic substances, sensory~     impairment like decrease in visual or auditory perception, impairment in daily life~     activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity~     of disease and different comorbidities, such as chronic cardiac insufficiency, atrial~     fibrillation, or previous history of stroke or infections may favor the occurrence of PD.~      The incidence of PD is among the highest in cardiac surgery. The study was designed to~     assess predictors for PD after cardiac surgery. Study hypothesis is that some patient~     variables, scores and biomarkers are not only predictive of the incidence of PD but also of~     the severity of delirium-associated symptoms and duration of PD after cardiac surgery.~   "
33862|NCT02613832|"~     The survival of patients with lesions in the central nervous system is usually accompanied~     by physical and mental sequelae. These impairments favor the prolonged restriction to the~     bed, which may contribute with changes in respiratory function. In this context, lung~     re-expansion techniques are used to prevent or treat the various respiratory complications.~   "
33863|NCT02613819|"~     This study is evaluating the activity and efficacy of Stereotactic Ablative Body~     Radiotherapy (SABR) for the treatment of kidney cancers.~   "
33864|NCT02613806|"~     Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative~     bleeding.Postoperative bleeding is a serious and potentially life-threatening~     complication，which could result in acute upper airway obstruction due to neck hematoma and~     increase the need for re-operation.The purpose of this study is to investigate whether~     dexmedetomidine can reduce the incidence of postoperative coughing and contribute to~     postoperative recovery in patients undergoing tyroid surgery with general anesthesia.~   "
33865|NCT02613793|"~     This study is recruiting two groups of women over the age of 18; those who are pregnant and~     who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is~     to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the~     long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to~     seizures in pregnancy (eclampsia) and may prove fatal for mother and child.~      Currently the only effective treatment for pre-eclampsia is control of the mother's blood~     pressure until it is safe to deliver the baby. The timing of delivery is kept under constant~     review by the medical team, who must balance the risk to the mother of developing eclampsia~     against the risk to the baby of being born too early (premature).~      If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it~     effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their~     limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these~     reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing~     this is not easy, so we want to assess whether measuring other reaction times might~     similarly help assess the risk of seizures. One possibility is by measuring the reaction~     time as we flick our eyes to follow a moving target, using an instrument called a~     saccadometer, which is worn on a head-band, a little like a head-torch.~      By comparing the results between these groups and the non-pregnant women, we will be able to~     see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if~     so, whether saccadometry might be useful in helping doctors decide the best time for safe~     delivery.~   "
33866|NCT02613780|"~     Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to~     significant visual deterioration over time. Corneal collagen crosslinking with riboflavin~     (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate~     the need for corneal transplantation. However, the treatment alone has little impact in~     terms of improving visual function. Photorefractive keratectomy (PRK) is the application of~     an excimer laser to treat a patient's refractive error, therefore decreasing the dependence~     on spectacles or contact lenses for improved vision.~      Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to~     partially correct the refractive error in keratoconic patients, whilst simultaneously~     stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign~     system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced~     high-resolution aberrometer. It is capable of mapping highly aberrated corneas for~     wavefront-guided laser procedures, and represents an important technological advance in~     treating corneal disease.~      The purpose of this single center, prospective pilot study is to assess the safety and~     efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using~     the iDesign® aberrometer. Results of this pilot study will be used to provide sample size~     estimates for an extension of the study, which aims to determine whether sequential or same~     day procedure leads to better outcomes.~   "
33867|NCT02613767|"~     There are an increasing number of individuals in the United States with obesity, and this is~     a major health concern with links to many chronic diseases. Impairments in protein~     metabolism with obesity may disrupt muscle function and modify the dietary protein~     requirements in obese individuals. Further, overweight and obese type 2 diabetics exhibit~     dramatically reduced skeletal muscle mass compared with lean, healthy controls.~     Surprisingly, the influence of being overweight or obese on this decline in muscle mass~     remains understudied, despite clear evidence that similar metabolic impairments typically~     exist in these populations prior to the development of overt diabetes. Protein ingestion~     provides the amino acid building blocks to synthesize and repair muscle proteins in adults.~     Previous research has shown that the muscle protein synthetic response to food ingestion may~     be reduced in overweight/obese adults. However, this research provided the 'free' amino~     acids in small portions every 15 min during the postprandial period. In free living~     conditions, however, it is more common to consume protein dense foods in single portions.~     Currently, there is no information available on how eating protein rich foods affects muscle~     protein synthesis in overweight and obese adults. This proposed research will fill this~     research gap by being the first study to compare the muscle protein synthetic response to~     the ingestion of a meal-like amount of high quality protein in lean, overweight and obese~     adults. The objective of this study is to determine the muscle protein synthetic response~     after the consumption of 35g pork protein in lean, overweight and obese adults. In order to~     assess this objective the researchers propose to use primed continuous infusion of~     L-[ring-13C6] phenylalanine to measure muscle protein synthesis rates after the consumption~     of dietary protein. In a parallel design the researchers will study 13 obese (BMI 30-39.9~     kg/m2) participants, 13 overweight (BMI 25-29.9 kg/m2), and 13 age-matched lean controls~     (BMI 18-24.9 kg/m2) between the ages of 20 and 45 years. All subjects will be sedentary and~     weight stable for the previous 6 months. On the test day, subjects will remain sedentary for~     the determination of muscle protein synthesis in both the fasted state and after consumption~     of the protein meal. Blood and muscle sampling will occur on the test day.~   "
33868|NCT02613754|"~     The aim of this study is to conduct a trial to investigate the efficacy of adding~     Contingency Management (CM) to Treatment as Usual (TAU) for the treatment of Disordered~     Gambling. Results from this experiment will provide the first evidence of the additional~     efficacy of best-practice CM and whether it can be easily integrated into a clinical~     environment. Additionally, this study will correlate clinical outcomes with psychological~     measures and participant responses to develop new predictive treatment outcome measures.~   "
33869|NCT02613741|"~     Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and~     since childhood obesity is a major risk factor for adult obesity and also because it is not~     established whether or not this is due to an increase in the FSR of fibrinogen, the~     investigators set up the studies with the following specific aims:~        1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in~          childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean~          age and sex matched controls~        2. To determine the outcome of a three month non-pharmacological intervention (physical~          exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and~          apoB-100~        3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and~          its potential implications on CVD before and after the non-pharmacological intervention~        4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine,~          insulin, free fatty acid, HDL & LDL cholesterol and blood pressure in response to~          weight reduction (as consequence of a combined program of diet and exercise).~   "
33870|NCT02613728|"~     The goal of this clinical research study is to learn if RecoverMI care can help to shorten~     the time that patients are in the hospital after surgery and if it can help them recover~     sooner.~      RecoverMI includes the following parts:~        -  Preoperative Education~        -  Early oral intake~        -  Early mobilization~        -  Telemedicine~   "
33871|NCT02613715|"~     The main aim of this study is to evaluate the bioavailability of blackberry juice~     anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.~   "
33872|NCT02613702|"~     This study will compare a new technique of free gingival graft to the original one, in order~     to evaluate the stability of the graft volume over one year and other variables. Twenty~     patients will receive the original technique of free gingival graft (controls) and twenty~     patients will receive the modified technique, in which the free gingival graft is submerged~     (tests), at the inferior incisors area.~   "
33873|NCT02613689|"~     The purpose of this study is to evaluate the feasibility, acceptability and preliminary~     efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS)~     text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural~     population.~   "
33874|NCT02613676|"~     In South Africa, healthy term newborns are usually discharged early (<72 hours after~     delivery). Many studies have shown that hospital readmission rates have increased with this~     practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of~     newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have~     already been discharged putting the infant at increased risk of severe hyperbilirubinemia.~     Severe neonatal jaundice still constitutes an important cause of neonatal mortality and~     morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before~     hospital could help in early identification of hyperbilirubinemia and early intervention and~     potentially prevent unwanted consequences like bilirubin induced neurological dysfunction.~     However, there are conflicting recommendations on the use of universal transcutaneous~     bilirubin screening for jaundice in all newborns before hospital discharge.~   "
33875|NCT02613663|"~     A successful implant therapy require appropriate hard and soft tissue, perfect implant~     position, appropriate alveolar ridge architecture and integration of the implant. after~     tooth extraction bone resorption takes place and affect the quantity and quality of the bone~     resulting in inadequate bone volume for implant placement and future prosthetic restoration~     and impair the esthetic, so insertion of implant immediately following tooth extraction~     reduce bone loss and enhance esthetics.the fresh socket of extracted tooth is wider than the~     implant diameter and the distance between the implant and the bone called Peri-implant gap~     which influence the stability, osseointegration of the implants and esthetics. using bone~     graft in this gap between bone and implant enhance osseointegration and post-operative~     healing. autogenous bone graft considered the gold standard graft material for filling~     defects as it is osteogenic,osseoconductive and osseoinductive, however this approach~     obtained from the primary donor site for harvesting bone in the oral cavity which requires~     longer surgical procedure and produce not enough bone volume. there are several~     post-operative complication may happen as donor site morbidity and swelling,discomfort and~     pain, so alternative treatment has been suggested using biomaterials to fill the gap and~     reduce adverse effect of autogenous grafts.Several studies evaluate the success rate of~     implants with autogenous bone graft versus other synthetic guided bone regeneration~     materials. Nano porous grafting material as a new synthetic material nanobone~     nanocrystalline hydroxyapatite embedded in a porous silica gel matrix has oseoconductive and~     biomimetic properties integrate with the host bone. the sub-micron modification in bone~     substitutes enhance osteogenic property. the objective of this study is to measure surgical~     time, pain, implant stability and marginal bone loss in immediate implant placement with~     using autogenous bone graft versus nanobone graft.~   "
33876|NCT02613650|"~     This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose~     (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical~     benefit rate and additional safety parameters of the treatment combination~   "
33877|NCT02613637|"~     Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly~     Diagnosed or Existent Lung Cancer~      The LuCa Biology and Outcome (BiO)-Project~   "
33878|NCT02613624|"~     The study is being conducted to develop an intervention to assess the feasibility of~     implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a~     community setting. A prototype intervention package will be developed using information~     obtained from in-depth interviews, focus group discussions and other qualitative research~     techniques. These interviews will help us identify current behaviours, barriers to adoption~     of KMC and effective ways to promote KMC in the community. The prototype intervention will~     be refined by conducting acceptability studies (household trials) with few mothers. The~     study team are identifying LBW and preterm infants, demonstrating to mothers how to practice~     KMC and following up till KMC is stopped. The process is being documented using observations~     and interviews. Information is obtained on acceptability of KMC, number of hours per day and~     number of days KMC was given, breastfeeding practices and support provided by other family~     members.~   "
33879|NCT02613611|"~     Examination of cervical &urine samples for HPV~   "
33880|NCT02613598|"~     The primary objective of this research study is to determine the maximum tolerated dose~     (MTD) of Ruxolitinib (Jakafi) in combination with standard dose Bortezomib (Velcade) in~     patients with relapsed or refractory Hodgkin (HL) and Non-Hodgkin Lymphoma (NHL).~   "
33881|NCT02613585|"~     Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This~     study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and~     the surrounding area that will address the following study aims: 1) Evaluate the~     effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme~     endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and~     3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI~     clothing.~   "
33882|NCT02613572|"~     Because of its iron-chelating and antioxidant properities, alpha lipoic acid may be a~     treatment for geographic atrophy secondary to age-related macular degeneration. There is~     ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults.~     However, there is not much data on the safety and tolerability of higher doses of alpha~     lipoic acid in the elderly population. The purpose of Phase I of this protocol is to~     determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic~     acid are taken by subjects 65 years of age or older.~      The objective of Phase 2 of this protocol is to determine the effects of ALA on the~     progression of GA in subjects with AMD. The central hypothesis, based on the existing~     literature, is that oral ALA reduces the rate of enlargement of GA in AMD subjects. The~     rationale is that the antioxidant and iron chelating effects of ALA will slow down one of~     the major pathways responsible for GA progression.~   "
33883|NCT02613559|"~     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and~     tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal~     antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related~     macular degeneration (wAMD) subjects.~   "
33884|NCT02613546|"~     This research is a randomized clinical trial aims to evaluate the influence of~     cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients~     with sexual dysfunction. The notion of sexual health for the World Health Organization~     exceeds the concept of sickness absence, having a subjective well-being of significance in~     the spheres of self-concept, self-image, interpersonal relationships and sense of self~     worth. Furthermore, sexual satisfaction and relationship quality of life is also evidenced~     in many studies. CBT is a brief and focal psychotherapy with proven efficacy in several~     mental disorders, improving health and quality of life of the treated populations. However,~     they did not find clinical trials that showed the effectiveness of CBT in Sexual~     Dysfunctions. This study aims to then fill this gap by evaluating the relationship from the~     use of techniques of CBT.~   "
33885|NCT02613533|"~     The water drinking test (WDT), is a predictive test that has been used to detect primary~     open angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension~     curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior~     chambers and narrow angles are highly desirable to detect patients prone to angle closure~     glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking~     test in patients with narrow angles who are scheduled for prophylactic laser iridotomy.~   "
33886|NCT02613520|"~     The present trial will evaluate safety and tolerability as well as the vaccine-induced~     humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children,~     and infants who receive doses of 1.8x10^6, 9.0x10^5, 4.5x10^5 or 2.7x10^5 PfSPZ of PfSPZ~     Vaccine by direct venous inoculation (DVI),compared with control groups receiving normal~     saline (NS) placebo by DVI. In addition, as an exploratory objective, controlled human~     malaria infection (CHMI) will be used to assess efficacy in adults three weeks following~     immunization.~   "
33892|NCT02613442|"~     Objective: To determine the clinical variables that influence aqueous outflow facility (Co)~     and intraocular pressure (IOP) in uveitis.~      Uveitic glaucoma is potentially blinding and occurs in 17-46% of chronic uveitis patients.~     Uveitic activity causes fluctuating IOP due to decreased Co, increased uveoscleral outflow~     or decreased aqueous production.~      Specific Aim 1: To evaluate the risk factors for high IOP and low Co in uveitis Hypothesis:~     Decreased Co and increased IOP will occur with increasing anterior chamber (AC) flare, AC~     cells, degree of synechial angle closure, increased duration of disease, higher uveitis~     activity and increasing steroid use Specific Aim 2: To determine prospectively the effect of~     AC flare on Co and IOP in quiescent uveitis Hypothesis: AC flare even in the absence of AC~     cells will cause progressive decline in Co.~      Methods: In this proof of concept study, thirty consecutive patients with acute or chronic~     uveitis will be recruited from the uveitis clinic. Ten patients with quiescent uveitis (no~     AC cells) will be recruited for the prospective arm and followed every 2-3 months for 3~     visits. Co will be measured using 2-minute pneumatonometer tonography. The effect of risk~     factors on IOP and Co in uveitis will be studied using generalized linear modelling~     techniques. These risk factors include AC flare (using the laser flare meter), AC cells,~     degree of angle closure (by gonioscopy), duration of disease, disease activity and~     corticosteroid use within the last year. In the prospective study, the patients will be~     divided into subgroups with low flare (< 20ph/ms) and high flare (≥ 20 ph/msec) and the~     change in Co and IOP will be analyzed.~      Impact: This will be the first study to systematically analyze the risk factors for decrease~     in Co and increase in IOP in uveitis and to prospectively evaluate the effect of AC flare on~     Co. Proof that AC flare can damage the trabecular meshwork will corroborate previous~     experimental evidence and change the paradigm of uveitis treatment. Knowledge of the risk~     factors that affect Co and IOP will aid in identifying patients that may need escalation of~     their uveitis or glaucoma treatment to prevent optic nerve damage.~   "
33893|NCT02613429|"~     Literature shows that anaesthetists have a low success-rate when trying to access the airway~     percutaneously in case of failed ventilation and intubation.~      The study will investigate anaesthetists ability to locate the trachea and the thyroid~     cartilage and the cricoid cartilage in patients, using different methods including~     application of ultrasonography.~   "
33894|NCT02613416|"~     This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection~     monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are~     currently not receiving anticancer treatment with hormonal therapies, chemotherapy, or~     radiation. All patients will undergo quantification of breast density by MRI at baseline 1,~     baseline 2 (after 3-month observation period) and after 3 and 6 months on denosumab, which~     means after 0, 3, 6 and 9 months after entering the study. Because the therapeutic agent is~     an injectable drug, the investigators will conduct a single arm study with both pre- and~     post-treatment measurements to determine the extent of variability in breast density over~     time and a placebo treatment period or group will not be utilized. This is an investigator~     initiated trial and Amgen (SPONSOR) will provide the trial drug denosumab.~   "
33895|NCT02613403|"~     This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172~     (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks~     with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC)~     hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously~     failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered~     as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.~      The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682~     and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of~     participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all~     study therapy.~   "
33896|NCT02613390|"~     The goal of this clinical research study is to learn about the safety and accuracy of using~     MRI as a guidance system during laser ablation surgery of tumors that have spread to the~     spine.~   "
33897|NCT02613377|"~     Transfusions cause more adverse events in children than in adults. Patients in pediatric~     intensive care units (PICU) are particularly exposed to transfusions of plasma-rich blood~     products (red blood cell (RBC), plasma and platelets) and the risk of adverse events after a~     transfusion is particularly high in this vulnerable population. Transfusion-related acute~     lung injury (TRALI), an acute inflammation of the lungs that impairs gas exchange leading to~     acute respiratory failure, is one of the 2 most deadly transfusion complications in the~     general population. There is limited evidence on TRALI incidence and impact in critically~     ill children. This reduces the awareness of PICU team for this complication, and makes the~     decision process to transfuse particularly difficult. Moreover, acute lung injury is highly~     prevalent in critically ill children. It is therefore complex to ascertain if the high~     frequency of respiratory deteriorations observed after a transfusion in PICU is explained by~     the transfusion itself or by the evolution of the patient's critical illness.~      The investigators will conduct a cohort study of consecutive transfused critically ill~     children, with a control group of matched non-transfused children. The primary objective is~     to determine if transfusion of RBC, plasma and/or platelets in PICU is an independent risk~     factor of TRALI, and to compare the respiratory evolution in the two matched (transfused and~     non-transfused) groups. The secondary objectives will include the determination of the~     incidence rate, risk factors and clinical impact of TRALI in transfused PICU patients. The~     investigators will study both classic TRALI and delayed TRALI.~   "
33898|NCT02613364|"~     This randomized phase III trial compares yoga, survivorship health education program, and~     cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors.~     Insomnia can be described as excessive daytime napping, difficulty falling asleep,~     difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue,~     impair physical function, impair immune function, cause circadian rhythms (known as the~     biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian~     rhythms, physical and immune function, and improve insomnia and sleep quality in cancer~     survivors. It is not yet known whether yoga is more effective at treating insomnia than a~     health education program or cognitive behavioral therapy program.~   "
33899|NCT02613351|"~     The aim of this study is to determine if: the large muscles of the leg, activated during~     walking, are also active during scooting; whether scooting alters the relationship between~     leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.~   "
33918|NCT02613104|"~     Previous research suggests that people with bipolar disorder have trouble accurately~     identifying emotions. The goal of this study is to test a novel intervention, emotion~     recognition modification (ERM), to help improve the ability of young people with bipolar~     disorder to identify emotions.~   "
33941|NCT02612805|"~     This study evaluates the effects of the combined exercise training (aerobic more resistance)~     and of the aerobic exercise training isolated compared to control group, which performed~     only stretching and relaxation, in the treatment of type 2 diabetes (T2DM). The two exercise~     interventions and the control procedure are performed in aquatic environment.~   "
33900|NCT02613338|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Specifically, posterior~     stabilizing (PS) knees have been found to be associated with lower amounts of posterior~     femoral rollback, higher occurrence of reverse axial rotation and increased amount of~     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB)~     knee system has incorporated subtle changes in its design to address restoration of~     kinematics that more closely resemble those of a normal knee. To understand if this design~     is able to effectively restore kinematics in the implanted knee, further in vivo analysis is~     necessary. This continuation of the study will analyze 30 subjects with the Attune PS FB 3~     months post-operatively using the University of Tennessee's mobile fluoroscopy unit while~     performing three daily activities, level walking, ramp down and deep knee bend.~   "
33901|NCT02613325|"~     The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate~     both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed~     by histological examination, the investigators anticipate that they will be able to~     non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma,~     tumor depth (Breslow's depth) is not only an important prognostic indicator, but also~     directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that~     will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in~     melanoma diagnosis and management - potentially an earlier and more definitive surgical~     management.~      In addition, the investigators propose to use the combination of fPAM and single-cell PAM to~     respectively image CTCs in trunk vessels and cuticle capillaries. Based on the~     investigators' murine models, the investigators anticipate that they will be able to~     differentiate CTCs from other blood cells and reliably calculate CTC concentration in a~     non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a~     melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The~     ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation~     of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.~   "
33902|NCT02613312|"~     The purpose of this study is to determine the response rate and overall survival in patients~     that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and~     intensity modified radiation therapy (IMRT) as part of their standard of care.~   "
33903|NCT02613299|"~     The purpose of this study is to determine whether radiation therapy decreases tumor size and~     tumor spread. The investigators will consent subjects that have been diagnosed with~     mesothelioma and will undergo radiation therapy followed by surgical resection as their~     standard of care. The investigators will collect data from past and future medical records~     as well as data regarding their health status for their lifetime by reviewing life status,~     treatment status and CT scans.~   "
33904|NCT02613286|"~     This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof~     of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial~     hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical~     hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.~   "
33905|NCT02613273|"~     This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the~     effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance~     exercise vs. usual care in men with metastatic castration resistant prostate cancer to~     determine the safety, feasibility, and tolerance of exercise; quality of life indicators,~     and a prognostic score.~   "
33906|NCT02613260|"~     Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health~     Network and access to care may be limited so novel models of health care delivery are~     warranted. The objective of this study is to examine whether a centralized panel management~     model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake~     of CRC screening and could be developed and sustained within the typical parameters of~     cost-effectiveness and budget impact analyses.~   "
33907|NCT02613247|"~     Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic~     population, particularly amongst runners. The standard of care treatment for PFPS is a~     comprehensive active rehabilitation program. Eighty percent of patients with PFPS report~     improvement in their symptoms with such a program. Unfortunately, the remaining twenty~     percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the~     enormous number of individuals running for fitness, PFPS represents a significant challenge~     to public health as the investigators strive to encourage active living in our society.~      A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has~     been suggested in scientific literature. Given that intra-articular viscosupplementation~     (hyaluronic acid) injections have shown clinically significant symptom improvement in knee~     osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial~     for therapy-resistant PFPS.~      Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely~     movable joints (such as the knee). It is believed to contribute to lubrication and~     cushioning in these joints. The composition of synovial fluid within arthritic joints is~     altered, resulting in reduced fluid viscosity and elasticity. One modern formulation of~     hyaluronic acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a~     single injection and will be utilized in this clinical trial.~   "
33908|NCT02613234|"~     The prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability and mortality~     rate. The 128-channel electroencephalograph (EEG), combined with BESA dipole localization~     method, is able to provide more specific information about the brain activity and find out~     the epileptogenic focus. Based on this novel EEG recording method, cathode transcranial~     direct current stimulation (tDCS) targeting the epileptogenic focus can be used to decrease~     the excitability of the cortex, thus reducing the frequency of seizures. A single-center~     single-blinded randomized controlled and open-label extension trial will be carried out to~     study the efficacy of 128-channel electroencephalograph combined with BESA dipole~     localization method and Intervention on brain waves for epilepsy.~   "
33909|NCT02613221|"~     To evaluate the combination of panitumumab and TAS-102 in patients with RAS wild-type~     metastatic colorectal cancer (CRC) refractory to standard chemotherapy (oxaliplatin,~     fluoropyrimidines, irinotecan and anti-VEGF therapy).~   "
33919|NCT02613091|"~     In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that~     the drug clemastine has a negative effect on patients' color discrimination, which is the~     ability to distinguish different hues and arrange them in the correct order. In an upcoming~     clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess~     color visual performance adding assessment of color defectiveness as a clinical endpoint.~     Color defectiveness is the ability to see certain colors, and is commonly referred to as~     color-blindness. Color discrimination and defectiveness can be related, but do not always~     correlate. This study aims to detect the effect, if any, that clemastine has on color~     defectiveness in healthy controls, which could confound its use as an outcome endpoint in~     future clinical trials relating to clemastine.~   "
33920|NCT02613078|"~     Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic~     nutritional supplement (SymbioLact B) on gastrointestinal symptoms in children with~     functional abdominal pain or irritable bowel syndrome compared to self-observation only. The~     study also includes collection of psychometric data (emotional and behavioral problems, pain~     coping strategies), data on activity of the autonomous nerve system as measured by heart~     rate variability and data on stress response (saliva cortisol levels).~   "
33921|NCT02613065|"~     The purpose of this project is to determine if protein is less likely to create positive~     energy balance when added to the diet compared to carbohydrate. To do this, the~     investigators will take detailed measurements of participant's baseline metabolic rate to~     understand their energy requirements. Then, the investigators will feed participants all~     their meals for two weeks, Monday-Friday, and measure their food intake. During one of the~     week-long feeding periods, participants will consume a shake made of egg protein that is~     ~20% of their energy requirements. During the other week, participants will consume a shake~     made of carbohydrate that is ~20% of their energy requirements. Participants will drink the~     assigned shake at the beginning of each of their daily three meals, and then they will be~     offered a 'regular' meal of unlimited quantity. Participants will not know that the~     investigators are measuring the food consumed after drinking the shake. Participants will~     drink the protein shake for the first week and carb-based shake for the second week, and~     vice versa-- depending on the randomization order. To account for energy expenditure,~     participants will wear an activity monitor, an accelerometer. Energy balance, measured as~     participant energy intake minus energy expenditure, will be our main outcome for each~     treatment. However, because participants may change their behavior if made aware of the true~     research question, the investigators will tell participants that the purpose of the study is~     to see how low fiber and high fiber shakes affect mood. The hypothesis is that during the~     week when participants consume the protein shake, they will remain in energy balance, but~     during the week of carbohydrate shake consumption, participants will have positive energy~     balance.~   "
33922|NCT02613052|"~     This is a prospective, randomized, controlled study to determine if albumin and propofol or~     albumin only will provide superior qualitative contrast enhancement during TEE bubble~     studies compared to agitated saline. Each patient will receive three randomized bubble~     studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated~     contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3~     mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble~     studies by 10 different anesthesiologists and/or cardiologists credentialed to read~     echocardiographic studies at the time of the surgical procedure, and also with retrospective~     review of the echo video (~200 studies). A bicaval view will be obtained to record a 20 beat~     loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and~     30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.~   "
33923|NCT02613039|"~     Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To~     reduce androgenic side effects of first- and second-generation progestins, several new~     progestins derived from progesterone or spironolactone have been developed in the last few~     decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed~     to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or~     glucocorticoid actions.~      However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual~     dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and~     partner's quality of life. Moreover, available data indicate that OC use might increase~     adiposity in adolescents and might be associated with central redistribution of body fat in~     young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in~     clinical anthropometric measurements, including body mass index and waist circumference.~      In this context, it would be worth to evaluate the effects of combined OCs on metabolic and~     sexual health (sexual desire, arousal, and other parameters of sexual health), body image~     and mood.~   "
33924|NCT02613026|"~     The purpose of this study is to compare the short-term and long-term efficacies and the~     safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide~     followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.~   "
33925|NCT02613013|"~     This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral~     iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI~     to control the progression of primary angle closure with multi-mechanism based on the UBM~     classification.~   "
33926|NCT02613000|"~     Importance of gastrointestinal (GI) function in critically ill patients has been recognized,~     but until now there is no validated clinical tool to monitor GI dysfunction as part of~     multiple organ dysfunction syndrome (MODS). The general aim of current project is to develop~     a five grade score (0-4 points) for assessment of GI function similar to SOFA sub-scores~     used for assessment of other organ systems. 500 consecutive adult patients admitted to the~     intensive care unit will be monitored for gastrointestinal symptoms, intra-abdominal~     pressure (IAP) and acute gastrointestinal injury (AGI) grades [1]. In 200 patients from~     these, plasma and urinary levels of possible biochemical markers of intestinal injury will~     be assessed.~      Objectives:~        -  To determine the prognostic value of gastrointestinal symptoms alone and in combination~          with intra-abdominal pressure (IAP), and acute gastro-intestinal injury (AGI) grades in~          predicting the ICU-, 28 days and 90 days mortality of adult intensive care patients~          (Part A of the study)~        -  To describe the blood and urine levels of biochemical markers of intestinal injury in~          general cohort of intensive care patients (Part B of the study).~        -  To compare the prognostic values of the intestinal-specific plasma parameters (IFABP,~          citrulline, ILBP, and D-lactate) with the gastrointestinal symptoms, AGI grades, and~          the SOFA score in predicting of ICU-, 28 days and 90 days mortality of adult intensive~          care patients (Part B of the study) Study design: prospective, observational,~          multicenter study Patient population: All consecutive adult critically ill patients (25~          to 50 patients for each study site, 500 patients in total) in need for intensive care~          admission during maximum 4 weeks of study period.~      Duration of the study: for the individual patient 7 days and follow-up of 90 days Primary~     study outcome: 28 and 90 days all-cause mortality Secondary outcomes: ICU and hospital~     mortality, ICU length of stay, hospital length of stay, duration of mechanical ventilation,~     multiple organ failure as a cause of mortality, plasma and urinary levels of intestinal~     fatty-acid binding protein (I-FABP), citrulline, ileal lipid binding protein (ILBP), and~     D-lactate in general cohort of intensive care patients.~   "
33927|NCT02612987|"~     Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It~     is well-known that insomnia can exacerbate the concurrent psychiatric symptom load.~     Treatment of insomnia has been extensively examined in adults, but studies with adolescents~     are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of~     internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children~     and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT.~     Outcome will be measured at pre treatment, at post treatment and at a three months~     follow-up. Weekly assessments will also be made during treatment on primary outcome and a~     presumed process variable constructed for the purpose of this trial.~   "
33928|NCT02612974|"~     This study has been designed to conduct as Randomized comparative clinical study.~   "
33929|NCT02612961|"~     A long-standing intervention during tracheostomy tube suctioning in acute care settings is~     use of saline to loosen and remove respiratory tract secretions, maintain airway patency,~     and prevent mucus plugs. Controversy exists regarding safely using saline prior to~     suctioning for head and neck cancer and mechanically ventilated patients. To date, all~     studies had methodological limitations. In 2013, the clinical consensus statement published~     by AAO-HNSF identified a research gap based on lack of strong scientific evidence. A single~     site, randomized controlled pilot study will be conducted to evaluate effects of saline~     instillation with tracheostomy tube suctioning; test feasibility of proposed methods and~     procedures; and ensure proposed outcome variables are measurable and not confounded by~     extraneous variables. Institutional review board approval will be obtained before eligible~     adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen~     saturation and heart rate are primary outcome variables; secondary outcome variables are~     mucus plugs and ventilator-associated pneumonias; other demographic data and patient~     characteristic variables; and outcome variables on complications and length of stay. Mean,~     standard deviation, median, and interquartile range will be calculated for continuous~     variables using t-tests to compare pre- and post-assessment scores. Frequencies and~     percentages will be calculated for categorical variables using Chi square and Fisher Exact~     tests to compare pre- and post-assessment scores. Multiple regression analysis will be used~     to control for confounding variables. This study is innovative as the first to recruit both~     head and neck cancer patients and mechanically ventilated patients and to measure all major~     outcomes of interest in one study. Understanding the effects of normal saline instillation~     will enable development of evidence-based guidelines and standardized protocols for~     tracheostomy tube suctioning.~   "
33930|NCT02612948|"~     Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically~     ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length~     of stay.~   "
33931|NCT02612935|"~     In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an~     open-label, 12-month pilot study of computerized cognitive training as part of the cognitive~     wellness program in order to evaluate (1) the user experience of Lumosity in individuals~     with MS, and (2) the efficacy of Lumosity for improving cognitive outcomes in individuals~     with MS.~   "
33932|NCT02612922|"~     Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute~     uncomplicated influenza.~   "
33933|NCT02612909|"~     The purpose of this study is to determine a safe and effective dose of IVAC A/H5N1 vaccine~     for licensure in Vietnam. The first phase (Phase 2) will compare two doses of the vaccine.~     Based on the outcome of the Phase 2, the Vietnam MOH will determine if Phase 3 can be~     conducted.~   "
33934|NCT02612896|"~     Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with~     significant economic and public health impacts, occurring primarily in developing countries.~     Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host~     develops the metacestode larval stage (porcine cysticercosis). However, people can also act~     as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC)~     when the central nervous system is involved.~      The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan~     Africa (SSA) have focussed on single control options. It is becoming clear that these~     stand-alone options have the potential to reduce the occurrence of the parasite, however~     either long term or more integrated efforts seem to be required to reach an elimination~     status.~      The objective of the current study is to evaluate the cost-effectiveness/acceptability of~     elimination (to be achieved on a short term via integrated measures), and control (single~     measures, with an elimination goal on a longer term) of T. solium in a highly endemic area~     in SSA.~      This intervention study will entail an elimination study arm in which multiple control~     options are combined (integrated) aiming at the final human host (Mass drug administration~     (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a~     second study arm a single control option will be carried out (pig treatment). In both study~     arms (health) education will be implemented. At baseline and in the final sampling year,~     prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in~     all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig~     sampling will be conducted in the elimination study arm, as well as two-yearly (biennial)~     sampling of the pig intermediate host in the control study arm. Additionally, (open ended)~     questionnaires and focus group discussions will be administered/held to obtain data on the~     cost of pig keeping, T. solium, the interventions and the perception/acceptability of the~     proposed control measures to the local communities.~   "
33935|NCT02612883|"~     Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses.~     Compromised microperfusion in the area where the anastomosis is sited likely contributes to~     leaks, but until now there has not been an easy and reliable technique to intraoperatively~     evaluate microperfusion.~      Objectives: To assess the association of intraoperative flux measurement with postoperative~     outcome of patients undergoing major abdominal surgery.~      Trial design: Prospective observational study. Flux measurement will be carried out using~     the moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied~     on the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and~     measurements will be documented after a stable signal has been obtained.~   "
33936|NCT02612870|"~     Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1~     day before surgery, which enables the surgeon to localize the sentinel lymph node during~     surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes~     either 1 or 4-6 days before surgery to investigate the concordance with the standard~     technique.~   "
33937|NCT02612857|"~     The purpose of this study is to determine how safe and effective IMO-8400 is in adults with~     dermatomyositis.~   "
33938|NCT02612844|"~     This trial is conducted in Europe. The aim of the trial is to investigate the Safety,~     Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and~     Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous~     NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes~   "
33939|NCT02612831|"~     The creatinine clearance will be measured using two consecutive 24 hour urine collections,~     with the objective of minimizing errors due to poor quality urine collection.~      The GFR will be measured by a reference method, because its estimation from blood creatinine~     levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and~     therefore creatinine production, following bariatric surgery. The method will remain the~     same in each center, and therefore consistent for any given patient, throughout the duration~     of the study. The GFR measurements will be performed after stopping any medication blocking~     the RAAS, and reducing diuretics for one week, with the introduction or increase of~     alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop~     RAAS-blockade (heart failure), the dose will at least be reduced for one week. This~     precaution is required to minimize the bias of functional renal insufficiency because the~     state of extracellular hydration is difficult to assess in obese subjects. Subsequent~     measurements of GFR will be performed in the same way.~      The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA,~     99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is~     hazardous in extremely obese patients and because kidney disease favors edema formation, the~     simplified single injection method and the determination of plasma clearance measurement of~     the tracer is not reliable . Only the constant infusion method will be used to measure GFR.~     Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma~     concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant~     plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several~     consecutive clearances. Because correct urine collection is key for the procedure, seven~     collection periods (instead of 5 usually) will be performed for the calculation of the mean~     clearance. Bladder catheterization will be used only when it can be anticipated that the~     patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60~     ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore,~     this might occur exceptionably in the study. Raw data from each center will be sent to the~     coordination center (Nice) to examine and validate the calculation of mean clearance values.~     To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7~     periods will be taken into account to calculate the mean values. For instance, in the last~     30 consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on~     average 4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min.~      Primary assessment will be performed at one year, as a previous study has already suggested~     a significant benefit within this period [66], and because surgery can't be delayed further~     in these patients strongly expecting the intervention, but follow-up will be extended to~     three years or until the end of the study, in order to document whether the initial benefits~     of surgical intervention are maintained.~        -  A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is~          expected in the first six months after surgery (M0 - M6). However, the weight loss may~          allow an increased in mGFR indexed to body surface area up until M6, and above all~          towards M12.~        -  the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the~          bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in~          the control group who remain in a state of glomerular hyperfiltration.~      All relevant cardiovascular, metabolic and nutritional parameters necessary to study the~     risk/benefit ratio of the intervention will be analyzed.~        -  Primary: bariatric surgery slows the progression of chronic kidney disease in the~          obese.~        -  Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic,~          nutritional and inflammatory parameters, quality of life, and access to transplantation~          in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could~          be a chance loss for the patients in delaying surgery by one year.~   "
33940|NCT02612818|"~     Thus is a longitudinal, prospective, multicentric observational study performed in mainland~     France, among a sample of gynaecology surgeons practising at endometriosis expert centres.~      The aim of this study is to describe, under real treatment conditions in patients suffering~     from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy~     surgery on the development of clinical signs in the patients and their fertility at one~     year.~   "
33942|NCT02612792|"~     The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV~     gel in treatment of mandibular degree II furcation defects in comparison to PRF and open~     flap debridement (OFD) alone.~   "
33943|NCT02612779|"~     This is a Phase 2, multi-center, open-label, single arm study of elotuzumab in combination~     with pomalidomide and low dose dexamethasone to assess the safety and efficacy of this~     combination therapy for treatment of MM patients who have relapsed after or are refractory~     to a prior treatment with a lenalidomide-based regimen. Seventy-two subjects will be~     screened and a minimum of 60 subjects will be enrolled and treated by the combination. The~     estimated duration of enrollment is 18 to 24 months, minimum of 24 months follow-up and~     study duration of about 48 months.~   "
33944|NCT02612766|"~     The purpose of this study is to determine the safety and tolerability of oats in gluten free~     diet.~   "
33945|NCT02612753|"~     Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on~     social, family and professional lives. Aphasic patients need to be rehabilitated. To date,~     no pharmacological treatment being available only speech and language therapy (SLT) can~     improve patients, but its efficiency is moderate. Several studies have investigated the link~     between the recovery of language and neural reorganization. tDCs, a noninvasive technology~     for modulating neural excitability, could potentiate the effects of the SLT. About 25~     studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic~     patients. However to the investigator knowledge the feasibility of tDCs and speech therapy~     in clinical pathways has never been investigated. That is why the investigator propose to~     study in real care conditions how SLT proves more efficient on the recovery of language in a~     discursive assessment when coupled with active stimulation than with placebo stimulation.~   "
33946|NCT02612740|"~     The aim of this study was to evaluate the effect of the use of deproteinized bovine bone as~     a filler material of critical-sized (diameter >=20 mm) bony defects derived from the~     excision of maxillary and mandibular cysts. 20 patients were considered.~      Patients were randomly divided into 2 groups according to the type of treatment: the bone~     defect was filled with granules of deproteinized bovine bone (test); no filling material~     (control). Clinical parameters were recorded at 7 days, 1, 6 and 12 months after surgery.~     Radiological follow up consisted of an orthopantomograph and a CT scan taken at the baseline~     (pre-operatory) and 12 months after surgery.~      In order to evaluate the difference in percentage of filling of the bone defect between the~     two groups, the pre-op and the 1-year radiolucent volumes were evaluated in the CT scans.~   "
33947|NCT02612727|"~     At present, much of sub-Saharan Africa, including Nigeria and other resource-limited~     countries, are without ready access to CPT, due to factors including the lack of PT devices,~     which are expensive and require consistent electric power to operate. NHB is a significant~     cause of neonatal morbidity and mortality, but preventable when appropriate treatment is~     initiated. We have shown that FS-PT is safe and efficacious for the treatment of~     mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious~     for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but~     more specially as defined as needing phototherapy per American Academy of Pediatric 2004~     guidelines). It will be done at 3 sites in Nigeria (2 in Lagos, Nigeria and 1 in Ogbomoso,~     Nigeria). The rationale for conducting the study is that in Nigeria, and other countries~     that cannot afford effective commercial light devices and/or have no reliable electric power~     to operate them, filtered sunlight phototherapy might offer a safe and effective treatment~     for neonatal jaundice.~   "
33948|NCT02612714|"~     Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal~     study detected the effects of rosuvastatin on free testosterone levels and sexual function~     in men with type 2 diabetes.~      Methods:~      Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical~     assessments include serum total cholesterol (TC), low-density lipoprotein (LDL),~     high-density lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing~     hormone, follicle stimulating hormone, total testosterone and serum sex hormone binding~     globulin (SHBG). All parameters are measured before statin treatment, after 6 months of~     statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual~     health inventory for men (SHIM) are also evaluated.~   "
33949|NCT02612701|"~     E-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Many questions~     remain about the size and composition and especially about the potential toxicity of these~     particles. Thus, a key unanswered question—and the research question proposed—is whether~     e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as~     does conventional cigarette smoke, which delivers a very well-defined exposure to fine~     particles and many fold greater exposure to toxic (combustion) products including volatile~     organic compounds (such as acrolein) that have been implicated in the pathogenesis of~     tobacco-related coronary disease.~      Because the effects of nicotine on the human coronary microcirculation remain incompletely~     defined—with multiple potential vasodilator and vasoconstrictor actions each of which may~     vary by dose—we will determine the comparative effects of conventional cigarette smoke~     against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose~     nicotine.~   "
33950|NCT02612688|"~     This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP)~     Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH~     facilities (intervention arm n=119; control arm n=241) within two NH health care systems:~     Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP~     Video Program, while the control NH facilities will follow their usual ACP procedures. The~     trial will evaluate the effectiveness of the ACP Video Program by comparing~     hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.~   "
33951|NCT02612675|"~     This will be a randomized, cross-over study of two oral nutrition supplements in individuals~     with Type 2 Diabetes.~   "
33952|NCT02612662|"~     This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and~     pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing~     single doses.~   "
33953|NCT02612649|"~     The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD~     Tablets in post-marketing medical practice and to examine the status of treatment~     compliance.~   "
34042|NCT02611492|"~     The Primary objective is to assess the non-inferiority of the experimental arm (arm B)~     compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the~     4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+)~     acute lymphoblastic leukemia (ALL)~   "
33954|NCT02612636|"~     Sleep is a complex physiologic and behavioral process essential for rest, repair,~     well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and~     sensory disengagement from the external environment. Critically ill patients experience poor~     sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and~     intubation for mechanical ventilation are the major sources of anxiety and stress during the~     ICU stay. Many physiological, psychological and environmental factors contribute to the~     incidence of sleep disruption for the ICU patients. The primary physiologic factors~     documented in the literature are pain, medications and illness.The primary psychological~     factors documented in the literature are stress and worry. Environmental factors include~     noise, patient care activities and therapeutic modalities as mechanical ventilation. Our~     research aim will be the impact of effective interventions like use of ear plugs and eye~     mask on decreasing light exposure and promoting sleep in ICU patients.~   "
33955|NCT02612623|"~     This is an 8-week randomized, parallel, double-blind, placebo-controlled study of AF-219 in~     subjects with refractory chronic cough.~   "
33956|NCT02612610|"~     This is a 12-week, randomized, parallel, double-blind, placebo-controlled study of AF-219 in~     subjects with refractory chronic cough.~   "
33957|NCT02612597|"~     In this study the investigators would like to elaborate on the mechanisms that lead to a~     higher insulin sensitivity after exercise training and a lower insulin sensitivity after~     bedrest.~      The investigators speculate that the concomitant chances in blood volume during training and~     bedrest might explain the changed insulin sensitivity because with a changing blood volume~     also the dilution space of the glucose will change.~      Furthermore, the investigators would like to work on the influence of a changed capacity of~     skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity.~      Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with~     obese pre-diabetic patients will be conducted.~   "
33958|NCT02612584|"~     For correct of presbyopia, in this study, the investigators have recruited subjects who aged~     45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface~     disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent~     ophthalmic examination including manifest refraction, uncorrected distance visual acuity~     (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA),~     corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast~     sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam~     ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular~     symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo~     Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on~     dominant eye of participants. The investigators recommend use of pinhole contact lens at~     least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic~     examination same above 2 weeks after first apply of pinhole contact lens. The investigators~     will compare ophthalmic parameters mentioned above before and after wearing pinhole contact~     lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting~     presbyopia.~   "
33959|NCT02612571|"~     The purpose of the present study is to compare rates of glaucomatous optic neuropathy in~     professional wind versus non-wind instrument players in the Philadelphia Orchestra. A~     secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind~     instrument players under variable playing conditions.~   "
33960|NCT02612558|"~     The purpose of this study is to evaluate whether fostamatinib is safe and effective in~     treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).~   "
33961|NCT02612545|"~     Background:~      Malaria is an illness caused by a parasite that enters people s bodies when a mosquito bites~     them. It can cause fevers, headaches, body aches, and weakness. If not treated, it can make~     some people very ill. Malaria can be cured. A mix of 2 drugs that has worked well in the~     past is not working as well in some parts of Cambodia. Researchers want to see if a mix of 3~     drugs works better and is safe.~      Objectives:~      To see if a 3-drug mix can be used to treat malaria in areas where a 2-drug mix is less~     effective.~      Eligibility:~      People aged 2 65 years with mild malaria in Pursat, Preah Vihear, and Ratanakiri Provinces~     in Cambodia.~      Design:~      Participants will be screened with medical history, physical exam, urine and blood tests,~     and an electrocardiogram (ECG). For this, electrodes will be placed on their skin to check~     their heartbeat.~      Participants will spend about 5 nights in the hospital. They will have physical exams and~     will complete symptom questionnaires daily. They will give blood periodically throughout~     their stay. For this, a thin plastic tube is placed in an arm vein for the first day, and~     blood draws using a needle are done after that.~      Participants will get either a 2-drug mix or a 3-drug mix for 3 days. They will have 2 ECGs~     each day of receiving the drugs.~      Participants will have follow-up visits once a week over 5 weeks. At these visits, they will~     have a physical exam and have blood taken. If they have any signs of malaria, they will be~     re-treated.~      The study will last up to 42 days.~   "
33962|NCT02612532|"~     The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy~     of FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.~   "
33963|NCT02612519|"~     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with~     recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the~     Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared.~     All patients will receive medical care for cirrhosis and ascites according to the~     institution's standards of care. Standard of care may include, but is not limited to the~     administration of diuretics, paracentesis and consideration for orthotopic liver~     transplantation.~   "
33964|NCT02612506|"~     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical~     pharmacokinetics in healthy volunteers.~   "
33965|NCT02612493|"~     Obesity is the indication for bariatric surgery in type I diabetes. Interestingly~     postsurgery the patients improve remarkable in their need for insulin, not only in the daily~     total insulin dosage but also in the dosage of IU per kg.~   "
34043|NCT02611479|"~     To identify patient characteristics associated with non-response after spine fusion surgery~     for the treatment of degenerative disc disease (DDD).~   "
33966|NCT02612480|"~     Rationale:~      In patients suffering a myocardial infarction the P2Y12 receptor antagonists prasugrel and~     ticagrelor improve outcome and prognosis compared to clopidogrel. Moreover, ticagrelor~     lowers mortality from pulmonary infections and sepsis, which cannot solely be explained by~     its platelet-inhibiting effect. An effect on the inflammatory response in the setting of~     acute myocardial might underlie this phenomenon and if substantiated support a novel~     beneficial mechanism of the new the P2Y12 receptor antagonists.~      Objective:~      To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory~     response to the administration of lipopolysaccharide (LPS) in humans in vivo, and to compare~     this effect with the P2Y12 antagonist clopidogrel.~      Study design:~      Prospective randomized placebo-controlled trial, according to a PROBE design (prospective~     randomized open blinded-endpoint study).~      Study population:~      Forty healthy male volunteers aged ≥ 18 and ≤ 35 years. Intervention (if applicable):~     Participants will be randomized to receive either placebo (twice daily), acetylsalicylic~     acid (80 mg once daily, after a loading dose of 160 mg) + placebo (once daily),~     acetylsalicylic acid (80 mg once daily, after a loading dose of 160 mg) + ticagrelor (90 mg~     twice daily, after a loading dose of 180 mg) or acetylsalicylic acid (80 mg once daily,~     after a loading dose of 160 mg)+ clopidogrel (75 mg once daily, after a loading dose of~     300mg).~      Main study parameters/endpoints:~      Endpoints: area under the curve of the proinflammatory cytokines TNF-alpha, IL6, IL-10,~     IL1ra IL-8, IL-1β, MCP-1 MIP-1a, MIP-1b en IFN; peak concentrations of the various~     cytokines; plasma concentration of HMGP1; platelet-monocyte complex formation and markers of~     platelet function; plasma concentration of adenosine.~   "
33967|NCT02612467|"~     Background Studies in the United Kingdom find the stratified care model of the STarT Back~     Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients.~     However, considerations on differences in health care and social systems across countries~     are required before taking steps towards any recommendations of implementing stratified care~     into other health care services.~      Objective To investigate the effectiveness of the stratified care model of the SBT, when~     embedded into the regional disease management programs on LBP in primary care as compared to~     current best practice care.~   "
33968|NCT02612454|"~     The primary objective of the study is to assess the long-term safety of dupilumab in~     pediatric patients with AD.~      The secondary objectives of the study are:~        -  To assess the long-term efficacy of dupilumab in pediatric patients with AD~        -  To assess the trough concentrations of functional dupilumab in serum and the~          immunogenicity in pediatric patients with AD after re-treatment with dupilumab.~   "
33969|NCT02612441|"~     Chinese Acupuncture can improve the motor ability of patients after having first acute~     ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in~     minimum receiving number of 3 Acupuncture treatments.~      The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first~     is the treatment when the stroke occurs, and the second is prevention from having more~     cerebral vascular accident in the future.~      In the first accepted treatment line, the only medicinal measure that stand up in critique~     of organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and~     limited time after the CVA occur that it can be used. Also (TPA) can be used only on part of~     the patients with specific defined criterions.~      The aim of this study is to add a new accepted treatment method that appointed to improve~     the results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic~     is unambiguously.~   "
33970|NCT02612428|"~     The primary objective of the study is to evaluate safety and efficacy of ELAD with respect~     to overall survival of subjects with a clinical diagnosis of alcohol-induced liver~     decompensation (AILD) through at least Study Day 91.~      The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a~     chi-squared test.~   "
33971|NCT02612415|"~     A feasibility study to inform the design and conduct of a randomised controlled trial of~     high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for~     non-invasive respiratory support in critically ill children~   "
33972|NCT02612402|"~     A smartphone app will be installed on smartphones of patients with type 2 diabetes or~     hematologic malignancies that do not exercise. The app will send SMS messages to encourage~     exercise. The exercise will be quantified by the smartphone accelerometer and clinical data,~     including HbA1c will be collected.~   "
33973|NCT02612389|"~     This study will explore the a Qigong based exercise intervention, here referred to as~     Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive~     pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a~     beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms,~     affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM~     could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow~     degeneration and improve quality of life.~   "
33974|NCT02612376|"~     This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging,~     and clinical data. These data and samples will be used for future research into the causes~     of Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and~     memory problems. This future research will also study how treatments for these diseases~     work. This research may help develop new treatments for some diseases of the nervous system~     and help understand these diseases better.~   "
33975|NCT02612363|"~     The investigators will conduct a prospective, single-center, randomized, double-blinded,~     controlled study to investigate the effect of early goal directed sedation on~     microcirculation in early septic shock patients.~   "
33988|NCT02612194|"~     Following informed consent and registration, subjects will undergo tissue pre-screen~     eligibility screening. Tumor specimens from potential subjects will then undergo c-MET and~     RON expression characterization. Eligible subjects will then undergo treatment eligibility~     screening and then be enrolled into available open molecularly defined cohorts. If at least~     one response is observed within a cohort, it will be considered for expansion with~     additional subjects enrolled. The cohort showing the highest response rate will be given~     highest consideration, as determined by the Sponsor-Investigator. Trial accrual is~     anticipated to occur over two years with 21 subjects enrolled during the first stage (7 in~     each cohort) with the opportunity for an additional 25 to be enrolled if a cohort is~     expanded. Subjects enrolled will follow the same procedure and treatment schedule,~     regardless of cohort assignment.~   "
33976|NCT02612350|"~     Pathway Genomics Corporation (Pathway Genomics), a San Diego, California company, is~     involved in the development and validation of new molecular diagnostic assays for the~     analysis of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the~     plasma-derived DNA (cell-free DNA or cfDNA) in order to identify specific variants~     (mutations) in cancer driver genes. The purpose of testing for mutations in ctDNA is to~     detect and monitor cancer. All cells shed DNA into the bloodstream. Finding~     cancer-associated mutations in the cfDNA may lead to early detection of cancer in an~     otherwise apparently healthy (i.e. asymptomatic) individual or may allow the healthcare~     provider to more effectively monitor and treat a known cancer patient. The analysis is~     performed using a polymerase chain reaction (PCR)-based methodology where oligonucleotides~     are designed to target specific mutations in designated genes of interest followed by next~     generation deep sequencing of the amplified targets. Evaluation of the performance of these~     assays for screening for cancer in asymptomatic subjects is essential for the clinical~     validation of the use of these assays. The specific aim of this protocol is to obtain~     relevant human blood samples from individual subjects at higher than average risk for the~     development of cancer due to age, heredity, or environmental or toxic exposures for use in~     the statistical analysis of this method as an adjunct screening test for the potential~     presence of cancer.~   "
33977|NCT02612337|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
33978|NCT02612324|"~     The purpose of this study is to determine the impact Pono Choices has among youth for teen~     pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in~     high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward~     healthy sexual behaviors; skills in managing relationships and choices; and intentions about~     future sexual activity.~   "
33979|NCT02612311|"~     This study evaluates the combination of ublituximab, a novel monoclonal antibody, and~     TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and~     compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.~   "
33980|NCT02612298|"~     The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride~     and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in~     patients with essential hypertension. To provide evidence for hypertension treatment.~      A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol~     succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.~   "
33981|NCT02612285|"~     SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of~     the molecular chaperone heat shock protein 90 (Hsp90). Initial in vitro evidence supports~     that SNX-5422 may be active against TP53 null tumors irrespective of tumor type .~   "
33982|NCT02612272|"~     This study will compare the efficacy of intra-articular betamethasone injection to~     intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an~     equivalence study using a double-blinded, randomized, controlled design. Patients will be~     recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448~     patients will be recruited (224 in each group) to receive an administration of an~     intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain~     as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)~     score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee~     Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings.~     Statistical analyses include repeated measures analysis of variance (ANOVA) (primary~     outcome) and selected ANOVA and nonparametric tests as deemed appropriate (secondary~     outcomes), with p < .05 denoting significance for all comparisons, and no adjustment for~     multiple testing.~   "
33983|NCT02612259|"~     A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial~     to assess the safety and efficacy of dietary supplementation with tryptophan to achieve~     weight loss, and its neuropsychological effects in adolescents with obesity.~   "
33984|NCT02612246|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 given to~     healthy subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics)~     will be characterized.~      The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential~     of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored~     as well.~      During the course of the study after multiple oral dose administrations, the effect of~     GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.~   "
33985|NCT02612233|"~     Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis~     of the hands affects millions of people and is a major cause of hand disability and pain.~     Despite this, there are currently no treatments that delay or halt the development of~     osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is~     an important factor to consider in the treatment of this condition. Treatments for pain in~     osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as~     paracetamol. However, most people with osteoarthritis still have pain despite these~     treatments.~   "
33986|NCT02612220|"~     The present randomized controlled trial evaluates the efficacy and safety of BioFoam®~     Surgical Matrix in patients undergoing elective liver resection. In contrast to other~     topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate~     hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce~     the incidence of postoperative complications.~      The primary objective of this trial is to show that time-to-complete hemostasis can be~     reduced using BioFoam® Surgical Matrix as compared to the conventional approach.~   "
33987|NCT02612207|"~     The aims of this project are to validate the performance of the miniaturized and modernized~     hematofluorometer that measures bilirubin capacity into a product and is suitable for~     operation in various point of care environments when encountering confounding direct~     bilirubin, to complete the development of easy to use sample handling disposables, and to~     verify the performance of the system for samples from a specified population of neonates.~   "
33992|NCT02612142|"~     35 participants diagnosed with major depressive disorder were randomized in 3 intervention~     groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no~     intervention (control group; NI). The intervention length was 10 consecutive days. In groups~     1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day.~     Depressive symptoms were assessed the day before the beginning of intervention and the day~     after the end of intervention for participants of both groups.~   "
33993|NCT02612129|"~     A prospective, randomised, double-blind, placebo controlled therapeutic study in patients~     with confirmed diagnosis of NiemannPick disease type C (NPC).~      The purpose of this study is to assess the efficacy and safety of arimoclomol (compared to~     placebo) when it is administered as an add-on therapy to the patient's current prescribed~     best standard of care; patient's standard of care may, or may not, include miglustat.~   "
33994|NCT02612116|"~     The purpose of this study is to evaluate the differences in pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the~     drug administration in patients with unstable angina pectoris.~   "
33995|NCT02612103|"~     Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel~     diseases (IBD). At the time of diagnosis it is not possible to predict the course of the~     disease, which can range from a few flares in a lifetime to uncontrollable disease leading~     to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and~     prognostic tools.~      In chronic inflammation diseases there is an excessive turnover of the extracellular tissue.~     Tissue is broken down to small fragments and released into the circulation. Changes in the~     amount of these fragments in the blood may provide information on the damage and quality of~     the affected tissue and may therefore act as objective measure of disease burden and~     severity - a so called biomarker.~      The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal~     survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The~     patients are followed for up to 1 year. Changes in biomarker are correlated to standard~     markers of inflammation during active disease and remission.~      Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut~     of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of~     treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.~   "
33996|NCT02612090|"~     Primary objective is to assess strawberry intake on LDL cholesterol and its association with~     atherosclerosis development.~   "
33997|NCT02612077|"~     This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate~     progression free survival (PFS) in a real-life setting in participants with metastatic~     colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.~   "
33998|NCT02612064|"~     This single centre, dual site, comparative design study will be used to investigate the~     efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal~     hypersensitivity (DH) after short term use~   "
33999|NCT02612051|"~     GSK3008348 is an investigational drug, being developed by GlaxoSmithKline Research and~     Development Limited (the Sponsor, a pharmaceutical company based in the UK) for the~     treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare and poorly understood~     disease that causes scarring of the lungs. The main symptoms are shortness of breath and a~     dry cough. Symptoms generally worsen over time and in some subjects may prove fatal. The~     cause of IPF is unknown.~      This is a First Time in Human, Phase 1, 3-part study which is being carried out on behalf of~     the Sponsor by Quintiles. The primary purpose of Part A is to examine the safety and~     tolerability of single nebulised (a medicated spray) doses of GSK3008348 following~     inhalation in healthy volunteers. The secondary objective is to determine how and at what~     rate the body absorbs, distributes, breaksdown and eliminates the drug.~      Parts B and C of this study will be in-patients with Idiopathic Pulmonary Fibrosis (IPF).~     The purpose of Part B and C is to examine the safety and tolerability, and how much of the~     drug binds to its target, following single nebulised (a medicated spray) doses of GSK3008348~     following inhalation in patients with Idiopathic Pulmonary Fibrosis (IPF). The secondary~     objective is to determine how and at what rate the bodies of these patients absorbs,~     distributes, breaksdown and eliminates the drug.~      The total duration of Part A will be 65 - 87 days, Part B 62 days and Part C 43 days.~   "
34000|NCT02612038|"~     Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled~     intervention study, the investigators seek to determine whether applying expiratory~     resistance can acutely improve ventilation and sleep in patients with expiratory flow~     limitation (EFL).~   "
34001|NCT02612025|"~     The purpose of this study is to determine whether combined endurance and resistance training~     can improve muscle strength in children and adolescents with cancer during the intensive~     treatment phase.~   "
34002|NCT02612012|"~     This study is designed to evaluate the feasibility and safety of axillary radiotherapy for~     early stage breast cancer with limited positive sentinel lymph nodes.~   "
34003|NCT02611999|"~     The investigators' study seeks to explore the impact of price information on physicians'~     ordering behavior and care quality. The investigators will evaluate the impact of the~     physician price transparency initiative at Atrius Health (ATRIUS) on rate of overall~     procedure and test orders, clinically inappropriate orders, and appropriate orders.~     Ultimately, this study will help stakeholders understand the degree to which price~     information can help improve the value of healthcare.~   "
34004|NCT02611986|"~     A randomized controlled prospective study of laryngoscopy and intubation success comparing~     direct laryngoscopy and the McGrath® Mac videolaryngoscope.~   "
34005|NCT02611973|"~     The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes~     less useful once patients have achieved a complete hematologic response (CHR) and/or that~     this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.~      Hence, investigator propose a prospective randomized study to assess the benefit / risk~     ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in~     complete hematological response on Hydroxyurea.~   "
34103|NCT02610673|"~     This is an observational, prospective, non-randomized collection of defined clinical data~     under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system~     capable of delivering pacing energy to the left ventricle of the heart without using a~     pacing lead.~      Patients will be enrolled and followed according to standard of care for 5 years.~   "
34006|NCT02611960|"~     This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment~     (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic~     nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either~     pembrolizumab or Investigator's choice of standard treatment.~      The primary study hypothesis is that pembrolizumab treatment prolongs progression-free~     survival (PFS) and overall survival (OS) when compared to SOC treatment.~   "
34007|NCT02611947|"~     Various indexes have been proposed to quantify both pulmonary emphysema and airways disease~     on chest CT scans. It is unknown whether these indexes should be consider in absolute values~     or as compared to predicted normal values. The purposes of the present study is thus : a) to~     measure these indexes at CT in healthy volunteers; b) to investigate their relations with~     gender, height and weight.~   "
34008|NCT02611934|"~     Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest~     Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine~     whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes~     (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated~     with better clinical outcomes as compared with therapy without MTH.~   "
34009|NCT02611921|"~     The purpose of the study is to determine if intranasal ketamine shows initial evidence of~     safety, tolerability and efficacy for the treatment of social impairment in individuals with~     Autism Spectrum Disorder.~   "
34010|NCT02611908|"~     The purpose of the study is to investigate whether the combination of obinutuzumab and~     ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or~     SLL that is not responding or no longer responding to treatment with ibrutinib alone. The~     study will evaluate whether this regimen can reduce the amount of cancerous cells in the~     body. Subjects will be treated with ibrutinib at a dose of up to 840 mg a day by mouth, as~     well as obinutuzumab infusions. Although both of these agents are approved by the FDA for~     the treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are~     considered experimental.~   "
34011|NCT02611895|"~     There is a theoretical possibility of a complete suppression of HIV viral replication,~     subject to the use of highly active associations of more than 25 antiretroviral drugs~     currently available and good treatment adherence. But a key question remains: whether it can~     persist viral replication low noise HAART, since several arguments suggest a subclinical~     escape of the virus to HAART at least in some individuals. The technique proposed in this~     research consists of the detection and quantification of the linear viral cDNA intra~     cytoplasmic, as persistent novo infection marker in order to highlight the subclinical~     replication active in treatment of HIV-1 and consider an optimized therapeutic management of~     patients.~      Main objective : Comparing the frequency of patients infected with HIV and treated~     effectively (HIV viral load undetectable plasma with conventional methods) having the HIV~     DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection~     marker novo persistent, among patients with a therapeutic regimen contains or not the viral~     integrase inhibitor raltegravir.~      Secondary objectives~        -  To evaluate the frequency of patients infected with HIV and treated effectively with~          the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood~        -  Evaluate the causes of persistent infection in de novo virological responders to~          treatment with ART: presence of the HIV genome encoding strains resistant to treatment~          ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir ,~          pretreatment level of plasma HIV RNA, total duration of ART~        -  Assess the impact of persistent novo infection virological responders: cell activation~          CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio~          T naïve / memory cells cells, the presence of transient increase viremia, residual~          viremia levels~        -  Identify virological responders may benefit from treatment intensification~   "
34012|NCT02611882|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in~     patients with high risk disease prior to prostatectomy, patients with biochemical recurrence~     and patients with castrate resistant prostate cancer.~   "
34013|NCT02611869|"~     120 consecutive patients with paroxysmal AF, slated for PV isolation, will be randomly~     assigned to RF or cryoballoon ablation (in a 1:2 allocation scheme). Real-time 3D~     echocardiography (RT3DE) will be performed before the ablation procedure and 1 month~     post-ablation. The RT3DE datasets will be stored digitally and quantitative analyses will be~     performed off-line at a core echo laboratory. Quantification of left atrial volumes will be~     performed and left atrial functional quantification will be performed by calculating the~     following indices: Left atrial ejection fraction, Active atrial emptying fraction, Passive~     atrial emptying fraction, Atrial expansion index. All patients will be hospitalized for 48~     hours post-ablation. Blood samples will be obtained at 12-hour intervals to measure troponin~     T with a high-sensitivity assay, as well as other biochemical parameters.~   "
34014|NCT02611856|"~     The twin pregnancies monochorionic are specifically explained to two main types of~     complications: the anomalies of the embryo affecting a symmetry and in particular the median~     line on one hand and malformative sequences of vascular origin on the other hand. This last~     category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a~     division of the foeto-placentary circulation between both twins through the pooling of~     certain placentary cotyledons. The latter are then vascularized by an arterial and venous~     foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results~     from it an imbalance moderate but very early hemodynamic which is going to return a~     hypovolume twin (the donor) and its plethoric co-twin (the recipient).~      These anomalies in utero could not only have consequences during the fetal life, on the born~     weight and the later development of newborns, but also on the organization and the~     functioning of a whole series of physiological systems. So these anomalies of the pregnancy~     could have also consequences which exceed by very far from the perinatal period, by favoring~     the development of the atheroma, the high blood pressure, the resistance in the insulin, and~     many other metabolic and endocrine functions were known for their importance in human~     pathology.~      For these reasons the investigators suggest estimating the tensional, cardiac and metabolic~     status of children ex-transfusers and of children ex-transfused into the age of 5 years.~     This if study leans on the big originality of the physiopathological model of TTTS in which~     the children present the peculiarity to have an identical genetic and postnatal status and a~     different prenatal environment.~      The follow-up of these children should allow:~        -  To understand better the postnatal impact anomalies on these children in the course of~          pregnancy~        -  To anticipate and thus to improve their care in case of appearance of biological or~          clinical signs~   "
34025|NCT02611713|"~     This study is a non-interventional post-marketing observational study (PMOS) of participants~     with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical~     setting. Effectiveness of treatment will be collected with physician and~     participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at~     the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal~     extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6~     months thereafter up to 36 months.~   "
34026|NCT02611700|"~     This clinical study is designed as a phase 3,multicenter, double-blind, randomized,~     controlled study,to evaluate the efficacy and safety of nimotuzumab combined with~     paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic~     esophageal squamous carcinoma.~   "
34027|NCT02611687|"~     The purpose of this multicenter double blind study is to assess efficacy and safety of~     Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.~   "
34015|NCT02611843|"~     Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and~     hazardous substance use (HSU). Evidence-based treatments for these problems are available in~     VA specialty clinics, but multiple barriers lead to low utilization of these treatments.~     Novel treatment approaches are needed. Previous research supports that 1) primary~     care-mental health integration (PC-MHI) services are associated with increased treatment~     engagement, 2) technology-based interventions are well accepted by Veterans and are more~     effective when delivered with professional support, and 3) Veteran peer services are~     associated with improved treatment engagement, patient motivation, and overall functioning.~     This study will add a Peer-Support component to an existing Web-based Cognitive Behavioral~     Treatment (CBT) for PTSD and HSU called Moving Forward. Preliminary data analyses from our~     NIAAA-funded trial indicate that participants who used Moving Forward more had larger~     reductions in PTSD symptoms. Qualitative feedback supports that Veterans want interpersonal~     interactions while receiving treatment and need help engaging in the treatment more fully.~     Therefore, this pilot study will investigate if adding peer support to Moving Forward~     improves patients outcomes. A randomized controlled trial (N=30) comparing Moving Forward to~     Peer-Supported Moving Forward will be conducted. The peer support component will consist of~     semi-structured brief sessions conducted weekly for the 12 weeks of study treatment by a~     VA-certified peer support specialist. Peers will receive study-specific training and weekly~     supervision from clinicians that are part of the study staff. Primary outcomes will include~     process outcomes (treatment engagement, patient satisfaction) and clinical outcomes (PTSD~     symptoms, alcohol and substance use, quality of life).~   "
34016|NCT02611830|"~     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab~     SC) maintenance treatment in participants with moderately to severely active ulcerative~     colitis (UC) who achieved clinical response following administration of vedolizumab~     intravenous (vedolizumab IV) induction therapy.~   "
34017|NCT02611817|"~     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab~     SC) as maintenance treatment in participants with moderately to severely active Crohn's~     disease (CD) who achieved clinical response following administration of vedolizumab~     intravenous (vedolizumab IV) induction therapy.~   "
34018|NCT02611804|"~     To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test~     product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the~     clinical equivalence and to show that the efficacy of the 2 active formulations is superior~     to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald~     scalp.~   "
34019|NCT02611791|"~     OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative~     radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the~     sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29~     sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the~     study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF~     once a week. The instruments of evaluation were photo (taken before the first session and~     eight days after the last session), which were evaluated by the patient and by three health~     professional (that did not know the group); by the 3 points Likert scale (unsatisfied,~     unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by~     the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of~     Student. The patients' satisfaction and the health professionals' evaluation were analyzed~     by the chi-squared test and by binomial comparison inter-group and intra-group.~   "
34020|NCT02611778|"~     The purpose of this study is to determine the efficacy and safety of the biosimilar~     ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related~     macular degeneration.~   "
34021|NCT02611765|"~     Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new~     cases per year. Due to shared transmission route and risk factors, co-infection with~     syphilis and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have~     evaluated the response to syphilis treatment in HIV-infected patients. They support the~     claim that patients with HIV have a slower decrease in syphilis antibody titers, and that~     they may progress to neurosyphilis in earlier stages.~      The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment~     Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis~     or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients~     (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a~     randomized controlled trial in order to compare the efficacy of three- versus single-dosed~     regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis~     in HIV-infected patients.~   "
34022|NCT02611752|"~     Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and~     duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in~     patients with moderate or severe opioid use disorder.~   "
34023|NCT02611739|"~     Pain is a frequent and significant problem related to cancer-directed treatment in children.~     Children with cancer often cite needle procedures as the most distressing experience caused~     by cancer and its treatment. Recently it has been shown that an interactive humanoid robot~     is capable of facilitating distraction and reducing distress during childhood immunizations.~     Our research objectives are to: (1) assess the feasibility of implementing the robot~     (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes)~     and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness~     outcomes), compared to standard medical care.~   "
34024|NCT02611726|"~     Rationale for conducting the experiment: Israel performed IVF treatments since 1980.~      Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and~     pregnancy rates have not met the expectations yet. Success rates of fertility treatments are~     about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical,~     technological and complimentary) have been tried to improve the CPR.~      In some reviews the effects of acupuncture practice during fertility treatments showed~     certain benefits, including pain relief and relaxation. Unfortunately those trials were not~     randomized and lacked methodological rigor.~      The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of~     women undergoing IVF as compared to standard care alone.~   "
34028|NCT02611674|"~     The primary objectives of the study are to estimate and rank-order the longitudinal~     standardized mean changes over 6 months and over 12 months, for a set of novel outcome~     measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to~     identify measures that are more sensitive to disease progression than Amyotrophic Lateral~     Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study~     are: To evaluate the test-retest reproducibility of each outcome measure; To determine~     correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month~     changes in ALSFRS-R and survival; To assess correlations between/among the various measures;~     To obtain biological samples in order to identify molecular correlates to the clinical~     measures and to further characterize previously identified and novel molecular biomarkers of~     disease progression for incorporation into future clinical studies.~   "
34029|NCT02611661|"~     The rationale for this design is initial utilization of a standard-of-care therapy for mCRC~     (radioembolization) with a dose-calculation algorithm that has been verified as predictive~     for treatment response. Prediction of treatment failure will enable the proposed subsequent~     locoregional therapies which were selected based on safety profiles and feasibility. While~     the goal of this study is assessing feasibility and safety of this approach, the end goal of~     improving overall patient outcomes by improved hepatic tumor control.~   "
34030|NCT02611648|"~     This study is investigating the most effective way to sterilize duodenoscopes (scopes)~     used at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard~     method of high level disinfection to sterilize scopes. Because infections have been passed~     by scopes at other institutions in the U.S., the investigators are exploring whether or not~     adding two different sterilization processes will reduce this risk of contamination.~      Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is~     contaminated, bacteria may be passed from the scope to the patient. In order to understand~     how bacteria are passed, the investigators will be taking samples of the patient's~     intestinal bacteria to compare to the bacteria, if any, found on the scope.~   "
34031|NCT02611635|"~     The main research question of this patient survey is to assess AF patients' preferences~     associated with different attributes which describe the different available anticoagulation~     treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).~      VKA (Waran®) will be compared to Rivaroxaban.~   "
34032|NCT02611622|"~     Patient satisfaction is an important metric currently used to rate quality of healthcare in~     hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to~     any hospital establishment. Recent studies have shown patient satisfaction depends on~     multiple factors, including patient involvement in treatment decision-making processes and~     patients' knowledge of treatment options. Internal review of departmental patient~     satisfaction survey scores revealed deficits in the aforementioned areas of patient~     satisfaction, with the domains of how well concerns were addressed, explanation of tests~     and procedures and effort to include patients in decisions having the lowest scores on~     patient satisfaction surveys. This highlights the gap in patient satisfaction that the~     Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and~     in turn, the quality of healthcare provided.~      The aim of this study is to assess the improvement in patient satisfaction scores that can~     be obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education~     software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient~     education software that provides visual anatomic animations of disease processes, disease~     progression and treatment options to improve patients' knowledge. Thyroid disorders have~     been chosen for study due to their high frequency of occurrence in the patient population~     and generalizability to a wide medical audience.~      The investigators will perform a single-blinded randomized-controlled study of patients~     visiting the physician practices of the Department of Otolaryngology for management of~     thyroid disorders. Participants will be randomized into control and intervention groups.~     Upon completion of the routine physician-patient clinical encounter, the intervention group~     will view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its~     natural progression history, and treatment options. They will have an opportunity to ask the~     physician any further questions that arise from viewing the video. The control group will~     not view the LUMA ENT video. Patient satisfaction surveys will then be provided to both~     groups at the end of the visit as is routinely done and scores subsequently compared.~   "
34033|NCT02611609|"~     A study to examine the safety (and potential efficacy) of the adult stem cell~     investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome~     (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.~   "
34034|NCT02611596|"~     The purpose of this investigation is to compare subjects at high risk for silent myocardial~     ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the~     ranolazine group to determine if ranolazine can be used as a treatment to decrease silent~     myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined~     in this protocol as diabetics with stable ischemic heart disease. This study will look at~     the impact ranolazine treatment has on biomarkers that have been shown to be highly~     associated with increased risk of morbidity and mortality in relation to SMI. If the~     hypothesis is correct, further studies can be conducted to determine if treatment with~     ranolazine has impact on long-term outcomes such as hospitalizations, myocardial infarction,~     congestive heart failure or sudden cardiac death.~   "
34035|NCT02611583|"~     Patients presenting to the ED with a chief complaint of acute low back pain and whom the~     providing physician feels symptomatic treatment is appropriate in the ED will be screened~     for inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical~     Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain~     in the emergency department. Therefore, the aim of this prospective, randomized, double~     blind study is to evaluate the efficacy of ED administered TENS in acute low back pain~     patients during their ED visit.~   "
34036|NCT02611570|"~     This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early~     lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or~     have high risk exposures to lung cancer will be recruited to participate LDCT screening and~     followed up for their possible occurrence of lung cancer.~   "
34037|NCT02611557|"~     This study will apply novel, noninvasive structural and functional magnetic resonance~     imaging (MRI) methods to patients with mild and moderate breast cancer-related lymphedema~     (BCRL) for the first time to test fundamental hypotheses about relationships between~     lymphatic compromise and imaging biomarkers that may portend disease progression and~     individualized therapy response.~   "
34038|NCT02611544|"~     Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive~     sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated~     at up to 89%, with approximately half of cancer survivors reporting clinically significant~     levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with~     FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our~     long-term goal is to develop, evaluate, and implement effective behavioral interventions for~     cancer survivors suffering with FCR.~   "
34044|NCT02611466|"~     The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to~     placebo.~      This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on~     walking, function and stiffness; the time course of efficacy of ASP7962 relative to placebo;~     the improvement in overall patient status of ASP7962 relative to placebo as well as the~     safety and tolerability of ASP7962 relative to placebo.~   "
34045|NCT02611453|"~     Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic~     retrograde cholangiopancreatography (ERCP) of the biliary tract. While frequently observed~     during routine ERCP, there are few data on the topic of air or CO2 cholangiography. Our~     primary aim is to compare radiographic cholangiograms in patients with biliary tract disease~     (from stones or strictures) during ERCP obtained by using carbon dioxide as the contrast~     medium vs. conventional iodinated contrast.~   "
34046|NCT02611440|"~     Medication adherence is a major factor to prevent vascular recurrence after a first ischemic~     stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are~     needed to improve it.~      A patient - centered and pluriprofessional structured intervention, targeting the~     medication, introduced at hospital discharge and continued at home (by regular telephone~     contact) could improve medication adherence one year after stroke.~      This intervention would consist of semi structured interviews patient-pharmacist at~     different times during one year after stroke. The information about the therapeutic~     management of the patient will be shared between healthcare professionals : general~     practitioners (GP) and community pharmacists (CP), hospital clinical pharmacist (HCP) and~     physician (HPhys).~      It will allow for decrease of the recurrent stroke and others cardiovascular complications~     based on a better adherence to preventive medication. Furthermore the decrease of the~     iatrogenic events and the improvement of the quality of life of patients may be also~     associated.~   "
34047|NCT02611427|"~     After recuperating from low back surgery patients often perpetuate a sedentary lifestyle~     because they are concerned about injury and recurrent pain. The objective of this study is~     to test the feasibility of a program to increase lifestyle walking starting several months~     after low back surgery.~   "
34048|NCT02611414|"~     Functional dyspepsia is a very common disorder of great challenge to clinical management. A~     therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct~     current stimulation (tDCS) is a novel therapy that pursues these properties, besides its~     safety and easy adherence. There is a great need of new treatments for functional dyspepsia.~     There is no current study evaluating tDCS for this disease.~   "
34049|NCT02611401|"~     Multiple Sclerosis has a great impact on psychological functioning of patients and can be~     associated with various psychological disorders and symptoms. The most prevalent one is~     depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a~     relatively brief and cost-effective program that has been studied in patients with several~     diseases.~      Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on~     correlated symptoms of MS patients and their caregivers.~      Methods. The study design is a randomized controlled clinical trial. The subjects of the~     study are 88 patients with MS and depressive symptoms that will be pre-screened from among a~     catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88~     patients will subsequently be randomized into two groups (44 in the experimental group and~     44 in the active control group). The psychological assessment, independent and blind to~     treatment, will be performed with the same timing and tools: at baseline (T0), after~     treatment (T1), and 6 months after the end of the group intervention (T2). The assessment~     will encompass the administration of the clinical interview and other self-report~     questionnaires.~      The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day~     session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol~     integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better~     tailor it on the needs of people with MS suffering from depressive symptoms. The active~     control group is designed to control for the non-specific elements of the MBI treatment and~     will follow the same structure as the MBI. It will be based on a psycho-educational~     framework and will include relaxation techniques.~      Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2~     that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer~     meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the~     improvement of FAMS scores for the six primary aspects of QoL.~   "
34050|NCT02611388|"~     The purpose of this study is to explore the neurohumoral mechanism of deferent frequency~     TEAS pretreatment.~   "
34051|NCT02611375|"~     Non-invasive brain stimulation has gained increasing popularity and research support over~     the past several years. Recent research indicates that it might have benefits for improving~     hand function in people with spinal cord injury. The purpose of this study is to evaluate~     the effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.~   "
34052|NCT02611362|"~     This study will develop and test a novel, smartphone based gaming intervention to improve~     adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to~     decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention,~     participants will engage with an immersive app/game on their iPhone that is connected to~     smart, electronic pill organizer/dispenser. Data on adherence from the pill dispenser will~     be integrated into the app/game wirelessly and will translate into enhancements during game~     play. While gaming, participants will gain information about their health, improve~     motivation for PrEP and medical appointment adherence, and practice healthy behaviors. If~     the intervention is found to be effective, it can be tested in a larger study and then~     disseminated to other people taking PrEP.~   "
34053|NCT02611336|"~     Pathophysiology of acromegaly cardiomyopathy is yet unclear and a specific treatment have~     not been indicated. It was already demonstrated the positive impact of phosphodiesterase~     type 5A (PDE5A) inhibition in several models of cardiomyopathy and in a model of endocrine~     cardiomyopathy due to type 2 diabetes mellitus. In this patients with diabetic~     cardiomyopathy it was demonstrated an improvement in cardiac kinetic, geometry and~     performance parameters and reduction of the ambulatory measurement of waist circumference.~      This represents the first study that evaluate heart remodeling and performance changes and~     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Acromegaly~     cardiomyopathy.~      The proposed research will test whether phosphodiesterase 5A inhibition could become a new~     target for antiremodeling drugs and to discover molecular pathways affected by this class of~     drugs and a network of circulating markers (miRNA) for the early diagnosis of acromegaly~     cardiomyopathy.~      We hypothesize that:~        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers~          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,~          activating cGMP signaling pathways, could improve cardiac remodeling due to acromegaly~        -  PDE5 inhibition could have a role in lipolytic regulation;~        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.~          MCP-1, TGF-ß) might relate with left ventricular (LV) remodeling in Acromegaly;~        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines~          (e.g. MCP-1, TGF-ß) related to cardiac disease in Acromegaly;~        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with LV~          remodeling in Acromegaly.~   "
34126|NCT02610374|"~     The primary objective is to assess the effect of short-term diet modification on the~     microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy~     (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative~     controls in the United States.~   "
34054|NCT02611323|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment~     with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or~     refractory FL or DLBCL. Participants with FL who achieve complete response (CR), partial~     response (PR), or stable disease (SD) at the end of induction therapy will receive~     post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who~     achieve CR or PR at the end of induction will also be eligible for post-induction treatment.~   "
34055|NCT02611310|"~     This is a prospective, national, multicenter, non-interventional study designed to enroll~     participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior~     to registry enrollment. These participants will be prospectively followed for at least 5~     years after study enrollment to evaluate their anti-cancer treatments. Data on participants'~     previous anti-cancer treatments for breast cancer will be collected retrospectively at study~     entry.~   "
34056|NCT02611297|"~     The purpose of this study is to evaluate the the diagnostic yield and safety of~     transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.~   "
34057|NCT02611284|"~     The aim of this study is to assess the efficacy and feasibility of a new less invasive~     surfactant administration (LISA) technique with a specific designed cannula for surfactant~     administration using Beractant replacement in preterm infants <32 weeks of gestation and~     compare short and long term outcomes with the intubation, administration of surfactant and~     extubation method (INSURE).~      This was a single-center, prospective, open-label, non-randomized, controlled study with an~     experimental cohort of 30 patients treated with LISA and a retrospective control group~     comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was~     administered as exogenous surfactant in both groups if patients on nasal continuous positive~     airway pressure (nCPAP) during the first three days of life were needed of more than 30% of~     fraction of inspired oxygen inspired oxygen fraction (FiO2).~   "
34058|NCT02611271|"~     Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the~     levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The~     adsorber is frequently used in series with continuous renal replacement therapy. Up to date,~     no data on the removal of antibiotic drugs during combined renal replacement therapy and~     cytokine adsorptive therapy is available. Therefore, we want to investigate~      - whether and to what extent antibiotic drugs (piperacillin/tazobactam and~     imipenem/cilastatin) are removed during combined continuous renal replacement therapy and~     cytosorb adsorption in patients with severe sepsis and septic shock~   "
34059|NCT02611258|"~     Pathophysiology of Cushing's Syndrome (CS) cardiomyopathy is yet unclear and a specific~     treatment have not been indicated. It was already demonstrated the positive impact of~     phosphodiesterase type 5A (PDE5A) inhibition in several models of cardiomyopathy and in a~     model of endocrine cardiomyopathy due to type 2 diabetes mellitus. In this patients with~     diabetic cardiomyopathy it was demonstrated an improvement in cardiac kinetic, geometry and~     performance parameters and reduction of the ambulatory measurement of waist circumference.~      This represents the first study that evaluate heart remodeling and performance changes and~     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Cushing's~     Syndrome cardiomyopathy. The proposed research will test whether phosphodiesterase 5A~     inhibition could become a new target for anti-remodeling drugs and to discover molecular~     pathways affected by this class of drugs and a network of circulating markers (miRNA) for~     the early diagnosis of Cushing's Syndrome cardiomyopathy.~      The investigators hypothesize that:~        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers~          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,~          activating cGMP signaling pathways, could improve cardiac remodeling due to CS;~        -  PDE5 inhibition could have a role in lipolytic regulation;~        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.~          MCP-1, TGF-ß) might relate with left ventricular remodeling in CS;~        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines~          (e.g. MCP-1, TGF-ß) related to cardiac disease in CS;~        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with~          left ventricular remodeling in CS;~   "
34060|NCT02611245|"~     This study aims to first apply near-infrared fluorescence imaging technology in thoracic~     surgery with indocyanine green in China. To evaluate the feasibility usage of the~     investigators' fluorescence imaging systems and the safety applications in intraoperative~     sentinel lymph node mapping of lung and esophageal cancer, lung nodule imaging, lung segment~     resection boundary determination, esophagus - tubular anastomosis, thoracic duct imaging and~     chylothorax repairing thoracic surgery. Aim to achieve precise boundaries definition during~     thoracic surgery and realize accurate, minimally invasive thoracic surgery with fluorescence~     imaging technology.~   "
34061|NCT02611232|"~     The main objectives of the trial are to study whether daily treatment with liraglutide~     improves insulin secretion and glucose metabolism, and whether liraglutide treatment is~     tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.~   "
34062|NCT02611219|"~     The purpose of this feasibility study is to test the potential for successful implementation~     of an intervention designed to study the effect of six hours out of bed time on the overall~     level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research~     has demonstrated that deconditioning occurs rapidly over the course of the hospitalization~     post-transplant and can negatively impact quality of life. By encouraging patients to be out~     of bed for six hours each day, it is anticipated that patients will experience less~     deconditioning than those patients who previously had no established minimum time out of the~     bed.~   "
34063|NCT02611206|"~     This study will be an open-label 6-week (30 session) trial of active repetitive transcranial~     magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation~     intensities using a 3+3 study design for safety and tolerability amongst adolescents. This~     means that we will only enroll 3 participants at a time and give them rTMS at the~     stimulation intensity energy of 80% of motor threshold (MT). If all three participants~     complete the 6 weeks of treatment with no major safety events (i.e. seizure), we will~     increase the energy for the next 3 participants by 5%. If 1 of the 3 participants has a~     major safety event, we will enroll 3 more patients at the SAME energy. We will proceed in~     this manner, increasing by 5% after 3 subjects safely complete treatment at that energy, to~     a maximum energy of 120% of motor threshold. If 2 participants in each intensity level~     cohort experience a major safety event, we will discontinue running subjects at that energy~     level. If this happens at our initial energy level of 80% of MT, we will stop the study. If~     we reach 2 events in any of the higher energy cohorts, we will return to the previous energy~     level and complete the remainder of the subjects at that energy level.~   "
34064|NCT02611193|"~     Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and~     then be utilized as a cheap conservative management of CTS. Study design: Two-groups~     randomized single-blind interventional study.~   "
34065|NCT02611180|"~     Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign~     compounds (antigens) in the body, which they internalize and process. When DCs uptake~     foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens~     are presented to T cells.~      Various DC subsets with unique cell lineages, surface protein markers, and tissue~     localization determinants have been identified. For example, Langerhans cells (LCs) and~     interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the~     skin. Though both are expressed in the skin, they differ with respect to their origin and~     surface protein content and can activate distinct types of immune responses. They may also~     have different specificities for the capture of antigens and presentation to circulating T~     cells.~      To date, it is unknown what role, if any, the different DC populations that reside or~     repopulate in the skin play in the development and progression of skin graft-versus-host~     disease (GVHD) following bone marrow transplant.~   "
34066|NCT02611167|"~     The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous~     allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic~     Parkinson's disease (iPD).~   "
34067|NCT02611154|"~     Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic~     profile during anti-doping testing, which is different than the profile seen when~     testosterone is administered into muscle, on skin or under the tongue.~      Objective: The investigators aim to characterize the unique steroid doping profile following~     administration of intranasal testosterone to healthy, active volunteer subjects.~   "
34068|NCT02611141|"~     Retromolar Intubation is a successful option for intubation in patients with an existing~     retromolar gap in the case that the conventional method fails.~      Therefore the investigators want to test if the retromolar gap is essential for performing~     the retromolar intubation technique.~   "
34069|NCT02611128|"~     Polycystic ovary syndrome (PCOS) is a common disorder marked by hyperandrogenism,~     oligo-/anovulation, and subfertility. The precise causes of PCOS are unclear, but the~     pathophysiology involves complex genetic and environmental influences. Importantly, not all~     girls with obesity have HA, and free testosterone (T) concentrations are highly variable in~     this group. Luteinizing hormone (LH) and insulin concentrations are significant but only~     partial predictors of free T in girls with obesity; significant unexplained variability in~     free T suggests that additional factors contribute to HA in this population. Abnormalities~     of ovarian and adrenal steroidogenesis are likely contributors in this regard, but such~     abnormalities are difficult to quantify. Recent Genome Wide Association Studies have~     identified DENND1A as a PCOS susceptibility gene candidate. Preliminary in vitro data~     strongly implicate a DENND1A splice variant called DENND1A Variant 2 (DENND1A.V2) as a~     contributor to excessive theca cell androgen production in PCOS. The investigators' primary~     goal with the proposed pilot study is to determine the relationship between urinary exosomal~     DENND1A.V2 mRNA and free T concentrations in peripubertal girls. The investigators~     hypothesize that urinary exosomal DENND1A.V2 mRNA quantity is a significant and independent~     predictor of peripubertal hyperandrogenemia. In this study, the investigators will carefully~     phenotype peripubertal girls with and without hyperandrogenemia (primarily in the form of~     hormonal, maturational, and anthropometric measurements) in addition to measuring urinary~     exosomal DENND1A.V2 mRNA. As a primary analysis, the investigators will examine the~     relationship between morning free testosterone and urinary exosomal DENND1A.V2, controlling~     for previously-described partial predictors of free testosterone (LH, insulin) in addition~     to potential confounders (BMI z-score, bone age). These studies will provide important~     information regarding the etiology of HA in peripubertal girls. Ultimately, these data may~     lead to a non-invasive test of ovarian/adrenal steroidogenic activity and support the~     development of a diagnostic test for PCOS in high-risk peripubertal girls (e.g., those with~     obesity).~   "
34070|NCT02611115|"~     Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the~     diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus~     is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory~     distress, acute right cardiac failure or death. Therefore early and correct diagnosis is~     crucial.~      The diagnostic and clinical value of CTPA has already been firmly substantiated.~     Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due~     to insufficient contrast enhancement in the target arteries.~      Therefore future research should focus on two important aspects of CT imaging. On the one~     hand optimal enhancement for the individual patient, on the other hand preventing additional~     risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the~     purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube~     current) and CM application for the individual patient in CTPA.~   "
34071|NCT02611102|"~     Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA~     (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination~     added to coffee. The study will be conducted as a RCT in healthy adults without~     cardiometabolic disease or conditions that influence lipoprotein metabolism or other~     specific dietary recommendations.~   "
34072|NCT02611089|"~     The objective of this work is to understand how the disruption of the muscle connective~     tissue contributes to the limb soft-tissue defects in radial dysplasia. In parallel, the~     researchers will investigate the role of muscle connective tissue in normal limb~     development.~   "
34073|NCT02611076|"~     The purpose of this study is to develop and test a series of culturally relevant and~     appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and~     remaining smoke-free.~   "
34074|NCT02611063|"~     The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated~     B cells will be effective in preventing chronic graft vs host disease (cGVHD) after~     allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD.~     Inhibiting the B cell activation using fostamatinib after allogeneic stem cell transplant~     may prevent the development of cGVHD.~   "
34075|NCT02611050|"~     This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery~     Disease Option Grid patient decision aid compared to usual care in patient reported~     decisional conflict, knowledge, and shared decision making.~   "
34076|NCT02611037|"~     The purpose of this study is to determine whether the transarterial chemoperfusion treatment~     with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant~     pleural mesothelioma (MPM).~   "
34077|NCT02611024|"~     Prospective, open-label, dose-ranging, uncontrolled phase I study with PM01183 in~     combination with irinotecan to determine the maximum tolerated dose (MTD) and the~     recommended dose (RD) of PM01183 in combination with irinotecan in patients with selected~     advanced solid tumors.~   "
34078|NCT02611011|"~     To determine if pregnant women can understand the instructions, carry out the test, and~     interpret the test results regarding the need for follow-up or treatment women will be~     recruited to complete a test instruction and comprehension assessment and a usability~     assessment.~   "
34079|NCT02610985|"~     Background:~      No randomised trials have been conducted, and only a single retrospective study exists~     comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for~     hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy.~     Complication rates were similar for the two groups. Thus, although one out of nine women is~     hysterectomized and although laparoscopy is one of the recommended routes of surgery,~     evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.~      Objective:~      To compare pain and recurrence to usual activity level. Secondary to compare complications~     during the operation, postoperative complications, time to return to work, length of~     hospital stay and operative time.~      Design:~      Investigator-initiated, blinded, randomised controlled trial.~      Intervention description:~      Operative procedures follow the same principles and the same standard whether the surgeon's~     vision is 2D or 3D.~      Trial size Roskilde/Herlev Hospital, Denmark:~      200 patients in each arm of the study.~   "
34080|NCT02610972|"~     A case-control study will evaluate the clinical utility of the CRD test in following women~     with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum~     period in Mexico City.~   "
34081|NCT02610959|"~     The overall aim of the present project is to investigate if intake of cod in pregnancy has~     impact on infant development up to 12 month. 142 pregnant women will be allocated into two~     groups, one counsuming cod two times the week for four months and one group will continue to~     follow their habitual diet. To study this, urine samples, dietary data and blood samples~     from the mother and from the infant, as well as data on neurodevelopment and cognitive~     functioning will be collected at several time points.~   "
34082|NCT02610946|"~     The purpose of this study is to empower adolescent renal transplant recipients to fully~     understand their medical condition as well as to help them acquire the skills to maintain a~     healthy allograft well into adulthood. It is hoped that introducing technological~     applications (apps) will assist adolescents in managing medications, clinic appointments,~     lab appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise~     frequency. The investigators aim to improve adolescent post-renal transplant outcomes~     (increase medication adherence, lower clinic and laboratory no-show rate, lower blood~     pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of~     allograft rejection, decrease hospitalizations) as well as reduce cost.~   "
34083|NCT02610933|"~     This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation,~     who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a~     vitamin K antagonist.~      The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able~     to slow progression of vascular calcification. The second question is whether addition of~     vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular~     calcification.~   "
34084|NCT02610920|"~     This study evaluates a new method of testing the lymph nodes in the armpit of patients with~     breast cancer for tumor involvement. All participants involved in this study will undergo an~     injection of a small amount of iron dissolved in liquid followed by an ultrasound of the~     axilla that will make previously invisible lymph nodes visible, allowing them to be sampled~     in an outpatient setting.~   "
34085|NCT02610907|"~     The study investigates the impact real output (subjects own) and simulated output have on~     the adhesion of adhesives.~   "
34086|NCT02610894|"~     The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH)~     tailored self-management program delivered via mobile technology (a mobile app) after~     discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain,~     nausea and vomiting, fatigue, sore throat, constipation, sleep dysfunction); 2) enhanced~     patient satisfaction, perceived self-efficacy, and quality of life; 3) lower healthcare~     resource use (patient to healthcare provider calls; unscheduled patient appointments with~     healthcare providers; and hospital readmission and emergency department use). A secondary~     objective is to assess how easy the mobile app was to use after orthopaedic ambulatory~     surgery.~   "
34087|NCT02610881|"~     This study seeks to assess the acceptability, compliance, and preference for iron~     supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study~     seeks to assess front line health worker perceptions and experiences regarding ease of~     implementation of each strategy and delivery strategy preference.~   "
34088|NCT02610868|"~     Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses~     of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.~   "
34089|NCT02610855|"~     This study will explore the relationship between skeletal muscle and physical activity in~     scoliosis patients to provide insight into both the etiology of scoliosis and potential ways~     to mitigate the potential harms of treatment.~   "
34090|NCT02610842|"~     Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to~     apply a home based hand care guide in patients with SS and to evaluate its response~     regarding hand pain, function, strength and mobility.~   "
34091|NCT02610829|"~     To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each~     separated by 12 hours.~   "
34092|NCT02610816|"~     The purpose of this interventional study is to test and compare the effectiveness of two~     elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination~     diet (4FED, milk, egg, wheat, and soy). The study will also test the effectiveness of~     swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was~     not effective.~   "
34093|NCT02610803|"~     The purpose of this study is to estimate the clinical relevance of monitoring patients with~     acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the~     presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation.~     Furthermore to evaluate the prognostic significance of brief runs of premature atrial~     complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic~     attack and death.~   "
34127|NCT02610361|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-283 in patients with solid tumours.~   "
34128|NCT02610348|"~     Primary Objective:~      To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a~     three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or~     Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.~   "
34094|NCT02610790|"~     The aim of this study is to quantify pre- and postoperative physical activity of patients~     operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be~     recorded from 15 days before surgery to the end of hospitalization after surgery in a~     prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the~     investigators will propose physical activity thresholds (adapted to the age, gender and~     patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After~     Surgery). Thus, this analysis will allow the investigators to provide patients with physical~     rehabilitation programs a la carte during a hospitalization for colorectal surgery.~     Connected bracelets will directly involve patients in their care and rehabilitation.~   "
34095|NCT02610777|"~     The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus~     azacitidine versus single-agent azacitidine in participants with higher-risk myelodysplastic~     syndromes, chronic myelomonocytic leukemia and low-blast acute myelogenous leukemia.~   "
34096|NCT02610764|"~     To investigate the feasibility of evaluation of prevalence and clinical significance and~     relevance of circulating tumor cells (CTC) in the blood of patients with resectable~     adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The~     primary hypothesis is that the number of CTC correlates with tumor burden and response to~     treatment. One established and one experimental CTC detection platform will be investigated.~     Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant~     treatment (time point 1), after neoadjuvant treatment & before operation (time point 2) and~     after the operation (time point 3). Results will be compared with healthy controls (one time~     point) and correlated with conventional response to treatment evaluation. The persistent~     presence of CTC could be a marker for worse response to treatment and predict early~     recurrence.~   "
34097|NCT02610751|"~     -  The investigators hope their study will answer the question of whether or not fetal~          testosterone levels are increased in female newborns exposed to nicotine as a result of~          maternal smoking during pregnancy. Secondarily they plan to also evaluate maternal~          cotinine and testosterone levels and newborn anogenital distance, second digit to~          fourth digit (2D:4D) finger length ratio, newborn length and birth weight.~        -  The investigators hope by performing this study, they will help to uncover the effect~          of tobacco exposure in utero on human female fetal testosterone levels, thus improving~          the counseling for tobacco use in pregnancy.~   "
34098|NCT02610738|"~     The aim of this study is to develop educational packages for children of primary school age~     with type 1 diabetes and their parents, and to undertake a small scale feasibility study to~     allow evaluation of the curriculum. Paediatric diabetes teams in the United Kingdom~     currently deliver education using largely unevaluated teaching materials. By working with~     the education profession the investigators aim to develop packages which are based on~     recognised educational theory and practice. The investigators hope that use of these will~     result in better blood glucose control, reducing the risk of longterm diabetes complications~     such as eye and kidney disease.~   "
34099|NCT02610725|"~     We are seeking to understand the acceptability of an online yoga class for individuals with~     mood disorders. MoodNetwork members who are 18 years old or over who have experienced~     depression, mania, or hypomania are invited to participate. About 200 MoodNetwork~     participants will take part in this study.~   "
34100|NCT02610712|"~     The purpose of this study is to determine the efficacy of the use of intravenous low-dose~     ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in~     Glutamate neurotransmission and inflammatory serum markers.~   "
34101|NCT02610699|"~     Ear infections, or otitis media, are a leading cause of health expenditures and~     antimicrobial prescriptions in children. Diagnosis of otitis media requires the ability to~     view the tympanic membrane. An instrument called an otoscope with a light source and a~     magnifying lens with a plastic tip that conforms to the ear canal is currently the standard~     of care for examining the tympanic membrane. Interpretation of otoscopic examinations is~     operator-dependent and cannot be seen by anyone other than the person holding the otoscope.~     A pocket size attachment that uses the technology and light source of a smartphone to~     capture images of the ear canal and tympanic membrane facilitates image documentation of the~     otic examination. In previous studies with the device, the investigators have shown that~     image quality of photographs of the tympanic membrane taken with the smartphone otoscope are~     equivalent to those taken with a camera-fitted conventional otoscope.~      In this study, the Community Provider Assessment Study (CPAS), the investigators will~     perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use~     a smartphone otoscope as the standard of care device for all ear examinations and 3-4~     pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months.~     The parents of children examined during the study period with both devices will be invited~     to participate in 3 telephone surveys assessing parental satisfaction with the device and~     antimicrobial use by their child for the otic complaint. The results of this study have the~     potential to improve diagnosis and management of otitis media, thus improving patient care,~     reducing costs, and decreasing the opportunity for the development of antimicrobial~     resistance.~   "
34102|NCT02610686|"~     Understanding the extent and regional distribution of CQR vivax malaria and detecting early~     signs of resistance is critical to prevent the spread of resistant strains, optimize~     treatment guidelines, and reduce the risk of recurrent and severe malaria. In Vietnam, CQR~     in P.vivax has been reported sporadically. One study carried out in Binh Thuan province~     (central-south Vietnam) at the end of the 1990s demonstrated early P.vivax recurrences (7%)~     by Day 16 after a 3-day CQ treatment. However, in a summary report to World Health~     Organization (WHO) including data from 11 sentinel sites, from studies conducted between~     2006 and 2011 in central and southern Vietnam (total 350 patients), P.vivax is still~     considered sensitive to CQ. More recently in a cohort study conducted in Quang Nam province~     (Central Vietnam) in which P.vivax patients were treated radically with CQ and primaquine~     (10-day at 0.5mg/kg/day) following national guidelines, the 28-day failure rate was measured~     at 3.45% and CQ blood concentrations measured at day of recurrence (>100ng/ml) confirmed~     resistance in three patients. The current national guidelines for the radical cure regimen~     of P.vivax infections recommends 3 days of CQ (total 25 mg/kg body weight (bw)) together~     with 14 days of primaquine at 0.25 mg/kg bw/ day.~      The current WHO protocol recommends a 28-day follow-up to assess the efficacy of CQ for the~     treatment of P.vivax infections. However, recurrence of early stage resistant parasites may~     occur after Day 28 in the presence of CQ blood levels above the minimum efficacy~     concentration (MEC, ≥100ng/ml) and relapses could occur as early as 36 days after standard~     CQ treatment. Therefore, in order to confirm CQR it is recommended to extend the follow-up~     period, to Day 42 or 63 and measure whole blood CQ level at Day 28 and at the time of~     recurrence. Moreover, it has been shown that emerging drug resistance in P.vivax is~     associated with delayed parasite clearance after treatment, i.e. some parasites are still~     detectable at Day 3. The aim of the present study is to assess the in vivo and ex vivo~     susceptibility of P.vivax to CQ in Central Vietnam following the currently recommended~     radical cure regimen and using GMP certified CQ.~   "
34104|NCT02610660|"~     The TOPP-2 registry is an international, non-interventional, prospective registry including~     children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further~     insights in the disease course and long-term outcome of PH in childhood.~      Patients will undergo clinical assessments and receive standard medical care, as determined~     by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically~     designed to capture the variables that have been proposed as treatment goals in PePH and the~     reasons for changes in treatment strategy.~      The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World~     Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations~     for children with PH.~      The registry is planned and implemented under the scientific leadership of the Association~     for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.~   "
34105|NCT02610647|"~     The main objective of this study is to compare between groups the level of complexity of the~     estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.~   "
34106|NCT02610634|"~     Parkinson's disease (PD) is associated with problems of gait such as veering, difficulty~     turning, an inability to perceive doorways or obstacles, and negotiate uneven terrain. Gait~     problems, especially veering, may be exacerbated by visuospatial dysfunction which~     predispose to falls, freezing and festination of gait. Visuospatial dysfunction is common in~     PD and likely involves peripheral features (e.g. contrast sensitivity) as well as central~     cognitive mechanisms (e.g. attention).~      Central neuro-degeneration in PD, PD dementia, and dementia with Lewy Bodies may influence~     visual function, as impaired visual sampling has been reported in these conditions. Visual~     sampling is measured via saccadic (fast eye movement) activity, as saccades are the~     mechanisms through which people orientate and explore the environment. The use of objective~     devices to reliably measure saccades is important to detect disease related eye movement~     changes. Emerging visuomotor research has measured visual sampling in PD using devices such~     as electrooculography and infra-red eye tracking, revealing reduced amplitude, speed and~     frequency of saccades during various tasks.~      Despite recent increases in visuomotor research it remains unclear how PD influences visual~     sampling of the environment during gait and the influence of attentional and cognitive~     deficits. Recent work demonstrated that people with PD sample their environment less~     frequently than controls, despite a slower gait. Saccadic timing was unchanged in response~     to environmental cues. Despite this, environmental visual cues (transverse lines on the~     floor) have been shown to increase the number of fixations made during gait. However the~     mechanisms of this response remain unclear. Cognition is likely of importance, with response~     potentially influenced by attentional control.~      This observational study aims to examine the influence of cognition on visuomotor control~     during gait in PD. This aim will be achieved by observation of visual sampling under several~     environmental challenges (straight walk, doorways, turns, visual cue) and a dual task.~   "
34107|NCT02610621|"~     Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or~     T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo~     standard of care lumpectomy without sentinel node biopsy and whole breast radiation,~     followed by chemotherapy.~      Sentinel node biopsy is also considered standard care when patients have localized breast~     cancer. Treatment can often be influenced by whether the results of the biopsy show cancer~     or not. However, the biologic factors of the primary tumor have become more important in~     determining treatment recommendations in women with clinically node negative breast cancer.~   "
34108|NCT02610608|"~     This study aims at evaluating clincal practice regarding prevention of arterial and venous~     thrombosis following ovarian stimulation.~      Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and~     venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the~     incidence and risk factors for ovarian hyperstimulation syndrome in these women~   "
34109|NCT02610595|"~     To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug~     resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.~   "
34110|NCT02610582|"~     The purpose of this study is to proof the safety and efficacy of a single subretinal~     injection of rAAV.hCNGA3 in patients with CNGA3-linked achromatopsia.~   "
34111|NCT02610569|"~     Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The~     therapeutic objective, which was originally based on clinical remission, is currently~     evolving with the development of biotherapies towards the achievement of endoscopic~     remission. Current recommendations for therapeutic management advocate the achievement of~     endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy~     in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a~     digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy~     for a partial exploration of the colon) from endoscopic activity scores adapted for UC.~      Currently, the score the most commonly used is the MAYO endoscopic score. This is a global~     score of increasing intensity from 0 to 3, taking into account the following basic lesions:~     vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion~     and ulceration. However this score has limits: it does not distinguish deep cavitating~     ulcerations with mucous detachment from simple ulcerations which have a better prognosis.~      A new endoscopic score specific for UC has been developed and is currently being validated.~     It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes~     into account the three most reproducible factors - the vascular pattern, the presence of~     bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.~      To ensure optimal patient care and an adaptation of the therapeutic medical care to the~     endoscopic severity of the disease, endoscopic exploration should be performed recurrently.~     However, this exploration is an invasive procedure, requires general anaesthesia for~     colonoscopy, and can lead to potential complications such as perforation. This explains the~     poor acceptance by patients, resulting in a sub-optimal therapeutic support.~   "
34112|NCT02610556|"~     The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and~     cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced~     nasopharyngeal carcinoma.~   "
34113|NCT02610543|"~     This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept~     study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary~     Sjogren's Syndrome (pSS).~      The primary objective of this study is to evaluate the efficacy on overall disease activity~     and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.~   "
34114|NCT02610530|"~     The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety)~     participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus~     (T2DM) will be evaluated for the efficacy of surgical intervention in comparison with~     medical treatment. Primary endpoint of the study will be the change in glycemic regulation~     by the end of 12 months.~   "
34115|NCT02610517|"~     Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested~     in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine~     the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous~     drinking in the HIV clinical care setting.~   "
34116|NCT02610504|"~     Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into~     the shoulder for pain in mild to moderate patients~   "
34138|NCT02610218|"~     To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells~     (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in~     histologically confirmed HER2 positive advanced/metastatic gastric cancer.~   "
34117|NCT02610491|"~     Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders~     including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition,~     overweight has a causal relationship with a chronic low grade systemic inflammatory~     condition and increased intestinal permeability. Over the last decade, this multiplex~     disorder has progressively become a major worldwide public health problem, because of its~     association with increased risk of type 2 diabetes mellitus (DM2), atherosclerotic~     cardiovascular disease and all-cause mortality. Scientific evidence for measures to improve~     cardiometabolic and intestinal health by non-pharmaceutical means are of urgent need.~     Administration of the flavonoid hesperidin to those at risk may have beneficial effects on~     glucose / insulin metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory~     and oxidative stress biomarkers and gut barrier function.~      Objective: To determine the 12-week effect of daily administration of hesperidin on the main~     cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin~     metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut~     barrier function in subjects at risk for MS.~      Study design: This is a randomized, double-blind, placebo-controlled study with parallel~     design.~      Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic~     syndrome (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).~      Intervention: Participants will be randomly assigned to one of the intervention groups. One~     group will receive one daily dose of hesperidin capsules while the other group receives~     identical looking placebo capsules for a period of 12 weeks. The capsules will have to be~     ingested with a glass of water every morning just before breakfast.~      Main study parameters/endpoints: The primary efficacy parameter of this study is the oral~     glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function~     and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily~     administration of hesperidin on lipid profile (blood measurements), blood pressure and heart~     rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut~     barrier function (blood measurements, fecal samples, urine collection).~   "
34118|NCT02610478|"~     Background:~      Most people infected with the influenza virus have mild symptoms. But some get very sick and~     even die. Antibodies in the part of the blood called plasma fight germs like influenza.~     Researchers want to see if plasma with high levels of antibodies helps more than plasma with~     low levels when transfused into people with influenza. They have plasma from people with~     high levels of antibodies from being infected with influenza or getting the influenza~     vaccine. They also have plasma with low or no antibodies.~      Objective:~      To see if plasma with high levels of antibodies works better than plasma with low levels to~     treat influenza.~      Eligibility:~      People ages 2 weeks and older who are hospitalized for symptoms of influenza~      Design:~      Participants will be screened with medical history and blood and urine tests. They may have~     a nasal wash test for influenza. For this, they get a saline rinse in one nostril. A plastic~     tube inserted in the nostril collects fluid.~      The study lasts 28 days.~      Participants will get routine influenza care. This includes standard drugs and possible~     chest x-rays.~      On Day 1, participants will have:~      Physical exam~      Blood tests~      Throat swab~      2 doses of plasma with high antibodies or low antibodies by IV catheter (tube) in a vein.~      On Days 3 and 7, participants will return to the clinic, if no longer hospitalized, for~     1-hour visits. The visits include:~      Medical exam~      Blood tests~      Throat swab~      On Days 2, 14, and 28, participants will be evaluated either at the clinic or by phone. They~     will talk about their symptoms.~   "
34119|NCT02610465|"~     Background:~      Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make~     pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3~     million of them occurred in the United States. Researchers think CT images can be made~     better using new techniques. Higher resolution images can be derived from the original scan.~      Objective:~      To learn if new ways of obtaining and processing pictures of the body from a regular CT scan~     can produce images with higher resolution (pixels) and more information than standard~     methods.~      Eligibility:~      People ages 18 and older who are scheduled to have a CT scan and are not pregnant~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have their scheduled CT scan.~      The CT scanner used in this study provides enhanced images of inside the body. Researchers~     may use the CT scanner in a research mode to test and improve the pictures.~      Images from the CT scan will be reviewed.~      Any clinical findings from the CT test will be shared with the participant s doctor.~      Participants will continue to receive their medical care from their regular doctor.~      The CT images will be entered into an NIH research database. In the future, they may be used~     for research purposes.~   "
34120|NCT02610452|"~     The main objective of this study was to assess changes in the quality of life of patients in~     a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS)~     before and one hour after the passage of a clown therapist .~   "
34121|NCT02610439|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving~     chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from~     patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to peripheral~     neuropathy.~   "
34122|NCT02610426|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving~     therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients~     with congestive heart failure receiving therapy for breast cancer may help doctors learn~     more about changes that occur in DNA and identify biomarkers related to congestive heart~     failure.~   "
34123|NCT02610413|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab~     for breast cancer. Studying samples of germline DNA in the laboratory from patients with~     hypertension receiving bevacizumab for breast cancer may help doctors learn about changes~     that occur in DNA and identify biomarkers related to hypertension.~   "
34124|NCT02610400|"~     This is a cluster randomised controlled trial with factorial study design comparing the~     impact of reactive community-based malaria interventions: 1) presumptive treatment (or TPE,~     targeted parasite elimination) versus reactive case detection (RACD), and 2) reactive IRS~     (indoor residual spraying) versus control on the incidence of malaria in Namibia.~   "
34125|NCT02610387|"~     Spasticity is one of the most common disorders in patients with central nervous system~     diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a~     noninvasive tool that can be used to modulate cortical excitability of the leg motor area,~     and the spinal motor circuits as well.~      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined~     with Biodex balance training on lower limbs spasticity in chronic stroke patients using~     laboratory and clinical assessments.~   "
34129|NCT02610335|"~     In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms~     receive an epidural infiltration and participate in kyphosis reeducation in first intention.~     Yet the kyphosis reeducation did not show a real profit in the time compared with the~     natural evolution of the pathology. The study assume that the spinal mobility reeducation~     will reduce the incidence of pain recurrences compared with the classic kyphosis~     reeducation.~   "
34130|NCT02610322|"~     Project title: A randomized controlled trial of whole soy diet in place of red/processed~     meat and high fat dairy products on metabolic features in postmenopausal women Objectives:~     Metabolic syndrome (MetS) is an escalating public health problem especially in~     postmenopausal women. Traditional whole soy foods are rich in unsaturated fats, high quality~     plant protein and various bioactive phytochemicals that could benefit on MetS. The aim of~     the study is to examine the effect of whole soy replacement diet on the features of MetS~     among postmenopausal women.~      Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy~     products will significantly improve metabolic features.~      Design and subjects: This will be a 12-month randomized, single-blind, controlled trial~     among 208 postmenopausal women with high risk of MetS or early MetS.~      Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either~     of two intervention groups, whole soy replacement group or control group, each for 6 months.~      Interventions: Subjects in whole soy group will be required to include 4 servings of whole~     soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or~     processed meat and high fat dairy products. Subjects in the control group will remain an~     usual diet.~      Main outcome measures: The outcome measures will include the indices of metabolic features~     as well as a 10-year risk for ischemic cardiovascular disease.~      Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be~     compared among the two groups.~      Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich~     animal products will notably decrease the risk of MetS.~   "
34131|NCT02610309|"~     The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed~     to sufficiently stabilize suicidal adolescents within a single ED visit so that they may~     return home safely with their families. This study is a randomized clinical trial of FBCI v.~     TAU in an urban Emergency Department.~   "
34132|NCT02610296|"~     The purpose of this trial is to evaluate the reduction in incidence and severity of delayed~     graft function with kidney allografts from donors >45 years after brain death (DBD).~   "
34133|NCT02610283|"~     This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in~     subjects who are at high risk for AKI following cardiac surgery. Half of the participants~     will receive QPI-1002 while the other half will receive placebo.~   "
34134|NCT02610270|"~     A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered~     necessary for a good cell function and prevention of various inflammatory processes. Diet~     and supplementation are the fundamental procedures to achieve the reference values for~     several years. Athletes are individuals under physical stress and higher tissue restoration,~     while maintaining adequate diets they show, as the rest of humans, lower than desired~     levels. In the present study the investigators aims to determine the modification of those~     levels by the administration of two different doses of a given product, keeping the same~     model of diet and physical and competition.~   "
34135|NCT02610257|"~     Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor~     impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism~     underlying these phenomena is still an open debate. Apart from the motor correlates,~     cognitive-attentional impairment and somatosensory deficits (especially in the~     proprioceptive system) may underlie these motor blocks. The current study aims to unravel~     whether the proprioceptive system is involved by manipulating task-relevant or non-relevant~     proprioceptive stimuli.~      Hence, the main aims of this study are:~      (i) to assess the somatosensory function in people with PD that experience freezing of gait~     FOG and (ii) to investigate the effects of manipulating both proprioception and attentional~     resources on FOUL severity.~      Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly,~     PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous~     sensory function and kinesthetic ability will be assessed by means of standardized~     user-friendly methods and precise repositioning measures using the VICON motion analysis.~     Additionally, participants will perform a newly developed task that can successfully elicit~     FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The~     task will be performed without and with the use of muscle vibration (a well-known method to~     stimulate the proprioceptive system). The investigators will manipulate both the timing of~     vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region~     of stimulation (neutral: on a bone-mark where there is little if any proprioceptive~     stimulation; and on a non-neutral spot: on the forearm muscles). It is believed that FOG+~     will present with worse somatosensory function than those who do not experience motor blocks~     (especially in the proprioceptive system). Additionally, the Investigators expect a~     reduction in FOUL severity (e.g. FOUL duration) when vibration is applied in a task-relevant~     way, independently of the region stimulated. In contrast, it is also expected that when~     vibration is applied in a non-relevant way and it may act as a distractor, FOUL duration~     will increase. This study will thus be able to distinguish between the contribution of~     attentional and proprioceptive resources to the mechanism of motor blocks in PD.~   "
34136|NCT02610244|"~     ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified~     version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration~     = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there~     is improvement in working memory and attention, a reduction in concerns related to ADHD and~     social emotional behaviour,and transfer effects for reading and math following participation~     in our MCT.~   "
34137|NCT02610231|"~     This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to~     evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with~     moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination~     (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD~     medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day~     follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for~     eligibility for the study. Eligible subjects will be treated with istradefylline at a~     starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on~     the Investigator's judgment of each subject's response and tolerability. If deemed~     necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in~     accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to~     40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled~     dose adjustment visit if there are tolerability issues. The istradefylline dose should~     remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is~     required prior to any unscheduled dose adjustment visits. A subject may discontinue from the~     study at any time.~   "
34139|NCT02610205|"~     The aim of this study was to explore participants´ subjective experiences and perspectives~     on pain and other factors of importance after an early nursing intervention consisting of~     caring touch (tactile massage and healing touch) for participants subjected to a motor~     vehicle accident with minor or no physical injuries.~   "
34140|NCT02610192|"~     The purpose of this study is to evaluate clinical outcomes following a single injection of~     nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis.~     A secondary objective of this study is to document the duration of treatment effect~     following nSTRIDE injection.~   "
34141|NCT02610179|"~     The goal of this prospective study is to determine whether there is superiority of 10~     Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.~   "
34142|NCT02610166|"~     Arthritis in children is a long-term illness and it can make a child's life very difficult.~     In children 8-11 years old, the child and their family work together to deal with the~     problems that arthritis can cause. Learning to cope with and manage the problems that come~     with arthritis can stop it from getting worse. It is important to create programs that teach~     children and families how to cope with and manage arthritis. This study will develop and~     test an online game that helps children learn how to better manage their arthritis. The goal~     of these studies is to test: (1) how easy to use and acceptable the online game is; and (2)~     if children who play the game feel less pain, have fewer limitations, and a better quality~     of life compared to children who do not play the game.~   "
34143|NCT02610153|"~     This prospective observational study is to assess the predictive factors of poor control of~     international normalized ratio (INR) to determine the treatment strategies received by~     patients with a poor control of INR in real-life clinical practice and to explore the~     effectiveness and safety of these strategies in patients with non-valvular atrial~     fibrillation who start vitamin K antagonist (VKA) treatment~   "
34144|NCT02610140|"~     The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine~     versus vinorelbine in progression free survival in patients with stage IV mesothelin~     overexpressing malignant pleural mesothelioma (MPM).~      210 eligible patients will be randomized to receive either anetumab ravtansine every three~     weeks or weekly vinorelbine.~      Treatment will continue until centrally confirmed disease progression (PD) or until another~     criterion is met for withdrawal from the study. Patients will enter follow up phase to~     capture safety and endpoint data as required.~      Efficacy will be measured by evaluating progression free survival from randomization.~     Radiological tumor assessments will be performed at defined time points until the patient's~     disease progresses.~      Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival~     or fresh biopsy tissue may also be collected for central pathology review and biomarkers.~   "
34145|NCT02610127|"~     The overall objective is to enroll patients with acquired hemophilia A (AHA) who are~     prescribed and treated with Obizur, to assess safety, and to describe factors related to~     safety, utilization and effectiveness in a real-world setting.~   "
34146|NCT02610114|"~     It is the aim of this trial to use a new computerized cell selection method, in addition to~     the current and world-wide used scoring system of fertilized oocytes implemented by Scott,~     to determine whether this leads to an increase in pregnancy rates in women undergoing~     assisted reproductive techniques.~   "
34147|NCT02610101|"~     The goal of any research study is to answer questions. The investigators are doing this~     research study to answer questions about a nutritional therapy called the Specific~     Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD). The SCDiet is a diet~     where all grains such as wheat, barley, corn, rice are restricted. Most dairy products~     (except certain yogurt) are also restricted. The diet mainly consists of meat, fruits,~     vegetables, nuts, oils and honey, and is offered to individuals with active Crohn's disease~     as part of standard of care at Seattle Children's.~      For this study, the investigators will have three different dietary groups: 1.) Traditional~     SCD diet group 2.) Modified SCD to include oatmeal and rice 3.) SCD with whole foods without~     added sugar, specifically, the investigators want to know:~        -  Is the SCD well tolerated?~        -  Is SCD effective for the treatment for active Crohn's Disease?~        -  Will the results from the varied three dietary groups have the same results for each~          patient?~   "
34148|NCT02610088|"~     The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium~     glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with~     type 2 diabetes~   "
34149|NCT02610075|"~     This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy~     when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed~     by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2~     days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours.~     Alternative treatment schedules may be explored if preliminary data suggest these would be~     more appropriate.~      The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this~     sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in~     the fasted state and once following a high-fat meal.~   "
34150|NCT02610062|"~     The purpose of this study is to evaluate the safety and tolerability of AGS67E given at two~     dosing schedules (every three weeks or weekly), in subjects with acute myeloid leukemia~     (AML) and determine a safe dose for future development. In addition, this study will assess~     the pharmacokinetics (PK), the immunogenicity, and the antitumor activity of AGS67E.~   "
34151|NCT02610049|"~     This is a randomized, controlled trial of adjunctive art therapy during cognitive processing~     therapy for PTSD.~   "
34152|NCT02610036|"~     The purpose of this study will be the assessment of microangiopathy determined by the~     increase of capillary basement membrane thickness and decrease of capillary lumen area in~     the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients~   "
34153|NCT02610023|"~     Fruits and vegetables are an important source of many different phytochemicals that may~     affect health and accurate dietary assessement tools to quantitate dietary intake are~     essential. This study will evaluate the correlation of dietary carotenoid intake estimated~     from two common and one novel food frequency questionnaire (FFQ) with estimated carotenoid~     intake from 3 day diet records as well as measured blood and skin concentrations of~     carotenoids. This study will be conducted in healthy adults. These tools may be effective in~     estimating the level of these compounds in an average diet.~   "
34154|NCT02610010|"~     A prior phase III randomized trial showed considerable survival benefit from the combined~     treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional~     radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system)~     nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known~     to be superior to 2DCRT in local control, progression free survival and even overall~     survival, it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010~     International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging~     system] patients can still obtain significant benefit from the additional concurrent~     chemotherapy in the IMRT era.~      The investigators' retrospective study (PMID:26528755 ) indicated that low risk~     nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system)~     patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy.~     Therefore, the investigators perform this randomized controlled trial to address this~     question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent~     chemotherapy in stage II patients.~   "
34155|NCT02609997|"~     Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have~     enabled the transition of cataract surgery from blindness relief to refractive correction.~     An ideal IOL is the critical component to achieve the refractive target of cataract surgery.~     Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all~     been suggested as the critical factors of an ideal IOL and widely investigated. Recently,~     stability of IOL position has also been suggested as one of those critical factors due to~     its close correlation with postoperative visual function. Data suggests that IOL forward~     movement of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and~     colleagues recently reported that 0.5mm decentration of an aspheric IOL could eliminate its~     aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional~     surgery that put both surgeons and patients in pain.~      As the supporting element of an IOL, the haptics are crucial to keep the IOL in place.~     Various haptic designs are being compared in terms of position stability of IOLs. Haptic~     designs of single-piece versus 3-piece are often compared because they are currently the~     most commonly used types. Single-piece IOLs have soft and broader haptics which are made of~     the same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece~     IOLs have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies~     comparing these haptic designs have yielded controversial results regarding their position~     stability in the capsular bag, which is the most recommended site for IOL fixation in an~     uneventful cataract surgery.~   "
34156|NCT02609984|"~     This is an open-label Phase 2 randomized study that will examine the use of the study~     agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector~     expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in~     combination with atezolizumab or atezolizumab alone, in patients with locally advanced,~     relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the~     NY-ESO-1 protein.~      CMB305 is a novel approach designed to stimulate the body's immune system to fight the~     spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305~     will be given in a prime-boost approach with G305 to induce a potentially synergistic~     immunotherapeutic response in combination with atezolizumab.~   "
34157|NCT02609971|"~     The purpose of this study is to analyze the immediate effects of two exercises protocols on~     the whole body vibration, on the strength of the thigh muscles, joint position sense of the~     knee and balance in individuals submitted to anterior cruciate ligament reconstruction.~   "
34158|NCT02609958|"~     This is a single arm, multicentre, Phase 2 study to assess efficacy and safety of ASLAN001~     in patients with advanced or metastatic cholangiocarcinoma who progressed on at least 1 line~     of systemic therapy.~      25 evaluable patients will be enrolled in the study. After evaluation of initial response in~     the first 10 evaluable patients, Sponsor will make a decision on recruitment of an~     additional 15 evaluable patients. If no response is observed, the study will stop.~      The primary objective is to assess efficacy of varlitinib (also known as ASLAN001) as~     measured by ORR (based on RECIST v1.1). The secondary objectives are to (1) evaluate the~     efficacy of varlitinib, as measured by DoR, PFS, OS and DCR, (2) assess ORR, DoR, PFS, DCR~     and OS by tumor EGFR/HER2 status, (3) assess safety and tolerability of ASLAN001~     monotherapy. Exploratory objectives are to explore possible relationships between response~     to ASLAN001 and the protein expression levels and gene mutational status of the proteins and~     genes via IHC and PCR/Sequencing.~   "
34159|NCT02609945|"~     This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is~     designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427~     in adult healthy volunteers.~   "
34160|NCT02609932|"~     The investigators hypothesize that neutrophils and monocytes developed under the influence~     of Interferon- gamma-1b (IFN-γ-1b, Actimmune*) in vivo will display enhanced function across~     a broad range of activities related in large part to the transcriptional activation effects~     of this cytokine. The investigators will evaluate the effects of IFN-γ in healthy human~     subjects in vivo on gene expression, biologic activity markers, and functional activity of~     myeloid cells in single dose studies and in steady state studies.~   "
34161|NCT02609919|"~     Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24~     hours after Dotarem injection. Patients will be monitored for any adverse events that occur~     for 2 hours following the completion of the MRI exam. The type of event, time of onset,~     duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not~     related, probably related, related, definitely related, unclassifiable), and subsequent~     outcome (required treatment, favorable outcome, recovery with sequela, or death) will be~     documented. Parents will be given instruction sheets on who and when to call should any~     adverse event occur after discharge. Parents will be called by the radiology department the~     next day to identify any adverse events that occurred during the first 24 hours after~     discharge from the hospital.~      Our secondary outcome is to assess image quality of the exam. The pre-contrast images will~     be compared to the combined pre- and post-contrast images following administration of~     Dotarem by radiologists who are blinded to the patients' clinical information to assess for~     improvement of image quality and delineation of structures with contrast.~   "
34162|NCT02609906|"~     Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in~     the elderly. Compared to fractures of the upper limb it is the second most common fracture~     after distal radial fractures. 65% of all patients with a proximal humeral fracture are~     older than 60 years. Being aware of the demographic change there will even be an increase of~     incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at~     least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50%~     until 2030.~      Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated~     conservatively with a good functional result. In 20% of humeral fractures there is an~     indication for surgical treatment according to the modified Neer-Criteria. These criteria~     are fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a~     displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation~     of the tuberculum of at least 5 mm.~      Up to now there is evidence for superiority of any surgical treatment in literature. At the~     moment the most frequently used surgical technique for treatment of proximal humeral~     fractures is the angle stable plate fixation. There are various publications concerning this~     topic published by the investigators research group. In their 10-years results a majority of~     patients showed excellent and good, but also 16% showed unsatisfactory results after locking~     plate fixation. Main risk for poor outcome was revision surgery caused by secondary~     displacement (14%) which is also confirmed by results of other studies. In a further study~     investigators could show that there is a higher risk for secondary displacement in~     2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO~     11-A3), especially in osteoporotic patients. More over these are common fractures and~     because of that a problem in surgical treatment.~      A secondary varus dislocation of the head fragment and cutting-out are the most common~     complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The~     primary reason for this mechanism of failure is certain instability of transmetaphyseal~     fractures in the region of the surgical neck caused by loss of impaction in a porous~     spongiosa. Because of that the forces on the head screws are high while the so called~     screw-bone-interface is rather weak after a surgical treatment.~      Currently there exist various approaches to avoid a failure of the primary screw~     implantation. One possibility to increase the stability of the screw-bone-interface is the~     cement augmentation of the screw tips. To date there exist no clinical study that reports~     the results of locking plate fixation and the augmentation of cannulated head screws~     although it is a widely used method in everyday surgery, especially in the elderly.~      A second possibility to prevent secondary displacement after surgical treatment of~     2-fragment-fractures is the use of an intramedullary nails. A further development of~     intramedullary nails is multiplanar nailing. Screws can be inserted in various different~     levels and directions which can lead to a clearly higher stability.~      A comparison of these two treatment options augmented locking plate versus multiplanar angle~     stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.~   "
34163|NCT02609893|"~     This project is a randomized trial of two strategies to treat persons with genotype 1 HCV~     who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir~     (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility~     and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly~     observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based~     adherence support; and assess through in-depth, semi-structured qualitative interviews, the~     challenges with time intensity required for mDOT and unobserved dosing interventions, and~     identify key factors affecting treatment adherence.~   "
34164|NCT02609880|"~     Gynecologic cancers cause substantial morbidity and mortality among women. Developing,~     implementing, and disseminating interventions that reduce morbidity and mortality secondary~     to gynecologic cancers are a public health priority. In spite of this, there is a paucity of~     research examining the effects of psychosocial interventions on patient-centered and~     physiological outcomes in this population. To the extent that psychological factors may~     influence quality of life and tumor biology among women with gynecologic cancers,~     psychological interventions may represent an important adjunct to standard clinical care in~     this population. As such, this study will examine the effects of a psychosocial intervention~     on sleep, pain, mood, cortisol, and cytokines in women with gynecologic cancers.~   "
34165|NCT02609867|"~     The purpose of this study is to evaluate the safety and short-term effectiveness of~     implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked~     cerebral aneurysm in the internal carotid artery.~   "
34166|NCT02609854|"~     ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical~     device which, when applied to various areas of the body applies Low Intensity Therapeutic~     Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment~     of muscle spasm and joint contracture, and increasing local circulation. This study will~     look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects~     with chronic low back pain, a subset of which will have chronic low back pain due to a~     herniated disc, over an 8-week treatment period.~   "
34167|NCT02609841|"~     This study assesses serum potassium and cardiac rhythm trends in subjects with end stage~     renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60~     days. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks~     prior to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60,~     with the remainder of the subjects on 1K or 2K dialysate.~   "
34168|NCT02609828|"~     The purpose of this study is to determine whether tanezumab is effective in the treatment of~     cancer pain due to bone metastasis in patients already taking background opioid therapy.~   "
34169|NCT02609815|"~     The purpose of this study is to investigate gut microbiota change and glucose lowering~     effect of initial combination therapy of gemigliptin and metformin compared to glimepiride~     and metformin in obese patients with type 2 diabetes.~   "
34170|NCT02609802|"~     The aim of this clinical trial is to evaluate the difference of analgesic potency of~     sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth~     index.~   "
34171|NCT02609789|"~     The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following~     single ascending intravenous (IV) dose administration in healthy participants and a single~     subcutaneous dose in healthy participants and multiple IV dose administrations in~     participants with mild to moderate Systemic Lupus Erythematosus (SLE).~   "
34172|NCT02609776|"~     The purpose of this study is to evaluate the safety and pharmacokinetics, establish a~     recommended phase 2 dose (RP2D) regimen, and to assess the preliminary efficacy of~     JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).~   "
34173|NCT02609763|"~     This observational study will test the inter-rater and test-retest reliability of the LESS~     scale in a live context.~   "
34174|NCT02609750|"~     WorkUp is a prospective cluster randomised controlled trial in primary care. The main~     purpose is to investigate effects of early structured care based on screening of red flags~     (signs of serious medical conditions/disease), yellow flags (psychosocial factors, attitude~     to pain) and blue flags (workplace related factors) and including a workplace intervention~     according to the method Convergence Dialogue Meetings (CDM) for improving work ability, in~     comparison with treatment as usual, in patients with neck and/or back pain.~   "
34175|NCT02609737|"~     This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to~     see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors~     (step 2 and 3).~   "
34176|NCT02609724|"~     The main scientific objective of this multicentric double-blinded randomised controlled~     trial entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD~     versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive~     Lymphatic Therapy, for the treatment of BCRL Secondary scientific objectives entail~     examining the relationship between different variables of lymphoedema at baseline~   "
34177|NCT02609711|"~     primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and~     Atorvastatin~   "
34178|NCT02609698|"~     This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary~     artery disease in order for the objective of verifying the non-inferiority of results that~     among patients who were administered DAPT for 3 months compared to patients who were~     administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.~   "
34179|NCT02609685|"~     The purpose of this study is to better understand the outcomes of active surveillance~     (observation) instead of immediate surgery, which is the current standard of care for~     papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s)~     with papillary thyroid carcinoma will be eligible for the study.~   "
34180|NCT02609672|"~     Exercise is effective at reducing pain while improving physical function. However we do not~     know if exercise can boost resilience in the workplace, to allow people with osteoarthritis~     to work as long as they desire. Previous research shows that exercise holds the most promise~     for helping people enjoy their work because it reduces sick time, reduces pain, and improves~     productivity. However, little work has examined the effect of exercise for people with~     arthritis in the workplace. The purpose of the study is to investigate whether exercise~     improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to~     no exercise in those with knee and/or hip osteoarthritis.~   "
34181|NCT02609659|"~     This study seeks to assess the safety and efficacy of treatment with~     ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in non-cirrhotic, genotype 1a~     (GT1a) hepatitis C virus infected participants who are treatment-naïve or~     treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without~     Ribavirin (RBV).~   "
34182|NCT02609646|"~     The purpose of this study is to investigate the pharmacokinetic properties in critically ill~     patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem,~     piperacillin/tazobactam, vancomycin). The primary objective is the identification of the~     clinical parameters affecting the kinetics of these drugs and the study of the contribution~     of extracorporeal depuration techniques to the elimination of these molecules. The secondary~     objective is to describe and compare the therapeutic therapies adopted in the Intensive Care~     Units participating in the project.~      For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For~     each patient five blood samples will be collected on average, in order to measure drug~     plasma concentrations. Patient clinical conditions will be collected through an electronic~     clinical record. Finally, on the basis of those data, pharmacokinetic models will be~     developed to describe the evolution in time of drug plasma concentrations.~   "
34183|NCT02609633|"~     This interventional, 6-month post-marketing study is designed to evaluate the change in~     diabetes-related distress among parents/caregivers of school-age children and adolescents~     with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy.~     Investigational sites will be assigned using cluster randomization, with approximately 10 to~     20 children at each site. In order to maintain a true control group for comparison, the~     investigational sites will be randomly assigned to the Accu-Chek(R) Connect diabetes~     management system (DMS) or usual care/continued use of current DMS devices.~   "
34184|NCT02609620|"~     This study is designated to test the safety and initial efficacy of the LunGuard's PFT~     device for reduction of GER.~      Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will~     have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will~     be taken by suction on predetermined intervals and analysed for Pepsin A concentration.~      The PFT will be removed upon completion of the study's scheduled routine. Patients in the~     control group will have a standard polyurethane nasogastric device inserted according to~     standard procedure, which is considered the gold standard.~   "
34185|NCT02609607|"~     The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10~     mg rectal suppository every other day improves bowel-related symptoms in patients with~     multiple sclerosis. Patients will be randomized to receive either a placebo suppository or~     bisacodyl suppository dosed every other day for 4 weeks.~   "
34186|NCT02609594|"~     Lower extremity ulcers pose significant clinical, humanistic and economic burdens on~     society. Millions of Americans are afflicted with painful, open, draining sores on their~     lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under~     the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound~     care specialists see patients who have suffered for years or faced amputation of the limb as~     their only option to alleviate the pain.~      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,~     roughly half of patients suffering from venous ulcers will require advanced therapy. Human~     amniotic membrane replaces the damaged extracellular matrix characteristic of chronic~     ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice~     and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as~     bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human~     Amniotic Membrane in venous leg ulcers.~   "
34187|NCT02609581|"~     To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites~     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual~     therapy in special consideration of the chosen titration schedule in everyday practice.~   "
34188|NCT02609568|"~     By studying individual biomarkers in body fluids such as saliva, there is a potential for~     detecting injury to the brain resulting from an acute traumatic even that may not be~     detectable by conventional neuroimaging like CT scans.~   "
34189|NCT02609555|"~     Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of~     Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh~     between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.~   "
34190|NCT02609542|"~     The disorder of oral language development is defined by the delay in language acquisition in~     children who possess efficient auditory acuity and normal non verbal intellect.~      The diversity of language developement disorders depends either in the expressive level or~     in the receptive level leading to divers syndromes and symptoms. These syndromes and~     symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).~      In the current project the visual exploitation and learning capability of children~     presenting a STOL condition will be compared to patients with a normal development. The~     investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced~     between 4 and 7 years of age will present a better performance at verbal memorisation,~     compared to patients with a persistent STOL condition after the age of 6.~   "
34191|NCT02609529|"~     IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic,~     accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with~     defecation, characterized either as diarrhea predominant or constipation predominant. About~     one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for~     children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome~     d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived~     bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild~     inflammation in the small intestine associated with some cases of d-IBS, especially those~     arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our~     aim is to determine if SBI improves the number of spontaneous bowel movements in children~     with d-IBS.~   "
34216|NCT02609204|"~     The main goal of the study is to compile a normative database for the Neuro Optic Vision~     Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)~     modules. This normalization intends to be included in a probabilistic analysis protocol to~     allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges~   "
34192|NCT02609516|"~     Life expectancy at age 65 in the most deprived fifth of the English population was about 4~     years shorter than of the most affluent fifth in 2010. The inverse gradient between~     mortality and social position is well established. But how disease patterns and~     multimorbidity (having two or more long term conditions at the same time) impact on~     differential mortality rates is inconclusive: is it because disadvantaged groups acquire~     more or more lethal combinations of, diseases over their life course; or, simply, become ill~     at ages younger than more affluent groups?~   "
34193|NCT02609503|"~     This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and~     following standard of care definitive radiation, for locally advanced squamous cell~     carcinoma of the head and neck patients who are not good candidates for Cisplatin.~   "
34194|NCT02609490|"~     A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese~     hypertension patients~   "
34195|NCT02609477|"~     This study is to evaluate the abuse potential of single-doses of istradefylline compared to~     placebo and phentermine in recreational stimulant users. Subjects will participate in an~     outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a~     6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be~     approximately 25 weeks total.~      Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day~     -1) for the Qualification Phase. During the Qualification Phase, subjects will receive~     single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind,~     crossover manner, with each drug administration separated by approximately 48 hours (Day 1~     and Day 3), to ensure that they can discriminate and show positive subjective effects of the~     active controls. Following evaluation of eligibility, subjects may be discharged (those who~     fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible)~     and then proceed directly to the Treatment Phase. The washout interval between last drug~     administration in the Qualification Phase and first drug administration in the Treatment~     Phase will be at least 96 hours (4 days).~      Following confirmation of eligibility from the Qualification Phase, subjects will be~     randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will~     receive single oral doses of each of the 6 treatments in a randomized, double-blind,~     crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg,~     Phentermine 45 mg, Phentermine 90 mg, Placebo.~      Each drug administration will be separated by at least 21 days. Serial pharmacodynamic~     evaluations will be conducted up to 24 hours after each study drug administration to confirm~     exposure to istradefylline.~   "
34196|NCT02609464|"~     The purpose of this study is to evaluate the role of new barbed suture for closure of wound~     during total hip arthroplasty in reducing the risk for wound healing problems.~   "
34197|NCT02609451|"~     The purpose of this study is to compare the feasibility, safety, and quality of life (QOL)~     in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after~     12 weeks.~   "
34198|NCT02609438|"~     The purpose of this study is to determine whether varying the frequency and length of~     activity breaks during the workday will differentially impact sedentary behavior and health~     outcomes. Participants will be randomly assigned to take short, frequent breaks (i.e., 1~     minute every half hour) or longer, planned breaks (i.e., two 15-minute walks) from sitting~     during the workday. They will be instructed to follow the assigned protocols for an 8-week~     intervention and the effects of their participation on sedentary behavior and a variety of~     health outcomes will be assessed. The investigators anticipate participants in both~     intervention arms will demonstrate significant reductions in daily sitting time, bit do not~     have an a priori hypothesis regarding the relative effectiveness of each approach.~   "
34199|NCT02609425|"~     Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims:~     1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by~     measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in~     esophagogastric anastomosis by measure anastomotic stricture rate.~   "
34200|NCT02609412|"~     Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in~     both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into~     active trigger points, therapy seems warranted. Besides other modalities, self-massage using~     foam rollers (self-myofascial release) has been applied as a treatment. However, there is no~     data on the efficacy of this method concerning LMTRP. Thus, the present study aims to~     evaluate the effects of different forms of self-myofascial release on LMTRP pain.~      Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1)~     90s static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic~     self-myofascial release rolling back and forth on the calf muscles for 90s using a foam~     roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate~     in a familiarization session with the foam roller one week prior to treatments. As an~     outcome, pressure pain threshold is assessed with an algometer. The investigators~     hypothesize, that static compression can reduce pressure pain of LMTRP more effective than~     dynamic self-myofascial release. The investigators further expect that placebo treatment~     will be the least effective method.~   "
34201|NCT02609399|"~     This pilot study is designed to demonstrate the feasibility of utilizing Emergency~     Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating~     influenza therapeutics, and to provide pilot data for future clinical trial design and~     planning.~      Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed~     influenza into a randomized, open label study of oral versus IV influenza therapeutic to~     include symptom evaluation and outcome assessments.~      Secondary Objective 1: To identify influenza positive patients utilizing a previously~     established triage-based assessment and rapid testing algorithm for suspected influenza~     infection.~      Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for~     potential enrollment biases.~      Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected~     from ED patients with suspected influenza illness.~   "
34202|NCT02609386|"~     The purpose of this study is to determine whether a pre-operative regimen of the study drug,~     IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single~     dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing~     multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is~     intended to stimulate an immune response against the cancer.~   "
34203|NCT02609373|"~     Shift work with circadian disruption has been linked with increased breast cancer incidence.~     The mechanisms for this effect are not yet completely understood.~      This study evaluates the impact of a previously developed sleep intervention in shift~     workers at risk of breast cancer; and assesses mediating variables that may explain the~     relationship between shift work and breast cancer.~      A sample of women night shift workers were provided with a sleep intervention. The~     intervention is a standard approach used in a sleep clinic and is delivered by telephone by~     a trained intervener.~      Hypothesis: The intervention will improve sleep in women night shift workers, which will in~     turn have a positive impact on biological and behavioural risk factors associated with~     breast cancer and quality of life.~   "
34204|NCT02609360|"~     Crystalloid solutions modify acid-base equilibrium according to their electrolyte~     composition. Moreover, it has been suggested that these alterations are generated by the~     difference between the solution strong ion difference (SID) and the plasma bicarbonate~     level. An increased risk of acute kidney injury and renal replacement therapy has been~     associated to the infusion of chloride rich crystalloids. This study aims to compare, in~     patients with acute respiratory failure undergoing ECMO support, the effects on acid-base~     status and renal function of crystalloids commonly employed for circuit priming to a~     balanced solution created with a SID equal to patients' bicarbonate level.~   "
34205|NCT02609347|"~     The aim of this randomized controlled trial is to assess if manual therapy improves~     mobility, gait, and balance more than a control group for patients who have undergone open~     reduction internal fixation (ORIF) after an ankle/hindfoot fracture.~   "
34206|NCT02609334|"~     This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating~     two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a~     positive asthma test (mannitol challenge) prior to enrolment.~   "
34207|NCT02609321|"~     Surgical treatment of breast cancer is frequently associated with postoperative pain in the~     surgical area. Persistent pain after breast cancer management has considerable negative~     effects on the quality of life of survivors. The aim of this trials is to evaluate the~     efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain~     postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.~   "
34208|NCT02609308|"~     Lateral ankle sprains are one of the most common in sports medicine. Considering the sprains~     in general, they represent an 85% of the ankle lesions. The incidence in high performance~     athletes range from 16 to 21%. It is estimated that 10,000 to 25,000 peoples suffers a~     lateral ankle sprain per hour in the United States. The objective of the treatment is to~     normalize the articular function and allow the patient to return to his or her normal~     physical activities. Platelet rich plasma is a simple of autologous blood with~     concentrations of platelets above baseline values. This is rich in platelet derived growth~     factor which stimulates cell replication, angiogenesis, transforming growth factor B1,~     fibroblast growth factor, epidermal growth factor, and insulin like growth factor. The risks~     of its applications are minimal and are usually involved with allergic reactions to other~     medications that are applied in combination with the platelet-rich plasma.~      To establish that the use of platelet rich plasma and immobilization with a short leg cast~     in acute lateral ankle sprains will enhance an early recovery in comparison with just~     immobilization with the cast.~   "
34209|NCT02609295|"~     This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and~     the relationship between these alteration and lipoprotein associated phospholipase A2~     (Lp-PLA2) activity.~   "
34210|NCT02609282|"~     This study aims to investigate whether hourly prompts, delivered by Microsoft Office onto~     the PC's of office workers, is effective at reducing unhealthy patterns of sedentary~     behaviour .~   "
34211|NCT02609269|"~     To prospectively evaluate the utility of genomic expression data as a tool to better~     characterize the tumors of individual patients, and to understand how genomic information~     from individual patients undergoing routine clinical testing can be used in population-level~     analysis to improve treatment and outcomes.~   "
34212|NCT02609256|"~     Malignant middle cerebral artery infarction(MMCI) has a high rate of disability and~     mortality. At present, there is no effective treatment except for craniotomy decompression,~     but the controversy of the craniotomy decompression still exists. The project is a~     prospective, randomized, single center, open label, clinical controlled trail. The eligible~     patients for enrollment are as follows: (1) malignant cerebral artery infarction within 48h~     onset; (2) craniotomy decompression can not be performed due to the contraindications, or~     refused by the patient or relatives. The patients are randomly assigned into 2 groups:~     (1)Medical therapy group: receiving osmotic therapy with mannitol and glycerol~     fructose，anti-platelet treatment, statins, and other symptomatic treatments such as~     controlling blood pressure, blood sugar, and infection, tracheal intubation or incision,~     etc; (2) Stereotactic infarct tissue aspiration (SITA) group: on the basis of medical~     treatment, receiving minimally invasive aspiration of infarct tissue 24-48 hours after~     stroke attacked. This study is aimed at comparing the efficacy and safety of of SITA in~     patients with MMCI.~   "
34213|NCT02609243|"~     Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance,~     is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies~     to prevent progression from prediabetes to diabetes have been widely studied, however,~     without striking long-term effects of any kind of intervention (pharmacological,~     behavioral...). The investigators therefore investigate certain nutritional approaches~     concerning nutrient content and favorable food components, targeting metabolic improvement.~   "
34214|NCT02609230|"~     This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II~     dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple~     myeloma.~   "
34215|NCT02609217|"~     The aim of this study is to gain insight in the experiences and expectations of Belgian~     parents concerning primary cesarean section. This will be achieved by structured patient~     interviews and questionnaires in 24 women undergoing the procedure and their partners. This~     group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and~     their partners.~   "
34228|NCT02609048|"~     A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the~     effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an~     inadequate response to ursodeoxycholic acid (UDCA)~   "
34217|NCT02609191|"~     The main objective of this study is to validate the measurement characteristics of a new~     bone densitometer, the Stratos DR:~        -  Via cross calibration to the results of body composition (BC) measurement results to~          those of a reference device (the Discover A by Hologic) in terms of body fat~          percentage, lean mass percentage of total body mass and for different subregions (left~          and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right~          legs, head, android area, gynecoid area, visceral region).~        -  And by the evaluation of the reproducibility of the BC measurement results in terms of~          fat mass and lean mass.~   "
34218|NCT02609178|"~     The purpose of this study is to compare among different designs of the occlusal surface of~     artificial crowns, trying to determine a guidance of fabricating artificial crowns with~     better mimesis of the original tooth crown in terms of morphology.~   "
34219|NCT02609165|"~     This study aims at investigating the therapeutic potential of recombinant human Nerve Growth~     Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated~     with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled~     clinical trial.~   "
34220|NCT02609152|"~     The main objective of this study is to evaluate the effectiveness of the administration of a~     short acting beta-blocker in terms of effective increase in stroke volume (at least 15%)~     after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile~     after 12-24 hours of care.~      This research seeks to demonstrate that the proportion of patients with an increase in the~     systolic ejection superior or equal to 15% (relative to baseline) at four hours is different~     between the two arms of the study: (1) an experimental arm where patients receive an esmolol~     infusion according to a predetermined procedure and (2) a control arm where patients receive~     a saline infusion according to a predetermined procedure.~   "
34221|NCT02609139|"~     This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study~     to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted~     and high fat meal fed conditions in healthy subjects.~   "
34222|NCT02609126|"~     The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to~     determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The~     study will also provide some preliminary insights into whether the experimental treatment~     reduces pain in the knee.~      Osteoarthritis is the most common joint disease, affecting over 20 million people in the US~     alone. Currently, pain treatments that are injected directly into the knee often work for~     only a short time and may also have side effects within the rest of the body. The~     experimental treatment is a steroid that is in the same family of drugs as the most common~     current injectable treatments for knee osteoarthritis. For this study, the drug is coated~     with a polymer intended to prolong the time it stays inside the knee and lessen potential~     side effects.~   "
34223|NCT02609113|"~     The purpose of this research study is to investigate if magnet therapy is effective as an~     alternative therapy for CTS.~   "
34224|NCT02609100|"~     Acute gastrointestinal bleeding is a common medical problem. When patients with~     gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually~     originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first~     step in evaluating the patient is an upper endoscopy; which allows direct visualization of~     the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small~     bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has~     been the next test preformed if upper endoscopy does not identify the cause of melena/~     gastrointestinal bleeding, however less than 25% of patients who present with melena have~     bleeding originating in the colon, and the remainder of patients have bleeding originating~     in the small intestine, which can only be fully evaluated with video capsule endoscopy (a~     pill camera which is swallowed and takes pictures while it travels thought the small bowel~     and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not~     identify the cause of bleeding. The investigators are preforming a randomized study which~     seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the~     cause of gastrointestinal bleeding in patients who present with melena and have normal~     findings on upper endoscopy. To do this the investigators will enroll patients who present~     with melena prior to their upper endoscopy and if the cause of bleeding is not identified at~     that time patients will be randomized to video capsule endoscopy (with the capsule being~     placed into the small bowel during the upper endoscopy) or next day colonoscopy.~   "
34225|NCT02609087|"~     The aim of this study is comparing the effect on cerebral oxygenation by~     sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid~     endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane~     and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol~     decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the~     cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in~     general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are~     acceptable. There is little data about the effect of general anethetics on cerebral~     oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral~     circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than~     propofol in patient have impaired cerebral circulation.~   "
34226|NCT02609074|"~     Objective: The investigators initiated a pilot clinical study to test safety and preliminary~     efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and~     rehabilitation protocols.~      Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been~     considered as the most perspective among all bone substitutes, yet little progress of its~     clinical translation has been made. The concept of micro-scaffolds was proposed in this~     study to provide a trajectory to its clinical translation.~      Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further~     applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.~     Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at~     a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2~     microffolds or traditional CPC paste (control group).~   "
34227|NCT02609061|"~     The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the~     treatment of mandibular degree II furcation defects when compared with PRF and open flap~     debridement (OFD) alone.~   "
34230|NCT02609022|"~     Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical~     trial is a safety and proof-of-concept study (proof of mechanism of action) intended to~     assess the safety, tolerability and immunogenic response following 3 subcutaneous injections~     of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis~     (MG) patients.~   "
34231|NCT02609009|"~     Adolescent idiopathic scoliosis (AIS) affects 2 - 3% of children and adolescents older than~     10 years and is of unknown cause. It was initially thought that back pain (BP) occurrence~     was similar to the one encounter in healthy adolescents. Recently though, literature has~     shown that BP seems to occur twice as often than in a healthy adolescent's. As such, BP~     appears as a condition that might have detrimental effect on the well-being of that~     population, and, as the investigators know, is associated with increases in healthcare~     costs. Of interest, BP in adolescents would appear to be a predictive factor for adult BP.~     Is vertebral manipulation (VM) a viable alternative? Since 2006, four guidelines were in~     agreement as to the value of that approach with acute or chronic BP in adults.~     Unfortunately, no study was found in adolescents. The purpose of the investigators study is~     to verify if VM is efficacious at improving AIS patients' back pain and to find out if it~     can help these patients to obtain a better quality of life and improve their spinal~     flexibility. Recruitment will take place at the Ste-Justine's hospital where patients will~     have 2 evaluations, conducted by an independent orthopaedist (baseline and 4 weeks).~     Patients will be allocated to either the experimental (VM) or the usual medical care group.~     Spinal manipulation treatment will spin over a 4-week period. The investigators study will~     be the first trial evaluating the efficacy of vertebral manipulation in adolescent~     idiopathic scoliosis patients with back pain. Finally, no other study was found on available~     and effective treatment in regard to back pain management of this population. A~     well-structured trial is needed to provide clinicians with a better understanding and best~     evidence regarding treatment protocols.~   "
34232|NCT02608996|"~     Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial~     infarction, and heart failure. Its myocardial complications result from increased mechanical~     load on the heart. Under physiological conditions of increased myocardial load and resulting~     myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP)~     synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood~     pressure homeostasis. However, studies indicate that in subjects with cardiovascular~     diseases the biological structure of these hormones may be altered, thus reducing their~     favorable protective activities. New studies indicate that early and moderate hypertension~     is associated with a derangement of the natriuretic peptide system which is characterized by~     the lack of activation of biologically active ANP and BNP, while severe hypertension is~     characterized by Cardiac release of altered molecular forms of ANP and BNP that have reduced~     biological Properties and/or enhanced degradation.~      The broad objective of this proposal is to advance the biology and therapeutics of the NPs~     with a special focus on the cardiac peptide BNP in human hypertension. Our proposal is based~     upon the biological properties of BNP (i.e. natriuretic, renin-angiotensin-aldosterone~     suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its~     mechanistic role in human hypertension, and thus its potential as an innovative chronic~     protein therapeutic to enhance the treatment of patients with uncontrolled hypertension.~     Importantly, BNP is an endocrine hormone normally produced by the human heart, and it has~     been approved for the treatment of acute heart failure in USA.~   "
34233|NCT02608983|"~     Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in~     dietary fibre, proteins, essential vitamins and minerals. However this resource is highly~     underexploited. Countries such as Japan, China, North and South Korea are large consumers of~     edible seaweed while exposure in Western countries is much lower and mainly as industrially~     extracted seaweed derivatives, a common additive in many food and healthcare products.~     Seaweeds have been associated with a number of human gut promoting health benefits such as~     decreasing faecal transit time through the gastrointestinal tract thus preventing~     constipation and resulting in a reduced exposure to harmful substances (decreasing colon~     cancer risk). These health benefits can be attributed to seaweeds high dietary fibre~     content. Interestingly, the food and healthcare industry already utilize seaweed-extracted~     fibre in the manufacturing process thus steering the way forward towards the development of~     novel functional food products. These seaweed-extracted fibres are high molecular weight~     polysaccharides known as hydrocolloids and are non-digestible by humans, hence classified as~     dietary fibre.~      Traditionally, seaweed derived polysaccharides (hydrocolloids) have been used to provide~     thickening and gelling functionality to food stuffs and other industrial applications~     however there is emerging evidence to show that lower molecular weight polysaccharides and~     oligosaccharides derived from these hydrocolloids can also act as a source of soluble fibre~     and may have prebiotic activity. Recent developments in Japan and Korea have lead to the~     commercial availability of products containing low molecular weight seaweed derived fibre.~     There is also some evidence for the beneficial effects of seaweed derived fibre in other key~     health areas such as cardiovascular health, cancer, diabetes and obesity. However,~     relatively little is known about the chemical, physio-chemical and fermentation~     characteristics of seaweed fibre in the human gut. Some hydrocolloids, notably guar gum~     (plant source), have also been employed for their health promoting properties in the areas~     of glucose tolerance and cholesterol lowering. However the use of hydrocolloids as~     functional food ingredients with health benefits for consumers has been rather limited and~     has focused more on uses in products for diabetics.~      It is particularly in the area of gut health that small and medium-sized enterprises (SMEs)~     involved in hydrocolloid production and processing, can enter the functional food~     ingredients market by using innovative processing technology. The total dietary fibre~     content of seaweed can be as high as 75% of the total dry weight and a high proportion of~     this is soluble. The fibre component essentially comprises the structural polysaccharides~     i.e. alginate and fucoidan in brown seaweeds, carrageenan, agar and porphyran in red~     seaweeds and ulvan in green seaweeds. As these fibres are primarily soluble, they form~     viscous gels as they pass through the gastrointestinal tract. Some of the fibre is fermented~     in the lower intestine but in general, soluble and insoluble seaweed fibre tends to pass~     through the gut without being digested. In its natural form as part of the seaweed plant,~     this fibre is typically high in molecular weight and passes through the gut too rapidly for~     the gut microflora to utilize it to any great extent. There is therefore a necessity to~     develop lower molecular weight forms that are more soluble and can be added at higher~     concentrations to food products without affecting the sensory properties of the product.~      The overall aim of the project is to realize an opportunity to produce low molecular weight~     polysaccharides (LMWP) from alginate- and agar-bearing seaweeds for applications in food &~     health. The two effective agar and alginate LMWPs, identified by in vitro studies, will be~     selected for assessment of prebiotic activity in a feeding trial in human volunteers (Ulster~     University) as part of an European Union (EU) study. The end points to be assessed will be~     stimulation of beneficial bacteria (bifidogenic effects), increased short chain fatty acid~     production, beneficial effects on stool formation, and improvements in gut barrier function.~     Additionally, benefits of the LMWPs towards blood glucose levels (short term and acute) will~     be assessed.~   "
34234|NCT02608970|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     BMS-986177 in healthy subjects~   "
34235|NCT02608957|"~     The objective of the Latella-US study is to demonstrate the safety and efficacy of the~     Latella Knee Implant System for the reduction of medial osteoarthritis pain.~   "
34236|NCT02608944|"~     This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative~     assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with~     quantitative PET imaging.~   "
34237|NCT02608931|"~     This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and~     vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or~     hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive~     disease in which the growth and development of selective nerves is impaired. Patients with~     FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing,~     tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have~     intolerable side sides. Our long-term goal is to treat nausea effectively and without side~     effects, a therapeutic intervention that would markedly improve the quality of life of~     patients with FD.~   "
34238|NCT02608918|"~     The purpose of the study is to assess the taste properties of HIV inhibitor~   "
34239|NCT02608905|"~     Sodium-glucose cotransporter 2 (SGLT-2) inhibitors reduce hyperglycemia and improve~     peripheral insulin sensitivity by ameliorating glucotoxicity. Insulin resistance in type 2~     diabetes (T2DM) is associated with endothelial dysfunction and vascular inflammation. Thus~     strategies to improve insulin sensitivity and lower glucotoxicity may improve endothelial~     inflammation and vascular inflammation. However, the effects of these agents on vascular~     inflammation and endothelial function is not known in patients with type 2 diabetes although~     anti-inflammatory properties have been demonstrated in various animal models. In the present~     study the investigators will assess if dapagliflozin treatment for 12 weeks decreases~     monocyte inflammation and improves endothelial function in patients with type 2 diabetes on~     metformin monotherapy.~   "
34275|NCT02608437|"~     Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit~     achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients.~     Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a~     direct activity on tumor growth as a single agent, SGI-110 was able to sensitize~     neoplastic cells to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific~     rationale to develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb~     to immune check-points.~   "
34276|NCT02608424|"~     In the present study, investigators test the hypothesis that a controlled mechanical~     pressure applied on specific sites of both fore-feet (ES) can reduce the inflammatory state~     and arterial blood pressure in patients with Parkinson's Disease by increasing the overall~     parasympathetic activity and reducing vascular sympathetic modulation.~   "
34240|NCT02608892|"~     Newborn infants have blood work procedures in their first days of life that cause pain,~     distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving~     sweet solutions (sucrose or glucose) has been shown to be effective for reducing babies'~     pain. However, recent studies of neonatal pain management practices demonstrate infrequent~     use of these strategies. There is a need for parent-targeted interventions, to support~     parents' involvement in comforting their infants during painful procedures. This pilot RCT~     will inform all aspects of a full-scale trial and will evaluate the effectiveness of the~     BSweet2Babies video when shown to parents of newborns prior to newborn screening, on~     subsequent use of effective pain reduction strategies during the newborn screening blood~     test. The participants will be randomized to either the control group (usual care), or to~     the intervention group and will be shown the brief BSweet2Babies video on caring for infants~     during blood work. The intervention group will be asked to complete a second survey after~     viewing the video. To evaluate the use of BF, SSC, or sucrose during newborn screening, the~     research assistant will collect data from the electronic medical record.~   "
34241|NCT02608879|"~     The purpose of this study is to determine the effects of a novel oral care protocol on the~     severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for~     head and neck cancers. The secondary objectives are to characterize the microbiome~     associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate~     other clinical indicators of the intervention. Participants will be enrolled prior to~     beginning radiation and/or chemotherapy, and will be randomized to receive either the oral~     health protocol or standard of care oral hygiene.~   "
34242|NCT02608866|"~     The investigators proposed this randomized study to determine the feasibility of delivering~     single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate~     their toxicity profiles. The investigators' analysis will provide robust data as well as~     predictive factors regarding the outcome after SSRS.~   "
34243|NCT02608853|"~     This study is conducted in the United States of America. The aim of this study is to~     estimate incidence rates of all malignant neoplasms, specific subgroups of malignant~     neoplasms, and acute pancreatitis among cohorts of antidiabetic drug users standardized to~     be representative of LEADER™ trial participants or liraglutide initiators within the~     Humedica Electronic Health Record (EHR) database.~   "
34244|NCT02608840|"~     This study will evaluate the ability of sounds played during slow wave sleep using a phase~     locked loop algorithm to enhance slow wave sleep and memory in cognitively healthy older~     adults and in those with amnestic mild cognitive impairment.~   "
34245|NCT02608827|"~     Hypertension is serious health problem in Brazil and affects almost 30%of adult population.~     It is known that there are pharmacologic and nonpharmacologic strategies for treating~     hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce~     blood pressure in an isolated form, but its combinations has never been studied. The aim of~     this study is to evaluate the association of both strategies and also the mechanisms~     involved in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.~   "
34246|NCT02608814|"~     Pleural infection is a potentially serious infection of the fluid normally found around the~     lung and current evidence suggests its incidence is increasing in both adult and paediatric~     populations.~      Identification of bacterial pathogens causing pleural infection is of paramount importance~     in the clinical care of patients are currently, only 40% of patients have a laboratory~     confirmed microbiological diagnosis for their pleural infection. An unclear diagnosis can be~     due to various reasons such as a small sample volume therefore the aim of the AUDIO study is~     to ascertain the capacity of pleural biopsies in improving the microbiological yield of~     pleural infection.~      Currently, there are no well validated methods for identifying patients presenting with~     pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define~     the role of baseline thoracic ultrasound in predicting the radiographic, clinical and~     surgical outcomes of patients with pleural infection.~      The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise~     and these patients will be followed up over a 12 month period. Investigators hope that~     through the information gathered from ultrasound imaging and pleural biopsies, it will aid~     physicians' clinical and therapeutic decision making when treating patients with pleural~     infection.~   "
34247|NCT02608801|"~     The purpose of this study is to investigate patient related factors that contribute to~     increased risk of recurrent fractures, to investigate patient adherence to prescribed~     anti-osteoporotic drugs and cost-utility analysis.~   "
34248|NCT02608788|"~     The purpose of intubation for patients under general anesthesia is to maintain their~     respiratory function. However, this procedure does cause a postoperative sore throat.~     Comfort of patients could be promoted if effective treatment could be found.~      The specific aims of this project are:~        1. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to~          Release Postoperative Sore Throat.~        2. Acular spray for the prevention of postoperative sore throat.~        3. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and~          Acular to Release Postoperative Sore Throat.~   "
34249|NCT02608775|"~     The primary objective of this study is to investigate the influence of a standardized~     noxious stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and~     sufentanil TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.~      In addition the investigators compare the performance of ANI and SPI against one another as~     well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.~   "
34277|NCT02608411|"~     This study aims to assess the role of MET inhibitors as maintenance treatment in adult~     patients with extensive stage small cell lung cancer.~   "
34302|NCT02608086|"~     Psychological First Aid (PFA) is currently the most recommended early intervention for~     people affected by recent traumatic events, especially in the aftermath of natural~     disasters. Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic~     Stress Disorder (PTSD) nor other post-traumatic disorders or symptoms of distress. This~     project aims to evaluate the efficacy and safety of Psychological First Aid for the~     prevention of PTSD and other post-traumatic disorders or symptoms.~   "
34848|NCT02600845|"~     This post-market, interventional, prospective, single arm, the United States (US) based~     multi-center study will assess the change in treatment satisfaction of participants who~     utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.~   "
34250|NCT02608762|"~     Background: Neurobehavioral functions and quality of life (QoL) are the important outcome~     measurements after radiotherapy in patients with brain tumors and even head/neck cancers.~     However, few studies have focused on neurobehavioral functions and QoL after anti-cancer~     treatment particularly brain radiotherapy for pediatric/adolescent patients with brain~     tumors. This study thus aims to prospectively evaluate those functions in pediatric or~     adolescent patients with brain or head/neck tumors in order to provide useful information~     about their clinical outcomes.~      Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or~     head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated~     using a neuropsychological battery, which includes general cognitive functions,~     intelligence, memory, executive functions, information processing and emotional/behavioral~     expressions. The QoL will be evaluated by the health-related QoL questionnaire. All~     participants will be examined at six phases, which include pre-treatment, 1-month~     post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and~     3-year post-treatment.~      Expected results: Patients'neurobehavioral functions and QoL will show significant~     improvement after treatment, and the improvement will not be diminished across each~     post-treatment phase.~   "
34251|NCT02608749|"~     BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on~     physical activity in older adults.~      METHODS: This was a randomized, parallel-group, prospective study. All participants received~     education program including home-based exercise. The IC group consisted of different~     modalities of exercise while the LEE group performed machine-based exercise. Body~     composition, muscle strength, and physical performance were measured at their baseline and 3~     months follow-up.~   "
34252|NCT02608736|"~     This study evaluates the addition of valproic acid as a chemopreventive drug in head and~     neck squamous cell carcinoma (HNSCC) patients that do not have signs of recurrence or~     residual disease. The participants will be randomized 1:1 (valproic acid : placebo). The~     primary outcome is to document histone acetylation and DNA methyltransferase expression~     (DNMT) in saliva collected from participants when comparing valproic acid arm with placebo~     arm.~   "
34253|NCT02608723|"~     To check in patients suffering from chronic plantar fasciitis treated with shock wave~     therapy, if the outward appearance of the device affects clinical outcomes.~   "
34254|NCT02608710|"~     The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of~     RDEA3170 when given as single or multiple doses~   "
34255|NCT02608697|"~     The purpose of this placebo-controlled, double-blind study is to assess the effect of~     several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of~     high-intensity statin, and to evaluate the safety and tolerability of different doses of~     CAT-2054 for 4 weeks.~   "
34256|NCT02608684|"~     To evaluate the efficacy and safety of anti-PD-1 antibody MK-3475 (pembrolizumab) in~     combination with gemcitabine and cisplatin chemotherapy in women with recurrent~     platinum-resistant ovarian cancer.~   "
34257|NCT02608671|"~     This study will be undertaken to question the superiority of use skin adhesive tape (®~     Steri-Strip) closure system in wound healing over the traditional running absorbable~     subcuticular suture technique in perineal repair after episiotomy.~   "
34258|NCT02608658|"~     This protocol represents an open-label pilot study to assess whether oral administration of~     SBI in subjects with decompensated cirrhosis with ascites can lead improvements in the~     management of the disease. The impact of SBI therapy will be based on changes to markers of~     bacterial translocation, gut barrier damage, and inflammation as well as the impact on rates~     of SIBO. Study subjects will be given one packet of EnteraGam, each packet containing 5.0 g~     SBI, twice daily for 8 weeks.~   "
34259|NCT02608645|"~     In this study, within the secondary prevention group patients ( diabetes mellitus, coronary~     artery disease, peripheral artery disease, who have had events atherosclerotic~     cerebrovascular ) , statin use requirement , patients compliance and reaching target~     LDL-cholesterol levels (according to European guidelines ) will be evaluated.~   "
34260|NCT02608632|"~     To increase the number of responders using HFS-guided renal artery denervation (RDN) in~     patients with resistant and moderate resistant hypertension~   "
34261|NCT02608619|"~     The main purpose of this study is to discover how 18F-cholineFCH distributes in the body,~     and see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor)~     cells. This tracer has the potential to give the investigators' team more information when~     trying to identify the tumor cells that are most important to collect with biopsy. In~     addition, the study will measure levels of 18F-cholineFCH in the biopsy tissue.~   "
34262|NCT02608606|"~     After liver transplantation one of the most important cost, for both patients and their~     health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is~     considered the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral~     administration is the usual route, however, sublingual (SL) administration has been recently~     reported. This method of administration avoids first pass metabolism and allows an~     alternative route after transplant surgery, particularly in those patients who should extend~     the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies,~     the dose of tacrolimus SL required to maintain similar plasma concentrations compared with~     oral administration, is significantly lower, even up to 50%, which can result in~     considerable savings in short and long term. Among these studies, only one was conducted in~     liver recipients. This study suggest that SL administration of tacrolimus could allow to~     obtain similar concentrations compared with oral administration. The design of this study~     did not assess the existence of differences in the dose required and only included six~     patients.~   "
34291|NCT02608229|"~     In light of the central role of extracellular signal-regulated kinases (ERK) in pancreatic~     cancer, the investigators propose a phase I study to evaluate the ERK inhibitor BVD-523 at~     the recommended phase 2 dose in combination with nab-paclitaxel plus gemcitabine in patients~     with newly diagnosed metastatic pancreatic cancer. The primary endpoint will be maximum~     tolerated dose (MTD) or RP2D and safety. The secondary endpoints include safety, response~     rate, biochemical response, progression-free survival (PFS) and overall survival (OS). The~     exploratory endpoints include the assessing the impact of BVD-523 on the MEK/ERK pathway and~     other major pathway pertain to pancreatic cancer.~   "
34263|NCT02608593|"~     Approximately 4,000 women undergo a mastectomy for breast cancer each year in the UK and~     around 1,500 will have an immediate breast reconstruction. Approximately half of these~     ladies will have an implant-based breast reconstruction, of which many have an~     implant-assisted breast reconstruction with an Acellular Dermal Matrix.~      Strattice™ is an Acellular Dermal Matrix (a pig skin product) made by Acelity. It is used to~     cover and disguise the lower part of the breast implant. Acellular Dermal Matrices have only~     been widely used for the last eight years and long-term outcomes for women who have had this~     form of reconstruction are lacking. Despite this, it is one of the most commonly offered~     methods of breast reconstruction in the UK for both ladies with a diagnosis of breast cancer~     and in the risk-reduction setting.~      The objective of this study is to assess long-term outcomes of Strattice™-based breast~     reconstructions in multiple Breast Surgery Centres across the UK. This will be a~     case-control study comparing women who have had an immediate implant-based breast~     reconstruction with Strattice™ (case) or without (control). This will be achieved by review~     and analysis of retrospective data from patients who have undergone immediate breast~     reconstruction using implants with or without Strattice™ following either a diagnosis breast~     cancer or for risk-reduction. In addition there will be a prospective clinical assessment of~     the reconstruction outcomes. Outcomes assessed will include complications, surgical~     re-interventions and aesthetic results. These will be related to co-morbid conditions and~     other risk factors. Data will also be collected on unplanned interventions associated with a~     cost, if available.~   "
34264|NCT02608580|"~     Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.The anomaly~     has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood~     cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility~     to infections.~      Patients with this disease should be monitored medically continuously from birth. At~     adulthood, they will pass from a pediatric medical care system to an adult medical care~     system.This transition can be experienced with more or less ease, depending on the~     organization within the pediatric and adult hospitals.~      This questionnaire aims to assess the quality of the transition between pediatric and adult~     services.The investigators want to better estimate hospital work and improve the quality of~     care for this type of patients, throughout their entire medical history.~   "
34265|NCT02608567|"~     In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left~     ventricular (LV) ejection fraction is well known. Consequently, there is class I indication~     for surgery in these patients when LV ejection fraction <50%. However, there is growing~     evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal~     myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection~     is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV~     global longitudinal strain, as assessed using speckle tracking imaging with transthoracic~     echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and~     thus, to improve the risk stratification, the management and the timing of surgery. Several~     mono-centric observational small studies recently reported results emphasizing the role of~     LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted~     and may provide meaningful data. The investigators hypothesized that LV global longitudinal~     strain is a determinant of outcome in asymptomatic patients with AS and preserved LV~     ejection fraction.~   "
34266|NCT02608554|"~     The present study is a randomized controlled trial, overweight/obese adolescent and young~     PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile~     and metabolic profile will be determined.~   "
34267|NCT02608541|"~     An observational study to derive clinically relevant and predictive rib fracture~     classification systems, based on retrospective and prospective cohorts, incorporating~     assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation~   "
34268|NCT02608528|"~     Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.~      Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with~     clinical markers of response. PET/CT tumor metabolic response will also be correlated will~     to progression-free survival and overall survival.~   "
34269|NCT02608515|"~     This non-interventional retrospective chart review study aims to evaluate the clinical~     outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at~     1st relapse and the treatment patterns following progressive disease as part of the routine~     clinical practice in Greece.~   "
34270|NCT02608502|"~     The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of~     135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated~     lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.~   "
34271|NCT02608489|"~     The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are~     effective and safe in the treatment of patients with dry eye after cataract surgery.~   "
34272|NCT02608476|"~     The primary objective of this study is to determine the safety and efficacy of CB-03-01~     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial~     acne vulgaris.~   "
34273|NCT02608463|"~     Neuropathic pain is a common pain disorder that is caused by problems in the nervous system.~     It affects more women than men and commonly occurs in pregnancy. Physicians have little~     information to guide their treatment of neuropathic pain in pregnancy. The overall goal of~     this study is to define the course, management, and pregnancy outcomes of neuropathic pain~     in pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in~     pregnancy as treatment options must minimize their risk to the unborn child as they have a~     direct effect on infant outcomes through their exposure in utero. Thus, other treatments are~     needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative~     to medications. Transcranial magnetic stimulation uses a magnetic force to change the way~     nerves work in the brain. This non-invasive and localized mechanism of action makes it~     attractive for use in special populations, such as pregnancy. This will be the first study~     to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study~     will enroll 60 pregnant subjects between the ages of 18 and 45. Participation in the study~     will last about 15 months with study visits about once a month. All participants will~     receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as~     a treatment option.~   "
34278|NCT02608398|"~     Aim:~        -  The overall aims of this study to look at what changes are seen overweight and obese~          (very overweight) children, as they get thinner.~        -  Specifically the investigators are interested in the chemicals and bacteria that~          children pass in their urine and stool because looking at how these change as it tells~          us about how their gut and other bodily systems are adapting.~      Hypothesis: Metabolic profiling is a useful and accurate tool for observing and monitoring~     weight loss in children~      Study plan:~        -  To observe this weight loss process in children, the investigators will be attending a~          commercial weight loss camp called 'MORElife' which takes place every year in Leeds.~          This camp is attended by children age 8-17years who are overweight or obese, for~          between two and five weeks. It aims to help them lose weight through a structured diet,~          exercise, education and support program.~        -  The investigators plan to, with the consent of the parent and agreement the child ask~          if they would kindly give us a urine sample at the beginning and end of their time on~          the camp. For those staying longer than 2 weeks the investigators will also ask for a~          sample in the middle if possible.~        -  In addition for those children who consent, the investigators will also ask for a small~          stool (poo) sample at these same time points although there is no obligation to~          participate at all in the study and it will not affect their time on the camp whatever~          they decide.~        -  Any children who will be attending the MORElife reunion (arranged by the camp at around~          10-12 months after) who agree will be asked for a final urine and stool sample to look~          at the long-term effects.~        -  Each sample is given a code so as to remain anonymous, frozen and transported to the~          university laboratory to be analyzed.~        -  With permission and consent the investigators will also collect some information about~          the children such as, weight and height from the camp coordinators as well as samples~          of the diet that they will be fed and example of exercise activities to give a full~          picture so that results can be as accurate as possible.~   "
34279|NCT02608385|"~     Objective:~      To determine the recommended SBRT dose to various metastatic locations in patients with~     advanced solid tumors, and specifically in the lung in patients with NSCLC, in conjunction~     with pembrolizumab treatment.~   "
34280|NCT02608372|"~     The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted~     participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds,~     Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to~     investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve~     (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin,~     glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma~     as well as subjective satiety are also analyzed.~   "
34281|NCT02608359|"~     The purpose of this study is to evaluate the safety of abiraterone acetate in Indian~     participants with metastatic, castration-resistant prostate cancer who have been prescribed~     abiraterone acetate as per locally approved prescribing information.~   "
34282|NCT02608346|"~     BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer~     growth will be included. These patients will be followed up during 30 months (2, 5 years)~     with mutated TP53 mutation detection performed at each hospital visit.~   "
34283|NCT02608333|"~     Intervention for autism spectrum disorder (ASD) in European French-speaking countries is~     often heterogeneous and poorly evaluated. Six French-speaking early intervention units for~     children with ASD following the Early Start Denver Model (ESDM) have been created since 2011~     with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the~     European French-speaking public health system. In those units, Children receive ESDM at~     minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at~     home) and preschool or nursery.~      The first aim of the investigators study is to evaluate the effectiveness of ESDM~     intervention 12 hours per week during 2 years on the global development of children with ASD~     compared to the interventions commonly available in the community.~   "
34284|NCT02608320|"~     The purpose of this study is to evaluate the cumulative adhesion percentage for the test~     products and the reference products for both small and large patches.~   "
34285|NCT02608307|"~     In the setting of progressive or recurrent cancer, adolescent and young adult (AYA)~     patients, parents, and healthcare providers (HCP) are faced with multiple therapeutic~     options. Each treatment option has a unique risk/benefit ratio, resulting in a need to trade~     one desirable outcome for another or accept acute toxicities and treatment-related morbidity~     to increase the chance of survival. Adding to the complexity of this decision, stake holders~     characterize and value the risk/benefit ratios differently.~      This study seeks to learn what things are important to an adolescent or young adult with~     cancer, parents, and health care providers when making decisions about their treatment~     choices.~      PRIMARY OBJECTIVE: To quantify the relative importance of various factors believed to be~     important to adolescent and young adult patients with cancer, parents, and health care~     providers when choosing between treatment options in the hypothetical situation of~     progressive or refractory disease.~   "
34286|NCT02608294|"~     A pilot study was conducted, randomized, triple-blind study with allocation concealment.~     Which consisted in the application of KT in the anterior tibial muscle for 24 hours. 14~     subjects were randomized into 2 groups: intervention (with voltage) and sham (no pressure).~     Patient's gait footage was shot in the opening balance of phases, average balance and~     initial contact (first without the application of Kinesio Taping and after 24 hours of~     application) to be measured the angles of the ankle joints, knee and hip. Balance was~     assessed by the Biodex Balance System platform, configured to analyze the postural stability~     in level eight. The mean differences were assessed (MD) between groups and confidence~     interval (CI) of 95%.~   "
34287|NCT02608281|"~     Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy~     mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this~     clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast~     Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be~     compared for both modalities.~   "
34288|NCT02608268|"~     The purpose of this first-in-human study of MBG453 is to characterize the safety,~     tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453~     administered i.v. as a single agent or in combination with PDR001 in adult patients with~     advanced solid tumors~   "
34289|NCT02608255|"~     A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement~     will be performed and compared to troponin µs for early triage of these patients. This novel~     biomarker of myocardial ischemia (CD26) will be measured at the time of first medical~     contact (T0) and after 30 min simultaneously o troponin Ic.~      All patients aged over 18 years with chest pain which may be related to acute coronary~     syndrome requiring pre hospital medical contact through the Emergency Medical Service.~   "
34290|NCT02608242|"~     This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover~     design.~   "
34292|NCT02608216|"~     In this study positron emission tomography (PET/CT) imaging will be used to evaluate~     proliferative activity in sites of metastatic disease using the investigational radiotracer~     [18F]fluorothymidine (FLT).~   "
34293|NCT02608203|"~     Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by~     radiolabeled somatostatin-analogs.~      During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named~     somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear~     imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this~     clinical setting because of the low intrinsic resolution of the technique and its~     selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion~     analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher~     sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.~      In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive~     technology, has gained an increasing role in oncology. It has also been evaluated in~     GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron~     emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS~     and many European centers have already replaced SRS by [68Ga]-PET-SSTa.~      Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC,~     DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM,~     respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.~      [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more~     lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but~     this requires further evaluation.~      It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the~     standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding~     [68Ga]-DOTANOC in the work-up of patients.~      The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least~     20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison~     to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and~     SRS).~      110 patients will be included prospectively in 5 different French experienced centers~     (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).~   "
34294|NCT02608190|"~     Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right~     hemisphere of the brain and the parietal cortex in particular, is common and results in a~     disorder known as 'neglect' in 40% to 95% of patients. These patients fail to attend to or~     respond to events occurring in left space; the disorder is devastating for the patient and~     their caregivers with the patient becoming dependent on assistance for most activities of~     daily life (ADLs).~      The project will implement two visual working memory (VWM) training programs to explore the~     influence of VWM training on neglect symptoms as well as activities of daily life.~      Hypothesis: It is hypothesised that SWM training protocols will lead to improvements of~     neglect symptoms as well as improvement in ADLs.~      The project will develop a novel rehabilitation strategy for treating the neglect syndrome.~      Evidence from research in healthy participants employing video games to improve cognition~     along with research using working memory training protocols showing a broad range of~     benefits accruing to both trained and untrained tasks, suggests that the investigators~     approach has great potential to improve the core deficits of the neglect syndrome. Thus, WM~     training represents a promising avenue for rehabilitating neglect patients who demonstrate~     core deficits in both spatial attention and VWM to be highly interrelated functions.~   "
34295|NCT02608177|"~     The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with~     a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose~     variability. Blood glucose is measured using a continuous glucose monitoring device.~   "
34296|NCT02608164|"~     The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution~     with capsules at raising vitamin D status over winter.~      This randomised crossover trial will aim to recruit a total of 22 healthy participants for a~     total of two 4-week interventions separated by a 10-week washout.~   "
34297|NCT02608151|"~     Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage~     pressure with kinesthetic movement significantly increases the weight, bone density and~     shorten the duration of stay of premature babies who benefits.~      Studies using vegetable oils show an increase in the effect on weight gain by cutaneous~     absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin~     mechanoreceptors) since it is found in children stimulated an increase in the vagal~     activity, acceleration of gastric emptying and an increase in the secretion of insulin and~     IGF1.~      Few studies have evaluated the effects of massage on the medium-term neurological~     development in preterm infants and the effect of the essential oils in the effectiveness of~     touching the short and medium term massage.~      The aim of the investigators study is to evaluate the neurological development in the short~     and medium term in premature newborns and biological effects of massage with essential use~     of vegetable oil.~      Methodology and possible collaborations This is a monocentric, randomized, controlled, in a~     neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of~     amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment~     is administered 10 minutes twice a day for 10 consecutive days watching for signs of~     intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age~     corrected is used as the first neurological assessment criterion.~      The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.)~     is used to 6, 12, 24 months corrected age and completed by the parents as a second~     neurological endpoint.~      A lipid chromatography is performed at the beginning and at the end of the massage time and~     at the deliverance from NICU for comparing the profile of children's fatty acids.~      Expected results Show that there is an improvement in the neurological development in~     children who received massage with vegetable oil ISIO 4. Show that there is a skin~     absorption of essential fatty acids that can substitute for a known major deficiency in~     premature even in infants fed breast milk.~   "
34298|NCT02608138|"~     It is well known that insufficient iodine intakes impairs the production of thyroid~     hormones, essential for cognitive development and healthy growth.~      Although the World Health Organization (WHO) promotes public health measures for an adequate~     iodine consumption, it is estimated that one in three school age children remain iodine~     deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young~     infants are among the most vulnerable to iodine deficiency due to their special~     requirements.~      Therefore, the present study aims to evaluate iodine status in school age Portuguese~     children (6-12y), compare iodine status in children, cognitive outcomes and thyroid health~     and monitor the use of iodised salt in school canteens exploring potential implications in~     children's iodine status.~   "
34299|NCT02608125|"~     This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two~     parts, Part A, and Part B. Part A is the dose escalation phase for evaluating the safety and~     tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion~     phase to further evaluate safety and tolerability, preliminary activity, PK, and PD in~     patients with FGFR genetic alterations.~   "
34300|NCT02608112|"~     This multicenter, prospective, non-interventional study is designed to obtain an accurate~     estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under~     real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).~   "
34301|NCT02608099|"~     The purpose of the prospective, randomized cohort in this study is to assess the safety and~     efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects~     planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation~     (NVAF).~      Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by~     chart review, who are matched to the prospective randomized subjects, will be identified.~     The purpose of the retrospective warfarin cohort is to compare the efficacy and safety of~     warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted,~     combined uninterrupted and interrupted).~   "
34303|NCT02608073|"~     This study will evaluate the efficacy, safety, tolerability, and effect on quality of life~     of oral capecitabine in combination with intravenous (IV) cisplatin in participants with~     metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine~     treatment, and cisplatin will be administered on the first day of each cycle. The~     anticipated time on study treatment is up to 24 weeks, and the target sample size is 44~     individuals.~   "
34304|NCT02608060|"~     This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly~     subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with~     non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated~     study duration is 4 months, and the target sample size is 30 individuals.~   "
34305|NCT02608047|"~     The purpose of this study is to elucidate the local epidemic problem and epidemiological~     characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and~     clinical treatment system of severe cases to reduce the morbidity and mortality of dengue~     fever.~   "
34306|NCT02608034|"~     This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to~     investigate the effect of itraconazole and rifampin on the PK of vemurafenib following~     multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with~     unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation,~     or other malignant tumor types that harbor a V600-activating mutation of BRAF where the~     participant has no acceptable standard treatment options.~   "
34307|NCT02608021|"~     This protocol describes a study to validate Neurotrack's visual paired comparison task,~     aimed at early detection and monitoring of memory impairment. The investigators will~     determine whether the novel task developed by Neurotrack is associated with markers of brain~     pathology associated with very early Alzheimer's disease. The elderly subjects studied will~     be cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the~     current study, the primary brain pathology parameters will be derived from MRI scans. Data~     from this study will be correlated with data from a parallel study designed to validate a~     larger group of new cognitive tasks by correlating test performance with a broader array of~     biomarkers of Alzheimer's disease.~   "
34308|NCT02608008|"~     The purpose of this study is to collect data regarding the safety and efficacy of~     EchoNavigator System Release II during structural heart interventions in the clinical~     practice. Data of procedures with and without the use of EchoNavigator System Release II~     will be collected, analysed and evaluated.~   "
34309|NCT02607995|"~     Obesity occurs more frequently in subjects of a lower socioeconomic status and is associated~     with a lower income and unemployment. On the other hand, there is limited access of~     individuals with low socioeconomic status to conventional obesity treatments and bariatric~     surgery.~      In STEREOplus the investigators will ascertain unemployed adolescents with obesity and~     extreme obesity at five job centers in the Ruhr area. Unemployed obese youths and young~     adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years are eligible to participate.~     Participants will be asked to complete a series of questionnaires on their general health,~     psychosocial situation and wellbeing, and will be offered a thorough medical evaluation.~     Individuals who complete the baseline evaluations will be invited to participate in six~     group sessions of conventional obesity treatment over a three months period. After six~     months, participants will complete further questionnaires to evaluate the effects of the~     interventions on quality of life and psychosocial functioning. Weight status (BMI) will also~     be measured. Adolescents who attended at least five sessions and are interested in bariatric~     surgery will have access to a structured information and preparation program for bariatric~     surgery.~      The overall objective of STEREOplus is to generate data on the feasibility of the planned~     implementation of a treatment targeted to a high risk group with a low socioeconomic~     background in order to reduce treatment barriers.~   "
34310|NCT02607982|"~     This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy~     (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced~     esophageal cancer patients.~   "
34311|NCT02607969|"~     30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis~     will be the participants of the study.~      The subjects will randomly allocated into the two home program groups; first home program~     group was seen once every six weeks (SxW), second home program group was seen once a week~     (OW).~      Parents will educate about the same home program which consisted of positioning the neck and~     head, sleep in alternating head positions and in side-laying to increase head shape symmetry~     and place infants, when awake and under supervision, regularly in the prone position a day~     to stimulate normal motor development (tummy time), decreasing the time spent in car seat at~     supine position. Environmental settings also will be given to challenge the baby look~     through from the side no flattening to room, place colorful and sonorous toys or mirror on~     the opposite of the flattening side, and stimulate active rotation by communicating with~     baby from this side. Handling strategies, stretching and strengthening exercises will be~     given for CMT. The parents will be reinforme if necessary. Positioning strategies will~     spread throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5~     subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial~     asymmetry, ear asymmetry will be used to evaluate severity of DP.~   "
34312|NCT02607956|"~     This study will evaluate the efficacy of a fixed dose combination (FDC) containing~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC~     containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral~     treatment-naive adults at Week 48.~   "
34313|NCT02607943|"~     Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to~     control hyperglycemia during acute ischemic stroke has not been established. The object of~     this multicenter randomized controlled study is to determine the efficacy and safety of~     early initiation of subcutaneous once-daily insulin glargine, in comparison with regular~     insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in~     acute stroke patients with hyperglycemia admitted to the intensive care unit.~   "
34314|NCT02607930|"~     The study will evaluate the efficacy of a fixed dose combination (FDC) containing~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment~     naive-adults.~   "
34315|NCT02607917|"~     This research will test the effect of mass media or mass media plus a clinic based education~     program will improve appropriate aspirin use for cardiovascular disease prevention. It is a~     group randomized design of 24 geographic areas in Minnesota with adjacent states serving as~     controls.~   "
34316|NCT02607904|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
34317|NCT02607891|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The blinded phase only will be described in this record. Participants will be randomized in~     a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of~     stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of~     using GWP42003-P.~   "
34318|NCT02607878|"~     Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might~     reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA).~     Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly~     improve prognostication of post-CA coma, however, EEG and SSEP are not always available and~     require specific expertise for their interpretation. Automated video pupillometry is a novel~     electronic device that contains an infrared light camera which enables to measure~     quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a~     recent study of a cohort of comatose CA survivors (n=50 patients) it was found that~     quantitative PLR was more accurate than standard PLR (manual pen light) in predicting~     3-month outcome, irrespective of temperature and sedation, and had comparable prognostic~     accuracy than electrophysiological exams, including electroencephalography (EEG) and~     somato-sensory evoked potentials (SSEP).~      Aim of the study: In light of these promising results, the investigators would like to~     confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose~     post-CA patients.~      Design of the study: Prospective, multicenter, observational outcome trial.~   "
34319|NCT02607865|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and~     long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.~   "
34320|NCT02607852|"~     The primary objective of the overall study is to determine the feasibility and usefulness of~     a feedback system that delivers BOQ results to physicians in real time during patient~     visits using iPads.~   "
34321|NCT02607839|"~     The purpose of study is to examine whether raised blood glucose enhances lipid particle~     production independent of effects on gastric emptying and pancreatic/ gastrointestinal~     hormone production.~   "
34322|NCT02607826|"~     Recent pre-clinical data provide strong evidence that short-term starvation before the~     administration of cytostatic drugs for the chemotherapy of solid tumors leads to~     significantly higher efficacy and lower toxicity levels. However, these findings have so far~     not been validated in patients. The aim of this trial is to provide first clinical evidence~     regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy~     (primary endpoint). Additionally, progression-free survival, adverse events, and overall~     survival will be monitored (secondary endpoints). In perspective, short-term starvation~     before chemotherapy could represent a simple and secure way to improve both efficacy and~     tolerance of chemotherapies at low cost.~   "
34323|NCT02607813|"~     A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway~     Alterations.~   "
34324|NCT02607800|"~     This study will evaluate the safety and efficacy of treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and SOF/VEL in adults with chronic HCV~     infection who have not previously received treatment with direct-acting antiviral therapy.~   "
34325|NCT02607787|"~     The aim of this study is to assess the feasibility and effectiveness of a home-based walking~     and strengthening intervention on physiological, biochemical and psychological outcomes in~     colo-rectal cancer survivors.~      The intervention consists of a 12-week home-based walking and strengthening programme for~     colo-rectal cancer survivors post any anti-cancer treatment. It aims to gradually increase~     participants physical activity levels so that they start achieving the recommended levels of~     at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise~     for all major muscle groups at least twice per week.~      As well as usual care, the intervention group will receive weekly telephone calls and a~     behaviour change interview at baseline. Participants will be recruited from the Cancer~     Centre at the Belfast City Hospital. Assessments will be taken at baseline (0 weeks), post~     intervention (12 weeks) and also at a 3-month follow-up (24 weeks). The control group will~     receive the same assessments at the same time-points however they will continue to receive~     usual care with the intervention information (including pedometer, exercise booklet, diary~     and behavioural change interview) being given at the 3-month follow-up appointment.~   "
34326|NCT02607774|"~     To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using~     midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.~   "
34327|NCT02607761|"~     Recent evidence showed that undergraduate students have inappropriate knowledge about~     reproductive health and infertility.~      The investigators' aim was to assess the effectiveness of a brief intervention (video) in~     increasing the knowledge regarding fertility issues, fertility risk factors and infertility~     definition.~   "
34328|NCT02607748|"~     The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission~     Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to~     non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition~     intravascular ultrasound (IVUS).~      In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan~     reproducibility.~   "
34329|NCT02607735|"~     This study will evaluate the safety and efficacy of treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic HCV infection who~     have previously received treatment with direct-acting antiviral therapy.~      Subjects randomized to placebo may be eligible for deferred treatment with active~     SOF/VEL/VOX.~   "
34339|NCT02607605|"~     The primary purpose of this study is to compare the positive rate between the cell-free DNA~     and cytological examination of cerebrospinal fluid in Advanced lung cancer with~     leptomeningeal metastases.~   "
34330|NCT02607722|"~     This is a non-interventional study based on new data collection to gather real-world~     information (i.e., data under routine medical practice) on safety and effectiveness of the~     Ofev® Capsules treatment.~      The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52,~     65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will~     be followed up until discontinuation of Ofev® Capsules treatment.~      As this is an observational study, no specific treatment is mandated or withheld from the~     patients. The choice of maintenance treatment for IPF must be according to regular medical~     practice and at the discretion of the physician (i.e., no randomised assignment of patient~     to treatment is performed).~      All patients administrated Ofev® Capsules after the launch at the sites contracted with the~     sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected.~     However the patient registration continues until the approval condition has been removed.~      Patients participating in the subsequent follow-up will undergo regular observations. These~     observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and~     104 since the initiation of Ofev® Capsules as long as they continue to receive the~     treatment. Patients will not be followed any longer once they are reported to have~     discontinued the Ofev® Capsules treatment.~   "
34331|NCT02607709|"~     Two out of three tumours in the upper urinary tract are located in the renal pelvis.~     Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper~     urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours~     represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the~     urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive~     disease. Information regarding indications, extent and possible curative potential is~     currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial~     carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with~     survival data for patients with lymph node metastasis that report long term survival after~     surgery as monotherapy [4] with similar survival proportions as in bladder cancer with lymph~     node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to~     the only available prospective study, where 68 patients with UUTUC were submitted to~     template-based lymphadenectomy. Another retrospective study by the same Japanese group,~     showed that 5-year cancer-specific and recurrence-free survival was significantly higher in~     the complete lymphadenectomy group than in the incomplete lymphadenectomy or without~     lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy~     without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.~   "
34332|NCT02607696|"~     This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics~     of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample~     size is 48 participants, male or female, aged above 18 years-old.~      Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two~     different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and~     tolerability of the investigational product.~      Participants will be admitted for a period of 36 hours, when investigational product will be~     administered, and blood samples, at pre-determined time periods, will be collected for~     pharmacokinetics.~      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be~     assessed by adverse events occurrence and laboratory exams evaluation.~   "
34333|NCT02607683|"~     This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the~     efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid~     steatoblepharon (undereye bags).~   "
34334|NCT02607670|"~     This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the~     reduction of moderate to severe nasolabial folds.~   "
34335|NCT02607657|"~     This is a Phase I, open-label, randomized, parallel trial to evaluate the pharmacokinetics~     of Eplerenone tablet at different dosages (25 mg once daily, 50 mg once daily, 100 mg (2~     tablets of 50 mg) once daily and 50 mg twice daily). Sample size is 96 participants (24 per~     treatment group), male or female, aged between 18 and 50 years-old.~      Primary objective is to evaluate pharmacokinetics of Eplerenone tablet at different dosages,~     and secondary objective is to evaluate safety and tolerability of the investigational~     product.~      Study overall duration is approximately 12 weeks, including enrollment and follow-up visits.~     Participants will be admitted for a period of 36 hours, when investigational product will be~     administered, and blood samples, at pre-determined time periods, will be collected for~     pharmacokinetics.~      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be~     assessed by adverse events occurrence and laboratory exams evaluation.~   "
34336|NCT02607644|"~     Introduction: The laryngeal mask airway (LMA) is used as the primary airway by paramedics in~     Singapore Civil Defense Force's Emergency Ambulance Service (SCDF's EAS) in the management~     of out-of-hospital cardiac arrest, because endotracheal intubation requires skilled and~     experienced personnel, and local paramedics are not trained to this level of skill and~     competency. However, self-reported insertion success rates by paramedics in the field are~     currently only about 50-87%. Devices like the laryngeal tube have been shown to have higher~     placement success rates and fewer complications.~      Aim: Investigators aim to evaluate the efficacy and safety of a new device, the Laryngeal~     Tube (LT), compared to the LMA. They hypothesize that the LT is superior to the LMA in terms~     of placement success rates by paramedics in SCDF's EAS, and is associated with fewer adverse~     events.~      Methodology: Investigators propose to conduct a prospective, longitudinal multi-centre~     randomized trial comparing LMA and LT in patients with cardiac arrest (medical or traumatic)~     managed by SCDF EAS. The trial will recruit 875 eligible patients presenting to SCDF~     irrespective of destination hospital over a period of 1 year to detect an expected 15%~     difference in placement success rate. Currently the LMA is used as standard of care by~     SCDF's EAS in patients with cardiac arrest.~      Results: Besides the primary outcome, the secondary outcomes of dislodgment rates, time to~     placement, number of attempts and adverse events will be analyzed and will be useful in~     guiding future SCDF cardiac arrest protocols.~   "
34337|NCT02607631|"~     This is a Phase II single center, open-label, single arm study in patients with advanced~     thymic epithelial tumors after failure of cisplatin-based combination chemotherapy. Patients~     will be treated with Pembrolizumab 200 mg every 3 weeks.~   "
34338|NCT02607618|"~     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim~     compared to vancomycin for the treatment of skin and skin structure infections.~   "
34341|NCT02607579|"~     The purpose of this prospective study is to examine the effect of two local anesthetics used~     in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain~     related interference with activities and hospital length of stay. The two agents are~     bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these~     drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility,~     and pain related interference with activities and hospital length of stay.~   "
34342|NCT02607566|"~     This study will examine the feasibility and acceptability of a twice weekly yoga program for~     adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will~     also be examined.~   "
34343|NCT02607553|"~     An open-label, single-arm, single-center Phase II study to evaluate the safety and activity~     of G-202 in patients with clear cell renal cell carcinoma that expresses PSMA~   "
34344|NCT02607540|"~     A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with~     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But~     in China because of its toxic reaction, most of patients stop the halfway.~      The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus~     5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A~     total of 210 patients will be accrued from China within 2 years. The primary endpoint is~     overall survival and the secondary endpoints include progression-free survival, response~     rate, pathologic complete response rate and adverse events.~   "
34345|NCT02607527|"~     Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral~     regurgitation in subjects determined appropriate for mitral valve surgery.~   "
34346|NCT02607514|"~     Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy,~     and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically~     healthy adults with mild to moderate depressive symptoms. The primary aim is to test the~     acceptability and feasibility of hyperthermic yoga as a treatment for depression. The~     secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive~     symptoms. The tertiary aim is to explore physiological and psychological mechanisms of~     action.~   "
34347|NCT02607501|"~     An open label, prospective, multicentre, single-arm, post marketing study evaluating the~     safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the~     treatment of bifurcation intracranial aneurysms.~   "
34348|NCT02607488|"~     Increasing rates of obesity over the last few decades have led to growing demand for~     bariatric surgery, which may resulted in decreased comorbidities and improved patient~     outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved~     quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function,~     less immune suppression, and shortened duration of hospital stay than open laparotomies.~      Some investigators reported delayed return of bowel function for approximately two days~     after laparoscopic bariatric surgery, despite it occurred one day earlier than after open~     laparotomy. This potentially can lengthen the duration of hospital stay after bariatric~     procedures. With the impeding cost of health care in the developing countries, safely~     reducing length of stay is essential.~      Other investigators reported early return of bowel movements during the first postoperative~     day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced~     morphine use with implementation of a multimodal analgesia strategy including ketorolac, and~     propoxyphene hydrochloride/acetaminophen.~      Lidocaine was investigated in several studies for its use in multi-modal management~     strategies to reduce postoperative pain and opioid use and enhance recovery. A recent~     Cochrane review including 45 trials demonstrated that systemic administration of lidocaine~     was associated with reduced pain scores at most of 'early time points' in patients~     undergoing laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality~     evidence), shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality~     evidence) and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality~     evidence), and less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99;~     low-quality evidence). However, no evidence of effect was found for lidocaine on shortening~     the time to first defecation. This low-quality evidence may be related to the heterogeneity~     between the studies in respect to the optimal dose, timing and duration of the~     administration of intravenous lidocaine.~   "
34349|NCT02607475|"~     Robotic telesonography, in which an expert remotely performs sonography in real time, has~     recently emerged as an opportunity to perform sonography at remote centres. Using a robotic~     system and an assistant with limited training at the remote site, an expert can manipulate~     an ultrasound probe and generate images in real-time via an Internet connection. This study~     aims to demonstrate the feasibility of robotic telesonography for obstetric and adult and~     pediatric abdominal imaging in a centre with established sonography services which will be~     used as a comparator to robotic telesonography.~   "
34350|NCT02607462|"~     Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total~     hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study~     using saline as placebo. The measurement outcomes includes objective variables (MRI,~     dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score).~      Patients are assigned to two different groups, according to a randomization list. PRP~     (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of~     platelet count) is obtained from venous blood and applied to m. gluteus medius during the~     closure of modified lateral approach (Hardinge).~      Study participants are evaluated preoperatively by trained physiotherapist. After surgery,~     participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative.~     In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the~     study, the nature of the injected substance is revealed to the patients.~   "
34351|NCT02607449|"~     Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and~     development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with~     the high burden of tuberculosis, The Government of The Republic of Kazakhstan has founded~     initiative on the development of new Anti-TB drug to treat drug-resistant forms of this~     infectious disease. JSC Scientific Center for Anti-infectious Drugs has developed original~     drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).~   "
34352|NCT02607436|"~     This is a prospective interventional study to assess the effect of sarpogrelate compared~     with aspirin in Korean type 2 diabetic patients with atherosclerosis.~   "
34353|NCT02607423|"~     This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission~     tomography (PET)/computed tomography (CT) works in predicting response to chemotherapy in~     patients with stage IIIA non-small cell lung cancer that can be removed by surgery~     (resectable). Performing diagnostic procedures, such as fludeoxyglucose F-18 PET/CT, after~     one course of chemotherapy may help doctors predict a patient's response to treatment~     earlier and help plan the best treatment.~   "
34355|NCT02607397|"~     The cost of particle therapy (PT) are considerably higher than conventional radiotherapy~     (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to~     determine if PT are more cost-effective than photons per indication regarding quality of~     life, survival, and progression free survival. Given the lack of evidence for the benefit of~     particle therapy in relevant cases, investigators proposed an in silico trial to investigate~     to what extend proton therapy decrease the amount of irradiated normal tissue and,~     consequently, the risk of side effects in the surrounding normal tissue as well as the risk~     of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower~     mean dose of proton therapy on normal tissue compared to photon therapy should result in at~     least a 20% lower risk of side effects.~   "
34356|NCT02607384|"~     The Baltimore Reading and Eye Disease Study (BREDS) is a two year study to determine the~     prevalence of vision problems in an early school age population with reading difficulty.~     Comprehensive vision and reading tests will be administered to 400 students at participating~     schools in the Baltimore City Public School system.~      A secondary goal is to examine the impact of vision treatment on reading performance.~     Children with refractive error or convergence insufficiency will be provided treatment free~     of charge. The investigators will evaluate the impact that the treatment has on vision~     function and reading performance.~   "
34357|NCT02607371|"~     The main research question of this patient survey is to assess AF (Atrial Fibrillation)~     patients' preferences associated with different attributes which describe the different~     available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral~     Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or~     Rivaroxaban).~      VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.~   "
34358|NCT02607358|"~     Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in~     acute ischemic stroke patients.~   "
34359|NCT02607345|"~     Objective: to compare blood glucose and insulin responses after consumption of 100ml water,~     sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)~   "
34360|NCT02607332|"~     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib~     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients~     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib~     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure~     with imatinib. However, virtually all patients will eventually progress or become~     intolerable after the first-line imatinib and the second-line sunitinib.~   "
34361|NCT02607319|"~     The objective of this study is to determine the effect of Bemiparin, a low molecular weight~     heparin, on implantation rate in women with unexplained recurrent implantation failure~     undergoing IVF/ICSI treatment.~   "
34362|NCT02607306|"~     This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety~     of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with~     type 2 diabetes mellitus.~   "
34363|NCT02607293|"~     This is a Phase IV, prospective, observational, single arm, multicenter trial to identify~     the population at high risk of overstimulation associated with signs and symptoms of PCOS~     and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for~     individualized controlled ovarian stimulation (iCOS).~   "
34364|NCT02607280|"~     Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral~     Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal~     impairment.~   "
34365|NCT02607267|"~     The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of~     obesity-related diseases and predictor of mortality than BMI or waist circumference. The aim~     of this study is to determine whether the EOSS is also important in predicting post -~     operative outcome and 30-day mortality after metabolic surgery.~   "
34366|NCT02607254|"~     The purpose of this study is to assess safety and efficacy of treatment with pregabalin in~     patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched~     enrollment randomized withdrawal study that comprises 4 phases: a screening and selection~     phase, a washout period from previous pain medication for enriched enrollment, an 8 week~     single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.~   "
34367|NCT02607241|"~     This prospective randomized clinical trial aims to compare two different metal-free~     strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI~     (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS~     implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).~   "
34368|NCT02607228|"~     This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2)~      The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single~     agent and in combination with enzalutamide, as well as determine the maximum tolerated dose~     (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with~     metastatic castrate-resistant prostate cancer (mCRPC).~      The Dose Expansion phase will evaluate the following:~        -  In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who~          have progressed while receiving enzalutamide (may have also received abiraterone)~        -  In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with~          mCRPC who have progressed while receiving treatment with abiraterone (may not have~          previously received enzalutamide)~        -  In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with~          mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic~          progression, while receiving treatment with enzalutamide (participants may have also~          previously received abiraterone)~   "
34369|NCT02607215|"~     Platinum Retreated in Patients with Platinum Sensitive mTNBC~   "
34370|NCT02607202|"~     Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in~     chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two~     best active single agent - carboplatin or gemcitabine - added to an innovative taxane back~     bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational~     initiative to improve the outlook of patients with cancer of unknown primary through~     evaluation of novel chemotherapeutic regimens.~   "
34371|NCT02607176|"~     The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in~     patients with diarrhea.~   "
34372|NCT02607163|"~     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.~     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and~     postoperative mortality. Aortic surgery is the most risky surgery that causes the~     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.~      The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory~     effects, respectively. Agents that attenuate renal vasoconstriction may have potential as~     renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology~     of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and~     cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its~     potential as a renoprotective agent. Furthermore, it has been already reported that~     dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac~     operation.~      The aim of this study is to examine the association between preoperative dexmedetomidine~     infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing~     aortic surgery.~   "
34373|NCT02607150|"~     A prospective study designed to evaluate changes in tissue and cerebral oxygenation before~     and following administration of blood for patients undergoing spinal surgery.~      Red blood transfusions (autologous and allogeneic) are indicated to improve oxygen delivery~     to the tissues and hence tissue oxygenation. Despite the presumed efficacy, there are~     limited data to demonstrate changes in tissue oxygenation with the administration of blood.~     Furthermore, the administration of both autologous blood from cell saver and allogeneic~     blood can be associated with both acute and long-term deleterious physiologic effects which~     may impact the perioperative course. As such, data are needed to clearly delineate the~     benefits of transfusion during the perioperative period.~   "
34374|NCT02607137|"~     Holistic health is an integration and interaction of physical and psychosocial health.~     Positive psychology is a science of happiness, which focuses on positive emotions and~     personal strengths. It also is crucial component in family holistic health. Healthy diet can~     help to achieve energy balance and healthy weights. Physical activity is believed to~     contribute to physical and mental health, as well as social well-being. However, physical~     inactivity was found to be a local and worldwide issue and most Hong Kong people are having~     a sedentary lifestyle.~      In view of the health challenges locally and globally, the new phase of FAMILY project will~     focus to promote family holistic health with emphasize on the interaction and integration of~     physical and psychosocial health. The investigator will initiate and develop a series~     innovative training program with vigorous evaluation in order to evaluate the effectiveness~     of the programs. The investigator hypothesize that the training programs would promote the~     health awareness and the health of the participants~   "
34375|NCT02607124|"~     In this research study the investigators want to learn more about the effects, both good and~     bad, when the study drug Ribociclib is given after radiation therapy.~      The investigators are asking people to be in this research study that have been newly~     diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and~     have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade~     glioma do not need to have tumor tissue screened for the Rb1 protein but do need to have~     finished radiation therapy.~      Tumor cells grow and divide quickly. In normal cells, there are proteins called~     cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also~     controls cell division and works to stop cells from dividing so they do not become cancer~     cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide~     and grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4~     and 6 proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For~     patients with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The~     researchers think that if the study drug is given soon after radiation therapy, it may help~     improve the effect of the radiation in stopping the tumor from growing.~      The study drug, Ribociclib is considered investigational as it has not yet been approved by~     the United States Food and Drug Administration. The study drug has been tested in children~     and adults with cancer in prior research studies.~   "
34376|NCT02607111|"~     This study evaluates the optimal dosage and safety of Dalteparin when used as an~     anticoagulant for hemodialysis therapies.~   "
34377|NCT02607098|"~     The purpose of this study is to understand the experience of men and their partners when~     diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills~     they use to adapt to this diagnosis.~   "
34378|NCT02607085|"~     This study evaluates the management of subjects with Standard of Care (SOC) when admitted to~     the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics~     and medical history data, including previous ED visits and/or hospital admissions for~     hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an~     intervention/treatment for hyperkalemia will have study-related potassium values determined~     at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no~     intervention/treatment during the initial 4-hour period will have a study-related potassium~     value determined 4 hours after the baseline potassium measurement. Available data obtained~     as part of SOC management will include physical examinations, vital signs, fluid intake and~     urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding~     the subject's chief complaint upon admission to the ED, the possible cause of the subject's~     hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall~     discharge summary will also be collected.~   "
34404|NCT02606708|"~     The primary purpose of this study is to determine the feasibility and tolerability of a~     regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to~     the whole breast as part of breast preservation. In addition, the investigators want to~     prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential~     carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository~     for future studies of other relevant polymorphisms. The study investigators also want to~     prospectively follow each treated woman yearly to assess long-term radiation sequelae of the~     current regimen by using the LENT/SOMA scores.~   "
34405|NCT02606695|"~     A comprehensive approach to the evaluation of alignment in spinal surgery patients - through~     preoperative planning, intraoperative assessment, and postoperative confirmation - has not~     been well-studied. This study aims to assess the value of such planning through clinical and~     radiographic outcomes.~   "
34379|NCT02607072|"~     Background: Evidence of high quality has suggested that acetylsalicylic acid (ASA)/aspirin~     effectively reduces colorectal adenoma incidence and recurrence rate, and several randomized~     controlled trials (RCTs) strongly indicate its potential to prevent colorectal cancer (CRC)~     initiation and progression and to decrease cancer-related mortality. However the role of~     aspirin supplied as an adjuvant agent in postsurgical CRC patients remains obscure, and a~     RCT is warranted for clarification.~      Aim: The APREMEC trial aims to investigate the potential preventative role of enteric-coated~     aspirin (100 mg and 200 mg daily) against postsurgical recurrence and metastasis among Asian~     CRC patients.~      Design: The investigators hypothesize that this large-scale multicenter randomized~     double-blind placebo-controlled trial will support that aspirin can reduce recurrence and~     metastasis and improve survival in postsurgical non-metastasized CRC patients. The primary~     endpoint of this trial is disease-free survival, and the secondary endpoints are 3-year and~     5-year overall survival, the interactive effects of lifestyle including smoking and alcohol~     ingestion, and adverse event rate. Eligible postoperative patients with non-metastasized CRC~     will be randomized in this trial to 100 mg aspirin, 200 mg aspirin or placebo until~     recurrence/metastasis, severe adverse event, death, or end of study, after standard adjuvant~     therapy. Individuals with peptic ulcer, bleeding tendency, or previous or ongoing treatment~     with aspirin or other anticoagulants will be excluded from this trial. Stratification~     factors are gender, study center, cancer site, and tumor stage. After randomization,~     patients will be followed up with evaluations at a 3-month interval while taking study drug.~      Discussion: This study aims at investigation of aspirin's role as an adjuvant agent in~     prevention of postsurgical CRC recurrence and metastasis. If results turn out to be~     positive, Asian and global CRC patients will be greatly benefited, due to the fact that~     aspirin is inexpensive, easily-accessible, and simply-administered, with well know and~     managed adverse events.~   "
34380|NCT02607059|"~     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo~     or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a~     non-interventional research regarding diagnosis and therapeutic approach~   "
34381|NCT02607046|"~     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and~     decreased blood flow to the legs. This may cause difficulty or pain with walking or other~     activities that use leg muscles. Exercise may help improve blood flow in the legs and~     improve the ability to walk. This research project will be conducted patients with PAD that~     require revascularization. The goal is to examine the effects of 3 months of exercise~     rehabilitation and neuromuscular stimulation on leg blood flow, physical function, quality~     of life and general health.~   "
34382|NCT02607033|"~     This study is designed to examine the added benefits of weight loss to an exercise program~     in older obese Veterans with peripheral arterial disease. The investigators want to~     determine if weight loss in addition to exercise will 1) improve walking ability to a~     greater extent than exercise alone and 2) determine the underlying reasons why walking~     ability improves by measuring blood flow and the amount of muscle in the leg muscles.~   "
34383|NCT02607020|"~     Fatigue is the most chronic and disabling symptom in multiple sclerosis patients.~     Self-management physical exercise programs seem promising to allow patients to improve their~     fatigue and their deconditioning. However, the effectiveness of such programs has been~     poorly assessed until now. The objectives of the present study are to evaluate the~     relationships between fatigue and physical capacity among slightly affected MS patients, and~     to carry on a large trial to assess the effectiveness of a self-management exercise program~     in the same patients. Sixty-four patients will be included and will be asked, after an~     educational period, to perform at least three exercise sessions of more than 30 minutes each~     week, over a period of three months. Patients will be splitted in two groups : one group~     will perform endurance and resistance physical exercises, and the other one will perform~     relaxation exercises with the help of soothing music. A regular coaching will adapt the~     exercises and motivate the patients to continue the treatment. Assessors won't be informed~     of patients' treatment. Four evaluations will be done, and will notably assess muscle~     strength, endurance, fatigue and social participation.~   "
34384|NCT02607007|"~     This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt,~     cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose.~     Each participant will receive every treatment in this crossover design study.~   "
34385|NCT02606994|"~     The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated~     healing of chemotherapy-induced oral mucositis.~   "
34386|NCT02606981|"~     Municipal water networks within industrialized countries typically rely on centralized~     treatment to manage piped water quality. Optimal water quality at the tap, however, requires~     well-maintained piped distribution networks, and performs best when piped systems are fully~     pressurized. In low-income cities such as Dhaka, water distribution networks are~     inadequately maintained and typically supply intermittent service; as such, they are~     vulnerable to recontamination during negative pressure events. Among populations accessing~     these types of improved water sources in urban settings (e.g. shared taps), it is unknown if~     consistent treatment to provide chlorinated water at the point of collection would have a~     significant health benefit. Furthermore, almost all previous studies of water treatment~     interventions in low-income countries have been unblinded with self-reported diarrhea as the~     main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not~     due entirely to social desirability bias. Stanford University in collaboration with icddr,b~     will conduct a randomized evaluation to assess the impact on access to automatically~     chlorinated water on water quality and child health.~   "
34387|NCT02606955|"~     Clinical methods are fundamental in probing the DW. They must be supported by strict BIA~     protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in~     HD patients~   "
34388|NCT02606942|"~     Comparing the physical and sonographic findings of dancers with Chondromalacia patella to~     non-dancers athletes.~   "
34389|NCT02606916|"~     This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of~     Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic~     esophageal squamous cell carcinoma patients.~   "
34390|NCT02606903|"~     To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501~     administered subcutaneously via prefilled syringe or autoinjector~   "
34406|NCT02606682|"~     The purpose of this study is to determine the safety, tolerability and blood levels of~     orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose~     will be determined.~   "
34452|NCT02606071|"~     The IRON-MPP is a prospective multicenter, observational registry designed to collect~     clinical and device data from a large cohort of HF patients treated in clinical practice~     with a CRT-D device with the ability to deliver Multi Point Pacing.~      The purpose of the Registry is to collect data on how MPP-devices are being used by~     physicians in order to better understand how to improve the clinical care of patients and~     effectiveness of MPP therapy.~   "
34391|NCT02606890|"~     The aim of this retrospective cohort study is to investigate the relationship between lesion~     pattern on Magnetic Resonance Imaging (MRI) and atrial fibrillation in patients with acute~     ischemic stroke. The investigators hypothesize that a pattern with lesions located in at~     least two of the main arterial territories of the brain (left or right internal carotid~     artery or posterior circulation territory) is associated with atrial fibrillation.~      The investigators will retrospectively analyze clinical data and imaging lesion pattern of~     1000 consecutive patients who were admitted to the Department of Neurology (Charite -~     Universitätsmedizin Berlin, Campus Benjamin Franklin) and diagnosed with acute ischemic~     stroke.~      Acute stroke patients of this cohort underwent 3-Tesla MRI with Diffusion-weighted Imaging~     (DWI) and Fluid-attenuated Inversion Recovery (FLAIR) sequences as well as standard 12-lead~     electrocardiography (ECG) on admission and cardiac monitoring with automated arrhythmia~     detection during stroke unit care lasting at least 24 hours.~      If DWI and FLAIR lesions are located in more than one of the main arterial territories,~     lesion pattern will be categorized as multiple lesion pattern.~      The investigators hypothesize that a multiple lesion pattern will be detected more~     frequently in acute stroke patients with atrial fibrillation than in patients without atrial~     fibrillation.~      The findings of this study might help to identify patients who could profit from extended~     diagnostic work-up in order to detect atrial fibrillation.~   "
34392|NCT02606877|"~     The primary objective of this study is to investigate the effect of steady state pirfenidone~     on the pharmacokinetics of nintedanib and its metabolites following oral administration of~     2403 mg/day pirfenidone and to investigate the effect of steady state nintedanib on the~     pharmacokinetics of pirfenidone at steady state following oral administration of 150 mg bid~     nintedanib. There will be two cohorts of patients; the first one will consist of patients~     not treated with pirfenidone or nintedanib, while the second one will consist of patients on~     pirfenidone treatment.~   "
34393|NCT02606864|"~     This study will evaluate the effect of food on the absorption of the drug as well as safety~     and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering~     from chronic Chagas' disease when administered after a high-fat / high-calorie test meal~     (American breakfast) compared to a fasting state. This study is required as part of the~     clinical development of an age appropriate pediatric oral dosage form for the treatment of~     Chagas' disease in endemic countries according to the recommendations provided by current~     international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA~     Note for Guidance on Oral Dosage Forms).~   "
34394|NCT02606851|"~     China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with~     Gastroesophageal Reflux Disease~   "
34395|NCT02606825|"~     This is a retrospective study to analyze the therapeutic results and clinical evolution all~     patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive,~     treated according to the different schemes available, including supportive care or~     palliative.~   "
34396|NCT02606812|"~     The objective of the Project is to assess the effect of traditional food on the expression~     of micro-ribonucleic acid (miRNA), which regulate genes related to glucose metabolism. It~     will be a randomized experimental research. The research hypothesis is that consumption of~     traditional food will resolve biomarkers of glucose-related anomalies. Students of The~     Academic Division of Health Sciences (DACS for its initials in Spanish) will be invited to~     participate and they will be divided randomly in two groups. The experimental group will~     receive daily, five days per week, during three months, a lunch based on traditional~     Mesoamerican food emphasizing local produce. The experimental group will be provided an~     equivalent ratio of fast food from the school cafeterias. In both groups, at the start and~     end of the protocol, values of lipid, glucose, reactive protein C, alanine aminotransferase,~     and glycosylated hemoglobin profiles will be determined through spectrophotometric methods.~     The levels of expression of five miARN involved in regulating genes related to glucose~     metabolism (miR-320, miR-33a/b, miR-145, miR-335, and miR-124a) will be determined also by~     means of PCR amplification techniques. Statistical analyses will be based on two-way ANOVA,~     with a Dunnet's test procedure to find significance in measurements; significance will be~     set at p ≤ 0.05.~   "
34397|NCT02606799|"~     This study evaluates the effect of extracorporeal removal of inflammatory mediators on the~     systemic inflammation reaction of patients admitted to the intensive care unit following~     elective esophagectomy. Half of the participants will be treated with an adsorption device~     (CytoSorbents Adsorber), while the other half will be treated according to standard care.~     Significant reductions of interleukin-6 plasma concentration, SOFA score and catecholamine~     dosage in the intervention group are expected.~   "
34398|NCT02606786|"~     The purpose of this study is to examine the effectiveness of lumbopelvic stabilization~     exercises on women who have undergone Caesarian sections on: 1) disability using the~     Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain~     Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using~     ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).~   "
34399|NCT02606773|"~     The aim of this study is to evaluate the bioavailability of Novo C Plus vitamin C~     containing dietary supplement compared to licensed vitamin C medications. The novelty of~     this product is the liposomal formulation.~   "
34400|NCT02606760|"~     The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in~     patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and~     concomitant mild to moderate plaque psoriasis.~   "
34401|NCT02606747|"~     This study will evaluate the balance ability of DPN (diabetic peripheral~     neuropathy)patients, which will help us to understand the relationship between peripheral~     and central nervous system, in order to early diagnosis and prevent the fall in DPN~     patients.~   "
34402|NCT02606734|"~     The purpose of this study is to evaluate the usability characteristics of DyeVert™ during~     normal clinical use and to understand the amount of contrast media (CM) diverted from the~     subject and saved over a total angiographic procedure.~   "
34403|NCT02606721|"~     The objective of this study is to correlate various diagnostic measurements taken during an~     escalating dose oral food challenge to the subject's response. This study will investigate~     whether non invasive objective biomarkers can indicate a positive response to an escalating~     dose OFC before a systemic reaction occurs.~   "
34407|NCT02606669|"~     Background and Aims: The 5:2 diet, a form of intermittent energy restriction, has been~     popularized in Europe and USA. The rationale behind this approach is that two days of~     dieting is potentially more achievable, yet long enough to reduce overall weekly energy~     intake. However, this specific approach is lacking in evidence. Therefore, we are keen to~     investigate the effectiveness of this form of intermittent energy restriction compared with~     a control intervention (providing dietary and exercise advice only), in overweight, Chinese~     subjects, for an intervention period of 12 weeks.~      Design and Methods: This will be a randomized controlled trial, with 15 subjects in each~     arm, for an intervention period of 12 weeks. Subjects randomized to the treatment group will~     take three packets of a meal replacement product (Optifast®) per day during two consecutive~     fasting days, and take a healthy balanced diet that meet estimated energy requirements for~     the remaining five days. Subjects randomized to the control group will be given general diet~     advice and allowed to eat ad libitum throughout the study period. Measurements and~     laboratory tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary~     interventions will be assessed at 4 weeks and 12 weeks using 7-day food diaries.~      Significance: This will be the first study looking at an Asian population and will serve as~     a pilot towards a larger randomized trial. If this approach is found to be safe, effective~     and easier to adhere compared to the traditional continuous energy restriction, then it will~     be a very valuable option in the treatment of obesity, which has become an increasing~     problem globally including Singapore.~   "
34408|NCT02606643|"~     Once admitted, women who will have a transcervical balloon catheter inserted for induction~     will be approached for participation in this study. If they agree to be take part in this~     study (tape or no tape) they will be randomized into the study. After the balloon catheter~     is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline,~     this is normal procedure.~      Study related: If randomized to No Taping the foley will be positioned comfortable and not~     placed to tension. For the Tension arm, tension will be placed on the balloon catheter,~     which will then be taped to the patient's inner thigh. The tension will be assessed and~     retaped as needed approximately every 30 minutes by the research and/or the nursing staff.~   "
34409|NCT02606630|"~     This open-label positron emission tomography (PET) study is designed to determine the effect~     of ABT-555 on translocator protein expression level in participants with relapsing forms of~     multiple sclerosis.~   "
34410|NCT02606617|"~     With the improvement of living level, the incidence rates of diabetes, obesity, and~     hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively,~     according to the newly investigated data. The clustering of diabetes, obesity, hypertension~     and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon~     like peptide-1) is a kind of incretin discovered in recent years. It was reported that~     beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could~     decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the~     level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level~     and insulin resistance, which may be related with the change of gastrointestinal hormones~     such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal~     hormone secretion may be a new therapy for glycolipids disorder and vascular complications.~     But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug~     and glycolipids metabolism. So, the investigators designed a prospective, randomized,~     double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug~     (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.~   "
34411|NCT02606604|"~     This study will seek to determine the benefits that FES-LE cycling has over cycling alone on~     walking performance and quality of life in people with multiple sclerosis.~   "
34412|NCT02606591|"~     The goal of this research study is to learn about how brain activity, cognitive tests (tests~     of participant's brain function), and stress hormones are related to taking part in a health~     and wellness program in elementary-aged students.~   "
34413|NCT02606578|"~     Patients that are either scheduled to undergo or have undergone an achalasia procedure at~     the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather~     information and determine if one of these procedures is superior to the other.~   "
34414|NCT02606565|"~     Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income~     countries. Infections, including those affecting the umbilical cord (omphalitis) are a~     significant factor in approximately a third of these deaths. In fact, the odds of all-cause~     mortality are 46% higher among infants with umbilical cord infection than those without~     infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have~     examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX)~     on the umbilical cord on omphalitis and neonatal death. These studies show a consitent~     positive effect of multiple applications on omphalitis but not on neonatal mortality.~     Whereas there is mounting evidence for the effect of 7 day chlorhexidine application, there~     is no data from Africa and only one study from Asia that examines the effect of a single~     application of CHX as soon as possible after birth. In this single Asian study, CHX led to a~     reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an~     African setting to explore the effect of a single application, which is programmatically~     much simpler to implement than daily application for 7 days. Therefore, the investigators'~     study will compare umbilical cord cleansing with a single application of 4% chlorhexidine at~     birth with dry cord care in both community and facility births on omphalitis and severe~     illness in the neonatal period.~      Methods: The chlorhexidine study is a community based, individually randomised controlled~     trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe~     illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness~     associated with at least one of the following danger signs observed by study research~     assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or~     unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in~     death.~      Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of~     the effect of umbilical cord cleansing with a single application of 4% chlorhexidine at~     birth in both community and facility births.~   "
34415|NCT02606552|"~     Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using~     percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus~     aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT~     (dual-antiplatelet therapy)) in patient with coronary artery disease treated with~     drug-eluting stent, accompanying atrial fibrillation.~      Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570~     anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus~     clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary~     endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic~     embolism, and GUSTO bleeding (moderate to severe).~   "
34416|NCT02606539|"~     Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially~     methotrexate and the investigators try to find a role of surgery plus methotrexate instead~     of multiple doses and cycles of chemotherapy.~   "
34417|NCT02606526|"~     BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood~     morbidity and mortality that are separate the vaccine's effect on the incidence of~     disseminated tuberculosis. Though the available literature is mostly from observational~     study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk~     population of HIV exposed children, may protect infants against serious infections other~     than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune~     system is more mature, may offer even greater protection. The appropriate timing of BCG~     vaccination could therefore be up for revision. This study will therefore compare BCG~     vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.~      Methods: This is an individually randomized clinical trial in 2,200 HIV exposed infants. The~     intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of~     birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine~     at 14 weeks of age.~      The main study outcomes include:~        1. Severe illness in the first 14 weeks of life,~        2. TNF, IL‑1b, IL-6 and IFN-γ in response to mycobacterial and non-mycobacterial antigens~          and~        3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.~      The study will be carried in two health Center IIIs and a health center IV in Uganda.~      Implications: A well-timed BCG vaccination could have important additional benefits in HE~     infants. This trial could inform the development of programmatically appropriate timing of~     BCG vaccination for HE infants.~   "
34418|NCT02606513|"~     Tumors of the UUT are rare and usually presenting as micro- or macrohematuria either~     symptomatic or asymptomatic. Rapid advances in CT technology accelerated the research into~     the application of this new technology in the evaluation of the UUT and readily proved to be~     superior to other imaging modalities. Nevertheless the increase in radiation dose is a major~     issue of concern. Initial research into the utility of MRI in the evaluation of the UUT was~     promising, yet the success of CT together with the cost, limited availability and the longer~     duration of MR urography (MRU) examination, nearly halted the investigations into the~     feasibility of MRU which is unfortunate as MRU is a safe alternative to CT.~   "
34419|NCT02606500|"~     The aim of the present study is to determine, whether clinical efficacy of 150 mcg of~     Corifollitropin alfa is the same in normal weighing and obese women. Furthermore,~     investigators want to determine whether oocytes retrieved from normal weighing and obese~     women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular~     level.~   "
34420|NCT02606487|"~     The investigators aim to assess whether pulmonary MRI (hyperpolarised 129Xe ventilation~     imaging [Xe-MRI]) can detect changes in ventilation defects in patients with CF before and~     after treatment for a pulmonary exacerbation. The investigators will determine whether~     changes seen using pulmonary Xe-MRI are associated with changes in pulmonary function~     (spirometry, lung volumes, lung clearance index [LCI]) in patients with CF before and after~     pulmonary exacerbation.~   "
34421|NCT02606474|"~     Cases of previous cesarean with placenta previa anterior underwent cesarean section.~     Placenta accreta is diagnosed during cesarean section &confirmed by pathology. All~     complications are monitored in cases with placenta accreta and without.~   "
34422|NCT02606461|"~     This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of~     patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately~     245 total patients will be randomized to study treatment (selinexor or placebo).~   "
34423|NCT02606448|"~     This is a randomized, single blinded, standard of care controlled clinical trial. All adult~     patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible.~     The study compares pain control and opioid consumption in patients undergoing ACL~     reconstruction between patients receiving liposomal bupivacaine and those who underwent a~     preoperative femoral nerve block.~   "
34424|NCT02606435|"~     This is a prospective, randomized study with blinded outcome assessment, comparing routine~     manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation~     myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).~   "
34425|NCT02606422|"~     Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and~     foremost language abilities. Mild cognitive impairment (MCI) is slowly progressive decline~     in a single domain of cognition (e.g. language) not attributable to motor or sensory loss,~     without impediment of social or occupational function. MCI can be an early sign of~     neurodegenerative disease, or can be due to normal aging. When language is the prominent~     affected domain in MCI, the person may later meet criteria for PPA or may progress to the~     clinical syndrome of Alzheimer's dementia. Spelling, naming, and working memory (e.g.~     repetition) are among the language abilities affected early in the course of PPA or~     language-centered MCI, and different variants have distinct deficits in these domains. This~     research project investigates the behavioral and neuromodulatory effects of transcranial~     direct current stimulation (tDCS) during language therapy in PPA participants over time.~     Anodal tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with~     language therapy is expected to be more beneficial when compared to language therapy alone.~     It will 1) improve language performance or decrease rate of decline, 2) have~     better-sustained effects at 2 weeks and 2 months post-treatment, and 3) produce~     generalization to untrained language items and some other cognitive functions. Resting-state~     fMRI, diffusion tensor imaging (DTI), and volumetric data are also collected to investigate~     changes in functional brain connectivity associated with tDCS in individuals with PPA. A~     better understanding of the therapeutic and neuromodulatory mechanisms of tDCS as an adjunct~     to language therapy in PPA may have a significant impact on the development of effective~     therapies for PPA and MCI, and may offer insight into ways of impeding neurodegeneration~     that may improve patients' quality of life, as well as extend their ability to work and~     manage their affairs.~   "
34426|NCT02606409|"~     Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor~     for benzodiazepines and propofol, has been approved by the US Food and Drug Administration~     only for use up to 24 h in mechanically ventilated patients. The investigators aim to~     compare dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically~     ventilated patients.~   "
34436|NCT02606279|"~     This study is designed to evaluate specific factors in mitochondria that may precipitate~     premature aging and physical weakness in HIV patients. Angiotensin receptors 1 and 2 (AT1R~     and AT2R) are found in virtually every cell type. This study will evaluate how the~     relationships among these receptors in immune and skeletal muscle cells change with HIV, and~     how these changes might trigger mitochondrial dysfunction, declines in muscle strength, and~     cellular decline in people living with HIV.~   "
34453|NCT02606058|"~     To establish if placental transfusion, using deferred cord clamping for 60 seconds or more~     while holding the baby at or below the level of the placenta, will improve survival without~     disability compared with standard early cord clamping in preterm babies less than 30 weeks~     of gestation.~   "
34427|NCT02606396|"~     Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the~     United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with~     esophageal cancer present with tumors which are not amenable to surgery and are treated with~     chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer~     is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking~     tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2~     months for swallowing to improve with this treatment.~      Another method of shrinking esophageal tumors and allowing for better swallowing is~     endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of~     an endoscope); cryotherapy is a well established method for treating cancerous and~     pre-cancerous esophageal disease. This is a particularly attractive treatment option, as~     patients with esophageal cancer usually undergo endoscopy on several occasions before~     starting treatment in order to biopsy and evaluate the tumor.~      The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC~     related dysphagia in patients who are getting ready to start chemotherapy and radiation.~      In order to do this the investigators are planning to invite patients who are already~     undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo~     cryotherapy after the diagnostic portion of the endoscopy has been completed. After the~     cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2~     and 4 weeks after cryotherapy.~   "
34428|NCT02606383|"~     This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the~     new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea~     pedis. Sample size is 140 participants (70 per treatment group), male or female, aged~     between 16 and 60 years-old.~      Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to~     Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety~     and tolerability of Dapaconazole cream 2% after multiple administrations.~      Participants will receive either new intervention or active control during 14 consecutive~     days, which will be followed by 2 follow-up visits.~      Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy~     endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will~     be assessed by adverse events occurrence and laboratory exams evaluation.~   "
34429|NCT02606370|"~     Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during~     gait using an unstable shoe (Intervention group) and a conventional stable control shoe~     (Control Group).~      Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population:~     Patients with Low Back Pain.~   "
34430|NCT02606357|"~     Primary Objective:~      -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes~     patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin~     glargine).~      Secondary Objectives:~        -  To evaluate the percentage of patients achieving target of HbA1c ˂7%.~        -  To evaluate the change in fasting plasma glucose (FPG).~        -  To assess the following safety criteria: hypoglycemic events, body weight changes, and~          overall safety.~        -  Describe the titration process: changes in glargine insulin dose at 3 months and 6~          months, changes in the titration doses used (if any), and time to reach control.~   "
34431|NCT02606344|"~     The high rates of HIV infection in women have brought into sharp focus the problem of~     violence against women. There is a growing recognition that women and girls' risk of and~     vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities~     violence against them in particular. The links between intimate partner violence and~     HIV/AIDS are explained by biological as well as sociocultural and economic factors.~   "
34432|NCT02606331|"~     Thirty six patients needs therapeutic extraction of the maxillary first premolars with~     subsequent retraction of the maxillary canines will be divided randomly into two groups :~     piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group,~     piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side~     of the maxillary arch at the first premolar region, and the other side served as the~     control. Canine retraction will be initiated after completion of the leveling and alignment~     phase via closed nickel-titanium coil springs applying 150 g of force per side, soldered~     trans-palatal arch will be used as an anchor unit.~      Pre- and post distalization dental casts will be evaluated to study rate of canine~     distalization, canine rotation and anchorage loss over a follow-up period until a Class I~     canine relationship is achieved. The levels of pain and discomfort will be self-reported~     using a questionnaire with visual analog scales administered at four assessment times during~     the first month after the minimally invasive procedure.~   "
34433|NCT02606318|"~     The purpose of this study was to clarify the effects on health-related QOL of occupational~     therapy involving the adjustment of challenge-skill balance in the activity of elderly~     clients.~   "
34434|NCT02606305|"~     This is a phase 1b study to assess the safety, tolerability, and preliminary anti-tumor~     activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of~     four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,~     IMGN853 administered with pegylated liposomal doxorubicin or IMGN853 administered with~     pembrolizumab.~   "
34435|NCT02606292|"~     Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy~     has been the most common technique providing clear, real time video images of organs'~     surfaces. However, this technique only images the surface and cannot effectively diagnose~     diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been~     developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases.~     This technique can image very deep areas of organs, up to several centimeters; however, it~     suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue~     abnormalities that do not show mechanical properties that differ significantly from those of~     normal tissues.~      The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of~     the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the~     aforementioned need.~   "
34450|NCT02606097|"~     The main purpose of this study is to examine whether regorafenib treatment can help people~     with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The~     safety of regorafenib treatment is also examined.~   "
34437|NCT02606266|"~     Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory~     deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop~     deafness, some of whom will progress gradually to profound bilateral deafness.~      No curative treatment is currently offered for this deterioration in hearing and management~     involves the use of a hearing aid or cochlear implant. Many studies describe the utility of~     antiviral treatment on the course of the deafness. These mostly involve neonates with~     multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir~     possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss,~     or even improvement.~   "
34438|NCT02606253|"~     Broad Objectives: To determine the comparative efficacy of commonly employed strategies to~     overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized~     decompensated heart failure patients with hypervolemia~      Specific Aims:~        1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral~          tolvaptan compared to standard-of-care oral metolazone when combined with standardized~          loop diuretic dosing for diuretic resistance in decompensated heart failure~        2. Compare the adverse effects of electrolyte depletion and renal function changes between~          intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral~          metolazone when combined with standardized loop diuretic dosing for diuretic resistance~          in acute heart failure~        3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral~          tolvaptan compared to standard-of-care oral metolazone when combined with standardized~          loop diuretic dosing for diuretic resistance in acute heart failure~      The investigators will conduct a dual center, randomized, double-blind, double-dummy,~     parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral~     tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic~     decompensated heart failure and displaying loop diuretic resistance.~   "
34439|NCT02606240|"~     This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and~     device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following~     tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.~   "
34440|NCT02606227|"~     Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth~     outcomes and may have long-lasting effects in the offspring.Financial incentives may~     increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative~     health effects. This is a randomized open label study comparing financial incentives for~     smoking abstinence with no financial incentives for smoking abstinence.Research objectives~        1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant~          smokers;~        2. To explore the heterogeneity of efficacy according to individual characteristics:~          socioeconomic status, social background, smoking characteristics, personality traits,~          time and risk preferences to determine profiles of women which could benefit best from~          this kind of intervention;~        3. To provide a cost-benefit analysis based on the cost of newborn and children disease~          due to maternal smoking during pregnancy.~   "
34441|NCT02606214|"~     The objective of the study is to evaluate the safety and tolerability of multiple doses of~     TBA-354 in healthy subjects.~   "
34442|NCT02606201|"~     Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form~     of incontinence that may have a major impact on the quality of life. The main treatment is~     surgical and consists in the implantation of medical devices such as the artificial urinary~     sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent.~      The investigator has developed a new therapeutic strategy for ISD that consist to implant~     myofibers with their attached satellite cells (the main source of muscle progenitor cells)~     at the vicinity of the striated urethral sphincter. The principle of this method relies on~     the in vivo activation of satellite cells leading to the formation of regenerated myofibers~     (myotubes) generating a distinct and tonic muscular activity . The proof of concept was~     investigated in a Phase I clinical trial: Investigator found that the periurethral~     implantation of myofiber strips around the urethra generated an electromyographic activity~     improving urethral closure pressure in women with severe urinary incontinence associated to~     ISD. In this previous study, the technique of myofiber implantation was invasive, as it~     required a surgical approach and dissection of the urethra to place the myofiber. For the~     clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation~     process using a method injection of myofibers core obtained by hydro-dissection. The~     injection technique is performed percutaneously under fluoroscopic and endoscopic control~     and does not require a surgical approach of the urethra.~      This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center~     for the first stage and multicenter for the second stage, of 13 months for each patient aims~     to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women~     with ISD.~   "
34443|NCT02606188|"~     The purpose of this study is to determine whether the Modified High-flow nasal cannula is~     effective in the oxygen of the patients undergoing bronchoscopy.~   "
34444|NCT02606175|"~     Patients who receive a kidney transplant have to learn in 10-14 days which anti-rejection~     medication to take, how to take it ,... This learning process is attended by the nurses of~     the ward. This study wants to measure the degree of medication knowledge, health literacy~     and medication adherence of those patients.~   "
34445|NCT02606162|"~     The purpose of this study is to determine the outcomes of severe osteoporotic fractures~     hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the~     risk of mortality over 2 and 5 years.~   "
34446|NCT02606149|"~     Patients with metastatic cancer have a substantial symptom burden and may receive aggressive~     care at the end of life. There is evidence that the use of chemotherapy near the end of life~     is not related to its likelihood of providing benefit and the overuse of aggressive~     anticancer therapies near the end of life may result in more toxicity than clinical benefit.~     Moreover, proposing new lines of treatment after successive therapeutic failures may be a~     way of avoiding discussion of prognosis and advance care planning. It has been proposed that~     systems not providing overly aggressive care near the end of life would be the ones in which~     less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the~     first consultation between patient and oncologist is ruled in France by the first Plan~     Cancer and the Dispositif d'annonce (announcement planning). Oncologists are supposed to~     explain the diagnosis of cancer and to present a treatment plan. In routine practice for~     metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and~     its side effects are explained. The use of chemotherapy has been associated with the~     worsening of two major competitive life-threatening conditions for cancer patients: cachexia~     and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is~     hardly explained in routine practice.~      This study proposes to examine in a monocentric interventional prospective randomized trial,~     the impact of a particular way for the oncologist to present chemotherapy at the diagnosis~     stage on the easiness of timely chemotherapy interruption at the end of life. The main~     objective is to determine whether or not the explanation of the potential role of anticancer~     chemotherapy in worsening life-threatening conditions impacts the proportion of patients~     receiving chemotherapy in the last 30 days of life compared with usual presentation.~     Secondary objectives are to determine the impact of this communication strategy on overall~     survival and other indicators of aggressiveness of care and palliative care resources use.~      The hypothesis is that the intervention will allow 15% of patients receiving anticancer~     therapy during the last 30 days of life, as compared to 30% in the control group.~      The investigators expect that the intervention evaluated in this study will reduce the rate~     of patients receiving chemotherapy during the last 30 days of life hopefully improving the~     quality of end of life care. A secondary objective is overall survival and this study will~     therefore verify that the intervention arm is not associated with poorer overall survival.~     But more probably investigators expect patients in the intervention arm to have an improved~     overall survival mainly link to a decrease in harms due to chemotherapy given near the end~     of life and to better palliative care. In effect the hypothesis is that showing the~     life-threatening risks associated with chemotherapy and thus reducing for patients the~     importance of this treatment will leave room for improved palliative care as shown notably~     by earlier and more frequent referral to palliative care specialists. If this trial is~     positive, it will prove the capital role of patient-doctor communication in cancer care and~     that few differences in communication strategy could improve end of life care and maybe even~     survival. The impact on the oncology community would be major since the intervention could~     be easily transposed in all practices at no additional cost. It would also emphasize the~     importance of communication skills and human relationship in the very technical field of~     medical oncology.~   "
34447|NCT02606136|"~     This is a Phase 2, open-label, single arm trial of FG-3019 to estimate FG-3019 efficacy in~     non-ambulatory subjects with DMD.~   "
34448|NCT02606123|"~     The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In~     Part I, patients will participate in single, multiple, and long-term dosing periods using~     EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary~     indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design,~     dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning~     at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after~     their initial twelve weeks.~      In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate~     cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and~     post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose~     (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in~     each cohort) will be enrolled.~   "
34449|NCT02606110|"~     The purpose of this study is to investigate the effect of the ReBuilder in the treatment of~     individuals with breast cancer and chemotherapy induced peripheral neuropathy.~   "
34454|NCT02606045|"~     This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing~     recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize~     menorrhagia in women with type 1 von Willebrand disease (VWD). The purpose of this Phase III~     multicenter prospective, randomized, crossover arm trial is to compare recombinant von~     Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in~     women with von Willebrand disease.~   "
34455|NCT02606032|"~     The investigators will test the hypothesis that giving antibiotics prior to fecal transplant~     therapy for active UC increases the proportion of patients in remission at the end of~     treatment. The investigators will randomize patients aged 18 or over with active UC to~     antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for~     two weeks); or identical placebo. At the end of two weeks the investigators will give all~     patients fecal transplant therapy twice per week for eight weeks from the donor whose stool~     showed most efficacy in the trial (donor B). Patients will complete a validated UC~     questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the~     colon and complete general and disease specific quality of life questionnaire as well as a~     questionnaire on anxiety and depression. Patients will complete the same questionnaires~     again at the end of treatment at week 9 when they will also have a repeat flexible~     sigmoidoscopy. The main outcome that will be assessed is the proportion of patients in~     remission from their UC at the end of treatment.~   "
34456|NCT02606019|"~     The burden of dengue infection has increased due to the current non-specific classification.~     A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular~     endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1)~     and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in~     differentiating severe dengue from non-severe dengue cases. The analysis between severe~     dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two~     categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at~     the margin of the pre-determined p-value of less than 0.05.~      Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue~     from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF~     and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit)~     and liver function test (alanine aminotransferase and aspartate).~   "
34457|NCT02606006|"~     Thousands of canines are used for therapy in health care centers throughout the United~     States as part of a volunteer therapy team, yet little is known about the outcomes provided~     by these teams. Although many studies have been published, few used randomized, controlled~     formats to identify whether canine therapy has an impact and any mechanisms by which any~     impact may occur. The purpose of this study is use a randomized, controlled setup for canine~     animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke,~     Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT~     produces desirable outcomes, such as increased motivation, in patients.~   "
34458|NCT02605993|"~     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of~     multiple IV doses of ALXN1210 administered to complement inhibitor treatment-naïve patients~     with PNH.~   "
34459|NCT02605980|"~     United Kingdom (UK) physical activity guidelines for older people state that All older~     adults should minimise the amount of time spent being sedentary (sitting) for extended~     periods and there is sufficient evidence to support a recommendation to reduce sedentary~     behaviour in older adults, but it is not currently possible to suggest a specific time~     limit. The aim of this study is to identify key physiological and psychological outcomes~     influenced by acute periods of inactivity and what older people feel after these acute~     periods of inactivity. The investigators' main objective is to determine, through direct~     measurement and self report, the acute functional and cognitive effects of differing periods~     of sitting time. A secondary objective is to inform older people, professionals and~     organisations working with older people and policy makers on what duration of sedentary~     behaviour will lead to adverse outcomes in older people. The investigators will recruit~     ambulatory men and women aged 70 y and over who will be studied on three separate occasions,~     approximately one week apart to complete sedentary bouts of 1 h, 2 h and 4 h in a randomised~     crossover design. The investigators will explore the relationship between sitting time and~     changes in lower limb explosive power(primary outcome) measured before and after each bout.~     Secondary outcomes will include timed chair rise; Timed Up and Go; blood pressure;~     perception of musculoskeletal comfort/pain, vitality; mood and cognitive function. The~     investigators will also measure the stress hormone cortisol in samples of saliva taken at~     the start of the sitting session, 1 h, 2h and 4 h later. Characterising the acute effects of~     sitting time in older adults will enable the design of interventions to reduce sedentary~     time as well as inform professionals and policy makers on what duration of sedentary~     behaviour will lead to adverse outcomes.~   "
34460|NCT02605967|"~     The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001~     versus investigator's choice of chemotherapy in patients with advanced NPC.~      By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to~     the activation of a T cell mediated antitumor immune response~   "
34461|NCT02605954|"~     This study will evaluate the efficacy of switching to~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) relative to continuing on a baseline regimen consisting of~     abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in maintaining HIV-1 virologic~     suppression.~   "
34462|NCT02605941|"~     The purpose of this prospective study is to evaluate whether DNA methylation can be applied~     in cervical cancer screening.~   "
34463|NCT02605928|"~     The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections~     inside joint capsules specifically. The main purpose of the study is to assess and validate~     the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the~     benefits, drawbacks and risks related to use of the BIP Needles.~   "
34464|NCT02605915|"~     This is a Phase Ib, open-label, two-stage study with two active regimens in each stage~     designed to evaluate the safety and tolerability of combination treatment with atezolizumab,~     trastuzumab, and pertuzumab or atezolizumab and trastuzumab emtansine in human epidermal~     growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced~     early breast cancer (EBC).~   "
34505|NCT02605382|"~     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a~     chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment~     protocol with a six-month follow-up.~   "
34545|NCT02604836|"~     This study will investigate participant satisfaction (including compliance, preference,~     tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or~     osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on~     study treatment is 6 months, and the target sample size is 1776 individuals.~   "
34465|NCT02605902|"~     Gilles da la Tourette syndrome (TS)* is a common chronic neuropsychiatric disorder~     characterized by motor and vocal tics. In most adult patients, quality of life is~     significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total~     costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were~     recommended as first choice treatment for many years. Although efficacy could be~     demonstrated only recently, today, behavioral therapy with face-to-face Comprehensive~     Behavioral Intervention for Tics (CBIT) (including psychoeducation, habit reversal training,~     function-based assessment and intervention, and relaxation training) is recommended as first~     line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a~     considerable lack of well-trained therapists. The aim of this study is to overcome this~     deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In~     addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of~     patients and will be - once developed and established - highly cost-effective (about € 100~     vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized,~     controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8~     sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation~     in adult patients with TS. Both immediate (1 week after end of treatment) and long-term~     effects (after 3 and 6 months) will be evaluated.~   "
34466|NCT02605889|"~     This is a randomized clinical research, with triple blinded multicenter involving the~     Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a~     proponent and research coordinator; and as a collaborative educational institutions, the~     Federal University of Espirito Santo, represented by the Department of Nursing; and the~     Higher School of Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's~     Programme in Public Policy and Local Development.~      As Research, the study covers health units of the Municipal Family Health Maricá / Rio de~     Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project~     Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.~      The object of investigation is the effectiveness of acupuncture in nursing care in~     complementary treatment of adult patients Diabetes Mellitus type II.~   "
34467|NCT02605876|"~     This study will evaluate the acute effects of vibration (whole body vibration and local~     muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics~     linked to osteoarthritis development in individuals with anterior cruciate ligament~     reconstruction. Subjects will be randomly assigned to control (no vibration), whole body~     vibration, and local muscle vibration groups, and the aforementioned characteristics will be~     assessed prior to and following the respective interventions.~   "
34468|NCT02605863|"~     The purpose of this study is to examine the effect of androgen deprivation therapy through~     administration of enzalutamide on preventing bladder cancer recurrences in patients with~     non-muscle invasive bladder cancer (NMIBC).~   "
34469|NCT02605850|"~     This study will determine the effects of beneficial compounds of plant foods, such as~     pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a~     high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water~     and then measuring blood vessel dilation (endothelial function) by blood flow We also will~     measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and~     insulin in blood. Healthy men have been chosen for this study because eating high fat~     hamburger patties can easily mimic in them the condition that causes atherosclerosis. The~     results from this study may help to explain how high fat foods can be harmful to the body~     and how beneficial plant foods can have on cardiovascular function~   "
34470|NCT02605837|"~     A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the~     histologic response and determine if any reduction in dysphagia is achieved.~   "
34471|NCT02605824|"~     This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma~     that is complicated by mucus in the airway, as determined by CT imaging. The study is a~     crossover design, which means that half the study participants will get 20% NAC in the first~     7-day treatment period and placebo in the next 7-day treatment period; and the other half~     will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment~     period.~   "
34472|NCT02605811|"~     To investigate the response of temozolomide versus prophylactic cranial radiotherapy in~     preventing brain metastases in completed or partial remission limited small cell lung cancer~     patients.~   "
34473|NCT02605798|"~     Comparative randomized, single dose, three way three sequence two treatment partial~     replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from~     Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus~     Sovaldi 400 mg Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United~     Kingdom)~   "
34474|NCT02605785|"~     This study is designed to learn more about overall tau burden in the brain of patients with~     Progressive Supranuclear Palsy (PSP).~   "
34475|NCT02605772|"~     To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With~     Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be~     enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or~     Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before~     and after the interventions.~   "
34476|NCT02605759|"~     To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for~     the treatment of esophageal squamous cell dysplasia.~   "
34477|NCT02605746|"~     This is two parallel studies to examine pharmacokinetic (PK), pharmacodynamic (PD), and~     pharmacogenetic (PG) endpoints following short-interval therapy (10-14) daily doses without~     dose reduction and interruption) with the ALK (anaplastic lymphoma kinase) small-molecule~     inhibitor, ceritinib.~      The Phase 0 study will investigate:~        1. first recurrence GBM patients and~        2. patients with CNS metastases from solid tumors such as, but not limited to, NSCLC~          (non-small cell lung cancer) and melanoma.~      The CNS (central nervous system) metastases Phase 0 is designed to identify PK effects (in~     addition to PD, and PG effects on ALK-positive NSCLC metastases), while the GBM Phase 0 is~     designed to identify PK, PD, and PG effects in all patients.~   "
34478|NCT02605733|"~     The purpose of this study is to characterize the normal brain function of premature infants~     (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.~   "
34479|NCT02605720|"~     Mass drug administration with antimalarial treatment is a tool that can potentially reduce~     or totally eliminate malaria parasite infections from a population.~     Dihydroartemisinin-piperaquine (DHA/PPQ) given monthly for 3 months to the entire population~     might be a good candidate for mass drug administration because the long acting PPQ exerts a~     long post-treatment prophylactic effect against reinfection and relapse. The use of a~     repeated dose of DHA/PPQ could lead to increased PPQ plasma concentrations and increased~     cardiotoxicity. However, there is no data on a second course of treatment or on safety of~     the drug administered in repeated monthly doses. The proposed project is a clinical trial to~     assess the electrocardiographic safety of monthly DHA/PPQ (for 3 days at a time) for 3~     months. The investigators aim to assess the safety of the drug to be used monthly in mass~     treatment campaigns. Recommendations issued from this study will benefit health authorities~     on Lihir-Island by setting the stage for a possible subsequent campaign to completely~     eliminate malaria from the whole island. This study could be a crucial step to inform the~     feasibility of drug-based strategies for eliminating malaria elsewhere in PNG, other~     Melanesian countries and throughout the world.~   "
34480|NCT02605707|"~     Stroke is a frequently occurring and common diseases in nervous system,and most of the~     survivors will remain disorders of motor,sensory and cognition function.Stem cell~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy and safy of the transplantation of autologous endothelial~     progenitor cells in patients with chronic stroke.~   "
34481|NCT02605694|"~     Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with~     relapsed/refractory FL~   "
34482|NCT02605681|"~     The purpose of this study is to assess the relationship between midkine level and ACE-Ang II~     induced endothelial injury in sepsis.~   "
34483|NCT02605668|"~     PROTECT-AD is a cognitive behavioral treatment study involving highly qualified~     psychotherapeutic centers at seven German universities.~      It is our goal to further investigate and optimize existing effective treatments of anxiety~     disorders. In order to achieve this, the investigators want to investigate the effect of~     extinction learning in an intensified psychological intervention on treatment outcome in~     adults and children with anxiety disorders.~      The intensified psychological intervention is characterized by a higher number of exposure~     trials over a short time period. In the control condition the exposure trials take place in~     a weekly interval, analog to standard care.~   "
34484|NCT02605655|"~     The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on~     Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other~     half received placebo.~   "
34485|NCT02605642|"~     To assess persistence of Inflectra in patients with Rheumatoid Disease (Rheumatoid arthritis~     [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naive to biologics~     or are switching over from stable Remicade to Inflectra. The main objectives of the study~     are:~        -  To evaluate real-life drug persistence in RA, AS, and PsA patients who are either~          initiated with Inflectra™ as their first biologic, or who are switched from stable~          Remicade™~        -  To characterise the patient populations and drug usage patterns of RA, AS, and PsA~          patients who are either initiated with Inflectra™ as their first biologic, or who are~          switched from stable Remicade™~        -  To assess the safety of Inflectra™ in RA, AS, and PsA patients who are either initiated~          with Inflectra™ as their first biologic, or who are switched from stable Remicade for~          up to 2 years~   "
34486|NCT02605629|"~     This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy~     induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center,~     randomized, controlled trial in breast cancer survivors.~      Hair condition and parameters of 61 breast cancer survivors who were previously included in~     DERMA study (a prospective cohort study to assess appearance changes due to breast cancer~     treatment completed in July, 13th,2013) will be assessed.~        1. Patients whose hair parameters are below the baseline as measured before the start of~          the chemotherapy or~        2. who complain from incomplete hair regrowth will be eligible to participate in the~          randomized controlled trial.~      Patients who agree to participant in the study will be randomly assigned to two parallel~     arms (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or~     placebo twice per day (morning, evening) for 6 months, for the efficacy assessment.~      Primary endpoint was recovery of hair thickness 6 months after intervention as assessed~     using Folliscope 4.0.~      Secondary endpoints included hair density at 6 months after intervention, distress due to~     chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported~     hair quality improvement, body image and quality of life, and time to first visible~     improvement based on global photographs of hair and nails.~   "
34487|NCT02605616|"~     Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo~   "
34488|NCT02605603|"~     This project is expected to elucidate role of different therapeutic interventions: SRT in~     comparison to ERT in influencing immune aspects of GD pathology, as well as bone~     involvement.~   "
34489|NCT02605590|"~     This study will be performed to assess the safety, tolerability and PK of escalating inhaled~     AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive~     days in healthy subjects.~      A thorough review of safety data will be conducted after completion of each dose level per~     subject and prior to both, moving to the next dose level in Part 1 and commencement of the~     multiple dose Part 2.~   "
34490|NCT02605577|"~     The purpose of the project is to investigate the status of nutrition management of late~     preterm infants in the member hospitals in the Beijing association of preterm infants, and~     set up the systemic nutritional management of late preterm infants, Including parenteral~     nutrition and enteral feeding. And to compare the differences of growth and complications of~     these infants between groupings applicationg and not applicating the systemic nutritional~     management of late preterm infants,and to validate its feasibility and validity.~   "
34534|NCT02604979|"~     Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy,~     which is performed in a head up position under CO2 pneumoperitoneum.~      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the~     susceptibility to life threatening cardiac arrhythmias.~      Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc~     interval) during robotic-assisted laparoscopic gastrectomy.~   "
34491|NCT02605564|"~     The central hypothesis of this proposal is that a gluten-free diet introduced shortly after~     diagnosis can reverse or arrest islet destruction in children and adolescents with type 1~     diabetes mellitus (T1DM). The specific aims are to determine the effects of a gluten-free~     diet on 1) endogenous insulin production and 2) the corresponding gut flora of children with~     new-onset type 1 diabetes. This is a randomized placebo controlled clinical trial testing~     the effect of altering the gut microbiome via a gluten-free diet on endogenous insulin~     production as a measure of the pace and severity of islet destruction at the time of~     diagnosis of type 1 diabetes. The project entails eliminating gluten from the diet of the~     intervention group and comparing bacterial gut flora and endogenous insulin response with~     those in a control group up to one year following the diagnosis of type 1 diabetes. The~     proposal introduces a new potential etiology for type 1 diabetes in humans: the Bacterial~     Hypothesis. The short term goal is to identify specific islet-preserving microbiome changes~     induced by eliminating gluten from the diet of patients recently diagnosed with type 1~     diabetes. The long term goal is to develop these changes into effective and safe strategies~     that can allow patients with type 1 diabetes to achieve permanent insulin-independence.~   "
34492|NCT02605551|"~     The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT)~     in the effective management of hypertension. The investigators hypothesize that by~     addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be~     the root cause of the elevation in blood pressure will be downregulated. If this is the~     case, then an effective therapy for hypertension could indeed be regular OMT treatment. This~     could also result in the avoidance of potentially harmful antihypertensive medications which~     comprise a majority of the current therapeutic strategy in the treatment of hypertension~     (along with lifestyle modification). A third implication of the results of this project~     could be a reduction in the progression of this disease. Under the current standard of care,~     a majority of hypertensive patients only experience a worsening of the disease over time~     under the current therapeutic guidelines.~   "
34493|NCT02605538|"~     CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients~     according to European consensus. The aim of the study is to vaccinate as many patients as~     possible and to follow up whether immunization has been complete.~   "
34494|NCT02605525|"~     The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of~     Immunoglobulin A nephropathy (IgAN)~   "
34495|NCT02605512|"~     Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality~     due to long term cardiac complications. Since the 2000s, improvements have appeared in dose~     distributions to organ at risks such as heart, but now, little is known on the risk of~     potential cardiac impairment in this population, in particular for chemotherapy naive~     patients. Based on the state that clinically detectable cardiotoxicity is generally preceded~     by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and~     Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces~     cardiac toxicity that could be detected in the first two years after treatment based on a~     global approach with repeated analysis of subclinical functional and anatomical cardiac~     lesions in myocardial and coronary levels and circulating biomarkers.~   "
34496|NCT02605499|"~     This study examines the impact of UV-C light disinfection as an adjunct to routine daily and~     discharge patient room cleaning on patient infection and colonization with hospital~     associated bacteria.~   "
34497|NCT02605486|"~     The purpose of this study is to test the safety and effectiveness of the investigational~     drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor~     positive breast cancer.~   "
34498|NCT02605473|"~     The goal of the first phase of this clinical research study was to find the highest~     tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to~     patients with melanoma. The first phase was completed but the study did not progress to the~     second phase.~      The goals of the second phase of this clinical research are to learn if decitabine and~     peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are~     more effective and/or better tolerated.~   "
34499|NCT02605460|"~     The purpose of this study is to evaluate the disease free survival and the overall survival~     in patients with acute leukemia in first or second complete remission after administrating a~     CXCR4 antagonist, as a chemo sensitization strategy, plus chemotherapy as the conditioning~     regimen for autologous or allogeneic hematopoietic stem cell transplantation (HSCT).~   "
34500|NCT02605447|"~     The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to~     assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with~     a SYNERGY Stent System.~   "
34501|NCT02605434|"~     The purpose of this study is to determine whether the gastric retentive Accordion Pill™~     Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate~     release Carbidopa/Levodopa in reducing motor fluctuations such as off time in advanced~     Parkinson's Disease patients.~   "
34502|NCT02605421|"~     This is a phase II single center study to administer two courses of myeloablative~     consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC)~     rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy~     (independent of this study). Ideally, patients should begin consolidation chemotherapy no~     later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended~     to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.~   "
34503|NCT02605408|"~     The purpose of this study is to record and analyze the profile and outcome of cataract~     patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL)~     implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian~     tertiary medical centers.~   "
34504|NCT02605395|"~     This is an open-label, randomized, single dose, two-sequence, two-periods crossover study,~     separated by 7 days washout interval from the first Study Drug Administration. This study is~     conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release~     (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each~     to healthy adults fed under conditions.~      In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR~     tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to~     receive the treatment that they did not receive in Period 1.~      PARIET is a registered trademark of EISAI Co. Limited.~   "
34506|NCT02605369|"~     Universal coverage of good quality facility based care globally could prevent nearly 113,000~     maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet,~     only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably~     low coverage of facility based births could explain, in part, the high maternal and~     perinatal mortality estimates in Uganda. While multiple studies have examined factors~     associated with this low utilization of health services around the time of birth, there is~     inadequate implementation research exploring the best systematic methods that could promote~     uptake and scale up of facility based births. This study will therefore examine the effect~     of an intervention package (peer counselling by pregnancy buddies on facility based births,~     mobile phone messaging promoting facility based births and provision of mama-kits) on the~     frequency of facility based births and perinatal mortality. The study, a cluster randomized~     community based intervention trial in post-conflict Northern Uganda, will provide data~     crucial in framing national policy regarding measures to promote the use of health~     facilities.~   "
34507|NCT02605356|"~     This study will be conducted in 2 parts. The phase 1b part will be an international, phase~     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with~     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary~     endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in~     combination with bortezomib/dexamethasone for the Phase 2 portion of the study.~      The phase 2 part will be an international, phase 2, double-blind, randomized,~     placebo-controlled assessment of radium-223 dichloride versus placebo administered with~     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization~     (1:1) in the phase 2 part will be stratified by:~        -  Prior bortezomib treatment (yes, no)~        -  Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately~          30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study~          and approximately 196 subjects will be enrolled in the phase 2 part of the study.~   "
34508|NCT02605343|"~     The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided~     treatment when implemented into the pre-operative process for patients undergoing bowel~     surgery, major urologic procedure, or major ventral hernia repair and requiring~     post-operative acute pain management in an inpatient basis, as compared to a group of~     subjects with the same attributes without the guidance of PGx testing (historical control~     group). This study will also evaluate the frequency with which the standard analgesic care~     plan is adjusted by test results.~   "
34509|NCT02605330|"~     The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and~     thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.~   "
34510|NCT02605317|"~     The aim of this study is to determinate outcomes of WhatsApp Messenger (a messaging program~     for smart phones) usage for Communication Between Consulting Physicians and the Emergency~     Physicians.~   "
34511|NCT02605304|"~     People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of~     the infection when they are treated with sofosbuvir. However, in some instances, treatment~     with sofosbuvir-containing therapy does not work. It is not known if treating people with~     sofosbuvir again (retreatment) after it did not work the first time will work. There is an~     important need to understand retreatment options in those instances. This study is being~     done to see if two different regimens, ledipasvir with sofosbuvir and ribavirin for 12 weeks~     (Group A) and ledipasvir with sofosbuvir for 24 weeks (Group B) are well tolerated in~     HCV-infected persons where previous treatment with sofosbuvir failed. This study will also~     look at the safety of each regimen and how well the combination treatment of~     ledipasvir/sofosbuvir works in people who have cirrhosis (scarring of the liver) or HIV.~   "
34512|NCT02605291|"~     This study will investigate the effect of dietary macronutrient manipulation on glycogen~     (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The~     investigators will investigate the hypothesis that manipulating the macronutrient content of~     the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation~     during exercise.~   "
34513|NCT02605278|"~     This study evaluates whether the implementation of an integrated clinical program for~     chronic musculoskeletal pain and depression behave better clinical outcomes than the usual~     approach in primary care~   "
34514|NCT02605265|"~     The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of~     participants will receive capecitabine alone together with neoadjuvant CRT, followed by a~     cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT,~     followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8~     weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.~   "
34515|NCT02605252|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha-2b and NAs.~   "
34516|NCT02605239|"~     58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental~     School, Universidad de Chile, were included in the study. Those patients were bleaching and~     included in this study and signed a consent form. The patients were treated with 10%~     carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal~     instructions for 3 weeks with daily applications of 1 hour according to manufacturers~     indications , before and after this procedure was applied again the OHIP-Esthetics , PIDAQ~     and OES questionnaire form, had 30 minutes to answer it, were completed before , immediately~     after and one month control post-bleaching procedure.~   "
34517|NCT02605226|"~     This trial is going to evaluate tumor control and quality of life in patients with prostate~     cancer treated with radiotherapy or cryoablation.~   "
34544|NCT02604849|"~     The identification of all cases (44 patients) was carried out from the database of~     microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the~     identification of controls, in case of neutropenic patients, all colonized patients that~     were included during the study period did not receive any decolonitation treatment; in case~     of non-neutropenic patients it was studied a paired control by the presence of risk factors~     that indicated the beginning of decolonitation treatment.~   "
34572|NCT02604485|"~     The purpose of this study is to evaluate the safety and clinical pharmacology of a single~     dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia~     associated with congenital hyperinsulinism.~   "
34518|NCT02605213|"~     Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that~     involves intra and extra hepatic biliary system. There is no curative treatment for this~     disorder. Supportive and conservative treatments are the most common therapies that used for~     this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in~     some situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic~     bacteria such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is~     recommended for treatment of these patients. Therefore according to the great role of~     anaerobic bacteria such as cholestridium difficile in pathogenesis, antibiotics such as~     metronidazole and vancomycin can be counted as recommended therapies in PSC. In addition~     some studies correlated this effect of vancomycin to its immunomudulatory effect the cause~     reduction of inflammation in biliary system. But with all this detail there is no finality~     about effectiveness of antibiotic therapy and accordingly in this study the investigators~     compare oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.~      In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided~     in two 15 persosns group with Block Randomization method. in this study one group receive~     250 mg oral vancomycin every 6 hours and other group receive placebo.~      The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months~     after treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin~     and clinical manifestations such as tiredness, itching and probable adverse effects such as~     hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or~     red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.~   "
34519|NCT02605200|"~     The purpose of this study is to determine the influence of post-transplant diabetes on~     medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to~     18 years of age and their families.~   "
34520|NCT02605187|"~     The ability to predict pain and then apply modified treatment protocols has been limited.~     Current practice is for physicians to select standard post-operative pain treatment~     protocols without patient consultation. This study hopes to determine if patient's~     involvement in analgesic drug/dosage selection can optimize pain relief while minimizing~     related side effects. This could result in a more patient-centered care model and~     individualized perioperative analgesic treatment protocols based on patient's preferences,~     needs and expectations.~   "
34521|NCT02605174|"~     This is a prospective randomized, double-blind, placebo-controlled study in subjects with~     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).~   "
34522|NCT02605161|"~     The purpose of this study is to evaluate the blood brain barrier in the striatum of patients~     that have other types of movement disorders compared to patients with Parkinson's Disease~     that are receiving similar treatment, to determine if a there is a disruption of the blood~     brain barrier in patients with Parkinson's Disease.~   "
34523|NCT02605148|"~     To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose~     metabolism in subjects with one or several islet autoantibodies without and with dysglycemia~     at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty~     acids and probiotics.~      Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will~     be evaluated at baseline, and during follow-up by glucose tolerance tests.~   "
34524|NCT02605135|"~     The ability to determine the postmenopausal vaginal environment and the impact of pessary~     use could help to maximize pessary therapy and non-surgical treatment for such a prevalent~     problem.~   "
34525|NCT02605122|"~     This is a phase 2/3, randomized, open-label, active control, multi-center study to assess~     the safety and efficacy of solithromycin in children and adolescents with community-acquired~     bacterial pneumonia (CABP).~   "
34526|NCT02605109|"~     This study aimed to analysis the characteristics of MERS transmission and the effect of our~     institutional personal protective equipment on the controlling the MERS at a tertiary Korean~     Hospital.~   "
34527|NCT02605096|"~     This pilot study aims to test the feasibility and work flows associated with using MRI as~     the initial imaging modality in the investigation of patients presenting with suspected~     scaphoid fracture.~      This pilot will be used to inform the design of a study that will aim to evaluate whether~     the proposed intervention is likely to generate cost-savings whilst improving or maintaining~     overall patient quality of life and satisfaction.~   "
34528|NCT02605083|"~     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and~     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     antitumor activity of daily oral administration of eFT508.~   "
34529|NCT02605070|"~     Single center, prospective, open clinical study to determine the genomic imprint (epigenetic~     modification) in a series of male infertility patients with alterations in their spermiogram~     (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of~     FSH ( follicle stimulating hormone) administration on these modifications and on male~     infertility.~   "
34530|NCT02605057|"~     Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to~     compare and examine the amount of the drug in the upper layer of the skin with that of~     Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty~     adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in~     the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet®~     ointment will be applied to multiple test sites on the back of healthy Japanese male adults~     and the trial is designed to compare the amount of each of the active ingredients at steady~     state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of~     calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use~     of tape stripping.~   "
34531|NCT02605044|"~     The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI~     ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in~     second line treatment of patients.~   "
34532|NCT02605005|"~     The aim of this study is to investigate the relationship between the patient positioning in~     the beach chair position with consequential arterial pressure changes and their influence on~     regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in~     one group of patients and interscalene block in the second group of patients.~   "
34533|NCT02604992|"~     The primary objective of this study is to evaluate the comparative bioavailability of a test~     product of dronabinol oral solution administered under fed conditions to the reference~     listed drug (RLD) administered to participants under fed and fasted conditions.~      The secondary objective is to compare the onset of detectable dronabinol concentrations~     between dronabinol oral solution and the RLD.~   "
34615|NCT02603926|"~     The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a~     possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).~   "
34535|NCT02604966|"~     At the end of 2012, the Institute of Tropical Medicine in collaboration with National~     Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam~     province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the~     treatment of uncomplicated P. falciparum malaria infections, both in adults and in children.~     Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite~     clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia,~     where artemisinin resistance were previously reported . However, results from this study~     have to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has~     been criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™),~     Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results~     prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces~     as a Tier I area (credible evidence of artemisinin resistance) in May 2013. By end of 2014~     a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except~     for the south-eastern province of Binh Phuoc, artemisinin resistance has never been~     confirmed with an artemisinin based monotherapy in Central Vietnam.~      Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral~     artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing~     scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are~     treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day~     course of DHA-PPQ to effectively clear all parasites.~      The aim of the present study is to confirm artemisinin resistance in Central Vietnam by~     assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended~     dosage). The investigators will conduct a two-arm open label, randomized study, with one arm~     receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of~     DHA-PPQ.~   "
34536|NCT02604953|"~     Wills Eye Hospital Glaucoma Research Center will conduct a 1-year prospective study to~     assess the ability of a Short Duration Transient Visual Evoked Potential (SD- tVEP) and a~     Steady-State Pattern electro-retinogram (PERG) vision testing system to detect visual~     dysfunction in patients with ocular hypertension. The study aims to assess the reversibility~     of retinal ganglion cell (RGC) dysfunction after administering intraocular pressure (IOP)~     lowering treatment. The investigators hypothesize that SD-tVEP and PERG testing will help~     develop better treatment for glaucoma patients by increasing understanding of the~     physiological relationship of IOP and RGC in glaucomatous injury.~   "
34537|NCT02604940|"~     The purpose of the study is to determine whether a single bolus dose of dexmedetomidine~     administered during bariatric surgery has any effect on the amount of narcotic pain~     medications required by an individual after surgery. Patients who undergo weight loss~     surgery will be randomized into two groups - group one -dexmedetomidine group and group two-~     control group. Both groups will receive a standard anesthetic. Control group will receive~     weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen~     (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based~     dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic~     pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The~     Patient will then awaken after surgery in post anesthetic recovery unit and be given a~     patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain~     reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the~     electronic health record ( routine practice) in the two groups and compared for pain~     medicine requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score,~     respiratory rate, heart rate, blood pressure oxygen saturation and respiratory rate. All~     will be recorded at 30,60,90,120 and 240 minutes in the electronic medical record in PACU~     and compared between the two groups . All the data - Intra operative and Post -operative -~     Post Anesthesia Care Unit ( PACU) data will be retrieved from the electronic Medical record~     (EMR). All intra-operative data is automatically computed into the patients EMR. All PACU~     data is routinely entered into the EMR by the PACU nurse including the PCA data.~   "
34538|NCT02604927|"~     Paralympians competing in wheelchair sports may experience a very high glycolytic demand~     (and therefore acidotic environment) in their upper-body muscles, particularly in~     high-intensity disciplines. Previous studies from our group have shown that upper-body~     exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to~     other nutritional supplements capable of increasing buffering capacity. In line with this,~     have shown that upper-body muscle groups benefit more from artificially induced alkalosis~     than lower-body muscle groups. Although β-alanine appears to be an interesting and potential~     ergogenic supplement for paralympians, no study to date has assessed its potential in~     wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation~     on upper-body performance in wheelchair athletes.~   "
34539|NCT02604914|"~     An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that~     Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and~     to Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa~     Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube~   "
34540|NCT02604901|"~     The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a~     reminder device (Pillbox), and the combination of the two on adherence in adult patients who~     filled a prescription for oral medications to treat diabetes or hyperlipidemia.~   "
34541|NCT02604888|"~     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named~     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.~   "
34542|NCT02604875|"~     The circadian rhythm of copeptin will be examined in healthy subjects.~   "
34543|NCT02604862|"~     While the process of fibrosis is essential for normal wound healing, an excessive and~     uncontrolled 'fibrotic' response can result in impaired tissue structure and function. In~     other words, affected 'fibrotic' tissues are unable to heal back to normal and therefore~     don't work as effectively as they normally would.~      In the case of the lung, fibrosis can occur across large parts of the lung such as in~     conditions like Idiopathic Pulmonary Fibrosis (IPF) and sarcoidosis or it can occur in much~     smaller patches such as around the borders of some lung tumours. At the moment the~     investigators don't fully understand the mechanisms of fibrosis and so therefore cannot~     monitor or treat these conditions as effectively as the investigators could. Despite the~     significant global financial burden of these diseases, treatment options are very limited~     and monitoring of disease progression remains a real challenge.~      In an effort to address this problem, the research team have designed and synthesised an~     imaging agent (FIB ONE) that can detect fibrosis in the lung. FIB ONE will be used at very~     low concentrations in patients with a lung condition characterised by excessive activity of~     the fibroproliferative pathway either scheduled for a routine bronchoscopy or elective~     surgery. FIB ONE will be administered directly into the lungs during a bronchoscopy~     procedure and images of the lungs will be analysed. As part of this study, the research~     team's novel endomicroscopy detection system will be compared to equipment that is routinely~     used in the NHS when imaging the FIB ONE probe.~   "
34546|NCT02604823|"~     This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive,~     interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following~     48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
34547|NCT02604810|"~     This study was designed to determine a dose of weekly subcutaneously administered Immune~     Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%)~     that produces steady-state AUC of total IgG that is non-inferior to that of the regularly~     administered intravenous dose of Immune Globulin Injection (Human), 10%~     Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency~     subjects. This study was also designed to determine steady state trough total IgG levels~     after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the~     safety and tolerability of IGSC 20%.~   "
34548|NCT02604797|"~     Cesarean section may result in great trauma and postoperative pain. Besides incision pain,~     uterine contraction pain is another source of postoperative pain after cesarean section. In~     clinical practice, a large amount of uterine contraction agent is routinely applied after~     cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage,~     which also causes great uterine contraction pain. Acute pain is the risk factor of chronic~     pain, and may postpone the recovery from labour and influence the quality of life of~     parturient. Though various analgesia modules have been attempted, more than 20% parturients~     still experience severe postoperative pain, and pain management after cesarean section~     remains a challenge to anesthesiologists.~      This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on~     patient-controlled intravenous analgesia after cesarean section.~   "
34549|NCT02604784|"~     Single center, open label, non-randomized, single-arm, repeated single dose study to explore~     the efficacy, safety, and Overall Response Rate (ORR) of cisplatin, oxaliplatin and~     doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients~     (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers~     and in primary cancers of peritoneum.~   "
34550|NCT02604771|"~     This study is an epidemiological non-interventional trial that aims to evaluate standard~     daily practice in managing patients with arterial hypertension. The trial only records~     real-life clinical practice with no additional diagnostic or monitoring procedures.~      The study is purposed to collect the following Egypt-specific epidemiology data on~     hypertension: demographic data, patients' characteristics, and patients'~     management/treatment in order to reach its rationale.~   "
34551|NCT02604758|"~     The aim of the study was to determine the effect of the psychiatric nursing approach based~     on the Tidal Model on coping and self-esteem in people with alcohol dependency.~   "
34552|NCT02604745|"~     The main objective of this project is to determine intermediate-term echocardiographic~     outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical~     risk who have undergone mitral valve surgery for degenerative mitral regurgitation.~   "
34553|NCT02604732|"~     The study is designed to assess the need to stop Aspirin before laparoscopic inguinal hernia~     repair. It will consist of 2 groups: patients who continue to take Aspirin and patients who~     stop Aspirin 1 week before the surgery. Randomization will be by closed envelope method. The~     surgeon will be blinded for the usage of Aspirin. Primary outcome is the rate of~     post-operative seroma or hematoma within the fist 24 hours after surgery. Secondary outcomes~     are post-operative pain at regular intervals, post-operative seroma and hematoma after 24~     hours and other post-operative complications.~   "
34554|NCT02604719|"~     The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and~     Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with~     prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS~     at high risk for post partum hemorrhage~   "
34555|NCT02604706|"~     Background. A common alternative treatment for substance abuse is ear acupuncture. The aim~     of the study was to evaluate the short and long-term effect of auricular acupuncture on~     anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse.~     Method. Adults with substance abuse and psychiatric comorbidity were randomly assigned to~     either of two variants of auricular acupuncture - The National Acupuncture Detoxification~     Association protocol (NADA) or a local protocol (LP) - or relaxation training (controls).~     Primary outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity~     Index (ISI) with assessment before treatment and follow-ups after five weeks and three~     months. Secondary outcomes were drug use and addiction service utilization.~   "
34556|NCT02604693|"~     This study will provide important results for each aim, while also providing an integrative~     transcriptional and epigenomic profile of CBD.~      In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by~     determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells)~     in CBD compared to BeS and healthy controls. In addition, the Investigator will determine~     the impact of Be exposure on the methylation profile of CBD and BeS cells compared to each~     other and normal controls. This information will be used to define DM regions, genes and~     their networks.~      Using the cases and controls from Aim 1, we will evaluate the gene-expression from these~     same subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells~     with and without Be exposure. The Investigator will also integrate ENCODE/RE methylation,~     histone modification, and chromatin accessibility data as well as our genome-wide~     association study (GWAS) data to prioritize epigenetic marks and networks for confirmation~     and validation in Aim 3. In Aim 3, the Investigator will test the generalizability of their~     findings, explore the potential of methylation marks as biomarkers of disease in PBMCs and~     determine if change in methylation of these targets with AZA or folic acid affects key~     immune and regulatory pathways in a second set of CBD and BeS subjects. Throughout the Aims,~     the Investigator will use both fresh CD4+ T cells to directly assess disease relevance and~     Be-stimulated cultured CD4+ T cells (compared to unstimulated cultured T cells) to assess~     the impact of environmental exposure .~   "
34557|NCT02604680|"~     The objective of the study is to compare the safety and efficacy of multiple formulations of~     BLI1100 to a control group and placebo in treating patients with moderate-severe acne~     vulgaris.~   "
34558|NCT02604667|"~     The purpose of this study is to better understand the causes of stroke in people with~     cancer. Active cancer increases the risk of stroke. The investigators do not know exactly~     why this occurs but one possible reason is that people with cancer may have thicker blood~     than people without cancer. Thick blood can sometimes cause blood clots to form in the~     heart, which can then travel to the brain and cause stroke. This study is being done to help~     figure out why this and other causes of stroke occur in people with cancer. The~     investigators expect that information from this study will help doctors to more effectively~     prevent and treat stroke in individuals with cancer.~   "
34559|NCT02604654|"~     The purpose of the prospective study is to evaluate the effectiveness and safety of~     Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more~     than sixy hospitals all over China.~   "
34560|NCT02604641|"~     Objective of the study is to determine the influence of dietary supplementation with~     coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly~     assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose~     group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10~     with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia)~     will be used. Various skin parameters will be evaluated before the supplementation (the~     baseline), after 6 and after 12 weeks of supplementation. To evaluate the photoprotective~     potential of CoQ10 the minimal erythema dose (MED) will be determined before (the baseline)~     and after 12 weeks of the supplementation.~   "
34561|NCT02604628|"~     The purpose of this study is to determine the effect of a multifaceted antibiotic~     stewardship intervention on protocol adherence of moderate-severe community-acquired~     pneumonia.~   "
34562|NCT02604615|"~     A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent~     radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive~     chemoradiotherapy is the standard regimen in Western countries for patients with esophageal~     cancer who can't receive surgery or reject surgery. But in China because of its severer~     toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the~     chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to~     its characristic of low toxic reaction.~      The purpose of this study is to confirm the efficacy and safety of the different cycles(two~     cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous~     carcinoma radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from~     China within 2 years. The primary endpoint is overall survival and the secondary endpoints~     include progression-free survival, response rate, pathologic complete response rate and~     adverse events.~   "
34563|NCT02604602|"~     Objective is to analyze a possible association of coagulation factors peripartal with the~     occurrence of postpartum hemorrhage.~   "
34564|NCT02604589|"~     Rib fractures are common injuries in accident patients and can be associated with~     significant pain during recovery. If poorly controlled, pain from splinting due to rib~     fractures can result in difficulty in breathing leading to incomplete expansion of lung, and~     even the need to put a patient on a ventilator to help them breathe. Therefore, pain control~     is critical in managing patients with rib fractures. To date, many studies have shown the~     effectiveness of continuous intercostal nerve blockade (a slow release of pain medications~     at the site of injury that prevents the transmission of pain signals). This approach has~     never been studied in a randomized fashion in rib fracture patients, and has never been~     compared to patient-controlled narcotic pain medication, commonly used at many hospitals.~     The purpose of this study is to evaluate the effectiveness of the placement of an~     elastomeric infusion pump (a small, external, wearable balloon used to deliver medication~     over time) attached to a continuous infusion catheter or soaker catheter (a tube which~     releases the pain medication through tiny holes in it, right at the site of injury) to~     deliver local anesthetic medication to reduce pain caused by two or more rib fractures.~   "
34565|NCT02604576|"~     Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of~     fixed-dose combination of bromopride and simethicone versus isolated bromopride on research~     participants diagnosed with functional dyspepsia.~   "
34566|NCT02604563|"~     In this study the investigators will incorporate a wide range of clinical variables~     associated with aging to determine whether they are associated with mutation status~     independent of chronologic age. Clinically, aging can be operationalized using geriatric~     assessment, which entails a comprehensive multi-dimensional assessment of the health of an~     older adult, including measures of comorbidity, polypharmacy, functional status, cognition,~     depression, falls, social activities and social support. Given that aging is heterogeneous,~     geriatric assessment allows greater specificity for aging than chronological age alone.~   "
34567|NCT02604550|"~     The objective of this study is to compare the pain control benefit of two different types of~     nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.~   "
34568|NCT02604537|"~     The purpose of this study is to determine if corticosteriod injection modifies the natural~     course of de Quervain tendinopathy compared to a toradol injection.~   "
34569|NCT02604524|"~     The biggest challenges for glycemic control during the day time involve meals and exercise~     variations, which are impacted by age, fitness level, duration, intensity and history of~     exercise. Meal variability has the benefit that meals are typically announced and~     quantified. Glucose control around exercise, on the other hand, is more complicated if the~     patient doesn't announce a change in activity level.~   "
34570|NCT02604511|"~     This research study is studying a drug called ibrutinib as a possible treatment for~     untreated Waldenstrom's Macroglobulinemia (WM).~   "
34571|NCT02604498|"~     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose~     administration study design. Healthy subjects will be matched to moderate hepatic function~     impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which~     matches healthy with normal hepatic function according to the of subjects with impaired~     hepatic function as, after enrollment of subjects with moderate impaired hepatic function~     (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally~     single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before~     and after the administration to perform pharmacokinetic analysis and safety observation.~   "
34573|NCT02604472|"~     To investigate whether the additional induction chemotherapy (IC) to concurrent~     chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival~     (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for~     locoregionally advanced NPC.~   "
34574|NCT02604459|"~     Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip~     fracture and this complication is independently associated with increased morbidity,~     mortality, length of hospital stay, and placement in long-term care institutions. To date,~     the only intervention shown to be effective at minimizing postoperative delirium is a~     proactive geriatric consultation. This prospective randomized clinical trial will randomize~     160 adults, aged 65 years or older, to either optimized general anesthesia or usual general~     anesthesia care for hip fracture surgery to determine if the optimized anesthesia management~     reduces the severity of postoperative delirium.~   "
34575|NCT02604446|"~     This study will provide knowledge about the use of long-acting opioids for pain relief after~     primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone~     and placebo for effect on pain relief and side effects. The three study groups reflect the~     three different postoperative pain regimens that have been used the last years at St. Olavs~     Hospital, so investigators know that no patient will receive an inadequate pain treatment.~     The purpose of the study is to find which of the three treatments that gives the best pain~     relief with the least amount of side effects. The results will be of use for postoperative~     pain treatment for knee arthroplasty, but also for other types of major surgery. Similar~     studies that are not sponsored by pharmaceutical industry have not been published yet.~   "
34576|NCT02604433|"~     This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to~     determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC)~     versus placebo plus BSC in adults who require regular red blood cell transfusion due to~     (β)-thalassemia.~      The study is divided into the Screening/Run-in Period, double-blind Treatment Period,~     double-blind Long-term Treatment Period, and Post-treatment Follow-up Period.~   "
34577|NCT02604420|"~     Mortality in the major thrombotic microangiopathies (TMAs), TTP and aHUS, exceeds 90% unless~     rapidly diagnosed and appropriately treated. TMAs complicate 10-20% of allogeneic bone~     marrow hematopoietic stem cell transplants (alloHSCT), conveying inferior survival. Multiple~     etiologies have been proposed for these transplant-associated TMAs (TA-TMAs), but once~     infection, graft vs. host disease (GvHD), and drug effects have been ruled out, most are~     treated as TTP-like disorders using plasma exchange (PEx). But PEx has no impact on~     mortality in this setting. Clear definition of the pathophysiology of the TA-TMAs is~     required to guide effective treatment. Investigators hypothesize that an aHUS-type TMA,~     related to dysregulation of the alternative complement pathway, is involved and will be~     characterized by elevated plasma levels of C5b-9 and detectable C5b-9 deposition in bone~     marrow sinusoidal vessels. Investigators further hypothesize that treatment with inhibitors~     of terminal complement components will reverse the TMA in vivo, and block endothelial cell~     damage in our in vitro model systems. The data investigators generate from this~     observational study of TA-TMAs should enable prediction of their development prior to overt~     clinical manifestations, and guide appropriate therapy.~   "
34578|NCT02604407|"~     The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and~     37.5 mg) given to participants daily in the morning compared to placebo in the treatment of~     adults aged 18 to 55 years diagnosed with ADHD.~   "
34579|NCT02604394|"~     Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded~     atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial~     infarction (AMI).~      Timely restoration of perfusion and thereby myocardial salvage is the single most important~     objective in the management of patients with ST segment-elevation myocardial infarction~     (STEMI).~      To address these uncertainties, our study aims to evaluate the role of RT in patients who~     are most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative,~     and reproducible parameter; CMR-derived myocardial salvage. also, to determine whether~     Rheolytic Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to~     conventional PCI (with or without MTA) results in improved myocardial salvage; and to~     identify clinical and angiographic determinants of any difference observed between both~     treatment groups.~   "
34580|NCT02604381|"~     The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine~     Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on~     osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index~     Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of~     the knee.~   "
34581|NCT02604368|"~     The purpose of this study is to determine whether treatment of sickle cell patients with~     docosahexaenoic omega-3 acid (DHA) is effective in prevention of acute sickle cell crisis.~   "
34582|NCT02604355|"~     This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending~     dose and multiple-ascending dose, adaptive parallel study to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral~     administration in healthy participants and chronic hepatitis B patients.~   "
34583|NCT02604342|"~     This randomized active-controlled multicenter Phase III open-label study will evaluate and~     compare between treatment groups the efficacy of alectinib versus chemotherapy in~     participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy~     and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to~     evaluate and compare between treatment groups the central nervous system (CNS) objective~     response rate (C-ORR) in participants with measurable CNS metastases at baseline, as~     assessed by an Independent Review Committee (IRC).~   "
34584|NCT02604329|"~     Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for~     chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing,~     limits mucositis severity and associated pain. As its use is recommended in the treatment of~     radio induced mucositis in adults, the level of evidence in pediatric studies does not allow~     a precise treatment protocol. The investigators present here the protocol of a feasibility~     study in the haemato-oncology department of the Children University Hospital of Toulouse,~     with the view to a future efficacy study.~   "
34585|NCT02604316|"~     The proposed study will address the effect of developed novel food products through~     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability~     and gut health using in vivo studies and validating new in vivo approaches.~      Specifically in this protocol the investigators will address, in a short human intervention~     study the effect of a potentially satiating product on appetite, appetite biomarkers,~     particularly the influence on gut microbiota, tolerance and safety of the products in~     healthy obese and overweight participants in free living conditions.~   "
34586|NCT02604303|"~     Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery,~     which is the called the abdominal aorta. The purpose of this observational study is to~     identify whether a blood biomarker protein RhoA can predict which small AAA patients may~     need surgery in the future.~      Participating patients will receive an ultrasound and blood draw. The patients will be~     divided into expanding and stable aorta groups after determining each patient's aortic~     expansion rate. The blood RhoA levels and aortic expansion rates between both groups would~     then be compared to look for any relationships.~   "
34587|NCT02604290|"~     The purpose of this study is to determine whether the kinesio taping method is effective in~     the treatment of chronic (more than six months duration) low back pain.~   "
34588|NCT02604277|"~     The purpose of this study is to learn the environmental and psychological factors that~     impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims~     to identify treatments to reduce the suicidal behavior and improve quality of life through a~     6-week group-based intervention program.~   "
34589|NCT02604264|"~     To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC)~     patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end~     caps.~   "
34590|NCT02604251|"~     This is a multicenter, randomized, prospective, controlled study in patients having~     bilateral breast reduction. Objectives of the study are to evaluate the safety and efficacy~     of the KLOX BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the~     treatment of surgical wounds.~   "
34591|NCT02604238|"~     The primary aim of this study is to evaluate whether mid dose (safe dose) of Alteplase in~     addition to standard treatment with heparin (LMWH) in patients with pulmonary embolism (PE)~     at intermediate risk, it is effective to reduce:~        -  right ventricular dysfunction~        -  pulmonary hypertension 24 hours and 7 days after the treatment~        -  PE recurrence to 7days and 30 days after the treatment without increasing the incidence~          of bleeding intra-extracranial~   "
34592|NCT02604225|"~     A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with~     periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided~     prostate biopsy (Pain-Free TRUS B).~   "
34593|NCT02604212|"~     Patients with HBeAG positive, chronic Hepatitis B Virus (HBV) infection will receive either~     ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety~     and efficacy.~   "
34594|NCT02604199|"~     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 or~     placebo in combination with entecavir or tenofovir, and be evaluated for safety and~     efficacy.~   "
34595|NCT02604186|"~     Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common~     predominant feature of spasticity of the lower limbs. The clinical picture is composed of~     difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski~     sign, sphincter disturbances and various degrees of weakness as well as sensory~     disturbances.~      Spasticity is the symptom that provoques greater incapacity. Although there have been recent~     advances in the genetic and pathogenic characterization of SPG there is scarcity of~     therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement~     disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke.~      Therefore, the investigators propose the execution of a randomized, double-blind,~     placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over~     SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter~     walking test 8 weeks after injection. Each participant will be submitted to one injection~     session of Btx and one of placebo (consisting of sterile sodium chloride), each one~     separated by a period of 6 months. The primary and secondary outcomes will be evaluated by a~     blind investigator 8 weeks after each injection session.~   "
34596|NCT02604173|"~     This study is designed to be the first to examine the novel drug budesonide for prevention~     of acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent~     to high altitude. The investigators will accomplish these objectives with a prospective,~     double blinded view of a large population of hikers who are ascending at their own rate in a~     true hiking environment.~   "
34597|NCT02604160|"~     This study is not intended to treat anemia of chronic kidney disease but to determine the~     safety of the study drug, LY3113593.~      The study will also evaluate how much of the study drug gets into the blood stream, how long~     it takes the body to remove the study drug, and what effect the study drug has on the body.~      The study consists of up to three parts. Participants may only enroll in one part.~     Participants will receive up to four injections of LY3113593 or placebo into a vein. The~     study will last up to about 26 weeks including screening and follow-up.~   "
34598|NCT02604147|"~     Investigate the effects of Inspiratory Muscle Training on the physical performance and~     cardiorespiratory variables of wheelchair basketball players.~   "
34599|NCT02604134|"~     This pilot trial compares conventional restorations with a new strategy based on the medical~     management of caries using silver nitrate and fluoride varnish with no restorations.~   "
34600|NCT02604121|"~     Prospective study of diagnosis validation of a cytological technique. 200 patients with oral~     cavity cancerous and precancerous lesions will be enrolled.~      A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex®~     Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A~     microscopic double blind reading will be performed. A biopsy sampling will be carried out in~     accordance with current strategy of screening. The brushing diagnosis quality will be~     compared to the biopsy which is the gold standard.~   "
34627|NCT02603770|"~     The objective of this study is to compare laboratory tests profiles of a botanic drug~     XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy~     male volunteers between 18 and 50 years of age.~   "
34601|NCT02604108|"~     This training program is a part of Happy Family Kitchen Movement Project, which is a~     community-based research project with 3 main components for data collection - training~     programs, community-based family interventions and public education events. The training~     program involves various organizations, including non-government organizations and schools~     across districts in different regions of Hong Kong.~      In the study, the investigators would use training programs as a capacity building method~     and an essential media delivering the holistic health knowledge (positive psychology,~     physical activity, healthy diet) to the public. The project team will provide training~     program for the participants, including: (i) train-the-trainer workshops for the social~     service workers, who will conduct community-based family intervention programs; and (ii)~     train-the-trainer ambassadors for the volunteers who may assist to implement health-related~     activities for the public.~   "
34602|NCT02604095|"~     Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.~   "
34603|NCT02604082|"~     Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas~     de Porto Alegre from october 2011 until november 2015 .~   "
34604|NCT02604069|"~     A simple device that objectively assesses flap perfusion - either as a stand-alone tool or~     an adjunct to the current monitoring method - would be a tremendous improvement in detection~     of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In~     this study, the investigators aim to examine the accuracy and reliability of measuring~     interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an~     objective method of detecting postoperative flap tissue ischemia in patients undergoing free~     flap-based reconstructive surgery.~   "
34605|NCT02604056|"~     Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full,~     active intervention (featuring educational outreach offered to each prescriber and team~     members in the home) or standard quality improvement supports (including online audit and~     feedback reports for each prescriber in the home). The 'standard' quality improvement~     supports represent 'usual care' as these are to be launched province-wide; a concurrent~     control arm with no exposure to a quality improvement intervention is not feasible.~   "
34606|NCT02604043|"~     This is a pilot prospective cohort study of the incidence of supraglottic pH readings.~   "
34607|NCT02604030|"~     Our objective is to identify the possible changes of three-dimensional scapula movement~     during arm elevation in women after breast cancer surgery and subjected to a physical~     therapy intervention. Also to evaluate pain, upper limb function and quality of life.~     Methods: Will be evaluated 25 women with a clinical diagnosis of breast cancer and 25~     healthy controls women with no history of musculoskeletal disorders of upper limbs and~     matched with age and body mass index. Two pre-surgical evaluations in the month prior to~     surgical treatment of breast cancer and two post-surgical assessments are going to be~     assess: the first, after 4 weeks after surgery, when patients have received 8 sessions of~     physical therapy in upper limb; the second, after 8 weeks after surgery, when patients~     completed 16 sessions of physical therapy for shoulder complex . In each evaluation,~     bilateral scapular kinematics will be analyzed by an electromagnetic tracking device during~     arm elevation in scapula plane, in breast cancer group. Range of motion will by assessed by~     a digital inclinometer and muscle strength by a hand held dynamometer. Also, pain will be~     assessed by visual analog scale and upper limb function by DASH questionnaire. Quality of~     life is going to be evaluated by 36 questionnaire -item Short Form Health Survey (SF36).~   "
34608|NCT02604017|"~     This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with~     Genotype 1 hepatitis C virus infection without cirrhosis~   "
34609|NCT02604004|"~     The objective of this research is to check whether the test drug (lamivudine in the form of~     coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in~     the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both~     genres under fasting condition.~   "
34610|NCT02603991|"~     Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve~     stimulators for children and adolescent with refractory epilepsy.~   "
34611|NCT02603978|"~     The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a~     brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander~     and social norms intervention are effective at reducing alcohol use and sexual-related~     behaviors among college men mandated to receive an alcohol intervention by their university.~   "
34612|NCT02603965|"~     This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission~     tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate~     cancer undergoing surgery to remove the entire prostate and some of the tissue around it~     (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the~     lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal~     cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the~     body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and~     comparing them with cancer tissue obtained from surgery may help doctors learn whether~     Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are~     cancerous or benign, which may minimize the need for prostate biopsies.~   "
34613|NCT02603952|"~     The purpose of this study is to evaluate safety and tolerability of a single dose of~     MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and~     the safety and tolerability of a single dose of MEDI8852 alone in adult subjects with acute,~     uncomplicated influenza caused by Type A strains.~   "
34614|NCT02603939|"~     Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest~     cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately~     resulting in total joint replacement. In order to assess disease progression and plan~     surgery, x-rays are taken as part of routine practice. However x-rays provide limited~     information about formation of substructures and changes occurring during progression of~     disease. The proposed study aims to invite patients with OA of the hip or knee to~     participate in detailed examinations of their pain and their painful joint through~     interviews, blood and urine samples taken, MRI magnetic resonance imaging)and donating their~     waste tissue after joint surgery (all of old joint). Informed patient consent will be sought~     in all cases.~   "
34616|NCT02603913|"~     Pregnancy complications like pre-eclampsia (PE), pregnancy induced hypertension (PIH),~     intra-uterine growth restriction (IUGR) and preterm labor (PTL), (i.e. the major part of~     complications in pregnancy) are related to an impaired endothelial function. Endothelial~     dysfunction accounts for altered vascular reactivity, activation of the coagulation cascade~     and loss of vascular integrity. Nitric oxide (NO), a free radical molecule derived from~     L-Arginine by NOS (Nitric Oxide Synthase), is an endogenous endothelium-derived relaxing~     factor influencing endothelial function. In the placental circulation, endothelial release~     of NO dilates the fetal placental vascular bed and thus ensures feto-maternal exchange. The~     impaired endothelial function in pregnancy complications originates from production of~     inflammatory and cytotoxic factors by the ischemic placenta and results in oxidative stress~     and an altered bioavailability of NO. Measurement of endothelial function using peripheral~     artery tonometry and determination of ROS (reactive oxygen species) and RNS (reactive~     nitrogen species) using Electron Paramagnetic Resonance (EPR) gives an idea of the oxidative~     stress that took place and the degree of endothelial dysfunction that occurred during~     pregnancy.~   "
34617|NCT02603900|"~     The study is a prospective randomized controlled trial comparing local infiltration of~     analgesia in the knee joint and adductor canal catheters for postoperative analgesia~     following a primary Total Knee Arthroplasty (TKA).~   "
34618|NCT02603887|"~     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to~     control intermediate- or high-risk smoldering multiple myeloma (SMM). The safety of this~     drug will also be studied.~   "
34619|NCT02603874|"~     The current method of incision localization in many surgical procedures requires a doctor to~     reference a medical image, such as an X-ray, to judge where on the body an incision should~     be made. However, the precise information of the scan is not shown on the patient's skin.~     Surgeons commonly use palpation to locate the point of incision. They may feel for the area~     directly or find landmarks under the skin and estimate the location from there. This can be~     challenging due to the difficulty of feeling and distinguishing each vertebra, especially~     for new surgeons, since palpation is a skill derived through experience.~      If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the~     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer~     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and~     the patient to radiation. Many fluoroscopic images may be required in a single procedure.~     The purpose of this study is to test the efficacy and benefits of a new medical device that~     will aid in radiological localization. The hypothesized outcome would be smaller incisions,~     faster localization and a reduction in fluoroscopy use.~      By identifying the efficacy of this new medical device, Target Tape, there is the~     potential outcome of making smaller incisions, faster localization, a reduction in~     fluoroscopy use and a reduced chance in surgical error and the associated costs.~      Target Tape is a non invasive device that is in a grid format that is placed against the~     subject's skin. The grid pattern will then appear on the medical imaging scan. The medical~     practitioner can correlate device grid on the body to the medical scan image to make their~     incisions in more accurate locations.~   "
34620|NCT02603861|"~     This study will evaluate the effect of single doses of LY3154207 on the amount of time it~     takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much~     LY3154207 gets into the blood stream and how long it takes the body to remove it.~     Information about any side effects that occur will be collected. Each participant will~     complete four study periods, which will last a total of about 8 weeks.~   "
34621|NCT02603848|"~     Morphine is now the most commonly used opioid in children for pain management even though~     the safety of morphine use in children is a primary concern for parents as it is perceived~     to have more associated risks. Ibuprofen and other Non-Steroidal Anti-Inflammatory Drugs~     (NSAIDs) have also been shown to be effective for the management of postoperative pain with~     fewer associated adverse effects. However, there have been concerns that utilization of~     ibuprofen alone may lead to inadequate pain management. Evidence of whether ibuprofen is~     equally effective as morphine for postoperative pain control in pediatric inguinal surgery~     is lacking and needs to be further explored as a measure to potentially reduce opioid~     exposure in children. To determine which drug is more effective for relieving post-operative~     pain, this trial will compare the effectiveness of ibuprofen and morphine at reducing~     post-operative pain, and the amount of analgesic use required post-surgery.~   "
34622|NCT02603835|"~     The primary objective of the study is to collect confirmatory data supporting the safety and~     effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI)~     patients who have undergone successful percutaneous coronary intervention (PCI) with~     stenting within six hours of experiencing AMI symptoms.~   "
34623|NCT02603822|"~     The investigators' overall objective with this study is to determine performance~     characteristics of small intestine permeability measurement using 13C mannitol and 12C~     (regular) mannitol.~   "
34624|NCT02603809|"~     The main objective of the study is to explore the effects of ERA - at different dose~     strengths - on the efficacy, safety and tolerability in subjects with essential hypertension~   "
34625|NCT02603796|"~     Facial scans of newborns will be performed before and after implementation of respiratory~     support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel~     Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.~   "
34626|NCT02603783|"~     Reflux is common, especially after large meals. In general, this can do no harm. However, if~     reflux occurs often and causes troublesome symptoms and or complications, it is called~     gastroesophageal reflux disease (GERD). Long exposure to gastric acid causes the mucosa of~     the esophagus to loose its integrity, which is thought to lead to the symptom of heartburn.~     Several food products can also impair the esophageal mucosa integrity and thereby influence~     reflux symptoms. One of these products is capsaicin, the pungent ingredient of red peppers.~     Use of capsaicin often leads to worsening of complaints in patients with GERD and can cause~     symptoms in healthy volunteers, possibly due to its effect on the mucosal integrity.~      In this study the investigators want to investigate the effect of capsaicin infusion on~     mucosal integrity. The investigators will evaluate mucosal impedance and the histology of~     the esophageal mucosa. In addition, the investigators also aim to assess the involvement of~     the TRPV1 receptor by evaluating the possible release of neuropeptides in the esophageal~     mucosa.~   "
34628|NCT02603757|"~     This is a pilot study to test whether there is an association between baseline Vitamin D~     levels, Vitamin D supplementation and survival in patients with stage III colon and stage~     II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal~     stage II or III cancer that require chemotherapy will be screened and 60 patients will be~     enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000~     IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients'~     Vitamin D levels will be checked throughout supplementation then followed for 5 years with~     occasional Vitamin D testing and surveying in order to collect information on recurrence and~     survival outcomes.~   "
34629|NCT02603744|"~     The goal of this study is to determine safety and tolerability and of intra-ovarian~     injection of adipose derived stromal cell in women with premature ovarian failure and to~     study the preliminary efficacy ADSCs intra ovarian injection on ovarian function~     improvement.~   "
34630|NCT02603731|"~     This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU)~     and to identify risk and preventive factors associated with development of delirium.~      Especially, the investigators want to investigate if an imitated natural light/dark cycle~     influences frequency of delirium.~   "
34631|NCT02603718|"~     The purpose of this study is to investigate the efficacy of a simple and easy to use tool~     that can extract relevant attention-related markers - Brain Engagement Index (BEI) from~     ongoing EEG. During standard rehabilitative physical therapy sessions.~   "
34632|NCT02603705|"~     The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in~     opioid-experienced patients with moderate-to-severe chronic noncancer pain.~   "
34633|NCT02603692|"~     In this research study the investigators want to learn more about the quality of life~     before, during and after cancer treatment in patients with central nervous system brain~     tumors. Often CNS tumors and cancer treatment can cause many physical and emotional problems~     and side effects. Some of these problems and treatment side effects can cause a change in a~     patient's qualify of life and overall well-being. Quality of life questionnaires are used to~     measure well-being and ability to carry out daily activities by asking patients to answer~     several questions about their physical, emotional, and social well-being.~      In this research study we want to find out if patient's answers to these questions change~     over the course of your treatment. We also want to see if doctors and nurses can use these~     answers to the questions to help patients feel better and increase their activity during~     cancer treatment.~   "
34634|NCT02603679|"~     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy~     using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib~     and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover.~     During the 24-weekly treatment period, clinical and radiological evaluations are performed~     repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response~     or due to toxicity. A translational subprotocol is a mandatory part of the study protocol,~     except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly~     courses of chemotherapy with a combination of epirubicin and cyclophosphamide.~   "
34635|NCT02603666|"~     The aim of the study is to find CF patients at risk for cystic fibrosis related liver~     disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with~     histological evaluation of liver biopsy if present.~   "
34636|NCT02603653|"~     Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease~     is responsible for increased morbidity and mortality. Recent studies have pinpointed the~     frequency of somatic sequelas and persistent alteration in quality of life despite the cure~     of the disease. More specifically, a few studies have described persistent psychopathology,~     maladaptive personality and cognitive impairments in patients with a history of Cushing's~     disease. Among these, hippocampal memory deficits have been found in the majority of~     studies, a finding that is consistent with the alterations described in hippocampal neurons~     during chronic exposure to glucocorticoids. However, the tools currently available to assess~     hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and~     to analyze or may lack of diagnostic sensitivity. The investigators have recently developed~     an original tool, the virtual radial task in 3D, which has shown to be reliable to detect~     subtle alterations in hippocampal-dependent memory in several human diseases. The primary~     aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory)~     in patients cured of Cushing's disease for at least one year using the virtual radial task~     in 3D and to compare it with that obtained with classical cognitive tests.~   "
34637|NCT02603640|"~     Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the~     population. It is a very invalidating disease, with high impact on quality of life. In a~     large proportion of cases, medication cannot prevent seizures; surgical removal of the~     regions responsible for seizures is then the only way to cure patients. However, results~     crucially depend on the correct delineation of the epileptogenic zone.~      In this context, computational modeling, under the form of a virtual brain is a powerful~     tool to investigate the impact of different configurations of the sources on the measures,~     in a well-controlled environment.~      In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography)~     and EEG (Electroencephalography) fields produced by different configurations of brain~     sources, which will differ in terms of spatial and dynamic characteristics will be offered~     to participants. The research hypothesis is that computational and biophysical models can~     bring crucial information to clinically interpret the signals measured by MEG and EEG. In~     particular, the hypothesis can help to efficiently address some complementary questions~     faced by epileptologists when analyzing electrophysiological data.~      The strategy will be three-fold:~      i) Construct a virtual brain models with both dynamic aspects (reproducing both~     hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and~     a realistic geometry based on actual tractography measures performed in patients ii) Explore~     the parameter space though large-scale simulations of source configurations, using parallel~     computing implemented on a computer cluster.~      iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and~     intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will~     be tuned on SEEG signals, and tested versus the surface signals in order to validate the~     ability of the models to represent real MEG and EEG signals.~      The project constitutes a translational effort from theoretical neuroscience and mathematics~     towards clinical investigation. A first output of the project will be a database of~     simulations, which will permit in a given situation to assess the number of configurations~     that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and~     major - output of the project will be to give the clinician access to a software platform~     which will allow for testing possible configurations of hyperexcitable regions in a~     user-friendly way. Moreover, representative examples will be made available to the community~     through a website, which will permit its use in future studies aimed at confronting the~     results of different signal processing methods on the same 'ground truth' data.~   "
34638|NCT02603627|"~     This study will investigate the prevalence of chronic obstructive pulmonary disease (COPD)~     in patients who are newly diagnosed with lung cancer and compare it to the prevalence of~     COPD in controls recruited from a smoking cessation clinic.~   "
34639|NCT02603614|"~     CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover~     design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate~     renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled~     subjects will begin with Infusion Period A where they will receive up to 7 days of~     continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the~     Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B~     where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions~     of cenderitide or placebo.~   "
34640|NCT02603601|"~     This randomized controlled trial is designed to test the feasibility and efficacy of a novel~     10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and~     psychosocial outcomes in patients who have undergone bariatric surgery.~      Primary hypothesis:~      Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5~     years post-surgery will be willing to participate in this 10-week intervention. The~     investigators expect a high adherence rate (>70%) and no issues with meeting recruitment~     goals.~      Secondary hypotheses:~      Patients assigned to the MBI will show greater improvement in a) weight control (defined by~     differences in body weight between baseline and follow-up); b) eating behaviors (binge~     eating, emotional eating); and c) psychosocial measures (quality of life, depression,~     perceived stress, eating self-efficacy, coping ability) than a standard lifestyle~     intervention (1 hr lifestyle counseling).~      Patients assigned to the MBI intervention will show greater improvement in biomarkers of~     stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP),~     interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a~     standard lifestyle intervention.~      Food-related attentional bias as measured by the food-related Stroop task will be~     differentially affected among patients assigned to the MBI as compared with the intensive~     lifestyle intervention and standard lifestyle intervention.~   "
34641|NCT02603588|"~     Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in~     treatment of nasal inflammatory disease, but the mechanisms remain largely unknown.~     Investigators aimed to assess the effects of SPG acupuncture for nasal ventilation function~     and autonomic nervous system in health volunteers. The randomized, double-blind, controlled~     clinical trial enrolled healthy volunteers.Healthy subjects were randomly assigned to either~     active SPG-acupuncture group or sham-acupuncture group. All subjects were assessed for~     self-reported nasal ventilation, nasal patency (nasal airway resistance (NAR) and nasal~     cavity volume (NVC)), exhaled nasal nitric oxide (nNO) before and after acupuncture.~     Meanwhile, in order to explore underlying mechanisms of SPG acupuncture, the changes in~     neuropeptides (substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y~     (NPY)) in nasal secretions were investigated at baseline, 30 minutes, 2 hours, and 24 hours~     after acupuncture.~   "
34642|NCT02603575|"~     Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The~     effects and safety of caspofungin and corticosteroids is not certain in this population. All~     Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin~     and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is~     28 day mortality, the second outcome are time of respiratory rate decreases to less than 25~     breath per minute, body temperature lower than 37.3℃.~   "
34643|NCT02603562|"~     The purpose of this study is to assess the safety and biological activity of ATYR1940 in~     patients with early onset facioscapulohumeral muscular dystrophy (FSHD).~   "
34644|NCT02603549|"~     Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for~     spontaneous intracranial hypotension, leading to positional headache patterns. Typical~     magnetic resonance imaging findings include subdural fluid collections, enhancement of~     pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the~     brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous~     cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the~     investigators would like to like to assess the clinical manifestations and neuroimaging~     abnormalities of SIH patients with regard to the pituitary gland. Specifically, the~     investigators are looking to analyze the compression of the pituitary stalk and conduct a~     systemic evaluation of pituitary function in SIH patients.~   "
34645|NCT02603536|"~     WelTel Oak Tree is a repeated measures study that enrolled 85 HIV+ individuals from the Oak~     Tree Clinic at BC Women's Hospital. Participants were be provided with a cell phone and/or~     unlimited text messaging capability if they do not have it already, and for one year~     received a weekly text message stating How are you. Participant problems and non-responses~     were be followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV~     medication adherence and attendance at appointments was collected for the year prior to the~     intervention and during the intervention for comparison. Data assessing quality of life was~     also collected at three points during the one year study period. Cost effectiveness and cost~     benefit of the intervention is being studied to assess feasibility of transferring the~     intervention to a programmatically funded facet of patient care.~   "
34646|NCT02603523|"~     The efficacy of exercise programs to prevent falls among older people is well documented in~     the literature. However, older people's adherence to these exercise programs has been~     reported to be suboptimal, varying between 21% and 74%. In addition, about 45% of people~     aged over 60 years do not meet the minimum recommended level of physical activity. In this~     context, dance is a promising alternative to traditional exercise programs, as it can~     positively influence important risk factors for falls, such as sedentary lifestyle, balance~     impairments and muscle weakness. Nevertheless, a recent systematic review conducted in this~     area show that the lack of randomized clinical trials as well as the low methodological~     quality of existing studies do not allow to reach definitive conclusions on the real effects~     of dance on risk factors for falls. A type of dance that is becoming popular among the older~     population in Brazil is the Senior Dance. Senior Dance classes consist of different~     choreographies, which include rhythmic and simple movements with rhythmic folk songs. The~     concentration required to learn the choreographies challenges balance, motor coordination~     and cognitive function. Thus the present study is a randomized clinical trial aiming to~     investigate the Senior Dance effect on balance, mobility and cognitive function, compared~     with a control group, among older people living in the community. A total of 82 subjects~     will be randomly allocated into two groups. The intervention group will participate in a~     12-week, twice-weekly group-based program of Senior Dance, while the control will be~     encouraged to maintain their current routine activities. Outcomes measures (balance,~     mobility and cognitive function) will be evaluated before and after the intervention by an~     assessor blinded to group allocation. The results of this study will assist health~     practitioners when prescribing intervention for the older population.~   "
34861|NCT02600676|"~     This is a randomized, double blind, placebo controlled study of the effect of Sacral~     Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic~     nocturnal enuresis (MNE).~   "
34647|NCT02603510|"~     Primary Objective:~        -  Assess the safety of SAR342434 and Humalog when used in external pumps.~      Secondary Objectives:~        -  Intervals for infusion set changes.~        -  Incidence of insulin pump alarms for infusion set occlusion.~        -  Patient observation of infusion set occlusion.~        -  Adverse events including bruising at the infusion site and injection site reactions.~   "
34648|NCT02603497|"~     The objective of this study is to compare the pharmacokinetics of ASP015K in patients with~     impaired renal function and subjects with normal renal function.~   "
34649|NCT02603471|"~     The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone,~     is a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral~     support program delivered via text-messaging.~      It is expected that the text messaging intervention will reduce alcohol use and HIV-risk~     behaviors. The investigators also hypothesize that the intervention will improve adherence~     to HIV treatment and naltrexone.~      To test the effects of the intervention on these target outcomes, 25 participants receiving~     the text messaging intervention will be compared to 25 participants receiving an~     informational pamphlet. The pamphlet will contain information about the importance of HIV~     treatment adherence, reducing HIV risk behaviors, and health consequences associated with~     alcohol use.~      By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled~     with coping skills to promote abstinence from alcohol, the text messaging intervention may~     provide a promising, cost-effective, and easily deployable behavioral support program for~     alcohol users who are HIV-infected.~   "
34650|NCT02603458|"~     This study seeks to examine the effectiveness of NRX-1074 in the treatment of negative~     symptoms and cognition in schizophrenia compared to other agents at the glycine site which~     have demonstrated inconsistent results for negative symptoms. In addition to testing~     efficacy, we will examine the time course of response of symptoms as well as any effects on~     memory consolidation.~   "
34651|NCT02603445|"~     This is a phase Ib multi-center, open-label study: escalation part followed by expansion~     part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety~     and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.~      Approximately 65 patients are to be enrolled.~      The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab~     abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic~     regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib.~     In addition Bayesian regression models will be used to estimate the dose-exposure~     relationships for both BCL201 and idelalisib in order to guide the escalation steps. A~     Bayesian method for the expansion part will be used for the primary activity objective.~      The study data will be analyzed and reported based on all patients' data of the escalation~     and expansion part.~   "
34652|NCT02603432|"~     The main purpose of this study is to compare maintenance treatment with avelumab plus best~     supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in~     patients with locally advanced or metastatic urothelial cancer that did not worsen during or~     following completion of first-line chemotherapy.~   "
34653|NCT02603419|"~     This is a Phase 1b dose-finding study to evaluate the pharmacokinetics, pharmacodynamics,~     and preliminary antitumor activity of avelumab (MSB00100718C) in adult patients with~     relapsed or refractory classical Hodgkin's Lymphoma (cHL). Patients enrolled in this study~     are required to have failed a prior course of high dose chemotherapy as a part of a~     first-line salvage chemotherapy regimen for cHL. The primary purpose of this study is to~     assess the pharmacokinetics, biological activity and early signs of efficacy of various~     avelumab dosing regimens in patients with cHL.~   "
34654|NCT02603406|"~     Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in~     patients with cerebral perfusion deficits (NIMBUS trial)~   "
34655|NCT02603393|"~     This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium~     (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with~     moderate to severe COPD~   "
34656|NCT02603380|"~     This qualitative study aims to evaluate the usability of a smartphone application called~     DelApp. The study will assess usability and acceptability of the software app by asking 40~     clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback~     will be collected through semi-structured interviews with the clinicians. The feedback will~     be used to optimise the software application in preparation for formal validations studies.~   "
34657|NCT02603367|"~     This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and~     opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver~     intervention in improving communication and reducing distress in caregivers of patients with~     lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to~     difficulty communicating with family, friends, and healthcare providers, or feeling unable~     to communicate openly. A communication intervention that improves the caregiver's ability to~     communicate with patients and healthcare providers may help reduce caregivers' psychological~     distress and improve the health outcomes of patients.~   "
34658|NCT02603354|"~     The purpose of this clinical study was to evaluate, the effectiveness and sensitivity~     post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light~     activated bleaching agent, the impact of shorter interval times on tooth sensitivity and to~     compare the efficacy with 2 different application protocols. This is a clinical randomized~     double-blind split-mouth study. 31 patients were treated with: one upper hemi arcade with~     one application of 36 minutes and the other hemi arcade with 3 applications of 12 minutes~     each with a 6% hydrogen peroxide. Two sessions were appointed with 48h of intervals between~     them. Tooth colour was registered by VITA Classical amd VITA Bleach guide by two blinded~     assessors in the beginning, immediately after each session. Tooth colour variation and~     sensitivity were compared between both application protocols~   "
34659|NCT02603341|"~     A pragmatic randomized clinical trial of patients with locally advanced breast cancer~     randomized to either proton or photon therapy and followed longitudinally for cardiovascular~     morbidity and mortality, health-related quality of life, and cancer control outcomes.~     Quality of life is the outcome measure for the estimated primary completion date of~     November, 2020.~   "
38311|NCT02555592|"~     The purpose of this study is to identify the treatment outcomes of surgical resection with~     sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell~     lung cancer and N2 disease at only the sub- or para-aortic level.~   "
34660|NCT02603328|"~     The study aims to demonstrate that extended course atorvastatin therapy reduces lesional~     iron deposition without increasing the risk of rebleeding (acute hemorrhage) in patients~     with cerebral cavernous malformation (CCM). Subjects will be randomized to daily~     atorvastatin (20,40 or 80mg PO) or placebo and followed for 36 months, or until a clinically~     overt CCM hemorrhage or attrition from drug related adverse events. Subjects will undergo a~     total of four MRI scans with biomarker studies, and serial clinical assessments.~   "
34661|NCT02603315|"~     The purpose of this study is to To assess the correlation between the predictive factor of~     vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate,~     and overall survival) .~   "
34662|NCT02603302|"~     This is a one arm study where patients with locally advanced rectal cancer will receive~     neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up~     to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total~     mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic~     complete response).~   "
34663|NCT02603289|"~     The purpose of this study is to demonstrate that changing aligners weekly provides similar~     results to changing aligners every two weeks.~   "
34664|NCT02603276|"~     A large body of evidence confirm the cholesterol lowering effect of phytosterols and red~     yeast rice. Because their mechanisms of action mime the ones of chemical statins and~     cholesterol absorption inhibitors, it is plausible that their association will provide a~     more relevant (and safe) LDL cholesterolemia reduction.~   "
34665|NCT02603263|"~     Encouraging individuals to eat fruit and vegetables is difficult. However, recent evidence~     suggests that using social-based information might help. For instance, it has been shown~     that if people think that others are eating lots of fruit and vegetables, that they will~     consume more food to match the 'norm'.The purpose of this study was to determine whether~     social norm messages could be used to enhance vegetable purchases in workplace restaurants,~     in an observational study.~   "
34666|NCT02603250|"~     The purpose of this study is to evaluate the use of a noninvasive Hb device (Pronto® with~     DCI-mini™ sensors) as an accurate method for measuring Hb levels among children between 6~     and 59 months against the standard reference hematology analyzer. The secondary purpose is~     to evaluate the accuracy of two HemoCue® Hb 201+ capillary blood collection methods against~     the standard reference hematology analyzer.~      The study hypothesizes that the Pronto® with DCI-mini™ sensor will approximate Hb values~     within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not~     anemic with less than 31% disagreement when compared to the standard reference hematology~     analyzer among children 6 to 59 months of age. Additionally, the two different HemoCue® Hb~     201+ capillary blood collection methodologies will both approximate Hb values within ±1.0~     g/dL and secondly, it will correctly classify participants as anemic or not anemic with less~     than 35% disagreement when compared to the standard reference hematology analyzer among~     children 6 to 59 months of age.~   "
34667|NCT02603237|"~     The study will compare plasma and urine post-prandial metabolomics after fat and glucose~     oral load according to lifestyle factors.~   "
34668|NCT02603224|"~     The primary objective of this study is to evaluate the safety and tolerability of the~     investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the~     activity of a molecule called miR-29 that decreases the expression of collagen and other~     proteins that are involved in scar formation. MRG-201 is being studied to determine if it~     can limit the formation of fibrous scar tissue in certain diseases.~      MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a~     short skin incision. Volunteers may receive one or several doses of MRG-201, and will be~     monitored for local reactions in the skin, signs or symptoms of adverse effects on the body,~     and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected~     to study how cells in the skin respond when exposed to MRG-201.~   "
34669|NCT02603211|"~     The aim of this study is to see how well a tactile imaging sensor will detect for breast~     masses compared to traditional mammography and/or ultrasound. This device may allow a~     simple, convenient method to screen for breast tumors. This data will be used to check the~     feasibility of using the device to detect breast tumors.~   "
34670|NCT02603198|"~     Dental treatments, particularly third molars extraction, can become extremely uncomfortable~     and painful. They are associated to anxiety, fear and many other unpleasant sensations.~     During surgery, patients can present cardiorespiratory repercussions of these sensations.~     This fact generally justifies the employment of methods of monitoring and appliance of safer~     therapeutic alternatives. Local anesthetics are the most frequently drugs used in dentistry.~     Vasoconstrictors, particularly epinephrine, are important components of anesthetic solutions~     to increased time for anesthetic absorption and consequently increasing the duration of~     anesthesia. The use of smaller amounts of anesthetic solution can reduce the risk of~     systemic toxicity, however decrease the total surgical time. It is well known that the~     amount of epinephrine injected into patients during anesthetic procedures can produce~     adverse hemodynamic effects. Levonordefrin was adding to dental cartridges promising to~     reduce cardiac stimulation due it less β activity, and maintain the same clinical and~     systemic effects. But some studies for maxillary or intraosseous infiltrations showed no~     difference in heart rate and any anesthetic success over epinephrine. Thus, this study aims~     to compare the clinical efficacy and safety of anesthetic mepivacaine 2% with epinephrine~     1:100,000 or 1:20,000 levonordefrin employing a clinical trial model of third molars~     extractions in healthy adults.~   "
34671|NCT02603185|"~     This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential~     ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of~     ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3,~     respectively. Food effect following a single oral dose will be evaluated in Part 2.~   "
34684|NCT02603016|"~     This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast~     carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE~     compound,120 patients will recrive Maitake mushroom extract compound,120 patients will~     recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of~     Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma~   "
46847|NCT02443844|"~     The purpose of this study is to compare medical and surgical treatments of benign prostate~     hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence~     and progression.~   "
34672|NCT02603172|"~     GSK3039294 has been developed in order to offer an orally available alternative to~     parenteral CPHPC (GSK2315698 [metabolite of GSK3039294]) for plasma serum amyloid P~     component (SAP) depletion prior to use of anti SAP monoclonal antibody (mAb) in the~     treatment of systemic amyloidosis. This phase 1 study is intended to study safety,~     tolerability and pharmacokinetic (PK) profile of GSK3039294 in humans. This study consists~     of three parts. Part A will evaluate safety and tolerability of single doses of GSK3039294~     in healthy subjects, Part B will evaluate safety and tolerability of repeat doses of~     GSK3039294 in healthy subjects, and Part C will evaluate safety and tolerability of repeat~     doses of GSK3039294 in subjects with systemic amyloidosis. Part A is a single dose, open~     label, dose escalation study. Two cohorts of subjects will be enrolled to provide data from~     6 subjects per cohort and up to 4 different doses (2 dose levels per cohort) of GSK3039294~     will be tested. For Cohorts 1 and 2, each subject may take part in two dosing periods. Part~     B is repeat dose, open label, dose escalation study. Sufficient number of subjects will be~     enrolled in Cohort 3a to ensure 6 completers (Cohort 3b will be conducted if required) and~     GSK3039294 will be administered repeatedly for a total of 21 days. Each subject will take~     part in a single study period. In Part C a single dose level of GSK3039294 will be tested~     for 21 days repeat dose, in 12 subjects with systemic amyloidosis. Each subject will take~     part in a single study period. The total duration for Part A is approximately 8 weeks, Part~     B is approximately 8-9 weeks, and Part C is approximately 13 weeks.~   "
34673|NCT02603159|"~     Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the~     standard in Western countries in esophagus cancer.But in China because of its toxic~     reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely~     used in the chemotherapy of esophageal cancer.~      The purpose of this experiment was to study the different cycle on capecitabine with~     chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years~     study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival~     and the secondary endpoints include progression-free survival, response rate,pathologic~     complete response rate and adverse events.~   "
34674|NCT02603146|"~     The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective~     for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have~     elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP).~      The following recruitment strategies will be employed towards identifying healthy subjects~     with elevated anti-cyclic citrullinated peptide 3 (anti-CCP3) levels:~      -Pre-screening:~        -  first degree relatives of patients with RA;~        -  subjects at health-fairs; and~        -  identification of subjects with elevated anti-CCP3 levels in the absence of~          inflammatory arthritis in rheumatology clinics.~   "
34675|NCT02603133|"~     Resilience means a healthcare provider's ability to cope, recover, and learn from stressful~     events, as well as their access to resources that promote health and well-being. Neonatal~     intensive care unit (NICU) health professionals' need to have particularly good resilience,~     because their work is extremely stressful and their patients, fragile preterm infants,~     require their undivided attention. The investigators propose a feasible and engaging~     intervention to enhance resilience among NICU health professionals promoting their ability~     to provide safe care.~   "
34676|NCT02603120|"~     This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and~     abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC~     as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.~   "
34677|NCT02603107|"~     This study will evaluate the safety and efficacy of switching to a fixed dose combination~     (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a~     regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in~     HIV-1 infected adults who are virologically suppressed.~   "
34678|NCT02603094|"~     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to~     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general~     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of~     this study and can be investigated in children undergoing elective procedures in general~     anaesthesia and intubation without inconvenience or additional invasive procedure and hence~     without additional risk~      Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication~     before anaesthesia induction than in those that drink until 2 hours before anaesthesia~     induction~   "
34679|NCT02603081|"~     This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared~     to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's~     disease.~   "
34680|NCT02603068|"~     This multicenter, randomized, open-label study will assess the safety and efficacy of oral~     treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary~     fibrosis.~   "
34681|NCT02603055|"~     Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly~     infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to~     15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E~     vaccine.~      This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial.~     This study will determine the safety and immunogenicity of the investigational recombinant~     hepatitis E vaccine in healthy adults between 16 and 65 years.~   "
34682|NCT02603042|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Hypophosphatasia disease from plasma~   "
34683|NCT02603029|"~     Objective of the study is to determine the influence of the cream with Silver fir wood~     (Abies alba) extract (Belinal) on the skin parameters and functions in comparison to the~     placebo cream. 10 healthy female subjects will use the test cream on one half and placebo~     cream on the other half of the face and of the gluteal part twice a day for 12 weeks.~     Various face skin parameters will be evaluated before the cream use (the baseline), after 6~     and after 12 weeks of the cream use. To evaluate the photoprotective potential of Belinal~     the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks~     of the cream use at the gluteal area.~   "
34685|NCT02603003|"~     Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor~     cells(CTCs) play a key role in the process of distant metastasis. The investigators' study~     will elaborate the clinical significance of CTCs intervented by Traditional Chinese~     Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and~     recurrence, individual treatment and prognosis and so on, in order to provide a new~     direction for the treatment of lung cancer.~   "
34686|NCT02602990|"~     A non-interventional multicentric study for patients with a cerebral AVM for which~     endovascular treatment is indicated.~   "
34687|NCT02602977|"~     In a wide range of auto-inflammatory and infectious diseases attenuation of the immune~     response could be beneficial. Remote ischemic preconditioning (RIPC) has been identified as~     a means of protecting patients undergoing cardiac surgery from perioperative myocardial~     ischemic damage. This protection can be divided in a `first window of protection` directly~     after preconditioning and a `second window` that protects patients 12-48 hour after~     preconditioning. Repeated RIPC might have additional value, possibly by combining beneficial~     effects of the first and second windows of protection. The mechanisms behind these effects~     are under investigation, but attenuation of the inflammatory response is a major candidate.~     However, this has not yet been demonstrated in the setting of systemic inflammation in~     humans in vivo. This study aims to investigate the effects of (repeated) ischemic~     preconditioning on inflammation during human endotoxemia.~   "
34688|NCT02602964|"~     Live kidney transplantation is first choice for patients with end-stage kidney disease.~     Therefore, the safety and well-being of kidneys donors are highly important objectives in~     live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and~     therefore also concomitant use of opioids.~   "
34689|NCT02602951|"~     The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the~     vascular anatomy. These sequences, widely used in clinical routine have shown their utility,~     in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences~     allow to quantify arterial parameters such as the speed of the circulating flow. By allowing~     an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR~     sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in~     term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the~     detection of vascular lesion and complete the exploration of the cervico-encephalic vascular~     pathologies by providing hemodynamical measures not yet accessible in clinical settings.~      In this context, the aim of the study is to evaluate the feasibility and the clinical~     usefulness of this 4D Flow technique to image brain vascular disorders including steno~     occlusive disorders. The evaluation will include several steps: 1/ optimization of~     acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for~     the post-processing 3/ feasibility for imaging of brain vascular disorders.~   "
34690|NCT02602938|"~     The purpose of this study is to determine whether Aspirin could affect the number and~     subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.~   "
34691|NCT02602925|"~     Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.~      Objective To investigate whether the dose of biologics can be reduced in patients with~     psoriasis with stable disease.~      Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with~     cost-effectiveness analysis.~      Study population: Patients with disease remission using normal dose of biologics.~      Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2)~     normal dose.~      Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary~     outcomes are: health-related quality of life (HRQoL), number and time to disease flares,~     costs, health status, anti-drug antibody formation and serious adverse events~   "
34692|NCT02602912|"~     The main purpose of the study is to assess the feasibility and clinical performance of~     impedance based tissue identification in various spine structures.~   "
34693|NCT02602899|"~     Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation~     to patients with refractory epilepsy.~   "
34694|NCT02602886|"~     The purpose of this research study is to evaluate whether Exposure and Response Prevention~     Therapy (ERP) can help adults with obsessive-compulsive disorder (OCD) in China following a~     training of professionals and ongoing consultation.~   "
34695|NCT02602873|"~     Tacrolimus is recommended to be the first line therapeutic medication within the several~     immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of~     its definite efficacy and low toxicity. But there are still some key problems which hinder~     the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual~     difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in~     practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure~     or toxicity. To find out the reasons of great pharmacokinetic difference between patients~     and find out the individual proper dosage before administration are important for the~     clinical using of tacrolimus.~      It is hot in research of tacrolimus in organ transplant field, such as the association~     between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant~     gene(MDR1) and concentration of tacrolimus. However, there is few study about~     pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.~      The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus~     and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to~     find out the exact dosage before administration, to provide reference to individual drug~     administration.~   "
34696|NCT02602860|"~     This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam)~     enter the human brain. Brain imaging will be used to measure how quickly the radioactive~     probe [11C]UCB-J exits the brain when Levetiracetam or Brivaracetam are given intravenously.~     This will be used to estimate how fast the antiepileptic drugs enter the brain.~   "
34697|NCT02602847|"~     The aim of this study is to validate in the context of liver transplantation, the interest~     of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on~     liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum~     liver through several groups of patients at transplantation (on graft and native liver~     explant) and after transplantation.~   "
34698|NCT02602834|"~     High intensity Interval training (HIT) has repeatedly been documented to have superior~     positive effects on oxygen uptake and general physical health compared to continuous~     moderate exercise in healthy individuals and patients with heart disease. Recently, the same~     effect has been shown in heart transplanted recipients. Which mechanisms that explains this~     difference is uncertain; the effect can be due to changes in the heart or changes in the~     peripheral tissue and muscles. To explore these mechanisms the investigators will in this~     study compare two different exercise modalities, and explore how different biomarkers change~     in blood, related to exercise.~   "
34699|NCT02602808|"~     It is important to identify patients with acute pancreatitis who are at risk for developing~     persistent organ failure early in the course of disease. The investigators evaluated whether~     peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could~     serve as a good marker for detection of acute pancreatitis with persistent organ failure at~     early phase.~   "
34700|NCT02602795|"~     Before starting treatment with XR-NTX, a medication that blocks the positive effects of~     opioids and helps people stay off opioids, individuals who are dependent on opioids first~     have to endure a difficult withdrawal process. This study aims to develop and test an~     intervention to help people who are opioid dependent successfully complete that transition;~     the investigators will also develop and test a comparison condition aimed at reducing HIV~     risk behavior.~   "
34701|NCT02602782|"~     The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring~     System and validate the accuracy of these measurements against existing gold standards, and~     to track and analyze changes in these physiologic data streams to identify clinical~     signatures that may enable earlier diagnosis and intervention of critical conditions.~   "
34702|NCT02602769|"~     Rapid onset Obesity, Hypoventilation, Hypothalamic dysfunction and Autonomic Dysregulation~     (ROHHAD) is a syndrome named in 2007. The hallmark of the syndrome is the rapid onset~     obesity and dysregulation of central ventilation. There is little information about the~     metabolic changes that lead to the rapid onset obesity in these children. The investigators~     would like to study the metabolic phenotype of these children to understand the disturbances~     in energy balance that lead to the rapid onset obesity.~   "
34703|NCT02602756|"~     Ocular melanomas have been treated for a long time by enucleation, with an unfavorable major~     impact on the patient's quality of life, social life, self-image, how they feel about others~     and about living with this disability. As a matter of fact, classical radiation therapy by~     photons is not accurate enough to deliver a sufficiently high dose to eradicate a melanoma~     without causing irreversible ocular brain complications since these tumors are  relatively~     radio resistant . The possibility of delivering high doses due to the precision of protons~     (Bragg peak) has allowed to overcome this limitation. The conservative uveal melanoma~     treatment has become a standard after the Collaborative Ocular Melanoma Study (COMS)~     indicating an equivalent rate of metastases and a non-impaired survival rate with a~     conservative treatment when compared to immediate enucleation. The quality of life benefits~     due to a conservative treatment has been demonstrated. Protontherapy dose has been defined~     in an empirical manner, it is probably excessive even if it applies to radio-resistant~     tumors. In France, radiotherapy by protons for choroidal melanomas delivers a dose of 60 Gy~     cobalt equivalent (that is 52 measured Gy, or  Physical dose) in 4 fractions and 4 days.~      Referential treatment of ocular melanomas (other than conjunctiva) indicates proton-therapy~     for T1, T2, T3 < 40% of ocular volume, and T4 only if extra scleral extension ≤ 2mm.~     However, there is an enucleation indication for T3 > 40% of ocular volume and T4.~      Our purpose is to override this relative contraindication, choroidal melanoma volume ≥ 40%~     of ocular volume. As a matter of fact, the investigators observe an increasing demand from~     ophthalmologists and patients for not performing primary enucleation. Also, during the last~     five years treatment of complications have improved and a less  hard  hypo fractionation~     (6.5 Gy per fraction) has equivalent local control results as for  hard  fractionation (13~     Gy per fraction).~   "
34704|NCT02602743|"~     Ketamine and propofol have been used most frequently agents and remifentanil is used with~     increasing frequency in recent years. Investigators will compare ketamine-propofol and~     ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in~     pediatric colonoscopy patients. Our study is a prospective, randomized comparison of~     ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during~     elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the~     study after ethics committee approval and written informed consent from the parents.~     Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be~     excluded from the study. Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be~     administered for induction in 1 minute.Then 0,1 µg/kg/h remifentanyl infusion will be~     started.~      Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and~     then 1 mg/kg/h propofol infusion will be started. In case of movement, crying, heart rate~     and systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of~     remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in~     group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.~      The anesthesiologist will continue monitoring after completion of colonoscopy until recovery~     of full consciousness. A Steward recovery score of 7 will be defined as the end of the~     recovery time.~   "
34705|NCT02602730|"~     This project developed and evaluated an Internet-based interactive program with digital~     coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers~     and (2) general-population smokers (i.e., men and non-pregnant women). Program content was~     based on the U.S. Department of Health and Human Services Clinical Practice Guidelines,~     Treating Tobacco Use and Dependence: 2008 Update (Fiore et al., 2008) and input from~     project consultants.~   "
34717|NCT02602574|"~     Post endoscopic pancreatitis (PEP) has different initial immunologic response to primary~     injury compared to acute pancreatitis of other etiology (non-PEP AP).~      The purpose of this study is to compare initial immunologic response, 24 h after primary~     injury, in patients with PEP and patients with acute pancreatitis of other etiology.~   "
34718|NCT02602561|"~     The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL~     injury occurs participation in physical activity is compromised. Reconstructive surgery is~     often necessary to repair the damage which is then followed by a regimen of physical therapy~     in order to regain full activity. Nutritional intervention after the surgery could help the~     patient maintain muscle mass during recovery, thus allowing for a quicker return to normal~     activity.~   "
34719|NCT02602548|"~     This study will describe the time point at which a positive culture from a patient who has~     undergone shoulder surgery should be treated as an infection versus a false positive result~     that should be disregarded. Intraoperative biopsies will be taken and cultured from 50~     subjects who have undergone an open surgical procedure and 50 from subjects undergoing an~     arthroscopic procedure.~   "
34706|NCT02602717|"~     Cytological examination of punctured lymph nodes is the gold standard for confirming~     metastatic lymph node spread of differentiated thyroid cancers. In order to increase the~     diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels~     of the aspirate could be included. Although this technique has been well proven, many~     uncertainties remain, especially with regards to a pathological cut-off value and its~     clinical utility when the thyroid is still intact. This uncertainty is mainly due to~     discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology,~     and their final histopathological analyses.~      To eliminate this uncertainty, cyto-punction will be performed intra-operatively after~     localizing and isolating the target lymph nodes for assessment of cytology and Tg values.~     The thyroid gland might be present or absent (already operated) depending on the case.~     Finally, the cyto-punctured lymph nodes will be excised for complete histopathological~     analysis. In order to determine whether the Tg values are appropriate in cases where the~     thyroid is intact, a control group has been included (First operation for thyroid cancer or~     benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and~     resection in patients for whom it is not indicated, only lymph nodes found along the~     incision path for neuromonitoring of the recurrent laryngeal nerve (performed~     systematically) will be analysed and excised.~   "
34707|NCT02602704|"~     -  The purpose of this study is to study the effectiveness of bazedoxifene in preventing~          loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures~          in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.~        -  This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At~          study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D~          (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene~          (20 mg/day) or none.~   "
34708|NCT02602691|"~     Transplant rejection is one of the most important complications of heart transplantation and~     requires a specific monitoring, including regular and invasive endomyocardial biopsies.~      The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States.~     In France, the reimbursement rates by the Health Insurance for the corresponding stays vary~     from 682 to 25 865 euros, according to the finding of a rejection and its severity.~      AlloMap® is a non-invasive blood test that can identify patients with low probability of~     moderate to severe acute cell transplant rejection. The non-inferiority of the use of the~     AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of~     acute cellular rejection in a randomized study conducted in the United States. Following~     this study, the ISHLT (International Society of Heart and Lung Transplantation) made~     recommendations advocating its use for these patients between 6 months and 5 years after~     heart transplantation. This new test could be an alternative to systematic biopsies usually~     performed to patients whose allograft function is stable, but it is very expensive since the~     analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared~     with the current patient care. By replacing biopsies performed systematically, the test~     should reduce the costs of full and day hospitalizations for the realization of biopsies but~     also the costs associated with their possible complications. In addition, it can be expected~     that its use provides a benefit to the patient in terms of quality of life. Indeed, the~     achievement of a biopsy may cause significant stress and anxiety for the patient, due to~     discomfort, pain and potential complications that may be severe.~      To this day, no medico-economic assessment has been conducted to prove the interest of the~     use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose~     of the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for~     monitoring heart transplant patients in the context of usual care and in accordance with~     international recommendations. AlloMap® will be used and compared to the current~     surveillance strategy by endomyocardial biopsies from 6 months to 36 months after heart~     transplantation. The investigators hypothesize that the use of this test for the diagnosis~     of acute cellular transplant rejection would avoid the costs of a large number of biopsies,~     while increasing the quality of life of patients related to their health.~   "
34709|NCT02602678|"~     Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway~     inflammation increases the respiratory system resistances and dynamic hyperinflation. This~     leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease~     patients as in neonates, prone position (PP) improves lung function and decreases the end~     expiratory lung volume. The investigators hypothesized that in infants with severe~     bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi)~     and the work of breathing (WOB). The investigator designed a prospective randomized~     crossover study with 16 infants younger than six months who need ventilatory support by~     nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work~     of breathing (product time pressure) and PEEPi will be estimated using an esophageal~     pressure probe in prone and supine position.~   "
34710|NCT02602665|"~     This is a single center, randomized, controlled trial in which tunneled central line~     catheters will be placed in two distinct, select positions. The catheter tip position will~     then be followed up prospectively after placement to determine whether there is any~     malpositioning of the tip and if one placement is better than the other.~   "
34711|NCT02602652|"~     The objective of this study is to measured the Geometric mean titer (GMT) of Japanese~     Encephalitis neutralizing antibody and proportion of seroprotection among the children who~     received a booster dose of JE-CV after the first dose of SA14-14-2 vaccine.~   "
34712|NCT02602639|"~     Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity~     (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs~     (100%) when compared to the general population. It is important to identify the modes and~     intensities of exercise most likely to generate a reduction in these inactivity-related~     diseases in this population.~      Therefore, the main purpose of this pilot research project is to implement and test a form~     of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical~     stimulation).~   "
34713|NCT02602626|"~     The purpose of this study is to determine if women would find it acceptable to receive the~     HPV vaccine postpartum at the pediatrician's office at the time of their child's two-month~     well- child visit when offered during the third trimester of pregnancy.~   "
34714|NCT02602613|"~     A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and~     its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted~     in a minimally invasive trans-catheter method.~   "
34715|NCT02602600|"~     The aim of the present study is to evaluate the effect of treatment with Liraglutide on the~     coronary microvasculature and angina symptoms, in overweight patients with microvascular~     dysfunction and angina pectoris but no coronary artery stenosis.~   "
34716|NCT02602587|"~     Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is~     down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is~     accumulated in cancerous conditions and virtually absent of normal tissues. This study will~     try to determine modulations of these oxysterols and protein involved in their metabolism~     between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for~     evaluation of these markers as companion biomarkers for Dendrogenin A treatment.~   "
34720|NCT02602535|"~     The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery~     Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic~     pain to prescription opioid misuse and addiction. The investigators plan to conduct a full~     scale clinical trial to determine whether MORE (relative to a support group control~     condition) can reduce symptoms of chronic pain and opioid misuse among patients who are~     receiving pain management in primary care via long-term opioid analgesic therapy.~   "
34721|NCT02602522|"~     This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen~     (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief~     of primary dysmenorrhea.~   "
34722|NCT02602509|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis~     (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in~     healthy volunteers following administration of the study drugs alone and in combination.~   "
34723|NCT02602496|"~     This study evaluates the impact of increased intake of fruits and vegetables and whole~     grains on markers of inflammation and gut microbial composition. The treatment groups are 3~     servings of whole grain per day; 5 servings of fruits and vegetables per day; a combined 3~     servings of whole grain per day and 5 servings of fruits and vegetables per day; and a~     control (3 servings of refined grains per day provided).~   "
34724|NCT02602483|"~     The objetive of this study is to explore the efficacy and safety of a triple combination of~     ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients~   "
34725|NCT02602470|"~     To survey patients with rosacea about their rosacea treatment preferences as well as to~     assess potential drivers of rosacea treatment satisfaction.~   "
34726|NCT02602457|"~     Atrial fibrillation is the most common heart rhythm disorder. The management of atrial~     fibrillation is of great importance. Despite the presence of exercise intolerance, weight~     gain, and an associated decline in overall health and well-being in patients living with~     atrial fibrillation, recommended standard care does not currently include the prescription~     of exercise to address these significant health issues. Exercise training is a recognized~     form of treatment of persons with heart disease. An exercise program such as high-intensity~     interval training when compared to moderate-intensity continuous exercise training may~     provide a stronger training stimulus for exercise and clinical outcomes; may be more~     efficient and motivating; and, may help to improve adherence to exercise training in~     persistent or permanent atrial fibrillation patients. This has been shown in patients with~     coronary artery disease and heart failure.~      The primary objectives of this prospective study are to examine the impact of high-intensity~     interval training compared to moderate-intensity continuous exercise training in adults with~     persistent or permanent atrial fibrillation on exercise capacity and quality of life.~   "
34727|NCT02602444|"~     The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics~     (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation~     myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding~     comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse.~     Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although~     it is not known whether PK and PD features of ticagrelor are uniform in these patients.~   "
34728|NCT02602431|"~     Third molars extraction is a surgery frequently performed in dentistry. It is generally~     associated to a great postoperative distress rendered by pain, swelling and trismus, caused~     by surgical trauma inflammation. Several methods have been proposed to prevent these~     complications and to increase tissue repair quality. The use of low level laser therapy~     (LLLT) has been reported in dentistry since 1970. A large number of studies have reported~     the benefits of LLLT without collateral damage, positive effect as an anti-inflammatory~     agent and benefits in accelerating wound repair. However, some clinical applications~     strategies have been contradictories in everyday practice with results not always~     equivalent.~      Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous~     in their effects in controlling postoperative edema, trismus, pain and wound repair in third~     molar surgery.~   "
34729|NCT02602418|"~     Despite potent combination antiretroviral therapy, cognitive (memory and concentration)~     problems continue to occur in up to 50% of HIV-infected individuals, especially in older~     infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no~     effective treatments are available to these individuals with cognitive problems,~     conservative estimates indicate that the cost of care for these patients could double in the~     next two decades. To address this urgent problem, this study will use a comprehensive~     approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a~     novel computer-based training program would improve the brain function, especially working~     memory and attention, in HIV-infected and infected individuals.~   "
34730|NCT02602405|"~     In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain~     permanent functional impairment, 1.200 receive disability pension, and approximately 2.500~     die because of their injuries. Mortality is the most common variable measuring trauma~     outcome. However, measuring only trauma mortality may be looking merely at the tip of the~     iceberg. For every trauma death, there are ten-folds suffering long term functional~     impairment. Mortality is therefore a too crude variable to describe the impact of injuries -~     both for the individual trauma patient and for society as a whole. There is a need for~     variables describing long-term outcomes on a functional level. The aim of this study is to~     use the rate of return to work and education as an alternative outcome measure. The ability~     of returning to work after injury is a central indicator of individual functional outcome,~     combining both physical and mental skills in performing complex and compound tasks. Previous~     studies on return to work after injury are limited by a combination of short follow-up~     times, the use of patient reported outcomes and having mainly been focusing on only severely~     injured patients (ISS > 15). This a population-based study including all patients in working~     age (16 - 65 years) received by a trauma team in any of the eight hospitals within the~     region of Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already~     collected trauma registry data will be linked with national register data on sickness and~     disability benefits, employment and education.~   "
34731|NCT02602392|"~     The potential benefits of this research to public health include improved understanding of~     cultural factors in pediatric asthma self-management, improved self-management skills for~     children, and better asthma management skills for their parents. This could result in eased~     suffering and improved quality of life for millions of children and their families, and also~     reduce the economic burden borne by society in the forms of medical expenditures and lost~     productivity.~   "
34732|NCT02602379|"~     Contrary to immobility and, to a lesser extent, to the hypnosis/unconsciousness~     component of general anaesthesia, the monitoring of analgesia remains largely elusive,~     evaluated mainly through poorly sensitive and potentially undesirable changes in patients'~     vital signs. This has led the industry to pursue the development of various devices and~     indices based on other physiological parameters such as heart rate variability (HRV),~     electroencephalogram (EEG), skin conductance, to name only a few. To the best of the~     knowledge, none of these parameters on its own has shown sufficient capacity in detecting~     different degrees of pain/analgesia balance to gain wide clinical use.~      The purpose of this prospective observational study is to evaluate the response of a~     single-parameter index (the Analgesia Nociception Index [ANI]) and a multi-parameter index~     (the Nociception Level [NoL] Index) when patients under combined general~     anaesthesia/epidural anaesthesia for laparotomies are subjected to a standardized painful~     stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at~     different doses of remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min;~     0,1 mcg/kg/min; 0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia~     provided gradually increased, it is expected to characterize the response of these two~     indices to different levels of nociception/anti-nociception balance.~   "
34733|NCT02602366|"~     The purpose of The Quatro Study is to assess the acceptability, preferences, user experience~     and effect on sexual behavior of four different vaginal microbicide or multi-purpose~     technology (MPT) delivery forms, using placebo products in 18-30 year old African women:~     rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also~     examines adherence to the dosage forms through objective markers, developed for each dosage~     form prior to the commencement of the study.~   "
34734|NCT02602353|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain~     patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle~     Soreness (DOMS).~   "
34735|NCT02602340|"~     This project aims to identify brain and behavioral characteristics of individuals~     experiencing symptoms of depression that will predict the effectiveness of Behavioral~     Activation Therapy. Brain imaging aspects of the study will use functional magnetic~     resonance imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will~     include self-report questionnaires, computer-based and observational tasks, and interviews.~     Assessments will focus on how individuals process positive information (such as reward) and~     negative information (such as distressing images), as well as how people make decisions.~     These assessments will be conducted across 2-3 in-person sessions prior to beginning the~     treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A~     blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will~     consist of 10, 90-minute weekly therapy sessions conducted in small groups.~   "
34736|NCT02602327|"~     This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients)~     designed to evaluate safety of the combination of Tas-102 and radioembolization using~     Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~   "
34737|NCT02602314|"~     The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline~     therapy vs IM followed by switch to NIL in the case of absence of optimal response as~     defined by the ELN criteria.~   "
34738|NCT02602301|"~     Objective: To evaluate the relationship between intravenous (IV) infusion of oxytocin using~     either saline 0.9% or glucose 5% & neonatal Bilirubin & sodium level.~      Study Design: A randomized case - controlled study. Setting: The Obstetrics and Gynecology~     casuality department of Kasr El Aini hospital (Cairo University - Egypt)~   "
34739|NCT02602288|"~     The purpose of this randomized controlled trial is to develop and test the efficacy of a~     multilevel, multimodal intervention designed to reduce children's exposure to secondhand~     tobacco smoke (primary outcome) and promote smoking cessation in mothers (secondary~     outcome). Low-income mothers who smoke and their children will be enrolled from the~     supplemental nutrition program, Women, Infants and Children (WIC) clinics. All mothers~     visiting WIC clinics will receive a clinic-level intervention, which consists of nutrition~     counselors following an ask, advise, and refer protocol to identify children exposed to~     secondhand tobacco smoke, advise mothers who smoke about the harms of such exposure and the~     benefits of reducing exposure, and referring mothers to the trial. Screened eligible mothers~     will be consented and randomized to an attention control condition focused on nutrition~     (CTL) or to an experimental (EXP) multimodal behavioral intervention that integrates~     telebased counseling to promote reduction of child secondhand smoke exposure (SHSE) and~     maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement~     therapy use. The investigators will test the primary hypothesis that relative to children in~     the CTL condition, those in the EXP condition will have lower exposure SHSE as measured by~     mothers' reports and child cotinine levels. The investigators will also test the secondary~     hypothesis that relative to mothers in the CTL condition, those in the EXP condition will~     have higher bioverified 7-day point prevalence quit rates. In addition, the study will: (a)~     evaluate if specific psychosocial and behavioral factors-- social support, urge coping~     skills, self-efficacy, and SHSe protective behaviors--mediate the effects of the EXP~     intervention on outcomes and (b) explore whether other residential smokers, level of~     nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dosage, and~     pregnancy status predict outcomes and moderate treatment effects.~   "
34740|NCT02602275|"~     The purpose of this study is to explore the effect of Neurexan® on the brain response when~     participants undergo an emotional stressful condition in verum compared to placebo.~   "
34741|NCT02602262|"~     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant~     from an HIV+ deceased donor will be followed to determine the safety and efficacy of this~     practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected~     donors will also be followed.~   "
34742|NCT02602249|"~     In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human~     gastric cancer are going to be investigated.~   "
34743|NCT02602236|"~     The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.~   "
34744|NCT02602223|"~     The purpose of this study is to examine if a biologically active commercially available~     amnion chorion membrane (ACM) is as effective as the commercially available inert dense~     polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it~     provides the added benefit of reducing post-operative discomfort after dental surgery~   "
34745|NCT02602210|"~     The main goal of the study is to investigate the clinical relevance, efficacy and safety of~     treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with~     low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to~     decrease mortality.~   "
34746|NCT02602197|"~     The investigators conducted a prospective, randomized, double blind study to compare the~     effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first~     24 hours postoperative period in adult patient undergoing septoplasty.~   "
34747|NCT02602184|"~     This clinical study will be a prospective, placebo-controlled, double-blind, randomized and~     centrally evaluated intra-individual comparative study to assess the safety and efficacy of~     AR/101 concomitantly administered with Standard of Care (SoC) in accelerating re~     epithelialization of split thickness wounds compared with placebo and concomitantly with~     SoC, in the pannus of volunteers undergoing elective abdominoplasty.~   "
34748|NCT02602171|"~     The present study has the evaluation of a test to measure the localization performance goal~     . It is about the perception of danger audio signals in everyday listening environments~     nearby which are reproduced in controlled laboratory conditions. In addition, a~     dereverberation algorithm regarding speech intelligibility and localization ability is~     evaluated . The research hypothesis is that the dereverberation of the audio signals can~     improve speech intelligibility for both normal hearing and hearing-impaired persons. In~     addition, the binaural dereverberation algorithm should not affect the localization ability~     in everyday situations.~   "
34749|NCT02602158|"~     13C breath tests represent an attractive alternative in the measurement of gastric emptying~     (GE). Therefore these tests have been used in a variety of clinical settings such as in the~     assessment of gastroparesis, delayed GE in diabetic patients or in the assessment of GE with~     fat containing enteral formulas in critically ill patients.~      The investigators have previously demonstrated that the 13C sodium octanoate breath test~     (OBT) is an inappropriate measurement method for the GE of fat. The OBT appears to be~     affected by 1) post gastric processing of the OCC marker and 2) its interaction with the~     physical form and concentration of the fat present in the stomach and duodenum.~      The13C trioctanoate breath test (TriOBT) represents an attractive alternative to the OBT.~     Compared to OCC which is a medium chain fatty acid the 13C trioctanoate (TriOCC) is a~     triglyceride. TriOCC has similar physio chemical properties as the nutritional lipid e.g.~     rapeseed oil.~      This study aims to assess the efficacy of the TriOBT as a GE measurement method of fat in an~     acid stable lipid emulsion (LE1). The breath test results from the TriOBT will be compared~     with the OBT and further validated against gastric fat volume emptying data observed from~     MRI. The interim analysis will determine whether the study will proceed to stage 2 which~     will assess the efficacy of the TriOBT in an acid unstable lipid emulsion (LE4).~   "
34750|NCT02602145|"~     Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the~     legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of~     the heart, but carries the highest rate of reconstruction failure. The underlying reasons~     for these poor results are not completely clear, but the main arterial segment within the~     leg, the femoropopliteal artery, appears to be significantly different from other peripheral~     arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that~     comprise the femoropopliteal artery segment, undergo large deformations during flexion of~     the limb. In our NIH application we propose to accurately measure these deformations using~     human cadavers and build mathematical models of human femoropopliteal arteries repaired with~     several frequently used PAD stents. These mathematical models would be able to assess the~     mechanical stress in the stented SFA and PA associated with limb flexion and predict disease~     recurrence for arteries with different patient and lesion characteristics. Results of model~     predictions will be validated in patients with PAD stents who have received these stents as~     part of their standard of care.~   "
34751|NCT02602132|"~     The study will be conducted at University Hospital Alcorcón Foundation, belonging to the~     public network of hospitals of Madrid Health Service.~      The aim of this study is to evaluate the effects of clamping the urethral catheter prior to~     removal and determine which of the two options (clamping or free drainage) is the most~     recommended for removal of bladder catheterization in adults.~      The interest of this study is given by the importance of proper handling of catheterization~     in the health of patients admitted to a hospital and are subjected to this technique.~     Increase its interest the need for implementation of evidence-based care, and limited~     scientific literature on the subject.~      The study population will be patients undergoing short-term urethral catheterization at the~     Internal Medicine Service in the University Hospital Alcorcón Foundation.~      The methodology of the study is experimental, randomized clinical trial without drug type.~     Interventions (prior clamped and free drainage) will be assigned in a randomized manner.~      Interventions and data collection of patients who met the inclusion criteria to join the~     study will be conducted during 2016 and the first quarter of 2017. It is planned to present~     results at the end of 2017.~      Keywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER,~     CLAMPING, REMOVAL, ACUTE URINARY RETENTION.~   "
34752|NCT02602119|"~     The primary end-point of the study is to determine the sensitivity of OTL in identifying~     lung nodules when excited by an imaging probe. Investigators intend to enroll 50 lung cancer~     patients in this study. The study is focusing on patients presenting with suspected~     malignancies of the lung and pleura who are considered to be good surgical candidates.~   "
34753|NCT02602106|"~     Aquatic activities is one of the most attractive physical exercise during pregnancy,~     especially during the third trimester.~   "
34754|NCT02602093|"~     Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus~     pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000~     to 75,000 people. Open microdiscectomy is the standard surgical technique.~      In recent years, several surgical techniques have been developed including, percutaneous~     transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The~     Netherlands, evidence of its effects is lacking, leading to a heated debate. The current~     position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support~     its use; therefore, PTED is not financially covered. The consequence is, patients are forced~     to pay the costs of treatment themselves. This study is expected to provide the necessary~     data to answer the question regarding effects and costs of PTED vs. open microdiscectomy,~     and help resolve the current debate.~   "
34755|NCT02602080|"~     Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and~     cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the~     focus on postoperative nausea, but published evidence is not based on standardized criteria~     for assessment. Therefore, the results for postoperative nausea are very diverse, especially~     reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When~     peripheral nerve blocks have been applied for postoperative pain control, they significantly~     reduce postoperative pain, opioid consumption and side effects; patients receiving general~     anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients~     receiving GA alone. This study is a pilot study looking at the incidence and intensity of~     nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under~     nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The~     results of this study will help power a future randomized controlled trial, comparing the~     incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway~     (LMA) versus spinal anesthesia.~   "
34756|NCT02602067|"~     Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal~     antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was~     studied on a commercial tissue array slides each carrying malignant breast, colorectal,~     lung, ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type~     showed positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is~     exploring the use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.~   "
34757|NCT02602054|"~     The decision to treat patent ductus arteriosus in preterm infants, varies from a~     conservative, medical or immediate surgical treatment; although, at present, there is some~     controversy about this decision. This study aims to determine the efficacy and safety of~     surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.~   "
34758|NCT02602041|"~     The investigators will perform a pilot study to gain insight into attitudes, barriers and~     facilitators for health behavior change in cancer patients and their partners. Results of~     this pilot will be used to design suitable questionnaires to investigate health behavior~     change in a larger cohort of patients and their partners. It will also direct future~     interventions to adequately target patients and, potentially, their partners to improve~     their lifestyle following a cancer diagnosis.~   "
34759|NCT02602028|"~     It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in~     pediatric patients with FMF compared to twice daily dosage schema.~      In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric~     patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and~     did not receive any treatment, were included. Patients were randomly assigned using block~     randomization method to receive treatment with once or twice daily doses. Clinical and~     laboratory characteristics and medication side effects were recorded and compared between~     groups. The study complied with Good Clinical Practice and the Consolidated Standards for~     Reporting of Trials (CONSORT) statement.~   "
34760|NCT02602002|"~     This was a single centre, randomised, double blind, placebo controlled, two-way cross-over~     design study to assess the feasibility of pain PD tests and to determine the variability and~     effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy~     volunteers.~   "
34761|NCT02601989|"~     The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin~     resistance, including glucose metabolism and subclinical inflammation, after a 6-week~     administration of tadalafil in T2D patients. The primary objective is to study the effect of~     tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic~     clamp.~      This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five~     T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for~     six weeks and after a wash-out period of eight weeks intake of placebo for another six~     weeks, or vice versa. At the end of each 6 week treatment period a glucose clamp,~     subcutaneous needle biopsies as well as muscle and subcutaneous microdialysis will be~     performed. Endothelial function tests and arginin stimulation of insulin secretion tests~     will be performed after 3 weeks in each treatment arm.~   "
34762|NCT02601976|"~     Hepatitis C is a global problem, prevalent in developed as well as in the developing~     countries. New treatment regimens using PegInterferon in combination with ribavirin has led~     to improved sustained viral response rates for some genotypes. A single arm, open labeled,~     multicentre trial was conducted to evaluate the response rate and safety of PegInterferon~     alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic~     hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for~     genotype 1 patients and SVR was determined at 24 weeks after completion of treatment.~     Quality of life at baseline and at follow-up visits were determined using SF-36.~   "
34763|NCT02601963|"~     The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it~     helps people with moderate-to-severe papulopustular rosacea.~      The investigational product is FMX-103 minocycline foam. Two concentrations of the~     investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be~     applied once daily to the face for the 12-week treatment duration of the study.~      Approximately 210 patients will participate in this study.~   "
34773|NCT02601820|"~     The PROP UP research study is funded by The Patient Centered Outcomes Research Institute~     (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate~     all-oral treatment regimens for HCV regarding several patient-reported outcomes (PROs) such~     as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket~     costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare~     PROs of different treatment regimens, treatment durations, and patient subgroups.~     Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with~     HCV infection who are prescribed a regimen containing Harvoni®, Viekera Pak®, Zepatier®,~     DAC/SOF or SOF/VEL for chronic HCV will be recruited and approximately 1600 patients who are~     approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys~     will be evaluated before, during and after HCV treatment.~      PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient~     engagement group and a patient advocacy organization.~   "
34764|NCT02601950|"~     This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800~     mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine~     eligibility for the study will be performed within 21 days of the first planned dose of~     tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor~     type:~        -  Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small~          cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant~          rhaboid tumor of the ovary [MRTO]~        -  Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement~        -  Cohort 3: Other INI1 negative tumors or any solid tumor with an EZH2 gain of function~          (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor~          (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other~          INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma)~          any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma~          and melanoma~        -  Cohort 4: Renal medullary carcinoma (RMC)~        -  Cohort 5: Epithelioid sarcoma (ES)~      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity~     or withdrawal of consent, or termination of the study. Response assessment will be evaluated~     after 8 weeks of treatment and then every 8 weeks thereafter while on study.~   "
34765|NCT02601937|"~     This is a Phase I, open-label, dose escalation and dose expansion study with a BID oral dose~     of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned~     first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be~     evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.~      The study has two parts: Dose Escalation and Dose Expansion.~      Dose escalation for subjects with the following relapsed/refractory malignancies:~        -  Rhabdoid tumors:~        -  Atypical teratoid rhabdoid tumor (ATRT)~        -  Malignant rhabdoid tumor (MRT)~        -  Rhabdoid tumor of kidney (RTK)~        -  Selected tumors with rhabdoid features~        -  INI1-negative tumors:~        -  Epithelioid sarcoma~        -  Epithelioid malignant peripheral nerve sheath tumor~        -  Extraskeletal myxoid chondrosarcoma~        -  Myoepithelial carcinoma~        -  Renal medullary carcinoma~        -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor~          approval)~        -  Synovial Sarcoma with a SS18-SSX rearrangement~      Dose Expansion at the MTD or the RP2D, for subjects with rhabdoid tumors~     (MRT/ATRT/RTK/selected tumors with rhabdoid features).~   "
34766|NCT02601924|"~     Eighty patients with inclusion criteria will participate in this studyEach patient will~     receive an injection in one of the following groups according to the random number table:~        1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)~        2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB~        3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)~        4. Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be~          asked to record the amount of pain they felt during needle penetration and injection~          using VAS form.Data will be analyzed using ANOVA and t-test.~   "
34767|NCT02601911|"~     The aim of this study is effect of premedication on success of inferior alveolar nerve block~     injection. Sixty healthy adult volunteers including criteria, are participating. The~     patients will be divided into 3 groups and will be randomly given one of premedications~     including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo,~     45 minutes before applying the injection. All patients will receive standard Inferior~     Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to~     cold and electric pulp tests would be excluded from the study. Endodontic access preparation~     will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during~     treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be~     considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity~     preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and~     Kruskal-wallis tests.~   "
34768|NCT02601898|"~     The aim of this study was to compare the therapeutic efficacy of lipoic acid versus~     progesterone by vaginal administration on subchorionic hematoma resorption in women at the~     first trimester of pregnancy with threatened miscarriage.~   "
34769|NCT02601885|"~     This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and~     immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS)~     receiving maintenance glatiramer acetate (Copaxone).~   "
34770|NCT02601859|"~     The project is designed to generate critical information to design and justify a robust~     trial on lithium prevention of the onset of Alzheimer's disease (AD). Lithium exerts and~     inhibitory effect on Glycogen synthase kinase 3 (GSK-3) a brain biomarker of~     neuroprotection. The study consists of 3 phases:~        1. Phase 1 investigates rats to establish a reliable method to measure brain biomarker~          activity levels from blood biomarker activity.~        2. Phase 2 will determine whether the GSK3 enzyme activity is significantly different in~          subjects with MCI compared to normal individuals.~        3. Phase 3 investigates patients with MCI taking lithium to establish the minimum lithium~          dose required to inhibit the activity of GSK-3.~   "
34771|NCT02601846|"~     A multicentre multinational prospective management outcome study has recently proven the~     safety of a diagnostic strategy combining clinical probability assessment with an~     age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for~     ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE.~     Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers,~     as it allowed ruling out PE without further investigation in a significantly higher~     proportion of patients than when using standard cut-off, particularly so in patients 75~     years or older.~      The objective of the present study is to confirm in a prospective cohort of real life~     patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients~     presenting to the emergency department with suspected PE.~   "
34772|NCT02601833|"~     The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF)~     for treatment of cavities in baby teeth. The investigators will compare the effectiveness of~     stopping the cavity, cost of the treatments and the opinions of the families and the dental~     providers.~   "
34807|NCT02601378|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent in~     patients with metastatic uveal melanoma.~   "
34774|NCT02601807|"~     The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is~     taped over the affected area and stimulation at a high frequency is reported to alleviate~     pain with no sensation. However there is no class 1 evidence for this on back pain. By~     randomising patients between application of an active device or a dummy device and~     assessment of disability and pain scores at two weeks, the efficacy or otherwise can be~     established. Low back pain is a major health problem and if effective this has major~     economic implications as the device is cheap and safe.~   "
34775|NCT02601794|"~     The investigators are conducting a web-based study to explore the use of a mindfulness app~     to improve quality of life among women with breast cancer.~      Eligible participants will be asked to provide informed consent to participate and submit a~     data authorization form to obtain information from the app at the end of the project.~      This 12-week project will randomly assign participants to one of two groups:~      Group 1 (AMT) will receive the mindfulness app right away; Group 2 (WC) will receive the~     mindfulness app at the end of 12 weeks.~      All participants will receive a welcome email with group designation. Participants assigned~     to Group 1 (AMT) will also receive app download instructions and pass code. Group 1 will be~     asked to complete the app's first 10-minute mindfulness exercise, at minimum.~      Participants assigned to Group 2 (WC) will be notified that they will receive app download~     instructions and pass code at the end of 12 weeks.~      Regardless of group assignment, all participants will be asked to complete web-based survey~     assessments 4 different times throughout the study (baseline, week 5, week 9, 12-week follow~     up). The surveys will be related to quality of life, mindfulness, mobile technology, health~     literacy, and chronic pain.~      To encourage participation, a member of the study team will send out weekly check-in emails.~      Once all data has been collected, app developers will provide the investigators with app~     data for each participant, including times accessed, length of time using app. This~     information will help the investigators observe which app characteristics are most useful,~     as well as the optimal amount of time needed to obtain benefit from the app.~      The investigators goals are to understand how using the mindfulness app compares to not~     using the mindfulness app. The investigators will also observe whether the app contributes~     to participants' quality of life. The investigators also want to understand more about how~     women use health apps overall. This information may inform issues related to delivery of~     app-based health interventions among women with breast cancer.~   "
34776|NCT02601781|"~     BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter~     registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary~     intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and~     exclusion criteria.~      This registry has the objective to assess the immediate (peri-procedural and 30 days), mid~     (6 months and 1 year) and long-term (3 and 5 years) results following BVS implantation using~     a pre-specified implantation strategy during PPCI in STEMI subjects.~   "
34777|NCT02601768|"~     The aim of this study is to determine whether three-dimensional tranesophageal~     echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be~     as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing~     during transcatheter closure of the defect.~   "
34778|NCT02601755|"~     Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain~     that is not treated properly can reduce quality of life. Programs to help AYA learn to live~     with and manage pain are very important. Our team is developing a smartphone application~     (app) and website for AYA with chronic pain. The app will help AYA to track pain, sleep,~     mood, activities, and exercise and help AYA set and achieve goals. The website will give~     information about pain and how to manage it independently. We will build the program and~     make sure it is easy to use and understand. We will also test if the program can be put into~     practice as planned and if AYA using the program feel less pain, have less limitations, and~     a better quality of life.~   "
34779|NCT02601742|"~     Acute diarrhea is the third cause of infant mortality in the world causing 15% of all deaths~     in children under 5 years and is responsible for nearly 1.4 million deaths in developing~     countries. It is considered a self-limiting disease and to this problem the recommendation~     of the World Health Organization (WHO) is the administration of zinc with low osmolarity~     oral dehydration salts for a period of 10-14 days which reduces the severity of the episode.~      In Mexico COFEPRIS believes the zinc salt as a food supplement and not a drug and the above~     problem is presented in terms of prescribing and access of this salt to the general~     population. In Mexico the investigators have the provision and accessibility of low~     osmolarity oral dehydration salts supplemented with adequate doses of zinc, which is~     inexpensive for the general population and offering a solution in terms of supply and~     management.~      The purpose of the study involves the evaluation Pedialyte diarrhea in the treatment of~     acute diarrhea in children under 5 years. The investigator sconsider the use of Pedialyte~     diarrhea eases their access to the population in general and it is low cost compared with~     the zinc salt that is sold only in specialized pharmacies under strict medical prescription~     Objective: Compare the duration of symptoms of acute diarrhea in the treatment with low~     osmolarity oral rehydration salts (Pedialyte) vs treatment of low osmolarity oral~     rehydration supplemented with zinc (Pedialyte diarrhea) Study Desing: Double blind,~     randomized, controlled.~   "
34780|NCT02601729|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated~     destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical~     mass of β-cells the need for exogenous insulin therapy emerges. Several methods exist to~     administer insulin. An alternative way to administer insulin is by means of continuous~     subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of~     self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is~     essential in the management of diabetes, but this is very limited and also lacks information~     about rising or falling trends in the actual glycaemia. A solution for this is the use of a~     Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures~     glycaemia 24 hours a day, provides information about glucose direction and rate of change~     during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a~     selected group of type 1 diabetic patients by means of a so-called CGM convention. The~     main objective of the study is to evaluate the impact of real time continuous glucose~     monitoring reimbursement on real-life clinical care parameters of type 1 diabetic patients~     in Belgium.~   "
34781|NCT02601716|"~     This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of~     PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve~     adult subjects.~   "
34782|NCT02601703|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study~     to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark~     Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1%~     (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).~   "
34808|NCT02601365|"~     This study will investigate the safety and efficacy of the administration of inhaled GM-CSF~     to children with respiratory virus-associated pneumonia.~   "
34783|NCT02601690|"~     This is a research study intending to look at the response of a specific type of allergy~     cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs~     (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a~     non-interventional study in which no investigational product will be administered to any~     subject.~   "
34784|NCT02601677|"~     Nucleus accumbens/anterior limb of internal capsule play important roles in the process of~     treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus~     accumbens/anterior limb of internal capsule will inhibit its activity and thus to~     effectively prevent the disorder.~   "
34785|NCT02601664|"~     Design: Single center, single-blind randomized controlled trial of patients with high risk~     native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block~     chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will~     be randomized to either a combined intervention or conventional PCI. Cardiac biomarker~     measurements will be performed before PCI and 18-24 hours later.~      Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and~     glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and~     complete coverage of the lipid core plaque, if technically feasible.~      Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to~     compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI~     troponin distribution in the two study groups.~      The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of~     normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI.~     (3) Lower incidence of major adverse cardiac events, defined as the composite of death,~     acute coronary syndrome, or coronary revascularization) during 30-day follow-up.~   "
34786|NCT02601651|"~     The primary objectives of this study is to access the effect of perioperative lidocaine~     infusion on total morphine requirement during the first 24 h postoperatively in patients who~     underwent laparoscopic totally extraperitoneal inguinal hernioplasty.~   "
34787|NCT02601638|"~     Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission.~     Many of these readmissions are related to stomal care, and it is thought that the~     readmissions could be prevented with better patient and caregiver education. The~     investigators are studying the effect of a comprehensive perioperative education program on~     30-day unplanned readmission for patients undergoing total laryngectomy.~      The comprehensive perioperative education program will include the following additional~     interventions:~      -Preoperative visit with the speech pathologist for explanation of laryngectomy physiology,~     stomal education, and alaryngeal voice rehabilitation. Participants will be expected to~     undergo this intervention and to attend it with their laryngectomy coach (a family member~     or friend to accompany the patient through the education process), but failure to meet with~     the speech pathologist will not exclude a patient from the study.~        -  Preoperative education class with a designated ENT laryngectomy nurse for patient and~          caregiver. The hands-on class introduces the patient and laryngectomy coach to the~          basics of stomal care. Participants and their laryngectomy coach will be expected to~          attend the preoperative education class~        -  Printed laryngectomy journey guide given to patients at time of study enrollment for~          patient/caregiver. This journey guide details the preoperative, in-hospital, and~          post-discharge course and is provided as a reference throughout their journey.~        -  Formalized, nursing administered practical evaluation of minimal competency of~          laryngectomy care for patient and caregiver/laryngectomy coach.~      This study will follow patients prospectively from the time of study commencement and then~     assess changes in patient knowledge before and after the education intervention. It will~     also compare rate of stomal complications and readmission rates to institutional historical~     averages to assess improvement in quality care.~   "
34788|NCT02601625|"~     This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the~     Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy~     subjects~   "
34789|NCT02601612|"~     The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2~     vaccine in RSV-seropositive children and RSV-seronegative infants and children.~   "
34790|NCT02601599|"~     Background: Smoking counselling during hospitalisation with post-discharge follow-up~     increases quitting. However, provision of cessation care for hospitalised patients is~     suboptimal. Students are potentially an untapped resource for providing cessation advice,~     but no studies have investigated this.~      Aim: To determine if medical students can encourage motivation to stop smoking (MTSS;~     primary outcome) in hospitalised smokers .~      Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital~     (www.hse.ie/eng/services/list/3/hospitals/Connolly/).~      Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students~     will receive standardised motivational interviewing training in the provision of cessation~     advice. Each student will be randomly assigned to counsel ~1-3 smokers each, including an~     individual in-hospital, face-to-face session and post-discharge phone counselling. Training~     and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care'~     (n~90), or intervention (n~90, student-delivered motivational interviewing). A researcher~     will enable recruitment and follow-up, and conduct a qualitative evaluation of programme~     participants.~   "
34791|NCT02601586|"~     This study will be conducted in three parallel groups receiving oxycodone, levodopa or~     placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian~     treatment. As this study focuses on chronic central neuropathic pain caused by PD, the~     effects of study treatments will be evaluated after a 10-week treatment period~   "
34792|NCT02601573|"~     This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose~     combination (FDC) of elbasvir (50 mg)/grazoprevir (100 mg) (EBR/GZR) and 400 mg of~     sofosbuvir (SOF), with and without ribavirin (RBV), in treatment-naïve (TN) and~     treatment-experienced (TE) subjects with chronic Hepatitis C Virus (HCV) Genotype 3 (GT3)~     infection with compensated cirrhosis.~   "
34793|NCT02601560|"~     A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety,~     Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI6012 in Subjects~     with Stable Coronary Artery Disease~   "
34794|NCT02601547|"~     Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a~     promising approach for detecting brain lesions in dementia, among which Alzheimer's disease~     has been the most widely studied.~   "
34795|NCT02601534|"~     The goal of the study is to evaluate the effectiveness of a family-focused and interactive~     intervention for reducing the sedentary behavior and increasing physical activity of the~     participants. The intervention is to use the concept of zero time, zero money, and zero~     equipment (3 Zero exercise), which aims to get sedentary people to start exercising. The~     intervention aims to encourage positive and sustainable health actions among participants~     and their family members.~   "
34809|NCT02601352|"~     The study mainly focuse on examining the subjects living in traffic polluted area with~     elevated blood pressure and assessing the popuation health risk using disease and risk~     assessment models.~   "
34796|NCT02601521|"~     Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners~     HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial~     will compare two interventions designed to help smokers stop using tobacco: (1) External~     Coaching Program (Standard Care) and (2) Internal Coaching Program, a chronic disease~     management strategy for treating tobacco use and dependence.~   "
34797|NCT02601508|"~     This study is designed to evaluate the surgeon's satisfaction with either deep or moderate~     neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery~     profiles in the recovery room and the ward.The explorative objective of this study is to~     evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of~     postoperative complications.~   "
34798|NCT02601495|"~     In this study the investigators will seek to improve their understanding of how positive and~     negative valence systems, cognition, and arousal/interoception are inter-related in~     disorders of trauma, mood, substance use, and eating behavior for women involved in a court~     diversion program in Tulsa, Oklahoma (Women in Recovery). The investigators will recruit 100~     individuals and use a wide range of assessment tools, neuroimaging measures, blood and~     microbiome collections and behavioral tasks to complete the baseline and follow-up study~     visits. Upon completion, the investigators aim to have robust and reliable dimensional~     measures that quantify these systems and a set of assessments that should be recommended as~     a clinical tool to enhance outcome prediction for the clinician and assist in determining~     who will likely benefit from the diversion program, and to inform future revision or~     augmentation of the program to increase treatment effectiveness.~   "
34799|NCT02601482|"~     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and~     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The~     time spend with high-intensity (fast) walking is considered to be responsible for the~     improvements seen, whereas the time spend with low-intensity (slow) walking is considered~     less important.~      This study will assess if IW with maintained fast walking time duration but reduced total~     time duration (i.e. reduced slow walking time duration) is equally effective as IW with a~     normal time duration.~      Subjects with type 2 diabetes will be included in a crossover, controlled study, where each~     subject will undergo three trials. Trials will be identical except the following~     interventions:~        1. Sixty minutes of rest (CON)~        2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3~          minutes of slow walking; IW-60)~        3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of~          fast and 1.5 minutes of slow walking; IW-45).~      After the interventions subjects will undergo a standardized mixed meal tolerance test with~     assessment of glycemic control.~   "
34800|NCT02601469|"~     An open label, safety study to assess the potential for adrenal suppression following~     maximal use treatment with DSXS administered twice daily for 28 days in patients with~     moderate to severe plaque psoriasis.~   "
34801|NCT02601456|"~     The purpose of this study is to determine the effect of prolonged effort in long distance~     running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee~     running with running specific prosthesis.~   "
34802|NCT02601443|"~     The incidence of multiple gestations has increased over the past years, mostly because of~     increased use of assisted reproductive technologies. Triplet pregnancies are at increased~     risk of preterm birth (PTB), which is the primary reason for their increased morbidity and~     mortality compared to singletons. Multiple gestations, including triplets, account for about~     3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of~     very low birth weight infants, and nearly 20% of infant mortality.~      A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good~     predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a~     short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and~     perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the~     contrary, the effect of cerclage in multiple gesttations has been insufficiently studied,~     with meta-analysis data showing a possible harm from cerclage compared to controls.~      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in~     unselected triplet gestations.~      We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU~     CL <30 mm)~   "
34803|NCT02601430|"~     The purpose of this study is to determine if an MRI technique called Blood Oxygen Level~     Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment~     with standard endovascular therapy in patients with chronic lower limb ischemia.~   "
34804|NCT02601417|"~     Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and~     appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo~     guideline, but the clinical significance is yet unproven. And its results might indicate~     less information of the true pathogen regarding normal flora. Previous study conducted at~     our institute found drug-resistant pathogens identified in bile culture had no impact on the~     outcome. So the investigators are conducting a multicenter randomized controlled trial~     comparing groups which considers both blood and bile culture as control and which considers~     only blood culture as trial group in order to prove bile culture provides no additional~     helpful clinical information.~   "
34805|NCT02601404|"~     Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients~     with coronary artery disease. However, a continued risk of clinical events even several~     years after the procedure is reported. Stent platform or polymer-associated inflammation may~     play a role.~      Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation,~     which may result in the more favorable very long-term clinical outcomes compared with~     metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets~     were comparable to DESs.~      BRS, however, is limited by the disadvantageous mechanical characteristics such as thick~     strut and the risk of fracture by overdilation. There is concern that BRS is less optimal~     for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or~     diffuse long lesions. Real world registry is needed to test the feasibility and safety of~     BRS in these complex lesion subsets.~   "
34806|NCT02601391|"~     The purpose of this study is to determine how effective the STEPPS-HI group is at improving~     emotional regulation skills in those with identified difficulties in this area within~     forensic inpatient services. In addition, to explore whether there is increased~     acceptability of the adapted STEPPS group (STEPPS-HI) for this client group.~   "
34810|NCT02601339|"~     This study is to use advanced near-infrared spectroscopy (NIRS) technology for monitoring~     cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) in newborns that developed~     germinal matrix-intraventricular hemorrhage (GM-IVH) and post-hemorrhagic hydrocephalus~     (PHH) at the bedside. We hypothesize that baseline cerebral metabolic dysfunction is a~     better biomarker for GM-IVH and PHH severity and response to PHH treatment.~      This is a multi-center study at Massachusetts General Hospital (MGH), Brigham and Women's~     Hospital (BWH) and Boston Children's Hospital (BCH). The Partners Institutional review board~     (IRB) has approved the protocol to conduct study at BWH and MGH. The IRB protocol at BCH is~     at the final stage of approval.~      Dr. Pei-Yi Lin receives the funding from National Institute of Health (NIH) to support the~     study and is the overall principal Investigator (PI) overseeing the study.~   "
34811|NCT02601326|"~     A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's~     procedure in treatment of complete rectal prolapse to ass both efficacy and complications~   "
34812|NCT02601313|"~     Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of~     KTE-C19 in subjects with Relapsed/Refractory MCL~   "
34813|NCT02601300|"~     This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral~     GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and~     a Mayo endoscopic subscore≥ 2.~      Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS)~     or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for~     duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α~     blockers will be limited to approximately 15 subjects. The number of subjects with extensive~     colitis is targeted to comprise approximately 50% of the entire study population.~   "
34814|NCT02601287|"~     This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of~     Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or~     Overactive Bladder.~   "
34815|NCT02601274|"~     A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced~     solid tumors~   "
34816|NCT02601261|"~     Investigating the influence of Internet use to the level of state anxiety in hospitalized~     women with pathological pregnancy.~      A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at~     first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again~     to 35.8% at third trimester (art. 29).According to the World Health Organization, mental~     health disorders are the leading cause of disease burden in woman from 15 to 44 years~     (art.6). A Swedish study indicated that the incidence of moderate or extreme symptoms of~     anxiety and depression of pregnant woman during the first trimester is 15,6% (art. 3).~   "
34817|NCT02601248|"~     First-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary~     anti-tumor activity of Theliatinib .~   "
34818|NCT02601235|"~     Prospective, randomized, open label, parallel , multicenter clinical study, controlled by~     active comparator ( 0.05 % Oxymetazoline Hydrochloride ) .~      The investigators hypothesis is that pediatric Naridrin® nasal solution is superior to 0.05~     % Oxymetazoline Hydrochloride in improving nasal congestion.~      Participants aged 10-17 years with a clinical diagnosis of nasal congestion of allergic or~     inflammatory origin in at least one of the nostrils due to rhinitis or rhinopharyngitis will~     be included in the trial.~   "
34819|NCT02601222|"~     The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule~     in treating chronic eczema.~   "
34820|NCT02601209|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating~     patients with sarcoma that is too large to be removed (locally advanced) or has spread to~     other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride both work to~     stop the growth of tumor cells by blocking enzymes that are needed for cell growth. It is~     not yet known whether sapanisertib may be more effective than standard treatment with~     pazopanib hydrochloride in treating patients with locally advanced or metastatic sarcoma.~   "
34821|NCT02601196|"~     Hypothesis:~      After reviewing the relevant medical data the investigators assume that treating a woman~     with intramural fibroid not distorting the uterine cavity or mostly intramural with less~     than 50% submucosal component with Ulipristal Acetate (UPA) for a 13 weeks course would~     reduce the fibroid size and improve her chance for conceiving by IVF treatment.~      Materials & Methods:~      Study design: A proof of concept prospective not randomized study. The patients: About 20~     women treated in the fertility and IVF unit after at least one IVF failure, with mostly~     intramural (IM) fibroid [class 2-5 by FIGO (International Federation of Gynecology and~     Obstetrics) classification system] in the size of >4 cm confirmed by Transvaginal ultrasound~     (TVUS) and diagnostic hysteroscopy.~      After US examination and diagnostic hysteroscopy to ascertain suitability for this study,~     the investigators will offer a course of 13 weeks treatment with UPA 5 mg per day.~      One month after cessation of treatment the investigators will perform another TVUS~     examination & diagnostic hysteroscopy plus endometrial biopsy in order to assess the~     endometrial & uterine status and will conduct an additional IVF cycle, using the same~     stimulation protocol undertaken during the immediate cycle previous to the UPA treatment~     course.~   "
34832|NCT02601053|"~     For centuries the term blood curling has been used to describe extreme frightening~     situations. However, the origin of this ancient theory has never been studied and it remains~     unknown if fear induces the coagulation system.The objective was to explore the effects of~     acute fear on the coagulation system while sitting still. In a crossover study design~     healthy subjects will be exposed to a horrifying e.g. scary movie followed by a dull e.g.~     flat movie which is shown at least 1 week after the first movie on the same day of the week~     at the same time of the day. Participants will be recruited among students from the Leiden~     University Medical Center. Blood will be drawn from the cubital vein 10 minutes before the~     first movie, directly after the first movie. The same will be done 10 minutes before and~     directly after the second movie. Blood is drawn by using a needle puncture.~      Individual markers of coagulation activity will be determined from the blood samples. Pulse~     rates will be measured and an anxiety/fear score will be collected from each student for~     both movies.~   "
34822|NCT02601183|"~     The cerebrovascular diseases can be approximately divided as two types, namely ischemic and~     hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for~     acute ischemic stroke patients. But it's difficult to diagnose the ischemic stroke with the~     hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the~     hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. And time~     cost by CT or MRI examination is likely to responsible for missing the narrow time window~     and poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid,~     portable and inexpensive diagnosis method which can sensitively distinguish the stroke type~     before CT or MRI examination would be very helpful in treating the ischemic stroke patients.~      Because of the blockage in the cerebral supply artery, the heat from circulatory system will~     sharply decrease in infracted hemisphere among the ischemic stroke patients. The reduced~     brain temperature influenced the temperature on the ipsilateral forehead according to the~     data of our animal and preliminary clinical trial. In contrast, the temperature of the~     ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our~     preliminary experiment. The difference of the temperature tendency on the ipsilateral~     forehead has a great chance to be an early physical mark.~      In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be~     recruited. In the process of recruitment, the patients with acute stroke attack in no more~     than 4.5 hours will be collected the temperature at the five point without head coverage,~     including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and~     contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic~     group according to the later CT or MRI results in the hospital. The accuracy and sensibility~     of early brain temperature in distinguishing stroke type would be tested in comparison with~     the diagnosis of imaging examination.~   "
34823|NCT02601170|"~     Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of~     bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage~     damage and bony destruction. Currently available treatment of hemophilic arthropathy, such~     as analgesics, NSAIDs, and hyaluronic acid (HA), are predominantly directed toward the~     symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage~     degeneration.~      Platelet-Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural~     concentrate of autologous growth factors from the blood. This method is now being~     increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon~     repairment and osteoarthritis. To the best of our knowledge, no study applies PRP for~     arthropathy of knee joint in hemophilia patients. The aim of the study is to investigate the~     efficacy, safety and duration of benefit of single PRP injection versus five weekly~     intra-articular injections of HA in patients with hemophilic arthropathy of knee.~   "
34824|NCT02601157|"~     We had little experience in coronary intervention with recently introduced newer~     drug-eluting stent (DES) platforms, despite great anticipation, and optimal duration of dual~     antiplatelet therapy (DAPT) for these stent systems still needs to be established.~      With a 2x2 factorial design for patients of stable angina or silent ischemia, the~     investigators formulate a head-to-head randomized comparison between sirolimus-eluting~     Orsiro stent with biodegradable polymer and polymer-free stent platform with the same~     antiproliferative agent, Coroflex ISAR stent system. At the same time, clopidogrel treatment~     is added to aspirin during the 3-months period after the stenting, and this abbreviated~     duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1~     randomized stratification. 1-year target lesion failure (TLF) as a composite of cardiac~     death, target vessel related myocardial infarction and clinically driven target lesion~     revascularization will be identified as a primary efficacy outcome. And in addition to TLF,~     definite or probable stent thrombosis and major bleeding events will also be counted as a~     composite outcome of net adverse clinical events (NACEs) to comprehensively adjudicate the~     efficacy and safety outcomes according to the difference of DAPT duration.~      With this trial, you will be able to get clear insight on the behavior of newer DES~     platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated~     in the selected patients, and it might be helpful to those who need it.~   "
34825|NCT02601144|"~     This is the first study on the effect of the variable frequency stimulation (VFS) on~     Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded~     poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This~     study would have significant clinical implications in the management of Freezing of gait~     (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize~     that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).~   "
34826|NCT02601131|"~     The purpose of this study is to identify how the platelet count, complement system and~     endothelial markers are affected over time, after platelet transfusion in 4 different~     hematological patient groups.~   "
34827|NCT02601118|"~     This study was undertaken to investigate the effectiveness of the Micro Expression Training~     Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal~     communication skills of medical students.~   "
34828|NCT02601105|"~     The purpose of this study is to clinically evaluate the efficacy, safety as well as patient~     satisfaction in the use of topical Centella asiatica (CA) on the cosmetic appearance of~     stretch marks.~   "
34829|NCT02601092|"~     Several retrospective studies have shown same efficiency in regard to weight loss, with a~     lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to~     Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial~     is to compare the two procedures in respect of excess weight loss, complications, operation~     time, length of stay and the metabolic impact on the hormonal brain-gut-axis.~   "
34830|NCT02601079|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this~     study are as follows:~        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability~          to establish the correct diagnosis based on collected biopsies of tumors in the upper~          GI tract.~        -  Based on the quality of the collected tissue samples we want to evaluate which~          instrument generates the most useful material for genetic studies of the tumor.~   "
34831|NCT02601066|"~     This research study includes patients ages 1 to 25 years old with Lamin A/C related muscular~     dystrophy (LMNA-MD). The goal of this study is to evaluate how the heart is affected in~     children and teens with LMNA-MD. The evaluation includes an echocardiogram, an~     electrocardiogram, an electrophysiological study and the implantation of a subcutaneous ECG~     holter monitor.~   "
34833|NCT02601040|"~     The main purpose of this study was to evaluate the safety and immunogenicity of~     Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese~     people.~   "
34834|NCT02601027|"~     The purpose of this trial is to determine if using abdominal nerve blocks when patient~     undergo breast reconstruction can significantly decrease use of pain medications after~     reconstructive surgery.~   "
34835|NCT02601014|"~     This phase II trial studies how well nivolumab and ipilimumab work in treating patients with~     hormone-resistant prostate cancer that has spread to other places in the body and express~     androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be~     resistant to hormone therapy and some chemotherapy in patients with prostate cancer.~     Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key~     biomarkers or proteins that help tumor cells to escape the immune system surveillance and~     this may help the immune system to kill tumor cells that express AR-V7.~   "
34836|NCT02601001|"~     The purpose of this study is to evaluate the PK, safety and tolerability of omecamtiv~     mecarbil in healthy volunteers.~   "
34837|NCT02600988|"~     The purpose of this study is to determine whether vitamin D is effective in the prevention~     of graft-versus-host-disease after completion of allogeneic transplant.~   "
34838|NCT02600975|"~     This is a clinical trial in which healthy volunteers will be administered an experimental~     malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.~      All vaccinations will be administered intramuscularly. Each volunteer will receive three~     vaccinations in total.~      There are two different vaccine schedules:~      Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21~     50µg with AS01B on days 0, 28, and 56.~      The study will assess the safety of the vaccine, and the immune responses to the~     vaccination. Immune responses are measured by tests on blood samples.~      Healthy adult volunteers will be recruited in Oxford and Southampton, England.~   "
34839|NCT02600962|"~     The aim of the study is to investigate the impact of an initial non-specific / non-cardiac~     diagnosis on mortality among patients hospitalised with acute myocardial infarction.~   "
34840|NCT02600949|"~     The goal of this clinical research study is to learn if it is possible to make a vaccine for~     advanced pancreatic or colorectal cancer. The safety of this vaccine will also be studied.~      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue~     samples) and blood to help create a vaccine designed specifically for you based on what the~     study doctor and research staff can learn about the type of mutated proteins (a type of~     genetic change) in the tumor.~   "
34841|NCT02600936|"~     The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have~     undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of~     this study is to monitor and evaluate the long-term outcomes of venous stents placed to~     treat venous outflow obstruction. Outcome variables that will be assessed are: patency rate,~     reintervention rate, occurrence of any complications, clinical improvement, and quality of~     life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in~     the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein,~     brachiocephalic vein, or superior vena cava. While vein stent placement procedures are~     currently being performed in the United States, using stents which are commercially~     available and FDA-approved for use in arterial interventions, at this time there are no~     stents that are FDA-approved for use in veins. The placement of stents in veins holds~     tremendous promise as a treatment for venous outflow obstruction, but review of current~     literature has showed a paucity of published data on the long-term outcomes of this~     treatment.~      The study is composed of two arms, a retrospective arm and a prospective arm. Any patient~     over the age of 18 who has undergone or is scheduled to undergo a vein stent placement~     procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are~     being requested for the retrospective arm for patients who have undergone a vein stent~     placement procedure from January 1st 2012 to date of study onset, as it is not possible to~     contact all patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up~     with a study physician). This study is only interested in the collection and analysis of~     data; the clinical care and outcomes of research subjects will not be affected by their~     participation in this study.~      An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by~     Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary~     stents being used as treatment for venous outflow obstruction at Mount Sinai is the~     Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate~     sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller~     self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents~     other than Wallstents™ being used and the impracticality (if not impossibility) of obtaining~     IDEs for all other stents, the investigators believe it is appropriate to exclude usage of~     these stents from the study data. To confirm, the purpose of this study is to monitor and~     evaluate long-term outcomes of the venous stents/the vein stent placement procedure, not~     specifically the Wallstent™ itself.~   "
34842|NCT02600923|"~     The purpose of this study is to provide access to palbociclib in Mexico and in selected~     Latin American countries before it becomes commercially available to patients with HR~     positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.~   "
34843|NCT02600910|"~     Over 300,000 people in the United States have spinal cord injuries and many use manual~     wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and~     pain that greatly affect quality of life and level of independence. Understanding when~     shoulder disease starts in manual wheelchair users and which daily activities contribute to~     the disease will provide necessary evidence for effective primary prevention methods to~     inhibit the development of further disability. Our central hypothesis is that the~     development of shoulder disease in manual wheelchair users will be strongly associated with~     the cumulative exposure to elevated shoulder postures combined with high upper body loading.~   "
34844|NCT02600897|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment~     with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or~     refractory FL or DLBCL. Participants with FL who achieve complete response (CR), partial~     response (PR), or stable disease (SD) at the end of induction therapy will receive~     post-induction treatment with obinutuzumab and lenalidomide, and participants with DLBCL who~     achieve CR or PR at the end of induction will also be eligible for post-induction treatment.~   "
34845|NCT02600884|"~     The purpose of this research study is to evaluate a brief parent-based adolescent sexual~     health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an~     established intervention called Families Talking Together (FTT) and will enhance FTT by~     adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether~     FTT will help parents increase sexual health communication, delay adolescent sexual debut,~     and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be~     delivered by student nurses.~   "
34846|NCT02600871|"~     The purpose of this study is to determine if the use Provodine as an antiseptic and hand~     wash once daily for at least 7 days will have better healing, better health outcomes, fewer~     treatment failures and fewer infections themselves and among their household contacts than~     those who do not use Provodine.~   "
34847|NCT02600858|"~     The study determines whether standard medical care (dopamine) affects learning and retention~     of an upper limb feeding task in people with Parkinson's disease (PD) and whether training~     on the feeding task generalises to performance on an untrained upper limb buttoning task.~     Half the participants will train on the feeding task after they have taken their first dose~     of dopamine for the day (i.e. on medication state), while the other half will train on the~     same feeding task before taking their first daily dose of dopamine (i.e. off medication~     state).~   "
34849|NCT02600832|"~     The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham~     training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female~     veterans entering treatment for AUD at the VA Medical Center at San Francisco, California,~     between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test,~     and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving~     will be administered at baseline and Week-4. Immediately following screening, patients will~     be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each)~     taking place over three weeks. Following the 3 weeks of training, patients will complete a~     Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and~     craving and a Week-12 follow-up assessing drinking behavior.~   "
34850|NCT02600819|"~     This study will evaluate the safety and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) in HIV-1 infected adults with end stage renal disease (ESRD) on chronic~     hemodialysis (HD) at Week 48.~   "
34851|NCT02600806|"~     A clinical protocol was developed for the management of adult outpatients with~     community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients~     are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels~     measured with a rapid point-of-care method. When PCT levels are <0.5 ng/ml, azithromycin,~     500 mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is~     given orally for 7 days~   "
34852|NCT02600793|"~     Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics~     called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in~     adults patient shave shown ceftaroline fosamil to be effective against many bacteria that~     are resistant to other currently approved antibiotics. Some of these bacteria may be~     responsible for infections in the central nervous system.The main aim of this study is to~     gather information to determine how much of a single IV dose of ceftaroline fosamil will~     enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with~     infections can be better determined.~   "
34853|NCT02600780|"~     Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits~     antihyperuricemic activity by reducing the formation of uric acid. The investigators~     conducted an interventional, two-arm, randomized, open label pilot study on patients with~     serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or~     Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety~     of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.~   "
34854|NCT02600767|"~     This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of~     Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of~     P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine~     for three days, with doses according to the Brazilian guidelines for malaria control. The~     clinical and parasitological parameters will be monitored for a 28-day follow-up period to~     evaluate the efficacy of the combination therapy. A blood sample will be collected on filter~     paper on the first day and on the day of suspected failure to try to differentiate the~     parasite genotypes using techniques based on polymerase chain reactions. The results of this~     efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to~     evaluate the national policy for treatment of malaria caused by P. falciparum.~   "
34855|NCT02600754|"~     This study aims to find an effective and sustainable approach to reducing disparities in~     accessing mental health services for an underserved and growing population group of~     low-income, racially diverse, homebound older adults. It will compare two aging-service~     integrated, teledelivered depression treatments for these seniors. One model is short-term~     problem-solving therapy by licensed clinicians; the second model is self-care management~     support by trained lay advisors. The findings are expected to create a foundation of~     information for guiding the implementation of acceptable, effective, and sustainable~     depression care within widely available aging-service infrastructures.~   "
34856|NCT02600741|"~     The primary purpose of this study is to evaluate the overall effect of caregivers receiving~     a study-provided caregiver psycho-education and skills training program on the number of~     treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit,~     crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or~     suicide attempt) in patients under their care during a 12 month period.~   "
34857|NCT02600728|"~     Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute~     to progressive impairment in gait performance. The use of declarative memory cues in order~     to promote the engagement of attention and activation of the next movement in gait may~     minimize the consequences of lack of automatic control. The purpose of this study is to~     verify the long-term efficiency of a new strategy based on declarative memory cue to improve~     the gait performance and independence in daily life activities (DLA) in patients with PD.~   "
34858|NCT02600715|"~     The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)~     can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder~     for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial~     cystitis.~   "
34859|NCT02600702|"~     The purpose of this study is to compare the exercise protocol called Siriraj home base~     exercise program for OA knee to usual care and physical modalities for conservative~     treatment in patients with 1st OA knee.~   "
34860|NCT02600689|"~     Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention~     to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those~     individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any~     type of maintenance exercise therapy (phase 3). This is largely due to personal factors,~     such as access to transportation, weather, scheduling difficulties, and cost.~      Little is known about how to enhance physical activity among patients with IPF. In addition,~     no studies have investigated the long-term maintenance strategies of physical training in~     patients with IPF. Thus, the purpose of this study is to test the feasibility and~     effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized,~     blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and~     cognitive video gaming, with no active whole body movement involved — will be used to~     investigate the benefits of a home-based exergame program on improving pulmonary-related~     function and symptoms in patients with IPF.~   "
34862|NCT02600663|"~     Patients with acute back pain (<6 weeks) presenting at their general practitioner will be~     enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will~     fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening~     Tool. These two questionnaires categorize back pain patients into individuals at risk of~     chronic back pain and those not at risk. Furthermore, data concerning pain location,~     severity, duration and impairment will be collected. Study participants will receive~     standard care treatment prescribed by their general practitioner. Six months later, study~     participants will receive a questionnaire in order to collect data concerning their present~     pain situation. Patients with relevant impairment in their activities of daily living as a~     result of back pain will be categorized as individuals with chronic back pain.~     Categorization at six months will be compared with the categorization at presentation.~   "
34863|NCT02600650|"~     The purpose of this study is to determine whether a proprietary 'testosterone-boosting'~     supplement, when used as recommended by the manufacturer, results in an increase in~     testosterone levels as measured by a salivary free testosterone assay.~   "
34864|NCT02600637|"~     Summary: Thousands of Veterans suffer a stroke every year, and these individuals often~     suffer emotional and cognitive changes that negatively affect their quality of life as well~     as their ability to recover. In addition to traditional rehabilitation such as physical and~     occupational therapy, a number of alternative treatments are now being studied for their~     ability to enhance patients' recovery following stroke. One of these treatments,~     Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches~     individuals strategies such as breathing techniques, meditation, and movement therapy. The~     current pilot study proposes to teach MBSR to a group of Veterans with a history of stroke~     to determine whether this type of intervention is feasible, acceptable to patients, and~     shows preliminary evidence of beneficial effects on psychological and cognitive functioning.~     The investigators hope to find that MBSR is a useful, additional intervention that can~     improve Veterans' well-being and quality of life as they recover from stroke.~   "
34865|NCT02600624|"~     The purpose of this study is to examine the association between maternal alcohol use and~     newborn phosphatidylethanol (PEth) levels in their newborn.~   "
34866|NCT02600611|"~     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim~     compared to vancomycin for the treatment of skin and skin structure infections.~   "
34867|NCT02600598|"~     This is a Phase I, single-centre, open label, within-subject comparison trial to explore the~     biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in~     patients with actinic keratosis on the upper extremity. The treatment area for each patient~     will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including~     the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at~     least one AK lesion located in a non-treated area on the contralateral arm. All eligible~     subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study~     medication application will be (sub)investigator applied. A total of 30 patients will be~     enrolled into this study (n=15 in each of the two groups). Patients will be divided into two~     groups with different biopsy schedules.~   "
34868|NCT02600585|"~     The primary objective of this study is to retrospectively characterize the safety of Flublok~     in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent~     inactivated influenza vaccines (IIVs), using a methodological approach designed to query the~     database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern~     California (KPNC), a large medical care organization (MCO).~   "
34869|NCT02600572|"~     Determine the changes in attention level due to isometric exercises and level three~     progression eccentric movements. The attention level will be measured using a mental speed~     test (how quickly a subject can process information and make decisions based upon that~     information). Another outcome measure will be the ability of the subject to maintain balance~   "
34870|NCT02600559|"~     This is an 8-week, multicenter, open-label study in which eligible subjects with a history~     of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is~     designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement~     with common concurrent surgeries and any middle ear effusion status.~   "
34871|NCT02600546|"~     Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total~     corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping~     in normal subjects and corneal patients.~   "
34872|NCT02600533|"~     This study will measure the effects of an office-based, clinical trial education video on~     clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no~     previous history of clinical trial participation. This study will also determine the~     feasibility of implementing an office-based video educational program.~   "
34873|NCT02600520|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical and radiographic efficacy of two local drug delivery~     systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in~     patients with chronic periodontitis as an adjunct to SRP.~   "
34874|NCT02600507|"~     The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or~     valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center~     study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive~     episode.~   "
34875|NCT02600494|"~     The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,~     parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I~     or Bipolar II disorder having a major depressive episode.~   "
34876|NCT02600481|"~     This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have~     different impacts on troponin T（TnT) level as well as pulmonary complications after~     prolonged robot-assisted surgeries in the Trendelenburg position.~   "
34877|NCT02600468|"~     The purpose of this study to collect information on the safety, especially serious~     infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous~     Infusion 250mg in patients with rheumatoid arthritis.~   "
34878|NCT02600455|"~     The purpose of this study to collect information on the safety, especially localized~     injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL~     in patients with rheumatoid arthritis.~   "
34879|NCT02600442|"~     A correlation between early changes in the tumor maximum standardized uptake value (SUVmax)~     on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological~     response after 6 to 8 cycles has been demonstrated in several independent small series of~     patients.~      Breast tumor proliferation status has previously been demonstrated to be a good predictive~     factor of response to chemotherapy. The best method for assessing proliferation status is~     unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay~     for comparing the proliferation status between tumors. However major variations in~     analytical procedure and interpretation limited its clinical value. Taking into account the~     prognosis and predictive value of proliferation gene as a common signature in breast~     cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved~     in proliferation has been developed by the investigators team and others. The evaluation of~     these parameters is quantitative and reliable and can be standardized for a clinical use.~      The main objective of the investigators study is to early predict pathological response to~     anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based~     on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of~     proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry~     and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of~     the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).~   "
34880|NCT02600429|"~     The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic~     Solution compared to placebo for the treatment of NK.~   "
34881|NCT02600416|"~     The aim of this study is to determine the effects of AV port reversal (AVPR) on~     recirculation, clearance, post-filter ionized calcium and subsequently citrate dosing.~   "
34882|NCT02600403|"~     The aim of this study was to evaluate structural and functional improvement following~     intraocular pressure (IOP) reductions in patients with glaucoma using Spectral Domain~     Optical Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked~     Potential (VEP).~   "
34883|NCT02600390|"~     SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.~   "
34884|NCT02600377|"~     Vegetarian and vegan diets have been shown to reduce chronic disease risk, including~     diabetes and cardiovascular disease, as well as several cardiometabolic risk factors.~     Whether vegetarian and/or vegan dietary patterns improve cardiometabolic risk factors in~     individuals with diabetes remains unclear. To address the uncertainties, the investigators~     propose to conduct a series of systematic reviews and meta-analyses of the totality of the~     evidence from randomized controlled trials to distinguish the effect of vegetarian and/or~     vegan diets on the prevention and management of diabetes. The findings generated by this~     proposed knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers~     and patients, stimulating industry innovation, and guiding future research design~   "
34885|NCT02600364|"~     The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation~     Device.~   "
34886|NCT02600351|"~     This study will evaluate the efficacy, safety and tolerability of ledipasvir/sofosbuvir~     (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in~     participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24~     weeks without RBV in participants with cirrhosis.~   "
34887|NCT02600338|"~     Legumes are generally recognized as healthy dietary components, and although beans and~     legumes are recommended in food guidelines in North America, guidelines vary in regards to~     how much and how often these foods should be consumed. Furthermore, although North American~     and European guidelines recommend dietary pulses for glycemic control, dietary pulses and~     other legumes are not specifically suggested for controlling blood pressure and maintaining~     heart health. To improve evidence-based guidance for legume recommendations, the~     investigators propose to conduct a systematic review of clinical studies to assess the~     effect of eating legumes in exchange for other foods on blood pressure in humans. The~     systematic review process allows the combining of the results from many small studies in~     order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The~     investigators will be able to explore whether eating legumes has different effects in~     different demographics, and whether or not the effect of legumes depends on how much/often~     they are eaten. The findings of this proposed knowledge synthesis will help improve the~     health of Canadians through informing recommendations for the general public, as well as~     those at risk of heart disease and diabetes.~   "
34888|NCT02600325|"~     New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure~     95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir~     (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA~     approved combination DAA therapy.~      It is likely that the synergistic effect of the host's immune response and antiviral therapy~     when given during the first 6 months of HCV infection makes antiviral therapy during acute~     HCV infection more effective. In this study the investigators would like to document that~     treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can~     ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss~     in efficacy.~      Study design and intervention:~      Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4~     patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily~     combination tablet).~      Study population:~      80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV~     treatment centers in the Netherlands and Belgium will be included.~      Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT~     study population (=genotype 1 and 4).~   "
34899|NCT02600169|"~     This study is a retrospective cohort study. A database will be created from the data~     available of all patients that have participate in the named patient program for~     pembrolizumab in the Netherlands. This database will be used for analysis of response~     markers and for an evaluation of adverse events.~   "
34900|NCT02600156|"~     The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided~     focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk~     native prostate cancer.~   "
34901|NCT02600143|"~     The aim of this trial is to identify biomarkers and genetic predisposition for the~     development of immune checkpoint related colitis.~   "
34889|NCT02600312|"~     The Oxiris® filter is a registered product for CRRT already safely used in routine care.~      In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and~     cytokines. Compared to conventional filters this may be advantageous in patients with severe~     sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has~     been demonstrated with clinical use.~      But there are so far little clinical data on the oXiris® filter on humans. The oXiris®~     filter will be investigated in a double blind randomized crossover setting against a~     traditional filter (ST150). Either filter will be used for 24 hours after which it will be~     changed to the opposite filter for another 24 hours.~      Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the~     start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10~     (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode~     and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory~     support and pathogen will be registered.~      Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired~     t-test on AUC values for each 24-hour period.~   "
34890|NCT02600299|"~     As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported~     outcomes and survivorship issues. In view of the numerous medication and psychosocial issues~     that are commonly faced by early-stage breast cancer survivors, it deems important to~     develop and conduct specific interventional programs to mitigate these problems. In the~     literature, it is well recognized that psychosocial interventions are effective to manage~     emotional distress and quality of life, with the evidence clearly clustered in studies on~     female patients with breast cancer. One meta-analysis suggested that psycho-oncologic~     interventions including individual psychotherapy, group psychotherapy, psychoeducation,~     relaxing training can produce positive effects on emotional distress, anxiety and~     depression, and health-related QOL.~      The investigators hypothesize that a significant reduction in anxiety, improvement of~     cognition and improvement of health-related quality of life among those who receive~     psycho-education, in comparison to those in the usual care. Hence, this randomized trial is~     designed to assess the effectiveness of a psycho-educational group (PEG) intervention on~     supportive care and survivorship issues, which include anxiety, depression, cognitive~     function, toxicities management of cancer- or treatment- related physical symptoms, and~     health-related quality of life in early-stage breast cancer patients.~   "
34891|NCT02600286|"~     The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited~     peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal~     dominant, associated with a duplication of the chromosome 17p11.2 region which leads to~     overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major~     component of peripheral myelin.~      In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A~     (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in~     the prognosis evolution of the disease. Furthermore, several studies have shown that the~     administration of progesterone increased the expression of PMP22 gene (measured in a skin~     biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22~     and improve symptoms in rat CMT1A.~      The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal~     acetate and (EllaOne®). Few side effects have been reported including a few cases of~     endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare~     cases of adrenal androgen and failure have been observed. However, EllaOne® has low~     antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The~     investigators therefore believe that it will be well tolerated in humans and will reduce the~     synthesis of PMP22 and the action of oxidative stress by improving disability of patients.~   "
34892|NCT02600273|"~     The purpose of this study is to assess initial reactions to alternative nicotine/tobacco~     products among smokers living with HIV.~   "
34893|NCT02600260|"~     Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of~     these patients. The application of a protocol for assessing the risk of VTE reduces~     mortality and morbidity of these phenomena.~   "
34894|NCT02600247|"~     This study aims to compare the effectiveness of duloxetine after total knee arthroplasty in~     Central sensitization patient. Central sensitization plays an important role in the chronic~     pain experienced by osteoarthritis patients.Elimination of the nociceptive input from the~     damaged joint by total joint arthroplasty was not always followed by a complete resolution~     of symptoms. Patients with high levels of preoperative pain and low pain thresholds had a~     higher risk of persistent pain after total knee arthroplasty (TKA), which has been~     interpreted as evidence of central sensitization. Thus, the presence of central~     sensitization before surgery in Osteoarthritis patients may be an important contributing~     factor to postoperative pain versus adequate analgesia. Preclinical models of central~     sensitization suggest that duloxetine is effective in the treatment of persistent pain.~     Investigators will compare the pain following TKA of central sensitization patients in~     duloxetine group (n=50) with those in non-duloxetine group (n=84). Investigators will~     classify the central sensitization patients by central sensitization inventory and divide~     the central sensitization patients in to 2 groups (duloxetine and non-duloxetine group)~     randomly. Investigators checks the visual assessment scale at preoperative, postoperative 1,~     2,6,12 weeks. All participants will receive postoperative pain control after TKA using the~     same pain control regimen except duloxetine.~   "
34895|NCT02600221|"~     To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with~     chronic airflow limitation in China.~   "
34896|NCT02600208|"~     This is a single arm pilot study for patients with hematologic malignancies with alternative~     donor sources receiving unrelated or partially matched related/Haploidentical mobilized~     peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus~     CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one~     year leukemia free survival.~   "
34897|NCT02600195|"~     This 4-year cluster randomized controlled trial aims to determine whether implementation of~     Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired~     infection in Chinese Neonatal Intensive Care Units (NICUs).~   "
34898|NCT02600182|"~     The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure~     (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients~     undergoing cardiac surgery at the University Hospital of Santa Maria.~   "
34903|NCT02600117|"~     Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop~     the same types of liver complications that patients in the active state of hepatitis B virus~     (HBV) infection experience. Treatment guidelines for patients in the active state of HBV~     infection indicate that HBsAg clearance is associated with definitive remission of the~     activity of chronic HBV & improved long-term outcome. Clinical data showed that HBsAg~     clearance is achievable, in a small population of patients on continuous treatment with~     potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible~     the same OAVs can have the same effect in patients with inactive CHB, but in a shorter~     treatment duration. The purpose of this study is to find out if TDF is effective in~     controlling HBV DNA & promoting seroconversion from HBsAg-positive to HBsAb-positive in~     patients with inactive CHB.~   "
34904|NCT02600104|"~     Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles~     Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5~     investigational sites.~   "
34905|NCT02600091|"~     Type 1 diabetes is a challenging condition to manage. Anxiety and depression are common~     among this group and are associated with poorer diabetes control. No trials have been~     conducted to ascertain the effectiveness of psychological interventions designed to~     alleviate significant levels of anxiety and/or depression and improve glycaemic control~     among those with Type 1 diabetes who have significant difficulties with their emotional~     wellbeing and diabetes control.~      The aim of this project is to establish if it is feasible to run a multi-site randomised~     controlled trial in Scotland exploring whether an 8-week mindfulness and self-management~     based intervention programme decreases anxiety and/or depression, and improves diabetes~     control. This feasibility study, based on the MRC framework for assessing feasibility and~     piloting methods, will assess the relative strengths and weaknesses of the intervention and~     study design, and pave the way for a larger and definitive trial.~   "
34906|NCT02600078|"~     With exposure to high altitude some individuals will develop acute mountain sickness (AMS).~     Current evaluation of AMS can make it difficult to rule out other possible conditions.~     Evaluation of ataxia, as measured by the performance of a coordinated task, can aide in the~     correct diagnosis of AMS. The investigators have developed novel finger-tapping tasks on a~     mobile device to assess both reaction time and accuracy. The proposed research will evaluate~     the utility of this tool in assessing human acclimatization to hypoxia.~   "
34907|NCT02600065|"~     Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases.~     Neurological decline is observed in these patients and tumor progression or radiotherapy~     side effects have been made responsible for this. However CMV encephalitis may also be a~     reason. Therefore the investigators aim to analyze the CMV status in patients during and~     after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies~     (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with~     changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the~     peripheral blood will be performed.~   "
34908|NCT02600052|"~     INTRODUCTION:~      Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as~     bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the~     overall PD patients, mostly there is associated respiratory disorders. The respiratory~     impairment may be due by postural changes, limiting the flexibility and expandability of the~     chest wall causing decreased lung volumes and flows. So the exercise Proprioceptive~     Neuromuscular Facilitation (PNF) is a tool designed to reduce the changes in respiratory~     function, the commitment of the respiratory muscles, and allows greater flexibility of the~     chest wall, reducing the rigidity of the rib cage. To evaluate the effects of respiratory~     pattern of Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary~     ventilation, compartmental volumes of diaphragmatic mobility and functional capacity in~     patients with Parkinson's disease.~      METHODS:~      The study is a clinical trial randomized, in which participants to be elected for the study~     should present diagnosis of PD, staging of disease between II and III according to Hoehn and~     Yahr. Initially, the participants will undergo the collection of data on medical history,~     assessment of pulmonary function by spirometry and respiratory muscle strength measured by~     the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental~     distribution of the volume of the chest wall by hemithorax by Plethysmography~     Optoelectronic; Quantify the mobility of the right diaphragm in total lung capacity for~     maneuver and during the current volume by ultrasonography. After the evaluation,~     participants will undergo intervention which will consist of three stages: first occur first~     session of the PNF later aerobic training for 30 minutes, ending with one PNF session.~   "
34909|NCT02600039|"~     Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory~     therapy is always recommended to the CF patient with pulmonary involvement and has~     differents techniques and devices, however, there is no consensus on the effectiveness of~     the techniques used, there is a need to determine the applicability of the therapeutic~     resources used. Therefore, the aim of the study is to determine the short-term effectiveness~     of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary,~     assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical~     trial randomized crossover. Volunteers will be included with FC with moderate to severe lung~     disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations~     in the last four weeks or during the study period; cor pulmonale; facial deformity that~     causes air leakage; facial trauma and recent face or esophagus surgery; chest pain;~     hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day);~     hemoptysis; hemodynamic instability and do not understand the use and command of the~     techniques used. The sample is selected by convenience from the database of individuals~     assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The~     research will be developed in three phases, divided into three days with an interval of at~     least 48 hours between phases. The first day will undergo initial assessment and in the days~     following the intervention by day, ELTGOL or Acapella, in a randomized order.~   "
34910|NCT02600026|"~     This study will use an in-car monitoring system supplemented with video feedback to reduce~     the number of unsafe driving behaviors. If successful, this technology will provide a means~     to enhance public safety on the roads that could be adopted immediately in this at-risk~     group of drivers. The intervention will also maximize the time for independent driving,~     improving the overall quality of life of these individuals.~   "
34911|NCT02600013|"~     The aim of this observational, non-controlled, non-profit study is to describe the responses~     to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete~     motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient~     intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the~     device are also assessed and described.~   "
34912|NCT02600000|"~     Heart failure (HF) is configured major problem for public health in the country. Affected~     individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of~     the sympathetic myocardial activity, among others. In relation to the treatment of patients~     with heart failure with symptoms mentioned above a great alternative is the implantation of~     cardiac rehabilitation programs, these programs can also be associated with other muscle~     training measures, among these there is inspiratory muscle training (IMT), as the weakness~     of these muscles is rather found in this population and this directly related to signs and~     symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with~     a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and~     maximal and submaximal functional capacity of patients with HF between 21-60 years.~     METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed~     in partnership with the Department of Physical Therapy, Federal University of Pernambuco~     (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on~     the Recife's main referral centers in caring for patients with heart failure. Patients will~     undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and~     digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac~     innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and~     quality of life. After the evaluation will be randomly allocated into two groups: The~     control group will perform cardiac rehabilitation associated with the Sham of IMT, and the~     experimental group cardiac rehabilitation associated with the IMT at 30% of maximal~     inspiratory pressure. The intervention will last three months for both groups and after this~     phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify~     the association between physical exercise associated with specific respiratory training in~     modulating the autonomic nervous system of patients with HF and what the relationship with~     reflected cardiorespiratory fitness in maximal and submaximal functional capacity.~   "
34913|NCT02599987|"~     Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion~     capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the~     respiratory system, and decreased respiratory muscle strength resulting from uremic~     myopathy. The inspiratory muscle training (IMT) appears as an instrument to improve the~     inspiratory muscle strength, with positive effects on functional capacity and quality of~     life of kidney patients, however, the effects of IMT were not addressed in the specific~     variables of the respiratory system and to date there are no studies on the use of daily~     training in this population. Objective: To evaluate the effectiveness of daily inspiratory~     muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and~     mobility of end-stage renal disease patients. Methods: A randomized controlled clinical~     trial to be developed in Cardiopulmonary Physical Therapy Laboratory of the Universidade~     Federal de Pernambuco (UFPE) during the period from November 2015 to December 2016. The~     sample is composed of 24 individuals aged 18 and 65, having CKD, to perform hemodialysis for~     at least twelve months and provide inspiratory muscle weakness. Patients will be divided~     into two groups, the training group will be IMT with POWER-breathe®, load of 50% of MIP,~     duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week~     for 8 weeks, since the sham group will be subjected to the same procedure (duration and~     frequency), but without load. Participants will be assessed before and after intervention~     through a global assessment form, questionnaire Kidney Disease Quality of Life Instrument~     Short Form - KDQOL-SF, diaphragmatic ultrasound, opto-electronic plethysmography,~     spirometry, manometer and six-minute walk test.~   "
34914|NCT02599974|"~     The two main objectives of this prospective study are:~        -  to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET~          (positron emission tomography) CT-scan (Computed tomography scan) provides useful~          information for the treatment of breast cancer (ASAINT 1),~        -  to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant~          therapy early, in M0-patients (ASAINT 2).~      The secondary objective is to better understand the interactions between the imaging~     parameters of FDG PET-CT-scan and biological and histological features of breast cancer .~      This is a non-interventional study. Two PET-CT-scans are performed, one before starting~     treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans~     are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital,~     in Paris, France. Oncologists provide clear information to the patients on the purpose of~     the examination. The examinations are performed in the nuclear medicine department at St.~     Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and~     biological tests, results of surgery and patient's follow-up are summarized in a~     de-identified file. This file has been declared to the National Commission on Informatics~     and Liberties (CNIL). The data in this file are established prospectively and secondary~     analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer~     and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant~     treatment early.~   "
34915|NCT02599961|"~     UX007G-CL202 is an open-label, single-arm, multi center extension study to assess the~     long-term safety and efficacy of UX007 in Glut 1 DS. The study will enroll up to 40~     pediatric, adolescent and adult Glut 1 DS subjects who have completed the UX007G-CL201 study~     or participated in qualified ISTs.~   "
34916|NCT02599948|"~     Assessment of nutritional practices in french intensive care units.~   "
34917|NCT02599935|"~     To assess the effect over the nutritional status in patients who are malnourished with~     chronic heart failure, of an educational intervention and the provision of nutritional~     supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12~     months~   "
34918|NCT02599922|"~     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of~     rAAV2tYF-PR1.7-hCNGB3 administered to one eye by subretinal injection in individuals with~     achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be~     safety and the secondary study endpoint will be efficacy.~   "
34940|NCT02599636|"~     Many factors before and after ICU stay determine the outcome of patients at ICU discharge,~     the type of illness, physical dependence and other sequelae can be a trigger for~     complications in hospital ward which can induce ICU readmission and worse outcome. The~     quality of medical assistance during all the hospitalisation should be guaranteed and many~     complications or fatal events could be avoidable.~      The objective of the present study is to demonstrate that collaboration between the~     intensivist and other medical teams in ward can reduce ICU readmission and hospital~     mortality after ICU discharge.~   "
34941|NCT02599623|"~     This prospective randomized is designed to evaluate the safety and efficacy of hernia~     repairs using local anesthesia compared with those using general anesthesia for patients~     with incarcerated hernia.~   "
34919|NCT02599909|"~     Background:~      There are about 100 trillion microbial cells in a person s gut. This is called the human gut~     microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut~     microbiota in people with cancer is different than that found in healthy people. Researchers~     want to study links between the gut microbiota and the immune system in people with a liver~     disease called hepatocellular carcinoma (HCC).~      Objective:~      To study links between gut microbiota and the immune system in people with HCC.~      Eligibility:~      People at least 18 years old with HCC. They must be scheduled to have tumors removed by~     surgery.~      Design:~        -  People having surgery for primary liver tumors at the Mount Sinai Medical Center will~          be screened for this study.~        -  At the initial visit, blood, rectal swabs, urine, and stool will be collected.~          Participants will answer questions about their medical condition.~        -  Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be~          done at a routine visit.~        -  When they have surgery, a piece of liver tissue with the tumor will be collected. This~          will be sent to the National Cancer Institute for tests.~        -  After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This~          will be done at routine visits.~   "
34920|NCT02599896|"~     Background:~      Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus.~     HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.~     Researchers want to see if it does this in people.~      Objectives:~      To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is~     maintained in people and if they develop an immune response to it.~      Eligibility:~      Healthy people ages 18 to 50~      Design:~      Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical~     history, physical exam, and blood and urine tests.~      The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.~      Participants will get VRC01LS through either:~        -  A needle in an arm vein or~        -  A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or~          arm.~      Participants will be assigned to 1 of 6 groups.~      Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24.~      Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5~     visits between the second and third dose, and follow-up visits through week 48.~      Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They~     will record their temperature and keep a diary of symptoms for 3 days after a dose. They may~     have additional unscheduled visits.~      At each visit, participants will have a physical exam and may have blood and urine tests.~   "
34921|NCT02599883|"~     Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of~     chronic morbidity and mortality worldwide. There is debate about diagnosis and management of~     COPD because it was described as complex syndrome accounting for various pulmonary and~     extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation~     and pulmonary function tests (PFTs) data by themselves do not adequately describe the~     complexity of the disease. The chest radiograph is the sole imaging examination recommended~     for the routine evaluation of these patients by the physicians guidelines (GOLD~     guidelines),which, however, are also debating on the utility of computed tomography (CT) in~     this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the~     chest for COPD assessment, in both clinical and research settings. COPD assessment by CT~     seems to improve the accuracy and completeness of the clinical evaluation of these patients.~     Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or~     defined by guidelines.~      Objectives: To evaluate the change in the diagnosis and management of COPD when multiple~     CT-derived information is added to pre-test evaluation.~      Methods: Four pulmonologists with various expertise in the field will review clinical data,~     PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to~     current guidelines. Therefore, after two months from the first evaluation, the~     pulmonologists will review the clinical and PFTs records with comprehensive information~     about low-dose CT (LDCT) previously performed in a week from the chest radiograph.~     Information about LDCT findings will include qualitative assessment by an experienced chest~     radiologist and quantitative analysis by means of an innovative 3D imaging dedicated~     software. Phenotype assessment and patient care decisions (e.g. therapeutic and follow-up~     strategies, need of additional tests etc.) will be recorded before and after assimilation of~     LDCT data.~      Expected results: This evidence-based prospective study will test the impact of chest LDCT~     on management of COPD patient. In addition, the level of agreement between pulmonologists in~     terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will~     evaluate the need for additional tests referable to LDCT information and their impact on the~     health care system (e.g. in terms of additional costs).~   "
34922|NCT02599870|"~     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided~     treatment when implemented into the pre-operative process for patients undergoing an~     elective spinal surgical procedure and requiring post-operative acute pain management, as~     compared to a group of subjects with the same attributes without the guidance of PGx testing~     for their post-surgery pain management. This study will also evaluate whether PGx testing~     can reduce narcotic consumption, opioid-related adverse effects, time to mobilization,~     medical visits and costs.~   "
34923|NCT02599857|"~     Life expectancy of children with congenital heart disease (CHD) has increased dramatically~     during the past years, due to the successes of cardiac surgery. Nearly all of these children~     with CHD can be operated at young age and more than 90% reach adulthood. However, many~     adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart~     failure, putting them at risk of premature death. These events have a large impact on~     quality of life of patients and their families and merit life-long hospital visits in a~     medical center specialized in adult CHD. Especially for adults with CHD patient care with a~     smartphone is suited because of their young age and chronic condition. So far, data are~     lacking on smartphone interventions in patients with CHD.~   "
34924|NCT02599844|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated~     in the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
34925|NCT02599831|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than pelvic floor muscle training plus transanal electrical stimulation in~     treating post prostatectomy Incontinence.~   "
34926|NCT02599818|"~     This study will examine the clinical effectiveness and health economic profile of services~     to link hospital patients with substance use disorders to addiction treatment, promote their~     medical stabilization, and reduce hospital re-admissions.~   "
34962|NCT02599337|"~     Randomized, open-label, 3-way reference replicated crossover bioequivalence study of~     sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects~     under fasting conditions.~   "
34927|NCT02599805|"~     Diabetic foot complications care represent a significant burden to the Canadian healthcare~     system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than~     $150 million. A small sized randomized controlled trial (n=17) investigating the use of~     topical oxygen therapy (n=9) against placebo (n=8) for diabetic ulcers was done recently and~     showed a 87% average reduction of ulcer size in treatment group versus 46% average reduction~     in the control group (p<0.05).~      Despite the standards of care used today in diabetic foot ulcer treatment, wounds may be~     non-healing when they do not heal within the appropriate time frame expected by an~     experienced clinician. Current diabetic foot ulcer standards of care include: full medical~     assessment in all cases, surgical intervention where indicated and local treatment of the~     ulcer.~      Given the scarcity of controlled trials specifically designed to review the effects of~     topical oxygen in ulcer care, this study will contribute to the understanding of the~     management of these ulcers by assessing the reductions in ulcer size achieved using Natrox™~     topical oxygen therapy.~   "
34928|NCT02599792|"~     Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and~     multiple-ascending doses of CTP-656 dosed for 7 days.~   "
34929|NCT02599779|"~     This study is designed as a phase-II proof of concept trial to investigate if a treatment~     strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is~     sufficiently active to warrant further investigation in randomized phase II or III studies.~     Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more~     likely to have larger more aggressive tumours and reduced survival and renal tumours that~     express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand~     interaction with monoclonal antibodies can restore the activity of tumour specific T-cells~     within the tumour with durable responses documented in early clinical trials in several~     tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to~     directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be~     given to the 1-3 most clinically significant lesions at the time of progression on~     pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the~     activity of pembrolizumab. A total of 35 patients refractory to the approved first line~     therapy with a targeted drug (Sunitinib or Pazopanib) will be enrolled on study. This group~     of patient has a poor outcome on any other 2nd line therapy and urgently need novel therapy.~   "
34930|NCT02599766|"~     The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial~     effects on patients with brain injuries. This study investigates the short-term~     biopsychosocial effects that occur when animals are present during therapy sessions in~     comparison to therapy sessions without animals, observing a group of 25 patients over 24~     therapy sessions. While half of the sessions are held in presence of an animal and half~     without, they are as comparable as possible with respect to content and setting. In this~     study, patients who are in a slightly advanced rehabilitation process, assessed via their~     function profile, are investigated.~   "
34931|NCT02599753|"~     The objective of this protocol is to investigate the microstructural alterations and~     monoaminergic function in Parkinson's disease patients with impulse control disorders and~     cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.~   "
34932|NCT02599740|"~     This study is designed to test bioequivalence of a assumed key active compound vs. natural~     fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood~     glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for~     assumed key active compound vs. natural extract falls between 0.8 - 1.25.~   "
34933|NCT02599727|"~     Determine the effects repeated isometric exercises have on balance, blood pressure, heart~     rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a~     subject can process information and make decisions based upon that information).~   "
34934|NCT02599714|"~     This dose finding/extension study consists of three parts: Part A will identify the MTD of~     the AZD2014/palbociclib combination on a background of fulvestrant (referred to as the~     triplet) in postmenopausal women with locally advanced/metastatic estrogen receptor positive~     (ER+) breast cancer. Part B will further characterize safety, tolerability, PK, drug-drug~     interaction and preliminary efficacy in 3 single-arm dose expansion groups. Part C will~     investigate the efficacy of the triplet combination in a double-blind, placebo-controlled,~     stratified, parallel group extension.~   "
34935|NCT02599701|"~     The primary objective of this study is to evaluate the effects of gabapentin in sleep~     polysomnography parameters and in nocturnal secretion of endogenous~     hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic~     axes hormones and basal IGF-1 in older men.~   "
34936|NCT02599688|"~     This is an open-label, observational extension of patients who received POLAT-001 in~     LipoLat-CS202.~   "
34937|NCT02599675|"~     This study evaluates the effect of vitamin D supplementation on outcomes muscle performance~     and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be~     allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion~   "
34938|NCT02599662|"~     Currently, for patients with pancreatic cancer the standard treatment is surgery followed by~     chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery~     and treat the area of the tumor with intraoperative radiotherapy in one procedure.~     Intraoperative radiation delivers low energy x-rays to a targeted area during the time of~     tumor removal.~      The purpose of this study is to learn about both the good and bad effects of adding~     intraoperative radiation therapy. Another goal is to determine and compare the quality of~     life before and after the procedure. We will also monitor the effect of the therapy on the~     cancer lesion and any complications that may result.~   "
34939|NCT02599649|"~     The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab),~     alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of~     these drug combinations will also be studied.~   "
34963|NCT02599324|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in~     selected advanced gastrointestinal and genitourinary tumors.~   "
36156|NCT02583750|"~     This project investigated how glucose metabolism differs due to sleep deprivation for three~     consecutive nights as compared to sufficient sleep for three nights by examining~     concentrations of glucose, insulin, and other factors involved in glucose metabolism.~   "
34942|NCT02599610|"~     Digital vaginal examination is the most common method for assessing progress of labor and~     delivery. Considering it is the most common intervention women receive during course of~     labor, evidence for psychological effects of digital vaginal examination on women is~     surprisingly sparse. Reducing the number of vaginal examination during labor has been~     proposed by many authors as benefit of more vaginal examination is unclear. However this is~     unlikely to happen until more research on the topic demonstrates clear detrimental effects~     of vaginal examination.~      Our study is aimed at investigating association of vaginal examination with psychological~     distress of women during labor. Anxiety during labor is associated with longer labor~     duration, increased perception of pain, problems with newborn attachment, and increased~     rates of postpartum depression and post-traumatic stress disorder. In this study, women were~     assigned to either digital vaginal examination or transperineal ultrasound assessment groups~     were compared to each other in a randomised controlled setting.~   "
34943|NCT02599597|"~     Depression treatments including physical activity and sleep management has been shown to~     relieve depressive symptoms among participants suffering depressive episodes. This study~     evaluates the potential of these methods as prevention of depressive relapse or recurrence~   "
34944|NCT02599584|"~     Simulated environment allowed safe learning of critical events and knowledge of appropriate~     response and treatment. Anesthesiology resident education curriculum in Lyon plans several~     high fidelity simulation session with a large panel of critical events. Anticipation of~     critical events before they may occur and plannification of team resources and priority in~     the treatment strategy may help to improve team performance during the scenario. The~     investigators' goal is to compare team performance during the scenario with or without a~     liberal preparation team staff of 4 min, suggested after the briefing of the scenario but~     before the scenario starts.~   "
34945|NCT02599571|"~     The purpose of this study is to investigate the impact of different nicotine levels in~     cigarettes with individuals who have ADHD.~   "
34946|NCT02599558|"~     This study is being done to see if the investigators can use only the cytosponge ( A 10~     minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies~     routinely perform during dietary restriction and food reintroduction in EoE?~   "
34947|NCT02599545|"~     Very low birth weight (VLBW) infants have more health and developmental problems than normal~     birth weight full-term infants. These problems are more common in males than female VLBW~     preterm infants. Male VLBW infants also experience less positive mother-infant interactions~     than females, especially when mothers are emotionally distressed. This is a significant~     problem because positive mother-infant interactions function as an important protective~     factor against the negative health and developmental outcomes associated with prematurity.~     The source of the vulnerability of male VLBW infants to health problems, suboptimal~     mother-infant interactions, and poor development goes beyond gender socialization~     differences and includes biological factors. Identification of infant and maternal~     biological markers/predictors of infant health and developmental outcomes could ultimately~     lead to interventions for VLBW preterm infants.~      The purpose of this study is to confirm that testosterone rather than cortisol is a more~     reliable marker/predictor of complications affecting infants' health outcomes, mother-infant~     interactions, and infant cognitive/motor/language developmental outcomes; and that male~     infants exhibit a higher sensitivity to testosterone levels than female infants.~      This longitudinal study will examine the associations of the steroid hormones, testosterone~     and cortisol, levels with infant health, mother-infant interactions, and infant~     cognitive/motor/language development ('infant development') in very low birthweight (VLBW,~     BW < 1,500 g) preterm (gestational age < 32 weeks gestation) infants after adjusting for~     maternal physical and mental health state, infant socioemotional and behavioral development,~     and characteristics of infants and mothers. Concurrent and repeated measurement of~     testosterone and cortisol levels both in infants and mothers will be conducted through~     infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months~     corrected age).~   "
34948|NCT02599532|"~     The nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia, and~     patients with nephrotic syndrome are known to be hypercoaguable with increased incidence of~     venous thromboembolism necessitating anticoagulation. While classically warfarin has been~     used as an anticoagulant in NS, newer oral anticoagulants, such as apixaban, are~     increasingly used to treat venous thromboembolism (VTE) in the general population. It is~     unknown how hypoalbuminemia and proteinuria affect the pharmacokinetics and pharmacodynamics~     of apixaban. This study is to investigate the pharmacokinetics and pharmacodynamics of~     apixaban in nephrotic syndrome.~   "
34949|NCT02599506|"~     This pilot study concentrates on studying the trajectory of breast cancer patient's fear of~     recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated~     ratings of 100 breast cancer patient's FoR over the course of their treatment. It is~     hypothesized that cancer patient's FoR level will rise on nearing the termination of the in~     radiotherapy treatment, and radiotherapist-patient interaction modifies the development of~     patient's FoR.~   "
34950|NCT02599493|"~     Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp.~     osteo-articular infections, most frequently in association with a fluoroquinolone when the~     strain is susceptible to both agents. It is the reference treatment for orthopedic~     infections with implanted material.~      For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the~     treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by~     French experts' recommendations from 2009.~      However, there is little evidence in the literature, which could set out arguments to choose~     the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.~      The issue with rifampicin is side effects, in particular with long-term treatment. Many side~     effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or~     treatment interruption.~      In the literature, there is little evidence that higher rifampicin dosage is associated with~     higher frequency of adverse effects. Depending on the nature of the toxicity, one could say~     that hypersensitivity could be independent from dosage, when digestive disorders may be~     related. Plasmatic concentrations studies have not given strong arguments to link higher~     rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak~     occurs after two to five hours and varies among individuals but also in the same patient~     overtime. This particular pharmacokinetic profile could explain discrepancy in adverse~     events (AEs) frequencies.~   "
34951|NCT02599480|"~     This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the~     prevention of heart failure. This is a two armed, prospective, randomized,~     placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron~     distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling~     with or without symptoms of heart failure (maximum NYHA II).~      Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI)~     and/or changes in diastolic function (assessed by echocardiography) after 12 months of~     treatment.~   "
34976|NCT02599155|"~     The investigator will evaluate the influence of colloid administration on postoperative~     acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary~     bypass.~   "
34952|NCT02599467|"~     Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients~     often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test~     for the median nerve, called upper limb neurodynamic test 1 (ULNT1). Design: A matched~     case-control observational study. Objective: to check the increased upper limb~     mechanosensitivity by shoulder range of motion (ROM) during ULNT1 and to determine, for the~     first time, the evoked electromyographic (EMG) muscle activity. Participants: 62 cases who~     underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital,~     Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity~     during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity,~     breast cancer, pain, EMG, shoulder ROM, median nerve.~   "
34953|NCT02599454|"~     This phase I trial studies the side effects and best dose of atezolizumab that can be given~     together with stereotactic body radiation therapy in treating patients with stage I~     non-small cell lung cancer that cannot be removed by surgery. Monoclonal antibodies, such as~     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body~     radiation therapy is a specialized radiation therapy that delivers a single, high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to~     normal tissue. Giving atezolizumab together with stereotactic body radiation therapy may~     kill more tumor cells and be a better treatment for non-small cell lung cancer that cannot~     be removed by surgery.~   "
34954|NCT02599441|"~     To compare measures of ankle stability from an investigational cone beam computed tomography~     scanner to gravity stress X-ray in patients who have unstable supination-external rotation~     ankle fractures.~   "
34955|NCT02599428|"~     This project aims to investigate the physical, mental and cognitive recovery after admission~     to the Intensive Care Unit (ICU).~      This will be done by a three and 12 month follow up after discharge. The patients will be~     scored with four validated methods for evaluating their health related quality of life,~     anxiety and depression, cognitive function and physical impairments~   "
34956|NCT02599415|"~     This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the~     resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells~     were reported to have a role in induction of tolerogenic regulatory T cells and production~     of IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of~     cells after two weeks of treatment to provide better understanding of the mechanism of~     action of light treatment.~   "
34957|NCT02599402|"~     The purpose of this study is to determine the effects of combination treatment of Nivolumab~     with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated~     advanced Melanoma.~   "
34958|NCT02599389|"~     The aim of this multicenter triple-arm randomized study is to compare two innovative~     techniques with the gold standard currently used and providing unsatisfactory results for~     the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares~     the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with~     the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole~     fibrous material to the standard angioplasty using plain balloons. INTACT study main~     objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery~     in-stent restenosis by comparing these two innovative strategies and the standard one in~     terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective~     perspective.~   "
34959|NCT02599376|"~     Obesity has become one of the most common risk factors in obstetric practice with serious~     anaesthetic implications. Obese pregnants have limited physiological reserves and~     cardiovascular co- morbidities when compared to non-obese pregnant women. Spinal anaesthesia~     is the anaesthetic technique of choice for caesarean section. The haemodynamic changes~     associated with spinal anaesthesia pose the greatest hazard to the mother and the foetus and~     are exaggerated in obese pregnant women. However differences in the changes in haemodynamic~     variables such as cardiac output (CO), stroke volume (SV) and systemic vascular resistance~     (SVR) between obese and non-obese pregnant women having caesarean section (CS) under spinal~     anaesthesia have not been studied before. This study compares the haemodynamic changes after~     spinal anaesthesia for CS in non-obese and obese parturients in a single centre, prospective~     case control study, using LiDCOrapidV2. This LiDCOrapidV2 device is a noninvasive method of~     measuring haemodynamic variables. It is a single centre, prospective, case control study.~     The primary outcome compares the differences and variability in CO, SV and SVR between obese~     and non-obese parturients. The secondary outcomes include comparison of the correlation~     between changes in blood pressure (BP) and CO in each patient and the difference in BP~     between conventional intermittent oscillometric device and continuous LiDCORapidV2in each~     patient with a view to assess the need for measurement of cardiac output in obstetric~     anaesthesia~   "
34960|NCT02599363|"~     This is a Phase I study to assess the safety and MTD of paclitaxel + ribociclib (LEE011) in~     patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard~     3 + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose~     escalation proceeds in 200 mg increments up to a maximum of 600 mg. Dose-limiting toxicities~     (DLT) will be based upon first-cycle toxicity.~   "
34961|NCT02599350|"~     In an attempt to standardise the degree of impairment of gas exchange in the lungs of ICU~     patients a number of indices of oxygen exchange have been developed. These include: the~     arterial−alveolar oxygen tension ratio (a/APO2), the arterial oxygen tension−inspired oxygen~     concentration ratio (PaO2/FIO2), the respiratory index (RI), [A−a)DO2/PaO2) and the~     alveolar−arterial oxygen tension difference [A−a)DO2). These are used clinically despite the~     fact that they do not accurately predict gas exchange particularly with changing the amount~     of inspired oxygen or when there is mixing of oxygenated blood with unoxygenated blood in~     the patient (called shunt). None of the indices reliably reflect the behaviour of the~     physiological shunt. In a pilot study as inspired oxygen (FIO2) was increased incrementally~     from 0.30 to 1.00, up to 55 per cent of the measured changes in these indices were opposite~     in direction to the corresponding changes in the physiological shunt. The investigators have~     developed a computer algorithm and a slide rule to try and improve on these clinical~     measures. The investigators wish to test their slide rule on ventilated patients by altering~     the inspired oxygen to see if it will predict what the actual change in oxygen will be.~   "
34964|NCT02599311|"~     One thousand patients with stage＞2 POP are recruited. The patients are all received~     surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair~     surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded.~     Postoperatively, the investigators investigate the indications and clinical efficacy of~     pelvic organ prolapse surgery.~   "
34965|NCT02599298|"~     The aim of this randomized, open-label clinical trial is to determine the impact of Sleep~     Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and~     behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute~     coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a~     lower (1) plasma NT-pro BNP level, (2) 10-year risk of cardiovascular mortality based on the~     European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard~     Therapy.~      OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a~     prevalent and independent predictor of adverse outcomes in patients with acute coronary~     syndrome. In this clinical trial, a continuation of my research and publication trajectory,~     180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT~     (n=90) or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated~     treatment for acute coronary syndrome. Those assigned to SGMT will undergo a sleep study.~     Those found to have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice~     on continuous positive airway pressure and behavioral therapy (weight loss, exercise,~     positional therapy, abstinence of alcohol and sleeping pills) will be given. The primary~     endpoint is plasma NT-pro BNP concentration at 6-month follow-up. The secondary endpoint is~     10-year risk of cardiovascular mortality based on the European SCORE algorithm which~     includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or~     total/HDL-cholesterol ratio. Adverse cardiovascular events at 3-year follow-up will be~     determined.~      In our aging population with an increasing prevalence of obesity, OSA will potentially~     become an increasingly important contributor to cardiovascular disease. Leveraging the~     collective expertise of a team of cardiologists and sleep physicians, our work will benefit~     society by advancing our understanding of the cardiovascular benefits of screening for and~     treating OSA.~   "
34966|NCT02599285|"~     In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a~     medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair~     and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint.~     Widening and chronical instability of the syndesmosis is related to worse functional outcome~     and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical~     and clinical evidence that syndesmotic stability in AO Weber type C fractures with an~     additional posterior malleolar fracture can also be reached by fixation of the posterior~     malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic~     positioning screws. Some authors concluded that stability of the syndesmosis in these~     fractures can be much more achieved by fixation of the posterior malleolar fragment than by~     placement of syndesmotic positioning screws alone. Another additional benefit of open~     reduction and fixation of the posterior malleolar fragment is that this will lead to an~     anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is~     likely that a malreduction of the fibula in the tibial incisura will lead to a worse~     functional outcome on the long-term. No clear consensus in the literature is found as to~     which fragment size of the posterior malleolus should be internally fixed. The general~     opinion is that displaced fragments that involve more than 25% of the distal articular tibia~     should be fixed. Traditionally, reduction of these larger fragments is indirectly, followed~     by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is~     hard to achieve an anatomical reduction, and that percutaneous fixation of smaller fragments~     is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral~     approach in prone position, followed by open reduction and fixation with screws in~     posterior-anterior direction or antiglide plate is advocated by several authors. This~     approach allows perfect visualization of the fracture, articular anatomical reduction, and~     strong fixation. Another advantage is that even small posterior fragments can be addressed.~     Several case series are published, which describe minimal major wound complications, good~     functional outcomes, and minimal need for reoperation.~   "
34967|NCT02599272|"~     The study will investigate whether having mixed spices rich in polyphenols can improve~     postprandial cardiometabolic response in healthy Chinese men.~   "
34968|NCT02599259|"~     AiCure uses artificial intelligence and visual recognition technology to confirm medication~     ingestion. The software is available as an app and downloaded onto a smart phone. The~     single-site, parallel-arm, randomized controlled trial will test the feasibility and impact~     of using the platform in a stroke population. End points: usability, consistent use of the~     device, and optimization of treatment.~   "
34969|NCT02599246|"~     The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2~     with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.~   "
34970|NCT02599233|"~     The main objective of this study is to establish the postoperative pain pathways observed~     from D1 to D7 in the context of the current management after orthopedic, digestive,~     obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.~   "
34971|NCT02599220|"~     This study examines the clinical outcomes and healthcare costs associated with gram negative~     bacteremia at Duke University Medical Center from 2002-2015.~   "
34972|NCT02599207|"~     This study is a single site, phase I, prospective study of the safety of intravenous sibling~     cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects~     will be treated with sibling cord blood cells. The first six will receive cord blood cells~     from an HLA-matched sibling. The following nine subjects will receive cord blood cells from~     an HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will~     be six months from the time of the cord blood infusion.~   "
34973|NCT02599194|"~     The goal of this Phase II clinical trial is to further evaluate the ability of 18F-FSPG to~     diagnose, prognosticate, and evaluate response to therapy in patients with a wide variety of~     metastatic cancers.~   "
34974|NCT02599181|"~     The aim of this study was to investigate the influence of alcoholic skin disin-fection~     before PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous~     part of the PNC or on the tip. Furthermore, the correlation of bacterial colonization with~     PNC-associated local inflammation or infection was evaluated.~   "
34975|NCT02599168|"~     Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in~     intensive care patients in receipt of mechanical ventilation, is being increasingly utilized~     in anaesthesia practice for facilitating anaesthesia depth as an adjunct to base~     anaesthetics (intravenous; propofol: inhalational; sevoflurane, desflurane). The~     investigators intend to assess the anaesthetic potential of dexmedetomidine in controlled~     anaesthesia settings empowered by the use of an objective, patient response based, safe,~     efficient, and patented closed loop anaesthesia delivery system (CLADS). CLADS functions on~     control of processed EEG response parameter captured from anaesthetized patients with the~     help of a BIS- monitor, which is continuously fed into a automated drug infusion pump. The~     infusion pump then accordingly delivers the anaesthetic drug to the patients based on~     pharmacodynamic requirements. If dexmedetomidine has anaesthesia potential then it is likely~     that propofol use delivered by CLADS can be reduced further. In addition the effect of two~     drugs (viz, base agent-propofol plus adjunct agent-dexmedetomidine) on different receptor~     site within the brain would help gain greater anaesthetic depth consistency as well as a~     lower incidence of intraoperative patient awareness. This prospective randomized two-arm~     study aims to assess effect of the use of dexmedetomidine on propofol requirements (primary~     objective), anaesthesia depth consistency, and intraoperative patient awareness (secondary~     objectives).~   "
34977|NCT02599142|"~     Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent~     patient movement and improve treatment accuracy. These shells tend to cover the face and~     have the potential to cause anxiety and distress in patients, particularly if they suffer~     with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not~     cover the face and compare this with the investigators' current 'closed-face' shell. The~     investigators will obtain treatment verification x-ray images to assess the daily set-up~     errors and compare these between the two shell type, and ask both patients and radiographers~     of their experiences from using the shells.~      Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of~     radiotherapy delivery and are better accepted by patients and radiographers as compared to~     closed-face immobilisation shells for cranial radiotherapy.~   "
34978|NCT02599129|"~     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can~     fall out on the scalp or elsewhere on the face and body.~      Alopecia areata is an autoimmune skin disease, which means that the immune system is~     recognizing the hair follicles as foreign and attacking them, causing round patches of hair~     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss~     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any~     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs~     in males and females of all ages, and is a highly unpredictable condition that tends to~     recur. Alopecia areata can cause significant distress to both patients and their families.~      Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia~     areata. A total of 30 patients will be included in the study, which will run for a total of~     28 weeks.~   "
34979|NCT02599116|"~     This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with~     peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic~     intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and~     post-operatively.~   "
34980|NCT02599103|"~     Fats and oils play important roles in maintaining human nutrition and health through~     providing energy, essential fatty acids, and acting as modulators of many biological~     processes (signal transduction, immunity and inflammation). Due to differences in the fatty~     acid composition and content of antioxidants of individual cooking oils, the degree of~     oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study~     to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse~     effects. The investigators are also lack of biomarkers for monitoring deep-fried oil~     exposure. Therefore, the purpose of this study is to compare how human body responds~     differently to several popular uncooked and deep-fried oils with varied fatty acid~     compositions with respect of oxylipin profile, inflammatory markers, non-targeted~     metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided~     them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil,~     camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in~     comparison with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time;~     serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and~     after 4 hours. The investigators anticipate to find biomarker(s) for deep-frying, and~     contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse~     effects toward health through integrative omics or so-called system biology approaches.~   "
34981|NCT02599090|"~     The goal of this clinical research study is to find the highest tolerable dose of sorafenib~     that can be given in combination with temozolomide. The safety of this combination will also~     be studied.~   "
34982|NCT02599077|"~     Project Summary Endometriosis is a disease with a high prevalence that primarily affects~     women of childbearing age. This condition brings an important physical and emotional burden~     on sufferers and this is why it requires proper and timely medical management. At present~     there are several first-line drugs available for the management of symptoms and disease~     control. In the world literature we have reported several studies that demonstrate the~     effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH~     analogues and danazol. Within the available scientific evidence it has been extensively~     described the benefits of the new progestins Dienogest, demonstrating a favorable safety~     profile and efficacy along with a significant reduction of the symptoms of the disease by~     its anti-inflammatory, and antiproliferative antiagiogénicas in the endometrial tissue .~     However, although the therapeutic properties of this drug are known, studies are needed to~     compare its effectiveness with the effectiveness of other therapeutic agents as oral~     contraceptives. That is why the main objective of this study is to evaluate the impact of~     Dienogest to 2 mg / day compared with a combined oral contraceptive (levonorgestrel +~     ethinyl estradiol) in the size of the endometriomas diagnosed by transvaginal~     ultrasonography in 50 women having diameters less than 4 centimeters of the same, which~     medical management will be given for one year at the University Hospital Fundación Santa Fe~     de Bogota. The study was conducted by a clinical trial, randomized, single-blind by the~     observer. The results will be analyzed and the findings in the study will serve as a tool to~     define new therapeutic conduct in the management of endometriosis.~   "
34983|NCT02599064|"~     This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109~     administered by intravitreal injection to reduce the progression of subretinal fibrosis in~     subjects with advanced neovascular age-related macular degeneration (NVAMD).~   "
34984|NCT02599051|"~     A randomized control trial to compare the efficacy of the single incision mini-sling to the~     transobturator sling~   "
34985|NCT02599038|"~     In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD~     patients by short-term dietary serine supplementation and improve their liver function by~     lowering the oxidative stress resulting from hepatic steatosis.~   "
34986|NCT02599025|"~     The investigators will examine the immediate contribution of position and movement on the~     functioning of the autonomic cardiac control system.~   "
35007|NCT02598752|"~     The purpose of this study is to see if exercise fitness testing, is feasible and safe in~     persons over 50 years of age who have been diagnosed with acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS) and who are scheduled to undergo a hematopoietic stem cell~     transplant (HCT). Assessments in this study include several physical tests to look at the~     capacity of your body before and after transplantation to see if these measures can help~     predict how patients do after transplant.~   "
34987|NCT02599012|"~     -  Multifactorial pathogenesis is involved in anemia of cancer patients and defining the~          causes of anemia is not always simple.~        -  Currently, treatment options available for anemia in cancer patients include red blood~          cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron~          supplementation, accompanying considerable pros and cons for each treatment.~        -  Previous studies have demonstrated benefit when treating with IV iron in combination~          with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.~        -  In this study, investigator will assess the efficacy of intravenous iron for the~          treatment of anemia in cancer patients.~   "
34988|NCT02598999|"~     This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple~     ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their~     combination (ALX-009) in healthy male volunteers and patients suffering from cystic~     fibrosis.~   "
34989|NCT02598986|"~     Glycemic index (GI) of food is known to be positively associated with the development of~     several diseases including type 2 diabetes, cardiovascular disease and age-related macular~     degeneration. Modest dietary changes from high-GI foods to low-GI foods have shown~     beneficial effects. These findings have been translated to recommendations for increased~     dietary intake of whole grains. However, the inverse relationship between whole grain~     consumption and risk of the different components of metabolic syndrome has not been~     explained by their fiber content. Trials of added cereal fiber have failed to induce a~     protective effect and fiber has thus been proposed to be a marker of other components of~     whole grains that impart health advantages. Whole wheat grains are known to be a rich source~     of several minerals (phosphorus, potassium and magnesium) that play a role in glucose~     metabolism, and are depleted during the process of refinement. Thus, it is plausible to~     hypothesize that the benefits of whole grains previously ascribed to their fiber content are~     in fact due to these minerals. The proposed research aims to restore or fortify white bread~     with these minerals and determine the resulting glycemic index of mineral-fortified bread.~     With much evidence that most people prefer the taste and color of white bread, a low GI,~     mineral fortified white bread has the potential to reduce the risk of Metabolic Syndrome in~     those who consume it.~   "
34990|NCT02598973|"~     Parkinson's disease (PD) is a common neurodegenerative disorder affecting approximately~     80,000 Veterans, representing a priority area for VA research. Current medicines for PD only~     improve symptoms, treatments that slow disease progression are needed, and earlier diagnosis~     of PD may be the key to their development. PD symptoms can be mimicked by medicines (most~     commonly antipsychotic drugs that block dopamine), and some of these patients actually have~     underlying prodromal PD that was unmasked years before it would have caused symptoms.~     This problem is increasing as these medicines are now used for common conditions including~     post-traumatic stress disorder and depression. The investigators will identify prodromal PD~     in patients with drug-induced symptoms using brain scans. These patients will be enrolled in~     a randomized clinical trial of aerobic exercise which slows progression in animal models of~     PD and has other health benefits. The investigators will measure the effect of exercise on~     symptoms, disease progression (using brain scans) and markers of PD risk (using blood~     tests). These studies will improve early PD diagnosis and potentially identify a way to slow~     progression of PD.~   "
34991|NCT02598960|"~     The purpose of this study is to evaluate the safety, tolerability pharmacokinetics,~     pharmacodynamics, immunogenicity and preliminary anti-tumor activity of BMS-986156 when~     administered alone and in combination with nivolumab in subjects with advanced solid tumors.~   "
34992|NCT02598947|"~     Shoulder impingement syndrome is a very common cause of shoulder pain and normally treated~     with physiotherapy or surgery. Research has shown that physiotherapy is as effective as~     surgery, however, the incidence of surgery for this condition is on the rise~     internationally, nationally and locally. The most effective form of physiotherapy, however,~     is not known. Laboratory studies have suggested that posterior shoulder tightness may~     contribute to irritation of the soft tissue around the shoulder joint and perpetuate pain~     from shoulder impingement syndrome. There is a lack of good quality evidence to support this~     perspective. The aim of this study is to assess the feasibility of conducting a randomized~     controlled trial to evaluate the effectiveness of treatment for posterior shoulder tightness~     in combination with 'best care' compared with 'best care' alone in individuals with shoulder~     impingement syndrome.~      The study will be a randomised, controlled, double blind (patient and assessor), parallel~     group, feasibility study with 1:1 allocation ratio. Patients awaiting surgery will be~     assessed for inclusion/exclusion criteria and then randomly allocated into one of two~     groups. 60 patients will be assigned to receive 'best care' physiotherapy, with or without~     treatment for posterior shoulder tightness.~      Physiotherapy treatment will be delivered over 13-15 weeks and outcomes will be assessed at~     0, 6-8, 13-15, 26 and 52 weeks. The results will help us to understand if this is an~     important part of physiotherapy treatment, which might help reduce patient's pain and~     disability as well as reduce the cost of treatment for the National Health Service.~   "
34993|NCT02598934|"~     This study will evaluate whether an early positive response to once-monthly oral ibandronate~     in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy~     later in treatment. The anticipated time on study treatment is 6 months, and the target~     sample size is 360 individuals.~   "
35008|NCT02598739|"~     The aim of this study was to assess the effectiveness of resistance training in improving~     functional capacity, muscle strength, quality of life and disease activity in patients with~     PSA.~   "
35009|NCT02598726|"~     This pilot phase I trial studies the side effects and best dose of curcumin when given~     together with piperine (piperine extract [standardized]) in reducing inflammation for~     ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to~     turmeric and works by decreasing the chemical moderators that produce inflammation in the~     body. Piperine is pepper and works by increasing the amount of curcumin available in the~     body when taken with curcumin. Giving curcumin together with piperine may reduce~     inflammation and discomfort from a ureteric stent in older patients with cancer.~   "
35010|NCT02598713|"~     The goal of this interventional study is to test Quinine, Red and Blue food dye as markers~     of aspiration (endotracheal tube [ETT] cuff leakage) in mechanically ventilated, critically~     ill patients.~   "
34994|NCT02598921|"~     Evaluation of the endometrial cavity is an important step in the infertility work-up,~     particularly if assisted reproductive therapy is planned. The aim is to identify possible~     endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities~     are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally,~     two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the~     basic methods for assessment of the endometrial cavity. However, these imaging modalities~     have shown high false negative rates among infertile women, a finding that could confine~     their rule to initial screening rather than definite diagnosis.~      Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity.~     Although the endoscopic approach has been proven to increase pregnancy rate in women who~     experienced prior implantation failure, evidence on treatment of unsuspected~     hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking.~     Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and~     financial burden that infertile couples may experience as a consequence of failed IVF cycle~     is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to~     all women prior to IVF.~   "
34995|NCT02598908|"~     Participation in EQA schemes, where available, is mandatory for the United Kingdom~     Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine~     metabolites, which is a potential shortcoming of these tests. A pilot of this project has~     been awarded funding by Clinical Pathology Accreditation (CPA).~      The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT~     (activity and genotype) and thiopurine metabolites, which will be run in collaboration with~     UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a~     comprehensive world-wide service that enables laboratories providing these tests to fulfil~     quality goals and ultimately provide optimal patient care.~   "
34996|NCT02598895|"~     This pilot clinical trial studies docetaxel and carboplatin in treating patients with~     prostate cancer that does not respond to treatment with hormones (hormone resistant) and~     that has spread from the primary site (place where it started) to other places in the body~     (metastatic). Drugs used in chemotherapy, such as docetaxel and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
34997|NCT02598882|"~     Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after~     two physical activities, being one of an activity guided by interactive video game (Xbox)~     and another on the treadmill. The participants will perform the activities in two different~     days, the order will be obtained by randomization.~   "
34998|NCT02598869|"~     Macular edema is the most common sight threatening complication of uveitis which can lead to~     permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for~     treatment of cystoid macular edema(CME) is well established. The purpose of this study is to~     compare the safety and efficacy of injecting the study drug inside the eye(intravitreal~     injection) and behind the eye(subtenon injection)~   "
34999|NCT02598856|"~     Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in~     Norway. The government is currently implementing a strategy for combating this epidemic.~     Among the actions promoted in this strategy is the distribution of naloxone for intranasal~     administration. Such administration of naloxone is currently being implemented and tried out~     around the world, but very little has been done to pharmacologically study this new route of~     administration of this well known drug, and only 3 open label randomized controlled trials~     (RCTs) have been conducted. A recent guideline from the WHO on community management of~     opioid overdoses is a comprehensive review of many of the aspects the investigators cover in~     our research.~      Regarding both dosage, routes of administration of naloxone and care of these patients in~     the pre hospital setting. The WHO calls for nasal formulations with a higher concentration,~     as well as focuses on the current wide spread off label use of nasal naloxone as a problem~     and identifies several research questions of critical importance and very low evidence.The~     current study, together with our research group's previous and future studies, aims to~     provide data for the development of a medicinal product with marketing authorisation for use~     in pre-hospital overdoses. This to contribute to public health measures for opioid users and~     those around them.~   "
35000|NCT02598843|"~     The purpose of this study is to directly compare traditional plaster treatment with early~     weightbearing in a walking boot for the non operative treatment of acute achilles tendon~     rupture.~   "
35001|NCT02598830|"~     This study evaluates the effect of vitamin D supplementation on outcomes of 12 weeks~     progressive strength training in 130 ageing subjects (>45 years of age). Participants will~     be recruited into two similarly sized strata; one containing COPD patients and one~     containing healthy subjects. In each stratum, half the participants will receive vitamin D~     supplementation and half the subjects will receive placebo~   "
35002|NCT02598817|"~     The purpose of this present study is to describe the acceptability and gastrointestinal~     tolerance of High-sn-2 infant formula in non-breast fed healthy term infants in the Middle~     East by parent-reported outcome measures and pediatrician reported outcomes.~   "
35003|NCT02598804|"~     The primary purpose is to evaluate the benefit of an education action of exercise on the~     level of physical activity in patients with knee osteoarthritis with the waning of a spa~     treatment for three weeks, three months after the start of the cure.~   "
35004|NCT02598791|"~     With the present study, the investigators aim to delineate the effects of GIP/GLP-1 receptor~     co-activity on food intake, appetite, bone health and fat metabolism in overweight/obese~     subjects.~   "
35005|NCT02598778|"~     This study compares four mouth rinses in their regard to reducing Streptococcus Mutans after~     use. The four mouth that will be compared are chlorhexidine gluconate (.12%), sodium~     fluoride (.05%), coconut oil, and deionized water.~   "
35006|NCT02598765|"~     The purpose of this study is to determine the reduction in intraocular pressure and~     cumulative incidence of complications between the standard and micro trabeculectomy~     surgeries 3 months after surgery.~   "
35055|NCT02598128|"~     Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that~     anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic~     fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral~     feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.~   "
35011|NCT02598700|"~     In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's~     safe zone and functional anteversion are often used to assess appropriate orientation.~     However, these approaches do not consider the effect of the spinopelvic chain and lumbar~     mobility when in the seated position. This study will measure functional anteversion when~     standing and sitting with patient-specific computer models and define a quantitative~     relationship between the change in functional anteversion and spinopelvic parameters. This~     will challenge the historical paradigm of the safe zone and provide a tool to define~     anteversion based on a patient's mechanics and reduce risk of dislocation.~   "
35012|NCT02598687|"~     Open-label, single-center phase 1 study of an investigational agent TH-302 and standard~     chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.~   "
35013|NCT02598674|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated~     in the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
35014|NCT02598661|"~     The purpose of this study is to evaluate the efficacy and safety of imetelstat in~     transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome~     (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.~   "
35015|NCT02598648|"~     In the clinical data, the changes of RIPK3 and FXR were monitored in the lung lavage fluid~     and blood from the patients.~      In vivo experiments to find high risk factors to induce AEC necrosis and further lead to~     ARDS evidence, can provide a more direct theoretical research foundation for the~     pathogenesis of ARDS.~   "
35016|NCT02598635|"~     Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces~     proteins levels associated with vascular calcification (osteoprotegerin, osteopontin,~     osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.~   "
35017|NCT02598622|"~     The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent~     painful nerve damage and nerve pain which is caused by vincristine, a drug used in~     chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug~     available for purchase as a nutritional supplement but for the purpose of this study is~     experimental.~   "
35018|NCT02598609|"~     Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account~     for a high morbidity and mortality. Possible severe adverse events are central line~     associated bloodstream infections (CLABSI), ventilator and catheter associated adverse~     events and medication errors. Severity of the patient's outcome after an adverse event can~     be classified using the National Coordinating Council for Medication Error Reporting and~     Preventing (NCC MERP) Index for categorizing medication errors.~      The study will test the hypothesis that rates of adverse events in NICU patients will be~     reduced by the implementation of an educational program for the NICU caregivers (nurses and~     physicians), consisting of strategies for recognizing and preventing adverse events in their~     unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal~     complications and ventilator and catheter-associated adverse events.~      This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in~     France will be randomized to the timing of implementation of the educational program.~      In order to describe the adverse events occurring during the study period, an anonymous~     voluntary adverse event reporting system will be provided to the caregivers of the~     participating units. A nested study will examine how caregivers communicate with the~     patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).~      The rates of adverse events will be measured retrospectively using a neonatal NICU trigger~     tool.~   "
35019|NCT02598596|"~     The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of~     pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in~     patients with chronic, refractory gout.~   "
35020|NCT02598583|"~     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of~     multiple IV doses of ALXN1210 administered to patients with PNH~   "
35021|NCT02598570|"~     This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese~     participants with relapsed or refractory lymphoma.~   "
35022|NCT02598557|"~     This randomized phase IIb trial studies how well alternative dosing of exemestane before~     surgery works in treating in postmenopausal patients with stage 0-II estrogen positive~     breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or~     coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer.~     Comparing the exemestane standard dose regimen versus two alternative, less frequent dose~     regimens may decrease undesirable symptoms and be more effective in treating breast cancer.~   "
35023|NCT02598544|"~     Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in~     obesity and diabetes. An important characteristic when examining AT function is the capacity~     to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the~     aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in~     different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects~     with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge~     gained from this research will contribute to a better understanding of the present adipose~     tissue dysfunction and to the optimization of exercise programs for people with obesity and~     diabetes.~   "
35024|NCT02598531|"~     The purpose of the SWIFT Trial is to answer two research questions.~        1. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative~          and long-term outcomes of TKA in extreme obesity?~        2. Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?~   "
35025|NCT02598518|"~     The purpose of this study is to assess the effectiveness and implementability of ICT for~     co-occurring alcohol use and mental health disorders within community addiction treatment,~     as delivered by routine community addiction clinicians.~   "
35026|NCT02598505|"~     The purposes of this study are:~        1. To confirm safety of Indacaterol in stable Heart Failure.~        2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to~          ameliorate lung diffusion in heart Failure patients treated with beta blockers.~        3. To compare the effects of Indacaterol in patients treated with a non-selective beta~          blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).~   "
35027|NCT02598492|"~     The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among~     mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to~     impute the PF ratios in assessing the respiratory parameter of the SOFA score.~   "
35028|NCT02598479|"~     The IPTLD QoL Broad Study.~   "
35029|NCT02598466|"~     Research question: what are the patterns of patient-reported changes in physical function~     among adult patients using SC abatacept with moderate to severe RA since commencement of the~     compassionate use program (CUP).~   "
35030|NCT02598453|"~     The purpose of this study is to evaluate treatment adherence to different regimens of~     ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to~     daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side~     effects. The anticipated time on study treatment is 12 months, and the target sample size is~     517 individuals.~   "
35031|NCT02598440|"~     This study will evaluate participant-reported preference for either ibandronate or a~     comparator drug in women with postmenopausal osteoporosis. The anticipated time of study~     treatment is 6 months, and the target sample size is 338 individuals.~   "
35032|NCT02598427|"~     The purpose of this research study is to determine how well pertuzumab and trastuzumab works~     in treating breast cancer that has spread to the brain. Pertuzumab and trastuzumab are~     treatments that stop breast cancer cells from growing abnormally by inhibiting (or blocking)~     members of a family of proteins that include Human Epidermal Growth Factor Receptor 2~     (HER2).~      Pertuzumab and trastuzumab have been found to be very effective for HER2-positive breast~     cancer and are FDA approved for treatment of metastatic breast cancer outside of the brain~     when given through the vein. This suggests that pertuzumab and trastuzumab may help shrink~     or stabilize HER2-positive breast cancer that has spread to the brain in this research~     study.~      In this research study, the investigators are looking to see whether pertuzumab and~     trastuzumab will work to decrease the size of or stabilize breast cancer that has spread to~     the brain.~   "
35033|NCT02598414|"~     In colorectal surgery, anastomotic leak and its septic consequences still remain as the most~     concerning complications resulting in substantial morbidity and mortality. A common~     determining factor for assessing the viability of a bowel anastomosis is adequate arterial~     perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared~     fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which~     allows the surgeon to choose the point of transection at an optimally perfused area before~     creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the~     robotic systems and this helps identify intravascular NIF signals in real time.~      Although reports from several case series and retrospective cohorts have described the~     feasibility and safety of this imaging system during robotic colorectal surgery, to date, no~     studies have addressed more systematically the outcomes of this technique in robotic~     surgery. Considering the limitations of these reports, investigators aim to conduct a~     prospective randomized trial to compare robotic procedures with or without INIF imaging in~     patients undergoing colorectal surgery.~   "
35034|NCT02598401|"~     The aim of this research is to examine the natural history of osteonecrosis in older~     children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic~     lymphoma within the UK. In addition to using and validating new, internationally agreed,~     standard definitions for osteonecrosis, this study will provide the data needed to develop a~     radiological classification which correlates with clinical status.~   "
35035|NCT02598388|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of~     different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly~     (IM) as heterologous prime-boost regimens in healthy and in HIV-infected adults.~   "
35036|NCT02598375|"~     Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill~     children in the PICU (ERTEN in PICU).~      In critically ill children, there is no data on the factors influenced the enteral nutrition~     and feeding intolerance.The investigators aim to reach these goals in our study~        -  To initiate the enteral feeding in pediatric intensive care units or not~        -  To demonstrate the reasons whether early enteral feeding is initiated or not~        -  To determine the incidence of feeding intolerance~        -  To identify the situations such as analgesia ,sedation, catecholamines or individual~          preferences of the medical staff which lead to delay or interruption in enteral feeding~          in pediatric intensive care units~        -  To investigate the relation between the successful enteral feeding and mortality ,~          morbidity du to the sepsis , septic shock and multiorgan failure~      Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU~     (IFABP in PICU)~      Critically ill children are at increased risk for intestinal injury, gastrointestinal~     dysfunction and feeding intolerance, which are associated with delayed recovery and~     increased morbidity and mortality during their course in the pediatric intensive care unit.~     In critically ill children, there is little data on the factors influenced the enteral~     nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early~     intestinal damage due to these medications.~      Aim There is no information which shows that the role of the intestinal microcirculation~     problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We~     aim to reach these goals in our study~        -  To show the value of IFABP regarding the identifying feeding intolerance and early~          detection of enteral feeding intolerance~        -  To show the relation between the IFABP concentration and enteral feeding intolerance~        -  To show the relation between the mechanical ventilation settings , sedation , inotropic~          medications doses and IFABP concentration and feeding intolerance~        -  To show the relation between IFABP concentrations and mortality and morbidity due to~          the sepsis , septic shock and multi system organ failure~      Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be~     delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients~     within 48 h after PICU admission. Patients with Early Initiation of Feeding were~     statistically significant more likely to have ERTEN. ERTEN was independent significant~     prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day~     2 indicating improved survival.~   "
35037|NCT02598362|"~     Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration~     in children aged 3 months - 17 years who are treated for urinary tract infections.~   "
35038|NCT02598349|"~     The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical~     candidates is poor. Patients characterized as having borderline resectable disease treated~     with preoperative chemo-radiotherapy fair somewhat better - although many of these patients~     are not converted to resectability. It may be argued that intensification of local and~     regional therapy might 1.) Increase the share of patients able to undergo curative surgery~     and 2.) Improve the local disease control interval and extend survival for patients who~     remain unresectable. Therefore, the purpose of this research study is to determine if an~     increase in the number of surgical resection pancreatic adenocarcinoma is higher than~     historical data by using a combined treatment of proton radiation with capecitabine (oral~     chemotherapy).~   "
35039|NCT02598336|"~     Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based~     method will be compared to those obtained by spirometry using a flow based pneumotachograph~     method. This study will enable validation of SLP in children and adults by allowing direct~     comparison of simultaneous measurements of breathing sequences using the two measurement~     techniques.~      The investigators will also examine, in a group of normal adults, repeatability of the~     agreement between the two devices, and whether the agreement is affected by a change in~     tidal breathing parameters.~   "
35040|NCT02598323|"~     State of the question and research objective: International trials have shown that~     ultrasound measurement of the cervix identifies a population at high risk of preterm~     delivery. In case of short neck several types of treatments can be recommended:~     progesterone, the establishment of a strapping or pessary. These three treatments reduce the~     risk of preterm delivery. There is no French study.~      The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by~     introducing a routine ultrasound screening strategy asymptomatic short necks.~      Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA~     are eligible to ultrasound of the cervix.~        -  Primary endpoint: delivery rate before 37 weeks.~        -  Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality~          morbidity.~      Expected result: a prematurity of 50%~   "
35041|NCT02598310|"~     The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab~     for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.~   "
35042|NCT02598297|"~     Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive~     disease with increased risk of leukemic transformation and reduced overall survival. As~     there are no therapies currently established in the subset of high molecular risk patients~     with early myelofibrosis, the study aims to evaluate ruxolitinib in this patient population.~   "
35043|NCT02598284|"~     This study evaluates the ability of small primary care practices to 1) implement~     point-of-care and population management quality improvement strategies to improve~     cardiovascular quality of care (e.g., clinical decision support, patient education and~     counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance~     measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood~     pressure control, cholesterol management, and when applicable, smoking cessation) and allow~     regional benchmarking. This minimal risk study is a practice-randomized trial to determine~     a) whether point of care strategies improve ABCS performance measures compared to baseline,~     and b) whether adding locally tailored population management strategies to POC strategies~     improves performance on the ABCS measures more than POC strategies alone.~   "
35044|NCT02598271|"~     Acute kidney injury (AKI) is an infrequent but major and well - recognized complication of~     cardiac surgery. Recent studies demonstrated that even minimal increases in serum creatinine~     are associated with a rising risk of mortality, hospital length of stay, and cost.~     Furthermore a cut-off for baseline serum creatinine and its influence on mortality after~     cardiac surgery has been shown.~      In this study the investigators want to test if increased bSCr is influenced by body~     composition. Further the investigators want to determine if the incidence of AKI is~     different in patients below or above the estimated cut-off. Therefore the investigators want~     to perform a prospective cohort analysis and will take several other body composition and~     nutrition parameters to test their influence on the predictive power of bSCr. Furthermore~     the investigators want to evaluate several novel biomarkers for AKI on their predictive~     effect in cardiac surgical patients.~   "
35045|NCT02598258|"~     The purpose of this study is to determine the safety on sauna followed by cold water bath, a~     common practice in many countries, 30 healthy subjects aged 40 years and older will be at~     the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.~   "
35046|NCT02598245|"~     Transobturator tapes (TOT) are placed according to the surgical technique described by~     Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy~     (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator~     sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator~     sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After~     suturing the vaginal skin the Hegar sounds are removed.~   "
35047|NCT02598232|"~     This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system~     (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to~     alleviate back pain in a lumbar herniated intervertebral disc patient.~   "
35048|NCT02598219|"~     The aim of this study is to evaluate the sentinel node policy in early stage endometrial~     carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node~     policy to current French initial staging protocols).~   "
35049|NCT02598206|"~     The purpose of this study is to evaluate the effect of food intake on PF-04136309~     pharmacokinetics (PK) following a single dose at 1000 mg.~   "
35050|NCT02598193|"~     This clinical study will evaluate the safety and tolerability of combination treatment of~     nintedanib and pirfenidone in participants with IPF. Eligible participant must have received~     pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the~     study as a combination treatment for IPF for 24 weeks.~   "
35051|NCT02598180|"~     Vergenix Flowable Gel is indicated for the management of acute and chronic wounds~   "
35052|NCT02598167|"~     This multi-center non-interventional, observational, cross-sectional study in adult~     participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the~     participants' preferences for disease modifying treatments (DMT) in routine clinical~     practice.~   "
35053|NCT02598154|"~     The main objective of this study is to evaluate the metrological characteristics of the data~     processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement~     relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of~     a step and in the middle of the oscillating phase.~   "
35054|NCT02598141|"~     The main objective of this study was to compare the diagnostic capability (sensitivity and~     specificity) of standard bacteriological analysis made from one or other of the two sampling~     processing techniques and perioperative management of samples : the Ultra Turrax method that~     uses grinding versus the standard method.~   "
35056|NCT02598115|"~     The primary objective of this study is to evaluate the impact of the implementation of~     collaborative pharmaceutical care on drug support at admission for patients 65 years of age~     and older.~      This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to~     participating centers. A randomly selected center is crossed-over into the intervention~     every fifteen days after the start of inclusions.~   "
35057|NCT02598102|"~     Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are~     usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of~     pain during this procedure and also continue to have discomfort during voiding for few days.~     The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac~     suppository during flexible cystoscopy has been proven to be effective. This study was done~     to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent~     removal by rigid cystoscopy when compared to placebo and to assess its safety in these~     patients~   "
35058|NCT02598089|"~     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of~     subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1;~     A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and~     female adults 18 through 45 years of age will be randomized to receive vaccine (30) or~     placebo (30).~   "
35059|NCT02598076|"~     All subjects will attend an initial clinic visit with the neuropsychiatrist and~     epileptologist. At the end of this visit, those subjects randomized to motivational~     interviewing will be questioned using standardized motivational interviewing techniques by~     the study author who is a board certified neurologist and who will have formal training and~     certification in motivational interviewing.~      Those subjects randomized to the control group will also undergo an initial clinic visit~     with a neuropsychiatrist and neurologists. However they will not undergo any subsequent~     motivational interview. Following the initial clinic visit, all subjects with ongoing~     seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham~     and Women's Hospital or referred to a local psychotherapist according to their preference.~      All subjects will be contacted by phone at 3 month follow-up. If necessary they will be~     called 5 times at various times during the day and early evening. If they are not reached,~     they will receive a letter requesting them to contact the study staff to complete the study.~     Subjects will be questioned about their adherence to treatment. The primary outcome will be~     the number of psychotherapy sessions for the treatment of PNES in which they have~     participated over the past three months. They will also be assessed for secondary outcomes~     including dichotomous adherence (either seizure freedom or active participation in~     psychotherapy for the treatment of PNES, with more than 5 sessions over the past 3 months),~     seizure frequency over the past month, number of hospitalizations and emergency department~     visits over the past 3 months, and quality of life as measured by the brief QOLIE-10~     instrument. For those patients who give permission, their psychotherapists will be contacted~     by study staff to confirm the exact number of psychotherapy sessions over the past 3 months.~     A standard Partners clinical records release form with the patient's signature will be sent~     to the therapist's office.~   "
35060|NCT02598063|"~     This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in~     participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will~     be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral~     lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine~     for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target~     sample size is 255 individuals.~   "
35061|NCT02598050|"~     The purpose of this work is to determine whether preoperative cognitive screening of~     patients over the age of 65 can be used as predictor of postoperative outcomes in patients~     undergoing lower extremity surgical procedures. This work is important as it may aid~     patients, families and physicians about the appropriateness of the surgical procedure and in~     providing resources to patients who are at the highest risk of adverse outcomes.~   "
35062|NCT02598037|"~     Obesity is considered one of the most troubling chronic diseases for public health because~     of its rapid growth in the population. Many are the causal factors of this epidemic, and in~     recent years studies suggest the involvement of genetic factors in the etiology of obesity~     as a risk factor for its development. Polymorphism of the FTO gene is being studied in the~     past eight years and has been indicated as a predictor of obesity in the population, as well~     as associations in food intake, raising the possibility of influence in the regulation of~     hunger and satiety. Accordingly, researchers observed changes in levels of postprandial~     leptin and ghrelin, which can promote appetite and change the quantity and quality of food~     intake in subjects with the polymorphism FTO.~   "
35063|NCT02598024|"~     The purpose of this study is to determine whether two types of short-term trauma-focused~     therapies (individual Narrative Exposure Therapy and group-based Control-Focused Behavioural~     Treatment) are effective in the treatment of chronic PTSD in earthquake survivors of Nepal.~   "
35064|NCT02598011|"~     This is a multi-center, open label trial of combination therapy with Toca 511 and ascending~     doses of Toca FC added to the SOC for newly diagnosed HGG.~   "
35065|NCT02597998|"~     The aim of this study is to assess the mass balance recovery from excreta of carbon 14~     labelled BI409306 ([14C] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide~     plasma, urine and faecal samples for metabolite profiling and structural identification.~   "
35066|NCT02597985|"~     Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk~     elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients~     undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown~     whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes~     after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to~     improve physical performance before TAVR improves outcomes after TAVR.~   "
35067|NCT02597972|"~     Will patients who suffer complex humerus fractures have better functional outcomes and less~     implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA)~     compared to shoulder repair (open reduction and internal fixation, ORIF)?~   "
35068|NCT02597959|"~     1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on~          allied health professionals in surgical care (e.g. scrub nurses, surgical assistants,~          and circulating nurses)?~        2. Can the investigators design wearable devices that the investigators can later~          evaluate?~   "
35069|NCT02597946|"~     to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2~     mutations, previously treated with 1 or 2 chemotherapy regimens~   "
35116|NCT02597335|"~     This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining~     mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG~     detection by Brain Spectro MRI.~      In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery~     will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor~     mutational status and D-2HG.~      In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI,~     plasma, urine dosages overtime in order to correlate results with the response to treatment.~   "
35070|NCT02597933|"~     Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from~     multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the~     main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc~     and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in~     idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung~     fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of~     nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial~     will be conducted as a double blind, randomised, placebo-controlled trial with primary~     efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up~     to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of~     treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity~     (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with~     SSc-ILD.~   "
35071|NCT02597920|"~     The aim of this non-interventional study is to describe patient's perception of~     anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while~     suffering from atrial fibrillation (according to its approved indication in the approved~     dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K~     Antagonist (VKA).~   "
35072|NCT02597907|"~     The purpose of this study was to compare the antiemetic efficacy of aprepitant plus~     palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic~     cholecystectomy.~   "
35073|NCT02597894|"~     This pilot clinical trial studies targeted biopsies in determining response in patients with~     prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in~     which radioactive material sealed in needles, seeds, wires, or catheters is placed directly~     into or near a tumor). Studying tumor tissue obtained before and after treatment may help~     doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is~     repaired after it is damaged and to see if there are differences in the prostate tissue~     prior to and after starting androgen deprivation therapy.~   "
35074|NCT02597881|"~     The purpose of this study is to create an electronic registry to house phenotypic~     information from patients with achondroplasia. The initial focus of this registry will be to~     include U.S. patients with achondroplasia. Once populated, the collective data can be~     queried to pursue clinical research questions pertaining to health outcomes and treatment~     options for patients with this conditions. The registry is longitudinal in nature with the~     functionality to retrospectively enter patients' clinical data from the prenatal period up~     through the most recent encounter, with all intervening data entered in a chronologic~     fashion.~   "
35075|NCT02597868|"~     A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine~     therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after~     capecitabine-base chemotherapy.~   "
35076|NCT02597855|"~     To compare the short-term effect of intravitreal aflibercept injection between two subtypes~     of polypoidal choroidal vasculopathy~   "
35077|NCT02597842|"~     This is a single center, randomized, double-blinded, controlled clinical trial.The purpose~     of this study is to compare the effect of TEAS pretreatment with single acupoint or two~     acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic~     operation.~   "
35078|NCT02597829|"~     A prospective open label trial of adult patients with active Crohn's disease to determine if~     plasma concentrations of certolizumab pegol correlate to mucosal healing.~   "
35079|NCT02597816|"~     Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women~     with a history of recurrent miscarriage, with septate and sub-septate uterus being the most~     common anomalies in these women, Also, septate uterus is the commonest anomaly found in~     infertile women requiring assisted reproductive technology.~      Published data showed improved Cumulative pregnancy rate and live birth rate, and a~     significant reduction in Miscarriage rate in In Vitro Fertilization women after~     hysteroscopic metroplasty of both small and large septate compared to non-operated women.~      Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior~     to Hystro-salpingography for the differentiation between arcuate and septate uterus in~     infertile women scheduled for In Vitro Fertilization.~   "
35080|NCT02597803|"~     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic~     Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
35081|NCT02597790|"~     The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV~     only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk~     for cardiovascular disease. Participants will undergo non-invasive assessment of~     cardiovascular disease risk through measurements of endothelial function and blood~     biomarkers at baseline and 1 year (or 4 weeks after end of HCV treatment for those that~     undergo HCV treatment during study follow-up).~   "
35082|NCT02597777|"~     This is a randomized double-blinded study examining the effect of topical Acetyl~     Hexapeptide-8 AH8) for improving the cosmetic appearance and experience of oily skin.~   "
35083|NCT02597764|"~     Urination is a result of a complex neuro-muscular coordination which involves the action and~     arrangement of different parts of nervous systems as well as the muscular structure of the~     lower part of the urinary system. When there is an abnormal pattern in bladder and bowel~     habits without any known neuronal lesions, the condition is called bladder and bowel~     disorder (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary~     accidents to urinating much less than expected during the day.~      The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a~     beneficial basic and harmless form of treatment widely used for all children with BBD. SU~     involves explaining of the problem to the children and their parents by the doctors and~     educating them on proper voiding mechanisms, sitting, and standing positions as well as how~     and when to void.~      The purpose of this study is to explore the possibility of testing the additive~     effectiveness of Diaphragmatic Breathing exercise (DB) as an alternative and harmless~     additional treatment to SU in children with BBD.~   "
35132|NCT02597114|"~     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This study is an~     extension of a safety and dose ranging study to obtain long term safety and exposure data,~     as well as information on the biological activity of the investigational drug~   "
35084|NCT02597751|"~     Developmental coordination disorder (DCD) affects 5-6% of the school-age population,~     equating to ~400,000 children, or 1-2 students in every Canadian classroom. Children with~     DCD find it hard to learn motor skills and perform everyday activities, such as getting~     dressed, tying shoelaces, using utensils, printing, riding a bicycle, or playing sports.~     Researchers and clinicians do not know what causes DCD or why children with DCD struggle to~     learn motor skills. Using MRI, this study will increase understanding of how the brain~     differs in children with/without DCD and determine if rehabilitation can change the brain~     and improve outcomes of children with the disorder.~   "
35085|NCT02597738|"~     The purpose of this study is to further advancements in biospecimens (blood cellular free~     component, e.g., plasma, serum, tissue), in order to develop precision medicine, for lung~     cancer management and lung cancer screening (synergy with imaging). A co-clinical trial~     approach, with integrative analyses leveraging data from the treatment of genetic mouse~     models of lung cancer along with clinical samples and data from lung cancer patients, will~     be used to elucidate genomic background metrics, identify cell free DNA mutations, and~     further refine the liquid biopsy approach.~   "
35086|NCT02597725|"~     The purpose of this study is to describe the urinary morbidity as a result surgery and~     radiation therapy, in patients treated for prostate cancer.~      All the patients will undergo a Urodynamic examination to verify the grade of Urinary~     morbidity.~   "
35087|NCT02597712|"~     A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and~     effective treatment in patients with Barrett's esophagus.~   "
35088|NCT02597699|"~     The feticide is a legal and ethical obligation during a termination of pregnancy after 22~     weeks' gestation. This method raise concerns about the fetal pain, maternal complications~     and the fetopathologic analysis. There are few studies on the subject. Investigators want to~     evaluate a drug in order to facilitate this method technically and emotionally challenging.~     They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a~     optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its~     properties, it is a powerful morphine. A phase 2 clinical trial has assessed the~     feasibility, efficacy and safety of Ultiva®. They had not been able to prove bradycardia or~     lethal effect of Ultiva injected alone but the feasibility and safety were good.~      Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine~     versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary~     outcome is the interval between the vascular injection of lidocaine and fetal asystole. The~     secondary outcomes are the success rate of method, the number of puncture of the umbilical~     cord, the maternal side effects and the quality of fetopathologic analysis.~      The previous observational study showed a median interval of 2,3 minutes and a success rate~     of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions~     to 66 patients.~      They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy~     of lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to~     other fetal medicine team.~   "
35089|NCT02597686|"~     When the investigators are caught up in emotions, it is by stepping back (or decentering)~     that the investigators are able to see the situation from another perspective. Individuals~     with emotional disorders, however, can have difficulties in being able to do this.~      Research has shown that improving an individual's ability to step back from their emotions~     and take perspective is possible and can have beneficial effects on depressive~     symptomatology (Self Distancing and Perspective Broadening [SDPB] training). The SDPB~     training package involves two techniques: 1) stepping back from situations using mental~     imagery (building a mental picture of the situation and changing the distance to it) and, 2)~     reframing situations using perspective broadening reappraisals (giving new meanings to~     situations). The training package trains these SDPB techniques using an individual's~     memories and every day events. The fortnightly training comprises of two one to one sessions~     and daily homework for a week in between.The SDPB training package is aimed at improving an~     individual's ability to step back from, and put a new meaning to emotional events that take~     place in their lives.~      The prospective pilot study aims to investigate whether the SDPB training package reduces~     symptomatology and improves these abilities in individuals who experience both depressive~     and manic episodes (Bipolar Disorder [BD]).~      BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with~     moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is~     considerably low compared to other mental health problems and CBT can be time time~     consuming, expensive, and cognitively demanding (requiring a high level of functioning of~     one or more cognitive functions). Accordingly, BD may be one of the emotional disorders in~     greatest need of novel and evidence based treatments.~   "
35090|NCT02597673|"~     The overall objective of this project is to compare the three home-managed treatment~     regimens for PFPS: neuromuscular electrical stimulation (NMES), transcutaneous electrical~     nerve stimulation (TENS), and NMES combined with TENS to a standard home exercise program~     (HEP). Each of the three treatment arms will be supplemented by HEP and compared to a group~     receiving standard HEP alone. The central hypothesis is that the combination of NMES with~     TENS will show significantly greater improvements in muscle strength, mobility, pain, daily~     activity and quality of life (QOL) than HEP alone.~      The investigators are examining: 1) whether the three treatment regimens are significantly~     more efficacious than standard HEP alone in improving lower extremity muscle strength,~     physical activity, mobility, pain, and quality of life; 2) lower extremity muscle strength,~     physical activity, mobility, pain, and quality of life differ significantly across the 4~     time periods; 3) is there an interaction between treatment and time in relation to lower~     extremity muscle strength, physical activity, mobility, pain, and quality of life.~   "
35091|NCT02597660|"~     Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and~     reduced function in patients. Standard treatment options for patellar tendinopathies include~     non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy,~     eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these~     therapies and return to normal activity levels, and recurrence rates for those who do~     respond are unacceptably high. Many patients who fail to respond display persistent~     degenerative changes on imaging studies suggesting a failure to regenerate the pathological~     tissue. Developing new therapies that can directly promote the synthesis of new, healthy~     extracellular matrix tissue could therefore address an important therapeutic need and make a~     substantial improvement in our ability to effectively treat patellar tendinopathy and reduce~     recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown~     to increase protein synthesis and matrix production when delivered directly into the tendon.~     This study will evaluate the ability of somatropin to improve clinical outcomes and tissue~     quality in patients with chronic tendinopathy.~   "
36300|NCT02581865|"~     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of~     NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will~     enroll approximately 90 male and female subjects clinically diagnosed with Tourette~     Syndrome.~   "
35092|NCT02597647|"~     This study will serve to determine how influenza infection alters the bacterial colonization~     patterns in the nasal and oropharyngeal compartments, and whether the immune response~     correlate with these alterations. The investigators will be determining bacterial~     composition and immune responses in the nose and oropharynx during influenza infection.~      Specific Aims~      Therefore, the overall aims of this study are as follows:~        1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal~          microflora and immune responses after administering intranasal live attenuated~          influenza virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;~        2. To identify nasal and oropharyngeal microbial composition and local immune responses~          during influenza infections and after resolution of infection, and correlate these~          changes with clinical outcomes.~   "
35093|NCT02597634|"~     This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled,~     parallel-group study designed to determine the efficacy and safety of SST-0225 (5.4 grams,~     applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain~     associated with DOMS.~   "
35094|NCT02597621|"~     Multi-center, observational, prospective cohort study including patients with~     multidrug-resistant tuberculosis at different sites in Germany.~      The aim the study is the identification of biomarkers for therapy response.~   "
35095|NCT02597608|"~     This is a randomized study in three areas of Bangladesh (Chars region where CLP operates,~     Haor region where Shiree operates, and urban slums where UPPR operates). Treatment is~     assigned at the community level, where treatments are:~        -  Livelihoods intervention only (L only)~        -  Livelihoods intervention plus nutrition intervention (L+N)~      In UPPR only, the study also includes a non-randomly selected comparison group (C).~      Within treatment localities, targeted beneficiaries include women, adolescent girls, and~     children under 24 months. Benefits are received for two years.~   "
35096|NCT02597595|"~     The aim of this study is to evaluate the cardioprotective effect of spirulina in children~     with beta thalassemia.~   "
35097|NCT02597582|"~     The aim of this prospective randomized study was to investigate if the LigaSure vessel~     sealing system can reduce the operation duration and the postoperative drainage amount in~     patients undergoing neck dissection.~   "
35098|NCT02597569|"~     Patients with cognitive impairments following a stroke are often denied access to inpatient~     rehabilitation, despite evidence of its benefits for them. Patients with cognitive~     impairment who are admitted to inpatient stroke rehabilitation often receive services based~     on outdated impairment-reduction models, rather than recommended function-based approaches.~     These two issues, reduced access to rehabilitation and the knowledge-to-practice gap, both~     stem from a reported lack of skills and knowledge on the part of some stroke rehabilitation~     teams to foster recovery in people with cognitive impairments. To address these issues, the~     investigators will implement and evaluate a multi-faceted, supported, integrated knowledge~     translation initiative, targeted specifically at the inter-professional application of the~     Cognitive Orientation to daily Occupational Performance (CO-OP), called CO-OP KT. CO-OP is a~     contemporary, effective, cognitive strategy-based treatment approach. CO-OP KT is a~     combination of the CO-OP Approach with multi-faceted knowledge translation support. Clinical~     staff at participating institutions will receive CO-OP KT training.~      The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with~     stroke and cognitive impairments. Three specific research questions have been posed, one of~     which is the focus of this registration. That sub study relates to patient outcomes~     following the CO-OP KT training initiative and it will be addressed using a non-randomized~     design with historical controls. Patient participants who enroll in the project prior to~     implementing the CO-OP KT training will belong to the historical control group. Patient~     participants who enroll in the project after the CO-OP KT training will belong to the CO-OP~     KT Exposure group.~   "
35099|NCT02597556|"~     Cheap and effective drugs called 'anthelmintics' are routinely administered to children in~     developing countries to eliminate infections by parasitic helminths. However, the effects of~     anthelmintic treatment on other pathogens (e.g., bacteria, viruses, protozoa) remain~     unknown. The aim of this study is to investigate the impact of anthelmintic treatment on the~     incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam.~     Diarrheal disease remains a substantial cause of morbidity and mortality in children in~     Vietnam, and these children are typically co-infected with intestinal helminths. As~     helminths and diarrheal pathogens infect the same intestinal niche, anthelmintic treatments~     may alter host immune responses and the composition of the gut microbiota in ways that~     affect infection and disease risks caused by diarrheal pathogens.~      This study will recruit 350 helminth-infected and 350 helminth-uninfected children aged 6-15~     years. Recruited children will be randomized to receive either anthelmintic or placebo~     treatment once every three months and will be monitored for incidences of diarrheal disease~     for 12 months. At the 12-month time point, all children will receive anthelmintic treatment.~     Blood and stool samples will be collected throughout the study and used for evaluation of~     anemia and host immune responses, and for classification of gut microbes and parasite~     detection, respectively. The interventional study proposed here will provide an important~     first test of whether anthelmintic treatments have any indirect effects on infections caused~     by diarrheal pathogens.~   "
35100|NCT02597543|"~     The investigators will use cardiac MRI to measure the myocardial perfusion reserve and~     amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific~     allograft dysfunction in contrast to those with normal graft function. The investigators~     hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased~     myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to~     those with normal graft function.~   "
35101|NCT02597530|"~     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS)~     combined with general anesthetic during peri-operative could alleviate the dosage of~     anesthetic drugs compared with control and sham group.~   "
35184|NCT02596412|"~     Children with cerebral palsy may benefit from treatment with botulinum toxin injections to~     decrease spasticity for improve function and quality of life. These injections cause~     repeated pain throughout childhood and may be the cause of post-traumatic stress despite~     drug and non-drug pain management. The Mini-Docs project of the French Red Cross has a~     module based on a digital device with augmented reality. Distracting the child, the use of~     this module on a tablet would reduce pain felt during botulinum toxin injections.~   "
35102|NCT02597517|"~     Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However,~     conventional endoscopy is limited to detecting lesions on the basis of gross morphological~     changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically~     obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the~     risk of missed pathology and sampling errors.~      Gastric cancer is the second most common cause of cancer related death. One of the main~     roles of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage.~     The importance of identifying H. pylori infection is because it plays a very important role~     in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis,~     intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a~     precancerous gastric lesion is because we can detect most tumors at an early stage and~     improve the survival.~      Most studies conclude that it is difficult to diagnose H. pylori related gastritis and~     gastric atrophy on the basis of endoscopic findings. Histology is therefore currently~     considered to be the gold standard for detecting H. pylori infection. The reliability of~     detecting H. pylori infection histologically depends on the site, number, and size of~     gastric biopsy specimens, as well as on expertise in staining and visualizing the bacteria.~     Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling,~     and neither the original nor the revised version of the Sydney system reliably identifies~     more than half the cases in patients with confirmed gastric atrophy.~   "
35103|NCT02597504|"~     This research study will evaluate a standalone software application and is designed to~     standardize and validate new neurocognitive screening testing for children aged 6 through~     11, and adolescents and adults ages 12 through 75.~      The purpose of this study is to evaluate recently developed computerized tasks sensitive to~     changes in neurocognitive performance after a concussion. These tests were designed to help~     measure the effects of concussion on cognitive processes (e.g., memory, attention, brain~     speed) and visual functioning.~   "
35104|NCT02597491|"~     In this sequential, multiple assignment, randomized trial (SMART) current smokers who are~     eligible for lung cancer screening will be identified using the electronic medical record at~     the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8~     weeks of evidence-based first-line smoking cessation treatment. Participants will be~     eligible for three potential randomizations during one year of smoking intervention: 1) to~     timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to~     telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered~     Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim),~     and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line~     treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence~     measured 18 months after the beginning of treatment.~   "
35105|NCT02597478|"~     The goal of this clinical research study is to learn if fentanyl can help shortness of~     breath in cancer participants. Researchers also want to learn if the study drug can help to~     improve participant's physical function.~   "
35106|NCT02597465|"~     An open label study to determine the efficacy and safety of SPARC1507~   "
35107|NCT02597452|"~     The primary purpose of this study is to measure the clinical utility (accuracy) of the~     hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results~     will be compared to the results of a current mammogram and/or ultrasound. The duration of~     study participation is approximately 30 minutes one day.~   "
35108|NCT02597439|"~     The purpose of this study is to determine whether omega-3 fatty acids are effective in the~     prevention of psychosis in individuals at ultra-high risk for psychosis.~   "
35109|NCT02597426|"~     Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of~     research in head and neck radiation oncology have largely focused on improvements in~     survival, which have mostly come at the cost of long term toxicity for surviving patients.~      This is an observational study that is being done to learn about the long-term symptoms and~     side effects that survivors of nasopharyngeal cancer may have following radiation treatment.~     This study will include assessment of patient report outcomes, physician-graded adverse~     events, neurocognitive assessment and endocrine and hearing testing~   "
35110|NCT02597413|"~     The primary objective of this study is to evaluate the impact of systematic~     catheter-drainage of urine for parturient women immediately in the delivery room on the~     occurrence of post-voiding urine residue.~   "
35111|NCT02597400|"~     This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK~     activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).~   "
35112|NCT02597387|"~     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse~     large B-cell lymphoma and lymphoma peripheral T cell.~   "
35113|NCT02597374|"~     To study the reactivity of the mu rhythm during action and action-observation by EEG in~     children with unilateral cerebral injury.~   "
35114|NCT02597361|"~     This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome~     (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their~     vasculature affected by a defect in type III collagen in addition to the effects celiprolol.~     This randomized, double blind, placebo controlled trial compares the administration of the~     Ang II type I receptor blocker (ARB) — irbesartan— to placebo over a 2-year period in vEDS~     patients with the main objective to reduce the incidence of both symptomatic and~     asymptomatic vascular events.~   "
35115|NCT02597348|"~     This is a multicentric randomized parallel group open trial comparing 5-year survival of~     chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients~     with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no~     progression) and extensively explored by modern imaging techniques. The primary objective of~     the trial is to validate in a large multicentric cohort of selected patients the possibility~     to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around~     10% with chemotherapy alone.~   "
35185|NCT02596399|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study~     in healthy volunteers, enrolled at a single site in the United States to investigate the~     safety, tolerability, and pharmacokinetics of DSTA4637S.~   "
35117|NCT02597322|"~     Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial~     growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in~     phase II study in cytokine-refractory metastatic renal-cell cancer patients.~      Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with~     large organ confined tumors to benefit from NSS.~      The Objective is to determine the efficacy of Axitinib administered prior to surgery in~     patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for~     shifting from a radical nephrectomy indication to a nephron sparing procedure.~   "
35118|NCT02597309|"~     The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely~     Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients~     with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with~     U-500 insulin may result in significant reduction in insulin dose due to improved insulin~     sensitivity and weight loss.~   "
35119|NCT02597283|"~     This study is designed to test the hypothesis that the Biguard stent system will lead to~     fewer target lesion failure compared to regular stent system in patients with coronary~     bifurcation lesions at one year.~   "
35120|NCT02597270|"~     The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV)~     NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or~     previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the~     frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are~     associated with direct-acting antivirals (DAAs)-resistance.~   "
35121|NCT02597257|"~     The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the~     Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.~   "
35122|NCT02597244|"~     Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South~     Korea), was performed in patients who did not show improvement lasting more than 1 month~     after diagnostic conventional fluoroscopically guided transforaminal epidural block with~     local anesthetic and steroid.~      Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris~     Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the~     procedure.~   "
35123|NCT02597231|"~     Recent data suggests that melatonin, a supplement available over the counter, may help~     prevent delirium in hospitalized patients. The investigators are hypothesizing that~     melatonin may help in delirium prevention by improving sleep quality and possibly circadian~     rhythm cycling in patients who are given the supplement. This pilot study involves a~     randomized placebo-controlled design in which participants will be randomized to receive~     either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted~     with wireless actigraphy devices to obtain objective sleep quality, and will also receive a~     sleep questionnaire each morning to obtain subjective data on their sleep quality overnight.~     Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method~     (CAM).~   "
35124|NCT02597218|"~     Observational. Retrospective cohort.~   "
35125|NCT02597205|"~     The overarching goal of this program to increase the use of evidence-based,~     secondary-prevention medications and promote healthy lifestyles among myocardial infarction~     (MI) patients through using provider-facing mobile app and patients-facing text messages.~   "
35126|NCT02597192|"~     Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and~     Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in~     patients with generalized gingivitis.~      Materials and methods: In this double-blind placebo-controlled randomized clinical trial~     generalized gingivitis patients who were systemically healthy and who did not smoke were~     included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8~     weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary~     outcome measures were pocket probing depth and bleeding on probing.~   "
35127|NCT02597179|"~     The purpose of this study is to investigate and analyse genomic profiles in patient with~     breast cancer who failed standard treatment, refractory and young breast cancer.~   "
35128|NCT02597166|"~     There are now several licensed drug treatments for patients with HCV infection. These~     medications have been shown to be very effective in getting rid of the virus in patients~     with HCV infection including those with early stages of cirrhosis without complications~     known as compensated cirrhosis, with a greater than 90% cure rate. At present, there are~     very little data to show that treating patients with HCV infection and decompensated~     cirrhosis will give the same effects. However, patients with decompensated cirrhosis as a~     result of hepatitis B infection who received treatment to control their virus show~     improvement of their overall liver condition, and the liver complications of many of these~     patients disappeared. Also, patients with cirrhosis due to excess alcohol and who stopped~     drinking also showed improvement in liver function and their complications of cirrhosis~     coming under control. Therefore, treatment of patients with HCV infection and decompensated~     cirrhosis is expected to show the same positive effects, because the underlying cause of~     cirrhosis is coming under control. Harvoni is a combination of two direct-acting antivirals~     (ledipasvir and sofosbuvir) that prevents the hepatitis C virus from copying and multiplying~     themselves, allowing the body to clear the virus from their systems and be cured of HCV~     infection. This study is being conducted to find out if treatment with Harvoni will lead to~     clearance of HCV infection in patients with decompensated cirrhosis giving rise to~     improvement in liver function, together with improvement of quality of life and survival.~   "
35129|NCT02597153|"~     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with~     relapsed cutaneous T cell lymphomasell~   "
35130|NCT02597140|"~     The purpose of this randomized pilot study is to evaluate the effect of intravenous~     lidocaine on propofol requirement during BIS (Bispectral index) guided MAC (monitored~     anesthesia care) in facial plastic surgery.~   "
35131|NCT02597127|"~     This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 subjects~     with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (eg, diabetes~     and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of~     LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of ALN PCSSC~     injection(s).~   "
35133|NCT02597101|"~     The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism~     in general represent important gaps in knowledge to better understand the etiopathogenesis~     of T2D. Emerging evidence indicates that certain leukocyte populations serve as an important~     nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the~     efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in~     improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This~     trial also offers a first-in-kind opportunity to better understand the role of specific~     leukocyte populations in type 2 diabetes. The drug's clinical profile suggests that it will~     be well-tolerated with few, if any, side effects, and the existence of simple methods that~     can indirectly measure its activity in vivo~   "
35134|NCT02597088|"~     Human milk (HM) is more than a food complex; in addition to micronutrients and human-coded~     bioactive complexes it also includes many antioxidants, antibacterial, prebiotics,~     probiotics, immune-boosting constituents, and many other bioactive components. Some of these~     components may deteriorate during storage, and expressed EHM starts deteriorating as soon as~     it leaves the breast. Nevertheless, whenever nursing at the breast or feeding of fresh EHM~     is not possible, feeding of stored EHM is considered the next best thing to feeding at the~     breast. Efficient heat transfer abilities affect both heating and cooling processes.~      In this study the investigators wish to test a new device that permits rapid heating and~     cooling processes. The investigators plan to measure some thermolabile constituents of HM in~     order to determine whether they might be protected by a more gentle warming process. The~     investigators plan to collect milk from mother, to mix it and to test the effect of storage~     and heating.~      This experiment is design to test the feasibility and the efficiency of the device.~   "
35135|NCT02597075|"~     The purpose of this study is to assess whether a structured physical activity program (PA)~     during palliative chemotherapy improves progression-free survival (PFS) and/or~     patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.~   "
35136|NCT02597062|"~     The purpose of this study is to find out what effects carfilzomib has on relapsed multiple~     myeloma when administered in combination with cyclophosphamide and dexamethasone.~   "
35137|NCT02597049|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in~     participants with type 2 diabetes mellitus.~   "
35138|NCT02597036|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3127804 given as monotherapy and in combination with Ramucirumab for participants with~     advanced or metastatic solid tumors. The study will also include a safety exploration for~     the combination of LY3127804 plus ramucirumab and paclitaxel~   "
35139|NCT02597023|"~     The purpose of this study is to assess the efficacy of supplementation with the~     mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function~     (vascular, motor, and cognitive) in middle-aged and older adults.~   "
35140|NCT02597010|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic~     blood pressure in multiple populations including newly diagnosed, untreated hypertensives.~     The additional effect in hypertensives on blood pressure lowering medications is uncertain.~   "
35141|NCT02596997|"~     Provide patients with serious AdV infection or disease access to treatment with BCV.~   "
35142|NCT02596984|"~     Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and~     patients, only a few studies have been performed in critically-ill patients. In these~     patients several factors, including sepsis, shock, increased distribution volume, hepatic~     dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations~     and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from~     case series or animal studies. Thus, studies performed so far show Caspofungin trough~     concentrations either decreased, similar to usual value in non-critically ill patients or~     increased. One of these studies suggested that body weight and hypoalbuminemia may be the~     main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic~     parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of~     distribution of caspofungin and intercompartmental clearance to be higher than in healthy~     animals. These results are however preliminary and cannot be extrapolated suggesting further~     clinical studies in human to be needed.~      The primary objective of this study is to assess Caspofungin trough concentrations and~     pharmacokinetics in critically-ill patients requiring vasopressors.~   "
35143|NCT02596971|"~     This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety,~     efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in~     combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP~     (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy~     (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting~     of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a~     complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab~     alone in participants with DLBCL who achieve a CR at EOI.~   "
35144|NCT02596958|"~     The purpose of this non-interventional study is the collection and documentation of data on~     safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based~     chemotherapy for first-line treatment in participants with unresectable advanced, metastatic~     or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell~     histology with focus on adenocarcinoma and elderly patients in daily routine.~   "
35145|NCT02596945|"~     This non-interventional, observational study investigates the efficacy, safety and usability~     of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis.~     Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor~     and who meet the selection criteria were to be enrolled and documented in this study for a~     period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect~     to efficacy, safety and usability.~   "
35269|NCT02595307|"~     To determine if providing a written document in addition to the standard oral discussion of~     surgical risks improves risk recall for the parents/guardians of a child seen in~     consultation for cleft palate surgery, and if this has any effect on overall satisfaction~     after the procedure~   "
35146|NCT02596932|"~     Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of~     pregnancy. Neonatal hypoglycemia is a common and well described complication for infants~     born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum~     maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide~     practitioners in how to best manage intrapartum maternal glucose levels among Type I and and~     Type II DM, there is a paucity of data guiding practitioners in the intrapartum management~     of blood glucose levels for women with GDM, particularly those treated with insulin~     antepartum. The goal of this project is to compare two protocols of intrapartum glucose~     management in women with GDM and investigate the impact on neonatal blood glucose levels.~   "
35147|NCT02596919|"~     Infrared meibography is a useful technique in the evaluation of meibomian gland disease~     (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen~     in the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including~     tear film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct~     visualization of meibomian glands by infrared meibography has been shown to correlate well~     with these parameters.~      Although infrared meibography was developed more than 30 years ago, it is not widely used.~     This has probably been due to the need for special equipment, examiner time and expertise~     and patient discomfort during the examination. Analysis of the acquired images also needed~     to be from video review with extraction of video stills - a time-consuming process.~      Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared~     images of meibomian glands using equipment already available at QVH. This pilot study will~     validate the technique and check patient acceptability. Investigators are hopeful this test~     could be used as a useful tool for future research into dry eye conditions and MGD.~   "
35148|NCT02596906|"~     Individuals aged 55 and older may experience negative effects of cognitive decline. The~     proposed research seeks to evaluate the benefits of different types of interventions:~     reasoning training following transcranial direct current stimulation (tDCS) and reasoning~     training following sham transcranial direct current stimulation (tDCS) on frontal- lobe~     mediated cognitive measures of executive control in adults with memory complaints, in the~     absence of dementia.~   "
35149|NCT02596893|"~     The purpose of study is to test the effects of an experimental medication GED-0301~     (mongersen) in patients who have active Crohn's disease. The study will test GED-0301~     compared to placebo for 52 weeks. The study treatment is blinded which means that patients~     and the study doctor will not know which treatment has been assigned. Patients in this study~     will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,~     immunosupressants and antibiotics for the treatment of Crohn's disease.~      After 12 weeks in the study until the end of the study, patients who do not have an~     improvement in their Crohns disease symptoms will have the option to enter a long term~     active treatment study.~   "
35150|NCT02596880|"~     The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir~     400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200~     mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral~     response rate at 12 weeks.~   "
35151|NCT02596867|"~     This trial is a Phase II study using the window-of-opportunity design in which the~     treatment-free window between breast cancer diagnosis and surgical tumor resection is used~     to study the biological effects of the beta blocker propranolol .~   "
35152|NCT02596841|"~     The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography~     (CT) imaging, whereas lung function studies are used for staging and follow up. Lung~     diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated~     with the severity of CT-determined fibrotic process. A possible explanation of this finding~     is that DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance~     (DMCO). Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with~     CT-determined amount of fibrosis/honeycombing in both usual and non-specific interstitial~     pneumonias. Moreover. Both DLNO and DMCO were below the lower limit of normality even in~     patients with small amount of fibrosis. Measurement of DLNO may provide a more reliable~     assessment of fibrotic changes than DLCO because it better reflects DMCO.~   "
35153|NCT02596828|"~     Children, adolescents and young adults with relapsed or treatment refractory pineoblastoma~     (rPB) represent a group of patients with dismal prognosis for whom a recommended standard~     salvage therapy is currently not available.~   "
35154|NCT02596815|"~     The purpose of these study is to compare the effectivity of the Median Nerve Neural~     Mobilization technique to the complete absence of treatment in a group of patients who~     suffer cervicobrachial pain.~   "
35155|NCT02596802|"~     The goal is to study the feasibility and safety of implementing Fetoscopic Endoluminal~     Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic~     Hernia (CDH). The pilot study will determine whether FETO therapy can be performed safely~     and whether it can increase survival and decrease morbidity when compared to standard~     prenatal care for the treatment of severe left CDH.~   "
35156|NCT02596789|"~     This study has two main goals :~        -  to investigate the impact of aging on cortical excitability (CE)~        -  to investigate the impact of state dependency on CE, using a cognitive task and an~          emotional one.~      A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic~     response are recorded.~   "
35157|NCT02596776|"~     An adaptation to a cold environment is a tendency to generate heat within our body. Some of~     this heat comes from our fat tissue. Although most fat tissue is white fat, there are~     pockets deep within the body that are called brown fat, which are specially adapted to~     burning fat and making heat. The investigator believes that our white fat, just underneath~     the surface of our skin, also has this property to burn fat and make heat, although not at~     the high level of brown fat. This study is to examine this fat-burning property of the white~     fat under the skin in response to seasons and to cold. Many such studies have been done in~     mice, but little has been done in humans.~      There are a number of factors, including age, weight, and medical history, that may make a~     person eligible or ineligible to participate in this study. Certain medications could make a~     person ineligible, but if these medications can be safely altered, the individual may become~     eligible.~   "
35158|NCT02596763|"~     BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions~     (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring~     of 792 patients during their first year of baclofen prescription for alcohol use disorder.~      The main objective of the study is to determine the rate of patients who stop baclofen due~     to an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to~     determine which types of AEs and serious AEs are actually liable to baclofen, and which~     other types are more likely the consequence of confounding factors, e.g., concomitant~     alcohol, psychotropic medications or substance uses, and comorbidities.~   "
35159|NCT02596750|"~     This study evaluates the role of microneedle pretreatment in the speed at which anesthesia~     develops after application of topical 4% lidocaine.~   "
35160|NCT02596737|"~     Individuals spend one third of their life working. Age of retirement is regularly pushed~     back. The main challenge in the nearest future will be to maintain workers health to deal~     with their work till retirement. Morbidity before retirement has a huge cost, both in public~     health and economically for companies. Numerous factors increase morbidity such as stress at~     work, sedentary and low physical activity, and poor nutrition habits. Nowadays, digital~     world wildly invades lives and offer a no-limit possibility to interact with individuals,~     everywhere. Thus, a software able to understand an individual in its globality seems to~     address this challenge. Moreover, managers need to understand the actions needed within~     their company. The objective of WittyFit is to increase life expectancy and well-being.~     WittyFit will constitute a powerful database to build strong evidence and new knowledge on~     the relationships between work, behavior, and health, based on a large amount of~     epidemiological data.~   "
35161|NCT02596724|"~     Prospective observational registry that links results of the genomic and other molecular~     testing to treatment response and survival measures in patients who have been diagnosed with~     breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests~     impact treatment decisions and outcomes.~   "
35162|NCT02596711|"~     The goal of this research study is to learn how 3 different kinds of counseling treatments~     may help individuals to quit smoking.~   "
35163|NCT02596698|"~     This study consists of three separate appointments including a clinical assessment~     (interview and questionnaires), a blood draw, a social stress test, and a brain MRI.~   "
35164|NCT02596685|"~     This randomized pilot clinical trial studies the effects of electronic cigarettes on the~     lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and~     Drug Administration (FDA) and other government regulators with important information, which~     may help in developing future regulations to make electronic cigarettes safer.~   "
35165|NCT02596672|"~     The multi-level 12 week peer-led walking intervention incorporates aspects from all three~     levels of the ecological model (with the aim of producing sustained (>6months) physical~     activity behaviour change in older adults living in independent living communities.~   "
35166|NCT02596659|"~     Background:~      Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion~     site of common extensor tendon to humerus. It is usually related to overuse of local muscle.~     Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It~     applies shockwave energy to the lesion site, enhancing the growth of microvascularity,~     inducing tissue repair, and thus relieving the symptom.~      The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.~      Material and Methods~        -  Subjects: 30 patients will be recruited from outpatient department of physical medicine~          and rehabilitation department.~        -  Duration: 2013.09.01-2015.05.31~        -  Methods: The patients will be randomly divided into the experimental group and the~          control group through the draw, with 15 patients in each group. Patients in the~          experimental group receive rESWT plus routine rehabilitation program. Patients in the~          control group receive sham shockwave therapy plus routine rehabilitation program.~        -  Assessment: Before the therapy starts, patients who match the inclusion criteria will~          be evaluated using tools mentioned below:~        -  General data: age, sex, body height, body weight, affected side, medical history~        -  Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and~          Hand Questionnaire (DASH)~        -  Assess severity of pain with Visual Analogue Scale (VAS)~        -  Assess grip strength with grip strength dynamometer~        -  Measure the size of tear (if any) of common extensor tendon through ultrasonography,~          and assess the texture of common extensor tendon through real-time sonoelastography~          (RTS)~      Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will~     be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and~     presentation on ultrasonography and RTS.~   "
35167|NCT02596646|"~     This study evaluates whether an early precut strategy in cases of difficult biliary~     cannulation could reduce the incidence of PEP compared with that after prolonged cannulation~     attempts. Secondary aims are to compare the success of biliary cannulation and complications~     rates of the two techniques.~   "
35168|NCT02596633|"~     This study will investigate the feasibility of running a randomised controlled trial (RCT)~     of a psychotherapy called Acceptance and Commitment Therapy (ACT), delivered in a~     self-help format with additional telephone support from a therapist, for people with~     Multiple Sclerosis (MS) and low mood.~   "
35169|NCT02596620|"~     Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative~     second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth~     salts are not available. The investigators compare the efficacies of 10-day~     levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for~     patients after failure of standard triple therapy and to determine what clinical and~     bacterial factors influencing the efficacy of salvage regimens.~   "
35170|NCT02596607|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. However, only a small percentage of patients access to thrombolysis on~     time. Various actions have been implemented since 2006 in the Rhone area as part of research~     projects and of the 2010-2014 national stroke action plan: training of health professionals~     involved in the stroke management, increase of public awareness through sensibilization~     campaigns, implementation of telemedicine and increase of the number of hospital beds~     dedicated to stroke (stroke units beds).~      The main objective of the STROKE 69 study is to assess the impact of these actions on~     intra-hospital acute stroke management times in the Rhône area. The secondary objectives are~     to assess the impact of these actions on the rate and place of thrombolysis, the rate of~     post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at~     3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number~     of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and~     management channels.~      The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016~     and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort~     study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and~     06/06/2007, before the implementation of the actions in the Rhône area.~      The cohort will be constituted of all consecutive patients treated for a stroke suspicion by~     the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area,~     and presenting a symptom-onset (the last time the patient was seen without deficit) less~     than 24 hours.~      After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or~     transient ischemic attack (TIA) will be followed for 12 months after their inclusion by~     telephone calls at 3 and 12 months to assess the level of disability and mortality.~      AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan~     to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed~     strokes or TIAs.~   "
35171|NCT02596594|"~     Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and~     long term neurological deficits. The mean interval from diagnosis of brain sparing of severe~     IUGR fetuses to delivery has been recently identified by only seven days (Flood K et al, Am~     J Obstetrics and Gynecology 2014).~      The critical placental player in the active amino acids (AA) transport from the mother to~     the fetus is the trophoblast, which is irreversibly changed in severe IUGR fetuses caused by~     placental insufficiency. Thus, a logical partial solution of IUGR could be the direct supply~     of AAs and glucose to the fetus, in order to improve the fetal growth, normalize the fetal~     programming and to prolong the pregnancy.~      The aim of this prospective pilot study is to further test the efficacy of the~     administration of AAs and glucose supplementation with hyperbaric oxygenation (HBO), via a~     subcutaneously implanted intraumbilical perinatal port system, as a treatment option for~     severe IUGR human fetuses with brain sparing.~   "
35172|NCT02596581|"~     The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin~     and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in~     periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes~     mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the~     GCF chemerin levels.~   "
35173|NCT02596568|"~     This study will attempt to use a type of non-invasive brain stimulation technology during~     sleep to improve measures of sleep quality and memory in young healthy students and older~     adults. The type of brain stimulation is called transcranial direct current stimulation~     (tDCS), which uses small currents of electricity to increase or decrease the activity of~     specific areas of the brain.~   "
35174|NCT02596555|"~     This prospective, multicenter, multinational, phase IV, interventional single-armed~     (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral~     anticoagulant in the treatment of patients with acute intermediate-risk PE based on~     validated imaging (echocardiographic or CT angiographic) and laboratory biomarker~     (circulating levels of cardiac troponins and natriuretic peptides) parameters and their~     combinations.~   "
35175|NCT02596542|"~     Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise~     recovery in both recreational as well as professional athletes. However, the effect of~     repeated post-exercise CWI on other recovery strategies remains unclear.~   "
35176|NCT02596529|"~     The optimal treatment of ankle fractures with involvement of the posterior malleolus remains~     a subject of debate. Despite a large amount of literature on the role of the posterior~     malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its~     treatment. Its size is the leading indication whether fixation of the fragment is necessary~     or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger~     than 25% to 33% an indication for fixation. Interestingly, after careful evaluation of the~     available literature, there does not seem to be hard evidence for these numbers. It is~     generally accepted that restoration of a normal anatomic mortise and normal tibiotalar~     contact area are key elements for a good functional outcome. Inadequate reduction of the~     posterior fragment may alter the tibiotalar contact area and the joint biomechanics with~     altered stresses in parts of the joint, leading to the development of osteoarthritis and~     worse functional outcome. Traditionally, reduction of these larger fragments is indirectly,~     followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are~     that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments~     is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral~     approach in prone position, followed by open reduction and fixation with screws in~     posterior-anterior direction or antiglide plate is advocated by several authors. This~     approach allows perfect visualization of the fracture, articular anatomical reduction, and~     strong fixation. Another advantage is that even small posterior fragments can be addressed.~     Several case series are published, which describe minimal major wound complications, good~     functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we~     perform an open, anatomical reduction and fixation of all medium-sized posterior fragments~     via this approach. Although not thoroughly investigated yet, it seems to lead to better~     clinical outcomes than described in the literature and our retrospective cohort study.~   "
35177|NCT02596516|"~     The aim of this study is to evaluate whether there is a difference in the bile acid content~     in the bowel in patients after right versus left colectomy. There is compelling evidence~     that patients under going resection of the right colon versus left coolon have a lower polyp~     detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of~     patients undergoing left and right colectomies; prior to their surgery and again three and~     six months aftet the surgery. The investigators plan to compare the content of the different~     bile acids and to compare the content between the two groups.~   "
35178|NCT02596503|"~     This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of~     eribulin in combination with fixed doses of oral irinotecan in adolescents and young adults~     with relapsed or refractory solid tumors. Eribulin will be administered intravenously on~     days 1 and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5.~      Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase~     I design, and there will be no intrapatient dose escalation. Once the RP2D has been~     established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence~     of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.~   "
35179|NCT02596490|"~     Objectives:~      Our specific aims are to:~      Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with~     metastatic lung cancer and their partners.~      Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and~     their partners regarding physical, psychological, and spiritual quality of life outcomes.~      Exploratory Aim: Explore potential intervention mediators (i.e., mindfulness, compassion,~     holding back, and intimacy) and a moderator (i.e., baseline distress) of the intervention~     effects.~   "
35180|NCT02596477|"~     The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical~     marker and functional benefit to damaged heart muscle cells. This will be evaluated by~     measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In~     addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure~     will be evaluated.~   "
35181|NCT02596451|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site~     Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1%~     (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis~     Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee~   "
35182|NCT02596438|"~     The Thousand Asian American Study or TAAS aims to test 2,000 foreign-born and children~     of foreign born Asian Americans residing in Sacramento county residents for HBV and (2)~     counsel at least 90% of those whose screening results are positive for HBV.~   "
35183|NCT02596425|"~     The aim of this clinical trial is to evaluate the efficacy and safety of different~     recruitment maneuvers for reducing postlaparoscopic shoulder pain.~   "
35186|NCT02596386|"~     Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day~     gap during the weekend. After this gap and before the first dialysis of the week the serum~     Potassium level is expected to be maximal.~      Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The~     research team would personally meet the patients who answer inclusion criteria f and ask~     whether they wish to participate.~      Each willing participant will undergo Sialometry and blood will be drawn from the dialysis~     connections for CBC and Biochemistry to establish a baseline.~      The study measurements namely Sialometry and collection of Saliva as well as blood test will~     be taken before the initiation of the dialysis.~      Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis~     will be done in the research lab of Prof. Doron Aframian.~   "
35187|NCT02596373|"~     The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone~     Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or~     metastatic breast cancer~   "
35188|NCT02596360|"~     The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in~     healthy volunteers compared to placebo.~   "
35189|NCT02596347|"~     Current studies suggest that alveolar macrophages (AM) act as silencers of most immune~     responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity~     pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion~     of the immune response in the target organ. The Investigator has preliminary data~     demonstrating that CBD AMs at the site of disease involvement (bronchoalveolar lavage, BAL)~     display an activated cell surface phenotype compared to AMs from healthy controls.~     Furthermore, exciting data from our group demonstrates significant differences in gene~     expression profiles between CBD and Beryllium Sensitivity (BeS) bronchial alveolar lavage~     (BAL) cells, in pivotal immune response genes and networks. Specifically, the Investigator~     has found the JAK/STAT pathway and the JAK2 gene was dramatically overexpressed in CBD BAL~     cells. In addition, constitutively phosphorylated JAK2 (pJAK2) was found in AMs from Chronic~     Beryllium Disease (CBD) patients by Westernblot and was increased after beryllium (Be)~     stimulation for 30 min. Moreover, the JAK2 inhibitor TG101348 significantly inhibited~     Be-induced CBD AMs TNFa and IFNy production. Meanwhile, overexpression of the JAK2 inhibitor~     SOCS 1 (suppressors of cytokine signaling) protein decreased Be-induced TNFa production from~     AMs. Based on this information, the Investigator hypothesizes that CBD AMs overexpress JAK2,~     which augments the immune response to Be and development of CBD but not BeS.~      The investigators believe that these studies are highly innovative since they will~     undoubtedly shed light on exposure-mediated immune dysregulation in Alveolar Macrophages~     (AMs) that lead to disease development and likely progression and with additional study of~     this pathway will reveal potential biomarkers for clinical prognosis and diagnosis. The~     results obtained from this study will improve the investigators understanding of factors~     involved in the development of Chronic Beryllium disease (CBD), as well as define targets~     for therapy, and will serve as a model of other exposure-related immune responses and~     environmentally-induced chronic diseases. Most importantly, these studies will provide the~     investigator with preliminary data to submit a high quality R01, allowing the Investigator~     to apply similar approaches to other genes, define a potential target for this and other~     similar immune-mediated diseases and continue research efforts at National Jewish Health~     (NJH.)~   "
35190|NCT02596334|"~     Triple antiretroviral regimens have greatly improved the prognosis of patients living with~     HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have~     a life expectancy close or equal to that of people not infected with HIV.[1] However, this~     is under the condition of a lifetime maintenance of an undetectable plasma viral load~     (pVL) (<50 cp/ml). On the other hand it is well established that aging increases~     comorbidities among PLHIV and the burden of co-medications.[2] This also has the consequence~     of frequent drug-drug interactions. In this context it is important to decrease pills~     burden, side-effects and drug-drug interactions, while maintaining undetectability.~      Currently, there is a strong interest for medical research to validate lightened regimens~     (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy,~     with the primary objective of reducing burden of pills and side effects. Several monotherapy~     trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression,~     even if this proportion was not always non-inferior to maintaining a triple therapy. [8,9]~     Fortunately, when virological failure occurred under monotherapy virologic suppression was~     easily restored by the addition of two NRTI. Patients who are most likely to maintain viral~     suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no~     previous AIDS event and a sustained virologic suppression (>12 months).~      Monotherapy is the option that best reduces the burden of pills and the risk of side effects~     or drug-drug interactions. It must be considered using very powerful molecule that harbor a~     strong binding to its ligand in order to minimize the risk of selecting resistant mutants in~     the case of virologic failure. To be as simple as possible in its use, it must be a single~     agent administered as a single dose once a day and not boosted if possible. The molecule~     must have very good tolerance. Finally, to be effective in viral sanctuaries this molecule~     should have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains.~     Dolutegravir meets all these exigences.[10] In addition, our team recently presented results~     of a pilot study showing that the switch of a successful combined antiretroviral regimen to~     dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7~     months (range 6.5-10 months).~   "
35191|NCT02596321|"~     To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as~     change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with~     ALK HDM tablets given once daily over 60 days.~   "
35192|NCT02596308|"~     Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis.~     Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history~     for plague as an agent of biowarfare, and poses a serious threat to international security.~     Althought the killed whole-cell plague vaccine and live attenuated vaccine have been~     licensed, they are rarely used today because of toxicities, limited evidence for efficacy to~     prevent plague, and limited commercial availability. In the last twenty years,the~     recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated~     (V)antigens as the main composition have caused widely attention with providing greater~     protection than vaccines comprised of either subunit alone. This study was aimed to explor~     the safety and immunogenicity of a new type plague subunit vaccine which comprised natural~     F1 antigen and recombined V antigen (F1+rV).~   "
35193|NCT02596295|"~     The study will collect human milk from 100 mother of term infants 2-3m after delivery and~     from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be~     analysed and statistical analysis will look at correlation between demographics, dietary~     habits and milk composition.~   "
35194|NCT02596282|"~     Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and~     Southern African countries, and the long-term sustainability of MMC programs could best be~     achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of~     EIMC provided by non-physicians is unknown.~      Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained~     clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda.~     501 healthy neonates aged 1-28 days with normal birth weight and gestational age were~     randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days.~     Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local~     Anesthetics (EMLA) cream and a 24% sucrose solution.~   "
35270|NCT02595294|"~     The purpose of these study is to compare the effectivity of the Cervical Lateral Glide~     physical therapy neural mobilization technique to the complete absence of treatment in a~     group of patients who suffer cervicobrachial pain.~   "
35195|NCT02596269|"~     BACKGROUND : There has been increasing interest on the use of nefopam in i.v.~     patient-controlled analgesia (PCA).~      OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when~     administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated~     with its use were also evaluated, and specific considerations in its clinical use were~     reviewed.~      DESIGN : A randomized, controlled, single-centre, double-blinded study.~      SETTING : One Korean university hospital.~      PATIENTS : Seventy-one patients planned for elective open laparotomy~      INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA~     with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included~     (fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively.~      MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient~     satisfaction at the end of the study were evaluated. Adverse events were observed.~   "
35196|NCT02596256|"~     Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric~     cancer.~   "
35197|NCT02596243|"~     The purpose of this study is to access the efficacy and safety of GX-188E according the~     protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)~   "
35198|NCT02596230|"~     RE-COVERY is a large, multi-national, multi-center observational study based on new data~     collection. The study will enroll and characterize patients within 30 days of being~     diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will~     characterize the DVT / PE patient population. All patients with a DVT and/or PE will be~     enrolled for cross-sectional characterization of the VTE patient population. Objective 2~     will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of~     VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be~     followed up for the occurrence of outcome events for up to one year.~   "
35199|NCT02596217|"~     Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066~     (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.~   "
35200|NCT02596204|"~     With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic~     for frequent and timely monitoring is now feasible. The investigators propose to leverage~     this new technology to provide children and families with appropriate interventions to help~     manage their diabetes.~   "
35201|NCT02596191|"~     This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to~     identify markers allowing to better understand the phenotypic variability observed on~     patients with CMT1A, to identify predictive markers of the disease's progression and to~     provide validated measurement tools that can be used as outcome measures in future clinical~     trials.~   "
35202|NCT02596178|"~     Lung units that participate in gas exchange are known as 'recruited' lung. Patients with~     lung injury suffer from a proportion of units that do not participate in gas exchange (i.e.~     the derecruited lung), which results in impaired gas exchange and induces an inflammatory~     cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to~     FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered~     equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement,~     the other using a higher PEEP level.~      The primary purpose of this study is to demonstrate the safety and efficacy of an electrical~     impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in~     children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A~     safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit)~     and Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in~     lung volume as assessed by electrical impedance tomography, lung compliance and by an~     improvement in markers of gas exchange. Safety will be defined as the incidence of~     barotrauma and hemodynamic consequences that occur during the protocol. Those results will~     be compared to incidences of barotrauma and hemodynamic compromise within the ARDS~     literature. Knowledge gained from this pilot will be instrumental in developing an EIT~     imagine guided protocol which will allow us to conduct future RCTs utilizing EIT technology~   "
35203|NCT02596165|"~     The significance of parameters of the central hemodynamic is based upon their strong~     association with left ventricular hypertrophy and target organ damage at the heart.~     Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the~     central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate~     highly promising potential for research and daily clinical praxis for improved~     cardiovascular risk assessment on the population level. The purpose of this study is to~     evaluate the validity of the central and peripheral blood pressure and central arterial~     stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar,~     Switzerland).~   "
35204|NCT02596152|"~     The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and~     neuropsychological parameters in an overweight or obese population are unknown. The aim of~     this 2-arm randomized controlled trial is to compare the effects of a 12-week~     mini-trampoline training and a 12-week nordic walking training on balance, fitness and~     strength in overweight/obese individuals.~   "
35205|NCT02596139|"~     The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to~     measure fatigue. It covers the following dimensions: general fatigue, physical fatigue,~     mental fatigue, reduced motivation and reduced activity.~      Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue~     symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and~     -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.~      A hundred adult people without diagnosed physical nor mental disabilities will be recruited.~     Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality~     Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later~     to evaluate the test-retest reliability.~      Another twenty people who are familiar with both English and Chinese will be recruited to~     evaluate the translation reliability. Subjects will fill out the English version of MFI and~     FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes~     apart. The translation reliability will be evaluated by paired t test and the intraclass~     correlation coefficient.~   "
35297|NCT02594943|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this~     study is as follows:~        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability~          to establish the correct diagnosis of diffuse gastric cancer based on collected~          biopsies from tumor tissue.~   "
35206|NCT02596126|"~     The purpose of this study is to evaluate the efficacy of a polypill strategy containing~     aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the~     standard of care (usual care according to the local clinical practices at each participating~     country) in secondary prevention of major cardiovascular events (cardiovascular death,~     nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in~     elderly patients with a recent myocardial infarction.~   "
35207|NCT02596113|"~     The investigators designed a prospective study to evaluate the predictive ability of~     detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras,~     B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the~     context of screening under international CRC prevention instructions. This investigation~     will be carried out in individuals in normal risk in order to study specific mutations (in~     blood and tissue) to draw reliable conclusions about whether we can detect (with greater~     sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood~     test thereby reducing the cost and side effects of repeated endoscopic procedures.~   "
35208|NCT02596100|"~     This is a single center open label randomized 4-period 2-sequence replicated crossover~     design study. A total of 52 healthy subjects will be randomized.~   "
35209|NCT02596087|"~     The overall goal of the IQ-MAPLE project is to improve the quality of care provided to~     patients with several heart, lung and blood conditions by facilitating more accurate and~     complete problem list documentation. In the first aim, the investigators will design and~     validate a series of problem inference algorithms, using rule-based techniques on structured~     data in the electronic health record (EHR) and natural language processing on unstructured~     data. Both of these techniques will yield candidate problems that the patient is likely to~     have, and the results will be integrated. In Aim 2, the investigators will design clinical~     decision support interventions in the EHRs of the four study sites to alert physicians when~     a candidate problem is detected that is missing from the patient's problem list - the~     clinician will then be able to accept the alert and add the problem, override the alert, or~     ignore it entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate~     the effect of the problem list alert on three endpoints: alert acceptance, problem list~     addition rate and clinical quality.~   "
35210|NCT02596074|"~     To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan~     (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).~   "
35211|NCT02596061|"~     This study aims to examine whether a combination of positive and negative commitment devices~     is effective at inducing long-term smoking cessation in smokers from a low-to-moderate~     income background. Investigators will randomly assign patients of a multi-site clinic in~     Connecticut to receive one or both of a succession of two commitment contracts. First, a~     two-month reward contract will pay participants for (a) engaging in clinic and web-based~     activities that support smoking cessation and (b) quitting smoking, as measured at period~     end. Second, a four-month deposit contract will invite participants to commit funds which~     they forfeit unless they abstain from smoking over the entire period. A random subset of~     participants will also have the option to pre-commit to the deposit contract at study~     enrollment. Reward payout and deposit recovery will be conditional on biochemical~     verification of self-reported abstinence. Investigators will conduct follow-up biochemical~     verification at 12 months to observe whether abstinence persists after removal of~     incentives. The primary outcome of interest will be continuous abstinence from smoking~     between months 2 and 12, i.e. biochemically verified abstinence at all three measurements. A~     short baseline and endline survey will also be administered to measure characteristics and~     outcomes related to smoking behavior.~   "
35212|NCT02596048|"~     This is a Phase IV multicenter, open-label study and is being implemented in order to assess~     diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography~     (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries~     with IOMERON.~   "
35213|NCT02596035|"~     This protocol will generate safety data on nivolumab monotherapy for advanced Renal Cell~     Carcinoma (RCC) patients and will have as its primary objective, the assessment of high~     grade immune-mediated adverse events (IMAE) in this patient population treated with~     nivolumab. In addition to continuing the investigation of safety for RCC patients with clear~     cell histology and prior treatment with anti- vascular endothelial growth factor (VEGF)~     therapy, this study will explore the safety and efficacy data for RCC patients with~     non-clear cell histology and RCC patients with either histology and brain metastases.~   "
35214|NCT02596022|"~     Repeated drug consumption may progress to problematic use by triggering neuroplastic~     adaptations that attenuate sensitivity to natural rewards while increasing reactivity to~     craving and drug cues. Converging evidence suggests that glutamate modulation may work to~     correct these adaptations and rapidly restore motivation for delayed non-drug rewards~     relative to immediate drug use. Using an established laboratory model aimed at evaluating~     behavioral shifts in the salience of cocaine now vs. money later, the investigators will~     test the effect of CI-581a on cocaine self-administration as compared to the active control.~   "
35215|NCT02596009|"~     The purpose of this study is to compare dynamic inspiratory flow rates achieved by a~     population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®,~     Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo will be~     administered to patients in this study.~   "
35216|NCT02595996|"~     This is a study to investigate the safety and efficacy of propranolol in the treatment of~     patients with primary lymphedema. The primary goal is to assess patient tolerability of~     increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and~     signs in response to propranolol treatment.~   "
35217|NCT02595983|"~     The purpose of this study was to evaluate the safety and effectiveness of revusiran~     (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis, whose disease has continued~     to worsen after liver transplantation. Dosing has been discontinued; patients are being~     followed-up for safety.~   "
35218|NCT02595970|"~     Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported~     Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,~     tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus~     extension) in patients with moderate to severe psoriasis.~   "
35219|NCT02595957|"~     Background:~      Genes are the instructions a person s body uses to function. Genome sequencing is a new way~     to look at genes that your main research team is using to learn the causes of the condition~     they are studying. When a new cause is found this way, it is called a primary variant. Each~     person has many variants. Most do not cause disease. Sequencing can also find secondary~     variants. These are not related to the condition your main research team is studying, but~     may show a person to be at high risk for cancer or another condition. Researchers want to~     learn more about what it means to have a secondary variant.~      Objectives:~      To find new gene changes that lead to certain medical conditions. To better understand the~     causes of certain diseases. To learn about how people understand their genetic test results.~      Eligibility:~      People with rare diseases who have already consented to and enrolled in another protocol run~     by a group other than the National Human Genome Research Institute.~      Design:~      DNA samples that were already collected will be studied.~      Participants may be asked to send in a second DNA sample (blood or saliva). These will be~     used to verify any findings.~      If a primary variant for the participant s health condition is found through genome~     sequencing, this will be shared with the participant by their primary research team.~      If the participant has a secondary finding, it will be shared by phone call or~     videoconference by this research group in the National Human Genome Research Institute. Some~     participants may get their results in person at the clinic.~      Three months after getting their secondary findings, participants will do an online survey~     and phone interview. They will be asked about how they have used the information.~      Some people who do not receive a secondary finding from genome sequencing will be asked to~     do an online survey three months after the get that result.~      Participants who have a secondary finding can get genetic counseling.~   "
35220|NCT02595944|"~     This randomized phase III trial studies how well nivolumab after surgery and chemotherapy~     work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal~     antibodies, such as nivolumab, may stimulate the immune system in different ways and kill~     tumor cells remaining after surgery and standard of care chemotherapy.~   "
35221|NCT02595931|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and~     irinotecan hydrochloride in treating patients with solid tumors that have spread to other~     places in the body and usually cannot be cured or controlled with treatment (advanced) or~     cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
35222|NCT02595918|"~     This pilot clinical trial studies the side effects of nivolumab and how well it works in~     treating patients with high-risk kidney cancer that has not spread to other places in the~     body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor~     cells to grow and spread.~   "
35223|NCT02595905|"~     This randomized phase II trial studies how well cisplatin works with or without veliparib in~     treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA)~     mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Veliparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if~     cisplatin is more effective with or without veliparib in treating patients with~     triple-negative and/or BRCA mutation-associated breast cancer.~   "
35224|NCT02595892|"~     This randomized phase II trial studies how well Ataxia-telangiectasia and Rad3-related [ATR]~     kinase inhibitor VX-970 (VX-970) and gemcitabine hydrochloride work compared to standard~     treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary~     peritoneal, or fallopian tube cancer that has come back after a period of improvement~     (recurrent). ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking an~     enzyme needed for cell growth, and may also help gemcitabine hydrochloride work better.~     Gemcitabine hydrochloride is a drug used in chemotherapy that works to stop the growth of~     tumor cells by blocking cells from growing and repairing themselves, causing them to die. It~     is not yet known whether adding ATR kinase inhibitor VX-970 to standard treatment with~     gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating~     patients with ovarian, primary peritoneal, or fallopian tube cancer.~   "
35225|NCT02595879|"~     This phase I trial studies the side effects and best dose of triapine when given with~     radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vulvar~     cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell~     growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their~     deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard~     treatment with cisplatin and radiation therapy may kill more cancer cells.~   "
35226|NCT02595866|"~     This phase I trial studies the side effects of pembrolizumab in treating patients with human~     immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not~     respond to treatment (refractory), or have distributed over a large area in the body~     (disseminated). Monoclonal antibodies, such as pembrolizumab, may block tumor or cancer~     growth in different ways by targeting certain cells. It may also help the immune system kill~     cancer cells.~   "
35227|NCT02595853|"~     Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study~     is to determine effectiveness of Hemospray™ on short and medium term in different clinical~     situations, predictive factors of rebleeding after Hemospray™ application, and feasibility~     of the application of hemostatic powder in routine clinical practice studying in a large~     sample of patients.~   "
35228|NCT02595840|"~     The aim of Trans-MARBLE is to identify and validate novel biomarkers of response and~     resistance to maintenance therapy with afatinib or pemetrexed in patients with EGFRmutated~     non-small-cell lung cancer who have progressed after first-line therapy with afatinib.~   "
35229|NCT02595827|"~     Providers in integrated Community Case Management (iCCM) programs in low resource settings~     often see children without any danger signs, presenting with fever but not having pneumonia,~     malaria, or diarrhea. These children are sent home (often with analgesic only), and~     caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if~     conditional return advice (i.e. return in 2 or 3 day only if your child is still sick)~     results in the same proportion of children remaining with fever one week after~     identification, as the current universal return advice.~   "
35230|NCT02595814|"~     The clinical characteristics, initial presentation, management, and outcomes of patients~     hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of~     chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and~     observational HF disease registry designed to characterize patient trajectories~     longitudinally during and following an index hospitalization for acute HF.~   "
35298|NCT02594930|"~     The purpose of this study is to determine whether an undirected synovial biopsy technique~     has the same accuracy in detecting periprosthetic joint infection in the knee as an~     arthroscopic assisted directed synovial biopsy technique.~   "
35231|NCT02595801|"~     The central hypothesis is that surgery and anesthesia exposure in children with immature~     structural and functional brain development has long-term adverse effects on child~     development at school-entry compared with children not exposed to anesthesia.~      The secondary hypothesis is that frequency of surgery and anesthesia exposure in children~     with immature structural and functional brain development has a dose-dependent association~     with worsened child development outcomes at school-entry.~      The overall objective is to investigate the association between surgery/anesthesia~     exposure(s) in children in Ontario and major child development outcomes (physical health and~     well being, social competence, emotional maturity, and language and cognitive development)~     at school entry as measured by the Early Development Instrument.~   "
35232|NCT02595788|"~     Transoesophageal ultrasound examination before and after prone position.~   "
35233|NCT02595775|"~     This project aims to measure the impact of a physician report card (also called an audit &~     feedback report) on colonoscopy performance. Endoscopists in Ontario will be randomly~     assigned to either receive the endoscopist report card or to no feedback. Using Ontario~     health administrative data, the quality of colonoscopy will be compared between those who~     received the report card and those who do not. The investigators will also measure the~     effect of receiving endoscopist report card on colonoscopy performance amongst endoscopists~     who perform poorly at baseline compared to those who do not. Further, the acceptability of~     two educational interventions that aim to improve the quality of colonoscopy will be~     evaluated by conducting one-on-one interviews with select participants. This study is~     critical to ensure that Canadians have access to the highest quality colonoscopy possible.~   "
35234|NCT02595762|"~     This prospective, observational study will evaluate treatment modalities and clinical~     outcomes among Greek males and females with HER2-positive unresectable locally advanced~     breast cancer (LABC) or metastatic breast cancer (MBC). No treatment regimen is mandated for~     this observational study. The treating physician will make all treatment decisions according~     to his/her regular practice independent of this study.~   "
35235|NCT02595749|"~     Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and~     neural processes that encode, interpret, and respond to socially and emotionally relevant~     stimuli) have been implicated in tobacco smoking and relapse, however this potential target~     for medication development has not been systematically examined. Evidence from animal and~     human laboratories indicate that administration of intranasal oxytocin enhances~     socioemotional processing and may be efficacious for the treatment of drug addiction,~     including nicotine dependence. In order to evaluate the potential efficacy of intranasal~     oxytocin for smoking cessation, this laboratory-based proposal will examine whether~     intranasal oxytocin attenuates smoking lapse, nicotine withdrawal, and socioemotional~     processing disruptions in regular smokers following overnight abstinence.~   "
35236|NCT02595736|"~     The purpose of this study is to look at the safety and tolerability of single doses of~     LY3200327 when given to healthy male and female participants either by injection under the~     skin or by drip into a vein. The study will help determine how the drug behaves inside the~     body and how long it takes to disappear from the body. The study will also look for~     anti-drug antibodies and how these may affect how LY3200327 acts in your body.~      The study is expected to last approximately 12 weeks (with screening evaluations up to 4~     weeks prior).~   "
35237|NCT02595723|"~     This study is designed to test if megestrol acetate induces changes in declarative memory in~     healthy controls and if pre-administration of phenytoin can ameliorate any induced cognitive~     impairments.~   "
35238|NCT02595710|"~     Approximately 20 volunteers who have received a liver transplant and have been diagnosed~     with cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples~     will be analyzed for Bartonella spp..~   "
35239|NCT02595697|"~     The goal of this study is to conduct an efficacy trial to determine whether an early~     communication intervention which blends two evidence-based interventions, Enhanced Milieu~     Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER),~     improves social communication in toddlers with Autism Spectrum Disorder (ASD).~   "
35240|NCT02595684|"~     Obesity is a chronic disease of multifactorial etiology that develops from the interaction~     of the influence of nutritive , metabolic , cellular and molecular psychological factors.~      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for~     inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile~     dysfunction, and recently approved for the treatment of pulmonary hypertension , it is~     innovative because of its longer life means, provides efficacy after 36 hours and the~     highest selectivity.~      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and~     insulin secretion in obese men.~      The investigators hypothesis is that the administration of tadalafil improve the insulin~     sensitivity and insulin secretion in obese men.~   "
35241|NCT02595671|"~     The purpose of this study is to carry out a field trial to evaluate the effectiveness and~     added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese~     adults.~   "
35251|NCT02595541|"~     Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance~     (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements.~     Pulmonary arterial hypertension is a frequent complication of congenital heart disease,~     particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the~     pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling~     and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to~     reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate~     to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial~     pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP~     ratio of < 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension,~     and a ratio of > 0.5 is indicative of severe pulmonary hypertension~   "
35252|NCT02595528|"~     This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed~     in combination once a day for the improvement of uncorrected near visual acuity in~     participants with presbyopia (inability to focus on items close-up).~   "
35309|NCT02594787|"~     The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or~     without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite~     (using visual analogue scales) in lean and obese healthy subjects~   "
35242|NCT02595658|"~     People with Type 1 diabetes (T1DM) are usually provided guidance on how best to control~     glycaemia around meal times through adjusting their rapid-acting insulin dose according to~     the carbohydrate content of the meal (e.g. 1 IU per 10/15 g of carbohydrate; Schmidt et al.,~     2014). However, a potential issue around this method is the role of dietary fat in the~     calculation of insulin requirements (Wolpert et al., 2013). The fat component of the meal~     has the potential to influence the insulin dose requirement to normalise postprandial~     glycaemia (Wolpert et al., 2013). Although normalising postprandial glycaemia is vital,~     postprandial lipaemia is also an important consideration for long-term health, and at~     present there is scant data in this area in T1DM. In addition, changing the macronutrient~     composition of foods and altering insulin doses may carry important implications for~     vascular function and prospective appetite regulation.~      This research will examine the glycaemic and lipaemic responses after consuming a mixed meal~     similar in carbohydrate content, but differing in fat content. Moreover, this research will~     assess whether acute postprandial reductions in insulin sensitivity can be offset through~     increasing the dose of rapid-acting insulin for such meals. Venous blood samples will be~     collected before and for 6 hours after meals, for the determination of glycaemic and~     lipaemic responses, as well as metabolite and hormonal parameters. In addition this study~     will assess the impact of mixed meals and adjusting insulin dose on vascular function and~     subjective ratings of appetite.~      The findings from this study will benefit patients with type 1 diabetes by the provision of~     more refined self-management strategies for insulin dosage around meal-times.~   "
35243|NCT02595645|"~     Colorectal cancer ist the 2nd most leading cancer among men and women in germany. Screening~     colonoscopy has the potential to detect premalignant lesions. By endoscopical resection of~     these lesions, colorectal cancers could be avoided. The decision for surveillance is made~     according to patients medical history, amount and histological characteristics of the~     resected polyps. Molecular guided decisions are still missing. Thus, further tools and~     mechanisms, beyond but in addition to endoscopy and histopathological, are strongly required~     to reduce such interval carcinomas and get a better and deeper inside into molecular~     alterations which occurs in premalignant lesions in the colon and describe risk populations~     which might benefit from shorter surveillance strategies by colonoscopy. Therefore GENESIS~     will enroll 100 patients, which underwent screening colonoscopy with polyp ectomy. All~     biopsies were stored and processed without formalin in special boxes (PaxGene by Qiagen®).~     After microdissection of polyp tissue and isolation of DNA targeted next generation~     sequencing of 38 cancer-related genes followed by bioinformatics and systems biology~     analyses. The sequencing results were correlated to the endoscopical and histopathological~     findings. In parallel we are collecting EDTA-blood samples for analysis of circulating~     cell-free DNA (cfDNA) to investigate the potential of liquid biopsies in premalignant~     colorectal lesions.~   "
35244|NCT02595632|"~     The purpose of this study is to detect a specific profile of breath in healthy subjects by~     an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.~   "
35245|NCT02595619|"~     This study aims to assess whether in patients with acute kidney injury (AKI) requiring~     mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and~     extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau~     pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.~   "
35246|NCT02595606|"~     A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium~     Hyaluronate in the treatment of Dry Eye of diabetic patients.~   "
35247|NCT02595593|"~     This is a multicenter randomized study investigating the differences in clinical outcomes of~     patients between two standard of care pathways for rib trauma: patients who receive rib~     fixation versus patients who receive modern critical care and pain control after sustaining~     clinically significant rib fractures from trauma.~   "
35248|NCT02595580|"~     Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin~     producing cells in the pancreas are destroyed and the subject is left totally dependent of~     external supply of insulin. There is no known cure for DM1 except for in very specific~     situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to~     normal levels.~      As an aid to subjects with DM1 for managing their blood glucose levels as close to normal as~     possible, blood glucose monitoring systems have been developed. Available blood glucose~     monitoring systems today require a capillary blood sample that is analysed by a glucose~     meter. Subjects are normally advised by health care professionals on the appropriate blood~     glucose monitoring regime for their condition. However, many subjects fail to measure blood~     glucose as often as needed to achieve good blood glucose control despite every effort from~     health care professionals.~      Research and development of non-invasive interstitial blood glucose monitoring methods is~     ongoing. All attempts to develop a non-invasive continuous glucose measuring device have so~     far failed. Prediktor Medical AS has developed a non-invasive sensor, GlucoPred, based on~     the combination of several non-invasive measurement principles and multivariate analysis and~     dynamic models of glucose/insulin interaction. The device will be body mounted in the form~     of a bracelet or a watch communicating with a mobile phone or a tablet for data presentation~     and collection. Development of GlucoPred is now at a stage where testing of the sensor in~     subjects under controlled settings is required before further development can take place.~      If successful, this will be a major step ahead for all patients with diabetes and markedly~     increase their possibility to take care of their disease on a day to day basis without the~     burden of frequent blood sampling or wearing an invasive device.~   "
35249|NCT02595567|"~     The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural~     catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to~     conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of~     fluid in the pleural space between the chest wall and the lung and occurs in 5-10% of~     patients with liver disease. Despite medical therapy with diuretics and salt restriction,~     many patients still experience intractable, debilitating shortness of breath, often~     necessitating hospital admission. Repeated thoracentesis,which is a procedure in which the~     hepatic hydrothorax is drained with a needle may be effective, but is often only temporary~     prior to the reaccumulation of fluid leading to the requirement of repeated procedures.~     Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH,~     is not always effective or able to be performed. Similarly, liver transplantation although~     potentially curative, is not available to many patients and may be significantly delayed.~     Many patients do not experience sufficient or timely relief with current conventional~     therapy.~   "
35250|NCT02595554|"~     Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome~     to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a~     hypothesis in terms of survival and treatment related morbidity.~   "
35253|NCT02595515|"~     Infantile colic is condition that affects more than 10% of babies and their families. The~     reason, and hence proper treatment, for this condition is unknown and many causes have been~     suggested. One of the treatments that parents choose is chiropractic manipulation. In~     Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion~     is due to colic. However, the effect of chiropractic treatment of infantile colic has not~     been properly scientifically evaluated.~      The effects of chiropractic treatment on infantile colic needs to be investigated, since~     this is a very common disorder with no known effective treatment, but with good empirical~     evidence of the value of chiropractic treatment. Although it is usually considered to be a~     benign and self-limiting condition, some studies suggest there might be long-term effects in~     terms of psychomotor problems. In worst case, the infants' crying may also lead to violence~     and 'shaken baby syndrome'.~      Null hypothesis: There is no effect of chiropractic treatment on the course of infantile~     colic.~      This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria~     for colic will be randomized into two groups. One group will receive treatment and the other~     won't. This will determine the overall effect and furthermore, subgroup analyses will be~     performed to identify possible subgroups of infants, who will benefit the most from the~     treatment.~   "
35254|NCT02595502|"~     The purpose of this investigation is to evaluate the short-term, clinical performance of two~     silicone hydrogel daily disposable contact lenses.~   "
35255|NCT02595489|"~     In this pilot study, the investigators will assess the safety of two high-dose regimens of~     oral vitamin D supplementation and measure the effects of vitamin D supplementation on~     markers of oxidative stress and inflammation in the blood and brain of study participants~     before, during, and after taking vitamin D supplements.~      The goal of the study is to establish research measures (i.e. biomarkers) and an optimal~     dose for vitamin D supplementation in boys with the X-linked adrenoleukodystrophy (ALD)~     genotype.~   "
35256|NCT02595476|"~     A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI,~     in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25~     and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml).~     Pupillary reflex dilation is recorded after each stimulation.~   "
35257|NCT02595463|"~     The purpose of this study is to determine whether giving lidocaine intravenously during and~     after a tonsillectomy surgery is effective in decreasing postoperative pain.~   "
35258|NCT02595450|"~     This is a non-interventional, open label, single arm, multicenter study to assess the safety~     and efficacy of erlotinib in participants with non-small cell lung cancer.~   "
35259|NCT02595437|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered~     intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis~     (CKD-5HD). It is an open-label, two-period sequential dosing study.~   "
35260|NCT02595424|"~     This randomized phase II trial studies how well temozolomide and capecitabine work compared~     to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine~     carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the~     body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as~     temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better~     to treatments other than the current standard treatment of cisplatin and etoposide. It is~     not yet known whether temozolomide and capecitabine may work better than cisplatin and~     etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small~     cell neuroendocrine carcinoma.~   "
35261|NCT02595411|"~     The aim of the study is to investigate the reliability of the Melbourne Assessment.~   "
35262|NCT02595398|"~     The study is designed to evaluate the safety and efficacy of suprachoroidally administered~     triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with~     non-infectious uveitis.~   "
35263|NCT02595385|"~     The aim of this study is to compare retrograde autologous priming (RAP) of the bypass~     circuit to cell salvage (CS) as part of blood conservation strategies in adult cardiac~     surgery. It hypothesizes that RAP is at least as effective as cell salvage in terms of blood~     conservation but at the same time more cost effective.~   "
35264|NCT02595372|"~     In preliminary laboratory science studies, the investigators show that proton pump~     inhibitors (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer~     cell survival. A preliminary retrospective study shows that PPI usage in breast cancer~     patients during chemotherapy significantly improved overall survival. The impact was most~     striking in patients with triple negative breast cancer (TNBC). Thus, PPIs may be~     repositioned as safe and effective breast cancer drugs to enhance the effect of~     chemotherapy.~      Many of the hurdles that slow progress from target, to lead compound, to investigational~     agent, to standard therapy are not barriers for the PPIs. The PPIs are FDA-approved,~     chronically used, and well tolerated so the investigators can move quickly from the~     laboratory to a proof of concept clinical trial. Incorporating the PPIs into standard care~     will require more than the investigators propose here, but the investigators have already~     plotted the additional steps needed to truly impact patient care. If successful, the data~     gathered in this proposal will lend support to and guide development of a definitive~     randomized trial.~   "
35265|NCT02595359|"~     The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of~     intracameral moxifloxacin for prevention of postcataract endophthalmitis.~   "
35266|NCT02595346|"~     This study evaluates the benefits of hydroxychloroquine on arterial function in~     antiphospholipid syndrome.~      Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine~     and standard treatment, the other will receive placebo in addition of standard treatment.~   "
35267|NCT02595333|"~     This study aims to compare the pain degree between primary cesarean section and repeated~     cesarean section, and investigate the role of flurbiprofen axetil in postoperative~     analgesia, so as to provide reference for clinical practice.~   "
35268|NCT02595320|"~     The purpose of this study is compare two different doses of capecitabine to see if one is~     better than the other in terms of efficacy and toxicity.~   "
35271|NCT02595281|"~     HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of~     serum HE4 before surgery has been demonstrated to predict overall survival and its interest~     has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk~     patients. To date, no study shows clearly the predictive potential of serum HE4 as an early~     relapse biomarker in ovarian cancers.~   "
35272|NCT02595268|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.~   "
35273|NCT02595255|"~     While most of the children spontaneously recover menstruation or experienced normal puberty~     after chemotherapy, their ovarian reserve may be impaired by treatment inducing future~     infertility. Fertility preservation is currently proposed for selected prepubertal patients~     with a high risk of premature ovarian failure after treatment (mostly conditioning regimen~     for bone marrow transplantation). For patients with low or moderate risks, counselling is~     very difficult and no fertility preservation procedure is usually proposed for these~     patients as no marker of the ovarian reserve has been validated in this young population to~     assess the individual risk.~      The primary objective of the study is to prevent long-term treatment-related infertility by~     detecting the young patients who normally progressed to menarche but have a reduced ovarian~     reserve. These patients may benefit from particular follow-up and fertility preservation~     procedure.~   "
35274|NCT02595242|"~     The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome~     Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the~     treatment of Diffuse Large B Cell Lymphoma.~   "
35275|NCT02595229|"~     Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar~     plate fixation of distal radius fractures with regard to the forearm pronation strength.~     During the early recovery period of 3 months an improvement of pronation strength and~     functional scorings was hypothesized for the PQ repair when compared to no repair.~      Randomization of the patients in two groups ( PQ repair and no repair) and follow-up~     examinations after 6 and 12 weeks included bilateral isometric pronation strength~     measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue~     scale (VAS)~   "
35276|NCT02595216|"~     Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult~     volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a~     single treatment to the submental area with the profound device; subjects will return to~     four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.~      Prior to treatment, tissue will be treated with injected tumescence or local dermal~     infiltration solution according to the protocol.~   "
35277|NCT02595203|"~     The primary objectives of this study are:~        -  To determine the mass balance recovery (expired air, urine and faeces) and route and~          rate of elimination of 14C-Debio 1450.~        -  To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and~          faeces.~        -  To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug)~          and Debio 1452 (active moiety) in plasma and urine.~   "
35278|NCT02595190|"~     There are very few data and analysis in the literature regarding the symptomatic sacral~     perineurial cysts. Most studies are case reports or small retrospective sample, which rarely~     more than 20 cases. There is no an consensus on the choice of treatment (medicine~     conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our~     aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical~     treatment for symptomatic sacral perineurial cysts by a randomized controlled trial.~     Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes~     at pain related brain areas, which will be develop an objective method to evaluate the~     clinical curative effect of the two treatment options.~   "
35279|NCT02595177|"~     To compare refractive outcomes and patient's visual quality after bilateral cataract surgery~     when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.~   "
35280|NCT02595164|"~     The role of impulsivity and its contribution to suicidal behavior seems intuitively clear.~     Empirical results have proved the existence of a relationship between the two yet many~     questions are left unanswered, especially what differentiates suicide ideators from~     attempters.. Obsessive thinking patterns are thought processes which share a repetitive~     behavior domain and are exerted by an inner voice. 3 types of obsessive thinking patterns~     are self destructive thoughts, ruminations and overvalued ideas. Impulsivity and obsessive~     thinking patterns are presumed to have a common mechanism of behaviors which are resulted~     from basal ganglia dysregulation and thus effect inhibition. Novel research in the field of~     decision making could help to learn more about behavioral patterns associated with self harm~     behavior and suicide. Eating Disorders involve suicidal and self harm behavior, which both~     feature impulsivity and obsessive thinking patterns. The investigators study proposes a~     3-step theoretical model which asserts there is a connection between impulsivity, obsessive~     thinking and poor decision making, all effecting self harm behavior. Contemporary research~     has not been able to fully understand the nature of impulsivity and its effect on self harm~     behavior, including eating disorders symptoms, nor addressed the impact of obsessive~     thinking patterns on the latter. 100 female participants with Eating Disorders and suicidal~     behavior will be recruited for the proposed research. Subjects will be given self-report~     questionnaires and computerized behavioral tasks. A one way ANOVA of two eating disorder~     subgroups, impulsive and non impulsive, will be conducted, following a hierarchical multiple~     regression with self harm behavior being the dependent variable.~   "
35281|NCT02595151|"~     The morphologic change of microvessels has the clinical value to distinguish cancerous from~     non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory~     hemodynamic changes real-time using pCLE, compare the differences between chronic~     nonatrophic gastritis and GIM; then evaluate the possible mechanisms associated with gastric~     mucosal blood flow in GIM.~   "
35282|NCT02595138|"~     Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and~     limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options.~     Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating~     the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant~     therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who~     were receiving aromatase inhibitors. So it might be able to improve the survival of triple~     negative breast cancer patients.~   "
35283|NCT02595125|"~     Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years~     depending on the model) and among the most effective. However, there are many obstacles to~     the use of IUDs including pain felt by patients during installation. Several medical means~     were studied without evidence of their efficacy in pain related to IUD insertion. In order~     to remove this brake, it's important to find another way to act against this pain. The~     direct technique is one of the techniques described by health professionals. It seems~     trusted by its users as a more reliable technique but also less painful for patients.~     However, there is no study available on its evaluation. The aim of this study is to~     investigate the interest of the direct technique in reducing the pain experienced by~     patients during installation.~   "
35284|NCT02595112|"~     Staphylococcus aureus nasal carriage is a major risk factor of infection with this~     bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still~     misunderstood. This study is aimed at evaluating the relationship between Staphylococcus~     aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the~     nasopharynx.~   "
35285|NCT02595099|"~     The purpose of this project is to investigate the feasibility and acceptability of a~     Mindfulness based intervention for people who are attending secondary care with~     Osteoarthritis (OA)-related knee pain.~   "
35286|NCT02595086|"~     The aim of this study is to show better postoperative quality of life including lower~     incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving~     gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with~     middle-third early gastric cancer~   "
35287|NCT02595073|"~     Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate~     to Severe Atopic Dermatitis~   "
35288|NCT02595060|"~     This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients~     with community-associated pneumonia (CAP)-related acute respiratory distress syndrome~     (ARDS). A third of the patients will receive 150 mcg inhaled molgramostim, another third 450~     mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be~     followed for 28 days.~   "
35289|NCT02595047|"~     The purpose of this study is to observe the feasibility and its application of autologous~     prefabrication for body surface tissues/oranges~   "
35290|NCT02595034|"~     This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl~     Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel~   "
35291|NCT02595021|"~     The purpose of this study is to evaluate the safety and one year disease-free survival of~     total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial~     ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).~   "
35292|NCT02595008|"~     this study is to evaluate the potential of DSXS to suppress HPA axis function in patients~     with moderate to severe atopic dermatitis.~   "
35293|NCT02594995|"~     Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of~     deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of~     blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral~     tissue distal to an arterial occlusion depends on collateral circulation via the Circle of~     Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated~     with infarct growth. The presence of adequate collaterals has been shown to be associated~     with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated~     from the seeds of celery, and found to exert protective effects against ischemic brain and~     increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed~     during acute stroke will have a significant effect to improve collateral circulation in~     patients of anterior circulation occlusion.~   "
35294|NCT02594982|"~     Abstract Background Studies have shown that delirium in medical and surgical intensive care~     units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia~     symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium~     in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two~     instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment~     Method for the ICU (CAM-ICU).~      Aims~        1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and~          pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.~        2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method~          The design of the study is a two-phase interventional trial. Based on a power~          calculation, 56 patients will be enrolled both in the baseline and the intervention~          group (n=112).~      Part 1: A baseline investigation will be conducted to establish prevalence, duration and~     type of delirium symptoms in patients with acute acquired brain injury before implementing~     the intervention bundle.~      Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The~     Intervention elements consist of a sedation, sleep, mobilization and pain treatment regimen~     based on the newest available evidence.~      Enrolled patients will be contacted 12 months after discharge for a follow-up including a~     quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive~     end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short~     test for dementia symptoms (MMSE, Mini Mental State Examination).~   "
35295|NCT02594969|"~     The goal is this study is to investigate the effects of dilute bleach on the skin of~     subjects with atopic dermatitis and those with healthy skin. The second goal is to evaluate~     the effects of different moisturizers on the skin barrier of subjects with and without~     atopic dermatitis. The investigators hypothesize that the bleach bath will increase the skin~     pH, decrease the skin hydration, and increase skin water loss in all study subjects.~     Secondly, the investigators hypothesize that moisturizers with the lowest pH and the highest~     water to oil ratio will result in improved skin barrier function. Furthermore, the~     investigators believe there will be a greater improvement in patients with atopic~     dermatitis.~   "
35296|NCT02594956|"~     The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current~     practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity,~     delayed gastric emptying and finally an increased length of hospital stay.~      The absence of NG decompression could be the corner stone of the concept of the enhanced~     recovery program after PD.~   "
35299|NCT02594917|"~     The investigators are performing this research study to determine whether having low~     iron-sulfur cluster levels can cause a disease known as pulmonary hypertension (PH). PH is~     defined as abnormally high blood pressure in the arteries of the lungs.~      Usually, small specialized structures inside each human cell called mitochondria are in~     charge of generating energy within lung arteries for normal function. During situations of~     disease or stress, lung arteries undergo a change in teh function of mitochondria, resulting~     in the development of PH. In studies on mice, investigators have learned that alterations in~     the production of specific metal complexes called iron-sulfur clusters are responsible for~     these changes. This makes it more likely that mice will develop PH.~      In this study, the investigators want to find out if alteration of iron-sulfur cluster~     formation leads to increased likelihood of developing PH in humans.~   "
35300|NCT02594904|"~     Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason~     for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates~     may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc.~      The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia.~     When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause~     nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring~     and early intervention of jaundice has important significance to prevent further aggravation~     of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable~     methods for severe hyperbilirubinemia, however, patients need to be hospitalized.~     Yinzhihuang Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large~     sample and multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral~     Liquid in the treatment of neonatal hyperbilirubinemia is exactly confirmed.~      The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid~     on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal~     hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat~     neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.~   "
35301|NCT02594891|"~     Cholangitis is one of the main complications of endoscopic retrograde~     cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of~     post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope~     again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the~     gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of~     this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP~     cholangitis of ERCP in patients with choledocholithiasis.~   "
35302|NCT02594878|"~     In a randomized double blind placebo controlled trial to investigate the effect of~     pamidronate in treatment of chronic non bacterial osteomyelitis.~      Main objective:~        1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI~          after 36 weeks.~        2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI~          after 36 weeks.~      Secondary objectives:~        1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week~          12 and week 36~        2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between~          baseline and week 36.~        3. Changes in patient self reported outcome measures~        4. Changes in inflammatory markers and bone markers.~   "
35303|NCT02594865|"~     To investigate whether the administration of Glucerna achieves less glycaemic variability,~     defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to~     a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will~     be used to evaluate glycaemic variability and glycaemic control.~   "
35304|NCT02594852|"~     In this study the investigators want to investigate if the pregnancy rate in conjunction~     with fertility treatment increases with concomitant use of laser therapy.~   "
35305|NCT02594839|"~     The study evaluates the safety and the efficacy of the addition of intravenous~     transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic~     interstitial pneumonia or connective tissue disease associated with interstitial lung~     disease, which have actively progressing disease with rapid loss of pulmonary function on~     the background of routine treatment.~   "
35306|NCT02594826|"~     This is a randomized trial to evaluate the effects of a community-based intervention on~     increasing cervical cancer screening rates in underserved Korean American women. Due to the~     multiple factors that contribute to screening uptake, an educational program customized to~     Korean culture combined with navigation assistance may be effective in increasing the number~     of Korean American women who can access cervical cancer screening.~   "
35307|NCT02594813|"~     The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy or cold~     snare polypectomy) in patients who continue to take various antithrombotic drugs is studied~     prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other~     endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic~     clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed~     bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after~     endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy.~     Additionally, investigators evaluate the rate of injured submucosal arteries of the excised~     specimen when the bleeding occurs.~   "
35308|NCT02594800|"~     Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of~     the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis~     accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and~     other countries in Asia. AICAS is also highly associated with the risk of stroke recurrence.~     Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with~     hemodynamic compromise distal to site of stenosis.~      Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and~     cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of~     CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit~     time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage~     radioisotope counts in the region of interest (ROI) of the affected side against the~     corresponding ROI in the unaffected contralateral side.~      Statins can decrease the incidence of transient ischemic attack or ischemic stroke and~     improve stroke outcome. Few studies focus on the relationship between statins therapy and~     cerebral perfusion.~      Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can~     improve hemodynamic situation and cerebral perfusion status in AICAS has not been~     illustrated.~      Based on those studies, the investigators hypothesized that intensive rosuvastatin may also~     improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic~     plaques, but also its pleiotropic effects. So it can change the hemodynamic status around~     the plaque and increase cerebral flow in the downstream territory. So in this study the~     investigators try to analysis statin's impact on the hemodynamic changes as well as the~     downstream perfusion which is determined by CTP.~   "
35310|NCT02594774|"~     The objective is to evaluate the efficacy of osteopathic treatment as an adjunct to standard~     medical treatment in reducing child functional abdominal pain.~      A convenience sample that includes no more than 30 patients per study group (n = 60) are~     being recruited. As an exploratory study the investigators did not proceed to make any~     sample size calculation.~      This is a comparative study of two quasi-experimental interventions (standard treatment vs.~     standard treatment + Osteopathy).~      This will be a single-blind trial where only the evaluator will be blinded. The principal~     outcome will be pain measured by a visual analog scale. A version with more appropriate~     pictograms for pediatric patients is used. Measurements will be taken at baseline (baseline~     measurements) at 4, 8 weeks (the duration of interventions) and 6 months post-study.~   "
35311|NCT02594761|"~     The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan~     trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and~     pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8~     mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male~     subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square~     mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three~     similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules~     vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®.~     Secondary objectives included further pharmacokinetic assessment of similarity of Hercules,~     EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of~     safety (including immunogenicity) and local tolerance.~   "
35312|NCT02594748|"~     The aims of the study are as follows:~        -  To improve self-management intention and behavior of patients with type 2 diabetes (T2~          DM).~        -  To promote patients to make plans for their self-management and gradually integrate the~          self-management plan into their daily life.~        -  To improve resilience, well-being, fatigue and quality of life of patients with T2 DM~      In order to achieve the aims, we have set the following objectives:~        -  To develop and apply self-management education program based on the extended theory of~          planned behavior.~        -  To evaluate the efficacy of the educational program:~             1. Self-management education program delivered face to face (intervention group); (b)~               standard usual care (comparison group).~   "
35313|NCT02594735|"~     The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in~     10 patients eight years of age and older with refractory JDM.~   "
35314|NCT02594722|"~     Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to~     peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major~     limitation of daily activity and quality of life. Technologies likes' neuromuscular~     electrical stimulation (NMES) are currently being adapted and tested to support exercise~     training.~      The investigators hypothesized that functional electrical stimulation cycling improves VO2~     and aerobic capacities during exercise compared to endurance training.~   "
35315|NCT02594709|"~     Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation,~     surgery and radiotherapy, but to date none of these has become the clear treatment of~     choice.~      The role of the radiotherapy remained uncertain because of the concern about radiation~     related optic neuropathy In the recent past two large series of patients treated with a~     fractionated stereotactic radiotherapy confirmed these positive experiences in tumour~     control and greatly reduced the concern about the treatment related toxicity.~      Under the light of successful meningiomas treatment, radiosurgery, had proposed as a~     treatment option. Single session, high conformality, frame based radiosurgery systems are~     seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic~     nerve.~      The first experience in ONSMs treatment with multisession radiosurgery treatment was quite~     promising.~      The aim of the present study is to prospectively evaluate the efficacy and safety of~     multisession radiosurgery in ONSMs treatment.~      In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present~     study.~      All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy~     each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated~     both for tumor growth control and visual function.~   "
35316|NCT02594696|"~     Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder~     are dying younger than the general population; cancer is a leading cause of death in this~     population. People with SMI have higher rates of dying from breast, lung, and colon cancer,~     and disparities in treatment appear to be one contributing factor. Individuals with SMI may~     be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate~     cancer treatment. Although collaborative care models integrating medical and psychiatric~     care have shown promise in other populations, the challenge of treating SMI and cancer is~     distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms~     that can impact their understanding of their diagnosis and treatment decisions. Oncologists~     have less training and inadequate time to address multiple unmet needs. Mental health care~     is frequently fragmented from cancer care.~      The investigators want to understand if it is helpful for patients with SMI to be connected~     to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms~     and facilitating communication between the patient, the oncology team, and mental health~     providers may improve care. The goal is to pilot a pragmatic intervention for patients with~     cancer and SMI that can be integrated into cancer care, is acceptable to patients and~     oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to~     an underserved population.~      Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will~     follow the patient and communicate with the oncology team during the 12 week intervention.~     All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology~     clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment~     received and healthcare utilization will be assessed at 6 months post-intervention.~   "
35317|NCT02594683|"~     A follow-up study of a randomised, controlled, study to investigate the effects of a new~     infant formula given in the first 12 months of life on growth and body composition up to 5~     years of age~   "
35318|NCT02594670|"~     Selecting different acupoints as an combination of acupoints is a key factor to clinical~     efficacy of acupuncture. Different combinations of acupoints will generate different~     clinical efficacy. So,the purpose of this study is to determine the different clinical~     efficacy among three types of combinations of acupoints in the treatment of primary~     insomnia.~   "
35368|NCT02594020|"~     This study concerns the prevention of dental caries by sealing pits and fissures of~     permanent molars with a photopolymerizable resin. It must compare these three techniques~     Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare~     micro cavities in the enamel and / or the outer third of the dentin. These three commonly~     used techniques have never been compared by retaining as endpoint retention of sealant.~     These techniques are painless and do not require local anesthesia.~   "
35319|NCT02594657|"~     Nowadays, ECC exercise can be realized using various modalities that target small or large~     muscle masses in a segmentary or dynamic way. The training program proposed in this study is~     realised on an handmade ergocycle which allows eccentric contractions.~      With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an~     exercise realised at the same power output with a concentric ergocycle. Due to this later~     propertie, which origins are not yet fully identified, there is an increasing interest to~     embed ECC in rehabilitation programs.~      The investigators hypothesis that a higher pedal rate will induce a lower oxygen~     consumption, with the same benefits.~      This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per~     minute (rpm).~      The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and~     to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption~     observed.~   "
35320|NCT02594644|"~     The aim of this study is to investigate how varying incubation periods of topical~     aminolevulinic acid after pretreatment with microneedle application can facilitate the~     penetration and efficacy of photodynamic therapy.~   "
35321|NCT02594631|"~     The aim of the study is to compare the safety and efficacy of ESWL and visual~     cystolitholapaxy in management of calcular acute urine retention.~   "
35322|NCT02594618|"~     The aim of this study is to assess energy regulation of overfeeding and performing common~     household activities in young Chinese males using whole-body room calorimetry up to 10~     hours.~   "
35323|NCT02594605|"~     Platelet rich fibrin is a second generation platelet concentration which contains various~     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy~     of PRF in subjects of chronic periodontitis in the operation of conventional periodontal~     flap.~   "
35324|NCT02594592|"~     This cross-sectional study aimed to validate the effectiveness of the combined use of the~     Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk~     Test (IOF test) in a population from Wuhan, China.~   "
35325|NCT02594579|"~     A randomized double blind placebo control trial study will be conducted in critically ill~     patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin~     D3 supplementation, compare to placebo, on skeletal muscle mass and body composition.~   "
35326|NCT02594566|"~     If the participant decides to take part in the study, the participant will need to do the~     following:~      Visit the study clinic up to 10 times and be available for a reasonable amount of follow up~     phone calls to see how the participant is doing.~      The participant will receive three doses of vaccine injected into the muscle of the upper~     arm. After each injection the participant will be asked to remain at the study site for at~     least 30 minutes after the participant receives the study vaccine.~      The results of all of the participants blood tests, just like all other laboratory test~     results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV~     and viral hepatitis test results will be reportable to local health authorities according to~     local laws.~      The participant will be asked to refrain from excessive physical activities and alcohol~     consumption within 2 days before each clinic visit to avoid possible confusing effects on~     laboratory tests.~   "
35327|NCT02594553|"~     The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an~     interactive information booklet during consultations for febrile children at General~     Practice (GP) out-of-hours centres can reduce the number of antibiotic prescriptions,~     improve parental satisfaction and reduce intention to reconsult for childhood fever~     episodes.~   "
35328|NCT02594540|"~     The purpose of this study is to evaluate safety and effectiveness of the peripheral~     mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF~     levels, immunological profile and brain functional connectivity changes in patients with~     Parkinson's disease.~   "
35329|NCT02594527|"~     Physical activity levels of hospitalised older inpatients is low and this results in many~     adverse health outcomes. Studies have shown that interventions designed to promote increased~     physical activity of older inpatients using paid staff have shown improvement in physical~     function of older inpatients, resulting in shorter hospital stay and reduced admissions to~     nursing home. This study aims to assess the feasibility and acceptability of using trained~     volunteers to increase physical activity of older people in hospital. Volunteers will be~     recruited and trained to encourage older inpatients to mobilise or perform chair-based~     exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day~     during their hospital stay. Quantitative analysis will be conducted on the outcome measures.~     Patients, volunteers and staff members will also be interviewed to assess the acceptability~     of the intervention. This feasibility study will help inform a future controlled trial.~   "
35330|NCT02594514|"~     Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among~     adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a~     BMI >40 kg/m2 or a BMI >35 kg/m2 with at least one serious co-morbidity. The immediate and~     long-term risks associated with SO in adolescents include cardiovascular and metabolic~     diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the~     results of sleeve gastrectomy in adolescents are still uncertain.~      Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and~     cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.~      Method: Longitudinal retrospective study of 22 adolescents with SO who underwent~     laparoscopic sleeve gastrectomy. Clinical and metabolic variables immediately before surgery~     and after 6, 12, 18 and 24 months were assessed.~   "
35331|NCT02594501|"~     The purpose of this study is to determine whether patients undergoing coronary intervention~     that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual~     anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic~     events than compared with standard FDA-approved drug eluting stent (DES) plus 6-month DAPT.~   "
35332|NCT02594488|"~     The majority of deaths after myocardial infarction occurs in patients with preserved left~     ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic~     Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic~     risk markers that identify a new high risk group of patients with LVEF 35-50% who have the~     same poor prognosis as patients with LVEF ≤35%.~      In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be~     randomly assigned to biomonitoring-guided therapy or conventional follow-up.~   "
35333|NCT02594475|"~     Endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in diagnosis and~     treatment of pancreaticobiliary diseases. Traditionally, ERCP has been performed in the~     prone position. The prone position for ERCP can facilitate selective bile duct cannulation,~     offer a better fluoroscopic image of pancreaticobiliary anatomy, and prevent aspiration of~     gastric contents. However, in cases of difficult in the prone position, ERCP has been~     performed in the left lateral or supine position. Compared with the prone position, left~     lateral position is more comfortable for patients, especially with limitation for cervical~     movement including cervical cord injury, cervical spine operation, parkinson's disease,~     contracture due to cerebral infarction, and allow more easy passage of the scope through the~     pharynx, and useful to secure airway. However, in the left lateral position, it is difficult~     to obtain fluoroscopic image of right hepatic duct and intrahepatic bile duct.~      In cases of severe abdominal pain, severe abdominal distension, large amount of ascites,~     recent abdominal surgery or cervical spine surgery, intra-abdominal catheter insertion,~     severe obesity, it is difficult to position in prone or left lateral, therefore, ERCP may be~     performed in the supine position. In supine position for ERCP, there has been documented~     increased risk of cardiopulmonary adverse event and decreased success rate of selective bile~     duct cannulation.~      There have been reported the efficacy and safety between the prone position and supine~     position for ERCP in several studies. We aimed to evaluate the efficacy and safety between~     the prone position and left lateral position for ERCP in this prospective, randomized study.~   "
35334|NCT02594462|"~     Sickle cell anemia is a homozygous genetic disease with high prevalence in Brazil. There are~     changes in conformation and physicochemical properties of red cells that generate varied~     clinical manifestations among which is chronic hemolytic anemia, cardiovascular diseases,~     fever, splenic sequestration and usually painful crises. Women with sickle cell anemia have~     high maternal-fetal and neonatal morbidity and mortality. During pregnancy, there is~     intensification of maternal anemia, episodes of painful crises; and also, more obstetric~     risks, such as pre-eclampsia, thromboembolism and hemorrhage. Thus, there is the need for~     adequate reproductive family planning for this population conducted mainly through hormonal~     contraception. The World Health Organization recommends that all contraceptive methods may~     be prescribed for people with sickle cell anemia women, being the progestogen-only~     contraceptive methods the most indicated due to no changes in venous or arterial thrombosis.~     Nevertheless, there is need for further scientific evidence as the best contraceptive choice~     among women with sickle cell anemia in relation to safety, adhesion and reduction of pain~     crises. The objective of this study is to evaluate the clinical effect through safety of~     etonogestrel-releasing contraceptive implant in women with sickle cell anemia during twelve~     months.~   "
35335|NCT02594449|"~     To compare pharmacodynamics among the different concentrations of BCS and NS.~   "
35336|NCT02594436|"~     This is a prospective, non-interventional study of adult patients prescribed topical~     treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment~     of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete~     clearance at 8 weeks will be followed for one year or until retreatment of AK in the area~     initially treated, whatever comes first. For patients with incomplete clearance in the~     treated area at 8 weeks the treatment strategy for this area will be recorded but no further~     follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction~     and health-related quality of life (HRQoL) associated with Picato® treatment will be~     evaluated.~   "
35337|NCT02594423|"~     The cornea is the transparent window of the eye, which allows light to enter into the eye~     and also contributes to the focusing of the light rays. One of the major factors responsible~     for its transparency is the lack of blood vessels. However, following inflammation new blood~     vessels (corneal vascularisation [CVas]) grow into the cornea affecting its transparency and~     impairing vision. CVas leads to further damage in the form of scarring,oedema,fat deposition~     and is a major cause of corneal graft rejection.~      In 2000 with ethical approval (OY129801) the investigators developed and published a~     clinical technique called Fine Needle Diathermy occlusion of corneal vessels (FND). This has~     proven very successful for occluding established vessels and is practiced in many centers~     across the world. Recently it has been demonstrated that by inhibiting a chemical stimulant~     of vessel formation called vascular endothelial growth factor(VEGF) active new vessel growth~     in the retina can be suppressed. The approach is also being used for corneal new vessels.~     Bevacizumab (Avastin) is a chemical inhibitor of VEGF and is used extensively to treat~     retinal new vessels in macular degeneration. Avastin has been shown to be effective and safe~     in treating corneal new vessels. The investigators propose to evaluate the efficacy and~     safety of FND alone and FND combined with Avastin in treatment of CVas.~   "
35338|NCT02594410|"~     To evaluate the efficacy of renal artery stent combined with standardized medical therapy as~     treatment for renal artery stenosis.~   "
35339|NCT02594397|"~     The purpose of this study is to determine whether the different combination of acupoints~     have different effect on diabetic gastroparalysis.~   "
35340|NCT02594384|"~     This is a Phase 1 dose exploration study of LAM-002A administered by mouth in patients with~     relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK) and~     preliminary activity will be evaluated.~   "
35341|NCT02594371|"~     To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in~     metastatic breast cancer~   "
35342|NCT02594358|"~     Prospective data on the visual acuity response in children treated by patching concurrently~     treated with caffeine and estimate the magnitude of effect that might be seen in a~     randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to~     decide not to conduct a randomized, double blind trial).~      Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant~     treatment for amblyopia and provide limited data on its safety.~      Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability~     of patching on the child and family.~      Demonstrate recruitment potential of subjects to participate in a dietary intervention~     study.~   "
35343|NCT02594345|"~     This study is designed to analyze the effect exosomes derived from red blood cell units have~     on blood coagulation and platelet function. It is an in vitro study using healthy~     volunteers' blood.~   "
35344|NCT02594332|"~     The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on~     airway physiology in patients with eosinophilic asthma~   "
35345|NCT02594319|"~     This research seeks to examine psychological factors that may impact relationship between~     incentives and health behavior engagement, specifically fruit and vegetable consumption.~     Additionally, it will compare the impact of two different incentive schedules on behavior~     engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and~     another providing delayed rewards (i.e. rewards received at the end of the study period),~     with a control condition in which no rewards are offered. Study participants will provide~     reports of their fruit and vegetable consumption each day for three weeks, and in the two~     incentive conditions, they will receive small monetary rewards for their fruit and vegetable~     consumption. Following the three week reporting and reward period, participants will~     complete two additional assessments, measuring psychological constructs and behavior~     engagement following the cessation of rewards.~   "
35346|NCT02594306|"~     Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by~     non-medical usage, long and repeated exposure to addictive drugs and gradually increasing~     drug-taking dosage and frequency,and become a main threat against human being's public~     health, economic development and social safety.~   "
35347|NCT02594293|"~     This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B~     in 96 weeks after nucleoside analogue (NUC) withdrawal.~      The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and~     reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment~     guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC~     treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN~     alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC~     treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.~   "
35348|NCT02594280|"~     Establish electrophysiological benchmarks, using the Diopsys Visual Evoked Potential/~     Pattern ERG (VEP/PERG) protocols of populations with Glaucoma following: 1) Baseline VEP/ERG~     prior to treatment; and 2) VEP/PERG after treatment.~   "
35349|NCT02594267|"~     The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in~     combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen~     in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).~   "
35350|NCT02594254|"~     The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of~     time either with a toothbrush or a custom dental tray can effectively kill bacteria in the~     mouth that cause dental cavities.~   "
35351|NCT02594241|"~     Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be~     randomized to either methylprednisolone or saline preoperatively, to examine the effects of~     methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia~     repair.~   "
35352|NCT02594228|"~     A primary aim of the current proposal is to compare the effect of daily consumption of~     healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total~     daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed~     immediately following exercise training (within 30 min) and another 2 hours prior to going~     to bed at night, over a 16 week period on muscle and fat mass, cardiovascular health,~     aerobic fitness, glucose, insulin, blood lipids, heart rate and muscle strength in~     overweight men and women.~   "
35353|NCT02594215|"~     Background:~      Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein~     that communicates with other proteins in the body to make cells grow. The AKT1 mutation~     changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug ARQ~     092 reduces signals from the AKT1 protein. This may reduce or stabilize some of the~     overgrowth in people with PS. Researchers want to find the best dose of ARQ 092 based on its~     effect on tissues in people with PS.~      Objective:~      To determine the safety, tolerability, and recommended dose of ARQ 092 in people with PS.~      Eligibility:~      People ages 12 and older with PS~      Design:~      Participants will be screened with medical history, physical exam, and blood and urine~     tests.~      Participants will take ARQ 092 by mouth once daily for up to 12 28-day cycles.~      Participants must stay near the NIH Clinical Center (CC) during the whole first cycle, for~     weekly visits to the CC. For cycle 2, they will have visits every 2 weeks. They will have 1~     visit before cycles 3 and 4, and once before every other cycle for cycles 5 11. The final~     visit will be at the end of cycle 12. Visits may include:~      Small skin samples taken.~      ECG: Soft electrodes on the skin record heart signals.~      Echocardiogram: A small probe held to the chest takes pictures of the heart.~      MRI: Participants will lie in a machine that takes pictures of the body.~      Joint and mobility function tests.~      Participants will complete surveys by phone and in person.~      Participants will keep a daily medication and symptom diary.~   "
35354|NCT02594202|"~     Background:~      Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers~     want to study blood, tissue, and fluid samples of people with prostate cancer. This will~     help them understand any changes in cells and genes. These changes might lead to the~     development and progression of prostate cancer. Researchers think the study could lead to~     new treatments.~      Objective:~      To understand the changes in cells and genes that lead to the development and progression of~     prostate cancer. This could lead to new treatments.~      Eligibility:~      Men ages 18 and older who have or are suspected to have prostate cancer~      Design:~      Participants will be screened with physical exam and medical history.~      Participants will send tissue blocks of their tumor, if possible. If not, they will provide~     unstained slides of tumor tissue.~      Participants may provide samples of blood, urine, saliva, and prostate secretions.~      Participants may have imaging tests. They will lie in a machine that takes pictures of their~     body. These tests include:~      MRI of the prostate~      CT of the abdomen and pelvis~      Chest x-ray~      Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers~     will collect tissue.~      Participants may answer questions about their prostate cancer and quality of life.~      Participants may have follow-up visits or other treatments. They may have follow-up phone~     calls every few months.~   "
35424|NCT02593292|"~     This French multicentre open-label randomized trial will test the hypothesis that a~     coordinated health circuit based on obstetric risks, backed up by an electronic patient care~     reporting information system will optimize the continuum of pregnancy care monitoring. The~     electronic patient care reporting information system will be shared between patients,~     private practice physicians/midwifes, hospital physicians/midwifes and supervised by a~     coordinating midwife.~   "
35355|NCT02594189|"~     Background:~      Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also~     be more serious. Researchers want to know more about how influenza causes disease in people.~     They hope to develop new vaccines and treatments for flu infection.~      Objective:~      To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu~     infection in healthy people. Also, to study the body s immune response to this virus and how~     the infection develops.~      Eligibility:~      Healthy people ages 18 50 who are:~      Non-smokers or non-habitual smokers~      Willing to not smoke for at least 9 days~      Design:~      Participants will be screened under NIAID protocol #11-I-0183~      Participants will stay at an isolation unit at the clinic for at least 9 days. They will~     remain in the isolation unit except for study-specific activities.~      The influenza virus will be sprayed into the nose.~      Participants will be monitored 24 hours a day. They will have tests, including:~      Medical history~      Physical exam~      Daily questionnaires about symptoms~      Blood and urine tests~      Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then~     collects the~      fluid. Or the inside of the nose is rubbed with a swab.~      ECG: Measures the heart s electrical signals~      ECHO: Sound waves take pictures of the heart~      PFTs/Spirometry: They will blow into a machine that measures the air they blow.~      Participants will be discharged after they test negative for influenza A.~      Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may~     complete questionnaires at home.~   "
35356|NCT02594176|"~     Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain~     related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical~     intolerance to NSAIDs.~      Secondary Objectives~        -  To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and~          improvement of joint function in patients contraindicated for or with clinical~          intolerance to NSAIDs and with OA of the knee.~        -  To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated~          for or with clinical intolerance to NSAIDs and with OA of the knee.~   "
35357|NCT02594163|"~     This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate~     the efficacy and safety of brentuximab vedotin in combination with rituximab and~     bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse~     large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line~     treatment in patients ineligible for autologous stem cell transplant (ASCT).~   "
35358|NCT02594150|"~     A four arm randomized pilot study to assess if the rate of completion of Fecal~     Immunochemical Test is increased by the addition of financial incentives.~   "
35359|NCT02594137|"~     The purpose of this study is to compare two surgical techniques for a neurosurgical~     procedure used to treat cerebral edema (decompressive craniectomy): with watertight~     duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).~   "
35360|NCT02594124|"~     This study will test the clinical safety, tolerability, and efficacy of IONIS-SMN Rx in~     patients with SMA.~   "
35361|NCT02594111|"~     Inflammation in the arteries of the heart may increase the risk of cardiac death. The~     proposed research seeks to identify the potential beneficial role of a safe~     anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage~     in the arteries of the heart. With its quick onset of action and excellent safety profile,~     colchicine may have the potential to reduce risk of major adverse events related to the~     heart. This research also seeks to better understand the role of neutrophils, the most~     common type of inflammatory white blood cell in the body, when there is damage to the heart.~   "
35362|NCT02594098|"~     Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can~     affect males and females of all ages, but often starts in childhood. Recent studies show at~     least 4-7% of adults and 15-25% of children to be affected, with one third of patients~     having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching~     worsens the symptoms and causes the skin to become thickened over time. Patients with atopic~     dermatitis have an increased risk of skin infections, and many also develop hay fever or~     asthma. Atopic dermatitis can cause significant distress to both patients and their~     families.~      In this study, the aim is to assess the effects of a new treatment called secukinumab in~     patients with atopic dermatitis. A total of 30 patients will be included in the study, which~     will run for a total of 52 weeks.~   "
35363|NCT02594085|"~     The objective is to investigate the impact that faecal output has on adhesives.~   "
35364|NCT02594072|"~     Two radiation therapy techniques are commonly used for the treatment of intermediate and~     high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT).~     However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into~     the prostate, produces excellent outcomes but is invasive and not all patients are eligible~     or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to~     be very prolonged and may have poorer outcomes than brachytherapy. This study will examine~     the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a~     few, high dose radiation treatments. Treatments are short, non-invasive, applicable to~     patients not able to do brachytherapy, and may be more effective than conventional EBRT.~     This study will compare SABR with EBRT in terms of the rates of acute and late toxicities~     for each treatment, disease-free survival, and health-related quality of life measures.~   "
35365|NCT02594059|"~     The aim of the study is to assess the peripheral endothelial function in adult patients with~     idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial~     function and the severity of the IPF.~   "
35366|NCT02594046|"~     This randomized, placebo-controlled, double-blind study evaluates the efficacy and~     tolerability of the allogeneic human adipose derived stem cell component extract on~     androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of~     allogeneic human adipose derived stem cell component extract per month or a placebo for 16~     weeks.~   "
35367|NCT02594033|"~     This trial is conducted in Europe. The aim of the trial is to investigate different needle~     features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the~     trial drug in the body).~   "
36316|NCT02581657|"~     This study is a randomized, double-blind (Investigator and study subject), placebo~     controlled multiple dose sequential ascending dose study that will enroll up to 47 male and~     female subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.~   "
35369|NCT02594007|"~     Heart Failure (HF) affects 5.7 million Americans and is the only major cardiovascular~     disorder on the rise. The primary aim of this study is to formally study the combined~     effects of several different tele-health modalities, all currently approved and available~     for general use, to determine if such combinations will result in an increase in early~     intervention and a resultant decrease in acute cardiac decompensation requiring a~     hospitalization or Emergency Room (ER) visit. This study will attempt to characterize the~     frequency of health care interventions attributable to the use of these technologies, and~     any relationship between these interventions and the frequency of hospitalization or ER~     visits.~      Secondary objectives include characterization of healthcare utilization, healthcare costs,~     and patient experiences with regard to the use the provided technologies.~   "
35370|NCT02593994|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent~     compared to other (drug eluting stents) DES.~   "
35371|NCT02593981|"~     As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall~     asleep and 19% complain of early-morning awakening. The implications of this sleep~     deprivation are sobering, particularly among older individuals.~      The primary goal of this study is to determine whether a palatable foodstuff which contains~     a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep~     in community-living individuals with sleep problems.~   "
35372|NCT02593968|"~     The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population~     with HPV-16 and/or HPV-18.~   "
35373|NCT02593955|"~     The purpose of this randomized, controlled interventional study is to determine the effects~     of a high intensity exercise training program on objective sleep measures, daytime~     sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's~     disease.~   "
35374|NCT02593942|"~     Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for~     this purpose. The hemodynamic stability and at the same time early emergency are the main~     goals following neurosurgery. However there is no standard for discontinuation time for~     manually controlled systems today.~      The investigators aimed to study the effect of remifentanil infusion alone for early~     emergence and hemodynamic stability during the closure period in patients undergoing~     supratentorial craniotomy.~   "
35375|NCT02593929|"~     This study will identify baseline and/or pharmacodynamic biomarkers of response to~     ruxolitinib, based upon association with quantitative change in tumor size following 14-21~     days of neoadjuvant ruxolitinib in patients with operable HNSCC.~   "
35376|NCT02593916|"~     To create a registry/database of patients who either have taken drugs that treat~     cardiovascular conditions or that have presented with cardiovascular symptoms that may be~     related to medication.~   "
35377|NCT02593903|"~     The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following~     distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary~     tract infection and complications.~   "
35378|NCT02593890|"~     A randomised interventional comparative control study will be undertaken to compare the~     THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial~     mastectomies and total mastectomies to current practice using a mixed method combining~     quantitative and qualitative instruments. 100 female participants are hoped to be recruited~     following breast surgery after a newly diagnosed breast cancer.~      This study will answer the research question:- What is the clinical and psychosocial impact~     of the THEYA Recovery Range in comparison to recommended practice during and after breast~     cancer treatment? This study will leverage the findings of a pilot study conducted by~     Applied Research Connected Healthcare (ARCH) measuring the usability of the THEYA Recovery~     Range.~      This study aims to assess the participants' experience of recovery in the immediate~     post-operative period and the psychosocial effect of THEYA Recovery Range in comparison to~     current recommended practice.~   "
35379|NCT02593877|"~     This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided~     transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma~     patients. Half of the randomised patients will receive VHA-led management of bleeding,~     whilst the other half will receive massive transfusion protocol resuscitation using~     conventional coagulation tests.~   "
35380|NCT02593864|"~     Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA~     is common among Veterans and is a leading cause of disability. The earliest stages of OA~     development, where the joint cartilage wears away, is usually painless. By the time Veterans~     experience symptoms, the OA is typically advanced and there is nothing that can be done~     except palliation until the joint is replaced with metal and plastic. If there was a blood~     test to provide early warning of cartilage wear and joint deterioration, Veterans could~     potentially be treated early enough to slow down or even prevent OA. So far, development of~     such a blood test has proved elusive. The investigators propose a new method to amplify the~     signs of cartilage wear in the blood by challenging the affected joint with a walking task.~     Similar to a cardiac stress test, this walking challenge may help to separate joints at risk~     from healthy joints. The investigators will also see if this 'OA stress test' can show if a~     simple and inexpensive load-modifying shoe can improve joint health in Veterans with early~     knee OA.~   "
35381|NCT02593851|"~     The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral~     activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection~     after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in~     infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are~     hospitalized with RSV infection.~   "
35382|NCT02593838|"~     This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily~     clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity~     and specifity of CT myocardial perfusion imaging compared to SPECT.~   "
35425|NCT02593279|"~     The aim of the study is to describe asthma phenotype with small airways dysfunction, in a~     multiparametric manner, with clinical, biological, morphological and genetic elements~     compared with asthma with proximal airways obstruction.~      The objective of this study is also to complete the clinical, immunobiological and~     morphological analysis of asthma with small airways dysfunction.~   "
35383|NCT02593825|"~     The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To~     Play (START-Play), an intervention designed to target sitting, reaching, and motor-based~     problem solving to improve development and readiness to learn in infants with motor delays~     or dysfunction. There is limited research examining the efficacy of early physical~     intervention on infants with neuromotor dysfunction. In addition, most early motor~     interventions have not been directly linked to learning, despite the research demonstrating~     an association between motor activity and cognitive skills. START-Play specifically targets~     motor skills that lead to greater physical exploration, which has been associated with~     improved problem solving and global development. A randomized controlled trial of START-Play~     will be conducted across four states to investigate the impact of the intervention on~     changes over time in sitting and reaching, subsequent changes in global cognitive~     development, and the mediating influences of motor skill changes and problem solving. The~     research team will conduct a randomized controlled trial to evaluate the impact of~     START-Play on motor development, motor problem solving, global development including~     cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will~     experience either the intervention or services as usual for 3 months, with following testing~     at three time points up until 9 months post intervention. The researchers will determine~     whether the intervention leads to improved sitting and reaching, which leads to improved~     motor-based problem solving, which leads to improved global development and problem solving.~   "
35384|NCT02593812|"~     The study determines whether standard medical care (dopamine) affects learning and retention~     of a postural stepping task in people with Parkinson's disease (PD) and whether training on~     a postural stepping task generalises to performance on an untrained postural task. Half the~     participants will train on the stepping task after they have taken their first dose of~     dopamine for the day (i.e. on medication state) while the other half will train on the~     same stepping task before taking their first daily dose of dopamine (i.e. off medication~     state).~   "
35385|NCT02593799|"~     Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In~     the early stage of liver cirrhosis, the prediction of esophageal varices is very important~     for guiding the clinical decision making of primary prophylaxis of variceal bleeding.~   "
35386|NCT02593786|"~     The purpose of this study is to determine whether nivolumab is safe and effective in the~     treatment of advanced or recurrent solid tumors in Chinese subjects.~   "
35387|NCT02593773|"~     The purpose of this phase 3 multi-center, open-label extension study is to evaluate the~     long-term safety of ACTIMMUNE® (interferon-γ 1b) in subjects with Friedreich's Ataxia (FA).~   "
35388|NCT02593760|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of vismodegib plus (+) ruxolitinib versus placebo + ruxolitinib in~     participants with intermediate- or high-risk MF. The study will be divided into 2~     components. The Phase 1b portion of the study will be started with 6-week safety run-in~     period with 10 participants who will receive vismodegib (150 milligrams [mg] orally [PO]~     once daily [QD]) + ruxolitinib (PO twice daily [BID]) for the assessment of acute safety~     events associated with this combined therapy. After getting confirmation about the safety~     and toxicity of this combination, the Phase 3 randomization portion of the study will begin~     during which approximately 84 participants will randomly assign in 1:1 ratio to receive~     either vismodegib (150 mg PO QD) plus ruxolitinib (PO BID) or placebo (PO QD) plus~     ruxolitinib (PO BID) for up to 48 weeks or until withdrawal or discontinuation, whichever~     occurs first.~   "
35389|NCT02593747|"~     To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus~     Claritin Peach Syrup 1mg/mL (ANNA Formula)~   "
35390|NCT02593734|"~     The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and~     daily contact with a nurse for people with mental health disorders in a prayer camp and~     secondly to assess whether the attitudes of the prayer camp staff toward mental health~     disorders and conventional medicines remain the same after the intervention.~   "
35391|NCT02593721|"~     The purpose of this study is to compare the effectivity of Median Nerve Neural Mobilization~     and oral Ibuprofen in treating patients who suffer cervicobrachial pain~   "
35392|NCT02593708|"~     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the~     safety and tolerability of the combination of neratinib plus paclitaxel, trastuzumab and~     pertuzumab to determine the recommended Phase II/III dose of this combination.~      Neratinib will be given once daily days 1-21 and should be taken orally with food.~     Paclitaxel and trastuzumab will be given IV on days 1, 8, and 15 out of 21 day cycles.~     Pertuzumab will be given IV every 3 weeks on day 1 out of 21-day cycles. Each cycle will be~     21 days in duration.~      Patients will continue on treatment until disease progression or intolerable toxicity.~   "
35393|NCT02593695|"~     Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates~     under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe~     Anorexia nervosa.~   "
35394|NCT02593682|"~     The purpose of this study is to provide some information (pilot data) about whether the~     study drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2)~     is associated with decreased panic symptoms in response to a carbon dioxide (CO2) challenge.~   "
35395|NCT02593669|"~     A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease~     in vision. It is the most prevalent, treatable cause of visual impairment and blindness in~     the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common~     and thought to be the most effective surgical procedure in any field of medicine. In this~     trial, the investigators aimed to evaluate the effect of cataract surgery on circadian~     rhythm and sleep as well as the effect of the blue light transmission characteristics of the~     implanted IOL on sleep.~   "
35426|NCT02593266|"~     The overall aim of this pilot study is to evaluate the acceptability and feasibility of an~     adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean~     families.~      The PIP is a family intervention directed towards strengthening family functioning and~     enhancing resilience in children of depressed parents. It comprises several modules that~     work on psycho-education and skill development within the family nucleus.~      A single-blind randomized controlled trial will be conducted with two arms, the intervention~     arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).~   "
35396|NCT02593656|"~     This study systematically quantified the effects of the Isagenix Performance System (IEPS)~     compared to a standard recommended control (C) diet both of which were combined with a~     4-day/week exercise training program on total and regional (abdominal) body composition~     (lean mass and fat mass), muscular strength and performance, flexibility, blood lipids and~     glucose, hormones, mood state and energy metabolism in 60 healthy middle-aged (25-55 years~     old) men and women following a 12-week intervention. Participants were enrolled in one of~     two cohorts:~        1. Isagenix Energy & Performance System, 2g/kg/Body Weight (BW) Protein (IEPS) (n=30)~             1. IEPS-I, n=15; consume protein feeding immediately after exercise~             2. IEPS-2, n=15; consume protein feeding 2 hours after exercise~        2. Control, 1g/kg/Body Weight Protein (C) (n=30)~   "
35397|NCT02593643|"~     Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality~     from psychiatric illnesses. In 2009, the World Health Organization listed depression as the~     leading cause of years lost due to disability worldwide. Suicide is the 9th most common~     cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics~     Canada, 2012) and the 2nd most common cause of death in young people after accidental~     deaths. This information highlights the importance of finding treatments to prevent suicidal~     deaths.~      Ketamine has been shown to provide rapid treatment response for major depressive episodes~     both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous~     infusion which persists for at least 72 hours.~      The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual~     (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT~     examining these treatments for decreasing suicidal ideation among depressed inpatients with~     major depressive disorder and bipolar depression.~      A total of 52 patients will be recruited for this trial. All subjects will be inpatients at~     Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or~     bipolar disorder type I or II currently depressed. Suicidal ideation must be present at~     baseline assessment in order to be included in the study. Thirteen subjects will be~     randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to~     ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the~     midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar~     depression will be randomized to these two treatments.~   "
35398|NCT02593630|"~     This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged~     12 to 15 years.~   "
35399|NCT02593617|"~     The objective of this study is to investigate the prevalence of energy drink, alcohol and~     substance use among university students; to explore whether there is a relationship between~     energy drink consumption and alcohol-substance use in university students or not and to~     evaluate effect of impulsiveness and sensation seeking on this relationship.~   "
35400|NCT02593604|"~     Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked~     by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI,~     Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).~   "
35401|NCT02593591|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information. Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted~     therapies in the treatment of advanced cancer and to determine the clinical outcome(Response~     rate,PFS, duration of response and overall survival )of patients with advanced cancer, the~     investigators are going to take a tumor tissue of patients and process molecular profiling~     and receive molecular profile directed treatments.~   "
35402|NCT02593578|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information. Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted~     therapies in the treatment of advanced cancer and to determine the clinical outcome(Response~     rate,PFS, duration of response and overall survival )of patients with advanced cancer, the~     investigators are going to take a tumor tissue of patients and process molecular profiling~     and receive molecular profile directed treatments.~   "
35403|NCT02593565|"~     The purpose of this study is to learn about the experience of women with vasculitis who~     become pregnant. In particular, the study will consist of several online surveys to assess~        1. each woman's vasculitis severity and pregnancy-related experiences, and~        2. pregnancy outcomes.~   "
35404|NCT02593552|"~     This pilot study was done to assess the feasibility and possible efficacy of a video~     feedback intervention to improve the safety of cognitively impaired older drivers.~   "
35405|NCT02593539|"~     This is a multi-center, non-randomised, open-label, uncontrolled, single group study to~     investigate the safety and pharmacokinetics (PK) during 84 days repeat dosing treatment with~     1000 micrograms (mcg) of inhaled GSK2269557 in addition to standard of care, in subjects~     with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110delta-activating~     mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI). To~     date GSK2269557 has been administered to healthy subjects (smokers and non smokers),~     subjects with: stable Chronic Obstructive Pulmonary Disease (COPD); subjects experiencing a~     COPD exacerbation; and subjects with persistent, uncontrolled asthma. As this study is the~     first administration of GSK2269557 to subjects with APDS, this study will provide safety,~     tolerability, efficacy and pharmacokinetic data in this patient population. Up to 20~     subjects will be enrolled into the study. The total duration of the study is approximately~     30 weeks, including pre-screening/screening and follow-up.~   "
35406|NCT02593526|"~     The proposed pilot study challenges the current widespread paradigm of discontinuing loop~     diuretics when initiating chronic HD and/or maintaining the dialysate at a constant~     temperature of 37 °C for all patients.~   "
35407|NCT02593513|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
35469|NCT02592707|"~     The purpose of this clinical phase I/II study is to investigate the safety and tolerability~     of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs).~     Secondary objectives of these study are the assessment of biodistribution, dosimetry and~     preliminary efficacy of 177Lu-OPS201.~   "
35408|NCT02593500|"~     A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO~     DETERMINE THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg~     ADMINISTERED AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT LEAST 52 HEALTHY MALES AND FEMALES~     UNDER FASTING CONDITIONS~      The study objective is to determine whether the inhaled test product, budesonide 200 µg~     (pressurized inhalation suspension) and the inhaled reference product, Budesonida Pulmictan®~     200 µg (budesonide; pressurized inhalation suspension) are bioequivalent.~      For this purpose the PK profile of budesonide will be compared after administration of a~     single dose of 600 µg (3 puffs) of each of the two inhalation formulations, under fasting~     conditions.~   "
35409|NCT02593487|"~     In many large trials, reducing low density lipoprotein (LDL) levels with rosuvastatin~     decreased the incidence of major cardiovascular events，but little attention to the effects~     of rosuvastatin on HDL level，especially on HDL subtype.~      Epidemiological evidence strongly favors the notion that the risk of cardiovascular disease~     (CVD) is inversely related to the plasma high-density lipoprotein (HDL) cholesterol~     concentration.~      HDL can be subdivided into large-sized (HDL2a, HDL2b) and small-sized subclasses (preb1-HDL,~     HDL3c, HDL3b, HDL3a) and preb2-HDL. Some studies indicate that only large HDL2a and HDL2b~     particles make HDLs possess anti-atherogenic functions.~      The investigators assume that rosuvastatin could play the role of anti-atherosclerosis~     though the levels of HDL2a、HDL2b increased.~   "
35410|NCT02593474|"~     The purpose of this open-label pilot study is to determine the tolerability and~     applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in~     individuals age 16-21 (older youth) with opioid use disorder. Outpatient treatment will~     consist of a 7-day outpatient detoxification / naltrexone induction procedure followed by~     8-weeks of treatment with Vivitrol.~   "
35411|NCT02593461|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
35412|NCT02593448|"~     The purpose of the present study is to assess, by near infrared spectroscopy with INVOS~     oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on~     tissue saturation in thenar muscle.~      The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on~     tissue saturation.~      It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will~     receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at~     the following time points: 30 minutes after anaesthesia induction, directly after~     sternotomy, 20 and 40 minutes after aortic cross-clamping, 20 minutes after aortic~     cross-clamp removal, and 45 minutes after weaning of cardiopulmonary bypass (CPB).~      Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's~     test.~   "
35413|NCT02593435|"~     Purpose:~        1. Screening of large samples is to search the gene mutation of the breast cancer~          susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.~        2. To build the breast cancer BRCA1/2 mutation database of Chinese group.~        3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.~   "
35414|NCT02593422|"~     This online study aims to understand whether writing about one's experiences with ovarian~     cancer may be beneficial for psychological and physical wellbeing in women with a history of~     ovarian cancer. Investigators are also interested in studying how certain individual~     characteristics may impact the effectiveness of writing. Participants will be asked to~     complete an initial survey (15 min), followed by writing about their experiences with~     ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final~     survey (10 min) will be completed one month afterwards.~   "
35415|NCT02593409|"~     Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving~     antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this~     possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one~     year.~   "
35416|NCT02593396|"~     The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion~     hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone~     maintenance therapy.~   "
35417|NCT02593383|"~     evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in~     treatment of chinese patients with acne.~   "
35418|NCT02593370|"~     The main objective of the trial is to complete a double-blinded randomized controlled trial~     with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift~     technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel~     Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator~     nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.~   "
35419|NCT02593357|"~     The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic~     obstructive pulmonary disease) patients and the relationship between the peripheral~     endothelial function and the pulmonary function.~   "
35420|NCT02593344|"~     The aim of the study is to assess the peripheral endothelial function in adult asthmatic~     patients and the relationship between the peripheral endothelial function and the pulmonary~     function.~   "
35421|NCT02593331|"~     This study will evaluate the safety and tolerability profile of BFKB8488A following~     subcutaneous (SC) administration in overweight and obese subjects (body mass index [BMI]~     27-40 kg/m^2) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A~     will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose~     cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to~     higher dose cohorts.~   "
35422|NCT02593318|"~     The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at~     doses of up to 2 grams per day in people with Alzheimer's disease (AD).~   "
35423|NCT02593305|"~     The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate~     supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity,~     and blood pressure responsiveness to a variety of physiological stressors in older healthy~     adults. We will also examine the effect of dietary nitrate supplementation on measures of~     central artery stiffness and aortic blood pressure in older adults.~   "
35470|NCT02592694|"~     This is a randomized, double blind, placebo controlled study of intracoronary cocktail~     injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation~     myocardial infarction patients treated with primary angioplasty.~   "
35427|NCT02593253|"~     This single-blinded, cluster randomized control trial will assess the effectiveness of an~     audit and feedback bundle on internal medicine physician performance on selected quality~     metrics. The feedback bundle includes an electronic dashboard and weekly feedback rounds in~     which physicians will review their performance. The control arm will undergo audit and~     feedback per the current system, which is biweekly feedback emails with performance.~   "
35428|NCT02593240|"~     Worksites offer attractive locations for reducing the national prevalence of overweight and~     obesity. Interventions that are both effective and sustainable for producing long-term~     changes in health and employee wellness are urgently needed. In an 18-month worksite~     randomized controlled trial in 12 worksites this study will test two lifestyle approaches~     designed to facilitate behavior modification for achieving long-term improvements in health~     and quality of life. Worksites randomized to the immediate intervention arm will receive the~     two on-site wellness programs and the randomized control sites will participate in outcomes~     assessments for the initial 6 month period after which participants will receive vouchers to~     participate in the program of their choice. The primary focus of the worksite wellness study~     is to identify ways to improve health related quality of life, with a particular focus on a~     decrease in cardiometabolic risk factors, including weight, improved weight-related~     wellness, and improved energy level in work and life. The combination of 2 interventions~     will be tested against the control condition in an intention to treat model and with a~     completers analysis.~   "
35429|NCT02593227|"~     This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate~     Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or~     without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant~     or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).~   "
35430|NCT02593214|"~     General objective:~      To assess the performance and safety profile of a novel innovative design of female condom~     (Wondaleaf®) among healthy married women.~      Specific objectives :~        -  To determine the failure rate of Wondaleaf®, in terms of clinical breakage,~          non-clinical breakage, invagination, misdirection, and slippage.~        -  To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and~          their spouses.~        -  To assess the safety profile of Wondaleaf®.~   "
35431|NCT02593201|"~     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in~     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent~     peritonitis remains the major cause of peritoneal failure. A recent study showed that an~     elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of~     antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We~     hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD~     effluent bacterial DNA fragment levels could prevent the development of relapsing and~     recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD~     peritonitis. After inform consent, they will be randomized to receive one additional week of~     the effective antibiotic treatment (the Preemptive Treatment Group) or no additional~     treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to~     the completion of antibiotics for the measurement of bacterial DNA fragments. All patients~     will be followed for 6 months after completion of antibiotic therapy for the development of~     relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy~     of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent~     peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic~     treatment.~   "
35432|NCT02593188|"~     The purpose of the proposed study is to acquire additional data (including the assessment of~     anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed~     treatment regimens and treatment administration in routine clinical practice.~   "
35433|NCT02593175|"~     The goal of this clinical research study is to learn if receiving 4 cycles of an~     experimental chemotherapy combination before surgery can help to shrink or slow the growth~     of tumors before they are removed through surgery. The safety of this combination will also~     be studied.~   "
35434|NCT02593162|"~     Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir~     and TD-6450 in combination with Ribavirin for a 12-week treatment duration in~     treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.~   "
35435|NCT02593149|"~     To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard~     HD end caps compared to the Tego® connector with the Curos® for Tego disinfecting port~     protector.~   "
35436|NCT02593136|"~     This study evaluates the program effectiveness of home fortification along with infant and~     young child feeding (IYCF) counseling as a strategy to address anemia and complementary~     feedings gaps in a program setting of the Integrated Family Health Initiative being~     implemented by CARE India (a non-profit organization) in partnership with the Government of~     Bihar. The study also seeks to assess the field level worker experience with counseling and~     dissemination of home fortification products.~   "
35437|NCT02593123|"~     Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients~     receiving the investigational regimen.This is a randomized phase II clinical trial,~     comparing two different dosing schedules of mycophyenolate mofetil for graft versus host~     disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse,~     GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study~     arms will be performed based on T cell counts at day 60.~   "
35438|NCT02593110|"~     The TELEX trial will establish whether telmisartan alone improves walking performance in~     people with peripheral artery disease (PAD). The TELEX trial will also determine whether~     telmisartan plus supervised exercise improves walking performance more than either therapy~     alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 240~     participants with PAD randomized to one of four arms: Group A: telmisartan + supervised~     exercise therapy; Group B: telmisartan + a no exercise control group; Group C: placebo +~     supervised exercise therapy; and Group D: placebo + a no exercise control group.~   "
35489|NCT02592447|"~     The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted~     Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on~     tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy~     relative to usual care only in a small-scale randomized controlled trial.~   "
35439|NCT02593097|"~     Migraine is the third most prevalent disease in the world. Preventive treatment is indicated~     in about 40% of individuals with episodic migraine. Although 4 treatments are approved by~     the US Food and Drug Administration for prevention of episodic migraine, none were designed~     to prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As~     a result, less than 1/3 of migraine sufferers with who are candidates for prevention receive~     drug treatment and of those who are treated, more than 85% have discontinued the preventive~     drug within one year. Migraine pain is associated with the activation and sensitization of~     specific receptors involved in pain-promoting pathways. Metformin, which is a widely~     available, well-tolerated anti-diabetic medication, can downregulate pain-promoting~     pathways. Metformin has demonstrated positive results in animal models of migraine in the~     laboratory. Given the longstanding use and established safety record of metformin, the~     investigators will evaluate the safety and efficacy of metformin for preventive treatment of~     high-frequency episodic migraine in a randomized, double-blind, placebo-controlled,~     crossover trial.~   "
35440|NCT02593084|"~     Exercise programs, particularly resistance training programs using weights or resistance~     bands, can help improve or maintain mobility and function in older adults, preserve~     independent living, and improve quality of life. This study will examine the safety and~     feasibility of a novel, higher intensity resistance training program in older adults, and~     compare the effects with standard care, lower intensity training. It is anticipated that~     both programs will be safe and feasible, but higher-intensity training will lead to greater~     improvements in quality of life, mobility and strength, which are part of the physical~     phenotype definition of frailty.~   "
35441|NCT02593071|"~     This study will enroll subjects who received the RSV F vaccine or placebo in the earlier~     study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a~     second season. This design will permit evaluation of the safety and immunogenicity of~     revaccination in a second RSV season, and the safety and immunogenicity of revaccination~     over two years.~   "
35442|NCT02593058|"~     This study evaluates the addition of a 8 session psychological program, called Positive~     Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with~     schizophrenia. Half of the participants will receive their usual treatment and PEPS in~     combination, while the other half will receive usual treatment only.~   "
35443|NCT02593045|"~     The primary objective of this first in human study is to assess the safety and tolerability~     of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with~     relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a~     Maximum Tolerated Dose (MTD).~   "
35444|NCT02593032|"~     Medication adherence is defined as the extent to which a patient takes his or her medication~     as prescribed by their healthcare provider. One third to one half of all patients in the~     United States do not take their medication as directed, resulting in nearly $100B in~     avoidable hospital costs per year. Recent efforts to improve medication adherence in~     patients with multiple comorbidities have turned to case management and disease management~     programs. Connected monitoring devices offer an alternative- or supplement- to frequent~     nurse visits and outreach. These devices enable frequent monitoring and intervention but can~     also generate large volumes of data that can be difficult for care teams to manage. The~     present study explores the use of one such device- a technology-enabled, connected pillbox.~     Given the continued emphasis on bending the cost curve in US healthcare, clinical validation~     of tools that may improve the management of costly chronic diseases, such as diabetes, is~     essential.~   "
35445|NCT02593019|"~     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein~     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2~     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.~      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase~     of the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the~     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).~      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced~     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic~     cytotoxic effects when administered in combination with various DNA damaging agents that~     have divergent mechanisms of action. Therefore, the primary objective of the clinical~     development of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic~     agent (or combination of agents) for treatment of advanced solid tumors.~      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is~     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause~     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA~     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775~     will have independent anti-tumor activity in the absence of added chemotherapy.~      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human~     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase~     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may~     selectively sensitize p53-deficient cells.~      One hundred percent of Small cell lung cancer has TP53 mutation, therefore we can expect~     that most of Small cell lung cancer have lost G1 checkpoint and has high probability of WEE1~     dependency for proper DNA repair and cell cycle progression. For this reason, Small cell~     lung cancer could be a good clinical trial target disease for WEE1 inhibitor.~   "
35446|NCT02593006|"~     STOP-JIA is a PCORI funded prospective observational study which will compare the clinical~     effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis &~     Rheumatology Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in~     new-onset polyarticular JIA (pJIA) patients to answer the critical question of when is the~     best time to begin biologic medications to achieve the optimal clinical and patient reported~     outcomes. Because the CARRA Registry will be used for data collection, all patients will be~     enrolled in the CARRA Registry. The standard of care treatments are chosen by the treating~     physician and patient/caregiver and are not randomized.~   "
35447|NCT02592993|"~     Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars~     treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.~   "
35457|NCT02592863|"~     Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular~     dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and~     older. The symptoms have a severe impact on affected individuals with detrimental effects on~     work, travel, social and family life. These patients see doctors often with no relief in~     their symptoms.~      The most promising help for these patients is to use medication that will increase blood~     flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular~     blood flow.~   "
35490|NCT02592434|"~     Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.~   "
35491|NCT02592421|"~     In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in~     plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP~     following SGLT2 inhibition.~   "
35448|NCT02592980|"~     Background: Time in therapeutic range (TTR) is a measurement of quality of warfarin therapy~     and lower TTR values (<50%) are associated with greater risk of thromboembolic and bleeding~     events. Recently, the investigators developed a pharmacogenetic-based warfarin dosing~     algorithm specifically calibrated for a Brazilian patient sample. The newly developed~     algorithm was shown to be more accurate for individuals from the Brazilian population than~     algorithms developed from international samples. The aims of this study are: to evaluate the~     impact of a genetic-based algorithm, compared to traditional anticoagulation, in the time to~     achieve the therapeutic target and in TTR percentage; and to assess the cost-effectiveness~     of genotype-guided warfarin dosing in a specific cohort of patients with low TTR (<50%) from~     a tertiary cardiovascular hospital. Methods/Design: The investigators will recruit 300~     patients with TTR<50% based on the last three INR values. At the first consultation,~     patients will be randomized into two groups: TA (Traditional Anticoagulation) group and PA~     (Pharmacogenetic Anticoagulation) group. For the first group, the physician will adjust the~     dose according to current INR value and, for the second group, a pharmacogenetic algorithm~     will be used. At the second, third, fourth and fifth consultations (with an interval of 7~     days each) INR will be measured and, if necessary, the dose will be adjusted based on~     guidelines. Afterwards, patients who are INR stable will begin measuring their INR in 30 day~     intervals; if the patient´s INR is not stable, the patient will return in 7 days for a new~     measurement of the INR. The main outcomes will be the time to achieve the therapeutic target~     and the percentage of TTR at 4 and 12 weeks. In addition, as a secondary end-point,~     pharmacoeconomic analysis will be carried out. Discussion: With a sample size of 150~     patients for each arm separately, the study will have a power of 93% to observe a difference~     of 10% between TTR means of the TA and PA groups. This randomized study will include~     patients with low TTR and it will evaluate whether a population-specific genetic algorithm~     might be more effective than traditional anticoagulation for a selected group of poorly~     anticoagulated patients.~   "
35449|NCT02592967|"~     The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of~     JNJ-64041757 a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in~     which two virulence genes, which encode molecules that help cause disease, have been~     removed) when administered intravenously to participants with advanced (Stage IIIb) or~     metastatic (Stage IV) NSCLC (adenocarcinoma).~   "
35450|NCT02592954|"~     Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every~     night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the~     end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase~     chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.~   "
35451|NCT02592941|"~     The expanded access program will provide access to treatment with deflazacort in children,~     adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise~     unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new~     drug application is under preparation and review. Enrollment is open to all eligible~     patients.~   "
35452|NCT02592928|"~     Background/Aims There is evidence indicating that deployment of forced spirometry (FS)~     testing in a collaborative scenario, encompassing respiratory specialists and community~     professionals, generates healthcare efficiencies. The study describes the roadmap for~     regional implementation of the FS program in Catalonia (ES), from January to December 2016.~      Methods/Design Firstly, the FS program will be deployed in three healthcare sectors (514 k~     inhabitants), following Plan-Do-Study-Act iterative cycles, using the Model for Assessment~     of Telemedicine for evaluation purposes. Thereafter, regional deployment of the FS program~     (7.5M inhabitants) will be conducted. The third step considers: evaluation of~     transferability, preparation for data analytics and recommendations for long-term assessment~     of outcomes. Main components of the FS program are: i) Automatic quality testing; ii)~     Standardized data transfer to a shared electronic health record; iii) Elaboration of~     individual FS reports including historical results; and, iv) Clinical decision support~     systems providing access to the FS report, and to remote support upon request.~      Discussion/Conclusions The project constitutes the first attempt to scale-up a collaborative~     scenario for FS testing that will open new avenues for longitudinal lung function~     assessment. Moreover, the setting shows high potential for transferability to different~     sites and to other diagnostic procedures.~   "
35453|NCT02592915|"~     The purpose of this study is to assess the effect of IV clonidine administration on lower~     limb spinal motoneuron excitability during standardized total intravenous anesthesia~     (propofol and remifentanil).~   "
35454|NCT02592902|"~     The purpose of the study was to determine, whether patients with recurrent respiratory~     papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with~     laryngeal cyst (control group).~   "
35455|NCT02592889|"~     Functional mitral regurgitation (FMR) is a common finding in patients with dilated~     cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a~     relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac~     resynchronization therapy (CRT) has been shown to be effective in patients with dilated~     cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical~     improvement and reduced mortality. Importantly, 38% of patients with clinical indication for~     CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the~     persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an~     independent predictor of no clinical response. In these patients, surgical FMR correction is~     frequently turned down as a result of a high surgical risk. Percutaneous repair of the~     mitral valve with the MitraClip system has demonstrated promising results in patients with~     dilated cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT~     and FMR ≥2, Auricchio et al showed significant clinical improvement with LVEF recovery and~     reduction in left ventricle (LV) volumes after MitraClip. The absence of randomization, the~     retrospective nature of the study and the subsequent selection biases were however major~     limitations that impeded solid conclusions. The objective of the present study is to assess~     the efficacy and safety of the MitraClip system in non-responders to CRT and FMR ≥2.~   "
35456|NCT02592876|"~     The purpose of this randomized, open-label study is to evaluate the safety and efficacy of~     denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when~     compared to RICE alone in the treatment of patients with relapsed or refractory diffuse~     large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also~     be candidates for autologous stem cell transplant. Patients will be randomly assigned in a~     1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE~     or RICE alone. The study will assess whether there is a difference between the 2 groups in~     the side effects that are reported and the number of patients who achieve complete remission~     at the end of their study treatment.~   "
35467|NCT02592733|"~     This is an observational trial to determine if use of fusion imaging in infrarenal~     endovascular aneurysm repair will decrease the radiation dose and improve patient safety for~     this procedure.~   "
35468|NCT02592720|"~     This is a randomized, single blind, controlled study of intracoronary cocktail injection~     before fractional flow reserve (FFR) measurement when guiding percutaneous coronary~     intervention (PCI) in patients with acute coronary syndrome (ACS).~   "
35458|NCT02592850|"~     Tension-type headache (TTH) is a very common primary headache disorder, with important costs~     for both patients and society. Often these patients are not willing to take prophylactic~     medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT)~     is an interesting option in such field, since it is characterized by a low profile of side~     effects.~      In this study the investigators will assess the efficacy of OMT (semi-structured evaluation~     and black box treatment) in frequent Episodic TTH (ETTH) in an outpatient setting.~     Preliminary data for power calculation are already available (Rolle et al. 2014), and the~     investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind,~     sham-controlled design.~   "
35459|NCT02592837|"~     Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an~     excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides~     needle aspirate samples which are often adequate for cytological examination only. More~     advanced histopathological and immunocytopathological assessment of tissue samples, which is~     particularly important in the diagnosis and staging of cancer, is often not possible with~     the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration~     needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and~     more flexibility at the distal end, allowing better access to some lymph nodes stations.~     This needle can be passed down an EBUS scope and can hypothetically circumvent the~     deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological~     assessment rather than cytological assessment alone.~      This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve~     the diagnostic yield of EBUS sampling procedures compared to the use of the conventional~     TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat~     procedures or more invasive surgical biopsies, without causing an increase in complication~     rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will~     be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional~     procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250~     patients over a 24 month period.~   "
35460|NCT02592824|"~     The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery~     reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients~     undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for~     coronary artery bypass surgery of at least two vessel disease or left main stenosis with or~     without concomitant procedure and considered to be at moderate to high surgical risk~     preoperatively with regard to postoperative heart failure will be studied. The primary~     endpoint is postoperative increase of NT-proBNP from the day before surgery to the third~     postoperative day.~   "
35461|NCT02592811|"~     Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in~     approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical~     lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones.~     Because of inconstant success, high cost, and length of procedure, an alternative method was~     proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the~     safety of ESLBD is accepted in all recent published studies, it remains controversial wether~     ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones.~     Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.~      The purpose of this prospective comparative multi center randomized study is to evaluate the~     superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large~     bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic~     strategy.~   "
35462|NCT02592798|"~     The purpose of this study is evaluate if abatacept is effective and safe in decreasing the~     level of protein loss in the urine in patients with excessive loss of protein in the urine~     (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal~     change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis.~     Another kidney biopsy will not be required as part of the study. Candidates must have failed~     or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy~     must include corticosteroids and at least one other drug. Candidates can be adults and~     children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.~   "
35463|NCT02592785|"~     Primary objectives of this study are to assess the safety and tolerability of BAY 1163877 in~     Japanese subjects with refractory, locally advanced or metastatic solid tumors and to~     characterize the PK of BAY 1163877~   "
35464|NCT02592772|"~     This study examines the potential effect of reducing nicotine content or menthol or both in~     men. It will also examine whether there are gender differences in manipulating tobacco~     flavors and nicotine concentrations in cigarettes on smoking behavior.~   "
35465|NCT02592759|"~     The purpose of this study is to evaluate the therapeutic effects of smart glove which is~     motion-based program designed for upper extremity rehabilitation after stroke.~   "
35466|NCT02592746|"~     Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC,~     in the last decade there was no major improvement of hormonal therapy specifically for~     premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and~     the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal~     women is much higher, in Asia, including Korea.~      Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine~     derivative and has shown high efficacy and low toxicity in metastatic breast cancer~     patients. Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed~     marked advance in hormone receptor-positive MBC in the post-menopausal setting. After a~     median follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial~     suggest that the combination of PD-0332991 with letrozole is superior to letrozole alone,~     and improved objective response and disease control rates (52% vs 32% and 76% vs 47%,~     respectively) in patients treated with the combination. These remarkable results may~     contribute to have much benefit with endocrine therapy for premenopausal women. Most~     importantly, recent PALOMA-3 trial revealed superior results of adding palbociclib to~     fulvestrant (median PFS 9.2 vs 3.8 months, P<0.001).~      Based on these rational backgrounds, the purpose of this phase II study is to assess the~     safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in~     combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive~     advanced breast cancer patients~   "
35471|NCT02592681|"~     This study is designed to make comparisons between acupuncture and acupressure for~     preventing menstrual migraine (MM). Whether acupuncture is superior to acupressure is the~     most interesting point of this study. First of all, females will be screened for~     eligibility. Then, all participants who meet the inclusion criteria will be asked to keep a~     headache migraine diary for three months as baseline data. The diaries will then be~     collected before the first treatment. Then, all the participants will receive the~     corresponding interventions on the eighth, fifth and second days before the estimated first~     day of menstruation (determined individually from the diaries) in each month for three~     months (menstrual cycle), making a total of nine treatment sessions. After the whole~     treatments, there will be a three-month follow-up period. All the participants will be asked~     to complete the headache diaries every month from baseline to the end of the study. The~     diaries recording data from the fourth to the ninth month will then be collected at the end~     of the ninth month for the second time indicating the end of the study for the participants.~     In case of an acute migraine attack, participants will not be restricted from using normal~     medications.~   "
35472|NCT02592668|"~     This is a feasibility study to test the use of epidural stimulation to restore volitional~     function previously lost due to spinal cord injury.~      Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic,~     have shown that direct electrical stimulation of the spinal cord increases the excitability~     of spared neuronal connections within the site of injury, thereby enhancing signal~     transmission and allowing recovery of previously lost volitional function. Recently,~     epidural electrical stimulation of the lumbosacral spinal cord in four individuals with~     spinal cord injury (SCI) has restored motor and autonomic function below the level of~     injury. Despite positive results, further translational research is needed to validate these~     findings. The goal of this proposal is to perform epidural stimulation to restore volitional~     function in patients with SCI. In two patients, we will implant an epidural stimulator onto~     the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a~     structured program of daily physical rehabilitation, treadmill step training, and epidural~     stimulation to recover motor, sensory, and autonomic function.~   "
35473|NCT02592655|"~     This cross-over study of twenty five healthy human subjects will utilize two active control~     devices, and two different widths of the investigational device. One active control is~     representative of the usual care tourniquet applied in hospital settings. The second active~     control is a windlass tourniquet representative of the pre-hospital and military usual care~     tourniquet device. Two inch and four inch widths of the investigational device will be~     evaluated. The purpose of this study is to characterize and compare investigational and~     control tourniquet safety and efficacy. All tourniquets will be applied to the upper thigh.~     Efficacy data is provided by the presence or absence of popliteal flow when assessed with~     ultrasound. Mapping of interface pressures between the skin and the tourniquet will provide~     safety data. A minimum washout of five minutes will be allowed between tourniquet~     applications. All interventions will be applied in one visit. No follow up visit is~     anticipated.~   "
35474|NCT02592642|"~     Arthritis of the spine causes narrowing of the spinal canals and compression of the spinal~     nerves traveling into the legs, limiting walking ability. The vast majority of individuals~     with arthritis of the spine are not suited for surgery and most receive non-surgical~     treatment. However, we do not know what non-surgical treatments are effective in improving~     walking in these people. The purpose of our research is to test four new treatments for~     arthritis of the spine to see if they can improve walking ability. Each treatment approach~     focuses on the changes that occur in the spine and the whole person as a result of the~     arthritis that directly or indirectly impacts the ability to walk and perform usual daily~     activities. Because arthritis of the spine is a chronic condition usually does not go away,~     it is important that people acquire the knowledge, skills, and tools to manage their~     condition on their own. The treatments that investigators plan to test as part of this~     research proposal are aimed at achieving this goal. However, before the investigators can~     promote the use of these treatments they need to formally test them using strict scientific~     methods to make sure they do more good than harm. The four treatments include 1) a six week~     training program referred to as Boot Camp for Stenosis which provides one-on-one training~     on exercise and self-management strategies 2) a patient educational workbook and video on~     how to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve~     pain when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on~     the nerves while walking. The plan is to assess the change in walking distance using the~     various treatments and assess what impact the treatments have on peoples' overall function~     and quality of life. Innovative treatment approaches with a long term perspective are~     urgently needed to deal with the growing number of people with arthritis of the spine who~     are disabled. It is likely that there is not one solution to this problem - many people will~     require more than one type of treatment, but an important first step is to determine which~     treatments are effective, then tailor the treatments to the needs of each person.~   "
35475|NCT02592629|"~     The specific aim of this prospective study is to determine whether local anesthetics prior~     to subacromial steroid injections reduce pain and consequently if they are cost-effective in~     the treatment for shoulder pathology.~   "
35476|NCT02592616|"~     Four months of interval walking (IW) training results in substantial weight loss in~     opposition to energy-expenditure matched continuous walking (CW) training. The reason for~     this is unclear.~      This study will assess if IW leads to greater exercise-induced suppression of appetite and~     ad libitum food intake compared to CW and no exercise.~      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled~     study, where each subject will undergo three trials. Trials will be identical except the~     following interventions:~        1. One hour of rest (CON)~        2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow~          walking; IW)~        3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.~      After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal),~     with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin,~     Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised~     ad-libitum meal test will be served and intake will recorded. Free-living energy intake via~     food records will be assessed during the following 32 hours.~   "
35477|NCT02592603|"~     Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS~     patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic~     surveillance in specialized centers. Proximal serrated lesions are endoscopically~     challenging to detect due to their unremarkable morphology. Endocuff is a novel device~     comprised of a cap with a row of finger-like projections with a unique dynamic shape that~     help to flatten mucosal folds during withdrawal of the instrument in order to improve~     detection of lesions. Recent studies have reported an increase of detection rate and mean~     per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard~     Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted~     Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to~     Standard Colonoscopy in a randomized fashion~   "
35478|NCT02592590|"~     The purpose of this study is to determine the individual and combined effectiveness of two~     smartphone-based tools for improving physical activity. The first is an individualized and~     guided goal-setting module, and the second uses points, levels, and badges to provide~     instant positive feedback throughout the program. It is hypothesized that both components~     will be effective, and greater effects will be noted for those receiving both components.~   "
35479|NCT02592577|"~     This first time in human study is intended for men and women at least 18 years of age who~     have advanced lung cancer which has grown or returned after being treated. In particular, it~     is a study for subjects who have a blood test positive for HLA-A*0201 and/or HLA-A*0206~     protein and a tumor test positive for MAGE A10 expression (protein or gene). The study will~     take the subject's T cells, which are a natural type of immune cell in the blood, and send~     them to a laboratory to be modified. The changed T cells used in this study will be the~     subject's own T cells that have been genetically changed with the aim of attacking and~     destroying cancer cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion. The purpose of this study is to test the~     safety of genetically changed T cells and find out what effects, if any, they have in~     subjects with lung cancer. The study will evaluate three different cell dose levels in order~     to find out the target cell dose. Once the target cell dose is determined, additional~     subjects will be enrolled to further test the safety and effects at this cell dose.~      Subjects will be seen frequently by the Study Physician right after receiving their T cells~     back. Subjects will then be entered into a long-term follow up in order to monitor the~     subject. Subjects will be seen every 6 months by their Study Physician for the first 5 years~     after the T cell infusion. If the T cells are found in the blood at five years, then the~     subjects will continue to be seen once a year until the T cells are no longer found in the~     blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years,~     then the subject will be contacted by the Study Physician for the next 10 years.~   "
35480|NCT02592564|"~     This study evaluates underlying psychological and biological mediators in Internet-delivered~     cognitive behavior therapy for adults with social anxiety disorder.~   "
35481|NCT02592551|"~     The objective of this study is to determine whether MEDI4736 or combination therapy with~     MEDI4736 + tremelimumab are associated with favorable alterations of the intratumoral~     immunologic environment in subjects undergoing resectional surgery for Malignant Pleural~     Mesothelioma MPM.~   "
35482|NCT02592538|"~     Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a~     beneficial treatment option for palliation of malignant biliary strictures. RFA uses a~     high-frequency alternating current to generate heat and achieve coagulative necrosis when in~     contact with tissue. Within the bile duct, RFA appears to be safe and may result in~     decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile~     duct obstruction rather than to decrease the tumor. Recently orally available~     chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients~     with bile duct adenocarcinoma. To date, little is known about the role of the addition of~     systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate~     the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.~   "
35483|NCT02592525|"~     This study will train health providers in home care teams across Quebec in shared decision~     making about the decision to stay at home or move to another location. This decision is one~     of the toughest for older Canadians. Decisions that are informed, shared and supported~     produce better results. An interprofessional approach to shared decision making is when~     older persons and their caregivers are supported by not just one but by all the~     professionals involved in their care.The impact of the training program in interprofessional~     shared decision making (IPSDM) above that of the passive dissemination of a decision guide~     will be assessed by measuring to what extent older persons caregivers say they took active~     part in the decision-making process.~      Other outcome measures will be:~      i) what option they chose, whether they feel conflict or regret about their decision, and~     the burden of care they feel; ii) the quality of life of clients;~   "
35484|NCT02592512|"~     This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted~     Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure~     Support (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4~     hours. Afterwards they will be subjected to a semi-structured interview where they will be~     asked to compare the two modes. The hypothesis is that NIV-NAVA will correct patients power~     of Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable~     for the patients.~   "
35485|NCT02592499|"~     The study is a prospective, randomized, non-blinded, national, multi-center study. The study~     will consist of the assignment of eligible patients to treatment with either a HeartMate III~     (HM III) left ventricular assist device system or to pharmacological treatment (optimal~     medical management, OMM) according to current guidelines. One hundred and forty (140)~     patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III~     and OMM.~   "
35486|NCT02592486|"~     The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and~     pneumococcal vaccine was unknown. The purpose of present study is to compare the~     immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine~     with that of separate administration.~   "
35487|NCT02592473|"~     The purpose of this project is to evaluate the safety, efficacy, and feasibility of~     performing prostatic artery embolization (PAE) using endovascular techniques and particle~     embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic~     hyperplasia (BPH).~   "
35488|NCT02592460|"~     Animal studies have shown that the level of pain sensitivity is highly dependent on the~     amount of polyamines in food. This fundamental observation of a nutritional approach to pain~     led the authors to develop diets completely depleted in polyamines whose anti-nociceptive~     properties have been confirmed in animals.~      Postoperative pain after foot surgery are currently fairly well controlled but at the cost~     of a high consumption of grade II analgesics which is associated with a high rate of side~     effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in~     polyamines may have an additive effect on pain control and reduce the consumption of level 2~     analgesics.~      The objective of this study is to show the efficacy of a polyamines-poor diet on~     postoperative pain in ambulatory surgery of the foot.~   "
35492|NCT02592408|"~     This is a randomized controlled trial to assess the efficacy and safety of the national~     malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine -~     pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and~     the hematologic effect of 14 days routine primaquine based radical cure in patients~     suffering from a P. vivax or mixed infection.~   "
35493|NCT02592395|"~     The purpose of this study is to see how well electrochemotherapy works at treating people~     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines~     electroporation and chemotherapy administration. Electroporation uses an electric current to~     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher~     concentration of administered chemotherapy agent. This study will test the safety and look~     at the effect of electrochemotherapy in the treatment of stage III pancreatic~     adenocarcinoma. This study will also help to find the safest and most effective amount of~     electroporation voltage to apply to this type of tumor.~   "
35494|NCT02592382|"~     Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children~     throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in~     conductive hearing loss that can cause speech, language, academic, and social developmental~     delays.~      Complementary and alternative medicines are being widely used for prevention of AOM.~      Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for~     preventing dental caries and AOM in children. It is commercially available in chewing gums,~     syrups and toothpastes washes, and other products. Xylitol was shown in several studies to~     prevent the culture if bacteria in the nasopharynx and oral cavity. It was proven to~     eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system.~      In this study the investigators aim to test the yield of Xylitol nasal spray compared to~     isotonic saline spray in prevention of recurrent AOM.~   "
35495|NCT02592369|"~     Prospective, single arm, multi-center, observational, post market study to document the~     clinical and device performance outcomes of the Evolut R system used in routine hospital~     practice in a large patient cohort for the treatment of symptomatic native aortic valve~     stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure~     necessitating valve replacement.~   "
35496|NCT02592356|"~     The goal of this clinical research study is to learn about possible weight, muscle, and/or~     fat loss in patients receiving cabozantinib or lenvatinib.~   "
35497|NCT02592343|"~     The primary goal is to study patients with recurrent Clostridium difficile Infection (CDI)~     treated with lyophilized Fecal Microbiota Transplantation (FMT) in an open-labelled~     controlled trial. The treatment failure rate will be evaluated as defined by the persistence~     of diarrhea and a positive C. difficile toxin assay. The safety, clinical response, and~     relapse rate in patients will be assessed.~   "
35498|NCT02592330|"~     The main aim of the study is to determine the safety and feasibility of a cultivated~     autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem~     cell deficiency.~   "
35499|NCT02592317|"~     The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the~     pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9,~     CYP2C19, CYP2C8) and transporter (P-gp and BRCP) substrates in participants with~     castration-resistant prostate cancer (CRPC).~   "
35500|NCT02592304|"~     Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by~     DECT in operation specimens from rectal resection for cancer. sub project 2: Primary~     endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC~     specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool~     for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as~     reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive-~     and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate~     the value of the gold standard for the use of imaging methods for the description of the~     lymph node, validated by histopathology. Secondary: to determine the value of tumor~     diagnostics using DECT.subproject 4: To assess the value of DECT as imaging tool for~     diagnosing response to chemo radiotherapy of malignant lymph nodes.~   "
35501|NCT02592291|"~     This study will assess the benefits of using mobile health system designed for individuals~     with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral~     Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and~     self-management skills compared to those who receive standard of care only.~   "
35502|NCT02592278|"~     The aim of this study is to determine the effectiveness of fluoride varnishes in the~     prevention of dental caries lesions in erupting permanent first molars, in high-risk~     patients. Using as reference ICDAS criteria, when the success means that the surface~     maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.~      Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental~     caries.~      Study design: It proposed an experimental design randomized into 3 groups according to the~     frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month;~     Group C: positive control).~   "
35503|NCT02592265|"~     The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a~     new point of view that includes consequences of disability on Quality Of Life (QOL), social~     participation and capabilities of patients and caregivers. To the investigators' knowledge,~     there is currently no data including intangible costs related to caregivers and calculating~     the overall economic cost of Multiple Sclerosis, particularly, in France.~   "
35504|NCT02592252|"~     Violence against women and girls is increasingly recognized as a major global public health~     and development concern. However, evidence on what forms of intervention should be~     prioritised is severely lacking. A cluster randomized controlled trial (The Intervention~     with Microfinance for AIDS & Gender Equity - IMAGE Project) in rural South Africa combined a~     group-based microfinance intervention with a participatory gender and HIV training~     curriculum for loan participants and showed that, over a two-year period, levels of physical~     and/or sexual partner violence experienced by participants in the past year were reduced by~     55%.~      The overall goal of the current study is to design and implement a cluster randomized~     controlled trial to assess the impact on intimate partner violence of: 1) combining~     participatory gender training with microfinance for women in existing microfinance loan~     groups, and 2) a participatory gender training programme for women (not receiving~     microfinance) and their male partners.~   "
35506|NCT02592226|"~     The ventilation of the patient under general anesthesia is an old problem and extensively~     studied, especially in visceral surgery, higher risk of postoperative complications. Studies~     have recently shown the impact of a lung-protective ventilation in visceral surgery, however~     obese patients are often excluded, and alveolar recruitment maneuver has never been studied~     independently.~      The investigators are conducting a randomized controlled prospective study to investigate~     the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing~     bariatric surgery.~      The objective is to show the reduction in dyspnea, oxygen dependency: reflection of~     atelectasis and the incidence of postoperative complications.~   "
35507|NCT02592213|"~     Breast cancer is the most common cancer type among women. Treatment in many cases involves~     axillary lymphadenectomy followed by radiation therapy. This increases the risk of~     lymphedema development which occurs in up to 30% of such cases. The present treatment~     paradigm is conservative with compression garments. There is a need for more effective~     treatment options and regenerative medicine offers hope for a change to a more curative~     approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly~     isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the~     affected axillary region.~   "
35508|NCT02592200|"~     The primary objective is to determine the change in frequency of complete spontaneous bowel~     movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123~     in healthy adult women with functional constipation.~   "
35509|NCT02592187|"~     Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a~     critical window of opportunity to intervene and alter the trajectory of both cognitive and~     functional decline. Emerging life-logging technologies has shown a tremendous potential to~     increase autobiographical memory.~      Objective: The main goal of the present study is to develop a Cognitive Training program~     (CT) for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific~     autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to~     create an application to manage this large collection of images, which can be easily~     retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation.~     The investigators will conduct the first pilot Randomized Controlled Trial (RCT) evaluating~     the effectiveness of the life-logging re-experiencing program immediately and 3-month~     follow-up period.~      Methodology: The Design is a single blind RCT of CT based on life-logging tools. 30 adults~     with MCI, after completion of two weeks image collection by a WeC, will be randomly~     allocated (1:1) into experimental or control group. Once acquire episodic individual's~     videos, all participants will attend 1-hour individual training sessions 2 times per week~     for 14 weeks. Main outcomes measures will be cognitive, functional, emotional and quality of~     life measures, as well as biochemical measures (BDNF).~      Expected results: The investigators expect the outcomes to provide preliminary evidence that~     autobiographical experimentation CT programs can positively impact cognitive functioning and~     may represent an effective strategy to improve memory and functionality in those who begun~     to experience cognitive decline.~   "
35510|NCT02592174|"~     The primary objective is to measure the prevalence of according to the Frascati~     classification in a HIV-infected population aged between 55 and 70 years (exposed group) and~     to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in~     unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on~     age, gender, geographical origin and socioprofessional category.~   "
35511|NCT02592161|"~     A randomized, single center, double blind, parallel, placebo-controlled, clinical study of~     efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the~     improvement of osteoporosis and symptoms in Women's older than 50 patients with~     osteoporosis.~   "
35512|NCT02592148|"~     There is an interest to assess nutritional status of vitamins in humans in a non-invasive~     way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to~     blood for this purpose. The suitability of saliva for status determination will be~     investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva~     and blood.~   "
35513|NCT02592135|"~     The purpose of this study is to better understand myocardial injury in AHF. Secondary~     analyses demonstrate the prognostic significance of troponin release. The absence of such~     release has been associated with less risk. Whether measurement of high sensitivity TnT may~     enable emergency physicians to better risk stratify acute heart failure patients remains to~     be determined. This study will help us to better understand the prognostic value of absent~     or low hsTnT values in the emergency department setting. In addition, we will also test the~     STRATIFY decision rule; a risk score.~   "
35514|NCT02592122|"~     In the patients with COPD mechanical ventilation, the bronchial dilatation is very common.~     However, the evaluation of the efficacy of the medical examination and other subjective~     indicators, such as doctors, depends on the doctor's experience; at present, there is no~     objective evaluation index. For patients with mechanical ventilation, the risk of cross~     infection can not only increase the risk of cross infection, but also increase the workload~     of clinical doctors and nurses. Therefore, this study proposes an objective evaluation~     method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of~     this study can be used to guide the clinical medication through the test of the bronchus. If~     the patients with bronchial dilation test positive were used in the test, the patients were~     not used. In this evaluation method, the changes of airway resistance were measured by the~     accurate measurement of the patients with inhaled bronchial dilatation.~   "
35537|NCT02591823|"~     Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side~     effect profile very different from that seen with high dose methotrexate used in oncology.~     Hair fall has been found to occur in high dose methotrexate but there is no data regarding~     the same when methotrexate is used in low dose.Thus this observational case control study is~     being undertaken to determine whether rheumatoid arthritis patients really need to be~     concerned about hair fall when on low dose methotrexate.~   "
35538|NCT02591810|"~     This prospective randomized control trial (PRCT) aims to compare the outcome of three~     treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without~     concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the~     most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires~     vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.~   "
35515|NCT02592109|"~     The epidemic of pediatric obesity has become a public health burden in both developed and~     developing countries, due to its serious health consequences, including an increased risk of~     type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are~     still the center of preventive and treatment measures of obesity. Recently, the omega-3~     group, one of the groups of polyunsaturated fatty acids (PUFAs), has been associated with~     many positive effects leading to the improvement of many diseases related to obesity.~     Nevertheless, the consumption of this essential nutrient requires certain ration to optimize~     its favorable result. Although previous studies have examined the efficacy of dietary~     counseling approach as treatment for obesity, none of them as explicitly explore the use of~     linear programming to create a tailored diet containing high omega-3 fatty acid food as a~     part of dietary counseling in obesity management program among children. Thus, this study is~     intended to contribute the clinical evidence regarding this area of knowledge, specifically~     the effects of enhanced counseling containing complementary feeding recommendation on~     nutritional status, omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children~     with risk of overweight aged 12 -23 months in East Jakarta.~   "
35516|NCT02592096|"~     To investigate the safety, tolerance, dynamic percolation model of single dose usage~     pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic~     suppurative otitis media~   "
35517|NCT02592083|"~     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6~     inhibitor palbociclib when added to standard endocrine treatment. Initially, patients~     receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67)~     patients are then randomized between either continuous endocrine therapy (arm A) or the same~     treatment with addition of palbociclib (arm B). Patients with no change of proliferation are~     allocated to endocrine treatment + palbociclib without randomization (arm C). During the~     12-weekly treatment period, clinical and radiological evaluations are performed repeatedly.~     Switch between the treatment arms A and B is allowed in case of lack of response or due to~     toxicity. A translational subprotocol is a mandatory part of the study protocol, except for~     use of PET-CT evaluations.~   "
35518|NCT02592070|"~     This study addresses an important public health concern; impoverished cognitive function~     associated with treatment of breast cancer. Due to increased awareness of breast cancer~     combined with advances in medical care, there are over 2.8 million women living with a~     history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove~     cancerous tissue can result in deficits in attention, speed of processing, memory, and~     quality of life. Physical activity has been associated with a number of health benefits for~     breast cancer survivors including improvements in cognitive function. However, most of the~     literature is cross-sectional and it is unclear whether acute (single) bouts of physical~     activity affect cognition and, if they do, how long this effect lasts. This study will be~     the first, to the investigators' knowledge, to examine the effects of an acute bout of~     aerobic exercise on cognitive functioning in breast cancer survivors. Specifically, the~     investigators will determine the effects of a 30-minute moderate intensity aerobic exercise~     session (treadmill walking) on immediate and one hour follow up changes in measures of~     processing speed, memory, and executive function. Additionally, accelerometer cut-points for~     physical activity intensities in breast cancer survivors will be assessed. Finally, the~     investigators will examine the association of cardiorespiratory fitness and physical~     activity with changes in cognitive function. Findings from this study will allow researchers~     to determine whether any acute effects of exercise on cognition are retained over time and~     therefore have real meaning in the context of one's daily life.~   "
35519|NCT02592057|"~     This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens~     administered as per the approved prescribing information in adults with chronic hepatitis C~     virus (HCV) infection treated in routine clinical practice in India.~   "
35520|NCT02592044|"~     The effect of aromatherapy with lavender essential oil on pain and anxiety during~     venipuncture will be evaluated.~   "
35521|NCT02592031|"~     Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17~     and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed~     in human healthy female subjects. Only female subjects will be included in the study to~     reach the objectives of the study.~   "
35522|NCT02592018|"~     This is a single-arm, open-label study, which will examine the effect of secukinumab on the~     immunologic and genetic environment within psoriatic lesions.~   "
35523|NCT02592005|"~     Introduction: An emerging body of evidence indicates that there is an association between~     air pollution exposure in pregnancy and adverse pregnancy outcomes (Rudra, Williams,~     Sheppard , Koenig, & Schiff, 2011; Dadvand, et al., 2013; Ritz, et al., 2014). Adverse~     pregnancy outcomes tend to lead to adverse neonatal outcome and a higher economic cost.~     Epidemiologic studies have also revealed that cardiovascular complications during pregnancy,~     such als preeclampsia, are associated with a greater cardiovascular risk during later life (~     Abramson & Melvin, 2014).~      Aim: This study wants to examine the effects of exposure to environmental factors, polluents~     and particulate matter on the clinical pregnancy outcome for mother and child and to~     determine which biochemical changes in maternal, placental and cord blood best explain this~     effect.~      Methods: This study will be performed in a prospective cohort setup (n=200), recruited from~     the prenatal clinic in the University Hospital Antwerp. The data collection consists of four~     questionnaires (intake, both urine samples and postpartum), two blood samples (28 weeks and~     post-partum), two urine samples (20 and 30 weeks), two hair samples (20 weeks and~     post-partum), cord blood and the placenta.~      Results and conclusion: As the study will start in November 2014, no results are available~     yet.~   "
35524|NCT02591992|"~     To evaluate the safety and effectiveness of computed tomography angiography in the~     diagnostic and therapeutic cycle as the first-choice method of imaging in the diagnosis of~     patients with a high probability of stable coronary artery disease according to European~     Society of Cardiology recommendations.~   "
35525|NCT02591979|"~     The purpose of this study is to develop and validate a work-model in Primary Health Care for~     identifying patients with Sleep Apnea Syndrome, based on clinical variables and an~     ambulatory monitoring study.~   "
35526|NCT02591966|"~     The purpose of this study is to investigate effects of systemic treatments on genomic~     profiles in patients with breast cancer and to compare genomic profiling between~     premenopausal and postmenopausal women by systemic treatments in breast cancer.~   "
35528|NCT02591940|"~     CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual~     physiological human (VPH) projects and checks the applicability and effectiveness of~     available predictive modelling and simulation tools, validating them in interrelated~     clinical trials conducted in three European centres of excellence in cardiac treatment (from~     Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and~     aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a~     result treatment becomes mandatory, but optimum timing and the best type of treatment still~     remain difficult to determine. With more than 50.000 interventions per year within the EU,~     the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present~     clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical~     parameters, without benefiting, as yet, from patient-specific disease modelling based~     prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation~     trials aimed at covering and comparing the complete spectrum of cardiovascular treatment,~     predicting the evolution of the disease and the immediate and mid-term outcome of treatment.~     Operational clustering is going to provide a seamless clinical solution that applies~     different modeling methods to realize the potential of personalised medicine taking into~     account user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to~     provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most~     advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus~     accelerating the deployment of VPH methods in clinical environments, and bring to maturity~     holistic patient-specific computer-based predictive models and simulations.~   "
35529|NCT02591927|"~     The purpose of this study is:~        1. to assess whether pre-hospital glucose-insulin-potassium (GIK) administration in acute~          STEMI patients would reduce infarct size and ischemia/reperfusion damage using~          comprehensive tissue characterization by cardiovascular magnetic resonance (CMR) at an~          early post-infarction phase.~        2. to explore the putative cardioprotective mechanisms of pre-hospital GIK administration~   "
35530|NCT02591914|"~     The objectives of this study are to establish the safety and tolerability of intravitreous~     administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered~     in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with~     subfoveal neovascular age-related macular degeneration.~      Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three~     months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are~     present PER INVESTIGATOR DISCRETION:~        -  ≥ 5 ETDRS letters loss OR;~        -  Significant hemorrhage OR;~        -  New or increased RPE elevation consistent with increased disease activity OR;~        -  Increased neovascular lesion size OR;~        -  New or increased foveal intraretinal fluid~      If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted~     above, Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as~     monotherapy).~      Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24~     administrations.~   "
35531|NCT02591901|"~     Due to the damage caused to the spinal cord, patients with spinal cord injury, cauda equina~     syndrome, multiple sclerosis and transverse myelitis may encounter loss of bladder function,~     which in turn can lead to a debilitating and costly complication: Urinary Tract Infections~     (UTIs). Given that these patients with loss of bladder function do not normally feel~     symptoms like pain - as would be the case in otherwise healthy persons - there is no clear~     agreement among experts on which signs and symptoms are indicative of a UTI. Although strong~     evidence is lacking, antibiotics have been widely used for prevention of recurrent UTIs in~     patients with loss of bladder function. However, this approach is now being questioned as~     antibiotic resistance has become a world-wide health concern. Policy makers recently~     stressed the importance of research into alternative preventative treatments. The use of~     vaccines is one such an alternative approach, which works by stimulating the body's immune~     system. One of these vaccines is a Uro-Vaxom® oral capsule which consists of inactivated~     traces of the bacteria that normally cause at least 83% of UTIs in patients with loss of~     bladder function. Previous studies show that Uro-Vaxom® resulted in a significant reduction~     of UTIs in otherwise healthy patients, as well as being safe to use. Before investigating~     the effects of this promising new vaccine, this proposed study aims to clarify two crucial~     issues. First, after reviewing the literature and appraising patients', carers' and~     healthcare professionals' experiences, the aim is to reach an agreement on how to measure a~     symptomatic UTI in patients with loss of bladder function that results from a spinal cord~     lesion. Second, using Uro-Vaxom® Investigators aim to conduct a smallscale,~     placebo-controlled trial with 48 participants to investigate the feasibility of carrying out~     a larger trial on prevention of symptomatic UTI in such patients.~   "
35532|NCT02591888|"~     Liposomal bupivacaine or placebo will be administered at the end of a transobturator~     midurethral sling to determine if there is a difference in a patient's perceived~     postoperative pain.~   "
35533|NCT02591875|"~     The LEONARDO study is a non-randomized, multicenter, prospective study in which~     consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be~     enrolled. Patients can be treated with any market released catheter for ablation. The~     decision to perform the ablation of AFL will be made based on clinical evaluation of the~     investigators according to their clinical practice. The study does not require specific~     surgical techniques. Patient time commitment for the study is approximately 12 months.The~     study has been designed to describe the italian clinical practice in relation to the~     approach of AFL ablation. In particular, the investigators will describe the methods for the~     validation of ablation success, the techniques adopted, and the patient management~     approaches in the participating centers.~   "
35534|NCT02591862|"~     Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to~     Eculizumab due to complement C5 polymorphisms.~   "
35535|NCT02591849|"~     Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant~     recipients within 10 weeks after transplantation, and has been associated with increased~     risk of cardiovascular disease and impaired patient survival. PTDM is primarily believed to~     be a variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the~     impaired glucose metabolism in renal transplant recipients with PTDM is unclear and some~     aspects are still poorly investigated. Hyperglycemic clamp investigations with concomitant~     infusion of glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of~     the α-cell and β-cell function.~      The primary objective of the present study is to investigate whether hyperglucagonemia is~     present in renal transplant recipients with PTDM. Furthermore, the investigators aim to~     examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo)~     in PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic~     clamp), respectively.~   "
35536|NCT02591836|"~     The primary purpose of this placebo-controlled study is to evaluate the low‐density~     lipoprotein cholesterol (LDL‐C) efficacy and dose‐response of gemcabene 300, 600 and 900~     mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day~     to hypercholesterolemic patients.~      Secondary purposes include evaluating the effects of high‐sensitivity C-reactive protein~     (hsCRP), high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG) and apolipoprotein~     B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin~     combination.~   "
35539|NCT02591797|"~     This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio~     will be to evaluate the effectiveness of Hands/Eyes/mouth behavior management technique~     versus a conventional technique (covering the patient´s vision) during an inferior alveolar~     and lingual nerve block in preschool children referred for treatment at the School of~     Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52~     children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or~     tooth extraction of primary molars. Preschool children with no history of allergies to~     Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the~     study will be include in this research.~   "
35540|NCT02591784|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope~     located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).~     Clinical efficacy has been shown in adult with head and neck cancer. The phase II study~     assessed the efficacy and safety of the combination of Nimotuzumab administered~     concomitantly with radiotherapy in patients with esophageal cancer tumours.~   "
35541|NCT02591771|"~     The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as~     an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion~     monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock,~     including ventricular mechanical support.~   "
35542|NCT02591758|"~     The first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global~     level, patients with chronic angina are at risk of poor vital status and deconditioning.~     Medical therapy and coronary revascularization using coronary artery bypass graft (CABG) or~     percutaneous coronary intervention (PCI) can effectively relieve angina . In spite of all~     the available treatment options, the assessment of angina remains a challenge. Angina has a~     cyclical pattern and will naturally worsen and improve as days go by. Likewise, angina can~     be significantly biased by the placebo effect. Clinically angina is most frequently~     quantified with the Canadian Cardiovascular Society (CCS) classes system. In research~     protocols, angina is often quantified with health-related quality of life questionnaires and~     diaries. None of the tool available accounts for an important phenomenon called ischemic~     threshold adaptation, which could be defined as a limitation of their activity level under~     the ischemic level, which will translate into fewer angina episodes and a seemingly stable~     condition. Better clinical assessment tools that take into consideration the ischemic~     threshold adaption are needed.~      Despite increased interest in wearable biometrics clothing in medicine, no prospective study~     has documented their utility to assess angina and to monitor the rehabilitation in cardiac~     patients. The Hexoskin™ is a biometric vest that can collect physiological data from~     individuals in their natural daily living environment. Currently, the use of biometric~     clothing is confined to a niche exploited exclusively by health enthusiasts, athletes or~     astronauts. As we enter this new age of virtual healthcare, tools like wearable biometrics~     could represent a giant leap forward in assisting healthcare professionals and patients.~     This will translate a better assessment of their health status, will allow physicians to~     target the right treatment strategy, ultimately improving case-selection and outcomes.~      Our objective is to prospectively validate the wearable biometrics clothing Hexoskin™~     against established standards used to assess chronic stable angina. In addition, the~     investigators want to derive a novel vitality index from the data generated by this device~     that will subsequently be used to propose a new angina classification system that will~     account for ischemic threshold adaptation. Moreover, the investigators want to evaluate the~     safety and efficacy of Hexoskin monitor patients undergoing home-based cardiac~     rehabilitation.~   "
35543|NCT02591745|"~     This registry aims to gather anesthetic medications administered to fetuses directly as well~     as those administered via the mother during fetal intervention procedures. The goal is to~     assesss short and medium term outcomes as well as long term outcomes of these babies whao~     have received medication in utero. The long term outcomes will include but are not limited~     to neurodevelopmental outcomes.~   "
35544|NCT02591732|"~     The purpose of this study is to describe the characteristics of patients treated with~     different OATs and whether these characteristics differ between treatments.~      Furthermore to describe persistence to each OAT and risk of bleeding after initiating each~     OAT.~   "
35545|NCT02591719|"~     The aim of this study is to assess the safety and clinical efficacy of repetitive~     transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with~     functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia~     patients.~   "
35546|NCT02591706|"~     Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be~     compared. Implant success rate will be evaluated by measuring the peri-implant bone~     remodeling from baseline to 1 year post insertion.~      The hypothesis is those implant survival rates of the test (V3) and control group (C1) are~     similar and that test V3 implant allows less peri-implant bone loss.~      Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1~     implants will be compared. The bone thickness will be measured in cone beam computerized~     tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.~      The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.~   "
35547|NCT02591693|"~     The purpose of this study is to determine whether a training intervention to improve~     caregiver confidence for family caregivers of patients with palliative care needs at home,~     is acceptable to patients and their caregivers.~   "
35548|NCT02591680|"~     Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during~     ascent and descent stairs after the addition of neuromuscular training to hip muscle~     strengthening.~   "
35549|NCT02591667|"~     There is a paucity of data on the histopathological response of peritoneal tumor deposits~     from colorectal cancer to neoadjuvant chemotherapy. Particularly, no prospective assessment~     of chemotherapy-associated histopathological response within the peritoneum has been~     performed so far. Therefore, there is an urgent need to conduct a clinical trial aimed at~     prospectively assessing the histopathological response within the peritoneum in patients~     with peritoneal metastasis from colorectal cancer.~      Recently, Loupakis et al. reported that the triplet regimen of 5-fluorouracil, oxaliplatin~     and irinotecan (FOLFOXIRI) in combination with bevacizumab significantly improved median~     progression-free survival in metastatic colorectal cancer patients from 9.7 to 12.1 months~     as compared with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab. In view~     of these data, it is likely that FOLFOXIRI + bevacizumab will also lead to a significant~     improvement of the histopathological response within the peritoneum of patients with~     peritoneal metastasis from colorectal cancer (pcCRC) as compared with previous standard~     chemotherapy.~      The investigators hypothesize that FOLFOXIRI + bevacizumab will induce a pCR or major~     response in peritoneal tumor deposits in >30% of patients (taking the response rate to~     FOLFOX- or FOLFIRI-based neoadjuvant chemotherapy from the published literature as a~     reference).~   "
39979|NCT02533687|"~     With this study, it is aimed to compare the operative results and complication rates in~     transurethral resection of the prostate (TUR-P) performed by resectoscopes with two~     different bipolar and a monopolar energy sources.~   "
35550|NCT02591654|"~     The purpose of this study is to test two imaging techniques, one called whole body (WB)~     diffusion weighted (DWI) magnetic resonance imaging (MRI) (WB-DWI MRI), and another called~     Fluorine-18 3'-deoxy-3'-fluorothymidine positron emission tomography (PET) (F-18-FLT PET).~     The goal is to see whether these imaging techniques would allow the study doctors to see~     changes in the size of a tumor earlier for patients with metastatic melanoma receiving~     Pembrolizumab (MK-3475).~   "
35551|NCT02591641|"~     Does the use of an anti-shear mattress overlay placed on a pre-hospital transport stretcher~     reduce shear forces and pressure on the skin, and increase patient comfort as compared to~     standard care.~   "
35552|NCT02591628|"~     This proposed pilot study will test methods and feasibility for a large pragmatic clinical~     trial comparing two inexpensive, first-line drugs for treating high blood pressure to~     determine if one is superior in preventing serious cardiovascular events and death. It will~     develop and test novel approaches to conducting trials that will be faster, less expensive,~     and more realistic by being embedded in a typical practice setting and using advanced health~     information technology.~   "
35553|NCT02591615|"~     This is a multicenter randomized phase II to determine if the administration of standard~     platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small~     Cell Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475~     administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to~     1 year: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by~     pembrolizumab every 3 weeks for up to 1 year. Pembrolizumab every 3 weeks x 4 cycles~     followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by~     pembrolizumab every 3 weeks for up to 1 year.~   "
35554|NCT02591602|"~     Transporting radiology to the patient's home is challenging. Preliminary experiences~     conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple,~     light-weight X-ray equipments with a Computed radiography or Digital Radiography systems~     could be effective for externalization of radiographic service.~      The image and examination quality has been proved to be the same than those performed with a~     stationary equipment and analysis on safety of radio-protection systems show a very low risk~     exposure for health staff as well as for the general population.~      Mobile radiography in nursing homes has shown to be technically feasible and the most~     beneficial results were that patients avoided unnecessary transport back and forth to the~     hospital; in both experiences the majority of patients could be treated locally.~      The key points of RADHOME project are two:~        1. The first one is to built a network model, with the aim to disseminate clinical use of~          domiciliary radiology.~        2. The second one is to demonstrate clinical efficiency and cost-effectiveness of~          domiciliary radiology.~   "
35555|NCT02591589|"~     This is a randomized, prospective controlled trial in patients undergoing cardiac surgery,~     specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen~     and partial pressure of arterial oxygen in the operating room and its impact on a~     widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment~     (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It~     is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout~     the intraoperative period will have better neurocognitive function than those with~     maintenance of hyperoxia.~   "
35556|NCT02591576|"~     Diabetes is key risk factor for death following acute myocardial infarction. However, the~     long-term excess risk of death associated with diabetes following acute myocardial~     infarction not known. Investigators aimed to determine the long-term excess risk of death~     associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and~     non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.~   "
35557|NCT02591563|"~     The purpose of this study is to assess the effectiveness of Prevnar 13 against pneumococcal~     acute otitis media.~   "
35558|NCT02591550|"~     The aim of this study is described as follows,~        1. To establish a validated method to test cough reflex sensitivity conducted by transient~          receptor potential vanilloid 1(TRPV1).~        2. To observe the variance of cough reflex sensitivity conducted by transient receptor~          potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough~          reflex sensitivity conducted by TRPA1 and conducted by TRPV1.~        3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough~          reflex sensitivity.~   "
35559|NCT02591537|"~     Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the~     lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment~     arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound~     healing will be observed over 14 days.~   "
35560|NCT02591524|"~     A hot topic in lung transplantation is the treatment of persisting sinus~     disease/colonization in CF patients to prevent descending graft colonization and chronic~     allograft dysfunction. From 2012, the Hannover transplantation group has been using a~     conservative approach with topical nasal inhalation. It is now necessary to analyse the~     impact of the new approach on graft colonization, incidence of BOS, symptoms, QoL etc in~     comparison to a historical cohort. It is also important to establish which is the best among~     the different inhaled antibiotic regimens currently available.~   "
35561|NCT02591511|"~     The aim of this study is to establish PAtient-Centered Computerized Educating System for~     Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the~     intervention group will receive the PACCESS and the control groups will receive traditional~     health education to test the effects of PACCESS in increasing clinical decision-making,~     health behavior, activities of daily living and knowledge of stroke, and health care~     quality.~   "
35562|NCT02591498|"~     The purpose of this study is to investigate the effect of a neuroplasticity-based~     computerized cognitive training for people with schizophrenia in the Brazilian population.~   "
35573|NCT02591355|"~     Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad~     applications for a number of medical indications including those in orthopedics, dentistry,~     and dermatology. In dermatology, its uses have included treatment of chronic wounds and~     facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the~     treatment of hair loss, but to the best of our knowledge, there has been only one published~     case series documenting its use for this indication.~   "
35563|NCT02591485|"~     The purpose of this study is to explore the efficacy of Attention Control Training in~     preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near~     after a traumatic event and before PTSD is develop.~      Individuals who underwent a traumatic event in the past two weeks will be randomly assigned~     to either Attention Control Training (ACT), designed to normalize threat-related attention~     biases or a control conditions: a psych-education intervention, designed as an active~     placebo condition or a follow-up condition, without intervention at all.~      Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived~     from the Clinician Administered PTSD Scale (CAPS-5), after 3 and 6 month since the traumatic~     event had occurred.~      The investigators expected to find lower ratios of PTSD symptoms in the ACT condition~     relative to the control conditions in which no symptomatic relief is expected.~   "
35564|NCT02591472|"~     Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain~     traumatic orthopedic injuries such as major fractures or amputation each year. Injury is~     treated in the hospital by physicians who medically stabilize and reconstruct the patient.~     Upon completion of their hospital stay, patients are discharged to begin their reintegration~     back into home and community activities. Despite high surgical success and survivorship~     rates, these injuries often result in poor quality of life (QOL)-related outcomes in~     otherwise healthy people. Fifty to ninety percent of patients develop severe psychological~     distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often~     not provided the comprehensive support care and resources that are necessary to cope~     successfully with psychological stress and reintegrate into purposeful living. This is a~     major problem because high distress levels predict poor physical function, use of pain~     medications and low QOL. Survivors often cannot return to work, have persistent pain and~     experience social isolation. Distress worsens the self-perceptions of functional gain and~     efficacy and decreases personal fulfillment. Lingering psychological distress contributes to~     the development of other health problems and rebuilding of life is negatively impacted. The~     lack of psychosocial support contributes to injury re-occurrence, injury recidivism,~     re-hospitalizations and longer hospitalization stays, and higher personal and societal~     health care costs.~      There is currently a lack of comparative efficacy research to determine which delivery~     approach produces greater improvements in the outcomes that are most desired by patients,~     specifically, functional QOL and emotional well-being. The proposed research will directly~     compare these delivery-of-care approaches and measure the patient-reported outcomes that are~     considered important to patients.~   "
35565|NCT02591459|"~     The objective of this work is to develop an application to run on a mobile device Android~     tablet that features visual routines for autistic children.~   "
35566|NCT02591446|"~     Autism Spectrum Disorder (ASD) is the most prevalent of the developmental disorders and~     their incidence is rising. However, the variability in the behavioral symptoms is large. In~     part for these reasons, the ASD clinical diagnosis is challenging and often is not made~     until 3-5 years of age. Thus, there remains an unmet need for a valid and reliable marker~     which would facilitate ASD diagnosis early in life, enable efficient study of ASD risk~     factors, and eventually serve as a useful marker to inform the development of effective~     therapies and assess treatment response in future clinical trials. The specific brain based~     marker that investigators are currently evaluating is brain plasticity (the changes that~     occur in your brain through experience). Investigators measure brain plasticity using~     noninvasive brain stimulation including transcranial magnetic stimulation (TMS) combined~     with brain imaging, EEG, and behavioral outcome measures. Their work to date demonstrates~     the potential utility of these techniques in higher-functioning adolescents and adults with~     ASD, and pilot data support the feasibility and safety of applying the same measures to~     children and lower functioning individuals.~      In this study, investigators will evaluate the validity of this marker in low- and~     high-functioning adults with ASD, in low- and high-functioning children with ASD, and assess~     the reliability of this marker.~   "
35567|NCT02591433|"~     This pilot clinical trial studies how well the JeffQuit group therapy program works in~     enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group~     therapy to provide psychological support and address the mental need for smoking, the habit~     or routine it creates, and the physical need for nicotine. It is not yet known how well the~     JeffQuit program will work in helping patients with a history of cancer to stop smoking.~   "
35568|NCT02591420|"~     This study will evaluate the safety and virologic effect of an experimental human monoclonal~     antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral~     therapy (ART), in adults during early acute HIV infection.~   "
35569|NCT02591407|"~     The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients~     undergoing elective colorectal surgery that have been randomized to transversus abdominis~     plane block or epidural anesthesia for the management of perioperative pain in elective~     colorectal surgery.~   "
35570|NCT02591394|"~     The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic~     designed for stroke patients and was established to provide a comprehensive approach to~     stroke risk factor reduction. The goal of this study will be more effective than usual care~     at reducing blood pressure in patients with poorly controlled blood pressure after an~     ischemic or hemorrhagic stroke or transient ischemic attack.~   "
35571|NCT02591381|"~     The investigators propose a randomized non-blinded comparison of standard vs. transcorporal~     approach for placement of an artificial urinary sphincter in male patients with stress~     urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the~     United States, the artificial urinary sphincter (AUS), manufactured by American Medical~     Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in~     men. The cuff, which is the portion of the device that encircles and occludes the urethra,~     is typically placed directly around the urethra (i.e., standard placement). The cuff can~     erode into the urethra. Transcorporal placement has been introduced as a method to reduce~     the risk of erosion. Transcorporal placement involves tunneling the cuff through the~     erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never~     been compared to standard placement in a randomized fashion. In the randomized trial, no~     additional procedures beyond the normal care protocol will be required of the patients. The~     investigators will conduct the study through an established, IRB-approved~     multi-institutional network of surgeons. Success will be assessed via objective and~     subjective methods; complications will be tallied in a standardized fashion. Outcomes will~     be measured at two years.~   "
35572|NCT02591368|"~     This prospective randomized trial aims to ascertain differences in outcome measures for the~     operative treatment of basilar thumb arthritis by comparing the two most common surgical~     treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both~     subjective and objective data to determine if a particular surgical method offers more~     favorable outcomes.~   "
35574|NCT02591342|"~     Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with~     considerable morbidity and mortality. Recent cohort studies have demonstrated a high~     incidence of PPF in elderly patients treated with two commonly used polished, tapered,~     collarless stems in elderly patients. The aim of this study was to compare the rate and~     characteristics of PPF in a consecutive cohort of patients treated either the polished~     tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of~     age with femoral neck fracture.~   "
35575|NCT02591329|"~     The objective of this research is to test the effectiveness of persuasive messages targeted~     at parents who have children who consume inadequate amounts of calcium. Specifically, the~     effectiveness of the intervention material on increase a) the purchase of calcium-rich~     products by parents, and b) the consumption of calcium-rich products in the parent and child~     will be examined in 400 families across Canada. Families will receive either the targeted~     intervention materials or standard of care generic nutrition materials retrieved from Health~     Canada's website. Materials will be delivered to parents during weeks 0, 8, 16, and 22 of~     the study. Monitoring of parents' calcium product purchases and consumption behaviour in~     both parents and children will occur at week 0,12, 24 weeks (immediately post-intervention)~     and at 52 weeks (i.e., 6-month follow-up). Purchases will be verified by grocery receipts~     made during the aforementioned weeks. Parents will self-report on their dietary consumption~     as well as their child's using a food frequency questionnaire. The study hypotheses are as~     follows:~        1. Parents in the experimental condition will purchase more calcium-rich products as~          compared to parents in the control condition.~        2. Parents and children in the experimental condition will consume more calcium rich~          products as compared to parents and children in the control condition.~        3. Perceived outcome expectancies of consuming calcium-rich products will increase to a~          greater extent in parents in the experimental condition as compared to parents in the~          control condition.~        4. Self-regulatory efficacy to consume calcium-rich products will increase to a greater~          extent in parents in the experimental condition as compared to parents in the control~          condition.~        5. Perceived social support and role modelling behaviour will be highest in parents in the~          experimental condition as compared to parents in the control condition.~        6. Self-regulatory efficacy and outcome expectancies will mediate the changes in~          calcium-rich product purchases and consumption.~   "
35576|NCT02591316|"~     The purpose of this study is to examine the relationship between nutrition, physical~     activity and brain function in breast cancer survivors.~   "
35577|NCT02591303|"~     Insomnia is characterized by rumination and worry over stressful events affecting nighttime~     sleep. Emotional reactions while stressful events are ongoing have not often been~     investigated in insomnia. In the current study stress reactions will be measured during a~     real-life simulation experiment with stressful events and investigate not only how previous~     sleep patterns affect emotional reactivity to the event but also how the emotional events~     affect sleep patterns the following night.~      Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with~     insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects~     of either neutral or stressful events during driving. Through questionaires and intake~     polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep~     medication use and alternative sleep disorders than insomnia. Stress levels will be measured~     through skin conductance and heart rate variability during events and through nighttime~     polysomnography (PSG). Effects on sleep architecture and arousal levels will be measured~     through nighttime PSG.~      Investigators hypothesize that subjects with insomnia, compared to subjects without sleep~     complaints, show stronger emotional reactions to stressful events and stronger effects of~     stress on sleep quality the following night. Results will facilitate a model for emotional~     reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption~     converting into chronic insomnia and aid in developing customized insomnia treatment.~   "
35578|NCT02591290|"~     The aim of this study is to collect further information regarding an increase immune~     response of SP284 after an additional dose in Japanese subjects.~      Primary Objective:~        -  To evaluate and describe the immune responses to meningococcal antigens (serogroups~          A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in subjects~          20 through 55 years of age.~      Other Pre-specified objective:~        -  To describe the safety in terms of immediate systemic adverse events, solicited~          reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs)~          following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.~   "
35579|NCT02591277|"~     This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir~     (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult~     patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni~     in routine clinical use, the primary objective of this study is to evaluate the incidence of~     adverse drug reactions (ADRs) under real world settings.~   "
35580|NCT02591264|"~     The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the~     occurrence of periprocedural myocardial infarction.~   "
35581|NCT02591251|"~     Laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. It~     allows surgeons to take a look on the abdominal and pelvic organs. Diagnostic laparoscopy is~     usually done in an operating room under general anesthesia. The procedure takes about 25~     minutes and the patients usually discharged in the same day. The laparoscopy can diagnose~     pelvic pathological conditions in approximately 50% of the cases. However, the laparoscopy~     has some complications, such as infections, hemorrhage and injuries of visceral organs.~      A preoperative vaginal preparation is important to prevent the bacteria colonization in a~     trial to avoid postoperative infection after laparoscopic surgery. The povidone-iodine (PI)~     is normally used as a skin and vaginal disinfectant to prevent postoperative infections,~     however; it can be the cause of significant postoperative irritation.~      There are many reports in the literature proved that the mechanical cleansing of the vagina,~     not the use of an antiseptic solution, is responsible for the efficacy of vaginal~     preparations. In the field of assisted reproductive technology; A study in 1992 concluded~     that the infection rates with normal saline solution are comparable to PI.~      Another proved that, a normal saline solution can be effective in prevention of preventing~     postoperative infections after vaginal surgery.~      The most recent study by Lewis et al has been shown that the Baby shampoo is preferable than~     PI in vaginal cleansing before gynecologic procedures because it has minimal vaginal~     irritation and cheaper than PI.~      So the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a~     randomized trial comparing 2 commonly used vaginal antiseptic solutions: PI and the saline~     solution before the laparoscopic surgery.~      The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning~     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike~     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.~   "
35582|NCT02591238|"~     The main purpose of this study was to evaluate the effects of melatonin in the regulation of~     the vascular injury in smokers through population-based, randomized, double-blind,~     placebo-controlled trial.~   "
35591|NCT02591121|"~     Prospective, single-centre study in healthy volunteers to establish a reference range for~     the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the~     reference range for measurement of PCT levels using the RAMP Procalcitonin test.~   "
35637|NCT02590523|"~     The goal of this study is to determine the safety (but not efficacy in preventing infection)~     of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin~     at certain dosages and concentrations as prepared by a compounding pharmacy when used~     intracamerally at the time of cataract surgery.~   "
35638|NCT02590510|"~     The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in~     the treatment of meningeal carcinomatosis.~   "
35583|NCT02591225|"~     This is a single-center, randomized, two treatment groups, open, phase IV clinical study in~     subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit)~     subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are~     eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria~     and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can~     be performed followed by randomization to one of the two treatment groups (Phenprocoumon or~     Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with~     Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical~     follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up~     TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at~     this visit. If the subject was randomized in the VKA group routinely INR measurements will~     performed.~   "
35584|NCT02591212|"~     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of~     bystander training elements (delivery mode and integration of substance abuse prevention)~     among cohorts of incoming undergraduates at the University of Kentucky, a nationally~     recognized leader in addressing sexual violence through bystander intervention programming.~     Per university policy, all incoming undergraduates will participate in mandatory online~     training covering sexual violence awareness, bystander concepts, and alcohol use/abuse.~     Consenting students will be randomized to one of the following training conditions:~        1. Green Dot Intensive Bystander Training (INT) or~        2. Student Wellness Training (active control). Students in each condition will be followed~          for 9 months, one academic year.~   "
35585|NCT02591199|"~     The purpose of this study is to determine if the combination product (URG101) is safe and~     effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for~     the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and~     double-blinded such that neither the subject nor doctor will know which drug or placebo is~     received.~   "
35586|NCT02591186|"~     Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the~     Center for Fertility & Reproductive Surgery will be eligible for the study. Seventy women~     will be recruited and randomly assigned to either the intervention (acupuncture plus~     standard care) or the comparison (standard care alone) group. (2) Intervention: Participants~     in the intervention group will receive 3 acupuncture sessions during the project with the~     first treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo~     transfer and the third one day post transfer. Participants in the comparison group will~     receive no intervention but will receive standard care. (3) Measures: The primary outcome~     measures include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome~     measures include perceived stress levels. (4) Procedure: Upon IRB approval, an informed~     consent will be provided to all participants. Pre- and post- acupuncture urinary metabolites~     of prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will~     be administered before and after each acupuncture session for the study group, and before~     and after a 30-40-minute waiting period for the control group.~   "
35587|NCT02591173|"~     Pharmacologic approaches to increase levels or actions of the vasodilatory peptide~     angiotensin-(1-7) are currently in development for the treatment of hypertension based on~     findings from animal models. There are limited and contradictory clinical studies, however,~     and it is not clear if this peptide regulates blood pressure in humans. The purpose of this~     study is to better understand the cardiovascular effects angiotensin-(1-7) in human~     hypertension, and to examine interactions of this peptide with the autonomic nervous system.~     The investigators propose that the difficulties in showing angiotensin-(1-7) cardiovascular~     effects in previous clinical studies relates to the buffering capacity of the baroreceptor~     reflex to prevent changes in blood pressure. Autonomic failure provides the ideal patient~     population to test this hypothesis. These patients have loss of baroreflex buffering and~     have low levels of angiotensin-(1-7) in blood. The investigators will test if~     angiotensin-(1-7) infusion can lower blood pressure in patients with autonomic failure, and~     will determine the hemodynamic and hormonal mechanisms involved in this effect.~   "
35588|NCT02591160|"~     Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the~     ambulatory setting. PHPT may be cured with surgery and indications for intervention have~     been defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ),~     the most commonly prescribed medication for hypertension, reduces urinary calcium excretion~     and confounds urinary testing. As a result, it is universally recommended that thiazide~     diuretics be stopped in advance of urinary testing. To date, no studies are available to~     provide evidence-based guidance as to how long HCTZ must be held for urinary calcium~     excretion to return to steady state in PHPT. The objective of this study is to serially~     calculate urinary calcium/creatinine clearance ration in patients with suspected PHPT while~     holding HCTZ to determine the minimum duration of medication cessation necessary for urinary~     calcium clearance to reach steady state.~   "
35589|NCT02591147|"~     This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel~     arms: an intervention group using silver diamine fluoride (SDF) and a placebo group~     (control). 144 eligible healthy adults will be enrolled in the study and randomly assigned~     to one of the two treatment groups. Both groups will receive the traditional preventive~     measures including cleanings, Fluoride varnish, diet analysis and counseling. Study~     participants will be followed for two years and caries progression will be radiographically~     monitored.~   "
35590|NCT02591134|"~     The effects of non-nutritive sweetened (NNS) beverages on weight management and~     psychological indices of appetitive behaviour have not been assessed in both weight loss and~     maintained weight loss phases over the long term to determine whether NNS beverages may~     assist in efforts to lose weight and maintain weight loss and how this affects appetite~     expression (satiety, food choice, craving, ease of dieting etc.). Thus the present research~     will determine the impact of NNS beverages as compared to water on weight loss and weight~     loss maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state~     across both a period of weight-loss as well as a weight-maintenance phase. To determine if~     the effects of NNS on appetite are beneficial or detrimental to successful weight~     management, the study will also systematically compare the effects of NNS beverages, water~     and caloric beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy~     intake (including food choice and caloric compensation) across the whole day during active~     weight management in a subset of participants.~   "
35592|NCT02591108|"~     The assessment of neuromuscular blockage is common practice in the operating room, in which~     such agents are employed. Still today, the use of simple hand held stimulators and visual~     monitoring of these responses are the norm. The investigators want to study the potential~     for employing a non‐invasive quantitative device with built in sensors that will hopefully~     accurately determine the degree of neuromuscular blockade. This system utilizes commonly~     employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and~     an automated detection system. This system will not only utilized pre‐blockade, but also~     throughout an entire surgical procedure and during reversal therapy. For comparisons, the~     investigators will use both the prototype device and a standard hand held TOF for the~     assessment of neuromuscular blockage. In other words, the planned protocol will involve~     testing the effectiveness and accuracy of the device concurrently with peripheral nerve~     stimulation, during a procedure as is done for the current standard of care. All protocols~     will be carried out under the direct guidance and supervision of anesthesiologists and/or~     nurse anesthetists.~   "
35593|NCT02591095|"~     ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian~     cancer.~   "
35594|NCT02591082|"~     This is an observational study to assess patient survival and clinical outcomes after the~     RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.~   "
35595|NCT02591069|"~     Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which~     often occur following traumatic brain injury or ischemia. These alterations result most of~     the time in patients' loss of autonomy and require long years of special care. No efficient~     therapy to improve patients' consciousness has been found so far. Investigators propose to~     use vagal nerve stimulation (VNS) to restore cortical activity and patients' embodied self.~     The investigators' main hypothesis is that VNS will reestablish the thalamo-cortical~     connectivity leading to an improvement of the consciousness state. To test this hypothesis,~     investigators will use behavioral measures as well as fMRI, PET scan and EEG to assess brain~     activity. Patients will be evaluated before and during eight months following implantation~     of the stimulation device.~   "
35596|NCT02591056|"~     The purpose of this study is to determine whether low level laser light therapy applied~     using the Erchonia Verju Laser combined with manual lymph drainage applied using the Iskra~     Medical Green PRESS 8 Lymph Drainage System is effective in reducing the circumference of~     the waist, hips and upper abdomen.~   "
35597|NCT02591043|"~     Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical~     stabilisation of the posterior pelvic ring on 55 patients. These patients have not received~     a structured follow up examination or evaluation of outcome after surgery.~   "
35598|NCT02591030|"~     Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their~     therapeutic management is complex and must be multidisciplinary in nature. Most of the time,~     an endoscopic or radiological biliary drainage is necessary before any tumour treatment.~      Their prognosis is poor due to the fact that they are normally diagnosed late, which makes~     curative surgery impossible. A population study in the Côte d'Or region of France reported a~     survival rate at 5 years of approximately 10%.~      For the locally advanced or metastatic forms, treatment has not been properly codified. With~     respect to chemotherapy, prospective studies, most often phase II, are difficult to~     interpret due to a limited number of patients and due to the heterogeneity of this type of~     tumour (bile duct and pancreas tumours). Treatment with 5FU alone provides an objective~     response in approximately 10% of cases. In combination with mitomycin or carboplatin, the~     objective response rate is 20%, with a median survival period of 5 months. Interferon~     combined with 5FU has a better response rate (30%), but occurrences of different types of~     toxicity are more frequent.~      More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour~     control in 50% of patients with a median survival period of 10 months. Gemcitabine combined~     with oxiplatin or with cisplatin has shown the same response rate but a median survival~     period of approximately 12 months.~      The benefit of this combination has been confirmed in a phase III trial that compared the~     gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally~     advanced unresectable and/or metastatic bile duct cancer. The results were in favour of the~     combined treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64~     [0.52 - 0.80]). This combination is currently the reference first-line treatment.~   "
35599|NCT02591017|"~     34 adult (>18 years) cancer pain outpatients with Opioid base therapy because of pain and~     breakthrough pain or extreme pain on movement will be included in this prospective,~     randomized, double-blind crossover study.~      Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one~     week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan~     spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan~     spray nasal.~      Primary endpoint is time to onset of action of intranasal ketamine compared with morphine~     drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using~     the spray or morphine or the combination of ketamine spray and morphine drops.~   "
35600|NCT02591004|"~     The aim of this study is to investigate the possible use of calcium channel as a~     neuroprotectant in cases with PTL. This will be done by comparing the effect they have on~     cerebral blood vessels with the already established MgSo4. They have been proven superior to~     magnesium sulphate in tocolysis, and they possess the mechanism of action that would allow~     for their theoretical use as neuroprotective agents.~   "
35601|NCT02590991|"~     This study investigate the long term effect of supplementation of pre- and probiotics in~     early life in children born by Caesarean Section.~   "
35602|NCT02590978|"~     Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in~     patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that~     there is a shorter hospital stay and no higher complication rates.~   "
35603|NCT02590965|"~     This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial~     to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients~     with advanced non-squamous non-small cell lung cancer who failed to second-line standard~     chemotherapy.~   "
35604|NCT02590952|"~     Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated~     strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR~     mutations in pre-clinical setting. This first-in-human study is conducted to assess the~     maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability,~     pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.~   "
35605|NCT02590939|"~     The main objective of this study is to assess the efficacy of the Cefaly® device as an acute~     treatment of migraine attack in adult patients. The patients will be applied either an~     active or placebo external neurostimulation for 1 hour during a migraine attack, and will~     report the pain on a visual analog scale before and after the treatment.~   "
35606|NCT02590926|"~     Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe~     and efficacious way of ischemia testing for patients with stable angina. The new recently~     ESC guidelines have strongly suggested a FFR based approach for patients with stable angina,~     also for those with challenging lesions like left main disease, severe multivessel stenosis~     for heart failure patients and those with single remaining vessels although left main~     disease and an ejection fraction less than 30% are exclusion criteria of the randomized~     controlled trials on this topic. Consequently the investigators performed a prospective~     multicenter study to understand the safety and efficacy of a FFR based approach for these~     patients.~   "
35607|NCT02590913|"~     The purpose of this study is to investigate the metabolic and endocrine responses during 3~     hour after taking 75g fructose or glucose in young Chinese.~   "
35608|NCT02590900|"~     Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was~     significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due~     to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a~     proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal~     clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in~     glucuronidation clearance may in part be driven by oestradiol, and may explain within and~     between individual differences in paracetamol metabolism (e.g. oral contraceptives,~     follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.~      Based on a pooled analysis, investigators aimed to further explore the impact of these~     covariates on paracetamol metabolism based on plasma and urine collections in women at~     delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral~     contraceptives (OC) following intravenous (iv) paracetamol administration.~   "
35609|NCT02590887|"~     The purpose of this study is to determine the health effects of the 4 weeks intake of a~     drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood~     markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver~     metabolism, together with general hematology and blood coagulation will be assessed at~     baseline time (day 0) and after (day +14, +28 and +42) drink ingestion.~   "
35610|NCT02590874|"~     The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to~     improve cognition in individuals with Mild Cognitive Impairment.~   "
35611|NCT02590861|"~     Distal extension Partial Removable Dental Prostheses (PRDPs) are less stable than tooth~     supported PRDPs due to progressive resorption of the alveolar ridge, which alters the~     retention and support generated by alveolar bone height. In addition, long-term wearers~     suffer with progressive alveolar ridge resorption that contributes to greater instability.~     The loss of stability and retention under the PRDP can lead to difficulties during~     mastication and swallowing, because of movement of the partial denture. These difficulties~     force patients to self-select food substances that are softer and easier to chew and~     possibly create changes in social eating. Therefore, having a partial denture that is poorly~     retentive will impact their oral health related quality of life Oral Health Related Quality~     of Life (OHRQoL). The placement of a dental implant into the edentulous area will transform~     a conventional PRDP into an Implant Supported PRDP, which will improve the functional~     capacity of partial denture wearers, especially their ability to comminute harder food~     substances such as fruits and nuts. The purpose of this study is to quantitatively measure~     the functional differences of patients wearing conventional PRDP with patients wearing~     implant supported PRDPs and Oral Health Impact of patients wearing implant supported PRDPs.~     The hypothesis is that patient wearing implant supported PRDPs will have greater functional~     capacity than patients wearing conventional PRDPs.~   "
35612|NCT02590848|"~     Background: Adolescence is an important period for brain development as a result of~     increased synaptic plasticity. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are essential~     nutrients for brain development and protection against oxidative stress. Walnuts have the~     highest n-3 PUFA concentrations of all edible plants.~      Objective: The investigators hypothesize that walnut intake will increase n-3 PUFA~     availability in the body to a level that enhances the development of the brain during~     adolescence. The technicians will conduct a long-term (6 months) population-based randomized~     controlled trial in teenagers (n=400), and determine the effectiveness of the intervention~     (30 g of walnut kernels per day, ~1.5g of n-3 PUFA) in enhancing brain development.~      Methods: Fieldwork team will contact teenagers and families in collaboration with 20 high~     schools. Families will receive a basic guide on following a healthy diet in order to ensure~     implementation and adherence. Brain development outcomes will be measured at baseline and~     after the intervention. The use of computerized neuropsychological tests will provide the~     precision required to detect even subtle changes in brain development resulting from the~     nutritional intervention. Behavioral (socio-emotional) development will be assessed in order~     to cover a wider picture of brain development. Blood samples will be collected to measure~     n-3 PUFA levels before and after the intervention in a randomized subsample from both groups~     (control/ intervention). Linear regression models adjusted for baseline neuropsychological~     scores will be used to analyze the intervention effect.~      Implications: The outcomes of this Project are expected to be a greater understanding of the~     role of n-3 PUFA intake (walnut) in brain development. A major goal in public health~     research is to develop cost-effective health recommendations to teenagers.~   "
35613|NCT02590835|"~     This study was designed as a randomized controlled clinical trial to compare conventional~     orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS~     group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege~     University Hospital, Belgium who met the inclusion criteria were enrolled from January to~     October of 2013.~   "
35614|NCT02590822|"~     There is an epidemic of type 2 diabetes in younger adults. These patients are at very high~     lifetime risk of heart-related complications. Subtle heart abnormalities can be present even~     at a young age in these patients and may predispose them to heart failure and ultimately~     premature death. There is emerging evidence that type 2 diabetes can be reversed with weight~     loss. We propose that weight loss can also reverse the fatty changes seen in the liver and~     heart in these patients, and in turn lead to improved heart function.~      This project aims to identify how type 2 diabetes causes changes in the heart in young~     people with type 2 diabetes by performing detailed scans and other tests of the heart's~     structure and function. In addition we will attempt to see if the heart's pumping function~     can be improved, either by a weight loss program with a special low calorie diet, or by a~     structured program of exercise. This will be compared with the usual standard diabetes care.~      As well as looking to see if the heart's function can be improved with the intervention, we~     also aim to identify what the mechanism of any improvement would be. We suspect that changes~     in the amount of fat within the liver and the heart may be responsible, and will measure~     these at the beginning, end and in some patients halfway through the study to explore~     possible mechanisms amongst other clinical variables (e.g. HbA1c)~   "
35615|NCT02590809|"~     Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized~     by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is~     observed within the left ventricle which is named left ventricular outflow tract obstruction~     (LVOTO). This phenomenon can occur at rest or during exercise and is associated with~     symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life~     adaptation. To now, medical or interventional treatments such as betablocacker, calcium~     blockers or septal alcoholisation or surgery present with a limited efficiency. Recent~     studies from investigators group revealed new concepts about the role of venous return to~     the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular~     constriction, could improve symptoms of HCM patients by reducing LVOTO.~   "
35616|NCT02590796|"~     The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to~     determine the performance (sensitivity and specificity) of a smartphone application (DelApp)~     to identify delirium in the whole inpatient sample. The study also aims to determine the~     performance (sensitivity and specificity) of the DelApp to discriminate between delirium~     (with or without dementia) and dementia (without delirium).~      The purpose of the Phase C study is to determine the efficacy of the DelApp software~     application in detecting delirium in unselected patients in an inpatient sample and to~     determine the performance of the DelApp to discriminate between delirium and dementia. The~     study also aims to explore the performance of the DelApp in tracking change in cognitive~     function.~   "
35617|NCT02590783|"~     Pelvic ring fractures in the elderly are associated with high morbidity during standard~     conservative treatment due to immobility. Furthermore the risk of long term dependence even~     after the fracture has united is high. In analogy to the treatment of hip fractures in a~     similar patient population, patients might benefit from surgical treatment due to a~     reduction in pain and early mobilization.~   "
35618|NCT02590770|"~     The purpose of this study is to determine whether giving gaze-contingent feedback is an~     effective attention modification procedure, helping in the treatment of social anxiety~     disorder (SAD)~   "
35619|NCT02590757|"~     This study is a randomized controlled study to compare if a a non-invasive neurally adjusted~     ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure~     (N-CPAP) after extubation in infants' < 30 weeks of gestation.~   "
35620|NCT02590744|"~     This study is a single-center, prospective, randomized, controlled trial. To investigate if~     preoperative using of eye patch will decrease emergence agitation, and to provide a better~     method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.~   "
35621|NCT02590731|"~     Introduction: Femoral neck fracture is a devastating injury with serious medical and social~     consequences. One third of these patients have some degree of impaired cognitive status.~     Despite of this, a high proportion of hip fracture trials exclude patients with cognitive~     impairment. The investigators aimed to evaluate whether moderate to severe cognitive~     impairment could predict walking ability, quality of life, functional outcome, reoperations~     and mortality in elderly patients treated with hemiarthroplasty.~      Methods: This cohort study included a consecutive series of 188 patients treated with~     hemiarthroplasty for an displaced femoral neck fracture. Patient were assessed for estimated~     preoperative and 1 year postoperatively with regard to walking abilities, cognitive status,~     quality of life with EQ-5D and hip function with Harris hip score.~   "
35622|NCT02590718|"~     The study is carried out in a prospectively randomly controlled way. In the context of~     acknowledgement and understanding from parents, by comparing with traditional process (lying~     without the pillow and fasting water and food for four hours following lumbar puncture), an~     optimized postoperative management (lying without the pillow for half an hour following~     lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The~     face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain~     after lumbar puncture. Any postoperative condition will be recorded and analyzed. A~     questionaire about bad memory during lumbar puncture for all parents and children will be~     investigated in order to establish an optimized lumbar puncture management process.~   "
35623|NCT02590705|"~     The study is carried out in a prospectively randomly controlled way. In the context of~     acknowledgement and understanding from parents, by comparing with traditional process(no~     anesthesia), lidocaine surface anesthesia is randomly selected. All children will be~     evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale~     to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the~     lumber puncture will be recorded and analyzed. A questionnaire about bad memory during~     lumbar puncture for all parents and children will be investigated in order to establish an~     optimized lumbar puncture management process.~   "
35624|NCT02590692|"~     The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety~     of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in~     patients with advanced, dry age-related macular degeneration.~      Primary Objective:~      • To test the safety and tolerability of CPCB-RPE1 during and after subretinal implantation~     in patients with geographic atrophy with evidence of involvement of the central fovea.~      Secondary Objective:~      • To assess visual acuity, visual field, and retinal function after CPCB-RPE1 implantation.~     Implanted and fellow eyes will be compared post-implantation to assess the ability of the~     implant to prevent disease progression.~      Exploratory Objectives:~      • To assess the feasibility of measuring the change in area of geographic atrophy over time~     using spectral domain optical coherence tomography or fundus autofluorescence.~   "
35625|NCT02590679|"~     Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional~     Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet~     porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the~     multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for~     percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and~     native right ventricular outflow tract (RVOT) after surgical repair of RVOT.~   "
35636|NCT02590536|"~     This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler~     velocity indices of the umbilical arteries in patients with placental insufficiency and~     fetal growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those~     patients.~   "
35626|NCT02590666|"~     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of~     endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently~     available. Among Others bipolar systems and microscissors or graspers, both of theme make~     part of routine clinical practice and are universally accepted.~      The aim of the study is to compare the efficacy of bipolar resection energy polypectomy~     versus microscissors or graspers These procedures assume a lower cost and are associated~     with a lower surgical risk due to their realization without anesthesia .~      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of~     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique~     with a high percentage of resection and high degree of satisfaction of patients~   "
35627|NCT02590653|"~     The primary goal~      • To assess the effect of atorvastatin in patients treated since the first 24-96 hours of~     the disease on the parameters of global and regional myocardial deformation in the infarcted~     area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48~     weeks of treatment;~      The secondary goals. To evaluate the effect of treatment:~        -  on the parameters of the global and regional myocardial deformation in the intact area~          on day 7, on 12, 24, 36 and 48 weeks of treatment;~        -  on the parameters of the global and regional myocardial deformation depending on the~          degree of coronary blood flow restoration by thrombolysis in myocardial infarction~          (TIMI)~        -  on systolic and diastolic left ventricular function in the presence of initial~          impairments, or absence of the negative dynamics of these parameters in case of normal~          baseline values;~        -  on the clinical diagnostic criteria for the development or progression of heart~          failure;~        -  the dynamics of the duration and extent of myocardial ischemia according to the daily~          ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;~        -  the appearance of new prognostically significant cardiac arrhythmias~        -  on the pulse wave velocity~        -  the thickness of the intima-media complex (IMT); 200 patients are planned to be include~          in a randomized, single-center, open, prospective, controlled clinical trial, the~          enrollment will be held at the Department of Therapy of Medical Institute of Penza~          State University.~      Definition of the study group:~      The patients with STEMI (myocardial infarction with ST-segment elevation) will be included~     in the study~        -  Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;~        -  Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned~          number of patients: Pre-Screening - 300 subjects; screening and randomization - 200~          subjects.~      Patients will be randomized by random number generation to include in the group 1 or 2. All~     included patients will be on the standard basis therapy of the coronary artery disease,~     according to the national recommendation.~   "
35628|NCT02590640|"~     The goal of this study is to determine if a specific experimental brain stimulation~     technique can be used as a non-invasive way to reduce cigarette cravings in current smokers.~     This study plans to learn more about the way an experimental technique called transcranial~     magnetic stimulation (TMS) affects a specific part of the brain, called the insula. Some~     research suggests that this part of the brain plays an important role in craving. The~     investigators plan to study the effects of TMS using standard surveys and magnetic resonance~     imaging (MRI) of subjects' brain.~      For interested participants, this study requires a single 3 hour appointment, which will~     include MRI of the brain as well as TMS.~   "
35629|NCT02590627|"~     Drug efficacy testing is one of the most important tasks that is routinely undertaken by the~     National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World~     health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT)~     and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently,~     Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and~     Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine~     (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is~     revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked~     as an alternative ACT to be used together with ALu. However, efficacy and safety data of~     DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to~     assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable~     the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria~     treatment guidelines as the second line drug for the treatment of uncomplicated malaria in~     the country.~   "
35630|NCT02590614|"~     Determine differences in serum vitamin D metabolism by genetic ancestry.~   "
35631|NCT02590601|"~     Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young~     women in the puerperal period. Thus far, no specific treatment has been approved to treat~     this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart~     failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of~     survivors have persistent chronic heart failure leading to disabling symptoms and decreased~     quality of life.~      Animal studies have suggested that prolactin is central to the development of PPCM.~     Prolactin has pro-inflammatory and anti-angiogenic effects that may promote PPCM.~     Bromocriptine, a central dopamine agonist known to decrease prolactin levels, might thwart~     its deleterious effects in women suffering from PPCM. Following this rationale,~     bromocriptine should improve myocardial function in women suffering from PPCM and thus,~     improve cardiovascular outcomes and healthcare outcomes.~   "
35632|NCT02590588|"~     The investigators expect to enroll 15 participants with relapsed or refractory~     IgM-associated AL amyloidosis onto this Phase II clinical trial. Idelalisib will be~     self-administered orally at a dose of 100 mg twice daily (may be increased to 150 mg (one~     tablet) twice daily after 3 months at investigator discretion). Participants will be treated~     until disease progression, unacceptable toxicity, or decision to withdraw from the trial.~     Disease evaluations will be performed every three months until disease progression.~   "
35633|NCT02590575|"~     The purpose of this study is to test the effectiveness of a membrane gas exchange device in~     the venovenous circulation of a continuous renal replacement therapy for the purpose of CO2~     elimination and pH compensation. Thus, the primary endpoint is the modification of the PaCO2~     and/or the ventilator settings (tidal volume VT and plateau pressure Pplat).~   "
35634|NCT02590562|"~     This observational study will describe the treatment patterns of usage of biological DMARDs~     in routine clinical practice and the demographics and RA disease characteristics in patients~     suffering from rheumatoid arthritis. Patients will be recruited and examined the same day~     when recruited. There will be no follow up visit or treatment period only one visit in this~     study.~   "
35635|NCT02590549|"~     A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert~     Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus~     safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al.~     in 2003, has become a standard treatment for progressive keratoconus to slow or possibly~     stop progression of disease.~      The formation of the stromal pocket during MyoRing implantation offers the opportunity for~     simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to~     provide combined treatment in patients with progressive keratoconus.~   "
35639|NCT02590497|"~     This pilot clinical trial studies the correlation between the genetics and brain images of~     patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a~     tumor are an important way to predict how well it will respond to treatment. Imaging, using~     magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may~     also provide information that helps doctors predict how brain tumors will respond to~     treatment. If MRI can provide doctors with similar information about the tumor as the~     tumor's genes, it may be able to be used to predict tumor response in patients whose tumors~     cannot be reached by surgery or biopsy to get tissue samples.~   "
35640|NCT02590484|"~     Placenta previa and placenta accrete carry significant maternal and fetal morbidity and~     mortality. Several techniques have been described in the literature for controlling massive~     bleeding associated with placenta previa cesarean sections. The aim of this study is to~     evaluate the efficacy and safety of the use of the cervix as a natural tamponade in~     controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.~   "
35641|NCT02590471|"~     Comparison of two methods for revascularization of the superficial femoral artery: stenting~     of the superficial femoral artery vs. stenting of the superficial femoral artery~     supplemented with fasciotomy in Hunter canal in patients with steno-occlusive lesion of the~     femoro-popliteal segment of TASC C, D.~   "
35642|NCT02590458|"~     The goal of this clinical research study is to test if a short breast MRI scan (about 10~     minutes) can be used for breast cancer screening in high risk people and to learn if it is~     as effective as a routine breast MRI scan (30-60 minutes).~   "
35643|NCT02590445|"~     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain~     stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most~     effective treatment for refractory OCD. However, the affecting area of traditional~     electrodes is limited and not specific to VC/VS. The investigators designed a novel~     electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in~     ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm~     contact)that can be implanted in ventral capsule simultaneously, which the investigators~     believe will be more effective due to better compatibly with anatomical features of target~     area. This trial is to evaluate the effectiveness and safety of this approach.~   "
35644|NCT02590432|"~     The primary objective of this study is to assess the potential of linaclotide treatment to~     induce the development of anti-drug antibodies (ADAs). The secondary objectives are to~     provide additional evidence supporting the long-term safety and efficacy of linaclotide in~     adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation~     (CIC) patients and to evaluate lower doses of linaclotide.~   "
35645|NCT02590419|"~     Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy~     surgeries by considering white matter tracts, and considering whether the technology results~     in improved clinical outcomes.~   "
35646|NCT02590406|"~     The risk of complication associated with airway in obese patient is important. The result of~     pre-oxygenation gives the clinician a prolonged non-hypoxic apnea time. The relation between~     FRC and non-hypoxic apnea time has been correlated. However, the best condition to~     accomplish the pre-oxygenation in morbidly obese patient has yet to be described in the~     medical literature. A study previously done in our hospital (EPO2-PV) compared the effect of~     different positions and ventilation modes on the FRC in the laboratory. A significant~     difference has been established on the FRC between the inverse Trendelenburg position with~     positive pressure ventilation and the head up (beach-chair) position without positive~     pressure. The current study, EPO2-A is designed to compared the two positions and~     ventilation modes during the induction of general anesthesia on morbidly obese and correlate~     the difference in FRC to difference in apnea time.~   "
35647|NCT02590393|"~     The purpose of this study is to learn more about the nicotine and non-nicotine chemicals~     that are part of e-cigarettes and their effects on cigarette smokers by assessing smokers'~     experiences with different e-cigarettes using a battery of self-report, biochemical, and~     behavioral indices. This is not a smoking cessation study; smokers will not be asked to quit~     smoking, and e-cigarettes will not be used as a medical device or therapy.~   "
35648|NCT02590380|"~     Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and~     sagittal correction of the adolescent idiopathic spine deformity in comparison to the side~     loading DePuy Synthes USS II pedicle screw system.~   "
35649|NCT02590367|"~     The purpose of this study is to estimate the usefulness and safety of HD6610 granule for~     oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and~     safety of the treatment algorithm for 64 patients with colorectal cancer by evaluating the~     side effects and degree of improvement of subjective symptoms.~   "
35650|NCT02590354|"~     HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable~     viral load will be recruited in four Belgian HIV reference centers. Selected patients will~     undergo a two-step screening in which a viral reservoir measurement will be performed and~     among those with a very low viral reservoir an analytical treatment interruption of their~     longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will~     receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks~     post intervention.~   "
35651|NCT02590341|"~     MYKKE is a prospective multi-center registry for children and adolescents with myocarditis.~     The aim is to generate prospective multi-center data on epidemiology, diagnostics, and~     therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic~     and therapeutic approaches for this myocardial disease.~   "
35652|NCT02590328|"~     The goal of the proposed research is to observe the prevalence and establish the validity of~     a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used~     is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs)~     that is absent in SCID patients, thus correlating with the disease.~   "
35756|NCT02588976|"~     The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform~     kaolin-based activated clotting time as routine monitor of heparin therapy in patients~     undergoing cardiac operations. In addition, the device allows the assessment of the~     patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT~     analyzer (S2) has been developed. As part of the routine management using S1, tests are also~     performed on S2. Results are entered into the cardiac surgery data base of all cardiac~     surgery patients and analyzed.~   "
35653|NCT02590315|"~     Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis~     (DBT) is more sensitive and more specific than conventional digital mammography (DM).~     However, large randomised controlled trials (RCTs) are needed to confirm these promising~     results. Furthermore, potential side effects of DBT in the screening setting have to be~     properly evaluated. In particular, the major concern is about overdiagnosis and its~     consequences; overdiagnosis refers to the detection of cancers at screening, which would not~     have become clinically apparent in the woman's lifetime.~      This RCT was designed to compare benefits and harms of DBT in a population-based screening~     program with conventional DM. The primary outcome parameter will be the difference between~     the two tests in rates of advanced cancers detected at the subsequent round and interval~     cancers (within the first two years after the study screening round). Secondary outcomes~     measures will be diagnostic performance indicators for organised breast screening (i.e,~     cancer detection rate, recall rate, false positive rate, positive predictive value),~     parameters used in cost-effectiveness analysis, pathologic and biological characteristics of~     screen-detected cancers.~   "
35654|NCT02590302|"~     The overarching goal of this project is to improve timely access to appropriate mental~     health (MH) care for children and youth. The investigators will conduct and rigorously~     evaluate implementations of this pathway in four exemplar hospitals and associated CMHA~     dyads within a local health region. Outcomes-based validation of this pathway is important~     for effective adoption in other communities. A multiple baseline study design and conduct~     interrupted time-series analysis will be used to evaluate whether the EDMHCP has resulted in~     improved health care utilization, medical management, and health sector coordination. To~     ensure EDMHCP feasibility in various settings, implementation will occur in four exemplar~     hospital-community dyads with different workflows and patient populations.~   "
35655|NCT02590289|"~     To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of~     BBI-5000 capsules in healthy adult subjects.~   "
35656|NCT02590276|"~     The project focuses on C9orf72, the most frequent genetic form of frontotemporal dementias~     (FTD, or frontotemporal lobar degeneration, FTLD) and amyotrophic lateral sclerosis (ALS).~     FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's~     disease. Behavioural and cognitive impairments progressively lead to dementia. ALS produces~     progressive muscle weakness leading to the death in 2 to 4 years. Since 2006, major~     discoveries have linked FTLD and ALS:~        1. TDP-43 aggregates in neurons and~        2. C9orf72 mutations is a major genetic cause in both disorders.~      Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU. C9orf72~     mutations (associated to FTD-TDP) are the most frequent genetic causes of FTD (15%), FTD-ALS~     (65%) and ALS (40%).~      FTD is difficult at an early stage; and no clinical, biological or imaging features can~     predict the underlying pathology in living patients. Therapeutic perspectives emerged~     against tau aggregation, progranulin deficit and C9orf72 expansion (antisense).~     Presymptomatic carriers of genetic FTD would benefit, before onset of symptoms, from these~     therapeutic that would delay or prevent the disease. At this step, it becomes crucial to~     develop markers to know how many years before symptoms, does the pathological progress~     begin, to treat the patients at the most early stage of the disease. Markers are also needed~     to predict the pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials~     targeting specific pathological lesion.~   "
35657|NCT02590263|"~     This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety~     of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health~     Organization (WHO) grade III or IV malignant glioma.~   "
35658|NCT02590250|"~     This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of~     BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due~     to neurogenic detrusor overactivity or overactive bladder.~   "
35659|NCT02590237|"~     The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope~     performs as well as direct laryngoscopy for intubating small children and infants.~   "
35660|NCT02590224|"~     Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting~     22% of pregnant women in industrialized countries and 52% in non-industrialized countries.~     Iron deficiency anemia during pregnancy is associated with increased maternal as well as~     fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss.~     Therefore, routine iron supplementation during the second half of pregnancy has been~     recommended once daily. Others, however, support a selective iron supplementation only for~     women with iron deficiency anemia, in order to avoid the increased risk of~     haemoconcentration associated with routine iron supplementation. Unfortunately, compliance~     to either iron-supplementation programs, especially among pregnant women, is poor, due in~     part to the side effects associated with these preparations.~      Currently, there are many iron preparations available containing different types of iron~     salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse~     drug reactions found with these preparations are mainly gastrointestinal intolerance like~     nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully~     reacted chelated amino acid form of iron) rarely make complication.~      Product resulting from the reaction of a metal ion from a soluble salt with amino acids to~     form coordinate covalent bonds, the resulting molecule is called as chelate and chemical~     bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally~     nutritionally functional chelate it is an amino acid fully reacted chelate which is formed~     by the binding of two molecules of glycine to one Fe2+ atom.~   "
35661|NCT02590211|"~     The PERHAPS project aims to fill two gaps in the scientific literature: on the one hand,~     studying the clinical and cognitive particularities of poker-related problems, and on the~     other hand, studying poker skill as a combination of multiple cognitive and emotional~     abilities. The underlying clinical aim is to develop a cognitive remediation therapy program~     dedicated to pathological gamblers.~   "
35662|NCT02590198|"~     Neonatal bacterial infection remains a serious pathology in industrialized countries despite~     the use of prophylaxis measures for group B streptococcus (GBS) (peri-partum antibiotic in~     women with GBS colonization), which was implemented in the United States in 1996 and in~     France in 2001 and has led to a dramatic decrease in the incidence of neonatal bacterial~     infections. However, early onset neonatal infection (EONI), which is defined as an infection~     occurring during the first 6 days after birth (as opposed to late onset neonatal infections~     (LONI) occurring between days 7-89), is still one of the leading causes of neonatal~     morbidity and mortality. Physicians consider EONI a significant diagnostic and therapeutic~     emergency due to the potential for sudden onset and rapid evolution of sepsis in newborns~     with immature immune systems. Currently, in France, detection of EONI is based on national~     consensus guidelines published in 2002 (ANAES recommendations). There are broad indications~     to provide empirical antibiotic treatment pending diagnostic confirmation through different~     complementary exams. To ensure that every infected newborn is diagnosed, biological~     assessments are often repeated and result in the use of invasive and painful procedures,~     anemia and financial concerns. Moreover, in cases of abnormal biological results, many~     newborns are subjected to intravenous (IV) antibiotic treatments requiring hospitalization~     and separation from their mother. However recent studies have shown that antibiotics can~     have a potentially deleterious effect on the neonatal digestive microbiota and result in the~     appearance of antibiotic-resistant bacteria, with possible long-term consequences on the~     health of the child.~      Procalcitonin (PCT) is a calcitonin prohormone secreted from the parenchymal tissues. This~     marker of inflammation has been shown to be a valuable diagnostic marker for bacterial~     infection in adults and in children. It also seems to be a reliable marker for neonatal~     bacterial infection, which would make it useful in the detection of EONI. Because~     physiological levels of PCT vary during the first days of life, possibly due to postnatal~     intestinal bacterial colonization, levels of this marker are difficult to interpret in the~     early neonatal period. However, in a study of 2151 newborns with suspected EONI, Nicolas~     Joram et al. found that PCT obtained from the umbilical blood cord, prior to newborn~     intestinal colonization, bypasses this postnatal physiological peak of PCT and effectively~     constitutes a discriminant marker to distinguish between infected and healthy infants using~     a cutoff value of 0.6 ng/ml.~      Subsequent to this pilot study, several studies on PCT in umbilical blood cord confirmed its~     good diagnostic performance for EONI, particularly when included in a diagnostic algorithm.~     This marker could contribute to a better estimation of EONI risk in order to limit the use~     of unnecessary complementary exams and prescription of antibiotics and their associated~     short- and long-term side effects in healthy newborns.~      Therefore, in this study, the investigators propose to test the diagnostic value of a~     PCT-based algorithm in newborns suspected of having EONI. The investigators hypothesize that~     this algorithm is as efficient as those currently used (ANAES), but will limit coinciding~     biological exams and exposure to antibiotics during the neonatal period.~   "
35757|NCT02588963|"~     The aim of this study is to evaluate the influence of Primary and Secondary Prevention of~     Respiratory Infections in children up to 3 years-old attending daycare.~   "
35874|NCT02587442|"~     This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study~     designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This~     study is to be conducted at two clinical centers and in conformity with Good Clinical~     Practice (GCP).~   "
35663|NCT02590185|"~     Regarding the direct costs and the social value of depression, the decision of an~     antidepressant treatment prescription must be optimized as much as possible. The development~     of a personalized medicine in psychiatry may reduce treatment failure, intolerance or~     resistance, and hence burden and costs of affective disorders.~      There is hope that biomarkers will be found to guide treatment selection. It might be of~     decisive interest to be able to assess an individual's metabolism activity. We propose here~     to explore the relationship between the activity of drug-metabolizing enzymes (DME) and~     transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will~     focus on venlafaxine (V) that provides a reasonable second-step choice for patients with~     depression and is used extensively in psychiatric practice, and the metabolism of which~     involves several cytochromes (CYP) P450 enzymes and the transporter P-gp.~      Thus, the primary objective of this study is to study the correlation between the~     concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability~     assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20~     despite 4 weeks of V at 150mg or less~   "
35664|NCT02590172|"~     In France, Intensive Medicine is carried out in three types of structures: intensive care~     units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as~     intermediate structures between conventional care units and intensive care units, these~     units are assigned to the care of patients whose conditions and treatment are fear the~     occurrence of one or more critical failures requiring to be monitored, or whose condition,~     at the end of one or more critical failure is too severe or unstable to allow a return to a~     classical inpatient unit.~      Thus, USC represent a milestone in the journey of patients whose condition is critical:~     patients from the emergency services, patients in the immediate postoperative period, coming~     out of intensive care patients, or finally in conventional hospitalization patients whose~     condition s 'worse. The creation of the USC is not subject to authorization but must be~     contractualized between the hospital and the Regional Health Agency (ARS) because it is~     resource intensive. Organizations and their operating modes are guided by the~     recommendations of the French Society of Anesthesia and Intensive Care (SFAR), and the~     Society of French Language Resuscitation (SRLF) published in 2005.The US establishment has a~     beneficial effect on the quality of care and the care pathway of patients at risk shown by~     the reduction in morbidity and mortality, the rate of admission and / or USC readmission of~     length of stay and hospital stay costs.~      It is possible to objectify provided first establish an inventory on the activity of these~     units and the patient base supported. To judge the benefit of the assumption by the USC, it~     is necessary to assess the adequacy of patients managed with an updated specification and~     defined by a group of experts.~   "
35665|NCT02590159|"~     Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive~     sleep apnea for the purpose of obtaining safety and efficacy data~   "
35666|NCT02590146|"~     This study will examine the use of non-pharmacologic pain control techniques and~     pain-management counseling as an additional tool for reducing pain during first trimester~     aspiration abortion.~   "
35667|NCT02590133|"~     We define refractory nasopharyngeal carcinoma as the following: recurrence with radiation~     brain injury after radiotherapy, recurrence after the second or more courses of~     radiotherapy, standard treatment failure after recurrence, and first-line treatment failure~     after multiple distant metastasis.~      There is no standard treatment for refractory nasopharyngeal carcinoma. Platinum plus 5-Fu~     is the classic regimen for primary treatment of nasopharyngeal carcinoma.~      Endostatin is a multiple targeted angiogenesis inhibitor acting on tumor associated~     neovascular endothelial cells, normalizing the morphology and function of tumor vasculature,~     and indirectly leading to the quiescence or reduction of tumors.~      The purpose of this phase II clinical trial is to determine the efficacy and safety of~     nedaplatin plus continuous low dose 5-Fu intravenous infusion combined with endostar®~     (Recombinant Human Endostatin Injection) continuous intravenous infusion compared with~     nedaplatin plus continuous low dose 5-Fu intravenous infusion alone in refractory~     nasopharyngeal carcinoma.~      The study hypothesis is that nedaplatin plus continuous low dose 5-Fu intravenous infusion~     combined with endostar® continuous intravenous infusion is effective and safe in refractory~     nasopharyngeal carcinoma.~   "
35668|NCT02590120|"~     The purpose of this study is to evaluate amino acid absorption with two different type of~     proteins.~   "
35669|NCT02590107|"~     This clinical trial studies the use of early oral supplementation in improving nutritional~     status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional~     status in participants undergoing hematopoietic stem cell transplant has been linked to~     decreased outcomes such as increased length of hospital stay and increased time to~     engraftment (an important milestone in transplant recovery). Early oral supplementation may~     increase nutritional status and help to promote a positive outcome in participants~     undergoing transplant.~   "
35670|NCT02590094|"~     Proliferative diabetic retinopathy patients requiring pars plana vitrectomy receiving~     preoperative 0.625 mg intravitreal bevacizumab 3-10 days prior to vitrectomy will have~     similar surgery times and similar intra-operative and postoperative complications to~     subjects who receive preoperative 1.25 mg intravitreal bevacizumab at both 3-5 days, and~     6-10 days prior to vitrectomy.~   "
35671|NCT02590081|"~     This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy~     and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in~     wash back procedure during haemodialysis in patients with end stage renal failure (ESRF)~     with respect to systolic blood pressure control over 3 months period.~      The primary objective is to establish efficacy of 5% dextrose solution compared with normal~     saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in~     subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives~     include monitoring the change in body weight, thirst level and body fluid volume.~   "
35758|NCT02588950|"~     This purpose of this two-part study is to measure how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of it. In Part A, each participant~     will receive two treatments, a single dose and a continuous dose of U-500R insulin, both~     administered just under the skin. Participants who complete Part A will continue into Part B~     where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice~     or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks~     including initial screening and follow up.~   "
35672|NCT02590068|"~     This study aims to identify the innate and adaptive immune response to zoster vaccination.~     Half of the participants will be individuals with chronic hepatitis C, while the other half~     with healthy volunteers.The innate immune signature elicited by Zoster vaccination will be~     characterized by RNA-seq analysis of pre- and post-vaccination RNA from whole blood. We will~     compare fold changes in gene expression profiles pre- versus post-vaccination in each~     individual, as well as between the two arms of the study. RNA-seq will be used to assess~     innate immune activation by evaluating the changes to the expression levels of~     interferon-stimulated genes pre- and post-vaccination. Adaptive immune response will be~     determined by the traditional correlates of protection used in previous Zoster clinical~     studies in addition to flow cytometry24. Correlates of protection include antibody response,~     interferon gamma production and the frequency of responder cells post- vaccination24. For~     antibody production, we will perform Zoster glycoprotein ELISA (gpELISA) targeting IgG/IgM.~     The number and frequency of responder cells will be characterized by flow cytometry.~   "
35673|NCT02590055|"~     It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with~     carcinoma of unknown primary.~   "
35674|NCT02590042|"~     A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using~     ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing~     stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from~     a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be~     administered subcutaneously via injection, with or without unprocessed autologous fat (fresh~     or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary~     objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of~     subjects with soft tissue defects or abnormal wound healing who are still symptomatic~     despite being managed by conventional therapies.~   "
35675|NCT02590029|"~     The purpose of this randomized study is to determine the impact of three different types of~     psychosocial support delivered by social workers to patients reporting uncontrolled pain~     during a hospital stay. This study will examine the differential effects of brief~     mindfulness training, therapeutic suggestion, and psychoeducation for patients reporting~     uncontrolled pain.~   "
35676|NCT02590016|"~     Pregnant women with gestational diabetes who are treated with insulin and their daily~     insulin dose is 30 IU or more will be randomized into two groups. Active treatment group~     will recieve insulin-glucose-infusion during labour. In the observational group, blood~     glucose level during labour will be monitored and insulin-glucose-infusion is started only~     if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia~     between the two groups and that the proportion of observational group participants that need~     infusion is low.~   "
35677|NCT02590003|"~     This study will enroll elderly patients with advanced non-small cell lung cancer who are at~     high risk of developing chemotherapy toxicity (side effects). Patients will receive~     treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel~     or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity~     will be compared in the two treatment groups to determine the best treatment strategy for~     this group of patients.~   "
35678|NCT02589990|"~     The study investigates the effect of maximal strength training on muscular strength and~     power in different age groups from 20 to 80 year old. It also relates the training~     adaptations to different known genes such as angiotensin I-converting enzyme (ACE) and~     Alpha-actinin-3 (ACTN3). Participants will complete an eight weeks, three times per week~     training intervention of maximal strength training with a pre-post design. In addition,~     blood samples will be collected for the analyses of genetic variances.~   "
35679|NCT02589977|"~     Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and~     devices have been demonstrated to reduce mortality, no such therapies have been identified~     in HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms~     of HFpEF.~      Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and~     increased myocardial fibrosis have been postulated to play important pathophysiologic roles~     in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with~     altered myocardial energy utilization and energy starvation. However, there are limited~     data regarding energy starvation in HFpEF and the relationships between myocardial blood~     flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes~     of this study are to use non-invasive cardiac imaging techniques to describe cardiac~     structure, function, blood flow, energetics, and fibrosis, and the relationships between~     these in order to better understand underlying mechanisms in HFpEF.~   "
35680|NCT02589964|"~     The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of~     antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in~     pneumonia patients.~   "
35681|NCT02589951|"~     The purpose of this study is to determine the prevalence, etiology, and timing of missed~     Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency~     physicians, as well as to determine admission rates for SMI soon after discharge from an~     inpatient psychiatry admission.~   "
35682|NCT02589938|"~     This study is being done to find out what effects, good and/or bad, acupuncture has on~     participants and their xerostomia caused by radiation therapy for the treatment of the~     cancer.~   "
35683|NCT02589925|"~     Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and~     basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of~     Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having~     mild to moderate dementia.~   "
35684|NCT02589912|"~     The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for~     restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device~     has been discontinued, meaning that there is no commercially approved device currently~     available. The replacement model, the ABI541 (an unapproved device), is being investigated~     in ongoing clinical trials. A compassionate use arm of a clinical trial allows patients with~     NF2 to be implanted with this new ABI.~   "
35759|NCT02588937|"~     The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell~     ODT. in chronic hepatitis B Patients.~   "
35685|NCT02589899|"~     A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it~     from other tissue types has been developed in a porcine model, by analysing a complex~     impedance dataset based on multiple measurement frequencies. It must now be confirm that the~     previous results are applicable in humans. Measurements from 24 predefined needle positions~     will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new~     algorithm to detect nerve tissue will be developed based on these measurement results.~     Further impedance algorithms will be developed for other tissue type. The efficacy of the~     algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers~     (part B).~   "
35686|NCT02589886|"~     A randomised trial to the effect of a newly developed education and self help intervention~     for patients with a functional motor disorder on general health, quality of life, illness~     perception, symptom severity and other secondary outcome measures.~   "
35687|NCT02589873|"~     This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle~     interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an~     in-person group-based lifestyle intervention; and 2) an internet-based intervention~     delivered using an online platform with lifestyle coaching support. Eligible participants~     will be randomized equally to each intervention program (120 participants in each).~   "
35688|NCT02589860|"~     This is a pilot study to explore and identify changes in molecular processes within the oral~     mucosa that are associated with the development of oral mucositis (OM) in patients treated~     with Melphalan who undergo autologous peripheral blood stem cell transplantation.~   "
35689|NCT02589847|"~     This study will evaluate efficacy and safety information about RBX2660 for the treatment of~     recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one~     treatment with RBX2660 (microbiota suspension).~   "
35690|NCT02589834|"~     Postoperative pain management is crucial for surgical patients. Management of postoperative~     pain entails reducing painful symptoms, improving the quality of recovery and resuming~     normal daily living activities. In addition to the benefits derived from relieving~     postoperative pain in women undergoing cesarean section, prolonged immobility as a result of~     pain during puerperium is associated with risk of thromboembolic disease.~      Postoperative pain has negative physiological and psychological impact on patients'~     well-beings and delays the postoperative recovery. Pain may also impair the mother's ability~     to provide an optimal care for her infant in the immediate postpartum period. Besides that,~     it also reduces the maternal ability to breast-feed her infant effectively.~      Effective pain relief should not interfere with the mother's ability to move around and care~     for her infant, and that it results in no adverse neonatal effects in breast-feeding women.~      Non-pharmacological techniques for reduction of pain are growing rapidly. Spiritual~     intervention with listening to Quran recitations as an adjunctive therapy in the~     postoperative period is a non-pharmacological technique that is inexpensive, non-invasive~     and has no side-effects. Spiritual and Islamic implication could improve postoperative pain~     6-8 hours and 24-30 hours in Muslim patients undergoing abdominal surgery. However, there is~     limited number of published studies on the effect of spiritual and religious intervention on~     pain after cesarean section.~      Listening to Quran recitation elicits a relaxation response of calmness, mindfulness, and~     peacefulness in Muslims. Pray therapy results in optimal harmonization, which improves~     psychological, social, spiritual, and physical health status.~      The current study aims to investigate the effects of listening to Quran recitation on pain~     intensity among patients after cesarean section according to the cultural, social and~     economic differences in Egypt.~   "
35691|NCT02589821|"~     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the~     efficacy of Sulfatinib 300 mg once a day in treating advanced pancreatic neuroendocrine~     tumors.~   "
35692|NCT02589808|"~     This study will compare findings using a handheld ultrasound device (GE VScan) with those~     using a diagnostic ultrasound machine in adult patients referred for transthoracic echo~     (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London.~      The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE)~     protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick~     box' form. A different echocardiographer will then perform and report the DTTE as per~     routine practice. The results from VTTE and DTTE will be directly compared. The~     echocardiographers performing the VTTE and DTTE are all fully accredited in diagnostic TTE~     and will be blinded to each others findings.~      The study aims to recruit a total of 96 patients with an anticipated study completion date~     of November 2015.~   "
35693|NCT02589795|"~     CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity~     of two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV)~     via combined intramuscular and intradermal methods with and without electroporation, and~     boosted with recombinant HIV CN54gp140 administered by intradermal injection in healthy~     volunteers.~      The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced~     antibody responses to boosting with recombinant protein by the intradermal method.~   "
35694|NCT02589782|"~     TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III~     trial; evaluating short treatment regimens containing bedaquiline and pretomanid in~     combination with existing and re-purposed anti-TB drugs for the treatment of biologically~     confirmed pulmonary multi drug-resistant TB (MDR-TB).~   "
35695|NCT02589769|"~     A randomized controlled clinical trial comparing the effect of substitution of unsaturated~     fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal~     weight and obese subjects with elevated LDL cholesterol.~   "
35710|NCT02589574|"~     Influenza is an important cause of medical visits and worker absenteeism among healthy~     adults. Studies of healthcare providers vaccination programmes have reported a positive~     effect in lowering rates of influenza like illness and influenza related complication,~     hospitalisation and death. Nurses should receive influenza vaccination so that those~     patients who may come in contact with will not be infected by their nurses. However, the~     immunization rate among nurses is constantly low. Therefore, it is important to develop an~     intervention programmes to increase immunization of nurses. In some research on electronic~     text messaging in promoting public health showed potential of this communication system in~     preventive health behavioural change. With the use of this widely acceptable, accessible and~     convenient approach of communication, reminders of receiving influenza vaccination are sent~     to nurses involved in this study. At the same time, educational messages are sent to modify~     their perception on the positive effect of influenza vaccination, and therefore, motivate~     the nurses to receive the vaccination. The study will be conducted as a two-arm randomised~     controlled trial which the control and intervention groups will run concurrently. Nurses of~     a local hospital are invited to participate in this study. They will receive the usual~     announcement on the information of free influenza vaccination of the hospital. The~     participants of the intervention group will also receive text message reminders on details~     for free influenza vaccine and educational information. All communication occurred through~     secure, asynchronous electronic text messages. The reminders and educational information are~     developed with reference to promotion messages from the Department of Health under the~     framework of Health Belief Model so as to promote positive perception on influenza~     vaccination by the participants. Participants are invited to complete the pre and post~     questionnaires before and after the study period. The influenza vaccination status of the~     participants and their perception on influenza vaccination will be obtained. It is~     hypothesised that the participants receiving the reminders and educational information will~     more likely to receive influenza vaccine and perceived the influenza vaccination as~     important measure in protecting them from influenza. The participants of the intervention~     group will also receptive to electronic text messaging communication and education.~   "
35773|NCT02588755|"~     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)~     plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative~     resection~   "
35696|NCT02589756|"~     Obesity represents one of the most important public health challenges for the societies.~     Although excess energy intake and physical inactivity are major causes of obesity and~     cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs)~     with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on~     obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic~     reviews and meta-analyses conducted in recent years strongly support a protective~     association between eating nuts and CVD. The investigators will conduct a randomized~     controlled clinical trial in adults. The main research questions are: a. Does consumption of~     fatty fish increase levels of POPs in overweight and obese adult norwegian men and women~     compared to a control group not consuming fatty fish? b. Does consumption of fatty fish~     affect markers of cardiometabolic risks (blood pressure, lipids, glucose and CRP) in~     overweight and obese adult norwegian men and women compared to a control group not consuming~     fatty fish? c. Does consumption of nuts improve markers of cardiometabolic risks in~     overweight and obese adult Norwegian men and women compared:1. to a control group not~     consuming nuts or fatty fish and 2. to a group consuming fatty fish.~      Clinical significance of study: If an increase in POP levels is seen, and correlates with~     cardiometabolic risks, this may indicate the need to look further at a causal relation~     between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If~     eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish,~     this could be important dietary information for populations at high risk of CVD.~   "
35697|NCT02589743|"~     This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on~     occlusal surfaces previously coated with intermediary bonding layer and it determined caries~     incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal~     Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.~   "
35698|NCT02589730|"~     The purpose of this study was to explore a model suitable for the individualized diabetic~     management based on the mobile application coaching and demonstrate its effect among the~     diabetic mellitus population.~   "
35699|NCT02589717|"~     This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to~     provide atezolizumab access to participants with locally advanced or metastatic urothelial~     carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy~     regimen.~   "
35700|NCT02589704|"~     This is a single visit, non-interventional, cross sectional study about risk factors,~     etiology, nutritional status and feeding methods in CP patients.~   "
35701|NCT02589691|"~     The prevention of the occurrence of respiratory events is a constant concern in pediatric~     anesthesia, as these represent the main cause of the anesthesic mortality. These events~     occur partly during induction of anesthesia and are all the more frequent as the child is~     young.~      The French recommendations do not propose the use of neuromuscular-blocking agents in~     pediatric anesthesia. This recommendation is controversial In a recently published study, it~     has been shown that the use of neuromuscular blocking agents during induction in children~     under 2 years improves intubating conditions and reduces the incidence of hemodynamic and~     respiratory events. This monocentric study, centered on intubating conditions, does not~     allow to conclude on the influence of muscle relaxants on reduction of the respiratory~     morbidity.~      The objective of study is to demonstrate that, in children under 2 years, changing the~     anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia~     associated with respiratory events occurring during induction~   "
35702|NCT02589678|"~     Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus,~     diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to~     simulate a vaccine efficacy trial to see if single women can participate in studies that~     mimic actual HIV vaccine studies.~   "
35703|NCT02589665|"~     The main purpose of this study is to test the hypothesis that treatment with LY3074828 is~     superior to placebo in providing clinical benefit to participants with moderate to severe~     ulcerative colitis (UC). This study will also investigate how the body processes the drug.~   "
35704|NCT02589652|"~     This is a multicenter, prospective cohort study to evaluate the efficacy and safety of~     sequential combination or switch therapy of pegylated interferon alfa-2a in chronic~     hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and~     compared to those who continued on ETV therapy.~   "
35705|NCT02589639|"~     This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,~     efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with~     Type 2 Diabetes Mellitus with insufficient glycaemic control~   "
35706|NCT02589626|"~     This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study~     of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus~     with insufficient glycaemic control~   "
35707|NCT02589613|"~     The objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI. Administration of glucose as well as fructose is followed~     by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1~     (GLP-1) levels as an endogenous satiety signal in obese humans.~   "
35708|NCT02589600|"~     The goal of this study is to perform the first fracture reduction clinical trial with a~     potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term~     care population.~   "
35709|NCT02589587|"~     Morbidly obese patients exhibit impaired secretion of satiation hormones which may~     contribute to the development of obesity. Bariatric surgery is associated with weight loss~     and dramatic increase in the secretion of satiation hormones, but the underlying mechanism~     remains unknown. The investigator's goal is therefore to examine patients before and after~     sleeve gastrectomy and compare findings to lean controls.~   "
35718|NCT02589470|"~     Studies on the cognitive function have highlighted promising results concerning attention.~     In contrast, in the field of memory, the single cohort study that has been carried out, has~     not been randomised, with non comparable groups, the significant outcomes are therefore to~     be balanced.~      In this study, patients with focal and structural temporal lobe epilepsy will be randomised~     in 2 groups : the COMETE group where patients will attend a specific rehabilitation~     programme of memory and the control group where patients will benefit from a standard~     treatment.~   "
35711|NCT02589561|"~     Currently, the fitting of hearing aids is using a computer interface that allows to adjust~     the gain and compression of acoustic amplification. This adjustment is made face to face,~     patient and audiologist being located in a soundproof space to test the effectiveness of the~     hearing aid.~      However, advances in telemedicine in this context, let consider the possibility of~     addressing these hearing aids fitting via the same computer interface, but remotely~     controlled by the hearing care professional. The purpose of this study is to assess the~     ability to perform these tests no longer in front of the patient settings, but away from it,~     and without visual and sound contact other than through a computer interface.~      At the end, this project wants to show that a remote fitting is an acceptable procedure that~     provides comparable results to-face fitting in terms of speech perception, speech in noise~     audiometry, hearing loss related quality of life in order to be able to offer this type of~     strategy.~   "
35712|NCT02589548|"~     The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil.~      The purpose of the study is to gather clinical, epidemiologic and outcomes data on the~     treatment of HL, on the basis of records collected by key Brazilian institutions, through a~     centralized web-based registry of clinical data verified by central board of~     hematopathologists.~   "
35713|NCT02589535|"~     Septic shock is a systemic inflammatory response syndrome with acute circulatory failure~     secondary to a documented infection. It is the most feared complication in ICU patients,~     with a 50% mortality rate.~      The study of stem cells and their experimental use in sepsis treatment is particularly~     relevant in the international scientific research, where Italy plays an important role. In~     the vast and complex field of stem cell research, the primary aim of the current proposal is~     to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + /~     CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1)~     and stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery.~      The secondary objectives of the project are: determine cut-off values of EPCs , HIF -1 and~     SDF-1 related to sepsis score from literature and their time course variation in patients~     receiving conventional treatment according to the Surviving Sepsis Campaign guidelines,with~     or without extracorporeal hemoperfusion therapy.~   "
35714|NCT02589522|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970~     (VX-970) when given together with whole brain radiation therapy in treating patients with~     non-small cell lung cancer that has spread from the original (primary) tumor to the brain.~     ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor~     cells and shrink tumors. Giving ATR kinase inhibitor VX-970 together with radiation therapy~     may be a better treatment for non-small cell lung cancer.~   "
35715|NCT02589509|"~     The purpose of this study is to test an innovative combination of direct-attention training~     and metacognitive training in the treatment of attention impairments in Veterans with~     moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional~     problems. Enrolled participants will be randomized to receive either the direct-attention~     training or metacognitive training first and then will be crossed over to receive the~     opposite intervention. The study will consist of two treatment periods of 4 weeks and a~     post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants~     will also perform measures of complex functional activities (e.g., independent activities of~     daily living or IADLs) and neurocognitive tests of attention-control functions. Participants~     will also perform an attentional task that probes the function of three different~     attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being~     recorded in order to assess changes in brain function that may be improved by the~     rehabilitation approach. Planned enrollment will be 36 Veterans.~   "
35716|NCT02589496|"~     Gastric cancer (GC) is the second most common cause of cancer related mortality and the~     fourth most common cancer worldwide. The molecular classification of GC and the relevance of~     pre-clinical models are not well established, creating challenges in discovering novel~     molecularly targeted therapies. In order to address these issues, we conducted an integrated~     molecular data analysis of three hundred Asian Gastric tumors through the Asian Cancer~     Research Group (ACRG). We performed an integrated genomic analyses based on target~     sequencing, gene expression profiling, copy number variations, Lauren's histological~     classification, Epstein Barr Virus (EBV) status, TP53 status in three hundred GC specimens.~      We first divided GC into four subgroups based on gene expression profiling and TP53 status:~        1. epithelial MSS-TP53 inactive;~        2. epithelial MSS-TP53 active;~        3. MSI; and~        4. mesenchymal.~      With an integrative analysis with target sequencing and copy number variations, epithelial~     MSS-TP53 inactive GCs are characterized by predominantly hypermutated intestinal tumors~     (including majority of mutations in KRAS) with MLH1 loss through promoter methylation and~     MSS-TP53 active GCs are characterized by intact TP53 pathway with high frequency of EBV~     infection or frequently mutated oncogenes (e.g. PIK3CA). MSI subtype with TP53 pathway~     inactive characterized by TP53 loss through deleterious mutations in TP53 or MDM2~     amplification and further characterized by both focal amplifications in oncogenes such as~     HER2, EGFR, cMET, CCNE1 as well as large scale chromosomal gains and losses. The above~     subtypes exhibited differential prognosis with the mesenchymal subtype displaying the worst~     survival (2.2 years) and the MSI subtype the most favorable survival (5.6 years). The GC~     subtypes and their association with prognosis were independently validated in three GC~     cohorts. We additionally showed significant association of global gene expression immune~     patterns, like adaptive immune system and inflammation, as well as expression of PD-L1, with~     the genomic defined subtypes.~      In the phase Ib KEYNOTE-012 study which evaluated pembrolizumab monotherapy at 10 mg/kg ever~     2 weeks in patients with gastric cancer were recently reported. Most patients had two or~     more prior lines of therapy. In the study, 41% of evaluable patients showed tumor shrinkage.~     The overall response rate in 39 patients were 31%.~      The preliminary data showed a Not significant correlation between PD-L-1 expression and ORR~     (P=0.071).~      Given the mutual association of tumor genetic markers, gene expression and potential markers~     of response to immune therapy identified through the collaborative work between SMC and~     MERCK MSD and Lilly, we plan to perform a phase II study with integrative genomic analysis~     (whole exome and RNA sequencing) in pre and post biopsy specimens to better define those GCs~     who may benefit from pembro.~   "
35717|NCT02589483|"~     The anastomotic leaks are multivariable in its origin. The incidence varies among different~     centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be~     devastating for the patient and very costly for the health care system.~      Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.~      The future of colorectal surgery will increasingly include older patients with increased~     preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it~     suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks~     spectrum into a subclinical and therefore self-healing one.~   "
35719|NCT02589457|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir~     Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male~     volunteers.~   "
35720|NCT02589444|"~     The objective of this study is to assess the effects of a high-dose vitamin D3 on the~     composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who~     are vitamin D deficient.~   "
35721|NCT02589431|"~     Background: The purpose of the present study was to compare serum total cortisol (STC),~     salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after~     the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the~     suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency~     in patients with SS.~      Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy~     controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th~     days of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.~   "
35722|NCT02589418|"~     The investigators will assess the effects of manual acupuncture on experimental dental pain~     in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific~     autonomic nervous system (ANS) reactions.~   "
35723|NCT02589405|"~     The aim of this study is to evaluate a complete acne regimen consisting of a medication~     (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil®~     Dermacontrol Moisturizer SPF30 in patients with acne.~   "
35724|NCT02589392|"~     The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring~     moisturizer in reducing the signs and symptoms of very dry atopic skin in young children.~     Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either~     Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association~     with Cetaphil® Restoraderm® skin restoring moisturizer.~   "
35725|NCT02589379|"~     The purpose of this study is to assess the value of preoperative objective modalities such~     as endoscopic ultrasound elastography and magnet resonance imaging in predicting development~     of postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or~     malignant disease.~   "
35726|NCT02589366|"~     Part of standard treatment for endometrial cancer is to remove one or more groups of lymph~     nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the~     body throughout the lymphatic system (the tissues and organs involved in immunity, which~     aids in the fight against infection and cancer).~      The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital~     Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through~     the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery~     to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the~     cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will~     keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes~     will be sent to another doctor to view them under a microscope and see if the nodes contain~     cancer cells.~      The hypothesis is that Lymphoseek can be used safely and will be at least as effective as~     blue dye in identifying the lymph nodes that may have cancer cells.~   "
35727|NCT02589353|"~     Although salivary contents play a major role in the early stage of food digestion process,~     their role in taste perception of glucose polymers is essentially unknown. It is~     hypothesized that the differences in salivary contents, more specifically salivary amylase~     concentration and activity, influence taste perception of glucose polymers and ultimately~     eating behavior, which is related to risks in various diseases. The current project is~     designed to investigate 2 aims. Aim 1 will investigate the variation in salivary contents~     across individuals and its role in taste perception of glucose polymers. Aim 2 will focus on~     the role of salivary contents in food liking and disliking.~   "
35728|NCT02589340|"~     The primary objective of this study is to evaluate the efficacy of buspirone in combination~     with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's~     disease (PD).~   "
35729|NCT02589327|"~     Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac~     and metabolic risk. The aim of this study the effects of exercise in cardiac fat content,~     cardiac function, physical fitness, and metabolic activity in obesity.~   "
35730|NCT02589314|"~     This study will evaluate if periodontal mechanical treatment is capable to alter~     immunological and genetical parameters related to systemic health in patients with chronic~     periodontitis ant diabetes type 2.~   "
35731|NCT02589301|"~     This study will evaluate the pharmacokinetics (relative bioavailability) and~     pharmacodynamics, after single subcutaneous application, in healthy volunteers of both~     sexes, between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and~     Neulastim® (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.~      In addition to that, a pharmacodynamics comparison will be performed, through change in~     absolute neutrophil count in leukogram performed in the same time of pharmacokinetics~     analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00,~     96:00 and 384:00 hours.~   "
35732|NCT02589288|"~     The aim of this prospective, randomized , blinded study is to compare two different infusion~     techniques (continuous VS intermittent automatic bolus) to assess the effects of~     postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.~   "
35733|NCT02589275|"~     This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and~     efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of~     Fibromyalgia (FM). Patients recruits into this trial are those who have successfully~     completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Anticipated start for~     TNX-CY-F302 is for March 2016.~      Patients will not be made aware of the therapy they received during the double-blind study.~   "
35745|NCT02589119|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell~     transfer using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of~     20 million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas~     will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of~     infection and placement of a draining seton. Six weeks post placement of the draining seton,~     the seton will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per~     current clinical practice. The subjects will be subsequently followed for fistula response~     and closure for 24 months. This is an autologous product derived from the patient and used~     only for the same patient.~   "
35797|NCT02588443|"~     The main purpose of this study is to learn if adding the investigational drug RO7009789~     (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe,~     feasible, and beneficial to patients with pancreatic cancer. This study also intends to look~     at blood and tissue samples to help doctors better understand the role of the immune system~     in fighting cancer.~   "
35734|NCT02589262|"~     The study medicine is a potential future treatment for schizophrenia, an illness that~     affects the way that people think, feel or behave. It is not clear what causes~     schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the~     study medicine will activate specific sites in the brain to help correct that imbalance.~     Current treatments for schizophrenia don't work very well and can cause unpleasant side~     effects. It is hoped that the study medicine will work better, and have fewer side effects~     than existing medicines.~      In this 2 part study (Parts A and B), the primary aim is to assess how safe the study~     medicine is in healthy men, aged 18-45 years, and how much of it gets into the blood. Its~     effects on the brain will also be tested.~      In Part A, up to 24 participants will receive up to 5 single doses of the study medicine~     (AUT00206 or placebo) by mouth, either after fasting or after a high fat breakfast. The~     study medicine has never been given to humans before, so the initial doses will be small and~     the dose level will be increased as the study progresses. Participants may take up to 14~     weeks to finish the study. They'll make up to 22 outpatient visits, and stay on the ward up~     to 5 times, for 3 nights in a row each time.~      In Part B, 24 participants will receive daily doses of the study medicine (AUT00206 or~     placebo) for up to 28 days. Participants will take up to 10 weeks to finish the study.~     They'll make 6 outpatient visits, and stay on the ward for up to 30 nights, depending on how~     long we expect it to take until blood levels of the study medicine level off.~      A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study~     will take place at 1 centre in London.~   "
35735|NCT02589249|"~     The purpose of this 12-week, prospective study is to determine the effects of oral~     supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility,~     joint comfort and functional capacity in healthy overweight subjects.~   "
35736|NCT02589236|"~     This will be a double-blind, randomized, placebo-controlled, parallel group study. The~     purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in~     adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated~     with lumacaftor/ivacaftor (Orkambi™).~   "
35737|NCT02589223|"~     St. Michael's Hospital (SMH) provides service to individuals with some of the most severe~     brain injuries and intensive care needs in Canada. These patients often require prolonged~     intensive care admissions, lengthy hospital stays, involvement of many health professionals,~     and long-term support for ongoing care requirements. Many hospitals face resource~     limitations, specifically involving the health disciplines and their ability to provide~     frequent intervention.~      It has been proposed that multisensory stimulation (i.e. exposing the patient to various~     sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in~     improved responsiveness/cognitive function.~      Previous research has indicated a potential benefit for early multisensory stimulation~     intervention for patients with severe brain injury. However there is still not enough~     conclusive evidence to confirm whether the intervention is truly effective. The~     investigators are proposing a pilot randomized controlled study (placebo-controlled,~     double-blinded) to determine the feasibility and examine the effectiveness of early~     multisensory stimulation with patients following severe brain injury who remain in a coma,~     vegetative state, or minimally conscious state. Eligible patients will be randomized to a~     control group (standard care + family/caregiver education) or an intervention group~     (standard care + family/caregiver education + early sensory intervention). Data regarding~     number of patients enrolled, amount of intervention completed, percentage of outcome data~     collected, patient's level of responsiveness and cognitive function will be collected before~     and after the intervention period, using several outcome measures. The investigators hope to~     determine the feasibility of conducting this type of study within this clinical setting and~     the effectiveness of multisensory stimulation with this patient population.~   "
35738|NCT02589210|"~     A single-centered, non-randomized study with approximately 20 subjects that will be seen for~     up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and~     effectiveness will be monitored throughout the study.~   "
35739|NCT02589197|"~     MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous~     study which showed the Medial Pivot (MP) system required lower quadriceps activation than~     subjects implanted with a Posterior stabilized (PS) system preforming the same activities of~     daily living.~   "
35740|NCT02589184|"~     Determine if adding extra-gravity (sustained increase in vertical loading) during standard~     rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering~     from shoulder pain of different origin.~   "
35741|NCT02589171|"~     The purpose of this study is to compare the neoClose abdominal closure to the standard~     Carter-Thomason closure in a bariatric surgery gastric bypass population.~   "
35742|NCT02589158|"~     The purpose of this study is to look at the levels of three HIV medications: atazanavir,~     darunavir and cobicistat in the blood after drug intake has been stopped, in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs after taking them every day for 10 days. Participants will~     take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and~     cobicistat) on a second stage.~      If the participants decide to take part, the duration of the study will be up to 33 days~     plus a screening visit which will take place up to 28 days prior to the start of the study,~     and a follow up visit, which takes place 7 to 14 days after the last dose of study~     medication. This study is not randomised which means that all participants will receive all~     study medications in the same order.~      The participant and the study doctor will know which study medications the participant is~     taking at all times during the study.~   "
35743|NCT02589145|"~     The goal of this clinical research study is to find the highest tolerable dose of~     lenalidomide that can be given in combination with vorinostat, gemcitabine, busulfan, and~     melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want~     to learn about the safety and effectiveness of this combination.~   "
35744|NCT02589132|"~     Failure to Thrive negatively affects growth, cognition, behavior, and quality of life (QoL),~     which can be devastating and enduring. These outcomes are high-cost and lead to increased~     family stress and negatively affect the caregiver-child relationship. Therefore, families~     need increased access to materials that will help them understand their child's health and~     help them use new feeding behaviors to improve the child's nutrition and growth. Standard~     care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile~     app, is intended to demonstrate the clinical advantages of using mobile health technology~     (mHealth) in comparison to standard care alone.~   "
35798|NCT02588430|"~     This study is a non-invasive registry to monitor the safety and efficacy of patients using~     the CE-certified RETINA IMPLANT Alpha.~   "
35799|NCT02588417|"~     To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in~     combined spinal epidural (CSE) analgesia during vaginal delivery.~   "
35746|NCT02589106|"~     One of the most common types of 3-dimensional spinal deformities with unknown etiology in~     youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty~     progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for~     moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously,~     teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical~     constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their~     efficacy is still controversial and there are other issues, such as high pain scores. There~     is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and~     developed to correct spinal deformity, reduce the possibility of spinal curve progression,~     and satisfy the needs of the patients as well as take their psychological concerns into~     consideration.~   "
35747|NCT02589093|"~     Anesthesiology daily practice consists in management of sedation, immobility and analgesia.~     The monitoring of this last component remains largely based on indirect signs with poor~     sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an~     increased demand for more accurate analgesia monitors. Several parameters have been studied~     in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate~     variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic~     tones, and is therefore influenced by pain and analgesia.~      MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called~     PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index,~     the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number~     indicating less parasympathetic tone. It has been shown in previous studies under general~     anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and~     to increase with opioids administration.~      The purpose of this study is to show a correlation between the variation of the ANI with~     pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of~     increasing intensity. The investigators hypothesize that an increasing pain score will~     correlate with decreasing ANI values.~   "
35748|NCT02589080|"~     Amputation of a limb may result from trauma or surgical intervention. The amputation~     traumatically alters the body image, but often leaves sensations that refer to the missing~     body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain~     (PLP). Both peripheral and central nervous system factors have been implicated as~     determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and~     psychological factors (emotional stress). Recent evidence suggests that PLP may be~     intricately related to neuroplastic changes in the cortex, and that these changes may~     modulated by providing sensory input to the stump or amputation zone.~      A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory~     feedback build into a hand prosthesis to alleviate phantom limb pain.~   "
35749|NCT02589067|"~     The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus~     despite the use of systemic antibiotic treatment, due to difficulties in decolonization and~     the prevalence of antibiotic-resistant strains such as MRSA.~      This problem will be studied through a randomized, double-blind, placebo-controlled clinical~     trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S.~     aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use~     in children as its safety has been widely established, and it is readily commercially~     available. Eligible, consented subjects will be asked to participate in a baseline study~     visit in which swabs of their oropharynx and nares are obtained, and they are educated on~     the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects~     will be instructed to perform the oral rinse twice daily for seven days. Two follow-up~     visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are~     again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This~     procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of~     S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal~     decolonization among children and their caregivers, and 3) determine the genetic backgrounds~     of strains of S. aureus associated with continued colonization.~   "
35750|NCT02589054|"~     Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical~     environment to provide specific intraoperative anesthesia and postoperative analgesia.~     Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then~     sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial~     plexus block results in increased skin temperature and arterial flow within minutes.~      Although it has not been shown to reliably increase diameter or cross-sectional area of~     distal arteries, brachial plexus block does change the pattern and quantity of blood flow to~     the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius,~     the investigators suspect that the more laminar fluid dynamics are due to vascular tone.~      The investigators study aims to quantify alterations in physiology and peripheral~     vasodilator response. The investigators anticipate that axially block will significantly~     improve regional blood flow.~   "
35751|NCT02589041|"~     This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal~     Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with~     Up-and-down methodology.~      To evaluate any neurological complications, an electrophysiological assessment will also be~     performed preoperatively and at 5 weeks after surgery.~   "
35752|NCT02589028|"~     The aim of this study is to explore premeal protein-enriched bar effect in postprandial~     glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1~     (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and~     those with type 2 diabetes.~   "
35753|NCT02589015|"~     The aim of this study is to determine the correlation of neck circumference with difficult~     mask ventilation and laryngoscopy in morbidly obese patients.~   "
35754|NCT02589002|"~     In this study the effects of sucralose on insulin sensitivity, beta-cell response and~     appetite regulating hormones will be evaluated.~   "
35755|NCT02588989|"~     The aim of this project is to better evaluate the systemic right ventricular (RV) function~     in patients with transposition of the great arteries (TGA).~   "
35800|NCT02588404|"~     The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion~     in patients with prostate cancer treated with radiation and hormonal therapy.~   "
35760|NCT02588924|"~     The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine,~     Forensic Medicine of the Second University of Naples, the Section of Neurology of the Second~     University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are~     involved in the realization of a research project aimed at studying the correlation between~     environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson~     disease in order to increase the knowledge of these possible risk factors and highlight an~     eventual predictive-diagnostic meaning of possible discrepancies in the content of these~     elements; secondly the collected data could be used for assessing the association (odd~     ratio-OR) between pathologies and different risk factors (for example smoking habits,~     professional exposure and so on).~   "
35761|NCT02588911|"~     The current study was a double blind randomised controlled trial that compared~     radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as~     their own controls and who had intact great saphenous veins (GSVs).~   "
35762|NCT02588898|"~     This case-control study investigated B-vitamin and homocysteine in relation to the presence~     or the absence of type 2 diabetes and clinical signs of polyneuropathy.~   "
35763|NCT02588885|"~     This project will develop and preliminarily examine RESPECT, a trauma-sensitive~     psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic~     stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse~     histories. Patients will be recruited after being referred to pelvic floor physical therapy~     for treatment of chronic pelvic pain. Participants will complete seven sessions of~     individual cognitive behavioral psychotherapy. Physical therapy will be provided by~     clinicians who have been trained in trauma-sensitive treatment techniques. Treatment~     acceptability and outcomes will be assessed at baseline, mid intervention, post-intervention~     and follow-up via self-report measures. The RESPECT protocol is expected to be feasible to~     implement among sexual abuse survivors and to be well liked by patients. RESPECT is expected~     to reduce chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.~   "
35764|NCT02588872|"~     In this, prospective, double-blind study, patients with mild to moderate symptomatic knee~     osteoarthritis will be randomized to receive either a series of leukocyte poor,~     platelet-rich plasma or hyaluronic acid injections under ultrasound guidance. Clinical data~     in the form of subjective outcome measures will be collected pre-treatment and at four time~     intervals across a 1-year period. Synovial fluid will also collected for analysis of pro-~     and anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.~   "
35765|NCT02588859|"~     This is a multicentre, non-interventional, prospective, observational study which would be~     conducted in India to understand the usage and effect of saxagliptin as first add-on therapy~     after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were~     inadequately controlled with metformin alone and have been recently prescribed saxagliptin~     as an add-on to metformin.~   "
35766|NCT02588846|"~     Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to~     account for the relative motion of the moving prostate tumour target and the static pelvic~     nodal target for high-risk prostate cancer patients. The capability of tracking for the~     relative motion of multiple targets will ensure that all the treatment targets receive~     correct dose as prescribed by the doctor and minimise side effects to the critical organs.~   "
35767|NCT02588833|"~     The objectives of the study are to assess the safety, tolerability, preliminary efficacy and~     PK of multiple subcutaneous (SC) doses of APL-2 in subjects with paroxysmal nocturnal~     hemoglobinuria (PNH) who have not received treatment with eculizumab in the past.~      An exploratory objective of the study is to assess the pharmacodynamics (PD) of multiple SC~     doses of APL 2 when administered to PNH patients.~   "
35768|NCT02588820|"~     Pilot study to evaluate the impact of extremely early ART in the dynamics of viral~     reservoir, immune activation and inflammation in patients with HIV-1 infection of less than~     20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig~     stages III-V), to induce HIV functional cure.~   "
35769|NCT02588807|"~     The purpose of the study is to evaluate the safety of combining phospholipids with medicinal~     plants for treatment of patients with amyotrophic lateral sclerosis (ALS)~   "
35770|NCT02588794|"~     Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney~     injury in patients with severe sepsis/septic shock~   "
35771|NCT02588781|"~     Pemetrexed is an anticancer agent that exerts its action by disrupting crucial~     folate-dependent metabolic processes essential for cell replication. In vitro studies have~     shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate~     synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide~     formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo~     biosynthesis of thymidine and purine nucleotides.Pemetrexed is used as a standard~     therapeutic agent for lung cancer, pleural mesothelioma, peritoneal mesothelioma.In addition~     to these effective anti-cancer effect, Pemetrexed is not severe side effects of the~     medicine.~      Pemetrexed has been research in colon cancer. Zhang, etc., demonstrated the anti-cancer~     effect of Pemetrexed in human colon cancer Cells.~      Although sometimes made also two or more clinical studies, Pemetrexed was reported 15-17% of~     the treatment response rate in these two studies.~   "
35772|NCT02588768|"~     Background/Aim: While growing evidence supports the use of photobiomodulation therapy (PBMT)~     for performance and recovery enhancement, there have only been laboratory-controlled~     studies. Therefore, the aim of this study was to analyze the effects of PBMT in performance~     and recovery of high-level rugby players during an anaerobic field test.~      Methods: It is a randomized, crossover, double-blinded, placebo-controlled trial. Twelve~     male high-level rugby athletes were recruited in this study. No intervention was performed~     before the Bangsbo Sprint Test (BST) at familiarization phase (week 1). At weeks 2 and 3,~     pre-exercise PBMT or placebo were randomly applied to each athlete. PBMT/placebo irradiation~     was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser~     diodes of 905nm, 4 LED diodes of 875nm, and 4 LED diodes of 640nm, 30J per site -~     manufactured by Multi Radiance Medical™). Average time of sprints, best time of sprints, and~     fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at~     3, 10, 30 and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a~     questionnaire.~   "
35774|NCT02588742|"~     Delirium in older patients is associated with increased mortality and health care costs. And~     delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the~     most important risk factor for developing delirium. In this study, investigators will~     investigate the effect of administration of melatonin on postoperative delirium in elderly~     ICU patients.~      Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening~     from the day before surgery to the the 5th postoperation day. In contrast, patients in the~     control group are given placebo.~      Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC~     (Intensive Care delirium Screening Checklist). And secondary outcome includes~     intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood~     pressure, total amount of sedatives, total amount of analgesics, duration of mechanical~     ventilation, duration of ICU stay.~      Thus, investigators perform this study to investigate the relationship between delirium and~     circadian rhythm.~   "
35775|NCT02588729|"~     In this study, the investigators will test a new way to communicate advice on diet and~     lifestyle to women with gestational diabetes mellitus by app downloaded on women`s~     smartphone. The app wishes to motivate women to have a healthy diet, and be physically~     active. It allows automatic transfer of blood glucose measures from the glucose meter to the~     smartphone. The women will answer questionnaires during pregnancy and be followed up three~     months postpartum.~   "
35776|NCT02588716|"~     To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in~     cirrhotic patients undergoing major liver resections.~   "
35777|NCT02588703|"~     The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI~     programs for individuals with a first-time offense. Investigators will utilize a two-group~     randomized design where individuals enrolled in a DUI program with a first-time conviction~     will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150).~     Participants will be assessed at baseline, immediately post-treatment, and 6-months~     post-treatment. Recidivism data will also be collected using administrative data two years~     post-treatment.~   "
35778|NCT02588690|"~     Cardiovascular disease (CVD) is the leading cause of death world-wide in women. Despite~     current medical advances, heart disease is rising in relatively young women. Women access~     primary care differently than men, most utilizing their Obstetrics-gynecology clinic for~     primary care services. The recent implementation of the Affordable Care Act (ACA) aims to~     provide increased access to primary care services, however, women are still not~     appropriately risk stratified for CVD disease risk. Many women still are not aware that they~     are at risk for CVD. This is particularly true for the 15-44 year old female age group. Lack~     of proper risk stratification may be related to women not being properly identified or~     appropriately referred to preventive cardiovascular services for treatment of traditional~     risk factors such as diabetes, obesity, hypertension, and dyslipidemia. These traditional~     risk markers serve as examples of chronic diseases, which are not always recognized in the~     early stages and therefore not optimally managed. Furthermore, if women are not feeling ill,~     they are less likely to access their current primary care resources for preventive~     strategies. Investigators propose to risk stratify women in places where they usually~     congregate. In addition to convenience, current risk stratification is improved with the~     recent implementation of the ASCVD risk calculator. Investigators hypothesize that if women~     were properly risk stratified and referred to appropriate preventive cardiovascular risk~     clinics, more preventive strategies could be implemented, therefore reducing the amount of~     unnecessary premature disease in women. To achieve this ambitious goal, investigators~     propose a three step, demonstration project.~      The specific aims of this proposal is to:~        1. Provide women with CVD risk stratification in places where they locally convene on a~          daily basis.~        2. To evaluate the efficacy of a lay professional to adequately assess CVD risk.~        3. To evaluate if assessment of CVD risk reduces the amount of future CVD (unsure if this~          can be measured in this project).~      The specific aims:~        1. Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk~          assessment.~        2. Improve ASCVD risk scores one year follow-up.~        3. Increase heart disease awareness through marketing materials in women in Los Angeles.~        4. Develop preliminary feasibility and efficacy data for a large clinical outcome trial.~   "
35779|NCT02588677|"~     The objective is to compare the efficacy and safety of masitinib in combination with~     riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).~   "
35780|NCT02588664|"~     The purpose of this pragmatic study is to investigate whether implementation of a~     comprehensive post-acute stroke service model that integrates Early Supported Discharge~     (ESD) and Transitional Care Management (TCM) for stroke survivors discharged home improves~     functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.~   "
35781|NCT02588651|"~     This study will include patients with mature T-cell lymphoma (MTCL) that has been treated~     with at least one type of chemotherapy, but is not responding or coming back after the~     previous treatment.~      This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration~     (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases.~     Brentuximab is still being studied in clinical trials like this one to learn more about what~     its side effects are and whether or not it is effective in the disease or condition being~     studied.~      Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually~     have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the~     chemotherapy). Antibodies are proteins that are part of your immune system. They can stick~     to and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to~     a target called CD30. CD30 is an important molecule on some cancer cells (including non~     Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of~     Brentuximab Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill~     cells that the antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also~     been shown to kill cancer cells with levels of CD30 that cannot be seen by traditional~     methods.~      This study is being done to test if the study drug has an effect on Mature T cell Lymphoma~     with such low levels of a target called CD30 and how your disease respond to the study drug.~   "
35782|NCT02588638|"~     In the study, NextGen SE are on-hand a cohort comprising each 50 pediatric and 50 adult~     patients, and in which there are an unclear movement disorder or an unclear cognitive~     disorder, examines the following questions :~      Primary:~        -  Number of diagnoses made by NGS~      Secondary:~        1. restriction of the quality of life by unclear disease~        2. Cost of not purposeful preliminary diagnostics ( beyond the minimal diagnostic data set~          )~        3. Impact of the diagnosis to therapy and follow-up examinations~        4. Time to diagnosis~   "
35783|NCT02588625|"~     This is a two part study.~      The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse~     cutaneous systemic sclerosis using one dose of BMS-986020.~      The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse~     cutaneous systemic sclerosis using two different doses of BMS-986020.~   "
35815|NCT02588209|"~     This study will provide cognitive screenings for seniors age 50 and older. It will also~     investigate the benefits of two different cognitive training programs for seniors who have~     lower baseline performance on memory and/or gist reasoning tests.~   "
35784|NCT02588612|"~     This study is intended for men and women at least 18 years of age who have advanced lung~     cancer which has grown or returned after being treated. In particular, it is a study for~     subjects who have a blood test positive for HLA-A*0201, HLA-A*205 and/or HLA-A*0206 protein~     and a tumor test positive for NY-ESO-1 expression (protein or gene). The study will take the~     subject's T cells, which are a natural type of immune cell in the blood, and send them to a~     laboratory to be modified. The changed T cells used in this study will be the subject's own~     T cells that have been genetically changed with the aim of attacking and destroying cancer~     cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion. The purpose of this study is to test the~     safety of genetically changed T cells and find out what effects, if any, they have in~     subjects with lung cancer.~      Subjects will be seen frequently by the Study Physician right after receiving their T cells~     back. Subjects will then be entered into a long-term follow up in order to monitor the~     subject. Subjects will be seen every 6 months by their Study Physician for the first 5 years~     after the T cell infusion. If the T cells are found in the blood at five years, then the~     subjects will continue to be seen once a year until the T cells are no longer found in the~     blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years,~     then the subject will be contacted by the Study Physician for the next 10 years.~   "
35785|NCT02588599|"~     The purpose of this study is to determine whether low level laser therapy (LLLT) using the~     Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.~   "
35786|NCT02588586|"~     This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying~     rebound of viral load during a brief treatment interruption of standard ART, and its safety~     during a brief analytical interruption of antiretroviral therapy.~   "
35787|NCT02588573|"~     The objective of the study is to compare the overall subjective comfort profile over 8 hours~     of lens wear in two groups of habitual soft contact lens wearers (frequent replacement and~     daily disposable hydrogel lenses) when refitted into Clariti 1-Day.~   "
35788|NCT02588560|"~     In last few years, most researches about hepatic complication after chemotherapy focused on~     hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares~     can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are~     traditionally considered as relative safe to receive chemotherapy. However, two large~     retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma~     patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to~     predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to~     the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the~     association of hepatitis are still unclear.~      Some epidemiologic studies demonstrated an association between HCV infection and B-cell~     lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several~     reports showed higher prevalence of HCV infection among DLBCL patients than the controls.~     HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as~     older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the~     impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area~     of HCV but there are limited reports addressing the clinical characteristics and prognosis~     in this unique population.~      Therefore, the investigators initiate a prospective, multi-center observational study to~     clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected~     lymphoma patients treated with chemotherapy.~   "
35789|NCT02588547|"~     This study compares the efficacy of two different doses of intravenous (IV) granisetron on~     the prevention of postspinal shivering during cesarean section, in comparison with IV~     pethidine and placebo.~   "
35790|NCT02588534|"~     A single-center, open-label, randomized study with a screening period of up to 21 days.~     Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in~     the thigh to compare injection by auto-injection device to manual injection (each injection~     separated by 28 days)~   "
35791|NCT02588521|"~     This randomized, double-blind, placebo-controlled, 4 part study will assess the safety,~     tolerability, pharmacokinetics and antiviral activity of orally administered AL-794 in~     healthy volunteers (HV).~   "
35792|NCT02588508|"~     This study evaluates the effectiveness of warm packs, perineal massage and hands off, during~     labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of~     perineal tears, need of suture, perineal edema, perineal pain, use of drugs for perineal~     pain, and satisfaction with the technique used.~   "
35793|NCT02588495|"~     During surgery, there is a risk that food or liquid in the stomach might be forced back up~     the throat where it could enter the lungs (aspirate) and result in serious complications or~     even death. This is why people going for surgery are required not to eat before their~     surgery. However, in emergency situations it is often not possible to know whether a patient~     has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to~     determine if there is content in a patient's stomach and how much. This test involves an~     ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.~      The purpose of this study is to determine how accurate these measurements are. In other~     words, how good are we at detecting an empty stomach from one that has liquids, or solids in~     it. You are being asked to participate in this study because we require non-pregnant~     volunteers in order to answer the aforementioned study question.~   "
35794|NCT02588482|"~     The purpose of this study is to measure whether high-density electroencephalography can~     improve the detection of electrophysiological signs of awareness compared to conventional~     electroencephalography in post-anoxic comatose patients~   "
35795|NCT02588469|"~     The purpose of this study is to assess the effects of physical exercise, associated or not~     with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper~     airway resistance in obese teenagers. Half of the participants will undergo physical~     exercise and compression socks program, and the other half of subjects will undergo physical~     exercise program without compression socks.~   "
35796|NCT02588456|"~     This is a single center, single arm, open-label pilot study to determine the feasibility and~     safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors~     expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as~     CART22 cells) administered in split fractions, in adult patients with relapsed or~     refractory B-cell acute lymphoblastic leukemia.~   "
35801|NCT02588391|"~     The purpose of this study is to determine if different forms of child-friendly,~     computer-based puzzles and games (brain training) targeting executive function (EF) skills~     (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk~     for EF problems due to premature birth. The investigators hypothesize that children~     receiving active brain training will show greater improvements in EF and related skills~     immediately after treatment than children receiving passive brain training. The~     investigators are also interested in whether any improvements in EF and related skills occur~     or are maintained at 3 and 6 months after completion of brain training.~   "
35802|NCT02588378|"~     This prospective, non-therapeutic study will compare the relative utility of multiple ocular~     imaging modalities in the detection of the cellular immune response in patients with AMD and~     related disorders.~   "
35803|NCT02588365|"~     The purpose of this study is to determine if different forms of child-friendly,~     computer-based puzzles and games (brain training) targeting executive function (EF) skills~     (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or~     at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The~     investigators hypothesize that children receiving active brain training will show greater~     improvements in EF and related skills immediately after treatment than children receiving~     passive brain training. The investigators are also interested in whether any improvements~     in EF and related skills occur or are maintained at 3 and 6 months after completion of brain~     training.~   "
35804|NCT02588352|"~     The current prospective cross-sectional pilot study is proposed to determine a set of~     characteristic factors associated with salt sensitivity in young adults by measuring blood~     pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central~     arterial pressure in response to short term increases in salt intake.~   "
35805|NCT02588339|"~     This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD~     prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in~     combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host~     disease (GVHD).~   "
35806|NCT02588326|"~     Currently FDA does not accept pharmacokinetic studies to show bioequivalence of~     locally-acting nasal suspension formulations.~      However, bioequivalence is defined as the absence of significant differences in~     pharmacokinetics of therapeutically equivalent drug products compared to the matching~     originally invented drug formulation. These there-called generic drugs are then~     interchangeable. Drug companies have to show that their generic version has the same active~     ingredient, the same label, is intended to be used for the same conditions or diseases and~     works at the same rate in the body.~      The aim of the study is to determine if pharmacokinetics is sensitive to differences in the~     particle size distribution of three different nasal suspension formulations of mometasone~     furoate during charcoal block. The result from this study will aid the FDA in finding~     methods to ensure that generic products are the same as the trade name drugs.~   "
35807|NCT02588313|"~     Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit~     powder on microcirculation and endothelial function after supplementation of 4 weeks.~     Effects will be investigated with 100mg and 300mg CarelessTM and compared to placebo.~   "
35808|NCT02588300|"~     This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE).~     The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep~     apnea hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.~      This study correlates the sedation level measured by entropy during DISE using propofol via~     a TCI pump with the local obstruction patterns of the upper airway according to the VOTE~     classification.~      As OSAHS is a widespread disease and the DISE procedure has become a common tool for~     diagnosis and evaluation of further treatment, a growing number of research articles deal~     with this topic. These articles are available through pubmed.~   "
35809|NCT02588287|"~     This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the~     pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based~     antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV~     PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to~     participate. The study consists of three visits: a screening visit and two abbreviated~     4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4~     weeks after initiating SOF/LDV).~   "
35810|NCT02588274|"~     Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide.~     So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators~     design and implement this study is to assess efficacy of acupuncture therapy performed in~     the CP/CPPS .~   "
35811|NCT02588261|"~     The purpose of the study is to evaluate the progression free survival (PFS), based on~     independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in~     patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma~     non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating~     mutations.~      This study will also assess Overall survival (OS); Overall response rate (ORR) as assessed~     by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR;~     Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and~     patient-reported outcome (PRO) parameters.~   "
35812|NCT02588248|"~     The primary objective of this double-blinded, prospective, randomized placebo-controlled~     study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of~     peppermint oil solution vs placebo application during colonoscopy. The investigators~     hypothesize that ADR will be increased with the use of the peppermint oil solution and thus~     further reduce the risk of colon cancer by means of colonoscopy.~   "
35813|NCT02588235|"~     After successful coronary angiography and OCT examination, patients with TCFAs in~     non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly~     assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20~     mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be~     scheduled for the target vessel after 12 months.~   "
35814|NCT02588222|"~     The purpose of this study is to establish reliable reference intervals for fecal S100A12 in~     healthy children.~   "
35816|NCT02588196|"~     The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene~     A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese~     patients.~   "
35817|NCT02588183|"~     The COR advance study is a non-randomized prospective single center study to assess the~     results of an electrophysiologically guided approach for PV cryoablation using the Arctic~     Front Advance ST® catheter together with the Achieve® mapping catheter in 25 patients with~     drug-refractory paroxysmal AF.~      Methods Patient selection criteria will be the same that in the original COR study. All~     patients will be followed with a Reveal LINQ® cardiac monitor that will be implanted before~     ablation. The primary objective is the proportion of patients remaining free from atrial~     fibrillation recurrences without taking antiarrhythmic drugs 12 months after ablation.~     Secondary objectives are: AF-free survival without anti arrhythmic drugs 12 months after~     ablation, cumulative AF burden (number of AF episodes and percentage of time in AF) 12~     months after ablation, percentage of the pulmonary veins with bidirectional block at the end~     of the procedure, and ablation time (from the onset of the first energy delivery to the end~     of the last energy delivery), procedure time (from femoral puncture to catheter removal),~     and fluoroscopy time.~      Final results will be known 24 months after the first enrollment. Statistical analysis~     Continuous variables that are distributed normally according to the Shapiro-Wilk test will~     be presented as the mean [standard deviation], and the values will be compared with the t~     test. Continuous variables that do not follow a normal distribution will be presented as the~     median [25th to 75th percentile] and will be compared with the Mann-Whitney U test.~     Categorical variables between two groups with expected values <5 will be compared with the~     Fisher exact test. Otherwise, categorical variables will be compared with the chi-squared~     test. The AF-free survival functions will be represented as Kaplan-Meier curves. Data~     analyses will be done with JMP® (version 9.0.1, SAS Institute Inc., Cary, NC, USA) and~     Stata® (version 11.0, StataCorp LP; College Station, TX, USA).~   "
35818|NCT02588170|"~     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the~     efficacy of Sulfatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine~     tumors.~   "
35819|NCT02588157|"~     Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the~     intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.~   "
35820|NCT02588144|"~     54 patients with idiopathic Parkinson's disease and freezing of gait resistant to~     subthalamic nucleus stimulation and dopaminergic medication will be included into this~     multicentre randomised controlled double-blinded parallel group clinical trial. The~     treatment consists of two different stimulation settings using (i) conventional stimulation~     of the subthalamic nucleus [standard STN] as active comparator and (ii) combined stimulation~     of active electrode contacts located in both the subthalamic nucleus and substantia nigra~     pars reticulata [STN+SNr].~   "
35821|NCT02588131|"~     This phase 2, open-label, single arm study aims to evaluate the efficacy of tremelimumab in~     combination with the anti-PD-L1 MEDI4736 in patients with unresectable malignant~     mesothelioma subjects~   "
35822|NCT02588118|"~     In recent years it has become clear that gender differences exist both in the~     pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia.~     Differences in pharmacokinetics are more straightforward to study than differences in~     clinical effects. However, isolated pharmacokinetic data are of less value if they are not~     accompanied by measurements of clinical effects. Males are more sensitive than females to~     propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males.~     Females have 20-30% greater sensitivity to the muscle relaxant effects.~   "
35823|NCT02588105|"~     The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to~     give, and how it is processed by the body when given alone or in combination with other~     agents. The study will also collect some initial information about how effective it is.~   "
35824|NCT02588092|"~     This study evaluates ADCT-301 in patients with Acute Myeloid Leukemia (AML) or Acute~     Lymphoblastic Leukemia (ALL). Patients will participate in a dose-escalation phase (Part 1)~     and receive ADCT-301 every 3 weeks.~      In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks.~   "
35825|NCT02588079|"~     The purpose of this study is to determine whether internet-based cognitive behavioral~     therapy (ICBT) is effective in the treatment of children and adolescents with dental~     anxiety. The investigators hypothesis is that children and adolescents who have been offered~     ICBT show significant better performance on outcome measures compared with patients in~     control group.~   "
35826|NCT02588066|"~     To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the~     ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum~     that do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding~     during surgery.~      Thus a surgical technique is evaluated prospectively.~   "
35827|NCT02588053|"~     Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing~     the progression of whole brain atrophy. Whole brain atrophy rates will be measured through~     magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis~     (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy~     controls. The primary outcome will be whole brain atrophy rate measured as the percent~     change in brain volume (PBVC) over a two-year period.~      Primary hypothesis:~      The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of~     whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change~     in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a~     true disease activity free state).~   "
35828|NCT02588040|"~     The objective of the study is to further characterize the performance of L-PRP prepared~     using the Biomet Recover Kit in the treatment of chronic LE. The study will explore the~     potential impact of patient demographics and baseline characteristics on treatment outcome.~     Furthermore it will track and document treatment effects, time course, and untoward effects~     following treatment of chronic LE with L-PRP from the Recover device. In addition, the~     utilization of healthcare resources and associated costs will be investigated in treated~     patients.~   "
35829|NCT02588027|"~     This will be a randomized controlled trial to determine if postoperative ibuprofen after~     arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog~     Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.~   "
35841|NCT02587871|"~     This phase II trial studies how well donor cellular therapy after cytarabine works in~     treating patients with intermediate-risk acute myeloid leukemia with a decrease in or~     disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term~     transfusion of cells from a family member who is incompletely matched. The use of these~     partially matched white blood cells may help improve response to standard chemotherapy~     (cytarabine) and reduce some of the risks of infection, without a permanent transplant.~     Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving donor cellular therapy after cytarabine may kill more cancer~     cells.~   "
35830|NCT02588014|"~     The purpose of this project is to examine potential mechanisms that may underlie early~     visual and auditory perception as well as visual and auditory affect perception deficits in~     schizophrenia and the possible connection between these processes. Given that affect~     perception largely involves visual and/or auditory information processing and likely relies~     on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine~     affect perception deficits within the framework of the more basic visual and auditory~     processes. Specifically, the investigators will examine magnetophysiological correlates of~     vocal and visual affect discrimination, non-affective face discrimination and voice~     discrimination, and simple visual and auditory stimulus discrimination, using~     Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits,~     as well as their contribution to affect perception deficits in schizophrenia.~   "
35831|NCT02588001|"~     The purpose of this study is to investigate the efficacy and safety of enzalutamide in~     patients with non-metastatic castration resistant prostate cancer. The total duration of the~     study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules)~     orally once daily. The treatment will be started at Visit 0 within one week after~     enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are~     conducted on adverse events and the Japanese version of the Functional Assessment of Cancer~     Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the~     investigator can continue the treatment with 12-week cycle visit (counted from initial dose)~     until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after~     enrollment and at 3 years after the last participant enrollment. The end of the study is~     defined as follow-up assessment date at 3 years after the last participant enrollment.~     Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free~     survival (PFS).~   "
35832|NCT02587988|"~     Trial to Evaluate the Efficacy and Safety of HCP1302~   "
35833|NCT02587975|"~     This study is designed to measure the effect of evogliptin on bone metabolism in healthy~     volunteers.~   "
35834|NCT02587962|"~     An ascending dose study in patients with solid tumors to evaluate the safety, tolerability,~     pharmacodynamics and efficacy of birinapant when given in combination with pembrolizumab.~   "
35835|NCT02587949|"~     In patients admitted to hospital with acute cerebrovascular stroke, we want to study the~     relationship between hair cortisol levels and biomarkers of inflammation and the clinical~     and radiological severity of the stroke and the degree of neurological disability being~     tested in three months and one year after.~   "
35836|NCT02587936|"~     ICD-Pieces (Parkland Intellegent e-Coordination and Evaluation System) trial is a National~     Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to~     improve management of patients with a triad of CKD, hypertension and diabetes with Pieces in~     four HCS including Parkland, Texas Health Resources (THR), ProHealth and North Texas VA.~     Pieces is a decision support technology platform created by Parkland Center for Clinical~     Innovation(PCCI).~      The primary objective is to test the hypothesis that a collaborative model of primary care~     and subspecialty care intervention enhanced by Pieces and practice facilitators compared to~     standard clinical practice will reduce all-cause hospitalizations in patients with~     coexisting CKD, diabetes and hypertension.~      Secondary objectives are: a)Test if implementation of the collaborative model will reduce~     30-day readmissions, emergency room visits, cardiovascular events or deaths and~     disease-specific hospitalizations; b) Develop and validate risk predictive models for~     disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions,~     emergency room visits, cardiovascular events and deaths for patients with CKD, diabetes and~     hypertension. c) Collect demographic and clinical data to assist phenotyping patients with~     CKD, diabetes and hypertension. d) Obtain safety data including AKI, progression of CKD,~     electrolyte disturbances and medication errors, and drug toxicity; e) Collect resource~     utilization information including hospitalizations, emergency room visits, outpatient~     visits, and diagnostic or therapeutic procedures completed.~      Candidate patients in selected clinics will be enrolled over a period of 2 years and~     followed for 12 months. Pieces will ascertain both primary and secondary outcomes from the~     EHR supported with data from the DFWHC, Accountable Care Organization (ACO) reports and VA~     database, and deaths from Social Security Index (SSI) data.~   "
35837|NCT02587923|"~     Background: Accurate diagnosis of small gastric subepithelial tumors (SETs) is essential in~     order to assess their malignant potential. Endoscopic unroofing by conventional snare or~     needle knife has been reported to yield sufficient tissue samples for histological~     evaluation including immunohistochemical staining.~      Aims: The investigators aim to evaluate endoscopic unroofing in patients with small gastric~     SETs regarding its safety and diagnostic accuracy as well as a potential therapeutic effect~     of this technique over time.~      Methods: In the context of a retrospective analysis, the investigators will identify~     patients who underwent endoscopic unroofing of small SETs of the stomach at the Medical~     University of Vienna. Demographic data, indication for intervention, safety of the procedure~     and follow‐up will be assessed.~   "
35838|NCT02587910|"~     Melanole, a Nigella sativa (Black Seed) extract , is studied for the treatment of GERD.~     Participants, who meet the inclusion criteria, will be divided into two arms.~      Arm 1: Subjects who meet criteria for GERD will undergo 24 hour pH monitoring.~      Arm 2: Subjects who meet criteria for GERD and who undergo only symptomatic monitoring of~     GERD on treatment.~      All participants will be evaluated before and after the administration of the study product.~   "
35839|NCT02587897|"~     Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal~     disorder, impacting 10 million people annually and costing employers up to $113,695 per~     incident. There is currently no established method to detect this disorder prior to the~     onset of symptoms and nerve damage. Preliminary research suggests that sonography—a~     relatively inexpensive, widely available, increasingly portable technology—can provide a~     non-invasive and pain-free method of early detection that could reduce incidence, improve~     targeted interventions and ultimately reduce costs. The primary aims of this study are to~     establish predictive validity of a novel method for early detection using sonographic~     imaging and to identify task components of intensive functional hand activity associated~     with morphologic changes.~   "
35840|NCT02587884|"~     The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on~     the prognosis of patients with microvascular invasion presence(MVI) and overexpression of~     Aspartate-β-hydroxylase(ASPH).~   "
35842|NCT02587858|"~     The purpose of this study is to learn more about a subtype of Neurodegeneration with Brain~     Iron Accumulation (NBIA) called Pantothenate Kinase-Associated Neurodegeneration (PKAN) by~     (1) collecting information about how symptoms and findings in NBIA change over time and (2)~     identifying measures of NBIA that can be used in future clinical trials. Participants will~     logon to a secure website from home every 6 months for a period of 5 years to electronically~     complete a set of rating scales as related to their NBIA.~   "
35843|NCT02587845|"~     Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients~     undergoing total hip arthroplasty. However, no to date, no study has been large enough to~     determine definitively whether the drug is safe and effective. The present study was~     designed to verify noninferior efficacy and safety of topical intra-articular TXA compared~     with intravenous TXA in primary THA.~   "
35844|NCT02587832|"~     To compare the primary outcome, failure of extubation defined by the need for re-intubation~     and mechanical ventilation within 5 days of initial extubation and secondary outcomes,~     morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC)~     and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation~     period for preterm infants between 24 and 28 weeks gestation with respiratory distress~     syndrome.~   "
35845|NCT02587819|"~     This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and~     tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.~   "
35846|NCT02587806|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI).~   "
35847|NCT02587793|"~     The aim of this project is to investigate whether the proliferative speeds of cultured cells~     using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging~     classification for the possibility of personalized treatment and prediction the outcomes in~     hepatocellular carcinoma (HCC) patients.~   "
35848|NCT02587780|"~     This observational study is designed to examine the glycaemic responses (of sedentary,~     active and very active healthy individuals) to a 50gram dose of glucose.~   "
35849|NCT02587767|"~     The purpose of this study is to determine whether micropulse laser (MPL) is different to~     half-dose photodynamic therapy on acute central serous chorioretinopathy.~   "
35850|NCT02587754|"~     This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants~     with Parkinson's Disease. Half of participants will receive real acupuncture while the half~     will receive placebo acupuncture.~   "
35851|NCT02587741|"~     Diabetic retinopathy (DR) is an important cause of blindness.~   "
35852|NCT02587728|"~     Carpal tunnel is an early manifestation of amyloidosis in a significant minority of~     patients. This specimen collection protocol will allow the investigators to screen patients~     with carpal tunnel syndrome for amyloidosis.~   "
35853|NCT02587715|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI)~   "
35854|NCT02587702|"~     The purpose of this study is to determine whether different content of β-palmitate will~     cause significant differences on Fatty Acids and Mineral Metabolism in Infants~   "
35855|NCT02587689|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric~     antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for~     patients with relapsed or refractory solid tumor.~   "
35856|NCT02587676|"~     Thirty complete maxillary denture wearers were recruited after obtaining informed consent.~     One investigator measured the Shore D hardness of the commercially available RDLs using a~     Vesmeter®. The salivary flow rates and pH values and the occlusal force were measured for~     all patients before initiation of the study.~      T-tests and Pearson's correlation coefficients were used for statistical analyses.~      A p-value of <0.05 was considered statistically significant.~   "
35857|NCT02587663|"~     This clinical trial studies mammography and targeted ultrasound with or without whole-breast~     ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent~     of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic~     imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find~     out how far breast cancer has spread. It is not yet known whether mammography and targeted~     ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced~     MRI in finding out how far breast cancer has spread.~   "
35858|NCT02587650|"~     This is a phase II multi-center prospective basket trial designed to test the hypothesis~     that targeting specific kinase fusions in metastatic melanoma with pre-specified kinase~     inhibitors will result in objective tumor shrinkage and durable response. The study design~     is a 2 stage optimal design with a sample size of N=35, with n1=11 during stage I and n2=24~     during stage II. If 1 or fewer responses are observed during stage I, the trial will be~     stopped. If 6 or fewer responses are observed by the end of stage II, the trial will be~     stopped.~   "
35859|NCT02587637|"~     The purpose of this prospective post market observational pilot study is to evaluate the~     effect of DRG stimulation in the management of chronic discogenic pain in subjects who are~     refractory to other available treatments. Selected subjects will not be suitable candidates~     for lumbar spinal surgery and will meet the standard selection process for DRG stimulation~     as routinely utilised in the study centre. Results from this pilot study will inform current~     clinical practice and future comparative studies in this specific population.~   "
35860|NCT02587624|"~     Prospective observational single center trial, evaluating the safety, radiation exposure and~     efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.~   "
35861|NCT02587611|"~     The purpose of this study is to compare the effect of either elemental liquid diet or~     standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients~     receiving gastrostomy feeding.~   "
35862|NCT02587598|"~     This is an open-label, dose-escalation study of the PIM kinase inhibitor INCB053914 in~     subjects with advanced malignancies. The study will be conducted in 2 parts. Part 1 (dose~     escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 and~     the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be~     taken forward into Part 2 of the study). Part 2 (dose expansion) will further evaluate the~     safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase~     2 dose(s).~   "
35863|NCT02587585|"~     The amount of activity completed by individuals within rehabilitation programs, even when~     units are well staffed, is often far below that required for optimal stroke rehabilitation,~     and is not individually adapted on a day-to-day basis. Daily feedback on their activity~     levels may motivate stroke survivors to engage in greater skills practice and thus outcome~     after stroke. To date only a few trials suggests that augmented feedback may be effective.~     There is a need for a large pragmatic trial to explore the impact of augmented activity~     feedback on top of their standard care. The purpose of this study is to determine the effect~     of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.~   "
35864|NCT02587572|"~     This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the~     safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic~     syndrome and to assess the effects of LMSCs on endothelial function using several different~     doses.~   "
35865|NCT02587559|"~     Approximately 60 subjects from a sample of convenience diagnosed with shoulder arthritis~     will be randomized into a two groups. The control group will receive usual medical advice~     and the experimental group will be referred to physical therapy for eight visits over 4-week~     period of time. At one month, two months, and one year the pain, function, and patient~     satisfaction will be compared between the two groups.~   "
35866|NCT02587546|"~     The purpose of the study is to compare results of the treatment of tumorous and non-tumorous~     laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the~     past.~   "
35867|NCT02587533|"~     Peripheral chemoreceptors and baroreceptors are located in close proximity in the carotid~     artery wall at the level of the carotid bifurcation. Baroreceptor stimulation lowers~     sympathetic activity and blood pressure. In contrast, chemoreceptor stimulation raises~     sympathetic activity and blood pressure. Thus, beneficial effects of electrical carotid~     sinus stimulation on blood pressure could be diminished by chemoreceptor overactivity and/or~     concomitant chemoreceptor activation through the device. Therefore, our study will assess~     baroreflex/chemoreflex interactions in patients with resistant hypertension equipped with~     carotid sinus stimulators. The study will inform us of potential additional~     anti-hypertensive benefits of simultaneous chemoreceptor denervation during electrode~     placement. Furthermore, the results may provide information about suitable electrode design~     to spare co-activation of peripheral chemoreceptors. Taken together, the study will help~     develop strategies for improving responder rate and efficacy of carotid sinus stimulators in~     patients with resistant hypertension.~   "
35868|NCT02587520|"~     This is a dose and formulation ranging study to assess the safety and immunogenicity of~     SP0173 in healthy adolescents, adults, and older adults in the US.~      Primary Objective~        -  To describe the safety profile of each SP0173 investigational formulation.~      Observational Objective:~        -  To describe the immunogenicity of each SP0173 investigational formulation.~   "
35869|NCT02587507|"~     A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in~     peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange~     juice, when consumed together with the high-fat meal, is able to revert the increase in~     inflammatory markers. The present study will assess the effect of a single HFHC meal taken~     with water, orange juice or an isocaloric glucose drink on protein expression in peripheral~     blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals~     consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design~     with at least one week interval between the meals. Blood samples were collected before, 1, 3~     and 5h after the meals.~   "
35870|NCT02587494|"~     This is a pilot study that will lead to a large randomized control trial (RCT), to assess~     whether early versus late or no cardiac catheterization is associated with improved outcomes~     in out-of-hospital cardiac arrest (OHCA) patients.~   "
35871|NCT02587481|"~     In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be~     characterized by pneumological examination concerning a concomitant chronic obstructive~     pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit~     either from prevention or potential therapy of chronic hypoxia.~   "
35872|NCT02587468|"~     GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific~     vitamins from encapsulated Juice Plus+® powder~      ENDPOINTS~        -  Absorption kinetics of phenolic compounds in plasma~        -  Bioavailability of vitamins C, E, and carotenoids into plasma~      Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see~     underneath).~   "
35873|NCT02587455|"~     Lung cancer is the second most common cancer in the UK with around 43,500 new patients~     diagnosed each year. About 69% of patients are diagnosed with advanced stage disease and at~     present these patients would be expected to survive for less than 12 months. These~     statistics therefore show the need for the development of new effective drugs in the~     treatment of advanced Lung cancer.~      Recent trial results have shown the efficacy of immunotherapy in treating several types of~     tumours including lung cancer. These tumours are known to express a high level of a~     glycoprotein called PDL1 which is a component of the PD1 pathway. In cancer the PD1 pathway~     can be hijacked by tumours leading to the immune system being suppressed. The aim of the new~     drug Pembrolizumab is to restart the PD1 pathway and use the immune system to help fight the~     cancer cells. Radiotherapy has also been shown to cause cancer to increase production of the~     proteins that can block the immune system. Therefore it has been proposed that combine of~     new immunotherapy agent such as pembrolizumab and radiotherapy in the treatment of lung~     cancer will allow more cancer cells to be killed through the immune system.~      The purpose of this study is to see if pembrolizumab can safety be combined with standard~     palliative radiotherapy in patients with lung cancer. In addition once the patients have~     completed their course of radiotherapy they will remain on pembrolizumab alone and the study~     will look at how well this treatment regimen can control the growth of the cancer.~   "
35875|NCT02587429|"~     The aim of this study is to investigate, whether a patient education with focus on pain~     coping is able to improve physical function and experienced pain level in patients with high~     levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that~     these patients do not achieve a satisfactory pain relief and physical function after TKA.~     Furthermore, the aim is to determine if there is a difference in physical activity and~     muscle mass among patients with high levels of pain catastrophizing compared to patients~     with low levels of pain catastrophizing.~   "
35876|NCT02587416|"~     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of~     atorvastatin 80 mg~   "
35877|NCT02587403|"~     The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus~     Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral~     hernia repair and assess post-operative complication rates, long term hernia recurrence~     rates.~   "
35878|NCT02587390|"~     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of~     simvastatin 80 mg.~   "
35879|NCT02587377|"~     The availability of sensitive and specific fungal biomarkers could be a precious help to~     improve the management of patients suffering from fungal diseases, not only by allowing~     preemptive treatment, but also by offering objective elements to assess patient therapeutic~     response and prognosis.~      The use of such biomarkers could also contribute to accurately evaluate novel antifungal~     drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective~     treatments and dose selection in product development. Using two or three tests may increase~     the sensitivity to detect IFI.~      The results of the serum assays will be correlated to the definition of 'proven' fungal~     infection as defined by the EORTC/MSG criteria published in 2008. Based upon results from~     adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-D glucan~     could reasonably have a 90% sensitivity (with a 95% CI between 73% and 98%) under the~     current design. As concern the aspergillus fumigatus PCR, sensitivity and specificity could~     be estimated between 63% to 100% and 87% to 96.7%, respectively.~   "
35880|NCT02587364|"~     The purpose of this study is to evaluate the multiple‐dose pharmacokinetic characteristics~     and pharmacologic activity of gemcabene.~   "
35881|NCT02587351|"~     This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that~     will enroll 1028 patients with at least moderately severe COPD over a three year period and~     follow them at regular intervals for one year. The primary endpoint is time to first acute~     exacerbation. Secondary endpoints include rates and severity of COPD exacerbations,~     cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and~     metoprolol-related side effects.~   "
35882|NCT02587338|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with~     transcranial direct current stimulation [tDCS]) during working memory training in seniors~     with subjective memory impairments.The placebo-controlled double blinded study includes 50~     elderly probants which were randomized into verum or sham tDCS.~   "
35883|NCT02587325|"~     mTOR activation has been shown to be relevant in the development and progression of~     pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary~     hypertension in animal models. ABI-009 is an albumin-bound mTOR inhibitor with improved~     penetration in lung tissue.~   "
35884|NCT02587312|"~     The purpose of this study is to determine how reducing the level of nicotine in cigarettes~     may affect adolescent smoking behavior. In this study, the researchers will randomize~     adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine~     content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline~     period. Participants will be instructed to smoke only those cigarettes. The researchers will~     conduct daily assessments of total cigarette use (both study cigarette and non-compliant use~     of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon~     monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes~     and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and~     toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect~     real-world smoking behavior in adolescents, and illuminate the potential mechanisms through~     which these products may effect such changes. Such knowledge will contribute to the science~     base that may inform future policy decisions.~   "
35885|NCT02587286|"~     The purpose of this trial is to explore the impact of the Gather Health diabetes management~     platform diabetics' health behaviors and health outcomes and how providers and diabetics~     interact with the Gather Health platform.~   "
35886|NCT02587273|"~     This study is part of a project intended to develop guidelines to optimise the dosing of~     fentanyl in intensive care patients.~      This study will focus on determining:~        -  Whether the pharmacokinetics of fentanyl change during the ICU stay.~        -  To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients.~        -  Which factors (e.g. physiological variables) that cause such a change.~        -  Based on simulations, determine context-sensitive half-times of fentanyl in ICU~          patients.~   "
35887|NCT02587260|"~     The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not~     prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with~     peripheral arterial tonometry and markers of endothelial function measurement in post-ACS~     patients.~   "
35888|NCT02587247|"~     Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific~     anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging~     potential candidate patients for surgery of local resection of one or more metastases at~     diagnosis or during relapse CCR expressing CEA.~   "
35889|NCT02587234|"~     The investigators proposed to evaluate the effectiveness of sustained peripheral nerve~     stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).~   "
35890|NCT02587221|"~     A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate~     the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine~     Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.~   "
35932|NCT02586675|"~     The purpose of this study is to find out if the investigational drug Ribociclib (LEE011),~     when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial~     effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer~     known as hormone receptor positive/HER2- breast cancer.~   "
35891|NCT02587208|"~     Outcome of circumcision with Plastibell or conventional dissection techniques in infants and~     children: A prospective randomized controlled trial~      Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and~     conventional dissection circumcision~      Methods:~      Randomized Controlled Trial Inclusion criteria: patients younger than 13 years including~     neonates who required circumcision for various indications.~      Exclusion criteria: - patients with bleeding or clotting disorders~        -  Those whose parents insisted on a particular type of surgery~        -  Children with lateral- lateral diameter of the glans over which a Plastibell device~          could not be placed Primary endpoint: parental concerns and satisfaction~          (questionnaire) Secondary endpoints: composite morbidity, operative time, postoperative~          pain (analgesic requirements)~        -  Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence,~          mean duration, emergency care if necessary, parental concerns about them (on a~          Likert-type 5-point scale [ not at all, a little, rather, very, very much])~        -  Irregular scar, jumbling of tissues at the site of frenulum (assessed by physician)~        -  Postoperative adhesions (assessed by physician)~        -  Postoperative pain and analgesic requirements (paracetamol 15 mg/kg PO Q6 hrs for 48~          hrs then PRN) number of doses and days required for analgesia as judged by parents, VAS~          ( >- 6 SCORE ), Kaplan-Meier analysis (time to event)~        -  Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied,~          rather, a little satisfied, not at all satisfied])~        -  Parental satisfaction ( skin removal): excess skin removal, insufficient skin removal [~          not at all, a little, rather, very, very much]~        -  Time for bell separation (mean +-SD), Kaplan-Meier analysis for different age groups~   "
35892|NCT02587195|"~     National, multicenter study:~      The study consists of 3 periods:~        1. A baseline visit to confirm that patient is still in CIS status. All patients will be~          clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to~          exclude MS patients according to 2010 Mc Donald's criteria.~        2. Treatment period with timed evaluations~        3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and~          accelerated elimination procedure. All patients who discontinue the study drug and~          according to investgator's decision, will perform the accelerated elimination procedure~          and the post- accelerated elimination visits (at 2 and 4 weeks after the end of~          treatment (EOT).~   "
35893|NCT02587182|"~     The objective of the present study was to assess the effectiveness of deep dry needling in~     the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion~     and disability in patients with sleep bruxism and myofascial temporomandibular disorders.~   "
35894|NCT02587169|"~     Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant~     treatment in liposarcomas and leiomyosarcomas of retroperitoneum.~      The main objective of this study is to improve relapse-free survival (RFS)and overall~     survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with~     resected sarcoma of retroperitoneum.~      Secondary objectives include the analysis of antitumoral activity through response rate~     (RECIST and tissular changes), the assessment of positive correlation between biomarkers and~     clinical results, the study of long term overall survival, and the analysis of the safety~     profile of the nilotinib-adriamycin combination.~      The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and~     therefore better response results are expected (from 20% as P0 to 40% as P1). The study~     seeks to find a positive correlation between biomarkers and clinical results in~     retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination.~      The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS).~     The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with~     resectable retroperitoneal sarcoma. The research comprises a robust translational study as~     well as histological and radiological reviews.~   "
35895|NCT02587156|"~     12 elderly (65-70 years of age) male subjects will be included and complete a double blinded~     cross-over study. They will be habituated for 21 days to either low or high protein intake~     (below 0.7 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they~     will switch to the alternate group. At the end of each habituation period, the investigators~     will measure the appearance of labelled amino acids from milk proteins.~   "
35896|NCT02587143|"~     Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of~     application. The current investigation aim is to compare the effect of ethyl chloride based~     vapocoolant spray to placebo in reducing pain associated with arterial puncture for~     gasometry determinations.~      The investigators will conduce a double-blind randomized placebo-controlled trial at~     Emergency Department.~      We will enroll patients who come to Emergency Department who need an arterial gasometry~     determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant~     sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo~     will be used before arterial puncture.) and after the puncture they will rate their pain~     using a 10 points visual analogue scale.~   "
35897|NCT02587130|"~     Pain is one of the major symptoms in palliative care units and often is very difficult to~     treat, being considered as a refractory pain.~      There are different causes of refractory pain: pain due to bed sores and ulcer bandages,~     carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain~     due to traumatological injuries, pain associated with a long-term bed confinement, etc.~      The investigators propose a prospective study to estimate the effect and the tolerance to a~     subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the~     care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care~     units.~   "
35898|NCT02587117|"~     Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous~     disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for~     the treatment of oral lichen planus. Half of participants (total number of participants was~     twenty eight) were received lycopene and the other half were received prednisolone.~   "
35899|NCT02587104|"~     A single-centered, non-randomized study with approximately 20 subjects that will be seen for~     up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness~     will be monitored throughout the study.~   "
35900|NCT02587091|"~     A cluster randomized trial was conducted across eight rural sub-counties in southwestern~     Uganda. This study was conducted to determine the impact of advertising free obstetric~     ultrasound on the attendance to antenatal care clinics.~   "
35901|NCT02587078|"~     The primary alternative hypothesis is that less time (minutes) is required, to achieve the~     initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®.~        -  H01: Minutes with Volulyte® ≥ Minutes with Jonosteril®~        -  H11: Minutes with Volulyte® < Minutes with Jonosteril®~   "
35956|NCT02586363|"~     In this clinical trial, the investigator will clarify the difference in pharmacokinetics~     between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high~     fatty meal for healthy adult volunteer.~      The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.~   "
35902|NCT02587065|"~     The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the~     satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with~     injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction~     Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study~     are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on~     participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term~     participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue;~     effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN~     beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN~     beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship~     between participants' satisfaction and adherence; Evaluate the relationship between~     participants' satisfaction and social-demographic factors (age, sex, employment working,~     level of education, etc) and clinical characteristics (annualized relapse rate [ARR],~     disability, etc.) and to evaluate the treatment safety and tolerability.~   "
35903|NCT02587052|"~     This is a retrospective analysis of two different cohorts of patients that has undergone~     renal transplantation. This is a matched pair analysis of 100 patients treated with generic~     tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will~     be obtained from patients' charts, from the Swedish National Kidney Registry and from a~     local registry at Transplantationscentrum. Patients included in the study are patients~     receiving a first single kidney transplant from a deceased or a living donor, treated with~     Prograf or Tacni and transplanted between transplanted January 2012 and August 2014. The~     1-year-outcome of patients following renal transplantation, including BPAR, serious adverse~     effects and graft survival will be analysed.~   "
35904|NCT02587039|"~     Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of~     blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the~     brain may result in a condition called delirium. Delirium is a type temporary confusion.~     There are some strategies that can help reduce cerebral ischemia during cardiac surgery~     which can help lead to a reduction in the incidence of delirium. The investigator believes~     that a strategy called remote ischemic preconditioning will help to reduce the incidence of~     delirium incidence after cardiac surgery.~      Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to~     ischemia occurs in an area of the body that is not undergoing a procedure. This brief~     exposure to ischemia is not long enough to cause any damage to the body and it has been~     demonstrated to help protect against more severe ischemic injury that may occur later during~     surgery. In this study the investigator will use remote ischemic preconditioning to see if~     it can reduce the incidence delirium after cardiac surgery.~   "
35905|NCT02587026|"~     This is a tissue collection protocol to create an annotated biorepository to support future~     basic and translational research. The study protocol and consent will request patient~     permission to allow their specimens to be stored for future use in other~     laboratory/correlative studies without requiring a separate new consent at a future date. It~     will include also a retrospective review of all patients who have been seen or treated by~     the Precision Genomics Clinic (waiver of consent requested). No specific research~     studies/aims are included directly in this proposal. Use of the samples, data, and other~     resources (cell lines, etc.) created within this protocol will require review/approval by~     the majority of the Precision Genomics Investigators and appropriate IRB approval.~   "
35906|NCT02587013|"~     This study is designed to compare the exteriorization of the uterus versus the in situ~     repair for closure of the hysterotomy incision with a completely standardized anesthetic~     protocol.~   "
35907|NCT02587000|"~     Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal~     acetate) on bleeding control and pain for patients with adenomyosis and wish to keep~     fertility.~   "
35908|NCT02586987|"~     This is a phase I, open-label, multi-centre study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of ascending doses of selumetinib in~     combination with MEDI4736 in patients with advanced solid tumour~   "
35909|NCT02586974|"~     The aim of this study is to assess if the conditioning of the insufflation carbon dioxide~     (CO2) allows for an additional benefit in terms of prevention of the heat loss, when~     compared with the usual prevention with a forced warm air blanket alone, in the setting of~     robot-assisted radical prostatectomy (RARP).~   "
35910|NCT02586961|"~     The combined administration of high dose of oral betamethasone and nebulization of~     adrenaline seems to be an attractive therapeutic alternative for reducing the rate of~     hospitalization for acute bronchiolitis treated in the emergency department. However, it is~     essential to confirm the trend previously observed with this treatment before using it in~     current practice.~   "
35911|NCT02586948|"~     Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of~     the respiratory management represents a fundamental challenge for improving prognosis and~     reducing mortality. While the hospital mortality of patients treated with NIV has decreased~     over years, and is currently less than 10 %, mortality in patients treated with invasive~     ventilation remains higher than 25%. To improve the prognosis of patients with acute~     exacerbation of COPD requiring invasive mechanical ventilation is therefore a major~     challenge in terms of morbidity and mortality. Among the means available to achieve this~     goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising~     approach.~      The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to~     limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for~     an acute exacerbation, while improving gas exchange.~   "
35912|NCT02586935|"~     This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment~     of core symptom domains in adolescents with Autism Spectrum Disorders~   "
35913|NCT02586922|"~     The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and~     pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and~     correlate the results with postnatal respiratory distress of the term neonates.~   "
35914|NCT02586909|"~     This 12-month open-label study will provide further information regarding the long-term~     safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who~     have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001~     (double-blind study).~   "
35915|NCT02586896|"~     This study will compare the effects of brief strengths-based case management (SBCM) to the~     effects of screening, assessment and referral alone (SAR) in opioid-dependent patients.~     Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150~     per group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be~     completed at 3 and 6 months, by staff who are blinded to treatment condition.~   "
35916|NCT02586883|"~     The purpose of this study is to identify the abnormalities of bronchial trans-epithelial~     transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the~     bronchi.~   "
35917|NCT02586870|"~     This is a prospective multicenter study based on the validation of diagnostic criteria and~     predictive factors of treatment efficacy for renal artery stenosis in renal artery~     dysplasia. This is considered as a rare disease and patients are usually treated in~     specialized centers involved in a national network. Marseille is a center specialized in FMD~     and a member of the network that is very active across the country. In order to rapidly~     recruit patients the investigators propose a multicenter study. All patients included will~     benefit from an invasive angiography with trans stenotic gradient assessment at rest. In~     case of bilateral stenosis the investigators will randomly omit data from one side and~     consider the data from the contralateral artery for further analysis, to avoid statistical~     interdependency. Patients who require angioplasty and who have unilateral stenosis~     (unilateral FMD lesion or bilateral but with one non significant stenosis based on duplex~     ultrasound European recommendations for atherosclerotic renal artery stenosis) will be~     included in the second part of the study. These patients will in addition benefit from a~     trans stenotic pressure assessment under vasodilation and intravascular renal artery~     ultrasound. Patients with severe bilateral renal artery stenosis will not be included in the~     analysis to assess predictive criteria for treatment efficacy on hypertension, treatment of~     these patients will followed the current best clinical practice. These patients will be~     followed during 6 to 8 month to assess potential complication of the pressure assessment~     renal artery stenosis, but their data will be included to assess the value of FFR and IVUS~     to guide the procedure. Patients with unilateral stenosis will be followed up 6 month after~     angioplasty in order to assess hypertension and to look for potential complications.~   "
35918|NCT02586857|"~     A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety of~     ACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemic~     treatment regimens.~   "
35919|NCT02586844|"~     Prospective study to obtain fresh tumor biopsies and three blood samples from patients with~     a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine~     tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for~     molecular profiling.~   "
35920|NCT02586831|"~     To assess whether there is a difference in endogenous insulin secretion, measured as~     stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance~     test), at the 1 year visit, for study subjects receiving combinational therapy versus those~     receiving placebo. The study will also examine the effect of the proposed treatments on~     immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.~   "
35921|NCT02586818|"~     This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR~     system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR~     using a laboratory reference instrument and reagent (Sysmex/Innovin) calibrated to the WHO~     rTF09 reference standard.~   "
35922|NCT02586805|"~     This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to~     evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in~     patients with Type I and Type II HAE.~   "
35923|NCT02586792|"~     The study will be an open-label phase 2 clinical trial of a single dose of an inactivated~     H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously~     participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the~     previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28~     days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in~     a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1)~     assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who~     previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To~     assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9~     approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals~     who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.~   "
35924|NCT02586779|"~     Effective communication between consulting physicians and the emergency physicians is~     critical for patients in the emergency department. The aim of this study was to determinate~     effectiveness of whatsApp usage for communication between physicians.~   "
35925|NCT02586766|"~     The purpose of this study is to determine whether a brief motivational interviewing~     intervention given during emergency department care to 14-20 year olds seeking treatment,~     could reduce youth violence.~   "
35926|NCT02586753|"~     The purpose of this study is to determine which regimen is better for esophageal squamous~     carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.~   "
35927|NCT02586740|"~     Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite~     for patients with pulmonary artery stenosis or small pulmonary arteries following surgical~     repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary~     collaterals. Considering that the investigators' institution is a major center for treating~     these cases, the investigators wanted to do a retrospective review of the investigators'~     data to share the investigators' anesthetic management of these procedures.~   "
35928|NCT02586727|"~     The primary objective of the study is to assess the safety of intravitreal aflibercept~     injection in treating visually compromising radiation maculopathy secondary to treatment of~     uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25~     patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6~     weeks. Subjects in arm 2 will undergo treatment and if improvement is documented at the~     following evaluation the next treatment will be extended by two weeks. Secondary objectives~     of the study include evaluation and analysis of visual acuity, number of injections, macular~     edema, and vascular activity between both arms.~   "
35929|NCT02586714|"~     This study examined the relationships between maternal body composition, placental function,~     and fetal nutrition and body composition, and sought to determine the most accurate method~     of maternal body composition analysis in late pregnancy.~   "
35930|NCT02586701|"~     Investigation into prehabilitation by increasing the supervision of exercise in patients~     undergoing colorectal resection for cancer and comparing with patients involved in a~     rehabilitation group receiving exercise after surgery.~   "
35931|NCT02586688|"~     To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham~     treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).~   "
35933|NCT02586662|"~     Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated~     muscular activation. The characteristics of scapular dyskinesis may be associated with~     functional disability. The investigators investigated whether the level of shoulder function~     and primary dysfunction items were different in each unique pattern of scapular dyskinesis.~     The factors associated with shoulder dysfunction in different patterns of scapular~     dyskinesis were identified.~      Methods: Participants with unilateral shoulder pain were classified as having a single~     dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern~     II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel~     Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior~     shoulder tightness, and pectoralis minor index were recorded. These clinical measurements,~     3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular~     activation (electromyography on the upper, middle, and lower parts of the trapezius and~     serratus anterior muscles) during arm elevation were analyzed for associations with~     functional disability.~   "
35934|NCT02586649|"~     Respiratory complications are the leading cause of death during the initial year after acute~     SCI, and the third leading cause of death thereafter. Complete or partial loss of~     respiratory muscle innervations in individuals with cervical and high thoracic injuries~     leads to inadequate ventilation and inability to effectively clear secretions, often~     prompting supportive ventilation following initial injury. Development of atelactasis,~     pneumonias and respiratory failure are the most common respiratory complications observed~     during the acute phase of injury. It is well known that a restrictive ventilatory defect,~     dependent upon the level and completeness of injury, is apparent in individuals with chronic~     cervical SCI. Respiratory functional impairment might be further compromised in these~     individuals, the majority of whom share many aspects of obstructive airway physiology~     commonly associated with asthma. The asthma-like features that individuals with chronic~     cervical SCI demonstrate have been hypothesized to be due to overriding cholinergic airway~     tone carried by intact vagal (parasympathetic) nerve fibers arising from the brainstem,~     whereas sympathetic innervations is interrupted at the level of the upper thoracic spinal~     cord. Whether airway narrowing and AHR in chronic cervical SCI is also related to chronic~     airway inflammation is unknown, although it is conceivable that repeated respiratory~     infections or, possibly, a neurogenic component, could contribute to chronic airway~     inflammation.~      Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium~     bromide) affects various indices of lung function, including: pulmonary function tests,~     levels of inflammation and cough strength across 24 hours after receiving study drug.~     Results will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug~     inhalation for both active medication and non-active placebo.~   "
35935|NCT02586636|"~     Metformin is the first-line treatment for medical management of Type 2 Diabetes. Up to 25%~     of patients experience significant gastrointestinal symptoms and in approximate 5%,~     side-effects result in the discontinuation of metformin. It would be of great clinical~     significance if the underlying cause of this intolerance was identified.~      Recent data has highlighted a metformin transporter in the gut - Organic Cation Transporter~     1(OCT1) - as a potential culprit for the variability in metformin tolerance. Across a~     diabetic population, up to one in four people were shown to have a single reduced function~     allele for OCT1, with approximately 8% having two reduced function alleles. This may~     increase the risk of the individual experiencing metformin-associated side-effects,~     potentially due to accumulation within the cells lining the intestine. The investigators aim~     to show that loss of function of OCT1, either due to genetic variation or drug inhibition of~     OCT1, may lead to an increase in the symptoms associated with metformin intolerance.~      The study is being undertaken at the Clinical Research Centre in Ninewells Hospital, Dundee.~     The investigators will recruit participants from the GoDARTS study (Genetics of Diabetes and~     Audit Research Tayside Study). The participants will be healthy controls, i.e. non-diabetic,~     and recruited according to their genotype of OCT1 (information from GoDARTS). The volunteers~     will then enter a matched cross-over study with two treatment periods. Metformin is taken~     during both treatment periods alongside either Omeprazole (a proton pump inhibitor used to~     prevent excess stomach acid, known to interact with OCT1) or placebo. The metformin dose is~     increased gradually during each period, to a maximum tolerated dose. The investigators~     expect to see a lower maximum tolerated dose in individuals with loss of function genotype,~     or in those taking concurrent omeprazole compared to placebo. The study will last~     approximately 9 weeks. Volunteers have 3 visits to the CRC, and weekly phone call~     interviews.~   "
35936|NCT02586623|"~     To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD),~     Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic~     Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously~     stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH)~     (dizziness, light-headedness, or feelings that they are about to black out)~   "
35937|NCT02586610|"~     This is a phase II, prospective open label multi-center study in which subjects with stage~     II-III rectal cancer will be accrued in order to determine the pathological complete~     response rate of neoadjuvant pembrolizumab in combination with chemoradiation treatment~     (CRT). Subjects must have a diagnosis of rectal cancer, stage II (T3-4, N0) or stage III~     (any T, N1-2). Subjects must have received no prior treatments (chemotherapy, pelvic~     radiation or surgery) for their rectal cancer.~      Eligible subjects will receive standard chemoradiation with pembrolizumab administered every~     3 weeks on days 1, 22, and 43 of the neoadjuvant interval. In all subjects, restaging~     endorectal or pelvic MRI with chest and abdominal CT will be performed at 6-8 weeks after~     completion of neoadjuvant treatment to determine resectability and to rule out any evidence~     of metastases. Subjects who have resectable disease will undergo surgery within 2-4 weeks of~     imaging; 8-12 weeks after completion of chemoradiation. Subjects who are found to have~     unresectable or metastatic disease post treatment with the combination of CRT+ pembrolizumab~     should receive standard of care definitive treatment per the discretion of their treating~     physician.~   "
35938|NCT02586597|"~     Stroke is the third most common cause of death in the United States after heart disease and~     cancer, and the leading cause of long-term disability. This work will develop an innovative~     brain stimulation method (paired associative stimulation) which might set the stage for a~     new treatment for stroke rehabilitation.~   "
35939|NCT02586584|"~     The purpose of this Canada-France study is to develop and validate a multidimensional~     patient-reported measure of perceived barriers to antiretroviral therapy adherence for~     HIV-positive patients undergoing treatment that will be theoretically founded, easy to use~     and helpful to clinicians in their medical decision-making, in a clinical or research~     setting.~   "
35957|NCT02586350|"~     To compare the effects and safety of Anlotinib with placebo in patients with Medullary~     Thyroid Carcinoma.~   "
35958|NCT02586337|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with Differentiated Thyroid Cancer.~   "
35959|NCT02586324|"~     In this research, the two media used are Global medium and SSM medium with serum), which are~     routinely used in the reproduction biology unit. This study simply consists in setting up a~     methodology to compare these to media. The only constraint placed on patients is to accept~     randomization for the type of medium used.~   "
35960|NCT02586311|"~     Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in~     Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy~   "
35940|NCT02586571|"~     The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding~     among infants who are exclusively and partially breastfed at 6 months of age in terms of~     characteristics that are hypothesised to contribute to growth and development of body~     composition in infancy.~      The scientific originality lies in the simultaneous sampling of multiple factors that are~     believed to contribute to growth and development of body composition in infancy, i.e. energy~     content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament~     and appetite. The selection of two predefined study groups, i.e. infants exclusively~     breastfed until 6 months of age and infants given complementary foods in addition to~     breast-milk from 3-4 months of age, gives the opportunity to describe, and perhaps up to~     some point compare, what now is described by the World Health Organization and in official~     Icelandic infant recommendations as optimal feeding and what studies have suggested is~     common feeding in many countries. The methods are carefully chosen, i.e. appropriate and~     non-invasive isotopes and validated questionnaires are used. To our knowledge, no study has~     reported breast-milk composition in exclusively vs. partially breastfed infants.~   "
35941|NCT02586558|"~     Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of~     age or younger. To date, there are no known treatments that have been found to help reduce~     colic and its symptoms in babies. The investigators would like to see whether a baby formula~     that contains a prebiotic will lead to the same improvements in babies with colic. The~     investigators will test this by giving some babies a formula with the prebiotic and other~     babies a placebo formula.~   "
35942|NCT02586545|"~     The aim of the study is to test the effect of a new shared care model for type 2 diabetes~     care and compare it with a standardized care management program in a specialized~     hospital-based out-patient clinic.~      The hypothesis is that participants with type 2 diabetes followed in a shared care program~     will have a comparable outcome in HbA1c to participants receiving standard care.~   "
35943|NCT02586532|"~     Background:~      Epstein-Barr virus (EBV) can cause the cancer nasopharyngeal carcinoma (NPC). Early~     detection of NPC through screening can lead to better treatment outcomes than when it is~     found later. Currently, NPC is found through visual inspection with an endoscope. It is not~     clear how well this method works, especially for the identification of small, early cancers.~     Researchers want to see how well nasal endoscopy works to detect NPC compared to another~     method called magnetic resonance imaging (MRI).~      Objectives:~      To evaluate the sensitivity of endoscopy to detect prevalent NPC among people who screen~     positive for EBV antibodies.~      Eligibility:~      Participants of the NPC Early Detection Screening Program in China who:~      Have increased levels of EBV antibodies~      Are otherwise in good health and able to have an MRI procedure~      Design:~      Participants will be screened with a blood test.~      Participants will have a nasal endoscopy.~      Participants will have an MRI of the head and neck:~      Participants will have lesions identified by either the endoscopy or MRI biopsied and sent~     to a pathologist for review and diagnosis of NPC.~      Researchers will compare NPC detection rates by endoscopy and by MRI to see which method is~     better able to identify prevalent NPC.~   "
35944|NCT02586519|"~     Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients~     with diabetes. While most of these ulcers can be treated successfully on an outpatient~     basis, some will persist and become infected. Nearly one fifth of patients with~     lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in~     staggering costs for both the patient and the healthcare system. Therapies that promote~     rapid and complete healing and reduce the need for expensive surgical procedures impact~     these costs substantially.~      The standard of care for the treatment of diabetic foot ulcers is the removable cast walker~     (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as~     having compliance issues due to its removable nature. In addressing this limitation, a~     modified version of the RCW has been developed by wrapping it in a layer of cohesive or~     plaster bandage. This technique has been termed the instant total contact cast (iTCC)~     derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While~     ease of application and potential clinical equivalence are clear benefits, the iTCC carries~     disadvantages on account of its irremovability. For example, frequent dressing changes~     impractical, yet may be necessary for complex wound care. The goal of this research is to~     continue inquiry and innovation in this most basic aspect of care, whilst addressing the~     limitations of past research and failures in this domain.~      The investigators propose examining the capability of the SurroSense RxTM smart insole and~     smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring~     adherence to plantar pressure offloading through alert-based feedback. The insoles are~     embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides~     feedback on modifying activity or pressure profile over time. This smartwatch transmits~     audio, visual, and tactile notifications when excessive pressure-time thresholds under~     plantar regions of interest have been met. This feedback allows patients to be educated on~     their plantar pressure, and engages them and their caregivers to manage adherence to~     offloading. The investigators also propose comparing the healing rates of active neuropathic~     ulcers using RCWs coupled with the SurroSense RxTM smart insole system to assess whether~     adjunctive use of the two interventions improves the efficiency of neuropathic ulcer~     treatment.~   "
35945|NCT02586506|"~     Asthma is a chronic disease of the lungs characterized by airway inflammation,~     bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS),~     alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are~     considered a mainstay of treatment for treatment. For inhaled medications, the choice of~     inhalation device is an important consideration because an inadequate technique reduces the~     delivery of medicines and effects of inhalation. Therefore, the development of an~     easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This~     study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma~     and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined~     to be using the inhaler correctly. Study will be divided into two visits i.e.~     Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of~     Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of~     two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study,~     only subjects who are have never used the ELLIPTA inhaler before and have an established~     diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of~     the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study.~     Approximately 252 subjects will be screened with an expectation of 208 subjects completing~     the study while demonstrating correct ELLIPTA inhaler use at visit 2.~      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.~   "
35978|NCT02586077|"~     The purpose of this study is to review the use of surgeon applied liposomal release~     anesthetic (Exparel) for post operative analgesia.~      Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post~     operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by~     the use of this modality.~   "
35946|NCT02586493|"~     Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease~     characterized by airflow limitation that is not fully reversible. The mainstay for treatment~     involves the use of inhaled medications, including short and/or long-acting bronchodilators~     along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device~     is an important consideration because an inadequate technique reduces the effects of~     inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to~     the lungs effectively, is important. This study will assess the correct use of the ELLIPTA~     inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by~     those subjects determined to be using the inhaler correctly. Study will be divided into two~     visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day~     8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to~     receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label,~     placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an~     established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct~     use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this~     study. Approximately 252 subjects will be screened with an expectation of 208 subjects~     completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.~      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.~   "
35947|NCT02586480|"~     Observational study on long PR interval using the SafeR mode in bradycardia patients.~   "
35948|NCT02586467|"~     Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the~     recommended number of milk and milk product servings (≤2 servings per day). Given the wide~     range of health benefits associated with increased dietary intake of milk and milk products~     the objectives of this study were to conduct a prospective, 5-arm randomised controlled~     trial in order to test the effectiveness of a variety of messages for increasing milk and~     milk product consumption in men and women aged 30-50 years old. The five arms consisted of 4~     messages that contained slightly different content specifically: 1) gain-framed message~     condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message~     condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5)~     loss-framed plus self-regulatory efficacy-enhancing message condition. It was hypothesised~     that those who receive self-regulatory efficacy-enhancing information would consume more~     dairy than those who received messages without such information. Second, those who received~     gain-framed messages would consume more dairy as compared to those who received loss-framed~     messages. Third, those who received gain-framed messages that include self-regulatory~     efficacy-enhancing information would consume the most dairy in comparison to the other four~     conditions.~   "
35949|NCT02586454|"~     Patients who have undergone laparotomies often require multimodal postoperative pain~     regimes. In recent years, abdominal wall blocks have been included to become part of this in~     order to overcome side effects of systemic opioids and complications from epidural~     analgesia.~      Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular~     quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against~     somatic and visceral pain as local anaesthetic tends to spread from the site of injection to~     thoracic paravertebral spaces where the sympathetic chain lies.~      The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block~     in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid~     consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is~     patients given transmuscular QL block will have lower cumulative opioid consumption.~   "
35950|NCT02586441|"~     The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in~     monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic~     agents may be associated with a reduction in primary anesthetic use and a reduction in~     emergence and recovery time.~      However, this equipment does not give the proper anesthetic depth index is a number of~     experimental results have been reported.~      Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG)~     obtained through the depth of anesthesia monitors brain waves to collect statistical data,~     through mathematical analysis to analyze the exact correlation between the patient's brain~     waves and the depth of anesthesia.~   "
35951|NCT02586428|"~     Before and after a patient receives genetic counseling they will be offered the chance to~     complete the survey, by their counselor. Since each patient sees only one genetic counselor~     that counselor will be responsible for consenting and giving and collecting the finish~     surveys. No identifiers will be used. The investigators will emphasize that their answers~     will remain anonymous throughout the entire process, and that their participation is~     strictly voluntary. The patient will be provided with a survey and asked to complete this~     before their genetic counseling session and after.The survey will be returned to the genetic~     counselor and placed in a locked drawer. Information will also be collected from the medical~     record including age, pregnancy history and the reason for the visit.~   "
35952|NCT02586415|"~     This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus~     medical management leads to superior clinical outcomes in acute ischemic stroke patients at~     90 days when compared to medical management alone in appropriately selected subjects with~     the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized~     and have endovascular treatment initiated between 6-16 hours after last seen well.~   "
35953|NCT02586402|"~     The purpose of this study is to evaluate the safety and efficacy of multiple intravenous~     doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on~     dialysis.~   "
35954|NCT02586389|"~     This specimen collection is designed to obtain whole blood and tumor tissue from subjects~     diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy~     assay using next generation sequencing (NGS).~   "
35955|NCT02586376|"~     The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More~     recently the LLLT was associated with an improvement in the muscle strength and endurance.~     But, these effects were described only in health or athletic individuals. In this randomized~     and controlled clinical trails, the investigators will study the effects of LLLT on muscle~     strength of the patients with kidneys failure on long time hemodialysis treatment.~     Additionally, investigators will explore three different intensities up the muscle strength.~   "
35961|NCT02586298|"~     The principle objective is to improve embryo quality through autologous micro-injection of~     mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a~     complementary ICSI technique in patients with low embryo quality in previous IVF cycles and~     in those who did not bear children.~      This improvement in embryo quality will be determined through on-going pregnancy rate after~     treatment and/or improvement in embryo quality according to morphological~     (ASEBIR-Association for the study of Biology in Reproductive Science), morphokinetic~     criteria and in Preimplantation Genetic Screening.~      Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized~     in the first part of the study to two treatment groups; standard ICSI procedure without~     mitochondrial supplementation and ICSI with autologous mitochondrial supplementation.~     Following an interim analysis of outcomes, an additional 130 patients may be added, for a~     total of 190 patients.~   "
35962|NCT02586285|"~     The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after~     curative resection of Hepatocellular Carcinoma.~   "
35963|NCT02586272|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
35964|NCT02586259|"~     The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in~     routine clinical practice and its effectiveness and tolerability in a real-life setting.~   "
35965|NCT02586246|"~     The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection~     administered for 24 weeks or longer in subjects who are participating in the long-term~     treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly~     with or without Methotrexate.~   "
35966|NCT02586233|"~     This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded,~     Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center~     study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)~     of DS-1040b in subjects with Acute Ischemic Stroke (AIS).~   "
35967|NCT02586220|"~     Recent studies have found, in both developed and developing countries, there is still a~     considerable number of pregnant women in iodine deficiency status.Our overall aim is to~     monitor iodine status of pregnant women in China, and to examine the correlation between~     maternal urine iodine concentration (UIC) and newborn physical development level.~   "
35968|NCT02586207|"~     This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in~     combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients~     with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39~     patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy~     of this novel combination. Subjects will not be randomized and will all receive the study~     treatment.~      Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to~     initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation~     at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on~     approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant~     fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141.~     Subjects will be evaluated for response following treatment.~   "
35969|NCT02586194|"~     The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in~     patients with impaired hepatic function and subjects with normal hepatic function.~   "
35970|NCT02586181|"~     The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D~     and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.~   "
35971|NCT02586168|"~     The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as~     defined by average glucose disposal rate.~   "
35972|NCT02586155|"~     The purpose of this study is to determine whether bromodomain extraterminal domain (BET)~     inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with~     coronary artery disease increases the time to major adverse cardiovascular events.~   "
35973|NCT02586142|"~     Claw toes deformity result in spasticity often seem in patients with central nerve disease.~     It also cause pressure sore in foot and pain during walking that didn't well improve under~     traditional treatment. There are few relative reports about the Botulinum toxin type A~     (BTX-A) injection on claw toe. The investigators' study has two main purposes:~        1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving~          lower extremities function, pain and spasticity in patients with symptomatic claw toes.~        2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on~          improving lower extremities function, pain and spasticity.~   "
35974|NCT02586129|"~     Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the~     safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.~   "
35975|NCT02586116|"~     This is a post-market, prospective, randomized clinical investigation to evaluate the~     performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone~     Void Filler for the treatment of cervical disc disease. A secondary objective is to compare~     the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with~     the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40~     patients at one (1) site. After subjects have signed an informed consent, they will be~     randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF~     Device. Patients will complete the preoperative visit and examinations. Patients will be~     evaluated at discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12)~     months. Patients will be evaluated at twenty-four (24) months post-operatively if they have~     not demonstrated fusion at the 12 month time point.~   "
35976|NCT02586103|"~     The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and gold~     standard assessment tool to measure pediatric anxiety in the perioperative period.~     Therefore the objective of the current prospective study is examine if the mY-PAS is an~     effective screening tool to differentiate patients who would succeed versus fail for MRI~     without sedation/anesthesia.~   "
35977|NCT02586090|"~     The study will pilot a randomized control trial to investigate the feasibility and~     preliminary efficacy of two distinct parent treatments on a dietary intervention for~     overweight and obese adolescents.~   "
35991|NCT02585908|"~     In this study, safety and effects of γδT cells on human gastric cancer are going to be~     investigated.~   "
35979|NCT02586064|"~     Interpersonal problems such as relationship conflict and social isolation are common among~     Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main~     interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing~     Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and~     many Veterans do not complete these treatments. Couple and family approaches for PTSD~     address relationship problems, but logistical problems make it difficult for couples to~     attend sessions and these approaches do not involve Veterans who are socially isolated or~     unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD~     may be effective in reducing symptoms and improving interpersonal functioning. This study, a~     randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could~     be a useful addition to current treatments delivered at the VA.~   "
35980|NCT02586051|"~     This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered~     as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants~     will be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2)~     obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk~     of infusion-related reactions (IRRs). In Cohort 1, 5 participants will receive single dose~     obinutuzumab IV infusion on Day 1. Following review of Cohort 1 aggregated safety data up to~     4 weeks post dose for the last participant of cohort 1, cohort 2 will be allowed to proceed.~     In Cohort 2, 20 participants will receive obinutuzumab IV infusion on Days 1 and 15.~     Participants who qualify for transplantation and receive a compatible kidney offer after~     inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of~     transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of~     the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the~     desensitization phase and at Week 28 post-transplantation. All participants will be~     monitored for a minimum of 12 months following the last obinutuzumab infusion.~   "
35981|NCT02586038|"~     This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE,~     MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, MLN-DEXAMETHASONE-BENDAMUSTINE or MLN-~     THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly~     diagnosed elderly Multiple Myeloma patients.~      260 patients, males and females, older than 65 years old or younger but considered not~     eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will~     take part in this study.~      The duration of the study is approximately 5 years.~   "
35982|NCT02586025|"~     This is an Asia-Pacific regional, randomized, double-blind, Phase III, multicenter trial~     designed to evaluate treatment with trastuzumab plus pertuzumab plus docetaxel compared with~     trastuzumab plus placebo plus docetaxel in chemotherapy-naïve patients with early-stage or~     locally advanced HER2-positive breast cancer. The anticipated treatment duration is~     approximately 17 months.~   "
35983|NCT02586012|"~     Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which~     promotes blood clotting is missing or does not work properly. Individuals with hemophilia A~     are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII~     (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among~     patients with hemophilia. Some studies have shown that obese hemophilia patients may be able~     to prevent bleeding with a lower dose of clotting factor than the dose they are currently~     receiving. The lower dose is calculated based on what a patient should weigh rather than~     what he does weigh. This is a clinical research study to test whether calculating rFVIII~     dosing based on lean body mass and ideal body weight (what a person should weigh based on~     his height) in overweight and obese patients with hemophilia is more accurate than~     calculating rFVIII dosing based on what a person actually weighs.~   "
35984|NCT02585999|"~     Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of~     estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The~     primary objective is to assess the change in serum Ethinyl Estradiol (EE2) levels over 12~     weeks of continuous contraceptive patch use. Additional objectives include assessing the EE2~     area under the curve (AUC) during the study time period, as well as Norelgestromin (NGMN)~     levels and NGMN AUC over the 12 weeks of continuous contraceptive patch use.~   "
35985|NCT02585986|"~     The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an~     antiinflammatory and modulating activity on immunological processes, with positive results~     on different inflammatory and atopic conditions.~   "
35986|NCT02585973|"~     This open label, single-arm, Phase 1b study is designed to identify the maximum tolerated~     dose (MTD) using a traditional 3+3 dose escalation design of the WEE-1 inhibitor AZD1775~     when added to standard of care chemotherapy (cisplatin) and radiation for the treatment of~     locally advanced squamous cell cancer of the head and neck (HNSCC).~   "
35987|NCT02585960|"~     1. To compare the efficacy and safety of PK-guided treatment with BAX 855 targeting FVIII~          trough levels of 1-3% and approximately 10% (8-12%)~        2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX~          855~   "
35988|NCT02585947|"~     The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV)~     reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with~     rituximab and compare HBV reactivation rates by duration of prophylactic treatment with~     tenofovir to contribute to the establishment of an effective prevention strategy.~   "
35989|NCT02585934|"~     This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an~     adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.~   "
35990|NCT02585921|"~     The number of persons actively waiting on the national solid organ waiting list continues to~     rise while the number donating organs has failed to keep pace. This is a particular problem~     for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents~     are an important group for organ donation efforts as they have not yet applied for a~     driver's license and represent the majority of future donors. Yet many organ donation~     interventions have not targeted adolescents. The investigators propose to utilize existing~     high school teen summits developed by our Consortium partners to evaluate the effectiveness~     of existing donation interventions. Together, the investigators will conduct a randomized~     controlled 2x2 factorial trial to evaluate the independent and combined effects of two donor~     education interventions on consent for organ donation on the electronic Ohio Donor Registry.~     One thousand six hundred students over the age of 15.5 years from Cleveland-area high~     schools will be enrolled.~   "
35993|NCT02585882|"~     This was a block-randomized, controlled, open-label trial and was executed in two preschools~     in The Gambia. Fluoridated table salt (250 mg F/kg salt) was administered in daily communal~     preschool feeding. In total, 304 children in the test group and 137 children in the control~     group, aged 3 to 5 years were enrolled according to inclusion criteria (complete primary~     dentition and a parental or legal guardian informed consent). Mean difference of incidence~     of cavitated carious lesions (Δd3/4mft) after 12 months was the primary end point. The~     relative preventive dental caries effect was. Secondary end points were the difference of~     incidence of white spot lesions and the difference of incidence of total carious lesions.~   "
35994|NCT02585869|"~     The purpose of this study is to evaluate the effect of gemcabene on HDL‐C, LDL‐C, TG, and~     other lipid levels in patients with low HDL‐C~   "
35995|NCT02585856|"~     The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in~     increasing the survival time, decreasing cholestasis and improving health-related quality of~     life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable~     cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the~     procedure.~   "
35996|NCT02585843|"~     This is a prospective, single-center, double-blind and randomized placebo controlled trial~     for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution~     of signs and symptoms of congestion in outpatients with acute decompensated heart failure~     (ADHF). Patients who are not responding to their current loop diuretics will be considered~     for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of~     care in management of heart failure (HF) patients. However, recommended doses of MRAs~     (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and~     symptoms of volume overload. Therefore, the proposed study will aim to show the impact of~     this outpatient regimen to improve diuresis and possible reduction in hospitalization for~     further diuretic management in HF patients with signs and symptoms of congestion.~   "
35997|NCT02585830|"~     This study examines the relationship between sleep timing and insulin resistance in~     adolescents with obesity. The investigators also aim to develop a physiologically-based~     mathematical model of adolescent sleep/wake and circadian interactions.~   "
35998|NCT02585817|"~     This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED~     management model incorporating advanced technological innovation to promote a paradigm shift~     to patient-centered care involving remote CIED monitoring and programming. The advancement~     in technology is very important as it addresses several potential gaps and barriers in the~     care of patients with CIEDS:~        1. Long, expensive travel for patients~        2. Morbidity to patients due to delay in receiving appropriate treatment~        3. Efficiency in health care delivery~        4. Patient satisfaction~   "
35999|NCT02585804|"~     Patients with Focal Segmental Glomerulosclerosis (FSGS) constitute an increasing proportion~     of the total glomerulonephritis (GN) patient cohort in North America while FSGS is a risk~     factor for end stage renal failure. Current non-immunological FSGS therapies include the use~     of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers~     (ARB), to reduce intraglomerular hypertension. Unfortunately, these agents lead to~     incomplete renal protection. The aim of the current study is to determine whether the~     addition of novel sodium glucose cotransport-2 inhibitors (SGLT2i) to standard of care leads~     to reduced intraglomerular pressure and suppression of proteinuria. We hypothesize that~     combination therapy of SGLT2i drugs and conventional RAASi results in additive renal~     protective effects in FSGS patients. A further goal is to examine mechanisms of SGLT2~     inhibition by measuring renal hemodynamic function and sodium handling. Kidney function will~     be assessed in FSGS patients before and after an 8 week treatment with SGLT2i dapagliflozin.~   "
36000|NCT02585791|"~     This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor~     generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by~     measuring changes in nasal ion transport and TGF-β levels. Nasal ion transport will be~     assessed by nasal potential difference (NPD). TGF-β levels (mRNA and protein by ELISA) will~     be assessed on nasal cells and lavages.~   "
36001|NCT02585778|"~     Primary Objectives:~        -  To demonstrate the superiority of alirocumab in comparison with placebo in the~          reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with~          diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk~          not adequately controlled on maximally tolerated LDL-C lowering therapy.~        -  To evaluate the safety and tolerability of alirocumab in patients with diabetes treated~          with insulin.~      Secondary Objective:~      To demonstrate that alirocumab is superior in comparison to placebo in its effects on other~     lipid parameters (ie, measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C],~     apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)]), high density~     lipoprotein cholesterol (HDL-C), triglyceride (TG) levels, triglyceride rich lipoproteins~     (TGRL), apolipoprotein A-1 (Apo A-1), apolipoprotein CIII (Apo C-III), and LDL particle~     number and size).~   "
36002|NCT02585765|"~     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is~     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of~     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since~     being injured. Despite the increasing attention and emphasis on prevention, PUs still~     represent a major health risk for persons with SCI. Among the numerous potential physical~     risk factors identified for the development of a PU were several conditions that have a~     significant negative effect on skin blood flow. In addition, improper management of blood~     sugar is a major risk factor for PU development and it impedes healing. It would appear that~     hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that~     target the blood vessels may play an important role in the development and formation of a~     PU. In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps~     the body use sugar and also relaxes the blood vessels allowing blood flow to increase) in~     the lower extremity were shown to be much lower than healthy individuals.~      The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic~     region PU has 2 phases: (1) a 4-week observation phase [if the PU does not heal~     appropriately (determined by digital photos and software computation), and the subject is~     found to be insulin resistant then they will progress to the next phase of the study] and~     (2) an 8-week treatment phase. All participants will continue to receive the standard~     wound care throughout the observation and treatment phases. If the surface area of the PU~     does not decrease by more than 30% during the 4-week observation phase, the participant will~     be eligible to enter the 8-week treatment phase, in which they will be randomly assigned to~     receive active drug (e.g., pioglitazone) or placebo. The participants will have four study~     visits in which the following will be acquired: digital image of the wound to monitor wound~     surface area, skin blood flow measurements of the peri-wound area, and blood tests to~     monitor liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose),~     nutritional status (albumin and pre-albumin), a complete blood count with differential, and~     makers of inflammation. Weekly monitoring of symptoms and participant experiences will be~     closely monitored.~   "
36003|NCT02585739|"~     Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has~     been suggested by family and twin studies, but the mode of transmission seems to vary and~     the amount of heritability is unclear.~      The number of genetic association studies investigating variants implicated in the~     pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms~     have been associated with CH. The former has been confirmed and may affect the hypothalamic~     hypocretin system. The aim of the present study was to investigate the possible link between~     SPINK 1 gene and cluster headache.~   "
36004|NCT02585726|"~     The VenaSeal Closure system offers an outpatient treatment option for the permanent closure~     of lower extremity superficial truncal veins, such as the great saphenous vein (GSV),~     through endovascular embolization with coaptation. VenaSeal is intended for use in adults~     with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).~   "
36005|NCT02585713|"~     This randomized phase III trial studies the side effects of and compares apixaban and~     dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism.~     Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks~     off and moves through the bloodstream. Patients with cancer are at increased risk for venous~     thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming~     or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin~     is more effective in reducing blood clots in patients with cancer related venous~     thromboembolism.~   "
36006|NCT02585700|"~     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of~     participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;~     A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female~     adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo~     (30).~   "
36007|NCT02585687|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence~     of 500 000 cases per year. HCC most commonly appears in a context of liver chronic disease~     (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis).~     Surgical resection and liver transplantation concern patients with early stage and are the~     only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and~     antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).~      Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the~     blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is~     usually assessed by methods based on morphological medical imaging. The measures of each~     target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria~     and WHO.~      However, these morphological measures are not fully evaluated. An alternative to these is~     the functional medical imaging which assess changes before that a diminution of tumor size~     is detectable. Since these treatments induce generally necrosis without modification of~     initial tumor size, the new technologies of functional medical imaging are particularly~     adapted to an early evaluation of the response to treatments which may improve patient~     management.~      In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict~     the response of antiangiogenic treatments.~      Positive results will enable to adapt therapy in order to improve overall survival of~     patients and avoid expensive treatments which may turn out to be inefficient and generating~     important side-effects.~   "
36008|NCT02585674|"~     Primary Objective:~      To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine~     Titration Meter) device-supported treat-to-target regimen relative to a routine titration~     regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting~     self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2~     mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.~      Secondary Objective:~      To assess the efficacy, safety, and adherence/satisfaction of MyStar DoseCoach~   "
36009|NCT02585661|"~     Determination of fractional iron absorption from dairy product fortified with 2 labelled~     iron compounds~   "
36010|NCT02585648|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease.~      Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by~     the use of artificial tears during the day. Nighttime relief is often achieved by substances~     known to be more adhesive to the ocular surface, such as gels.~   "
36011|NCT02585635|"~     The MOrPH study is designed to identify optimal prophylaxis schedules for children with~     haemophilia. This involves development of combined pharmacokinetic and pharmacodynamic~     models. Interpretation of model outputs will be informed by two surveys. The first will~     survey families of children with haemophilia to ascertain families' values and preferences~     concerning prophylaxis schedules. The second will survey haemophilia physicians to ascertain~     the criteria physicians use to prescribe prophylaxis schedules.~   "
36012|NCT02585622|"~     The study will investigate, primarily, the safety, feasibility and tolerability and,~     secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal~     Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and~     progressive diabetic kidney disease (DKD).~   "
36013|NCT02585609|"~     The primary focus of this clinical study is the objective and subjective measurements of~     sleep quality in patients with advanced cancer using opioids. It also examines sleep~     disturbances and associations between sleep quality and symptoms in order to improve symptom~     management in patients with advanced cancer.~      The overall aim of this study is to improve the clinical understanding of sleep quality in~     patients with advanced cancer using opioids and to improve the understanding of how sleep~     quality may best be measured in order to improve symptom management.~   "
36014|NCT02585596|"~     This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients~     with chronic periodontitis, in order to investigate the recommended therapeutic dose.~   "
36177|NCT02583464|"~     Objective: To evaluate the relative bioavailability of a new formulation containing a~     combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare~     this formulation with the branded formulation (R) to meet regulatory criteria for marketing~     the test product in Argentina.~   "
36178|NCT02583451|"~     This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study~     of lemborexant in healthy adult and elderly subjects to evaluate driving performance~   "
36015|NCT02585583|"~     The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently~     becoming a new and well defined treatment paradigm.~      The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which~     offers the advantage of a better patient's compliance by avoiding local anaesthesia and the~     discomfort due to wearing the frame for the period of time needed for the whole procedure.~      Unfortunately the subtle but substantial differences about the 3D dose distribution and the~     dose fall-off features between GK and CK made mandatory investigations about the~     effectiveness and the safety when the cyberknife is used.~      Particularly the minimum effective and safety dose have to be defined yet A previous study~     (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy.~      The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy,~     130 Gy and 140 Gy.~      The safety and the targeting methodology will be also in investigated.~   "
36016|NCT02585570|"~     The purpose of this study is to determine whether phenylephrine infusion are effective in~     the prevention of hypotension after changing position to beach chair position during general~     anesthesia for shoulder arthroscopic surgery.~      Investigators hypothesized that by increasing arterial blood pressure with phenylephrine~     infusion, incidence of hypotension would be decreased.~   "
36017|NCT02585557|"~     The objective of this study is to determine if primary care practice support accelerates the~     dissemination and implementation of patient-centered outcome results (PCOR) findings to~     improve heart health and increases primary care practices' capacity to incorporate other~     PCOR findings in the future.~   "
36018|NCT02585544|"~     Day surgery is performed in the same way as in full hospital admission, allowing same-day~     discharge without increased risk. It provides many grounds for patient satisfaction.~     Progress in surgical and anesthesia techniques now allows this form of management to be~     developed and prioritized.~      Day-care surgery for prolapse has been little studied. The present study is intended to help~     extend its future implementation, the primary objective being to assess the feasibility of~     the day-care approach in prolapse surgery. The secondary objectives are to study criteria of~     non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of~     failure, predictive factors for failure, patient satisfaction, postoperative complications,~     2-year anatomic and functional results, pain, quality of life and sexuality, and~     postoperative onset of dyspareunia and urinary incontinence.~      The design is for a prospective non-randomized study conducted in 3 gynecologic surgery~     sites managed by the Lyon hospitals board (Hospices Civils de Lyon).~   "
36019|NCT02585531|"~     Bronchiolitis is one of the main reasons for consultation in primary care and emergency~     services, as well as the leading cause of hospitalization for lower respiratory tract~     infection in children under two years. There is still no consensus on the medical management~     of the disease, in clinical practice there is wide variability in the treatment with inhaled~     drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of~     the disease, which results in increased morbidity and a major economic benefit for all~     health services.~      Several studies are in relation to the management of bronchiolitis, one of which was made~     during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing~     3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira)~     (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of~     ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management~     of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was~     demonstrated, it was not possible to establish difference statistically significant between~     them. Why it was considered necessary to continue the study focused on determining the~     difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this~     investigation is to determine whether there is a difference between the use of dexamethasone~     and epinephrine versus hypertonic saline (3%).~   "
36020|NCT02585518|"~     The current study seeks to elucidate the context of pathological and non-pathological eating~     behavior in a heterogeneous sample of overweight and obese children, aged 8-14 years.~     Children will undergo a two-week ecological momentary assessment (EMA) protocol in which~     they record all eating episodes and their physiological, emotional, interpersonal, and~     environmental correlates. Specific aims are to identify proximal antecedents and~     consequences of pathological and non-pathological eating in overweight and obese children,~     and to determine the prevalence of loss of control eating in the natural environment.~   "
36021|NCT02585505|"~     Stem cells have promising potential in treating diabetes. However the therapeutic outcome in~     diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to~     label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled~     stem cells will be given through different routes (intravenous and intraarterial)and tissue~     distribution studied. Patients will be followed up for the next 6 months. Glucagon~     stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta~     will be calculated.~   "
36022|NCT02585492|"~     The purpose of this study is to determine if the position of the mother in the first two~     hours after delivery, while she is in skin to skin contact with your child, influences the~     oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful~     information for the prevention of seemingly lethal episodes or sudden death of the child~     when, following current recommendations is skin to skin contact in the first hours of life.~     These episodes are communicating in all developed countries and have caused great concern~     and interest in the scientific community. So far we only have information from case series.~   "
36023|NCT02585479|"~     The purpose of this study is to determine that systemic chemotherapy is superior to~     transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in~     patients with Advanced Hepatocellular Carcinoma.~   "
36024|NCT02585466|"~     Reports have been appearing in literature over the past years of various~     nociception-antinociception monitors, introduced and promoted from major manufactures.~     Recently a new term Practice misalignment has been recently coined indicating research~     study groups that are distant from daily anesthesia practice, with some scientific relevance~     but very little clinical relevance simulating purely hypothetical conditions that are not~     related to everyday anesthesia practice.~   "
36179|NCT02583438|"~     The intestinal microflora imbalance has been associated with obesity and type 2 diabetes.~     The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in~     patients with newly diagnosed type 2 diabetes.~   "
36025|NCT02585453|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, exact information about the tear film thickness and the corneal residence~     time of topical lubricants is still sparse, therefore no ideal treatment regimen has been~     found.~      Recently a new method for assessment of tear film thickness based on ultra high resolution~     optical coherence tomography (OCT) has become available. The aim of the present study is to~     assess tear film thickness and corneal residence time of three different formulations of~     topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane®~     Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard~     tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I~     test and determination of tear break up time (BUT) will be performed.~   "
36026|NCT02585440|"~     This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of~     CMX157 at increasing dose levels.~   "
36027|NCT02585427|"~     It is now recognized that diet plays a critical role in the etiology and management of the~     chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of~     fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The~     glycaemic index (GI) is a measurement of the ability of different types of~     carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight~     management tool has been increasing. Different types of carbohydrates differ in their~     ability to increase postprandial blood glucose and insulin secretion, and may also modulate~     the effect of different fatty acids. The current study will compare the consumption of low~     and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and~     triacylglycerol responses in healthy participants.~      The data generated will have direct applications in public health policy and clinical~     nutrition management of chronic disease. The outcomes of the study will significantly~     contribute to the long term national goals of Singapore to manage and to reduce the~     incidence of chronic disease associated with the metabolic syndrome.~   "
36028|NCT02585414|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe~     consequences for affected patients. DES can be either caused by decreased tear production or~     increased tear evaporation, both leading to an instable tear film. Despite many efforts,~     generally accepted methodologies to diagnose, assess the severity and monitor DES are still~     lacking. Moreover, widely used clinical methods such as tear break up time (BUT),~     fluorescein staining of the cornea or Schirmer test only poorly reflect patients´ complains.~      One of the main problems in the diagnosis and treatment of DES is that the most critical~     component - the tear film itself - is difficult to characterize. The development of new~     ultra-high resolution optical coherence tomography systems allows now for the direct~     visualization of the human tear film and for the non-invasive in-vivo measurement of tear~     film thickness (TFT). The investigators could recently show that this system provides~     excellent reproducibility and is able to assess even subtle changes in TFT induced by~     therapeutic interventions. However, to which extent tear film thickness is associated with~     other standard clinical measures of DES is currently unknown. In the present study, the~     investigators set out to test the hypothesis that ocular TFT is a new and good surrogate~     parameter for the assessment of the severity of DES.~      Consequently, the aim of the study presented in this protocol is to investigate whether and~     if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular~     TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES~     will be performed. This should allow the investigators to more specifically characterize the~     role of the tear film in DES and to assess whether measurement of TFT with OCT can be a~     promising surrogate parameter for the diagnosis and the follow up of DES.~   "
36029|NCT02585401|"~     The primary objective of this study is to measure physician knowledge and understanding of~     the key safety information contained in the Eylea vial preparation instruction card, the~     intravitreal injection procedure video, and the product monograph.~   "
36030|NCT02585388|"~     The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase~     and metronomic chemotherapy treatment~   "
36031|NCT02585375|"~     Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most~     of these eye drops contain preservatives to allow for the use of multi-dose containers. In~     the recent years evidence has, however, accumulated that these preservatives may induce~     ocular surface disease (OSD). This is particularly true for the most widely used~     preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro~     and animal studies, evidence from clinical trials is sparse. The only randomized masked~     study that showed superiority is a pivotal company-sponsored study indicating improved~     tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops.~      The investigators have recently introduced an optical coherence tomography (OCT) technology~     that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the~     investigators were able to show that tear film thickness (TFT) is negatively correlated with~     symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level~     of resolution as also evident from studies after administration of lubricants.~      In the present study, the investigators hypothesize that switching glaucoma patients from~     preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase~     in TFT as measured with OCT. As a control the investigators will use preserved latanoprost~     and the study hypothesis will be tested in a randomized, controlled, single-masked parallel~     group design. TFT is chosen as main outcome variable, standard measures for signs and~     symptoms of OSD are selected as secondary outcomes. The present study may provide valuable~     information on the superiority of unpreserved versus preserved therapy.~   "
36032|NCT02585362|"~     This study evaluates physical performance in cancer outpatients during a multimodal therapy.~     Half of the patients will receive physical exercise und nutrition program in combination~     with a specially formulated whey protein supplement, while the other half will receive~     standard care.~   "
36053|NCT02585089|"~     Spanish dry-cured ham has been shown a source of antihypertensive peptides in mice. To date,~     no clinical study has been performed in humans to check the effects of bioactive peptides~     produced naturally during the processing of pork dry-cured ham on blood pressure. Therefore,~     the aim of the present study is to investigate whether consuming peptides from cured pork~     ham with demonstrated angiotensin I-converting enzyme (ACE) inhibitory activity lowers blood~     pressure (BP) and improves other risk factors for cardiovascular disease (CVD).~      Objectives: To demonstrate the lowering effects of bioactive peptides from cured pork ham~     with >10 months dry-curing process in humans. To check for other possible benefits related~     to dry-cured ham intake such as: platelet activation and cardiovascular risk factors.~   "
36180|NCT02583425|"~     Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache~   "
36033|NCT02585349|"~     Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the~     Netherlands of middle and old age every year. Due to the aging of the population, this~     figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five~     percent of stroke patients die within one month, making stroke a major risk factor for~     premature death in developed countries. According to the World Health Organization, stroke~     is the third leading cause of the burden of disease in middle and high-income countries~     (World Health Organization, 2008). It has a significant negative impact on quality of life~     of both the patients as well as their caregivers and significant others. Surviving stroke~     patients often struggle with its manifold and lifelong lasting consequences, with 35 percent~     of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive~     and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, &~     Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and~     significantly contribute to the burden of the disease, but their etiologies remain poorly~     understood.~      The aim of the CASPER study is to gain more insight into the etiologies of post-stroke~     depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and~     post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based~     predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially~     the interaction between cerebrovascular disease, neurodegenerative changes and inflammation~     in post-stroke dementia.~      CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients~     with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after~     baseline.~   "
36034|NCT02585336|"~     Sugar-sweetened beverages (SSBs) have been epidemiologically linked to serious health~     problems including heart disease, liver disease, and diabetes. This study will recruit~     frequent SSB drinkers who are employees at the University of California, San Francisco~     (UCSF) and measure markers of metabolic health on two occasions, 10 months apart. During~     this time, UCSF will cease selling SSBs at all campus and medical center locations.~     Additionally, at the first assessment half of participants will be randomly assigned to a~     brief intervention to help reduce SSB consumption, consisting of a 10-20 minute~     semi-structured interview designed to share health information about SSBs, elicit~     motivations to reduce consumption, and help set concrete plans to reduce consumption. The~     investigators will be able to compare changes in metabolic health among those who do and do~     not reduce SSB consumption. This will make a unique contribution to the growing evidence~     regarding both the effects of SSB consumption on health and the modifiability of SSB-related~     health conditions.~   "
36035|NCT02585323|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more~     per week. The primary goal of this randomized controlled trial is to assess the efficacy of~     a Fitbit Flex (a wireless physical activity tracking device) paired with a new application,~     plus a brief education session and telephone counselling by a physiotherapist (PT), to~     improve physical activity and reduce sedentary time in patients with knee osteoarthritis.~   "
36036|NCT02585310|"~     In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and~     frequent (number of patients receiving blood). The incidence of side effects are unknown, as~     is the exact amount of blood used/provided for patients with elective CABGs.~      The primary objective of this study was to demonstrate the incidence of packed red blood~     cell (PRBC) transfusion in elective CABGs.~   "
36037|NCT02585297|"~     Study Goals:~        1. Finding the prevalence of bacteria of the sperm in an innovative and more accurate~          methode~        2. Understanding the effect of microbes on the process of capacitation~        3. The impact of microbes in the sperm on IVF success rate~        4. Finding the incidence of vaginal bacteria and their relationship to bacteria of the~          sperm~        5. The impact of vaginal flora on IVF success rate~   "
36038|NCT02585284|"~     Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS)~     value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at~     BIS value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived~     from a database of mostly relatively fit, young healthy volunteers. To date there are no~     studies precisely quantifying BIS response to propofol concentrations among different age~     groups~   "
36039|NCT02585271|"~     The purpose of this study is to compare the clinical outcomes of transanal decompression~     tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided~     colonic and rectal obstruction.~   "
36040|NCT02585258|"~     Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in~     treatment strategies for elderly patients with rheumatoid arthritis:~      The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)~   "
36041|NCT02585245|"~     This research study will compare two different screens for nutrition risk in patients who~     are in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it~     is as good and consistent as the standard NRS 2002 Nutrition Risk Screen.~   "
36042|NCT02585232|"~     The purpose of this randomized controlled pilot study is to examine the preliminary~     effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms~     and spousal relationship status) of a newly developed intervention for individuals with~     dementia and their family caregivers that combines elements of the established care~     consultation (CC) approach with additional counseling modules (CC+C). Outcomes for Veterans~     with dementia and their family caregivers (e.g., depressive symptoms, care-related burden,~     quality of life, pleasant events, etc.) will be assessed after 6 months of treatment and~     again at 12 months.~   "
36078|NCT02584764|"~     The primary aim is to develop, and test the feasibility and efficacy of, a manual based,~     cognitive behaviour therapy (CBT) treatment for Hoarding Disorder (HD) delivered in a group~     format combined with an Internet support system. The investigators' secondary aim is to~     investigate the neurocognitive profile of the participants before and after treatment in~     order to explore if the treatment might have an impact on neurocognitive functioning and if~     certain neurocognitive profiles predict outcome.~      For the primary aim, the investigators hypothesize that the treatment will be acceptable to~     participants and decrease symptoms of hoarding. Regarding the secondary aim, the~     investigators hypothesize that deficiencies in executive functioning, as measured with a~     neurocognitive battery, will reduce upon completion of treatment and that baseline executive~     function will be associated with treatment outcome.~   "
36043|NCT02585219|"~     The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which~     shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing~     the difference between the background and the tumor to be realively high. In addition, there~     is relatively little 11C-MET uptake in inflammatory processes. This makes 11C-MET a very~     suitable positron emission tomography (PET) tracer in order to differentiate between tumor~     progression and therapy changes. The latter is a major clinical problem for which further~     investigation is necessary.~      In order to be able to make this differentiation, a direct post-operative baseline scan is~     required. With regard to the advanced MRI sequences, it is known that it is necessary to~     produce the post-operative baseline scan within 48 hours. After that timeframe, operation~     induced changes start to occur, such as granulation tissue. In that case the interpretation~     of the scan is no longer possible. Immediately postoperatively (<48 hours) 11C-MET has never~     been used before. Therefore, it is unknown whether 11C-MET provides a good baseline scan~     directly after surgery. This pilot will investigate the feasibility of this 11C-MET baseline~     scan and comparison the results with the advanced MRI sequences.~   "
36044|NCT02585206|"~     This study is comprised of 2 phases to study the impact of a text message system on overall~     adherence to a web-based smoking cessation program. Phase I uses a full factorial design to~     identify the most optimal text message intervention to maximize adherence to the~     BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that~     compares regular BecomeAnEX users to those who will receive the optimized text message~     intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term~     abstinence.~   "
36045|NCT02585193|"~     While some evidence on weight change elicited from commercially available weight loss~     programs, such as Weight Watchers, is available, there is little evidence evaluating any~     health-related outcomes that result from losing weight through these programs. In addition,~     little data exists on the adherence and satisfaction of these types of programs. The purpose~     of this study is to evaluate body weight and health-related outcomes that are achieved from~     participating in a Weight Watchers program, along with program adherence and satisfaction.~     Men and women (N=150) that are participating in Weight Watchers weight loss program will~     undergo assessments at the University of Pittsburgh to evaluate outcomes related to the~     Weight Watchers 6 month intervention. Assessment visits, separate from the intervention,~     will take place at baseline (0 months), 3 months and 6 months for approximately 90 minutes~     at the Physical Activity and Weight Management Research Center. Participants will be asked~     to undergo assessments of body weight, height, aerobic stamina, functional fitness,~     flexibility, and complete a series of questionnaires related to demographics, program~     satisfaction, sleep quality, happiness, and food cravings. Adherence to the program will be~     measured by the number of group sessions attended.~   "
36046|NCT02585180|"~     Many studies provide evidence for the benefit of lower respiratory tract surveillance,~     mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially~     multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing~     the medico-economical impact of the subglottic secretions drainage (SSD) provides the~     opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to~     predict pathogens involved in VAP (in comparison with the concomitant endotracheal~     secretions surveillance). These subglottic and tracheal secretions culture surveillance will~     be masked to the investigators of the DEMETER Study.~      This ancillary study will be performed in 14 centers participating to the DEMETER study~   "
36047|NCT02585167|"~     This is a randomised controlled trial to evaluate the outcome of treatment of complex~     perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy~     and sphincter reconstruction as standard surgical procedure.~   "
36048|NCT02585154|"~     Parkinson's disease (PD) is a common, disabling, progressive condition characterised by~     severe problems with movement for which medical treatment in the longer term can be~     unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the~     nerve cells affected inside the brain to help overcome the difficulties with movement.~     Classically, DBS stimulates in a manner that is constant and independent of a patients~     underlying condition as reflected in their brainwave activity. Recent research has suggested~     that adjusting DBS in real time using analyses of brain signals recorded from DBS electrodes~     (termed closed loop DBS) nay be better than classical DBS in alleviating difficulties with~     movement. However, it remains unclear whether closed-loop DBS also leads to fewer unwanted~     side effects on movement control.In order to answer this question, the investigators will~     analyze DBS activity and activity recorded from the surface of the head in PD patients~     undergoing DBS surgery. During the recordings patients will perform different movement~     tasks. DBS has been found to reduce patients' ability to suppress inappropriate movements in~     certain tasks and performance in these tasks will be the core point of interest. The~     recordings will be conducted three times: During closed loop DBS, classical DBS and while~     the stimulator is turned off. This will allow the investigators to assess putative~     differences in the effect of closed loop and classical DBS with regards to wanted and~     unwanted effects on movement control and to elucidate their correlates in the brain.~   "
36049|NCT02585141|"~     The purpose of this study is to compare aspiration and oral antibiotics with surgical~     incision in the treatment of perianal abscesses in terms of recurrence and subsequent~     fistula formation. Included patients will be randomised to either aspiration or incision.~   "
36050|NCT02585128|"~     Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive~     characteristics: they are old, frail, with several co-morbidities and take multiple~     medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and~     hospitalization in intensive care expose those patients to postprocedural delirium.~      Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.~      The objective of this study is to determine the incidence of delirium and neurocognitive~     disorders in elderly patients after TAVI.~   "
36051|NCT02585115|"~     The aim of this study is to determine if sampling technique of urine affects diagnostic~     modalities in primary care. Furthermore it aims to determine if there is difference in the~     accuracy of the point-of-care test, when the urine sample is stored at room-temperature and~     analyzed later in the day.~   "
36052|NCT02585102|"~     The purpose of this study is to see if perceived barriers to vegetable consumption can be~     overcome by making it easier for people eat more vegetables and to see if the effects last~     over time.~   "
36054|NCT02585076|"~     Arterial hypertension has been recognized as a major causal factor for atrial fibrillation~     (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing~     prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic~     events and mortality, AF has emerged as a global healthcare problem.~      Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for~     the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the~     management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use~     of a risk factor-based approach to stroke risk stratification for AF patients.~      This study aims towards gaining real-world data on the prevalence of non-valvular atrial~     fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent~     antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors~     influencing treatment decision-making will be assessed as well in patients diagnosed with~     the arrhythmia.~      Finally, potential differences in the NVAF prevalence in adequately and inadequately~     controlled hypertensives will be documented.~   "
36055|NCT02585063|"~     The UK government's Crown report titled 'Review of prescribing, supply & administration of~     medicines' enabled optometrists to train for the qualification of independent prescribing~     (IP). The UK introduced IP for optometrists in 2009. The proposed research focuses on the~     role of IP optometrist in the acute ophthalmic services of Manchester Royal Eye Hospital~     (MREH). The study will compare IP optometrists to consultant ophthalmologists in the ability~     to diagnose, manage and prescribe medication for patients accessing these services.~      To achieve this comparison consenting participants will first have a clinical assessment~     with the IP Optometrist, where findings including diagnosis and management plan will be~     recorded onto a research proforma. The consultant ophthalmologist will be masked to the IP~     Optometrist's research proforma to prevent bias. The consultant ophthalmologist will then~     perform a clinical assessment on a second proforma and inform the participant of their~     diagnosis and management plan. Percentage agreement, kappa (κ) and weighted κ will be~     calculated for a range of parameters between the two proformas. Disagreement in diagnosis or~     management will be arbitrated by a separate ophthalmologist participating in the study with~     a specialty relevant to the participant's condition.~      The main objective of the research is to expand the limited base of evidence of of IP~     optometrists' ability to diagnose, manage and prescribe medication and to determine whether~     they work at least as safely and effectively as consultant ophthalmologists in acute~     ophthalmic services. It is the first study in this area since the advent of IP for~     optometrists, with only one previous study published before IP was introduced. The research~     will enable the type and frequency of conditions presenting in these services to be~     measured. Furthermore it will identify conditions that IP optometrists can manage~     independently and enable guidelines for these conditions to be developed.~   "
36056|NCT02585050|"~     Debates about the official and legal implementation of Do not attempt resuscitation (DNAR)~     orders are ongoing. The aim of this study was to determinate factors that influence~     neurological outcomes at discharge and the ratio of living patients discharged from the~     hospital due to DNAR prohibition.~   "
36057|NCT02585037|"~     The Kinesio Taping® method, therapeutic bandage, is another feature can be used in physical~     therapy, aiming to muscle enhancement, weakened muscles correction, analgesia, among others,~     by cutaneous stimulation of mechanoreceptors. This study aims to evaluate the efficiency of~     the use and effects offered by Kinesio Taping® method, changes in muscle strength of grip in~     normal subjects for clinical application.~   "
36058|NCT02585024|"~     A number of pharmacotherapies are available for smoking cessation in New Zealand including~     nicotine replacement therapy, bupropion, an antidepressant medication and varenicline. Of~     these, varenicline is the most effective, but also the most expensive. Varenicline acts like~     nicotine and stimulates nicotine receptors in the brain, but to a lesser extent, and~     simultaneously block nicotine binding to its receptors and thus reduces the rewarding~     effects of cigarette smoking. Cytisine (Tabex® and Desmoxan®) is a plant alkaloid and also~     acts in a similar way to varenicline but is significantly cheaper. It has been used for more~     than 50 years in some parts of eastern and central Europe as an aid to quit smoking, but is~     not approved for use in many countries such as New Zealand, Australia, the UK or the US.~     Randomised, placebo-controlled trials have shown that cytisine is more effective than~     placebo and nicotine replacement therapy (NRT)for smoking cessation. However there is a~     paucity of pre-clinical data on cytisine. In particular, there are limited data on the~     pharmacokinetic and the dose response characteristics of cytisine. Furthermore, the current~     dosing regimen recommended by the manufacturer is complex and has no clear basis in~     empirical research.~      Complexity of dosing has been shown to be a key factor in determining adherence. Therefore,~     a simpler regimen would likely maximise the effectiveness of treatment through improved~     adherence to the treatment regimen. The investigators therefore propose to undertake two~     studies to investigate the influence of dose, dosing frequency and dosing duration on the~     pharmacokinetics and tolerability of cytisine and cigarette craving in smokers.~   "
36059|NCT02585011|"~     At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures,~     250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways~     reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the~     key prerequisites for early rehabilitation is optimized pain relief. Local infiltration~     anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving~     hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local~     Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this~     study it will be investigated whether a single shot with Ropivacaine reduces acute~     postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study~     will have a direct impact on patient treatment.~   "
36060|NCT02584998|"~     The main study aim is to develop, implement and disseminate a pilot population-based mailed~     FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on~     having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic~     randomized trial to (1) Compare the effects of usual care (UC), screening invitation +~     reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder~     (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity;~     and (3) Explore barriers to use of mailed outreach screening for Veterans.~   "
36061|NCT02584985|"~     Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME).~     Originally performed by open surgery, TME demonstrated improved local control and reduced~     urogenital morbidity. Laparoscopic approach has been validated by several randomised~     controlled trials: laparoscopic approach offers to the patient a better post-operative~     recovery, a lower risk of wound hernia and comparable oncological results. However, the risk~     of conversion to open procedure remains significant.~      Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole~     pelvic dissection via a specific-moderate cost device. The procedure is then completed by a~     briefer transabdominal laparoscopic step to mobilise the colon and perform inferior~     mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this~     approach is to perform a surgical dissection via an extra peritoneal route, without~     peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area~     of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This~     approach offer closer and better exposure of pelvic dissection plane and could improve~     oncological quality and pelvic nerve preservation. It could be profitable to postoperative~     patient outcome. However rates and type of cancer-recurrences as well as functional results~     have to be assessed in a controlled study. This technique has shown to be feasible and~     reproducible through early clinical series. Conversion rates appear to be lower than~     published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of~     morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be~     comparable to laparoscopic approach results. However functional results as well as urologic~     morbidity have to be evaluated in comparative studies. In a preliminary retrospective~     comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs~     10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to~     open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038).~     Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2~     80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date,~     Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including~     several short series demonstrating the feasibility of the technique and showing low~     morbidity. For some authors the benefit of transanal approach is significant in difficult~     cases such as male patient and narrow pelvis. Very recently, two non randomised comparative~     studies were published with conclusions close to those in our study.~      Investigators propose, with the support of the GRECCAR group, to conduct a national,~     multicenter, open-label randomized study based on oncological non-inferiority (R1 resection~     rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard~     Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual~     colo-anal anastomosis. There is a clear expected benefit expected for the patients through~     the ETAP procedure in term of post operative short term outcome, risk of conversion to open~     procedure, risk of wound hernia.This trial could also show significant advantages in terms~     of quality of dissection, quality of the specimen, quality of nerve preservation.~   "
36105|NCT02584413|"~     Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during~     annual ophthalmologic exams. However, because these exams are annual, it is possible for~     healthcare providers to miss the point at which a child's vision begins to decline~     (potentially indicating an OPG). If at-risk children are screened for hypotonia early in~     life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to~     evaluate for OPG before they are showing ophthalmologic symptoms. This would enable~     healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier,~     thereby allowing us a better chance of preventing further vision loss in children with OPGs.~   "
36062|NCT02584972|"~     Lately, many researchers have found that Children with autism spectrum disorder (ASD) are~     most likely to have gross motor deficiencies such as lack of coordination in gait and~     balance. Much has been researched on etiology and motor learning, but only very few~     researches have examined and analyzed quantitatively gait and balance in ASD. The aim of~     this research is to analyze quantitatively balance, gait and balance during perturbation in~     children with ASD and to compare with typically developed children (TD). A group of 20~     children diagnosed with ASD and a control group of 20 TD children will be recruited and~     tested in the laboratory with well-established measures of gait and balance function. They~     will be instructed to stand as still as possible on a force plate with different task~     conditions : (1) standing with the eyes open (EO) - standing upright viewing an X~     displayed on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the~     eyes closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing~     on foam (i.e., conflicting proprioceptive information). Gait will be measured using the~     narrow base walk test, modified for clinical use. Participants will be asked to walk within~     a narrow path 6 meters long . The statistical analysis will include Independent T-tests to~     compare the ASD and controls with respect to different characteristics. General Linear Model~     (GLM) will be used by applying a separate model where the dependent variables will be the~     average values of the postural stability or gait stability parameters (continuous) and the~     independent variables were categorical by the group and task condition.~   "
36063|NCT02584959|"~     The purpose of this study is to assess the efficacy and safety of subcutaneous~     administration of a liquid formulation of C1 esterase inhibitor for the prevention of~     angioedema attacks in adolescent and adult subjects with hereditary angioedema.~   "
36064|NCT02584946|"~     The aim of the proposed study is to examine whether long-term dietary supplementation (8~     weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant~     capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among~     human subjects.~   "
36065|NCT02584933|"~     The rollover study will provide ceritinib to patients who are currently receiving treatment~     with ceritinib within a Novartis-sponsored study and in the opinion of the investigator,~     would benefit from continued treatment with ceritinib.~   "
36066|NCT02584920|"~     Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01~     and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.~   "
36067|NCT02584907|"~     In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN~     will be included. Patients will be divided into two groups. The control group with the~     standard EN and intervention group with high fat EN. 50% of the total fat will be provided~     by olive oil. Nutritional intake record form will be completed and daily calorie intake will~     be calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the~     end of the study mean blood glucose, duration of hospitalization and rate of infection will~     be compared in two groups.~   "
36068|NCT02584894|"~     The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary~     reactivation of personal traumatic memories with neuromodulation of the right dorsolateral~     prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.~   "
36069|NCT02584881|"~     Using a quasi-experimental design the investigators will compare the effect of adopting and~     implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma~     service team compared to a Level 1 trauma service team implementing standard care.~   "
36070|NCT02584868|"~     This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during~     elective open-heart surgery in pediatric patients.~   "
36071|NCT02584855|"~     The main purpose of this study is to evaluate the safety and long-term efficacy of~     ixekizumab compared to placebo in participants with active psoriatic arthritis.~   "
36072|NCT02584842|"~     The purpose of this study is to determine retrospectively if the application of rivaroxaban~     after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers~     the risk of venous thrombosis.~   "
36073|NCT02584829|"~     This phase I/II trial studies the side effects and how well localized radiation therapy or~     recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy~     works in treating patients with Merkel cell carcinoma that has spread to other parts of the~     body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Interferon beta is a substance that can improve the body's natural response and may~     interfere with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help~     T lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood~     cells are collected from the patient's blood and treated in the laboratory to recognize~     Merkel cell carcinoma. Infusing these cells back into the patient may help the body build an~     effective immune response to kill Merkel cell carcinoma. Giving localized radiation therapy~     or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy~     may be a better treatment for Merkel cell carcinoma.~   "
36074|NCT02584816|"~     This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the~     manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).~   "
36075|NCT02584803|"~     This study is to assess the feasibility of 2 different ultrasound views of the inferior vena~     cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy~     and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then~     allow us to determine the fluid status of the parturient which could be helpful in treating~     hemodynamic instability. This study will not involve any change in management of the~     participating patients.~   "
36076|NCT02584790|"~     NBI has been proven to be a useful tool to detect early NPC, but they were few studies~     concerning the detection of post-radiotherapy mucosal residual NPC using NBI system~   "
36077|NCT02584777|"~     To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of~     pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF),~     post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).~   "
36118|NCT02584244|"~     The overall goal of this feasibility study is to assess the initial safety and efficacy of~     LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers~     (adenocarcinoma) using the LUM 2.6 Imaging Device.~   "
36079|NCT02584751|"~     Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease~     (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been~     linked to respiratory symptoms and conditions such as asthma, chronic cough, and an~     increased rate of respiratory infections in the general population. In persons with asthma,~     respiratory symptoms and dependency on asthma medications have been reduced by treatment~     with anti-reflux medication. Possible mechanisms have been proposed for this link, including~     the microaspiration of reflux materials, which may result in airway acidification and~     aspiration pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors~     in the esophagus with associated esophageal inflammation and reflex bronchoconstriction.~     Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition)~     in persons with SCI on objective and subjective symptoms of respiratory function to~     determine the underlying mechanisms of airway inflammation due to GERD.~   "
36080|NCT02584738|"~     The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate~     in patient with moderate to severe asthma exacerbation in pediatric emergency~   "
36081|NCT02584725|"~     The purpose of this study is to determine the effect of increasing doses of tranexamic acid~     (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a~     change in hemoglobin from pre-operative baseline to the first post-operative day.~   "
36082|NCT02584712|"~     The aim of this study is to evaluate the effect of exercise training in the autonomic~     nervous system activity in breast cancer patients, who underwent doxorubicin medication.~   "
36083|NCT02584699|"~     This study aims to prospectively investigate the efficacy, toxicity and quality of life~     (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6~     Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009~     UICC) non-small cell lung cancer (NSCLC).~   "
36084|NCT02584686|"~     Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in~     the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal~     smooth muscles help in the treatment of resistant erectile dysfunction not responding to~     medical and injection therapy, thus avoiding surgical treatment options.~      The treatment group will be injected intracavernously with 50 units of BTX-A. The control~     group, 12 patients, will be injected with a normal saline injection.~   "
36085|NCT02584673|"~     The objective of this research is to verify the procedural improvements enabled by use of a~     CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary~     focus will be procedures performed by the Anesthesia department.~   "
36086|NCT02584660|"~     The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants~     who are discharged from the Emergency Department (ED) to the home environment and treated~     with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or~     venous thromboembolism (VTE) events through Day 30 compared to participants who are treated~     with initial hospitalization and standard-of-care.~   "
36087|NCT02584647|"~     The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be~     tolerated and result in shrinking of the cancer or stopping the cancer from growing. In the~     phase I portion, the maximum tolerate dose of the study drug will be determined. In the~     Phase II portion, progression free survival will be assessed at the dose level found in~     Phase I. Participants will continue to take the study drug until they experience an~     unacceptable side effect or their disease progresses.~   "
36088|NCT02584634|"~     The purpose of this study is to evaluate the safety and efficacy of avelumab when combined~     with either crizotinib or PF-06463922.~   "
36089|NCT02584621|"~     The proposed study is a randomized controlled trial that compares the effectiveness of an~     electronic personalized health screening app incorporating motivational feedback (i.e.~     Check Yourself) to usual care among moderate to high risk alcohol users. The purpose of~     this study is to determine whether Check Yourself is more effective than usual care in~     reducing alcohol consumption and binge drinking and improving quality of care among~     adolescents receiving school-based health clinic services.~   "
36090|NCT02584608|"~     This study is an open label use of ACTIMMUNE for patients with Autosomal Dominant~     Osteopetrosis Type 2(ADO2). Effects of treatment will be evaluated after 14 weeks on~     ACTIMMUNE by bone resorption markers. This study will treat 12 patients with ADO2 recruited~     from Indiana University and Riley Hospital for Children at Indiana University Health.~   "
36091|NCT02584595|"~     The intent of this observational study is to understand the role of non-invasive programmed~     stimulation (NIPS) to induce substrate based MMVT in patients receiving new St. Jude Medical~     ICD or CRT-D systems.~   "
36092|NCT02584582|"~     Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1)~     independent of the gastric emptying rate.~   "
36093|NCT02584569|"~     This phase 1 study will be conducted to examine the degree and duration of brain PDE2A~     enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order~     to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.~   "
36094|NCT02584556|"~     The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to~     adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free~     survival（RFS） in patients after radical resection of hepatocellular carcinoma.~   "
36095|NCT02584543|"~     This is a open label, randomized phase VI study, to assess the safety and immunogenicity of~     co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n~     =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and~     months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1~     and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at~     day 1 and months 1 and 6.~      Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs)~     were monitored for 30 days after any vaccination; serious AEs were monitored throughout the~     study.~   "
36181|NCT02583412|"~     The overall aim of this study is to determine if an accelerated Bexsero® (Multicomponent~     meningococcal B vaccine) schedule compared to a standard schedule is immunogenic, safe, and~     tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no~     formal hypothesis is tested.~   "
36096|NCT02584530|"~     This is a randomized controlled study comparing US guided vs standard procedure for PICC~     line placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal~     Intensive Care Unit who require a PICC line. Patients will be randomized using REDCap~     randomization module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked~     to ensure approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion~     procedure using anatomical landmarks and tip placement will be confirmed by X-ray (current~     standard); Arm 2: US guided PICC line insertion procedure and tip placement confirmation by~     both US and X-ray. Sample size of 33 infants per group would achieve greater than 80% power~     to detect a difference between groups.~      Primary outcome: Time to complete the standard versus the US-guided procedure.~      Secondary outcomes (comparison between two arms):~      The number of total venipuncture attempts needed to place a PICC line Number of tip~     manipulations after complete insertion Proportion of successful tip placement~   "
36097|NCT02584517|"~     Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in~     terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with~     high-dose steroids, and despite this there is a risk of flare during the treatment. Little~     is known about the initial triggers for the inflammatory process, and there are no good~     markers of response or relapse. We will study patients referred with suspected GCA to~     identify important components of the immune response in GCA, and follow them over time to~     collect evidence of how best to monitor their condition.~   "
36098|NCT02584504|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab~     administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet~     therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of~     treatment in patients with hypercholesterolemia.~      Secondary Objective:~        -  To evaluate the effect of two treatment regimens of alirocumab on other lipid~          parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non~          HDL-C), total cholesterol (TC), lipoprotein (a) [Lp(a)], high-density lipoprotein~          cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).~        -  To evaluate the safety and tolerability of alirocumab administration.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab~          administration.~        -  To evaluate the long-term safety in patients receiving open-label alirocumab~          administration.~   "
36099|NCT02584491|"~     The purpose of this study is to determine the associations between changes in neural~     activity and structure, advanced gross motor skills, gait characteristics, and physical~     activity participation following a gait-related intervention that is based on motor learning~     principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy.~     The investigators' hypothesis is that in conjunction with a program of motor learning based~     training, functional neuroplastic changes in the involved motor areas will be strongly~     associated with changes in gait and advanced gross motor skills, moderately associated with~     physical activity based participation changes, and will have a fair association with~     structural neuroplastic change.~   "
36100|NCT02584478|"~     This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding~     oral AL3818 to standard platinum-based chemotherapy concurrently and continued as a~     maintenance therapy for up to 12 months.~   "
36101|NCT02584465|"~     The objective of this randomized phase II is to evaluate the benefit of regorafenib for~     ovarian patients who reported a confirmed elevated CA-125 level under surveillance or~     bevacizumab, compared with tamoxifen.~   "
36102|NCT02584452|"~     Despite the apparent multifaceted benefit in differentiating blockade sites and duration of~     nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in~     ACL reconstruction has not been extensively studied. This study will test the hypothesis~     that the use of the adductor canal continuous nerve catheter will result in lower subjective~     pain scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.~   "
36103|NCT02584439|"~     The conduit arteries exhibit a viscoelastic behavior. Visco-elasticity is partially~     regulated by endothelium and contributes to the optimization of the heart-vessel coupling.~     Aging or high resting heart rate (HR) could alter visco-elastic properties leading to~     increase stiffness of the conduit arteries, an independent cardiovascular risk factor, and~     degradation of heart-vessel coupling. Lowering HR with ivabradine could reduce these~     effects.~      The objective of this study is to assess the effect of HR reduction by repeated~     administration of ivabradine on visco-elastic properties, vascular geometry and function of~     common carotid artery, and on cardiovascular hemodynamic in healthy subject. The influence~     of aging on ivabradine effects are studied too.~      30 healthy volunteers aged between 25 and 65 years old, with a HR ≥ 70 bpm, will receive~     ivabradine or placebo during 8 days in a single center, randomized, cross-group, double~     blinded, placebo-controlled study. Each period of treatment will be separate by 12 to 16~     days of wash-out. Each subject will participate in an exploration visit, including~     evaluation of visco-elastic properties, vascular geometry and function of common carotid~     artery, and cardiovascular hemodynamic, before and after ivabradine or placebo taking.~   "
36104|NCT02584426|"~     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is~     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of~     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since~     being injured. Despite the increasing attention and emphasis on prevention, PUs still~     represent a major health risk for persons with SCI. PUs and other skin breakdowns are at~     risk for becoming infected; it is not uncommon for many different types of bugs to be~     found in the wound. It has been assumed that the presence of these organisms did not impede~     wound healing or skin graft survival. The current proposal will use a new type of procedure~     that involves the direct injection of an antibiotic (in saline) into the skin beneath the~     wound; it is then distributed throughout the wound using a second device that uses sound~     waves. The study will determine if the antibiotic treatment and the standard of care~     improves the rate wound closure compared to the standard of care alone in persons with SCI~     and a chronic pelvic-region PU.~   "
36182|NCT02583399|"~     The primary objective of this study is to evaluate the pharmacokinetic profile of a single~     dose of intravenous ibuprofen administered over approximately ten (10) minutes.~   "
36106|NCT02584400|"~     Regulation of tissue oxygen homeostasis is critical for cell function, proliferation and~     survival. Evidence for this continues to accumulate along with our understanding of the~     complex oxygen-sensing pathways present within cells. Several pathophysiological disorders~     are associated with a loss in oxygen homeostasis, including heart disease, stroke, and~     cancer. The microenvironment of tumors in particular is very oxygen heterogeneous, with~     hypoxic areas which may explain our difficulty treating cancer effectively. Prostate~     carcinomas are known to be hypoxic. Increasing levels of hypoxia within prostatic tissue is~     related to increasing clinical stage, patient age and a more aggressive prostate cancer.~     Several researches indicated that hypoxia might also play a role in esophageal cancer. In~     glial brain tumors, hypoxia is correlated with more rapid tumor recurrence and the hypoxic~     burden in newly diagnosed glioblastomas is linked to the biological aggressiveness. In brain~     metastases CA-IX expression (a marker for hypoxia) is correlated to the primary non-small~     cell lung carcinomas. Hypoxia enhances proliferation, angiogenesis, metastasis,~     chemoresistance and radioresistance of hepatocellular carcinoma. The hypoxic markers HIF-1α,~     VEGF, CA-IX and GLUT-1 were all over expressed in colorectal cancer and its liver~     metastases. Based on literature, hypoxia in tumors originating or disseminated to prostate,~     esophagus, brain and rectum cancer will be studied in this trial.~   "
36107|NCT02584387|"~     This study seeks to examine a Virtual Reality Exposure Therapy (VRET) using the 360° Video~     Virtual Reality (VR) technology for the fear of heights and fear of spiders.~   "
36108|NCT02584374|"~     Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to~     diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography~     and two-plane phlebography are able to show compression, not all suspected iliac vein~     compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic~     value, but is far more expensive. In our experience a balloon occlusion test in the common~     iliac vein during phlebography can diagnose iliac vein compression due to the collateral~     network that is visualised. The general consensus is that pelvic collaterals are a sign of~     pathology, though the investigators would like to validate this test by showing that a~     balloon occlusion test in healthy subjects does not identify a collateral network.~   "
36109|NCT02584361|"~     This study investigate weather one type of cochlear implant (CI) surgery (insertion of the~     electrode via paracentesis of the round window (RWA)) leads to less vertigo than another~     type of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or~     cochleostomy. They will be examined with a video head impulse test (vHIT) before and after~     CI surgery to clarify their vestibular function.~   "
36110|NCT02584348|"~     Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric~     contents. It has been previously reported that bedside two-dimensional ultrasonography can~     be a useful tool for anesthesiologists to determine gastric contents and volume in adults~     and children.~      In this prospective study, preoperative qualitative ultrasound assessment of gastric~     contents is performed for each children admitted for emergency surgery, in order to plane in~     case of empty stomach an intravenous or inhalation technique induction rather than an rapid~     sequence induction.~   "
36111|NCT02584335|"~     The purpose of this study is to evaluate if applying a lidocaine topical solution before~     wounds treatment decreases the pain of the procedure in comparison with placebo solution.~   "
36112|NCT02584322|"~     Currently, at the CHUM - Notre-Dame Hospital, there is no standardized patient care pathway~     for patients undergoing Video Assisted Thoracic Surgery (VATS) lobectomy. The investigators~     goal is to implement an Enhanced Recovery Program (ERP) for patient undergoing VATS~     lobectomy.~      The care given to patient prior to the implementation of this protocol was different amongst~     patients and depended on the surgeon's preferences. The implementation of this ERP will~     permit a reproducible and routine management for patients following their surgery.~   "
36113|NCT02584309|"~     The purpose of this research study is to look at whether giving a drug called dexrazoxane~     plus olaratumab with standard of care doxorubicin affects the progression of the disease.~     Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and~     severity of disease of the heart muscle (which can be caused by doxorubicin).~   "
36114|NCT02584296|"~     Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid~     Leukemia~   "
36115|NCT02584283|"~     Rationale: Recent publications report good results of controlled donation after circulatory~     death (DCD) Maastricht category III liver transplantation when strict donor-recipient~     matching is applied and ischemia times are kept to a minimum. However a major concern~     remains the high rate of biliary complications after transplantation of DCD livers.~     Non-anastomotic biliary strictures (NAS) occur in 29% of patients receiving a DCD graft~     whereas the incidence of NAS in recipients of donation after brain death (DBD) liver grafts~     is 11%. NAS are associated with higher morbidity and increased cost of liver~     transplantation. Injury to the biliary epithelium and the peribiliary vascular plexus~     occurring during donor warm ischemia and static cold storage (SCS) has been identified as a~     major risk factor for development of NAS. Machine perfusion has been proposed as an~     alternative strategy for organ preservation, offering the opportunity to improve the quality~     of the organ by providing oxygen to the graft. Experimental studies have shown that~     end-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) helps liver grafts to~     recover from ischemia by restoring mitochondrial function. Moreover, DHOPE has been shown to~     provide better preservation of peribiliary vascular plexus of the bile ducts, which could be~     an important step forward in reducing the incidence of NAS after transplantation.~      Objective: To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS~     within six months after controlled DCD (Maastricht category III) liver transplantation.~      Study design: An international, multicenter, prospective, randomized, controlled,~     interventional, clinical trial with a two parallel arm approach (treatment/control).~      Study population: Adult patients (≥18 yrs old) undergoing a liver transplantation with a~     liver graft procured from a controlled DCD donor (Maastricht category III) with a body~     weight ≥40 kg.~      Intervention: In the intervention group liver grafts will be subjected to two hours of~     hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control~     group donor liver grafts will be preserved in accordance to standard practice by SCS only.~      Main study parameters/endpoints: The incidence and severity of symptomatic NAS as diagnosed~     by an Adjudication committee (who are blinded for the group assignment) by means of magnetic~     resonance cholangiopancreatography (MRCP).~   "
36116|NCT02584270|"~     This study will fill a scientific gap in the current knowledge providing data for evaluation~     of the palatal augmentation prosthesis as a therapeutic modality in a robust scientific~     randomized prospective clinical trial. Positive outcomes from this study have the potential~     to dramatically alter the most common morbidity of oral cancer therapy, namely speech and~     swallowing function in a population of patients with T1/T2 tumors of the tongue who are not~     currently routinely recommended for a palatal augmentation prosthesis.~   "
36117|NCT02584257|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product, using bronchoprovocation (methacholine challenge testing)~     in adult patients with stable mild asthma.~   "
36119|NCT02584231|"~     Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are~     all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment~     resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot~     study performed at our department showed a correlation between weight and plasma~     concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to~     the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics~     (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old.~     Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary~     concentration testing will be evaluated~   "
36120|NCT02584218|"~     This study aims to evaluate, through a controlled clinical randomized study, the~     effectiveness of sealing carious lesions with composite resin in primary molars. For this,~     healthy children (n=100) with caries lesion reaching to the middle third of the dentin of~     primary molars, will be submitted to different treatments to remove the lesions. These~     patients will be randomly allocated in the following treatment groups: (1) cavity sealing~     (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries~     removal and Invasive resin based restoration. The clinical and radiographic success of the~     treatment groups will be verified by periodic examination of the restorations by USPHS~     criteria and radiographic subtraction, respectively, which will be checked progression or~     not of injury. The researcher responsible for these assessments will be blind to the study,~     whose evaluations will occur after 6, 12, 24 and 36 months of treatment.~   "
36121|NCT02584205|"~     Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect~     functional capacity due to the weakness of the respiratory muscles. Therefore, the objective~     of this study is to evaluate the effect of inspiratory muscle training on functional~     capacity in patients with OSA. A pilot study will be conducted to calculate the sample.~     Individuals of both genders, diagnosed with obstructive sleep apnea moderate or severe~     (measured by polysomnography) will be invited and the data collected in the Sleep Laboratory~     of the Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL.~     The study deals with a test-clinical randomized double-blind.The intervention groups held~     inspiratory muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory~     pressure (MIP). The evaluations will be performed once a week during twelve weeks. Control~     groups will be submitted to a simulated training with load less than 10% of MIP~     (insufficient charge to train the muscles), during the same period as the intervention~     group. The guidelines for the training and weekly evaluations will be performed by the~     responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy~     Laboratory (LACAP- UFPE). After the training period, the groups will be reassessed by the~     evaluation tests of functional capacity (ADL- Glittre Test and Ergospirometry), inspiratory~     muscle strength (manometer) and lung function (spirometry) and then compared. Expected~     results: The interventional groups will improve their functional capacity.~   "
36122|NCT02584192|"~     The purpose of this study was to evaluate the effect of this CR program on the improvement~     of myocardial function using the three-dimensional speckle tracking echocardiography~     (3D-STE) in AMI patients.~   "
36123|NCT02584179|"~     Prostate Cancer (PCa) is the most common male cancer in Denmark and the number is~     increasing. Annually, about 1,600 men are referred to the Department of Urology, Herlev~     Gentofte Hospital, due to elevated PSA (Prostate Specific Antigen) or clinical symptoms~     suspicious of PCa. In approximately 50% of these patients, PCa is diagnosed based on~     histopathological findings in tissue obtained from transrectal ultrasound biopsy (TRUS-bx).~     The TRUS-bx is taken from 10 standard zones in the prostate. If PCa lesions are visualized~     on TRUS, they should appear hypo-echoic compared to the normal peripheral zone. But more~     than 40-50% of the cancerous lesions are iso-echoic and thus difficult to identify.~     Furthermore, benign prostate hyperplasia (BPH) in the transitional zone makes it difficult~     to locate tumours. Therefore, there is a risk of missing a significant cancer or an~     incorrect grading of the tumors aggressiveness (Gleason score) by TRUS-bx. Thus, 10~     systematic biopsies are not always representative of the whole gland. In addition, many men~     only harbour small in-significant cancer foci, that will never cause patient morbidity or~     mortality. It is often best not to detect these small insignificant tumour foci due to the~     risk of overtreatment.~      If MRI was performed before any decision to biopsy was made, some patients might not be~     diagnosed with insignificant PCa since MRI mainly finds significant cancers. The~     Multiparametric Magnetic Resonance Imaging (mp-MRI) seems to be more accurate in detection~     and localization of PCa according to clinical studies and several studies have shown that~     mp-MRI is able to distinguish between patients with significant and insignificant PCa. As~     mp-MRI visualizes the whole gland it can identify suspicious cancerous regions and be used~     as a guide for targeted biopsies. Also, this has the potential to decrease the number of~     biopsies as the 10 standard biopsies can be replaced by 1-4 MRI targeted biopsies.~     Furthermore, some patients might not need biopsies at all if the MRI does not show any~     suspect foci, thereby decreasing the risk of complications from the biopsy-procedure.~      In theory mp-MRI could be used to determine which patients need to be biopsied and which do~     not - a sort of screening tool. The current standard examination takes about 45-60 minutes.~     This is too long and too costly for a screening procedure. Based on the investigators three~     year long experience, they have chosen two scanning sequences and one calculated sequence,~     which they believe can answer the question: Is significant cancer present or not? This is~     the biparametric-MRI (bp-MRI) which takes only 20-25 minutes and does not involve~     administrating any MRI standard drugs. The chosen sequences are: T2-weighted (T2W) images in~     the axial plane, diffusion weighted (DWI) axial images with multiple b-values and~     calculation of the apparent diffusion coefficient (ADC)-map. If, on the other hand, if MRI~     is to be used for staging purpose, six sequences are needed: T2W images in 3 planes (axial,~     coronal and sagittal), DWI axial images with multiple b-values plus calculation of apparent~     diffusion coefficient (ADC)-map and Dynamic Contrast Enhancement (DCE) T1-weighted (T1W).~     This is called a multiparametric MRI (mp-MRI).~      The two T2W sequences in the coronal and sagittal planes can be left out because they mainly~     add information for staging purposes. The hypothesis is that these two are not necessary, as~     the investigators only want to determine whether there is sign of significant cancer or not.~     Neither is the DCE using contrast medium necessary because it only indicates whether~     post-biopsy-blood is present or not which is not the case in this patient group. The bp-MRI~     will be less detailed, but most details are not important when using MRI for PCa detection~     only. Studies show that the ADC-map calculated from DWI correlates with the Gleason score~     and may be used as a non-invasive measure for cancer aggressiveness.~      In summary, the bp-MRI is designed only to determine whether significant cancer is present~     or not, and will not be able to assess the stage of the cancer (extension through the~     capsule or invasion into the vesiculae seminalis or urethra/bladder neck). As previously~     stated, half of the patients that are referred due to suspicion of PCa do not have PCa and~     there is no need for them to undergo the normal mp-MRI scan. In case of a high-risk patient~     (>cT2b, Gleason score >7 and PSA >20 (group 2)) staging is necessary and because of that a~     normal mp-MRI will be performed.~   "
36124|NCT02584166|"~     This cluster-randomised controlled trial will test the hypothesis that a multifaceted~     program with psychological intervention in morbidity mortality conferences (MMC) improve~     care quality and reduce the rate of morbidity mortality perinatal in diverse obstetric care~     settings.~   "
36125|NCT02584153|"~     Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts~     are primarily focused on improving repair materials and surgical techniques to correct these~     hernias instead of the optimal solution: prevention.~      A product called MYOSEAL is currently being developed to prevent hernia formation after~     abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically~     enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study~     is to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure~     in patients undergoing abdominal surgery. The investigators expect that applying this~     product to sutured myofascial incisions will increase collagen formation in the wound and~     thus prevent the formation of incisional hernias.~   "
36126|NCT02584140|"~     The purpose of this study is to test a program that uses drug level monitoring, text~     messaging (iTAB) and personalized counseling with HIV prevention services, including PrEP~     (medicine that can help prevent HIV infection when taken daily).~   "
36127|NCT02584127|"~     The study evaluates the effectiveness of an internet-based smoking cessation program for~     Korean Americans.~   "
36128|NCT02584114|"~     Background: People with psychosis show profound deficits in memory. A new cognitive~     remediation therapy using an app on a computer or mobile phone to improve memory has been~     effective in this population, but the neurobiological effects are unknown.~      Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes~     during a working memory task before and after a 12 hour memory training intervention on a~     computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter~     connecting prefrontal and parietal lobe before and after training.~      Methods: 46 people with psychosis will be randomized to a computerized training of either~     memory training or a control condition of non-memory games (language/card games) and will~     self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total).~     Memory training will be done with the Peak app http://www.peak.net. Imaging data will be~     gathered with a 3 Tesla scanner pre and post training.~   "
36142|NCT02583932|"~     To test whether the Meaning-Making intervention (MMi)(Lee, 2004) plus usual care increases~     the sense of meaning in life in people newly diagnosed with any type of advanced cancer,~     compared to similar people who receive 1) usual care alone or 2) usual care plus visits from~     an empathic visitor, at 2 months after randomization to one of these treatments. The~     investigators will also evaluate whether any effect is present at 4 and 6 months~     post-randomization, and the MMi's impact on anxiety/depression, quality of life, existential~     wellbeing, and posttraumatic growth. To answer our research questions 471 newly diagnosed~     (<6 months) advanced cancer patients (stages III or IV) will be studied.~   "
36143|NCT02583919|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     ISIS-GCGRRx in combination with metformin versus placebo~   "
36129|NCT02584101|"~     Background: Research has extensively documented the adverse impact that caring for an~     individual with an acquired brain injury can have including financial difficulties, social~     isolation, family tension and conflict, relationship difficulties, role adjustment and~     psychological distress (Foster et al., 2012). Research has indicated that Acceptance and~     Commitment Therapy (ACT) shows promise for increasing wellbeing and psychological~     flexibility in caregivers and could be a useful intervention for use with this population.~      Aims: The primary aim of this study is to investigate the feasibility of using an ACT~     intervention to enhance the wellbeing and the psychological flexibility of carers using the~     Population, Intervention, Control, and Outcomes (PICO) framework. Methods: The current study~     is a randomised control design, exploring the feasibility of comparing the efficacy of an~     ACT intervention to Enhanced Treatment As Usual (ETAU), to improve the wellbeing of the~     carers of adults with an acquired brain injury (ABI). Participants will be recruited from~     the Brain Injury Rehabilitation Trust (BIRT) in Glasgow, Scotland and randomly assigned to~     either an ACT intervention group or TAU control group. Both will be assessed in parallel to~     one another completing a range of baseline and post-baseline measures. Applications: This~     feasibility study will provide information for further research on the utilisation of an ACT~     intervention to improve the wellbeing of carers and whether this is an acceptable~     intervention for this population.~   "
36130|NCT02584088|"~     -  The study primarily aims to evaluate the post ablative endometrium and uterus using~          transvaginal ultrasound to provide descriptive information as to what may be expected~          in the 12 months after a NovaSure ablation. Investigators believe this knowledge will~          help them to determine when to proceed with further evaluation postoperatively or when~          to counsel patients on expectant management based on ultrasonographic findings.~        -  Secondary aims include correlation of ultrasonographic findings to demographic patient~          data.~   "
36131|NCT02584075|"~     Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular~     disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell~     located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin~     release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and~     prevent vascular from atherosclerosis. Investigators design this study to investigate~     exenatide's effect on the improvement of the coronary endothelial function by evaluating~     endothelium dependent diastolic function and testing the vascular endothelial active~     substance and related inflammatory factors.~   "
36132|NCT02584062|"~     The purpose of this study is to observe the technologic application of no-touch fluid-air~     exchange in Surgery of Idiopathic Macula Hole.~   "
36133|NCT02584049|"~     The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management~     of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric.~      The investigators assume that the application of a procedure based on osteopathic fascial~     techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from~     pain of nursing care, could reduce the painful phenomenon having systemic action, and~     improve tissue engineering, trophicity viscera and the neurovascular supply .~   "
36134|NCT02584036|"~     The primary objective of this study is to evaluate how implementing an innovative care model~     that provides the pharmacist access to a patient's vaccine history at the point-of-care~     impacts the pharmacist's ability to identify unmet vaccination needs and increase~     vaccination rates for routinely recommended adult vaccinations.~   "
36135|NCT02584023|"~     Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be~     beneficial in mechanically ventilated infants compared to those who did not receive lung~     ultrasound and alveolar recruitment maneuver.~   "
36136|NCT02584010|"~     This study aims to determine if a silicon-based gel and a silicon-based aerosol are~     effective in the treatment of postoperative scars.~   "
36137|NCT02583997|"~     The main objective of this study is to evaluate postoperative pain (measured by visual~     analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom~     teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a~     similar group of patients undergoing standard care (suturing for lower alveoli).~   "
36138|NCT02583984|"~     Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and~     mortality after lung resection. One-lung ventilation (OLV) is usually required in thoracic~     surgery. OLV is also an important predictor of postoperative ALI. Recent laboratory findings~     suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs~     during OLV is the major cause of lung injury. Exhaled Breath Condensate (EBC), which is the~     exhalate from breath typically collected by cooling device, contains most molecules found in~     the airway. Metabolomics refers to systematic and scientific study of chemical processes~     involving metabolites. This study will collect EBC for metabolomic analysis and aim to~     elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms~     of acute lung injury following thoracic surgery.~   "
36139|NCT02583971|"~     Investigators will assess the impact of treatments for atrial fibrillation on participant's~     thrombotic status~   "
36140|NCT02583958|"~     Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local~     treatment of venous or mixed leg ulcers: a European, randomised clinical trial.~   "
36141|NCT02583945|"~     Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in~     patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes~     (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A~     protocol for the improvement of the hemodynamic situation and a standardized proceeding in~     hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement~     of creatinine and urine output, as well as normoglycemia. The primary goal is to determine~     if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of~     AKI in patients at risk after non-cardiac surgery.~   "
36144|NCT02583906|"~     Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH~     (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension)~     patients suffering from sleep disordered breathing.~   "
36183|NCT02583386|"~     The purpose of this study is to examine whether an exercise and educational classroom~     program can help reduce falls in people with Multiple Sclerosis who fall frequently.~   "
36145|NCT02583893|"~     This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow~     samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone~     hydrochloride, etoposide, and cytarabine [MEC]) in patients with acute myeloid leukemia~     (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the~     pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help~     improve patient response. Studying samples of bone marrow from patients treated with~     sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off~     that pathway and whether changes in biomarker levels can predict how well patients will~     respond to treatment.~   "
36146|NCT02583880|"~     This is a survey which will be performed on a specific day (the Screening Day) in Latin~     American ICUs.~      In eligible patients who receive enteral or parenteral nutrition a retrospective calculation~     of the caloric deficit will be performed. The caloric deficit is the difference between~     energy target of each patient and actually administered calories.~   "
36147|NCT02583867|"~     50 subjects with Major Depressive Disorder who are not currently receiving treatment will be~     enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.~   "
36148|NCT02583854|"~     The transradial route is used in 90% of the coronary angiograms performed at Oslo University~     Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to~     achieve hemostasis. Patients and staff will benefit from using a device that yields safe and~     painless hemostasis.~      Patients will be randomly assigned to receive either the standard compression device~     (control group, A) or a recently developed compression device (experimental group, B). The~     study will be designed as a non-inferiority, prospective randomized controlled trial, with~     outcome measures being patient comfort during compression time and complication rates.~     Complications that will be measured are radial artery occlusion (RAO) measured using~     ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after~     application of the compression device will also be classified as complications.~      The aim of the study is to investigate whether the new device, RY-STOP is non-inferior~     compared to the standard device, when considering the outcome measures.~   "
36149|NCT02583841|"~     Aim:~      To evaluate effect of non- surgical periodontal therapy on liver function in systemically~     healthy chronic periodontitis (CP) subjects.~      Materials and methods:~      The study is non surgical interventional trial, includes 50 CP subjects in the age group of~     35- 60 years selected from the OPD (Out Patient Department) of department of periodontology~     Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were~     equally divided into test group and control group. Liver function test- aspartate~     aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1~     month after treatment. Clinical examination includes plaque index, gingival index, sulcus~     bleeding index, probing depth, clinical attachment loss.~   "
36150|NCT02583828|"~     This is a randomized clinical trial to investigate the efficacy of letrozole combined with~     metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.~   "
36151|NCT02583815|"~     This is an open label feasibility pilot study of commercially available physical activity~     monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer~     Center, UT Southwestern Medical Center.~   "
36152|NCT02583802|"~     This clinical study is to observe the improvement of MHD (maintenance hemodialysis)~     patients, quality of life，after applying therapy combining Auriculotherapy and Shengmai~     capsule. As a compliment to each other, Traditional Chinese Medicine and Modern Medicine~     form a joint and help improving life quality of MHD patients. Through the therapy, MHD~     patients, symptoms of thirst are improved, the incidence of intradialytic hypotension is~     reduced, the intake of water and sodium is lessen and the weight gain during dialysis is~     controlled, which consequently reduce cardiovascular and cerebrovascular complications and~     eventually reduce the mortality of MHD patients. Aiming to improve patients, thirst symptom~     and reduce the incidence of intradialytic hypotension, this study prospectively followed 144~     MHD patients using multicenter prospective randomized crossover controlled clinical studies,~     using KT/V, URR, improvement of thirst, blood pressure and cognitive assessment as~     observational index. Multiple questionnaire surveys are conducted to understand patients,~     life quality from different angle. The use of Auriculotherapy is simple and effective and~     Shengmai capsule conforms to patients, syndrome, which is consistent with TCMs principle of~     syndrome differentiation and treatmentand the theory of preventive treatment. The study~     not only expends the use of TMC in hemodialysis treatment, but also suggests a set of easy~     therapeutic schedules to improve the quality of life in patients receiving hemodialysis~     treatment.~   "
36153|NCT02583789|"~     This study represents the first trial to assess the efficacy of oral treprostinil therapy in~     patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to~     vasodilatory therapy.~      The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all~     subjects will be randomized to receive oral treprostinil sustained release tablets or~     matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed~     for 12 weeks of treatment with oral UT-15C during the study.~   "
36154|NCT02583776|"~     Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes~     in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by~     capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes~     in preterm newborns.~      The investigators aim to assess if a continuous glucose monitor (CGM) can be used to~     maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI.~      It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within~     48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4~     Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to~     CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be~     active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily~     capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be~     evaluated with the validated Premature Infant Pain Profile (PIPP) scale.~      The estimated numerosity is 50 patients (25 for each arm).~   "
36155|NCT02583763|"~     The aim is to increase awareness of the relationship between (IUGR) and cardiac function in~     the foetus, the development of cardiac function over time after delivery and what~     significance a possible early disturbed myocardial function have for the neonate and the~     child during the first years of life.~   "
36157|NCT02583737|"~     Bone resorption and atrophy in maxillary posterior region is due to severe periodontal~     disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth~     extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a~     great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's~     and many biomaterials have been used to solve filling issues to maintain the sinus floor~     lifted in a position that can allow dental implants installation. Bone grafts have shown to~     be the best choice of filling grafts. Despite autologous bone are the gold standard filling~     biomaterial it is associates with great mortality and morbidity. So, bone allografts from~     tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue~     bone are the most common allografts but literature is poor in randomized controlled parallel~     clinical trials regarding those filling grafts for sinus lifting. The aim of this study is~     to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized~     and freeze bone allografts from human bone tissue bank. The investigators want to verify~     which one can develop greater osteogenesis, if is there any difference between them~     regarding the architectural trabeculae formation, if there are different patterns of~     reabsorption and finally if is there any differences between them regarding primary and~     lately dental implants stability. To answer those questions the investigators propose~     firstly, to carry out microtomographic and histological analysis from trephine bone samples~     after six months of sinus lifting and grafting in healthy participants undergoing~     osseointegrated dental implants. Secondly, the primary and lately implant stability is going~     to be achieved employing Resonance Frequency Analysis (RFA).~   "
36158|NCT02583711|"~     This is an observational study, which aims to assess how physical activity levels following~     surgical procedures correlate with patient recovery and length of hospital stay, as well as~     the utility of this physical activity data to the postoperative surgical team. Surgical~     teams frequently enquire about their patients' physical activity levels on postoperative~     ward rounds. Although this information is often provided anecdotally by nursing staff and~     junior doctors, there are no objective data made available to the clinician. Such data has~     the potential to supplement other observations (e.g. heart rate, blood pressure,~     temperature) to help gain an impression of a patient's recovery and physical status, this in~     turn could provide evidence to help facilitate early discharge as well as to predict medium~     to longterm outcomes. Advances in wearable technology allow the investigators to collect~     detailed information with regard to activity with minimal disruption.~      Recent literature has shown that these wristworn sensors can feasibly be worn in hospital~     pre and postoperatively, with evidence of a correlation between the amount of steps taken~     postoperatively and the length of hospital stay. This study will provide further evidence~     for the usability and utility of wearable sensors in the inpatient surgical setting. It will~     provide supporting evidence for surgeons to confidently analyse and assess patients in~     hospital, allowing for safe and expedient discharge home as well as identify highrisk~     patients who are likely to require extra support and surveillance in the community setting.~   "
36159|NCT02583698|"~     250 Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) >~     12 mmHg + No/small esophageal varices who present to the Department of Hepatology at~     Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide~     informed consent.~   "
36160|NCT02583685|"~     This is a prospective, randomized study to evaluate the efficacy and safety of switching~     treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese~     with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.~   "
36161|NCT02583672|"~     The purpose of this study is to measure levels of blood and brain chemicals related to~     oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher~     disease (GD1) to see if these levels are altered by GD1.~   "
36162|NCT02583659|"~     This prospective cohort study aims to observe the efficacy and safety of the first-line~     combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.~   "
36163|NCT02583646|"~     Background:~      Studies suggest that overweight girls may be developing breast tissue, and therefore~     starting puberty, earlier than normal weight girls. However, it is hard to distinguish~     breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among~     other tests, they can do a better job of telling whether an overweight girl has breast~     tissue. This will help them understand if overweight girls are truly entering puberty before~     normal weight girls.~      Objective:~      To find out if overweight girls go through puberty earlier than normal weight girls.~      Eligibility:~      Healthy girls 8-14 years old who:~      Are normal weight or overweight~      Have some breast development~      Have not started their first period~      Design:~      Parents of participants will be screened over the phone.~      Most participants will have 1 visit. However, they can choose to have multiple visits within~     4 weeks. The visit will include:~      Physical exam that includes examination of the breasts and genital area~      Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It~     uses sound~      waves to create a picture of the breast tissue.~      Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower~     belly. It uses sound~      waves to create a picture of the ovaries.~      Urine and blood test~      A special x-ray called a DXA to measure the amount of fat in the body: The participant will~     lie still on a~      table while the x-ray takes pictures of the body.~      X-ray of the hand: The picture will tell researchers how mature the participant s bones are.~      Participants may be asked to come back 6 months later to repeat these tests.~   "
36164|NCT02583633|"~     One of the important complications of pregnancy is preterm labor (PTL) and delivery. There~     are different tocolytic agents to enhance the time of delivery. The aim of this study was to~     compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral~     nifedipine for managing preterm labor. This was a randomized clinical trial in women~     admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two~     have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as~     well as gestation age at the time of delivery have been monitored and evaluated in both~     groups of patient. Our main goal has been delay of delivery to have the most beneficial~     effect of primary corticosteroid administration for fetus.~   "
36232|NCT02582749|"~     Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to~     this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or~     ADT with Radium-223 dichloride respectively.~   "
36165|NCT02583620|"~     Compelling evidence of genetic components in high myopia has been put forward by several~     studies. Twin cohorts, familial linkage studies and population studies has described at~     least 10 loci containing genes involved in the disease development. The investigators~     previously demonstrated novel linkage on chromosome 7q36 and chromosome 7p15 in French~     families. A new approach consisting of a case-control based population association study is~     underway in order to recover a high number of myopic subjects avoiding the limitation of~     familial cases. 1.8 millions polymorphic markers will be compared with emmetropic controls~     in order to recover loci associated with the disease in the population.~   "
36166|NCT02583607|"~     Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the~     most sophisticated methods of breast reconstruction is using of autologous fat grafting.~     Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final~     results of fat grafting.~   "
36167|NCT02583594|"~     Primary Objective:~        -  To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab~          administered by subcutaneous injection and 2 treatment courses of alemtuzumab~          administered by intravenous infusion in patients with progressive multiple sclerosis.~      Secondary Objectives:~        -  To characterize the pharmacokinetic profiles of alemtuzumab administered by~          subcutaneous injection or intravenous infusion to patients with progressive multiple~          sclerosis.~        -  To characterize the safety and tolerability of alemtuzumab administered by subcutaneous~          injection or intravenous infusion to patients with progressive multiple sclerosis.~   "
36168|NCT02583581|"~     This study evaluates the use of brain activity monitoring for prediction of migraine attacks~     in an expected time scale of 12-48 hours prior to the migraine attack.~   "
36169|NCT02583568|"~     A need for further investigation for fluorescence image-guided surgery in breast conserving~     surgery (BCS) has arisen following the results obtained from a phase I feasibility breast~     cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the~     optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation~     of breast cancer tissue using the improved and optimized fluorescent tracer and camera~     system.~   "
36170|NCT02583555|"~     The purpose of this study is to identify persons with high risk of frequent hospital~     admissions and by counselling by one in depth interview followed by frequent telephone~     contacts improve their quality of life and reduce their healthcare utilization.~   "
36171|NCT02583542|"~     Selumetinib (AZD6244) and AZD2014 are two new anti-cancer treatments that AstraZeneca are~     developing; they are both not yet approved for clinical use.~      Selumetinib (AZD6244) is a drug that acts by blocking a protein called MEK, which has been~     linked to the development and growth of multiple cancers. AZD2014 is a drug that blocks a~     protein called mTOR that is involved in the growth and spread of cancer. Blocking the action~     of either MEK or mTOR alone may slow down or stop the cancer growing. Combining both drugs~     may make the cancer more sensitive than if Selumetinib (AZD6244) or AZD2014 are used alone~     and therefore this dual treatment may lead to increased anti-tumour effects.~      Although Selumetinib (AZD6244) and AZD2014 given alone and in combination with other~     anti-cancer drugs have been tested in people with advanced cancer, the specific combination~     of Selumetinib (AZD6244) and AZD2014 has not been used in people before. Therefore Phase 1b~     (Dose Escalation Phase) will determine what the recommended dose to use in Phase IIa (Dose~     Expansion Phase) will be. Efficacy, progression free survival, duration of response, and~     overall survival, will then be assessed in patients with triple-negative breast cancer, and~     Non small cell lung cancer within Phase IIa.~   "
36172|NCT02583529|"~     Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's~     disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by~     urgency with or without urge incontinence , usually with frequency and nocturia . The aim of~     this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients~     with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation~     (PTNE).~   "
36173|NCT02583516|"~     The purpose of this study is to evaluate the efficacy and safety of two different schedules~     of administration of vemurafenib in combination with cobimetinib (continuous and~     intermittent) in previously untreated BRAFV600- mutation positive patients with unresectable~     locally advanced or metastatic melanoma.~   "
36174|NCT02583503|"~     When carrying out a knee replacement operation one of the goals is to correct any deformity~     of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is~     a line from the centre of the hip joint to the centre of the ankle. This line indicates how~     the weight of the body is transmitted to the ground via the leg. Often the planning for a~     knee replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the~     mechanical axis can be drawn on.~      However, the weight of the body goes to the ground from the ankle through the heel. There~     have been some reports recently suggesting that deformities in the heel can influence the~     overall leg alignment after a knee replacement; this may affect how successful the surgery~     is, or how long the knee replacement will last. Therefore it may make sense to take the~     alignment of the leg including the heel in planning for a knee replacement.~      The conventional practice to assess the alignment of the heel is a hindfoot alignment view~     (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation~     exposure and makes linking the two alignments very difficult. We propose a single novel Xray~     extending the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement~     of both alignments.~      This study is to validate the hindfoot alignment seen on the novel Xray with the standard~     HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH~     and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be~     compared with the standard HAV to see if it is accurate.~   "
36175|NCT02583490|"~     This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse~     Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional~     unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality.~     The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia~     Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible~     participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP~     ECT, or conventional RUL ECT.~   "
36176|NCT02583477|"~     A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different~     Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma~   "
36184|NCT02583373|"~     The objectives of this study are to assess the safety, tolerability, clinical and~     microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused~     by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of~     standard of care antibiotic treatment.~   "
36185|NCT02583360|"~     The purpose of the investigator's study is to evaluate the causes of feeding difficulty in~     infants. New treatments can be possible only if the cause is known. In this study, the~     investigator plans to evaluate the movement of the muscles in an infant's mouth, throat~     (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the~     stomach and that help protect an infants airway.~   "
36186|NCT02583347|"~     Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is~     reported in up to 50% of patients treated with hemodialysis compared to 12% of a control~     population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been~     described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD~     have also been reported to have a very high prevalence of sleep apnoea disorder.~     Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders~     in patients with CKD.~      Nocturnal hemodialysis (NHD) has recently been developed to dramatically improve biochemical~     control of uremia in patients with ESKD. There is now convincing clinical and~     epidemiological evidence that NHD provides superior clinical and survival outcomes when~     compared to conventional dialysis. Many centers now offer NHD to patients as the premier~     treatment of kidney failure when live or deceased kidney transplantation is not available.~     Regimens for NHD vary between centers - in the investigators' programme NHD patients are~     encouraged to perform eight hours of HD (utilizing the VIVIA system) on 2 of every 3 nights.~     By so doing, patients receive an average of five nights of dialysis per week and receive~     forty hours of dialysis treatment.~      Initial anecdotal experience in the first programme participants suggests that, despite the~     need for caution when the patient is asleep, patients sleep much better overall while~     getting NHD then they do while on conventional HD. Furthermore, a dramatic improvement in~     restless leg syndrome in patients who undertake NHD has been noted.~      The investigators propose a prospective study in which twenty patients commencing NHD will~     undergo a formal polysomnogram study in their home prior to switching to NHD. This will be~     followed by two overnight polysomnogram studies within one month of NHD initiation and will~     be on two consecutive nights - one during which they perform NHD and one on a dialysis-free~     night. A further two overnight polysomnogram studies (under similar conditions) will take~     place six months after commencing NHD.~      Participants will also complete a number of surveys of perceived sleep quality. In this~     study the investigators will identify the impact of NHD on sleep quality.~   "
36187|NCT02583334|"~     Fibromyalgia is the second most common autoimmune rheumatic diseases with clinical~     manifestations of widespread pain, fatigue and accompanied cognitive and emotional~     disturbances. It often associated with sleep disorders and headaches. The cardinal symptom~     of fibromyalgia is widespread pain. Clinical observations reveal that pain in patients with~     fibromyalgia could not simply improve by using analgesics only. Patients often use Chinese~     medicine or acupuncture to help them to ease the pain.~      The aim of this study is to investigate the efficacy of acupuncture in patients with~     fibromyalgia. The study adapted a randomized, assessor- and participant-blinded,~     sham-controlled, and parallel-design approach to investigate whether acupuncture can improve~     the clinical symptoms and quality of life as well as the mechanism through laboratory~     biochemistric and image study.~   "
36188|NCT02583321|"~     Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in~     patients under mechanical ventilation could be questionable. Whatever the hypothetical~     mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated~     Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the~     cornerstone of this potential side effect of the routine oral care with chlorhexidine~     gluconate. The DEMETER study assessing the medico-economical impact of the subglottic~     secretions drainage study (NCT02515617) provides the opportunity to perform this proof of~     concept study (detection of chlorhexidine in tracheal secretions after routine oral care~     with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion~     drainage on this potential detection of chlorhexidine.~      This ancillary study will be performed in one of the centers participating to the DEMETER~     study.~   "
36189|NCT02583308|"~     Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD)~     to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the~     diagnosis of VAP is widely considered as subjective and prone to both false-positive and~     false negative assignments. In ths way, the impact of SSD remains controversial and its use~     limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of~     the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate~     the dynamics of tracheal colonisation with and without the realisation of SSD. This~     evaluation would reinforce the results observed during the DEMETER study in considering the~     adjudicated VAP incidence.~      This ancillary study will be performed in 14 centers participating to the DEMETER study~   "
36190|NCT02583295|"~     Awareness during anesthesia with intraoperative memory occurs when the patient is able to~     process information and produce specific responses to several stimuli. Anecdotal evidence~     suggests that children exposed to therapeutic suggestion consisting of gently encouraging,~     positive words spoken to them during emergence from anesthesia seem to arouse after surgery~     with less agitation, less pain and lower requirements for pain medications. Therapeutic~     suggestion has been associated with positive results in some adults during surgery, but it~     is unknown how therapeutic suggestion affects children. A newborn's recognition and~     preference for their mother's voice occurs early in life, very likely during fetal~     development. Additional evidence, revealed that at least as early as 4 months of age,~     infants process auditory stimuli from their mother's voice at a higher amplitude than they~     process auditory input from female strangers, suggesting that maternal voice stimuli undergo~     a unique form of cerebral processing that lends support for the existence of~     neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice.~     This study aims to evaluate and compare the possibility of intra-operative awareness~     prevention by using either music listening or maternal sound listening in children~     undergoing cardiac surgery.~   "
36191|NCT02583282|"~     Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently~     heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell~     carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion.~     Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for~     the management of MPE. According to a recent survey, tetracycline or its derivative~     (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a~     previous study from the investigators' center, the investigators have demonstrated equal~     efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also,~     iodopovidone has been postulated to have anti-neoplastic effects and hence may help in~     reducing the drain output. Apart from these benefits iodopovidone is easily available and is~     cost effective. The investigators believe that iodopovidone will have better efficacy than~     doxycycline in inducing pleurodesis in malignant pleural effusion.~   "
36192|NCT02583269|"~     This phase I trial studies the side effects and the best dose of muscadine grape skin~     extract (MGE) in treating patients with malignancy (tumor or cancer) that has spread to~     other parts of the body or cannot be removed by surgery. MGE is a nutritional supplement~     containing an extract of the skin of muscadine grape that has shown anti-cancer activity in~     laboratory studies and may be able to fight or kill malignant cells.~   "
36193|NCT02583256|"~     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine~     Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in~     Trial V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.~   "
36194|NCT02583243|"~     Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services~     Administration (SAMHSA) to increase treatment to opiate dependent patients with mental~     illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care~     for as long as the individual takes buprenorphine to track the success of buprenorphine for~     the maintenance of opiate dependence.~   "
36195|NCT02583230|"~     The goal of this project is to develop and pilot a mobile smartphone delivered intervention~     that will improve antidepressant medication care by providing medication adherence~     monitoring and support to the patient, feedback on patient adherence and response to~     treatment to the primary care team, and information to both patients and providers on~     guideline-congruent care personalized to the patient's response to antidepressant~     medication.~   "
36196|NCT02583217|"~     Laryngeal mask airway is a common tool for airway management during anesthesia in many~     surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile~     hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to~     compare the insertion conditions of laryngeal mask by using ketamine+propofol versus~     remifentanil + propofol.~   "
36197|NCT02583204|"~     The study compares three strategies to prevent/minimise nail problems occuring in women,~     with breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail~     polish and normal care; application of Onicolife drops and normal care and; normal care~     only.~   "
36198|NCT02583191|"~     The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the~     treatment of VTE in cancer patients in comparison to the standard treatment with low~     molecular weight heparin (LMWH).~      Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised~     to receive either Rivaroxaban or the standard treatment with low-molecular heparin.~   "
36199|NCT02583178|"~     The purpose of this study is to assess the safety and function of the Aegis Sentinel~     Ligation System in accessing and closing off the left atrial appendage (LAA) using a~     minimally invasive epicardial access approach.~      A minimum of 30 participants will be included in this study, which is being performed at a~     maximum of 8 centers in Canada and the United States. (A maximum of 5 participants at 2 US~     centers will be enrolled)~      Participants will be considered for this treatment if their doctor(s) have determined they~     have documented non-valvular atrial fibrillation and are at increased risk for developing a~     stroke.~   "
36200|NCT02583165|"~     To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced~     solid tumors~   "
36201|NCT02583152|"~     Mucopolysaccharidoses (MPS) are currently treated with Enzyme replacement therapy and Bone~     Marrow Transplantation (BMT). No current evidence on the effectiveness on these therapies on~     the eye in this systemic disease is avalible. Using new imaging techniques; previously~     subjective data can be quantified and compared to determine if there is an improvment in the~     vision of patients with MPS.~   "
36202|NCT02583139|"~     The purpose of this study is to determine whether a specially-designed music-narratives are~     effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.~   "
36203|NCT02583126|"~     The purpose of this study is to determine whether a modified and resource-oriented form of~     Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in~     teenagers with cancer.~   "
36204|NCT02583113|"~     To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA)~     vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis~     who underwent a primary TKA one side and a primary UKA on the opposite side and are at a~     minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along~     with all retrospective chart data.~   "
36205|NCT02583100|"~     This is a pilot study to determine if an audit and feedback intervention decreases~     complication rates after cleft palate surgery.~   "
36206|NCT02583087|"~     This study assesses the quality of the resection of early neoplasia arinsing in Barrett's~     esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry~     among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm~     or more in size treated by endoscopic submucosal dissection.~   "
36207|NCT02583074|"~     Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin~     injections.This study is to establish whether subthalamic nucleus neurostimulation could~     improve symptoms in patients not adequately responding to chemodenervation or oral drug~     treatment. Investigators compared this surgical treatment with sham stimulation in a~     randomized, controlled clinical trial.~   "
36208|NCT02583061|"~     In this prospective observational cohort study, women representing the full spectrum of~     gestational glucose tolerance status are undergoing longitudinal cardiometabolic~     characterization at regular intervals in the years after the index pregnancy.~   "
36209|NCT02583048|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the~     anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in~     combination, among participants (with or without HIV co-infection) taking multidrug~     treatment for multidrug-resistant tuberculosis (MDR-TB).~   "
36233|NCT02582736|"~     The purpose of this study is to determine whether the use of atypical antipsychotic~     medication increases the risk of hospitalization for a hyperglycemic emergency.~      The investigators will carry out separate population-based cohort studies using~     administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry~     will be defined by the initiation of a new antipsychotic medication. Follow-up will continue~     until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from~     the separate sites will be combined to provide an overall assessment of the risk of~     hyperglycemic emergencies among new users of various antipsychotic drugs.~   "
36210|NCT02583035|"~     There are no recommendations and few studies on the monitoring of fragile patients in the~     oncological treatment, both on the organizational arrangements on its interest in the~     prevention of functional deterioration of the patient and adaptation of the potential cancer~     treatment.~      The oncogériatrique evaluation being time-consuming, requiring the movement of these more or~     less frail elderly patients, it seems difficult to envisage repeated and systematic~     standardized geriatric assessments during cancer treatment. Geriatric fragility can be~     detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse~     in patients treated for cancer, but with the aim to detect toxicities of cancer treatment,~     patients are not very old (mean age 64.8 years).~      External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric~     oncology) not knowing the patients included avoids bias of subjectivity in the~     interrogation.~      However the telephone monitoring, with the aim to evaluate the evolution of geriatric~     frailty, has not been specifically studied in the elderly population treated for cancer,~     while taking oncology load.~      The investigators wish to study the feasibility and validity of telephone follow-up which~     could eventually be used routinely to identify patients requiring further medical~     consultation oncogériatrique.~   "
36211|NCT02583022|"~     The study is a Phase II, single center, randomized, open-label, placebo-controlled study in~     male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All~     subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream~     for up to 4 weeks.~   "
36212|NCT02583009|"~     This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic~     confirmatory clinical study by evaluating the safety and therapeutic equivalence of~     PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.~   "
36213|NCT02582996|"~     National clinical trials, phase III, randomized, open, parallel, study of superiority, in~     which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65~     years will be randomly allocated to one of two treatment groups. The Group 01 will use~     Cefalium® and group 02 will use Tylenol®.~   "
36214|NCT02582983|"~     This study assessed the safety and tolerability of enfuvirtide in participants with advanced~     HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens~     containing at least one product from each anti-retroviral class, or had experienced~     intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg)~     subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment~     limiting toxicities and participants benefited from study treatment as per investigator's~     discretion. The anticipated time on study treatment was based on the commercial availability~     of enfuvirtide in Thailand, and the target sample size was 30 individuals.~   "
36215|NCT02582970|"~     This expanded access study will assess the efficacy and safety of intravenous (IV)~     bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic~     cancer of the colon or rectum. The anticipated time on study treatment is approximately 10~     months, and the target sample size is 40 individuals.~   "
36216|NCT02582957|"~     A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive~     mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease~     the number of days they require invasive mechanical ventilation.~   "
36217|NCT02582944|"~     Despite technological advancements directed towards the diagnosis of peripheral pulmonary~     lesions, an optimal approach has yet to be designed. The potential advantages of catheter~     based techniques include the ability to utilize instruments smaller than the diameter of a~     conventional bronchoscope, thereby allowing better access to the lung periphery. The~     drawbacks of a catheter based approach include the relative inability to steer a~     conventional catheter, and the inability to perform direct visualization and airway~     inspection through a conventional catheter. This study will evaluate a novel steerable~     catheter system with optical capabilities and pair this with electromagnetic navigation~     bronchoscopy to biopsy peripheral pulmonary lesions.~   "
36218|NCT02582931|"~     The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of~     delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic~     body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel,~     integrated Co-60 MRI treatment machine. To best assess this technology, the investigators~     will focus on patients that have no more than three sites of progressive disease within the~     central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and~     gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two~     weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the~     current standard of care but will allow adaptation based on daily anatomic changes. The~     prescription dose will be determined based on hard normal tissue constraints, and capped at~     10Gy per fraction. Although the long term goal will be to achieve improved local control and~     disease-free survival with reduced toxicity, the present study will be driven by the short~     term goal of demonstrating the feasibility of this novel treatment approach for recurrent or~     metastatic ovarian cancer.~   "
36219|NCT02582918|"~     Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic~     randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer~     (HCC) surveillance process completion among a socioeconomically and racially diverse cohort~     of Texans with cirrhosis. Through this project the investigators will implement and evaluate~     system-level mailed outreach interventions to identity at-risk patients with cirrhosis,~     promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW)~     Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs~     (VA) Medical Center. The study population will include adult patients with documented or~     unrecognized cirrhosis and at least one outpatient clinic visit in year prior to~     randomization. Patients will be identified using an EMR-enabled case identification~     algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this~     algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or,~     mailed HCC surveillance outreach with patient education and patient navigation services~     (Group 2).~   "
36262|NCT02582359|"~     This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in~     combination with standard therapy for acute myeloid leukemia (AML) consisting of~     daunorubicin and cytarabine as a possible treatment for the patient AML.~   "
36220|NCT02582905|"~     Preclinical and clinical data as well as mechanistic justification have been presented~     suggesting citicoline and pregnenolone are each promising treatments for alcohol use in BPD.~     Both appear to have favorable side effect profiles and no known drug-drug interactions.~     Thus, they have the potential to be safely used in a dual diagnosis population already~     taking other medications. A 12-week, randomized, double-blind, parallel-group,~     placebo-controlled adaptive design study of citicoline and pregnenolone is proposed in 199~     persons with alcohol use disorder and bipolar I or II disorder, mood state currently~     depressed. The primary aim will be to assess change in alcohol use. Biomarkers of alcohol~     use, alcohol craving, mood and cognition will also be assessed. Relationships between~     neurosteroid and choline levels and the outcome measures will be explored.~   "
36221|NCT02582892|"~     Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation~     and remodeling.~   "
36222|NCT02582879|"~     The purpose of the InformCLL Registry is to characterize and describe treatment patterns for~     those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other~     approved anti-CLL /SLL therapies/regimens. This study also evaluates association of~     treatment patterns with patient characteristics, healthcare resource utilization and patient~     reported Health related Quality of Life (HRQoL).~   "
36223|NCT02582866|"~     Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in~     patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of~     additional monotherapy safety data, and will facilitate access to treatment until commercial~     availability for monotherapy use.~   "
36224|NCT02582853|"~     Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP)~     that often is triggered by an infection. GBS is characterized by progressing weakness and~     numbness and loss of tendon of reflexes. It can also include tingling sensation in the legs~     and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in~     demyelination.~      The diagnosis is given by electrophysiological examination and clinical presentation.~      GBS is treated with intravenous immunoglobulin (IVIG) and plasma exchange (PE). Both~     treatments are equally effective. Most patients recover completely, while others must ease~     symptoms and reduce the duration of illness by several treatments.~      The purpose of this study is to define if patients with GBS have higher concentrations of~     sCD163 in their cerebrospinal fluid and serum compared with symptomatic control subjects.~     Furthermore it is to define if the concentrations of sCD163 reduces after treatment.~   "
36225|NCT02582840|"~     This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will~     enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate~     glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit.~     lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3~     single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user~     are excluded.~   "
36226|NCT02582827|"~     The primary objective of study CA601.2 is to determine the maximum tolerated dose (MTD) or~     recommended phase 2 dose (RP2D) of ABI-011 when administered by intravenous (IV) infusion on~     Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor~     malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The~     secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma~     pharmacokinetics (PK), to assess the biological activity and pharmacodynamics, and to make a~     preliminary assessment of tumor response in patients with advanced solid tumors or~     lymphomas. The exploratory objectives are to determine the genomic and proteomic profile of~     patients' tumors to identify gene mutations, gene amplifications, levels of protein~     expression, and pinpoint oncoproteins. Correlations between genomic/proteomic profiles and~     efficacy outcomes will be assessed and principal metabolites of ABI-011 will be determined,~     if possible.~      Approximately 45-60 patients will be treated to determine dose limiting toxicities (DLTs),~     the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up~     to 10 patients) will occur.~   "
36227|NCT02582814|"~     This study will enroll eligible subjects into a long-term safety study (Part B).~      Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic~     control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of~     enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3~     months prior to the screening visit. The study design of Part B is a randomized, open-label,~     2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1~     ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.~   "
36228|NCT02582801|"~     18F-Alfatide Ⅱ PET/CT in breast cancer patients~   "
36229|NCT02582788|"~     The current clinical guidelines for management of atopic dermatitis now recommend bleach~     baths. This requires simply the addition of regular household bleach to twice-weekly baths.~     At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet~     wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has~     not been widely adopted in the pediatric dermatology community. Will the use of dilute~     acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric~     patients as well as, or better than, the current accepted guidelines?~   "
36230|NCT02582775|"~     This is a single-institution, phase II study to determine the event-free survival at 1 year~     post allogeneic transplant and serial mesenchymal stem cell (MSC) infusions from a related~     donor (HLA identical, mismatched or haploidentical) or matched unrelated donor for the~     biochemical correction of severe epidermolysis bullosa (EB).~   "
36231|NCT02582762|"~     Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which~     cause nail plates grow defectively. Common nail surface abnormalities are pitting nails,~     longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail~     surface abnormalities as well.~      Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic~     use is increasing with day by day, their usefulness in conditions such as nail biting,~     brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported~     the benefits of nail gels in terms of improving nail surface abnormalities like pitting~     nails, trachyonychia, and onychoschizia.~      This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has~     humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities~     in finger nail surface abnormalities.~   "
36234|NCT02582723|"~     A double-blind, randomised crossover design will be employed with three experimental~     conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low~     protein/high fat creme cheese served at least 7 days apart. After having successfully~     completed screening procedures, eligible participants will be invited for three separate~     test days. The test days should be performed at least 7 days apart; however for logistical~     reasons 4 days can be accepted. On the test days, the products will be provided in a~     randomized order, and subjective appetite ratings will be measured every 30 minutes for the~     following 3 hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours~     following serving of the breakfast meal.~   "
36235|NCT02582710|"~     Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a~     40% decrease in the average concentration of total microparticles (MPs) in the atheromatous~     plaque.~   "
36236|NCT02582697|"~     The purpose of this study is to determine whether accelerated BEP chemotherapy is more~     effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic~     germ cell tumours.~   "
36237|NCT02582684|"~     This study is being done to see if the combination of two anti-HIV medicines, dolutegravir~     (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, will provide a safe,~     effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an~     integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor.~     DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV~     proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of~     HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA)~     recommended regimens along with a third active drug. Since some HIV medicines have side~     effects and are costly, there is interest in whether HIV can be successfully controlled with~     fewer than three HIV drugs.~   "
36238|NCT02582671|"~     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± RBV~     in chronic hepatitis C virus infected participants across Ireland.~   "
36239|NCT02582658|"~     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN +/- Ribavirin (RBV)~     in chronic hepatitis C virus infected participants in Austria.~   "
36240|NCT02582645|"~     In this investigation the investigators would like to find out which of two commonly used~     techniques of management of palatally impacted canines: closed-window (CWT) or open-window~     (OWT), produces more favorable outcome.~   "
36241|NCT02582632|"~     This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and~     dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b~     hepatitis C virus (HCV).~   "
36242|NCT02582619|"~     Spinal cord injury often results in complete or partial loss of functioning of the upper and~     or lower limbs, leading to the affected individual experiencing difficulties in performing~     activities of daily living. This in turn results in reduced participation in social,~     religious, recreational and economic activities (employment). Globally, there is a low~     employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South~     Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However,~     there is no information available on employment amongst PLWSCI in South Africa.~      Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a~     model to be developed and implemented. Data on the current SCI rehabilitation practices~     (with specific reference to vocational rehabilitation); employment status and factors (both~     personal and environmental); barriers and facilitators of employment amongst PLWSCI is~     limited. This information is needed to develop a return to work model for individuals with~     SCI in South Africa.~      In South Africa, a legal framework exists that promotes the employment as well as assistance~     of people with disabilities in the workplace, such as: the Constitution of Republic of South~     Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and~     Prevention of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995;~     Skills Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of~     Employment Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However,~     rehabilitation interventions provided in rehabilitation institutions are mainly medical,~     with limited attempts to prepare those with SCI to return to gainful employment. There is~     therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and~     multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in~     South Africa.~   "
36243|NCT02582606|"~     In this study investigators will compare the health effect of two different meal patterns.~     In one, participants will consume food according to an 'irregular meal pattern' (minimum 3~     meals, maximum 9 meals per day) and in the other 'regular meal pattern' (6 meals per day)~     for two weeks. The energy requirement of the participants will be calculated to maintain~     body weight during the study. Participants will be provided with all the food to be consumed~     during the study.~      Initially, interested individuals will attend a screening visit in which they will complete~     questionnaires on medical health, eating habits and physical activity. Height, weight and~     waist circumference will be measured at this visit. Thereafter, participants will be~     assigned to a 2-week period following one of the two meal-patterns. There will be a 2-week~     period between the two interventions when they will consume their normal diet and at the end~     of this, participants will undertake the next meal pattern. During the two phases~     participants will be asked to wear an armband (which detects movement and measures heat~     loss), to assess their energy expenditure and an interstitial glucose monitoring device will~     be worn for seven days. Before and after each 2-week intervention, participants will come to~     the laboratory for a mixed-meal tolerance test. Blood samples will be obtained before and~     for 3hrs after eating to evaluate the health effects of the meal patterns. Energy~     expenditure will be measured by ventilated-hood indirect calorimetry and the armband device.~     At the end of the 3hr post prandial period, participants will be offered an ad libitum pasta~     lunch and be asked to eat until they feel comfortably full.~      During each of the 2-week periods, participants will be asked to record their food intake~     and record their appetite sensations on specific days.~   "
36244|NCT02582593|"~     Changes in mood and cognition are common in older adulthood. Some studies have suggested~     that transcranial application of near-infrared (NIR) light may have enhancing effects on~     cognitive and mood status in young adults and individuals with traumatic brain injury. This~     effect has not been examined in older adults. This study will involve a randomized~     sham-controlled trial to learn whether NIR stimulation improves cognition and mood in older~     adults, relative to sham treated controls.~   "
36263|NCT02582346|"~     This project aims at assessing two MRI acquisition methods, neurography and tractography,~     for the visualization of pelvic nerves. The goal is to optimize both methods and to test~     them on a pool of volunteers to assess if nerves can be delineated, so as to provide an~     individualized mapping of nerves to surgeons before an intervention and avoid postoperative~     complications.~   "
36245|NCT02582580|"~     Perineal trauma during childbirth is an important etiological factor of various undesirable~     complications to women's health, with emphasis on pelvic floor dysfunction. Thus, methods~     that preserve the perineal integrity have been a challenge to practices among health~     professionals working in the gravid-puerperal cycle assistance. Despite the remarkable~     importance of beneficial effects of pelvic floor preparation prior to vaginal birth on~     prevention of perineal trauma, there are few studies in the literature that point which is~     the best method to be used to reduce the chances of perineal lesions. Therefore, there is~     need for more studies to compare existing methods. The objective this present study is to~     compare the effects of perineal massage, the vaginal dilator and training of the muscles of~     the pelvic floor to prepare the pelvic floor for vaginal birth on perineal integrity of~     primiparous. Primigravidae women are selected over 18 years, from the 32th gestational week~     and wishing to have a vaginal birth. Women will be randomly allocated into 3 groups:~     perineal massage, vaginal dilator and pelvic floor muscles training and should practice the~     technique from the 34th week of pregnancy until the time of delivery. All the women will be~     subject to clinical evaluation, functional assessment of pelvic floor and perineal integrity~     assessment prior to the beginning of the practice of the technique and between 45 and 60~     days after childbirth.~   "
36246|NCT02582567|"~     The main objective of this project is to assess the effects of a novel and supervised~     exercise intervention in overweight pregnant and their newborn.~      Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight~     pregnant interested in participate in the intervention program will be randomly assigned to~     either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group).~     The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic~     profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii)~     physical fitness; iv) objectively measured physical activity and sedentary behaviour; v)~     sleep quality; vi) mental health, quality of life and positive health; vii) haematology and~     biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x)~     bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed~     on an intention-to-treat basis and per protocol.~   "
36247|NCT02582554|"~     Good nutrition is necessary for optimal growth and development in young children. Nutrition~     risk screening can identify those at risk and to refer them for assessment and treatment.~     The NutriSTEP® (Nutrition Risk Screening for Every Preschooler) questionnaires are 17-item,~     community-based, parent-administered questionnaires for identifying nutritional risk in~     toddlers (18-35 months) and preschoolers (3-5 years). Internet versions are available on the~     Dietitians of Canada website as part of a Nutri-eSTEP online tool. NutriSTEP® is mandated~     for use in Ontario and New Brunswick and is also used in other provinces. NutriSTEP® has~     been implemented in Canadian jurisdictions and in research settings. Many health care~     practitioners, mainly registered dietitians, and policy makers, are asking for evidence that~     NutriSTEP® makes a difference and this project is proposed to show that nutrition screening~     with NutriSTEP® with its accompanying nutrition education resources will increase knowledge~     and change nutrition-related practices by parents of preschoolers.~      This research will be a randomized control trial with more than 150 parents/caregivers of~     toddlers and preschoolers. The treatment group will receive screening with the Nutri-eSTEP~     version of NutriSTEP® and will receive the accompanying nutrition education messages and~     links to resources. A control group will receive the screening treatment at the end of a 12~     week intervention. At the beginning and end of the 12 week period, parents/caregivers will~     fill out questionnaires on parental nutrition knowledge and nutrition-related behaviour~     (including attitudes and intentions).~      This will be the first study of nutrition risk screening with NutriSTEP® to determine if the~     screening process, along with its accompanying nutrition education messages makes a~     difference.~   "
36248|NCT02582541|"~     Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct~     obstruction. It delivers a high amount of thermal energy to target tissue and may prolong~     the duration of stent patency. RFA has showed promising results for malignant bile duct~     obstruction and increasing the duration of stent patency. The aim of our study was to~     evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct~     obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of~     self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.~   "
36249|NCT02582528|"~     The primary aim of the project is to test the effectiveness of a cognitive remediation~     treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing~     (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active~     control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups~     will have improvement in cognition at the end of treatment; 2. CRT+MI group will have~     increased treatment adherence and superior improvements in cognition at the end of treatment~     and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3.~     Improved cognition will be associated with improved functional outcome.~   "
36264|NCT02582333|"~     Background:~      Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many~     patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the~     leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral~     therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998,~     and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high~     viral load in a maximum duration of three years. However, there is a significant proportion~     of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and~     hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of~     current knowledge, in what conditions that the NA therapy can be successfully discontinued~     without hepatitis recurrence remain largely unclear. Therefore, this study is designed to~     evaluate the clinical and virological changes of CHB patients after stopping NA therapy, and~     finding the prognostic indicators may be an important basis for stopping NA therapy in CHB~     patients in the future.~      Objectives:~        1. To access the clinical and virological changes after stopping NA therapy~        2. To determine important prognostic indicators for stopping NA therapy~      Methods:~      In this prospective cohort study, the investigators plan to recruit CHB patients who are~     indicated for stopping NA therapy in the outpatient clinics according to the inclusion and~     exclusion criteria of this study, and clinical and virological data will be collected during~     routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed~     according the following data:~        1. Patient characteristics: including age, sex, height, weight, waist circumference,~          history of alcohol drinking, antiviral therapy history, hepatitis history, and drug~          history.~        2. Blood tests: During routine clinic visits and blood tests every 12 weeks or at~          hepatitis flare in the first 2 years after stopping NA therapy, liver function and~          virological status tests will be conducted for analysis.~   "
36317|NCT02581644|"~     The purpose of the study is to determine a) if the implementation of belatacept patient~     alert card (PAC) resulted in effective understanding of key safety messages and b) if the~     degree of understanding of key safety messages is associated with improved clinical and~     safety outcomes.~   "
36250|NCT02582515|"~     Expert reviews and practice parameter papers recommend behavior therapy as a first-line~     intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity.~     Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT)~     are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive~     treatment response. Thus, there is a clear need to identify strategies to improve treatment~     response and/or accelerate therapeutic gains .~      The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both~     extinction and associative learning. Psychosocial treatments relying on these learning~     mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented~     with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of~     HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the~     child CBIT trial for generalizability and comparability, with the addition of DCS~     contraindications as exclusionary criteria. Parents and youth will complete a battery of~     clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric~     conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or~     HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient~     Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to~     provide results in a more timely fashion. As a result of this trial design, the primary~     outcome of this study will focus on the reduction of bothersome tic severity for those~     targeted in treatment rather than global severity reductions.~   "
36251|NCT02582502|"~     The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in~     improving neurological function in patients who are 6 to 36 months post ischemic stroke.~   "
36252|NCT02582489|"~     The proposed research study aims to evaluate the effects of autologous bone marrow aspirate~     concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients~     undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will~     compare patient-reported outcomes, specifically IKDC scores between patients who receive~     BMAC post-meniscectomy and those who receive a saline control injection. The study will also~     compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis~     is that those who receive the autologous BMAC injection after the procedure will have better~     outcomes than those who do not.~   "
36253|NCT02582476|"~     This is a randomised, double-blind, placebo-controlled phase II clinical trial with a~     cross-over design to investigate the efficacy of bumetanide in patients with hypokalemic~     periodic paralysis (HypoPP).~      The aim is to assess the efficacy of bumetanide in reducing severity and duration of a focal~     attack of weakness in a hand muscle.~      Twelve participants will be recruited.~   "
36254|NCT02582463|"~     The purpose of this study is to develop a prediction-tool, the Medicines Optimisation~     Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of~     preventable medication related problems (MRPs). This has the potential to permit pharmacists~     to identify and focus on the small number of patients (approximately 6%) who are likely to~     experience a significant MRP while in hospital.~   "
36255|NCT02582450|"~     Research project for validation of a questionnaire on compliance to treatment in patients~     with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the~     international methodology validation questionnaires: reverse translation, according to~     intersubject patients, psychometric validation and reliability analysis with large sample of~     patients.~   "
36256|NCT02582437|"~     The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for~     maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive~     patients.~   "
36257|NCT02582424|"~     This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.~   "
36258|NCT02582411|"~     Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma~     and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently,~     there is no gold-standard method for the measurement of ocular blood flow available. Laser~     speckle flowgraphy is a promising technique for the two-dimensional assessment of ocular~     blood flow in humans. So far the technique has, however, been only gained widespread use in~     Japan. The experience in Caucasian subjects is very limited. In a Japanese population it was~     shown that mean blur rate, a measure of chorioretinal blood velocity, decreases with age.~     This is of relevance, because an age-related decline in ocular blood flow may partially~     explain the age-dependence of ocular vascular disease. The present study investigates this~     age-dependence in healthy subjects. In addition, the investigators investigate in a~     sub-group of this population whether relative flow volume (RFV), a novel index of blood flow~     in the human retina derived from laser speckle flowgraphy is associated with retinal blood~     flow as assessed with bi-directional Doppler Optical Coherence Tomography (DOCT).~   "
36259|NCT02582398|"~     This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the~     brain between seasonal affective disorder patients and healthy controls using positron~     emission tomography. In addition the investigators aim to demonstrate the impact of light~     therapy on MAO-A distribution.~   "
36260|NCT02582385|"~     The investigators aim at exploring the differential/topographical in-situ expression of~     cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral~     sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from~     autopsied cases. Previous studies from the investigators and other groups showed that~     inflammatory cytokines are implicated in several neurological affections, particularly~     neurodegenerative conditions. However, in-situ cytokine expression has never been studied so~     far in ALS. The investigators wanted to see if these neuro-mediators are involved in the~     neuromolecular chain/cascade underlying ALS.~   "
36261|NCT02582372|"~     Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and~     motor block with prolonged postoperative analgesia without hemodynamic compromise.~      OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine~     spinal anesthesia for lower abdominal surgeries.~      METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) :~     I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients),~     10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg~     intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2~     saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block,~     motor, sedation and peripheral neurological manifestations of toxicity.~   "
36265|NCT02582320|"~     This is a retrospective observational study aimed at describing the characteristics and~     outcome of CLL patients included in the NPP in Italy in a period of time ranging from the~     start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by~     collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be~     observed for at least 12 months from the treatment start.~   "
36266|NCT02582307|"~     There is ample evidence that pain in children is under recognized and under treated. This is~     especially true for acute abdominal pain, a common complaint in the paediatric emergency~     department. Clinicians often fear that analgesia will obscure the diagnosis of a potentially~     surgical condition. As a result, acute abdominal pain goes untreated in many children, as~     there is no standard of care. Hyoscine N-butylbromide (Buscopan) has been used successfully~     in adults and children for pain associated with urinary tract infections and kidney stones~     for over 60 years. However, no study has explored its usefulness in relieving acute~     abdominal pain in children. The objectives of this study are to investigate to what degree~     Buscopan is effective in relieving abdominal pain in children compared to acetaminophen.~   "
36267|NCT02582294|"~     Fabry's disease is a progressive systemic disease X-linked which combines neurological~     (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular~     (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease)~     and cerebral vascular (stroke) symptoms .~      It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the~     alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.~      The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease~     today are of childbearing age and their multidisciplinary care (by neurologists,~     obstetricians and anesthetists) raises several questions.~      About the anesthetic, the question of epidural block is debated in patients with~     neurological diseases and recommendations are not unequivocal.~      Indeed one of the problems of the management in those conditions is the potential worsening~     of the disease because of the anesthetic procedure. In addition, the possibility of an~     antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate~     an epidural block.~      The rate of epidural block achieved in patients with Fabry's disease is not currently known.~     Moreover, only sparse data on pregnancy outcomes in these patients are reported.~   "
36268|NCT02582281|"~     The non touch technique is a modification of the traditional intrauterine device insertion~     technique. It abolishes the use of Allis and uterine sounding.~   "
36269|NCT02582268|"~     A previous trial performed by our research team, in order to reduce the pain associated with~     intrauterine device insertion, compared the novel technique of IUD insertion under the~     guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It~     came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain~     score and time taken for insertion, when compared with the traditional method. In this study~     our researchers aim to abolish the distracting effect of the technician and the TAS probe~     (which might have interfered with previous results).~   "
36270|NCT02582255|"~     A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine~     type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.~   "
36271|NCT02582242|"~     This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of~     thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with~     type 2 diabetes inadequately controlled with basal insulin.~   "
36272|NCT02582229|"~     Surgery is the only effective treatment for morbid obesity and can be divided into~     restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary~     pancreatic deviation and duodenal switch) or a combination of both (RYGBP).~      This later technique is the most common and most effective surgical procedure performed~     worldwide and has been processed to be an effective treatment of morbid obesity and its~     complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery (1,2).~      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.~     Anterior surface plication and greater curvature plication are variations of vertical~     gastric plication that reduce the gastric capacity through infolding of the anterior surface~     or greater curvature of the stomach, respectively. These approaches have been tested, with~     positive results (3,4).~      A transoral or endoluminal approach (ie, a procedure that requires no incision, because~     access is granted through the mouth) offers the potential for additional benefit to the~     patient, because the procedures continue to become more and more minimally invasive.~      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring~     bariatric procedures performed via flexible endoscopy. Although these procedures may not be~     as effective as their surgical counterparts, these less-invasive options may relieve~     patients of the significant risks associated with surgery (5).~   "
36273|NCT02582216|"~     This study has two objectives. First, to introduce a new virtual reality method that~     incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D)~     augmented virtual reality system. Second, to evaluate the efficiency of this new method on a~     convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP,~     plexopathy, stroke) who were not responding adequately to both pharmaceutical management and~     traditional mirror therapy.~   "
36285|NCT02582060|"~     Currently dosing for prophylaxis is not individualized, and the general approach is to use a~     dose of 25-40 units/kg given 3 times per week or every other day. One of the issues with~     weight-based dosing is the possible over-treatment. This is likely due to the fact that~     laboratory tests are not sensitive enough at the low levels to support decision-making. The~     Thromboelastograph (TEG®) and Thromboelastometry (ROTEM®) are coagulation devices, which~     assess the dynamics of clot formation over time and have several characteristics which~     suggest they may provide important information for individualized prophylaxis treatment for~     our patients.~   "
36286|NCT02582047|"~     Previous studies have demonstrated the immunogenicity and safety of the co-administration of~     the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal~     vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct~     comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly~     with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and~     safety of concomitant administration in the elderly subjects.~   "
36274|NCT02582203|"~     The proposed study is a prospective, open-label, randomized, multi-center trial of~     ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk~     for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John~     Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November~     2015 will be evaluated for inclusion. Patients must present with at least 3 of the following~     local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge,~     induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline~     or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study~     drug will follow a randomized list that was previously generated via a computerized random~     mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients~     will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours~     for patients with normal renal function. Patients randomized to vancomycin will receive the~     standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and~     interval adjusted based on creatinine clearance and via institution-specific pharmacy~     protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours.~     Outcomes measured in the Clinically Evaluable patient population include day two or three~     size reduction (percentage) and clinical response at end of therapy or discharge.~   "
36275|NCT02582190|"~     There is substantial evidence linking inflammation to the initiation and perpetuation of AF.~     Although the precise mechanism by which inflammation contributes to the development of AF~     remains unclear, it has been proposed that inflammation may lead to atrial myocarditis~     with subsequent electrical and structural changes involving both atrial myocytes and~     extracellular matrix, leading finally to initiation and maintenance of AF. The high~     incidence of AF in post-operative cardiac surgeries, a state of intense inflammatory~     process, points out this association. Similarly, in non operative AF, inflammation appears~     to play a prominent role in both etiology and maintenance of AF. Indeed an increase of~     inflammatory markers to both paroxysmal and persistent AF was shown by numerous studies.~   "
36276|NCT02582177|"~     To evaluate the superiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64~     mg/g association (Candicort®) cream or ointment versus clotrimazole 10mg and dexamethasone~     acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms~     (erythema, maceration, peeling, blistering / papules / pustules, itching and burning /~     stinging) 06 (± 1) days after onset treatment.~   "
36277|NCT02582164|"~     Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye~     imaging. The purpose of this study is to investigate the use of a novel long-working~     distance swept source (SS) optical coherence tomography imaging system with fixation~     alignment for use first in young adults, older children, and then young children ages 6~     months to 6 years. The investigator's future goal is to obtain important retinal and optic~     nerve information from OCT in clinic in these young children.~   "
36278|NCT02582151|"~     Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency~     incontinence and voiding symptoms due to bladder dysfunction arising from their underlying~     neurologic condition. Current treatment options are effective for some patients, however~     many patients are not optimally managed due to modest efficacy or significant side effects.~     Second line therapies include intravesical onabotulinum toxin, however it is associated with~     a risk of urinary retention, and patients with neurologic disorders often are unable to~     perform self catheterize due to physical limitations. Sacral neuromodulation is associated~     with an undesirably high cost and potential complications in this population. The use of~     transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it~     may have some potential benefits over percutaneous tibial nerve stimulation. While some~     preliminary studies have suggested it may be effective, there are no high quality randomized~     trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate~     the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid~     and reliable patient reported outcome measures, and objective measures of incontinence have~     been included as outcomes.~   "
36279|NCT02582138|"~     The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme~     (physical activity, nutritional counselling/dietary intervention, and information and~     communications technology intervention) compared with a healthy aging lifestyle education~     programme on mobility disability, in non-disabled older people with physical frailty and~     sarcopenia.~   "
36280|NCT02582125|"~     The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects~     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy~     and resistant to a platinum-based chemotherapeutic regimen.~   "
36281|NCT02582112|"~     This prospective, double-blinded, randomized, controlled study was undertaken to evaluate~     whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine~     and transfusion requirement and lower fluid consumption than use of room-temperature fluids~     (22 oC) in cesarean delivery patients undergoing spinal anesthesia.~   "
36282|NCT02582099|"~     Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve~     symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj~     hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have~     been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.~   "
36283|NCT02582086|"~     The aim of this study is to determine the safety and efficacy of a topical natural health~     product in comparison to placebo for the treatment of herpes labialis.~   "
36284|NCT02582073|"~     There is increasing evidence that the effectiveness of allergy immunotherapy to control~     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid~     administered during a single regimen of subcutaneous (SC) injections or of sublingual~     administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four~     injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly~     intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU~     and 18200 SU are being developed to compare with the current dose. The study is designed to~     explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL~     immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA~     (without MPL) and placebo.~   "
36318|NCT02581631|"~     This is a signaling study to assess whether nivolumab in combination with brentuximab~     vedotin is safe and effective in certain subtypes of non-hodgkin lymphomas.~   "
36288|NCT02582021|"~     The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made~     many contributions to the understanding of cardiovascular disease. A milestone acknowledged~     in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in~     women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD).~     While in 1996, CMD was considered an imaging artifact, in 2013, it is a widely accepted as~     a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is~     prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare~     costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new~     cases projected annually placing CMD prevalence, morbidity and costs higher than all female~     reproductive cancers combined.~      Among women with ischemia, preserved ejection fraction and no obstructive CAD, it has been~     observed that there are relatively more new onset heart failure (HF) hospitalizations than~     nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left~     ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection~     fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic~     dysfunction is linked to CMD via a mechanism of augmentation and/or perpetuation by~     cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly~     understood. Mechanistic understanding is critical to HFpEF intervention and guideline~     development.~      The study hypotheses are as follows:~        1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen)~          promote an inflammatory and pro-oxidative state making the microvasculature vulnerable;~        2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system~          activation, endothelial dysfunction, changes in vascular smooth muscle activation,~          spasm) causing repeated episodes of transient ischemia;~        3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of~          cardiomyocyte contractile and microvascular function against ischemic injury;~        4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and~          relaxation impairment resulting in diastolic dysfunction and heart failure with~          preserved ejection fraction (HFpEF).~   "
36289|NCT02582008|"~     This pilot randomized clinical trial studies how well bupropion hydrochloride works compared~     with patient's choice for quitting smoking in patients with squamous cell head and neck~     cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride~     may help patients quit smoking by enhancing central nervous system neurotransmitters~     noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride~     is more effective than patient's choice in helping quit smoking in patients with squamous~     cell head and neck cancer undergoing radiation therapy with or without chemotherapy.~   "
36290|NCT02581995|"~     To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first~     year of treatment with aflibercept according to the EU Label.~   "
36291|NCT02581982|"~     This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients~     with urothelial cancer that has not responded to previous treatment and has spread to other~     places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together~     with pembrolizumab may be an effective treatment for urothelial cancer.~   "
36292|NCT02581969|"~     Following the performance of the POTTER observational study, whose primary objective was to~     collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of~     prevention of bleeding episodes, the present study aims to extend the observation time up to~     10 years, of the same population involved in the previous study.~      The present study has been designed to allow a focus on long term disease-related damage at~     joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics~     impact of the two different treatment regimens.~   "
36293|NCT02581956|"~     Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is~     increasing probably due to the prolonged life expectancy and a variety of environmental~     factors. Fortunately, breast cancer outcome and survival are improving due to early~     detection and new treatment modalities. After making first strides against breast cancer,~     i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a~     series of chemotherapy, which could prolong their survival but almost inevitably downgrade~     their quality of life due to grueling side effects, such as lack of energy and vulnerability~     to infection. Numerous medical interventions have been tried by healthcare providers to~     alleviate these side effects, but some of them are expensive and therefore become another~     burden for the cancer-afflicted patients. Previous studies have already indicated that~     exercise generated long-term benefits to breast cancer survivors, including improved~     physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase~     in both immune function and quality of life. Among a variety of exercises, walking is the~     least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the~     investigators expected that the breast cancer patients undergoing chemotherapy could~     cost-effectively reap some benefit either physically or psychologically.~      Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a~     useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as~     T helper cells, play an assistant role in the immunologic process, such as maturation of B~     cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+)~     T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and~     tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a~     reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a~     widely adopted tool to evaluate patient's individual health status. By means of serial blood~     sample collections and the delivery of SF-36 survey, this study aimed to objectively and~     quantitatively evaluate the effects of aerobic walking on the breast cancer patients~     undergoing chemotherapy.~   "
36294|NCT02581943|"~     This randomized pilot phase II trial studies the effect of pembrolizumab with or without~     carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer~     that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune~     responses in patients with non-small cell lung cancer.~   "
36295|NCT02581930|"~     This phase II trial studies how well ibrutinib works in treating patients with stage IV~     melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
36296|NCT02581917|"~     This research trial studies metabolic changes in blood samples from patients with acute~     myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the~     laboratory may help doctors learn more about cancer and the development of drug resistance.~   "
36297|NCT02581904|"~     The purpose of this study is to determine if the application of a negative pressure dressing~     intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound~     complication rate in high risk patients.~   "
36298|NCT02581891|"~     This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend~     regimen with aflibercept in subjects with nAMD.~   "
36299|NCT02581878|"~     To establish a recommended dose of BAY1862864 Injection and to investigate how the study~     drug acts in the body, on the cancer cells and how safe it is in patients with advanced~     non-Hodgkin's lymphoma (NHL)~   "
36301|NCT02581852|"~     This study compares workability in subjects with seropositive rheumatoid arthritis (RA) in~     the working age with high and low disease activity. Further interest is to clarify the~     influence of frailty, functional ability and muscle strength on workability and to determine~     the effect of disease activity on selected physiological needs (sleep quality, sexual~     functioning). Methods include a physical examination, questionnaires and physical tests.~   "
36302|NCT02581839|"~     Subjects are asked to take part in a clinical research study that tests Eribulin, a new~     drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been~     approved by the Food and Drug Administration (FDA) for use in patients with brain~     metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but~     the effect it may or may not have on brain metastases has not been studied.~   "
36303|NCT02581826|"~     The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in~     a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis,~     it is hoped that the newer agent will improve the quality of life for patients who suffer~     from Premature Ejaculation (PE).~   "
36304|NCT02581813|"~     The purpose of this study is to examine whether increased dairy intake, at the level~     recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve~     body composition and bone turnover over 12 weeks in overweight and obese girls.~   "
36305|NCT02581800|"~     Background: Premature infants and their patents are discharged earlier from hospital and~     sent home in early in-homecare programs. Research regarding the use of health IT is needed~     to say, whether the use of videoconference and Smartphone application is a viable option to~     address the parents need for support in relations to early discharge.~      Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile~     application versus hospital consultations.~      Method: Main study; a randomized controlled intervention study with the hypothesis; parent~     of premature infants who have access to electronic knowledge and participatory guidance~     24-7: increases proportion of exclusive breastfeeding, Improves parent/infant interaction,~     enhances confidence and increases knowledge.~      Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected~     that this project will be an argument in development of care for premature infants and~     telemedicine use in the future~   "
36306|NCT02581787|"~     The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination)~     is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an~     anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative~     radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may~     inhibit radiation side effects and block tumor growth through multiple mechanisms.~     Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy~     (SBRT), is a specialized form of radiation therapy that precisely delivers high dose~     radiation directly to tumors, thus killing tumor cells and minimizing damage to normal~     tissue. Giving fresolimumab with SABR may work better in treating patients with early stage~     non-small cell lung cancer than treating with SABR alone.~   "
36307|NCT02581774|"~     The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies~     complicated with isolated oligohydramnios managed by induction of labor. This prospective~     case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital~     between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women~     with postdate pregnancies who met the inclusion criteria underwent induction of labor with~     dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared~     between two groups.~   "
36308|NCT02581761|"~     A randomized prospective double blind study of misoprostol administration in asymptomatic~     patients with pregnancies of unknown location.~   "
36309|NCT02581748|"~     Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group~     Phase I study to compare PK profiles and to assess the safety and immunogenicity between~     HLX02 and Herceptin® (U.S. and German).~   "
36310|NCT02581735|"~     Research project whose main objective is to evaluate the use of a technology platform~     (uPatient) to register the prophylactic treatment of patients with hemophilia treated in~     different Hematology and Hemotherapy services of several hospitals in Spain.~   "
36311|NCT02581722|"~     A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically~     shift the MC landscape. PrePex is an innovative circumcision device requiring no injected~     anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally~     skilled healthcare professionals rather than surgeons. Two initial studies conducted in~     Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was~     performed by skilled physicians~   "
36312|NCT02581709|"~     The goal of this research study is to test the feasibility of an intervention programme to~     reduce cognitive impairment due to cancer treatment. The investigators want to find out how~     acceptable the intervention and procedures are for cancer patients.~   "
36313|NCT02581696|"~     An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug~     interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers~   "
36314|NCT02581683|"~     Proper analgesia after total knee arthroplasty (TKA) is important for encouraging early~     ambulation, which can facilitate improved patient outcomes and early hospital discharge. For~     pain control after TKA, adductor canal blocks (ACBs) improve upon the gold standard femoral~     nerve blocks (FNBs) since they do not cause as much quadriceps muscle weakening, while~     providing equivalent analgesia. Multimodal analgesia has become commonplace as a method of~     superior pain control with fewer side effects. Magnesium sulfate as an adjuvant to FNB local~     anesthetics can improve pain control after surgery; however, it also prolongs time to~     ambulation. There are no reports on the effect of magnesium sulfate in ACBs on analgesia~     after TKA. Thus the purpose of this randomized, double-blind, controlled trial is to~     determine whether magnesium sulfate given with local anesthetics via ACB can prolong~     analgesia, reduce pain scores and opioid consumption, and increase mobilization in TKA~     patients.~   "
36315|NCT02581670|"~     Investigators designed a phase II study to evaluate safety and efficacy of lung and liver~     stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable~     for surgery, using VMAT RapidArc approach.~   "
36379|NCT02580838|"~     The aim of this study is to determine whether early use of OnabotulinumtoxinA is more~     effective to improve functional outcomes of upper limb in patients with stroke.~   "
36319|NCT02581618|"~     Myocardial injury occurs after percutaneous coronary intervention due to micro emboli,~     ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning~     has been shown to be useful in preventing myocardial injury but it is not suitable to~     perform it especially in ad hoc interventions. In this study the investigators aim is to~     show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial~     injury during percutaneous coronary intervention.~   "
36320|NCT02581605|"~     For participants whose leg bones don't line up properly, extra stress is placed on either~     the inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually,~     this extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that~     side of the knee joint. This problem is particularly common in young athletes and places~     them at risk of early osteoarthritis.~      An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy)~     and hinged open to straighten the leg. This alteration redistributes body-weight more~     equally across the knee joint and is known to be effective in delaying and possibly~     preventing, the progression of knee osteoarthritis- especially in younger and physically~     more active patients in whom a knee replacement is undesirable.~      Currently it is possible to ( accurately) calculate the precise position of the bone cut and~     number of degrees correction required to straighten a leg using digital x-rays and~     three-dimensional CT scans. However there is no method of implementing this pre-operative~     plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto~     unreliable intra-operative measurements as a guide.~      To improve the accuracy of this operation, the investigator propose the use of a custom-made~     'cutting block', tailored for each individual patient and its shape will match the contour~     of the patient's bone to ensure it can only be placed in one position. Pre-cut slots and~     holes will then guide the saw cut and the number of degrees the bone in hinged open, as per~     the pre-operative plan; it functions as an intra-operative template for the surgeon.~      This study will primarily examine whether there is a close match between the planned and~     actual correction of leg deformities when using a patient-matched cutting-block.~   "
36321|NCT02581592|"~     This multiple-center, nonrandomized, open label, parallel group, single dose study will be~     conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh~     Class B) hepatic impairment to evaluate the effect of hepatic impairment on the~     pharmacokinetics (PK) of TD-4208.~   "
36322|NCT02581579|"~     This is a doble-blind, masked, compared with placebo clinical trial in pediatric population~     in contact with tuberculosis with or without tuberculosis infection. This trial aims to~     study the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells~     eight weeks after the first administration, and the global tolerability of the treatment.~      Nyaditum resae® is a preparation in the form of capsules containing heat-killed~     environmental mycobacteria Mycobacterium manresensis. The overall objective of the study is~     the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active~     tuberculosis.~   "
36323|NCT02581566|"~     Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on~     postoperative pain after knee arthroscopy.~   "
36324|NCT02581553|"~     This study will assess relative bioavailability of lesinurad/allopurinol fixed dose~     combination (FDC), its individual components and the effect of food.~   "
36325|NCT02581540|"~     The aim of this observational study is twofold. The primary hypothesis being tested is that~     initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no~     ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI~     score (<2), GRACE <75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against~     HS troponin at the 99th percentile (<15ng/l with nonischaemic changes)- again all scored~     with initial (first tn ) only.~      The second aim is to directly compare the three established methods of risk stratifying~     patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute~     Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the~     era of high sensitivity troponins performs best.~   "
36326|NCT02581527|"~     In this trial, the investigators are assessing whether giving an increased dose of~     rifampicin to patients receiving the standard treatment for tuberculosis is safe and, when~     given for 4 months only, will also result in greater and faster killing of the tubercle~     bacillus in the lungs and result in relapse rates similar to those found in the WHO~     recommended standard 6 month regimen.~   "
36327|NCT02581514|"~     Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is~     frequently encountered in internal medicine.~      Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and~     solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can~     be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are~     extensive and varied.~      The aim of this study is to assess the feasibility of a diagnostic approach based on a~     decision algorithm in a group of patients with eosinophilia.~      We assume that a procedure with a hierarchy of additional tests would increase the frequency~     of diagnosed cases while decreasing the time to diagnosis.~      This procedure defined by an algorithm would even reduce the number of tests necessary to~     reach a diagnosis.~   "
36328|NCT02581501|"~     GAX represents a novel approach to the development of cancer chemotherapy agents in~     pancreatic cancer and is based upon extensive laboratory investigations for the induction of~     apoptosis in pancreatic carcinoma cells.~   "
36329|NCT02581488|"~     This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers~     with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid~     decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing~     silver. After meeting study criteria, participants will be randomly assigned to apply Santyl~     or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the~     end of 6 weeks, participants will be followed for an additional 4 weeks to examine the~     outcome of the study treatment.~   "
36330|NCT02581475|"~     Segmental examination twice of the proximal colon might be helpful to increase adenoma~     detection rate (ADR).~   "
36331|NCT02581462|"~     Previous studies provide a strong theoretical rationale for the conduct of a randomized~     study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with~     FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the~     stomach or GEJ.~   "
36332|NCT02581449|"~     The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on~     pediatric patients undergoing hemodialysis via the measurement of the following before and~     after omega-3 administration:oxidative stress markers, inflammatory markers and serum~     lipids.~   "
36333|NCT02581436|"~     This study evaluates the addition of Kidney Solid Organ Rejection Test (kSORT), in the~     clinical follow-up of renal transplant recipients, compared to clinical standard~     surveillance in the first two years after kidney transplantation. The design of the study is~     a partially blinded, randomized control trial of patients with living and deceased donor.~     The recruitment will be in a third level attention hospital in Mexico city (Instituto~     Nacional de Ciencias Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate~     and grade of acute rejection, histologic chronic index of the one year protocol biopsy and~     glomerular filtration rate.~   "
36334|NCT02581423|"~     This study will evaluate the safety and tolerability of capecitabine (Xeloda) in~     participants who have undergone surgery for colon cancer. Oral Xeloda will be administered~     twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study~     treatment is 24 weeks, and the target sample size is 70 individuals.~   "
36335|NCT02581410|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5~     years earlier.~   "
36336|NCT02581397|"~     This study evaluates the non-inferiority of Suppository Transpulmin and Suppository Guaiacol~     compared to Transpulmin Syrup in the treatment of cough with secretion of infectious origin~     in children between two and six years old. One third of participants will receive~     Suppository Transpulmin, the other one third will receive Suppository Guaiacol and the last~     one third will receive Transpulmin Syrup.~   "
36337|NCT02581384|"~     This research study is studying stereotactic body radiotherapy (SBRT) as a possible~     treatment for lung relapse of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. SBRT is a~     form of targeted radiotherapy that can treat very small tumors using a few large doses.~   "
36338|NCT02581371|"~     The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin~     in combination with standard therapy on the dynamics of recovery of the paretic upper limb~     in patients with acute ischemic stroke.~      Each patient participates in the study for 176-190 days (approximately 6 months). The~     estimated duration of the study is 2 years.~   "
36339|NCT02581358|"~     The purpose of the study is to investigate the validity of Scolioscan for quantitative~     assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.~   "
36340|NCT02581345|"~     The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed~     adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic~     plaque-type psoriasis.~   "
36341|NCT02581332|"~     The purpose of this study is to examine the effects of a brief mindfulness meditation~     intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to~     a wait-list control condition. Based on prior research, investigators' working hypothesis is~     that this intervention will decrease the severity of FM-associated clinical pain and~     experimentally induced pain in comparison to pre-intervention scores and a wait-list control~     group. Additionally, based on prior work, investigators postulate that mindfulness~     meditation training will decrease a) depression, b) state anxiety, c) overall disease~     severity, and d) perceived stress, while increasing e) quality of sleep, and f) mindfulness~     skills in comparison to pre-intervention scores and the wait-list control group.~      Investigators will also be testing if decreases in pain ratings during meditation correspond~     to increases in parasympathetic activity. The relative systemic contributions of the~     parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be~     examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat~     interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart~     rate variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic~     activity. Importantly, decreased HF HRV correlates with increased pain. Investigators~     therefore will employ psychophysical and physiological methodologies to test the hypothesis~     that the analgesic effects of mindfulness meditation in FM patients are associated with~     increases in HF HRV.~   "
36342|NCT02581319|"~     Smoking has been considered the most important risk factor for periodontitis among all~     lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status~     of smokers undergoing periodontal maintenance therapy and controversial results were found.~     This study will evaluate clinical conditions and prevalence of putative periodontopathogens~     and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of~     nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using~     Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession~     (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients~     with chronic periodontitis. Samples of subgingival biofilm will be obtained from the~     periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction~     and Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter~     actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella~     intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and~     Candida dublinienses.~   "
36343|NCT02581306|"~     If eligible to participate in the research study after completing the physical screening~     procedures, participants will be asked to return to the Substrate Metabolism Laboratory on~     another occasion after a short fast (no food or beverages - besides water) for at least 6~     hours. After participants arrive, participants will rest quietly for approximately 30 min.~     The investigators will then collect a blood sample from a vein in participants hand, or~     forearm. After obtaining a baseline blood sample, participants will exercise at a moderate~     intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate~     exercise session will feel like a slow jog during which participants would be able to carry~     a conversation. In order for the investigators to measure energy expended and the amount of~     fat participants are burning during exercise, the investigators will periodically ask~     participants to breathe through a mouthpiece so the investigators can collect participants~     expired breath. After the exercise session the investigators will collect another blood~     sample from a vein in participants hand, or forearm.~   "
36344|NCT02581293|"~     In this study the investigators want to asses the effect of peritonisation at c-section on~     postoperative vital signs which was thought to be an indirect finding secondary to increased~     sympathetic activity originated from pain caused by stretched peritoneum.~   "
36345|NCT02581280|"~     Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of~     oxygen to the body tissues in vitro and to assist in heart and lung function. Venoarterial~     (VA) ECMO is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia~     and is able to secure a time to self-recovery by reducing the excessive stimulation applied~     to the heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as~     increased volume of distribution (Vd) or decreased clearance (CL). For this reason, it is~     hard to provide the best treatment in ECMO patients. The study is to evaluate whether the PK~     of drugs is influenced by VA ECMO and to recommend the optimal dosing strategies for~     proposed drugs in adult patients receiving VA ECMO.~   "
36346|NCT02581267|"~     Psychiatric presentations are common in the emergency department (ED), and determining~     whether or not a psychiatric presentation is due to medical illness can be a difficult task~     for the emergency physician. The investigators define serious medical illness (SMI) as a~     pathological condition that would necessitate inpatient treatment on a medical or surgical~     ward. It is important for patient safety that SMI be triaged by the emergency physician to~     the appropriate inpatient service. The rate of missed SMI in patients with psychiatric~     presentations to the ED is unknown. The investigators will research missed SMI in patients~     referred to adult psychiatry from the ED, with the intent to improve patient safety.~   "
36347|NCT02581254|"~     Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and~     effective technique for removal of diminutive polyps. Both thick and thin wire snares are~     now commonly used for CSP. However, because of their physical characteristics, thick wire~     snares might leave a higher percentage of residual adenoma at the resection site. Since this~     may result in a higher risk of recurrence, the technique needs to be optimized. Experts have~     suggested that a thin wire snare might be more efficient, with a lower risk of residual~     adenoma at the resection site and consequently a lower risk of recurrence and interval~     cancer.~   "
36348|NCT02581241|"~     The drug-induced long QT syndrome (diLQTS) describes a clinical entity in which~     administration of a drug produces marked prolongation of the QT interval of the~     electrocardiogram, associated with the development of a polymorphic ventricular tachycardia,~     termed torsades de pointes (TdP). The heart rate is an important variable affecting the QT~     interval. The QT interval normally shortens as the heart rate accelerates; however, the~     adaptation of the QT interval to sudden heart rate acceleration is not instantaneous.~     Interestingly, Holter studies show that the speed of response of the QT interval to sudden~     changes in heart rate (that is, the time it takes the QT interval of a given person to reach~     a new steady-state QT/RR relation) in healthy persons is highly individual and independent~     of the basic QTc. The investigators and others recently proposed the quick standing test~     as a simple bedside test that facilitates the diagnosis of congenital LQTS. The test takes~     advantage of the fact that as one stands up, the heart rate acceleration is abrupt while the~     associated QT-interval shortening is gradual. As the R-R interval shortens faster than the~     QT interval, the QT appears to stretch toward the next P wave and the corrected QT~     interval (QTc) for heart rate actually increases momentarily. The phenomenon of QT~     stretching is universal but is exaggerated in patients with LQTS, allowing for a simple but~     accurate diagnostic test. There is no data on the effects of quick standing on~     drug-associated form of the long QT syndrome. The investigators therefore propose the~     present study to better understand who these patients with drug-associated form of the long~     QT syndrome are and what the significance of their abnormal QT-response is.~   "
36349|NCT02581228|"~     This is a retrospective, open label study to establish and validate a prediction technology~     for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the~     immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response~     rate and disease progression~   "
36350|NCT02581215|"~     This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the~     efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo~     (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment.~     Both arms will continue treatment until disease progression or unacceptable toxicity.~   "
36351|NCT02581202|"~     This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir~     (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1)~     infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at~     least 6 months) at the 48 week time point of treatment in the routine clinical settings of~     the Russian Federation.~   "
36352|NCT02581189|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported~     outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic~     hepatitis C (CHC) in a real life setting across clinical practice patient populations in~     Canada.~   "
36353|NCT02581176|"~     This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in~     patients with cancer. The current standard treatment of venous thrombosis in cancer patients~     is subcutaneous injections with low molecular weight heparin. During the last 5 years~     several new direct acting oral anticoagulants have been tested out as treatment of venous~     thrombosis. But very few cancer patients were included in the phase III clinical trials of~     the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer~     patients with venous thrombosis will respond to treatment with direct acting oral~     anticoagulants. The current study will investigate the direct acting oral anticoagulant~     apixaban in cancer patients with venous thrombosis.~   "
36354|NCT02581163|"~     This study is to provide evidence of the effectiveness as well as the influence of adherence~     on treatment outcome of Paritaprevir/ritonavir, Ombitasvir, +/- Dasabuvir, (the ABBVIE~     REGIMEN) ± Ribavirin (RBV) in a real world setting of hepatitis C virus infected clinical~     practice populations across Belgium. The study may also help identify predictive factors of~     response that are important in real world treatment settings. In addition, it will provide~     data on the impact of adherence on treatment outcomes in everyday settings, which may help~     treating physicians to improve the management of participants under their care.~   "
36355|NCT02581150|"~     The purpose of this study is to assess the efficiency of outpatient surgery compared to~     conventional hospitalization in endovascular treatment of occlusive arterial disease. A~     cost-utility analysis will be conducted from a societal perspective. Patients referred for~     peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up~     will be performed.~   "
36356|NCT02581137|"~     This phase IIa trial studies how well metformin hydrochloride works in preventing oral~     cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia).~     Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do~     not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may~     help prevent oral cancer from forming in patients with an oral premalignant lesion.~   "
36357|NCT02581124|"~     Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP)~     inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and~     tolerability of JTZ-951 when administered alone and one hour after the administration of~     lapatinib.~   "
36358|NCT02581111|"~     Brain-dead patients who provide authorization for organ donation will be randomized to~     naloxone or placebo if baseline arterial blood gas (ABG, after initiation of OPO management)~     reveals hypoxemia (PF ratio < 300), unless they have already been ruled-out for lung~     recovery. Investigators aim to assess whether naloxone improves oxygenation prior to organ~     recovery more than placebo.~   "
36359|NCT02581098|"~     This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to~     wound healing in diabetic patients and also to determine if ex vivo supplementation of~     miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from~     NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64~     in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to~     support wound healing and will be in the study for 14 weeks that includes 4 study visits.~   "
36360|NCT02581085|"~     The purpose of this Phase IIA trial is to validate the outcome observed in the Phase I trial~     that oral TCT attenuates the rise in MELD over time in patients diagnosed with NAFLD, NASH~     or chronically infected hepatitis C. Subjects will participate for 3 years. They will be~     asked to come to 8 total study visits and will receive 6 follow-up phone calls within the 3~     years of participation. Subjects will be asked to take 2 study capsules of vitamin E~     Tocotrienol (200mg) twice a day or 2 placebo capsules twice a day. The study is randomized~     and study staff will be blinded to randomization.~   "
36361|NCT02581072|"~     The study is a 4 way cross-over study in subjects with moderate to severe acne vulgaris who~     will each receive SB204 4%, a supratherapeutic dose of SB204 (either 8 or 12%),~     moxifloxacillin (positive control) and appropriate placebo to match. SB204 will be applied~     topically to the upper back, upper chest, upper shoulders, and face.~   "
36362|NCT02581059|"~     This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients~     treated with regorafenib to determine if ginseng will reduce fatigue in this patient~     population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and~     randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng~     group and 30 enrolled in the regorafenib + no ginseng group.~   "
36363|NCT02581046|"~     Congenital cataract is an important treatable cause of visual handicap in childhood~     throughout the world. Successful management of childhood cataract is dependent on~     individualized treatment strategies and rigorous postoperative supervision for adverse~     complication. In this trial, we aimed to compare the difference of postoperative outcome~     between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will~     be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6~     month, 9 month, 12 month, 18month and 24month postoperatively.~   "
36364|NCT02581033|"~     Evaluation of the rate of sustained virological response among HBeAg-negativechronic~     hepatitis B patients who discontinue long-term NA therapy.~      During this study participants will cease their prescribed medications, this will occur with~     immediate effect once enrolled into the study. The duration of cessation will be indefinite,~     unless clinically indicated for NA therapy re-start. Participants will be monitored as per~     protocol following cessation, monitoring will be by clinic visit and through blood test to~     monitor virological response. Clinical visits will be at the intervals of week 2, week, 4,~     week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the~     participant will have completed the trial. Once the participant has completed the trial they~     will not commence again, the aim is for an indefinite cessation of NA therapy.~   "
36365|NCT02581020|"~     This study seeks to assess the durability of response and persistence of resistance to~     ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3~     clinical study with these agents for the treatment of chronic hepatitis C.~   "
36366|NCT02581007|"~     This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from~     partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The~     primary objective of the study is to estimate the incidence of graft rejection and acute~     GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS,~     chronic GVHD and EFS.~   "
36367|NCT02580994|"~     This is a multicenter, open-label, two armed, controlled, and randomized phase II trial~     investigating the activity of pembrolizumab (MK-3475) in combination with standard~     chemotherapy in Extensive Disease (ED)-SCLC.~   "
36380|NCT02580825|"~     The purpose of the study is to explore if self biofeedback program can reduce ground~     reaction force (GRF) from the lower extremity of the body and in the knee in particular and~     help obese children to avoid knee injuries.~   "
36381|NCT02580812|"~     The purpose of the study is to determine whether perinatal listeriosis is associated with~     long-term neurological consequences, and to evaluate the respective contribution of~     perinatal sepsis, of prematurity and of the known neurological tropism of the involved~     pathogen, Listeria monocytogenes.~   "
36382|NCT02580799|"~     A multi-center non-interventional, in-vitro trial for evaluation of concordance of the~     results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the~     Immunohistochemical (IHC) method in pathological samples collected from participants with~     breast cancer.~   "
40790|NCT02523092|"~     The objective is this study is to test whether use of Acthar gel in the context of~     sarcoidosis will lead to improved symptoms and lung function and correlate with decreased~     levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).~   "
36368|NCT02580981|"~     Previous work performed by University of New Mexico Comprehensive Cancer Center (UNMCCC)~     investigators has revealed previously unknown genomic mutations in children, adolescents,~     and young adults with high-risk B and T cell precursor acute lymphoblastic leukemia (ALL).~     Using genomic and next generation DNA sequencing technologies, these investigators revealed~     that 14% of children with high-risk ALL have Philadelphia chromosome-like (Ph-like) ALL.~     Patients with this form of ALL were found to have a significantly increased risk of~     treatment failure and death.~      Further work revealed that there are more than 40 distinct gene rearrangements and fusions~     that can result in Ph-like ALL. Cell lines and human leukemic cells expressing some of these~     different gene fusions were sensitive to currently available drugs. This suggests that~     Ph-like ALL patients with these specific distinct gene fusions should be targeted in future~     clinical trials to be treated with appropriate therapy. Further work is also needed to~     identify other potentially targetable genetic alterations in ALL patients.~      Therefore, the goal of this study is to perform genomic screening of all newly diagnosed ALL~     patients seen at UNM and to use this information to enroll patients onto available National~     Clinical Trial Network (NCTN) clinical trials. If an appropriate NCTN trial is not~     available, best clinical management will be pursued.~   "
36369|NCT02580968|"~     A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture~     formula, and to analysis the regulation of the intensity-effects and to observe the~     peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture~     treatment.~   "
36370|NCT02580955|"~     A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon~     dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.~      Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW~     Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal~     lesions (TASC C&D).~   "
36371|NCT02580942|"~     The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases~     in Summer is effective in the treatment of chronic asthma.~   "
36372|NCT02580929|"~     This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk~     relapse hepatocellular cancer patients.~   "
36373|NCT02580916|"~     Background:~      Patient-reported outcome measures (PROMs) provide validated evidence of health and quality~     of life (QoL) from the patient perspective. Several national PROMs programmes have been~     implemented in the National Health Service - specifically for common elective procedures.~     Local implementation is varied across settings and populations. The incidence of~     non-melanoma skin cancer (NMSC) is rapidly increasing, posing considerable burden on UK~     healthcare resources, yet there is limited evidence of use of PROMs in NMSC and little~     information about patients' perceived health and QoL.~      Objectives:~      This study will explore feasibility of implementing a skin cancer-specific PROM - Skin~     Cancer Quality of Life Impact Tool (SCQOLIT) for NMSC.~      Methods:~      Three hundred patients with a pathological diagnosis of NMSC undergoing all treatment~     modalities will be recruited to complete SCQOLIT questionnaires at baseline, at 3, 6 and 9~     months. Participation and response rates, missing data and individual change scores will be~     analysed. Staff and patients will be interviewed to explore acceptability and feasibility of~     collecting PROMs data.~      Results:~      Interim results of the project to date will be presented. Feasibility will be assessed by~     evaluating number of eligible patients, number of consenting patients, reasons for not~     consenting and participant number. Individual longitudinal change in scores, response rates~     and psychometric properties of the SCQOLIT will be reported.~      Implications:~      Acceptability and feasibility of the SCQOLIT tool has never been rigorously assessed in~     Dermatology clinics. A validated NMSC-specific PROM would help standardize multi-centred~     trials, allow robust evaluation of quality of care and more appropriately direct healthcare~     resources to improve QoL in patients with NMSC.~   "
36374|NCT02580903|"~     This is an observational prospective study aiming to clarify the prevalence of pulmonary~     hypertension in patients with Myeloproliferative Neoplasms and their prognosis.~      All patients attending our department with the above mentioned neoplasms will be offered~     inclusion in this study. All will have an echo performed and patients identified as being at~     risk of pulmonary hypertension will be offered complete investigation as specified by the~     European Cardiology Association.~      All patients will be followed up for a total of five years to identify prognosis.~   "
36375|NCT02580890|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).~      Randomized, double-blind Controlled Clinical Trial~      Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria~     and who agree to participate in the study Will recruit from advertisements and clinical~     referrals to a PRODAH~      Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is~     applied for 20 min~      Sham tDCS Same assembly is used Current is applied for 30 sec~      Both groups 5 stimulation sessions on consecutive days~      Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD~     Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression~   "
36376|NCT02580877|"~     The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to~     assess the effects of varying doses and schedules of oral insulin on immunological and~     metabolic markers in relatives at risk for type 1 diabetes (T1D).~   "
36377|NCT02580864|"~     Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's~     disease.~   "
36378|NCT02580851|"~     Current guidelines for the diagnosis and management of patients with stable coronary artery~     disease (CAD) strongly support the performance of non-invasive imaging techniques for the~     detection of myocardial ischemia prior to revascularization procedures. This recommendation~     originates from the strong evidence base showing the lack of prognostic benefit from~     percutaneous coronary interventions (PCI) over optimal medical therapy in patients without~     verification of myocardial ischemia. On the other hand, it could be demonstrated that~     patients with functionally significant coronary artery stenoses do benefit from~     revascularization. Cardiac magnetic resonance imaging (CMR) has emerged to be a diagnostic~     modality of choice for the detection of myocardial ischemia with high sensitivity and~     specificity. The investigators therefore designed this prospective and randomized trial to~     compare a CMR-driven vs. angiography-driven management of patients with stable CAD~     concerning major cardiac endpoints, futile angiographies and quality of life.~   "
36383|NCT02580786|"~     This study examines if the internet-based peer support has an effect on the breastfeeding~     attitude or the duration of breastfeeding in preterm infants and their mothers compared with~     mothers with routine care. The factors associated with the initiation of breastfeeding in~     the neonatal intensive care unit will be determined. In addition, the perceptions of the~     mothers of preterm infants about their needs and problems when breastfeeding their preterm~     infants are described.~   "
36384|NCT02580773|"~     Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD)~     representing the leading cause of death and the second cause of hospitalization among adult~     patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during~     ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via~     the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized,~     double-blind study is to test the efficacy and safety of a curative anticoagulation strategy~     during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint~     is number of major bleedings.~      A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT~     scan is positive (thrombosis within a large elastic artery), the patient will not be~     randomized and will be treated with a curative anticoagulation. If the CT scan is negative,~     the patient will be randomized to receive subcutaneous anticoagulation with low molecular~     weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day~     for 7 days) or at a prophylactic dose (4500 UI/day).~   "
36385|NCT02580760|"~     This cross-sectional monocentric study will describe transgender men transitioning into~     women and who had cosmetic silicone injection.~      The principal objective is to estimate the prevalence of Transgender with circulating~     monocytes containing silicone vacuoles in blood smears among Male to Female Transgender~     population with a history of cosmetic silicon injections.~      The secondary objectives are to describe the transgender population, to describe the~     quantity of silicone in vacuoles of circulating monocytes, and the association between~     dermatological complications (inflammatory and not inflammatory) and several clinical and~     biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome,~     quantity of silicone which was injected , silicone quantity in blood smears).~   "
36386|NCT02580747|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.~   "
36387|NCT02580734|"~     The purpose of this study is to determine whether melatonin is effective in the treatment of~     burning mouth syndrome (BMS).~   "
36388|NCT02580721|"~     Crestal bone and soft tissue stability around implants is an important issue in implant~     dentistry. Initial vertical mucosal tissue thickness was shown to be one of the factors~     having impact on bone stability. However, there is lack of data in the literature regarding~     the relationship between mucosal thickness and marginal bone loss around implants. Berglundh~     and Lindhe in an animal study reported that thin mucosal tissue causes significantly more~     crestal bone resorption around implants. In addition, clinical research regarding the~     effects of tissue thickness on bone and soft tissue stability around implants is lacking.~     The aim of this clinical study is to evaluate the influence of mucosal tissue thickness on~     soft and hard tissue changes around implants.~   "
36389|NCT02580708|"~     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib~     when administered in combination with trametinib.~   "
36390|NCT02580695|"~     Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health~     issue since none of the current therapies are truly disease modifying. The use of~     mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction~     in cartilage degradation, the attenuation of bone sclerosis and an effective~     anti-inflammatory response. Investigators have designed a randomized phase I/II placebo~     controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing~     monodosis versus double intra-articular injection, re-randomized at 6 months.~   "
36391|NCT02580682|"~     To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on allergic rhinitis.~   "
36392|NCT02580669|"~     The goal of this study is to show pattern differences of vasoreactivity and connectivity~     between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the~     use of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these~     differences with Clinical disability and cognitive disorder results.~   "
36393|NCT02580656|"~     Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in~     the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these~     survivors require treatment for clinical levels of emotional distress. The investigators~     will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.~   "
36394|NCT02580643|"~     This study will document treatment effects, changes in quality of life, procedure~     complications, adverse events, healthcare resource utilization, and further needed~     intervention(s) following treatment with nSTRIDE autologous protein solution. This study~     will also allow for the documentation of the same parameters following multiple injections~     of autologous protein solution to treat knee osteoarthritis.~   "
36395|NCT02580630|"~     The purpose of this study is to compare in a randomized double blinded controlled trial the~     effect of heavy slow resistance exercises combined with ultrasound guided injections with~     local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.~   "
36396|NCT02580617|"~     This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn'~     disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived~     mesenchymal stem cells.~   "
36397|NCT02580604|"~     Declines in serum calcium during exercise may cause increases in markers of bone resorption.~     This study will determine if preventing the decline serum ionized calcium experienced at the~     onset of exercise through the use of a calcium clamp also prevents increases in blood~     biomarkers associated with bone resorption.~   "
36398|NCT02580591|"~     The study will investigate the efficacy, safety, tolerability and PK of 3 doses of~     empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes~     mellitus as adjunctive therapy to insulin~   "
36399|NCT02580578|"~     This study will characterize the treatments and outcomes associated with different uterine~     fibroid treatments in Canada, to understand patients' preferences and satisfaction with~     different medical and procedural interventions. The study will also assess the effectiveness~     of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and~     symptoms, and improvement in patient's quality of life.~   "
36400|NCT02580565|"~     The use of analgesics can lead to cases of drug abuse and dependence. It can also cause~     pseudo-addiction in patients suffering from pain. What is the actual situation in patients~     suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive~     crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical~     Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to~     differentiate the symptoms occurring only in a context of pain, in the aim of managing the~     pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no~     pain, and more in favour of true addiction. Currently there is no data available in France~     on this problem, and no studies have been carried out in children or adolescents with~     sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic~     use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a~     population of subjects with severe sickle-cell disease in France.~      PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an~     observational, descriptive and transversal study. Patients under the age of 26 with~     sickle-cell disease are included in the study by the doctors looking after them in~     sickle-cell disease centres. The patients are then contacted by a trained researcher for a~     telephone interview, including an evaluation of the Diagnostic and Statistical Manual of~     Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and~     nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also~     completed using the subject's medical record.~      This study will make it possible to provide an initial quantitative and qualitative~     evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic~     drugs in the sickle-cell disease population. The results will be used firstly to provide~     additional data essential for monitoring the risk of overdose, abuse, dependence and misuse~     of these products, and to begin awareness-raising and to provide information for health care~     professionals, in order to significantly improve the management of sickle-cell~     disease-related pain.~   "
36401|NCT02580552|"~     The primary objective of this study is to evaluate the safety and tolerability of the~     investigational drug, MRG-106, in patients with cutaneous T-cell lymphoma (CTCL), mycosis~     fungoides subtype. MRG-106 is an inhibitor of a molecule called miR-155 that is found at~     high levels in the malignant T-cells of many mycosis fungoides patients. miR-155 may be~     important in promoting the growth and survival of these cancer cells. In Part A of the~     study, MRG-106 will be tested by injection directly into CTCL lesions in the skin. In Part B~     of the study, MRG-106 will be given by subcutaneous injection or by intravenous infusion.~     Other objectives of the study are to measure the absorption and clearance of MRG-106 from~     the blood, and to understand how cells in CTCL skin lesions respond when exposed to MRG-106.~   "
36402|NCT02580539|"~     This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients~     suffering from high EBV viral titers not responding to standard of care therapies and to~     treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells~     or a T cell line derived from the patient's allogeneic donor (in the case of stem cell~     transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or~     partially matched related donor.~   "
36403|NCT02580526|"~     This study compares the effectiveness of two kinds of two-handed facemask ventilation~     techniques (when breathing is supported with machines) at the time that general anesthesia~     is started. Study participants will start with one technique and then cross over to the~     other technique.~   "
36404|NCT02580513|"~     This study will evaluate the effect of circadian misalignment on insulin sensitivity in~     healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the~     research facility for two study periods of 3 and 3.5 days. In one of the study periods, the~     behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a~     hyperinsulinemic euglycemic clamp.~   "
36405|NCT02580500|"~     Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques~     is used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is~     the local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal~     and epidural anesthesia techniques activity, reliability will be compared to the side~     effects and complications.~      One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under~     Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural~     anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal~     anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia~     procedures.All patients has symptomatic pilonidal dermoid cyst.~   "
36406|NCT02580487|"~     Acute appendicitis is the most common illness that brings pediatric patients to the hospital~     for surgical treatment. Abdominal pain is the symptom because of which the patients go to~     the hospital. Some patients have severe pain and need analgesics before the final diagnosis~     and before surgery. After surgery most patient experience pain and at least 80 % of the~     patients need postoperative pain medication. For two decades there has been a clinical~     guideline for pain management in Kuopio University Hospital (KUH). The investigators aim was~     to evaluate how well the pain management for pediatric patient works in clinical practice.~   "
36407|NCT02580474|"~     Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C~     and chronic renal failure will be assessed.~   "
36408|NCT02580461|"~     The RECHARGE study is evaluating the effect of a 24 week structured exercise and education~     program on the physical and emotion health, quality of life, physical activity and fitness~     levels of family caregivers. Very little research has been done examining the impact of a~     structured exercise program designed for family caregivers of cancer patients. The purpose~     of this study is to determine if physical activity is effective in improving caregiver~     health and well-being.~   "
36409|NCT02580448|"~     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics~     and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with advanced~     breast cancer.~   "
36441|NCT02580032|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     validate two measures for growth hormone deficiency in children, the Treatment Related~     Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden~     Measure of Childhood Growth Hormone Deficiency (TB-CGHD).~   "
36442|NCT02580019|"~     The study aims at estimating the safety and efficacy of the intravenous injection of human~     umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in~     recent 3 months.~   "
36443|NCT02580006|"~     This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and~     EPREX after single subcutaneous administration.~   "
36410|NCT02580435|"~     Multiple sclerosis (MS) is an inflammatory disease that affects the nervous system and~     results in a wide range of signs and symptoms including physical and cognitive problems.~     Recent evidence demonstrates that interactions between the host immune system and the~     commensal gut microbiota have a key role in the development of the disease. However, the~     natures of these interactions are poorly studied, and the set of bacteria with pathogenic or~     protective potential are unknown. Here, the investigators propose a multi-pronged approach~     to deciphering the role of the microbiota in MS, by developing microbiome-based machine~     learning algorithms aimed at: (1) distinguishing healthy individuals from MS patients; (2)~     predicting the time since the onset of MS in relation to disease activity by predicting next~     relapse and neurological progression; (3) identifying microbiome signatures that~     characterize the relapse state; (4) distinguishing various MS phenotypes in relation to~     blood and microbiome transcriptome signatures; (5) predicting response to various~     immunomodulatory treatments in relation to blood and microbiome transcriptome signatures.~     Overall, these studies should establish the role of the microbiome in multiple sclerosis,~     resulting in a set of non-invasive tools for characterization of the disease; identification~     of the kinetics of MS using microbiome as a readout; and allowing the prediction of~     individuals prone to MS based on their microbiome and in relation to their protein~     expression. These new set of diagnostic and predictive tools may thus add a novel and~     unexplored dimension to the study of the disease that may lead in the future to new~     therapeutic avenues based on designing microbiome-targeted interventions.~   "
36411|NCT02580422|"~     Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles,~     tolerance to chemotherapy, early toxicity and quality of life; however, its effect on~     cardiopulmonary function is not well understood. Preclinical studies demonstrated~     diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with~     mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a~     generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the~     peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning~     associated with chemotherapy or related to direct effect on cardiac and diaphragmatic~     muscles remains unknown. In this pilot study, the investigators propose to perform a~     preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer,~     who are likely to develop cachexia, to assess for the feasibility of performing a larger~     prospective study to understand the impact of cancer cachexia on cardiopulmonary function.~     This pilot study will provide the foundation to potentially identify cachexia in early~     stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent~     or delay its progression. Based on clinical experience and published literature, it is~     expected that 60-70% of patients will have >10% weight loss during the course of this~     disease. More commonly, this is associated with clinical or radiographic disease~     progression, but certainly it can happen throughout the course of the disease even without~     disease progression.~   "
36412|NCT02580409|"~     Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the~     benefits of a novel rehabilitative care program on physical function utilizing mobile health~     technology to deliver patient centered care more efficiently and health care utilization~     after one year of follow up.~   "
36413|NCT02580396|"~     This feasibility study will be conducted in order to provide proof of concept for the~     CanADVICE+® system comprising a smart phone app and a healthcare organization server side~     application based on Web 2 technologies. The main objective of this project is to optimise~     pharmaceutical counselling services by providing drug related information, in a digital~     format, to patients with metastatic breast cancer receiving Capecitabine.~   "
36414|NCT02580383|"~     The investigators collected data and chart from the patients who were diagnosed facet joint~     syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.~      RF was performed using sensory stimulation and multifidus twitching to confirm the position~     of RF needle. The patients wil be grouped according to the adequacy of RF needle position~     while performing RF medial branch neurotomy ('complete' when all needles were placed~     adequately, 'partial' when one of the needles for a facet joint medial branch was placed~     inadequately, 'none' when there were both needles positioned inadequately for a facet joint)~     The relationship between the long term effect of RF neurotomy (longer than 6 months) and the~     groups will be analyzed.~   "
36415|NCT02580370|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with lateral~     canthal lines.~   "
36416|NCT02580357|"~     The aim of this study was to compare two intensities of LLLT on wound healing process of the~     donor palatine area after CTG removal.~   "
36417|NCT02580344|"~     The Copper intrauterine device is the most common method of reversible contraception~     worldwide. Abnormal uterine bleeding and pain are the most common medical indications for~     the discontinuation of the intrauterine device.~      Excessive prostaglandin release in the endometrial cavity appears to play an important role~     in both bleeding and pain related to copper intrauterine devices.There are many types of~     prostaglandin metabolites that present in the endometrium one of them is prostacyclin which~     causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which~     has two types; A2 which is active and rapidly converted into B2, which is inactive.~     Thromboxane causes vasoconstriction and blood clotting.~      Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors~     acting by decreasing production of endometrial prostaglandins; they can improve both heavy~     uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used~     to treat heavy uterine bleeding and pain associated with copper intrauterine device use such~     as mefenamic acid, ibuprofen and naproxen.~      The most recent systematic review found NSAIDs is the most widely studied drugs for~     reduction of the menstrual blood and pain associated with copper intrauterine device. The~     Cochrane Review also found that NSAIDs are the most effective treatment to reduce the~     bleeding with copper intrauterine device use.~   "
36418|NCT02580331|"~     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance~     osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may~     exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy~     of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP)~     for the treatment of Class II furcation defects in comparison with placebo gel.~   "
36419|NCT02580318|"~     This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In~     a safe environment and after signing informed consent, each participant will consume a~     standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If~     the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic~     beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number~     of alcoholic beverages the subject consumes will be monitored by the observers. When the~     target BAT is reached, the subjects will manipulate the breathalyzer in various ways and~     measure their BAT again after each manipulation. In a set order, the subjects will~     manipulate the breathalyzer by using less than the subject's maximal exhalation effort,~     placing the breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly~     (less than 1 second) and successive breaths prior to using the device), repeating~     breathalyzer 5 minutes and 10 minutes after hyperventilation and then drinking cold water~     after the breathalyzer at 10 minutes and repeating the breathalyzer after drinking some cold~     water. Descriptive statistical analyses as well as Pearson's product moment correlation~     coefficient will be employed to determine if any statistically significant correlation~     exists for any of the manipulations.~   "
36420|NCT02580305|"~     This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,~     parallel group, placebo-controlled study to compare the efficacy and safety of treatment~     with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving~     stable doses of donepezil HCl and memantine HCl.~   "
36421|NCT02580292|"~     To determine if ultrasound measurement of renal and carotid arterial resistive indices are~     associated with post-cardiac surgery acute kidney injury.~   "
36422|NCT02580279|"~     The investigators conduct this phase II study of EGCG therapy protection of the skin from~     damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of~     EGCG, investigators will utilize both clinician assessments and patient self-assessments.~     Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group~     (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment~     Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The~     scales are translated into Chinese and guides in Chinese are developed instructing how to~     use the scales and perform the assessments.~   "
36423|NCT02580266|"~     Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular~     complication of diabetes. New treatments are urgently needed for preventing or slowing down~     the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained~     from patients with diabetes and different degree of renal impairment.~      In this project cells in culture will be treated with plasma or serum or urine; cells~     extracts or supernatant will be studied to screen for modulation (activation/inhibition) of~     different cellular pathways using gene array, metabolomic and/or proteomic. Once some~     cellular pathways have been identified specific analysis will be conducted on the biological~     material collected to confirm specific cell signatures that could represent potential~     target for treatment.~   "
36424|NCT02580253|"~     This study is a randomized, open-label, controlled study that will explore the efficacy of~     individualized adjuvant chemotherapy based on the adenosine triphosphate tumor~     chemosensitivity assay for patients with hepatocellular carcinoma after liver~     transplantation.~   "
36425|NCT02580240|"~     The purpose of this study : 1）to determine whether hydrocortisone is effective in the~     treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone~     administration in septic shock patients.~   "
36426|NCT02580227|"~     The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss~     and need for perioperative blood transfusion following intertrochanteric and subtrochanteric~     femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood~     clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our~     hypothesis is that by providing TXA at the time of hospital admission it will decrease the~     amount of preoperative and intraoperative bleeding thereby leading to a decreased need for~     post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in~     which half of patients will be randomized to receive TXA at the time of hospital admission~     and half of patients will receive a placebo.~   "
36427|NCT02580214|"~     The aim of this pilot study was to investigate whether the use of a multimodal protocol of~     preoperative care plus preoperative immune nutrition would decrease the length of stay and~     acute phase inflammation in patients submitted to total hip arthroplasty (THA). The study~     was designed to be randomized and controlled, but not double blind. The patients were~     randomized to receive either preoperative care based on evidence plus immune nutrition for 5~     days prior to surgery (Acerto group) or traditional preoperative care (control group). Main~     endpoints were length of stay and acute-phase postoperative response~   "
36428|NCT02580201|"~     The purpose of this study is to assess the safety (serious adverse events [SAEs]), and~     severe adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV~     in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and~     immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN~     tOPV in vaccine-naïve infants.~   "
36429|NCT02580188|"~     This study is a randomized, controlled, double-blinded, and parallel design study. A total~     96 patients were randomized to receive a deep block or a moderate block scheduled for~     elective laparoscopic colorectal surgery. Investigators estimated the proportion of~     intra-abdominal pressure(IAP) alarm and surgical rating score.~   "
36444|NCT02579993|"~     In this study the prognostic value of ABCB5 in survival of the limbal stem cell~     transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in~     patients with limbal stem cell deficiency will be analyzed.~   "
36445|NCT02579980|"~     Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators~     cannot tell if the treatment is working or not. In this research program, two techniques~     using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas,~     which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests~     are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow~     visualization of how sarcomas are different from the normal organs of the body. These MRI~     tests will tell us the location of sarcoma and its proximity to other structures, as well as~     correlation of imaging with pathological characteristics after surgery~   "
36430|NCT02580175|"~     The abortion considers the most common cause of fetal demise all over the world. The~     majority of cases occur in the first trimester.The termination of abortion may be by medical~     or surgical methods, however; the surgical methods represents the greater part of~     termination. Therefore, the safety of this procedure is a worldwide public health concern .~     Many clinical studies have been reported the safety of surgical evacuation in the first~     trimester.~      The suction-aspiration or vacuum aspiration are the most common surgical methods of induced~     abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction~     using a manual syringe or electric pump. However; these technique always need cervical~     dilation before aspiration. The menstrual extraction does not require cervical dilation and~     can be used in very early pregnancy.~      The surgical evacuation is generally considered safe, however; short-term complications are~     reported due to need of dilatation of the cervix and incomplete evacuation because the~     surgeon is the only one who can decide the end of the operation depending on his subjective~     sense.~      However; with continuous ultrasound guidance, the process could be almost complete because~     the ultrasound can accurately identify the direction and size of the uterus, position of the~     gestational sac, observe the insertion of surgical instruments and the advancement of the~     operation especially when the configuration of the uterus is distorted.~      At present; ultrasonography is not considered to be an essential pre-requisite for abortion~     in all cases so our study aims to detect if complete evacuation can be achieved by~     ultrasonographic assistance or not. We also tried in this study to compare the operative~     time, amount of blood loss and the occurrence of accidental uterine perforation during the~     procedure with and without use of ultrasound.~   "
36431|NCT02580162|"~     This study evaluates and compares the efficacy of professional versus peer-based delivery of~     family-based treatment for childhood overweight and obesity in elementary school aged~     children. Families will be randomized to receive treatment from professionals or to receive~     treatment from professionally-trained peer interventionists. Some parents will then be~     invited to serve as peer interventionists for the next group of families.~   "
36432|NCT02580149|"~     To investigate if treatment with ticagrelor can mitigate the transient loss of~     endothelium-dependent vasodilatation of the resistance vasculature following a short period~     of ischemia, compared with clopidogrel at standard clinical doses. The effect of ticagrelor~     or clopidogrel will be studied after a loading dose and after a two weeks period of regular~     intake on FBF in response to the vasodilators acetylcholine or nitroglycerin before and 10~     min after a 20 min forearm ischemia, respectively.~   "
36433|NCT02580136|"~     The purpose of this study is to collect and organize data into a repository to gather~     relevant information for future research from patients diagnosed with a rare malignant~     sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal~     skull base surgery. Data being collected includes surgical data, demographics, disease~     presentation, MRI, CT, PET imaging, and post-operative assessments including pathology~     tests. After surgery, the investigators will collect chemotherapy and radiation data.~     Participants will also complete quality of life questionnaires at their follow-up visits.~   "
36434|NCT02580123|"~     The importance of families in the development of infants is well documented. Previous~     studies found that the prevalence of overweight and obesity is growing concerns in Portugal~     (Padez, Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014).~     More, there is evidence that habits acquired in early life might track into adulthood (Lien,~     Lytle, & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug,~     2007). Therefore, there is a need to lock overweight and obesity in early childhood in order~     to contribute to health gains during the entire life cycle. The main purpose of this~     research is to evaluate the impact of an intervention program based on parenting skills and~     feeding practices, on infant's growth, development and adherence to new foods in early~     infancy~      Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized~     trial and were randomly allocated to intervention and control group. Infant outcomes were~     performed at baseline and post-intervention and included anthropometry, dietary assessment~     and temperament. In addition maternal and family outcomes such as anxiety, dietary intake~     were also assessed at both times.~      An intervention program was developed and Implemented according to two terms: educators'~     training with the researchers and the intervention with parents and infants developed by~     trained educators. The training program was developed between December 2013 and February~     2014, according to the topics of healthy eating and nutrition and development of the infant.~     The control group received the standard care.~      It is expected that this intervention program is able to promote healthy feeding practices~     to parents and nursery teachers. The results will be disseminated to the stakeholders and~     policymakers that work closely to the topic of this study. This will include papers'~     publication, participation in national and international meetings, contributing to the~     advance of research in this health area.~   "
36435|NCT02580110|"~     The study intention is to investigate, in healthy humans, effects of 3 commonly used~     sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut~     microbiota composition.~   "
36436|NCT02580097|"~     To explore Magnetic Resonance(MR) perfusion imaging as a biomarker to predict outcome of~     patients with acute and subacute stroke. Contrast bolus perfusion imaging and arterial spin~     labeling were conducted in included patients. Imaging evaluation of hemodynamic status,~     collateral and antegrade flow were assessed. Patients were followed up to record~     radiological and clinical outcome.~   "
36437|NCT02580084|"~     Currently, according to the TASC II consensus document (2007) and the Russian guidelines for~     limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is~     suggested.~   "
36438|NCT02580071|"~     The treatment options for high-risk acute leukemia patients are limited and these patients~     are often opt for hematopoietic stem cell transplant (HSCT). However studies show that~     prognosis following this last-resort therapy is bleak. At times, less than 70% of post-HSCT~     relapsed AML and ALL patients even achieve complete remission; median overall survival of~     these cohorts might not reach one year; and 3-year post-HSCT survival rates might be less~     than 20%.~      The investigators plan to recruit acute leukemia patients from CMUH which are planned to~     receive HSCT, and follow the rate and quality of their immune reconstitution. As~     intervention, part of the patients will receive a Chinese medicine herbal formula, which~     they will take for 6 months.Differences between the 1-year post-HSCT condition of patients~     will be examined.~   "
36439|NCT02580058|"~     A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to~     demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in~     prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian~     cancer.~   "
36440|NCT02580045|"~     This clinical trial is being done to learn more about how different types of cancer~     treatments affect cancer cells when they spread to the brain. Many cancer treatments are not~     able to make their way into the brain or into spinal fluid of the central nervous system.~     This is because they cannot cross what is called the blood-brain barrier or BBB. The BBB~     is like a protective shield that only allows certain materials pass through to reach the~     brain but not others. This study is being initiated to help researchers learn more about~     what types of cancer treatments make it through the BBB to attack cancer cells within the~     brain, and what treatments do not make it through the BBB. Learning more about this may help~     future researchers develop more effective cancer drugs that better fight cancer cells that~     have spread to the brain.~   "
36446|NCT02579967|"~     Background:~      Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood~     or bone marrow and given to another person. Researchers think this may help people with~     immune system problems.~      Objective:~      To see if allogeneic blood or bone marrow transplant is safe and effective in treating~     people with primary immunodeficiencies.~      Eligibility:~      Donors: Healthy people ages 4 or older~      Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with~     allogeneic blood or marrow transplant~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will have urine tests, EKG, and chest x-ray.~      Donors will have:~      Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone.~      OR~      Blood collection: They will have several drug injections over 5 7 days. Blood is taken by IV~     in one arm, circulates through a machine to remove stem cells, and returned by IV in the~     other arm.~      Possible vein assessment or pre-anesthesia evaluation~      Recipients will have:~      Lung test, heart tests, radiology scans, CT scans, and dental exam~      Possible tissue biopsies or lumbar puncture~      Bone marrow and a small piece of bone removed by needle in the hipbone.~      Chemotherapy 1-2 weeks before transplant day~      Donor stem cell donation through a catheter put into a vein in the chest or neck~      Several-week hospital stay. They will take medications and may need blood transfusions and~     additional procedures.~      After discharge, recipients will:~      Remain near the clinic for about 3 months. They will have weekly visits and may require~     hospital readmission.~      Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for~     at least 5 years.~   "
36447|NCT02579954|"~     Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary~     vascular resistance inducing shortness of breath and exercise intolerance. We aim to~     correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to~     exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent~     patients with pulmonary arterial hypertension, and their evolution at three and twelve~     months.~   "
36448|NCT02579941|"~     Pregnancy induces a physiological change of hemostasis to a prothrombotic state : protein S~     decrease and increase of virtually all the clotting factors, in particular fibrinogen, von~     Willebrand factor and factor VIII. However, a state of hyperfibrinolysis may occur in the~     immediate postpartum period (especially after placental delivery), thereby promoting~     postpartum hemorrhage.~      This state of hyperfibrinolysis is associated with the use of transfusions of blood products~     and the realization of hysterectomy.It is currently the most common etiology of maternal~     mortality in childbirth.There is an imperative to develop an efficient and reliable protocol~     for the management of this postpartum complication.~      Tranexamic acid is an anti-fibrinolytic agent (like lysine) which acts by preventing the~     conversion of plasminogen to plasmin, by blocking the binding of plasminogen to the heavy~     chain of fibrin.The optimal dose of tranexamic acid enabling to inhibit fibrinolysis without~     increasing the complications rate remains to be defined. It is in this context that the~     investigators aim to evaluate, in an in-vitro model, the minimum dose of tranexamic acid~     required to inhibit fibrinolysis after activation of the latter by t-PA. The degree of~     fibrinolysis will be evaluated by thromboelastometry.~   "
36449|NCT02579928|"~     The purpose of this study is to determine if Ketamine infusion will result in improvement of~     depressive symptoms in adolescents that have failed at least one trial with a~     pharmacological agent.~   "
36450|NCT02579915|"~     The purpose of the study is to develop a personalized, user-friendly computerized treatment~     for anxiety disorders linked to primary care. The computerized treatment is a type of~     Cognitive Bias Modification, which targets attention and interpretation biases known to~     maintain anxiety disorders.~   "
36451|NCT02579902|"~     The purpose of this study is to determine whether vitamin D3 supplementation is effective in~     the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to~     Irritable Bowel Syndrome (IBS).~   "
36452|NCT02579889|"~     The study is designed as a multi-center, international, prospective, parallel, randomized,~     single blinded trial comparing the time to first primary endpoint event (Sustained~     Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years,~     between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with~     pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND),~     with or without atrioventricular (AV) block.~   "
36453|NCT02579876|"~     This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy~     and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic~     Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.~   "
36454|NCT02579863|"~     The purpose of this study is to compare the efficacy of lenalidomide and low dose~     dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose~     dexamethasone without pembrolizumab in terms of progression-free survival (PFS) in~     participants with newly diagnosed and treatment-naïve multiple myeloma who are ineligible~     for autologous stem cell transplant (Auto-SCT).~   "
36455|NCT02579850|"~     The aim of the present study is to evaluate the superiority of the fixed triple therapy with~     BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler®~     (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD~     patients.~   "
36469|NCT02579668|"~     In the United Kingdom, the language of the Deaf community is British Sign Language (BSL). A~     small proportion of Deaf young people who use BSL as their first or dominant language have~     specific language difficulties and would benefit from language therapy provided in sign~     language by adults who are fluent in BSL and may be Deaf. Some Deaf adults are currently~     employed in education and health services to support children's BSL development. However~     there is little training or information available to these adults about language assessment,~     diagnosis of language difficulties or intervention strategies.~      Recent studies have highlighted language difficulties and therapy in sign as an issues and~     begun to explore Deaf adults understanding of language difficulties and disorder. This~     project aims to extend knowledge in this area by supporting Deaf practitioners to understand~     and develop language therapy skills and co-develop language therapy intervention resources.~     The study will pilot training for practitioners and language therapy interventions for young~     people.~   "
46848|NCT02443831|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed~     CD19+ haematological malignancies.~   "
36456|NCT02579837|"~     Diabetic eye disease causes major vision loss in many Canadians and is costly. There are~     effective preventions and treatments for diabetic eye disease but they strongly depend upon~     regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA)~     guidelines recommend annual screening by eye care professionals, either in-person or through~     interpretation of dilated pupil retinal photographs.~      Despite the benefits of screening, adherence to these guidelines is poor. Reasons include~     patient barriers, i.e. need for eye drops, time off work, wait times, and transportation~     issues. An option to minimize these barriers is to screen using a camera called~     non-mydriatic ultra-widefield (UWF) retinal imaging. This can be quickly done without eye~     drops on the same day as patients' regularly scheduled diabetes clinic visits.~      In this study, the investigators will compare the UWF camera to the usual screening approach~     recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye~     screening to either be screened using the UWF camera on the day of their diabetes clinic~     visit or be screened by their usual eye care professional. The investigators' prediction is~     that same-day screening with UWF imaging will find more patients with diabetic eye disease~     who need treatment compared to usual screening.~   "
36457|NCT02579824|"~     This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come~     back) and/or refractory (has not responded to treatment).~      The goal of Part 2 of this clinical research study is to continue to study the safety of the~     highest tolerable dose found in Part 1 of the study.~   "
36458|NCT02579811|"~     Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who~     have already received some treatment. It works by reducing blood flow to a tumor. Axitinib~     is normally give at 5mg twice per day and sometimes this dose is increased if patients~     tolerate it. The purpose of this study is to figure out a different way to decide which dose~     of axitinib each patient should receive based on the side effects they experience.~   "
36459|NCT02579798|"~     General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory~     mechanics. These effects result primarily from atelectasis formation. They occur in 85-90%~     of healthy patients in the minutes following the induction when a positive end expiratory~     pressure (PEEP) is not used.~      The functional residual capacity (FRC) of obese patients during general anesthesia is even~     smaller than the one of healthy patients. There is a direct relationship between the body~     mass index and the decrease of the functional residual capacity. Obese patients have~     therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum~     will increase the decrease of the CRF, and thus aggravate the formation of these~     atelectasis.~      Atelectasis affect the peroperative gas exchanges and are likely to be involved in the~     worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance~     of secretions and the lymph flow, which predispose to lung infections.Taking all these~     factors into account, it is logical to think that the atelectasis presence can lead to an~     increase of the postsurgical morbidity (respiratory distress, infections). That is why~     actively fighting against the formation of these atelectasis is important.~      There is a lack of scientific evidence to say that the strategies against atelectasis as~     PEEP have a significant impact on the patient's postoperative status. The expected clinical~     benefits balance (reduction of respiratory distress episodes, infections and mortality)~     versus the risks linked to the maneuvers done to reduce the development of atelectasis~     (barotraumas, cardiac complications) remains to be determined.~      The primary goal of this study is to evaluate the impact of two different alveolar~     recruitment strategies on the incidence of postoperative hypoxemia in obese patients after~     bariatric surgery.~      The secondary objectives of this study are to compare the number of recruitment maneuvers,~     the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired~     oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2~     gradient (arterial and end tidal gradient) between two alveolar recruitment strategies~     applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve~     gastrectomy).~      The tertiary objectives of this study are to report the number of respiratory complications~     and postoperative wound infections at the 30th postoperative day.~   "
36460|NCT02579785|"~     The purpose of this study is to assess whether a mobile phone intervention can be~     effectively used to improve post menstrual regulation contraceptive uptake and continuation~     in Bangladesh.~      The study will consist of two phases: Phase I: A formative phase to understand barriers to~     post-abortion contraceptive uptake and continuation and the content and modality of messages~     most appropriate for women in the study areas; and Phase II: An RCT will be conducted to~     test the effectiveness of the mHealth intervention developed during the formative phase on~     contraceptive use.~   "
36461|NCT02579772|"~     The main purpose of this study is to determine whether pharmacological treatment with~     N-acetylcysteine improves central and peripheral cardiorespiratory control and physical~     capacity in COPD patients with mild-to-moderate airflow obstruction.~   "
36462|NCT02579759|"~     The purpose of this study is to determine whether PXT3003 is effective and safe in the~     treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will~     assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated~     for 15 months.~   "
36463|NCT02579746|"~     The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium~     (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on~     blood pressure, health-related quality of life, and health service utilization. Half of~     participants received usual care while the other half received the DASHNa-CC intervention.~   "
36464|NCT02579733|"~     The aim of this study is to determine whether azathioprine is effective for mucosal healing~     in UC patients who achieved clinical remission by the first course of corticosteroids but~     not mucosal healing in endoscopy.~   "
36465|NCT02579720|"~     The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex®~     Quattro as a short-term revaccination in patients who have already been successfully~     desensitized at least five years ago against grass-pollen but developed a recurrent allergy.~   "
36466|NCT02579707|"~     This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of~     AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a~     2-period crossover design. PART 2 is an open-label study to determine the safety and PK~     parameters of a single 1000-mg oral dose of AG-120.~   "
36467|NCT02579694|"~     The purpose of this retrospective-prospective clinical evaluation is to determine whether~     the SLIC Screw System provides provisional fixation to allow biological healing of the~     scapholunate interval.~   "
36468|NCT02579681|"~     The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate)~     treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives~     of this study are to further assess BG00012 treatment effect on cognition, predictors of~     cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression,~     fatigue, quality of life, and work and social life activity.~   "
36470|NCT02579655|"~     The purpose of this study is to determine the effect of two novel interventions; (1) a~     value-based formulary which eliminates copayment for selected high-value medications (proven~     to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient~     education program aimed at lifestyle modification and optimal drug use, combined with relay~     of information on medication use, on the risk of adverse clinical outcomes (mortality, heart~     attack, stroke, need for coronary revascularization, and chronic disease related~     hospitalizations) in low-income seniors with chronic conditions over three years.~   "
36471|NCT02579642|"~     Ketamine has been used successfully as the sole medication for anesthesia in the setting of~     electroconvulsive therapy (ECT), and has more recently been studied as an adjunct agent in~     combination with propofol (the most commonly used anesthetic agent) to induce anesthesia for~     ECT. New literature postulates an anti-depressant effect of ketamine, which in ECT~     specifically may be helpful with regards to the overall goals of therapy (i.e. ECT indicated~     for severe or treatment-resistant depression).~      Current research focusing on ketamine with respect to its anti-depressant effect suggests it~     may even represent an alternative to ECT. This study will seek to determine whether ketamine~     when used in low-doses as an adjunct to propofol-based anesthesia for ECT has~     anti-depressant effects and whether it influences the characteristics of recovery from~     anesthesia in the ECT setting (i.e. vital sign parameters such as blood pressure and heart~     rate, quality of recovery, etc.).~   "
36472|NCT02579629|"~     The main purpose of this study is to examine if pain levels treated with intrathecal (IT)~     preservative-free morphine (PFM) after a cesarean section improve with the additional use of~     continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump~     system.~   "
36473|NCT02579616|"~     This is a multicenter, single arm, open-label study in participants with unresectable BTC~     and disease progression or failure following one prior gemcitabine-based doublet~     chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other~     platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase~     that will last within 21 days; a Treatment phase that will consist of study treatment cycles~     and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin~     immediately after the Off-Treatment Visit and will continue as long as the participant is~     alive, unless the participant withdraws consent, or until the End of Study.~   "
36474|NCT02579603|"~     This is a phase IV, twelve week, open label, randomized, parallel group study to assess~     safety and tolerability of combined treatment with nintedanib and pirfenidone.~      A secondary objective is to assess the exposure based on PK trough concentration values to~     nintedanib either given alone or in combination with pirfenidone and to assess the exposure~     of pirfenidone when combined with nintedanib.~   "
36475|NCT02579590|"~     Female sexual dysfunction is age-related, progressive, and very common condition. The~     physiology of the female sexual function is a complex condition affected by emotional,~     medical and hormonal elements.~      Progestogen-only contraception relies on progestogens alone to achieve contraception. There~     are several progestogen only contraceptive methods include progestogen only pill (minipill),~     subdermal implants, Depo-Provera (DMPA) and levonorgestrel intrauterine system. Many studies~     in literature reported the negative effect of combined oral contraceptive pills (COCs) on~     female sexual function due to decrease in bioavailability of testosterone and increase level~     of sex hormone binding globulin (SHBG) which leads to decrease in free testosterone level~     contributes to dysfunction.~      However, the progesterone only methods contains no estrogen, so it has less effect on sex~     hormone binding globulin and therefore less effect on free testosterone. DMPA (injectable~     progestins) is an injectable progestin is a highly reliable form of contraception. Nelson in~     1996 found that about 6% of women using DMPA reported either lost or decreased libido. More~     recent study by Fortenberry in 2011 reported that DMPA had no effect on sexual interest~     compared with nonusers of any hormonal method of contraception in an adolescent population.~     The etonogestrel implant (Implanon) is a single rod that is inserted into the medial side of~     non dominant upper arm. Although in general, it is very effective and has relatively low~     side effect, a decreased libido has been noted.~      Cerazette is a progestogen-only contraceptive pill containing 75 micrograms of desogestrel.~     It acts mainly by inhibiting ovulation. Cerazette users also may complain of decreased~     libido.~      The estrogen is the main hormone which responsible for vitality of the pelvic organ~     especially the vagina. The main mechanism of action of the DMPA, Implanon and Cerazette is~     inhibition of ovulation, which leads to decrease in the estrogen level, which causes a drop~     in blood flow in uterine artery and accordingly the vagina artery. That can affect vaginal~     lubrication, causing the vagina to be too dry for comfortable sex.~   "
36476|NCT02579577|"~     The population of children with life-limiting illnesses (LLI) in England is increasing and~     there is growing need to improve the quality of children's palliative care. Families of~     children with LLI are confronted with many care decisions for their children, such as~     whether and when to commence artificial nutrition or ventilation. They may also have the~     opportunity to consider the care that may be appropriate for their child in the future.~     Despite the important decisions families and professionals are required to make, there is~     little empirical evidence regarding the process of decision making and future planning for~     this population. Few studies have investigated the perspectives of multiple stakeholders and~     none have addressed multiple perspectives longitudinally. Therefore the relational and~     contextual aspects of decision making and future planning for children with LLI have as yet~     not been identified.~      A multiple embedded case study utilising ethnographic methods (semi-structured interviews,~     observation and notes review) is proposed to address this knowledge gap. Families of~     children with LLI cared for in either of two participating hospitals will be recruited and~     followed up for up to 12 months. The family will be invited to nominate 'significant others'~     (e.g. relatives, friends, health care professionals) who assist them in decision making and~     future planning, to participate in the study. Outpatient clinic appointments or ward rounds~     during periods of hospitalisation will be observed and semi-structured interviews will be~     conducted approximately three times with each participant. Medical notes will be reviewed at~     the end of the study.~      This research will enable a better understanding of the experiences and preferences for~     engaging in decision making and future planning from the perspectives of all stakeholders.~     It will also provide an awareness of the communication practices involved in discussions and~     the networks of care surrounding children with LLI, including specific support needs in~     relation to their role.~   "
36477|NCT02579564|"~     The purpose of this multi-center clinical trial is to verify more effective on local control~     of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant~     human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar)~     compared with cisplatin perfusion, with acceptable side effects.~   "
36478|NCT02579551|"~     This clinical trial studies the effectiveness of narrow margins in patients with low-risk~     basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the~     area of normal tissue around a tumor taken out during surgery to make sure all of the cancer~     is removed. This clinical trial studies tissue samples to determine the least amount of~     tissue that must be removed to give an acceptable cure rate. This may allow less normal~     tissue to be removed from patients and may be a less expensive surgery.~   "
36479|NCT02579538|"~     This observational study aims to determine the association between preoperative cognitive~     flexibility and the risk of developing PPSP by preoperative administration of cognitive~     tests.~   "
36570|NCT02578329|"~     The purpose of this study is to determine whether a Mediterranean Diet, personalized in~     terms of total calories, total lipids and balanced in terms of saturated, mono- and~     poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and~     reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary~     advice.~   "
36480|NCT02579525|"~     Background: The recommended monitoring and target levels in septic shock (SSC Guidelines~     2012) including mean arterial pressure (MAP) target are not based on robust clinical data.~      Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG)~     treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory~     target guided standard care.~      Design: A prospective phase II two-parallel-group open-label randomized controlled trial~      Interventions:~        1. Intervention group- Targeted tissue perfusion guided (TTP) - care.~        2. Control group - Macrocirculatory - guided (MCG) care.~      Randomization: 1:1 stratified according to the site and presence or absence of known~     hypertension.~      Trial size: 200 randomised patients in 4 ICUs.~   "
36481|NCT02579512|"~     The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient~     data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG.~     Patients with suspected coronary artery disease are conventionally diagnosed and treated by~     cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless~     clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a~     nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is~     usually performed to increase the accuracy of diagnosis. But these examinations are not~     accessible to all patients, and are time-consuming and costly.~   "
36482|NCT02579499|"~     To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013~     ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary~     prevention. Total 4400 patients with coronary artery disease patients requiring statin~     treatment were categorized fixed high-potent statin group and targeted LDL-C group. The~     investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event~     (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2.~     Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism,~     4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5.~     Aortic intervention or operation, 6. ESRD with renal replacement therapy).~   "
36483|NCT02579473|"~     SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent~     dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain~     that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via~     a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic~     (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible~     if they have early, stable or untreated Parkinson's disease and are still experiencing motor~     fluctuations.~   "
36484|NCT02579460|"~     The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by~     acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell~     cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF~     (vascular endothelial growth factor) signaling that triggers the EMT~     (epithelial-mesenchymal-transition) program in Barrett's esophagus.~   "
36485|NCT02579434|"~     The study objective is to evaluate and validate of endogenous markers for the assessment of~     CYP3A activity in Korean healthy subjects using metabolomics.~      In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total~     25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects~     will be administered midazolam I.V. 1 mg.~   "
36486|NCT02579421|"~     The purpose of this study is to examine the role of progesterone (a naturally occurring~     hormone found in both men and women) on reducing marijuana use. The investigators will see~     if progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.~   "
36487|NCT02579408|"~     Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its~     presence among donors of living donor liver transplants could affect the outcomes of~     recipients of liver transplantation. By using controlled attenuation parameter (CAP)~     measurements, the investigators aim to investigate the association of CAP measurements and~     severity of fatty liver among liver donors in the recipient outcomes of living donor liver~     transplantation.~   "
36488|NCT02579395|"~     In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2~     Diabetes (T2D) will be randomly assigned to either the collaborative implementation~     intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs)~     condition, or the control condition. As this is a pilot study, randomization for the~     experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental~     conditions will contain up to 36 participants and the control condition will contain up to~     18 participants. Adults with T2D who are living with a romantic partner, not meeting current~     physical activity guidelines but able and willing to begin a new physical activity (PA)~     routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the~     experimental manipulation. Partners will report on their own investment in the patient's~     goal and patients will report on their own PA self-efficacy. Patient's PA will be measured~     through self-report, partner report and accelerometers for a week prior to each survey~     assessment. These specific aims are planned:~      AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     partner investment in partners of adults with T2D than do individual IIs or control.~      AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     patient PA self-efficacy in adults with T2D than do individual IIs or control.~      AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     patient PA in adults with T2D than do individual IIs or control.~   "
36489|NCT02579382|"~     The study will evaluate the safety, tolerability, and efficacy of vesatolimod (formerly~     GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being~     treated.~   "
36490|NCT02579369|"~     This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in~     patients with Dystrophic Epidermolysis Bullosa.~   "
36491|NCT02579356|"~     The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are~     having 2 groups in each part that have divided period 1 and period 2, and wash-out period is~     16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg)~     once a day for 6 days.~   "
36492|NCT02579343|"~     This will be a randomized, single blind study of 6 weeks duration involving the use of~     auricular acupuncture or sham acupuncture in the adjunctive treatment of depression in~     college students.~   "
36493|NCT02579330|"~     In various transanal and anal procedures it is desirable to clean the operating field from~     stool contamination. Thus mechanical bowel preparation is not well tolerated by patients.~     Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be~     performed and enable a clean operating field. In this randomized controlled trial the~     macroscopic contamination of the rectum with and without Coloshield is compared using the~     Boston Bowel Preparation Score (0-3).~   "
36494|NCT02579317|"~     Despite conscious intentions to remain abstinent, persons with substance use disorders often~     find that negative emotions and environmental cues automatically trigger drinking and~     other substance use. This study aims to test whether activating the baroreflex mechanism can~     be used in the moment to help resist drinking triggers. It consists of 3 phases~     (Recruitment, Intervention, Follow-up).~      Stage 1: Trained research staff conduct a comprehensive clinical interview and~     questionnaires to assess participant's mood, substance use, and triggers. Participants are~     paired with a Primary Research Clinician (PRC) who will work with them during the~     intervention.~      Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive~     Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory~     sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway,~     NJ. Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers~     University Brain Imaging Center, Newark, NJ). Participants are randomized into an active~     intervention or control group after the pre-intervention lab session. They are given an~     iPhone and trained to use a paced breathing app that is pre-loaded onto the phone.~     Participants in both groups use their app any time they anticipate or experience a trigger~     to drink or use drugs. Participants are compensated for their use of the app and the time~     for participation. To ensure that participants are correctly performing the paced breathing~     task, their PRC visit with them weekly to provide coaching sessions using a computer-based~     biofeedback program. During the 4th week, ECG and respiration data are collected.~     Participants also complete questionnaires about mood and triggers, and provide feedback on~     the usefulness of the app.~      During the lab sessions, participants complete a series of questionnaires and ECG, blood~     pressure and respiration are collected during four 5-minute tasks (resting baseline,~     non-resonance breathing, resonance breathing, and visual processing/attention). During the~     neuroimaging sessions, participants are placed in the scanner for structural scans and four~     5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded.~      Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete~     questionnaires about their quality of life across multiple domains and the usefulness of the~     app.~   "
36495|NCT02579304|"~     Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its~     procedural feasibility and safety in a prospective series of 20 patients with diffuse~     interstitial lung diseases (DILD) who are referred for invasive histopathological~     diagnostics~   "
36496|NCT02579291|"~     Individuals who had experience a stroke usually suffer from spasticity at medium and~     long-terms. The presence of spasticity in the lower extremity implies several impairments~     for standing and walking inducing high disability. A recent study has proposed the use of~     dry needling for improving spasticity in the lower extremity. No study has investigated the~     effects of deep dry needling inserted into spastic musculature in stabilometry and moto~     function in patients who had experience a stroke. A randomized controlled trial~     investigating the effects of the inclusion of deep dry needling into a Bobath interventional~     program on spasticity, motor function and balance (stabilometry) in individuals who had~     experience a stroke~   "
36497|NCT02579278|"~     In almost one third of patients with rectal cancer, cancer spreads through the bowel wall~     into nearby veins which can be seen on MRI scans and is known as mrEMVI. It has been~     observed that this is linked with worse survival due to the spread of cancer to the liver~     and other organs. The investigators think that this may occur by spread of cancer cells in~     the blood stream. Circulating cell-free tumour DNA (ctDNA) can be detected in the blood of~     patients with both metastatic and primary carcinoma (but not healthy individuals).~      This trial does not interfere with the patient's routine treatment pathway. Participants~     will be grouped into whether or not they demonstrate mrEMVI on their post-radiotherapy MRI~     scan. 20 patients who are mrEMVI positive and 20 patients who are mrEMVI negative will have~     blood samples taken pre-surgery and then again during surgery and a comparison will be made~     between the two groups. If the investigators can find a link between the cancer cells seen~     in blood to mrEMVI they may be able to use this test to help guide treatment in the future.~     This study will serve as the feasibility of a larger, comparative study.~   "
36498|NCT02579265|"~     To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of~     study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during~     the first 28 days of study treatment, confirmed by a second sample collected 7 days after~     the first sample.~   "
36499|NCT02579252|"~     This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with~     mild Alzheimer's disease.~      60% of participants will receive AADvac1 and 40% of participants will receive placebo.~   "
36500|NCT02579239|"~     The purpose of this study is to assess the safety and biological activity of ATYR1940 in~     patients with Limb Girdle (LGMD2B) or Facioscapulohumeral Muscular Dystrophy (FSHD).~   "
36501|NCT02579226|"~     This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811~     at increasing doses in patients with advanced solid tumours and for whom no standard of care~     exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a~     dose expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment~     will proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the~     recommended Phase II dose (RP2D) will be identified. The study will also characterize the~     pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity~     by assessing anti-tumour activity in patients. Once the MTD is established, Part B (the dose~     expansion phase) will commence and will enroll patients in 3 groups. Part B will further~     explore PK parameters, safety, tolerability, and preliminary anti-tumour activity of the~     AZD2811 RP2D as monotherapy (Group 1) in patients with relapsed/refractory SCLC, and when~     combined with irinotecan (Group 2 and Group 3).~      In Part B-Group 2, PK, the safety and tolerability of the AZD2811 will be assessed in a~     lead-in cohort when given in combination with irinotecan. When a safe and tolerated dose for~     the AZD2811 and irinotecan combination has been defined, an additional 30 patients will be~     enrolled to assess efficacy (Part B-Group 3).~   "
36502|NCT02579213|"~     electronic nose- the tiny sensors, will smell and detect the changes in the sample of~     abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.~   "
36503|NCT02579200|"~     The purpose of this study is to determine whether inspiratory muscle training is effective~     to improve breathless and exercise intolerance in symptomatic patients with chronic~     obstructive pulmonary disease (COPD) plus chronic heart failure (HF).~   "
36504|NCT02579187|"~     To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or~     microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory~     response on the basis of different clinical, radiographic, histologic and biomolecular~     outcomes in post-extraction socket defects in humans.~   "
36505|NCT02579174|"~     1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy~          as computed axial tomography (CT)~        2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional~          alignment of Total Knee Replacement implants.~        3. To evaluate differences in total knee replacement implant alignment in patients whose~          arthroplasty is performed using manual or custom instrumentation derived from~          preoperative CT~   "
36506|NCT02579161|"~     The Investigators objective is to compare the clinical efficacy of a single-day protocol~     with a short-course protocol for PCNL. The investigator hope is to reduce the use of~     possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further~     propagation of resistant microbes.~   "
36507|NCT02579148|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     feasible; 2) is treatment effective in improving the disease pathology of patients with~     diagnosed diabetic erectile dysfunction.~   "
36508|NCT02579135|"~     This study evaluates an educational web-based intervention designed to increase adolescent~     girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health~     Education and Relationship Training). Half of participants will receive Project HEART and~     half of participants will receive Project Growing Minds, an attention-matched control~     website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of~     this work is to help girls reduce their risk of HIV and other sexually transmitted diseases~     and to avoid unplanned pregnancies.~   "
36509|NCT02579122|"~     In view of the fact that little is known about the pre- and post-interventional coagulation~     management of phenprocoumon patients with reviparin at general practices in Germany, an~     observational study is being initiated to evaluate the effectiveness and tolerability of~     reviparin in the area of outpatient, general practice-based care in the context of bridging~     therapy. Patients for whom bridging therapy with low-molecular weight heparin (LMWH) was~     specified and for whom the LMWH reviparin was chosen for this purpose shall be investigated.~   "
36510|NCT02579109|"~     Introduction:~      Autism spectrum disorder is characterized by deficits in three functional domains: language~     and communication, social reciprocity, and the presence of restricted interests/repetitive~     behaviors. There's also deficits in social cognition. When having a face-to-face~     conversation, a listener not only hears what a speaker is saying, but also sees the~     articulatory gestures that accompany those sounds. Speech signals needs then a multisensory~     processing. Impairments in multisensory perceptual binding may be particularly relevant in~     ASD, given that hallmark features of the disorder include difficulties in speech,~     communication, and social interactions.~      Objectives:~      The investigator suggest that atypical multisensory processing in ASD may have an impact on~     speech perception and social processing.~      Aims:~      Methods:~      This pilot study measures free recall scores in 3 lists of words presentation after 30~     minutes. In the first condition (CI) words are only listening. In the second condition (CII)~     words are associated with a picture of a mans face. In the third condition (CIII) words are~     associated with a video of a man speaking. Three lists are homogeneous form words~     characteristics (lexical frequency, emotional valence norm, imageability). Participants were~     7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).~      The investigator would create some new tools for exploring the treatment of a social~     information. These tools should be the closest of a ecological social interaction.~   "
36511|NCT02579096|"~     This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum~     uric acid and therefore prevent further gout attaches. These therapies have never been~     compared at appropriate doses. Further, they will be study in patients with kidney disease~     for the first time.~   "
36512|NCT02579083|"~     The purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal~     antibody film for vaginal application that is being developed to potentially reduce the~     transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).~   "
36513|NCT02579070|"~     The purpose of this study is to investigate whether regular measurement of skin foot~     temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients~     at high risk of foot ulceration. It is planned to regularly measure the temperature of the~     feet of people with diabetes who have already had a foot ulcer which has subsequently~     healed. These measurements should allow the identification of hotspots on the foot and may~     be helpful when advising about ulcer risk and providing preventative treatment. It is hoped~     to find out whether the regular use of thermal images taken with the DFUPS device together~     with standard foot treatment may reduce the number of people with diabetes developing ulcers~     or even prevent foot ulcers.~   "
36514|NCT02579057|"~     This study evaluates the clinical efficacy of subcutaneously administered Furosemide~     Injection Solution versus intravenous administration of Furosemide Injection, United States~     Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated~     heart failure. Half of the patients will receive a subcutaneously administered Furosemide~     Injection Solution; the other half will receive an intravenous administration of Furosemide~     Injection.~   "
36515|NCT02579044|"~     This is a phase I/II dose-escalation trial of everolimus in combination with lonafarnib in~     Hutchinson-Gilford Progeria Syndrome (HGPS) and progeroid laminopathies (henceforth~     progeria). The study will be conducted at a single clinical site utilizing the Clinical~     and Translational Study Unit (CTSU) at Boston Children's Hospital. Lonafarnib will be~     administered at doses previously established in the pediatric population and in this~     population of progeria subjects. This study will first determine the dose-limiting~     toxicities (DLT) and the maximum tolerated dose (MTD) of everolimus when administered in~     combination with lonafarnib. It will then determine the efficacy of everolimus when~     administered at its MTD in combination with lonafarnib for disease in progeria.~   "
36516|NCT02579031|"~     PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data~     from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant~     reduction in MACE among patients with STEMI undergoing primary PCI with newer generation~     stents with enhanced biocompatibility.~      The present trial aims at filling the current gap of evidence by providing randomized data~     to establish the superior clinical outcome with an ultrathin strut third-generation DES with~     biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing~     primary PCI, compared to the current state-of-the art second-generation DES with permanent~     polymer.~   "
36517|NCT02579018|"~     There are two major goals of this investigation. First, to develop pilot data to justify a~     larger randomized clinical trial of an intervention designed to train interoceptive signals~     (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the~     investigators will determine whether persons with AN have similar or different IS and IR for~     heart rate while exercising as compared to age and gender matched controls.~   "
36518|NCT02579005|"~     This project will assess the feasibility of treating advanced cancer using the immune~     system, without any anti-cancer drug. In this pilot study, the investigators propose~     combining low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells~     obtained from a donor. The patients will receive radiotherapy directed to one of the~     patient's tumors, as well as an immunomodulatory drug called cyclophosphamide. Thereafter,~     they will receive the infusion of donor immune cells.~   "
36519|NCT02578992|"~     The purpose of this study is to investigate two different patient's head and neck~     positions(neutral head position and head-lift position) for the effectiveness of orotracheal~     intubation with using the Clarus Video System (Trachway®) intubating stylet.~   "
36520|NCT02578979|"~     Paroxysmal atrial fibrillation is often undetected because characteristics such as short~     duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at~     the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal~     atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission.~     Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial~     fibrillation. However, systematic review suggests Holter monitoring will identify atrial~     fibrillation in only an additional 4.6% of patients, no better than detection rates observed~     in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with~     sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no~     recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial~     12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute~     ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic~     stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation~     strategy, including modality, duration of investigation, and patient subgroup remains~     undefined, not only for efficacy in the detection of atrial fibrillation, but also~     cost-effectiveness in healthcare systems. The objective of this project is to conduct a~     pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG~     once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute~     ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.~   "
36521|NCT02578966|"~     The purpose of this study is to compare the effectiveness of a traditional oral health~     educational program and a program based on the theories of the Motivational Interview~     directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2~     and 3 years of age).~   "
36522|NCT02578953|"~     This will be a single center, open-label, single dose, randomized and 2-way crossover study~     in healthy Japanese male subjects under fasting conditions. The study will be conducted to~     determine the bioequivalence between dutasteride capsules manufactured at GSK (test product)~     and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese~     male subjects. Subjects will have a screening visit within 30 days prior to the first dose~     of study treatment, two treatment periods separated by 28-days washout period, a re-visit~     10-14 days after the second dose for the first follow-up and a second follow up via~     telephone 50-54 days after the second dose. The total duration of the study will be~     approximately 15 weeks from screening to the second follow up.~   "
36523|NCT02578940|"~     The main aim is to assess the impact of using fluciclovine (18F) (as a PET imaging~     radiotracer) on the clinical and treatment decision required for managing patients with~     biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment~     with the intention of providing disease cure. Also, this study will consolidate the~     information regarding diagnostic performance of fluciclovine PET/CT in a large number of~     prospectively followed patients at several centres in the UK and assess the effect of PSA~     level on the likelihood of detecting cancer lesions by fluciclovine (18F).~   "
36524|NCT02578927|"~     The objective is to investigate whether the ingestion of green tea prior to physical~     exercise improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo~     study. Fifteen hypertensive (53±4.5 years) performed three procedures: green tea+exercise~     (GT+Ex), placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after~     ingesting 2g of green tea or placebo, they performed treadmill walking (60 minutes), 60 to~     85% of maximum heart rate intensity in procedures with exercises. BP was measured at rest~     and at every 10 minutes after exercise (60 minutes). Blood samples were taken before the~     ingestion of green tea or placebo and immediately after exercise to determine~     Malondialdehyde (MDA) and Nitrite (NO) dosages. Reduction of systolic BP compared with the~     rest, during PL+Ex recovery procedure.~   "
36525|NCT02578914|"~     This is a randomized, parallel, single center, double masked, vehicle controlled study. The~     purpose of this study is to determine the activity and safety of NS2 in patients with grass,~     tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be~     randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic~     Drops Vehicle (0.0%).~      Free aldehydes are thought to be related to inflammatory conditions such as allergic~     conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether~     it may decrease inflammation by lowering aldehyde levels.~   "
36526|NCT02578901|"~     The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with~     tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to~     primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.~   "
36527|NCT02578888|"~     This randomized clinical trial studies a palliative care program in improving the quality of~     life of patients with high-risk gynecologic malignancies that is original or first tumor in~     the body (primary) or has come back (recurrent). Palliative care is care given to patients~     and their families facing the problems associated with life-threatening illness, through the~     prevention and relief of suffering by means of early identification and impeccable~     assessment and treatment of pain and other problems, physical, psychosocial and spiritual.~     Studying a palliative care program may help doctors learn more about patients quality of~     life, use of healthcare services, and the relief of pain.~   "
36528|NCT02578875|"~     Background:~      Researchers are testing a new way to find out what causes infections in people in hospitals.~      Current techniques use chemical or biological tests on a person s samples. Samples are~     blood, tissue, stool, saliva, urine, etc. Researchers are testing new techniques that use a~     device called MiSeq. It can sequence all of the DNA (genetic material) in a sample. This may~     show microorganisms, such as bacteria, fungi, and viruses that cause infection. Researchers~     want to know if the new test works as well or better than current tests. They will do this~     by looking at about 250 samples.~      Objective:~      To test if MiSeq works as well as or better than current tests to identify microorganisms~     that cause infection.~      Eligibility:~      NIH patients whose samples have been sent to the Microbiology Service s lab for routine~     microbiologic testing.~      Design:~      Participants will consent to have samples they gave as part of their routine medical care~     used in the study. For those under age 18, a parent or legal guardian will consent.~   "
36529|NCT02578862|"~     Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve~     visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease~     in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation~     associated with inhaled anesthetics. This may be especially important in cases of advanced~     inflammatory sinus disease, when visualization may be most compromised. The goal of this~     study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled~     anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.~   "
36530|NCT02578849|"~     The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of~     noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission~     tomography of patients with early and advanced Parkinson's disease with or without 3,4~     L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and~     evaluation of whether these mechanisms can be influenced therapeutically.~      Hypotheses:~        1. The investigators argue that release in human cortical and subcortical brain regions of~          norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in~          Parkinson's disease patients with L-DOPA- induced dyskinesia than in patients without~          this complication. This hypothesis will be tested by measuring antagonist~          [11C]yohimbine binding to alpha-2 adrenoceptors before and after L-DOPA challenge.~        2. If so, it is argued that the greater rise of norepinephrine, measured as [11C]yohimbine~          displacement after L-DOPA challenge, is the result of down-regulation or loss of~          norepinephrine transporters. This hypothesis will be tested by measuring the binding of~          [11C]MeNER, a tracer of norepinephrine transporters.~        3. If so, the investigators argue that the greater decline of [11C]MeNER binding is~          significantly correlated to the symptoms of Parkinson's disease, as proof that patients~          with more severe loss of noradrenergic terminals exhibit more severe motor deficits.~   "
36531|NCT02578836|"~     This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel~     Gastroplasty (FG). The purpose of the study is to:~        -  Document that weight loss occurs (12 months)~        -  Determine if it alters general wellbeing (emotionally and physically)~   "
36532|NCT02578823|"~     The purpose of this study is to determine whether targeted temperature management at~     36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital~     cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this~     purpose, the current pilot study will be undertaken to establish the feasibility, safety,~     and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain~     unconscious after resuscitation from IHCA.~      Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or~     conventional treatment group(n=20). Randomization will be performed with stratification~     according to initial rhythm (shockable vs. non-shockable).~   "
36533|NCT02578810|"~     Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of~     exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity~     and mortality worldwide.1 Standardization of antenatal and postnatal assessment and~     surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model~     of preeclampsia have been associated with reduced maternal morbidity.~   "
36534|NCT02578797|"~     The purpose of this study is to determine whether daily treatment with apalutamide affects~     the ventricular repolarization in participants with Castration-Resistant Prostate Cancer~     (CRPC)~   "
36535|NCT02578784|"~     The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1~     year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts~     62-87%), necessitating a therapeutic measure to preserve dialysis access during this period~     in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a~     standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success~     rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained~     (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting~     balloon (carrying with small knives on its surface) is performed, leading to a success rate~     of 89%. However, a problem is the high incidence of restenosis, which is about 40% for~     recurrent stenosis and over 10% in de novo stenosis.~      The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in~     the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is~     unknown.~      Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of~     a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses~     compared to the sole use of a cutting balloon.~   "
36536|NCT02578771|"~     ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to~     demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will~     be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product~     and reference positive control will be compared; ZuraPrep non-active and negative control~     will be compared. Each subject will receive two of the planned treatments, one on the left~     side of body and one of the right. Study duration for subjects - 3 to 4 weeks.~   "
36571|NCT02578316|"~     The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib~     in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had~     failed, existing therapies.~   "
47457|NCT02435862|"~     A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed~     to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with~     Non-Proliferative Diabetic Retinopathy.~   "
36537|NCT02578758|"~     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol~     (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major~     depression disorder, dysthimyc disorder, obsessive-compulsive disorder and four anxiety~     disorders: panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety~     disorder) both in terms of efficacy regarding depressive and anxiety symptomatology and its~     potential impact on higher-order psychological dimensions (neuroticism/behavioral inhibition~     and low positive affect/behavioral activation) in a community sample. It will also be tested~     the differential effect of a specific treatment component based on positive psychology~     techniques in positive affect. The main hypotheses are: 1) both modalities of the protocol~     (TP and TP+PA) will be more effective than the WL condition in the primary outcome measures.~     Investigators also expect scores on positive affect to be higher in the TP+PA condition than~     in the TP condition.~   "
36538|NCT02578745|"~     Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound~     therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface~     - has been used to treat open wounds since the late 1990s. Experimental evidence suggests~     NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing~     bacterial contamination. Although effectiveness of prophylactic NPWT is biologically~     plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is~     lacking. The objective of this pilot randomized controlled trial of 120 patients to test the~     hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after~     cesarean in obese women. The investigators will randomly assign obese women undergoing~     cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin~     closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for~     Disease Control and Prevention (CDC) criteria and other wound complications (separation,~     hematoma, seroma) after cesarean.~      Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of~     wound complications; patient pain and satisfaction scores; physician office visit or~     emergency department (ED) visits for SSIs; and hospital readmission for wound complications.~   "
36539|NCT02578732|"~     Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to~     FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated~     with the ability to administer at least 10 cycles of therapy. Investigators therefore will~     evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.~   "
36540|NCT02578719|"~     This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine~     compared to placebo in chronic migraine patients.~   "
36541|NCT02578706|"~     Advances in antiretroviral therapy (ART) have resulted in increased survival of the~     HIV-infected population; however, this gain in longevity is associated with an increased~     risk of cardiovascular disease (CVD). Although ART and traditional risk factors contribute~     to CVD in this population, heightened markers of immune activation, inflammation, and~     coagulation independently predict morbidity and mortality, suggesting that dysregulation of~     these systems plays a significant role in the increased risk of CVD. The investigators~     believe that platelet activation is an important driver in HIV-associated immune activation,~     inflammation, and coagulation, leading to an increased CVD pathophysiology and risk.~     Platelets initiate thrombus formation and also play a key role in vascular inflammation by~     releasing pro-inflammatory mediators and cross-talking with other relevant cell types~     including leukocytes. Researchers have described platelet hyperreactivity in chronic HIV~     infection. Importantly, the investigators demonstrated that one week of anti-platelet~     therapy (aspirin) decreased platelet activation and immune activation, with an improved~     trend in inflammation and immune parameters. The overall hypothesis is that platelet~     activation is a major driver of immune activation, inflammation, and thrombosis in~     ART-treated HIV infected patients. The purpose of the proposed proof-of-concept study is to~     understand the mechanism(s) by which anti-platelet therapy improves immune and inflammatory~     parameters in chronic HIV infection. To test this, the immune modulating and~     anti-inflammatory effects of 24 weeks of the anti-platelet drug aspirin as compared to the~     anti-platelet drug clopidogrel will be evaluated. Given their different mechanisms of action~     and inhibitory potency, the investigators can differentiate whether the potential benefits~     are mediated via inhibition of arachidonic acid (aspirin) or inhibition of ADP (clopidogrel)~     or by the antithrombotic activity. A secondary goal is to perform multidimensional assays of~     platelet activity and thrombogenicity alongside immune activation assays and careful~     assessments of traditional risk factors and medication regimens, to understand which~     parameters are highly associated with thrombogenicity.~   "
36542|NCT02578693|"~     The study is designed to provide long term clinical and virologic follow up in subjects~     infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting~     antiviral agents (DAAs)-based therapy. This long term follow up study is observational and~     no treatment is provided for HCV infection.~   "
36543|NCT02578680|"~     This is an efficacy and safety study of pembrolizumab (MK-3475) combined with~     platinum-pemetrexed chemotherapy versus platinum-pemetrexed chemotherapy alone in~     participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who~     have not previously received systemic therapy for advanced disease. Participants will be~     randomly assigned to receive pembrolizumab combined with pemetrexed and platinum~     (Investigators choice of cisplatin or carboplatin), OR pemetrexed and platinum~     (Investigators choice of cisplatin or carboplatin).~      The primary hypothesis is that pembrolizumab in combination with platinum-pemetrexed~     chemotherapy prolongs Progression Free Survival (PFS) compared to platinum-pemetrexed~     chemotherapy alone.~   "
36544|NCT02578667|"~     Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft~     tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become~     part of the study population. Based on prior imaging and/or imaging at the time of the~     procedure, patients will fall into two groups, those for whom no compression is necessary to~     complete the procedure and those for whom compression may provide benefit. These would be~     selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and~     CAQ'ed interventional radiologist. The latter group would then further subdivide into those~     who give consent for use of the compression device and those who do not consent. Results of~     each group would be measured including the following: termination versus successful~     completion of the procedure; adverse events including bleeding or damage to surrounding~     structures necessitating further medical or surgical intervention.~   "
36545|NCT02578654|"~     A quasi-experitmental study of the efficacy interventions, including additional HIV care~     team daily inpatient round and three telephone calls to remind the upcoming clinic~     appointment, in improving HIV care engagement within 30 days after hospital discharge among~     HIV-infected patients.~   "
36546|NCT02578641|"~     This study is a multi-center, randomized, open label, Phase III clinical trial.~      Patients with metastatic or locally recurrent EBV-positive NPC not amenable to further~     curative chemoradiation or surgery are eligible for this study. Eligible patients are biopsy~     proven (whether earlier or at diagnosis of de novo advanced disease), undifferentiated~     carcinoma of the nasopharynx (EBV-related) who have not received first line chemotherapy for~     the treatment of advanced NPC.~   "
36547|NCT02578628|"~     The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving~     care from Empire Physicians Medical Group (EPMG), an Independent Practice Association~     located in Palm Desert, California. The system monitors routine clinical laboratory test~     results and send messages to patients and providers when action is indicated, such as when~     tests are overdue or results require extra clinical attention. This study will assess what~     happens to laboratory results, utilization of laboratory tests, and costs of care when ther~     system is discontinued.~   "
36548|NCT02578615|"~     The pilot study was conducted in the form of an open prospective single-arm observational~     study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in~     Zurich.~   "
36549|NCT02578602|"~     This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium~     in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with~     gadoxetate disodium, may help find and diagnose liver cancer and find out how far the~     disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more~     precise measurement of liver tumors than standard computed tomography (CT).~   "
36550|NCT02578589|"~     The purpose of this trial is to evaluate the effect of conservative treatment in comparison~     to arthroscopic resection of pathological medial plicae of the knee for patients with medial~     plica syndrome. The investigators expect conservative treatment to be significantly superior~     to arthroscopic plica resection with regard to symptom remission and return to prior~     functional level.~   "
36551|NCT02578576|"~     Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high~     rate of postoperative anastomotic complications and recurrences. Surgery itself can~     influence immunologic function and trigger inflammatory response, which may result in the~     flare of Crohn's disease soon after surgery (within one month), especially near the~     anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of~     operation. However, due to the the complexity of perioperative period and dangerous of~     invasive examine, it is difficult to distinguish disease flare from postoperative~     complications.~      In this study, the investigators aim to development a diagnostic method of flare-up within~     one month after surgery, which can help us to detect and then treat disease flare in time.~   "
36552|NCT02578563|"~     To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus~     patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly~     used hypoglycaemic drugs in real life clinical settings.~      To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter~     inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis~     in clinical practice setting. The study would also assess treatment patterns with SGLT2~     inhibitor patient relevant outcomes in whole population as well as pre identified patient~     subgroups.~      Primary analysis to be done at 1 year and extended analysis at 2 years.~   "
36553|NCT02578550|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal~     bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and~     tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC)~     (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF~     200/10 mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy~     participants.~   "
36554|NCT02578537|"~     Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet~     inhibition than clopidogrel, which was considered more noticeable in patients with ACS~     combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of~     ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study~     was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to~     estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet~     in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60~     ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective,~     randomized, parallel-control study and randomly assigned in a one-to-one ratio to receive~     ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the~     PRU by Verify Now at 30 days after loading dose.~   "
36555|NCT02578524|"~     This study will examine patient satisfaction and spectacle independence using a survey in~     patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens~     at least 2 years prior to administration of the survey.~   "
36556|NCT02578511|"~     This phase I trial will use a continual reassessment method (CRM) design with cohorts of~     three patients without intrapatient dose escalation. A maximum sample size of 18 patients~     will be enrolled over four potential doses to determine the maximum tolerated dose of~     ixazomib with POMP/D maintenance.~   "
36557|NCT02578498|"~     No studies have investigated if the dietary composition of carbohydrate influences the~     glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further,~     the recommended diet composition to patients with type 1 diabetes has not been thoroughly~     validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due~     to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon~     can be used as an add-on to intensive insulin treatment, these aspects need to be~     elucidated. The purpose of this study is to determine, whether diet composition of~     carbohydrate affects the glycogen stores in the liver and affects the glucose response of~     glucagon during hypoglycaemia.~      HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of~     low-dose glucagon is not associated with diet carbohydrate content.~      AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet~     influence the glycaemic response of low-dose glucagon in patients with insulin pump treated~     type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks~     differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose~     excursions.~      DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After~     participants have given an informed consent, they will go through four steps: 1) screening~     visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study~     visit and 4) second meal intervention for one week finalizing with another study visit.~   "
36682|NCT02576873|"~     A retrospective cohort study was conducted in 66 end-stage renal disease patients who~     underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial~     Hospital between 2001-2013 to determine the survival rate as well as other long-term~     outcome.~   "
36558|NCT02578485|"~     Background: The active video game (VGA) it has been studied how much to the physiological~     factors of your practice. The objective was to determine whether an AVG session promotes~     post-exercise hypotension (PEH) similar to walking exercise. Methods: Fifteen hypertensive~     (49.0 ± 1.6 years), both genders performed five randomized sessions, lasting 60 minutes: 1)~     AVG, 2) sedentary video game (SVG), 3) walk treadmill with moderate intensity (WMI), 4) walk~     treadmill with similar intensity to VGA (WGI), and 5) control without exercise (CON).~     Intensity was determined by Heart rate (HR) and Perceived Exertion (PE). Blood pressure (BP)~     and cardiac autonomic modulation (CAM) measurements were taken at rest and every 10 minutes~     post exercise for 60 minutes.~   "
36559|NCT02578472|"~     The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem~     and placebo, on driving performance as assessed by the mean difference of standard deviation~     of lateral position (SDLP) after forced awakening using a validated driving simulator test~     at 2, 4, 6 and 8 hours post-evening dose.~   "
36560|NCT02578459|"~     The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of~     pain treatment with CMM in patients with pancreatic cancer pain.~   "
36561|NCT02578446|"~     The optimal method of total knee replacement component fixation to the bone remains a~     challenge. The use of bone cement is considered the gold standard and is the preferred~     technique for most surgeons. However, uncemented fixation methods have been developed in an~     attempt to tackle problems that can be seen when cement is used. The cement-bone interlock~     can deform and degrade over the years and can lead to aseptic loosening, especially in young~     and active patients. A loosened prosthesis results in an impaired functioning and painful~     knee in daily life for which a revision of the prosthesis may be necessary. To prevent~     aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have~     been developed.~      One of these methods is to use a highly porous metal called Tritanium®. It can improve the~     biologic fixation by resembling the characteristics of trabecular bone. It is expected that~     this surface aids bone ingrowth and to have similar or even better results concerning early~     fixation properties and long-term durability compared with cemented fixation. Excellent~     results using this highly porous Tritanium have been seen in total hip surgery already.~      This single-blinded, randomized clinical trial will assess clinical and radiological~     outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved~     uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented~     Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of~     each 35 patients will be included.~      The primary outcome measure will be prosthetic migration after two years of the uncemented~     Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA.~     It is hypothesized that the new uncemented Tritanium prosthesis will perform at least~     equally good in terms of migration and clinical parameters compared with the standard~     cemented Triathlon.~      The secondary outcome measure will be long-term (10-year) survival based on the two-year~     migration patterns combined with clinical factors and radiographic aspects. In order to~     identify other clinical parameters besides the fixation of the prosthesis components,~     clinical scores and radiographic aspects will be correlated with the RSA outcome. The~     10-year results will be used to verify the predicted long-term survival results.~   "
36562|NCT02578433|"~     In recent years there has been convincing evidence of the positive effects of mindfulness~     based interventions, as a form of complementary and alternative medicine in regards to~     subjective well-being and physical health. There is growing evidence concerning the positive~     effects of these techniques in regards to an adequate stress management (e.g. respiration~     and heart rate variability). These findings can be found as well documented in the~     literature. For this study it is conducted to gain further insights into the role of~     mindfulness based meditation techniques for psychological well-being. Therefore it is~     intended to focus on clinical groups (e. g. depression and anxiety patients) in order to~     find out more about the relevance of mindfulness based meditation techniques as an adjunct~     for psychiatric and psychotherapeutic treatment. In this study special aspects of mental and~     spiritual health (e.g. self compassion, subjective perceived stress, spiritual well-being,~     and psychiatric symptoms) should be examined by comparing a group of clinical patients which~     practice mindfulness based meditation once a week with a control group, practicing PMR~     (progressive muscle relaxation)~   "
36563|NCT02578420|"~     To date, very little is known about the mechanisms of open-label placebo treatment and there~     is a lack in highly controlled experimental designs. Therefore, the planned project will~     test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2)~     meaning response, in an open-label placebo design, investigating their influence on placebo~     analgesia.~   "
36564|NCT02578407|"~     This study aims to determine the treatment effect of accommodative/vergence therapy on~     myopic children by assessment of accommodative function before and after therapy.~   "
36565|NCT02578394|"~     The aim of this study is to determine the feasibility of running a phase III double-blind,~     double-dummy randomised controlled trial comparing Depo-Medrone 120mg intramuscular~     injection vs. Anakinra 100mg subcutaneous injection for 5 days for the treatment of acute~     gout attacks in patients with chronic kidney disease as defined by a eGFR < 60mls/min/1.73m2~     and ≥ 30mls/min/1.73m2.~   "
36566|NCT02578381|"~     Summary of Study Aims~      To assess, in a randomised fashion:~        1. performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire~        2. performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire~        3. performance of St Jude Pressure Wire versus St Jude Pressure Wire~   "
36567|NCT02578368|"~     Previously untreated patients with limited metastatic stage (see protocol for details on~     criteria) will receive 4 cycles of FLOT (5-Fluorouracil, Leucovorin, Oxaliplatin and~     Docetaxel). Patients without disease progression will be randomized 1:1 to receive~     additional chemotherapy cycles (4-8 cycles of FLOT) or surgical resection followed by~     subsequent chemotherapy (4-8 cycles of FLOT). Main objective of the study is overall~     survival. Most important secondary objective is the quality of life under treatment and~     during follow-up.~   "
36568|NCT02578355|"~     The ultimate goal of this project is to develop a risk score to identify patients with~     vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary~     syndrome. Early identification of vulnerable plaques may have an enormous impact on public~     health through primary and secondary prevention of acute myocardial infarction.~      Investigators hypothesize that a risk score that incorporates non-invasive coronary CT~     imaging (calcium score and/or coronary CTA) in combination with clinical characteristics~     (classical risk prediction models) will improve the identification of patients who are at~     highest risk to suffer myocardial infarction or sudden cardiac death.~      The overall goal of the OPeRA project is to develop, implement and validate a novel risk~     assessment tool based on image markers and clinical characteristics to identify patients who~     are at increased risk to suffer myocardial infarction or sudden cardiac death.~   "
36569|NCT02578342|"~     The aim of the study is to investigate the response on cognitive testing of healthy persons~     compared to adults with or without medication against ADHD.~   "
36683|NCT02576860|"~     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel~     compared to vehicle gel in subjects with severe papulopustular rosacea.~   "
36572|NCT02578303|"~     Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the~     occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or~     cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per~     hour of sleep. OSA patients often report cognitive complaints.~      About 25% of the elderly population is affected by this syndrome with a drastic increase of~     this rate among dementia patients. OSAS is considered to be an important risk factor for the~     development of hypertension, heart disease and stroke.~   "
36573|NCT02578290|"~     The goal of the study is to determine whether clinical decision support (CDS) affects the~     number, type, or appropriateness of targeted high-cost radiology images (i.e. MR and CT)~     ordered. The CDS will be delivered in Epic through ACRSelect software, which is a leading~     decision support tool based on the American College of Radiology (ACR) Appropriateness~     Criteria (see http://www.acr.org/Quality-Safety/Appropriateness-Criteria), and presents the~     ACR appropriateness scores for each image on a scale of 1-9 with 1-3 labelled as 'usually~     not appropriate', 4-6 'May be appropriate', and 7-9 'usually appropriate'.~   "
36574|NCT02578277|"~     The purpose of the study is to study the effects of BMS-955176 on the single-dose PK~     parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole,~     midazolam, digoxin, and pravastatin~   "
36575|NCT02578264|"~     The study aims to provide a more complete characterization and understanding of the genetic~     causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of~     this study will be used to develop early detection tests for colorectal cancer that are~     minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive,~     early detection methods will lead to improved screening rates, increased screening safety,~     longer colorectal cancer survival, and overall cost savings.~      In order to assess the test's ability to detect tumor DNA, 25 participants with known~     colorectal cancer who will be undergoing surgical resection of the colon as part of their~     clinical care will be recruited. The investigators will collect blood from participants~     prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples~     after surgery for up to one year and relevant medical records. DNA variants identified in~     blood will be compared against tissue samples. Serial samples will be analyzed to assess the~     variance in amount of circulating tumor DNA across time with standard treatment.~   "
36576|NCT02578251|"~     The aim of this study is to assess whether paracetamol is as effective as pethidine for~     analgesia during the first stage of labor.~   "
36577|NCT02578238|"~     This study is a non-interventional, observational study of Humira® in the treatment of~     pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be~     conducted in institutions which provide a written agreement to AbbVie Korea, and where the~     use of Humira® for pediatric CD is following their normal medical practice setting.~     Pediatric patients who are prescribed Humira® as per physician's medical judgment in~     accordance with the approved Summary of Product Characteristics (SmPC) will be enrolled in~     the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product~     supply since the drug is being used according to the approved marketing label and is to be~     prescribed by the physician under usual and customary practice of physician prescription.~   "
36578|NCT02578225|"~     This study, which will be conducted at 23 sites representing the determined NUTS-1 regions~     in Turkey, in which all patients who were admitted to clinic or were hospitalized with Heart~     Failure (Acute or Chronic) diagnosis will be enrolled into the study, for a month and on a~     day of the week which will be determined by the site itself, is a national, multi-center,~     observational, epidemiological and cross-sectional study. This study is a local study which~     is planned to be conducted only in Turkey. Included patients of the study will be clinically~     evaluated by the physicians who are maintaining them and will receive the standard medical~     treatment which is determined by their physicians in normal life conditions. No experimental~     intervention or treatment will be received by patients in relation to the enrollment to this~     study. Therefore, this study does not contain a protocol or a pre-determined visit~     flowchart. However, patients with Heart Failure diagnosis should grant their consent to the~     retrospective utilization of their data and questions which will be asked to them about~     their disease history. Provided that the study's design is non-pharmacological~     observational, investigators will treat and follow the patients in accordance with their own~     medical decisions and their best clinical experiences.~      Snapshot Evaluation of Heart Failure in Turkey: Initial Analysis from SELFIE-TR~   "
36579|NCT02578212|"~     In the proposed study, investigators aim to investigate the role of interpersonal trust in~     the conditioned placebo analgesia process with healthy male subjects in a standardized~     experimental heat pain paradigm.~   "
36580|NCT02578199|"~     Motivational interviewing and nutritional counseling for weight loss in primary care.~   "
36581|NCT02578186|"~     The present study was conducted to investigate the impact of diphenhydramine hydrochloride~     on the ability to initiate sleep.~   "
36582|NCT02578173|"~     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during~     angiographic procedures. This will be a first in man prospective observational study of the~     accuracy of this system to quantify contrast volume used during clinically indicated~     angiography in the cardiac catheterization laboratory.~   "
36583|NCT02578160|"~     This will be a randomized, controlled, parallel-group clinical trial. The aim of this study~     will be to evaluate the effectiveness of Tell-Show-Do Behavior Management Technique versus~     a Conventional technique (covering the patient's vision) during an inferior alveolar and~     lingual nerve block in preschool children referred for treatment at the School of Dentistry,~     University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to~     5 years 11 months old who need dental pulp treatment and / or tooth extraction of primary~     molars. Preschool children with no history of allergies to Lidocaine anesthetic or~     systemic/neurological diseases and who did not take local anesthesia before the study will~     be include in this research.~   "
36630|NCT02577549|"~     This study aims to develop and demonstrate the effectiveness of a systematic, practical,~     cost-effective diet-induced weight loss and exercise intervention in both urban and rural~     communities that can reduce pain and improve other clinical outcomes in knee OA patients.~     This pragmatic community-based trial will determine if the investigators previous findings~     translate to real-world settings and will address common concerns about barriers to~     effectiveness/ implementation.~   "
36584|NCT02578147|"~     The purpose of this study is to have girls play new computer games designed for middle~     school children and not yet available to the public. The investigator wants to know what~     girls think about these games. The investigator also wants to learn about the health~     behavior of 7th grade girls of Hispanic/Brazilian/Latino origin, and the investigators want~     to test the Mighty Girls program in Miami. Half of the girls in JUEGA will be given the~     Mighty Girls program and the investigators want to know if this program reduces behavior~     that puts girls at risk for having sex, drinking, and using drugs. The program tries to~     reduce this risk by helping girls learn skills to make wise choices, even when their friends~     have other ideas or want them to make more risky choices This goal is important because US~     statistics indicate that Hispanic teens are at risk for teen pregnancy and Miami has one of~     the highest HIV and AIDS rates in the United States. The investigator wants to find out~     whether the Mighty Girls program is as effective in Miami-Dade County Public Schools as it~     was when tested in one of Orlando's Orange County Public Schools.~   "
36585|NCT02578134|"~     Scientific evidence of conservative management of individuals with plantar fasciosis is~     sometimes conflicting. There is evidence that regular exercise programs are effective for~     this pain condition. The inclusion of other therapeutic modalities is still controversial.~     Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe~     useful for the management of chronic tendinopathies; however, no study has investigated the~     potential placebo effect of this intervention. The objective of this randomized clinical~     trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus~     sham US-guided percutaneous electrolysis for the management of patients with plantar~     fasciosis for pain, function, and disability.~   "
36586|NCT02578121|"~     The purpose of this study is to determine the efficacy of Ixazomib when combined with~     Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed~     Multiple Myeloma~   "
36587|NCT02578108|"~     Chronic painful knee OA is a major cause of disability in older adults. In patients whose~     symptoms are refractory to conservative management but who do not wish to undergo TKA or,~     alternatively, are not operative candidates, genicular nerve RFA represents a promising~     treatment option.~      Investigators will determine if patients with chronic painful knee osteoarthritis experience~     meaningful and long-term improvement in pain, function, and analgesic use, as well as~     prevention of TKA after RFA of the genicular nerves. Investigators will also determine~     whether zero versus one set of diagnostic genicular nerve blocks~      Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile~     treatment for chronic painful knee OA. Additionally, this will help determine the optimal~     diagnostic protocol for patient selection for this procedure, which has implications for~     improving treatment success rates, preventing unnecessary procedures, and decreasing~     healthcare cost savings.~   "
36588|NCT02578095|"~     This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to~     investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.~      Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will~     be eligible for participation 3-7 weeks post-injury.~   "
36589|NCT02578082|"~     This multiple-center, nonrandomized, open label, parallel group, single dose study will be~     conducted in male and female subjects with normal renal function or severe (eGFR <30~     mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the~     pharmacokinetics (PK) of TD 4208.~   "
36590|NCT02578069|"~     Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting~     stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology~     centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.~   "
36591|NCT02578056|"~     Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It~     implies physical, psychological and social losses. A frequent complication after surgeries~     for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar~     pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a~     prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary~     incontinence (OUI) is considered the major risk factor for postoperative SUI. Studies on~     this topic show conflicting results. In a recent meta-analysis on this subject, Maher et al~     concluded that the value of performing any anti- incontinence procedure in continent women~     undergoing prolapse surgery remains unknown.~      The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®)~     in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and~     if it implies an improvement in their quality of life. The secondary endpoints are to assess~     the complications associated with this procedure, as irritative symptoms and voiding~     dysfunction postoperatively and assessing the ability of stress testing with reduced POP and~     urodynamics in predicting the risk of de novo SUI. This study will be a prospective,~     multicentric, randomized experimental study.~      Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to~     participate in the study. The study will assess these patients for staging of prolapse, the~     presence of occult urinary incontinence and quality of life. Selected patients will be~     randomized to perform correction of genital prolapse and prophylactic anti-incontinence~     procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12~     months after surgery. Postoperative evaluation will be similar to preoperative. The~     exclusion criteria are: complaint or diagnosis of stress urinary incontinence before~     reduction of the prolapse, previous surgery for incontinence or pelvic organ prolapse,~     hypocontractility detrusor in urodynamics and inability to understand and give informed~     consent.~   "
36592|NCT02578043|"~     The objectives of this study are to evaluate the therapeutic equivalence and safety.~   "
36593|NCT02578030|"~     To provide additional, required information on the pharmacokinetic profile of SHP465 in the~     targeted population (children and adolescents aged 6-17 years of age with ADHD).~   "
36594|NCT02578017|"~     HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU~     can reduce SCD related symptoms, but only 50% of patients take it as often as they should.~     This limits how much HU can help reduce SCD symptoms.~      Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a~     program that uses cell phone reminder messages, videos, feedback messages, and incentives~     will help patients with SCD take HU as prescribed.~   "
36595|NCT02578004|"~     Development of pressure ulcer (PU) is complex and multifactorial. The association of a~     constituted PU and of clinical / biological major elements is demonstrated and justifies.~     Prevention of PU is an important health priority, one that requires clear identification of~     risk factors.~   "
36596|NCT02577991|"~     Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia~     compared to intravenous steroids or a control group~   "
36597|NCT02577978|"~     The purpose of this study is to compare objective and subjective measures of knee stability~     following total knee arthroplasty with a medial pivot design vs. a posterior stabilized~     design.~   "
36598|NCT02577965|"~     Recent studies suggest important gender differences in the pathophysiology and prognosis of~     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled~     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus~     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related~     mechanisms of plaque rupture or erosion will be investigated using a combination of~     Quantitative Coronary Angiography (QCA), high resolution Optical Coherence Tomography (OCT)~     of the culprit vessel and histopathology analyses of thrombus aspirates of the infarct~     related lesion, performed by independent core laboratories, blinded to group (male or~     female) and clinical variables.~      In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a~     computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years).~     Matching has the purpose to enable enrollment of an even number of male and female patients~     in balanced age groups. This type of dynamic algorithm is appropriate when the composition~     of the referral population is not known in advance.~      The sample size for the OCTAVIA study was calculated on the basis of per patient stent strut~     coverage (a continuous variable with right skewed distribution) with mean of 97.0% and~     standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in~     women, following XIENCE PRIME™ Everolimus Eluting Coronary Stent System implantation. Thus,~     aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment~     according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10%~     dropout rate due to patients lost to follow-up and inadequate imaging (included major side~     branch sections), the total enrollment is set at 70 patients per group (total population of~     140 subjects).~   "
36599|NCT02577952|"~     Lipodystrophy Connect is an online survey tool designed to collect demographic data and~     health information from individuals with Lipodystrophy.~   "
36600|NCT02577939|"~     The primary objective of this study is to demonstrate the efficacy of a pre-transplant,~     interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak)~     scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is~     feasible in this population. Secondary objectives include documenting the safety of IET in~     this population, evaluating the correlation of VO2peak with other methods of measuring~     pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD)~     pre and post IET, and establishing the feasibility of the 6MWD when performed unsupervised~     by a health care professional.~      Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full~     intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise~     intervention by their treating physician. The investigators will enroll no more than 50~     patients onto this trial. Results of this study will inform a randomized, multi-site study~     of a pre-transplant exercise intervention.~   "
36601|NCT02577926|"~     The Philadelphia chromosome negative myeloproliferative neoplasms (MPN) comprise a group of~     clonal hematological malignancies that are characterized by chronic myeloproliferation,~     splenomegaly, different degrees of bone marrow fibrosis, and disease-related symptoms~     including pruritus, night sweats, fever, weight loss, cachexia, and diarrhea. In addition,~     due to elevated numbers of leucocytes, erythrocytes and/or platelets, the disease course can~     be complicated by thromboembolic disease, hemorrhage, and leukemic transformation as well as~     myelofibrosis.~      Patients with polycythemia vera (PV) typically harbor an increased number of blood cells~     from all three hematopoietic cell lineages due to clonal amplification of hematopoetic stem~     cells, while patients with essential thrombocythemia (ET) typically show a predominant~     expansion of the megakaryocytic lineage. Most patients with PV below the age of 60 years are~     currently being treated with acetylsalicylic acid +/- phlebotomy only, and patients with~     low-risk ET have an almost normal life expectancy and often do not require specific~     treatment. However, PV- as well as ET-patients with a higher risk for complications require~     cytoreductive treatment. In addition, constitutional symptoms can be unbearable to patients~     even in the absence of bona fide high risk factors, and these patients may similarly benefit~     from antineoplastic therapy.~   "
36602|NCT02577913|"~     This study compares the risks of short- and long-term use of FC Patch Low with~     levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population~     representative of the actual users of the individual preparations. FC Patch Low is a~     transdermal contraceptive patch applied once a week for three consecutive weeks followed by~     a break of one week (21/7). One patch contains 2.1mg gestodene and 0.55mg ethinyl estradiol,~     which is equivalent of releasing 0.06mg gestodene and 0.013mg ethinyl estradiol per 24~     hours.~   "
36603|NCT02577900|"~     The purpose of this study is to determine whether nanocrystalline silver dressing, manuka~     honey dressing and conventional dressing are effective in the treatment of diabetic foot~     ulcer.~   "
36604|NCT02577887|"~     The purpose of this study is to characterize the utilization of diagnostics capabilities in~     St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing~     indication.~   "
36605|NCT02577874|"~     This study is designed to compare the responses to an oral glucose challenge between people~     of European and Chinese heritage (essential participants in the European arm must have tow~     European parents and likewise for the Chinese participants).~   "
36606|NCT02577861|"~     The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first~     treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency)~     secondary to ocular burns. In case of failure of the treatment and upon clinical indication~     of the Principal Investigator, a second transplant with Holoclar will be offered if~     eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year~     after the last treatment will be also evaluated. All patients will be followed-up for 12~     months after each implant to determine the treatment efficacy by an Independent Assessor.~   "
36607|NCT02577848|"~     The investigators planned to evaluate the effects of liraglutide on left ventricular~     function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).~   "
36617|NCT02577718|"~     The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of~     a non- antibiotic chelator based lock solution that contains nitroglycerin in combination~     with sodium citrate and ethanol (NiCE lock solution) for prevention of central line~     associated bloodstream infection (CLABSI).~        -  The primary objective of this study is to evaluate the safety and estimate the rate of~          adverse events associated with the NiCE lock solution.~        -  The second primary objective is to estimate the rate of CLABSI in patients receiving~          the NiCE lock solution.~   "
36656|NCT02577211|"~     The aim of this study is to compare two nutritional regimes in critically ill patients.~     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition~     (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA~     (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic~     diet decreases the incidence of organic failure in these patients.~   "
36608|NCT02577835|"~     This Registry is an investigator-initiated, international, multicenter, observational,~     prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and~     arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects;~     ii) assessing the changes in estimates following treatment; iii) weighing the impact of 24-h~     pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the~     relationship between arterial stiffness, blood pressure absolute level and variability, and~     prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine~     diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will~     include ambulatory blood pressure monitoring, performed with a device allowing simultaneous~     non-invasive assessment of blood pressure and arterial stiffness, and clinical data~     (including cardiovascular outcomes). A web-based telemedicine platform will be used for data~     collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results~     are expected to be available in the next 2-years. The results of the Registry will help~     defining the normalcy thresholds for current and future indices derived from 24-h pulse wave~     velocity, according to outcome data. They will also provide supporting evidence for the~     inclusion of such evaluation in recommendations on hypertension management.~   "
36609|NCT02577822|"~     The purpose of this study is to determine the viability of short femoral stems as an~     alternative to standard-length stems in total hip arthroplasty.~   "
36610|NCT02577809|"~     This is an interventional drug trail to evaluate the effect of different intrathecal opioids~     on post-operative pain experiences in women who have undergone caesarean section surgery.~   "
36611|NCT02577796|"~     Radial artery access is increasingly becoming popular among interventional cardiologists for~     patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography~     secondary to its low complications rates. However, it is frequently associated with the~     spasm of the radial artery which can lead to difficulty in catheter manipulation during the~     procedure and potentially leading to vessel trauma. This vessel trauma can cause activation~     of coagulation system and formation of clot and subsequently the occlusion of radial artery.~     In this study the investigators intend to find the association of radial artery spasm with~     the future development of radial artery occlusion in patients who undergo PCI via radial~     access.~   "
36612|NCT02577783|"~     The purpose of this study is to determine whether doxorubicin hydrochloride liposome is~     superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient~     with initially diagnosed multiple myeloma.~   "
36613|NCT02577770|"~     This is a single center, double blind, randomized, parallel-group study to assess the effect~     of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human~     pain model.~   "
36614|NCT02577757|"~     Proceed to an analysis of sensitivity and specificity results of the fMRI language network~     obtained in two ways: by providing a conventional language test and independent component~     analysis. These two methods will be compared to the reference method what the cortical~     intraoperative mapping.~   "
36615|NCT02577744|"~     Obesity is a non-communicable chronic disease of multifactorial, involving biological,~     historical, ecological, economic, social, cultural and political. Currently, bariatric~     surgery is considered an effective method of refractory obesity treatment, and only severe~     obesity effective treatment that leads to reduced long-term weight. It is well documented in~     the literature regarding the association of abdominal surgery and the incidence of~     respiratory complications and its main characteristics are: atelectasis, pneumonia,~     respiratory dysfunction and pleural effusion. All these respiratory complications can be~     minimized or avoided with the use of a respiratory therapy care protocol, since the~     pulmonary atelectasis is considered the main cause of complications. An arsenal of resources~     to physical therapy lung expansion, among these, the application of positive pressure~     through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive~     ventilation, and aims to prevent and / or improve the complications resulting from~     postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment~     of the respiratory system, without suffering the same interference conditions of patients,~     such as pain and bed rest. TIE consists of a method that measures passively regional lung~     ventilation. The aim of this study is to compare the effects of the application of EPAP and~     NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled~     trial where patients will be divided into two groups: EPAP and NIV and assessed by~     spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd~     postoperative day where they will be evaluated before, during and after the application of~     the techniques.~   "
36616|NCT02577731|"~     Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains~     a substantial economic and health care burden. Despite decades of promising preclinical and~     clinical investigations in trauma, investigators understanding of these entities is still~     incomplete, and few therapies have shown success. During severe trauma, bone marrow~     granulocyte stores are rapidly released into the peripheral circulation. This release~     subsequently induces the expansion and repopulation of empty or evacuated space by~     hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone~     marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation~     of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is~     critical for the survival of the severely traumatized and further, failure of the emergency~     myelopoietic response is associated with global immunosuppression and susceptibility to~     secondary infection. Also, identifying the release of myeloid derived suppressor cells~     (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs~     in the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the~     nutritional status of the host. The appearance of these MDSCs after trauma is associated~     with a loss of muscle tissue in these subjects. This muscle loss and possible increased~     catabolism have huge effects on long term outcomes for these subjects. It is the~     investigator's goal to understand the differences that occur in these in HSCs and muscle~     cells as opposed to non-injured and non-infected controls. This work will lead to a better~     understanding of the myelopoietic and catabolic response following trauma.~   "
36684|NCT02576847|"~     This study evaluates the long-term safety of once-daily application of Omiganan topical gel~     in subjects with severe papulopustular rosacea.~   "
36618|NCT02577705|"~     The goals of the The Building Wealth and Health Network (The Network) are to develop and~     rigorously test an asset building model that will build financial, social and human capital~     through asset building, financial education and trauma-informed peer support. Program~     components include: 1) Matched savings accounts; 2) Financial literacy classes; and 3) Peer~     support groups using the Sanctuary ® trauma-informed approach to social services. This~     program is offered in partnership with the Department of Public Welfare of the Commonwealth~     of Pennsylvania. The program elements will fulfill work requirements for the program called~     temporary Assistance for Needy Families (TANF).~      The hypothesis is that the program's combination of services will result in improved~     economic security through boosting income, increasing assets, and building a supportive~     social network, that then translates to better health outcomes.~   "
36619|NCT02577692|"~     High inspiratory oxygen fractions are known to induce oxidative stress and lipid~     peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in~     part volatile and appear in breath where they can be measured non-invasively. However, there~     is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.~      This study aims to investigate the effects of a high inspiratory oxygen fraction on~     oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled~     breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass~     spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and~     their relationship to breath biomarkers.~   "
36620|NCT02577679|"~     The aim of this case control study is to explore the possible association between~     periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.~   "
36621|NCT02577666|"~     A dearth of information is available regarding how best to intervene with substance use~     disordered homeless mothers and their young children. This proposal follows from the~     promising findings of a rigorously developed ecologically based treatment that offers a~     comprehensive intervention for the multiple needs of this vulnerable population. Such~     research attention is needed in order to effectively intervene in the substance use, HIV~     risk, mental/physical health and homeless trajectory of these women and their young~     children. Further, if successful, this intervention may be transportable to communities~     without crisis shelters and to homeless mothers who do not access shelter or residential~     treatment services.~   "
36622|NCT02577653|"~     Determine the posturographic characteristics of eccentric, isometric and concentric~     movements in healthy subjects as well as in subjects with chronic, orthopedic conditions /~     pain not involving the lower extremities. The squatting movement (going down from a stand up~     position, bending the ankle, knee and hip joints, and then returning to the stand up~     position, while not lifting the feet from the supporting ground surface) is a simple motion~     that involves all three types of movements: eccentric (the going down), isometric (holding~     the down position for a couple of seconds) and concentric (the coming up). It is~     hypothesized that non-healthy subjects will not have smooth movements, and posturography~     could be used to separate between healthy and non-healthy subjects.~   "
36623|NCT02577640|"~     Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects~     of Food Innovation Science on Gastrointestinal Disease~   "
36624|NCT02577627|"~     This is a retrospective observational, open label study to evaluate and prospectively~     validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in~     individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer,~     Castration-Resistant Prostate Cancer, Breast Cancer & Colon Cancer under the treatment with~     the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the~     market as a Standard of Care~   "
36625|NCT02577614|"~     The purpose of this pilot study is to evaluate the feasibility of the prophylactic~     administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of~     cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to~     demonstrate the potential role of FEIBA administration in reducing the need for allogeneic~     transfusion to treat refractory coagulopathy in high risk patients.~   "
36626|NCT02577601|"~     The purpose of this research study is to determine if taking a birth control pill effects~     how well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of~     emergency contraceptive is the most effective oral method available. However, this~     medication is an anti-progestin and most regular forms of birth control contain progestin (a~     female hormone). It is unknown if taking the two close together may make the emergency~     contraceptive not work well. The overall goal of this research is to improve the~     effectiveness of contraception for women and to better counsel women.~   "
36627|NCT02577588|"~     The study Phase I trial of Adoptive T cell Therapy with Activated P53 specific T cells for~     Treatment of Advanced Colorectal Cancer is an open label, single arm trial.~   "
36628|NCT02577575|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether~     intranasal oxytocin administration can serve as an adjunct treatment for social impairments~     in schizophrenia.~      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in~     patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition~     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved~     in emotional or sarcastic communication) after administration of oxytocin versus placebo.~      Hypothesis B: Patients and healthy comparison subjects will show increased attention to~     others' eyes and patients will exhibit increased facial affect expressivity after~     administration of oxytocin versus placebo.~      Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in~     schizophrenia (PNS) activity in patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS~     activity during social tasks after administration of oxytocin versus placebo.~      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social~     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS~     activity.~   "
36629|NCT02577562|"~     The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation~     approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA~     Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.~   "
36631|NCT02577536|"~     PregSource uses a crowd-sourcing approach, asking pregnant women to enter information~     regularly and directly about their pregnancies throughout gestation and the early infancy of~     their babies into online surveys and trackers via a website and/or mobile application~     (app). In exchange, participants can track their data over time, print out reports to~     share with their healthcare team, and see how they compare to other women. In addition,~     PregSource will provide participants with links to trusted, evidence-based information about~     pregnancy management, issues, and complications.~   "
36632|NCT02577523|"~     This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects~     with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC~     infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as~     a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will~     undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient~     treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of~     ND0612H continuous SC infusion. Subjects will then continue on a maintenance dose of the~     assigned ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4~     weeks after the last SC administration of the study drug for a total of about 2.5 months of~     participation for each subject enrolled into the trial.~   "
36633|NCT02577510|"~     Background~      The sensation on the outside of portion of our thighs is provided by a nerve called the~     lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the~     nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of~     the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee~     surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the~     LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in~     military and police personnel [4]. Although generally a benign condition, compression or~     injury to this nerve can be painful and require treatment. In addition, the actual~     variability in sensory distribution for this nerve has not been elucidated in a~     topographical fashion and will be measured in this study.~      Finding the most efficient and effective method for anesthesia of the LFCN can improve and~     positively impact the quality of pain control for patients. Ultrasound has improved the~     accuracy and efficiency of various other regional anesthesia techniques, and could also~     impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral~     femoral cutaneous nerve block using the subinguinal technique will be statistically more~     efficacious and efficient when compare to neurostimulation based blockade.~   "
36634|NCT02577497|"~     The primary objective of the study is to show that ventilation heterogeneity identified by~     hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite~     guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or~     not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation~     heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry~     powder).~   "
36635|NCT02577484|"~     This study will assess the differences between Fractional Flow Reserve (FFR) measurements~     made by the Navvus catheter and a commercially available pressure guidewire in up to 240~     subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment~     according to clinical indications and center standard practice.~   "
36636|NCT02577471|"~     In this prospective study the function of gastrointestinal tract was assessed using~     constipation questionnaire (Rome criteria and bowel function index).~   "
36637|NCT02577458|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability,~     Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in~     Chinese Patients With Advanced Renal Cell Carcinoma.~   "
36638|NCT02577445|"~     The aim of this post market study is to assess the impact of sleep-disordered breathing on~     the well-being of patients according to the treatment chosen, i.e. with or without~     implantation of the remedē® system to treat sleep-disordered breathing.~   "
36639|NCT02577432|"~     Background: Poor spinal anaesthesia block is common and is difficult to manage; so a~     technique to minimize its incidence is advisable. Hypotension is the commonest problem with~     spinal anesthesia. Multiple trials to prevent or combat hypotension using positional~     changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and~     mode of administration as either bolus or infusion is still a matter of debate.~      Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and~     fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.~      Design: A randomized, controlled clinical trial.~      Setting: Single medical center from 5/2013 to 10/2014.~      Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were~     randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia~     using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S~     received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a~     second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was~     started as fast drip during, and continued after spinal anesthesia.~      Patients were monitored for hemodynamic parameters, time of sensory onset and height of~     maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and~     the frequency of side effects.~   "
36640|NCT02577419|"~     Breast milk is the reference normative standard for infant feeding. When an infant is~     diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to~     the presence of long chain triglycerides (LCT) that contribute to persistent chylous~     drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain~     triglycerides (MCT) as treatment for chylothorax. Families and health care providers are~     interested in using breast milk, in a modified fat form, as treatment for chylothorax~     instead. This study will assess growth in infants receiving one of two nutrient enriched~     modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed~     nutrient enrichment methods support growth, MFBM will become a standard chylothorax~     treatment option for infants at SickKids.~   "
36641|NCT02577406|"~     This is an international, multicenter, open-label, randomized, Phase 3 study comparing the~     efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years~     or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or~     third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.~   "
36642|NCT02577393|"~     The investigators conducted this phase II study of EGCG therapy protection of the esophagus~     from damage induced by radiotherapy. In order to observe the effectiveness of EGCG,~     esophageal toxicity was recorded weekly using a grading scale based on symptomatology,~     following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain~     related to esophagitis was measured using the numerical rating scale (NRS) every week from~     EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into~     Chinese and guides in Chinese are developed instructing how to use the scales and perform~     the assessments.~   "
36643|NCT02577380|"~     The overarching goal of this study is to pilot an approach to HIV testing and counseling~     (HTC) that addresses intimate partner violence. The results of the study will fill an~     important gap in the literature and contribute to efforts by Kenyatta National Hospital in~     Nairobi, Kenya—and the HIV and sexual and reproductive health field globally—to better~     address intimate partner violence in our work.~   "
36644|NCT02577367|"~     The study aims to describe the changes in Levothyroxine dosage requirements in patients with~     hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty~     stomach affects the mean percentage increase expected in Levothyroxine dosage in these~     patients.~   "
36645|NCT02577354|"~     The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the~     treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in~     conjunction with medical management.~   "
36646|NCT02577341|"~     This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in~     combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.~   "
36647|NCT02577328|"~     The assessment of pain management in Internal medicine department.~   "
36648|NCT02577315|"~     Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets~     compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy~     male and female volunteers under fed conditions~   "
36649|NCT02577302|"~     As a screening evaluation, all subjects will have a needle placed transcutaneously at the~     baseline visit to confirm that the subject feels a pulsation on the foot or toes with or~     without flexion of one or more of the toes. This motor nerve test demonstrates that the~     nerve is responsive to stimulation as an indicator that the subject is an eligible candidate~     for both PTNS and CAN-Stim therapies.~      Subjects will be randomized to either CAN-Stim or PTNS after eligibility is determined from~     the screening test.~   "
36650|NCT02577289|"~     Evaluation of bone quantity in open sinus lift technique with space maintaining using~     platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline~     hydroxyapatite with simultaneous placing of implants.~   "
36651|NCT02577276|"~     Is a unique tele-rehabilitation service directed at treating upper limb weakness due to~     stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the~     clinicians providing the care satisfied with the process?~   "
36652|NCT02577263|"~     The primary objective of this trial is to determine the impact of the FOLFOX regimen on~     quality of life and the incidence of chemotherapy induced neurotoxicity.~   "
36653|NCT02577250|"~     The relationship between depression and trauma is well established. Co-occuring depression~     and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower~     levels of functioning. Veterans with both depression and PTSD have been shown to be at much~     higher risk of suicide than individuals with only one of these disorders. Ketamine has been~     shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms.~     The purpose of this study is to see whether ketamine, when given as repeated infusions, can~     produce quick and sustained improvement in depression and PTSD symptoms for individuals who~     have not had their symptoms effectively treated by current treatments.~   "
36654|NCT02577237|"~     Patients with head and neck cancer and their caregivers face many challenges. These include~     learning about cancer and its treatment, coping with symptoms from illness and treatment~     side effects, making adjustments to usual activities, and managing the emotional effects of~     having a serious illness. This study tests whether different forms of education and support~     can help family caregivers feel better prepared. To find out if education about caregiving~     and different kinds of support are effective, this study wants to compare approaches.One~     group includes caregivers who will receive an education and support program throughout~     radiation treatment in addition to usual care by their doctors and nurses. The other group~     receives an educational booklet about caregiving in addition to usual care by their doctors~     and nurses. The caregiver also completes surveys about his or her emotions, distress,~     confidence as a care giver, and quality of life. In addition, the study asks the caregiver~     questions about his or her age, race, ethnicity, marital status, employment status,~     education, annual household income, and current living arrangements. This pilot study will~     only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case~     Comprehensive Cancer Center Main Campus.~   "
36655|NCT02577224|"~     Blepharospasm and hemifacial spasm are debilitating conditions which significantly impact on~     patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary~     relief but the duration of treatment efficacy is variable. The standard model of patient~     care defines routine fixed- time based scheduled treatment cycles which may lead to~     unnecessarily frequent treatment for some patients and experience of distressing symptoms in~     others if symptoms return before the scheduled follow up period. The present study aims to~     compare a patient-initiated model of care, where patients determine treatment timing, with~     the standard model of care by using a two-arm randomised controlled trial design. It is~     expected that patients able to initiate their own treatment will experience less variation~     in disease severity and disability over a treatment cycle as they will be empowered to take~     the initiative when they feel they need to have treatment. A range of other outcomes will be~     assessed including: confidence and satisfaction in the service, depression, anxiety, quality~     of life and, illness and treatment beliefs. If the patient-led care model is shown to be~     effective in preventing distress and reducing disability in these populations; and is found~     to be acceptable to service users, this will have significant implications for service~     organisation across the NHS.~   "
36696|NCT02576691|"~     The purpose of this study is To assess percutaneous coronary intervention 's effect on~     short- and long- term outcomes, and complication incidence in resuscitated victims of~     cardiac arrest after acute myocardial infarction~   "
36657|NCT02577198|"~     Computerized decision support systems (CDSSs) are information technology-based software that~     provide health professionals with actionable, patient-specific recommendations or guidelines~     for disease diagnosis, treatment, and management at the point-of-care. CDSSs may be~     integrated with patient electronic health records (EHRs) and evidence-based knowledge.~   "
36658|NCT02577185|"~     The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum~     toxin type A compared to that of injected vehicle.~   "
36659|NCT02577172|"~     The present study examine the effects of an aerobic and strength training program on~     cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of~     the participants will receive the exercise program and the other half will receive one~     individual lifestyle counseling session. The investigators hypothesize that TC patients in~     the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy~     treatment compared to patients in the control group.~   "
36660|NCT02577159|"~     The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein~     metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus~     whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will~     examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C~     before and after the 8 weeks administration of dapagliflozin.~   "
36661|NCT02577146|"~     This is a single institution, prospective study to evaluate the prognostic significance of~     renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the~     spontaneous stone passage rate of ureteral stones.~   "
36662|NCT02577133|"~     Colic is a term for inconsolable crying happened in the first months of life. Its etiology~     is multifactorial and caregiver and pediatrician generates among other problems: anxiety,~     risk of child abuse as well as economic costs.~      There is now enough evidence for the treatment of colic using probiotics, especially~     Lactobacillus reuteri.~      The investigators study aims to demonstrate the utility for the prevention of colic with L.~     reuteri and thereby avoid the problems caused by this pathology.~      Objective: Compare the number of events of colic among infants with oral probiotic~     Lactobacillus reuteri during the first month of life versus infants with placebo~      Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age,~     breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28~     days. The investigators trial will be performed at Naval Hospital in Mexico City.~   "
36663|NCT02577120|"~     This prospective pilot study is to enroll patients with clinically-defined infected wounds.~     Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A),~     and will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound~     patients will be recruited for this study in Phase A. Based on the expectation that 89% of~     these wounds will heal within 16 weeks of enrollment, 234 of these patients will continue~     with the study for Phase B.~   "
36664|NCT02577107|"~     This prospective, randomized, open label study will enroll patients with neovascular AMD who~     are naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the~     previous 3 months. Patients will be randomized in two treatment arms for 3 months:~        -  Study arm 1: Three monthly injections of 0.5mg Ranibizumab~        -  Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum)~          will be collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28,~          following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff will be~          blinded for treatment allocation.~      Plasma VEGF concentration will be measured by a blinded laboratory using Quantikine® ELISA~     kits. Serum ranibizumab and conbercept concentration will be determined using validated~     ELISA assay.~      The study will be divided into 2 stages: the 1st initial feasibility stage with 6 patients~     per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to~     confirm the findings with justified sample size.~   "
36665|NCT02577094|"~     Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab~     radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen~     FB2A2 before allogeneic stem cell transplantation.~   "
36666|NCT02577081|"~     Neck of femur fractures are common in the elderly and are the source of significant~     morbidity and mortality. This study is based on a new technique developed in Ben Gurion~     University, with which investigators are able to asses the structural 3 dimensional strength~     of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this~     study is to evaluate the risk of a contralateral neck of femur fracture after the first neck~     of femur fracture and to estimate the potential fracture characteristics.~   "
36667|NCT02577068|"~     Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior~     neck pain because of neck extension position during the surgery. However, there has been~     little attention of posterior neck pain. Nefopam and Propacetamol have different~     pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The~     aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute~     wound pain, posterior neck pain and chronic pain after thyroidectomy.~   "
36668|NCT02577055|"~     Purpose of this study:~      To establish the equivalence of poly-myomectomy versus Uterine Artery Embolization, in women~     with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.~   "
36681|NCT02576886|"~     Participants are being asked to participate in this research study because the participant's~     doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography)~     scan to look at the blood flow in the participants heart.~      Myocardial perfusion imaging is a proven test that looks at the blood flow to the~     participant's heart after the injection of a radioactive tracer. The standard test requires~     two injections of the radioactive tracer and takes images of the participant's heart at rest~     and after a stress test. It has been proposed that in some cases, patients could have images~     done only after the stress portion of the test and, if normal, the rest images would not~     need to be done. In this case, only one injection of the radioactive tracer would be needed.~     It has further been proposed that adding another stress image made with the participant~     lying on their stomach, will increase the confidence of the reporting doctor in reporting~     stress images.~      The purpose of this study is to find out if the extra information added from the image with~     the participant on their stomach helps the doctor when reporting the test results.~   "
36669|NCT02577042|"~     Physicians in charge of HIV-infected patients are increasingly being faced to previously~     unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of~     renal function, osteopenia/osteoporosis and bone fractures or non-AIDS-defining cancers~     (1-4). The incidence of these conditions seems to be higher than in the general population~     but there are controversial data about if these diseases appear at a younger age in~     HIV-infected patients.~      The investigators propose a strategy for treatment of elderly HIV-infected patients with a~     double impact on systemic inflammation and age-related co-morbidities by switching the~     protease inhibitors by raltegravir, a integrase inhibitor with a neutral effect on lipid and~     bone metabolism, and adding an statin because of their anti-inflammatory effect. For safety~     reasons, only patients with maintained viral suppression (documented indetectable viral load~     for 1 year or more), and no history of virological failure to integrase inhibitors or~     suspected or documented resistance mutations to the integrase or retrotranscriptase will be~     candidates for the study.~      Interleukin -6 and D-dimer are biomarkers that most strongly predict mortality in treated~     HIV infection and sCD14, sCD163 are soluble markers of monocyte activation that reflect a~     key source of inflammation and coagulation in HIV infection and predict mortality (26,27).~     For that reasons, these markers were chosen to determine changes on them after the~     introduction of the statin and the change of antiretrovirals~   "
36670|NCT02577029|"~     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 alone or~     ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF)~     and/or pegylated interferon alpha 2a (PEG IFN) therapy, and be evaluated for safety and~     efficacy.~   "
36671|NCT02577016|"~     This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese~     participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on~     ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the~     addition of sitagliptin once daily compared with placebo provides greater reduction in~     hemoglobin A1C (HbA1C) as assessed by change from baseline (Week 0) to Week 24.~   "
36672|NCT02577003|"~     This is a study to assess the safety and efficacy of the addition of ipragliflozin once~     daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate~     glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this~     study is that the addition of ipragliflozin compared with placebo provides greater reduction~     in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.~   "
36673|NCT02576990|"~     In this study, participants with relapsed or refractory primary mediastinal large B-cell~     lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive~     pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS~     will be evaluated.~   "
36674|NCT02576977|"~     The purpose of this study is to compare the efficacy of pomalidomide and low dose~     dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose~     dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in~     participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have~     undergone at least 2 lines of prior treatment.~   "
36675|NCT02576964|"~     This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination~     with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had~     no prior treatment. The anticipated time on study treatment is until disease progression,~     and the target sample size is 43 individuals.~   "
36676|NCT02576951|"~     The purposes of this study are:~        -  To evaluate tolerability of the LY2951742 solution injectable formulation (Part A)~        -  To measure how much of the LY2951742 lyophilized (freeze dried) injectable formulation~          is absorbed into the blood stream and how long it takes the body to get rid of it~          compared to the LY2951742 solution injectable formulation after a single injection~          under the skin (subcutaneous [SC]) (Part B).~      Information about any side effects that may occur will also be collected. Each part of the~     study will last about six months. Participants may only enroll in one part.~   "
36677|NCT02576938|"~     The purpose of this study is to evaluate the safety and effectiveness of baricitinib in~     eczema.~   "
36678|NCT02576925|"~     The transient diplopias (TD) is defined by a short diplopia. Their etiology may be~     ophthalmological, neurological non-ischemic or of ischemic origin.~      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.~      A clinical score could help the clinician to recognize the etiology of the TD .~   "
36679|NCT02576912|"~     The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the~     acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will~     be tested by pretreating healthy individuals with PREG and then assessing their responses to~     THC.~   "
36680|NCT02576899|"~     Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population)~     and have substantial difficulties with quitting tobacco. Only 23% of individuals with PTSD~     quit smoking compared to 50% of the general population. As a result, Veterans with PTSD are~     at high risk of developing severe health problems and poor physical functioning. Fifty~     percent of these long-term smokers will die of a smoking-related cause and on average, will~     lose 25 years of their life compared to non-smokers. Despite the significant morbidity and~     mortality associated with smoking, no smoking cessation treatments exist that intensively~     target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier~     to quitting for many Veterans. In addition, no smoking cessation treatments have a large~     emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although~     both PTSD and tobacco use negatively affect functioning across physical, mental health, and~     social domains.~      The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans~     with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking~     cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically~     targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to~     difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during~     quit attempts. ACT-PT includes structured intervention components that guide Veterans to~     replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping~     strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in~     work, expanding social networks, engaging in physical exercise) that are consistent with~     Veterans' values. This emphasis on substantially improving health-related quality of life~     and functioning across several areas makes ACT-PT particularly innovative and different from~     existing treatments. However, research is needed on the relative feasibility, acceptability,~     and efficacy of ACT-PT compared to standard smoking cessation treatments.~      The proposed SPiRE (I21) will involve a randomized clinical trial study of 50 Veteran~     smokers with PTSD and tobacco dependence randomized to one of two different types of~     psychosocial treatment 10 individual sessions of ACT-PT (n= 25) versus 10 individual~     sessions of the American Lung Association's Freedom From Smoking Program [FFS] (n=25) with~     all participants receiving 12 weeks of the nicotine patch. This study has two primary aims:~     1) evaluate the relative feasibility and acceptability of the two interventions (including~     ease of recruitment, randomization proportion, staff and Veteran acceptance of the~     treatment, retention rates, treatment adherence, fidelity, ease of the assessment process),~     and 2) evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of~     tobacco use, PTSD symptoms, health-related quality of life, and functional impairment.~   "
41217|NCT02517502|"~     The purpose of this study is to determine if a high dose of DHA begun prior to and continued~     during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent~     or lessen chemotherapy induced cognitive dysfunction.~   "
36685|NCT02576834|"~     The literature is characterized by a dearth of information on interventions for homeless~     youth, and no suicide prevention intervention has been tested with these youth. Such focus~     is critical as suicide is the leading cause of death among homeless youth. Therefore, this~     study seeks to address this gap in the research literature with the goal to identify an~     effective strategy to intervene in suicide ideation in this population.~   "
36686|NCT02576821|"~     Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease~     (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as~     well as the level of hippocampal atrophy in bvFTD may be of similar severity to that~     observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with~     post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can~     also cause impairment of episodic memory mimicking AD, without subcortical cognitive~     profile. Because these diseases involve distinct pathophysiological processes, they require~     different specific care and treatment. In consequence, it is very important to improve our~     knowledge about HS in order to identify its mechanism and improve the diagnosis.~   "
36687|NCT02576808|"~     Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients~     compared with Loratadine.The double blind randomized controlled trial study was approved by~     the Human Research Ethics Committee of Thammasat University NO.1.~   "
36688|NCT02576795|"~     This study is being conducted by Biomarin Pharmaceutical Inc. as an open label, dose~     escalation study in order to determine the safety and efficacy of BMN 270 (an~     Adenovirus-Associated Virus based gene therapy vector in participants with severe~     Haemophilia A.~   "
36689|NCT02576782|"~     In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8~     hours. Increasing the duration of local anaesthetic action is often desirable because it~     prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong~     regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing~     vascular absorption of the local anaesthetic. Additives like opioids, clonidine and~     verapamil were added to local anaesthetics, but the results are either inconclusive or~     associated with side effects. Steroids when used intrathecally are reported to cause~     arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in~     low concentration in peripheral nerve blocks.~      Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural~     injection of steroids is reported to influence postoperative analgesia. They relieve pain by~     reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing~     ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5%~     levobupivacaine in interscalene brachial plexus block showed improvement of postoperative~     analgesia for arthroscopic shoulder operation without any specific complications.~      The objective of this study is to compare the effects of combining of dexamethasone and~     bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients~     undergoing lower limb vascular surgeries. The effects will be studied in terms of:~        -  Onset of sensory blockade and motor blockade~        -  Duration of analgesia / first request for analgesic~        -  Duration of motor blockade~   "
36690|NCT02576769|"~     Basal cell carcinoma (BCC) is the most frequent neoplasia worldwide. There are more than 30~     histopathologic subtypes, however the nodular subtype is the most common. Pigmented~     varieties are common in darker skin types, therefore in our country. Previous studies have~     shown an increase number and size of melanocytes. Melanogenesis were increased at the~     expense of hyperfunctioning melanocytes as well. The aim of the study was to describe the~     characteristics of melanocytes in pigmented and non-pigmented variants of basal cell~     carcinoma.~   "
36691|NCT02576756|"~     The investigator wants to investigate if there is an increased risk of postoperative~     pulmonary problems in patients who have had an intubation where there was need for more than~     a laryngoscope.~   "
36692|NCT02576743|"~     This study aims at investigating the blood hemodynamics with high spatiotemporal resolution~     in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as~     peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D~     flow MRI data acquired at ultra-high field strength (7 Tesla).~   "
36693|NCT02576730|"~     To include patient after traumatic (calcaneal) fractures for this study. They can be~     included to analyze gait with the OFM foot model, a non invasis model. Patient will be~     invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided~     tape on anatomical points. After that gait will be recorded with infra-red camera's and an~     animation model will be formed. With this model further analysis can be made to range of~     motion between different segement of the foot. These results will be compared with patient~     with an arthrodesis, healthy subjects, futher questionnaires, physical examination and~     radiographic findings will be correlated.~   "
36694|NCT02576717|"~     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with~     relapsing multiple sclerosis.~   "
36695|NCT02576704|"~     Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events~     for patients with known or suspected coronary artery disease. If the test is normal, or if~     the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the~     patient is considered at low risk and should be managed with optimal medical treatment only.~      Recently, new gamma cameras using semi-conductor detectors have been developed. Their~     diagnostic performances have been demonstrated and confronted with various anatomical and~     functional reference techniques, such as coronary angiography and FFR. The prognostic value~     of a normal SPECT MPI has not been specifically assessed yet.~      Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of~     coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion~     heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on~     conventional MP-SPECT, but its additive and independent prognostic value over the presence~     of myocardial ischemia remain unknown.~      Accordingly, the purpose of this study is :~        -  To assess the prognostic value of a normal myocardial perfusion stress imaging using a~          semiconductor gamma camera with a dual isotope high speed protocol,~        -  To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a~          new automatized image processing method, in normal SPECT MPIs.~      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive~     of cardiovascular events in patients referred to the Nuclear Cardiology Department for~     routine evaluation of known or suspected CAD.~   "
36697|NCT02576678|"~     This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque~     psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK~     of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of~     apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area~     Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global~     Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a~     total of 107 weeks which includes screening, treatment (including the PK portion of the~     study and the extension treatment period), two short-term follow-up periods and a long-term~     follow-up period.~   "
36698|NCT02576665|"~     This is a multicenter, open label, single arm study of Toca 511 and Toca FC. Based on their~     cancer diagnosis (brain metastases from non small cell lung cancer or breast cancer;~     colorectal cancer with liver metastases; metastatic renal cell carcinoma; locally advanced~     or recurrent melanoma; locally advanced or metastatic pancreatic cancer or breast cancer~     [ie, other than resectable brain metastases]) subjects will receive Toca 511 either~     intravenously (IV) or intralesionally (IL). Up to 6 subjects will be enrolled for each~     disease group. In all but the melanoma group, Toca 511 will be administered by IV injection~     for 3 consecutive days (14 mL per day); in the melanoma group, at least 3 subjects may~     receive Toca 511 by IV injection (same dosing regimen as the other 3 groups), and at least 3~     subjects will receive Toca 511 by IL injection (approximately 0.1 mL to 4 mL for 5~     consecutive days). Based on the disease group, subjects will have either multiple core~     biopsies or a resection of a metastatic lesion (primary for subjects with renal cell~     carcinoma undergoing debulking nephrectomy), approximately 14 to 28 days after Toca 511~     administration. A portion of the resected or biopsied tumor sample will be evaluated for the~     presence of Toca 511 vector sequences and markers for disease characteristics. After~     recovery from the biopsy or surgery (approximately 4-6 weeks from Toca 511 treatment start),~     subjects will begin the first cycle of oral Toca FC (ie, a 7 day course of 220 mg/kg/day;~     thereafter, cycles of 7-day courses of Toca FC will be repeated approximately every 6~     weeks). Toca FC may be continued alone or in conjunction with standard therapy (other~     investigational treatments prohibited). One or more disease groups may be expanded to allow~     replacement of subjects or to provide a better assessment of efficacy. Subjects will be~     followed for safety for up to 15 years as required by regulatory authorities. In addition,~     subjects will be followed for efficacy (objective response and survival).~   "
36699|NCT02576652|"~     Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total~     Hip Replacement~   "
36700|NCT02576639|"~     The study will determine the safety of CNP520 in healthy elderly over 3 months. Data~     relevant for Pharmacokinetic/Pharmacodynamic modeling will be obtained in order to define~     the target dose in subsequent efficacy studies.~   "
36701|NCT02576626|"~     Rationale:~      Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered~     by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and~     wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is~     cumbersome, and, importantly, has never been scientifically been proven to be more~     efficacious than delivery by the other two methods. Yet many patients are happy with wet~     nebulization and in many clinics this administration method prevails. The investigators~     believe that combined long-acting bronchodilators, are more efficacious than combined short~     acting bronchodilators per nebulizers.~      Objective:~      To test the hypothesis that: The combination of the two long-acting bronchodilators~     indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement~     compared to nebulisation with ipratropium/salbutamol, when administered as single dose in~     patients with stable state chronic obstructive pulmonary disease (COPD).~      Study design: Investigator initiated, randomised, active controlled, cross-over double-blind~     (and therefore double-dummy), study comparing the effects of single dose~     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol~     nebulisation in patients with COPD in stable state Study population: Patients visiting the~     outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and~     (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred.~     Intervention The investigators will compare the effects of single dose~     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol~     nebulisation in patients with COPD in stable state~      Main study parameters/endpoints:~      Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium,~     compared to nebulisation with ipratropium/salbutamol~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      This study has no specific benefits for the participating patients. The study also has no~     major risks. Minor risks for participants after a single dosis can be throat irritation,~     cough, headache and dizziness, sinus tachycardia. The combination of treatments with~     β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily~     practice for many years in many countries and they are often prescribed both in COPD. Both~     indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the~     Netherlands~   "
36702|NCT02576613|"~     A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical~     trial will serve to generate preliminary data on the efficacy and safety of modified~     psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes~     of schizophrenia or schizoaffective disorder.~   "
36703|NCT02576600|"~     The aim of this prospective randomized study was to evaluate the impact of peroperative~     pupillometry monitoring on per and post-operative opioid consumption in major gynecological~     surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the~     intervention group, peroperative remifentanil target was guided by pupillometry. In the~     other group, remifentanil was administered according to standard practice.~   "
36704|NCT02576587|"~     The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study.~      The study involves a case control design to investigate the extent to which there is an~     independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial~     fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and~     controls as those without AF. In order to rigorously address important biologic confounding~     influences, the cases and controls will be individually matched based upon age, gender,~     race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index,~     AHI>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the~     Clinical Research Unit (CRU) for collection of the same measures collected at the baseline~     exam to observe for any significant changes with the purpose of collecting effect size data~     to inform future clinical trials.~      The total duration of the study is 4 years. The duration for any individual participant is~     up to from one to 13 weeks months, including a 3-month treatment period for those with~     moderate to severe SDB, i.e. AHI>15.~   "
36705|NCT02576574|"~     The purpose of this study is to demonstrate superiority with regard to progression free~     survival (PFS) based on an Independent Review Committee (IRC) assessment of avelumab versus~     platinum-based doublet in non-small cell lung cancer (NSCLC) subjects with Programmed death~     ligand 1+ (PD-L1+) tumors.~   "
36706|NCT02576561|"~     The purpose of this research study is to test the safety and effectiveness of the~     investigational study vaccine, called TVGV-1. The study will test the vaccine in women with~     high grade HPV cervical infection.~   "
36707|NCT02576548|"~     This research study is designed to evaluate an experimental drug, MEDI4276, in treating~     breast and stomach (gastric) cancer.~   "
36723|NCT02576340|"~     Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase~     the tolerability and compliance of the patient, sedation is applied. There are many studies~     showing that sedation increases the patient compliance and the tolerability. However,~     spasmolytic use in GE has not been evaluated yet.~   "
36724|NCT02576327|"~     The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to~     standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.~   "
36708|NCT02576535|"~     Stereotactic radiosurgery is a well established treatment option for arteriovenous~     malformations (AVMs). The potential complications related to radiosurgery are well~     documented and are predominately related to radiation effects to the surrounding brain~     parenchyma. These risks increase with larger lesions, requiring a concommitant reduction in~     the amount of radiation that can be delivered. This reduction in radiation dose decreases~     the efficacy of treatment. The broad, long-term objectives of this proposal are 1) to~     determine the role of fractionated stereotactic radiosurgery in the treatment of large~     (>10cc) AVMs; 2) to evaluate the complication rates related to fractionating these doses~     compared to conventional stereotactic treatment 3) to evaluate the success rate of treating~     large AVMs with this protocol.~   "
36709|NCT02576522|"~     Investigators designed a study of a multimodality approach: surgery followed by~     hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for~     patients with single, large brain metastases from solid primary tumor~   "
36710|NCT02576509|"~     The purpose of this study is to determine if nivolumab or sorafenib is more effective in the~     treatment of Advanced Hepatocellular Carcinoma.~   "
36711|NCT02576496|"~     This study evaluates the efficacy, safety and pharmacokinetics of EDO-S101 in patients with~     relapsed/refractory hematologic malignancies. All patients will receive EDO-S101.~   "
36712|NCT02576483|"~     The principle investigator is evaluating self-reported quality of vision and quality of life~     in physicians undergoing LASIK and PRK surgery.~   "
36713|NCT02576470|"~     The overall goal is to exploit motor learning principles and adjuvant techniques in a novel~     way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of~     three forms of biofeedback on training and determine whether adjuvant therapeutic techniques~     such as non-invasive neural stimulation and reward augment training outcomes has an effect~     of dysphagia rehabilitation. Outcomes from this research study may change the paradigm for~     treating swallowing and other internal functions such as speech and voice disorders.~   "
36714|NCT02576457|"~     The purpose of this study is to determine whether BMS-936559 is safe and has the desired~     pharmacologic activity in patients who have severe sepsis.~   "
36715|NCT02576444|"~     The primary objective of this phase II trial is to determine tumor overall response rate~     (ORR) in molecularly selected patients with measurable disease as assessed by the Response~     Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment~     across tumor types in each arm of the study.~   "
36716|NCT02576431|"~     Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a~     fusion of NTRK1, NTRK2 or NTRK3.~   "
36717|NCT02576418|"~     To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and~     negative predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14~     days from testing and to compare it with cervical length (CL) measurement by transvaginal~     ultrasound (15 mm cut-off)~   "
36718|NCT02576405|"~     It has been established that patients with psychiatric disorders tend to do worse in a~     surgical setting. Some types of surgery with greater impact than others, including~     orthopedic surgery. In our research group the investigators have shown this to be the case~     for hip and knee replacements within the mentioned patient category. However, the role of~     psychiatric disorder and use of different psychopharmacological drugs in relation to~     perioperative morbidity and mortality have not been thoroughly examined. The objective of~     this study is to shed light on the issue.~      Recent studies have shown that different types of psychiatric disorder influence surgical~     outcome differently. This emphasizes the need for specific knowledge regarding psychiatric~     diagnoses preoperatively. In this study around 2000 patients with or without psychiatric~     disorder of any kind will be studied preoperatively, which according to our previous study~     will include more than 200 patients receiving psychopharmacological treatment. The specifics~     that characterize every patient's psychiatric trades will be included in a validated~     questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been~     chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen.~     Preoperative information regarding their mental condition and medicine will be linked to~     surgical outcome in order to identify potential hazards in the perioperative period.~   "
36719|NCT02576392|"~     This randomized trial evaluates an intervention to minimize use of opioids following total~     hip and total knee replacement. Half the participants will receive an intervention (mailed~     educational materials, followed by a pharmacist call), and half will receive usual care.~   "
36720|NCT02576379|"~     Stroke is a leading cause of death and disability, and 15 million people suffer a stroke~     each year; one-third die and one-third are left permanently disabled. Because the risk of~     stroke increases with age, it has been considered a disease of the elderly, but stroke also~     occurs in middle-aged people.~      Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion~     therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to~     thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of~     serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction~     of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be~     system delays including prolonged transportation.~      In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was~     implemented in the Eastern part of Denmark. An observational study evaluating the short-term~     effects of HEMS implementation compared patients transported by conventional ground~     ambulance (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS.~     Patients transported by helicopter had increased time to specialized care. However, both~     30-day and 1-year mortality was slightly lower in patients transported by HEMS, although not~     significant, as was the degree of disability at three months measured by the modified Rankin~     Scale (mRS).~   "
36721|NCT02576366|"~     Single center, open label crossover study with 2 treatment phases in healthy volunteers.~      The potential of phenotypic drug probes to predict drug-drug interactions between~     tacrolimus, voriconazole and rifampin will be assessed.~   "
36722|NCT02576353|"~     The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic~     relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The~     secondary objective is to determine the safety and tolerability of fentanyl sublingual spray~     in opioid naive subjects.~   "
36726|NCT02576301|"~     Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in~     combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or~     MDS.~      Phase 2 will investigate overall response rate of OXi4503 in combination with~     intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior~     hypomethylating agent (Arm A) and 2) subjects with relapsed and refractory AML after~     treatment failure of up to 1 prior chemotherapy regimen (Arm B).~   "
36727|NCT02576288|"~     Abdominal obesity is a major risk factor for heart attack, stroke, peripheral vascular~     disease, dementia, cancer and Type 2 diabetes. The central hypothesis for this proposal is~     that pro-atherogenic mediators emanate from inflammation in deep subcutaneous adipose tissue~     (dSAT) that are released into the systemic circulation and damage the arterial vasculature.~     The investigators postulate that inflammation of dSAT, when quantified by macrophage~     phenotyping/enumeration will be a) closely linked with systemic levels of pro-atherogenic~     mediators and b) tightly associated with endothelial dysfunction and loss of central~     arterial elasticity, which are highly predictive of future cardiovascular disease (CVD)~     complications. These relationships provide the basis for macrophage-targeted therapy to~     reduce obesity-related inflammation and impaired arterial vasoreactivity. The investigators~     will evaluate a novel approach using a dipeptidyl peptidase 4 inhibitor (DPP4i) sitagliptin,~     which blocks signal transduction for monocyte/macrophage activation. Thus, in abdominally~     obese, 18-40 years-old adults without clinical CVD, the show study is expected to show that~     sitagliptin versus placebo will:~        1. significantly improve early measures of arterial damage (brachial artery endothelial~          dysfunction and reduced carotid elasticity).~        2. significantly attenuate inflammation in dSAT and local production of pro-inflammatory~          mediators in adipose tissue, which will be associated with decreases in systemic~          pro-atherogenic mediators that contribute to atherogenesis.~      Since many obese persons fail to sustain weight loss by lifestyle interventions including~     diet and exercise, an important public health goal is to identify relatively safe~     alternative strategies that can be used pre-emptively in asymptomatic obese persons when~     arterial dysfunction and damage is still reversible before atherosclerosis progresses to~     serious CVD events.~   "
36728|NCT02576275|"~     This study will evaluate the efficacy and safety of duvelisib in combination with~     bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab~     (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).~   "
36729|NCT02576262|"~     Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human~     papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence.~     the investigators evaluated the potential role of HPV Integration detection in cervical~     exfoliated cells in HPV-positive women from a clinic-based population.~   "
36730|NCT02576249|"~     Corticosteroid injections are commonly used for the symptomatic treatment of knee~     osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid~     and local anesthetic, with the rationale of providing longer duration pain relief with the~     corticosteroid and immediate, though short duration relief with the anesthetic. However,~     multiple in vitro and animal studies have shown that local anesthetic may be harmful to~     chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many~     clinicians believe incorporating the anesthetic is important because it can provide~     immediate pain relief and facilitate patient confidence in the treatment program. However,~     there is no published data to validate this reasoning. Therefore, the anesthetic has unknown~     clinical benefit and may have adverse effects on articular cartilage. In light of this, the~     investigators question the routine use of anesthetics in joint injections. The purpose of~     this study is to compare the effects of knee joint injections using: 1) corticosteroid with~     local anesthetic versus 2) corticosteroid with normal saline.~   "
36731|NCT02576236|"~     The H pylori infection remains a public health problem. The eradication rate with the first~     line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due~     to the frequency of resistance to clarithromycin, which reaches 21% in France. Until~     now,European and French consensus recomended tofavor sequential therapy (5 days~     PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy (~     10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence~     of clarithromycin resistance reported eradication rate of 85% with sequential therapy and~     reported a low impact of clarithromycin resistance on the effectiveness of this treatment.~     However, recent studies suggest a greater impact of clarithromycin resistance. Recent~     meta-analysis shows that empiric sequential therapy is less efficacious than concomitant~     quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015)~     recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first~     line in order to reach an eradication rate >90%.~      In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared~     a triple therapy guided by the results of a PCR test that detects resistance to~     clarithromycin and levofloxacin (HelicoDR ®) to empirical triple therapy~     (PPI-amoxicillin-clarithromycin). 1384 patients and among them 526 infected patients were~     enrolled in 10 centers. The results in 415 patients were 73.1% for the empirical treatment~     versus 85.5% (p <0.001) for the treatment guided by PCR HelicoDR®. This study also~     demonstrated the limits of the test HelicoDR®: onerous, possibility of contamination, little~     practical contribution of the determination of resistance to quinolones.~      Moreover, it has been shown that triple therapy efficiency could be optimized by increasing~     duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90%~     were reported with susceptible to clarithromycin strains.~      Adverse events are less common with optimized triple therapy than with concomitant quadruple~     therapy.~      The main objective is to compare the efficacy of optimized triple therapy guided by the~     results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant~     therapy (eradication rate 90% hypothesized).~      The secondary objective is to determine side effects of optimized guided triple therapy as~     well as the quadruple concomitant therapy in France.~   "
36732|NCT02576223|"~     The purpose of this randomized study is to examine the effect of a selective suprascapular~     nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects~     will receive a active nerve block with Ropivacain. Half of the subjects will receive a~     placebo nerve block with saline.~   "
36733|NCT02576197|"~     This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional~     treatment of mild to moderate plaque psoriasis. Half of the patients will receive the~     probiotic per os, while the other half will receive a placebo; all patients will continue~     with their regular psoriasis treatment.~   "
36734|NCT02576184|"~     This study aim to assess long-term results of an incisional hernia-prophylactic mesh~     placement during stoma reversal after total mesorectal excision (TME) for rectal cancer~   "
36735|NCT02576171|"~     The primary objectives of this study is to test the feasibility and efficacy of~     group-therapy supported internet-delivered CBT for adolescents (13 - 17 years) with social~     anxiety disorder. Investigators will conduct an open trial with N = 30 participants.~     Participants will be assessed at baseline, immediately after treatment and at a 6-month~     follow-up.~   "
36736|NCT02576158|"~     The primary objective is to determine the sensitivity and specificity of the HPV~     Integration-based cervical screening for detection of high-grade cervical intraepithelial~     neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be~     confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.~   "
36737|NCT02576145|"~     This study will assess whether daclizumab impairs the ability of children receiving a kidney~     transplant to elicit a primary immune response. The anticipated time on study treatment is 1~     day, and the target sample size is 82 individuals.~   "
41229|NCT02517346|"~     The purpose of this study is to compare the effectiveness of telemonitoring versus standard~     follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).~   "
36738|NCT02576132|"~     This study was part of a quality improvement project at the Department of Anesthesiology and~     Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.~      Being in pain is reported to be one of the most important stressors in critically ill~     patients and worsens outcome. The evaluation of pain using validated scores in patients who~     are able to self-report significantly improves the quality of analgesic therapy and health~     related outcomes in intensive care patients.~      However, behavioral pain score that are used in sedated or delirious patients, often~     underestimate the severity of pain.~      The primary aim of this study is to investigate if measurement of the pupillary light reflex~     Amplitude correlates with the results of pain assessment using validated pain scores in~     critically ill patients.~   "
36739|NCT02576119|"~     The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the~     QT interval corrected with Fridericia's method (QTcF) in healthy subjects.~   "
36740|NCT02576106|"~     The primary objective of this monocentric and feasibility study is to review the efficacy of~     cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients,~     with lumpectomy indication.~      The efficacy is defined by the rate of success of cryotherapy procedures. For each one of~     those evaluated process, an success will be defined on the tumor sample of lumpectomy by the~     absence of viable tumour cells.~      On the basis of our expertise, it seems interesting to propose this experimental procedure~     to patients as described above.~   "
36741|NCT02576093|"~     Purpose of the study is the local tolerability and systemic safety of a novel k-opioid~     receptor agonist proven to inhibit inflammation and pruritus in preclinical model of~     dermatitis.~      Three concentrations of WOL071-007 and placebo will be applied to patients with AD in a~     first-in-human, single-center, combined single/multiple ascending dose (SAD/MAD),~     double-blind, placebo-controlled, half-side comparison (MAD part only) study. The IMP will~     be applied occlusively to lesional or non-lesional skin. In the SAD part 24 subjects will~     receive the IMP for 2 days. In the MAD part, 30 hospitalized subjects will receive the IMP~     for 6 days. Study objectives are the safety and tolerability as well as (MAD part only) the~     pharmacokinetics and efficacy of WOL071-007.~   "
36742|NCT02576080|"~     Following the ACOSOG Z9001trial, imatinib received market authorization in Europe for~     patients with GIST at significant risk of relapse in the adjuvant setting, according to the~     classifications of Miettinen and Joensuu. Thereafter, the SSG XVIII / AI trial proved the~     need to revise the recommendations of the European Society for Medical Oncology regarding~     the optimal duration of treatment, which is currently three years. Patients at low risk of~     recurrence should not receive adjuvant treatment with imatinib and recommendations cannot be~     made from the literature data as to the indication of adjuvant treatment for patients with~     an intermediate risk of relapse. The provision of prognostic molecular markers in this group~     of so-called intermediate-risk subjects would facilitate the identification of responders to~     imatinib and avoid overtreating some patients and undertreating others who would benefit~     from Imatinib. Recently, Lagarde et al. have shown that the Genomic Index (GI = A ² / C,~     where A is the total number of alterations gains or losses and C is the number of~     chromosomes involved in these alterations in Comparative Genomic Hybridization array(CGH~     array)) could have prognostic value in GIST, particularly in intermediate risk GISTs. More~     recent work by the same author in 100 cases of GISTs with intermediate prognosis according~     to the classification of Miettinem identified two prognostic groups based on GI. The rate of~     metastatic relapse at 2 years was 30.6% in the group with GI greater than 10 versus 5.4% in~     the group with GI less than 10 (manuscript under preparation). Thus, it is legitimate to set~     up a randomized trial to study the effectiveness of adjuvant treatment with imatinib in the~     GIST population at intermediate risk of relapse and with a high GI. This study is a~     prospective randomized clinical trial: a phase III, open-label, 2 parallel groups,~     multicenter study. The primary objective of this study is to assess the efficacy of adjuvant~     Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk~     gastrointestinal stromal tumor presenting a high Genomic Grade Index. The second objectives~     of this study are to compare the two therapeutic approaches in terms of metastasis-free~     survival at 1 year, 2 years and 3 years, overall survival, clinical and biological~     tolerance, safety and Quality of life of patients and caregivers. The eligible subjects must~     meet all of the following criteria : subject with a gastrointestinal stromal tumor,~     intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen~     2006], subject with Genomic Grade Index higher than 10 determined by CGH array, subject with~     surgery for primary tumor performed from 2 weeks to 2 months before starting adjuvant~     Imatinib mesylate, subject with no evidence of residual macroscopic disease after surgery~     and with a medical decision to prescribe imatinib. Subjects meeting any of the following~     criteria must not be enrolled : subject who have experienced spontaneous tumor rupture~     before surgery, subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from~     tumor Block and subject whose mutational status meets the wild phenotype definition as~     evidenced by sequencing from tumor Block.~      The Standard Group will receive adjuvant imatinib at a dose of 400 mg per day for a period~     of 3 years. Patients will be assessed for metastases every three months for three years with~     thoraco-abdominal and pelvic CT scan. The Experimental Group will receive the same~     thoraco-abdominal and pelvic CT scan. The estimated proportion of subjects relapsing at 2~     years will be 30% in the experimental group and 2.5% in the standard group: alpha risk, 5%,~     power 80%. A total of 80 subjects (40 in each arm) will be included. This is a trial~     combining two learned societies that already are taking part in many clinical trials in~     France (French Sarcoma Group and French Digestive Cancer Federation). The expected benefits~     for patients are : not treat subjects for whom this treatment would offer too little benefit~     weighed against the disadvantages and treat subjects in whom this treatment would provide a~     real benefit and reduce the cost of treatment in patients who would not benefit from being~     treated by imatinib. The originality of this study is that it will include molecular data in~     the therapeutic decision and demonstrate the concept of individualized treatment in this~     patient population. This could ultimately change the current recommendations.~   "
36743|NCT02576067|"~     Vascular inflammation, a central feature of atherosclerosis, participates in the initiation,~     perpetuation and instability of plaques. Multiple clinical trials of cholesterol lowering~     therapy with statins have demonstrated that reductions in atherosclerotic cardiovascular~     disease (CVD) events are associated with reductions in both LDL cholesterol (LDL-C) and the~     systemic inflammatory mediator C-reactive protein (CRP). The Cardiovascular Inflammation~     Reduction Trial (CIRT) investigates if an anti-inflammatory agent commonly used in~     rheumatoid arthritis (low dose methotrexate (LDM)) can reduce CV morbidity and mortality~     among patients with a prior myocardial infarction or angiographically demonstrated~     multivessel coronary artery disease (GCO#13-1467).~      In this ancillary CIRT imaging study, the investigators propose to use this well validated~     approach by non-invasive serial FDG-PET/CT imaging in a subset of patients enrolled in the~     main CIRT trial to directly visualize vascular inflammation. Once the subjects are enrolled~     in the main CIRT trial, baseline imaging will be done and follow up imaging will be done~     approximately 8 months after the baseline imaging.~      18FDG-PET imaging data will be acquired, analyzed centrally and results incorporated into~     the main CIRT database. The investigators hypothesize that LDM treatment will result in a~     significant decrease in plaque inflammation as measured by 18-FDG-PET/CT after 8 months as~     compared to placebo.~   "
36744|NCT02576054|"~     This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1~     Virus-Like Particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two~     periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up~     to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety~     from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted~     when all subjects have completed their Month 7 visit or have been discontinued before that~     time. The second analysis will be conducted at the end of study. The primary hypothesis~     tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at~     4 weeks postdose 3.~   "
36745|NCT02576041|"~     The aim of the study is to evaluate the effects of Bilastine on patients' attention and~     reactivity levels by measuring psychophysical performance at a F1-high speed simulator~     driving test.~   "
36746|NCT02576028|"~     Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show~     important differences between types and numbers of treatment sessions. Objectives are to~     investigate effectiveness of Fascial Manipulation when associated to a standard protocol of~     care.~   "
36747|NCT02576015|"~     The interaction of analgesia and sedation ot their effect on the prognosis of surgical~     patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia~     and sedation to improve the prognosis of surgical patients is still a~     mystery.Intra-operative nerve block provided regional analgesia of the operated knee, which~     reduced the dosages of sedatives and analgesics.Based on a pilot study,the investigators~     found a decrease of post-operative adverse composite outcomes with the use of continuous~     femoral nerve block (2% versus 7%) ,therefore, the investigators postulate that general~     analgesia with lighter sedation in combination with peripheral nerve block could reduce the~     post-operative morbidity compared with deeper sedation.This randomized controlled trial is~     designed to test this hypothesis in patients receiving unilateral knee arthroplasty.~   "
36748|NCT02576002|"~     To describe the prevalence, incidence and current treatment and procedures patterns in a US~     pediatric population with PAH in MarketScan database during the period 2010-2013~   "
36749|NCT02575989|"~     The purpose of this study is to demonstrate that the specific management will increase the~     number of alive trauma patient arriving with a temperature > 35°C.~   "
36750|NCT02575976|"~     The purpose of this trial are to pragmatically investigate whether participation in a~     comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in~     better functional capacity, cardiovascular risk factor control, health behavior,~     disease-related knowledge, depressive symptoms and lower mortality when compared exercise~     only CR or wait list control.~   "
36808|NCT02575222|"~     This study will evaluate the use of nivolumab before surgery in patients with high-risk~     clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody~     that may help activate the immune system by blocking the function of an inhibitory molecule,~     PD-1.~   "
36751|NCT02575963|"~     The study is a multicenter, open label Phase I/II trial.~      The goal of the Phase I part of this study is to find the highest tolerable dose of~     Lintuzumab-Ac225 that can be given with cytarabine to patients with AML.~      The goal of the Phase II part of this study is to learn if Lintuzumab-Ac225 and cytarabine~     can control AML. The safety of this drug combination will also be studied.~      Lintuzumab-Ac225 is designed to deliver radiation therapy directly inside leukemia cells~     without giving any radiation to the surrounding normal cells~      Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop~     the DNA from repairing itself.~   "
36752|NCT02575950|"~     An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,~     double-blinded, split-pace (left/right) design trial to evaluate the efficacy and~     tolerability of LEO 43204 in adults with moderate to severe acne.~   "
36753|NCT02575937|"~     The purpose of this study is to investigate the efficiency of nutrition education-based low~     glycemic diet intervention on community diabetic patients.~      Design: Randomized clinical trial.~      Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）~   "
36754|NCT02575924|"~     In this study the suitability of two -sequential and single step- commercially available~     culture media from the same brand was compared. The aim of such study is to verify whether~     is possible to improve the efficiency of infertility treatments in those couples who usually~     have a high cycle cancellation rate, such as poor responder patients and severe male~     infertility. The study population is composed of couples attending the fertility clinic: to~     this purpose all those couples approaching IVF treatments with a diagnosis of OAT,~     cryptozoospermia, advanced maternal age and women with a poor responder diagnosis were~     recruited. IVF treatments were randomly set to be cultured either with two-step sequential~     media or with one-step media to acquire data concerning the ongoing embryo culture~     development and clinical outcomes.~   "
36755|NCT02575911|"~     The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ~     keratomileusis (LASIK) flaps created with the LenSx® Laser.~   "
36756|NCT02575898|"~     To assess the feasibility of a creative writing intervention in an advanced cancer~     population. Given it is a relatively simple intervention delivered by a non-clinician, the~     investigators are interested in better understanding its pattern of effect on patient~     psychological adjustment. The investigators aim to assess its feasibility in this study in~     order to inform a future larger study that will utilize a control arm.~   "
36757|NCT02575885|"~     This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco~     electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various~     types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from~     conventional cigarettes (the participant's own brand) may help provide information about the~     use of nicotine-containing products that may help inform/reform current tobacco policy,~     practice, and harm reduction approaches.~   "
36758|NCT02575872|"~     This randomized clinical trial studies a physical activity behavioral intervention in obese~     endometrial cancer survivors. Learning about physical activity behavior while participating~     in a fitness class may help increase physical activity and improve the quality of life of~     obese endometrial cancer survivors.~   "
36759|NCT02575859|"~     The prognosis of peritoneal metastases from colorectal cancer has recently improved with~     cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although~     outcomes are further improved when early stage peritoneal metastases are treated, adjuvant~     HIPEC has not yet been thoroughly addressed. This prospective pilot study assessed~     feasibility, safety and efficacy of HIPEC performed simultaneously with primary curative~     surgery in colorectal cancer patients with primary tumor-related risk-factors for the~     development of metachronous peritoneal metastases.~   "
36760|NCT02575846|"~     The purpose of this study is to determine which type of food results in a shorter hospital~     stay and better overall outcome for babies born with gastroschisis.~   "
36761|NCT02575833|"~     A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in subjects with~     stable angina to evaluate the effect of AMG 334 compared to placebo on exercise time during~     an exercise treadmill test (ETT)~   "
36762|NCT02575820|"~     The investigators sought to examine the effects of 'old' red blood cells on mortality and~     morbidity of patients who undergoing revision hip replacement arthroplasty. The~     investigators hypothesis is that patients have an increased risk of mortality and infection~     after 'old' red blood cells transfusions compared with those who received 'new'~     transfusions.~   "
36763|NCT02575807|"~     This 2-part, phase 1/2 trial examines the side effects of cancer immunotherapy with CRS-207~     alone and in combination with epacadostat (INCB024360), an indoleamine 2,3-dioxygenase~     (IDO1) inhibitor, and to see how well they work in treating patients with ovarian, fallopian~     tube, or peritoneal cancer who progressed on a platinum-based chemotherapy within 6 months.~     CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically~     modified to reduce its ability to cause disease, while maintaining its ability to stimulate~     potent immune response to kill tumor cells. Epacadostat is a potent, highly selective IDO1~     inhibitor which stimulates immune cell activation in tumors.~   "
36764|NCT02575794|"~     This phase I trial studies the side effects and best dose of terameprocol in treating~     patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as~     terameprocol, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading.~   "
36765|NCT02575781|"~     Primary Objectives:~      To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single~     agent in patients with advanced solid tumors.~      To evaluate the anti-tumor response of SAR428926 when administered as a single agent in~     patients with advanced triple negative breast cancer (TNBC) positive for the protein~     targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when~     administered as a single agent in patients with advanced solid tumors positive for the~     protein targeted by SAR428926~      Secondary Objectives:~      To determine the overall safety profile of SAR428926 as a single agent. To characterize the~     pharmacokinetics (PK) profile of SAR428926 and its metabolites.~      To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate~     the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response~     in all treated patients.~      To evaluate the benefit of primary prophylaxis on the occurrence of corneal~     (keratopathy/keratitis) toxicity (Expansion cohorts).~   "
36766|NCT02575768|"~     Exertional angina is common symptom in patients with severe aortic stenosis (AS) without~     obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one~     of the proposed explanations for angina, little is known about the pathophysiology.~      This study aimed that adenosine-stress cardiac magnetic resonance can be used for the~     assessment of myocardial perfusion reserve and suggest the pathophysiology of development of~     angina in patients with severe AS without obstructive CAD.~   "
36767|NCT02575755|"~     Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low~     birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult~     to implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be~     practical and effective. In PNG, pregnant women currently receive IPTp using~     sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by~     parasite resistance.~      The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and~     efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New~     Guinea women. The study will comprise of two sub-studies:~      (i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety,~     tolerability and preliminary efficacy study of AZI-PQ in pregnancy.~   "
36768|NCT02575742|"~     The reason chronic constipation (CC) becomes commoner with age is not fully understood. New~     studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are~     important and may differ in older people. Since CC reduces quality of life and is a major~     reason why elderly are admitted to hospitals and residential care, there is a need to~     understand how these factors change with age.~      Currently, placing a pressure sensing catheter inside the large intestine (pancolonic~     manometry) is the gold standard way to measure how well it contracts. However this involves~     a camera test (colonoscopy) which is invasive with risks of bowel perforations~     (~80/100,000). The risk is higher with age (64-80yr: ~90/100,000; 80+yrs: ~120/100,000),~     making it unethical for elderly.~      A technique called the 3D-Transit System has been developed, involving a small ingestible~     capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule~     swallowed by participants, it provides precise detailed information on the capsule~     progression inside the whole gut and large bowel's contractile activity in real-time. It is~     minimally-invasive and radiation-free, making it possible to assess elderly for the first~     time.~      This study aims to assess how bowel contraction patterns, dietary fibre intake and gut~     bacteria differ between young and older adults (with and without CC), to better understand~     why CC is more common in elderly.~      It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years~     and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3~     weeks, containing 2 weeks of run-in period and 1 week of study period.~      The four groups participants will be asked to: swallow 2 capsules to assess their large~     bowel's contractile function using the 3D-transit system; provide stool samples to analyses~     their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.~   "
36769|NCT02575729|"~     Purpose: To compare the outcome between sonography-guided steroid injection and direct~     steroid injection on carpal tunnel syndrome(CTS).~   "
36770|NCT02575716|"~     The objective of this study was to evaluate intubating condition using the McGrath® VL~     Series 5, with and without muscle relaxant~   "
36771|NCT02575703|"~     This type of study is called a radiolabeled study. For this study, LY3023414 has been~     specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally~     occurring radioactive form of the element carbon. Adding a low dose of radiation to the~     study drug does not change how the drug works but helps to identify when the drug appears in~     the blood, urine, breath, and stool after it is given. The study will last about 15 days for~     each participant, not including screening. Screening is required within 28 days prior to~     enrollment. This study is for research purposes only and is not intended to treat any~     medical condition.~   "
36772|NCT02575690|"~     Potential protective cardiovascular effect of Spirulina maxima supplementation was studied~     in a double-blind placebo-controlled trial of obese subjects with treated hypertension, each~     randomized to receive spirulina or a placebo.~   "
36773|NCT02575677|"~     Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy~     and effects of oxycodone to the newborn has not been studied. In the present study, patient~     who has received oxycodone is asked about pain relief and after labour single venous blood~     sample from the parturient and umbilical cord are taken for the analysis of oxycodone.~   "
36774|NCT02575664|"~     Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity~     for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1~     -receptors. It acts as a partial agonist at the mu-opioid and as a partial~     agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors.~     Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more~     potent when compared to morphine.~      Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine~     low dose patches are recommended for treatment of moderate pain for example osteoarthritis~     pain. It is known that well treated pain even preoperatively may prevent prolonged~     postsurgical pain.~      In the present study the effects of low dose buprenorphine on postoperative pain and~     recovery were assessed.~   "
36775|NCT02575651|"~     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this~     study will be to investigate the safety and tolerability of Fluzoparib Capsule when given~     orally to Chinese patients with advanced solid malignancies. In addition, the~     pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.~   "
36776|NCT02575638|"~     This is a single-arm, non-randomized feasibility and Phase I trial of 20(S) Camptothecin~     Propionate administered orally. CZ48 will be administered in successive cohorts of 1 patient~     per participating site until hints of toxicity (grade 2 or worse adverse events related to~     the drug) are observed. Then cohorts of 3+3 patients will be treated. CZ48 will be~     administered orally daily (1 course = 4 weeks). No pre-medications will be administered.~     Patients will be asked to drink up to one gallon of fluid daily if possible to flush the~     bladder to mitigate cystitis. Cystitis is an anticipated toxicity as CZ48 is a pro-drug of~     CPT (Camptothecin)~   "
36777|NCT02575625|"~     Hypothesis of this study is the existence of a relation between parameters measured by~     FibroScan® FS 502 according to our non invasive method and liver steatosis condition.~      This proof of concept validation is made up of two steps:~        -  Step 1: feasibility study of the method on 10 healthy volunteers~        -  Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25~          between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et~          whom the histological answer is clean steatosis (NAFLD).~      Experimental procedures consist in:~        -  Fibroscan measure, preceded by tracking ultrasonography.~        -  liver MRI (for substudy about MRI comparison, in step 2)~        -  a blood test for biological assessment of liver functions~   "
36779|NCT02575599|"~     The overall aim of this study is to assess the effectiveness of a web-based Guided~     Self-Determination program among adults with type 2 diabetes in general practice in order to~     improve diabetes self-management behaviours and HbA1c through enhanced patient activation,~     self-care competence, and autonomy.~   "
36780|NCT02575586|"~     The main objective of this study is to analyze the effect of dry needling of the soleus~     muscle to modulate muscle tone in healthy non-injured subjects. The secondary objective is~     to study if effects occur due to changes in the neural or mechanical component (or both).~      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the~     soleus muscle produces changes in muscle tone varying the passive resistance torque at a~     rate of 180º/ s.~   "
36781|NCT02575573|"~     The investigators will retrospectively examine the connection between resuscitation~     decisions of admitted patients at the ED of the University Hospital of Basel and several~     demographic and health related measures. Additionally there will be an examination, which~     patient characterestics may have lead to patients not having been asked about resuscitation~     decisions.~   "
36782|NCT02575560|"~     EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small~     cell lung cancer with EGFR gene mutation. The median progression free survival time is~     around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with~     first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug~     administration maybe prolong patients PFS and evently prolong OS.~   "
36783|NCT02575547|"~     This is an prospective，open-label, none-interventional, observational， multicenter phase II~     clinical trial. The purpose of this study is to observe the effect of neoadjuvant~     chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in~     locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of~     patients' nutrition status during the treatment and the connection between nutrition changes~     and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT~     and provide data and basis for further study。~   "
36784|NCT02575534|"~     The aim of this study is to determine if anti-arrhythmic drugs with a sodium~     channel-blocking mechanism exert a detrimental electromechanical effect on cardiac function~     in patients depending upon baseline intraventricular conduction and left ventricular~     function.~   "
36785|NCT02575521|"~     Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a~     study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial~     hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and~     intra-cranial pressure (ICP) were least with sevoflurane.~      Propofol is the most commonly used intravenous anesthetic. It has many theoretical~     advantages by reducing cerebral blood volume (CBV) and ICP and preserving both~     autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol~     were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or~     sevoflurane.~      The well known pharmacodynamic advantages of intravenous anesthetics may give this group of~     drugs superior cerebral effects when compared with inhalation anesthetics.~   "
36786|NCT02575508|"~     This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth~     factor receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil,~     irinotecan hydrochloride and oxaliplatin (combination chemotherapy) in treating patients~     with untreated pancreatic cancer that has spread to another place in the body. Pan FGFR~     kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan~     hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving pan FGFR kinase inhibitor BGJ398 together with fluorouracil, irinotecan~     hydrochloride and oxaliplatin may be a better treatment for pancreatic cancer.~   "
36787|NCT02575495|"~     The major hypothesis to be tested is that there was no difference in the clinical outcome~     between 7(short-course) and 14(traditional-course) days of antibiotic treatment for~     asymptomatic bacteriuria early after kidney transplantation.~   "
36788|NCT02575482|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     SUVN-D4010 in healthy male subjects following single or multiple ascending doses.~   "
36789|NCT02575469|"~     Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g.~     ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best~     way to measure exercise capacity is to perform a cardiopulmonary exercise testing.~     Normal/reference values in health and disease relate to specific population and~     subpopulations. The population in Israel is unique in its diversity.~      Objectives: Data collection of exercise capacity assessment in health and illness in the~     northern of Israel for future local database.~      Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology~     institute) and healthy volunteers evaluated as controls.~      Study design: Prospective observational study. Participants will answer a health related~     questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a~     treadmill or a cycle ergometer.~   "
36790|NCT02575456|"~     A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and~     Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)~     in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.~   "
36791|NCT02575443|"~     The purpose of this study is to evaluated whether the depth of neuromuscular block may~     affect the unicon value of anesthetic depth monitoring system (ADMS).~   "
36792|NCT02575430|"~     To evaluate the natural history of visual function in subjects with IRD phenotypically~     diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65~     or LRAT gene mutations.~   "
36793|NCT02575417|"~     This study will determine the feasibility of using an end-of-life conversation game (called~     My Gift of Grace) as a community engagement activity series to help caregivers, patients~     with chronic illness, and/or their families perform advance care planning.~   "
36794|NCT02575404|"~     This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of~     pembrolizumab in patients with advanced melanoma.~   "
41248|NCT02517086|"~     The objective of this study is to evaluate the effect of elastic compression, functional~     compressive bandaging (ECF) and active exercises in the bloodstream of the upper member~     ipsilateral to the surgical procedure for the treatment of breast cancer.~   "
36795|NCT02575391|"~     This study will evaluate whether a Whole Food Intervention reduces the frequency or severity~     of esophagitis in patients receiving treatment for non-small cell lung cancer.~      The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3~     portioning cups, equal to approximately 12 ounces, taken daily before starting radiation~     therapy.~   "
36796|NCT02575378|"~     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with~     metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the~     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus~     Chinese Traditional Medicine.~      In this Prospective, open-label, randomised controlled trial, the investigators will recruit~     159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease~     evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and~     be randomised into two group, capecitabine metronomic chemotherapy only as control group and~     the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This~     treatment regimen will be continued until progression, death, or an unacceptable adverse~     event.~      The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall~     survival (OS), quality of life (QOL) and toxic effects.~   "
36797|NCT02575365|"~     This is a 24-month, open-label, multicenter study with a single treatment arm design.~      Primary objective of this study is:~      -To investigate the effects of Fingolimod on cognitive performance in highly active~     relapsing remitting multiple sclerosis patients~      Secondary objectives of this study are:~        -  To investigate the correlation between the effect of fingolimod on cognitive~          performances and MRI data.~        -  To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin~          and matrix metalloproteinases) related to neurodegeneration~        -  To investigate the effect of fingolimod on brain gray matter atrophy and thalamic~          atrophy.~      Polulation We will recruit a minimum of 80 relapsing remitting MS (RRMS) patients according~     to the McDonald criteria.~   "
36798|NCT02575352|"~     CPC REGISTRY is a multi-center, international, prospective, open-label, observational study~     on the use of injectable calcium phosphate cements for the treatment of bone defects in~     adults. All patients will be treated with any of the two injectable calcium phosphate bone~     substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard~     clinical practice and according to the information provided by GRAFTYS manufacturer in~     respective device Instructions For Use (IFU).~   "
36799|NCT02575339|"~     This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard~     sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses.~     Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or~     the sorafenib arm.~   "
36800|NCT02575326|"~     Little guidance is given to physicians caring for obese adolescents with asthma, however,~     findings suggest that interventions designed to achieve asthma control in these patients are~     necessary. Because of the psychosocial factors often associated with obesity and asthma~     (e.g., low self-esteem, depression, and low quality of life) successful interventions should~     incorporate a patient-centered approach. The proposed study design is a clinic-based,~     randomized controlled trial (RCT) in teens with a history of asthma and who are overweight~     or obese.~   "
36801|NCT02575313|"~     This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter,~     honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and~     neck cancer patients undergoing standard treatment.~   "
36802|NCT02575300|"~     This is a prospective phase II open-label trial, stratifying patients equally into two~     cohorts consisting of carcinoid tumors and pancreatic neuroendocrine tumors (pNETs). The~     purpose of this study is to test any good and bad effects of the study drug called~     Ibrutinib.~      The study population will consist of adult patients with histologically confirmed low to~     intermediate grade NETs of the GI tract, lungs and unknown primary (carcinoid tumors) or~     pNETs. All patients must be confirmed to have advanced disease. The study will enroll up to~     51 patients in two cohorts (30 carcinoid and 21 pNET patients).~   "
36803|NCT02575287|"~     White light endoscopy remains the gold standard technique to evaluate gastrointestinal~     tract. Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms~     (heartburn and regurgitation) associated or not with lesions in esophageal mucosa. Based on~     findings at videoendoscopy GERD patients can have a complicated reflux disease (erosive~     esophagitis) or not and be considered as a non erosive reflux disease (NERD). 60% of GERD~     patients have normal endoscopy (NERD) and requires further studies to achieve a definitive~     diagnosis. Based on this fact is that the study will be focus on NERD patients.~      Recently an image-enhanced endoscopic technology using a pre-processor band-limited light~     called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new~     technology combines digital signal processing with optical filters that limit the spectral~     characteristics of the illumination light. The new innovated optical filters achieve higher~     overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm,~     540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with~     different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of~     microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast~     of white-light observation by bringing the color tone of the overall image closer to that of~     natural color.~      In addition, new scopes has been developed which combines high definition images with~     optical magnification called Magniview™. These scopes increase the image up to 136 times~     with a better quality of image than standard scopes without optical zoom. Sharma et al.~     evaluated esophageal changes in NERD patients using a similar pre-processor filter called~     Narrow Band Imaging (NBI). They found that a significantly higher proportion of patients~     with NERD had an increased number, dilation and tortuosity of the microscopic intrapapillary~     capillary loops (IPCLs), and were considered the best predictors for diagnosing NERD. They~     used optical chromoendoscopy technology (NBI) associated to magnification scopes (Olympus~     GIF Q240Z, 115x), but they did not evaluated if the contribution with this technology to the~     observations found in GERD patients were as a result of the NBI or the magnification scopes.~     The investigators opinion is that chromoendoscopy is useful but is the magnification what~     makes up the difference.~   "
36804|NCT02575274|"~     The purpose of this experimental study in humans is to evaluate and compare, the~     regenerative therapy for the treatment of peri-implantitis using different bone substitutes~     and absorbable membranes with surgical therapy without the use of materials for~     regeneration.~   "
36805|NCT02575261|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in treating with EphA2 positive malignant glioma patients.~   "
36806|NCT02575248|"~     This study aims at investigating the fertility outcome of endometriosis suppression with~     dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in~     endometriosis patients stage I and II.~   "
36807|NCT02575235|"~     This study is to assess the impact on the prevention of sarcopenia after taking~     cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age~     of 60~   "
36809|NCT02575209|"~     Individuals with schizophrenia have important and persistent deficits in multiple~     neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental~     operations underlying social behavior, and it is understood as a multidimensional construct~     that comprises emotional processing (EP), social perspective and knowledge, attributional~     bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two~     most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired~     in chronic schizophrenia patients as well as in patients in early stages of the illness. In~     this context, although negative symptoms may play and important role, females seem to~     perform better than males in ToM and EP tasks, suggesting the presence of gender differences~     in the SC skills in patients with schizophrenia. However, to our knowledge, there are no~     studies that have explored the gender-related differences between cognitive and affective~     ToM and its relationship with the EP performance in schizophrenia patients of recent~     diagnosis comparing with healthy subjects.~      In this line, the main objective of this project is to analyze the influence of gender in~     the cognitive and affective ToM abilities, in a group of patients with schizophrenia in~     early stages of the illness comparing with healthy subjects. Secondarily, this study~     pretends to explore the association between EP skills and affective ToM tasks performance in~     males and females with and without recent diagnosis of schizophrenia.~   "
36810|NCT02575196|"~     Cardiac Arrest is among the leading causes of death, with survival still well under 50% and~     the majority of the survivors suffering from moderate to severe neurologic deficits. The~     human, social and economic costs are staggering.~      During resuscitation, damage is mitigated if chest compressions and other medical care are~     optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the~     heart starts beating again, which is called return of spontaneous circulation, brain~     perfusion is reestablished, but usually not to normal. The now damaged brain is very~     fragile, can be sensitive to any changes in blood pressure or metabolic abnormalities, and~     swelling might set in. Hypoperfusion can persist, without the clinician's knowledge. All of~     these events further damage the brain and diminish the odds that the patient will regain a~     normal life. Therefore, the hours following return to spontaneous circulation are critical~     to the patient's future recovery, and constitute a window of opportunity to maximize the~     brain ability to heal.~      In order to optimize resuscitative efforts and post-arrest management, clinicians must know~     what is actually happening with the most vital organ, the brain. The problem is that it is~     very difficult to do in a comatose patient. The available technologies only reveal indirect~     evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate~     at the bedside if the brain actually receives enough blood.~      The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red~     blood cells in the brain and the speed at which they move to evaluate an index of cerebral~     perfusion. It does so with sensors put on the patient's forehead, which emit and detect~     ultrasounds and infrared light. This index can inform the clinician about the amount of~     blood flow the brain receives, and it can be put in place very quickly, even during~     resuscitative efforts, and without any danger for the patient.~      The study looks at how well the information obtained with the c-flow matches the one~     obtained from other indirect indices and, more importantly, how well it predicts patient~     outcome. The investigators wish to establish threshold values of this index of perfusion~     that predict a good recovery so that this information may be used to optimize patient's~     neurological outcome in the near future.~   "
36811|NCT02575183|"~     The lack of proven waterpipe smoking cessation interventions makes it important to explore~     interventions proven effective for cigarette smoking cessation. The investigators~     hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher~     sustained quit rate at 12 weeks compared to placebo. The investigators propose to conduct a~     randomized double-blind placebo-controlled trial that will evaluate the effect of~     Varenicline (Chantix), in two parallel groups each consisting of 76 habitual waterpipe~     smokers who are willing to quit. Potential participants will be approached in cafés,~     word-of-mouth and through media and will be invited to the American University of Beirut~     Medical Center to complete study procedures. Both study groups will receive the same~     behavioural intervention in combination with either Varenicline (Chantix), an FDA approved~     drug indicated for use as an aid to smoking cessation treatment, or placebo. Participants~     will complete study procedures in four visits. During visit-1 the informed consent process,~     baseline assessments and randomization will be completed and Varenicline (Chantix) or~     Placebo will be initiated together with the behavioural interventions. The behavioural~     intervention will be continued over the next 2 visits. An end of treatment visit 12 weeks~     after quit date will be dedicated to assessing sustained quit rate and other outcomes.~   "
36812|NCT02575170|"~     Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and~     neonates improves neonatal growth. Amino acid before and during anesthesia also prevents~     hypothermia and associated untoward effects.~      Method: After ethical approval, this prospective randomized double blind controlled study is~     being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 & 2)~     undergoing cesarean delivery without fetal distress, intrauterine growth retardation,~     congenital malformation or premature labor will be enrolled.~      For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and~     Group 2 patients will receive 200 ml of amino acid and lactated ringers solution~     respectively at 2 ml/kg/hr. The ambient operating room temperature will be maintained near~     23º C. No heating methods will be applied apart from covering with a blanket.~      Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth.~     Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change~     in rectal temperature relative to baseline and discomfort related to cold sensation in the~     mother and the occurrence of shivering and duration of hospital stay both in the mother and~     newborn.~   "
36813|NCT02575157|"~     Bisphosphonates (BP) are widely used in the prevention and treatment of osteoporosis in~     postmenopausal women and older men. Recently, there has been concern about the risk of~     adverse events after several years of using these agents. This has resulted in a publication~     from the Food and Drug Administration that suggested that, for many individuals, a holiday~     from bisphosphonates might be considered after 4-5 years of continuous use. In that~     publication there was little, if any, guidance on how clinicians should proceed after the~     holiday is initiated.~   "
36814|NCT02575144|"~     This phase III study, open-label, randomized study investigating lenalidomide and~     dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated~     MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of~     either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and~     low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50%~     in the USA (153)~   "
36824|NCT02575014|"~     The primary objective of this study is to assess the safety, tolerability and toxicity of~     preoperative HBOT in patients undergoing a pancreaticoduodenal resection for premalignant~     and malignant tumors of the common bile duct, periampullary and duodenum.~   "
36815|NCT02575131|"~     Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there~     are more overweight than underweight people in the world. This is partly caused by increased~     energy, or food intake. One of the physiological factors regulating the food intake pattern~     is satiety. Though the regulation of food intake has been studied quite extensively, the~     underlying mechanisms are not well elucidated yet and still new factors involved in this~     regulation are being found. Therefore, in this study the investigators aim to develop an in~     vitro screening tool combined with an in silico model for prediction of satiety, for cost-~     and time - effective screening of satiating properties of new and existing complex food~     products and (functional) ingredients, based on actual satiety scores measured. A second aim~     of the Wholegrain Satiety project is to evaluate satiating properties of different types of~     wholegrain breads and other oat based products, both for validation purposes and to~     strengthen the scientific evidence for health benefits of wholegrain products. As part of~     this study, acute satiety scores after consumption of various breakfast products in~     well-controlled clinical conditions will be compared with satiety scores obtained in 'at~     home' test conditions.~      Objective: The current study aims to compare the acute satiety effect of carbohydrate~     breakfast products.~   "
36816|NCT02575118|"~     It has been reported that therapy with polymer-based dental filling materials was associated~     with higher concentrations of bisphenol A in saliva and urine directly after the treatment.~     The objective of the present project is to gain knowledge about the concentration of~     bisphenol A in saliva and urine before and after treatment with polymer-based dental filling~     materials, using sensitive analytical methods.~   "
36817|NCT02575105|"~     We tested the hypothesis that BIS values are altered in pediatric patients with~     hydrocephaly. We also tested the hypothesis that BIS values are altered in adult post~     cerebral hemorrhage patients with hydrocephaly undergoing ventricular-peritoneal shunt~     placement~   "
36818|NCT02575092|"~     Contrast-induced nephropathy has become the third-largest cause of hospital acquired acute~     renal injury, and which morbidity is only less than that of renal hypoperfusion and renal~     toxicity of drugs, about 11%of all cases. Pathophysiologic mechanisms of contrast-induced~     nephropathy(CIN) is not entirely clear yet. May be associated with renal hemodynamic~     changes, medullary ischemia because of renal blood flow reduction, oxidative stress,~     endothelial dysfunction ,contrast agents damage the epithelium of renal tubular directly and~     so on. Currently the studies have proved that inflammation(CRP, TNF-α and NF-қB) played a~     role in CIN.It is well-know that the hyperhomocysteinemia(HHCY) is a independent risk factor~     for cardiovascular diseases, which has pro-inflammatory effects. Researches showed that Hcy~     stimulated CRP generation by the NMDAr-ROS-ERK1 / 2 / p38-NF-қB signaling pathway and~     triggered inflammatory response. We will compare the CIN incidence of different plasma Hcy~     levels in adults hypertensive patients undergoing coronary artery diagnosis and~     treatment(CAG and PCI). CIN was defined as an absolute ≥0.5mg/dl or a relative ≥25% increase~     in the serum creatinine level at 48 hours after the procedure. The relationship between~     decreased plasma Hcy levels and blood pressure values by using Enalapril Maleate and Folic~     Acid Tablets(as the program-based antihypertension) and recovery of CIN has been observed.~     Using univariate and multivariate Logistic regression to analyse the relationship between~     HHcy and CIN, and taking receiver operating characteristic (ROC) curve to select the best~     Hcy plasma levels that which can predict the CIN and the probability. This study will help~     us to understand the relationship between HHcy and CIN that course of the procedure in~     adults hypertensive patients, preoperative plasma Hcy levels can predict the incidence of~     CIN and whether Enalapril Maleate Folic Acid tablets can reduce the CIN of hypertensive~     patients with HHcy. Which has important clinical significance. This study also offer~     feasibility for further research that HHcy plays a role in pathogenesis and specific~     signaling pathways of CIN.~   "
36819|NCT02575079|"~     The purpose of this study is to see if applying parafilm as an external barrier on the~     central line in children having a bone marrow transplant helps to prevent central line~     associated bloodstream infection(s) and also to assess the ease of use of parafilm.~   "
36820|NCT02575066|"~     Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable~     pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5%~     remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1;~     NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg~     oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of~     fibrosis and necrosis in 40% of thus treated patients.~   "
36821|NCT02575053|"~     Study objectives~      Primary objective:~      This study wants to evaluate the safety of a latex safe protocol as proposed by the~     Australasian Society of Clinical Immunology and Allergy. In other words,the investigators~     hope to demonstrate that patients with known latex allergy or latex sensitisation can be~     treated safely in operating theatres without special requirements towards scheduling~     provided that all powdered latex gloves are removed from the OR environment( preparation~     rooms, theatres, recovery room and surroundings). In contrast, earlier guidelines require~     the theatre to be left unused during at least 3 hours before a patient with suspected latex~     allergy can be operated on in this theatre.~      Secondary objectives:~        -  The investigators want to evaluate to what extend patients who report a latex allergy~          show risk factors of latex allergy.~        -  To investigate to what extend latex allergy was proven by laboratory testing or skin~          testing in patients who report a latex allergy.~        -  Type of latex allergic reaction when patients report a latex allergy.~        -  The level of satisfaction of surgeons and OR scheduling staff with the new latex safe~          protocol and with the switching to powder free latex gloves.~   "
36822|NCT02575040|"~     The gut microbiota is determined to constitute a microbial organ which has pivotal roles~     in the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria flora and inflammatory bowel~     diseases. Lots of studies showed its efficacy in treatment of severe Clostridium difficile~     colitis. Corticosteroid dependence in patients with ulcerative colitis (UC) and Crohn's~     disease (CD) is an important clinical problem and maintenance of steroid-free remission is a~     key treatment goal. Early studies using fecal microbiota transplantation (FMT) for~     Ulcerative Colitis (UC) and Crohn's diseases have also met with success. This is an first~     step into investigating the potential efficacy of standardized FMT through terminal ileum~     for UC and CD, the investigators propose to determine the efficiency and safety of FMT in a~     series of 80 patients with moderate to severe UC and CD.~   "
36823|NCT02575027|"~     This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating~     patients with glioblastoma multiforme that has come back after standard chemoradiation. A~     new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve~     radiation delivery by improving dose coverage to the treatment target, while reducing the~     dose to surrounding normal tissues.~   "
36825|NCT02575001|"~     The aims of this study are two fold: To show whether there is an increased environmental or~     genetic susceptibility to stress in patients with T1D and whether it influences diabetes~     management. And to develop a strategy for the assessment and treatment of patients with T1D~     and an increased risk for development of psychopathology under stress.~   "
36826|NCT02574988|"~     The multicenter registry of patients with severe cutaneous adverse reactions among tertiary~     medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic~     outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the~     confirmation of the causative drugs~   "
36827|NCT02574975|"~     Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable~     symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow~     limitation and often associated with airway hyper-responsiveness and airway inflammation.~     About 1-18% of the global population suffered from the disease, causing huge economic burden~     for patients and countries. Airway reactivity measurement is an important way of diagnosis~     of asthma. Methacholine (Mch) bronchial provocation test(BPT) is the gold standard for the~     determination of airway reactivity, and other measuring methods(like adenosine~     monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought~     into hot research fields. The investigators' purposes were to compare different kinds of~     methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to~     investigate treatment efficacy of budesonide /formoterol in asthmatics.~   "
36828|NCT02574962|"~     The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in~     Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.~   "
36829|NCT02574949|"~     The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5~     frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and~     15 PPS) on radiation dose to the patient and the operator during coronary angiography and~     intervention. In addition, investigators sought to qualitatively assess the effect, if any,~     of the low frame rate on angiographic image quality.~   "
36830|NCT02574936|"~     The purpose of this study is to reduce the volume of dead space by a modification in~     kardakis flap procedure and consequently, to reduce the use of drains, wound drainage,~     seroma and hematoma formation, skin degradation and recurrence rates.~   "
36831|NCT02574923|"~     The aim of this study is to assess the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in patients with cerebral palsy.~   "
36832|NCT02574910|"~     Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to~     have elevated circulating levels of androgens, which can accelerate skeletal maturation and~     adversely impact adult height. Additionally, these children require supraphysiologic doses~     of hydrocortisone to suppress secretion of adrenal androgen precursors, and this treatment~     can retard linear growth. This study seeks to use oral abiraterone acetate (Zytiga)as an~     adjunct to approved CAH therapy (oral hydrocortisone and fludrocortisone) for pre-pubescent~     children with classic 21-hydroxylase deficiency in order to reduce daily requirement of~     hydrocortisone. In this Phase 1 study, the investigators will determine the minimum~     effective dose of abiraterone acetate that normalizes androstenedione levels during the~     7-day Treatment Period.~   "
36833|NCT02574897|"~     The purpose of this randomized trial will evaluate whether providing clinicians with daily~     reports from a well-validated, standardized, patient-centered electronic symptom survey tool~     (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult~     inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to~     stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm~     with standard of care daily clinician interviews or (2) standard of care plus daily~     electronic symptom surveys, the results of which will be sent to clinicians electronically.~   "
36834|NCT02574884|"~     The study consists to Identify viral variants involved in the transmission of hepatitis C~     and characterize the antigenic and functional properties of their envelope glycoproteins at~     very early stage of infection (before seroconversion).~   "
36835|NCT02574871|"~     This study consists of psychological and biological data collection for identification of~     the chronic stress presence in healthy adult subjects. The psychological data collected were~     the results provided by three different instruments: ISSL, PSS and SRRS. The biological data~     collected were the blood pressure, the skin temperature, the galvanic skin response, and the~     heart rate variability in time and frequency domain.~   "
36836|NCT02574858|"~     The purpose of this study is to evaluate the safety of orally administered QRH-882260, a~     topically administered Cy5-labeled heptapeptide specific for epithelial growth factor~     receptor (EGFR).~   "
36837|NCT02574845|"~     The primary objective of this trial is to investigate the relative bioavailability of~     rosuvastatin when given alone (Reference treatment, R) compared to when given together with~     one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500~     mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).~   "
36838|NCT02574832|"~     Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with~     cervical incompetence are at risk for second trimester spontaneous abortion and preterm~     labor. Cervical cerclage reduces these risks but must be performed under general or~     neuraxial anesthesia. Some anesthesiologists prefer neuraxial anesthesia, as it reduces~     fetal exposure to medications and avoids the risks associated with loss of maternal airway~     reflexes under general anesthesia. Spinal anesthesia, in particular, has the added advantage~     of being technically simple while still providing a rapid, dense sensory block. For cerclage~     placement, patients require a sensory block from the T10 to S4 dermatome in order to cover~     sensation from the cervix as well as the vagina and perineum. Patients presenting for~     cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes~     associated with pregnancy. As women progress with their pregnancy, they require lower doses~     of intrathecal local anesthetic to achieve similar block level. Multiple studies have~     demonstrated that these changes start during the second trimester. Inadequate sensory~     coverage with a spinal anesthetic typically necessitates conversion to general anesthesia,~     causing additional time wasted and added risk to the patient and fetus. Anecdotally, this is~     the reason why some anesthesiologists choose general anesthesia for patients undergoing~     cerclage over a spinal anesthetic. As there is currently no literature determining the~     correct dosage for these patients, we propose a dose-response study to determine the ED90 of~     intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.The~     findings of this study will help determine the minimum dose of intrathecal lidocaine~     necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. This~     will help decrease the frequency of inadequate anesthesia for cervical cerclage.~   "
36839|NCT02574819|"~     This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate~     the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced~     constipation in patients with advanced illness.~   "
36840|NCT02574806|"~     Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and~     prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP~     plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and~     diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as~     expression of renal maturity could explain the subsequent decrease in serum values. This~     would suggest that, in healthy newborns, BNP values should be found within a given ranges.~     However, the evidence suggests an important variability in BNP values 2 - 4. In the other~     hand, in the newborn with respiratory distress BNP could have a high negative predictive~     value to rule out acute myocardial processes, as responsible for clinical deterioration,~     from infectious, metabolic or respiratory processes; with a potential of improvement in~     medical care. Even the increased use of this biomarker in clinical practice, until our~     knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the~     investigators performed a pioneer study to establish normal values in healthy newborn~     population. Multi-center, prospective and observational study was carried out. Objective: To~     establish normal BNP values in healthy newborn.~   "
36841|NCT02574793|"~     Glucose fluctuations present not only in patients with diabetes mellitus but also in~     subjects with normal glucose tolerance or impaired glucose regulation. People with Growth~     Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose~     metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim~     of the study is to investigate the characteristics of glucose fluctuations in the newly~     diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.~   "
36842|NCT02574780|"~     The stage and lymphedema size can be detrimental to the quality of life and health of women,~     because the increase in circumference and member of the weight causes limitations in~     activities. Previous studies have shown that patients with lymphedema should not perform~     high intensity exercises, these exercises would cause the increase of lymphedema. Already,~     in current studies show that muscle strength exercises when properly applied, with~     controlled intensity and time, can help to reduce lymphedema. Thus, the main objective of~     this study is to compare the standard treatment of lymphedema through complex physical~     therapy versus the application of strengthening exercises for upper limbs together with~     complex physical therapy. The study design is a randomized controlled clinical trial.~     Participate in the study 50 patients, who will be allocated into two groups, group 1 (n =~     25): Complex Physical Therapy; Group 2 (n = 25): Complex physical therapy in an exercise~     protocol, which will receive treatment twice a week for eight weeks. All patients will~     receive treatment and will be informed of the free and informed consent form at the~     beginning of the research. They will be met: the report cards, dynamometer testing and~     filling out questionnaires at the beginning and end of the study.~   "
36843|NCT02574767|"~     In Chile, 1 out of 4 pregnant women is obese (BMI > 30 kg/m2). This impacts negatively the~     health of the mother and the offspring during pregnancy. Lifestyle interventions are the~     primary prevention strategy for gestational diabetes in obese women; however, these~     interventions have shown null or limited effectiveness. In animals, n-3 long-chain~     polyunsaturated fatty acid (n3LC-PUFAs) have shown to increase insulin sensitivity through~     higher production and secretion of adipokines, enhanced fatty acids oxidation, reduction of~     lipogenesis, and direct anti-inflammatory effects; however evidence in humans and during~     pregnancy is still very limited. Combining a lifestyle intervention with n3LC-PUFAs~     supplementation could enhance the metabolic control of obese pregnant women. Objective: to~     assess the effectiveness of two prenatal nutritional interventions (home-based diet and~     physical activity counseling and/or n3LC-PUFAs supplementation) delivered to obese pregnant~     women in achieving better metabolic control in both the mother (lower incidence of~     gestational diabetes mellitus) and the offspring (lower incidence of macrosomia and lower~     prevalence of insulin resistance at birth).~      Methods: this study is a cluster-randomized trial in which obese pregnant women from 12~     primary health care centers (PHCC) will be stratified by socio-economic status (SES) and~     randomized to one of four parallel study arms. We will recruit 1000 women allocated to: 1~     Home-based Diet and physical activity (PA) plus n3LC-PUFAs supplementation (Intervention~     Group 1, n=250); 2. Routine diet & PA counseling care plus n3LC-PUFAs supplementation~     (Intervention Group 2, n=250); 3. Home-based Diet and Physical activity plus placebo for~     n3LC-PUFA supplementation (Intervention Group 3, n=250); 4. Routine diet & PA counseling~     plus placebo (Control Group, n=250). Expected results: we expect that the intervention will~     contribute to achieving a better metabolic control during pregnancy. Ultimately, we expect~     that this study will contribute to advance the understanding of how to develop and implement~     effective actions to promote healthier pregnancies and therefore, healthier lives for~     mothers and their offsprings.~   "
36844|NCT02574754|"~     The purpose of this study is to assess the 2012 bioequivalence statistical criteria for~     warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the~     Food and Drug Administration (FDA).~   "
36845|NCT02574741|"~     The study will consist of two main elements: the enrollment of 72 children aged 6-11 years~     with ASD and low language competency to receive a thrice-weekly one hour language~     intervention for 12 weeks; and, beginning at the same time, subjects will be equally~     randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or~     placebo for 12 weeks.~   "
36846|NCT02574728|"~     This study aims to determine the efficacy of daily sirolimus and celecoxib, with low dose~     etoposide alternating with cyclophosphamide for pediatric participants with relapsed or~     refractory tumors.~   "
36847|NCT02574715|"~     This is a cross-sectional, multicenter observational study to assess quality of life in~     young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The~     study will be conducted in standard clinical practice conditions at the private gynecology~     clinics and during a single study visit.~      Approximately 1,200 women who have been using the intrauterine delivery system (IUS)~     Jaydess® as their contraceptive method of choice for 6 (±1) months will be included in the~     study.~   "
36848|NCT02574702|"~     1. Introduction:~           The most common complication of loop ileostomies closure for rectal cancer patients~          undergoing a low anterior rectum resection, is the superficial surgical site infection~          (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a~          retrospective study at our center, the investigators objectify that superficial~          surgical site infection rate was reduced by more than a half by the application of a~          contralateral drainage (Penrose ®) in primary loop ileostomy closure.~        2. Objectives and Hypothesis:~           Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop~          ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for~          rectal cancer) reduces the superficial surgical site infection.~           Main objective: To reduce the rate of superficial surgical site infection by the~          application of a contralateral drainage (Penrose ®) in surgical wound of primary loop~          ileostomy closure.~        3. Methodology:~      Prospective and randomized clinical trial on the effectiveness of contralateral Penrose®~     drainage implementation in those patients that have a primary loop ileostomy (by low~     anterior rectum resection) closure to be able to know if the investigators can reduce the~     superficial surgical site infection rate. Monitorization until 30 days after surgery~   "
36850|NCT02574676|"~     This is an online registry to document the psychometric properties of SF-36v2 among patients~     with AL Amyloidosis, to document patients' burden of disease, to better understand the~     patient's experience and to follow quality of life issues using a variety of QOL measures.~   "
36851|NCT02574663|"~     This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a~     single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients~     with select relapsed or refractory solid tumors.~   "
36852|NCT02574650|"~     The purpose of this study is to assess the early safety and performance of the Mitralign~     Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic~     chronic functional tricuspid regurgitation (FTR).~      The procedure will be performed with the PTVAS device using a non-surgical percutaneous~     approach to tricuspid valve repair in patients who have FTR with a minimum of moderate~     tricuspid regurgitation.~   "
36853|NCT02574637|"~     A Phase 2b study to evaluate the efficacy and safety of MEDI2070 in Subjects with Moderate~     to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis~     Factor-Alpha Therapy~   "
36854|NCT02574624|"~     To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify~     and document with video evidence and surgeon's case report forms intraocular maneuvers that~     are facilitated by VISIA.~   "
36855|NCT02574611|"~     An injury to the spinal cord (SCI) results in numerous medical complications, including~     gastrointestinal (GI) function. Individuals with SCI may experience severe constipation~     (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel~     evacuation. While various treatments and medications have been established to address this~     complication, there is little knowledge relating to the overall colonic motility. However,~     new technology such as High Resolution Colonic Manometry allows physicians to visualize high~     pressure contractions inside the colon, leading to a greater understanding of typical~     motility, a more accurate diagnosis, and an effective treatment. In this study, the~     investigators propose to use this technology to understand the effects of SCI on colonic~     motility by comparing to normal colonic function observed in able-bodied (AB) individuals.~     In addition, the investigators plan to study the effects of pharmacological treatments, such~     as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across~     the skin.~   "
36856|NCT02574598|"~     This is a phase II open-label randomized clinical trial of MK-3475 (Pembrolizumab) on~     previously treated PDL1 positive non-small cell lung cancer (NSCLC) patients . This drug has~     shown to allow partial response according to the immune-related response criteria and the~     response evaluation criteria in solid tumors (RECIST). The main endpoint is to compare the~     overall response rate (ORR) of MK-3475 with docetaxel or docetaxel alone in patients with~     advanced NSCLC.~   "
36857|NCT02574585|"~     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow~     mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete~     spinal cord injury.~   "
36858|NCT02574572|"~     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow~     mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal~     cord injury.~   "
36859|NCT02574559|"~     The purpose of this study is to determine if caregivers of children with a developmental~     delay experience a decrease in stress by participating in a meditation/cognitive training~     protocol.~   "
36860|NCT02574546|"~     This research is being done to learn more about the risk of developing breast cancer by~     studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to~     study cells, genes, and gene products to help us to learn how to detect cancer in its~     earliest stages, and if this information may differ in patients with different ethnic~     backgrounds.~   "
36861|NCT02574533|"~     This is an open label Pilot study to evaluate the combination of Vigil™ and pembrolizumab in~     patients with incurable locally advanced or metastatic melanoma. Patients undergoing a~     standard of care surgical procedure (e.g., tumor biopsy, palliative resection) and meeting~     procurement eligibility criteria may have tumor harvested for Vigil™ vaccine manufacture.~     This study evaluates the hypothesis that vaccination with Vigil™ will induce cancer-specific~     T cell immunity in these patients. Addition of pembrolizumab to Vigil™ treated patients will~     further augment these immune changes on sequential biopsy when comparing post-Vigil™ but~     pre-PD-1 inhibitor to post-PD-1 inhibitor biopsies, and the combination therapy will be~     associated with reduction of tumor volume on clinical exam and/or imaging.~   "
36862|NCT02574520|"~     This is a research study of SABER® -Bupivacaine, an experimental medication designed to~     relieve pain for up to 3 days after surgery. Given once by the surgeon at the end of~     surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the~     surgical wound.~      The purpose of this study is to measure how well it works in reducing pain after~     laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the~     safety of SABER®-Bupivacaine (its side effects).~   "
36863|NCT02574507|"~     The objective of the study is to develop and test the feasibility, acceptability, and~     initial efficacy of a novel couples-based behavioral weight and symptom management~     intervention for obese breast cancer survivors and their partners. The proposed project~     consists of two phases. Phase I will include intervention development and refinement.~     Intervention development will be guided by the research team's prior work, the~     interdependence model of communal coping and behavior change, and information obtained from~     couples participating in focus groups. The intervention protocol will then be tested with 5~     couples to assist with refinement of intervention content. During phase II, the feasibility,~     acceptability and initial efficacy of the intervention will be examined. Obese breast cancer~     survivors in the first year following treatment and their overweight or obese partners will~     receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across~     approximately 5 months. The intervention will be provided in a couples-based format where~     each couple will meet separately with the therapist. Couples will be assessed at pre-,~     post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain,~     fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine~     biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health~     outcomes for cancer survivors and their partners. It is hypothesized that the intervention~     will be feasible (i.e., completed sessions), and participants will find the intervention~     acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that~     participants will evidence decreased weight and improvements in symptoms (i.e., pain,~     fatigue, distress), eating behavior, and physical activity, and their change in weight will~     covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is~     hypothesized that participants with greater weight loss will evidence improved functioning~     in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.~   "
36864|NCT02574494|"~     The primary aim is to establish whether breastfeeding is associated with lowering blood~     pressure in hypertensive women.~   "
36926|NCT02573688|"~     The aim of the research study will be assess the effectiveness of a long-term~     interdisciplinary lifestyle in many aspects including food intake, psychological symptoms,~     physical activity habits, energy expenditure, body composition and anthropometric~     measurements in adults obese.~   "
36865|NCT02574481|"~     The primary objective of this trial is to evaluate the safety and effectiveness of the~     Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent)~     for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions~     up to 140 mm in length.~      Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific~     Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating~     Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and~     ≤ 190 mm in length.~   "
36866|NCT02574468|"~     Abstract Aim The aim of this randomized clinical trial was to histologically investigate~     possible effects of dexamethasone application on pulp tissue healing during one step mineral~     trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy~     human premolar teeth.~      Methodology Forty intact premolar teeth of 10 orthodontic patients, scheduled for~     extraction, were randomized for DPC (n=20) or MP (n=20). A high speed bur under copious~     water coolant was used for mechanical exposing of buccal pulp horn site. Prior to sealing~     with white ProRoot MTA, 10 out of twenty pulpal wounds of each group were randomly received~     dexamethasone. Cavities were restored with glass ionomer. Teeth vitality was evaluated in 7,~     21, 42, and 60 day follow-ups. Signs and/or symptoms of irreversible pulpitis or pulp~     necrosis were considered as failure. After 60 days, the teeth were extracted and submitted~     for histological examination. Kruskal-Wallis and Fisher exact tests were used for~     statistical analysis of the data (P=0.05).~      HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda~   "
36867|NCT02574455|"~     This is an international, multi-center, open-label, randomized, Phase III study in patients~     with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies~     (including a taxane) for their metastatic disease. Patients meeting eligibility will be~     randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice~     (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens.~     Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3~     vs > 3) and geographical location (North America vs Europe).~      Patients will be treated until progression, unacceptable toxicity, study withdrawal, or~     death, whichever comes first. Tumor progression leading to treatment withdrawal will be~     assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or~     TPC, CT scans (or MRI if contrast allergic) will be obtained at least every 8 weeks until~     the occurrence of progression of disease requiring discontinuation of further treatment.All~     patients, including those prematurely terminating study participation, will be followed~     every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.~   "
36868|NCT02574442|"~     The goal of this proposal is to determine whether a hand-held confocal microscopy probe may~     perform better than standard methods in detecting cancer or pre-cancerous abnormalities of~     the cervix. The confocal probe will provide invivo histopathology-like images of cell~     morphology and three-dimensional tissue architecture non-invasively in real time.~   "
36869|NCT02574429|"~     Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)~     commonly co-occur, few studies have examined PTSD treatment among individuals with BPD.~     Additionally, many PTSD research studies exclude individuals with BPD due to their~     complexity and concerns regarding risk. This study aims to investigate the effectiveness of~     Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals~     with these co-occurring disorders following completion of a Dialectical Behavioural Therapy~     Program (an evidenced-based treatment for BPD). The investigators are using a repeated~     measures pre and post design. Data will be collected prior to participants starting the CPT~     group, throughout the duration of the CPT group (i.e., weekly), and following the completion~     of the CPT group.~   "
36870|NCT02574416|"~     Although increasing age is associated with declining health and function, there are wide~     variations between individuals in the ageing process. Some of these differences are~     explained by differences in lifestyle, but little is known about the determinants of~     lifestyle in older age. The proposed project will describe influences on health behaviour~     and lifestyle in older adults. Investigators will undertake a prospective study of~     community-dwelling older people who use any of the Medicine for Older People Services in~     Southampton, allowing us to gain obtain important insights into the relationship between~     health behaviour, lifestyle and health outcomes in older people. Our principal aim is to~     identify key points on the ageing pathway when interventions may be best targeted to promote~     health. The findings of this project will underpin the design for a complex intervention to~     be conducted in the future to improve the health outcomes of older people.~   "
36871|NCT02574403|"~     Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults.~     It is characterized by the occlusion of intrarenal vessels due to the presence of~     platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The~     discovery of complement alternative pathway as a major risk factor for aHUS has led to the~     design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab.~     Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS~     patients with a dramatic decrease in the risk of end-stage renal disease. However, the~     optimal duration of eculizumab therapy is still debated. The present study aims to assess~     the feasibility and safety of the discontinuation of eculizumab treatment in children and~     adults with aHUS.~   "
36872|NCT02574390|"~     Creation of a large repository of induced pluripotent stem cells (iPSC), bio-fluid samples~     (blood and spinal fluid (optional)), and cell lines for ALS gene identification. This will~     be combined carefully with collected measures of the pattern of the symptoms people with ALS~     have and how these change over time.~   "
36873|NCT02574377|"~     This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC~     vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.~   "
36874|NCT02574364|"~     The traditional open appendectomy in the clinical effect is not prefect, and for a long time~     there is no measurable improvement. The application of abdomen CT before surgery provides a~     new approach to the incision and new perception.~      In a randomized controlled trial of modified incision versus traditional incision. Length of~     hospital day was the primary terminus, while operating time, postoperative complication,~     scar and time to resume normal activity and work as secondary terminus.~   "
36875|NCT02574351|"~     To study whether the immune response as directed by regulatory T cells is different between~     obese asthmatics, normal weight asthmatics and healthy controls.~   "
36877|NCT02574325|"~     Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of~     ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic~     fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty~     liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To~     investigate the safety and tolerability of a 24-week, twice daily dosing regimen of~     ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.~   "
36878|NCT02574312|"~     This post-marketing investigation will evaluate the mechanical axis alignment achieved with~     the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment~     achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee~     Arthroplasty.~   "
36879|NCT02574299|"~     The ability to encode the speech signal is determined by ascending and descending auditory~     processing. Difficulties in processing these speech signals are well described at the~     behavioral level in a specific language disorder. However, little is known about the~     underlying pathophysiological mechanisms. The assumption is that we should observe a~     degradation of the signal provided by the ear in the deaf subject while in case of specific~     language impairment it would be a phonemic disorder (possibly linked to a processing~     disorder auditory). The two population groups should therefore have different abnormalities~     of their central auditory process - which could be modified by the target remediation for~     each group.~   "
36880|NCT02574286|"~     To evaluate the effect of VPRIV® therapy on patients with type 1 Gaucher disease by~     measuring the change in the lumbar spine (LS) and bone mineral density (BMD) after 24 months~     of treatment.~   "
36881|NCT02574273|"~     Several independent evaluations have supported the effectiveness of the Secret Agent Society~     (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum~     Disorders (ASD) in clinic- (Beaumont & Sofronoff, 2008; Tan, Mazzucchelli & Beaumont,~     submitted), school-(Beaumont, Rotolone & Sofronoff, in press; Einfeld et al., submitted) and~     remote Skype/telephone-assisted delivery contexts (Sofronoff, Silva & Beaumont, in~     press).The present study aims to extend on the above literature by conducting a 6-month~     randomized controlled trial evaluating the effectiveness, utility and acceptability~     (including cultural acceptability) of the Secret Agent Society (SAS) social-emotional skills~     training program. Specifically, the study aims to evaluate the effectiveness of the SAS~     Program for 8-12 year-old children with social difficulties in the context of a range of~     diagnosed mental health conditions and/or developmental disorders, including anxiety~     disorders, ADHD, and Autism Spectrum Disorder.~   "
36882|NCT02574260|"~     The primary objective of this extension study was to further assess the safety and~     tolerability of talimogene laherparepvec. Secondary objectives were to assess objective~     tumor response rate and survival.~   "
36883|NCT02574247|"~     The purpose of this study is to determine how changes in speech perception resulting from a~     computerized auditory training program are related to concurrent changes in auditory~     brainstem function resulting from the training. It is hypothesized that the degree of~     improvement in speech perception will be correlated with the degree of change in brainstem~     function.~   "
36884|NCT02574234|"~     No successful strategy is proposed to patients submitted to important surgery to reduce the~     incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure~     plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be~     involved in anti-inflammatory processes. Apelin levels before and after surgery correlated~     to postoperative cognitive disorders symptom measured by PET-Scan could be an important~     predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative~     cognitive disorders.~   "
36885|NCT02574221|"~     This study is to evaluate the sensitivity of the molecular method and its ability to split a~     stannous fluoride toothpaste versus a negative control.~   "
36886|NCT02574208|"~     CDC recommends universal HIV testing in all adults, at least once during life, to reduce the~     pool of infected patients unaware of their status. Routine universal HIV testing can use~     classical ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood~     (FSB), which have shown close predictive values from classical tests. The investigators will~     compare the acceptability and feasibility of the two methods.~   "
36887|NCT02574195|"~     The main aim of the present study is to evaluate the prevalence of individual microvascular~     and macrovascular complications among diabetes mellitus patients and to determine the~     percentage of diabetes mellitus patients achieved HbA1c<7,0%.~   "
36888|NCT02574182|"~     Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in~     healthy subjects and amnesic MCI.~   "
36889|NCT02574169|"~     This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral~     injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.~   "
36890|NCT02574156|"~     The investigators aim to study the impact of a strategy of a intensive glycemic control in~     patients undergoing cardiac surgery.~   "
36891|NCT02574143|"~     The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and~     to provide an estimate of the distribution (prevalence) of NCFB etiologies across all~     different levels of health care as well as real-life data regarding the current management~     of NCFB in Germany.~   "
36892|NCT02574130|"~     The purpose of this study is to determine the cure rate from ventilator-associated pneumonia~     (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to~     intravenous antibiotics compared to intravenous antibiotics alone.~   "
36893|NCT02574117|"~     Maxillary expansion was performed for adult female patients suffering from maxillary~     constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about~     8 months. The appliance was delivered and activated at the day of corticotomy and bone~     graft. The activation was made half-molar unit each side. The patient was scheduled each~     month to activate the appliance or reactivate if needed. Corticotomy was performed at area~     of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was~     performed, before appliance activation and corticotomy, at the end of expansion (8 months)~     and after finishing orthodontic treatment (average 2.5 years from start of treatment).~   "
36948|NCT02573402|"~     The purpose of this research study is to evaluate the effects upon the bladder of electric~     stimulation of the leg's tibial nerve in people with acute spinal cord injury with an~     intervention called transcutaneous tibial nerve stimulation (TTNS).~   "
36894|NCT02574104|"~     Complex service interventions are neither smooth nor easy in any transitioning healthcare~     facility. Simulations performed in the new environment reinforce patient safety by~     uncovering safety threats, enabling their correction, and orienting hospital staff. This~     study expands upon patient safety successes at several institutions to measurably enhance~     patient safety at upcoming new inpatient facilities.~   "
36895|NCT02574091|"~     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of~     Icotinib Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.~   "
36896|NCT02574078|"~     The purpose of this study is to determine whether nivolumab monotherapy or in combination~     with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR)~     without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.~   "
36897|NCT02574065|"~     Infant colic is a common condition characterized by excessive crying. The otherwise healthy~     infant aged less than 3 months is difficult to console during the periods with crying. The~     condition is defined by modified Wessel's criteria i.e. crying for more than 3 hours of the~     day, for more than 3 days of the week for at least 1 week.~      The description of infant colic hasalso been defined by Rome III diagnostic criteria~     andincludes infants from birth to 4 months of age,without failure to thrive, that are~     showing paroxysms of irritability, fussing or crying that starts and stops without obvious~     cause. The episodes last 3 or more hours/day and occur at least 3days/week for at least one~     week. The infant has no signs of central nervous system or intrinsic developmental~     difficulties, is normal on physical examination, and has normal growth patterns.~      Although infant colic is considered to be self limiting it is a distressing problem for~     families. It is in fact one of the most common reasons why parents seek the advice of a~     paediatrician or family practitioner during their child's first 3 months of life Up to 20%~     of infants under three months are affected by infant colic.~      Infant colic could have significant adverse effects on family quality of life and could even~     be a trigger for shaken baby syndrome. Parental perception associated with colicky~     complaints is therefor strongly recommended to be an outcome measure in trials of infantile~     colic.~      Measurement of parental/family quality of life and parental perception of colic severity~     with the help of a Visual Analogue Scale (VAS) in a Polish study showed that the use of a~     probiotic, Lactobacillus reuteri DSM 17938, could improve the perceived problems.~      The relationship between infant colic and gastroenterological, allergical and psychological~     disorders later in childhood was studied in a prospective study on 96 infants divided into~     two groups, colicky and non-colicky. The children diagnosed with infant colic, showed an~     increased susceptibility to recurrent abdominal pain, allergic and psychological disorders~     in childhood when they were 10 years old.~      The aetiology of infantile colic seems to be multifactorialbut is,despite many years of~     research, still unknown. The intestinal microbiota differs between infants with and without~     colic and has therefore been suggested to have a potential role. Other possible explanations~     are for example gut motility disturbances, low-grade mucosal inflammation and visceral~     hypersensitivity.~      Evidence suggests thatadministration of the probioticL. reuteri DSM 17938 might offer some~     benefit.L. reuteri DSM 17938 has been tested for its effect on crying in colicky infants and~     has been demonstrated to have a significantly favourable effect on crying time in~     fivetrials. One is a randomized trial that compared the probioticto Simethicone; three~     areplacebo controlled randomized double blind trials and yet another is a placebo controlled~     randomized, single blind, observational study. A fifth studydid not find any effect.~      Combining the results in a meta-analysis from three double blind, placebo controlled~     randomized trials (published at the time of the analysis, including the neutral one) found~     that, compared with placebo, L. reuteri administration reduced crying time at day 21 with~     about 40 min.~      Recently it has been documented in a clinical trial that prophylactic use of L. reuteriDSM~     17938during the first three months of lifereduced the onset offunctional gastrointestinal~     disorders, particularly functional constipation, regurgitation and infantile colic.~      In conclusion, the administration L. reuteri DSM 17938 may reduce the crying time in~     children with infantile colic, especially those fed predominantly or exclusively with breast~     milk. However, further randomized controlled studies, are required to be able develop~     recommendations in the management of infant colic.~      The present trial is undertaken to further document the effect of L. reuteri DSM 17938 on~     crying in colicky infants.~   "
36898|NCT02574052|"~     The purpose of this study is to evaluate whether exposure to nutrition information with or~     without nutrition education would influence college students' dietary choices and improved~     the previous photographs-based dietary assessment tools.~   "
36899|NCT02574039|"~     A diet rich in whole grain is inversely associated with cardiovascular disease risk and this~     benefit could be partly attributed to the phenolic acid content of whole grains. The exact~     absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully~     understood. In a small human intervention trial, the investigators will investigate to what~     extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are~     metabolised.~   "
36900|NCT02574026|"~     The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal~     volunteers by tapping the finger .~   "
36901|NCT02574013|"~     To achieve an adequate visual working field during laparoscopic colorectal surgery without~     disturbance of the small intestine, patients are positioned in Trendelenburg position. This~     position results in hemodynamic changes which may increase the risk of cardiopulmonary~     complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was~     introduced as alternative for the Trendelenburg position during laparoscopic surgery.~   "
36902|NCT02574000|"~     This is an observational study to address the following questions.~        1. How many people develop stroke-shoulder pain within 3 days of stroke?~        2. How many people have stroke shoulder pain at 8-10 weeks after stroke?~        3. Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of~          having stroke-shoulder pain at 8-10 weeks?~        4. What are the best bedside examination tests to identify stroke-shoulder pain?~   "
36903|NCT02573987|"~     detremine if efficiency of MEOPA anesthesy is at least equivalent to local anesthtics into~     the chorionic villus sampling in the first trimester of pregnancy~   "
36904|NCT02573974|"~     Undernutrition associated with cancer, or cancer cachexia results from a deterioration of~     the energy balance that leads to a gradual mobilization of energy reserves in the body and~     to increasing deterioration of the nutritional status of patients. This will thus~     significantly reduce quality of life and survival of patients with a lower tolerance to~     cancer treatments. Despite undeniable progress in knowledge, many pathophysiological~     mechanisms remain few or not explored, which could explain that there is still no~     satisfactory therapeutic solution to halt the gradual deterioration of the nutritional~     status of patients. In this sense, apart from preclinical data obtained in animal models,~     there is currently no clinical study on the functioning of skeletal muscle energy metabolism~     in undernourished patients suffering of cancer.~   "
36905|NCT02573961|"~     The purpose of this study is to compare the effects of laser acupuncture and high protein~     low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.~   "
36906|NCT02573948|"~     This study aims at assessing the feasibility of implementing an interventional cohort of~     people who inject drugs in Haiphong, Viet Nam.~      For this purpose, the investigators will conduct a RDS survey to i) assess the current~     situation of drug use behaviour, HIV and Hepatitis C Virus (HCV) infection in the study~     population and ii) recruit participants for the longitudinal phase. The latter will consist~     of enroling the most difficult to reach People Who Inject Drugs (PWID) (those not followed~     by health centers), including early injectors, Men who have Sex with Men (MSM) and female~     sex workers (FSW) and following them up for 6 months in order to estimate the follow-up rate~     and preliminary estimates of HIV and HCV incidence.~   "
36907|NCT02573935|"~     This study evaluates the potential synergic anti-myeloma activity of clarithromycin when~     combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.~   "
36908|NCT02573922|"~     In the present study, the primary aim was to evaluate if oxycodone-naloxone combination~     compared to oxycodone reduced opioid induced constipation in patients with or without~     chronic opioid treatment undergoing spine surgery.~   "
36909|NCT02573909|"~     There are conflicting results in earlier studies concerning the safety and efficacy of~     epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as~     effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In~     another study, Yanagidate and Dohi reported that oxycodone was as effective in pain~     treatment with double dose compared to epidural morphine. In our previous study, epidural~     oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.~      In the present study, the aim was to compare the efficacy and safety of epidural or~     intravenous oxycodone in patients undergoing elective gynecological surgery with planned~     epidural pain treatment.~   "
36910|NCT02573896|"~     This NANT trial will determine the maximum tolerated dose (MTD) of autologous expanded~     natural killer (NK) cells when combined with standard dosing of ch14.18 and will assess the~     feasibility of adding lenalidomide at the recommended Phase II dose of the expanded NK cells~     with ch14.18, for treatment of children with refractory or recurrent neuroblastoma.~   "
36911|NCT02573883|"~     This study is being done to compare the effects, good and bad, of radiofrequency laser~     treatment and clobetasol proprionate .05% ointment on vulvar lichen sclerosus.~   "
36925|NCT02573701|"~     The purpose of this study was to evaluate the applicability and usefulness of the guideline~     treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate~     the compliance to the treatment according to the guidelines, and to compare the treatment~     compliance, severity of illness and social functioning of patients treated according to~     guideline treatment vs patients with the treatment as usual on a six month follow up.~   "
36912|NCT02573870|"~     Batefenterol inhalation powder is currently under development as a fixed-dose combination~     with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease~     (COPD).~      The present study will administer batefenterol/FF (300/100 micrograms [mcg]) for the first~     time to subjects with COPD, to investigate the safety and tolerability of the combination~     compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of~     the individual components when administered in combination.~      This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel~     group study. Subjects will be randomized (2:1) to one of the following double-blind~     treatment groups:~      Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation~     powder once daily.~      Subjects will self-administer the study treatments once daily (QD) in the morning for 42~     days via a multi-dose dry powder inhaler (DPI) which contains two blister strips.~     Additionally, an inhaled short acting beta2-receptor agonist, albuterol will be provided~     from screening to the end of the treatment period for all subjects to use as needed to~     relieve COPD symptoms. At the end of the treatment period, subjects can resume conventional~     therapy.~      The study will randomize approximately 60 subjects. The total duration of subject~     participation (from screening to follow-up) will be approximately 8 weeks.~   "
36913|NCT02573857|"~     Part A~      -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an~     additional single dose (400 mg) of DSM265 may be given if gametocytemia develops. Treatment~     with DSM265 will be given after an overnight fasting period of ≥ 8 hours. If dosing is to~     occur in the evening, subjects will be required to fast for ≥4 hours prior to receiving~     treatment. Subjects will be required to fast for a further four hours anytime after dosing~     with DSM265.~      Part B~        -  Cohort 2 OZ439 will be administered as a single 200 mg dose. If recrudescence is~          observed, a single 400 mg dose of OZ439 will be given. Treatment with OZ439 will be~          administered after an overnight fasting period of ≥ 6 hours. If dosing is to occur in~          the evening, subjects will be required to fast for ≥4 hours prior to receiving~          treatment. Participants will drink 200 mL of milk prior to drug administration, and~          then swallow the appropriate volume of OZ439 suspension. Subjects will be required to~          fast for a further six hours anytime after dosing with OZ439.~        -  Cohort 3 DSM265 will be administered as a single dose (400 mg) as described for cohort~          1. No additional dose will be administered.~   "
36914|NCT02573844|"~     The purpose of this study is to determine whether Proklama is effective in significative~     reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS~     disease.~   "
36915|NCT02573831|"~     Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental~     or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor~     pain in the early phase. The aim of the randomised, double blinded, placebo controlled study~     was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of~     oxycodone and the effects to the newborn.~   "
36916|NCT02573818|"~     The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms~     during esophagogastroduodenoscopy (EGD) or colonoscopy.~   "
36917|NCT02573805|"~     The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile~     tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.~   "
36918|NCT02573792|"~     Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the~     central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's~     neuromyelitis optica (NMO) or a systemic disease.~      The optical coherence tomography (OCT) is a retinal imaging technique to measure the~     thickness of the retina and its different layers with an accuracy of 4-6 µM.~      Costello et al have shown that approximately 75% of 54 MS patients have developed within 3~     to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal~     nerve fiber layer (RNFL).~      The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed~     by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and~     the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.~      The diagnosis and prognosis value of the OCT in patients with ON is not well known~   "
36919|NCT02573779|"~     A study to compare growth, development of the intestinal bacterial environment, and other~     short term outcomes in groups of babies fed primarily their own mother's milk compared to~     those who receive primarily donor human milk. The investigators hypothesize that infants who~     receive primarily their own mother's milk will have better growth, a more diverse intestinal~     bacterial environment, and possibly some improved short term outcomes such as better feeding~     tolerance and lower rates of infection.~   "
36920|NCT02573766|"~     The goal of this clinical research study is to learn if using a type of non-invasive therapy~     called neurofeedback training can help teach patients with peripheral neuropathy how to~     change their own brain waves to lower their perception of neuropathy and help improve their~     overall quality of life.~      Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a~     computer software program to measure brain wave activity.~   "
36921|NCT02573753|"~     The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic~     reflector of both healthy and disease states, altering in response to changes in the~     environment. This may precede clinically detectable disease; and thereby, could be used to~     predict disease onset and additionally monitor response to treatment and predict prognosis.~     The overall hypothesis of this pilot study is that the human microbial communities are~     influenced by sleep and altered in humans with abnormal sleep patterns, and they may~     ultimately relate to disease risk.~   "
36922|NCT02573740|"~     This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose~     study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive~     Impairment (MCI) due to AD.~   "
36923|NCT02573727|"~     Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin~     Response will assessed at every 48 hour (i) Complete response: Decrease in serum creatinine~     to 133 lmol/L (1.5 mg/dL). (ii) Partial response: 50% serum creatinine decrease from~     baseline to a final value >133 lmol/L (>1.5 mg/dL).~      (iii) No response: Serum creatinine decrease of < 50% from baseline~      Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or~     for a maximum of 7 days after rescue treatment will be followed.~      If intolerant to terlipressin, excluded from study and rescue treatment will be given in~     form of noradrenaline or octreotide and midodrine.~   "
36927|NCT02573675|"~     In this study, the recent trends in outcomes according to the dialysis modality in Korea~     since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or~     high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic~     burden according to the dialysis modality will be investigated retrospectively using the~     Korean Health Insurance Review and Assessment Service (HIRA) database.~   "
36928|NCT02573662|"~     Introduction This study evaluates the effect on glucose, lipid and bone metabolism following~     knee orthopedic procedures in healthy and physically active individuals. The sedentary~     rehabilitation period following these procedures may impact negatively on glucose, lipid and~     bone metabolic pathways, whereas the more physically active rehabilitation period instituted~     6 weeks after surgery is hypothesized to impact positively.~      Perspective This study will establish whether the well-known effects on glucose, lipid and~     bone metabolism of a sedentary lifestyle can be observed already following 6 weeks of~     physical inactivity in otherwise healthy and physically fit young and middle aged~     individuals. Investigators will thereby add knowledge to previous findings following strict~     bed-rest in healthy individuals on glucose, lipid and bone metabolism. In a clinical~     perspective it is important to examine the extent to which healthy individuals deteriorate~     in various metabolic pathways to better understand the pathophysiology behind these defects~     both in healthy individuals and in patients, who undergo bed rest or an equal reduction in~     physical activity as part of their rehabilitation.~      Study design 16 physical active non-diabetic individuals of age 18 - 50 years who are~     undergoing knee surgical procedures at the Arthroscopic Center at Amager/Hvidovre Hospitals~     are recruited as cases for this case-control study.~      10 non-diabetic control subjects matched for age, gender and physical activity are recruited~     to establish a reference level.~        -  The individuals will bring in morning spot urine for measurement of soluble urokinase~          plasminogen activating receptor (suPAR), creatinine, albumin and orosomucoid. Weight~          and height and waist and hip circumference will be measured.~        -  Oral glucose tolerance test (OGTT) with ingestion of 75 g glucose during 5 min from~          baseline (0 min). Plasma for glucose, insulin, C-peptide, non-esterified fatty acid~          (NEFA) will be drawn~        -  Before OGTT blood will be drawn for measurement of HbA1c, total cholesterol, LDL, HDL,~          triglyceride, Na, K, creatinine, hemoglobin (HgB), C-reactive protein (CRP),~          leukocytes, alanintransaminase (ALAT), alkaline phosphatase, Ca++, D vitamin, TSH, bone~          turnover markers (BTM), suPAR, interleukin 6 (IL6), TNFa, high-sensitivity C-reactive~          protein (hsCRP), lipid density profiling and lipid particle size.~        -  Dual energy X-ray absorptiometry (DXA) of hip, lumbar columna, visceral and~          subcutaneous fat is measured by Hologic Discovery scanner.~   "
36929|NCT02573649|"~     Multicentre, prospective, double blinded, randomized study designed as an intrapatient~     comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on~     prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up~     tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory~     vasovagal syncope.~   "
36930|NCT02573636|"~     The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion~     and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist~     after biochemical failure.~   "
36931|NCT02573623|"~     Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific~     symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low~     sensitivity of available diagnostic tools.~      This project aims at evaluating two innovative immunological methods for diagnosing of~     active TB among HIV-infected and uninfected children.~   "
36932|NCT02573610|"~     The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to~     that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for~     perioperative bacteria eradication in patients who are scheduled for cataract surgery.~   "
36933|NCT02573597|"~     Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine~     the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous~     Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential~     PIEB efficacy advantage.~   "
36934|NCT02573584|"~     The vascular fingerprint is a simple selection tool to identify testicular cancer patients~     with a high risk of arterial cardiovascular events during and in the first year after~     cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized~     intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety~     in lowering the chance of an arterial cardiovascular event.~   "
36935|NCT02573571|"~     To develop a score that can predict early from diagnosis of Clostridium difficile infection~     (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future~     to identify patients will benefit from fidaxomicin treatment.~   "
36936|NCT02573558|"~     Delirium are common after orthopedic surgery in the elderly and are directly associated with~     loss of independence, reduction in the quality of life and increased mortality. The cause of~     postoperative delirium still remains unclear and may be multifactorial. The aim of this~     retrospective study is to examine prevalence of postoperative delirium according to the use~     of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under~     regional anesthesia.~   "
36937|NCT02573545|"~     To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software,~     compared to the current method, when planning and inserting the needle under MRI monitoring~     in the context of liver biopsies enable:~        -  a facilitation of the planning stages of the procedure (route path, marking of the~          entry point and alignment of the MRI cutaways on the planned path), resulting in a~          reduction in the duration of the planning stages,~        -  a facilitation of the real-time modification of MRI cutaways during the procedure,~          resulting in a reduction of the duration of the procedure~   "
36938|NCT02573532|"~     This observational study includes patients undergoing major non-cardiac surgery, and screens~     them for the occurence of perioperative myocardial injuries (PMI). Incidence, patient~     characteristics, pathophysiology, and 1-year outcomes of PMI will be described.~   "
36949|NCT02573389|"~     To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact~     the incidence of a post-operative pancreatic fistula, as defined by postoperative. If~     pre-operative pancreatic stenting appears to reduce the formation of Postoperative~     Pancreatic Fistula (POPF) in this pilot study, this will form the basis of a larger~     randomized trial in the future. The hypothesis is that pre-operative pancreatic duct~     stenting can significantly decrease the rate of development of a post-operative pancreatic~     fistula after distal pancreatectomy.~   "
36981|NCT02572973|"~     The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized~     clinical trial examining the feasibility of completing a larger scale efficacy study of a~     novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth~     with anxiety disorders. The primary objective is to establish the feasibility of a blinded~     randomized controlled trial of ANM for childhood anxiety disorders.~   "
36982|NCT02572960|"~     To investigate possible physiologic interactions between the adrenal- and the parathyroid~     glands in patients with secondary hyperparathyroidism.~   "
36939|NCT02573519|"~     Gastrointestinal (GI) symptoms including vomiting, nausea, abdominal pain, constipation or~     chronic diarrhea affect a large number of patients with diabetes mellitus (DM). Furthermore,~     abnormal GI transit times restrict correct dosing of medication. Two new methods, in~     combination only available at Aarhus University Hospital (AUH), allow examination of human~     whole-gut function with a high degree of detail:~      PET-scans (positron emission tomography scans) of cholinergic signaling in the bowel wall~     The most important nerve fibers stimulating GI peristalsis use acetylcholine as~     neurotransmitter. The novel PET technique, [11C] Donepezil PET/CT (Donepezil PET/CT scan~     based on a carbon isotope), developed at AUH, allows in vivo quantification of cholinergic~     cells within the bowel wall.~      3D-Transit With 3D-Transit electromagnetic capsules are followed during their passage~     through the GI tract. The novel method provides highly detailed information about regional~     and whole-gut passage times and contractility patterns.~      Study protocol 20 healthy subjects and 25 diabetic patients with severe GI symptoms will be~     included.~        1. With [11C]donepezil PET/CT, we aim to describe the degree of cholinergic denervation of~          the intestine in DM patients with GI severe symptoms.~        2. Using 3D-Transit in DM patients before and during intervention with acetyl~          cholinesterase inhibitor we aim to determine how cholinergic denervation of the~          intestine contributes to abnormal GI transit patterns.~        3. Comparing the transit times of DM patients with either vomiting or diarrhea as main~          symptoms, we aim to provide pilot data on phenotypes of diabetic GI dysfunction.~        4. We aim to explore various aspects of pan-enteric dysfunction in DM, including~          prolonged gastric emptying secondary to severe constipation and delayed small~          intestinal transit in patients with symptoms of gastroparesis with or without delayed~          gastric emptying~      Perspectives Detailed information about cholinergic denervation in DM and objective~     classification of the pathophysiology of diabetic GI dysfunction may allow targeted future~     treatment of individual patients.~   "
36940|NCT02573506|"~     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy~     after split irradiation with concurrent chemotherapy in locally advanced none-small cell~     lung cancer patients with bulky tumor.~   "
36941|NCT02573493|"~     In this trial, the objectives are to determine the efficacy and toxicity of induction~     chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm~     2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin,~     and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of~     nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the~     frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in~     this cancer.~   "
36942|NCT02573480|"~     This study is an optimization study to evaluate how a wraparound program for youth who have~     been injured by violence helps to change violence related attitudes and beliefs, change~     individual risk factors for violence and reduce the risk of future injury due to violence.~     Wraparound care involves linking the youth with a support worker who will work with the~     youth to develop positive support networks and help them link with services that address~     risk factors towards future violence.~   "
36943|NCT02573467|"~     This extension study will provide data to further evaluate the efficacy, safety, and~     tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in~     patients with sporadic inclusion body myositis. Patients who complete the core study and~     qualify for this extension study will enter Treatment Period 1, during which they will~     continue on the study drug which they were receiving in the core study (either one of the~     three BYM338 doses or placebo). Treatment Period 1 will continue until the dose of BYM338~     with the best benefit-risk profile is determined and selected. The duration of Treatment~     Period 1 could be up to one year (but estimated to be between 6 and 8 months) and the total~     duration of Treatment Period 1 will depend upon the timing of selection of the dose for~     Treatment Period 2. Once the dose with the best benefit-risk profile is selected, all~     ongoing subjects (including those who have been receiving placebo) will enter Treatment~     Period 2 and will be switched to open-label treatment with BYM338 at the selected dose.~     Treatment Period 2 will continue until BYM338 is approved and commercially available in the~     country of the investigational site.~   "
36944|NCT02573454|"~     The purpose of this study is to determine whether prosocial exercise (exercising for the~     benefit of others) results in greater well-being and physical activity when compared to~     personal exercise (exercising without attempting to benefit others). Participants will be~     randomly assigned to utilize one of two exercise apps for a two week period: Charity Miles,~     which allows users to donate money to charities based on exercise participation, or Nike+~     Running, which is a standard GPS exercise app. Participants will be provided with~     questionnaires at pre- and post-test, at a 4 week-follow-up, and immediately before and~     after each use of the app.~   "
36945|NCT02573441|"~     The study will examine whether school liaison services and home-based parental tutoring can~     help with academic difficulties of paediatric brain tumour survivors who received cranial~     spinal radiation and have returned to school. Forty-five patients will participate in the~     project. All patients will receive psychology liaison services to link resources at the~     hospital with those in the community. Patients will participate in one of two tutoring~     programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone~     calls will be used to support parents using the program. Patients will be tested before,~     immediately after, and six months following each tutoring program to assess growth in~     mathematics and working memory abilities.~   "
36946|NCT02573428|"~     The primary purpose of the present study is to evaluate the diagnostic validity of eye~     tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD~     diagnosis. The secondary purpose was to explore the potential prognostic value of eye~     tracking measures through cross-sectional associations with non-verbal cognitive ability.~      Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research~     supports the ability of eye-tracking based measurements to sensitively discriminate~     individuals with ASD and healthy participants. These investigations have identified that the~     core deficit in autism as disruption of social attention, reflecting an inability to~     appropriately engage and track socially- and emotionally-relevant aspects of the visual~     world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be~     a useful approach to identifying objective markers of ASD. Eye tracking also carries the~     advantages of being less intrusive and expensive than MRI and genetic testing and~     specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in~     social attention.~      After diagnosis of ASD, key clinical tasks in young children involve determining an accurate~     prognosis and tracking the progress of early interventions. Currently, the only prognostic~     indicators are clinical observations (subjective and expensive) and non-verbal cognitive~     ability testing (difficult to acquire, time-consuming, unavailable in many settings).~     Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to~     being an objective marker for ASD, eye tracking measurements have potential to be useful for~     predicting cognitive and functional outcomes. Similarly, the only available methods for~     tracking treatment progress are parental reports (highly subjective), clinical observations~     (subjective and expensive), and cognitive measurements (expensive and unavailable in many~     settings. This study will evaluate, using cross-section data, the potential for eye tracking~     data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis~     for ASD-affected children. Additionally, this study will evaluate the test re-test~     reliability of eye tracking parameters that can potentially be used to track treatment~     progress.~   "
36947|NCT02573415|"~     This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine~     transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with~     uterine factor infertility will need to be screened to identify 10 appropriate subjects.~      There are seven phases involved in this study: Primary and Secondary Screening, Medical~     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up~   "
36950|NCT02573376|"~     Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users,~     yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent~     and therefore denied potentially life-saving therapy. This assumption can only be confirmed~     or dispelled through prospective pharmacologic and adherence studies in this population.~     Such studies would be greatly enhanced by an objective, quantitative measure of adherence~     which does not currently exist in the HCV field. Through the work proposed in this~     application, sixty HIV/HCV co-infected drug users will be treated with direct acting~     antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no~     directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly~     observed therapy (WOT) which involves use of a portable medication dispenser that sends a~     signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA~     concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics~     will also be defined accounting for clinical factors like degree of hepatic impairment and~     use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence~     in this population and the effect of variable adherence on drug concentrations. In Aim 2,~     DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns~     identified using WOT and DOT. The goal is to identify a drug concentration biomarker that~     predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as~     measured by WOT and DOT and drug concentrations) and rate of cure will be established. The~     goal is to define the degree of adherence needed for HCV cure.~   "
36951|NCT02573363|"~     This phase I trial studies the side effects and the best dose of selinexor when give~     together with standard chemotherapy, high dose cytarabine and mitoxantrone hydrochloride, in~     treating patients with acute myeloid leukemia. Selinexor may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving selinexor together with standard chemotherapy may be a better~     treatment for patients with acute myeloid leukemia.~   "
36952|NCT02573350|"~     A phase 2, multicenter, uncontrolled, open-label trial in patients with MDR-TB. Only~     patients who completed Trial 204 were eligible. The trial was performed globally at 14 sites~     qualified to treat MDR-TB. All 434 patients who completed Trial 204 were eligible for this~     trial if there was still potential clinical benefit to them and all inclusion criteria and~     no exclusion criteria were met.~   "
36953|NCT02573337|"~     The purpose of this study is to evaluate the perception of facial expressions following~     correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and~     Emervel Deep Lidocaine.~   "
36954|NCT02573324|"~     This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy~     and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in~     participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor~     (EGFR) amplification.~      In addition, this is a Phase 1, open-label, multicenter sub-study to assess the~     pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed~     EGFR-amplified GBM who have mild or moderate hepatic impairment.~   "
36955|NCT02573311|"~     An actual use study to assess how men who respond to advertisements about urinary symptoms~     use tamsulosin in a simulated Over the Counter (OTC) setting including following stop use~     and ask a doctor if and ask a doctor before use statements and if they take the~     medication according to the label instructions, also assess any reported adverse events~     during simulated OTC use.~   "
36956|NCT02573298|"~     The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or~     cold gas) applications on arthritic knees.~      Evaluation criteria (before/after treatment):~        -  synovial power-Doppler semi-quantitative score~        -  pain VAS (mm)~        -  cytokine levels in synovial fluid~        -  leukocyte count in synovial fluid~   "
36957|NCT02573285|"~     The objective of this multi-center, non-randomized, prospective pilot study is to examine~     the rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple~     aspiration technique.~      In this study, eligible subjects diagnosed with PSP at eleven participating large children's~     hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be~     enrolled and offered a choice of management with either the simple aspiration protocol or~     management according to their surgeon's preference, which may include simple aspiration,~     chest tube placement, or rarely, an operation.~   "
36958|NCT02573272|"~     Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on~     cardiovascular risk factors measured by biochemical and ultrasound parameters compared with~     enzyme-inducing AEDs.~   "
36959|NCT02573259|"~     Protocol B8011001 is a Phase 1, open-label, multi center, multiple-dose, dose escalation,~     safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 administered~     intravenously/subcutaneous in previously treated adult patients with locally advanced or~     metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, or relapsed or refractory cHL or~     other solid tumors. This 2 Part study will assess the safety and tolerability of increasing~     dose levels of intravenous (IV)/subcutaneous (SC) PF-06801591 and in Part 2 will establish~     the recommended Phase 2 dose (RP2D).~   "
36970|NCT02573116|"~     Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in~     patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP.~     Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2~     (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral~     Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3~     (20 weeks) after periodontitis treatment for the group of patients with chronic~     periodontitis.~   "
36971|NCT02573103|"~     To determine the effect of ambient PM2.5 exposures at low levels in Southeastern Michigan~     and high levels in beijing on lipid metabolism among healthy adults without CV disease.~   "
36997|NCT02572765|"~     The purpose of this study is to evaluate the splenic activation in hypertensive patients, as~     compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will~     investigate whether the splenic metabolic activity relates to the expression of circulating~     inflammatory proteins (high-sensitivity C-reactive protein [hsCRP]), interleukin-1b (IL-1b),~     tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.~   "
36960|NCT02573246|"~     Psychological treatments are effective, but take a long time and can be burdensome.~     Therefore, avenues to optimize behavioral treatments are needed. Despite important~     advancements, neuroscience has had a limited effect on psychotherapy development. Therefore,~     one paradigm shift would be to develop neuroscience informed behavioral treatments.~      The investigators identified from the literature a problem that affects several mental~     disorders (emotion dysregulation) and a neural circuit that underlies this important~     concern. They found that this circuit is dysfunctional in those with psychopathology but can~     be changed with treatment. The goal is in one session to train this brain network to operate~     more efficiently and to test the short and long term effects of this intervention. The~     investigators plan to engage this brain network using a traditional psychotherapy strategy~     (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic~     stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances~     the electrical activity in brain areas close to the scalp.~      The study team proposes to include 65 participants divided into 3 groups. All participants~     will be trained in emotion regulation by first being asked to remember an event where they~     experienced a negative emotion and then being instructed either to think differently about~     the event, or to wait. Participants will simultaneously undergo either real (left or right~     side of brain) or sham rTMS. The investigators will measure their regulation in the lab and~     during a-week long naturalistic assessment. Participants will return to rate feasibility,~     acceptability, and to provide feedback. If successful, this proof of concept study can open~     new frontiers for neuroscience informed treatment development.~   "
36961|NCT02573233|"~     Primary Objective:~      To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients~     with persistent asthma.~      Secondary Objective:~      To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.~   "
36962|NCT02573220|"~     This phase I trial studies the side effects and the best dose of irinotecan hydrochloride,~     based on a genetic test, when given in combination with fluorouracil, leucovorin calcium,~     and cetuximab as first-line therapy in treating patients with an abnormal gene called RAS~     wild-type that has spread to other parts of the body (metastatic). Patients may also have a~     gene called uridine diphosphate glucuronosyltransferase (UGT1A1) that may interfere with the~     way irinotecan hydrochloride is absorbed by the body and may not be able to tolerate it.~     Determining the presence of this gene may help determine the best dose of irinotecan~     hydrochloride when given with fluorouracil and leucovorin calcium (FOLFIRI). Combination~     chemotherapy, such as FOLFIRI, works in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Cetuximab may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving FOLFIRI together with cetuximab may be a better treatment for~     patients with colorectal cancer.~   "
36963|NCT02573207|"~     This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in~     a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular~     assist device (LVAD) implantation to investigate the incidence of recovery of myocardial~     function when supported with LVADs, and to study the association between hibernating~     myocardium and myocardial recovery in this population.~   "
36964|NCT02573194|"~     Over the last decades, changes in the diet and lifestyle have led to overall energy~     imbalance becoming commonplace and the emergence of an obesity epidemic with more than 1.6~     billion adults being overweight.~      Consumption of foods that can affect appetite by increasing satiety could regulate the total~     energy intake and thus body weight. There is data suggesting that the macronutrient~     composition of the foods and especially protein content may have a potent role on satiety.~     However, the type of protein appears to play a role in satiety possibly due to the different~     balance of the amino acid profile.~      The research project is dedicated to identify the source (animal or plant) and the optimized~     protein quantity needed to accelerate satiation, suppress appetite and extend satiety until~     hunger appears again.~      It is hypothesized that the consumption of animal derived protein-enriched meals will induce~     a reduction in hunger through the impact on gut hormones and peptides that are closely~     related to the short-term regulation of food intake.~   "
36965|NCT02573181|"~     This study is designed to assess the safety, tolerability, and immunogenicity of V114~     compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated~     with 23-valent pneumococcal polysaccharide vaccine.~   "
36966|NCT02573168|"~     Evidence exists supporting the ability of genetic variations to influence patient drug~     response and side effects. To-date, no RCT has been conducted to evaluate the outcomes in~     schizophrenia/schizoaffective disorder patients following the use of pharmacogenomic~     guidance of treatment selections. The first objective of this trial is to utilize a~     double-blinded, randomized clinical trial design to evaluate the clinical outcomes in~     participants treated with the benefit of GeneSight Psychotropic (GEN) test. Another~     objective is to determine the added benefit of Enhanced-GeneSight (E-GEN) compared to GEN~     for the pharmacogenomic guidance of treatment selections. Furthermore, this trial intends to~     develop an evidence-based case for the value of GEN and E-GEN to Canadian healthcare payers.~   "
36967|NCT02573155|"~     This is a phase I, randomised, placebo-controlled 2-part study to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in~     asthmatic and chronic obstructive pulmonary disease (COPD) subjects.~   "
36968|NCT02573142|"~     The primary aim of this study is to reduce body mass index (BMI) among children ages 5-11~     who are obese by integrating behavioral treatment strategies in both clinic (Healthy~     Lifestyles) and community (Bull City Fit) settings. A two-group randomized, controlled,~     non-blinded pilot design will be utilized. The intended target population is the adult~     caregiver and a child with obesity (BMI ≥ 95th percentile) aged 5-11. The intervention~     condition will be standard care with Healthy Lifestyles programming plus Bull City Fit;~     upcoming activities will be texted to the parents mobile device using GoogleVoice. The~     control condition will be standard clinical care with Healthy Lifestyles programming.~     Primary outcome is BMI at 6 months. Secondary outcomes include anthropometric, psychosocial,~     and reported health behaviors.~   "
36969|NCT02573129|"~     The purpose of the proposed research study is to assess the effects of including greater~     amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on~     cardiometabolic and emotional well-being.~   "
36972|NCT02573090|"~     The research project SEAL-DK is focusing on advantages and disadvantages of two treatment~     strategies: non-invasive fissure sealing and invasive restorative treatment of manifest~     occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the~     project is to promote the understanding of the possibilities of non-invasive treatment of~     occlusal caries lesions in the permanent dentition, and to increase the present knowledge~     about the optimal threshold for sealing or restoration, respectively, when treating such~     lesions.~      The project is carried out as a randomized study of the two treatment strategies:~     non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is~     emphasized that no treatment shall be carried out, if conflicting the participating~     dentists' perception of clinically proper caries treatment, and that the results shall have~     a high reliability and consistency.~      The hypothesis is that caries progression can be stopped by non-invasive fissure sealing~     changing the threshold and postponing the time for invasive restoration.~   "
36973|NCT02573077|"~     This observational, prospective, non-interventional study will include cancer patients who~     need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed~     treatment(s) according with the clinical practice regardless of the patient participation in~     the study. The purpose of this NIS is to collect additional scientific and clinical~     information that can help in describing the characteristics of cancer patients with~     hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to~     keep under control serum [Na+] and the guidelines for the management of this population in~     Italy.~   "
36974|NCT02573064|"~     The present study was designed to study the impact of empirical treatment with colistin~     empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of~     bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the~     efficacy of empirical treatment with colistin and combined targeted therapy. The different~     therapeutical interventions were administered following the routine clinical practice in the~     medical centre and the investigator did not assign specific interventions to the subjects of~     the study.~   "
36975|NCT02573051|"~     Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy~     Association estimates that blighted ovum causes approximately 50 percent of all~     first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.~      In general, there are 3 options for management of anembryonic pregnancy: expectant, medical,~     and surgical management. Expectant management consists of no intervention and awaiting~     natural passage of tissue. Medical management uses medication to expel uterine tissue.~     Surgical management is defined by mechanical removal of tissue from the uterus.~      Medical management allows patients to avoid surgery and anesthesia. Patients may also feel~     that medical management is more private, and under their control. Several medications have~     been studied for medical management.~      Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening~     and contractions that expel the products of conception. It may be administered vaginally,~     orally, buccally, or sublingually. Adverse effects vary based on route of administration.~      There is published literature on a wide range of therapeutic misoprostol regimens. Optimal~     dose and route of administration of misoprostol have not been determined by randomized~     trials. Overall, misoprostol is safe and well-tolerated.~      Patients receiving misoprostol vaginally rather than orally have decreased adverse~     gastrointestinal effects and prolonged duration of action.~      Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus.~     Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine~     emptying but is associated with more frequent diarrhea.~      When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at~     completing uterine emptying, although it results in a similar incidence of nausea. Based on~     international trials in settings with limited resources, WHO recommends a single vaginal~     dose of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of~     misoprostol administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is~     associated with a greater overall exposure to the drug and greater effects on the cervix and~     uterus.~      Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris,~     which acts by dilating the blood vessels so as to reduce blood pressure.~   "
36976|NCT02573038|"~     Angioid streaks are rare lesions associated to retinal pigment epithelium degenerations.~      They can be caused by general diseases as pseudoxanthoma elasticum, Paget's disease or~     drepanocytosis. Choroidal neovascularization (CNV) represents the most frequent complication~     for those patients. It leads to a rapid and important loss of visual acuity. CNV in angioid~     streaks represent the fourth leading cause of CNV in young patients.~      CNV in angioid streaks is treated at the moment with off-label anti-VEGF (Vascular~     Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new~     anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need~     as many injections as in AMD.~      ASTRID is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by CNV in angioid streaks. A~     specific dosage regimen is designed to achieve maximum efficiency. The patients are followed~     on a monthly basis until 52 weeks. Six injections are mandatory, the other ones are injected~     only in case of active CNV.~   "
36977|NCT02573025|"~     This is an open-label, randomized, multi-center, single dose, two-period, two-sequence~     crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation~     versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous~     administration via prefilled syringe in healthy Chinese participants.~   "
36978|NCT02573012|"~     This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group,~     international, multicenter trial compares the change in disease activity (as assessed by~     Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from~     randomization to Week 24 post-randomization, in participants with stable low disease~     activity [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and~     have been randomized to either continue or taper prednisone in a double-blinded fashion.~   "
36979|NCT02572999|"~     This prospective cohort study aims to determine the incidence of hospitalization-associated~     disability and its association with risk factors at the patient level and with care and~     hospital processes. For this, patients aged 70 years or older admitted for elective valve~     surgery or elective transcatheter aortic valve implantation or as a result of symptomatic~     moderate to severe valvular heart disease will be consecutively included from 01 October~     2015 to 29 February 2016.~   "
36980|NCT02572986|"~     Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis~     of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and~     distribution of the rash. Definitive diagnosis includes the microscopic identification of~     the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the~     drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for~     use in adults and children 2 months and older.~      This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to~     Elimite® in the Treatment of Scabies.~   "
36983|NCT02572947|"~     Current HIV treatment guidelines recommend a combination of drugs for the maintenance of~     antiretroviral therapy (ART). Simplification is considered critical to further scale-up of~     treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily~     integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance~     profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in~     maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months~     on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase~     inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary~     endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without~     experiencing virological failure.~   "
36984|NCT02572934|"~     Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy,~     alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival~     rates are above 90% nowadays, which results in growing TC survivor population. Because of~     the long life expectancy of these survivors, prevention or early detection of late treatment~     effects has become increasingly relevant. Yet known late effects are nephrotoxicity,~     cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary~     toxicity, Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems.~     Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors~     since performed studies have a follow-up duration of 5-14 years. Decreased renal function is~     a known risk factor for CVD development and also an association between renal function and~     neurtoxicity via circulating platinum levels has been shown. It is hypothesized that~     treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for~     development of late effects. The secondary aim is to assess prevalence of late effects in~     very long-term TC survivors: until now, most data have been collected through questionnaires~     in large epidemiological studies in TC survivors till approximately 10 years after~     treatment. The prevalence of late effects may increase over time: 10 years after treatment~     late effects may not be present yet, whilst late effects can emerge just after 20 years.~     Consequently, health status and possible late effects, resulting in morbidity, are~     underestimated in patients who are 20-30 years after treatment. By investigating health~     status of these very long-term survivors a more profound insight in the prevalence and~     aetiology of these late effects and the development over time can be assessed. Current~     treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late~     effects is relevant for currently treated patients. Furthermore, as a result of this study,~     we will better understand which factors and issues should be watched closely during~     follow-up, which TC survivors are at increased risk of developing late treatment effects and~     how to detect early damage before overt morbidity occurs.~   "
36985|NCT02572921|"~     This study evaluates the effects of the Positive Psychotherapy on depressive symptoms and on~     happiness compared with regular cognitive behavioral therapy.~   "
36986|NCT02572908|"~     This is randomized pilot study comparing tolerability of yeast-baked wheat bread and~     sourdough wheat bread in irritable bowel syndrome.~   "
36987|NCT02572895|"~     The purpose of this clinical trial study is to assess, among young and sexually active women~     presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of~     cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs),~     compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of~     new UTIs during a 6-month follow-up period.~   "
36988|NCT02572882|"~     The Microbiome trial is a non-randomized, open-label, crossover, multi-center study of~     p-inulin for patients with hemodialysis-dependent end-stage renal disease.~   "
36989|NCT02572869|"~     The purpose of this study is to assess the functional and esthetic outcomes in patients who~     had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the~     jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.~   "
36990|NCT02572856|"~     During surgery and after surgery elevated blood glucose levels can lead to poor outcome such~     as wound infections. Current technology does not allow close monitoring of glucose levels~     often resulting in poor management of glucose levels. In this study, the investigators will~     evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 4 Professional)~     during and after surgery. Such a monitor has the potential of monitoring glucose levels~     continuously and in real-time, thus allowing better glucose management~   "
36991|NCT02572843|"~     The objective of the trial is to demonstrate that the addition of neoadjuvant and adjuvant~     immunotherapy (with the anti-PD-L1 antibody MEDI4736) to standard neoadjuvant chemotherapy~     (with cisplatin/docetaxel) in primary resectable stage IIIA(N2) NSCLC is efficacious and~     feasible.~   "
36992|NCT02572830|"~     Blocking of reconsolidation by pharmacological or behavioral means offers the therapeutic~     possibility of weakening traumatic memories in posttraumatic stress disorder (PTSD). Two~     reconsolidation-based interventions, propranolol and extinction learning, have been shown to~     weaken fear memories in human healthy subjects. However, the success of these interventions~     seems to be limited to weak conditioned fear memories. This calls for new, potentially more~     efficacious, interventions to be tested. Bilateral eye movements seem to be a promising~     candidate intervention for blocking reconsolidation due to the compelling evidence of Eye~     Movement Desensitization and Reprocessing as effective treatment in PTSD. The investigators'~     aim is to test bilateral eye movements as an active reconsolidation-blocking intervention in~     an optimized differential fear conditioning procedure that the investigators have recently~     developed. This novel experimental assay creates stronger fear memories in healthy~     individuals.~   "
36993|NCT02572817|"~     This study will assess the efficacy and safety of anti-influenza immune plasma, as an~     addition to standard of care antivirals, in participants hospitalized with severe influenza~     A infection.~   "
36994|NCT02572804|"~     This is a prospective randomised controlled trial that will compare the outcomes of rectus~     sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower~     midline abdominal incision for bladder cancer.~   "
36995|NCT02572791|"~     The investigators propose a pragmatic comparative effectiveness trial evaluating several~     decolonization strategies in patients with Staphylococcus aureus infection, their household~     contacts, and household environmental surfaces. The central hypothesis of this proposal is~     that an integrated approach of periodic personal and household environmental hygiene will~     reduce S. aureus transmission in households and subsequently decrease the incidence of skin~     and soft tissue infections (SSTI).~   "
36996|NCT02572778|"~     The investigators want to have a collection of fresh primary or recurrent tumor tissue for~     establishment of patients-derived xenografts in order to:~      generate a biobank of in vivo patient xenografts representing the different subgroups of~     tumors for head and neck cancer~        -  perform genetic and transcriptional profiling of the primary, metastatic tumors and~          xenograft tumors~        -  evaluate the efficacy of new targeted agents, whether or not in combination with~          standard treatment options~        -  evaluate biomarkers of drug sensitivity~        -  study primary and secondary (acquired) resistance in these models~   "
36999|NCT02572739|"~     Thermodilution cardiac output measurement is a reliable method, but it is an invasive one.~     PiCCO device requires cannulation of central vein and peripheral artery. Impedance method~     requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim~     of study is to assess accuracy and reliability of impedance method ( using NICCOMO device)~     in comparison of thermodilution method ( using PiCCO device) at different PEEP levels.~   "
37000|NCT02572726|"~     Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical~     functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism~     is unknown. The proposed research will use TMS in conjunction with brain imaging and~     electrophysiology to examine cortical plasticity and connectivity modifications induced by~     repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous~     analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia)~     states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and~     followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion~     Tensor Imaging (DTI). This will be done in order to examine alterations of cortical and~     brainstem mechanisms involved in EA and to investigate connectivity changes between cortical~     and sub-cortical regions of the EA networks. The latter as well as EA efficiency and~     pain-related personality variables will be used to assess individual differences in~     neuroplasticity within the EA systems in both healthy subjects and chronic pain patients.~   "
37001|NCT02572713|"~     The purpose of this study is to measure alpha-synuclein in peripheral body tissues and~     fluids in Parkinson's disease (PD). This may help in developing better treatments for PD~     patients in the future.~   "
37002|NCT02572700|"~     The objective of the study is to investigate pain mechanisms, ultrasonographic (US)~     inflammatory activity and association between these conditions in patients with psoriatic~     arthritis (PsA) intensifying anti-rheumatic treatment. Further, to assess the predictive~     value of baseline pain profile and US joint/entheses activity on treatment outcome after 4~     months.~   "
37003|NCT02572687|"~     The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in~     participants with locally advanced and unresectable or metastatic gastrointestinal or~     thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma,~     non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).~   "
37004|NCT02572674|"~     Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal~     objective of this research is to test the predictive value of core vulnerability dimensions~     such as affective instability and emotional reactivity, measured by validated questionnaires~     (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic)~     during a 24 months prospective follow-up.~      In addition, several arguments suggest that inter-individual variability in the risk of~     relapse is influenced by genetic factors. In particular, the implication of such factors~     have been demonstrated in rapid cycling or antidepressants induced mania. However, this has~     never been tested in cohorts followed prospectively. Finally, the existence of~     neuropsychological deficits in bipolar disorder is well documented and their role in the~     risk of relapse is suspected. Yet the nature of these deficits, their origin and~     evolutionary course remain poorly investigated. In summary, the secondary objectives of this~     research are the study of the influence of these other clinical, neuropsychological and~     genetic factors on the risk of relapse.~      • Scientific rationale The dimensions of affective instability and emotional reactivity, are~     considered core psychological and temperamental vulnerability dimensions to bipolar~     disorder. Differences in levels of instability and reactivity may account for the~     inter-individual variability observed in bipolar disorder in terms of risk of relapse. These~     dimensions are measured using validated questionnaires (Affective Instability Measure (AIM)~     and Affective Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive~     episode, hypomanic, manic or mixed episode (DSMIV criteria).~      Other factors that may influence the risk of relapse have been suggested in the literature~     but have not been formally tested in prospective studies:~        1. cognitive deficits: the existence of neuropsychological deficits in bipolar disorder~          are well documented and their role in the risk of relapse is suspected. Yet the nature~          of these deficits, their origin and their course remain poorly investigated. Indeed,~          some appear to be related to the neurotoxicity of the episodes themselves, the other~          being related to the vulnerability to bipolar disorder~        2. The involvement of genetic vulnerability factors in bipolar disorder is widely~          demonstrated. Several arguments suggest the implication of genetic factors in the risk~          of relapse. This is the case for some outcome patterns such as rapid cycling or~          antidepressants induced mania. Again, this has never been tested in cohorts followed~          prospectively.~        3. The role of certain inflammatory and infectious factors in the etiology of bipolar~          disorder has been suggested but it is clear whether these biomarkers are state or~          traits. Thus, the role of neurotoxic inflammatory or infectious factors in relapse~          mood has never been tested in a prospective follow up studies.~             -  Main objective of the project To determine if the scores of AIM and ALS, assessed~               at baseline in euthymic bipolar patients is associated with relapse in patients~               during a 2 years follow-up period.~             -  Secondary objectives of the project Determine if the neuropsychological~               performance at T0, measured in euthymic patients predict relapse during a 2 years~               follow-up period.~      Determine whether the neuropsychological deficits observed in euthymic bipolar patients that~     contribute to functional impairment worsen with time.~      DNA collection to test the involvement of candidate genes Serum collection to study the~     biological and infectious biomarkers~      • Methodology Prospective follow up studies. Multicenter.~   "
37005|NCT02572661|"~     This study aims to explore the feasibility, safety and outcome of a non‐invasive sentinel~     node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the~     ipsilateral neck only and to exclude the contralateral negative neck from the irradiation~     fields when there is no draining sentinel node. Subsequently the dose to the salivary~     glands, mucosal area and the swallowing and chewing muscles and structures involved in~     voicing and articulation will significantly be reduced~   "
37006|NCT02572648|"~     The purpose of this study is to examine the relation between the structural brain changes~     associated with heart failure, neurocognitive performance, and how these changes impact~     self-care behaviors.~   "
37007|NCT02572635|"~     Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears,~     sinuses or lungs. It can also cause more serious infections of the blood or brain. The~     elderly and young children are more vulnerable to these types of infections.~      The vaccines available at present are effective only on a certain number of strains of the~     bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains.~     This study will be looking at the safety and tolerability of the study drug for three~     different dosages: 50 μg, 200 μg, and 500 μg compared to placebo.~      The population eligible to take part in the study are healthy male and female subjects~     between 18 and 40 years of age.~      Volunteers for the study will be recruited through advertisements. Each volunteer will have~     received an information sheet concerning the study and will have agreed to participate in~     writing. Volunteers will be given at least 48 hours between reading the information leaflet~     and agreeing to participate. Only subjects who agree to undertake precautions to avoid~     pregnancy of either themselves of their partner during the study period will be eligible.~     Volunteers will give signed consent for their physician to be notified about their~     participation in the trial.~   "
37018|NCT02572492|"~     This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone~     before salvage high-dose melphalan with autologous stem cell support (HDT) in multiple~     myeloma patients with relapse after HDT done at diagnosis. In addition, the study evaluates~     the effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT~     half of the patients receive maintenance therapy with carfilzomib/dexamethasone while the~     other half are observed without maintenance therapy.~   "
37019|NCT02572479|"~     The proposed observational trial will collect substantial data concerning dietary intake~     documented by ALS patients complemented by the analysis of fatty acid distribution in~     erythrocyte lipids. Both data sets are related to disease status and progress.~   "
37008|NCT02572622|"~     The aim of this study is to determine the effectiveness of three different treatment methods~     which consists spinal decompression, deep friction massage and exercise. The patients were~     separated three groups Group one received non-surgical spinal decompression therapy, group~     two received non-surgical spinal decompression, lumbar stabilization exercises and manual~     therapy, group three received manual therapy and lumbar stabilization exercises. All groups~     completed 15 sessions of therapy. In each session, pain severity was assessed with numeric~     analog scale, straight leg raise test applied and the degree of the hip flexion where the~     patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance~     tests were applied before the treatment sessions started, after the treatment sessions~     ended, six weeks after and three months after the study. Oswestry Disability Scale (ODI),~     Back Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs~     Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment~     sessions started, after the treatment sessions ended and three months after the study.~     Gradient of disc height and thickness of the herniation were assessed segmentally with~     magnetic resonance imagination (MRI) before the study and three months after the study.~   "
37009|NCT02572609|"~     to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation),~     manufactured by Bolder Arzneimittel GmbH & Co. KG to Boehringer Ingelheim compared to~     ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim~     do Brasil Química e Farmacêutica Ltda.~   "
37010|NCT02572596|"~     Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood~     stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO~     combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell~     mobilization.~   "
37011|NCT02572583|"~     This prospective randomized controlled trial studies the efficacy and safety of treating~     influenza with the reconciling exterior and interior therapy. A total of 300 cases of~     seasonal flu in Beijing is to be collected, and divided into one treatment group and two~     control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while~     patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate~     Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of~     treating influenza with the reconciling therapy based on the following outcome measures: the~     time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it~     takes for the body temperature to return to normal.~   "
37012|NCT02572570|"~     Polymerization shrinkage remains one of the primary disadvantages of composite resin~     restorative materials (tooth-colored fillings). To minimize the effects of polymerization~     shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin~     called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and~     properties allow the material to be inserted in one single increment, expediting treatment.~     This clinical trial is designed to evaluate the performance of the new bulk fill composite~     resin in Class II (two-surface posterior) fillings.~   "
37013|NCT02572557|"~     Rationale: Spray cryotherapy (SCT) using liquid nitrogen has been safely and effectively~     used in the esophagus, airways and pleura. Treatment with SCT for central airway stenosis~     may provide an effective, and more durable and perhaps safer alternative to the current~     therapeutic modalities.~      Objectives:~        1. To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~        2. To investigate the safety of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~        3. To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~      Study design: This study will be a prospective, single arm, open label intervention study~     performed at the University Medical Center Groningen, The Netherlands Study population: The~     study population exists of 25 patients with malignant or benign central airway disease.~     Patients in which current treatment options are regarded to be suboptimal can be included in~     the study.~      Intervention: TruFreeze Spray CryoTherapy~      Main study parameter:~      Feasibility is defined as being able to apply the SCT as planned in one, or more~     bronchoscopies according to the instructions for use (IFU).~      Secondary study parameters:~      Safety will be assessed by capturing all adverse events (AEs) that occur 1) during the SCT~     procedure, and 2) all AEs that occur until hospital discharge.~      Efficacy will be measured using 1) patient reported outcomes (questionnaires), 2) percentage~     improvement in airway stenosis, 3) durability of treatment effect, 4) need to re-intervene~     with other therapies because of treatment failure.~      Nature and extent of the burden, risks and benefit associated with participation.~      Patients that will be recruited and participate in this prospective clinical trial have a~     severe central airway disease which is highly symptomatic for which current available~     therapies are either very difficult to perform, are hazardous, have no real benefit, or just~     simply not available yet. The current treatment risks of this patient group are high,~     especially in the patients where the airway patency is at risk. The main additional risk~     associated with the use of SCT is the occurrence of a pneumothorax. Patients participating~     will adhere to their current medical care, with the one addition of a voluntary follow-up~     bronchoscopy after SCT.~   "
37014|NCT02572544|"~     Purpose of this study is to compare the ocular functional changes including pupil size,~     visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity,~     and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading~     speed and survey for ocular discomfort after using both pinhole glasses.~   "
37015|NCT02572531|"~     The aim of this research is to study the effect of probiotic supplements (Lactobacillus~     reuteri) on post-surgical complications and oral wound healing after extraction of impacted~     third molars.~   "
37016|NCT02572518|"~     To evaluate the immune status of yellow fever in adults with a history of two or more doses~     of vaccine, having received the second dose for at least 1 year, compared to re-vaccinated~     individuals (second dose) after 30 days.~   "
37017|NCT02572505|"~     Human immunodeficiency virus (HIV) infection has now become a treatable disease and many~     infected individuals are interested in having a family. Couples in which the man is infected~     but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical~     intervention during procreation to prevent HIV transmission to the female and her child. The~     current view is that reducing the number of infections involving unprotected intercourse in~     HIV-discordant couples is a public health issue in the U.S. The safest methods for~     HIV-discordant couples are insemination using a sperm donor, adoption and remaining~     childless. However, some couples strongly desire a biologically related child. Fertility~     clinics in the United States have been resistant to treating HIV-discordant couples,~     offering only expensive, invasive techniques. This reduces access to care, leading to~     couples choosing unprotected intercourse to conceive a child. Pre-exposure prophylaxis~     (PrEP) is a treatment taken by the woman before having unprotected intercourse with an~     infected man. Truvada has been approved by the Food and Drug Administration (FDA) to reduce~     the risk of HIV-discordant couples and the Centers for Disease Control and prevention (CDC)~     has recommended that serodiscordant patients who wish to have a child be counseled on the~     availability of PrEP. When risks of transmission are minimized, including undetectable HIV~     in blood and use of PrEP, unprotected intercourse during the fertile period is likely to be~     a safe option for conceiving a child. The investigators propose to enroll HIV-discordant~     couples who have been counseled on the safer alternatives of donor insemination, adoption~     and remaining childless; have been offered referral to a clinic offering sperm washing with~     insemination or in vitro fertilization (IVF); have been apprised of the risks of using PrEP~     and one timed intercourse per cycle; and decide to proceed with this method. Couples will be~     from the population of HIV-discordant patients with a minimal risk of disease transmission~     as described above. After evaluation for normal fertility and low potential for disease~     transmission, the couple will receive instruction on timing of the most fertile day of the~     cycle, and the woman will be given a prescription for the PrEP medication. The woman and any~     offspring will be followed for 6 months using blood tests to check for evidence of HIV~     infection.~   "
37020|NCT02572466|"~     This study objective is to compare the high sensitive troponin-I level in end-stage renal~     disease patients received hemodialysis without acute cardiovascular event with healthy~     population. The investigators also determine the effect of hemodialysis on troponin I level~     as the secondary objective.~   "
37021|NCT02572453|"~     This phase II trial studies how well AT13387 works in treating patients with anaplastic~     large cell lymphoma, mantle cell lymphoma, or diffuse large B-cell lymphoma that has not~     responded to previous treatment or that has returned after a period of improvement. AT13387~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
37022|NCT02572440|"~     Perioperative blood loss continues to be a serious problem in complex aortic arch surgery~     using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased~     morbidity and mortality [1]. These patients often require transfusion of allogeneic blood~     products. It has been estimated shortages of blood supply in China will worsen [2].~     Clinicians have made significant progress to decrease the quality of allogenic blood~     transfusion.~      Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be~     related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to~     coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential~     benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a~     promising approach because it avoids CPB-related platelet damage and limits post-CPB blood~     loss. So we adopted and used aPRP as a blood conservation technique to reduce blood~     transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to~     maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were~     transfused after heparin neutralizing activity as no active bleeding was observed. Our goal~     was to determine the effect between aPRP and homologous transfusion on perioperative~     bleeding during complex aortic arch surgery using DHCA.~   "
37023|NCT02572427|"~     The overall goal of this study was to create a simulation environment with repeated practice~     for residents and intense, immediate feedback. Repeated simulations for neonatal~     resuscitation when coupled with clinical experience have been shown to improve resident~     confidence.The investigators sought to determine if resident exposure to individual training~     and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and~     decrease intubation times in a neonatal manikin. The primary outcome was time to intubation~     after one year. The secondary outcome was the ability to retain cognitive instruction~     related to intubation~   "
37024|NCT02572414|"~     African American men infected with HIV are living longer and are acquiring the same chronic~     non-communicable diseases affecting the general population of African American men age 40~     years and older. African American men have disproportionately high rates of cardiovascular~     disease, hypertension, diabetes, kidney disease, and cancer, particularly prostate and colon~     cancer, but HIV is associated with an increased risk for co-morbidity from these conditions,~     a risk heightened by not only HIV infection itself, but also its treatment with~     antiretroviral therapy (ART). The risk for many of these chronic diseases is tied to~     behavior: risk is increased by physical inactivity and unhealthful diet. Although the high~     risk for behavior-linked chronic diseases among HIV-positive individuals has been~     recognized, there is a lack of evidence-based interventions specifically tailored to their~     needs.~      Hence, the broad objective of this research is to identify strategies to empower HIV~     positive African American men to engage in behaviors that reduce their risk of chronic~     diseases. This research will test the efficacy of a theory-based, contextually appropriate~     health promotion intervention in inducing positive changes in behaviors linked to risk of~     chronic diseases among HIV positive African American men age 40 years or older and will~     identify the theoretical variables that mediate its efficacy.~      In a randomized controlled trial, African American HIV positive men age 40 or older who are~     receiving ART for HIV will be randomized to the Men Together Making a Difference Health~     Promotion Intervention, which consists of three, 3-hour weekly intervention sessions, or the~     1 session Health Awareness Control Group. The Men Together Making a Difference Health~     Promotion Intervention is based on social cognitive theory and the reasoned action approach~     integrated with formative research. Data will be collected at baseline, immediately post,~     and 3, 6 and 12 months post intervention. The trial will test whether the Men Making a~     Difference Health Promotion Intervention increases self-reported physical activity compared~     with the Health Awareness Control Group.~   "
37025|NCT02572401|"~     African American men have by far the highest rates of HIV in the US, but there are few~     randomized controlled trials (RCTs) of interventions to dissuade heterosexually active~     African American men from engaging sexual risk behavior. This research seeks to address this~     gap in the behavioral intervention literature. That self-initiated behavior change, as well~     as intervention-induced behavior change, is often short-lived, eroding over time, is widely~     known; accordingly, this research also seeks to test a strategy to sustain intervention~     efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected~     intercourse with a woman will be randomized to the Steering Together in a New Direction~     (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a~     strategy to sustain intervention effects, the men also will be randomized to receive or not~     receive individually tailored text messages. The theoretical basis of the interventions is~     social cognitive theory and the reasoned action approach, which is an extension of the~     theory of planned behavior and the theory of reasoned action. Men will complete self-report~     measures via audio computer-assisted self-interviewing at baseline and immediately post and~     6 and 12 months post-intervention. The trial will test whether the STAND HIV Risk Reduction~     Intervention as compared with the No-Intervention Control Condition, increases consistent~     condom use, the primary outcome. Secondary outcomes include unprotected intercourse,~     multiple sexual partners, insertive anal intercourse, and proportion condom-protected~     intercourse. The trial will also test whether STAND's efficacy is greater among men in the~     Text Messaging Intervention compared with men not receiving text messages. This will provide~     information on the utility of a low-cost strategy to extend an intervention's efficacy.~     Finally, the study will test for mediation of intervention effects: the hypothesis that~     STAND affects outcome expectancies and self-efficacy, which, in turn, affect consistent~     condom use.~   "
37026|NCT02572388|"~     This is a clinical trial in which healthy volunteers will be administered one or two~     experimental malaria vaccines. The vaccine R21 will either be administered alone or in~     combination with the adjuvant vaccine Matrix-M1.~      All vaccinations will be administered intramuscularly. Each volunteer will receive three~     vaccinations in total.~      There are three different vaccine schedules:~      Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.~      Group 2 will receive 50µg of R21 on days 0, 28, and 56. .~      Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.~      The study will assess the safety of the vaccines, and the immune responses to the~     vaccinations. Immune responses are measured by tests on blood samples.~      Healthy adult volunteers will be recruited in Oxford and London, England.~   "
37027|NCT02572375|"~     The objectives of this pivotal study are:~        1. to evaluate bioavailability of an extended-release and immediate release Codeine~          Phosphate/Guaifenesin tablet at steady state following multiple oral administration~        2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended~          release formulation.~   "
37028|NCT02572362|"~     Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and~     volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients~     having had radiation therapy for rectal cancer. Twenty-five patients are included in this~     study. Planning CT scans are used for comparison of dose distribution and calculation of~     second cancer risk.~   "
37660|NCT02564094|"~     This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with~     subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies~     or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample~     size is 60 individuals.~   "
37029|NCT02572349|"~     The objectives of the study are to assess the safety and tolerability of a range of single~     doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the~     pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701~     when administered as oral capsules to healthy subjects.~   "
37030|NCT02572336|"~     This study will test the experimental drug THR-18 given together with the drug tissue~     plasminogen activator for the treatment of stroke. Tissue plasminogen activator is also~     called tPA.~      Strokes often result from blockade of blood supply caused by blood clots forming within the~     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of~     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before~     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA~     when it is injected into a vein shortly after the stroke starts. However, along with~     breaking up the blood clot, tPA sometimes causes adverse effects, for example, it may cause~     bleeding. THR-18, the drug tested in this study, is meant to reduce tPA's adverse effects~     without stopping tPA's breaking up of the blocking blood clot.~      The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke~     patients who are treated in parallel with tPA, to measure tPA's effect on blood clot~     dissolution when this drug is given with and without THR-18, and to study the effects THR-18~     may have on signals of brain damage as seen on brain computerized tomography (a type of~     brain x-ray) after treatment with tPA with and without THR-18. Patients will also be~     evaluated for their ability to perform daily activities after the stroke following tPA~     treatment with and without THR-18.~      The evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a~     drug that looks exactly like THR-18 but has no activity. One dose of THR-18 will be tested,~     in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients~     are planned to participate in this study. The decision whether a patient will receive THR-18~     or placebo will be based on chance (this procedure is called randomization). This clinical~     study will be conducted only at one hospital, in the Republic of Moldova. The patients will~     be in the hospital for at least 3 days after receiving the study treatment. Then, about 1~     month later, they will be invited for a last follow-up visit.~   "
37031|NCT02572323|"~     The aim of this study is to test whether tesamorelin, in combination with a text-messaging~     application to help with motivation and adherence, will significantly improve memory and~     thinking in HIV.~   "
37032|NCT02572310|"~     In this study the investigators propose to monitor subjects who have received Triathlon~     total knee components inserted with HV cement. The primary outcome will be fixation of the~     tibial implant component as assessed with RSA and to determine the functionality of patients~     after surgery using self-reported questionnaires. This is a historical control study,~     comparing the study cohort to a previous group with Triathlon implants and the long-standing~     Simplex T cement. The secondary outcomes are inducible displacements of the implants as well~     as a qualitative evaluation of the cement handling characteristics performed by the~     operating room staff.~   "
37033|NCT02572297|"~     Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient~     associations involved in epilepsy. These represent a priority for the Ligue Française Contre~     l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years,~     suffering from epilepsy uncontrolled by medication. In this population of close to 100,000~     people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per~     year. It is clear that the majority of these deaths occur in the immediate consequences of a~     crisis..~      Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per~     / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution~     of a cohort of 1500 patients clinically well described and a national database will allow~     other ambitious projects in a speciality where French centres benefit from a unique~     knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE~     (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such~     exploratory studies for the next two years.~      The high death rate which characterizes the drug-resistant partial epilepsies and, in~     particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of~     research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of~     epileptic patients and the European representatives of the international league against~     epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned~     against SUDEP.~      Although the SUDEP physiopathology remains uncertain, many elements plead for the essential~     role of a per-and post-critic apnea (central or obstructive). Investigators observe that~     about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their~     crisis are going to present experience an per / post-critic severe apnea, severe per /~     post-critic enough to have induce a SpO2 < 80 % decrease.~      However, today, no study has estimated the link relation between the arisen occurrence of~     such apneas and the later risk of SUDEP.~   "
37034|NCT02572284|"~     The purpose of this study is to compare the effects, good and/or bad, of different doses of~     SBRT given before prostatectomy. Depending when participants enter the study, they will be~     treated with either 5, 6 or 7 gray (Gy) per day of radiation. A Gy is a measure of radiation~     dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and~     no surgery is planned. The researchers want to see which dose of radiation will work best~     with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a~     prostatectomy.~   "
37035|NCT02572271|"~     The purpose of this study is to compare two different techniques of mastopexy with~     autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and~     Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one~     technique is superior to the other.~   "
37036|NCT02572258|"~     The study will evaluate the impact of a supplementary food (cookies) in preventing the risk~     of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.~      Children will be divided in two groups; one will received the cookie plus 12 educative~     sessions and the other just the educative program. The study will last 12 months~   "
37037|NCT02572245|"~     This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC)~     injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects~   "
37038|NCT02572232|"~     The purpose of the study is to compare three supraglottic airway devices (Combitube,~     Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway~     scenario in a pediatric manikin.~   "
37039|NCT02572219|"~     Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a~     nutraceutical preparation on early markers of cognitive impairment, in patients affected by~     arterial hypertension.~   "
37040|NCT02572206|"~     The primary goal of the present study is to evaluate the utility of mGluR5 binding as~     measured by PET as a biomarker of the CNTNAP2 mutation and related /mTOR kinase pathway~     dysregulation.~   "
37041|NCT02572193|"~     This is a study of an investigational surgical procedure for the treatment of achalasia the~     inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM~     procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is~     being performed to determine if patients can go home on the same day as their procedure.~   "
37064|NCT02571894|"~     The main objective of this randomized controlled trial is to test the association between~     standard cardiac risk factors, biomarkers and parameters of echocardiography,~     electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent~     occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome)~     within and between-groups, before start of chemotherapy, during treatment and at 1, 5, and~     10 years after the completion of the chemotherapy among women with early breast cancer.~   "
37042|NCT02572180|"~     This study aims towards investigating the efficacy of a near-infrared spectroscopy~     (NIRS)-based neurofeedback training in a virtual reality (VR) classroom in schoolchildren~     with attention-deficit/hyperactivity disorder (ADHD). The investigators are especially~     interested in the training's impact on academic performance, executive functioning (EF) and~     behavioral ADHD symptoms. Furthermore, the investigators aim at examining the influence of~     teachers' instructional behavior on children with ADHD's learning in a short virtual reality~     classroom scenario. Several studies provide evidence that poor academic achievement in ADHD~     is mainly due to impairments in EF and ADHD behavior (e.g., Frazier, Youngstrom, Glutting, &~     Watkins, 2007; Miller et al., 2013). Furthermore, studies show that these factors are~     related to neurophysiological characteristics found in electroencephalographic (EEG) or~     functional NIRS (fNIRS) examinations (e.g., Barry, Clarke, & Johnstone, 2003; Barry,~     Johnstone, & Clarke, 2003; Loo & Barkley, 2005; Negoro et al., 2010). Neurofeedback~     trainings aim at improving these neurophysiological as well as cognitive-behavioral deficits~     (Gevensleben, Moll, Rothenberger, & Heinrich, 2014), and are expected to improve academic~     performance in children with ADHD accordingly. Training in a VR classroom, from the~     investigators' perspective, facilitates generalization of self-regulation competences to~     real-life academic situations and at the same time increases the effort invested into the~     training compared to a training in 2D settings. Consequently, training in a VR classroom is~     hypothesized to lead to greater improvement in academic performance, EF and a greater~     decrease of ADHD symptoms than a training in a 2D setting. Moreover, the investigators~     hypothesize that these effects are more pronounced in children who receive a NIRS-based~     neurofeedback training compared to children receiving a biofeedback training based on an~     electromyogram (EMG).~   "
37043|NCT02572167|"~     The purpose of this study is to assess the safety profile and antitumor activity of~     brentuximab vedotin administered in combination with nivolumab in patients with relapsed or~     refractory Hodgkin lymphoma (HL)~   "
37044|NCT02572154|"~     In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while~     etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals'~     studies, several studies have underlined the importance of sperm quality for a normal embryo~     development. In human, epidemiological studies have demonstrated that several male risk~     factors have effects on development (male mediated development toxicology). However, few~     studies have explored sperm DNA fragmentation on embryo development but after in vitro~     fertilization. In natural pregnancy only rare studies have been performed but with different~     populations definitions and different methods of sperm exploration. In this context sperm~     DNA fragmentation exploration appears justified. The present study purpose to conduct a case~     - control study in order to research paternal role in RPL.~   "
37045|NCT02572141|"~     BACKGROUND:~      In patients with high risk stage II and stage III colon cancer (CC), curative surgery~     followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard~     treatment. However, 20 to 30 % of these patients will develop distant metastasis, which~     ultimately result in death. Perioperative chemotherapy is a promising strategy with~     potential benefits that could be more effective at eradicating micrometastases. Moreover,~     shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon~     but also reduce tumor cell spreading during the procedure. With recent advances in~     radiology, preoperative computed tomography is a robust method for measuring the depth of~     tumor invasion and identifying the CC patients with poor prognosis, who may benefit from~     perioperative chemotherapy. The investigators conducted the present randomized study to~     explore whether perioperative chemotherapy with FOLFOX or CAPOX regimens compared with~     postoperative chemotherapy could improve disease-free survival in patients with~     radiologically staged, locally advanced, but resectable colon cancer.~      OBJECTIVE:~      The primary objective of this study is to evaluate the efficacy of perioperative~     chemotherapy with FOLFOX or CAPOX regimens compared to postoperative chemotherapy in~     patients with locally advanced colon cancer. Secondary objectives are efficacy in terms of~     R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of~     primary tumors, and tolerability of perioperative therapy and postoperative complications.~   "
37046|NCT02572128|"~     The investigators studies will compare iron, respectively iron and zinc bioavailability from~     fortified rice produced from different fortification techniques using stable isotopic~     labels. Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in~     Study 2 the iron and zinc bioavailability from rice using one coating technique and hot~     extrusion will be compared.~   "
37047|NCT02572115|"~     The purpose of this randomized controlled trial is to test the use of an emergency button~     that allows patients to jump the telephone waiting line at the out-of-hours primary care in~     two regions in Denmark if they perceive their illness as acute and severe.~   "
37048|NCT02572102|"~     To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.~   "
37049|NCT02572089|"~     To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg~     dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose~     that could achieve systemic exposure comparable to an approved parenteral dose. To also~     determine the pharmacokinetics of two different concentrations of intranasal naloxone and~     finally, to determine the safety of intranasal naloxone with respect to nasal irritation.~   "
37050|NCT02572076|"~     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a~     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.~   "
37051|NCT02572063|"~     The overall objective of the study is to stratify a frailty population based on nutrients~     profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low~     molecular weight metabolites in urine and plasma) at baseline.~   "
37052|NCT02572050|"~     Designed as a single arm multi-center prospective phase II trial, which evaluates the number~     of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2~     lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric~     cancer.~   "
37053|NCT02572037|"~     An observational study on the effect of new classification for premature ejaculation.~   "
37065|NCT02571881|"~     Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may~     further impair bowel function. The aim of the present study was to evaluate if~     oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients~     undergoing caesarean section.~   "
37066|NCT02571868|"~     AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular~     function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of~     echocardiography. St Jude Medical has developed an automated algorhythm which calculates the~     optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2~     minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead~     position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm~     performance in the mid- and long-term with RV lead located in mid-septum.~   "
37054|NCT02572024|"~     Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These~     patients are at a clearly increased risk for end organ damage and mortality. Furthermore,~     arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary,~     metabolic, and sympathetic factors. However, the current treatment modalities have not been~     optimal in targeting the compensatory changes in sympathetic nervous system function and new~     strategies have been warranted.~      Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH~     that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in~     BAT both long-term safety and efficacy in a large-scale, randomized, double blind,~     controlled trial has been shown. However, the trial design and BAT methodology resulted in~     that the first generation Rheos® system did not achieve the prespecified endpoints for~     short-term safety and efficacy.~      Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been~     developed to address these limitations although randomized, double blind, controlled~     clinical trials are still lacking. Noteworthy, in the recent European Society of~     Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of~     arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options~     to treat resistant hypertension.~      Based on these data the aim of this randomized, double-blind, parallel-design clinical trial~     is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as~     well as arterial and cardiac function and structure using non-invasive high technology~     methodology, in a Nordic multicentre study.~      This study will include 100 patients with RH (20 from Helsinki). Eligible patients are~     between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or~     more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after~     witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs~     preferably including a diuretic), with no changes in medication for a minimum of 4 weeks~     prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric~     illness, severe cardiovascular disease, or any complication that is a risk to the planned~     surgery are exclusion criteria.~      The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood~     pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end~     points are to test whether BAT reduces home blood pressure during follow-up compared to~     continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up~     compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured~     as eg. baroreflex sensitivity and heart rate variability.~   "
37055|NCT02572011|"~     Lower limb amputees have reduced joint mobility and strength which negatively influence an~     individual's ability to maintain balance. Individuals with lower limb amputation also have~     an increased fear of falling and reduced social participation because of this fear.~     Improving balance ability, reducing falls and fear of falling through effective balance~     training interventions would have a number of socio-economic benefits. The aim of the~     current study is to investigate whether taking part in a games console based-balance~     intervention, improves balance ability in individuals with lower limb amputation.~   "
37056|NCT02571998|"~     The primary objective of this study is to evaluate the safety and efficacy of Omiganan~     (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in~     female subjects with moderate to severe inflammatory acne vulgaris.~   "
37057|NCT02571985|"~     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect~     confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac~     Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular~     Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and~     iliac aneurysms~   "
37058|NCT02571972|"~     This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and~     functional response to intravitreal anti-vascular endothelial growth factor (VEGF)~     injections in non-responders with wet age-related macular degeneration.~   "
37059|NCT02571959|"~     Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to~     healthy voluntary obese after oral and intra venous administration Determination of the~     pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic~     concentrations of intravenous injection (IV) and oral administrations. The criterion of~     evaluation allowing to answer our main objective corresponds to the parameters estimated by~     the pharmacokinetic model of the concentrations obtained from the data IV and by the~     pharmacokinetic model of the concentrations obtained from the oral data. The following~     pharmacokinetic parameters will be considered at every obese volunteer's for both molecules~     (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of~     population.~      The main evaluation criteria are PK parameters of amoxicillin / clavulanic:~        -  Cl, systematic plasmatic clearance~        -  Vd, volume of distribution~        -  ASC 0-oo, area under the curve time - concentration~        -  T1/2, half-life time~        -  F, bioavailability after oral administration~        -  Ka, constant of speed of absorption~   "
37060|NCT02571946|"~     The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the~     agent showed clear survival benefit in two randomized phase III trials, the benefit was~     modest and response rate was just a few percent. Therefore, other loco-regional modalities,~     like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy~     (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC~     including portal vein tumor thrombosis (PVTT).~      With the advancement of conformal RT techniques, RT was actively applied in HCC, especially~     in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose~     and tumor response rate. RT dose, however, is frequently limited because the complications~     (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity,~     etc.) are also closely related with higher exposed RT dose.~      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.~     The advantage of this dose distribution could be more highlighted in HCC management, because~     of the weakness and maintenance importance of liver function itself in HCC patients. In~     fact, the superior results of proton beam therapy in HCC were constantly reported in several~     groups as prospectively as well as retrospectively.~      In those background, the investigators planned the present study to evaluate the efficacy~     and safety of proton beam therapy in HCC patients combined with PVTT.~   "
37061|NCT02571933|"~     This study evaluates the face validity and cultural acceptability of the Faces Pain Scale -~     Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province,~     Cameroon. Participants from the four major language/cultural groups evaluated at the~     hospital with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo~     cognitive interviewing to assess comprehension and clinical accuracy.~   "
37062|NCT02571920|"~     Describe the proportion of patients who underwent cardiac surgery in France and benefiting~     from a monitoring cardiac output, describe the use of positive inotropic and vasoactive~     agents for cardiac surgery patients operated (type of catecholamines, their duration),~     describe the fluid replacement and transfusions of first 24 hours, describe the incidence of~     postoperative complications in patients undergoing cardiac surgery.~   "
37063|NCT02571907|"~     The purpose of this extended study is to evaluate the safety and effectiveness of the~     Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially~     available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac~     aneurysms.~   "
37067|NCT02571855|"~     The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or~     amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of~     ACT-541468 following multiple ascending doses in healthy adults and following single~     ascending doses in healthy elderly subjects when administered in the morning. The safety, PK~     and PD of ACT-541468 will also be assessed after repeated evening administration of a~     selected dose in both healthy adults and elderly.~   "
37068|NCT02571842|"~     Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and~     largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline~     for the care of kidney transplant recipients has concluded that there are no definite~     strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney~     is common and may contribute to graft loss, in particular, if cresentic formation, extra- or~     endocapillary proliferation were presented in kidney pathology. Herein, the investigators~     assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently~     decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the~     investigators speculate that rituximab may have potential effect to reduce circulating~     polymeric forms of IgA and slow progression of recurrent IgAN.~   "
37069|NCT02571829|"~     The purpose of this study is to determine whether ribociclib are effective and safe in the~     treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).~   "
37070|NCT02571816|"~     The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in~     subjects with mild and moderate hepatic impairment to matched healthy subjects with normal~     hepatic function.~      This study will also assess the safety and tolerability of single-dose ASP2215 in subjects~     with mild and moderate hepatic impairment and matched control subjects.~   "
37071|NCT02571803|"~     The aim of the study is to determine, wheather strict dietary intervention with the use of~     the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary~     atherosclerotic lesions assessed witch coronary computed tomography.~   "
37072|NCT02571790|"~     The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the~     rise of quality of life when using methods of relaxation combined with virtual reality with~     patients suffering from generalized anxiety disorder in comparison of the effect of~     traditional relaxation therapy. Observe and evaluate the effect of perceived presence in~     synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic~     efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment~     of generalized anxiety disorder.~      It is a comparative, randomized, two groups study (29 in each group):~        -  Relaxation optimized virtual reality~        -  Classical relaxation (without Virtual Reality). The protocol comprised for each groups~          7 relaxing sessions (with or without virtual reality epending on the group). Each~          session lasted for approximately 30 to 35 minutes, including a 5-minute pause between~          immersive trials, in order to avoid cyber sickness in the virtual reality group.~      Expected results: a measurable therapeutic improvement produced by the combination of~     relaxation and virtual and its additional effect when compared to the traditional treatment.~      Measurements of variables and therapeutic effects will be carried out with psychometric~     measures.~      The creation process of the relaxing virtual environments has already been completed. The~     virtual environments are ready for use.~      The apparatus needed and in our possession include:~        -  A laptop for generating virtual environments~        -  A stereoscopic display~        -  Apparatus for physiological measurements~   "
37073|NCT02571777|"~     The purpose of the trial is to evaluate the efficacy and safety of two different doses of~     QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective~     QMF149 doses (QMF149 150/160 μg and QMF149 150/320 μg via Concept1 in poorly controlled~     asthmatics as determined by pulmonary function testing and effects on asthma control.~   "
37074|NCT02571764|"~     Children with moderate acute malnutrition will be recruited in order to receive an~     intervention which consists in the consumption of a single serving of SF-cookies daily,~     7-days a week for 12 months and 12 educational sessions on health and nutrition.~   "
37075|NCT02571751|"~     Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive~     Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to~     Augmentation Mammaplasty for Purpose of Cosmetic Surgery.~   "
37076|NCT02571738|"~     A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further~     Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment~     of Chronic Diabetic Foot Ulcers~   "
37077|NCT02571725|"~     Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten~     percent are attributed to hereditary syndromes, most commonly the result of mutations in the~     breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results~     in the inability to repair double-stranded breaks in DNA. Treating these tumors with~     poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors results in the~     specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment~     of ovarian cancer patients with PARP inhibitors has resulted in improved progression free~     survival (PFS), but not overall survival (OS). It's not completely understood why this is~     the case, but some preclinical studies using ovarian cancer models in mice have suggested~     that combining PARP inhibitors with immune system modulators like T cell checkpoint~     inhibitors improves long-term survival.~      Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination~     of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody~     Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.~   "
37078|NCT02571712|"~     A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%)~     in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently~     responsive to topical beta-blocker or prostaglandin analogues.~   "
37079|NCT02571699|"~     The aim of this study is to determine the minimum effective volume of LA in 90 % of patients~     (MEV90) required for US-guided subgluteal sciatic nerve block.~   "
37080|NCT02571686|"~     The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and~     severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief,~     steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation~     (arterial blood sample processed in a laboratory hemoximeter). The data obtained is~     submitted by pulse oximeter manufacturers to the FDA for device approval.~   "
37081|NCT02571673|"~     This study is being done to understand how survivors of head and neck cancer think they can~     make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the~     Survivorship Care Plan the best it can be. Once the investigators have your input and input~     from other survivors, they can make changes to HN-STAR, so that they can test this tool in a~     larger study. The larger study will tell them whether using HN-STAR improves the care of~     head and neck cancer survivors.~   "
37082|NCT02571660|"~     Asthma is a disease that represents a public health problem worldwide, there are several~     barriers, especially in pediatric patients with this disease, them, prevent the adequate~     control of their condition, in addition every day there are new processing aids for this~     entity; within these novel research we founded the relationship between decreased vitamin D~     serum levels and his role in the regulating of the immune response, also this relationship~     in the pathophysiology of this disease and responses in the event of infectious diseases of~     the respiratory tract which can exacerbate symptoms in pediatric patients. We have been some~     of clinical trials with the aim of improving serum levels of vitamin D in asthmatic~     patients, however, these studies have different sources of bias and thus far there is no~     solid evidence that favors or denies the relationship between asthma and vitamin D, this~     paper aims to help generate this evidence to improve clinical management of these patients~     and their lung function and increase the free time crisis.~      In this trial two study groups which are divided for each of the interventions described~     below:~      Group low supplementation dose: 1 tablet of 400 IU was administered every 24 hours via oral,~     regardless of time or if it is before or after food, preferably in the morning to improve~     adherence to treatment, will be completed one year of treatment without suspension.~      Group high supplementation dose: 1 tablet of 1600 IU should be administered every 24 hours~     via oral, regardless of time or if it is before or after food, preferably in the morning to~     improve adherence to treatment, will be completed one year of treatment without suspension~     thereof.~   "
37083|NCT02571647|"~     Visual disorders are often overlooked in the treatment of cognitive disorders of the~     elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy~     and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to~     evaluate the prevalence of visual disorders among elderly patients at consultant outpatient~     center of Nantes clinical gerontology as part of the consultation geriatric memory.~     Secondary objectives are to describe ophthalmological diseases detected and taken into the~     proposed ophthalmic load, to determine if there are associations between eye diseases and~     cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic~     evaluation to determine the cognitive profiles and geriatric evaluation and ocular~     pathological, depending on the assessment of arterial stiffness. The results of this study~     will build a testing strategy to promote access of older patients with cognitive impairment~     to vision care.~   "
37084|NCT02571634|"~     The purpose of this study is to evaluate the effectiveness, feasibility and safety of~     intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to~     produce anxiolysis and improve patient comfort during and after radiofrequency ablations of~     the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to~     be feasible and safe for use during procedures, future larger scale studies can be done.~   "
37085|NCT02571621|"~     Retrospective evaluation of a database of ETC routine uses during general anaesthesia.~   "
37086|NCT02571608|"~     Type II Diabetes Mellitus patients having surgery who adhere to their regular scheduled~     metformin dosing and take this medication on the morning of surgery will have better~     glycemic control peri-operatively and potentially suffer less morbidity compared to~     individuals taking a placebo.~   "
37087|NCT02571595|"~     Sleep problems, such as insomnia, are more frequent and intense in individuals living with~     HIV. These sleep difficulties can increase the difficulties in thinking and concentrating.~     Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment~     intervention that provides strategies to improve sleep. This intervention has been shown to~     improve sleep and daytime function (concentration, productivity) in people with insomnia.~     However, the effects of this intervention in people living with HIV are unknown.~   "
37088|NCT02571582|"~     Advanced Pulmonary Disease (PAD) is a condition that affects countless individuals around~     the world. Patients are often functionally very limited, with premature death, which is due~     to the disease itself or its complications. Currently, there are numerous monitoring centers~     of these patients to increase survival, reduce costs and humanize care in these patients.~   "
37089|NCT02571569|"~     Investigate the safety, tolerability and pharmacokinetics of BAY 1093884 after Intravenous~     (IV) and subcutaneous (SC) administration of increasing single doses.~   "
37090|NCT02571556|"~     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate~     ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients~     having undergone cataract surgery with implantation of a posterior chamber intraocular lens~     (IOL)~   "
37091|NCT02571543|"~     During natural cycle in vitro fertilisation, no gonadotropin stimulation is used to~     stimulate oocyte production. Ovulation is induced with HCG (human chorionic gonadotropin)~     and the follicle is retrieved 36 hours later.~      In this study the patient will receive Ibuprofen as a study intervention beginning at the~     same time as the HCG injection. The treatment dose will either be 400mg every 8 to 12 hours~     or 800mg every 8 to 12 hours until the follicle retrieval, totalling 5 tablets. Instead of~     the usual time period of 36 hours, the follicular punction will occur after 42 hours. Should~     the oocyte still be accessible after this time period, then it is proven that Ibuprofen~     delays ovulation. In this case the patient will continue the regular NC-IVF treatment cycle.~      The study design is a admissible two-stage design. During stage 1, 8 cycles in 8 patients~     will be examined. Should it be the case that after these 8 patients have completed a cycle,~     4 or more show a positive treatment effect from the Ibuprofen intake, then the study will~     continue to stage 2 with 17 more more patients, totalling 25.~      Should it be the case however, that after 8 patients, 3 or less show an effect of the~     Ibuprofen intake, then the study will be stopped prematurely for futility. The study~     intervention will be increased to 800mg of Ibuprofen and the study will recommence with 8~     more patients.~   "
41532|NCT02513342|"~     Explore the efficacy and safety of the treatment of Endostar continuous intravenous~     injection pump combined DP scheme for first-line advanced lung squamous carcinoma and~     maintenance treatment., and explore the predicted biomarkers.~   "
37092|NCT02571530|"~     The purpose of this study is to evaluate the safety of administering a single dose of~     trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive~     breast cancer.~      This study will try to determine the best tolerated single dosage of trastuzumab~     administered into arteries by gradually increasing the dosage given to participants as the~     study progresses. Early participants will receive a dosage of 1 mg/kg. As more participants~     enroll into the study, this single dosage will be increased at designated levels up to 8~     mg/kg, if it's determined to be safe to increase.~      Trastuzumab is a type of antibody, which is a protein used by the body's immune system to~     fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors~     known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain~     cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor,~     trastuzumab can slow down or stop the over-expression of the HER2/neu protein.~     Over-expression of HER2/neu has been shown to play a role in the development and progression~     of certain types of breast cancer. Therefore, by slowing down or stopping the expression of~     HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase~     the responsiveness to therapy.~   "
37093|NCT02571517|"~     The purpose of this study is to to demonstrate that a 7-day course of systemic~     glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in~     paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding~     to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical~     ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory~     failure; duration of PICU stay and hospitalization; and exitus) between the treatment and~     the control groups.~   "
37094|NCT02571504|"~     Cognitive deficits in HIV reflect degraded brain network functioning that may be amenable to~     remediation through cognitive training. In this sub-study, we will make use of~     Plasticity-based Adaptive Cognitive Remediation (PACR), which applies well-understood~     techniques derived from brain plasticity and implicit/procedural/perceptual learning to~     improve the speed and accuracy of information processing, with exercises that are designed~     to drive generalized improvements. Simultaneously, these exercises heavily engage~     neuromodulatory systems to re-establish their normal control over learning and memory. As an~     individual restores these degraded abilities through intensive procedural learning, the~     encoding of naturalistic information significantly improves, and all resulting declarative~     memory and cognitive functions based on the quality of that incoming information necessarily~     improve as well, leading to improvement that generalizes beyond the trained tasks.~      A subset of 80 HIV+ individuals will undergo eight weeks of PACR to determine its~     feasibility and appropriateness for people with mild cognitive difficulties related to HIV~     infection. The results of this study are expected to be pivotal in generating data to create~     an optimal training program aimed at stabilizing or improving brain function in HIV infected~     individuals experiencing cognitive decline.~   "
37095|NCT02571491|"~     Comparison of the Efficacy of ketamine measuring the total consumption of morphine in~     pediatric patients with idiopathic scoliosis~   "
37096|NCT02571478|"~     The psychological health of military members is a critical element of force health~     protection and readiness. Frequent deployments and high operations tempo at home strain the~     relationships and families of today's military more than ever before (e.g., Karney & Crown,~     2007). Since 2001 the likelihood of divorce in the Air Force increased with the number of~     days that Airmen were deployed (Karney & Crown, 2007). Distressed relationships not only~     adversely affect members' adjustment and readiness (e.g., Hoge et al., 2006) but also are~     centrally implicated in suicides (i.e., relationship problems are the precipitating event in~     51% of Air Force suicides, Kindt, 2009) and domestic violence (Pan, Neidig, & O'Leary,~     1994). Unfortunately, traditional sources of marriage counseling available to service~     members are largely underutilized. The MC brings a fresh perspective that helps normalize~     relationship help-seeking and in turn reach larger numbers of distressed couples early. The~     partnering of MC and integrated primary care appears to be an ideal combination of~     behavioral health innovations that has the potential to measurably enhance relationship~     health for the military services.~   "
37097|NCT02571465|"~     To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume~     and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg~     Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.~      Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the~     transition from controlled to spontaneous breathing in cardiac surgery patients~   "
37098|NCT02571452|"~     The purpose of this study is to determine whether a brief, behavioral treatment for insomnia~     is effective in addressing social and occupational functioning and overall health among Iraq~     and Afghanistan Veterans with insomnia disorder.~   "
37099|NCT02571439|"~     The TAP is a space between the muscle layers of the abdominal wall that houses nerves~     supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space~     will block these nerves and prevent pain following c-section. The investigators will compare~     two different approaches to injecting the local anesthetic in this space. Conventionally,~     the block is done after surgery is completed and the abdomen is closed. The anesthesiologist~     introduces a needle through the abdominal wall skin under ultrasound guidance to reach the~     TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the~     abdominal (belly) wall and is closer to the inside of the abdomen than to the outside~     (skin), injecting from the inner aspect of the abdominal wall during the surgery is easier~     and quicker to perform than the conventional block and does not require ultrasound guidance~     as there is no risk of injury to abdominal organs like the liver.~      With this research the investigators attempt to prove that surgically administered TAP~     blocks take 25% less time to perform compared to the conventionally administered TAP block~     for post cesarean section pain relief. Surgical TAP blocks are also more cost-effective as~     in addition to reduced OR time, they are safer and do not require skilled operator and~     specialized equipment. Secondary outcomes will include total time spent in the Operating~     room, presence and severity of postoperative pain, time to first request for pain~     medication, total postoperative narcotic consumption in 48 hours after surgery and side~     effects.~   "
39337|NCT02542150|"~     This study plans to learn more about how alcohol and its metabolite, acetate, affect the~     brain during decision making. Investigators also want to learn how bacteria in the gut,~     known as the gut microbiome, affect how alcohol and acetate change the brain during decision~     making.~   "
37100|NCT02571426|"~     It is known that volatile anesthesia, such as sevoflurane, retain water and that this~     appears more pronounced in children. However, the mechanisms for this effect is unknown and~     it is not clear if the commonly used anesthetic propofol does the same. In this study the~     investigators want to compare the fluid and electrolyte conserving effects of sevoflurane~     and propofol in a pediatric setting and also investigate humoral changes induced by these~     anesthetics.~   "
37101|NCT02571413|"~     Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the~     treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS~     administration was created to decrease workload of health care professionals. The aim of~     this study is to compare the achievement of the children with AR in using INCS between the~     group which were instructed by animated cartoon-aided teaching or oral presentation without~     demonstration.~   "
37102|NCT02571400|"~     The purpose of this study is to determine the prevalence of delayed opioid cessation after~     surgery, where delayed opioid cessation is defined as patients taking opioids ≥90 days~     post-surgery. The study is also looking to determine specific patient factors that~     independently predict patients at risk of delayed opioid cessation.~      The study hypothesis is that 5-10% of patients will remain on opioid medications ≥90 days~     after surgery, and that pre-operative prescription opioid use, pre-operative perceived~     susceptibility to addiction, and symptoms of anxiety and depression will be associated with~     delayed opioid cessation post-surgery.~   "
37103|NCT02571387|"~     The purpose of this study is to evaluate the efficacy of a daily 12-month computerized~     mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED)~     on: impulsive eating, motivation toward exercise, and weight loss.~   "
37104|NCT02571374|"~     This is a double blind randomized trial in which patients with colorectal cancer undergoing~     surgery will be selected to receive either a symbiotic formulation or placebo. The~     researchers will compare incidence of surgical site infection between the study groups.~   "
37105|NCT02571361|"~     Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group~     clinical trial~      Trial acronym: PANSAID~      Background: Effective postoperative pain management is essential for the well-being and~     rehabilitation of the surgical patient. No gold standard exists after total hip~     arthroplasty (THA) and combinations of different non-opioid medications are used with~     virtually no evidence for additional analgesic efficacy compared to monotherapy.~      Objectives: The objective of this trial is to investigate the analgesic effects and safety~     of paracetamol and ibuprofen and their combination in different dosages after THA.~      Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400~     mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and~     ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.~      Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised~     computer-generated allocation sequence and allocation concealment with varying block size~     and stratification by site. Blinding of assessor, investigator, caregivers, patients, and~     statisticians.~      Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the~     first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004~     (two-sided) and a type 2 error rate of 0,10.~      We preplan the following sub-studies:~        1. A re-analysis of benefit outcomes (pain and opioid consumption) with respect to the~          following sub-groups: sex, age, ASA-score, type of surgery (uncemented, cemented, or~          hybrid), surgical site (posterior approach vs. anterolateral approach) and anaesthetic~          technique (general anaesthesia vs. spinal anaesthesia)~        2. A re-analysis of harm (adverse events and opioid related side effects) with respect to~          the following groups sex, age, ASA-score anaesthetic technique (general anaesthesia vs.~          spinal anaesthesia) and opioid consumption (in the intervention period).~        3. Longer follow-up than the specified 90 days (1 year)~        4. An analysis of the association between VAS-scores and opioid consumption~        5. Time-to-event analyses regarding use of PCA-morphine~        6. An analysis of the association between preoperative analgesic use and pain/morphine~          consumption~        7. An analysis of the individual patients: how many will achieve no worse than mild pain~          (NRS<3) More sub-studies may be performed post-hoc and they will be clearly identified~          as such.~   "
37106|NCT02571348|"~     This study is intended to investigate the optimum interval between micro-osteoperforations~     to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the~     rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated~     site. Next, the investigator will be comparing the rate of orthodontic tooth movement for~     micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the~     investigator will be evaluating the pain intensity and impact of pain on quality of life~     during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the~     investigator will be comparing the rate of orthodontic tooth movement between maxilla and~     mandible.~      The significance of the outcome is to determine optimum recommended interval for~     micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding~     out the optimum interval, the investigator can come with a recommended interval of~     micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth~     movement.~   "
37107|NCT02571335|"~     Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system,~     accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With~     chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS)~     progressively develop impaired functional capacity and show reduced physical activity and~     cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS~     are therefore to increase levels of activity and participation leading to increase~     independence of the participants. In general exercise ranges from passive~     physiotherapy-based interventions to submaximal endurance training sessions. Current~     recommendations advise pwMS that exercise should be matched with the individual performance~     capacities. Exercise training in pwMS then has the potential to target and improve many~     components outlined in the ICF-model.~      Cytokines and neurotrophic factors have received increased attention in MS research and~     addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal~     regeneration linking the effects of exercise with MS pathogenesis. Data show positive~     connections between elevated neurotrophin concentrations, induction of neuroplasticity,~     recovery of the motor and cognitive functions and the applied training intensities.~     Similarly, intensive and progressive exercise bouts seem to have greater benefits on~     cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with~     dementia. Therefore, specific exercise prescriptions may be necessary for targeting the~     specific impairments also in pwMS.~      This study aims to evaluate two different training modalities (intensive versus normal) in~     pwMS. It is expected that both modalities will improve cardiorespiratory fitness and~     cognitive functions in pwMS. Based on the findings that higher training intensities~     facilitate greater benefits, it is expected that pwMS will tolerate the intensive training~     intensities and show positive connections to elevated neurotrophin concentrations.~      The results will to help to clearer understand the benefits of each type of exercise~     conveyed for pwMS and will assist in the development of patient-specific exercise~     prescriptions.~   "
37108|NCT02571322|"~     The purpose of the study is to determine the effect of whole-body vibration (WBV) on body~     composition, physical fitness, and quality of life.~   "
37135|NCT02570971|"~     Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global~     public health concern. In the US, the vast majority of ciguatera poisonings occur in~     Florida, followed by Hawaii and California. Equipoise exists in the medical literature~     regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While~     there are many case reports attesting to its utility, the only randomized control trial~     (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit~     from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose~     a second, larger RCT to test this question.~   "
37109|NCT02571309|"~     Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control~     test (ACT/C-ACT) and health-related quality of life (HR-QoL) compared with conventional~     asthma management.~      Secondary aim: Evaluating patients´ medical adherence by using Asthmatuner compared with~     conventional management.~      Total sample size: Approximately 43 females and males with diagnosed asthma at the age of 6~     years or more will be evaluated.~      Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over~     to at least 16 weeks.~      Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited;~     (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska~     University Hospital, and (2) adolescents and adults from the primary health care sector in~     Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of~     asthma control, a score less than 20 will be required for inclusion.~      Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung~     function with external spirometry. The app gathers the information to define patients´~     asthma control. Subsequently, Asthmatuner provides the patient with a treatment~     recommendation based on the individual treatment plan.~      Procedures: Participants are randomized (1:1) into the one of two-arms of asthma~     self-management with Asthmatuner - conventional or conventional - Asthmatuner.~     Questionnaires will collect information about asthma control, HR-QoL, Medicine adherence~     report scale (MARS) and history of medical health concerning health care utilization and~     personal costs and income.~      Analysis: The study hypothesis will be tested by examining difference in patients´ change in~     asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each~     management period as mean scores and analysed by paired t-tests.~   "
37110|NCT02571296|"~     This is a randomized, double-blind, placebo-controlled study.~   "
37111|NCT02571283|"~     A prospective, randomized control study will be conducted to compare postoperative pain~     control in a series of patients treated with either:~        1. a local cocktail.~        2. a local cocktail plus Exparel.~        3. marcaine plus Exparel prior to wound closure following knee arthroplasty.~   "
37112|NCT02571270|"~     Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality~     of life (QL) in patients with heart failure (HF). It is believed that the combined aerobic~     and resistance physical training (CPT) supervised by physical educator is better than only~     prescription of unsupervised exercise. The aim of this study is to compare the effects of a~     CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the~     practice medical routine prescription of regular physical activity and correlate these~     findings with clinical and echocardiographic variables.~      Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly~     divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients~     undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients~     receiving only medical prescription to practice regular physical exercise. All patients were~     submitted to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL~     questionnaire before and after the study protocol. Student t test or Mann-Whitney test were~     performed for groups comparison and correlation tests for the same group variable~     associations.~   "
37113|NCT02571257|"~     The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid~     parameters in hypercholesterolemic patients on a stable dose of a statin.~   "
37114|NCT02571244|"~     The study is a preliminary research aimed to compare the effectiveness of motivational~     interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus~     on smoking cessation as the main outcome. Smokers patients receive brief interventions and~     nicotine replacement therapy during the hospitalization. After hospitalization discharge~     smokers will be allocated in a intervention or control arm. In the first and third months,~     after randomization, the patients will be contact to smoke abstinence assessment.~   "
37115|NCT02571231|"~     The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland~     University Hospital preparing a multi-center randomized, controlled unblinded cross-over~     study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).~   "
37116|NCT02571218|"~     In this study, the investigators aim to identify and characterize, by means of an EnSite~     Velocity Research Software, the electrophysiological characteristics of substrates that~     sustain AF in patients with persistent AF and to test whether ablation of such~     patient-specific substrates might improve the acute and long-term success of conventional~     catheter ablation therapy.~   "
37117|NCT02571205|"~     Observational study of clinical outcomes for testosterone treatment of pubertal delay in~     Duchenne Muscular Dystrophy is a single centre observational study that aims to follow the~     progress of 20 adolescents with Duchenne Muscular Dystrophy (DMD) and delayed puberty who~     are treated by the Newcastle muscle team, as they are treated with testosterone to induce~     puberty. The participants will all be treated with the standard stepwise regimen of~     testosterone injections every 4 weeks and data will be collected to help determine the~     effectiveness and tolerability of the current treatment regimen. The investigators will use~     the data to explore the effect of testosterone on pubertal development, growth, muscle~     strength and function, bone mineral density and body composition and characterise any side~     effects. Semi-structured interviews will also be carried out to learn the boys' views on the~     tolerability of the regimen. The study will last up to a maximum of 27 months in total for~     each participant, but may be less if they are happy with pubertal development before this~     time. It is important to do this study because from the investigator's limited experience in~     this group, testosterone treatment seems to be well liked and tolerated but the best~     treatment regimen to use remains unknown and there is no current consensus. It is not~     currently part of the standard of care in DMD but it would be important to include it if~     this study can show that it is an effective treatment for pubertal delay.~   "
37118|NCT02571192|"~     The purpose of this study is to determine how SHP626 is absorbed and excreted from the body~     in healthy males.~   "
37119|NCT02571179|"~     Physiological changes during pregnancy are known to affect the pharmacokinetics of many~     drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in~     pregnant patients has not been established. The investigators studied pharmacokinetics of~     intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal~     safety after administration.~   "
37120|NCT02571166|"~     The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers~     with HSV infection and to determine if administration of the HSV529 vaccine increases the~     immune response in genital skin.~   "
37183|NCT02570347|"~     Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous~     clinical trials that failed to show a benefit. But, none of these trials was done in India.~     Further, the species of snake in two of these trials was quite different from that seen in~     the Indian setting limiting generalization of these findings. Hence, home-grown evidence is~     needed to persuade clinicians to use antibiotics rationally.~   "
37121|NCT02571153|"~     There are evidences that intraoperative administration of low doses of ketamine may~     contribute to control the postoperative pain by acting on the NMDA channel, reducing the~     effects related to the tolerance and hyperalgesia induced by opioids. This study aims to~     evaluate the effects of administration of this agent not only as an analgesic but also its~     role in the quality of recovery from anesthesia, which includes observation of emotional,~     psychological and physical aspects. Patients who were scheduled to undergo total intravenous~     anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled in this clinical study.~     After induction of anesthesia, patients will receive one of three solutions according to the~     randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or saline. In the recovery~     room and on the ward, data related to the presence of pain, analgesic consumption, the~     incidence of nausea and vomiting, dizziness or hallucinations will be recorded. The next~     day, the quality of recovery will be evaluated by apllication of the questionnaire QoR40.~   "
37122|NCT02571140|"~     This study will have one stage consisting of multiple treatment visits. The study is~     designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male~     healthy volunteers in various formulation. The study is also designed to assess the~     reproducibility of pharmacokinetic profiles with various formulations.~   "
37123|NCT02571127|"~     Primary: Evaluation of improved vaginal moisture in postmenopausal women.~      Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation~     of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation~     of adherence to study treatment by patient diary, assessing the acceptability of the product~     and subjective assessment of the patient as the itching and stinging / burning, beyond the~     safety assessment.~   "
37124|NCT02571114|"~     A single site, blinded, randomized, controlled study designed to examine the glycemic and~     metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and~     females.~   "
37125|NCT02571101|"~     The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with~     CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug~     administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature~     Ejaculation~   "
37126|NCT02571088|"~     Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature~     reports that SCD patients display intolerance to exercise, important muscle weakness and~     profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular~     network.~      Because strenuous exercise induces acidosis, hemorheological alterations, endothelial~     activation and oxidative stress, it constitutes a potential triggering factor of sickling~     and vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in~     patients with SCD. However, moderate and regular physical activity seems to be not only safe~     but also beneficial for SCD patients.~   "
37127|NCT02571075|"~     The purpose of this study is to determine if auricular acupuncture significantly reduces~     post-operative pain in comparison to the standard of care. Post-operative pain score will be~     collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0=~     no pain, 10 = worst imaginable pain) up to 10 days post-operation.~   "
37128|NCT02571062|"~     Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of~     the tablet formulation used in the clinical trials and the final marketed tablet formulation~     under fed condition.~      The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate~     crossover study under fed condition. The 4-period sequences for the replicate design will be~     TRTR and RTRT, where R designates the reference formulation and T the test formulation.~     Subject will be allocated randomly to one of the two sequences of treatments according to~     the randomization list.~   "
37129|NCT02571049|"~     Pilot study to compare the efficacy and safety of two strengths of injections of~     subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.~   "
37130|NCT02571036|"~     This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to~     evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and~     preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with~     advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an~     expansion phase.~   "
37131|NCT02571023|"~     The purposes of this study are as follows:~        1. to collect the largest epidemiological data of skull base trauma and analyze the~          related influence factors of mortality and morbidity.~        2. to establish a set of standard classification methods of skull base trauma and to~          establish a standard rating scale for each type of trauma.~        3. to select optimized conservative and surgical treatments of skull base trauma and to~          compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.~        4. to clear the epidemiological characteristics of the skull base trauma combined with~          paroxysmal sympathetic hyperactivity.~   "
37132|NCT02571010|"~     This study aims to demonstrate that somatosensory rehabilitation of pain associated with~     static mechanical allodynia has superior efficacy over placebo treatment as well as over~     spontaneous changes.~   "
37133|NCT02570997|"~     This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study~     will be conducted in two phases: a single ascending dose (SAD) phase Part A, followed by a~     multiple ascending dose (MAD) phase Part B. In Part A, subjects will receive one dose of~     study drug. In Part B, subjects within a cohort will receive the same dose daily for 14~     days. In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in~     order to identify the maximum tolerated dose (MTD).~   "
37134|NCT02570984|"~     This trial is a randomized, double-blind, placebo controlled trial designed to test whether~     two years treatment of preschool children aged 2-3 years of age at high risk for asthma with~     omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as~     reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2~     year observation period off study drug.~   "
37146|NCT02570828|"~     This is a study to evaluate thermal imaging as a technology to monitor the normal clearing~     of amniotic fluid from healthy newborns and newborns suspected of having a condition called~     transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device~     that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a~     non-identifiable image based on the heat pattern of an object. In this case, the object is a~     child's chest and back. It does not emit any radiation like an x-ray does.~   "
37136|NCT02570958|"~     Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an~     early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater~     than 80% after surgical resection. Screening tests have made it easier to identify small~     lung tumors. However, these tumors are often not visible to the naked eye, and surgeons~     cannot feel them, making them difficult to precisely locate and remove. For this reason,~     surgeons have become more reliant on image guided surgery for the removal of these tumors.~      The standard of care for locating and removing small lung tumors is microcoil-guided~     video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two~     separate physicians.~        -  First, patient is taken to radiology suite and radiologist inserts a microcoil near the~          lung tumor~        -  Second (usually occurs a few hours later), patient is taken to operating room; a~          surgeon uses an x-ray arm to find the microcoil within the lung and remove it~          surgically.~      A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were~     both removed. Until this evaluation, the surgeon does not know whether the tumor has been~     removed or not. While this method is safe, it is time consuming, uses staff resources, and~     requires bulky equipment to complete.~      In this study, we plan to develop and test a new method of identifying and removing small~     lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB)~     Robotic Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose~     of this study is to test the safety and reliability of the ENB-RIGGS surgery in the form of~     a pilot study.~      ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic.~     ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to~     the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor,~     and when viewed by the special robotic camera the tumour will fluoresce with a green hue~     allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the~     tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a~     pathologist.~   "
37137|NCT02570945|"~     The study population will consist of all elderly (65 and older) patients hospitalized at the~     Centre hospitalier universitaire de Sherbrooke. The patients who present a~     pharmacotherapeutic problem will be randomly allocated between intervention and control~     groups. Practically, the relevant data will be extracted from the Electronic Medical Record~     (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify~     pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in~     geriatrics to determine their clinical relevance and the modifications that can be made.~     Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and~     treating physician to establish the changes needed to optimize drug therapy. A geriatrician~     will also be available to assist the pharmacist in his initial assessment for particularly~     complex cases. For control patients, a CAS analysis will be conducted to identify patients~     with a pharmacotherapeutic problem but there will not be a formal discussion amongst the~     health care providers (usual care) and the physicians of the control group will provide~     usual care to their patients. The investigators believe that it is ethical to provide usual~     care to the control group since the beneficial impact on patients outcomes of the~     investigators' intervention has not been demonstrated.~      Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication~     committee and are based on the Beers criteria with an emphasis on drugs involved in the~     development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and~     older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active~     at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older:~     i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or~     memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase~     inhibitor or memantine are frailty indicators.~   "
37138|NCT02570932|"~     The purpose of this study is to analyze the potential clinical efficacy of intrathecal~     administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow~     mesenchymal stem cells in the treatment of patients with established chronic spinal cord~     injury (LEM).~   "
37139|NCT02570919|"~     The present study evaluates clinical outcomes and treatment-related toxicity following~     definitive ultra-high dose external beam radiotherapy delivered with two different regimens~     in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven~     technology enables the implementation of ultra-high hypofractionated Image-Guided~     Radiotherapy (IGRT) safely.~      Prostate cancer patients classified according to the current National Comprehensive Cancer~     Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate~     Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are~     eligible for this study.~      Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with~     state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on~     normal tissue sparing and delivery accuracy via the use of devices that ensure stability and~     beam location reproducibility. A rectal balloon with air filling will be used for prostate~     target immobilization and anatomical reproducibility, while a urethral catheter loaded with~     beacon transponders will be used to ensure set-up reproducibility and online target~     tracking. Previously untreated patients with intermediate-risk prostate cancer will be~     prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in~     a single-dose.~      Patients will be followed at one month post-treatment and every 3 months for up to 12 months~     (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will~     focus on urinary, rectal and sexual functions and will be assessed through validated~     questionnaires. Serum PSA values will be regularly acquired during follow-up. A~     multiparametric MRI will be performed at baseline, 6, 12 and 24 months following~     intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be~     performed within 15 minutes of the first treatment, to measure early physiologic changes,~     such as perfusion and ischemia, that may correlate with clinically relevant end-points.~     Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic~     response to therapy. The study will be continuously monitored for a minimum of 5 years. In~     the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment~     arms, the study will be terminated according to the stopping rule >3/first 15 patients.~   "
37140|NCT02570906|"~     This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate,~     respiration rate, posture, and activity level compared to reference devices in healthy adult~     subjects during a variety of situations including hospital room movements, talking, and a~     short bout of exercise.~   "
37141|NCT02570893|"~     This is a multicenter, randomized, open-label, phase III trail comparing adjuvant~     chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients~     undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell~     carcinoma.~   "
37142|NCT02570880|"~     This study evaluates the impact of dough fermentation times on the glycaemic index of the~     ensuing breads.~   "
37143|NCT02570867|"~     Structural and functional brain changes of primary open-angle glaucoma patient will be~     examined with fMRI. POAG patients and control group were examined with 3.0T magnetic~     resonance imaging. The gray matter, white matter and cerebrospinal fluid volume images will~     be obtained and analysed.~   "
37144|NCT02570854|"~     The study will assess the safety, tolerability and efficacy of CSJ137 in chronic~     hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level~     of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing~     the need for dosing with erythropoietin and intravenous iron in these patients.~   "
37145|NCT02570841|"~     Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds~     (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in~     g) immediately after to find out the exact skin temperature by which capsaicin initiates the~     application pain (heat pain threshold, HPT in °C) but also the temperature by which~     capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the~     investigators want to find out the mechanical pain threshold in g from topical capsaicin and~     to verify a prolonged effect of capsaicin on the pain thresholds.~   "
37162|NCT02570620|"~     Study of the contribution of ultrasound measurements of the uterine cervix related to the~     calculation of Bishop score. Evaluation of the period between cervical induction and~     delivery. Study of ultrasound data to improve the care of these patients requiring~     induction.~   "
37147|NCT02570815|"~     Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these~     lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done~     to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which~     removes a large amount of lung tissue For patients with small tumours saving as much healthy~     lung tissue as possible is important. Each lobe of the lung has smaller sections called~     segments. When a lung cancer is in one of these segments, it is possible to remove that~     segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared~     to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.~      With the advances in screening technology for lung cancer tumours, an increasing amount of~     very small lung cancer tumours are being found, and the demand for segmentectomy is~     increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult~     to view the tissue lines that separate each segment within the lobe. As a result, it is~     difficult for the surgeon to see exactly which pieces of tissue should be removed. Because~     of these challenges, many patients having robotic surgery will have a lobectomy, even if a~     full lobectomy is not needed.~      Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent~     advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to~     determine which segment the tumour is located in. Once identified, the surgeon will isolate~     the segment by cutting off the blood supply to that segment. Then ICG will be injected into~     a vein. It is expected that the entire lung, except the isolated segment, which will remain~     'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when~     viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will~     remove it. A pathologist will examine the excised tissue to ensure that the tumour was~     removed in its entirety. Once confirmed, the surgeon will end the procedure. If the~     pathologist determines that the segment removed did not contain the entire tumour, then the~     surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all~     participants will have the entire tumour removed from their lung.~   "
37148|NCT02570802|"~     The purpose of this clinical trial is to assess normal values of the cross-sectional area of~     peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.~   "
37149|NCT02570789|"~     The purpose of this study is to assess whether certain metabonomics and/or lipidomics~     features in correlation with pharmacokinetics before, during and after treatment with~     sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or~     pazopanib in metastatic clear cell renal cell carcinoma patients.~   "
37150|NCT02570776|"~     The prevalence of H. pylori infection in Pakistan is unknown and investigators want to~     assess it in dyspeptic patients utilizing UBT. At the same time investigators want to~     validate UBT sensitivity and specificity in Pakistani patients~   "
37151|NCT02570763|"~     The current study aims to examine the safety and feasibility of utilizing tDCS to enhance~     affect-laden episodic memory consolidation among adults with co-occurring alcohol use and~     anxiety disorders who have recently undergone detoxification as a step toward the~     translational clinical application of this approach.~   "
37152|NCT02570750|"~     The main purpose of this study is to assess the effect of smoking status on the success of~     Etanercept therapy in patients with moderate-to-severe psoriasis.~   "
37153|NCT02570737|"~     The RELAHP registry is a Latin-American multinational, multicenter, prospective~     observational registry-type cohort study, which pretends to identify clinical~     characteristics, clinical course, management and outcome of all forms of pulmonary~     hypertension (PH).~      All consecutively consented patients newly diagnosed with WHO Group I-V PH according to~     specific hemodynamic criteria on right heart catheterization at the participating centers~     will be enrolled. Patients will be followed six-monthly for a minimum of five years from the~     time of enrollment.~   "
37154|NCT02570724|"~     The injection of autologous blood Blood Patch (BP) into the epidural space is the standard~     treatment for headache associated with intracranial hypotension. It provokes cerebral~     vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever,~     sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch~     made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of~     blood patch. This alternative technique is simple to implement and does not have some of the~     specific blood pressure contra-indications. The study aims at comparing the Blood Patch~     group versus the HES Patch in terms of clinical efficacy , tolerance, satisfaction of the~     anesthetist, ease of implementation and effect of the injection of epidural anesthesia on~     cerebral blood flow within 24 hours.~   "
37155|NCT02570711|"~     To evaluate the Safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects~     with metastatic pancreatic cancer using standard response criteria~   "
37156|NCT02570698|"~     The primary objective of this study is to collect feces from premature infants over a five~     weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and~     Microbiome analyses and cell-based assays will be performed to identify individual~     components present in feces, which may contribute to the onset of irritation in the diapered~     area of premature infants.~   "
37157|NCT02570685|"~     This randomized controlled study will examine the effects of different interpersonal~     gratitude journals compared to a neutral control journal on psycho social outcomes.~   "
37158|NCT02570672|"~     Frailty is a geriatric syndrome which leads to poor health outcomes in older adults, such as~     falls, disability, hospitalization, institutionalization, and death. Due to the dramatic~     growth in the U.S. aging population and the health care costs associated with frailty~     (estimated at more than $18 billion per year), frailty is a major health care problem. There~     has been little research into potential pharmacologic interventions that would delay or~     reduce the incidence of frailty. Thus, the major goal of this study is to test metformin as~     a novel intervention for the prevention of frailty. The investigators propose that~     diabetes/insulin resistance and inflammation are major contributors to frailty, and that the~     use of metformin to modulate diabetes/insulin resistance and inflammation will prevent~     and/or ameliorate the progression of frailty.~   "
37159|NCT02570659|"~     A randomized controlled trial (RCT) to investigate the effect of a information video,~     consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder~     (WAD).~   "
37160|NCT02570646|"~     Using a single-arm trial design, this study will examine the feasibility and acceptability~     of evaluating QuitAdvisorDDS, a clinical decision support software application designed to~     facilitate implementation of evidence-based tobacco treatment interventions into the dental~     setting. The study will examine the feasibility and acceptability of evaluating the impact~     of the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts~     as well as provider knowledge, attitudes, and practices regarding tobacco treatment.~     Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up,~     while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy~     will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to~     serve as biochemical verification of smoking status.~   "
37161|NCT02570633|"~     The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment~     of migraine.~   "
37163|NCT02570607|"~     BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular~     complications. In practice, the problem is that the practitioner don't know the most~     opportune moment for the preoperative sample or what threshold used to classify our patient~     in patients at risk of cardiovascular complication or not at risk.~      The purpose of this study is to determine the best time to dose the preoperative BNP with a~     specific threshold being associated with it allowing the practitioner to assess more~     accurately the post operative cardiovascular risk patients and possibly offer them~     strategies taking different load.~      The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate~     preoperative operating room. Post-operative cardiovascular complications will be collected~     during hospitalization of the patient and by telephone contact on the 28th day, 90th day and~     6th postoperative months.~      The investigator then establish the threshold BNP most informative for both sampling times~     and then compare them to determine the most discriminating dosage and thus the most~     appropriate time for the determination of BNP.~   "
37164|NCT02570594|"~     The aim of the study is to investigate the temporal organization of autobiographical memory~     in patients with schizophrenia. Patients and control participants will be invited separately~     to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an~     automatic camera around their neck, which is called SenseCam®. Pictures obtained with~     SenseCam® will be later presented to the participants during the session of test. They will~     be asked to determine the chronological order of 12 pictures corresponding to 12 particular~     events of the tour. Then they will be asked to watch the complete sequence of photos from~     the tour and to determine the beginning and ending of the events that have occurred during~     the tour. According to the investigators hypotheses, patients should have difficulty to find~     out the correct chronological order of the photos and to determine the appropriate~     beginnings and endings of the events~   "
37165|NCT02570581|"~     Elderly people often suffer from chronic pathologies and they are given polypharmacy. In~     case of swallowing problems, the drugs are crushed and mixed in food, which alters the taste~     of food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs~     have nether been investigated. The MELA study is a one session hedonic test involving 16~     healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly~     prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8~     food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they~     will have a unique opportunity to communicate and propose solutions to this neglected aspect~     of malnutrition in elderly populations.~   "
37166|NCT02570568|"~     Our novel technique of pen-torch transillumination (PTI) uses a cheap and easily available~     instrument (Penlite-LP212®, Energizer®, Missouri, USA) to visualize superficial veins~     invisible to the naked eye. The investigators evaluate the efficacy of PTI in improving~     venepuncture success rate (SR) for patients with poor venous access.~      This prospective randomized controlled trial looks at adult patients aged 21 to 90 with~     difficult venous access (history of ≥3 consecutive attempts required for successful~     cannulation during the current admission) requiring non-emergent venepuncture. Patients will~     undergo venepuncture over the upper-limb using one of the following: Conventional~     venepuncture (control); Veinlite® (TransLite®, Texas, USA), a commercial transillumination~     device; PTI. Outcome measures are: successful cannulation within 2 attempts; duration of~     each successful attempt. Fisher's exact and Kruskal-Wallis tests will be performed.~   "
37167|NCT02570555|"~     The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of~     patients with strabismus may be reduced. The goal of this work is to study the possible~     amelioration of driving ability after strabismus surgery and to compare the driving~     capacities of patients with strabismus to a normal population; Patients will be tested~     before and after strabismus surgery using a driving simulator, binocular visual field and~     binocular visual acuity.~   "
37168|NCT02570542|"~     The purpose of this study is to study the impact of stem cell dose on outcome after~     autologous transplant.~   "
37169|NCT02570529|"~     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About~     40% of pancreatic cancer patients were diagnosed as locally advanced unresectable status~     without distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment~     modality for locally advanced pancreatic cancer. However, several adverse events of~     chemoradiation could lead unfavorable treatment results, which included unique~     gastrointestinal (GI) toxicities, such as ulcer and hemorrhage in the stomach and duodenum~     that are included in the radiation field. According to the study in the investigators~     hospital, 45% of locally advanced pancreatic cancer patients treated with CCRT suffered from~     GI ulcers, and among them, 65% of the patients experienced the significant hemorrhage~     events. Although these GI toxicities, the studies for radioprotective agents were limited.~     Albis® is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The~     investigators will investigate the radioprotective effect of Albis® for locally advanced~     pancreatic cancer patients treated with CCRT.~   "
37170|NCT02570516|"~     This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo~     carmine chromoendoscopy) in patients having Lynch Syndrome~   "
37171|NCT02570503|"~     This study will evaluate the use of a local injection around the knee (periarticular) during~     total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The~     injection is a combination of various medications which are thought to reduce pain levels.~      Approximately 128 patients will participate in this study, half of the patients will receive~     this injection during surgery and the other half will receive a saline (salt water)~     injection. Pain scores after the surgery will be compared between the two groups.~      All patients will also receive a long-acting (24 hours) morphine injection during surgery.~      The hypothesis is that those participants receiving intrathecal Duramorph and local~     periarticular injections will have improved pain scores and reduced narcotic use when~     compared with intrathecal Duramorph alone at 48 hours postoperatively.~   "
37172|NCT02570490|"~     Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an~     oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects~     with ABSSSI~   "
37337|NCT02568319|"~     This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese~     subjects.~   "
37173|NCT02570477|"~     Clostridium difficile infection (CDI) is a leading cause of hospital-associated~     gastrointestinal illness, associated with significant morbidity and mortality and has a high~     burden on health-care system. The incidence of CDI has increased to epidemic proportion~     worldwide over the past decade. Community-acquired CDI, elderly and hospitalized patients~     receiving antibiotics are the main group at risk for developing CDI.~      Currently, the first-line treatment for C. difficile-associated diarrhea includes cessation~     of the antibiotic implicated in the development of CDI, treatment with metronidazole or~     vancomycin and recently Fidaxomicin which is yet to be available in Hong Kong. However,~     disease recurrence is an increasing problem and 20% to 60% of patients experience at least~     one recurrence within a few weeks of completion of antibiotic treatment. Moreover, an~     increasing number of patients who require life-saving emergency colectomy experience~     persistent CDI after surgery. Until recently, an effective treatment against recurrent CDI~     is not available. Generally, repeated and extended courses of vancomycin are prescribed.~      Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to~     affected subjects has attracted great interest in recent years and is now recommended as the~     most effective therapy for CDI not responding to standard therapies. Systematic reviews of~     prospective trials, case series and one randomized controlled trial have shown an overall~     cure rate of close to 100%. More than 50% of patients stated they would have FMT as their~     preferred first treatment option if CDI were to recur.~      This proposal aims to investigate the efficacy of FMT as first line therapy in patients with~     severe CDI and to assess changes in the fecal microbiota after FMT using pyrosequencing~     techniques.~   "
37174|NCT02570464|"~     Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after~     abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during~     open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of~     reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs,~     including heart, kidney, and lung.~      Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues~     exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult.~     Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia~     followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection~     from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains~     unclear.~      The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by~     ischemia-reperfusion and thereby protect the remote organs.~      A single-center, prospective, randomized, parallel-group controlled trial is conducted on~     patients undergoing elective open infrarenal AAA repair. Written informed consent is~     obtained from each participant. The study protocol was reviewed and approved by the Research~     Ethics Committee of Rouen, France.~      Patients are divided in two groups : the sham-operated control group underwent surgery~     without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common~     iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion~     served as the RIPC stimulus, before prolonged ischemia.~      Blood samples are collected for analysis at the following time points: before surgery~     (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory~     response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10.~     Cardiac, renal and pulmonary functions are evaluated with usual biological markers and~     clinical monitoring until 28 days after surgery.~      Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible~     to study the impact of RIPC in humans. This biological approach would help to better~     understand the mechanisms underlying this technique.~   "
37175|NCT02570451|"~     The overall objectives of this study are to improve outcomes of surgical patients 65 years~     of age or older through risk stratification based on preoperative screening of cognition /~     mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients~     65 years of age or older presenting for elective joint replacement surgery by structured~     cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative~     cognitive impairment in patients 65 years of age or older undergoing elective joint~     replacement surgery is an independent predictor of adverse postoperative events and/or~     mortality. Aim 3 is to implement routine structured preoperative cognitive screening of~     patients 65 years of age or older undergoing elective surgical procedures in a busy~     preoperative clinic.~   "
37176|NCT02570438|"~     The hypothesis is that structured preoperative cognitive screening of seniors is feasible~     without specialized staff and can help preoperatively identify persons at high risk of~     complications. To demonstrate generalizability of the single center experience, and~     strengthen the case for routine preoperative cognitive screening of seniors, the aims of~     this proposal are to implement preoperative cognitive screening of seniors in the~     preoperative clinics of a community hospital (NWH) and a 2nd tertiary care institution~     (MGH); and determine whether impairment is an independent predictor of adverse perioperative~     events.~   "
37177|NCT02570425|"~     This study is conducted to assess the ease of device mastery of a placebo SYMBICORT~     TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals~     in-training (HCP).~   "
37178|NCT02570412|"~     Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.~   "
37179|NCT02570399|"~     This is a prospective, multicentric, phase II and feasibility study aimed to address early~     and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients~     with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.~   "
37180|NCT02570386|"~     The objective of the present randomized controlled study is to compare clinical~     effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer~     (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.~   "
37181|NCT02570373|"~     The purpose of this study is to characterize the elimination of guselkumab glycoform~     variants following a single intravenous (IV) administration of guselkumab at a 10 milligram~     per kilogram (mg/kg) dose in healthy participants.~   "
37182|NCT02570360|"~     The research study compares the substance abuse treatment outcomes (e.g., craving,~     withdrawal symptoms, rates of use, abstinence) of standard intensive outpatient care, with~     or without an added 6-wk aerobic exercise component. In addition, certain biomarkers~     associated with both exercise and substance use (e.g., endocannabinoids and cortisol) will~     be assessed. In a rolling admissions format over the course of a year, approximately 36~     treatment-seeking substance users who are currently receiving Intensive Outpatient Treatment~     through a local Alcohol or Other Drug Abuse agency will be randomized to either receive 6~     weeks aerobic exercise training in addition to standard care or standard care with 6 weekly~     laboratory visits to complete questionnaires (18 per group).~   "
37338|NCT02568306|"~     This trial is conducted in the United States of America. The aim of the trial is to~     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the~     body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but~     otherwise healthy subjects.~   "
37184|NCT02570334|"~     This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old~     children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby~     to provide complementary information to the trials CHER and PREDICT on the long term~     development of (1) HIV-infected children according to age at ARV initiation and (2) HIV~     exposed but not infected children, all compared with the control group of children~     uninfected, unexposed to HIV.~   "
37185|NCT02570321|"~     The primary purpose of this study is to determine if patients randomized to corneal collagen~     cross-linking plus medical therapy will have a lower prevalence of positive bacterial or~     fungal cultures immediately after the procedure than patients who received medical therapy~     alone.~      The secondary purpose of this study is to determine if patients randomized to corneal~     collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who~     receive medical therapy alone.~   "
37186|NCT02570308|"~     IMCgp100-102 is a Phase I study of the weekly intra-patient escalation dose regimen with~     IMCgp100 as a single agent in patients with metastatic uveal melanoma (mUM). According to~     this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose~     level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose~     escalation will commence at the third weekly dose at C1D15. The Phase I testing of the~     intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal~     plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter .~   "
37187|NCT02570295|"~     The purpose of this study is to determine whether the new sport concept of the Swiss Armed~     Forces influences the physical and psychological fitness of the recruits.~   "
37188|NCT02570282|"~     This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way~     crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A~     sufficient number of participants will be enrolled to yield 30 (approximately 15~     pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo~     Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).~   "
37189|NCT02570269|"~     The study has to show that an intubation with the AuraGain Laryngeal mask could bring the~     same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.~   "
37190|NCT02570256|"~     This study investigates the potential of customized robotic and visual feedback interaction~     to improve recovery of movements in stroke survivors. While therapists widely recognize that~     customization is critical to recovery, little is understood about how take advantage of~     statistical analysis tools to aid in the process of designing individualized training. Our~     approach first creates a model of a person's own unique movement deficits, and then creates~     a practice environment to correct these problems. Experiments will determine how the~     deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3)~     activities of daily living. The findings will not only shed light on how to improve therapy~     for stroke survivors, it will test hypotheses about fundamental processes of practice and~     learning. This study will help us move closer to our long-term goal of clinically effective~     treatments using interactive devices.~   "
37191|NCT02570243|"~     This is a prospective, multi-center, superiority study of parallel design. Patients are~     enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic~     coronary angiography and the interventional cardiologist is willing to proceed with radial~     access. Patients are randomized before diagnostic catheterization to receive intravenously~     either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are~     discharged usually within 4 to 6 hours after coronary angiography.~      Radial artery in each patient is evaluated either in-hospital or during a subsequent visit~     by one physician who is blinded to the actual antithrombotic treatment given. Radial artery~     is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at~     baseline and after reevaluation on a second occasion, within 30 days after the index~     procedure. Initially patent arteries will not be reexamined and are thought to remain~     permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL~     decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding~     (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined~     as those extending beyond the forearm).~   "
37192|NCT02570230|"~     Thoracotomy is one of the most painful operation. Continuous thoracic epidural or~     paravertebral analgesia are gold standard for postoperative pain. But both techniques~     require skills. Spinal morphine is alternative simple method with less efficacy. Adding low~     dose ketamine during intraoperative may be helpful in postoperative pain relief.~   "
37193|NCT02570217|"~     Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the~     following treatments as non invasive respiratory support if they develop mild to moderate~     Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2)~     HHHFNC providing a flow 4-6 l/min.~      The aim of the study is to assess efficacy and safety of relative new form of respiratory~     support (HHHFNC) versus a more common one (NCPAP).~   "
37194|NCT02570204|"~     This study aims to investigate the effectiveness and acceptability of the multi-level~     pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.~   "
37195|NCT02570191|"~     This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants~     with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and~     the target sample size is 60 individuals.~   "
37196|NCT02570178|"~     The objectives of this study are to evaluate the usefulness of an intervention utilizing the~     NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of~     falling as well as the number of falls, and to evaluate the correlation between balance as~     determined by the console and the value obtained in the Tinetti tests and the one foot~     stationary test.~   "
37339|NCT02568293|"~     The purpose of this study is to compare balloon angioplasty plus SBCV against balloon~     angioplasty alone for treatment of stenosis within the femoropopliteal artery.~   "
37340|NCT02568280|"~     This trial is conducted in Europe. The aim of the trial is to investigate the postprandial~     glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1~     diabetes.~   "
37341|NCT02568267|"~     This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101)~     for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene~     fusion. Patients will be assigned to different baskets according to tumor type and gene~     fusion.~   "
37197|NCT02570165|"~     Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled,~     double-blind, parallel group study primarily designed to assess the dose response, efficacy~     and safety of five dose regimens of batefenterol administered via the dry powder inhaler~     (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained~     from this study will be used to select the minimal, optimally effective and safe dose of~     batefenterol and also to evaluate the pharmacokinetic profile and established~     pharmacodynamic (PD) responses of batefenterol. These data will support for future studies~     with batefenterol in COPD subjects.~      The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks),~     treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration~     of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will~     be screened in order to randomize approximately 320 subjects, assuming that 280 subjects~     will complete the study. During treatment period, subjects will be randomized to one of the~     following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75~     mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and~     placebo. All subjects will receive supplemental albuterol/salbutamol to be used on an~     as-needed basis (rescue medication) throughout the study.~   "
37198|NCT02570152|"~     The purpose of this study is to determine the incidence of dengue fever and to build~     capacity for dengue vaccine trials in dengue-endemic regions of South Asia.~   "
37199|NCT02570139|"~     The purpose of the study is to evaluate the safety and efficacy of the investigational~     product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of~     incontinence associated dermatitis.~   "
37200|NCT02570126|"~     The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of~     GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.~   "
37201|NCT02570113|"~     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device~     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving~     the kidneys. The catheter is inserted via the femoral artery, steered into the renal artery,~     and then delivers, by infusion from its distal end, a neurolytic agent. This targets the~     nerve bundles, which are in the adventitia - a sheath surrounding the artery. The aim is to~     reduce blood pressure in cases of hypertension, including seriously elevated blood pressure~     which does not respond to drug treatment. This study will evaluate the safety and~     performance of the device.~   "
37202|NCT02570100|"~     From a cellular perspective, breast cancers appear to develop hierarchically from a small~     contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated~     with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus,~     these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and~     chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the~     reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the~     proportion of CSCs before any treatment is correlated with chemoresistance and that a~     resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the~     mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.~      The Oscar Lambret Center proposes a monocentric prospective interventional study based on~     the cellular and molecular analysis of the tumor, serum and circulating cells, before,~     during and at the end of the treatment for each patient receiving a neoadjuvant chemotherapy~     for breast cancer. The identification of the mechanisms contributing to the enrichment of~     CSCs resistant to chemotherapy could lead to therapeutic solutions.~   "
37203|NCT02570087|"~     The investigators studied the effect of CTO-PCI on left ventricular function and clinical~     parameters in patients with HFrEF.~   "
37204|NCT02570074|"~     Oral dosage regimens for fosfomycin tromethamine (Monurol™) are not established for the~     treatment of cUTI. The most common and recommended adult dosage regimen in the literature is~     a single-dose sachet containing the equivalent of 3 grams of fosfomycin administered every~     other day (QOD) for a total of three doses.~      There are a myriad of different oral fosfomycin dosing regimens currently being used in~     clinical practice, including up to 3 grams orally twice daily for 7-21 days, but these~     regimens are not based on solid pharmacokinetic, pharmacodynamic or safety rationale.~     Initial pharmacokinetic studies performed with oral fosfomycin tromethamine primarily~     examined single dose regimens and did not use modern day bioanalytical or pharmacokinetic~     techniques. As the use of fosfomycin becomes more pervasive in concordance with the increase~     in multidrug resistant pathogens, further pharmacokinetic and safety data are needed for~     more intensive dosing regimens to support its continued use.~      The rationale of this study is that oral fosfomycin tromethamine requires a modern~     pharmacokinetic-pharmacodynamic study to identify alternative oral dosage regimens that are~     appropriate and safe. This study will provide safety/tolerability and clinical pharmacology~     information regarding two oral dosing regimens that may have application to treat various~     types of infections involving resistant pathogens or when other oral antibacterial options~     are not available.~   "
37205|NCT02570061|"~     This study examined the use of the telephone for the purpose of informing expectant mothers~     about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.~     Expectant mothers who were contacted for participation in a vaccination trial (the Calmette~     study, NCT01694108) were randomized to receive information by telephone or at a face-to-face~     consultation. The primary outcome was a communication score, consisting of comprehension of~     information about the study and satisfaction with the information process. The outcome was~     measured using a questionnaire two weeks after the information was provided and two and a~     half months after birth.~   "
37342|NCT02568254|"~     This is a single-site, 8-visit, double-masked, cross-over study involving three marketed~     products as study lenses. Participants will be randomly assigned each lens type, which will~     be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a~     minimum washout period of 3 days before entering the study and undergo a minimum 7 day~     washout period between dispensing each lens type.~   "
37595|NCT02564952|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
37206|NCT02570048|"~     This is a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound~     that arrives at the ears naturally will be presented in the form of touch patterns on the~     tongue. By learning to associate the sounds in the ears with the sound patterns on the~     tongue, investigators aim to demonstrate that the brain will learn to discriminate the real~     sounds from legitimate external sounds from the imaginary tinnitus sounds that are created~     inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing~     in the ears' that affects an estimated 40 million people globally (American Tinnitus~     Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception~     of illusory sound that has no legitimate external source and normally arises from a small~     number of underlying neuropathologies. There are broadly two categories of tinnitus Somatic~     Tinnitus and Hearing Loss Related Tinnitus.~      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The~     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The~     objective of the study will be to determine the impact of acoustic and tactile multi-modal~     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and~     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking~     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale~     (VAS).~   "
37207|NCT02570035|"~     This purpose of this study is to investigate the effects of mirabegron on the cardiovascular~     system in patients with overactive bladder with current or a history of cardiovascular~     disease.~   "
37208|NCT02570022|"~     This is a randomized, single blinded, standard of care controlled clinical trial. All adult~     patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares~     pain control and opioid consumption in patients undergoing shoulder arthroplasty between~     patients receiving liposomal bupivacaine and those who underwent a preoperative~     inter-scalene nerve block.~   "
37209|NCT02570009|"~     Obesity risk is shared within married couples yet most existing weight loss programs focus~     on individuals and not the marital dyad. This project will test the effects of a couples~     weight loss program that teaches spouses how to provide each other with autonomy support and~     create an interpersonal environment that promotes sustained behavior change.~   "
37210|NCT02569996|"~     This study will evaluate the efficacy, safety, and tolerability of long-term maintenance~     therapy with rituximab in participants with advanced follicular lymphoma who have had a~     positive response to first-line treatment with a rituximab-containing regimen. The~     anticipated time on study treatment is 2 years, and the target sample size is 124~     individuals.~   "
37211|NCT02569983|"~     The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium~     term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated~     questionnaires in patients undergoing standard or extensive surgery for suspected or~     confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in~     these patients.~   "
37212|NCT02569970|"~     Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that~     primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP~     incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood,~     it appears that the majority of such death occurs in the immediate aftermath of a general~     tonic-clonic seizure.~      There is currently no validated preventive treatment for SUDEP. Some evidence suggest that~     modulation of the serotoninergic tone, and more specifically selective serotonin recapture~     inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents~     seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models~     of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the~     control of breathing, especially during sleep and in response to repeated hypoxia.~      In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of~     seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a~     risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs~     displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.~      The investigators project aimed at testing whether fluoxetine can reduce the risk of~     ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled~     trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of~     their focal drug-resistant epilepsy.~   "
37213|NCT02569957|"~     This randomized phase II trial studies the effects of acetylcysteine and topotecan~     hydrochloride on the tumor microenvironment, or cells that make up a tumor, compared to~     topotecan hydrochloride alone in patients with ovarian, fallopian tube, or primary~     peritoneal cancer that has not responded to treatment (persistent) or has returned after a~     period of improvement (recurrent) and is high grade (likely to grow and spread quickly).~     Research has shown that cancer cells may be able to convert nearby normal cells into cancer~     cells. Acetylcysteine may stop this from happening. Topotecan hydrochloride is a~     chemotherapy drug used to treat ovarian cancer, and may help acetylcysteine work better.~     This trial studies the effect of acetylcysteine and topotecan hydrochloride on the tumor~     microenvironment to see if they can help make it more difficult for tumor cells to grow.~   "
37214|NCT02569944|"~     Randomize trial by including patients up to 12 months old in whom a urine sample by a~     non-sterile method was requested under physician criteria. Intention-to-treat analysis was~     made.~      Urine dipstick was considered as altered if it was positive in leukoesterase test (≥2+) or~     nitrite test. In patients with an altered urine dipstick, a sterile sample was obtained for~     culture. If there was an initial altered urine dipstick with a subsequent negative urine~     culture it was considered as contaminated urine.~   "
37215|NCT02569931|"~     The principal objective of the study is to find out which everyday activities make the~     kneecap unstable in people with patellofemoral instability.~      Analysing how a patient with an unstable kneecap walks will help us to determine if surgery~     is successful in these patients by seeing if better scores on patient questionnaires are~     found in patients following surgery and whether these patients also have a better pattern of~     walking.~      The investigators aim to use cameras and pressure pads to see how patients walk before and~     after surgery and see how this compares to patient scores on the questionnaires.~      If the investigators find that patients walk better after surgery they can justify that~     surgery is worthwhile for the patient and cost effective for the NHS.~   "
47458|NCT02435849|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of CTL019 in pediatric patients with r/r B-cell ALL.~   "
37216|NCT02569918|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might~     be elicited or worsened by a range of physical factors (e.g. changes in the weather or~     pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well~     known that most treatments available for PLP today, such as pharmacological, surgical,~     anaesthetic, psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical~     reorganization and alleviation of phantom limb pain has been observed in amputees following~     intense use of a hand prosthesis. However, there is no consistent knowledge on which type of~     peripheral sensory feedback may be effective in affecting the cortical plasticity or on how~     to best apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
37217|NCT02569905|"~     Shivering is an early postoperative complication during the postoperative recovery period,~     and there is no clear consensus about the best way for its prevention. The aim of the study~     was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with~     that of parecoxib or placebo for reducing postoperative shivering.~   "
37218|NCT02569892|"~     This is a randomized controlled study of non-damaging photothermal macular grid laser versus~     sham laser therapy in patients with dry age-related macular degeneration (AMD) and large~     high-risk drusen. The goal of the study is to determine if this treatment will reduce~     macular drusen volume and also whether this might improve visual acuity or reduce the risk~     of conversion to advanced age-related macular degeneration defined as development of~     choroidal neovascularization or geographic atrophy.~   "
37219|NCT02569879|"~     This study is being conducted to assess impact of maternal immunisation against pertussis in~     infants ≤12 months of age before and after introduction of pertussis maternal immunisation~     in Bogota, Colombia from January 2005-December 2014.~   "
37220|NCT02569866|"~     This study was designed to determine the role of antibiotics reduction mammaplasty influence~     surgical site infections rates.~   "
37221|NCT02569853|"~     Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.~   "
37222|NCT02569840|"~     This study of the tolerance and acceptability of an amino acid based feed will assess~     gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste,~     smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid~     based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated~     conditions, over 4 weeks.~   "
37223|NCT02569827|"~     Dengue fever is an acute febrile illness transmitted by mosquitoes, which affects half the~     world's population. There are 96 million symptomatic infections, 500,0000 hospitalisations~     and 25,000 deaths per year attributed to the disease. The economic burden is $12 billion. In~     Singapore, as elsewhere, the incidence of the disease continues to increase despite~     aggressive control measures. At present there are no approved medicines for treating dengue~     fever. Only supportive fluid replacement therapy is used to treat vascular leakage in~     patients with severe illness. Therefore there is an urgent need to find alternative~     treatments. Experiments in the laboratory have shown that Celgosivir and modipafant inhibit~     dengue virus and improve mouse survival. Both drugs have previously been used in humans with~     good safety records, so investigators are taking this one step further to find out how well~     it works in dengue patients. Investigators plan to enroll dengue patients within 48 hours of~     fever onset and assign them to one of four treatment groups over five days. Together with~     the support from the industry partner, 60°Pharmaceuticals PLC, the investigators will~     determine the safety and effectiveness of these drugs on acute dengue patients and pave the~     way forward for dengue antiviral medicines to reach patients.~   "
37224|NCT02569814|"~     A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics~     and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus~     Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in~     Healthy Male Subjects.~   "
37225|NCT02569801|"~     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of~     GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic~     estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2)~     breast cancer resistant to aromatase inhibitor therapy.~   "
37226|NCT02569788|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal~     cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be~     treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD)~     in terms of acute and subactue toxicity observed during and within 4 months after the~     completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be~     used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II~     part of the trial.~   "
37227|NCT02569775|"~     The aim of this study is to assess the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in patients with cerebral palsy.~   "
37228|NCT02569762|"~     The Objectives of this study is to determine the effect(s) of daily non-caloric artificial~     sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and~     also to determine the changes in glucose metabolism.~   "
37229|NCT02569749|"~     To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and~     central, in patients with: 1) pacemaker indication; 2) implantable cardioverter~     defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and~     preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.~   "
37439|NCT02566993|"~     Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus~     cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as~     treatment in patients with small-cell lung cancer (SCLC) who failed one prior~     platinum-containing line to determine a difference in progression-free survival (PFS) by an~     Independent Review Committee (IRC) between lurbinectedin (PM01183)/doxorubicin (DOX) and the~     control arm (CAV) or topotecan and to analyze the median overall survival (OS) and mid- and~     long-term overall survival (OS at 12, 18 and 24 months).~   "
37230|NCT02569736|"~     Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on~     professional antigen-presenting cells, differentiate into different effector cells:~        -  Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against~          intracellular pathogens;~        -  Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses~          and immunity against parasites;~        -  Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by~          tissue cells.~      An additional TH subset called follicular helper T (Tfh) cells has recently been identified~     in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate~     B-cell maturation and immunoglobulin production during normal immune responses. They produce~     factors essential for B cell selection and maturation into memory B-cells or long-lived~     antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic~     autoantibody production in systemic autoimmunity, and therefore could potentially represent~     a novel therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is~     characterized by the presence of ectopic lymphoid structures, resembling germinal centers.~     Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and~     synthesis of pathogenic autoantibody production, thus potentiating tissue injury.~     Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the~     same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis.~      IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological~     progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6~     effects impact the observed clinical response. Recently, Samson et al have demonstrated that~     Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with~     RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B~     cell compartment. They showed a significant reduction in the frequency of peripheral~     pre-switch and post-switch memory B cells but also a reduction of serum immunoglobulin~     levels, that could be the reflect of TCZ on Tfh cells development, circulation and/or~     function.~      Most of the work studying the role of IL-6 on Tfh cells development has been performed in~     mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that~     cytokines alone are insufficient to drive Tfh cells differentiation.~      To better understand the impact of IL-6 on human Tfh cells, the investigators would like to~     conduct a prospective study in patients with active RA and investigated the effects of~     blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week~     study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be~     explored in vitro.~   "
37231|NCT02569723|"~     This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works~     in predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with~     colorectal cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Drugs used in chemotherapy, such as oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Carbon C 14 is a radioactive form of~     carbon, exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin~     diagnostic assay may help doctors understand how well patients respond to treatment and~     develop individualize oxaliplatin dosing in patients with colorectal cancer.~   "
37232|NCT02569710|"~     This randomized, open-label study will assess the safety, pharmacokinetics and efficacy of~     the orally administered combination of AL-335, ACH-3102, and simeprevir in treatment-naïve~     subjects with chronic hepatitis C (CHC) infection.~   "
37233|NCT02569697|"~     The purpose of this study is to develop markers for use of placebo vaginal products and~     measure markers of mucosal semen exposure among healthy women. The study will also monitor~     safety of placebo product use.~   "
37234|NCT02569684|"~     The aim of the study is to compare the effects of prebiotics versus placebo on blood~     concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.~   "
37235|NCT02569671|"~     The aim of this randomized, controlled, multi-center study is to assess the clinical and~     radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate~     implantation following extraction of a tooth in the pre-molar and anterior region of the~     maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites~     (control).~   "
37236|NCT02569658|"~     To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine~     whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of~     transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.~   "
37237|NCT02569645|"~     This study will evaluate whether the addition of Rosuvastatin to standard chemoradiation~     therapy for the treatment of locally advanced rectal cancer may improve the pathological~     response rate and survival compared to standard chemoradiation therapy alone.~   "
37238|NCT02569632|"~     This study will investigate the breadth of protection against meningococcal disease in~     humans immunized with a newly FDA approved meningococcal B vaccine, trade name Trumenba®~     manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate~     underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated~     bactericidal activity.~   "
37239|NCT02569619|"~     The purpose of this study is to determine if a manualised intervention to promote physical~     activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of~     everyday physical activity.~   "
37240|NCT02569606|"~     Comparison of the consumption of blood and coagulation products (packed red blood cells,~     fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates,~     coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics)~     before and after the introduction of a designated trauma related transfusion and coagulation~     algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are~     reviewed. Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital~     Zurich) are included in the study. Predicted probability of a massive transfusion by the~     trauma associated acute hemorrhage score (TASH)is correlated with the actual rate.~   "
37241|NCT02569593|"~     Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to~     participate in a cross-over study using commercial available iron supplements. The aim of~     this study is to evaluate the absorption rate of different oral iron supplements in~     volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).~   "
37242|NCT02569580|"~     The purpose of this study is to determine effectiveness of an Anti-lice treatment using the~     medical device No More which is designed to kill lice and lice eggs on the head.~   "
37243|NCT02569567|"~     The aim of this prospective study was to evaluate the applicability and diagnostic~     performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE)~     for the staging of liver fibrosis using pathologic results as the reference standard.~   "
37244|NCT02569554|"~     The current study will be conducted in healthy adult subjects to evaluate the effect of~     proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the~     bioavailability of the oral solution relative to the tablet formulation of PF-06463922.~   "
37245|NCT02569541|"~     To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic~     antibiotic for the treatment of bone or joint infections.~   "
37246|NCT02569528|"~     The goal of this study is to learn about the patient and provider perceptions, priorities,~     preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy~     in patients with atrial fibrillation. Qualitative interviews will be performed with atrial~     fibrillation patients and providers caring for atrial fibrillation patients. The~     investigators want to understand the factors that influence decision-making about~     anticoagulation medications, and to gain insight into patients' and providers' knowledge of~     the risk of stroke and bleeding associated with oral anticoagulation. This feedback will~     help provide better education to providers caring for patients with atrial fibrillation and~     better care to patients with atrial fibrillation by developing tools to optimize the~     appropriate use of oral anticoagulation for patients with atrial fibrillation.~   "
37247|NCT02569515|"~     This study will evaluate the tolerability, and effect on quality of life, in patients~     receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with~     chronic renal anemia. The anticipated time on study treatment is 10 months, and the target~     sample size is 60 individuals.~   "
37248|NCT02569502|"~     This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with~     advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently~     available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and~     the target sample size is 9 individuals.~   "
37249|NCT02569489|"~     This is a phase I multi-center dose escalation study of the histone deacetylase inhibitor~     (HDACi) HBI-8000 when given in combination with paclitaxel and trastuzumab in women with~     advanced or metastatic HER2+ breast cancer.~   "
37250|NCT02569476|"~     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with~     obinutuzumab in subjects with B-cell lymphoid malignancies.~   "
37251|NCT02569463|"~     The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human~     Interleukin-2 （rhIL-2） for MAS.~   "
37252|NCT02569450|"~     This two arms parallel cluster-randomized trial will evaluate the impact of monitoring~     surgical outcomes using Shewhart control chart (intervention) on the occurence of major~     adverse events, among a large sample of French surgical departments. Trends in surgical~     outcomes before and after the intervention will be compared between arms.~   "
37253|NCT02569437|"~     The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease~     with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients~     may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms~     and avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids.~     Oral steroids are the mainstay of medical management for patients with CRSwNP. However,~     recent studies have shown that doxycycline helps improve symptoms as well by reducing~     inflammation and killing common bacteria that can cause symptoms. This study is the first to~     evaluate this combination regimen.~   "
37254|NCT02569424|"~     There is no recommendation for the management of the positive end-expiratory pressure (PEEP)~     during setting of a central venous catheter (CVC) in a ventilated patient. Several~     non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor~     axis for different pressure levels by evaluating a single vessel every time or by not~     displaying the right or left side in the evaluation. Another study showed that there could~     be unpredictable size differences between the 2 subclavian veins.~      In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous~     return and thus possibly a superior vena cava dilation, located outside the pleura,~     depending on their capacitance. Different pressure levels showed an increase of AST with the~     increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized~     manner.~      The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O)~     and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional~     area of the jugular and subclavian veins.~   "
37255|NCT02569411|"~     The objective of this study is to examine the impact of incentivizing authors of RCTs that~     are eligible for a systematic review and meta-analysis, versus usual contact strategies to~     obtain original IPD~   "
37256|NCT02569398|"~     The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive~     decline compared with placebo treatment, as measured by a composite cognitive measure, the~     Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are~     asymptomatic at risk for developing Alzheimer's dementia.~   "
37257|NCT02569385|"~     The aim of the present study is to determine the cardiovascular function/ cardio respiratory~     interaction on spontaneous breathing trials in patients with prolonged weaning.~   "
37258|NCT02569372|"~     This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the~     Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis~     B Human Immunoglobulin) in Chronic Hepatitis B Patients.~   "
37259|NCT02569359|"~     Recurrent hemarthrosis results in synovitis and destructive arthropathy in hemophilic~     patients. Prophylactic replacement, physical therapy, cyclooxygenase-2 (COX-2) inhibitors,~     corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in~     the managements hemophilic synovitis and arthropathy. In clinical practice, the choice of~     non-steroidal anti-inflammatory drugs (NSAIDs) also needs to take into consideration the~     risk for cardiovascular events and should be used at the lowest effective dose and for the~     shortest duration.This study will investigate the safety and efficacy of Shea nut oil for~     the treatment of hemophilic arthropathy.~   "
37260|NCT02569346|"~     Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®)~     and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to~     as TRI). For patients with swallowing difficulties, administration of whole tablets can be~     problematic and tablets are cut or crushed to ease administration.~      Currently there is no information about crushing TRI tablets. Therefore this study will be~     conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI~     with drip feed are bioequivalent to taking TRI as a whole.~   "
37440|NCT02566980|"~     The goal of the study is to define and measure biological processes that contribute to the~     underlying pathophysiologic process of peri-partum depression to be used for identifying~     those at risk for developing it. This knowledge may also generate novel drug targets for~     peripartum depression that may be applicable to other types of depression.~   "
37261|NCT02569333|"~     Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of~     complications such as infections, venous thrombosis, and surgery. The literature has~     revealed significant variation in the quality of care to hospitalized UC patients. As a~     result, guidelines for the management of these patients have been developed. However, the~     update of guidelines are variable. Admission to hospital can also have significant impact on~     quality of life due to interruptions in life commitments and lost sense of control of~     disease. Maintaining a sense of self-control of disease and active participation in care has~     been shown to be valuable among individuals with chronic diseases. The investigators propose~     the development of a multi-site, patient centred initiative aimed at improving clinical and~     patient-centered outcomes through an educational iPad based tool for patients admitted to~     hospital with ulcerative colitis.~   "
37262|NCT02569320|"~     This pilot phase I trial studies the side effects and best dose of histone deacetylase~     (HDAC) inhibitor AR-42 (AR-42) when given together with pomalidomide in treating patients~     with multiple myeloma that has returned after a period of improvement. HDAC inhibitor AR-42~     may work to stop cancer growth by blocking an enzyme needed for cell growth. Pomalidomide is~     a drug used in chemotherapy that works to stop the growth of cancer cells by causing them to~     die. Giving HDAC inhibitor AR-42 together with pomalidomide may cause patients to respond~     better to treatment.~   "
37263|NCT02569307|"~     This is a randomized double-blind placebo controlled trial which aims to evaluate the~     efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS.~     Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids~     to Treatment as Usual in an operationalized ARMS population in Pakistan:~   "
37264|NCT02569294|"~     This is a clinical non-randomized prospective study. This study had two objectives. The fist~     one was to determine the interest of breast cancer patients in participating in one of three~     group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the~     reasons for choosing a particular group or decline the offer. The second objective was to~     evaluate and compare the benefits of these three interventions on emotional distress, QoL,~     sleep quality and mental adjustment to cancer, at three times after the end of the~     interventions (just after the end, at a 3-month and at a 6-month follow-up).~   "
37265|NCT02569281|"~     Scientific evidence of conservative management of subacromial pain syndrome is conflicting.~     There is evidence that eccentric exercise programs are effective at medium term for this~     pain condition. The inclusion of other therapeutic modalities is still controversial. A~     recent study suggests that the inclusion of US-guided percutaneous electrolysis combined~     with eccentric exercises can be effective at short-term for this condition. The objective of~     this randomized clinical trial is to determine the effectiveness at short- and long-term of~     the inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise~     protocol for the management of patients with subacromial pain syndrome for pain, function,~     disability and pressure pain sensitivity.~   "
37266|NCT02569268|"~     Arteriosclerotic vascular-related diseases have become a serious threat to human health. The~     prevention and reversal of vascular events has become an important direction of medicine.~     Early vascular disease detection system includes pulse wave velocity (PWV), carotid~     intima-media thickness (IMT) and coronary flow velocity reserve (CFVR), flow-mediated~     vasodilation (FMD), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), insulin~     resistance index (HOMA-IR), hypersensitivity C- reactive protein (hs-CRP), plasma~     homocysteine (Hcy), B-type natriuretic peptide (BNP), uric acid (UA), and so on. However,~     there is no international and domestic comprehensive study on simple and practical~     evaluation system by jointing application of these evaluation indexes to detect vascular~     disease. Combined evaluation function can simultaneously detect and evaluate vascular~     abnormalities, make up a single indicator shortcoming in clinical applications from multiple~     levels of vascular structure and function. However, all indicators testing not only cause~     time consuming, but also increase the burden on patients, resulting unnecessary waste of~     medical resources. Thus, the present study was to select appropriate indicators and~     effective joint, and establish the rating system, using the vascular system to predict the~     incidence of terminal events, and compare this system with the previous scoring system such~     as FRS (Framingham Risk Score) pros and cons.~   "
37267|NCT02569255|"~     Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary~     vein isolation (PVI) is still controversial. Experience is reported from consecutive~     patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban,~     or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation.~     All complications possible being related to the use of NOAC are registered.~   "
37268|NCT02569242|"~     The purpose of study is to evaluate the efficacy and safety of ONO-4538 in unresectable~     advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.~   "
37269|NCT02569229|"~     The aim is to describe the association of glucose tolerance measured with three different~     tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT~     and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung~     function and anthropometric parameters in patients with cystic fibrosis.~   "
37270|NCT02569216|"~     An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart~     pacemaker delivers a weak electrical current to the human uterus during active preterm labor~     to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a~     preterm birth.~   "
37271|NCT02569203|"~     To determine whether high-protein (24% of total calorie from protein) enteral nutrition of~     immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan~     stimulates immune functions compared with standard enteral nutrition (control: 20% of total~     calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition~     of immune modulating nutrients without β-glucan in critically ill patients.~   "
37272|NCT02569190|"~     Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in~     hemiplegia patients.~   "
37441|NCT02566967|"~     This study will evaluate the optimal dose of tofacitinib needed to achieve low disease~     activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical~     remission has been achieved, the structural benefit in reducing erosions, synovitis and bone~     edema as measured by low field MRI will be determined at the same time period by the use of~     the OMERACT/RAMRIS scoring system~   "
37273|NCT02569177|"~     Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15%~     of patients undergoing cardiac surgery and is associated with an increased length of stay,~     and reduced short- and long-term survival. Cardiac troponin is considered to be a~     cornerstone in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding~     Protein (H-FABP) is a new sensitive biomarker for myocardial injury. The effectiveness of~     using the combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours~     after the onset of ischemia is well reported. Previous studies in non-surgical patients have~     associated increased H-FABP with an increased risk of subsequent death and major cardiac~     events. The prognostic value in cardiac surgery patients has not been studied extensively.~      The objective is to estimate the association between biomarkers of myocardial injury and~     myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be~     established with both a new and very early marker of myocardial injury (Heart-type Fatty~     Acid Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).~   "
37274|NCT02569164|"~     PCO patients will be assessed clinically,urine & blood samples will be tested. Systolic &~     diastolic blood pressure, serum glucose & insulin levels, lipid profile, C-reactive protein,~     complete hormonal profile, and Urinary albumin excretion will be measured.~   "
37275|NCT02569151|"~     Participants were examined using the methods reported previous. All chemical laboratory data~     were obtained at each clinic visit in the morning in a non-fasting state. A single specimen~     at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the~     ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning~     within 10 minutes after awakening in the sitting position, but HBP value assessed for this~     study used the value measured once in the same morning at each clinic visit.~      Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130~     mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension~     (MN) were defined as SBP <130 mmHg and DBP <85 mmHg, respectively. The reason underlying~     that same threshold was used for both clinic and morning values was based on criteria of the~     1999 WHO-International Society of Hypertension guidelines, because this study started in~     1999. Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive~     drug use was determined in each group. In addition, based on CBP, subjects were divided into~     CH and CN patients. These patients were followed using the same methods used for MH and MN~     patients.~      Outcome considered only the first event in each subject. Primary end-point was death from~     any cause. Secondary end-points were new, worsened, or improved microvascular and~     macrovascular events.~      Risk factors related to each outcome were determined, and therapy which was added to~     baseline used for each disease in patients with MH was recorded at base- and end-points.~      All results are presented as means ± SD. Mean values were compared using the paired or~     unpaired student t test. To compare the prevalence of events or medical treatment in~     patients with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P~     values was used, and then hazard ratio and 95% confidence intervals were calculated.~      Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and~     end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier~     survival curves and then compared by hazard rate using the log-rank test.~      Risk factors determined to be statistically related to outcomes were assessed by Cox~     proportional hazard analysis.~   "
37276|NCT02569138|"~     The purpose of this study is to investigate the long term balance-enhancing effects of~     insoles that are hard and thin for older adults. Thirty older female adults between the ages~     of 65-84 years will be recruited for this study. Twenty participants (20) will wear the~     experimental insole and ten (10) participants will work their usual insole, during a 12 week~     period. Balance and foot sensitivity testing will take place at 0, 6 and 12 weeks. These~     tests will involve measurement of body motion and foot pressure in order to evaluate balance~     control. Additionally, each participant will be asked to return a bi-weekly postcard that~     will report on footwear wearing patterns and any falls (or fall-related) incidents that have~     occurred during the 12 weeks.~   "
37277|NCT02569125|"~     This is an open-label, multicenter, single-arm, phase II clinical trial of Everolimus~     (RAD001) in patients with segmental overgrowth syndrome.~   "
37278|NCT02569112|"~     The purpose of this study is to evaluate the effect on the subject outcome using the~     combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar~     radiofrequency device with varipulse technology for the enhanced non-surgical treatment of~     skin laxity in the flank area.~   "
37279|NCT02569099|"~     The burden of stroke has continued to increase in Zimbabwe in the last 3 decades. resulting~     in increased burden of care to family caregivers. Caregivers who had cared for survivors for~     periods exceeding 3 months indicated desire to be taught about basic care before they were~     discharged from hospital and a curriculum of training based on a targeted needs analysis was~     developed. One arm of the study will receive caregivers training as the intervention and the~     other arm will be the control. The outcome of both the caregivers and survivors will be~     compared based on selected tools. Data will be collected at baseline (at most 2 weeks after~     suffering a stroke) the participants will be followed up at 3 and 12 months post stroke.~   "
37280|NCT02569086|"~     Antibiotic dosing in severe septic patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      The investigators aim is to determined the pharmacokinetic profile of piperacillin 4g every~     8 hour in 20 patients treated empirically for severe sepsis. A PK population model will be~     established with the dual purpose to assess current standard treatment and to simulate~     alternative dosing regimens and modes of administration. Time above the minimal inhibitory~     concentration (T>MIC) predicted for each patient will be evaluated against MIC for pathogens~     detected. Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated are 100% f T>MIC and 50%~     fT>4xMIC.~      Only patients who are prescribed piperacillin empirically by the treating physician are~     enrolled in the study. The investigators have no influence on the choice of treatment~     prescribed to the patient.~   "
37281|NCT02569073|"~     In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest~     Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were~     not adversely affected by this regiment. In fact, some cholesterol measures trended in a~     favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol~     twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to~     see if the same goals can be achieved. More so, the study will be extended to 12 weeks to~     gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that~     reducing the dose and extending the duration will continue to show an improvement in~     symptoms as well as no adverse metabolic outcomes.~   "
37282|NCT02569060|"~     The Feeding America Intervention Trial for Health—Diabetes Mellitus (FAITH-DM) is a~     randomized, controlled study of the implementation of a diabetes intervention in food pantry~     settings.~   "
39950|NCT02534064|"~     The purpose of this study is to evaluate the effect of daily consumption of one or two~     CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of~     the serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.~   "
37283|NCT02569047|"~     The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial~     is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART)~     restorations compared to the Hall Technique (HT) placed in a school setting. The~     investigators will recruit 120 schoolchildren (6-8 years) with at least one~     occlusal-proximal carious lesion in primary molar. They will be randomized and treated~     following best-practice protocols to either receive an ART restoration using the~     high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal~     crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I~     Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year~     period) will be assessed through participant report, clinical examination and parent report/~     questionnaires.~   "
37284|NCT02569034|"~     Anhedonia, decreased motivation for and sensitivity to rewarding experiences, is present in~     at least 1/3 of community dwelling older adults and is a feature of various psychiatric and~     neurological disorders, including late-life depression and Parkinson's disease. Anhedonia is~     associated with cognitive deficits, as well as poor clinical outcomes and increased~     mortality. Recent research suggests that anhedonia comprises motivational (reward wanting)~     and consummatory (reward liking) aspects. However, previous research on anhedonia has~     failed to dissociate these components, which may explain the contradictory findings in the~     literature. Recently, the Effort-Expenditure for Rewards Task (EEfRT) was developed in an~     effort to dissociate reward components in anhedonia. The EEfRT is an effort-based~     decision-making task that measures reward wanting, in contrast to commonly used anhedonia~     questionnaires, which focus on reward liking. This novel task may provide a useful measure~     of components of anhedonia in older adults and in different patient populations. Thus far no~     data is available on this task in elderly individuals, and the cognitive and neural~     correlates of components of the task have not been investigated. Given the paucity of~     research on the neurobiology of anhedonia, cognitive neuroscience studies using this task~     could fill a gap in the literature. The investigators are developing a line of cognitive~     neuroscience studies examining anhedonia in community-dwelling older adults and in late-life~     depression and Parkinson's disease. This study will involve gathering pilot behavioral and~     functional magnetic resonance imaging (fMRI) data in young and older adults performing the~     EEfRT task. Understanding the brain mechanisms underlying anhedonia in older adults and in~     different patient populations will have a translational impact by elucidating biological~     targets for treatment.~   "
37285|NCT02569021|"~     The purpose of this research study is to test effectiveness of different deep brain~     stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the~     battery. If these patterns are effective, the implanted batteries will be drained more~     slowly and last longer than currently expected. An increase in battery life may reduce the~     number of surgeries needed to replace them.~   "
37286|NCT02569008|"~     This study evaluate the effect of different doses of crystalloids on the changes on cardiac~     output (CO) and on the proportion of responders and non-responders and aims to determine the~     minimal volume required to increase the mean systemic filling pressures (Pmsf) in~     post-cardiac surgical patients.~   "
37287|NCT02568995|"~     Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality~     after hip joint replacement is low but some complications remain, including chronic~     post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4).~     Strategies that have been identified to reduce morbidity and mortality include: posterior~     surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and~     the use of spinal anesthesia (5). One of the important factors for patient satisfaction with~     lower limb arthroplasty is good postoperative pain management (6). Poorly managed~     postoperative pain can lead to chronic post-surgical pain and therefore aggressive~     postoperative pain management is important (7). Several different methods have been used to~     treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a~     combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory~     agents (NSAID) injected systematically peri-articularly has been used for pain management~     with variable success (8). We found that better analgesia could be achieved when using LIA~     compared to intrathecal morphine during the first few days postoperatively (9,10).~      Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to~     reduce pain intensity and may be considered by many to be a standard of care. Specifically,~     the 3-in-1 block has been commonly used because of its ease of application and good pain~     management following total hip arthroplasty. The present study aims to compare postoperative~     pain intensity following local infiltration analgesia with a standardised 3-in-1 block for~     total hip arthroplasty.~   "
37288|NCT02568982|"~     This study aims at investigating the complications of Cushing's disease in de novo~     patients. A series of investigations will assay before treatment and every year thereafter~     during a 3 years follow-up period the various complications of the disease. These~     investigations will determine the presence and severity of cardiovascular, metabolic, and~     bone complications as well as the Quality of Life. Outcome of these complications after~     treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.~   "
37289|NCT02568969|"~     The major combined interventions are between challenging and high-risk aspects of current~     cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and~     technical features influencing the surgical approach as well as cardiopulmonary bypass~     (CPB), anesthesia, and respiratory support.~      Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage,~     and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the~     discrete measurement of these values among with other biochemical values has a major~     drawback and continuous measurement can be beneficial.~      The aim of our study is to assess the clinical usefulness and rationale for routine use of~     continuous monitoring of lactate in high-risk combined/complex cardiac surgery.~   "
37290|NCT02568943|"~     The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or~     relapsed and refractory multiple myeloma patients who are without satisfactory treatment~     alternatives prior to the commercial availability* and reimbursement of panobinostat during~     the regulatory approval process. This protocol will acquire additional safety data on the~     use of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients~     with relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be~     administered in the defined regimen in combination with both BTZ and DEX.~      *(Note: throughout this protocol commercially available means local health authority~     approval and a functional method for reimbursement)~   "
37291|NCT02568930|"~     The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in~     older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation~     (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination~     therapy [DT]) and their caregivers. Our study will contribute to better patient-centered~     care of older advanced HF patients and their caregivers, by informing decision making and~     guiding strategies to enhance post-operative HRQOL.~   "
37292|NCT02568917|"~     Background: Dental caries is still a public health problem among Brazilian children and~     doubts still exist regarding the most effective restorative technique. The aim of this~     pragmatic randomized clinical trial is to evaluate the effectiveness of single and~     multiple-surfaces restorations performed following the Atraumatic Restorative Treatment~     (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.~      Methods: A total of 1,214 5-to-13 years-old children with at least one single or~     multiple-surface dentin caries lesion in primary or permanent molars will be selected in the~     public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT~     (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained~     dentists in a dental office inside the schools. The restorations will be evaluated after 6,~     12 and 24 months by an independent trained and calibrated examiner. The restoration and~     tooth survival, the cost-effectiveness analysis between the two groups and the operator~     preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier~     survival analysis and log-rank test will be applied to the survival of restorations. All the~     average event rates in the two groups will be modelled and compared with a Cox proportional~     hazard shared frailty model since there is an operator cluster-effect. The significance~     level for all analyses will be 5%.~   "
37293|NCT02568904|"~     Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to~     inflammation and immune dysfunction as well as the typical hangover symptoms. Probiotics are~     able to restore gut permeability and decrease bacterial translocation. A multispecies~     probiotic may be able to restore gut permeability and decrease bacterial translocation as~     well as inflammation, immune dysfunction and hangover symptoms after alcohol consumption.~      Specifically, gut permeability, bacterial translocation, inflammation, immune dysfunction~     and hangover symptoms in patients after alcohol ingestion +/- ingestion of a multispecies~     probiotic~   "
37294|NCT02568891|"~     In end-stage renal disease (ESRD) cardiovascular and infectious complications are common.~     The gut microbiome might play an important pathophysiological role. ESRD is hypothesized to~     be associated with profound alterations of gut microbiome and gut permeability. The~     investigators aim to test whether a multispecies probiotic mixture is able to revert the~     microbiome changes and decrease gut permeability. Furthermore the investigators aim to test~     whether this improvement in microbiome composition and gut permeability is also associated~     with improvements in endotoxemia, uremia and cardiovascular risk factors.~   "
37295|NCT02568878|"~     -  Assess the antidepressant/anxiolytic effect of creatine in male and female~          methamphetamine users~        -  Assess creatine's effect on methamphetamine use~        -  Assess the safety of creatine in male methamphetamine users with depression~   "
37296|NCT02568865|"~     This project aims to use sensors to monitor physiological signals, sleep patterns, vocal~     characteristics, activity, location and phone usage in study patients with depression who~     are receiving standard treatment (compared with healthy controls).~   "
37297|NCT02568852|"~     Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of~     pneumoperitoneum on coagulation factors is not well known. In our study the investigators~     aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA)~     during laparoscopic cholecystectomy(LC) with effect on coagulation factors.~      Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under~     Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia~     (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.~   "
37298|NCT02568839|"~     The purpose of this trial is to evaluate efficacy and toxicity of either the combination of~     docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of~     therapy to the opposite treatment alternative is applicable in case of lack of response~     after two courses of treatment, or for medical reasons under exceptional circumstances (drug~     reaction, other medical conditions) at any point. After termination of the primary treatment~     follow-up for five years.~      A translational subprotocol is a mandatory part of the study protocol, with exception for~     the use of PET-CT evaluations.~   "
37299|NCT02568826|"~     This is a prospective cohort study, open-label, uncontrolled proof of concept trial. The~     trial objective is to evaluate the analgesic tolerability, safety and activity of IDN 5243~     (3-glycosyl-3-O-demethylthiocolchicine derivative)administered intramuscularly at 4 mg~     b.i.d. for 5 days in the morning (8.00-10.00 AM) and in the evening (6.00-8.00 PM) in~     subjects with Low Back Pain (LBP).~   "
37300|NCT02568813|"~     Epilepsy is a multifaceted disorder and a major public health problem. In addition to~     recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and~     social-adaptive behaviors are potential major sources of disability in children and adults~     with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric~     comorbidities in children with epilepsy, particularly emotional regulation disorders such as~     depression and anxiety, as compared to both the general population and the children with~     other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has~     been reported, compared to 3-8% in the general population.~      Major advances have begun to uncover the potential mediators of emotional regulation~     disorders and social comorbidities in epilepsy, but important gaps remain in the early~     detection, treatment and prevention of these disorders. A very small number of~     investigations have examined children with epilepsy at or near the time of diagnosis. This~     is a time during which the effects of chronic epilepsy, potential averse social effects of~     epilepsy, and other complicating aetiological effects are minimized.~      Epilepsy syndromes provide a useful framework for considering the risk and type of emotional~     dysregulation comorbidities. But variability within and across syndromes needs to be taken~     into account thus requiring a strict phenotyping by specialists in the filed of pediatric~     epileptology. Retrospective studies, usually including patients with chronic epilepsies and~     suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather~     disparate findings.~      Are such disorders the result of common physiopathological mechanisms, which precede the~     development of the epilepsy? The link between an underlying brain disorder and psychiatric~     comorbidities has emerged in recent literature, with evidence based on studies in adults,~     suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities.~     Emotional regulation disorders can follow the onset of epilepsy, but they can also precede~     it, thus serving as a possible risk factor. The clinical implication of such a bidirectional~     association is that neurobehavioural comorbidities might be present at diagnosis and even~     before epilepsy onset. There is a need for greater understanding of the causes of these~     conditions in younger people.~      The degree to which specific epilepsy syndromes are associated with the relative risk of~     emotional dysregulation disorders in children with new- or recent-onset (within six months~     prior to enrolment) has rarely been comprehensively examined and represents the focus of the~     current investigation.~      The investigators study will be based on a prospectively recruited cohort of 280~     children/adolescents with recently diagnosed epilepsy. All participating centres dispose of~     the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools~     for a per case appropriate aetiology screening. Following a first seizure children are~     usually first examined at hospital based emergency departments. Prompt referral to the~     epilepsy teams participating at the present study will significantly reduce the population~     biases and shortcuts encountered in studies that recruited patients with chronic epilepsy~     followed in tertiary care epilepsy units.~      The investigators expect their results to provide a greater understanding of both the shared~     and the unique features of emotional regulation disorders, in relation to specific epilepsy~     categories defined on the basis of the underlying physiopathological mechanisms.~      Such knowledge will also assist clinicians and families in the planning of both diagnosis~     and management resources.~   "
37301|NCT02568800|"~     It is advocated that prolonged infusion of beta-lactamic antibiotics provides better~     bactericidal effect. The aim of the present study is to randomize patients a to extended~     cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting~     more than thirty minutes) and evaluate the clinical efficacy of this theoretical~     pharmacokinetic advantage.~   "
37302|NCT02568787|"~     The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound~     (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This~     nutritional supplement is made from a water soluble extract of rice bran that has been~     partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake~     mushroom.~   "
37303|NCT02568774|"~     This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms.~     Participants will be put into groups randomly and compared. There are three groups:~     traditional acupuncture, placebo acupuncture and usual care. The ratio of group allocation~     is 1:1:1.~   "
37304|NCT02568761|"~     A randomized single blind clinical trial, with a larger sample size than previous studies ,~     to evaluate the effectiveness of injection snoreplasty in the treatment of patients with~     snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal~     exercises, a low cost therapeutic modality.~   "
37460|NCT02566720|"~     This is a pilot study. The objective is to further understand the mechanism by which~     amantadine improves function in patients with persistent vegetative state and minimally~     conscious state. Specifically, the investigators will measure the size of the nerve fibers~     that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI~     tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score.~     The information gathered from this study will be used to formulate a larger clinical trial.~   "
37305|NCT02568748|"~     Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the~     third most common cause of cancer-related deaths complicating liver cirrhosis in most cases.~     In Egypt, there has been a remarkable increase of the proportion of HCC among CLD patients~     from 4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing~     risk factors such as the emergence of HCV over the same period of time, the contribution of~     HBV infection, improvement of the screening programs and diagnostic tools of HCC as well as~     the increased survival rate among patients with cirrhosis to allow time for some of them to~     develop HCC. The only curative treatment modalities for HCC are surgery, local ablation, and~     liver transplantation which have high recurrence rate either due to viral hepatitis~     infection or cirrhosis leading to low success rate and high economic burden.~      Unfortunately, the majority of patients have unresectable disease at diagnosis. So, patients~     search for palliative very expensive therapies including chemotherapy and radiotherapy which~     often fail to eradicate tumor lesions completely and tend to result in many adverse~     events.Thus, novel approaches for treatment options are needed for patients with advanced~     HCC .~      In recent years, immunotherapy has emerged as an efficacious treatment modality with~     encouraging efficacy and slight adverse events in cancer therapy [Stroncek 2010].~     Cytokine-induced killer CIK cells therapy has been evaluated as an adoptive cell~     immunotherapy for cancer patients in a number of clinical trials and the promising efficacy~     of CIK cells on malignancies has been proved.~   "
37306|NCT02568735|"~     The main purpose of this study was to determine the plasma and central nervious system~     pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their~     effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory~     markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate~     their efficacy in postoperative pain treatment.~   "
37307|NCT02568722|"~     The objectives of this trial are to determine whether, in critically ill patients with~     severe acute kidney injury (AKI), randomization to accelerated initiation of renal~     replacement therapy (RRT), compared to standard initiation, leads to:~        1. Improved survival (primary outcome); and~        2. Recovery of kidney function (principal secondary outcome), defined as independence from~          RRT at 90 days~   "
37308|NCT02568709|"~     The specific aim of this proposal is to investigate the neurophysiological mechanisms of~     oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using~     magnetoencephalography.~      Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala~     hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity~     will be normalized.~      Hypothesis B: When OT is administered to patients with schizophrenia, the decreased~     functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.~      By elucidating the neurophysiological mechanisms of OT administration on emotional face~     processing, investigators will bee able to:~        1. understand the pathophysiology of the functionally debilitating social cognitive~          deficits of schizophrenia,~        2. test the efficacy of OT in normalizing the neural abnormalities underlying these social~          deficits, and~        3. develop and optimize novel treatments for these currently untreatable deficits.~   "
37309|NCT02568696|"~     The purpose of this study is to investigate local activation of the coagulation system in~     the kidney graft during organ preservation and during early reperfusion in adult kidney~     transplantation. Generation of thrombin and fibrin as well as activation and inhibition of~     fibrinolysis will be investigated. Influence of these events on delayed graft function (DGF)~     and acute cell-mediated rejection will be evaluated.~   "
37310|NCT02568683|"~     This study will evaluate the safety of entospletinib (ENTO) with vincristine (VCR) in~     participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL).~   "
37311|NCT02568670|"~     This is a single-center, open label, prospective, randomized, noninferiority controlled~     trial with cost-effectiveness analysis to verify if is non inferior to remove peripheral~     intravenous catheter according to clinical signs in relation to every 96 hours.~   "
37312|NCT02568657|"~     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide~     reaching as high as 60% in some countries.~      Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre~     or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should~     be considered a PPH.~      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to~     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH~     due to uterine atony. This recommendation is now stronger than the previous guidelines. It~     can be used for women who do not respond to uterotonics or if uterotonics are not available.~     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a~     higher-level facility.Furthermore, FIGO included Uterine balloon tamponade as a recommended~     second-line intervention for the treatment of PPH in their updated guidelines issued in~     2012.~      In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and~     Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored~     design that enables conservative management of uterine bleeding in cases of uterine atony~     and other causes of PPH.~      The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a~     wide variety of causes in resource-poor settings.~      One of the new methods that could be used to control PPH is Uterine packing with~     chitosan-covered gauze or Celox.~      Celox Haemostats are dressings with natural material called chitosan to control major~     haemorrhage including life-threatening bleeding . They are simple and effective, stopping~     major bleeding.It was first used by military forces to stop sever bleeding in the scene with~     no other options to stop bleeding. Celox™ granules are actually very high surface area~     flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to~     make a gel like clot, without generating any heat. Celox™ does not set off the normal~     clotting cascade, it only clots the blood it comes directly into contact with. Celox works~     on casualties using anticoagulants and anti-platelet therapy such as aspirin .~   "
37313|NCT02568644|"~     The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen~     for the treatment of headache and other symptoms related with migraine attacks.~   "
37343|NCT02568241|"~     This study aimed to evaluate the efficacy of interferon α after prophylactic donor~     lymphocyte infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated~     blood and marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an~     effective treatment option for high-risk acute leukemia (AL). However, post-transplant~     relapse can occur in some patients, and the prognosis of these patients is usually very~     poor.Prophylactic DLI can decrease the risk of relapse of high-risk AL patients. Interferon~     α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating~     T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential~     value for high-risk AL patients after transplantation. The study hypothesis: Using~     interferon α-2b after prophylactic DLI following hematopoietic stem cell transplantation in~     patients with high-risk AL can further reduce relapse rate and improve leukemia-free~     survival.~   "
37314|NCT02568631|"~     The serious game JeStiMulE (Educational Game for Multisensory Stimulation of Children with~     developmental disorders), developed by the Autism Resources Center of Nice, was created to~     teach social cognition including emotion recognition in context, for children and~     adolescents with autism. In a previous study, JeStiMulE has demonstrated efficacy in a~     population of young people aged 6-17 years old with high and low levels of autism.~      According to the recommendations of the 2011 HAS, disorders of social interactions are the~     most persistent troubles of the autistic triad in life.~      It seems essential to us to be able to offer young adults with autism, rehabilitation~     methods adapted to their trouble, and to observe whether JeStiMulE could be one of them.~      This study researches the effectiveness of the serious game JeStiMulE in the improvement~     social cognition for adults with autism versus controls.~      The main goal is:~      - Comparing the improvement in social cognition among adults with autism using the serious~     game JeStiMulE or not.~      Two groups will be formed: a first one of fifteen adults with a diagnosis of autism~     objectified, this group will use JeStiMulE and will be compared to a control group of adults~     with autism, using another video game, not aimed to improve social cognition.~      The objective of JeStiMulE players will be ending the game after a learning period and two~     playing periods (with emotional words and idioms, including three modules each). The groups~     will be matched with their nonverbal IQ through Raven matrices and visual memory tasks~     (WAIS).~      The control group will also be stimulated through a video game, not specialized in improving~     social cognition.~      The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test:~     by the number of emotions recognized on faces, compared to the number of emotion presented~     through this test.~      The secondary outcomes will be:~        -  The rest of social cognition improvement by several tests (the theory of mind with the~          score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a~          self-administered questionnaire: EQ / AQ).~        -  The impact on the quality of life, verbal fluency of emotional words, and the feedback~          from JeStiMulE players will also be seen as a secondary outcome.~   "
37315|NCT02568618|"~     This study utilizes the Medication DNA Insight™ tests for pain and mental health~     medications. We are testing the pain and mental health medications commonly used in pain~     treatment. Subjects will give a sample of saliva that will be tested for the metabolism of~     the different medications. Consented providers will be given the results of the test and can~     determine whether to change the subject's medication regimen. Providers and subjects will be~     ask to complete surveys both pre and post visits. The purpose is to examine provider and~     patient satisfaction, confidence and certainty of using the test results.~   "
37316|NCT02568605|"~     Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the~     liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD.~     Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic~     fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota;~     therefore they may have potential as part of a dietary strategy for NAFLD treatment.~   "
37317|NCT02568592|"~     The capacity to burn fat as fuel for exercise may have important implications for sporting~     performance, with dietary fat intake positively influencing this ability.~      Endurance performance and the ability to burn fat will be measured in women runners~     following the consumption of 3 diets varying in the amount of fat and carbohydrate.~   "
37318|NCT02568579|"~     This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%)~     breast fed and 40 infants that are exclusively formula fed for at least the first 4 months~     of life from birth until 12 month age. Visits - Subjects will be consented prior to~     delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool~     collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age~     post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will~     contact via phone/email to collect information about feeding changes.~   "
37319|NCT02568566|"~     This phase IIA trial studies how well a recombinant human papillomavirus nonavalent works in~     preventing human papilloma virus (HPV) in younger healthy participants. HPV is a common~     virus which usually causes infections that last only a few months, but sometimes can last a~     long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years~     among adults. Recombinant human papillomavirus nonavalent vaccine is a type of nonavalent~     vaccine (a vaccine that works against nine different viruses or other microorganisms) and~     may protect against HPV infection and the health problems that HPV infection can cause.~   "
37320|NCT02568553|"~     This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab~     when given together in treating patients with non-Hodgkin lymphoma that has returned after a~     period of improvement. Biological therapies, such as lenalidomide and blinatumomab, use~     substances made from living organisms that may stimulate or suppress the immune system in~     different ways and stop cancer cells from growing.~   "
37321|NCT02568540|"~     Today's mobile devices (especially smartphones) are powerful ways to communicate new~     information to medical researchers. For this study, researchers at Boston Children's~     Hospital are asking people with hepatitis C to make use of their smartphones to help report~     information about themselves that may improve how hepatitis C is treated. This study uses a~     free app called C Tracker that can be installed from the Apple App Store onto the~     participants iPhone. The main goal of this research study is to use this app to report~     hepatitis C related health information to the researchers who are conducting this study. The~     investigators will ask participants about their health,activities, medications, and ways in~     which hepatitis C has impacted you. This information will be reported anonymously, which~     means that the researchers doing the study won't know who the participants are.~   "
37322|NCT02568527|"~     The purpose of this clinical study is to undertake a pilot safety and efficacy study of a~     synthetic biodegradable membrane as a substitute for using donor human amniotic membrane~     (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly~     excised limbal tissue in theatre as a one stage procedure~   "
37323|NCT02568514|"~     In this study, the investigators will conduct a randomized, controlled trial to evaluate the~     impact of offering mobile secure text messaging on clinical outcomes.~   "
37324|NCT02568501|"~     In this study the investigators will compare a novel approach using daily financial~     incentives and a tiered sponsor network to motivate adolescents and young adults with type 1~     diabetes to improve glycemic control.~   "
37355|NCT02568085|"~     This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista~     hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing~     drainage output after total thyroidectomy with and without lateral neck dissections.~     Increased drainage in total thyroidectomy and neck dissection wound beds can lead to seroma~     formation with possible secondary infection, delayed hospital discharge, and additional home~     care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic~     powder that can be easily applied to broad surgical fields to reduce bleeding and seroma~     rates. Therefore, its application to thyroidectomy and neck dissection wound beds may bear~     significant potential benefit.~   "
37325|NCT02568488|"~     Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three~     criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The~     criteria were as follows:~        1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles~          per year or amenorrhoea (cycle length > 12wks),~        2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels~        3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than~          eight follicles in an ovary ranging from 2-10mm).~      the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months.~     Blood samples were collected at the start of the study, before receiving metformin, where~     baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG)~     , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian~     Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and~     6 months respectively of metformin treatment , to asses its effect on serum levels of the~     previously mentioned hormonal parameters.~   "
37326|NCT02568475|"~     This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of~     interest related to development of decision support tools that bring patients, families and~     clinicians together to decide, in this instance, whether or not transfer from the nursing~     home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to~     develop an evidence-based decision aid addressing potentially avoidable transfers of~     residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this~     decision aid in terms of acceptability to residents and families and its effect on the~     quality of transfer decisions.~      The primary hypotheses to be tested are:~      Hypothesis 1: Resident and family members in the intervention group will report greater~     preparation for decision making and less decisional conflict than those in the no treatment~     control group.~      Hypothesis 2: Residents and family members in the intervention group will demonstrate~     increased knowledge related to acute care transfer and less preference for acute care~     transfer than those in the no treatment control group.~   "
37327|NCT02568462|"~     The purpose of this study is to evaluate the safety and performance of a new version of a~     coronary artery stent for treating blockages in the arteries supplying blood to the heart~     muscle. The Amaranth Medical APTITUDE scaffold releases a drug (sirolimus) to reduce the~     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold~     dissolves away over time, leaving no permanent implant after the blood vessel has healed.~   "
37328|NCT02568449|"~     This phase II trial studies how well nintedanib works in treating patients with malignant~     pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
37329|NCT02568436|"~     26 participants from the Orthodontic Department at University of Damascus Dental School will~     be randomly assigned into two groups. In the experimental group, a low level laser with a~     wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15~     seconds per point will be applied on each tooth of the six upper incisors according to this~     protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be~     applied in the center of each half from both the buccal and palatal sides which means 4~     application points and a total energy of 8 j per each tooth. Control group will undergo~     typical orthodontic treatment with the laser device applied the same manner but without~     being turned on (to get the placebo effect for pain reduction effect). This procedure will~     be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till~     the end of the leveling and alignment stage.~   "
37330|NCT02568423|"~     The main purpose of this study is to explore the safety and tolerability of LY3074828 in~     healthy Japanese and Caucasian participants. The study will also estimate how much LY3074828~     gets into the blood stream and how long it takes the body to remove it. The study is~     expected to last about 16 weeks for each participant.~   "
37331|NCT02568410|"~     Platelets are increasingly recognized as a potent and ubiquitously present source of~     inflammatory activation. Importantly, antiplatelet therapy has been shown to significantly~     reduce major adverse events such as renal injury in cardiac surgery patients. However, in~     current practice, concerns of excessive bleeding—not platelet activation and~     thrombosis—shape clinical decisions.~      The investigators have recently seen, that a significant drop in platelet numbers following~     cardiac surgery is associated with increased mortality and risk of acute kidney injury. The~     investigators hypothesize that such thrombocytopenia is a result of excessive perioperative~     platelet activation and resultant release of inflammatory and tissue injurious signals by~     activated platelets. Platelet activation will be characterized during and after cardiac~     surgery and examine its correlation with inflammatory responses and perioperative end-organ~     injury.~   "
37332|NCT02568397|"~     The purpose of this study is to learn about the effect of AZD3293 on how the body absorbs~     and processes dabigatran etexilate and how dabigatran etexilate affects AZD3293 when they~     are taken together. This study will last about 28 days and participants will be asked to~     take an AZD3293 tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions.~     Screening is required within 30 days prior to the start of the study.~   "
37333|NCT02568371|"~     The bio-Share project aims at collecting blood samples in students participating in the~     i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable~     investigators in the future to study biological determinants of conditions that affect young~     adults and to test certain hypotheses on the pathophysiology and mechanisms underlying~     diseases occurring both at a young age and later in life (as early exposures may also impact~     late onset diseases)~   "
37334|NCT02568358|"~     Lung transplantation (LTx) , DNA-based testing.~      Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard~     testing.~      Experimental intervention: DNA-based testing of BAL fluid.~   "
37335|NCT02568345|"~     The purpose of this study is to determine the minimum effective dose of sugammadex, an~     antagonist of neuromuscular blockade used during anesthesia practice, in obese patients,~     considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg~     but no studies were found with obese patients.~   "
37336|NCT02568332|"~     This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines~     AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV)~     seropositive individuals. This study also aims to assess the cellular immune response~     generated by these vaccines when administered as mentioned above.~   "
37344|NCT02568228|"~     Intake of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) from fish oil and fish are~     associated with significant health benefits in risk of cardiovascular disease. However, both~     lean and fatty fish have been shown to have beneficial effects suggesting that not all~     effects are mediated by n-3 PUFAs. Krill oil is an n-3 PUFA supplement on the marked. The~     n-3 PUFAs from krill oil is in the form of phospholipids, and these fatty acids may be more~     readily and effectively absorbed after ingestion than n-3 PUFAs in the form of~     triacylglycerols from fish oil. Fish also contain many other potential health components~     than n-3 PUFAs such as taurine and vitamin D, iodine, selenium and more unspecified~     components such as bioactive peptides which can mediate the health beneficial effects~     observed after intake of fish.~      The present study aims to elucidate the cardiovascular health beneficial effects after~     consumption of fish (lean and fatty) and krill oil, with regard to effects on plasma lipids~     and other markers of cardiovascular health such as inflammatory, haemostatic and endothelial~     dysfunction markers. The investigators will perform whole genome transcriptome analyses in~     peripheral blood mononuclear cells (PBMCs) in order to further understand the cardiovascular~     health benefits and elucidate the mechanisms of action.~   "
37345|NCT02568215|"~     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)~     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected~     women.~   "
37346|NCT02568202|"~     This study is conducted in the United States of America (USA). Tha aim of this study is~     bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).~   "
37347|NCT02568189|"~     Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the~     inferior vena cava impacts the management and outcomes of pediatric emergency department~     patients undergoing evaluation and treatment of sepsis and gastroenteritis associated~     dehydration.~   "
37348|NCT02568176|"~     The primary purpose of this study is to evaluate the induction potential of repeated~     administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in~     healthy participants using orally administered midazolam and bupropion as probes,~     respectively and to evaluate the pharmacokinetics of esketamine after a single dose and~     repeated administration.~   "
37349|NCT02568163|"~     Treatment of periodontal diseases is influenced by several risk factors. Psychological~     stress is considered as one of them. Aim of this study is to assess if stress influences~     results of non surgical periodontal treatment in severe chronic forms of periodontitis.~   "
37350|NCT02568150|"~     Evaluate onset time and safety of improvement effect of each group's forehead wrinkles after~     2, 3, 4, 5, 14 days from administration of 20U dosage of DWP450-004 for adult patients who~     need more than moderate improvement of forehead wrinkles.~   "
37351|NCT02568137|"~     This research seeks to develop a culturally-acceptable, effective, and sustainable way of~     utilizing the rapidly growing penetration of mobile phones among people in Sub-Saharan~     Africa (SSA), to improve the currently poor control of hypertension among patients at high~     risk for future stroke. It also aims to develop human capital in SSA to conduct~     locally-relevant, high-quality stroke research in the future. Specifically, this study will~     preliminarily test a strategy that incorporates mobile phone texting and home blood pressure~     monitoring directed by trained nurses, to improve patient adherence to proven medical~     therapies for treating hypertension.~   "
37352|NCT02568124|"~     BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial~     neurosurgical consult. There is no widely accepted medical treatment for CSDH.~      This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH~     resolution following conservative management, lower the number of required surgical~     procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is~     a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to~     provide preliminary efficacy data as well as feasibility, safety and incidence data required~     to plan a larger definitive phase III trial.~      METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de~     Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component~     will be screened for eligibility. Exclusion criteria include specific risk factors for~     thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130~     patients will be randomized to receive either 750 mg of TXA daily or placebo until complete~     radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be~     measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as~     well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up~     and 3 months post-treatment follow-up. During the treatment period, patients will undergo~     standard CSDH management with surgery being performed at the discretion of the treating~     physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in~     vitro analysis.~      The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned~     surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation~     procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life,~     incidence of complications and length of hospital stay. Planned subgroup analyses will be~     performed for conservatively vs surgically-managed subjects and highly vs poorly~     vascularised CSDH.~      DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment~     has yet to be discovered. The TRACS trial will be the first prospective study of TXA for~     CSDH.~   "
37353|NCT02568111|"~     The primary objective of this study is to evaluate the Injection Related Erythema (IRE)~     mitigation effect of a single administration of brimonidine tartrate in comparison with a~     vehicle gel (placebo).~      The secondary study objectives are to evaluate the IRE mitigation effect of a single~     administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent~     definition scale, in accordance with the primary endpoint of the original brimonidine~     pivotal trials and participants' satisfaction with the overall appearance of their skin.~   "
37354|NCT02568098|"~     Primary Objective~        -  To evaluate the safety and tolerability of co-administered single dose~          Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and~          Albendazole (ABZ) in healthy subjects.~      Secondary Objectives~        -  To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ,~          and ABZ in healthy adult subjects.~        -  To characterize the pharmacokinetic properties of PQ (and its major metabolite),~          DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.~        -  To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM,~          ABZ and their metabolites.~        -  To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against~          Anopheles dirus and Anopheles minimus.~        -  To determine if IVM concentrations in venous blood differs from capillary blood.~   "
37485|NCT02566395|"~     This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of~     hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched~     related donors for children and young adults with hematologic malignancies who lack a~     suitably matched related or unrelated donor. The methodology will be one that has been~     successfully utilized in adult patients at Thomas Jefferson University.~   "
37356|NCT02568072|"~     This project will expand on research conducted by the investigators' group, where the~     investigators have demonstrated increased LV trabeculation, satisfying currently existing~     criteria for LV Non-Compaction Cardiomyopathy (LVNC), in groups exposed to high cardiac~     workloads. To the investigators' knowledge, this will be the first prospective study aiming~     to demonstrate a direct relationship between high levels of exercise and increased LV~     trabeculation. This study may add weight to the theory that this entity currently described~     as LVNC, is a morphological epiphenomenon common to many distinct myocardial remodeling~     processes associated with increased cardiac preload and afterload and may better define~     normal adaptive increases in LV trabeculation.~   "
37357|NCT02568059|"~     The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers.~     Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule~     in healthy volunteers. This is Clinical trial Phase I.~   "
37358|NCT02568046|"~     This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination~     with FOLFIRI (chemotherapy) when administered every second week.~      The phase 1b (dose-escalation) portion of the trial is expected to begin Q1 2016. Patients~     will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum~     Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Sym004 in combination with~     FOLFIRI.~      The phase 2a (dose-expansion) portion of the trial is expected to begin after establishing~     the RP2D.~   "
37359|NCT02568033|"~     This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy~     to treat stage II and III lung cancer that is not amendable to surgical resection.~   "
37360|NCT02568020|"~     To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1~     resistance. Further, to explore whether LPD+KA decrease the activation of autophagy~     associate with insulin/IGF-1 pathway.~   "
37361|NCT02568007|"~     The purpose of this study is to examine the effect of standard dosing of cyproheptadine for~     both cycled and continuous administration, as compared to no medication, on appetite~     stimulation and growth in the pediatric gastroenterology feeding team patient population.~     The secondary aim is to evaluate the effect, if any, of the suspected tachyphylaxis that is~     commonly associated with cyproheptadine use. The third aim will be to examine the type and~     duration of side effects of cyproheptadine in this population. The ultimate goal will be to~     create a standardized protocol for cyproheptadine therapy in children with feeding disorders~     and suboptimal growth.~   "
37362|NCT02567994|"~     After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in~     a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg~     to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.~   "
37363|NCT02567981|"~     Adequate nutrition during the first years of life is essential to reach full body and brain~     development potential. Children under the age of 5 in Central America and El Salvador suffer~     from micronutrient deficiencies. In El Salvador, ~ 20% of children under the age of 5 suffer~     from chronic undernutrition which is reflected in low length-for-their age Z-scores and~     anemia. This trial will examine the impact on health and growth in young children that will~     receive either a 21 micronutrient fortified cereal/legume mix manufactured in Guatemala or~     the current standard of nutritional care. The ultimate goal is to identify other feasible~     and effective alternatives to prevent micronutrient deficiencies through culturally~     acceptable vehicles.~   "
37364|NCT02567968|"~     At present clinicians have no way to reverse anesthesia. Patients wake when their bodies~     clear the anesthetic. Most people wake quickly, but some do not. All patients have memory~     and other cognitive problems after waking from anesthesia. In studies on animals, the~     investigators observed that caffeine caused rats and mice to wake much more rapidly from~     anesthesia. This was true for all the animals tested. The investigators would like to see if~     this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse~     the cognitive deficits associated with anesthesia, after waking?~      The investigators hope to start with a very modest pilot program. Each volunteer will be~     anesthetized twice. Each volunteer will be anesthetized one time and allowed to wake without~     the aid of any other drugs and the other time they volunteer will receive a relatively low~     dose of caffeine after anesthesia.~      If no adverse effects are observed in the Pilot program, the investigators will expand the~     study. At this dosage of caffeine, animal studies suggest approximately a dozen volunteers~     will be required to complete the study.~   "
37365|NCT02567955|"~     A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data~     on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent~     vaccine (Cervarix) are available. The main objective of this study is to assess the~     immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old~     girls and boys according to 0-6 month schedule.~   "
37366|NCT02567942|"~     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative~     inflammation can influence to cancer metastasis or recurrence.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
37367|NCT02567929|"~     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative~     inflammation can influence to cancer metastasis or recurrence.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
37368|NCT02567916|"~     The purpose of this study is to compare the incidence and intensity of possible pain on~     injection as well as patient satisfaction caused by long chain triglyceride propofol versus~     medium/long chain combinated triglyceride propofol on endoscopy.~   "
37402|NCT02567474|"~     This study evaluates the effectiveness of self management programs based on 5A model on the~     lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary~     Disease patients. Participants were randomly assigned to an intervention group or a control~     group. The control group were receiving standard practice care and the intervention group~     were receiving intervention in addition to standard practice care. The intervention content~     include implementation of a self management plan based on 5A model.~   "
37486|NCT02566382|"~     Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative~     spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.~   "
37487|NCT02566369|"~     Assessment of the efficacy and safety of CD5789 50μg/g cream applied once daily for 12 weeks~     in subjects with acne vulgaris.~   "
37369|NCT02567903|"~     Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with,~     according to the American Society for Sports Medicine, over 4 million procedures performed~     each year. The risk of venous thrombosis following this procedure is considerable with rates~     of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high~     risk comes about considering its short duration and minimal tissue damage caused by the~     procedure. A factor that may play a role is the use of a tourniquet. A large majority of~     orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of~     a tourniquet. Tourniquet applied surgery is not without risks. Although its use during~     orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to~     loss of muscle functional strength and contractile speed, vessel wall damage and nerve~     injury, next to the possibly increased risk of venous thrombosis. In the proposed study the~     investigators will investigate the effect of a tourniquet on local and systemic markers of~     hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of~     more prominent activation of the coagulation system with tourniquet use than with non-use~     will create an important opportunity to prevent thromboembolic events in these patients, as~     it has been shown that knee arthroscopy can be performed adequately without the use of a~     tourniquet. Furthermore, it will increase the understanding of the pathophysiology of~     thrombosis.~   "
37370|NCT02567890|"~     Women in general and young girls in particular are constantly exposed to unhealthy body and~     appearance ideals through media that contribute to body dissatisfaction and unhealthy~     behaviors such as rigid dieting, which in interaction with genes and other factors increase~     the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The~     investigators aim is to investigate the extent to which an interactive prevention program,~     delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the~     emergence of eating disorders among young females. The sBody Project is based on a~     Dissonance-Based Intervention: (DBI) that has shown very promising results. The~     adaptations and changes in the format of delivery accomplished in this study might help to~     disseminate the program on a broad basis, and consequently affect the health of young~     females on a much larger scale the ever before.~   "
37371|NCT02567877|"~     Patients taking thyroid hormone replacement after thyroid removal surgery often report~     feeling differently than they did prior to taking thyroid hormone. The symptoms can include~     fatigue, worsening mood or subjective brain fog where the patient feels like their~     thinking is just not as sharp as it was previously. Multiple studies have found that~     patients taking thyroid hormone replacement have a diminished quality of life compared to~     matched controls. Previous studies have suggested that the type of deiodinase (DIO)~     polymorphism a patient has, which is responsible for converting the thyroid hormone T4 into~     the more biologically active T3, may contribute to their overall cognition and sense of~     well-being. The Investigators aim to determine if the type of deiodinase polymorphism a~     patient has contributes to the patient's cognition and overall sense of well-being after~     surgery and thyroid hormone replacement.~      Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective~     differences in working memory (N-back test is primary endpoint), cognitive function and~     sense of well-being after thyroidectomy when placed on standard thyroid hormone replacement~     therapy.~      Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working~     memory (N-back test is primary endpoint), cognitive function and sense of well-being on~     standard thyroid hormone replacement therapy after thyroidectomy compared with before~     thyroidectomy.~      (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in~     working memory, cognitive function or sense of well-being on standard thyroid hormone~     replacement before and after thyroidectomy.~   "
37372|NCT02567864|"~     The goals of this research project are: 1) to develop a senior-tailored Healthy Beat~     Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects~     of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility,~     compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.~   "
37373|NCT02567851|"~     An early phase II, single arm, two stage study, to investigate the level of activity,~     duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent,~     utilising a response adapted approach, in older, frailer or co-morbid patients with~     previously untreated Hodgkin lymphoma.~      Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on~     the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.~      At the end of treatment patients will be assessed clinically at 3 months intervals and by CT~     scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years,~     follow-up will be according to local practice.~   "
37374|NCT02567838|"~     The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing~     pain associated with transrectal ultrasonography (TRS) in gynecologic field.~   "
37375|NCT02567825|"~     To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management~     will meaningfully improve children's acute otitis media (AOM) experience over the succeeding~     2 years.~   "
37376|NCT02567812|"~     The aim of this prospective study is to collect data on in-patients with pelvic inflammatory~     disease(PID) at Kangbuk Samsung Hospital.~   "
37377|NCT02567799|"~     The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral~     Suspension when used in combination with standard dose radiation therapy and chemotherapy in~     patients with non-small cell lung cancer. Based on preclinical data the investigators~     hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced~     pneumonitis and pulmonary fibrosis.~   "
37378|NCT02567786|"~     Coagulation abnormalities after pediatric open-heart surgery are complex and very often~     multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the~     coagulation tests during CPB, the younger age has been the most significant risk factor for~     bleeding and transfusion requirements. In children the volume of pump priming is much higher~     compared with the patient's circulating blood volume. For this reason the CPB tubing system~     is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive~     hemodilution and induced coagulopathy. While this is routinely performed in neonates and~     small infants, the routine priming of CPB system with FFP has been questioned in several~     randomized prospective studies in older infants. However, the results of these studies are~     conflicting. Moreover, they show methodological issues.~   "
37379|NCT02567773|"~     GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for~     effects on muscle growth and strength in subjects with muscle wasting to improve their~     physical function. Part A of this study will evaluate the safety, efficacy and~     pharmacokinetics of GSK2881078 in healthy, older men and post-menopausal women who will take~     daily dosing for 28 days and be followed for a total of 70 days. Part B of this study will~     characterize the effect of Cytochrome P450 3A4 (CYP3A4) inhibition on the GSK2881078~     pharmacokinetics. Part B will only be conducted if safe and efficacious dose is identified~     in Part A. Part A will include healthy older males and post-menopausal females; and~     randomize approximately 60 subjects (about 15 per cohort [4 cohorts]) to complete~     approximately 48 (about 12 per cohort). Part B will enroll one cohort of approximately 15~     healthy male subjects to complete approximately 12. The study duration will be approximately~     115 days for Part A and 122 days for Part B.~   "
37380|NCT02567760|"~     This study is set up to determine the cognitive enhancing effect and consumption safety of~     the novel cognitive enhancement product made from the combined extract of Z. mays (purple~     color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.~   "
37381|NCT02567747|"~     The purpose of this study is to provide data on trends of morbidity due to Acute Otitis~     Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related~     health care resources before and after the introduction of vaccination against pneumococcal~     disease within the Universal Mass Vaccination (UMV) in Colombia.~   "
37382|NCT02567734|"~     Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that~     uses a series of short but intense electric pulses delivered by NanoKnife generator through~     paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis~     through irreversibly disrupting cellular membrane integrity. This study aimed to investigate~     the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the~     treatment of patients with locally advanced tumors in different anatomical position.~   "
37383|NCT02567721|"~     The purpose of this study is to conduct a pilot study to explore the potential use of~     routinely collected data in General Practitioner (GP) practices to conduct enhanced safety~     surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim~     guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.~   "
37384|NCT02567708|"~     This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue~     medication), two period crossover study in subjects with persistent uncontrolled asthma,~     currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist~     (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the~     aims of the study are to investigate the efficacy, safety, tolerability, and~     pharmacokinetics of four weeks of treatment with orally inhaled GSK2269557 1000 microgram~     (mcg) in subjects with persistent uncontrolled asthma. In a sub-study, biological mediators~     will be measured from induced sputum and blood.~      Approximately 50 subjects will be randomised into the study (including approximately 16~     subjects in the sputum sub-study). Each subject will complete two treatment periods:~     subjects will be randomised to receive GSK2269557 1000 mcg in one treatment period, and~     matching placebo in the other treatment period. Each treatment will be administered once~     daily for 28 days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).~      The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in~     duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period~     (between the Treatment Periods); and a Follow-up Visit. The total duration of the study for~     each subject will be approximately 16 weeks. DISKUS is a registered trademark of the~     GlaxoSmithKline group of companies.~   "
37385|NCT02567695|"~     The purpose of this study is to evaluate the relative bioavailability of a single 300 mg~     dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3~     × 100 mg) capsule formulation in healthy fasted subjects.~   "
37386|NCT02567682|"~     The purpose of this study to evaluate the effect of concomitant administration of GBT440 on~     caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a~     CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.~   "
37387|NCT02567669|"~     This study examines the extent of systemic muscle loss and the degree of fatigue experienced~     by breast cancer patients undergoing radiotherapy. This study seeks to identify whether~     muscle loss occurs outside the radiation fields and if muscle loss is correlated with the~     degree of fatigue.~   "
37388|NCT02567656|"~     The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K~     delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.~   "
37389|NCT02567643|"~     This study is designed to determine outcome for patients with 5 or more central nervous~     system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).~   "
37390|NCT02567630|"~     This is a prospective interventional study involving young children who will all receive~     non-invasive, passive assessments of sensory and motor function. In addition a subpopulation~     of young children with cerebral palsy will participate in a randomized controlled trial of~     constraint-induced movement therapy, a routinely prescribed therapy used in clinical~     practice for children with motor difficulties. The study attempts to apply a rigorous~     scientific approach to study a widely used but poorly studied practice. The design is an RCT~     with wait-list controls to allow all children to benefit from the therapy, even if they are~     randomized to the control group. All children, regardless of group allocation will continue~     with their standard of care occupational and physical therapy throughout the study.~   "
37391|NCT02567617|"~     The aim of this study was to evaluate the effect of polyphenol supplementation on plasma~     levels of prostaglandin E2 in women during the reproductive period.~   "
37392|NCT02567604|"~     This study will explore experience of AMD caregivers in order to develop a core outcome set~     (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying~     to capture what research outcomes are important from their perspective.~      People 18 years of age and older who have been AMD caregivers for at least 6 months may be~     eligible for this study.~      The aim is to conduct three focus groups lasting approximately one hour. The plan is to~     enrol 18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will~     be involved in conducting the focus groups. A moderator will ensure fluid discussion, while~     the second investigator will be taking notes and audio-recording the discussion.~   "
37393|NCT02567591|"~     Physical exercise has been identified as a major beneficial factor in the management of~     patients suffering from many chronic diseases especially cancer and in the context of~     cardiac or pulmonary transplantation. It contributes to an improvement of the quality of~     life and decreases treatment side effects and mortality. Aerobic fitness is constantly~     altered in cirrhotic patients and correlated to the severity of the hepatic disease.~     Moreover, in this setting, other etiological factors may be added like chronic obstructive~     bronchitis and alcoholic cardiomyopathy. In this population, muscle abnormalities with~     fatigue and cramps have been described. Muscle weakness in this condition may be comparable~     to that described in patients with chronic obstructive bronchitis and contributes to the~     decrease of aerobic fitness. Different causes such as muscle deconditioning, hypoxemia,~     denutrition, anti-rejection drugs increase this phenomenon after liver transplantation.~     Finally, the aerobic capacity or VO2max is a prognostic factor for survival and is linked to~     the number and the length of hospitalizations after liver transplantation (LT).~      Therefore, physical activity is a valid and relevant way to improve quality of life,~     increase survival, and limit costs of hospitalizations. The aim of this study is to assess~     the effects of a personalized physical activity retraining program on aerobic capacity,~     strength and fatigue, in a population awaiting liver transplantation.~      Purpose: The hypothesis is that an at home adapted retraining program conducted before LT,~     and including physical activity (aerobic and strength training), will improve aerobic~     fitness, peripheral strength, quality of life and decrease the hospitalization length in~     intensive care unit after LT.~   "
37394|NCT02567578|"~     This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2~     trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.~   "
37395|NCT02567565|"~     This study will compare cataract patients before and after phacoemulsification. Evaluations~     will be performed before and 1 and 3 months following cataract surgery, including~     measurement of tear film lipid layer thickness, tear film break up time, Schirmer test,~     corneal and conjunctival fluorescein staining, examination of lid margins and meibomian~     glands, and the Ocular Surface Disease Index.~   "
37396|NCT02567552|"~     Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus~     intramuscular progesterone 50 mg/day, to determine whether there are differences in the~     endometrial transformation and endometrial receptivity.~   "
37397|NCT02567539|"~     The study is aimed to evaluate efficacy and safety of re-irradiation for patients with~     recurrent high grade gliomas after other treatment.~   "
37398|NCT02567526|"~     Inadequate food and fluid intake is a common problem among nursing home (NH) residents and~     one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even~     death. The most common nutrition intervention for at-risk NH residents is oral liquid~     nutrition supplementation, although, there is limited controlled evidence of the efficacy of~     supplements in promoting weight gain in NH residents. Moreover, studies show that~     supplements are not provided consistent with orders and residents receive little to no staff~     assistance to promote consumption in daily NH care practice. The result is that~     nutritionally at-risk NH residents with supplement orders receive few additional daily~     calories from supplements. Recent evidence strongly suggests that offering residents a~     choice among a variety of foods and fluids multiple times per day between meals coupled with~     assistance is effective in increasing daily caloric intake and promoting weight gain.~     However, the provision of the between-meal choice intervention requires significantly more~     staff time relative to the amount of time NH staff currently spend on between-meal~     nutritional care provision.~      A new federal regulation allows NHs to train non-nursing staff to provide feeding assistance~     care. Preliminary research has demonstrated that non-nursing staff trained as feeding~     assistants provide mealtime feeding assistance care that is comparable to or better than~     their indigenous nurse aide counterparts. Moreover, a recent demonstration project showed~     that these staff can be used to effectively augment nurse aide staff for mealtime feeding~     assistance care provision in daily care practice. The proposed translational study will~     utilize the federal regulation to train non-nursing staff for between-meal nutritional care~     delivery. Specifically, the proposed study will use a controlled, intervention design to~     determine the cost-effectiveness of the between-meal choice intervention relative to a usual~     care control group in a group of 200 residents across 4 NH sites. Residents with an order~     for caloric supplementation will be included in this study and randomized into either a~     usual care control group or a choice intervention group (100 residents per group). The usual~     care control group will continue to receive standard NH care for supplement or snack~     delivery between meals, as provided by indigenous nurse aide staff. Non-nursing staff~     trained as feeding assistants will offer residents in the intervention group a choice~     between supplements and other snack foods and fluids twice daily, five days per week, for 24~     weeks while also providing a standardized prompting protocol to enhance intake and~     independence in eating. Research staff will independently document the costs of intervention~     implementation and compare these costs to effectiveness measures which include improvements~     in caloric intake, weight and quality of life. These outcomes will be independently~     monitored for both groups across 24 study weeks by trained research staff using~     standardized, validated protocols. This translational research effort will provide critical~     information to improve care practices in nursing homes for nutritionally at risk residents.~   "
37399|NCT02567513|"~     Low oral food and fluid intake and unintentional weight loss are common problems among~     long-stay nursing home (NH) residents and are associated with adverse, costly clinical~     outcomes. This study will use a controlled, intervention design to determine the~     cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition~     intervention that offers NH residents a choice between supplements and other foods and~     fluids (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents~     with an order for supplementation will be included in this study and randomized into one of~     three groups: (1) usual care control; (2) oral liquid nutrition supplementation~     intervention; or (3) choice intervention. The usual care control group will continue to~     receive standard NH care for supplement or snack delivery. Research staff will provide the~     same supplements used by the NH (group two) or a choice between supplements and other foods~     and fluids (group three) twice daily, five days per week, for 24 weeks and document the~     daily costs of intervention implementation when also providing a prompting protocol known to~     improve intake and enhance independence in eating. Based on extensive preliminary data, it~     is anticipated that both groups two and three will require significantly more staff time~     than usual care (group one). Thus, the labor costs of these interventions will be documented~     and compared to effectiveness measures. Effectiveness measures include the following~     resident outcomes: improvements in total daily caloric intake, weight, nutrition and~     hydration status and quality of life. These outcomes will be independently monitored for all~     three groups across 24-weeks by trained research staff using standardized, validated~     protocols.~   "
37400|NCT02567500|"~     The aim of this study is to show presence of cognitive and emotional factors on the~     beginning and persistence of auditory hallucinations in non-psychotic children.~     Investigators will describe a significant link between this factors and hallucinations in a~     sample of non-psychotic children. The results of this sample will be comparing to another~     group of children of the same age, sex and diagnosis, but without hallucination. Finally,~     investigators will control the persistence of hallucination on the first group after a six~     month period.~   "
37401|NCT02567487|"~     The aim of the current study is to investigate the effects of two different doses of~     levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For~     this purpose we planned to include 50 children aged between 2 and 12 that will undergo~     unilateral inguinal surgery.~      The doses that will be used in the study were within usual dose limits which is stated in~     prospectus of the study drug.~   "
37403|NCT02567461|"~     It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be~     treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF).~     Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12~     receptor inhibitor, respectively. However, over the past years, several non-vitamin K~     antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF~     showing encouraging safety and efficacy profiles as compared with warfarin. However, the~     effects of edoxaban in combination with DAPT in the setting of patients with coronary artery~     disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual~     antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents~     another important area of clinical interest. This investigation is a prospective,~     randomized, parallel-design, open label, pharmacodynamic study conducted in patients with~     CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in~     addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel~     only (after stopping aspirin).~   "
37404|NCT02567448|"~     The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural~     changes associated with COPD and upper airway inflammation on upper airway collapsibility.~     Upper airway collapsibility is closely associated with development of obstructive sleep~     apnea (OSA), which is a common disease characterized by repetitive collapse of upper airway~     during sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and~     cardiovascular consequences, especially in patients with COPD.~      Participants in this research study will undergo two overnight sleep studies (PSGs),~     pulmonary function test, and CT scan of the upper airway and chest. The first sleep study~     will evaluate the sleep breathing disorder and the second sleep study will measure the upper~     airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a~     modified continuous positive airway pressure (CPAP) machine which can provide a wide range~     of pressures between 20 and -20 cmH2O in order to modify upper airway pressure.~   "
37405|NCT02567435|"~     This randomized phase III trial studies how well combination chemotherapy (vincristine~     sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan~     hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating~     patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and~     has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Combination~     chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether combination chemotherapy or~     combination chemotherapy plus temsirolimus is more effective in treating patients with~     intermediate-risk rhabdomyosarcoma.~   "
37406|NCT02567422|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970~     (VX-970) when given together with cisplatin and radiation therapy in treating patients with~     human papillomavirus negative (HPV) (-) head and neck squamous cell carcinoma that has~     spread from where it started to nearby tissue or lymph nodes. ATR kinase inhibitor VX-970~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and~     shrink tumors. Giving ATR kinase inhibitor VX-970 together with cisplatin and radiation~     therapy may work better in treating patients with locally advanced HPV- negative head and~     neck squamous cell carcinoma.~   "
37407|NCT02567409|"~     This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with~     or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer~     that has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin~     and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine~     hydrochloride work better alone or with ATR kinase inhibitor VX-970 in treating patients~     with urothelial cancer.~   "
37408|NCT02567396|"~     This phase I trial studies the side effects and best dose of talazoparib in treating~     patients with solid tumors that have spread to other places in the body and usually cannot~     be cured or controlled with treatment (advanced) or have spread to other places in the body~     (metastatic) and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
37409|NCT02567383|"~     Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for~     recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with~     CCRT on recurrent head and neck cancer are tumor response rate, while secondary goals are~     rates of acute and late adverse effects, local control rate, distant metastasis rate,~     progression-free rate and overall survival rate.~   "
37410|NCT02567370|"~     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown~     and remove the drug from the body, safety and tolerability of AMG 581 in healthy~     participants and subjects with schizophrenia.~   "
37411|NCT02567357|"~     'PREDICTORS' (Parents Resources for Decreasing the Incidence of Change Triggered Temper~     Outbursts) aims to evaluate web-based training packages for caregivers of children who show~     frequent temper outbursts following changes to their routines and plans. The training~     packages will teach caregivers how to apply strategies that aim to reduce the number of~     temper outbursts that the children show following changes, as well as making any outbursts~     they do show less severe (less functionally impairing).~   "
37412|NCT02567344|"~     This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking~     Cannabis use disordered participants. Participants will then undergo either active, or sham~     rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.~   "
37413|NCT02567331|"~     This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in~     patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12~     months, and the target sample size is 28 individuals.~   "
37417|NCT02567279|"~     The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal~     factors that regulate the activity of bone cells. This alteration of bone remodeling is~     characterized by increased bone resorption and decreased bone formation, leading to a marked~     reduction of bone mineral density, osteoporosis and an increased risk of fracture.~      To date, there is a paucity of studies and no consensus on the management of bone loss in~     patients with AN. The few previous studies were performed with small samples and using short~     follow-up periods.~      Denosumab is a fully human monoclonal antibody that binds with high specificity to human~     RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore~     decreasing bone resorption that was found increased in patients AN.~      Denosumab may transiently protect bone whilst psychonutritional management will induce a~     weight restoration~   "
37418|NCT02567266|"~     Emotional disorders, including an array of anxiety and depressive syndromes, are the most~     common psychiatric disorders among adolescents, are highly comorbid, and severely impair the~     lives of youth and their families. Extant evidence-based therapies target only single~     disorders or symptom domains, are often not adopted by community mental health center (CMHC)~     clinicians, and have only modest effect sizes. To improve the clinical outcomes of these~     youth, the proposed study tests the effectiveness of two novel interventions (a~     transdiagnostic intervention, the Unified Protocol for the Treatment of Emotional Disorders~     in Adolescents, and a measurement and feedback system, the Youth Outcomes Questionnaires)~     relative to usual care in CMHCs.~   "
37419|NCT02567253|"~     The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the~     pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal~     chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer.~   "
37420|NCT02567240|"~     The goal of this study is to determine whether harvesting islets using carbon monoxide~     (CO)-saturated mediums can protect islet cell from death after autologous islet~     transplantation in patients with chronic pancreatitis.~   "
37421|NCT02567227|"~     The investigators propose to conduct a single-blind randomized clinical trial to test the~     efficacy of a computerized cognitive remediation intervention program on improving~     locomotion in sedentary seniors, a group at an especially high risk for disability. The~     hypothesis is that executive functions will respond to the cognitive remediation program and~     in turn enhance locomotion.~   "
37422|NCT02567214|"~     The investigators will compare the reduction in Borg dyspnea score during the 3-min constant~     rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg~     (Ultibro®) versus Tiotropium 18 µg (Spiriva®) alone in patients with moderate to severe~     COPD.~   "
37423|NCT02567201|"~     Aim : To assess the ability of healthy subjects and patients with a severe motor disability~     to voluntary control their attention~      Material and Methods:~      Population: healthy subjects, patients with brain injury Electroencephalographic study to~     research attentional modulation during different kind of stimulation (visual, auditory,~     tactile)~      Sudy 1: passive recording.~      Study 2: active recording (instruction of attentional control given to the subject).~      Study 3: active recording with a feedback obtained after a processing of the brain activity.~   "
37424|NCT02567188|"~     An observational, longitudinal, multi-center, non-interventional study in participants with~     chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease~     (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis~     situation who are treated with MIRCERA in normal clinical environment.~   "
37425|NCT02567175|"~     FDA currently allows patients 12 years of age and older with various gastrointestinal (GI)~     conditions to be treated with Domperidone through the Expanded Access to Investigational~     Drugs program. These conditions include gastroesophageal reflux disease with upper GI~     symptoms, gastroparesis, and chronic constipation. Patients must have failed standard~     therapies to be eligible to receive Domperidone. This program facilitates availability of~     investigational drugs, (such as Domperidone) to patients with serious diseases or conditions~     when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or~     treat the patient's disease or condition.~   "
37426|NCT02567162|"~     The aim of this project is development of a comprehensive, prospective, multinational,~     multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.~   "
37427|NCT02567149|"~     The primary objective is to determine whether intralesional cidofovir is effective at~     bringing about the total or near-total resolution of warts that have already proven~     recalcitrant to standard therapy.~      The secondary objective is to determine the tolerability of this new mode of administration~     of cidofovir in the pediatric population~   "
37428|NCT02567136|"~     The purpose of the study is to determine if we are able to find one or more biomarkers of~     Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic~     resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A~     biomarker is a measurable characteristic that can be used as an indicator of a particular~     disease state. Identifying biomarkers of a disease can lead to a better understanding of the~     disease as well as improved treatments. This study will enroll patients with ALS, PLS, and~     healthy controls.~   "
37429|NCT02567123|"~     The purpose of this study is to determine whether changing foot strike pattern from a~     rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is~     believed that switching foot strike pattern from a rearfoot strike to a forefoot strike~     pattern will reduce associated running-related patellofemoral knee pain.~   "
37430|NCT02567110|"~     The purpose of this study is to determine the impact of inflammation on central nervous~     system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in~     middle-aged patients with major depression. Depression is associated with significant~     alterations in glutamate concentrations and white matter integrity, which has been~     associated with decreased antidepressant response, poor functional outcome, and cognitive~     impairment.~   "
37474|NCT02566538|"~     Aging is a long term process, starting early in life, and progressively affecting various~     functions and organs. Cardiovascular diseases and cognitive impairment are two conditions~     related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a~     population-based prospective cohort study carried out to develop risk prediction algorithms~     aimed at identifying people who are the most likely to develop impaired psychometric and~     cognitive functioning and impaired cardiovascular risk, in the coming years.~   "
37431|NCT02567097|"~     Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main~     contributor to around 75,000 deaths a year in England. The aim of the present research is to~     test the effect of helping people to reward themselves when they have successfully abstained~     from smoking and the impact this will have on subsequent smoking cessation. Each participant~     will be randomly allocated to one of four conditions. The trial requires 159 participants to~     perform an fully powered statistical analysis. The four conditions include: (1) a control~     condition (asked to form a plan to quit smoking), (2) an implementation intention condition~     (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control~     condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition~     (asked to link temptations with appropriate behavioural responses), (3) a weekly~     self-incentivising condition (asked to reward themselves at the end of each week that they~     have successfully abstained from smoking), or (4) a monthly self-incentivising condition~     (asked to reward themselves at the end of each month that they have successfully abstained~     from smoking). The main outcome measure will be smoking quit status, which will be verified~     biochemically at the end of the stop smoking programme, and at six-months post quit date.~   "
37432|NCT02567084|"~     The purpose of this study is to assess the ability a injectable bi-phasic ceramic bone~     substitute to provide bone generation and bone remodeling in patients with benign bone~     tumors.~   "
37433|NCT02567071|"~     The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the~     1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some~     hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%.~     The use of C-section continues to grow in every countries of the world despite that current~     knowledge leads us to think that the vaginal birth, retained through millennia during~     mammalian evolution, guarantees the implementation of the best suited intestinal microbiota~     to build immunity and beneficial protective functions under the balanced mutual association~     between the host and its microbiota. Oral administration of a previously impregnated swab,~     by vaginal and maternal perineal secretions, following birth by planned C-section, would~     restore the normal development of the newborn intestinal microbiota mimicking exposure to~     these secretions during vaginal delivery.~      The expected benefit is the establishment of a rich and diverse microbiota in individuals in~     the intervention group and by extension improving the overall health of these individuals.~   "
37434|NCT02567058|"~     Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common.~     Up today, the mechanical and elastic properties of the Achilles tendon are still unknown,~     and that both in healthy subjects in pathology. The viscoelastic properties or dynamic~     mechanical properties are directly related to the tendon of the health status and its~     elongation capacity.~      The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive~     ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the~     viscoelastic properties of the tendon during the contraction of the sural triceps.~      This is what we want to do in this first protocol: in vivo observation of the normal values~     and variations, looking for changes related to hyper solicitation and finally trying to~     highlight a tendon fragility parameter for patients who have experienced of a Achilles~     tendon rupture.~   "
37435|NCT02567045|"~     This is a multicenter, controlled, randomized phase III study to compare participation rate~     with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients~     diagnosed of CRC.~      The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test~     is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for~     colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will~     be necessary to include in each group.~   "
37436|NCT02567032|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether~     intranasal oxytocin administration can serve as an adjunct treatment for social impairments~     in schizophrenia.~      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in~     patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition~     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved~     in emotional or sarcastic communication) after administration of oxytocin versus placebo.~      Hypothesis B: Patients and healthy comparison subjects will show increased attention to~     others' eyes and patients will exhibit increased facial affect expressivity after~     administration of oxytocin versus placebo.~      Aim 2: To examine the effects of exogenous oxytocin on PNS activity in patients with~     recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS~     activity during social tasks after administration of oxytocin versus placebo.~      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social~     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS~     activity.~   "
37437|NCT02567019|"~     Periodontal diseases are a group of diseases that affect 15% of the population and in the~     absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by~     strong inflammation and hyper-vascularization. Search in blood cells and inflammatory~     markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be~     assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells,~     complement, proteins of inflammation and cytokines. Current data from the literature on this~     subject give contradictory results and the comparison of studies are difficult because the~     diversity of the populations studied, evaluated cells and the methods used. The aim of the~     study was to evaluate the innate immunity of patients with periodontal disease and compare~     it with a group of patients without periodontal disease.~   "
37438|NCT02567006|"~     This project plans to learn more about whether sending text messages to parents on their~     mobile phones to remind them when their child is due for his or her next vaccination will~     improve children getting vaccinated on time.~   "
37475|NCT02566525|"~     Prospective, multi-center, randomized, feasibility clinical study. Subjects will be~     randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and~     treatment with the CytoSorb® device.~   "
37511|NCT02566057|"~     This study evaluates whether prospective pharmacogenetic testing is cost-effective in~     affecting clinical treatment outcomes in patients with early-phase psychosis.~   "
37442|NCT02566954|"~     The study will be in 3 parts: first one will be to address the key question of the lower~     limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar~     X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb~     disorders is the ability to correctly assess abnormal development and decide on the most~     adapted treatment option. In particular, the link between lower limb disorders and foot~     morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in~     children has been successfully assessed using low-dose biplanar X-rays.~      Second part will be to assess the reproducibility of the 3dimensional reconstructions~     whether they are made by a radiology technician, or by a so-called expert through collecting~     datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get~     spine or lower limb X-Rays.~      Last part will be to work on the recently developed weight-bearing foot 3D reconstruction~     method for clinical use using the Parametric Personalized Modelling approach (PPM). This~     will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.~   "
37443|NCT02566941|"~     Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of~     COPD (chronic obstructive pulmonary disease) patients (among others) to improve their~     resistance to efforts in everyday life. In patients in intensive care, it seems to improve~     strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical~     illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation~     days, with expected effects on the duration of hospitalization and the long-term functional~     outcome. Although its use could sometimes be limited by the development of peripheral edema~     and use of vasoconstrictors, the main advantage of this technique is the possibility of~     being used very early, even in patients that require deep sedation . This is extremely~     important given that the muscular atrophy process already starts 18h after the onset of~     invasive ventilation and as signs of impaired nerve transmission are developed in one third~     of patients at risk within 72 hours.~      The purpose of the study is to assess the effects, in the short and medium term, of early~     neuromuscular stimulation in patients who are at higher risk of developing a critical~     illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.~      This is a randomized controlled single-blind study comparing a group of patients submitted~     to NMES early (up to 5 days after admission) versus a control group unstimulated.~   "
37444|NCT02566928|"~     The overall goal of the project is to develop and evaluate a home-based intervention to~     prevent re-infection and transmission of Community-Acquired Methicillin-resistant~     Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft~     tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include~     incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing.~     Re-infections are common, ranging from 16% to 43%, and present significant challenges to~     clinicians, patients and their families. Several decolonization and decontamination~     interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and~     transmission in intensive care units. Few studies examine the feasibility and effectiveness~     of these infection prevention interventions into primary care settings, and none employ~     Community Health Workers (CHWs) or promotoras to provide home visits for education and~     interventions about decolonization and decontamination. This comparative effectiveness~     research/patient centered outcomes research builds upon a highly stakeholder-engaged~     community-academic research and learning collaborative, including practicing clinicians,~     patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors~     Network (CDN), an established, NIH-recognized best practice Federally Qualified Health~     Center (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose~     to address this question through the completion of four aims: (1) To evaluate the~     comparative effectiveness of a CHW/Promotora-delivered home intervention (Experimental~     Group) as compared to Usual Care (Control Group) on the primary patient-centered and~     clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical~     outcomes (pain, depression, quality of life, care satisfaction) using a two-arm randomized~     controlled trial (RCT). (2) To understand the patient-level factors (CA-MRSA infection~     prevention knowledge, self-efficacy, decision-making autonomy, prevention~     behaviors/adherence) and environmental-level factors (household surface contamination,~     household member colonization, transmission to household members) that are associated with~     differences in SSTI recurrence rates. (3) To understand interactions of the intervention~     with bacterial genotypic and phenotypic variables on decontamination, decolonization, SSTI~     recurrence, and household transmission. (4) To explore the evolution of stakeholder~     engagement and interactions among patients and other community stakeholders with practicing~     community-based clinicians and academic laboratory and clinical investigators over the~     duration of the study period.~   "
37445|NCT02566915|"~     The purpose of this study is to evaluate the effects of the application of Expiratory~     Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in~     patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
37446|NCT02566902|"~     This is a blinded observer randomized controlled trial comparing two nebulizer devices. The~     objective of this study is to evaluate the efficacy of two different nebulizers.~   "
37447|NCT02566889|"~     The purpose of this study is to evaluate whether trough serum infliximab concentrations at~     the time of loss of clinical response will identify pediatric participants with inflammatory~     bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above~     the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)].~   "
37448|NCT02566876|"~     Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly~     Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and~     no safe and effective treatment is available. Although probiotics have shown promising~     results in adults, few studies have been published in children. The Bifidobacterium~     Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial~     bacteria in children and represent 95% of the total bacterial population in the intestine of~     breastfed infant.~      Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria~     on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To~     evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life~     in children with FD and IBS.~   "
37449|NCT02566863|"~     Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart~     rate decreases. With low doses blood pressure also decreases, with higher dosing -~     systematic vascular resistance increases. The indication for the drug is to produce sedation~     during surgical procedures and in ICU patients.~      The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure~     and heart rate variability during drug infusion) depend on pre-drug autonomic system~     activity. Autonomic system activity is assessed using heart rate variability~     (HRV)measurement before drug injection and during drug infusion. Heart rate and blood~     pressure measured before and during drug infusion will be analysed.~      HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug~     injection and during its infusion. 5 minutes intervals will be analysed , using Frequency~     Domain Measures of HRV. Surgical procedure will start after measurement have been taken.~   "
37450|NCT02566850|"~     The purpose of the study is to study the safety and health effects of using the Ekso Bionics~     powered exoskeleton device in a home setting over a 12-36 month period.~   "
37451|NCT02566837|"~     Intramuscular injections of botulinum toxin are currently the best focal treatment of~     spasticity, with clearly defined indications and role. French and European recommendations~     focus on the toxin's mode of administration, which must be as precise as possible. The~     toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the~     importance of targeted injections within the muscle belly. The pain caused by these~     injections is due partly the number of injections (up to 30 in a single session), and partly~     to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused~     by these injections have become a regulatory obligation since the law of 4 March 2002~     relating to the rights of patients and the quality of the health system ( Any person has~     the right to receive relief from pain, which must, under all circumstances, be prevented,~     evaluated, taken into account and treated … ).~   "
37452|NCT02566824|"~     Attention Deficit/ Hyperactivity Disorder (ADHD) is a common childhood psychiatric~     condition, which often persists into adolescence. In adolescence ADHD is associated with~     poor academic, social, and emotional functioning, other psychiatric problems, substance~     abuse, and antisocial behaviour. Although medication effectively reduces symptoms such as~     hyperactivity and inattention, it does not directly address academic, social, emotional, and~     behavioural problems. Overcoming these would require building skills in organization, time~     management, problem solving, emotional modulation, stress management and interpersonal~     rapport. Yet, psychosocial treatments targeting such skills in adolescents with ADHD have~     been little studied and are scarce in the community. The proposed study will evaluate~     cognitive behavioural and skills training therapy (CBT+S) for medicated adolescents with~     ADHD. Adolescents will be stabilized on optimized medication and randomly assigned to 14~     sessions of either manualized group CBT+S or manualized supportive group therapy (SGT). An~     additional treatment-as-usual group will also be included. CBT+S will focus on skill~     acquisition in common problem areas for adolescents with ADHD, such as organization and time~     management, distractibility, impulsivity, and social skills. A coach will call each~     participant twice a week to help practice the learned skills.~      Parallel groups will be provided for parents of CBT+S and SGT participants focusing on~     education, support and sharing experiences. If CBT+S proves to benefit adolescents with~     ADHD, it can be made widely available to these adolescents in the community. This would help~     them improve their academic, social, and emotional functioning and ultimately their long~     term outcomes.~   "
37453|NCT02566811|"~     The primary aim of this trial is to determine whether lymphadenectomy, used to restrict~     adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a~     non-inferior survival as compared to adjuvant therapy given to all women with high risk~     apparent stage 1 endometrial cancer.~   "
37454|NCT02566798|"~     Osteoarthritis is a degenerative disease that affects a growing proportion of the~     population. There is currently no treatment to halt this process. The aim of the research is~     in particular to find treatments targeting the molecular origins of osteoarthritis focusing~     especially on the inflammatory component of the disease. That is why research is looking to~     the development of preventive treatments like nutraceuticals. This project aims to determine~     the anti-inflammatory properties of sera of patients who received supplementation of their~     diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be~     collected during visits for hyaluronic acid injections in OA patients. These sera will be~     tested in vitro in a model of inflamed chondrocytes.~   "
37455|NCT02566785|"~     Purpose: The purpose of this pilot study is to evaluate the effect of a multi-component~     balance & resistance training [RT] intervention on physical function, balance, & falls in~     older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot~     test multi-component balance activities & RT intervention on primary outcomes. 2] Explore~     perceptions related to outcomes & the intervention through focus groups. 3] Generate pilot~     data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training~     intervention.~      Background/Significance: Falls are the leading cause of injury-related deaths in this group.~     Fall risks are even greater for those with HF due to decreased exercise capacity, loss of~     skeletal muscle & medication side effects. Though RT is effective for improving skeletal~     muscle, it has only a modest effect on improving balance, which is comprised of peripheral~     sensory input central integration, & motor output. A multi-component intervention focusing~     on balance retraining & strengthening the muscles supporting static/dynamic balance &~     functional mobility is necessary.~      Methods: Design - Randomized, two-group with wait list control, repeated measures~     experimental design. Sample/ Setting - 40-50 participants recruited from medical center~     heart failure clinic; supervised group sessions conducted in center's health & wellness~     center. Procedures - Participants will be randomized to intervention group or wait list~     control group. Focus groups pre/post intervention. The intervention will be administered in~     1x per week supervised group sessions & 2x a week home sessions. Instruments - 30 Second~     Sit-to-St&, Modified Clinical Test of Sensory Interaction on Balance, Activity Specific~     Balance Confidence Scale, Timed Up & Go, Dynamic Gait Index.~      Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end~     of the first 12 week period for the intervention group with the wait list control group. A~     second analysis will combine data from the delayed intervention period for the wait list~     control group with that from the first 12 week period for the intervention group to test~     change. Supplemental analysis, involving only data from intervention group, will test~     whether change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus~     group data. Aim 3 - adherence assessed by group session attendance & home activities~     completed. Aim 4 - assess & report logistics of conducting the study.~      Nursing Relevance/Implications: This pilot study will initiate the process of developing a~     targeted intervention to induce changes in elderly HF patients to prevent future falls; thus~     reducing costs, physical & emotional burdens related to falls; & effect a major difference~     in the quality of life for this population.~   "
37456|NCT02566772|"~     The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to~     find the maximum tolerated dose of TAS3681.~   "
37457|NCT02566759|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK)~     of single and multiple rising doses of TAK-831 in healthy participants.~   "
37458|NCT02566746|"~     The investigators' study aims to compare the results of percutaneous endoscopic caecostomie~     (CPE) to optimal medical therapy in the treatment of patients with constipation refractory~     to medical treatment. The primary endpoint will be the quality of life assessed by the~     Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are~     digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance~     of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible~     complications. The patients included must meet the classification criteria of Rome III, have~     an elongated colonic transit time, have had a complete colonoscopy and be refractory to~     medical treatment including at least one stimulant laxative or suppositories or enemas~     retrograde.~   "
37459|NCT02566733|"~     Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is~     performed using the Minto model. It was derived from patients undergoing general surgery.~     However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The~     investigators tested whether Minto model for target controlled infusion produces constant~     plasma remifentanil concentration during the cardiac surgery.~   "
37461|NCT02566707|"~     During the past years the treatment of HIV-1 infection has transformed towards chronic~     treatment. Patients are being treated with antiretroviral drugs for many years and become~     older. The risk of developing side-effects due to long term antiretroviral therapy is~     therefore more and more likely. New alternative once-daily maintenance regimes are needed~     for those who are extensively pre-treated and experience side-effects or toxicity on~     standard treatment combinations. A possible once-daily, fully active maintenance regimen is~     the combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen).~     This combination is expected to be a safe, once-daily maintenance regimen with a favorable~     side-effect profile. The combination suits patients with intolerance and/or resistance to~     NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new~     combination the pharmacokinetic profile is unknown and there are no data on short-term and~     long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety~     and efficacy in a small number of HIV-1 infected patients.~   "
37462|NCT02566694|"~     The investigators aim to determine the cause of failure of orthopaedic implants using~     multi-disciplinary analysis of data from patients who have undergone revision.~   "
37463|NCT02566681|"~     The purpose of this study is to evaluate the safety of use of autologous bone marrow stem~     cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients~     with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and~     unblinded clinical trial.~   "
37464|NCT02566668|"~     This research study is being done to learn more about severe asthma by comparing people with~     severe asthma to those with milder forms of asthma and people without asthma, at baseline~     and over time. Individuals are being asked to join a research study to help understand the~     differences in the lungs and blood of participants with severe asthma compared to those with~     milder asthma and healthy individuals, as well as differences in overall health.~     Investigators also want to determine whether these differences predict asthma-related and~     biologic outcomes over 1 year of follow up.~   "
37465|NCT02566655|"~     The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated~     autologous bone marrow cells as a new therapy in patients with established osteoporosis by a~     prospective, single-center, open, non-randomized and unblinded clinical trial.~   "
37466|NCT02566642|"~     When presenting for elective surgery, patient's often do not completely understand the role~     that the anesthesiology team plays in their care. In 1999, the American Medical Association~     (AMA) found that health literacy was a stronger predictor of a person's health than age,~     income, education level and race. It is very important that the investigators provide~     information to patients on the role of anesthesiologists in their care before, during, and~     after the surgery as it has been shown to improve patient anxiety and overall satisfaction.~   "
37467|NCT02566629|"~     Analyze microbiota community of irritable bowel syndrome in episodes phase and remission~     phase.~   "
37468|NCT02566616|"~     Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads~     to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a~     surgical procedure where the nerve is decompressed. Research has shown that nerve simulators~     speed up the recovery of nerves following injury. The purpose of our research is to examine~     the difference in patient outcomes after the nerve decompression surgery with and without~     nerve stimulation.~      Our research questions is: What are the differences in long term functional outcomes of~     patients that have ulnar nerve decompression surgery with and without nerve stimulation?~   "
37469|NCT02566603|"~     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may~     lead to improved platelet levels where these are decreased due to immunological pathologies~     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been~     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The~     primary objective of the study is to assess the efficacy of PRTX-100 in terms of platelet~     response in patients with chronic/persistent ITP.~   "
37470|NCT02566590|"~     One third of independent older adults over the age of 65y will be hospitalized for an acute~     medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults~     will experience functional decline during their hospital stay from the amount of time they~     are physically inactive and in bed. Following discharge, the functional deficits can persist~     for months and in many instances never return to pre-hospitalization levels thus compounding~     morbidity, health care costs and dying. A classic consequence of short-term bed rest in~     older adults is the significant loss in skeletal muscle mass which underlies the accelerated~     leg strength deficits. The investigator has shown that an important mechanism of skeletal~     muscle loss is the inability of nutrients to stimulate a normal muscle protein synthesis~     response; a process highly regulated by the mammalian target of rapamycin signaling pathway~     (mTOR) and amino acid transporters. Day to day maintenance of force generating muscle tissue~     is dictated by anabolic stimulation from muscle contraction and essential amino acid~     ingestion. Therefore, anabolic interventions such as neuromuscular electrical stimulation~     (NMES) and high quality protein supplementation that contains a high proportion of essential~     amino acids (whey protein) may be promising approach to maintain leg muscle mass and~     strength in hospitalized older adults and prevent the long term consequences of repeated~     periods of short-term physical inactivity. The purpose of this study is to test in older~     adults if the combination of NMES and protein supplementation is capable of preserving~     muscle mass and strength and maintaining muscle nutrient anabolic sensitivity during bed~     rest. The investigators current hypotheses are that daily NMES and protein supplementation~     during 5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and~     strength and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling~     and amino acid transporter expression. The long term goal is to utilize this inpatient~     preventative therapeutic approach in a clinical setting in which muscle mass and strength~     deficits are profound (e.g., intensive care patients).~   "
37471|NCT02566577|"~     The purpose of this study is to determine how red blood cell transfusions, particularly the~     length of storage time of units of packed red blood cells, affects the cardiovascular~     function in patients receiving transfusions. This study will also determine the most ideal~     way of storing and processing blood, and assess how transfusion affects a person's ability~     to exercise and how their blood vessels relax and contract.~   "
37472|NCT02566564|"~     Phase I/IIa study to determine the safety and clinical effects of intra-articular injections~     of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.~   "
37473|NCT02566551|"~     The purpose of this prospective randomized controlled study is to compare the improvement of~     symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients~     undergoing prostatic artery embolization (PAE) or conventional transurethral resection of~     the prostate (TURP).~   "
37571|NCT02565277|"~     To assess the impact of influenza vaccination on the overall systemic inflammatory response~     in patients undergoing cardiac surgery and investigate functional and clinical outcomes in~     vaccinated patients postoperatively.~   "
37476|NCT02566512|"~     The investigators propose to assess cough strength in patients undergoing spontaneous~     breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough~     strength under two conditions,~        1. Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff~          inflated and the patient coughing through the tracheostomy tube.~        2. Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff~          deflated and the patient coughing around the tracheostomy tube, through their mouth..~      The investigators hypothesize that patients will have a stronger cough when they can use~     their vocal cords.~   "
37477|NCT02566499|"~     The main goal of this project is to assess the ability of a recently developed Breast~     Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will~     be performed by recruiting fourteen volunteers that have been diagnosed with breast~     abnormalities using x-ray mammography. The breast presenting the abnormality will be imaged~     using the BMI system in a controlled and comfortable environment. As this is a feasibility~     study of the technology, and has the main goal to evaluate the diagnostic accuracy of this~     technology. The data collected from this study will be used to: (1) evaluate the overall~     participant experience during the BMI imaging procedure, (2) optimize the design of the BMI~     imaging system (both hardware and software), (3) open discussions with other medical~     professionals (e.g. radiologists) about the clinical feasibility of this emerging diagnostic~     imaging modality.~   "
37478|NCT02566486|"~     Aim The aim of this clinical study was to evaluate the influence of the instrumentation~     techniques on the incidence and intensity of postoperative pain in single-visit root canal~     treatment.~      Methodology Ninety patients with single root/canal and non-vital pulps were included. The~     patients were assigned into 3 groups according to root canal instrumentation technique used;~     the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and~     rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and~     the severity of postoperative pain was assessed by 4-point pain intensity scale. All the~     participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data~     were analyzed by the Kruskal-Wallis test.~   "
37479|NCT02566473|"~     Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing~     all regions of the country and varied hospital and surgeon practice settings (e.g.,~     urban/rural, low and high volume) to ensure that registry analyses and research reflect~     typical clinical practice thereby providing optimal guidance for patients, clinicians, and~     national healthcare policymakers. Collect pre-operative and post-operative patient reported~     outcomes (PROs) for pain and function.~      Aim 2: Develop new and transformative comparative effectiveness tools useful to both~     clinical practice and healthcare policy.~      Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant~     revision, hip dislocation, knee manipulation, and identify important variation to inform~     quality improvement priorities.~   "
37480|NCT02566460|"~     The purpose of this study is to explore and assess possible outcome benefits of lactate~     clearance＞30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of~     during early resuscitation of septic shock through a single-center randomized controlled~     study. The investigators anticipate to collect 300-400 qualified patients with septic shock~     who were selected from critically ill patients admitted to the Department of Critical Care~     Medicine. The participants can be randomized divided into lactate clearance group and SCVO2~     group. The investigators compared the treatment and the relevant parameters changed after~     different target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days,~     and new emerged organ failure were collected and compared. 28-day survival curves were drew~     between these two group. And the adverse events of the treatment have also been compared.~     Through this study, the investigators want to answer that whether lactate clearance-oriented~     therapy can reduce the mortality in patients with septic shock, compared with ScvO2-oriented~     protocolised therapy.~   "
37481|NCT02566447|"~     The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for~     the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the~     Helicase-Dependent Amplification (HDA) technology and the Solana instrument.~   "
37482|NCT02566434|"~     Participants will receive four different doses of methionine through four month long~     interventions with a two week wash-out period in between intervention. The dose will~     increase with each intervention. Two visits during each intervention will also involve~     receiving stable isotope infusion to determine the metabolism of methionine in the body.~     Participants will also be monitored via blood work and questionnaires regarding overall~     health.~   "
37483|NCT02566421|"~     This pilot clinical trial studies patients' genomic sequencing in determining specific~     treatments, also called Precision Medicine, in patients with cancer that has spread to other~     parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic~     code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid [DNA] sequence~     of a cell or gene) may be identified and matched with available treatment that targets the~     mutated gene or an alternative treatment that may provide benefit for the patient with the~     mutation identified. Precision medicine may impacts patient's response to treatment by~     targeting specific mutations and may increase survival and improve quality of life.~   "
37484|NCT02566408|"~     This clinical trial studies the attitudes, beliefs, and preferences of older stage I-III~     breast cancer survivors towards physical activity. Studies have shown that older~     African-American and women of lower socioeconomic status are more likely than their~     Caucasian counterparts and women of higher socioeconomic status to have functional~     disability at the time of a new breast cancer diagnosis. Functional disability is the~     inability to independently complete activities of daily living and increases health care~     costs and deaths. The poor health status of older African-Americans with breast cancer has~     been suggested to diminish the long-term benefits from cancer treatment, resulting in older~     African-American women more likely to die from breast cancer compared to Caucasians.~     Questionnaires that measure the attitudes, beliefs, and preferences of older breast cancer~     survivors may lead to the development of an intervention that increases physical activity,~     improves functional and health status, and improves breast cancer treatment benefits~     translating to improved survival among older breast cancer survivors in general, and in~     particular among older African-American and lower socioeconomic status women with breast~     cancer.~   "
37488|NCT02566356|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether~     intranasal oxytocin administration can serve as an adjunct treatment for social impairments~     in schizophrenia.~      Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as~     measured by fMRI during a well-characterized affect-labeling task in patients with~     recent-onset schizophrenia and healthy comparison subjects.~      Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when~     passively viewing faces, which will be normalized by administration of oxytocin.~      Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling~     faces and this hypo-activity will be normalized by oxytocin administration.~   "
37489|NCT02566343|"~     This prospective study intends to investigate the incidence of postoperative pulmonary~     complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD~     undergoing high-risk noncardiac major surgery and to identify relevant risk factors.~     Furthermore, this study aims to quantify and compare the diagnostic performance of~     preoperative functional tests, exercise capacity, clinical assessment tests and predictive~     scoring systems to predict PPC or in-hospital mortality in these patients.~   "
37490|NCT02566330|"~     The aim in the current proposal is to evaluate the long-term outcome of the EndoBarrier~     device. The group of participants the investigators want to study participated in earlier~     studies at the Maastricht University Medical Center (MUMC) and the Atrium Medical Center in~     Heerlen. Three years of follow-up after the EndoBarrier device is now available. The~     investigators hope to give new insights in the postoperative status and postoperative~     symptoms experienced by the study participants using standardised questionnaires and~     evaluating blood samples. The goal of the investigators is to study the long-term effect of~     the EndoBarrier procedure and to possibly provide insight in the relation between~     success/failure and objective parameters.~   "
37491|NCT02566317|"~     A trial testing the efficacy of sit-stand workstations on decreasing sitting time and~     increasing light-intensity physical activity in samples of office worksites.~   "
37492|NCT02566304|"~     This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy~     before donor stem cell transplant in treating patients with hematologic malignancies. Giving~     low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a~     donor stem cell transplant may help stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may~     also reduce the side effects of the donor stem cell transplant.~   "
37493|NCT02566291|"~     In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain~     are investigated.~   "
37494|NCT02566278|"~     The investigators hypothesis is that upper airway collapsibility (Pcrit) in patients with~     obstructive sleep apnea (OSA) can be measured using equipment found in the clinical sleep~     laboratory and these Pcrit measurements obtained using clinical sleep laboratory equipment~     is comparable to those obtained using research equipment. OSA is a common disease~     characterized by repetitive collapse of the upper airway during sleep, leading to hypoxemia~     and arousals, and which has important neurocognitive and cardiovascular consequences. The~     single most important factor in the development of OSA is upper airway collapsibility: those~     with a more collapsible upper airway tend to have OSA while those with a stiffer upper~     airway do not. The gold standard treatment for OSA is continuous positive airway pressure~     (CPAP), which acts by stenting open the collapsible airway. Upper airway collapsibility can~     be measured during sleep by changing the CPAP level and assessing the change in inspiratory~     flow through the upper airway. Although technically feasible, these measurements are~     typically only undertaken in research laboratories with specialized equipment. The purpose~     of this study is to measure upper airway collapsibility using clinically available (i.e.~     equipment found in a clinical sleep laboratory) equipment only. If successful, upper airway~     collapsibility could be routinely measured in clinical practice, which could help inform~     treatment decisions and help individualize therapy for OSA.~   "
37495|NCT02566265|"~     The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster~     to all patients with monoclonal gammopathies (irrespective of age) will lead to~     seroconversion rates exceeding 50% and more importantly, will reduce influenza-related~     morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the~     end of the flu season~   "
37496|NCT02566252|"~     This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol~     sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.~   "
37497|NCT02566239|"~     The purpose of this study is to learn more about how to maintain health and independence for~     seniors by developing tools that collect data constantly from their home. Caregivers can~     then use this information to make decisions about their health care, such as when an~     individual may not be able to live independently any longer. Specific Aims of this study~     are:~        -  Aim 1: To identify trends in our data that predict health decline. To serve this aim,~          we want to test a number of tools that we have developed, such as in-home sensors, to~          determine which ones are best at measuring health risks in seniors. After collecting~          information for one year, we will look at which tools could be most useful to provide~          feedback to seniors and their communities about the process of aging.~        -  Aim 2: To develop a system for analyzing the data we collect and presenting a summary~          of the data to care teams.~        -  Aim 3: To validate our data and the computer-based tool in senior community settings.~   "
37498|NCT02566226|"~     Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed~     under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the~     patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic~     episodes is unknown. The objective of this randomised controlled trial is to investigate the~     effect of intrathecal morphine and surgery on apneic episodes.~   "
38009|NCT02559531|"~     The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in~     Switzerland, France and Belgium. No validated triage scale is actually used by Emergency~     Medical Service (EMS) providers. The objective of this project is to evaluate the~     reliability and performance of triage by EMS providers with the SETS.~   "
37499|NCT02566213|"~     The human performance during weightlessness was tested in a multiplicity of laboratory~     experiments during parabolic flights and in space. It is therefore known that human fine~     motor skills as grasping are affected by the impact of changing gravity levels. However,~     because everyday life movements differ in several aspects from those done in an experimental~     lab situation, investigators do not know until know if this kind of movements is altered in~     the same extend.~      Fine motor skills seem to depend on the context in which they are made. Thus, the~     performance in weightlessness during everyday life could substantially differ from the~     results given by previous laboratory studies.~      This assumption will be tested in the present project, with subjects executing one and the~     same grasping movement in two different contexts, both in normal gravity conditions and in~     weightlessness. To that end, the investigators developed a new method which allows comparing~     the same grasping movements under different conditions.~   "
37500|NCT02566200|"~     Over the last two decades, considerable progress has been made in the management of~     myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase.~     However changing practices in the real world and their impact on prognosis in the medium~     and long term patients admitted to the intensive care unit for acute myocardial infarction~     are relatively little studied exhaustively.~      The study of clinical, biological and genetic characteristics of patients and their~     conditions of care, help to identify patients at risk for increased morbidity and mortality~     after myocardial infarction and could be the basis for the subsequent realization of~     specific studies on the optimal therapeutic management of the disease according to the~     different risk profiles.~   "
37501|NCT02566187|"~     A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the~     Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of~     Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.~   "
37502|NCT02566174|"~     Background:~      Cancer causes changes in the lives of patients and in the lives of their caregivers.~     Patients and caregivers feel stress and they affect each other as they deal with these~     changes. They each cope with cancer diagnosis and treatment on their own. They also cope~     together. Researchers want to explore this shared change of roles and responsibilities. They~     will do this by gaining insight into the social experience of cancer caregiving. They also~     want to better understand the ways caregiver/patient teams manage the cancer diagnosis and~     experience. This can help find new ways to support caregivers and their patients.~      Objective:~      To explore the shared change of roles and responsibilities of patients and caregivers by~     studying the social experience of cancer caregiving.~      Eligibility:~      English speakers ages 18 and older who are one of the following:~      A cancer patients at the NIH Clinical Center (CC)~      A caregiver of a CC cancer patient~      Design:~      Participants will have been screened by the CC.~      Patients and caregivers will be interviewed separately. This will last up to an hour and a~     half.~      Participants will complete online surveys.~      Participants may have a follow-up phone interview. This will last up to 15 minutes.~   "
37503|NCT02566161|"~     Data on transgenerational effects following nuclear accidents are important for~     understanding fully the consequences of parental exposure to ionizing radiation. Few studies~     to date have had adequate statistical power to detect effects of the magnitude expected~     based on animal data, and most have not been of low-dose, protracted exposures associated~     with nuclear accidents and their aftermath. Although, to date, scant use has been made of~     the new genomic technologies, in Chernobyl-exposed areas of Ukraine and Belarus, excess~     minisatellite mutations have been seen in children born after the accident. We propose a~     study of parent-child trios in which at least one parent was exposed to Chernobyl radiation~     as a clean-up worker (mean dose >=100 mGy) and/or evacuee from a contaminated area (mean >=~     50mGy). The specific aims are to investigate the transgenerational and de novo mutation~     rates of the spectrum of genetic variants in trios, in particular looking at effects in~     children and mapping them to possible parental origin of the chromsome. Together with~     long-term collaborators at the Research Center for Radiation Medicine (RCRM) in Kiev,~     epidemiologic data will be collected for up to 450 trios of parents with preconceptional~     doses and their unexposed offspring. We will use state-of-the-art genomic technologies to~     characterize the landscape of the genomes of the trios to determine whether parental~     radiation exposure is associated with genetic mutations transmitted to the offspring, by~     examining de novo mutation rates, minisatellite mutations, copy number alterations, and~     variations in telomere length. The analysis will be conducted in peripheral blood and/or~     buccal samples (when blood is not available) from complete father-mother-child trios. Doses~     to the gonads from the time of the accident to the time of conception will be reconstructed~     for all parents using existing records supplemented by interview data.~      Trio subjects will be selected from representative populations exposed to radiation from~     Chernobyl who are under active follow-up in the Clinico-Epidemiologic Registry at RCRM. To~     help identify specific effects of paternal and maternal radiation exposure, we will~     initially select sets of trio subjects in five categories: (1) exposed father, unexposed~     mother; (2) unexposed father, exposed mother; (3) both parents exposed; (4) both parents~     unexposed; and (5) a group of high dose emergency workers with acute radiation syndrome. All~     trio members will be invited to the RCRM outpatient clinic for collection of a 20 ml blood~     sample (or buccal cells for those who refuse phlebotomy). Both parents will be asked to~     complete a general questionnaire to obtain demographic and lifestyle data. Then one or both~     will complete detailed dosimetry questionnaires, based on forms used in previous~     collaborations with RCRM and administered by specially trained interviewers. Once 50 trios~     have been recruited (10 from each of the 5 exposure categories), we will conduct an interim~     evaluation of participation rates, sample collection and quality, and dose reconstruction in~     order to modify the protocol as needed. The analytical approach will be to correlate the~     extent, especially for de novo events of genetic alterations in the offspring with parental~     preconceptional radiation dose overall and by parental origin. The statistical power in~     relation to de novo mutations is very high, in excess of 90%, but somewhat lower for trends~     in minisatellite mutations. Study findings will contribute importantly to knowledge of the~     heritable effects of moderate- and low-dose radiation exposure in humans and to radiation~     risk projection. Eventually data from the Trio Study may be shared with the international~     community through dbGap.~   "
37504|NCT02566148|"~     Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in~     France and are among the most exposed to HIV infection and hepatitis B.~      The Parcours study aims to understand, among sub-Saharan African migrants, how social and~     individual factors combine in the course of migration and settlement in France, and~     influence the risk of infection, access to prevention and care, and the effectiveness of~     care for both HIV and hepatitis B diseases.~      The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants~     reside. It consists in a cross-sectional observational survey, using a life-event history~     approach that reproduces the sequence of different life and health events, and contributes~     to explain the present situation (type of disease management, patient's quality of life) in~     light of all the elements of the past trajectory (administrative, familial, socio-economic,~     professionals).~      A representative survey was conducted between February 2012 and May 2013 in health care~     facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group~     living with HIV, a group living with chronic hepatitis B and a group who has neither of~     these diseases. For each group, stratified random sampling was used. The survey was~     conducted in 24 hospital services providing HIV care, 20 health care facilities providing~     hepatitis B care, and 30 primary health care facilities.~      Were eligible all patients attending these health care facilities, born in a Sub-Saharan~     African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with~     an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than~     three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group).~      Among the patients offered participation, 926 HIV-infected patients, 779 patients infected~     by hepatitis B, and 763 patients without these two diseases participated in the study.~      For all participants, detailed information on socio-demographic characteristics; migration~     and life conditions in France; social, sexual and reproductive life history; and screening~     and care history were collected using a life-event history questionnaire administered~     face-to-face by a specialized interviewer. Health care professionals documented clinical~     information from the medical records. Data was collected anonymously.~   "
37505|NCT02566135|"~     Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway )~     have been used as a conduit for tracheal intubation using ventilating bougie. General~     Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia.~     Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs~     as a conduit for tracheal intubation helps in securing airway. This will be further~     facilitated by using ventilating bougie, as it maintains oxygenation.~   "
37506|NCT02566122|"~     Normal values for muscle strength using hand held dynamometer and muscle mass using~     echography are largely unknown. The objective of the present study is to establish normal~     values of these measurements in population living in France.~   "
37507|NCT02566109|"~     The overall of this proposal is to test in community hospitals the utility of a 10-min~     magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis~     algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for~     breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with~     a time-efficient method to identify those at risk of a future CV event so that prevention~     can be implemented to prolong survival and reduce morbidity in cancer survivors.~   "
37508|NCT02566096|"~     This study aims to compare the analgesic efficacy of transversus abdominis-plane block with~     bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer~     surgery.~   "
37509|NCT02566083|"~     Post-approval study to evaluate the rates of visual distortions for patients requiring >2.0~     D of corneal astigmatism correction~   "
37510|NCT02566070|"~     This multi-center, prospective, randomized comparative effectiveness intervention study will~     evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect~     on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated~     critically ill children for up through 24 hours post achievement goal feeds or exclusion~     from feeding protocol, whichever comes first, to a maximum of 10 days.~   "
37512|NCT02566044|"~     This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top~     of standard of care. The study will be divided into 3 Cohorts. Cohorts 1 and 2 are designed~     to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to~     assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled~     QBW276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis~     regardless of their genotype.~      In contrast, cohort 3 is a randomized, double-blind, placebo-controlled, cross-over design,~     multiple dose study to assess the efficacy, safety, tolerability and pharmacokinetics of~     inhaled QBW276 over 4 weeks in patients with cystic fibrosis who are homozygous for the~     F508del mutation. The primary rationale for cohort 3 will be to assess efficacy in a high~     unmet need cystic fibrosis patient population.~   "
37513|NCT02566031|"~     To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg~     once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min~     and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD~     patients~   "
37514|NCT02566018|"~     This study is set to evaluate a proposed standard for the treatment of proximal humerus~     fractures~   "
37515|NCT02566005|"~     A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital~     labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb~     together with vaginal misoprostol will result in shorter induction to delivery time compared~     with vaginal misoprostol alone~   "
37516|NCT02565992|"~     This study will employ a phase Ib design using the established dose of CAVATAK with~     pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered~     standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be~     important in amplifying the T-cell potentiating effects of pembrolizumab.~   "
37517|NCT02565979|"~     The main objective of the study is to investigate if 6 months resveratrol supplementation~     can improve glucose tolerance in overweight/obese individuals. As secondary objectives we~     want to investigate whether resting energy metabolism, intra-hepatic lipid content, physical~     performance, body composition and quality of life change by 6 months resveratrol~     supplementation in these individuals.~   "
37518|NCT02565966|"~     The purpose of this study is to better define the potential molecular and anti-inflammatory~     changes induced by the modified Atkins diet in the brains of patients with treatment~     resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to~     compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20~     subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks~     prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher~     carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects~     in this study to compare serologic and brain tissue specimens. Approximately five (5)~     subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5)~     subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue~     specimens will be obtained at the time of surgery and will be compared. The goal of this~     study is to identify whether or not there are changes in neuroinflammation or~     neuroexcitability in the human brain induced by the modified Atkins diet.~   "
37519|NCT02565953|"~     In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA)~     balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal~     arteries. This device combined the mechanical action of PTA balloon with the~     antiproliferative effects of paclitaxel. The use of these devices in venous pathology is~     limited. This devices could improve the treatment of renal dialysis arteriovenous fistula~     stenosis.~   "
37520|NCT02565940|"~     This work also highlights the presence of an unknown virus double-stranded DNA. In this~     project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot~     infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet~     previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a~     minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the~     most frequent new species frequency in the disease and incidentally get a sense of their~     role in the evolution and prognosis of the disease, including failures of and targeted~     antibiotic therapy on all 150 samples.~   "
37521|NCT02565927|"~     The aim of this study was to evaluate the safety and effectiveness of an radioactive airway~     stent loaded with 125I seeds compared to a conventional airway stent in patients with~     malignant airway obstruction caused by both primary and metastatic malignant tumors.~   "
37522|NCT02565914|"~     This is a Phase 3, multicenter, open-label, rollover study in subjects with CF who are~     homozygous or heterozygous for the F508del-CFTR mutation and who participated in Studies 103~     (NCT02070744), 106 (NCT02347657), 107 (NCT02516410), 108 (NCT02392234), 109 (NCT02412111),~     and 111 (NCT02508207). The study is designed to evaluate the safety and efficacy of long~     term treatment of VX-661 in combination with ivacaftor.~      This study consists of a Treatment Cohort and an Observational Cohort. The Treatment Cohort~     and the Observational Cohort will be open to enrollment in parallel.~   "
37523|NCT02565901|"~     This partially randomized phase I/II trial studies the side effects and how well sirolimus~     works when given together with docetaxel and carboplatin in treating patients with~     hormone-resistant prostate cancer that has spread to other places in the body. Biological~     therapies, such as sirolimus, use substances made from living organisms that may stimulate~     or suppress the immune system in different ways and stop tumor cells from growing. Drugs~     used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving sirolimus together with docetaxel and carboplatin may~     kill more tumor cells.~   "
37524|NCT02565888|"~     This study aims to provide the evidence that 150mg of cobicistat will have the same effect~     on the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together~     with atazanavir 300mg.~   "
37572|NCT02565264|"~     This study is an open prospective clinical trial. The objective is to evaluate the effect of~     autologous exosomes rich plasma on cutaneous wound healing. The participants are patients~     with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease,~     chronic venous insufficiency, decubitus or burns). The participants will be treated~     autologous exosomes rich plasma every day for 28 days. The cutaneous wound healing will be~     evaluated by the length, width and depth of the wound.~   "
37525|NCT02565875|"~     Obstetrics and Gynecology residents, fellows and attending physicians will be randomized to~     view one of two educational presentations of equal duration. The intervention presentation~     will demonstrate the use of a standardized language for effective communication of~     laparoscopy commands. Both groups will be asked to perform a simulated laparoscopic task.~     Participants will be timed and use of the standardized language will be tracked and~     tabulated. The primary outcome of interest is whether the use of standard commands during a~     simulated laparoscopic task is associated with sooner completion of the task. This may~     translate into improved efficiency in the operating room.~   "
37526|NCT02565862|"~     This study aims to provide clinical information on a potential drug-drug interaction between~     daclatasvir and metformin.~   "
37527|NCT02565849|"~     The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in~     defects in the red cell structure. In the investigators' country, this disease affects about~     3,000 children each year and is considered one of the most prevalent disorders among the~     group of existing hereditary diseases.~      The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides~     being the leading cause of death and the second leading cause of hospitalization in SCA, the~     STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke~     vaso-occlusion of capillaries that supply the brain tissue.~      Traditional tests of pulmonary function allow assess whether the person has any commitment~     in the respiratory system, whether obstructive, restrictive or mixed. To run these tests it~     is necessary that the patient understands and performs a forced expiratory maneuver to~     obtain reliable results. In the particular case of SCA, performing these tests it is very~     difficult due to the presence of cognitive impairment of varying degrees. This results in~     underdiagnosis of early changes in the lung parenchyma during the therapeutic window,~     committing the proper monitoring and treatment offered to these patients.~   "
37528|NCT02565836|"~     This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate~     (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of~     inactivated prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of~     warfarin-associated major hemorrhage.~   "
37529|NCT02565823|"~     The purpose of this study is to find out whether exercise leads to changes in the blood that~     are produced by exercised muscles and if these changes produce new hormones that affect the~     body's regulation of sugar and body weight.~   "
37530|NCT02565810|"~     A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects~     with Rheumatoid Arthritis.~   "
37531|NCT02565797|"~     Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its~     effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative~     setting. The primary objective of the study is to compare the prevention-effectiveness~     (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care~     pressure-relieving device(s) (control group) peri-operatively to discharge.~   "
37532|NCT02565784|"~     The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and~     Restylane Perlane Lidocaine after the first and second treatment when used for facial~     augmentation in Asian population.~   "
37533|NCT02565771|"~     Survival rate of childhood cancers is now reaching 80%. However, early or late complications~     related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk~     of late mortality.~      Health of individuals is closely correlated to the stability of the autonomic nervous system~     (ANS), a key system for maintaining homeostasis in any living species. Efficient computer~     tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either~     directly or at a later time by an analysis of the heart rate variability (HRV). These tools~     have become very powerful predictors of cardiovascular morbidity and neurological aging.~     Physical endurance training improves both maximal aerobic capacity and ANS activity.~   "
37534|NCT02565758|"~     This is an open-label dose escalation study designed to evaluate the safety and~     pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or~     in combination with standard therapies) in subjects with advanced solid tumors.~   "
37535|NCT02565745|"~     A single randomized clinical trial (called a central randomization, random number table,~     sealed), blind (investigator and statistician do not know the intervention of each patient)~     is proposed; in adult patients admitted to health facilities with surgical or medical~     purposes, with high and very high risk of developing pressure ulcers (UPP) according to~     Braden scale, but with healthy skin at hospital entrance. Using a design of parallel groups,~     the efficacy of the administration of skin dressing protection versus conventional care~     (lubricant or moisturizer cream), will be evaluated in the prevention of pressure ulcers in~     hospitalized patients in two institutions fourth level of care.~   "
37536|NCT02565732|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with primary~     axillary hyperhidrosis.~   "
37537|NCT02565719|"~     NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg)~     both preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated~     HBsAg clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha~     2a to restore host immunological control of HBV infection. REP 2165 is a version of REP 2139~     which has been shown preclinically to retain antiviral activity with lower accumulation in~     the liver.~      Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate~     complexes, which improve their administration tolerability. This open label, randomized and~     controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy~     in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir~     disoproxil fumarate and pegylated interferon alpha-2a.~   "
37538|NCT02565706|"~     This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition~     education lesson to promote farmers' market fruit and vegetable purchases and consumption~     among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and~     Children (WIC).~   "
37596|NCT02564939|"~     Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been~     unsatisfactory and prevention is the preferred goal. Based on limited experimental research,~     ramelteon appears to have promise for prevention. This study will evaluate ramelteon in~     prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.~   "
37539|NCT02565693|"~     There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients~     with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with~     oral anticoagulation. These patients are currently treated with vitamin K antagonists,~     antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional~     preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive~     alternative in terms of a low risk of recurrent ICH, while at the same time being effective~     for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the~     rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a~     recent anticoagulation-associated intracerebral haemorrhage who are treated with apixaban~     versus those who are treated with antiplatelet drugs or no antithrombotic drug at all.~      This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded~     outcome assessment design.~   "
37540|NCT02565680|"~     Acute urticaria is common and affected 12% of population. 400 patients come in department~     emergency of Toulouse each year and there aren't many studies in literature which evaluate~     the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but~     glucocorticoids treatment administered orally for short course would permit to increase~     quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded~     of adults with acute urticaria less 24 hours duration and no take treatment urticaria~     before.~   "
37541|NCT02565667|"~     The most challenge for the surgery of low rectal carcinoma was whether to perform low~     anterior resection (LAR) and preserve anal function improving the quality of life for~     patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in~     reported literature. Up to now, kinds of surgical devices have been employed to reduce~     anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the~     problem of dog ear phenomena. In the present clinical trial, the investigators use a~     double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal~     resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear.~     The investigators aim to demonstrate the safety, effectiveness of this procedure and~     establish a standard method for laparoscopic (ultra-)low anterior rectal resection.~   "
37542|NCT02565654|"~     Irritable bowel syndrome (IBS) is a common disease and the pathogenesis of this disease~     includes central and peripheral mechanisms. In recent years, there were many studies~     suggesting that microbiota in the intestine may play an important role in the IBS.What's~     more, small intestinal bacterial overgrowth (SIBO) may be an important pathogenic factor for~     IBS and the use of antibiotics may be beneficial. Therefore, the investigators intend to~     explore the efficacy of rifaximin for IBS-D in Chinese population.~   "
37543|NCT02565641|"~     This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV)~     gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The~     anticipated time on study treatment is 3 to 12 months, and the target sample size is 56~     individuals.~   "
37544|NCT02565628|"~     This study is designed to assess safety, tolerability and pharmacokinetic data for multiple~     doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this~     study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with~     placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.~   "
37545|NCT02565615|"~     The study is to verify atorvastatin effectiveness and safety in Chinese population, and~     explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。~   "
37546|NCT02565602|"~     This study aims to: 1) quantitatively assess parameters of bone calcium balance in healthy~     postmenopausal Asian women of Chinese descent; 2) assess possible ethnic differences in~     calcium metabolism by direct comparison of acquired data in Chinese postmenopausal women~     with those acquired earlier in Caucasian postmenopausal women using the same methodology; 3)~     assess differences in calcium and strontium metabolism in parallel to evaluate if strontium~     stable isotopes can be used for tracing bone calcium metabolism qualitatively~   "
37547|NCT02565589|"~     To investigate natural killer (NK) cell activities, circulating cytokine levels and~     peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill~     patients.~   "
37548|NCT02565576|"~     The purpose of this study is to evaluate safety, tolerability,~     pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of~     care in patients with moderate to severe myasthenia gravis (MG).~   "
37549|NCT02565563|"~     The purpose of the study is to gain greater insight into Eye Movement Desensitisation~     Reprocessing (EMDR). EMDR is an NHS recommended treatment, which can significantly reduce~     trauma symptoms. There is some debate regarding how it actually works, however there is~     evidence to suggest that the eye movements component helps reduce anxiety and increase~     relaxation levels. To measure these arousal levels during EMDR previous research has used~     electrocardiography (ECG) to measure heart rate, which offers insight into the effectiveness~     of eye movements (EM). All studies to date have used ECG to measure arousal levels which~     requires technical knowledge to administer and interpret. Furthermore, applying electrodes~     to a patient experiencing PTSD may heighten anxiety. The present study will use new~     technology which is a small device that would be gently attached to the end of the patient's~     index finger. This device is very similar to one that measures oxygen levels in the blood~     and therefore is a very simple piece of equipment and should cause no discomfort to the~     patient. The study also requires patient's faces to be video recorded throughout and it will~     only be their face that is recorded. This is to match the stages of treatment (i.e. when EM~     starts and stops) to their corresponding arousal level outcome. The new technology will~     digitally measure the patient's anxious and relaxed arousal levels during EM and no EM~     treatment sessions. 10 NHS patients would be recruited to receive two treatment sessions;~     one with EM and one without and then continue with treatment as usual without any of the~     recording devices. EM and no EM phases occur at least three times within a treatment session~     and therefore several measurements can be taken and analysed.~   "
37550|NCT02565550|"~     To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota~     community is associated with its efficacy.~   "
37551|NCT02565537|"~     The investigators are comparing outcomes of LASIK surgery using a high definition~     wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with~     and without astigmatism.~   "
37552|NCT02565524|"~     Childhood schizophrenia early dissociative disorder is a rare disease with a low incidence~     of approximately (1 0/00 to 30/00 ). Its link with autism spectrum disorders remains unknown~     although both are serious neurodevelopmental diseases. As part of the 2011-2013~     Interregional hospital Clinical Research program, University Department of Child and~     Adolescent Psychiatry Pediatric Hospitals of CHU (Centre Hospitalier Universitaire) de Nice~     Lenval identified 15 patients with a complex phenotype characterized by an early~     schizophrenia associated with autism spectrum disorders and developmental disabilities in~     mild to moderate. This phenotype could be a new syndrome called schizotiste.~      The goal of the investigator's project is to define the genetic causes of this phenotype.~     The technique of high throughput sequencing will be used to obtain the sequence of exomes of~     these patients and their families. This study will therefore be important to give an~     accurate diagnosis for patients and their families. Moreover, investigators believe that~     this project will identify new genes involved allowing a better understanding of the~     pathophysiology. Recent studies show the involvement of mutations in several genes (eg~     Shank, NLGN, NRXN and UPF3) in these different clinical phenotypes. However, the genetic~     basis of the child's schizophrenia are much less well known than those of autism spectrum~     disorder.~   "
37553|NCT02565511|"~     The purpose of this study is to test whether two investigational drugs called CAD106 and~     CNP520, administered separately, can slow down the onset and progression of clinical~     symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop~     clinical symptoms based on their age and genotype.~   "
37554|NCT02565498|"~     This study is designed to determine if preoperative image guided radiation therapy (IGRT)~     delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in~     similar short-term wound healing complications as surgery followed by postoperative IGRT in~     patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive~     preoperative radiotherapy, half will receive postoperative radiotherapy.~   "
37555|NCT02565485|"~     Epidural anesthesia, the most common method of pain control in labor, can contribute to~     alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the~     administration of an IV fluid bolus (preload) is standard prior to epidural placement.~     However, the optimal volume of preload is unknown and no clinical trials have evaluated a~     risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric~     literature have suggested that a narrow pulse pressure (difference between systolic and~     diastolic blood pressures) is a marker of reduced intravascular volume status and may~     identify women at a higher risk for new onset fetal heart rate changes after epidural~     placement. Therefore, the purpose of this study is to assess if an increased IV fluid~     preload bolus among women with a narrow pulse pressure reduces the risk of new onset fetal~     heart rate changes after epidural placement.~   "
37556|NCT02565472|"~     The goal of this study is to determine subjective gastrointestinal tolerance response and~     differences in breath hydrogen response following the consumption of two types of juice.~     This double-blind crossover study requires participants to arrive to the lab 12 hours~     fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as~     well as produce samples for breath hydrogen analysis at various time points over the next 3~     hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post~     consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior~     to their scheduled visit times to assure compliance.~   "
37557|NCT02565459|"~     The general aim of the present study is to test a cell therapy with third-party ex-vivo~     expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce~     tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared~     accordingly to established protocols, starting from the remnants in the bag and filter at~     the end of the bone marrow infusions. From these samples, MSCs will be expanded in good~     manufacturing practice (GMP) approved facilities and used for the present study in patients~     undergoing kidney transplantation.~      The proposed study will be developed in two phases: i) a pilot explorative~     safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).~   "
37558|NCT02565446|"~     A variety of liver insults lead to pathological changes in liver architecture that culminate~     in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development~     of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver~     fibrosis through non-invasive means that involve measurement of liver stiffness. However, a~     number of pathological findings occur in liver in response to various insults that precede~     cirrhosis and are clinically important to identify such as steatosis associated with NASH,~     inflammation associated with viral hepatitis, and congestion associated with cardiac~     hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and~     treatment information but yet is not available non-invasively. Recent murine studies from~     this group of investigators has identified that MRE technology can be adapted to~     non-invasively detect these conditions. Implementing this into the practice will transform~     it by obviating the need for invasive liver biopsies in patients suspected of having such~     forms of suspected liver disease. This will differentiate Mayo from other institutions where~     such technology is not available.~      An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on~     the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of~     obesity. Recent evidence indicates a potential link between OSA and severity of NASH and~     fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in~     NAFLD is unclear. This study offers the unique opportunity to analyze this association, as~     the study population will undergo routine evaluation for OSA, as part as the preoperative~     work-up prior to bariatric surgery.~   "
37559|NCT02565433|"~     The aim of the study is to assess prospectively the impact of radiosurgery on the quality of~     life in patients with brain metastases.~   "
37585|NCT02565095|"~     It is well documented that a few days stay in space induces a change in the~     vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the~     disappearance of gravity. If the change of eye reflexes actually the result of a~     reinterpretation of sensory input, the investigators should also expect to see an alteration~     of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate~     the carotid baroreflex and thus participate in the post-flight cardiovascular~     deconditioning.~      The first objective of this project is to study the carotid baroreflex under different~     supine (dorsal, ventral and lateral) inducing different otolith stimulation in~     normal-gravity.~   "
37560|NCT02565420|"~     Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the~     other hand, saline administration maintains plasma osmolality and better repletes vascular~     volume which is an important goal of perioperative fluid administration. Currently, there is~     no convincing evidence that either saline or buffered solutions are preferable.~     Consequently, both types of fluid remain in common use at the Clinic and worldwide.~      There has never been a large trial of perioperative saline and balanced salt solutions~     comparing the incidence of major complications including acute kidney injury. The~     investigators primary objective is thus to determine the relative safety of perioperative~     saline and lactated Ringer's solution. Specifically, the investigators propose to test the:~        1. Primary hypothesis that a composite of major in-hospital postoperative complications is~          lower in patients given lactated Ringer's solution compared to normal saline.~        2. Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in~          patients given lactated Ringer's solution compared to normal saline.~      The acquisition cost of saline and lactated Ringer's solutions is similar in the United~     States. (Curiously, buffered solutions are far more expensive than saline in Great Britain.)~     But to the extent that one fluid or the other provokes more complications, cost of care may~     be increased with that fluid selection. Cost may also be increased by the need for~     additional electrolyte monitoring and electrolyte replacement.~      The investigators will therefore secondarily conduct an economic evaluation to determine the~     relative incremental hospital cost of each fluid. To the extent that one fluid or the other~     reduces cost (assuming similar complication rates), the Clinic will be able to reduce cost~     by specifying the appropriate fluid without impairing quality.~      Evidence that one fluid or the other causes few complications would be a strong quality~     indicator that the Clinic should standardize perioperative fluid selection.~   "
37561|NCT02565407|"~     This study investigates the effect of a robot-aided 2-day proprioceptive training of the~     wrist on the proprioceptive and motor function of the wrist/hand complex in patients with~     proprioceptive impairment. The wrist proprioceptive training consists of active movement~     training with augmented haptic and vibro-tactile feedback provided by a patented wrist~     robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety~     of clinical and non-clinical populations. The purpose of this study is to obtain preliminary~     data on the effectiveness of the proprioceptive training in subjects with cortical stroke or~     peripheral sensory neuropathy.~   "
37562|NCT02565394|"~     Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high~     physical and mental demands while enhancing performance during surgical procedures?~   "
37563|NCT02565381|"~     The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm~     pilot randomized controlled trial that will test the effect of 2 different experimental~     smoking cessation interventions relative to a control condition in homeless cigarette~     smokers. All participants will receive free transdermal nicotine patches and weekly~     in-person smoking cessation counseling. In addition, participants randomized to the first~     experimental condition will receive financial rewards for biochemically-verified smoking~     abstinence, and participants randomized to the second experimental condition will be~     enrolled in a text messaging program to support smoking abstinence.~   "
37564|NCT02565368|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers.~   "
37565|NCT02565355|"~     Recurrent Abdominal Pain (RAP) in children is common and causes significant functional~     impairment and poor quality of life. Lifestyle factors such as diet, anxiety, and stress are~     important triggers of abdominal pains, but there is lack of high quality research evidence~     on optimal treatment modalities in children. This study aims to evaluate the effect of food~     elimination on abdominal pain frequency and severity in a cohort of children with abdominal~     pain associated Functional Gastrointestinal Diseases (FGID). The primary outcome will be a~     comparison of abdominal pain frequency and severity between standard therapy and targeted~     food elimination, based on IgG antibody results to a multiple food antigen panel. The~     investigators anticipate that 'targeted dietary elimination' as a treatment strategy will~     resolve abdominal pain and improve quality of life in children.~   "
37566|NCT02565342|"~     The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks~     aimed at relieving pre- and post-operative pain include the superficial cervical plexus~     blocks, interscalene blocks and a combined version of the above. In this case study, the~     investigators aim to describe the protocol used in a university hospital: general~     anaesthesia with interscalene brachial plexus block, followed by optional iv morphine~     administration in phase 1 recovery and oral oxycodone on the ward.~   "
37567|NCT02565329|"~     The study aimed to evaluate the correlation between the serum lactate concentration ed~     cumulative Pringle time after liver resection. In addition, the correlation between lactate~     clearance and clamping time was investigated.~   "
37568|NCT02565316|"~     The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety~     herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial.~     A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz~     medical university, who having depression according to Persian‐language version of the Beck~     Depression Inventory‐Second edition and get score above 11 according to Persian version of~     Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly~     allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta~     menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and~     1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation,~     allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous~     suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and~     hypothyroidism and patients who used substances or alcohol and patients who had indication~     for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety~     Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd~     week, 4th week and then two weeks after the end of the intervention (in 6th week)~   "
37569|NCT02565303|"~     Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4~     intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected~     into subarachnoid space depends on the given dose and the chosen intervertebral space.~     Appropriate dose could satisfy the requirement of operation and reduce incidence of the~     adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in~     cesarean section through the two intervertebral spaces, respectively. This study is being~     conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in~     cesarean section.~   "
37570|NCT02565290|"~     The effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is~     well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3~     about changing this dynamic is not established. This study evaluate the relationship between~     supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third~     trimester. Women with gestational between 28 to 32 weeks will receive capsules of omega-3 or~     placebo, to be consumed daily for 3 weeks.~   "
37573|NCT02565251|"~     Severe sepsis and septic shock are among the leading causes of morbidity and mortality in~     patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the~     USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of~     this condition may lower the associated morbidity and mortality.~      The hemodynamic profile of the septic shock is characterized by the presence of the~     distributive shock, on which we can add elements from the hypovolemic and cardiogenic~     shocks.~      The objecive of this study is to optimize the volemic resuscitation of the severe septic and~     of the septic shock patient using two minimally invasive methods of hemdynamic monitoring~     which both use the same device (Edwards Lifescience). In the same time hemodinamic data will~     be colected by mesuring the inferior vena cava diameter.~   "
37574|NCT02565238|"~     The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data~     is collected to support the regulatory approval of this product in countries outside the CE~     region.~   "
37575|NCT02565225|"~     The purpose of this study is to evaluate the use, usability and feasibility of an~     Application (App) for patients with rheumatoid arthritis with diary functionalities, in~     patient-physician interaction.~   "
37576|NCT02565212|"~     The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory~     functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty~     patients with seasonal were included in this study. Patients were randomly divided into~     three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate~     therapy, group 2 received only montelukast, and group 3 only mometasone furoate. Patients'~     olfactory functions were determined using the Sniffin' Sticks olfactory test before and~     after a month treatments.~      Threshold, discrimination, identification, and TDI values were not significantly different~     among the groups before treatment. For Group 1 and Group 3 patients, there were~     statistically significant differences in threshold, discrimination, identification, and TDI~     values before and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2~     patients, the before and after treatment values of threshold, discrimination,~     identification, and TDI showed no significant differences (p > 0.05). According to the~     findings of our study, MF is superior to montelukast in improving olfactory function.~     Although montelukast has been shown to be effective against AR symptoms, its effect on~     olfactory function was not demonstrated in this study.~   "
37577|NCT02565199|"~     The goal of the study is to determine the effect of repetitive transcranial magnetic~     stimulation (rTMS) over the premotor cortex on training-related improvements in motor~     performance and associated neural plasticity.~   "
37578|NCT02565186|"~     This is a prospective, randomized, open-label study in subjects with migraine who have~     completed CoLucid Phase 3 study, COL MIG 301 or COL MIG-302. The study is designed to~     evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and~     of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of~     migraine. Long term efficacy will also be evaluated.~   "
37579|NCT02565173|"~     Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic~     formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or~     timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or~     Primary Open-Angle Glaucoma.~      All subjects who meet the study's enrollment criteria following Screening will undergo~     washout of all prohibited medications, including their routine glaucoma medications. During~     the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects.~     During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks~     followed by an Observation Period of approximately 7 days wherein no study eye drops are~     instilled.~      The purpose of the study is to assess the efficacy, tolerability, and safety of binocular~     topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for~     12 weeks.~      Timolol is being included in the trial in order to have an active control to ensure the~     integrity of the trial from an efficacy perspective; the primary comparator for all~     statistical purposes is the placebo arm.~   "
37580|NCT02565160|"~     Making the diagnosis underlying a painful, swollen joint currently involves aspiration~     followed by numerous microbiological and biochemical laboratory tests. This can be costly,~     time consuming and in the case of an acutely swollen joint, lead to a lengthy inpatient~     admission. There is an unmet need to provide a quick, easy, reliable dipstick like test to~     analyse joint fluid in the community, clinic, or emergency department setting.~      The investigators aim to use well established metabonomic techniques to:~        1. Analyse fluid from patients with swollen joints~        2. Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of~          joint swelling~        3. Correlate this with lubrication and wear properties of the fluid The long term goal is~          to develop time saving, cost effective, non-invasive diagnostic tests to improve~          management of a swollen joint. The biomedical research centre at Imperial provides a~          unique and unparalleled clinical and scientific environment to conduct this research.~          The Imperial College division of Computational and Systems Medicine has an~          international reputation in metabonomics and this, together with the high volume of~          patients with swollen joints treated at Imperial National Health Service Trust~          (c1000/yr) ensures that the study can take place in an environment conductive to~          success.~   "
37581|NCT02565147|"~     The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent~     of the damage done to the heart muscle in patients who suffered a heart attack, compared to~     the comparator treatment (heparin).~   "
37582|NCT02565134|"~     The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in~     male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID~     topical applications of PAC-14028 cream or vehicle for up to 4 weeks.~   "
37583|NCT02565121|"~     The aim of the study is to see whether patients with chronic smell impairment after brain~     injury benefit from a treatment that consists of corticosteroids, and then olfactory~     training in 3 months.~   "
37584|NCT02565108|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The blinded phase only will be described in this record. Participants will be randomized in~     a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of~     clobazam (CLB) and its major metabolite (N-CLB) may be altered (increased or decreased) as a~     result of using GWP42003-P.~   "
37586|NCT02565082|"~     Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid~     sequence of the β chain of hemoglobin.~      The most expressive and most frequent complication of the disease is vaso-occlusive crisis,~     dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic~     biological disturbances are observed in sickle cell patients.Sickle cell disease is~     considered nowadays as a hypercoagulable state.~      However, the approach used so far to the measure of clotting in sickle cell disease was~     segmented in the sense that the various components of the hemostatic balance were studied~     separately.The thrombin generation test is a functional test which explores the coagulation~     globally, integrating both pro players that anticoagulants actors in the system. The~     investigators already used this test to demonstrate that the hemostatic potential was high~     in a cohort of affected children compared to control children of the same age.~      This test will be used to characterize the hemostatic potential of adult sickle cell~     patients followed at the CHU Brugmann Hospital.~   "
37587|NCT02565069|"~     The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D~     Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the~     treatment of complex arrhythmias.~   "
37588|NCT02565056|"~     The purpose of this study is to assess the feasibility of conducting a trial to evaluate a~     self-help treatment for depression in people with end-stage renal disease.~   "
37589|NCT02565030|"~     This study will help to provide more up to date prognostic data on the natural history of~     untreated proximal CTEPH which will be helpful in discussions regarding surgical versus~     medical treatment and by exploring the similarities and differences between distal CTEPH and~     IPAH the investigators hope to get insights into disease mechanisms in patients with distal~     CTEPH.~   "
37590|NCT02565017|"~     The purpose of this study is to learn what cancer patients think about IBM Watson Oncology.~     IBM Watson Oncology is a computer program designed to help inform oncologists about the best~     chemotherapy choices for their patients. The investigators will conduct focus groups with~     cancer patients who have received chemotherapy treatment at MSK in order to understand~     cancer patients' thoughts about IBM Watson Oncology.~   "
37591|NCT02565004|"~     Background:~      DNA makes up the instruction book for people s cells. Cancer is a disease caused by DNA~     changes that build up and affect cell function. Researchers want to learn more about what~     may cause cancer by testing the DNA of people with the disease and their family members.~      Objective:~      To find DNA changes that may be inherited and may cause or influence whether a person gets~     cancer. To study families with clusters of cancer to find out if there is a DNA mutation~     specific to certain cancers.~      Eligibility:~      People 18 years of age and older who:~      Participated in the familial genetic part of NIH study 09-C-0079, a previous study or had~     family members enrolled in this study~      Design:~      Participants may have been screened in the previous study. They will give permission for~     researchers to use their data and their tissue or blood samples collected in the study.~      Participants may give blood samples.~      At each stage of testing, participants will meet with a genetics health care provider. The~     provider will explain the tests and answer questions.~      If researchers find a DNA change that might increase the risk for cancer or other health~     issues, they will confirm this result in a testing lab. This will require a blood sample.~      Participants personal DNA data and health information will be put in a database for research~     purposes.~   "
37592|NCT02564991|"~     Background:~      The way alcohol affects brain structure has been widely studied. But the way it affects all~     parts of the brain is still unknown. Researchers want to use magnetic resonance imaging~     (MRI) scans to study brain structure and function. They hope this will help them better~     understand changes that happen in brain regions during treatment of alcohol use disorders.~      Objectives:~      To study changes in the brain by using MRI in people with and without alcohol use disorders.~     To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how~     the brain recovers when alcohol use stops.~      Eligibility:~      People with alcohol dependence who are currently hospitalized in a particular unit at NIH.~      Healthy volunteers 30 60 years old without an alcohol use disorder.~      Design:~      Participants will be screened under a separate protocol.~      Participants will give a urine sample for a drug test and pregnancy test at each study~     visit. They will also have to pass a breath alcohol test.~      At the first visit, participants will have an MRI. The scanner is a metal cylinder in a~     strong magnetic field. Participants will lie on a table that slides in and out of the~     cylinder.~      They will do behavior and memory tasks outside the scanner.~      They will have gait and balance tested. They will have to stand on both legs, stand on just~     one leg, and walk in a straight line. They will perform each task with eyes open, then with~     eyes closed.~      They will have tests of memory, thinking, and problem solving.~      Some participants will have a second visit. They will have another MRI and repeat some of~     the behavior and memory tasks.~   "
37593|NCT02564978|"~     Background:~      Age-related macular degeneration (AMD) is the main reason older people lose their vision. It~     affects the macula, the center of the retina needed for sharp, clear vision. Researchers~     want to see if an antibiotic can help people with an advanced form of AMD, Geographic~     Atrophy (GA).~      Objective:~      To see if minocycline is safe for people with GA and if it helps preserve their vision.~      Eligibility:~      People age 55 and older who have GA in at least one eye.~      Design:~      Participants will be screened with physical exam, medical history, blood tests, and eye~     exam.~      Participants will be assigned to take either minocycline or placebo. They will take 1 pill~     twice a day for at least 3 years.~      Participants will have study visits every 6 months for at least 3 years. At each visit,~     participants will have a medical history. They may have:~      Blood tests.~      Eye exam. Vision, eye pressure, and eye movements will be checked. The pupils may be~     dilated. The inside of the eyes may be photographed.~      Their thyroid gland felt while they swallow.~      Microperimetry. They will sit in front of a computer and press a button when they see a~     light on the screen.~      Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. A dye~     called fluorescein will be placed in the IV and travel through the veins to the blood~     vessels in the eyes. A camera will take pictures of the dye as it flows through the eye~     blood vessels.~      Participants will be contacted by phone periodically between visits. They will answer~     questions on their visual function once every year.~   "
37594|NCT02564965|"~     The purpose of this study is to determine optimal treatment strategies for symptomatic~     walled-off pancreatic necrosis( WON).~   "
37598|NCT02564913|"~     In traditional Chinese medicine (TCM), examination of the tongue plays an important role in~     diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur,~     teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of~     the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia,~     which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing~     hyperglycemia can also be associated with buccal alteration. The purpose of this study was~     to survey on tongue diagnosis and other examinations associated with diabetic mellitus.~   "
37599|NCT02564900|"~     This is an open-label, two-part, multiple study to evaluate the safety and tolerability of~     DS-8201a in patients with advanced solid malignant tumors.~   "
37600|NCT02564887|"~     Patients with head and neck cancer treated with chemoradiation, often develop a treatment~     associated dysphagia. The common complaint is foods sticking in the pharynx. This study~     seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment~     induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal~     cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard~     exercise alone to determine if recovery is enhanced and to determine if rate of recovery is~     accelerated.~   "
37601|NCT02564874|"~     The objective of this study is to determine the effect different sources and forms of~     discretionary foods have on dietary compensation and energy intake in healthy adults in a~     free living, real world setting. Specifically, this pilot study will compare the effect of~     the greatest caloric sources of savory and sweetened discretionary foods in the American~     diet (savory snacks v. sugar-sweetened beverages). The rationale for conducting this study~     is to test the mechanism whereby sugar-sweetened beverages are hypothesized to relate to~     weight gain and obesity above and beyond other discretionary foods (lack of energy intake~     compensation due to liquid form of the beverage), since the evidence for this topic is~     limited. The subject population will be 20 men and women between the age of 18 and 59 who~     are overweight by body mass index (BMI ≥ 25 kg/m2), generally healthy, consume~     sugar-sweetened beverages or , and are willing to incorporate a sweetened beverage or a~     savory snack into their usual diet in the 4 week period.~   "
37602|NCT02564861|"~     This is a randomised, double-blind, placebo-controlled multiple dose study designed to~     explore the safety, tolerability and PK of DS-1971a following oral administration over 14~     days to healthy male and female subjects.~   "
37603|NCT02564848|"~     Eligible patients will be female age 70 or older and have a diagnosis of clinical T1-2N0 ER+~     invasive breast cancer. Patients will undergo standard of care lumpectomy without sentinel~     node biopsy followed by radiation and hormonal therapy.~      Sentinel node biopsy is also considered standard care when patients have localized breast~     cancer. Treatment can often be influenced by whether the results of the biopsy show cancer~     or not. However, the biologic factors of the primary tumor have become more important in~     determining treatment recommendations in women with estrogen receptor positive breast~     cancer.~   "
37604|NCT02564835|"~     The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga~     and to begin to assess whether yoga is effective in improving attention and immune function~     in individuals with colorectal cancer compared to physical activity and usual care.~   "
37605|NCT02564822|"~     The aim of this study is to investigate the motor and visual cortex excitability in response~     to visual stimulation of migraineurs with and without aura compared to healthy individuals.~     For this purpose, electrical cortical activity of migraineurs will be compared to healthy~     volunteers.~   "
37606|NCT02564809|"~     The investigators will conduct a 8-week proof-of-concept randomized controlled trial to~     provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a~     mobile cognitive training program -- on cognitive and brain plasticity in older adults. The~     investigators will also explore whether Fit Brains training paired with a brief bout of~     exercise would enhance the potential cognitive benefits of Fit Brains.~   "
37607|NCT02564796|"~     Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood~     cell levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and~     iron can prevent and/or decrease the amount of blood transfusions needed in this population.~     We seek to investigate if EPO and iron make a clinically significant difference in the~     number of transfusions given to these patients and the morbidity associated with it.~   "
37608|NCT02564783|"~     PURPOSE OF THE STUDY~      The main purpose of this study is to find out what is the true burden of surgical conditions~     in pediatric population in a well defined geographical rural area in western Kenya.~   "
37609|NCT02564770|"~     This is a cross-sectional, observational study examining the factors leading to the~     therapeutic decision to use MabThera (rituximab) in participants with RA. Routine~     rheumatology clinical practice data of participants who are being or have been treated with~     rituximab for RA will be collected and analysed in this chart review.~   "
37610|NCT02564757|"~     The investigators will examine if pregnancy increases risk of ventral hernia recurrence~   "
37611|NCT02564744|"~     A Multicenter Open-Label Phase 2 Study of IMGN529 in combination with rituximab in Patients~     with relapsed or refractory B-Cell lymphoma and Other Forms of Non-Hodgkin's Lymphoma.~   "
37612|NCT02564731|"~     This prospective cohort study is designed to observe of the effect of intervention therapy~     on the long-term prognosis of children with bronchiectasis. The main purpose of the study~     was to evaluate the degree of deterioration of lung function, to observe and compare the~     quality of life, the time of pulmonary exacerbation, and the changes of lung image.~   "
37613|NCT02564718|"~     The purpose of this study is to find out whether rivaroxaban is safe and effective to use in~     children age newborn to less than 6 months and how long it stays in the body and how it is~     used in the body. Safety will be assesed by looking at the incidence and types of bleeding~     events. There will also be a check for worsening of blood clots.~   "
37656|NCT02564146|"~     ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II~     trial with two arms.~      To estimate the treatment effect on overall survival, feasibility, efficacy and safety of~     alternating treatment cycles of gemcitabine monotherapy followed by~     nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles~     in first-line treatment for metastatic pancreatic cancer in patients having received 3~     cycles of induction therapy with standard nab-paclitaxel/gemcitabine.~   "
37614|NCT02564705|"~     The aim of this study is to compare outcomes and cost-effectiveness of anterior versus~     posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is~     to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry~     Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related~     adverse events. Secondary objectives are to compare treatments in terms of differences in~     pain, quality of life, health utilities, and need for re-operation. Finally, a~     cost-effectiveness analysis will be performed. This analysis will take the form of~     cost-effectiveness if there is a difference in treatment effects or cost-minimization if~     there is no difference in treatment efficacy.~   "
37615|NCT02564692|"~     The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large~     group of people interested in participating in research studies or clinical trials based in~     part on their genetic background. This genetic information will be used to match interested~     individuals to studies, providing a recruitment resource to the Alzheimer's scientific~     community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the~     GeneMatch program.~   "
37616|NCT02564679|"~     Pediatric obesity has become a critical health problem worldwide, increasing the premature~     onset of obesity-related morbidities. This phenomenon has induce an increase in the~     incidence of serious health complications starting in childhood and adolescence. Lifestyle~     interventions, including diet and regular physical activity, are the cornerstone of current~     medical management. Unfortunately, these interventions are often ineffective in providing a~     meaningful and long-lasting weight loss necessary to change health outcomes. It has been~     demonstrated that an early intervention in obesity in children and adolescents, inducing~     weight loss by performing bariatric surgery in carefully selected patients, can dramatically~     reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic~     fatty liver disease (NAFLD).~      Recent evidence suggest that bariatric surgery can improve metabolic complications and liver~     involvement in patients affected by morbid obesity.~   "
37617|NCT02564666|"~     Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects~     used as systemic treatment in patients with unresectable hepatocellular carcinoma.~      Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot~     be ignores.~      This drug occasionally causes severe adverse events (AEs), which include hand-foot skin~     reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although~     most adverse events are reversible, they can significantly impact a patient's quality of~     life and occasionally result in dose reduction or discontinuation of therapy Patients are~     also more likely to remain on treatment if they are guided over the difficult initial 4~6wks~     of therapy during which time the development of adverse events following sorafenib treatment~     initiation are most likely to occur.~      Patient education, proactive management and establishing and maintaining open communication~     between patients and the nurse are crucial to the effective management of these adverse~     events.~      This study design is a randomized controlled trial and 64 patients will be randomized to one~     of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the~     rest of 32 patients will be enrolled into the intervention group. The intervention group~     will be received the routine telephone calls of six times at intervals of once a week during~     10~15 minutes (from a well-trained nurse)~      The purpose of this study is to confirm whether an effective intervention that telephone~     counseling and education by a nurse can increase drug compliance for patients with HCC who~     is taking Sorafenib and is to use for developing individual educational program as a~     fundamental data that can be applied for patients taking Sorafenib after investigating~     patient satisfaction by The Satisfaction with information about Medicines Scale(SIMS)~     tool.~   "
37618|NCT02564653|"~     Vietnam has a smoking prevalence that is the second highest among South East Asian countries~     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest~     total number of adult smokers (over 16 million) in SEA. According to the World Health~     Organization (WHO), most reductions in mortality from tobacco use in the near future will be~     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.~     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is~     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of~     recommended care is suboptimal. The objective of this proposal is to fill the current~     research-to-practice gap by conducting a randomized controlled trial that compares the~     effectiveness and cost effectiveness of two practical and highly replicable strategies for~     implementing evidence-based guidelines for the treatment of tobacco use in public health~     clinics in Vietnam. The proposed implementation strategies draw on evidence-based~     approaches, and the WHO's recently released guidelines for implementing Article 14 of the~     Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that~     was developed by the WHO in response to the globalization of the tobacco epidemic. Vietnam~     ratified the FCTC in 2004; however, they have not taken steps to implement Article 14 which~     specifies the need to integrate best practices for treating tobacco use and dependence into~     routine preventive care. The proposed implementation strategies also build on the growing~     literature that supports the effectiveness of integrating community health workers as~     members of the health care team to improve access to preventive services.~   "
37619|NCT02564640|"~     Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might~     attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope~     needs comparatively less airway manipulation so, the investigators expect less hemodynamic~     response while using videolaryngoscope.~   "
37620|NCT02564627|"~     A prospective randomized study, including moderately obese patients will be included.~     Patients will be randomized in 3 groups:~        -  PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet~        -  PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet~        -  Only 1200Kcal/day diet~      The effect on appetite and weight loss will be investigated.~   "
37621|NCT02564614|"~     This open-label study will demonstrate proof-of-mechanism of HIF1A inhibition by a decrease~     of HIF1A mRNA after intravenous (IV) infusion of RO7070179 in participants with~     hepatocellular carcinoma (HCC) who have failed at least one line of systemic therapy. This~     will be a single arm study and all participants will receive RO7070179, 13 milligram per~     kilogram per week (mg/kg/week), 2-hour IV infusion on Days 1 and 4 during Week 1 of Cycle 1,~     followed by once weekly in 6 week cycle. Treatment with RO7070179 will be continued until~     disease progression or unacceptable toxicity.~   "
37860|NCT02561494|"~     Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the~     total intravenous anesthesia (TIVA).~      The investigators will evaluate whether the nefopam can decrease the total amount of~     remifentanil administered during the operation, which will reduce the acute opioid tolerance~     and following consumption of fentanyl during postoperative period.~   "
37622|NCT02564601|"~     This project evaluates the effects of piano training and computerized cognitive training on~     cognitive performance in healthy older adults compared to controls. The project is intended~     for healthy older adults (60-80 years) with little to no previous musical training (less~     than three years of prior musical training or cognitive training and not currently engaged~     in music reading or musical performance, less than 10 hours of previous cognitive training).~     Investigators anticipate that musical engagement will serve as an enjoyable cognitive~     intervention for older adults. Investigators believe that piano training will enhance~     cognitive performance on executive functions essential for maintaining independence in older~     adulthood. Learning a musical instrument, while challenging, will improve self-efficacy,~     mood, and qualtiy of life. Participants engaged in piano training will demonstrate reduced~     cortisol levels and increased immune function responses. Investigators predict that adults~     enrolled in computerized cognitive training will demonstrate enhanced memory, working memory~     and self-efficacy post-training.~   "
37623|NCT02564588|"~     Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with~     moderate to severe Binge Eating Disorder (BED)~   "
37624|NCT02564575|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the~     HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.~   "
37625|NCT02564562|"~     The study aims to understand, using radiolabelled PF-06463922, how this compound is modified~     by the body once it is absorbed. The study also aims to understand how much of the compound~     is broken down and how much leaves the body unchanged.~   "
37626|NCT02564549|"~     Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and~     targeted biopsies for men with low risk prostate cancer on active surveillance with any~     volume Gleason's Score 6, but no prior MRI imaging of the prostate.~   "
37627|NCT02564536|"~     For the first 28 day cycle, all patients will be treated with single agent pacritinib at 200~     mg twice daily. The investigators chose this starting dose based on the previous three phase~     I studies of pacritinib as a single agent which showed that the maximum tolerated dose (MTD)~     to be 500 mg, and subsequently, the dose of 400 mg daily was recommended for the phase II~     studies.~      Recently, the results of the phase III PERSIST-1 trial comparing pacritinib to best~     available therapy (BAT) in patients with MF was reported at the 2015 American Society of~     Clinical Oncology (ASCO) annual meeting. Pacritinib was found to be significantly more~     effective than BAT at reducing spleen volume at 24 weeks of therapy and improving~     constitutional symptoms.~      Low dose decitabine has demonstrated depletion of DNMT1 in normal hematopoietic stem cells~     (HSC) without cytotoxicity and subcutaneous (SC) instead of intravenous (IV) administration~     may avoid high peak levels that can cause apoptosis. Furthermore, the low toxicity~     associated with low dose decitabine would allow for more frequent (1 to 3 times weekly)~     administration of the drug which would catch more cells in S-phase via greater exposure~     time. Based on these findings, a starting dose of decitabine 5 mg/m2 SC twice weekly should~     be well tolerated and effective in patients with MF and MPN/MDS syndromes when combined with~     pacritinib 400 mg daily.~   "
37628|NCT02564523|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of three~     heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study~     will include healthy adults and elderly participants, HIV infected adults, healthy~     adolescents, children and young children.~   "
37629|NCT02564497|"~     The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept~     relative to Process C belatacept in Healthy subjects~   "
37630|NCT02564484|"~     This observational study is designed to establish induced pluripotent stem cells (iPSCs)~     from childhood cancer survivors who did or did not develop persistent treatment-induced~     peripheral neuropathy, from which to make human neurons for comparing their sensitivity to~     vincristine and other potentially neurotoxic drugs.~      Investigators will assess the effects of inherited genome variations on treatment-induced~     peripheral neuropathy that persists in adults who were cured of childhood cancer. Cells from~     childhood cancer survivors who did or did not develop drug-induced neuropathy will be~     isolated and induced to become neurons. Cell sensitivity to anticancer agents will be tested~     in both groups and compared to determine if the survivors have genetic variants that~     correspond to those identified in companion genomic studies. This will assist in determining~     if gene variants increase the risk of treatment-induced neurotoxicity.~      The investigators are interested in detecting changes of phenotype pre-post treatment in~     each group (cases, controls) respectively, as well in comparing the pre-post treatment~     phenotypic changes between the two groups (cases vs. controls).~   "
37631|NCT02564471|"~     This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune~     response generated by rabies vaccine when administered for post-exposure prophylaxis. This~     study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies~     immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis~     regimen.~   "
37632|NCT02564458|"~     Purpose: The primary hypothesis of this study is that the combination of interval exercise~     training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week~     intervention that will improve cardiorespiratory fitness in patients preparing to undergo~     allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but~     in respect to this study, MA refers to the use of wearable accelerometry paired with regular~     intervals of physical activity coaching from members of the study staff during the IET~     training. The study will also look at several secondary endpoints including the association~     of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor~     suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms~     and quality of life before and after transplant.~      Participants: 60 patients will be randomized into two groups, 30 in the intervention group~     consisting of both IET and MA, and 30 in the control group applying usual care and use of~     wearable accelerometry without motivational physical activity coaching.~      Procedures (methods): Results of this study will inform a randomized, multi-site study of a~     pre-transplant exercise intervention.~   "
37633|NCT02564445|"~     This is a 36-week, three-arm randomized, controlled trial using a team-based model to~     compare two weight loss programs to control. Each intervention will use insights from~     behavioral economics to leverage social incentives and gamification.~   "
37634|NCT02564432|"~     The purpose of this study is to investigate the clinical implementation of a new~     percutaneous prosthetic attachment system by determining the resident microbial ecology of~     the implant exit site and to simultaneously study the systemic and local stomal immune~     responses. This study will follow 10 patients implanted with percutaneous osseointegrated~     prosthetics (POPs) for a period of one year. Two state-of-the-art, pre- and post-surgery~     bacterial monitoring technologies will be used; these procedures are intended to facilitate~     the early prediction, detection, and treatment of infection, as well as to provide follow-up~     data that can potentially be used to advantageously manipulate the stomal microbial~     environment in future clinical trials.~      Commensal skin bacteria colonize all stomas. Colonization does not necessarily result in~     infection. Over time, the presence of this skin penetrating foreign object (implant) will~     cause measurable changes in the bacterial population (microbiota) at and around the POP exit~     site. It is anticipated that the evolving microbiota, in concert with measurable changes in~     the local and systemic cytokine responses, will reveal patterns associated with~     mutualistic-commensal bacteria and/or pathogenic bacteria related to the stages of chronic~     wound healing. These patterns could be used to determine the presence of a stable uninfected~     stoma or the progression of a stomal infection. Hopefully, this information will allow~     timely intervention to prevent infection, i.e. by detecting early stages of infection or~     discerning common patterns of stable mutualistic-commensal bacterial strains, effective~     intervention protocols (antibiotics, probiotics or manipulation of the stomal and skin~     microbiota) may be developed to avoid patient morbidity and assure implant survival.~   "
37635|NCT02564419|"~     In this study, investigators will show proof-of-concept that brain signals can be used in~     real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo~     surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the~     motor cortex. These electrodes implanted in the brain will enable bioelectrical data~     recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data~     will be~        1. either processed in the Activa PC+S; or~        2. off-loaded via the Nexus D communication device (Medtronic) to a computer.~   "
37636|NCT02564406|"~     Noninvasive ventilation represents the standard of care for patients with exacerbation of~     chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe~     forms of acute hypercapnic respiratory failure and patients must undergo endotracheal~     intubation and invasive ventilation to restore adequate gas exchange. Under these~     circumstances, patients may express a clear intention not to be intubated.The aim of this~     study is to retrospectively assess efficacy and safety of noninvasive ventilation-~     plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.~   "
37637|NCT02564393|"~     The study is defined in 3 stages of in vitro assays :~      Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.~      This is a transversal study in which we compare :~        -  Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of~          patients~        -  Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients~          and blood of control subjects~      Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify~     receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent~     transduction pathways calcium and PKC . It will be performed on control blood neutrophils.~      Phase 3: Analysis of cell death ( NETose )~      This is a transversal study that will analyze :~      the mode of cell death of neutrophils purified blood and sputum of patients and control~     blood neutrophils by flow cytometry and transmission electron microscopy .~   "
37638|NCT02564380|"~     A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance~     Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous -~     Non-Small Cell Lung Cancer (sNSCLC).~   "
37639|NCT02564367|"~     Multicenter trial in Germany:~      Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of~     Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the~     feasibility and tolerability of two different adjuvant S-1 treatment regimens in Caucasian~     patients and to determine the recommended dose for both treatment regimens.~   "
37640|NCT02564354|"~     Exploratory proof of concept study to determine whether intranasal administration of QR-010~     in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508~     mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator~     (CFTR).~   "
37641|NCT02564341|"~     The TEACH randomized controlled trial will test the effectiveness of a collaborative care~     intervention directed towards physicians who provide care for HIV-infected persons to~     improve the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce~     the misuse of prescription opioids among HIV-infected persons.~   "
37642|NCT02564328|"~     Stroke is a frequently occurring and common diseases in nervous system,and most of the~     survivors will remain disorders of motor,sensory and cognition function.Stem cell~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow~     mesenchymal stem cells in patients with chronic stroke.~   "
37657|NCT02564133|"~     Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation~     of a hip prosthesis may be complicated by intracardiac embolization of various origin.~      A patent foramen ovale exists in approximately one fifth of the population; it facilitates~     the passage of embolus from the right heart to the left one and then especially to the~     coronary vessels and to the brain.~      The hypothesis supported in this research is that the prevalence of postoperative~     complications, especially neurological ones, is increased after surgery for hip fracture~     when patients have a patent foramen ovale.~   "
37658|NCT02564120|"~     NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate~     cancer, who were enrolled from January 2011-June 2013. These patients were recruited~     throughout North Carolina, and also in partnership with institutions across the country.~     Patients enrolled before they start treatment, and are then followed prospectively through~     treatment and then afterwards. This observational study collects information on quality of~     life, cancer control, and health care received inclusive of treatment and management of~     subsequent effects including complications and recurrence. The objective of this study is to~     examine comparative outcomes among different modern prostate cancer treatment options in~     this cohort of patients.~   "
37643|NCT02564315|"~     Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking.~     This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - -~     an innovative multi-phase approach - - to test post-relapse treatments designed to assist~     smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR)~     treatments that are applied at two stages following relapse: 1) RR Preparation Phase~     treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase~     treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to~     quit smoking will make an initial quit attempt in the Quit Phase (cessation medication +~     counseling). Participants who relapse will be randomized to one of three RR Preparation~     Phase treatments (Behavioral [Smoking] Reduction Counseling + the Nicotine Mini-Lozenge;~     Recycling Counseling that encourages participants to quit again as soon as possible; and~     Preparation Phase Control). RR Preparation Phase participants (other than controls) who~     elect to try a new quit attempt will be randomized to one of four RR Cessation Phase~     treatments based on a 2X2 fully-crossed factorial design testing two factors: Supportive~     Counseling (vs. Brief Information) and Skill Training (vs. Brief Information). All RR~     Cessation Phase participants will receive 8 weeks of combination nicotine replacement~     therapy (nicotine patch + nicotine mini-lozenge). The investigators hypothesize that RR~     Preparation Phase Reduction treatment will significantly increase long-term abstinence rates~     relative to the Preparation Phase Control condition.~   "
37644|NCT02564302|"~     This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial~     Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are~     randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the~     treatment group obtains a device.~      Patients from both group will fill out a quality-of-life questionnaire at the time of~     enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately~     the effect of mindfulness using the headband will be evaluated in the aforementioned patient~     population.~   "
37645|NCT02564289|"~     The current study proposes to investigate the effects of chronic snus use on the blood~     vessels. Several cardiovascular endpoints are measured using various methods in healthy~     daily snus users as well as in healthy matched controls.~   "
37646|NCT02564276|"~     To determine the difference in the proportion of hemipelves with successful detection of~     Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging~     vs blue dye) in women with endometrial cancer.~   "
37647|NCT02564263|"~     In this study, participants with advanced or metastatic adenocarcinoma or squamous cell~     carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction~     (EGJ) that has progressed after first-line standard therapy will be randomized to receive~     either single agent pembrolizumab or the Investigator's choice of standard therapy with~     paclitaxel, docetaxel, or irinotecan. The primary study hypothesis is that treatment with~     pembrolizumab will prolong progression-free survival (PFS) and/or overall survival (OS) as~     compared to treatment with standard therapy.~   "
37648|NCT02564250|"~     The purpose of this study is to study longitudinal changes in maternal metabolism and~     pregnancy outcomes in obese pregnant women.~   "
37649|NCT02564237|"~     This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The~     study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one~     dosage (600 µg protein) in healthy adults 18 through 50 years of age.~   "
37650|NCT02564224|"~     Temporary stomas has been performed to reduce complications after colorectal cancer surgery,~     especially in high-risk anastomosis. Different closure technics showed different outcome.~     The aim of this study is to compare the VSS score , surgical site infection and pain score~     of pursestring wound closure vs conventional closure.~   "
37651|NCT02564211|"~     This is a study to assess the safety and efficacy of the addition of ipragliflozin to~     sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have~     inadequate glycemic control on sitagliptin, diet, and exercise therapy.~   "
37652|NCT02564198|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     ramucirumab in children with recurrent or refractory solid tumors including central nervous~     system (CNS) tumors.~   "
37653|NCT02564185|"~     According to the WHO, therapeutic education is intended to help patients acquire or maintain~     the skills they need to optimally manage living with a chronic disease. Low back pain is~     frequent and therapeutic education could be a promising option.~      The purpose of the study is to evaluate the impact of a therapeutic education program for~     patients suffering from low back pain.~   "
37654|NCT02564172|"~     Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has~     devastating effects on patient's quality of life. Today, 30% of patients are refractory to~     pain management and surgical procedure.~      The neuropathic characteristics of the pain in these patients lead us to test the efficiency~     of spinal cord stimulation at conus medullaris level.~      In our published preliminary study involving 27 patients with refractory pudendal neuralgia,~     we demonstrated that 74% of patients implanted with stimulation electrodes at the conus~     medullaris responded to stimulation.~      The primary objective of the present trial is to assess through a randomized, parallel group~     design, the effectiveness of spinal cord stimulation at the conus medullaris using~     pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on~     sitting time in refractory pudendal neuralgia.~   "
37655|NCT02564159|"~     Malnutrition is a major risk factor for morbidity and mortality of patients managed in~     intensive care unit. Early recognition and treatment of adult malnutrition are recommended~     in acute care settings especially for patients requiring mechanical ventilation. Biochemical~     indicators like serum concentrations of albumin and prealbumin (transthyretin) have a~     tradition of being used as markers of nutritional status but remains influenced by~     nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound~     method has gained interest for screening and follow-up of muscle weakness at the bedside in~     critically ill patients. The purpose of the study is to investigate the validity of~     ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit.~   "
37659|NCT02564107|"~     This study will evaluate the efficacy, safety, and effect on quality of life of oral~     ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The~     anticipated time on study treatment is 25 weeks, and the target sample size is 50~     individuals.~   "
37661|NCT02564081|"~     Recent research suggests that the skeletal muscles and the fibrous connective tissue form a~     body-wide network of myofascial chains. A systematic analysis of dissection studies suggests~     that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As~     fascia can modify its stiffness, strain transmission along these meridians is supposable~     (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to~     the proper functioning of the movement system. However, despite solid evidence from in vitro~     studies, scarce data is available concerning the in vivo behavior of the meridians. The~     present study is conducted to resolve this research deficit and to elucidate whether~     stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20)~     participate in the randomized controlled trial. One group performs three 30 s bouts of~     static stretching for the gastrocnemius and the hamstrings respectively. A control group~     remains inactive for the same time. Participants of the third group perform 6x30 s bouts of~     static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post~     intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM)~     in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement~     analysis system.~   "
37662|NCT02564068|"~     In human volunteers intranasal administration of oxytocin significantly increases~     parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease~     with high cardiovascular risk factors, yet this disease remains very poorly treated. This~     proposal, based on the current literature and new basic science results detailed above on~     the role of oxytocin in cardiovascular control, will test if oxytocin administration~     improves adverse cardiovascular events during the recurrent nocturnal apneas in patients~     with OSA. This project will lay the groundwork and provide preliminary data to obtain NIH~     funding to test this important hypotheses more thoroughly and in larger clinical trials.~      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in~     patients with sleep apnea.~   "
37663|NCT02564055|"~     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and~     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the~     topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this~     study will be considered when selecting the most appropriate concentration of GSK2894512~     cream and application frequency in future clinical studies. This is a multicenter (United~     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,~     6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic~     dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream~     will be equally randomized and evaluated following application to all atopic dermatitis~     lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for~     12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks~     double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject~     participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult~     males and females subjects with atopic dermatitis will be screened in order to have at least~     228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately~     204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to~     achieve at least 24 evaluable Japanese subjects.~   "
37664|NCT02564042|"~     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and~     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the~     topical treatment in subjects with plaque psoriasis. Results from this study will be~     considered when selecting the most appropriate concentration of GSK2894512 cream and dosing~     frequency in future clinical safety and efficacy studies. This is a multicenter (United~     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,~     6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and~     1%) and a vehicle control cream will be equally randomized and evaluated following~     application to all psoriasis lesions (except on the scalp) once daily (evening) or twice~     daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4~     weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The~     total duration of subject participation will be approximately 16 to 20 weeks. Approximately~     270 adult males and females subjects with plaque psoriasis will be screened in order to have~     at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and~     approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized~     in Japan to achieve at least 24 evaluable Japanese subjects.~   "
37665|NCT02564029|"~     PF-06372865 in subjects with photosensitive epilepsy~   "
37666|NCT02564016|"~     The goal of this study is to evaluate the effect of continuous postpartum epidural saline~     infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery~     following vaginal delivery.~   "
37667|NCT02564003|"~     The pharmacokinetics of oxycodone is well characterized in children older than six months of~     age. However, only one study has been published with children younger than six months,~     concluding that unexplained inter-individual variability is pronounced in the youngest~     children. The aim of the current study was to quantify oxycodone pharmacokinetics in~     children ranging from preterm newborn infants to children up to two years of age.~   "
37668|NCT02563990|"~     This is a prospective, randomized, single-blinded human clinical trial that will examine how~     injection pressure influences the spread of a given volume of injectate in the adductor~     canal, during adductor canal nerve block.~   "
37669|NCT02563977|"~     The purpose of this study was to perform an evaluation of the structural changes in the~     abdominal wall after harvesting a DIEP flap in breast reconstruction.~      15 women undergoing secondary, unilateral breast reconstruction were recruited to the study~     and underwent a 2 year postoperative CT scan of the abdomen (without contrast).~      Structural changes were assessed by comparing the abdominal CT scans performed prior to~     surgery with the 2 year postoperative CT scans.~   "
37895|NCT02561039|"~     This study will assess the efficacy and safety of ibandronate (Bondronat), administered~     intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate~     to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV~     infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky~     Performance Index (KPI) will be measured at intervals throughout the study. The anticipated~     time on study treatment is 4 months and the target sample size is 150 individuals.~   "
37670|NCT02563964|"~     Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be~     related to insufficient vulnerable plaque identification using invasive coronary~     angiography. Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time~     and their relation with biomarkers need further exploration. More accurate identification~     and assessing long-term behaviour of vulnerable plaques may improve therapeutic strategies~     and clinical outcome. The investigators hypothesize that fully integrated 18Fluoride~     Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging~     (PET/CMR) increases the ability to detect vulnerable plaques as compared to coronary~     angiography.~      This prospective study in 33 consecutive patients with NSTEMI aims to:~        1. Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive~          coronary angiography,~        2. Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with~          myocardial infarction using CMR, both at baseline and during follow-up,~        3. Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic~          events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial~          disease), and~        4. Examine the relation between vulnerable plaques and plasma biomarkers.~   "
37671|NCT02563951|"~     The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability~     of 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays~     (GNS) as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.~   "
37672|NCT02563938|"~     This first-in-human study will evaluate the safety and tolerability of single doses of AK001~     across a range of potentially active doses. Early signals of pharmacodynamic activity will~     also be evaluated.~   "
37673|NCT02563925|"~     The purpose of this study is to see if the combination of tremelimumab with brain radiation~     therapy can help treat this type of breast cancer that has spread to the brain.~   "
37674|NCT02563912|"~     Dosage errors are common in the stressful situation of a pediatric resuscitation. In~     addition to that, studies have reported that delays to provide medication is associated to~     worst survival rate for very sick children. To minimize delays and error, the investigators~     recently published a resuscitation handbook who provides drug dosages for each weight for~     children thus eliminating the need for dosage calculation. Once the weight of the patient is~     known, the physicians only have to open the book at the page corresponding to the weight and~     all the medications with their calculated dosage are provided. The primary goal of this~     study is to evaluate the number of dosage error during simulated pediatric resuscitation~     comparing residents using the handbook vs. utilisation of a chart providing non-calculated~     dosage. This will be an experimental crossover trial among 40 residents performing four~     simulated case-scenarios in a high-fidelity simulation lab.~   "
37675|NCT02563899|"~     This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo~     controlled study to assess the pharmacokinetic parameters, safety, tolerability, and~     clinical effect of topically applied umeclidinium following once daily topical~     administration to axilla for 14 days in subjects with primary axillary hyperhidrosis. This~     study will determine whether topically applied umeclidinium can decrease hyperhidrosis~     without systemic anticholinergic effects (ie. in the range or lower to those obtained after~     inhaled route) at the highest possible concentration.~      Subjects will be dosed by site staff each night immediately before bedtime for 14 days.~     Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS)~     measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic~     sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of~     the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately~     24 subjects.~   "
37676|NCT02563886|"~     The purpose of this study is to determine whether intensive, focused training of the~     affected upper extremity after stroke results in long-term functional gains in~     moderately-to-severely paralyzed patients, more than 6 months after their vascular accident.~     During the course of therapy, user's attempts to move and complete exercises are assisted by~     neuromuscular electrical stimulation.~   "
37677|NCT02563873|"~     The investigators are examining the relationship between heart rate and heart contraction in~     patients with heart failure and pacemakers, aiming to improve quality of life.~   "
37678|NCT02563860|"~     This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.~   "
37679|NCT02563847|"~     With this study the investigators investigate the effects of amino acids (tryptophan in two~     different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety~     mechanisms.~   "
37680|NCT02563834|"~     Studies of myocardial fuel selection using a novel palmitate-based PET probe~   "
37681|NCT02563821|"~     Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural~     Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via~     Continuous Epidural Infusion (CEI).~      Purpose : However, the superiority of PIEB compared to CEI has not been investigated for~     third trimester voluntary termination of pregnancy.~      We hypothesized that PIEB administration would result in a better degree of satisfaction of~     the patients compared with CEI for third trimester legally induced abortion analgesia.~   "
37682|NCT02563808|"~     The purpose of this study is to investigate the impact of incorporating anticipated regret~      into standard patient decision aids. Participants in the Wharton Behavioral Lab will be~     administered a standard patient decision aid and an anticipated regret augmented decision~     aid. Participants will complete a computerized survey about their experiences with each~     version, and their answers will be assessed for potential differences associated with the~     incorporation of Anticipated Regret.~   "
37697|NCT02563613|"~     In recent years, Hong Kong is undergoing rapid changes together with macro social and~     economic trends. The increasingly complex and diverse family structure is leading to a major~     concern in the well-being of families, including their health, happiness and harmony (3Hs).~     Family life and health education should be strengthened to meet the increasing needs of~     healthy lifestyle promotion. In light of these concerns, the Happy Family Kitchen Movement~     (HFKM) project, with a focus on FAMILY Holistic Health, will be conducted at~     territory-wide level in Hong Kong. HFKM is a community-based research project to develop,~     implement and evaluate a community-based family intervention program for improving family~     well-being. It is expected that participants of the community-based family interventions~     will gain knowledge on family holistic health and in turn promote a healthy lifestyle for~     3Hs.~   "
37683|NCT02563795|"~     Anesthesia for cesarean section requires special importance because it may affect both~     mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the~     primary objective during anesthesia. Even though many factors influence sensory nerve block~     for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that~     influence the sensory nerve block is the obesity related to pregnancy. Due to the~     enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural~     space reduces, so the local anesthetic requirement also reduces. Many investigators~     recommend lower dose of local anesthetic in obese patients due to reduced requirement There~     are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been~     found. Investigators have designed this study to see the effects of conventional dose (10 mg~     bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and~     normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen~     provides surgical anesthesia in obese patients while avoiding maternal hypotension.~   "
37684|NCT02563782|"~     To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection~     prophylaxis prior to and/or following transplant of MA09-hRPE cells.~   "
37685|NCT02563769|"~     The main purpose of this study is to determine if it is safe to use the study drug,~     clavulanic acid, in combination with cocaine. In this study, subjects will receive~     intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic~     acid is being studied so future studies can be done to find out if this drug is helpful in~     treating cocaine dependence. Currently, there is no available medication treatment for~     cocaine dependence.~   "
37686|NCT02563756|"~     Patients with medial gonarthritis are randomised to a unicompartmental or a total knee~     replacement.~      Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by~     CT Secondary aims: functional tests, gait analysis, health related quality of life and~     patient related outcome.~   "
37687|NCT02563743|"~     Purpose~      Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden,~     resulting in suffering for the individual and financial costs for the employer as well as~     for society at large. Studies on interventions that address stress and mental ill-health and~     that focus on sick leave and return to work (RTW) show little or no effect of commonly used~     methods such as medication or psychological approaches. Furthermore, these interventions~     often focus on the individual's symptoms without considering their work situation. The~     occupational health services (OHS) has knowledge of the employee's work environment and can~     offer treatment facilitating the employee's RTW and improving the employee's work ability~     while taking into account both the individual and the work situation. The intervention in~     the current study will be performed at the OHS.~      The study aim is two-fold: first, an intervention that addresses both individual and~     workplace related aspects among employees with work-related CMD:s and/or stress related~     symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on~     sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence~     to the intended treatment and associations with the outcome of the intervention will be~     assessed.~   "
37688|NCT02563730|"~     A multicenter, multinational, prospective study to clarify, whether the addition of~     cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients~     with suspected Idiopathic Interstitial Pneumonia~   "
37689|NCT02563717|"~     Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with~     new system (low imposed work of breathing and prongs) reduce the frequency of delivery room~     intubations compared to standard treatment with T-piece resuscitator system (high imposed~     work of breathing and face mask)?~      Trial summary: This is a randomised controlled trial of delivery room intubation rates~     comparing a new system and T-piece resuscitation system for initial stabilisation of infants~     born <28 weeks.~   "
37690|NCT02563704|"~     The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate~     with three quinine regimens in the treatment of severe malaria in children at the Ebolowa~     Regional Hospital located in the South region of Cameroon~   "
37691|NCT02563691|"~     This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in~     conjunction with hormone therapy for patients with metastatic prostate cancer where there~     are a limited number of metastatic tumours.~   "
37692|NCT02563678|"~     In this small pilot study, participants (patients and healthy volunteers) will have blood~     drawn before and after the study intervention (hyperbaric chamber session or normal pressure~     oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine~     analysis.~   "
37693|NCT02563665|"~     All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients~     with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at~     the dialysis unit of ILBS.~   "
37694|NCT02563652|"~     Patients undergoing major surgery are exposed to extensive damage of tissues, which induces~     widespread activation of the inflammatory system, called 'systemic inflammatory response~     syndrome' (SIRS).This activation of the inflammatory system may induce instability of the~     heart and respiration in the postoperative period. The degree of physiologic response to~     postoperative SIRS as well as the degree of postoperative pain differ between patients.~     Therefore, patients undergoing anesthesia and major surgery are treated in a 'post~     anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The~     time patients need to stay in a PACU after major surgery has not been extensively studied,~     and more appropriate tools for prediction of length of stay are needed.~      The main aim of this study is to assess whether clinical observations, inflammatory~     biomarkers or genetic markers may aid in the prediction of physiological instability and/or~     pain after major surgery. Such predictors would help clinicians planning the length of~     PACU-stays.~   "
37695|NCT02563639|"~     Objective of the registry is to assess the use of antithrombotic therapies and adherence to~     guidelines in patients with non-valvular atrial fibrillation.~   "
37696|NCT02563626|"~     International registry gathering patients with angiographically confirmed coronary aneurysm.~   "
37924|NCT02560649|"~     The aim of current study is to investigate whether the HBsAg clearance rate can be improved~     if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis~     B) patients treated by nucleoside analogue(NUC) achieved HBVDNA<1000copies/ml，and~     HBsAg<5000IU/ml; &HBeAg<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.~   "
37698|NCT02563600|"~     Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will~     be randomly divided into three groups:~        -  a group that gets a telephone call before their invitation letter is sent.~        -  a group that gets a telephone call after their invitation letter is sent.~        -  a group that does not receive a telephone call.~      The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind~     the patient of their appointment time, it will outline what the treatment involves and~     highlight the potential benefits and drawbacks, and allow the patient to ask questions about~     the treatment.~   "
37699|NCT02563587|"~     The purpose of this study is to determine the efficacy of laughter therapy in children to~     improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital~     stay.~   "
37700|NCT02563574|"~     This study is being done to learn about the interaction of alcohol consumption and HIV on~     brain function. The proposed study will have two broad objectives. The first is to~     incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic~     Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and~     cerebral metabolic disturbances affecting specific functional brain systems that are~     associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency~     Virus (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients~     with heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other~     neuroimaging measures compared to moderate drinkers and people who do not drink at all. The~     second objective is to examine the extent to which reductions in ETOH consumption among~     heavy drinkers with HIV infection result from a motivational intervention. The findings from~     this study will provide important information on how heavy ETOH and HIV interact to affect~     the brain functional responsiveness, and the extent of improvement that might be gained by~     reducing heavy ETOH use.~   "
37701|NCT02563561|"~     This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind~     study of apaziquone in patients with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in~     diameter, all of which must have been fully resected at TURBT.~      In addition to Screening, patients will undergo an assessment of urothelial carcinoma of the~     bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.~      Following TURBT on Day 1, eligible patients will be randomized to one of three treatment~     arms in a 1:1:1 ratio:~      Arm 1 : One dose of Apaziquone~      Arm 2 : Two Doses of Apaziquone~      Arm 3 : Placebo~      Primary endpoint is to evaluate the Time to Recurrence with either a one instillation of 4~     mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation~     following TURBT in patients with non-muscle invasive bladder cancer (NMIBC) who receive~     transurethral resection bladder tumor (TURBT).~   "
37702|NCT02563548|"~     This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab for subjects~     with relapsed/refractory advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have~     failed at least 1 platinum-based chemotherapy regimen and subjects with relapsed/refractory~     locally advanced or metastatic gastric adenocarcinoma after failing at least 1 chemotherapy~     regimen.~   "
37703|NCT02563535|"~     The aim of this study is to evaluate the potential advantage in terms of late lumen loss~     reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in~     the treatment of below-the-knee disease in patients with critical limb ischemia.~   "
37704|NCT02563522|"~     This study will assess the safety and efficacy of using gene therapy via intramuscular~     injections of the calf for patients with chronic non-healing foot ulcers.~   "
37705|NCT02563509|"~     Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients,~     so the viruses could not massively replicate when HAART was discontinued, then make HIV~     functional cure possible.~   "
37706|NCT02563496|"~     This is a prospective, open-label, multicenter, non-comparative, single arm study of~     pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of~     age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for~     P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines.~     Sites will have up to 48 hours to obtain consent. Once full consent is provided, all~     subjects will be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose~     on Day 1. All study medication should be taken with food. After the treatment period,~     subjects will attend up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and~     120). The main cohort will consist of subjects aged >=2 years to <16 years with no~     restriction on gender. Subjects will be dosed according to four weight bands. Within the~     total of 60 enrolled pediatric subjects, a second cohort of up to 6 infants aged >=6 months~     to <2 years (weighing >=5 kilogram [kg]) will be recruited following completion of a planned~     first interim analysis. An interim analysis will be conducted once sufficient data from 16~     subjects is available to assess pharmacokinetic (PK) and safety parameters. If needed, a~     second interim analysis will be conducted after a total of 32 subjects have enrolled. The~     primary objective of this PK bridging study is to adequately characterize the systemic TQ~     exposure in the pediatric population.~   "
37707|NCT02563483|"~     This study evaluates the effects of the practice of yoga in combination with compassion~     meditation on the quality of life, attention, vitality and self-compassion of family~     caregivers of patients with Alzheimer's disease.~   "
37708|NCT02563470|"~     In this retrospective registry trial, the investigators sought to assess the incidence and~     predictors of cardiovascular and cerebrovascular complications as well as their derivatives~     (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation~     requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism)~     in cohort of patients undergoing head and neck surgery.~   "
37709|NCT02563457|"~     This study will assess the efficacy of periodontal treatment in diabetic patient. Patients~     will be randomized in the periodontal group or in the control group. The control group will~     received a periodontal treatment after the study.~   "
37710|NCT02563444|"~     The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in~     the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by~     comparing the path indicated by the ultrasound fusion (virtual line) and the path actually~     obtained on the control CT scan (real line).~      Compared with ultrasound guidance alone or CT scan alone, the results are expected to be~     more accurate, saving time and irradiation (not evaluated here).~   "
37711|NCT02563431|"~     About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This~     common occurrence is a cause for concern in the rehabilitation setting as it leads to~     impairment of functional outcomes induced by discomfort and delays in rehabilitation,~     important psycho-emotional repercussions as there is a correlation between upper arm pain~     and depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can~     ultimately give rise to type 1 complex regional pain syndrome (CRPS I). There is no~     consensus on treatment, care pathways or useful devices for positioning acute stroke~     patients in the literature. Our objective is to compare the effectiveness of a new~     positioning procedure of the hemiplegic arm with conventional positioning (pillow and~     shoulder-immobilisation sling) in acute stroke patients.~      Patient's actions are focus in 4 points:~        -  Positioning in bed, wheelchair and standing with specific materials (holds, sling in~          external rotation and abduction)~        -  Be careful of shoulder's coaptation in care and functional activities (toilet,~          dressing, transfers)~        -  A training of the patient and members of family on pathology, risk, use of material~        -  Daily passive mobilisation of the upper member by a therapist.~   "
37712|NCT02563418|"~     The purpose of this study is to know the limits of feasibility of a reliable oculomotor~     record for patient with Huntington's disease.~   "
37713|NCT02563405|"~     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor~     for stroke and cardiovascular events. Accumulated data has shown that target-organ damage is~     related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in~     subjects with essential hypertension. There are many studies about the effects of different~     kinds of drugs on blood pressure, but the clinical researches about the impacts of~     antihypertensive drugs on BPV are limited, and the conclusion is still controversial.~      In addition, recent studies found that the occurrence and development of hypertension,~     especially essential hypertension, are closely related with hyperuricemia. Serum UA is an~     independently prognostic indicator for the development of hypertension. Some studies have~     observed the effects of different kinds of antihypertensive drugs on uric acid level in~     hypertensive patients. After adjustment, calcium channel blockers are associated with a~     lower risk of incident gout among people with hypertension. However, the effects of alpha~     blockers on uric acid in plasma are still not very clear.~      Therefore, we performed this study to observe the different effects of alpha blocker and~     calcium channel blocker on blood pressure variability and uric acid level in hypertensive~     patients.~   "
37714|NCT02563392|"~     Hysterectomy is an effective treatment used as a first-line approach for uterine myomas.~     Several others alternatives to hysterectomy have been developed in recent years for women~     wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.~      Myomectomy, particularly through minimally invasive surgery, is currently considered the~     conservative treatment of choice for patients wishing to preserve their fertility. However,~     three important issues should be considered: the risk of intra- and postoperative bleeding,~     the risk for recurring myomas, and the preservation of subsequent fertility.~      Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to~     avoid bleeding and improve uterine suture. Another expected long-term benefit is the~     improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However,~     the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age~     has not yet been studied, which limits its clinical application.~   "
37715|NCT02563379|"~     The goals of our study are to determine a).the association between abnormal circadian BP and~     the development of paroxysmal AF in hypertensive patients, b).at which level of TOD,~     paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association~     between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart~     rate during a 24-hr interval is associated with the development of paroxysmal AF, and~     finally e).examine the relationship between a wide PP and asymptomatic AF episodes in~     patients with HTN.~   "
37716|NCT02563366|"~     This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal~     stem cells (BM-MSCs) can promote function recovery in patients with poor early graft~     function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD~     kidney transplant recipients with poor early graft function (with or without dialysis) post~     transplant are equally randomized into MSCs group or control group. Patients in MSCs group~     are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given~     intravenously for four consecutive doses every week after enrollment. Patients in control~     group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival~     and severe adverse events up to 12 months post enrollment are monitored.~   "
37717|NCT02563353|"~     Objective:~      This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard~     parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body~     vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV~     stimulates muscles and bones. A combined treatment might have synergistic or additive~     beneficial effects on bone, reducing fracture risk making treatment more effective and~     cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve~     fracture risk even further.~      If the results of this pilot study are promising then a strong case can be made for a large~     multi-centre RCT using strong endpoints including fractures and falls.~   "
37718|NCT02563340|"~     This study is designed to investigate the efficacy and safety of allogeneic bone~     marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection~     (cAMR) after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria~     2013 based on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR~     patients are assigned to MSCs group or control group. Patients in control group are~     prescribed to current desensitization therapy including at least one of the following~     treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib,~     depending on individual pathological and immunological features (eg. DSA type and titer) of~     each study subjects. Patients in MSCs group receive additional BM-MSCs therapy besides~     desensitization treatments as in control group. Allogeneic BM-MSCs (1*10^6/kg) are~     intravenously administered every two weeks for four consecutive doses. All cAMR patients are~     followed up for one year. Renal function, DSA level, pathological features, patient/graft~     survival, and severe adverse events are monitored during the follow-up period. Immunological~     features of patients in both groups are consecutively examined.~   "
37719|NCT02563327|"~     The Tuberculosis Trials Consortium (TBTC) phase 3 treatment trial, Study 31, will~     investigate the efficacy and safety of daily rifapentine (1200 mg daily) with or without~     moxifloxacin as part of multidrug treatment regimens for drug-sensitive pulmonary TB. The~     proposed study (Study 31 PK/PD) will examine the population pharmacokinetics and~     pharmacodynamics (PK/PD) of high-dose daily rifapentine with and without moxifloxacin given~     for 17 weeks. Two different PK sampling procedures are required for the population PK/PD~     assessments involving rifapentine and moxifloxacin: (1) intensive sampling of 6~     samples/participant on one occasion plus subsequent sparse sampling for a subset of Study 31~     participants who are invited to co-enroll in Study 31 PK/PD; and (2) sparse sampling of 2-3~     samples/participant for all other Study 31 trial participants (these data will be collected~     as part of the Study 31 treatment protocol). Herein, we describe the PK sampling to be~     conducted among those Study 31 participants who are co-enrolled to Study 31 PK/PD (n=60).~     Intensive PK sampling is needed in some participants to estimate the population PK model~     parameters with no bias and satisfactory precision (relative standard error < 20%). PK and~     outcomes data from all participants in Study 31 will be merged to build the population PK/PD~     models to evaluate PK/PD parameters. Details regarding these planned analyses are also~     provided in this Study 31 PK/PD protocol.~      Primary Objectives:~        1. Characterize the population pharmacokinetics of rifapentine and 25-desacetyl~          rifapentine, using sparse PK data from Study 31 and intensive PK data from Study 31~          PK/PD. Using the population PK model, determine post-hoc Bayesian estimates of~          individual-level PK parameters.~        2. Examine the relationship between rifapentine PK parameters of interest and treatment~          efficacy. PK parameters will include area under the concentration time curve (AUC0-24),~          peak concentration (Cmax), time above the mean inhibitory concentration (MIC), and~          AUC/MIC. The treatment outcome of interest will be time to culture conversion and time~          to treatment failure or relapse.~           Secondary Objectives:~        3. Among the Study 31 participants in the lowest 10% for rifapentine AUC0-24, examine the~          PK/PD effect on culture conversion of sputa after completion of 4 months of daily~          rifapentine therapy.~        4. Examine the relationship between safety outcomes (Grade 3 or higher adverse events) and~          rifapentine PK parameters (AUC0-24, Cmax, AUC0-24/MIC and time above MIC).~        5. Characterize the population PK of moxifloxacin, and then estimate moxifloxacin AUC0-24~          and Cmax when moxifloxacin is administered with rifapentine given at a daily dose of~          1200 mg.~        6. Examine the relationships between moxifloxacin PK and treatment outcomes (as described~          in objective 2 for rifapentine) and moxifloxacin PK and safety (as described in~          objective 4 for rifapentine).~      Design:~      In Study 31 PK/PD, among 60 participants with tuberculosis enrolled in a rifapentine-based~     treatment arm of Study 31, PK data will be collected on two occasions. At TBTC sites that~     have the capacity to perform this activity, participants will have 6 scheduled PK samples~     per participant collected to measure rifapentine (with or without moxifloxacin)~     concentrations over approximately 24 hours. In addition among these 60 participants, 2 to 3~     scheduled PK samples will be obtained on a second late sampling at > 14 days after the~     first PK sampling.~   "
37720|NCT02563314|"~     Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are~     at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2~     retention is believed to be reversal of preexisting regional hypoxic pulmonary~     vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical~     ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention~     with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled~     oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and~     improve both urinary output and renal function.~   "
37721|NCT02563301|"~     Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is~     maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a~     potential solution. The relatively short radius of the blade curvature combined with the~     internal arrangement of optimal components means that the glottis can be seen without the~     need for alignment of the oral, pharyngeal and tracheal axes.~      The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view~     of the larynx in patients with limited neck movements, making intubation quicker, easier and~     possibly safer.~   "
37722|NCT02563288|"~     Patients undergoing intracranial procedures may experience severe hypertension and~     tachycardia due to intracranial hypertension and to increased release of adrenaline.~     Preventing perioperative sympathetic activity is of great importance. A common technique is~     using b-blockers like esmolol, which effectively block perioperative hemodynamic changes~     during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a~     component of a balanced anesthesia during neurosurgical procedures. This study aimed to~     evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing~     elective craniotomy with fast track neuroanesthesia.~   "
37723|NCT02563275|"~     The aim of this project is to investigate whether alterations in sensory-motor performances~     during weightlessness are only of theoretical relevance, or indeed restrict the capacity of~     the participants. To find out, volunteers will monitor a complex realistic process by~     operation of buttons and switches in weightlessness. The task will mimic the control of~     vehicles, research equipment and industrial processes. Effects of weightlessness will be~     separated from effects induced by stress and those of motivation through evaluation of~     cortisol and manipulation of motivation.~   "
37724|NCT02563262|"~     The scientific goal of this experiment is to evaluate the performances of our~     three-dimensional digital model by comparing its prediction computed from underwater data to~     posture observed during real weightlessness during parabolic flight.~   "
37725|NCT02563249|"~     If investigators know that the anticipatory mechanisms involved in precision grip take into~     account the gravity, however it is unclear how they adapt to changes in the gravitational~     level. The objectives of this study are to study and model the movement control and the~     mechanisms underlying learning and adapting to the condition of weightlessness.~     Specifically, i) investigators will determine if a change in the level of gravity is taken~     into account when controlling grip force and ii) investigators will examine the effects of~     gravity change on hand-eye coordination.~   "
37726|NCT02563236|"~     During a space mission the crew has to perform a wide variety of tasks under different~     acceleration conditions. For handling of displays and control items during a mission, the~     astronaut's performance is strong depended on an intuitive usability. Currently~     investigators are exploring and developing different Augmented Reality interfaces for the~     International Standard Payload Rack (ISPR) Biolab that is installed in the International~     Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect,~     view of a physical, real-world environment whose elements are augmented by~     computer-generated sensory input such as sound, video, graphics or GPS data. Using AR~     technologies provides user-oriented support for working procedures in development,~     production, and operating of complex technical products and systems. It is conceivable that~     in future manned missions such interfaces will be applied to space operations, where the~     astronaut will handle virtual information that enriches the physical reality. To improve the~     support for the operational ground team and the space crew by performing service and~     maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative~     tridimensional (3D) interaction techniques that allow an intuitive way to interact with the~     virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support~     while handling standardize service and maintenance procedures. This research is primarily~     focused on supporting the ground team during their work at the engineering model of Biolab~     that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces~     subsequently to space operations requires previous exploration regarding the influence of~     different acceleration conditions that ought to be considered at the investigators' current~     stage of designing and development. Thereby one important aspect is focused on the correct~     placement of virtual user interfaces while interacting with it. To explore human adaption of~     handling and controlling virtual AR interfaces, this experiment denotes a usability study~     that will supply findings about human mental workload and sensorimotor coordination while~     performing the experimentation task under different accelerations of gravity. The proposed~     experiment will supply essential information about understanding the adequate quality~     characteristics concerning placement of virtual interfaces in physical reality and identify~     disturbing factors while applying in hyper-g and micro-g conditions.~   "
38060|NCT02558868|"~     This study is a randomized, open-label, controlled study that will compare the efficacy of~     oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for~     patients with gemcitabine and S-1 refractory pancreatic cancer.~   "
37727|NCT02563223|"~     In this project, investigators propose to study the jump in different reduced gravity fields~     obtained during parabolic flights profiles but also during increased gravity fields obtained~     during turns of the airplane or during the pull-up phase of the parabola. By means of a~     pneumatic device, an additional pull-down force will be added to the vertical force caused~     by the gravity field. By combining different levels of gravity to different levels of the~     added pull-down force it will be possible to dissociate the respective contribution of the~     otolithic and proprioceptive systems to the anticipatory landing response. To the~     investigators' knowledge, only one study has modified the gravity field during a jump.~     However, these authors did not add a pull-down force and only analyzed the vertical ground~     reaction force.~      A better knowledge of the sensory-motor control of the landing phase of a jump will also~     increase the investigators' understanding of the physiopathology of joint instability.~     Indeed, similarities could be found between the evolution of the motor response due to the~     absence gravity during long-duration space flights and the pathological process of chronic~     ankle and knee instability. The knowledge generated by this study will thus provide~     invaluable information in the context of human performance and rehabilitation.~   "
37728|NCT02563210|"~     In preschool aged children, the most suitable techniques to assess airway obstruction is~     debit interruption technic (Rint) and plethysmographic measure of specific airway resistance~     (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung~     tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems~     to be better for discriminating airway obstruction. These two techniques will be compared in~     terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.~   "
37729|NCT02563197|"~     Study should show feasibility of the device for drug delivery into the lung independently of~     the severity of impaired lung function.~   "
37730|NCT02563184|"~     To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent~     influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of~     GOLD Stage C and D COPD vs. those patients without COPD.~   "
37731|NCT02563171|"~     Our objective in this case-control intervention study, therefore, was to explore the effect~     of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with~     chronic periodontitis in order to determine the usefulness of vaspin and omentin as a~     diagnostic and prognostic biomarker of periodontal disease.~   "
37732|NCT02563158|"~     The study aims to compare the perioperative and long-term outcomes of liver resection for~     HBV-related HCC with versus without hepatic inflow occlusion.~   "
37733|NCT02563145|"~     The purpose of this study is to determine whether real-time fMRI feedback is effective in~     the treatment of aggressive behavior problems in adolescents with high callous unemotional~     traits when compared to treatment as usual.~   "
37734|NCT02563132|"~     Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain,~     bloating and flatulence) after the procedure. So far, it has not been studied in~     inflammatory bowel disease patients. The study was designed to evaluate discomfort after the~     carbon dioxide insufflation colonoscopy in comparison to standard air insufflation~     colonoscopy.~   "
37735|NCT02563119|"~     Studying obesity and metabolic syndrome attention is focused more and more on gut~     microbiota. In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to~     alterations of gut microbiota, which seem to be favourable. In this study the investigators~     aim to examine the effect of different bariatric procedures on composition of gut~     microbiota.~   "
37736|NCT02563106|"~     A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004~     Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in~     Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract~     Infection (LRTI).~   "
37737|NCT02563093|"~     The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016~     formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults~     18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and~     Fluzone High-Dose vaccines in adults ≥ 65 years of age.~      Primary Objective:~      - To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone~     Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the~     2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65~     years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent~          and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the~          immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone~          High-Dose vaccines in adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone~          Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the~          applicable age group with the historical requirements of the Committee for Human~          Medicinal Products (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal~          Products (CPMP) - CHMP NfG CPMP/BWP/214/96.~   "
37738|NCT02563080|"~     Severe pancreatitis induces more damage in the pancreas and might therefore result reduced~     exocrine function leading to the insufficiency. The aim of this prospective study is to~     investigate development of pancreatic exocrine insufficiency in patients recovering from~     first attack of moderately severe or severe acute pancreatitis.~   "
37739|NCT02563067|"~     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared~     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA~     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all~     patients with severe asthma)~   "
37740|NCT02563054|"~     This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus~     5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with~     advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at~     least 6 weeks and continued up to disease progression, and the target sample size is 300~     individuals.~   "
38061|NCT02558855|"~     The primary aim of this study is to examine how different physical therapy interventions~     affect the resting state and contraction state of a certain abdominal muscle in patients~     with low back pain.~   "
37741|NCT02563041|"~     BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed~     for patients without definitive vascular access. However, CVC use is associated with~     complications such as infection, thrombosis, and dysfunction, leading to higher mortality~     and expenditures. The aim of this study was to compare the effectiveness of 30% trisodium~     citrate (TSC30%) with heparin as CVC lock solution in preventing catheter-related~     bloodstream infections (CRBSI) and dysfunction in hemodialysis patients. METHODS:~     Randomized, double-blind controlled trial comparing the event-free survival of non-tunneled~     CVC locked with heparin or TSC30% in adult hemodialysis patients.~   "
37742|NCT02563028|"~     Spine surgery in the prone position (which involves lying face down) is associated with~     various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent~     blindness. Known risk factors include low blood count (anemia) and long surgical times in~     the prone position under general anesthesia. While blindness is a rare outcome of this~     surgery, it is devastating and incompletely prevented by controlling known risk factors.~     Thus, improved monitoring and detection of visual injury during surgery is necessary. The~     purpose of this study is to determine whether a novel, non-invasive monitoring device can~     reliably record visual responses during spine surgery. The first phase of this study is~     completed and involved patients undergoing microdiscectomy surgery. The second phase of this~     study involves patients undergoing single-level lumbar spine decompression/fusion surgery.~   "
37743|NCT02563015|"~     One in four infants are born with low amounts of vitamin D stored in their body. This study~     is designed to test whether improving vitamin D status quickly after birth helps infants to~     build muscle and to normalize growth. This is important since the investigators have noticed~     in previous work that infants with low vitamin D have higher body weight relative to body~     length later on and that those who develop very good stores quickly have a leaner body type.~     Therefore, in this study infants with low stores early after birth will be given either the~     regular amount of supplementation or a higher amount to more rapidly build up the vitamin~     stores in the body. Infants in both groups will be measured for muscle and fat mass at~     standardized ages during the first year of life and into the toddler years. The information~     will inform health care professionals and parents of the importance of establishing good~     vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is~     already recommended for all term born infants. Knowing how much is needed in infants born~     with low stores has not been tested in a controlled manner in Canada.~   "
37744|NCT02563002|"~     In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be~     randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6~     standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal~     carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free~     survival (PFS) compared to current SOC chemotherapy.~   "
37745|NCT02562989|"~     The purpose of this 2-part open-label study is to investigate the safety and efficacy of~     [18F]MK-6240 as a Positron Emission Tomography (PET) imaging agent for quantifying brain~     burden of neurofibrillary tangle (NFT) pathology. Brain NFT deposition is a pathology~     finding in Alzheimer's Disease (AD), and density of brain NFTs has been shown to correlate~     with severity of cognitive impairment in AD. The objectives of the study include performing~     the following with respect to [18F]MK-6240 administered as a PET imaging agent: assess~     safety and tolerability; determine radiation safety profile; determine optimal imaging~     protocol parameters for quantification of brain NFTs in AD; compare tracer binding in brain~     PET scans from participants with AD of varying severity, participants with amnestic mild~     cognitive impairment (MCI) and healthy elderly participants; and evaluate intra-subject~     test-retest (T-RT) variability of tracer uptake in brain regions of interest. The primary~     efficacy hypothesis is that the intra-subject T-RT variability in brain regions associated~     with NFT deposition in AD is ≤10%.~   "
37746|NCT02562976|"~     The aim of the present study was to evaluate characteristics of background mucosa in early~     gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.~   "
37747|NCT02562963|"~     Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK~     phenotype. Our hypothesis is that Natural killer T cells may decrease the tumor burden and~     improve overall survival. The purpose of this study is to determine whether Natural killer T~     (NKT) cells are effective and safe in the treatment of patients with unresectable advanced~     solid tumor.~   "
37748|NCT02562950|"~     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of~     GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy~     male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2~     occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with~     GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day~     11).~      Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with~     midazolam in healthy male subjects will be evaluated.~      A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.)~     GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg~     (500 mg b.i.d.) GLPG1837.~   "
37749|NCT02562937|"~     The primary purpose of the current study was to determine whether a text message~     intervention would increase break frequency and length of break from sitting, time spent~     standing, and time spent in light and moderate intensity physical activity in university~     students~   "
37750|NCT02562924|"~     This study will assess the effectiveness of MEDIHONEY® sinus rinses (alone or in combination~     with intranasal corticosteroids) vs. intranasal corticosteroid sinus rinses on mucosal~     healing and polyp recurrence in the post-operative period following functional endoscopic~     sinus surgery.~   "
37783|NCT02562495|"~     Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of~     mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of~     muscle loss. This is a serious pathology associated with high morbidity and mortality.~      Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic~     Resonance Imaging (MRI) are considered as gold standards to quantify and monitor changes~     in muscle mass. But these tools are not adapted to ICU patients.~      Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not~     expose the patient to additional radiation.~      The objective of this study is to evaluate the correlation between US and CT scan to measure~     quadriceps muscle thickness of ICU patients.~   "
37751|NCT02562911|"~     In the general population, age of puberty, and age of menarche in girls, are closely~     correlated with those of their mother. The severity of chronic disease has an impact on the~     stature, the weight gain and the onset of puberty: age of menarche is even later that~     chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of~     children.~      Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore~     currently have a very specialized and early care. Older patients were diagnosed during~     childhood. The optimization of the nutritional and respiratory management has allowed over~     the past two decades a significant improvement in the survival of these patients. Most young~     people reach adulthood, puberty and reproductive desire are a crucial issue in the care of~     these young adults.~      In literature, it is often noted an age of menarche delayed an average of 2 years compared~     to the general population, but correlated with the age of menstruation from the mothers.~      The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are~     poorly known and there are few data on the characteristics of cycles. The menstrual~     irregularity and amenorrhoea episodes concern nearly half of women.~      On the pathophysiological level, studies in animals show that there is a direct effect of~     CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and~     reproductive capacity in mice.~      The literature data on the pubertal development, fertility and hormonal profile of these~     girls are for studies with low numbers and are very old. There is to date no French cohort~     study on this topic.~      The study is a multicenter cross-sectional descriptive study for pubertal and gynecological~     characteristics in girls followed annually in the reference centers Cystic Fibrosis two~     inter-region.~   "
37752|NCT02562898|"~     Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with~     metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in~     treatment is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be~     tumor promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B~     cells, results in increased CD8+ T cells to assist in tumor control. Preclinical studies of~     ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in~     both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered~     mouse models. Thus, the investigators propose a clinical trial of ibrutinib plus the~     standard gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety,~     then efficacy and including correlative studies.~   "
37753|NCT02562885|"~     Background: Close relationship exists between sleep slow wave (SSW) and the generation of~     spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between~     excitatory depolarization (Up-phase of the SSW) and inhibitory hyperpolarization~     (Down-phase of the SSW). It has been shown experimentally that with increasing synchrony~     of slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in~     correspondence to the SSW Up-phase enhance the amplitude of the subsequent SSW.~     Conversely, tones delivered at the SSW Downphase have a disruptive effect on the following~     SSW.~      Participants: Patients with epilepsy and spike waves in NREM-sleep.~      Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep~     by acoustic pulses applied at the Up- or Down-phase of SSW.~   "
37754|NCT02562872|"~     The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265~     including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.~      The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).~   "
37755|NCT02562859|"~     The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the~     blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given~     as an oral suspension under fasted conditions as well as a tablet formulation under fasted~     and fed conditions, in male healthy subjects.~      Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral~     suspension under fasted conditions as well as a tablet formulation under fasted and fed~     conditions, will be assessed.~      Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an~     oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be~     separated by a wash-out period of at least 6 days.~   "
37756|NCT02562846|"~     It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and~     sooner than antidepressants in the treatment of certain subtypes of depression. Given this~     effectiveness, it would be unfortunate not to give ECT to patients with good response~     chances as this could substantially shorten the length of a severe depressive episode.~     Instead of going through all possible psychopharmacological treatment steps, ECT could be~     proposed much earlier as a treatment option for those patients who might have good response~     chances. This would be a great advantage for the severely depressed patient, with a~     decreased disease-burden and hospitalization duration.~      However, up to now, objective and reliable predictive factors for good ECT response have not~     yet been established. Clinical characteristics such as psychomotor retardation, psychotic~     features and age have often been used to predict the outcome of ECT, but there is too little~     evidence to consider these as strong predictive factors.~      The current project is designed to allow better prediction of ECT-response. The investgators~     base their selection of predictors on clinical impression and previous research results. The~     predictive capacity of psychomotor functioning, psychotic symptoms and several biomarkers~     will be investigated. With these clinical and biological patient and depression~     characteristics, the investigators aim to develop a decision making tool that will allow a~     more accurate indication of ECT.~      The investigators also investigate ways to predict whether or not a patient will have a good~     response when treatment has already started, based on an early improvement of psychomotor~     functioning.~      Another subject of great importance is predicting and preventing side-effects. When patients~     at risk for lasting cognitive side-effects can be identified early in the treatment course,~     treatment can be adjusted to prevent persistence of memory problems. Therefore, the second~     part of the study focuses on identifying people at risk for cognitive side effects early in~     the treatment course.~   "
37757|NCT02562833|"~     The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a~     self-management and exercise program specific for elderly with knee osteoarthritis (OA),~     with the goals of managing OA symptoms, improving physical fitness, and developing~     self-efficacy and self-management of pathology.~   "
37758|NCT02562820|"~     Rett Syndrome (RTT) is a complex disorder resulting from mutations in a gene encoding the~     MeCP2 protein. Currently, there are no methods to fix the abnormal gene, however, animal~     studies suggest that the symptoms of RTT can be treated.~      Ketamine is a sedative or anesthetic, depending on the dose. The drug is approved by the US~     Food and Drug Administration (FDA) and is commonly used in children and adults. Animal~     studies and case reports in humans suggest that ketamine may reduce the symptoms of Rett~     syndrome. The purpose of this study is to determine the safety and efficacy of ketamine for~     treating breathing and behavioral symptoms of RTT.~   "
37759|NCT02562807|"~     The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic~     of TAS-303 in female patients with Stress Urinary Incontinence.~   "
37784|NCT02562482|"~     This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the~     safety and immunogenicity of a 2 injection vaccine Chikungunya virus (CHIKV) and virus like~     particle vaccine (CHIKV VLP) in healthy adults.~   "
38089|NCT02558491|"~     The purpose of this study is to demonstrate the safety and feasibility of a decision support~     system aimed at reducing glucose variability in T1DM patient using an insulin pump.~   "
37760|NCT02562794|"~     This study will use CBPR mixed methods (qualitative and quantitative data collection) to~     conduct needs assessments and design and evaluate a core family-based intervention. Project~     activities will emphasize capacity building in two refugee communities resettled in Greater~     Boston—the Somali Bantu and the Bhutanese—actively engaging refugee community members,~     community advisory boards, services providers, and other stakeholders. Specific Aims are to:~     (1) deepen partnerships with the Somali Bantu and Bhutanese communities through~     co-leadership, capacity-building, and knowledge sharing; (2) collect and apply qualitative~     data to (a) prepare a needs assessment of mental health in children and adolescents,~     barriers to care, and services preferences with each target refugee group; (b) develop~     mental health/psychosocial assessments for refugee caregivers and children; (c) adapt the~     core components of a family-based strengthening intervention for use with refugees; and (3)~     conduct an 80-family pilot study to examine acceptability and sustainability of the~     intervention. Key outcomes will be reduced mental health symptoms among children and~     adolescents and improvement in caregiver-child relationships.~   "
37761|NCT02562781|"~     Patients undergoing vascular surgery are at a significantly high risk of perioperative~     cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery.~     This could be because of co-morbidities that are common in this patient group. Additionally,~     smoking, which is common in this population, may be a contributing factor.~      Oxygen therapy has been used for decades in order to reduce the risk of myocardial~     infarction and stroke in patients undergoing vascular surgery and pre-existing~     co-morbidities in the belief that increased inspired oxygen increases oxygen delivery to~     tissues, thereby reducing the risk for hypoxia and cell death. However, several studies~     published recently have questioned the routine use of high inspired oxygen concentration~     (hyperoxia) to improve oxygen delivery, specifically in the neonatal period but possibly~     even following myocardial infarction. This could be explained by the fact that increasing~     inspired concentrations of oxygen cause vasoconstriction in cerebral and coronary arteries,~     thereby reducing blood flow. Additionally, increased oxygen causes excessive production of~     reactive oxygen species (ROS), and repercussion injury from oxidative stress. The latter can~     lead to apoptosis (cell death) in myocardial or cerebral neurons. Despite the high risks of~     administering oxygen when not needed, it is routinely used in hospitals all over the world~     without a doctors prescription.~      This study aims to assess peri-operative complications up to 1 year following vascular~     surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2~     98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).~   "
37762|NCT02562768|"~     This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.~      Part A will include healthy participants. Each participant will receive daily doses of~     LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day~     stay in the clinical research unit (CRU) and follow-up.~      Part B is contingent on the results of Part A. Part B will include participants with~     Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for~     14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and~     follow-up.~      Both Part A and Part B will require screening within 30 days prior to the start of the~     study.~   "
37763|NCT02562755|"~     This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based~     immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with~     sorafenib in patients with advanced hepatocellular carcinoma who have not received prior~     systemic therapy.~   "
37764|NCT02562742|"~     This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir,~     SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the~     safety and efficacy of SOF administered in combination with ribavirin under real world use~     in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and~     treated with SOF+ribavirin in routine clinical use, the primary objective of this study is~     to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.~   "
37765|NCT02562729|"~     The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1~     radical hysterectomy in cervical cancer.~   "
37766|NCT02562716|"~     This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and~     oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and~     paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients~     with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as~     fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and~     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. It is not yet known whether combination chemotherapy is more effective~     than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation~     before surgery in treating pancreatic cancer.~   "
37767|NCT02562703|"~     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as~     primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve~     Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive~     episode.~   "
37768|NCT02562690|"~     Impaired thrombotic status is associated with adverse cardiovascular events. Patients with~     acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is~     to determine the usefulness of thrombotic status assessment in a large cohort of ACS~     patients, managed with contemporary treatments, to identify patients at risk of thrombosis~     and those at risk of bleeding complications.~   "
37769|NCT02562677|"~     This is a phase II, open-label clinical trial. This clinical trial has as primary objective~     to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for~     elderly patients with moderate / severe depressive episode.~   "
37785|NCT02562469|"~     A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with~     ADHD. ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see:~     www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e.,~     sustained attention, working memory (WM), response inhibition, speed of information~     processing, cognitive flexibility and control, multiple simultaneous attention, category~     formation, and pattern recognition and inductive thinking).~   "
37770|NCT02562664|"~     Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a~     prevalence ranging between 6% to10% based on the National Institutes of Health (NIH)~     criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%.~     Typically, PCOS can identify during the early adolescence. Insulin resistance is a common~     finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype~     involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles~     are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by~     velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the~     intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition~     of its more common connection to obesity and insulin resistance allows for diagnosis of~     related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary~     syndrome. Significant improvements in ovulation and pregnancy rates as a result of~     clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported~     in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological~     approach to induction of ovulation in women with PCOS is clomiphene citrate~   "
37771|NCT02562651|"~     The purpose of the study is to investigate the changes of myocardial biomechanics and~     efficacy of doxycycline in patients with primary anterior STEMI.~   "
37772|NCT02562638|"~     Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive~     cardiac procedures. There exists neither clear evidence nor guidance about the benefits of~     this.~      The investigators aim to assess if there is a reduced incidence of vasovagal complications~     (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR,~     participant satisfaction if participants are not kept fasting.~      This (pilot) randomised control trial will have an intervention arm allowing participants to~     drink clear liquids freely up to 1 hour before the procedure versus keeping them~     traditionally NPO.~      240 patients will be randomised with 120 participants in each arm.~   "
37773|NCT02562625|"~     Around 13,000 participants are diagnosed with melanoma in the UK each year and that number~     is growing quicker than any other cancer. About 20% of participants will see their cancer~     return following their initial treatment and at present would survive a median time of 912~     months. In recent years, the development of new effective drugs has revolutionised the~     treatment of advanced melanoma, However, response rates are still low and new therapeutic~     approaches are needed.~      This is a phase II study to look at the effectiveness and safety of the combination of a new~     drug called pembrolizumab plus radiotherapy compared to pembrolizumab alone. The purpose of~     this study is to see if the addition of radiotherapy to pembrolizumab is better than~     pembrolizumab alone by measuring how long these treatments can control the growth of the~     cancer. Also it will assess if by adding radiotherapy the investigators can see its effects~     not only in the tumour that has had radiotherapy but also in other tumours in the rest of~     the body.~   "
37774|NCT02562612|"~     The purpose of this study is to collect response and pharmacokinetic data on the oral~     administration of a cocktail combination of 4 drugs being developed for the indication of~     metastatic breast cancer.~   "
37775|NCT02562599|"~     The purpose of this study is to evaluate the efficacy and safety of raltitrexed and~     cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and~     cisplatin in patients with locally advanced nasopharyngeal carcinoma.~   "
37776|NCT02562586|"~     The goal of this study was to compare early results of Total Hip Replacement (THR) in 2~     groups of patients: with and without closed suction drainage (CSD). Patients were followed~     for 3 months post operatively.~   "
37777|NCT02562573|"~     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050~     800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome.~      A total of 12 patients will initially be enrolled for study participation. A Data Safety~     Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When~     the 12 patients have completed at least one month of study treatment, the DSMB will meet and~     determine whether additional patients may be enrolled or the study should be stopped. If the~     safety is deemed acceptable to continue with the study, the study will enroll a maximum of~     36 patients.~   "
37778|NCT02562560|"~     The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in~     assessing three episodic memory's abilities (mental simulation throught the future, and the~     past, the learning of personnal actions i-e the enactment effect). Secondary goal is to~     describe the neuronal substrates associated to the alteration of theses abilites in TGA.~   "
37779|NCT02562547|"~     This is a retrospective data-only study following the phased introduction of the HEM-AVERT®~     Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on~     the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in~     labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and~     to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean~     Section during labor and delivery.~   "
37780|NCT02562534|"~     The aim is to create a database including recordings of ECG data recorded in an MRI~     acquisition~   "
37781|NCT02562521|"~     The purpose of this study is to evaluate a smoking cessation program for employees at the~     Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and~     3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation~     intervention at the work site.~   "
37782|NCT02562508|"~     This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by~     Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the~     immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in~     girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to~     the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the~     difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).~   "
37811|NCT02562131|"~     Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent~     prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high~     molecular sensitivity of PET in a single imaging session. The aim of this study is to~     evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for~     detection of recurrent prostate cancer.~   "
37786|NCT02562456|"~     The aim of this randomized clinical trial study is to compare the longevity of ART using~     high viscosity GIC and conventional treatment using composite resin in posterior primary~     teeth. As secondary outcomes, cost-efficacy and patient's self-reported discomfort will also~     be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or~     occlusal-proximal cavity will be randomly assigned in two groups according to the dental~     treatment - ART with high viscosity GIC (experimental group) or composite resin restoration~     (control group) -, which will be performed at dental care trailer located in a Educational~     Complex in Barueri/SP, Brazil. The unit of analysis for randomization will be the child. A~     number of 240 teeth presenting occlusal cavities and 188 teeth presenting occlusal-proximal~     cavities were set after sample size calculation. The groups will still be stratified~     according to children's caries experience. The primary outcome will be the restorations'~     longevity, which will be assessed after 6, 12, 18 and 24 months by two examiners through~     clinical examination of treatment according to Frencken and Holmgren (2001) criteria for~     occlusal cavities and Roeleveld et al. (2006) criteria for occlusal-proximal ones. The time~     spent during the dental treatment and all materials used will be considered for estimating~     the cost-efficacy of each treatment. The individual's discomfort will be also measured after~     each dental procedure using the Facial Scale of Wong-Baker.~   "
37787|NCT02562443|"~     The study's primary objective [in a population of patients with MDS after failure of~     treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival~     (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients~     and in a subgroup of patients with IPSS-R very high risk.~   "
37788|NCT02562430|"~     In summary, the proposed research is novel with respect to design, technology, and its~     multi-level integration probing psychological and neurobiological constructs assumed to be~     crucially implicated in placebo response and has significant clinical and research~     implications for the future. Specifically, the future implications include: 1)~     identification of biomarkers and biosignatures of placebo responders, 2) new possibilities~     to understanding and manipulating the system, 3) possibly decreasing or eliminating a major~     confounder in clinical trials and drug development, and 4) refining treatments with novel~     drugs that decrease (in clinical trial) or increase (in clinical practice) the placebo~     response.~   "
37789|NCT02562417|"~     Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular~     block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure~     against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone~     may impair the reversal effect of sugammadex. The objective of this randomised controlled~     trial is to confirm in the clinical practice these preliminary results.~   "
37790|NCT02562404|"~     This study is an observational study designed to determine the extent of gastrointestinal~     (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial~     fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA~     procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the~     administration of a questionnaire. The purpose of this study is to determine if vagus nerve~     injury resulting from RFCA for AF increases the risk of post-procedure GI complications that~     may present as temporary or permanent symptoms.~   "
37791|NCT02562391|"~     The aim of this study is to assess the effect of left atrial appendage excision on atrial~     fibrillation recurrence and incidence of stroke in patients with persistent and~     long-standing persistent atrial fibrillation undergoing surgical ablation.~   "
37792|NCT02562378|"~     The primary goal is to determine the maximum tolerated dose (MTD) of the combination of~     T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients~     previously treated with taxanes and trastuzumab-based therapy.~      In addition, pharmacokinetic data on the combination of T-DM1 and lyposomal doxorubicin will~     be obtained.~   "
37793|NCT02562365|"~     Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence~     after first line of therapy by optimal cytoreductive sugery and 6-8cycle of TP chemotherapy.~     We developed an adjuvant chemotherapy of three steps (ACTS). It is adding CTX+VP-16(second~     step)6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this~     study is to verify the effectivity and safety of ACTS.~   "
37794|NCT02562352|"~     In an aging population, most seniors suffer from multiple chronic conditions. When the~     number of medications taken is ≥5 (polypharmacy), the burden of taking so many together can~     do more harm than good. This study will test a program focused on medication reduction~     involving patient, pharmacist and physician using current technology aimed at reducing the~     harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions~     between them involves prioritizing the most important ones according to the patient's~     preference and stopping those which may no longer be necessary. Reducing the dose also~     reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications,~     will randomly receive the program immediately or at 6 months. The program involves~     information gathering from the patient, medication review with the pharmacist and then a~     consultation with the family doctor focused on discontinuing/reducing the dose of~     medications where possible using a 'pause and monitor' framework to assess the need for~     restart. An electronic program that detects drug adverse effects and flags potentially~     inappropriate medications will be integrated into a clinical pathway incorporating~     monitoring and follow up systems. This study will examine effects on patient and health~     relevant outcome measures as well as patients' and clinicians' experiences of the program.~     The results will be used to determine whether this system can be implemented as part of~     routine preventative care in older adults.~   "
37795|NCT02562339|"~     This is a prospective study that will examine psychosocial improvements among CF adolescents~     and caregivers going through the Stress Management and Resiliency Training - Relaxation~     Response Resiliency Program (SMART-3RP).~   "
37905|NCT02560896|"~     Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought~     to proceed when the research participant in a biobank is deceased and there is clinically~     relevant information that could be disclosed to family members. This study is designed to~     test a procedure offering genetic information to family members of research participants who~     participated in a pancreatic cancer biobank in a Health Insurance Portability and~     Accountability Act (HIPAA) -compliant design.~   "
37796|NCT02562326|"~     This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an~     individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes~     mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro~     compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of~     multiple daily dose administrations for 14 days. Each subject will be randomised to a~     sequence of two treatments, either BioChaperone insulin lispro-Humalog® or~     Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an~     individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be~     determined at the screening visit. During the outpatient phase the subjects will keep their~     basal insulin constant (except changes for safety reason). They will self-measure blood~     glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per~     outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial,~     2 hours post-prandial and at bedtime).~   "
37797|NCT02562313|"~     This study is constituted of 2 parts:~      Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will~     participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion~     (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company).~     Each treatment period consists of 10 treatment days under free living conditions (e.g. home~     / workplace) and under standardised conditions at the clinic. Various assessments for~     pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are~     performed on selected days, including:~        -  Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the~          post-prandial glucose response for 6 hours after individualized standard meal (fixed~          nutrient ratio) ingestion and bolus administration via CSII.~        -  Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode~          (i.e. neither subjects nor the investigators are aware of the sensor glucose values).~        -  Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the~          Investigational Medicinal Products (IMP) during the outpatient periods.~      Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period~     cross-over study aiming at comparing the performance of BC Lispro and Humalog after a~     prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and~     Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump~     compatibility and safety will be analyzed.~      Each period will include a mixed meal tolerance test with a CSII device and a mixed meal~     tolerance test with the same dose of insulin administered with a syringe.~   "
37798|NCT02562300|"~     Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality~     worldwide and that is according to the estimates of the World Health Organization in 1998.~     Average blood loss during delivery progressively increases with the type of delivery,~     vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml)~     of blood.~      A reduction of operative blood loss at cesarean section has a great benefit to the patients~     in terms of decreased postoperative morbidity and a decrease in risks associated with blood~     transfusions. The routine use of oxytocin is associated with a significant reduction in the~     occurrence of postpartum hemorrhage.~      Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by~     need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of~     cesarean births.~      Although many delivery units use oxytocin as the first line agent to prevent uterine atony~     at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage~     especially in compromised patients with preeclampsia, cardiac disease or prolonged labor.~     Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has~     negative inotropic, antiplatelet and antidiuretic effects.~      Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective~     myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.~      Misoprostol administration, either by oral or rectal route, has been shown to be effective~     in prevention of postpartum haemorrhage and is considered as an effective alternative to~     other conventional oxytocics especially in developing countries as it is cheap and~     thermostable.~      Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual~     administration was higher than those after oral or vaginal administration.~      A few studies are now available for the use of sublingual misoprostol in the prevention of~     postpartum haemorrhage following vaginal delivery and have reported it as an effective and~     convenient route of administration.~      However, none of the studies conducted so far have evaluated the response of sublingual~     misoprostol for prevention of postpartum haemorrhage during cesarean section.~   "
37799|NCT02562287|"~     The clinical use of clozapine has been an unequivocal advance in the treatment of~     schizophrenia, a chronic and severe mental illness. A wealth of clinical data demonstrates~     it offers enhanced efficacy on both positive and negative symptomatology, improving~     cognition, functioning and quality of life. It is also associated with improved compliance~     and a continued efficacy in long-term treatment that can be translated into a reduction of~     suicidality and all-cause mortality. Because of preclinical evidence that it modulates~     neuroplasticity and prefrontal cortex connectivity, clozapine may be an interesting strategy~     for further severe psychotic illnesses. Nevertheless, even considering the growing use of~     other atypical antipsychotics in the management of bipolar disorder, a role for clozapine~     has been poorly defined. The clinical evidence-base for its use in this condition is largely~     based on uncontrolled naturalistic trials and retrospective studies and chart reviews.~     Several of these have supported clozapine's efficacy in treatment-resistant bipolar~     disorder. Possibly because of clozapine's profile of adverse effects and lack of interest~     from pharmaceutical companies, only two randomized trials have examined its effectiveness.~     Both suggest clinically relevant antimanic and mood-stabilizing properties. Therefore, the~     primary objective of this trial is to determine the effectiveness of clozapine for~     treatment-resistant bipolar disorder. Secondary objectives include examining the effects of~     treatment with clozapine on cognition and functioning of patients with bipolar disorder.~     Tolerability and safety of long-term clozapine use will also be examined. To that end, the~     investigators will conduct a clinical trial with 54 patients with a history of treatment~     resistance. Patients will be randomized to either open-label treatment with clozapine, in~     combination with lithium or valproate, or open-label treatment with an atypical~     antipsychotic with consistent evidence of efficacy in the treatment of bipolar disorder~     (olanzapine, quetiapine or risperidone), also in combination with lithium or valproate.~     Patients will be followed for one-year and time to all-cause treatment failure will be the~     primary outcome measure. It is the belief of the investigators that this study will generate~     meaningful clinical data of tremendous importance to validate clozapine as a legitimate~     treatment option for treatment-resistant bipolar disorder.~   "
37800|NCT02562274|"~     This study the investigators aimed to determine the effect of the herbal porridge containing~     the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and~     bone formation markers of menopausal women. Forty-five participants were randomly assigned~     to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.~   "
37843|NCT02561715|"~     Anosognosia is a recognised condition for people with Parkinson's, and is the result of~     physiological damage on brain structure.~      Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the~     pre-surgery videos 12 months post-DBS, patients have forgotten and are shocked at how bad~     their symptoms were prior to surgery (personal communication), which may not be reflected in~     the change in QoL reported.~      This lack of awareness, while possibly helpful in everyday life, may lead to effective~     treatments looking ineffective, or the benefits in QoL of effective treatment appearing~     reduced. This confound may not only reduce the apparent effectiveness but also the related~     cost-effectiveness of treatment. As cost-effectiveness is determined by both size and~     longevity of an effect, current methods of capturing these data may be suboptimal.~   "
39974|NCT02533752|"~     Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective,~     non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the~     WATCHAN device to study the safety and effectiveness of the WATCHMAN device~   "
37801|NCT02562261|"~     Activation of blood platelets is a typical finding in patients with systemic inflammation~     and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell~     activation while their adhesion to the endothelium enhances the pro-coagulatory activity of~     endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction.~     However, the exact effects of bacterial products on platelet function have not been found to~     be consistent and may vary according to the species, the timing of the study, and the~     pathogenesis of sepsis. Data vary, including both increased and decreased platelet~     reactivity and aggregation among patients with sepsis compared to healthy controls. Defining~     platelet's behaviour during sepsis is particularly important in view of recent findings~     revealing potential association between antiplatelet therapy and reduction in short term~     mortality, incidence of acute lung injury and intensive care unit admission in critically~     ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the~     point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different~     stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and~     septic shock. Subgroup follow up of patients going along different stages will also be~     performed. At the end of this study analysis of clinical and laboratory findings in~     correlation with platelet reactivity will be performed to assess platelet aggregation during~     sepsis.~   "
37802|NCT02562248|"~     Inattentive behaviors are a common childhood condition that presents to the general~     pediatrician. While some of these behaviors are expected during childhood, others need~     work-up to ensure optimal functioning at home and school. A number of these children~     ultimately go on to have a mental health conditions, such as ADHD. However, inattentive~     symptoms represent a broad spectrum of potential behavioral and mental health conditions,~     such as pediatric anxiety which can masquerade as or co-exist with ADHD. Treatment is quite~     different and general pediatricians must have ways to facilitate the accurate identification~     of children needing further work-up and referral. Health information technology can greatly~     improve pediatricians' ability to identify and refer children with inattentive symptoms for~     further work-up. This study represents initial work to revise an existing computer decision~     support system's module for identification of ADHD to include screening questions and~     prompts for anxiety.~   "
37803|NCT02562235|"~     This study is designed to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0~     mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary~     arterial hypertension (PAH) group 1. The study consists of two phases: titration phase up to~     8 weeks and a maintenance phase up to 16 weeks.~   "
37804|NCT02562222|"~     The aim of this study is to establish an optimized protocol of tDCS that normalize the lack~     of habituation and efficiency of inhibitory cortical circuits in migraine patients and~     determine tDCS polarity and the best cortical areas to stimulate which could normalize the~     lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs~     volunteers will undergo to some tDCS protocols or sham tDCS.~   "
37805|NCT02562209|"~     This study evaluates the effects High Protein Atkin's Complete (lacto) VEgetaRian Diet~     (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian~     Indians subjects living in north India.~   "
37806|NCT02562196|"~     The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack~     of habituation and efficiency of inhibitory cortical circuits in migraine patients. For this~     purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.~   "
37807|NCT02562183|"~     In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute~     cerebral infarction ,a multi-center, open label , single group study was designed. Expect to~     enroll 60 sites and 2186 subjects. Subjects will receive a treatment of 21 days with~     kallikrein and 90 days follow-up.~   "
37808|NCT02562170|"~     Randomized controlled trial to look at early complications, cosmetic outcome, patient~     satisfaction and thickness of the tissue overlying the implant at the lower pole in~     immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with~     either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast~     cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.~   "
37809|NCT02562157|"~     Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a~     real goal for many years in the development and research of the transluminal endoscopic~     surgery (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by~     metallic stent, although minimally invasive, causes problems in long-term secondary~     obstruction and migration. Surgical treatment of these strictures is associated with~     significant morbidity and mortality . The complication rate and severity of post-operative~     surgery after gastric bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close~     to 5% with a mortality of 1%. After 3 years of experimental research on porcine model, our~     team has developed a procedure of gastro duodenal anastomosis using transgastric endoscopic~     minimally invasive surgical technique (or NOTES) - LBA UMRT24 CERC laboratory ,~     Aix-Marseille University , Faculty of Medicine North, with the aim to offer a credible~     alternative to conventional surgery.~      Thus the investigators propose to conduct a pilot prospective intervenionnal study. The~     investigators hypothetized that this technique would reduce morbidity and mortality clinical~     but also economic consequences of surgery while making it possible to obtain excellent~     results permeability and long-term functionality. This method uses a new concept of tissue~     apposition with a fully covered metallic stent to create the anastomosis under endoscopy~     exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic~     bypass will be included as part of an interventional biomedical research that will be~     conducted in one expert center. The duration of the inclusions will be 18 months. Then, the~     stent will be removed three months after insertion, at the end of the healing process, and~     each patient will be followed for one year. The primary endpoint will be the assessment of~     the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition~     stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy,~     the long term (1 year) patency of the anastomosis, the procedure duration, adverse events,~     morbidity and mortality, the quality of life and the length of stay.~      In case of failure of the NOTES procedure, the patient will be treated either by surgery or~     by conventional endoscopy according to the usual techniques without loss of chance. The risk~     / benefit ratio appears positive and a safety report will be issued after the first 4~     inclusions. There will be no supplementary examination in patient follow-up in this study~     for which a CT iconography and biology are enough. The material used in the context of this~     work is consistent with the legislation on medical devices and has received CE Mark (tissue~     apposition fully covered stent Axios ®).~   "
37810|NCT02562144|"~     The enrolled subjects will get an intravenous cannulation in both elbows. The subject will~     get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in~     one of the elbows, the other intravenous cannulation is placed in the other arm before~     placebo spray is placed, the control arm. The pain score during insertion of the~     cannulation, the incidence of adverse events and the success rate and degree of difficulty~     to place an intravenous cannulation. The subjects and the one who place the cannulations~     will be blinded to the treatment.~   "
37812|NCT02562118|"~     Background: Endocrine therapy is the standard treatment for hormone receptor positive breast~     cancer. However, both primary and acquired resistance occurs, and better strategies to~     improve treatment outcome and overcome resistance are urgently needed. There is known cross~     talk between RET and ER, and preclinical studies have suggested that combining a RET~     inhibitor with endocrine therapy may improve cell kill in breast cancer cell lines.~      Aim: To determine the safe dose of lenvatinib that can be co-administered with letrozole in~     a phase Ib study, followed by a phase II study to determine the efficacy of lenvatinib +~     letrozole in post-menopausal patients newly diagnosed with hormone receptor positive breast~     cancer in the neoadjuvant setting.~      Methods: Eligible patients will be treated with 2 weeks of single agent lenvatinib, followed~     by 12 weeks of lenvatinib + letrozole. Blood and tumor samples will be obtained from the~     patient serially to study tumor and host factors that may influence drug efficacy and~     toxicity.~      Importance of the proposed research: The combination of lenvatinib + letrozole may improve~     the treatment response in some ER+ breast cancers. The study will seek to identify~     biomarkers (eg tumor RET expression) that may select patients most likely to benefit from~     the combination therapy.~      Potential benefits and risks: The combination may improve treatment response. Adding~     lenvatinib may increase treatment risks, but these will be monitored closely.~     Pharmacokinetic analyses will also be performed to determine the drug levels achieved in the~     patients, and correlate that with treatment toxicity and efficacy.~   "
37813|NCT02562105|"~     This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients~     admitted to the intensive care unit of Mansoura oncology center through a cohort study as~     regards their need for mechanical ventilation during two years.~   "
37814|NCT02562092|"~     This study aims to understand the barriers to receiving HIV testing and retention of care~     for at risk and HIV positive young adults. This study also seeks to determine the~     feasibility and acceptability of HIV testing in a non-clinical setting.~   "
37815|NCT02562079|"~     It is a study of basic research with mechanistically objectives and including clinical~     biological samples.~   "
37816|NCT02562066|"~     This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover~     study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients~     (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open~     label (amifampridine phosphate) or history of sustained amifampridine benefit from~     treatment.~   "
37817|NCT02562053|"~     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using~     computer generated random numbers. Group 1 will receiveCombined oral contraceptives (COC)~     containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg) daily for 21 days~     starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group~     2 will receive fluoxetine 20 mg daily in addition to an oral placebo similar to COC daily~     for 21 days starting from the 3rd day of menstruation.Group 3 will receive oral placebo~     similar to COC daily for 21 days starting from the 3rd day of menstruation in addition to a~     daily oral placebo similar in size, color and structure to fluoxetine.~   "
37818|NCT02562040|"~     The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on~     the behavior, sleep-disordered breathing symptoms and quality of life for children who~     snore, but do not have obstructive sleep apnea, as well as identify factors that moderate~     responses to the surgery. Half of participants will receive eAT, while the other half will~     be observed with watchful waiting and supportive care.~   "
37819|NCT02562027|"~     A principle objective of the study is to create a validated risk model for treatment~     selection. This will greatly enhance the ability to counsel patients regarding their~     specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making~     on the part of the patient, and remove much of the subjectivity of treatment selection.~   "
37820|NCT02562014|"~     The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the~     promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role~     in preventing diabetes. The investigators aimed to compare the effects of two fermentable~     fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty~     acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and~     obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover~     design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions.~     On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose~     plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after~     the test drink.~   "
37821|NCT02562001|"~     The spinal cord injury is identified as the major cause of permanent disability worldwide,~     with the loss of ability to walk being the largest and most devastating of them for these~     patients. In this way, our goal is to analyze the effects of treatment with electrical~     transcranial direct-current stimulation of high definition (HD-tDCS) associated with gait~     training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the~     march of patients with incomplete spinal cord injury (SCI). This randomized double-blind~     study will be built on the existing work already conducted at the Physical Medicine and~     Rehabilitation Institute of Medical School of the University of Sao Paulo, General Hospital.~     Outpatients (GA) and inpatients (GI) with spinal cord injury (AIS C and D) will receive~     active or placebo HD-tDCS followed by gait training with Lokomat (GA: 3 sessions / week X 6~     weeks = 18 sessions; GI: 5 sessions / week x 6 weeks = 30 sessions). The functional~     assessments (through clinical and functional scales, assess gait, muscle strength,~     spasticity, balance and pain) and neurophysiological (cortical excitability measured by~     transcranial magnetic stimulation) will be held before and immediately after the training~     period and after a 3 months follow up. The expected result is that patients that received~     the active HD-tDCS presents an improvement over the ground gait after the Lokomat training~     period significantly greater than the placebo group, with positive correlations between~     neurophysiologic, kinematics and functional measurements.~   "
37822|NCT02561988|"~     This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of~     BLU-285, administered orally (PO), in adult patients with advanced systemic mastocytosis and~     other relapsed or refractory myeloid malignancies. The study consists of 2 parts, a~     dose-escalation part (Part 1) and an expansion part (Part 2).~   "
37823|NCT02561975|"~     An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.~      There is a correlation between injury of pulmonary diffusing, chronic heart failure~     intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance~     test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.~      The nature of damage (vascular or membrane) can be determined by the measure of double~     pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).~      Today, in chronic heart failure consecutive to a congenital heart disease, there is no data~     on evolution of membrane and capillar factors.It is impossible to predict if membrane damage~     will be the best factor correlated to the VO2max in patients suffering from complex~     congenital heart disease.~      Assessing these parameters could be an comparative evaluation of heart-rate exercise~     tolerance test with VO2max and an early control of his damage without risks related to~     heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart~     disease.These results would have an early prognostic value that would permit to refine the~     follow-up and the treatment.~      The main objective of this trial is to assess the statistic correlation between the membrane~     injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in~     children and adults suffering from complex congenital heart disease.~   "
37824|NCT02561962|"~     This is a first in human phase 1 multicenter open label study in subjects with relapsed or~     refractory multiple myeloma.~   "
37825|NCT02561949|"~     The research will first examine data obtained from YRI participants to investigate effects~     of the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The~     research also intends to examine whether youth participating in YRI and complementary income~     generating activities will fare better than an employment only control group. Finally, the~     research intends to examine whether utilizing lay health workers are a is cost-effective and~     scalable method for addressing mental health concerns.~      The research will investigate the following hypotheses:~        1. Participants who are exposed to YRI will demonstrate greater reduction in mental health~          and behavioral problems than participants who are waitlisted for YRI over the same~          period; emotion regulation will operate as a major mechanism of YRI improvements; high~          comorbidity will be a treatment modifier;~        2. Improvements in mental health and functioning due to YRI will lead to (mediate) greater~          employment outcomes and superior economic self-sufficiency over time; and~        3. Homelessness, orphanhood, young parenthood, and high problems in emotion regulation~          co-morbid with other mental health conditions will be major moderators lessening the~          effectiveness of YRI.~        4. Lay and trained practitioners at agencies participating in the combined mental~          health-employment program will demonstrate high fidelity to evidence-based treatment~          components and that good satisfaction, social support, and professional exchange of~          evidence-based practices will emerge.~   "
37826|NCT02561936|"~     The purpose of this study is to compare the rate and extent of absorption of rilpivirine in~     healthy adult participants following: 1) administration of a single dose of two different~     oral dispersible tablet formulation candidates and of an oral granules formulation with that~     following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT),~     after a standardized breakfast; 2) administration of a single dose of one selected oral~     formulation candidate (a dispersible tablet or granules) in different fed conditions~     (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3)~     administration of a single dose of one selected oral formulation candidate (a dispersible~     tablet or granules) dispersed in water or in orange juice, in fed condition (standardized~     breakfast).~   "
37827|NCT02561923|"~     The purpose of this study is to assess the independent effects of both a 4-Factor~     prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding~     parameters (bleeding duration and blood volume) following a punch biopsy, in addition to~     assessing their effects on the anticoagulant/pharmacodynamic (prothrombin time and~     endogenous thrombin potential) changes induced by rivaroxaban at steady state, to better~     understand their potential role in bleeding reversal.~   "
37828|NCT02561910|"~     The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one~     year period a total of 1208 inguinal hernias in 952 patients were consecutively operated~     using the laparoscopic technique by a total of 11 general surgeons in daily clinical~     routine.~      Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the~     standard procedure in inguinal hernia repair in future.~   "
37829|NCT02561897|"~     This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety~     and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF)~     undergoing clinically indicated implantation or replacement of cardiovascular implantable~     electrical devices.The primary objective is to compare the rates of local and systemic~     bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous~     warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular~     AF.~   "
37830|NCT02561884|"~     To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs~     Olmetec and Crestor.~   "
37831|NCT02561871|"~     The purpose of this study is to assess the safety and tolerability of intramuscular~     prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2~     (human adenovirus-vectored vaccine candidate) in healthy participants.~   "
37844|NCT02561702|"~     Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70~     causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to~     85% of patients with some subtypes of CMT. These cramps impact quality of life and have been~     identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA~     approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for~     treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of~     effective therapy for muscle cramps.~   "
37920|NCT02560701|"~     Using eleven years (2004-2014) of claims data from the largest US commercial health insurer,~     the investigators will assess the impact of switching into high-deductible health plans~     (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include~     patients with and without high medication cost-sharing and vulnerable populations~     (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and~     caregivers recruited through a major advocacy group will provide further insights into the~     policy issues with real-life experiences.~   "
37832|NCT02561858|"~     Patients who are overweight or obese, diabetic or not, share with those who are suffering~     from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney~     ammoniogenesis default. This results in an overly acidic urine pH which is directly~     pathogenic in people predisposed to develop uric stones because the precipitation of urate~     soluble uric acid is accelerated in acid medium.~      Excess visceral fat, particularly perirenal, this defect may promote formation of renal~     ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a~     common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal~     fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the~     pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential~     hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are~     positively correlated.~      Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric~     because of anatomical links between kidney stones and greasy environment and because excess~     fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic~     syndrome.~      For the test, the investigators will compare the amount of fat and perirenal renal ability~     to form ammonium in patients with uric or calcium lithiasis taking into account the amount~     of intra-abdominal fat.~   "
37833|NCT02561845|"~     Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an~     increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI)~     patients and the population is well suited to demonstrating rosuvastatin's low density~     lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV~     risk, and as such here is an increased need for intensive lipid management in PCI patients~     and the population is well suited to demonstrating rosuvastatin's LDL-C lowering~     efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level~     reduction (LDL-C, high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and~     non-HDL-C) and lipid goal attainment according to recent guidelines.~   "
37834|NCT02561832|"~     This is an open-label study to assess the safety, tolerability and efficacy of olaparib in~     combination with carboplatin. There are two parts in this study: Part A, a dose escalation~     in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and~     Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer~     patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.~   "
37835|NCT02561819|"~     This study will determine if air-displacement plethysmography (ADP) provides accurate~     measurement of body composition (percent body fat and fat-free mass) in pediatric patients~     with intestinal failure, as compared to body composition measured by alternative standard~     methods, including deuterium dilution, bioimpedance analysis (BIA), dual x-ray~     absorptiometry (DXA) when clinically indicated, and routine anthropometric measurements.~   "
37836|NCT02561806|"~     The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab~     compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.~   "
37837|NCT02561793|"~     440 women with expected poor ovarian response undergoing IVF/ICSI (intracytoplasmic sperm~     injection) will be randomly divided into 2 groups using computer generated random numbers .~     Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol~     , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle. Group 2 ( control group)~     will receive a placebo. Patients included in the study will be subjected to full history~     taking and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin~     and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using~     a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On~     the day of HCG administration, ovarian ultrasound scan will be performed using a~     transvaginal probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes~     will be fertilized and embryos will be transferred. Both groups will be compared regarding~     the proportion of pregnancy.~   "
37838|NCT02561780|"~     This study examines the effectiveness of a school based mental health literacy intervention~     for high school students, on improving mental health knowledge and reducing stigma.~     Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to~     either the curriculum or control condition at a two to one ratio. The educational curriculum~     was integrated within grade 11 and 12 Provincial Healthy Living courses, delivered by~     teachers, and replaced existing educational content on mental health.~   "
37839|NCT02561767|"~     This study is designed to determine the efficacy and safety of allogeneic bone~     marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after~     citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are~     randomized into two groups: MSCs group and control group. Besides routine induction therapy~     (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA +~     prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic~     bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal~     reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function,~     rejection, patient/graft survival and severe adverse events within 12 months post-transplant~     are monitored.~   "
37840|NCT02561754|"~     The goal of this study is to explore the impact of two different diets (conventional vs.~     enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight~     across 18 months in overweight and obese adolescents with intellectual and developmental~     disabilities.~   "
37841|NCT02561741|"~     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study~     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on~     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.~   "
37842|NCT02561728|"~     The purpose of this study is to examine a group of patients requiring helmet therapy (either~     patients with plagiocephaly or post-surgical patients) to compare outcomes of infants~     treated with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod~     Helmet (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The~     investigators' goal is to determine which helmet is more effective in skull remodeling and~     to standardize the investigators' care for these patient types.~   "
37845|NCT02561689|"~     Background: Occlusal caries is the main reason for restorative therapy in the young~     permanent dentition, but restorations have limited survival time and may also weaken the~     tooth. An intact fissure sealing is an effective preventive treatment of occlusal caries~     lesions and may be used therapeutically to arrest the caries progression. However, the major~     challenge with fissure sealants is the frequent need for re-treatments, mostly due to~     inadequate retention.~      Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used~     prophylactically and therapeutically in permanent molar teeth.~      Study design: The study is carried out as a prospective, clinically controlled study with~     split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities~     in Denmark uses 2 of the 6 sealants. The treatments are examined clinically and~     radiologically after 1, 2, 3, and 5 years.~   "
37846|NCT02561676|"~     Chronic pain (pain that is that is present for a long period of time) is very common among~     people with spinal cord injury (SCI).~      The purpose of this study is to compare how well two different web-based education programs~     reduce the level to which chronic pain interferes with daily activities and well-being.~   "
37847|NCT02561663|"~     Rationale: Subjects with the metabolic syndrome have an increased risk of developing~     cardiovascular disease and a twofold risk of developing hypertension. A functional food~     ingredient with the ability to improve arterial stiffness, microcirculation and/or the~     ability to reduce blood pressure could potentially contribute to the delay or prevention of~     a range of cardiovascular diseases and could provide additional complimentary alternatives~     to pharmacological and lifestyle based interventions in the maintenance of cardiovascular~     health.~      Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily~     administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave~     Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV,~     characteristics of microcirculation, systolic and diastolic blood pressure, lipid and~     lipoprotein metabolism, glucose metabolism and incretins.~      Study design: Investigators propose to carry out a randomized, double-blind, placebo~     controlled crossover study.~      Study population: Eligible subjects will be male or female, non-smokers between 18-75 years~     of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic~     Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be~     randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the~     end of the study.~      Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once~     daily, on separate occasions, for a period of 4 weeks and with a washout period between the~     two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or~     extended by 8 weeks, depending on the availability of the subject. Total study duration will~     be 10 - 16 weeks, depending on the duration of the washout period.~      Main study parameters/endpoints: Measurements will be performed at the start and end of each~     4-week intervention period. Effects of NWT-03 supplementation will be calculated as the~     absolute differences between values obtained at each period. The main study endpoint is the~     change in cr-PWV.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Before the study starts, subjects will be screened to determine eligibility~     during a screening visit. During this visit, body weight, height, waist circumference and~     blood pressure will be measured and a venous blood sample (10 mL) will be collected. During~     the study, subjects will receive NWT-03 and placebo powders in random order and are asked to~     consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of~     the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph~     and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the~     designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and~     another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be~     collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in~     females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a~     food frequency questionnaire and to provide a spot urine sample at visits 4 and 7.~     Furthermore, subjects will be asked to keep a study diary throughout the duration of the~     study. Total time investment for the subjects will be approximately 19 hours. Apart from~     bruises or hematoma, rarely induced by blood sampling, no risks are associated with~     participation in this study.~   "
37848|NCT02561650|"~     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study~     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on~     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.~   "
37849|NCT02561637|"~     Patients in fast-track programmes are required to take an active part in their treatment and~     rehabilitation. Spouses of older patients can often provide valued practical and emotional~     support, reducing stress, pain and length of stay - yet they are seldom invited to~     participate in a supporting role. The aim of this study is to investigate the effect of~     spouses' involvement in older patients fast-track treatment programs using case management~     as intervention. A two-group quasi-experimental design with pre-test and repeated post-test~     measures (protocol approved in November 2012) was used. Patients aged 65 years or older~     going through a fast-track programme for a total hip replacement and their spouses was~     recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and~     for the control group (n=14). Data was collected from both groups at baseline, two weeks and~     three months after surgery. Outcome measures for patients include: functional status,~     nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver~     satisfaction and difficulties and anxiety.~   "
37850|NCT02561624|"~     The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria~     prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net~     distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to~     electronic vouchers in this program has increased efficiency and the ability to track and~     distribute nets since 2007. Although the program has been successful, to date, electronic~     voucher redemption varies widely across the country and it has not been clearly established~     as to what barriers exist for women who receive electronic vouchers in the program. This~     cluster-randomized trial was designed to examine perceived barriers to electronic voucher~     redemption among pregnant women and to evaluate if educational and personalized text~     messages around electronic voucher redemption and bed net usage will increase electronic~     voucher redemption when directed at pregnant women who receive electronic vouchers in the~     currently existing program.~   "
37851|NCT02561611|"~     The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative~     multi-component intervention focused on increasing energy expenditure and re-balancing the~     disrupted energy balance equation of sedentary workplaces with an ultimate target of~     reducing workers' abdominal obesity.~   "
37852|NCT02561598|"~     The purpose of the study is to develop methods to identify predictors of Malignant~     Hyperthermia.~   "
37853|NCT02561585|"~     This clinical trial attempts to investigate the efficacy and safety of LEO 124249 in the~     treatment of alopecia areata and the molecular disease mechanism and biomarkers.~   "
37854|NCT02561572|"~     Preoperative anxiety has been associated with adverse consequences, including increased~     anaesthetic and analgesic requirements and overall dissatisfaction with care. Traditionally~     this has been treated with sedative drugs, such as benzodiazepines, but these can be~     associated with a sedative hangover with sedation continuing into the postoperative~     period. This is undesirable in patients undergoing neurosurgical procedures, as there is a~     need to assess neurological status in the immediate postoperative period. Acupuncture at the~     Yintang point (on the forehead between the eyebrows) has been shown to effectively reduce~     preoperative anxiety, but studies undertaken in the United Kingdom and neurosurgical~     population are lacking. The investigators aim to investigate the effect of acupuncture at~     the Yintang point on preoperative anxiety. Anxiety levels will be measured using two~     validated questionnaires: the State-Trait Anxiety Inventory (STAI) and Amsterdam~     Preoperative Anxiety and Information Scale (APAIS).~   "
37855|NCT02561559|"~     In this study the investigators treat PM oligometastatic patients with SBRT. Our objective~     is to evaluate rate of local control of treated lesions in patients treated with Intensity~     Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung~     metastases from STS.~   "
37856|NCT02561546|"~     An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in~     treatment of diabetes concurrent with hepatocellular carcinoma (HCC).~   "
37857|NCT02561533|"~     Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle~     aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the~     mutation specific antibody VE1.~   "
37858|NCT02561520|"~     The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich~     Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of~     ocular graft versus host disease (O-GVHD). In addition to their current medication (except~     autologous serum drops), patients will receive PRP and PPP drops.~   "
37859|NCT02561507|"~     This is a survey of members of the American College of Surgeons (ACS), to describe and~     explore current patterns of their decisions about withholding or continuation for patients~     taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore~     surgeons' knowledge about the risks and benefits attending this decision, and about national~     organizations' recommendations.~   "
37861|NCT02561481|"~     ASD is a diverse disorder starting in early childhood and characterized by social~     communication impairment as well as restricted interests and repetitive behaviors. It~     affects 1:68 children and is an enormous medical and economic problem for which there is no~     established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from~     broccoli, and has potent activity in transcriptionally up-regulating genes that control~     mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial~     dysfunction, and inflammation.~      This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and~     girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive~     active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive~     sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks.~     Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism~     Clinical Clinical Impressions Scale - Severity and Improvement (OACIS-S and OACIS-I),~     Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded.~     Children will be monitored with physical examinations and for toxicity with clinical~     laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2~     (Nrf2), oxidative stress and mitochondrial function, the mechanistic target of rapamycin~     (mTOR) pathway and cytokine expression. In addition, prior to the main clinical trial, a~     pilot study will be carried out in 10 children with ASD, 6-12 years of age, who will receive~     sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the~     end of treatment will be collected, in order to measure several parameters that are likely~     to demonstrate expected effects of sulforaphane, to standardize the assays and procedures,~     and to determine the most effective measures.~   "
37862|NCT02561468|"~     Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast~     cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be~     reduced.~   "
37863|NCT02561455|"~     The purpose of the study is to provide access to continued treatment for subjects who~     participated in other Astellas sponsored ASP2215 trials and for whom the Investigator feels~     the subject may benefit from continued treatment.~   "
37864|NCT02561442|"~     The proposed study aims to assess the time above MIC (4 mg/mL), and the~     pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by~     constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone~     administered as a constant IV infusion over 0.5 hours. In addition, the study will compare~     the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2~     g ceftriaxone administered subcutaneously~   "
37865|NCT02561429|"~     Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy~     and safety of SPT were proved. The positive control of SPT is histamine.~      In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in~     some practice they use other concentration (1, 2.5 mg/ml).~      This study will find the proper concentration of histamine for positive control use in SPT.~   "
37866|NCT02561416|"~     Purpose:~      Fibromyalgia syndrome (FMS) is a disabling condition mainly characterized by chronic~     widespread pain, disturbed sleep, fatigue, and distress. The estimated overall prevalence of~     FMS in Europe is 2.9% and it incurs in high personal, social and healthcare costs. Available~     treatments in FMS are not curative and there is some evidence of positive effects of~     mindfulness-based stress reduction (MBSR) in patients with chronic pain and FMS.~     Nevertheless, although promising, the positive findings obtained in previous studies~     implementing mindfulness-based interventions in patients with FMS have to be interpreted~     with caution due to important methodological limitations (e.g. absence of randomization,~     high attrition rates, or small sample sizes). Therefore, further research in larger studies~     using more adequate methodologies is warranted. Furthermore, little is known about putative~     neurobiological processes underpinning the effects of mindfulness training in patients with~     chronic pain.~      Aims: The aim of this randomized, controlled trial (RCT) is two-fold: firstly, to assess the~     effectiveness and cost-utility of MBSR added to treatment as usual (TAU); and secondly, to~     evaluate the effects of the compared interventions on neurobiological parameters.~     Specifically, MBSR will be compared to an active control which was previously reported as a~     cost-effective intervention (TAU + FibroQol psycho-educational program; Luciano et al.,~     2013) and also vs. TAU alone (in a 12-month follow-up RCT). Brain structure and function of~     pain-relevant areas and levels of inflammation markers (cytokines) will be assessed pre-post~     interventions in half of the study participants.~      Methods:~      Design: RCT with three arms:~        1. TAU + MBSR,~        2. TAU + FibroQoL and~        3. TAU.~      Sample: 180 adults with FMS according to the ACR 1990 criteria (N=60 for each study arm)~     will be recruited from from the Parc Sanitari Sant Joan de Déu Rheumatology Service, Sant~     Boi de Llobregat, Spain. Half of the participants will be randomly selected to participate~     in the neurobiological pre-post evaluation (N= 30 each group). All patients will be assessed~     at baseline, post-intervention and 12-month follow-up for clinical variables, prep-post~     intervention for biomarkers study, and baseline and 12-month follow-up for cost-related~     variables.~   "
37867|NCT02561403|"~     The purpose of this study is to conduct a pilot trial investigating cognitive training in~     older Veterans with a history of traumatic brain injury (TBI) to assess training effects,~     acceptability of training to participants, and to explore whether other factors influence~     training effects.~   "
37868|NCT02561390|"~     The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC~     found that prevalence of AR and asthma inThailand was in moderately high group.~      Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of~     allergen in patient. They guided the investigators for proper management as well as patient~     education. Clinician will use the result for choose allergen in case that might need~     immunotherapy.~      SPT is safe and more economic for patient. Specific IgE has an advantage in patient who~     cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT~     and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between~     two tests. In Thailand, the investigators haven't had data about it yet.~   "
37869|NCT02561377|"~     This study evaluates the efficacy of a 12-month resistance training on metabolic control and~     reducing the risk of diabetes.~   "
37870|NCT02561364|"~     The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in~     pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile~     (BPP) is a score that is intended to assess fetal well-being. This test will be performed~     within the expected time of the routine ultrasound exam.~   "
37871|NCT02561351|"~     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide~     (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma~     exacerbation according to the global initiative for asthma guideline.~   "
37872|NCT02561338|"~     This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type~     2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will~     receive placebo.~   "
37921|NCT02560688|"~     This study is being conducted to test the hypothesis that coadministration of clopidogrel~     with DS-1040b will be safe and well tolerated. Subjects entering the study will initially~     receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b~     alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects~     will receive repeated clopidogrel doses over 5 days to generate data on the effect of~     clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and~     the effects will be compared to when the two treatments were given alone.~   "
37873|NCT02561325|"~     Many large-scale epidemiological studies have established a link between the average~     consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted~     in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health~     authorities considered it appropriate to reduce consumption about 20%, by limiting~     contributions of sodium in prepared foods, bread.~      In terms of basic and clinical research, the biological effects of sodium chloride dietary~     intake, have been the subject of numerous studies for several decades. This work showed that~     all subjects do not react uniformly to sodium chloride flows, determining what the~     investigators call people sodium-sensitive. For these people the sodium intake elevated~     blood pressure, much more marked than in subjects called sodium-resistant.~      Sodium-sensitive people represent 10 to 30% of the population. A marked~     over-representation of this phenotype was observed in patients with hypertension or a family~     history of hypertension.~      In addition, studies conducted in animals and humans indicate that sodium intake has a~     different impact on biological parameters mentioned above, as is done in the form of~     chloride salt or bicarbonate of sodium.~      Based on these factors, investigators developed a clinical trial protocol intended to~     highlight a possible differential effect in the biological effects of the same sodium intake~     (2.56 g / day) orally, depending on the nature salt.~   "
37874|NCT02561312|"~     Chronic blood transfusions are essential supportive care for sickle cell patients at high~     risk for morbidity and mortality due to stroke. These patients, however, are at risk for~     iron overload. In the investigator's comprehensive sickle cell center, the investigators~     support chronic transfusion with rapid manual partial exchange transfusions (RMPET) using a~     single access central line port. The investigators do not have a comprehensive adult sickle~     cell program but upon transition of patients the patients would be provided simple~     transfusion (ST) in an adult ambulatory infusion setting due to nursing acuity needed for~     RMPET. The investigators plan to study the institution's participants currently on chronic~     transfusion support and compare different transfusion modalities to better understand the~     effects from switching from RMPET to ST. To date, there are no such comparisons within and~     between sickle cell patients in the literature.~   "
37875|NCT02561299|"~     The purpose of this study is to prospectively evaluate acute and long term clinical results~     of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB~     angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK)~     lesions.~   "
37876|NCT02561286|"~     The incidence of HIV/AIDS among African American men who have sex with men (MSM) is~     alarming, and the public health response to this urgent situation has been hampered by a~     lack of sexual risk reduction interventions with solid evidence of efficacy in this~     population. Accordingly, the broad, long-term objective of the proposed research is to~     identify interventions to reduce the risk of sexually transmitted infection (STI) among~     African American MSM. This application seeks funds to develop and test the efficacy of a~     theory-based, contextually appropriate behavioral intervention to reduce sexual risk~     behavior among African American MSM. Intervention development will be guided by social~     cognitive theory, the theory of planned behavior, qualitative information from focus groups,~     and findings from a longitudinal survey of men from the study population. A one-on-one~     intervention will be utilized to address the specific prevention needs of each man and to~     allay participants' concerns about revealing their sexual involvement with men by virtue of~     participating in a group or workshop intervention. The study will utilize a randomized~     controlled trial design, with baseline, immediate post intervention, and 6 and 12 months~     post intervention assessments. The participants will be African American MSM who will be~     randomized to a one-on-one sexual risk reduction intervention or a one-on-one health~     promotion intervention that will serve as the control condition. The primary outcome is~     consistent condom use during anal and vaginal intercourse. The study will test whether the~     intervention increases the consistent use of condoms during anal intercourse, the primary~     outcome, whether it decreases other sexual risk behaviors, and whether social cognitive~     theory variables mediate the effects of the intervention on consistent condom use. This~     study will provide an urgently needed intervention to reduce the risk of HIV and other STIs~     in one of the highest risk populations in the United States.~   "
37877|NCT02561273|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with combination chemotherapy and to see how well they work in treating patients~     with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     etoposide, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may~     stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new~     blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide~     may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.~   "
37878|NCT02561260|"~     In recent years, more and more previously thought to be unknown encephalitis was found to be~     a specific antigen associated encephalitis，but because of the lack of recognition in the~     clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent~     to establish a database of autoimmune encephalitis in Chinese population. The prospective~     clinical trial of atutoimmune encephalitis in China, by screening the autoimmune~     encephalitis associated antibody and summarizing the cases analysis, in order to provide~     evidence for clinical diagnosis and treatment of autoimmune encephalitis.~   "
37879|NCT02561247|"~     The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex®~     HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement~     therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing~     blood urea nitrogen (BUN).~   "
37880|NCT02561234|"~     This is the first-in-human study of the safety of increasing dose levels of AEB1102 in~     patients with advanced cancers. The study will also evaluate the amounts of AEB1102 in~     blood, the effects of AEB1102 on blood amino acid levels and tumor growth.~   "
37881|NCT02561221|"~     The primary aim of this trial is to develop and test the effectiveness of a 24 month,~     patient-centered, pragmatic and scalable obesity treatment program delivered within primary~     care, inclusive of an underserved population. Half of the participants will receive a~     behavioral intervention delivered in a primary care setting and half of the participants~     will receive usual care.~   "
37906|NCT02560883|"~     The overall objective is to develop a clinical data registry that can be used to facilitate~     research with the ultimate goal of reducing the morbidity and/or mortality and improving the~     quality of life of patients diagnosed or living with hairy cell leukemia. With approximately~     600 new cases of this rare disease identified in the US each year, HCL represents 2% of all~     cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell~     Leukemia Foundation (HCLF), in partnership with investigators from its Centers of~     Excellence, seeks to develop a registry to help researchers identify new trends in outcomes,~     recognize the most effective treatments, discover previously unknown complications of the~     disease, and design clinical trials for new therapies.~   "
37882|NCT02561208|"~     Cervical cancer remains a serious health problem, particularly in developing countries. It~     is the leading cause of cancer death among women and mainly affects women of low~     socioeconomic status.~      Evidence has shown that HPV-test self-collection can reduce social and health services~     barriers to screening and increase coverage. However, high coverage will not result in a~     decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates~     whether a woman is positive or not, and a triage test is needed to identify HPV-positive~     women who need to perform diagnostic procedures. Several triage methods are available. In~     Argentina, cytology is used as triage method; therefore, all HPV-positive women who have~     performed self—collection at home need to attend health centers to undergo cytology.~     However, the proportion of women who have completed triage is low, therefore new innovative~     strategies are needed to increase attendance to cytology of these women.~      This study will be carried out in Jujuy, one of the Argentinian provinces with highest~     cervical cancer mortality rates and where HPV- self-collection has been introduced as~     programmatic strategy for screening under-users.~      This trial is population-based cluster-randomized study that aims to evaluate the~     effectiveness of a mHealth intervention versus usual care to increase adherence to~     cytological triage among women with HPV-positive self-collected tests.~      An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System~     (PHCS) of the Province of Jujuy will be randomized into two groups:~        1. mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed~          intervention which includes counseling through an interactive Apps specifically devised~          to increase adherence to triage which will be run on a tablet, and SMS text messages to~          remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services~          and CHWs will receive reminders via e-mails and SMS message to contact women if after~          60 days from the HPV-results HPV+ they have not performed triage.~        2. Usual Care Group: Women with HPV self-collected tests receive usual care.~      A database built specifically for the study will be used; it will include data about~     randomization Group, agreement to participate in the study and socio-demographic data. Data~     on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique~     Identification Number (DNI).~      Data Analysis~      Effectiveness to enhance adherence to cytological triage: Adherence to triage will be~     considered for each CHW. This will be defined as the number of women with triage smears~     within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive~     women that did the Pap test within those time intervals in the mHealth intervention group~     and the Usual Care group. The effect of the mHealth intervention against usual care will be~     estimated using a means difference test or a non-parametric test for independent samples.~   "
37883|NCT02561195|"~     This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85~     years. Each subject will receive 3 doses of vaccine on 1 of 2 vaccination schedules. The~     study will assess the safety and tolerability of the vaccine as well as the subjects' immune~     response to the vaccine.~   "
37884|NCT02561182|"~     The goal of this study is to determine whether or not patients with overgrowth syndromes~     have decreased bone density.~   "
37885|NCT02561169|"~     A multi-centre, randomized, placebo controlled, trial. Participants will be patients either~     ≥65 years or with one or more high risk conditions presenting to one of four academic~     emergency departments in Edmonton or Calgary with influenza-like illness. The investigators~     will test for influenza using a point-of-care rapid test and if positive for influenza~     participants will be randomized to oseltamivir or placebo and followed prospectively. The~     primary outcome will be hospitalization.~   "
37886|NCT02561156|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     TAK-653 when administered as single and multiple oral doses at escalating dose levels in~     healthy participants.~   "
37887|NCT02561143|"~     Investigators are evaluating the nutritional role of IAtta supplementation along with~     nutritional counselling in delaying the progression of cachexia to refractory cachexia in~     adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100~     g) for daily consumption for 6 months. Dietary and physical activity counseling will be~     imparted every fortnight to patients.~      Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at~     baseline, after 3 months and at 6 months of intervention for all patients.~      Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary~     and physical activity counselling) for six months will improve the health status and quality~     of life in free-living patients suffering from cancer cachexia.~   "
37888|NCT02561130|"~     The purpose of the study is to determine whether in patients with early type 2 diabetes, a~     short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin~     glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving~     sustained diabetes remission.~   "
37889|NCT02561117|"~     The objective of this study is to determine whether administering once-daily doses of~     metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated~     appendicitis, is as effective in children as delivering it in the standard method of once~     every eight hours. Reducing the frequency of administration has the potential of decreasing~     personnel time and healthcare cost and increasing the lifespan of the IV line.~      To determine the effectiveness once-daily administration, a randomized controlled trial~     (RCT) will be conducted to compare outcomes between the two treatment schedules. We will~     recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated~     appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to~     one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such~     as duration of hospital stay and theoretical cost will be measured and analyzed using~     statistical tests.~   "
37890|NCT02561104|"~     The study design will be a prospective study comparing laser-assisted cataract extraction~     cases and traditional manual phacoemulsification cases. All cases will be performed by~     faculty-supervised residents at Parkland Memorial Hospital. This study aims to examine~     visual acuity and complication rates in femtosecond laser-assisted cataract surgery compared~     to traditional manual phacoemulsification cataract surgery for the beginning surgeon. In~     addition, this study will assess the subjective novice surgeon experience and the patient~     experience in terms of expectations and results.~   "
37891|NCT02561091|"~     The purpose of this research study is to test the effectiveness and safety of the study~     drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where~     the cause is unknown.~   "
37892|NCT02561078|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous~     insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2~     diabetes mellitus.~   "
37893|NCT02561065|"~     The main objective of TANSNIP-PESA is to determine in a population of asymptomatic bank~     employees with high and low imaging defined cardiovascular disease (CVD) risk the~     effectiveness of a comprehensive 3-year worksite-based lifestyle intervention consisting of~     12 personalized lifestyle counseling sessions, a Fitbit physical activity tracker and a~     sit-stand Workstation.~   "
37894|NCT02561052|"~     Masimo Corporation has developed a new parameter for noninvasive monitoring by optical~     sensors, Oxygen Reserve index (ORI). ORI is believed to correlate with the partial pressure~     of arterial blood oxygen (PaO2).~      Aim of this study is to validate the oxygen reserve index in healthy volunteers undergoing~     controlled hyperoxia and hypoxia.~   "
37896|NCT02561026|"~     Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results~     prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or~     incision). The most frequent group that requires FP transfusions are patients admitted to an~     intensive care unit. These patients frequently have abnormal coagulation tests and also~     frequently require invasive medical procedures that can be associated with bleeding. While~     FP transfusions can improve abnormal coagulation test results, there is no evidence to~     suggest that prophylactic FP transfusions will reduce bleeding associated with medical~     procedures in patients with mild coagulation abnormalities. Additionally, it is known that~     important adverse complications occur with FP transfusions.~      The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU~     patients who require an invasive medical procedure (central venous catheterization, chest~     tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals.~     Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP~     transfusion or no treatment prior to an invasive procedure.~      The primary outcome for this pilot study will be feasibility (the number of patients~     enrolled per month). Other important outcomes will include those that will be evaluated in~     the definitive trial including bleeding post procedure, red cell transfusions, adverse~     transfusion reactions, mortality and hospital length of stay.~      The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.~   "
37897|NCT02561013|"~     The purpose of this study is to evaluate the product performance of a new adjustable~     compression system for the treatment of venous leg ulcers.~   "
37898|NCT02561000|"~     The object of the study is to determine whether different doses of PZ-128, when added to~     standard medical care in persons undergoing cardiac catheterization/percutaneous coronary~     intervention, will increase the risk of bleeding.~      A secondary objective is to determine whether patients treated with PZ-128 have fewer~     cardiac events such as heart attack, bypass surgery or stroke compared with those persons~     treated with the standard of care.~   "
37899|NCT02560974|"~     This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation~     alone in chemotherapy-naive participants who have undergone potentially curative resection~     for gastric cancer. Participants will be randomized to either the chemotherapy arm or the~     observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared~     (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin~     will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles.~     The anticipated time on study treatment in 6 months and the target sample size is 1024~     individuals.~   "
37900|NCT02560961|"~     Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific~     muscles, the thickness of which is similar to that of the epidermis. This tape can be~     stretched to 140% of its original length, which demonstrates greater elasticity in~     comparison to conventional bandages. According to the creator of this method, Kinesio taping~     leads to better muscle activation or inhibition, reduces pain, swelling and muscle spasms~     and prevents muscle injury. Objective: The aim of the proposed study is to compare and~     analyze the immediate effect of Kinesio taping and placebo taping on performance during~     unilateral vertical jump and two hop tests by young professional soccer players. Methods: A~     randomized, placebo-controlled, double-blind, clinical trial will be conducted involving 100~     athletes. The volunteers will be submitted to an evaluation of the dominant lower limb using~     the Single Leg Hop Test and Single Leg Triple Hop Test as well as the evaluation of a~     unilateral vertical jump on a pressure platform. The athletes will then be randomly~     allocated to two groups. Group A will receive Kinesio taping of the triceps surae muscle as~     described by Kase (2003, 2013) and Group B will receive a placebo taping of the same muscle.~     After 30 minutes, the volunteers will be submitted to the same evaluation tests. Analysis:~     Intra-group and inter-group analyses of the results will be performed. Statistical tests~     will be conducted considering a 5% significance level.~   "
37901|NCT02560948|"~     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.~     The purpose of this study is to demonstrate the clinical efficacy and safety of a~     subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic~     rhinoconjunctivitis compared to placebo.~   "
37902|NCT02560935|"~     The overall goal of this proposal is to conduct a partial double-blind randomized Phase III~     clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in~     sub-Saharan Africa.~   "
37903|NCT02560922|"~     This study will examine the effectiveness of an 11-session, culturally enhanced,~     telephone-based pain coping skills training program among African Americans with hip or knee~     OA. The study team will enroll n=248 African Americans with hip or knee OA. The participants~     will be randomized into two groups. One group will take part in an 11-week pain CST~     intervention. The other group will be a wait list that receives the pain CST program after~     completing all follow-up study measures. All study participants will be able to continue any~     other usual medical care for their OA during the study period. The pain CST intervention~     includes 11 individual sessions with a study counselor, delivered via telephone to enhance~     access and reach. The sessions include the following: general information about why pain~     coping skills training is important, training in specific pain coping skills (such as~     progressive muscle relaxation, communication, imagery, and activity pacing), and guided~     practice with each skill. The CST program will also include information about other~     behaviors important for OA, such as physical activity and weight management. The main study~     outcome will be the pain subscale of the Western Ontario and McMasters Universities~     Osteoarthritis Index (WOMAC). Other outcomes will include the WOMAC function subscale,~     Coping Strategies Questionnaire, Arthritis Self Efficacy Scale, depressive symptoms,~     Health-Related Quality of Life, and Patient Global Impression of Change.~   "
37904|NCT02560909|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for~     transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity.~     There are no studies that define the effect of adjuvanted vaccine in this population. The~     purpose of this study is to determine if a vaccination with FLUAD® results in improved~     immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will~     be assessed by standard quantitative antibody titer assessments and using cell-mediated~     immunity measurements.~   "
37907|NCT02560870|"~     Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the~     treatment of Periodontal diseases.~      Methods &Material: 32 patients were selected, the following periodontal parameters were~     recorded at baseline, and after recording all the parameters at the baseline, Scaling, root~     planning, and polishing are done for all the patients participating in the study. Oral~     hygiene instructions were given that included brushing twice a day with a soft brush, After~     2 weeks, patients in the study, were randomly (Balanced Block Randomization) equal divided~     into 2 groups;~      Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic~     Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in~     one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal~     parameters, and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.~   "
37908|NCT02560857|"~     The study will prospectively determine the clinical utility of non-pathogen specific~     cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of~     immunosuppression. The investigators will use the results of the assay to predict whether~     patients develop opportunistic infections and predict organ rejection.~   "
37909|NCT02560844|"~     This study will evaluate the prognostic utility of novel ECG markers of electrical~     instability in patients with cardiomyopathy.~   "
37910|NCT02560831|"~     Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia,~     rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle~     strength and postural balance, however benefits from association with pompage is not known.~     This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and~     postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized~     controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee~     osteoarthritis, randomized into two groups with 11 participants each. Intervention group~     held strengthening exercises for flexors and knee extensors, balance training, and manual~     knee pompage for 12 weeks. Control Group received educational lectures. Arthralgia was~     estimated by pain subscale of the questionnaire Western Ontario McMaster Universities~     Osteoarthritis Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer~     HUMAC® NORM Testing & Rehabilitation System and the postural balance by the Biodex Balance~     SD postural stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t~     test was used for statistical analysis.~   "
37911|NCT02560818|"~     This is a case-control study of molecular diagnostics.~      This study requires two steps:~        -  The first part of the study will be conducted on a population of 10 women without~          breast cancer and, or ovarian family (Healthy Volunteers controls)~        -  The second part of the study will be conducted on a population of 50 patients~          predisposed to familial breast and, or ovarian cancer compared to 10 controls .~      For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL~     study, ID-RCB 2009-A00833-54) will be used.~   "
37912|NCT02560805|"~     The purpose of this study is to find out why patients with post-traumatic stress disorder~     (PTSD) have an increased risk for heart disease and high blood pressure later in life. A~     second purpose is to find out what causes PTSD patients to have high adrenaline levels~     during stress. This study will also test if a medicine called losartan improves high~     adrenaline levels in patients with PTSD and if a certain gene that has to do with high blood~     pressure might be associated with high adrenaline levels.~   "
37913|NCT02560792|"~     The primary goal of this study is to determine experimentally the relationship between~     affective response to exercise and future exercise behavior. A secondary goal is to examine~     potential mediators and moderators of this relationship, specifically four variables~     considered to contribute to the volitional control of exercise behavior - planning,~     attention, resource commitment, and affect regulation. An additional goal is to examine how~     symptoms of depression might influence the affective response to exercise, and the~     relationship between affective response to exercise and exercise behavior.~   "
37914|NCT02560779|"~     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a~     recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with~     hepatocellular carcinoma. Up to 18 patients will be treated.~      The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular~     carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.~   "
37915|NCT02560766|"~     The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600~     mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs~     Syndrome (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe~     primary RLS.~   "
37916|NCT02560753|"~     The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate~     Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will~     be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET~     imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function~     (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959.~      An expanded access extension is planed to provide access to study medication to subjects who~     have completed the main study and requested continued use.~   "
37917|NCT02560740|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often~     irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the~     hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40~     percent of patients undergoing chemotherapy.~      American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology~     (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.~      PerOx Quench has unique membrane protection and anti-oxidative function as a special food,~     that's why to try to explore its preventive effects on CIPN prevention induced by~     Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.~   "
37918|NCT02560727|"~     No technique by placing a tube through anus into cecum for whole colon administration. This~     study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral~     tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.~   "
37919|NCT02560714|"~     The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to~     evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief~     of SI joint pain symptoms.~   "
37925|NCT02560636|"~     PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an~     immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study~     will also investigate two different doses of pembrolizumab, starting at 100mg (through an~     intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose~     is well tolerated. The patients suitable for this study will be: Group A those with locally~     advanced bladder cancer or Group B patients whose cancer has spread from the bladder~     (metastatic bladder cancer).~      Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a~     course of 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three~     weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless~     they have disease progression or unacceptable side effects in the meantime. Patients in~     Group B will continue taking pembrolizumab for as long as needed until they have disease~     progression or unacceptable side effects.~      Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT~     scans will be done every 3 months during treatment and as per usual care (usually 6 monthly)~     after the treatment has finished. Patients in Group A will also have a cystoscopy (camera~     test) to look into the bladder 3 months after they finish radiotherapy. This is standard~     care and would be the same for patients not on a research study.~   "
37926|NCT02560623|"~     This study will evaluate if the capsule sponge device can detect the presence of Barrett's~     Esophagus~   "
37927|NCT02560610|"~     The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma~     control in subjects with severe, refractory eosinophilic asthma.~   "
37928|NCT02560597|"~     The purpose of this study is to assess the effects of repetitive transcranial magnetic~     stimulation (rTMS) as a treatment for Epilepsia Partialis Continua (EPC) or refractory~     Status Epilepticus (SE), when standard clinical treatments have failed.~   "
37929|NCT02560584|"~     The purpose of this study is to investigate if blue light cystoscopy with Cysview improves~     detection of tumors in patients with bladder cancer during surveillance cystoscopy, using~     the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate~     if Cysview and blue light is safe and effective when used repeatedly.~   "
37930|NCT02560571|"~     The study evaluates pre-operative prediction of the risk for lymph nodes involvement in~     endometrial cancer patients. Patients will undergo ultrasound exam (bi and three~     dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory~     exams, before surgery.~      The sonographic evaluation will include endometrial characteristics and myometrial invasion,~     pelvic findings and enlarged lymph nodes.~   "
37931|NCT02560558|"~     The purpose of this study is to transition patients who have been stable on Belatacept for~     one year after kidney transplant from standard 4-week to an investigational 8-week~     belatacept dosing schedule. The investigators hypothesize that renal function and acute~     rejection rates will be non-inferior with 8-week belatacept dosing.~   "
37932|NCT02560545|"~     Effective treatment of acute pain, chronic and persistent is the most important concern in~     the world today. Although a variety of pain medications including anti-inflammatory~     painkillers and opiouids, patients continue to suffer from pain constantly. For over a~     century ,International committees studied the issue of cannabis, and almost uniformly~     recommended the use of cannabis for various medical applications ,especially those that~     include pain treatment.~      Despite the widespread use of THC in clinical practice, there are few studies on the~     efficacy of THC In a double-blind, randomized trial. In addition, few studies examined the~     effect of THC on the experience pain in healthy subjects and most of them did not find an~     effect on pain experimental induced by capsain. so checking other models of pain such as~     thermal pain and mechanical pain in addition to checking the influence on the regulation of~     pain will contribute to understanding the mechanism of action of THC. Understanding the~     mechanism of action of THC in relieving pain will lead to predicting who will benefit from~     this treatment and direct patients for selection of appropriate medication according to the~     damaged mechanism.~   "
37933|NCT02560532|"~     The purpose of this study is to evaluate the safety and potential therapeutic benefit of use~     of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain~     due to the presence of blood in the space around the brain) in patients who have suffered a~     condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of~     the brain from a ruptured brain aneurysm~   "
37934|NCT02560519|"~     Colloid solutions are widely used for volume replacement therapy because of their high~     oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only~     colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant~     plasma protein, it has physiological importance in the well-being of the endothelial~     glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin~     over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither~     renal function nor coagulation, but their volume expanding effect is questionable.~      For several reasons (use of heart-lung machine, systemic inflammation, coagulation~     disturbances), patients undergoing cardiac surgery need especially large amounts of fluids.~     However, there are no large trials comparing albumin solutions to crystalloid solutions~     cardiac surgery.~      This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery~     patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate~     solutions for both priming of the heart-lung machine and perioperative volume replacement~     therapy. The primary efficacy and safety endpoint of this study is the incidence of major~     adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute~     myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke,~     certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation,~     acute kidney injury within 90 days postoperatively. The secondary outcomes are total number~     of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product~     transfusions, blood loss, acute kidney injury, days alive without mechanical~     ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for~     biochemical analyses will be collected at four perioperative time points.~      This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery~     patients. The biochemical mechanisms of albumin will be assessed.~   "
37935|NCT02560506|"~     The goals of this Model System Program are to expand upon and advance the findings and~     outcomes of previous and current Model Systems clinical research, to continue to develop and~     study the effectiveness of innovative treatment strategies for persons with spinal cord~     injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated,~     interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI.~     In order to achieve these goals, the following objectives of the Midwest Regional Spinal~     Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.~   "
37936|NCT02560493|"~     The goal of the proposed randomized controlled trial is to test the efficacy of exergaming~     (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and~     obese children.~   "
37937|NCT02560480|"~     The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This~     observational case-control study follows three contact sport teams (soccer, ice-hockey and~     bandy) for two years to find out the prevalence and reasons for groin pain. Clinical~     examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and~     groin questionnaire (HAGOS) is used to determine severity of groin injuries.~   "
37938|NCT02560467|"~     The objective of this study is to determine whether myocardial contrast echocardiography in~     patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or~     stress induced perfusion defects due to associated abnormalities in intramyocardial arteries~     and the microcirculation. A secondary aim will be to determine whether abnormalities in~     perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence~     of arrhythmias, and regional function of the septum.~   "
37939|NCT02560454|"~     ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed~     as an intervention for ADHD that targets cognitive deficits, with specific exercises through~     intensive training sessions. This intervention is based on principles of brain plasticity~     and cerebral functional reorganizations.~      Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working~     memory training is the most commonly used and studied cognitive training program in clinical~     practice and research. It is clear from most studies that Cogmed training program increases~     working memory in ADHD. However, transfer of learning is not demonstrated on: other~     cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic~     achievement.~      In addition to this type of intervention multi-factorial program targeting different~     cognitive function as Presco also exist but have been less studied.~      To address these challenges, this study will follow a randomized and controlled design.~      The main objective of this study is to examine the impact of cognitive training in~     comparison with a control waiting-list group among children with ADHD on:~        1. ADHD symptoms,~        2. cognitive functioning,~        3. attentional capacities~        4. academic achievement.~      The second objective is to compare two types of cognitive training a unifactorial program~     Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive~     functions affected by ADHD.~      Long-term effects are examined six months after training. Participants (n=90) will be~     randomly assigned to the two experimental group (Cogmed or Presco) or to the control group~     waiting list. Participants will be evaluated three time (time 1) just before the~     intervention, (time 2) six weeks after the first evaluation, immediately after the~     intervention and (time 3) six months after the intervention.~   "
37940|NCT02560441|"~     The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage~     II disease (only referring to patients with the invasion of Waldeyer's ring and cervical~     lymph nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy~     followed by radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP~     regimen for both arms are 3 cycles. And the chemotherapy is repeated every 3 weeks..~      The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL~     patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is~     repeated every 3 weeks.~   "
37941|NCT02560428|"~     The purpose of this study is to evaluate approximately eight grants that will test~     interventions to improve cardiovascular disease prevention. The investigators will collect~     and analyze qualitative data to identify the most effective combinations of intervention~     strategies. The investigators will observe grantees and selected practices to understand why~     and how those combinations are effective. The investigators will also gather data from the~     grantees to assess how effective the interventions are.~   "
37942|NCT02560415|"~     To meet the required intensive intervention hour for treating children with autism spectrum~     disorder (ASD), the investigators developed an automated serious gaming platform (11 games)~     to deliver intensive intervention at home (GOLIAH). The major objective of the study is to~     test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the~     usefulness and acceptability of the gaming platform; (2) how experimental children performed~     using the different Imitation and JA games; and (3) whether children from the experimental~     group improved significantly more than children treated as usual (control group).~   "
37943|NCT02560402|"~     Aim of the present study is to determine whether~        1. RRI can predict glomerular hyperfiltration;~        2. glomerular hyperfiltration is associated with low renal resistive index;~        3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the~          sublingual microcirculation;~        4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with~          bioimpedance analysis.~   "
37944|NCT02560389|"~     The purpose of this study is to investigate a new use for a medication called levodopa~     (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for~     Posttraumatic Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive~     abilities that the investigators believe may be affected among women with PTSD. It is~     hypothesized that L-DOPA may enhance fear extinction learning to a conditioned fear~     stimulus. If this is true, L-DOPA may improve outcomes for those undergoing certain types of~     therapy for PTSD, though that aim is beyond the scope of this project. Additionally, the~     investigators are testing whether an individual's genetic profile affects how well L-DOPA~     works to enhance cognitive abilities.~   "
37945|NCT02560376|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in~     insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq)~     68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will~     be used to assess the PET/CT images.~   "
37946|NCT02560363|"~     This is an open-label, randomized, cross over single oral dose study to compare the~     pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in~     Part B in healthy male subjects~   "
37947|NCT02560350|"~     Human adipose tissues were obtained from five healthy adult women who underwent abdominal~     liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or~     endocrine diseases. Ten millilitres of discarded adipose tissue from the humans was used to~     gain the adipose-derived stem cells. In this study, the investigators will evaluate the~     potential of a small intestinal submucosa scaffold combined with adipose-derived stem cells~     to form an adipocyte-containing hypodermis.~   "
37971|NCT02560038|"~     This trial is for people with bladder cancer that has spread. The purpose of this research~     study is to see if the chemotherapy combination of gemcitabine and cisplatin plus paclitaxel~     is safe and effective treatment for bladder cancer.~      Paclitaxel, gemcitabine and cisplatin have all been approved by the United States Food and~     Drug Administration (FDA). Gemcitabine and cisplatin is a standard treatment for bladder~     cancer. There have been studies that show that paclitaxel and cisplatin have antitumor~     activity in bladder cancer. European researchers studied paclitaxel, gemcitabine and~     cisplatin (same drug combination in this trial) and found that the combination provided good~     disease control and was well tolerated. Investigators are studying the same drug~     combination, but at different dosages and schedule.~   "
37948|NCT02560337|"~     Many ovarian cancer patients have been offered different standard cytostatics and gradually~     develop chemo-resistance. However, a considerable fraction of these patients are still in~     good general health and have a strong wish for further treatment.~      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both~     tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be~     anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.~      Tocotrienol is a fraction of the natural E-vitamin with several biological effects,~     including effect on malignant cells and angiogenesis.~      The aim of the study is to investigate whether cabazitaxel and tocotrienol could be~     reasonable treatment options in patients with chemo-resistant and refractory ovarian cancer~     with regard to effect and toxicity.~      In case of progression on cabazitaxel there is an option of crossing over to tocotrienol and~     vice versa.~   "
37949|NCT02560324|"~     This is a randomized, double-blind, placebo-controlled crossover study to test whether a~     medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it~     reduces sleep problems that smokers experience during a quit attempt.~   "
37950|NCT02560311|"~     The aim of this study is to analyze cases of human epidermal growth factor receptor (HER)~     2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of~     Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to~     find out associations between different variables and the outcome. The aim is to find out~     probable prognostic factors and patterns of disease progression. Prognostic factors could~     optimize treatment approaches and result in a delay of disease progression.~   "
37951|NCT02560298|"~     This randomized phase II trial studies how well cisplatin and fluorouracil work compared~     with carboplatin and paclitaxel in treating patients with anal cancer that cannot be removed~     by surgery, has come back at or near the same place as the primary tumor, or spread to other~     places in the body. Drugs used in chemotherapy, such as cisplatin, fluorouracil, carboplatin~     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether cisplatin and fluorouracil are more effective than carboplatin and paclitaxel~     in treating anal cancer.~   "
37952|NCT02560285|"~     Over time there is a need to improve old and develop new risk models. Overall the assessment~     of mortality risk in cardiac surgery is performed with the use of preoperative risk models.~     The use of improved risk models and increased accuracy in the technique of preparing these~     mathematical systems does not have a positive impact on the level of prediction, which is~     still inaccurate, especially in the considered group of high risk. New models need to be~     built not only for a better prediction of mortality risk, if not also to predict morbidity~     in the group of patients at higher risk of complications after cardiac surgery procedures.~      The aim of this study is:~        -  To construct the HiriSCORE to identify patients at higher risk of complications after~          cardiac surgery procedures~        -  Assessing the impact of pre-, intra- and postoperative period to the prognosis of~          morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.~   "
37953|NCT02560272|"~     The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b~     conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been~     previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses~     of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children~     1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1~     month apart.~   "
37954|NCT02560259|"~     The role of referred pain from the retro trochanteric region, in patients with knee pain.~     Defining and quantifying this sub group of knee patients in the investigators list of~     refered knee patients. Evaluating the effect of treatment. A randomized trial.~   "
37955|NCT02560246|"~     The purpose of this study is to determine whether diet and the gut microbiome play a role in~     spontaneous preterm birth (SPTB), namely delivery of the fetus prior to 37 weeks gestation.~   "
37956|NCT02560233|"~     The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic~     Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating~     neural, endocrine, and subjective reactivity to psychosocial stress.~   "
37957|NCT02560220|"~     A phase- I clinical trial to determine safety and feasibilty of intravenous administration~     of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic~     kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a~     kidney transplant from a living donor.~   "
37958|NCT02560207|"~     This study evaluates target attainment after either intermittent intravenous bolus or~     intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill~     patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.~   "
37959|NCT02560194|"~     Guaiac faecal occult blood testing (gFOBT) consistently demonstrates reductions in deaths~     from colorectal cancer of around 16% and gFOBT screening is now routine in all four~     countries of the United Kingdom. However, gFOBT has significant limitations and is~     associated with a substantial interval cancer rate in the region of 50 %, indicating a~     severe deficiency in sensitivity for cancer. Additionally, as the majority of colorectal~     cancers arise from pre-existing adenomas, it is important for colorectal screening~     programmes to detect adenomas in order to reduce the incidence of the disease as well as the~     associated mortality. Although gFOBT does detect some adenomas, most randomised trials have~     not demonstrated a reduction in colorectal cancer incidence. Also, FOBT screening tends to~     under-detect cancers in women and it is relatively insensitive for rectal cancer when~     compared with colon cancer.~      Single flexible sigmoidoscopy (FS), between the ages of 55 and 65 years, has been shown to~     bring about a significant reduction in colorectal cancer mortality. In addition, and most~     importantly, after a period of four years a significant reduction in colorectal cancer~     incidence was observed. FS does not suffer from low specificity since false positives do not~     occur, and there is independent evidence that it is more sensitive than a single gFOBT. In~     addition, FS is ideally suited to detecting rectal cancers and adenomas, and it is unlikely~     that there would be a gender difference in the sensitivity.~      Single FS has not been compared with biennial FOBT and there is no information regarding the~     utility of FS in a population that has already been exposed to FOBT screening. It is~     hypothesised that offering a combination of gFOBT and FS would provide an enhanced screening~     algorithm that would be associated with better outcomes than gFOBT alone. In order to test~     this hypothesis a randomised evaluation pilot study of FS screening integrated into the~     current gFOBT Screening Programme, will be carried out in those around age 60, as this~     appears to be the age at which adenoma prevalence peaks.~   "
37997|NCT02559687|"~     In this study participants with advanced/metastatic adenocarcinoma or squamous cell~     carcinoma of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the~     gastroesophageal junction (GEJ) previously treated with two standard therapies will be~     treated with pembrolizumab~   "
37960|NCT02560181|"~     Radiation therapy is considered a standard treatment option for the management of localized~     prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the~     optimal salvage therapy. Salvage options available for isolated local recurrence include;~     temporary or permanent implantation of radioactive seeds into the prostate, complete removal~     of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high~     frequency ultrasound to treat the disease. There are risks of complications associated with~     all these treatments, and there is presently no consensus as to which treatment is the best.~     The aim of this pilot study is to look at the feasibility and toxicities of whole gland~     salvage treatment of the prostate using temporary implantation of radioactive seeds into the~     prostate.~   "
37961|NCT02560168|"~     1. The MyoVista device is capable of detecting surface electrocardiogram signals and~          sensitive in detecting coronary artery disease compared to traditional computed~          tomography angiography (CTA)~        2. Electrophysiological signals at the cellular level of myocardium are related to~          specific patterns on the MyoVista device~        3. Changes in MyoVista device output and can indicative of future CAD outcomes and need~          for revascularization~   "
37962|NCT02560155|"~     Surgical site infections are a major postoperative complication and are mostly due to~     colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis~     or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a~     trend in lowering surgical site infection rates, but especially in orthopedic surgery data~     is controversial and randomized controlled trials are lacking. In the main study, the study~     investigators aim at performing a controlled prospective randomized interventional trial to~     measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on~     surgical site infection rates in orthopedic surgery. In an alongside study a controlled~     prospective randomized interventional trial to measure the impact of preoperative skin~     decolonization of patients undergoing an orthopedic procedure will be conducted.~   "
37963|NCT02560142|"~     This is a single center non-interventional study in healthy participants for behavioral~     assessment and functional magnetic resonance imaging (fMRI) assessments. The study will~     consist of 2 parts. Part A will involve 5 participants and will study the implementation of~     the behavioral tests and identify potential issues. Part B will involve 30 participants and~     will study the test-retest reliability. Duration of participation for each participant will~     be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for~     Part B (28 days screening period and 2 study visits of 2 days each separated by a period of~     14 days).~   "
37964|NCT02560129|"~     Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive~     critical illness. However, there is no data regarding long-term follow-up for ICU survivors.~     The investigators have begun the implementation of an ICU recovery clinic.~      Rationale:~      ICU survivors are at high risk for functional, cognitive and psychiatric impairments.~     However, methods to mitigate these impairments and improve recovery are lacking. Special~     follow-up clinics for survivors of critical illness have been proposed and implemented to~     some degree, but are uncommon.~   "
37965|NCT02560116|"~     The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP)~     measurements obtained with and without echocardiographic contrast (Optison) during~     transthoracic echocardiography (TTE) with those obtained invasively and simultaneously~     during right heart catheterization, as the gold standard.~   "
37966|NCT02560103|"~     Observational study to investigate circadian rhythm patterns~   "
37967|NCT02560090|"~     Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be~     eligible for a clinical research study to improve diabetes self-management and decrease~     hospital re-admissions.~      The purpose of this study is to compare the effectiveness of three hospital discharge~     follow-up methods:~        1. standard of care,~        2. a nurse telephone intervention (care coordination and education), and~        3. an in-home community health worker intervention (care coordination and education).~   "
37968|NCT02560077|"~     Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of~     cashew or cashew apple may be consumed fresh, but contains high quantities of tannins~     yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as~     beverage. It is rich in carbohydrate and vitamin C. It is also claimed for numerous ailments~     including antitumor, antimicrobial, urease inhibitory and lipoxygenase activity. In~     addition, cashew apple juice also has excellent anti-oxidant potential. The preclinical data~     also demonstrated that cognitive deficit rats induced by cholinotoxin which received~     A.occidentale or cashew fruit juice for 2 weeks showed the neuroprotective and cognitive~     enhancing effects.Therefore, the potential benefit of Cashew apple juice on physical fitness~     and psychological fitness of the middle aged and elderly is focused.~   "
37969|NCT02560064|"~     Measurement of the small bowel length studied by anatomists, surgeons and radiologists.~     Results were highly different among these series. Technical and mechanical factors have~     major effects on measures. Investigators decided to reach a standardization for the~     measurement of small bowel length.~   "
37970|NCT02560051|"~     This study is for men who have prostate cancer and have failed local therapy or are not a~     candidate for prostatectomy or radiation therapy. The purpose of this research study is to~     assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus~     chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin,~     Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The~     drugs used in this study are approved by the Food and Drug Administration (FDA).~      Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week~     cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the~     number of months they receive ADT will be based on their disease. The current standard~     treatment is ADT and chemotherapy. What differs in this research study is the cycling and~     combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side~     effects and are believed to provide maximum benefit.~   "
37998|NCT02559674|"~     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with~     advanced pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.~   "
37972|NCT02560025|"~     This research study is studying a targeted therapy (a form of treatment that uses drugs or~     other substances to identify and attack specific types of cancer cells with less harm to~     normal cells) as a possible treatment for high-risk acute myeloid leukemia.~      The names of the study interventions involved in this study are:~        -  Alisertib / MLN8237~        -  Cytarabine / Cytosine Arabinoside~        -  Idarubicin / Idarubicin hydrochloride~        -  Daunorubicin (Can be used in place of idarubicin)~   "
37973|NCT02560012|"~     This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug~     Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and~     two for second-line therapy. Each of these drugs targets a specific molecular pathway. At~     present oncologists select therapy based on current guidelines. There is a new method for~     trying to use biomarker information from the subject's tumor to select the best drug to~     treat the subject. This process is investigational, which is why this study is being done.~      Biomarkers are genes, proteins and other molecules that affect how cancer cells grow,~     multiply, die and respond to other compounds in the body. These biomarkers build a tumor~     profile or fingerprint of the subject's tumor. A new focus in cancer care is personalized~     treatment, where doctors select a drug based on the subject's tumor's unique fingerprint~     which is more likely to be effective in fighting the tumor. Selecting the treatment the~     subject is more likely to respond to requires a thorough understanding of the relationship~     between biomarker and treatment effect. The PI wants to gather data to understand that~     relationship to help treat future cancer patients. The purpose of this study is to evaluate~     efficacy of treatments that are selected based on tumor profiles.~   "
37974|NCT02559999|"~     Determine objective markers of pain perception remains a major scientific and medical issue.~     Various tools have been proposed to objectify pain, but their adaptability to different~     clinical contexts are limited. Our working hypothesis considers that the research for~     markers of immediate pain perception should be based on an electrophysiological approach,~     based on the combined analysis of EEG and autonomic responses.~   "
37975|NCT02559986|"~     Postpartum depression (PD) is a serious and disabling mental health condition that affects~     10-15% of women after childbirth. Low-income minority women are disproportionately affected.~     Untreated PD can lead to significant negative outcomes for both mother and child.~     Pediatricians are being asked to routinely screen for PD and while screening rates are~     improving, little is known about whether mothers actually adhere to pediatrician~     recommendations to seek additional help after a positive PD screen. The objective of this~     study is to describe the rate at which mothers seek treatment for suspected PD after a~     positive screen at the pediatrician office. Additional examination will look at factors that~     predict whether a mother recalls a recommendation to seek treatment.~   "
37976|NCT02559973|"~     This is a single-center, randomized, open-label, single-dose, parallel-group study which~     will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid~     use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential~     (Inpatient) and Non-Residential (Outpatient) Period.~   "
37977|NCT02559960|"~     This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify~     the potential risk factors for the adverse drug reactions.~   "
37978|NCT02559934|"~     The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing~     2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of~     solamargine in subjects with AK while administration of a 25 cm2 contiguous or~     non-contiguous dermal treatment area.~   "
37979|NCT02559921|"~     This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and~     tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells)~     in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only,~     rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine~     for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20~     IU/kg）in combination with rabies vaccine for human use,and placebo in combination with~     rabies vaccine for human use,respectively.~   "
37980|NCT02559908|"~     This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable~     gel for the restoration and creation of facial volume in participants seeking to increase~     projection of the chin and/or jaw.~   "
37981|NCT02559895|"~     The purpose of this study is to assess ALD403 in the prevention of migraine headache in~     frequent episodic migraineurs.~   "
37982|NCT02559882|"~     The study aimed to assess the success of a clinically indicated renal denervation by~     different tests and correlate the results of the tests with the clinical outcome.~   "
37983|NCT02559869|"~     This is a multicenter, 18-month study, which aims to identify imaging and biofluid~     biomarkers in people with ALS to expand the understanding of ALS pathology, treatment~     targets, disease progression, and anatomical differences between different disease~     phenotypes. This pilot project is tailored to produce imaging tools that will allow~     researchers to conduct future ALS clinical trials more efficiently which may in turn impact~     the pace for ALS drug discovery.~   "
37984|NCT02559856|"~     This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood~     thinners for the treatment of blood clots. Half of the patients will receive apixaban and~     half will receive rivaroxaban. The main objective is to determine the feasibility of patient~     recruitment and resources required to follow enrolled patients and inform for a larger,~     multi-centered trial and to assess which one is safer.~   "
37985|NCT02559843|"~     Introduction: Diabetes mellitus a chronic diseases, is the most common and important~     metabolic disease in human. Increased free radicals production due to hyperglycemia produces~     oxidative stress which worsens the disease and its complications. Pomegranate juice has~     antioxidant and antiatherosclerotic properties. The present study was planned to evaluate~     the effects of pomegranate juice consumption on glycemic control, lipid profile,blood~     pressure and oxidative stress in patients with type 2 diabetes~   "
37986|NCT02559830|"~     Evaluating the safety and efficacy of Lentiviral Hematopoietic Stem Cell Gene Therapy for~     advanced stage of Metachromatic Leukodystrophy and adrenoleukodystrophy.~   "
38304|NCT02555683|"~     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared~     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA~     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all~     patients with severe asthma).~   "
37987|NCT02559817|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.~      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.~     Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will~     receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria~     will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages~     12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or~     placebo for 4 weeks.~      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as~     well as other bowel symptoms of IBS-C.~   "
37988|NCT02559804|"~     To describe the natural history of peripheral neuroblastic tumour presenting with SCI and~     evaluate the combined effects of different risk factors on the eventual neurologic and~     orthopaedic outcomes~   "
37989|NCT02559791|"~     The steroid sparing effect of anti interleukin (IL-5) monoclonal antibody has been proven,~     but the effectiveness of subcutaneous (SC) compared to intravenous (IV) administration of~     these drugs to suppress airway eosinophilia is still under debate. As part of a previous~     study, 100mg of mepolizumab were administered subcutaneously to a group of subjects with~     prednisone-dependent eosinophilic asthma. Despite this intervention, 50% of the subjects (15~     patients participated in this study) had persistently elevated sputum eosinophil counts. The~     same 15 patients will be invited to participate in the current study, and if they provide~     their informed consent, will receive 2 monthly doses of placebo, followed by 4 monthly doses~     of IV reslizumab. The primary outcomes are blood and sputum eosinophils, and the secondary~     outcomes include sputum and blood Innate lymphoid cell-2 (ILC2) cells, cluster of~     differentiation 4 (CD4+) cells, cluster of differentiation-8 (CD8+) cells, cluster of~     differentiation-34 (CD34+), Eosinophil-Basophil cluster cells (Eo/B progenitor cells),~     forced expired volume in 1 second (FEV1), asthma control questionnaire (ACQ) and number of~     eosinophilic exacerbations. Measurements of the outcomes will be done before placebo, after~     placebo and after IV reslizumab. This study design will determine whether IV reslizumab is~     effective in suppressing airway eosinophilia in prednisone-dependent patients.~   "
37990|NCT02559778|"~     A prospective open label, multicenter study to evaluate the feasibility and acute toxicity~     of using molecularly guided therapy in combination with standard therapy followed by~     maintenance therapy with DFMO in subjects with newly diagnosed high risk neuroblastoma.~   "
37991|NCT02559765|"~     This survey will investigate the views of people with progressive MS in terms of~     physiotherapy services. In particular the study will examine the proportion of people with~     progressive MS on the MS register who use physiotherapy services, how worthwhile they think~     it is for them and how they would like their physiotherapy to be delivered. This survey will~     also explore how physiotherapy services for people with progressive MS varies across the UK~     and what other types of rehabilitation services are currently used by people with~     progressive MS.~   "
37992|NCT02559752|"~     This study will explore neurocognitive performance in pediatric brain tumor patients~     receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline~     neurocognitive testing prior to the completion of the first week of radiation therapy along~     with follow-up testing 6-12 months after the completion of radiation and serial annual~     testing thereafter. With these data the investigators plan to evaluate the effects of PBRT~     on neurocognitive performance as it relates to patients' age at diagnosis, tumor location,~     and radiation dose. Modeling studies have demonstrated that PBRT could improve~     neurocognitive outcomes, but there is a paucity of prospectively-collected patient data. The~     investigators are uniquely positioned to address this important question given the busy~     pediatric central nervous system (CNS) tumor service, the delivery of proton therapy at the~     S. Lee Kling Proton Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary~     research team with extensive experience into the late effects of therapy as it relates to~     neurocognition.~   "
37993|NCT02559739|"~     Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered~     breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and~     cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders~     are frequent after stroke and detrimental for stroke outcome. However, more prospective~     studies in a large unselected sample of stroke survivors are needed to better investigate~     the short- and long-term consequences of sleep disturbances on mortality and occurrence of~     new cardio-cerebrovascular events. Also their pathophysiological mechanisms and their~     influence on stroke recovery should be better understood.~      Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep~     fragmentation on the frequency of new cerebro- and cardiovascular events and death after~     stroke or transient ischemic attacks, and clinical outcome within one and two years after~     stroke.~      The working hypotheses are that stroke survivors with sleep deficiency and sleep~     fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will~     present: (1) higher mortality from all causes and higher frequency of new cardio-/~     cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared~     between patients with and without sleep deficiency and fragmentation.~      Since current clinical practice in cerebrovascular patients does not sufficiently consider~     sleep disorders in patient's management, this study can help to bring attention to a still~     overlooked medical problem and change the current standard of management of stroke~     survivors.~   "
37994|NCT02559726|"~     Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract~     gradient of 30 mmHg or more under resting conditions is an independent determinant of~     symptoms of progressive heart failure and death.~      The investigators hypothesize that the electrical approach by dual chamber pacing could~     improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected~     patients with a mechanical hyper-synchronicity. The aim of the study is to identify and~     describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction~     thanks to innovative multi-imaging approach.~   "
37995|NCT02559713|"~     The purpose of this study is to assess the concentration of vedolizumab in breast milk of~     lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are~     receiving vedolizumab therapeutically.~   "
37996|NCT02559700|"~     This study is an open trial investigating the long-term use of an online brain training~     programme for adults over 50. It will determine whether there is sustained benefit to~     cognition, and whether this group can be engaged in this form of intervention over a period~     of 12 months.~   "
37999|NCT02559661|"~     Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation~     where the surgeon requires much training and where there is an increased risk of operative~     complications in the early stage. For this reason, virtual surgery is suited to help~     training and subsequent maintenance of operational skills [1, 2].~      There are no previously published research in virtual vitreoretinal surgery, but this is~     nevertheless vital to better surgical training.~      Many surgical disorders - such as retinal detachment - progresses with time, and it is often~     not known when to ideally operate [3]. On one hand, it may be best to operate early and~     thereby reduce the risk of disease progression before surgery. On the other hand, it is also~     important to take into account factors such as the presence of the correct operational~     expertise as well as the surgeon's fatigue and stress levels. These mentioned matters is~     difficult to test clinically. With virtual surgery it will be possible to introduce various~     operational distractions and see what impact it has on operating performance.~      The purpose of the study 'Virtual vitreoretinal surgery: construction of a training program~     and analysis of significant factors for operating performance' is 1) to facilitate the~     training of future vitreoretinal surgeons by introducing a virtual training program with~     high construction validity, and 2) to clarify which external conditions affects the~     performance of trained operator using the virtual training program.~   "
38000|NCT02559648|"~     This is a single-site, randomized, placebo-controlled, double blind phase 2b clinical trial.~     Patients with Thalassemia will participate in this study and will be treated with Denosumab~     or placebo. The effect of Denosumab on lumbar spine BMD in patients with Thalassemia Major~     and Osteoporosis will be evaluated as compared with control (placebo) at 12 months.~   "
38001|NCT02559635|"~     Postoperative ileus is the most commonly observed morbidity following ileostomy closure.~     Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy~     undergoes a series of functional and structural changes. It has been hypothesized that these~     changes may contribute to the development of postoperative ileus, and that stimulating the~     distal limb of a loop ileostomy prior to closure may functionally prepare the excluded bowel~     for intestinal transit.~      The purpose of the multicenter, randomized controlled trial is to determine the impact of~     preoperative stimulation of the distal limb of a loop ileostomy on postoperative ileus.~   "
38002|NCT02559622|"~     The purpose of this study is to explore the effect of treatment with 300 mg or with 150 mg~     secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on~     endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in~     subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers will be assessed~     to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging~     (MRI) will be performed in a subpopulation to assess the treatment effect on arterial vessel~     wall morphometry in atherosclerosis prone vascular beds.~   "
38003|NCT02559609|"~     Despite recent improvements in the US economy, unemployment remains a significant concern,~     and estimates indicate that one-third of unemployed persons drink at hazardous levels,~     adversely impacting their health and abilities to find jobs. Reinforcement interventions are~     highly efficacious in reducing substance use, and they can be applied to increase~     job-seeking activities as well. In partnership with CT United Labor Agency, this project is~     designed to reduce hazardous drinking and enhance active participation in job-seeking~     activities among those with job loss. It will evaluate the independent and combined effects~     of reinforcing negative breathalyzer samples and job-seeking activities to ascertain the~     simplest and most cost-effective approach to improving outcomes in this population.~     Unemployed individuals with hazardous drinking (N = 280) will be randomly assigned to one of~     four conditions using a 2 x 2 design: standard care, standard care with reinforcement for~     submitting negative breathalyzer samples, standard care with reinforcement for job-seeking~     activities, or standard care plus reinforcement for both negative breathalyzer samples and~     job-seeking activities. Participants in all conditions will receive usual services part of~     CT United Labor Agency, along with a novel remote breath alcohol monitoring procedure. The~     study interventions will be in effect for three months, and participants will be followed~     for one year. Alcohol and other drug use, employment, psychiatric symptoms, and global~     measures of health will be assessed throughout treatment and follow-up. Reinforcing negative~     breathalyzer samples is expected to significantly reduce drinking, and reinforcing~     job-seeking activities is expected to increase re-employment rates and reduce time until job~     attainment. Reinforcing both negative breathalyzer samples and job-seeking activities is~     hypothesized to improve outcomes along both domains. The reinforcement interventions may~     also decrease psychiatric distress and slow progression of physical decline, common among~     the unemployed. If efficacious and cost-effective, results from this study may stimulate~     adoption of reinforcement interventions in the context of unemployment services. Reducing~     the adverse consequences of hazardous drinking and improving job re-entry may have~     pronounced benefits in a highly vulnerable segment of the US population.~   "
38004|NCT02559596|"~     The purpose of this study is to investigate whether there is an association between stroke~     or heart attack and reactivation of varicella zoster virus, measured by antibody levels,~     using linked data from the Health Survey for England and secondary care.~   "
38005|NCT02559583|"~     The primary purpose of the study is to quantify participants' demographic parameters,~     country standard therapies, treatment patterns and outcomes among participants with chronic~     lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in~     oncology concentration hospitals in Latin America.~   "
38006|NCT02559570|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of functional constipation (FC), in children age 6-17 years This study includes up~     to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will~     receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid~     oral solution.~      Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of~     linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria~     will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.~      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as~     well as other bowel symptoms of FC.~   "
38007|NCT02559557|"~     This pilot clinical trial studies a culturally adapted skills training and educational~     intervention in guiding parents of younger acute lymphoblastic leukemia (ALL) or acute~     myeloid leukemia (AML) survivors at risk for long-term attention and memory problems (late~     neurocognitive effects). ALL and AML treatments target the central nervous system and may~     put younger survivors at increased risk for late neurocognitive effects, which may lead to~     learning difficulties or behavior problems and poor health-related quality of life.~     Spanish-speaking parents of young ALL or AML survivors may not have access to the~     information, resources, or guidance to help their children through these difficulties.~     Adapting an existing parent-training program into Spanish may help teach Spanish-speaking~     parents effective ways to prevent or reduce learning and behavioral difficulties, which may~     improve the quality of life of parents and young ALL or AML survivors.~   "
38008|NCT02559544|"~     Evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine~     refractory recurrent or metastatic breast cancer patients starting a new therapy regimen~     including endocrine targeted therapy.~   "
38010|NCT02559518|"~     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed~     once a week in a counterbalanced order and at least with seven days washout period to~     minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and~     attention levels evaluation, cortical brain activity measures through paired pulse~     transcranial magnetic stimulation (pp-TMS), handwriting test, non-invasive cerebellar~     stimulation during serial reaction time task (SRTT) and performance perception evaluation.~   "
38011|NCT02559505|"~     This study evaluates how different methods of early exposure to influenza (natural~     infection, live attenuated influenza vaccination, inactivated influenza vaccination)~     initially stimulate immunity and poise the immune system to respond to a future challenge~     with the inactivated influenza vaccine.~   "
38012|NCT02559492|"~     This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic~     solid tumors. The study will be divided into 2 parts (Part 1a and Part 1b). Part 1a will~     evaluate a JAK inhibitor with JAK1 selectivity (INCB039110) in combination with an IDO1~     inhibitor (epacadostat; INCB024360; Group A) and INCB039110 in combination with a PI3K-delta~     inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b~     doses for each combination. Once the recommended dose has been identified for each treatment~     group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion~     cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b).~   "
38013|NCT02559479|"~     The objective of the study is to assess the effect of low-calorie diets with normal (18%)~     vs. high (35%) protein (mainly coming from animal source) composition on body weight and~     carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A~     dietary intervention is carried out during 6 months in 100 subjects who are individually~     randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35%~     protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates.~     Around 80% of total protein in diet comes from animal source (of whom around 40% from lean~     red meat). Subjects are provided with weekly menus and different recipes to use them as part~     of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the~     beginning of the study, after 3 and 6 months, the following parameters are determined:~     anthropometric (weight, waist circumference, body mass index and body composition), blood~     pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total~     cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B,~     iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin).~     Urine samples are also collected to assess microalbuminuria and ureic nitrogen.~   "
38014|NCT02559466|"~     Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for~     treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS~     efficiency remains however unknown; besides local effect on the target, TMS may induce~     interaction changes between remote cerebral regions. On the other hand, few studies have~     been performed in comparison to sham placebo stimulation. The investigators recently showed~     that non-responder depressive patients to TMS exhibited deeper and wider brain functional~     abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device~     capable of inducing a magnetic field with a deeper and wider distribution than standard~     coils.~      The investigators design here a randomized controlled study in which the investigators will~     compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their~     functional neuroanatomical correlates and changes in connectivity by Positron Emission~     Tomography (PET). The general objective is to better understand the mechanisms related to~     TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic~     approach for the patient.~   "
38015|NCT02559453|"~     We have designed this study to determine whether performing two, compared with ≥3 operations~     has an effect on key clinical outcomes after discharge from the hospital of an infected~     wound that requires admission. Each arm of this study represents the two commonly practiced~     standard of care treatment plans for patients presenting with infected wounds. It is~     currently unknown which SoC option provides the best patient outcome.~   "
38016|NCT02559440|"~     The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid~     hypertrophy children with severe allergic rhinitis.~   "
38017|NCT02559427|"~     The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea~     in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea~     Syndrome (OSAS).~   "
38018|NCT02559414|"~     The proposed study will add to the growing understanding of platelet activity and platelet~     inhibition in subjects with HIV. It will examine the relationship between platelet activity~     and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy)~     in this high-risk cohort. Furthermore, it will provide important data on the mechanism of~     platelet activity and its inhibition using biomarkers of platelet activity, inflammation,~     immune activity and endothelial function and genetic expression profiling.~   "
38019|NCT02559401|"~     Currently, standard-of-care tractography is based on information obtained from diffusion~     tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is~     routinely obtained on neurosurgical patients to assist in pre-operative planning. The~     primary objective of the proposed study is to determine the ability of msHARDI-based~     tractography to discern fibers in edematous brain regions.~   "
38020|NCT02559388|"~     In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic~     pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily~     activity disorders enroll in this study. These patients should have at least a course of~     therapy without proper response. After proper informing patients and taking testimonial~     patients enter to study. Then patients randomized in case and control group. In case group,~     patients took montelukast 10 milligram daily and in control group took placebo for 30 days.~     Other antipruritic or antiinflammatory medication has been stopped one week prior to~     starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP),~     Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of~     study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and~     Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score~     and its severity added to crude score at beginning and end of study and change of measures~     analyzed.~   "
38021|NCT02559375|"~     This study will increase knowledge of patient preferences for pain treatments, and improve~     the ability to meet patients pain management needs. This study will assess patient attitudes~     towards underutilized treatments and identify technologies to increase awareness of such~     treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in~     future clinical and cancer control research and better understand how to effectively raise~     patients awareness of supportive cancer services.~   "
38022|NCT02559362|"~     The goal of the study is to establish the feasibility/willingness of breast cancer patients~     to delay surgery to do an exercise program, or be randomized to an exercise training program~     following treatment, and to see if that willingness correlates with prior physical activity~     history.~   "
38023|NCT02559349|"~     A pilot, single arm, single center study to determine the feasibility of obtaining stool~     samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the~     gut microbiota and to obtain preliminary data about possible correlation of baseline~     composition and changes in gut microbiota with tumor response, local control, and~     development of pneumonitis/other side effects.~   "
38024|NCT02559336|"~     Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital~     admissions. Palliative care has been shown to improve patient outcomes such as quality of~     life and symptom burden. Our long-term aim is to study the effect of Supportive and~     Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute~     hospital inpatient setting. To this end, we propose a pilot study that will provide the~     necessary information for the planning of a subsequent larger scale Phase III trial of~     SPaRK.~      The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability~     of advanced cancer patients to complete the Functional Assessment of Cancer Therapy -~     General (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the~     four domains of physical well-being, social/family well-being, emotional well-being, and~     functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK~     model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to~     change of FACT-G over 3 days and 4) to explore views of healthcare professionals and~     stakeholders on SPaRK as a model of integrated palliative care and oncology care service~     delivery.~      In the short term, the results from this study will be used to plan a larger scale Phase III~     study of SPaRK. In the long term, a resource-efficient and effective model of care needs to~     be developed for the aging population and rising palliative care needs of patients. If~     successful, this pilot study will lead on to the testing of SPaRK, which does not rely~     wholly on specialist palliative care manpower, but involves both specialists and~     non-specialists working together to provide palliative care, and hence can be feasibly~     scaled up across institutions and extended to non-cancer patients.~   "
38025|NCT02559323|"~     Cancer survivors face unique health challenges as a result of their cancer diagnosis and~     treatment. OncoLink created an Internet based program for survivors to learn about their~     risks. A follow up survey will allow us to continue to develop the program in ways that will~     benefit users. This survey will need to be conducted via email, which will require the~     collection of the users email address and a secure method of linking the users care plan~     questionnaire answers to their survey answers.~   "
38026|NCT02559310|"~     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the~     treatment of adults with moderate to severe community-acquired bacterial pneumonia.~   "
38027|NCT02559297|"~     This prospective interventional study aims to compare sevoflurane and desflurane anesthetic~     agents on regulatory T cell (Treg) numbers and its cytokine production in patients~     undergoing Living Donor Kidney Transplant (LDKT).~   "
38028|NCT02559284|"~     The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution~     and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER®~     NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at~     14 days post-surgery.~   "
38029|NCT02559271|"~     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in~     a pediatric population (between 5 and 16 years of age).~   "
38030|NCT02559258|"~     This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose-~     escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and~     female subjects. There will be five dosing cohorts (0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg), with~     eight subjects in each cohort, randomized to either epsi-gam (6 subjects) or placebo (2~     subjects) for a total of 40 subjects. The first cohort will receive the starting dose of 0.1~     mg/kg epsi-gam or placebo and subsequent cohorts will be recruited sequentially to receive~     escalating doses of epsi-gam or placebo.~   "
38031|NCT02559245|"~     This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel~     syndrome predominant constipation. Half of patients receive Ficus carica while others~     receive Descurainia Sophia for 4 weeks.~   "
38032|NCT02559232|"~     This is a retrospective observational study to describe the sociodemographic and clinical~     characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk~     of stroke or systemic embolism, who at least three months ago changed their anticoagulant~     therapy, due to any clinical situation, and are currently on treatment with a direct oral~     anticoagulant (DOAC)~   "
38033|NCT02559219|"~     Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and~     Patient Satisfaction is a pilot project designed to test the feasibility and acceptability~     of use of an online care plan generator for adult survivors of pediatric cancers.~      Because of improvements in cancer screening, diagnosis and treatment, there are an estimated~     13 million cancer survivors living in the U.S. today, with projected growth to 18 million by~     2020 (De Moor). These survivors include survivors of leukemia and lymphoma, as well as solid~     tumors including breast, colon, testicular and prostate cancers. It also include a subset of~     patients who are survivors of pediatric cancers, as over 80% of children diagnosed with~     cancer today are cured. In fact, it is estimated that 1 in every 600 young adults between~     the ages of 20-35 is a cancer survivor (Dreyer, Hewitt, Greenlee).~      Cancer patients as a whole, despite improved cure rates, have been shown to receive~     inadequate medical care as survivors. Comprehensive survivorship care should include routine~     age appropriate medical care as well as information about prior diagnosis and treatment, and~     screening for recurrence of their primary malignancy as well as secondary malignancies, and~     screening for late effects of cancer treatment (Earle, Craig). Adult survivors of pediatric~     cancer, exposed to life-saving but toxic treatments during times of growth and development,~     are particularly prone to late effects but also have been shown to have inadequate~     monitoring and follow up. This is a concern as late effects of treatment are sometimes~     silent for years or decades after completion of cancer therapy and that adult survivors of~     childhood cancer, years from their diagnosis and treatment, have been shown to have alarming~     rates of life threatening chronic health conditions compared to their peers (Oeffinger).~     Thus, these late effects may emerge during adulthood when patients have moved on from the~     care of their primary oncologist. Complicating matters, primary care providers, who often~     assume the care of these patients, may not have the knowledge or tools necessary to~     appropriately care for survivors of childhood cancer (Suh).~      National organizations have come together to identify ways to improve quality of and access~     to long term follow up care for adult survivors of childhood cancer. The Children's Oncology~     Group published Long Term Follow up guidelines which recommend lifelong risk based follow up~     care and screening (COG guidelines). In addition, in 2005, the Institute of Medicine~     published a report, From Cancer Patient to Cancer Survivor: Lost in Transition gave~     recommendations to improve health outcomes of cancer survivors which includes the receipt of~     a comprehensive care summary and follow up plan to aid in appropriate risk based follow up~     care (Hewitt). Despite these recommendations childhood cancer survivors knowledge about past~     diagnosis and treatment and engagement in follow up care is suboptimal (Kaden-Lottick,~     Nathan). It has been demonstrated that pediatric cancer survivors are not receiving care~     summaries, and thus may try to find appropriate follow up information via the other sources~     such as the internet (Casillas).~      Oncolife, a free online tool to create survivorship care plans, was created in May 2007~     (Hill 2009), and has been housed at maintained at the University of Pennsylvania since then.~     This tool has shown to be feasible way to provide information and care plans to survivors of~     adult cancers. In addition, survivors who have used the resource, state that it will, or has~     already, positively influenced communication about cancer related follow up with their~     healthcare team (Hill 2013).~      The study aim is to adapt Oncolife to provide individualized information for adult survivors~     of childhood cancer with the unique recommendations for long term follow up for pediatric~     cancer survivors. Oncolife has already been collecting data on plans created by adult~     survivors of adult cancers and has been reviewed by the IRB previously (IRB#806368 and~     #811528 note: previously called Oncolink). Adaption of Oncolife to meet the needs of adult~     survivors of childhood cancer will improve access to high quality electronic health~     information as patients may find long term follow up guidelines cumbersome or largely~     irrelevant to their needs depending on their specific exposures. Individualizing the~     available information to a particular survivor will allow for better understanding of and~     improved adherence to recommended cancer related follow up care. We propose to develop~     survivorship care plans in a way that will most benefit users, thus after creation of the~     Smart Adult Living After Childhood Cancer care plan we will ask for patient input via survey~     immediately after receipt of their care plan and in a one month follow up survey.~   "
38034|NCT02559206|"~     The objectives of this study are to evaluate the safety, efficacy, and dose response of two~     delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2~     is DR2) administered orally to patients with irritable bowel syndrome with constipation~     (IBS-C). Additional objectives include understanding how the two DR formulations compare~     with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR]~     formulation of linaclotide).~   "
38035|NCT02559193|"~     The Study is a single-arm prospective trial of patients receiving at least one medication~     with a known association between genetics and drug metabolism. All patients will undergo~     genetic testing as determined by their treating physician. The specific genes tested will,~     in general, be based upon the drugs the patients are taking or those that the patient's~     treating physician is considering as potential substitutes for current medications.~   "
38036|NCT02559180|"~     Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously~     treated with intravitreal anti-Vegf agents (ranibizumab or bevacizumab)~   "
38090|NCT02558478|"~     Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in~     very rare diseases for which the previous genetic explorations remain negative to date. The~     aim of this project is based on groups of patients with original clinical phenotypes~     including neurosensory impairment without genetic cause identified to date. The~     investigators will study these families using whole exome sequencing to potentially identify~     new genes and new underlying biological pathways involved in neurosensory diseases.~   "
38037|NCT02559167|"~     In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on~     cocaine craving and relapse. Cocaine addiction is characterized by compulsive substance use~     and repetitive urges to consume the drug even after a sustained period of abstinence. While~     substance use remains the most obvious direct outcome of addiction, there is a growing~     interest in other core symptoms of this disorder. Craving has become a subject of great~     interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing~     symptom of addiction associated with suffering. Indeed, even after a period of abstinence,~     cocaine-dependent individuals remain vulnerable to stress and other craving-inducing~     stimuli, which, in turn, lead to intense physiological responses and various negative~     feelings such as anger and sadness. Real-time daily monitoring of craving and drug use has~     shown that craving predicts cocaine relapse among cocaine-dependent individuals. In sum,~     working toward improving the treatment of craving could not only help prevent relapse, but~     also reduce patient distress on emotional, cognitive, and physiological levels. In the past~     decades, significant scientific efforts have been deployed toward the development of~     innovative strategies to beat cocaine addiction, but with partial success thus far.~     Psychosocial approaches have been widely used to help cocaine-dependent patients achieve~     better outcomes after drug cessation, but literature indicates that these strategies alone~     are at times insufficient to induce significant behavioural changes or a reduction in rates~     of drug consumption. Unlike other types of addiction, such as opioid and alcohol, no~     pharmacological treatment has yet been found to be truly effective in relieving~     cocaine-cessation symptoms like craving and anxiety or to prevent relapse. CBD is a natural~     cannabinoid with a favourable tolerability profile and discrete neurobiological actions that~     are linked to neural circuits closely involved in addiction disorders. Addiction to cocaine~     is characterized by alternating phases of intoxication and short abstinence, followed by~     recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that~     CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological~     contender to decrease cocaine craving and treat cocaine addiction. Previous studies~     conducted in animals and humans confirm that CBD is a very safe and tolerable medication.~   "
38038|NCT02559154|"~     To investigate the efficacy of a modified bortezomib based combination therapy for patients~     with multiple myeloma.~   "
38039|NCT02559141|"~     The Nexfin monitoring system offers a complete non-invasive approach to a continuously~     estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour~     analysis. Several clinical investigations have proven reliability and interchangeability of~     the Nexfin technology yielding acceptable results especially regarding the trending~     abilities. At present there is no evidence available, whether a early goal directed~     hemodynamic optimization protocol based on a completely non-invasive monitoring technology~     is able to reduce postoperative complication. Therefore, the aim of this single-center study~     is to compare the clinical outcome and postoperative complications of patients undergoing~     major colorectal surgery treated with standard of care or with a GDT protocol based on the~     Nexfin technology.~   "
38040|NCT02559128|"~     The purpose of this cross-sectional comparative 2x2 trial study is to compare the degree of~     insulin resistance, myocardial function and selected metabolic parameters and to explore the~     pathophysiological mechanisms by which insulin resistance is implicated in development of~     chronic heart failure (HF) in patients with type 2 diabetes and prediabetes (T2D).~      Investigators hypothesize that patients with heart failure will be insulin-resistant and~     will display metabolic abnormalities as patients with diabetes.~   "
38041|NCT02559115|"~     The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can~     show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled~     DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study~     is being done because there are unmet medical needs to improve the current ways of detecting~     prostate cancers before surgery.~   "
38042|NCT02559102|"~     This is a prospective randomized controlled trial comparing dexmedetomidine sedation with~     caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal~     herniotomies in neonates and infants below 3 months of age.~      The investigators will compare the efficacy and adverse events associated with each of these~     techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2~     years of age.~   "
38043|NCT02559089|"~     Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune~     encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed~     as other causes of encephalitis. Therefore, it is urgent to establish a database of~     anti-NMDA receptor encephalitis in Chinese population. The multi-center, prospective~     clinical trial of anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu~     hospital, Beijing Tiantan Hospital, Beijing Children's Hospital and other hospitals around~     the country, by screening the NMDA receptor antibody and summarizing the cases analysis, in~     order to provide evidence for clinical diagnosis and treatment of anti-NMDA receptor~     encephalitis.~   "
38044|NCT02559076|"~     The aim of the present study was to investigate the potential factors that determine~     preschool obesity in Al Ain, United Arab Emirates, and assess the effectiveness of a simple~     healthy lifestyle tool: Eat Right Emirates (ERE) adapted from the Ten Steps for Healthy~     Toddlers, produced in the UK by the Infant and Toddler Forum.~   "
38045|NCT02559063|"~     This project seeks to identify neural changes that occur in adults with mild cognitive~     impairment (MCI) after engagement in computerized cognitive training. In addition, this~     project aims to identify physiological factors that may bolster effects of the training on~     cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD).~     Understanding how cognitive training protects cognitive function in MCI can contribute to~     development of effective interventions to slow progression to AD in individuals at risk,~     thereby reducing the significant morbidity and health care costs associated with AD.~   "
38046|NCT02559050|"~     A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction~     and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity~     constriction.~   "
38047|NCT02559037|"~     The purpose of this study is to observe the efficacy and safety of acupuncture and~     moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and~     mucosal immunity.~   "
38048|NCT02559024|"~     This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the~     immune cell environment within colorectal cancer metastases. The drug will be administered~     to patients before surgical treatment.~   "
38091|NCT02558465|"~     The objective of this investigation is to assess safety and effectiveness of Xarelto under~     practice routine use in VTE secondary prevention after acute DVT, focusing on~     hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality.~     This study is a company sponsored, one- arm prospective cohort study with patients to whom~     Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard~     observation period (1 year) and an extension survey period (2 years, at the longest).~   "
47702|NCT02432677|"~     The purpose of this study is to evaluate the potential additive effect of tDCS compared to~     placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in~     healthy volunteers .~   "
38049|NCT02559011|"~     Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive~     treatment option in patients with symptomatic severe aortic valve (AV) stenosis at~     prohibitive or increased risk for conventional open-heart surgery. Recent randomized~     clinical trials reported a large treatment effect of TAVI over medical treatment among~     inoperable patients and similar or superior outcomes compared with surgical aortic valve~     replacement in high to intermediate risk patients. However, atrio-ventricular conduction~     disturbances and arrhythmias (in particular atrial fibrillation) before, during or after~     TAVI remain a matter of concern as they have important consequences.~      The objective of this study is to investigate the incidence, nature and prognostic~     significance of AV-conduction disturbances and arrhythmias among patients with severe,~     symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a~     small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM).~      One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at~     the time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted~     under the skin of the chest under local anesthesia. The device will be interrogated just~     prior to readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The~     incidence of symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and~     its impact on medical and device treatment as well as clinical outcomes analyzed.~      The present study will provide information about the actual incidence and impact of~     symptomatic and silent arrhythmias and AV-conduction disturbances among patients with~     severe, symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the~     burden of arrhythmias before TAVI and to accurately determine the incidence of new onset~     atrial fibrillation and complete AV-block within 12 months after the procedure. Identifying~     patients at risk for AV- conduction abnormalities, atrial fibrillation (AF), and~     non-sustained or sustained ventricular arrhythmias may guide future preventive measures,~     medical treatment and improve patients outcomes after TAVI.~   "
38050|NCT02558998|"~     The objective of this study is to 1) evaluate the impact of a novel individualized care~     planning/ educational technology (the On Q Care Planning System or CPS) on oncology patient~     and provider knowledge, attitudes and beliefs about Non-Small Cell Lung Carcinoma (NSCLC)~     clinical trials, as well as 2) to evaluate the impact of the On Q CPS on patient referral to~     and enrollment in NSCLC clinical trials.~   "
38051|NCT02558985|"~     No interventions outside the normal course of patient care. The investigators will be~     collecting data at specified points throughout the casting process.~      The proposed study will measure lung compliance during the casting process for spinal~     manipulation. Research questions include: Is there a quantifiable change in lung compliance~     during the casting process? Is there an individual change in lung compliance over time~     comparing collection points at each cast change? Is there a change in appearance of~     flow-volume loop? Is there a decrease in oxygen saturation from post-induction baseline? The~     investigators hypothesize that there is a change in lung compliance and a decrease in oxygen~     saturation during the casting process.~   "
38052|NCT02558972|"~     Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of~     consciousness and represents the acute episodic form of orthostatic intolerance (OI).~     Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by~     debilitating symptoms and signs while upright relieved by recumbency. Northera should~     therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic~     splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the~     orthostatic response in POTS and VVS.~   "
38053|NCT02558959|"~     This study is designed to investigate the effect of second-line irinotecan and capecitabine~     versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract~     cancer patients.~   "
38054|NCT02558946|"~     The purpose of this study is to determine if pelvic floor muscle training with a physical~     therapist before and after surgery will improve health-related quality of life following~     robot-assisted radical prostatectomy.~   "
38055|NCT02558933|"~     The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful~     in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool~     for cognitive and health related quality of life improvement in Down's syndrome.~      The objective is to determine the efficacy of EGCG as a therapeutic candidate for the~     improvement of cognitive performance in FAS patients.~      Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy~     of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An~     oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6~     months after finishing the treatment.~   "
38056|NCT02558920|"~     Sugars have been implicated in the epidemics of overweight and obesity. This view is~     supported by lower quality evidence from ecological observations, animal models, and select~     human trials. Higher level evidence from controlled trials and prospective cohort studies~     has been inconclusive. Whether sugars contribute to weight gain or increases in adiposity~     independent of their calories and whether important food sources other than SSBs are~     associated with a higher risk of overweight and obesity remain unclear. To address the~     uncertainties, the investigators propose to conduct a series of systematic reviews and~     meta-analyses of the totality of the evidence from controlled trials and prospective cohort~     studies to distinguish the contribution of fructose-containing sugars and important food~     sources of added sugars (SSBs, pure fruit juice, cakes/sweets, yogurt, cereals, etc) from~     that of energy in the development of overweight and obesity. The findings generated by this~     proposed knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers~     and patients, stimulating industry innovation, and guiding future research design~   "
38057|NCT02558907|"~     Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal~     Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer~     will be received an examination oncogériatric~   "
38058|NCT02558894|"~     A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in~     Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.~   "
38059|NCT02558881|"~     France is among the countries with a high incidence of colorectal cancer. The prognosis~     associated with colorectal cancer is related to the development stage of the disease at~     diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival~     rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France~     since the end of 2008.~      This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and~     if positive 2) the realization of an optical colonoscopy examination currently regarded as~     the evaluation procedure colon reference. But as part of this organized screening, 13% of~     those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the~     refusal, virtual colonoscopy may be proposed as an alternative according to the~     recommendations of the National Health Authority in 2010. But it has never been assessed as~     part of organized screening. Similarly another alternative is recently developed colic~     capsule that benefits of development in recent years of the capsule for the small intestine~     which has become the gold standard for diagnosis of most diseases of the small intestine~     (bleeding occult, diagnosis of unknown colitis...).~      Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive~     FOBT as part of organized screening and did not realize optical colonoscopy after the usual~     procedure and complete recovery. This study aims to answer the question of the place of~     colic capsule as part of organized screening. An economic component is integrated to assess,~     in terms of health insurance, the cost associated with these two exams, and compare them to~     the cost of optical colonoscopy.~      The proposed study is an observational study of impact of an alternative screening strategy~     for colorectal cancer whose primary objective is to compare the rate of acceptance of~     virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.~   "
38062|NCT02558842|"~     Brazil ranks 17th among the 22 countries responsible for 80% of tuberculosis (TB) cases in~     the world. In 2010, the number of new cases of tuberculosis in Brazil was 71,930 and in 4972~     RS. In 2010, Brazil had a disease incidence of 37.6 / 100,000 in 2011 fell to 36.0 /~     100,000. The Rio Grande do Sul(RS)S showed an incidence rate of 46.1 / 100,000 in 2011. The~     mortality rate was 2.4 / 100,000 population per year in Brazil and RS.~      In Porto Alegre, the incidence rate of all clinical forms of tuberculosis has remained, in~     the last six years, around 100/100.000 inhabitants per year, while the coefficient of~     pulmonary tuberculosis remained on average 50/100.000 inhabitants to year. Thus, Porto~     Alegre holds the 2nd place in Brazil among the capitals with the highest incidence of TB,~     classifying the city as high risk 5th. Porto Alegre also has a co-infection TB / HIV from~     35.3% one of the highest in the country.~      The best strategy to prevent new cases of tuberculosis is to invest in early diagnosis and~     effective treatment of existing cases of the disease. As the treatment of the disease~     requires daily use of medications for an extended period of time (at least 6 months),~     adherence becomes the main determinant of the rate of healing of disease.~      There are several factors that contribute to poor adherence and treatment dropout:~     alcoholism, illicit drug use, infection with human immunodeficiency virus (HIV Human~     Immunodeficiency Virus), low education, unemployment, poor housing and prolonged the~     treatment. The irregular treatment and neglect are the major obstacles to the control and~     elimination of this disease.~      Study in Porto Alegre pointed alcoholism, TB / HIV, the fact that the patient does not~     reside with family and low education as predictors of dropout. The dropout rate in the~     general population of patients with active tuberculosis was 10.7% (8.0% - 17.0%).~     Abandonment occurred more often within the first three meses8.~      In Porto Alegre, 32.5% of new TB cases are diagnosed in hospitals. Twenty percent of these~     patients do not bind, after discharge, the Tuberculosis Control Program (TCP), ie, the~     patient egress from the hospital does not reach the basic health unit (BHU) reference for~     further monitoring and treatment, which is considered a serious flaw in the process control~     of the disease.~   "
38063|NCT02558829|"~     The Macimorelin-GHST (growth hormone stimulation test) will be compared with the ITT~     (insulin tolerance test) in an open-label, randomized, 2-way crossover Trial. The trial will~     include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of~     healthy control subjects.~   "
38064|NCT02558816|"~     This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.~      The study will be conducted into 2 steps. The first one will be to ensure the safety of the~     combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses.~      A total of 9 patients will be included in this first step (step A) with grouped inclusions~     of three patients (a safety evaluation will be performed at each inclusion of 3 patients).~      The second step (step B) will be conducted if no unacceptable toxicity is observed during~     the first step and 24 new patients will be included in the step B. The aim of the second~     step is to determine the MTD of the GDC-0199 in combination of GA101 and Ibrutinib (both~     respecting the previous doses) by using a Continual Reassessment Method.~   "
38065|NCT02558803|"~     Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care~     provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses~     of HPV vaccine for eligible male and female adolescents who have initiated vaccination.~   "
38066|NCT02558790|"~     This study is a 12-week, open-label pilot study to test the effects of MMFS-201-301 on~     cognition and function in adults with ADHD. Subjects may enter the trial on a stable dose of~     medication for ADHD, and MMFS-201-301 will be given. Subjects who do not enter on a stable~     dose of ADHD medication will receive MMFS-201-301 alone.~   "
38067|NCT02558777|"~     Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial~     (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and~     severity of delirium in hospitalized older adults in an AGU.~      Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU~     Complejo Hospitalario Universitario from Albacete (Albacete, Spain).~      Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29~     control group).~      Interventions: After risk factor analysis, all participants in the intervention group (IG)~     received a daily multicomponent intervention (orientation, sensorial deficit, sleep,~     mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the~     intervention nurses. The control group (CG) received usual care.~      Measurements: Delirium presence was determined daily with the Confusion Assessment Method~     (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality,~     days of hospitalization, use of physical restraint measures, and use of drugs for delirium~     control (neuroleptics and benzodiacepines) were also recorded.~   "
38068|NCT02558764|"~     Advances in surgical techniques and immunosuppression (IS) have led to an appreciable~     reduction in postoperative complications following kidney transplantation. However, surgical~     site events (SSE) including surgical site infections (SSI) and other wound complications are~     still very common and they can limit these improved outcomes and result in prolonged~     hospitalization, hospital readmission and reoperation, consequently increasing overall~     transplant cost.~      Negative pressure wound therapy (NPWT) is a concept introduced initially to assist in the~     treatment of chronic open wounds. This technique uses a negative pressure unit and specific~     dressings that help to hold the incision edges together, redistribute lateral tension,~     reduce edema, stimulate perfusion and protect the surgical site from external infectious~     sources. Thus, it provides faster wound healing and shortens hospital stay.~      Recently, there has been growing interest in using portable NPWT devices on closed incisions~     after surgery to prevent potential SSI and other wound complications in high-risk patients.~     Investigations regarding this technique in various surgical settings have shown that it can~     reduce the risk of SSI and other wound complications. These studies concluded that any~     patient undergoing transplantation should be considered as 'high-risk' and should receive~     this treatment.~      To date, no studies are reported in literature exploring the effects of preventive use of~     portable NPWT devices on surgical wounds in the setting of organ transplantation. The aim of~     our study is to compare a portable NPWT device (PICO, Smith & Nephew, London UK) to~     conventional gauze dressings in patients undergoing kidney transplantation (KT) surgery.~   "
38092|NCT02558452|"~     SENIOR transplant Registry European transplant registry of senior renal transplant~     recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus~     once daily, mycophenolate and steroids to investigate long term outcomes on an observational~     basis.~   "
38093|NCT02558439|"~     The purpose of this study is to evaluate the safety and efficacy of a single injection of~     CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.~   "
38154|NCT02557646|"~     The purpose of this open-label, non-randomized, single-arm, multicentre observational study~     is to investigate the influence of the cumulative dose (total administered dose/ planned~     dose) of ribavirin on the sustained virologic response (SVR) in participants who have been~     receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin~     (Copegus).~   "
38069|NCT02558751|"~     The investigators hypothesized that vaccination with either the 23-valent pneumococcal~     polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV~     13) followed by PPV23 results in similar antibody levels/functional activity and induce a~     similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive~     individuals >50 years of age and HIV-negative persons>50 years of age. The investigators~     immunized the study group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13~     followed by PPV23 and HIV+>50 with PPV23 alone. The investigators examined immune responses~     to PPS23F and PPS14 on a quantitative and qualitative level using ELISA and opsonophagocytic~     assays (OPA).~      To test the hypothesis that the levels of antigen specific B cells identified with PPS were~     comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization~     peripheral blood samples were obtained. Extensive B cell phenotype analysis using~     fluorescent antibodies was used to characterize PPS-labeled B cells. Specific phenotypes~     were correlated with antibody levels and OPA and compared to historic populations immunized~     with PPV.~   "
38070|NCT02558738|"~     In this observational study, insights regarding the tolerability and influence on the~     quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear~     spray shall be gained under real life conditions in patients with chronic eczematous~     irritations and pruritus of the outer ear canal.~   "
38071|NCT02558725|"~     Since normal pregnancies are associated with dilutional anemia, due to a greater increase in~     plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA~     according to the levels of serum ferritin. Previous studies examining the optimal iron dose~     have shown that adjustment of iron supplementation according to serum ferritin levels in~     early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the~     appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum~     ferritin levels.~      In this trial the investigators sought to assess the efficacy of doubling the daily iron~     supplement dose in pregnant women with IDA.~   "
38072|NCT02558712|"~     The purpose of this study is to compare the Technology-based Eye Care Services (TECS)~     protocol to the standard face to face ophthalmologic exam.~   "
38073|NCT02558699|"~     Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal~     atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, we~     propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial~     computer model. We will conduct virtual rotor mapping in the patient specific atrial model.~     Then, we will compare the clinical outcome of conventional circumferential pulmonary vein~     isolation and additional rotor ablation guided by virtual rotor mapping.~   "
38074|NCT02558686|"~     Application of trigger point dry needling can induce post-dry needling soreness. This is not~     a negative experience, but sometimes some patients want to reduce it as much as possible.~     Manual therapies and exercise strategies targeting to decrease post-dry needling soreness~     need to be investigated.~   "
38075|NCT02558673|"~     The purpose of this study was to understand the production of trimethylamine-N-oxide (TMAO)~     and its metabolites from dietary precursors found in fish, eggs and beef. In addition, this~     study traced the fate of supplemental TMAO that has been labeled with deuterium to determine~     how TMAO is being used in the body.~   "
38076|NCT02558660|"~     The purpose of this study is to evaluate the impact of a brief clinic-based educational~     intervention on utilization of Double Up Food Bucks (DUFB)—a Michigan-wide Supplemental~     Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center~     patients at a community health center in Southeast Michigan.~   "
38077|NCT02558647|"~     This first aim of this study is to evaluate the effect of a cost-effective, more accessible~     alternative treatment approach for insomniacs. Traditional CBT-I has been adapted to an~     online intervention system, so individuals can access a personalized treatment when they~     want. This newly developed web-based computer technology has produced remarkable preliminary~     results, comparable to the results one can achieve when delivering CBT-I in a face-to-face~     format. The current project will test this approach for use on a population scale. Of the 13~     500 participants reporting symptoms of insomnia in HUNT3, 1500 will be randomized into CBT-I~     or a placebo control group. The large scale of this trial will allow detailed analyses of~     subgroups (insomniacs with comorbid conditions), which has not been possible in the previous~     small clinical trials. The upcoming HUNT4 in 2017-2018 will together with data from FD-Trygd~     provide unique long-term FU-data on both a range of health parameters and employment status.~     The second aim is to use the HUNT3 Biobank to examine how genes may be related to insomnia.~     Our study will also be the first of its kind to examine if genes may predict the outcome for~     individuals in the treatment study.~   "
38078|NCT02558634|"~     Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological~     voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles.~     Current treatments such as botox and voice therapy only provide temporary relief and thus,~     the investigators are exploring new strategies to provide long-term, sustained improvement.~      Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of~     electrodes to deliver electrical stimuli to specific brain regions. It is the standard~     surgical treatment for many other movement disorders such as Parkinson's disease, essential~     tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS~     can improve the vocal dysfunction of LD.~   "
38079|NCT02558621|"~     The main objectives of the study are to evaluate the acceptance into operating flow,~     performance and safety of the AQrate Robotic Assisted System during the spinal fusion~     surgery~   "
38080|NCT02558608|"~     This subject analysis of the influence of the dissociating inferior pulmonary ligament on~     pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by~     video assisted thoracic surgery. All patients are randomly divided into two groups: group A~     and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect~     the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior~     pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed~     between the two groups.~   "
38081|NCT02558595|"~     The purpose of this study is to observe the effects of niacinamide on markers of kidney~     injury, inflammation, kidney cyst growth and kidney function.~   "
38082|NCT02558582|"~     Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left~     untreated. Advances in medical therapy have improved survival according to recent registries~     and systematic reviews, but are associated with high healthcare costs.~      Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise~     training on improving exercise performance, quality of life and pulmonary hemodynamics in~     patients with pulmonary hypertension.~      The main objectives of the present project are:~        1. to investigate the quality of the implementation of a standardized 3 week in-hospital~          exercise training program on markers of outcome and disease severity in PH-patients in~          Switzerland immediately after training and after 3 and 12 month.~        2. to look whether training with hyperoxia vs. standard care might be more effective.~      This is a multicentre, randomized parallel-group trial where the intervention rehabilitation~     is delayed in one group so that they can serve as standard care controls for the others.~      In a nested single-centre randomized-controlled trial patent will additionally be randomized~     to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental~     oxygen therapy (SSOT) during nights and ergometer training.~      Patients will receive a PH specific rehabilitation program during 3 weeks followed by an~     instructed home-based training program for 12 weeks. Patients who are not already under~     long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to~     receive standardized supplemental oxygen therapy (SSOT) during training and nights upon~     written informed consent.~   "
38083|NCT02558569|"~     This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor~     patients. The control group will receive standard general anesthesia with the use of~     fentanyl for intraoperative pain control and the study group will receive scalp nerve block~     with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain~     control. The scalp nerve block might reduce the dose of fentanyl and promote faster~     emergence from general anesthesia.~   "
38084|NCT02558556|"~     Rationale: Several clinical feasibility studies have shown the potential benefit of~     near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) for enhanced and~     earlier biliary anatomy visualization during laparoscopic cholecystectomy with the aim to~     reduce the number of vascular and biliary injuries. Although the incidence of injuries is~     low (0.7%), the impact on patients in terms of morbidity, quality of life and costs are~     dramatic. The Critical View of Safety (CVS) technique is regarded as the safety valve in~     conventional laparoscopic cholecystectomy (CLC). It is hypothesized that standard~     application of near-infrared fluorescence imaging during laparoscopic cholecystectomy can be~     useful to obtain establishment of CVS (at least 5 minutes) earlier and with more certainty~     regarding visualization when compared to conventional laparoscopic imaging alone.~      Study design: A multicenter randomized controlled trial with two study arms. Patients~     scheduled for an elective laparoscopic cholecystectomy will be recruited and randomized at~     the outpatient clinic (n = 308 total). One group will undergo near-infrared fluorescence~     cholangiography assisted laparoscopic cholecystectomy (NIRF-LC) and the other group will~     undergo conventional laparoscopic cholecystectomy (CLC).~      Compared with standard care, patients in the NIRF-LC group have to receive one preoperative~     intravenous injection of ICG. This is the only additional minimally invasive action for the~     patient. Initially, patients participating in this study will not benefit from the~     application of NIRFC during the surgical procedure. The administration of ICG and the~     modified laparoscope itself are not related with any kind of additional risk for the~     patient.~      Despite the encouraging results from several (pre)clinical feasibility studies, wide~     clinical acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due~     to the absence of reliable and validated clinical data. A randomized clinical study is~     desirable to assess the potential added value of the NIRF imaging technique during~     laparoscopic cholecystectomy. Strong evidence in favor of routine implementation of this new~     imaging technique during laparoscopic cholecystectomy, will probably lead to worldwide~     routine application of the NIRF technique. Therewith long term sustainability of this~     research project is guaranteed.~   "
38085|NCT02558543|"~     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an~     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are~     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis.~      . The injection of adipose autologous tissue is a common practice in plastic surgery, and~     has been known for over a century. Adipose tissue, originally used to increase volume, is~     also characterized by trophic properties associated to stromal vascular fraction (SVF),~     which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF~     cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.~      A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed~     the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of~     twelve patients to be proven.~      The encouraging results have encouraged us to propose a trial which would bear on a higher~     number of patients and include a control group.~   "
38086|NCT02558530|"~     The major adverse health consequences of obesity occur only when non-alcoholic fatty liver~     disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of~     triglycerides and other lipids. The first-line approach to NAFLD management is caloric~     restriction and weight loss, but these remain difficult to achieve. Little attention has~     been given to dietary carbohydrate restriction, despite recent reports showing that hepatic~     de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the~     postprandial state, accounts for approximately 25% of liver triglyceride content in~     hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides~     were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized~     30% fat diet for four days before being assessed.~   "
38087|NCT02558517|"~     Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The~     aim of this study was to study the possibility of corticosteroids interruption in patients~     with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.~   "
38088|NCT02558504|"~     First intent treatment for superficial circular esophageal neoplasm is surgical resection.~     Endoscopic mucosal resection is not recommended due to the high rate of subsequent~     esophageal stenosis (higher than 80%).~      Surgical limits are related to a high level of morbidity due, in particular, to respiratory~     complications or infections that require prolonged hospitalisations, and by significant rate~     of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative~     technique to remove esophageal circular preneoplastic and neoplastic lesions has been~     developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which~     incorporates approximately 100 electrodes on its surface that emit radiofrequency waves~     (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration~     of the electrical impulses, it is possible to obtain a homogenous and controlled destruction~     of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic~     elements underneath. The technique will be used for high grade glandular epithelial~     neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus,~     occupying more than half of the circumference of the esophagus and that requires surgical~     treatment. The expected benefit for the patient is linked to the reduced invasiveness of the~     technique in comparison to the surgery~   "
38094|NCT02558426|"~     Chronic Venous Disease (CVD) is a very common problem affecting western adult population. To~     date the pathophysiology of CVD development encloses several theories such as the role of~     extracellular matrix (ECM) components alterations, the alteration of Matrix~     Metalloproteinases (MMPs) and other related molecules, the endothelial dysfunction, and~     several genetic factors but none of these could properly explain its genesis. Estrogen~     Receptors may be involved in CDV pathogenesis. Endogenous estrogens are important regulators~     of vascular homeostasis and they act mainly via three different ERs which are expressed in~     the cardiovascular system: ERα, ERβ, and a G protein-coupled estrogen receptor termed GPER.~     of this study is to explore the expression of estrogen receptors in vessel wall of varicose~     veins through the entire clinical spectrum of CVD.~   "
38095|NCT02558413|"~     This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1~     clinical trial to determine the safety and tolerability of BTA-C585 administered orally to~     healthy subjects.~   "
38096|NCT02558400|"~     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to~     Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.~      Following completion of the Month 12 study visit procedures, subjects will be offered the~     opportunity to participate in a 2-month observational (i.e., non-interventional) trial~     extension.~   "
38097|NCT02558387|"~     Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in~     patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR~     might be important role in salivary gland cancers. Accordingly, several trials with various~     anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in~     salivary gland cancer are ongoing.~      Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor~     (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in~     initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the~     target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo~     nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg,~     leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts~     of a broad range of differing human tumors.~      Based on this background, in this study, the investigators would like to conduct a phase II~     study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland~     cancer of the head and neck to evaluate efficacy and safety.~   "
38098|NCT02558374|"~     To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic~     Solution compared to Timolol Maleate Ophthalmic Solution.~   "
38099|NCT02558361|"~     Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic~     arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works~     in the laboratory, there are very few demonstrating how it works in the actual target organ,~     i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.~      Laboratory data has demonstrated that apremilast decreases inflammatory proteins and~     increases anti-inflammatory proteins. However, almost all of these data/studies have been~     performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or~     synovial (joint) tissue. These studies that have been performed on the blood of patients~     with this condition may, or may not, reflect the true response to therapy in the synovial~     (joint) tissue and/or skin.~   "
38100|NCT02558348|"~     The purpose of Part 1 (Phase 1b) is to evaluate the general safety and tolerability of~     repeated 21-day cycles of AL3818 therapy, and to reevaluate the maximum tolerated dose~     (MTD).~      The purpose of Part 2 (Phase 2a) is to evaluate the efficacy of repeated 21-day cycles of~     AL3818 therapy preliminary efficacy of AL3818 in subjects with recurrent or metastatic~     endometrial, ovarian or cervical cancer.~   "
38101|NCT02558335|"~     The purpose of this study is to identify and quantify circulating tumor markers, which are~     associated with the presence of tumors. The current imaging available does not allow~     specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or~     swelling of the tumor after treatment before it shrinks). Our hope is that CTCs will~     provide a more accurate description of tumor state for high grade glioma patients.~   "
38102|NCT02558322|"~     The study explores the variation in the patient populations and describes regional~     differences regarding the reasons for consultations in the primary medical care in Germany.~     The data collection will be stratified by rural and urban areas as well as environs. The~     data set will include a large variety of data about physicians, patients and health care~     utilization.~   "
38103|NCT02558309|"~     The goal of this study is to examine in-vivo the effect of intraocular (IOP) and~     intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health~     has been an area of concrete research effort in recent years. The ability to acquire~     non-invasive and highly detailed information on both the eye and the brain using~     technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT)~     have paved the way to assess non-invasively the effect of ICP in-vivo. In this study, we~     will quantify the structural changes in the ONH in subjects with elevated ICP while they are~     treated to reduce the elevated pressure. This process will occur in a stepwise fashion over~     a period of time determined by the clinical treatment plans. We will apply controlled~     pressures to the eye during each step of ICP lowering while OCT images are obtained.~   "
38104|NCT02558296|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased~     risk of cardiovascular adverse events.~      The data from this study will be combined with the data from other bexagliflozin studies in~     a meta-analysis of CV safety outcomes.~   "
38105|NCT02558283|"~     This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in~     Chinese adults with nasolabial folds.~   "
38148|NCT02557724|"~     To study if the administration of corticoid hinder or enhance the mobilization of~     Mesenchymal Stem Cells (MSCs) in the peripheral blood during liver transplantation and~     whether this affects the outcome with respect to graft versus host response.~   "
38149|NCT02557711|"~     The aim of this study: 1. To evaluate the correlation between the clinic tools and~     ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of~     elastography/ ARFI imaging in spasticity evaluation of stroke patients.~   "
38106|NCT02558270|"~     Inhibition of SGLT2 by specific inhibitors has been shown to reduce the renal threshold for~     glucose excretion in patients with type 2 diabetes mellitus (T2DM) and control subjects~     leading to significant renal glucose loss even in the presence of normal glucose~     concentrations. SGLT2 inhibition with canagliflozin induces a 24h urinary glucose loss of~     around 70g in healthy subjects.~      Recent studies indicate that under fasting and postprandial conditions administration of~     SGLT-2 inhibitors leads to increase in endogenous (hepatic) glucose production (EGP)~     potentially counteracting the glucose lowering potency of these drugs. Dapagliflozin has~     been shown to acutely increase endogenous glucose production (EGP) and plasma glucagon~     concentrations under postabsorptive conditions within 2 hours after drug ingestion in~     patients with (T2DM). Glucagon binds to receptors in the liver and activates hepatic~     gluconeogenesis (GNG) and glycogenolysis, likely contributing to the observed increase in~     EGP.~      So far the likely interrelation between acute changes in hepatic glucose metabolism and~     energy turnover contributing to increased hepatic glucose production induced by SGLT2~     inhibition has not been studied. It is known that out of the 80% of oxygen consumption~     coupled to ATP synthesis, 7- 10% is used by GNG. However, so far the effects of~     dapagliflozin on acute changes in gluconeogenesis (GNG) and ATP turnover in hepatic tissue~     and on the time course of hormones involved in hypoglycaemia counter regulation have not~     been studied.~   "
38107|NCT02558257|"~     Objectives:~      Primary Objective The primary objective is to determine patients' perceptions of the~     timeliness of their referral to an outpatient palliative care clinic.~      The secondary objectives are to determine:~        1. The factors and variables associated with perception of timeliness such as age, gender,~          and symptom distress~        2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD~          Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room;~          and~        3. If there is an association between level of distress (physical, psychological, and~          spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the~          usefulness of the referral to palliative care center.~   "
38108|NCT02558244|"~     The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with~     neuroblastoma, at the time of their initial presentation, as a prognostic factor for~     prediction of subsequent outcome & complications related to surgery, in the accordance with~     the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in~     Upper Egypt.~   "
38109|NCT02558231|"~     The objective of this clinical trial is to compare the efficacy and safety of an initial~     triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral~     treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve~     patients with pulmonary arterial hypertension.~   "
38110|NCT02558218|"~     Primary objective of the study is the assessment of the patients' discomfort and ocular~     redness following cataract extraction surgery by means of phacoemulsification and~     intraocular lens implantation.~   "
38111|NCT02558205|"~     The purpose of this study is to see if it is possible to establish a relationship between~     the blood flow and blood volume of liver tumors from CT body perfusion and the radiation~     dose deposited in the tumors from the radioembolization treatment as measured by PET/CT.~      The study will do this by:~        1. Measuring the blood flow and blood volume of tumors in the imaging data from a CT body~          perfusion~        2. Measuring the radioactivity in the tumors after the radioembolization treatment using~          PET/CT and then calculating the dose deposited in the tumor~        3. Using statistical analysis to assess the relationship between the dose and the~          perfusion parameters~      In addition, the research may help develop a method for calculating the dose of~     radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data~     obtained from the CT body perfusion scans.~   "
38112|NCT02558192|"~     Nosocomial infections are infections that occur from the time of 'entry in the hospital up~     to 48h after discharge. In most developed countries, the incidence of nosocomial infections~     in children is between 5% and 44% with the predominance of respiratory infections and~     gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce~     the effectiveness of treatment, significantly increasing hospital costs. Current measures~     for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance~     with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of~     the possible methods of prevention, between which has been already tested the use of~     probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of~     LGG against placebo, noted a significant reduction in the risk of gastrointestinal~     infections and respiratory infections in hospitalized children treated with LGG, compared~     with patients who received placebo. There are also evidence which demonstrate a potential~     role zinc in reducing the incidence of respiratory infections is that bowel. We thought,~     therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the~     role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial~     gastrointestinal and respiratory tract infections in pediatric wards.~   "
38113|NCT02558179|"~     This study is designed as a prospective evaluation of the diagnostic performance of the~     multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to~     identify known significant causative organisms in bacterial vaginosis/vaginitis and other~     major pathogens and normal commensals in symptomatic women during the reproductive years.~     Vaginal fluid samples will be split and tested with the comparator methods and Nugent score,~     with the results evaluated according to sensitivity, specificity, positive predictive value,~     and negative predictive value. Laboratorians performing each test will be blinded to the~     clinical history and any prior test results to minimize ascertainment bias.~      Each subject will be followed routinely for up to 6 weeks after initial visit for~     vaginosis/vaginitis by telephone or office visit at the discretion of the treating~     physician.~   "
38150|NCT02557698|"~     Epidermis that lacks moisture and/or sebum presents as dry skin, which is often~     characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier~     function may be compromised. Skin care practices to decrease the risk of development of dry~     skin and/or to improve dry skin condition have barely been investigated. Bathing with bath~     oils has been shown to increase skin hydration, thus helping to stabilize skin barrier~     function. Therefore, the aim of this study is to investigate the effect of bathing every~     other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum~     hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.~   "
38114|NCT02558166|"~     This study consists of two substudies.~      The first substudy:~      'Renal resistive index in critically ill patients with cardiogenic and septic shock'~      Design: cross-sectional observational~      Aim of this project is:~        1. to determine whether critically ill patients with cardiogenic and septic shock have an~          elevated Renal Resistive Index and~        2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic~          shock and shock due to sepsis/systemic inflammation (SIRS)~        3. to determine the relation between the (change in) renal vascular resistance and~             -  Markers of the systemic - and the microcirculation~             -  Fluid status as quantified by bioimpedance analysis~             -  Concomitant renal function~      The second substudy:~      'Predictive value of the Renal Resistive Index on ICU admission and its course for the~     development of acute kidney injury in critically ill patients with cardiogenic and septic~     shock'~      Design: longitudinal observational~      The aim of this project is:~        1. to determine whether the renal resistance index on admission to the intensive care unit~          can predict the development of acute kidney injury (AKI) in critically ill patients~          with shock~        2. to investigate if the renal resistance index on admission to the intensive care unit is~          an independent predictor of the development of AKI or depends on the severity and~          duration of shock and other known risk factors of AKI such as comorbidity and use of~          nephrotoxic drugs~      Aim of the large research project is to determine whether the Renal Resistive Index could~     become a monitoring tool for intervention studies aiming to prevent acute kidney injury or~     protect the kidney.~   "
38115|NCT02558153|"~     A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus~     standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients~     with haemodialysis access stenoses.~   "
38116|NCT02558140|"~     This first-in-human study consists of three parts. The primary purpose of Part I is to~     characterize the safety and tolerability of RO6874813 in participants with locally advanced~     and/or metastatic solid tumors whose disease has progressed despite standard therapy or for~     whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or~     recommended Phase II dose (RP2D) will be determined. In Part II the safety and tolerability~     of RO6874813 will continue to be characterized in participants with locally advanced and/or~     metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In~     addition, treatment-induced efficacy effects of RO6874813 will be assessed by functional~     imaging and paired tumor biopsies. The primary purpose of Part III is to demonstrate~     anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.~   "
38117|NCT02558127|"~     The combination of asthma and being a carrier of genetic variants (mutations and / or~     polymorphisms) in the CFTR gene variant would cause bronchial asthma with mucus~     hypersecretion. This phenotype is characterized by a more severe disease, in terms of~     control, quality of life, exacerbations and lung function, and a different asthma the~     bronchial hypersecretion without inflammatory phenotype.~   "
38118|NCT02558114|"~     The purpose of the study is to compare the efficacy, safety and recurrence rate of two~     therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute~     hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the~     viremia within 4 weeks of the start of treatment (12 vs 24 weeks).~      The purpose of the study is also improve the safety of treatment with Ribavirin by~     optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.~   "
38119|NCT02558101|"~     This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung~     cancer screening lung health check appointment. Patients will be individually randomised~     (1:1) to receive either control invitation materials or intervention invitation materials.~     Those who attend will undergo a lung health check and be invited to a baseline screening~     scan if eligibility criteria are fulfilled.~   "
38120|NCT02558088|"~     The objective of the study is to help establish a urinary threshold for salmeterol on the~     World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in~     competitive sports.~      Hence, there is no hypothesis as such.~   "
38121|NCT02558075|"~     Large scale, effective, low-cost, and evidence-based programs that can nimbly translate new~     research discoveries into prevention and care for psychosocial based problems are urgently~     needed. This study hopes to provide support for Mood-Lifters, a template for a low-cost~     evidence based program, so that investigators may fill this gap and relieve suffering for~     millions of people who are not getting adequate mental health care. Mood-Lifters provides a~     low cost, research based program designed to enrich people's lives and reduce psychological~     distress. It is designed to provide useful support, coaching and information. It seeks to~     help people enhance pleasure, engagement and meaning in their lives while minimizing~     depression, fear, loneliness and other negative feelings via a proprietary peer based~     program that offers weekly meetings and other flexible support options. The goal of this~     pilot study is to test the efficacy of this program. This is not traditional therapy, rather~     an educational supportive program similar to WeightWatchers, but for mental health.~   "
38122|NCT02558062|"~     Critically ill patients are often ventilated in dedicated critical care units to provide~     respiratory support. Despite best practice patients can often develop a condition called~     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their~     respiratory function, and changes on chest x-ray. The correct management for ARDS is~     identifying the underlying condition causing the deterioration and identifying appropriate~     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs~     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may~     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has~     significant mortality.~      Despite all the clinical and laboratory data at the investigators' disposal there remains~     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often~     given empirically. Therefore, there is an urgent clinical need for accurate methods to~     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As~     such, the investigating team have developed and synthesised an imaging agent called BAC ONE.~     BAC ONE will be instilled directly into the lungs of 12 patients (with and without lung~     infection) to assess whether it can label bacteria in the human lung.~   "
38175|NCT02557373|"~     The purpose of this study is to assess feasibility of rice bran consumption in weaning~     children and to identify dietary rice bran mediated changes to the stool microbiome and~     stool metabolome.~   "
38123|NCT02558049|"~     BACKGROUND: Proton pump inhibitors (PPIs) treat problems such as gastroesophageal reflux~     disease (GERD). In many patients with mild or moderate GERD, PPIs should be used for 1-2~     months but are often continued longer unnecessarily. This is a problem because PPIs may~     cause harm when used long-term. PPI use is associated with severe C. difficile infections,~     fractures and pneumonia. Canada's public drug programs spent $247 million on PPIs in 2012~     (not including Quebec or PEI). Due to concerns with long-term PPI use, patients may face the~     decision to continue their PPI, use a lower dose or stop and use on-demand (only when~     symptoms return). This decision should be made collaboratively between patients and~     clinicians, though patients tend to have a poor understanding of when reducing a drug is~     appropriate. Using a lower dose or using on-demand may be viewed as difficult because of the~     chance of symptoms returning. Patient decision aids (PDAs) inform patients on benefits and~     risks of treatment options and improve ability to make informed decisions and clarify~     values. OBJECTIVES: Develop a PDA to help patients with the decision to continue PPI or stop~     and use on-demand/use a lower dose. Evaluate whether: 1) the PDA changes patient preference~     to continue or stop and use on-demand/use a lower dose of PPI 2) the PDA improves patient~     knowledge and realistic expectations 3) patients and pharmacists feel they made a shared~     decision 4) there is a change in PPI prescribing 8 weeks post-PDA and 5) patients' choices~     match up with their values. METHODOLOGY: The PDA will be developed by a team of doctors,~     pharmacists and patients. It will be delivered during a visit with a pharmacist. Patients~     (n=54) will indicate which choice they prefer (continue PPI/stop or use lower dose) before~     and after going through the PDA. We will use Mcnemar's test to compare the number of~     patients preferring to continue their PPI before and after. We will evaluate whether there~     is a difference in knowledge test scores and expectations test scores before and after the~     PDA. After the PDA, we will ask patients and pharmacists to rate the extent to which shared~     decision making occurred and measure the agreement. Values/choice congruence will be~     evaluated using logistic regression. Eight weeks after patients have received the PDA, we~     will look at whether there is any reduction in PPI use.~   "
38124|NCT02558036|"~     Optimal patient head and neck position when performing videolaryngoscopy for endotracheal~     intubation has not yet been established.The investigators aim to assess the effect of two~     different positions on the laryngeal view obtained and success of tracheal intubation during~     videolaryngoscopy with two commercially available and well established videolaryngoscopes.~   "
38125|NCT02558023|"~     The objective of this study is to demonstrate that urapidil is not inferior to nicardipine~     for the treatment of hypertension associated with preeclampsia (PE) and that it is better~     tolerated.~        -  efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120~          min of study drug administration.~        -  safety endpoints : clinical and biological observation for any side effect. All infants~          will be observed in the neonatology unit (during 48h).~      Pharmacokinetic study included to study :~        -  transplacental transfer,~        -  transfer in breast milk,~        -  and neonatal elimination (premature babies of mothers treated with urapidil (less than~          33 WG))~   "
38126|NCT02558010|"~     Acute pain management following major surgical procedures in pediatric patients continues to~     be a challenge, especially after extensive posterior spine fusions.~      Spine surgery is particularly traumatic, initiating pain in both peripheral and central~     pathways. While the standard management of post-surgical pain involves a multimodal~     approach, opioids provide the predominant benefit. However, opioid use is associated with~     many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone~     may decrease total opioid consumption and adverse effects as well as improve satisfaction~     with pain management after scoliosis repair.~   "
38127|NCT02557997|"~     We aim at comparing markers of HIV reservoir, monocyte function and immune activation~     between antiretroviral therapy (ART)-naïve (chronic infection or primary infection),~     ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based~     regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte~     function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine,~     interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at~     different time points between baseline and week 48 post DTG-based regimen initiation in each~     group.~   "
38128|NCT02557984|"~     The purpose of this study is to determine how the dopamine and opioid system is involved in~     reward processing, specifically in cue-induced reward responding and reward impulsivity,~     using dopamine and opioid receptor antagonists in healthy participants. The investigators~     predict that particularly the dopamine challenge should alter cue-induced reward responding~     and reward impulsivity. Such effects would be of high interest for the treatment of~     disorders which involve impairments of reward processing such as addiction.~   "
38129|NCT02557971|"~     This study is a retrospective chart review of patients treated with BOTOX® for idiopathic~     Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine~     the rate of post procedural urinary retention requiring catheterization and identify factors~     that may predict urinary retention.~   "
38130|NCT02557958|"~     Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.~   "
38131|NCT02557945|"~     The purpose of this study is to test the effects of the drug gabapentin on brain function~     thought to be important in the development of schizophrenia. Researchers think that treating~     a brain region with gabapentin (the hippocampus) may reduce the risk for developing~     schizophrenia.~   "
38132|NCT02557932|"~     In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple~     therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for~     H. pylori.~   "
38133|NCT02557919|"~     This project proposes to evaluate the effectiveness of training Head Start staff to discuss~     tobacco use, shs reduction and cessation in their existing encounters with parents in~     reducing tobacco use and exposure. Understanding the facilitators and barriers to~     integrating the intervention into the Head Start system will support future efforts to~     address tobacco use and exposure in families with small children.~   "
38151|NCT02557685|"~     This study aims to document early changes in the distal gut microbiota (both fecal and~     mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate~     collaborative immunologic and metabolomic analyses.~      This will be an open label clinical trial of FMT to prevent further recurrence in patients~     who have suffered at least a third episode of Clostridium difficile infection (CDI) and who~     have previously been treated with oral vancomycin.~   "
38152|NCT02557672|"~     This will be the first prospective randomized controlled clinical trial directly comparing~     Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post~     cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a~     difference in bleeding and transfusion requirements in patients received PCC versus FFP?~   "
38153|NCT02557659|"~     This extended investigation is to provide continued physician access to the device and~     collect confirmatory safety and effectiveness data.~   "
48169|NCT02426554|"~     The feasibility of combining a motor and cognitive exercise program with dietary~     supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of~     prepubescent children.~   "
38134|NCT02557906|"~     Some women with breast cancer have their whole breast removed as part of their treatment~     (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are~     two main ways to create a new breast(i)using tissue from elsewhere on the body (autologous~     reconstruction )or (ii)using a silicone implant.~      In recent years, it has been reported that by using a material called an acellular dermal~     matrix (ADM) the results of breast reconstruction surgery using an implant can be improved.~     ADMs are materials which originally come from animal or human skin. They act like a sling,~     supporting the lower part of an implant beneath the skin.~      Although ADMs have been approved for used in breast reconstruction and are safe, there is~     very little high quality evidence to back up their reported benefits, and some studies have~     suggested their use may in fact increase complications.~      The main purpose of this study is to find out what the actual risks and benefits of using an~     ADM in breast reconstruction surgery are. The investigators will follow the progress of~     women who have an implant based reconstruction to observe if participants develop problems;~     what those problems are and how participants feel about the results of their surgery. The~     investigators also follow the progress of women who undergo autologous reconstruction or~     alternative reconstructive techniques using an implant for the same reasons.~   "
38135|NCT02557893|"~     Pregnant women at increased risk for back pain were studied during the second trimester and~     randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were~     assessed including physical function, quality of life and mood.~   "
38136|NCT02557880|"~     The purpose of this study will be to see if adolescents can advance bedtime above what can~     be accomplished by counseling alone simply by inputting their information into a sleep~     application diary and reporting this information back to their sleep doctor.~   "
38137|NCT02557867|"~     The purpose of this study is to study the effect of obesity in dexmedetomidine~     pharmacokinetics and pharmacodynamic profile.~   "
38138|NCT02557854|"~     The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior~     to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with~     recurrent and refractory solid tumors.~   "
38139|NCT02557841|"~     A crossover trial with healthy volunteers will be conducted. Three sessions will be~     performed with at least 48 hours washout period to minimize carry-over effects. In each~     session, volunteers will be submitted to: fatigue and attention levels evaluation,~     handwriting test, serial reaction time task (SRTT) before and after ctDCS conditions and~     after session, a performance perception evaluation.~   "
38140|NCT02557828|"~     Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the~     pressure. During arterial cannulation the artery can be located by palpation, but use of~     ultrasound has increased the success rate of cannulation. A new ultrasound technique for~     vascular cannulation (dynamic needle tip positioning) has been described. We aim to compare~     this technique to the palpation technique for arterial cannulation. We hypothesize that the~     use of this novel ultrasound technique will result in a higher first attempt success rate~     and overall success compared to palpation.~      We plan to enroll 310 patients in this study. The participants in the study will have been~     deemed by the attending anesthesiologist to require a radial arterial line for the operation~     and thus the research protocol will not involve a deviation from the standard of care.~   "
38141|NCT02557815|"~     This current project investigates the effect of a single session of right dlPFC repetitive~     transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol~     dependent patients and healthy controls.~   "
38142|NCT02557802|"~     The investigators will explore in an experimental medicine healthy human model of~     immunisation, whether switching the route of sequential administration of licensed influenza~     vaccines can result in an immune response that is broader in its ability to recognise~     different substrains of influenza viruses. The investigators will do this by initially~     giving an immunisation with a nasal or an injected vaccine, and then switching subjects over~     to receive a second dose one month later (when the cellular component of immunity will have~     matured) via the opposite route (nasal->injected or injected->nasal). The investigators will~     use research assays that can map the different parts of the influenza virus that the~     vaccinated person's immune cells recognise at baseline, after the first immunisation, and~     then again after the second, to see if the breadth of the recognition has broadened to~     include new strains or virus components. Should this pilot study give an indication that the~     breadth has widened (rather than just a further boost to the same responses seen after the~     first immunisation) it will provide justification for a larger study in which statistical~     significance may be powered for observed changes.~      The study is funded by ADITEC, which is a collaborative research programme that aims to~     accelerate the development of novel and powerful immunisation technologies for the next~     generation of human vaccines.~   "
38143|NCT02557789|"~     A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate~     release tablet formulation of lefamulin when administered to fed and fasted healthy subjects~     in comparison to an intravenous formulation and a capsule formulation.~   "
38144|NCT02557776|"~     The overall purpose of the study is to evaluate a method for offering mutation analysis of~     BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at~     diagnosis and family history. Information about the study as well as pre-test genetic~     counseling will primarily be given in a written way. In addition to that, if a study~     participant wishes to, she can also receive pre-test telephone genetic counseling.~   "
38145|NCT02557763|"~     The aims of this study is to compare the results between patients without severe~     patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile~     bearing UKA.~      The investigators prospective compute the results including anterior knee pain, knee society~     score, pain score, functional score, range of motion, operative time, blood loss, and~     component alignment.~   "
38146|NCT02557750|"~     The aim of this study is to retrospectively investigate the effect of combined modality~     treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance~     with the experience at the pediatric oncology department at South Egypt Cancer Institute.~   "
38147|NCT02557737|"~     The aims of this study were to compare the injection locations of key spastic muscles on~     upper extremity by three different guidance localization methods ( surface anatomy landmark,~     ultrasonography, electric stimulation) and the effectiveness.~   "
38155|NCT02557633|"~     There is increasing evidence that the effectiveness of allergy immunotherapy to control~     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid~     administered during a single regimen of subcutaneous (SC) injections or of sublingual~     administration.~      Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are~     being developed to compare with the current dose of 5100 SU. The purpose of this study is to~     evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA~     MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due~     to grass pollen, to enable selection of the best dose to go into a larger scale study to~     assess the efficacy and safety of the higher cumulative doses.~   "
38156|NCT02557620|"~     This trial is conducted in Europe. The aim of this trial is to compare the steady-state~     exposure of semaglutide administered subcutaneously once daily to semaglutide administered~     subcutaneously once weekly in healthy subjects.~   "
38157|NCT02557607|"~     A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating,~     repeatable over time, appears promising in the field. This sequence allows for routine,~     generate perfusion maps relating to the entire brain volume~   "
38158|NCT02557594|"~     This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg~     and Viread 300mg after a single oral dose in healthy male volunteers.~   "
38159|NCT02557581|"~     The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been~     well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of~     the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic~     stimulation for muscle adaptations in humans.~   "
38160|NCT02557568|"~     The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection,~     notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce~     the rate of S. aureus infection in this category of patients although the risk of emergence~     of antimicrobial resistance persists. Approximately one quarter of the general population is~     colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main~     categories of nasal carriers have been historically identified: persistent carriers (20%,~     12-30%]), intermittent carriers (30%, [16-70%]) and non-carriers (50% [16-69%]). By contrast~     to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of~     S. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.~      Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of~     carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the~     carried strain. However, there is no consensual definition of this persistent carriage~     state. In previous studies, 5 to 12 nasal sampling episodes were realized for a period~     ranging from 5 weeks to 8 years. The index of carriage, corresponding to the number of~     samples positive for S. aureus divided by the total number of samples, has been proposed to~     standardize the definition of the carriage state. According to standard tools, it is almost~     impossible to determine the nasal carriage state in routine practice.~      Recently, an algorithm based on one or two quantitative cultures from nasal samples taken~     within 2 days that was able to distinguish accurately persistent and non-persistent nasal~     carriers of S. aureus has been described; only one nasal sample was needed in more than 9~     cases out of 10. The aim of the present study was to assess prospectively the reliability of~     this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to~     check its ability for identifying patients with the highest risk of S. aureus infection~   "
38161|NCT02557555|"~     The purpose of this study is to learn how the investigators can better educate pregnant~     patients about the options open to them for pain relief during labor. Patients will receive~     educational pamphlet during prenatal clinic visit and again on admission to labor and~     delivery. The options for analgesia will be discussed by anesthesia care provider. Patient~     will be asked to complete a survey on the post partum unit.~   "
38162|NCT02557542|"~     A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for~     the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of~     patients This will be a pilot study which is designed to provide us with enough information~     for a potentially larger multicentre randomised controlled study.~   "
38163|NCT02557529|"~     72 patients with head and neck cancer, undergoing primary treatment with radiation therapy~     and concomitant weekly cisplatin, will be recruited to this multicentre trial.~      Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control~     arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre,~     gender, p16-status and body mass index (BMI) below or above 30.~      Primary endpoint is difference in change in lean body mass (LBM) between the groups and the~     endpoint is reduction of LBM loss in intervention arm by 25% compared to control.~      Secondary endpoints include side-effects to treatment, change in body composition, physical~     function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary~     exercise and work affiliation will also be registered.~      Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for~     proteomics analyses and histological analyses.~   "
38164|NCT02557516|"~     Combination study of IPH2201 with Ibrutinib in relapsed or refractory Chronic Lymphocytic~     Leukemia (CLL) patients in 2 parts :~        -  phase 1b : a 3+3 design to assess the Maximum Tolerated Dose (MTD)~        -  phase 2a: to evaluate the anti-leukemic activity of the combination~   "
38165|NCT02557503|"~     To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or~     without concomitant vascular invasion and extrahepatic metastases unresectable advanced~     primary liver cancer~   "
38166|NCT02557490|"~     The purpose of this study was a randomized controlled trial to compare the effect of~     oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE~     hepatic artery infusion~   "
38167|NCT02557477|"~     The primary objective was to assess whether supplementation of Omega 3/6 fatty acids~     improves mainstream schoolchildren's reading ability. The secondary objective was to assess~     whether Omega 3/6 improves cognitive functions such as attention, memory, learning,~     language/communication, problem solving and social ability.This was a 3-month randomised,~     double-blind, placebo-controlled study followed by one-way crossover (placebo to active~     treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were~     initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo.~     All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome~     measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities.~     Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder~     (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and~     problem solving); Social and Communication Disorders Checklist (to evaluate social ability)~   "
38305|NCT02555670|"~     Aim of the present study is to determine whether muscle mass as assessed by bioelectrical~     impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan~     analysis in critically patients admitted to the intensive care unit.~   "
38168|NCT02557464|"~     The objective of this study is to identify early and accurate semantics markers of~     Alzheimer's disease (AD) by using two types of methods. First, the investigator will~     evaluate semantic processing of patients with AD or related disorders which will be compared~     to age matched controls by taking neuropsychological tests. Then, the investigator will~     analyze the effect of contextual word predictability on eye movements in reading sentences~     with the help of the same participants by using an eye tracker. Both of these methods will~     be used twice with a time interval of 6 months.~   "
38169|NCT02557451|"~     AMD is a disease of the central retina, a zone that enables fine detail activities (reading,~     detail…). This central zone of the retina can be affected by a haemorrhagic complication~     when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic~     approaches are currently available even though they have never been truly compared. The~     study will be proposed to patients who need to be treated for haemorrhage of the macula. A~     certain number of factors will be evaluated to compare the 2 principal approaches currently~     used in France: surgery followed by injections of an anti-angiogenic OR intravitreal~     injections of gas followed by injections of anti-angiogenics. This is a multicentre,~     randomized controlled trial to compare these 2 therapeutic approaches.~      These diametrically opposed approaches have very different consequences for patients and in~     terms of cost for society. The consequences for patients will be immediately measurable so~     as to determine the best therapeutic approach in terms of functional recovery and the impact~     of the disease on quality of life, while taking into account the risks inherent to these 2~     treatments. The impact on quality of life of these 2 approaches as well as their~     consequences - an important factor in this disease, which is a cause of sensory handicap -~     will provide the ophthalmological community with essential information making it possible to~     validate one or the other of these methods for the management of these haematomas.~   "
38170|NCT02557438|"~     The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric~     bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 14-21. This~     study will also examine a group of overweight boys and girls who are not scheduled or~     planned for surgery for comparison of these outcomes.~      Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone~     strength. The investigators do not know the effects of such surgery on bone in teenagers and~     young adults. The purpose of this study is to find out how different types of weight loss~     surgery affect bone density and strength in teenagers and young adults and compare these~     results to obese teenagers and young adults who are not undergoing weight-loss surgery.~   "
38171|NCT02557425|"~     Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium~     falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical~     immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often~     without clinical symptoms in the mother. The systemic and placental changes that occur with~     malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury~     strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no~     published studies to date on the impact of malaria in pregnancy on childhood ND. This study,~     conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and~     define mechanisms by which malaria may lead to ND impairment including micronutrient~     deficiencies. ND outcomes will be measured by the following neuropsychological and~     behavioral tests: Mullen Scales of Early Learning, the Color Object Association Test, the~     Early Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory~     of Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24~     and 36 months of age. This study will be nested in an ongoing Ugandan IRB approved~     interventional trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the~     PROMOTE-II protocol for research purposes. Some of that blood will be used to test for~     micronutrient deficiencies as well as other immune responses to malaria.~   "
38172|NCT02557412|"~     OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with~     conventional treatment, improves the lipid profile of patients with dyslipidemia and~     mild-moderate apnea-hypopnea syndrome (OSA).~      Secondary objectives:~        -  Determine the additional effect of CPAP on insulin resistance and dyslipidemia in~          patients with mild-moderate OSA.~        -  Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with~          dyslipidemia and mild-moderate OSA.~      DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional~     treatment.~      STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and~     in stable treatment during the last month with diet, cholesterol lowering drug, and~     cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.~      Sample size. 38 patients who completed the test in each treatment arm.~      TREATMENT~      Patients will be randomized to one of the following treatment arms form:~        1. hygiene and dietary recommendations.~        2. lifestyle intervention (more strict and promotion of daily physical activity and~          dietary control).~        3. Treatment with positive airway pressure (CPAP).~      ENDPOINTS:~      Efficacy endpoints.~        -  Primary endpoint: LDL-cholesterol.~        -  Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high~          sensitivity (hsCRP).~        -  Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α),~          oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell~          adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)),~          sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin~          A / hypocretin-1 and ghrelin).~        -  Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model~          Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI),~          thyroid-stimulating hormone (TSH).~        -  Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep~          Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).~      Security endpoints.~        -  Notification of clinical adverse events.~        -  Compliance with CPAP (average hours use per day).~        -  Epworth Sleepiness Questionnaire.~        -  Development of cardiovascular events.~   "
38173|NCT02557399|"~     This is a multicentre, randomized, single-blind (investigator is blinded), active (the~     combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group~     study in Japanese subjects with facial acne vulgaris. The purpose of this study is to~     evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3%~     (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus~     combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne~     vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will~     use Duac® fixed dose combination gel with quantity sufficient to cover entire face~     (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or~     combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including~     the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel~     twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.~   "
38174|NCT02557386|"~     To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in~     unilateral cruciate ligament of the knee reconstruction surgery.~   "
38176|NCT02557360|"~     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to~     several symptoms such as intractable pruritus or chronic fatigue, significantly impairing~     patients quality of life. Recent studies show, that chronic liver diseases are associated~     with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for~     the synthesis of SAMe from methionine. SAMe deficiency is associated with impaired~     detoxification and hepatoprotection and exacerbate liver injury. Supplementation with SAMe~     has proven useful in several liver diseases.~      The study group will include 20 patients with PBC diagnosed with European Association for~     the Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic~     acid (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months.~     Both clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and~     urine bile acids metabolites, transient elastography and health related quality of life.~   "
38177|NCT02557347|"~     The objective of this study is to determine the effectiveness of treating peritoneal~     dialysis (PD) patients with fluid overload by a structured nurse-lead intervention protocol.~     We plan to recruit 100 PD patients with fluid overload. These patients will be assessed and~     managed by a renal nurse specialist in the ambulatory renal center according to a~     standardized protocol. The improvement in the degree of overhydration will be determined by~     bioimpedance spectroscopy 4 and 12 weeks after treatment.~   "
38178|NCT02557334|"~     The purpose of this study is to evaluate the effects of freeze dried strawberry powder on~     LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and~     other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive~     compounds in freeze dried strawberry powder may elicit beneficial effects on LDL~     cholesterol, as well as blood pressure and arterial health.~   "
38179|NCT02557321|"~     This is an international multicenter, open-label, sequential phase study of intralesional~     (IL) PV-10 in combination with immune checkpoint inhibition. Stage IV metastatic melanoma~     patients with at least one injectable cutaneous or subcutaneous lesion who are candidates~     for pembrolizumab will be eligible for study participation. In the Phase 1b portion of the~     study, all participants will receive the combination of IL PV-10 and pembrolizumab (i.e.,~     PV-10 + standard of care). In the subsequent Phase 2 portion of the study participants will~     be randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or~     pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care).~   "
38180|NCT02557308|"~     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in~     Patients with Ankylosing Spondylitis~   "
38181|NCT02557295|"~     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in~     Patients with Rheumatoid Arthritis.~   "
38182|NCT02557282|"~     The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed~     Tomography (CT) Perfusion (investigational device) imaging performance. Evaluation of CT~     Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS~     with CT Perfusion Module.~   "
38183|NCT02557269|"~     ASIT naïve patients sensitized to grass pollens will be recruited for the study. All of them~     will be instructed to treat bothersome in-season symptoms when they appear (on as needed,~     pro re nata basis) with rescue medication. They will be given 5 different options and will~     be informed about the effects of each of them in order to make their optimal choice for~     different symptoms and their combination: local decongestant (xylomethazoline, when~     congestion is leading), local antihistamine (azelastine, when itching, sneezing and~     rhinorhea a predominant), nasal corticosteroid (momethasone, when all nasal symptoms are~     pressing and no adequate relief is obtained form the other 2 local treatments), oral~     antihistamine (bilastine, when itching and sneezing persist despite the local treatments)~     and oral corticosteroid (prednisolone, when any or all symptoms become unbearable despite~     the other suggested treatments). Patients who are reluctant to use immunotherapy or who are~     too late to initiate it will be randomized to be treated with the listed medications on as~     needed basis, the nasally applied formulations will be followed by either HPMC to prolong~     and enhance their effect (Group HPMC) or placebo (lactose powder) (Group Placebo) to serve~     as control. Patients indicated and willing to carry out ASIT will be treated according to~     the standard protocol with grass allergens sublingually (Staloral #688) and will receive~     rescue medication (Group Immunotherapy).~   "
38184|NCT02557256|"~     The aim of the study is to retrospectively review data about malignancies that arise~     primarily in the pelvis and/or in the pelvic organs, in pediatric cancer patients &~     categorize the spectrum of these malignancies according to experience at South Egypt Cancer~     Institute which is the largest referral site in Upper Egypt.~   "
38185|NCT02557243|"~     The aim of this study is to identify demographic & disease characteristics in pediatric~     oncology patients diagnosed with soft tissue & bone tumors involving the extremities &~     treatment outcomes in these patients.~   "
38186|NCT02557230|"~     The aim of this study is to identify demographic & disease characteristics in pediatric~     oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these~     patients.~   "
38187|NCT02557217|"~     NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a~     treatment for people after they have had a heart attack (MI).~   "
38188|NCT02557204|"~     The primary aim of this study is to investigate the difference in the first attempt and~     overall success rate of different techniques for insertion of nasogastric tube. Secondary~     aim is to investigate the difference of the duration of insertion using the selected~     technique, complications during insertion such as kinking, knotting, mucosal bleeding~   "
38189|NCT02557191|"~     Approximately 2% of neonates in the US are born very preterm. Preterm births are associated~     with impaired cognitive, language and motor function, and increased risk for autism spectrum~     disorders. Epidemiological studies indicate a dose-response relationship between gestational~     age at delivery and cognitive impairments, with the most immature of newborns being the most~     susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term~     neurocognitive impairments are currently lacking. The investigators seek to identify~     epigenetic markers that mediate the relationship between adverse prematurity-related~     exposures and neurocognitive impairments. The overarching hypothesis of this proposal is~     that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very~     preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive~     impairment in childhood.~   "
38190|NCT02557178|"~     Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to~     motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete~     home exercise as part of pulmonary rehabilitation (PR). The proposed system has two~     components: home-based activity monitoring and health coaching. The investigators will~     conduct a randomized, wait-list controlled clinical study to evaluate the effects of the~     activity monitoring system and health coaching on quality of life and daily steps.~   "
38191|NCT02557165|"~     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary~     disease (COPD) and can affect both respiratory and peripheral muscles. Impaired muscle~     regeneration is thought to be implicated in the process of muscle atrophy. In this study the~     investigators will evaluate muscle regenerative potential of the Vastus Lateralis (VL) and~     diaphragm of patients with COPD, compared to patients with normal lung function.~   "
38192|NCT02557152|"~     The purpose of this registry is to gain a real world perspective for the use and outcomes~     associated with the Sonendo® GentleWave System usage. The registry population includes up to~     500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical~     sites in the United States.~   "
38193|NCT02557139|"~     Bioavailability, Phase I study to evaluate the clinical performance of the tablet~     formulation in the fasted and fed states, in comparison to the capsule formulation in the~     fed state.~   "
38194|NCT02557126|"~     The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate~     Lowering Effect of URC102 in gout patients.~   "
38195|NCT02557113|"~     Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral~     body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate~     of cement leakage is of value and makes the procedure safer.The aim of this study was to~     investigate the effect of the creation of a cavity on cement leakage during vertebroplasty.~     Investigators tested the hypothesis that the creation of a merely small and irregular cavity~     in vertebral body prior to cement injection would reduce cement leakage.~   "
38196|NCT02557100|"~     The purpose of this study is to examine changes in immune cells and proteins in response to~     treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus~     adalimumab, both given in combination with methotrexate.~   "
38197|NCT02557087|"~     The aim of this study is to assess whether hyoscine butylbromide is as effective as~     pethidine for analgesia during the first stage of labor.~   "
38198|NCT02557074|"~     In a prospective pilot study the investigators showed that low doses of IL2 could be~     beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients~     treated.~      The objective of this study is to compare the long term efficacy of low doses of IL2 versus~     placebo in a multicenter prospective randomized double blind study.~   "
38199|NCT02557061|"~     Colorectal cancer (CRC) is one of the most common cancers in France (36,000 new cases /~     year) and nearly 16,000 people die each year from this disease. The lymph node involvement~     of the surgical specimen is today the main tool on which is based the adjuvant treatment~     decision after curative surgical resection. The study of new predictive factors to identify~     patients at risk for developing a local or metastatic recurrence is therefore a major~     challenge.~      It is now clear that the immune system plays a role in the control of tumor's development,~     and it was shown that there was a correlation between the presence of a CD3+ T-lymphocyte~     infiltrate in colorectal cancers and patient survival. Preliminary studies suggest an~     important role of regulatory T-lymphocyte in the modulation of the antitumor immune~     response. The aim of our study is to follow a cohort of patients operated for colon cancer~     with curative intent to highlight the prognostic characteristics of the tumoral infiltrate~     by various lymphocyte populations (particularly T-lymphocytes but also B-lymphocytes and~     regulatory lymphocytes). It will be performed a preoperative analysis of blood circulating~     lymphocytes with antibodies specific for different cell populations (CD3, CD4, CD8, CD56,~     CD16, CD19, CD2) and stage of activation (CD25, CD69, HLA-DR ) or differentiation (CD24,~     CD38, CD27, CD103, CD62L, CCR7, CD45RA / RO, IgD). The presence of regulatory T-lymphocytes~     will also be analyzed. It will be performed on tumor sample a Tissue Microarrays for~     immunohistochemical study to determine the presence of different lymphocyte populations. We~     systematically study the markers CD68 (monocytes / macrophages), CD56 (NK cells), CD20 and~     CD79a (B cells / plasma cells), CD3 (T cells), CD8 (cytotoxic T), CD4 (helper T) FoxP3~     (regulatory T), cytotoxicity of CD8 markers (Fas ligand, perforin and granzyme) and MHC I~     (antigen presentation) to explore the innate and adaptive immune responses. For each~     section, the different zones will be analyzed (center and invasive margin and healthy~     tissue). The main objective of the study is the influence of the tumor infiltration rate by~     CD3 + T cells on disease free survival at 2-years in patients with non-metastatic colon~     cancer resection. The secondary objective is to search a correlation between the rate of~     T-lymphocytes on preoperative blood sample and on tumor sample.~   "
38200|NCT02557048|"~     The aim of the study is to identify demographic characteristics, various histopathologies,~     and site preferences for each disease entity of malignant head and neck tumors in pediatric~     oncology patients & treatment outcomes in these patients, according to experience at South~     Egypt Cancer Institute which is the largest referral site in Upper Egypt.~   "
38201|NCT02557035|"~     PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of~     palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25~     mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral~     dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron~     0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent~     nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after~     administration of a single cycle of highly emetogenic chemotherapy~   "
38202|NCT02557022|"~     A low glycemic index (GI) diet has been associated with improved glycemic control in type 2~     diabetes patients and a reduced risk of cardiovascular disease (CVD). Low glycemic load (GL)~     diets have been associated in cohort studies with a reduction in both diabetes incidence and~     CVD events, especially in overweight individuals, and have been recommended by the Canadian,~     American and European diabetes associations. Life style modification trials have shown that~     reducing body weight in overweight or obese individuals improves obesity-related risk~     factors. The process of a systematic review combines the results from many studies in order~     to arrive at a pooled weighted average of the true effect. The investigators propose to~     conduct a systematic review and meta-analysis of the highest quality evidence from~     randomized controlled trials to assess the effect of low GI/GL diets on body weight change.~     The results of this synthesis will inform clinical practice guidelines and lead to better~     health outcomes through informing healthcare providers and patients, stimulating industry~     innovation, and guiding future research.~   "
38335|NCT02555267|"~     This study investigate the impact of comprehensive geriatric assessments using activity of~     daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity~     index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma~     (DLBCL) treated with R-CHOP.~   "
38203|NCT02557009|"~     The study is designed as a prospective observational study. Each participant will have their~     BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for~     routine patient monitoring. Measurements will be recorded on an hourly basis during the day~     and for as many days as possible if the required measurements are being made for clinical~     care.~      Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of~     convenience sampling. Data will be analyzed using a test of equivalence on the initial~     measurements (test of equivalence between two means) and then over time (repeated~     measurements) with a linear mixed-effects model.~   "
38204|NCT02556996|"~     This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian~     children 6-18 months of age. The primary aim of the study is to determine the protective~     efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine~     against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen~     over a one year period of follow-up by active surveillance. The vaccine consists of a~     mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors~     and recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation~     is heat-killed Escherichia coli K-12 bacteria.~   "
38205|NCT02556983|"~     The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute~     appendicitis, by using of dose simulation technique and iterative reconstruction.~   "
38206|NCT02556970|"~     This study seeks to establish if thoracoscopic surgery performed through a single port or~     incision reduces early post-operative pain compared with conventional multiple port~     thoracoscopic surgery.~      This initial pilot study is designed to establish whether a trial of the two techniques is~     acceptable to patients, clinically feasible and can be delivered in a reasonable timescale.~   "
38207|NCT02556957|"~     Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV hotspot~     with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service~     utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations,~     compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have~     recognized the urgent need to target hotspots with enhanced HIV treatment and prevention~     efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies~     for hotspots is limited and is thus a priority need for the field.~      The investigators propose an implementation science, cluster-randomized, controlled trial in~     Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting~     combination HIV prevention (CHP) services supported by mobile health technologies (mHealth).~     CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing~     and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to~     maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV~     incidence, most community members must be assessed for risk factors and current CHP~     utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The~     proposed intervention will use low-cost CHWs leveraging mHealth decision support and~     counseling tools to promote CHP along this entire continuum of HIV service utilization. The~     hypotheses for this implementation science research are that residents in clusters receiving~     the implementation intervention will have improved CHP service uptake and decreased~     Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.~      The intervention will be evaluated through a pragmatic, cluster-randomized trial nested~     within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort~     Study (RCCS). Intervention arm participants will be visited in their place of residence by~     CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP~     health counseling, linkage, and adherence support, all supported by a mHealth decision~     support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes~     will be HIV incidence, population viral load, implementation measures, retention, virologic~     suppression, and sexual behaviors.~      Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial~     will be conducted to evaluate implementation processes, facilitators, and barriers to inform~     study results and future program uptake. Focus groups and in-depth interviews will be~     conducted during and after the follow-up period and synthesized with quantitative data.~     Intervention costs will be prospectively measured to provide information on program~     affordability.~      Through this study, a novel, low-cost, and scalable implementation intervention to improve~     CHP uptake will be evaluated in an HIV hotspot critical to controlling the HIV epidemic.~     The study design ensures rigorous evidence of immediate relevance to many stakeholders.~   "
38208|NCT02556944|"~     To assess postsurgical visual acuity (distant, intermediate, near), refractive errors,~     contrast sensitivity, visual function and patient satisfaction after implantation of~     multifocal IOLs of different add power contralaterally.~   "
38209|NCT02556931|"~     To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell~     transplant in certain malignancies that are considered difficult to engraft.~   "
38210|NCT02556918|"~     The purpose of this study is to determine whether treatment with sitagliptin reduces the~     frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to~     determine whether treatment with sitagliptin is effective in maintaining blood sugar control~     in patients with type 2 diabetes (T2D).~   "
38211|NCT02556905|"~     The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the~     safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to~     the approved package insert, after approval of marketing authorization for new drug in~     Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected~     and evaluated. This DUE is a multi-centre, observational and non-interventional~     post-marketing surveillance.~      The patients can be recruited through both Drug Use Examination after the initiation of Post~     Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was~     performed before REVLIMID® reimbursement.~      Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for~     safety assessment has been conducted by site monitoring process by 07Dec2016.~      REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug~     Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs),~     unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety &~     efficacy of the drug.~      It is necessary to examine patients' demographics and baseline characteristics, medical~     history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and~     final efficacy (best response) assessment.~   "
38212|NCT02556892|"~     The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants~     with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma~     (SLL).~   "
38213|NCT02556879|"~     Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor~     specific antibodies (DSA) is an underestimated factor in liver transplantation and may~     contribute to dysfunction and graft loss , especially among candidates for~     retransplantation, that have major immunization.~      This study will analyzed immunization markers at the time of liver retransplantation and~     systematically in patients follow-up. This will allow to characterize the histological~     lesions due to humoral immunization, to establish further investigations and to adapt early~     immunosuppressive therapy.~   "
38214|NCT02556866|"~     Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in~     combination with corticosteroids to corticosteroids plus placebo in the treatment of~     non-infectious active mixed cryoglobulinemia vasculitis.~   "
38215|NCT02556853|"~     The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The~     correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®)~     for the patients of the one group (group U) and by clinical examination for the patients of~     the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®).~     The two methods will be compared in terms of sensitivity and specificity. The main purpose~     of the study is to determine if the ultrasound can be used for determination of the correct~     placement of the left sided double lumen endotracheal tube~   "
38242|NCT02556502|"~     The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological~     criteria.~      Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau +~     phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF~     biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are~     unclassifiable.~      18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET),~     selectively binds to amyloid plaques, with high detection sensitivity (98%).~      Detection of amyloid plaques by PET imaging separate patients according to the criteria of~     Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.~      If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent~     initiating unnecessary treatment, expensive for the community.~      This is the first imaging study of amyloid plaques targeting population whose diagnosis of~     AD is uncertain according to the CSF biology.~      The aim of this study is to describe the results of amyloid PET in case of intermediate CSF~     biology and to separate patients as AD or not according to the criteria of Dubois~   "
38216|NCT02556840|"~     Maturity-onset diabetes of youth (MODY) are the most frequent monogenic diabetes with~     autosomic dominant inheritance (2% of diabetes). The MODY2 diabetes is related to a defect~     in the glucokinase (GCK) enzyme, the first limiting step of insulin secretion. An abnormal~     GCK leads to a delayed insulin secretion. Patients with GCK mutations have only mild raised~     fasting plasma glucose. Treatment is usually unnecessary since hyperglycemia is stable and~     MODY2 patients have no microvascular complications of diabetes. In contrast, pregnancy in~     MODY2 women is a challenging situation. A non-mutated fetus will produce excess insulin in~     response to raised maternal blood glucose leading to an accelerated growth and a higher risk~     of macrosomia. The mother of non-mutated fetus should therefore be treated to normalize her~     blood glucose levels. On contrary, a mutated fetus will produce a delayed insulin secretion~     (as his MODY2 mother) in response to maternal hyperglycemia. Consequently insulin therapy~     during pregnancy would reduce fetal insulin secretion and result in a low birth weight.~      Moreover, insulin therapy exposes pregnant women to more labor induction, prematurity and~     cesarean deliveries. In these MODY2 women whose glucose set point is physiologically higher,~     glycemic goals are difficult to achieve while often requiring extensive insulin therapy. An~     optimal situation would consist in initiating insulin therapy only for women with~     non-mutated offsprings. Unfortunately no antenatal diagnosis of the GCK mutation on fetal~     cells is available yet. In literature, birth weight differences between mutated and~     non-mutated neonates may reach up to 700g. In clinical practice, two strategies are used but~     without standardized protocol on glycemic targets, delay and doses of insulin : 1) insulin~     at diagnosis of pregnancy 2) treatment based on fetal abdominal circumference and fetal~     weight measurements by ultrasonography (US) and initiated if fetal biometry is greater than~     the 75th percentile.~      The purpose of the study is to evaluate for the first time these two management strategies~     through a prospective and standardized study. Hypothesis: US assessment would be sufficient~     to identify fetuses at risk of macrosomia and to initiate insulin treatment in mothers.~   "
38217|NCT02556827|"~     Aim of study is to determine reactive oxygen products and antioxidant capacity with rosacea~     patients; to measure metalloproteinase level and inflammatory markers of immune response and~     investigate their corelation with demodex infestation and also investigate the role of~     photoaging and sebum secretion in rosacea.~   "
38218|NCT02556814|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of caffeic acid tablets combining with high-dose~     dexamethasone for the treatment of adults with newly-diagnosed primary immune~     thrombocytopenia (ITP).~   "
38219|NCT02556801|"~     The purpose of this study is to assess safety, tolerability and demonstrate a dose response~     signal using Total Symptom Score (TSS), based on challenges with grass pollen in an~     Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose~     of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.~      The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.~   "
38220|NCT02556788|"~     Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks~     in subjects with acne vulgaris.~   "
38221|NCT02556775|"~     The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20~     antibodies), regarding the course and outcome of pregnancy in women ever treated with~     HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be~     followed.~   "
38222|NCT02556762|"~     This randomized phase III trial is to compare simultaneous modulated accelerated boost with~     standard dose radiotherapy given together with chemotherapy in treating patients with~     esophageal squamous cell carcinoma.~   "
38223|NCT02556749|"~     The purpose of this study is to evaluate the effects of cranberry juice on central and~     peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein~     concentrations and size characteristics, and HDL function. The investigators hypothesize~     that the bioactive compounds in cranberry juice may elicit beneficial effects on blood~     pressure and arterial health, as well as LDL-C and HDL function.~   "
38224|NCT02556736|"~     RST-001 is a gene therapy given as an injection into the eye and delivers a gene encoding a~     photo switch, channelrhodopsin-2, (optogenetics) to cells in the retina of the eye. When~     expressed, the channelrhodopsin-2 protein can depolarize in response to light thus~     generating a signal that is transmitted to the brain.~      The study is composed of two parts. An initial dose-ranging study (part 1) is proposed~     whereby three dose levels of RST-001 will be studied in three separate groups of adult~     patients with advanced disease. This first part of the study is aimed at determining a~     single dose of the experimental agent which is safe and well tolerated, to further evaluate~     in a fourth group of patients. The second part of the study is aimed at obtaining additional~     safety data at the highest tolerated dose and providing important additional clinical data~     to guide the design of future efficacy studies.~   "
38225|NCT02556723|"~     Diabetic macular edema (DME), wet-AMD and macular edema secondary to vein occlusions are the~     leading cause of blindness in developed countries. Several therapies have been studied as~     such laser treatment and intravitreal injections of corticosteroids or anti-VEGF drugs. In~     terms of public health the long term treatment with the current available drugs is very~     expensive and new therapies with the same or better effect should be investigated. This~     study intends to evaluate the efficacy and safety of intravitreal injections of~     ziv-aflibercept for the treatment of patients with DME, wet-AMD and macular edema secondary~     to vein occlusions.~   "
38226|NCT02556710|"~     This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™~     in adults with pain due to osteoarthritis of the knee~   "
38227|NCT02556697|"~     Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and~     microvessels, characterized by the occurrence of fibrosis and vascular obliteration~     phenomena. The alterations in lung microvessels are found in pulmonary involvement of~     scleroderma, which are the most serious complications of the disease.~      In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are~     involved in the onset and development of the disease.~      The confocal endomicroscopy is an endoscopic technique which can be performed during a~     bronchoscopy. This technique makes it possible to observe in real time the most distal~     pulmonary elements at the microscopic scale. After injection of fluorescein, then the~     technique of observing the pulmonary microvasculature, in vivo and in situ.~      The characterization of microvascular lesions in these two pathologies could improve~     understanding of their mechanisms and ultimately improve the early management of patients.~   "
38228|NCT02556684|"~     A prospective cohort study design will be conducted. Patients with LABC who receive~     chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline,~     midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited~     over a 2-year period. This study will give clinicians further insight into the usefulness of~     ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This~     could potentially lead to changes in clinical management of these patients.~   "
38229|NCT02556671|"~     Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long~     been the cornerstone in patients undergoing percutaneous coronary intervention (PCI).~     However, inhibition of platelet activation and aggregation after DAPT varies greatly among~     patients. Some clinical studies have demonstrated that patients with high on-treatment~     platelet reactivity are at increased risk of major adverse cardiovascular events. Tailored~     antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting~     by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major~     prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are~     neutral. In these studies, platelet function was only assessed by a single measurement and a~     single method early after the start of antiplatelet treatment. To test the stability of~     platelet reactivity measurements over time among patients undergoing PCI, investigators use~     3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status~     of VASP, light transmittance aggregometry) for platelet function testing in 2 periods~     (~14days), with maintenance doses of clopidogrel.~   "
38230|NCT02556658|"~     The purpose of this study is to evaluate if prediction of general anaesthesia level by the~     Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip~     fracture surgery.~   "
38231|NCT02556645|"~     The purpose of this randomized controlled trial is to compare the efficacy and potential~     biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE),~     Web-PE, delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT)~     delivered over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to~     170 individuals will be consented to obtain data from 120 for analysis. Participants will be~     assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment~     completion.~   "
38232|NCT02556632|"~     This randomized pilot phase II trial studies and compares prophylactic topical agents in~     reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or~     breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR~     Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss~     and inflammation during radiation therapy.~   "
38233|NCT02556619|"~     The purpose of this research study is to evaluate the effect of early palliative care~     consultation on quality of life, use of hospital resources, end-of-life care and survival~     among Hepatocellular Carcinoma (HCC) patients with advanced End Stage Live Disease not~     eligible for potentially curative or local area therapy. Half of patients will receive early~     palliative care at diagnosis of HCC and other half will receive palliative care when all~     standard therapy treatments have been exhausted.~   "
38234|NCT02556606|"~     The purpose of this study is to examine the effectiveness of a single infusion of ketamine~     (KET), to determine which dose is optimal and lasts the longest, and to learn about how~     ketamine works in the body and brain in persons with late-life treatment resistant~     depression.~   "
38235|NCT02556593|"~     This study is to assess the efficacy of IMRT combined with erlotinib compared with~     whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain~     metastases.~   "
38236|NCT02556580|"~     The study aims to determine the degree of plasma volume expansion and the half-life of the~     plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30~     minutes in conscious healthy volunteers, in patients undergoing surgery under general~     anesthesia, and on the day after major surgery when the patient is in a post surgical~     inflammatory state. The study also examines the increase in the plasma colloid osmotic~     pressure as a result of this infusion and its possible influence on markers of kidney~     damage.~   "
38237|NCT02556567|"~     This is a research study to find associations between asthma symptoms and sleep patterns and~     physical activity among adolescent patients with persistent asthma. The Investigators will~     collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.~   "
38238|NCT02556554|"~     A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating~     the role of continuous glucose monitor (CGM) use either alone or with remote monitoring~     capabilities during pregnancy associated with T1DM.~   "
38239|NCT02556541|"~     The purpose of this investigation is to conduct a randomized, patient-blinded prospective~     controlled trial comparing peripheral intravenous cannulation in children done by:~        1. Conventional landmark cannulation where the intravenous cannulation is done by direct~          visual guidance or palpation or a combination thereof.~        2. Ultrasound guided cannulation by means of DNTP.~      The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation~     the first-attempt success rate will be significantly higher than by the conventional~     landmark cannulation technique.~   "
38240|NCT02556528|"~     This is a study to assess the feasibility of using health coaching sessions in cancer~     patients. The investigators are investigating whether health coaching sessions can be~     delivered to this group of participants in a semi structured way. The investigators hope~     that the study will allow us to see whether such sessions can be delivered in a timely~     manner that is acceptable to patients and staff. The longer term aim for this work, should~     it prove feasible, is to conduct a randomised controlled trial to assess health coaching.~      The participants for the study will be selected using purposive sampling. The investigators~     will select a sample of 10 patients. The participants will be patients at the Oxford~     University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will~     include male and female patients and try to cover a range of ages from 18 upwards. It will~     cover patients taking a range of oral anticancer agents, for a range of different cancer~     indications. The sample will look at patients who are newly prescribed oral anticancer~     therapy through to patients who have been taking therapy for years.~      Participants will be identified for the study by multidisciplinary staff members who are~     running oral education sessions or by non-medical prescribers who are seeing patients in~     clinic. These members of the MDT will be given lists of the types of participants the~     investigators are looking for in the study and where appropriate offer patients the~     opportunity to take part. Patients will be contacted prior to the end of their subsequent~     cycle of treatment about whether they wish to participate. Patients wishing to take part~     will be consented at their next clinic visit.~      All participants will attend for their usual clinic visits throughout the study.~     Participants will additionally be offered up to 3 health coaching sessions for a maximum of~     three cycles or until treatment with their oral anticancer agent ends, whichever comes~     first.~      At the end of study visit participants will be asked to attend a qualitative based interview~     to discuss the intervention.~   "
38241|NCT02556515|"~     Interpositional arthroplasty is by many considered to be the current gold standard for the~     treatment of thumb carpometacarpal arthritis. The results are generally good, but the~     rehabilitation time can be long and failures are difficult to treat. Total joint~     replacements now exist with modern uncemented designs that can be an alternative treatment.~     Short term studies show that thumb function often is better and rehabilitation time shorter,~     however there is uncertainty with regards to the longevity of the implants. Currently no~     prospective randomized trials have compared these two treatment options. Our hypothesis is~     that the total joint replacement will give the same results or better when compared to the~     interpositional arthroplasty.~   "
38246|NCT02556450|"~     Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has~     developed. Prevention is most efficient when directed toward patients at risk and when~     mechanistically targeted to patients most likely to respond. An increase in myocardial and~     possibly vascular collagen content (fibrosis) may be a major determinant of the transition~     to HF. In patients with hypertension and diabetes, two important risk-factors for HF,~     changes in blood markers of fibrosis occur before clinically overt HF develops. These~     markers are also related to prognosis.~      In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated~     with cardiovascular (CV) risk factors, and predicts development of HF. In animal models,~     Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.~      The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA),~     spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in~     patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio~     of spironolactone might be superior in patients with a higher compared to lower plasma~     concentrations of Gal-3.~      Main objective is to investigate whether spironolactone can favourably alter extra-cellular~     matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III~     N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and~     whether this effect is greater in patients with increased plasma concentrations of Gal-3.~   "
38247|NCT02556437|"~     The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin~     10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment~     in patients with Multifocal Motor Neuropathy (MMN).~   "
38248|NCT02556424|"~     Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the~     therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only~     triamcinolone acetonide was available to ophthalmologists. This molecule, developed~     initially for rheumatological or dermatological use, has been increasingly deployed in~     ophthalmology, while still off-label.~      In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into~     the vitreous cavity obtained the label for inflammatory macular edema. This protocol is~     therefore designed to compare the efficacy and safety of peri- and intra-ocular injections~     of corticosteroids in the treatment of inflammatory macular edema.~   "
38249|NCT02556411|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment~     levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone~     (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried.~     The aim of this study is to compare the efficacy and usefulness of association of oral~     contraceptive pill and LNG-IUS or LNG-IUS alone~   "
38250|NCT02556398|"~     The project involve evaluation of a web-based nutrition education program and pilot-testing~     of a new smartphone app for real-time data logging to identify factors causing glycemic~     variability.~   "
38251|NCT02556385|"~     The aim of this study is to assess the safety and clinical efficacy of high or low-frequency~     repetitive transcranial magnetic stimulation based on brain activation with functional near~     infrared spectroscopy in poststroke nonfluent aphasia patients.~   "
38252|NCT02556372|"~     This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects~     with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper~     limit of normal (ULN) and who have had a failed response to, incomplete response to,~     intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The~     dose of JKB-122 will be escalated monthly.~   "
38253|NCT02556359|"~     The molecular mechanisms participating in the various aspects of the DNA Damage Response~     (DDR) are absolutely essential to maintain the genome dynamics essential to all living~     organisms. The most commonly studied consequence of faulty DDR is genome instability~     participating in cancer onset. In the present proposal, we wish to explore another aspect of~     DDR, not relevant to cancer, which is its absolute requirement at several key steps of the~     development, maturation, and function of the immune system.~      The most spectacular consequences of faulty DNA repair processes with respect to the~     immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing~     to defective DNA joining phase during V(D)J recombination resulting in patients with Severe~     Combined Immune Deficiency (SCID).~      The objectives of this study are to increase our knowledge on the role of the various DNA~     repair processes in the development, the maintenance, and the function of the immune system~     and thus, to better understand why and how dysfunctions of these DNA repair processes result~     in human severe conditions such as CVID, LOCID or other manifestations of immune disorders~     such as autoimmunity.~      The explorations of DNA repair mechanisms in the patients will allow us to establish the~     genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of~     immediate importance for the patients and their families, as it not only contributes to a~     better understanding of the patients' condition, but also allows providing genetic~     counseling for the families.~   "
38254|NCT02556346|"~     This Phase I, multiple ascending dose study will seek to enroll subjects with~     relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma~     (SLL) with confirmed and measurable disease who have received standard treatment with at~     least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen~     that resulted in initial response, followed by relapse/recurrence and who are not eligible~     for any further approved biologic therapy, chemotherapy and/or autologous stem~     transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve~     clinical benefit from any therapy of higher priority by Investigator assessment.~   "
38306|NCT02555657|"~     In this study, participants with metastatic triple negative breast cancer (mTNBC) will be~     randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy~     chosen by the treating physician (TPC) in accordance with local regulations and guidelines,~     consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study~     hypothesis is that pembrolizumab extends progression free and/or overall survival compared~     to TPC~   "
39975|NCT02533739|"~     The purpose of these studies is to determine whether vestibular disorders could affect~     visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire~     and a new computerized test using a digital tablet in different studies.~   "
38255|NCT02556333|"~     Background:~      HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used~     for treating HIV infection. For some people, ART drugs stop working against their HIV.~     Researchers want to see if a different form of the drug tenofovir (an ART drug currently~     approved by the FDA), combined with another drug, may help people whose HIV is resistant to~     ART. This combination pill is called F/TAF~      Objective:~      To study the safety and efficacy of the drug F/TAF, when used with other ART, for people~     whose HIV infection has been hard to control with available medicines.~      Eligibility:~      People age 14 years and older who have HIV infection and are enrolled in the DOTCOM~     (14-I-0009) protocol.~      Design:~      Participants will be screened with physical exam, medical history, and blood and urine~     tests.~      Participants will stay in the hospital for at least 10 days. For the first 9 days, they will~     take F/TAF by mouth along with their usual ART drugs.~      In the hospital, they will repeat the screening tests.~      Participants will have a DEXA scan, an x-ray that measures calcium and other minerals in the~     bones. Participants will lie on a soft table while the scanner passes over the lower spine~     and hips.~      Participants will get a supply of F/TAF and some new ART drugs to take at home.~      Participants will have follow-up visits in 1, 2, 4, 8, and 12 weeks. After the 12-week~     visit, they will come back about every 3 months for about 1 year.~      At these visits, participants will repeat the screening tests. They will discuss any~     problems taking their ART drugs. They may have another DEXA scan.~   "
38256|NCT02556320|"~     A recent study has shown that certain drug allergies were actually related to an immune~     system against certain viruses. The aim of the study is to evaluate, in patients taking~     antiepileptic drugs, if this treatment induces proliferation of these viruses and~     secondarily an immune response that would promote the development of a rash. In particular,~     will be studied whether these drugs can induce virus reactivation dormant in the immune~     system. This study will not affect the usual follow-up proposed by investigators, with the~     exception of some additional blood samples.~   "
38257|NCT02556307|"~     In this Slovenian, multi-center, observational study, the effectiveness of standard of care~     Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC)~     is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating~     physician, followed by a 24-week follow-up period.~   "
38258|NCT02556294|"~     India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an~     identified high risk group. MSM in India face unique psychosocial stress underlying the~     context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the~     purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a~     behavioral intervention that addresses both psychosocial / contextual stress and reducing~     participant's risk for HIV.~   "
38259|NCT02556281|"~     After curative surgical resection, detection of metastatic lymph node remains the main~     prognostic validated criteria on which is based the decision of adjuvant therapy. To date,~     none of the molecular alterations, identified as potentially predictive factor, are used in~     routine for therapeutic decision. The circulating markers, either in the form of free~     circulating DNA or in the form of circulating tumoral cells seems important potential~     candidates. To investigators knowledge, only one study estimated with several interesting~     results the prognostic interest of a coupled detection of the free circulating mutant DNA~     (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain~     however difficult to achieve because of the small number of patient included (n=58) and the~     fact that this study included different stages. For colorectal cancer a Chinese team~     presented a series of results suggesting that the presence of CTC during the postoperative~     course is a factor significantly related to the risk of recurrence. In multivariate analysis~     integrating the lymph node status and the vascular invasion, the presence of CTC appeared as~     an independent factor for recurrence with a hazard ratio of 29.5.~      The aim of the present study is to compare the prognostic value of two circulating tumoral~     markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating~     tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two~     circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival~     rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA~     and circulating tumoral cells in localised colorectal cancer.~   "
38260|NCT02556268|"~     To investigate the pharmacokinetic drug-drug interaction potential of fixed dose~     antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved~     antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure~     to riociguat in HIV patients on a stable dose of one of these therapies.~      • To Assess the safety and tolerability of riociguat treatment in combination with these~     fixed-dose antiretroviral therapies.~   "
38261|NCT02556255|"~     The aim of the study is to assess the safety and efficacy of the use of the Eximo's CathiTM~     hybrid catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity~     arteries.~   "
38262|NCT02556242|"~     Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about~     5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy~     has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic~     districts. As recent case data indicate that the levels of transmission in many districts~     have been reduced to very low levels, the continuation of untargeted IRS in areas where~     there is little or no evidence of recent transmission may be unwarranted. Efforts to~     eliminate malaria will only be sustainable if mass prevention efforts can be scaled down in~     an evidence-based manner, whilst maintaining or enhancing high sensitivity of the~     surveillance system of the disease. This trial will provide scientific evidence for targeted~     malaria prevention responding to localised transmission in pre-elimination settings,~     compared to continuation of generalised IRS of all houses.~      Two methods of IRS delivery for community malaria prevention will be compared through an~     open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of~     approximately 8,000 inhabitants per cluster.~      Comparison is on the basis of non-inferiority by showing that malaria incidence in the~     targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a~     specified margin of difference, and on the basis of superiority showing that the proportion~     of houses targeted for spraying is higher in the intervention than the reference arm.~     Neighbourhood investigation in response to two cases in the intervention arm, and comparison~     neighbourhoods in the reference arm, will include testing for antibody sero-conversion to~     malarial antigens to assess whether cases arise in communities with long term exposure to~     malaria parasites.~      The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in~     localities which have average reported incidence of malaria of <5 cases per 1000 per annum~     over the past five years.~   "
38336|NCT02555254|"~     Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow~     rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a~     period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm~     and successfully resuscitated.~   "
38263|NCT02556229|"~     Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and~     Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment~     should not be delayed.~      InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)~     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated~     in AMD. Case reports suggest that such patients would not need as many injections as in AMD.~      ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage~     regimen is designed to achieve maximum efficiency. The patients are followed on a monthly~     basis until 52 weeks. The first injection is mandatory. The other ones are injected only in~     case of active InCNV.~   "
38264|NCT02556216|"~     Bone and mineral disease is a key problem in patients with kidney disease. The available~     clinical parameters are non-specific, unproven for the assessment of the bone metabolism and~     do not reflect the complexity and diversity of the underlying bone pathology. The aim of~     this study is to use bone histology, novel bone markers and bone imaging results to~     establish a reliable decision model (diagnostic tool) that can be used to guide the~     individual therapy.~   "
38265|NCT02556203|"~     To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR,~     compared to an antiplatelet-based strategy, is superior in reducing death or first~     thromboembolic events (DTE).~      To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an~     antiplateletbased strategy, following TAVR.~   "
38266|NCT02556190|"~     The emergence of multidrug-resistant bacteria has recently renewed interest in colistin.~     Data on dosing in critically ill patients undergoing extended dialysis are missing. The aim~     of this study is to determine the pharmacokinetics of colistin during extended dialysis in~     critically ill patients and to provide dosing guidelines for this drug.~   "
38267|NCT02556177|"~     This is an open-label, non-randomized, prospective, multi-site, parallel group (segment),~     hypothesis-generating study designed to collect data that will aid in future scientific and~     engineering exploration of correlations between clinical neuropsychological assessments and~     GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended~     for scientific inquiry and engineering development purposes, and may be used in future~     regulatory submissions.~   "
38268|NCT02556164|"~     Gait and balance disorders, key contributors to fall and poor quality of life, represent a~     major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of~     acupuncture in recent years in PD, its efficacy remains unclear, largely due to~     methodological flaws and lack of high quality studies using objective outcome measures. In a~     patient and assessor-blind pilot study, investigators objectively assess the efficacy of~     electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in~     patients with PD.~   "
38269|NCT02556151|"~     Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and~     elderly, and 45% of nursing home residents. It significantly impairs quality of life and~     poses a major health care burden. FI is characterized by significant neuromuscular~     dysfunction of the pelvic floor that includes bilateral lumbo-anorectal and sacro-anorectal~     neuropathy and sensori-motor dysfunction. This multifactorial etiology suggests that~     maladaptive neuroplastic changes in the neural innervation of lower gastrointestinal tract~     could play a significant role in the pathogenesis of FI. A critical barrier to progress in~     the treatment of FI is the lack of understanding of how treatments affect the core~     pathophysiological mechanisms of FI, and the absence of mechanistically based non-invasive~     therapies. Our goal is to address the problem of FI by developing therapies that modulate~     peripheral and central neuronal perturbations and thereby improve visceromotor control and~     sensori-motor dysfunctions, and to understand the neurobiologic basis of these treatments.~     Our central hypothesis is that a novel non-invasive treatment consisting of repetitive~     translumbar magnetic stimulation (rTLMS) and repetitive transsacral magnetic stimulation~     (rTSMS) will significantly improve FI by enhancing peripheral and central neural~     excitability and will provide a multidimensional therapeutic benefit- enhance anal muscle~     strength, improve stool perception and improve rectal capacity. Our approach is based on our~     preliminary studies which suggest that repetitive translumbar magnetic stimulation (rTLMS)~     and transsacral magnetic stimulation (rTSMS) improve anorectal pain and neuropathy and~     induce central neuroplastic changes.~      Our objectives are to:~        1. address the significant gap in our knowledge regarding the peripheral and central~          neuroenteric axis and how perturbations in the afferent and efferent neural signaling~          can affect FI;~        2. develop a new treatment for FI with repetitive magnetic stimulation and determine the~          feasibility, safety and optimal frequency setting of rTLMS and rTSMS;~        3. determine the mechanistic basis for this neuromodulation therapy;~        4. identify if the locus for improvement lies in the afferent or efferent signaling or~          both.~   "
38270|NCT02556138|"~     The purpose of this study is to determine whether the ORBERA Intragastric Balloon is a safe~     and effective means for weight loss and improved metabolic disease in patients with~     cirrhosis requiring liver transplantation.~   "
38271|NCT02556125|"~     Respiratory dysfunction is the leading cause of death in individuals with spinal cord~     injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord~     segments which impairs neural activation of the diaphragm muscle and compromises breathing.~     Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also~     triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even~     preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing,~     was developed to replace long-term ventilator support, and is now used acutely post C-SCI~     (<4 months following injury) to promote ventilator weaning. The impact of diaphragm pacing~     on respiratory function and diaphragm muscle activation has not been formally evaluated.~     This is an essential step in determining the efficacy of intramuscular diaphragm stimulation~     and its effects on respiratory function after SCI. Accordingly, this research study will~     evaluate the effects of intramuscular diaphragm stimulation and test the hypothesis that~     diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in~     adults with cervical SCIs. The investigators will test the hypothesis by evaluating the~     effects of diaphragm pacing on neuromuscular activation of the diaphragm by directly~     recording electromyogram (EMG) activity from the intramuscular pacing electrodes. Recording~     from these surgically-implanted electrodes allows direct comparisons of EMG activity across~     time, minimizing methodological limitations inherent with surface or percutaneous EMG~     recordings. This approach, in association with respiratory assessments, will be used to~     investigate the impact of diaphragm pacing in adults with intramuscular diaphragm pacing~     electrodes following acute, traumatic C-SCIs.~   "
38307|NCT02555644|"~     The main purpose of this study is to investigate the safety of prexasertib in combination~     with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants~     with locally advanced head and neck cancer. The study has two parts (A and B). Participants~     will only enroll in one part. Participants in the United States may enroll in either Part A~     or Part B. Participants in France may only be enrolled in Part A.~   "
38272|NCT02556112|"~     With this study researchers will evaluate the effects of the GLB intervention on weight~     loss, chronic disease indicators and self-perceived function and well-being in an active~     duty population. The purpose of this study is to examine the effectiveness of the GLB~     program [compared with two currently available programs, the Fitness Improvement Program~     (FIP) and the Better Body Better Life (BBBL) program], on the following health indicators:~     improvement of individual physical fitness as measured by change in abdominal circumference,~     weight and physical activity; decrease in risk associated with chronic disease as measured~     by changes in lipid and HbA1c levels; and improvement in self-perceived function and~     well-being as measured by the RAND 36 Item Short Form Health Survey (RAND SF- 36). In~     addition, the researchers seek to obtain feedback about the programs from the participants.~   "
38273|NCT02556099|"~     The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label~     hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell~     Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial~     Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but~     treatment will continue until a common study termination date.~   "
38274|NCT02556086|"~     The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and~     sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated~     previously without liver cirrhosis who are chronically infected with hepatitis C virus~     (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.~   "
38275|NCT02556073|"~     Poor adherence to asthma controller medication may link to poor asthma outcome. A metered~     dose device with built-in dose counter helps physicians to monitor drug compliance in asthma~     patients. Mobile-phone based self management opens a window for better asthma control. The~     present study aims to investigate the relationship between the adherence to controller~     medication of combined inhaled corticosteroid/long acting beta2-agonists, assessing by~     integrated dose counter, and the level of airway inflammation and asthma control. Moreover,~     the investigators also use a new asthma self-management Apps to enhance drug compliance.~     With the application of the new, easily available tools, the investigator expect to increase~     adherence rates, and hence, to reduce airway inflammation and improve the level of asthma~     control.~   "
38276|NCT02556060|"~     The purpose of this study is to investigate the efficacy of lamotrigine in the treatment of~     ketamine dependence in a double-blind, placebo controlled design.~   "
38277|NCT02556047|"~     Several vaccinations are administered by the intradermal (ID) method where the vaccine is~     injected between layers of skin. The current technique required to do this can be difficult~     to learn and perform accurately, is slower to deliver than subcutaneous or intramuscular~     injections, and there is a risk that the injection will be given to too-deep skin layers or~     to underlying tissues, which might change the immune response. There is increasing interest~     in using ID administration for vaccines as it may be possible to achieve the same immune~     response with a smaller dose of vaccine. This could increase access to vaccines that are~     expensive or are only available in small quantities and therefore could have global health~     benefit for vaccine programs for diseases such as yellow fever and polio.~      Because of the potential global-health benefits of being able to give ID injections of~     vaccines easily, quickly and with relatively little training or experience, several novel~     devices are currently being developed to allow easy ID administration. Star Syringe have~     developed two novel intradermal safety devices that differ only in the length of the needle~     used. The current study will assess how the two new devices perform, compared to the~     traditional Mantoux test, using injections of saline into the upper arm. Twenty volunteers~     (18-60 years, male and female) will be recruited and attend a screening visit (1), an~     injection visit (2a) and have a follow up telephone call (2b). At the injection visit they~     will receive 3 injections in each arm (Mantoux and 2 device injections) and measurements~     will be performed.~      A subset of volunteers will be invited back to attend an additional visit (3a) which will be~     a repeat of visit 2 but with an ultrasound image taken of each injection site. There will be~     a follow up telephone call 24 hours later (3b).~   "
38278|NCT02556034|"~     This study will establish a comparison in follow-up care of 100 patients between Health Care~     Practitioners, more specifically the rheumatologist and a trained nurse. The study objective~     is to show consistency of evaluation between two different health care professionals, a~     physician and a nurse.~   "
38279|NCT02556021|"~     The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once~     daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4~   "
38280|NCT02556008|"~     This is an open-label observational study of pure CBD for the treatment for 25 children with~     intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this~     study via the FDA expanded access mechanism on a compassionate use basis. The target patient~     population is children with severe refractory epilepsy who have exhausted all other~     reasonable avenues of treatment. These are patients for whom the risks of a relatively~     untested product are outweighed by the potential benefit. Using seizure-diaries maintained~     on a routine clinical basis, seizure frequency will be assessed four weeks prior to~     initiation of CBD, one month after CBD initiation, and at least every 3 months thereafter.~     CBD will be administered as an adjunct to all current anti-epileptic therapies.~   "
38281|NCT02555995|"~     Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique~     ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular~     degeneration (AMD).~      This study assesses the scanning performance of a newly developed sparse OCT retina scanner~     that is smaller and more compact than most commercially available medical OCT systems. The~     prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.~      In this study the device is first tested on human eyes. The scanning performance is compared~     to a reference device. Additionally patient feedback during the examination is acquired.~      The findings of this study are used to improve the software and the ergonomics of the~     investigational device.~   "
38308|NCT02555631|"~     The purpose of this two-year proposal is to:~        1. develop and~        2. complete a pilot test of an adaptation of the evidence-based National Diabetes~          Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged~          communities in New York City.~      The sites for this pilot study are New York City Parks and recreation centers. Study's main~     outcome is weight loss of 5-7% baseline weight.~   "
38309|NCT02555618|"~     The purpose of this study is to evaluate the immunogenicity and safety of TAK-850~     administered subcutaneously as a single dose versus influenza HA vaccination in an~     exploratory manner.~   "
38310|NCT02555605|"~     This study aimed to determine the feasibility of dexmedetomidine in children with~     respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI)~     scans.~   "
38282|NCT02555982|"~     Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or~     primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis~     intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of~     blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses,~     leading to a reduction of pathological muscle movement. Very little information is available~     on its efficacy on HT. Two published reports suggested that local Btx A injections could be~     an effective and safe approach for treating HT. Given the scarcity of published data (small~     samples, open studies, different doses of Btx used, heterogeneous populations, several~     muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx~     injections in essential HT by a multi-center, randomized, double-blind, parallel-group,~     placebo-controlled study.~      Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment~     of head tremor.~      Secondary objectives:~        -  - To evaluate the tolerance of botulinum toxin injections in the treatment of head~          tremor.~        -  - To evaluate the impact of botulinum toxin injections on the patients' quality of life~          and embarrassment.~        -  To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D~          accelerometer wireless portable system (Xsens MTw wireless motion tracker system)~          (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a~          new video system device to analyze head tremor characteristics~   "
38283|NCT02555969|"~     This protocol will assess patients with AL amyloidosis who achieve a complete response (CR)~     or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three~     approaches to MRD testing will be used since there is no established method. The~     investigators will clone and sequence each patient's light chain (LC) gene and design~     patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome~     sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy~     number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11~     and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use.~     Plasma protein analysis by mass spectrometry will also be used to look for fragmentary~     protein sequences associated with the culprit LC gene of each subject. The feasibility and~     predictive value of these three approaches in patients achieving CR or VGPR will be~     evaluated. This protocol will help provide insight into the ways that the disease changes~     and progresses. MRD testing is likely an important next step in AL management.~   "
38284|NCT02555956|"~     Diabetic related complications are increasing day by day due to increse in the number of~     diabetic patients all over the world. Diabetic macular edema is one of them and a major~     cause of vision imparment. Various kind of treatment modalities are preent to treat this~     coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive~     procedure.Laser power if kept to aminimum can get the desired results without severe~     destruction to the retina . In this study, the investigators are going to document the~     effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.~   "
38285|NCT02555943|"~     This is a prospective study to determine the incidence, morbidity, mortality and~     predisposing factors for the reactivation of hepatitis B virus replication during direct~     anti-HCV treatment of HCV/HBV co-infection patients.~   "
38286|NCT02555930|"~     HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection,~     affecting between 20 and 57% of infected individuals. The advent of better antiretroviral~     treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK.~     This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN~     and cognitive impairment, are increasing in prevalence and becoming a significant disease~     burden.~      The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is~     known about the genetic basis of the disorder and what risk factors mean that some patients~     with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further~     characterising or 'phenotyping' the disorder, it will be easier to identify which patients~     are at risk of developing neuropathy and chronic pain. It may also mean that treatment can~     be more individualised as currently patients often undergo a frustrating 'trial and error'~     protocol of treatment, as clinicians can not yet predict who will respond to which~     treatment.~      It has also been suggested that there is a link between HIV-SN and HIV associated~     neurocognitive disorder (HAND), which is another common, age-related complication of HIV~     infection. It may be that the existence of one pathology could predict the development of~     the other, or that the presence of HAND may impair the diagnosis or treatment of chronic~     pain associated with HIV-SN.~      This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify~     genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to~     more deeply phenotype the condition, using well validated questionnaires, and to identify~     any influence that early neurocognitive dysfunction may have on the reporting, diagnosis and~     treatment of neuropathic pain in the HIV population.~   "
38287|NCT02555917|"~     Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate~     ligament complete rupture leads to knee joint instability and degenerative change of the~     knee. Anterior cruciate ligament reconstruction is performed for resolving these problems~     and it gives excellent results. For leading to successful result of anterior cruciate~     ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is~     necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis,~     impingement of transplanted tendon, loss of range of motion, instability, failure of~     transplantation and risk of arthritis. It is known that selection of inappropriate tibial~     tunnel location is the most common cause of anterior cruciate ligament reconstruction~     failure.~      Recently many studies reconstructed at anatomical lesion instead of isometric point. And~     some cadaver studies reported that tibial insertion of anterior cruciate ligament has C~     shape. There are two methods for anterior cruciate ligament reconstruction. One is~     preserving remnant and the other is removing remnant.~      This study aims to compare the tibia and femoral tunnel location of remnant preserving and~     remnant resecting anterior cruciate ligament reconstruction.~   "
38288|NCT02555904|"~     This is an observational, single center study to evaluate if acoustic and~     accelerometer-based measures of voice and speech have sufficient precision to detect a~     change in lung fluid status for patients with confirmed acute heart failure syndrome with~     pulmonary congestion. The study shall be conducted in concordance with the United States FDA~     regulations for a non-significant risk study. Patients admitted for acute heart failure~     syndrome with pulmonary congestion with an expected stay greater than 3 to 4 days, who are~     willing and able to sign an informed consent, and who meet all inclusion/exclusion criteria,~     as identified by the clinical investigator, will be enrolled in the study. Results of this~     study will evaluate the sensitivity of voice and speech measures in detecting changes in~     lung fluid status in a symptomatic population. Up to 12 subjects will be enrolled to~     comparatively evaluate the voice outcome measures in this pilot study.~   "
38289|NCT02555891|"~     The overall objective of the present study will be to describe the occurrence of Potentially~     Inappropriate Prescribing (PIP) in Ontario's elderly (>65 yrs) population, assess the health~     and economic burden associated with it, and evaluate interventions aimed at mitigating its~     effects.~      To attain this objective, the investigators will test three specific hypotheses:~      Hypothesis 1: Instances of Potentially Inappropriate Prescribing are frequent and costly. To~     test this hypothesis, the investigators will apply a subset of the STOPP criteria and Beers~     criteria to Ontario health administrative data to identify instances of potentially~     inappropriate prescribing, and estimate potential savings, both direct and indirect, that~     could be achieved by reducing inappropriate prescribing.~      Hypothesis 2: ED visits and hospitalizations are significantly associated with Potentially~     Inappropriate Prescribing. To test this hypothesis, the investigators will estimate the~     attributable fraction of ER visits and hospitalizations associated with different~     frequencies of PIP using multivariate methods and survival analysis.~      Hypothesis 3: The likelihood of inappropriate prescribing is associated with patient and~     physician characteristics. To test this hypothesis, the investigators will identify each~     physician's annual PIP incidence density, calculated by dividing the number of PIP they~     issued by the total number of prescriptions they provided over the study period and then~     explore the association of patient and physician level covariates with patient outcomes.~      The investigators will test these hypotheses in the framework of a retrospective cohort~     study which the investigators will conduct using Ontario's large health administrative and~     population databases. These are housed at the Institute for Clinical Evaluative Sciences~     (ICES) and contain information on both hospital and outpatient use of health services, as~     well as demographic and socioeconomic data. Patients included in the study will be all OHIP~     (Ontario Health Insurance Plan) eligible patients aged 66 yrs of age and older who have been~     issued at least one prescription between April 1st 2003 and March 31st 2013.~      The investigator team, housed at ICES@uOttawa, has extensive experience and expertise with~     the analysis of these databases, and has the support and resources necessary to successfully~     carry out this study.~   "
38290|NCT02555878|"~     The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for~     reducing the risk of the primary composite outcome as defined by objectively confirmed~     symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower~     extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary~     embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory~     adult participants with various cancer types receiving systemic cancer therapy who are at~     high risk of developing a VTE.~   "
38291|NCT02555865|"~     This multicenter retrospective observation study is designed to investigate the etiology of~     children with bronchiectasis by review the medical records.~   "
38292|NCT02555852|"~     The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication~     used to treat gastric conditions, increase the risk of hospitalization for~     community-acquired pneumonia (HCAP).~      The investigators will carry out separate population-based cohort studies using~     administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort~     entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug,~     with follow-up until hospitalization for pneumonia or end of follow-up (6 months). The~     results from the separate sites will be combined using a statistical approach called~     meta-analysis to provide an overall assessment of the risk of HCAP with PPIs.~   "
38293|NCT02555839|"~     There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously~     treated with Lenalidomide and Bortezomib, due to poor prognosis.~      This observational study focuses on the collection of data concerning the safe and optimal~     usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the~     knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage~     and efficacy will be performed.~      This knowledge could lead to a optimization of Pomalidomide usage and treatment.~   "
38294|NCT02555826|"~     A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy~     and Safety of Apremilast (CC-10004), in Subjects with Moderate Plaque Psoriasis~   "
38295|NCT02555813|"~     This observational program collects data on tolerability, safety and efficacy regarding the~     use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine.~     Additionally data on dosage that is actually used in these patients will be collected.~     Patients who have pancreatic cancer and additional diseases can be documented in this study,~     too. Collected data might generate learnings on the optimal use of Abraxane in the daily~     routine setting.~   "
38296|NCT02555800|"~     The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal~     antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in~     patients with recurrent respiratory papillomatosis.~   "
38297|NCT02555787|"~     A study to evaluate changes over time in renal function from baseline (time of conversion)~     up until five years post conversion in kidney transplant patients converted from tacrolimus~     twice daily (BD) formulations to a once daily formulation as Advagraf.~   "
38298|NCT02555774|"~     This study evaluates the efficacy of cognitive training in subjects with subjective memory~     impairment. The first group will receive cognitive training and lifestyle modification in~     combination, the second group will receive only lifestyle modification, and the third group~     will receive no intervention.~   "
38299|NCT02555761|"~     This post-marketing surveillance study will assess the safety and efficacy of Lastacaft®~     Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with~     Allergic Conjunctivitis as prescribed as standard of care in clinical practice in Korea.~   "
38300|NCT02555748|"~     This pilot study is an open-label interventional study, prospective, non-comparative,~     sequential (two stages), national, multicenter study.~      Patients starting therapy with sunitinib or pazopanib as standard first line treatment for~     advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts~     (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).~      The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose~     individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of~     this approach in terms of tolerance and efficacy compared with the current empirical method~     based only on tolerance observation.~   "
38301|NCT02555735|"~     This is an observational study enrolling patients with metastatic pancreatic cancer to~     identify genomic differences between exceptional responder and non-responders to standard of~     care chemotherapy. Data analysis of the gene expression profile of the exceptional~     responders compared to non-responders will define genomic patterns that may help understand~     their response to chemotherapy.~   "
38302|NCT02555709|"~     This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742~     will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic~     patients, both in sequential ascending dose panels.~   "
38303|NCT02555696|"~     This observational project is collecting tolerability, safety and efficacy data with the~     routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on~     the dosage of Abraxane and general data on the disease and the health status of the patient~     will be collected.~   "
38312|NCT02555579|"~     This is a study to determine if a simplified protein counting system, including the free~     usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in~     teens and adults with phenylketonuria (PKU).~      Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to~     participate in this study.~      Subjects will be educated on the simplified system upon enrollment, and historical~     phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about~     their attitudes towards their current Phe counting system.~   "
38313|NCT02555566|"~     Endothelial lesions within the transplanted kidney are a major determinant of chronic~     allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived~     hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator~     properties.~      The main goal of the investigators' study is to evaluate whether genetic polymorphisms of~     specific enzymes responsible for the bioavailability of EETs are associated with~     post-transplant kidney function.~      To this end, 80 kidney transplant recipients will be included. Prespecified genetic~     polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined.~     Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated~     dilatation, EETs and circulating biomarkers of endothelial function will be measured in the~     radial artery.~      The expected results of this study to provide preliminary evidence supporting a beneficial~     role of an increase in the bioavailability of EETs in kidney transplant recipients.~   "
38314|NCT02555553|"~     The purpose of the proposed Phase II STTR study is to test the primary efficacy of a novel~     mobile app, 'Noom Monitor,' in a large population of binge eaters in the Kaiser Permanente~     health care system relative to a well-established treatment as usual (TAU) control~     condition. Noom Monitor facilitates the delivery of CBT-GSH by utilizing a patient interface~     that increases adherence and provides between-session reminders of CBT-GSH principles. In~     addition, the Noom Monitor includes a therapist interface with weekly feedback to the~     provider about patient progress. This application has several primary objectives, including:~     (1) testing the real-world effectiveness of the Noom Monitor in a clinical setting, and (2)~     establishing a database of training materials for Noom Monitor. The knowledge gained from~     the current study will contribute to our understanding of the role of new emerging mobile~     technologies in augmenting existing treatments.~   "
38315|NCT02555540|"~     The purpose of this protocol is to generate a set of data that will be analysed by~     integrated systems biology approach, for validation in subsequent clinical trials or in~     animal models.~      240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of~     Boostrix on Day 0, 20 will receive a placebo on Day 0.~   "
38316|NCT02555527|"~     To perform a cost-effectiveness analysis for the routine use of contrast in rest~     echocardiography in patients with dilated or ischemic cardiomyopathy from the United States~     healthcare system, provider and payer perspectives.~   "
38317|NCT02555514|"~     The association between varus malalignment and dynamic knee loading / adduction moment and~     progression of knee joint cartilage degeneration in the lateral compartment is unclear and~     has not been studied in detail before. There is a need to identify relevant parameters~     explaining this cause-effect relationship. It is the purpose of the study to correlate load~     changes in knee joints with biomechanical and biochemical alterations in cartilage to~     understand the underlying mechanism of load induced cartilage degeneration in patients. This~     study will therefore include patients with different stages of knee OA with various~     malalignments. Moreover, analyzing changes in cartilage morphology, radiography and MRI and~     correlate those findings with alterations in biochemical parameters in cartilage, serum,~     urine and synovial fluid will allow us to identify novel biomarkers for the onset and~     progression of joint cartilage degeneration in varus malaligned knees.~      The following hypotheses will be tested:~        1. Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned~          knees.~        2. External knee adduction moments in patients with isolated medial OA are higher when~          compared with patients with OA of the medial and lateral compartment.~        3. Morphological and mechanical properties of cartilage show different stages of~          degeneration when comparing the mechanically stronger loaded medial with the lateral~          compartment of the knee.~        4. Histological and biochemical analysis of the cartilage indicate different stages of~          degeneration when comparing the mechanically loaded medial with the lesser loaded~          lateral compartment of the knee.~        5. Synovial fluid analysis, as well as serum biomarkers of cartilage metabolism~          demonstrate cartilage degeneration and are related to biomechanical determinants of OA~          in the knee.~        6. Novel biomarkers (ECM, miRNA, cytokines, mitochondria related, mechanical determinants)~          for varus-aligned knees can be identified.~   "
38318|NCT02555501|"~     The aim of the study was to evaluate the therapeutic action through the diameter of the~     lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis~     (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was~     performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora~     Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT +~     LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own~     control. Patients were masked about therapy performed on each side of the arch. The~     evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the~     lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect~     magnitude calculated. The significance level was 5%. Statistically significant difference~     was observed between the groups for the lesion diameter of the 6th to the 8th day (greater~     regression of lesion size for the PDT + LLL group), which was confirmed by a difference~     magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater~     therapeutic effect when compared to LLL in reducing the severity of OM lesions.~   "
38319|NCT02555488|"~     The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and~     Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth~     with periradicular lesion.~   "
38320|NCT02555475|"~     The Prime Study is a randomised trial investigating models of care for hepatitis C in the~     era of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of~     hepatitis C care and DAA treatment provided in a primary health care service with a tertiary~     hospital.~   "
38321|NCT02555462|"~     Integration of the REM-verification within the fitting workflow will enable the hearing care~     professional to easily run real ear measurements. The purpose of the two study parts is to~     prove that an integrated cooperative system, consisting of fitting software and measurement~     system, matches desired responses for certain stimuli faster, more reliably and more~     precisely at the ear drums of hearing instrument wearers than current best practice~     processes.~   "
38322|NCT02555449|"~     The purpose of this study is to measure how much of the specially prepared study drug,~     LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it~     takes the body to get rid of it.~      Information about any side effects that may occur will also be collected.~      Participants will stay at a clinical research unit (CRU). The study will last about 28 days~     (check in to follow-up) for each participant.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
38323|NCT02555423|"~     The aim of the study is to determine the effectiveness of serratus place block in the~     control of post-operative pain following mastectomy. The investigators will compare one~     group of patients receiving serratus plane block and wound infiltration to a control group~     receiving a saline injection into serratus anterior and wound infiltration with local~     anaesthetic only. The investigators will compare our results to the National Mastectomy and~     Breast Reconstruction Audit's reported rate of 6.2% of patients reporting severe pain~     following mastectomy to see if there is an improvement of the national standard. In the~     serratus block group, the investigators expect a 50% decrease in the number of patients who~     report severe pain day one post operatively.~   "
38324|NCT02555410|"~     This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure~     detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.~   "
38325|NCT02555397|"~     The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and~     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene~     therapy in men with locally recurrent prostate cancer after definitive radiotherapy~   "
38326|NCT02555384|"~     Amblyopia, affects 4% of the population. In the presence of a normal retina and optic nerve,~     the visual cortex does not develop normally secondary to the amblyopic eye being at a~     disadvantage in the sensitive period such as in strabismus. Amblyopia is associated with~     visuospatial disorders, and poor to absent stereopsis. Amblyopia is treated by occlusion of~     the non- amblyopic eye in childhood. The present study aims to evaluate the effectiveness of~     perceptual learning (PL), that is a training of visual drawing tasks (12 sessions of 30~     Minutes duration) with crowding (c) for children with amblyopia compared to an amblyopic~     control group with a placebo drawing task.~      Arm 1: Crowded (PLc)- Training with small spacing Arm 2: Uncrowded (PLu)- Training with~     large spacing Prior to this, a small group will help optimize parameters such as contrast~     and distance of visual objects presented~   "
38327|NCT02555371|"~     Primary objective of the study is to evaluate whether patients with severe eosinophilic~     asthma who have received long-term treatment with mepolizumab (at least 3 years) need to~     maintain treatment with mepolizumab to continue to receive benefit. Subjects who~     participated in the open-label studies MEA115666 or 201312 with at least 6 months of~     treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed~     doses of mepolizumab treatment will be eligible to participate in this study. This study~     will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable~     Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the~     required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4~     weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab~     (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized~     double-blinded part. Upon completion of Part B, eligible subjects will be randomized to~     mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.~      Subjects discontinuing investigational product (IP) due to a clinically significant asthma~     exacerbation will then enter optional Part D of the study. During Part D, subjects receive~     open-label mepolizumab in addition to their standard of care therapy for the remainder of~     the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted~     52 weeks after randomization in order to assess subject's efficacy parameters,~     immunogenicity status, and to conduct additional safety assessments. Eligible subjects will~     participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0~     to 132 weeks) and Part B (4 to 8 weeks).~   "
38328|NCT02555358|"~     The purpose of this study is to assess the relationship of pCR rate and efficacy by~     comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric~     cancer patients.~   "
38329|NCT02555345|"~     This study aims to identify and validate the gene expression differentials of peripheral~     blood mononuclear cells and differential inflammation profiles and other aspects in classic~     asthma, cough-variant asthma and eosinophilic bronchitis.~   "
38330|NCT02555332|"~     This study was conducted to analyze the role of TSH level and TPOAb status in early~     pregnancy and use this information in assessment of the risk of gestational diabetes~     mellitus at different weeks of gestation when the FT4 level is normal.~   "
38331|NCT02555319|"~     The purpose of this study is to evaluate the safety and short-term effectiveness of~     implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart~     disease with pulmonary valve disease.~   "
38332|NCT02555306|"~     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and~     bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with~     refractory exudative age-related macular degeneration (AMD).~   "
38333|NCT02555293|"~     Surgery is in almost all cases the only potentially curative treatment option for patients~     with primary or secondary malignancies of the liver. However, in most cases oncological~     resections (R0-resections) can only be achieved by performing major liver resections (4 or~     more liver segments), which is related to considerable postoperative complications such as~     systemic infections and postoperative liver insufficiency (postresectional liver failure~     (PRLF)). Despite optimized preoperative and postoperative strategies of care presently, up~     to 32-55% of patients display severs postoperative complications (Clavien score ≥ 3a) and 5%~     even suffer from a severe PRLF. Recent observations in murine disease models as well as~     human patients suggested that postoperative alterations of hemodynamics within the portal~     vein tract as well as postoperative modulations of the immune response facilitates the~     translocation of gut bacteria in the blood, leading to systemic infections and sepsis.~     Moreover it became apparent that inflammatory mediators, released by the gut microbiota~     might negatively affect postoperative liver regeneration. Rifaximin (Xifaxan®) is a novel~     and potent, semisynthetic antibiotic that efficiently acts against most enteric bacteria and~     significantly reduced liver inflammation and liver fibrosis in animal studies. Moreover,~     Rifaximin is very well tolerated, even in patients with liver insufficiency.~   "
38334|NCT02555280|"~     A 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative~     spinal stenosis with concomitant low back pain by decompression with and without additional~     stabilization using the coflex® Interlaminar Technology for FDA Real Conditions of Use~     Study.~   "
38337|NCT02555241|"~     The purpose of this study is to investigate the effects of several applied behavior teaching~     procedures on the use of multi-word utterances by children with autism.~   "
38338|NCT02555228|"~     A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid~     simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given~     at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility~     score.~   "
38339|NCT02555215|"~     The primary objective of the study is to evaluate the long-term safety of BG00012 in~     subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To~     evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis~     (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).~   "
38340|NCT02555202|"~     The main objective of this study is to develop and to validate a French version of the~     London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the~     reliability of this version for the evaluation of the dyspnea in the Activity of Daily~     Living in COPD patients (stages severe and very severe).~   "
38341|NCT02555189|"~     This partially randomized phase IB/II trial studies the side effects and best dose of~     ribociclib when given with enzalutamide and to see how well they work compared to~     enzalutamide alone in treating patients with prostate cancer that does not respond to~     treatment with hormones (hormone resistant), has spread from the primary site (place where~     it started) to other places in the body (metastatic), is chemotherapy naïve, and retains~     retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells.~     Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of~     testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works~     better when given with or without ribociclib in treating patients with prostate cancer.~   "
38342|NCT02555176|"~     This pilot clinical trial studies the effects of a low carbohydrate diet on tumor metabolism~     in patients with head and neck cancer. A low carbohydrate diet may reduce the metabolic~     activity of cancer cells and of surrounding supportive tissues. Studying samples of tissue~     and blood from patients with head and neck cancer in the laboratory before and after a low~     carbohydrate diet may help determine any changes in tumor metabolism.~   "
38343|NCT02555163|"~     Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor~     (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT)~     in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness~     of tumor resection and peri procedure complication.~   "
38344|NCT02555150|"~     The purpose of this randomized, double-blind, crossover study is to compare two long-acting~     stimulant formulations—once-daily PRC-063 and once-daily lisdexamfetamine (LDX)—through a~     15-hour period on driving performance, as measured with a driving simulator, in adult~     patients with ADHD.~   "
38345|NCT02555137|"~     This is a prospective, international, multicenter outcome cohort study. This study starts at~     the moment patients visit the outpatient clinic 3 to 6 months after a diagnosis of acute PE~     as part of routine medical care. If patients consent to study participation, the CTEPH~     clinical prediction score will be calculated. CTEPH is considered to be not present in~     patients with a low probability (≤6 points) and no symptoms suggestive of CTEPH, i.e.~     dyspnea on exertion, edema, newly developed palpitations, syncope or chest pains.The~     remaining patients with either high probability (>6 points) or who report symptoms that may~     be associated with CTEPH will be subjected to the 'rule-out criteria'. CTEPH will be assumed~     not present in patients with an age- and gender dependent normal NT-proBNP level (as defined~     by the assay's manufacturer), in the absence of any of the 3 ECG criteria. Patients who have~     an abnormal result from the 'rule-out criteria' will be referred for transthoracic~     echocardiography. All echocardiograms will be performed according to a predefined~     standardized protocol.~      In case of echocardiographic intermediate or high probability of PH, patients will be~     referred for further diagnostic work-up of suspected CTEPH starting with perfusion lung scan~     or VQ-scan and right heart catheterization, of which the results will be discussed by an~     independent interdisciplinary working group of PH specialists, to ensure optimal diagnostic~     management. This latter diagnostic work-up of an abnormal echocardiograph lies within the~     setting of standard medical care.~      All patients who were not diagnosed with pulmonary hypertension of any origin, or with NYHA~     class III or IV heart failure due to left ventricular systolic dysfunction, left ventricular~     diastolic dysfunction or significant valvular lesions, will be followed for a total of 2~     years from the index PE diagnosis. During that period, the study protocol will not interfere~     with standard patient care, allowing diagnostic tests as deemed indicated by the treating~     physician including echocardiography in case of new respiratory symptoms. At the end of the~     follow-up period, all patients will be subjected to a second echocardiography that will be~     handled according to the above stated procedures to evaluate the presence of CTEPH.~   "
38346|NCT02555124|"~     The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral~     administration.~   "
38347|NCT02555111|"~     Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the~     recurrence of thromboembolic event compared to an untreated group in patients with chronic~     portal vein thrombosis without high risk thrombophilia.~   "
38348|NCT02555085|"~     The primary objective of the study is to evaluate the safety and tolerability of single~     ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy~     volunteers. The secondary objectives of the study are to estimate the PK parameters of~     single ascending IV doses of BIIB063; to estimate the PK parameters and absolute~     bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of~     single ascending doses of BIIB063.~   "
38349|NCT02555072|"~     This is a Phase IV study cohort, uncontrolled, composed of two segments: children and~     healthy adults. It will be included 2756 children and 2005 adults, evaluated initially in~     six different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years~     after vaccination). The Paraiba state was selected for the study because in this region~     there are no yellow fever virus dissemination and therefore no NIP recommendation for~     people's routine vaccination. However, the NIP indicate yellow fever vaccination for~     individuals who are moving to areas with virus circulation. The study will take place in six~     (6) Basic Health Units of three (3) municipalities (2 units per municipality) in the state~     of Paraíba. The selected municipalities are: Alhambra, Caaporã and Conde. The study target~     population consisted of healthy children and adults of both sexes. Children must be between~     9 months and 4 years,11months and 29 days; adults between 18 and 50 years. It will be~     eligible for the study, people who have never received the yellow fever vaccine checked in~     vaccine design and history and who agree to participate. Not be included participants with~     any contraindication to vaccination against yellow fever and individuals who previously~     moved to risk areas for extended periods. The study main objective is to assess the immune~     status of children and adults who have never vaccinated, they will receive the first dose of~     17DD yellow fever vaccine provided by the study and will be monitored for 10 years.~     Depending on the results of the analyzed of the data, the period of monitoring may be~     extended.~   "
38350|NCT02555059|"~     The objective in this study is collecting post-marketing information on the safety and~     efficacy of Ciproxan injection under the routine clinical practice.~   "
38352|NCT02555033|"~     Aging results in a gradual decline of physical abilities and consequently in functional~     impairments which increases the risk of falls in elderly people. It has been shown, that~     balance and resistance training can counteract the effects of aging. The aim of this study~     was to investigate effects of instability resistance training (IRT), combining balance and~     resistance training, on measures of muscle strength / power and balance for falls in healthy~     community-dwelling older adults. Therefore 75 elderly people, aged 65 - 80 years (Mage =~     70.4; SD = 4.3 years) were assigned into three intervention groups: machine-based (M-RT),~     machine-based instability (M-IRT), free weight instability resistance training (F-IRT). All~     three groups exercised over 10-weeks with two training sessions per week. Assessment of~     muscle strength (e.g. maximal isometric leg extension strength), power (e.g. chair rise~     test) and balance (e.g. gait, functional reach test) was conducted before and after~     training.~      Based on the principle of training specificity, it is assumed, that groups to improve better~     within their respective training modality. Thus, the investigators hypothesis that regarding~     measures of strength and power, M-RT performs better than M-IRT, performs better than F-IRT.~     As to measures of balance, we hypothesis that F-IRT performs better that M-IRT, performs~     better than M-RT.~   "
38353|NCT02555020|"~     Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative~     carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery~     (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been~     widely investigated and have been shown to be associated with improved postoperative~     outcomes, some individual constituents of these protocols, including preoperative~     carbohydrate treatment, have not been subject to such robust analysis.To assess the effects~     of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on~     postoperative recovery and insulin resistance in adult patients undergoing elective surgery.~   "
38354|NCT02555007|"~     Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant~     Pleural Mesothelioma, but all the studies published thus far were based upon a variety of~     empirical and possibly suboptimal schedules, with inconsistent results. Mathematical~     modeling showed by simulation that a new metronomic protocol could lead to a better safety~     and efficacy profile.~      Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate~     efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic~     NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and~     an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an~     alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical~     Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is~     two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and~     consolidate the calibration of the average parameters of the model. Depending the phase Ia~     result, and after favorable decision of a consultative committee, the extension phase (phase~     Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal~     Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC~     v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.~      An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.~      Discussion: this ongoing trial is the first to prospectively test a mathematical optimized~     schedule in metronomic chemotherapy. As such, this trial can be considered as a~     proof-of-concept study demonstrating the feasibility to run a computational-driven protocol~     to ensure an optimal efficacy/toxicity balance in patients with cancer.~   "
38355|NCT02554994|"~     Frailty is a highly prevalent, progressive condition in older adults that is characterized~     by multisystem physiologic impairments and vulnerability to stressful events, leading to~     increased risk of geriatric conditions, disability, falls, hospitalization, and mortality.~     An effective public health intervention to improve frailty in a rural aging population with~     limited resources remains unknown. The purpose of our study is to evaluate the effectiveness~     of multidimensional public health intervention to reduce frailty and related geriatric~     conditions in older adults in rural communities. Our hypotheses are that a multidimensional~     intervention consisting of group exercise, nutritional support, depression management,~     polypharmacy, and home safety intervention over a 6-month period will improve frailty and~     selected geriatric conditions in older adults who are in low socioeconomic status or living~     alone in a rural community. Our primary outcome is short physical performance battery at 6~     month. Secondary outcomes include frailty status, nutritional status, depression, falls,~     sarcopenia, and health care utilization. The investigators will conduct a designed delay~     trial by implementing our intervention in one town for the first 6 months (intervention~     group), while measuring the outcomes without any intervention in another town (serving as a~     control group); in the following 6 months, the investigators will implement the 6-month~     intervention in the control town. The findings from our study will inform us to find~     effective public health interventions to promote healthy aging in resource-limited, rural~     populations.~   "
38356|NCT02554981|"~     This study will evaluate the efficacy of Restasis® in participants with dry eye disease who~     engage in electronic visual tasking.~   "
38357|NCT02554968|"~     This study will utilize Rasch analysis to study the construct validity and reliability of~     five shoulder-related patient-reported outcome measures in patients reporting shoulder~     impairment following surgery for head and neck cancer.~   "
38358|NCT02554955|"~     This study will evaluate the efficacy and safety of intravenous daclizumab in combination~     with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart~     transplant, and at risk of impaired kidney function. The anticipated time on study treatment~     is 6 months, and the target sample size is 44 individuals.~   "
38359|NCT02554942|"~     This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in~     adults with solid tumors being treated with platinum-based chemotherapy capable of inducing~     anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is~     approximately 208 individuals.~   "
38360|NCT02554929|"~     This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for~     Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive~     Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting~     criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient~     Program and participants will be randomized to either the Taming Sneaky Fears group or a~     parent psycho-education and child socialization group. Trained clinicians blinded to all~     measures and treatment assignment will administer pre, post and 6-month follow-up outcome~     measures. Investigators assess within-the-child and within-the-parent/environment factors~     that predict treatment outcomes.~   "
38387|NCT02554578|"~     The purpose of this study is to improve medication adherence, engagement and support to~     heart transplant patients through implementation of a new clinical care programme conducted~     by the clinical pharmacy service in cooperation with the heart transplant team and supported~     by mobile health (mHealth).~   "
38361|NCT02554916|"~     This is an exploratory study designed to investigate the effects of aerobic dual belt~     treadmill walking versus traditional treadmill exercise on gait performance and functional~     capacity in older adults at risk for mobility disability. Identifying the relationship~     between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking~     abilities will serve to optimize current rehabilitation approaches.~   "
38362|NCT02554903|"~     STUDY OBJECTIVES Primary objective(s) To evaluate the effect of macitentan 10 mg on~     pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary~     hypertension (PH) after left ventricular assist device (LVAD) implantation.~      Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on~     cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD~     implantation.~      To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD~     implantation.~      Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to~     placebo on right ventricular function in subjects with PH after LVAD implantation.~      To explore the potential effect of macitentan 10 mg as compared to placebo on selected~     clinical events in subjects with PH after LVAD implantation.~      To explore the potential effect of macitentan 10 mg as compared to placebo on renal function~     as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.~   "
38363|NCT02554890|"~     The purpose of this study is to assess the effect of in-hospital initiation of~     sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in~     NT-proBNP in patients who have been stabilized following hospitalization for acute~     decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection~     fraction (LVEF) ≤ 40%).~   "
38364|NCT02554877|"~     The purpose of this study is to determine whether PF-06291874 is effective in the treatment~     T2DM~   "
38365|NCT02554864|"~     The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate~     Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the~     subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests~     that different injection sites within the canal may produce different degrees of analgesia~     and quadriceps motor block. This trial seeks to determine the effects of various ACB~     injection sites on postoperative analgesia and motor power following ACL repair.~   "
38366|NCT02554851|"~     Phase III clinical trial, multicenter, controlled, randomized, double-blind, with two~     parallel groups (experimental and control). Both study groups will receive standard therapy~     currently available in treatment centers for diabetic foot ulcer (DFU). Associate with the~     standard therapy, it will be given the recombinant human Epidermal Growth Factor (rhEGF) to~     experimental group and in the control group, it will be given a formulation without~     pharmacological effect (placebo) in order to masking and control of intralesional~     application. Participants with type 1 and type 2 diabetes mellitus (DM) diagnosed with DFU~     for at least 4 weeks, treated in referral centers participating in the study, agreeing to~     participate after reading, understanding and signing of Informed Consent (IC); meet all the~     inclusion criteria; and presenting no exclusion criteria. The Informed Consent (IC) should~     be applied to potential participants, as recommended by the regulations and ethical~     consensus before beginning any procedure related to the clinical trial. In the early weeks,~     participants will be evaluated at the research centers by the study team (doctors and / or~     staff). The number of visits will be determined by the investigator, thus ensuring~     appropriate assistance to participants, and avoiding any complications with DFU. By meeting~     the eligibility requirements (inclusion and exclusion criteria), the participant will~     undergo a thorough evaluation of the DFU before the start of treatment. This assessment is~     precisely to classify the condition of the ulcer before treatment and provide relevant~     information for statistical analysis of the protocol. If eligible, the participant will be~     randomly set to treatment arm (placebo or rhEGF) and the administration of investigational~     product associated with predefined standardized outpatient therapy will be initiated. This~     administration occurs three times per week until the DFU is scarred, not exceeding 8 weeks~     of treatment (T.01 to T.08) .The study will be randomized and balanced according to the type~     and size of the DFU. This balancing is necessary to ensure that both treatment groups are~     homogeneous for participants under different conditions. All participants will be applied~     established standard therapy for the treatment of DFU. The objective is to provide regular~     care for healing and reduce possible bias in the efficacy analysis and product safety. After~     the treatment period (last dose of the experimental drug) the participant will start the~     follow-up period, with 16 weeks duration. The participant shall be subjected to weekly~     visits for ongoing assessment of DFU, however, according to the investigator, may result in~     unscheduled visits to assess local or general clinical events. After the monitoring period,~     the participant will be observed for 24 additional weeks, visits every 4 weeks (E.01 E.24 a)~     having beginning one week after the last visit of follow-up. This period is intended to~     assess possible events related to the efficacy and safety that can happen in the period,~     mainly for analysis of secondary endpoints.~   "
38367|NCT02554838|"~     This project aims to determine the respective impacts of two routine care regarding phobic~     of falling seniors on the mobility restriction. The investigators used a monocentric,~     randomized and controlled research according to two parallel groups : physical activity,~     home assessment and modification (rehabilitation group) versus physical activity, home~     assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT~     group). The investigators will assess the efficacy of usual care (rehabilitation group) and~     the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space~     Assessment.~   "
38368|NCT02554825|"~     This study evaluated the impact of the three-year Healthy Futures program on teen sexual~     behaviors in three Massachusetts cities.~   "
38369|NCT02554812|"~     This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics,~     pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in~     combination with other cancer immunotherapies in patients with locally advanced or~     metastatic solid tumors. The primary purpose is to assess the safety and early signs of~     efficacy of various avelumab combinations with other cancer immunotherapies, optimizing~     dosing regimens as appropriate, in a limited series of indications.~   "
38370|NCT02554799|"~     This study will be conducted in a single centre, as an open single dose two parallel cohorts~     design with oral doses of MMV390048 administered in healthy male and female subjects between~     18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study.~     On Day 1 of the study each subject will receive one of the two MMV390048 prototype~     formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3~     after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14,~     19, 26 and 29.~   "
38371|NCT02554786|"~     The purpose of the trial is to evaluate the efficacy and safety of two different doses of~     QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses~     (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic~     patients as determined by pulmonary function testing, and effects on asthma control~   "
38372|NCT02554773|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ALN-AT3SC~     in male patients with moderate or severe hemophilia A or B.~   "
38373|NCT02554760|"~     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the~     flank using an applicator with the Crown Cooling Insert.~   "
38374|NCT02554747|"~     Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual~     impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29%~     of patients. Because of DME, 550 intravitreal injections were given at Odense University~     Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing~     prevalence of diabetes, the number is expected to rise significantly for the years to come.~      The investigators hypothesize that combination therapy with intravitreal aflibercept and a~     new computer navigated photocoagulations system (Navilas®) leads to a decreased need for~     intravitreal injections.~      Further, the investigators wish to identify retinal risk markers for DME treatment outcome~     to assist individualized treatment planning. The evaluation of the baseline level of macular~     ischemia as marker of successful treatment outcome is of particular interest as this is~     still highly debatable and may prove a significant prognostic factor of anatomical and~     functional outcome to anti-VEGF treatment.~      The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1~     study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal~     aflibercept and conventional Pascal laser (Group B) in the treatment of DME.~      Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal~     thickness > 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy~     Study (ETDRS) letters.~      The investigators believe that this study holds the potential to set precedent for a new~     gold standard of DME-treatment with increased treatment effect, reduced risks and a more~     cost-effective approach.~   "
38375|NCT02554734|"~     Phase I open, randomized cross-over pharmacokinetic study.~   "
38376|NCT02554721|"~     The primary objective of this study is to investigate the effects of Cilostazol,~     Acetylsalycylic acid and Clopidogrel alone as well as combinations of~     Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function~     (PF) testing.~   "
38377|NCT02554708|"~     To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation~     aneurysms.~   "
38378|NCT02554695|"~     This protocol addresses: 1) How gene expression changes in bone cells are affected by aging?~     2) Is aging associated with decreased signaling between bone cells? 3) How does treatment~     with the osteoporosis medication denosumab affect bone cell signaling?~   "
38379|NCT02554682|"~     The primary objective is to conduct a pilot study to determine the efficacy of~     evidence-based interventions delivered in primary care clinic settings on parent-teen health~     communication.~   "
38380|NCT02554669|"~     Physical activity performed in the postprandial state has the ability to blunt postprandial~     glycemia acutely, even as a result of very light or small amounts of postprandial physical~     activity. Postprandial physical activity decreases postprandial glycemia more effectively~     than activity performed in the post-absorptive state. However, studies comparing~     postprandial and postabsorptive physical activity have measured glycemic outcomes in only~     short periods of time (hours) or have used a very large dose of physical activity.~      Physical activity have the ability to entail an acute increase in markers of systemic~     inflammation.Previous studies has also shown that systemic inflammation is increased during~     glycemic spikes, such as after a high carbohydrate load. Therefore the effect of~     postprandial physical activity is difficult to predict. One one hand it might increase~     markers of systemic inflammation. On the other hand it might decrease systemic inflammation~     as a result of a blunting effect on postprandial glycemia. The effect of physical activity~     after carbohydrate intake might therefore also differ from postabsorptive physical activity.~      Purpose of the study: I) The investigators hypothesized that light physical activity~     performed in the post-prandial sate decrease blood glucose in a day and night cycle compared~     to the same activity performed in the postabsorptive state and a control day. II) To test~     whether postabsorptive and postprandial light physical activity do affect markers of~     systemic inflammation different.~      12 participants diagnosed with hyperglycemia but not on hypoglycemic medication took part in~     a randomized cross-over trial with 3 test days. A control day with no physical activity, and~     two days similar to the control day except that one of them contained a one hour bout of~     treadmill walking prior to breakfast and the other a similar exercise bout after breakfast.~     Continuous glucose monitoring was performed from start of exercise / breakfast until the~     morning next day (at least 22 hours). Venous blood was also sampled at given timepoints~     (before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast. Dietary~     intake was individually standardized prior to and during test days.~   "
38381|NCT02554656|"~     Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general~     clinical practices.~   "
38382|NCT02554643|"~     The present study aims to evaluate the impact of a soccer training program lasting 12 weeks~     in patients with type 2 diabetes mellitus. 60 sedentary adults and elderly patients with~     type 2 diabetes mellitus (age: 50-75 y), with a BMI > 25kg/m2 and > 29kg/m2, respectively,~     from the Hospital of the Medical Faculty of São Paulo University will participate in this~     study. They will be randomly divided in 3 groups (soccer, running and control). All patients~     will undergo the following assessments: anthropometric, dietary, physical performance,~     inflammatory, metabolic and hormonal parameters such as gene expression, bone markers and~     predictors of cardiovascular disease. In addition the investigators aim to evaluate the body~     composition of these patients by DXA, and muscle and visceral lipids content by proton~     spectroscopic MRI.~   "
38383|NCT02554630|"~     Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of~     mortality is in preterm neonates, especially low birth weight (LBW), and very low birth~     weight (VLBW) neonates. The estimated cost of caring for these patients is approximately~     $700 million in the US alone.~      In an effort to help mature the neonatal immune system, several adjuvant therapies have been~     studied; however, none have been implemented in clinical practice. One of the most~     frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs~     detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and~     initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a~     viable approach to reducing the incidence of early and late sepsis.~      This research study will characterize immune genomic expression and functional capacity at~     the time of birth in both term and preterm neonates and determine what effects, if any, that~     adjuvants have on this function. Additionally, this study will seek to determine if immune~     function correlates with certain microbiota.~   "
38384|NCT02554617|"~     The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in~     healthy subjects among Thai populations.~   "
38385|NCT02554604|"~     The study is design to assess if there is a correlation between diagnosis of preeclampsia~     and its severity to changes in HDL quality, in terms of composition and function and to~     determine whether preeclampsia-induced changes in VOCs in saliva can be used for the early~     diagnosis of preeclampsia.~   "
38386|NCT02554591|"~     The investigators propose to conduct a retrospective study of single agent ceritinib in~     patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged~     adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape~     before ceritinib and at the time of disease progression.~   "
38388|NCT02554565|"~     Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients~     with cervical cancer compared to the early detection of minimal metastatic disease.~   "
38390|NCT02554539|"~     The purpose of this study is to understand the mechanism of communication between the~     uterine environment and the preimplantation human embryo. The investigators are interested~     in understanding how the in-utero environment during the window of implantation is different~     in normal weight and overweight/obese women and how this may impact the programming of the~     developing embryo.~   "
38391|NCT02554526|"~     Using whole blood samples and plasma samples obtained from some hemophilia A patients with~     inhibitors, the investigators will perform the coagulation assessment in the co-presence of~     aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under~     blood flow conditions.~   "
38392|NCT02554513|"~     The purpose of the proposed research is to examine the effects of two treatment approaches~     on speech production involving speakers with chronic apraxia of speech (AOS) and aphasia.~     The planned investigation is designed to examine the acquisition, maintenance and~     generalization effects of each treatment. One approach, electropalatography (EPG) uses~     visual biofeedback in conjunction with articulatory-kinematic treatment and the other~     approach, sound production treatment (SPT) is one of the most systematically studied~     articulatory-kinematic treatments for AOS.~   "
38393|NCT02554500|"~     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim~     at replacing pseudarthrosis by well vascularized bone and improving microcirculation.~     Although previous studies indicate that remote ischemic preconditioning (RIPC) can~     accelerate bone healing in case of non-union, only a few studies focused on the elucidation~     of its mechanisms of action. Therefore, the aim of this study is to evaluate the~     microcirculatory effects of remote ischemic preconditioning (RIPC) on scaphoid bones and~     metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.~   "
38394|NCT02554487|"~     Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major~     importance. First because of the high occurrence rate of stroke and the fact that it is a~     frequent cause of long-term disability in adulthood. Second because SDB (obstructive,~     central and mixed forms) affects more than 50% of stroke survivors and has a detrimental~     effect on clinical stroke outcome. Third, spontaneous and learning-dependent~     sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke~     rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with~     Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive,~     central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion~     volume and on clinical stroke outcome.~      To this end, the investigators recruit and prospectively follow 3 groups of patients with~     ischemic stroke over 1 year. During the first night after hospital admission due to acute~     stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with~     significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) ≥ 30/h, are~     randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts~     the second night following hospital admission and ends 90 days later. Stroke patients~     without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the~     lesion volume and stroke outcome without the additional burden of SDB.~      Lesion volume one day after hospital admission due to acute stroke (after potential lysis~     therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume~     measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared~     between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as~     patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by~     clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke.~     Cognitive outcome is assessed during hospitalization (within the first week following~     stroke) and after the treatment period of 90 days by neuropsychological tests assessing~     attention and memory. In addition, baseline assessment of physiological parameters such as~     blood pressure and endothelial function/arterial stiffness are assessed during the first~     weeks following stroke and at the end of the treatment period, i.e. approximately 90 days~     following stroke.~   "
38395|NCT02554474|"~     Being physically active can reduce pain and fatigue, improve mobility and enhance quality of~     life in people with arthritis, but adherence to an active lifestyle is poor, with less than~     half of people with arthritis being active. The primary goal of this randomized controlled~     trial is to assess the efficacy of a physical activity coaching model to improve physical~     activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and~     Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless~     physical activity tracker) paired with a FitViz application, a group education session, and~     telephone counselling by a physiotherapist.~   "
38396|NCT02554461|"~     On the basis of clinical and movement analysis records players are informed on what~     parameters can be optimized in order to improve their performance and avoid injuries~   "
38397|NCT02554448|"~     The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in~     peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox~     treatment and chemoradiotherapy,before and after surgery.~   "
38398|NCT02554435|"~     Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to~     physical activity. Most older adults do not participate in healthy levels of physical~     activity. Physical activity promotion and counseling from a primary health care provider is~     important for disease prevention. In addition to counseling, an activity monitor can~     increase physical activity through self-regulation. Two types of monitors are available:~     pedometers and electronic activity monitors (EAMs). Research shows that both monitors are~     motivational devices that can increase physical activity. Pedometers count steps of the~     wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary~     time. EAMs may also offer more behavioral change techniques and opportunities for~     self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to~     a pedometer on increasing physical activity and decreasing cardiovascular risk within older~     adult, primary care patients. The study will include sedentary, overweight primary care~     patients, 55-74 years of age with access to a smart phone or tablet. All participants will~     receive brief physical activity counseling. Participants will then be randomized to receive~     a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months.~     Investigators will evaluate the following outcomes: physical activity, cardiovascular risk~     (Framingham risk calculator, fitness), psychological feeling toward exercise, physical~     function, health status, exercise motivation and self-regulation. The investigators~     hypothesize that EAMs will be more effective than pedometers in improving these outcomes.~     The results of this pilot test will aid in the translation of effective physical activity~     intervention components to primary care clinics for cardiovascular disease prevention.~   "
38399|NCT02554422|"~     Feasibility of the objective measurement of the ossicular chain mobility, by using a~     force-measuring device based on a fiber optics sensors (PalpEar).~   "
38400|NCT02554409|"~     The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy~     Registry will be a prospectively recruited pregnancy surveillance program designed to~     collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and~     fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.~   "
38401|NCT02554396|"~     This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and~     safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1,~     PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects~     on improving near-vision acuity.~   "
38402|NCT02554383|"~     The objective of this trial is to determine whether certain subgroups of children with acute~     sinusitis exist in whom antibiotic therapy can be appropriately withheld.~   "
39976|NCT02533726|"~     The purpose of this study is to test whether optimal patient turning, strictly every 2 hours~     with at least 15 minutes of tissue decompression, reduces the occurrence of hospital~     acquired pressure ulcers.~   "
38403|NCT02554370|"~     Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to~     improve motor signs and reduce dopaminergic treatment and related motor complications in~     patients with severe forms of Parkinson's disease (PD). However, psychological disorders and~     socio-familial maladjustment are less clearly improved with subthalamic stimulation with an~     aggravation of the social adjustment described in about 1/3 of cases, with work disruption,~     divorce or familial conflict. The caregivers have also been reported to present negative~     well-being after surgery with an aggravation of the quality of life. In the present study,~     the investigators evaluate the effects of a perioperative psychoeducational programme to~     avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic~     stimulation, and their caregivers, in a randomized controlled study.~   "
38404|NCT02554357|"~     Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single~     injection nerve blocks.~   "
38405|NCT02554344|"~     The purpose of this study is to determine the safety, feasibility, and regression rate of~     using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary~     objectives of this study is to evaluate patients with CIN3 for the presence of high-risk~     Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from~     patients with CIN3 to determine which factors play a role in persistence of CIN3.~   "
38406|NCT02554331|"~     Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an~     underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy~     body disease. Identifying additional abnormal clinical features may help in identifying~     those at greater risk of evolving to a more severe syndrome. Because gait disorders are~     common in the synucleinopathies, early abnormalities in gait in those with RBD could help in~     identifying those at increased risk of developing overt parkinsonism and/or cognitive~     impairment.~      The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to~     identify sensitive and early biomarkers:~        1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and~        2. to track their evolution in the parallel with the disease progression.~      Main objective: In comparison with age and gender matched-controls, to identify in patients~     with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal~     characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).~      Secondary objective:~        1. In comparison with age and gender matched-PD patients, to identify in patients with RBD~          a smaller reduction of gait velocity (and other abnormalities of spatio-temporal~          characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).~        2. In patients with RBD to identify correlations between the spatio-temporal~          characteristics modifications of gait between a single (gait) and a dual-task~          (gait+cognitive task) and the percentage of REM without atonia - the dopamine~          transporter (DAT) density using FP-CIT single-photon emission computed tomography; the~          reduction of the olfactory discrimination and thresholds.~        3. In patients with RBD to track the spatio-temporal characteristics evolution of gait~          over time (every 6 months for 2 years)~   "
38407|NCT02554318|"~     Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting.~     Wasting reduces lean body mass and may cause physical function impairment. This study aimed~     to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight~     and physical function changes among active pulmonary tuberculosis patients with standard~     therapy.~   "
38408|NCT02554305|"~     This study compares between the clinical, hematological, inflammatory and neurological~     outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which~     different oxygenation systems will be used.~   "
38409|NCT02554292|"~     The main objective of the SeQuent® Please Neo post market surveillance is to assess the~     clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring~     balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real~     world' setting for the treatment of in-stent restenosis.~   "
38410|NCT02554279|"~     The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant~     Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in~     women undergoing controlled ovarian stimulation (COS) following GnRH treatment.~   "
38411|NCT02554266|"~     The study will enroll patients presenting with claudication, or critical limb ischemia~     (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion~     appropriate for angioplasty that is below the knee. Subjects will be treated with the~     Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed~     clinically for a minimum of 2 years.~   "
38412|NCT02554253|"~     Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia~     as well as as an analgesic. It has been shown to have anti-inflammatory properties which may~     decrease post-operative complications following cardiac surgery with cardiopulmonary bypass~     that are thought to associated with inflammation. Some studies have shown that ketamine does~     decrease these complications when compared with anesthetics that are not commonly used in~     our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication~     which is used for induction of anesthesia. Ketamine has not been compared with propofol for~     potential to reduce post-operative complications associated with the inflammatory process.~     This study aims to see if ketamine will reduce the incidence of cognitive dysfunction,~     delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic~     impact of ketamine compared propofol will be investigated.~   "
38413|NCT02554240|"~     This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients~     with osteoarthritis of the knee.~   "
38414|NCT02554227|"~     Spondylodiscitis is an infectious disease of the intervertebral discs and adjacent vertebral~     bodies, which often has a protracted progression. Diagnosis is frequently delayed because of~     the unspecific pathology and a lack of specific infection markers. However, an early~     diagnosis is fundamental to prevent long periods with symptoms including extensive back pain~     and progressive and destructive changes of the spine.~      Cytokines can be helpful to extend the knowledge about diverse biological processes.~     Furthermore, they are a promising category of biomarkers that are already present in the~     early phases of developing diseases. Currently, little is known about the participation of~     cytokines in Spondylodiscitis. The aim of this study is to establish a non-invasive method~     to improve the diagnosis of spondylodiscitis. Therefore, blood and tissue samples will be~     analyzed at different time points for the concentration of specific cytokines to select~     potential marker cytokines via a Multiplex Assay. After successful identification of marker~     cytokines, verification of the results will be done by expression analysis of~     cytokine-producing cells.~      The potential of such a diagnostic method lies in reducing medical costs and preventing~     extensive pain and structural changes of the spine.~      Experimental research will be performed with the approval of the ethic committee of the~     medical faculty of the University of Cologne.~   "
39977|NCT02533713|"~     This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on~     the musculoskeletal system and health-related quality of life.~   "
38415|NCT02554214|"~     This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30~     patients who satisfy entry criteria is estimated to be appropriate to provide safety and~     performance data for this study.~      The objectives of the study are to verify the performance and safety of the Glafkos~     adjustable glaucoma drainage device system. Performance will be measured assessing the~     possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by~     the incidence and severity of adverse events.~      The Glafkos device will be implanted in combination with a seton tube. The implant is placed~     under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end~     of the draining tube is linked to a seton draining tube, which is linked to a plate placed~     under the extraocular muscles, creating a filtering space at the orbit (filtering bleb).~   "
38416|NCT02554201|"~     The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent~     from late complications. The present study is to evaluate the efficacy of electrical~     pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in~     NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of~     60 eligible patients will be involved and divided into EPNS or TES group according to their~     location of medical treatment. The primary endpoint is lower urinary tract syndromes~     (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and~     residual urine volume.~   "
38417|NCT02554188|"~     The objective of the study is to obtain estimates of the feasibility, safety and impact of a~     fasting mimicking diet on elderly subjects and to examine the effects of the diet on immune~     function.~   "
38418|NCT02554175|"~     The aim of this study was to determine the target propofol concentration needed to provide~     adequate hypnosis for induction and tracheal intubation for Schnider model using total body~     weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic~     adverse effects associated with these propofol target concentrations.~   "
38419|NCT02554162|"~     This study examines if there are differences in satiety responses between structurally~     different wholegrain rye products.~   "
38420|NCT02554149|"~     The purpose of this study was to develop a radiological method to measure stem anteversion~     and to determine its validity and reliability.~   "
38421|NCT02554136|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and~     both together in a 3 period repeatedly~   "
38422|NCT02554123|"~     A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s~     haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be~     performed. The patients will be randomized into 2 groups:~        -  Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and~          application of Vitamin E ointment on the surgical bed.~        -  Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of~          Vaseline on the surgical bed.~      Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need~     for morphine rescue will be investigated.~   "
38423|NCT02554097|"~     Patients with gallstone and confirmed common bile duct stones are registered in this study.~     The three managements for common bile duct stones are endoscopic sphincterotomy (EST),~     laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile~     duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative~     investigations, operative method, operative time, conversion to open procedure,~     intraoperative and postoperative complications, and the presence of retained and recurrent~     stones. All patients were followed up for 3 years by telephone interview ang outpatient~     visits. Abdominal US and liver function tests were carried out whenever any abdominal~     symptom appeared during the follow-up period. If there were unusual findings, magnetic~     resonance cholangiopancreatography(MRCP) was carried out.~   "
38424|NCT02554084|"~     The purpose of this study is to evaluate a new instrument that takes digital images of tear~     film (a thin film that coats the eye that is made up of oil and water). The investigators~     are interested in measuring how the thickness of the tear film varies through time. The goal~     is to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for~     future clinical diagnosis.~   "
38425|NCT02554071|"~     A single arm pilot study conducted to assess the feasibility of having Manitoba Pharmacists~     provide support (product and cognitive) to low-income (receiving social assistance) smokers~     wishing to quit smoking.~   "
38426|NCT02554058|"~     A novel rehabilitation bike has been developed for patients with incomplete spinal cord~     injuries that incorporates mechanical stimulators on the bike pedals to stimulate the~     sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle~     strengthening has been reported by NASA to improve muscle atrophy in astronauts in~     zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict~     that the combination of mechanical stimulation with cycling may be similar enough to walking~     over ground to lead to gains in balance and mobility. The present study will evaluate the~     therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal~     pathways in patients with incomplete spinal cord injuries.~   "
38427|NCT02554045|"~     Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported.~     However, a better understanding of the complex role of PDE5 in fat metabolism and whole body~     homeostasis requires the use of transgenic animal models either lacking or overexpressing~     PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and~     metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of~     expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral~     vs. subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low~     calorie intake) could reveal if PDE5 can be considered to be a reliable 'marker' of~     metabolic dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5~     inhibitor sildenafil in a mouse model of diet-induced insulin resistance caused a~     significant improvement in insulin sensitivity . Also, in humans chronic exposure to~     tadalafil confirmed an improvement of insulin sensitivity in men with erectile dysfunction.~     However, the efficacy of long-term treatment with PDE5i awaits demonstration in human~     metabolic diseases such as obesity and insulin resistance.~      The primary purpose of the study is to investigate the effects of tadalafil taken once a day~     on body composition in men with sexual distress and/or erectile dysfunction.~   "
38428|NCT02554032|"~     The ACE trial is a multicentre, randomized controlled trial comparing axillary vs.~     innominate artery cannulation for established antegrade cerebral perfusion in patients~     having aortic surgery (thoracic and aortic arch) requiring deep hypothermic circulatory~     arrest using a non-inferiority trial design.~   "
38429|NCT02554019|"~     The purpose of this study is to evaluate the safety and efficacy of repeated intravenous~     infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE)~     compared with people who receive a placebo.~   "
38430|NCT02554006|"~     A single-center, randomized trial of admitted patients with ischemic heart disease receiving~     percutaneous coronary intervention and stent implantation will be conducted at University~     Hospital of Ferrara. Patients will be randomized to either the control (standard care) or~     the bundle group in which patients will receive counseling regarding dual antiplatelet~     therapy management, advantages and side effects, screening for depression or anxiety,~     standardized education. The primary endpoint will be the difference in the quality of life~     as assessed by EQ-5D questionnaire.~   "
38431|NCT02553993|"~     The objective of this study was to: compare the training and maintenance effects of 3~     balance training programs (2 kinds of exergame systems and 1 conventional weight-shifting~     training program) on cognitive function of subjects with chronic stroke.~   "
38432|NCT02553980|"~     Practicing a habitual physical activity is important for health. A Virtual Trainer (VT)~     online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for~     encouraging an active lifestyle. This project intends to further improve the VT (3rd~     version) which incorporates more effective psychological and e-health theories, and~     disseminate it to Hong Kong middle-aged adults.~   "
38433|NCT02553967|"~     Breast reconstruction is an integral part of the management of patients with breast cancer~     and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying~     aesthetic and functional result (sensitivity) and that would enable the patient to~     appropriate the reconstructed breast. Patient satisfaction assessed subjectively by~     questionnaires would be better in autologous reconstructions than in reconstructions by~     prosthesis.~      The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to~     describe the brain functional changes of sensory projections after immediate or secondary~     breast reconstruction.~   "
38434|NCT02553954|"~     Epidemiological data show that the incidence of carcinoma, the most common cancer, is~     strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers~     in the elderly population) derive from keratinocytes of the basal layer of the epidermis,~     from differentiated keratinocytes of the more superficial layers or from stem cells of hair~     follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal~     fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher~     the molecular pathways activated during the aging of these tissues that may explain why they~     have a so different propensity to undergo a malignant transformation. Given that senescent~     cells accumulate in the dermis and epidermis with age, we will constitute two groups :~     young skin that we arbitrarily limit to the range ≥ 18 and ≤ 40 and aged skin ≥ 55.~      Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years~     and ≥ 55 years) the expression of senescence markers on healthy skin tissue.~   "
38435|NCT02553941|"~     This phase Ib trial studies the side effects and best dose of ibrutinib when given together~     with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur~     or spread (higher risk) and who were previously treated or untreated and unfit for or~     refused intense therapy. Ibrutinib and azacitidine may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
38436|NCT02553928|"~     Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared~     with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range~     5-18.~   "
38437|NCT02553915|"~     This project aims to evaluate whether a dose-response relationship exists between dose of~     polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in~     markers of inflammation, and whether these effects differ from placebo. A key secondary aim~     is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with~     current major depressive disorder (MDD). To address these aims, the project will use a~     four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus~     three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study~     is to be conducted at two sites: Emory University School of Medicine, and Massachusetts~     General Hospital. Eligible participants will be between the ages of 18-80 who have current~     MDD, are overweight, and who demonstrate peripheral inflammation, defined as an high~     sensitivity C-reactive protein (hs-CRP) level ≥ 3 mg/L. The primary outcome will be change~     in plasma interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear~     cells (PBMC) Tumor Necrosis Factor-alpha (TNF-α) expression levels in EPA- versus~     placebo-treated participants. The results of this investigation are intended to be used to~     design and power a larger definitive test of the efficacy and biological effects of EPA in~     patients with major depressive disorder.~   "
38453|NCT02553707|"~     This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in~     participants with breast cancer and malignant bone disease, with moderate to severe pain.~     All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain~     response will be measured on Days 1-7. The anticipated time on study treatment is 3 days,~     and the target sample size is 182 individuals.~   "
38454|NCT02553694|"~     The purpose of this study is to determine how satisfied patients are when undergoing an~     overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what~     factors affect obstructive sleep apnea (OSA) treatment use.~   "
38455|NCT02553681|"~     This will be an up to six months, subject-masked, contralateral, parallel-group, randomised,~     daily wear study. All subjects will wear the Test lens in one eye and the Control lens in~     the other eye. Data from the first four weeks of Test and Control lens exposure will be used~     for the FDA 510 (k) submission.~   "
38883|NCT02548091|"~     The purpose of this study is to determine whether Non Invasive Ventilation are effective in~     prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis~     is that administration of Non Invasive Ventilation during the procedure and systematically~     in post procedure period is a protective factor against the development and severity of~     reperfusion pulmonary edema.~   "
38438|NCT02553902|"~     OBJECTIVES:~      To evaluate the effect and cost-utility of positional therapy comparing the sleep position~     trainer (SPT) with continuous positive airway pressure (CPAP), mandibular repositioning~     appliance (MRA) and the combination SPT and MRA in patients with moderate positional~     obstructive sleep apnea (POSA).~      HYPOTHESIS:~      The SPT is more cost-effective and effective, in means of reduction of the apnea-hypopnea~     index (AHI), quality of life and compliance, compared with CPAP and MRA.~      STUDY DESIGN:~      A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12~     months per patient. Patients will be randomized for CPAP, MRA, SPT or the combination SPT~     and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.~      STUDY POPULATION:~      Patients diagnosed with moderate POSA according to polysomnography (PSG) results.~      INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:~      The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway~     pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a~     protrusive position, all to prevent effectively apneic events.~      OUTCOME MEASURES:~      AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs,~     cardiovascular parameters, incremental cost-effectiveness ratio (ICER)~      SAMPLE SIZE / DATA ANALYSIS:~      100 subjects in each treatment group, total of 400 patients.~      COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:~      The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients,~     and will save annually approximately 35-150 million euros.~   "
38439|NCT02553889|"~     Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage~     renal disease (ESRD) receiving chronic hemodialysis.~   "
38440|NCT02553876|"~     There are no studies as yet specifically investigating the application of DRG stimulation in~     the treatment of chronic pain affecting the upper limbs. The investigators propose to~     investigate the effect of dorsal root stimulation in patients with chrionic hand or upper~     limb pain.~   "
38441|NCT02553863|"~     The purpose of this study is to determine whether a course of acupuncture is effective in~     the management of peripheral neuropathy related pain in patients receiving chemotherapy.~   "
38442|NCT02553850|"~     This open non-randomized, single-arm, multicenter, observational study is designed to~     evaluate the correlation between bone turnover markers and the response to treatment in~     patients with breast cancer and bone metastases. In this observational study, ibandronate~     (Bondronat) will be prescribed and used in accordance with the standards of care. Data will~     be collected for 12 months.~   "
38443|NCT02553837|"~     This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating~     Hantavax in Healthy Adult.~   "
38444|NCT02553824|"~     This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia~     nervosa and binge eating disorder.~   "
38445|NCT02553811|"~     There is no golden universal standard for the diagnosis of Carpal Tunnel Syndrome (CTS). In~     this scenario, for a comparison of the effectiveness of the principal diagnostic tests CTS~     should determine how they affect the likelihood of disease through a clinical accuracy trial~     of good methodological quality in order to get answers to what is the best diagnostic~     strategy in clinical CTS practice. The paresthesia in nerve distribution territory median~     hands is the most common symptom in patients with CTS. The nuisance caused by paresthesia~     directly affects the quality of life of patients and impairs daily manual activities and~     sleep quality. To evaluate the remission of paresthesia is a major clinical criterion for~     improved STC being an expected relevant outcome for the patient. This study evaluates and~     compares the diagnostic accuracy of clinical examination (CE), ultrasound (US) and~     electromyography (EMG), considering the postoperative status of remission of paresthesia as~     the golden standard in the diagnosis of CTS.~   "
38446|NCT02553798|"~     This is an open-label, long-term safety study of DRM04 Topical Wipes, enrolling up to 660~     subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or~     DRM04-HH05 studies.~   "
38447|NCT02553785|"~     This study is a multi-center, prospective, single-armed, study designed to evaluate the~     safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left~     ventricular (LV) volume reduction in heart failure (HF).~   "
38448|NCT02553772|"~     This study will evaluate the safety and efficacy of a new eye drop formulation in patients~     with dry eye disease.~   "
38449|NCT02553759|"~     The aim of the present protocol is to prove if the observed actions (AOb) will improve the~     cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This~     study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and~     pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will~     consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second~     measurement (motor imagery).~   "
38450|NCT02553746|"~     The patients will be allocated to 2 groups: the ultrasound group and the palpation group.~     Ultrasound detection of the puncture site will be performed to the patients of the one group~     (group U). The puncture site will be determined by palpation of the landmarks at the~     patients of the other group (group L). The main purpose of the study is to determine if the~     ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined~     spinal-epidural anesthesia, increase the success and decrease the complication rate of these~     techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan~     can be used to determine accurately the depth of the epidural space.~   "
38451|NCT02553733|"~     In this study the investigators will test the hypothesis that short-term consumption of~     inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow~     responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients~     with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in~     the heart and skeletal muscles of patients with PAD is important because exercise triggers~     symptoms of leg pain and substantially raises blood pressure and myocardial demand in these~     patients.~   "
38452|NCT02553720|"~     The purpose of this study is to test whether addition of aquatic exercise to conventional~     treatment helps reduce the adverse outcomes of deep vein thrombosis and reduce the severity~     of chronic venous insufficiency.~   "
38547|NCT02552472|"~     This is a prospective cohort observational study of inhaler adherence in a community care~     setting (ie. general practice clinics and pharmacies in the community).~   "
38456|NCT02553668|"~     Aim of the present study is to investigate the influence of hyperoxia on the protein~     expression using the differential analysis of protein expression in tissues (proteomics). In~     the study, blood and urine samples will be collected from participants who undergo a short~     term hyperoxia using 100% oxgen for 3 hours.~      Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify~     affected proteins. Based on these results, different induction factors of proteins will be~     determined and then assessed using a bioinformatic network analysis regarding the cellular~     influence.~   "
38457|NCT02553655|"~     The investigators would like to determine if remote ischemic leg preconditioning in healthy~     volunteers improves cerebral vasomotor reactivity as measured by breath holding and~     transcranial doppler vasomotor reactivity.~   "
38458|NCT02553642|"~     The purpose of this study is to investigate the characteristics of tumors in patients~     treated with nivolumab and to identify features that help to predict a good or bad response~     to this drug.~   "
38459|NCT02553629|"~     This is a randomized control trial (RCT) that studies the surgical conditions during~     moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective~     laparoscopic surgery for bariatric surgery.~   "
38460|NCT02553616|"~     Investigators will use a Solomon 4-group design to test the effectiveness of a brief~     intervention to promote health behaviors for homeless youth who are 18-23 years of age. We~     will recruit 300 youths from Austin, TX and 300 from Columbus, OH. We will gather~     quantitative data on health behaviors and life satisfaction 3 and 6 months following the~     intervention, which will be delivered on an individual basis. Data will be analyzed using~     structural equation modeling and ANCOVA statistics.~   "
38461|NCT02553603|"~     This study is examining the effects of growth hormone releasing hormone (GHRH) on mild~     cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects~     with MCI as well as healthy controls.~   "
38462|NCT02553590|"~     To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree~     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual~     therapy in special consideration of the chosen titration schedule in everyday practice.~   "
38463|NCT02553577|"~     There has been a dramatic escalation of electronic cigarette (e-cig) use among women of~     childbearing age, including pregnant women. The overall goal of this study is to determine~     the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more~     data about these effects be available to better inform women of childbearing age.~   "
38464|NCT02553564|"~     After a hospitalization, dialysis patients have a high risk of being admitted to the~     hospital again within 30 days. The purpose of this research study is to test a new way of~     reducing the chance of patients being hospitalized again. In this study investigator will~     evaluate a checklist driven evaluation upon return to the dialysis facility as a method to~     reduce the rate of rehospitalizations in hemodialysis patients.~   "
38465|NCT02553551|"~     The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to~     reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded~     randomized controlled trial.~   "
38466|NCT02553538|"~     Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable~     populations. Most cancer PN programs are located in community health centers and focus on a~     single cancer. We will evaluate the impact of PN program on breast, cervical, and/or~     colorectal cancer screening in vulnerable patients receiving care in a large, academic,~     primary care network using a population-based IT system.~   "
38467|NCT02553525|"~     The purpose of this study is to measure the effects of non-regular temporal patterns of deep~     brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's~     disease (PD), essential tremor (ET) or multiple sclerosis (MS). These data will guide the~     design of novel stimulation patterns that may lead to more effective and reliable treatment~     with DBS. These data will also enable evaluation of current hypotheses on the mechanisms of~     action of DBS. Improving our understanding of the mechanisms of action of DBS may lead to~     full development of DBS as a treatment for Parkinson's disease and may lead to future~     applications of DBS.~   "
38468|NCT02553512|"~     The purpose of this study is to demonstrate the use of a digital health offering in the~     management of persistent hypertension during chronic anti-hypertensive treatment.~   "
38469|NCT02553499|"~     In this study, participants with advanced solid tumors will be assigned to receive either~     MK-1248 alone or in combination with pembrolizumab (MK-3475). This study will use an~     adaptive design to find and confirm the maximum tolerated dose (MTD, or maximum administered~     dose [MAD]) for MK-1248 alone and in combination with pembrolizumab.~   "
38470|NCT02553486|"~     This study evaluates the global quality of life of foreign born adopted children, one to~     seven years following their arrival in France. Investigators will assess global health,~     behavior, school integration for each child who arrived in France between 2008 and 2013,~     through an online anonymous survey. Investigators, then, will identify variables associated~     with a lower quality of life in order to improve the support offered to the children.~   "
38471|NCT02553473|"~     Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once~     daily for two weeks + placebo for four weeks. Primary objective is to answer the question~     is two weeks doxycycline treatment (currently suggested treatment) at least as effective as~     six weeks doxycycline treatment in Lyme Neuroborreliosis?.Key secondary objectives are to~     provide a better understanding of the pathogenesis and long‐term complaints, and to search~     for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and~     cerebrospinal fluid (CSF) in a biobank for future research~      Endpoints:~      Primary endpoint: Composite clinical score at six months after end of treatment.Secondary~     endpoints: Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36~     (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.~      The study design is a multicenter, non-inferiority, randomized, penta-blind,~     placebo-controlled trial. 250 patients will be included from Sørlandet Hospital and 5-10~     other Norwegian hospitals.~      Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious~     reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b)~     intrathecal Bb antibody Production and signed informed consent. Safety assessments during~     the trial: Comparison of clinical outcome six months after end of treatment between the two~     treatment groups. Subjective experiences and blood tests including hematology and~     biochemistry for four weeks after ended treatment.~   "
38472|NCT02553460|"~     The purpose of this study is to test the good and bad effects of the study drugs bortezomib~     and vorinostat when they are given in combination with chemotherapy commonly used to treat~     acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could~     decrease the number of leukemia cells, but it could also cause additional side effects.~     Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to~     treat other cancers in adults, but they have not been approved for treating children with~     leukemia. With this research, we plan to meet the following goals:~      PRIMARY OBJECTIVE:~        -  Determine the tolerability of incorporating bortezomib and vorinostat into an ALL~          chemotherapy backbone for newly diagnosed infants with ALL.~      SECONDARY OBJECTIVES:~        -  Estimate the event-free survival and overall survival of infants with ALL who are~          treated with bortezomib and vorinostat in combination with an ALL chemotherapy~          backbone.~        -  Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.~        -  Compare end of induction, end of consolidation, and end of reinduction MRD levels to~          Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant~          outcomes.~   "
38473|NCT02553447|"~     This randomized phase II trial studies how well cholecalciferol works in treating patients~     with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of~     vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D and~     improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia~     receiving standard of care chemotherapy.~   "
38474|NCT02553434|"~     After sustaining severe trauma to the chest, patients will often bleed into the chest cavity~     pleural space) which is called hemothorax or they may also experience air leakage within the~     chest cavity in combination with the bleeding (hemopneumothorax). The treatment for these~     conditions include the insertion of a tube into the chest called a chest tube). Insertion of~     the chest tube is commonly very painful for the patient due to the size or diameter of the~     tube. Alternatively, procedure it is standard practice in the acute care setting at~     Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has~     a smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The~     primary purpose of this study is to see if the use of the pigtail catheter is just as~     effective as chest tube insertion in terms of removing leaked blood and/or air from the~     chest cavity. An additional objective of this study is to evaluate which procedure is less~     painful for the patient.~   "
38475|NCT02553421|"~     This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric~     patients. Half the participants will be monitored by the device without infiltration~     notifications and the other half will be monitored by the device with infiltration~     notifications enabled.~   "
38476|NCT02553408|"~     Putting the limited use of titration algorithms in the context of escalating diabetes~     prevalence rates, strategies and tools are urgently needed to help both patients and primary~     care providers efficiently initiate and continue basal insulin therapy. Basel insulin is~     considered to be the appropriate strategy after oral diabetic agent failure. This project~     could set the stage for the need for a blood glucose meter with built-in algorithms designed~     to support decision making by patients as well as care providers. Furthermore, the project~     will evaluate the uptake and use of the newly developed Meter by Abbott Diabetes Care, which~     was launched in Canada in October 2014, and its impact on primary care diabetes~     consultation.~   "
38477|NCT02553382|"~     Despite the availability of multiple medications for the treatment of Type 2 diabetes,~     patients often continue to have difficulty attaining blood glucose targets and managing~     cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have~     created a growing public interest in dietary supplements.~      Research by this group and others support the benefits of whole grains, viscous dietary~     fibre and ginseng in the management of diabetes. The current study investigates whether the~     co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty~     acids), and 2 varieties of ginseng roots will further improve blood sugar control and~     cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving~     conventional treatments.~      Patients with Type 2 diabetes receiving the recommended intervention in accordance with the~     Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half~     of the participants will be randomly assigned to a 4-component intervention that comprises~     the co-administration of these four dietary/herbal supplements in addition to their usual~     treatment regimen; the other half will continue their usual treatment regimen in addition to~     taking high-oat fiber and wheat bran supplements.~      The investigators hypothesize that an intensified, multi-targeted intervention with the~     addition of these dietary and herb components will further improve long-term blood glucose~     control and cardiovascular disease risk factors beyond conventional therapy. If this~     combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies~     could complement current conventional therapy for Type 2 diabetes with the goal to further~     improve health outcomes.~   "
38478|NCT02553369|"~     Late 2013, the first indigenous cases of chikungunya have been observed in the French~     Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected~     by the outbreak.~      During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack~     rate was 38%. The most active period was three months.~      In this context, knowledge of the attack rate and the epidemic in the Caribbean is an~     important issue for outbreak management and modeling work.~      As the chikungunya virus had never circulated in the Caribbean, determining the~     seroconversion rate can be achieved by realizing a seroprevalence survey among the general~     population at the end of the outbreak. Another simple method is to estimate the rate in a~     cohort of patients followed regularly and whose habitat is distributed throughout the~     territory studied.~      The follow up of patients infected by the human immunodeficiency virus (HIV) in the French~     West Indies is almost exclusively performed in hospitals in department of Infectious and~     Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected~     patients on all of our territories, allow to hypothesize that the risk of transmission of~     arboviruses by exposure to mosquito bites is comparable to the general population. This~     patient cohort is well suited to study the emergence of Chikungunya in the French West Indie~     .~      Primary objective :~      To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the~     French West Indies by estimating the prevalence of specific antibodies of chikungunya virus~     in a sample (randomly constituted) from patients infected by HIV and representative of the~     general population of Martinique and Guadeloupe~      Secondary objective :~      To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied~     population To estimate the frequency of chronic forms of chikungunya in the studied~     population~   "
38479|NCT02553356|"~     This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are~     in general good health and selected for participation in the study according to the~     selection criteria. This study will assess the effect of food on the pharmacokinetics of~     PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover~     fashion.~   "
38480|NCT02553343|"~     The aim of the study is to assess the safety and immunogenicity of two formulations of the~     high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent~     influenza vaccine control in healthy elderly subjects aged 65 years of age and above.~      Primary objectives:~        -  To describe the safety profile of all subjects in each study group.~        -  To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune~          response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to~          responses induced by the licensed high-dose trivalent influenza vaccine for the 3~          common virus strains at 28 days post-vaccination.~      Secondary objectives:~        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by~          seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent~          influenza vaccine and the licensed high-dose trivalent influenza vaccine.~        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by~          GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose~          quadrivalent influenza vaccine and the investigational high-dose trivalent influenza~          vaccine.~   "
38481|NCT02553330|"~     A phase 2 study to find out if the drug INCB018424 Phosphate Cream is safe and has~     beneficial effects in people who have alopecia areata (partial or complete hair loss) when~     applied to the skin.~   "
38482|NCT02553317|"~     The study is a phase III, double blind, placebo-controlled, randomized study to evaluate the~     efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as~     measure of prevention of further microvascular thrombosis~   "
38483|NCT02553304|"~     Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western~     countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but~     slowly progressive nature history. However, the clinical course of CLL actually varies~     widely. Thus, many clinical and molecular features have been identified for outcome~     predictions. The accurate predictions of prognosis through those factors help for the~     decision making on the treatment, i.e. to treat patients of high risk of early progression~     or poor overall survival (OS) with alternative or investigational therapies, while to avoid~     unnecessary over-treatment for low-risk patients.~      CLL is much less prevalent in Eastern countries; presently, most available data on CLL are~     derived mainly from Western countries. However, a previous report concerning the~     epidemiology of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of~     CLL, a trend not found in Western countries where the incidence rate of CLL remained~     steadily stable over time. In addition to this epidemiological difference, a~     population-based analysis has found the overall outcome of CLL, estimated by relative~     survivals, is steadily much poorer in Taiwanese patients than in US Caucasians. In another~     report about the cytogenetic profiles in a small cohort of CLL patients in Taiwan, a novel~     cytogenetic abnormality was found to correlate with poorer outcomes. These reports suggest~     the existence of ethnic differences in the disease natures of CLL between the East and the~     West.~      To delineate the possible underlying racial differences, especially in the molecular~     prognostic profiles that might underlie the outcome disparity between Taiwanese and western~     CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of~     importance. In this study, we are going to enroll around 250 CLL patients; their clinical~     parameters will be recorded, their blood samples will be collected for a panel of molecular~     and cytogenetic factor studies. The molecular markers to be tested in this project include~     (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH),~     immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for~     Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor~     (SCF). These proposed markers include not only the conventional prognostic markers derived~     from Western studies, and also some novel explorations from our preliminary results, such as~     SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be~     established to identify the characteristics of CLL in Taiwanese patients and to address the~     underlying factors of ethnic differences in the disease nature and outcomes of this disease.~   "
38484|NCT02553291|"~     HIV was once a fatal diagnosis, but due to treatment advances it is no longer a death~     sentence. Today, HIV-infected adults face a new challenge to their health; they are~     developing cardiovascular disease (CVD) earlier and more frequently than those not~     HIV-infected. Reasons for this include toxic effects of HIV medications and activation of~     the immune system. Preventing cardiovascular disease in HIV-infected adults will help them~     live healthier lives; however, there is a lack evidence to help us to achieve this goal.~     Exercise prevents cardiovascular disease, but it is often not addressed in HIV care, due, in~     part, to a lack of practical interventions targeting this population. This study will~     address this problem by testing an intervention to improve and maintain exercise in~     HIV-infected adults.~      This study will examine the impact of an innovative and sustainable intervention, adapted to~     the unique medical and psychosocial needs of HIV-infected adults, called SystemCHANGE-HIV.~     It consists of six sessions to help redesign an individual's environment and routines to~     increase exercise.This is a randomized trial in which half of the subjects will participate~     in the intervention and half will participate in a control condition. Measures include~     assessments of exercise, fitness, and the markers of cardiovascular health before and after~     the intervention to see if, and how, they changed.~   "
38485|NCT02553278|"~     Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I~     V3 device for non-invasive fat reduction vs. control.~      All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with~     VelaShape or Contour I V3 device.~      Each arm will be treated with a different device:~      Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I~     V3 device~   "
38486|NCT02553265|"~     The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well~     tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension~     and normalize or reduce the exaggerated blood pressure variability in patients with familial~     dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or~     Riley-Day syndrome). Funding Source- FDA OOPD.~   "
38487|NCT02553252|"~     Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week~     intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control~     (WLC) to assess the effects of this intervention on symptoms of PTSD, depression, anxiety,~     quality of life, autonomic symptoms, and blood inflammatory markers.~   "
38488|NCT02553239|"~     This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle~     tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed~     CoolLoop® cryoablation catheter.~      A further aim of the investigation is the evaluation of the efficacy and average duration of~     the applied procedure.~   "
38548|NCT02552459|"~     The purpose of this study is to determine effect of combined medication of sufentanil and~     dexmedetomidine in patient controlled analgesia after neurosurgery.~   "
38549|NCT02552446|"~     Indirect calorimetry is the gold standard to measure energy expenditure. In fact it is not~     always available and inconstantly feasible. Various equations for predicting energy~     expenditure based on body weights have been created. This study aims at determining the best~     suitable predictive strategy unless indirect calorimetry is available.~   "
38489|NCT02553226|"~     Background:~      The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce~     labour. The hypothesis to be studied is that once the active phase of labour has commenced,~     Syntocinon® can be discontinued and the labour process will continue.~      Design:~      Double-blind randomised controlled multicentre trial~      Setting:~      Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark~      Population:~      1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for~     induction~      Methods:~      The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo)~     or Syntocinon® infusion (control group), when the active phase of labour is reached.~      Main outcome measures:~      Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience~      Perspective:~      Syntocinon® is on the list high-alert medications and associated with complications for~     mother and child during labour. Reducing the duration of stimulation during labour may lower~     the number of asphyxial sequelae and the number of caesarean sections.~   "
38490|NCT02553213|"~     The aim of the study is to investigate, if bariatric surgery or the related caloric~     restriction causes the significant improvement of glucose metabolism, which has been found~     in bariatric patients.~   "
38491|NCT02553200|"~     The efficacy of breathing exercise with oscillated inspiratory loading and oscillated~     positive expiratory pressure for airway secretion clearance and lung function in intubated~     patients, both with and without mechanical ventilation dependence~   "
38492|NCT02553187|"~     The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the~     treatment of patients with late-stage cancer cachexia.~   "
38493|NCT02553174|"~     The study will investigate the role of NSAIDs in the development of AKI in patients~     undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the~     use of new urinary biomarkers will allow earlier detection of AKI than the current gold~     standard, i.e. changes in serum creatinine and/or urine output.~   "
38494|NCT02553161|"~     A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with~     depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be~     evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a~     MRI scan and then randomized to treatment. Following randomization, high-risk youth will~     have visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks~     during which time tolerability and ratings will be performed. MRI scan will be repeated at~     week 4.~   "
38495|NCT02553148|"~     A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used~     to estimate the global need for palliative care for children aged 0-19 years. Prevalence~     data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic~     groups needing children's palliative care according to WHO and UNICEF guidelines.~   "
38496|NCT02553135|"~     Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The~     study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients~     will be required to attend a total of 11 study visits over a 24 month period with an~     additional 3 year follow-up.~   "
38497|NCT02553122|"~     Total knee arthroplasty is a surgical procedure that involves a significant amount of blood~     loss and it has always been the surgeons' goal to try to minimize blood loss. In the current~     study, we will investigate the effect of blood loss after total knee arthroplasty with the~     combination of Evicel, a fibrin sealant and Tranexamic Acid.~   "
38498|NCT02553109|"~     The optimal consensus concerning treatment of incidental small paraclinoid unruptured~     intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to~     reveal the natural history of small paraclinoid UIAs with the goal of informing the~     treatment plan.~   "
38499|NCT02553096|"~     Aim is to test the effect of ACCESS (Adaptive Computerized COPD Exacerbation~     Self-management Support), a software application designed to support patients with COPD in~     self-management of exacerbations.~   "
38500|NCT02553083|"~     The investigators will performed a large-scale multi center trial to compare the efficacy of~     a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300)~     patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and~     Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to~     symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80~     years old will be excluded. All patients will be naive to eradication therapy and will be~     randomized into one of three groups:~      Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg~     and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin~     500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).~      All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim~     of the study is to assess eradication success, intentioned to treat and per protocol in the~     three treatment regimens.~      The secondary aim of the study is to assess the safety of high dose amoxicillin and~     doxycycline.~   "
38501|NCT02553070|"~     Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to~     the Emergency Department or Health Care Facility which can result in crowding of Emergency~     Departments, unnecessary utilization of valuable health care resources, unnecessary~     treatments, and or mistakes / errors resulting in harm to the patient.~      Inaccurate perceptions about the severity of an exposure can result in delays in proper~     evaluation and treatment resulting in harm or in some cases death of the patient.~   "
38502|NCT02553057|"~     Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury.~     Since lung protective ventilation has been recommended during anesthesia to prevent ongoing~     lung injury, so in our study the investigators will compare three different lung protective~     strategies regarding their lung protective effect measured by the incidence of postoperative~     pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator~     release.~   "
38550|NCT02552433|"~     The objective of this study is to describe the wound related complication rate in~     post-bariatric body contouring surgery patients who are treated according to the new Dutch~     guideline and to asses the factors associated with a higher complication rate.~   "
38551|NCT02552420|"~     The purpose of this study is to determine the effectiveness of infrared thermal imaging in~     adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).~   "
38503|NCT02553044|"~     Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some~     debate as to whether total 25(OH)D is the best marker to use.~      It has been suggested that free vitamin D may be better because it may be more biologically~     available.~      There are also some uncertainties about how we treat vitamin D deficiency. A single dose is~     attractive because it is certain that the patient has had the dose and there is no~     requirement for ongoing compliance, but it is still not clear what the best dose is to give.~     Also, recent studies have highlighted that high dose vitamin D supplementation may increase~     the risk of falling in older populations.~      The investigators believe that studying how free vitamin D responds to different bolus doses~     is the best way address some of the current research gaps, including what is the best~     biomarker of vitamin D status, what is the mechanism of vitamin D toxicity and what is a~     safe bolus dose to treat deficiency.~      The investigators will study changes in total and free 25(OH)D, and also clinical response,~     to three different bolus doses of vitamin D (50 000IU, 150 000IU and 500 000IU) in 84~     vitamin D deficient postmenopausal women, over a three month period with 5 study visits. A~     concurrent control group of 28 vitamin D sufficient postmenopausal women will also be~     recruited.~      This will allow the investigators to determine how total and free vitamin D change with~     bolus dosing and whether there is a disproportionate rise in free 25(OH)D with higher doses~     that may lead to hypercalcemia and falls.~   "
38504|NCT02553031|"~     This study will explore the potential value in proper therapeutic decision and clinical~     outcome prediction by using integrated MR-PET system and advanced MR techniques in patients~     with colorectal cancer.~   "
38505|NCT02553018|"~     The primary objective of the study is to compare, in patients treated with methotrexate~     injection for rheumatoid arthritis, the compliance and the health assessment questionnaire~     evolution for the administration by auto-injector versus administration by conventional~     subcutaneous injection, after 6 months of treatment.~   "
38506|NCT02553005|"~     Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by functional~     disability and pain. Although acupuncture is widely used, western acupuncture studies on RA~     show no conclusive positive result. Acupuncture is regarded as a reflex therapy, and~     Traditional Chinese Medicine (TCM) diagnosis was shown to be an individual neurovegetative~     state allowing to individually allocated acupoints. Positive results were reported using a~     classical diagnostic procedure to allocate acupoints to the patient according to the Shang~     Han Lun. The investigators are interested if acupuncture compatible with this ancient theory~     would be successful in improve hand function in RA patients.~      The investigators therefore developed a prospective randomized control trial in a~     three-armed parallel group design with a standardized treatment intervention. Only patients~     with the TCM diagnosis of a so-called Turning Point syndrome will be allowed in the~     experimental phase. This may harmonize TCM diagnosis and the standardized intervention, in~     order to optimize potential therapeutic effects.~   "
38507|NCT02552992|"~     This study is a pilot, randomized controlled trial to provide feasibility and conduct~     preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga~     intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have~     demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga~     classes are available to the public and a specialized yoga protocol for individuals with~     cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better~     understand how these potential physical mechanisms specifically lead to improvement in~     pain-related outcomes including pain and disability. This knowledge will be used to design a~     large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will~     be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will~     receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga~     intervention will be offered weekly yoga classes and instructional materials will be~     provided for home practice.~   "
38508|NCT02552979|"~     Positive reactions in atopy patch test in children with atopic dermatitis.~   "
38509|NCT02552966|"~     It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict~     passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist~     Device (UESAD) is a novel device that applies relatively modest external cricoid pressure,~     which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic~     enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients~     with reflux associated laryngeal symptoms and implicated in the pathogenesis of~     laryngopharyngeal reflux. This study will asses the effectiveness of a UESAD worn for 2~     weeks on LPR symptoms and salivary pepsin levels.~   "
38510|NCT02552953|"~     This is an open-label, single arm, dose escalation study in patients with advanced cancers.~   "
38511|NCT02552940|"~     This observational trial will evaluate the effectiveness, the consistency of evaluation~     scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in~     participants with RA in daily clinical practice.~   "
38512|NCT02552927|"~     Infants will be randomized to either chest shielding with aluminum foil or chest shielding~     without aluminum foil while undergoing phototherapy for premature infants. The primary~     outcome is patent ductus arteriosus.~   "
38513|NCT02552914|"~     Study objectives:~        -  To evaluate the usability of the Colli-PeeTM device to collect first-void urine for~          nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas~          vaginalis and Mycoplasma genitalium.~        -  To collect feedback on the easiness of use and the willingness of future use of the~          Colli-PeeTM device.~   "
38514|NCT02552901|"~     Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value~     (PDR) to assess liver function in normal patients as well as in patients with mild to severe~     hepatic impairment compared to manual Serum ICG PDR.~   "
38515|NCT02552888|"~     The proposed randomized controlled trial will test the safety and efficacy of combination~     therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among~     patients with chronic kidney disease.~   "
38552|NCT02552407|"~     During primary percutaneous coronary intervention, distal embolization of thrombus and~     impaired microvascular perfusion has been associated with an increased mortality.~     Thrombectomy devices during primary percutaneous coronary intervention may prevent distal~     embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce~     mortality.~   "
38516|NCT02552875|"~     Repetitive nerve stimulation is used to monitor the neuromuscular transmission function in~     infants, children and adults after the application of muscle relaxants. During repetitive~     stimulation of a motor nerve, amplitude of contractions of the corresponding muscle will~     increase to a plateau (twitch potentiation), which is known as the staircase phenomenon.~      There is no systematic information about the staircase phenomenon of the adductor pollices~     muscle (ulnar nerve) in children between 1 month and 18 years .~      In adults , a 50-Hz tetanus administered before initial twitch stabilization is able to~     shorten the twitch stabilization period and to eliminate this staircase phenomenon.~      The purpose of this study is to investigate the characteristics of twitch potentiation in~     children between 1 month and 18 years by using acceleromyography.~      In addition we investigate whether application of a 50-Hz tetanic stimulation is able to~     eliminate the twitch potentiation like in adults.~   "
38517|NCT02552862|"~     Study Design: Double-blind placebo-controlled clinical trial~      Study Duration:2 years~      Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)~      Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in~     patients with cirrhosis and SBP~      Number of Subjects: 30~      Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at~     Hospital de la Santa Creu i Sant Pau~      Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2~     every 12 hours during hospitalization (n=15), or placebo (n=15)~      Duration of administration: During hospitalization due to SBP episode~      Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could~     decrease bacterial translocation and systemic and cerebral proinflammatory state. This would~     result in a faster SBP resolution, a decrease in the incidence of complications and an~     improvement in cognitive function.~   "
38518|NCT02552849|"~     This is a multi-center, non-interventional study to assess and describe course and outcomes~     in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet~     (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity~     (FVC) change from baseline on an ongoing basis.~   "
38519|NCT02552836|"~     The primary aim of this randomized controlled trial is to determine the acute antidepressant~     efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson`s~     Disease.~   "
38520|NCT02552823|"~     Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011).~     Lifestyle modifications that include a diet high in fibre may lower the risk of developing~     type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich~     foods has been widely recognized for its effect on post-prandial glucose response (PPGR).~     Peas are high in fibre and protein and show great potential as a functional food. A health~     claim for PPGR would increase market demand for peas, and help those who want to limit the~     rise in blood sugar after a meal choose products to meet their goals, but there are several~     gaps in the literature that need to be filled before a submission to Health Canada can be~     successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin~     response; 3) test varieties of peas that that currently available on the market; 4) test~     whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy~     reference food (rice or potato). The proposed study design will address all of these gaps in~     the current literature and take into consideration Health Canada's guidance document for~     health claims related to the reduction in PPGR, which sets out the criteria by which the~     validity of such claims will be assessed.~      Specific objectives~        1. To determine the effect of 3 common market classes of peas on PPGR and insulin response~          in a cross-over, randomized, controlled clinical trial.~        2. To assess the effect of 3 common market classes of peas on appetite-related sensations~          using visual analog scales.~        3. To demonstrate whether the test and reference products were liked or disliked similarly~          by participants.~        4. To assess any gastrointestinal side effects from eating the test products~   "
38521|NCT02552810|"~     Contamination of implant abutments could potentially influence the peri-implant tissue~     inflammatory response. The aim of the present study was to assess the radiographic bone~     changes around customized, platform switched, abutments placed according to the~     one-abutment-one-time protocol, with and without plasma of argon cleaning treatment.~   "
38522|NCT02552797|"~     Patients should be able to have a say in their care and treatment, but how this should work~     for children and young people with mental health difficulties is unknown. For example, how~     and when do young people want to be involved in decision making, and what is important to~     them, their parents/guardians and healthcare professionals? This project will address these~     questions and will develop a tool known as 'Power Up' to help young people with mental~     health difficulties make decisions about their own care and treatment.~      This project will run for 24 months and will:~        1. Understand the beliefs, experiences, and values of young people, their~          parents/guardians and clinicians around shared decision making (SDM) in mental health.~        2. Use these responses to develop 'Power Up'; a tool to help young people make decisions~          about their care or treatment in mental health services.~        3. Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number~          of patients who would want to use Power Up and to see whether patients can be recruited~          and followed up with measures. The pilot study would investigate randomisation, see how~          clinicians cooperate, and identify barriers to collaboration and ways of overcoming~          these.~      Forty five young people, parents and clinicians will be recruited for interviews and focus~     groups to inform tool development. Sixty young people aged 1116 will be recruited for the~     pilot/feasibility study. Measurements will be collected at baseline, session by session, and~     at the end of treatment.~   "
38523|NCT02552784|"~     The general objective is study medical, socioeconomic, behavioral, health environmental,~     school and professional integration, and short- and medium- term quality of life~     determinants for all patients under 18 years old, residing in France for which the diagnosis~     of inherited metabolic diseases with specific regime (MHMRS) has been achieved during their~     childhood.~   "
38524|NCT02552771|"~     Multicentre, double-armed, randomized controlled trial designed to compare mitral valve~     leaflet resection versus leaflet preservation with regards to the development of functional~     mitral stenosis following surgical repair of mitral valve prolapse. Patients will be~     randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral~     valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed~     by echocardiographic and clinical assessment at 12-months following surgery.~   "
38525|NCT02552758|"~     Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior~     of the schizophrenia patients. Investigators will use PET to explore the influence on~     serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works.~     This study will enroll 100 patients of schizophrenia with violent behavior.Participants will~     be split into two groups randomly. In one group, participants will receive one pill of~     placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty~     acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12,~     some scales will be evaluated. Meanwhile, the density of eicosapentaenoic~     acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in~     blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly~     selected to have the exam of PET.~   "
38526|NCT02552745|"~     This study is aiming to understand the effects of parecoxib on the postoperative~     complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter~     arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed~     with HCC for the first time and who received hepatic TACE at the Cancer Prevention and~     Treatment Center of Sun Yat-sen University from October 2014 to March 2015 were~     prospectively enrolled. The patients were divided into study and control groups according to~     whether parecoxib sodium was administered postoperatively. Pain scores,body temperature,~     vomiting, and changes in liver function after surgery, as well as the length of the hospital~     stay, were recorded and compared.~   "
38527|NCT02552732|"~     The aim of this feasibility study is to provide data for a subsequent randomized controlled~     trial to investigate if patient outcomes will be improved after an acute COPD exacerbation~     using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility~     study will investigate the following: process, resources, management and scientific aspects~     of delivering NHF as an adjunct therapy in COPD patients.~   "
38528|NCT02552719|"~     Purpose of the study is the validation of the German version of the Injustice Experience~     Questionnaire.~      Pretest: Participants were informed about the aims of the study and fill in a consent form.~     They filled in a paper version of the German translation of the Injustice Experience~     Questionnaire. In a structured interview patients were asked if there were any items~     difficult to understand, unacceptable or offending them. Subsequently they had to answer~     questions about the content and meaning of the IEQ-items.~      Validation Study: Participants were informed about the aims of the study and filled in a~     consent form. By e-mail they received an access link to the online survey. The~     questionnaires of the survey could be filled in at home. The survey could be interrupted and~     terminated later. About 20 minutes were needed to answer the 80 questions of the survey. All~     data was saved anonymously during the survey.~   "
38529|NCT02552706|"~     The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture~     probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight~     infants.~   "
38530|NCT02552693|"~     This study evaluates the effectiveness of an enhanced package of support for activities~     described in the Standard Operating Procedures (SOP) for Patient Tracing in Health~     Facilities in Zimbabwe. This package is intended to increase the effectiveness of active~     patient tracing activities by developing tools, providing mentorship and implementing~     systematic review of processes to improve communication, coordination, and supervision~     between community health workers and facility-based staff.~   "
38531|NCT02552680|"~     Introduction: Work-Related Musculoskeletal Disorders (WMSDs) are characterized by~     inflammation of muscles, tendons, fascia and nerves of upper limbs, shoulder girdle and~     neck. Its incidence is increasing and there is evidence of its association with the pace of~     work. As WMSDs, another major public health problem is back pain, which also negatively~     influence the quality of life of patients. These diseases affect many workers, among them,~     workers in the health area, including surgeons. Studies show that many surgeons are~     suffering from fatigue and musculoskeletal pain after undergoing surgery, especially~     laparoscopy. Regarding the quality of life of doctors, a study indicates that surgeons have~     commitment of domains Vitality and Pain. For these reasons it is important to develop~     strategies for prevention of occupational risks (WMSDs) in this class of workers.~      Objectives: To evaluate the influence of a Preventive Program (educational and gymnastics)~     for prevention of WMSDs, in the quality of life, in limitation of the work, in intensity and~     frequency of musculoskeletal pain in surgeons of the Hospital de Clínicas de Porto Alegre.~     There will also be evaluated the effects of the program on muscular strength and flexibility~     of medics participating in the Preventive Program.~      Methodology: Randomized clinical trial with a sample of 54 surgeons, divided into two~     groups: A (Intervention: will participate in eight meetings consisting of exercise and~     guidelines on care and prevention of WMSDs in activities of daily living, especially those~     relating work activities) and B (Control: will receive a manual-brochure - containing~     information about general health). Participants will sign a Letter of Consent.~   "
38532|NCT02552667|"~     Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled,~     multicenter phase 3 clinical trial.~   "
38533|NCT02552654|"~     Intrusive memories of traumatic events are core features of posttraumatic stress disorder~     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of~     this study was to determine whether cortisol levels during an intrusion-inducing stressor~     influence subsequent intrusive memories.~   "
38534|NCT02552641|"~     The purpose of the study is assess whether the various forms of triple regimen of~     administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and~     any independent mealtime) influence the rate of eradication of this bacterium.~   "
38597|NCT02551822|"~     The investigators objective is to compare patient outcomes as changes in validated symptom~     measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF)~     symptom scale, between women who are set on cycling versus continuous programs for their~     neuromodulator. Specifically, the investigators propose to perform a randomized double blind~     crossover study in women who are successfully treated with neuromodulation to either~     continuous or cycling mode on the modulator and compare differences between groups on the~     validated OABq-SF symptom questionnaire. In addition, the investigators will compare~     differences in urinary frequency and pad counts between women randomized to cycling versus~     continuous stimulation as measured by a 3 day voiding diary. This investigation will provide~     evidence-based guidelines for neuromodulator programming.~   "
38535|NCT02552628|"~     Dystonia in Wilson's disease represent a major issue. The persistence of disabling motor~     symptoms despite medical treatments justifies conducting a study on deep brain stimulation~     (DBS) in Wilson's disease (WD). For bradykinetic patients, subthalamic nucleus (STN) could~     be considered as a better target than the globus pallidus (GPi). For patients with~     hyperkinetic dystonia, the internal globus pallidus (GPi) will be chosen as the target of~     DBS.~      The investigators hypothesize that STN DBS will improve Wilson's disease patients, who,~     despite copper chelators drugs, are still impaired by severe dystonia and akinesia (more or~     less associated with other movement disorders).~      The investigators primary objective is to demonstrate the efficacy of STN/GPi DBS on~     dystonia associated with Wilson's disease.~      Secondary objectives:~        -  To evaluate the impact of STN/GPi DBS on other movements disorders (tremor,~          Parkinsonism, chorea) observed in Wilson's disease.~        -  To describe cognitive status of patients and to evaluate the consequences of STN/GPi~          DBS on cognition and behavioral aspects of the disease.~        -  To evaluate the consequences of the stimulation on speech and swallowing.~        -  To evaluate the social impact of STN/GPi DBS in Wilson's disease.~        -  To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease.~   "
38536|NCT02552615|"~     The aim of this study was to compare the effects of spinal stabilization and body awareness~     in addition to brace wearing versus classical exercises on subjective verticality~     perception, trunk symmetry and quality of life in AIS. Study included 30 AIS patients~     between the ages of 14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and~     13.60±1.65 (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and~     haptic (SHV) and deformity perception, quality of life were assessed at baseline and after~     10th week of treatment. Cobb angle decreased in stabilization and awareness groups. Rotation~     decreased in three groups. SVV improved in all groups. SPV and SHV, body asymmetry and~     cosmetic deformity improved in stabilization and awareness groups. Only function improved~     with stabilization treatment. Stabilization and body awareness exercises created positive~     changes in AIS.~   "
38537|NCT02552602|"~     Micronutrient deficiencies in people living with HIV have been reported. Multivitamins can~     address micronutrient deficiencies, however the benefits of multivitamins in people living~     with HIV is still debatable. While some multivitamin intervention studies have reported the~     benefits of multivitamins in HIV infection, some other studies have reported no statistical~     differences in outcomes of interest in intervention and control groups. With clear~     differences in composition and strength of the multivitamins used in the different studies,~     it is possible that some of the multivitamins used in some of the intervention studies may~     have been unable to meet existing micronutrient deficiencies. Hence there is a chance that~     higher strength multivitamins may be better able to correct these deficiencies and result in~     better outcomes. This study will therefore compare three different multivitamins varying in~     strength and composition to determine if any one of the three multivitamins will produce~     better health outcomes.~   "
38538|NCT02552589|"~     The purpose of this double blind study is to prove whether a fluoride containing toothpaste~     is able to reduce dental plaque and gingival inflammation in patients who have gingivitis~     when applied twice daily during brushing at home over a period of 12 weeks.~   "
38539|NCT02552576|"~     This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further~     investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease~     (VWD) in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand~     therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento~     either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic~     bleeding event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a~     dose prescribed by the Investigator in accordance with the Voncento Summary of Product~     Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a~     frequency of 1-3 times per week). Voncento will also be given to prevent and treat any~     surgical bleeding events.~   "
38540|NCT02552563|"~     This pilot study seeks to examine the extent to which, relative to usual care, a dementia~     care management program for veterans and their caregivers (CGs)improves patient (e.g.,~     behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery,~     burden, affect) outcomes.~   "
38541|NCT02552550|"~     The curative treatment and organ preservation in advanced squamous cell carcinoma of the~     oropharynx is multimodal. It involves induction chemotherapy and depending on the response~     radio-chemotherapy or surgery. The combination of these methods has important functional~     consequences.~      The aim of this prospective pilot study is to describe swallowing, speech, but also~     patients' quality of life before and after therapeutic management (existing studies~     measuring these functions after treatment but not before).~   "
38542|NCT02552537|"~     In patients with a walnut allergy double blind placebo controlled food challenge with walnut~     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess~     the impact of PPI on threshold level and on clinical manifestation.~   "
38543|NCT02552524|"~     The gambling problem is characterized by a loss of control and an excessive focus on the~     gambling practice. Currently, the treatment of pathological gamblers is often complex and~     multidimensional, it notably includes psychological techniques including cognitive~     behavioral therapy and the use of psychotropic drugs.~      In pathological gambling and addictions, craving (or urge to play) and loss of control are~     two essential clinical elements. The neurobiological level, they are associated with a~     dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and~     Goldstein, 2002).~      One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation~     (rTMS).~   "
38544|NCT02552511|"~     A Multicentre, observational and cohort study to get the incidence of new-onset or~     newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain~     electric activity and diagnose. Other data also will be collected since first seizure until~     confirmed diagnosis.~   "
38545|NCT02552498|"~     Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the~     gingiva in order to characterize the kinetics of the blood flow changes in human subjects.~   "
38546|NCT02552485|"~     Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension~     in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as~     latest clinical control ≥ 5 years.~   "
38553|NCT02552394|"~     This clinical trial is for men with advanced prostate cancer that may have spread to other~     parts of the body.~      Currently, once prostate cancer cells have spread from the prostate to other organs it is~     not treatable by surgery. The purpose of this study is to treat patients with an~     experimental antibody (i.e. that has not been FDA approved) called J591 that attaches itself~     to a special protein on cancer cells called PSMA to try to eliminate these cancer cells~     (called circulating tumor cells) from the circulation.~      In the initial phase of the study, 6 participants will receive the experimental J591~     treatment. Routine blood tests, research blood tests, physical exam will be performed at~     each visit. Participants will also be asked to complete a questionnaire about how they are~     feeling. Participants will have a radiographic scan every 3 months to check the status of~     their disease.~      Participants who tolerate the treatment well may be re-treated at the same level every 3~     months, and may continue on treatment as long as they are responding to therapy and not~     experiencing unacceptable side effects.~   "
38554|NCT02552381|"~     The purpose of the study is to assess the fibrin structure marker in the plasma of cancer~     patients, treated or not treated with LMWH at therapeutic doses, in order to determine the~     venous thromboembolic risk. The occurrence of thromboembolic events in patients without~     treatment and in patients under LMWH treatment at therapeutic doses will be recorded,~     depending on the location and type of cancer, metastases, and treatment of cancer.~   "
38555|NCT02552368|"~     The ultimate goal of this project is to develop a functioning and clinically feasible method~     for restoring function to motor-impaired stroke survivors. This ultimate goal will be~     approached through two different means. The first method is to develop a functioning~     brain-computer interface that operates based on cortical activity ipsilateral to an intended~     movement on the motor-impaired side of the body. And secondly, to develop new methods of~     rehabilitation that involve stimulating peripheral muscles based upon cortical activity~     ipsilateral to intended movements. Finally, the study seeks to assess changes in functional~     connectivity as a result of using a BCI device.~   "
38556|NCT02552355|"~     The investigators propose that post-exercise milk protein feeding will enhance the~     mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In~     addition, the investigators propose that this stimulatory effect of protein feeding will~     overcome the potential blunting effect of metformin on exercise responses. The investigators~     will investigate these outcomes over a 12-week exercise-training program in older adults~     with pre-diabetes with or without metformin treatment.~   "
38557|NCT02552342|"~     The purpose of the present study is to assess the efficacy of methylprednisolone as an~     adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).~      The hypothesis of the study is that methylprednisolone can decrease the mortality of severe~     CAP without any significant side effects,with reduction of the time to clinical stability~     and failure rate of treatment.~   "
38558|NCT02552329|"~     Most research on Tai Chi has been done in the area of balance and falls. Studies examining~     the effects of Tai Chi exercise on cognitive function are sparse especially in the~     population of MCI. Therefore, the aims of the present study are: 1) to examine the effects~     of Tai Chi exercise on cognitive function of elderly with MCI, and 2) to investigate the~     effects of 6-month Tai Chi exercise on serum biomarkers in individuals with MCI.~   "
38559|NCT02552316|"~     The ASPIRE study is a clinical trial designed to examine the microbes (e.g., bacteria)~     within psoriasis skin lesions compared with normal skin. The investigators will also examine~     the effect of NB-UVB (narrow-band ultraviolet B) phototherapy (i.e., light therapy) on skin~     microbes.~   "
38560|NCT02552303|"~     The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination~     of the two on the sleep continuity of persons suffering from sleep disordered breathing and~     their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed~     with obstructive sleep apnea and who meet additional research and diagnostic criteria for~     insomnia will be recruited. Participants will submit daily sleep diaries and supplemental~     questionnaires as measures of study progress.~   "
38561|NCT02552290|"~     The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation~     and passive stretching to the upper trapezius on pressure pain thresholds and range of~     motion (ROM) in individuals without recent complain of neck pain.~   "
38562|NCT02552277|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in~     subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately~     24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10^6~     cells), PDA-002 (30 x 10^6 cells), or placebo (vehicle control) in a 1:1:1 randomization~     approach. Investigational product or placebo will be administered monthly (3 administrations~     total on Study Days 1, 29, and 57).~   "
38563|NCT02552264|"~     The Behaviour Change Institute (BCI) was created in 2008 within Capital Health to provide~     healthcare providers with evidence-based skills in helping patients change. In addition, the~     BCI has also become a resource within the organization to assist with other needed changes,~     such as helping healthcare providers use new or different procedures to provide better~     patient care. Through our work at the BCI we have identified the need to help healthcare~     providers to better cope with change. The purpose of this project is to implement and to~     evaluate an evidence-based professional resiliency training program for staff to help them~     better cope with change. This professional resiliency training program is based on an~     empirically supported form of therapy called Acceptance and Commitment Therapy. The training~     takes the form of a hands-on, applied workshop designed to increase resiliency and~     flexibility in a workplace setting.~   "
38598|NCT02551809|"~     The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine~     (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and~     immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the~     secondary endpoint.~   "
38599|NCT02551796|"~     To evaluate the short-term changes in ocular surface measures and tear inflammatory~     mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and~     femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.~   "
38901|NCT02547857|"~     Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for~     ovarian pathology, though its use has not been described in the medical literature. This~     observational study aims to describe its use in clinical ED practice.~   "
38564|NCT02552251|"~     Congenital adrenal hyperplasia (CAH) results from a deficiency of a key enzyme in the~     biosynthesis of cortisol, mainly 21-hydroxylase, resulting in its classic form a neonatal~     salt loss syndrome and / or a virilization syndrome in girls. The treatment of the disorder~     in adulthood involves administering steroidal compounds with the aim to substitute the~     gluco- and mineralocorticoid deficit on the one hand, and effectively curb the adrenal~     hyperplasia and adrenal androgen pathway in girls . The terms of glucocorticoid treatment~     are not clearly codified and are based on several steroidal compounds and various protocols.~     The advantages in terms of adrenal suppression and disadvantages - including bone and~     metabolic - different treatments have not been clearly established in the literature. The~     main objective of this study is to compare among adults with HCS in its classical form the~     impact on hormonal parameters adrenal suppression glucocorticoid of 3 types of treatment~     administered to equivalent dose and according to the usual procedures. The secondary~     objective is to compare in the same patients the impact of different drugs and treatments on~     several metabolic bone parameters. The study will include 40 adult patients bearing a HCS in~     its classical form and will include 3 treatment sequences of eight weeks each, during which~     they will be administered sequentially in random order at random and according to the known~     equivalences hydrocortisone, prednisone (CORTANCYL) and dexamethasone (DECTANCYL).~      Randomization will be stratified based on previous DMARDs in the investigation that may be~     different for different patients, knowing that France hydrocortisone and dexamethasone are~     used mainly for the treatment of congenital adrenal hyperplasia. The judging criteria will~     be: i) the criteria of adrenal hormone suppression: plasma levels of testosterone,~     androstenedione, 17 OHP, ACTH and diurnal variations of the 17 OH progesterone salivary ii)~     the criteria of the metabolic impact of glucocorticoids: plasma glucose levels , blood~     lipids, and insulin sensitivity index HOMA-R calculated from glucose and insulin, iii) the~     criteria of bone impact of glucocorticoids: plasma for CTX bone resorption and bone alkaline~     phosphatase P1NP for bone formation iv) the living quality criteria evaluated by the PGWB~     Questionnaire (Psychological General Well-Being). The duration of the study period will be~     24 months.~   "
38565|NCT02552238|"~     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced~     dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial~     border delineation (LV EBD) at rest and who are scheduled for coronary angiography.~   "
38566|NCT02552225|"~     The study will compare the effectiveness of amitriptyline versus placebo (inactive~     medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned~     at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be~     seen in the clinic at baseline and at 8 weeks. Improvement will be measured using~     standardized symptom scales, and a self-reported subjective improvement percentage.~   "
38567|NCT02552212|"~     Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing~     Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab~     pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the~     efficacy of CZP in these patients.~   "
38568|NCT02552199|"~     To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria~     for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.~   "
38569|NCT02552186|"~     Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical~     repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to~     classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest,~     usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the~     necessary measurements. However, CT delivers a high dose of ionizing radiation, which~     carries cumulative long-term risks of malignancy and MRI can be costly. The purpose of this~     study is to develop a method whereby accurate chest wall measurements can be obtained to~     quantify PE severity without the need for cross-sectional imaging.~   "
38570|NCT02552173|"~     Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in~     40consecutive total hip arthroplasties.~   "
38571|NCT02552160|"~     Prospective, multi-centre, non-interventional study to collect findings about the effects of~     LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination~     preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life~     under real conditions and to find out what types of patients are selected for this therapy~     by physicians.~   "
38572|NCT02552147|"~     Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or~     aggression, which can interfere with functioning. The purpose of this pilot study is to test~     whether transdermal nicotine is effective for irritability and/or aggression in adults with~     ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in~     three visits. At the first visit, subjects are screened for eligibility and enrolled.~     Baseline measures include rating scales and a frustrative computerized task. They will then~     wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study~     measures are repeated, vital signs and side effects monitored. Subjects will return for a~     third and final visit on day 21 to repeat the study measures performed during visit two.~   "
38573|NCT02552134|"~     Background: More than 10% of the adult population in Styria, a federal state in the south of~     Austria, is allotted to a stationary stay at a health resort each year. In practice~     approximately 50.000 adults receive these stays that are financed from the health insurance~     companies and that last up to 3 weeks. The target group for theses stays is the general~     population aged between 30 and 65 years that shows minor health deficits like back pain or~     risk factors for cardio-metabolic diseases. The treatment during the stays consists of~     exercise, nutritional and psychological interventions. Thus the increase of physical~     activity is an important goal that is focussed during the stationary stay. Because of the~     absence of regional facilities that are linked to the resorts and that provide accesses to~     standardised regional programmes sustainability is questionable.~      Methods/Design: This prospective controlled open label study compares two study groups.~     After a stationary stay at a health resort patient are allocated to a standardised, regional~     sports-club based exercise programme or to another group, where only written hand-outs are~     provided. The primary outcome is the weekly level of health enhancing physical activity~     which is objectively measured with an accelerometer and an activity log-book. Additionally,~     social determinants are requested, fitness and anthropometric measurements are done at~     baseline until 12 months. Beside the changes in measurable parameters, processes are~     evaluated accurately. Consequently the gateway - function of the health resort is analysed.~      Discussion: The structured cooperation between the health sector, where health resorts~     informing and assigning patients to regional sports-clubs and the sports sector potentially~     provides a wide network of standardised programmes. Within this study we aim to evaluate the~     sustainability of stationary stays and a continuing regional standardised exercise~     programme.~   "
38574|NCT02552121|"~     The purpose of the trial is to establish the tolerability of tisotumab vedotin~     (HuMax-TF-ADC) in a mixed population of patients with specified solid tumors~   "
38600|NCT02551783|"~     This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa~     graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of~     repairing the strictured urethra. Current evidence suggests the two approaches for placement~     of the graft are equally successful at correcting the stricture and the two approaches have~     similar risks of complications. The investigators propose to randomly assign appropriately~     selected patients to either a dorsally- or ventrally-placed graft. No additional procedures~     beyond the normal care protocol will be required of the patients. Success will be assessed~     via objective and subjective methods; complications will be tallied in a standardized~     fashion. Outcomes will be measured at two years.~   "
38575|NCT02552108|"~     Generalized Anxiety Disorder (GAD) is a chronic condition that is characterized by excessive~     and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD~     at any point in time. These individuals have a lowered quality of life and are at risk for~     many medical conditions such as coronary heart disease and cancer. Research suggests that~     both pharmacological and psychological approaches are effective for treating GAD in the~     short-term; however, psychological treatments appear to offer the greatest long-term~     benefits. There exist a number of effective psychological treatments for GAD, most of which~     fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of~     Canadian investigators developed a CBT protocol for GAD that included four components. Data~     from five clinical trials suggest that one of the four components is particularly important~     for treatment success: experiencing uncertainty rather than avoiding it in everyday life.~     Stated differently, learning to tolerate and deal with uncertainty appears to be the key to~     decreasing worry and anxiety. Given this finding, the investigators have developed a new~     treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for~     Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the~     efficacy of BE-IU by comparing it to a Waiting List (WL) control condition. A total of 50~     participants with a primary diagnosis of GAD will be randomly assigned to either BE-IU or WL~     and will be assessed at 5 time points ranging from pre-treatment to 12-month follow-up. The~     conditions will be compared in terms of treatment efficacy and mechanisms. The investigators~     will also examine the predictors of change during the 12-months following treatment. The~     proposed study will produce data on the efficacy and mechanisms of a treatment for GAD that~     is less costly, less complex and easier to disseminate than treatments that are currently~     available.~   "
38576|NCT02552095|"~     The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee~     Replacement (PKR) with the Japanese population. It is expected that patients who receive the~     Triathlon PKR will achieve excellent clinical results without adverse effects and that the~     device fits well with Japanese morphology.~   "
38577|NCT02552082|"~     The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability~     (gap balance), and implant position (size and angle) for the Scorpio NRG device.~     Relationship between these parameters and clinical outcomes will be evaluated as well as the~     importance of rotational tolerance. It is expected that the Scorpio NRG will have good~     clinical outcomes and perform the same or better than other total knee implants.~   "
38578|NCT02552069|"~     The purpose of this study is to evaluate early fixation and stability of the Tritanium cup.~     It is expected that the Tritanium® cup will be equal to or better than conventional~     cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.~   "
38579|NCT02552056|"~     This randomized controlled trial will compare the effect of a CAMH integration package on~     yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among~     nurses, midwives and clinical officers who provide PHC services to children and adolescents~     in 42 health centers; and eligible traditional healers.~   "
38580|NCT02552043|"~     The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise~     program using the Wii video game platform as a training modality in Cystic Fibrosis (CF)~     patients. Investigators hypothesize that an exercise program performed by active videogames~     (AVG) will produce an improvement in exercise tolerance and muscular strength to be~     maintained over time in young CF patients.~   "
38581|NCT02552030|"~     In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S)~     to determine systolic blood pressure (RR) and compare it to conventional oscillometric~     measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and~     perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person.~     Primary parameter will be the absolute difference (Delta) between the correlating blood~     pressure measurements in mmHg.~   "
38582|NCT02552017|"~     The purpose of this study is to determine if a new device, called the Endocuff Vision (a~     small plastic device attached to the end of the colonoscope which helps by holding the folds~     of the bowel back to give a clear view of the inside of the bowel) will significantly~     improve the detection of adenomas when used in all patients referred for colonoscopy.~   "
38583|NCT02552004|"~     Intraoperative histological examination is a fundamental tool in surgery. Probe-based~     Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time,~     microscope-resolution imaging, currently used in endoscopy. This pilot study aims to~     evaluate pCLE in surgical setting. The objective is the depiction of histological rendering~     of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will~     also be assessed. All surgical conditions usually necessitating frozen section will be~     investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid,~     stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included.~     Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by~     retrospective analysis of the video sequences in comparison to conventional histology~     slides. The data will be used to create an image bank of reference optical biopsy images.~     The study will allow to point out the surgical conditions in which pCLE is the most~     effective and reliable and could eventually replace the frozen section technique.~   "
38584|NCT02551991|"~     This is an open-label, phase 2 comparative study to assess the safety, tolerability, and~     efficacy of nal-IRI in combination with other anticancer therapies, compared to~     nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have~     not received prior chemotherapy. This study will assess the following regimens:~        -  nal-IRI + 5-FU/LV + oxaliplatin~        -  nal-IRI + 5-FU/LV~        -  nab-paclitaxel + gemcitabine~      The study will be conducted in two parts:~        1. a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and~        2. a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV,~          versus nab-paclitaxel + gemcitabine.~   "
38601|NCT02551770|"~     The aim of this controlled study is to assess the clinical outcomes and patient reported~     outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an~     adjunct (test treatment) or without Straumann Emdogain (control treatment).~   "
38602|NCT02551757|"~     The purpose of this study is to assess the effect of continuous positive airway pressure~     (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a~     sham-controlled, double-blind pilot trial during inpatient rehabilitation.~      Patients with acute stroke were recruited and randomly assigned to auto-titrating or~     sham-CPAP during their rehabilitation stay.~   "
38603|NCT02551744|"~     Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in~     thienopyridine users remains unclear.~   "
38902|NCT02547844|"~     To compare the lipidomic profile in patients with HIV-1 with viral suppression changing~     efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir~     (Eviplera®) versus a group of patients that continue with Atripla®.~   "
38585|NCT02551978|"~     Obesity and its associated comorbidities are becoming a key and rapidly growing public~     health problem. The cause of obesity is an imbalance between energy intake and energy~     expenditure in favor of the former. Childhood and adolescence are seen as critical time for~     its development. It is therefore crucial to provide both prevention and treatment actions~     already during childhood. The prevention and treatment weight-management programs in~     children focus on improving diet, eating behaviours, psychosocial aspects and increasing~     physical activity. One important basic requirement for any weight-management program is,~     that both children and their families are motivated and ready for change. Video games,~     including exergames, serious games or combined approaches offer additional chances in the~     treatment and prevention of obesity by approaching children in their environment and~     motivating them to deal with life-style topics.~      The investigators developed a motion-controlled serious game for children aged between 9 and~     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial~     factors. In addition to the motion control, a tablet is used for knowledge-based and~     cognitive tasks. In comparison to other studies the nutrition part not only deals with the~     food pyramid but also with the energy density of foods and liquids and offers a~     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological~     aspects, especially stress and stress-coping strategies are addressed e.g. by~     relaxation-exercises. The game consists of two sessions, having each a duration of about 35~     minutes.~      The aim of this study is to evaluate the program in a cluster-randomized controlled trial in~     a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of~     the same school will be randomly allocated to an intervention and a control group. The~     intervention group will play the game within two weeks, whereas the control group will~     receive basic information. At baseline, two weeks after baseline and at four weeks~     follow-up, measurements will be performed. The primary outcome of the study is the gain of~     knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires~     tailored specifically for the serious game. Secondary outcomes are the acceptance of the~     game, changes of nutrition behaviour, physical activity and intentions of the children to~     follow a healthy lifestyle, measured by mostly validated questionnaires.~   "
38586|NCT02551965|"~     In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the~     clinical risk factor of exhaustion, the researchers propose to conduct a prospective~     observational study during 6 months phone follow up of the caregivers. The recruitment will~     take place during the oncogeriatric assessment consultation.~   "
38587|NCT02551952|"~     INTRODUCTION: Cognitive dysfunction is a frequent adverse event in the postoperative period,~     especially in elderly patients. The tests commonly used for the detection of postoperative~     cognitive dysfunction are time-consuming and with variable sensitivity and specificity and~     difficult routine use. Applying a difficult battery of cognitive tests decreases the~     viability of adopting measures to increase preoperative cognitive reserve and methods for~     prevention, diagnosis and rehabilitation of cases of Postoperative Cognitive Dysfunction~     (POCD), it is desirable to search for alternative methods diagnoses.~   "
38588|NCT02551939|"~     A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast~     augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and~     1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and~     well-being of patients during the preoperative and 1 year post operation.~   "
38589|NCT02551926|"~     Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular~     diseases. Health education via electronic pathways such as mobile text messaging or virtual~     communities may provide more availability and adherence than printed media. Regarding lower~     costs of such electronic resources and continuity of interventions through these ways,~     assessing their effectiveness compared to a printed material may help health educators to~     choose proper methods for improve their educational attempts. Therefore, the current study~     aims to compare different tools for health education about healthy lifestyle in people with~     prehypertension. For this, educational interventions with similar content among 3 groups of~     people will be conducted (i.e., first group via mobile text messaging, second group using~     virtual communities, and third group by brochures as a printed media). A control group also~     will be considered without any intervention. Several phases are considered in the study. In~     phase 1 using health centers located in Qazvin city, people would be invited to a free~     screening program of prehypertension. Then, an eligible sample will be divided in three~     groups using a random allocation process (each one including 100-150 people with~     prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II)~     will be measured before intervention. A standard educational content using approaches of~     lifestyle promotion defined in HPLP II would be available for intervention groups during a~     time period of 1 month concurrently. At final phase, one month after termination of~     intervention blood pressure as primary outcome and lifestyle changes along with~     self-efficacy for lifestyle modification as secondary outcomes will be measured. This study~     may suggest effective ways for health education which is applicable by health care~     professionals to promote health status among peopleat risk of hypertension.~   "
38590|NCT02551913|"~     Sleep education has been used as a method of primary and secondary prevention of sleep~     problems in all age groups. An especially vulnerable age group are adolescents who~     frequently have poor sleep habits and suffer from sleep deprivation. In adolescents,~     insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated~     with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher~     levels of risk-taking behavior, poor school performance, and increased risk of unintentional~     injuries. As an US study has shown, sleepiness was the major causal factor in many traffic~     accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger.~     The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene~     intervention in improving sleep quality in adolescents.~   "
38591|NCT02551900|"~     Warm water based cycling exercise training would more favorable than cold water based~     cycling exercise training and land based cycling exercise in vascular function in type 2~     diabetic patients.~   "
38592|NCT02551887|"~     Primary, Secondary, and Exploratory Objective(s):~      Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV~     vaccine.~   "
38593|NCT02551874|"~     This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)~     will compare the glycemic control (measured by HbA1c) in subjects co-administered~     saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to~     subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea,~     over a treatment period of 52 weeks.~   "
38594|NCT02551861|"~     The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or~     without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected~     patients without advanced fibrosis or liver cirrhosis who have never been treated~     previously.~   "
38595|NCT02551848|"~     The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected~     utilizing kinematically-based injection parameters for the treatment of upper extremity~     essential tremor (ET). Additional objectives are to study the benefit of kinematic~     assessment tools in determining injection parameters and to study the composition of tremor~     using kinematics.~   "
38596|NCT02551835|"~     This meta-analysis will be conducted to study the effect on vitamin D supplements on markers~     for cardiovascular disease and diabetes using individual participant data from 12 RCTs.~     Given that previous data suggest that vitamin D supplementation might be most effective in~     those individuals with very low 25-hydroxyvitamin D (25(OH)D) and potentially harmful in~     those achieving very high levels after vitamin D supplementation, this meta-analyses will be~     performed in subgroups according 25(OH)D levels.~   "
38604|NCT02551731|"~     Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of~     epilepsy that usually strikes children in the first year of life. There is a great need for~     safe and effective therapies in the treatment of IS. This need is even more important for~     infants and toddlers still sick after being treated with medicine that is already available.~      This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral~     Solution (COS) in the treatment of children aged 6 months through 36 months with a diagnosis~     of infantile spasms who have not responded to first line therapies.~      The overall study duration is expected to be 64 weeks for those subjects who respond to COS~     treatment. The maximum possible study duration for each patient is approximately 64 weeks,~     however a subject will be deemed to have completed the study after 58 weeks.~   "
38605|NCT02551718|"~     This pilot clinical trial studies the feasibility of choosing treatment based on a high~     throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients~     with acute leukemia that has returned after a period of improvement or does not respond to~     treatment. A high throughput screening assay tests many different drugs individually or in~     combination that kill leukemia cells in tiny chambers at the same time. High throughput drug~     sensitivity assay and mutation analysis may help guide the choice most effective for an~     individual's acute leukemia.~   "
38606|NCT02551705|"~     Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the~     western world it affects 5-10 persons per 100000. The main brain changes include the loss of~     brain cells in subcortical structures. The symptoms of HD include involuntary movements,~     cognitive deterioration and behavioural disturbances. It has been shown that changes in~     emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in~     perception of emotions has been primarily investigated by means of facial expressions.~     However, emotions can also be expressed through body language. Here, the investigators~     propose to investigate whether the emotion comprehension deficit in preHD also includes body~     language comprehension.~   "
38607|NCT02551692|"~     The goal of this study is to evaluate the effects of varenicline versus nicotine replacement~     versus placebo on personal smoking environment cue (PSE) reactivity. The results of this~     study will inform whether first-line pharmacotherapies for nicotine dependence (e.g.~     nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose~     to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1~     training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check~     sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC;~     n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind,~     double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will~     be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking)~     repeated measures ANOVAs with random-effects. The investigators hypothesize that personal~     smoking, as compared to nonsmoking environments, will be associated with greater reactivity~     (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x~     Environment interaction will be characterized by decreased reactivity to smoking as compared~     to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.~   "
38608|NCT02551679|"~     The primary objective of this study is to determine the efficacy and safety of intramuscular~     injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical~     limb ischemia who are receiving standard of care therapy and have no endovascular or~     surgical revascularization options.~   "
38609|NCT02551666|"~     The goal of this translational research study is to evaluate the efficacy and feasibility of~     balance recovery training as an on-site fall prevention exercise intervention for older~     adults living in retirement communities. Falls are the leading cause of injuries and~     injury-related deaths among older adults over the age of 65 in the United States. While it~     is generally accepted that exercise helps prevent falls, exercise does not always reduce the~     number of falls, and it remains unclear which types of exercise are most effective at~     preventing falls. Balance recovery training (BRT) is a novel exercise intervention that has~     that has the potential to decrease the number of falls among older adults by improving their~     balance recovery ability after common balance perturbations such as tripping. BRT involves~     repeatedly exposing individuals to postural perturbations in a safe, controlled setting that~     allows reactive balance recovery to be practiced and improved. The investigators will~     administer BRT on-site at continuing care retirement communities over four weeks to older~     adult fallers and determine its effects on balance recovery ability over the following six~     months compared to another group of older adult fallers performing Tai Chi as an alternative~     exercise intervention. To further address the potential for BRT to be translated into~     typical practice within retirement communities, the investigators will also collect data on~     facilitators and barriers to the long-term sustainability of BRT in retirement communities~     using qualitative methods. These quantitative (balance recovery ability) and qualitative~     (implementation process) measures will provide the basis for a subsequent large practical~     clinical trial to test the effectiveness of BRT on reducing the number of falls among older~     adults.~   "
38610|NCT02551653|"~     Pulmonary arterial hypertension (PAH) involves the narrowing of blood vessels connected to~     and within the lungs. Focal adhesion kinase (FAK) is a focal adhesion-associated protein~     kinase involved in cellular adhesion and spreading processes which leads to stiffening and~     thickening of blood vessels in lungs. This further increases the blood pressure within the~     lungs and impairs their blood flow. This study aims to demonstrate biodistribution of FAK~     inhibitor, GSK2256098, in cardiopulmonary sites i.e. heart and lung tissues. The uptake of~     11C-radiolabelled GSK2256098 within the lung and / or heart of healthy subjects and~     idiopathic pulmonary arterial hypertension (iPAH) patients will be assessed using Positron~     Emission Tomography (PET). Based on study results the decision as to whether a follow-on~     phase 2 trial should be initiated to investigate the therapeutic utility of GSK2256098 in~     iPAH will be decided. Sufficient number of subjects will be screened (up to 30 days prior to~     scan) to enrol 12 healthy subjects and 12 PAH patients in the study. Enrolled subjects will~     receive a microdose of [11C]-GSK2256098 on a scanning day which will be followed by the~     follow-up visit (2-4 weeks post-last dose).~   "
38621|NCT02551510|"~     Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure~     to port plant in terms of cosmetic results and time savings at comparable risk for wound~     infection.~   "
38611|NCT02551640|"~     The goal of this study is to explore the effects of FeatForward on physical activity and~     cardio-metabolic risk factors. The study will be implemented as a 2-arm randomized~     controlled trial (RCT) comparing the effects of FeatForward in patients assigned to use the~     application versus a control group who will not use the app over a 6-month follow-up period.~     The investigators hypothesize that subjects using FeatForward will be more physically active~     and will achieve greater improvements in their cardio-metabolic risk (CMR) factors than a~     usual care control group that will not use the app over a 6-month period.~   "
38612|NCT02551627|"~     This will be a double blind, two-arm, parallel-group, stratified for gender, randomised,~     controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the~     hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed~     through vaccine response in 7-10 yrs old school participants.~   "
38613|NCT02551614|"~     This is an exploratory study to further develop an imaging platform for the assessment of~     whole lung neutrophil retention. The primary objective of the study is to quantify and~     compare neutrophil retention in the lungs of lipopolysaccharide-challenged healthy subjects,~     saline-challenged healthy subjects and subjects with stable COPD. There will be two~     treatment groups, one with healthy subjects and the other with subjects with stable COPD.~     The total duration of this study for healthy subjects will be approximately 1 week, in~     addition to the screening window of 28 days. The total duration of this study for subjects~     with COPD will be approximately 1 week for those that complete Visit 1 only, and~     approximately 2 weeks for those subjects with COPD that return to the unit for Visit 2 7-10~     days later, in addition to the screening window of 28 days.~   "
38614|NCT02551601|"~     The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai~     eyes and study the associations with gender, age, refractive error and axial length using~     spectral-domain optical coherence tomography with enhanced depth imaging technique.~   "
38615|NCT02551588|"~     Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the~     obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography~     Doppler, which assesses two key markers that are aortic valve pressure gradient and the~     aortic valve area. however these marker are a poor reflect of the clinical severity of AVS.~     The aim of the study is to validate new markers assessing cardiac fibrosis that might best~     or complementary markers.~   "
38616|NCT02551575|"~     This is prospective randomized, controlled study to evaluate the efficacy and safety of~     Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis~     (RA). The major outcome index is the change from baseline to week 24 in Disease Activity~     Score (DAS28), and minor outcome indexes include American College of Rheumatology~     (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any~     time were recorded to evaluate the safety.~   "
38617|NCT02551562|"~     20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation~     treatment, meet all the inclusion and none of the exclusion criteria, and have signed a~     written informed consent, will be enrolled. Subjects will be divided randomly into two~     treatment groups:~        1. Group A: subjects will use a basic skin care regime following a full facial~          rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.~        2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation~          with hyaluronic acid soft-tissue filler and botulinum neurotoxin.~      The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit~     2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation~     (Visit 5).~      Changes in the subjects' quality of skin will be determined by the PI's assessment of skin~     tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as~     well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and~     hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.~      Subjects' satisfaction with treatments and their quality of skin will be determined through~     a self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The~     impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks~     following the treatments.~   "
38618|NCT02551549|"~     A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics~     of CD101 Injection in Healthy Subjects.~   "
38619|NCT02551536|"~     Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population~     worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene~     receptor antagonists, intranasal corticosteroids are the pillars in the management of~     AR.Materials and methods: Seventy patients with allergic rhinitis participated in a~     prospective, randomized, double-blind, parallel, active controlled, comparative 4 week~     trial. The patients between age group of 18-65 years of either gender having moderate-severe~     intermittent or mild persistent allergic rhinitis were included. The study inclusion~     criteria required the subjects with Total Nasal Symptom Score (TNSS) of 5 or higher. The~     patients were randomly divided into two treatment groups with montelukast-levocetrizine (10~     mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group.~     TNSS parameter was the main effectiveness parameter.~   "
38620|NCT02551523|"~     Long term toxicity of combination antiretroviral therapy (cART) is a substantial contributor~     to morbidity and mortality in chronically infected HIV positive individuals. To date it is~     still debated, whether long term nucleoside reverse transcriptase inhibitors (NRTI's)~     -sparing regimens are practicable or even superior compared to standard of care cART in~     terms of efficacy, safety and tolerability. In addition, data about efficacy of integrase~     inhibitor (INSTI) based monotherapy is lacking. We aim at investigating the efficacy of~     standard of care combination antiretroviral therapy with a simplified dolutegravir~     monotherapy in patients with a primary HIV-1 infection under suppressive early standard of~     care antiretroviral therapy. Briefly, hundred-thirty-eight patients with a documented~     primary HIV1- infection (PHI) will be recruited from the Zurich Primary HIV-1 Infection~     Study (ZHPI), which is an open label, non-randomized, observational, single-center study~     (http://clinicaltrials.gov, ID 5 NCT00537966). All subjects formerly underwent early cART~     consisting of either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase~     inhibitor (NNRTI) or a INSTI in combination with two NRTIs at the time point of enrolment in~     the ZPHI and must be under a fully suppressive ART (i.e., <50 copies/ml) for at least 48~     weeks at the time point of randomisation. The primary end point is the proportion of~     individuals with a viral failure at week 48 or before.~   "
38623|NCT02551484|"~     50 patients will be included for each of the 2 procedures:~      - For procedure 1: Patients will be selected during multidisciplinary consultations for~     amputees who are stabilized with their definitive prosthesis and have returned to their~     usual place of residence. The aim of this procedure is to show the validity and~     reproducibility of measurements of tissue oxygenation using NIRS (TcPO2 being the reference~     measurement), to determine the way in which NIRS measurements are more precise (i.e. in~     terms of validity and reproductibility) (values at rest with the patient lying perfectly~     flat or with the amputated limb raised 30°). These patients will require a single visit~     which will include measurements by NIRS and TCPO2, a walk test and the completion of 2~     questionnaires (visual scale).~      - For procedure 2: The patients will be included in the initial phase of postamputation~     rehabilitation, during the period of in-hospital rehabilitation. The main problems of~     healing and tolerance to the temporary prosthesis arise during this phase. The specific~     objectives will be: To show that measurement by NIRS predicts the quality of healing in~     trans-tibial amputees; to show that the zone of uncertainty concerning the predictive values~     for the viability of the stump is smaller with NIRS than with TcPO2 (better discrimination).~     NIRS and TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30~     and 45 days after the amputation.~   "
38624|NCT02551471|"~     The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15%~     are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection~     margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The~     invasion of the resection margins triples the risk of local recurrence. In the absence of~     surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of~     rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative~     resection. The care and management of locally advanced and fixed rectal tumours and pelvic~     recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a~     difficult therapeutic problem with great variability in the methods of care and management~     around the world. These variations in practice can be explained by structural and~     organizational differences, as well as cultural dissimilarities. With regards to the~     organization of its healthcare system, Australia is shown to be a leader as regards the care~     and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal~     cancer.~   "
38625|NCT02551458|"~     Step 1: Inclusion of eligible patients to carry out a translational search for prognostic~     and predictive markers of Complete Clinical Response and Pathologic Complete Response (using~     blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its~     toxicity.~      The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The~     RCT will thus be chosen by the investigator from published effective schemes in a~     pre-operative setting or in patients not undergoing surgery.~      Evaluation of the response 5 to 6 weeks after the RCT.~      Step 2: Randomisation in patients with a complete clinical response:~      Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable~     loco-regional recurrence~      Patients not eligible for randomisation will have the possibility to participate in a~     specific study (information can be obtained from the SAKK group (Switzerland Group Clinical~     Research on Cancer)).~   "
38626|NCT02551445|"~     This study involves people with eating disorders and healthy volunteers (people who have~     never experienced an eating disorder). Participants are interviewed about their~     psychological and physical health by the experimenter and they have a simulated scan session~     (about 1 hour). Approximately 1 week after they attend the first study session. They are~     asked to complete questionnaires and computerized tasks (about 30 minutes) followed by the~     active scan (1 hour). During the brain scan they look at pictures and answer questions about~     the pictures. After the first study session, people with eating disorders receive an~     intensive meal-support intervention (in the following 3 months) aimed at reducing anxiety~     and fears related to food (10 sessions lasting about 60 min.). Three months after the first~     brain scan, participants with eating disorders and healthy controls receive a second~     assessment and brain scan. We hypothesized that the meal support intervention will be~     effective in: 1) targeting eating disorder symptoms (body mass index - BMI, primarily) and~     2) producing functional changes in brain regions that underline food-related anxiety and~     avoidance.~   "
38627|NCT02551432|"~     Patients with refractory SCLC. Patients will be treated with paclitaxel and pembrolizumab.~   "
38628|NCT02551419|"~     A six month, placebo-controlled, parallel group project in which MCI participants will~     receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo.~     Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before~     and after the intervention will be assessed by PET (position emission tomography) imaging,~     as well as fMRI, diffusion MRI and cognition.~   "
38629|NCT02551406|"~     Different tools may be used to monitor the efficacy of home mechanical ventilation.~     Investigators aimed to compare the prognostic value of the different data obtained by~     capno-oxymetry in a mechanical ventilated neuromuscular disease's population.~   "
38630|NCT02551393|"~     Clinical Trial: The investigators aims at comparing providing validated home BP device,~     followed by group education of self-management of hypertension as well as self-BP monitoring~     and appropriate medication in response to home BP reading, followed by nurse follow up with~     usual care, which may possibly improve older adults with uncontrolled hypertensions drug~     adherence, and therefore improve their BP level in primary care setting. The investigators~     will invite total 270 patients from 6 general outpatient clinic (GOPCs) to participate the~     trial.~      Qualitative study: The investigators would also like to evaluate patients' view and~     operational concerns on self BP monitoring by individually interviewing 30 selected patients~     from intervention group~   "
38631|NCT02551380|"~     The investigator planned to study the efficiency of folinic acid treatment on autistic~     symptoms in children suffering from autism spectrum disorder.~   "
38653|NCT02551094|"~     The study evaluates whether long-term treatment with colchicine reduces rates of~     cardiovascular events in patients after myocardial infarction. Patients who have suffered a~     documented acute myocardial infarction within the last 30 days, are treated according to the~     national guidelines and after having completed any planned percutaneous revascularization~     procedures associated with their initial infarction will receive either colchicine (0.5 mg~     per day) or matching placebo (1:1 allocation ratio) for an estimated 2 years period or until~     the target of 301 primary endpoints has been reached.~   "
38632|NCT02551367|"~     110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35~     distributed randomly :~        -  55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday~          of the cycle for three successive cycles.~        -  55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to~          the 6thday of the cycle for three successive cycles.~      Patients will be subjected to:~      Complete history taking:~        1. Details about name, age~        2. Menstrual history with determination of menarche~        3. Amenorrhea or oligomenorrhea , Regularity of the cycle~        4. History of endocrine disease.~        5. History of previous operations.~             -  Physical examination:~             -  General examination:~           With special concern to:~           --Acne.~           --Hirsutism .~           --Weight.~           --Height~           --BMI was determined :~           Wt. in kg ـــــــــــــــــــ =~           ) Height in m)2~           - Abdominal examination :~             -  for scar of previous pelvic or abdominal operations .~                  -  Pelvic examination :~             -  vaginal examination for enlarged cystic ovaries.~                  -  ultrasound for diagnosis of pcos.~           PARAMETERS:~      (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3)~     number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical~     pregnancy. (7) ongoing pregnancy~   "
38633|NCT02551354|"~     Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric~     labor and childbirth. It consists in establishing a catheter into the epidural space and to~     block the transmission of pain sensations by injecting a local anesthetic and an opioid. In~     10-25% of cases the epidural does not give perfect results, causing it to test its~     effectiveness, which is mainly done by questioning the patient on mitigation or~     disappearance of pain. This collaboration of patients is sometimes limited in our care~     structure by the inability to assess or express the pain, mainly due to cultural differences~     or language barriers, which can represent up to 15% of women in our institution. This led to~     develop objective measures of pain techniques used at the bedside.~      Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of~     the pupil, and parasympathetic system (pΣ).~      The PD increases in response to painful stimulation, in proportion to the intensity of the~     nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of~     pain in patients under general anesthesia, but has been little studied in conscious~     subjects.~      There are other permanent changes in the PD, due to constant interaction between Σ and pΣ~     systems. Few data have been published to date on this PD variability (PDV).~   "
38634|NCT02551341|"~     Randomized study investigating the effects of lung protective ventilation (PEEP), as~     compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and~     water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients~     undergoing assisted robotic radical prostatectomy~   "
38635|NCT02551328|"~     The main aim of this study is to compare markers of cardiac injury (Troponin I),~     inflammatory response and platelets function during minimally invasive mitral valve repair~     or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo~     \propofol)~   "
38636|NCT02551315|"~     This multicenter, prospective, observational cohort study will assess bone differences in~     women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.~   "
38637|NCT02551302|"~     Effectiveness of hybrid systems (topping off) compared to rigid spondylodesis in fusion~     surgery of the lumbar spine: A prospective, randomized, bicentric pilot study (CD HORIZON~     BalanC™)~   "
38638|NCT02551289|"~     One in 100 people suffers from coeliac disease. It affects the lining of the bowel and~     causes many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The~     only treatment so far is a strict glutenfree diet for life which reverses the bowel damage~     and often improves symptoms. Up to 25% of patients however may have persistent symptoms~     despite the gluten free diet but the reasons for this are not clear.~      This research aims to help us understand how the gluten free diet works. Investigators will~     use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in~     the small bowel, the size of the large bowel and the time it takes for foods to go through~     the entire bowel in patients who have just been diagnosed with coeliac disease by their~     hospital doctor. Investigators will also carry out a breath test and collect a stool sample~     for basic analysis of the stool bacteria.~      Investigators will also collect questionnaires about their feelings and their bowel habits~     and will try to see how the MRI measurements relate to the patients' symptoms. Investigators~     will observe how all these measures change after one year of the gluten free diet that~     doctors will have prescribed as part of the coeliac patients' standard care. As such there~     is no dietary intervention in this study, investigators will simply study changes in the~     patients due to their standard treatment. Investigators will also look at a matched group of~     healthy volunteers to gather a likely reference range of the measurements. This research~     will be carried out in Nottingham with the help of the specialist coeliac clinics and it~     will last 3 years. There is a dedicated Coeliac Patient Public Involvement group who have~     helped plan this study.~   "
38639|NCT02551276|"~     Studies in animals have shown that beta2-adrenoceptor activation with selective agonists~     regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These~     effects may be mediated by cAMP/PKA dependent activation of several downstream sites that~     modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is~     well-described in animals, it is inadequately explored in humans. The purpose of the study~     is thus to investigate the effect of chronic beta2-adrenergic stimulation~     (cAMP/PKA-signaling) on muscle hypertrophy.~   "
38654|NCT02551081|"~     The purpose of study is to evaluate the benefits of using the Next Generation Sequencing~     Technology to diagnose birth defects and genetic diseases. The results from genomic~     sequencing can also significantly shorten the time of examination, improve the diagnosis~     rate, guide the clinical treatments. So the ultimate goal is individualized or personalized~     therapy and promote prognosis.~   "
38655|NCT02551068|"~     The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking~     nintedanib will have improved exercise endurance, breathlessness and quality of life if~     breathing 60% oxygen compared to standard of care during an 8 week exercise training~     program.~   "
38640|NCT02551263|"~     This is a observational study in a real-world setting, not requiring determining a dosage~     regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose~     of the study is to investigate the efficacy of eribulin as the first or second line~     chemotherapy to prolong overall survival and to explore factors affecting the survival in~     patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast~     cancer who scheduled to receive the first or second line chemotherapy in clinical practice~     in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year~     enrollment period and 3-year observational period; the duration of patient participation~     will be 3 years. All patients will receive adequate treatment for breast cancer which~     selected by the primary physician after enrollment using the Japanese Breast Cancer Society~     Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network~     (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites~     will enter patient data into an electronic data capture (EDC) system up to the third~     chemotherapy in the study. The end of the study is defined as the time the last patient~     completes observational period. Patients will primarily be assessed by overall survival (OS)~     of the first line chemotherapy.~   "
38641|NCT02551250|"~     The investigators will investigate the usefulness of biannual ultrasonography versus annual~     non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in~     single arm patients.~   "
38642|NCT02551237|"~     The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine)~     to a short course RT associated with a delayed surgery, with two primary objectives: the~     efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).~   "
38643|NCT02551224|"~     The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of~     the Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference~     questionnaire.~   "
38644|NCT02551211|"~     With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small~     cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for~     lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and~     non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on~     the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would~     allow physicians to monitor the immune status of their patient's tumor and though to~     evaluate the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such~     blood marker has been validated so far. The LYMPHOLUNG study investigate the concordance~     between blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC.~     By the use of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The~     prognostic value of the circulating and intra-tumoral T regulator over total lymphocytes~     ratio for 2-year recurrence-free survival will also be addressed.~   "
38645|NCT02551198|"~     Colonoscopy is considered by many the preferred mode of screening for colorectal cancer~     (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate~     bowel preparation.~      For bowel preparation, effective, well-tolerated and safe methods should be applied.~      Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of~     direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate~     solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned~     the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel~     preparation~   "
38646|NCT02551185|"~     This is a Phase 1b, multicenter, single arm, open label, dose escalation study to determine~     the MTD and evaluate the safety and preliminary antitumor activity of orally (PO)~     administered ACY 241 in combination with intravenously (IV) administered paclitaxel in~     eligible patients with advanced solid tumors.~   "
38647|NCT02551172|"~     To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic~     patients with high risk for CHD.~   "
38648|NCT02551159|"~     This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine~     the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy~     versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received~     prior systemic chemotherapy for recurrent or metastatic disease.~   "
38649|NCT02551146|"~     The aim of this study is to assess the influence of this particular treatment method on the~     patients' quality of life and masticatory function.~   "
38650|NCT02551133|"~     This study evaluates the effect of dexamethasone on persistent surgical pain after~     mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the~     other half will receive 0.2 mg/kg dexamethasone.~   "
38651|NCT02551120|"~     Hypoparathyroidism (hypoPT) and pseudohypoparathyroidism (Ps-hypoPT) are rare diseases,~     characterized by low levels of parathyroid hormone [PTH] and plasma calcium or high plasma~     PTH and low plasma calcium, respectively. A recently study by the investigators' group,~     identified 123 living persons with idiopathic hypoPT and 62 living persons with Ps-hypoPT,~     only few of these have been genetic tested.~      The aim of the study is to perform a detailed clinical and genetic characterization of~     Danish patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by~     questionnaires, biochemistry, scans, bone biopsies and genetic tests. Furthermore the~     investigators aim to perform family tracing for the hereditary forms. The prevalence of~     magnesium depletion will be assessed as well.~      In addition to providing new information on symptoms, co-morbidity, and prognosis for this~     group of patients, the investigators presume that the study may improve their understanding~     on calcium homeostasis and bone metabolism in general.~   "
38652|NCT02551107|"~     This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants~     (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age~     matched controls without CHD. CHD patients will be divided into subgroups, based on their~     cardiac anatomy, to try and identify a level of risk of ciliary dyskinesia within the~     subgroup of CHD. Each of these sub groups' nNO levels will be compared between groups and~     against age matched control infants without CHD.~   "
38656|NCT02551055|"~     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended~     Part 2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel,~     paclitaxel, investigational TAK-659 or investigational alisertib in adult participants with~     advanced and metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a~     dose escalation phase (Part 1) and a dose expansion phase (Part 2).~   "
38657|NCT02551042|"~     Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels,~     mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon~     (fingers or toes turning white then blue in the cold) and digital ulcers (open sores on the~     fingertips). The purpose of this study is to see how effective the study drug Human Factor~     XIII Concentrate is in treating patients who have these and other common manifestation of~     Scleroderma. It will be given in addition to the accepted treatments used for this disease.~   "
38658|NCT02551029|"~     Brain imaging has shown abnormal brain activations in response to visceral stimulation in~     patients with the Irritable Bowel Syndrome (IBS). To investigate the possible role of the~     Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal~     afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior~     to this, an exploratory study in healthy volunteers will be conducted. This will be the~     first high magnetic field fMRI study evaluating the possible role of NTS activation in~     visceral abdominal pain. Moreover, this will be the first fMRI study using duodenal~     capsaicin infusion as a chemical stimulus, which is more physiological than~     mechano-stimulation.~   "
38659|NCT02551016|"~     The main objectives of this study are i) to assess how heart failure was captured accross~     different linked electronic health record sources within the CALIBER program and the overlap~     between primary care, hospital admissions and/or the national mortality register, and ii) to~     assess risk factors, heart failure treatment and survival in patients, stratified by EHR~     source.~   "
38660|NCT02551003|"~     This study examines the effect of cord blood in the treatment of newborn infants with~     neonatal encephalopathy in combination with hypothermia, which is the standard treatment for~     this condition. The hypothesis is that the cord blood + hypothermia combination will produce~     better neuroprotection than the standard treatment of hypothermia alone.~   "
38661|NCT02550990|"~     The purpose of this study is to determine the treatment effects of sequential combination of~     aerobic exercise and cognitive training on cognitive function, physiological markers, daily~     function, physical function, social participation and quality of life in stroke patients~     with cognitive decline. The investigators hypothesized that: (1) sequential training~     protocol can improve outcome measures compared to single mode of training; (2) these~     treatment effects will retain at 6-month follow-up.~   "
38662|NCT02550977|"~     The purpose of this study is to look into the effectiveness of a new investigational~     medication applied as a transdermal patch. The patch is applied on the skin with study~     medication that is absorbed through the skin suppressing ovarian activity and therefore~     preventing an egg from leaving an ovary (ovulation). The study will look into the study~     drug`s safety and how well it is tolerated and its absorption, breakdown and elimination in~     the body. It describes how the body affects a specific drug after administration.~   "
38663|NCT02550964|"~     The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy~     who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as~     rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the~     investigators will screen these patients by baseline examination (Fundus photography, fundus~     autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test~     and multifocal electroretinography) and observe with same examination for every year.~   "
38664|NCT02550951|"~     Its usefulness in implementing magnetic resonance angiography for postoperative follow-up of~     lymph lymphedema should try to evaluate and compare lymphoscintigraphy.~   "
38665|NCT02550938|"~     To demonstrate that a primer aligner product can achieve similar results to the currently~     marketed product.~   "
38666|NCT02550925|"~     This randomized clinical trial compares group acceptance and commitment therapy (ACT) to~     usual care for cancer survivors experiencing anxiety following the end of cancer treatment.~   "
38667|NCT02550912|"~     The purpose of this study to determine whether high dose vitamin D has positive effect on~     behavior of autistic children.~   "
38668|NCT02550899|"~     A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide~     hydrogel injection therapy for anal incontinence.~   "
38669|NCT02550886|"~     In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2~     billion. 47.9 percent involved hospitalizations during which surgical procedures were~     performed. Orthopedic procedures constituted the most frequently performed and most costly~     of operating room procedures. As the healthcare climate in the United States continues to~     change, there is a trend towards providing effective care in a fiscally conservative manner.~     Central to this strategy is the shift towards increasing ambulatory surgical procedures from~     surgeries requiring post-operative admission for patients. While savings to hospitals and~     third-party payers are implied, there may be an unrecognized increase in financial,~     physical, and psychosocial post-operative costs to patients undergoing ambulatory surgery~     and to their caregivers. Rawal et al., and McGarth and colleagues have found that patients~     undergoing orthopedic procedures had moderate to severe post-operative pain. We propose to~     present a survey to patients and their caregivers before surgery and at multiple timepoints~     post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In~     addition to assessing post-operative pain, this study serves to examine various other~     possible burdens to patients that have not been previously evaluated in this patient~     population.~      REFERENCES~      McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a~     moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J~     Anesth. 2004; 51:886-891.~      Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia~     following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.~   "
38670|NCT02550873|"~     This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed~     to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with~     IPF.~   "
38794|NCT02549261|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope~     located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).~     Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the~     efficacy and safety of the combination of Nimotuzumab administered concomitantly with~     chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in~     Combination With Radiochemotherapy treatment before the randomization,double~     blind,muti-center sites trial of this treatment.~   "
38671|NCT02550860|"~     The epidermal barrier efficacy is determined by the physicochemical properties of the~     epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role.~     Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving~     lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier~     through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many~     applications in clinical nutrition, mainly limiting water loss in patients receiving~     long-term LCPN and help in electrolyte and water balance.~      The objective of this interventional clinical trial is to evaluate the epidermal barrier~     function in patients receiving long-term LCPN comparing two compositions of IVFE: (i)~     soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem).~     Epidermal barrier function will be assessed through the transepidermal water loss (TEWL)~     measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The~     two IVFE (SO-based or FO-containing) will be compared using a randomized double blind~     crossover design, using patients as their own control. Each IVFE will be allocated for a~     3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's~     epidermal and red blood cell EFA profile will be determinate in order to facilitate result~     interpretation.~   "
38672|NCT02550847|"~     The aim of this study was to evaluate MR/PET with both functional and molecular imaging on~     the prediction of prognosis in patients with suspected pancreatic cancer.~   "
38673|NCT02550834|"~     This study investigates if, patients with diagnosed chronic spinal cord injury will benefit~     from an Indoor Curling Exercise program on their control capabilities of trunk movements and~     on their intrinsic motivation for physical activity. Half of participants will receive 8~     training-sessions during 4 weeks, while the other will receive usual care.~   "
38674|NCT02550821|"~     The purpose of this study is to compare physical activity levels between patients with~     bronchiectasis and healthy subjects.~      We hypothesize that patients with bronchiectasis will have lower levels of physical~     activity, since physical activity levels is affected by reduced exercise tolerance, severity~     of disease and other disease related symptoms and conditions.~   "
38675|NCT02550808|"~     This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic~     cardiopulmonary disease. The investigators will also investigate metabolic disorders like~     glucose metabolism, presence of metabolic syndrome, body composition and histological~     changes in skeletal muscle and body fat. Finally, patients will be followed for clinical~     endpoints.~   "
38676|NCT02550795|"~     Previous reports demonstrated that dexmedetomidine could reduce the incidence of~     postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for~     ajuvant drugs for preventing and reducing PONV. So investigator want to study about the~     effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.~   "
38677|NCT02550782|"~     Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery.~     Adjuvant agents are used in peripheral nerve blocks to increase the duration and block~     quality. We investigated that the effects of patient-controlled perineural dexmedetomidine~     application on postoperative analgesia.~   "
38678|NCT02550769|"~     INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a~     less invasive procedure that responds to some of the limitations of the rectal laparoscopic~     approach.~      MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion~     rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with~     the same pathological, functional and oncologic results.~      METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal~     cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general~     morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The~     sample calculation is 58 patients per group.~   "
38679|NCT02550756|"~     The purpose of this study is to confirm that the local anesthetic applied to subjects with~     Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure~     discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b~     study.~   "
38680|NCT02550743|"~     The primary goal of this Brown University Oncology Research Group is to determine that a~     safe dose of BYL719 can be administered with capecitabine and radiation in patients with~     rectal cancer. Therefore, the threshold of success for this phase I study is to establish~     safety.~   "
38681|NCT02550730|"~     Peer support during labor, birth and the perinatal period (also known as doula support)~     has been shown in some studies to reduce cesarean rates, postpartum depression and increase~     breastfeeding rates. The purpose of this program evaluation is to prospectively assess the~     clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the~     few established, hospital-based programs in the United States. To enhance the capability of~     the Birth Sisters Program to impact social determinants of perinatal health in a low-income~     population, the program evaluation will include the addition of Medical Legal Partnership~     for Children's (MLP) training and referral services. This program will be described as the~     Birth Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB~     compared with no Birth Sister support for women receiving maternity care at Boston Medical~     Center. Eligible women will be randomly assigned either BBB services or usual care. All~     women will be consented and interviewed in the mid-second trimester of pregnancy and~     interviewed again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8~     prenatal Birth Sister visits in the home or at Boston Medical Center starting at 6 months of~     pregnancy, continuous support through labor and birth, and up to 4 postpartum Birth Sister~     visits in the home or at Boston Medical Center. The usual care group will receive no birth~     sister support but does have access to standard interdisciplinary maternity care services.~     The primary outcomes will be reduction in cesarean rate. Secondary outcomes will include~     cost, labor interventions, infant outcomes, satisfaction with care and psychosocial~     outcomes, including depression, social functioning and self-efficacy.~   "
38682|NCT02550717|"~     To investigate the risk of major bleeding (including gastrointestinal and intracranial~     bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical~     practice~   "
38683|NCT02550704|"~     Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are~     three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion~     between these abnormalities is not known. We hypothesis there is a link between them in IBS~     with diarrhoea.~   "
38684|NCT02550691|"~     Spinal Muscular Atrophy (SMA) is a neuromuscular disorder characterized by loss of motor~     neurons in the anterior horn of the spinal cord and leading to muscle atrophy. SMA has an~     autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1~     in 40. In most cases, it is caused by homozygous gene deletion or gene conversion of the~     SMN1 gene (0+0 genotype) on 5q11-q13. This genomic region has been duplicated and inverted~     during evolution. Thus the SMN1 gene has a very homologous copy, called SMN2. Genetic~     counseling aim at detecting carriers with only one copy of the SMN1 gene (0+1 genotype). SMA~     carrier testing relies on total copy number quantification of the SMN1 copies by~     quantitative PCR methods. Nevertheless, cis-duplication of the SMN1 gene on one allele and~     deletion on the second allele (2+0 genotype) can lead to a misinterpretation as molecular~     methods show 2 copies of the SMN1 gene and cannot detect the carrier status.~      The aim of the study is the characterization of a biomarker specific of the cis-duplication~     of the SMN1 gene in order to allow the detection of this 2+0 genotype which constitutes a~     trap for genetic counseling. We will use molecular combing to identify a genomic morse code~     (GMC) composed of a combination of probes specific of a structural motif on the~     cis-duplication chromosome. The characterization of this GMC is based on the comparison of~     two sample groups:~        -  The test group, with a maximum of 137 individuals carrying 3 copies of the SMN1 gene~          (suggesting a cis-duplication on one allele)~        -  The control-1 group, with a maximum of 137 individuals carrying 2 copies of the SMN1~          gene~      A pilot study performed on 24 samples in the two groups is needed to define the exact sample~     number necessary for statistical analysis of the study. When the GMC will be characterized,~     its specificity will be evaluated by testing two sample groups:~        -  The test group, with 37 individuals carrying 3 copies of the SMN1 gene~        -  The control-2 group, with 37 individuals carrying 3 copies of the SMN2 gene Molecular~          combing needs long DNA fibers and usual methods for DNA extraction are not appropriate.~          This project requires new blood samples for specific DNA extraction.~      If this project is successful, during a second project, this GMC will be converted into a~     simple and cheap PCR-based method. We will then evaluate the sensitivity of this method on~     our sample collection, notably on individuals with the 2+0 genotype defined by familial~     genotyping.~   "
38685|NCT02550678|"~     The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal~     cell carcinoma (nBCC) in patients aged 18 years or over.~      The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU~     for 3 weeks and undergo surgical excision of the tumor.~   "
38686|NCT02550665|"~     This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg~     for patients with Alzheimer's disease. Investigators randomly divide participants into three~     groups according to the dose escalation method; no titration, 15mg of donepezil for a month~     before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to~     23mg.~   "
38687|NCT02550652|"~     This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate~     (MMF) with placebo plus MMF in Class III and IV patients with proliferative Lupus Nephritis~     (LN).~   "
38688|NCT02550639|"~     The aim of this prospective, randomized study is to assess a subject's immunological status~     against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT~     technique confirming previous results and establishing their statistical validity in order~     to determine whether this test could be used routinely in clinical practice to assess the~     risk of developing hCMV infection after renal transplantation and, ultimately, identify the~     most effective individual antiviral therapeutic strategy against hCMV.~   "
38689|NCT02550626|"~     Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be~     predictive factor for post-operative delirium. During 72hrs after spine surgery,~     investigator will observe occurrence of post-operative delirium, and analysis difference of~     a-synucleinopathy related non motor symptoms between 2 groups.~   "
38690|NCT02550613|"~     The purpose of this study is to explore the ability of integrated MRI/PET to detect and~     evaluate treatment outcome in HCC patients.~   "
38691|NCT02550600|"~     The purpose of this study is to compare the effect of interventional Lung Assist iLA activve~     to standard therapy in mechanically ventilated patients with severe acute lung impairment.~     Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or~     death) within 28 days compared to standard treatment.~   "
38692|NCT02550587|"~     The level of patient satisfaction is an important indicator of health care quality because~     it causes to reconsider the functioning of the hospital and go to the new regulations.~     Postoperative thought gives us important information for improving the quality of anesthesia~     care and health care quality. The investigators aimed to investigate the status of the~     anesthesia satisfaction in patients.~   "
38693|NCT02550574|"~     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during~     repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis~     compared to wound closure with sutures.~   "
38694|NCT02550561|"~     In 2014, the American Urological Association updated it management algorithm for~     Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses,~     interventions become increasingly invasive and morbid. 4th line treatment is sacral~     neuromodulation (SNM), involving a two stage surgical procedure and permanent device~     implantation. While the mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought~     act through central and peripheral mechanisms related to afferent signaling, causing~     modification of pain and lower urinary tract sensation.¹~      Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral~     neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks.~     The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS.~     The results of this study will suggest future directions and provide critical information to~     design studies to determine to what extent and in what situations PTNS may be effective.~      The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to~     treatment with 12 weekly treatments of PTNS. The investigators will assess symptoms and~     lower urinary tract function before, during and after the treatments. At the completion of~     treatments, subjects will be asked to enroll in post-study follow up monitoring to~     understand the duration of symptom effect.~   "
38695|NCT02550548|"~     This project is designed to advance understanding of the incretin effect in health and~     disease. This system of gut-islet linkage is essential for normal glucose tolerance,~     impaired in T2DM, and amenable to therapeutic intervention. However, there are important~     gaps in understanding incretin function that limit application of this system; this project~     will address several of these. A secondary, but critical aspect of this research is focus on~     inter-individual variation in the physiology of the incretin system. This is a novel~     direction for research in this field and is critical to advancing the concept of~     individualized medical care in diabetes by establishing whether there is a physiologic basis~     for predicting the existence of responders and non-responders to incretin therapies.~      Currently, we have described only Aim 1 from this grant in this protocol registration. While~     Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from~     this Aim and / or the publication of other results in the field may affect the approach to~     Aims 2 and 3.~   "
38696|NCT02550535|"~     This is a Phase I/II trial to determine safety, clinical efficacy and feasibility of a~     gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) and acute~     myeloid leukaemia (AML).~      Patient's white blood cells (T cells) will be modified by transferring a gene which enables~     them to make a new T cell receptor (TCR) that can recognize fragments of a protein called~     WT1 (Wilms' tumour 1) which is present at abnormally high levels on the surface of~     myelodysplastic and leukaemic cells.~      In this trial, approximately 25 participants with an Human Leukocyte Antigen A2 (HLA-A*0201)~     tissue type who have failed to achieve or maintain an IWG defined response following~     hypomethylating agent therapy will be recruited.~   "
38697|NCT02550522|"~     The BCI project falls within the very broad field of brain machine interfaces. Its multiple~     applications include the compensation of motor deficits. The subject of the present protocol~     is the first test of the system in man on the compensation of motor deficits by an epidural~     brain implant enabling an electrocorticogram (EcoG) to be recorded.~   "
38698|NCT02550509|"~     Muscle alterations and modifications passive biomechanical properties that occur on a~     spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin~     (TB) A is the reference treatment of the focused spasticity, and muscle source structural~     and biomechanical changes, very little studied in humans, especially since it is not one~     possibility of easily and reliably paraclinical assessment injections consequences.~   "
38699|NCT02550496|"~     Waiting for a proof by mycological culture is usually necessary before starting a systemic~     antifungal therapy. It therefore seems to us interesting to evaluate the benefit of using~     dermoscopy in clinical diagnosis of Tinea Capitis.~   "
38700|NCT02550483|"~     The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants~     will start with a 2-week free-living wash-in period where they will be asked to avoid~     certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In~     addition to the controlled diet, participants will consume one of three beverages (300~     mL/day; n = 12/group): placebo beverage (control), high beta-carotene tomato juice, and~     high-lycopene tomato juice. Blood, urine and feces will be collected throughout the study.~   "
38701|NCT02550470|"~     This is a prospective, randomized, double blind study investigating the duration of use and~     cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+,~     Drägersorb® Free.~   "
38702|NCT02550457|"~     This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back~     pain. All the subjects will be submitted to an evaluation of the painful sensation,~     functional performance, trunk range of motion and neuromuscular performance at three~     different times.~   "
38703|NCT02550444|"~     The purpose of this study is to evaluate effects of intravenous clonidine in acute and~     chronic post-cesarean pain, possible adverse effects over mother-newborn pair, in comparison~     to intrathecal adjuvant clonidine and placebo.~   "
38704|NCT02550431|"~     This study plans to learn more about puberty blockers and cross (testosterone and~     estradiol). There is not much known about how these medications affect hormone levels, heart~     health and overall general health in young transgender individuals.~   "
38705|NCT02550418|"~     The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily~     9 mg budesonide in patients with active ulcerative colitis~   "
38706|NCT02550405|"~     This project aims to (1) investigate behavioral and neural factors (e.g., emotional factors~     such as craving and cognitive factors such as decision-making)) associated with Internet~     addiction (mainly Internet gaming disorder ;IGD); (2) develop an tailored intervention~     (named craving behavioral intervention; CBI) for IGD based previous evidence; (3) evaluate~     the behavioral and neural effects of CBI on individuals with IGD. This project in~     implemented in Beijing, China, based on a relatively large sample of young adults with IGD.~     It will advance the investigators' understanding of the characters associated with IGD and~     the mechanisms underlying the psychological-based interventions in the field of IGD, as well~     as other addictive disorder. Moreover, this study will also shed new light on the~     development of more effective interventions.~   "
38707|NCT02550392|"~     Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting~     symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to~     describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account~     for more than half of all cases of stroke and they are at a higher risk to suffer a major~     stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying~     and reducing risk factors for a later stroke. However, people after a TIA often have limited~     access for further specialist support from stroke-specific rehabilitation services. Although~     there is variability in the level of recovery and severity of symptoms after TIA and minor~     stroke, there is evidence that these patients may experience difficulties that affect their~     quality of life including anxiety and depression.~      This study aims to develop, tailor and target the delivery of a time-limited group~     intervention that offers educational, psychological and social support for people following~     TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and~     experts working with people with TIA/minor stroke to develop the psychoeducational~     intervention. Following this, we will conduct a feasibility randomised controlled trial in~     one centre (Phase 2) to explore whether this group psychoeducational intervention for people~     after TIA and minor stroke carers is acceptable and to determine the feasibility of the~     proposed evaluation and the sample size needed in a definite trial.~   "
38747|NCT02549872|"~     Most patients with dementia in the UK use their local hospitals and general (family)~     practices throughout their illness. Linked electronic health records from primary care,~     hospital and death certificates records therefore provide useful information about the~     diagnosis and prognosis of patients who develop dementia.~      In this study we will assess the validity of dementia diagnoses in linked primary care,~     hospital and death records, by examining the timing of important health transitions in~     patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia~     in different age and sex groups~   "
38807|NCT02549092|"~     The primary objective of this study is to examine the effect of Levodopa-Carbidopa~     Intestinal Gel (LCIG) relative to that of OMT on non-motor symptoms associated with~     Parkinson's disease (PD).~   "
38708|NCT02550379|"~     While it has been hypothesised that individuals who experience social anxiety are more~     likely to misread facial emotions as threatening or disapproving, researchers have proposed~     that the difficulty may lie in decoding ambiguous facial expressions rather than identifying~     emotions which are expressed with greater intensity. Emotion recognition (ER) training~     provides a promising new avenue of research which may be beneficial in altering emotion~     processing biases which maintain or increase symptoms of mental health disorders. This study~     will examine the effectiveness of ER training in a community-based sample of young people~     (15-18 years) who report high levels of social anxiety. The intervention aims to alter~     emotion processing biases through a training procedure designed to promote the perception of~     happiness over disgust in ambiguous facial expressions which we hypothesise will~     subsequently reduce symptoms of social anxiety.~      The study design consists of two phases. During Phase 1 participants will complete a~     screening questionnaire. This questionnaire will include a measure of the affective,~     cognitive, and behavioural components of social anxiety in adolescence. Depending on their~     suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in~     Phase 1 of the study), participants may then be invited to take part in a 4-day~     computer-based emotion recognition training programme (Phase 2). The purpose of this phase~     is to see if ER training will help young people feel less worried or nervous in social~     situations by training them to interpret ambiguous facial expressions as expressing a~     positive emotion (happy rather than disgusted).~      Participants will be randomly assigned to either the intervention or placebo (inactive)~     group. Both groups will be asked to complete a 4-day programme involving one computer~     training session per day (each session takes approximately 20 minutes). Questionnaires will~     also be given to participants to complete before and after the intervention, along with a~     2-week follow-up assessment. These will include questionnaires to measure social anxiety,~     depressive symptoms, and fear of negative evaluation. Each questionnaire will take~     approximately 15 minutes to complete. Participants will not know whether they have received~     the intervention or placebo training until after the intervention.~   "
38709|NCT02550366|"~     Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac~     MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be~     used in the diagnosis of CAD. In this work, the investigators will develop and validate~     techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart,~     improved contrast, and superior spatial and temporal resolutions.~   "
38710|NCT02550353|"~     The aim is to evaluate the short-term changes in ocular surface measures and tear~     inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted~     laser in situ keratomileusis (FS-LASIK) procedures.~   "
38711|NCT02550340|"~     The study aims to determine if acute recreational alcohol intake is associated with the~     occurence of ECG changes and arrhythmias.~   "
38712|NCT02550327|"~     The objective of this study is to improve survival by the addition of anakinra to the~     chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with~     resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint~     of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin,~     and anakinra will improve disease-free survival (DFS) and to determine the number of~     patients who meet or surpass 11.5 months of DFS.~      The secondary objectives of this study are to evaluate the effect of anakinra when combined~     with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate~     and overall survival after diagnosis and adverse events of patients with resectable or~     potentially resectable PDAC. The investigators will use the benchmark of 24 months overall~     survival (OS) to determine how many patients meet or exceed this goal. The investigators~     will monitor, by survey, patients' health related quality of life while on treatment to~     determine if the addition of anakinra improves this measure.~   "
38713|NCT02550314|"~     To assess the efficacy and safety of the regeneration treatment of tympanic membrane with~     NPC-18 and FBG-18.~   "
38714|NCT02550301|"~     Platelets play a major role in thrombus formation and platelet size, measured by Mean~     Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with~     Myocardial Infarction (MI) and is an independent predictor of adverse events in patients~     with ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina~     is limited.~      Aspirin and clopidogrel are antiplatelet agents administered routinely to patients~     undergoing PCI and are required for stent patency. MPV is not known to be affected by low~     dose Aspirin. Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude~     of this reduction in MPV is unclear, especially in patients with stable angina undergoing~     PCI. An inverse correlation also exists between MPV and platelet count .~      The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel~     administration in patients with stable angina undergoing PCI.~   "
38715|NCT02550288|"~     This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10~     mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg~     alone when administered to Japanese participants with hypercholesterolemia. The primary~     hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior~     to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is~     superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein~     cholesterol (LDL-C) after 12 weeks of treatment.~   "
38716|NCT02550275|"~     Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by~     movement disorders, cognitive and behavioral. The social behavior of patients are changed,~     affecting interpersonal relationships. Patients with Huntington's disease are described as~     self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral~     problems can be a major source of anxiety for patients and their families. These disorders~     also have a negative impact cognitive and motor symptoms as well as the functional abilities~     and the quality of life of patients and their entourage. Authors have suggested that these~     problems could be related inter alia to social cognition disorders. This concept refers to a~     set of skills and emotional and social experiences that regulate relations between~     individuals and can explain the behavior of individuals and groups. The objective is to~     evaluate disorders of social cognition, which may account for behavioral changes in~     Huntington's disease.~   "
38758|NCT02549729|"~     The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT)~     on muscle function of postmenopausal women using or not using hormonal therapy replacement~     (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its~     severity and impact on quality of life and sexual function.~   "
38759|NCT02549716|"~     This study compares the bioavailability of IV and PO acetaminophen in both blood and the~     cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also~     compare the temperature and levels of inflammatory cytokines in both blood and CSF of~     patients treated with IV and PO acetaminophen.~   "
38913|NCT02547701|"~     Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or~     affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated~     topically with P-3058 nail solution according to the appropriate treatment schedule.~   "
38717|NCT02550262|"~     Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered~     with a pump that could only provide continuous infusion of the freezing medication in~     combination of pushes of medication activated by the patient, a technique called patient~     controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested~     that this continuous infusion of medication is not as effective as previously thought, and~     suggested that instead of continuous infusion, intermittent programmed pushes should be~     used. The investigators now have devices that are able to do that. Programmed intermittent~     epidural bolus (PIEB) is a new technological advance based on the concept that boluses of~     freezing medication in the epidural space are superior to continuous epidural infusion~     (CEI). The new pumps are able to deliver bolus of medication at regular intervals (PIEB), in~     addition to what the patient can deliver herself (PCEA). Studies have shown that delivering~     analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower~     the incidence of breakthrough pain, improve maternal satisfaction and decrease local~     anesthetic consumption. Based on the information already available in the literature, this~     study aims to determine the best regimen of PIEB achievable with our standard epidural~     mixture.~      The hypothesis of this study is that there is an optimal interval time between PIEB boluses~     of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will~     provide women the necessary drug requirements, thus avoiding breakthrough pain and need for~     PCEA or physician intervention.~   "
38718|NCT02550249|"~     Neoadjuvant nivolumab will be administered to patients with primary and recurrent~     glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.~   "
38719|NCT02550236|"~     The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective~     longitudinal population-based study with a life course approach to health and disease.~      The LIFE Child Study focuses on two main research objectives:~        -  monitoring of normal growth, development and health~        -  non-communicable diseases such as childhood obesity and its co-morbidities, atopy and~          mental health problems~      Detailed assessments will be conducted alongside long-term storage of biological samples in~     2,000 pregnant women and more than 10,000 children and their families.~   "
38720|NCT02550223|"~     Comparing an novel technique ( oblique view) during ultrasound guided radial artery~     catheterization versus Transverse and longitudinal views~   "
38721|NCT02550210|"~     In this study, the investigators will enroll women with palpable cancers to assess the~     accuracy of the Breast Cancer Locator (BCL) and concomitant procedure as a vehicle to~     optimize and validate the approach in surgical cases where the new device will not~     substantially alter or modify the standard-of-care procedure before initiating an evaluative~     trial of the BCL in non palpable breast cancer cases.~   "
38722|NCT02550197|"~     The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza~     vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern~     Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the~     Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.~      Objectives:~        -  To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016~          seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH~          2015-2016 formulation, with the requirements of the Committee for Medicinal Products~          for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.~        -  To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016~          seasonal formulations~   "
38723|NCT02550184|"~     Aim To investigate if the proportion of correctly diagnosed patients at 4 hours after~     arrival to the Emergency Department (ED) increases when patients are diagnosed with standard~     diagnostics and focused ultrasonography examination (f-US) compared to standard diagnostics~     alone.~      Methods The investigators are medical doctors who work in the ED and who use f-US as a~     diagnostic tool. The patients are those arriving to the ED with symptoms of difficulties of~     respiration.~      All patients receive a f-US but only in the intervention group these results will be~     unblinded to the treating physician once he has made his 1. presumptive diagnosis . A final~     presumptive diagnosis has to be made within 4 hours from the patient´s admittance to the ED.~      The correct diagnosis is assessed by a blinded audit of the medical journal. This project~     holds the potential to develop evidence-based optimization of early diagnostic accuracy.~   "
38724|NCT02550171|"~     The BioGene bank: Is a centralized collection of human blood samples along with~     de-identified (coded) health information, environmental factors, family disease histories~     and information from DNA. Limited to the NSLIJHS catchment area.~   "
38725|NCT02550158|"~     This study has the objective to demonstrate that an education program could have a~     significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to~     their disease.~   "
38726|NCT02550145|"~     The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial~     glucose reductions after bariatric surgery in a subset of patients who have severe~     symptomatic hypoglycemia.~   "
38727|NCT02550132|"~     The objective of the present study is to determine if spinal manipulations with a constant~     rate of force application but with different peak force and time to peak force lead to~     similar responses in healthy adults.~   "
38728|NCT02550119|"~     This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without~     aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing~     chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent~     nausea and vomiting in patients treated with chemotherapy. It is not yet known whether~     giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than~     dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.~   "
38729|NCT02550106|"~     Evaluate the proportion of patients with an urticaria control test [UCT] score of greater~     than or equal to 12 at Week 12.~   "
38730|NCT02550093|"~     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The~     vast majority of basic science studies suggested a large effect of oxytocin in minimizing~     acute pain.Few studies have demonstrated an association between plasma levels of oxytocin~     and pain in humans. Since addictive properties of oxytocin have not been described, the drug~     may have important application in the management of acute and chronic pain. No studies have~     examined the effect of intranasal oxytocin on pain sensitivity and threshold.~   "
38731|NCT02550080|"~     This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence~     of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients.~     Those patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous~     skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients~     who need dapsone administration. The study has two (co-primary) objectives: i) to determine~     if screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence~     of clinically-suspected DHS versus current standard of care (no genetic screening) and ii)~     to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a~     significantly lower incidence of immunologically-confirmed DHS versus current standard of~     care (no genetic screening or patch testing). The study consists of up to a 5-day screening~     period, a randomised observation period (Day 1 through Week 6) and, for subjects~     experiencing a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch~     test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms:~     a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic~     Screening Arm (prospective genetic screening: Case). Subjects identified as HLA-B*1301~     positive in the prospective Genetic Screening Arm will not receive dapsone and will be~     excluded from further study. Subjects who experience suspected DHS during the 6-week~     observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.~   "
38732|NCT02550067|"~     The ECHO Study is an open-label randomized clinical trial that will compare three highly~     effective, reversible methods of contraception (including a non-hormonal method) to evaluate~     whether there is a link between use of any of these methods and increased risk of acquiring~     HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO~     will deliver evidence to support and guide individual, policy and programmatic decisions on~     contraception for women at risk of acquiring HIV infection.~   "
38733|NCT02550054|"~     The main goal of this trial is to investigate whether early administration of human~     erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months~     corrected age. This study is designed as randomized, double-masked, placebo controlled~     multicenter study involving at least 312 patients.~   "
38734|NCT02550041|"~     The study aims to asses the ability of cell tests based on the analysis of the~     anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with~     cystic fibrosis.~      In addition, the study will evaluate the contribution of biological classification of~     aspergillosis according to criteria recently proposed by Baxter et al. compared to the~     classification used in clinical practice in the hospital of Montpellier.~   "
38735|NCT02550028|"~     Current treatments for the brain damaging complication of neonatal seizures are~     unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral~     Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures.~     The purpose of this study is to determine the correct oral dosing, safety and efficacy for~     oral Levetiracetam as first line treatment in term new born babies with seizures.~   "
38736|NCT02550015|"~     The purpose of this study is to examine if high intensity interval training after stroke is~     more effective than standard care to increase maximal oxygen uptake, reduce known risk~     factors for recurrent stroke and improve function.~   "
38737|NCT02550002|"~     The primary objective of this study is to test non-inferiority of aflibercept treat and~     extend using a relaxed retinal fluid management relative to aflibercept treat and extend~     using a strict retinal fluid management SD-OCT (spectral domain optical coherence~     tomography) disease activity guided retreatment with respect to best-corrected visual acuity~     (BCVA) from baseline to end of treatment.~   "
38738|NCT02549989|"~     The purpose of this study is to determine the effectiveness of LY3023414 in treating the~     participants type of cancer and to determine the types and severity of side effects caused~     by treatment with LY3023414.~   "
38739|NCT02549976|"~     The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in~     the GETAID centers included in the RAPID study. Secondary objective is to identify~     predictive factors of the evolution digestive damage.~   "
38740|NCT02549963|"~     This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left~     atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular~     atrial fibrillation.~   "
38741|NCT02549950|"~     The purpose of this study is to provide evidence on the effectiveness, the efficiency and~     efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing~     orthodontic treatment time.~   "
38742|NCT02549937|"~     Primary Objective:~      To evaluate the safety and tolerability of sulfatinib in patients with advanced solid tumors~     and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).~      Secondary Objective： To evaluate the pharmacokinetic profile of multiple dose sulfatinib in~     patients with advanced solid tumors and to evaluate the anti cancer activity of sulfatinib~     in patients with advanced solid tumors.~   "
38743|NCT02549924|"~     Type 2 diabetes mellitus [ T2DM ] has quickly become the epidemic of the XXI century and~     challenging global health . Estimates of the World Health Organization [ WHO ] indicate that~     globally , from 1995 to date has nearly tripled the number of people living with diabetes~     mellitus [DM ]. Resveratrol has been extensively studied as a regulator of glucose through~     its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 [~     SIRT1 ] dependent deacetylase nicotinamide adenine diphosphate [ NAD ]. Therefore, it is~     important to know the effect of resveratrol on the glycemic variability [GV ] in patients~     with T2DM who are not in control with metformin monotherapy based.~   "
38744|NCT02549911|"~     Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy~     for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.~   "
38745|NCT02549898|"~     The investigators aim to investigate inflammation of cranial and meningeal arteries during~     pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide~     (USPIO) nanoparticles and black blood imaging (BBI) MRI.~   "
38746|NCT02549885|"~     The purpose of this study is to determine whether the contract-relax technique of~     proprioceptive neuromuscular facilitation, and the static stretching exercise are effective~     in reducing the frequency, intensity and duration of headache and in improving the~     perception of quality of life in women with migraine.~   "
38748|NCT02549859|"~     Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that 60Hz stimulation,~     compared to the traditional 130Hz, decreased the aspiration frequency and swallowing~     difficulty, medication refractory freezing of gait (FOG), and other axial symptoms and~     parkinsonism in Parkinson patients with bilateral STN DBS. The benefit of 60Hz stimulation~     persisted during the 6-week study period, with worsening tremor in one patient. However, it~     remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period,~     and whether there is carry-over effect across different conditions. Clarifying these~     questions is essential for the application of 60Hz stimulation chronically and confidently~     to treat medication refractory axial symptoms. Hence, the investigators would test the~     hypothesis that the 60Hz stimulation, compared to 130Hz, would have persistent benefit over~     an extended period (on average > 8-month study period) in reducing the swallowing~     dysfunction, FOG, and other axial symptoms in PD patients with bilateral STN DBS and~     medication refractory FOG at 130Hz stimulation, even after correcting the potential~     carry-over effects between stimulation conditions.~   "
38749|NCT02549846|"~     Investigators will study whether immediate statin treatment after the onset of stroke is~     beneficial on the neurological protection~   "
38750|NCT02549833|"~     This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which~     surgical resection of the tumor is clinically indicated. Co-primary objectives are to~     determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the~     regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive~     to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected~     glioma.~   "
38751|NCT02549820|"~     CDH is a birth defect characterized by the development, very early in gestation, of a hole~     in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a~     result, the intestines and other organs in the abdomen can move into the chest and press on~     the developing lungs. This prevents the lungs from growing and developing normally.~      In severe cases, CDH can lead to serious disease and death at birth. For these babies,~     treatment before birth may allow the lungs to grow enough before birth so these children are~     capable of surviving and thriving.~   "
38752|NCT02549807|"~     Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP)~     have both muscles spastic and paresis. These movement disorders are likely to cause muscle~     changes both structural and viscoelastic involved in the alteration of neuromotor functions~     such as walking. Therefore, it seems interesting to study the structure of these muscles~     with available imaging techniques. The medial gastrocnemius muscle presents architectural~     characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the~     reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular~     thickness, particularly in children. In addition, the sonoelastometry by Supersonic~     ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which~     allows the calculation of the modulus of elasticity within a muscle tissue. This allows to~     consider new perspectives evaluation of the viscoelastic properties of the muscle. No~     studies have evaluated the reproducibility of this method in adults/children/ adolescent~     after stroke and hemiplegia.~   "
38753|NCT02549794|"~     According to CT technology development, cardiac CT is very useful examination as noninvasive~     examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac~     CT has been performing a gateway role in reducing invasive cardiac angiography implemented~     solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac~     angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid~     being exposed to radiation, so there has been much effort in appealing to reduce exposed~     radiation dose. Of these methods, the most effective is the method of repeatedly~     reconstitution by way of synchronized prospective ECG while using low tube-based potential.~     According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio)~     values representing image quality have been higher compared to the combined method of image~     reconstruction by makeshift filtered back projection and condition of image acquisition by~     patient BMI. Also, the administered amount of contrast agent can be reduced for achieving~     the same contrast effect due to the advantage of the increased effect of contrast~     enhancement by using low tube voltage. Therefore, the efficacy studies of using low~     concentration of contrast agents in conditions of using low tube voltage are being~     processed.~      This study intends to prove that image quality does not deteriorate by suitable image~     reconstruction method with low concentration contrast agent compared to the combined method~     of the makeshift filtered back projection image reconstruction method and the conditions of~     image acquisition according to BMI with general amount of contrast agent.~   "
38754|NCT02549781|"~     In France, the prevalence of problem gambling and risk has been estimated at 1.3%. This~     disorder, currently considered a behavioral addiction is characterized by a loss of control~     and an excessive focus on the game.~      The literature on intervening psychological mechanisms in the development of the game led to~     think that the size of loss of control, central among players, could be understood as a~     reduction in control capacity but also as automatic activation behavior game.~      The task of Go-Nogo, commonly used in cognitive psychology, assesses the automatic and~     controlled components of behavior. Furthermore, different models of the concept of addiction~     underline the importance of the environment associated with addiction. However, no study~     takes into account the interaction between the game environment and the involvement of these~     mechanisms.~   "
38755|NCT02549768|"~     Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its~     relation to cortisol levels during postoperative period.~   "
38756|NCT02549755|"~     It is thought that PET of the abdomen with 11C Acetate will provide new information~     regarding whether or not patient's have benefited from radiotherapy. To test this theory,~     the project will evaluate the potential of 11C acetate to serve as an earlier and/or better~     signal of treatment success.~   "
38757|NCT02549742|"~     A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck~     cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging.~     Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation~     and side effects to treatment.~   "
38942|NCT02547324|"~     This is a prospective, single-blinded, randomized-controlled study comparing a new method~     (slump-sitting) with the conventional method (forward erect bending) of performing lumbar~     spine flexion X-rays.~   "
38760|NCT02549703|"~     While the last several years have seen great strides in the treatment of relapsing forms of~     MS, progressive MS, responsible for the majority of MS-related disability, lags far behind.~     Despite much research, the lack of understanding related to what causes patients' relentless~     decline in function results in an inability to develop targeted treatment strategies~     suitable for clinical trials. This grant has two main goals.~      The first goal is to extend the investigators preliminary study on rat neurons treated with~     the CSF of MS patients to a larger number of Progressive patients in order to validate the~     initial findings and extend the study to include analysis of human neurons. The initiating~     PI (Dr. Casaccia) and the Partnering PI and Clinical Neurologist (Dr. Katz Sand) have~     recently identified components that are present in the CSF of progressive patients that~     impair the ability of rat neurons to produce energy. The partnering PI, Dr. Quinzii~     (Columbia University) together with collaborator Dr. Fossati (NY Stem Cells Foundation),~     have characterized human neurons generated from stem cells derived from skin biopsies of~     progressive patients and detected the presence of energetic deficits. The experimental plan~     will build on these results and test hypotheses of disease progression. The overall goal is~     to improve understanding on how to stop neurons from degenerating and stop clinical~     progression.~      The second goal is to ask whether it is possible to define a progressive disease course on~     the basis of combined biochemical, functional and imaging measurements. The initiating PI~     will be responsible for the biochemical assessment of CSF and serum samples and, together~     with partnering PI Quinzii, will also provide functional bioassays measurements of~     mitochondrial bioenergetics impairment in patients. These data will be combined with~     clinical assessment and MRI evaluations conducted by the partnering PI Katz Sand and~     collaborator Inglese. A two year clinical and imaging follow up from the initial recruitment~     will allow to define whether the combined measurements can be used by clinical neurologists~     to define the disease course and better identify therapeutic options for patients.~      The expectation is that the completion of the stated aims of research will allow an~     advancement of the current knowledge of the progressive form of MS and lead to potential new~     therapeutic targets.~   "
38761|NCT02549690|"~     The main purpose of this study is to compare the number of oocytes retrieved after using~     transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for~     6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization~     (IVF).~   "
38762|NCT02549677|"~     The purpose of this study is to compare the safety and efficacy of epirubicin plus~     cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node positive, estrogen~     receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast~     cancer patients as adjuvant chemotherapy.~   "
38763|NCT02549664|"~     The goal is to determine how lifestyle and exercise impact the well-being of individuals~     with hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).~   "
38764|NCT02549651|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736~     alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed~     or refractory dIffuse large B-cell lymphoma.~   "
38765|NCT02549638|"~     The study will utilize both retrospective and prospective data collection from patients that~     already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection~     for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic~     biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients~     who meet the study criteria.~   "
38766|NCT02549625|"~     The objective of this study is to determine the safety and feasibility of autologous~     mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for~     individuals with declining ventricle systemic pumps. This procedure has the potential to~     foster a new strategy for congenital heart patients. This is an open-label study of~     autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related~     serious adverse events and 2) monitor changes in cardiac structure and function.~   "
38767|NCT02549612|"~     Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis~     media (AOM). It is usually associated with 5-15 deci Bells hearing loss. Although~     spontaneous resolution with normalisation of hearing is the usual outcome, this can take~     several months. Secretory otitis media is the most common cause of hearing impairment in the~     paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6~     months or more, surgery with tympanostomy tube insertion under general anaesthesia is~     indicated. In Sweden, 10000 children undergo this operation annually. Although many children~     with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the~     autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns~     2005.~      In two previous studies, the investigators concluded that the nonsurgical treatment method,~     that was developed to assist children with SOM equalising their middle ear pressure, could~     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.~     These children avoided therefore grommet insertion.~      The investigators would like to assess the effect of this new treatment method on hearing~     directly after AOM. The investigators expect that using the new method could rapidly~     normalise hearing in these cases and thereby operation with grommet insertion could be~     avoided.~   "
38768|NCT02549599|"~     The primary aim of the proposed project is to conduct a randomized controlled trial to~     evaluate the efficacy of a digital intervention tool that enables young people to correspond~     with trained staff via online chat or text messages about urgent questions related to~     sexual/reproductive health.~   "
38769|NCT02549586|"~     This open-label, proof-of-principle two center cohort study will evaluate the ability of~     autologous hematopoietic stem cell transplantation to induce tolerance in recipients of~     deceased or live donor liver transplants (ASCOTT). A maximum of 10 participants will be~     entered at a minimum of 3 months post liver transplant. The participants will undergo~     autologous hematopoietic stem cell transplants (HSCT) to re-educate their immune systems~     to accept the graft without the need for long term immunosuppression (tolerance).~   "
38770|NCT02549573|"~     To determine if PT intervention will be improved while in the on motor state vs. the~     end-of-dose-off motor state during the PT Intervention Visit in subjects with PD.~   "
38771|NCT02549560|"~     Postoperative cognitive dysfunction (POCD) is a contrary event observed between 20 to 83%,~     especially on elderly and patients submitted to cardiac surgery. The prevention and~     rehabilitation on cases of POCD can improve the quality of life and decrease the mortality~     in surgical patients. The effect of the noninvasive cerebral stimulation, also known as~     transcranial Direct Current Stimulation (tDCS) has been studied to be used in the treatment~     of brain injuries and depression, and also in the cognitive rehabilitation. The hypothesis~     is that the use of the tDCS technique can decrease the occurrence of POCD and cognitively~     rehabilitate patients submitted to cardiac surgeries.~   "
38808|NCT02549079|"~     The present study investigates the levels of certain soluble factors in the blood of~     patients with severe burn injury. Serum levels of different soluble factors will be~     correlated with the clinical outcome, presence of sepsis, the area of burn, and other~     clinical parameters in order to make a statement regarding their use as biomarkers in the~     prediction and monitoring of burn patients.~   "
38772|NCT02549547|"~     The WHO, the Pan American Health Organization, the EU Council of Ministers, the World~     Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -there can~     be no health without mental health. Within Canada, 6.7M people live with a mental illness~     and when family and caregivers are included almost everyone is affected.~      A systematic review (2014) concluded that physical activity has a significant potential for~     reducing depressive symptoms in people with a mental illness. Globally, physical inactivity~     is pandemic. Current guidelines recommend a minimum of only a 150 minutes a week of~     moderately vigorous exercise but 85% of Canadians do not meet the national recommendations.~     How then can people with depression be motivated to become physically more active?~      Group Medical Visits (GMVs) can be used to provide health services and they have proven~     effective in some settings, including mood disorders. As well as providing economic and~     resource efficiencies, the GMV model has the potential to add a 'support~     group/accountability' element for behavioural interventions such as physical activity~     promotion; such influence is not present in an individual patient-physician consultation.~      Jump Step is a 14-week program within a GMV setting designed to motivate and support~     people with depression to engage in regular physical activity. The investigators seek to~     design, implement, and evaluate the effectiveness of the Group Medical Visits focused on~     promoting physical activity for patients with depression.~   "
38773|NCT02549534|"~     Purpose: The purpose of the study is to test a new way of measuring nerve damage in women~     with breast cancer receiving chemotherapy drug paclitaxel (Taxol).~   "
38774|NCT02549521|"~     Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The~     main storage place for magnesium is in the bone. Magnesium is direct under calcium in the~     periodic system making it possible to interact with the crystal structure. Some small~     studies have shown beneficial effects of magnesium substitution on osteoporosis. Evidence~     has shown improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It~     has been uncertain however, which of these factors can contribute to such a change. The~     effect of magnesium substitution 240 mg daily as therefore studied in two parallel groups~     where both received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got~     placebo and the other received magnesium. This was studied on various expressions for bone~     metabolism after zero, seven and 28 days in elderly females aged 70 years old.~   "
38775|NCT02549508|"~     The purpose of this research is to examine the application of AutoCPAP with and without~     SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate~     whether patients achieve better sleep quality and compliance with SensAwake, compared to the~     same treatment without SensAwake.~   "
38776|NCT02549495|"~     This study evaluates the effectiveness of community health workers when added to routine~     care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico.~     It does so by recording information on adherence to therapy, blood pressure and blood sugar~     while a non-governmental organization working in Mexico trains and introduces a community~     health worker program.~   "
38777|NCT02549482|"~     13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask~     fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to~     measure blood pressure and thus systolic pressure variation and pulse contour analysis~     determined stroke volume and thereby cardiac output in order to detect a central volume~     deficit.~   "
38778|NCT02549469|"~     Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3~     different sustained release formulations of naproxen 660 mg relative to the established~     commercial Aleve 220 mg tablet.~   "
38779|NCT02549456|"~     The purpose of this study is to assess different hybrid natural orifice transluminal~     endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of~     the technique, short term oncologic outcome and functional outcome.~   "
38780|NCT02549443|"~     This study evaluates whether providing a nutritional intervention in the form of insulin,~     sugar and protein during and after open-heart surgery will increase the body's protein~     stores and maintain a normal level of blood sugar. The primary outcome will be Whole body~     protein balance which will be assessed by isotope tracer kinetics. Protein balance will be~     calculated as protein synthesis minus protein breakdown with positive values indicating~     anabolism and negative values catabolism. The preoperative measurements will be performed on~     the morning before the operation. Postoperative studies will be conducted two hours after~     surgery in the intensive care unit. Patients will be followed for 12 hours after surgery.~   "
38781|NCT02549430|"~     This study aims to assess the activity of PD0332991 in monotherapy and in combination with~     the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the~     patient has progressed in the previous line for advanced breast cancer in order to reverse~     endocrine resistance.~   "
38782|NCT02549417|"~     This study is designed to evaluate efficacy and safety of KHK7580 orally administered once~     daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal~     dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week~     extension period to evaluate long-term safety and efficacy.~   "
38783|NCT02549404|"~     This long-term study is designed to evaluate safety and efficacy of KHK7580 orally~     administered once daily for 52 weeks for patients with secondary hyperparathyroidism~     receiving hemodialysis.~   "
38784|NCT02549391|"~     The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally~     administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT)~     receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment,~     parallel-group design with cinacalcet hydrochloride as an active control.~   "
38793|NCT02549274|"~     The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is~     most often based on analgesics combined with physical therapy. More recently authors have~     advocated the use of self-rehabilitation, that is to say, the use by the patient himself of~     physiotherapy exercises to perform at home regularly. However, if there are currently many~     studies on the effectiveness of self-rehabilitation for low back pain, there are few data on~     neck pain.~      In this context we have chosen to implement a prospective, randomized study, on the~     effectiveness of self-rehabilitation in patients with chronic neck pain.~   "
49410|NCT02410382|"~     This study will look at how dexamethasone and placebo influence radiation fatigue, quality~     of life and number of treatment days missed during radiation therapy or radiation therapy~     and chemotherapy for cancer.~   "
38785|NCT02549378|"~     The microcirculatory alterations is common in circulatory failure, especially during sepsis.~     The severity of these changes and their sustainability are responsible of multi organ~     failure and ultimately death. The optimization of microcirculatory flow could be a central~     objective of the management of patients hospitalized in intensive care.~      Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It~     represents the largest heat exchange surface of the body and is involved in tissue~     oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and~     blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...).~     The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of~     our team and the oldest work in the literature lead to believe that CO2 has a specific role~     in modulating microcirculatory flow. No study to date precisely studied the impact of~     changes in the microcirculatory flow carbonemia .~      The hypocapnia test is carried out in a standardized manner by inhalation of a mixture~     enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn~     obtained by a calibrated voluntary hyperventilation test.~      Direct visualization of microcirculation by confocal microscopy is now considered the gold~     standard for exploring the microcirculation.~   "
38786|NCT02549365|"~     The UK Departments of Health now recommend annual influenza vaccination for all children 2-7~     years of age, with children over 7 years eligible for vaccination if in certain higher risk~     clinical categories. Though data are available documenting the safety and immunogenicity of~     LAIV in this age group, there are little data to assess efficacy and immune correlates in UK~     children, and in particular atopic children. This study will enrol 200 children (and at~     least 200 unvaccinated household sibling controls), many with a history of asthma or~     recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in~     these children, and how this varies with prior administration of pandemic influenza vaccine~     and/or LAIV.~   "
38787|NCT02549352|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive~     days as field treatment~   "
38788|NCT02549339|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days~     as field treatment~   "
38789|NCT02549326|"~     Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD)~     concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A~     direct assay for free 25OHD was introduced recently.~      The aim of the study was to evaluate differences in vitamin D metabolism between young~     adults with severe childhood-onset obesity and normal-weight controls. Half of the obese~     subjects and controls will receive placebo and the other half will receive vitamin D3 50 µg~     daily for 12 weeks.~   "
38790|NCT02549313|"~     The position of the head of the patient influences the cerebral venous return and cerebral~     perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a~     Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on~     precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure~     (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC.~     Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem~     unaffected by changes of position of the head of the patient. But the whole of the~     literature on this subject has significant bias.~   "
38791|NCT02549300|"~     The purpose of this study is to investigate the effects of connective tissue massage and~     lifestyle modifications in adolescents tension type headache, pain severity, pain duration,~     pain frequency and quality of life and pressure pain threshold rates. The patients will be~     accepted to study according to 'The International Classification of Headache Disorders-III'~     criteria. Including criteria are; being between 10-19 ages adolescents, suffering from~     tension type headache at least for 6 months, pain severity between 4-7 on visual analog~     scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic~     accident, head trauma and any kind of neurological disorder. Patients will be divided into~     two groups randomly. The investigators plan to receive 30 patients to the study. 15 of them~     will be in control group, 15 in study group. Control group will just receive some advices~     including life style modifications, like using right glasses, not smoking, true posture~     habits and regular and quality sleep habits. In addition to life style modifications, the~     other group will be treated with connective tissue massage. Connective tissue massage will~     be applied on basic part, lower thoracic, scapular, inter scapular and neck regions, 5 times~     a week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes.~     Patients detailed medical history and demographic data will be recorded. Pain severity,~     duration, frequency, analgesic usage, connective tissue evaluation of back, range of motion~     of neck, pressure pain threshold for pain sensitization measurements and quality of life~     will be evaluated before treatment and after 4 weeks of treatment.~   "
38792|NCT02549287|"~     The purpose of this study is to conduct an effectiveness trial of the SafeCare model for~     parents with substantiated maltreatment. SafeCare, a behavioral parenting program will be~     compared to supportive case management (SCM), which is a process oriented service aimed at~     building rapport, providing family support, crisis management, and provision of referrals to~     additional services. The SafeCare model is a promising intervention for child maltreatment,~     but has not been broadly compared to usual services across a variety of service setting, and~     it has not been evaluated with respect to client outcomes of well-being, or service delivery~     burden, satisfaction, and perceived effectiveness. The study aims are as follows:~      (1) Compare SafeCare to SCM on parent and child outcomes including parenting skill,~     parenting stress and emotional well-being, parent-child relationship, parent and child~     well-being, and child adaptive behavior. (2) Compare SafeCare to SCM on how families and~     providers perceive each intervention, specifically with regard to burden, satisfaction, and~     program impact. (3) Compare SafeCare to SCM on ability to reduce child welfare re-reports.~     (4) Examine variability in SafeCare effects across sites and client characteristics.~   "
38867|NCT02548299|"~     This study is a multi-dimensional therapeutic lifestyle program that offers cooking and~     nutrition education as well as email-based health coaching to diabetic patients in an~     underserved Cleveland community. This is an innovative project as it is one of the first~     focused efforts within this community to improve diabetes control and prevent diabetes~     progression through cooking and nutrition as well as to systematically measure both clinical~     and behavioral outcomes.~   "
38795|NCT02549248|"~     Nanoparticles (NP) are particles whose length, width and height are less than 100~     nanometres. Over the past decade, industrial applications of NP have increased dramatically.~     Despite their widespread use, their true impact on human health remains unknown and poorly~     studied. NP exposure in humans primarily occurs via inhalation through the respiratory~     system. The aim of this study is to estimate the relationships between the nanoparticle load~     in the lung and bronchi and some interstitial lung diseases. In the aftermath of human~     exposure to asbestos, the pathological consequences of environmental exposure to~     nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.~   "
38796|NCT02549235|"~     The purpose of this trial is to evaluate the morphological characteristics of the uterus~     with three-dimensional ultrasound (3DUS) at the time of embryo transfer in women undergoing~     IVF/ICSI treatment and correlate it to clinical outcomes. The uterus will be assessed in the~     3D coronal plane and measurements including the fundal wall thickness, fundal wall~     indentation and interostial distance will be performed to assess whether they correlate with~     clinical pregnancy rate, miscarriage rate and live birth rate.~   "
38797|NCT02549222|"~     This study is a prospective, non-randomized sequential cohort, open label, multi-center,~     non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The~     patient population will be hematology-oncology patients, including those undergoing~     hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.~      For each participating center, the study will start with a brief pilot run-in period with a~     group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot~     run-in is to evaluate study logistics and data collection methods within each study center.~     Data from the pilot phase will be included in the data listings but not included for the~     treatment comparison.~      After the pilot run-in period, the study will be conducted in two sequential patient~     cohorts: 1) the Control cohort during which study patients will receive only conventional~     PCs, and 2) the INTERCEPT cohort during which patients will receive only INTERCEPT PCs.~     Patient enrollment at each Center will be monitored to target similar numbers of patients~     into the Control and Test Cohorts within each center. Within each Center, patient enrollment~     will be stratified in four categories: (1) chemotherapy only; and by use of conditioning~     regimens for hematopoietic stem cell transplantation (HSCT) in (2) myeloablative~     conditioning, (3) non-myeloablative conditioning, and (4) reduced intensity using the Center~     for International Blood and Marrow Transplant Research (CIBMTR) criteria. To ensure both~     Test and Control cohorts have a similar allocation ratio (±10% per category) among the~     conditioning regimen strata, enrollment caps will be set for the Test cohorts, hence no Test~     patients will be enrolled to a stratum once the cap for the given stratum is met.~   "
38798|NCT02549209|"~     This is a single-arm, open-label, multi-center phase II study for subjects with measurable~     advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin~     and paclitaxel chemotherapy. As this combination of agents has not been tested in this~     subject population, the first six subjects enrolled will constitute a safety run-in cohort.~   "
38799|NCT02549196|"~     This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's~     type to determine the optimal dose titration schedule.~   "
38800|NCT02549183|"~     Clinical study to estimate the optimal frequency for stimulation of the spinal cord to~     achieve relief from back pain.~   "
38801|NCT02549170|"~     This is a Phase III, prospective, multicenter study with two study parts (epochs) to~     evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant~     human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to~     prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV)~     10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll~     adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing~     regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval~     of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this~     double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be~     randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution~     with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6~     months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive~     IGIV treatment for a period of 6 months.~   "
38802|NCT02549157|"~     The research aims to assess the relationship between treatments for a range of~     urogynaecological problems (pelvic floor dysfunction, cancers) and patient reported values,~     psychological states, and quality of life. The impact of treatments on the patients' health~     outcomes will be measured, using specific urogynaecological outcome measures (for either~     pelvic floor dysfunction or cancer), and patient reported measures of general health and~     quality of life. Patients' psychological states and values will be measured by validated~     self report instruments for these areas. Researchers will obtain consent for participation~     from patients. Following consent, baseline measures will be taken at the patients' routine~     appointment about 4weeks prior to undergoing treatment (e.g., surgery or physiotherapy for~     pelvic floor dysfunction, or surgery for a urogynaecology cancer). These measures will be~     the routinely collected physical data obtained by medical staff, and patient reported~     measures of their general health (GHQ28), psychological state (HADS; PVQII), and quality of~     life (EuroQual5D, WHOQoLBREF, QRS, QLQC30). These questionnaires should take about 30~     minutes to complete, in total. The patients will then undergo their treatment (physiotherapy~     programme or surgery), which will not be affected in any way by this research. Researchers~     will obtain consent for participation from patients. Following consent, baseline measures~     will be taken at the patients' routine appointment about 4 weeks prior to undergoing~     treatment (e.g., surgery or physiotherapy for pelvic floor dysfunction, or surgery for a~     urogynaecology cancer). These measures will be the routinely collected physical data~     obtained by medical staff, and patient reported measures of their general health (GHQ28),~     psychological state (HADS; PVQII), and quality of life (EuroQual5D, WHOQoLBREF, QRS, EORTC~     QLQC30). These questionnaires should take about 30 minutes to complete, in total. The~     patients will then undergo their treatment (physiotherapy programme or surgery), which will~     not be affected in any way by this research. About four weeks post treatment, patients will~     receive their usual appointment, and routinely collected physical data will be obtained by~     medical staff, and patients will complete the measures as described above. With the~     patient's consent, the above evaluation will be repeated at every follow-up appointment that~     the patient has (i.e. after 3months, and then at yearly intervals, for 5 years). The impact~     of treatments on objective routine health measures taken by medical staff, and on patient~     reported measures of health, quality of life, personal values, and psychological~     functioning, will be documented at each measurement point. Additionally, relationships~     between psychological states/values and both objective and subjective ratings of how~     treatments have impacted the patients will be established.~   "
38803|NCT02549144|"~     In this study the investigators aimed at measuring the effect of a two-week~     high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition~     and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.~   "
38804|NCT02549131|"~     The purpose of this randomized controlled prospective trial is to guide physicians on the~     most effective evidenced based skin closure during a cesarean section for the obese gravida,~     defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular~     sutures and surgical staples.~   "
38805|NCT02549118|"~     The aim of this study is to assess whether tenoxicam is as effective as pethidine for~     analgesia during the first stage of labor.~   "
38806|NCT02549105|"~     A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration~     with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.~   "
38809|NCT02549066|"~     Cardiac surgery with cardiopulmonary bypass (CPB), especially when oxygen delivery is low,~     is associated with acute kidney injury. Unpublished data shows that renal oxygen delivery is~     compromised during CPB due to low hematocrit and redistribution of blood flow away from the~     kidneys. We wish to study if increased CPB flow can improve renal oxygenation.~      Patients who develop cardiac failure after weaning from CPB will be treated as per our~     departments routine with the inotropic agent milrinone, and measurements will be made before~     and after treatment.~   "
38810|NCT02549053|"~     The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV)~     was increased in patients with Barrett esophagus compared with controls in a prospective~     study. Secondary objective was to identify, if present, the type of Human PapillomaVirus~     (HPV) associated in Barrett esophagus.~   "
38811|NCT02549040|"~     This study aims to evaluate and compare the relative bioavailability of different MK-1439~     experimental nano formulations (NFs) with that of a MK-1439 film coated tablet.~   "
38812|NCT02549027|"~     The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study~     is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS)~     as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the~     safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male~     participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is~     superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.~   "
38813|NCT02549014|"~     The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the~     safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in~     healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least~     one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064~     plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment~     of MK-1064 in humans, the study protocol allows for modifications to the outlined dose,~     dosing regimen and/or clinical or laboratory procedures, if required to address study~     objectives and/or to ensure appropriate safety monitoring of participants.~   "
38814|NCT02549001|"~     The purpose of this study is to determine whether P-3058 nail solution is a safe and~     effective treatment for onychomycosis.~   "
38815|NCT02548988|"~     The purpose of this study is analyze the immediate effect of selective neuromuscular~     electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO~     and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral~     pain syndrome.~   "
38816|NCT02548975|"~     This study will evaluate several potential risk factors for postoperative delirium in~     cardiac surgery patients. The risk factors will include use of specific preoperative,~     intraoperative, and/or postoperative medications. Other risk factors investigated may~     include exposure to cardiopulmonary bypass, surgical technique, and or duration of surgery.~   "
38817|NCT02548962|"~     Phase 1 will be an open-label, dose finding, multicenter study of ibrutinib in combination~     with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.~      Phase 2b will be conducted as a randomized, double-blind, multicenter study of ibrutinib or~     placebo, in combination with pomalidomide and dexamethasone in subjects with~     relapsed/refractory multiple myeloma.~   "
38818|NCT02548949|"~     On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in~     Korea. In accordance with the Standards for Re-examination of New Drug, it is required to~     conduct a PMS for 600 patients by 5 Feb 2020. Post marketing surveillance is required to~     determine any problems or questions associated with Pristiq after marketing, with regard to~     the following clauses under conditions of general clinical practice. Therefore, through this~     study, effectiveness and safety of pristiq will be observed.~   "
38819|NCT02548936|"~     This is a randomized single-blind trial. This study aimed to determine if intensive~     lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the~     progression of atherosclerosis effectively and safely among SLE patients with carotid artery~     intima thickening. The study results were expected to be helpful for SLE patients in~     preventing atherosclerosis.~   "
38820|NCT02548923|"~     The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for~     prolonged sedation in trauma and surgical patients.~   "
38821|NCT02548910|"~     Major liver resection is associated with substantial intraoperative blood loss. Blood loss~     in elective liver surgery is a significant factor of perioperative morbidity and mortality,~     as well as possibly long-term oncologic outcome. The purpose of this study is to use whole~     blood phlebotomy to decrease the central venous pressure, resulting in a state of relative~     hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss~     at the time of liver resection.~   "
38822|NCT02548897|"~     The purpose of this study is to investigate brain signals related to freezing of gait (FoG),~     a symptom of Parkinson's Disease, that can lead to dangerous falls. The investigators~     hypothesize that uncovering these signals can lead to better deep brain stimulation~     interventions.~   "
38823|NCT02548884|"~     The purpose of the study is to compare two different techniques (pancreatic sphincterotomy~     (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and~     the success of cannulation in difficult cannulation. For the study, the difficult~     cannulation is de-fined as situation when the common bile duct has not been cannulated in~     five minutes, after five attempts or after two pancreatic guide wire passages or when any of~     those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random~     fashion. The primary end-point is the risk of PEP .~   "
38824|NCT02548871|"~     The purpose of this study was to determine the impact of TOP® on sexual health behavior.~   "
38825|NCT02548858|"~     The purpose of this study is to determine whether performing a perineorrhaphy during a~     reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body~     image.~   "
38826|NCT02548845|"~     In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the~     treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone~     (SIADH) in oncology patients was developed. Since it is hypothesised that the adherence to~     the SEOM algorithm is not 100%, the current retrospective non-interventional study will~     investigate the perceived and actual adherence of participating centres to the SEOM~     algorithm and its impact on patient outcomes~   "
38827|NCT02548832|"~     Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has~     increased over the last decade. Part of the components of metabolic syndrome and consensus~     so far contemplated to increased triglycerides and reduced HDL-C as part of the elements for~     classification, which includes mixed dyslipidemia.~      Currently fibrates, such as bezafibrate, are drugs whose utility in treating~     hypertriglyceridemia is fully proven, besides reducing the risk of coronary disease.~     However, although this treatment is safe, it is not without risks; with increased prevalence~     of adverse effects as the dose thereof is increased or joins combination with a statin drug~     for the treatment of mixed dyslipidemia long term.~      Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides~     may be useful in combination with the bezafribrato in the treatment of mixed dyslipidemia~     and as an option with lower cost and lower frequency of adverse events.~   "
38828|NCT02548819|"~     A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic~     magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and~     implantable cardioverter defibrillators).~   "
38829|NCT02548806|"~     The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg~     and 100 μg Clonidine and comparative bioavailability of clonidine with that from the~     Reference drug, Catapres® 100 μg oral tablets following single dose administration in~     healthy subjects.~   "
38830|NCT02548793|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival~     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than~     one third of witnessed SCA events. A number of barriers to bystander CPR training have been~     identified including time and cost of the training course. Since the large majority of~     arrest events occur in the home environment, studies have suggested that providing CPR~     training to family members of hospitalized cardiac patients may serve as a useful approach~     to address an environment in which bystander CPR is frequently not provided. Utilizing an~     existing in-hospital program to train adult family members, the investigators will assess~     the skills of those who learn CPR through two different educational methods: a mobile app~     and video self-instruction (VSI).~   "
38831|NCT02548780|"~     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and~     efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable~     HCC.~   "
38832|NCT02548767|"~     It is not known whether consumption of excessive amounts of sugar can increase risk factors~     for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and~     weight gain, nor whether the negative effects of sugar consumption are made worse when~     accompanied by weight gain. This study will investigate the effects of excess sugar when~     consumed with an energy-balanced diet that prevents weight gain, and the effects of excess~     sugar when consumed with a diet that can cause weight gain. The results will determine~     whether excess sugar consumption and excess caloric intake that lead to weight gain have~     independent and additive effects on risk factors for cardiovascular disease or diabetes, and~     will have the potential to influence dietary guidelines and public health policy.~   "
38833|NCT02548754|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental~     studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at~     voltages substantially below that which slowed the sinus rate, significantly suppressed AF~     inducibility and decreased AF duration. The investigators subsequently developed a~     non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch~     of the VN located at the tragus, the anterior protuberance of the outer canine ear (low~     level tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those~     of LLVNS delivered to the cervical VN trunk. More recently, in a proof-of-concept study in~     humans, the investigators showed that in patients with drug-refractory AF undergoing AF~     ablation, LLTS for just one hour significantly shortened the AF duration and decreased~     inflammatory cytokines.~      The overall objective of this proposal is to translate in ambulatory patients with~     paroxysmal AF the results of previous studies showing acute suppression of AF and~     inflammation in anesthetized canines as well as humans, in order to examine the long-term~     therapeutic effects of this approach. The investigators hypothesize that intermittent (1~     hour daily) LLTS for 6 months may result in long-term decrease of AF burden and suppression~     inflammatory cytokines in patients with paroxysmal AF. Patients will be randomized to either~     active or sham LLTS. LLTS will be delivered through a transcutaneous electrical nerve~     stimulation (TENS) device for 1 hour daily over a 6-month period. AF burden will be defined~     as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous~     ECG monitoring at baseline and at 6 months. In addition, blood samples will be collected~     from patients at baseline, and at 3 and 6 months, for cytokine measurement. These~     investigations will establish the first evidence of the long-term effects of LLTS on AF~     suppression in patients with paroxysmal AF and may provide the basis for a potential~     expansion of the therapeutic targets of this treatment modality beyond AF.~   "
38834|NCT02548741|"~     This study is designed to investigate the effects of metformin, a commonly prescribed first~     line medication for diabetes and recommended for prediabetes, on the levels of the~     potentially tissue damaging reactive product (MG) in the blood and its cleared counterpart~     in the urine (IMZ). The study will involve patients with elevated HbA1c randomized to~     receive either metformin or a similar inactive placebo pill and a group of sex and age~     matched volunteers without diabetes. Study participants will be recruited from the~     University of Arizona Medical Center, South Campus clinics (Endocrine clinic, family~     medicine clinic and general medicine clinic). Eighty patients with HbA1c >6.0% will be~     randomized to receive either metformin or a similar inactive placebo for 6 weeks. The~     response of these patients will be compared to 40 patients normal HbA1c <5.6% who will not~     receive either study medication. Investigators will compare the plasma MG and urine IMZ~     concentration/content between the 3 groups before and after the 6-week intervention. It is~     hypothesized that plasma MG level in the metformin treatment group will be less than in the~     group taking the placebo pills, while there will be no significant difference in MG level~     between the metformin treatment group and the volunteers without diabetes.~   "
38835|NCT02548728|"~     Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases~     use of and cravings for opioids (narcotics) in people who have been using opioids heavily~     for long periods of time and are unable to stop on their own.~      Participants: Patients meeting DSM-IV-TR criteria for opioid dependence.~      Procedures (methods): Subjects will have standard medications available for withdrawal~     symptoms from opioids and standard psychosocial interventions available in the inpatient~     setting. In addition, subjects will self-administer intranasal test treatments 3 times~     daily.~   "
38868|NCT02548286|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with~     coadministration of the two separate drugs in healthy male volunteers.~   "
38869|NCT02548273|"~     This study aims to assess the corneal damage after phacoemulsification and to assess the~     factors causing it in diabetics in comparison with non-diabetics.~   "
38836|NCT02548715|"~     Patients that require treatment for cancers of the head and neck often require a combination~     of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common~     complications, and has been associated with post-operative complications such as wound~     healing problems, fistula formation, and decreased quality of life and survival. Several~     studies have examined hypothyroidism after radiation to the head and neck, but few have~     examined this after non-thyroid head and neck surgery. Head and neck resection is theorized~     to devascularize the thyroid, thus resulting in post-operative hypothyroidism.~      Synthroid is a synthetic thyroid hormone often used in cases of patients with proven~     hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied~     for over fifty years.~      Treatment algorithms for hypothyroidism are well published. However, treatment of~     subclinical hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial.~     The rate of subclinical hypothyroidism after non-thyroid head and neck surgery is high (up~     to 20%), and is associated with post-operative complications as noted above.~      Therefore the investigators propose a double blinded randomized controlled trial comparing~     outcomes of patients that develop subclinical hypothyroidism after head and neck surgery,~     who are given a standardized dose of synthroid treatment versus those treated with placebo.~     The main outcomes to be examined are post-operative complications (wound healing issues,~     fistula formation), survival, and quality of life measures.~   "
38837|NCT02548702|"~     The Fit4Life intervention aims to engage inactive patients with type 2 diabetes in a~     community-based sport intervention, with the aim being that all participants complete 1 x 30~     min session of physical activity/exercise per week across the 12 months they are involved in~     the intervention (total study duration 3 years).~      The aim of the Fit4Life intervention is to slow the progression of disease symptoms and to~     improve quality of life in those diagnosed with type 2 diabetes. The aim of this research~     study is thus to evaluate the effectiveness of the intervention in achieving these aims. The~     hypothesis is that involvement in the Fit4Life programme will increase physical activity,~     reduce type 2 diabetes disease symptoms and enhance self-reported quality of life in male~     and female patients aged 35-64.~   "
38838|NCT02548689|"~     This study will investigate whether subjects who suffer from hair loss have increased levels~     of PAI-1 compared to age-matched control subjects. The level of PAI-1 expression will be~     determined in subjects without hair loss and in subjects with non-scarring hair loss,~     including androgenetic alopecia, telogen effluvium and alopecia areata.~   "
38839|NCT02548676|"~     Glaucoma is one of the leading causes for blindness in industrialized countries. It is~     characterized by a progressive loss of retinal ganglion cells, morphological changes in the~     optic nerve head and a characteristic loss of visual field. It has been speculated for a~     long time that vascular factors may also contribute to the pathogenesis of the disease. This~     concept has been supported by several epidemiological studies showing that small retinal~     vessel calibre are associated with the disease. In the recent years tremendous enhancements~     in the field of optical coherence tomography has been achieved. These developments made it~     possible to visualize the retinal vasculature in a full depth manner without the application~     of an intravenous marker. The proposed study tests the hypothesis that patients with~     glaucoma show altered vascular morphology compared to healthy subjects. This is of~     importance because it may clarify the degree of vascular involvement in glaucoma.~   "
38840|NCT02548663|"~     This project assessed muscle oxidative metabolism and fatigue in patients affected by~     amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized~     cardiovascular and strength training. Muscle oxidative metabolism and strength will be~     assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and~     mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen~     extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit~     recruitment and related fatigue. The investigators will also assess the effects of training~     on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill~     Quality of Life questionnaires, using the validated Italian versions. Patients will be~     assessed longitudinally before (time T0) and after three months of individualized training~     (time T1). After one month of de-training (time T2) the investigators will assess the~     hypothetic persistence of any treatment-related effect. The effect of three~     months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.~   "
38841|NCT02548650|"~     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more~     frequently clopidogrel, represents the standard of care for the long-term secondary~     prevention of atherothrombotic events in patients with myocardial infarction (MI). However,~     rates of ischemic recurrences remain high. Vorapaxar is a protease-activated receptor~     (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation.~     Patients with diabetes mellitus (DM) are known to be at increased risk of recurrent~     atherothrombotic events, which translates into worse outcomes, despite the use of standard~     of care therapy. This is in part due to the hyperreactive platelet phenotype, which~     characterizes DM patients, and to inadequate response to oral antiplatelet agents, including~     clopidogrel. Therefore, vorapaxar is an attractive treatment option for DM patients with a~     prior MI. The pharmacodynamic (PD) effects of vorapaxar in DM patients and how these may~     differentiate from non-DM patients has not been explored. Further, the role of vorapaxar as~     part of a dual antithrombotic treatment regimen combined with clopidogrel (and stopping~     aspirin) represents another important area of clinical interest. The proposed prospective,~     parallel-design study conducted in post-MI patients with and without DM will aim the assess~     the pharmacodynamic effects of vorapaxar in addition to standard DAPT with aspirin and~     clopidogrel as well as in combination with clopidogrel only following aspirin withdrawal.~   "
38842|NCT02548637|"~     Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health~     Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients~     being treated with aromatase inhibitor (AI) therapy for breast cancer and whether the~     reduction in pain happens by lowering inflammation.~   "
38843|NCT02548624|"~     The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in~     measuring position changes of a non-patient subject in a lab setting and to examine the~     effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.~   "
49411|NCT02410369|"~     In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in~     patients who underwent an adjuvant chemotherapy after the complete resection of~     non-small-cell lung cancer.~   "
38844|NCT02548611|"~     Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary~     interventions is associated with improved outcomes after coronary stenting. However the~     onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if~     very variable. A way to overcome this limitation is loading with a more potent antiplatelet~     drug such as prasugrel. Therefore in the current study the investigators want to compare~     loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel~     (standard drug) in patients undergoing elective coronary intervention.~   "
38845|NCT02548598|"~     This is a cross-sectional, non-interventional study, consisting of three study arms, (1)~     Full Characterization (AIMS-Full), (2) Surgery Arm (AIMS-OR), and (3) Mucus Collection~     (AIMS-M). Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based~     on participant availability). Participants who complete the initial characterization study~     (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which~     focuses mainly on sample collection. Participants who choose not to participate in either~     characterization arm are able to enroll directly into AIMS-M for sample collection only.~   "
38846|NCT02548585|"~     A Phase 1/2, multiple dose study with 4 cohorts of ascending doses designed to evaluate the~     efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes~     Mellitus (T2DM).~   "
38847|NCT02548572|"~     Several studies have shown that TES in RP patients may help to slow the progressive~     deterioration of this degenerative disease. The end point of this clinical trial is to slow~     or stop disease progression with weekly treatment using TES for 1 year.~   "
38848|NCT02548559|"~     This study evaluates the effects of cannabidiol (CBD) for the treatment of anxiety in adults~     certified for medical marijuana. Participants will use a sublingual (under-the-tongue)~     tincture of whole plant derived CBD three times daily for four weeks in addition to their~     normal treatment regimen. Participants' clinical state will be assessed weekly during the~     treatment period. In addition, cognitive function and measures of quality of life, sleep,~     general health, and multimodal neuroimaging will be assessed at baseline and the~     post-treatment final visit.~   "
38849|NCT02548546|"~     The primary aim of this study is to establish the practicality of using two novel imaging~     modalities for the assessment of biomechanical properties of the aorta.~   "
38850|NCT02548533|"~     The purpose of this study is to assess the efficacy of skin anesthesia using fractional~     laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml~     solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine~     25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser~     treatment of acne scars and traumatic scars.~   "
38851|NCT02548520|"~     In this study the investigators wanted to assess vitamin D status and possible consequences~     of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their~     infants, in the community of Aarhus, Denmark.~   "
38852|NCT02548507|"~     Background :~      Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower~     limbs occurring during prolonged periods of rest, typically during the night. They may cause~     severe pain and sleep disturbance, and are particularly common among older adults, though~     they can occur in all decades of life. They are frequently unreported to physicians. To the~     investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but~     in a general population survey carried out in the UK (n=233), the overall prevalence of NLC~     was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those~     who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another~     study performed in older US veterans (n=515) showed that 56% suffered from NLC.~      The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be~     idiopathic, but potential contributing factors include low levels of certain minerals,~     extracellular fluid volume depletion and prolonged sitting or inappropriate leg position~     during sedentary activity.~      Research question :~      What are the prevalence and the main features of NLC in patients consulting primary care~     physicians (PCPs) in Geneva, and how do PCPs treat this affection?~      Primary objective :~      To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main~     features (number, duration, severity and sleep disturbance) and assess how PCPs treat this~     affection.~      Study design :~      Prospective observational study using questionnaire and daily log completed by patients.~   "
38853|NCT02548494|"~     The management goals of diabetic ketoacidosis (DKA) in the pediatric new-onset type 1~     diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and~     correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting~     insulin IV infusion is begun immediately and continued until the acidosis is corrected and~     hyperglycemia normalized. Once the acidosis is corrected, patients are able to be~     transitioned to a subcutaneous insulin regimen.~      The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment~     of DKA has not been extensively studied. While giving glargine during the treatment of DKA~     is becoming more common place, few studies have examined the potential risks and benefits of~     its use. This study will investigate the effects of early administration of glargine during~     DKA in patients with newly diagnosed TIDM.~      The design of this study is a prospective, double-blind study of children ages 2-21 who are~     admitted to the hospital in DKA with a new diagnosis of T1DM. The control group will receive~     all traditional methods of treatment for DKA, including a placebo subcutaneous injection.~     The study group will receive the same treatment, but will be supplemented with a~     subcutaneous glargine injection.~   "
38854|NCT02548481|"~     Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients~     survived with aftereffects, in particular aphasic disorders.~      A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post~     stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed,~     adjusted and a new complete tool (BESTA) had been created in order to evaluate the different~     states of aphasia.~      The goal of this study is the validation and the standardization of this new BESTA tool.~   "
38870|NCT02548260|"~     Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no~     treatment has been shown to be superior. The investigators wish to study the effectiveness~     of syndactyly versus digital splint when comparing joint mobility. The investigators also~     wish to study the effectiveness of finger compression in reducing edema and therefore~     allowing a greater arc of motion.~   "
38855|NCT02548468|"~     This phase I trial studies the side effects and the best dose of donor lymphocyte infusion~     when given together with reduced intensity conditioning regimen before partially matched~     donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or~     Sezary syndrome. Giving chemotherapy and low-dose total-body irradiation followed by~     high-dose cyclophosphamide before a donor peripheral blood stem cell transplant helps stop~     the growth of cells in the bone marrow, including normal blood-forming cells (stem cells)~     and cancer cells. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells (called graft-versus-host disease). Removing the T-cells~     from the donor cells and giving them before transplant may stop this from happening.~     Additionally, giving tacrolimus and mycophenolate mofetil before and after transplant may~     also stop this from happening.~   "
38856|NCT02548455|"~     The primary intent of this study is to assess the safety of the model 1457Q Quartet Left~     Ventricular (LV) lead at 3 months in a patient population indicated for cardiac~     resynchronization therapy.~   "
38857|NCT02548442|"~     Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to~     Diagnose Autism Spectrum Disorder in Early Childhood.~   "
38858|NCT02548416|"~     Atelectasis is common during and after general anaesthesia and a number of interventions~     have been suggested in order to prevent their formation. The use of Positive End Expiratory~     Pressure (PEEP) during general anaesthesia has in recent years been questioned.~      The investigators hypothesize that the use of PEEP as a single intervention improves~     oxygenation and prevents atelectasis as investigated by computed tomography compared to a~     control group with zero PEEP.~   "
38859|NCT02548403|"~     Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal~     visualization during colonoscopy is often limited by residual stool, bubbles, bile,~     intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other~     small lesions.Therefore, intestinal preparation is necessary to remove residual materials~     prior to endoscopy.~      A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution~     commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However,~     practitioners have noted an increased incidence of bubble formation with this preparation~     method.~      To the investigators knowledge, no previous study has assessed colon preparation in patients~     administered simethicone.~      The purpose of this study was to compare the quality of bowel preparation and compliance~     between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an~     antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel~     preparation scale and bubble score, and the compliance of both patients and endoscopists was~     also investigated using a questionnaire.~   "
38860|NCT02548390|"~     This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107~     administered to subjects with advanced solid tumors. The study is designed to explore the~     safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary~     clinical activity of RXDX-107 and to define a recommended Phase 2 dose (RP2D)~   "
38861|NCT02548377|"~     The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the~     risk of complications in patients undergoing resection of head and neck cancer and immediate~     reconstruction with autologous free tissue transfer.~      Remote ischemic preconditioning is a treatment, which is carried out by inducing brief~     episodes of upper arm occlusion using an inflatable tourniquet.~      Blood samples will be taken during the operation and postoperatively to evaluate the effects~     of remote ischemic preconditioning. These blood samples will be analyzed for clotting~     properties and markers of inflammation.~      Furthermore, effects on the blood supply of the transferred tissue flap will be measured by~     infrared thermography.~      Effects on surgical complication rates will be obtained by clinical follow-up and patient~     chart review.~   "
38862|NCT02548364|"~     To study the effect of calcifediol on left ventricular remodeling, mineral metabolism,~     plasma levels of several prognostic biomarkers and on endothelial function after an anterior~     myocardial infarction.~   "
38863|NCT02548351|"~     The primary objectives of this study are to evaluate the effect of Obeticholic Acid~     treatment compared to placebo on 1) histological improvement and 2) liver-related clinical~     outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver~     fibrosis.~   "
38864|NCT02548338|"~     The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical~     treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical~     treatment using regular electric scalpel ; 2) surgical treatment using argon plasma~     coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using~     the weight of the surgical tissues used. Secondary we'll evaluate the immediate post~     operative outcomes, like infection, hematomas and seromas. All these variables will be~     evaluated by a doctor using our standard clinical record and it will be measured using~     reliable parameters, for exemple: if the investigators clinically detect a hematoma then~     we'll perform an ultrasound to take the real extension; if the investigators clinically pick~     an infection we'll measure the extension of the hiperemia; and if the investigators~     clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to~     evaluate and measure (centimeters) the terminal damage caused on the surgical specimens~     (samples) using the microscope.~   "
38865|NCT02548325|"~     The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental.~     Also, describe the stage of the disease, and whether if they are under medical treatment or~     not.~   "
38866|NCT02548312|"~     Financial ties with industry are common among doctors, academics and institutions. This~     trial aims to investigate the influence of different types of industry-linked activities on~     readers' perceptions of clinical reviews. Two clinical reviews have been selected on medical~     topics and study participants (practicing doctors) will be sent one review each. The reviews~     will be identical except for the inclusion of one of four different permutations of~     competing interest statements. Participants will be asked to rate the one review they are~     sent based on the study outcomes (confidence, interest, importance and likeliness to change~     practice). The study focus is on educational articles as these are intended to guide patient~     care and convey the authors' interpretation of selected data.~   "
38871|NCT02548247|"~     Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel~     motor function in subjects with constipation.~   "
38873|NCT02548221|"~     The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly~     understood. Improvement of the heart and lung function may contribute to the dyspnea relief.~     But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a~     non-invasive viewing of the heart, which can quickly assess the heart function through~     real-time images. The investigators performed thoracentesis on patients with large-volume~     pleural effusions, and utilized TTE to access the change of heart and lung function before~     and after this medical procedure.~   "
38874|NCT02548208|"~     The study is a single-center, double blinded, randomized controlled trial aimed to~     investigate the effects of focused extracorporeal shockwave therapy (fESWT) on Delayed Onset~     Muscle Soreness (DOMS) of the non-dominant biceps brachialis muscle in healthy voluntary~     adults.~   "
38875|NCT02548195|"~     To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus~     capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic~     cholangiocarcinoma (ICC) -- a randomized control study.~   "
38876|NCT02548182|"~     The investigators are planning to conduct a pilot RCT of young obese population to evaluate~     the effect of smartcare with or without financial incentives for 12 weeks. Participants will~     be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial~     incentives group.~   "
38877|NCT02548169|"~     The primary objective is to confirm clinical safety and feasibility of combining the~     antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid,~     oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine~     in patients with pancreatic cancer.~      The secondary objectives of this trial are to determine preliminary clinical efficacy based~     on response rates, overall survival and progression free survival compared with historic~     control, and surgical conversion rate as defined as percent of locally advanced~     (unresectable) patients achieving resectability within 6 months of treatment initiation.~     Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune~     activating events post-vaccination and to correlate clinical response with acquired immune~     responses.~   "
38878|NCT02548156|"~     The aim of this study is to assess the impact of formulation differences on fluoride~     retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and~     comparing between treatments the concentrations of fluoride and calcium ions in saliva over~     60 minutes after a single brushing with US marketed fluoridated dentifrices and following a~     dietary acid challenge post 60 minutes of brushing with study treatment.~   "
38879|NCT02548143|"~     The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive~     bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have~     inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who~     are undergoing elective surgical or other invasive procedures. Administration of LR769 will~     be performed just prior to surgery/procedure and will be repeated during and after the~     surgery/procedure to achieve and maintain adequate hemostasis as determined by the~     investigator's judgment.~   "
38880|NCT02548130|"~     The goal of this observational study was to evaluate the impact of the adoption of the MELD~     system to prioritize patients on the waiting list for OLT on survival for 700 consecutive~     liver transplantations. Survival was evaluated on the waiting list, one month, and one year~     after the transplantation. Another goal was to look at blood losses and transfusion~     requirement after the adoption of the MELD score. The hypothesis was the MELD system will~     ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses~     and transfusions could be worse with the MELD system.~   "
38881|NCT02548117|"~     Hypogonadism (low testosterone) is becoming an increasingly recognized problem that affects~     numerous men in the United States. Symptoms may be always feeling tired, lower sex drive,~     and loss of muscle mass. Treatment typically involves testosterone in either injections or a~     topical gel form.~      However, administration of testosterone is not without side effects of its own. Testosterone~     supplementation therapy is known to cause a variety of side effects including high blood~     pressure and high lipids (fats) and an increased proportion of red blood cells. Side effects~     of increased red blood cells can include an increased risk of developing a blood clot.~      The increase in the red blood cells is related to dihydrotestosterone (DHT - a male sex~     hormone) activity. It is normal for the testosterone to become DHT. DHT has various effects~     on the body including growth of the prostate gland, baldness, and others and DHT levels have~     been linked to elevated red blood cell counts in men on testosterone.~      Finasteride is an FDA approved medication used in the treatment of benign prostatic~     hypertrophy (BPH) in men with enlarged prostate to improve symptoms and to reduce the risk~     of the need for surgery. Finasteride may prevent elevations in or reduce elevated red blood~     cell levels in men on testosterone.~   "
38882|NCT02548104|"~     Recently, more distal approach to femoral nerve branches (saphenous) in the adductor canal~     in the medial compartment of the thigh have shown to provide comparable anesthesia and~     analgesia without quadriceps muscle weakness than traditional femoral nerve blocks (FNB)~     after total knee arthroplasty (TKA). Adductor canal block (ACB) has the unique advantage of~     providing localized analgesia to the peripatellar and intra-articular aspects of the knee~     joint without reducing the patient's ability to perform a straight leg raise. However, it~     does not adequately address the incisional pain component on the anterior surface of the~     knee innervated by anterior femoral cutaneous nerve. This pain may be improved by addition~     of the anterior femoral block (AFB). Additionally, the ACB does not provide analgesia to the~     posterior aspect of the knee, which is commonly moderate to severe after surgery. This pain~     may be decreased by addition of the genicular block, also known as the iPACK block~     (interspace between the popliteal artery and the capsule of the knee). There is no study~     that has evaluated the potentially analgesic benefits of the AFB or the iPACK block combined~     with ACB after TKA. Therefore, the investigators designed this randomized, prospective, and~     double-blinded study to assess our hypothesis that the addition of the AFB and/or iPACK~     block to the ACB will improve analgesic effects, decrease pain scores, deceased opioid~     requirement, and as well as facilitate early recovery and improve patient satisfaction with~     pain management in patient after TKA.~   "
38953|NCT02547181|"~     This Study is being done because the investigators would like to know if pain and hand~     function after having a boxer's fracture differs between being treated with supportive~     splinting or without splinting, but with behavioral modifications.~   "
38884|NCT02548078|"~     The purpose of this study is to assess the safety and reactogenicity of a single IM dose of~     the ChAd3 EBO-Z vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years,~     separately Considering the risk of exposure to Ebola and the potential (based on animal~     data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all~     children in the study will receive the investigational ChAd3 EBO-Z vaccine. The children in~     the Group EBO-Z/ MENACWY-TT will receive the investigational ChAd3-EBO-Z vaccine at Day 0 of~     the study, whereas the children in the Group MENACWY-TT/ EBO-Z will receive Nimenrix at Day~     0 (as a control). At Month 6, the children in the Group MENACWY-TT/ EBO-Z will receive the~     investigational ChAd3-EBO-Z vaccine (provided that no safety concerns are raised), whereas~     the children in the Group EBO-Z/ MENACWY-TT will receive Nimenrix..~   "
38885|NCT02548065|"~     The present randomized, controlled double blind trial aims to evaluate the efficacy and~     tolerability of balneotherapy with mineral water named Debole of Vetriolo in 100 patients~     with primary Fibromyalgia Syndrome (FS).~   "
38886|NCT02548052|"~     GSK2981278 is a highly potent and selective inverse agonist of retinoic acid~     receptor-related orphan receptor gamma (ROR gamma) that is under development for topical~     treatment of plaque type psoriasis suitable for topical therapy.~      This is the first study to administer GSK2981278 to subjects with psoriasis. This~     proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a~     range of concentrations of GSK2981278 ointment with repeated topical applications in adult~     subjects with psoriasis. Results of this study will provide first clinical information on~     the drug's safety and efficacy in psoriasis and inform the selection of concentration of~     GSK2981278 ointment to be evaluated in subsequent clinical studies.~      This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled,~     subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test~     fields, for intra-individual treatment comparison. For every subject, the manner of~     assignment of each treatment to a particular test field will be according to a randomization~     scheme. Thus, the test fields within each subject, and not the subjects themselves, will be~     randomized.~      The study will consist of screening, followed by a treatment period of 19 days, and a~     follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the~     treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03%~     weight by weight [w/w], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone~     valerate 0.1% cream. The test fields on which these treatments will be applied will be~     identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded~     evaluator (an investigator or designee) will perform the measurements and assessments~     whereas an unblinded study staff member (not an evaluator) will perform biopsy collection.~   "
38887|NCT02548039|"~     The purpose of this study is to match the genetic component and clinical attributes of~     anovulatory patients with response to clomiphene treatment.~      By improving our understanding on patient-specific clomiphene response will allow~     optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.~   "
38888|NCT02548026|"~     The purpose of this study was to determine the effects of low vs. high eating frequency (EF)~     on biomarkers of health and subjective appetite.~   "
38889|NCT02548013|"~     This study is to compare the maternal and neonatal outcomes in the patients with PPROM who~     are managed at home versus those managed at hospital, half the patients will be managed at~     home and the other half will be managed inpatient.~   "
38890|NCT02548000|"~     This study aims to verify the effects of resistance training on neuromuscular, vascular and~     functional adaptations of elderly diabetics type 2. Half of participants will be the~     intervention group that will perform resistance training, while the other half will be the~     control group that will perform stretching sessions.~   "
38891|NCT02547987|"~     The purpose of this study is to determine whether the combination of docetaxel and~     carboplatin is an effective treatment for patients with triple negative breast cancer.~   "
38892|NCT02547974|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the~     investigational GSK Biologicals' GSK3277511A vaccine in adults~   "
38893|NCT02547961|"~     The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion~     for advanced HER2 positive breast cancer.~   "
38894|NCT02547948|"~     The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T~     Cells infusion for B Cell Lymphoma.~   "
38895|NCT02547935|"~     The purpose of this clinical research study is to determine whether dapagliflozin alone or~     in combination with saxagliptin can decrease albuminuria and improve glycemic control in~     patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned~     to randomize a total of 450 patients (150 patients per treatment arm).~   "
38896|NCT02547922|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of two doses of anifrolumab versus placebo in adult subjects with active~     proliferative lupus nephritis (LN).~   "
38897|NCT02547909|"~     Endometriosis is defined as the presence of endometrial glands and stroma outside of the~     uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is~     mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close~     to the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with~     histology should be done to diagnose endometriosis. Probe-based confocal laser~     endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years,~     providing in-vivo cellular-level imaging, a concept known as optical biopsy. considering~     the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with~     a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might~     be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel~     endometriosis.~   "
38898|NCT02547896|"~     It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its~     association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of~     two third molars. After assessing the research parameters, a comparative data analysis,~     along with the proper application of statistical tests, will provide the basis for an~     evaluation of both efficiency medications used.~   "
38899|NCT02547883|"~     In patients ≥ 75 years, there is no evidence that statins in primary prevention are~     associated with a decreased mortality and recent US recommendations consider statins in~     people only between 40 and 75 years. Moreover, statins are associated with numerous side~     effects impacting quality of life of those people and represent a high cost for the French~     healthcare system.~      The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of~     statin cessation in people ≥ 75 years treated in primary prevention.~   "
38900|NCT02547870|"~     The purpose of this study is to compare the single‐dose pharmacokinetics of rilpivirine~     (RPV) after intramuscular (IM) injection of rilpivirine long‐acting parenteral formulation~     (RPV‐LA) and 'aged' RPV‐LA, in healthy adult participants.~   "
38903|NCT02547831|"~     This is a prospective, multicenter observational study under the umbrella of the ISG~     (Italian Sarcoma Group) evaluating local progression-free survival at 3 years of patients~     affected by extra-abdominal primary fibromatosis managed with front-line conservative~     approach and treated only in case of demonstrated progressive disease.~      All patients included will be placed on wait and see approach and then shifted to treatment~     in case of documented radiological progressive disease.~      For patient primarily evaluated for suspected desmoid tumor, a core-needle biopsy~     (eventually under CT/ultrasound guide) will be obtained for histological diagnosis and~     mutational analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or~     surgical procedure has done elsewhere, samples will be requested for histological~     confirmation and mutational analysis (centralization at the investigators Institution).~      In case of progression at 3 months, defined as tumor growth documented radiologically (by~     contrast enhanced MRI) by Response Evaluation Criteria in Solid Tumors (RECIST),~     administered treatments will be proposed and then registered in the clinical database.The~     choice of the treatment and eventually the possibility of continuation of  surveillance~     only will be at the discretion of Institution's Multidisciplinary Sarcoma Committee or as~     part of clinical trials with the consent of patient.~   "
38904|NCT02547818|"~     This is a global Phase III, randomized, double-blinded, placebo-controlled study for~     subjects with evidence of early AD. The protocol is designed to determine whether ALZT-OP1~     combination treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive~     and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).~   "
38905|NCT02547805|"~     Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for~     reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney~     stones.~   "
38906|NCT02547792|"~     This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this~     study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent~     seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27~     subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects~     (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be~     enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and~     immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated~     through 1 year post vaccination.~   "
38907|NCT02547779|"~     The administration of intravenous fluids is ubiquitous in the care of the critically ill.~     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte~     compositions including a range chloride concentrations. Recent studies have associated~     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and~     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased~     mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be~     a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from~     the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The~     primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after~     enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal~     dysfunction at discharge).~   "
38908|NCT02547766|"~     Heart failure remains a major cause of morbidity and mortality. Many patients with heart~     failure receive support from a left ventricular assist device (LVAD) at some point in the~     course of their disease. Some of these LVAD patients experience a durable recovery after~     ventricular unloading with an LVAD, which may be associated with inhibition of inflammatory~     cytokines. This small pilot study aims to determine the biologic and clinical efficacy of an~     interleukin-1 receptor antagonist (Anakinra) at inducing myocardial recovery in patients~     supported with left ventricular assist devices.~   "
38909|NCT02547753|"~     The literature is rich in studies that explore the type and frequency of oral abnormalities~     in transplanted recipients, but it is scarce in studies that provide scientific evidence on~     the risk of complications after invasive interventions on those patients. Within this~     context, the aim of our study is to evaluate the post-exodontic socket repair in kidney~     transplant recipients compared to a control group and see if some indicators in the~     population of transplanted people (complete blood count, cluster of differentiation 4 (CD4+)~     level, serum concentration of immunosuppressive drugs) can help to provide for the host~     response face a invasive procedures. Therefore, 30 kidney transplant recipients over six~     months and 30 healthy non immunosuppressed adults will be submitted to a maximum of 3 simple~     extractions, always by the same surgeon. Laboratory tests will be evaluated preoperatively~     and include: blood count and coagulation - for both groups - and urea, creatinine, CD4+ and~     cluster of differentiation 8 (CD8+) lymphocytes T and serum levels of immunosuppressive drug~     - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7,~     21, 30 and 60 days. The presence, or absence, of post-exodontic complication and delay, or~     not, of socket repair will be the results of interest in this study and will be compared~     between the groups. The data will be evaluated by ANOVA, chi-square. Logistic regression~     analysis will be used to evaluate the influence of modifying factors such as smoking and~     presence of diabetes.~   "
38910|NCT02547740|"~     Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a~     new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is~     getting worse. There is scientific evidence that the macula, the central part of the retina,~     can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very~     prevalent and is often missed using conventional clinical tests.~      Relatively little is known about progression of early glaucoma damage and its effects on the~     macula. This project investigates the nature of progressive damage to the macula and~     proposes new methods to improve accuracy to detect clinically significant progression.The~     study will evaluate the nature of damage to the macula's structures through OCT imaging and~     eye function via visual field tests.~   "
38911|NCT02547727|"~     A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever~     received primary rabies vaccination could improve their immune response to this kind of~     vaccine.~   "
38912|NCT02547714|"~     The purpose of this study is to assess the efficacy and safety of secukinumab at Week 16~     based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response~     to cyclosporine A.~   "
38914|NCT02547688|"~     Preliminary data show that high flow nasal air has been shown to reduce promote heat~     exchange due to evaporation of nasal mucus by the air flow resulting in heat loss. It is~     unclear whether unidirectional nasal airflow is well tolerated in healthy individuals. The~     central hypothesis of this proposal is that dry high flow nasal air will be sufficiently~     tolerated in healthy adults.~   "
38915|NCT02547675|"~     To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC~     who have been treated previously with EGFR directed therapy and have evidence of a T790M~     mutation (T790M+).~   "
38916|NCT02547662|"~     This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work~     in treating patients with previously treated multiple myeloma or plasma cell leukemia.~     Biological therapies, such as pomalidomide and dexamethasone, use substances made from~     living organisms that may stimulate or suppress the immune system in different ways and stop~     cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and~     dexamethasone together may be more effective in treating multiple myeloma.~   "
38917|NCT02547649|"~     This study is designed to assess the effect of two different formulations of pneumococcal~     polysaccharide vaccine on safety and immunogenicity of V114 in healthy adults 50 years of~     age and older.~   "
38918|NCT02547636|"~     This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.~   "
38919|NCT02547623|"~     The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40~     years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion~     criteria will be randomized to 1 of 2 treatment groups~        -  A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone,~          equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;~        -  Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times~          daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp~          biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and~          specular microscopy endothelial cell count.~   "
38920|NCT02547610|"~     In this prospective study, we will recruit newly diagnosed esophageal cancer patients and~     perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be~     added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.~   "
38921|NCT02547597|"~     There are few data regarding anti-anginal effects between beta-blockers with and without~     vasodilating property. Beta-blocker without vasodilating property is generally known to have~     unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared~     carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina~     pectoris.~   "
38922|NCT02547584|"~     This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in~     female patients with paroxysmal and persistent atrial fibrillation (AF).~   "
38923|NCT02547571|"~     The purpose of this study is to compare diet, type of bowel preparation and time of~     colonoscopy to determine if one method is better than the other and, if they are the same,~     identify the one which is the most convenient for the patients.~   "
38924|NCT02547558|"~     To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled~     indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011~     groups.~      Measurements on a single day before and after 60 and 120 minutes of indacaterol will include~     arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in~     exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated.~     Cardiac output will be directly measured by bio-impedance.~   "
38925|NCT02547545|"~     This is a cohort study. This study is to develop a predictive model of the side effects~     after chemotherapy, exploreing the potential risk factors of the side effects such as~     myelosuppression and chemotherapy realted vomit after the chemotherapy, so that it could~     help to alleviate patients' fear and anxiety about the side effects and the toxicity of~     chemotherapy. The potential risk factors were measured at baseline.~   "
38926|NCT02547532|"~     In the context of the increasing evidence of the pathogenetic role of microbiome in COPD,~     our aim is to determine the total and specific bacterial and viral load in sputa from~     patients with COPD due to AATD and to correlate these findings with cellular, biochemical~     and immunological characteristics of sputa. These quantitative data obtained from sputum~     will be analyzed in the context of the clinical and physiological parameters of the~     patients.~   "
38927|NCT02547519|"~     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta~     cells within the pancreatic islets of Langerhans. This process is identified by circulating~     islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological~     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or~     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T~     cells. Immunological tolerance can be achieved by administration of antigen under~     appropriate conditions. Administration of oral insulin in islet autoantibody-negative~     children who are genetically predisposed for T1D offers the potential for inducing~     immunological tolerance to beta cells and thereby protect against the development of islet~     autoimmunity and T1D.~   "
38928|NCT02547506|"~     The central goal of the proposed study is to generate essential pilot data necessary to~     support an established line of research leading to future extramural grant submissions. The~     aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and~     gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD)~     who participate in boxing on a regular basis, (2) individuals with PD who participate in~     exercise other than boxing on a regular basis and (3) healthy controls of the same age who~     exercise on a regular basis and 2) to examine the relationship between CRF and motor~     symptoms of PD (bradykinesia, tremor and postural instability). Forty-five participants (15~     for each group) who participate in exercise on a regular basis (at least 120 minutes of~     exercise per week for the past 3 months) will be recruited for this cross-sectional study.~     In a single testing session, participants will perform the following tests: (1) clinical~     performance measures and (2) a CRF assessment. A one-way ANOVA with appropriate post hoc~     tests will be used to examine differences in dependent variables across the three exercise~     groups. Relationships between CRF and clinical performance measures will be evaluated with~     Pearson's correlation coefficients.~   "
38929|NCT02547493|"~     Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more~     efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral~     response) in RA patients treated with abatacept, biotherapy targeting T-cells? The~     investigator propose to conduct a prospective, multicenter (11 centers), randomized,~     open-label study.~      The patients are going to be randomized in 2 groups: patients of the first group will be~     vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®) whereas patients of the~     second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).~   "
38930|NCT02547480|"~     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and~     efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver~     predominant mCRC by chemoembolization.~   "
38931|NCT02547467|"~     The aim of this study is to assess the causes of death in patients with septic shock in~     French intensive care units. It is an epidemiologic and descriptive study .~   "
38932|NCT02547454|"~     This observational trial will examine the efficacy and safety of Mircera for renal anemia in~     participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by~     treating physician and followed for approximately 36 months.~   "
38933|NCT02547441|"~     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel~     compared to vehicle gel in subjects with severe papulopustular rosacea.~   "
38934|NCT02547428|"~     This is a Phase IIb, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover~     study to evaluate safety, efficacy, and duration of efficacy of CTN SR BID target total~     daily dose (TDD) 400 mg compared with placebo in adults with ADHD.~   "
38935|NCT02547415|"~     Medically unexplained chronic pain - without identifiable somatic origin - is yet an~     insufficiently known and explored field in children and adolescents by international~     clinical works. This research aims to characterize somatic, psychological,~     psychopathological and environmental (particularly attachment styles and family functioning)~     processes trough an observational study with three pain management centers.~      The study concerns children and adolescents from 7 to 17 years old, suffering of medically~     unexplained chronic pain and their parents who are referred to a pain center. It is composed~     of a somatic, psychological and family functioning assessment on the one hand and~     psychopathological and attachment evaluation on the other hand.~   "
38936|NCT02547402|"~     This is an exploratory study in a small, well controlled group of healthy subjects to~     explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and~     ezetimibe).~   "
38937|NCT02547389|"~     Improving medical compliance and health-related quality of life (HRQoL) among people with~     epilepsy (PWE) has become the focus of various treatment programs and behavioral~     interventions which continue to be challenging to both patients and health care~     professionals.~      In order to design an effective intervention on the management of epilepsy, the drug~     management of epilepsy by community health workers was evaluated.~   "
38938|NCT02547376|"~     Soft tissue sarcomas (STSs) are a rare group of cancers that can arise in any 'soft' tissue~     but commonly involve muscles, fat and nerves. Even following surgery and radiotherapy over~     50% of tumours will recur or spread and at present, there is no reliable test that allows~     doctors to predict in which patients this will occur.~      DNA that is not inside cells (cell-free or cfDNA) is present in very small quantities~     circulating in blood. In cancer patients some of this cfDNA comes from cancer cells.~     Analysis of cancer-derived cfDNA in patients with other cancers has shown that the quantity~     and characteristics of cfDNA changes with stage of disease and treatment. The researchers~     plan to investigate the abundance and persistence of cancer-derived cfDNA in STS patients at~     various stages of disease to investigate the potential role of these characteristics as~     biomarkers.~      Selection of the genetic characters to be tracked in the patients' cfDNA is an important~     consideration. An established hallmark of a cancer cell is the ability to undergo an~     unlimited number of cell divisions. In normal human cells protective structures on the ends~     of chromosomes called telomeres provide a mechanism to limit the number of times a healthy~     cell can divide. This limitation has to be overcome in cancer cells for a tumour to form.~     This occurs by the activation of one of two telomere maintenance mechanisms (TMM) - either~     an enzyme called Telomerase or a mechanism known as Alternative Lengthening of Telomeres~     (ALT). In many sarcomas the activation of either TMM is associated with genetic changes~     (mutations) in a small number of genes. As these mutations are not present in normal cells~     but mark an essential feature of cancer cells (and their capacity for unlimited cell~     division) they are likely to be reliable markers of the presence of STS cells.~      The investigators plan to develop sensitive, quantitative assays to detect TMM associated~     mutations in tumour derived cfDNA in the blood of patients with STSs, and track these~     mutations overtime. They will establish the amount of cancer-derived cfDNA in STS patients~     at the time of surgery, and persistence of this cfDNA during follow up visits following~     tumour resection and in the events of local tumour recurrence or spread (metastatic~     disease). Once these basic parameters are established analysis will be broadened to include~     other genes that are commonly mutated in STSs with a view of identifying other genetic~     characteristics that may also aid identification of patients at high risk of recurrence or~     spread. In summary all of the assays described above should facilitate better monitoring of~     patients with STS, and allow earlier treatment if STS recurs following surgery.~   "
38939|NCT02547363|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive~     days as field treatment.~   "
38940|NCT02547350|"~     The purpose of this study is to evaluate the efficacy of prophylactic intravesical~     chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder~     recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).~   "
38941|NCT02547337|"~     Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs~     clarification in order to reach feasible means of preventing the disease. This study aims in~     defining the differences in pancreatic and intestinal blood flow between subjects with and~     without type 1 diabetes and validating the methodology to achieve this. Earlier animal~     studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim~     of this study is to test and validate a method for the assessment of islet perfusion in~     humans using molecular imaging. The investigators hypothesize that glucose-stimulated~     pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this~     increase is mostly suppressed in subjects with type 1 diabetes.~      Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to~     study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular~     perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic~     resonance imaging (DWI) has also been applied as a complimentary method for the assessment~     to quantitate changes in pancreatic blood flow.~      In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two~     separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and~     combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous~     glucose infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the~     same time schedule and with intravenous glucose stimulation.~   "
49412|NCT02410356|"~     This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in~     adults with GHD who have previously been treated with rhGH.~   "
38943|NCT02547311|"~     Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles~     with their diabetes management resulting in worsening diabetes health and increased~     complications. This population's declining well-being occurs during a time when they should~     be at their healthiest and enjoying multiple exciting life transitions. Their worsening~     diabetes management is complicated by the fact they are also learning how to become more~     independent from their family in preparation for eventually leaving home. Furthermore, the~     number of people under 20 years of age diagnosed with T1D has increased dramatically over~     the past 10 years giving rise to increased concern about providing care to this population.~      The Team Clinic Intervention is an innovative clinical care approach to address the medical~     and developmental needs of adolescents with T1D and their families. A group medical~     appointment format will be used for routine diabetes clinic visits in middle school and high~     school adolescents with T1D. Parents of these patients will be participating in their own~     group during these clinic visits. The Team Clinic model incorporates developmentally~     tailored peer support and novel learning tools, (e.g. games, physical activity, and/or~     interaction through Internet resources, e.g. blogs, forums) into the shared medical~     appointment design.~      The goal of Team Clinic Intervention is to improve medical and psychological outcomes in~     adolescents with T1D and their parents. The study will investigate, in a randomized~     controlled trial, the efficacy of a novel clinical care model that addresses the unique~     developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic~     format streamlines clinical care delivery to this often-challenging patient population~     without placing additional burden on youth, families, or clinics because the intervention~     will be completed during routine diabetes care visits. Moreover, the Team Clinic approach~     maximizes the benefits of peer support by delivering care in a group format to address the~     sense of isolation that teens and families coping with chronic illness often feel.~      If successful, the Team Clinic Intervention will not only positively impact adolescents with~     T1D and their families, but it could be used as a model of care for other adolescents with~     chronic medical conditions struggling to remain involved and invested in their medical care.~     Team Clinics may be one approach to successfully engaging adolescents in their diabetes care~     prior to their transition away from home, which will help them remain invested and active in~     their medical care through adolescence and young adulthood.~   "
38944|NCT02547298|"~     Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic~     procedure involving cystoscopy (a lighted scope is used to look inside the bladder) under~     anesthesia will be approached to participate in the study. Once prospective study subjects~     are consented, they will be requested to complete the study questionnaires.~      At the time of the procedure, during the cystoscopy, patients will undergo hydrodistension~     (stretching the bladder with fluid). Photographic images of the bladder will be collected,~     to be later analyzed by examiners. Patients who have positive findings for interstitial~     cystitis during cystoscopy with hydrodistension, will be notified of the findings after the~     procedure.~      They will be asked to fill out an additional, previously completed questionnaire at the time~     of a follow-up visit, during a phone interview or responding to the questionnaire via a~     secure web site. These patients will be treated for interstitial cystitis by their primary~     providers as clinically indicated.~   "
38945|NCT02547285|"~     The proportion of people aged 60 and over in the French population has increased from 18% in~     1970 to over 22% in 2010.~      One major problem in the elderly is falling. About half of these falls cause a minor injury~     and between 5% and 25% will cause a more serious injury such as a fracture or a sprain~     (Alexander et al., 1992; Nevitt et al., 1991).~      It therefore seems essential to study the locomotion of seniors to limit the maximum risk of~     falling into a public health measure.~      Two factors may be involved:~        1. The first corresponds to factors related to natural aging topics~        2. The second is the environment that is a real problem for seniors (Rolling showers,~          presence of works ....) And especially the port of inappropriate footwear.~      Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this~     parameter that will be highlighted in our study.~   "
38946|NCT02547272|"~     Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A~     methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus~     bacteremia with are due to the strain isolated in the nasal level. However, as part of a~     study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic~     orthopedic devices have been linked to nasal carriage . Outside of exogenous infections,~     intestinal colonization with S. aureus could be an alternative source of endogenous~     infections with the waning of orthopedic surgery. In the general population, considering~     that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in~     the intestine However the proportion of exclusive intestinal porting is not well known .~      This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It~     will better clarify the relationship between nasal and rectal ports and the risk of~     developing an infection.~   "
38947|NCT02547259|"~     Currently there is uncertainty on how schizophrenic patients feel pain. Pain has several~     components including cognitive behavior which allow humans to perceive it as a negative~     emotion. It is difficult to say precisely what are the differences in cognitive processing~     between the emotional component of pain and painless another negative emotion (eg fear).~     However, pain and negative emotion have some neural networks together and there are many~     common ways between emotional processing (pain or negative) and storing information (limbic~     system).~   "
38948|NCT02547246|"~     Bulimic patients suffering from binge eating or craving a pressing need to eat, with a~     sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may~     be considered appropriately by using paradigms developed in the framework of embodied~     cognition theories.~      In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious)~     for food in these patients, as measured by reaction time.~      Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated~     transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS~     to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving~     among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia~     to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying~     mechanisms have not yet been explored.~   "
38949|NCT02547233|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days~     as field treatment.~   "
38950|NCT02547220|"~     To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated~     rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the~     proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months~     after treatment initiation.~   "
38951|NCT02547207|"~     The purpose of this study is to characterize left ventricular acute hemodynamic and~     electrical responses during cardiac resynchronization therapy (CRT) with different~     Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation~     patterns and hemodynamic measurements during these pacing settings.~   "
38952|NCT02547194|"~     The health-related quality of life questionnaire EQ-5D has been collected in connection~     with several interventional and observational studies where the no-touch vein harvesting~     technique in CABG has been used. The results of the questionnaires will be compiled and~     reported in this study.~   "
38954|NCT02547168|"~     Lung resections for pulmonary malignancies offer the best chance of survival for patients,~     but these procedures carry a significant burden of post-operative morbidity and mortality.~     Patients are particularly at high risk for post-operative atrial fibrillation (a condition~     involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk~     of stroke - a blockage in a major blood vessel in the brain, which can potentially result in~     a disability or even death. The objective of this study is to establish the feasibility of~     using ambulatory heart rate monitoring to determine the total incidence of atrial~     fibrillation in the peri-operative period before and after anatomic lung resection for~     malignancies. The study will also investigate the correlation between atrial fibrillation~     and rates of stroke and other adverse events, as well as serve to identify the patients that~     are at a higher risk of developing atrial fibrillation.~   "
38955|NCT02547155|"~     The purpose of the study is to compare the risk of being unable to urinate shortly after~     surgery, also called acute post-operative urinary retention (POUR) between spinal and~     general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary~     incontinence surgery.~   "
38956|NCT02547142|"~     Palliative care physicians and nurses are trained to help reduce suffering and improve~     quality of life in patients under their care. Their services also include other components~     such as referral to dietitians, social workers and community resources, to assist patients~     in their homes. In addition to this, they may also administer interventions to make patients~     more comfortable, assisting them and their families in making important decisions and~     providing support, during that time.~      At present, palliative care is provided to esophageal cancer patients on an as-needed basis,~     through the referral of a heath care professional or the patient's request. This study aims~     to assess the impact of the integration of early palliative care combined with appropriate~     medical care in the metastatic esophageal cancer population, so that patients can benefit~     from these services at an earlier stage. It is hoped that this will improve quality of life,~     symptom management, depression and anxiety, as well as survival.~   "
38957|NCT02547129|"~     What is the difference in the outcomes of patients treated with an articulating antibiotic~     spacer versus a static articulating spacer in the setting of two stage exchange for infected~     total knee arthroplasty?~   "
38958|NCT02547116|"~     Methicillin-susceptible (MSSA) and Methicillin-resistant (MRSA) Staphylococcus aureus (SA)~     are two of the most important infectious pathogens in CF, with 69% of CF patients having~     lung infection with MSSA or MRSA in the last year. Wolter and co-workers recently~     demonstrated that a specific morphologic subtype of MSSA and MRSA, small-colony variant~     Staph aureus (SCV-SA), is associated with greater decline in lung function and worse~     clinical outcomes. SCV-SA is already recognized for its ability to contribute to persistent~     infection, likely due to SCV-SA's ability for intracellular growth, as well as its increased~     antibiotic resistance compared to normal-colony SA. To investigate the epidemiology and~     clinical significance of SCV-SA in CF, and explore the hypothesis that SCV-SA may require~     unique antibiotic treatment strategies to optimize clinical response, the investigators will~     perform the following:~        1. Characterize the epidemiology of SCV-SA infection in both an adult and pediatric CF~          population and investigate the clinical significance of SCV-SA infection in CF by~          comparing clinical characteristics and outcomes of CF patients with SCV-SA compared to~          those with to normal-colony MSSA/MRSA.~        2. Characterize the unique microbiologic characteristics of SCV-SA infection in CF by~          evaluating antibiotic susceptibility profiles and molecular characteristics of SCV-SA~          in a two large CF patient populations.~        3. Perform a 16-patient pilot study of a novel treatment for SCV-SA infection in CF,~          utilizing low dose rifampin in combination with standard anti-SA antibiotics.~      These investigations will delineate the role of SCV-SA as a pathogen in CF and provide~     guidance to optimize treatment strategies of MSSA/MRSA CF lung infection.~   "
38959|NCT02547103|"~     This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine~     gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care~     (normal saline) with aseptic technique in prevention of PD-related infection. It is a pilot~     study, double-blind, stratified randomized controlled trial. Participants will be randomized~     to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be~     followed at 1,3,6,9, and 12 months or until PD-related infection, catheter removal, or~     death. The primary outcome is PD-related infection. Secondary outcomes are safety, adverse~     events related to treatments such as skin irritation, rash etc. Other outcomes are~     hospitalization due to PD-related infection, technical failure,change of modal of dialysis,~     adherence to medication, death due to PD-related infection. Costs include providers and~     patients expenses. Utility is assessed using the EuroQol (EQ), five-dimensional (5D),~     five-level (5L) version. The results of this study are anticipate nephrologists and health~     care professional involving to PD in decision making for a plan to prevent PD-related~     infection. In addition, the results will lead to clinical guideline development a prevention~     of PD-related infection.~   "
38960|NCT02547090|"~     Background:~      Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of~     complications and mortality. Complication rates have been reported as high as 45%, and~     infection rates typically reported at 15%. Efforts to improve efficiency by reducing~     operative time and blood loss could decrease these risks. The purpose of this study is to~     investigate the impact of utilizing two attending surgeons on blood loss, operative time,~     and complications in this population.~      Methods:~      This is a prospective, matched cohort analysis with a consecutive series of patients with CP~     who underwent PSF, with two attending surgeons, in 2012. These are matched with a control~     group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident,~     PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests~     (significance set a p<0.05).~   "
38961|NCT02547077|"~     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during~     repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure~     with 5-0 fast absorbing gut.~   "
38962|NCT02547064|"~     The GlideScope® videolaryngoscope usually visualize glottis better than the conventional~     laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of~     endotracheal tube, however, is challenging.~      The goal of this study was to determine which of two stylet (10cm, 60° vs 8cm, 90°) was~     better, as determined by time to intubation.~   "
38963|NCT02547051|"~     The purpose of this study is to see whether participants with persistent developmental~     stuttering (PDS) who report fluctuational severity on a day to day basis of can achieve a~     more normalized fluency of speech by identifying dietary allergen responses and subsequently~     eliminating these dietary triggers from their daily consumption.~   "
38964|NCT02547038|"~     Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy~     remained unanswered.~   "
38965|NCT02547025|"~     In this study, the investigators develop a personalized treatment according to~     culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat~     refractory H pylori infection.~   "
38966|NCT02547012|"~     From the profiles of antibiotic susceptibility data following eradication therapy,~     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in~     the rescue treatment.~   "
38967|NCT02546999|"~     In Norway, about 60% of all children with cerebral palsy (CP) are being treated with~     botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread~     use of the drug, the evidence for a positive effect on walking is insufficient. Moreover,~     large variation in effect is seen by clinicians. The main objective of the present study is~     to investigate whether injections with BoNT-A in the calf muscles make walking easier in~     children with spastic CP within 6 months, reflected by reduced energy cost during walking.~   "
38968|NCT02546986|"~     The purpose of this study is to determine whether the combination therapy of CC-486 (oral~     azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab~     alone in subjects with previously treated locally advanced or metastatic non-small cell lung~     cancer.~   "
38969|NCT02546973|"~     A national study of a three year cohort consisting of all patients diagnosed with anal~     cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry,~     Patient registry and Cause of Death Registry all within the Swedish Board of Health and~     Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates~     will be requested including.~      Patient documentation from the concerned hospitals will be collected and data on the details~     of the treatment collected retrospectively in a standardised fashion using a clinical record~     form.~      Comorbidity will be calculated using data from the Patient Registry using all main and~     co-diagnoses 2 years prior and then at least two years after treatment cessation.~      Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6~     years after index treatment.~   "
38970|NCT02546960|"~     The purpose of this study is to evaluate the safety, tolerability of different doses of~     JNJ-63871860 (ExPEC4V) in participants greater than or equal to (>=)18 years of age and to~     evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked~     immunosorbent assay (ELISA).~   "
38971|NCT02546947|"~     Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective~     mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a~     prospective multicenter study demonstrates that short-term infusion of neuromuscular~     blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which~     NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a~     beneficial effect is still debated. In hypoxemic ventilated patients, continuous~     cisatracurium infusion with an objective of no response at orbicularis oculi to~     train-of-four (TOF) stimulation and an objective of two responses had similar effects on~     respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an~     initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on~     previous results of studies with patients monitored for paralysis. In ICU, a variety of~     factors can affect the pharmacokinetics and pharmacodynamics of muscle relaxants: liver~     and/or kidney failure; sepsis; hypothermia; fluid and electrolyte imbalances; disorders of~     acid-base balance; as well as potential drug interactions (for example, aminoglycosides,~     steroids). In a recent study, none of ICU patients (0/17) versus 15/17 patients undergoing~     anesthesia for elective surgery were completely paralyzed after an initial standard dose for~     intubation of 0.15 mg.kg-1 (dieye, 2014). Atracurium and its stereoisomer cisatracurium are~     non-depolarizing neuromuscular blocking drugs, used in anaesthesia and intensive care. Their~     elimination may be from both plasma and tissues (Hofmann elimination). Atracurium was poorly~     studied in ICU.~   "
38972|NCT02546934|"~     ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)~   "
38973|NCT02546921|"~     This first in human study of the new therapeutic antibody MOv18 IgE in patients with~     advanced cancer seeks to demonstrate the potential for the use of this IgE antibody as an~     example of the use of the IgE class of antibodies for the treatment of cancer.~   "
38974|NCT02546908|"~     The purpose of this study is to document prostate cancer (PC) management including~     diagnosis, prognosis, treatment, and care in real-world practice.~   "
38975|NCT02546895|"~     Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual~     incidence of Head and neck cancers is more than 650,000 the patients each year. Head and~     neck cancers are associated with smoking, alcohol consumption, human papilloma virus (type~     16 and 18) and previous exposure to radiation.~      So far, most of clinical and research data about head and neck cancers, such as the~     etiology, pathogenesis, prognosis factors and associated factors, treatment outcomes, are~     from Western countries. However, due to various environmental factors, for example race,~     genetics, geographical factors, general hygiene and health care system differences, the~     possibility of differences of disease characteristics between Western and Asian people~     should be considered.~      For several decades, there have been many studies about treatment modalities (surgery,~     chemotherapy, and radiation therapy), complications and side effects for head and neck~     cancers in the West. Many institutions tried to improve the survival rate and resolve the~     toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However~     there has been little information about the characteristics of head and neck cancers,~     effectiveness of treatment (survival rate, recurrence, and complication rate), and~     prognosis, particularly in Korean as well as in Asian patients.~      Therefore it is necessary to evaluate and analyze the features of head and neck cancers such~     as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site~     specific cohort (South Korea) separately. It could be helpful to improve the treatment~     outcomes of head and neck cancers overall, to design race or site specific treatments for~     head and neck cancers, and to develop management strategy common in Asia as well as the~     West.~      The purpose of this study is~        1. To establish the prospective tumor registry about patient's information,~          treatment-related morbidities, treatment outcomes and quality of life, in addition to~          the prospective collection of patient samples (blood and tumor tissues).~        2. To establish the predictive model for treatment outcomes and treatment-related~          morbidities.~        3. To develop the biomarkers as predictive and/or prognostic factors.~   "
38976|NCT02546882|"~     The purpose of this study is to observe whether the transplantation of autologous stromal~     vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture~     and contracture of skin grafting.~   "
49413|NCT02410343|"~     The primary objective of this study is to determine the efficacy of 6 months of treatment~     with TV-1106 compared with placebo on body fat composition.~   "
38977|NCT02546869|"~     This multi-center, single-arm study is designed to evaluate clinical experience of~     participants (or caregivers) administering lebrikizumab at home in participants with asthma.~     Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4~     weeks (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment,~     all participants will complete a 12 week safety follow up. All participants will get~     training for the administartion of lebrikizumab using the device.~   "
38978|NCT02546856|"~     Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which~     are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme~     Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor~     Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless,~     dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration~     of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety.~     Objective: To compare doses achieved by patients of BB, ACEI, ARA II and ARM in 4 months ( %~     relative to target doses) in the intervention group (HF nurse) and in the control group (~     cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart~     Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and~     mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New~     (de novo) HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17~     Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and,~     driven by protocol, the HF nurse implements the up-titration. In the control group doses are~     decided by the cardiologist clinical support and education being provided by nurses.~     Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF),~     NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP),~     6min. walking test, Creatinine/Glomedular Filtration Rate (GFR), Potassium (K), haemoglobin,~     Blood Preassure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour~     Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality~     of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be~     provided on the effectiveness of this healthcare management, that could be economically~     evaluated in future studies. A qualitative study also will be undertaken to explore barriers~     and facilitators to implementation~   "
38979|NCT02546843|"~     This randomized study prospectively evaluates our experience with administration of~     cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various~     depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy~     with low-pressure capnoperitoneum.~   "
38980|NCT02546830|"~     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver~     automatically oxygen in the post anesthesia care unit in a patient population admitted for~     major abdominal and thoracic surgery.~      The investigators' hypothesis is that FreeO2 system will provide a better control of the~     oxygen saturation and reduce postoperative hypoxaemia.~   "
38981|NCT02546817|"~     To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism~     (VTE) patients and patient characteristics that are associated with bleeding among patients~     taking Eliquis. To identify factors that might be associated with the safety and~     effectiveness profile in Korean VTE patients.~   "
38982|NCT02546804|"~     Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The~     Periodontal Disease is a multifactorial but the dental plaque is considered as main~     etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in~     between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum~     infection and tooth loss. Though, many scientific periodontal procedures are available to~     get the treatment but because of lack of man power and poor socioeconomic condition it is~     not possible for every group of population in our India.~   "
38983|NCT02546791|"~     This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of~     chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will~     include 100 patients treated in different public centers in the Mexican Republic.~   "
38984|NCT02546778|"~     Nowadays increasingly quest for improved physical appearance, gradually developing the~     medicine of beauty, where the radio fits as an additional tool in helping some aging~     processes and maintenance of body shape. The aim of this study was to evaluate and compare~     the changes in the thickness of adipose tissue and blood levels of some biochemical markers~     of sedentary and active women who underwent radio frequency technique via ultrasound imaging~     and laboratory tests. Seven (7) sessions were held, each lasting 20 minutes each, 22~     volunteers allocated into two groups, sedentary and physically active. Measures ultrasound~     image were collected at baseline, pre-treatment and post-treatment period period and serum~     biochemical parameters (lipid profile, liver and kidney) for the pre-treatment and~     post-treatment.~   "
38985|NCT02546765|"~     Investigators will assess the incidence and duration of postoperative delirium in patients~     ≥60 years old undergoing Coronary Artery Bypass Grafting (CABG), with/without valve surgery~     (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia.~     Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or~     standard postoperative management using IV propofol with morphine or hydromorphine. The~     Confusion Assessment Method (CAM) will be used to assess delirium in these patients.~     Investigators also seek to compare overall postoperative analgesic requirements in patients~     with or without IV acetaminophen. Investigators will finally assess postoperative cognition~     in post-surgical patients up to one year post-discharge using a cognitive assessment scale.~   "
38986|NCT02546752|"~     This primary goal of this study is to assess whether patient whose parents watch a~     standardized digital video using the integrated digital approach during a routine office~     visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to~     those not completing the program. The study team anticipates eligible patients in the~     intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses)~     than patients in the usual care comparison clinics.~      Additionally, the study team is interested in determining the impact of the integrated~     system on clinical workflow by measuring the number of minutes of each patient office visit~     when using the system compared to the number of minutes of each visit in offices where the~     system is not used.~      Although this is a descriptive/exploratory aim, our expectation is that the THEO system will~     have minimal impact on patient flow.~   "
38987|NCT02546739|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed~     CD19+ haematological malignancies.~   "
39078|NCT02545556|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery~     for liver cancer.~   "
38988|NCT02546726|"~     This study is intended for inactive, middle-aged adults with untreated pre-hypertension who~     live in the Urbana-Champaign area, who are interested in a comprehensive program designed to~     enhance physical activity & reduce blood pressure. All participants will be asked to engage~     in a program developed in accordance with American Heart Association's recommendations.~     Specifically, the program will encourage and support lifestyle behavior changes such as~     quitting smoking, eating heart-healthy food, and reducing excessive alcohol, in addition to~     weekly exercise. The exercise program will involve a 14-week aerobic training program (3~     weekly sessions, scheduled at study participants' convenience), and 2 pre- and~     2-post-testing sessions.~   "
38989|NCT02546713|"~     The aim of this study is to evaluate the effect of abutment macro-design on soft and hard~     tissue responses. This trial is designed as a randomized controlled clinical study in which~     two groups of fourteen partially edentulous patients will have as part of their treatment~     one implant placed in the maxillary premolar region.~   "
38990|NCT02546700|"~     Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of~     lebrikizumab in participants with COPD and a history of exacerbations who are treated with~     inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication.~     This study will be conducted to assess the safety, efficacy, and patient-reported outcome~     (PRO) measures.~   "
38991|NCT02546687|"~     Esophageal resection becomes a routine surgical procedure in many medical centers. Usually~     reconstruction after esophagectomy is achieved by gastric pull-up with cervical or~     intrathoracic anastomosis. The only blood supply for this gastric tube is by right~     gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for~     future anastomotic leaks or strictures.~      The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate)~     from the area of future anastomosis before construction of gastric tube and just before~     creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with~     systemic venous blood.~      The investigators suppose that elevation of acid features of blood (pH decreasing, lactate~     increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the~     significant predictive sign for future anastomotic leaks or strictures.~      After operation the investigators plan to find relationship between the blood gas changes~     and rate of anastomotic leak and stricture.~      This is prospective study. Anticipated cohort of 50 patients~   "
38992|NCT02546674|"~     The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS <~     0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic~     phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML')~     laboratories adequate and reliable molecular monitoring as a key parameter for assessing~     molecular milestones is fostered. Furthermore this trial aims to investigate early~     prediction of outcome in newly diagnosed patients with nilotinib by assessing the individual~     decline of BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24~     questionnaire.~   "
38993|NCT02546661|"~     This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, randomised~     Phase 1b study in patients with muscle invasive bladder cancer (urothelial) who have~     progressed on prior treatment. This study is modular in design, allowing evaluation of the~     safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as~     monotherapy and as combinations of different novel anti-cancer agents in patients with~     muscle invasive bladder cancer.~      The study will consist of a number of study modules (substudies), each evaluating the safety~     and tolerability of a specific agent or combination.~   "
38994|NCT02546648|"~     A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic~     acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative~     cardiovascular event.~   "
38995|NCT02546635|"~     Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states)~     Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the~     fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose~     of AX-024.HCl following a meal.~      Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).~      Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose~     study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects.~     Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects~     with 9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive~     placebo.~      There will be a data review following each dose level. Dose administration in the subsequent~     cohorts will only proceed after satisfactory data review on the blinded safety data and~     plasma PK data in the previous cohort.~   "
38996|NCT02546622|"~     This is a longitudinal, observational study of patients with Hemophilia A or B who are~     planning to switch to a newly approved coagulation factor replacement product, or who have~     recently switched factor products. The study will follow each patient for up to 1 year.~     Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates.~     The primary outcome being studied is the development of inhibitor (i.e., antibodies to~     factor) at 1 year or 50 exposure days, whichever comes first.~      The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600~     patients.The entire study duration is projected to be approximately 6 years.~      In addition, optional substudies will be included for some products, as Product-Specific~     Modules. These will be questionnaires to collect data for subjects receiving selected~     Factor products. For example, subjects receiving Eloctate will be approached to participate~     in the 'Eloctate Product-Specific Module'; subjects receiving Adynovate will be approached~     to participate in the 'Adynovate Product-Specific Module'. Questions will be related to~     product use, perceptions of product use, and other post-marketing consumer data.~   "
38997|NCT02546609|"~     The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in~     patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare~     two doses of NS-0200 to placebo in NAFLD patients.~   "
39079|NCT02545543|"~     This is a study to assess the immune (antibody) response and safety of a Seqirus split~     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US~     licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric~     population 5 through 17 years of age.~   "
38998|NCT02546596|"~     Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of~     complete resection and anal sphincter preservation. However, a treatment period of from 5 to~     6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is~     confronting challenges for maximizing the therapeutic effect and minimizing the side~     effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of~     problems. In this clinical trial, therapeutic effect of the high-frequency~     electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced~     rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.~   "
38999|NCT02546583|"~     Effective diuresis is the primary goal of most acute decompensated heart failure~     hospitalizations, but diuretic resistance is common and our ability to detect it is limited.~     Further, there are therapeutically distinct groups of diuretic-resistant patients. These are~     not easily distinguished using currently available methods, leading to trial-and-error based~     treatment that promotes lengthy hospitalizations.~      The aims of this study are:~        1. To develop inexpensive and efficient tools to predict diuretic response~        2. To understand the prevalence of therapeutically targetable mechanisms of diuretic~          resistance using endogenous lithium clearance~        3. To develop methodology to differentiate diuretic resistance mechanisms using~          common/inexpensive laboratory tests~        4. To provide proof of concept that mechanistically tailored diuretic therapy can improve~          natriuresis~   "
39000|NCT02546570|"~     The investigators will use multiple methods (including Oxytocin intranasal inhalation,~     neuroimaging, behavioral measures, peripheral hormone measurements) to examine how~     individuals' behavior, cognition, and brain function is impacted by the neuro-hormone~     Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin~     administration on affective processing in non-trauma exposed and trauma-exposed adults (both~     with and without posttraumatic stress disorder, PTSD).~   "
39001|NCT02546557|"~     The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene®~     suture concerning its key indication.~   "
39002|NCT02546544|"~     This is an international, multi-centre, single arm Bayesian designed phase 2 study to~     identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with~     relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7~     European centres. Each patient will be treated with single agent linsitinib, 600 mg orally~     once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue~     toxicity.~   "
39003|NCT02546531|"~     In pancreatic cancer, targeting the tumor microenvironment has become a promising~     therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for~     promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have~     demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a~     maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a~     PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the~     concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint~     immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in~     the proposed phase I trial.~   "
39004|NCT02546518|"~     Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children~     in the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss.~     Although spontaneous resolution with normalisation of hearing is the usual outcome, this can~     take several months. Secretory otitis media is the most common cause of hearing impairment~     in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists~     for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia~     is indicated. In Sweden, 10000 children undergo this operation annually. Although many~     children with unilateral or bilateral SOM improve in the summer, the problem usually recurs~     in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish~     crowns 2005.~      In two previous studies, the investigators concluded that the nonsurgical treatment method,~     that was developed to assist children with SOM equalising their middle ear pressure, could~     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.~     These children avoided therefore grommet insertion.~      The investigators would like to assess the effect of this new treatment method on mainly the~     hearing threshold of children with SOM. The investigators expect that using the new method~     could help children with SOM avoid operation with grommet insertion.~   "
39005|NCT02546505|"~     Introducing Front-Of-Pack (FOP) nutrition labelling, providing simplified information on~     nutritional content at a glance, in order to help consumer make informed choices, has been~     identified as of major interest by public health specialists. In France, a recent report to~     the Minister of Health has proposed the introduction of a Front-of-Pack nutrition label, the~     5-Colour nutrition label. Existing studies on FOP labels mainly focused on assessment of~     consumers' acceptability/liking and understanding. If most of the studies on purchasing~     behavior, conducted in real supermarkets, suggested a positive effect of FOP labels on~     consumers' food choices, the impact of the 5-CNL has not been evaluated.~      The main objective is to evaluate the impact of a Front-of-pack nutrition label, the~     5-Colour Nutrition Label on consumer purchases in a controlled environment close to~     real-world settings. Nutritional quality of the items purchased will be compared using the~     Food Standards Agency nutrient profiling system (FSA score). The study relies on a~     comparison across three independent samples :~        -  Control group: The current situation with current way brands show or not nutritional~          information on Front of Pack (FoP) - without consumer information~        -  Intervention n°1: Introduction of a Front-of-pack nutrition label (5-CNL) on selected~          categories of foods. No additional consumer information~        -  Intervention n°3: Introduction of a Front-of-pack nutrition label (5-CNL) on selected~          categories of foods. Additional consumer information specifically targeting nutritional~          information and explaining the 5-CNL will be performed (this information will consist~          in a concept shown to respondents before the shopping session).~      Participants are recruited in the street through quota sampling, based on criteria of~     gender, age and purchasing habits on the products categories selected for the introduction~     of the FOP nutrition label.~      The study relies on LabStores®, i.e. shopper laboratory stores, which are controlled study~     spaces in which a store is recreated in reality.The real lab store mimics a store~     environment with real shelves, product, and cash register, and presents several product~     categories in a realistic shopping environment. At the end of the shopping session, the~     respondents proceed to the cashier but don't actually pay for their purchases.~      The selected foodstuffs come from actual retailers' brand products available on the French~     market. Three categories of products were selected, based on expected variability in~     nutritional quality of the products and logistic criteria (exclusion of fresh products):~        -  Breakfast cereals~        -  Sweet biscuits~        -  Salty snacks The impact of the different labels on nutritional quality (FSA score,~          calories, lipids, saturated fatty acids, sugars, proteins, fibre, sodium) of the~          shopping cart is investigated using one way ANOVA. Pairwise comparisons among FOP~          labels are assessed by using Tukey's multiple comparisons tests.~      All tests of significance are two-sided, and a P value <0.05 is considered significant.~     Statistical analyses are performed using SAS software (version 9.3; SAS Institute Inc.).~   "
39006|NCT02546492|"~     This is an open label safety and feasibility trial using Acthar® in addition to the~     investigators center-specific standard therapy, which could include increase in maintenance~     immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.~   "
39007|NCT02546479|"~     Background:~      Scoliosis is a curving of the spine. It usually happens in girls when they are children and~     teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may~     increase the risk that those young women get cancer later in life. Researchers want to learn~     more about this risk. They will look data that has already been collected.~      Objectives:~      To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study~     death risks related to certain scoliosis patient characteristics. These include causes,~     kinds of curvature, and kinds of treatment.~      Eligibility:~      Medical records of women from past scoliosis studies.~      Design:~      This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912~     and 1965.~      Data were collected on these women in the 1980s and 1990s. These came from medical records,~     radiology log books, and x-ray films. Researchers found out where participants were,~     including if they were dead. Some women were given a follow-up questionnaire.~      Researchers want to find out where participants are today. They want to identify new deaths~     of participants. They want to find out their causes of death. This data will be added to~     other databases.~   "
39008|NCT02546466|"~     Background: Low back pain is a major public health problem that affects most people at some~     point in life, and results in major psychosocial, economic, functional and physical~     consequences that can last for days and months. Most cases are undiagnosed and become~     chronic non-specific low back pain. Studies showed that these patients presented changes in~     postural control, yet the information is inconsistent, as well as the effects of Functional~     Taping (FT).~      Objectives: The aim of this study will be to investigate the immediate and one-month~     follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and~     postural control in patients with chronic nonspecific low back pain (CLBP).~      Methods: This study will be a sham-controlled and randomized clinical trial. Participants:~     One hundred and twenty participants (18 and 50 years) both genders. Interventions:~     Participants will be randomly allocated to receive three possible interventions: Functional~     Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a~     Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be~     pain intensity and posturography to assess balance parameters. Low back pain related~     disability, global perceived effect of treatment and fear avoidance beliefs will be~     considered as secondary outcomes. Four measurements of static posturography will be~     conducted: pre-intervention, immediately after application of the tape, after seven days~     post-intervention (after removal of the tape) and after one month follow-up period.~     Secondary and primary outcomes will be assessed on three occasions: pre-intervention, seven~     days post-intervention and after one month follow-up period. All statistical analysis will~     be conducted following the principles of intention to treat, and the effects of treatment~     will be calculated using linear mixed models.~   "
39009|NCT02546453|"~     The search for genetic alterations in primary tumor by NGS techniques followed by the~     detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral~     samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several~     steps and after the treatment could be a tool to monitor the response during and after the~     treatment.~   "
39010|NCT02546440|"~     The main objective of the trial is to investigate whether oral treatment of patients~     suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant~     improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks~     of treatment (primary endpoint). Secondary endpoints will be CTCL severity index,~     dermatologic life quality index, itching measured by a VAS and the blood involvement if~     applicable.~      Primary: safety and efficacy of DMF treatment in CTCL Secondary: CTCL severity index,~     Dermatologic Life Quality index, VAS for itching, blood involvement if appl.~   "
39011|NCT02546427|"~     This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole~     pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate~     cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node~     involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the~     study will be defined as the time of first LHRH/agonist/antagonist injection of hormone~     therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the~     first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every~     3 months for the first 24 months after completion of radiotherapy in a similar schedule to~     usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire~     will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be~     documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed~     after the first follow-up visit of the20th patient enrolled on protocol. The trial will be~     terminated if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result~     of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal,~     local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically~     significant but not immediately life-threatening event requiring hospitalization or~     prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5%~     incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally~     fractionated radiotherapy followed by brachytherapy.~   "
39012|NCT02546414|"~     To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese~     patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.~   "
39013|NCT02546401|"~     The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin~     and commonly used in the treatment of type 1 diabetes, where it obtained the marketing~     authorization for this indication. In the patient who have an insulin pump, insulin Aspart~     is given daily like a pre-prandial bolus (just before the meal). However, many patients~     perform their bolus after the meal. However this insulin administration modality is not~     clearly studied in the literature.~   "
39014|NCT02546388|"~     The purpose of this research study to find out if a drug called OctreoScan can help doctors~     diagnose people with cardiac sarcoidosis better.~      OctreoScan is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain~     tumors.~   "
39015|NCT02546375|"~     The purpose of this study is to describe the efficacy and safety of bosutinib in patients~     with chronic myeloid leukaemia used in a real world setting~   "
39016|NCT02546362|"~     The objective of this pilot open trial is to investigate the efficacy and safety of e-TNS~     with the Cefaly(R) device in fibromyalgia.~   "
39080|NCT02545530|"~     The majority of chronic hemodialysis patients need a combination of several antihypertensive~     drugs for adequate BP control. The primary objective of this study is to evaluate whether~     transdermal clonidine can improve blood pressure control or decrease oral antihypertensive~     agents type or dosage and the secondary objective is to observe incidence of adverse~     reactions of transdermal clonidine in chronic hemodialysis patients.~   "
39081|NCT02545517|"~     The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and~     to assess the boostability of immune responses in subjects who received a primary series of~     accelerated or conventional rabies PrEP IM regimen.~   "
39017|NCT02546349|"~     It is recognized that eosinophilic airway inflammation is more likely respond to steroid~     treatment. However, in real-world practice, it is difficult to routinely assess airway~     inflammation using sputum induction because of technical and facility requirement. COPD~     (chronic obstructive pulmonary disease) is a heterogeneous disease and it remains a great~     challenge to identify patients who have eosinophilic airway inflammation and respond to~     steroid treatment well. A recent study demonstrated elevated plasma D-dimer was associated~     with acute inflammation and a significant predictor of pulmonary embolism in COPD~     exacerbated patients. D-dimer may potentially act as a marker of inflammation and a~     predictor of cardiovascular event in COPD patients. The investigators preliminary study~     demonstrated that exhaled nitric oxide (eNO) > 23.5 ppb is a good surrogate marker to~     predict eosinophilic airway inflammation in COPD patients who were newly diagnosed or~     untreated for at least 3 months. There were significant correlations among sputum~     eosinophils, eNO and serum total immunoglobulin E (IgE). Particularly, eNO predicted sputum~     eosinophilia (> 3%) in COPD at a sensitivity and specificity of 62% and 71% respectively.~     Herein, the investigators test the hypothesis that eNO may act as a biomarker to determine~     treatment option for COPD.~   "
39018|NCT02546336|"~     Hip osteoarthritis (HOA) is a common cause of pain and disability in aging population.~     Conservative treatment is based on lifestyle modifications, physical therapy, analgesic and~     anti-inflammatory medications and intra articular injections. This Prospective Pilot Study~     aims at investigating the efficacy of Ultrasound-Guided Cooled Radiofrequency Hip~     Denervation as a treatment offered to patients with HOA.~   "
39019|NCT02546323|"~     The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to~     placebo for treating Chinese patients with subclinical atherosclerosis.~   "
39020|NCT02546310|"~     To determine if treatment with HTL0009936 will lead to changes in neural activity, measured~     using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and~     working memory, learning and executive functioning.~   "
39021|NCT02546297|"~     The purpose of this study is to determine which treatment is more effective and safer for~     the patients in COPD C group with bronchiectasis.The research results will help guide~     physicians to select appropriate individualized treatment and hopefully provide some~     evidence-based medicine proofs for revising guide.~   "
39022|NCT02546284|"~     This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate~     safety, pharmacokinetics, and clinical activity.~   "
39023|NCT02546271|"~     Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive~     gay and bisexual men, which takes place in a group counselling format. All participants~     provided written informed consent at the outset of the study. Eligible participants filled~     out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants~     attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay~     men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS~     program, participants were scheduled to attend a 1-hour session to complete the same~     questionnaire package. Participants received an honorarium and a list of community~     resources, including mental health or substance use counseling services, at the end of each~     assessment. Participants also participated in a program evaluation interview at the 3-month~     follow-up assessment.~   "
39024|NCT02546258|"~     This is a prospective, open label, non-comparative clinical investigation to evaluate the~     performance of a Fungal Nail Treatment on the visual signs of onychomycosis.~      The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially~     available as an over-the-counter product.~      The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail~     infections will be determined by a reduction in the surface area of the infection over time.~     This will be assessed through visual quantification of the infected area from baseline, as~     measured by image analysis, throughout the treatment period, where subjects will follow~     instructions for use on the product pack and self-treat for the duration of the~     investigation or until their condition has resolved. Both subject and podiatrist will assess~     the improvement of signs and symptoms of the target nail.~   "
39025|NCT02546245|"~     The goal of the proposed research is to adapt and rigorously evaluate educational mobile~     games, designed as a downloadable mobile apps to be played on smartphones or tablets.~     Investigators will be partnering with Yogome for this project. Yogame is a company dedicated~     to creating educational games that aim to reinforce knowledge acquired in school and help~     children learn new things in an entertaining and fun way.~   "
39026|NCT02546232|"~     The purpose of the study is to investigate the molecular biology of the tumor in relation to~     treatment response to chemotherapy, in particular paclitaxel compared to the combination~     paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:~      Cohort I: Patients with large primary breast cancer (> 2.0 cm) including locally advanced~     disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline~     containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to~     receive carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.~      Cohort II: Patients with metastatic disease, available for biopsies before and during~     therapy are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to~     receive paclitaxel alone or paclitaxel in combination with carboplatin.~   "
39027|NCT02546219|"~     The overall objective of this preclinical study is to further the investigators mechanistic~     understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule~     (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the~     investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin~     expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE~     esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of~     eosinophil integrin molecules that may play a role in active EoE.~   "
39082|NCT02545504|"~     The primary objective of this study is to compare the efficacy of GS-5745 versus placebo in~     combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA)~     (mFOLFOX6) as measured by overall survival.~   "
39151|NCT02544607|"~     Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease~     has been shown to last for up to one month. MRI technology will be used before and after~     ketamine for patients with depression to examine the extent to which certain brain areas~     predict ketamine's antidepressant effects.~   "
39028|NCT02546206|"~     The aim of this study was to evaluate the effects of probiotic yoghurt on the development of~     gingival inflammation.~      Fifty-one periodontally healthy individuals were given standard oral hygiene instructions~     and randomly divided into two groups. The test group subjects (n=26) consumed probiotic~     yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25)~     natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was~     interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and~     clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing)~     were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in~     GCF by ELISA.~   "
39029|NCT02546193|"~     Induction of labor, or causing labor to start before it otherwise starts spontaneously, is~     sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.~     Labor induction often begins with cervical ripening, in which various methods are used to~     prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases~     the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant~     women are admitted to the hospital at the start of this process and remain inpatient until~     after the baby is born.~      There is increasing interest in allowing the mother to return to her own home during the~     very first part of this process. She may be more satisfied in a more comfortable environment~     with her family. Growing scientific evidence supports use of the Foley catheter as an~     approach to outpatient cervical ripening. The Foley catheter is a safe, effective method~     that is already used often in the inpatient setting. It does not cause increased health~     risks for either mother or baby. Previous research studies have shown that it is just as~     safe and effective when women return to their own homes with a Foley catheter and that women~     spend less time in the hospital before delivery. More information is needed before this~     becomes a standard of care. This research study will allow pregnant women to return home for~     the first night of their labor induction with a Foley catheter in place. In the morning they~     will return to the hospital and stay until after delivery. They will be compared to a group~     of women who remain in the hospital for their entire labor induction. The benefits to going~     home during labor induction may include increasing maternal satisfaction and optimizing the~     use of resources in the hospital.~   "
39030|NCT02546180|"~     This prospective randomized pilot clinical trial studied the effect on preoperative anxiety~     of watching a series of YouTube videos designed to create a virtual hospital experience for~     patients undergoing primary total hip and knee arthroplasty as compared to routine~     preoperative education.~      Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be~     reduced by patient exposure to a virtual hospital inpatient experience delivered by a series~     of YouTube videos.~   "
39031|NCT02546167|"~     Open-label, single-center, pilot study to assess the safety and feasibility of infusion of~     autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen~     receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in~     adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose~     intravenous infusion over 3 days. The duration of active intervention and monitoring is~     approximately 2 years.~   "
39032|NCT02546154|"~     The objective is to monitor and quality assure the efficacy, including effects on quality of~     life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease~     patient populations when Monofer® is used according to the Monofer® label (Summary of~     Product Characteristics, SPC) in current clinical practice and where standard routines are~     being followed.~   "
39033|NCT02546141|"~     This study was designed to obtain information about the change in postprandial amino acids~     in blood over time, after consumption of different dairy products, in an elderly population~     and how this relates to gastric emptying rate and feelings of satiety.~   "
39034|NCT02546128|"~     To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured~     home-exercise programme has any additional benefit to patients with tendinopathies~   "
39035|NCT02546115|"~     To assess whether the provision of a tension night splint (TNS) device has any additional~     benefit in patients with chronic plantar fasciitis, compared to routine care comprising~     physiotherapy & podiatry alone.~   "
39036|NCT02546102|"~     ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are~     pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA)~     present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients~     with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care~     chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with~     the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target~     glioblastoma tumour cells.~   "
39037|NCT02546089|"~     To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI),~     which includes a dry-needling component within the overall procedure, has any measureable~     clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar~     fasciitis.~   "
39038|NCT02546076|"~     Skin injuries due to trauma are relatively common, and patients are very concerned about~     scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative~     lasers based on the fractional approach has become a novel strategy for the treatment of~     scars.~      The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering~     pulses either with and without heat/coagulation in a cohort of patients with long~     keloid/hypertrophic scars.~      The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent~     to laser with heat/coagulation in terms of scars volume reduction, while the secondary~     hypothesis is that ablative fractional laser without heat/coagulation is superior in terms~     of post-operative erythema and hypopigmentation reduction.~   "
39096|NCT02545322|"~     Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy~     concept. This involves the adaption of the radiotherapy treatment plan according to changes~     in tissues and variations in patients position and posture during a radiotherapy treatment~     course, based on repeat CT scans.~      It is investigated, if dosimetric improvements can be achieved using this approach and if~     the method using the software-package ReDeform can be implemented in clinical Routine.~   "
39152|NCT02544594|"~     This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus~     standard treatment alone in patients with cardiogenic shock due to myocardial infarction.~   "
39039|NCT02546063|"~     The standard method for determining the carbohydrate content of a meal in patients with~     diabetes mellitus is the weighing of individual foods. However, in daily life, the weighing~     is not practical at all times. Inaccurate estimation of meal's CHO content, leads to wrong~     insulin doses and consequently to poor postprandial glucose control. Fact is that even well~     trained diabetic individuals find it difficult to estimate CHO precisely and that especially~     meals served on a plate are prone to false estimations underlining an emergent need for~     novel approaches to CHO estimation.~      GoCarb is a computer vision-based system for calculating the carbohydrate content of meals.~     In a typical scenario, the user places a credit card-sized reference object next to the meal~     and acquires two images using his/her smartphone. A series of computer vision modules~     follows: the plate is detected and the different food items on the plate are automatically~     segmented and recognized, while their 3D shape is reconstructed. On the basis of the shape,~     the segmentation results and the reference card, the volume of each item is then estimated.~     The CHO content is calculated by combining the food types with its volumes, and by using the~     USDA nutritional database. Finally, the results are displayed to the user.~      A preclinical study using the GoCarb system indicates that the system is able to estimate~     the meal's CHO content with higher accuracy than individuals with T1D. Furthermore, the~     feedback gathered by the participants showed that the system is easy to use even for~     non-smartphone users.~      The aim of this randomized, cross-over pilot study is to investigate the benefits of an~     automated determination of the carbohydrate content of meals on glycemic control in subjects~     with type 1 diabetes mellitus with sensor-augmented insulin pump therapy.~   "
39040|NCT02546050|"~     OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes~     in metabolic markers in urine, saliva, blood and fecal samples following metformin~     treatment.~      DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week~     pre-intervention period, 6-week intervention period and a 6-week post-intervention period.~     25 healthy young men will be included in the trial.~      INTERVENTION: Six-week Metformin treatment to young healthy men.~   "
39041|NCT02546037|"~     Primary Objective:~      The purpose of this study is to measure the amount of convection achieved with two different~     haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration~     treatment.~   "
39042|NCT02546024|"~     Depression is a common disorder, especially in old age, where it is associated with~     significant morbidity and mortality.~      This study will investigate whether there are features of individual patients with major~     depression that may predict positive treatment response. The study will invite 40 patients~     who have been diagnosed with major depressive disorder with onset after the age of 60 years~     to participate. Participants will be recruited from the Mental Health of Older Adults~     services at the South London and Maudsley NHS Mental Health Foundation Trust. Participants~     will receive usual treatment as set out in standard Care Pathways, used by the clinical care~     team. As part of the study, they will undergo a short battery of neuropsychological tests~     and a standard MRI brain imaging protocol. The neuropsychological tests and assessment of~     depression severity will be carried out twice (at Baseline and Week 12). Data will be~     analysed to investigate whether there are features specific to those patients who show a~     good response to antidepressant treatment after 12 weeks. Identification of such predictors~     may help to stratify treatment approaches in the future and lead to the early identification~     of individual patients who may require alternative treatment approaches to standard~     antidepressants.~   "
39043|NCT02546011|"~     The goal of this study is to compare the amount of time that the fetal heart tones are~     traced in babies just at or beyond viability using a traditional device compared to the~     Monica device.~   "
39044|NCT02545998|"~     The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies~     in both primary and secondary care resulting in one of the highest mortality rates in~     Europe. A key recommendation in the report is the provision of an annual asthma review in~     primary care.~      Telehealthcare is an alternative means of service delivery incorporating the use of~     telephone and e-mail consultations which may improve access and quality of patient care.~     There is scant data on the role of teleheathcare in asthma care.~      This is a single-centre, primary care-based, randomized controlled trial to evaluate the use~     of telehealthcare to conduct the annual asthma review for adult patients with~     well-controlled asthma. This will be compared with standard care (face-to-face~     consultations).~      Telehealthcare will consist of a telephone consultation followed by an e-mail with an~     attached personalised asthma action plan and a link to a video demonstrating inhaler~     technique.~      Standard care will involve a face-to-face consultation in primary care. The two patient~     groups will be compared prospectively to determine whether there is a difference in the~     quality of care evaluated in terms of the patient experience/ satisfaction, health-related~     quality of life, asthma control and frequency of asthma exacerbations over a 6 month period~     after the asthma review.~      The data will be presented in the form of frequency tables, bar charts and pie charts.~     Non-parametric tests will be applied to determine whether there is a significant difference~     in the quality of care received.~   "
39045|NCT02545985|"~     The aim of this study was to assess the safety and the efficacy of the novel~     sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.~   "
39046|NCT02545972|"~     This study investigates the use of tacrolimus extended release in stable patients who have~     undergone a heart transplant. All patients will receive the study medication free of charge~     for the 1 year duration of the study.~   "
39047|NCT02545959|"~     The goal of investigators is to study the kinetics of action of a single dose of~     intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in~     progressive MS patients. Various markers of central nervous system inflammation~     (osteopontin, Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament)~     are studied at multiple time-points, assuming that a definitive action upon CSF biological~     targets would be strongly predictive of a delayed clinical action.~   "
39048|NCT02545946|"~     Comparing the outcome of traditional incision and drainage with a larger skin incision with~     or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive~     incision and drainage with two small incisions and a vessel loop transversing the incisions~     to keep them open.~   "
39049|NCT02545933|"~     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the~     standard of care for the long-term secondary prevention of atherothrombotic events in~     patients with myocardial infarction (MI). However, rates of ischemic recurrences remain~     high, which may be in part due to the fact that other platelet signaling pathways, such as~     thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a~     protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of~     thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug~     Administration for the reduction of thrombotic cardiovascular events in patients with a~     history of MI or with peripheral arterial disease. However, to date clinical trial~     experience with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor~     clopidogrel and the effects of vorapaxar in combination with antiplatelet therapy including~     prasugrel or ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a~     dual antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with~     withdrawal of aspirin, represents another important area of clinical interest as it has the~     potential to maximize ischemic protection while reducing the risk of bleeding. The proposed~     prospective, randomized, parallel-design, open label, study conducted in a real world~     clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of~     vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor~     (prasugrel or ticagrelor) with and without aspirin.~   "
39050|NCT02545920|"~     This is a prospective observational pilot study of patients under the care of the Royal Free~     Hospital with chronic kidney disease who have been established on regular thrice weekly~     haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the~     ear during haemodialysis.~   "
39051|NCT02545907|"~     This study evaluates the safety and efficacy of carfilzomib used in combination with~     thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins~     with a dose escalation phase, in which the maximum tolerated and recommended dose will be~     determined. The trial will then open into an expansion phase in which the combination~     efficacy is assessed.~   "
39052|NCT02545894|"~     People with global aphasia (PwGA) post stroke have little to no meaningful communication~     abilities (ie limited comprehension, spoken language, reading and writing abilities).A~     proportion of PwGA will also have limited abilities to use any alternative means of~     communication e.g. gesture, pictures or computer devices. There is a suggestion in the~     literature that this is because of co-occurring cognitive deficits. The consequence is that~     these clients are unable to reliably communicate even their basic needs.This is commonly~     known as having no functional communication abilities. Such PwGA tend not to respond to~     standard speech and language therapy interventions.~      This research will investigate the effect of a new cognitive intervention designed to~     improve basic functional communication abilities. The treatment will be nonverbal and~     involve computer and paperbased tasks ordered hierarchically from basic to more complex~     tasks. Six to eight participants will take part. All their sessions will take place in their~     own home. For some this may be a care home. They will first complete a diagnostic~     communication assessment in order for baseline abilities to be established. Further formal~     language and cognitive assessments will be conducted over a period of 6 weeks. A~     relative/friend will complete a questionnaires about mood/communication. The PwGA will also~     be videoed interacting with the research student e.g. looking at a magazine, completing a~     jigsaw, answering questions and making choices non-verbally.~      The participants then receive the new intervention 3 times a week for 6 consecutive weeks.~     All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks~     using the same assessments as prior to the intervention. The questionnaire with their~     relative/friend and videoed activity session will also be repeated. After a twelve week~     break the participant will be videoed interacting with the research student complete some of~     the assessments again and their relative will re-complete the questionnaires.~   "
39053|NCT02545881|"~     The purpose of this study is to develop, validate, and evaluate the correlation of novel~     magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and~     histological data obtained during prostatectomy.~   "
39054|NCT02545868|"~     This multicenter, randomized, open-label study will evaluate the immune response to vaccines~     (tetanus toxoid [TT], 23-valent pneumococcal polysaccharide vaccine [23-PPV], influenza~     vaccine, and keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab~     (OCR) in participants with relapsing multiple sclerosis (RMS).~   "
39055|NCT02545855|"~     This is a prospective, randomized crossover study for evaluation of the efficacy and safety~     of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD~     patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)~     and hypercapnia who require home oxygen therapy (HOT). The total duration of subject~     participation will be 52 weeks, consisting of 12-week treatment period and 40-week~     continuation period. Subjects who satisfy all inclusion and exclusion criteria will be~     randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus~     HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy~     plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the~     myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects~     can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm~     assignment. The end of the study is defined as the treatment period or continuation period~     end date of the last participant, whichever is later. Subjects will primarily be assessed by~     the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24~     and 52.~   "
39056|NCT02545842|"~     Primary Objective:~      To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients~     using insulin glargine which can provide the highest control rate of glycated hemoglobin~     (HbA1c) < 7%.~      Secondary Objectives:~      The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients~     achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage~     of patients achieving the FPG target without hypoglycemia. The percentage of patients~     achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10~     mmol/L).~   "
39057|NCT02545829|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1302 and HGP1406 in healthy male volunteers.~   "
39097|NCT02545309|"~     SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely~     unclear. The investigators hypothesize that genetic variants of biliary transporter genes~     are frequent in patients with SSC-CIP. In approximately 140 patients and controls the rate~     of genetic variants in biliary transporter genes, gut permeability and gut microbiome as~     well as bone health will be studied.~   "
39098|NCT02545296|"~     HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care~     tests for very early infant HIV diagnostics in infants born to HIV infected mothers in~     Mbeya, Tanzania.~   "
39058|NCT02545816|"~     After any acute brain injury, a primary pathophysiological response arises, enabling the~     brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in~     patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain~     injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without~     any clinical motor signs, which are then termed as nonconvulsive, and therefore remain~     frequently clinically unrecognized. As such, it is of great importance that these patients~     are diagnosed as early as possible since the increased metabolic demand and blood flow~     associated with an epileptic insult may further compromise the brain at risk. Thus far,~     continuous EEG (cEEG) is the only clinical instrument that is able to detect the development~     of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is~     labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore,~     a more simple and prognostic accurate EEG device is highly warranted to detect seizures in~     an early stage so that patients might benefit from a specific and early treatment. A~     validation study in comatose patients with an acute neurological insult will be conducted to~     provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect~     epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG~     monitoring could possibly be used to facilitate the prognostication and management of~     epileptic seizures in this patient cohort which could eventually improve the clinical~     outcome.~   "
39059|NCT02545803|"~     Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may~     result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma~     and postoperative complications. In an attempt to preserve or increase the oxygenation,~     conventional mechanical ventilation is initiated in these patients. Unfortunately, patients~     frequently become refractory to standard ventilatory techniques and as such, gas exchange~     remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the~     other hand, is an advanced mode of ventilation which can be a salvage option in these~     patient cohorts as it has already been proven to improve gas exchange with success. The~     volumetric diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only~     commercially available system to deliver HFPV. This ventilator mechanically ventilates the~     lung by administering small successive subtidal volumes or percussions at unconventional~     high frequencies to reach an optimal diffusive oxygenation.~      Since it has been known that hypoxemia due to a reduced oxygenation results in secondary~     brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as~     well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range~     has an ameliorative influence on hypoxic events and in turn leads to a better clinical~     outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation~     by means of a switch to HFPV automatically leads to an increment in the cerebral tissue~     oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators~     will investigate whether this alternation of ventilation strategy is associated with a~     (beneficial) change of the cerebral tissue oxygenation.~   "
39060|NCT02545790|"~     This study is designed to learn more about children who have blockage of the left side of~     their heart. The goal is to determine how much the heart muscle has thickened before surgery~     and how it changes in the months after surgery. Investigators are also looking for blood~     tests that may help them predict which patients will have the most thickening~     pre-operatively and the best return towards normal after surgery. The findings of this study~     will help the investigators develop new tests to monitor affected patients and develop new~     therapies to help minimize heart thickening.~   "
39061|NCT02545777|"~     This research is based on spleen trapped by dampness and turbid which is the pathogenesis of~     gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In~     this study, the investigators use multi-center randomized parallel controlled clinical~     trials.The treatment groups are afforded oral traditional Chinese medicine~     decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet~     wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a~     positive control drug.The outcome is evaluated by condition of symptoms remission,pain~     relief time, recurrence rate and laboratory index to determine the efficacy of internal and~     external treatment.And the research will provide optimized diagnosis and treatment program.~     The investigators hope this research will also get tonifying spleen and descending the~     turbid internal and external treatment for gouty arthritis effective clinical treatment.~   "
39062|NCT02545764|"~     Childhood obesity is one of the most critical and accelerating health challenges throughout~     the world. It is a major risk factor for developing varus/valgus misalignments of the knee~     joint. The combination of misalignment at the knee and excess body mass may result in~     increased joint stress and damage to articular cartilage. A training programme, which aims~     at developing a more neutral alignment of the trunk and lower limbs during movement tasks~     may be able to reduce knee loading during locomotion. Despite the large number of guidelines~     for muscle strength training and neuromuscular exercises that exists, most are not~     specifically designed to target the obese children and adolescent demographic.~      The purpose of this study is to evaluate a training programme which combines strength and~     neuromuscular exercises specifically designed to the needs and limitations of obese children~     and adolescents and analyse the effects of the training programme from a biomechanical and~     clinical point of view.~   "
39063|NCT02545751|"~     Patients with esophageal cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response after Stereotactic Body Radiation~          Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and~          thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study~          will help find out what effects (good or bad) the combination of radiotherapy and~          thymalfasin has on metastatic esophageal cancer.~   "
39064|NCT02545738|"~     The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2~     diabetes.~   "
39137|NCT02544789|"~     Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are~     dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate~     the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients~     with R/R ALL~   "
39065|NCT02545725|"~     This study is collecting data on quality of life, (care)needs and socio-economic factors in~     colorectal (ex-)cancer patients via a written questionnaire completed by the patient~     him/herself. The collected data will be linked with the patient- and tumour characteristics~     available in the database of the Belgian Cancer Registry and with the facturation data~     supplying information about diagnostic techniques and performed treatments (available via~     the insurance companies).~      Based on the selection criteria, 1220 patients were finally selected from the database of~     the Belgian Cancer Registry. These patients received an invitation letter by regular mail, a~     detailed questionnaire and an informed consent.~      The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction~     with the provided information, care needs, quality of life, anxiety and depression,~     financial situation etc.~      The patients were asked to complete the questionnaire and send it back, together with the~     signed informed consent, to the study-collaborators.~      After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient~     doesn't want to participate in this study, a reason can be mentioned on the reply card.~      The collected data are linked with the clinical data. The dataset will be coded before~     analyses will start.~   "
39066|NCT02545712|"~     The purpose of this study is to explore the quantity of excipient exposure in neonatal and~     young pediatric patients in a Danish Hospital. The focus will be on the preservatives~     ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and~     propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame,~     glycerol and sorbitol.~   "
39067|NCT02545699|"~     The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™~     colonoscopy with that of standard colonoscopy.~   "
39068|NCT02545686|"~     CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing~     and chest wall motion.~   "
39069|NCT02545673|"~     The purpose of this study is to evaluate the effectiveness of a linkage to care intervention~     at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time~     to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among~     people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural~     Uganda.~   "
39070|NCT02545660|"~     During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is~     because food easily accumulates around the braces and it is more difficult to clean when the~     braces are in place. The plaque accumulation can lead to demineralisation (white spots)~     developing on the teeth. This is the start of decay and can lead to permanent marks and~     fillings being required.Prior to the start of orthodontic treatment adequate oral hygiene is~     necessary.~      During orthodontic treatment, it is important that patients have an excellent level of oral~     hygiene to prevent plaque accumulating and demineralisation occurring. However, adequate~     tooth brushing can be difficult to perform as the bacterial plaque is not easily visible.~     Thus patients may not be able to see which areas need better tooth brushing.~      QLFD(Quantitative Light Induced Fluorescence Digital) is a noninvasive method that uses~     fluorescent light to illuminate the oral bacteria in plaque that are responsible for~     demineralisation. The purpose of this study is to use the QLFD camera to assess its ability~     to measure plaque accumulation and demineralisation before the start of orthodontic~     treatment. The study will also assess the QLFD camera as a tool to improve oral hygiene.~   "
39071|NCT02545647|"~     A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient~     because weight regain can occur. An intervention to prevent weight regain in the future is~     to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB)~     which increases weight loss and decreases weight regain on the longer term. The question is~     whether primary application of a banded bypass gives a greater weight loss and / or prevent~     weight regain in the future versus a standard RYGB.~   "
39072|NCT02545634|"~     The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052~     and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on~     symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might~     be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to~     examine the effects of probiotics on saliva cortisol levels. Finally, the investigators are~     also interested in the effects of the probiotics on children's digestive health.~   "
39073|NCT02545621|"~     RAGE (the receptor for advanced glycation end-products) is a marker of alveolar type I cell~     injury and a pivotal mediator of acute inflammation and innate immunity. RAGE pathway is~     highly regulated; the interaction of the transmembrane receptor with its various ligands~     (e.g. HMGB1, S100A12) ultimately leads to NF-kB activation and RAGE upregulation itself, but~     precise RAGE functions and intracellular pathways remain underexplored. During ARDS,~     monocyte and macrophage activation could modulate alveolar inflammation and repair.~      As RAGE is also expressed at the surface of monocytes/macrophages, we hypothesize that~     alveolar monocyte/macrophage activation may be mediated through a RAGE-TXNIP (thioredoxin~     interacting protein)-NLRP3/inflammasome intracellular pathway. The purpose of this~     observational prospective study is to compare alveolar monocyte/macrophage activation~     profiles (as assessed by Fluorescence-Activated Cell Sorting (FACS)) in mechanically~     ventilated patients with or without ARDS.~   "
39074|NCT02545608|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Vital~     for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will~     be done by a blinded evaluator.~   "
39075|NCT02545595|"~     This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40~     kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor~     is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At~     the end of the procedure, patients with profound neuromuscular blockade receive either 1~     mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure~     is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex~     or if recurarization occurs within 15 min after complete reversal success.~   "
39076|NCT02545582|"~     This registry will observe patients with symptomatic heart failure with implantable vagus~     nerve stimulation to provide insights into safety and efficacy during clinical routine.~   "
39077|NCT02545569|"~     The purpose of this evaluation is to receive the greatest benefit of new custom made hearing~     product technology and shell modification for the end customer and to continual improve the~     custom made hearing products.~   "
39083|NCT02545491|"~     Background: Responsive stimulation and/or enhanced nutrition interventions delivered to~     children through health programs shows improved cognitive, language, and motor, and the~     social-emotional status. This could benefit young children in Lebanon and worldwide to~     improve their developmental potential.~      Aim: This study aims to implement Care for Child Development (CCD) intervention for children~     aged 0-3 years within a supportive environment in Day Care Centers and to investigate its~     effectiveness on early child development.~      Methodology: CCD program will be implemented in 10 randomly selected daycare centers in~     Lebanon where three providers in each center will be trained (CCD-group). Another group of~     10 day care centers will serve as controls (WV-group). 228 Children in each group will~     receive either early stimulation based on CCD and education from the World Vision Infant and~     Young Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project~     (WV-group). Caregivers' knowledge and behaviors will be assessed before and after the~     intervention using a predetermined questionnaire and behavioral checklist. Early child~     development will be assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale~     for infant Development (BSID-III).~      Expected Outcome: Implementation of CCD program in day care centers will be feasible and~     will lead to enhanced early child development. This study will serve as a prototype for~     program implementation throughout the country and the region.~   "
39084|NCT02545478|"~     The purpose of this investigation is to evaluate how early biomarkers of infection and~     inflammation perform in identifying patients at risk for poor outcome in sepsis and septic~     shock.~   "
39085|NCT02545465|"~     The aim of this study is to understand the treatment patterns in patients with Pulmonary~     Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during~     a switch of treatment to Adempas in real-life clinical practice.~      In addition, this study will describe patient demographics and reason for switching~   "
39086|NCT02545452|"~     To investigate the pharmacokinetic effect of a vaginally administered antimycotic~     (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of~     tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel~   "
39087|NCT02545439|"~     This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics~     of ALKS 5461.~   "
39088|NCT02545426|"~     Chronic kidney disease (CKD) is linked to elevated mortality rate, and cardiovascular~     disease is the main cause related to this outcome. The cardiovascular mortality among~     patients on conventional hemodialysis (CHD) is high, achieving up to 30 times more risk of~     death when comparing to individuals of same age on general population. Congestive heart~     failure can develop in 25% to 50% of patients, leading to a worse prognosis. CKD patients~     present anatomic and functional abnormalities on peripheral bed vases and also~     cardiovascular abnormalities that can cause myocardial ischemia. This last usually is~     transitory and lead to left ventricular dysfunction that can persist even after the end of~     dialysis session despite normal coronary perfusion. The prolonged dysfunction is called~     myocardial stunning (MS). Patients on CHD are subject to hemodynamic instability, myocardial~     ischemia and development of regional abnormalities of myocardial wall (ARPM´s). MS induced~     by intradialytic ischemia is a complication that can be minimized by applying techniques~     associated to more stability during the CHD, as cool dialysate or increasing the length of~     the therapy. The goal of the present study is to evaluate the behavior of cardiovascular~     system (trough hemodynamic performance during CHD, accessing MS by echocardiography~     technique, and biomarkers associated to MS). Finally, the investigators aimed to investigate~     the role of two different dialysate calcium concentration (2,5 and 3,5 mEq/l) in the genesis~     of MS during CHD. The elucidation of pathogenesis of MS during CHD might help us modified~     hemodialysis technique in order to prevent MS, and reduce the high cardiovascular mortality~     among CKD patients.~   "
39089|NCT02545413|"~     Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal~     pain and/or discomfort is associated with changes in bowel habit, and with features of~     disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of~     quality of life in affected individuals.The high prevalence of IBS is accompanied by large~     societal economic burdens and negative effects on the quality of life in affected patients.~     It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M~     mixed sub type.~   "
39090|NCT02545400|"~     This study aims to assess the frequency and severity of adverse events during Hepatitis C~     therapy with or without first generation protease inhibitors.~   "
39091|NCT02545387|"~     Patients with hepatitis C show impaired neutrophil function. It is not known whether this is~     a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis~     C it is possible to see whether neutrophil granulocyte progenitors are already infected with~     hepatitis C.~   "
39092|NCT02545374|"~     Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds~     compared with the usual care(with or without CICAT-LR Network).~   "
39093|NCT02545361|"~     The purpose of this study is to evaluate the safety and to determine the Dose Limiting~     Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.~   "
39094|NCT02545348|"~     This is an obstervationnal study, to evaluate the good clinical practice of the use of the~     sentinel node biospy in early stage endometrial cancer. The collaborating centres with the~     OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc~     will also particpate to the trial.~      Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading~     team in the world published very good result and that the first prospectives trials are~     already published with also excellents results. The investigators decided then to include~     this practice in their institutional guideslines and also to registred the procedure.~   "
39095|NCT02545335|"~     The aim of this study is to characterize neutrophil function in patients undergoing chronic~     hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with~     peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate~     the possible mechanisms of protease-inhibitor associated infections.~   "
39138|NCT02544776|"~     On the basis of the current study, amlodipine seems to be a promising drug on improving~     uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level~     and pregnancy outcome in patients with pco.~   "
39099|NCT02545283|"~     This study is designed to compare Overall Survival (OS) in participants with relapsed or~     refractory Acute Myeloid Leukemia (AML) treated with idasanutlin in combination with~     cytarabine versus participants treated with placebo and cytarabine. Participants will~     receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding~     patients may continue to receive a maximum of further two cycles of consolidation (Cycle 2~     and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp),~     overall remission rate (ORR), event-free survival (EFS), leukemia-free survival (LFS) and~     percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will~     also be compared between treatment arms. This study will include participants without (TP53~     wild-type) and with TP53 mutations.~   "
39100|NCT02545270|"~     It is of great importance to obtain optimal surgical conditions for the surgeon in order to~     increase patient safety. The effect of different interventions on surgical conditions has~     been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has~     previously been tested in a proof-of-concept trial - but not validated - during radical~     retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace~     using video sequences.~      In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by~     investigators group, investigators are using a 5-point scale to rate the surgical workspace~     during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is~     based on previously used scales by already published studies and has a description connected~     to each point. To the authors' knowledge the scale has never been validated in a~     laparoscopic setting, where the intra-abdominal pressure during pneumoperitoneum can have a~     great influence on visualization. In fact, to investigators knowledge, no validated~     surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery~     does exists.~      Purpose:~      Primary aim:~      To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations~     of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal~     video recordings.~      Secondary aims:~      To validate a 10-point rating scale by investigating the inter-rater agreement of~     evaluations of the surgical workspace at different intra-abdominal pressures.~      To test the agreement between the two rating scales. To assess which of the two rating~     scales has the highest inter-rater agreement To assess the intra-rater agreement of both~     rating scales.~      Hypothesis:~      Investigators hypothesize that the 5-point rating scale has an intra-class correlation~     coefficient (ICC) > 0.6., validated by video-sequences obtained during laparoscopic surgery.~   "
39101|NCT02545257|"~     The objective of this randomized controlled trial is to develop a coordinated,~     multiprofessional medication management model for home-dwelling aged in primary care and to~     study the effectiveness of this model. The main hypothesis is that the new model helps to~     identify aged people having potential risks with their medications and thus allows solving~     these risks.~   "
39102|NCT02545244|"~     The study was conducted to measure the effectiveness of Black Tea in reducing the deposits~     on teeth. It also compares the effect between use of black tea mouthwash and green tea~     mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks~     long clinical trial among adults of 18-40 years of age.~   "
39103|NCT02545231|"~     To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal~     hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and~     near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse~     cardiovascular events during 3-year follow-up.~   "
39104|NCT02545218|"~     The perineal body is commonly injured during labor. It is possible to perform a secondary~     repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed~     perineal tear. The aim of the randomized trial is to evaluate the results of such an~     operation compared with conservative treatment.~   "
39105|NCT02545205|"~     The overall purpose of this project is to establish the added value of training with the~     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation~     intervention programs after stroke.~      The main specific aims are:~        -  to demonstrate the effect of training with HAL as part of current, best available,~          regular inpatient rehabilitation in comparison with the effect of current, best~          available regular inpatient rehabilitation programs only, in the post acute phase~          (starting 4-7 weeks) after stroke with regard to gait and cardio-vascular function,~          activity and participation;~        -  to explore factors that predict outcome/good responders to training with HAL;~        -  to estimate health care utilisation and cost effectiveness of using the HAL during the~          first year after stroke.~   "
39106|NCT02545192|"~     The investigators propose to make the first observations of LFMS treating a population of~     subjects with PTSD. A positive outcome for this study could translate directly into a new~     treatment modality for symptoms of PTSD in both acute and chronic situations. The~     investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in~     the treatment of PTSD.~   "
39107|NCT02545179|"~     Purpose:Effect of web-based daily care training on the quality of life of caregivers of~     children with cerebral palsy.~      study design: Single-blind clinical trial. study population: Caregivers of children with~     cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who~     spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in~     Alborz province that clinical diagnosis of cerebral palsy registered in their clinical~     records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver~     have facilities and basic knowledge of using Internet (Declared access to the Internet at~     least one hour a week). exclusion criteria: taking care of two or more children with~     disability. participated in previous face to face training programs.~      Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week.~     Outcome of the study: the quality of life of caregivers~   "
39108|NCT02545166|"~     This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting~     acute cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy.~     The study will also investigate whether blood purine levels are indicative of future risk of~     stroke by comparing pre-operative blood purine levels in carotid endarterectomy patients~     (high risk group) and blood purine levels in a group of age and sex-matched controls.~   "
39109|NCT02545153|"~     Bile leak reduction from the common bile duct, as a result of glue appliance after~     cholangiotomy.~   "
39110|NCT02545140|"~     The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk~     assessment tool to identify those children with chronic disease risk factors (including Type~     2 Diabetes).~   "
39111|NCT02545127|"~     This trial investigates the safety and efficacy of FE 202767 compared to placebo in~     increasing milk production in subjects with preterm delivery and inadequate milk production.~   "
39139|NCT02544763|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The blinded phase only will be described in this record. Participants will receive 1 of 2~     doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will~     be a difference between GWP42003-P and placebo in their effect on seizure frequency.~   "
39112|NCT02545114|"~     Hyponatremia occurs frequently in patients with acute brain injury in the days to weeks~     following injury, and may contribute to adverse outcome. In addition, hyponatremia can~     aggravate neurologic dysfunction, complicate neurological assessments, and contribute to~     neurologic symptoms such as gait dysfunction that can impair efforts at mobilization and~     rehabilitation. Strict normonatremia (serum Na levels between 135 and 145 meq/dl) is the~     goal in most patients with acute brain injury. SIADH is the most frequent cause of~     hyponatremia in patients with neurological injury; however, treatment with fluid restriction~     is often difficult or contra-indicated, for example in patients with subarachnoid hemorrhage~     (SAH) where intravascular hypovolemia can trigger vasospasms. The aim of this project is to~     test Tolvaptan, an ADH antagonist, as a treatment in selected patients with acute brain~     injury who have developed SIADH.~   "
39113|NCT02545101|"~     This is a retrospective chart review non-interventional study designed to collect real world~     data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia~     secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.~   "
39114|NCT02545088|"~     The overall purpose of this project is to establish the added value of training with the~     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation~     intervention programs after stroke.~      The main specific aims are~        -  to demonstrate the effect of intensive training with HAL in comparison with intensive~          training without HAL and with standard care only, in a later phase (1-10 years) after~          stroke with regard to gait and cardio-vascular function, activity and participation;~        -  to estimate health care utilisation and cost effectiveness of using the HAL during the~          first year after stroke.~   "
39115|NCT02545075|"~     The purpose of this study is to determine whether Ipilimumab will extend the life of chinese~     patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to~     examine safety in this patient population.~   "
39116|NCT02545062|"~     T2D and cognitive impairment are two of the most common chronic condition found in persons~     60 years and older. Diabetes type 2 increases with age and studies suggest that the diabetes~     is one of the risk factor for cognitive impairment and dementia.~      Although there is much recent research showing that diabetics at every age have more~     cognitive impairment and dementia than non-diabetics, relatively little attention has been~     paid to the implications of this complication in the management of T2D in terms of~     screening, prevention, education and treatment adherence.~      There are now guidelines for periodic evaluation of patients with diabetes as early~     detection of complications of the disease, but so far there are no similar assessment and~     monitoring of cognitive function.~      In this study the investigators examine cognitive function in young diabetic patients (from~     20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may~     be carried out during a visit, an annual advisory diabetes clinic.~   "
39117|NCT02545049|"~     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition~     to standard daily therapy, is effective and safe in treating patients with type 2 diabetes~     mellitus and diabetic kidney disease, when compared to a placebo.~   "
39118|NCT02545036|"~     The annual report of USRDS shows than Taiwan has the highest prevalence of~     end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major~     factors associated with chronic renal failure are age, diabetes, hypertension, chronic~     glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic~     kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And~     these possible prognostic factors associating with the disease progression and ultimately~     increase the morbidity and mortality. End-stage renal failure is an irreversible course~     often with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients~     often use Chinese medicine or acupuncture to help them to ease the symptom.~      The aim of this study is to investigate the efficacy of combined Western medicine and~     traditional Chinese medicine daycare model for chronic kidney disease patients. The study~     approach to investigate whether combination of Western medicine and traditional Chinese~     medicine daycare model can improve the clinical symptoms and quality of life as well as the~     laboratory biochemistries data.~   "
39119|NCT02545023|"~     This phase I/II research trial studies supportive care questionnaires in gathering data on~     unmet needs and health-related quality of life in Latina breast cancer survivors after~     surgery, chemotherapy, or radiation therapy. Questionnaires that address unmet supportive~     care needs and health-related quality of life of breast cancer survivors may help doctors~     learn about barriers to cancer care that are linked to language, acculturation, knowledge~     about diagnosis and care, and financial concerns. Learning about unmet needs of breast~     cancer patients may help increase quality of life and decrease healthcare utilization and~     costs.~   "
39120|NCT02545010|"~     Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic~     malignancies and is the fifth leading cause of cancer death in women in the United States.1~     Despite initial high response rates, 50% to 75% of women who present with advanced disease~     suffer relapse and require re treatment2.The optimal treatment for platinum resistant~     ovarian cancer remains hotly debated. Combination chemotherapy is not favored due to its~     increased toxicity and lack of convincing benefit when compared to single agent~     chemotherapy.3,4 Recently, the addition of bevacizumab to single agent chemotherapy in the~     AURELIA study improved progression free survival (PFS) from 3.4 months to 6.7 months.~     Response rates were also improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine~     the maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART. The~     recommended phase II dose (RP2D) will be based on the MTD in this Phase I study. Method:~     This study is designed as a prospective, single arm phase I study with 3+3 with dose~     de-escalation and cohort expansion. All patients will receive weekly paclitaxel at a pre~     specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according~     to institution specific standard practices. Cycles of chemotherapy will be administered~     weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in~     combination with LDWART(Fig.1). LDWART will be given at 60 cGy fractions, twice daily for~     two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle~     of weekly paclitaxel for 6 weeks.(Fig.1). Importance of proposed research: The combination~     of a LDWART with weekly paclitaxel may improve the efficacy of the current standard weekly~     paclitaxel in platinum resistant ovarian cancer patients. Potential benefits and risks: The~     combination may improve treatment response. Adding LDWART may increase treatment risks, but~     these will be monitored closely.~   "
39140|NCT02544750|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase.~     The open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
39121|NCT02544997|"~     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective~     therapeutic strategies including targeted agents.~      Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with~     feasible toxicity for MBC patients as a salvage treatment strategy after failure of~     anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with~     other salvage agents, especially for patients with HER2 overexpression breast cancers.~     Additionally, a recent report showed that possible rational background for patients with~     HER2 mutation-positive breast cancers.~      Based on this rationale, the investigators are to conduct phase II single-arm study of~     poziotinib for patients with MBC who showed refractoriness to conventional treatments as~     salvage treatment.~   "
39122|NCT02544984|"~     The purpose of this study is to determine if the prophylactic use of azithromycin will~     reduce the total number of days when unscheduled treatment is given outside of the home in a~     clinic, urgent care, emergency room or hospital setting between the respiratory illness~     season months (October 1-March 31) and subsequent 2 month follow-up (April and May)~   "
39123|NCT02544971|"~     Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many~     individuals exposed to aversive events. The severity of PTSD symptoms is positively~     correlated with amygdala activation. More severe PTSD symptoms following exposure to~     stressful events, are associated with amygdala hyper-responsivity prior to exposure. A~     possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned~     self-modulation of neural activity in response to feedback of neural signal. Previous work~     in our lab established a NF training procedure that utilizes the temporal abilities of EEG~     with the spatial advantages of fMRI. Further work based on this method using the amygdala~     BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability~     to self-regulate amygdala activity and to improve emotional regulation in a healthy~     population. The current study aims to investigate the potential of this method as a~     therapeutic intervention for PTSD.~   "
39124|NCT02544958|"~     To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the~     treatment of enlarged pores.~   "
39125|NCT02544945|"~     This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for~     breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber~     substance placed on the skin to modify the radiation beam). The hypothesis is that 3D~     printed bolus will conform more closely to the chest wall than standard 5mm-thick standard~     bolus and thus lead to less chance of underdose or overdose of the skin. Each patient will~     receive the standard dose of radiotherapy, but half the treatments will use standard bolus~     and half the treatments will 3D printed bolus (ie each patient will act as is their own~     control). The primary outcome is the comparison of the amount of air under the bolus for~     each technique. Secondary outcome is the amount of time it takes to set up the patient for~     radiotherapy.~   "
39126|NCT02544932|"~     Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms~     including endothelial dysfunction of heart and vessel. This study was designed to determine~     the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of~     atherosclerosis of AF subjects.~   "
39127|NCT02544919|"~     To study the impact of pretreatment of living donor liver transplantation recipients with~     SMOF lipid on the incidence and severity of post-transplantation neurological complications~     in patients receiving tacrolimus based immunosuppression protocol~   "
39128|NCT02544906|"~     The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in~     LDLT recipients~   "
39129|NCT02544893|"~     we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine~     for ultrasound guided thoracic paravertebral block in thoracotomy~   "
39130|NCT02544880|"~     The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived~     Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune~     response and promote a permissive environment that should increase the efficacy of~     anti-tumor vaccine in a setting of minimal residual disease.~   "
39131|NCT02544867|"~     An emerging body of epidemiological evidence suggests that various forms of sedentary~     behavior, including TV viewing, occupational sitting, and total daily sitting, may be~     associated with all-cause and cardiovascular mortality, overweight and obesity, type 2~     diabetes, depression and psychological well-being. Importantly, many of these associations~     were independent of participation in moderate to vigorous intensity physical activity. We~     propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of~     two interventions targeting sedentary behavior. Since it is currently unknown what component~     of sedentary behavior exposure presents the greatest risk to health, we propose separate~     interventions to reduce overall sedentary time and to promote breaks in sedentary time.~   "
39132|NCT02544854|"~     By measuring plasmatic concentration of propofol at different intervals during surgery of~     children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for~     cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model~     of propofol for children.~   "
39133|NCT02544841|"~     The purpose of the study is to determine the impact of the offer to participate in Safer Sex~     Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health~     (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and~     frequency of sex) six months after the end of treatment.~   "
39134|NCT02544828|"~     The objective of the present study is to determine the impact of intraoperative IV-iron~     supplementation on postoperative oxygenation profile by comparing the postoperative~     PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective~     uni-limb arthroplasty surgery.~   "
39135|NCT02544815|"~     AHFS management is challenging and most of the used drugs has failed to decrease~     post-discharge mortality and readmission rates which represent the most important goal in~     AHFS.~      Digoxin processes many characteristics of a beneficial drug for heart failure, however~     recent publications has rose concerns about its safety profile and therefore decreasing its~     use.~      Whether digoxin is efficient and safe in short term treatment of acute heart failure is a~     question that should be studied.~   "
39136|NCT02544802|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of autologous~     adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary~     osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed~     to subjects at a weekly interval.~   "
39141|NCT02544737|"~     Patients with esophageal cancer that had metastatic lesions after been treated with surgery~     or definitive chemoradiotherapy are being asked to participate in this study.~      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine~     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that~     of vatalanib or sorafenib.~      The purpose of this study is to determine what effects apatinib has on metastatic esophageal~     cancer. These effects include whether apatinib could shrink the tumor or slow down its~     growth and what side effects apatinib will have on the tumor.~   "
39142|NCT02544724|"~     NM-IL-12 is being evaluated as an immunotherapeutic with concomitant hematopoietic~     regenerating properties for treatment of relapsed/refractory DLBCL, an aggressive type of~     B-cell non-Hodgkin's lymphoma (NHL). Determination of the maximum tolerated dose (MTD) for~     NM-IL-12 is not planned in this study, rather, a pre-defined dose of 150 ng/kg will be~     explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy~     volunteers.~   "
39143|NCT02544711|"~     Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare~     pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases~     in France per year).~      The reference treatment is a surgical en bloc resection associated or not to a medical~     treatment. This surgery remains highly challenging because of the complex three-dimensional~     geometry of the pelvic bone and the proximity of important organs and neurovascular~     structures. The local recurrence rate is significantly increased when the resection does not~     respect a safe tissues margin (R0 margin).~      A new technology has been developed and used in different reference sites the Patient~     Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and~     reliable surgical gesture, leading to more frequent R0 margins.~      The main objective of this study is to compare the efficiency of the PSI for bone tumor~     resections within the pelvis with respect to the reference method.~   "
39144|NCT02544698|"~     This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy~     People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including~     18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and~     2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will~     receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.~   "
39145|NCT02544685|"~     Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer~     patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the~     main sources of infections during neutropenia. Competitive inhibition of gut mucosal~     colonization by pathogenic microorganisms using synbiotics could represent one of the~     potential options for its prevention. Synbiotics represent combination of two components:~     probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or~     food supplements administered at a sufficient dose help to maintain health beneficial~     microbial balance in the digestive tract of a human or other host. Prebiotics are food~     ingredients nondigestible for our digestive enzymes, but can be fermented by bacteria in our~     bowel and this way selectively stimulate growth or activity of specific saccharolytic~     bacterial strains. These changes in composition of our microflora may bring benefits on host~     well-being and health. Based on the results of human and animal studies, probiotics probably~     can not only decrease the level of gut colonisation with pathogenic bacteria, but may also~     lead to reduction in the duration of neutropenia, accelerate the restitution of the~     intestinal mucosa and boost immunity. Despite a significant number of studies on probiotics~     still only little evidence of their safety especially in immunocompromised patients is~     available.~      To help find new options for increasing quality of healthcare for children cancer patients~     and also to evaluate safety of this new approach investigators designed double-blinded~     placebo controled multicenter study aimed to decrease the number of febrile episodes using~     prevention with synbiotic.~   "
39146|NCT02544672|"~     The objective of this study is to evaluate the functional benefits of a myoelectric~     Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular~     accident (CVA).~   "
39147|NCT02544659|"~     This study is designed to evaluate long term efficacy of intravenous bisphosphonates for~     bone marrow edema in patients with SAPHO syndrome.~   "
39148|NCT02544646|"~     It has been hypothesized that the biomechanical properties of the optic nerve head and/or~     sclera play a role in the development of glaucoma. One approach of gaining insight into the~     biomechanical properties of the eye by the means of clinical studies is based on the~     Friedenwald equation, representing a pressure-volume relationship. This equation represents~     the so called ocular rigidity, which expresses the elasticity of the globe.~      In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA)~     with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude~     (PA) have to be performed.~      In addition choroidal thickness will be assessed with OCT before and after trabeculectomy,~     since results in choroidal thickness measurements in patients with glaucoma are~     controversial.~      The focus of this study lies on the changes of ocular rigidity and choroidal thickness after~     surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or~     pseudoexfoliation glaucoma (PEX).~   "
39149|NCT02544633|"~     MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and~     other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,~     unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic~     changes of the MET gene (mutation or amplification [increase number of gene copies]).~     Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients~     must have previously received treatment with chemotherapy. The number of patients to be~     enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265~     will be administered orally, twice daily. The study is designed to evaluate whether the~     number of patients experiencing tumor size reduction is substantially higher than would be~     expected with other available treatments.~   "
39150|NCT02544620|"~     The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement,~     Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup.~     The design is as an observational prospective study, evaluating patients that fulfil~     discharge criteria on the day of the surgery. The investigators will further evaluate safety~     aspects, such a early morbidity and mortality, as well as patient satisfaction.~   "
39153|NCT02544581|"~     This is an exempt, retrospective study of a limited set of information obtained from~     patients' medical records at 10 to 12 substance abuse treatment programs combined with~     alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study~     objectives are 1) to compare the compliance rates and likelihood of achieving sustained~     sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated~     monitoring programs and 2) identify components within patients' monitoring agreements that~     are significantly correlated with positive outcomes.~   "
39154|NCT02544568|"~     Meal composition is important for blood sugar levels in patients with diabetes. The aim of~     this study is to investigate if a meal composition of fat, protein and carbohydrate is~     important for the hormonal and inflammatory responses Patients with type 1 and type 2~     diabetes and healthy controls will be included in the study. At four different occasions the~     participants will receive lunch with the same amount of calories but different composition~     of fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the~     meals. The participants will estimate their satiety. In addition participant will fill in~     questionnaires about their food habits and wellbeing.~      This study is the first study to compare both hormonal and inflammatory responses, as well~     as psychological aspect of the meals, after meals with different composition. Results from~     this study will help to make recommendation about meal composition which is beneficial for~     patients with diabetes type 1 and type 2.~   "
39155|NCT02544555|"~     There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal~     arterial lesion with guide wire. One is the intraluminal approach of passing guide wire~     through the atheroma, the other is the subintimal approach of passing wire through the~     subintima of the vessel.~      Either of these two interventional technique can be chosen depending on the character of the~     lesions they have their own pros and cons which affects the success of the intervention. The~     study is limited to retrospective studies to which interventional technique is better for~     post-procedural recurrence rate, however there is no prospective randomized controlled~     study.~   "
39156|NCT02544542|"~     This study will try to evaluate the effectiveness and safety of a new method for achieving~     mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be~     treated by the widely-used hyper-hypothermia blanket method, while the other half will be~     treated by the investigators' new method.~   "
39157|NCT02544529|"~     The purpose of this study is to test the hypothesis that myopia progression can be slowed or~     prevented by low dose Echothiophate Iodide.~   "
39158|NCT02544516|"~     In schizophrenia, dislocation of psychic functions involving a loss of contact with reality~     is frequently found. A fragmentation of motor and sensory perceptions could be held~     responsible (Fuchs, 2005). However, automatic integration between perception and action is~     the necessary condition to be in relationship with the world. Affordance is the~     experimental link between object perception and actions potentially associated (Gibson~     (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of~     visual motor neurons leads us to postulate that the affordance effect can be assisted by a~     visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor~     compatibility task, we study the capacity of affordance in schizophrenia, as well as the~     impact of perceptual motor priming on these affordance effects.~   "
39159|NCT02544503|"~     The purpose of this study is to identify and establish how the area of the brain that~     controls motor function (motor cortex) might serve as a new focus for treatment for stroke.~     The therapeutic intervention aims to identify protocols that improve motor performance after~     stroke.~   "
39160|NCT02544490|"~     The objectives are to:~        1. derive and validate a panel of miRNAs that are consistently differentially expressed in~          the plasma of patients with and without sepsis~        2. investigate the prognostic and predictive values of the panel of miRNAs to guide~          treatment~        3. investigate the roles of these differentially-expressed circulating miRNAs in immune~          modulation during sepsis~      The methodology involves sampling of blood from controls and subjects in the sepsis~     continuum at their earliest presentation in the emergency department longitudinally to~     hospitalization. The investigators will develop panels of miRNAs that are specific to early~     and late stages of sepsis, and correlate clinical, biochemical and microbiological outcomes~     with these miRNAs.~   "
39161|NCT02544477|"~     The primary objective of this study is to evaluate the effect of early application of nasal~     high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative~     hypoxemia.~   "
39162|NCT02544464|"~     The objective of the present study is to determine the impact of intraoperative IV-iron~     supplementation on postoperative oxygenation profile by comparing the postoperative~     PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective~     uni-limb total knee arthroplasty surgery.~   "
39163|NCT02544451|"~     Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic~     fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator~     (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233).~     Study 110 is designed to evaluate the safety and efficacy of long term treatment of~     lumacaftor in combination with ivacaftor.~   "
39164|NCT02544438|"~     A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of~     Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid~     Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease~   "
39165|NCT02544425|"~     Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone,~     L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell~     transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.~   "
39166|NCT02544412|"~     The purpose of this project is to study whether a mindfulness-based training program~     supports self-regulation, resiliency, effective classroom behaviors, and persistence in~     teaching.~   "
39179|NCT02544243|"~     Development of an active second-line treatment option for metastatic breast cancer patients~     previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or~     palliative settings.For each randomisation arm, 100 patients will be included. The trial was~     performed as a 2-stage phase II study according to the optimal design by Simon with overall~     response rate as the primary objective.~      Study Design:~      Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25~     mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks~   "
39167|NCT02544399|"~     After the age of 50, one in three women and one in eight men will experience at least one~     fragility fracture during the rest of their lives. It is currently recognized that physical~     activity has an osteogenic actions, especially when it includes the impact transmitted to~     the skeleton. In this context, the investigators propose a study to determine whether the~     regular practice of golf could be particularly beneficial for the skeleton, not only in the~     lower limbs, due to repeated impacts to the ground when it requires sustained walking, but~     also the upper limbs due to the impacts transmitted by the club at the time of striking the~     ball, as has been amply demonstrated with racquet sports.~   "
39168|NCT02544386|"~     In hemiplegic, there is very little data on the impact of neurological deficit on the~     microarchitecture independent of bone mineral density and composition of the bone marrow.~     Rare studies have shown the relationship between some micro-architectural parameters and~     severity of neurological deficit. There is no study in humans on the evolution of the~     parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of~     the installation of neurological deficits after stroke, in terms of a bearing bone, tibia,~     that a non-load bearing bones, radius.~   "
39169|NCT02544373|"~     The objectives of this study are to determine the effects of obstructive sleep apnea (OSA)~     on cognitive function in patients with multiple sclerosis (MS); and to evaluate whether OSA~     treatment with positive airway pressure therapy could improve cognitive dysfunction in MS~     patients who have OSA.~   "
39170|NCT02544360|"~     The purpose of this study is to determine whether photoaging mobile app promoting poster~     campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is~     measured via questionnaire.~   "
39171|NCT02544347|"~     The aim of the present study were 1) to determine the role of these adipokines in the~     pathogenesis of periodontal disease, inflammation and tissue destruction comparing with~     gingival crevicular fluid (GCF) levels of TNF-α, which has a known pro-inflammatory effect~     in periodontal disease, 2) to investigate the effect of non-surgical periodontal treatment~     on GCF vaspin and omentin levels in type 2 diabetic (T2DM) patients with Chronic~     Periodontitis (CP).~   "
39172|NCT02544334|"~     Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2~     million in the United States. The role of environmental factors in modulating autoimmunity~     pathogenesis has been clearly described and yet the specific mechanisms of action remain~     poorly understood. A growing body of evidence implicates microbiota of mucosal surfaces in~     the development of autoimmune disorders. Various studies have clearly linked RA to~     periodontal disease. The latter is linked to the red-complex that includes the oral~     bacterium Porphyromonas gingivalis. And yet there has not been a systematic analysis of the~     oral microbiota in RA to determine whether there are specific markers for P. gingivalis (and~     other oral bacteria) that are linked to RA.~      In this study, the investigators will characterize oral microbial composition (microbiome)~     and gene content (metagenome) of DNA isolated from oral samples obtained from patients with~     (i) early stage RA prior to biologics treatments and (ii) subsets of RA patients who are~     responsive or unresponsive to anti-TNF-alpha therapy. The innovative aspect of this study is~     going beyond the identification of oral bacterial species, to the level of strains and genes~     that are associated with these groups. The overall hypothesis is that oral microbial~     variation exists between individuals that influences development of autoimmunity and~     autoimmune disease.~   "
39173|NCT02544321|"~     Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance~     (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and~     glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)~     agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its~     recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an~     exciting development, representing a novel mechanism for improving IR. BCQR has not been~     studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data~     support the proposed study of possible benefits of BCQR on insulin action, glycemic control,~     and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR~     in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This~     is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes~     will include fasting and postprandial glucose, glycemic variability, insulin dosing,~     hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.~   "
39174|NCT02544308|"~     The purpose of the trial is to establish whether adjuvant therapy with lenalidomide +~     dexamethasone after radiotherapy can improve progression free survival in patients with high~     risk solitary bone plasmacytoma compared with RT only.~   "
39175|NCT02544295|"~     The objective of this research is to develop original virtual reality scenarios and/or new~     virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit~     disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies~     interfering with sleep/wake disorders.~   "
39176|NCT02544282|"~     In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy~     with axillary node dissection will be randomly assigned to general anesthesia with opioids~     combined with a Pecs II block or to general anesthesia with opioids combined with a placebo~     Pecs II block. Participants will be followed postoperatively during their entire hospital~     stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II~     block and opioids as postoperative pain treatment.~   "
39177|NCT02544269|"~     The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal~     anesthesia for hip replacement. Half of participants will receive lumbosacral plexus~     blockade and the other half will receive continuous spinal anesthesia.~   "
39178|NCT02544256|"~     The purpose of this study is to determine whether mild hypothermia causes reduction of~     vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow~     in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of~     vasospasms during the period of 14 postoperative days measured by transcranial Doppler.~   "
39180|NCT02544230|"~     The investigators retrospectively evaluated the efficacy of granulocyte transfusions as~     adjunctive treatment for severe infections in neutropenic fever unresponsive to~     antimicrobial therapy in hematological patients.~   "
39181|NCT02544217|"~     Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders~     affecting both children and adults. KH176 is a novel chemical entity currently under~     development for the treatment of inherited mitochondrial diseases, including MELAS~     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's~     Disease and LHON (Leber's Hereditary Optic Neuropathy). KH176 is a potent intracellular~     redox modulating agent targeting the reactive oxygen species which are important in the~     pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a~     favourable safety profile in the pre-clinical testing, the safety, tolerability and~     pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in~     healthy male subjects in this trial~   "
39182|NCT02544204|"~     To investigate the efficacy of the administration of JVS-100 delivered via direct~     intramuscular injections on a 3 month and 6 month composite endpoint of wound progression,~     healing and limb loss in patients with severe peripheral arterial disease with non-healing~     chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment~     of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.~   "
39183|NCT02544191|"~     Preliminary reports showed that hormonal treatment may improve the chance of retrieving~     viable testicular sperm from men with NOA. It was generally believed that gonadotrophin~     treatment would be ineffective in the presence of high plasma levels of endogenous~     gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing~     hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal~     gonadotropin) are effective in the treatment of non-obstructive azoospermia.~   "
39184|NCT02544178|"~     The survival time and the number of long time survivors after radiotherapy in brain cancer~     patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic~     effects of this therapy gains more and more importance. Among these side effects, the main~     and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the~     white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence~     rate assessment, as well as the occurrence time, is based on retrospective studies with low~     numbers of patients, but seems to reach 30 to 50 % of the patients according to the~     follow-up. The risk seems to be increased during the first two years after the radiotherapy,~     but persists for decades.~      To gain further insight in the radiation-induced leukoencephalopathy, the objective of this~     project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective~     cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using~     specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive~     bio-markers of cognitive impairments.~   "
39185|NCT02544165|"~     The aim of this study was to investigate the difference in accumulation of AGEs (advanced~     glycation end-products) in the tissues of individuals who smoke in comparison with~     individuals who do not as well as of individuals who consume caffeine versus those who do~     not, and finally to examine the probable differences concerning participants' haemodynamic~     parameters.~   "
39186|NCT02544152|"~     A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.~   "
39187|NCT02544139|"~     This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard~     reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.~      The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the~     qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole~     blood samples. Reactive assay results are presumptive evidence of Chagas infection.~      This study will enroll males and females 18-70 years of age from areas non-endemic for~     Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to~     serum) will be collected from each subject. Subject age, gender, and symptoms will be~     recorded. For this study, samples will have no personally identifiable information.~      CDP and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples~     from each method independently.~   "
39188|NCT02544126|"~     The purpose of this study is to investigate how working with a computer program may affect~     mood, feelings, overall health, and markers in blood in young adults with HIV.~   "
39189|NCT02544113|"~     This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult~     patients receiving a single organ liver transplant from a deceased donor; the purpose being~     to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the~     long-term preservation of renal function after liver transplantation. This study is based on~     the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic.~      This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups:~     Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose)~     with delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI~     initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or~     any other antibody).~      All subjects will also receive a maintenance immunosuppressive regimen consisting of~     corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in~     orthotopic liver transplantation (OLT).~      Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT.~     There are 15 study-related visits which will be completed during standard of care (SOC)~     visits.~   "
39190|NCT02544100|"~     The purpose of this study is to create a neonatal neurologic biological big data center~     named Neonatal Neurologic Intensive Care Network in China with neonatal systematic~     information, biological samples and genomics & genetic data on neonates born with neonatal~     severe encephalopathy. It also can predict brain injury as cerebral function monitoring~     through big data and recommend appropriate treatment. In addition, the following samples~     will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid~     (CSF) samples.~   "
39191|NCT02544087|"~     The present study is designed to confirm the therapeutic effects of heat-clearing and~     blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction~     (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action~     involved from the standpoint of pathology, cell and molecular biology, as well as~     immunology.~   "
42480|NCT02500953|"~     The objectives of this study are to evaluate the safety and tolerability of a single and~     multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the~     pharmacodynamics of ASP3325 orally administered three times a day.~   "
39192|NCT02544074|"~     The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive~     assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia.~     SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable~     forms allows it to be given in almost any setting, does not require any staff time to~     administer and makes it practical to rapidly screen large numbers of individuals in the~     community or in their home.This trial is being conducted to study the validity of SAGE in a~     digital format (eSAGE) for cognitive screening.~      The investigators will analyze the data to learn the correlations between eSAGE and gold~     standard neuropsychological testing designed to differentiate normal cognition from MCI and~     early dementia. The investigators will also find out whether the paper (SAGE) and electronic~     (eSAGE) versions of SAGE could be used interchangeably or not.~   "
39193|NCT02544061|"~     The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative~     to standard of care (SOC; control) in subjects with open surgical wounds.~   "
39194|NCT02544048|"~     Background:~      People with malaria often show altered immune responses to many illnesses and vaccines. This~     means that the malaria might cause immune suppression. It is not clear how or which vaccines~     are impacted by malaria. It is also not clear if the impacts are such that people should be~     preemptively treated before they get vaccinations. Researchers want to see if there is a~     link between taking an antimalaria drug prior to getting vaccines and the immune response to~     those vaccines. To do this, they will study people who are taking part in certain NIAID~     studies.~      Objectives:~      To compare the proportion of PD1+ CD4 T cells among all T cells in vaccine immune responses~     in adults who have or have not received antimalarials prior to getting a Menactra vaccine.~      Eligibility:~      Healthy Malian adults who:~      Were previously enrolled in NIAID Protocol 13-I-N109 or 15-I-0044~      Reside in Bancoumana and neighboring villages~      Are not pregnant~      Design:~      Participants will be screened with a physical exam.~      Participants will get the vaccines listed below as part of Protocol 13-I-N109 or 15-I-0044.~     This study will follow their schedule.~      At each visit, participants will give a blood sample. They will also have a physical exam.~     Each visit will last 1 to 2 hours.~      At visit 1, participants will get a hepatitis vaccine.~      Two weeks later, participants may get the antimalarial drug Coartem . They will be chosen at~     random.~      Two weeks later, participants will get Menactra .~      Participants will have 5 follow-up visits after they get Menactra .~      The study will last up to 4 months.~   "
39195|NCT02544035|"~     Background:~      Play during childhood is an important part of healthy development, and children can learn~     many things when they play. Much of the time that children spend playing is with toys.~     However, children at different ages need different types of toys to engage in healthy play.~      Understanding children s play with toys is important to the National Institute of Child~     Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission~     (CPSC). The CPSC rates toys that are currently available in the United States for children~     for age appropriateness. NICHD will share the findings of this study with CPSC to aid in~     their toy rating process.~      Objective:~      To categorize traditional and contemporary children s products and toys into age appropriate~     groups.~      Eligibility:~      Healthy children 6 months to 12 years old.~      Their parents.~      Design:~      Participants will be screened with a phone call with the parents.~      Participants will complete surveys online or on paper, and by phone. These will ask about~     demographic facts, behavior, thoughts on parenting and toys, and child development.~      Participants will have 1 study visit. The child will play with toys by himself or herself.~     Then they will play with their parent. A researcher will observe. The sessions will be~     videotaped.~      Children will share their thoughts about the toys by pointing at a smiley face scale.~      Parents will fill out a short survey. Then can choose to participate in a 1-hour focus~     group.~   "
39196|NCT02544022|"~     Background:~      People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (PNs) can have pain~     that affects their daily lives. This study aims to improve questionnaires that measure their~     pain, daily living, and physical functioning.~      Objectives:~      To examine and improve questionnaires about daily living for people with NF1 and PNs.~      Eligibility:~      People ages 5 and older with NF1 and a PN~      Design:~      Participants will be screened with medical history.~      This study will have 2 phases.~      Phase 1 participants will talk about existing pain assessment questionnaires and how PNs~     affect their life. They will have group discussions of up to 8 people of a similar age with~     NF1 and PNs, or the parents of children with it. These will last about 90 minutes. Children~     ages 5 to 7 and their parents will have one-on-one meetings instead. These will last about~     45 minutes. Discussions will be audiotaped. After the questionnaires have been changed,~     individual interviews will discuss the new wording, instructions, questions, and electronic~     format of the new forms.~      Phase 1 participants may be invited to Phase 2.~      Phase 2 participants will complete the new questionnaires. These may be pen-and-paper or~     electronic. The questionnaires will take about 30 minutes for adults and teens. Children~     will work one-on-one with a staff member and may need up to 45 minutes. A small group of~     participants will be complete the forms twice in clinic and 1 month later at home. Also, a~     small group who start a new pain treatment or have a dose increase in their treatment will~     complete the forms twice before the treatment change and 1 month later.~   "
39204|NCT02543918|"~     The purpose of this study is to compare the body's immune response when vaccines are given~     alone versus when vaccines are given along with the study drug called ixekizumab. The~     vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with~     follow-up at 12 weeks.~   "
39241|NCT02542384|"~     The study schedule is comprised of a 14-day Screening Period, a treatment period and an~     observation period. All eligible subjects will be randomized into one of 3 treatment groups~     (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously~     prior to surgery, and at specific time intervals post surgery. Additional rescue pain and~     anti-nausea medication will be made available. Post surgical changes in pain intensity,~     nausea and vomiting will be assessed.~   "
39242|NCT02542371|"~     The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single~     photon emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to~     have subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed~     tomography angiography (CCTA).~   "
39197|NCT02544009|"~     Background:~      Many people regain the weight they lose through diet and exercise. This might happen because~     the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may~     cause people to regain weight if they do not keep up high levels of exercise or major~     caloric restrictions. Researchers want to find the long-term effects of metabolic adaptation~     in the previous Biggest Loser study participants. They hope to learn the body s response to~     lifestyle changes that result in weight loss. They also want to see if certain changes can~     lead to longer-term success in maintaining weight loss.~      Objectives:~      To better understand the long-term metabolic changes caused by rapid weight loss achieved~     through diet restriction and vigorous physical activity.~      Eligibility:~      Former Biggest Loser research study participants (Protocol No. PBRC29008).~      Design:~      Participants will be screened with a phone interview.~      This study has 3 phases.~      Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor~     and wireless scale. These will send their daily weight and activity back to NIH.~      In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured~     through:~      Their activity monitor~      Urine samples and daily body weight~      Medical review and physical exam~      Fasting for 12 hours each night for a blood draw the following morning~      DEXA: a low-dose x-ray of the body~      BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.~      Phase 3 will last at least 3 weeks. Participants will:~      Continue to monitor their daily weight and activity~      Collect urine samples and send them back to NIH~   "
39198|NCT02543996|"~     Background:~      Studies show that rare genetic variants might lead to diseases. Researchers want to collect~     blood and tissue samples so they can study them and better understand diseases.~      Objective:~      To collect blood and tissue samples for studies to identify underlying causes of disease.~      Eligibility:~      People of all ages~      Design:~      Participants will have blood and/or tissue samples collected.~      Samples can be collected at the NIH Clinical Center. Participants doctors can collect the~     samples and send them to NIH. NIH staff can collect samples off site.~      For blood samples, blood is taken from an arm vein using a needle.~      Tissue collection may involve:~      Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab.~      Saliva collection: Participants spit into a cup.~      Skin biopsy: A special needle takes a very small skin sample.~      Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that~      would routinely be removed.~      Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a~      small piece of the umbilical cord or blood from the cord once the baby is delivered.~   "
39199|NCT02543983|"~     Background:~      There are no good treatments for people considering suicide. Researchers want to study~     suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better~     understand suicide, so they can help suicidal people.~      Objective:~      To understand what happens in the brain when someone has thought about or attempted suicide.~      Eligibility:~      Group 1: Adults ages 18 70 who have thought about or attempted suicide recently~      Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past~      Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about~     suicide~      Group 4: Healthy volunteers the same ages.~      Design:~      Participants will be screened in another protocol. Adults who have recently thought about or~     attempted suicide must be referred by a doctor. They may do up to 3 phases of this study.~     Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.~      Phase 1: 1 week in hospital. Participants will have:~      Physical exam.~      Questions about thoughts and feelings.~      Thinking and memory tests and simple tasks.~      Blood and urine tests.~      Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes~     pictures. They will have a coil over their head and earplugs and do a computer task.~      Sleep test. Disks and bands will be placed on the body to monitor it during sleep.~      Magnetic detectors on their head while they perform tasks.~      A wrist monitor for activity and sleep.~      Lumbar puncture (optional). A needle will collect fluid from the back.~      Shock experiments (optional). Participants will observe pictures and sounds and feel a small~     shock on the hand.~      Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood~     draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1~     tests.~      Phase 3: up to 4 more ketamine doses over 2 weeks.~      Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5~     years.~   "
39200|NCT02543970|"~     The primary objective of this study is to confirm the safe and effective use of the Celluma3~     for the reduction in the appearance of periorbital wrinkles.~   "
39201|NCT02543957|"~     An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to~     directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted~     into the participants mouth to the participants stomach and into the participants liver to~     visualize the bile duct) that is usually performed in patients for the following purposes :~        1. The removal of all stones from the participants bile duct (if present).~        2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present).~        3. Acquiring tissue sample biopsy from common bile duct narrowing (if present). However~          this procedure is associated with an increase risk of infection compared with the~          standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite~          the administration of antibiotics prior to these procedures, infection still occurs.~          This leads to a suspicion that other factors may be the cause in these infections.~          Factors such as age, race, gender and ethnicity have not been fully explored yet. This~          study aims to examine these factors in addition to others in patients who are~          undergoing ERCP with cholangioscopy as part of their routine medical care. This~          examination will allow us to bring out if any of the above mentioned factors may be~          involved in the development of an infection after ERCP with cholangioscopy.~   "
39202|NCT02543944|"~     Overall, this proposal seeks to improve treatment strategies for the significant public~     health problem of prescription opioid dependence by determining whether gabapentin, a~     non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy,~     will be effective in ameliorating withdrawal symptoms, craving and illicit drug use in~     prescription opioid dependent participants undergoing a 10-day detoxification from~     buprenorphine. In addition, the acceptability and feasibility of transitioning to depot~     naltrexone therapy will also be determined. If successful, this study would provide data to~     support further development of gabapentin as a pharmacological tool for improved outcomes~     during opioid detoxification as well as an integrated outpatient approach for treating~     prescription opioid dependence.~   "
39203|NCT02543931|"~     The purpose of this study is to find out whether turmeric dietary supplements that are~     available over the counter for general use in the United States are safe and useful when~     taken specifically for the treatment of rheumatoid arthritis (RA) and how the active~     principles in turmeric are broken down and metabolized by the body in individuals with RA.~   "
42481|NCT02500940|"~     The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy~     schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in~     patients with advanced nasopharyngeal carcinoma~   "
39205|NCT02543905|"~     Prostate cancer is the most common cancer in men in the United Kingdom (UK) with over 40,000~     men diagnosed each year. Prostate cancer (PrCa) can run in some families and research~     studies have identified several genetic changes that are thought to increase the risk of~     developing prostate cancer. This study aims to look at the potential risk of these changes~     in targeted screening. Some of these changes may cause a very slight increase in prostate~     cancer risk while others may cause a much larger increase in risk of developing prostate~     cancer. The investigators will invite men with a family history of prostate cancer for~     targeted prostate screening (Prostate Specific Antigen (PSA) testing and a biopsy of the~     prostate gland) and genetic profiling. This research will help us to determine what the risk~     of cancer is for men who have inherited these genetic changes and also increase our~     knowledge about the role of genetics in developing prostate cancer targeted screening. Some~     of these changes may cause a very slight increase in prostate cancer risk while others may~     cause a much larger increase in risk of developing prostate cancer.~      The investigators will invite men with a family history of prostate cancer for targeted~     prostate screening (PSA testing and a biopsy of the prostate gland) and genetic profiling.~     This research will help us to determine what the risk of cancer is for men who have~     inherited these genetic changes and also increase our knowledge about the role of genetics~     in developing prostate cancer.~   "
39206|NCT02543892|"~     This study will determine if PATH-wSP, a vaccine against a germ that causes pneumonia, is~     safe and induces immune responses in adults and toddlers. The study vaccine will be compared~     to placebo. First adults will receive a 2 injections of a lower dose of the vaccine or~     placebo, 28 days apart. If the lower dose is safe, then a higher dose will be tested. Once~     the safety is established in adults the lower and higher dose will be tested in toddlers,~     starting with the lower dose.~   "
39207|NCT02543879|"~     This is an open-label, multicenter, dose-escalation Phase 1 study in patients with acute~     leukemia/high-risk MDS or non-Hodgkin Lymphoma, intended to investigate safety,~     pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more~     intermittent dosing schedules. Once the MTD has been established, up to 56 additional~     patients may be enrolled in 4 expansion cohorts in selected patient populations at the~     recommended dose for future studies to confirm safety.~   "
39208|NCT02543866|"~     This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to~     eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae~     in pediatric patients.~      FMT will be performed on subjects with a history of at least one infection due to ESC-R~     Enterobacteriaceae.~      This protocol aims to determine the feasibility, safety, tolerability, and potential~     efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.~   "
39209|NCT02543853|"~     The purpose of this study is to determine effect of veres needle entry and direct trocar~     entry on postoperative gastrointestinal functions.~   "
39210|NCT02543840|"~     This randomized program evaluation is undertaken in conjunction with the Department of~     Veterans Affairs Office of Mental Health Operations and the Quality Enhancement Research~     Initiative. It is designed to answer two related questions: (1) Can an evidence-based~     implementation strategy using the CDC's Replicating Effective Programs plus External~     Facilitation (REP-F)enhance the adoption of team-based care in VA General Mental Health~     Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans'~     health status, satisfaction, and perceptions of care? The model for team-based care is the~     evidence-based Collaborative Chronic Care Model (CCM).~      In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary~     Program team (BHIP) initiative, the investigators have structured a randomized, controlled~     program evaluation to answer these questions. Specifically, using a stepped wedge design the~     investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1~     of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait~     with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures~     will be collected in a repeated measures design at 6-month intervals, and analyzed with~     general linear modeling.~   "
39211|NCT02543827|"~     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine~     (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo~     group.~   "
39212|NCT02543801|"~     This study evaluates two routinely used drug combinations for periarticular injection~     following total hip arthroplasty for pain control. One group will receive liposomal~     bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive~     ropivacaine, clonidine, epinephrine and ketorolac.~   "
39213|NCT02543788|"~     Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that~     may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any~     acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON~     and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage~     could be secondary to retrograde atrophy of axons within plaques of demyelination or a~     primary progressive degeneration of ganglion cells, but the underlying physiopathology has~     not been fully questioned in the different profile types of CON.~      In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON,~     i.e. secondary to demyelination or primary degeneration, in patients complaining of~     persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to~     moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive~     neuro-ophthalmological assessment including clinical examination, visual evoked potentials~     (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT~     (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve.~     In these patients with mild to moderate CON, investigators aim at differentiating patients~     showing predominant demyelination from those showing pure or predominant axonal~     degeneration. Visual function assessment and degree of axonal degeneration will be compared~     and correlated in the two types of underlying pathophysiology and in the group of control~     subject. In a following longitudinal study, the patients will be re-assessed a year later in~     order to evaluate the progression of CON in both profile types. Our hypothesis would be that~     visual function and progression is worse in the degeneration group as compared to the~     demyelination group. This study should help to find reliable measures of the pathophysiology~     of CON and correlate it with the long-term visual prognostic of the disease.~   "
39214|NCT02543775|"~     The primary objective of this study is to determine the feasibility of detecting the~     sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined~     radioisotope and blue dye technique.~      The investigators hypothesize that the sentinel lymph node (first node draining the~     tumour/cervix) for early stage cervical cancer represents the status of the regional lymph~     node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need~     for complete pelvic lymphadenectomy.~   "
39215|NCT02543762|"~     To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted~     biopsies~   "
39216|NCT02543749|"~     The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical~     situation of minimal residual disease. This might be a strategy to immunologically~     eradicate the residual leukemia cells. Patients to be included are chronic phase bcr/abl+~     CML (chronic myeloid leukemia) patients in stable cytogenetic and/or molecular remission.~      These patients can be included if they have:~        1. not achieved a CMR (complete molecular response) or~        2. achieved bcr/abl < 10% on qPCR (quantitative polymerase chain reaction) (=MCyR) (Major~          cytogenic Response), but less than a CCyR (complete cytogenic Response).~      Autologous DC (Dendritic cells), generated under GMP (Good manufacturing conditions)~     conditions, are used as a vaccine. These DC constitutively express all putative tumor~     antigens. In order to ensure sufficient presentation of distinct CML-related antigens,~     particularly in good responders to TKIs, DC are additionally pulsed with peptides from~     bcr/abl, WT-1 (Wilms Tumor Protein) and proteinase-3. Monitoring of T cell reactivity~     against these peptides can then serve as surrogate marker for anti leukemic immunity induced~     by the vaccine. Vaccination is performed with 10^7 DC i.d. (intra dermal) in weeks 1, 3, 5,~     8, 11, 14, 17, 20, 23 and 26. KLH (keyhole limpet hemocyanin) is used as an adjuvant for~     vaccine preparations in weeks 3, 5 and 8 (and 11).~   "
39217|NCT02543736|"~     Knee osteoarthritis (KOA) patients, have impairments in gait and balance. Accurate gait and~     postural balance analysis is needed to detect this impairments. Nevertheless methodological~     quality about the recording of gait and balance analysis in KOA patients is lacking in~     literature.~   "
39218|NCT02543723|"~     Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to~     traditional intravenous chemotherapy, and factors promoting this trend include increased~     survival times requiring long-term therapy, acceptability among patients, convenience, and~     cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients,~     adherence to these medications vary. Suboptimal medication adherence leads to loss of~     treatment efficacy, increased toxicity, and increased health care costs. Thus, it is~     critical to develop and test interventions that effectively improve adherence to OCAs.~     Although the medication adherence literature has been criticized for methodological issues,~     some components of interventions have had promising results on adherence such as electronic~     monitored adherence feedback, cognitive-education, nurse-based interventions, and~     technology-based or telehealth strategies. The investigators propose to unify components of~     these effective approaches in a novel way to assess the efficacy and feasibility of two~     telehealth-based strategies (electronic medication-event monitoring with feedback and~     tailored nurse coaching which includes cognitive-education) in an effort increase OCA~     adherence among cancer patients who are at high-risk for non-adherence in rural eastern~     North Carolina.~   "
39219|NCT02543710|"~     MoMaTEC2 aims to test, in clinically oriented studies, the applicability of already~     identified and promising molecular biomarkers, to promote individualisation of treatment for~     patients with endometrial cancer. Predominantly, but not exclusively, such biomarkers have~     shown to be interesting in retrospective analysis of our large prospectively collected~     MoMaTEC1 series.~      Part 1: Performance of a phase 4 implementation trial for optimised stratification of~     surgical treatment, specifically the performance of (para-aortic and pelvic) lymphadenectomy~     guided by validated biomarkers.~      Part 2: Performance of a phase 2b clinical biomarker study to evaluate the predictive~     potential of the biomarker stathmin for taxane treatment response in endometrial and ovarian~     cancer. In this study stathmin will be used as integrated biomarker.~   "
39220|NCT02543697|"~     Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical~     Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify~     if the overproduction of cortisol is from one adrenal, or from both sides. If it is~     one-sided, the investigators offer the patient operation.~   "
39221|NCT02543684|"~     The aim of the current study was to compare the effects of three ready-to-eat mixed meals,~     with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic~     response in patients with Type 2 diabetes mellitus (T2DM).~   "
39222|NCT02543671|"~     The primary aim of the current study was to investigate whether the consumption of vitamin~     D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum~     25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in~     what degree it can contribute as a potential food-based strategy for the prevention of~     vitamin D deficiency. A secondary aim was also to investigate any potential effect of the~     intervention in several quality of life (QoL) indices in the population of postmenopausal~     women under study.~   "
39223|NCT02543658|"~     Acute pancreatitis with Intra-abdominal Hypertension have high mortality rate,~     intra-abdominal pressure mainly because of intestinal paralysis which due to edema,~     intestinal gas, fluid and other intestinal dysfunction.Neostigmine is an anti-cholinesterase~     drugs, can enhance intestinal peristalsis, promote flatus, defecation. This study will~     determine the efficacy of neostigmine in the treatment of acute pancreatitis with~     Intra-abdominal Hypertension.~   "
39224|NCT02543645|"~     This is a study to determine the clinical benefit (how well the drug works), safety and~     tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll~     patients with a number of tumor types; Phase ll will enroll only patients with renal cell~     carcinoma (RCC).~   "
39225|NCT02543632|"~     Prospective, multi-center, post-market, non-randomized, nested-control, observational study~     of the CE marked CardioKinetix Parachute Implant System.~   "
39226|NCT02543619|"~     Forty healthy patients with including criteria who failed to infra alveolar nerve block~     injection (without lip numbness) have been randomly divided into two groups on a random~     basis and have received Gow-Gates or another inferior alveolar nerve block injection.~     Endodontic access cavity preparation has been initiated after complete anesthesia. If~     patients felt any pain during the steps of caries or dentin removal, Endodontic access~     cavity preparation or canal working length determination, treatment has been stopped and~     their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and~     170 as maximum pain ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.~   "
39227|NCT02543606|"~     Bioequivalence of Two Formulations of Esomeprazole 40mg~   "
40687|NCT02524431|"~     The purpose of this study is to try to identify the cause of damage to the drainage system~     of the eye (the trabecular meshwork). Damage to this system may cause elevation in the~     pressure within the eye and thereby damage to the optic nerve and the vision.~   "
39228|NCT02543593|"~     Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high~     prevalence and important sexual, conjugal and psychological deleterious repercussions,~     effective evidence-based interventions remain limited. For a high proportion of women,~     significant pain persists despite the currently available treatments. Transcranial~     direct-current stimulation (tDCS) was shown to be effective in various chronic pain~     conditions. So far, only one case report study has shown significant pain reduction in women~     with vulvodynia. The main goal of this randomized controlled trial is to evaluate the~     efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by~     a gynecologist following a standardized protocol will be randomized to either active or sham~     tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures~     will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome~     is pain during intercourse assessed with a numerical rating scale (NRS). Secondary~     measurements focus on sexual function, vestibular pain sensitivity, psychological distress,~     treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators~     expect that active tDCS treatment will significantly reduce pain during intercourse~     (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will~     provide important information for determining the efficacy of a novel and promising~     intervention for women with PVD.~   "
39229|NCT02543580|"~     The purpose of this study is to evaluate the effects of single acupoint or two combination~     of acupoints stimulated with electroacupuncture on patients undergoing radical operation of~     breast cancer~   "
39230|NCT02543567|"~     The purpose of this study is to demonstrate the non‐inferiority of a heterologous~     prime‐boost regimen using Ad26.ZEBOV as prime and MVA‐BN‐Filo as boost administered at~     different doses at a 56‐day interval versus the same regimen with the recently released~     batches of Ad26.ZEBOV and MVA‐BN‐Filo in terms of humoral immune response against the Ebola~     virus (EBOV) GP (glycoprotein) as measured by enzyme‐linked immunosorbent assay (ELISA) at~     21 days post boost.~   "
39231|NCT02543554|"~     Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary~     complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in~     the emergency department (ED) has been studied infrequently when compared to the intensive~     care unit; however, data suggests that ED-based mechanical ventilation has significant room~     for improvement and may also be a causative factor in ARDS incidence.~   "
39232|NCT02543541|"~     The goal of this research study is to find out if providing patients who are enrolled in~     phase 1 clinical trials with structured supportive care will enable them to continue in the~     Phase 1 trial longer and improve their quality of life by reducing or treating side effects~     and by providing emotional and social support to the patient and family. The structured~     supportive or palliative care intervention will be provided by a team of trained specialists~     which include doctors, nurses, social workers and spiritual care providers. The supportive~     care team will provide treatment to address symptoms, such as pain or anxiety, caused by the~     cancer itself or from the treatment. The team can make referrals to other specialists. Such~     as psychologists or nutritionist, if needed, and can help arrange for services to address~     home care needs.~   "
39233|NCT02542488|"~     This study evaluates the use of the STOPBANG questionnaire to predict whether an obese~     pregnant woman has obstructive sleep apnoea. All participants will have a STOPBANG score~     calculated and then be tested with overnight oximetry to see if they have obstructive sleep~     apnoea.~   "
39234|NCT02542475|"~     To assess the effects of daily LFMS treatments for those suffering from affective or anxiety~     symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active~     treatment over the period of one week, with improvement through the following week.~   "
39235|NCT02542462|"~     This is a prospective randomized clinical trial that aims to evaluate the potential effects~     of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood~     and stool cytokine responses. It will also assess the association between these outcomes and~     the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be~     randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with~     other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with~     other recommended vaccines. Data derived from the pilot study will be used to assess the~     feasibility of conducting a larger scale study.~   "
39236|NCT02542449|"~     This study evaluates whether supplementations with a highly bioavailable green tea extract~     may help obese women to counteract weight regain after a 3-month weight loss intervention.~   "
39237|NCT02542436|"~     This study will focus on participants in the United Kingdom (UK) to collect local data on~     the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic~     colorectal cancer in normal clinical use.~   "
39238|NCT02542423|"~     According to literature data, Endocan can detect the onset of respiratory failure. The~     investigators aim to prove its value also for cardiac surgery patients.~   "
39239|NCT02542410|"~     The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,~     cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of~     endometriosis-associated pain in young women with endometriosis.~   "
39240|NCT02542397|"~     About half of all cancer patients seen in oncology clinics have pain at initial assessment;~     pain relief within a one-month period is seen in approximately one third of these patients~     and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain~     include age older than 65 years, minority status, and inadequate pain assessment practices.~     There is a need for better methods of opioid drug/dose selection and identification of risk~     factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic~     variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids.~     Translating pharmacogenomic results into actionable prescribing decisions may ultimately~     enable a personalized approach to pain management, increasing the chance of significant pain~     improvement. Cancer outpatients with uncontrolled malignant pain will be offered a~     pharmacogenomic test through participation in the study. The results of this test will be~     used to modify their pain regimen, if applicable.~   "
39755|NCT02536612|"~     The purpose of the study is to test feasibility and acceptability of a lottery to help women~     in Cape Town, South Africa to continue using long-acting reversible contraceptives to avoid~     unintended pregnancies, and to also use condoms to reduce sexually transmitted infections~     including HIV.~   "
39243|NCT02542345|"~     This is a prospective, multicentric study conducted in order to evaluate if MRI~     coronarography is as powerful as Cardiac Multislice CT in detection of coronary~     abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults~     who underwent coronary reimplantation in childhood.~      Newborns suffering from transposition of the great vessels who underwent at neonatal age an~     arterial switch operation (ASO) with coronary reimplantation, may develop in time with~     growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause~     myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous~     coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same~     complications. Functional ischemic tests in a combination of three minimum are positive in~     only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in~     those patients.~      In those patients, coronarography was recommended to be performed at least at 7 and 15 yo,~     without any clinical symptoms . It has also been recommended to examine those patients at 5,~     10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT~     has been proven to be as efficient as coronarography to depict coronary reimplantation~     abnormalities .~      Due to the invasiveness of angiography and to the development of cardiac CT, in our~     institution, the attitude is to performed cardiac CT instead of angiography with the same~     frequency in our patients.~      Coronaro MRI has been established as a valid technique for evaluation of coronary arteries~     in patients after ASO .~      The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as~     Cardiac Multislice CT for the depiction of coronary anomalies.~      All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and~     eligible for MRI, over 5yo are included in this prospective multi centric study.~      Both examinations are performed on the same day after informed consent, from the patient or~     from both parents if minor.~      Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro~     angiography is performed as follow: excluding any contra indication to MR, the study~     requires one or two maximum 3D true FISP sequence without IV contrast injection, with~     cardiac gating, and free breathing.~      3D images are evaluated blinded to the results of cardiac CT by two senior radiologists,~     with at least 5 years of experience in MR and CT cardiac imaging.~      Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance~     and feasibility of the examination.~      The study is designed for four years and benefits from a grant from the Assistance~     Publique-Hopitaux de Paris.~   "
39244|NCT02542332|"~     This study evaluates whether doctors are familiar with the statistical background of lung~     cancer screening.~   "
39245|NCT02542319|"~     Randomized placebo-controlled double-blinded interventional trial to investigate the effect~     of oral magnesium supplementation on vascular calcification in subjects with chronic kidney~     disease. We hypothesize that oral magnesium supplementation will reduce vascular~     calcification in subjects with chronic kidney disease while not decreasing bone mineral~     density.~   "
39246|NCT02542306|"~     Bleeding is a common complication of cardiac surgery, especially aortic arch surgery~     involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly~     used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and~     safety are unknown.~      Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below~     1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the~     non-FC-treated group.~   "
39247|NCT02542293|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of MEDI4736 + tremelimumab combination therapy versus platinum-based SoC~     chemotherapy in the first-line treatment of patients with epidermal growth factor receptor~     (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.~   "
39248|NCT02542280|"~     The investigator suggests that local endometrial injury using pipelle catheter performed in~     the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the~     pregnancy rates among patients undergoing intrauterine insemination.~   "
39249|NCT02543515|"~     Study type:~      Observational, prospective.~      Objectives:~      Primary:~      Identify psychosocial and clinical factors that predispose to the occurrence of pain~     following office hysteroscopy~      Secondary:~      Stratify risk factors for pain previous Cesarean section and pain score repeat C section and~     pain score post-menopausal and pain score type of delivery and pain score body mass index~     and pain score history of dysmenorrhea and pain score, abnormal uterine bleeding and pain~     score previous surgery upon uterine cervix and pain score Characterize women's psychosocial~     profile and pain score Establish anxiety as a factor influencing pain perception using~     (State-Trait Anxiety Inventory for Adults).~      Determine if there is a specified population who would benefit from procedure under~     anaesthesia~   "
39250|NCT02543502|"~     The main objective of this study is to evaluate the effect of treatment periodontal~     endothelium-dependent artery of the arm in patients with acute myocardial infarction with~     ST-segment elevation undergoing primary coronary intervention.~   "
39251|NCT02543489|"~     The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod~     and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the~     incidence of overhung with Flex IM rod.~   "
39252|NCT02543476|"~     This is a retrospective international, multi-center, non-interventional cohort study based~     on use of data derived from established medical records and secondary analysis of archival~     tumor samples. The study will collect data on patient and tumor characteristics, PD-L1~     status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with~     recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases~     falling into specific ICD-10 or International Classification of Diseases, Ninth Revision~     (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor.~      For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as~     the index date. The patient selection period extends from the 1st March 2011 to the 30th~     June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5~     years age, and ensures approximately 10 months follow-up for living patients recruited at~     last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC~     of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth),~     oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in~     the study (Figure 1). Patients will be identified and followed up through their medical~     records until death or end of data collection in approximately 20 centers in the US, Asia~     and Europe.~      Patients' demographic, clinical characteristics, and medical history will be described.~     Clinical outcomes including PFS, best response, duration of response, and ORR will be~     described for the first line and second line of therapy (if any), and OS will be collected A~     mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has~     more than one suitable tissue sample, the most recent sample will be used as the mandatory~     tissue sample. Where available, additional tumor samples obtained at any other time points~     of the disease will be also collected (optional).~      The enrolment target is up to 600 patients. Statistical analyses will be performed for the~     whole cohort, per PD-L1 status and for predefined subgroups.~   "
39253|NCT02543463|"~     The purpose of this study is to compare the effect of the large head in THA with a~     navigation system and without a navigation system.~   "
39254|NCT02543450|"~     In hemiplegic stroke patients, gait performance is affected by impaired walking endurance.~     Evidence has shown that higher exercise intensity improves cardiovascular fitness, while~     greater dose in task repetition benefits locomotor function. Therefore, the goal of this~     study is to examine the effect of a combined cardiovascular/task-oriented interval training~     programme on the walking capacity of chronic stroke individuals and the improvement in their~     participation.~   "
39255|NCT02543437|"~     The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger~     diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance~     for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the~     Stryker computerized tomography (CT) based Navigation system. Another aspect of this study~     is to observe wear resistance performance of X3 over historical liner existing highly~     crosslinked polyethylene.~   "
39256|NCT02543424|"~     Neurological pathologies cause important and permanent disabilities in every day life. These~     pathologies can follow stoke, affecting two people per one thousand each year or cerebral~     palsy, affecting two births per one thousand each year. To date, the diagnosis and the~     rehabilitation of motor and cognitive problems has been carried out separately by different~     domains. For example, physiotherapists have focused on motor problems and neuropsychologists~     have focused on cognitive functions. However, a number of studies have demonstrated a link~     between motor and cognitive abilities in adults and children. The present study has three~     main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients~     (all ages), (2) to understand the link between motor and cognitive abilities in patients and~     healthy participants and, (3) to propose new types of therapies based on the link between~     motor and cognitive functions.~   "
39257|NCT02543411|"~     The primary purpose of this study is to investigate the effects of lidocaine on the total~     administered dose of fentanyl during sedation for endoscopic mucosal resection.~      The secondary purpose of this study is to investigate the effects of lidocaine on pain score~     related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after~     procedure.~   "
39258|NCT02543398|"~     Following tooth extraction ridge preservation procedure have been suggested to limit bone~     resorptive dimensional changes to facilitate prospective implant placement. While this is~     particularly true for anterior teeth, no evidence is available to establish clinical~     guidelines in posterior sites, i.e. following molar extraction.~      This research project will answer the following question:~      What are the dimensional changes of the hard and soft tissues encountered following molar~     extractions with and without ridge preservation?~   "
39259|NCT02543385|"~     This study investigates the effect of low dose S+ketamine compared to placebo on cumulative~     morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with~     remifentanil-propofol target controlled infusion. It compares the adverse effect profile in~     patients receiving S+ketamine as compared to those who did not. Participants are randomly~     distributed in two groups of 45 patient's each.~   "
39260|NCT02543372|"~     Background: Problem gambling is a public health concern with prevalence rates at 2 %.~     Problem gambling also severely affects concerned significant others (CSOs). Several studies~     have investigated the effects of individual treatments based on cognitive behavior therapy~     (CBT), but there is a shortage in studies on the effect of involving CSOs in treatment. This~     study aims to compare an intervention based on behavioral couples therapy (BCT) involving a~     CSO with an individual CBT treatment to determine their relative efficacy. BCT has shown~     promising results in working with substance abuse, but this is the first time it is used as~     an intervention for problem gambling. Both interventions will be Internet-delivered and~     participants will receive e-mail and telephone support.~      Method/Design: A sample of at least 100 couples will be randomized to either the BCT~     condition or the CBT condition. The participants will work through 10 modules over 12 weeks~     in a secure online environment, and receive support via email and over telephone. Repeated~     measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome~     measure is gambling behavior, defined as time spent and money lost on gambling, as measured~     by timeline follow-back. Secondary outcomes include gambling related harm, alcohol~     consumption, relationship satisfaction and mental health for the gambler as well as for the~     CSO.~      Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on~     gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT~     will be superior to CBT on increasing relationship satisfaction, d) relationship functioning~     will mediate change in gambling behavior in the BCT group and e) reduction in gambling~     behavior will mediate change in relationship functioning in the CBT group.~   "
39261|NCT02543359|"~     Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders (~     DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help~     children and families, they have primarily remained in university settings. Recognized field~     leaders have expressed concern over the discrepancy between treatment research and clinical~     practice, and have indicated that EBT implementation is a priority. Little empirical~     evidence exists regarding how effective commonly used training models are in changing~     clinician behavior, achieving full implementation (e.g., increasing treatment fidelity,~     integrating into service settings), and supporting positive client outcomes. This novel~     application will evaluate the effectiveness of three training models (Learning~     Collaborative, Train-the-Trainer, and Web-Supported Self-Study) to implement a~     well-established EBT in real-world, community settings.~      To accomplish this goal, the project will be guided by three specific aims:~        1. to build knowledge about training outcomes,~        2. to build knowledge about implementation outcomes, and~        3. to understand the impact of training clinicians using LC, TTT, and SS models on key~          client outcomes.~      Seventy-two of 243 possible (30%) licensed psychiatric clinics across Pennsylvania will be~     randomized to one of three training conditions:~        1. Learning Collaborative (LC),~        2. Train-the-Trainer (TTT), or~        3. Web-Supported Self-Study (SS).~      Data also will be collected on staff trained by clinicians in the TTT group given that the~     intention of a TTT model is for participants of that group to return to their organization~     and train others within the organization. The impact of training (clinician level) will be~     evaluated at 4 time-points coinciding with the training schedule: baseline, 6, 12, and~     24-months. Immediately after training begins, parent-child dyads (client level) will be~     recruited from the caseloads of participating clinicians (N = 288). Client outcomes will be~     assessed at four timepoints (pre-treatment, 3, 6, and 12-months). Implementation outcomes~     (clinic level) will be assessed at baseline, 6, 12, and 24-months after training. This~     proposal builds on an ongoing state-led initiative to implement, and ultimately sustain,~     PCIT statewide. Lessons learned from this project will directly impact future EBT~     implementation efforts in Pennsylvania and other states, helping to increase the use of EBTs~     in community settings nationwide.~   "
39262|NCT02543346|"~     Allergen challenge facilities have been utilized for many years in clinical drug trials~     studying onset of action, proof of concept, duration of action, and efficacy. Each facility~     has somewhat different design characteristics and pollen dispersal technologies. Facilities~     are located in disparate geographic areas and have populations of participants who are~     sensitized to allergens unique to that area. Therefore, facilities have operated as single~     sites with little effort to evaluate facility comparability or to attempt standardization~     across facilities. The purpose of this study is to compare the two sites and assess whether~     the sites are able to achieve similar symptom scores.~   "
39263|NCT02543333|"~     Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients~     with acute asthma; an observational study in healthy participants and during patients'~     clinical investigation of broncho-reversibility in the asthma groups.~   "
39264|NCT02543320|"~     The goal of this study is to learn how the brain processes pain and if using neurofeedback~     training can help teach patients ways to modify their own brain waves to decrease the~     perception of pain and improve quality of life.~   "
42482|NCT02500927|"~     The purpose of this study is to determine the safety, the antitumor activity and the~     pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with~     non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.~   "
39265|NCT02543307|"~     Objectives: This quasi-experimental pre-post-study investigated the effect of newly~     developed Nurse-led Patient Pathways (NPP) designed to improve patients`, and health care~     professionals` as well as institutional outcomes.~      Intervention: In the IG patients were cared for under the three newly developed NPP. NPP are~     characterized by four principles: evidence-based nursing, patient and family centered care,~     comprehensive discharge planning beyond hospital discharge and nurses' responsibility for~     patients` processes. The principles support and strengthen patient and family preferences as~     well as formalize nursing activities, and therefore contribute to process transparency in~     relation to other health care professionals.~      Outcomes: Primary Outcomes were defined as quality of nursing care (nursing care index,~     NCI), and patient satisfaction (patient satisfaction with nursing care quality, PSNCQ).~     Secondary outcomes were defined as 1) nursing work environment (nursing work index revised,~     NWI-R; and nursing workplace quality, NWQ), and 2) institutional-related costs (length of~     hospital stay, LOS; nursing time and nursing costs). Additionally, nurses` and other health~     care professionals` experiences of intervention translation will be explored.~   "
39266|NCT02543294|"~     The goal of this clinical trial is to learn if heart function remains normal after stopping~     heart failure medication in patients who have received chemotherapy.~   "
39267|NCT02543281|"~     The purpose of this study is to better understand how adaptive cardiac resynchronization~     therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only~     the left side of the heart, rather than to both sides, depending on how it senses the heart~     is functioning. CRT without the adaptive algorithm works by giving stimulation to both sides~     of the heart. aCRT has already been approved by the FDA and is being used in patients now,~     but it is not clear which patients it should be used in compared to normal CRT. This study~     will include patients who are already scheduled to get a CRT device. The investigators will~     then randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the~     investigators will assess the electrical activity of the patients' hearts. After this time,~     the patient and their doctors will be able to decide if they would like to change the type~     CRT they have been designated.~   "
39268|NCT02543268|"~     The purpose of this study is to compare the humoral immune response induced by 3 different~     batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the~     Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.~   "
39269|NCT02543255|"~     This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone~     acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in~     patients with high-risk prostate carcinoma. Half of the participants will receive treatment~     with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will~     receive only abiraterone acetate, prednisone, and leuprolide.~   "
39270|NCT02543242|"~     The rationale for the conduct of this study is that the Intone device (along with pelvic~     physiotherapy) can be used to help females suffering from urinary stress incontinence by~     using electrical stimulation and biofeedback during pelvic floor muscle training. This~     investigation is important because it can aid in the greater acceptance and development of~     non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The~     study results will address if the Intone device is beneficial and promotes long-term~     improvement in women that suffer from urinary incontinence.~   "
39271|NCT02543229|"~     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK)~     and pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months~     with and without Lucentis™ in patients with wet age related macular degeneration (AMD). This~     study will be conducted in two parts: Part 1 will comprise an open label, sequential dose~     escalation and Part 2 a randomized dose expansion.~      OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human~     vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It~     functions by binding and neutralizing the activity of vascular endothelial growth factor~     (VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3.~      VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating~     VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage.~     Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet~     AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or~     VEGF-D which are alternate members of the same family of molecules.~      VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as~     VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via~     VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important~     role in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™.~      Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of~     the VEGF family. This strategy targets functional redundancy in the VEGF pathway and~     mechanisms of 'resistance' or sub-response to VEGF-A inhibition.~   "
39272|NCT02543216|"~     Interactions between genes and environment, are likely to be crucial in the development of~     the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2~     genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid~     profile.The aim of this study is to test if subjects with the CC and TT genotypes of the~     FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid~     (substrate for FADS). We hypothesize that subjects with the TT genotype with more active~     desaturases will be more sensitive to dietary modification leading to more robust~     differences in serum FA profile, tissue inflammation and serum lipids.~   "
39273|NCT02543203|"~     Essential oils (aromatic oils extracted from plant parts) are routinely used by the public~     and are available on the market. Investigators are conducting this study because it is~     unknown whether the essential oils formulations will be safe and effective for improving~     quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and~     sleep.~      Children invited to participate in this study must be between 3-9 years of age and have been~     diagnosed with Autism Spectrum Disorder. Approximately 34 children and their families will~     be enrolled in the study.~      Participants will try two different fragrant oils in a double-blind randomized order. Each~     child will receive each treatment for 3 months, with a 1-month washout period in between~     during which no oil is used.~   "
39274|NCT02543190|"~     Short-term post-operative complications after colon and rectal surgery present a known major~     clinical and financial burden for patients and hospitals. Focused efforts to reduce~     readmissions after colorectal surgery is one potentially high-yield and broad approach to~     address this problem since post- operative complications are the strongest predictor of~     readmissions. We focus on decreasing readmissions after ileostomy surgery by using a~     previously published intervention that prevents dehydration in the outpatient setting and~     decreases acute renal failure complications. We plan to introduce the SWIFT post op program~     for ileostomy patients at one academic and two community hospitals which are part of a~     single health care system, and to then randomize patients to usual care in the setting of~     this new program versus an aggressive compliance surveillance and improvement strategy~     (CSIS) strategy using study personnel. Our primary study outcome is all-cause 30-day~     readmission, and our secondary outcomes include patient satisfaction (CAHPS scores) and a~     cost-benefit analysis. We seek to create a partnership between colorectal surgeons,~     inpatient nurse managers and wound ostomy continence nurses (WOCN) at the three sites,~     linking them with outpatient nurse practitioners and physician's assistants at the~     respective colorectal surgery clinics who facilitate care-transition after hospital~     discharge.~   "
39275|NCT02543177|"~     Aim of the study is the determination of the ideal timepoint for the treatment of patients~     with acute Non-ST-segment Elevation Myocardial Infarction (NSTEMI) and an acute or chronic~     kidney disease (CKD) with a GRACE score < 140. It should be determine if a prompt coronary~     angiography or the protection of the kidneys from the used contrast agent is more important~     for the outcome of the patients. Additionally it will be investigated if the ischemic~     precondition can help to prevent heart damages.~   "
39276|NCT02543164|"~     Objective of the study is to investigate the influence of beta-glucan enriched barley flour~     as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic~     response will be measured as AUC of blood glucose after consumption of barley bread(s), and~     compared with white bread.~   "
39277|NCT02543151|"~     The purpose of this study is to describe SpyGlass choledochoscopy in patients with post~     orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal~     changes after treatment stents.~   "
39278|NCT02543138|"~     Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy~     process that is difficult for unskilled physicians, whereas the use of a traditional trocar~     is relatively likely to damage internal organs. In this study, investigators developed a new~     trocar and examined its usefulness.~   "
39279|NCT02543125|"~     To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV)~     in preterms with respiratory disease syndrome(RDS) after extubation.~   "
39280|NCT02543112|"~     This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab,~     until it is commercially available, to eligible subjects with severe asthma who participated~     in a GSK-sponsored mepolizumab clinical study 200862 and 200363. Eligible subjects will~     initiate mepolizumab within a 6-month period following the individual subject's last~     scheduled visit in their preceding clinical study. For each subject benefit versus risk will~     be assessed throughout the study to support continued treatment with mepolizumab.~   "
39281|NCT02543099|"~     The purpose of this study is to assess the clinical efficacy and safety of policosanol on~     elderly patients with endothelial dysfunction~   "
39282|NCT02543086|"~     This is a single-center open label study conducted in multiple sequential cohorts using~     Induced Blood Stage Malaria infection in healthy volunteers to characterize the~     effectiveness of KAE609 against sexual and asexual blood stage forms of Plasmodium~     falciparum. This study is divided in 2 parts (Part A and part B). A total of 8 healthy~     volunteers per cohort will be enrolled. Based on the results of Part A, Part B will be~     undertaken to evaluate the effect of KAE609 following pretreatment with Piperaquine on~     sexual stage/gametocytemia and its activity as an inhibitor of onward transmission to~     mosquito vectors using experimental mosquito feeding assays.~   "
39283|NCT02543073|"~     Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic~     hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality.~     At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the~     efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as~     the treatment of ILD will be evaluated in the recipients of allo-HSCT.~   "
39284|NCT02543060|"~     This study will evaluate the sensitivity of an assay and its ability to split a marketed~     stannous fluoride toothpaste versus a negative control.~   "
39285|NCT02543047|"~     Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical~     Support for Vein Grafts Used in CABG Surgery.~   "
39286|NCT02543034|"~     This study is a randomized, controlled, multi-centre, open-label, phase IV study.~      Total 81 patients will be enrolled in this study. Patients will be randomly assigned to~     Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.~   "
39301|NCT02542839|"~     Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently~     reported as a source of disability, decreased quality of life, and social stigma. Botulinum~     toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from~     BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure~     symptomatic benefits and does not seem to modify the disease pathophysiology.~      The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as~     an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.~     The primary goal of this study is to compare standard treatment with BoNT versus BoNT~     combined with a two week course of rTMS.~   "
39302|NCT02542826|"~     This is a multi-site collaborative study that will be done in the context of three Quebec~     hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute;~     University of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First,~     to determine the Minimal Clinical Important Difference in intensity ratings of perceived~     breathlessness for each of the 3-min constant rate shuttle walking (3-MWT) and stair~     stepping (3-MST) protocols in patients with chronic obstructive pulmonary disease (COPD).~     Second, to test the hypothesis that both the 3-MWT and 3-MST protocols are able to detect~     statistically significant and clinically-meaningful improvements in exertional~     breathlessness following an 7-12 week outpatient rehabilitative exercise training program in~     COPD.~   "
39287|NCT02543021|"~     Patients with colitis require regular 'surveillance' colonoscopy as their risk of developing~     colon cancer is at least 2.5 times that of the general population. However, cancer in~     colitis develops as flat lesions called dysplasia, that can be easily missed at routine~     colonoscopy. As a result NICE guidelines for colitis surveillance recommend the use of a~     technique called chromoendoscopy (CE) in which a water-soluble blue dye is sprayed through~     the colonoscope to coat and highlight the lining of the bowel, making dysplasia easier to~     see. Although CE is accepted as best practice for surveillance it is time-consuming,~     technically difficult and requires expertise to interpret the appearances. For these~     reasons, its use is not widespread and the vast majority of patients still receive the~     inferior 'routine' colonoscopy without CE.~      New technology means that the video image obtained during colonoscopy can be digitally~     enhanced and coloured at the press of a button - termed virtual chromoendoscopy (VCE). This~     could make surveillance colonoscopy shorter, more comfortable and cleaner (resulting in a~     more 'dignified' experience) as well as cheaper and less technically difficult.~      The main objectives to be explored in this feasibility study (and the larger trial) were~     informed by a PPI meeting, which placed the ability to detect dysplasia at equal importance~     with the participant's experience of the procedure in terms of speed, comfort and dignity.~      This is primarily a feasibility study to assess patient experience, recruitment and~     retention rates to the investigators' specified trial design, to support the development of~     a larger crossover trial to compare VCE to CE during surveillance colonoscopy for colitis.~   "
39288|NCT02543008|"~     Comparison of the effects of physical activity (treadmill running) plus thoracic~     mobilization, physical activity only or a placebo intervention (only manual contact thoracic~     mobilization), on heart rate variability and pressure pain threshold.~   "
39289|NCT02542995|"~     The health of the public depends upon smoothly functioning physician offices that promote~     the health of both workers and their patients. This study targets ambulatory health care~     offices with rapid paced, chaotic environments. Investigators will measure adverse outcomes~     for providers and staff (e.g., stress and burnout), the impact these have on quality of care~     for hypertensive, diabetic and depressed patients, and identify areas where practice~     redesign to create healthy workplaces improves these outcomes.~   "
39290|NCT02542982|"~     This study investigated the combined effects of anodal tDCS and intensive motor training~     (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance~     and functional use of the affected arm in population of chronic stroke patients.~   "
39291|NCT02542969|"~     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of~     rosuvastatin and/or simvastatin in healthy male subjects and female subjects not of~     child-bearing potential.~   "
39292|NCT02542956|"~     The purpose of this study is to identify the best pain management for patients undergoing~     abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM)~     flap for breast reconstruction. The investigator is conducting this study to compare the~     effectiveness of a continuous infusion pain pump versus a locally injectable long-acting~     anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for~     post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug~     Administration) for the purpose of pain control after surgery, and have been used for this~     purpose before.~   "
39293|NCT02542943|"~     This study will investigate the longitudinal efficacy of two experimental oral rinses~     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH~     4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a~     placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride~     toothpaste.~   "
39294|NCT02542930|"~     Patients with Non-small cell lung cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung~          cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic Non-small cell~          lung cancer patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic Non-small cell lung cancer.~   "
39295|NCT02542917|"~     This trial will test, in a representative group of IBD patients, the acceptability of - and~     adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of~     inflammatory bowel disease (IBD)).~   "
39296|NCT02542904|"~     Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric~     resection group and local mesenteric resection group.~   "
39297|NCT02542891|"~     To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural~     Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU).~     Within the French context the TAU is considered as the traditional face to face CBT.~   "
39298|NCT02542878|"~     This study evaluate the effect of the a low back self-application of myofascial release~     using a foam rolling on back muscles endurance measured by the Biering-Sorensen test.~   "
39299|NCT02542865|"~     This will be a single centre, multiple sites, open label, two-arm, parallel-group,~     stratified by gender, matched pair cluster randomized, controlled study. This study will~     test the hypothesis that a fortified malt based food may improve immunity outcomes in 7-10~     year old school age children~   "
39300|NCT02542852|"~     Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of~     atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of~     virological failure in HIV-1 infected patients.~      The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen~     of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of~     virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.~   "
39312|NCT02542696|"~     A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD~     patients with motor fluctuations (OFF episodes), designed to evaluate the long-term~     safety, tolerability and efficacy of APL-130277.~   "
39303|NCT02542813|"~     Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum~     haemorrhage (PPH). However, in resource-poor settings within the developing world, the~     stability and therefore effectiveness of prophylactic IM oxytocin is diminished by a lack of~     appropriate refrigeration facilities and availability of trained health care professionals~     (HCPs) to administer IM injections. This study will be the first investigation of oxytocin~     in humans via the inhaled (IH) route and is designed to evaluate the safety and tolerability~     of inhaled oxytocin and the five non-pharmacologically active components in the placebo, and~     to establish the PK characteristics of up to four fixed escalating doses of inhaled~     oxytocin. In this single blind ascending dose-escalation study, the systemic exposure from~     up to four proposed escalating inhaled fixed-dose levels (50 micrograms [mcg], 200 mcg, 400~     mcg and 600 mcg) will be compared with the systemic exposure following 10 international~     units (IU) of IM oxytocin in healthy premenopausal females.. A total of 15 subjects will be~     enrolled after screening sufficient number of healthy female subjects and the subjects will~     be assigned to one of the two treatment sequences. The total duration of this study is~     approximately 20 weeks.~   "
39304|NCT02542800|"~     Schemas describe mental structures storing recurrent and organized pattern of information.~     Schemas may have a strong influence on the process of storing and retrieving new information~     into memory. Previous approaches in the cognitive neuroscience of memory have entirely~     focused on the individual dimension of preexisting schemas. In the real world though, much~     of the researchers' experiences and knowledge are collective or shared. Such social-cultural~     frameworks stored in collective memory may also reshape and reconfigure the construction of~     individual memories. Attempting to ascertain the influence of collective schema on the~     neural substrates of individual memories using cutting-edge brain imaging methods represents~     the challenge that MULTIBRAIN2 seeks to tackle. To achieve this goal, the researchers will~     record brain activity during MRI scanning sessions in a group of 24 participants while they~     are performing an encoding followed by episodic memory retrieval tasks on pictures of the~     World War II Memorial of Caen. This study will seek to identify brain areas of the~     prefrontal cortex encoding the organization of knowledge in collective memory using~     multivariate analyses of brain activity patterns, and then to understand how such regions~     might modulate the recruitment of the hippocampus during episodic memory retrieval using~     analyses of effective connectivity. The organization of knowledge in collective memory is~     measured in parallel through 1) the analysis of French social memory of World War II using a~     corpus of thousand of television and radio shows from the National Institute of Audiovisual,~     and 2) an internet task measuring the organization of shared individual knowledge about~     World War II. Once collected, these data will help us to understand how collective schemas~     may shape the organization of individual memories.~   "
39305|NCT02542787|"~     Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.~   "
39306|NCT02542774|"~     To evaluate the risk of cardiovascular events associated with medication use for controlling~     blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated~     in primary care~   "
39307|NCT02542761|"~     The purpose of this study is to compare the functional performance of individuals with~     transtibial amputation using two types of prosthetic foot designs: carbon fiber vs.~     fiberglass composite.~   "
39308|NCT02542748|"~     Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be~     used to treat hypotension but lead to lower fetal pH as well. This study is to compare the~     effects of norepinephrine and ephedrine on hypotension in parturients.~   "
39309|NCT02542735|"~     Primary Objectives: To determine the incidence of type 2 diabetes in the south zone of the~     di@bet.es study (Andalusia and the Canary Islands) at 6 years follow-up. To determine the~     main risk factors associated with the incidence of type 2 diabetes and to check the role of~     diet and physical inactivity. To determine whether the interaction between diet fatty acids~     with the genetic variability of the fatty acid transport systems regulated by VEGFB~     influence the risk of diabetes and related diseases. To test in a general population the~     predictive value of some of the risk scores currently available: Finrisc, PREDIMED-clinical~     Score, etc..~      Secondary Objectives: To determine the incidence of obesity and metabolic syndrome in the~     south zone of the di@bet.es study. To determine the main risk factors associated with the~     incidence of obesity and metabolic syndrome: to check the role of diet, physical inactivity~     and certain polymorphisms in genes related to the handling of fatty acids Methodology:~     Prospective population-based cohort study where the incidence of type 2 diabetes, obesity~     and metabolic syndrome at 6 years follow-up will be determined in the sampling south zone of~     the di@bet.es study (1600 subjects aged 18 years baseline data from a randomized cluster~     sampling). Considering follow up losses in 25%, statistical power to detect as significant a~     relative risk of 1.5 (incidence = 10/1000 person-years) is greater than 85% (alpha = 0.05).~     Risk factor / exposure: alterations in glucose estimated from the baseline surveys, the~     presence of insulin-resistance (HOMA) score Finrisk / PREDIMED-clinical Score / adherence to~     Mediterranean diet transport and metabolism of fatty acids and genotypes of genes involved~     in the handling of fatty acids. Covariates: all collected in the baseline study.~   "
39310|NCT02542722|"~     It will be selected 1274 subject older than 40 years of the population of Cabra in order to~     realize a sociodemographic and habits (toxic, food, of physical activity) survey. It will be~     realized a physical exploration including anthropometry, blood pressure, oral glucose~     tolerance test, blood extractions (basal and after 120 ' of the OGTT). Several biochemical~     determinations will be realized (p.e. marker of fat intake and marker of inflammation) The~     proposed intervention consists of a series of clinical visits and phone calls programmed~     with the aim to change the dietetic and physical activity habits of people. The Pizarra~     study (financed with other grants and realised with the same methodology) will be use as~     cohort control. Though the basic aim of the project is to achieve a reduction of the of~     diabetes incidence with a hygienic - sanitary intervention, the ambition of knowing the~     major number of possible factors that can participate in this process constitutes a complex~     project capable of analyzing the problem from diverse points of view. Endocrinologists (of~     two Andalusian hospitals), clinical biochemists, geneticists and dietitians they join in~     this project to approach an integral way the etiopathogeny of the diabetes type 2.~   "
39311|NCT02542709|"~     The purpose of this trial is to study the effect of noninvasive brain stimulation in adults~     with post-traumatic stress disorder.~   "
39313|NCT02542683|"~     1. Compare physical activity and cognitive functions between children having cardiac~          surgery with an age-matched group of children undergoing non-cardiac surgery, as well~          as otherwise healthy siblings or best buddies (or age and gender-matched children if no~          siblings or best buddies available) before surgery and after surgery or six months~          following initial assessment.~        2. Determine the effects of a structured physical activity program for 6 months following~          surgery on cognitive functions and adaptive behavior in children following congenital~          cardiac surgery.~        3. Determine the effects of a structured physical activity program for 12 months following~          surgery on cognitive functions and adaptive behavior in children following congenital~          cardiac surgery.~        4. We will perform exploratory analysis to determine whether any effects of a 12-months~          structured physical activity program on cognitive functions and adaptive behavior~          persist beyond 12 months after cessation of the program.~   "
39314|NCT02542670|"~     Colorectal cancers (CRC) are the third most common human malignancy, and are also the~     leading cause of cancer related deaths worldwide. Early detection of premalignant lesions~     such as adenomatous polyps has decreased the risk of CRCs; however, cases which are~     initially undetected and progress to advanced CRC with distant metastasis are still~     unfortunately incurable. The development of CRC is a complex and heterogeneous process~     arising from an interaction between multiple etiological factors, including genetic factors~     and environmental factors such as diet and lifestyle. The challenges are to understand the~     molecular basis of individual susceptibility to colorectal cancer and to determine factors~     that initiate the development of the tumor, drive its progression, and determine its~     responsiveness or resistance to antitumor agents. Next generation sequencing(NGS)-driven~     genomic studies are already reporting novel features of cancer genomes beyond the~     traditional mutational categories. Recent advance in sequencing technology has enabled~     comprehensive profiling of genetic alterations in CRC.These methods are facilitating an~     increase in the efficiency and resolution of detection of each of the principal types of~     somatic cancer genome alterations, including nucleotide substitutions, small insertions and~     deletions, copy number alterations, chromosomal rearrangements,DNA methylation sequencing~     such as bisulfite-sequencing and microbial infections. Besides the microsatellite~     instability (MSI), some researchers reported novel mitochondrial mutations in the cancer~     genomes. NGS technology will help the investigators for understanding of entire CRC genomes~     and the obtained knowledge will lead to a better diagnosis and personalized targeted~     therapeutics for CRC management~   "
39315|NCT02542657|"~     This phase I/II trial studies the side effects and best dose of clarithromycin when given~     together with ixazomib citrate, pomalidomide, and dexamethasone and to see how well it works~     in treating patients with multiple myeloma that has not responded to previous treatment.~     Biological therapies, such as clarithromycin, pomalidomide, and dexamethasone, use~     substances made from living organisms that may stimulate the immune system in different ways~     and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving clarithromycin with ixazomib~     citrate, pomalidomide and dexamethasone may be a better treatment for patients with multiple~     myeloma.~   "
39316|NCT02542644|"~     Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the~     loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular~     matrix in the form of guttae. This result in failure of the endothelium to support corneal~     deturgescence leading to corneal edema. Affected patients complain about blurred vision at~     early stages of the disease which can progress to blindness. The pathophysiology of the~     disease is still unclear, but several studies point towards a genetic susceptibility.~     Additional risk factors that have been identified are female sex, smoking and older age.~      While for a long time penetrating keratoplasty (PKP) was the only therapy available for~     affected patients, in the recent years less invasive methods such as descemet's membrane~     endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane~     and the endothelium is removed and replaced with the corresponding parts from a donor's~     cornea. For FECD, this brings the advantage that only the diseased part of the cornea is~     replaced. Graft detachment has been identified as the main complication following DMEK.~      In the investigators' study, an ultra high resolution OCT system will be used to detect~     graft detachment in patients with FECD after DMEK. With this technique, even small~     detachments can be visualized. The area of graft detachment will be evaluated at predefined~     time points after surgery and correlated to visual acuity. A follow-up of one year will be~     performed in order to investigate the predictive value of graft adherence status at several~     time points for visual outcome.~   "
39317|NCT02542631|"~     To compare glycemic control and treatment satisfaction using a novel bolus insulin patch~     (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with~     T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.~   "
39318|NCT02542618|"~     Background: Major depression is a common mental disorder with serious consequences. The~     societal costs of depression are high. Despite the existence of empirically-supported~     psychological therapies, many patients do not benefit from these treatments and relapse and~     recurrence percentages are high. Improvement of existing treatments or development of new~     and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising~     verbal therapy focusing on the inquiry of thoughts and could be a next step in improving~     psychotherapy for depression.~      Objective: The objective of the current study is to assess the effectiveness of IBSR.~     Research to date has shown that IBSR is effective in reducing symptoms of anxiety and~     depression. The investigators want to know if IBSR is more effective in reducing symptoms of~     depression than the best psychotherapeutic treatment for depression at this moment,~     cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more~     about the underlying mechanisms of change of these therapies.~      Study design: A randomized controlled intervention study.~      Study population: 88 patients with a mild to moderate depression as their principal~     diagnosis.~      Intervention: IBSR or CBT~   "
39319|NCT02542605|"~     Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to~     Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced~     Migraine-like Attacks in Migraine Patients.~   "
39320|NCT02542592|"~     The study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the~     effect on immune signaling and recovery after surgery.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will experience a~     positive modulation of the immune response and an enhanced recovery.~   "
39321|NCT02542579|"~     Diagnostic tests for Helicobacter pylori infection consist of noninvasive tests (i.e., urea~     breath test, serum antibody, stool antigen, urine antibody) and invasive tests (i.e.,~     histology, Giemsa stain, Warthin-Starry stain, Gram stain, culture, rapid urease test).~      Discrepancies between the tests may occur, and further induce problems for the diagnosis and~     treatment for H. pylori infection.~      Various types of microbiota can live together in a human stomach, and can be diagnosed using~     16S ribosomal ribonucleic acid (rRNA) pyrosequencing analysis based on multiplex polymerase~     chain reaction (PCR) method.~      With the progress of gastric atrophy, the numbers of gastric microbiota may increase due to~     the low acidity of the intragastric condition.~      As a consequence, H. pylori are derived out the stomach, and may show a negative findings on~     the H. pylori assays.~      The aim of this study is to evaluate how the composition of gastric microbiota differ~     according to the H. pylori test findings.~   "
39322|NCT02542566|"~     To test using a randomised control trial, whether conservative rehabilitation and protected~     weight bearing versus early weight bearing and accelerated rehabilitation affects patient~     outcomes post microfracture surgery of the knee.~   "
39323|NCT02542553|"~     The purpose of this study is to assess microbiologic concordance rates between right- and~     left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated~     pneumonia, identify predictors of concordance, and evaluate the impact of discordant~     microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the~     investigators conducted a prospective observational study in the general intensive care unit~     of a large university hospital.~   "
39324|NCT02542540|"~     Children with osteogenesis imperfecta are described as extremely sedentary and therefore~     fatigable, which strongly impacts their daily activities. The physical rehabilitation of~     these children is a fundamental aspect of treatment.~      It has been shown that playing Wii console causes the same increase in energy expenditure~     than practicing moderate exercise, while ensuring user safety. This type of physical~     exercise with this type of fun game console might have a role in the treatment of OI~     children on the physical side but also on the psychological side.~   "
39325|NCT02542527|"~     This study is an early (during the product development process) feasibility study. It shall~     evaluate the device design concept with respect to device functionality of a new fluid~     filled breast pump in a small number of subjects.~   "
39326|NCT02542514|"~     The study is an open label, prospective, multicenter, phase II study which aims to define~     ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma~     (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete~     response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease~     (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG)~     criteria.~   "
39327|NCT02542501|"~     The intention of this study is to investigate how many patients with prostate cancer,~     planned to be treated with LHRH analogues without history of surgery or radiotherapy, are~     suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses~     primary LUTS symptoms over time will be investigated.~   "
39328|NCT02542267|"~     The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of~     GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial~     Femoral Artery.~   "
39329|NCT02542254|"~     This study evaluates the addition of RPL554 to standard reliever medications for chronic~     obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in~     a randomised sequence:~        1. salbutamol,~        2. ipratropium,~        3. salbutamol + RPL554,~        4. ipratropium + RPL554,~        5. RPL554~        6. Placebo~   "
39330|NCT02542241|"~     The purpose of this study is to determine whether hypertonic saline solution is effective in~     the resuscitation of traumatized patients undergone abdominal damage control surgery~     regarding early closure of the abdominal wall.~   "
39331|NCT02542228|"~     This research is being done to construct a survey questionnaire, a quality of life tool, to~     determine the health, well-being, ability to perform daily activities, and physical, social~     and emotional functioning in participants with primary immunodeficiency disorders (PIDD).~     This quality of life (QOL) tool will help physicians understand the effects of PIDD on a~     person's health. These quality of life surveys are important tools for physicians to measure~     outcomes for satisfaction and effects of treatment.~   "
39332|NCT02542215|"~     To evaluate the efficacy, safety, and pharmacokinetics (PK) of liquid cobiprostone in~     preventing oral mucositis, when administered topically to the oral mucosa via spray for the~     duration of radiation and chemotherapy (RT/CT).~   "
39333|NCT02542202|"~     This pilot clinical trial studies the side effects and best dose of stereotactic body~     radiation therapy in treating patients with kidney cancer that has spread to other places in~     the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as~     stereotactic body radiation therapy, is a specialized radiation therapy that delivers a~     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause~     less damage to normal tissue.~   "
39334|NCT02542189|"~     The purpose of this study was to collect data on the prevalence and clinical significance of~     elevated cardiac troponin in a large registry of unselected patients with atrial~     fibrillation presenting to an emergency department.~   "
39335|NCT02542176|"~     The purpose of this study is to evaluate the effects of both chronic and acute grape~     ingestion in a population of men and women at higher risk for both type 2 diabetes and~     cardiovascular disease (metabolic syndrome).~   "
39336|NCT02542163|"~     Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless~     telemetry vest in cardiac rehabilitation.~      Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating~     the NimbleHeart chest harness system.~   "
39338|NCT02542137|"~     Patients with small cell lung cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung~          cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung~          cancer patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic small cell lung cancer.~   "
39339|NCT02542124|"~     In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor~     efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose~     TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned~     in this study, rather, a pre-defined starting dose will be explored; this dose is based on~     two safety and tolerability studies of NM-IL-12 in healthy volunteers.~   "
39340|NCT02542111|"~     This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of~     non-GCB DLBCL patients.~   "
39341|NCT02542098|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and~     effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe~     pain requiring around-the-clock opioid analgesics.~   "
39342|NCT02542085|"~     Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional~     hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair~     (laparoscopic mesh and fascial suturation).~      Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää,~     Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).~      Patients are randomized to operative groups (lap. vs hybrid).~      Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for~     their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score~     (VAS) are reported.~      The primary end-points:~        -  clinically and/or radiologically detected seroma in 1 month control~        -  clinically and/or radiologically detected recurrent hernia in 1 year control~      The secondary end-points:~        -  peri-and postoperative outcomes/ complications, morbidity, mortality~        -  duration of hospital stay~        -  pain scale (VAS)~        -  Quality of Life (SF/Rand36)~   "
39343|NCT02542072|"~     The purpose of this study is to compare the subjective performance of comfilcon A lens~     against samfilcon A lens after 4 weeks of reusable lens wear.~   "
39344|NCT02542059|"~     In order to evaluate the difference in beta cell mass in patients with and without complete~     resolution of type 2 diabetes mellitus (T2DM) after Roux en Y gastric bypass (RYGB)~     investigators aim to compare quantitative PET imaging of the pancreas between these patient~     groups.~      These highly relevant data will provide investigators with more information on the possible~     role of beta cell mass in the mechanisms behind resolution of T2DM after bariatric surgery.~     This would be of great interest for the assessment of RYGB as an alternative therapy in~     patients with T2DM with a BMI <35, who currently do not meet the international guidelines~     for bariatric surgery.~   "
39345|NCT02542046|"~     Although positive oral contrast agents are used for the majority of abdominopelvic CT scans~     in the United States, the quality of bowel opacification has not been compared between the~     three major classes of positive oral contrast material (barium sulfate, ionic iodinated~     contrast material, and non-ionic iodinate contrast material). This is a retrospective single~     institution study of clinical records to show whether the uniformity of bowel opacification~     is different between the three main types of positive CT oral contrast material used in the~     United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will~     retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate,~     and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the~     quality of bowel lumen opacification by the positive oral contrast agents.~   "
39346|NCT02542033|"~     Primary objective of this study is to investigate the effect of sugar reduction (starting~     from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by~     comparing the reference food item apple juice (control) with the test product (apple juice~     with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l~     resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of~     this study is to investigate the effect of sugar reduction on postprandial insulinemic~     response.~      Exploratory objectives are to investigate further characteristics of postprandial glucose~     and insulin response and insulin sensitivity, gastrointestinal side effects and safety~     aspects.~   "
39347|NCT02542020|"~     Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40~     million people infected worldwide. Due to highly active antiretroviral therapy, mortality~     related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades.~     However, liver disease remains as an important cause of severe complications and death.~      Hepatic fibrosis progression is the main responsible for liver-related outcomes in~     HIV-positive patients. Co-infection by hepatitis B (HBV) or hepatitis C virus (HCV) is~     highly prevalence in HIV patients. Chronic viral co-infection induces faster liver fibrosis~     progression compared to mono-infected HIV. However, published data have been reporting~     presence of significant liver fibrosis in HIV without HBV or HCV infection. This might be~     related to direct action of HIV in hepatocytes or association with others factors, such as~     non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with metabolic factors, such~     as obesity and type-2 diabetes mellitus. However, antiretroviral drugs may induce abnormal~     body fat distribution (lipodistrophy) and insulin resistance playing an important role on~     this process. Liver biopsy has been historically considered as the gold standard to evaluate~     liver injury. However, this painful method presents several limitations. Therefore, several~     non-invasive methods for estimation of liver fibrosis, such as biomarkers (APRI, FIB-4,~     FibroTest and FibroMeter) and transient elastography by Fibroscan, have been developed as an~     alternative to liver biopsy. The diagnostic performance and prognostic value of biomarkers~     and transient elastography have been validated in patients with chronic liver diseases.~     However, few data are available in HIV patients, especially in those without chronic viral~     co-infection.~      Therefore, patients, medical doctors and scientific community will be beneficiated by the~     future application of non-invasive methods for estimation of liver injury in clinical~     practice in HIV patients.~   "
39348|NCT02542007|"~     To evaluate the safety, efficacy and deliverability of the Combo bio-engineered~     sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the~     treatment of patients with de novo stenotic lesions of native coronary artery.~   "
39385|NCT02541526|"~     The purpose of this study is to evaluate tolerability, acceptability and potential efficacy~     of 4 months of maintenance treatment with Mirtazapine as compared to placebo for patients~     with co-occurring amphetamine-type stimulant and opioid dependence (COATS) receiving~     buprenorphine maintenance treatment (BMT) in Kota Bharu.~   "
39349|NCT02541994|"~     Patients in for treatment of benign intracranial hypertension will undergo two tests that~     are not routinely performed for these patients: central corneal thickness and axial length~     of the eye. The data obtained from these measurements will be assessed to see if the~     correlate with aspects of vision loss including visual acuity, visual field status, optical~     coherence tomography (OCT) results, and fundus photographs.~   "
39350|NCT02541981|"~     The outcome of heart transplantation has improved by years. The renal dysfunction is a major~     complication after heart transplantation.The natural course of renal function following~     orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on~     patients who received a heart transplant at National Taiwan University Hospital between 1987~     and 2015.~   "
39351|NCT02541968|"~     Randomized controlled non-inferiority trial comparing therapist-guided Internet-based~     Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT~     for Obsessive-Compulsive Disorder (OCD) in adults.~      The primary objective is to evaluate whether ICBT is a non-inferior treatment option~     compared to the best possible available treatment for OCD, individual face to face (f2f)~     CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT.~     As this question has cost implications for the health system, a third objective is to carry~     out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f~     CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred~     cases compared to self-referred patients. Finally, a fifth objective is to investigate~     whether genetic markers, in combination with clinical variables, can be employed to predict~     treatment outcomes with CBT in general.~      Research Questions:~      Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f)~     CBT with regard to OCD symptoms, function and quality of life?~      Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms,~     function and quality of life?~      Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?~      Q4: Is there a difference in treatment outcome between self-referred and clinical referred~     patients?~      Q5: Can clinical variables and genetic markers be useful to predict which patients will~     benefit from CBT?~   "
39352|NCT02541955|"~     This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to~     determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or~     disease activity scores improve with Acthar treatment.~   "
39353|NCT02541942|"~     This study is conducted globally. This study describes pharmacogenetic testing of saliva~     samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The~     objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the~     FVII gene in patients previously exposed to rFVIIa analogue.~   "
39354|NCT02541929|"~     Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the~     structure and function of brain cells.~      DHA fish oil has been shown to be beneficial in cognition in several animal studies;~     however, this effect in human studies is not clear. It is not known how much dietary fish~     oil can get into the human brain. Thus, exploring fish oil delivery in human brains is~     critical for designing appropriate interventions.~   "
39355|NCT02541916|"~     The purpose of this study is to validate and test a tolerance gene expression profile for~     the identification of operationally tolerant liver transplant recipients, allowing for the~     successful withdrawal of immunosuppression without rejection in these patients.~   "
39356|NCT02541903|"~     Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.~     Supportive evidence for the value of systemic therapy does not exist for this disease and~     there are no agents currently approved by regulatory agencies. This study will evaluate the~     drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif~     has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins~     that are also found in PSCC. The drug has the potential for some patients to exhibit a~     response contributing to a greater quality of life.~   "
39357|NCT02541890|"~     Aim is to study the effect of a work place intervention during a multicomponent~     return-to-work rehabilitation program on return-to-work. The intervention is compared with~     inpatient rehabilitation only, and participants will be recruited from the diagnostic groups~     dominating the sick-leave statistics, namely musculoskeletal disorders, common mental~     disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic~     fatigue.~   "
39358|NCT02541877|"~     To observe the clinical outcomes of the different valve sizing strategies treating type-0~     Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation~     (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic~     Stenosis(TAS).~   "
39359|NCT02541864|"~     According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing~     quadruple therapy was suggested to be the first choice for eradication therapy of~     Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy~     or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the~     recommended first-line treatment is unknown. The investigators compared the efficacy of~     14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line~     treatment.~   "
39360|NCT02541851|"~     The acute pain remains unfortunately a major health problem in intensive care patients.~     Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or~     therapeutic procedure, could contribute to an increase in the incidence or in the intensity~     of acute pain. The acute pain could impact on the prognosis of intensive care patients and~     on the patients perception of the quality of care.~      Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain~     after intensive care admission could threaten the physical and psychological recovery after~     the stay in the intensive care unit (ICU).~      If many studies have been conducted to improve the management of the acute pain in the ICU,~     only few data exist on the incidence and the risk factors of the chronic pain after a stay~     in a surgical intensive care.~      The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month~     chronic pain after a stay in our surgical ICU.~   "
39405|NCT02541266|"~     This research is aimed at finding out what may influence the decision of patients to~     participate in trials involving imaging so that the investigators may improve our future~     studies so they are more patient focused and acceptable in regards to scan schedules.~   "
39361|NCT02541838|"~     Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system~     impairments that accelerate age-associated limitations in functional independence and the~     risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in~     balance and mobility because of limitations metabolic abnormalities. The constellation of~     impairments accompanying type 2 diabetes diminishes muscle function and performance~     including strength and power. Loss of strength at higher speeds of movement (deficit in~     power) occurs in neural activation of muscles, changes in muscle properties, and through in~     older individuals with DPN compared to older controls. Consequently, this deficit in speed~     dependent muscle power production leads to limitations in rapidly responding to sudden loss~     of balance stability to prevent falling. The goal of this pilot research program is to~     determine the feasibility and effectiveness of a mechanism-based therapeutic intervention~     fro improving balance and mobility functions and preventing falls in older adults with DPN.~     The investigators pan to use the results from this pilot study to design and implement a~     larger randomized control trial.~   "
39362|NCT02541825|"~     This study evaluates the incidence of hepatic encephalopathy between covered stent of~     diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half~     of the participants will receive stent of diameter of 7mm ,while the other half will receive~     stent of diameter of 8mm.~   "
39363|NCT02541812|"~     The purpose of this study is two-fold: first, to observe the effect of one session of~     repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of~     patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and~     second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.~   "
39364|NCT02541799|"~     The investigators hypothesis is that patient comprehension of telemedicine-enabled research~     informed consent is not inferior to standard face-to-face research informed consent.~      The procotol will involve a prospective, randomized control trial to test the effectiveness~     of a telemedicine medium in obtaining research informed consent. Within a single emergency~     department, the investigators will conduct a simple, low risk randomized trial (single does~     of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with~     expected hospital admission). Prior to being approached for informed consent, potential~     participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent~     vs. consent provided by audio-visual telemedicine. After standard clinical care, potential~     participants will be approached according to their allocation. Comprehension of research~     informed consent will be the primary outcome, and will be measured using the modified~     Quality of Informed Consent (QuIC) instrument.~   "
39365|NCT02541786|"~     Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed~     release formulation. It is effective for symptom control of patients with gastroesophageal~     reflux disease. However, its efficacy in the treatment of H.pylori infection remains~     unclear. This study was conducted to investigate whether the efficacy of single-dose~     dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based~     triple therapy in the treatment of H.pylori infection.~   "
39366|NCT02541773|"~     The purpose of this study is to understand the behaviour of certain blood markers in~     patients with heart failure who undergo a cardiac device implantation procedure called~     cardiac resynchronization therapy (CRT). CRT is an effective treatment for heart failure,~     but up to 30% of people do not respond and have poor outcomes (1,2). Despite extensive~     investigation, identifying these patients continues to be a challenge. The study intends to~     describe the changes in these blood markers before and after CRT and to examine any~     potential clinical value.~      The idea behind the study is that these blood markers alter in heart failure and change with~     CRT implantation. Furthermore the pattern of marker expression before implant and after may~     predict response and outcome.~   "
39367|NCT02541760|"~     Otitis media is one of the most common infections among children and is a complication in~     about 30% of common colds. The most common complication of acute otitis media is otitis~     media with effusion. Some studies have reported the effects of montelukast and mometasone~     nasal spray in treatment of otitis media with effusion. However, current information is~     inadequate in this issue. The aim of this study was to compare the effectiveness of~     montelukast and mometasone nasal spray in treatment of otitis media with effusion in~     children attending Koodakan hospital in Bandar Abbas, Iran.~   "
39368|NCT02541747|"~     This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and~     staff during night shift.~   "
39369|NCT02541734|"~     The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been~     applied to determine beta cell mass in healthy volunteers and patients with type 1 diabetes.~     However, the high retention of the tracer in the kidneys was leading to a kidney/pancreas~     uptake ratio of 41±23. This high renal uptake is complicating absolute BCM quantification by~     SPECT imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a~     co-infusion with the plasma expander Gelofusine since it has been shown in several~     pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several~     other, closely related tracers. When investigators are able to reduce the kidney/pancreas~     uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT,~     having important implications for therapeutic decision making for patients with diabetes,~     insulinomas or congenital hyperinsulinism, and may also have a major impact on our~     understanding of the pathophysiology of these diseases.~   "
39370|NCT02541721|"~     The current study aims to investigate the effectiveness in clinical symptomatic control and~     tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar~     dermatoses.~   "
39371|NCT02541708|"~     Intravenous iron preparations have been shown to be superior to oral iron and have largely~     replaced the treatment of anaemia in Northern countries. However, the socio-economic and~     medical conditions in low resource countries greatly differ from those in northern~     countries. Patients' different access to medication supply, perception of medication need~     and compliance as well as the burden of concomitant disease like malaria, soil-transmitted~     helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence~     effectiveness and safety of iron substitution modality. The aim of the present study is to~     compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron~     substitution in a low resource country~   "
39372|NCT02541695|"~     Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already~     suitable for dietary interventions in its current form, further characterization of the~     working-mechanism of the attenuated strain and further optimization of the study design will~     enable the investigators to better select those ingredients that affect the key~     pathophysiological processes. The aim of the CORAL study is to further characterize and~     increase the discriminative power of the diarrhoeagenic E. coli challenge model.~   "
39373|NCT02541682|"~     In this study, the investigators aimed to research the relationship between affective~     temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The~     investigators aimed to assess temperament differences between healthy pregnant women and~     pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.~   "
39374|NCT02541669|"~     The purpose of this study is to assess the pharmacokinetics and safety of single- and~     multiple-dose of TAK-491 in healthy Chinese participants.~   "
39375|NCT02541656|"~     A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid~     administration can be directed by cardiac output monitoring which evaluate the response to~     repeated fluid challenge or by preload dependence indices. These indices are not well~     validated in laparoscopic surgery while pneumoperitoneum can alter venous return or~     pulmonary compliance.~      The aim of the study is to study the validity of pulse pressure variation to predict fluid~     response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on~     the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic~     waveform of pulse oximetry variation and the stroke volume variation.~   "
39376|NCT02541643|"~     To provide elotuzumab treatment for single-patient use.~   "
39377|NCT02541630|"~     A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and~     Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals~     experiencing mood and anxiety symptoms. The aim of this pilot study is to test the~     feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and~     other psychological symptoms.~      Big Mind is a method of self-exploration that utilizes a voice dialog technique to help~     individuals see the world and themselves from a variety of perspectives. The investigators~     hypothesize that this process will increase mindfulness and decrease self-referential~     thinking, which is associated with negative affect.~      To test the feasibility of using this method, veterans with PTSD will complete a four-week~     group Big Mind class with a total of four sessions. The investigators will use a single~     group design with pre and post-intervention measures to assess tolerability and acceptance~     of the intervention. Secondary outcome measures will evaluate symptom improvement and~     increased mindfulness.~      If this project demonstrates that using this intervention for veterans with PTSD is~     feasible, then more rigorous clinical trials will be warranted.~   "
39378|NCT02541617|"~     Outcomes study to test the hypothesis that patients first identified by community-based~     neurologists, implanted by a networked movement disorders center, and then managed by the~     same community-based neurologist will have clinical outcomes comparable to movement~     disorders centers.~   "
39379|NCT02541604|"~     This early phase, multicenter, open-label, single-arm study will evaluate the safety,~     tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of MPDL3280A in~     pediatric and young adult patients with solid tumors for which prior treatment was proven to~     be ineffective.~   "
39380|NCT02541591|"~     The primary objective of the Neuroprotect trial is to assess whether or not a new goal~     directed hemodynamic optimization strategy can reduce cerebral ischemia in post-cardiac~     arrest (CA) patients.~   "
39381|NCT02541578|"~     Physiological complexity of gait, a measure of the interaction of multiple control~     mechanisms for walking within a biological system, is decreased in persons with chronic~     stroke compared to those without disability. Thus, it is assumed that the quantification of~     gait complexity represents the adaptability and health of the individual. However, it is~     unknown if the level of gait-related complexity improves over time with recovery from~     stroke. Therefore, the primary purpose of this study is to determine if the physiological~     complexity of gait changes over the first six months post stroke within the contemporary~     healthcare environment. Secondary aims include 1) determining if there is a difference~     between the amount of physiological complexity of gait and lateralization of hemispheric~     damage after stroke and 2) exploring the relationship of complexity to lower extremity motor~     impairment, walking speed and balance. Sixty individuals within one month post stroke from~     the greater Indianapolis area will be recruited for this prospective, longitudinal outcomes~     study. Testing sessions will occur at intervals across the first six months post stroke:~     within 1 month, at 3 months, and at 6 months post stroke. During each testing session,~     participants will complete a 2-minute walking task during which accelerometer signals from~     wireless inertial measurement units will be collected and converted to sample entropy to~     quantify the physiological complexity of gait. Additionally, measures to quantify lower~     extremity motor impairment, walking speed and balance will be collected and analyzed.~     Changes in complexity of gait from early to later stages of stroke recovery may serve as a~     foundation for prognosticating outcomes, such as predicting capacity for community mobility~     and/or risk of fall. The proposed study will meet a critical need to develop methods that~     differentiate among capacities for adapting movement patterns in individuals with~     neurological dysfunction. This work will ultimately build upon evidence that will assist~     therapists in tailoring interventions in such a way to optimize function.~   "
39382|NCT02541565|"~     This pilot clinical trial studies the side effects of pembrolizumab and combination~     chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or~     grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab,~     may interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     pembrolizumab together with combination chemotherapy may be with a better treatment for~     diffuse large B-cell lymphoma or follicular lymphoma.~   "
39383|NCT02541552|"~     Adductor canal block is commonly offered to provide pain relief following knee surgery with~     the hope that they cause less leg weakness than traditionally performed femoral nerve block.~     Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting~     the advantages of the technique. Investigators want to find out the effective dose for a 30%~     response (volume of local anesthetic which would result in clinically significant weakness~     of the leg)~   "
39384|NCT02541539|"~     This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ)~     in prevention of upper respiratory and gastrointestinal illnesses, which are found common~     among adults in Malaysia aged from 18 to 81 years.~   "
43409|NCT02488798|"~     100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D~     power Doppler ultrasound using the international endometrial tumor analysis group and office~     hysteroscopy with taking samples for histopathological analysis.~   "
39386|NCT02541513|"~     The proposed study will evaluate the tolerability, acceptability and potential efficacy of~     paliparidone for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)~     dependence. In the proposed clinical trial, all patients will first discontinue illicit~     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the~     inpatient ward at the department of psychiatry before beginning to receive paliparidone.~     Tolerability and acceptability will be evaluated by assessing the rates of patient retention~     during treatment, patient satisfaction with treatment and adverse effects during treatment.~     The potential efficacy of paliparidone will be evaluated with regard to the primary outcome~     measure: reductions in illicit ATS use, based on urine toxicology testing and self-report.~     Secondary outcome measures include treatment retention, reduction in HIV risk behaviors and~     improvements in functional status.~   "
39387|NCT02541500|"~     The proposed study will evaluate the tolerability, acceptability and potential efficacy of~     minocycline for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)~     dependence. In the proposed clinical trial, all patients will first discontinue illicit~     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the~     inpatient ward at the department of psychiatry before beginning to receive minocycline.~     Tolerability and acceptability will be evaluated by assessing the rates of patient retention~     during treatment, patient satisfaction with treatment and adverse effects during treatment.~     The potential efficacy of minocycline will be evaluated with regard to the primary outcome~     measure: reductions in ATS use , based on urine toxicology testing and self-report.~     Secondary outcome measures include retention, reduction in HIV risk behaviors and~     improvements in functional status.~   "
39388|NCT02541487|"~     This is a cross-sectional comparison study of three maternal and fetal groups. Patients~     studied are women (and their fetus if they conceive) participating in the Reproductive~     Medicine Network's (RMN) FIT-PLESE investigation (funded, the NuPA and PAo arms) compared to~     control mothers who decline the intervention protocols and their fetuses if they conceive.~   "
39389|NCT02541474|"~     There is an urgent need to develop new care models for patients with long-term and complex~     needs. Our goal is services that are seamless, pro-active and person-oriented.~      Intervention:~      The Patient-centered health care team (PACT) is a service model for frail elderly patients~     with multiple long term conditions. PACT is a seamless and proactive health service model~     that aims to ensure safe early discharge and prevent hospital admissions for elderly frail~     patients. The four pivotal elements are are supported by theoretical and empirical~     underpinnings: 1) Inter-disciplinary comprehensive geriatric team: 2) Involving patients in~     care and self-management 3) Pro-active care plan: 4) One point of contact.~      Study Objective:~      1) To investigate whether the PACT model improves health-related quality of life and patient~     generated goals 2) carry out a health economic evaluation of PACT.~      Design:~      The evaluation model for complex interventions is our guiding evaluation framework. This is~     a non-randomized, matched control, before after study. The intervention unit, is the care~     organization, including four hospitals - municipality dyads. Two intervention dyads and two~     control dyads. Index patients from intervention hospitals will be matched age, sex and~     number of chronic conditions.~      Intervention group: Patients with emergency admission to the UNN internal medicine~     department in Tromsø and Harstad who are age > 65, have three or more long-term conditions,~     an emergency admission within the last year, and an informed consent is given by patient or~     next of kin. (Approved by ethics board 07.05.2015). The exclusion criteria are: Language~     barriers, and less than 3 months life expectancy.~      Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine~     departments, matched to the index patient's sex, age, number of long-term conditions.~     Control patients will be subject to the same data-collection as intervention patients.~      Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes:~     The primary outcome is the adjusted differences in the change of Quality of Life, measured~     by Short Form-36 (SF-36), physical health dimension between intervention and control groups~     at 6 months after inclusion in study.~   "
39390|NCT02541461|"~     Nutritional status including changes of body composition is one of the most important~     clinical determinants of outcome after gastrectomy for gastric cancer. The laparoscopic~     gastrectomy is considered to be minimally invasive and to have favorable outcome that is~     widely used in South Korea. It was reported that several advantages of laparoscopic~     gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at~     6 months after surgery. But there have been no longitudinal studies evaluating changes in~     the body composition according to the different type of anastomosis of laparoscopic~     gastrectomy.~      This study will therefore evaluate which of these two surgical procedures is most effective~     for postoperative body composition in laparoscopic gastrectomy patients, by comparing~     whether there are any differences in the amount of weight lost, lean body mass, fat mass,~     and lipid profile. It will help to better define the influence of anastomosis on changes of~     body composition after laparoscopic gastrectomy. This information can then be used by~     physicians to better make a plan to the patient's body make up and medical comorbidities.~   "
39391|NCT02541448|"~     This study is designed to evaluate physician preference related to the use of the SURGIQUEST~     AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of~     pneumoperitoneum.~   "
39392|NCT02541435|"~     In Europe, breast cancer is by far the most common form of cancer diagnosed in women today,~     accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is~     usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or~     trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast~     cancer patients.~      Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which~     includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke,~     and is the most common non-malignancy cause of death. During the last two decades, RT~     regimens for breast cancer have changed and the doses of radiation to which the heart is~     exposed are now potentially lower due to new and improved RT techniques. However, there are~     no data on whether these new regimes decrease the risk of cardiovascular disease.~      In this study the incidence and prevalence of cardiovascular diseases will be estimated 8~     and 15 years after both conventional and laser assisted breath controlled RT, and compared~     with cardiovascular diseases in the general female population. A further aim is to evaluate~     signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic~     resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac~     biomarkers and to investigate whether these signs can predict later cardiovascular disease.~     The importance of traditional cardiovascular risk factors (age, hypertension,~     hypercholesterolemia, smoking habits and physical activity, as registered before RT) will~     also be evaluated.~   "
39424|NCT02539303|"~     This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5~     (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower~     extremities in patients with severe peripheral arterial disease (PAD) who were deemed to~     have unreconstructable arterial disease and who have already been scheduled to undergo limb~     amputation (below knee or above knee amputation).~   "
39393|NCT02541422|"~     This will be a double-blinded study involving healthy non-alcoholic (self-reported)~     volunteers over the age of 21 to consume beer on hospital property in a safe environment to~     ensure immediate availability to medical attention and to security if needed. Volunteers~     will be recruited from residency programs, hospital employees, emergency medical personnel,~     and friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked~     with a breathalyzer. They will wear a tag around their neck with their study number, which~     will be hole-punched with every beer consumed, which will be collected at the end of the~     night for an accurate count of beers consumed per person. They however will not be forced to~     drink anymore if they are uncomfortable with the amount of alcohol they are consuming and~     can withdraw from the study at any time. All participants will be required to be driven home~     by a sober driver once the participant's BAT is 0.02 or less. At the end of the night, the~     volunteer will be breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed~     of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participate~     will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a~     0 - 4 point Hangover Symptom Severity scale. A random number generator will be used to~     determine Placebo or NAC first, then the participant will be given the other treatment at~     their subsequent encounter. The study will be conducted over the series of many months, and~     data can be analyzed by self-control comparing the participant's hangover symptom severity~     as determined by the hangover symptom scale data when using NAC compared to placebo. The~     data will be analyzed using the numerical values of each category for hangover~     classification and compare the placebo data to the control data.~   "
39394|NCT02541409|"~     The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24~     weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited~     setting. The investigators will compare treatment completion rates among 50 persons~     chronically infected with HCV who will be randomized to receive either 1) 12 weeks of~     sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of~     SOF + RBV. Treatment will be delivered daily by field workers at a location of a~     participants choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with~     or without PEG as measured by the proportion of subjects with sustained viral response at 12~     weeks after discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability~     of SOF+RBV with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.~   "
39395|NCT02541396|"~     To evaluate the safety and effectiveness of Wafermine administered with and without an~     opioid medication for acute pain following bunionectomy surgery.~   "
39396|NCT02541383|"~     The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib,~     Thalidomide and Dexamethasone will increase the stringent complete response rate after~     consolidation therapy and increase the progression free survival after daratumumab~     maintenance therapy in transplant eligible participants with previously untreated Multiple~     Myeloma.~   "
39397|NCT02541370|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.~   "
39398|NCT02541357|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing colorectal surgery.~   "
39399|NCT02541344|"~     In this trial, the investigational product , the active ingredients which has been proven to~     reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary~     aim of this clinical study is to evaluate the possibility of the investigational product to~     reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with~     normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in~     insulin levels.~   "
39400|NCT02541331|"~     This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve~     the asthma control level (ACT score) as add-on treatment to routine asthma treatment in~     children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150~     participants will receive Ismigen® and their current asthma therapy while the other half~     will receive Placebo and their current asthma treatment.~   "
39401|NCT02541318|"~     Among health problems of peri-menopausal women, sleep disturbances is very common complaint.~     The aim of this study is to realize the body constitution of the peri-menopausal women with~     sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see~     if this intervention can decrease the dosage of hormone replacement therapy.~      Quasi-experimental design and convenient sampling are both adopted. Participants will be~     recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of~     Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of~     participants who are willing to try Duo-in exercise to improve their sleep quality will be~     randomly assigned into experiment group and control group. The experiment group will~     practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention~     in the control group. Then, after 2 weeks, the participants of experiment and control group~     will crossover. The experiment group has no intervention, but the control group will~     practice Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index~     (CPSQI), Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and~     peri-menopausal fatigue scale will be used in the assessment at each time point. According~     to previous experience, a total of 70 participants will completed the whole observation~     course. Generalized estimating equations (GEE) is applied to analyzed the repeated~     measurement of different time and groups.~      This study will provide the evidence for Duo-in exercise as complementary treatment for~     hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in~     exercise into mainstream treatment for other patients with sleep disturbance.~   "
39402|NCT02541305|"~     Knowing the effects of proprioceptive exercise program in improving balance, gait and risk~     of falls in institutionalized elderly.~   "
39403|NCT02541292|"~     Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy~     with approximately 500 patients in Denmark. It is characterized by weakness and wasting of~     the facial muscles, the muscles in the shoulder region and of the legs.~      The primary aim of this study is to investigate possible links and order between~     inflammation and fat infiltration in the muscles in patients with FSHD.~      Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year~     where the inflammation and fat infiltration in the muscles can be quantified.~   "
39404|NCT02541279|"~     The investigators determined the effectiveness of a group intervention for the treatment of~     shoulder pathologies.~   "
39406|NCT02541253|"~     1. Part 1 If study subject and legal guardians who decide voluntarily to participate the~          clinical trial, and sign the Informed Consent Form (In the case of study subject less~          than 7 years of age, written informed consent by study subject's legal guardians),~          study subjects eligible for participating this trial protocol were assigned to test~          group and receiving the test drug 1 times or 2 times according to age.~        2. Part 2 If study subject and legal guardians who decide voluntarily to participate the~          clinical trial, and sign the Informed Consent Form(In the case of study subject less~          than 7 years of age, written informed consent by study subject's legal guardians), the~          study subjects eligible for participating this trial protocol were assigned to test~          group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2~          times according to age as below;~             -  6 m ~ 3 years~             -  3 years ~ 9 years~             -  9 years ~ 19 years~   "
39407|NCT02541240|"~     Health professional students experience high levels of psychological stress. Individuals~     with higher levels of resilience are better equipped to handle stress. The purpose of this~     study is to evaluate the effects of an 8-hour resilience curriculum on stress levels,~     resilience, coping, protective factors, and symptomatology on students enrolled in a doctor~     of physical therapy (DPT) program.~      Hypothesis: The curriculum will decrease stress levels, increase resilience, coping~     flexibility, protective factors (optimism, positive affect, and social support), and reduce~     symptomatology (negative affect, illness). Research on stress and its consequences~     experienced by physical therapy students in particular is limited. If the results of this~     study support this hypothesis, it may establish the benefit of adding a resilience component~     to the curriculum for students of physical therapy.~   "
39408|NCT02541227|"~     Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine~     treatment of patients with acute ischemic stroke.~   "
39409|NCT02539498|"~     Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by~     Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact~     of excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative~     Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well~     as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has~     shown that decreased microarchitectural parameters are associated with reduced bone strength~     independently of BMD. The purpose of this study is to characterize the impact of PHPT in~     cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed~     for one year, in comparison with control postmenopausal women.~   "
39410|NCT02539485|"~     The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on~     respiratory mechanics and sore throat was investigated.~   "
39411|NCT02539472|"~     Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the~     accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches~     and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and~     the differential diagnosis with inflammatory dermatoses is often very difficult. The~     histopathological diagnosis is also difficult and delayed. Therefore, it is important to~     develop biomarkers and/or a combination of biomarkers in order to improve the early~     diagnostic of MF.~      In a previous trial, investigators included 490 patients in a study aiming at identifying~     skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be~     interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later~     evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This~     French institutional study demonstrated that the identification by PCR of a combination of 4~     blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis~     of lymphoma in erythrodermic patients. This previously published study interestingly showed~     that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the~     blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic~     tool for MF.~      The aim of this study is to establishing an accurate blood diagnosis for early suspected MF~     by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR~     receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX,~     Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF~     and patients with inflammatory dermatoses closely resembling MF lesions.~      Statistical analysis will establish the best combination of blood biomarkers allowing the~     differentiation between the two groups of patients, combination that could represent a~     suitable diagnostic tool for early MF.~   "
39412|NCT02539459|"~     The purpose of this research study is to see if oral everolimus is tolerable and effective~     in the treatment of sporadic Angiomyolipomas (AMLs). AMLs are the most common non-cancerous~     tumor of the kidney. They are composed of blood vessels, muscle cells and fat~     cells.Everolimus is already an approved drug for several other diseases like kidney cancer,~     but is being studied now specifically to see if it is helpful for people with AML.~   "
39413|NCT02539446|"~     Inherent with intricate allocation of brain resource and attention shift,~     postural-suprapostural task is defined as postural control takes place while the other~     concurrent task is being performed. Recent studies have indicated that attentional focusing~     alters attention allocation in the brain as well as motor performance of a~     postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an~     external focus relative to internal focus for motor performance. However, postural~     difficulty might be a critical factor for choosing an appropriate focusing strategy, and the~     strategy used in a particular difficulty level do not always generalize to other difficulty~     levels. Besides, despite a lot of studies have been done, current findings are confined to~     behavioral observations in young healthy adults for lacking direct neural evidence. With the~     uses of H-reflex, event-related potential and behavioral measures, the purpose of the 3-year~     research project is to investigate the differences in performance quality and intrinsic~     neural mechanisms of a postural-suprapostural task for older adults and patients with~     Parkinson's disease, by adopting external and internal strategies for suprapostural task~     under different posture difficulties. In the first year, the investigators will characterize~     suprapostural focusing effect on reciprocity of a postural-suprapostural task, with a~     special focus on modulation of motoneuron excitability in sitting and standing posture for~     healthy young and older adults using H-reflex technique. In the second year, the adaptive~     selection of suprapostural focusing strategy will be investigated for patients with~     Parkinson's disease by varying the standing surface (stable/unstable surface). In the third~     year, the investigators will investigate suprapostural focusing effect on brain resource~     allocation for patients with Parkinson's disease, in light of event-related potential and~     movement-related potential. The present project is expected to have significant~     contributions not only to gain a better insight to neural correlates of concurrent postural~     and motor suprapostural tasks with internal/external focusing strategy under different~     posture difficulty, but to optimize treatment strategy for older adults and patients with~     Parkinson's disease with balance or multi-tasking disturbances.~   "
39414|NCT02539433|"~     Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is~     suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET~     and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a~     similar protocol as they had used for PET (Positron emission tomography) or FDG~     (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States~     Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation~     Safety Committee in 1989 and 1994 for the study of neurological diseases and used~     uneventfully.~   "
39425|NCT02541201|"~     This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical~     trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk.~     Half of the participants will consume of 1.5g of plant sterols daily as provided by two~     servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while~     the other half will consume placebo low-fat milk.~   "
39415|NCT02539420|"~     Though BiPAP is an increasingly common tool used by pediatric critical care physicians and~     there is promising data suggesting a role for BiPAP in the management of status asthmaticus,~     more information is needed to more definitively clarify the extent of its benefit, as well~     as when during an asthma exacerbation and in whom it is the most beneficial. In this study,~     which is among the first randomized studies of BiPAP use for status asthmaticus in the~     pediatric population, the investigators hope to better elucidate these issues to help guide~     clinicians' future management decisions.~   "
39416|NCT02539407|"~     Concentrations and effects of anti-infectives in critically ill children are unpredictable~     and the risk of under-exposure may be associated with poor clinical outcomes. In addition,~     between-subject variability (BSV) is known to be substantial in critically ill children.~     Rationalisation of anti-infectives in children is therefore desirable.~      The investigators aim to investigate, using a population approach, the pharmacokinetics (PK)~     and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) > minimal~     inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill~     children. Covariates The effects of covariates on anti-infectives PK and PK/PDs are~     investigated in order to better explain the BSV and to ultimately suggest individualized~     dosage regimens.~      It will be a prospective PK study including 11 anti-infectives antibiotics. Six blood~     samples were taken from each patient during dosing interval. The primary PK/ PD targets were~     anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and~     100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic~     regression to describe the effect of anti-infectives exposure on patient outcome.~   "
39417|NCT02539394|"~     The purpose of this study is to determine what effect intraoperative topical steroids have~     on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.~   "
39418|NCT02539381|"~     Visual impairment can affect up to 70% of stroke survivors, but many do not have their~     vision adequately assessed in hospital. An unidentified visual defect can cause significant~     problems for recovery and quality of life. The Stroke Vision app (an application currently~     scaled for a 10 Android tablet) has been developed to act as a screening tool for visual~     problems in stroke survivors; to help identify visual problems earlier and thereby improve~     rehabilitation outcomes. The app includes a suite of tests for assessing the patient's~     acuity, their visual fields and to aid in the identification of visual neglect /~     inattention. Furthermore, it includes educational information on visual stroke in order to~     better educate staff, patients and their carers. This study seeks to validate the novel~     digital assessments included in the Stroke Vision app against the current methods used for~     screening (clinical examination by confrontation field testing). Both screening measures~     will be compared with the gold standard methods for visual assessments, Octopus perimetry~     for fields and paper-based methods for visuospatial neglect~   "
39419|NCT02539368|"~     This is a post-marketing observational study of patients with Inflammatory Bowel Disease~     (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra~     (infliximab) or Remicade (infliximab) for treatment. Inflectra is a biosimilar medicine to~     Remicade, meaning it is a biologic medicine that contains the same active substance as~     Remicade (infliximab). The key study objectives are as follows:~        -  To characterize the population and drug utilization patterns of patients treated with~          Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of~          standard of care Remicade~        -  To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of~          patients with CD or UC in the context of standard of care Remicade~        -  To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in~          the context of standard of care Remicade~        -  To evaluate the immunogenicity profile of Inflectra in the treatment of patients with~          CD or UC~        -  To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work~          productivity and healthcare resource utilization (HRU) in patients treated with~          Inflectra for CD or UC~   "
39420|NCT02539355|"~     Obesity is a risk factor for several common cancers, including those of the breast, colon,~     liver, and pancreas. Proposed molecular links between obesity and these types of cancer~     include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of~     sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic~     inflammatory processes in expanded adipose tissue. The objective of this proposal is to test~     the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.~   "
39421|NCT02539342|"~     The purpose of this study is to determine if the administration of Caphosol rinse, at the~     start of chemotherapy, will prevent the development of mucositis (greater than or equal to~     grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.~   "
39422|NCT02539329|"~     Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are~     responsible for pain, balance disorder (ataxia) and the use of hands. They depend on~     multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3~     antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators~     believe that other antibodies can be discovered in patients who remain seronegative~     changing.~      However, the study is retrospective and only a small number of patients could be identified.~     Several points therefore need to be clarified or confirmed in a second prospective study.~   "
39423|NCT02539316|"~     Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the~     patient's nutritional status justifies it and enteral is impossible. In the literature,~     hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is~     described in the context of a long-term PN especially in premature infants. It results in an~     increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid),~     was studied in the adult population and in the preterm in the PN on short and long, with the~     finding of a hepatoprotection. Investigators do not find a single retrospective study about~     it in Pediatric Onco-Hematology. No prospective studies have been performed in the~     population of Onco-Hematology. The objective of this study is to evaluate the impact of the~     use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with~     Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric~     population.~   "
43641|NCT02485769|"~     A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group,~     Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And~     Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects~   "
39426|NCT02541188|"~     Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast~     cancer in young women (< 40years old) is more aggressive in the Maghreb countries~     comparatively to western countries. This aggressiveness could be associated with phenotypic~     and genotypic differences between this two populations.~   "
39427|NCT02541175|"~     This study is designed to prove new methods to enable the automated analysis of esophageal~     electrocardiography (eECG) signals in long-term measurements as well as the detection of~     atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable~     atrial and ventricular ECG signal distinction and the detection of atrial fibrillation.~     Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part~     in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG~     will be taken for about half an hour. Patient undergoing a cardiac catheter ablation during~     their current hospitalization will be further asked to allow access to the invasively~     obtained measurements (i.e. atrial potential map) to further improve the understanding of~     the eECG signals.~   "
39428|NCT02541162|"~     In a perspective of improvement of the global care of the patients, investigators wish to~     estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a~     clear, written and oral information, on the sexual satisfaction of the couples during~     treatments.~      Further to this study, the project will be to train and to sensitize the medical staff, or~     still to develop new activities to meet the needs better of patients and of partners.~   "
39429|NCT02541149|"~     This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel~     diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha~     fetoprotein the current marker ofhepatocellular carcinoma (HCC).~   "
39430|NCT02541136|"~     Stress-related disorders have a profound impact on public health. The World Health~     Organisation (WHO) found major depressive disorder (MDD) to be one of the most important~     human health problems with a prevalence of about 10%. In the current proposal the aim is to~     investigate mechanisms of resilience against stress-related disorders and to examine changes~     in quality of life, health, brain structure and brain function in individuals performing a~     resilience programme. Therefore, the investigators will recruit forty healthy subjects~     from the hospital staff exposed to normal day-to-day stress and not participating already~     in a fitness programme. Half of the subjects will be randomised to a cognitive behavioural~     self-experience and exercise programme for 20 weeks carried out by experienced supervisors,~     coaches and trainers. Clinical psychological and psychiatric examinations will be carried~     out weekly and a range of sophisticated neuroimaging techniques - high angular resolution~     diffusion imaging (HARDI) and functional MRI (fMRI) - will be conducted before and after the~     resilience program in order to investigate its effectiveness on brain structure and~     function. The stress system will also be tested by examining cortisol awaking response (CAR)~     and daily rhythms of cortisol secretion. These techniques are all well established in our~     laboratories. The proposed research will likely stimulate the development of new prevention~     strategies for this common and important disorder, and in the future could be applied to~     other illnesses. Moreover, when successful it could be patented and offered for~     implementation in the daily routine of median to large companies.~   "
39431|NCT02541123|"~     The primary objective of the clinical trial is to evaluate the effect of time on levels of~     Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP)~     biomarker levels in a population of head injured subjects over the age of 18 presenting~     acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control~     subjects.~   "
39432|NCT02541110|"~     Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be~     followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth~     retardation) & other obstetric complications.~   "
39433|NCT02541097|"~     This study will establish factors fundamental to the improvement in communication and~     quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is~     a type of dementia in which language declines but other cognitive skills (including memory)~     are preserved in the first several years after the onset. This makes those in the initial~     stages of PPA excellent candidates for treatment and creates a window of time (2-7 years)~     whereby they can lead independent lives with minimal support. However, currently, no~     communication therapy is available to people with PPA due to the progressive nature of the~     disorder and lack of awareness of available options for professionals willing to treat it.~      Participants with PPA in our study will receive two kinds of therapy for the words they~     cannot recall spontaneously, and will be trained to maintain them through social~     interaction. The type of training will be based on the most successful interventions the~     investigators provided to people with PPA in our previous work. The investigators expect~     that successful re-learning of forgotten words and practicing them in a group setting will~     facilitate retention of communication skills leading to greater personal independence and~     increased/maintained quality of life for people with PPA. Our study represents natural~     combination of two novel approaches for PPA that ultimately will lead to lower demands on~     the health care system.~   "
39434|NCT02541084|"~     This study aims at investigation of the caregiver burden of Wet Age-related Macular~     Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be~     reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural~     settings where public transportations are not readily available.~   "
39435|NCT02541071|"~     Intrusive memories of traumatic events are core features of posttraumatic stress disorder~     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of~     this study was to determine whether the activity of the noradrenergic system during an~     intrusion-inducing stressor influences subsequent intrusive memories.~   "
39436|NCT02541058|"~     This study is being conducted to develop and evaluate a cell-free fetal DNA test (Ariosa~     Test) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.~     Investigators will be evaluating subjects with abnormal U/S.~   "
39437|NCT02541045|"~     The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients~     with biopsy-proven non-alcoholic steatohepatitis.~   "
39756|NCT02536599|"~     The aim of the study is to identify clinical and laboratory parameters, present at the time~     of initial evaluation that could help predict which children with cancer, fever, and~     neutropenia will be at risk for developing clinically documented infections and/ or~     complications.~   "
39438|NCT02541032|"~     The PREMIERS study is a proposal for conducting an adequately powered two center phase III~     randomized controlled trial to test whether intensive periodontal treatment reduces the risk~     of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the~     resources in both states including established dental centers, Joint Commission Certified~     Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to~     Eliminate Health Disparities. The proposal addresses specific issues with regards to~     recruitment of African-American and rural stroke/TIA patients advocating the use of~     culturally appropriate strategies to educate the study subjects regarding stroke,~     periodontal disease and the periodontal stroke link.~      The study proposes to utilize economic evaluation of the periodontal intervention from the~     budgetary perspective. The focus will be on the financial sustainability of providing~     aggressive periodontal therapy (with certain, although relatively low expenditures) in~     exchange for a reduction of uncertain recurrent vascular events that may require high cost~     emergency department utilization and/or inpatient care. The sustainability of the proposed~     intervention after the completion of the project is integrally linked to the health economic~     assessment to show the health care cost savings. By integration with a rural primary care~     center, with an African American majority and households with average incomes below the~     state average, the study ensures that the proposed intervention to reduce stroke disparity~     is applicable to this target population.~   "
39439|NCT02541019|"~     Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still~     frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the~     main characterized prophylactic agents in patients at high risk, however there are few~     studies comparing the efficacy of these drugs and no study that addresses women aged over 60~     years.~      In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing~     laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic~     induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis~     of PONV.~   "
39440|NCT02541006|"~     The objective of this study is to compare the bronchodilator efficacy a of tiotropium~     inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in~     patients with moderate to severe chronic obstructive pulmonary disease (COPD).~   "
39441|NCT02540993|"~     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition~     to standard daily therapy, is effective and safe in treating patients with type 2 diabetes~     mellitus and diabetic kidney disease, when compared to a placebo.~   "
39442|NCT02540967|"~     The objectives of this study are to investigate the safety and effectiveness of Gadovist.~   "
39443|NCT02540954|"~     To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT)~     treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)~   "
39444|NCT02540941|"~     The investigators will extract single cells and analyze the molecular composition of single~     cells as well as bulks using the latest protocols for single cell and bulk genomics analyses~     including genetic, epigenetic, transcriptomic and proteomic analyses using the latest~     available protocols. A broad list of such example protocols are listed below.~      The samples and their molecular characterization (including sequencing & molecular levels)~     will serve as the basis for development of methods for single cells analysis. The developed~     methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single~     cells and share the same structure: the measured feature will be translated to a DNA library~     which will represent the feature by a dedicated assay.~      This library alongside with proper mathematical analysis of the sequencing results will be~     performed in order to conclude the desired feature. The general structure of such protocols~     is described in our review paper (Single-cell sequencing-based technologies will~     revolutionize whole-organism science, E. Shapiro, T. Biezuner & S.Linnarsson, Nature Reviews~     Genetics 14, 618-630, 2013) which is attached to our proposal.~      In addition, the researchers will use sequencing based methods (existing and future~     developed) in order to compare single cells and bulks from different tissues and/or~     different time points from the same donor in order to measure genetic, epigenetic,~     transcriptomic, and proteomic diversity.~   "
39445|NCT02540928|"~     The purpose of this study is to determine whether a drug called AMG 319 has an effect on a~     patient's own immune response to head and neck cancer squamous cell carcinoma (HNSCC). This~     study is specifically for patients who are having surgery to treat their HNSCC~   "
39446|NCT02540915|"~     The Chest Wall and Spine Deformity Registry is a tool designed to assist spine surgeons to~     efficiently identify and track patients with chest wall and spinal disorders.~   "
39447|NCT02540902|"~     This will be a prospective single cohort investigation of the Columbus all polyethylene~     tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The~     aim of the project is to determine post-operative outcome of the all polyethylene tibia up~     to two years.~   "
39448|NCT02540889|"~     The main aim is to develop and test the clinical efficacy of a novel, web based,~     rehabilitation application. Listen-In will provide an effective speech comprehension~     training tool that patients with aphasia can use to practice independently. This will free~     up therapists time to provide additional assessment, supervision and functional intervention~     in a highly cost effective manner.~   "
39449|NCT02540876|"~     This pilot phase I trial studies how well ilorasertib works in treating patients with~     cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to~     other places in the body and usually cannot be cured or controlled with treatment (advanced)~     or have spread to other places in the body (metastatic) and cannot be removed by surgery.~     Ilorasertib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
39450|NCT02540863|"~     Objectives: The aim of this research is to compare the effectiveness of myofascial release~     therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint~     sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction~     syndrome.~      Material and Methods: A single-blind randomized clinical trial will be conducted in a~     university research clinic. Sixty-four subjects with temporomandibular disorders and~     myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group~     (myofascial release protocol and Rocabado exercise therapy) and control group (exercise~     therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and~     joint sounds will be collected at baseline, and forty-eight hours after the intervention~     phase.~   "
39451|NCT02540850|"~     The purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay~     in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic~     screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by~     BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics~     AG, the producer for Epi proColon 2.0 CE.~   "
39452|NCT02540837|"~     A higher number than expected of patients with hip fracture have only insufficient analgesic~     effect of a femoral nerve block, which is the nerve block commonly used for this group of~     patients. One of the possible causes of this failure to provide analgesia from a single~     nerve block could be the that other nerves are involved in transmitting the pain signal. One~     of the nerves that is believed to give off branches to the hip is the obturator nerve.~      With ultrasound it is possible to make a selective proximal nerve block of the obturator~     nerve.~      The aim of this trial is to test the analgesic effect of a femoral nerve block i combination~     with an obturator nerve block compared to femoral nerve block alone in a randomized and~     placebo controlled design.~   "
39453|NCT02540824|"~     RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer~     (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase~     show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an~     oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the~     safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.~   "
39454|NCT02540811|"~     The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have~     been implanted with the investigational product following a ruptured anterior cruciate~     ligament (ACL) of the knee.~   "
39455|NCT02540798|"~     This study will look at how pre-test anxiety levels affect the reproducibility of symptoms~     during routine urodynamic testing in women. Urodynamics is a test that assesses the function~     of the lower urinary tract, including the bladder.~   "
39456|NCT02540785|"~     The aim is to evaluate the short-term changes in ocular surface measures and tear~     inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule~     extraction (SMILE) procedures.~   "
39457|NCT02540772|"~     Confabulators consistently generate false memories without intention to deceive and with~     great feeling of rightness. However, there is currently no known effective treatment for~     them. In order to fill this gap, the aim of this trial was to design a neuropsychological~     treatment based on the current theoretical models and test it experimentally in two groups~     of confabulators: experimental vs. control. The treatment consisted of some brief material~     that patients had to learn and recall at both immediate and delayed moments. After both~     recollections, patients were given feedback about their performance (errors and correct~     responses). Pre-treatment and post-treatment baselines were administered. Confabulators in~     the control group performed the baselines without treatment, and were then offered the~     treatment after the second baseline.~   "
39458|NCT02540759|"~     The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid~     (EPA) in blood and circulating cells will be investigated.~   "
39459|NCT02540746|"~     The aim of this pilot study is to examine a brief manualized treatment, Emotional Regulation~     Group Skills Training (ERG ST), which has shown promise with high-risk youth presenting with~     a range of mental health concerns. The investigators will examine the effectiveness of a ERG~     ST group, as well as two additional components to which clients will be randomized: a~     motivational enhancement (ME) pre-treatment, and family skills treatment (FAM). This project~     will be the first to combine and test these modules as a transdiagnostic early intervention~     for youth in the early stages on mental illness. This pilot trial will answer the following~     questions: 1) What is the response rate to ERG ST compared to ERG ST plus FAM, and who~     benefits? 2) What is the response rate to a ME pre-treatment, and who benefits? 3) What is~     the acceptability of this treatment?~      The ME pre-treatment will consist of four weekly one and a half hour sessions. The 12-week~     ERG ST will consist of 12 weekly two-hour sessions with 4-12 youths per group. The 12-week~     FAM will consist of 12 weekly two-hour sessions, with 16-20 caregivers per group. This study~     will use a two-stage randomization design to allow for balanced groups if there is~     differential attrition after pre-treatment. The following are the four treatment~     combinations: ERG ST; ERG ST+FAM; ME+ERG ST; ME+ERG ST+FAM. Four subjects will be enrolled~     in the study and randomized. The primary outcome is to improve emotion dysregulation in~     participants. Emotion dysregulation will be measured using the Difficulties in Emotion~     Regulation Scales (DERS).~   "
39460|NCT02540733|"~     Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction~     (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis~     compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown~     that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar~     with the findings in mice models. In this study, with multi-modal MRI technologies,~     investigators tend to observe structural and functional changes of the brain in both DM and~     non-DM CI patients and assess their neural rehabilitation using clinical scales in the~     following 6 months. Investigators also expect to find out dynamic changes of brain structure~     and function, to reveal the weights of factors including brain blood vessels, nerves and~     function remodeling related with stroke recovery, as well as the potential mechanism in CI~     patients with DM.~   "
39461|NCT02540720|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of severe HSP in children.~   "
39471|NCT02540590|"~     Our overall goal is to characterize the role of the microcirculation in healing oral mucosa~     after routinely applied surgery intervention in order to facilitate treatment. Using Laser~     Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators~     will have the possibility to detect functional alterations in gingival microcirculation in~     case of wound healing. After periodontal surgery, by means of the detection of~     microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the~     healing procedure and obtain data so as to design e.g. the incision line that takes~     microvascular anatomy into account, thus result in better wound healing later on.~   "
39472|NCT02539290|"~     The purpose of this study is to determine whether preovulatory uterine flushing with~     physiological saline is effective in the treatment of unexplained infertility.~   "
39462|NCT02540707|"~     Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female~     population. Antimuscarinics can affect autonomic system, arterial stiffness and~     psychosomatic distress. However, there is no such research for the new drug- mirabegron (a~     β3-agonist). Thus, the aim of our study is to analyze the between-group differences in heart~     rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic~     distress, personality trait, family support and clinical outcomes between the mirabegron and~     the solifenacin groups.~      Patients and Methods: The investigators will perform a prospective randomized controlled~     study to recruit 150 female OAB patients at the outpatient clinic of Department of~     Obstetrics and Gynecology of National Taiwan University Hospital. All OAB female patients~     will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores~     questionnaires, King's Health questionnaires, UDI-6 & IIQ-7, Patient Health Questionnaire,~     brief symptom rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability,~     partnership, growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit~     Questionnaire, standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring,~     cardio-ankle vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies~     and measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron~     versus solifenacin treatment. STATA software is used for statistical analyses.~      Possible Results: The investigators can answer that the between-group differences in heart~     rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic~     distress, personality trait, family support and clinical outcomes between the mirabegron and~     the solifenacin groups. The above conclusions should be important for pre-treatment~     consultation.~   "
39463|NCT02540694|"~     Rationale:~      Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose~     sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is~     indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal)~     for mediastinal nodal sampling is under discussion.~      Secondly, which needle size or type provides optimal tissue sample quality for granuloma~     detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue~     acquisition of small core biopsies in addition to cytological aspirates.~      Hypotheses:~        1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14%~          higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided~          nodal sampling in patients with suspected sarcoidosis stage I/II.~        2. 25G ProCore needles provide superior sample quality compared to conventional 22G~          needles in patients with suspected sarcoidosis stage I/II.~      Study design:~      Investigator initiated, randomized clinical trial. Setting: International, multicenter~     (university and general hospitals)~      Study population:~      Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II~     and an indication for tissue verification of non-caseating granulomas are eligible for~     inclusion.~      Intervention:~      EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.~      Main study endpoints:~        1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic~          lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in~          patients with suspected sarcoidosis stage I/II.~        2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected~          sarcoidosis stage I/II.~   "
39464|NCT02540681|"~     The aims of this study address an exploratory endpoint in the Major Extremity Trauma~     Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that~     is investigating prosthesis fit, alignment and condition of the residual limb. As there are~     no validated measures of fit and alignment (factors known to impact comfort, function and~     performance among amputees) the TAOS study includes a provision in the protocol for~     acquisition of photographs, video and radiographs in order to help develop uniform~     assessments of the residual limb. The goal of the ProFit study is to validate and refine the~     prosthetic assessment tool (ProFit) that was developed by an expert panel of certified~     orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a~     measurement scientist and a biomedical engineer from the BADER consortium.~   "
39465|NCT02540668|"~     The purpose of this study is to look at how much warfarin gets into the blood stream and how~     long it takes the body to get rid of it when given both with and without AZD3293. Another~     purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when~     given with AZD3293 by measuring international normalized ratio (INR). INR measures the time~     it takes for blood to clot and compares it to an average. Information about any side effects~     that may occur will also be collected. The study will last about 5 weeks from the first dose~     to follow-up for each participant.~   "
39466|NCT02540655|"~     The purpose of the clinical trial is to study the therapeutic efficacy and safety of~     Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized,~     double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal®~     through intravenous infusion.~   "
39467|NCT02540642|"~     Increased plasma homocysteine level is associated with macroangiopathy and nephropathy in~     type 2 diabetes. Also increased levels of serum homocysteine are associated with~     microalbuminuria which is associated with increased cardiovascular morbidity and mortality~     among the patients with type 2 diabetes. With B12 supplementation homocysteine level can be~     reduced .Type 2 diabetes as a metabolic syndrome may show improvement in glycaemic control~     with Vitamin B12 therapy as there is correction of hyperhomocysteinemia. In studies it is~     proved that combination of vit B12, folic acid and vit B6 are effective for~     hyperhomocysteinemia.There are no such separate trials on the use of vit B12 alone. This~     therapy may be used in large number of type 2 uncontrolled diabetic hyperhomocysteinemic~     patients.~      this study was planned with following objectives to study effect of Vitamin B12~     supplementation on glycaemic control in poorly controlled hyperhomocysteinemic type 2~     diabetic patients~        1. Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline~          and 4 weeks~        2. Fasting blood sugar level at baseline and 4 weeks~        3. Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks~        4. Serum lipid profile at baseline and 4 weeks~   "
39468|NCT02540629|"~     This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by~     2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2)~     multi-tiered response team CPR, and 3) feedback CPR.~   "
39469|NCT02540616|"~     The goal of this study is to determine whether external neuromodulation using transcranial~     electrical stimulation (TES) can reduce the perception of self-motion that is experienced by~     patients with MdDS. Mal de debarquement is translated as the sickness of disembarkment,~     and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive~     motion. A similar form of rocking dizziness can be experienced without a motion trigger in~     individuals with certain risk factors.~      Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine~     whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as~     an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic~     stimulation. The investigators will determine the optimal treatment duration and stimulation~     parameters.~   "
39470|NCT02540603|"~     This investigation is designed to evaluate the performance (leak and comfort) as well as~     participant's overall acceptance of the investigative full face mask amongst OSA~     participants.~   "
39484|NCT02539134|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     multiple rising doses of TAK-935 in healthy participants.~   "
39473|NCT02539277|"~     Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients~     with acute upper respiratory infection: A double blind, double dummy, randomized, controlled~     trial. It is a post-marketing clinical study to evaluate effectiveness, safety and~     cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection.~      Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness~     on Jinyebaidu granule in treating patients with acute upper respiratory infection.~      Study design：multi-center double-blind, double-dummy, randomized, controlled trial~   "
39474|NCT02539264|"~     In this study the investigators will analyze the influence of smoking, benzodizepine use,~     and obesity among patients with severe Obstructive Sleep Apnea (sOSA).~   "
39475|NCT02539251|"~     Early detection and intervention for developmental delays are crucial in promoting healthy~     child development, hence the need for formal screening. In the Arabic speaking population~     developmental screening tools are scarce in the native language and there is a need for such~     a tool for pediatricians and health care workers to use routinely.~      This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic~     (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally~     sensitive.~      The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then~     revised by experts in child development. Questionnaires will be adapted and field-tested on~     15 subjects per age group (total of 75). For validity, the revised version will be tested on~     500 Lebanese children (100 children per age group) selected from all Lebanese governates.~      It is expected to generate a culturally adapted and validated Arabic tool for screening~     children for any developmental delay up to 3 years of age. This tool once published will be~     available for use by primary care providers and caregivers in Arabic speaking countries. It~     may be used to screen children for developmental delay as early as 7 months therefore~     prompting prevention of further delay by starting early intervention and promoting child~     development.~   "
39476|NCT02539238|"~     Objectives: The primary objective of this project is to assess whether the implementation of~     a new cardiopulmonary resuscitation (CPR) training program (longitudinal training with~     real-time feedback) can improve CPR quality of healthcare providers compared with~     traditional training method. The secondary objective is to identify whether the~     implementation of the new training program will result in cost-effectiveness.~      Design: Randomized trial to compare new training program with tradition training method and~     cost-effectiveness alongside this trial~      Participants and setting: Paediatric healthcare providers in Emergency Department at Alberta~     Children's Hospital. Subjects will be enrolled in either intervention (new training program)~     or control (traditional training program) by random.~      Statistical analysis: Investigators will conduct chi-square test and independent t-test to~     compare the proportion of excellent CPR and 3 metrics of CPR quality of intervention group~     with control group at the end of 12-month interval. A multi-level logistic regression and~     linear regression models will be used to assess the effect of training method and time on~     proportion of excellent CPR and 3 metrics of CPR quality. Investigators will also conduct a~     full-economic evaluation in a health care system prospective. cost-effectiveness will be~     expressed as cost per increased CPR excellence according to incremental cost-effectiveness~     ratio (ICER). A one-way sensitivity analysis and a probabilistic sensitivity analysis will~     be conducted to deal with uncertainty in effects and costs.~      Conclusion: The new CPR training program will serve as an example of competency-based~     psychomotor skill training program and help healthcare providers to improve quality of CPR,~     and potentially improve the survival of children with cardiac arrest. The results of the~     studies might provide evidence to inform and update in resuscitation education guideline to~     change the way of CPR training and improve the cost-effectiveness of CPR training program.~   "
39477|NCT02539225|"~     The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with~     or without ramucirumab as first line therapy in participants with metastatic gastric or~     gastroesophageal junction (GEJ) adenocarcinoma.~   "
39478|NCT02539212|"~     According to randomized controlled trial requirement, the therapeutic effectiveness of~     cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular~     carcinoma is compared to find a better approach for minimally invasive thermal ablation.~   "
39479|NCT02539199|"~     The purpose of this study is to investigate the effectiveness and safety of vaginally~     administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in~     induction of labour in nulliparous women.~   "
39480|NCT02539186|"~     The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of~     musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for~     regeneration of peripheral neuropathy in animal study, the associated study in human is~     rare.~   "
39481|NCT02539173|"~     1. INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an~          inter-block scalénique varies between 30 and 100% in the literature. Its clinical~          impact is mostly absent and paralysis regresses after the block lifted. When it is~          suspected, it can be diagnosed by a chest radio, showing an elevation of the dome.~           The objective of this study is to evaluate the incidence of diaphragmatic paralysis by~          measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic~          contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit~          (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for~          the block under ultrasound scan.~        2. STUDY TYPE Prospective, single-center clinical study routine care involving 50~          consecutive patients scheduled to undergo surgical procedures in the area of the~          shoulder or arm for which locoregional analgesia inter-block type scalénique or~          supraclavicular ultrasound scan is indicated below.~        3. START OF THE STUDY February 2014 with an expected duration of six months.~   "
39482|NCT02539160|"~     Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events.~     Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD),~     which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet~     P2Y12 receptor inhibitor. However, despite its clinical benefit, patients with DM and CKD~     frequently experience recurrent atherothrombotic events. Ticagrelor is an oral, reversible,~     non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition~     than clopidogrel. In large-scale clinical investigation, ticagrelor significantly reduced~     ischemic events to a greater extent than clopidogrel, a finding that was consistent also~     among DM patients. To date there has been no analysis on the efficacy of ticagrelor in DM~     patients according to CKD status. Moreover, although PD studies showed enhanced platelet~     inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status.~     Ultimately, how PK/PD profiles of different ticagrelor dosing regimens may be affected by DM~     and CKD status is also unknown. The proposed study is aimed to show the impact of CKD status~     among patients with DM and CAD on PD and PK profiles of ticagrelor used at 2 doses (90mg bid~     and 60mg bid) in the setting of a prospective, randomized, cross-over trial.~   "
39483|NCT02539147|"~     Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate~     immune cells.~   "
39485|NCT02539121|"~     In this study, a single blind randomized trial with third party evaluation is carried out in~     order to compare the postpartum blood loss when Ren Mai 6 point is stimulated and when this~     point is not stimulated.~      Investigators focus on measuring the volume of postpartum blood during the third stage of~     labor and during the first two hours after birth. A significant reduction in the volume of~     bleeding would imply a reduction in the rate of postpartum hemorrhage (PPH) (more than 500~     ml) and the rate of severe PPH (more than 1000 ml).~      The principal outcome of the study is the volume of postpartum blood, this volume is~     measured by the midwife who is responsible of the birth. Collection of lost blood is~     initiated immediately after birth of the baby by passing a blood collection drape under the~     woman's buttocks.~      The secondary outcomes are the influence of acupuncture in the placental expulsion time, and~     the influence of the predictor variables in the bleeding volume and in the placental~     expulsion time: primiparity or multiparity, number of gestation including abortions, doses~     of oxytocin during labor, maternal age, maternal weight in the beginning of the gestation,~     maternal ponderal gain during pregnancy, date of the last blood test during pregnancy and~     value of hemoglobin and hematocrit, spontaneous labor or induction by means of oxytocin or~     prostaglandins, spontaneous or artificial rupture of membranes, first stage of labor~     duration, second stage of labor duration, hours since rupture of membranes, hours since~     epidural analgesia, volume of serotherapy during labor, and newborn weight. Possible~     puerperal complications or security problems, the degree of Satisfaction of the Mother and~     the degree of ease with which the acupuncturist administered the treatment are also~     secondary outcomes.~   "
39486|NCT02540551|"~     Recently the investigators have shown that the SN procedure performed through the injection~     of tracers into the ovarian ligaments is feasible and promising in patients with clinical~     early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the~     identification of SNs in all 21 patients. Before a multicentre prospective trial can be~     initiated, still some questions have to be answered, especially if a SN procedure still is~     feasable in patients with OC through injection of the tracers in the ovarian ligaments, when~     the ovarian tumour has already been resected, either during the same surgical procedure~     (ovarian tumour resected for frozen section with a malignancy as result) or at a second~     surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).~   "
39487|NCT02540538|"~     The purpose of this study is to determine whether the HBAI20 vaccine is safe and more~     immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis~     B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not~     have a protective anti hepatitis B antibody titer.~   "
39488|NCT02540525|"~     1. OBJECTIVE:~           To determine the efficacy and safety of a single-incision mini-sling compared with a~          transobturator midurethral sling for stress urinary incontinence (SUI) treatment.~        2. METHODS:~      This prospective single-center randomized controlled trial will involve 100 women with a~     diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as~     negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the~     Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form,~     operation time, complications, and reoperation rates were also recorded. The efficacy was~     analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P~     value >.05 rejects the noninferiority hypothesis of the mini-sling.~   "
39489|NCT02540512|"~     The purpose of the study is to test auricular (ear) acupuncture for the acute management of~     patient pain in the Emergency Department as an alternative and adjunct to standard medical~     treatment.~      Currently, physicians who practice medicine here in the United States only have~     pharmacological intervention at their disposal as the only available treatment tool they~     have for the treatment and management of pain, and as a result, painkiller misuse, overdose,~     and death has become the leading health epidemic in America. American healthcare is in~     desperate need of alternative and safer ways to prevent prescription painkiller overdoses~     and to better manage pain. If prescription painkiller dependencies can be avoided at the~     source, potentially many lives and healthcare dollars can be saved. Acupuncture is an~     alternative treatment that has been effectively used to treat pain for thousands of years in~     countries around the world. The National Institutes of Health (NIH) and the United Nations~     World Health Organization (WHO) have stated that acupuncture is a safe and effective~     treatment for the management of pain. Supported by many studies illustrating seventy-five to~     ninety-nine percent effectiveness in treating pain with an instantaneous drop in pain by~     twenty-five to eighty percent, acupuncture appears to be the safest and most effective~     option available to manage pain syndromes in the emergency department.~      Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain~     intensity. Specifically, for the thesis of this clinical trial, the investigators~     hypothesize that auricular acupuncture can be an effective alternative and/or adjunct~     treatment tool in the civilian emergency department for the acute management of pain.~      In order to test the safety and efficacy of using auricular acupuncture in the emergency~     department, people presenting to the emergency department with pain who are willing to~     participate in the study will be randomized into three separate groups:~        1. Standard medical group (tape on ear + standard medical drug)~        2. Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)~        3. Auricular acupuncture group (acupuncture + placebo pill)~      The design of these groups will allow the investigators to best test the efficacy of~     auricular acupuncture versus the placebo effect and standard medical care as well as an~     adjunct to standard medical care. To accomplish the objective of this proposal, the~     investigators will pursue the following specific aims:~      Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the~     management of pain syndromes. By having the acupuncture group and sham acupuncture group,~     the investigators will be able to effectively compare the difference in pain levels with a~     placebo-group.~      Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or~     adjunct to standard medical care in the Emergency Department.~      By testing the efficacy of acupuncture in conjunction with standard medical treatment, the~     investigators expect to see a potentiation of analgesic effects, and this will be noted by~     an increased reduction in pain between the standard medical plus acupuncture group versus~     the standard group and acupuncture group.~      Specific Aim 3: To prove that auricular acupuncture as an effective pain management~     alternative that decreases short-term prescription painkiller dependency.~      Through a series of follow up questionnaires and a medication diary that the investigators~     will give to the patient prior to discharge, the investigators will track the patient's need~     and use of additional pain medications post treatment. These surveys will give a good~     indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency~     on painkiller drugs in the short-term setting.~   "
39490|NCT02540499|"~     Despite considerable advances in cancer treatment, patients with locally advanced lung~     cancer still face a poor chance of survival and a high risk of experiencing serious, life~     threatening treatment-related side-effects. These side-effects are poorly understood and~     difficult to measure: it is therefore challenging to design new treatment strategies aiming~     to decrease treatment toxicity and yet increase survival. At present, many patients present~     with tumours so large that only a low palliative dose of radiation therapy can be offered in~     order to keep the risk of side-effects to an acceptable level. In this project, named~     INHALE, the possibility of irradiating lung cancer patients while they hold their breath in~     deep inspiration (so called: Deep inspiration breath hold, or DIBH) will be investigated. In~     DIBH, the healthy lung tissue is pushed away from the tumour, and even when a large tumour~     is present, a high curative dose of radiation therapy can be offered. This technique is~     simple and is widely used to treat breast cancer patients in our institution as well as in~     other centres in the world. If positive, results from INHALE can be transferred easily and~     with minimal costs throughout Denmark and the rest of the world.~      DIBH has only sporadically been used in lung cancer patients to date, because of the~     assumption that this patient group, often having a poor performance status, could not comply~     with DIBH procedure. However, the investigators' experience has shown that the majority of~     lung cancer patients can comfortably hold short repeated DIBHs during treatment sessions~     throughout the eight weeks of their treatment course, even if they have a relatively poor~     lung function.~      The differences in side-effects between patients treated with the INHALE regimen and a large~     group of patients previously treated at our institution will be thoroughly investigated,~     using both follow-up CT images and a range of clinical parameters. INHALE is a unique study~     because of combining use of the highest level of technology to ensure high-quality treatment~     in DIBH and a thorough scientific investigation of follow-up data. INHALE will provide an~     improved understanding of how to assess and decrease treatment side-effects: consequently~     the investigators aim to test the hypothesis in a large clinical trial in order to improve~     survival of lung cancer patients.~   "
39491|NCT02540486|"~     Evaluating patients with type 2 diabetes either starting once daily basal insulin or~     requiring increased basal titrations in order to compare the LTHome web based tool with the~     usual standard of practice for insulin glargine dosing adjustment.~   "
39492|NCT02540473|"~     Physicians in general are at risk for burnout, and this risk is heightened among women,~     particularly mothers. In a randomized design, central hypotheses in this study are that~     mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention~     will show significantly greater decreases in stress, depression, burnout, and associated~     risk biomarker indices, as compared to comparison controls (who would meet in unstructured~     gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize~     that the gains would be maintained three months after the intervention is completed.~   "
39493|NCT02540460|"~     The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371~     after a multiple oral dose in healthy male subjects.~      To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male~     subjects.~   "
39494|NCT02540447|"~     The investigators tested the impact of purging the graft contents and mesenteric blood into~     the systemic circulation versus washing out this volume out of the circulation in living~     donor liver transplantation recipients.~   "
39524|NCT02540057|"~     We are investigating the use of the flexor carpi radialis and abductor pollicis longus~     tendons in the use of trapeziectomy and ligament reconstruction with tendon interposition.~     Previous studies have shown clinical equipoise, and we plan to do a randomized controlled~     trial to further assess.~   "
39495|NCT02540434|"~     The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce~     allogeneic blood product use and decrease unnecessary laboratory costs. One of the NYPH~     Quality and Patient Safety Goals for 2013 was to improve the appropriate use of transfusion~     guidelines and reduce unnecessary red blood cell (RBC) transfusions. Further, this study~     will help to answer whether RiaSTAP is a more effective product to treat bleeding than~     cryoprecipitate. In addition, this trial will provide investigators with preliminary data to~     apply for future federal funding opportunities, such as the National Heart Lung and Blood~     Institute sponsored R21 grant (PAR-13-025) that encourages research grant applications from~     investigators who propose to study research topics in blood banking and transfusion medicine~     aimed at improving the safety and availability of the blood supply and the practice of~     transfusion medicine. The investigators anticipate future follow-on studies further~     investigating fibrinogen concentrate and other similar therapeutics in other perioperative~     populations, such as in postpartum hemorrhage or surgical ICU settings. Finally, this study~     involves the use of a safer therapeutic, fibrinogen concentrate, to improve patient care and~     patient safety. This product does not require the time-intensive process of thawing;~     therefore, delays in patient care can be avoided by having the product readily available in~     the OR.~   "
39496|NCT02540421|"~     Objectives: To identify factors associated with disease recurrence in patients with~     high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the~     transformation zone (LLETZ).~      Study Design: A case-control study that included 103 patients. Patients were included in the~     study if they had a history of surgery for conization by LLETZ for the histopathological~     diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).~     Follow-up exams were conducted every six months with Pap smear collection and colposcopic~     examination with biopsy, when necessary, for a minimum period of twelve months. Cure was~     defined as a normal follow-up examination within 24 months. During follow-up, relapse~     occurred when cytology and/or biopsy results showed that CIN had returned after 12 months,~     at which time a new cervical conization by LLETZ was performed.~   "
39497|NCT02540408|"~     A pilot study from the investigators group suggests that the prevalence of chronic~     obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general~     population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality~     of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial~     stiffness and exercise capacity) are largely unknown. Although immunization against organic~     dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.~      This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in~     subjects without any occupational exposure (control arm) through a vast COPD detection~     program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits,~     dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic~     inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and~     patients with COPD without any occupational exposure; (iv) identifying etiological factors~     of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy~     farmers with COPD and dairy farmers with normal pulmonary function tests); and (v)~     constituting a cohort of COPD patients and control subjects for further longitudinal~     studies.~      Data from selected patients (either current or former smokers) with mild COPD and from~     matched controls will also be analyzed in an ancillary study which objectives are to compare~     exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between~     asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.~   "
39498|NCT02540395|"~     The main objective of the study is to demonstrate the utility and safety of the IFN-γ~     (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification~     of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The~     enrichment study will test non-inferiority of low IS regimen compared to high IS regimen,~     assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit~     of maximum 10%.~   "
39499|NCT02540382|"~     Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in~     transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal~     hypertension.~   "
39500|NCT02540369|"~     To describe the use of intravitreal aflibercept in routine clinical practice and to describe~     follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical~     practice in Canada for a study population of treatment naive patients and those who have~     received prior therapy (anti-VEGF injections, laser, steroids, etc).~   "
39501|NCT02540356|"~     The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy~     given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after~     intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated~     dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with~     refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma~     pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will~     be explored in plasma and ascites. Two expansion cohorts will further assess the~     tolerability of the RP2D and explore clinical signs of efficacy.~   "
39502|NCT02540343|"~     The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain~     Questionnaire into German.~   "
39503|NCT02540330|"~     This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women~     scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast~     cancer or DCIS. The first subject of each of five groups will receive fulvestrant~     intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by~     intraductal instillation. All subjects will be monitored for systemic and local adverse~     events during the procedure, and following the procedure until mastectomy or lumpectomy.~     Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant~     blood concentration levels.~   "
39525|NCT02540044|"~     This proof-of-concept randomized trial evaluates the effectiveness of using an on-line~     decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in~     Canadian patients with rheumatoid arthritis.~   "
39714|NCT02537145|"~     The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in~     pregnant women to detect changes in health parameters by assessing compliance and user~     experiences of participants. Besides, the measured health will be analysed to increase~     insight in physiological development in pregnant women.~   "
39504|NCT02540317|"~     Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and~     cause substantial suffering. Prior evidence suggest that these disorders may be effectively~     treated with cognitive behavior therapy (CBT), but access to psychological treatment is~     limited. One possible solution is to provide therapy via the Internet, which has been shown~     to be effective for anxiety disorders and depression. In the present study, we will~     investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout~     syndrom in a randomized controlled trial (N=100). Participants will be randomized to active~     treatment (n=50) or a control condition on waiting list.~   "
39505|NCT02540304|"~     This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention~     (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an~     experimental design in which youth are randomly assigned to receive either TPP programming~     or services as usual.~   "
39506|NCT02540291|"~     This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and~     tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the~     recommended Phase 2 dose (RP2D) of E7046.~   "
39507|NCT02540278|"~     This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention~     program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.~   "
39508|NCT02540265|"~     The primary objective of this study is to evaluate the safety of N1539 in subjects with~     acute moderate to severe pain following unilateral bunionectomy.~   "
39509|NCT02540252|"~     Patients with non-traumatic lower limb amputation are characterized by; high age; majority~     being men; multimorbidity; and high mortality. The patients comorbidities are related to~     diabetes and cardiovascular disorders such as arteriosclerosis.~      Major surgery induces a surgical stress response that initiates a catabolic metabolism.~     Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and~     after amputation is high (3) as the most prominent indication for amputation is gangrene,~     followed by non-healing or infected wounds. This leads to an impaired immune response and an~     increased insulin resistance that also includes a cascade of impaired appetite regulation,~     low dietary intake and reduced nutrient uptake form the intestine which increases~     inflammation, loss of muscle and risk of severe complications.~      Among healthy adults with a normal weight a slow speed of eating will result in a low~     nutritional intake due to faster satiety experience.~      Low appetite following major surgery is related to the regulation of hormone controlling the~     appetite. Especially older patients experience variations in appetite that affect their~     eating pattern such as eating speed and intake. It is therefore reasonable to assume that~     the speed of eating and the total nutritional intake among older patients, who are exposed~     to catabolic metabolism, are associated.~      The hypothesis is that major surgery induces a change in patients' current eating pattern~     that is measurable and can be identified as a surrogate measurement of the catabolic state~     that is related to inflammation.~      Eating Patterns are often described in clinical practice without engaging in nutritional~     assessment of the patient. Whether the speed of eating is an objective marker of the current~     nutritional status has not been established.~      This study investigates patients undergoing lower limb amputation and their nutritional~     status, eating pattern and inflammation and whether this is linked to the current degree of~     disease. The purpose is to describe the development in nutritional status before and after~     amputation and to investigate associations between patients eating pattern and nutritional~     status to inflammatory and metabolic biomarkers reflecting the degree of disease.~   "
39510|NCT02540239|"~     To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S)~     for colonoscopy.~   "
39511|NCT02540226|"~     Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for~     Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is~     an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA~     can be given either intravenously or topically (placed directly on the open wound) before~     wound closure. Patients with certain medical conditions have been found to have a high risk~     of thrombosis after being given intravenous TXA, which may lead to serious complications.~     However, to date, no high-risk patients have been identified for use of topical TXA. This~     study will look at thrombogenic markers (proteins found in blood that promote clot~     formation) after TXA is given either intravenously or topically. If the effect on these~     markers is similar between intravenous and topical use of TXA, then the safety of topical~     TXA should be questioned. Of note, these markers have never been measured after TXA has been~     given topically. As a result, this information would be important for the medical community.~   "
39512|NCT02540213|"~     This non-interventional, observational study investigates the efficiency, safety and~     acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA)~     using a self-application system. For each participant, the investigator documents 9 months~     of treatment with Mircera with respect to efficacy, safety and acceptance.~   "
39513|NCT02540200|"~     Hip pain in young patients is difficult to diagnose and treat. However, with advanced~     imaging techniques and surgical method, the investigators are able to identify hip cartilage~     lesions as a cause for the hip pain. MR (magnetic resonance) arthrography is the best~     imaging modality to diagnose chondral lesions of the hip, but it occasionally miss the~     pathology, thus necessitating a more accurate and invasive means of diagnosis. Consequently,~     hip arthroscopy is increasingly used for both diagnosis and treatment for hip cartilage~     pathology.~      Microfracture is a means of stimulating bone marrow, and is a standard treatment for small~     chondral lesions. This procedure has shown to result in excellent functional and anatomical~     outcomes. Microfracture is now recognized as a standard treatment for cartilage lesions in~     the knee, and recently the indications of this technique extended to hip pathology.~      The BST-CarGel device (Piramal Life Sciences, Bio-Orthopaedic Division) is based on the~     patented technology for cartilage repair. BST-Gel comprised of the buffer~     beta-glycerophosphate and chitosan, which is a well-studied natural material that is~     biocompatible and appropriate for its use as a scaffold to assist in cartilage repair.~     BST-Gel is mixed with the patient's whole blood and delivered to a surgically prepared~     cartilage lesion in conjunction with bone marrow stimulation. The BST-CarGel/blood mixture~     solidifies in the cartilage lesion and provides a three-dimensional scaffold for the repair~     process. This product has shown to result in superior chondral lesion repair when compared~     to the bone marrow stimulation alone.~      The current study will collect data through standard of care practice when BST-CarGel in~     conjunction with a bone marrow stimulation technique is used for the treatment of focal~     cartilage lesions in the hip. In addition, these patients in the study group will be~     compared with the group o patients who undergo the bone marrow stimulation technique alone.~     The efficacy of BST-CarGel in conjunction with microfracture for cartilage lesions in the~     knee has been shown in previous studies. Additional research is required to expand knowledge~     and develop treatment guidelines for the treatment of the cartilage lesions in the hip using~     BST-CarGel. As the BST-CarGel improves the results of the bone marrow stimulation techniques~     without increasing the risks of the procedure, this device can be very beneficial in the~     case of cartilage lesions in the hip.~   "
39526|NCT02540031|"~     Although adequate bowel preparation is essential for successful colonoscopy, the 23% of~     patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in~     incomplete examination, increased patient's discomfort, decreased polyp detection rates,~     ultimately leading to repeated colonoscopies. One prior study showed that patients reporting~     their last rectal effluents as brown color or solid stool had a 54% chance of having fair or~     poor preparation. Thus, recent consensus guideline suggested consideration of additional~     oral preparation in patients presenting brown effluents on the day of colonoscopy. However,~     the data supporting additional oral preparation is still spares. Therefore, the~     investigators aimed to examine the impact of additional oral preparation on the quality of~     bowel preparation for colonoscopy in patients showing brown effluents on the day of~     colonoscopy.~   "
39527|NCT02540018|"~     The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor®~     paclitaxel drug‐eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting~     restenosis and in ensuring long‐term patency.~   "
39514|NCT02540187|"~     Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic~     mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible~     for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a~     factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX)~     deficiency. According to the intensity of the defect, there are three forms of haemophilia:~     severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor~     (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic~     manifestations are variable from one patient to the other. Moreover, several studies showed~     that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that~     haemophilic A patients.~      The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin~     system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive~     inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation~     starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the~     VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the~     amplification pathway being strongly altered because of factor VIII or IX deficiency,~     thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We~     can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI~     that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.~   "
39515|NCT02540174|"~     This is a multicenter, interventional, randomized study among patients with a first lung or~     head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to~     compare the systematic implementation of an addiction treatment program initiated at~     hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual~     procedure, which consists in recommendations to follow an addiction treatment program (Arm~     B)~   "
39516|NCT02540161|"~     The purpose of this study is to assess the activity of Sym004, a recombinant antibody~     mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma~     whose tumor is EGFR amplified. This is a phase 2 study that will accrue a total of 61~     patients with WHO grade IV recurrent malignant glioma (glioblastoma or gliosarcoma) in two~     cohorts to assess the efficacy of Sym004.~   "
39517|NCT02540148|"~     This randomized study will assess the effectiveness of externally applied micro current~     electrical stimulation on improving the visual acuity in subjects with vision loss from dry~     (non-neovascular) age-related macular degeneration (AMD) over a 6 week period.~   "
39518|NCT02540135|"~     This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance~     Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of~     tumor tissue during surgery.~      Both fluorescein and intraoperative MRI have been studied and routinely used to aid the~     neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely~     resect more tumor tissue during surgery.~      This study will enroll patients with malignant high grade glioma who are going to have a~     surgery to remove their brain tumor.~      For half of the patients, fluorescein and intraoperative MRI will be used together during~     surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI~     is used as final verification of complete, safe resection in both arms.~   "
39519|NCT02540122|"~     This is a pilot evaluation to assess the feasibility of using novel imaging process to~     characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and~     blink; and conjunctival microvasculature including fractal analysis of microvascular~     perfusion maps and blood flow velocity.~   "
39520|NCT02540109|"~     This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment~     of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as~     alternate outcome measures, subject selection criteria, and benefits of extended treatment~     duration. These results will be compared to an existing trial using conventional~     non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS~     while performing computerized anomia treatment. The basis behind this method is that~     language therapy is mediated by cortical areas that are most effectively activated during~     the training tasks, thus increasing electric stimulation in these areas may improve learning~     outcomes. To better understand the long term benefits of the adjunctive treatment, patients~     will be screened again four weeks and six months after study using the same anomia tests. If~     HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a~     Phase III trial can be considered.~   "
39521|NCT02540096|"~     Stroke is a neurovascular event characterized by impaired blood supply to the brain due to~     rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and~     can affect individuals of any age and sex, being prevalent in the elderly population.~      Among the main treatments available for stroke rehabilitation, most of them demands an~     appropriate structure and high-qualified personnel. Searching for more affordable treatment~     options, several studies suggest the use of mental practice with motor imagery as a~     potential therapeutic tool, since it can be performed at any place or any time the patient~     wishes, including their own homes.~      Motor imagery can be defined as the covert cognitive process of imagining a movement of your~     own body(-part) without actually moving that body(-part).~      Within this context, the objective of this study is to investigate the effects of mental~     practice for mobility, gait function and speed and muscle strength of the lower limb in~     subacute post-stroke hemiparesis.~   "
39522|NCT02540083|"~     The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on~     both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along~     with other subject data including histology results from biopsy specimen examination and~     cancer classification data from initially asymptomatic women referred for clinically~     indicated breast biopsy based on suspicious DBT screening breast imaging results. These data~     will be included in a subsequent and prospectively planned pooled analysis described in a~     separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer~     diagnosis and other performance measures.~   "
39523|NCT02540070|"~     Patients undergoing primary total knee replacement will receive either motor sparing knee~     block to be performed by anesthesia or periarticular local anesthetic infiltration at the~     end of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The~     motor sparing knee block will be performed prior to surgery using ultrasonography and the~     effect of adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to~     prolonging the duration of analgesia will be assessed.~   "
39528|NCT02540005|"~     The main purpose of this study is to analyse the on-going coagulation process after aSAH.~     For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a~     point-of-care test using a variety of activators to provide a targeted and a dynamic~     analysis of coagulation cascade. This is a prospective, observational clinical study done in~     16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control~     patients (elective craniotomy due to non-ruptured intracranial aneurysm.~   "
39529|NCT02539992|"~     Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement~     (TKR) in a consecutive series of patients who meet the eligibility criteria.~   "
39530|NCT02539979|"~     A double blinded randomized controlled study comparing pre-procedural IV Paracetamol versus~     IV placebo (normal saline). The patients will be randomized to either receiving IV~     paracetamol or saline infusions before undergoing radiofrequency lesioning of two levels of~     medial branch nerves of the lumbar facets. The primary outcome will be potential differences~     in pain control. The secondary outcomes will be changes in quality of life (QoL) and~     activities of daily living (ADLs). We will also be comparing potential differences in the~     amounts of post-procedure pain medications taken by the patients in each wing of the study~   "
39531|NCT02539966|"~     The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable~     Coronary Scaffold in native coronary arteries.~   "
39532|NCT02539953|"~     One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure.~     The investigators intend to monitor the ambulatory blood pressure of such patients in order~     to assess whether this is a true haemodynamic effect.~   "
39533|NCT02539940|"~     The aim of this observational study is to evaluate the outcomes and safety of the~     Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease~     (PAD) in below-the-knee vessels~   "
39534|NCT02539927|"~     Patients will be treated in accordance with the standard medical practice of the hospital~     where they have been recruited during their participation in this study. No additional~     assessments or tests will be required.~      SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing~     endocrinologists to manage acromegalic patients and disease activity in their clinical~     practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S;~     Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth~     factor 1(IGF-1) concentration -I; Tumour size- T.~      The instrument has been pre evaluated during a qualitative pilot study. The purpose of the~     validation study is to define and validate the scoring of the SAGIT® instrument.~   "
39535|NCT02539914|"~     The purpose of this study is to determine whether it is feasible to use a virtual reality~     task for stroke rehabilitation for training motor and cognitive (attention and memory)~     domains based on the use of positive stimuli, and to evaluate the potential benefits in~     comparison to standard rehabilitation.~   "
39536|NCT02539901|"~     Cochlear implantation enables profoundly deaf children to acquire speech and develop their~     understanding of spoken language. However, there are significant interindividual differences~     in the results obtained with the implant. Given the lack of theoretical knowledge on~     acoustic predictors, cognitive and language to obtain optimum speech recognition with~     cochlear implants associated with a good communicative and language development of deaf~     children, the investigators intend to achieve a preliminary longitudinal study aimed to~     describe the cognitive, communicative and perceptive implanted deaf children.~      The main objective of our study is to describe the cognitive and communicative development~     of deaf children implanted from the pre-implant assessment to 18 months post-implantation,~     by addressing the following aspects:~        -  The psychomotor and cognitive development assessed using the Brunet-Lézine test;~        -  The development of preverbal communication, evaluated using the Early Social~          Communication Scale.~   "
39537|NCT02539875|"~     Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily~     smokers 10.8% (Census and Statistics Department, 2013) and half will be killed by smoking~     (Lam, 2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto,~     2001). Smoking also accounts for a large amount of medical cost, long-term care and~     productivity loss of US$688 million (0.6% Hong Kong GDP) (Census & Statistics Department,~     2001; McGhee et al., 2006) . Smoking is a highly addictive behavior and it is difficult for~     smokers with strong nicotine dependence to quit without assistance. On the other hand,~     reaching and helping the many smokers who have no intention to quit is a challenge, because~     they are unlikely to seek professional help from smoking cessation services.~      The Quit and Win programme provides an opportunity to reach and encourage a large group of~     smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that~     smokers participating in the contest will have higher motivation to quit with incentives and~     better social support (Cahill & Perera, 2011). Studies have found that such quitting~     contests or incentive programs appeared to reach a large number of smokers and demonstrated~     a significantly higher quit rate for the quit and win group than for the control group~     (Cahill & Perera, 2008).~      Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult~     daily smokers who had never used smoking cessation services (Census and Statistics~     Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing~     services mostly require self-initiation to seek the services but smokers general lack the~     will power of initiation. Active referral will help overcome the barriers of~     self-initiation. There is preliminary evidence that active referral of smokers to smoking~     cessation hotline services may increase likelihood of smoking abstinence at 12-month~     follow-up compared with no active referrals (Borland et al., 2008). A recent study has also~     reported that individuals who used the community-based referral were also more likely to~     quit than those who did not (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).~      Therefore, the present study will examine (1) effectiveness of the active referral and AWARD~     approaches, (2) explore the use of CBPR model to build capacity and to engage community~     partners in taking on this important public health issue for sustainability in the~     community. In addition, process evaluation will be conducted to assess the effectiveness of~     the recruitment activity and how it is linked with the overall program outcomes.~   "
39538|NCT02539862|"~     The purpose of this study is to evaluate the effectiveness of the management of chronic~     primary insomnia patients by a computer program guidance of behavioral and cognitive~     therapies for insomnia (BCT-I).~   "
39539|NCT02539849|"~     FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's~     disease~   "
39561|NCT02539550|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     PF-06266047 after first-time administration to healthy adult subjects.~   "
39562|NCT02539537|"~     French national multicentric phase III trial evaluating chemotherapy with Folfirinox or~     gemcitabine in locally advanced pancreatic carcinoma~   "
39563|NCT02539524|"~     The aim of this study is to investigate weather the breathing exercises of Yoga are~     effective in altering clinical impact, anxiety, depression and quality of life in Chronic~     Obstructive Pulmonary Disease patients.~   "
39715|NCT02537132|"~     The purpose of this study is to demonstrate that the adaptation to the Non Invasive~     Ventilation (NIV) at home is not worse when compared with an adaptation performed in~     inpatient settings.~   "
39540|NCT02539836|"~     With the rapid development of society and economy, children's simple obesity is the rising~     in the world and has become a chronic disease which is one of the biggest public health~     challenges in the world. It is a serious threat to the health of children and their~     adulthood. The overweight and obesity is induced by the genetic and environmental factors.~     The environmental factors are very important, while the dietary factors are the driving~     factors of many chronic diseases including obesity. This study focus on the dietary~     intervention of childhood obesity to build healthy intestinal flora. The interventing food~     was based on a natural health food - fruit and vegetable fermentation liquid, and combined~     with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation~     of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese~     children and normal children, and to construct healthy micro environment of intestinal flor.~     According to the positive effect factors, the study will propose a healthy diet and~     nutrition intervention model for obese children, which is significant to social health~     especially to children's health.~   "
39541|NCT02539823|"~     Despite the current available therapies for opioid-dependent patients, most patients~     relapse. This research project focuses on the development of a novel compound, cannabidiol,~     to modulate opioid craving in humans based on animal models showing its selective~     effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for~     opioid relapse would be of tremendous medical and public health value.~   "
39542|NCT02539810|"~     The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded~     endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting +~     standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration~     in patients with confirmed resistant hypertension (RH) and angiographically proven grade III~     unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.~   "
39543|NCT02539797|"~     This study will examine the benefits of transcranial direct current stimulation (tDCS), a~     new tool that is being developed as a safe and non-invasive neurostimulation method, for~     improving neurocognitive and social cognitive functions in schizophrenia. This procedure is~     non-invasive and painless and it results in increase or decrease of spontaneous neuronal~     firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in~     healthy individuals and several clinical populations. In this pilot study, the investigators~     will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia.~     Each participant will arrive for three visits, with approximately one week between each~     visit. During the first visit, participants will be interviewed about their psychiatric~     symptoms, personal life experiences, and emotional well being by a specially-trained~     interviewer. On each of the three visits, participants will receive one of three~     stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of~     tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current).~     Immediately following the stimulation, participants will be asked to complete measures of~     mental abilities, including tests presented on a computer screen and paper-and-pencil tests.~     During each visit, participants will also undergo a standard measure of brain activity (EEG)~     while listening to tones. The first visit will last approximately five hours, and the other~     two visits will last approximately four hours each. The project will take approximately two~     years to complete.~   "
39544|NCT02539784|"~     Following the so call honey moon period, motor symptoms of Parkinson's Disease (PD) become~     difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the~     subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian~     patients restoring a decent quality of life. However, DBS need a long, complex and invasive~     surgery to succeed. Thus, there is a critical need to develop alternative treatments, more~     accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for~     decades to treat chronic neuropathic pains. Safety and efficacy have already been~     demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve~     locomotor activity in two different rodents' models of parkinson's disease. The purpose of~     this study is to determine whether thoracic SCS is safe and could induce a benefit motor~     parkinsonian symptoms without any impact on cognitive function and axial disability.~   "
39545|NCT02539771|"~     Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in~     adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea~     syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep~     Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations~     (nocturnal desaturation) favour nocturnal VOC.~      The confirmation of this hypothesis will lead investigator to propose a systematic screening~     of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic~     treatment of OSA in sickle cell patients could help significantly reduce the number and~     severity of nocturnal VOC.~   "
39546|NCT02539758|"~     Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma.~     The effect of ocular massage on intraocular pressure in patients with acute primary angle~     closure was the important thing.This was a prospective study, in which 20 eyes from 20~     patients had acute angle closure. When they went to the hospital, ocular massage was~     performed without any medication. Intraocular pressure was detected by Goldmann tonometer,~     and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and~     after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were~     observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also~     checked by gonioscope after massage.~   "
39547|NCT02539745|"~     This study investigated whether vitamin D receptor gene polymorphism is altered in primary~     open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an~     important factor in the development of glaucoma. Primary open-angle glaucoma patients and~     age-matched people in the Han population were enrolled. Serum levels of 1a,~     25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. Vitamin D~     receptor polymorphic analysis was studied by real-time polymerase-chain reaction high~     resolution melting analysis.~   "
39576|NCT02538965|"~     To determine the activity of lenalidomide in the treatment of pediatric subjects with~     relapsed/refractory AML (with second or greater relapse or refractory to at least 2 prior~     induction attempts) measured by morphological complete response defined as either a CR or~     CRi within the first 4 cycles of treatment.~   "
39548|NCT02539732|"~     Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a~     patient is ready to be weaned from the ventilator based on breathing pattern measurements.~     The T-piece technique allows clinicians to calculate breathing patterns accurately but many~     prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern.~     The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt)~     supposedly represents what the patient really wants: without disconnecting the patient from~     the ventilator, it may be possible to determine what is the real need and whether the~     patient is able to maintain Vt without support. The aims of the study are as follows: to~     test whether the changes in Vt after the removal of a standardized level of NAVA assistance~     (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA~     (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the~     Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular~     pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of~     PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at~     least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18~     years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical~     patients expected to be extubated within 12 hours will be excluded. After a baseline~     inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level~     will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution~     (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive~     Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both~     with NAVA gain 0) will be performed in order to record the difference with Vt during~     standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the~     baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT~     with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide~     whether or not to extubate the patient according to standard criteria and blinded to the ΔVt~     results. Ultimately, patients will be classified as success or failure and the ΔVt will~     be compared between these two groups.~   "
39549|NCT02539719|"~     This is a Phase 1a/1b study of SC-003 in patients with platinum-resistant/refractory ovarian~     cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked~     to a potent chemotherapy.~   "
39550|NCT02539706|"~     This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half~     of participants will receive follicular phase, while the other half will receive luteal~     phase.~   "
39551|NCT02539693|"~     Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as~     well as in the recovery room. In addition, decreased hospital stay and postoperative~     analgesic consumption.~      Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it~     would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine~     versus 150µg/mL.~   "
39552|NCT02539680|"~     The aim of the present study is to study the expression of the various phosphate~     transporters in patients with normal or moderately impaired renal function or in patients on~     dialysis. In particular, the investigators want to clarify whether NaPi-IIb expression level~     decreases in CKD patients, which would render it a potentially inadequate pharmaceutical~     target in these patients.~   "
39553|NCT02539654|"~     The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic~     Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,~     immediately after bilateral tympanostomy tube surgery.~   "
39554|NCT02539641|"~     The study evaluates the gastric emptying by scintigraphy in patients that had bariatric~     surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight~     loss and in patients before and after the placement of a duodenal-jejunal bypass liner.~      Additional, after bariatric surgery gut hormones that influence the gastric emptying rate~     are determined.~   "
39555|NCT02539628|"~     The investigators believe sufficient spread to all nerves within the adductor canal—and~     thereby sufficient analgesia—can only be obtained by bolus injections and not by continuous~     infusions via a catheter. The aim of the study is to investigate whether an adductor canal~     block performed as repeated intermittent boluses provides superior pain relief to continuous~     infusion. The investigators hypothesize that adductor canal block performed as intermittent~     boluses via a catheter will reduce morphine consumption and pain as well as enhance~     ambulation and muscle strength compared with continuous infusion.~   "
39556|NCT02539615|"~     The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for~     the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology.~     Including collecting, processing and shipping samples, training staff, processing samples,~     sample interpretation and accurate and timely reporting in a manner resembling routine~     clinical use. The study will include a subset of patients who are known carriers of a BRCA~     germline mutation. NAF from this subset will be submitted for molecular testing in addition~     to cytology.~   "
39557|NCT02539602|"~     This trial evaluated the impact of N2K, a three-year quasi-experimental study to delay~     sexual initiation and increase condom and contraception use among high school students. The~     program was administered to treatment students beginning in the fall of 2012 (9th grade) and~     continued through the spring of 2015 (11th grade). The purpose of this study was to measure:~     1) the impact of N2K on sexual initiation at the end of the three-year program and 2) the~     impact of N2K on condom or contraception non-use at the end of the program.~   "
39558|NCT02539589|"~     The purpose of the study is to determine the impact of the offer to participate in Becoming~     a Responsible Teen (BART) (treatment) relative to the offer to participate in Healthy Living~     (control) on two self-reported sexual behaviors (condom use and frequency of sex) six months~     after the end of treatment.~   "
39559|NCT02539576|"~     The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg~     fixed-dose combination (FDC) tablet is currently approved in the United States (US) and~     Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC~     tablets have been extensively studied in subjects not of Japanese heritage, these parameters~     have not been exclusively assessed in Japanese subjects. To support the marketing~     application in Japan, this single-dose, open-label study will characterize the PK, safety~     and tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of~     12 subjects will be enrolled such that approximately 10 evaluable subjects complete the~     study. The study will consist of a screening, treatment phase (single oral dose under the~     fasted state) and follow-up visit (within 7-14 days of the last PK sample collected). The~     total duration of the study for each subject will be approximately up to 48 days.~   "
39560|NCT02539563|"~     Labor patients who meet inclusion and exclusion criteria will be consented to be participate~     in this study to determine if the use of a peanut shaped birthing ball reduces the length of~     labor and reduces the incidence of cesarean section. Subjects will be randomized at the time~     of consent to either use the birthing ball or not use the birthing ball from the time of~     labor analgesia until complete cervical dilation.~   "
39716|NCT02537119|"~     Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with~     nonspecific low back pain.~   "
39564|NCT02539511|"~     Alcohol use disorders remain a significant public health problem. The pharmacological~     facilitation of behavioral treatment represents a promising strategy for addressing~     disordered drinking. Alcohol use disorders are recognized to be associated with various~     vulnerabilities that complicate the course of treatment and that may be amenable to~     glutamate modulators. The purpose of this randomized, double-blind, controlled trial is to~     test various glutamate modulators in conjunction with motivational enhancement therapy (MET)~     for alcohol use disorders.~   "
39565|NCT02539108|"~     The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of~     Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with~     the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6~     months to < 9 years of age.~      Objective:~        -  To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit available sera from each subject to Center for Biologics Evaluation and~          Research (CBER) for further analysis by the World Health Organization (WHO), the~          Centers for Disease Control and Prevention (CDC), and the FDA to support formulation~          recommendations for subsequent influenza vaccines.~   "
39566|NCT02539095|"~     The primary objective of this study is to confirm the superiority of intra-articular~     collagen injection in patients with knee joint pain compared to the control group. 100mm VAS~     is used to measure the pain of the subjects 24 weeks after the procedure.~   "
39567|NCT02539082|"~     The primary objective of this study is to evaluate the safety and efficacy of collagen~     injection in patients with plantar fasciitis~   "
39568|NCT02539069|"~     A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous~     cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and~     safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.~   "
39569|NCT02539056|"~     A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous~     cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects~     in their knees.~   "
39570|NCT02539043|"~     The aim of this study is to evaluate the effect of cavitation ultrasound focused on~     localized adiposity and its effects associated with stereodynamic lymphatic drainage. The~     investigators aim also to know if this procedure will influence the biochemical profile of~     the individuals concerned, as well as whether it will be found difference between the group~     that will receive focused ultrasound cavitation associated with stereodynamic drainage and~     the group will receive only focused cavitation ultrasound.~   "
39571|NCT02539030|"~     This study was designed to evaluate the efficacy and safety of a modified microfracture~     using collagen, and to compare them with those of a simple microfracture to prove the~     non-inferiority of the modified microfracture using collagen in patients with cartilage~     defects in their knees.~   "
39572|NCT02539017|"~     As a special type of breast cancer, the triple negative breast cancer has the~     characteristics of high recurrence rate (2 years after surgery), high distant metastasis~     rate, poor prognosis and short survival time. No matter at home or abroad, the clinical~     researches of the triple negative breast cancer are mainly focused on finding new drugs and~     new treatment strategies in order to reduce its recurrence and distant metastasis rate. The~     DC/CIK cell immunotherapy combined with chemotherapy in the clinical study of metastatic~     triple negative breast cancer has already confirmed benefit. This study is based on the~     theory that the optimal timing of cellular immunity is while the host tumor load is under~     the smallest state. Put forward the hypothesis that the DC/CIK cell immunotherapy combined~     with chemotherapy may improve the disease-free survival and overall surviva after the triple~     negative breast cancer operation. The investigators intends to use the RCT, observing the~     clinical significance of cellular immune adjuvant therapy of triple negative breast cancer~     in 340 patients with TNBC. Do the safety evaluation of cellular immunity in the adjuvant~     treatment of breast cancer treatment, explore the clinical strategies for breast cancer~     immunotherapy.~   "
39573|NCT02539004|"~     Urolithiasis is a universal problem, a large part of patients will be affected by multiple~     stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years.~     The high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT~     real-time fusion (Fusion) enables lesion assessment and follow up using both modalities as~     reference for each other. Our study proposes a novel approach for short term follow up of~     patients using Fusion instead of repeat NCCT exams.~      the goal of the study is to create an initial proof of concept that Fusion is effective for~     follow up of known urinary stones.~      the study is a prospective study on Patients with an obstructing ureteral stone found on a~     NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary~     endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as~     a Road Map.~   "
39574|NCT02538991|"~     One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary~     incontinence is physical activity-related stress urinary incontinence (SUI). If the~     first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment~     options are suburethral sling operation or transurethral bulking injection. Randomized~     studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient~     satisfaction is missing.~      This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI.~     Main outcome measures are patient satisfaction, complications and effectiveness of the~     treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness,~     pain during and after treatment and changes in Quality of Life and symptoms.~   "
39575|NCT02538978|"~     This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal~     clinical study in which subjects are evaluated for prevention of major limb amputation in~     the treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI).~     Subjects will be randomized in 3:1 ratio (device treatment: placebo-control).~   "
39717|NCT02537106|"~     Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and~     microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and~     natriuresis is less pronounced.~   "
39577|NCT02538952|"~     Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB~     diagnosed late in the course of disease is thought to be the most common cause of death~     among HIV-infected persons.~      Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has~     a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy~     (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly~     rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV~     care and treatment clinics. To maximize impact of the Xpert device in improving detection of~     active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1)~     adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB~     case-finding nurses in facilities; and (3) training health facility personnel in TB~     diagnostic algorithms. The combination of these strengthened TB screening procedures and~     rollout of the Xpert device is referred to as the Xpert package in this protocol.~      Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the~     new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees~     is more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing~     culture-positive TB disease; and (2) to evaluate the impact of the whole Xpert package on~     all-cause mortality during the first 6 months of ART, among adult patients.~      Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were~     prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131~     persons was also enrolled to meet the second objective. Projected power to meet both~     objectives is >80%.~      Time line: Prospective cohort enrollment started in July 2012 and was complete by March~     2014. Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data~     entry will be complete in March 2016 at which time analysis to answer the first two primary~     study questions will be possible.~   "
39578|NCT02538939|"~     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.~     US- guided needling and lavage of the calcification is one of the therapeutic options after~     failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal~     of this procedure is to remove the calcific deposit that is believed to cause the~     sub-acromial impingement. However, studies have shown that complete and rapid disappearance~     of the calcification deposit after irrigation is rare. The treatment is thought to promote~     the spontaneous resorption that occurs the weeks and months after the procedure. However,~     due to this slow process, time to complete recovery can be long. Moreover, it has been shown~     an association between the amount of removed calcium and improved outcome. Therefore, there~     is a need to find a way to remove quickly and completely the calcific deposit after~     irrigation. Sodium thiosulfate has been used successfully in the treatment of calciphylaxis~     and subcutaneous calcification deposit. The mechanism of action involves chelation of~     calcium into calcium thiosulfate salts which are much more soluble than other salts of~     calcium. Our hypothesis is that injection of sodium thiosulfate after irrigation of the~     calcification will help to dissolve the calcific deposit and thus prompt the disappearance~     of the calcification.~   "
39579|NCT02538926|"~     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,~     cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients~     with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy,~     such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Asparaginase~     breaks down the amino acid asparagine and may block the growth of tumor cells that need~     asparagine to grow. Giving combination chemotherapy with asparaginase may work better in~     treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.~   "
39580|NCT02538913|"~     Cancer treatments often cause acute toxicity during treatment, and late toxicity after~     treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction~     are late side effects associated with cancer treatment in general, and patients treated for~     pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329~     in 2010. Advances in the treatment during the past few decades have led to fewer local~     recurrences and increased long-term survival, and today the relative survival is 66% for~     women and 64% for men. More patients are having sphincter-preserving surgery with low~     colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70%~     of the patients with curative surgery. Unfortunately, many patients experience altered bowel~     function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal~     incontinence are common and distressing complications. These functional disturbances are~     seen in up to 50-60% of the patients, and most frequent when surgery is combined with~     neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in~     both men and women following rectal cancer treatment.~      In many surgical settings, patients with higher preoperative physical fitness rehabilitate~     more quickly and have fewer operative complications compared with patients who are less~     physically fit. Additionally, specific strength training of the pelvic floor muscles builds~     up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and~     closes the levator hiatus thus providing improved structural support for the pelvic floor as~     well as more optimal automatic function. The aim of the present trial is to investigate~     whether exercise training including pelvic floor muscle training during preoperative~     radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the~     physiology of the anal sphincter muscle after LAR. In addition quality of life,~     cardiopulmonary parameters and postoperative complications will be studied.~   "
39581|NCT02538900|"~     This proposed study will determine whether an exercise intervention that avoids continuous~     supervision and exercise-related ischemic pain improves walking performance at 52-week~     follow-up in people with PAD. Our intervention directly addresses two aspects of current~     practice guidelines that are major barriers to exercise for patients with PAD: 1) the~     recommendation for supervised exercise and 2) the recommendation for high intensity~     ischemic-pain inducing walking exercise.~   "
39582|NCT02538887|"~     The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection~     System (RFDS) as a non-radiological means to ease the process of detecting retained sponges~     and reconciling sponge counts in the labor and delivery room (following vaginal birth).~   "
39583|NCT02538874|"~     The purpose of this study is to assess safety, to measure blood levels of drug, and to find~     out what the drug does to the body.~   "
39591|NCT02538770|"~     Viral respiratory infections are common and often require use of health care resources.~     Patients receive inappropriate bacterial antibiotics, which has many problems including~     side-effects, development of resistance and costs.~      A small portion of the infections leads to severe clinical manifestations including~     hospitalisations and deaths. The significance of influenza virus is well known and it is~     actively detected in all age groups. However, the benefits of detecting other respiratory~     viruses have mainly been studied among children but not among adults. The development of~     multiplex PCR technique has provided a new and sensitive method for diagnosing a large panel~     of viruses. To convince the economical benefits of the rapid viral diagnostic in adult~     infectious patient, more evidence is needed.~      In our randomized study, nasal and pharyngeal samples from the patients evaluated at the~     emergency clinic of internal medicine in the University Hospital of Oulu because of any~     respiratory symptom, chest pain or fever, will be collected. The samples will be tested for~     16 different respiratory viruses by using Anyplex TMII RV16 Detection. The adult~     participants will be randomized in two groups. In one group the results of the testing will~     be reported for the attending physician as soon as possible, and in the other group 7 days~     after sampling. The effect of this delay to patient care is monitored. Also the results of~     children and adults are compared as well as results of men and women. The hypothesis is that~     rapid viral diagnostics shortens the length of admission and diminishes the use of bacterial~     antibiotics. New information on the viral epidemiology among children and adults is provided~     and clinical manifestations of specific viral infections in adults are described.~      The estimated 1500 samples are also tested for 5 different respiratory bacteria by Anyplex~     TM II RB5 Detection. These results will be examined after completion of the study period.~     The benefits of rapid bacterial detection are evaluated in respect to the clinical course of~     the disease and considering the infection control aspects as well.~   "
39584|NCT02538861|"~     This is a prospective open label two arms clinical trial. ARM-A patients will receive the~     standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single~     Photon Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized~     sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial~     perfusion with new Revolution CT scanner (General Electric Healthcare) while the Group-2~     will receive SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital~     (WKBH). The primary hypothesis is that the combined evaluation of CT angiography with CT~     myocardial perfusion is more efficient in detecting or excluding acute coronary syndrome~     resulting in early discharge and decrease length of stay of patients from the Emergency~     Department (ED) compared to a strategy with SPECT alone. The secondary hypothesis is that a~     strategy with CTA/CTP can reduce direct patient care costs and potentially improve patient~     outcomes in the same patient population when compared to a strategy with SPECT imaging~     alone.~      The main purpose of this study is to have a definite ED chest pain admission triage, which~     will help to reduce the length of stay and direct patient cost. This approach will reduce~     the economic burden in intermediate risk group patients as well. We had a Baptist~     statistician run the numbers. This study will provide important preliminary data to guide~     clinical implementation of CTP/CTA in clinical practice. We divided arm B into two groups as~     the CT protocol might be different at each hospital, so we want to reduce bias as a result~     of variation in clinical patterns in the different hospitals. Also, we kept 50 patients in~     arm A (Baptist hospital) to have a control group at the hospital level.~   "
39585|NCT02538848|"~     To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in~     healthy volunteers~   "
39586|NCT02538835|"~     This study evaluates the effect of metacognitive group therapy on depression compared to~     mindfulness groups and supportive groups. The participants, all with a history of depression~     and with current symptoms of depression, will be randomized to one of the three group~     interventions.~   "
39587|NCT02538822|"~     Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life~     by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At~     present, the only parameter for assessing the risk of complication is the maximum diameter~     of the aneurysm. The only way to avoid a complication is a surgical replacement of the~     aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with~     extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is~     indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous~     aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or~     Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the~     surgical threshold which remain stable. Conversely, complications have been described for~     aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as~     inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple~     methods have been described in the literature. One of them relies on in vitro mechanical~     testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging~     (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of~     complication better than the universally used criterion of diameter.~      The pathophysiology of these aneurysms has also been explored from histological studies. The~     investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated~     with a degradation of elastin fibers and collagen that determine to a large extent its~     biomechanical behavior. Histological analysis appears inseparable from biomechanical~     analysis.~   "
39588|NCT02538809|"~     Bladder cancer is a well-recognized complication in spinal cord injury (SCI) individuals.~     The observed incidence rates in SCI individuals are considerably higher compared to the~     general population. Bladder cancer in SCI individuals tends to present at an earlier age~     compared to the general population. Furthermore, bladder cancer in SCI individuals is more~     commonly invasive and at a more advanced stage at the time of diagnosis compared to bladder~     cancer in the general population. Individuals with bladder cancer commonly present with~     hematuria and other urinary symptoms. The gold standard for diagnosis is cystoscopy. However~     in SCI individuals, hematuria may get attributed to catheter irritation or trauma or an~     urinary tract infection. Furthermore, the bladder wall commonly presents with various~     changes under cystoscopic examination masking the presence of a bladder wall mass. Thus,~     diagnosis of bladder cancer in SCI individuals can be complicate.~      Some cytokeratins are frequently overexpressed in tumor cells and are therefore a marker of~     bladder cancer. There is a new commercial test available for the quantitative measurement of~     cytokeratins. The diagnostic accuracy of this test has been investigated in non-SCI~     individuals with symptoms suspicious for bladder cancer. The test showed high sensitivity~     and specificity values and is thus a promising diagnostic or screening tool. However, the~     diagnostic accuracy of the test has not yet been investigated in SCI individuals.~      The primary objective of the proposed study is to investigate whether urine cytokeratin~     levels in spinal cord injury individuals with symptoms and findings suspicious for bladder~     cancer are a discriminator between individuals suffering from bladder cancer and those not~     suffering from cancer.~      Individuals presenting with symptoms suspicious of bladder cancer will undergo ultrasonic~     and cystoscopic examination of the bladder. An urine sample will be taken, and the bladder~     will be flushed for collecting a bladder fluid sample. In patients with bladder wall~     findings suspicious of cancer, a bladder wall biopsy will be taken, according to clinical~     standard practice. The bladder fluid and the bladder wall biopsy will be submitted for~     cytology and histopathology examination, respectively. Cytokeratin levels will be measured~     in the urine sample.~   "
39589|NCT02538796|"~     Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality)~     that has changed little over in half a century. One of the forms is the restrictive anorexia~     nervosa (ANR). It consists of a phobia of weight gain and food with a massive food~     restriction. This pathology is studied in psychology but not using the theories of embodied~     cognition in which perception and action interact through sensorimotor processes. They are~     the source of attitudes (unconscious) towards certain stimuli and influence our~     interpretation (conscious).~   "
39590|NCT02538783|"~     This study aims to evaluate the effectiveness of financial incentives in improving and~     maintaining weight loss.~   "
39592|NCT02538757|"~     The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the~     herpes zoster (shingles) vaccine, Zostavax, in arthritis patients over 50 years old who are~     using anti-TNF therapy and who have not previously received the vaccine.~   "
39593|NCT02538744|"~     The investigators will assess the impact of treatment with doxazosin and modafinil, alone~     and in combination, on the subjective and reinforcing effects of cocaine in~     non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid~     design in which participants will be randomized into two groups: placebo and doxazosin 8~     mg/d. They will remain in their assigned group for the duration of the study. After~     titrating doxazosin to the target dose, study procedures will be completed three times, once~     during treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order~     such that 200 mg precedes 300 mg).~   "
39773|NCT02536378|"~     The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid~     Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of~     varying experience with the transcarotid technique.~   "
39594|NCT02538731|"~     Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction,~     also termed small endoscopic sphincterotomy plus endoscopic papillary large balloon~     dilatation, is safe and effective technique for the treatment of large CBD stones. However,~     in approximately 5-10% of patients, the removal of large bile duct stones may be difficult.~     For this selected group of patients for whom all conventional endoscopic stone treatment~     devices have failed, laser lithotripsy technology has provided an approach to the~     fragmentation of difficult bile duct stones.~      A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston~     Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy~     limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided~     laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted~     stone extraction therapy.~   "
39595|NCT02538718|"~     Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although~     it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine~     has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When~     such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute,~     but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want~     to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not~     inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between~     24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes~     period with their cervical ripening is more than 25%, the investigators randomise them in~     Ritodrine group or MgSO4 group. Then, the investigators will check the change of their~     interval of uterine contraction, degree of pain and the appearance of any side effects or~     treatment failure sign.~   "
39596|NCT02538705|"~     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in~     the treatment of ulcers related to diabetic foot syndrome~   "
39597|NCT02538692|"~     The purpose of this study is to test the efficacy and safety of a traditional Chinese~     medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome~     (IBS-D).~   "
39598|NCT02538679|"~     Postoperative pain can pose significant challenges in the postoperative recovery of patients~     undergoing major colorectal surgery. Traditionally, opioids have played an important role in~     treating postoperative pain. It is well established that opioids are highly effective in~     relieving pain; however opioids are associated with numerous side effects that include~     nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression,~     pruritus, drowsiness, sedation, and allergic reaction. These opioid side effects, which~     range in severity, can significantly interfere with discharge home following colorectal~     surgery. Significant interest exists in the use of local anesthetic based regional~     anesthesia techniques as a means to extend the analgesic window for patients undergoing~     colorectal surgery. Specifically, the use of the TAP block as an adjunct in postoperative~     pain control has been widely reported in the anesthesia and colorectal surgery literature.~     Historically, the block was performed in a blind fashion with relative success and presently~     the block is typically performed either with ultrasound guidance or laparoscopic~     visualization. While TAP block has shown to be effective in post-operative pain control, the~     techniques used to place the block have not formally been compared.~      The investigators are purposing a prospective, patient-blinded, randomized study of patients~     undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus~     laparoscopic visualization versus no TAP block. The investigators hypothesize that~     laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to~     perioperative pain control and either technique is superior to no TAP. In addition the~     investigators will measure procedural time, any adverse events related to the block, overall~     postoperative analgesic requirement, analgesic duration, postoperative pain scores, length~     of postoperative hospital stay, incidence of postoperative ileus, and overall patient~     satisfaction between the three groups.~   "
39599|NCT02538666|"~     The purpose of this study is to show that maintenance therapy with nivolumab, or nivolumab~     plus ipilimumab followed by nivolumab alone, will prolong Overall Survival and Progression~     Free Survival compared with placebo in subjects with extensive stage disease small cell lung~     cancer who have completed first line chemotherapy.~   "
39600|NCT02538653|"~     This study aimed at determining the 4-hours postprandial blood glucose and insulin responses~     to the ingestion of cereal product differing by their SDS content.~   "
39601|NCT02538640|"~     This is a laboratory-based research study conducted in two parts. Open cross-over design. 2~     test sessions per subject included in the study. It aims at determining the postprandial~     blood glucose and insulin responses to the ingestion of cereal product differing by their~     SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.~   "
39602|NCT02538627|"~     This is a Phase 1 open-label, dose-escalation trial using 3+3 design, evaluating MM-151~     co-administration with MM-121 at varying dose levels.~   "
39603|NCT02538614|"~     This study consists of 2 parts: Phase 1b and Phase 2. Phase 1 b will evaluate the safety and~     tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI~     836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and~     establish the maximum recommended Phase 2 combination dose (highRP2D) as well as an~     alternate lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the~     rates of complete response (CR) and of minimal residual disease (MRD) negativity with the~     combination at the highRP2D and the lowRP2D in participants with R/R CLL.~   "
39604|NCT02538601|"~     The purpose of this study was to test the efficacy of a CBT-based smoking cessation~     treatment enhanced with transdiagnostic skills for the management of anxiety and fear-based~     avoidance behaviors (CBT-A) relative to a standard CBT-based smoking cessation treatment~     (CBT-S) for smokers with elevated PTSD symptoms who were exposed to the 9/11 World Trade~     Center disaster. The investigators hypothesized that the CBT-A treatment would yield more~     favorable outcomes with regard to smoking abstinence as well as improvements in PTSD and~     respiratory symptoms over a 6-month follow-up period.~   "
39605|NCT02538588|"~     Comparison between two modalities of nebulization.~   "
39606|NCT02538575|"~     The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a~     prognostic factor for cystic fibrosis patients.~   "
39607|NCT02538562|"~     This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric~     and gastroesophageal junction cancer as assessed by local laboratories in a real-life~     setting. No investigational products will be provided or evaluated.~   "
39644|NCT02538068|"~     This study plans to learn more about psychosocial factors that contribute to adopting~     physical activity. The goal of this study is to improve upon existing theories of behavior~     change in order to help other people become more physically active.~   "
39811|NCT02535884|"~     The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and~     to show superiority of DBS on motor function in the stimulation group compared to~     stimulation-off group~   "
39608|NCT02538549|"~     Behavioral activation (BA) is a low cost, evidence-based intervention that can be effective~     in treating depression and anxiety. We have developed a behavioural activation card game for~     clients receiving treatment through the Crisis Team and Traditional Case Management (TCM) in~     Kingston, ON. The game is designed to integrate behavioural activation tools into daily life~     while receiving points for completion of the each Activity Challenge, which are divided into~     4 areas (ACE4), with the goal to receive maximum amount of points in the timeframe of the~     study. Using a Randomized Control Trial (RCT) design, participants (n=40) will be assigned~     to one of two groups, with the intervention group receiving ACE4 and treatment as usual~     (TAU) and the control group only receiving TAU. Assessments will be carried out upon entry~     to the study and at the end of the intervention period (8 weeks). Assessments will be~     completed using the WHODAS 2.0 (World Health Organization Disability Assessment Schedule),~     HADS (The Hospital Anxiety and Depression Scale), and CORE (Clinical Outcome in Routine~     Evaluation). We hypothesize that the treatment group receiving the ACE4 intervention will~     show improvement in overall mental state. Analyses will be conducted using SPSSv16, an~     analysis of covariance and t-test, and a binary logistic regression analysis will be used to~     investigate factors that predict good outcomes. Results will be published in international~     journals and presented at conferences with an aim towards being applied to clinics in~     Pakistan.~   "
39609|NCT02538536|"~     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050~     800 mg daily oral administration in 40 adult patients with IPF.~   "
39610|NCT02538510|"~     This phase I/II trial studies the side effects of pembrolizumab and vorinostat in treating~     patients with squamous cell head and neck cancer or salivary gland cancer that has come~     back, has spread to other places in the body and/or cannot be removed by surgery. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving pembrolizumab together with vorinostat may be a better treatment for~     head and neck cancer or salivary gland cancer.~   "
39611|NCT02538497|"~     The aim of this study is two-fold: 1) To study risk factors for the development of~     postpartum depression, including cognitive factors (i.e., perseverative negative thinking~     and interpretation of infant facial expressions), and other factors such as negative~     childhood experiences, parental attachment, parental stress and previous psychopathology. 2)~     Investigate the effect of The Newborn Behavioral Observation (NBO) as a universal prevention~     intervention implemented at well-baby clinics in Tromsø with regard to parental mental~     health, parent-infant interaction and child development.~   "
39612|NCT02538484|"~     Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese,~     postmenopausal breast cancer patients.~   "
39613|NCT02538471|"~     Patients with metastatic breast cancer receiving at least one single agent chemotherapy and~     demonstrating stable disease or disease progression at two consecutive clinical/radiological~     assessments (at an interval of at least 2 weeks).~      Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors~     and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study~     drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day~     cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given~     consecutively on days 1-3-5.~   "
39614|NCT02538458|"~     Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis~     in infants.~   "
39615|NCT02538445|"~     Based on the theory of embodied cognition, which focuses on the influence of sensory and~     motor processes on cognition, researchers propose to study the influence of the action on~     memorization and inhibition in patients suffering from schizophrenia, using a directed~     forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of~     action verbs. The instruction to forget is given at the end of learning the first list (To~     Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is~     presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is~     performed at the end. The action verbs had to be encoded using four conditions: action~     performed, mimed, imagined action, action with a contextual word, reading the action verb~     only. 48 schizophrenic patients were included in this study. Patients were randomized to~     have 10 participants per condition. 48 controls matched by age, gender, laterality and~     education are also included and randomized in the same modality. This study aims to show~     that the encoding of sensory-motor components, more than providing a context could improve~     the inhibitory capacities but also memory in schizophrenia, and possibly be used in~     remediation cognitive.~   "
39616|NCT02538432|"~     This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or~     non-small cell lung cancer.~   "
39617|NCT02538419|"~     The investigators will compare two alternatives designed to maximize adherence to continuous~     positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support~     administered in groups, versus individual education.~   "
39618|NCT02538406|"~     Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for~     screening purposes to find any precancerous lesions (polyps) at an early stage. During the~     colonoscopy the doctor will advance the colonoscope to the end of your colon and start~     examining the colon for any polyps. Withdrawal time is the period of time the doctor~     spends examining the colon. Doctors usually spend six minutes examining the colon after they~     reach the end of the colon. Studies have showed that spending more withdrawal time detects~     more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in~     examining the right side will increase the detection of polyps in the right side of the~     colon. There will be no other changes in the procedural aspect of the colonoscopy.~   "
39645|NCT02538055|"~     As many as 75% of people with diabetes report chronic pain. While cognitive behavioral~     therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and~     underserved communities lack resources for such programs. The investigators tested the~     hypothesis that a CBT-based program delivered by community health workers (CHW) can improve~     quality of life in individuals with diabetes and chronic pain.~   "
39752|NCT02536651|"~     There are no validated patient-reported outcome measures to assess lower extremity function~     in Finnish language. The present study aimed to 1)translate and culturally validate the~     Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity~     Functional Scale, and 2) study the psychometric properties of these two questionnaires~   "
39619|NCT02538393|"~     The primary objective of the study is to~      • Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for~     oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet~     formulation.~      The secondary objectives of this study are to~        -  Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet~          for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg~          (4 x 100 mg) dose of sorafenib in fasted state~        -  Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension~          formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)~        -  Evaluate the taste and palatability of sorafenib (both formulations)~        -  Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy~          male subjects~   "
39620|NCT02538380|"~     The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for~     left adrenal gland analysis in lung cancer patients.~   "
39621|NCT02538367|"~     A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose,~     parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation~   "
39622|NCT02538354|"~     This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease~     patients will result in an increase in the amount of F. prausnitzii.~   "
39623|NCT02538341|"~     The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the~     herpes zoster (shingles) vaccine, Zostavax, in patients over 50 years old with arthritis and~     other diseases who are using anti-TNF therapy and who have not previously received the~     vaccine.~   "
39624|NCT02538328|"~     Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery~     especially in gastric bypass surgery patients.~   "
39625|NCT02538315|"~     While positron emission tomography/computed tomography (PET/CT) can assist in the diagnosis~     of Parkinson disease (PD), it can also potentially help monitor treatment options for PD.~     One such experimental therapeutic option for PD is fetal dopaminergic transplantation~     trials. A potential goal of such novel therapies is to replace deficient dopaminergic~     neurons in PD. Researchers at the University of Saskatchewan have been at the frontier of~     these exciting treatment options. [18F]FDOPA PET/CT imaging has been successfully used by~     some authors to monitor engraftment and assess efficacy of fetal dopaminergic transplant .~     This study also aims to utilize [18F]FDOPA PET/CT imaging to potentially aid in detecting~     alterations in the dopaminergic pathway from these innovative surgical treatment options.~      There are two main objectives of this study: 1) Evaluate the effectiveness of fetal~     dopaminergic grafts in patients with PD using FDOPA PET imaging pre and post-surgical~     implantation and a secondary longer term goal 2) Correlate the [18F]FDOPA PET/CT findings in~     early PD with post-mortem pathological analyses of PD~   "
39626|NCT02538302|"~     Nocturnal enuresis is among the most common disorders in children. The aim of current study~     was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal~     enuresis in children in Bandar Abbas in 2014.~   "
39627|NCT02538289|"~     Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are~     becoming more frequent. Patients suffering from dyspnea have a significant disabling due to~     chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools~     that may produce an improvement of symptom intensity, they are underused.~   "
39628|NCT02538276|"~     Cerebrovascular disease is a leading cause of death and the leading cause of serious~     long-term disability. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are~     alternative strategies for stroke prevention in patients with atherosclerotic carotid~     disease.The safety and efficacy of CAS compared to CEA still remains questioned, and CEA has~     been considered to the first-line treatment of carotid stenosis in worldwide. The purpose of~     this study is to compare the practice and outcomes of CAS and CEA in a real world setting at~     Public University Hospitals in Brazil.~   "
39629|NCT02538263|"~     Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted~     tidal volume (VT) by automated adjustment of pressure support, could guarantee the delivered~     VT over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support.~     Whether VT-NIV is more effective in improving gas exchange in patients with acute~     hypercapnic respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was~     to verify whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting~     hypercapnia, hence reducing the need for intubation and improving survival in patients with~     AHRF.~   "
39630|NCT02538250|"~     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study~     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show~     that it is acceptable for patients in the United Kingdom.~   "
39631|NCT02538237|"~     Aim: Use an ibuprofen mouthwash 2% irrigate subgingival in improving the progression of~     periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic~     periodontitis without any systemic disease who have had periodontal disease, and 2 molars~     that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the~     clinical examinations. Interventions: For patients who participated in this study, subjects~     who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They~     were divided into two groups as determined by randomization in this study, Experimental~     group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic~     Azad University, Tehran), Control group: placebo, Subgingival Irrigation of ibuprofen 2%~     mouthwash with an insulin syringe 0.5 ml were rinsed, Clinical measurements including~     probing depth (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index~     (BI) were recorded and the patients were recalled per once every 2 weeks for 3 months is~     repetitive, and at the end of 3 months, were evaluated changes in clinical periodontal~     parameters. ®~   "
39657|NCT02537899|"~     SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and~     will provide important information on the feasibility of conducting larger controlled~     trials.~   "
39753|NCT02536638|"~     The purpose of this research study is to compare the amount of protein excreted by the~     kidneys in a 24-hour period between patients who have a kidney infection and those who do~     not have a kidney infection.~   "
39632|NCT02538224|"~     Objectives: The aim of the present clinical study was to evaluate the efficacy of doxycyline~     3% plus ketoprofen 2.5% as an adjunct to scaling and root planing in the treatment of~     chronic periodontitis(early-modearte). Material and Methods: 20 systemically healthy,~     chronic periodontitis patients were included in the study.The Patients were selected on the~     basis of having chronic periodontitis with periodontal pocket depths of more than 4mm on at~     least two teeth in mandibular molar area; Periodontal parameters (plaque, bleeding on~     probing and pocket depth) were recorded at baseline and every 15 days for 3 months. Oral~     hygiene instructions were given that included brushing twice- daily, (Using the Bass~     brushing technique for at least 2 minutes ), Randomly divided two groups,Test group: was~     treated by scaling and root planing Followed by local delivery of doxycycline 3%+ ketoprofen~     2.5%, While the control group: was treated by scaling and root planing along with ketoprofen~     2.5%; and was administered to the both groups every 15 days for 3 months, repeated. Every 15~     days once periodontal parameters were assessed, and at the end of 3 months, evaluated the~     clinical parameters changes.~   "
39633|NCT02538211|"~     The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus~     vaccine immune responses in healthy adult volunteers.~   "
39634|NCT02538198|"~     This is a Phase 2 study to assess the good and bad effects of maintenance therapy on~     patients who have been treated for myeloma and no longer show signs of this type of cancer.~   "
39635|NCT02538185|"~     The study is planned as a single-center, randomized, double-blind placebo-controlled,~     comparative Phase I, first-in-man study to assess the safety and tolerability of the~     NanoJect™ device, and the immunogenicity of the rabies vaccine Vaccin rabique Pasteur®~     delivered with the NanoJect™ device by ID route.~   "
39636|NCT02538172|"~     An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in~     D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV~     assay. Investigators will include kidney and liver transplant recipients. Patients will be~     randomized during the first month post transplant.~      In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be~     monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be~     done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis~     will depend on the result of the assay:~        -  T-Track positive (patient at lower risk): discontinuation of the antiviral drug~        -  T-Track negative (patient at higher risk): continuation of the antiviral drug until the~          maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a~          standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin~          treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both~          T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of~          the interventional arm, but the result will not be known by the investigators.~      After discontinuation of prophylaxis, patients in both arms will be followed for the~     development of CMV replication at each visit using the local PCR assay and antiviral therapy~     will be administered in case of CMV infection according to local guidelines.~      The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV~     replication during the first 12 months post transplant AND the duration of antiviral~     prophylaxis.~   "
39637|NCT02538159|"~     Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare~     the rate of bacteremia associated between non-tunneled Central venous catheter and~     peripheral inserted central catheter.~   "
39638|NCT02538146|"~     An open label pilot study will determine the effect of the amino acid nutritional supplement~     acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory~     mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is~     given to all participants for 3 months, and assessments will occur at intake and after 3~     months.~   "
39639|NCT02538133|"~     Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is~     often difficult (germs are found only in 50% of cases). Conventional imagery is often~     non-specific and difficult to interpret especially in early postoperative phase. Leukocytes~     isolated from the patient's blood are labeled with a radiopharmaceutical technetium~     99mTc-HMPAO.~      The aim of this study is to assess the overall diagnostic performance of scintigraphy~     (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis~     infection.~   "
39640|NCT02538120|"~     This study aims to see whether or not the diabetes 1 patients have a neurovascular~     microcirculatory dysfunction using various microvascular tests which have been previously~     validated.~      Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in~     Laser Speckle Perfusion Units (LSPU).~   "
39641|NCT02538107|"~     This observational study will investigate efficacy and safety of methoxy~     polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each~     participant will be collected over 15 months of Mircera therapy.~   "
39642|NCT02538094|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities in individuals with multiple sclerosis or~     encephalitis. Participants will be asked to come in for two full weeks of testing and may be~     asked to have one or more Magnetic Resonance Imaging (MRI) brain scans. In this research, a~     9 volt battery is used to deliver very weak electrical current to the surface of the scalp~     while participants complete cognitive tasks. The investigators' aim is to find out whether~     tDCS will improve task performance in adults with multiple sclerosis or encephalitis.~   "
39643|NCT02538081|"~     This study proposes to conduct a clinical trial comparison of olanzapine and the combination~     of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a~     dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test~     the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that~     enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This~     trial would enroll patients taking olanzapine and record baseline measurements of clinical~     symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects~     would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6~     weeks and then would again have measurements of clinical symptoms, cognition, metabolic~     parameters and extrapyramidal side effects.~   "
39812|NCT02535871|"~     The primary objective of this study is to compare the efficacy, safety and tolerability of~     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.~   "
39646|NCT02538042|"~     The central objective of the project is to evaluate the effect of incorporating smoking~     related contexts into very low nicotine content (VLNC) cigarette extinction trials on~     clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking~     (N=80) will be interviewed and trained to take pictures where they smoke cigarettes.~     Following taking these pictures, participants will then be switched to smoke VLNCs while~     wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period,~     half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of~     multiple context extinction (MCE+) during which they will view smoking-related environments~     and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE~     (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of~     the three weeks, participants will quit smoking and continue to wear the nicotine patch~     while being followed during a 10-week abstinence period. Participants will also complete a~     follow-up phone call 6 months after their quit day.~   "
39647|NCT02538029|"~     The primary aim of the proposed project is to characterize dual tasking (DT) deficits to~     improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's~     disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15~     individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation~     Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion~     capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural~     control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of~     these findings. This phase will involve creating a clinical intervention based on the~     objective information gathered the CAREN system. The intervention will take place 3x/week~     for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and~     2) Single task group (N=10). Outcome measures will be used at the beginning and end of the~     intervention to assess the feasibility and efficacy of the intervention.~   "
39648|NCT02538016|"~     The goal of this research project is to establish that in short-term use, tolvaptan is a~     safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot~     study of the safety and tolerability of this drug, and assess impact on urinary stone risk~     parameters, among adolescent and young adult patients with clinical cystinuria.~   "
39649|NCT02538003|"~     The purpose of this study is to assess safety, tolerability of LCB01-0371 after~     fasting/non-fasting food taken in healthy male subjects.~   "
39650|NCT02537990|"~     The purposes of this study are: 1. To identify and quantify the health utilities and quality~     of life experienced by patients who have been diagnosed with MDS and what are their~     predictors. 2. Measure the effects of patient related factors like frailty and comorbidity~     on quality of life and overall survival or toxicity to therapy. 3. Assess how quality of~     life changes over time and what are its predictors. This will be valuable information that~     may guide therapy, transfusion practices, etc., as MDS is a chronic, incurable disease that~     is often progressive.~   "
39651|NCT02537977|"~     Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy~     with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In~     this clinical trial, the investigators aim to assess the safety and efficacy of~     administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or~     refractory CD19 positive B cell malignancy including leukemia and lymphoma.~   "
39652|NCT02537964|"~     This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2%~     chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water~     according to gestational age and weight (e.g. standard bathing). The trial will take place~     in the Neonatal intensive care unit (NICU).~      Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug~     resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In~     the preliminary phase of the study we will establish the safety of chlorhexidine bathing~     using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted~     to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation.~     Interim analysis for adverse events will be performed after each group of patients.~      In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the~     study will be bathed three times a week with Chlorhexidine wash cloths during the initial~     6-months study period (intervention), followed by standard bathing during the second~     6-months period, then again intervention period for 6 months and standard bathing for~     6-months. Total study period- 3 years.~      Data collection will include all bloodstream infections as well as surveillance cultures~   "
39653|NCT02537951|"~     Small fiber neuropathy (SFN) is a common disorder, which has a profound negative impact on~     quality of life because of severe neuropathic pain. To reliably establish a diagnosis of SFN~     is challenging, since neurological examination and nerve conduction studies are often~     normal. Autofluorescent flavoprotein imaging (AFI) is an optical method through which~     neuronal activity in the termination area of small nerve fibers in the spinal cord can be~     quantified. Since the epidermis also contains a high density of small nerve terminals and~     since the number of intraepidermal nerve fibers is greatly reduced in patients with SFN, our~     hypothesis is that AFI intensity is reduced in patients with SFN. To support this~     hypothesis, a pilot study is required in which the investigators first need to confirm the~     precision of AFI in the epidermis of the third finger of 10 healthy volunteers. Secondly,~     lidocaine/prilocaine cream will be used as a negative control. Finally, the AFI signal will~     be measured after application of a 8% capsaicin patch, through which (temporarily) a~     selective reduction of small nerve fibers can be induced, mimicking SFN. Using this~     experimental design, the investigators will be able to test the reliability and validity of~     AFI for capsaicin-induced small nerve fiber degeneration. This would be a significant step~     in developing an objective, rapid and non-invasive diagnostic tool to diagnose patients with~     SFN, which may also be utilized as a biomarker in studies that assess the efficacy of novel~     treatments for SFN.~   "
39654|NCT02537938|"~     This study involves the use of an investigational drug called NGP 555. In each group of~     healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.~   "
39655|NCT02537925|"~     The purpose of this study is to determine whether celecoxib is effective in the treatment of~     nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.~   "
39656|NCT02537912|"~     The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose~     was demonstrated in a double-blind, placebo-controlled study. .~   "
39658|NCT02537886|"~     The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be~     developed as a patient-centered web-based mobile application and will be able to run on~     mobile devices. The development of VIC is to create a reusable infrastructure for~     integrating the informed consent process into clinical care and the clinical workflow in a~     way that enhances patient comprehension while improving the efficiency of obtaining patient~     consent.~   "
39659|NCT02537873|"~     The overall goal of this project is to develop initial human data on effects of novel~     compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine~     and self administration data) in non-treatment seeking cocaine use disorder subjects. The~     compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR~     agonists have been shown to reduce cocaine self-administration and cue reactivity in~     rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin~     as it is currently FDA approved for obesity, and safety data from a cocaine interaction~     study in rodents , but there is no human cocaine interaction/PK data and no PD data to~     support potential dosages for phase II clinical trials.~   "
39660|NCT02537860|"~     This prospective double-blinded clinical trial is intended to compare three nerve~     stimulator- guided paravertebral block injections versus five injections for elderly~     patients undergoing hernia repair regarding intraoperative hemodynamic stability and~     postoperative pain.~   "
39661|NCT02537847|"~     The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial~     agents which can be used in outpatient for the treatment of non-bacteremic acute~     pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was~     conducted to compare the clinical and bacteriological outcomes of patients with~     non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia~     coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV~     ertapenem.~   "
39662|NCT02537834|"~     An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and~     efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.~   "
39663|NCT02537821|"~     Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in~     severly burned patients. Potential HLA triggers in the treatment of severely burned patients~     are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory~     markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin)~     and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in~     severely burned patients.~   "
39664|NCT02537808|"~     The objective of this non-interventional study is to explore the safety, effectiveness and~     quality of life of lenalidomide / dexamethasone as first line treatment for~     transplant-ineligible patients with multiple myeloma in a real life setting.~   "
39665|NCT02537795|"~     In this study the investigators will use semi-structured interviews to qualitatively analyse~     patient and family member experiences with either deep brain stimulation or other forms of~     psychiatric neurosurgery.~   "
39666|NCT02537782|"~     Several attempts have been made to refine selection criteria for cardiac resynchronisation~     therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously~     proposed parameters probably do not sufficiently reflect the underlying mechanical~     dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that~     better candidate selection can rely on the direct observation or measurement of this LV~     mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and~     other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate~     regional myocardial workload and metabolism, and determine their predictive value in CRT~     response.~   "
39667|NCT02537769|"~     The use of implantable left ventricular assist devices (LVAD) has increased over the last~     decade; partly because the newer continuous flow pumps feature a smaller design and better~     durability. These pumps have shown improved outcomes for those patients who don't qualify~     for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to~     heart transplantation. Despite these improved outcomes, procedure related length of~     hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery~     treatments. One important reason for this is that many people experience right ventricular~     dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD~     patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR).~     This is the failure of the tricuspid valve (TV) to close completely so that blood leaks~     backwards. Some recent studies suggest that correction of the TV during LVAD implantation~     has improved survival for those with severe regurgitation. However, this has not been~     evaluated for mild or moderate regurgitation.~      The goal of this study is to look at the clinical impact of surgical correction of mild to~     moderate TR in participants who are also undergoing LVAD implantation. The study will look~     at the degree of TR at various time points post-surgery, as well as any major cardiac~     adverse events, duration of hospitalization, and quality of life. The investigators hope to~     show that surgical correction of mild to moderate TR in LVAD patients will reduce right~     ventricular dysfunction and have a positive impact on health outcomes.~   "
39668|NCT02537756|"~     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true~     among traditionally underserved adolescents. Few parent-targeted interventions have focused~     on the parental decision-making process. Self-persuasion, generating one's own arguments for~     engaging in a behavior, may be an effective means to influence parents' motivation to~     vaccinate their children. In a three-phase study, investigators are using quantitative and~     qualitative research methods to develop and refine a tablet-based self-persuasion~     intervention for parents who are undecided about the HPV vaccine. This clinical trial~     submission focuses on the second phase of the study. The results of the second phase will~     inform the third phase of the trial (also registered in clinical trials).~   "
39669|NCT02537743|"~     Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE~     Renal Cell Carcinoma population~   "
39670|NCT02537730|"~     Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each~     combination (lens / disinfecting cleaning system).~   "
39701|NCT02537314|"~     The overall hypothesis of this proposal is that nutrient sensing in the foregut regulates~     metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these~     mechanisms might be defective in obesity.~   "
39671|NCT02537704|"~     Obesity is the main modifiable risk factor for the development of chronic diseases in~     Mexico. Several randomized controlled trials have shown that intensive lifestyle programs~     are efficacious for the management of obesity. These programs include frequent sessions (14~     or more contacts in the first 6 months) focused on diet and physical activity and use a~     behavior change protocol. In Mexico most primary care clinics and public hospitals apply~     traditional treatments for obesity management, which have limited effect on weight loss.~     This study would provide scientific evidence for an effective model for obesity management.~     Objective. The purpose of this study is to evaluate the effectiveness of the Group~     Lifestyle Balance Program for overweight and obesity management in adults, in primary care~     clinics and public hospitals from Sonora. This is a translational clinical study. Healthcare~     providers from the participating clinics will be trained with the Group Lifestyle Balance~     Program before its implementation. The primary outcome measurement is the change in body~     weight from baseline to 6 months and 12 months. Changes in body mass index, waist~     circumference, systolic and diastolic blood pressure, depression, quality of life and stress~     scales will be measured in patients receiving the program before and 6 and 12 months after~     starting the program. Additionally, biochemical parameters (fasting glucose, total~     cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting insulin, Homeostatic~     Model Assessment- Insulin Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase~     (AST), Alanine Aminotransferase (ALT)] will be evaluated from baseline to 12 months.~   "
39672|NCT02537691|"~     Prospective, single-arm, longitudinal, international, multicenter study in a real-world~     cohort of adult severe asthma participants being conducted to assess the relationships~     between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.~   "
39673|NCT02537678|"~     Children who are exposed to traumatic events are at risk for developing PTSD and other~     mental health problems. Although effective treatments for childhood PTSD exist, service~     delivery approaches that are more accessible, efficient, and cost-effective are needed to~     improve access to evidence-based treatment. The proposed study furthers our pilot work and~     evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to~     optimize treatment in community settings and improve the value and efficiency of~     trauma-focused treatment for children compared to existing approaches, thereby reducing~     childhood PTSD and related societal impacts and costs.~   "
39674|NCT02537665|"~     To explore the effect of heating precondition of epidural catheter on the incidence of~     injury to blood vessel during epidural catheter placement.~   "
39675|NCT02537652|"~     Individuals who experience a stroke or transient ischaemic attack (TIA) are at heightened~     risk of subsequent vascular events, including heart attacks and secondary stroke/TIA. Blood~     pressure control is considered the most important contributor to positive health outcomes in~     stroke patients. The measurement of central blood pressure (cSBP) (the blood pressure which~     is being exerted at the heart), may provide clinicians with important diagnostic and~     prognostic information over and above that typically obtained from a peripheral blood~     pressure measure (the blood pressure in the arm). Central blood pressures may be better than~     traditional peripheral blood pressure measures as: i) peripheral blood pressure may not~     accurately reflect the effects of peak arterial blood pressure on centrally located organs,~     ii) central blood pressures may be 50 % superior to peripheral blood pressures when~     predicting cardiovascular events, and iii) information pertaining to central blood pressures~     may be more effective in the management of hypertension. While the validity of oscillometric~     devices which measure central blood pressures has been demonstrated, further study is~     required to determine precision under normal clinical operating conditions (i.e., reflective~     of the Hospital/GP practice setting). As such, this study will assess central and peripheral~     blood pressures of stroke patients when fasted and nonfasted, and when seated and supine.~     The study is interested in identifying the effect of the above parameters (fasted vs.~     unfasted, seated vs. supine) on central and peripheral blood pressures in stroke patients.~      Participants will take part in three separate assessment sessions, on three separate days,~     with a minimum 24 hour recovery between each session. Each assessment is expected to last 90~     minutes, with a minimum of eight blood pressures being taken from the left upper arm. As~     such, participants will be asked to give up 4.5 hours of their time to the study. During~     each assessment participants will be tested in a fasted and non-fasted state, and in a~     supine (lying) and seated position. All assessments will take place between 7 and 10am and~     will be undertaken following written informed consent.~   "
39676|NCT02537639|"~     The investigators would like to evaluate how well intensive care trainees without previous~     experience in transesophageal echocardiography are able to perform a transesophageal~     echocardiography study in the clinical setting after completing a simulator based training~     compared to conventional training.~   "
39677|NCT02537626|"~     This study evaluates the effect of applying low level laser light therapy to individuals~     with mild to moderate Alzheimer's disease to see if it may improve their memory, thinking~     and behaviors. Half of the participants will receive the real treatment with the laser~     device and the other half of the participants will receive a placebo treatment (not active~     laser).~   "
39678|NCT02537613|"~     This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as~     a possible treatment for Chronic Lymphocytic Leukemia (CLL).~   "
39679|NCT02537600|"~     The purpose of this study is to determine wether cobimetinib + vemurafenib combination~     treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain~     metastasis~   "
39680|NCT02537587|"~     The purpose of this study was to determine the effect of changing the amounts of resistant~     starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy~     bars. The investigators also compared the glucose and insulin responses to the rates at~     which the food bars were digested in-vitro (in the test tube). The investigators thought~     increasing resistant starch and reducing sugar would reduce the glucose and insulin~     responses, and that adding protein would reduce glucose and increase insulin. The~     investigators also thought the glucose and insulin responses in people would be related to~     the rate of digestion of the food bars in-vitro.~   "
39681|NCT02537574|"~     This study will evaluate the safety, effectiveness and tolerance of low doses of oral~     naltrexone along with buprenorphine to treat opioid use disorder prior to the first~     injection of VIVITROL.~   "
39682|NCT02537561|"~     In this proposed study the investigators will combine gemcitabine and cisplatin with~     talazoparib to determine the recommended Phase 2 dose (RP2D) of this combination regimen.~     After determination of the RP2D patients with lung cancer whose tumors carry molecular~     alterations in DNA repair pathway genes will be enrolled to an expansion cohort to determine~     anti-tumor efficacy. Tissue samples of patients with confirmed partial response, complete~     response, and non-responders will be obtained for whole exome, and transcriptome sequencing~     to characterize the genetic alterations associated with response to therapy.~   "
40607|NCT02525471|"~     The purpose of this study is to determine the safety and tolerability of RNS60 in patients~     with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of~     RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron~     emission tomography (PET) imaging.~   "
39683|NCT02537548|"~     This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in~     treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in~     the body behind the intestines that is typically the first place that seminoma spreads.~     RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and~     may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease,~     metabolic syndrome (pre-diabetes), or lung disease.~   "
39684|NCT02537535|"~     Cross-sectional observational study designed to identify and describe the care gap in~     guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian~     patients at high cardiovascular risk.~   "
39685|NCT02537522|"~     The objective of this study is to determine if corneal diameter and keratometry readings~     correlate to subjective comfort and lens fitting characteristics.~   "
39686|NCT02537509|"~     Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D~     supplementation or not, could be beneficial to improve disease LTC in AD patients~   "
39687|NCT02537496|"~     In this study the investigators aim at assessing and then enhancing neuroplasticity in the~     dorsolateral prefrontal cortex (DLPFC) and working memory - a key function of DLPFC - in~     patients with mild Alzheimer's disease (AD). The investigators will use Paired Associative~     Stimulation (PAS) paradigm to measure neuroplasticity and then a 4-week course of~     high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) to the DLPFC to enhance~     cognitive function. Clinical and cognitive assessments will be done at baseline, one week,~     one month and 6 months after the rTMS course. Healthy controls will also be enrolled to~     carry out baseline cognitive assessments and a baseline measurement of neuroplasticity.~   "
39688|NCT02537483|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects~     with moderate to severe acne vulgaris.~   "
39689|NCT02537470|"~     This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of~     doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered~     over 12 weeks in subjects with type 2 diabetes mellitus.~   "
39690|NCT02537457|"~     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet~     15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability~     of rivaroxaban 15 mg in healthy adult male subjects.~   "
39691|NCT02537444|"~     To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and~     acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian~     cancer~   "
39692|NCT02537431|"~     UX023-CL304 is a Phase 3 open-label, single-arm, multicenter study to establish the effects~     of KRN23 on bone quality and osteomalacia associated with XLH. Approximately 14 adult~     subjects with a diagnosis of XLH supported by typical clinical and biochemical features and~     who have not received oral phosphate and vitamin D therapy in the past two years will be~     enrolled. Iliac crest bone biopsies will be performed at baseline and end of study. Baseline~     histologic and histomorphometric assessments of the bone biopsy specimens will be performed~     as each biopsy is completed to assess sample quality and confirm the presence of~     osteomalacia in at least 8 subjects.~   "
39693|NCT02537418|"~     The purpose of this study is to find the highest dose of durvalumab or of durvalumab with~     tremelimumab that can be tolerated without causing very severe side effects when receiving~     standard chemotherapy and to see what effects the study drugs has on this type of cancer.~     Patients may receive durvalumab alone or in combination with tremelimumab.~   "
39694|NCT02537405|"~     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet~     10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of~     rivaroxaban 10mg in healthy adult male subjects.~   "
39695|NCT02537392|"~     The purpose of this study is to determine whether daily oral supplements of vitamin B~     complex along with folic acid or supplements of iron plus folic acid given to women during~     peri-conception can reduce the risk of congenital heart disease when compared with folic~     acid alone.~   "
39696|NCT02537379|"~     This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF)~     administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety~     and efficacy of SOF administered in combination with ribavirin under real world use in~     Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and~     treated with SOF+ribavirin in routine clinical use, the primary objective of this study is~     to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.~   "
39697|NCT02537366|"~     Crossover randomized controlled double blinded trial :~        -  The primary endpoint is the duration of Non Invasive Ventilation (NIV) session~          (minutes) with dexmedetomidine (DEX) or placebo.~        -  Secondary endpoints will be the sedation level as assessed by the Richmond Agitation~          Sedation Scale (RASS), the number of interventions to allow the completion of NIV~          session, the pain intensity level as assessed by visual analogue scale, the morphine~          and ketamine consumption during NIV sessions, the comparison of blood gas measurements~          before and after NIV sessions, the reproducibility of NIV cycles. The side effects of~          DEX will be notified.~   "
39698|NCT02537353|"~     The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding~     located proximal to the angle of Treitz, whose cause is not related to esophagogastric~     varices or gastropathy of portal hypertension.~      Animal studies showed no absorption in the GIT and disposal within 48 hours of application,~     and no reported cases of obstruction. Recently, a prospective study involving 20 patients~     with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted~     hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without~     any complication.~   "
39699|NCT02537340|"~     The hypothesis to be proven with this study is that the use of PET/CT on the initial staging~     of rectal cancers in patients with extramural vascular invasion detected by MR will detect~     more lesions than conventional work-up and will significantly impact on therapeutic~     decision, improving disease free and overall survival.~   "
39700|NCT02537327|"~     The aim of this study is to determine the incidence of recurrent caries around the different~     types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better~     characterize recurrent caries lesions in terms of location and size of the lesions and type,~     material and age of the restoration.~   "
39702|NCT02537301|"~     Group chat through the platform of mobile social networking provides an easily accessible,~     real-time and interactive channel for communication. With the help of mobile social app, a~     group of doctors with similar interests can share valuable cases, important papers and~     opinions through multiple media types (texts, images, and videos). It remains unknown what~     activities of Endoscopic Retrograde Cholangiopancreatography(ERCP) doctors on a group-chat~     platform are.~      In the beginning of 2013, a chatting group on Wechat (the most popular mobile social app in~     China), focusing on ERCP, was created. All the doctors who received and finished their ERCP~     training in Xijing Hospital of Digestive Diseases were invited to join in the platform. The~     contents in the chatting group were analyzed. The relationships between the chatting~     activities of ERCP doctors and the performance of ERCP (such as case volume, cannulation~     success rate and PEP etc.) were investigated.~   "
39703|NCT02537288|"~     The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon~     dose administration relative to placebo in healthy adult male and female subjects.~   "
39704|NCT02537275|"~     Investigators planned to investigate changes in visual function after wearing decorative~     tinted soft contact lenses with different pigment-free optical zone diameters.~   "
39705|NCT02537262|"~     Preoperative midnight NPO is a traditional method for preventing aspiration during general~     anesthesia. However, recent studies reported that drinking carbohydrate beverage, three~     hours prior the surgery helps reducing patients starving, uncomfortment, and fatigue without~     other complication. QOR 40 is developed for evaluating patients' recovery condition~     regarding physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS)~     is a concept for reducing patients' hospital stay and helping recovery. Studies showed that~     drinking carbohydrate beverage made better recovery of bowel function and shorter hospital~     stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic~     surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate~     drinking through this study.~   "
39706|NCT02537249|"~     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics,~     anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial~     of intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from~     surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be~     enrolled. Patients will be recruited before the date of their surgery and will complete the~     Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours~     post op. They will also complete clinically significant pains score and oxygenation from the~     postanesthetic recovery unit (PACU).~   "
39707|NCT02537236|"~     The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active~     Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition~     and dyslipidemia, wich increase the cardiovascular risk.~      The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty~     acids to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National~     Cholesterol Education Program on the profile of lipids and the corporal weight in patients~     with HIV treated with HAART.~   "
39708|NCT02537223|"~     This is a phase 1 study (the first step in testing a new drug or combination, to see how~     safe the drug and/or combination are) of investigational agent BYL719 in patients with~     locally advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and~     chemotherapy (cisplatin).~      BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha.~     PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of~     chemical reactions among proteins in the cells that are involved in the support of normal~     cellular function. If the pathway is too active, due to changes in those proteins, the~     pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop~     cancers in laboratory and animal studies.~      This study is the first time BYL719 will be combined with radiation and chemotherapy.~   "
39709|NCT02537210|"~     The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely~     withdrawn in patients with long-standing clinical inactive UC.~   "
39710|NCT02537197|"~     This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers~     will also be scanned pre- and post-treatment where we will investigate the functional~     changes to tasks designed to engage brain region associated with gambling and addiction.~     These changes will be correlated with treatment outcomes and urge scores.~   "
39711|NCT02537184|"~     Objectives: To assess the beneficial and harmful effects of two recall intervals on caries~     incidence (primary outcome) in preschool children with high caries risk. The level of~     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)~     according to each interval will also be assessed. Methods: The sample will consist of 224~     children between 3-5 years of age, of both genders, with high caries risk according to the~     clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be~     randomly allocated into two study groups: Group 1 (G1) - oral clinical examination +~     orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral~     clinical examination + orientation for oral health and diet in return for 8 months. An~     examiner calibrated and blinded to the study groups and the secondary outcomes will perform~     the clinical examinations, which consist of: gingival bleeding index, dental plaque index,~     detection of caries and its activity according to the ICDAS (International Caries Detection~     and Assessment System) and the clinical features of active and inactive caries lesions will~     be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will~     conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL~     measured by B-ECOHIS, the time and costs. All groups will be followed for an initial period~     of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All~     analyzes will be performed by intention to treat (ITT) and considering the sensitivity~     analysis to assess the differences between the ITT analyzes and analyzes of complete cases.~   "
39712|NCT02537171|"~     The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic~     adenocarcinoma of stomach or gastroesophageal junction.~   "
39713|NCT02537158|"~     This study is a prospective non-randomized controlled study. The purpose of this study is to~     evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization~     (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after~     radical surgery.~   "
39718|NCT02537093|"~     Specific Aims: This study aims to assess the acceptability of asynchronous~      telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF)~      population, in a 12-month randomized controlled trial. ATP relies on video recording of a~      psychiatric interview, where the video is later reviewed by a psychiatrist to make a~      psychiatric diagnosis and treatment recommendation to the primary treatment team.~      STP is real-time, face-to-face psychiatric assessment using video conferencing to come~      up with a psychiatric recommendation. People residing in SNFs generally rely on primary~      and consultant physicians to visit them and rarely have outpatient psychiatrist follow-up.~      SNFs offer more services than what is available to primary care office, and include 24-~      hours skilled nursing services, physical therapy, nutritional consultation, occupational~      therapy, social services, wound care, and psychiatric consultation when available. SNF~      residents are unable to live independently due to their multiple medical comorbidities~      and are therefore more medically ill than patients who are typically seen in primary care~      settings. The present study aims to demonstrate feasibility and to collect pilot data in~      SNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant~      via the California Mental Health Services Act (Prop 63). In a larger, future study, the~     investigators~      intend to demonstrate that ATP will be no different than STP in clinical outcomes but will~      be more accessible and cost effective.~   "
39719|NCT02537080|"~     The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through~     the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral~     blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly~     inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of~     nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal~     cytokine networks are important in the development of nerve cell damage that leads to~     cognitive impairment.~   "
39720|NCT02537067|"~     The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus~     Chondrocyte) in patients with cartilage defects in their ankle for 18 months~   "
39721|NCT02537054|"~     The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the~     treatment of choroidal neovascularization and fibrovascular proliferation in patients with~     pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.~   "
39722|NCT02537041|"~     SITUATION ON RESEARCH Diastolic heart failure (HF) or heart failure with preserved systolic~     function (SF) is the primary cause of heart failure in the elderly (over 2/3 of heart~     failure in patients over 60 years). Its main cause is hypertension. The diagnosis of~     diastolic heart failure is still controversial in clinical practice. It is based on~     ultrasound and biological criteria (or MRI). Basically, it is concerned patients making~     acute pulmonary edema with preserved SF and high BNP. It is now recognized that the primum~     movens of this type of HF is increased myocardial stiffness secondary to LVH. Noninvasive~     assessment of this parameter would allow a more accurate and reliable diagnosis because not~     dependent on load conditions unlike the ejection fraction (EF) and trans-mitral Doppler.~     However, the absence of non-invasive tool for the direct evaluation of the diastolic~     stiffness (so-called passive) prevents to date to use this diagnostic parameter.~      The investigators propose here to evaluate noninvasively myocardial stiffness in elderly~     patients with diastolic heart failure using a new imaging tool that uses an innovative~     ultrasonic technology, the ultrafast echo associated with its elastography function~     ShearWave Imaging (SWI). The investigators work for several years in collaboration with~     the Langevin Institute on this technology which was recently validated in experimental~     models. Its principle is based on the creation of a shear wave from a standard ultrasound~     and calculating the velocity of this wave with the high time resolution of the ultrasound~     probe, this being correlated with the speed myocardial stiffness.~      The human study was recently made possible by the development of a phased array probe having~     the opportunity to work with elastography mode (SWI).~      PURPOSE OF RESEARCH The goal will be to demonstrate the interest of the non-invasive~     evaluation by ultrafast echo (SWI) of myocardial stiffness in the diagnosis of diastolic~     heart failure in the elderly.~   "
39723|NCT02537028|"~     The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is~     to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of~     MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).~   "
39724|NCT02537015|"~     This study evaluates the long-term (9-months) safety of the Bimatoprost Ocular Insert in~     subjects with Glaucoma or Ocular Hypertension. All the subjects will receive Bimatoprost~     Ocular Insert and will wear it for approximately 3 months (12 weeks), then will have a that~     Insert removed and a new Insert placed for another 24 weeks (approximately 6 months).~   "
39725|NCT02537002|"~     The purpose of this study is the following:~        -  To determine the safety and tolerability of single ascending intravenous (IV) doses of~          PF-05230907 in healthy Japanese subjects.~        -  To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy~          Japanese subjects.~        -  To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy~          Japanese subjects.~        -  To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects~   "
39726|NCT02536989|"~     The investigators will include those patients with adherent clot on gastric or duodenal~     ulcers after endoscopic confirmation After receiving well explanation and giving written~     consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first~     group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the~     second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The~     patients in both groups will receive intravenous omeprazole for 3 days and then oral~     esomeprazole qd for further treatment of peptic ulcer.~      The investigators define rebleeding during admission and within 30 days as primary end~     points and define surgical intervention for ulcer bleeding, transfusion amount and~     hospitalization days after allocation as secondary end points.~   "
39727|NCT02536976|"~     There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a~     lack of pharmacotherapies with an acceptable side effect profile. Specifically, available~     anticholinergic medications have a high risk of cognitive side-effects, which preclude their~     use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely~     to be adversely affected by the currently available anticholinergic agents. Mirabegron is~     the first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic~     hypotension (OH), somnolence, and dry mouth in PD.~   "
39754|NCT02536625|"~     NK (Natural Killer) cells are important in the fight against tumor, especially for the~     control of cancer metastasis. The purpose of this prospective study is to evaluate the~     impact on lymphocytes NK functions and development of an everolimus treatment in women~     treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions~     and development under everolimus treatment could permit to validate an early biomarker of~     the impact of everolimus on these NK cells.~   "
39728|NCT02536963|"~     Amblyopia (lazy eye) and strabismus (misaligned eyes) are medical eye conditions that~     combine as the leading causes of preventable vision loss in children. They are irreversible~     if not detected and corrected by the age of seven, however half of all cases are missed~     because the conditions do not always manifest themselves and pediatricians are unable to~     reliably detect the conditions. The current health care system badly needs an accurate and~     effective approach toward detecting amblyopia and strabismus in preschool children.~      The study will be conducted in busy, ethnically and racially diverse primary care sites~     operated by the Kaiser Permanente system and compare the outcomes of testing with a~     Pediatric Vision Scanner with outcomes the current standard of care.~   "
39729|NCT02536950|"~     This is an open-label, non-randomized, pilot study to determine the safety and feasibility~     of the insulin-only bionic pancreas.~   "
39730|NCT02536937|"~     Primary Objective:~      To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics~     (PK) of eliglustat.~      Secondary Objective:~      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with~     mild, moderate, and severe renal impairment in comparison with matched subjects with normal~     renal function.~   "
39731|NCT02536924|"~     Crisis Teams are now a well established part of the mental health system. These teams are~     effective in providing crisis management, treatment, referral, and educational services. We~     are testing a waiting room intervention for the patients attending a Crisis Team. As far as~     we are aware, no trial of a waiting room intervention has been reported in a psychiatric~     setting. This is a preliminary study using a Randomized Control Trial (RCT) Design. Patients~     (N =40) will be randomly allocated to either the treatment or the control group, and will be~     selected from the local Crisis Team. The treatment group will receive a waiting room~     intervention called, RESOLVE (Relaxation, SOLving problem and cognitiVe Errors), that is a~     short film, Plus Treatment As Usual (TAU), and the control group will receive only TAU.~     Patients in both groups will be assessed before and after the intervention, using the HADS~     (Hospital Anxiety And Depression Scale), CORE (Clinical Outcome in Routine Evaluation), (to~     measure psychopathology) and WHODAS (World Health Organization Disability Assessment~     Schedule) (for functioning). We hypothesize that the treatment group will demonstrate~     significant improvement in mental health and functioning, compared to the control group.~     Analyses will be conducted using SPSS v22, and will consist of a t-test or Chi Square test~     to measure the baseline differences, and a linear regression to compare the differences~     between the two groups at the end of the intervention. Results will be published in~     international journals and will be presented in local and international conferences.~   "
39732|NCT02536911|"~     Primary Objective:~      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of~     eliglustat.~      Secondary Objective:~      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with~     mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic~     function.~   "
39733|NCT02536898|"~     The main aim is to assess the effectiveness of introducing a standardized intervention~     program for treatment of fracture patients as measured by changes in the fracture rates and~     the mortality.~   "
39734|NCT02536885|"~     Permanent and temporary cognitive impairment in the perioperative period is of great~     importance to patients. Hypoperfusion due to the intraoperative hypotension is often~     mentioned as a possible cause of postoperative cognitive dysfunction.~   "
39735|NCT02536872|"~     The concept of organisms living on or in the human body without causing overt signs of an~     infection is common in medicine and has been termed a microbiome. Urine from patients with~     Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is~     not known if the bacteria that have been identified are innocent commensals or pathogenic~     organism responsible for the symptoms of OAB. Previous data suggests that treatment with~     antibiotics does lead to an improvement in overactive bladder symptoms in a large number of~     patients. On this basis the investigators now treat are patients with similar antibiotic~     regimes. If antibiotics improve symptoms it would be expected that they would return the~     microbiome back to how it is in patients without OAB. This study aims to identify the~     effects of antibiotics on the urinary microbiome and to identify/confirm if antibiotic~     treatments cause improvement in OAB.~   "
39736|NCT02536859|"~     This trial is conducted in Europe. The aim of the trial is to compare pharmacodynamic (the~     effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial~     drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at~     steady-state conditions in subjects with type 1 diabetes mellitus.~   "
39737|NCT02536846|"~     The primary aim of this study is to investigate antipsychotic drug effects on healthy brain~     metabolism.~   "
39738|NCT02536833|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of three~     different strengths of SM04690 injected in the target knee joint of moderately to severely~     symptomatic osteoarthritis subjects.~   "
39749|NCT02536690|"~     Propofol in combination with remifentanil or midazolam can result in synergistic or additive~     effect.~      The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120~     patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will~     receive general anesthesia only with propofol and group PR and PMR will receive 0.25~     mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive~     0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success'~     is defined as loss of both verbal response and eyelash reflex in 2 min after propofol~     administration. When 'success', the next patient will receive the same dose(in 18/19~     probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the~     next patient will receive 0.25 mg/kg higher dose of propofol at induction period.~   "
39750|NCT02536677|"~     EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute~     chest pain from a regional representative sample in China.Findings will allow new~     opportunities to facilitate the clinical quality improvements and ultimately reduce the~     mortality and health care burden in patients with acute chest pain. It also will help to~     establish a regional network and database for further research and performance improvement.~   "
40857|NCT02522221|"~     TACT is a real world randomized controlled trial of tecarfarin, a novel vitamin K~     antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the~     two groups of subjects who require chronic oral anticoagulation for a broad panel of~     indications.~   "
39739|NCT02536820|"~     The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the~     interactions between the processes of adaptive behavior, neurological, endocrine and immune.~      Among its premises assuming homeostasis or physiological balance as an integrated process~     involving the systems above mentioned.~      Additionally, among the basics theme the re-mean is introduced, ie changing the direction,~     the function of a concept from a negative context carry a positive meaning, so that from the~     PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits~     the importance of which will come.~      Primary objective:~      To investigate whether patients on PNIT have a higher proportion of patients achieving~     disease control (<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with~     conventional treatment patients.~      Methodology:~      quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The~     investigators will follow a group of patients with type 2 diabetes mellitus durgin three~     months with an interim analysis a month after receiving the intervention (two visits) During~     each visit a trained PNIT physician assess the effectiveness, safety and quality of life of~     each patient.~      The investigators will include male or female patients aged 18 years-old with diabetes~     mellitus type II in any severity, uncontrolled (> 7% Glycosilated Haemoglobin (HbAc1)) and~     any treatment regimen included.~      The patients are not allocated by a random process and the investigators will have a~     convenience sample~      The investigators will perform an intention to treat analysis, patients will be analyzed~     according to the intervention received even if this was different from the one they were~     assigned.~   "
39740|NCT02536807|"~     Open gingival embrasures, also called black triangles, may occur after surgical~     intervention or tooth replacement by an implant. They are perceived as anaesthetic by most~     patients and causing functional and phonetic problems. The aim of the present study is to~     assess the effect of injection of hyaluronic acid for papilla augmentation next to an~     implant restoration in a clinical controlled double-blinded randomized trial with 6 months~     follow-up.~   "
39741|NCT02536794|"~     The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in~     combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both~     MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight~     infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may~     prevent cancer growth by helping certain blood cells of the immune system get rid of the~     tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by~     inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these~     drugs may result in better treatment options for patients with breast cancer.~   "
39742|NCT02536781|"~     The purpose of this study is to compare the oral inflammatory reduction effect caused from~     orthodontic treatment of anthocyanin and placebo mouthrinse.~   "
39743|NCT02536768|"~     The South Africa National Department of Health (NDOH) intends to launch its newly developed~     National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs) throughout South~     Africa in the coming year. Early implementation of the minimum package of interventions~     described in the Adherence Guidelines for HIV patients will take place at 12 primary health~     clinics and community health centres in four provinces starting in July 2015. To maximize~     the learning potential of this early implementation stage, NDOH will match the intervention~     clinics with 12 comparison clinics and randomly allocate intervention or comparison status~     within the pairs of clinics. This will allow the outcomes of the interventions to be~     evaluated using a cluster-randomized design and generate data on the costs of implementation~     and the potential need for adherence support for the other diseases addressed in the~     guidelines (tuberculosis, hypertension, and diabetes). This protocol is for the evaluation,~     which will generate information on the effectiveness of minimum package interventions and~     help improve the design, implementation, and budgeting of the guidelines.~      The study will assess the effectiveness of five interventions in the minimum package: 1)~     Fast track initiation counseling for patients eligible for antiretroviral therapy; 2)~     Enhanced adherence counseling for unstable patients on HIV treatment; 3) adherence clubs for~     stable patients on HIV treatment; 4) decentralized medication delivery for stable patients~     on HIV treatment; and 5) early tracing of all patients who miss an appointment by two weeks.~     This study will also estimate for each study site an overall adherence guideline impact to~     provide an indication of the effectiveness of the package as a whole.~      In addition, the study will estimate the cost of each of the interventions listed above~     compared to standard of care. Finally, the study will describe the cascade of care for~     tuberculosis, hypertension, and diabetes, three other chronic diseases for which little~     information currently exists. To evaluate these interventions the study team will work with~     the National Department of Health (which will implement the interventions) to randomize 24~     clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. All~     evaluations will use data routinely collected by the clinics, with no study interaction with~     subjects. A total of 6,680 patients will be enrolled and followed for up to 20 months to~     estimate short- and long-term outcomes.~   "
39744|NCT02536755|"~     Primary Objective:~      Evaluate long term skeletal response to eliglustat in adult patients who successfully~     completed the Phase 2 or Phase 3 studies.~      Secondary Objective:~      Evaluate the safety of eliglustat in adult patients who successfully completed the Phase 2~     or Phase 3 studies.~   "
39745|NCT02536742|"~     This international, multicenter, randomized, double-blind, placebo-controlled, Phase II~     clinical trial with the primary objective of demonstrating the superiority of palbociclib in~     combination with fulvestrant over placebo plus fulvestrant in prolonging progression free~     survival (PFS) in post-menopausal women with hormone receptor positive, HER2-negative~     metastatic or locally relapsed breast cancer whose disease has progressed after prior~     endocrine therapy (1st or 2nd line).~   "
39746|NCT02536729|"~     Objective: The primary objective of this study is to assess the quality of life of people~     treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging~     procedures, according to the outcome variables reported by patients.~      Type of study: A non-interventional observational analytic prospective cohort study.~      Sample: We will include people who need bowel cleansing for the realization of imaging tests~      Exposures: - oral sodium phosphate normal regimen~        -  Oral sodium phosphate with modified diet~        -  Polyethylene Glycol + electrolytes~      Follow-up time: 8 days after the bowel preparation~      Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium,~     Potassium, Calcium)~   "
39747|NCT02536716|"~     To compare platform-switched implants to platform-matched implants for replacement of a~     single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation~     to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle~     apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.~   "
39748|NCT02536703|"~     To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for~     Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic~     stenosis.~   "
39751|NCT02536664|"~     It is a non-interventional study with a duration of approximately 24 months per participant~     to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab~     maintenance therapy in daily routine in participants with previously untreated, relapsed or~     refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in~     clinical practice.~   "
39757|NCT02536586|"~     The main purpose of this study is to evaluate the tolerability of an investigational drug~     known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread~     to another part(s) of the body. The study will also explore the safety of the drug. It will~     measure how much of the drug gets into the blood steam and how long the body takes to get~     rid of it. It will investigate anti-cancer activity.~   "
39758|NCT02536573|"~     This is a prospective, randomized study of total hip arthroplasty with and without the use~     of Radlink surgical positioning software. The investigators are interested in discovering~     whether the use of the Radlink software will provide more accurate acetabular cup position~     when compared with surgeon estimates based on visual inspection of fluoroscopic images.~   "
39759|NCT02536560|"~     In this prospective observational cohort study the potential clinical consequences of~     antibiotic use in early life and perturbations in the gastrointestinal microbiota~     composition due to that antibiotic use are studied. It is hypothesized that altered~     microbiota may be an important underlying mechanism for impediments in the developing immune~     system.~      Differentiation will be made between a group of neonates who received antibiotics in the~     first week of life, and control infants who were not exposed to antibiotics in the neonatal~     period.~   "
39760|NCT02536547|"~     This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection~     Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS~     - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).~   "
39761|NCT02536534|"~     Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity~     tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with~     Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension~     (CTEPH) over 6 months in routine clinical practice settings.~   "
39762|NCT02536521|"~     This prospective observational study aimed to identify the intraoperative variables to~     predict the hemodynamic change according to intra-abdominal pressure in the children~     undergoing laparoscopic surgery.~      The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure~     variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform~     amplitude (△POP),and pleth variability index (PVI).~   "
39763|NCT02536508|"~     Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with~     Moderate to Very Severe Chronic Obstructive Pulmonary Disease~   "
39764|NCT02536495|"~     This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and~     to see how well they work when given together in treating patients with squamous cell lung~     cancer that has come back or spread to other places in the body. Selinexor may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving selinexor together with docetaxel may work better in treating squamous~     cell lung cancer.~   "
39765|NCT02536482|"~     It is a study to assess the tolerance to a new commercially available infant formula in~     children affected by Cow`s Milk Allergy.~   "
39766|NCT02536469|"~     A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic~     or unresectable, locally advanced malignant solid tumors.~   "
39767|NCT02536456|"~     China PEACE Millions Persons Project is a national screening project for cardiovascular~     disease in China. This Project was approved by National Health and Family Planning~     Commission (NHFPC), China and founded by Ministry of Finance, China in 2014.~      The specific objectives of the project are to:~        1. identify subjects at high-risk of CVD and provide counseling for medication and~          lifestyle improvements~        2. evaluate the feasibility of such screening methods for subjects at high risk of CVD,~          and to assess the effect of health counseling on CVD incidence rates and risk factors~          control~        3. inform future intervention and long-term follow up efforts for primary and secondary~          CVD prevention in China.~   "
39768|NCT02536443|"~     The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an~     observational study on an all-comer systolic heart failure population hospitalized in a~     highly specialized cardiovascular center. The aim of the study is to assess the clinical~     characteristics, treatment modalities and prognosis in this population.~   "
39769|NCT02536430|"~     The aim of this study was to determine whether combining an intraoral injection of a non~     steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior~     alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.~     Forty adult volunteers with including criteria has been randomly divided into two groups~     (n=20). All patients received standard inferior alveolar nerve block injection. After~     achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the~     other one received a buccal infiltration of Normal Saline as placebo. Any pain during root~     canal treatment has been recorded using analog visual scale. The success was considered as~     none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and~     chi-squared tests.~   "
39770|NCT02536417|"~     The purpose of this study is to determine if melatonin administration to end-of-life~     patients is effective in preventing the development of delirium compared with those who do~     not receive this treatment. Delirium is a difficult to control symptom commonly seen in~     patients at the end-of-life. A person who is delirious is unable to think clearly and cannot~     make sense of what is going on around him/her.~   "
39771|NCT02536404|"~     The purpose of this study is to determine whether APD334 is a safe and effective treatment~     for ulcerative colitis after 52 weeks of treatment.~   "
39772|NCT02536391|"~     This Phase I, open-label, randomized, 3-period crossover study was designed to determine the~     relative bioavailability of ipatasertib administered as capsule and tablet formulations to~     healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be~     determined. Participants will be randomized to one of six treatment sequences to receive~     three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in~     the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the~     fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations~     will be performed throughout the study. Time on study is expected to be 3 weeks.~   "
39774|NCT02536365|"~     A common feature of ASD is over or under sensitivity to the environment and difficulty~     putting sensory information together in an orderly way, referred to here as sensory issues.~     Building on previous work, this study will test the efficacy of Sensory Integration Therapy~     (SIT), a non-invasive intervention to improve functional skills in children with ASD, in~     comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms.~     A total of 180 children with ASD and sensory issues in the greater New York City~     Metropolitan area will complete this study.~   "
39775|NCT02536352|"~     The purpose of this study is to determine whether fluoride supplementation during pregnancy~     is effective in extending the length of gestation and improving overall perinatal~     well-being.~   "
39776|NCT02536339|"~     This study will examine the safety and efficacy of pertuzumab in combination with high-dose~     trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease~     progression in the brain following radiotherapy.~   "
39777|NCT02536326|"~     The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of~     resistant hypertension in Chinese patients in a prospective cohort study.~   "
39778|NCT02536313|"~     This study will evaluate the efficacy, safety, and tolerability of the treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin~     (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior~     treatment experience with a direct acting antiviral as measured by the proportion of~     participants with sustained viral response 12 weeks after cessation of treatment (SVR12).~   "
39779|NCT02536300|"~     This study will optimize the safety and efficacy of chronic administration of idelalisib in~     participants with follicular lymphoma (FL) and evaluate the overall safety profile of~     idelalisib and the overall response rate (ORR) by Week 24.~   "
39780|NCT02536287|"~     The purpose of this study is to compare short-term and long-term efficacy of total~     parathyroidectomy with autotransplantation and total parathyroidectomy without~     autotransplantation for Secondary hyperparathyroidism.~   "
39781|NCT02536274|"~     Aim of the study is to analyze systematically by using surface EMG the effect of the dynamic~     flexion orthosis Dynaflex® and the back bandage Lumbo Sensa® on the voluntary activation of~     the low back muscles and thereby on the muscles' stiffness.~      Patients have to pass a course with 6 different exercises in which they have to carry out~     certain activities of daily life under controlled conditions to examine, if the particular~     technical aid has a positive impact on pain-related activation of the back muscles.~   "
39782|NCT02536261|"~     The purpose of this study is to observe whether dopamine agonists can be safely withdrawn~     after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous~     sinus have been effectively controlled through pharmacological treatment.~   "
39783|NCT02536248|"~     Inflammatory processes are increasingly being recognized as a critical step in the~     pathogenesis of both diabetes and heart disease and may constitute a biological link between~     the two diseases. Inflammatory cytokines increase vascular permeability, change~     vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate~     thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and~     impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an~     important step in the development of atherosclerosis, and adhesion molecules, such as~     intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process.~     Therefore, identifying novel therapeutic approaches that would favorably affect~     inflammation, endothelial function, and glucose is of significant interest. Investigators~     have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a~     significant reduction in plasma levels of various inflammatory markers and cell adhesion~     molecules. The results also suggest that the beneficial effects of sitagliptin on both~     inflammation and endothelial function are most likely mediated by an elevation in plasma~     GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the~     mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be~     fully elucidated. The proposed study will address this key issue.~   "
39784|NCT02536235|"~     Paracervical blocks are routinely used in first trimester surgical abortions and are a~     proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an~     overwhelming majority of women still report at least moderate pain during a first trimester~     abortion procedure. Other than some non-pharmacologic modalities (music and visualization),~     only the addition of intravenous medication has been shown to reduce procedural pain.~     Applied topical heat is effective in alleviating pain in other medical subspecialties, and~     in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied~     for intraoperative pain control during first trimester abortion.~      The investigators plan to conduct a double-blinded, randomized, controlled trial~     investigating the utility of topical heat application as an adjunct to paracervical block in~     first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score,~     measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators~     will look at the effect of heat application on pain at time of speculum placement,~     paracervical block, tenaculum placement, cervical dilation and overall pain. Patient~     satisfaction will also be assessed. If found to reduce pain during abortion under local~     anesthesia, the use of heat could offer an inexpensive, safe and universally available~     adjunct to the paracervical block during this procedure.~   "
39834|NCT02535585|"~     The shoulder is the joint that most commonly suffers dislocation, and anterior instability~     is the most frequent form. Arthroscopic repair is the gold standard for the treatment of~     recurrent shoulder dislocation. The most commonly used technique is the attachment of~     glenoid labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the~     concept of tissue fixation using knotless anchors and its applicability for GLLC lesions.~     Some researchers have published studies using knotless anchors and have compared this~     technique to the use of knotted anchors, demonstrating similar reconstruction of labral~     height and functional outcomes, while the recurrence rate is still contradictory. To date,~     there are no prospective randomized controlled clinical trial comparing these two techniques~     of GLLC repairs.~      The researchers aims to compare clinical outcomes and imaging evaluation of patients~     undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted~     anchors.~   "
39785|NCT02536222|"~     The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou~     districts) and Louga (Linguère district), that were selected in 2014 on the basis of the~     malaria incidence rate, the heterogeneity of transmission between villages in the health~     post catchment areas, their proximity, and the availability of historical data from before~     2014. Malaria elimination strategies were already implemented in the same health posts in~     2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven~     health posts with similar characteristics but with a slightly lower incidence rate were~     chosen as controls. It will be implemented in all villages in the six intervention health~     posts and it will consist of investigating all passively detected cases (index cases) and~     conducting focal test and focal drug administration (FT/FDA) with~     dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a~     positive RDT. All household members in households with a positive RDT will be treated,~     regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and~     prevalence will be evaluated using before-after comparison and compared to the change in the~     control health posts and the operational aspects will be assessed for subsequent scale up.~   "
39786|NCT02536209|"~     The purpose of this study is to investigate the pharmacodynamic effect of single doses of~     MT-8554 in healthy subjects.~   "
39787|NCT02536196|"~     The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce~     the amount of embolic material that may enter the carotid, subclavian, and vertebral~     arteries during transcatheter heart valve implantation.~      The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic~     deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in~     comparison with an active control group of patients undergoing unprotected TAVI.~      Subjects with indications for TAVI and who meet study eligibility criteria will be~     randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device~     (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected~     transcatheter aortic valve implantation.~   "
39788|NCT02536183|"~     This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2~     dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination~     with MR-HIFU in children with relapsed/refractory solid tumors, which may include but are~     not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of~     tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors.~   "
39789|NCT02536170|"~     The aim of this study is to determine whether giving extra arginine, a simple amino acid, to~     patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive~     painful events (VOE) will decrease pain scores, decrease the need for pain medications or~     decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.~   "
39790|NCT02536157|"~     Which splinting method produces the best outcomes (in range of movement, pain and function)~     in the non-operative treatment of stable volar plate injuries in adults?~      The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint~     - PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball~     hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the~     injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using~     thermoplastic material. However, there is a potential risk of developing permanent stiffness~     of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk,~     the study aims to investigate if using a volar (on the front of the finger) gutter splint in~     0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. There~     is no existing high-quality evidence comparing these two methods.~      This is a randomised controlled trial. For the purposes of this study, the current treatment~     of a 20° dorsal block splint will act as the control group. The intervention group will be~     the volar gutter splint group. A convenience sample will be used and all patients (over 16~     years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be~     invited to participate in the study, with consideration to inclusion/exclusion criteria.~     Participants will be randomised into one of two groups through the use of a random number~     generator. The outcomes assessed will be range of movement, pain and function. These will be~     measured at initial assessment, four and twelve weeks. These are all average normal time~     intervals that patients are seen. Each splint is worn for four weeks and participants will~     receive standardised advice, exercises and treatment.~   "
39791|NCT02536144|"~     This study is to determine the feasibility and safety of magnetic-controlled capsule~     endoscopy system in examination of human colon under the real time monitoring by colonoscopy~     in the clinical application.~   "
39792|NCT02536131|"~     Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and~     psychological variables in patients with irritable bowel syndrome and inflammatory bowel~     disease undergoing gut-directed hypnotherapy (GHT).~   "
39793|NCT02536118|"~     Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of~     the Micra Transcatheter Pacing System (Micra system) when used as intended, in real-world~     clinical practice, following commercial release. The Micra Registry is conducted within~     Medtronic's post-market surveillance platform.~   "
39794|NCT02536105|"~     The purpose of this study is to evaluate the association between blood drug levels and the~     corresponding scores of commonly used behavioral instruments based upon data collected~     following administration of three different methylphenidate hydrochloride extended-release~     drug products in children with ADHD.~   "
39795|NCT02536092|"~     To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite~     and 1064nm Nd:YAG laser for hair removal.~   "
39796|NCT02536079|"~     The NeST registry is a pro-active industry-academic collaboration to assess the use and~     safety of NeuroAiD in the real world setting. An online entry system was set up to allow~     easy data entry and retrieval of clinical information.~   "
39853|NCT02535338|"~     This phase I/II trial studies the side effects and best dose of heat shock protein 90~     (Hsp90) inhibitor AT13387 when given together with erlotinib hydrochloride and to see how~     well they work in treating patients with EGFR-mutant non-small cell lung cancer that has~     come back (recurrent) or has spread to other places in the body (metastatic). Erlotinib~     hydrochloride and Hsp90 inhibitor AT13387 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
39797|NCT02536066|"~     The postprandial blood glucose concentration is an important risk factor for development of~     cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate~     or light post-meal physical activity effectively blunts the postprandial increase in blood~     glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus,~     the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very~     light physical activity decreases postprandial glycemia when performed in the postprandial~     period. The purpose of this study was to investigate whether such activity performed each~     day for 12 weeks would influence blood variables related to glycemic control.~      METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an~     intervention or a control group. They were previously diagnosed as hyperglycemic, or with~     high risk of type 2 diabetes according to Ramachandran's risc score.~      Control subjects were told to maintain their usual physical activity patterns during the~     study period, while the intervention subjects were instructed to undertake a minimum of 30~     minutes of daily post-meal physical activity in addition to their usual activity patterns.~      Venous blood samples were taken before and after the 12 week intervention period. Plasma was~     analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and~     c-peptide. The subjects kept a physical activity diary, answered questionnaires and used~     accelerometers to determine the level of physical activity.~   "
39798|NCT02536053|"~     This study aims to:~        1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto~          Extremity Salvage Score lower extremity sections and to~        2. assess the functional ability and health-related quality of life (HRQoL) of lower~          extremity sarcoma patients who have undergone limb salvage surgery.~   "
39799|NCT02536040|"~     This study is being conducted to test whether the use of diammine silver fluoride (also~     called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.~   "
39800|NCT02536027|"~     The plasma level of neutrophil gelatinase-associated lipocalin (NGAL) in critically ill~     patients with AKI is not affected by continuous venovenous hemofiltration (CVVH). However,~     it remains unclear if this also applies to sepsis-induced AKI, as considerable evidence~     suggests that the pathophysiology of septic AKI is different from other causes of AKI.~   "
39801|NCT02536014|"~     Sympathetic activity could be increased during robot-assisted laparoscopic radical~     prostatectomy, which is performed in a steep trendelenburg position under CO2~     pneumoperitoneum.~      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the~     susceptibility to life threatening cardiac arrhythmias.~      Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties.~     Perioperative administration of dexmedetomidine is a potential preventive and treatment~     strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of~     dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic~     radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and~     Tp-e/QTc ratio as well.~   "
39802|NCT02536001|"~     The purpose of this study is to compare anatomical differences, quality of life and sexual~     function and complications rate between apical support with one anterior vaginal mesh versus~     repair with two separate meshes.~   "
39803|NCT02535988|"~     Patients with colorectal cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer~          patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer~          patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic esophageal cancer.~   "
39804|NCT02535975|"~     This is a prospective, randomized, double-blind, placebo-controlled study about the effect~     of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild~     ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three~     times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months~     after withdrawal of treatment.~   "
39805|NCT02535962|"~     The purpose of study is to see if adding probiotics to corticosteroid treatment for children~     with PFAPA could improve the health and daily of patients through reduction in febrile~     period frequency and length, along with concomitant reduction of associated symptoms.~     Current standard of care incorporates the administration of corticosteroids; however, while~     limiting the symptoms associated with PFAPA, corticosteroid use has been shown to increase~     the frequency at which these symptoms occur. Investigators hypothesize that administration~     of probiotics along with corticosteroids will work to decrease the frequency at which the~     febrile episodes occur. Additionally, probiotics may decrease the maximal fever experienced~     during these episodes, amount of corticosteroid needed to control the symptoms, average~     length of the episodes, and the number of patients who ultimately undergo tonsillectomy due~     to unsuccessful treatment with medication.~   "
39806|NCT02535949|"~     The purpose of this study is to evaluate the effects of TXA on the immune system, its~     pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.~   "
39807|NCT02535936|"~     The purpose of this study is to characterize the cortical connectivity changes in the brain~     of spastic diplegic children after Selective Dorsal Rhizotomy.~   "
39808|NCT02535923|"~     The goal of this project is to develop guidelines for the clinical tailoring of Cognitive~     Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia,~     and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving~     sleep-related functional outcomes in this population.~   "
39809|NCT02535910|"~     This study aims to compare the acute effect of consuming milk and butter fortified with~     either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the~     effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and~     cognitive function will be examined.~   "
39810|NCT02535897|"~     The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the~     absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and~     carbohydrate-only controls, and to determine whether increasing plasma carnitine~     availability can impact upon insulin-stimulated muscle carnitine uptake.~   "
39813|NCT02535858|"~     Anxiety is one of the major influences on relapse and substance abuse treatment dropout.~     Chemically dependent individuals need to be aware of their emotional state in situations~     that jeopardise their treatment. The current therapeutic resources still subjective and with~     limited treatment success. This research presents a developed virtual environment (VE)~     simultaneously connected to a physiological signals device acquisition that allows, through~     a biofeedback, the chemically dependents consciousness on their vulnerability front~     different situations of 'risk', without a direct assessment of the therapist. Developed in~     3ds Max® software, the VE is composed of scenarios and objects that are in the habit of the~     chemically dependent individual's daily life. The interaction with the environment is~     accomplished using a Human-Computer Interface (HCI) that converts incoming physiological~     signals indicating anxiety state into commands that change the scenes. Anxiety is~     characterized by the average variability from both heart and respiratory rate of 30~     volunteers undergoing stress environment situations. To evaluate the effectiveness of the VE~     as a biofeedback of chemically dependent's vulnerability front situations of risk, a total~     of 50 volunteers who were drug users, monitored by 10 therapists, were enrolled. Prior VE,~     the results demonstrated a poor correlation between the therapists' predictions and those of~     the chemically dependent individuals. After exposure to the VE, there was a significant~     increase of 73% in awareness of the risks of relapse by the chemically dependent~     individuals, confirming the hypothesis that the VE coupled to the biofeedback device may~     assist the therapist with treatment.~   "
39814|NCT02535845|"~     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true~     among traditionally underserved adolescents. Few parent-targeted interventions have focused~     on the parental decision-making process. Self-persuasion, generating one's own arguments for~     engaging in a behavior, may be an effective means to influence parents' motivation to~     vaccinate their children. In a three-phase study, investigators are using quantitative and~     qualitative research methods to develop and refine a tablet-based self-persuasion~     intervention for parents who are undecided about the HPV vaccine. This clinical trial~     submission focuses on the third phase of the study (the second stage is also registered in~     clinical trials).~   "
39815|NCT02535832|"~     Muscle strength helps determine a person's quality of life and functional independence.~     Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic~     condition called insulin resistance.~      By doing this study, the investigators hope to learn why patients with rheumatoid arthritis~     (RA) suffer from muscle weakness.~   "
39816|NCT02535819|"~     Cataract is the clouding of the lens of the eye, which initially prevents clear vision and~     eventually progresses to blindness if left untreated. Cataract remains the leading cause of~     blindness and an important cause of visual impairment across the globe. Cataract surgery by~     ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)~      Two sub-categories of phacoemulsification coexist :~      Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and~     Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The~     corneal endothelium plays an important role in maintaining the dehydrated state and the~     transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all~     types of cataract surgery but the amount of endothelial cell loss may varies with the type~     of surgical technique The aim of the study is to evaluate the density of the central corneal~     endothelial cells before and after cataract surgery comparing two phacoemulsification~     techniques (Divide-and-Conquer vs Subluxation)~   "
39817|NCT02535806|"~     This is a phase II study designed to investigate the combination of bortezomib with the~     mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients~     with high risk ALL relapse including early bone marrow relapse and second or greater relapse~     of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be~     performed after blood counts recover to assess the rate of CR (<5% bone marrow blasts) and~     MRD status in children following this regimen. Further treatment with or without HSCT will~     be at the discretion of the primary physician.~   "
39818|NCT02535793|"~     Allergy is a very common problem and can be a handicap in everyday life, specially when~     symptoms occur at work place. Some persons working with drosophila developed respiratory~     symptoms. Investigators tried to analyze if these manifestations could be due to a specific~     allergy to drosophila.~   "
39819|NCT02535780|"~     The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation~     (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation~     alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct~     Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN~     and BN groups.~   "
39820|NCT02535767|"~     The purpose of this study is to determine the highest tolerable dose of primaquine within~     0.75 mg/kg. A tolerable dose is defined as one in which:~        -  Two or fewer participants (< 30%) experience hemolysis;~        -  No participant experiences a drug-related serious adverse event; and~        -  No participant requires a blood transfusion.~   "
39821|NCT02535754|"~     Behaviour changes such as improving nutrition, increasing physical activity, and decreasing~     obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion~     programs in the workplace are a promising way to reach a large segment of the population.~     This project evaluated the efficacy of three approaches - all of which were based on~     previous research and programs with demonstrated positive benefits - on cancer-related~     outcomes (healthy eating, physical activity, normal body weight) and work-related outcomes~     (absenteeism, presenteeism).~   "
39822|NCT02535741|"~     An open label, post-market, non-randomised, historical controlled, multi-centre study of the~     outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.~   "
39823|NCT02535728|"~     A prospective observational cohort study to assess the predictive value of preoperative~     frailty on postoperative quality of life in cardiac surgery patients.~   "
39824|NCT02535715|"~     ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the~     present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate~     this novel insulin preparation as a potential therapeutic option in diabetic patients.~   "
40858|NCT02522208|"~     This study will investigate cardiovascular parameters using echocardiographic and~     pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a~     study drug free day.~   "
39825|NCT02535702|"~     Background:~      Abusing alcohol, drugs, and other substances can cause serious health problems. These~     substances also can affect brain function. Researchers want to learn more about brain~     function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio~     waves to take pictures of the brain.~      Objective:~      To develop new ways to use MRI to study the brain.~      Eligibility:~      Healthy people 18 years of age or older.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests.~      They will answer questions about their drug use and psychiatric history. They will be asked~     about family history of alcoholism or drug abuse.~      Participants will answer questions to see if they can participate in MRI.~      Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic~     field. Participants will lie on a table that slides in and out of the cylinder. A device~     called a coil may be placed over the head.~      Each sub-study will include up to 3 different MRI visits. Participants can be in multiple~     sub-studies. But they can have only 1 MRI per week and 20 per year.~      During MRI visits, participants may have urine collected. They may get another MRI~     questionnaire.~      Participants may have a clinical MRI brain scan. This may show physical problems in the~     brain.~      During some scans, participants may perform simple movement, memory, and thinking tasks.~      Participants may be connected to a machine to monitor brain activity during the scan. Small~     metal electrodes will be placed on the scalp. A gel will be placed in the space between the~     electrodes and the scalp.~   "
39826|NCT02535689|"~     Background:~      Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many~     systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious~     lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can~     have serious side effects. Also, the drugs don t help some people. Researchers want to find~     new, more effective and safe treatments.~      Objective:~      To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with~     lupus.~      Eligibility:~      People ages 18 and older who have mild to moderate lupus and are not currently or haven t~     recently had certain lupus treatments.~      Design:~      Participants will be screened in another protocol.~      Participants will have 7 five-hour visits over about 3 months. They will fill out multiple~     questionnaires. They will have tests, including:~        -  Physical exam~        -  Blood and urine tests~        -  ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart.~        -  Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure~          and flow speed.~        -  Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A~          cuff is put on the arm to measure blood pressure and flow.~        -  Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the~          chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure~          and velocity.~      Participants will receive either the study drug or a placebo. They will take this twice a~     day by mouth for 56 days.~      Participants will be contacted by phone 4 times.~   "
39827|NCT02535676|"~     The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct~     current stimulation) for treatment of negative symptoms in patients with schizophrenia. The~     proposed design is a clinical trial, randomized, double-blind, placebo-controlled study.~     Participants will receive ten sessions of active or sham stimulation in five consecutive~     days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be~     assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the~     investigators expect to see a clinical improvement of negative symptoms through scales PANSS~     (Positive and Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS~     (Skills for Assessment of Negative Symptoms), and expect improvement on computerized~     cognitive tests. Another goal is to see improvement in biological markers related to~     schizophrenia, plasma and DNA will be stored.~   "
39828|NCT02535663|"~     To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in~     Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and~     circulating cytokine levels.~   "
39829|NCT02535650|"~     Platinum-based chemotherapy is now regarded a standard first-line treatment for patients~     with advanced urothelial carcinoma (UC). However, patients who failed to response or~     experienced progression after platinum-based chemotherapy have a grim prognosis and a~     standard salvage treatment is not available.~      UC is known to harbor multiple mutations. In the investigators' own high-throughput~     molecular profiling study, the most commonly observed mutations included TP53,~     FGFR3(fibroblast growth factor receptor 3 ) and HRAS. Since RAS signaling can be attenuated~     using selective farnesyl transferase (FTase) inhibitors, tipifarnib, a highly potent and~     selective inhibitor of FTase, was proposed to be an effective therapeutic approach in the~     treatment of UC.~   "
39830|NCT02535637|"~     The purpose of this study is to explore the effect maternal obesity and breastfeeding play~     on infant body composition. The investigators hypothesize in the first 6 months of life~     breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat~     mass and accumulate fat at a greater rate than breast fed infants from normal weight~     mothers. Furthermore, the investigators postulate that circulating maternal milk~     adipocytokines will positively correlate to total fat mass at six months of age.~   "
39831|NCT02535624|"~     This study is designed to answer whether minimal invasive vessel clotting~     (angioembolization) or open surgery (retroperitoneal packing) is more effective for pelvic~     fractures with massive bleeding. Patients admitted at daytime (7am-5pm) are treated with~     angioembolization while patients admitted at nighttime (5pm to 7am) are treated with open~     surgery.~   "
39832|NCT02535611|"~     The researchers aim to investigate the effect of memantine on stroke outcome in a randomized~     double-blind placebo-controlled clinical trial.~   "
39833|NCT02535598|"~     This project aims to investigate factors that are important in affecting adherence in~     internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two~     intervention-specific variables, Support and Content, are important factors and that~     maximizing the impact of these would result in improved adherence and potentially in the end~     also better outcome for participants in internet interventions.~   "
40011|NCT02533271|"~     The purpose of this study is to compare effectiveness of short-term radiotherapy with~     neoadjuvant chemotherapy(Experimental group) with preoperative long-term~     chemoradiotherapy(Control group) in locally advanced rectal cancer. The hypothesis is 3-year~     disease-free survival in Experimental group was non-inferior to that in Control group.~   "
39835|NCT02535572|"~     This open label investigation further evaluates the safety, efficacy and potential~     mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators~     have recently completed preliminary open-label studies with FEAST, first at Columbia~     University, and then at the Medical University of South Carolina in Charleston (Nahas et~     al., 2013b). The investigators have published the outcomes of the first 17 patients studied.~     One patient withdrew from the study after a single titration session. After the course of~     FEAST (median 10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale~     for Depression (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P < 0.0001).~     Eight of 16 patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission~     criteria (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 +~     6.4 min (median time = 3.6 min), timed from when their eyes first opened after treatment.~     The investigators have now studied 18 more patients (see results below), and we are~     completing the study in the original IDE with another two more patients still to enroll.~      This work allowed us to refine the treatment. For example, the investigators selectively~     modified the electrode geometry to decrease interelectrode resistance. Additionally the~     investigators modified the titration schedule, now only administering a standard 800 ma~     ultrabrief pulse, and thus no longer titrating in the current domain.~      In this next proposed trial we will continue to gather efficacy and safety data, and compare~     these to a parallel non-randomized group receiving ECT standard of care.~      ECT is typically delivered in a dynamically adaptive manner, with each person having a~     different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus~     have to use imprecise time points such as 'at the end of the acute treatment course' rather~     than specified dates or visits.~   "
39836|NCT02535559|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either~     receive a series of two presentations or wait listed to receive them later in the school~     year.~   "
39837|NCT02535546|"~     Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get~     exacerbations of their illness which have many potential triggers including infection. The~     most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae.~     In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into~     the childhood vaccination programme. This study aims to investigate the carriage rate of S.~     pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae~     found within the COPD population would be covered by the PCV-13 vaccine.~   "
39838|NCT02535533|"~     This is a Phase 1 trial for safety and preliminary efficacy of the combination of axitinib~     and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell~     carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and~     expansion study.~   "
39839|NCT02535520|"~     Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum~     amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature.~     Consented subjects will undergo a series of images of the back of the eye using an Optical~     Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part~     of clinical routine. SSADA images will be compared with conventional methods.~   "
39840|NCT02535507|"~     Various driver gene mutations have been identified in lung cancer. Among them, human~     epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell~     lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2~     receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in~     patients with HER2 positive advanced Non-small cell lung cancer.~   "
39841|NCT02535494|"~     This investigation is one of the first large-scale, prospective attempts to obtain data on~     the effectiveness of naloxone distribution among opioid-abusing populations at high risk of~     unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug~     detoxification sites as well as those accessing services at needle exchange programs. All~     participants (N=700) will receive the standard opioid overdose education and naloxone. One~     third of the participants will be randomized to receive additional in-depth psychosocial~     education focusing on recognition and prevention of opioid overdose, and appropriate use of~     naloxone. Another third of the participants will receive the extensive training and be~     required to engage a spouse, partner, relative, or friend in this supplementary~     intervention. The investigators plan to randomize individuals to each group [Treatment as~     Usual (TAU) vs. Extensively Trained (ET) vs. Extensively Trained with a Significant Other~     (ETwSO)] and, through continued follow up over one year, the investigators will compare~     self-reported overdose reversal attempts (with and without naloxone use), naloxone-related~     adverse events, and changes in patterns of heroin and other drug use.~   "
39842|NCT02535481|"~     Split thickness skin grafting is the normal standard of care for wound closure. However,~     this is an invasive procedure and associated with pain also there can be additional donor~     site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining~     clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin~     grafting that 'harvests' a finer layer of skin than traditional Split thickness skin~     grafting (SSG). This potentially results in less pain and reduced donor site morbidity but~     only delivers several cell layers to the wound so may be less effective at healing a wound.~     It is not known if EG is an effective alternative to SSG.~      Further the mechanism to achieve wound healing may be different. EG promotes wound healing~     by expressing growth factors that accelerates wound healing and encourages keratinocyte~     migration. Whereas SSG is a transplant of several skin layers that integrated to the~     existing wound bed as a formal skin covering.~      The investigators wish to compare these two clinical practises; epidermal grafting and split~     thickness skin grafting in wound healing. Further to undertake a translational study to~     investigate the mechanism by which each technique achieves wound healing.~   "
39843|NCT02535468|"~     The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria~     Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of~     the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status~     of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole~     blood clinical samples.~   "
39854|NCT02535325|"~     This phase I trial studies the side effects and best dose of methoxyamine when given~     together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients~     with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as~     methoxyamine, pemetrexed disodium, and cisplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and~     shrink tumors. Giving methoxyamine together with pemetrexed disodium, cisplatin, and~     radiation therapy may kill more tumor cells.~   "
39844|NCT02535455|"~     Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP)~     among HIV+ substance users, who experience profound health disparities that amplify onward~     transmission risk. This project will systematically develop, refine and conduct an open~     pilot to assess the feasibility and acceptability of a two-phase emotion regulation~     intervention that targets emotional barriers to HIV-related self-care among individuals who~     endorse active substance use. Emotional barriers such as shame and internalized stigma have~     been identified as barriers to optimal HIV care among individuals struggling with HIV and~     substance use. To effectively implement TasP, strategies for addressing these barriers are~     needed. Utilizing transdiagnostic approaches (e.g., positive affect-focused emotional~     regulation, mindfulness and self-compassion) investigators will develop, refine and pilot a~     two-phase emotional regulation intervention that requires only 5 face-to-face hours and can~     ultimately be implemented by a case-management-level staff person or trained peer educator.~     The first phase of the intervention will be a multicomponent in-person intervention~     targeting emotional, cognitive and behavioral barriers to HIV self-care behaviors among HIV+~     substance users. The second phase of the intervention will extend the intervention benefits~     by sending personalized positive self-reappraisal text messages in response to text message~     queries about participants' mood. This phase will use an innovative personalized~     bi-directional platform, which will leverage an existing text message delivery system. This~     project will be instrumental in developing a relatively low-resource intervention strategy~     to address unmet emotional barriers to optimal HIV-care among individuals who are actively~     using substances. This work will provide the necessary pilot data for a subsequent grant~     submission to assess the preliminary efficacy of the intervention. The resulting~     intervention has the potential to address emotional barriers to self-care along the HIV care~     cascade: including retention in care, antiretroviral treatment adherence and persistence,~     and ultimately viral suppression.~   "
39845|NCT02535442|"~     The objective of this study is to evaluate the microbial consortia and the host inflammatory~     factors present in the nasal passages of patients during upper respiratory symptomology and~     when healthy using culture and molecular analysis techniques.~   "
39846|NCT02535429|"~     Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and~     quality of life~   "
39847|NCT02535416|"~     Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.~   "
39848|NCT02535403|"~     Cognitive behavioral therapy (CBT) is a well-documented and effective method for the~     treatment of children and adolescents with anxiety disorders. Lately there has been an~     increase in the development and use of internet-based CBT programs (ICBT), as a means to~     reduce costs and enhance accessibility of psychological interventions. ICBT has proven~     efficacious towards adults with anxiety disorders. Research in the field of ICBT with~     children and adolescents is still in its infancy though and to date, no program targeting~     anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this~     study is to investigate the efficacy of a newly developed internet-based treatment program~     for adolescents with anxiety disorders. The effect will be examined in a randomized~     controlled trial comparing ICBT to a wait-list control condition.~   "
39849|NCT02535390|"~     Major depressive disorder places a tremendous burden on workplace disability each year. Its~     diagnosis is based on the presence of characteristic symptoms that include disturbances in~     mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions~     (e.g., information processing speed, attention, memory, problem solving skills) is absent~     from current diagnostic criteria and off the radar in most clinical treatment settings, yet~     increasingly recognized as a primary cause of poor work functioning and outcomes. This~     disconnect between the root causes of poor vocational outcomes and targets of treatment has~     resulted in a failure to return to work following illness, job underproductivity, and~     work-related stress, which contribute to indirect costs to society each year. The~     investigators seek to expand scientific support for treating neurocognitive impairments in~     order to increase occupational productivity and reduce job-related stress associated with~     depression. The investigators developed a novel group cognitive remediation (CR) treatment,~     Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with~     explicit work-related role-plays to facilitate immediate and salient abstraction of drill~     and practice remediation techniques. The activities were developed in collaboration with a~     community rehabilitation partner in this study through systematic interviews with job~     placement specialists and supervisors from employment sites used by the agency. The props~     match those used in work settings and include miniature versions of a cash register, filing~     system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The~     activities capitalize on procedural learning skills through roleplays and props that~     simulate a work environment. ABCR maintains important aspects of drill and practice,~     strategic monitoring to enhance flexible problem solving approaches, and bridging. The~     role-plays follow computerized drill and practice exercise and therapists facilitate group~     discussions of how cognitive skills and flexibility in thinking from drill and practice can~     be effective while directly engaged in an everyday work environment. Thus, bridging used in~     ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the~     treatment from standard CR, where the discussion-based approach is limited by the auditory~     learning, memory, and abstraction deficits observed in depression.~   "
39850|NCT02535377|"~     Sperm freezing has been employed for decades for male fertility preservation in cases of~     foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a~     complement of assisted reproduction techniques.~      Sperm quality after thawing is highly variable, even among consecutive samples from the same~     individual, with mean survival rates around 40%. To date, the molecular basis of the~     adequate resistance or intolerance to freezing/thawing protocols is unknown, and its~     knowledge can lead to improvement in the selection of the samples to be frozen and also in~     the adequate supplement of cryopreservation media. Microarray analysis provides a powerful~     tool to address the molecular explanation beyond this behaviour, yielding results about~     comparative messenger ribonucleic acid (mRNA)expression under the two different biological~     conditions: optimal and suboptimal survival.~      Then, the aim of the investigators' study is to determine the genomic profile of sperm~     samples depending on their survival resistance to cryopreservation, to determine genes~     involved in cryodamage sensitivity.~   "
39851|NCT02535364|"~     This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or~     refractory B-ALL with an infusion of the patient's own T cells that have been genetically~     modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that~     express the CD19 protein on the cell surface. The study will determine if these modified T~     cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial~     will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the~     patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the~     impact of this treatment on survival.~   "
39852|NCT02535351|"~     Two randomized trials in the cytokine era clearly showed that cytoreductive nephrectomy (CN)~     had a role in metastatic renal cell carcinoma (mRCC) increasing life expectancy. The~     survival benefit of tyrosine kinase inhibitors (TKIs) including first-line sunitinib and~     pazopanib in mRCC has been demonstrated, but the majority of patients enrolled in the~     pivotal phase III studies had undergone nephrectomy.~      Therefore it is unknown if similar survival benefit could be achieved without CN with these~     new targeted agents.~      At the same time there is a need to better understand mechanisms of primary and secondary~     resistance to TKIs in mRCC patients and to identify eighter prognostic and predictive~     biomarkers to better define risk factors and potentially druggable targets.~   "
39868|NCT02535130|"~     The purpose of this study is to compare the efficiency of nebulization and positive~     expiratory pressure combination~   "
39855|NCT02535312|"~     This phase I/II trial studies the side effects and the best dose of methoxyamine when given~     together with cisplatin and pemetrexed disodium and to see how well it works in treating~     patients with solid tumors or mesothelioma that have spread to other places in the body and~     usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma~     that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory).~     Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work~     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such~     as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a~     better treatment for solid tumors or mesothelioma.~   "
39856|NCT02535299|"~     Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide;~     in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about~     telomere-telomerase system and Par-4.~   "
39857|NCT02535286|"~     The purpose of this study is to evaluate the safety and effectiveness of pembrolizumab in~     combination with ublituximab and TGR-1202, in patients with advanced CLL.~   "
39858|NCT02535273|"~     Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under~     local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether~     or not can reduce the amount of local anesthetics.~   "
39859|NCT02535260|"~     This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home~     setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) by~     female volunteers seeking to get pregnant.~   "
39860|NCT02535247|"~     This is a multicenter, single-arm, open label 2-stage phase 2 study exploring monotherapy~     with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of~     200mg every 3 weeks for up to 36 cycles for patients with relapsed or refractory Peripheral~     T-cell Lymphoma (PTCL), who have received at least 1 prior systemic therapy. The primary~     endpoint of the study is progression-free survival. Secondary outcomes are overall survival~     and response rate. Patients will be assessed for response with PET CT or CT every 12 weeks~     using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1~     expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional~     assays; PD-1 and PD-L1 expression on tumor tissue; and tumor infiltrating lymphocytes as~     prognostic and predictive biomarkers.~   "
39861|NCT02535221|"~     This study proposes to prove that the efficacy of adjuvant endocrine therapy for the~     premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy~     assessed by ultrasound response rate.~   "
39862|NCT02535208|"~     The primary aim of this study is to determine the mean number of red blood cell (RBC)~     transfusions received by preterm infants cared for using restrictive Hgb guidelines in~     combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the~     mean number of transfusions received by preterm infants cared for using liberal guidelines~     alone.~      This study is designed as a prospective randomized controlled trial. Preterm infants less~     than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled~     into the study during day of life 0 to 3. Study participants will be randomly assigned into~     two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal~     group, RBC transfusions will be given to subjects when their Hgb level falls below defined~     values that are based on respiratory support status. In the restrictive group, RBC~     transfusions will be given to subjects either when their Hgb level falls below defined~     values based on respiratory status or, despite not having reached their Hgb trigger~     threshold, if they manifest symptoms judged by the clinical care team to be consistent with~     anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a~     near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR < 0.73.~   "
39863|NCT02535195|"~     The hypothesis of this study was that ginger supplement consumption can be introduced as a~     new therapeutic strategy for non-alcoholic fatty liver disease through the improved body~     antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized~     double-blind study was designed to evaluate this hypothesis in order to examine the~     effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.~   "
39864|NCT02535182|"~     This is a an ancillary study designed to explore whether an additional cell signaling~     pathway (prenylation of Rap1) that was recently identified as being under beta-adrenergic~     control may be affected by beta-blocker use.~   "
39865|NCT02535169|"~     This study looks as how a health education intervention strategy effects health outcomes in~     overweight and obese adolescents.~   "
39866|NCT02535156|"~     Neurophysiological indices of self-monitoring were assessed in a group of patients with~     Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after~     the administration of risperidone and placebo.~   "
39867|NCT02535143|"~     This study aims to test the hypothesis that there was a relationship between the consumption~     of energy drinks and the manual dexterity skills of final year dental students.~      Identification of baseline caffeine consumption and selection of sample Baseline caffeine~     consumption will be identified by distributing the caffeine consumption questionnaire to all~     the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will~     recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of~     nicotine consumption, the study will only recruit non-smokers .female candidates taken oral~     contraceptives and Subjects with any history of renal disease will be excluded.~      All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece~     (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut~     the cavity in each test both cavities will be selected for assessment. The ability of the~     participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the~     task will be used as criteria to evaluate dexterity. The participants will be required to~     perform the test before and 30 minutes after energy drink exposure.~      Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last~     meal in the other hand the control group will be receiving a placebo drink .~      Dexterity outcomes will be compared before and after exposure to the energy drink using the~     paired t test. Outcomes will be compared between different groups and different time~     intervals using the two way, multiple measures ANOVA. All data will be analyzed using the~     SPSS ver.21 data processing software.~   "
39869|NCT02535117|"~     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death~     from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC~     accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to~     the lack of donors Recurrence of tumor within the liver remnant is also common, with a~     reported 5-year recurrence rate of 50-70%, in patients who have undergone curative~     hepatectomy. Management of recurrent HCC is still urgent and several treatments have been~     developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a~     5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only~     in a small proportion of patients with HCC recurrence due to the poor functional liver~     reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after~     treatment, radiofreqency ablation (RFA) has been used as an effective treatment for~     recurrent HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to~     those achieved by surgery. Laparoscopic surgery was considered not to be a suitable~     treatment for recurrent HCC due to postoperative adhesions that can make laparoscopic~     surgical procedure more difficult and less safe. Recently, several studies reported that~     laparoscopic surgery for recurrent HCC in cirrhotic patients is a safe and feasible~     procedure with good short-term outcomes. By far, no study has been performed to compare the~     efficacy and safety of laparoscopic surgery with RFA for treatment of recurrent HCC.~   "
39870|NCT02535104|"~     Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical~     treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety~     of a topical formulation of ranpirnase in subjects with genital warts.~   "
39871|NCT02535091|"~     This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089~     as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking~     phenytoin or phenobarbital will be enrolled followed by additional subjects taking~     anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term~     safety.~   "
39872|NCT02535078|"~     This study is a Phase Ib/II, multi-center, open-label study of IMCgp100 as a single agent~     and in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous~     melanoma. The purpose of this study is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of IMCgp100 in combination~     with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab~     (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to~     single-agent IMCgp100 alone. The study will enroll patients who have metastatic melanoma~     that is refractory to treatment with an anti-PD-1 inhibitor as well as patients naive to~     therapy in the metastatic setting.~      Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1)~     directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus~     therapies such as IMCgp100 that recruit these effector cells to the tumor may overcome~     pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint~     inhibitor resistance suggests the combination of IMCgp100 with checkpoint inhibition may~     have enhanced activity in patients with pre-existing resistance.~   "
39873|NCT02535065|"~     The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study~     the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in~     conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic,~     aortoiliac, and iliac aneurysms.~   "
39874|NCT02535052|"~     This study will investigate the function of the immune system in people with chronic kidney~     disease (CKD) compared to people with normal kidneys. The investigators will use standard~     vaccines - the seasonal flu vaccine and pneumococcal polysaccharide (Pneumovax) vaccine - to~     examine how the immune system responds to challenge. All subjects will receive these~     recommended vaccines as part of routine care. Blood and urine samples will be collected and~     tested at different time points to look at how the immune response develops to these~     vaccines and if there are any differences between people with CKD and those without. This~     will help us understand how CKD affects the function of the immune system.~   "
39875|NCT02535039|"~     Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous~     system complications after general anesthesia and clinical manifestations of mental~     disorder, anxiety, personality changes, impaired memory, personality, social skills and~     cognitive function after surgery for this decline is called postoperative cognitive~     dysfunction.Due to the lack of effective clinical treatments, how to prevent and solve the~     postoperative cognitive dysfunction has become a difficulty and a focus of research in the~     field of anesthesia.Methylprednisolone is a new type of cortical hormone, because of its~     strong anti-inflammatory effect, less adverse reactions, is widely used in clinical~     anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical~     application and achieved good curative effect in practice.In this paper by comparing brain~     oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on~     cognitive function in patients with grade indexes, such as observation of methylprednisolone~     combined electric acupuncture treatment of elderly patients with general anesthesia early~     after the operation, the influence of cognitive function.~      Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes,~     Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade~     indexes, such as observation of methylprednisolone combined electric acupuncture treatment~     of elderly patients with general anesthesia early after the operation, the influence of~     cognitive function.~   "
39876|NCT02535026|"~     This is a descriptive, prospective, observational and epidemiological study on participants~     recently diagnosed with breast cancer to evaluate the human epidermal growth factor receptor~     2 (HER2) status by immunohistochemistry (IHC) and silver in-situ hybridization (SISH)~     procedures.~   "
39877|NCT02535013|"~     Investigators hypothesized that perioperative lung ultrasound would be beneficial in~     pediatric patients undergoing cardiac surgery compared to those who did not receive lung~     ultrasound.~   "
39878|NCT02535000|"~     Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation~     with fentanyl demand controlled by the patient. The primary objective is to evaluate the~     efficacy of duloxetine in fentanyl consumption during the postoperative period of patients~     undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints~     were pain scores and the presence or absence of adverse effects such as headache, nausea,~     vomiting, itching, dizziness and drowsiness.~   "
39879|NCT02534987|"~     As the nation continues its efforts to contain healthcare costs and improve quality,~     healthcare information technology provides some of our most potent yet underutilized tools.~     Clinical prediction rules are frontline decision aids that combine state-of-the-art evidence~     with real-time patient history, physical examination, and laboratory data. While often~     well-validated, clinical prediction rules have been underutilized in practice. Recently, our~     team developed the integrated clinical prediction rule (iCPR) system, embedding CPRs within~     the nation's largest commercial electronic health record (EHR) system. Using this novel~     system, we demonstrated high rates of provider utilization and a significant reduction in~     antibiotic prescribing and diagnostic test ordering among suspected cases of strep throat~     and pneumonia at a single healthcare facility. The objective of the proposed project is to~     generalize this platform across diverse settings and create a toolkit for further~     dissemination. Building on the success of the original iCPR project, the specific aims of~     this proposal are to (1) integrate our previously tested and refined iCPR tool into the same~     commercial EHR in three different clinical settings, adapting the innovation to provider~     preference, culture, and local workflow rather than imposing a rigidly standardized tool,~     (2) identify and measure rate and variability of iCPR uptake across different settings, (3)~     determine iCPR impact on antibiotic prescribing and diagnostic test-ordering patterns across~     diverse clinical settings with a randomized controlled trial, and (4) use a well-established~     theory-driven implementation framework to identify facilitators and barriers to integration~     in each setting, and develop a toolkit for adapting and implementing the tool in diverse~     settings. To achieve these aims, we propose a five-year study in which we first adapt,~     integrate and usability-test the original iCPR at three new diverse sites. We will then~     conduct a two-year randomized controlled trial with a one-year post-trial open-access~     observation period to determine the persistence of: 1) the tool's utilization and 2) its~     impact on antibiotic- and test-ordering in patients with suspected strep throat or~     pneumonia. In the final year, study findings will be compiled into a toolkit so that any~     healthcare facility using the Epic EHR can integrate iCPR into its ambulatory workflow. The~     study uses several innovative and significant approaches, including: 1) adapting the~     nation's most widespread commercial EHR system; 2) building the new tool with~     off-the-shelf technology included in every Epic EHR package, so the innovation can be~     easily ported to all Epic EHR users; 3) using highly specific, well-validated clinical~     prediction rules as its core content; 4) guiding the integration process with highly~     generalizable usability testing techniques; and 5) using a hybrid RE-AIM and normalization~     process theory implementation evaluation framework. Together, these innovative approaches~     make iCPR uniquely suited to overcome longstanding barriers and integrate and disseminate~     evidence-based tools into the primary care workflow at the point of care in real time.~   "
39880|NCT02534974|"~     Ventilation-associated pneumonia is the main site of healthcare-associated infections in the~     severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia~     increases morbi-mortality, length of stay in intensive care and overall management costs. As~     was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of~     nosocomial infections contracted in intensive care, success in this preventive endeavour~     depends on a number of measures: orotracheal intubation route, maintaining tube cuff~     pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and~     oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use~     of a written sedation-analgesia algorithm allowing for early weaning from ventilation.~      Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in~     maintaining tracheal balloon pressure than intermittent adjustments using a hand-held~     manometer. In one study, these devices clearly facilitated diminution of microaspiration of~     gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22~     VAP/1000 days of mechanical ventilation; p = 0.005).~      The investigators are putting forward the hypothesis that by adjoining a device providing~     continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at~     ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°,~     oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP~     incidence by 50% in severely traumatised patients whose condition necessitates mechanical~     ventilation of an expected duration exceeding 48h.~      Ours is the first large-scale study to evaluate the interest of an innovative technology~     bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care~     populations the most at risk, namely severe trauma patients, a population presently~     benefiting from the other recommended preventive measures.~   "
39881|NCT02534961|"~     This randomized prospective study aims to investigate whether prophylactic administration of~     antibiotics has an influence on inflammatory markers, liver function test results, or the~     incidence of post-procedural infection in patients with hepatocellular carcinoma (HCC)~     undergoing radiofrequency ablation (RFA).~   "
39882|NCT02534948|"~     Anxiety and depressive disorders are common in all regions of the world. Anxiety disorders~     are considered as third major psychological issue in Pakistan (Panhwer, 2014). Objective of~     the present study is to see the feasibility and effectiveness of social anxiety in females~     with the help of mindfulness and acceptance based therapy. It is hypothesized that women in~     the intervention group will have significantly reduced anxiety as compared to the women in~     the control group. A total of 60 females in the age range of 18 to 28 ages will be selected~     from Institute of professional psychology and private clinics from Karachi city. The~     participants will be recruited through the administration of Mini-Social Phobia Inventory~     (SPIN-mini). The participants will be randomly divided in interventions and control group~     and will receive the intervention of ten sessions of group therapy of MABT plan. Assessment~     will be conducted at the baseline and at the end of the intervention.~   "
39883|NCT02534935|"~     The purpose of this study is to investigate the immunogenicity, safety and tolerability of a~     new vaccine that might prevent meningococcal B disease. The study will be conducted in~     healthy toddlers aged between 12 and 24 months.~   "
39884|NCT02534922|"~     This trial is a Phase I open-label safety study of Prolanta™, a recombinant analog of the~     human prolactin protein with a single amino acid substitution to create an antagonist of the~     prolactin receptor. The Sponsor believes that blocking the prolactin receptor in patients~     with ovarian and other cancers will be effective as a monotherapy or in combination with~     other chemotherapies. This Phase I study will be conducted in Subjects with recurrent or~     persistent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~   "
39885|NCT02534909|"~     To determine whether LFG316 can induce a hematological response, as measured by reduction in~     hemolytic activity, in patients with PNH.~   "
39886|NCT02534896|"~     This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects~     with active rheumatoid arthritis who are experiencing a flare/exacerbation.~   "
39887|NCT02534883|"~     Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours~     pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix~     for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical~     instrument) into the uterus for all operative hysteroscopic procedures requiring dilation~     above 5 mm.~      Time required for cervical dilatation will be recorded. Start time will be when the smallest~     dilator is placed into the endocervical canal, and stop time recorded when the desired~     cervical dilation is achieved with the largest dilator. Depending on the procedure, desired~     dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of~     dilatation.~      The investigators will compare the two groups in terms of medication, resistance, dilation~     time and size, side effects and surgical complications.~   "
39888|NCT02534870|"~     The purpose of this study is to assess the pharmacokinetics and safety of multiple oral~     doses of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting~     conditions in healthy Chinese adult participants.~   "
39889|NCT02534857|"~     In vitro fertilization (IVF) treatment is now commonly used to treat infertile couples.~     During IVF treatment, oocytes and sperm are routinely incubated overnight and this may lead~     to suboptimal culture conditions because of increased reactive oxygen species (ROS) produced~     by sperm in the standard incubation. High levels of ROS can adversely affect the quality of~     the embryos, result in hardening of the zona pellucida and impair the implantation capacity~     of embryos. Studies shows successful fertilization of an oocyte occurs 20mins after the~     gametes are put together. Sperm can penetrate through the cumulus cells within 15min, and~     80% of oocytes can be fertilized when they are exposed to a large number of spermatozoa~     within 1hr. As an attempt to avoid possible detrimental effects on the oocytes from long~     exposure to sperm, the brief incubation insemination protocol was developed. It implies that~     prolonged incubation of oocytes and sperm may not be necessary and may even be harmful. Some~     reports suggest that a sperm-oocyte exposure time of 1-6 h improves IVF outcomes. However,~     other studies report no such advantage with a short insemination time .~      A recent meta-analysis shows brief incubation of gametes was associated with significantly~     higher rates of clinical pregnancy , ongoing pregnancy and higher rate of implantation than~     standard incubation. But the rates of normal fertilization, good quality embryos and~     polyspermy were not significantly different compared with standard incubation. In a Cochrane~     meta-analysis, eight RCTs with 733 women were included, and showed similar results. But it~     only reported clinical pregnancy rate and ongoing pregnancy rate which were significantly~     higher in brief incubation group than standard incubation. However, the live birth rate,~     which is the important outcome parameter, was not reported in all these studies. It is~     uncertain whether brief incubation improves the life birth rate compared with standard~     incubation.~      The aim of this randomized double blinded study is to compare the live birth rate of IVF~     treatment following brief incubation of oocytes and sperm versus standard incubation. The~     hypothesis is that a brief incubation improves the live birth rate of IVF treatment.~   "
39890|NCT02534844|"~     This study evaluates the efficacy and safety of 2-hydroxypropyl-β-cyclodextrin (VTS-270) in~     patients with neurologic manifestations of Niemann-Pick Type C1 (NPC1) Disease.~     Approximately two-thirds of patients will receive the study drug,~     2-hydroxypropyl-β-cyclodextrin (HP-β-CD), while the remaining study participants will~     receive sham control.~   "
39923|NCT02534415|"~     Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on~     secondary wound healing of the free gingival graft donor site. The hypothesis of this study~     is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free~     gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.~   "
39891|NCT02534831|"~     Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease~     characterized by progressive airflow limitation that is associated with an inflammatory~     response to noxious particles or gases.~      Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to~     provide treatment to the musculoskeletal and/or visceral systems. It includes techniques~     such as massage, myofascial release, muscle energy technique, ligament balance, joint~     mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits~     to people with COPD was first put forward in 2009. Since then a number of small studies have~     reported medium term improvements in lung function and exercise capacity following repeated~     applications of MT intervention.~      Our aim is to measure the immediate effect on lung function of a single application of soft~     tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary~     disease.~   "
39892|NCT02534818|"~     The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive~     the same detection rate per patient and per lesion for the detection of gastric intestinal~     metaplasia.~   "
39893|NCT02534805|"~     To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients~     using a patient and caregiver perspective.~   "
39894|NCT02534792|"~     Aim With this retrospective study, the investigators would like to evaluate and, if possible~     confirm, whether earlier revalvulation of the right ventricular outflow tract is better than~     late revalvulation. Up to now, no analysis is done to validate this policy change.~      Patient selection All patients registered in the database of paediatric and congenital~     cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who~     underwent transannular patching at repair will be included in the study.~      Methodology and statistical analysis All files will be reviewed for demographic,~     electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics,~     Cox regression will be performed to detect whether the time period between repair and~     revalvulation influences clinical outcome (defined as death, heart failure hospitalization,~     redo-revalvulation, implantation of automatic defibrillator, endocarditis).~   "
39895|NCT02534779|"~     This open-label study will examine the disintegration/disappearance time, safety, and~     acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert~     twice: first for an in-clinic disintegration/safety assessment, and a second time for an~     at-home acceptability assessment, with safety assessed at the following clinic visit.~   "
39896|NCT02534766|"~     MISSION is a new and novel way of delivering highly specialised Chronic Obstructive~     Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the~     UK is delivered as well as services for other long term health conditions. The MISSION model~     has been piloted in asthma which is the subject of an ongoing research study. This is the~     first model of this type in COPD and the current research study aims to evaluate the~     outcomes of the project. This will be done in several different ways. The study is a mixed~     methods evaluation of the new service comparing outcomes before and after the clinic using~     retrospective data analysis and prospective qualitative interview. The study will be~     conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION~     COPD clinics as well as staff who attended MISSION clinics in a professional capacity.~   "
39897|NCT02534753|"~     This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous~     Ascorbic Acid.~   "
39898|NCT02534740|"~     This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of~     tafamidis will be compared. Subjects will be fasted for each test and every subject will~     test all 3 different formulations. After swallowing tafamidis, tafamidis blood~     concentrations will be measured periodically for 6 days. After 14 days, subjects will take a~     different formulation of tafamidis and tafamidis blood concentrations will be measured~     periodically for 6 days. After another 14 days, the last formulation will be tested in the~     same way. In part 2 of the study, depending on the results of part 1, either none, one or 2~     of the formulations tested in part 1 will be tested comparing the same formulation when~     given either with or without food. Additionally, depending on the results of part 1 of the~     study, different doses of the formulations may be compared.~   "
39899|NCT02534727|"~     Background:~      Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM)~     infections. Sometimes medicine that treats these infections does not get to where the~     bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is~     getting to where it is needed in the lungs. They will look at how much medicine is in your~     sputum (what you cough up) compared to how much is in your blood. They will also investigate~     a new test to quickly figure out what medicines are likely to treat TB effectively.~      Objective:~      To determine the relationship between the concentration of TB drugs in plasma and sputum~     over time.~      Eligibility:~      People ages 18 and older who have TB or NTM infection that is suspected to be drug~     resistant. They must be taking TB or NTM medicines.~      Design:~      Participants will be screened with medical history.~      Participants will be in the study for 2 8 days.~      Participants will give 3 or more sputum samples over at least 2 different days. They will~     cough sputum into a cup.~      Participants will have blood drawn 4 times a day on 2 different days.~   "
39900|NCT02534714|"~     The purpose of this study is to determine if there is correlation between Vitamin D~     deficiency and spinal disease/spinal fusion surgery.~   "
39901|NCT02534701|"~     To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter~     on artery recanalization and on clinical outcomes in stroke patients using data from~     clinical routine application (ERASER).~      To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal~     Access Catheter on the final infarct volume as determined by advanced image postprocessing~     methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).~   "
39934|NCT02534272|"~     D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The~     study aim to determine if the carriage of the intestinal parasite D.fragilis is associated~     to changes of gut microbiota in subjects presenting with or without intestinal symptoms.~   "
39935|NCT02534259|"~     The objective of this study is to develop methods for using forces measured on circular~     external fixators to predict the state of individual patient's healing of severe tibial~     fractures and defects.~   "
39902|NCT02534688|"~     randomized controlled trial~      Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea~     Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule~     Cul-de-sac nodularity Endometrioma detected by ultrasonography size < 4 cm~      Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS >50~     Previous sexual intercourse~      Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal~     use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA~     and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year~      Primary objective To compare efficacy of pain control in endometriosis associated pelvic~     pain between LNG-IUS and DMPA~      Secondary objective To compare side effect, continuation rate, satisfaction and quality of~     life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain~      Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most~     pain~      Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid~     profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by~     linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3~     satisfied 4 very satisfied Continuation rate Endometrioma size reduction~   "
39903|NCT02534675|"~     The purpose of this study is to learn more about personalized cancer therapy including~     response to treatment and side effects. Information from the patient's medical record~     regarding the tests and treatments they have received, or will receive, for their cancer~     will be collected. Genomic testing on tissue from the primary tumor or metastases will be~     used to match therapy recommendations. Patients in which there is no appropriate matched~     therapy will receive systemic chemotherapy according to their treating physician's~     discretion. This information will be used to describe whether or not patients respond better~     when their physicians choose to treat them according to the genetic makeup of their tumor.~   "
39904|NCT02534662|"~     Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty~     (EVG) using an endoluminal-suturing device.~      Briefly, Vertical gastric plication is a novel surgical approach for reducing the stomach~     capacity. Anterior surface plication and greater curvature plication are variations of~     vertical gastric plication that reduce the gastric capacity through infolding of the~     anterior surface or greater curvature of the stomach, respectively. These approaches have~     been tested, with positive results.~      A transoral or endoluminal approach (ie, a procedure that requires no incision, because~     access is granted through the mouth) offers the potential for additional benefit to the~     patient, because the procedures continue to become more and more minimally invasive.~      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring~     bariatric procedures performed via flexible endoscopy. Although these procedures may not be~     as effective as their surgical counterparts, these less-invasive options may relieve~     patients of the significant risks associated with surgery.~      Study duration and number of subjects A period of approximately 6 months is anticipated form~     the time the time the first patient is enrolled to the completion of the last patient.~      The participants will be followed as follow:~      Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects~     observed)~      1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical~     assessment 6 month: Final assessment (Endoscopically and Clinical) On Parallel a nutritional~     specialist will monitor the patient on quarterly basis (1,3,6,12).~      Study procedures The intervention will be performed under general anesthesia with tracheal~     intubation. Endomina will be introduced into the stomach over guide wires and then fixed to~     the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior~     sutures after argon plasma coagulation of the tissue opposition areas in order to ensure~     persistence of the pouch reduction. Patient will be kept overnight after the procedure.~   "
39905|NCT02534649|"~     This is a biology driven, monocentric study designed to identify actionable molecular~     alterations in cancer patients with advanced disease.~      In this trial, high throughput analysis will be carried out using next generation~     sequencing, and immunological profiling.~      Patients included in the BIP study and for whom a targetable genomic alteration had been~     identified might be subsequently included in an early phase trials running at Institut~     Bergonie or another French hospital.~   "
39906|NCT02534636|"~     The purpose of this study is to establish if BMS-986165 is safe and effective at treating~     autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for~     inhibiting autoimmune conditions. This study will be the first time this drug is given to~     humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part~     A will investigate single oral doses of drug. Part B will investigate giving the drug daily~     for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with~     Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in~     a capsule makes a difference to the safety and potential use of this drug.~   "
39907|NCT02534623|"~     Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure~     so high-quality postoperative recovery is particularly important. The aim of this study is~     to compare postoperative quality of recovery after spinal anesthesia (SA) and general~     anesthesia (GA) for transurethral resection of the bladder.~   "
39908|NCT02534610|"~     Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib~     in total knee arthroplasty (TKA).~   "
39909|NCT02534597|"~     This evaluation seeks to assess the impact of a training program on childcare center~     environments and child/caregiver wellbeing in El Salvador. Through a longitudinal,~     randomized control trial, over 200 childcare centers participating in the program will be~     assigned to various treatment arms receiving different components of the program. A~     community comparison cohort will also be enrolled.~   "
39910|NCT02534584|"~     This study is a service evaluation to assess the impact of compliance of Acute Kidney Injury~     care bundle (AKI-CB) on clinical and renal outcomes. The AKI care bundle is coupled with an~     interruptive electronic alert, which is triggered by the first attempt to order blood tests~     or medications on patients who have been identified as having AKI by the electronic~     recognition from serum creatinine results. The interruptive alert will warn the clinician~     about AKI and request them to complete the AKI care bundle. Once the AKI care bundle is~     completed, the clinician is able to request blood tests or medication. The clinician will be~     able to override the alert only after stating the reason. Education with respect to~     importance of AKI and the AKI-CB is provided every four months when junior doctors rotated~     through different specialities and also at clinical governance days. The investigators will~     compare AKI episodes, which have the AKI-CB completed early (defined as within 24 hours of~     availability of the blood results) with those who either had the AKI-CB completed late~     (defined as after 24 hours of availability of the blood results) or not completed at all.~     The AKI patients who either had the AKI-CB completed late or not completed will be~     considered as not having the AKI-CB completed for this analysis.~   "
39936|NCT02534246|"~     The aim of this study is to evaluate and compare the diagnostic accuracy and specimen~     adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy~     regimens, with respect to diagnosis of solid pancreatic lesions.~   "
39911|NCT02534571|"~     Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers~     and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic~     treatment stops active bleeding, reduces rate of further bleeding and leads to improved~     patients outcomes. Endoscopic treatment can be technically demanding especially with lesions~     in difficult anatomic positions and to endoscopists with less experience. TC-325 is a~     propriety mineral blend hemostatic powder used to compress external civilian and military~     traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20~     patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop~     bleeding in 19 of them. Subsequent case series from others reported a similar rate in the~     acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a~     comparison to the current standard in endoscopic treatment is required. A non-inferiority~     randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to~     current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with~     diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal~     bleeding from non-variceal causes. The non-inferiority primary endpoint is control of~     bleeding over 30 days from randomization. Other outcome endpoints include further~     endoscopic, angiographic or surgical treatments, hospitalization, blood transfusion and~     mortality. Investigators also compare ease of therapy measured by procedure time and a 10 cm~     visual analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple~     and less skill dependent technique. It may prove useful in bleeding from anatomically~     challenging sites of the gastro-duodenal tract.~   "
39912|NCT02534558|"~     The team integrates experimental analyses of clinical and basic medicine and transgenic mice~     models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts~     of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue~     homeostasis that alleviates tissue stiffness and maintains function.~   "
39913|NCT02534545|"~     The primary objective of the study will be to determine whether remote limb ischemic~     conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of~     recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial~     artery.~      After screening period, eligible patients will be randomly allocated into 2 groups. In~     addition, all participants receive an usual clinical therapy.~   "
39914|NCT02534532|"~     Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a~     primary healthcare environment using a smartphone device and iECG application as an~     opportunistic screening tool?~      Objectives:~      Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an~     opportunistic screening program using a smartphone device/application~        1. Define the predictable value of the smartphone device with electrocardiogram (ECG)~          confirmation to detect AF in patients 65 years and older~        2. Correlate screened patients cardiovascular risk profile and those that register cardiac~          rhythm irregularities for a better description of the general characteristics of~          Colombian population~   "
39915|NCT02534519|"~     No health condition(s) are studied. Genetic background of blood groups is studied. U- and~     Stones(a)+ (Caucasian type) are used as proof-of-principle samples. Disease associations~     of all blood group genes investigated are very rare, e.g. < 1 among 1'000 Swiss individuals~     (see table 1), and are not to be expected in the course of this study.~      Genomic DNA of 2 U- samples were both provided as blinded reference material from New York~     and Vienna blood centres, respectively. Both donors are lost for follow up, and although~     there is no documented evidence for refusal of the respective donors to use their material~     in research projects, samples still lack informed consent.~   "
39916|NCT02534506|"~     The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects~     with advanced and/or metastatic malignant tumors.~   "
39917|NCT02534493|"~     A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a~     novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical~     function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).~   "
39918|NCT02534480|"~     NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease~     amyloid buildup by targeting Abeta 42 production.~   "
39919|NCT02534467|"~     An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16~     years assessing effects of Montelukast on moderate to severe atopic dermatitis.~   "
39920|NCT02534454|"~     The purpose of the phase 1 translational pilot study proposed here is to gather preliminary~     data investigating the efficacy of transcranial direct current stimulation (TDCS) and~     cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The~     recent use of TDCS over task relevant regions to alter behavior holds incredible promise for~     use in cognitive retraining intervention protocols. Previous studies of cognitive retraining~     have focused on implicit training techniques. This proposed study will attempt to enhance~     these implicit training techniques through the use of TDCS during implicit retraining in~     order to increase learning of avoidance-related action tendencies towards tobacco. The~     objective of this pilot study is to establish the feasibility and obtain preliminary data on~     the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette~     smoking in individuals with nicotine addiction.~   "
39921|NCT02534441|"~     The primary objectives of this study are to identify positivity rates to three novel~     surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower~     the surface tension of the skin and remove debris) and co-reactivity with other surfactants~     in patients with known surfactant sensitivity on skin patch testing. The investigators~     hypothesize that subjects who previously tested positive to known allergenic surfactants~     (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut~     diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate~     co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate,~     isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch~     testing.~   "
39922|NCT02534428|"~     The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the~     effectiveness of wool clothing, as compared to standard clothing, in reducing the severity~     of childhood atopic dermatitis over two consecutive six-week periods.~   "
39924|NCT02534402|"~     In this study, prednisone dose, day/time administration will be controlled in a stable COPD~     patient population to determine its effect on peripheral whole blood gene expression. This~     data has never been collected in a COPD population using the investigators' chosen platform~     for gene expression (Affymetrix Human Gene 1.1 ST). Conducting this experiment is essential~     for achieving the broader aims of an already existing and related study titled Clinical~     Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management study.~     As part of this existing study, blood is being collected from hospitalized and~     non-hospitalized COPD patients in order to develop a blood-based biomarker test for the~     diagnosis and prediction of acute exacerbation of COPD (AECOPD). The majority of these~     patients were administered prednisone as part of standard care for the treatment of AECOPD.~     As such, the effect of prednisone on gene expression needs to be ruled out.~   "
39925|NCT02534389|"~     Neoadjuvant treatment with radiotherapy (RDT) and chemotherapy (CT) are the treatment of~     choice for rectal adenocarcinomas in stages II and III. This results currently in pathologic~     complete response in 10% to 30% of cases. The immune and inflammatory response is altered in~     these individuals and is directly related to response to therapy. Both the disease and the~     treatment of colorectal cancer have an impact on quality of life and nutritional status. In~     studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid~     (EPA) and docosahexaenoic (DHA) - derived from fish oil - has been shown to interfere in the~     process of inflammation, cell signaling and gene transcription enhancing the response to~     treatment. Are reported ability to restore the apoptosis of tumor cells, sensitization of~     tumor cells to chemotherapy, production of less pro-inflammatory cytokines and the~     preservation of normal energy and protein metabolism. The aim of this study is to verify if~     the daily consumption of 2.4 g EPA + DHA for adults in neoadjuvant therapy can promote~     changes on inflammatory and immunological markers of host response to tumor and if this~     response is altered by nutritional status. It is expected that supplementation can reflect~     in control of inflammatory and immune response in favor of tumor cell death contributes to~     pathological complete response and that it happens with preservation of nutritional status.~     Subjects will be randomized as to supplementation. All will be assessed in four moments~     during neoadjuvant therapy and immediate postoperative. Results will be presented by~     comparing the intervention group and control group at each moment.~   "
39926|NCT02534376|"~     There is evidence in human studies as well as animal studies that treatments to lower~     cholesterol can reduce the risk of dying from prostate cancer.To decide if~     cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would~     like to lower cholesterol prior to surgery and then measure the growth of prostate cancers~     cells when the prostate has been removed. The investigators will use the combination of two~     drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The~     drug combination is commercially available with a doctor's prescription and sold as~     Vytorin®. It is known that maximal cholesterol-lower effects are seen after 2 weeks of~     treatment with Vytorin®. Therefore, study patients receive at least 2 weeks, but no more~     than 6 weeks of Vytorin® prior to surgery.~   "
39927|NCT02534363|"~     Cognitive enhancement is a primary goal in treating individuals with schizophrenia.~     Cognitive deficits are already present at the first break of the illness, seem to remain~     stable during early phases and noticeably influence daily functioning. Differences among~     antipsychotics in terms of cognitive effectiveness have turned out to be a topic of~     increasing research interest. The initially postulated superior neurocognitive effectiveness~     of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics~     (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the~     differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of~     this study is to investigate the cognitive effects of aripiprazole, quetiapine and~     ziprasidone in first-episode psychosis at 1 year.~   "
39928|NCT02534350|"~     This study will evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV)~     viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.~   "
39929|NCT02534337|"~     The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA)~     (GEMOX) is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging~     progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.~   "
39930|NCT02534324|"~     The current guideline of asymptomatic severe hypertension (ASH) treatment in emergency~     department (ED) recommends through low level of evidence that the patients should not be~     rapidly decreased their BP in ED but instead receive oral antihypertensive treatment and~     close outpatient follow-up is needed. Unfortunately, there was some ambiguity in the time~     point of BP measurement in ED described in the past literature because high BP on ED~     admission may significantly decrease within hours without any medications. The importance of~     pre-ED discharge BP, which can still be critically high, that may affect the follow-up~     outcome has never been investigated. The study aim of this study is to evaluate the~     physicians' treatment strategies as well as immediate clinical outcomes between patients~     with severely- and moderately-elevated pre-discharge BP after management of ASH its in ED~     during the recent recommendation. The secondary outcome is to compare the BP at follow-up in~     these two groups.~   "
39931|NCT02534311|"~     The purpose of this clinical trial is to prospectively evaluate RA activity using the~     assessment of change in DAS28 under local conditions in Slovakia in participants who are~     treated with subcutaneously administered tocilizumab pursuant to the recommendations of the~     Ministry of Health of the Slovak Republic in order to better assess the disease activity and~     impairment of the joint function.~   "
39932|NCT02534298|"~     The objective is to study the relation between the reorganization of the central auditory~     system, and the psychophysical deficits in binaural hearing in subjects with single sided~     deafness.~   "
39933|NCT02534285|"~     The investigators hypothesize that the noise level in the operating theatre influences the~     patients' requirements of anesthetics. Study subject are patients undergoing abdominal~     surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural~     injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the~     inhalational anesthetic desflurane. Desflurane requirements are adjusted using~     neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are~     randomized to receive hearing protections or not.~   "
39937|NCT02534233|"~     Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of~     various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The~     purpose of this study is to assess the safety, feasibility and performance of cryoablation~     system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous~     dysplasia who need ablation therapy for clinical standard care. The new cryoablation~     treatment will be offered as an alternative to standard ablation therapies already in place~     (radiofrequency ablation, carbon dioxide cryotherapy).~   "
39938|NCT02534220|"~     The aim of this study is to evaluate the gingival margin stability with the use of~     oscillating-rotating toothbrushes compared to manual toothbrushes.~   "
39939|NCT02534207|"~     This study will evaluate the relationship between basmisanil plasma concentrations and the~     occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5)~     subunit in healthy Japanese volunteers. Each participant will have two post-screening~     imaging sessions. In the first imaging session, participants will have a baseline Positron~     Emission Tomography (PET) scan. In the second imaging session, participants will receive a~     single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10~     hours post-dose.~   "
39940|NCT02534194|"~     In the UK and worldwide many babies are born without carers knowing their gestation as the~     mothers will not have had good antenatal care. It is possible to estimate gestation but this~     requires a detailed clinical exam. The investigators wish to improve this by using software~     analysis to pick out features of the baby (face and foot) to try and estimate the gestation~     of the baby once it is born. The investigators will also look explore if the software can~     distinguish the normal face or a baby in discomfort.~      Good estimation of gestation can result in more targeted management of the baby. The~     investigators will capture the images of newborn babies, from a variety of gestations, and~     use this dataset to teach the software to estimate gestational age and level of discomfort.~   "
39941|NCT02534181|"~     The purpose of this study is to evaluate whether a nutritional strategy is effective in~     critically ill patients with cancer diagnosed with refeeding syndrome.~   "
39942|NCT02534168|"~     Pain assessment in infants and toddlers is quite challenging since children in these~     populations are nonverbal or preverbal and cannot describe the presence and severity of pain~     that they perceive. Over the last decade, advances in the field have included the~     development of behavioral scoring systems for the assessment of acute pain . However,~     although they have been validated, these commonly used methods of pain assessment are~     largely subjective and rely on a highly trained observer. An objective continuous measure of~     pain would be an important addition to standard behavioral painscores which require nurses~     to monitor the child's behavioral responses.~   "
39943|NCT02534155|"~     The study is comparing MitraClip® to Surgical therapy in high and intermediate risk~     patients, who should be older than 18 years, and shall evaluate safety and efficacy of~     MitraClip® vs. surgery in high or intermediate risk patients. The patients will be~     randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure~     (hospital discharge, 1, 6, 12 months post-procedure).~   "
39944|NCT02534142|"~     Approximately 40% of members with a positive fecal occult blood result do not continue to~     followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural,~     process, carer and patient related causes of undertreatment and suggest appropriate~     organisational interventions. Using both quantitative and qualitative methods, the~     investigators will identify organisational and personal barriers to completion of followup~     of positive FOBT.~   "
39945|NCT02534129|"~     Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying,~     ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing~     whole breast radiation.~   "
39946|NCT02534116|"~     The purpose of this study is to compare outcomes between incisional negative-pressure wound~     vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal~     surgery.~   "
39947|NCT02534103|"~     As considering the close relationship between systolic dysfunction and diastolic~     dysfunction, the EAS index e'/(a' x s') including systolic and diastolic function could be~     expected to predict hemodynamic changes during off-pump coronary artery bypass~     surgery(OPCAB). Exposure of the grafting site during OPCAB needs displacement of the heart,~     resulting in hemodynamic instability.~      Therefore the investigators are going to evaluate EAS index with preoperative Transthoracic~     echocardiography(TTE) and want to know the relationship between preoperative EAS index and~     intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective~     observational study.~   "
39948|NCT02534090|"~     Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been~     estimated that 16%-29% of premature infants admitted to neonatal intensive care units~     (NICUs) develop feeding intolerance at some point during their length of stay. The most~     frequent signs of FI are the presence of abdominal distension, abundant and/or bilious~     gastric residuals and vomiting suggesting an inability of the infant to further tolerate~     enteral nutrition, it increases with decreasing in gestational age (GA) and birth weight~     (BW). FI represents one of the most uncontrollable variables in the early nutritional~     management of these infants, and may lead to suboptimal nutrition, delayed attainment of~     full enteral feeding and prolonged parenteral nutrition supply.~      NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and~     oxygenation. It provides real time insight into the oxygen delivery, presented as regional~     oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly~     measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS~     vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate~     through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS~     provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.~      This technique uses principles of optical spectrophotometry that make use of the fact that~     biological material, including the skull, is relatively transparent in the NIR range.~      Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm~     infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly~     because an increasing in the splanchnic oxygenation.~      Gay et al. performed abdominal NIRS in premature piglets showing association of~     perfusion/oxygen changes with NEC spectrum.~      The investigators would like to evaluate the association between feeding intolerance and~     unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio.~      Innovation:~      FI diagnosis follows a subjective approach, where the clinician is worried in further risk~     of develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower~     the threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are~     subject of stop or slow the progression of feedings, increasing the risk of intestinal villi~     atrophy, and increase the length of parenteral nutrition support, and also the length of~     stay in the NICU settings. If NIRS technology help the clinicians to detect true~     abnormalities objectively as a new monitor assessing adequate feeds progress decreasing~     failure to feed, and therefore diminishing the need for parenteral feeds and further~     complication associated with it.~   "
39949|NCT02534077|"~     To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated~     cholestasis to receive Omegaven for compassionate use situations for which there are no~     satisfactory alternative treatments.~   "
39951|NCT02534051|"~     Clinics will be randomized to the use of the care pathway for obese pregnant women or~     standard care. Women who are (1) up to 20 weeks + 6 days gestation into their pregnancy, (2)~     are carrying one baby (not twins) that is healthy (no life threatening anomalies) and (3)~     have a Body Mass Index ≥ 30 kg/m², will be included. Data will be obtained from the Ministry~     of Health's Antenatal Records, charts, and for those in the intervention group, the care~     path (filled out by the practitioners - the participants' obstetrician, midwife, or family~     doctor). At the end of the study, practitioners will complete a survey, participate in~     structured interviews to understand barriers, facilitators, and motivators of using the care~     path.~      Primary Objective:~      To evaluate the feasibility of implementing and testing a clinical care pathway for obese~     pregnant women in a pilot cluster randomized controlled trial (RCT)~      Secondary Objectives:~      To obtain pilot data on A) process outcomes (steps of the pathway, e.g. what % of obese~     women receive a screen for diabetes) B) clinical outcomes (e.g. what % of obese women~     receive a diagnosis of diabetes), C) provider outcomes (e.g. Is the intervention acceptable,~     feasible & efficient? Barriers & facilitators to use, effectiveness? [Structured~     interviews])~   "
39952|NCT02534038|"~     Treatment of disinhibition syndrome in participants with Neurodegenrative Disorder.~   "
39953|NCT02534025|"~     Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta~     to ameliorate the effect of reperfusion injury in recipients.~   "
39954|NCT02534012|"~     Elderly patients are usually presented with higher risk for developing cardiopulmonary~     complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been~     associated with favorable outcomes in patients undergoing ventral hernia repair. Hence,~     elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic~     technique.~   "
39955|NCT02533999|"~     Given the large numbers of children who undergo tonsillectomy (by the time a child is 15~     years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity,~     and direct and indirect costs associated with absences for child from school or parent from~     work or other responsibilities, it is vitally important to identify surgical techniques~     which will minimize pain and serious negative outcomes. This study aims to compare a new~     surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used~     methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a~     diagnosis of sleep-disordered breathing.~      In this project, the investigator will evaluate intra-operative outcomes including, surgery~     time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption~     of normal diet and activity, analgesic type and use, and frequency of emergent visits over~     14 days following surgery.~      The hypothesis is that there is no difference in outcomes between the traditional~     extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced~     Peak® Surgery System.~      The long-term goal is to minimize pain and risk of bleeding and shorten the time to~     resumption of normal eating and activities in children undergoing tonsillectomy.~   "
39956|NCT02533986|"~     The main objective of this study is to investigate the effect of a 4-weeks intake of berry~     peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The~     berry peel product will be compared with a placebo in a single-blind, cross-over design.~     Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes~     expression, appetite and cognitive performance will be included as a pilot study.~     Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel~     will exhibit both direct and indirect actions in healthy overweight subjects by improvement~     of glucose-associated markers as well as ameliorating inflammation. Moreover, above~     metabolic markers will correlated with improvements in inflammation-related PBMCs genes~     expression, subjective appetite and cognitive performance after long-term consumption of~     berry peel as a source of polyphenols.~   "
39957|NCT02533973|"~     A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel~     (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as~     required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in~     Chinese subjects with scalp psoriasis~   "
39958|NCT02533960|"~     The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an~     investigator-initiated study, is a German multicenter, prospective, observational registry.~     It is performed at about 50 certified stroke-units and supported by an unrestricted grant~     from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime~     is designed to assess the emergency management of acute ischemic and hemorrhagic stroke~     patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke:~     Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no~     anticoagulation.~   "
39959|NCT02533947|"~     Studies suggest that patients with hematological malignancies undergoing allogeneic~     hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and~     long-term cognitive dysfunction. To address this issue, a randomized controlled intervention~     trial on the effect of physical exercise on cognition is conducted. In addition, the impact~     on psychological and physical health outcomes is evaluated. Results may benefit patients who~     suffer from disease- or treatment-associated cognitive change.~   "
39960|NCT02533934|"~     Pilot, open-label study using fixed dose combination of sofosbuvir /ledipasvir to treat~     HIV/HCV coinfected pre or post liver transplant participants~   "
39961|NCT02533921|"~     The purpose of this study is to improve outcomes for persons living with Parkinson's Disease~     (PD) and their family caregivers. The investigators hypothesize that outpatient~     interdisciplinary palliative care will improve patient-centered outcomes for PD patients at~     high-risk for poor outcomes.~   "
39962|NCT02533908|"~     This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined~     with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for~     analgosedation for short and painful procedures in children.~   "
39978|NCT02533700|"~     Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year~     PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin,~     doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't~     demonstrate better response. At present, there is no standardized treatment protocol for~     this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.~   "
39963|NCT02533895|"~     This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced~     paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an~     anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell~     lysates, in order to investigate its safety and feasibility.~      For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue~     sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be~     treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is~     planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.~      Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a~     cohort of matched historic control patients that were treated using standard of care will be~     conducted. It is planned to analyse 42 historic control sarcoma patients that will be~     matched for disease, recurrences, relapses etc.~   "
39964|NCT02533882|"~     This study will examine the effectiveness of two types of group exercise classes on the~     health and functional status in inactive adults age 18-65 with neurological conditions~     including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be~     randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist~     group who will complete a home-based exercise intervention of either Movement to Music or~     Adapted Yoga.~   "
39965|NCT02533869|"~     This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to~     differentiate between uncomplicated and complicated acute appendicitis. Differentiation~     between the two forms of acute appendicitis is important because according to recent studies~     their treatment differs. Complicated forms are still treated operatively, while~     uncomplicated forms can be treated conservatively with antibiotics. In the initial phase of~     the study, several optimized CT protocols will be created with a phantom model. The two best~     performing models will be selected for the second phase of the study, in which patients~     presenting with suspected acute appendicitis will be imaged with the two protocols. All~     patients participating in the study will be treated operatively, primarily with a~     laparoscopic appendectomy. Thus histological confirmation for the diagnosis can be achieved~     and compared with the CT images. The goal of this study is to optimize a well-performing~     low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.~   "
39966|NCT02533856|"~     This is a randomized controlled trial to assess the relative effectiveness of providing~     Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the~     Emergency Department (ED). Patients who are being discharged from the ED and have had a~     previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or~     Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients~     who consent to enrollment will be randomized to discharge by usual care or discharge with~     ETOC as provided by the company BoardRounds.~   "
39967|NCT02533843|"~     Specific Aim: This prospective randomized study aims to compare the impact of three~     different catheter ablation approaches on long-term procedure outcome in terms of arrhythmia~     recurrence in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF)~     patients. The three strategies to be evaluated are 1) ablation at sources guided by FIRMap~     (using RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap +~     conventional pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of~     non-PV triggers and complex fractionated atrial electrograms (CFAE).~   "
39968|NCT02533830|"~     The aim of the present study was to evaluate the effect of chewing gum on the recovery of~     bowel function after cesarean section in women.~   "
39969|NCT02533817|"~     In the UK, people of black West African and Caribbean's tend to have healthier blood~     cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack.~     But rates of heart disease are now rising in young African-American populations with~     diabetes, for the first time exceeding the rate in their white European-American peers. One~     possible culprit is the increasing consumption of fructose which can lead to high blood fat~     levels. Fructose is a natural sugar found in fruits and table sugar but is also used the~     food industry as an ingredient and sweetener. Because fructose intakes are lower in the UK~     than in North America we are studying the effect of fructose intake in UK black West African~     and Caribbean people, to understand if fructose intake is indeed a reason for these ethnic~     differences.~   "
39970|NCT02533804|"~     The Lake Nona Life Project aims to examine the health and wellness of participants over the~     course of multiple years, focusing on the links between health and wellness, longevity,~     quality of life, and human performance.~   "
39971|NCT02533791|"~     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14~     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious~     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only~     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine~     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry~     products which could be stored at 4℃.~      In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe~     and robustly immunogenic. One shot of the high dose vaccine could mount~     glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. The~     investigators intent to evaluate the safety and immunogenicity of a booster dose of the~     recombinant Ebola adenovirus vector vaccine (Ad5-EBOV) in healthy adults after primary~     immunization in this add in study. The investigators expect that the boosting immunization~     with a same vaccine for primary immunization is possible and could confer a longer-lived~     protection when needed.~      The phase I trial has been unblind 28 days after the primary vaccination, but all the~     subjects are still kept blind as well as the laboratory staffs. Therefore, this booster~     vaccination trial will be conduct in single blind.~   "
39972|NCT02533778|"~     A prospective pilot study to evaluate the recanalization and safety of mechanical~     thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal~     between 8 - 24 hours.~   "
39973|NCT02533765|"~     This is open-label, single-arm, two-stage phase II trial of olaparib in patients with~     relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the~     preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the~     safety of Olaparib in patients with cisplatin-refractory GCT.~   "
39980|NCT02533674|"~     Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of~     PM060184 in combination with gemcitabine in selected patients with advanced solid tumors.~      The study objectives are:~      To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected~     patients with advanced solid tumors.~      To characterize the safety profile and feasibility of this combination in this study~     population.~      To characterize the pharmacokinetics of this combination and to detect major drug-drug PK~     interactions.~      To obtain preliminary information on the clinical antitumor activity of this combination.~   "
39981|NCT02533661|"~     Accumulating data on early intervention for preterm infants in Western countries have~     demonstrated short- to medium-term benefits on enhancing child cognitive outcome.~     Furthermore, the cumulative plasticity of dopamine-related genes may interact with~     environmental intervention in influencing a child's behavior. However, rare studies have~     examined the long-term effect of early intervention for preterm infants in Eastern society~     and whether the genetic markers interact with environmental intervention in shaping child~     developmental outcomes. To meet the contemporary concept of family-centered intervention and~     to adapt the findings of our previous studies into program design, we have developed a~     family-centered intervention program (FCIP) for preterm infants with very low birth weight~     (VLBW, birth weight <1,500 g) in Taiwan and employed a multi-centered, randomized controlled~     study design to examine its short-term effects with respect to a usual care program (UCP)~     and its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and~     dyad-focused services that lasted from hospitalization until 12 months; the UCP contained~     child-focused services in hospitalization and phone calls after discharge. This three-year~     multi-centered study is therefore aimed to extend our research to examine the long-term~     effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for~     VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related~     genes moderate intervention effect on child developmental outcome. A total of 270 VLBW~     preterm infants have been enrolled and randomly assigned to the FCIP and UCP, and their~     buccal cells samples have been collected for typing of dopamine-related genes. All infants~     and families will be examined at 3 and 4 years of age for child and parent outcomes. Child~     outcomes will include growth, health, cognition, language, motor function, and behavioral~     measures; parent outcomes will consist of parental stress and quality of life measures. The~     long-term effect of early intervention for preterm infants will provide important~     information to help medical/educational professionals and public policy makers develop and~     assess effective intervention for Taiwanese preterm children who are at risk of~     developmental disorders. Furthermore, the results will help reveal the gene and intervention~     interaction on child developmental outcome.~   "
39982|NCT02533648|"~     Our recent data in mice have demonstrated a key role of xanthine oxidase in~     hyperglycemia-induced by Reactive oxygen species production, and a preventive role of~     allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and~     structure, in skeletal muscle of diabetic mice. The investigators want to initiate a~     clinical trial in order to evaluate the efficacy of allopurinol on the improvement of~     mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle~     of type 2 diabetic patients.~   "
39983|NCT02533635|"~     This is a single-blind, cross-over pilot study to observe the safety and efficacy of~     Ganoderma tea on eczema patients.~   "
39984|NCT02533622|"~     Despite the known complications of immobility for ICU patients, compliance to mobility~     protocols is lacking in many institutions. Significant barriers have been described to~     compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that~     if progressive mobility is performed for acutely ill ICU patients they may have a reduced~     ICU length of stay, reduced overall hospital length of stay, incur lower hospital costs, and~     reduce the rate of some medical complications and increase functionality post ICU discharge.~      The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and~     the Liko Lift can remove some of the barriers associated with progressive mobility~     compliance.~   "
39985|NCT02533609|"~     Acute kidney injury requiring renal replacement therapy is common in critically ill~     patients. The major causes of AKI are severe sepsis and septic shock requiring effective~     antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so~     that renal replacement therapy is applied using continuous techniques. In recent years, the~     efficacy of renal replacement therapies has improved, namely by using regional citrate~     anticoagulation which improves filter lifetime and filter patency. At present, the extent of~     removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients~     has not been investigated thoroughly. Thus, the investigators want to investigate~        1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and~          imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se~        2. whether filter patency during citrate-anticoagulated CVVD remains stable during a~          treatment period of 72 h~   "
39986|NCT02533596|"~     Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal~     of pathophysiological relevant mediators in various diseases. Adipokines have recently been~     found to play an important role in a variety of immunologic diseases. However, in many of~     these disease states cardiac and inflammatory involvement is common and biomarkers are~     routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on~     biomarkers used in the clinical routine has not been investigated. The aim of this study is~     to determine adipokine and cardiac biomarker removal during TPE therapy.~   "
39987|NCT02533583|"~     The investigator assessed the feasibility and reliability of pulse oximetry plus clinical~     observation for detection the lung disease in neonates.~   "
39988|NCT02533570|"~     The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin~     in adults with active systemic lupus erythematosus (SLE).~   "
39989|NCT02533557|"~     The supraclavicular block can provide effective surgical anesthesia of the forearm and hand.~     There have been many different approaches to ultrasound-guided supraclavicular brachial~     plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach,~     cluster approach) or number of needling (single or double injection). Numerous studies~     demonstrates good results (e.g. faster onset time) when using double injections rather than~     single injection. But double injection does not guarantee complete sensory block because~     ulnar nerve tends to be spared by its anatomical location.~   "
39990|NCT02533544|"~     This is an open-label, single arm cohort study to see efficacy and safety of tenofovir~     disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively~     both.~   "
39991|NCT02533531|"~     This study is intended to assess the feasibility and usability of the 1 Lead Patch as a~     whole, on patients outside the hospital, in the out-patient setting.~   "
40008|NCT02533310|"~     The aim of this study is to examine the efficacy of virtual reality exposure therapy as a~     treatment for specific phobia (spiders). A gamified virtual reality simulation of~     one-session therapy (VR-OST) will be compared to the gold-standard treatment in the form of~     traditional one-session phobia treatment (OST) using in-vivo stimuli. This study was powered~     to detect a non-inferiority margin of a 2-point difference between groups.~   "
39992|NCT02533518|"~     Diagnose lung cancer at an early stage is crucial for effective treatment. At these early~     stages, cancer is usually invisible in ambient white light when the endoscopic analysis of~     the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light.~     These widely distributed autofluorescence methods detect early mucosal abnormalities. They~     are very sensitive but not specific to recognize the lung cancer. Thanks to European funding~     (EURIMUS), a new tool with fluorescent UV light has been developed.~      The purpose of this preliminary study is to verify the suitability for specific detection of~     cancerous tissue in Pneumology of this fluorescence method versus histological analysis of~     the tissue.~   "
39993|NCT02533505|"~     A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects~     with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after~     administration of Symbicort pMDI 160/4.5 μg.~   "
39994|NCT02533492|"~     Total knee replacement is now one of the most popular reconstructive procedures for the~     elderly people to regain their functional capacity and life quality. However the reported~     incidence of postoperative infection or surgical site infection after total knee replacement~     has been around 1 to 2 percent. The cost and expenditure for treating periprosthetic~     infection are high and the results are often detrimental to the patients who suffered from~     the complication. To decrease the wound healing complication related to the contamination of~     bacteria, an antibacterial suture was used successfully in some clinical settings and in~     animal experiments. Whether the antibacterial suture material could be used in patients with~     total knee replacement has not been addressed in the past. The investigators therefore~     propose a prospective randomized double-blinded study to investigate the efficacy of an~     antibacterial suture material in total knee replacement. The inclusion criteria are patients~     with degenerative osteoarthritis without previous surgery to the index knee. Patients who~     have inflammatory arthritis such as rheumatoid arthritis, who have neurovascular disease of~     the lower extremities, who have history of liver cirrhosis or under hemodialysis for renal~     failure are excluded. One hundred and two patients will be randomized to study group (51~     knees) and control group (51 knees) in a period of 12 months. All cases will follow the~     standard protocol based on clinical pathway. Antibacterial suture material (Vicryl Plus,~     Ethicon) will be used in the study group and regular suture material (Vicryl, Ethicon) will~     be used in the control group. Preoperatively, the skin condition (digital photo and image~     analysis),laser Doppler study, inflammatory markers (CRP/ESR/IL-6), functional score (KSS:~     Knee Society Score; SF-12: Short Form 12), and VAS score will be assessed. Operative data of~     operation time, blood loss and wound classification are recorded. Postoperatively, the skin~     condition (digital photo and image analysis), skin temperature, inflammatory markers, KSS,~     and VAS will be assessed on 1st and 3rd postoperative day, 2 weeks, 4 weeks, and 3 months.~   "
39995|NCT02533479|"~     The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles~     in adult healthy human after caloric restriction and acute exercise in order to validate~     erythrocyte FAs profile as marker of changes in muscle fatty acid composition.~   "
39996|NCT02533466|"~     This exploratory study is designed to help develop a clinical model to measure the earlier~     stages of dietary acid medicated enamel loss. The study will use fluoride as positive~     control to explore the validity of this design.~   "
39997|NCT02533453|"~     As current study is conducted to provide additional information regarding safety and~     efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population~     open label, non-comparative, multi-centre design is used.~   "
39998|NCT02533440|"~     This study is researching managing postsurgical pain by injecting both short-acting local~     anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or~     eliminate the need for postsurgical opioids and improve clinical outcomes following the FAST~     dental implant surgery procedure. This approach is being compared to the current standard of~     care.~   "
39999|NCT02533427|"~     This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed-dose~     combination (FDC) + GS-9857 on the pharmacokinetics (PK) of a representative hormonal~     contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and~     will assess the effect of norgestimate/ethinyl estradiol on the PK of~     SOF/VEL/GS-9857+GS-9857.~   "
40000|NCT02533414|"~     In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during~     retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the~     kidney functions by measuring blood and urine Cystatin C and Netrin-1 levels.~   "
40001|NCT02533401|"~     This study will evaluate the efficacy and safety of rituximab in combination with~     chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.~   "
40002|NCT02533388|"~     Elderly patients have an increased risk of stress responses during extubation after general~     anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses~     during extubation after general anaesthesia remains challenging for the anaesthesiologist.~     In this study, we aimed to investigate whether transcutaneous electrical acupoint~     stimulation (TEAS) might decrease the stress responses and improve the quality of recovery~     in the elderly patients who underwent elective supratentorial craniotomy under general~     anaesthesia.~   "
40003|NCT02533375|"~     The primary objective is to investigate efficacy, safety and pharmacokinetics of adalimumab~     in Japanese subjects with generalized pustular psoriasis (GPP).~   "
40004|NCT02533362|"~     A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat~     patients with chronic neutropenia.~   "
40005|NCT02533349|"~     Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD)~     (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies~     had several problems including inclusion criteria, randomization methods, and placebo~     medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had~     synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the~     efficacy of prokinetics as an additional medication to proton pump inhibitor by well~     designed randomized double blind case-control study.~   "
40006|NCT02533336|"~     Over one year period in an area with universal coverage of LLIN and ACT provision as the~     first-line treatment of malaria, the investigators intend to evaluate the impact of DL on~     malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of~     moderate to severe anemia, and entomological parameters. Information on the relative~     cost-effectiveness estimates of DL and the community acceptability of DL will also be~     measured.~   "
40007|NCT02533323|"~     This prospective study was conducted to evaluate the efficacy and safety profiles of~     first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed,~     nasal type, extranodal natural killer/T-cell lymphoma.~   "
40009|NCT02533297|"~     The aim of the current study was to develop a criterion in terms of the number of sessions~     required to achieve mastery in DCS based on the learning curve assessment in real clinical~     situation.~   "
40010|NCT02533284|"~     Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic~     cholecystectomy.~   "
40012|NCT02533258|"~     This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern,~     safety and effectiveness in Taiwan real world routine practice. The primary objective of~     this registry is to monitor the dose adjustment of INLYTA® in real world routine practice.~     The secondary objectives include safety profile, objective response rate, and~     progression-free rate in real world routine practice.~   "
40013|NCT02533245|"~     The primary aim is to evaluate the short- and long-term effect of the 'Transplantoux'~     exercise training intervention in solid organ transplant recipients with matched control~     sample of transplant recipients in view of selected Patient Reported Outcomes (PRO), i.e.~     health-related quality-of-life (HRQOL), psychosocial and behavioral variables, using a~     quasi-experimental design.~   "
40014|NCT02533232|"~     This a randomized double-blind placebo controlled trial which aims to determine the~     beneficial effects of minocycline augmentation to clozapine in partial responders to~     Treatment Resistant Schizophrenia (TRS).~   "
40015|NCT02533219|"~     The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide~     improved presurgical planning and distinguish between focal and diffuse forms of HI. The~     investigators will perform descriptive analysis, relying on visual analysis to diagnose and~     localize a focal lesion. Our findings will be compared to surgical histopathology to~     determine sensitivity and specificity or this technique. The investigators will also track~     patient surgical outcomes, specifically whether the patient is surgically cured or still~     requires medical management to control residual hypoglycemia.~   "
40016|NCT02533206|"~     Chronic sinusitis is one of the most common chronic diseases in North America, with over 5%~     of the Canadian population affected by the disease. Until now, treatment with surgery has~     been performed only in the operating room. Recently a smaller surgical procedure that is~     done in the clinic for some patients with chronic sinusitis with polyps has been found to~     result in symptom control that appears to be similar to that which occurs with sinus~     surgery. Performing the smaller clinical procedure has advantages including a shorter~     recovery time for the patient, a much lower cost to the health care system for the~     procedure, and a shorter patient wait time for the procedure to be done in comparison to~     sinus surgery performed in the operating room. To know with greater certainty that the~     procedure performed in the clinic is as good as the operating room sinus surgery, a large~     multiple investigator randomised clinical trial has been designed. However, before carrying~     out that trial, a practice run or internal pilot study of that trial is required to ensure~     that the trial can recruit patients at the rate that is anticipated and that the procedures~     to obtain the measurements being used for the larger study are adequate.~   "
40017|NCT02533193|"~     The purpose of this study is to investigate the clinical value of enhanced recovery after~     surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay~     days comparing with traditional care .~   "
40018|NCT02533180|"~     The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte~     phenotype of immune senescence or exhaustion is different between operationally tolerant and~     non-tolerant liver allograft recipients.~   "
40019|NCT02533167|"~     Early skin to skin contact has beneficial effects and is part of the Healthy Birth~     Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose~     control, and temperature has been demonstrated. It is the standard of care for vaginal~     deliveries but surgery is a barrier in its initation in the operating room. This study is~     evaluating initiating skin to skin contact as soon as feasible in the operating room.~     Informed consent will be obtained from scheduled/non emergent cesarean sections who are of~     EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin~     contact will be initiated after delivery as soon as apgars and newborn assessment has been~     completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and~     the newborn, with the only interruption being upon movement from the OR table to the~     stretcher when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and~     maternal satisfaction utilizing a sliding 100mm VAS assessment tool.~   "
40020|NCT02533154|"~     Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of~     topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial~     spectrum, it has also been shown to induce toxic effects to the ocular surface. Several~     studies have indicated that BAC may also have altering effects on the bacterial flora of the~     conjunctiva.~      Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular~     surface and the tear fluid resulting in tear film instability, inflammation of the ocular~     surface, symptoms of discomfort and visual impairment, there are many different preserved as~     well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of~     DES. Unpublished data from our department shows differences between artificial tears for the~     treatment of DES with and without BAC in bacterial culture.~      Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops~     with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or~     moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study~     will be recruited and treated either with the preservative-free Prosicca sine eyedrops or~     the BAC containing Prosicca eyedrops for one month. Conjunctival samples will be collected~     of one eye of each patient before and after the 1-month treatment period to compare the~     conjunctival bacterial flora of the two treatment groups.~   "
40028|NCT02533050|"~     The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients~     victims of a coronary artery disease (CAD) (myocardial infarction, revascularization).~     Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic~     patients do not complain in their daytime functioning. The objective of this study is to~     explore whether the objective cognitive assessment measures may be a good marker of the~     efficacy of CPAP treatment given to non-sleepy apneic CAD patients.~      Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after~     randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients~     should have a positive impact on cognitive performance, particularly on attention span and~     working memory measured by improvement in the Paced Auditory Serial Addition Test score~     (PASAT score).~   "
40637|NCT02525081|"~     The aim of this study is to explore effects of long term treatment with ACE-inhibitor on the~     small vessel function assessed by coronary flow reserve (CFR) by transthoracic~     echocardiography and flow mediated dilation in normotensive patients with small vessel~     disease (CFR<2.2) and Angina Pectoris but no obstructive coronary artery disease.~   "
40021|NCT02533141|"~     Statins are drugs representing the most commonly prescribed medication for the treatment of~     hypercholesterolemia. In a recently published study, discontinuation of statin therapy in~     patients after acute myocardial infarction was associated with a higher all-cause mortality~     (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence~     suggests that statins also have vasoactive properties by up-regulating endothelial nitric~     oxide synthase (eNOS) with positive effects on endothelial function. Experiments with~     flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on~     endothelial function but also revealed that withdrawal of statin treatment transiently~     worsens endothelial function, independently of serum cholesterol levels.~      Consequently, this placebo controlled Phase IV crossover study wants to assess changes of~     endothelial function in terms of flicker induced vasodilatation before and during statin~     therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be~     treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced~     vasodilatation and retinal oxygen saturation will be measured with the Dynamic Vessel~     Analyzer system by Imedos at baseline, in the 4th week of simvastatin or placebo intake as~     well as 3, 7 and 14 days after the end of intake.~   "
40022|NCT02533128|"~     Major adverse cardiovascular events (MACE) are a leading cause of serious complications and~     death following major noncardiac surgery. The heart biomarkers brain-type natriuretic~     peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk~     of surgery - low values may permit identifying patients at a very low risk of postoperative~     complications, potentially helping to avoid unnecessary tests and delays prior to surgery.~      Recent studies suggest that the manner in which an anesthetic is conducted may have an~     important impact on postoperative outcomes. The combination of low blood pressure (BP) and a~     deep level of anesthesia despite a low dose of anesthetic - also known as a triple low -~     has been linked to increased complications and death following surgery. However, it is~     unclear whether triple lows actually cause postoperative complications or whether they are~     merely an indicator of a sick patient, who is in general more likely to suffer from~     cardiovascular events in the near future. To answer this question, in this study patients~     will be randomly assigned to groups with lower and higher blood pressures, and the~     postoperative rates of major adverse cardiovascular events and of relevant increases in~     hs-TnI (a marker of cardiac injury) compared.~      Another important question is that of the optimal blood pressure target during surgery.~     Currently there are no established methods of tailoring blood pressure management to the~     individual patient. In the study the investigators will perform ambulatory 24h BP~     measurements prior to surgery to measure the patients' average BP during sleep. In the~     analysis of the study data, the investigators will try to determine the relationship of~     preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to~     the patient's own night-time BP) and of anesthetic depth with the occurrence of major~     adverse cardiovascular events after surgery.~   "
40023|NCT02533115|"~     This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with~     secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.~   "
40024|NCT02533102|"~     This study is designed to first evaluate the effect of food on E7050's pharmacokinetic~     parameters following the administration of single 100 mg oral doses of E7050 tablet to each~     normal healthy participant in the study (Part A), and second to characterize E7050~     pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B).~     Part A will be a randomized, single-dose, open-label, three-treatment period crossover~     study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve~     participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under~     fasted conditions. Following review of safety data of the 200 mg dose level, an additional~     12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.~   "
40025|NCT02533089|"~     Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly~     employed strategy to address the global shortage of skilled health workers. Despite~     availability of effective treatment, tuberculosis (TB) remains an important cause of~     mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new~     TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In~     response to the combined high TB burden and severe healthcare worker shortages in these~     settings, outpatient TB care is among the tasks commonly shifted to LHWs.~      LHWs are community members who have received some training but are not healthcare~     professionals. Randomised trials show LHWs improve access to basic health services and TB~     treatment outcomes, however, insufficient training and supervision are recognized barriers~     to their effectiveness.~      The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and~     evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of~     evidence into LHW practice. The investigators will employ a mixed methods design including a~     pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and~     qualitative methods to understand barriers and facilitators to scalability and~     sustainability of the program.~   "
40026|NCT02533076|"~     Cystinosis is a rare autosomal recessive disorder, characterized by the abnormal~     accumulation of cystine in the lysosomes. Cystinosis is mostly caused by mutations in the~     cystinosin gene (CTNS). The major mutation, which is present in almost 50% of the cystinosis~     patients, is a 57-kb deletion. This deletion removes the first 9 exons and a part of exon 10~     of the CTNS gene. Exon 10 of the CTNS gene is a upstream 5' region that encodes for the~     CARKL gene and also for the first two noncoding exons of the transient receptor potential~     channel, vanilloid subfamily member 1 (TRPV1) gene.~      TRPV1 belongs to the transient receptor potential (TRP) superfamily of cation channels.~     TRPV1 is primarily expressed in sensory nerves and is activated by heating (>43°C) and a~     wide range of chemical stimuli. One of these chemical stimuli is capsaicin, the pungent~     ingredient in hot chilli peppers. The effect of binding of the exogenous ligand capsaicin~     with the TRPV1 receptor is well known to provoke the release of a number of bioactive~     substances including calcitonin gene-related peptide (CGRP). These substances, in turn, act~     on target cells in the surrounding tissue such as mast cells, immune cells and vascular~     smooth muscle cells. The resulting response is characterized by redness and warmth~     (secondary to vasodilatation), swelling (secondary to plasma extravasation) and allodynia~     (i.e. hypersensitivity to heat and touch secondary to alterations in the excitability of~     primary sensory neurons).~      The present study wants to test the following hypotheses:~      (i) The DBF response to topical applied capsaicin is decreased in cystinosis patients,~     compared to matched control subjects.~      (ii) The skin sensitivity response after topical applied capsaicin is decreased in~     cystinosis patients, compared to matched control subjects.~      (iii) The temperature sensitivity is decreased in cystinosis patients, compared to matched~     control subjects.~   "
40027|NCT02533063|"~     This proposed prospective study will evaluate whether a novel exercise approach, seated~     vibration therapy, can improve function in the target population of older adults. Therefore,~     the primary aim of this pilot is to examine the effect of vibration therapy on muscle~     function (balance, muscle power and strength) and muscle mass.~   "
40039|NCT02532907|"~     This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC~     Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to~     determine the effect of new DAA therapies on HCV-related responses in the liver and~     peripheral blood.~      The introduction of new DAAs regimens that do not include IFN provides unique and novel~     opportunities to examine whether successful treatment-induced eradication of viral antigen~     results in reconstitution of T cell immunity. serum and liver tissue samples will be~     collected and stored in hopes of improving treatment and outcomes for future patients.~   "
40029|NCT02533037|"~     This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic~     ankle instability (CAI) with an impairment based rehabilitation program. Individuals with~     CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization~     shoes are used clinically and may improve neuromuscular control by increasing lower~     extremity muscle activation, which may improve gait patterns. The investigators' purpose is~     to determine whether a 4-week rehabilitation program that includes ankle destabilization~     shoes (experimental) has beneficial effects on self-reported function and ankle gait~     kinematics compared to traditional rehabilitation without destabilization shoes (control) in~     CAI patients. In addition, the investigators will compare ankle strength and balance between~     CAI patients and healthy individuals with no history of ankle injury prior to the 4-week~     rehabilitation. The investigators hypothesize the experimental group will have greater~     improvement in self-reported function and frontal and sagittal plane kinematics during~     walking compared to the control group. In addition, the investigators hypothesize that~     patients with CAI will have a decrease in ankle strength and balance when compared to~     healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI~     patients will complete baseline self-reported function questionnaires and walking gait~     trials and then be randomized into control and experimental groups. Both groups will~     complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then~     repeat the questionnaires and walking trials.~   "
40030|NCT02533024|"~     This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients~     undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy~     have changes in nerve conduction latency during surgery.~   "
40031|NCT02533011|"~     Present criteria used to define sepsis are non-specific, making it difficult to both~     distinguish sepsis from other diseases and to predict which patients are likely to become~     more severely ill. In standard care, patients at risk of becoming more severely ill are~     neither identified nor indicated for resuscitative efforts until they develop hemodynamic~     insufficiency or organ failure; after progression to severe disease, mortality increases~     significantly. The identification of risk patients can lead to earlier initiation of~     resuscitation therapies and potentially lead to reduced morbidity and mortality. This study~     aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils~     during infection and a mediator of vascular leakage, can act as a biomarker for the~     progression to severe sepsis with circulatory failure.~      The objective of this study is to validate the utility of HBP to predict the development of~     delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP~     relative to currently used prognostic biomarkers in sepsis.~   "
40032|NCT02532998|"~     This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics~     of AZD9977 following Single-Dose administration to healthy male subjects~   "
40033|NCT02532985|"~     The study will assess the gastrointestinal tolerability of multiple servings of a novel~     dietary fiber at three different dose levels in generally healthy men and women.~     Double-blind controlled, cross-over clinical trial with negative (no added fiber) and~     positive controls. Multiple servings over 24h, with data collection at 24 and 48h and 1 week~     wash-out between cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI~     higher or equal to 18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient~     and positive control will be delivered in 240 ml beverages.~   "
40034|NCT02532972|"~     This is a research study to determine whether a cochlear implantation (CI) device can~     improve hearing in people who are deaf in one ear (known as single-sided deafness).~   "
40035|NCT02532959|"~     Analysis of exhaled breath samples using a high-speed gas chromatography medical device will~     identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and~     Sepsis.~      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis~     System, which includes high-speed gas chromatography, in the early detection of SIRS and~     Sepsis as compared with current SIRS and Sepsis evaluation methods.~   "
40036|NCT02532946|"~     This is a mixed methods study, incorporating a randomized controlled trial and a qualitative~     provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in~     patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting~     reversible contraception in women seeking induced abortion.~   "
40037|NCT02532933|"~     The overall purpose is to compare the kinematics and mechanics of medialized dome and~     anatomic resurfacing through measurement and simulation, and to correlate these findings~     with patient satisfaction and performance.~      Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs~     using stereo radiography and correlation with patient function as measured by Knee injury~     and Osteoarthritis Outcome score, Knee Society score, and strength.~      Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion~     than the dome implant.~      Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact~     mechanics and loading through the use of subject-specific simulation.~      Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar~     implant, while loading between the patellar and femoral components will be reduced.~   "
40038|NCT02532920|"~     Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is~     increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD~     is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity~     defined by SCORAD(Scoring Atopic Dermatitis) : mild (<25), moderate (25-50) and severe~     (>50). The natural history of AD was mentioned in 3 groups: complete remission, persistent~     and intermittent. Atopic march is the progression of atopic disease that has atopic~     dermatitis as the first manifestation then patients will have allergic rhinitis or asthma in~     the future. The investigators do a retrospective study to understand the natural history of~     AD as well as it associate with atopic march. That might be a predictive factor of AD and~     atopic march~   "
40065|NCT02532569|"~     A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and~     safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj.~     and to conduct an exploratory investigation on vaccine interchangeability in Korean children~     aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis~     Vaccine-GCC® inj.~   "
40859|NCT02522195|"~     This study assessed the meal distribution across the day (energy and macronutrient intake)~     and its relationship to the nutritional status of nursing professionals.~   "
40040|NCT02532894|"~     We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function~     measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon~     either activation or apoptosis from different cell types such as platelets, leucocytes and~     endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in~     the blood with the ability to differentiate to endothelial cells. Endothelial progenitor~     cells are inversely correlated to cardiovascular risk factors.~      As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation~     marker used in asthmatic patients - after inhalation of electronic cigarette vapor.~   "
40041|NCT02532881|"~     The purpose of this study is to determine the effect of an internet-based preparation on the~     outcome expectancy and treatment credibility of rehabilitants concerning inpatient~     psychosomatic rehabilitation. Both study groups receive the usual written information for~     preparation (TAU). The patients of the experimental group have access to various videos on~     the study website until their inpatient rehabilitation begins, the patients of the placebo~     group receive no special treatment. The investigators hypothesize that the experimental~     group gains more positive outcome expectancy and treatment credibility compared to the~     control group.~   "
40042|NCT02532868|"~     The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an~     Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the~     oral formulation will also be assessed. The primary study hypothesis is that administration~     of MK-0457 is sufficiently safe and tolerated to permit further study.~   "
40043|NCT02532855|"~     The purpose of the study is to assess the effect of the addition of sitagliptin to metformin~     with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with~     or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the~     overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after~     24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in~     participants treated with the addition of sitagliptin is non-inferior compared to that in~     participants treated with the addition of dapagliflozin after 24 weeks of treatment.~   "
40044|NCT02532842|"~     The primary objective of this study is to explore hospitalization (number, length and~     reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia~     participants during the first 12 months of treatment with once monthly paliperidone~     palmitate in naturalistic clinical settings.~   "
40045|NCT02532829|"~     The HIPER-1 study is a single centre cross sectional study in which a total of 240~     participants (in different metabolic states and surgical models) will receive an Oral Mixed~     Meal Tolerance Test (OMTT). At baseline and after 30, 60 and 120 minutes the PYY levels,~     GLP-1 levels, glucose and insulin sensitivity will be measured. The primary endpoint of the~     study will be the area under the GLP-1 and Peptide - YY curves and insulin sensitivity~     following the OMTT.~   "
40046|NCT02532816|"~     The purpose of this study is to determine and compare the effect of higher nutrient-dense~     complementary foods and standard nutrient dense complementary foods on the catch-up growth~     and nutritional status of stunting children aged 12-23 months old in Indonesia.~   "
40047|NCT02532803|"~     Early cancers of the rectum can be removed safely through the anus without subjecting~     patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic~     microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence,~     hospital stay and avoiding a stoma that may be associated with pelvic surgery.~      Currently few of the patients eligible for TEMS are offered it for a variety of reasons that~     include uncertainties about the risk of leaving residual tumour and the increased risk of~     subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no~     role for imaging in assessing the malignant polyp. Conversely whilst retrospectively~     reviewing their MRI databank the investigators have found evidence that MRI can accurately~     judge the depth of these early tumours and thereby potentially identify patients for local~     excision.~      The investigators hope to prospectively test their hypothesis that an MRI scan can~     accurately gauge depth of tumour spread in an unselected group of benign and malignant~     tumours measuring between 20mm and 50mm in size.~      The investigators will identify eligible patients awaiting surgery / polypectomy and if they~     consent to this pilot study participants will undergo an MRI to assess their tumour which~     assesses safety at all levels of the rectal wall. The accuracy of MRI can then be~     established by reference to gold standard histopathology. Should MRI prove sensitive and~     specific then the investigators hope to change national guidelines to mandate MRI to~     standardise assessment and thereby increase the appropriate use of TEMS in the UK.~   "
40048|NCT02532790|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of HSPN with mild proteinuria in children.~   "
40049|NCT02532777|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of HSPN in children.~   "
40050|NCT02532764|"~     A randomized, double-blind, placebo-controlled study of single and multiple ascending doses~     of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.~   "
40051|NCT02532751|"~     The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish~     version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery~     using patient-reported outcome measures.~   "
40052|NCT02532738|"~     The investigators' preliminary study indicates that MSC is effective therapy in treating~     IBD. But the standard treatment is still lacking and the effect is not stable in IBD~     patients. This study is to explore the efficacy and standard strategy when using MSC in~     refractory IBD.~   "
40066|NCT02532556|"~     Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle~     contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the~     heart. In immobilised patients, or those with blood vessel problems, the pumping process can~     be helped by machines that either squeeze or shock the muscles of the calf (e.g.~     intermittent pneumatic compression, electrical stimulating devices). Many are licensed for~     medical use, and some are common place in hospitals and outpatient departments.~      Objective: The most efficient way of electrically stimulating the calf muscles has not been~     identified. The investigators aim to investigate this using a matrix of electrical~     parameters, and measuring the outcome with vascular ultrasound of the leg.~   "
40053|NCT02532725|"~     Obesity is associated with many undesirable health effects and disease, and middle age is~     associated with increased risk for disease. Unfortunately, while others have looked at the~     effects of obesity, gender, and middle age, the combined effects of obesity and middle age~     on men's ability to do work in hot industrial environments have not been satisfactorily~     investigated.~      This small study evaluates the heat tolerance of lean and obese middle aged men both while~     exercising and resting and the ways in which each compensate for and dissipate increasing~     environmental heat and heat generated by the body while exercising.~      As obesity is a worldwide public health crisis and as populations in many industrialized~     nations age, it is important to understand the combined effects of obesity and middle age~     for men on their ability to safely work in hot environments. Such information will permit~     establishing and revising of safe work standards and inform public health outreach to the~     target population, itself.~   "
40054|NCT02532712|"~     This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple~     Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and~     pharmacokinetics of single-dose and multiple-dose oral administration of the investigational~     product, EC-18 (study drug) in healthy adult male volunteers.~   "
40055|NCT02532699|"~     This the first report undertaken to assess the effect of supplementation with oral~     gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood~     pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks~     could successfully reduce mean diastolic and systolic BP through the suppression of PRA that~     is linked to downstream suppresion of angiotensin II formation, which further decreases the~     sympathetic outflow that leads to hypertension. In addition to blood pressure lowering~     properties, AC mycelia also has beneficial effect in reducing oxidative stress,~     significantly. No adverse events were noted, suggesting that AC mycelia deserve its~     consideration as a candidate for safe alternative treatment to conventional~     anti-hypertensive medications.~   "
40056|NCT02532686|"~     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative~     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still~     a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA)~     hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino~     acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to~     examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant~     schizophrenia patients in a randomized, double-blind, placebo-controlled trial.~   "
40057|NCT02532673|"~     The purpose of this study is to determine whether HIV patients on Atazanavir who have~     Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.~   "
40058|NCT02532660|"~     Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram +~     Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score~     measured by the Hamilton Scale (HAM-D).~   "
40059|NCT02532647|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open-label arm for~     midazolam, in ASA Grade III and IV patients undergoing a colonoscopy for diagnostic or~     therapeutic reasons.~   "
40060|NCT02532634|"~     The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant~     and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving~     highly emetogenic chemotherapy.~   "
40061|NCT02532621|"~     This study is a prospective multicenter evaluation of the performance of the InterGraft~     System for anastomosis of a hemodialysis graft. The InterGraft System includes an arterial~     InterGraft (AIG) connector and a venous InterGraft (VIG) connector used with a standard~     arterial-venous (AV) graft. The study is intended to demonstrate that the 6 month cumulative~     patency of grafts connected with the InterGraft Connectors is similar to that of grafts~     connected using standard sutured anastomoses. In addition, the study will also include a~     separate cohort of up to 25 subjects in whom the VIG is used for the venous anastomosis,~     together with a standard sutured arterial anastomosis, in situations where the target artery~     is not suitable for use of the AIG.~   "
40062|NCT02532608|"~     In this study the investigators plan to systematically characterise infra-slow EEG~     oscillations during sleep, explore their relationship to the microstructure of sleep, and~     investigate its role in the physiology and pathophysiology of sleep by co-registration of~     Full band EEG with polysomnography during wake and sleep in healthy subjects, after sleep~     deprivation, and in patients with restless legs syndrome/periodic leg movements during sleep~     (RLS/PLMS).~   "
40063|NCT02532595|"~     Conflicting evidence exists regarding the recommendations from the Orthopaedic section of~     the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger~     point dry needling is effective in reducing pain in several body regions, but no published~     (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this~     study is to investigate whether a treatment program performed including TDN, manual therapy~     and exercise will result in a significant improvement in pain, strength and function~     compared to a treatment program including manual therapy and exercise for Achilles~     tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN,~     manual therapy and exercise will demonstrate a significant improvement in pain, strength and~     functional outcomes compared to the group that receives manual therapy and exercise.~   "
40064|NCT02532582|"~     The purpose of this study is to ultimately prevent injuries to nerves during surgical~     procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver)~     patients will receive an arterial line as standard of care. The arterial line helps monitor~     blood pressure along with the compression of important vessels during surgery. In addition,~     research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked~     Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation,~     neuromuscular monitoring can tell doctors if the nerves being studied are working normally~     or if they are at risk for injury. This study will help investigators to understand what~     kind of monitoring is best to prevent nerve injuries during a surgical procedure.~   "
40086|NCT02532283|"~     The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in~     combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to~     adults (aged 18 to <= 64 years) with influenza A infection.~   "
40067|NCT02532543|"~     This study is intended to provide statistically robust evidence that Symbios Demineralized~     Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with~     Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during~     ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the~     overlying soft tissues. Additionally, a comparison between each material will be made,~     providing further evidence of each materials' ability to preserve the alveolus. It is~     intended to define in objective terms the response of the hard and soft tissues to ridge~     augmentation.~   "
40068|NCT02532530|"~     Delirium is an acute brain syndrome characterized by a disturbance in consciousness~     accompanied by periods of inattention and changes in cognition. Memory impairment,~     irrelevant speech and disorientation are commonly observed signs and symptoms. Episodes of~     delirium have been associated with a prolonged hospital stay, functional and cognitive~     dysfunction and even an increased mortality. Delirium is a common complication in the~     postoperative setting where the incidence increases with the risk of surgery. The estimated~     incidence of postoperative delirium after cardiovascular surgery is remarkable, ranging from~     31% up to 51%. Diverse preoperative risk factors have been documented for patients~     undergoing cardiac surgery: age, pre-existing cognitive dysfunction, a history of alcohol~     abuse and the severity of illness at admission.~      An early diagnosis of postoperative delirium is of great importance to prevent long-term~     cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should~     be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS)~     provides information on brain oxygenation by quantifying the regional cerebral oxygen~     saturation (SctO2) at the microvascular level. Recently, two studies showed that~     preoperative cerebral tissue oxygenation was lower in the cohort of patients that developed~     delirium postoperatively. Nevertheless, these studies did not investigate whether the onset~     of postoperative delirium coincided with a change of postoperative SctO2. A relationship~     between delirium and reduced cerebral blood flow has already been suggested. As such, the~     occurrence of a postoperative decrease of SctO2 might have been overlooked thus far. Hence,~     Investigators want to conduct a prospective, interventional study to determine the~     relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.~   "
40069|NCT02532504|"~     The aim of this study is to deliver CBT based intervention called Change your life with 7~     Sheets of paper to women with mild to moderate postnatal depression (PND) through trained~     traditional birth attendants (TBAs). Participants will be recruited from low income area in~     Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers~     having children between birth till 12 months. Group intervention will be delivered through~     trained TBAs.~   "
40070|NCT02532491|"~     This study compares the efficacy and effectiveness of two of the second-generation~     antipsychotics (SGAs) most used in our society in the treatment of schizophrenia~     (Aripiprazole and Risperidone) and the investigators do within an assistance program of~     early-stage psychosis individuals of the Community of Cantabria, clinical reference for the~     treatment of this disease in the Spanish Autonomous Community. Patients are included in a~     prospective naturalistic study, open flexible-doses and randomized into one of two possible~     patterns of treatment that includes the protocol.~   "
40071|NCT02532478|"~     The risk factors for stoma reversal failure have been rarely studied, which is probably one~     of the worst scenarios for a case who has a sphincter preserving procedure for a rectal~     cancer and is expecting to have regular bowel movements through a functional anus. Several~     studies have analyzed this particular issue and some have shown that up to 30% of~     'temporary' stomas have never been closed. However these data have been criticized to be~     heterogeneous, since they have included patients with benign and malignant diseases, cases~     underwent elective or emergent anterior or low anterior resections or restorative~     proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some~     subjects. In addition, some studies have underlined some risk factors for the failure of~     stoma reversal, but they also have similar limitations as mentioned above. Finally, survival~     -to the best of investigators' knowledge- has never been separately studied in patients who~     cannot receive a stoma reversal procedure. Thus, current study aims to present a~     single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors~     adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior~     resection for rectal cancer, and accordingly to expose the fortune of these cases.~   "
40072|NCT02532465|"~     Endotracheal intubation is the gold standard for securing the airway. However, while~     managing patients with difficult airways, various supraglottic devices have been used as~     rescue airway devices. The aim of this study is to compare the fiberoptic view through the~     internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the~     fiberoptic view through these two devices, the investigators will determine which device~     provides a clearer passage to the glottic opening and is therefore the preferred conduit to~     aid endotracheal intubation in difficult airways.~   "
40073|NCT02532452|"~     The purpose of this study is to demonstrate that viral specific T-cells (a type of white~     blood cell) can be generated from an unrelated donor and given safely to patients with viral~     infections.~   "
40074|NCT02532439|"~     Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some~     factors of fracture occurrence have been highlighted. For example, some diseases or therapy~     are known to increased risk of bone fracture only in some patients. Accordingly, it is~     important for clinicians to identify patients at risk for bone fracture. Right now, various~     tools are available for the clinicians:~        -  clinical exam,~        -  bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),~        -  an algorithm based on interrogation, clinical exam and bone mineral density. However,~          prediction of bone fracture risk needs to be improved since only 50% of bone fractures~          can be predicted. DEXA provides information for fracture risk estimation, but it is~          unable to distinguish cortical part to trabecular part. It also fails to quantify the~          microstructural properties that influence bone strength. Bone microarchitecture,~          including the cortical compartment can now be assessed in vivo by the HR-pQCT. This~          technique allows access to several parameters: on the one hand the volumetric bone~          mineral density for the whole area measured as well as cortical and trabecular regions,~          and on the other hand, the thickness and cortical porosity and the number of~          trabecular, their orientation and distribution.~      Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on~     cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess~     cortical and trabecular bone microarchitecture.~   "
40087|NCT02532270|"~     The purpose of this study is to determine whether continuous non-invasive arterial pressure~     (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the~     outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive~     arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .~   "
40075|NCT02532426|"~     In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary~     Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling~     feature and also an independent determinant of survival. Muscular impairment involves loss~     of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced~     oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study~     is to elucidate the role of hypoxia in loss of muscle OXPHEN.~      Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline~     biopsies for association with the degree of hypoxemia. In addition, expression levels of the~     key OXPHEN regulators will be measured in pre/post exercise biopsies.~   "
40076|NCT02532413|"~     The purpose of this study is to investigate antiviral efficacy of the combination treatment~     with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for~     chronic hepatitis B.~   "
40077|NCT02532400|"~     To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian~     suppression with chemotherapy in premenopausal patients with hormone receptor-positive~     breast cancer.~   "
40078|NCT02532387|"~     Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis~     (DVT) treatment.~   "
40079|NCT02532374|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD,~     i.e., subjective effects) profiles, and the safety and tolerability of the~     nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different~     nicotine levels in smoking healthy subjects in Relation to Nicorette®.~   "
40080|NCT02532361|"~     The objective of this study is to describe the proportion of hysterectomy in patients that~     had undergone sterilization through hysteroscopic device placement and the patients that had~     undergone sterilization through tubal ligation.~   "
40081|NCT02532348|"~     HIV infection is associated with an immune activation and an inflammatory response - despite~     an active antiretroviral therapy - which may lead notably but not exclusively to~     cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead~     of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction.~     Platelets may play a role in the occurrence of the inflammatory state: they contain big~     amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of~     platelets to the inflammatory state associated with HIV infection has been little studied.~     Thus, it has been shown that platelets in HIV patients are able to release interleukin~     (IL)-18. The group has shown with others that the platelet function could be altered during~     HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with~     platelets.~      The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on~     the platelets activation markers.~   "
40082|NCT02532335|"~     OCAPUSH (EudraCT 2014-002313-33) is a double-blind placebo-controlled parallel-arms study of~     the effects of obeticholic acid on farnesoid X receptor expression in jejunum and on gut~     microbiota in morbidly obese patients and healthy volunteers. Obeticholic acid (OCA,~     6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human~     bile acid chenodeoxycholic acid and will be administered orally at a dose of 25 mg/day~     during three weeks to 20 morbidly obese patients awaiting Roux-en-Y gastric bypass and to 20~     healthy volunteers. On the days before the first and after the last dose faeces and blood~     are sampled for the analyses of bile acids and the gut microbiota. On the day after the last~     dose a push-enteroscopy is performed in conscious sedation for biopsy taking in the~     jejunum.These procedures are repeated 6 month after surgery in the morbid obese patients.~     Inclusion criteria are male or female gender, 20-65 years of age and morbid obesity (BMI >35~     kg/m2) eligible for bariatric surgery. Exclusion criteria are liver diseases other that~     fatty liver disease, other significant morbidity, medications known to interact with OCA,~     pregnancy, uncertainty about safe and reliable contraception, and problems to understand or~     adhere to the protocol. The primary objectives of this pharmacodynamic trial are the study~     of the effect of OCA on the expression of FXR in the jejunum and small intestinal~     permeability, and on fecal bile acids and gut microbiota. The secondary objectives are the~     study of the effects of OCA on the genome-wide FXR DNA binding sites (cistromics) with the~     global gene expression profile (transcriptomics) in human jejunum.~   "
40083|NCT02532322|"~     Uncontrolled pain after posterior fossa surgery and associated negative side effects of~     conventional opioid therapy causes significant morbidity and mortality in infants and~     children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to~     moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children.~     However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in~     children undergoing posterior fossa surgery. In this prospective, randomized controlled~     trial, the investigators aim to determine whether the addition of IV acetaminophen for 24~     hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical~     procedures of the posterior fossa compared with conventional therapy.~   "
40084|NCT02532309|"~     This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin~     dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese~     patients with Carotid Atherosclerosis.~   "
40085|NCT02532296|"~     Improving hospital-to-home care transitions can produce improvements in patient safety and~     health care outcomes, while decreasing medical costs. Most transitions research has examined~     strategies for older patients. This project, however, focuses on younger, high-risk patients~     within a safety net system. The proposed intervention is based on research that patient~     activation, as measured by the Patient Activation Measure (PAM), is correlated with risk for~     hospital readmission. The intervention seeks to increase PAM scores by employing a~     Transition Coach to coach patients, prior to and for 30-days after discharge, to (1) improve~     self-management skills through goal setting and goal attainment; (2) to enhance patient~     capacity to engage in trusting relationships with the Primary Care Provider (PCP), other~     medical specialists, family members of friends, and the Transition Coach; and (3) to improve~     ability to navigate the medical system.~      The investigators will conduct a randomized trial to determine; (a) if PAM scores can be~     increased in the 30-day after hospital discharge; (b) if increased PAM scores, in this~     setting, are correlated with changes in healthcare utilization patterns; and (c) if the~     intervention presents a viable strategy to change healthcare utilization patterns and reduce~     rehospitalizations.~   "
40089|NCT02532244|"~     The goal of this study is to establish a genetic registry of patients with early-onset motor~     neuron and neuromuscular diseases. The investigators will collect samples from patients with~     a motor neuron or a neuromuscular disorder and their family members. The samples to be~     collected will be obtained using either non-invasive (saliva and buccal swabs) or minimally~     invasive (whole blood) means. The research team will then extract high quality genomic DNA~     from these samples and use it to identify and confirm novel gene mutations and to identify~     genes which regulate the severity of motor neuron/neuromuscular diseases.~   "
40090|NCT02532231|"~     The goal of this clinical research study is to learn if opdivo (nivolumab) can help to~     control Acute Myeloid Leukemia (AML). The safety of nivolumab will also be studied.~   "
40091|NCT02532218|"~     The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to~     placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with~     dyslipidemia.~   "
40092|NCT02532192|"~     The goal of this clinical research study is to find the highest tolerable dose of belinostat~     that can be combined with standard chemotherapy drugs (rituximab, cisplatin, cytarabine, and~     dexamethasone) in patients with relapsed or refractory DLBCL who are eligible for an~     autologous stem cell transplant (a transplant of the patient's own stem cells). The safety~     of the study drug will also be studied.~   "
40093|NCT02532179|"~     This is an open label trial of mouse allergenic extract administered by subcutaneous~     injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:~        -  the safety of this therapy when given by injection~        -  biomarkers of the immune response and~        -  whether the therapy would be effective in treating allergic asthma.~   "
40094|NCT02532166|"~     The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%,~     that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination~     with infection of the skin, the oral with his known premalignant potential in up to 2-3%~     predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is~     also an manifestation of the lining of the esophagus, which can then be associated with~     symptomatic strictures of the esophagus.~      The value of moreover increasingly established endoscopic imaging procedures are~     investigated as well as data of the natural long-term outcome in esophageal lichen planus~     infestation especially in view of malignant transformation.~   "
40095|NCT02532153|"~     Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and~     safe antisuicidal agents for preventing suicide attempts. This leads to the immense~     worldwide individual, financial, and societal burden of suicide—which is projected to rise~     in the coming decades—supporting the need for antisuicidal treatments.~      This treatment gap may be filled through understanding the neurobiology of suicide, which~     can guide the development of targeted antisuicidal treatments. Though some research has~     examined the neurobiology of suicidal ideation in the context of depression—implicating the~     orbital frontal cortex, anterior cingulate cortex, and striatum—the underlying~     pathophysiology and neurobiology of suicidal ideation as a separate construct from~     depression remains largely unknown. Therefore, the investigators propose to study the~     neurocircuitry of suicidal thoughts, regardless of whether or not depression is present.~   "
40096|NCT02532140|"~     • To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of~     WCK 5107 alone and in combination with cefepime in healthy adult human subjects.~   "
40097|NCT02532127|"~     Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide~     applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images~     has resulted in a significant increase in the volume of dental radiology procedures.~     Although CBCT is associated with higher radiation risk to the patient than conventional~     dental X-ray imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as~     defined by the High Level Expert Group (HLEG) with doses ranging from a few microsieverts~     (μSv) to millisieverts (mSv) per examination.~      This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary~     European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name~     DIMITRA (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation~     induced risks), the project focuses on the uncertainties associated with radiation-induced~     health risks at low doses in paediatric dentistry and is a multidisciplinary effort to~     approach the involved risks from different yet interrelated perspectives: radiobiological~     characterisation, dosimetric quantification, epidemiological surveying and image quality &~     dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately~     calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to~     feed the radiobiology team with the appropriate data towards the identification, development~     and validation of biomarkers for radiation induced health effects. Furthermore, it will~     constitute the basis upon setting up a gender and age related epidemiology study. The~     balance between image quality and dose levels will be explored aiming at reducing the risk~     through image quality optimization.~      It is expected that DIMITRA`s outcomes and deliverables can be presented to a wider forum~     via a dissemination meeting, leading to further recommendations and potential future~     adaptations for the use of CBCT in paediatric dentistry.~   "
40098|NCT02532114|"~     This phase I trial studies the side effects and best dose of niclosamide when given together~     with enzalutamide in treating patients with castration resistant prostate cancer that has~     spread from the primary site to other places in the body. Androgens such as testosterone can~     cause the growth of prostate cancer cells. Drugs like enzalutamide block androgens from~     driving tumor growth; however, when androgen receptor splice variants are present, these~     drugs may not be effective. Niclosamide may decrease the amount of androgen receptor splice~     variant present within tumor cells, thus promoting the anti-tumor effects of enzalutamide.~     Giving niclosamide together with enzalutamide may be a better treatment for prostate cancer.~   "
40099|NCT02532101|"~     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression~     in this spontaneous diabetes model. The present study aims to determine the beneficial~     effects of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.~   "
40100|NCT02532088|"~     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression~     in this spontaneous diabetes model. The present study aims to determine the beneficial~     effects of Oil Palm Phenolics in subjects with pre-diabetes.~   "
40101|NCT02532075|"~     The purpose of this study is to investigate the effects of performing a breathing muscle~     warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD).~     The main aim is to see whether performing a breathing muscle warm up can improve distance~     walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.~   "
40638|NCT02525068|"~     A multicentre prospective, randomised, phase II interventional study in mCRPC patients~     previously treated with 1‐2 lines of chemotherapy and at least 12 weeks of abiraterone with~     a safety run‐in and single stage phase II expansion cohort.~   "
40102|NCT02532062|"~     This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination~     with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk~     of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3~     supplementation in this population on markers of inflammation and lung cancer risk. Current~     and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk~     of developing lung cancer and represent the clinical population of interest for this study.~   "
40103|NCT02532049|"~     This is a clinical trial in which healthy volunteers will be administered one or two~     experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA~     Pfs25-IMX313 in a prime-boost regime.~      All vaccines will be administered intramuscularly.~      Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.~      Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.~      Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA~     Pfs25-IMX313 at 1x10^8 pfu eight weeks later.~      Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA~     Pfs25-IMX313 at 2x10^8 pfu eight weeks later.~      The study will assess the safety of the vaccinations, and the immune responses to the~     vaccination. Immune responses are measured by tests on blood samples.~      Healthy volunteers will be recruited in Oxford and Southampton, England.~   "
40104|NCT02532036|"~     TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis~     (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route~     in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.~   "
40105|NCT02532023|"~     The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their~     combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β,~     IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of~     COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.~   "
40106|NCT02532010|"~     The purpose of this study is to see if a medicine called pacritinib is both safe and~     effective as a study intervention for patients with AML in combination with either~     decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat~     acute myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are~     used in treatment of AML. Pacritinib is being tested in clinical trials and has not been~     submitted to the U.S. Food and Drug Administration (FDA) for approval for any indications.~     Pacritinib is a drug that is designed to slow down the growth of leukemic cells.~   "
40107|NCT02531997|"~     The purpose of this study is to determine if hypnotic relaxation therapy is a more effective~     intervention for improving self-image in women who have been diagnosed with breast or~     gynecologic cancer when compared to progressive muscle relaxation therapy.~   "
40108|NCT02531984|"~     Bronchiectasis is characterized by a permanent and abnormal dilatation of a part of the~     bronchial tree. An accumulation of mucus in the respiratory tract ensues, resulting in~     frequent bacterial infections and eventual destruction of the lungs. Clinically, patients~     present with a chronic productive cough and episodes of acute respiratory exacerbations.~     Chronic respiratory failure can follow. Although its prevalence is largely unknown,~     bronchiectasis is considered to be a rare and orphan disease. There are numerous causes for~     this disease: sequelae of respiratory infections, immunodeficiency, genetic diseases like~     cystic fibrosis, primary ciliary dyskinesia….The focus of this study will be on non cystic~     fibrosis bronchiectasis in children.~      Due to a lack of pediatric clinical trials, the management of children with this disease is~     widely based on the management of adults or patients with cystic fibrosis or~     pan-bronchiolitis. The treatment is based on respiratory physiotherapy, prevention of~     infections, administration of inhaled corticosteroids and anti biotherapy for acute~     exacerbations.~      Recently, some studies have demonstrated the efficacy of a family of antibiotics, the~     macrolides, in the treatment of cystic fibrosis or pan-bronchiolitis in children. Indeed,~     taken 3 times a week during a long period of time, the macrolides, and specifically the~     azithromycin have shown some anti-inflammatory and tissue repairing properties, in addition~     to their antimicrobial properties.~      Moreover, several studies conducted in the adult population have shown that the use of~     azithromycin has led to significant reduction in the frequency of respiratory exacerbations~     as well as an improvement in the quality of life.~      The efficacy of azithromycin in these respiratory diseases has led to enlarge its use for~     the long term treatment of bronchiectasis. Yet, this type of treatment has no marketing~     authorization application.~      No studies have been conducted in children, but individual examination of patients with~     bronchiectasis treated with azithromycin suggests an improvement of their symptoms.~      Thus, the use of azithromycin in the treatment of bronchiectasis in children seems to be a~     promising therapy. However, its efficacy needs to be demonstrated by clinical trials led on~     a pediatric population with an adequate number of patients and a strong methodology in order~     to ensure validity and reliability of the results.~      Therefore the investigators decided to conduct a comparative, prospective multicenter~     randomized study in this population.~      This study intends to include 100 patients already treated by azithromycin for at least 6~     months. After inclusion, they will be randomized in two groups of 50 patients each. The~     first group will continue the treatment and the other one will discontinue it.~      The patients will be followed from the inclusion period (M0) until the onset of the first~     exacerbation for a maximum of 6 months (M6), with an intermediate health care visit after 3~     months (M3).~      In case of exacerbation, a health care visit will be scheduled; the patient will receive the~     appropriate treatment and he will be suspended from the study.~      The duration of follow up for each patient is dictated by the occurrence of the first~     respiratory exacerbation, a maximum of 6 months .The total inclusion period is 12 months and~     the total duration of the study is 18 months.~   "
40109|NCT02531971|"~     The study to be performed will utilize already FDA-approved marketed products in healthy~     adults for the purpose to generate data for establishing rate of drug delivery comparisons~     between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and~     Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these~     types of products.~   "
40110|NCT02531958|"~     Recently, the United States Department of Agriculture (USDA) has recommended removal of the~     300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a~     connection between cholesterol intake and increased risk for cardiovascular disease (CVD).~     Previous work has shown that daily intake of eggs actually favorably alters many parameters~     associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in~     eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO~     is thought to increase the risk for CVD. Therefore, the purpose of this study is to~     determine a threshold of daily egg intake at which the risk for CVD is not negatively~     impacted in a young, healthy population.~   "
40111|NCT02531945|"~     The main objective of the study is to investigate the correlation between the measurement of~     the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by~     surface topography.~      The device used in this research to the topography examination is three-dimensional~     morphometry device of AXS Medical society : the BIOMOD L.~   "
40112|NCT02531932|"~     The purpose of this study is to evaluate the safety and effectiveness of carboplatin~     compared to the combination of carboplatin and everolimus for the treatment of advanced~     triple-negative breast cancer (TNBC).~   "
40113|NCT02531919|"~     This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in~     patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may~     inhibit the spread of the tumor to other parts of the body (metastases) and improve~     survival.~   "
40114|NCT02531906|"~     This randomized pilot clinical trial studies the side effects of gabapentin and how well it~     works when given together with methadone hydrochloride and oxycodone hydrochloride in~     improving quality of life in patients with stage II-IV head and neck cancer during~     chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help~     relieve moderate or severe pain caused by head and neck cancer during and after~     chemoradiation therapy.~   "
40125|NCT02531763|"~     BE FIT (Behavioral Economics Framingham Incentive Trial) is a pilot study to test the~     deployment of a social incentive intervention using the Framingham Heart Study (FHS)~     Offspring, Generation 3, and Omni cohorts to increase physical activity (PA). The~     investigators will leverage the strength of FHS by recruiting trios and nuclear families to~     test whether social connectedness increases PA. The investigators will utilize a randomized~     controlled trial design. The investigators will test a social incentive intervention~     strategy using a team-based design in which participants work together to jointly achieve~     their PA goals, and a social connectedness intervention.~   "
40171|NCT02531152|"~     Primary Objective:~      To assess the local and systemic safety and tolerability of ascending repeated topical doses~     of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension~     (OHT) as compared to latanoprost.~      Secondary Objective:~      To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in~     patients with OAG or OHT as compared to latanoprost.~   "
40639|NCT02525055|"~     The investigators conducted an initial safety and characterisation study in healthy adult~     volunteers, utilising a unique clinical quarantine facility in London, UK.~   "
40115|NCT02531893|"~     Background:~      When children have severe irritability and temper outbursts, they can be so cranky or angry~     that it leads to problems at home, in school, and with friends. This is called Disruptive~     Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed~     specifically for children with this problem. Researchers think two forms of therapy,~     Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help~     children with DMDD.~      Objective:~      To test two whether IBT and CBT can decrease severe irritability in children and youth.~      Eligibility:~      Children 8-17 years old with DMDD. Their symptoms must have started before age 10.~      Design:~      Participants will be screened with a review of their symptoms. Parents and participants will~     answer questions.~      Participants can do only one or both of these treatments if they wish. Those who wish to do~     both will start with IBT.~      Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent~     will participate in part of the sessions.~      Participants will talk about what makes them irritable and how it affects them. They may be~     put in situations that might make them annoyed or irritable.~      Participants will rate how intense their irritability is. Parents and participants will~     complete rating scales, questionnaires, and interviews.~      Participants will do practice activities at home.~      Participants doing IBT will have up to 14 sessions over 10 weeks.~      Participants will view 15 faces, one at a time, on a computer. They will choose if the face~     looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will~     complete some sessions at the NIH and some at home.~      Participants and parents answer questions about their progress.~   "
40116|NCT02531880|"~     Background:~      - The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a~     neurological disease that causes seizures. It can affect this barrier. Researchers think a~     contrast agent called mangafodipir might be better able to show areas of the brain that~     epilepsy affects.~      Objective:~      - To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas~     of the brain that epilepsy affects.~      Eligibility:~        -  People ages 18-60 who:~        -  Have epilepsy not controlled by drugs~        -  Are enrolled in protocol 01-N-0139~        -  Healthy volunteers~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Participants will have up to 6 visits in 1 3 months. Those with epilepsy will have an~          inpatient stay lasting 2 10 days. Visits may include:~        -  Video-EEG monitoring for participants with epilepsy (not for healthy volunteers)~        -  An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.~        -  Getting mangafodipir through the IV.~        -  5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the~          brain. Participants lie on a table that slides into a metal cylinder. They are in the~          cylinder for 45 90 minutes, lying still for up to 10 minutes at a time. The scanner~          makes loud knocking sounds. Participants will get earplugs.~        -  A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through~          an IV catheter.~   "
40117|NCT02531867|"~     This is a multicenter study in Japan. Eleven sites which have already participated in the~     investigator-initiated clinical study (Early Access Program) will participate in this~     study.The objective of this study is to gain further information on the safety and efficacy~     of treatment with asfotase alfa.~   "
40118|NCT02531854|"~     -  Open label~        -  Enrollment in the order of confirmation of eligibility and HPV+ tumor status~        -  Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR)~          mutation status, performance status and first-line induction chemotherapy outcome;~        -  Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus~          ADXS11-001 vs. 42 patients receiving pemetrexed alone)~        -  Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy~        -  Control Arm: Pemetrexed only~        -  Positive control: pemetrexed chemotherapy~   "
40119|NCT02531841|"~     In the presently planned multicentre Phase III trial the two therapies will be compared:~     Patients will be randomized after intensified induction treatment with 4 cycles rituximab,~     methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy~     against conventional consolidating therapy with 2 cycles of conventional chemotherapy with~     R-DeVIC (rituximab, dexamethasone, etoposide, ifosfamide, carboplatin).~   "
40120|NCT02531828|"~     The aim of this study is validate the use of biopolymer from sugar cane molasses film~     (POLYSHAFT®) a product developed in Experimental Station research laboratories (UFRPE)~     comparing to polyurethane film, or similar, used as a bandage after surgical correction of~     hypospadias, as well as other procedures. The main objective of the study is to prove the~     hypothesis the POLYSHAFT® presents similar or better outcomes in terms of biocompatibility,~     when compared to the polyurethane film when used as a bandage.~   "
40121|NCT02531815|"~     This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind,~     placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-06741086.~   "
40122|NCT02531802|"~     The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT~     adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.~   "
40123|NCT02531789|"~     Current post-operative monitoring of patient recovery consists measuring two blood markers~     C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to~     respond to the onset of infection. However, monitoring the absolute levels of the proteins~     in the three pathways of the complement cascade should provide a faster and better predictor~     of patient recovery. The investigators propose a pilot trial to measure concentrations of~     Complement Cascade (CC) activation biomarkers in the blood over a time course around~     operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis~     of the differential CC pathway activation should identify the onset of recovery~     complications before clinical symptoms present and potentially identify the causes allowing~     the clinicians to target therapies.~   "
40124|NCT02531776|"~     This study will focus on how different injection needles are perceived by patients. The~     needles differ in design and mechanical properties, and will be tested in people with Type 2~     Diabetes. The measured parameters during and after needle insertion are: penetration force~     through skin (measured with force gauge), pain perception (rated on visual analog scale,~     VAS, on a scale from 0 to 10), and skin blood perfusion at insertion site (measured with~     laser speckle contrast scanner). Furthermore, any skin reactions will be recorded.~   "
40126|NCT02531750|"~     Introduction This study will evaluate the effect on glucose, lipid and bone metabolism~     following conservative orthopaedic procedures in patients who suffered from acute Achilles~     tendon rupture. The sedentary rehabilitation period following these procedures may impact~     negatively upon glucose, lipid and bone metabolic pathways whereas the more physically~     active rehabilitation period instituted 8 weeks after the injury is hypothesized to impose~     positive metabolic effects.~      The study is addition to the on-going clinical trial, Non-operative Treatment of Acute~     Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization,~     ClinicalTrials.gov Identifier: NCT02015364.~      Perspective This study will establish whether the well-known effects on glucose, lipid and~     bone metabolism of a sedentary lifestyle can be observed already following 8 weeks of almost~     total abstain from physical activity in non-diabetic individuals, who suffered an acute~     Achilles tendon rupture. Thereby, we will add knowledge to the previous findings following~     strict bed-rest in healthy individuals on glucose and lipid metabolism and bone turnover. In~     a clinical perspective it is important to examine the extent to which individuals~     deteriorate in various metabolic pathways to better understand the pathophysiology behind~     these defects both in healthy individuals and in patients, who undergo bed rest or an equal~     reduction in physical activity as part of their rehabilitation.~      Study design The present study includes 50 cases, who are examined early following injury (<~     2 weeks) (baseline), 8 weeks (6 - 10 weeks) after injury and 52 weeks (40 - 64 weeks) after~     injury, respectively.~      Oral glucose tolerance test (OGTT) with ingestion of 75 g of glucose during a maximum of 3~     min from baseline (0 min). Plasma for glucose, insulin, C-peptide, NEFA will be drawn.~      The individual will bring in morning spot urine for measurement of suPAR, creatinine,~     albumin and orosomucoid.~      The individual will have drawn blood for measurement of HbA1c, total cholesterol, LDL~     cholesterol, HDL cholesterol, triglyceride, Na, K, creatinine, HgB, CRP, leukocytes, ALAT,~     alkaline phosphatase, Ca++, D vitamin, TSH, albumine and amylase. Also blood for BTM and~     plasma suPAR, IL6, TNFa and hsCRP will be drawn. Finally blood for lipid density profiling~     and lipid particle size will be drawn DXA of hip and lumbar spine including abdominal~     visceral and subcutaneous fat is done on a Hologic Discovery scanner.~   "
40127|NCT02531737|"~     The purpose of this study is to determine whether nintedanib (vargatef®) combined with~     docetaxel are effective in second line of treatment in patients with no squamous non small~     cell lung cancer refractory to first line chemotherapy.~   "
40128|NCT02531724|"~     Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal~     oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to~     improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy~     controls after cardiac surgery.~      In order to investigate the effect of levosimendan in patients with AKI after cardiac~     surgery, the investigators plan a randomized placebo controlled trial. 30 patients will~     receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured~     using infusion clearance technique of para-aminohippuric acid and Chromium~     ethylenediaminetetraacetic acid (Cr-EDTA) respectively.~   "
40129|NCT02531711|"~     The goal of this proposed research is to assess the preliminary efficacy of dietary~     interventions that change dietary fats in improving clinical outcomes related to lumbar~     radicular pain. After a two-week baseline, consented participants are randomized to one of~     two diets. Key foods consistent with the diet are provided for 12 weeks along with extensive~     dietary counseling and support from the study-provided materials. Participants are~     encouraged to follow the assigned diet for another 6 weeks without provision of food.~      Participants complete questionnaires at baseline, randomization, and after 6 weeks, 12~     weeks, and 18 weeks on the diet. They provide blood samples at randomization (2 weeks) and~     after 12 and 18 weeks on the diet.~   "
40130|NCT02531698|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study the immune response elicited by this vaccine when given to healthy young children. The~     study will also look at the safety of the new vaccine as well as how it is tolerated.~   "
40131|NCT02531685|"~     Many infectious pathogens, like ETEC, initiate infection by first interacting with the gut~     mucosal surfaces of their human host. Consequently, vaccination strategies that can better~     stimulate protective mucosal immunity are needed if we are to effectively control the large~     number of intestinal pathogens that cause morbidity and mortality in humans. The LT toxin of~     ETEC is a unique antigen in that it also has inherent mucosal adjuvant properties for~     co-administered antigens. Thus, this protein has the potential to be both a stand-alone~     vaccine as well as a mucosal adjuvant for other co-administered vaccine antigens. The~     primary objective is to assess the safety and tolerability of dmLT vaccine when administered~     in three doses intradermally over a range of dosages in healthy adult subjects.~   "
40132|NCT02531672|"~     The purpose of this study is to use a new imaging drug called 11C-choline that is used with~     a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as~     bone scans, CT or MRI.~   "
40133|NCT02531646|"~     The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital~     Tomosynthesis (DE-DT) application against the commercially available predicate devices.~   "
40134|NCT02531633|"~     Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high~     affinity and specificity for binding to the human IL-6 molecule that may have therapeutic~     benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple~     pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of~     transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological~     effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to~     characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The~     study will be conducted in 2 distinct parts (Part A and Part B) and consists of the~     following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B:~     104-week extension phase with the option to receive open-label sirukumab based on disease~     status and a 16-week follow-up phase if applicable.~      Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of~     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to~     receive one of two doses of sirukumab or placebo, each in addition to a pre-specified~     prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be~     assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part~     B, the 104-week extension phase, designed to investigate the long-term maintenance of~     remission and safety following cessation of sirukumab treatment and to assess long-term~     corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of~     GCA flare during the first 52 weeks of Part B will be eligible to receive open-label~     sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks~     after receiving the last dose of study drug, applicable only for those who are withdrawn~     prematurely from the study or whose open-label sirukumab treatment in Part B completes after~     Week 88.~   "
40135|NCT02531620|"~     This is a pilot study designed to evaluate a programme of rehabilitation for patients~     undergoing elective colorectal resection surgery.~   "
40136|NCT02531607|"~     This is a non-randomized natural history protocol in which patients undergoing surgery or~     endoscopy for suspected/ diagnosed pancreaticobiliary strictures are assigned to a) control~     (chronic pancreatitis, no pancreatic neoplasm, primary sclerosing cholangitis), b)~     non-carcinoma (bile duct stones, papillary stenosis, ), c) carcinoma non-pancreatic~     (ampullary and distal bile duct or cholangiocarcinoma) and d) pancreatic ductal~     adenocarcinoma (pancreatic cancer.~   "
40156|NCT02531347|"~     The purpose of the study is to compare antihypertensive treatment based on either~     conventional blood pressure measurements or telemedical home blood pressure measurements.~      Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood~     pressure, is more cost-effective and provides better quality of life.~   "
40137|NCT02531594|"~     This study will test the efficacy of a cessation intervention for caregivers in a large,~     inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers~     who smoke who present to our Pediatric Emergency Department with their child who has a~     Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening,~     Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control~     (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will~     include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and~     Dependence, motivational interviewing, engaging and personalized materials on the effects of~     smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation~     resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine~     replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control~     program will be used as an attention control in which caregivers will receive instruction on~     healthy lifestyle choices to improve the child's health.~   "
40138|NCT02531581|"~     Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains~     high. If anticoagulation is perfectly codified, the remainder of the initial management has~     been less studied.~      In particular, the conditioning Initial often involves systematic plasma volume of 250 to~     500 cc, by analogy to other situations. But this treatment option is not based on factual~     data. In the right ventricular dysfunction that often accompany severe EP, volume expansion~     may instead be harmful, according to the law of Frank Starling. A retrospective study has~     recently shown a benefit of diuretic therapy in patients hospitalized for severe~     normotensive EP.~      The proposed study is interventional, prospective, multicenter, randomized, require to~     include 60 patients.~      The main objective of the study is the comparison of the troponin normalization period Ic~     (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase~     of a serious normotensive EP, between the 2 groups diuretic and filling Vascular.~      The primary endpoint is the time in hours standardization of troponin Ic.~      The secondary endpoints will be:~        -  the period of normalization of Brain Natriuretic Peptide (BNP)~        -  changes in echocardiographic parameters of right ventricular dysfunction~        -  a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of~          thrombolysis.~   "
40139|NCT02531568|"~     The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin~   "
40140|NCT02531555|"~     Background: Aim of this randomized controlled parallel-designed study was to evaluate the~     effects of diode laser as an adjunct to mechanical periodontal treatment on clinical~     parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed~     following initial periodontal treatment in chronic periodontitis (CP) patients.~      Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were~     included and randomly assigned into 3 groups. Residual pockets were treated either only by~     mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or~     by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI),~     bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival~     recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF~     samples were collected at baseline, 1 and 8 weeks after treatment.~   "
40141|NCT02531542|"~     Elderly people constitute the largest proportion of emergency room patients, representing~     12% of all emergency room admissions. The need for diagnostic tests or therapeutic~     interventions is much greater in this patient population. Cardiovascular diseases and~     symptoms represent 12% of the causes for emergency room admission, and patients suffering~     from cardiovascular disease are those whose emergency room visit lasts longest.~      The diagnostic approach in the emergency room in elderly patients admitted for acute~     dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is~     vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and~     are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed,~     some authors have reported up to 50% of diagnostic errors in elderly patients.~      Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis.~     However, peptides suffer from several limitations, particularly in situations that are often~     encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome,~     pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass~     index. Diagnostic performance deteriorates with increasing age, and there is a significant~     increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly~     patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left~     heart failure.~      Some authors have suggested using lung ultrasound in the initial work-up of acute~     respiratory failure, since some specific profiles are known to be related to the presence of~     interstitial oedema, reflecting impaired left heart function (e.g. presence of B lines).~     These studies were performed in the context of intensive or critical care, but data are~     sparse regarding the application of this approach in the emergency room.~      The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach,~     namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung~     ultrasound combined with isolated measure of transmitral flow, would be superior to that of~     NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to~     the emergency department.~   "
40142|NCT02531529|"~     To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion~     during donor hepatectomy.~   "
40143|NCT02531516|"~     The purpose of this study is to determine if JNJ-56021927 plus gonadotropin releasing~     hormone (GnRH) agonist in participants with high-risk, localized or locally advanced~     prostate cancer receiving primary radiation therapy results in an improvement of~     metastasis-free survival.~   "
40144|NCT02531503|"~     The purpose of this study is to determine the predicting factors for asthma remission in~     children.~   "
40145|NCT02531490|"~     Paradoxical fetal and maternal results of studies have led to inconsistent use of~     antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension~     in the Netherlands. However, none of the studies have taken the individual maternal~     circulatory state or the contemplated blood pressure response into account. Hypertension may~     be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of~     low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not~     restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed~     upon as correctors of the hemodynamic state rather than solely reducers of blood pressure.~     Without taking the maternal hemodynamic profile and condition into account, generic~     antihypertensive treatment can be expected to result in disappointing, inadequate and~     paradoxical results. The investigators hypothesize that in mild to moderate hypertension,~     personalized hemodynamically guided antihypertensive therapy (with target systolic and~     diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension~     and/or preeclampsia compared to no treatment, without the alleged side-effects.~   "
40146|NCT02531477|"~     Intra-Carotid delivery of propofol.~   "
40157|NCT02531334|"~     This study is being conducted to evaluate the efficacy of TA-65, a purified extract of~     Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals~     classified with metabolic syndrome.~   "
40147|NCT02531464|"~     Family caregivers play a crucial role in cancer patients care, as they are their principal~     source of support. It is well recommended to provide them with the resources, information~     and support needed to maintain a good health, and to sustain their caregiving role.~     Recently, oncology centres have implemented systematic distress screening programs, but the~     focus has been limited to cancer patients, with little intervention on family caregivers.~     This study aims to address this gap. It will implement and test the effectiveness of a~     simple intervention integrating primary care and oncology care that transfers into practice~     the main recommendations of governmental authorities and experts to globally improve~     supportive care. The intervention includes systematic distress screening and problems~     assessment of family caregivers at diagnosis, and every two months, privileged contact with~     a nurse away from the patient to address caregivers distress and identified problems, and~     for caregivers experiencing high level of distress, liaison by the study nurse with their~     family physician to transfer information on their identified problems and level of distress~     and to facilitate shared follow-up. This intervention has been pilot-tested with family~     caregivers, health care providers and decision makers involved in lung cancer care, as well~     as with community-based family physicians, to ensure its feasibility and acceptability. This~     study findings may clearly improve patient and caregiver experience of cancer care, and~     reduce the burden of disease.~   "
40148|NCT02531451|"~     In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg~     ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During~     these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions).~     Before and after training, muscle volume is measured by MRI, and muscle strength is assessed~     by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus~     lateralis to study gene and protein expression of markers regulating muscle protein turnover~     and prostaglandin synthesis.~   "
40149|NCT02531438|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.~   "
40150|NCT02531425|"~     Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to~     approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or~     subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of~     local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into~     accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single~     28-day cycle.~   "
40151|NCT02531412|"~     Acute kidney injury frequently affects cancer patients. The main cause of acute kidney~     injury is ischemic damage caused by transient decrease in renal blood flow, followed by~     blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury.~     Several studies, mainly in animal models have tried to establish spironolactone role on~     kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal~     transplant recipients that the administration of spironolactone can prevent oxidative stress~     and is safe. The group of cancer patients with states capable of producing tissue~     hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at~     increased risk of developing acute renal ischemia-reperfusion injury.~      The investigators hypothesis is that spironolactone may be useful in preventing acute renal~     injury when administered during the first six hour of renal ischemia-reperfusion insult.~      The purpose of this study is to determine the utility of spironolactone administered after~     an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer~     patients.~      Investigators propose a pilot study, randomized, double blind, placebo controlled trial,~     approved by the local ethical committee, to compare the efficacy of spironolactone to~     prevent acute kidney injury in patients after major surgery. Investigators will include 12~     patients in spironolactone group (25mg daily for three days) and 12 patients in placebo~     group.~   "
40152|NCT02531399|"~     Neurovascular coupling or functional hyperemia is defined as an essential physiologic~     mechanism in the brain, which is necessary for the local adaption of blood flow to altered~     metabolic demands of the tissue. It has been shown that also in the eye, blood flow is~     considerably coupled to retinal neural activity. The current concept of functional hyperemia~     is that visual stimulation, as flicker light, effectuates increasing neural activity in the~     retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and~     consequently induces dilatation and augmented blood flow in the retinal vasculature. In~     several studies, stimulation with flicker light has been shown to induce an increase of~     blood flow in major retinal arteries and veins as well as an increase of optic nerve head~     blood flow. Up until now, flicker induced changes in blood flow were measured solely in the~     major retinal arteries and veins with systems such as the commercially available dynamic~     vessel analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).~      In the present study, the investigators propose to measure the response of total retinal~     blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain~     Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG)~     in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all~     retinal vessels. For comparative reasons, the investigators will furthermore assess the~     blood flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and~     laser Doppler velocimetry (LDV).~   "
40153|NCT02531386|"~     The objective of this study is the evaluation of system accuracy following ISO 15197:2013~     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood~     glucose monitoring systems intended for self-monitoring of blood glucose by patients are~     stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS~     (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva~     Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care),~     OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and~     Accu-Chek Mobile with three different reagent system lots for each BGMS.~      The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.~   "
40154|NCT02531373|"~     This study is designed to assess the effect of different dose levels of pneumococcal~     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and~     infants.~   "
40155|NCT02531360|"~     The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand~     for imaging Tau.~   "
40217|NCT02530554|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator~   "
40158|NCT02531321|"~     The project is a two-arm prospective cohort and pharmacokinetic study comparing~     levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking~     antiretroviral regimens that include ritonavir to those in women who take regimens known not~     to interact with combined oral contraceptives. In addition, the prevalence of ovulation will~     be measured in each group. Participants will take a combined oral contraceptive containing~     levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo~     twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic~     study. The investigators hypothesize that levonorgestrel levels, as measured by~     area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while~     ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of~     at least 3 ng/mL, will be unchanged.~      This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of~     a combined oral contraceptive containing the progestin levonorgestrel. In addition, no~     previous studies have rigorously assessed ovulation in women taking protease inhibitors and~     combined oral contraceptives. As a result, this study will provide new information~     correlating pharmacokinetic changes with effects on ovulation.~   "
40159|NCT02531308|"~     Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects~     with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)~   "
40160|NCT02531295|"~     The purpose of this study is to determine the safety and bioactivity of an herbal supplement~     called kansui, which contains several active ingredients such as ingenols that may have a~     role in helping clear HIV from the body. Kansui has been used in traditional Chinese~     medicine for centuries to treat various ailments such as for eliminating excess fluid in the~     abdomen or lungs, loosening phlegm from the chest, and relieving constipation. Based on~     preliminary in vitro data from our group, kansui extract powder is a potent activator of HIV~     transpcription in latently infected Jurkat cells. The investigators' hypothesis is that~     kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo~     immunologic response, and at the doses administered, increase HIV transcription in~     latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.~   "
40161|NCT02531282|"~     The study's primary objective is to test the hypothesis that a group-based health promotion~     intervention with patient education and practical exercises delivered at a Healthy Life~     Centre increases patient activation in people living with chronic pain. Due to many people~     living with chronic pain, interventions focusing on self-management and coping are on the~     agenda in primary care. This study will investigate whether a Healthy Life Centre in a~     municipality is a suitable setting for interventions targeting people living with chronic~     pain. Short and long term effect of an intervention developed in a health promotion and~     salutogenic framework will be investigated in a randomized clinical trial.~   "
40162|NCT02531269|"~     Using European data from patients included in the Named Patient Program (NPP) and from the~     early post-marketing authorization period, the present study aims to describe patient~     characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in~     Europe. This will be a retrospective cohort study of patients who received treatment with a~     DCV-based regimen in the following context:~        -  Patients enrolled within the European NPP in one of the following countries Austria,~          Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or~        -  In those countries where DCV is commercially available (ie, Sweden, Germany, United~          Kingdom), patients who received DCV during the early post-marketing authorization~          period~      The results of this study will contribute to a better understanding of effectiveness of~     DCV-based regimens in a population that differs from population in the clinical trials, and~     therefore will provide additional valuable information to inform clinical practice.~      This study intends to estimate primarily the effectiveness of DCV-based regimens as measured~     by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As~     well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end~     of Hepatitis C virus (HCV).~      This study intends also to describe as secondary objectives the characteristics (ie,~     demographic and clinical characteristics and treatment patterns of patients starting a new~     DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based~     regimens as measured by:~        -  On-treatment virological response at post treatment follow-up visit Week 4; and~        -  Virological response at the end of treatment (EOT); and~        -  The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post~          treatment follow-up visit Week 24 (SVR24); and~        -  The occurrence of virological failure (on-treatment and relapse).~      An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the~     overall population treated with DCV.~   "
40163|NCT02531256|"~     Evaluation of LMA Protector~   "
40164|NCT02531243|"~     The purpose of this study is to learn whether a new family therapy using computer games with~     biofeedback might help people at clinical high risk for psychosis and their family members~     learn to experience less stress and have fewer mental health challenges.~   "
40165|NCT02531230|"~     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent~     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis~     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)~     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1,~     P2 & P3)~   "
40166|NCT02531217|"~     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in~     the treatment of adult patients with molecularly defined genetic muscular dystrophies.~   "
40167|NCT02531204|"~     The purpose of this study is to assess the bioequivalence between ASP1585 granules and~     ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules~     under open-label conditions in non-elderly healthy male subjects. In addition, the safety of~     these products is assessed.~   "
40168|NCT02531191|"~     The objective of this study is to evaluate the bioequivalence of a new tablet versus a~     current tablet of ASP015K under fasting conditions after single oral administration in~     healthy male subjects.~   "
40169|NCT02531178|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study~     designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of~     different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be~     administered once every other week (EOW) for a total of 4 doses. Subjects will continue on~     their stable dose of methotrexate weekly throughout participation in the study.~      This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects~     per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2~     subjects will receive placebo. Subjects participating in one dose group will be ineligible~     to participate in another dose group in the study.~   "
40170|NCT02531165|"~     Prospective, randomized, open-label, single-center, investigator-initiated trial, including~     patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary~     percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study~     aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital~     Ticagrelor in patients with STEMI according to two different analgesia protocols using~     Fentanyl or Morphine.~   "
40172|NCT02531139|"~     Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be~     maintained despite marked changes in blood pressure. Vascular surgical patients are often~     elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood~     flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study~     is to assess the effect of blood pressure for preservation of cerebral blood flow during~     anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during~     anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level~     than that used in normal clinical practice.~   "
40173|NCT02531126|"~     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients~     diagnosed with moderate to severe ulcerative colitis.~   "
40174|NCT02531113|"~     The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's~     disease.~   "
40175|NCT02531100|"~     This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation~     for intrabony peri-implantitis defects.~      BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline,~     and is intended for filling and reconstruction of bone defects caused by peri-implantitis.~   "
40176|NCT02531087|"~     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.~     Individuals with osteogenesis imperfecta break bones often and may have other problems,~     including hearing loss, dental problems, pain and difficulty getting around. Before the~     genetic cause of OI was known, OI was classified into four types. Each type was based upon~     the symptoms and severity of OI. In most people with OI, the cause is a change in one of the~     genes that makes a protein called type 1 collagen. Some doctors now classify OI both on how~     severe it is as well as which gene is causing OI. When people classify OI this way, there~     are more than 10 types of OI. The current laboratory testing to determine OI subtype~     involves the collection of blood and/or skin cells.~   "
40177|NCT02531074|"~     This pilot study evaluates the use of a mobile application to improve weight loss in obese~     stroke patients. The investigators hypothesize that acute stroke patients who use the mobile~     application are more likely to achieve a minimum 5% weight reduction during the critical six~     months post-stroke, yielding considerable improvement in stroke risk factors.~   "
40178|NCT02531061|"~     Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in~     rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in~     RA. Today some criteria were already proposed and the last one was proposed in 2011.~      All these criteria integrated only clinical criteria without imaging assessment. In this~     context, ultrasound joint is daily performed without definition of remission. A discrepancy~     exists between clinical remission and persistence of active disease with ultrasound joint~     presence of a Doppler effect indicating inflammation and the risk of progression of joint~     damage. A definition of remission in RA could include erosions regression in subchondral~     bone (at best measured by high resolution peripheral quantitative computed tomography~     (HR-pQCT)).~      The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be~     observed only in the absence of local inflammation measured by Doppler ultrasound in the~     erosion.~      Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of~     clinical improvement and structural damage (progression of radiographic lesions). Recent~     data showed that there could be joint bone rebuilt in case of inflammation suppression.~     HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and~     volume could be reduced with anti-TNF, but with a large interindividual variability. There~     was no correlation between the activity of clinical or ultrasound synovium and evolution of~     erosion HR-pQCT.~   "
40179|NCT02531048|"~     Different neurological damage may alter the pain conduction systems centrally (spinothalamic~     pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal~     stimulation selectively stimulates the pain pathways and generates nociceptive signals~     conveyed to the cortex. Registering these cortical responses constitute the technical laser~     nociceptive evoked potentials. If these tests are routinely used, their interpretation must~     remain cautious especially in the elderly.~   "
40180|NCT02531035|"~     This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus~     placebo in patients with T1D.~   "
40181|NCT02531022|"~     This study will use a randomized, controlled trial to test the effectiveness of a home-based~     physical activity program using wearable devices and financial incentives. All participants~     in will establish a baseline step count during the first two weeks and then proceed to a~     16-week intervention period and 8-week follow-up period.~   "
40182|NCT02531009|"~     The primary objective of the study is to assess the change in systemic sclerosis~     (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants~     with SSc.~   "
40183|NCT02530996|"~     Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by~     activation of immune cells, which results in vascular dysfunction (vasculopathy) and~     subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military.~     On a national level there are 5,766 SSc patients (ICD-9 710.1) presently cared for in the~     Veterans Health Administration (VHA). While there is no cure for SSc, studies of~     therapeutics that can help slow disease progression are valuable to our Veterans. This~     proposal addresses the solicitation for projects with attention to SSc requested by~     President Obama after reviewing potential contamination of water at Camp Lejeune. This~     proposal is a patient-centered outreach for our Veterans with SSc to inform and prevent~     catastrophic endstage vascular abnormalities, including digital ulcers, pulmonary arterial~     hypertension (PAH) and scleroderma renal crisis in SSc. The study proposes a novel~     application of a therapeutic for this disease. A better understanding of the initiating~     insult and natural progression of SSc vasculopathy is needed in order to develop~     therapeutics with a goal of curing/treating the underlying disease. This project has the~     potential to impact not only Veterans with SSc, but also those with vascular abnormalities~     including digital ulcers, PAH, and renal crisis. This proposal represents a potential major~     therapeutic advance for our Veterans with SSc.~   "
40218|NCT02530541|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator~   "
40219|NCT02530528|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator.~   "
40184|NCT02530983|"~     The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a~     consistent evaluation tools for patients undergoing esophagectomy or esophageal~     reconstruction in order to standardize and validate outcome measures. Data will be used to~     establish the validation of the Mayo Clinic Conduit Report Card Questionnaires. Data will~     also lead to the establishment of normal or expected scores for patients undergoing each~     type of esophagectomy procedure~   "
40185|NCT02530970|"~     The objective of the SECURE Study is to actively gather additional information on the use of~     the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.~   "
40186|NCT02530957|"~     Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with~     severe life threatening complications. To decrease these complications, preoxygenation is~     recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation,~     applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC)~     improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic~     oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients~     has never been evaluated. The aim of this study is to determine if HFNC combined to NIV~     could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients~     intubated for hypoxemic acute respiratory failure.~   "
40187|NCT02530944|"~     The goal of this new lupus research study is two-fold: first, to understand the genetic~     associations found between people's DNA and this disease, and second, to apply this~     understanding to drug development efforts with the investigator's partners at Pfizer.~   "
40188|NCT02530931|"~     -  This prospective study aims to better characterize inner ear's perilymphatic structures~          with Magnetic Resonance Imaging using contrast media and delayed injection in patient's~          with Meniere's disease.~        -  MR Perfusion Imaging will be assess in both cochlea as well~        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging~   "
40189|NCT02530918|"~     The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for~     neovascular age-related macular degeneration (AMD). The hypothesis of the study is that~     DS-7080a is safe and shows preliminary efficacy in patients with neovascular AMD either~     alone or in combination with ranibizumab. This study is organized into 2 parts: Part 1 Dose~     Escalation and Part 2 Dose Expansion. In Part 1, subjects will be enrolled into 3~     sequential, ascending dose-level cohorts in non-randomized uncontrolled manner. In Part 2,~     subjects will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or~     monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a~     plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).~   "
40190|NCT02530905|"~     This is a first-in-human dose-titration and open-label extension study to assess safety,~     tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy~     (DMD) patients with deletions amenable to exon 45 skipping.~   "
40191|NCT02530892|"~     The purpose of this study is to determine whether embryo mechanical properties measured~     after in vitro fertilization can predict clinical pregnancy.~   "
40192|NCT02530879|"~     This study will be a prospective, randomized, unblinded but controlled trial. Patients~     presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux~     disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the~     study. Subjects will be randomized to one of three treatment arms, voice therapy,~     anti-reflux therapy, or a combination of voice therapy and anti-reflux therapy. Reflux~     symptom index (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10)~     scores, and consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared~     prior to initiation of therapy as well as at 1, 2, and 3 months following initiation of~     treatment.~   "
40193|NCT02530866|"~     This is a randomized clinical pilot trial designed to assess the feasibility of randomizing~     obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and~     cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and~     duration will also be compared between groups.~   "
40194|NCT02530853|"~     This is a randomized clinical trial with blinded, multi-center, involving the Federal~     University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a~     proponent and research coordinator; and as a collaborative educational institutions, the~     Federal University of in Espirito Santo, represented by the Department of Nursing; and the~     Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by~     building doctorate thesis as a final product of the research.~   "
40195|NCT02530840|"~     In the IMPACT project, the investigators want to improve adherence and commitment to~     treatment.~   "
40196|NCT02530827|"~     Background: Several studies have reported increased resting energy expenditure (REE) in~     people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV~     lipodystrophy syndrome.~      The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in~     resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive~     for HIV in treatment of lipodystrophy.~   "
40197|NCT02530814|"~     In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine~     pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane,~     toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests~     and to improve crop harvests. For most of those years, the farmworkers were exposed to the~     pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these~     organochlorine pesticides (OCPs) are readily taken up into the body and not readily~     eliminated. Therefore, they can be detected in exposed individuals for many years after the~     exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems~     in sensitive individuals. For example, exposure to some OCPs has been associated with~     development of Parkinsonism. Exposure to other OCPs has been associated with development of~     lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are~     endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may~     have mixed interactions with steroid receptors.~      In this research study the investigators aim is to test the blood from former farmworkers~     during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for~     the auto-antibodies. In addition, questionnaires will provide insight on their health status~     and health concerns.~   "
40198|NCT02530801|"~     Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it~     is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by~     causing astigmatism and may encroach on cornea (transparent part of the eye) affecting~     vision. It could cause ocular irritation and can be cosmetically unacceptable especially~     when inflamed.~      Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium~     vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of~     your eye), before advancing on to the cornea. Treating the recurrent pterygium before the~     cornea gets involved avoids repeat surgery, which is difficult and is associated with more~     scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be~     stopped before it progresses to true recurrence.~      Several studies attributed the recurrence pf pterygium to the increase of substances as~     vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF)~     and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF~     and fibroblast growth factor.~      Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring~     pterygium has been both safe and effective in treatment of recurrent pterygium.~      In many cases, vascularization and inflammation were controlled by subconjunctival Avastin,~     providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in~     ophthalmology because of its anti-scarring properties.~      The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a~     challenging condition that usually resists conventional surgery and its rate of recurrence~     after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by~     scarring, more risk of intra and post- complications This study aims to generate data to~     inform further studies towards establishing Avastin and 5 fluouracil as treatment modality~     for recurrent pterygium.~   "
40199|NCT02530788|"~     This planned pilot study is a monocentric, prospective, double-blind randomized and placebo~     controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.~      The aim of the present trial is to provide the scientific rationale for a large multicenter~     clinical trial, investigating the effects of perioperative high dose selenium~     supplementation in high-risk cardiac surgical patients undergoing complicated open heart~     surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The~     investigators hypothesize that the therapeutic strategy tested in this randomized trial may~     contribute to a faster independency from life-sustaining technologies in the ICU and a~     decrease of postoperative morbidity and mortality. Before proceeding to the large-scale,~     definitive trial, the investigators propose to conduct a pilot study of the definitive~     randomized trial, to determine the feasibility of the study protocol.~   "
40200|NCT02530775|"~     The purpose of this study is to determine whether instrumented lumbar fusion provides~     superior clinical outcomes in comparison to non-instrumented fusion in patients with~     static degenerative spondylolisthesis.~   "
40201|NCT02530762|"~     The study will assess the gastrointestinal tolerability of a single serving of a novel~     dietary fiber at three different dose levels in generally healthy men and women.~     Double-blind controlled, cross-over clinical trial with negative (no added fiber) and~     positive controls. Single dose, with 24 hours data collection and 1 week wash-out between~     cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to~     18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive~     control will be delivered in 240 ml beverages.~   "
40202|NCT02530749|"~     Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been~     evaluated. This study aims to determine if frailty predicts neurosurgical complications in~     brain tumor patients and enhances current perioperative risk models.~   "
40203|NCT02530736|"~     This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary~     Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF~     patients changes following pulmonary rehabilitation and if it changes, what is the smallest~     change that is meaningful to patients.~   "
40204|NCT02530723|"~     Extending quality of life and attenuating functional decline is paramount in older adults.~     This study investigates the effects of low-intensity power-training in older women and its~     effects on functional outcomes.~   "
40205|NCT02530710|"~     Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and~     female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1~     - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo)~     in a fasting state.~      Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a~     cohort, completes all procedures and none of the subjects has a clinically significant~     adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related~     serious adverse events (SAEs) have occurred.~      A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100~     mg dose level (this dose level may change based on PK analysis results). Subjects who~     received 100mg dose in a fasting state will return and receive the second dose, with food.~      Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.~   "
40206|NCT02530697|"~     Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries~     worldwide. The standard treatment with meglumine antimoniate has a high rate of important~     adverse effects. This interventional study consists in a randomized clinical trial to access~     efficacy and safety of the association of miltefosine and pentoxifylline compared to~     meglumine antimoniate and pentoxifyline.~   "
40207|NCT02530684|"~     It is critical to improve our understanding of knee osteoarthritis and to design better~     therapeutic options for this disease. The function of the knee during walking is an~     important factor in the development and progression of the disease. Many models of insoles~     that can be inserted in regular shoes with the objectives of improving the function of the~     knee are available on the market without prescription. Prior studies on these insoles failed~     to report clear benefits for the patients, mainly because the results varied strongly~     between persons. Walking is a complex tasks and it is well known that everybody develops~     his/her individual way of walking (ie., there are subtle but very important differences in~     the function of the knee). This observation and the fact that patient responses could vary~     between individuals suggest that using the same standard insoles with all patients might not~     be appropriated. This further suggests that care could be greatly improved if it was~     possible to identify patients that would respond positively to a model of insoles.~     Unfortunately, while several randomized controlled trials were conducted on these insoles~     for knee osteoarthritis, there is a paucity of data regarding their effects on the~     ambulatory function of the knee. Therefore, this study aims to improve the understanding~     regarding the effects of insoles freely available on the market in terms of knee mechanics~     during walking and its relation with quality of life. This study will test the hypotheses~     that (i) insoles have an effect on the static and dynamic lower-limb function and (ii) that~     benefits perceived by the patients are related to the mechanical effects produced by the~     insoles.~   "
40208|NCT02530671|"~     Background: Clinical studies have explored the relationship between toothbrushing and the~     development of recession, but relevant recession data for the multi-directional power~     toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing~     with either a multi-directional power toothbrush (PT) or an ADA (American Dental~     Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession~     (Pre-GR) over 12 months~      Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized~     controlled clinical study. Healthy participants without periodontitis but with at least 2~     teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The~     primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession~     measurements were performed by one calibrated examiner at baseline, 6 and 12 months.~     Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR),~     changes in the percentage of recession sites demonstrating a change of ≥1mm as well as~     changes in pocket probing depths.~   "
40209|NCT02530658|"~     The development of next generation sequencing (NGS) techniques, including whole genome~     (WGS), exome (WES) and RNA sequencing has revolutionized the ability of investigators to~     query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer~     Genome Project (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have~     successfully used NGS approaches to evaluate more than 1,000 pediatric cancers ranging from~     hematologic malignancies to central nervous system (CNS) and non-CNS solid tumors. From~     these and related studies, it has become clear that genomic approaches can accurately~     classify tumors into distinct pathologic and prognostic subtypes and detect alterations in~     cellular pathways that may serve as novel therapeutic targets. Collectively, these studies~     suggest that by characterizing the genomic make-up of individual tumors, investigators will~     be able to develop personalized and potentially more effective cancer treatments and/or~     preventive measures.~      Despite recent advances, NGS approaches are not yet routinely used as part of clinical care~     due to their high cost and technical complexity, as well as the many challenges related to~     data analysis and translation to the clinical setting. The overarching goal of this protocol~     is to establish and test processes by which NGS technologies, including WGS, WES and RNA~     sequencing, can be offered to pediatric oncology patients undergoing treatment at SJCRH.~      This is a non-therapeutic study examining the feasibility, acceptance and impact of clinical~     WGS, WES and RNA sequencing in a pediatric oncology setting. Investigators anticipate a~     sample size of approximately 400 patients and 400-800 biological parents.~   "
40210|NCT02530645|"~     A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness~     of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors~     among homeless young adults) plus a brief motivational intervention (BMI), in comparison to~     treatment as usual (TAU) at Covenant House New York (CHNY) for those with substance abuse~     problems and who engage in risky sex. Following referral, screening, and eligibility~     determination, 60 participants will complete informed consent and be randomly assigned to~     one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at~     baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption,~     marijuana use, HIV sexual risk behaviors, and other relevant variables.~   "
40211|NCT02530632|"~     Effects of different general anesthetics on peripheral microcirculation.~   "
40212|NCT02530619|"~     The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or~     good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug,~     alisertib, is an investigational drug. An investigational drug is one that has not been~     approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the~     lab that it may have an effect on a type of cell that produces platelets. This cell is~     called a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and~     MF.~   "
40213|NCT02530606|"~     This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian~     or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to~     light up tissue, and then converts the light information into ultrasound images.~     Photoacoustic imaging can provide images of the structure of tissues, as well as their~     function and the levels of molecules, such as the flow of blood in blood vessels and the~     level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a~     mass is benign (non-cancerous) or cancerous based on the molecular differences between~     cancer and normal tissue. It may be more accurate and less expensive than other imaging~     methods, and does not expose patients to radiation.~   "
40214|NCT02530593|"~     All patients presenting at participating hospitals during the recruitment period with a~     newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible~     for inclusion. They will answer a questionnaire on health related quality of life, physical~     symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36~     months. Clinical data including recurrence, survival, surgical treatment, oncologic result~     (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal~     Cancer Registry (SCRCR)~   "
40215|NCT02530580|"~     GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain.~     For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium)~     have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement~     disorders. However, the use of these medications is often compromised because of their side~     effects, such as sleepiness, memory problems, and addiction.~      Therefore, effort has been made to develop drugs that act more selectively in the brain to~     exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325~     is one of these drugs. It has been tested in more than 700 people and so far proved to be~     generally well tolerated. Positron emission tomography (PET) study in humans demonstrated~     that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical~     studies have shown that it has less sedative and cognitive adverse events as compared with a~     benzodiazepine lorazepam.~      The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in~     healthy volunteers and to establish which of the drug's outcomes could be utilised for~     further studies in patients with neurological diseases.~      The investigators are especially interested in the effects of AZD7325 on manual dexterity~     and skin sensation of the hand. This can be assessed by a number of simple non-invasive~     tests of object manipulation and detection of different sensory stimuli such as touch,~     vibration, or temperature. Recent studies show that healthy individuals who performed better~     in similar tasks had more GABA in relevant areas of their brain. If performance in these~     tasks in healthy volunteers can be improved by enhancing GABA effects in the brain with~     AZD7325, this would create the grounds for the use of this medication to treat symptoms of~     certain neurological disorders in which motor control and sensation of the hand is impaired~     (e.g., polyneuropathy).~   "
40216|NCT02530567|"~     The objective of this research is to study the correlation between the portosystemic~     pressure gradient and azygos blood flow measured by MRI.~   "
40220|NCT02530515|"~     Patient's immune systems are often damaged by chemotherapy or by CLL. Researchers want to~     learn if giving T-cells (immune cells) that have been expanded and specially processed in~     the laboratory (activated) will help CLL patients' immune systems recover after~     chemotherapy. This may help lower the chance of infections.~      The goal of this clinical research study is to learn if an activated T-cell infusion, when~     given with or without lenalidomide, can help to restore patients' immune systems when given~     after chemotherapy (rituximab and fludarabine with cyclophosphamide or bendamustine). The~     safety of this treatment combination will also be studied.~      Researchers also want to learn if the activated T-cells may also be able to kill cancer~     cells.~   "
40221|NCT02530502|"~     The purpose of phase I trial is to determine the safest, most effective dose of MK-3475~     (pembrolizumab), when used with radiotherapy and temozolomide for treating newly diagnosed~     patients with glioblastoma (GBM). Phase II trial will evaluate if MK-3475 used in~     combination with temozolomide and radiation followed by radiation and temozolomide to see if~     this is better than using radiation and temozolomide alone. Temozolomide binds to the~     deoxyribonucleic acid (DNA), changes it, and triggers the death of tumor cells. MK-3475 is~     an investigational drug, it is not currently approved by the Federal Drug Administration~     (FDA) for use in treating GBM but it is approved for treating melanoma. MK-3475 works by~     targets the local tumor immune-protection in solid tumors. It is hoped the addition of~     MK-3475 to the usual treatment for GBM will improve the current treatment.~   "
40222|NCT02530489|"~     The goal of this clinical research study is to learn if receiving atezolizumab and abraxane~     (nab-paclitaxel) in combination before surgery and atezolizumab alone after surgery can help~     to control breast cancer. The safety of this study drug combination will also be studied.~   "
40223|NCT02530476|"~     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerated dose of~     the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients~     with FLT3-ITD and -D835 mutated AML or FLT3-mutated high-risk MDS.~      The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control~     the disease.~      The safety of the drug combination will also be studied in both parts of this study.~   "
40224|NCT02530463|"~     The goal of this clinical research study is to learn if nivolumab and/or ipilimumab, with or~     without azacitidine, are safe to give to patients with MDS. Researchers also want to learn~     if the study drug combinations can help to control the disease.~   "
40225|NCT02530450|"~     The purpose of this study is to determine if the use of continuous glucose monitoring in a~     practical outpatient clinic setting in children with poorly controlled diabetes will lead to~     improved blood sugar control.~   "
40226|NCT02530437|"~     The goal of Phase 1B of this clinical research study is to find a dose of Taladegib that can~     be given safely with the chemotherapy drugs carboplatin and paclitaxel and radiotherapy to~     patients with esophageal or gastroesophageal junction cancer.~      The goal of Phase 2 of this clinical research study is to learn if Taladegib given with~     chemoradiation can help to control the disease. The safety of this treatment combination~     will continue to be studied.~   "
40227|NCT02530424|"~     This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial~     management of the Fondazione Michelangelo in Italy.~      Women with a diagnosis of invasive unilateral non metastatic HER2-positive and ER-positive~     breast cancer suitable for neoadjuvant therapy.~      Patients in this study will receive: Trastuzumab+Pertuzumab+Palbociclib+Fulvestrant (HPPF)~      Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6~     administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a~     total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for~     a total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4~     weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial~     dose (total administrations including the additional one = 6)~      The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5~     administrations every 4 weeks plus the additional dose given two weeks after the initial~     dose) was selected to match as closely as possible the total duration of the six planned~     3-weekly administrations of trastuzumab and pertuzumab~      Definitive surgery will be performed not earlier than 14 days and not later than 28 days~     after the last dose of any of the drugs in the combination reported above~      After completion of the neoadjuvant and surgical treatment patients will receive irradiation~     as locally acceptable.~      Patients will also continue to receive systemic drug therapy including chemotherapy, and~     standard HER2 treatment until completion of full 1 year and endocrine therapy according to~     local guidelines at the Investigator's discretion.~   "
40228|NCT02530411|"~     A randomised double blind placebo controlled phase II study of fulvestrant with or without~     the addition of vandetanib as treatment for patients with metastatic breast cancer resistant~     to aromatase inhibitor therapy.~   "
40229|NCT02530398|"~     To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on~     digestive system cancer patients with malignant ascites, and propose dosage regimens for~     future clinical trials. The clinical trial is divided into two parts, including single and~     successive administration.~   "
40230|NCT02530385|"~     The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota~     transplantation (FMT) transfers intestinal bacteria by a stool transplant from a healthy,~     lean person to a person with obesity.~   "
40231|NCT02530372|"~     The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine~     collection device for women, in hospitalized patients who would otherwise be treated with an~     indwelling catheter, pads or diapers.~   "
40232|NCT02530359|"~     Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF~     600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and~     placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7~     days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal~     function as a primary objective.~   "
40233|NCT02530346|"~     This study will help determine wether mechanical bowel preparation before a colostomy~     closure is necessary in pediatric population, in order to avoid surgery related~     complications (surgical site infection and anastomosis leakage).~      Half of the population will go through the mechanical bowel prep before colostomy closure~     and the other half won´t. Complications rate will be compared among both groups.~   "
40234|NCT02530333|"~     Anterior cruciate ligament injury programs are less successful in women's basketball than~     soccer players, yet the reason for this discrepancy is unknown. Thus, this study will~     recruit high school aged girl's basketball and soccer players, randomized teams into control~     and experimental groups, administer an ACL injury prevention program in the experimental~     group and compare the two groups on their lower extremity biomechanics before and after~     completion of the program. Biomechanical analyses will help determine the extent to which~     women's basketball and soccer players respond differently to a uniform injury prevention~     program, and whether this prevention program provides an adequate stimulus to improve lower~     extremity biomechanics during basketball-specific tasks.~   "
40235|NCT02530320|"~     This multicenter, open-label, phase II trial aims to assess the safety and efficacy of~     palbociclib in adult patients with Oligodendroglioma or recurrent oligoastrocytoma~     anaplastic with the activity of the protein RB preserved.~   "
40236|NCT02530307|"~     This is a randomized, double-blind, placebo-controlled parallel group outpatient study that~     will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in~     a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in~     medically stable subjects following ischemic stroke.~   "
40237|NCT02530294|"~     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed~     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in~     subjects with axillary hyperhidrosis.~   "
40238|NCT02530281|"~     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed~     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in~     subjects with axillary hyperhidrosis.~   "
40239|NCT02530268|"~     The CORRONA Spondyloarthritis and Psoriatic Arthritis Registry is designed to create a~     national cohort of Spondyloarthritis patients cared for by rheumatologists to better~     understand the epidemiology and natural history of the disease, comorbidities, current~     treatment practices, response to therapy and outcomes related to medication therapy.~   "
40240|NCT02530255|"~     A method of detecting amyloid in the retina has been developed. A specially designed retinal~     camera will directly visualze and record retinal amyloid and via image processing will~     generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates~     with cerebral amyloid and has a predictive value in Alzheimer's disease.~      Telomere attrition accounts for cellular aging and is felt to have a pivotal role in~     Alzheimer's disease. The investigators plan to screen individuals to select those having~     retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter~     the RAI over time compared to placebo.~   "
40241|NCT02530242|"~     Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO~     (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature~     conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).~   "
40242|NCT02530229|"~     The purpose of this study is to analyze pre- and intra-operative joint aspirates of native~     joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee~     and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new~     diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and~     accuracy of these methods is compared to standard diagnostic methods in clinical routine,~     such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue~     culture and histology and sonication.~   "
40243|NCT02530216|"~     Healthcare delivery now mandates shorter visits with higher documentation requirements,~     undermining the patient-provider interaction. Electronic health records (EHRs) have the~     potential to improve outcomes and quality of care in this pressured environment, and are~     endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information~     Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to~     support value-based healthcare. However, EHR systems were principally designed to support~     the transactional needs of administrators and billers, less so to nurture the relationship~     between patients and their providers. The purpose of this research is to identify ways to~     use EHRs to support clinical gastroenterologists and their patients while meeting the~     meaningful use requirements of the HITECH Act.~      To improve clinic visit efficiency and meet criteria for meaningful use, investigators~     developed a patient-provider portal (P3) that systematically collects patient symptoms using~     a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS~     utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from~     a library of over 300 symptom attributes measuring the timing, severity, frequency,~     location, quality, and character of their GI symptoms, along with relevant comorbidities,~     family history, and alarm features. The system then automatically translates the patient~     report into a full narrative HPI available for use by GI providers in an EHR.~      In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS~     versus physician-documented HPIs, investigators found that blinded physician reviewers~     perceived that AEGIS HPIs were of higher overall quality, better organized, and more~     succinct, comprehensible, complete and useful compared to HPIs written by physicians during~     usual care in academic GI clinics. In the current study, investigators aim to evaluate~     computer-generated HPIs prospectively on a wider scale in diverse academic and~     community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention~     that ties patient HPIs to an individualized education prescription which guides the~     patient through a library of multi-media educational materials on GI symptoms, conditions,~     and treatments.~   "
40244|NCT02530203|"~     Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate~     the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days~     after surgery.~   "
40245|NCT02530190|"~     The study is a randomized clinical trial examining the effectiveness of massage and~     intermittent pneumatic compression on recovery from a 161-km ultramarathon.~   "
40246|NCT02530177|"~     The purpose of this study is to see how many patients develop hair, skin and nail changes~     due to cancer treatments. The investigators would like to study the clinical factors,~     genetic markers, and impact on patients' health-related quality of life to learn more about~     who is at greater risk. We trust that the study will improve our understanding of how cancer~     patients feel about their skin, hair, and nail conditions. This information will help us~     determine the burden on breast cancer patients and survivors. It will also help us learn how~     to prevent these conditions and it may improve the way we treat them and counsel patients.~   "
40301|NCT02529462|"~     This study evaluates the efficacy of NEUROPHARMAGEN pharmacogenetic test in the selection of~     the pharmacological treatments for patients with Major Depressive Disorder (MDD), both with~     and without psychiatric comorbidities. Patients will be randomly asigned to test-guided~     treatment prescription or to treatment as usual ina a 1:1 ratio; the results of the test~     will not be disclosed to the later until the end of the 3-month follow-up period. The study~     will compare the rate of treatment responders among both groups, based on patient-reported~     improvement collected by blind telephone interview.~   "
40247|NCT02530164|"~     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder.~     Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently~     from existing antidepressant interventions including trials of medication and psychotherapy.~     A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in~     a need for additional treatment options. Brain stimulation techniques are considered as a~     promising therapeutic approach in affective disorders like MDD. Transcranial direct current~     stimulation (tDCS) is a non-invasive brain stimulation method that has been largely~     investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been~     proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial~     in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective~     Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy~     superior to placebo treatment, tDCS alone and sertraline alone.~      The purpose of this study is to explore the sustained efficacy and tolerability of repeated~     tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with~     an SSRI will provoke an antidepressant effect while antidepressant medication alone (sham~     tDCS) did not. This will be measured by the change from baseline in the Montgomery Åsberg~     Depression Rating Scale (MADRS) scores after 6 weeks of treatment.~      In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with~     a diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode~     position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2~     weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration~     correspondent active tDCS, ramp in and ramp out periods only without intermittent~     stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months~     after the last tDCS treatment session. Before, during and after the treatment period~     different assessment scales will be conducted to record neuropsychological features and the~     course of the individual symptomatology.~   "
40248|NCT02530151|"~     The purpose of this study is to determine whether intraoperative (during surgery) morphine~     and clonidine hip injections are effective in postoperative pain management for patients~     undergoing hip arthroscopy.~   "
40249|NCT02530138|"~     Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver~     disease in the world. The only approved treatment for it is lifestyle modification and~     weight loss; however, there is no evidence for patients with normal or low body mass index~     (BMI).~      The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD~     patients with normal or low BMI.~      Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial~     protocol, 21 cases and 21 controls will be individually matched based on age and sex. This~     42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or~     a placebo capsule. Both groups will be advised to follow an energy balanced diet and~     physical activity recommendations.~   "
40250|NCT02530125|"~     The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the~     immune system in relation to its ability to fight cancer cells. Many cancers can be brought~     to a phase called complete remission (no cancer is found) but have a chance that they may~     come back. Researchers are working to improve therapy and to find new drugs that lower the~     chance of disease coming back. This study uses a drug called pidilizumab. The drug targets~     our immune system. It can change how our immune system finds cancer cells. The drug may kill~     any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug,~     pidilizumab, is being studied in other cancers.~   "
40251|NCT02530112|"~     To identify outcome measures for cancer control in Head and Neck cancer patient populations~     at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional~     outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately~     develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's~     quality of life, and help with therapeutic interventions and explanation of expectations~     prior to surgery.~   "
40252|NCT02530099|"~     Often the less experienced as medical students are charged with the role as camera navigator~     and assistant during laparoscopic surgery. Camera navigation is generally considered an easy~     skill, but it requires specific psychomotor and visuospatial skills. Simulation-based~     training can improve surgical skills, but little is known on how to optimally structure a~     training program to acquire camera navigation skills. The objective of this trial is to~     examine if simulation-based laparoscopic camera navigation skills transfer to the operating~     room after practicing one of two fundamentally different laparoscopic tasks on a simulator.~     The first group practice a procedure on a virtual reality simulator, the second group~     practice camera navigation on a virtual reality simulator and the third group receive no~     training. All participants are tested as camera navigators and assistants during a procedure~     in the operating room.~   "
40253|NCT02530086|"~     A prospective randomized trial comparing non-operative management of small bowel obstruction~     due to adhesions with or without a naso-gastric tube (NGT).~   "
40254|NCT02530073|"~     The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to~     restore adequate lung growth for neonatal survival.~   "
40255|NCT02530060|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of~     rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of~     Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to~     healthy Japanese adult male participants.~   "
40256|NCT02530047|"~     The goal of this clinical research study is to find the highest tolerable dose of human~     mesenchymal stem cells with interferon beta (MSC-INFβ) that can be given to patients with~     ovarian cancer and to test the safety of the MSC-INFβ.~   "
40257|NCT02530034|"~     The goal of this clinical research study is to find the highest tolerable dose of Hu8F4 that~     can be given to patients with advanced leukemia.~      This is the first study using Hu8F4 in humans.~   "
40258|NCT02530021|"~     There are many patients hospitalized for chest pain, which don't have high risk features~     that require invasive coronary angiography, but are considered intermediate risk and for~     which ischemic heart disease can not be excluded.~      The current management for these patients is to perform a non invasive test in order to~     classify their risk.~      Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is~     non-invasive, and does not involve radiation or intra-venous contrast. The test is limited~     for many patients, because of un-ability to exercise, or because of non-interpetable Electro~     Cardio-Graphy (ECG).~      Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate~     variability testing is a non-invasive ECG monitoring technique.~      The study design is to identify hospitalized patients who are candidates for non-invasive~     stress testing, and to monitor their heart rate variability for one hour prior to the stress~     test.~   "
40302|NCT02529449|"~     The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of~     ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2~     weeks.~   "
40259|NCT02530008|"~     This is a cohort study of women with suspected or confirmed recurrent breast cancer, with~     accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent~     metastatic disease. Study participants will be ascertained from the population of all~     persons greater than eighteen years of age receiving care at the clinical practices of the~     Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this~     study is to identify the genetic and molecular markers of molecular evolution identified in~     patients who have progressed from a primary diagnosis of breast cancer to recurrent,~     metastatic disease. As an observational study, this study seeks to gather data regarding the~     molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs~     and ultimately progresses. We anticipate enrolling 50 women with recurrent breast cancer who~     meet eligibility requirements for this study. Participation in this study will include the~     following: a biopsy and blood collection, completion of the study questionnaire, an optional~     bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a~     optional bone marrow aspirate collection at each progression time point. The study~     participants' medical information will be updated and changes in disease status will be~     captured on a regular basis.~   "
40260|NCT02529995|"~     A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics~     and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small~     Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor~     Receptor Tyrosine Kinase Inhibitor Agent~      Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291~     and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291~     administered orally once daily in Chinese patients with locally advanced or metastatic non~     small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved~     Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.~      2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given~     orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed~     following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment~     of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response~     Evaluation Criteria in Solid Tumours (RECIST) version 1.1.~   "
40261|NCT02529982|"~     Diabetes mellitus is the most common endocrine disorder, causes many complications such as~     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,~     but most of them have side effects. Recently, the use of natural plant products has gained~     more attention among scientists in order to prevent diabetic vascular complications.~     Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be~     non-toxic and exhibits various bio¬logical activities such as anti-oxidant,~     anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in~     reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive~     and safe. Most of the studies conducted on animal model, and just a few of them are on human~     model. The present study was planned to evaluate the effects of curcumin supplementation on~     serum levels of glycemic control, lipid profile, inflammatory markers, and oxidative stress~     in patients with type 2 diabetes~   "
40262|NCT02529969|"~     Diabetes mellitus is the most common endocrine disorder, causes many complications such as~     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,~     but most of them have side effects. Recently, the use of natural plant products has gained~     more attention among scientists in order to prevent diabetic vascular complications.~     Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be~     non-toxic and exhibits various bio¬logical activities such as anti-oxidant,~     anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in~     reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive~     and safe. Most of the studies conducted on animal model, and just a few of them are on human~     model. The present study was planned to evaluate the effects of curcumin supplementation on~     serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes~   "
40263|NCT02529956|"~     To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in~     subjects with mild to moderate plaque psoriasis.~   "
40264|NCT02529943|"~     Is there a relationship between changes in motor evoked potential latency intraoperatively~     and post-operative changes in walking function in patients undergoing spinal decompression.~   "
40265|NCT02529930|"~     This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in~     patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This~     study will recruit approximately 27-40 female patients with high grade cervical~     intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.~   "
40266|NCT02529917|"~     Forty physically active men and women aged 18-45y will take part in an 8-week resistance~     training program, randomized (double blind) 1:1 into each of two groups. Twenty participants~     will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein~     and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation~     (matched to the hemp for macronutrients and calories) during eight weeks of training. Each~     participant will complete testing before and after the intervention for assessment of body~     composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of~     inflammation, and bone resorption. Over the 8-weeks of training, participants will train~     four-five days per week for 1-1.5 hours per session with exercises targeting all major~     muscle groups. The training will involve a two day split where different muscle groups are~     trained on two consecutive days (day 1 involves chest, back, and arms; day 2 legs,~     shoulders, and abdominals). Resistance training will provide the necessary stimulus for~     protein synthesis to optimize the effect of a protein-containing nutritional supplement. The~     hemp or soy powder will be consumed in two doses (i.e. 30 g powder containing 20 g protein~     per dose) immediately after exercise sessions and one hour after exercise. This dosing~     regimen is optimal for stimulating muscle protein synthesis and building muscle mass . On~     the one non-training day per week the two doses will be consumed with meals.~   "
40525|NCT02526550|"~     This study was undertaken to assess the immunogenicity and safety of a booster dose of a~     live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination~     with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the~     duration interval after primary vaccination on subsequent booster response.~   "
40267|NCT02529904|"~     Influenza infection is related to significant morbidity and mortality in children. The~     trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children~     and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is~     unable to be administered to children under 2 years old. The MF59 adjuvanted influenza~     vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza,~     including in children.~      The study aims to assess early gene transcriptional responses to priming and boosting with~     MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish~     correlations with haemagglutination inhibition (HAI) titers. It will be an open label study~     with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults~     allocated to group 4.~   "
40268|NCT02529891|"~     Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD),~     affecting the decline of pulmonary function, quality of life and increasing morbidity. The~     use of validated biomarkers could help to identify the etiology of exacerbation and to~     prescribe antibiotherapy when indicated.~      The analysis of exhaled air allows measuring different volatile organic compounds (VOC)~     which reflect local or systemic inflammation and oxidative stress. The relationship between~     the presence of some of these compounds and the exacerbation of COPD has never been studied.~      The aim of this study is to identify a cluster of VOC in COPD patients during an acute~     exacerbation of the disease, compared to a stable condition (3 months after discharge).~     Investigators also will seek for a relationship between VOC and the etiology of exacerbation~     (bacterial, viral, inflammatory).~   "
40269|NCT02529878|"~     The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an~     initially unresectable gastric cancer to a resectable cancer. Previous studies showed~     patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy~     and subsequent curative surgery. The key of conversion therapy of initially unresectable~     metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF~     receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The~     purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel~     chemotherapy plus Apatinib in the conversion therapys of metastatic gastric cancer.~   "
40270|NCT02529865|"~     The purpose of this study is to evaluate the efficacy and safety of periurethral injection~     of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary~     incontinence.~   "
40271|NCT02529852|"~     There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin,~     vincristine, and prednisone) that can be given to patients with diffuse large B cell~     lymphoma.~      The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide~     found in Part 1 can help to control the disease.~      The safety of this drug combination will be studied in both parts.~   "
40272|NCT02529839|"~     The purpose of this study is to evaluate the safety and efficacy of an immunoablative~     nonmyeloablative conditioning protocol for autologous bone marrow transplantation in~     patients with Multiple Sclerosis. Patients meeting inclusion and exclusion criteria will~     start an immunoablative nonmyeloablative conditioning regimen followed by autologous bone~     marrow transplantation. Patients will be followed for one year by a neurologist to evaluate~     the course of the disease after treatment.~   "
40273|NCT02529826|"~     Due to remarkable advances in cancer treatments, the investigators are witnessing a growing~     population of long-term survivors of childhood malignancies. However, fertility in adult~     life may be severely impaired by gonadotoxic therapies. Since prepubertal boys cannot~     produce spermatozoa, banking of testicular tissue prior to gonadotoxic treatment is a~     crucial step towards fertility preservation for this population. Several centers around the~     world are now cryopreserving testicular tissue for prepubertal boys in anticipation that~     future technologies will allow the utilization of the banked samples for fertility~     restoration.~      Testicular tissue cryopreservation has now emerged as the leading strategy for fertility~     preservation in prepubertal boys before gonadotoxic treatments. Fertility restoration can~     theoretically be obtained after allo-transplantation of testicular tissue fragments that~     preserve both the SSCs and the supporting microenvironment (spermatogonial stem-cell niche).~   "
40274|NCT02529813|"~     Sometimes researchers change the DNA (genetic material in cells) of donated T-cells (white~     blood cells that support the immune system) using a process called gene transfer. Gene~     transfer involves drawing blood from the patient, and then separating out the T-cells using~     a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then~     inject the changed T-cells into the body of the patient.~      The goal of this clinical research study is to find the highest tolerable dose of~     genetically changed T-cells that can be given to patients. Researchers want to learn if~     these genetically changed T-cells may be able to attack cancer cells in patients with~     advanced B-cell lymphoma or leukemia.~   "
40275|NCT02529800|"~     To investigate the PK charateristics and the effect of food on the PK in healthy male~     volunteers who receive HIP1402 capsule in fed versus fasted condition~   "
40276|NCT02529787|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and~     Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)~   "
40277|NCT02529774|"~     This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant~     systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete~     hepatic resection for Chinese patients with metastatic colorectal cancer.~   "
40278|NCT02529761|"~     This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE~     combined with sorafenib compared with TACE monotherapy in term of overall survival in~     intermediate-stage HCC.~   "
40313|NCT02529306|"~     Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to~     check if there is a correlation between serum or hair testosteron levels and serum or hair~     cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation~     between serum and hair testosterone levels and cortisol levels and serum inflammatory~     markers.~      If such correlation will be found- then it is possible that excess cortisol or an abnormal~     inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.~   "
40279|NCT02529748|"~     Dermal transfer efficiency has been defined as the amount of material that moves from one~     surface to another following contact. The investigators propose to measure dermal transfer~     efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to~     mouth, (4) clothing to skin, (5) gloves to skin, and (6) air to skin. First, the~     quantitative dermal transfer will be measured for the two selected test substances (lead,~     Tinopal) for each of these six pathways. The relative quantities of dermal transfer will~     also then be compared between the different transfer pathways (e.g., is skin to skin~     transfer greater or less than clothing to skin transfer?). And second, the pattern of~     transfer will be characterized semi-quantitatively (e.g., does dermal transfer occur~     consistently and evenly to the skin from different reservoirs?).~   "
40280|NCT02529735|"~     Non-invasive measurement of blood pressure is an instrument governed nursing routine care.~     The use of an automated oscillometric cuff is a common technique and validated if this is~     done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the~     right atrium (the brachial site) . If cons-indication to use the brachial site, measurements~     are frequently performed at the ankle, calf or thigh. Among the blood pressure values~     measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific~     property of which the observed values are closest to the reference values (brachial).~      The objective of this study is to measure the non-invasive blood pressure values at three~     sites of the lower limb, to compare the reference value to determine which alternative site~     should be preferred when the reference measurement is not feasible .~      We want to determine the alternative site to obtain values as close as the measured values~     of the reference site. The three study sites are the thigh, calf and ankle. The reference~     site recommended for monitoring non-invasive blood pressureis the arm.~      It is also assessing the impact of certain parameters on the primary endpoint:~        -  Physiological parameters: gender, weight, height, age, systolic blood pressure~          reference, listed measures.~        -  A parameter related to measurement: discomfort felt when the blood pressure outlet.~        -  Exposure setting: smoking.~   "
40281|NCT02529722|"~     IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an~     important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per~     million age-related population in adults and 3-5/new cases/year/per million age-related~     population in children and progresses to need of renal replacement treatment in 5-15% at 10~     years and in about 20% at 20 years. The variability of the clinical course anticipates~     different treatment options. There is an absolute need of validated biomarkers to predict~     risk of progression and indication for treatment at early stages, when lesions can be~     reversible. This study aimed to evaluate IgAN progression and its histological and clinical~     correlates.~   "
40282|NCT02529709|"~     The purpose of this study is to see if a high-protein meal leads to a better postprandial~     (after a meal) blood lipid profile compared to a high-monounsaturated meal.~   "
40283|NCT02529696|"~     Maintenance of analgesia during a patient stay in the hospital has been an important area of~     investigation after demonstrating a direct correlation between level of sedation and~     mortality in the ICU setting. This study will investigate the use of accelerometers in~     determining patient sedation level.~   "
40284|NCT02529683|"~     One arm clinical trial of Nuvaring use for six months among 200 previously contracepting~     HIV-negative women (COCPs or DMPA) aged 18-35 in Kenya, where no vaginal rings are~     licensed/available for contraception or other indications. This was meant to be a formative~     research study to understand the predictors of acceptability and adherence to a~     contraceptive vaginal ring, and its immunoogical and microbiological effects over six months~     of product use.~   "
40285|NCT02529670|"~     Chronic axial low back pain is a public health problem and has a high socioeconomic impact.~     The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies~     responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level~     laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project~     is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and~     treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into~     three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in~     a prone horizontal position under anesthetic monitoring. The intervertebral foramen between~     the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by~     fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without~     vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact~     with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds~     at 42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber~     crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog~     scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively,~     to study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA~     seek, RNA isolation and ATP quantification. The data will be evaluated for normality and~     subjected to appropriate statistical analysis, in order to seek representation, as same as~     the level of significance of the studied samples.~   "
40296|NCT02529527|"~     Strong evidence supports that preconception care, or care to optimize a woman's health~     health prior to pregnancy, can improve birth outcomes. Preconception health counseling~     covers a broad range of topics, including: desire for pregnancy, obstetric history,~     nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and~     contraception. Despite calls from public health organizations and experts in the field for~     universal access to preconception care, most US women do not receive any health counseling~     to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it~     is critical that routine primary care serve as a venue for the provision of this important~     service. From a patient's perspective, improving preconception health involves many health~     behavior changes. As such, patient engagement and education regarding preconception health~     must be a primary focus. Several preconception health promotion tools have been developed~     for patients to date; few are truly patient-centered and even fewer have been rigorously~     evaluated.~      This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health~     education tool designed for women of reproductive age receiving primary care. MyFamilyPlan~     is truly innovative in two key ways:~        -  MyFamilyPlan is a web-based preconception health self-assessment. This will allow for~          the employment of skip logic to individualize the questionnaire and subsequent health~          recommendations for each patient.~        -  Recognizing that preconception care is relevant to all women at risk of pregnancy,~          MyFamilyPlan has been designed for utilization in a primary care setting.~      This preconception health education tool will be tested using a randomized controlled~     design. This study will measure whether or not exposure to MyFamilyPlan promotes the~     discussion of preconception health issues in primary care encounters (primary outcome). It~     will also evaluate whether the intervention affects participant self-efficacy in planning a~     healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed~     here will improve the quality of evidence for preconception health education tools. Should~     it demonstrate effectiveness, it will also result in a new tool that could be made more~     widely available to promote preconception health.~   "
40286|NCT02529657|"~     Each year, more than one million individuals worldwide are submitted to laminectomies, with~     a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main~     cause of ''failed back surgery syndrome'' and associated with increased risk of~     complications during revision surgery. The postoperative epidural scar can cause extradural~     compression or dural tethering, which results in recurrent radicular pain and physical~     impairment. Several studies in the literature are signalizing that Low-Level-Laser-Therapy~     (LLLT) is proven to be an effective tool to assist the inflammatory process and wound~     healing, as well to prevent infection. Thus, the objectives of this project are to delineate~     and evaluate the LLLT effects in spinal surgery. A prospective randomized, controlled trial~     with a total of 48 patients who underwent laminectomy, were divided into 2 groups. In the~     first group, 25 patients received LLLT during the surgical procedure over dura mater, over~     subcutaneous and on the skin, as well as 24h and 72h post surgery. In the second group, 23~     patients were induced to think they will be getting the same treatment, although the laser~     is not operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine~     kinase were evaluated in the second and fifth days after surgery, digital temperature will~     be measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes~     post Laser application. The drainage output was collected in the first three days following~     surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in~     24h and 48h. The data was evaluated for normality and subjected to appropriate statistical~     analysis, in order to seek representation, as same as the level of significance of the~     studied samples.~   "
40287|NCT02529644|"~     The primary aim of this study is to fully test a culturally/religiously-tailored,~     church-based HIV screening intervention (TIPS) against a standard HIV information~     intervention on HIV screening rates at 6 and 12 months with adult African American church~     members and community members who use church outreach services. Our secondary outcome is to~     reduce sexual risk behaviors with this same population.~   "
40288|NCT02529631|"~     This trial compares two treatment methods:~        1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in~          overweight adults. Important is also that it is taken along with a reduced-calorie and~          low-fat diet.~        2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two~          main meals with the highest fat content, indicated for weight maintenance and weight~          loss.~   "
40289|NCT02529618|"~     The purpose of this study is to assess a new screening tool for sideline evaluation of~     concussion injuries in athletes. iDETECT is a new technology that combines several elements~     of recommended concussion screening tools into a single, portable device.~   "
40290|NCT02529605|"~     This is a single dose, randomized, cross-over pharmacokinetic study in healthy volunteers~     (n=12) of two dietary supplement formulations. The Product B® IsaGenesis® formulation~     represents a newer reformulation of an existing product known simply as IsaGenesis®. Beyond~     some changes in the relative abundance of some of the constituents of the earlier~     IsaGenesis® formulation, the Product B® IsaGenesis® product has been formulated as a~     liquid-gel formulation (rather than a dried powder extract) which is theorized to enhance~     the absorption and bioavailability of the contained botanical constituents. The purpose of~     this study is to compare the two dietary supplement formulations relative to the absorption~     of two compounds contained within the supplement known as the flavonolignans silybin A and~     silybin B into the bloodstream after oral administration of capsules.~   "
40291|NCT02529592|"~     The objective of the present study is to specifically assess the effect of~     lipopolysaccharide (LPS) administration on the development of behavioral symptoms and the~     underlying contribution of inflammatory processes. In particular, the investigators will~     assess the development of subjective and objective behavioral symptoms. In addition, the~     investigators will determine whether some psychological trait or state can predict and/or~     modulate the LPS-induced inflammatory and behavioral responses.~      Twenty-five healthy subjects will be included. A placebo-controlled, double-blinded and~     cross-over design will be used. Subjects will receive an intravenous injection of endotoxin~     at 2 nanogram/kilogram (ng/kg) of body weight and an intravenous injection of sodium~     chloride as placebo of endotoxin injection at two different occasions.~      Prior to inclusion and randomization, subjects will come at the hospital and will receive a~     medical examination. Psychological variables that could affect the behavioral (or immune)~     response to LPS will be assessed at that time, using several self-assessment questionnaires.~      On the trial days, injection of endotoxin or sodium chloride will be performed and blood~     samples will be taken just before the endotoxin or sodium chloride injection and 1, 1.5, 2,~     3, 4, 5, 6 and 7.5 hours after the injection. Blood samples will be used to measure several~     inflammatory and immune markers. Urine samples will be taken before the endotoxin or sodium~     chloride injection and as late as possible after the injection. Subjects will wear T-shirt~     all day. Urine and T-shirt samples will be used for behavioral assessment and analysis of~     body odor compound.~      Self-assessment questionnaires assessing behavioral and psychological variables will be~     completed by participants just before the endotoxin or sodium chloride injection, three~     hours and 7.5 hours after the injection. A short questionnaire assessing sickness behavior~     (SicknessQ) will be repeatedly completed by participants from just before to 7.5 hours after~     the endotoxin or sodium chloride injection.~      Several behavioral tests will be used, including a motivation task, a test assessing~     behavioral response to negative and sickness stimuli. Analysis of gait and motion, as well~     as of social interactions, will be performed. Photographs will be taken for the further~     rating of the faces.~   "
40292|NCT02529579|"~     The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined~     gemcitabine therapy on advanced pancreatic cancer.~   "
40293|NCT02529566|"~     Investigate the potential of tissue grafting that includes human mesenchymal stem cells in~     the repair and potential stabilization of the degenerative Lumbar disk and facet joint~     denovo and at the time of surgical reconstruction. Our hypothesis proposes that~     stabilization will help restore normal structure and function in the degenerative lumbar~     spine may decrease chronic low back pain associated with the biomechanical demise of the~     degenerative disk or facet and may improve the natural history of adjacent segment disease~     found after spinal surgery.~   "
40294|NCT02529553|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3076226 in participants with advanced or metastatic cancer.~   "
40295|NCT02529540|"~     Two-month randomized trial comparing three groups.~   "
40297|NCT02529514|"~     Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled~     cardiac surgery.~   "
40298|NCT02529501|"~     The purpose of this study is to describe, in real-life conditions, the factors influencing~     the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient~     surgery.~   "
40299|NCT02529488|"~     The purpose of this study is to investigate visual outcomes and assess safety at 12 months~     (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™~     Presbyopia-Correcting IOL.~   "
40300|NCT02529475|"~     -  This prospective study aims to better characterize inner ear's perilymphatic structures~          with Magnetic Resonance Imaging using contrast media and delayed injection in healthy~          subjects~        -  MR Perfusion Imaging will be assess in both cochlea as well~        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging~   "
40303|NCT02529436|"~     Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and~     associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without~     ADAD. If depression and anxiety disorders are comorbidities frequently associated with~     dementia, such level of AD exposure suggests an overuse of AD in this population.~      Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess~     overuse associated with off label prescriptions (no validated indication and excess in~     prescription duration) Main objective: to assess the prevalence of AD overuse associated~     with off label prescriptions (no validated indication and excess in prescription duration)~     in patients aged 70 years and over with ADAD.~      Secondary objectives:~        1. To assess the prevalence of AD prescribed for a non validated indication~        2. To assess the prevalence of AD prescribed with excess in prescription duration~        3. To assess the prevalence of psychotropic coprescription and notably the prevalence of~          the neurologic iatrogenic alerts as defined by the French National Authority for Health~        4. To assess factors associated to AD overuse Method: A transversal monocentric study in~          the geriatric day Bretonneau unit will be performed. Study will be proposed to all~          eligible patients (with non-opposition of the patient or of his legal representative to~          the collection of his personal data). Included people will have no supplementary~          clinical or complementary investigations. The geriatrician in charge will have to~          systematically collect the indication and the history of the AD treatment. At the end~          of the evaluation performed in the geriatric day unit, the geriatrician will have to~          conclude to the AD overuse or not associated with off label prescription. Doubtful case~          will be examined by a validation committee.~      Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and~     dementia according to DSMIV criteria, whatever its level and antidepressant prescription.~      Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant~     (data from French Health Insurance), the number of eligible patients consulting in the~     geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their~     personal data and if the overuse of AD is near 50%, precision of the result will be 12.8%~     (95%CI bilateral).~      Duration of inclusion: 6 months Duration of patient's participation: one day~   "
40304|NCT02529423|"~     The study examines the feasibility and effectiveness of two different nutritional strategies~     (multi‐nutrient supplement and food‐related behavioural change) to prevent depression in~     high‐risk overweight European Union citizens. Interventions will last 12 months. Design is a~     two‐by‐two factorial randomized controlled prevention trial with four intervention groups:~        1. Control group (daily placebo supplements)~        2. Multi-nutrient supplementation group (daily multi-nutrient supplement)~        3. Food-related behavioural change group (food-related behavioural activation focusing on~          improving overall diet + placebo supplements)~        4. Multi-nutrient supplementation + food-related behavioural activation group (daily~          multi-nutrient supplement + food-related behavioural activation focusing on improving~          overall diet).~      Follow‐up assessment will be conducted at 3, 6, and 12 months for primary and secondary~     endpoints, and during intervention for compliance, adverse events and mediating~     variables.Data will first be analyzed according to the intention‐to‐treat principle, using~     (mixed model) analysis of covariance with primary and secondary endpoints, testing for the~     effects of the two nutritional strategies separately as well as combined.~   "
40305|NCT02529410|"~     100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular~     pacemaker Feasibility study with 6 month outcome data~   "
40306|NCT02529397|"~     This study will examine the effects of providing subjects who have attention deficits, with~     or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with~     Working Memory computerized training and explore whether this training is a feasible way to~     help them better engage in a weight loss treatment program, thereby enhancing weight loss~     results. Half of the participants will receive five weeks of online adaptive WM training~     concurrently while attending an in-person 24-week behavioral weight management program and~     half will receive five weeks of a non-adaptive form of cognitive training concurrently while~     attending a 24-week behavioral weight management program in person.~   "
40307|NCT02529384|"~     Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is~     still challenge for radiologist. This study is going to evaluate multi-b value diffusion~     weighted imaging in discrimination of breast benign and malignant lesions and explore the~     diagnostic effect of the combination of multi-parameter. At the same time, pathological~     specimens of patients will be collected. The relationship between magnetic resonance(MR)~     parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted~     imaging can improve diagnosis for breast lesion and provide the basis for clinical~     treatment. The fundamental of pathology on MR signal change will be further expounded.~   "
40308|NCT02529371|"~     The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA~     cleared non-invasive urine collection device for men.~   "
40309|NCT02529358|"~     The study presents findings from a randomized clinical trial evaluating the effects of text~     messages encouraging short emotion regulation exercises on the course of psychopathological~     symptoms after inpatient treatment for depression. In this context, the study also compares~     the effectiveness of standardized versus personalized text messages.~   "
40310|NCT02529345|"~     The objective of this clinical investigation is to evaluate the clinical outcome (up to 12~     months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high~     risk for carotid endarterectomy requiring carotid revascularization due to significant~     extra-cranial carotid artery stenosis.~   "
40311|NCT02529332|"~     Omega-3 supplementation has been shown to have neuroprotective and potentially~     anti-inflammatory properties in both central and peripheral nerve injuries. The~     investigators are studying to see if omega-3 supplementation will affect olfactory (smell)~     function in patients with olfactory dysfunction following endoscopic removal of pituitary~     tumors.~   "
40312|NCT02529319|"~     This proposal is aiming at modifying and improving persistent AF management guidelines by~     evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related~     effect on procedural outcome.~      OBJECTIVES:~      Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an~     ablation procedure in treating persistent AF. Results from the DECAAF study show that one of~     the most important predictors of ablation outcome was the degree of ablation of the fibrotic~     tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better~     the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients~     will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI +~     fibrosis-guided ablation. The investigators will follow patients longitudinally to assess~     the primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial~     fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines [2]). The~     investigators hypothesize that patients receiving fibrosis-guided ablation in addition to~     conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation~     alone.~      The investigators will also examine the efficacy of the fibrosis-guided ablation~     intervention on a number of secondary or exploratory outcomes including the individual~     components of the primary outcome (atrial fibrillation, atrial flutter and atrial~     tachycardia), symptomatic atrial arrhythmia, AF cycle length/regularity/termination,~     cardiovascular (CV)-related hospitalization, CV-related mortality, quality of life~     measurements (University of Toronto Atrial Fibrillation Severity Scale (AFSS), and AF~     burden.~      The safety of the two interventions will be evaluated by evaluating peri-procedural~     complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury,~     cardiac perforation, heart failure, and death.~   "
40539|NCT02526368|"~     This is a pilot study evaluating pre-surgical patients with histologically confirmed~     localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection~     and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical~     prostatectomy.~   "
40314|NCT02529293|"~     This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the~     feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone~     insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.~      Each subject will be randomly allocated to a sequence of four treatments, i.e. two single~     doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of~     BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.~   "
40315|NCT02529280|"~     Increasing Access of Latinas into Breast Cancer Clinical Trials aims to develop and pilot~     test a multi-communications approach - using a culturally relevant computer video, a~     tailored booklet and a patient navigator (PN) - to empower Latinas to make informed~     decisions about breast cancer clinical trials (BCCTs). Latinos represent 15% of the U.S.~     population but only 5.6% of participants in National Cancer Institute (NCI) treatment~     clinical trials, resulting in disparities in cancer outcomes and jeopardizing the~     generalizability of trial findings. In response, this study will develop and evaluate~     communication and health-system-change strategies to facilitate Latinas' access to BCCTs at~     the Cancer Therapy and Research Center at The University of Texas Health Science Center at~     San Antonio (CTRC-UTHSCSA). The CTRC-UTHSCSA, an NCI-designated Cancer Center located in~     South Texas, serves a culturally and ethnically diverse population that historically has low~     participation in clinical trials, especially among those with breast cancer, the No. 1~     cancer killer of Latinas.~   "
40316|NCT02529267|"~     Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of~     non-fatal injury in women worldwide. 1 in 6 women attending surgical fracture clinics have a~     history of IPV in the past year. Given the high prevalence and costs associated with IPV,~     there is a need to identify health outcomes associated with IPV, the incidence of new and~     worsening cases of IPV, and resource use among IPV victims. This prospective cohort study of~     women with fractures and dislocations will assess differences in injury-related outcomes~     (time to fracture healing, injury-related complications, and return to pre-injury function)~     between abused and non-abused women. This study will also determine whether a~     musculoskeletal injury can lead to new or worsening abuse by an intimate partner and how~     patterns of IPV change over time following musculoskeletal injuries.Finally, the proposed~     study will also inform the feasibility of a larger multinational cohort study.~   "
40317|NCT02529254|"~     The purpose of this study is to determine if video coaching is an efficient way of teaching~     surgical skills outside of the operating room for surgical residents.~   "
40318|NCT02529241|"~     To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a~     single oral dose in healthy male subjects.~      To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male~     subjects.~   "
40319|NCT02529228|"~     This study examines the effect of meal frequency and meal composition on risk factors of~     cardiometabolic disease.~   "
40320|NCT02529215|"~     Communication and teamwork failures are the leading causes of errors in healthcare settings.~     In situ mock code simulations are a potential means to train team-based skills using~     simulation within real clinical care environments where errors occur; however, debriefing~     discussions often focus on gaps in learners' clinical skills as opposed to team functioning.~     This study aims to determine whether learners who are pre-trained using just-in-time~     simulation regarding CPR quality and medication administration will exhibit improved~     performance with respect to these skills during in situ mock codes as well as improved team~     functioning.~   "
40321|NCT02529202|"~     The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns~     ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic~     encephalopathy.~   "
40322|NCT02529189|"~     The mainstay treatment for reducing the symptoms of angina and long-term risk of heart~     attacks in patients with heart disease is stent implantation in the diseased coronary~     artery. Whilst this procedure has revolutionised treatment the incidence of secondary events~     remains a concern. These repeat events are due in part to continued enhanced platelet~     reactivity, endothelial dysfunction and a phenomenon called 'restenosis' i.e. the stent~     becomes blocked ultimately requiring another expensive and risky procedure. In this study it~     will be determined whether a once daily inorganic nitrate administration might favourably~     modulate platelet reactivity and endothelial function leading to a decrease in restenosis.~   "
40323|NCT02529176|"~     This is a randomized trial of a best-practice alert delivered via the electronic medical~     record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month~     period. The alert notifies physicians that their order for continuous cardiac monitoring~     (telemetry) for a given patient has exceeded the duration recommended by national guidelines~     and offers them the opportunity to discontinue monitoring if they feel it is clinically~     appropriate. Physicians will be randomized to either receive the BPA or not, with the~     anticipation that physicians in the intervention arm will discontinue unnecessary telemetry.~   "
40324|NCT02529163|"~     As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the~     medical field with special attention given to mental health in particular. One aspect of~     metal health that has not seen the incorporation of ICPs is in the area of schizophrenia.~     Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years~     of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life~     schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic~     symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP~     group. The primary outcome measure will be reduction in symptom severity as measured by~     clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS).~     If successful, this study will provide strong evidence to implement LLS-ICP across different~     inpatient and outpatient settings.~   "
40380|NCT02528435|"~     Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in~     high-dose as part of the initial phase of treatment, gastrointestinal toxicity is a known~     problem. However when children reach maintenance treatment with low-dose methotrexate this~     is not described as a significant challenge. Children with juvenile idiopathic arthritis are~     another patient group receiving low-dose methotrexate. Among these patients gastrointestinal~     intolerance is such a significant problem that treatment may be ceased. The aim of this~     project is to create a greater understanding of gastrointestinal intolerance associated to~     low-dose methotrexate treatment by investigating the differences between these two patient~     groups, investigating genetic and psychological factors.~   "
40325|NCT02529150|"~     One in four deaths in the United States is due to cancer, and one in three women will~     develop cancer in her lifetime. Despite improvements in survival among other forms of~     cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer~     will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2~     Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are~     high.4 Therefore, interventions focused on preventing recurrence or slowing progression of~     EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a~     dose response exercise intervention trial to examine the dose response effects of aerobic~     exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers~     would like assurance that the investigators can recruit ovarian cancer patients into an~     exercise study and that these women will do the exercise protocol we plan to prescribe in~     our high dose of exercise.~   "
40326|NCT02529137|"~     The primary objective of this study is to show safety and effectiveness of the PDx for In~     Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital~     images of surgical pathology slides.~   "
40327|NCT02529124|"~     The focus is healthy ageing, i.e. delaying the deterioration in health status in older~     adults. Loss of lean tissue (skeletal muscle) mass, a process termed sarcopenia, or bone~     tissue mass, a process called osteopenia, is a consequence of aging per se, modified by~     nutrition and lifestyle behaviour.~      The aim is to conduct a study of body composition, physical activity, muscle function and~     ability to undertake activities of daily living in older Irish men and women and to~     investigate the effect of a six month period of nutrient support, or nutrient plus physical~     activity on lean tissue mass and function and bone mass in men and women aged 50 to 70~     years.~   "
40328|NCT02529111|"~     The interventional catheterization allows the percutaneous treatment of congenital heart~     diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with~     stochastic side effects worrying at the child's. The software Echonavigator allows to~     merge the ultrasound image and fluoroscopic. This innovative software facilitates the~     procedures and reduce the irradiation time in some adult procedures.~      The aim of this study was to validate the image fusion in children.~   "
40329|NCT02529098|"~     This study will highlight differences in cortical activation between asymptomatic and~     symptomatic patients.~   "
40330|NCT02529085|"~     The present project aims to determine the underlying mechanisms for the switch from failure~     to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary~     objective is to describe the evolution of circulating hormones involved in feeding and~     appetite regulation during the 4 first years of life. The secondary objective is to make~     this blood bank available for other research projects and particularly the investigation of~     hormones involved in hypogonadism.~      Over the last ten years, the age at diagnosis in PWS has fallen significantly and the~     majority of cases is now diagnosed during the 1st trimester of life giving the possibility~     to collect precise clinical data and serum samples at early stages. The investigators of the~     project are involved in the care of patients with PWS and have a devoted clinic and an~     organized network in their country through clinical networks or patient associations.~   "
40331|NCT02529072|"~     Patients will be randomized to one of two treatment arms - Group I and Group II. Group I~     will receive nivolumab monotherapy until surgical resection, and Group II will receive~     nivolumab alone and with DC vaccine therapy until surgical resection. During surgical~     resection blood and tumor samples will be assessed and compared. Following surgery, both~     groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until~     confirmed progression.~   "
40332|NCT02529059|"~     This study aims to investigate whether substitution of Efavirenz (EFV) as the~     Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with~     Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination~     (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity~     associated with EFV, continued virological suppression and immunological reconstitution and~     whether this is associated with an improvement in quality of life, sleep, anxiety/depression~     and neurocognitive function; the impact of switch on adherence will also be investigated.~   "
40333|NCT02529046|"~     In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation~     associated with aerobic exercise on body fat and lipid profile in obese women.~   "
40334|NCT02529033|"~     The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac~     output) is as equivalent in determining the hemodynamic assessment in cardiac surgical~     scenarios as the most often used pulmonary artery catheter, which is much more invasive than~     the Lidco Rapid. This will be accomplished through online surveys which have different~     cardiac surgery scenarios and will be distributed to cardiac fellowship trained~     anesthesiologists. The online based survey will include a specific scenario and details on~     the scenario represented in image format and a brief description of the patient to aid with~     their analysis of the situation.~   "
40335|NCT02529020|"~     The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece~     require additional research to assess its impact on anaerobic ability and ventilatory~     parameters. This study was aimed at determining the ergogenic acute effects of wearing a~     custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.~   "
40336|NCT02529007|"~     The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of~     a colonoscope improves the numbers of polyps detected during bowel cancer screening~     colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy~     with the cap attached.~   "
40337|NCT02528994|"~     This study will test the effect of short-term, high-dose dietary serine supplementation on~     circulating levels of serine. Individuals with risk factors for type 2 diabetes will be~     recruited into the 2 week study. Effects of dietary serine supplementation on glycemic~     measures will also be explored.~   "
40390|NCT02528305|"~     This pilot study aims to investigate whether 6 weeks of twice weekly High-intensity Interval~     Training (HIT) results in improvements in disease-specific measures, feelings of general~     well-being, physical fitness and cognitive function in patients with non-alcoholic fatty~     liver disease or non-alcoholic steatohepatitis.~   "
40338|NCT02528981|"~     Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in~     Canada. It may be passed from a study participant colonized in the genital tract by GBS to~     their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour~     GBS in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per~     1000 births. The use of intrapartum antibiotics to treat colonized individuals with or~     without risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in~     the past decade. Despite this impressive decline, antibiotic resistance has become a major~     public health concern. Association between intrapartum antibiotic use and ampicillin~     resistance in E. coli isolated from neonates has previously been documented. Furthermore,~     while GBS has remained sensitive to penicillin, 20% are resistant to erythromycin and~     clindamycin, which are alternate drugs for patients allergic to penicillin. Alternative~     approaches are therefore needed to reduce the risk of GBS infection.~      We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus~     reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant~     people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as~     probiotics to treat various conditions. In particular, these two strains have shown to be~     beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study~     design involves recruiting two hundred pregnant people (one hundred in each arm) through~     various midwifery practices in the GTA at the end of their first trimester of pregnancy.~     These individuals will be randomized to receive probiotics or placebo for twelve weeks of~     their pregnancies and will be cultured before delivery to determine their colonization~     status. The capsules with probiotics and placebo will be provided free of charge. The study~     design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal~     swabs are routinely offered at 35-37 weeks of gestation.~   "
40339|NCT02528968|"~     Prospective, interventional study of pharmacokinetic (PK)-focused FVIII dosing discussions~     delivered as part of a patient education package.~      The study will capture severe haemophilia A patient reported outcome measures before and~     after PK-focused dosing discussions, including a standardised patient education package,~     that include personalised PK-guided dosing suggestions from a computational predictive~     device (myPKFiT®). The pragmatic study design recognises the CE marked myPKFiT® device is~     being implemented into routine care nationally and consequently only requires a single~     additional clinic visit for the purpose of consenting.~   "
40340|NCT02528955|"~     In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with~     >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care.~     Postoperative radiochemotherapy is indicated in patients with multiple lymph node~     metastasis, lymph node metastasis with extracapsular spread and or R1/2 resection.~      Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many~     patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia,~     fibrosis, trismus etc.~      The aim of this study is to investigate if depending on primary tumor stage, quality of~     resection ( resection margin) and number of lymph node metastasis and performed neck~     dissection an adapted de-intensified dose- and target volume concept may be performed~     without reducing locoregional-control but with reducing radiotherapy-related side-effects.~   "
40341|NCT02528942|"~     The proposed study is in the field of thoracic radiation oncology where radiation therapy is~     used to treat lung cancer. The primary objective of the early phase clinical trial will be~     to evaluate the safety of performing functional avoidance radiation therapy for lung cancer~     patients using 4D computed tomography (4DCT) ventilation imaging.~   "
40342|NCT02528929|"~     To evaluate the effects of a gluten-free diet in irritable bowel syndrome.~   "
40343|NCT02528916|"~     Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.~     Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of~     patients. Nociceptin levels will be measured pre-operatively and post-operatively in plasma~     levels of patients receiving primary total knee arthroplasty. Nociceptin levels will also be~     measured in synovial fluid levels prior to surgical manipulation.~   "
40344|NCT02528903|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study~     in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of~     MHAB5553A.~   "
40345|NCT02528890|"~     The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth~     Hospital through the years 2006-2013 has been higher compared to the national average. On~     reviewing all the cases of infants with early GBS infection, revealed that some of these~     infants were born to mothers who are not included in any of the high-risk groups that need~     to have prophylactic antibiotic treatment before delivery. Therefore, the question was~     whether pregnant Arab women in the North district of Israel have a higher GBS carrier state~     rate than the general rate in Israel?~   "
40346|NCT02528877|"~     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when~     given together with tacrolimus and sirolimus in preventing acute graft-versus-host disease~     during reduced intensity donor hematopoietic cell transplant in patients with myelofibrosis.~     Sometimes transplanted cells from a donor can attack the normal tissue of the transplant~     patient called graft-versus-host disease. Ruxolitinib phosphate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. It may also reduce~     graft-versus-host disease by reducing inflammation and immune modulation. Giving ruxolitinib~     phosphate together with tacrolimus and sirolimus after transplant may prevent~     graft-versus-host disease.~   "
40347|NCT02528864|"~     The aims of this project are: (1) To establish a research platform in order to integrate~     multiparametric imaging and metabolomics data for uterine malignancy. (2) Identify potential~     surrogate biomarkers for early diagnosis of endometrial cancer by using multiparametric~     magnetic resonance imaging and metabolomics approach. (3) To develop surrogate biomarkers~     for uterine malignancy, in detecting tumor involvement of myometrium, cervix, and lymph~     nodes. The investigators propose a 3-year research project to prospectively collect data~     from 150 female patients 20-80 years old, with clinically diagnosed or suspected to have~     uterine malignancy. An additional control group comprising 30 patients with normal~     endometrial tissue will be enrolled. Robust magnetic resonance (MR) imaging techniques~     including MR spectroscopy (MRS), diffusion-weighted imaging and chemical exchange saturation~     transfer (CEST) imaging will be applied. Biological samples (tissue, blood, urine) will be~     analyzed by detailed metabolomics approach (high-resolution MRS).~   "
40401|NCT02528162|"~     Prospective observational cohort study of women with gestational diabetes (GDM) based on the~     'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is~     to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction~     of women with GDM about the education they receive (given in group or individually). Normal~     routine care is followed and evaluated.~   "
40348|NCT02528851|"~     The aim of this study is to compare the cardiovascular and respiratory effects of higher~     versus equivalent CPAP pressures post-extubation from high endotracheal airway pressures~     (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled~     cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure~     (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on~     conventional ventilation] at time of extubation. Participants will be randomized to higher~     CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or equivalent CPAP group~     (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We~     hypothesize that higher CPAP levels, when compared to equivalent CPAP levels, do not~     adversely impact the cardiorespiratory status when a patient is extubated from high EAP.~   "
40349|NCT02528838|"~     The study is designed as a prospective, non-interventional, observational single arm study.~     Hundred-fifty patients over 18 with stable disease or at least partial response while on~     treatment with lenalidomide will be recruited from approximately 20 haematology/oncology~     sites in the Netherlands. Recruitment will continue until 150 patients have started the~     study. When this target is reached, all patients on lenalidomide will continue to be~     followed until the last patient has been followed for 36 months.~   "
40350|NCT02528825|"~     Smooth emergence is important for patient safety and satisfaction. Coughing during emergence~     is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative~     pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and~     hoarseness are most common complications after extubation 2,3 and closely related to patient~     satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and~     airway injury than using single lumen tube for it has large size5,6. Various technique and~     drugs have been proposed for reducing coughing during extubation including smooth emergence~     1,7-11 and this is closely correlate with reducing sore throat and hoarseness 12. One of the~     proposed technique, the use of short acting opioids are prefered13-15 because it can be~     maintained during emergence with less respiratory depression. Remifentanil is a potent short~     acting opioid and several studies choose remifentanil combined with other anesthetic agents~     1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target~     controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with~     propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for~     smooth DLT extubation.~      The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site~     TCI for preventing cough during extubation of DLT in total TIVA with propofol and~     remifentanil.~   "
40351|NCT02528812|"~     In a randomized control trial and single blinded study, tender spots were identified in 150~     participants` plantar flexor muscles (gastrocnemius or soleus). Then participants were~     randomly assigned to one of five intervention groups (n = 30): 1) heavy rolling massage on~     the calf that exhibited the higher tenderness (Ipsi-R), 2) heavy rolling massage on the~     contralateral calf (Contra-R), 3) light stroking of the skin with roller massager on the~     calf that exhibited the higher tenderness (Sham), 4) manual massage on the calf that~     exhibited the higher tenderness (Ipsi-M) and 5) no intervention (Control). Pain pressure~     threshold (PPT) was measured at 30 seconds and up to 15 minutes post-intervention via a~     pressure algometer.~   "
40352|NCT02528799|"~     A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human~     Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.~   "
40353|NCT02528786|"~     The purpose of this study is to obtain blood samples from up to 14 subjects who previously~     received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to correlate~     genetic markers with clinical outcomes.~   "
40354|NCT02528773|"~     The investigators are conducting a study to learn more about the spread of HIV infection~     within different geographic regions and populations in San Diego County, with the goal of~     demonstrating that early use of HIV treatment can reduce the number of new infections in our~     community. At the study visits, participants will be examined by the study staff and asked~     to donate some blood. Participants will also be asked several questions about themselves,~     their background, behaviors, health, and the general geographic area in which they live. By~     collecting information about antiretroviral treatment choices that are made by study~     participants, the investigators will be better able to measure how effectively HIV treatment~     can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study~     visits will be de-identified and analyzed. Study staff will use the information to better~     understand in which groups of people, and in what areas of San Diego, HIV is spreading most~     quickly. This information will be used to determine how well Antiretroviral Therapy (HIV~     treatment) by certain individuals can control the spread of HIV within the population.~   "
40355|NCT02528760|"~     1. All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be~          screened.~        2. Patients fulfilling criteria for feed intolerance to be included in the study.~        3. Patients to undergo routine biochemical and hematological testing including CBC, KFT,~          LFT, PT/INR, electrolytes baseline and daily along with ABG (Arterial Blood gas)~          analysis.~        4. Patients with ascites to be tested for presence or absence of SBP (Spontaneous~          Bacterial Peritonitis).~        5. Cultures to be sent as based on clinical parameter of the patient.~        6. All correctable causes for intra abdominal hypertension to be corrected including~          electrolyte imbalance, grade III ascites, intra abdominal infection.~        7. Symptoms- Absent bowel sounds (BS)= no BS detected by auscultation.~          Vomiting/regurgitation= any visible regurgitation of gastric contents; Diarrhoea=~          liquid stool > or =3 times/day; Bowel distension= suspected clinically and~          radiologically confirmed; Large gastric residual volume (GRV) of >or =500 ml/24 h on a~          single day or > 200ml at any time of the day.~        8. Per abdomen findings to be checked daily including presence of bowel sounds,~          tenderness, development of abdominal distension, abdominal girth monitoring and~          abdominal pressure monitoring.~        9. Patients who develop feed intolerance will be included.~       10. Feed intolerance to be defined as per study definition (3 out of 5 symptoms).~       11. Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.~       12. Methods for measuring GRV by either gravity drainage by connecting a gastric tube to a~          drainage bag for 10min or by manual aspiration of content using a 50ml syringe.~       13. Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring~          and abdominal girth monitoring to be done (24)~       14. Intra bladder pressure to be measured using Foleys manometer technique (25).~       15. Pressure measured in cm of water to be converted into mm of Hg.~       16. X ray abdomen supine to look for bowel distension, defined as more than 3 cm for small~          bowel and more than 5 cm in large bowel.~       17. Development of intra abdominal hypertension based on intra abdominal pressure.~       18. Patient to be stratified according to the grade of intra-abdominal hypertension.~       19. After correction of all correctable causes, if feed intolerance persists, then patient~          to be randomized by block randomization method into 3 arms, metaclopromide group,~          erythromycin group or placebo group.~       20. Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly~          and gastric residual volume to be noted every 4 hourly.~       21. Response of therapy to be assessed at 24 hours in each arm.~       22. Response to be assessed by resolution of feed intolerance or initiation of entral~          nutrition.~       23. Metoclopromide to be given 10mg iv 8 hourly.~       24. Erythromycin to be given 70mg iv 12 hourly (26).~       25. Placebo arm to receive normal saline in 10ml syring twice daily.~       26. After 24 hours of treatment if symptoms do not resolve than rescue treatment will be~          given to each arm which may include continuation of prokinetics, add on prokinetic,~          flatus tube insertion for bowel decompression, upgradation of antibiotics or search for~          any other cause, as per the patient response.~       27. Therapy to continue for a total duration of 72 hours.~       28. If there is no response at 72 hours, than study stops.~       29. If patient responds to given treatment, study to continue for a total duration of 7~          days.~       30. Assessment to continue in each arm for a maximum period of 7 days.~   "
40356|NCT02528747|"~     This observational, multicenter survey is designed to assess the efficacy of oral~     ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of~     ibandronate in clinical practice will be collected from Hungarian patients.~   "
40357|NCT02528734|"~     Monocentric observational study of needle exsufflation for pneumothorax in the ICU.~   "
40358|NCT02528721|"~     The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode~     BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis~     and post treatment monitoring of H.pylori infection in adult patients and its results will~     be compared to biopsy results.~   "
40359|NCT02528708|"~     In this prospective, single-center, randomized, placebo-controlled, double-blind clinical~     trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate~     following both vaginal delivery and cesarean section complicated by an estimated blood loss~     (EBL) >1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume~     replacement, uterine massage, and uterotonic agents).~   "
40430|NCT02527785|"~     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,~     and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.~   "
40431|NCT02527772|"~     The purpose of this study is to determine that Liposomal Doxorubicin(LD) plus~     Gemcitabine(GEM) is superior to Oxaliplatin（OXA） Plus Fluorouracil/Leucovorin(FOLFOX4) in~     prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular~     Carcinoma.~   "
40360|NCT02528695|"~     The metabolic function of different white adipose tissue depots in the body and its role in~     the development of type 2 diabetes (T2D) remains unclear. Several studies have used fluor-18~     fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) to~     image the metabolic activity of different adipose tissues in lean and obese healthy subjects~     and in patients with T2D with or without euglycaemic hyperinsulinemic clamping, describing~     differences in metabolic activity of visceral adipose tissue (VAT), subcutaneous adipose~     tissue (SAT) and gluteal-femoral adipose tissue (GFAT). Recently, FDG PET/CT showed high~     glucose uptake in VAT and SAT under unintentional hypoglycaemic conditions in a non-diabetic~     patient. Evaluation of potential differences in FDG uptake in white adipose tissue between~     healthy volunteers and T2D patients and between VAT, SAT and GFAT in these subjects under~     hyperinsulinemic hypoglycaemic conditions would be of great value in further exploring the~     pathogenesis of insulin resistance in T2D.~   "
40361|NCT02528682|"~     Allogeneic stem cell transplantation (allo-SCT) is a potent treatment, and sometimes the~     only curative treatment for aggressive hematological malignancies. The therapeutic efficacy~     is attributed to the graft-versus-tumor (GVT) response, during which donor-derived CD8+ T~     cells become activated by recipient minor histocompatibility antigens (MiHA) presented on~     dendritic cells (DC). Consequently, these alloreactive donor T cells clonally expand,~     acquire effector functions and kill MiHA-positive malignant cells. However, in a substantial~     number of patients persistence and recurrence of malignant disease is observed, indicating~     that insufficient GVT immunity is induced. This is reflected by our observation that not all~     patients develop a productive CD8+ T cell response towards MiHA mismatched between the~     recipient and donor. We found that the PD-1/PD-L1 co-inhibitory pathway is involved in~     dampening MiHA-specific CD8+ T cell expansion and function post-transplantation. Therefore,~     a promising strategy to induce or boost GVT immune responses is pre-emptive or therapeutic~     vaccination with ex vivo-generated donor DCs loaded with MiHA that are exclusively expressed~     by recipient hematopoietic cells and their malignant counterparts. In contrast to~     pre-emptive donor lymphocyte infusion (DLI) with polyclonal donor T cells, this MiHA-DC~     vaccination approach has less risk of inducing graft-versus-host disease (GVHD) and the~     potency to induce more efficient GVT-associated T cell immunity. In addition, the potency of~     this DC vaccine will be further enhanced by interference with the PD-1/PD-L1 co-inhibitory~     pathway, using siRNA mediated PD-L1/PD-L2 silencing.~   "
40362|NCT02528669|"~     The purpose of this study is to create a platform that accurately measures and reports~     patient physical activity before a procedure, during the hospital stay, and after discharge~     from the hospital.~   "
40363|NCT02528656|"~     The physiological assessment in non-operative treatment on chest wall deformities, are still~     unclear today. These functional benefits outweigh the aesthetic benefits associated with~     anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic,~     have never been evaluated.~      Assessment of Effects on parasympathetic activity of the autonomic nervous system, global~     health criterion measured by noninvasive methods.~      Anatomic evaluation, between the initial and final assessment by objective measures 1) of~     the chest wall by MRI, and 2) of the heart by echocardiography.~      Noninvasive physiological assessment at rest and during exercise in respiratory function~     exploration flows and volumes, cardiac function by flow measurement, and overall metabolic~     function test effort (VO2max). Subjective assessment of functional gain between the initial~     and final balance sheet, based on EVA scales, valued by patients, parents and doctors.~   "
40364|NCT02528643|"~     The purpose of the study is to evaluate the efficacy of enzalutamide in subjects with~     advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).~      This study will also evaluate the safety of enzalutamide; pharmacokinetics of enzalutamide~     and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as~     compared to placebo in subjects with advanced HCC.~   "
40365|NCT02528630|"~     Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population~     over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and~     carpometacarpal joints may have varying degrees of deformity associated with pain, decreased~     of grip and pinch strength, decreased range of motion and functional impairment. Systematic~     reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA,~     however for hand OA exercise is still used based on recommendations based on clinical~     experience and low quality studies, not allowing a conclusion about the effects of exercise~     in pain, function and strength in hand OA patients.~      Objective: assess the effectiveness of progressive resistance strength training program on~     pain, function and strength in hand OA patients.~      Methods: diagnostic of hand OA according to American College of Rheumatology of at least~     1year, age over 55 years, both genders, pain in IF joints between 3-8 cm on a 10-cm~     numerical pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized~     into exercise group (EG) and control group (CG). Both groups performed a session regarding~     joint protection and energy conservation before randomization. The EG performed a~     progressive resistance strength training program for intrinsic muscles of the hand for 12~     weeks. The outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index~     and Cochin Hand Functional Scale for hand function; grip and pinch strengthening using the~     Hydraulic Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment~     using a Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12~     weeks after treatment baseline.~   "
40366|NCT02528617|"~     The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone~     development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural~     history and neurological status of children with Type 3 Gaucher Disease will be studied.~   "
40367|NCT02528604|"~     Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker~     implantation with AV node ablation for patients over 65 years of age with persistent Atrial~     Fibrillation.~   "
40454|NCT02527473|"~     In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will~     assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS)~     education program through a simulation experiment.~      This study aims to determine whether the new DA-BLS program for possible home bystanders is~     associated with improved CPR quality. We expect home bystanders who were trained with new~     DA-BLS education program to show better compliance with CPR instructions given by dispatcher~     via telephone along with improved CPR quality.~   "
40368|NCT02528591|"~     The renal transplant patient is at high cardiovascular risk compared to the general~     population. The cardiovascular mortality represents one of the most important causes of late~     graft loss. Cardiovascular risk prediction tools applied to the general population, however,~     are caught failing on the population of kidney transplant and tend to underestimate the~     actual risk.~      Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is~     directly related to the target organ (heart, kidney, brain). Central blood pressure could be~     a cardiovascular risk factor more robust and powerful than brachial blood pressure.~      Central blood pressure may in part explain the increased risk of cardiovascular disease in~     the population of kidney transplant patients. A cohort of 250 kidney transplant patients~     will be constituted with a measure of concomitant central hemodynamic monitoring to the~     annual review will be conducted. The main objective of this study is to describe the central~     blood pressure measured by oscillometric method in renal transplanted population.~   "
40369|NCT02528578|"~     The objective of the study is to evaluate in healthy volunteers, the influence of empathy on~     pain perception.~      It is widely accepted in the clinical management that the feeling of listening to the~     patients' pain would have a favorable influence on the pain, and conversely, the lack of~     listening would be aggravating.~      In this study, the volunteer will receive painful thermal stimuli in empathetic context (l,~     empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or~     minimize the suffering of the voluntary and the other or the contrary, the subject will~     receive empathy.~      The first part of the project is to verify that the pain is influenced by the empathetic~     context. The second part will be conducted functional MRI, which should isolate the brain~     regions affected by other people's empathy for pain.~   "
40370|NCT02528565|"~     The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in~     patients after failed RYGB.~   "
40371|NCT02528552|"~     This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy~     of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to~     SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a~     usability study to assess subject ability to self-assess hair loss and understanding use of~     the device.~   "
40372|NCT02528539|"~     Introduction: Breast cancer women who are treated with axillary node dissection are at~     increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and~     the risk can significantly increase with chemotherapy and radiation therapy~      Objectives:~        1. To evaluate the feasibility and effectiveness of implementing the integrative therapy~          program (ITP) intervention. ITP consists of self-management education in conjunction~          with acupuncture.~        2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain,~          and early detection and management of lymphedema.~      Design: the exploratory study aims to evaluate the feasibility and benefits of the~     integrative therapy program (ITP) intervention post-operatively for 18 months.~      Subjects: Women with breast cancer treated with axillary node dissection with normal~     baseline pre-operative bioimpedance (L-dex U400) score.~      Sample size: 30 subjects~   "
40373|NCT02528526|"~     The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe~     and tolerated in patients with primary and secondary hepato-pancreato-biliary and~     gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At~     level of MTD, additional patients will be included aimed for assessing the efficacy profile~     in these neoplasia entities.~   "
40374|NCT02528513|"~     The purpose of this study was to evaluate effects, safety and cost of midazolam used alone~     or sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in~     critically ill, mechanically ventilated patients.~   "
40375|NCT02528500|"~     This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal~     Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the~     Visceral Branch Vessels.~   "
40376|NCT02528487|"~     The present study aims to assess the prevalence and impact of comorbid psychiatric disorders~     among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary~     rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on~     exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the~     processes by which these psychiatric disorders may impact on these patient behaviours.~   "
40377|NCT02528474|"~     Drug-coated balloon technology (DCB) has recently attracted considerable interest as a~     promising alternative treatment option, particularly in the setting of in-stent restenosis~     (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents~     (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be~     compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.~   "
40378|NCT02528461|"~     The purpose of the study is to investigate how the liver is affected with regard to~     inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.~      In order to examine how the liver heals, we want to use blood samples to check for the~     occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent~     fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of~     ultrasound examination) and also preferably with extraction of a small tissue sample. We~     want to examine how the liver function as inflammation and scar tissue decrease, especially~     concerning the liver's ability to produce proteins. Furthermore, we want to examine with a~     gastroscopy, if the circulation of blood in the liver is improved after successful treatment~     with the expected result that potential varicose veins in the esophagus vanish.~   "
40379|NCT02528448|"~     The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline~     versus Plasma-Lytein in patients having primary hip replacement surgery. The outcome is~     found measuring bio markers, vasoactive hormones and salt regulation. And to measure~     syndecan as a marker for glycocalyx degradation.~   "
40467|NCT02527304|"~     This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT)~     in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a~     specialized radiation therapy that delivers a single, high dose of radiation directly to the~     tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT~     uses information gathered during treatment to inform, guide, and alter future radiation~     treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive~     staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.~   "
40381|NCT02528422|"~     Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of~     Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors~     are detected in the distal tubules in mice and animal studies have shown that Ghrelin~     increases the absorption of sodium in the renal tubules. Ghrelin infusion directly into the~     renal artery of rats increased sodium reabsorption in the distal nephron, presumably via the~     epithelial sodium channels (ENaC).~      The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular~     transport of sodium and water in different nephron segments and central and peripheral blood~     pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.~   "
40382|NCT02528409|"~     The aim of the present study is to examine the efficacy and safety of vortioxetine vs~     placebo in adults with moderate to severe Binge eating disorder, as indicated by at least 3~     binge eating days per week for the 2 weeks before the baseline visit.~   "
40383|NCT02528396|"~     This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an~     individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes~     mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro~     compared to Humalog®. The assessments will be conducted before and after a period of~     multiple daily dose administrations for 14 days. The meal tolerance test will be performed~     on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating~     Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when~     injected at various injection meal intervals (-15min, 0 minutes, +15 minutes).~      Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin~     lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of~     injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will~     be performed during the 14 day treatment periods.~   "
40384|NCT02528383|"~     Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as~     vaginal dryness and urinary discomfort. The purpose of this research study is to see the~     benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal~     symptoms and health. The investigators also want to monitor whether the bones might be~     impacted by estrogen or its absence. If there is an effect on bones, it means that some~     estrogen may be absorbed from the tablet to affect other places in the body. The~     investigators are hoping to prove this is not the case. The investigators will also be~     measuring the quality of life of women participating in the study.~   "
40385|NCT02528370|"~     Observational non-randomized study with an intervention cohort from Hospital~     Galdakao-Usansolo with 119 patients and a control cohort from Hospital Cruces with 78~     patients. The inclusion criteria were: being hospital admitted at least twice in the~     previous year or at least three times in the 2 previous years. The cohorts were follow-up~     for 2 years. Several clinical measurements like pulmonary function, exercise capacity,~     health related quality of life, limitation in daily life activities and anxiety and~     depression were recorded in both cohorts. Telemonitoring and an organized education program~     were only and exclusively applied in the intervention cohort.~   "
40386|NCT02528357|"~     This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed~     to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and~     preliminary clinical activity of GSK3174998 administered intravenously to subjects with~     selected advanced or recurrent solid tumors.~      This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy~     (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with~     additional therapies.~      The study will be conducted in 2 parts, each part consisting of a dose-escalation phase~     followed by a cohort expansion phase. Part 1 will evaluate GSK3174998 monotherapy, while~     Part 2 will evaluate GSK3174998 in combination with pembrolizumab.~      GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of~     GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic~     activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be~     evaluated with fixed doses of pembrolizumab.~      The study will enroll up to approximately 264 subjects with different tumor types~     (approximately 144 subjects in Parts 1A and 2A [dose escalation]; approximately 120 subjects~     in Parts 1B and 2B [cohort expansion]). The maximum duration of treatment with GSK3174998~     plus or minus pembrolizumab will be 2 years or 35 cycles, whichever comes first. The~     follow-up period for safety assessments will be a minimum of 3 months from the date of the~     last dose. The post-treatment follow-up period includes disease assessments every 12 weeks.~   "
40387|NCT02528344|"~     The overall objective is to determine whether High Intensity Interval Training (HIIT) has~     potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By~     reducing inflammation and modifying immune function HIIT may offer a substantial paradigm~     shift in RA care, especially in older persons with RA who experience aging~     related-immunesenescence, increased systemic inflammation and greater physical inactivity~     than young persons. Prior to embarking on a large scale trial of HIIT-induced disease~     modification, this pilot study aims to demonstrate that HIIT can produce measurable~     responses in disease activity scores and peak VO2in persons undergoing routine pharmacologic~     treatment for RA.~   "
40388|NCT02528331|"~     The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS)~     delivered simultaneously with elements of cognitive behavioral therapy/exposure-response~     prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with~     obsessive-compulsive disorder (OCD). This is an open label study that involves standard of~     care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will~     compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment~     to quantify clinical improvement. The side effects from TMS include, but are not limited to,~     headache, seizure, and general pain. CBT has minimal side effects other than mental~     discomfort during the exposure sessions. For safety concerns, pregnant women and subjects~     with seizure-related history will be excluded as well as other indicated conditions in the~     details protocol.~   "
40389|NCT02528318|"~     The primary objective of this study is to evaluate the safety and tolerability of~     lucinactant for inhalation, administered as an aerosolized dose in up to four escalating~     doses to preterm neonates 26 to 28 weeks gestational age who are receiving nasal continuous~     positive airway pressure (nCPAP) for respiratory distress syndrome (RDS) compared to~     neonates receiving nCPAP alone.~   "
40391|NCT02528292|"~     This study will be an open label observational prospective study assessing the clinical~     efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific~     regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid~     arthritis.~      Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the~     UK. It affects approximately 1% of adults and causes considerable morbidity, substantially~     reduces quality of life and has a significant mortality. It results in large direct medical~     costs as well as extensive indirect social costs. Despite the significant therapeutic~     progress following the introduction of antiTNFα, a cure for RA is still elusive. At present~     the reasons for the variation in clinical response are not known. The main aim of this study~     is to test the hypothesis that there are distinct molecular and cellular phenotypes present~     within the synovial tissue that define specific disease subsets and provide characteristic~     prognostic implications. In particular, the aim is to assess the relationship between the~     presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and~     response to antiTNFα therapy.~   "
40392|NCT02528279|"~     Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms~     are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax.~      Although the interest in research on malaria has increased during the last years, yet little~     research is conducted on the neglected malaria species P. ovale and P. malariae. P. ovale~     being first described in 1922, it still remains unclear whether it displays dormant~     pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed~     drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate~     dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread~     in Central Africa, it is important to explore whether additional intake of liver-active~     medication is really needed and on this account further research to investigating new~     treatment options with liver stage activity should be conducted.~      While, due to widespread resistance, treatment recommendations for P. falciparum and mixed~     infections have switched from chloroquine to the safer applicable artemisinin-based~     combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest~     chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further~     studies assessing alternative treatment options are largely missing.~      Summing up the current situation for both topics shows the need for further research.~     Therefore this study aims to assess the evidence and characterize the frequency of relapses~     in P. ovale infections with respect to differences between its subspecies as well as the~     effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed~     infections.~   "
40393|NCT02528266|"~     This study is conducted to clinically assess safety and performance of the Polyganics nerve~     capping device for the treatment of symptomatic neuroma. There is sufficient clinical~     experience with regard to the safety of the commercially available nerve guide, NEUROLAC®.~     This new nerve capping device is identical in material and manufacturing. The exception is~     in design, where NEUROLAC® has two open ends, the nerve capping device has one closed~     (sealed) end. This study will be conducted to obtain data on the clinical performance of the~     capping device's ability to isolate the nerve end, resulting in a reduction of pain of~     experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic~     neuroma.~   "
40394|NCT02528253|"~     This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered~     by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective~     of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to~     placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the~     long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the~     treatment of chronic low back pain. In addition, the study will evaluate the effectiveness~     and long term safety profile of tanezumab treatment for chronic low back pain compared to~     tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic~     low back pain.~   "
40395|NCT02528240|"~     This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during~     endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone~     healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone~     healing will be studied. The trial design is an open randomized controlled clinical trial~     with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF~     (experimental group), the other half without (control group). The control and experimental~     group will be divided in 2 subsequent groups: half of the participants will receive an~     occlusive membrane during EMS, the other half not.~   "
40396|NCT02528227|"~     The purpose of this study is to adminster one of two education programs to parents of~     preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.~   "
40397|NCT02528214|"~     Primary Objective:~      To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of~     maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of dupilumab.~        -  To evaluate the effect of dupilumab in improving patient-reported outcomes.~        -  To evaluate dupilumab systemic exposure and the incidence of treatment-emergent~          antidrug antibodies.~   "
40398|NCT02528201|"~     A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400~     milligrams (mg) once daily compared to diclofenac three times daily in the treatment of~     Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a~     prior 6 week trial.~   "
40399|NCT02528188|"~     The purpose of this study is to compare the long-term joint safety and efficacy (pain~     relief) of the investigational study drug, tanezumab compared to non-steroidal anti~     inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.~   "
40400|NCT02528175|"~     This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided~     focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination~     with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer.~     Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited~     for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral~     chemotherapy.~   "
45652|NCT02459457|"~     The purpose of this study is to determined the best scheme in paclitaxel and~     cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with~     radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.~   "
40402|NCT02528149|"~     Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose~     innate or acquired character is still unknown. This segmental non atheromatous injury, leads~     to stenosis of the arteries of small and medium caliber. Renal arteries are the most~     commonly affected with 60-75% of total fibrodysplasia. Three histological subtypes have been~     described: intimal, medial and peri-medial. They are not mutually exclusive and can be~     observed in the same patient.~      This is a rare blood disease, occurring in children and young adults. In this young~     population with long life expectancy, these aneurysmal lesion are associated with 10% risk~     of rupture. To date, no data have shown in the literature that FMD is link to genetic~     causes, or if there is specific histopathologic lesions for non-atherosclerotic renal artery~     aneurysms.~      To answer these questions, Cardiovascular Surgery Unit of the University Hospital of~     Saint-Etienne, French national reference center for renal artery surgery, in association~     with the Reference Center for Rare Vascular Disease in Paris, designed the first study for~     pathological and genetic characteristics of dysplastic renal artery aneurysms in young~     patients.~   "
40403|NCT02528136|"~     Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.~   "
40404|NCT02528123|"~     The purpose of this study is to validate the safety and effectiveness of treating myopia~     (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with~     the VisuMax femtosecond laser.~   "
40405|NCT02528110|"~     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal~     metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial~     is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of~     overall survival.~   "
40406|NCT02528097|"~     Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of~     end-stage liver disease with a mortality of up to 10% primarily due to the development of~     kidney failure. Current standard practice is to treat this infection with broad spectrum~     antibiotics and salt-poor albumin administration on day one and three of treatment. In this~     study the investigators test the hypothesis that the administration of a second dose of~     albumin at 48 hours only to patients with renal insufficiency is as effective at preventing~     kidney failure as administering the second dose to all patients at 72 hours. In addition, a~     kidney function determined approach to albumin dosing may lead to substantial cost and~     resource saving from decreased albumin use without compromising treatment efficacy.~   "
40407|NCT02528084|"~     To determine if patients who undergo a 6-week online yoga exercise treatment differ from~     those who undergo a 6-week online standard exercise intervention and patients who do not~     undergo any treatment (the control).~   "
40408|NCT02528071|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves~     respiratory muscles and can lead at short term to respiratory failure. The occurrence of~     respiratory failure is associated with morbidity and an increased mortality. To date,~     respiratory muscle weakness is predicted from the reduction of vital capacity, maximal~     inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive~     value of these indices is low.~      The investigators hypothesize that an endurance test of diaphragmatic work would be more~     sensitive to respiratory muscle involvement than maximal respiratory force.~      Consequently, the investigators assessed diaphragmatic performance through an isocapnic~     hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the~     occurrence of respiratory failure. The investigators make the hypothesis that IHT will be~     altered earlier than maximal inspiratory force~   "
40409|NCT02528058|"~     The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular~     retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent~     vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to~     evaluate ultrastructure with electron microscopy.~   "
40410|NCT02528045|"~     The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic~     traction maculopathy who received viterctomy including internal limiting membrane peeling~     and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length,~     retinal reattachment and macular hole closure, the shape of staphyloma determined by optical~     coherence tomography and 3-dimensional magnetic resonance imaging were assessed.~   "
40411|NCT02528032|"~     Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with~     biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT~     restores contraction coordination between different regions of the left ventricle, which~     yields a significant improvement in LV systolic function, symptoms, exercise tolerance and~     quality of life. In the longer term, treatment with resynchronization induces a reverse~     remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization~     for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the~     benefit, some (up to 40% depending on the response criteria of CRT) do not experience~     significant improvement (nonresponders). Echocardiography and imaging have not so far~     demonstrated their added value to optimize delivery of CRT. Monocentric promising work on~     limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering~     CRT evolves and new probes with four poles stimulation of the left ventricle are now used.~     The objective of this research is to validate new sequences of ultrasound processing~     estimating the CRT. These tools are based on usual echocardiographic examination of patients~   "
40412|NCT02528019|"~     Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2)~     has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors~     or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their~     glucose-lowering effects remains unknown.~   "
40413|NCT02528006|"~     For adductor spasmodic dysphonia, there is a need for establishing a new therapy under the~     present circumstance where no standard therapy has been established yet and existing~     therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty~     using titanium bridges will expand the therapeutic options available for adductor spasmodic~     dysphonia and establishment of a standard therapy.~   "
40554|NCT02526173|"~     The investigators will examine the beneficial impacts of applying of dHACM on the preserved~     neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted~     laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing~     and reduction of inflammation at the operative site and thus an acceleration of return of~     potency regulating cavernosal nerves.~   "
40414|NCT02527993|"~     Obesity is increasing worldwide and consequently the need for efficient treatment~     opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed~     bariatric procedures used in the treatment of severe obesity. The surgery results in~     significant and sustained weight loss and has a beneficial effect on blood glucose~     regulation.~      However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia~     years after the operation, with symptoms varying from mild dizziness to confusion, loss of~     consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to~     an oral glucose load are believed to play a role in the syndrome, which is not yet fully~     understood. There are no current treatment guidelines beside dietary recommendations.~      The purpose of this study is to compare different pharmacological treatments on daily blood~     glucose variations as well as postprandial hormonal and autonomous changes in subjects with~     symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.~   "
40415|NCT02527980|"~     The proposed research will provide in-depth, longitudinal data, based on real-time reports,~     which will address key priorities for the FDA including, increased understanding of the~     relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions~     in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those~     attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.~   "
40416|NCT02527967|"~     Although there is evidence for reducing complication rate and improving recovery after the~     implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery,~     most published papers include patients undergoing open resections. The aim was to analyse~     factors affecting recovery and length of stay (LOS) in patients after laparoscopic~     colorectal surgery for cancer combined with ERAS protocol.~   "
40417|NCT02527954|"~     In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and~     Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS),~     the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without~     microdeletions who undergo assisted reproduction in their clinics.~   "
40418|NCT02527941|"~     A non-randomized, interventional, longitudinal clinical study to quantify the impact of~     bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.~   "
40419|NCT02527928|"~     Invasive fungal infections (IFIs) are complications that happen in the hospital, usually in~     patients hospitalized for long periods in intensive care units (ICU) after invasive~     procedures, and in specific populations, such as cancer patients. The aim of this study is~     to determine the direct and indirect hospital costs with different formulations of~     amphotericin B (deoxycholate, lipid complex and liposomal) in different public and private~     hospitals in the city of Curitiba, Paraná, Brazil.~   "
40420|NCT02527915|"~     The purpose of this study is to assess whether electronic consultations between primary care~     providers and psychiatrists affects mental health services delivered in primary care~     settings.~   "
40421|NCT02527902|"~     The estimation of the cardiovascular risk in the general population must take into account~     small renal disturbances, as the microalbuminuria. Conversely certain parameters of the~     cardiovascular risk influence the evolution of renal diseases, for example the arterial high~     blood pressure.~      The measure of the activity of the autonomous nervous system, and especially the~     quantification of its variability, is a means to estimate the cardiovascular risk. The~     investigators formulate the hypothesis that the variability of the autonomous nervous system~     is an additional clinical element for the evaluation of the evolutionary risk of renal~     diseases.~      The aim of this study is to compare the variability of the autonomous nervous system during~     the various evolutionary stages of the renal disease.~      The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined~     glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the~     renal mesangium (at list 1+) by immunofluorescence.~   "
40422|NCT02527889|"~     The purpose of the study is to evaluate the effect of resistive exercise on forearm blood~     flow and tissue oxygenation among breast cancer survivors with or at risk for breast~     cancer-related lymphoedema (BCRL).~   "
40423|NCT02527876|"~     The purpose of this study is to evaluate how physical activity levels change in young adults~     when they start a specific exercise program.~   "
40424|NCT02527863|"~     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and~     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which~     stimulates V1-receptors in the vascular bed and may change both central and brachial~     hemodynamics and plasma concentration of vasoactive hormones.~      The purpose of the study is to measure the effects of tolvaptan on renal handling of water~     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric~     oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal~     dominant polycystic kidney disease.~   "
40425|NCT02527850|"~     Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim~     of this study is to investigated the effect of B-cure laser on muscle performance and~     recovery after intense exercise.~   "
40426|NCT02527837|"~     The purpose of this study is to investigate how the effect of infused sodium nitrite differs~     in hypertensives compared to healthy age and sex matched controls. The effects on renal~     handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive~     hormones, peripheral (brachial) and central blood pressure will be evaluated.~   "
40427|NCT02527824|"~     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,~     and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.~   "
40428|NCT02527811|"~     1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary~          insufficiency and safety in pediatric patients undergoing scheduled CPB open heart~          surgery to treat Complex Congenital Heart Disease~        2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic~          instability as well as other post-operative organ recuperation and its impact on~          hospital stay & cost~   "
40429|NCT02527798|"~     This study will describe the safety of furosemide in premature infants at risk of~     bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics~     (PK) of furosemide.~      Funding Source--FDA Office of Orphan Product Development~   "
40432|NCT02527759|"~     The purpose of this study is to examine the relative predictive ability of the derived~     monitoring instrument to determine post discharge instability and 30-day outcomes in~     patients discharged with HF. The primary hypothesis is that variables in the monitoring~     instrument, individually and combined, identify risk for 30-day outcomes. Clinical~     indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart~     rate, blood pressure, mental condition, medication adherence, and overall well-being will be~     reported by participants on a daily basis and considered indicators for 30-day outcomes of~     stability, re-hospitalization, or mortality.~   "
40433|NCT02527746|"~     A Phase I, dose escalation study to evaluation the safety and~     pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up~     to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were~     assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.~   "
40434|NCT02527733|"~     The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal~     vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully~     investigated. The purpose of this study is to compare the changes in retinal sensitivity~     after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation~     in eyes with BRVO.~   "
40435|NCT02527720|"~     The investigators plan to establish the efficacy of a novel breathing-based mindfulness~     training (BBMT, a much simplified, easy-to-use version of standard MM) for problem drinking,~     and test whether impulsivity mediates this effect among a sample of student problem drinkers~     (i.e., > 8 on AUDIT, the problem drinking Screening Test). The specific aims of this pilot~     study are as follows:~        1. to modify and further develop the easy-to-use BBMT program for directly targeting~          impulsivity to produce an indirect reduction in problem drinking among college~          students;~        2. to investigate the feasibility and preliminary efficacy of applying BBMT for reducing~          problem drinking with a pilot randomized controlled trial (RCT);~        3. to examine changes in impulsivity, as measured by both behavioral and self-report~          assessments, as one of the possible mediators in the effect of BBMT on problem~          drinking, with control for changes in perceived stress and anxiety.~   "
40436|NCT02527707|"~     A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamic activity of titrating-dose lonafarnib in combination with ritonavir in~     patients chronically infected with hepatitis delta virus~   "
40437|NCT02527694|"~     This study aims to compare the quality of emergency medical services cardiopulmonary~     resuscitation between flexible stretcher and standard stretcher during ambulance transport~     to hospital among out-of-hospital cardiac arrest patients.~   "
40438|NCT02527681|"~     The primary objective is to characterize the pharmacokinetics of single doses of~     ceftobiprole in neonates and infants aged ≤ 3 months. The secondary objective is to evaluate~     safety and tolerability of ceftobiprole in neonates and infants aged ≤ 3 months.~   "
40439|NCT02527668|"~     Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score~     below pharmacologic treatment indication have limited treatment options in the prevention of~     osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side~     effects of bisphosphonate treatment among young postmenopausal women, and hormone~     replacement therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D~     improved several muscle related function in this target population within 4 months of~     treatment, which can help to prevent falls and associated bone fractures. Thus the main aim~     of this study is to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves~     muscle function (lower extremity test battery) compared with (1) placebo and compared with~     (2) 3200 Vitamin D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory~     objective of this study, the investigators will compare the beforementioned doses on muscle~     strength and the quality of the bones, beside muscle mass, body composition and systolic and~     diastolic blood pressure measurements.~   "
40440|NCT02527655|"~     The Men on the Move Study is a randomized, controlled, feasibility study designed to address~     the health problem of physical inactivity in older men.~   "
40441|NCT02527642|"~     This is a randomized, controlled, single-center study in otherwise healthy infertile female~     subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will~     be among those patients who have been diagnosed with infertility and are planning to undergo~     IVF at the centers where this study is being performed. The patients will have undergone the~     usual informed consent procedure at the center.~   "
40442|NCT02527629|"~     Evaluation of decellularized human heart valves for aortic heart valve replacement in~     comparison to current valve substitutes.~      Safety endpoints include cardiovascular adverse events, time to re-operation,~     re-intervention and explantation.~      Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.~   "
40443|NCT02527616|"~     This is a single-blinded, randomised, crossover investigation comparing the investigational~     device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV)~     infusion method used for obtaining FFR measurements. All subjects requiring on a clinical~     basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be~     eligible to take part in the investigation.~   "
40444|NCT02527603|"~     To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for~     anterior shoulder dislocation and the Spaso method performed by a physician.~   "
40445|NCT02527590|"~     The stimuli used in the evoked potentials are electrical or laser. They are started and~     synchronized with the collection of the EEG by signals TTL (transistor-transistor logic).~     Investigators propose to validate a pneumatic stimulator delivering the compressed air sync~     with the EEG. It has two advantages over existing stimuli: Is capable of inducing in~     patients an allodynic response, excessive, painful, in response to a stimulation painless~     rarely obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a~     means to study allodynic evoked potentials unknown to date.~      It must be possible with a single stimulator to explore non-painful sensations and allodynic~     sensation , compare them with one device. The differences are the abnormal responses. This~     validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2.~     allodynic (only in patients). The study therefore provides for the registration 100~     potential for each of these two modalities in patients and only for the painless pneumatic~     modality in volunteers.~   "
40446|NCT02527577|"~     The indications liver cancer surgery currently booming due to the increase in surgical~     techniques and instruments for a more secure resection of liver tissue with a significant~     reduction in bleeding or surgical complications. This allowed to expand surgical indications~     in the most fragile patients so assuming optimized anesthetic care.~      So far, the technique of analgesia reference to this surgery remains administration of~     morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is~     against-indicated because of induced bleeding disorders by surgery.~      Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the~     abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective~     anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging~     surgical approach represent a significant share of post operative pain.~      This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.~   "
40447|NCT02527564|"~     The purpose of this study is to evaluate the efficacy of suvorexant, added to existing~     medications, for treatment-resistant insomnia in individuals with bipolar disorder. The~     investigators hypothesize that participants receiving suvorexant for one week will~     experience significantly greater improvement in sleep duration compared to participants~     receiving placebo.~   "
40448|NCT02527551|"~     Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown~     etiology, characterized by generalized body pain, hyperalgesia and other functional and~     emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might~     be severe by its physical and psychological consequences. The etiology of FMS remains~     unknown but recent studies suggest a disorder of central pain modulation, neurotransmitters,~     sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues.~     Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been~     reported, inducing muscle weakness and local biochemical changes that participate to pain~     hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating~     pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are~     included in chronic pain management recommendations.~      Massages are recognized as haptic when the hands of the practitioner move on the skin of the~     patient; haptic massage is superficial if the pressure applied on the skin is similar to the~     weight of the hand and it's a deep haptic massage when the pressure applied is over the~     weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are~     largely used for athlete to improve muscle recovery and treat tendinitis. All massages~     evaluate in FMS are superficial haptic massage; they are recognized as efficient on pain,~     anxiety and depression if they are performed at least on 5 weeks but these effects are~     transient et remain to be optimized. The efficacy of deep haptic massage has not been~     evaluated in pathological conditions. The investigators hypothesize that, in FMS patients,~     deep intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber~     fibers A lemniscal conveyed by the way that bypass chronic pain information carried by the C~     fibers of the extra-lemniscal pathway: this is the Gate Control theory for inhibiting pain~     information.~   "
40449|NCT02527538|"~     The beach chair position for shoulder operation induces hypotension during general~     anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia.~     Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth~     variability may predict the hypotension during beach chair position.~   "
40450|NCT02527525|"~     The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease~     management guidelines offered by the ADA and other diabetes care organizations place a high~     burden of responsibility onto these children's parents and caregivers to check blood sugar,~     administer insulin, and monitor diet and physical activity to maintain tight glycemic~     control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is~     unpredictable, their T1D is difficult to control, parenting stress is elevated, and~     caregivers are strained by normal child caretaking routines. T1D education and support tends~     to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid~     knowledge and skill acquisition on the part of parents. Not all families respond equally~     well to this teaching model, and many need more guided practice, problem-solving assistance,~     and behavioral supports than can be offered in a one-size-fits-all patient education~     approach. Our research will attempt to better meet the needs of individual families through~     a clinical behavioral stepped care intervention for T1D in parents of young children by~     using real-time glycemic control and [parental depression indices] to intensify management~     support when indicated. Primary caregivers of young children (<6 years) newly diagnosed with~     T1D will be randomized to either a 3-step stepped care (treatment) or usual care~     (comparison) condition. Stepped care components include: T1D management support delivered by~     trained lay parent consultants (Step 1), T1D parenting strategies and mealtime behavior~     management delivered by bachelor's level behavioral assistants (Step 2), and individualized~     diabetes education/management planning with a certified diabetes nurse educator and~     [consultation with a diabetes team clinical psychologist] (Step 3). Biomedical and~     psychosocial measurements (including A1c, depressive symptoms, mealtime behavior, parenting~     stress, quality of life) will occur at baseline and 3-month intervals for up to 15 months~     post-diagnosis. The results of this work will ultimately lead to a more practical approach~     to T1D education and management that can be translated more easily into a variety of~     clinical practice settings to support young children's T1D management.~   "
40451|NCT02527512|"~     This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal~     patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of~     povidone-iodine and normal saline irrigation at reducing bacterial contamination of the~     surgical wound will be measured by collecting cultures before and after irrigation.~   "
40452|NCT02527499|"~     The four purposes of this study are: 1) to examine the feasibility of combining modified~     ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in~     toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to~     have more manual explorations and social interactions with ROCBT through observation and~     wrist-worn accelerometers; 3) to determine the critical factors of using the modified~     ride-on toy car on family perceptions and participation.~      Independent mobility is believed to be essential for perceptual-motor, cognition, language~     and social skill development. It is important to increase independent mobility in toddlers~     with disabilities and further enhance their development, especially socialization. Assistive~     and power mobility devices allow toddlers with disabilities to move independently within~     their environment and may increase the opportunities to explore and interact with people and~     environment. However, issues to consider before prescribing an assistive device include~     factors such as age, accessibly to community environments, cost, and social acceptance of~     the device and the adaptability of the device to growth. To address these limitations and~     meet toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a~     novel application. Study has demonstrated the use of toy cars enhanced a child's motivation,~     socialization and family participation. This study is further to combine the use of~     customized, modified ride-on toy cars with bimanual training, to enhance the independent~     mobility, manual exploration and socialization through low-cost, family-centered approach.~     It will also improve family's understanding of children's capabilities, which improve their~     development.~      Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed~     as motor delay (>1.5 sd). They will be randomly assigned to one of the following three~     groups: ROCBT treatment group, early mobility training group and regular therapy group. The~     whole study duration will be 18 weeks, including 9-week intervention and 9-week follow-up;~     the total amount of treatment will be equal for two groups. Standardized assessments are~     provided for a total of three times during the study, including the time before and after~     the intervention and in the end of the follow-up phase. The ROCBT and early mobility~     training programs will be administered by the therapist and include 120 minutes/per session,~     2 sessions/per week. The research team will visit the hospital once/per week to provide 60~     minutes videotaping and wearing wrist-worn accelerometers. The regular therapy group will~     continue their regular therapy without any additional car driving training. The research~     team will visit them once/per week for the assessments. The assessments include standardized~     measurements and behavior coding from the videotapes and accelerometers. The findings of~     this study will help to understand the feasibility and effectiveness of combining the~     low-tech modified ride-on cars with bimanual training on advancing children's mobility and~     socialization. They can be used in the clinic or school and are a low cost alternative or~     addition to other mobility devices. They may provide a novel therapeutic tool to improve~     mobility, socialization, family participation and development.~   "
40453|NCT02527486|"~     This is a multicenter, prospective observational cohort study, in which patients with~     chronic airway diseases including chronic obstructive pulmonary disease(COPD), asthma,~     asthma-COPD overlap syndrome (ACOS) will be recruited.~   "
40455|NCT02527460|"~     Background:~      HAND is HIV-associated neurocognitive disorder. It can affect memory, thinking, or~     concentration. It can cause mood changes. HAND may be caused by HIV hiding in the central~     nervous system then causing inflammation. Researchers want to see if a drug for inflammation~     (Anakinra) can help people with HAND.~      Objective:~      To see if a drug for inflammatory diseases is safe for people with HIV-associated~     neurocognitive disorder (HAND).~      Eligibility:~      Adults 18-61 years old with HIV who are enrolled in another study.~      Design:~      Participants will be screened with medical history, physical exam, and blood and urine~     tests.~      Participants will have up to 15 study visits over 16 weeks.~      At study visit 1, participants will have:~      Screening tests repeated.~      Brain magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a~     metal cylinder in a strong magnetic field. They will get a dye inserted by a thin plastic~     tube in a vein.~      Lumbar puncture. The lower back will be numbed. A needle will collect fluid from between~     bones in the back.~      Tests of memory, thinking, and attention. Participants may also fill out forms and do tasks.~      Participants will learn how to inject the study drug. Over 8 weeks, they will give~     themselves the study drug at home every day. They will do up to 3 injections at once. They~     will write down their injections and any side effects.~      Participants will have 5 weekly visits while taking the study drug. They will answer~     questions and have blood drawn.~      At weeks 8 and 16, they will have a visit that repeats visit 1.~   "
40456|NCT02527447|"~     Background:~      -Acute myeloid leukemia (AML) is a cancer of the white blood cells. It can be fatal.~     Standard treatment involves intensive chemotherapy. Not all treatment works. AML that has~     not responded to treatment (refractory) or that has returned after treatment (relapsed) is~     high-risk even with treatment. Success of therapy is normally determined after 28 to 56~     days. This study will see if a blood test on day 4 of therapy can help identify earlier~     those who will not respond.~      Objectives:~      -To see if a blood test on day 4 of therapy can help identify those who will not respond to~     treatment for AML.~      Eligibility:~      -People ages 18-70 who have refractory or relapsed AML and have had at least one previous~     therapy for it.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have:~        -  Several blood tests.~        -  Bone marrow exams: a needle is inserted into the hip to take cells from the bone~          marrow.~        -  Echocardiogram: a small probe is held to the chest to take pictures of the heart.~        -  ECG: soft electrodes are stuck to the skin. A machine records the heart s signals.~        -  CT scans: they will lie in a machine that takes pictures of the body.~        -  Standard chemotherapy.~        -  Possible transfusions of blood products such as red blood cells or platelets.~        -  Participants will be expected to stay in the study typically for 2 3 months. This will~          include inpatient treatment. Inpatient stay normally will be 1 or 2 months.~   "
40457|NCT02527434|"~     A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with~     Advanced Solid Tumors~   "
40458|NCT02527421|"~     This study evaluates the potential of HPA suppression in adolescent patients with moderate~     to severe plaque psoriasis when using DFD01 Spray (twice daily for either 15 or 29 days) vs.~     Comp01 Lotion (twice daily for 15 days).~   "
40459|NCT02527408|"~     This study will address the feasibility of using wrist-worn fitness trackers to monitor~     hospital inpatients. The study is being conducted in the Intensive Care Unit where patients~     are closely monitored, in order to provide gold standard measurements of heart rate, and~     accurate estimates of sleep quality.~   "
40460|NCT02527395|"~     The purpose of this prospective study is to investigate how close Heat Pain Detection~     Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical~     pain model Brief Thermal Sensitization.~      Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min.~     heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing~     Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary~     hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.~   "
40461|NCT02527382|"~     The purpose of this study is to check if there is a difference in peritoneal contamination~     in patients undergoing rectal resection with closed and open rectal stump prior to~     anastomosing.~   "
40462|NCT02527369|"~     This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive~     temporary reduction of thighs circumference by disruption of adipocyte cells.~   "
40463|NCT02527356|"~     The three purposes of this study are: 1) to examine the feasibility and effects of ride-on~     car training with two different postures on mobility and socialization in toddlers with~     disabilities; 2) to quantify whether toddlers with disabilities are able to have more~     exploratory behaviors and social interactions with ride-on car training through observation~     and wrist-worn accelerators; 3) to determine the critical factors of using the different~     modes of modified ride-on toy car on family perceptions and participation. Independent~     mobility is believed to be essential for perceptual-motor, cognition, language and social~     skill development. It is important to increase independent mobility in toddlers with~     disabilities and further enhance their development, especially socialization. Assertive and~     power mobility devices allow toddlers with disabilities to move independently within their~     environment and may increase the opportunities to explore environment and interact with~     people. However, issues to consider before prescribing an assertive device include factors~     such as age, accessibly to community environments, cost, and social acceptance of the device~     and the adaptability of the device to growth. To address these limitations and meet~     toddlers' needs, the concept of using modified ride-on toy cars (ROC) in therapy becomes a~     novel application. Studies have demonstrated the use of toy cars enhanced a child's~     motivation, socialization and family participation. Investigator preliminary results of the~     group study showed significantly increased mobility, socialization and decreased parenting~     stress level after the toy car training in toddlers with disabilities.~      More percentages of participants in the treatment group had clinical meaningful improvements~     on mobility and social function than the control group. Evidence supported that specificity~     of psychological changes associated with different modes of locomotion, particularly the~     loco motor experience involving motor activity, e.g., postural control; the perceptual~     information (e.g., periphery optical flow) and action experience affect psychological~     development.~      Therefore, this study is further to examine the effects of ride-on toy car training with two~     different postures, i.e., sitting and standing , on independent mobility, exploration and~     socialization through low-cost, family-centered approach. It will also improve family's~     understanding of children's capabilities, which improves their development. Based on the~     power analysis from the preliminary results of investigator group study, investigators will~     recruit 60 children with disabilities who are between 1 to 3 years old and diagnosed as~     motor delay (>1.5 sd). They will be randomly assigned to one of the following three groups:~     ROC-Sit group, ROC-Stand group and regular therapy group. The whole study duration will be~     24 weeks, including 12-week intervention and 12-week follow-up; the total amount of~     treatment will be equal for three groups. Standardized assessments are provided for a total~     of three times during the study, including the time before and after the intervention and in~     the end of the follow-up phase. The ROC-Sit and ROC-Stand programs will be administered by~     the therapist and include 120 minutes/per session, 2 sessions/per week. The research team~     will visit the hospital once/per week to provide 60 minutes videotaping and let participants~     wear wrist-worn accelerators. The regular therapy group will continue their regular therapy~     without any additional car driving training. The research team will visit them once/per week~     for the assessments. The assessments include standardized measurements and behavioral coding~     from the videotapes and accelerators.~      The findings of this study will provide a novel therapeutic tool (i.e., combining the~     low-tech modified ride-on cars with different postures) on advancing children's mobility,~     socialization, family participation and development.~   "
40464|NCT02527343|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen~     (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy.~   "
40465|NCT02527330|"~     Heart failure from myocardial iron deposition is a severe complication for patients with~     hematological disorders who need repeated blood transfusions. Increased cardiac iron content~     impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis,~     and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited~     in the myocardium.~      Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate~     the amount of iron in the heart. Myocardial T2* value has been shown to correlate well with~     biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms~     (indicating elevated iron) were found to be associated with LV dysfunction and improve in~     concert with LV function during recovery. The majority of the recent studies about~     myocardial iron overload and the effect of iron chelation therapy were focused on patients~     with transfusion-dependent hematological disorder, especially beta-thalassemia major.~      The objective of this 3-year project is to evaluate myocardial iron deposition in patients~     with heart failure, induced by variable causes. With myocardial T2* imaging, the~     investigators will analyze the decreased signal intensity in the ventricular septum and~     quantitatively acquire the T2* value as marker for myocardial iron deposition. The first~     year is a cross-sectional study. The investigators aim to compare the severity of myocardial~     iron deposition of normal subjects and that of stable HF patients in recovery with normal or~     impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in~     each group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal~     study of 40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three~     time points, i.e., disease onset, 6 months and one year after treatment, and will be~     followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will~     be performed in the 2nd and 3rd years. The presence and severity of myocardial iron~     deposition will be correlated with the disease course, patient biochemistry data and~     clinical outcome.~   "
40466|NCT02527317|"~     This is a prospective, non-interventional, single arm study, which is examining doxorubicin~     and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast~     cancer.~   "
40566|NCT02526017|"~     This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and~     clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced~     cancers.~   "
45748|NCT02458196|"~     This is an open-label randomized controlled trial to compare the efficacy of Prednisone~     alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.~   "
40468|NCT02527291|"~     We hypothesized that the stress of cardiac surgery and cardiopulmonary bypass can cause~     reactivation of a latent CMV infection and that reactivation might be more prevalent in~     patients with complicated post-operative course. The study aims are:~        -  To study whether cardiac surgery is a trigger for latent CMV reactivation and to~          compare reactivation rate between sub groups of patient with complicated post-operative~          course and non complicated post operative course.~        -  To study the relationship between expression IL28 SNP rs12979860 and the risk of CMV~          replication in the non immunocompromised patient undergoing cardiac surgery.~   "
40469|NCT02527278|"~     The research questions are:~        1. What is the proportion of women undergoing hysterectomy after hysteroscopic~          sterilization or laparoscopic tubal ligation?~        2. What is the proportion of women undergoing salpingectomy, salpingostomy, or~          hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?~        3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic~          sterilization or laparoscopic tubal ligation?~   "
40470|NCT02527265|"~     Primary Objective:~      -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1~     diabetes mellitus (T1DM).~      Secondary Objectives:~        -  To assess the ability to titrate the prandial and supplemental doses of Afrezza at each~          meal.~        -  To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4~          to 17 years with T1DM.~   "
40471|NCT02527252|"~     The purpose of the current randomized clinical trial was to analyze the effectiveness of~     craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life,~     isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood~     pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals~     with chronic low back pain.~   "
40472|NCT02527239|"~     Pompe's disease is a very rare condition which causes weakness of the respiratory muscles~     and may therefore cause symptoms of breathlessness or even respiratory failure, requiring~     the use of a ventilator at night. Recently a treatment for this condition has become~     available as well as a simple diagnostic test. However, we believe it is possible that there~     are patients with this condition who are presently undiagnosed attending respiratory~     clinics.~      We would like to complete an observational study of patients with respiratory muscle~     weakness of an unknown cause, who are attending respiratory clinics at two London centres,~     to determine whether patients attending these services have undiagnosed Pompe's disease.~   "
40473|NCT02527226|"~     This is a protocol to govern the prospective trial of facial nerve monitoring in patients~     undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor~     provides useful information to operating surgeons and if the information provided by the~     facial nerve monitor can predict degrees of postoperative facial nerve paresis.~      Additionally, the study will determine if performing daily facial rehabilitation exercises~     provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.~   "
40474|NCT02527213|"~     To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing~     analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an~     initial 28-day treatment phase.~   "
40475|NCT02527200|"~     This trial is conducted globally. The aim of this trial is to investigate the effect of~     liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.~   "
40476|NCT02527187|"~     The main objective is to evaluate the concentration of allergen extract of Betula verrucosa~     that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride~     10 mg / ml in size.~   "
40477|NCT02527174|"~     This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the~     polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus~     cytarabine induction chemotherapy for previously untreated patients with acute myeloid~     leukemia. (AML).~   "
40478|NCT02527161|"~     This is a prospective, non-randomized, longitudinal study of the clinical outcomes of~     participants that receive the Stryker Triathlon® Total Knee System for Total Knee~     Arthroplasty implanted using ShapeMatch® Cutting Guides.~      Health status and functional outcome measures will be recorded to quantify functional status~     of subjects before surgery and at each follow-up interval. This sub-study involved the~     assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and~     post-operatively.An assessment of post-operative patient outcomes compared to pre-operative~     status was also analysed.~   "
40479|NCT02527148|"~     This is a prospective, randomized, longitudinal study of the clinical outcomes of~     osteoarthritis patients treated by two different alignment philosophies for total knee~     replacement. In this study ShapeMatch® cutting guides will be compared to the conventional~     approach.~   "
40480|NCT02527135|"~     The purpose of this study is to determine whether regularly scheduled HIV sensitization text~     messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.~   "
40481|NCT02527122|"~     The main objective is to assess the concentration of extract allergen of Dermatophagoides~     pteronyssinus and Dermatophagoides farinae causing a papula of a size equivalent to that~     produced by a solution of dihydrochloride of histamine to 10 mgml.~   "
40482|NCT02527109|"~     The objective of the study is to examine the effect of Nifedipine, applied intra-anally~     through our drug delivery device, on rectal pain severity in anal fissure patients that are~     being managed with conservative treatment.~   "
40483|NCT02527096|"~     The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the~     two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected~     patients virologically suppressed with triple HAART.~   "
40484|NCT02527083|"~     Research suggests that the type of anesthesia used for surgery may affect intraoperative~     stress hormone levels. There is also data to support that an increased level of stress~     hormones leads to increased pain after surgery. The primary aim of this study is to~     determine the effect of anesthesia type on long term pain after hernia surgery. In this~     study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group,~     either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled~     Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences~     in short and long-term pain after hernia repair depending on type of anesthesia received.~   "
40485|NCT02527070|"~     Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations~     in skin blood volume. The objective of the current study is to investigate a potential~     relationship between MRT (minimum rise time, in time units) a measure derived from PPG and~     the state of microvessels.~      This study includes a 1-2 hour single session per subject during which PPG and other~     microvascular and systemic variables will be monitored in response to non-invasive~     interventions that are known to elicit microvascular responses.~   "
40486|NCT02527057|"~     Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually~     worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25%~     patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%.~     Concurrent chemoradiation followed by surgery results in better survival than~     single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends~     concurrent chemoradiation as preoperative or definitive treatment for patients with stage II~     or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some~     subgroup of these patients, and its toxicity can increase perioperative mortality and delay~     or preclude surgery. The ability to distinguish tumors that will respond or not respond to~     such therapy remains an urgent priority. Diffusion-weighted magnetic resonance~     imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the~     apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion~     of water molecules within tissues, which is mainly influenced by cell organization, size,~     and density. Cell death leads to a loss of cell membrane integrity and density and leads to~     increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer~     therapy. However, no one has published findings regarding the potential correlation between~     changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential~     predictive value of DW-MRI for predicting response to such therapy is important for the~     delivery of appropriately tailored treatment.~      Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant~     chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high~     risk of treatment failure from such therapy. Investigators will test this hypothesis with~     two specific aims: (1) assess the ability of ADC to predict pathologic response to~     treatment; and (2) assess the ability of ADC to predict disease-free survival and overall~     survival.~   "
40487|NCT02527044|"~     Assessing coronary graft functionality 6 months after in patients with complete arterial~     coronary artery bypass grafting.~   "
40488|NCT02527031|"~     Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause~     of death in a young population. Management of CA is defined by international~     recommendations, detailed by learned societies in each country. It includes several links~     that are interconnected for its optimisation. Despite all these improvements, no progress,~     or little has been made in the survival of CA victims over the past few years in~     industrialised countries, and the survival rate in France is 3% to 5%.~      Refractory cardiac arrest is defined as failure, after 30 minutes of specialised~     resuscitation. It used to be the standard to admit that there was no hope of spontaneous~     cardiac activity and satisfactory neurological recovery after this period, except in cases~     of CA with neuroprotection (intoxication, hypothermia).~      External circulatory support such as extracorporeal membrane oxygenation (ECMO) makes it~     possible to replace the circulatory activity of the myocardium and the respiratory activity~     of the lungs.~      In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival~     rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility~     of neurological recovery independent of the recovery of spontaneous cardiac activity which~     can be differed.~      These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac~     arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where~     the CA occurs. They are then transferred to a specialised centre. The significant~     improvement in survival noted in in-hospital CAs was not observed in the French series of~     studies concerning out-of-hospital CAs. This survival is currently estimated at 4%. This~     difference can be partly explained by the difference in time between the beginning of~     cardiac massage and the implementation of circulatory support by ECMO (low flow period).~     This time period is directly correlated to survival.~      To demonstrate the superiority of this strategy in terms of survival, investigators would~     like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO~     between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency~     physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with~     secondary transfer to the hospital for the implementation of support. The purpose is to~     increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests~     with a good neurological prognosis.~      Main objective:~      The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients,~     considering that the percentage of survival with in-hospital ECMO is less than 5%.~      Main judgement criterion:~      Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at~     6 months~      Secondary judgement criteria:~      Success rate of the implementation of ECMO ECMO implementation time Immediate complications:~     haemorrhage, infection Number of organ harvesting The quality of survivors' neurological~     status according to the CPC neurological classification at D 28, 2 months and 1 year~     Predictive indicators of the prognosis during cardiac arrest via cerebral and biological~     monitoring Methodology, type of study: This is a prospective randomised study of current~     care Sample size (SS, power, risk): A total number of 105 patients in each group will make~     it possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant~     difference in favour of early pre-hospital ECMO compared to the current practice with~     in-hospital ECMO.~   "
40489|NCT02527018|"~     Hypertensive disorders of pregnancy including preeclampsia are the leading cause of~     pregnancy related mortality in the United States. Timely and appropriate management of~     hypertensive disorders of pregnancy is critical to prevent complications such as kidney~     failure, HELLP syndrome, disseminated intravascular coagulation, placental abruption,~     intrauterine fetal demise, intracranial bleed, coma and death. (HELLP syndrome is a group of~     symptoms that occur inpregnant women who have: H -- hemolysis (the breakdown of red blood~     cells); EL -- elevated liver enzymes; LP -- low platelet count.) Hypertensive disorders of~     pregnancy include gestational hypertension (HTN), chronic HTN, preeclampsia and preexisting~     HTN with superimposed preeclampsia.~      Hypertensive disorders may also lead to significant maternal and/or fetal morbidity. Based~     on the severity of the disease process and gestational age of the fetus, decision needs to~     be made whether to proceed with immediate delivery or continue expectant management.~     Meanwhile, maintenance of optimal blood pressure, blood volume, and cardiac output are~     recommended to preserve placental perfusion and to prevent unfavorable maternal and/or fetal~     outcomes.~      Previous studies have demonstrated blood flow differences in pregnancies complicated by~     preeclampsia vs. healthy pregnant women evidenced by decreased arterial compliance,~     increased systemic vascular resistance and after load, and changes in blood volume and~     cardiac output. Additionally, various serum markers have been tried to identify women with~     preeclampsia. B-Type natriuretic peptide (BNP) has been consistently shown to be elevated in~     preeclampsia, and serves as a marker of heart function and intra vascular volume status.~      Continuous hemodynamic monitoring may play a crucial role in timely management of these~     patients with severe disease due to the dynamic nature of the disease process. Existing~     methods are not preferred in pregnancy due to their invasive nature, and there is lack of~     validated non-invasive means to provide real time information on various hemodynamic~     parameters including cardiac output in these critically ill pregnant women.~      Among new cardiac monitoring devices, the Nexfin device (BMEYE, Amsterdam, Netherlands) has~     recently been introduced. Nexfin device is a device approved by the Food and Drug~     Administration (FDA) as a non-invasive reliable method of continuous measuring arterial~     blood pressure in pregnant women. However there are no preliminary data on preeclamptic~     patients using this device. The standard of care is to use a sphygmomanometer for blood~     pressure monitoring. Additionally there are no studies comparing the hemodynamics of healthy~     and preeclamptic women using Nexfin device. Nexfin is thought to be superior over other~     available non-invasive methods as it is a safe and a considerably accurate method. Nexfin~     provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic~     vascular resistance and left ventricular contractility indices.~      The study aims to determine if the non-invasive Nexfin device can be used to reliably~     distinguish hemodynamics in preeclamptic vs. healthy pregnant women with singleton~     pregnancies along with use of BNP levels. Investigators aim to recruit 33 healthy controls~     and 33 subjects diagnosed with preeclampsia (mild and severe). Subject's systolic and~     diastolic blood pressures will be measured using both the Nexfin device and a standard~     sphygmomanometer (blood pressure meter). Additionally hemodynamic measure such as: heart~     rate, cardiac output, stroke volume, systemic vascular resistance, and left ventricular~     contractility will be recorded using the Nexfin device. Investigators will perform a blood~     draw to measure BNP levels as an additional assessment of the hemodynamic changes in the two~     groups.~   "
40490|NCT02527005|"~     Randomized controlled single blind prospective comparative study~   "
40491|NCT02526992|"~     Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults~     and is characterized by chronic inflammation of the joints leading to their destruction,~     resulting in a major loss of function.~      The investigators propose a pilot study for studying changes in bone microarchitecture with~     High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA~     treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural~     parameters in subchondral area near an inflammatory joint during the first 12 months of~     initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).~   "
40492|NCT02526979|"~     The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral~     suspension after single dose administration in children with neurogenic detrusor~     overactivity (NDO) or overactive bladder (OAB).~      This study will also evaluate the safety and tolerability as well as the acceptability and~     palatability of mirabegron oral suspension after single dose administration in children with~     NDO or OAB.~   "
40493|NCT02526966|"~     The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a~     prognostic value (which could increase the risk of Renal Absolute), the longitudinal~     monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in~     place including a possible repetition renal biopsy); (2) to guide treatment decisions and~     (3) in clinical research, as an outcome (in substitution for the occurrence of kidney~     failure) in therapeutic trials IgA nephropathy.~      This research project constitutes the first step in validating these antibodies biomarker of~     IgA nephropathy and its main objective is to study the performance of the blood levels of~     anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA~     nephropathy as defined by the Renal Risk Absolute.~      The secondary objectives of this project are to establish a bio-collection that will allow~     us to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy~     and to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new~     international histological classification.~   "
40494|NCT02526953|"~     The purpose of this study is to determine whether the combination of paclitaxel,~     capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the~     standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT)~     in patients with squamous-cell anal cancer.~   "
40495|NCT02526940|"~     Although combined antiretroviral therapy (cART) has dramatically improved quality of life~     and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The~     Gut Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most~     of HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells.~     Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to~     gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early~     establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an~     early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could~     be also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17~     secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion~     could be associated with HIV progression since these cells play a crucial role in the~     maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of~     the intestinal epithelial barrier integrity. These damages are responsible for an increase~     in microbial translocation, which is associated with immune activation and progression to~     AIDS. Several recent studies have shown that cART initiation during acute or early HIV-1~     infection reduces HIV DNA reservoir size and improves immune reconstitution in blood.~     Post-treatment controllers, who started long-term cART early after HIV infection, have very~     low levels of HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers.~     Unlike most HIV-infected individuals, they maintain an undetectable plasmatic viral load~     after several years of cART interruption, suggesting that a weak reservoir is a prerequisite~     to achieve a functional cure. By extrapolation, it could be hypothesized that the gut viral~     reservoir is also decreased and that mucosal immunity is restored when cART is initiated~     during primary phase of infection. The gut viral reservoir begins to form within the first~     days after HIV exposure, and grows during acute HIV infection. Similarly, intestinal T cells~     are depleted very early after infection, due to high viral replication, host immune response~     and bystander effects. Most studies also concluded that long-term and optimal treatment~     can't fully restore mucosal immunity. These observations led us to study the impact of time~     of cART start on the size of viral reservoir and on immune reconstitution in the gut. For~     this, we analyzed the virological and immunological characteristics of the rectal HIV~     reservoir of long-term treated patients regarding their blood CD4+ T cells count at the time~     of cART initiation.~   "
40524|NCT02526563|"~     The primary investigators in this study plan to investigate serum concentrations of~     ropivacaine in pediatric patients who already receive as standard of care a continuous wound~     catheter after an iliac crest alveolar bone graft harvest for completion of a previous cleft~     palate repair.~      The goals of this study are 1) to determine serum concentrations (free, unbound) of~     ropivacaine 2) To evaluate pain scores during the perioperative period to determine efficacy~     of wound catheters for postoperative analgesia for iliac crest bone graft harvest.~   "
40496|NCT02526927|"~     The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces~     starvation, stop of growth and impaired mineralization of bone tissue together with an~     interruption of pubertal development. These consequences are initially reversible following~     food intake return but can lead to a more irreversible status with low height, osteoporosis~     and high fracture risk. The onset of the disease more and more early in life, with the first~     stages of puberty suggest that these consequences will be even more severe as bone~     resistance will be damaged by more profound effects on bone growth as well. It is therefore~     critical to evaluate these bone metabolism alterations in order to better manage these~     patients.~      At every age and in every clinical circumstance either physiologic or pathologic, high~     resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation~     of bone microarchitecture that is more informative than the global quantitative assessment~     given by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of~     clinical fracture risk.~      Here, we propose to measure cortical parameters, such as cortical thickness which plays a~     key role in bone biomechanical strength in young adults aged between 20 and 30 years-old,~     who had developed AN as early as the during the first stages of puberty but no longer~     present, compared to age-and sex-matched healthy volunteers. Other micro-architectural~     parameters will also be studied. In an exploratory phase, we will evaluate these bone~     microarchitectural parameters together with bone biological turnover markers and markers of~     sexual maturation in adolescents or young adults 20 years-old or less, undernourished and~     currently managed for AN.~   "
40497|NCT02526914|"~     The purpose of this study is to investigate the role of a one-time intranasal administration~     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation~     and competition in a healthy population of student controls.~   "
40498|NCT02526901|"~     The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and~     long-term effects of exposure in early life on health consequences in Guangzhou, China. Data~     are collected regarding environmental, occupational and lifestyle exposures as well as~     health outcomes in later life. Biological samples including blood and tissue samples are~     also collected from the participants.~   "
40499|NCT02526888|"~     The main objective of this study is to investigate whether repeated administration of a~     cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of~     presence in the blood) of ACT-541468~   "
40500|NCT02526875|"~     To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine~     (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately~     Controlled by Telmisartan Monotherapy~   "
40501|NCT02526862|"~     This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM-~     mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU),~     compared with other three usual preventive measures which consist in the use of three~     different medical devices.~   "
40502|NCT02526849|"~     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in~     adults with slow transit constipation.~   "
40503|NCT02526836|"~     The aim of this study is to compare between complete mesocolic excision with central~     vascular ligation and conventional surgery of colon cancer regarding number of harvested~     lymph nodes, surgical outcome and complications.~   "
40504|NCT02526823|"~     Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation~     related cardiac toxicity limits their clinical application, especially adriamycin.~     Adriamycin has been gradually replaced by epirubicin. Polyethylene glycol liposome~     doxorubicin (PLD) can go into tumor tissues through tumor angiogenesis and produces targeted~     killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant~     tumors,including lymphoma.~   "
40505|NCT02526810|"~     The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and~     oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with~     oral drugs and the other is continuous subcutaneous insulin injection.~   "
40506|NCT02526797|"~     To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate~     cancer can improve the selection of patients suitable for Active Surveillance and have a~     relevance in the ongoing monitoring.~   "
40507|NCT02526784|"~     The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions)~     following degarelix subcutaneous (s.c.) administrations with two different injection~     techniques and intramuscular (i.m.) administration in patients with hormone dependent~     prostate cancer.~   "
40508|NCT02526771|"~     The aim of this study is to compare the surgical outcomes of conventional lymph node~     dissection with unconventional lymph node dissection during resection of Intrahepatic~     cholangiocarcinoma.~   "
40509|NCT02526758|"~     Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by~     progressive development of airflow limitation. Small airway disease (obstructive bronchitis)~     and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow~     limitation. Research shows that small airway resistance increased by 4-40 times in COPD~     patients, and become the main part of the airflow obstruction. Impulse oscillation system~     (IOS) is able to measure the total airway resistance, the central airway resistance and the~     peripheral airway resistance, which is now widely used to assess small airway function in~     COPD patients. While High resolution CT (HRCT) is easy to operate and its images are~     intuitive. Meanwhile it can measure the proportion of emphysema, the airway diameter and the~     thickness of airway wall. Both of these two tests have great significance in small airway~     evaluation. Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) is an~     acute onset process, which is characterized by the aggravation of respiratory symptoms and~     deterioration of pulmonary function. However, the structural and functional changes of small~     airway in AECOPD are not clear. Inhalation drugs are the main treatment for stable COPD ,~     and inhaled corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients~     with severe and severe airflow limitation. The particles in traditional inhalation drugs are~     larger and mainly deposited in large airways, and their effects on small airway function are~     relatively small.~      The objectives of the investigators study are COPD patients. The study is divided into two~     parts, that is the part of AECOPD patients and the part of stable patients . Patients with~     AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients~     with stable COPD are randomized to take either beclomethasone / formoterol (particle~     diameter for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure~     and function changes of small airway in different stage will be evaluated and the efficacy~     of these two drugs is to be compared. This study is expected to highlight the investigators~     understanding on the role of small airways in COPD, and provide a guideline to clinical~     standardized treatment as well as evaluation of patients' conditions.~   "
40510|NCT02526745|"~     This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged~     50 years and older. Half of participants will receive high doses of the vaccine,while the~     other half will receive low doses of the vaccine in phase I clinical trial. At the phase II~     clinical trial, participants will be distributed equally to four groups(low、middle, high~     doses of the vaccine and placebo).~   "
40511|NCT02526732|"~     The aim of the study is to examine the influence of hepatic inflammation or damage on~     physical performance (maximal oxygen uptake, VO2max) depending on the histologic state of~     the liver. The study population are patients with fatty liver disease and non-alcoholic~     steatohepatitis (NASH). All study participants obtain an individual training plan with~     individual and group training sessions for a period of 8 weeks. At the beginning and end of~     the training phase a sport physiological examination is carried out. In the study group the~     effect of regular examinations is surveyed by surrogate parameters of liver inflammation.~   "
40512|NCT02526719|"~     The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to~     reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation~     of the nipple and areola complex during mastectomy and breast reconstruction is associated~     with improved quality of life and a better cosmetic result. However, this surgical technique~     relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain~     proportion of women will actually lose their preserved nipple-areolar complex due to~     vascular insufficiency. Furthermore, some women may find out after a nipple-sparing~     mastectomy that cancer had invaded the nipple-areolar complex, and would require another~     operation to completely remove the cancer. Despite these devastating complications, there~     have been no controlled studies to investigate mechanisms to reduce the chance of their~     occurrence.~      Our research study will use a pre-operative minor procedure to enhance blood flow to the~     nipple-areola complex prior to standard nipple sparing mastectomy among eligible women~     undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test~     how many women actually have active cancer in their nipple at the time of this minor~     surgical procedure, prior to standard NSM. The investigators hypothesize that our innovative~     and novel nipple-delay procedure will reduce the risk of loss of the nipple due to vascular~     insufficiency and may be of benefit to identify the small proportion of women with~     nipple-areola complex involvement, in order to optimize the ultimate cancer ablation.~      For this study the investigators propose to undertake a Pilot RCT as the first step in the~     evaluation of a delay procedure prior to NSM, and the results will be used to determine the~     feasibility and inform the optimal design for a definitive RCT. This study question has the~     potential to set a new standard of care in the management of women seeking NSM for the~     management of their breast cancer.~   "
40513|NCT02526706|"~     The investigators aim to conduct a prospective clinical pilot study to investigate the use~     of VisionBlue staining administered during cataract surgery to 20 patients with history of~     trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb.~     The investigators also aim to develop a standard classification system for assessing~     filtering bleb function during cataract surgery.~   "
40514|NCT02526693|"~     The Konan RAPDx (Konan Medical USA, Irvine, CA) is a newly patented pupillography device.The~     aims of this study are to assess the ability of the RAPDx to distinguish between healthy~     subjects and patients with confirmed glaucoma using standard testing sequences, assess the~     ability of the RAPDx to distinguish between healthy subjects and patients with confirmed~     glaucoma using a customized testing sequence developed for use at the Wills Eye Hospital~     Glaucoma Research Center and to determine the combination of demographic, clinical, and~     RAPDx testing parameters which allow for maximum sensitivity and specificity in~     discriminating healthy subjects from those with glaucoma.~   "
40515|NCT02526680|"~     To determine the impact of OrCam on health-related quality of life (HRQoL) in subjects with~     advanced glaucoma over 1 month and to assess health-related quality of life using the~     National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25).~      To determine the tasks for which the subjects are using the OrCam device and patient~     satisfaction and to analyze qualitative data from weekly patient logs, in order to determine~     efficacy of OrCam.~   "
40516|NCT02526667|"~     Demonstrate the reduction of bacteria on the skin.~   "
40517|NCT02526654|"~     The main purpose of this study is to compare standard automated perimetry (SAP) using the~     Heidelberg Edge Perimeter (HEP) with the Octopus Visual Field (OVF) analyzer and determine~     test-retest reliability of both parameters in detecting glaucomatous visual field losses. A~     secondary outcome measure is investigation of novel imaging parameters of the optic nerve~     head and a new automated structure-function report.~   "
40518|NCT02526641|"~     Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of~     chronic viral hepatitis C infection on the macrophage specific activation marker soluble~     CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and~     metabolic liver function determined by the galactose elimination capacity (GEC) test and the~     functional hepatic nitrogen clearance (FHNC).~   "
40519|NCT02526628|"~     The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is~     compared to healthy controls by using specific biochemical assays for coagulation and~     fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the~     effect of gonadal status and any effects of long- or short-term testosterone treatment on~     the above mentioned parameters are investigated.~   "
40520|NCT02526615|"~     The objectives of this study are to compare the effects of rosiglitazone and metformin on~     insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal~     muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during~     euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26~     weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be~     randomized to receive either rosiglitazone or metformin or placebo, according to a simple~     randomization procedure with double blinding.~   "
40521|NCT02526602|"~     Urinary incontinence and impotence are typical disturbances after radical prostatectomy.~     Although, several surgical methods are developed to decrease these disturbances, 8% and 50%~     of the patients suffer from permanent urinary incontinence and impotence, respectively.~      Previously two studies have shown that endopelvic fascia preservation may decrease~     postoperative incontinence and impotence rates. Unfortunately these studies are~     retrospective decreasing their reliability.~      The present study is prospective and randomized clinical trial. The investigators are going~     to randomize 180 patient to preservation and opening the endopelvic fascia groups.~     Functional and oncological results are followed up to 1 year after surgery.~   "
40522|NCT02526589|"~     Traditionally the watertightness of urethrovesical anastomosis after robotic radical~     prostatectomy is controlled by cystogram. However, clinical observations and one previous~     study showed that patients with anastomotic leakage have red coloured urine. If the~     investigators can verify this finding, the most of the cystograms can be avoided. In this~     study the investigators estimate urine colour after cystogram and take a picture from urine~     collecting pag. Later on the pictures are digitally analyzed and compared to cystogram~     finding.~   "
40523|NCT02526576|"~     This phase two, randomized, double-blind study is designed to demonstrate the enhanced~     efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF~     enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted~     region over the course of one year.~   "
40526|NCT02526537|"~     Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer~     (NSCLC) patients who received radical resection remains controversial. There is still no~     clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve~     the survival rate for patients with stage Ib NSCLC. Tyrosine Kinase Inhibitors (TKIs) such~     as Gefitinib and Erlotinib are widely accepted as the first-line therapy for Epidermal~     growth factor receptor (EGFR) gene mutation late stage NSCLC patients. However the effect is~     largely uncertain for early stage patients who received surgery. The investigators aim to~     evaluate the effect of postoperative adjuvant use of Gefitinib for high risk stage Ib EGFR~     sensitive mutation NSCLC patients.~   "
40527|NCT02526524|"~     The purpose of the study is to compare the glycemic effects of delayed-release metformin~     (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The~     study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the~     morning [qAM]) compared to placebo. A single-blind reference treatment of 2000 mg metformin~     immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID)~     will also be included.~   "
40528|NCT02526511|"~     This pilot clinical trial studies perfusion magnetic resonance imaging in diagnosing~     patients with kidney tumors. Diagnostic procedures, such as perfusion magnetic resonance~     imaging, may help find and diagnose kidney tumors and predict and monitor a patient's~     response to treatment.~   "
40529|NCT02526498|"~     This phase II trial studies how well accelerated partial breast irradiation (APBI) using~     high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has~     not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery.~     Radiation therapy uses a type of energy to kill cancer cells and shrink tumors.~     Brachytherapy is a type of internal radiation therapy that provides radiation inside the~     breast to any remaining tumor cells next to the space where the tumor was removed, and is~     given over a shorter amount of time than standard radiation therapy. Giving accelerated~     partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the~     overall time that radiation is delivered to the tumor cells.~   "
40530|NCT02526485|"~     The purpose of this research is to identify genomic markers that can predict heparin-induced~     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly~     used to prevent blood clots and the investigators may be able to identify genomic markers~     which can be used to prevent heparin use in people who will get HIT.~   "
40531|NCT02526472|"~     One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos,~     randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on~     day 2-3 of culture was performed using a soft catheter either under trans-abdominal US~     guidance (UGET group) or after measurement of uterine cavity by transvaginal US and~     calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy~     rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort~     during ET procedure.~   "
40532|NCT02526459|"~     The study design is a prospective, single institution, randomized control trial in which the~     introduction of a birth plan is the intervention and a comparison of the rate of Caesarean~     sections between participants in the control group (no birth plan) and the experimental~     group (birth plan) is the primary outcome.~   "
40533|NCT02526446|"~     This proposed study is to evaluate the effectiveness of a self-administered acupressure~     intervention on caregiver stress and associated distress symptoms of fatigue, insomnia and~     depression in Chinese family caregivers of an elderly family member.~   "
40534|NCT02526433|"~     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least~     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying~     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the~     UK do not have a strategy for treating PND, and flaws in the current pharmacological and~     psychological treatment models. Consequently, research into promising psychosocial~     interventions such as music is critical to developing new paradigms for treating PND.~      Singing away the Blues is an ambitious programme of research that investigates links between~     the mental health of women in the later stages of pregnancy and first 9 months post birth~     and their use of psychosocial interventions including music.~   "
40535|NCT02526420|"~     A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for~     five months in adults with GHD.~   "
40536|NCT02526407|"~     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least~     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying~     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the~     UK do not have a strategy for treating postnatal depression, and flaws in the current~     pharmacological and psychological treatment models. Consequently, research into promising~     psychosocial interventions such as music is critical to developing new paradigms for~     treating postnatal depression.~      Singing away the Blues is an ambitious programme of research that investigates the effects~     of music on postnatal depression through two phases: a questionnaire study and an~     intervention study. This record is for the intervention study. The questionnaire study has a~     separate record. We are accepting host hospital sites for both.~   "
40537|NCT02526394|"~     The trial includes groups receiving various combinations of meningitis C and pertussis~     containing vaccines, to be administered concomitantly in adolescents due their school~     leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of~     age). Immunogenicity and reactogenicity will be assessed.~   "
40538|NCT02526381|"~     Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin~     Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be~     launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood~     coagulation function evaluation of the relationship between disease and biochemical basis,~     detect plasma metabonomics and the gene expression profile chip, with phlegm - lipid~     metabolic disorder, stasis - microcirculation disorder, alternating knot - inflammation~     mediated and other system related to the biological basis. With Danlou Tablet for~     treatment, the investigators can observe result/effect index of turbid phlegm and blood~     stasis syndrome. Through comprehensive comparison of multi-level, multi-targets and~     multi-date biological index to discuss its sickness-syndrome-prescription corresponding~     relation and its biological basis.~   "
40540|NCT02526355|"~     The prevalence rate of postnatal depression in Pakistani women and its effect on the growth~     and development of young children and child mortality is very high.~      The main objective of this study is to increase access to evidence based psychological~     interventions for mothers who have children of age 0 to 12 months, consistent with her~     values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled~     trail. Depressed mothers will be randomized either to intervention arm or control arm.~     Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).~   "
40541|NCT02526342|"~     Aim of the study is to prove the utility and safety of the negative pressure wound therapy~     (NPWT) in the postoperative management of free flaps.~      The quantitative assessment of the entirety of clinical main relevant parameters like edema~     formation, microcirculation, macrocirculation and wound healing should create a better and~     comprehensive understanding of the NPWT effects in this field.~   "
40542|NCT02526329|"~     This phase I trial studies the side effects and best dose of donor regulatory T cells in~     treating patients with graft-versus-host disease affecting the liver or gastrointestinal~     organs (visceral) within 100 days (acute) after undergoing a stem cell transplant.~     Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant~     attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a~     type of immune cell that may be able to reduce the attack of the donor's immune cells on the~     patient's normal cells and help treat graft-vs-host disease.~   "
40543|NCT02526316|"~     The study will include 10 patients with HPV-associated ano-genital cancer (cervical, vulvar,~     vaginal, penile, anal) or HPV-associated head and neck cancer, who are planned to receive a~     cisplatin-based chemotherapy (alternatively a carboplatin-based chemotherapy may be selected~     by investigators choice). Patients will receive P16_37-63 peptide (100 µg) combined with~     Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest~     period (1 cycle). The vaccination is to be started one week before the initiation or~     continuation of the cisplatin-based chemotherapy. Concurrent radiation is allowed and should~     be documented. The vaccination schedule will be repeated up to a total of 3 cycles (= 6~     months) or until progression or intolerable toxicity. If chemotherapy is withheld (e.g. for~     toxicity), vaccination treatment can be continued.~   "
40544|NCT02526303|"~     The purpose of this study is to determine the safety and efficacy of anticoagulation in the~     treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.~   "
40545|NCT02526290|"~     In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal~     Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be~     evaluated.~   "
40546|NCT02526277|"~     The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy~     may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the~     MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS.~     Participants will be randomly assigned to one of four treatment groups;~        1. MMF07 Foot Massager device~        2. Heat therapy~        3. Heat therapy and the MMF07 Foot Massage device~        4. Neither heat nor MMF07 Foot Massager device (no treatment group)~   "
40547|NCT02526264|"~     Patients with colorectal cancer prior to stoma surgery are randomized to different~     preoperative education programs: (a) specific preoperative education, (b) standard~     preoperative education. Outcome measures are quality of life, period of hospitalization and~     complication rates.~   "
40548|NCT02526251|"~     The purpose of this cohort study is to map, during one year in an e-health setting, patients~     having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to~     dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires~     (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how~     dysbiosis defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in~     disease activity and FC under different treatments scenarios. Is a certain DI or specific~     bacteria probes related to increase or reduced relapse rate. Moreover change in above~     mentioned parameters/indices will also be correlated to QoL and a fatigue score.~   "
40549|NCT02526238|"~     This is a double blinded, randomized control trial with a pretest-posttest control and~     interventional group design. The assessor is blinded to all assessments and evaluations. All~     patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened~     initially by a series of screening test. Suitable patients are assigned randomly to two~     groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation~     (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and~     placebo stimulation.~   "
40550|NCT02526225|"~     The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone~     meglumine injection tn the treatment of acute ischemic stroke~   "
40551|NCT02526212|"~     The primary goal of this research is to improve the effectiveness of buprenorphine~     maintenance treatment (BMT) within primary care.~      Investigators propose that providing BMT as part of a group medical visit (instead of an~     individual visit) will improve treatment outcomes for patients with persistent opioid abuse,~     because members become accountable to the group, are exposed to beneficial habits of others~     (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly~     with medical management~   "
40552|NCT02526199|"~     To extend the duration of peripheral nerve blockade after major foot and ankle surgery the~     investigators randomize the postoperative treatment with either perineurial sciatic nerve~     blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.~   "
40553|NCT02526186|"~     We will conduct a randomized controlled trial to determine whether the addition of~     battlefield auricular acupuncture to standard of care is effective for control of postpartum~     pain for mothers in the immediate post-partum period. Post-partum patients (DoD~     beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a~     childbirth in a hospital setting will be offered the opportunity to participate in the study~     through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal~     delivery or 24 hours post caesarean section subjects will be given treatment according to~     their randomization group. Subjects will be assessed on pain control, overall satisfaction~     with pain management, and the amount of pharmacological pain medications used. Safety of~     measures will also be assessed to include infection rates, syncope, vertigo, and~     hypotension.~   "
40555|NCT02526160|"~     UX023-CL303 is a phase 3 multicenter, randomized, double-blind, placebo-controlled study to~     evaluate the efficacy and safety of KRN23 in adult subjects with XLH. Approximately 120~     subjects with a diagnosis of XLH supported by clinical and biochemical features consistent~     with XLH and/or a confirmed PHEX mutation (self or family member consistent with X-linked~     inheritance) and with bone or joint pain at baseline will be enrolled. Subjects not~     receiving supplementation therapy with oral phosphate and active vitamin D metabolites or~     those willing to discontinue supplementation therapy are eligible.~   "
40556|NCT02526147|"~     This evaluation is part of a five country project to evaluate the benefits and costs of the~     use of two alternatives to food transfers: vouchers and cash (hereafter referred to as~     alternative modalities). The project will generate information on how outcomes such as~     household food expenditure and dietary diversity, relevant to both beneficiaries and WFP,~     change following the introduction of these alternative modalities; how benefits and costs of~     these are, relative to food transfers, distributed across and within households; and what~     are the critical operational issues that need to be addressed for these alternatives to be~     successfully implemented. More specifically, the project will answer seven questions:~        1. Do households benefit from receipt of the alternative modalities?~        2. Are these benefits greater, or less, when transfers are made using alternative~          modalities compared to food transfers. How does this vary across outcomes (such as~          nutrition, livelihoods, gender dynamics and intra-household resource allocation) that~          are of especial interest to WFP?~        3. How does the distribution of benefits differ across households when transfers are made~          using alternative modalities compared to food transfers?~        4. How does the distribution of benefits differ within households when transfers are made~          using alternative modalities compared to food transfers? Do certain household members~          (women, young children) benefit more from one type of modality? How do these modalities~          affect decision-making processes within the household?~        5. Why are these differences observed? How do the reasons for these differences affect the~          study's ability to generalize from these evaluations?~        6. Does the delivery of alternative modalities cost less than food transfers? What~          accounts for these cost differences? Are some costs (such as transport) really lower or~          are they transferred to beneficiaries? Within the household, who bears these additional~          costs?~        7. What is the benefit: cost ratios associated with these different modalities from the~          perspective of WFP? Is there a conflict between the modality preferred by WFP and the~          modality preferred by beneficiaries?~      These objectives will be accomplished through household survey data collection among a panel~     of households before and after transfer of alternative modalities. In addition, select~     countries will involve the collection of anthropometric, biomarker and cognitive testing.~   "
40557|NCT02526134|"~     The purpose of this study is to estimate the rate of patients in whom a significant change~     in the area to be irradiated will be observed between the assessment before and after laying~     the evaluation of Trustees.~   "
40558|NCT02526121|"~     The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on~     blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload,~     compared with a dietary intervention alone.~      All subjects in this study will follow dietary and lifestyle counseling in a period of 3~     months.~      A randomized group will receive phlebotomies every 3 weeks in this period.~   "
40559|NCT02526108|"~     The purpose of this study is to assess the energy expenditure and intensity of a High~     Intensity Functional Training (HIFT) session in overweight and obese adult men and women.~   "
40560|NCT02526095|"~     This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor~     after surgery.~   "
40561|NCT02526082|"~     The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started~     in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention~     trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up~     through national registers since the 1980, and since 2000 with regular questionnaire~     surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random~     subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.~   "
40562|NCT02526069|"~     Study Objectives:~      This study aims to assess the feasibility and acceptability of an application utilising~     Acceptance and Commitment Therapy in young people with type 1 diabetes.~      Primary Research Questions:~      Is an ACT based application feasible and acceptable to young people with type 1 diabetes.~      Study Design:~      Patients will use the app for four weeks and then be invited to attend an interview~     discussing the acceptability, usability and feasibility of the app. Clinician's will also be~     invited to take part in a workshop where they interact with the app and provide feedback.~      Consent for will be obtained through the app. Additional consent for the recording of~     interviews will be obtained in paper format and stored in a secure locked cabinet at~     Edinburgh University.~      Quantitative data will also be collected on well-being, psychological flexibility, and data~     usage.~      Data Collection~      Qualitative feedback:~      Interviews will be recorded and transcribed using unique identifiers.~      Outcome measures and data usage patterns:~      Data will be collected on a password protected database which can only be obtained via a~     password protected and encrypted server from University of Edinburgh.~      Data Analysis:~      Phase 1:~      Framework analysis and interpretive phenomenological analysis will be utilised to create~     themes from the qualitative feedback.~   "
40563|NCT02526056|"~     This study is a usability design with qualitative and quantitative aspects. In one part,~     with patients, physical strain and designs facets will be investigated and in another part~     with physiotherapists, the therapeutic relevance and design features will be explored.~      For this reasons 13-15 elderly people have to play an exergame, during their game playing~     process, different measurements will be done. Additional 13-15 physiotherapists will also~     playing the exergame, they will be asked about their opinions about the game.~   "
40564|NCT02526043|"~     The purpose of the study is to observe the curative effect and safety of laparoscopic versus~     open liver resection for hepatocellular carcinoma.~   "
40565|NCT02526030|"~     The selection of antipsychotic in early stages of the illness is mainly determined by its~     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug~     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a~     homogeneous group and clinical effects and profile of side effects differ between SGAs.~     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of~     increasing research interest, although comparisons between the different SGAs are scarce. In~     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to~     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less~     evident seems to be the notion that some of the SGAs might be more effective (in terms of~     treatment discontinuation) than others. Most of the medium-term randomized studies have~     shown similar rates of all-cause treatment discontinuation in first episode patients treated~     with different SGAs. It may be concluded that more randomized controlled trails should be~     accomplished to determine the position of frequently used SGAs in clinical practice.~     Investigators undertook this study with the major objective of comparing the clinical~     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in~     the acute treatment of first-episode non-affective psychosis individuals at 3 years of~     follow-up.~   "
40567|NCT02526004|"~     Antimicrobial resistance is a significant challenge facing global healthcare. The~     unnecessary use of antibiotics is a key driver in the development of antibiotic resistance.~     Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to~     explore therapeutic strategies for same, as chronic lung infection overlaps with acute lung~     exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial~     infection develops, with the most dominant infecting organism being Pseudomonas aeruginosa.~     In acute CF infections, empiric intravenous antibiotics are usually given for two weeks.~     Recurrent infections and treatments result in increasing antimicrobial resistance, and~     alterations in pathogen host interactions in the lung and gut flora. Next-generation DNA~     sequencing technology now offers DNA-based personalised diagnostics and treatment~     strategies. Enhancing our knowledge of the microbiome allows the use of stratified targeted~     antibacterial therapy that can be compared with standard empirical antibacterial therapy~     currently used. Cystic Fibrosis Microbiome-determined Antimicrobial Therapy Trial in~     Exacerbations: Results Stratified (CFMATTERS) will provide a randomized multi-centre~     controlled trial of microbiome-derived antimicrobial treatments versus current empirical~     therapy.~   "
40568|NCT02525991|"~     Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted~     in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety~     profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when~     self-administered outside of a hospital setting without the supervision of a healthcare~     professional. The Study will aim to include approximately 500 patients who have been~     previously treated with ADASUVE® in the last 6 months prior to screening or recently treated~     during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE®~     responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about~     30-34 centers. All patients will be followed up for a maximum of 6 months from baseline,~     during which it is expected that a new episode of agitation will occur.~   "
40569|NCT02525978|"~     The purpose of this study is to understand if there is a relationship between the way that~     emotions are regulated by the brain and the way that heart rate is regulated by the brain.~     The study also seeks to understand whether having depression changes the way that emotions~     and heart rate are regulated.~   "
40570|NCT02525965|"~     Before the surgery, the investigators predict the risk of microvascular invasion (MVI)~     presence for the early-stage hepatocellular carcinoma according to the nomogram the~     investigators have created. Patients with a high risk of microvascular invasion were~     randomly chose to give the treatment of a wide resection margin, which establish an~     individualized anti-recurrence program based on the high-grade evidence-based medicine.~   "
40571|NCT02525952|"~     The aim of this study is to establish a selection criteria of hepatectomy for patients with~     multiple hepatocellular carcinomas based on the NDR Scoring System~   "
40572|NCT02525939|"~     A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study~     in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects~     will provide informed consent before any study-specific procedures are performed. Subject~     enrollment may begin in the hospital and will continue following release from the hospital.~     Screening procedures may be performed at the time of the index ACS event or anytime~     thereafter, with the condition that randomization must occur within the mandated window~     (4-12 weeks after the index event). Subjects will be assessed based on their medical~     history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate~     genetic determination for the presence of AA genotype.~   "
40573|NCT02525926|"~     Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and~     premature death. Only modest improvements of outcomes have been observed with the current~     available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also~     expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot~     study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical~     improvement in 13 patients with severe pulmonary hypertension despite optimal medical~     management. However this single non-randomized study requires confirmation.~      The investigators propose a prospective multi-center, randomized, single-blinded trial. Its~     main objective will be to assess, in patients with uncontrolled pulmonary hypertension~     despite optimal medical management, the efficacy of pulmonary artery denervation in reducing~     mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment~     following a simulated (sham) procedure.~      The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right~     heart catheterization.~      The study will run for 18 months and it will be necessary to recruit 50 patients.~      All adult patients (with the exception of pregnant women and individuals unable to receive~     an appropriate information and to give their free and informed consent) with uncontrolled~     pulmonary arterial hypertension despite optimal medical management will be invited to~     participate, in the absence of any exclusion criteria.~      The investigators will also measure changes in clinical, biological, echocardiographic and~     hemodynamic prognostic markers in both groups.~   "
40574|NCT02525913|"~     The purpose of this study is to build a device that will consistently ablate (destroy or~     remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the~     tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to~     handle, perform the ablation in less time and by so ablating this margin would avoid the~     need in many for reoperation to obtain negative margins and based on preliminary data avoid~     the need for radiation. This would be especially important in poor and rural patients and~     would lead to decreased costs of treatment in patients with favorable breast cancer.~   "
40575|NCT02525900|"~     Prospective, randomized study comparing local wound infiltration with local anesthetic (LA)~     versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths)~     catheters with LA for treatment of postoperative pain after total abdominal hysterectomy~     (TAH).~   "
40576|NCT02525887|"~     This observation will look at patient care decisions of the primary healthcare provider~     utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9,~     2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1. Findings of the data collection will be~     published to optimize the benefits of pharmacogenomics testing and publish health outcomes.~   "
40577|NCT02525874|"~     The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset~     counts during the first year of treatment in subjects with relapsing-remitting multiple~     sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on~     absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of~     treatment.~   "
40578|NCT02525861|"~     The purpose of the study is two-fold: (1) to further evaluate the safety and potential~     immunogenicity of GLASSIA following IV administration via in-line filtration; and, (2) to~     assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various~     biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at~     a dosage of 60 mg/kg Body weight (BW)/week active A1PI protein for 25 weeks in subjects with~     emphysema due to congenital A1PI deficiency.~   "
40579|NCT02525848|"~     To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin~     prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic~     gynacological surgeries.~   "
40580|NCT02525835|"~     This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na)~     magnetic resonance imaging-determined skin sodium concentrations in patients with systemic~     lupus erythematosus (SLE) and improve blood pressure and inflammation~   "
40581|NCT02525822|"~     The primary objective of this study is to compare the safety and efficacy of once daily~     application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in~     subjects with moderate to severe acne vulgaris.~   "
40582|NCT02525809|"~     The total hip replacement, with over 120,000 cases per year in France, provides short term,~     excellent functional results and a significant improvement in quality of life, in almost all~     cases. However, observation showed that the dislocation is not a rare complication (2-4%)~     and the lifetime of the implants is limited due to aseptic loosening.~      The evaluation process used in this study will be the extent of penetration of the metal~     femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA)~     whose precision provides early results (2 3 years), long before wear and migration are~     measurable by conventional radiological means. The main objective will be to compare, 2~     years after the intervention, the penetration of the metal femoral head in 3 types of~     inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit~     pure (Sunfit®), and a fixed insert (Quartz®).~      This is a randomized controlled trial. 105 patients will be enrolled (35 in each group).~     Patients will be included in each of the two participating centers (Amiens, Caen). The~     analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will~     be made to 3 years if the analysis requires it to 2 years.~      Analysis of pictures will be centralized in Caen and performed with specific software after~     transferring images via a secure network.~   "
40583|NCT02525796|"~     This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in~     combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium~     levels in primary hyperparathyroidism.~   "
40584|NCT02525770|"~     Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the~     few early complications (acute infections and dislocations), the patient made a PTH can be~     assured of a significant improvement in its function and its short-term quality of life.~     However, clinical studies and records have shown that the lifetime of these implants was~     limited. The main cause of failure is the aseptic loosening influenced by many factors,~     foremost of which is due to periprosthetic osteolysis debris. This is a major concern for~     orthopedic surgeons loosening leads, in most cases, the recovery, the importance of~     osteolysis is a major cause of difficulties and poorer results.~      The main objective of the study is to compare, 2 years after the intervention, the~     penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC®~     conventional polyethylene.~   "
40585|NCT02525757|"~     The goal of this clinical research study is to learn about the safety of adding MDPL3280A to~     standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in~     patients with lung cancer.~   "
40586|NCT02525744|"~     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect~     of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be~     documented. The study will last for about 8 to 9 weeks for each participant, including~     screening and follow up. Screening is required within 28 days prior to entering the study.~   "
40587|NCT02525731|"~     The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on~     chronic opioid therapy (COT) by describing basic demographics and health status, including~     characteristics of pain (severity and interference), aberrant behaviors/misuse of COT,~     substance use and trust/satisfaction with providers. In addition, data on a subset of~     participants will be used to supplement analysis of secondary outcomes for the TEACH~     randomized controlled trial (RCT), an intervention study directed at COT providers (outlined~     in a separate Clinical Trials Protocol Registration and Results (PRS) summary).~   "
40588|NCT02525718|"~     Subjects are being asked to participate in this study because they will be undergoing~     unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction~     involving insertion of a tissue expander.~   "
40589|NCT02525705|"~     The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping~     syndrome in children operated at birth for oesophageal atresia type III et IV.~   "
40590|NCT02525692|"~     ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory~     studies and successfully completed a phase I clinical trial in advanced cancer patients.~     This clinical trial will be the first phase II clinical trial of ONC201 that will~     specifically enroll patients with advanced glioblastoma.~   "
40591|NCT02525679|"~     The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy~     male subjects following single rising low, medium and high doses.~   "
40592|NCT02525666|"~     Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh~     covering both groins. Health outcomes are assessed using different questionaires with focus~     on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain~     measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for~     12 months.~   "
40593|NCT02525653|"~     The purpose of this study is to test the safety and effectiveness of albumin-bound~     paclitaxel plus gemcitabine in patients with advanced squamous cell lung cancers. The~     investigators would like to determine the percentage of patients with squamous cell lung~     cancers who experience shrinkage of their tumors following treatment with this regimen. This~     combination of drugs is not a standard therapy for patients with squamous cell lung cancers.~     However, each of these drugs, when given alone or with other chemotherapies, is FDA-approved~     for the treatment of this disease.~   "
40594|NCT02525640|"~     Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a~     significant worsening of hearing in one ear compared to the other.~      In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular~     schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new~     SSD patients being referred every year.~      Only a small number of studies have explored hearing handicap for those with SSD, and music~     appreciation has not been investigated, to the best of the investigators knowledge, in this~     patient group.~      In the limited number of studies conducted on those with single sided deafness, often only~     one or two outcome measures have been used, or the patient group has been small. The~     investigators have a large group of patients with a wide range of aetiologies who have~     completed several questionnaires as part of their treatment in the single sided deafness~     clinic and the investigators would like to analyse these data.~      At present there are different devices available on the NHS for the management of SSD and~     many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an~     under-representation of studies looking specifically at CROS aid devices which is relevant~     given the cost differences involved between devices.~      Study goals and objectives~        -  To find out what factors drive hearing handicap in SSD patients by analysing the~          results of several different well validated hearing handicap questionnaires~        -  To find out whether or not it is possible to change hearing handicap in this patient~          group by looking to see if there is an improvement in questionnaire scores post~          treatment.~        -  The investigators will also look at a sub-group who will be fitted with both~          traditional wired CROS aids and more up-to-date wireless aids which have been funded~          through a research grant, in order to assess whether these are more beneficial.~        -  The investigators will use a new questionnaire developed in-house to further explore~          the impact of single sided deafness on music appreciation.~   "
40595|NCT02525627|"~     Prospective, singlecentre, randomized clinical study; series of patients with a 5-years~     patient evaluation period.~   "
40596|NCT02525614|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a~     prospective randomized clinical trial.~   "
40597|NCT02525601|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a~     prospective randomized clinical trial.~   "
40598|NCT02525588|"~     Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with X3 highly~     cross-linked polyethylene in a CS (condylar stabilizing) fixed bearing total knee prosthesis~     by means of RSA and clinical evaluation.~   "
40599|NCT02525575|"~     For suicidal individuals, minimizing future risk and fostering recovery are critical public~     health concerns, especially among Veterans, as very few effective interventions exist. This~     proposal tests a novel group psychotherapy treatment that combines emotion regulation skill~     based, and psychoeducational approaches, with suicide safety planning development and~     implementation.~      Project Life Force (PLF), a novel suicide safety planning group intervention has been~     designed to fill this critical gap and provide a mechanism to develop and enhance suicide~     safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines~     Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to~     enhance suicide safety planning development and implementation. Veterans revise their plans~     over several weeks while learning distress tolerance, emotion regulation, and friendship~     building/interpersonal skills to incorporate into their safety plans and also receive~     lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1)~     training in the use of a suicide safety planning mobile App to promote accessibility and~     maximize implementation, and 2) didactic information to bolster recovery, including~     fostering improved connection with the treatment team, and Veteran's family.~   "
40600|NCT02525562|"~     Provide outcomes information with regard to surgical and implant performance and patient~     clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty~     (TKA) replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty,~     UKA)~   "
40601|NCT02525549|"~     The purpose of this study is to compare the safety and bioequivalence of Perrigo's product~     to an FDA approved product for the treatment acne vulgaris.~   "
40602|NCT02525536|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK)~     profile of trebananib (AMG 386) after intravenous administration in adult Japanese~     participants with advanced solid tumors.~   "
40603|NCT02525523|"~     A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic~     antibiotic refractory pouchitis.~      Subjects will undertake a <2 week screening period to provide baseline data and be assessed~     for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1~     basis to either a) 240 mg alicaforsen enema or b) matching placebo.~      Study drug will be administered once nightly (on going to bed) up to and including week 6.~     Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy~     assessments at Week 3, 6, 10, 18 and 26.~      Subjects may receive certain permitted medications as per Entry Criteria, which must remain~     at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a~     dose change to an existing concomitant medication for pouchitis, other than those detailed~     in the protocol, will not be permitted.~      Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary~     card.~      Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks~     6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy~     sample for histopathology.~      In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will~     be assessed.~      Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods~     and stool samples will be collected to evaluate relevant biomarkers.~   "
40604|NCT02525510|"~     To protect kidney function during the transplantation process by comparing mild hypothermia~     in the deceased organ donor before organs are recovered and pulsatile perfusion of the~     kidney while being transported to the recipient.~   "
40605|NCT02525497|"~     This study is a randomized, multi-center，crossover study of a domestic FM peritoneal~     dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and~     manipulability of a domestic peritoneal dialysis machine.~   "
40606|NCT02525484|"~     This is a Phase I, open-label, randomized, four-treatment period, four-sequence,~     single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone~     after administration of tablet and capsule dosage forms under both fed and fasted~     conditions.~   "
40608|NCT02525458|"~     One of the major challenges in orthodontic treatment is long-term stability. Because~     removable retainers are worn for at least one year, bacteria and fungi may accumulate on the~     retainers in the form of multi-species plaque biofilms. This may result in increased~     incidence of proximal dental caries or oral candida infection. Thus, incorporation of~     antimicrobial activity in orthodontic acrylic resin to achieve plaque biofilm reduction is~     highly desirable. An antimicrobial and antifungal quaternary ammonium methacryloxy silicate~     molecule (QAMS) has been synthesized by sol-gel reaction and incorporated into orthodontic~     acrylic resin. The QAMS-copolymerized acrylic resin demonstrated contact-killing properties~     against single-species biofilms in previous in vitro studies and has received US FDA 510(K)~     clearance for marketing. The objective of the present randomized clinical trial is to~     determine the in vivo antimicrobial efficacy of the QAMS-containing orthodontic acrylic by~     using removable retainers that are worn by recruited subjects to create 48-hour~     multi-species plaque biofilms. The null hypothesis tested is that there is no difference in~     the antimicrobial activities between QAMS-free and QAMS-containing orthodontic acrylic resin~     on oral biofilms grown in vivo in human subjects.~   "
40609|NCT02525445|"~     The purpose of this study is to investigate if it is possible to influence the participants'~     expectations to improve outcome, in this particular setting the relaxing effects of one~     single acupuncture treatment with genuine or sham needles combined with positive or neutral~     communication regarding expected relaxing effects.~   "
40610|NCT02525432|"~     The purpose of this study is to determine the effect of intravenous infusion of autologous~     bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional~     outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to~     determine if the intravenous infusion of autologous BMMNC after severe TBI results in~     structural preservation of global gray matter (GM) volume and white matter (WM) volume and~     integrity; as well as select regions of interest in the corpus callosum. THe secondary~     objectives are to determine if autologous BMMNC infusion improves functional and~     neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI;~     evaluate spleen size and splenic blood flow over time using ultrasound and corresponding~     changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up~     safety evaluations.~   "
40611|NCT02525419|"~     This study systematically quantified the effects of intermittent fasting and caloric~     restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat~     mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate~     utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants~     were enrolled in the study as a single cohort and participated in an 12-week trial~     consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase~     (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were~     required to maintain their body weight by consuming their normal food intake; however,~     during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to~     result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight~     loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up~     study. If they agreed to participate, groups were balanced so there were similar numbers of~     men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation)~     included: 1) a modified version of the 12 week weight loss intervention that consumes whole~     foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet~     similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of~     Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the~     duration of 12 months.~   "
40612|NCT02525406|"~     The goal of the study is to identify factors that enhance productivity and increase value~     delivered by hospitals drawing on concepts used in industry for quality and productivity in~     production and operations management literature. The investigators intend to look at surgeon~     experience, patient characteristics and pre-admission testing on operating room~     productivity.~   "
40613|NCT02525393|"~     Patients were randomized in 3 groups: two intervent groups and a control group. The first~     group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation~     (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct~     Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS~     and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily~     session of sham tDCS.~      Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were~     performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all~     patients underwent follow-up neuropsychological assessment 6 months after the end of each~     stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of~     each stimulation period.~   "
40614|NCT02525380|"~     Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced~     hepatocellular carcinoma.~   "
40615|NCT02525367|"~     In Parkinson's disease, Multiple Sclerosis and depressed patients treated with~     electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these~     dysfunctions is in its infancy.~      The purpose of this study is 1) to assess the feasibility of a randomized controlled trial~     using an online computerized intervention for training cognitive abilities in the three~     patient groups and 2) to estimate the effect of the online training on objectively and~     subjectively measured cognitive functions.~      The investigators hypothesize that patients using online cognitive training will improve~     more on cognitive functions, as compared to patients using an active control condition.~   "
40616|NCT02525354|"~     Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence~     of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. The~     purpose of the present study was to test the hypothesis that the relationship between~     obesity and atopic-related respiratory disease in premenopausal women is mediated by a~     dietary imbalance of omega 6 and 3 polyunsaturated fatty acids.~   "
40617|NCT02525341|"~     The purpose of the study is to examine the short and long term effects of Hatha yoga~     compared to the current recommended exercise program in promoting physical function,~     alleviating osteoarthritis (OA)-related symptoms, fear of falling, and improving mood,~     spiritual health, physical activity level, and quality of life in older adults with knee OA,~     and to determine the effect sizes for use in power calculations to design a larger efficacy~     clinical trial.~   "
40618|NCT02525328|"~     Constitutional thinness (CT) is a recently defined entity as a differential diagnosis of~     anorexia nervosa (AN), considered to be the most frequent cause of low body mass index (BMI)~     in young women. CT subjects present no AN psychiatric traits, preserved menses, no~     biological signs of undernutrition and balanced energy metabolism despite a Body Mass Index~     (BMI) <17 kg / m².~      CT familial aggregation, low body mass without a hormonal explanation, and specific appetite~     regulation profile suggest a specific genetic profile in these subjects.~      Objective: A family linkage study in order to identify genes involved in the constitutional~     thinness phenotype by using genome wide scan (GWAS) techniques Studied population: Fifty~     families including at least one well phenotyped CT index case (grade 2 or 3 of thinness~     according WHO classification). Blood or saliva is sampled for DNA extraction.~      Perspectives: Revealing eventual abnormalities could lead to a more precise diagnosis of~     constitutional thinness and new hypothesis in understanding extreme bodyweight mechanisms.~   "
40619|NCT02525315|"~     Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating.~     Behavioral disorders associated with them can have serious social repercussions. However, in~     25% of cases the usual antipsychotic drug treatments are incompletely or totally~     ineffective.~      Fifteen subjects will be included after collection and signed their informed consent.~      The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency~     of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to~     stay below the risk of occurrence of seizures, the only serious side effects identified.~     Furthermore the rTMS treatment is almost painless: tension headaches are the main side~     effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects.~     The LEFT stimulation site will be established through a anatomofunctional imaging before~     treatment (between D-7 and D0).~      Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the~     first 2 weeks of starting treatment.~   "
40620|NCT02525302|"~     This study, HALO-DMD-03, is a follow-on study to HALO-DMD-01 and HALO-DMD-02, and allows~     continued open-label access to HT-100 for subjects who have completed these studies.~     HALO-DMD-03 will provide safety and strength and function data on continuous long-term~     dosing. Data from this study will be used to inform the safety, tolerability, and dose~     selection for a future trial of HT-100 in boys with Duchenne Muscular Dystrophy (DMD).~   "
40621|NCT02525289|"~     To investigate different strategies of body positioning associated to early corporal~     mobilization and verify the impact int the time and quantification of thoracic and~     mediastinal drainage, pulmonary complications and time of intensive care units in hospitals~     stay. After first six hours post extubation in the first postoperative day and after~     evaluation and inclusion in the study, patients were randomized in three groups for~     receiving different strategies of body positioning associated to early mobilization with~     help of bed Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous~     Lateral Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT~     n=34).~   "
40622|NCT02525276|"~     The main objective of this study is to investigate the role of female sex hormones in~     relation to insulin resistance in a controlled human experimental model of menopause and to~     explore whether exercise and/or hormone treatment (HT) can compensate for loss of endogenous~     sex hormone production by maintaining insulin sensitivity and metabolic activity at a level~     equivalent to what is seen in premenopausal women.~      Loss of ovarian function is associated with an increased incidence of metabolic disease~     including metabolic syndrome, type 2 diabetes and cardiovascular disease. This increased~     disease incidence seems to be related to changes in body composition including decreased~     skeletal muscle mass and increased visceral fat mass as well as decreased whole body fat~     oxidation and energy expenditure. Regular physical activity decreases general mortality~     among other things by increasing fat free mass and insulin sensitivity and hereby prevents~     metabolic syndrome and cardiovascular disease - conditions seen with an increased incidence~     after menopause and could therefore be a possible treatment.~      In the present study the Investigators will assess the role of sex hormones in a model of~     menopause where healthy women are undergoing planned bilateral oophorectomy due to risk of~     hereditary ovary cancer. The use of this model makes it possible to control the time point~     for loss of ovarian function and hereby investigate the timeframe and possible contributing~     factors in a strictly controlled model. 48 premenopausal women will be included in the~     study. The study is conducted in women who have already been offered surgical oophorectomy.~     The first 2 months the study will be an observational cohort study. Hereafter the patients~     will be allocated to one of four groups (n=12) in a randomized controlled trial, addressing~     the effects of 6 months of exercise with or without HT. Type of surgery has been decided~     before inclusion based on medical indications. The women will be offered HT according to~     national guidelines, but the choice is up to them. Randomization applies only to the~     training intervention.~      Firstly the Investigators aim at investigating the role of endogenous female sex hormones~     and HT in relation to insulin resistance, whole body fat oxidation and -energy expenditure,~     changes in visceral fat mass and fat free mass after oophorectomy. Secondly, the~     Investigators wish to study the molecular mechanisms behind the oophorectomy-induced insulin~     resistance with a focus on insulin signaling in skeletal muscle and fat tissue. Lastly, the~     investigators aim to explore whether exercise and/or HT can compensate for loss of~     endogenous female sex hormone production by maintaining IS and metabolic activity, hereby~     preventing future incidents of metabolic disease in relation to menopause.~      All in all, this project will contribute with new knowledge concerning the question of how~     endogenous female sex hormones affect insulin sensitivity and metabolic functioning and how~     exercise may be used as a disease preventive modality for middle-aged women.~   "
40623|NCT02525263|"~     A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA)~     in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from~     expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy.~     All enrolled subjects will be treated with up to two injections of NKA at least 6 months~     apart.~   "
40624|NCT02525250|"~     This project is a framework for developing new therapeutic strategies for acute myeloid~     leukemia(AML)based immunotherapy.~      the role of NK cells was demonstrated in AML and especially GVL effect (graft versus~     leukemia) during allogeneic transplantation in these patients. However, it has been shown~     that the phenotype of NK cells and their cytotoxic functions were altered during this~     malignancy. In addition, in these patients, impaired NK function is associated with relapse.~      lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a~     role in leukemic cells in this malignancy? what is its effect on the production of~     pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of~     NK cells from healthy donors and patients with LAM, and despite these phenotypic changes,~     the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase~     in the production of TNF-alpha (tumor necrosis factor) by NK.~      It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this~     study confirm these results in vivo in peripheral blood cells in patients treated with~     lenalidomide.~   "
40625|NCT02525237|"~     The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with~     S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction~     adenocarcinoma.~   "
40640|NCT02525042|"~     The main objective is to identify in the candidate regions of differentially expressed genes~     by comparing the transcriptome of dendritic cells derived from circulating monocytes between~     cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and~     depending on haplotype association studies to correlate the differences of gene expression~     and genetic variations with susceptibility to AS.~   "
40626|NCT02525224|"~     Healthy skin has been equated with a healthy diet leading to the inside out approach to~     skin health. Since the skin is the barrier to the external world, healthy skin should lead~     to overall better health. Conversely, the skin derives its nutrition from the internal body~     requiring the consumption of nutritional supplements for optimal health. This research~     attempts to examine skin attributes and improved appearance achieved after consumption of a~     state-of-the-art dietary supplement.~   "
40627|NCT02525211|"~     The acute pain care, in particular after breast cancer surgery must be early and quickly~     effective, because a severe postoperative pain increases the risk of chronic pain and~     exposes to a risk of important embarrassment for the realization of simple daily movements.~      Associated to conventional analgesics administered by systemic way, a local anesthesic~     (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the~     operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the~     surgical unit by the surgeon at the end the surgical procedure.~      Besides the control of the postoperative acute pain, the local anesthesic could intervene in~     the prevention of the chronic pain, the early recovery, the reduction of the neuropathic~     pains and the decrease of needs in morphine after mastectomy.~      The duration of hospitalization being lower than 48 hours for this type of surgery, the~     investigators envisage an immediate follow-up in the Units of Care then at home, what will~     require a training of the hospital actors and at home (patient, family, visiting nurse,~     general practitioner).~      Although proposed for several years, the CCP after breast surgery is still a little spread~     technique and few works had evaluated the pain at rest and at mobilization after mastectomy,~     the early rehabilitation, and to spread its use towards home, that is why we propose a~     randomized double-blind study ropivacaine / placebo in patients after mastectomy.~   "
40628|NCT02525198|"~     There is a dearth of research which takes a multi-compound approach to dietary~     interventions, in humans, aimed at improving outcome measures of cognition. Animal research~     in particular points towards fatty acids and flavonoids having a potentiating effect on each~     other, and possibly even being synergistic. Thus, study products will be administered in the~     present trial comprising both of these compounds, with a view to investigating their~     potential effects on cognition in older adults with mild cognitive impairment (MCI) or~     subjective memory impairment (SMI).~   "
40629|NCT02525185|"~     Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in~     patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT~     are non-responders. In this study the investigators will use a previously validated method~     to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and~     blood pressure. Since segments which shorten in systole perform positive work, whereas~     segments which lengthen do negative work, the investigators will calculate wasted work as~     negative work in percentage of positive work. The main purpose of the study is to determine~     if wasted work can predict response to CRT.~   "
40630|NCT02525172|"~     The purpose of this study is to assess anti-recombinant human acid α-glucosidase~     (anti-rhGAA) antibody titers after treatment with immune modulation therapy in patients of~     Pompe disease.~   "
40631|NCT02525159|"~     Breast cancer is a public health problem in Mexico and its incidence rises when the woman is~     still premenopausal. Estrogen metabolism has been linked to breast cancer. Several studies~     reported that high concentrations of 2 hydroxyestrone (2OHE1) in urine have a protective~     effect for this neoplasia, whereas high concentrations of 16 alpha-hydroxyestrone (16αOHE1)~     in urine have the opposite effect, further has been reported that women with a ratio of~     estrogen metabolites 2OHE1:16αOHE1 in urine (REMU) less than 0.9, have ten times the risk of~     developing Breast Cancer than those women with an RMEU equal or more than 0.9. Other studies~     have showed that the active compounds of cruciferous vegetables, indole-3-carbinol (I3C) and~     its dimer, 3'3'diindolylmethane (DIM) induce benign pathway of metabolism of estrogens~     producing 2OHE1. Several studies, evaluate the pharmacokinetics and effect of I3C~     supplementation, finding that 300 to 600 mg of this compound are well tolerated and able to~     promote formation of 2OHE1 in women when supplemented for one month. In the case of DIM,~     only a pilot study has explored its effect in postmenopausal women with personal history of~     breast cancer in early stages, reporting an increase in the concentrations of 2OHE1. The~     purpose of this study was to evaluate the effectiveness of supplementation with DIM to~     increase urinary RMEU in premenopausal women at risk of Breast Cancer (RMEU less than 0.9).~     A clinical, randomized, double-blind study was performed with women attending on the~     urogynecology service of Institute National of Perinatology. Subjects were premenopausal~     women over 34 years who were healthy. The inclusion criteria's was had a RMEU less than 0.9~     and were excluded for any medical condition, medication, or dietary or lifestyle habit that~     might interfere with estrogen metabolism. Patients were randomly assigned to one of two~     groups: one received orally at a daily dose of 75 mg of DIM for a period of 30 days and~     other group received orally at a daily placebo for a period of 30 days. All urine samples~     were collected from the women before DIM or placebo ingestion, after 30 days of DIM or~     placebo ingestion and finally after another 30 days once suspended supplementation. Analysis~     of the 2OHE1 and 16αOHE1 were determined using a commercially kit ESTRAMET™. The change in~     metabolites median concentrations and RMEU was assessed through the Wilcoxon test and these~     differences between groups through U Mann-Whitney test.~   "
40632|NCT02525146|"~     The purpose of this study is to determine whether a modified form of the ARTAS~     (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who~     have fallen out of care, can be successful in re-engaging patients in care and reducing~     HIV-1 viral load.~   "
40633|NCT02525133|"~     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral~     inguinal hernioplasty via open laparotomy (tension-free technique).~      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical~     rating scale (NRS) from 0 hour through 72 hours postoperatively.~      The expected maximum study duration for each patient will be up to 60 days, including a~     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post~     implantation period including treatment and follow-up.~   "
40634|NCT02525120|"~     The primary objective of this study is to compare the early clinical outcomes following~     non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less~     than or equal to 6 months.~   "
40635|NCT02525107|"~     140 SCD patients [70 on Hydroxyurea] will receive Omega-3 capsules whereas another 140 SCD~     patients [70 on Hydroxyurea] will receive placebo and will be recruited from the Sultan~     Qaboos University Hospital [SQUH] haematology specialty clinics. Patients will be randomized~     in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the~     therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in~     Omani patients with sickle cell disease[SCD].~   "
40636|NCT02525094|"~     To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis~   "
40641|NCT02525029|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when~     given in combination with standard immunosuppressive therapy in pediatric and adult patients~     with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.~   "
40642|NCT02525016|"~     Intravenous lidocaine is efficient for management of post operative pain in abdominal~     surgery. As previously published in literature the investigators use it during bariatric~     surgery.~      Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a~     widespread use.~      Investigators propose in this work to bring an objective proof that administration of~     lidocaine based on a modified body weight is safe.~      Intravenous administration concerned the peri operative period. A total of six samples are~     taken for each patient.~      Investigators get approbation of local ethic committee for this work.~   "
40643|NCT02525003|"~     Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However,~     in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in~     winter. Between November and March, dietary or supplementary vitamin D intake is essential~     to maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a~     few natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of~     vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2~     (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one~     strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly~     used in fortified products in Europe, although the production of plant-derived vitamin D2~     would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3~     are limited. An important consideration is whether food-based sources of vitamin D2 are~     effective in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The~     investigators investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast~     in bread in terms of efficacy of raising total S-25(OH)D) as well its possible effects on~     S-25(OH)D2, S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations~     compared with D2 and D3 supplementation in a randomized placebo-controlled trial in young~     healthy females during winter in Finland.~   "
40644|NCT02524990|"~     The purpose of this operations research study is to evaluate women's interest in and~     compliance with using a semiquantitative multi-level dipstick pregnancy test at home for~     medical abortion follow-up.~   "
40645|NCT02524977|"~     Study objective was to improve decision-making and thromboprophylaxis for patients with~     Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool~     for individual patient-level decision-making about oral anticoagulant therapy. To accomplish~     these goals, the investigators studied the incremental impact of adding a~     quality-improvement (QI) intervention to an educational package (for practice staff and~     clinicians) using a computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST)~     for individual patient-level decision-making about oral anticoagulant therapy in patients~     with non-valvular AF. The decision support tool incorporates individual patients' risk~     factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment~     based upon the projected quality-adjusted life expectancy gained or lost with the addition~     of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.~   "
40646|NCT02524964|"~     Approximately 60 patients with ST-segment elevation myocardial infarction successfully~     treated with primary percutaneous coronary intervention will be enrolled and randomized to~     receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same~     volume/day of normal saline.~      The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed~     with cardiac magnetic resonance imaging (MRI) at baseline and 6 months.~   "
40647|NCT02524951|"~     This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a~     single intravenous infusion twice a week for 3 weeks on a 4-week cycle.~   "
40648|NCT02524938|"~     Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with~     high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and~     an increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may~     improve renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of~     the principle polyphenol groups in the diet - coffee/tea, stone fruits (especially~     plums/prunes) and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been~     associated with 25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure,~     and oxidative stress levels. This randomised controlled trial, therefore, aims to evaluate~     the effect of high CGA food on glycation and oxidative stress in T2DM subjects with early~     renal insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of~     renal insufficiency and the risk of cardiovascular diseases.~      The study will have two phases - phase I, an interventional study of 3 months followed by~     phase II, an observational study of 21 months.~      In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control~     (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich~     food (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4~     coffee cups per day) for 12 weeks. The control group will receive a conventional coffee low~     in chlorogenic acid.~      Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At~     baseline, general information, medical history, dietary habits and medication use will be~     recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be~     collected and blood pressure, waist circumference, height and weight recorded. Participants'~     diet over the previous 3 days will be assessed by estimated food diary analysis.~      In phase II, written dietary recommendations will be provided at three time points (months~     6, 12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at~     least 1g per day, and at least 400mg per day of CGA) and standard dietary advice for the~     control group. Anthropometric/dietary data will be collected as well as blood and urine~     samples to assess markers of renal function, glycation and oxidative stress, and proteomic~     markers of cardiovascular disease, coronary artery disease and diabetes.~   "
40649|NCT02524925|"~     A prospective randomized clinical study, with cross-sectional comparisons and correlations~     was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone~     hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied~     postoperatively the protocol Fast-track, while in group B the conventional postoperative~     care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY),~     Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a)~     at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or~     prior to discharge.~   "
40659|NCT02524795|"~     Omega-3 fatty acids have been considered anti-inflammatory lipids based on data from~     epidemiological studies of Greenland Eskimos whose diet is rich in fish, sources of~     polyunsaturated fatty acids.~      Fatty acids from the omega-3 family [mainly the α-linolenic acid, eicosapentaenoic (EPA) and~     docosahexaenoic (DHA)], as well as those of the omega-6 family [represented mainly by~     linoleic acid and arachidonic acid (AA)] are essential for the synthesis of eicosanoids,~     prostaglandins, leukotrienes, thromboxanes and other oxidative factors, major mediators and~     regulators of inflammation.~      Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease characterized by~     the loss of balance of cellular immunoregulation and increased levels of circulating~     inflammatory mediators.Thus, omega-3 supplementation could represent additional therapy for~     individuals with SLE.~      The aim of this study was to investigate the effects of omega-3 fatty acids on circulating~     levels of inflammatory and biochemical markers in women with SLE.~   "
40650|NCT02524912|"~     Methadone maintenance treatment (MMT) has been one of the most effective treatment choices~     for opioid addicts to reduce their heroin use, criminality and spread of HIV. In Taiwan, MMT~     has been introduced since 2006. To date, more than 30,000 opioid addicts have ever~     participated in MMT, but only around 10,000 retains in treatment. Outcomes of the~     ever-treated MMT patients remain unclear. It is crucial to trace the opioid addicts'~     treatment career, outcomes and unmet treatment needs for the service providers to modify~     treatment strategy to help these individual to maintain abstinence. Moreover, understanding~     of the determinants for these subjects' long-term outcomes is important for policy makers to~     implement realistic policies to motivate the service providers and patients.~      From the results of previous research, the research team found that early dropout, defined~     as stayed in-treatment less than one month, of MMT participants were 14.4%. The rate of~     maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%,~     respectively. Average treatment days for 12-month is 186.9±141.2. This result showed that~     the effectiveness of the MMT was varied among different facilities. On the other hand, the~     quality of the MMT can be improved largely through different dimensions. Besides, if one~     participant can enhance its motivation in staying in-treatment, it could reduce 15% early~     dropout. Above all, the result also showed that though the quality of life was recorded as~     improved after MMT, it appeared to be significantly lower than their healthy counterparties.~     The assessments of health outcomes after participating MMT are rare, but in need. It is~     necessary to make some modification to improve the effectiveness. Moreover, the evaluation~     of the needs shall not limit to patients, but also extend to their family members.~      Therefore, in this study, the research team plans to probe the dimensions from physical,~     psychiatric, to social conditions by assessing patients and their family members after~     treated by MMT for five years. The research team would like to know more about the outcomes~     of those who attended MMT five years ago, their physical and mental health conditions, also~     health status of their family members.~   "
40651|NCT02524899|"~     This is a study to assess the efficacy augmenting cognitive remediation therapy (CRT) with a~     pharmacological agent for individuals with schizotypal personality disorder (SPD). Impaired~     cognition, along with functional and social skill deficits, is a core feature of~     schizophrenia and schizophrenia spectrum disorders. A better understanding of the cognitive~     and functional impairments in schizophrenia-related conditions, as well as the~     identification of interventions that can reduce these impairments, are vital to improving~     outcomes for individual with these disorders.~   "
40652|NCT02524886|"~     Rationale: Tardive dyskinesia and dystonia (TDD) are severe side effects of dopamine~     blocking agents, particularly antipsychotics. Deep brain stimulation (DBS) has shown to be~     effective in the treatment of TDD in psychiatric patients, but only reported in case reports~     and small clinical trials and with little attention to possible psychiatric or cognitive~     complications or positive effect on psychiatric symptoms.~      Objective: To assess whether treatment with DBS can reduce or resolve TDD and if DBS can~     induce beneficial or side-effects in particular psychiatric symptoms.~      Study design: A delayed onset double blind randomised controlled trial. Study population:~     Adult patients with a current or previous psychiatric disorder and antipsychotic induced TDD~     with a stable psychiatric status during the past 6 months.~      Intervention: All patients will be treated with DBS in the posteroventrolateral GPi. The~     groups will be randomised into immediate stimulation or delayed stimulation after 3 months.~      Main study parameters/endpoints: Primary objective, improvement on the movement rating~     scales BFMDRS. Secondary objectives improvement on the quality of life measured on the~     SF-36, psychiatric stability as measured on the BPRS and the MADRS and cognitive effects as~     measured on the MATTIS Dementia Rating Scale, Nederlandse Leestest voor Volwassenen (NLV),~     15 word test, Facial Expression of Emotion S+T (FEEST), Groninger Intelligentie Test~     woordopnoemen (GIT), category and letter fluency test, Trail Making Test part A and B and~     the Stroop colour and word test~   "
40653|NCT02524873|"~     Whether patients with a functional genotype of a protein important in blood pressure~     regulation respond better to a drug therapy class/combination of therapy classes that target~     that specific pathway using the Geneticure panel for high blood pressure~   "
40654|NCT02524860|"~     The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting~     clinically significant prostate cancer in a standard clinical environment.~   "
40655|NCT02524847|"~     This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen)~     Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems in pediatric~     patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and~     Follow-up Periods.~   "
40656|NCT02524834|"~     This is an early feasibility study that investigates the outcome of selected patients with~     complex thoracoabdominal aortic lesions who are suitable for endovascular (within the~     vessel) repair with a physician-modified Medtronic Thoracic Valiant stent graft. The~     Medtronic Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular~     end prosthesis which is modified/customized by the Investigators to fit the patient's~     anatomy. The device is constructed by making a taper in the larger proximal thoracic device~     and attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral~     vessels are sutured to holes made in the tapered section. The modified Valiant stent graft~     is advanced to the lesion site endoluminally via the iliac/femoral artery. Access for~     delivery of extensions to the device will be delivered through the left subclavian artery.~     Upon deployment, the stent graft self-expands at the target location, where it is designed~     to exclude the lesion by restoring blood flow through the stent graft lumen.~   "
40657|NCT02524821|"~     The purpose of this study is to determine the effect of Gelesis100 on the absorption of~     metformin both with and without a meal.~   "
40658|NCT02524808|"~     This is an observational prospective study. Patients diagnosed with advanced epithelial~     ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by~     signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to~     select the best regions for tissue sampling to perform the following molecular studies:~     array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected~     mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on~     the samples.~   "
40660|NCT02524782|"~     A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to~     evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of~     MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).~   "
40661|NCT02524769|"~     The medical field is beginning to adopt treatments that alter an individual's microbiome to~     improve patient health; however, this approach has not been adopted for treatment of lower~     urinary tract symptoms (LUTS). Here, the investigators propose the first step in development~     of such a therapy. If the investigators hypothesis is correct, the investigators could~     change the first line of treatment for hypoestrogenic women and develop future therapies~     that modulate bacteria in the bladder to improve not only LUTS but also treatment response.~     This could lead to the first treatment for lower urinary disorders that incorporates a~     person's individual microbiome.~   "
40662|NCT02524756|"~     The aim of this study is to assess:~        1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type~          III/C1 as regard surgical technique, blood loss and operative time.~        2. Evaluate patients' outcome as regard bladder function and quality of life.~      in order to preserve the function of the bladder and the rectum, it is necessary to modify~     the traditional procedures, so as to identify the precise anatomical information directing~     the technique for optimal preservation of bladder function at the time of radical~     hysterectomy.~      The laparoscopic technique offers several well-known advantages. Under the magnified view of~     the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and~     precise dissection of the para-cervical structures and areolar tissue, including the blood~     vessels and the nerves.~      Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior~     hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good~     knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as~     this qualification could prohibit long-term bladder and voiding dysfunction during~     nerve-sparing radical hysterectomy~   "
40663|NCT02524743|"~     The purpose of this study is to determine whether efficacy of different doses of lidocain~     and acetaminophen for the prevention of rocuronium injection pain and frequency of~     withdrawal movements during the general anesthesia induction period.~   "
40664|NCT02524730|"~     The purpose of this study is to collect basic function, radiographic and patient~     satisfaction data for observation and analysis.~   "
40665|NCT02524717|"~     The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in~     participants with mild and moderate hepatic impairment.~   "
40666|NCT02524704|"~     The goal of this feasibility study is to evaluate the ability of Electrical Impedance~     Tomography (EIT) for providing regional and quantitative information about the extent and~     nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted~     to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography~     low amplitude, low frequency current is applied on electrodes, and the resulting voltage is~     measured and used to computed the electrical properties of the interior of the chest as they~     change in time. The computed properties are used to form an image, which can then be used~     for monitoring and diagnosis.~   "
40667|NCT02524691|"~     The study is designed to establish the level of agreement between the ROM Plus test and the~     diagnosis of ROM as defined by the patient's clinical course, with respect to a population~     of pregnant women who present to the clinical site with signs and symptoms suggestive of~     ROM.~   "
40668|NCT02524678|"~     The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in~     healthy subjects.~   "
40669|NCT02524665|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever~     the reason, poor compliance translates to decreased efficacy and increased frustration on~     the part of the user.~      The current study will evaluate and compare the efficacy and tolerability of 2 over the~     counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5%~     benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam~     compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne~     Treatment Gel (1% SA) and Skin Perfecting Lotion.~   "
40670|NCT02524652|"~     Early rehabilitation after anterior cruciate ligament reconstruction is of paramount~     importance and requires optimal pain control based on a multimodal concept, including~     injection of local anaesthetics. Regarding this latter, different options have emerged~     recently such as the adductor canal block, performed before the surgery by the~     anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of~     the intervention. No trial has compared these two approaches. As practice of medicine should~     be based on evidence, we decided to undertake this randomised controlled trial where we~     compared the adductor canal block with the local infiltration analgesia technique in terms~     of pain and functional outcomes~   "
40671|NCT02524639|"~     The purpose of this pilot study is to generate data to assess feasibility of study~     design/procedures and for formal sample size estimation for a larger multicenter study of~     the efficacy and safety of sirolimus in infants with medically-unresponsive congenital~     hyperinsulinism (HI) due to inactivating mutations of adenosine triphosphate-sensitive~     potassium (KATP) channels.~   "
40672|NCT02524626|"~     Hypothesis:~      Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead~     to a faster postoperative recovery after abdominal surgery.~      Aims:~      In the present study, the investigators want evaluate the anti-inflammatory effect of~     peroperative electrical stimulation of the vagus nerve. In addition, the investigators want~     to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To~     this end, the following aims are formulated:~        1. to determine whether vagus nerve stimulation leads to an improvement in~          gastrointestinal transit using radiological testing~        2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical~          improvement (daily questionnaire)~        3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the~          inflammatory response to abdominal surgery~   "
40673|NCT02524613|"~     Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic~     diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed~     annually in the U.S. Most of them are performed by practicing hematologists/oncologists in~     their offices or hospitals. However, a significant number are performed by~     hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of~     complications associated with bone marrow biopsy are largely unknown. This study has two~     goals:~        1. The first goal is to objectively determine by CT and clinical assessment, the actual~          risk to patients of the bone marrow biopsy and the rate of pelvic injury in an~          unselected group of hematology patients requiring a bone marrow biopsy, as performed by~          hematologist-in-training.~        2. The second goal is to determine the quality of bone marrow biopsies obtained, using the~          lateral angulation technique.~   "
40674|NCT02524600|"~     Cardiological examination is one of the major directions in nuclear medicine for detection~     of myocardial ischemia in patients with suspected coronary artery disease. In Caen, they~     constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile~     innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4~     minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical~     solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To~     date, apart from the work on heart ghosts and one publication in abstract form in 2009, no~     other study have been published.~      The goal of the study is to study the technical performance of the innovative technology~     IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .~   "
40675|NCT02524587|"~     The total hip replacement, with over 120,000 cases per year in France, provides short term,~     excellent functional results and a significant improvement in quality of life, in almost all~     cases. However, the observation has shown that the lifetime of the implants is limited due~     to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic~     osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions~     have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on~     the two components of the couple) or improving quality polyethylene. Improving the~     resistance of polyethylene wear is the primary objective evaluated in this study.~   "
40676|NCT02524574|"~     In patients with heart failure, the drive to the effort has demonstrated its safety and its~     interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is~     impaired by decreased activity of endothelial NO synthase. The rehabilitation training~     significantly improves peripheral endothelial function, and this improvement is correlated~     to the increase in exercise capacity. The impact on coronary endothelial function remains~     poorly documented, especially in non-ischemic dilated heart disease.~      The main objective of this study is to investigate the effectiveness of cardiac~     rehabilitation on the restoration of coronary endothelial function in cardiac failure~     patient evaluated with Tomography Positron Emission 15O-H2O.~   "
40677|NCT02524561|"~     Combined estrogen and progestin therapy has been shown to increase mammographic density and~     incidence of breast cancer in randomized trials. We propose to examine the effects of now~     commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of~     abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early~     Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal~     of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic~     micronized progesterone on progression of subclinical atherosclerosis in recently menopausal~     women. Prior studies of low-dose HT have been of short duration and small size. By~     determining the effects of low-dose hormone therapy on the breast, the proposed ancillary~     study will add important information about the estimated balance of risks and benefits~     associated with low-dose HT and will help guide future research trials.~   "
40678|NCT02524548|"~     The purpose of this study is to determine whether weekly SMS reminders are effective in~     improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.~   "
40679|NCT02524535|"~     Regardless of age, the quality of hospital care, the confidence that the young can have in~     the health care team, joining parents are pivotal elements and influence followed. Family~     support is all the more important as 14% of young people realize a new suicidal act within~     three months of hospitalization for attempted suicide, and that the essential predictors~     appear to be the young age and quality of intra-family relationships.~      The main objective of this study is to determine, through the construction of an instrument~     to quantify the therapeutic alliance, defined by the characteristics of the mobilization of~     the entourage and the mutual commitments in the care of nursing teams and the entourage, the~     role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether~     primosuicidants or repeat offenders, on short and medium term recurrences and early~     mortality.~   "
40680|NCT02524522|"~     This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation~     from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the~     mechanical ventilation and the number of pulmonary complications in the early postoperative~     period after cardiac surgery.~   "
40681|NCT02524509|"~     The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured~     Chondrocyte) by comparing between Chondron implantation and Microfracture.~   "
40682|NCT02524496|"~     Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the~     compassionate use of cisapride to treat patients who had no other effective therapy. For~     this observational study, 3 patients who had already been prescribed cisapride by outside~     physicians, were followed to determine the effectiveness of cisapride on their gastric~     emtpying.~   "
40683|NCT02524483|"~     Background: Outcomes from the investigators' recent exploratory investigation suggested that~     a high dosage of challenging physical therapy exercises can result in clinically relevant~     improvements in the postural balance and walking speed of individuals with MS.~      Objective: The investigators anticipated that the promising results were due to the novel~     challenging postural balance and mobility exercises. The purpose of this investigation was~     to test this notion by evaluating the mobility and postural balance improvements that could~     be achieved in a cohort of individuals with MS who participated in a therapeutic protocol~     that consisted of activity based exercises, and a cohort of individuals with MS that~     participated in the challenging physical therapy protocol.~   "
40684|NCT02524470|"~     To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the~     in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and~     console. The VSP System will be incorporated into the study site's Information Technology~     infrastructure.~   "
40685|NCT02524457|"~     The purpose of the study is to describe the molecular mechanisms related to an increased~     visceral fat mass and changed T-cell homeostasis. the project is expected to add new~     knowledge to the field of metabolic diseases after menopause and increase the focus of how~     lipid affects the development of metabolic disease in relation to the menopausal transition.~   "
40686|NCT02524444|"~     Randomized controlled single blind prospective comparative study.~   "
40688|NCT02524418|"~     This is a prospective evaluation of the clinical utility of the new cholangioscopy platform~     SpyGlass DS. The aims of this study are to prospectively document the clinical utility and~     technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and~     management of pancreata-biliary disorders.~   "
40689|NCT02524405|"~     The main objectives for this study are:~        1. To investigate three novel, non-invasive ocular measurements in a cross-sectional study~          of participants with various neurodegenerative dementias against standard cognitive~          assessments and brain imaging measures; and~        2. To assess the potential utility of ocular assessments for early detection in the~          pre-dementia, i.e. the so-called Mild Cognitive Impairment (MCI) stage.~   "
40690|NCT02524392|"~     A randomized controlled trial comparing independent medical evaluation (IME) to treatment as~     usual (TAU). Participants will be individuals reaching six months uninterrupted sickness~     absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).~   "
40691|NCT02524379|"~     The purpose of this study is to determine the safety of using intravenous Glyburide~     (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI).~   "
40692|NCT02524366|"~     We propose a randomized non-blinded comparison of standard vs. transcorporal approach for~     placement of an artificial urinary sphincter in male patients with stress urinary~     incontinence after radiation and radical prostatectomy for prostate cancer. In the United~     States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is~     the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff,~     which is the portion of the device that encircles and occludes the urethra, is typically~     placed directly around the urethra (i.e., standard placement). The cuff can erode into the~     urethra. Transcorporal placement has been introduced as a method to reduce the risk of~     erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so~     as to protect the dorsal aspect of the urethra. This approach has never been compared to~     standard placement in a randomized fashion. In our randomized trial, no additional~     procedures beyond the normal care protocol will be required of the patients. We will conduct~     the study through our established, IRB-approved multi-institutional network of surgeons.~     Success will be assessed via objective and subjective methods; complications will be tallied~     in a standardized fashion. Outcomes will be measured at two years.~   "
40693|NCT02524353|"~     Countless studies are performed to quantify the severity of heart disease and its influence~     on the respiratory system, checking that their heart conditions and the surgical process~     determine pulmonary complications, one of the most common causes of morbidity and mortality~     in the postoperative period of cardiac surgery . After surgical procedures, there is a~     reduction of the residual volume (RV), total lung capacity (TLC), vital capacity (VC) and~     functional residual capacity (FRC), leading to the formation of atelectasis, with~     alterations in the ventilation-perfusion ( V / Q), the partial pressure of carbon dioxide in~     arterial blood (PaCO2) and partial pressure of oxygen in arterial blood (PaO 2).~      Pulmonary function is impaired in the postoperative period of cardiac surgery, due to~     various factors common to this major surgery that will drive the patient to develop~     respiratory complications such as atelectasis and pneumonia. Physical therapy plays an~     important role in the treatment of patients undergoing cardiac surgery, both in the~     preoperative period and postoperative, in order to prevent or minimize the respiratory~     complications.~      Follow-up studies on cardiac rehabilitation quantify the quality of all the activities~     necessary to ensure to patients with heart disease patients the best physical , mental and~     social conditions so that consequently they are able , with its effort to regain a normal~     position in the community and lead a active and productive life over time, therefore, the~     clinical changes resulting from an extensive cardiac surgery are already highly dedicated~     described in literature but which daily life factors or rehabilitation interventions that~     the patient will take in the late postoperative period that really assisted in his complete~     recovery and inclusion into society they are still not well elucidated , so it is~     appropriate to carry out this project due to the fact exposed to up.~      The project to be developed whose main justification clarify issues related to the return or~     preservation of the individual feature that undergoes extensive cardiac procedure , as well~     as incidence of mortality after 12 months of the procedure. The current literature does not~     expressed clearly, possible impacts on functionality and return the daily activities of the~     individual in the late postoperative period , since such malfunctions in the immediate post~     operative period are already fully understood.~   "
40694|NCT02524340|"~     The best treatment plan for Juvenile Idiopathic Arthritis (JIA) is often complicated.~     Patients and clinicians often don't know what is the best treatment strategy for a given~     patient at a given time. The purpose of this study is to develop a method to analyze data in~     situations where the treatment and disease state change over time. The researchers will~     develop a web-based package that will use the methods developed in this study. The package~     will be easy to use and allow dissemination of the methods to the public.~   "
40695|NCT02524327|"~     The first aim of this study is to compare two methods of administration of intravenous~     anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual~     or automated and to determine a mid-term (6 months) influence of the frail phenotype on~     self-sufficient elderly patients after general anesthesia.~   "
40696|NCT02524314|"~     The purpose of this study is to collect safety and performance data on the use of the~     Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and~     alignment for the treatment of acute humerus fractures.~   "
40697|NCT02524301|"~     The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear.~     Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia~     nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a~     ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the~     interaction between endogenous opioids and their receptors.~   "
40698|NCT02524288|"~     The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG)~     + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the~     number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also~     assess the safety and tolerability of the ENG-E2 vaginal ring.~   "
40699|NCT02524275|"~     This phase II trial studies the side effects and how well docetaxel and capecitabine work in~     treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that~     has come back or spread to others places in the body. Drugs used in chemotherapy, such as~     docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
40709|NCT02524145|"~     The purpose of this study is to determine the mechanisms of chronotropic incompetence~     (inability to increase heart rate with exercise) in patients with heart failure and~     preserved ejection fraction (HFpEF). The investigators will test both central command~     regulation and cardiac beta-receptor sensitivity over control of heart rate.~   "
45749|NCT02458183|"~     The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV~     combination vaccine compared with those of separate DTaP and IPV vaccines administered to~     healthy infants at 2, 4, and 6 months of age.~   "
40700|NCT02524262|"~     Atrophic gastritis with hypochlorhydric milieu is a risk factor for gastric cancer. Microbes~     colonizing the acid-free stomach oxidize ethanol into acetaldehyde, a group 1 carcinogen.~     The aim is to assess gastric production of acetaldehyde and its inert condensation product,~     non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment~     with slow-release L-cysteine or placebo.~      Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17~     are studied. On separate days, patients will be randomly assigned to receive 200 mg~     slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg)~     ethanol. After intake, gastric concentrations of acetaldehyde, ethanol, L-cysteine and MTCA~     are analysed for 4 hours.~      Expected results show mitigated exposure of the gastric mucosa to acetaldehyde.~   "
40701|NCT02524249|"~     Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth~     weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such~     as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in~     very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective~     studies and recently published retrospective studies demonstrated that early caffeine given~     within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns.~     Retrospective design can be biased as newborns with mild lung disease may have received~     caffeine early for extubation. There are several studies on pharmacodynamics and~     pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine~     levels and BPD outcome is deficient.~      Primary objective of this study is to test the hypothesis that early caffeine given within~     24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns.~      This study will also test an additional hypothesis that higher caffeine dosage and caffeine~     levels are associated with decreased mortality and postnatal morbidities in studied~     newborns.~   "
40702|NCT02524236|"~     The primary objective of this study is to compare the efficacy and safety of a single~     injection of 50 U and 100 U doses of BoNT-A for the treatment of BPH-associated LUTS.~   "
40703|NCT02524223|"~     Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted~     diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk~     of oncogenicity especially for the anal and cervical mucosa. At the present time, no~     recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP)~     procedures. The main objective of this prospective multicentric cohort study is to evaluate~     the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives~     are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP,~     (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the~     correlation between HPV and male infertility and (4) the correlation between HPV and success~     rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV~     vaccination policy.~   "
40704|NCT02524210|"~     Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic~     prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as~     anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases~     the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these~     circumstances the risk / benefit of dabigatran could be improved by combining it with~     gastric protectors such as inhibitor drugs proton pump (IPP).~      Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of~     co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy~     subjects.~   "
40705|NCT02524197|"~     To assess the safety and tolerability of orally-administered CR845 in patients with~     osteoarthritis (OA) of the hip or knee. The study drug is being tested to reduce OA pain,~     and will be taken twice a day for two weeks, with four different doses (strengths) being~     tested. From screening period to follow up examination, the study is expected to last for up~     to 38 days per participant.~   "
40706|NCT02524184|"~     Obesity and metabolic disease result when energy intake consistently exceeds energy~     expenditure. One appealing new target for treatment is the activation of brown adipose~     tissue (BAT), an organ recently found to be functional in adult humans. Brown adipocytes~     selectively express uncoupling protein 1 (UCP1), which renders the inner membrane of~     mitochondria leaky, thereby diverting chemical energy from ATP generation to heat~     production. Interest in BAT has been spurred by the recognition that in addition to~     classical BAT depots, other brown-fat-like cells are present in the subcutaneous white~     adipose tissue (WAT) in animals and also in humans.These cells have structural and~     functional properties that resemble brown adipocytes, and they are referred to as beige or~     'brite' (brown-in-white) adipocytes. Interestingly, browning of WAT can be induced in~     animals and humans by physiological stimuli such as cold exposure, which increases~     adrenergic tone, and by exercise, which selectively drives WAT browning through irisin, an~     exercise-induced myokine. In addition b-adrenergic drugs and other pharmacological~     agents,such as prostaglandins, can induce browning of white adipose tissue. More recently,~     one study showed that treatment of C57BL/6 mice with phosphodiesterase inhibitor sildenafil~     (12 mg/kg/d) for 7 d caused 4.6-fold increase in uncoupling protein-1 expression and~     promoted establishment of a brown fat cell-like phenotype (browning) of WAT in vivo.~     Therefore, the investigators hypothesized that sildenafil can promote browning of white~     adipose tissue and improves insulin sensitivity in human adults.~   "
40707|NCT02524171|"~     The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is~     effective for reducing risk of criminal recidivism and improving other health-related~     outcomes (substance use, mental health, housing, and employment problems) among~     justice-involved Veterans entering residential mental health treatment programs in the~     Department of Veterans Affairs (VA).~   "
40708|NCT02524158|"~     Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current~     treatment options have limited effectiveness. In addition to chronic pain, people with~     chronic low back pain experience increased disability, psychological symptoms such as~     depression, and reduced health-related quality of life. This randomized controlled study~     will examine the impact of yoga therapy for improving function and decreasing pain in VA~     patients with chronic low back pain. Although not every VA patient with chronic low back~     pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly~     appealing to many VA patients. If yoga is effective, it could become an additional low-cost~     option that the VA can offer to better serve Veterans with chronic low back pain.~   "
40710|NCT02524132|"~     In this research project, the investigators addressed if incorporating physical movements~     with preschoolers will help increase their ability to retain concepts learned in preschool~     such as letter, sound and number recognition. Movement plays an important role in the brain.~     Exercise shows many benefits for the brain to help maintain clearer thought, improve memory,~     and increase activity in the brain, especially the areas involved in memory, attention, and~     language. The following research includes an eight week study of the implementation of~     movement breaks with one preschool class, while using another class as a control group.~     During the two weeks of baseline data, data was collected from every student in both groups~     on their letter recognition with both upper and lower case, letter sound identification, and~     number recognition for numbers 0-10. The group that implemented movement breaks had~     three-five minute scheduled times to stop for movement. Data was collected and compared~     between the two groups to find differences in their academic performance.~   "
40711|NCT02524119|"~     The purpose of this study is determine whether the combination therapy with LEE011 and~     chemoembolization in patients with locally advanced Hepatocellular Carcinoma not amenable to~     curative therapies will provide greater efficacy than chemoembolization alone with a~     tolerable safety profile.~   "
40712|NCT02524106|"~     B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study,~     designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2~     weeks to bococizumab placebo subcutaneously every 2 weeks for LDL-C lowering in HIV-infected~     subjects.~   "
40713|NCT02524093|"~     Depression and anxiety are common in MS and often go untreated. Even symptoms which do not~     meet the threshold for a psychiatric diagnosis can have a significant impact on quality of~     life. Positive Mental Training (PosMT) is a 12 week programme which aims to help people~     overcome the negative thinking and feelings that come with worry and low mood and become~     more positive, confident and resilient. To find out if Positive Mental Training is helpful~     in MS the investigators are running a randomised controlled trial. The initial study is a~     pilot tiral, the primary function being examination of the feasibility and acceptability of~     this treatment in MS. Though sample size is small and consequently it may not be powered to~     detect a significant change in symptoms in association with the treatment, this will also be~     examined.~   "
40714|NCT02524080|"~     If patients get to optimal level of healthcare directly it will prevent suffering for both~     patients and their relatives and moreover save a lot of resources. In the project Care at~     the right care level (CRC) the Emergency Medical Services (EMS) will triage patients who~     are in need of primary health care to the Primary Care (PC) instead of to the Emergency~     Department (ED). This intervention should be implemented with the same medical safety as~     with traditional care in the ED and the patient and their relatives should experience~     corresponding confidence to the healthcare provider. To prepare this intervention this~     patient group and their care needs have to be identified by a retrospective journal review~     and a guideline has to be developed. To evaluate the patients' and their relatives'~     experience of the intervention, finally interviews will be implemented. This project is~     expected to provide answers whether it is possible to triage non-urgent patients to another~     care level with the same medical safety and that the patients experience the same confidence~     in healthcare. And further it will answer the question, if the care providers around the~     patient manage to collaborate.~   "
40715|NCT02524067|"~     This study examines the effect of an intervention consisting of dynamic circadian light and~     sound therapy, as well as systematic information on sleep pattern, agitated behavior and~     functioning level.~   "
40716|NCT02524054|"~     The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that~     has the potential to significantly improve symptom management and enhance the quality of~     care for patients with intractable dyspnea.~   "
40717|NCT02524041|"~     Based on the evidence that periostin is specifically involved in intra-cortical remodeling~     control, our working hypothesis is that assessment of its concentration in the serum would~     be helpful in identifying patients with severe cortical porosity, a critical parameter in~     bone fragility. Periostin expression by osteoblasts and osteocytes is part of the bone~     cortical response to anabolic stimuli such as mechanical strain or intermittent increase in~     parathyroid hormone. However, it remains unknown whether this expression may participate as~     well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent~     bone loss.~      In rare clinical situations in which trans-iliac bone biopsies will be necessary to better~     understand their bone status in addition to densitometry and biological bone markers~     assessment, specific analyses using immune-staining techniques will be performed on the bone~     sample. Data from routine follow-up every six months will be also collected in this specific~     sub-group.~      High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the~     opportunity of performing a virtual bone biopsy providing information on trabecular and~     cortical microarchitecture in vivo. These microarchitectural parameters allow a more~     accurate evaluation of the alteration of the bone structure and therefore of the fracture~     risk as compared to current tools used in clinical practice such as densitometry. However,~     the availability of such HRpQCT facilities is limited and there is on-going development on~     the best way of measuring porosity for example. The definition of a biological profile~     including key proteins such as periostin and sclerostin involved in porosity mechanisms is~     therefore of great interest. A better understanding of the relationship between bone matrix~     components and parathyroid hormone effects also appears as critical. Follow-up of routine~     evaluation parameters reflecting bone status in a subgroup of specific patients could also~     provide new and additional information.~   "
40718|NCT02524028|"~     The fMRI study is a prospective study with the objective of evaluating the effects of the~     autonomic central nervous system on the regulation of heart rate in patients with atrial~     fibrillation (AF). This study will compare a functional MRI (fMRI) scan in patients prior to~     a direct current cardioversion (DCCV) to a second fMRI scan taken post DCCV. In addition,~     this study will compare functional MRI (fMRIs) to a control group of heart healthy,~     age-matched patients who will also receive two fMRI scans spaced about one week apart.~      Our expectation is that at the end of this study, the investigators will have greater~     insight into the role of the central nervous system and more specifically the autonomic~     nervous system in modulating AF. The investigators expect that understanding the interaction~     between the central nervous system and cardiac arrhythmias will lead to the development of~     novel therapies that preserve and restore normal sinus rhythm. This study will serve as a~     pilot study with the goal of obtaining additional grant funding and expanding the study once~     differences in volumes of activation are demonstrated.~   "
40719|NCT02524015|"~     The purpose of this study is to see if a specific physical therapy intervention speeds~     recovery from stroke-related pusher syndrome.~   "
40720|NCT02524002|"~     The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel~     during labor speeds labor and reduces the rate of cesarean delivery.~   "
40722|NCT02523976|"~     In this single-center, open-label, no control,prospective clinical trial, a total of 30~     Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) patients will be~     enrolled. Dasatinib 100 mg per day will be given orally along with combination chemotherapy~     starting day 8 of induction chemotherapy. Dasatinib will be given continuously (if it's~     tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation~     chemotherapy and maintenance therapy.Patients can receive allogeneic hematopoietic stem cell~     transplantation (HSCT) or autologous HSCT whenever possible during their first CR.~     Otherwise, they will finish the consolidation chemotherapy. The purpose of current study is~     to determine the clinical efficacy and tolerability of combination therapy of Dasatinib with~     multi-agent chemotherapy in newly-diagnosed Ph+ ALL.~   "
40723|NCT02523963|"~     The purpose of this study is to identify the effects of family work shop for children with~     developmental delays.~   "
40724|NCT02523950|"~     The purpose of this study is to evaluate the safety and efficacy of staged and combined~     phacoemulsification with intraocular lens implantation and Descemet membrane endothelial~     keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction.~     Surgical and postoperative complications, visual acuity and corneal endothelial cell density~     are evaluated.~   "
40725|NCT02523937|"~     The purpose of the study is to evaluate the performances of Soluble Fibrin assay for~     exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to~     determine the threshold value from the ROC curves, the possible interest in the positive~     diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on~     the SF results.~   "
40726|NCT02523924|"~     This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel~     low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following~     radical prostatectomy.~   "
40727|NCT02523911|"~     The purpose of this study is to investigate Suprep bowel preparation, with and without the~     anti-gas medication simethicone, in terms of efficacy and patient tolerability in the~     preparation of patients undergoing routine colonoscopy for colorectal cancer screening.~   "
40728|NCT02523898|"~     Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which~     affects 12-21% of the population.Several studies performed evaluate the possible benefit of~     metformin alone or in combination with clomiphene (CC)as first-line treatment for~     infertility in women with PCOS have reported conflicting results. These conflicting results~     may be due to the presence or absence of insulin resistance(IR).Metformin decreases IR~     .However there is not a single randomized clinical trial with metformin in IR PCOS patients.~     Therefore, the aim of current study is to compare CC with coadministration of metformin and~     with CC with coadministration of placebo in IR PCOS patients to induce ovulation.~   "
40729|NCT02523885|"~     To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient~     management at the early stage of community-acquired pneumonia (CAP) requiring hospital~     consultation. Non-interventional observational study.~   "
40730|NCT02523872|"~     The specific aim of this study is to gather data on fluid balance, intravenous medication~     administration, electrolyte balance, and diuretic and dialysis use in patients with acute~     respiratory failure who might benefit from a strategy designed to limit fluid~     administration.~   "
40731|NCT02523859|"~     This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia.~     Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil~     as opioid analgesics and a neuromuscular blocker.~      In total, 530 patients will be randomized. This group of 530 patients will be split randomly~     into 2 groups as follows:~      • 106 patients will be randomized to induction with propofol plus fentanyl or sufentanil or~     remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive~     propofol and remifentanil until weaning from the mechanical ventilation on the ICU or PACU~     within 24 hours after induction.~      Afterwards, sedation with propofol as study medication has to be ended. If necessary, the~     sedation is to be continued with the hospital's own supplies (propofol or other sedative).~      • 424 patients will be randomized to induction with remimazolam 6.0 mg/kg/hr together with~     fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance,~     the patients will receive remimazolam and remifentanil until weaning from the mechanical~     ventilation on the ICU or PACU within 24 hours after induction.~      The primary endpoint is successful sedation is defined as a Narcotrend index of 60 or less~     during at least 85% of the maintenance time and no rescue sedative medication administered.~     The maintenance starts at arrival at the operation theater and ends with the completion of~     the last skin suture.~   "
40732|NCT02523846|"~     The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique~     for postoperative analgesia. Investigators are comparing between patient re-education and~     the background morphine infusion among patients who fail to achieve satisfactory analgesia~     using IV-PCA Morphine after laparotomy.~   "
40733|NCT02523833|"~     Hypersensitivity pneumonitis (HP) is a syndrome with variable clinical presentation in which~     lung inflammation is caused by inhalation of specific organic antigens or low molecular~     weight particles in previously sensitized individuals. Systemic symptoms may or may not be~     present. Chronic HP represents the final stage of the disease, caused by prolonged exposure~     to a particular antigen, leading to pulmonary fibrosis. In chronic HP, pulmonary function~     tests (PFTs) commonly present a restrictive ventilatory pattern, with decreased diffusion of~     carbon monoxide (DLCO). Some patients can also have obstructive disorders with expiratory~     flow limitation, due to obstruction of the small airways typically caused by bronchiolar~     involvement in this pathology. However, PFTs are relatively insensitive for detecting small~     airway involvement when there is concomitant interstitial fibrosis. First, conventional PFTs~     may be normal in patients with small airway involvement, since they contribute to less than~     30% of the total airway resistance. In addition, damage to the small airways in HP is~     generally occurring parallel to areas of focal fibrosis - even when small airways are~     involved, these regions can be completely ignored, since they are excluded from ventilation.~     In summary, traditional PFTs are not sufficiently sensitive to detect diffuse small airway~     involvement in these diseases. In these cases, other functional tests, such as forced~     oscillation technique (FOT) and high resolution computer tomography (HRCT) scans of the~     chest with expired studies, could be used for this purpose.~      This will be a cross-sectional study, which will include the following evaluations in 28~     patients with HP recruited from our clinic:~      - Clinical variables: (A) demographic and anthropometric data; (B) Clinical data: Onset of~     symptoms and time of diagnosis~      C) Dyspnea score:~      D) Smoking: * Current or former smoker * Smoking history (number of cigarettes smoked per~     day and for how long);~        -  Spirometry with forced and slow maneuvers before and after bronchodilator (salbutamol);~        -  Plethysmography to measure lung volumes;~        -  Diffusion capacity of carbon monoxide (DLCO);~        -  High-resolution chest CT with expiratory scans;~        -  Six-minute walk test;~        -  Cardio-respiratory test using a maximal incremental treadmill.~        -  Forced oscillation technique (FOT).~   "
40736|NCT02523794|"~     The purpose of this study is to evaluate the efficacy of electro-kinetically modified water~     (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis~     associated pain, and to evaluate the effect of EMW consumption on analgesic use for~     endometriosis associated pain.~   "
40737|NCT02523781|"~     It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes,~     chronic hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these~     informations, is to help prevent those consequences. Information tools have been known to~     enhance retention of information given orally. The objective of this study is to assess the~     knowledge and satisfaction of women after an episode of preeclampsia after reading an~     explanatory pamphlet on preeclampsia. The investigators also want to change their perception~     on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term~     consequences and the ways to prevent them.~   "
40738|NCT02523768|"~     IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the~     presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by~     immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this~     condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years~     post-transplant.~      The primary immunosuppressive induction regimens currently used in kidney transplantation~     are the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG,~     polyclonal) and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in~     the surface of T lymphocytes). Due to their potent and prolonged immunosuppressive~     properties, the ATG may prevent or delay the recurrence on renal transplant.~      The aim of this study was to evaluate the influence of induction therapy (ATG versus~     Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first~     kidney transplant.~      This is a prospective, multicenter, randomized, open trial with a follow-up period of 5~     years old.~      Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit~     immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4~     post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of~     4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in~     the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day~     4 after the graft. The maintenance immunosuppressive therapy is left to the discretion of~     the center.~      The primary endpoint will be the clinical and histological recurrence of IgAN defined by the~     presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the~     graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg~     / day.~   "
40739|NCT02523755|"~     With an efficient epidural analgesia the physiological effects of pain are disabled during~     labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of~     paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after~     labor with and without epidural analgesia. With more efficient breathing, the occurence of~     atelectasis should be reduced; this effect will be investigated in these settings for the~     first time with the electrical impedance tomography, which is a completely non-invasive~     measure.~   "
40740|NCT02523742|"~     Recently, we have shown functional resonance imaging (fMRI) that variations in signal~     induced by a language task were significantly lower in a semantic region of the left~     hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the~     temporal gyri medium and angular) in schizophrenic patients compared with controls matched~     for age, sex, level of education and handedness.~      Investigators wish to test the hypothesis that functional modification of the hemispherical~     specialization is specific language and also specific for schizophrenia.~   "
40741|NCT02523729|"~     Human milk is the most optimal food to provide all infants' needs before eating solid food.~     However, underproduction of milk is a common and concerned problem for breastfeeding women.~     In this case, proper milk-making foods reveal their importance on lactation. In many~     European countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate~     the secretion of breast milk. This study estimates the effects of non-alcoholic malt product~     during first three months of lactation.~   "
40742|NCT02523716|"~     To determine if exposure of older volunteers, age 50-70y, who are healthy, but not~     physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve~     cardiopulmonary functional capacity.~   "
40743|NCT02523703|"~     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning~     most often in subjects aged 20-40 years. In France, thanks to recent studies reported during~     general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3~     / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower~     Normandy, the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per~     year.~      The primary objective of this pilot study is to assess the levels of glutamate and aspartate~     (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in~     40 patients experiencing an event demyelinating central nervous system.~   "
40744|NCT02523690|"~     ICU acquired muscle weakness is a significant problem in patients recovering from critical~     illness. This trial will evaluate the safety and efficacy of a drug in improving muscle~     weakness in critically ill patients.~   "
40745|NCT02523677|"~     The purpose of this study is to examine relationships among lifestyle behaviors (i.e.,~     physical activity, sleep), cognitive function (i.e., memory, processing speed, and executive~     function), and quality of life in breast cancer patients and survivors across time. The~     investigators will compare the strength of these relationships across age cohorts and time~     since treatment and diagnosis. Participants will complete a battery of questionnaires and a~     set of cognitive tests on an iPad app specifically tailored for this study. A subset of~     participants will also wear an accelerometer for seven days. Data will be collected at~     baseline and 6-month follow-up.~      This research is critical to identifying potentially important approaches to improving~     health outcomes and quality of life in breast cancer patients and survivors. Previous~     research provides evidence of the influence of lifestyle behaviors on cognition and quality~     of life in healthy aging populations. However, despite data indicating cancer's negative~     impact on lifestyle behaviors, cognition, and quality of life, very few studies have~     investigated interactions among these factors in cancer patients and survivors.~   "
40746|NCT02523664|"~     To investigate which neuronal correlates underlie cortisol-induced enhancement of memory~     retrieval in PTSD and BPD.~   "
40747|NCT02523651|"~     The purpose of this study is to evaluate the safety of clinical injection of allogeneic~     human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether~     injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal~     disease.~   "
40758|NCT02523508|"~     Previous studies have shown that peripheral muscles weakness or inhibition is related to~     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle~     weakness. The purpose of the study was to assess the effect of spinal mobilization on the~     maximal muscle strength of the hip flexors and motor function.~   "
40748|NCT02523638|"~     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic~     increase of red blood cells and frequently also of white blood cells. The thickening of~     the blood in relation with a modified function of the cells has several consequences like~     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the~     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis~     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,~     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an~     additional risk of bleedings. As the disease progresses the size of spleen and liver~     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a~     progression at a later time point to a leukemia (increased formation of white blood cells)~     can occur.~      The aim of this study is to assess the ease of AOP2014 self-administration using dedicated~     questionnaires.~        -  To assess safety and tolerability: adverse events (AEs), laboratory parameters,~          electrocardiogram (ECG) throughout study.~        -  To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white~          blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs.~          values at Visit P1).~        -  To assess the feasibility of AOP2014 self-administration: defined as the ability of the~          patients to use the pen as a self-administration tool (ease of handling, safety,~          tolerability and efficacy).~   "
40749|NCT02523625|"~     Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in~     the elderly and which can lead to blindness in 20-30% of untreated cases. The study group~     have previously shown that ultrasound is a viable non-invasive alternative to temporal~     artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound~     assessment (measuring a dark halo around the abnormal blood vessels) between sonographers~     in different centres, requiring a labour intensive and time consuming training programme.~     The study group propose to standardise the training programme, and use ultrasound and~     clinical evaluation to define changes occurring over time and with treatment in patients~     with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore~     the use of algorithms to automate or semi-automate image interpretation.~   "
40750|NCT02523612|"~     Routine screening mammography has increased the non-palpable suspicious lesion detection~     rate, requiring histopathological evaluation. The discovery of atypical lesions on the~     breast biopsy is associated with two interrelated risks:~        1. The risk of underestimating the severity of the lesion biopsied currently leads~          systematically to achieve a surgical resection for these patients while a breast cancer~          (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary~          surgeries will be performed in 75 to 90% of cases (no cancer).~        2. These breast lesions confer long-term increase in the subsequent risk of breast cancer~          (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical~          lesions are then followed using clinical and mammographic annual evaluation.~      The goal would be to get a model to assess the risk and no longer operate those patients at~     high risk of BC. Several groups have attempted to identify predictors of concurrent or~     secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are~     often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia,~     atypical lobular hyperplasia) and no prediction model has been validated in prospective~     multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model~     (Nomat) has been developed, common to all atypical lesions, which can predict the presence~     of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the~     patient, the disappearance of radiographic abnormalities (microcalcifications in general)~     after the biopsy and initial radiological lesion size. This model has good performance with~     an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of~     20%, negative predictive value was 90%, and this model would have prevented the surgery in~     51% of patients (low risk patients by model). It is essential to validate this model by~     forward-looking and in different centers to ensure its relevance.~      This is a multicenter prospective validation of the model on 300 patients operated for~     atypical lesions in 20 centers. All patients with atypical breast lesions have a routine~     surgery. The clinical data, imaging and histological data will be collected prospectively.~     The main objective of this study is to validate the model Nomat.~   "
40751|NCT02523599|"~     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral~     inguinal hernioplasty via open laparotomy (tension-free technique).~      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical~     rating scale (NRS) from 0 hour through 72 hours postoperatively.~      The expected maximum study duration for each patient will be up to 60 days, including a~     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post~     implantation period including treatment and follow-up.~   "
40752|NCT02523586|"~     The intent of this study is to determine the difference in pharyngeal oxygen concentration~     in patients who have a natural airway (not intubated) using commonly available oxygen~     delivery systems.~      The investigators will test the hypothesis that oxygen concentration during the period of~     inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at~     high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen~     concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a~     simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson~     Rees circuit.~      A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered~     clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%.~     With a significance criterion of 0.05, 10 subjects would provide more than 90% power to~     detect a mean difference of 10%.~   "
40753|NCT02523573|"~     Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in~     patients with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC)~     improves hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive~     care unit patients admitted for ARF requiring BAL.~   "
40754|NCT02523560|"~     Applying modern technology of data collecting, monitoring, transmitting and analyzing in~     order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation~     in heart failure patients.~   "
40755|NCT02523547|"~     Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.~   "
40756|NCT02523534|"~     This is an electrogram mapping study that tests the ability of a new signal processing~     technique called electrogram morphology recurrence mapping to locate drivers in participants~     with atrial fibrillation. This study will also test the hypothesis that there are~     non-invasive markers that can predict driver location. Electrogram mapping will be performed~     in participants undergoing ablation for persistent atrial fibrillation. These participants~     will have a cardiac MRI and 12-lead ECG prior to the ablation procedure.~   "
40757|NCT02523521|"~     The purpose of this study is to determine the effects of a physical activity program for~     children with Bronchopulmonary Dysplasia.~   "
40759|NCT02523495|"~     Through clinical observation and data statistics, conclude the clinical outcome of target~     therapy in metastasis colorectal cancer and explore some biomarkers that relate to target~     therapy.~   "
40760|NCT02523482|"~     The study objectives are: to validate the subsets of Screening Tool of Older People's~     Prescriptions (STOPP) and Screening Tool to Alert Right Treatment (START), or STOPP/START~     criteria, and Beers criteria applicable to HAD by comparing their performance when applied~     to clinical and HAD for the same patients, and, using clinical data, to compare the~     performance of the full STOPP/START and full Beers criteria with each other.~   "
40761|NCT02523469|"~     The purpose of the study is to define the safety and tolerability of this drug combination.~     The study will also define the response rate of patients with advanced and unresectable~     NSCLC.~   "
40762|NCT02523456|"~     Rationale: Early detection and timely interventions are important determinants of clinical~     outcome in people with acute illness. Adverse outcomes including unplanned transfer to~     intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological~     changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based~     on bedside vital sign observations may help early detection, improve outcome of patients and~     reduce healthcare cost.~      EWS which are effective in predicting deteriorating patients developed in high income~     countries have been shown to lose sensitivity and specificity when applied to a low income~     setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are~     positive, widespread adaptation of these scores can significantly contribute to improved~     patient outcome, better utilization of ICU services and cost effective healthcare provision.~      Objectives: To describe the demographic characteristics of cardiac arrest patients and the~     availability of physiological variables for calculation various EWSs in DGH, Moneragala To~     validate an early warning score suitable for patients at DGH, Moneragala To examine the~     effectiveness of the selected EWS at improving pre-defined patient outcomes~      Proposed methodology:~      Study I: All clinical variables and patient characteristics of past two years collected~     retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before~     cardio respiratory emergency and at admission to hospital will be extracted. The~     availability of variables required for the calculation of various EWSs will be noted.~      Study II: All consecutive inpatient admissions for three months to all units except~     intensive care unit at DGH, Moneragala will be included to the study, prospectively. Data~     will be collected from bed head tickets using pre-defined data sheets by nominated medical/~     nursing officers daily. Demographic details and physiological data will be recorded on~     admission to ward. Physiological data for seven EWS will be collected twice daily by these~     medical/nursing officers.~      Study III: Training will be given for the staff to identify patients getting worse using the~     newly validated EWS. The outcome of this will be measured with information obtained from~     Study II.~      Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine,~     University of Colombo (EC-15-034).~   "
40763|NCT02523443|"~     The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA)~     is a better method for managing pain after liver resection compared to patient-controlled~     analgesia (IV PCA). Currently, the standard pain control method for liver resection patients~     is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a~     day to day basis after liver resection.~   "
40764|NCT02523430|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA） for nasopharyngeal~     carcinoma.~   "
40765|NCT02523417|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA）for breast cancer.~   "
40766|NCT02523404|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA）for lung cancer.~   "
40767|NCT02523391|"~     The purpose of this study is to compare the pharmacokinetics of capsule and tablet~     formulations of TA-8995 in healthy male subjects aged 18 to 55 years.~   "
40768|NCT02523378|"~     The goal of this research study is to learn how easy participants think it is to complete a~     symptom questionnaire.~   "
40769|NCT02523365|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA） for cervical carcinoma.~   "
40770|NCT02523352|"~     Aim of this study is to better understand pathophysiology of the alteration of respiratory~     mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to~     test this hypothesis with a physiological, interventional study conducted on volunteers at~     the magnetic resonance (MR) suite at Massachusetts General Hospital.~   "
40771|NCT02523339|"~     The purpose of the study is to test if oxygen saturation in retinal vessels is correlated~     with clinical parameters, such as visual acuity, central retinal thickness and presence of~     neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The~     study will not entail change in treatment of the disease.~   "
40772|NCT02523326|"~     Objective The aim of this study was to test a protocol for the extraction of high quality~     genomic DNA from saliva samples obtained with mouthwash and taken from patients with~     periodontal disease.~      Materials and methods Saliva samples were taken from 60 patients, then stored at room~     temperature. DNA extraction was carried out at distinct post-sampling times (10, 20 and 30~     days). Evaluation of genomic DNA was performed with spectrophotometry, electrophoresis, and~     PCR genotyping and sequencing.~   "
40773|NCT02523313|"~     This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II~     trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab~     plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment~     for stage IV melanoma with no evidence of disease (NED).~   "
40774|NCT02523300|"~     To explore the potential prognostic effect of glucocorticoid on the postoperative~     aorta-related adverse events after aortic dissections patients underwent thoracic~     endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given~     within 2h after TEVAR.~   "
40775|NCT02523287|"~     The purpose of this protocol is to generate a set of data that will be analysed by~     integrated systems biology approach, for validation in subsequent clinical trials or in~     animal models.~      240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad~     on Day 0, 12 will receive a placebo on Day 0.~   "
40776|NCT02523274|"~     The purpose of this research study is to evaluate the effects of combining physical exercise~     with a resveratrol supplementation on the physical function of older adults.~   "
40788|NCT02523118|"~     The purpose of this observational study is to find the best measures to define how well a~     person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE),~     eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or~     colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected~     for microscopic analysis. Treatments are then decided based on how the tissue looks. We are~     aiming to compare different tissue components such as inflammatory cell types with clinical~     symptoms. We want to see if scores on standard questionnaires can give us an idea how well~     the person is doing.~   "
40777|NCT02523261|"~     Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high~     scientific level as the reference treatment of cerebral infarction associated with proximal~     cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first~     time a major decrease (-35%) of disability related to severe cerebral infarction and~     reduction in mortality. These studies only used thrombectomy devices called stent retriever~     for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN,~     ESCAPE 2014, 2015). This criterion recanalization is important because it largely~     determines the functional prognosis of patients with severe cerebral infarction (Khatri,~     2014).~      These results are exciting but we can do even better. Indeed, already new thrombectomy~     devices are available with a special interest for ADAPT (A Direct Aspiration First Pass~     Technic). This distal suction system, with a high level of endovascular navigability,~     provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with~     stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never~     been assessed in a randomized controlled trial.~      We have previously conducted a comparative observational study between two recanalization~     strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever.~     The interventional neuroradiologist could, in case of recanalization failure with the~     Solitaire system, used another thrombectomy material left to the operator's choice. 244~     consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France)~     admitted for a cerebral infarction associated with proximal occlusion were included. This is~     so far the largest series of patients with ADAPT system. The complete recanalization rate~     was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral~     presentation at the European Stroke Organization, April 2015). Our research aims to show~     that a first line strategy of recanalization by thrombectomy using a distal suction system~     (ADAPT) is superior that the use of a stent retriever.~   "
40778|NCT02523248|"~     The aim of this randomized control study is to evaluate the effect of tonsillectomy with or~     without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.~   "
40779|NCT02523235|"~     Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly~     for lower extremity post-operative pain control, specifically for total knee arthroplasty~     and foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic~     for postoperative analgesia may be placed at various locations along the target nerves.~     Investigations of single-injection peripheral nerve blocks suggest that the onset of the~     block might be faster with one location over the other; but, the success rates are~     equivalent. However, remaining unknown is whether there is an optimal location to place a~     perineural catheter as part of a continuous peripheral nerve block.~   "
40780|NCT02523222|"~     This will be a quasi-experimental study comparing blood glucose values 30 minutes after~     feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal~     hypoglycemia.~   "
40781|NCT02523209|"~     While the duration of renal transplant function has increased over the last decade kidney~     transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general~     population. Fracture risk remains increased despite the improvement of immunosuppressive~     therapies (IST) that allowed the reduction of steroid administration. Potential explanations~     for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that~     occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2)~     that kidney transplanted patients are older and older (14% of kidney transplanted patients~     were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3)~     IST, besides steroid, may have deleterious effects on bone and 4) that secondary~     hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus,~     the pathophysiology and epidemiology of bone fragility of kidney transplanted patient~     remains insufficiently characterized. Despite these data, and contrarily to what is done for~     patients candidates for cardiac transplantation, there is no general consensus for~     performing bone evaluation before kidney transplanted . Thus it's necessary to individualize~     the management of bone fragility and prevent fractures according to strategies that remain~     to be defined, provided that patients at risk are better detected.~   "
40782|NCT02523196|"~     This study plans to learn more about a new test to look at liver function, the~     HepQuant-Shunt (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as~     an alternative to Hepatic Venous Pressure Gradient testing in patients with liver disease.~   "
40783|NCT02523183|"~     Many families of children with medically refractory epilepsy are choosing to use medicinal~     cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability~     and efficacy of these products are not known. The primary objective of this study is to~     determine how the use of MCBD affects children with medically refractory epilepsy in an~     observational study. Measures of evaluation to be used will include: laboratory values,~     developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.~   "
40784|NCT02523170|"~     A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in~     patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided~     fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited~     sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by~     standard surveillance. This part of the study will recruit 60 patients.~   "
40785|NCT02523157|"~     The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial~     which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.~   "
40786|NCT02523144|"~     Sedation Techniques for children undergoing transthoracic echocardiography (TTE).~   "
40787|NCT02523131|"~     The main study objective is to determine whether day and night automated closed loop glucose~     control combined with pump suspend feature will improve glucose control and reduce the~     burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone.~      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel~     group design study, involving a three-month period of home study during which day and night~     glucose levels will be controlled either by a closed loop system combined with pump suspend~     feature (intervention group) or by sensor augmented insulin pump therapy (control group).~      It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21~     years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through~     paediatric and adult outpatient diabetes clinics in each of the investigation centres.~     Subjects who drop out within the first four weeks of the intervention may be replaced.~     Participants will all be on subcutaneous insulin pump therapy and will have proven~     competencies both in the use of the study insulin pump and the study CGM device.~      Subjects in the intervention group will receive appropriate training in the safe use of~     closed loop insulin delivery system and pump suspend feature. All subjects will have regular~     contact with the study team during the home study phase including 24/7 telephone support.~     The primary outcome is between group differences in the time spent in the target glucose~     range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12~     week free living phase. Secondary outcomes are HbA1 at the end of treatment period, the time~     spent with glucose levels above and below target, as recorded by CGM, and other CGM-based~     metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic~     episodes.~   "
40789|NCT02523105|"~     This study evaluates the use of brain activity monitoring for early identification of~     pharmaceutical treatment efficacy and development of depression deterioration events.~   "
40791|NCT02523079|"~     The aim of the study is to compare the implementation and effectiveness of group and~     self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by~     occupational health services (OHS) in a randomized and controlled design (RCT) among~     different types of shift workers.~   "
40792|NCT02523066|"~     Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.~   "
40793|NCT02523053|"~     The aim of this study is to confirmed the role of intraoperative controlled release~     5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with~     high risk of preoperative prediction of microvascular invasion.~   "
40794|NCT02523040|"~     This research study is studying a chemotherapy drug Lenalidomide as a possible treatment for~     one of three histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester~     disease (ECD), or histiocytic sarcoma (HS).~   "
40795|NCT02523027|"~     This study will investigate the effect of two oral nutritional supplements (ONS) along with~     dietary counseling vs dietary counseling alone on growth among picky eating children from~     India, aged > 24 months to ≤ 48 months over a period of 90 days.~   "
40796|NCT02523014|"~     This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor~     GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew~     back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
40797|NCT02523001|"~     The purpose of this study is to test the hypothesis that the function and/or regulation of~     urinary aquaporin 2 in hypercholesterolemic humans is affected by standard statin therapy,~     as compared with diet alone~   "
40798|NCT02522988|"~     The purpose of this randomized-controlled, crossover pilot trial is to evaluate the~     feasibility, acceptability and effects of a non-deceptive (open-label) administration of~     placebo pills for treating cancer related fatigue (CRF). If significant effects are found,~     the investigators will later determine if the presence of a COMT Val18Met genotype variant~     predicts placebo responses.~   "
40799|NCT02522975|"~     This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO®~     and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The~     targeted population is anaemia patients with chronic renal disease who are naive to epoetin~     treatment and not yet on haemodialysis.~   "
40800|NCT02522962|"~     This project comprises a two-arm randomized controlled trial (RCT) complemented by~     qualitative research on innovative group-based intervention for people with Multiple~     Sclerosis (MS) performed in the primary health care and organized in collaboration with the~     services provided by a hospital's outpatient clinic. The RCT will be conducted by Nordland~     Hospital Trust, Bodø (NLSH), in collaboration with UiT The Arctic University of Norway (UiT)~     and the Norwegian Centre for Integrated Care and Telemedicine, University Hospital North~     Norway (NST). The overall purpose of the RCT is to demonstrate whether high-intensity~     individualised group-based core stability training (GroupCoreSIT) performed by~     physiotherapists (PTs) in the primary health care has effect on balance, walking and~     activities of daily living (ADL) in people with MS compared to standard care. Changes in~     quality of life and costs will also be studied to conclude whether the intervention is~     cost-effective. The qualitative study contains three parts. The first part aims to~     investigate users' experiences from participating in the new group intervention and in~     standard care. The researchers will particularly focus on reflections regarding content,~     feasibility, potential changes in ADL, self-management, and continuity of care. The second~     part will investigate how the PTs act and interact with the group while conducting the~     intervention, particularly how individualization is carried out, and the PTs' reflections~     from participating in the education and performance of the intervention. The third part~     explores health professionals' reflections regarding coordination of care in people with MS.~   "
40801|NCT02522949|"~     This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation~     of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of~     participants will receive ColdZyme® mouth spray while the other half will receive placebo.~   "
40802|NCT02522936|"~     This is a randomized placebo controlled trial of the use of Biotene versus no treatment in~     women receiving oral oxybutynin for overactive bladder. The primary outcome will be rate of~     discontinuation of oxybutynin at 6 month.~   "
40803|NCT02522923|"~     This study is a randomized controlled trial conducted at two clinical sites. The purpose of~     this study is to determine whether patients with musculoskeletal injuries do better by~     seeing a primary care provider first versus seeing a physical therapist first. Target~     enrollment is 150 subjects.~   "
40804|NCT02522910|"~     This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3~     dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY~     1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with~     docetaxel in subjects with second- or third-line NSCLC.~   "
40805|NCT02522897|"~     The purpose of this study is to determine if additional panretinal photocoagulation of~     ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and~     allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment~     following the trea-and-extend scheme.~   "
40806|NCT02522884|"~     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate~     the safety and efficacy of the Tack Endovascular System in subjects with post-balloon~     angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and~     proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.~   "
40807|NCT02522871|"~     A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness~     of the OCS™ Liver to preserve and assess donor livers intended for transplantation.~   "
40808|NCT02522858|"~     Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on~     respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to~     prolong the anesthesia time when used with patients undergoing spinal anesthesia. However,~     dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose~     dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication~     of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.~   "
40809|NCT02522845|"~     This study will be looking at the effect of compression therapy in patients having~     endovenous treatment for truncal incompetence of their varicose veins using either~     radiofrequency ablation (RFA) or endovenous laser therapy (EVLT). Patients will be~     randomised to either the compression group (group A) or the no compression group (group B).~      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as~     the cost effectiveness of each intervention will be assessed.~   "
40810|NCT02522832|"~     A GMP rhinovirus was manufactured according to GMP and then characterised in human~     volunteers in the human viral challenge model.~   "
40811|NCT02522819|"~     This project is focused on the treatment of obstructive sleep apnea in the acute phase of~     stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it~     has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke,~     on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke~     have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is~     associated with worse functional outcomes and higher mortality in the post-stroke period.~     Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to~     aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially~     reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary~     treatment for obstructive sleep apnea.~      Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of~     CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one~     randomised trial has provided the means to document neurological improvement at mid term (1~     month) in a targeted population.~      Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of~     ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at~     the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate~     the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.~   "
40812|NCT02522806|"~     In spite of all progress realized in the field of assisted reproduction the pregnancy rate~     by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.~      Different causes may account for these failures and that, during all stages of pregnancy.~      Recent studies have investigated an essential step in fecundation : uterine receptivity.~     Some teams have shown that a lot of immunological factors would have very significant in~     this step, by them possible expression in this process. Other studies looked at genes~     modulation, essential to implantation, with endometrium manipulation, simple, such as~     endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF~     failures, are most encouraging because the pregnancy rate for these teams after just~     endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate.~     Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine~     receptivity and suggest with results, suitable treatment for each patient (ongoing study).~      EB is quick, easy, make in a simple consultation and with a low cost, contrary to~     immunological study, which depend of ultra-specialized laboratories and therefore with an~     important cost.~   "
40813|NCT02522793|"~     1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia,~          and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful,~          the optical measurements could be used to survey for and delineate the extent of~          malignancies in a noninvasive manner.~        2. Study activities and population group: Competent adults with a clinically suspicious~          skin lesion who are undergoing a biopsy as part of their routine care. For those who~          agree to participate, the sterilized portable optical spectroscopic probe will be used~          to measure diffuse reflectance on the lesion of clinical interest.~        3. Data analysis and risk/safety issues: The optical spectrometer does not breach any skin~          defense barrier. As this study involves noninvasive optical measurements of tissues, no~          significant safety concerns are anticipated. Qualitative analysis will be performed to~          describe whether there is correlation between spectroscopy measurements and pathologic~          diagnosis. A variety of correlative statistics will be explored to determine if there~          are relationships found that can justify a larger study~   "
40814|NCT02522780|"~     The purpose of this trial is to investigate the safety and efficacy of mesalamine 2 g~     extended release granules (sachet) once a day (QD) for maintenance of clinical and~     endoscopic remission in subjects with UC. The duration of treatment for each subject will be~     6 months.~   "
40815|NCT02522767|"~     The purpose of this trial is to investigate the safety and efficacy of mesalamine for the~     induction of clinical and endoscopic remission in subjects with active, mild to moderate UC.~     Subject will receive 4 g extended release granules (sachet) once daily.~   "
40816|NCT02522754|"~     A study to compare multiple dosage regimes of a protesomal intranasal vaccine.~   "
40817|NCT02522741|"~     The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic~     stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for~     mothers receiving preventive services. The study intervention is adapted from Skills~     Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that~     the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as~     improve maternal and child well-being by reducing the effects of maternal PTSD and~     depression on parenting.~      The investigators plan to recruit mothers with high levels of trauma-related symptoms from~     preventive service agencies, and invite them to participate in the study. This study is a~     single group design, and data will be collected pre-treatment, post-treatment, and 12-week~     follow-up.~   "
40818|NCT02522728|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a~     prospective randomized clinical trial.~   "
40819|NCT02522715|"~     This phase I/II trial studies the side effects and best dose of cabazitaxel when given~     together with enzalutamide in treating patients with prostate cancer that has spread to~     other places in the body (metastatic) and has not responded to treatment with hormones~     (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Androgen can cause the growth of prostate~     cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the~     use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work~     better in treating metastatic, hormone-resistant prostate cancer.~   "
40820|NCT02522702|"~     The aim of the study is to develop a computer program which is able to distinguish between~     adenomatous and non- adenomatous polyps on the basis of optical features of the polyps.~     Still images of polyps (< 10 mm of size) will be collected during routine colonoscopy~     procedures. All polyps will be resected endoscopically so that histopathological diagnoses~     (gold standard) can be notified.~      In the validation phase of the study a computer program will be established which aims to~     distinguish between adenomatous and non- adenomatous polyps on the basis of optical features~     derived from still images. The program will operated using the the random forest learning~     method. Afterwards, in the testing phase of the study, still images of 100 polyps (not used~     in the validation phase) will be presented to the computer program. The establishment of a~     well- functioning computer program is the primary aim of the study.~   "
40821|NCT02522689|"~     It is aimed to evaluate the treatment results, rates of success and complications, and~     injury given to the kidney by measuring preoperative and postoperative blood and Cystatin C~     levels in patients with kidney stones smaller than 2 cm who will undergo either ultra-mini~     percutaneous nephrolithotripsy (PCNL) or micro PCNL.~   "
40822|NCT02522676|"~     It is aimed to evaluate the treatment results, rates of success and complications, and~     injury given to the kidney by measuring preoperative and postoperative blood urea,~     creatinine, Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in~     patients with lower pole or renal pelvis stone(s) undergoing either one of the treatment~     modalities including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL,~     ultra-mini PCNL, micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock~     wave lithotripsy (ESWL).~   "
40823|NCT02522663|"~     Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in~     numbers. With better surgical techniques and equipment, also older patients can be operated~     on, resulting in an growth of the older population. AVR is characterized by high rates of~     hospital readmissions, resulting in suboptimal care planning and higher health care costs.~     Hence, it is important to develop strategies to reduce hospital readmissions following AVR.~     The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the~     reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of~     anxiety, less depressive symptoms and a better health related quality of life.~   "
40824|NCT02522650|"~     This cross-over study is designed to test the hypothesis that amiloride will reduce urinary~     protein excretion and protect the kidney from rapid progression in proteinuric kidney~     disease.~   "
40825|NCT02522637|"~     International guidelines for pulmonary rehabilitation (Spruit et al 2014) describe pathways~     dedicated to moderate COPD patients looking at the work setting, programs and frequency of~     training sessions in an outpatient program of rehabilitation. However, a new population of~     respiratory patients is growing: these are more serious and older patients, with several~     comorbidities and recurrent hospitalizations. In this population no guidelines are available~     to describe the optimum prescription in terms of frequency, intensity, type and timing~     (FITT) of rehabilitation. In this kind of patients, only few studies are available on the~     overtraining risk. The aims of the current study are:~        1. To detect and compare the response in terms of endurance of two endurance training~          programs with different time-frequencies (1 session / day versus 2 sessions / day)~          during 30 days of in-hospital admission to a pulmonary rehabilitation center~        2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and~          respiratory muscle strength, quality of life and psychological and functional impact of~          the disease.~   "
40826|NCT02522624|"~     The overall purpose of the study is to better understand how the investigators previously~     developed decision support (DS) tool can help people make decisions about health insurance~     plans available through the federal exchanges created by the Affordable Care Act (ACA). The~     investigators will evaluate the DS tool compared to the federal government website. The~     investigators will also evaluate the feasibility of disseminating this tool. There are two~     primary aims to be completed in this project: (1) examine the reach and effectiveness of the~     health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood~     of implementation of the DS tool.~   "
40827|NCT02522611|"~     Background:~      Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead~     to anxiety, depression, and reduced mobility and quality of life. Researchers believe a~     research drug called resiniferatoxin (RTX) may be able to help.~      Objective:~      To learn whether RTX is safe and can reduce cancer induced bone pain.~      Eligibility:~      People ages 18 and older with CIBP that is not relieved by standard treatments~      Design:~      Participants will have up to 6 outpatient visits over about 7 months. These will include:~      Medical history~      Physical exam~      Blood and urine tests.~      Thermal testing: a disk placed on the skin to test ability to sense temperature in and~     around the area of pain~      Chest x-ray~      EKG: stickers are placed on the chest to measure heart signals~      ECG: measures electrical activity of the heart~      Participants will have 1 inpatient visit lasting 2-4 days. This will include:~      Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray~     contrast.~      A needle is passed through the skin of the back to inject the RTX.~      Participants will keep a log of the pain medications they take after surgery.~      Participants will be called 1 week and 2, 3, and 4 months after the injection.~      Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after~     the injection.~   "
40828|NCT02522598|"~     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity~     inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play~     important roles in induction and transmission of pain signals. There have been many efforts~     to develop selective drugs to treat pain, but usually unsuccessful due to the lack of~     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is~     expected to be a dual-target drug, demonstrated having a potential synergism between GlyT2~     and 5HT2A to maximize an antinociceptive effect in the in vivo animal models. In Phase 1~     conducted among healthy subjects, safety and tolerability were confirmed. Phase 2 was~     designed as a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate~     the efficacy and safety of the analgesic drug VVZ-149 injection.~   "
40829|NCT02522585|"~     The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia~     grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and~     ki-67 immunohistochemical staining and to the expression of NK cell receptors.~   "
40830|NCT02522572|"~     The primary objective of this study is to conduct a proof of concept pilot study that will~     provide a preliminary evaluation of the safety of plerixafor alone or in combination with~     bortezomib on plasma cell mobilization, Human Leukocyte Antigen (HLA) antibody levels and~     toxicity profile in sensitized patients awaiting kidney transplantation.~      The secondary objective of this study is to conduct additional analyses of the study regimen~     on HLA antibody levels using multiple different assays and statistical analysis.~   "
40831|NCT02522559|"~     Herbs and spices offer one potential solution to the recent decline in children taking~     school lunch because they can increase the palatability of foods without adding salt and~     fat. However, there is currently limited evidence on how to successfully integrate herbs and~     spices into the school lunch menu. Developing evidence-based methods to teach school~     cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs~     and spices is a research priority. The investigators hypothesize that herbs and spices can~     be used to increase acceptance, intake, and participation in the school lunch program among~     6th - 12th grade students from Central Pennsylvania.~   "
40832|NCT02522546|"~     Pneumococci are bacteria which can cause serious and potentially life threatening illnesses~     like meningitis and blood poisoning.~      Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since~     2006.Carriage studies allow assessment of how the strains in the nose change over time, in~     that by clearing some strains away which other strains take up those niches in their place~     both in children and in their close/household contacts. This helps to inform the best use of~     the vaccines available and for future vaccine development and which strains would be useful~     to include.~   "
40833|NCT02522533|"~     Frailty has been associated with poor acute and long-term outcomes after major surgery. We~     recently determined that nearly 70% of patients undergoing major thoracic surgery are~     pre-frail or frail. We are interested in assessing whether a strength training intervention~     for frail or pre-frail patients has an impact on surgical decision making and on surgical~     outcomes.~   "
40834|NCT02522520|"~     Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women~     are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other~     cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis~     is 71 years. Improved treatment has increased the number of survivors with an expected~     5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time~     of diagnosis they often live with comorbidities and have limited leisure time physical~     activity.~      There is evidence that rehabilitation in the form of physical exercise for cancer patients~     after their initial treatment has a positive effect on a number of physical and~     psychological parameter such as health-related quality of life, physical capacity and~     physical function, fatigue, anxiety and depression. However, the most frequently studied~     diagnosis group is women with breast cancer. Until now only few studies have evaluated the~     effects of physical activity among colorectal cancer patients receiving chemotherapy~      The purpose of this study is: to examine the effect of two different training initiatives -~     12 weeks progressive, high-intensity training versus low intensity exercise intervention -~     on physical, emotional and social habitus, in sedentary patients with colorectal cancer~     during adjuvant chemotherapy.~      The hypothesis of the study are: 1. That both interventions will show a positive association~     between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen~     uptake) and improved physical function, reduced fatigue and anxiety in the included~     sedentary colorectal cancer patients undergoing adjuvant chemotherapy.~      Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have~     self-reported physical activity level below the national recommended levels (less than 150~     min/week of moderate leisure time physical activity, and exercises at least 20 minutes of~     strenuous physical activity twice a week).~      Benefits and risks of participating: Possible benefits of the interventions: to reduce~     treatment related symptoms and side-effects, increase vitality and well-being and promote~     lifestyle changes among sedentary colorectal cancer patients receiving adjuvant~     chemotherapy. At participation in the interventions minor sports injuries may occur.~   "
40835|NCT02522507|"~     Despite the strong business case of hiring people with disabilities, a significant~     proportion of youth with disabilities leave high school and neither work nor continue their~     education and are unprepared to meet the demands of a work environment. Although youth with~     disabilities have much to gain from employment readiness programs, they are often excluded~     from, or have limited access to school and community vocational programs. One encouraging~     approach to address gaps in vocational programming is through peer mentoring, which may~     facilitate a smoother transition to adulthood by offering support to enhance coping skills.~     Despite the increase in online communities, little is known about their impact on vocational~     mentoring for youth with physical disabilities and their parents. The purpose of this study~     is to develop, implement and assess the feasibility of an online peer mentor employment~     readiness intervention for youth with physical disabilities and their parents to improve~     their self-efficacy, career maturity and social support.~   "
40836|NCT02522494|"~     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the~     prevalence of diabetes at almost 20 percent in VA patients. Poorly controlled diabetes leads~     to a number of complications including cardiovascular disease, blindness, amputation, and~     end stage renal disease. Adherence to medication regimens (as well as lifestyle factors such~     as diet and exercise) is important to achieve diabetes care goals. Adherence to recommended~     care is related at least in part to effective communication in medical encounters. This~     project is designed to test a video intervention to improve patients' communication~     behaviors. Providers will also receive a pamphlet with specific recommendation to improve~     communication skills. The project will assess the impact of the training programs on~     communication and outcomes. The study is designed to help make patient care more~     patient-centered, which is one of the six aims for improvement in the IOM Report, Crossing~     the Quality Chasm and is a goal of VA transformation efforts.~   "
40837|NCT02522481|"~     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced~     dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial~     border delineation (LV EBD) at rest and who are scheduled for coronary angiography.~   "
40838|NCT02522468|"~     The purpose of this randomized trial is to determine the superiority of utilizing~     radioactive seed localization (RSL) over wire-guided localization (WL) for palpable or~     non-palpable malignant lesions in patients undergoing breast conservation surgery (BCS).~   "
40860|NCT02522182|"~     The purpose of the ALLEPRE trial is to compare the benefit offered by a structured,~     intensive and fully nurse-led intensive secondary prevention intervention programme with~     that offered by standard of care in a high-risk population of patients admitted to hospital~     because of an ACS.~   "
40861|NCT02522169|"~     This clinical trail intends to evaluate interventions based on the Infliximab trough levels~     for an individualized therapy adaption for pediatric IBD-patients undergoing~     anti-TNF-alpha-therapy. Main aim of the individualized strategy is to attain and maintain~     early disease control in order to keep as many patients as possible in disease remission,~     and to avoid primary and secondary therapy failure.~   "
40839|NCT02522455|"~     This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks~     gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants~     require less overall pressure from the ventilator than the usual conventional settings used,~     with the aim of providing data to construct a larger trial looking at the longer term~     outcome of these infants using this type of ventilation in the future.~      Many preterm infants at these gestations require assistance from a ventilator due to the~     immaturity of their lungs. The lungs of preterm infants are susceptible to damage,~     especially if high pressures are needed or prolonged periods of ventilation. There is~     concern that if the infant's breathing pattern does not synchronise with the ventilator,~     this causes additional distress, longer duration of ventilation needed and increased risk of~     complications. Over the past 20 years, a different type of ventilation, known as flow-cycle~     ventilation, has been trialed, with limited use in preterm infants. This allows the baby to~     determine the duration of breathing in and out and how many breaths they require per minute.~     This would help babies to synchronise better with the ventilator, and consequently require~     less pressure from the ventilator.~      This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born~     under 32 weeks gestation, with a stable respiratory effort, will be eligible for~     consideration for the study. The study will last no longer than 5 hours and involve the~     babies receiving different pressures from the ventilator in flow-cycle mode for 1-hour~     epochs. Blood gases after each epoch and continuous ventilator data will be downloaded to~     assess their tolerance on the different settings, before being returned to the usual~     conventional settings used on the unit. The babies will have continuous monitoring~     throughout as per standard neonatal intensive care.~   "
40840|NCT02522442|"~     The primary objective outcome is the proportion of participants compliant (at least four~     hours of use per night for all nights) in the Auto Bilevel group compared to the continuous~     positive airway pressure (CPAP) group after 90 days of treatment during the investigation.~     Proportion will be calculated using the cumulative number of hours on therapy divided by the~     total number of days of the investigation for each participant. The mean and standard~     deviation of these mean therapy hours will then be calculated for each arm of the~     investigation. Participants with compliance of at least four hours will be classified as~     compliant and those with less than four hours will be classified as non-compliant. The~     null hypothesis will be rejected if the mean of the primary objective outcome for all~     participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly~     greater than that for all participants in the CPAP therapy arm~   "
40841|NCT02522429|"~     Few neurological conditions are as scientifically mysterious and clinically, legally, and~     ethically challenging as disorders of consciousness. To date there exists no standard~     intervention for patients suffering from these devastating conditions. The present project~     is aimed at evaluating the potential of non-invasive Low Intensity Focused Ultrasound~     Pulsation (LIFUP) of thalamus (a key area for the consciousness network) as a~     neurorestorative stimulation for those patients. In this study, LIFUP will be performed~     during two sessions. The proposed experiment will involve behavioral and paramedical~     measurements just before and after each of the two LIFUP sessions in a small sample of~     patients (up to 15) in order to evaluate the feasibility of a full scale clinical trial.~     Outcome measures will be administered at discharge, 6 months and one year after injury.~   "
40842|NCT02522416|"~     Corneal topography allows the measure of the radii of curvature and of the thickness of the~     cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal~     irregularities such as a keratoconus, or too thin corneas which are a contra-indication for~     laser refractive surgery.~      Several types of corneal topographers are commercially available. Some as the Orbscan(r),~     operate by analyzing the image of the patterns of a Placido disk associated with a light~     slit, allowing the collection of thousands of points of the anterior and posterior surface~     of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary~     cameras which capture images of the whole anterior segment of the eye. The aim of this study~     is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the~     central corneal pachymetry measurements measured pre- and postoperatively.~   "
40843|NCT02522403|"~     The patients with distal radius fracture treated with immobilization (cast) and percutaneous~     pinning it will be to able to participate in this randomized trial. The investigators will~     be able to determine if the laser acupuncture is a good therapy for the rehabilitation in~     this type of patients. And if they are more comfortable to begin his rehabilitation exercise~     after the application of this therapy~   "
40844|NCT02522390|"~     The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to~     develop and evaluate the open access Nutrition Researcher Cohort for gathering personal~     health data from nutrition researchers, including analytical methods, standards and~     operation procedures, data infrastructure, ethical and privacy aspects, and governance.~      Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound~     intake and exposure, biomarkers for food, health and/or disease and health and/or disease~     related measurements to study the relation between nutrition, health and development of~     disease (on individual level).~      In addition, data will be used to develop applications that visualise personal health risks~     based for example on (validated) recommendations and applications that predict individual~     health risks.~      The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort~     will be composed of about 250 life sciences employees and students from different,~     predominantly European, countries. This allows optimal involvement of participants in~     shaping all aspects of the cohort and the ownership of data. We aim to recruit about in~     total 20 male and female scientists per participating country.~   "
40845|NCT02522377|"~     In this proof of concept study, the investigators plan to administer iv ketamine interleaved~     with ECT days.~      Patients with treatment resistant depression who are deemed to be eligible for ECT treatment~     will randomly be assigned to either ketamine or active placebo.~   "
40862|NCT02522156|"~     Almost one-fifth of US adults are current cigarette smokers. To make further progress in~     lowering prevalence, it would help to increase the proportion of smokers attempting to quit.~     This application tests a novel approach to motivating smokers to quit, based on an~     empirically supported theory of anxiety. The approach uses guided imagery to increase~     smokers' sense of urgency about preventing the negative health consequences of smoking.~   "
40863|NCT02522143|"~     Study Aims/Objectives:~      This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to~     the unique requirements of students meeting sub-clinical diagnostic criteria for BPD~     (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.~   "
40864|NCT02522130|"~     Different ways of reducing pain during IUD insertion have been explored. So a randomized~     study will be conducted to test their role~   "
40921|NCT02521376|"~     The primary objective of this study is to evaluate the pharmacokinetics of Entospletinib~     (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function~     (stratified by smoking status, as appropriate) relative to matched, healthy controls.~   "
40846|NCT02522364|"~     Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication~     after cardiac surgery requiring intervention or prolonged hospital stay.~      POAF is associated with higher mortality and higher risk of thromboembolic events.~      However, It is yet unknown whether a now event of postoperative atrial fibrillation is an~     indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial~     fibrillation or merely a response to the stress of surgery with not recurrence. This~     distinction is critical to determine the appropriate therapy. Since recurred events of~     atrial fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for~     stroke and thromboembolic evens patients with PAF are treated with long term~     anticoagulation. Missing the long term recurrence of arrhythmia may result in~     under-treatment and pose a significant risk of stroke.~      Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and~     stores electrocardiogram (ECG) recordings. It will enable the detection of atrial~     fibrillation over a period of years and allow correct diagnosis and appropriate treatment.~      The purpose of the study is to study the long term behavior of POAF, determine the~     likelihood of developing paroxysmal atrial fibrillation in patients with POAF and to define~     the risk factors for this eventuality~   "
40847|NCT02522351|"~     The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of~     swallowing in patients having dysphagia problems.~   "
40848|NCT02522338|"~     Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the~     kidneys, and its plasma assay reflects the GFR.~      Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on~     assay plasma cystatin C with that of the MDRD formulas.~   "
40849|NCT02522325|"~     This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for~     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which~     the subjective, physiological and reinforcing effects of cocaine are evaluated during~     maintenance on placebo and phendimetrazine.~   "
40850|NCT02522312|"~     A retrospective analysis of Restasis® benefits in dry eye contact lens patients.~   "
40851|NCT02522299|"~     The purpose of this study is to evaluate specific alterations in immune cell mechanisms~     related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger~     ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an~     exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment~     with GSK2269557 will also be measured using functional respiratory imaging (FRI) and~     spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study.~     The study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days~     1 to 84) and Follow phase (7 to 14 days after last dose). The total duration of the study is~     13-14 weeks including the screening visit.~   "
40852|NCT02522286|"~     This study implements a simple evidence-based patient activation intervention - Ask 3~     Questions- augmented by a novel theory-based intervention - Open Communication - aimed at~     activating patients and healthcare providers. The goal of this project is to increase~     patient and physician's preparedness for more having more questions, expressing differing~     opinions, and working collaboratively in making medical decisions that are both informed and~     responsive to patients' needs and preferences.~   "
40853|NCT02522273|"~     A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a~     baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is~     becoming distressed.~      In this situation a blood test can be taken from the scalp of the baby. A high lactate level~     in the blood indicates that urgent delivery is required to prevent long-term harm to the~     newborn.~      SensPoint is a new medical device that measures lactate. It has several potential benefits~     over the current method of measuring lactate in that it is a portable hand-held device~     (allowing for use in the delivery room), requires a much smaller volume of blood and~     produces results more quickly than the current method of measuring lactate.~      Before a new device is adopted into clinical practice, it is important that it is first~     confirmed that it is accurate and reliable for its intended use. This study will evaluate~     the ability of the SensPoint device to accurately and reliably detect lactate in fetal and~     umbilical cord blood by comparing its performance to the reference device currently in use.~   "
40854|NCT02522260|"~     This study on women with breast cancer during and after chemo- and hormonal therapy compares~     the effect of different physical training programs on physical and mental well-being and~     systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial~     biogenesis and function and other molecular processes in skeletal muscle biopsies are~     studied. The women will be randomly allocated into three different intervention arms, a~     control arm with usual care and two different training arms. All participants will respond~     to questionnaires and have blood samples and taken and for a subgroup muscle biopsies before~     and after the exercise intervention. Participants will be supported to uphold exercise~     through collaboration with Friskis & Svettis and followed for 5 years. Some of the women~     will also be asked to participate in an in depth interview about the experiences of exercise~     during ongoing treatment. This study will contribute to increased knowledge about the type,~     intensity and frequency of training that patients with breast cancer benefit most from with~     regards to impact on physical and mental wellbeing. This knowledge is of great importance~     since experience shows that patients and relatives often seek information about~     rehabilitation, self-care and physical activity. The study will also contribute to the~     improvement of the patients´ quality of life, ability to return to work, and reduce social~     costs, but above all, increase the possibility for development and implementation of~     evidence-based rehabilitation of women with breast cancer during and after active treatment.~   "
40855|NCT02522247|"~     To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.~   "
40856|NCT02522234|"~     This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627~     once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.~      The patients received the intravenous administration of the chemotherapy (docetaxol,~     doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1~     and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately~     24 hours after chemotherapy) each cycle for up to 6 cycles.~   "
40865|NCT02522117|"~     Renal insufficiency is a priority disease in the health system, which may require renal~     replacement therapy based on kidney transplantation, which is considered as therapy of~     choice. During the procedure of kidney transplantation, the body is subjected to~     ischemia-reperfusion damage that generates late complications related to graft function.~      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,~     which could be beneficial in kidney transplantation.~   "
40866|NCT02522104|"~     The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and~     renal failure requires a specific monitoring and dose adjustment in order to remain within~     the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For~     this reason the investigators propose to compare the pharmacokinetic parameters of~     hydroxyurea in normal-renal function sickle cell patients to those of patients with~     glomerular hyperfiltration or moderate renal failure.~   "
40867|NCT02522091|"~     Investigators propose in this study to evaluate prospective memory (MP) in all its~     complexity as well as the processes, cognitive and brain, the underlying. Specifically,~     investigators propose to evaluate the evolution of the MP during normal aging and~     Alzheimer's disease (AD) to identify the cognitive and brain processes underlying this~     development. To do this, this study will have to include healthy subjects, 18 to 95 years,~     patients with Mild Cognitive Impairment (MCI) and patients with probable AD. All~     participants will undergo a series of examinations, both neuropsychological and brain~     imaging.~   "
40868|NCT02522078|"~     This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine~     evacuation increases the dilatation of uterine cervix compared to dry misoprostol~   "
40869|NCT02522065|"~     The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating~     part of the condition. Current methods to evaluate this impairment rely on subjective~     examinations. The investigators seek to develop an objective assessment of motor deficits by~     monitoring the participants natural interactions with a keyboard (on a computer or smart~     device). This approach provides a window to how the brain behaves during typical daily use~     of these devices, i.e. writing a report, sending an email or any other task performed on a~     digital device and thus has the potential to be used easily and regularly. (Importantly, the~     data gathered are non-sensitive and based only on timing information).~      PD participants will be recruited during outpatient visits to PD clinics throughout the~     Madrid metropolitan region. General entry criteria will be those patients who are scheduled~     to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact~     on participants' standard clinical management other than by asking the participants to type~     for 15 minutes at each of 3 clinic visits, and installing the investigators proprietary~     software on their home computer. This software will collect keystroke data alone. (None of~     the actual information about what is being typed will be collected.) The keystroke data~     collected will be analyzed and compared with standard clinical metrics of therapeutic~     response, as well as the in-clinic typing data.~   "
40870|NCT02522052|"~     Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large~     proportion of patients with established disease have persistent high disease activity in~     spite of existing effective pharmacological treatment. Improved treatment is thus urgently~     needed, including alternative treatments in addition to optimal pharmacological therapy. The~     main purpose of this study is to investigate if a high intake of blue mussel (Mytilus~     Edulis) could decrease inflammation and disease activity in patients with established RA. A~     secondary goal is to identify novel biomarkers for blue mussel intake and metabolic~     responses to this diet, using a metabolomics approach with high sensitivity and specificity.~     A third goal is to look at genetic polymorphisms in relation to long chain polyunsaturated~     fatty acids (LCPUFA) and inflammatory markers.~   "
40871|NCT02522039|"~     Investigation of the effect on the pupillary constriction by latanoprost,~     dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.~   "
40872|NCT02522026|"~     Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as~     well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined~     regarding different clinical and blood/ sputum derived biomarkers at the investigators'~     research center. This observation study will follow-up/re-examine all available subjects~     regarding disease course and treatment changes after 3 years (+/-6 months) for the~     investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease~     progression. In addition, biobanking of respective biosamples for potential future COPD~     biomarker research will be conducted.~   "
40873|NCT02522013|"~     Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its~     clinical manifestations are pain in the forehead and the occipital region, or diffuse~     headache. The pain is dull or fluctuating, becoming worse when standing and better when~     lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing~     loss, photophobia, and nausea, which cause great suffering to the patients1. According to~     epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture~     suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for~     PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and~     the application of an epidural blood patch. The efficacy of theophylline has been proven in~     a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection~     of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were~     significantly different compared with those of the placebo group5. At present, the clinical~     application of theophylline has been replaced by aminophylline and doxofylline, and it is~     difficult to purchase theophylline in most hospitals in China and other countries.~      The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a~     prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and~     safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients~     were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or~     sterile isotonic saline.The investigators estimate that this trial will demonstrate that an~     IV injection of aminophylline could be the preferred method for the clinical treatment of~     PDPH.~   "
41074|NCT02519387|"~     This is a phase IV, open-label and single-arm study of patients with non-malignant pain due~     to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not~     responding to non-opioid analgesics. The primary objective was to assess the efficacy of~     buprenorphine transdermal patch for pain control among these patients.~   "
40874|NCT02522000|"~     Functional dyspepsia (FD) is a heterogeneous disorder with multifactorial pathophysiology.~     Patients with FD have visceral hypersensitivity to mechanical and chemical stimuli. Several~     previous studies have described an increased chemosensitivity to oral capsaicin ingestion.~     Capsaicin is a natural agonist of TRPV-1 receptors present on afferent sensory neurons.~     Activation of the TRPV-1 receptor by capsaicin or other agonists results in the release of~     several neuropeptides (i.e. substance P, somatostatin). Besides, increased duodenal~     permeability and disruption of tight junction structure in FD patients compared to healthy~     volunteers has been reported in a recent study. In this observational study investigators~     will evaluate the role of the TRPV-1 neuropeptide pathway in patients with functional~     dyspepsia and healthy controls.~   "
40875|NCT02521987|"~     The purpose of this study is to determine if there is a difference in pain perception by~     participants when the assistant port size varies by 50% (8 mm to 12 mm).~   "
40876|NCT02521974|"~     Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE~     recommendations at the time of writing this protocol. After this cessation of OPV2,~     stockpiles of mOPV2 will be maintained for potential use if necessary in response to a~     future outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low~     population immunity. Research is ongoing to develop vaccines that are genetically more~     stable than the currently available Sabin 2-containing OPVs. To generate data on~     immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future~     comparator for new polio vaccine research after the global switch from tOPV to bOPV, this~     study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal)~     and genetic stability endpoints of mOPV2 in children aged 1 to 5 years and in infants~     approximately 18 weeks of aged vaccinated with bOPV-/IPV for better understanding of the~     stockpile use of this vaccine, and for comparison with any potential new polio vaccine with~     a type 2 component in the future.~   "
40877|NCT02521961|"~     This randomized clinical trial studies a support group program in improving quality of life~     in underserved urban Latina breast cancer survivors. A psychosocial support group program~     may help reduce distress and improve health-related quality of life in underserved urban~     Latina breast cancer survivors.~   "
40878|NCT02521948|"~     The purpose of this study is to evaluate the safety and performance of the MANTA Vascular~     Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular~     procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite~     Europeenne--European Conformity) and other regulatory submissions. The study will assess~     whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after~     interventional procedures.~   "
40879|NCT02521935|"~     Purpose: To compare complete denture outcomes between conventional and digital denture~     fabrication processes.~      Participants: Sixteen edentulous adult patients in the University of North Carolina School~     of Dentistry Student Clinic who are seeking removable complete dentures.~      Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one~     using the conventional process (A) and the other using a digital process (B). Variability~     will be assessed by the research team, the treating dental students, an independent~     prosthodontist, and the patients through quantitative measures. Case selection and results~     analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.~   "
40880|NCT02521922|"~     To assess the feasibility and usability of the VSP System in the in-patient hospital setting~     to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be~     incorporated into the study site's Information Technology infrastructure.~   "
40881|NCT02521909|"~     The purpose of this study is to compare the accuracy of different apex locators. Before root~     canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the~     root canal and to locate its opening at the tip of the tooth's root (called the apical~     foramen). A root canal is the space inside the root of a tooth. If the tissue within the~     root canal becomes infected, dentists may perform root canal therapy.~   "
40882|NCT02521896|"~     The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in~     facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal~     atrial fibrillation and persistent atrial fibrillation (AF). The study will be a~     prospective, single-center, non-randomized investigation.~   "
40883|NCT02521883|"~     The aim is to investigate the safety and effectiveness of transcranial Direct Current~     Stimulation (tDCS) in patients with moderate to severe major depression compared to patients~     treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.~      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.~   "
40884|NCT02521870|"~     This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety,~     tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections~     in combination with intravenous pembrolizumab in patients with metastatic melanoma or~     recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).~      Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or~     intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with~     metastatic melanoma.~      Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy~     and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC~     populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be~     recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy~     naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.~   "
40885|NCT02521857|"~     This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS~     5461.~   "
40918|NCT02521415|"~     This single center, randomized control, double blind trial will prospectively examine the~     feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for~     pain control in the pediatric emergency department setting. The investigators hypothesize~     that IN ketamine may provide a safe and effective alternative to IN fentanyl for children~     with suspected, isolated extremity fractures.~      Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires~     analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the~     emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.~   "
41075|NCT02519374|"~     Assessment of the digestive tolerability of the PROMITOR® .~   "
40886|NCT02521844|"~     This is a Phase 1A/B study consisting of two parts. Part A is a non-randomised, open-label,~     sequential evaluation of the safety, pharmacokinetics, MTD, and RD of ETC 1922159 in~     patients with advanced or metastatic, or unresectable solid malignancies, for whom no~     approved treatment option or standard of care is available. Dose escalation, with the goal~     of identifying the MTD and RD, will be guided by an oCRM model with a cohort size of one~     patient.~      Part B will be a non-randomised, non-comparative, open-label evaluation of the safety and~     tolerability of the RD of ETC 1922159 in patients with advanced or metastatic, or~     unresectable solid malignancies, for whom no approved treatment option or standard of care~     is available, with a molecular phenotype that is expected to make them sensitive to PORCN~     inhibitor treatment.~      It is anticipated that the study will take approximately 30 months to complete~     (approximately 18 months for Part A and approximately 12 months for Part B).~   "
40887|NCT02521831|"~     Significant concern regarding the safety of general anesthesia in children has arisen due to~     myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents.~     Inflammation of the central nervous system after anesthesia may have a significant role in~     the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the~     investigators propose to randomize healthy infants undergoing elective surgery to one of two~     anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with~     isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal~     block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and~     secondary endpoint will be neurocognitive outcome at 6 months and 1 year.~   "
40888|NCT02521818|"~     This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins~     diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease~     (AD) living in the community. A secondary aim is to determine whether adherence to the MAD~     results in better cognitive test scores than adherence to a non-ketogenic control diet. A~     final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants'~     response to the MAD. Participants will be randomly assigned to a 12-week trial of either the~     MAD or a placebo diet based on the National Institute on Aging's recommendations for senior~     nutrition.~   "
40889|NCT02521805|"~     A randomized cross-over meal study will investigate the effects of protein quality and a~     combination of dietary fibre and protein on appetite regulation.~      The study will use basic measures of ad libitum energy intake and visual-analogue scales of~     appetite (study A). A sub-study (study B) will additionally include blood collection from 15~     of the 40 participants to investigate biological markers targeted satiety.~      The study days will be conducted at least one week apart to eliminate carry over effects. In~     the sub-study, the study days will be at least two weeks apart due to blood collection.~   "
40890|NCT02521792|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and~     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue~     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict~     movement by locking joints leading to cumulative loss of function and disability. Mouse~     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists~     such as palovarotene to prevent HO following injury. This 36-month study will evaluate the~     long-term safety and efficacy of episodic treatment with palovarotene for flare-ups in FOP~     subjects who successfully complete two flare-up treatment periods (6 weeks duration) and two~     follow-up periods (6 weeks duration) in Study PVO-1A-202.~   "
40891|NCT02521779|"~     The purpose of this study was to determine the effect of different dietary fats (saturated~     or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The~     investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase~     postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial~     endotoxemia.Participants were recruited via email and randomized to treatment meal in this~     single-blind, cross-over study. Each test session participants reported to the laboratory~     right away in the morning. An indwelling catheter was inserted into the participant~     non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant~     was then provided with one of four test meals (a porridge-type meal containing a different~     dietary fat), which they ate in entirety within 15 minutes. The participants remained in the~     laboratory for the next five and a half hours and were not allowed to consume any food or~     drink except water. During this time, further blood draws were taken at intervals of one~     hour for a total of five hours after the consumption of the test meal. Collected blood was~     processed on-site and the serum fraction collected and tested for endotoxin, inflammatory~     biomarkers, and metabolites.~   "
40892|NCT02521753|"~     Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive~     age women. PCOS is usually characterized by an excessive androgen production, menstrual~     irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying~     degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for~     these patients. Metformin has proven to be useful in IR and is frequently used in PCOS.~     However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon~     rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have~     been used in other IR states and may be useful in PCOS. The aim of this study is to asses~     the efficacy of these alternatives in obese PCOS patients.~   "
40893|NCT02521740|"~     Providing care for a disabled elderly may represent a risk for the health of the caregiver.~     The objective of the study is to assess the impact of caregiving in terms of clinical and~     biological markers in relation to disability and cognitive impairment.~   "
40919|NCT02521402|"~     The main purpose of this study is to see if there is clinical benefit of using Biovance in~     reduction of the recurrence of keloids when used to revise them. It will also assess the~     postoperative complications.~   "
40920|NCT02521389|"~     This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of~     3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group~     A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E)~     to assess alternative dose levels or formulations, if required.~      In each study part, each subject will receive a single dose of investigational medicinal~     product PWT-143 in each of 2 study periods (total of 2 single doses).~   "
40894|NCT02521727|"~     The risk of CRC in families of patients with CRC is well established, but it is less~     well-defined for families of patients with adenomas. Screening recommendations to families~     when an index subject has an adenoma on colonoscopy are not clear. Previous studies~     demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly~     limited by the lack of a suitable comparison group, did not offer colonoscopy to all~     relatives or did not have verification on true status of adenoma history in the relatives. A~     systematic review has reported that most studies cited for risk of CRC in relatives with~     adenomas have not addressed the intended question. Currently International guidelines~     recommended screening colonoscopy in close relatives and at a younger age when there is a~     proband with an adenoma, however this recommendation has not been fully supported by all~     societies due to the lack of robust evidence. This gap in knowledge highlights the need of~     well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in~     subjects who have first-degree relatives with adenomas.~      Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one~     adenoma. Based on current guidelines, nearly half the population will be counseled to~     undergo a colonoscopy from 40 years old based on a positive family history of adenoma. This~     will have enormous burden on the healthcare system if screening is implicated in all these~     individuals. Secondly, not all adenomas carry the same risk. Large or villous adenomas are~     associated with a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas~     small adenomas may be associated with a modest increased risk 19. It is therefore important~     to determine the risk of colorectal neoplasms in families of subjects with non-advanced~     adenomas to justify more intensive screening in these individuals. Investigators hypothesize~     that first-degree relatives of patients with non-advanced adenoma have an increased risk of~     both CRC and adenomas. Investigators aim to quantify this risk, and to identify other~     individual patient or neoplasm characteristics that may contribute to this increased risk.~     In addition, Investigators aim to determine molecular alteration profiles of colonic adenoma~     in siblings of patients with advanced neoplasm.~   "
40895|NCT02521714|"~     This study will evaluate the amount of drug that reaches the circulation when a subject~     takes the test (liquid) formulation compared to the reference (capsule) formulation. The~     study will also examine the effect of a high fat meal on the levels of drug in blood.~   "
40896|NCT02521701|"~     This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.~   "
40897|NCT02521688|"~     Investigators have shown the presence of elevated proinflammatory cytokines in amniotic~     fluid in patients in preterm labor.However, there is limited and mostly negative evidence~     that the elevation of these mediators in gingival crevicular fluid (GCF), and amniotic fluid~     are associated with pregnancy complications in periodontitis patients. Thus this case~     control study will be conducted to~        1. To determine the level of proinflammatory cytokines in gingival crevicular fluid in~          women with spontaneous preterm delivery with chronic periodontitis.~        2. To investigate the expression of macrophage inflammatory protein-1α in placental~          tissues.~        3. To assess the possible correlation between chronic periodontitis and preterm delivery.~   "
40898|NCT02521675|"~     There is no specific recommendations on the adjustments of the insulin treatment in the~     event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients~     often prefer additional carbohydrates intake rather than the reduction of their insulin~     doses because of the lack of specific algorithms.~      The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week~     of physical activity (PA), the incidence of hypoglycaemia is not different from that~     obtained during a week of rest without physical activity.~      It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D~     patients practicing an occasional AP.~      25 centers involved in this study.~      After agreeing to participate in the study, patients will read the information leaflet, ask~     questions to the investigator physician and they will date and sign the consent form. The~     investigator physician will do the same.~      They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in~     which they will realize the rest vs DIABRASPORT sessions.~      The study will take place in 5 weeks:~      During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of~     30 to 60 minutes separated by at least 24 hours:~        -  moderate activity 3 hours after lunch~        -  intense activity 3 hours after lunch~        -  activity moderate 90 min after lunch They will use their usual algorithms (Cho intake~          or adjustment of the dose of insulin) during the week Baseline and they will use the~          Diabrasport algorithm during the week Diabrasport.~      Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.~      During the week of rest, patients should do no physical activity during the week. They will~     be equipped with the Glycemic holter.~      Patients will have to fill a food survey the days they practice PA. Between each period, the~     patient must respect a period of wash-out for one week at least, during which he will be~     asked to not practice physical activity.~      Validation of algorithms simple, easy to implement, adaptable by patients, could help to~     improve balance metabolic and practice of sport among the T1D.~   "
40899|NCT02521662|"~     A randomised trial to determine whether e-cigarettes (with and without nicotine) combined~     with nicotine patches and behavioural support can assist smokers in remaining abstinent for~     at least six months.~   "
40900|NCT02521649|"~     An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or~     Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three~     injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension~     study period.~   "
40901|NCT02521636|"~     Investigators propose to conduct a prospective, randomized, controlled, multicenter~     assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on~     morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD)~     hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated~     pneumonia. The main objective is to show in patients hospitalized in intensive care for~     acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of~     difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.~   "
40902|NCT02521623|"~     An increasing number of women undergo an immediate breast reconstruction, where the~     mastectomy and the breast reconstruction are performed in the same surgery. To aid survival~     of the mastectomy skin flaps, and to provide better aesthetic results acellular dermal~     matrixes (ADMs) are used to reinforce the breast. There are several different types of ADM~     available for this purpose. In this randomized clinical trial, the following study will~     investigate two different types of ADM (Strattice™ and SurgiMend®) in an immediate breast~     reconstructive setting. Sixty patients will be allocated on a 1:1 ratio to receive either~     Strattice™ or SurgiMend® ADM. Patients scheduled for immediate breast reconstruction with~     ADM at pt. of Plastic and Reconstructive Surgery at Aarhus University Hospital, Aarhus,~     Denmark will be offered participation. In total, 60 patients will be included. Outcome~     parameters of interest are complication rate, patient satisfaction, aesthetic result and~     cost of the procedure. Satisfaction and aesthetic result will be measured at 4 and 12 months~     post surgery.~   "
40903|NCT02521610|"~     This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will~     evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week~     of RG7625 dosing in healthy male and female volunteers. Each participant will receive a~     single dose of RG7625 or placebo followed by one week of dosing with the same treatment.~     Each participant will also receive intradermal administration of 4 recall antigens at~     Screening and on Day 7 of treatment to assess study drug effects on delayed-type~     hypersensitivity (DTH).~   "
40904|NCT02521597|"~     To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children~     presenting with respiratory symptoms using a smartphone otoscope attachment compared with a~     classic otoscope.~   "
40905|NCT02521584|"~     Study the effect of ischemia time on patient and graft survival.~   "
40906|NCT02521571|"~     The Resilience Alliance is a skill-based staff development intervention for child protective~     staff that focuses on improving job satisfaction, resilience, optimism and social support,~     while decreasing attrition, stress reactivity and burnout. The investigators believe that~     the intervention will enhance the capacity of child welfare workers to care for themselves,~     which will result in them providing better care for the children and families involved with~     the child welfare system.~      The Resiliance Alliance will be implemented in two child protective offices, Manhattan Zone~     C and Brooklyn Zone B. Staff from two additional offices (Staten Island Zone A and Brooklyn~     Zone C) will serve as a control group. A web-based survey will be administered in the group~     receiving the Resiliance Alliance intervention prior to intervention, at completion of the~     intervention, and 3 months post completion. The control group will be given a two-part~     training (3 hours in total) on secondary traumatic stress. The control group will then be~     asked to complete the same survey as the intervention group.~   "
40907|NCT02521558|"~     The current study will examine the use of a mobile electronic application used to deliver~     cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to~     Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific~     cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them~     to complete. The goal of this study is to determine if a) patients are able to use and~     adhere to a cognitive rehabilitation program delivered to their mobile device and b) to~     determine if patients can improve their language, attention, and memory by completing~     cognitive rehabilitation tasks assigned to them.~   "
40908|NCT02521545|"~     The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061~     in the new oral formulation in the fasted state in healthy male and female volunteers. The~     secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in~     the new formulation in this study population.~   "
40909|NCT02521532|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise~     and decrease systemic blood pressure in multiple populations, including COPD. The chronic~     effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.~   "
40910|NCT02521519|"~     This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep~     intramuscular (PDI) injection for pain relief in chronic low back pain. Based on~     randomization in first intervention session, one side receives MBB and the other side takes~     PDI and in second session the pattern reverses.~   "
40911|NCT02521506|"~     Diabetes mellitus is one of the most prevalent disease in the western world. The control of~     glucose levels has a big impact in the prevention of diabetes complications. The measure of~     glucose levels in capillary blood with glucometers is the gold standard to measure and~     control the glucose levels. Nowadays the glucometers become to more precise and~     sophisticated devices. One of the most notables advance is the inclusion of software that~     cam predicts glucose trends. This software has not be tested in routine clinical practice.~   "
40912|NCT02521493|"~     This phase III trial studies response-based chemotherapy in treating newly diagnosed acute~     myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs~     used in chemotherapy work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Response-based chemotherapy separates patients into different risk groups and treats them~     according to how they respond to the first course of treatment (Induction I). Response-based~     treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in~     younger patients with Down syndrome while reducing the side effects.~   "
40913|NCT02521480|"~     To determine whether real TMS is more effective than sham TMS in reducing pain following~     surgery~   "
40914|NCT02521467|"~     Free gingival grafts are important to increase zone of attached gingiva and root coverage.~     This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal~     wound healing. The superior healing observed at the PRF membrane sites supports its use in~     accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious~     approach to protect the raw wound area of a palatal donor site to reduce healing time and~     patient discomfort.~   "
40915|NCT02521454|"~     Successful policing requires rapid and unbiased decision-making, well-developed emotion~     regulation skills, and psychological resilience. However, law enforcement officers (LEOs)~     are frequently exposed to intensive work-related stress and trauma, and consequently, are at~     elevated risk of adverse mental health outcomes. These mental health issues in turn are some~     of the primary mechanisms underlying other- and self-directed violence among LEOs. The~     excessive use of force by LEOs, including unjustified shootings, frequently captures~     national headlines and is considered by many to be one of the most serious and divisive~     human rights issues in the United States. Previous research suggests that LEOs can be~     impacted by various factors when making rapid decisions while using firearms, including a~     lack of careful consideration of contextual factors and unconscious racial stereotypes. This~     is especially true when their cognitive and emotional resources are compromised due to~     factors such as stress. Similarly, key precursors to suicide among LEOs include chronic~     stress, exposure to trauma, alcohol misuse, and depression. The substantial personal,~     social, and economic costs of LEO stress, including unjustified shootings and suicide,~     suggest a clear need for innovative and novel prevention programs to promote well-being and~     reduce violence. Given its demonstrated impact on many of the precursors to self- and~     other-directed violence among LEOs, one possible approach is an adapted Mindfulness-Based~     Stress-Reduction (MBSR) program, developed specifically for LEOs. Therefore, the primary~     objectives of this proposal are to: (1) assess the feasibility of recruitment, adherence to~     program intervention, and compliance with assessment instruments, and (2) determine the~     impact of an adapted MBSR program (Mindfulness-Based Resilience Training; MBRT) on~     precursors to other- and self-directed violence, and in promoting psychological resilience~     and emotion regulation among LEOs. There is promising preliminary evidence suggesting that~     mindfulness is an effective strategy for LEOs to decrease stress and its negative outcomes,~     enhance resilience and emotion regulation, and ultimately reduce other- and self-directed~     violence. The proposed project will test the impact of MBRT using a pilot feasibility~     randomized controlled trial (RCT). This research will generate important information on the~     feasibility of recruitment, adherence to program intervention, and compliance with~     assessment instruments, and data obtained through the proposed study will build on the~     investigators existing work to provide support for a larger RCT examining the efficacy of~     MBRT in reducing violence.~   "
40916|NCT02521441|"~     This was a randomized, open-label, active-controlled, dose-finding, phase II study to~     evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with~     breast cancer receiving myelotoxic chemotherapy.~      Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20~     mg/dose of F-627 or Filgrastim, in an equal ratio.~   "
40917|NCT02521428|"~     The purpose of this retrospective observational study is to describe the sequence of~     ICU-therapies that are limited and to compare characteristics and the decision making~     process in surgical ICU-patients.~   "
40922|NCT02521363|"~     The purpose of this study is to test the safety and feasibility of placing and removing a~     small device that contains anti-cancer drugs in a breast tumor of patients who plan on~     having breast surgery without treatment prior or patients who plan on receiving standard~     preoperative chemotherapy prior to their breast surgery. This device may be able to predict~     what types of treatment work best against an individual's breast cancer. With this device,~     the investigators hope to be able to personalize treatment choices based on an individual's~     type of breast cancer.~   "
40923|NCT02521350|"~     In the last few years, acute renal injury (AKI) definition has been significantly changed.~     In the light of the data obtained from multicenter international studies, acute renal injury~     was redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three~     criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 %~     increment of respective basal value of serum creatinine.~      In the current study, older than 40 years patients with no specific gender, who will stay at~     least one night in hospital will be included and cardiovascular and urological surgery~     patients and patients with known renal insufficiency will be excluded. It was aimed to~     measure serum creatinine levels in all included patients at baseline and up to 24h after~     surgery and will be determined acute kidney injury incidence and risk factors according to~     new criteria.~   "
40924|NCT02521337|"~     Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation.~     The incidence of preterm birth in Israel in the last years is around 7-8%.~      Despite various diagnostic modalities as well as newly therapeutic approaches the incidence~     of preterm birth remains unchanged and is considered to be the leading cause of neonatal~     morbidity and mortality.~      In the last decade, small RNAs have emerged as an important player in both physiological and~     pathophysiological responses. These single strands, non-coding regulatory RNA molecules are~     responsible for post transcriptional regulation of target genes. Hence, may provide a new~     opportunity for biomarkers discovery in the field of preterm birth.~      The main objective of this study is to identify a distinctive expression profile of maternal~     circulating RNAs that will be used as biomarkers for preterm birth.~   "
40925|NCT02521324|"~     The current study is designed to evaluate the effect of device guided breathing (DGB) on~     sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve~     their sleep quality will be included in this study. The subjects will receive a belt type~     breathing sensor, download the app on their smartphone, and will be required to perform DGB~     at their home setting for 2 weeks after a baseline period.~   "
40926|NCT02521311|"~     The main purpose of this study is to assess clemastine as a remyelinating agent in patients~     with acute optic neuritis.The study will also evaluate the tolerability of clemastine,~     originally approved as first-generation antihistamine, in patients with optic neuritis.~     Study procedures will include assessments for evidence of remyelination in the anterior~     visual pathway and in the brain using electrophysiologic techniques and magnetic resonance~     imaging. If they are on one, patients in this study can remain on their standard disease~     modifying treatment during the course of the study. However, patients cannot participate in~     any other investigational new drug research study concurrently.~   "
40927|NCT02521298|"~     This study investigates the treatment effect on lateral elbow tendinopathy of strength~     training in combination with cortico-steroid injection, dry-needling or placebo in a~     double-blinded randomized controlled trial.~   "
40928|NCT02521285|"~     This randomized phase II trial studies the safety of and how well aspirin works in~     preventing Barrett's esophagus from returning after it has been successfully eliminated by~     radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus~     for the levels of a specific protein that is linked to developing Barrett's esophagus may~     help doctors learn whether aspirin can prevent it from returning after it has been~     successfully treated.~   "
40929|NCT02521272|"~     The aim of the study is to investigate respiratory parameters of a person in the simulated~     avalanche snow and consequent use of the measured data for development of a~     mathematical-physical model of breathing during increasing hypercapnia in the avalanche.~   "
40930|NCT02521259|"~     This study evaluates the association between the depth of general anesthesia and the~     occurrence of EA. The investigators hypothesized that optimal level of anesthetic depth~     could decrease the incidence of EA in children undergoing strabismus surgery compared to the~     deep level of anesthetic depth.~   "
40931|NCT02521246|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
40932|NCT02521233|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
40933|NCT02521220|"~     Some studies have reported improved vascular function with the supplementation of L-arginine~     in participants with cardiovascular disease (CVD). Several clinical studies have also begun~     the investigation of L-arginine supplementation in participants with peripheral artery~     disease (PAD). This is particularly important as currently there are limited options~     available to medically manage intermittent leg pain resulted from PAD. Although some of~     these short-term clinical trials suggested that oral L-arginine improved walking distance or~     improved walking speed in participants with PAD, these results were not consistent. Further,~     only 1% of the oral supplemented L-arginine is available for the NO production as the rest~     is metabolised by the body. A better way to provide the body with substrate to produce NO is~     therefore needed. The natural amino acid and food component, L-citrulline has been suggested~     to be a good candidate for this purpose.~      L-citrulline, named after watermelon citrullus vulgaris from which it was first isolated, is~     a natural precursor of L-arginine. Studies have shown that L-citrulline is metabolised by~     the body to a lesser degree compared to L-arginine and hence is an effective precursor of~     arginine in peripheral tissues, including endothelial cells. Oral L-citrulline~     supplementation also eliminates some of the unwanted effects associated with oral arginine~     supplementation and it is well tolerated without known side effects. In addition,~     L-citrulline is a supplement that is available over-the-counter. Thus, oral supplementation~     of L-citrulline may be a new intervention strategy in participants with PAD.~      The investigators hypothesize that the oral food supplement L-citrulline, unlike L-arginine,~     reverses endothelial dysfunction. In a multinational, multicenter, double blinded,~     randomised, placebo-controlled cross-over trial the effects of L-citrulline in peripheral~     artery disease will be investigated.~   "
40954|NCT02520947|"~     213 patients undergoing elective on-pump coronary artery bypass grafting (CABG) were~     enrolled into this prospective-clinical trial.After hundred and sixty three patients were~     excluded due to various reasons, 50 patients were randomized to BIS (bispectral index) and~     MAC (minimum alveolar concentration) groups. In BIS group (Group B, n=25), desflurane was~     titrated within 40 to 60 BIS values and in MAC group (Group M, n=25) within 0.7 to 1.3 MAC.~     Primary end point of the study was to investigate the difference of desflurane consumption~     between groups.~   "
40955|NCT02520934|"~     evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on~     Gaucher disease~   "
40934|NCT02521207|"~     The study will compare the study drug to an already marketed formulation of prescription~     strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by~     the body and also by performing a specialist procedure called an endoscopy (or more~     specifically, a gastroscopy). The safety and tolerability of the study drug will also be~     assessed.~      The study will consist of 2 parts involving up to 54 healthy male and female subjects.~     Subjects will be randomly assigned to receive either the study drug or reference product.~     Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of~     800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001~     or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on~     progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or~     Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach~     irritation using endoscopy.~   "
40935|NCT02521194|"~     The goal of this research study is to learn if inpatient occupational therapy can help~     patients in the Palliative Care Unit (PCU).~   "
40936|NCT02521181|"~     The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight~     (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney~     failure in people with chronic kidney disease. However, the dose to prescribe in order to~     test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will~     help determine the best dose of sodium bicarbonate to prescribe in a future study that will~     test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve~     kidney function in individuals with chronic kidney disease.~   "
40937|NCT02521168|"~     A condition of decreased serum T3 level in children after cardiac surgery using~     cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This~     syndrome has been closely associated with low cardiac output syndrome after heart surgery.~     The unique characteristics of pediatric patients with congenital heart disease (CHD) in~     Indonesia have caused ESS to arise in the population even before surgical managements.~     Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial~     function occurred through the improvement of mitochondrial effectiveness as the body energy~     source by utilizing effective energy substrates, lactate and pyruvate. Prevention of~     decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial.~     Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies,~     oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar~     study on pediatric population, however, has not been elucidated.~   "
40938|NCT02521155|"~     The purpose of the investigators' study is to assess effectiveness of community based oral~     health literacy intervention promoting positive oral hygiene self-care behavior among~     Montreal's Punjabi immigrants.~   "
40939|NCT02521142|"~     Age-related macular degeneration (AMD) is the leading cause of severe and irreversible~     visual loss and classified blindness in the elderly throughout Europe and the US. Among~     these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are~     responsible for the most severe visual loss. There is now convincing evidence that vascular~     endothelial growth factor (VEGF) is a major trigger for the formation of pathological~     choroidal vessels, responsible for the development of the neovascular form of AMD. Today,~     the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography~     using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into~     a vein of the arm. In the recent years tremendous enhancements in the field of optical~     coherence tomography have been achieved. These developments made it possible to visualize~     the retinal vasculature in a full depth manner without the application of an intravenous~     marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with~     non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and~     previously treated AMD patients.~   "
40940|NCT02521129|"~     The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track~     ablation device for liver biopsy.~   "
40941|NCT02521116|"~     To date two different instruments are commercially available to measure retinal oxygen~     saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal~     oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up~     to now no data comparing both instruments for the measurement of retinal oxygen saturation~     and vessel diameter are available in the literature.~      Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy~     subjects and patients with diabetic retinopathy or retinal vein occlusion between 2~     commercially available systems (DVA, Oxymap T1)~      Study design: Open pilot study~      Study population:~      30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate~     non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein~     occlusion, age 18-80 years~      Topically administered medication:~      Tropicamide (Mydriaticum Agepha®, Agepha, Vienna, Austria), dose: 1-2 drops per study day~     for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein~     (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements~     of intraocular pressure Nonylacidvanillylamide combined with~     Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG,~     Vienna, Austria): topical on the earlobe~      Methods:~      Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation~     tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from~     earlobe~      Main outcome variables:~      Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1~      The motive for this investigation is to compare data between 2 commercially available~     instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in~     healthy subjects as well as in patients with ocular disease associated with altered retinal~     oxygenation. Comparative data from both systems are currently not available. Data from this~     study will allow the comparison of studies performed with different systems. All oxygen~     measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears~     to be acceptable.~   "
40942|NCT02521103|"~     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical~     evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for~     revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the~     eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected~     to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments~     at 2 years postoperative.~   "
40943|NCT02521090|"~     This phase I/II trial studies the side effects and best dose of epidermal growth factor~     receptor bispecific antibody (EGFRBi)-armed autologous T cells and how well it works in~     treating patients with glioblastoma that have come back or does not respond to treatment.~     EGFRBi-armed autologous T cells coated with antibodies (proteins used by the immune system~     to target and kill foreign objects such as cancer cells) may have great ability to seek out,~     attach to, and destroy glioblastoma cells.~   "
40944|NCT02521077|"~     This is a parallel-track, randomized study will observe whether intravenous ascorbic acid~     reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for~     early stage breast cancer.~   "
40945|NCT02521064|"~     Children with Crohn's disease can be effectively treated by remaining on a single-formula~     diet for 8 continuous weeks. This dietary therapy is known as exclusive enteral nutrition~     (EEN). It is just as effective as steroid treatment, which is what's traditionally used for~     the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated.~     One possibility is that it changes the bacteria in our intestines, which allows the~     intestine to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a~     disease that is very similar to Crohn's disease. The purpose of our research project is to~     determine whether EEN can be used to treat ulcerative colitis, and understand how the~     intestinal bacteria changes while on EEN. Investigators will compare the results to patients~     who have either Crohn's disease or ulcerative colitis, and are receiving standard treatment~     for their disease (steroids). This is a pilot study, meaning that the goal of this study is~     to determine whether a larger study is feasible. Investigators will measure patient~     recruitment rates, whether patients are able to perform the treatment as requested, whether~     there are any safety concerns, and whether investigators are able to collect the bloodwork~     and stool samples without difficulty.~   "
40946|NCT02521051|"~     This research study is evaluating two drugs, alectinib and bevacizumab, as possible~     treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).~   "
40947|NCT02521038|"~     Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment.~     P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of~     the platelet activation, and is applied to the current practice protocol. Ticagrelor is a~     well-performing P2Y12 receptor blocking agent which is used in these patients. In the same~     matter, it is essential to prescribe the exact dosage to optimize efficacy within the safety~     limits. However current studies are based on Western countries, whereas there has been no~     Ticagrelor patient registry in East-Asia. Thus it is reasonable to study the use of~     Ticagrelor in a large registry of Korean ACS patients.~      The BK registry is a Prospective, Open-label, Multi-center, Real world, Registry, with~     prospective registration of patients receiving the medication, Ticagrelor. All subjects are~     to be followed up for 18 months after diagnosis and treatment for ACS.~      The purpose of this study is to observe and register clinical data including Major Adverse~     Cardiovascular Endpoints and any total bleeding occurrence in Korean ACS patients treated~     with Ticagrelor during 18 month follow-up. Also, the purpose includes to determine~     compliance of Ticagrelor during post-approval commercial use and to determine prescription~     pattern of Ticagrelor during post-approval commercial use.~   "
40948|NCT02521025|"~     In the present study, the investigators will assess the impact of two different feeding~     patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following~     bedrest.~   "
40949|NCT02521012|"~     Depression affects 350 million people worldwide. In the light of the global disease burden~     statistics, the efficacy of current treatments for depression appears insufficient. Thus,~     research on novel treatment interventions and predictors for good treatment response are~     warranted. Earlier prospective follow-up studies and intervention studies suggest that~     several bio-psychosocial factors, including high serum concentrations of vitamin D, are~     related to better treatment outcomes. In this follow-up study with randomized clinical~     vitamin D supplementation trial on patients with depression, the investigators aim to~        1. clarify how a six-month intervention with vitamin D supplementation affects treatment~          response, recovery, and the biological pathways related to depression. This aims to~          finding potential sub-groups getting benefits from vitamin D supplementation. In~          addition, the investigators want to~        2. investigate and characterize factors related to recovery from depression and working~          ability in depression patients in the long-term. The investigators are especially~          interested in the bio-psychosocial factors and the aims include examining both the~          individual's positive resources.~      The trial will start with a six-month double-blinded randomized controlled trial with~     vitamin D supplementation. The aim is to recruit altogether 3028 patients with~     non-psychotic, unipolar depression, aged 18-65 years, who are referred to the recruitment~     sites for treatment for depression. The participants will be randomized to low (10 µg/day)~     or high (100 µg/day) vitamin D supplementation group. Clinically necessary antidepressant~     treatments will continue during the intervention as needed. After six months of~     intervention, the participants will be followed up at 18 months and at 5 years.~      Several measurements will be conducted during the intervention and follow-up period.~     Participants will fill a variety of clinical questionnaires and questionnaires with~     background information. All participants give blood samples for biomarker analyses at time~     points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and~     anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.~   "
40950|NCT02520999|"~     Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid~     infusion, external pressure can be used. The investigators will study correlation between~     external pressure and hemolysis and deformability of red blood cell.~   "
40951|NCT02520986|"~     In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata,~     two surgical methods, the carbon dioxide laser Ablation and the excision by~     electrocoagulation, will be compared. The primary outcome of the study is the cosmetic~     result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale~     (VAS), secondary outcomes are intervention time, operative complications, subjects and users~     satisfaction, postoperative pain and recurrence of genital warts.~   "
40952|NCT02520973|"~     Pregnant women who develop active TB are at increased risk of poor maternal and infant~     outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have~     active TB , many with advanced disease, contributing to the 40% of maternal mortality~     associated with TB or HIV in South Africa . Screening for TB in pregnant women in this~     setting is therefore essential to reduce maternal mortality. Symptom-directed screening for~     TB has been recommended by the World Health Organization and by the South African National~     Department of Health; however, no implementation framework is in place to operationalize the~     guidelines. Symptom-based testing is an efficient process that limits use of diagnostic~     tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected~     women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we~     found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of~     symptoms, was performed; most TB cases were newly diagnosed among women who reported no~     symptoms .~   "
40953|NCT02520960|"~     Prospective observational multicentric study evaluating the efficacy of considering unipolar~     signal modification during radio frequency catheter ablation of patients with symptomatic~     paroxysmal atrial fibrillation in France between November 2013 and January 2015. All~     procedures were conducted according to the standard clinical care and current guidelines.~     Pulmonary vein isolation was guided according to force (at least 10 grams) and application~     vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording~     became a complete positive signal. Patients were discharged from hospital free of any~     anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed~     by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.~   "
40956|NCT02520921|"~     To compare treatment with enteric coated aspirin twice a day (100 mg in the morning and 100~     mg in the evening) versus enteric coated aspirin 100 mg once per day on a composite~     end-point of ischemic events in diabetic patients with acute coronary syndrome.~      It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic~     event after acute coronary syndrome in diabetic patients.~   "
40957|NCT02520908|"~     Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic~     variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF~     typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs~     share a very bad prognosis: Patients usually show early relapses after chemotherapy,~     prolonged complete remissions exceptionally occur and quality of life is severely affected.~     Several publications have reported durable responses following allogeneic hematopoietic stem~     cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role~     of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective,~     multicenter, controlled study will compare the outcomes of patients who receive~     reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated~     donor to those of patients who receive standard of care in patients with advanced-stage ETCL~     with poor prognostic features, will be performed. Patients are included at the time of donor~     search irrespective of the results, and compared on a donor versus no donor basis. It is an~     observational study since no intervention is made except the comparison of outcomes of~     groups that receive usual care (HSCT if donor available, or not).~   "
40958|NCT02520895|"~     RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire~     diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and~     chronic lymphocytic leukemia before and after treatment, and to evaluate the association of~     these parameters with clinical patient data and outcomes.~   "
40959|NCT02520882|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in~     glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will~     be injected intravenously. Visual and semiquantitative method will be used to assess the~     PET/CT images.~   "
40960|NCT02520869|"~     All patients will go through an ICSI (intracytoplasmic sperm injection)cycle Monitoring: COH~     (controlled ovarian hyperstimulation) will be monitored by transvaginal sonography, and then~     the dose of gonadotropin will be adjusted according to the follicle size and number.~      Triggering ovulation: when three or more follicles reach >18mm, endometrium triple line~     >8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of~     hCG(human chorionic gonadotropin ) will be given.~      Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte~     retrieval. Luteal phase support: with 100 mg progesterone injection IM daily until the day~     of the pregnancy test pregnancy test: 15 days after the embryo transfer. Semen collection~     and preparation Semen samples will be collected by masturbation in clean containers, usually~     after 2-3 days of abstinence. Each sample will be allowed to liquefy for at least 20 min at~     37 °C.~      Semen analysis:~      Basic sperm parameters including sperm count, concentration, motility and morphology will be~     evaluated according to World Health Organization guidelines. After the initial assessment,~     ejaculates will be divided into three aliquots. An aliquot of each sample will be used to~     assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n~     30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in~     each sample to measure the difference in DNA damage after processing in each technique then~     spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic~     stain and a light microscope and will be scored according to WHO~   "
40961|NCT02520856|"~     Hypertrophic cardiomyopathy (HCM) is an autosomal dominant disease characterized by~     unexplained hypertrophy of the left ventricle, often with predominant involvement of the~     interventricular septum, and characterized by myocyte disarray and fibrosis.~      HCM is the most common familial heart disease with strong genetic heterogeneity,~     demonstrated over the past 20 years. Mutations in 11 or more genes encoding proteins of the~     cardiac sarcomere are responsible for (or associated with) HCM.~      However, 30-40% of sporadic and familial cases of HCM are still genetically unlabelled. In~     addition, secondary HCM caused by Fabry's disease or amyloidosis, may mimic primary HCM and~     may be under diagnosed. This may result in a delay in accurate diagnosis and instauration of~     specific treatment, with possible clinical consequences for the patients.~      For these reasons, we decided to apply a new diagnostic strategy for patients with newly~     diagnosed HCM, including the whole exome sequencing (WES) technology.~      If correctly applied, this new technology has the potential to strongly reduce the~     diagnostic wavering leading to earlier diagnosis and genetic counseling in sarcomeric HCM~     and rarer forms of secondary HCM including Fabry's disease and amyloidosis, and also~     specific therapy set-up in secondary forms of HCM. It should also allow identifying new~     genes responsible for HCM.~   "
40962|NCT02520843|"~     Crohn's disease is a chronic inflammation of all or part of the digestive tract,  from the~     mouth to the anus . .~      Cell therapy is a new and promising approach for the treatment of inflammatory disease~     including Crohn's disease and fistulas.~      Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open,~     non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and~     will be conducted over a period of 28 month.~      This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano~     refractory to conventional medical and surgical treatment, the safety and efficacy of local~     microinjection of autologous adipose tissue and SVF from microaspirate .~      The main objective is to assess tolerance and security. The secondary objective is to~     evaluate the effectiveness of this technique~   "
40963|NCT02520830|"~     Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in~     epidemiological studies.~      Dietary intervention studies with certain micronutrients have shown promising effects on~     surrogate parameters of vascular risk including blood pressure, endothelial function and~     cholesterol levels. Wild blueberries have gained attention due to their high content of~     phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular~     function and health when given over relevant time periods and in relevant populations is not~     known. Therefore, it is the overall hypothesis of the study proposal that chronic~     consumption of wild blueberries can improve endothelial function, a prognostically validated~     surrogate of cardiovascular risk.~   "
40964|NCT02520817|"~     Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability~     to function in daily life and may progress to overt Hepatic Encephalopathy. Patients with~     MHE were missed in clinical follow up and are more exposure to work accident. The aim of the~     present study was to assess the effects of oral supplementation of antioxidant and zinc~     gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.~   "
40965|NCT02520804|"~     The purpose of this study is to determine Acute kidney injury incidence between sterofundin~     and normal saline ; Resuscitation shock patients~   "
40966|NCT02520791|"~     This phase I trial studies the side effects and best dose of anti-inducible T-cell~     co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral~     T-cell lymphoma follicular variant or angioimmunblastic T-cell lymphoma that has returned~     after a period of improvement (relapsed) or has not responded to previous treatment~     (refractory). Monoclonal antibodies, such as MEDI-570, may block cancer growth in different~     ways by targeting certain cells.~   "
40967|NCT02520778|"~     This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax~     when given together and to see how well they work in treating patients with previously~     treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has~     spread to other places in the body or has not responded to previous treatment with initial~     EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving with osimertinib together with~     navitoclax may work better in treating EGFR-positive non-small cell lung cancer.~   "
40968|NCT02520765|"~     This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist~     Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.~   "
40969|NCT02520752|"~     Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of~     midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors~   "
40970|NCT02520739|"~     The Mediterranean diet, in which olive oil is the main source of fat, has shown to be~     protective for chronic degenerative diseases. These diseases, such as cardiovascular,~     cancer, and neurodegenerative, and even the aging process, are linked to oxidative stress~     and inflammation. Recently, the Prevention through Mediterranean Diet Study has provided for~     first time evidence of the benefits of the Mediterranean diet on the primary prevention of~     cardiovascular disease.~      Olive oil, besides its high content of a healthy fat, the monounsaturated (MUFA) one: the~     oleic acid, has minor components with bioactive properties. The minor components of virgin~     olive oil are classified into two types: the unsaponifiable fraction, defined as the~     fraction extracted with solvents after the saponification of the oil, and the soluble~     fraction which includes the phenolic compounds. The content of the phenolic compounds~     (polyphenols) of an olive oil depends of the variety of the olive fruit, the cultivar, the~     climate, the ripeness of the olive, and the type of processing. Virgin olive oils obtained~     from the first press of centrifugation of the olives are those with high phenolic content.~     On November 2011, the European Food Safety Authority released a claim concerning the~     benefits of the daily ingestion of olive oil rich in phenolic compounds, such as the virgin~     olive oil. Due to this, the need to optimize the olive oil processing in order to obtain~     high phenolic content olive oils is one of the current goals in terms of increasing the~     nutritional value of an olive oil. To obtain an optimized olive oil with high phenolic~     content (OHPCO) has been one of the achievements within the frame of the NUTRAOLEOUM~     Project.~      However, the healthy properties of the new olive oils (OHPCO and FOO), according to the~     Evidence Based Medicine must be tested in proper clinical randomized trials. New olive oil~     products need to be tested in front of the parental ones (i.e. virgin olive oil obtained by~     common procedures) in order to ensure that their healthy properties are highlighted. This is~     the purpose of the NUTRAOLEUM Study. In order to be able to obtain future health claims from~     EFSA or FDA, for the products, the investigators will also examine the bioavailability in~     humans of the active principles (phenolic compounds and triterpenes) of the olive oils, as~     well as possible basic mechanisms involved in the potential health benefits of the olive~     oils tested.~   "
40971|NCT02520726|"~     This is a randomized, double-blind, placebo-controlled study to determine whether~     administration of sertraline to patients who exhibit acute stress disorder secondary to~     severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).~   "
40972|NCT02520713|"~     This research study is evaluating the use of specialized testing of solid tumors including~     sequencing. The process of performing these specialized tests is called tumor profiling. The~     tumor profiling may result in identifying changes in genes of the tumor that indicate that a~     particular therapy may have activity. This is called an individualized cancer therapy (iCat)~     recommendation. The results of the tumor profiling and, if applicable, the iCat~     recommendation will be returned.~   "
40973|NCT02520700|"~     Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called~     actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp.~     A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is~     converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible~     light causes the degradation of PpIX resulting in the production of reactive oxygen species~     and then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply~     the visible light. The main draw back to treatment is pain. Recent studies have shown that~     daylight can be used as the source of visible light and is as effective as conventional PDT.~     Patients find this form of treatment less painful and therefore preferable. The reduction in~     pain seen in daylight PDT appears to be related to the fact that no significant quantity of~     PpIX accumulates prior to exposure to the light source and small quantities of PpIX are~     activated continuously during daylight exposure. The drawback of performing daylight PDT in~     Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight~     treatment times is 2 hours and it would be difficult for patients to stay outside in winter,~     spring and autumn. This study investigates the use of an artificial white light source, a~     Maquet PWD 50SF theatre-light, as an alternative.~   "
40974|NCT02520687|"~     High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with~     serious adverse outcomes for both mother and baby. Treatment options for the management of~     high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals~     have shown that supplementation with dietary nitrate, using beetroot juice, can~     significantly lower blood pressure and improve blood flow. This study aims to investigate~     whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure~     regulation in pregnant women with chronic high blood pressure, and will also determine~     whether this can improve blood flow across the placenta.~   "
40975|NCT02520674|"~     The purpose of this study is to assess the accuracy and reliability of smartphone~     ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential~     community screening programs.~   "
40998|NCT02520375|"~     The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in~     periodontitis patients as an adjunct to scaling and rootplaning.~   "
40976|NCT02520661|"~     The emergency department (ED) is a common source of acute illness care for older adults.~     Many older adults who are discharged home from the ED return within 30 days due to numerous~     challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home~     transition are identified, the health and financial costs will only increase as the older~     adult population doubles by 2040. This study will apply Coleman's Care Transitions~     Intervention to the ED-to-home transition by adapting the program to account for the unique~     aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes~     of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion,~     this study will provide empiric evidence regarding this innovative approach to help the~     rapidly growing older adult population remain healthy and independent after an ED visit.~   "
40977|NCT02520648|"~     The purpose of this trial is to investigate the immediate effects of neuro-lymphatic~     treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical~     and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.~   "
40978|NCT02520635|"~     The primary purpose of the study is to evaluate the efficacy and safety of supra-early~     post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with~     newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of~     supra-early post-surgery chemotherapy in release brain edema.~   "
40979|NCT02520622|"~     The primary aim is to determine the impact of using digital photographs on a mobile device~     versus printed photographs on skin self-examination rates. The ease-of-use and overall~     satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on~     melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be~     evaluated. The study involves patients in the Pigmented Lesion Clinic that have received~     total body photography for skin monitoring.~   "
40980|NCT02520609|"~     Background:~      Metabolism refers to the many chemical pathways by which various compounds, including food,~     are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD)~     have too much fat in their liver cells, but what causes it is unclear. One explanation is~     that people with NAFLD process food and metabolize it differently than people without NAFLD.~     Researchers want to compare how food is metabolized in people with and without NAFLD.~      Objective:~      To better understand how food intake influences the development and progression of NAFLD.~      Eligibility:~      People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome~      Healthy volunteers ages 18 and older~      Design:~      Participants will be screened with medical history, surveys, physical exam, and blood tests.~     This will have ultrasound of the abdomen. This uses sound waves to image internal organs.~      Participants will stay at the Clinical Center for 2 nights.~      They will fast he first night.~      On the second day they will:~      Have their metabolism monitored in a metabolism research room for 24 hours~      Have a catheter inserted into an arm vein for several blood tests~      Drink an Ensure Plus for breakfast~      Have solid meals for lunch and dinner~      Have several urine tests.~      The final morning, they will:~      Have more blood tests.~      Have a DXA test to measure the fat in the body. They will lie on their backs for 15-25~     minutes while an x-ray machine is positioned over areas of the body.~   "
40981|NCT02520596|"~     Red raspberries are a rich source of (poly)phenolic compounds, the main components being~     anthocyanins and ellagitannins. There is growing evidence linking consumption of these~     compounds with beneficial effects on human health. However, the mechanisms involved remain~     poorly understood principally because of a limited understanding of the bioavailability of~     ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the~     phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following~     acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of~     blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins.~     All urine excreted over 48 h after the ingestion of raspberries was collected and blood~     samples were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites~     were identified and quantified by ultra high performance liquid chromatography-mass~     spectrometry (UHPLC-MS).~   "
40982|NCT02520583|"~     To determine the effect of probiotic supplementation on the inflammatory response and~     subsequent performance following a muscle damaging exercise bout, a double-blind, randomized~     placebo controlled two-factor repeated measures design will be employed. The dependent~     variables for this study will include measures of performance as well as markers of~     inflammation in a single limb model. Participants who qualify for study participation will~     have their height, weight, and body composition assessed (skin fold) followed by baseline~     measurements for determination of isometric and dynamic strength. Initial limb will be~     determined randomly. Following baseline testing, participants will randomly be assigned to~     ingest either a probiotic or placebo. Supplementation will begin at least 24 hours post~     baseline testing. Twenty-one days after initiating supplementation, participants will again~     complete performance testing followed by an exercise bout known to elicit muscle damage and~     produce an inflammatory response. Participants will then repeat performance testing 24, 48,~     and 72 hours post muscle damaging bout. Blood samples for determination of markers of~     inflammation will be taken throughout study duration. Following a 3-week wash-out period (21~     days), participants will repeat the experiment following the alternate supplement regimen~     with the contralateral limb.~   "
40983|NCT02520570|"~     1. Investigate the application of ulinastatin in real practice clinic.(eg:population~          character, usage and dosage, course of treatment,etc )~        2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin,~          collect the main clinical manifestations, treatment, outcome, influence factors;~          provide evidence for improving the recommended medication plan of ulinastatin.~        3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide~          evidence for appropriate medication to administration department of health authority.~   "
41022|NCT02520063|"~     This study will test how well a new combination of three drugs (Letrozole, Everolimus, and~     TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior~     to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast~     cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an~     investigational drug that blocks the formation and growth of blood vessels that feed the~     cancer and promote its growth. The goal of this study is to investigate the safety and~     efficacy of this multitargeted approach in breast cancer.~   "
40984|NCT02520557|"~     The purpose of this study is to understand if people with certain genes are predisposed to~     develop severe skin reactions after they are administered Eslicarbazepine Acetate. Currently~     there is no information that suggests that certain individuals who use Eslicarbazepine~     Acetate are predisposed to develop severe skin reactions. However, previous research has~     shown that seizure medicines like carbamazepine (Tegretol®) and oxcarbazepine (Trileptal®,~     Oxtellar XR®) are more likely to cause severe drug related skin reactions in some people of~     Asian ancestry who have specific genes. These are genes found in an area of chromosomes~     called the Major Histocompatibility Complex. This association is called a genetic risk~     factor. The study objective is to compare information that is obtained from individuals with~     a history of seizure disorders who develop severe skin reactions while using Eslicarbazepine~     Acetate to a group of patients who also have a history of seizure disorders and do not have~     a history of a severe skin reaction after using Eslicarbazepine Acetate.~   "
40985|NCT02520544|"~     The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium~     cup survivorship over years.~   "
40986|NCT02520531|"~     Single-centre, prospective, randomized comparative study to compare the maximum flexion and~     Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation~     of all complications.~   "
40987|NCT02520518|"~     Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2)~     inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight~     (fat) loss, in addition to other health benefits, including decreased blood pressure,~     decreased inflammation, and decreased oxidative stress. It is unclear as to whether these~     health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.~   "
40988|NCT02520505|"~     This is a prospective randomized control, crossover trial to determine if supraovulation~     with clomiphene citrate and intrauterine insemination is more efficacious than expectant~     management in women with stage III or IV endometriosis who have recently undergone operative~     laparoscopy.~   "
40989|NCT02520492|"~     In patients at risk of increased intracranial pressure (ICP), ICP measurements require~     invasive transducers, usually with insertion of a catheter into the cranium, or through a~     spinal tap. These invasive modalities involve risks and pain and they can be done only in~     specialized care units, with a high associated cost.~      A novel method for detecting changes in ICP has developed recently. The auditory hair cells~     emit sounds and electric signals in response to sound, which can be easily detected and~     measured non-invasively with the help of a microphone probe placed in the external ear canal~     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)~     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within~     seconds.~      A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination~     of causes: the inflammatory reaction around the tumor, the mass effect of the tumor,~     secondary vascular changes, a change in the flow of CSF.~      The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the~     monitoring of intracranial tumors. It is then detected by using routine clinical signs, in~     combination with a standard imaging method (MRI), but still subjective.~      The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate~     whether the increase in ICP precedes tumor clinical worsening and / or imaging.~   "
40990|NCT02520479|"~     A phase 2 study was conducted of sandwich protocols, with earlier RT after an initial 2 of~     P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ),~     followed by further two consolidation cycles,to explore the appropriate mode of combined~     modality therapy (CMT) in early stage ENKTL.~   "
40991|NCT02520466|"~     The aim of the present study is to investigate whether the ingestion of a cocoa~     flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion~     and platelet function in patients with overt coronary artery disease acutely (after 2 hours)~   "
40992|NCT02520453|"~     Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer~     following neoadjuvant CCRT.~   "
40993|NCT02520440|"~     The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay~     and is associated with a worse prognosis.~      The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension,~     ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been~     demonstrated to be correlated with outcome, with higher scores indicating higher risk of~     death. However, GIF may be occult or clinical signs can go undetected in critically ill~     patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents,~     acute neurologic diseases, or delirium.~      Citrulline is a potential biomarker for small bowel function in critically ill patients with~     maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by~     the balance between gut synthesis and kidney degradation.~      GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF)~     through various mechanisms, and it is often associated with high intra-abdominal pressure~     (IAP). IAP greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF,~     including cardiac, respiratory and kidney failure. Studies have suggested that GIF can be~     the consequence rather than the cause of MOF.~      The aim of this study is to investigate if plasma citrulline levels is associated with a~     clinical diagnosis of GIF, and may predict the development of MOF.~   "
40994|NCT02520427|"~     The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a~     continuous IV infusion is safe and tolerable in adult subjects that have relapsed/refractory~     Acute Myeloid Leukemia, and to determine the maximum tolerated dose and/or a biologically~     active dose. The study will be conducted in multiple sites and test increasing doses of AMG~     330. The safety of subjects will be monitored by intensive assessment of vital signs,~     electrocardiograms, physical examinations, and laboratory tests.~   "
40995|NCT02520414|"~     The purpose of this study is to determine the safety and feasibility of using the Symphion~     system in an office setting.~   "
40996|NCT02520401|"~     This studies aims to investigate the effect of a probiotics in peri-implantitis patients as~     an adjunct to non-surgical therapy.~   "
40997|NCT02520388|"~     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in~     patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout~     period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of~     3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.~   "
40999|NCT02520362|"~     This is a prospective open cohort study with annual assessment and reporting of descriptive~     findings and a final report at the end of the study to address all study objectives. The~     study period will include 10 years of data accumulated in each data system. The study start~     date is the denosumab international birth date, 26 May 2010. The data end date will be 10~     years after the international birth date, 25 May 2020.The primary data sources will be the~     following:• US Medicare, including Parts A, B, and D• United HealthCare• Scandinavian~     national health registry databases, including data from Denmark, Sweden, and Norway. Data~     will be collected for postmenopausal women overall, women with Postmenopausal Osteoporosis,~     and patients who receive Prolia for unapproved indications. Among women with Postmenopausal~     Osteoporosis, exposure cohorts will be established based on exposure to denosumab or~     bisphosphonates. Nine adverse events of special interest will be identified using validated~     algorithms based on inpatient and outpatient diagnosis and procedure codes, and, for some~     AESI, medication codes or laboratory data. Selected AESI (osteonecoris of the jaw and~     atypical femoral fracture) will be confirmed by medical chart review.~   "
41000|NCT02520349|"~     The proposed research is a longitudinal human lab study to examine how measures of abuse~     liability and product appeal vary by e-cigarette device type, and how these lab assessments~     may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An~     additional aim is to evaluate e-cigarette safety and tolerability among smokers by device~     type.~   "
41001|NCT02520336|"~     Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in~     the postpartum period~   "
41002|NCT02520323|"~     The objective of this study is to determine the presence of bacterial species, and the~     immunologic and molecular mechanisms of granuloma formation that might be involved in the~     pathogenesis of sarcoidosis. The investigators will collect peripheral blood and~     bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and~     lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid~     lung disease, and healthy volunteers to directly compare the bacterial species present and~     the characteristics of cells thought to be involved in granuloma formation.~   "
41003|NCT02520310|"~     The objective of the study is to confirm the reproducibility of the evidence of safety and~     efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult~     for mitral valve surgery by the local site heart team.~   "
41004|NCT02520297|"~     The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe~     acute pain in patients presenting to the emergency department (ED) with a suspected/known,~     unilateral, closed long bone fracture.~   "
41005|NCT02520284|"~     This study will evaluate the efficacy, safety, and tolerability of GS-5745. It will consist~     of 3 parts: Induction Study (Cohort 1), and Maintenance Study (Cohort 2), and an Extended~     Treatment Phase.~   "
41006|NCT02520271|"~     Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital~     district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized~     follow-up study on depression and related substance use disorders (SUD). The study focuses~     on several aspects concerning the relation of depression and SUDs, the efficacy of selected~     assessment and treatment protocols, characteristics and genetics of the participants and the~     use of related biomarkers in clinical practice. The misused substance in focus is alcohol.~     In this study, dual diagnosis (DD) is defined as the simultaneous presence of clinically~     diagnosed major depressive disorder (MDD) and alcohol use disorder (AUD). The study was~     approved by the local ethics committee. Written informed consent was collected from all~     participants.~   "
41007|NCT02520258|"~     Experiments have shown that some artificial sweeteners like those in diet soda can cause~     changes in how the body responds to and uses sugar. These changes increase the chance of~     obesity, type 2 diabetes, and other metabolic diseases. In this study, investigators plan to~     see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet),~     causes these changes. Investigators believe that if metabolic changes are observed in a~     person who consumes aspartame, then removing all aspartame from the diet might lead to a~     reversal of the changes and a normalization of test results. New information about the~     effects of aspartame learned in this study might impact how sweetener additives are used in~     foods and might eventually lead to a decrease the incidence of obesity, diabetes, and~     metabolic syndrome.~   "
41008|NCT02520245|"~     This study has been designed to collect long-term follow-up information for patients who~     received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.~   "
41009|NCT02520232|"~     Alzheimer's disease (AD) is an irreversible, progressive brain disease. It is the most~     common form of dementia and the major cause of functional dependence in the elderly. Since~     there is currently no cure for Alzheimer's disease, a growing number of scientists pointed~     out the interest to use non-pharmacological alternative therapeutic approaches in order to~     slow down the decline of physical and cognitive resources and improve quality of life of~     patients with Alzheimer's disease. Several narrative and meta-analytical reviews suggest~     that regular practice of physical activity delays the occurrence of cognitive decline and~     slows down Alzheimer's disease progress when compared with sedentary people. Despite the~     growing interest of the scientific community for the positive effects of chronic exercise on~     mental health and cognitive functions, the clinical reality of this phenomenon remains to be~     clearly established, more particularly in aged people suffering from neurodegenerative~     diseases.The first aim of this research project is to test if chronic exercise reduces and~     even compensates for a cognitive decline in both patients with prodromal Alzheimer's disease~     (i.e., no dementia) and aging people with no pathology of central nervous system. The second~     aim of this research project is to examine whether an increasing of cerebral blood flow~     induced by chronic exercise can explain this positive effect.~   "
41010|NCT02520219|"~     The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human~     recombinant endostatin injection）combined with traditional GDP~     （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed~     PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.~   "
41033|NCT02519920|"~     This study was to test an appropriate dose of fluorescein sodium which can provide high~     image quality to ensure endoscopy examination and have no yellow dye in the skin by a~     randomized blinded controlled trial.~   "
41011|NCT02520206|"~     The investigators propose to conduct a translational study on the regulation of~     S-adenosylmethionine synthesis and cellular methylation reactions during chronic~     inflammation. Development of in vitro cell models may reveal the regulatory mechanisms by~     which specific inflammatory mediators cause metabolic changes and alter DNA methylation~     status. Metabolic and pharmacological studies in the in vivo models will enable us to better~     understand the regulation of inter-organ homeostasis of S-adenosyl methionine and help~     identify tissue specific biomarkers for methylation and epigenetic modifications in~     different stage of chronic inflammation. The clinical study in human subjects will help~     distinguish the impacts of autoimmune rheumatic disease, degenerated joint disease, or~     specific medication use on significant clinical and biochemical markers in folate and~     vitamin B6 metabolic pathways.The Investigators hope the present study can identify specific~     clinical markers for potential epigenetic changes in patients suffering from chronic~     inflammation, which will contribute to better clinical management of these diseases in~     humans.~   "
41012|NCT02520193|"~     The purpose of the present study is to compare usual care in terms of mobilization performed~     to intubated ICU patients to a standardized program designed to deliver early mobilization~     at least 5 days a week.~      This study has a before / after design with a control group during the experimental phase.~     The first phase of the study corresponds to an observational phase during which every act of~     mobilization performed to the included patients is going to be documented. During this first~     study period, total duration of mechanical ventilation is going to be recorded for all the~     patients included.~      At the end of this first study period, the participating ICU are going to be randomized~     (Cluster randomization) in two groups either observational or experimental. The~     corresponding strategy is going to be applied to all the patients included during the second~     study period. During this second period, total duration of mechanical ventilation is also~     going to be recorded for all the patients included.~      The study hypothesis is that applying a protocolized early mobilization strategy increases~     the number of ventilator free-days during the 28 days after intubation in ICU patients.~   "
41013|NCT02520180|"~     Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm,~     non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a~     real world, all comers study.~   "
41014|NCT02520167|"~     This study will pilot and assess feasibility of a prenatal intervention for obese pregnant~     women based on the Diabetes Prevention Program (DPP). Intervention group participants will~     meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a~     DPP-based curriculum and receive breastfeeding education. Control group participants will~     receive usual prenatal care. Outcomes include reach and dose of the intervention,~     gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6~     weeks postpartum.~   "
41015|NCT02520154|"~     The goal of this clinical research study is to learn about the effects of pembrolizumab on~     ovarian cancer. Researchers want to find out how the disease responds to therapy with~     pembrolizumab.~   "
41016|NCT02520141|"~     The goal of this clinical research study is to learn if ramucirumab can help to control~     biliary cancer. The safety of this drug will also be studied.~   "
41017|NCT02520128|"~     IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of~     Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary~     bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical~     outcomes.~   "
41018|NCT02520115|"~     This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum~     samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian~     cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may~     help understand the use of folate receptor induction as a clinical tool in initial~     diagnosis, surveillance, and recurrence.~   "
41019|NCT02520102|"~     Primary Objective:~      Measure the proportion of patients who develop binding and neutralizing antibodies in the~     blood after treatment with sargramostim following induction/reinduction chemotherapy.~      Secondary Objectives:~        -  Assess the time after treatment at which the antibodies develop and the level of~          antibodies is measured after the first dose.~        -  Measure the levels of immunoglobulin protein.~        -  Assess the impact of any immune response on safety and the duration of low white blood~          cell count.~   "
41020|NCT02520089|"~     Patients with humeral shaft pseudoarthrosis is going to be treated with a standard protocol~     with a locking compression plate and bone autograft, and other group of patients treated~     with platelet rich plasma.~      Posteriorly all the patients it will evaluated radiographically and with functional scales~     for a period of one year.~   "
41021|NCT02520076|"~     Islet transplantation is a relatively new procedure used in people with difficult to control~     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by~     the next of kin of a person who is brain dead. After the cells are prepared, the islets are~     transplanted into the recipient's liver and produce insulin. Patients who receive an islet~     transplant take medication that suppresses their immune system and prevent rejection of the~     islet tissue.~      The investigators have also learned that there is general inflammation at the time of the~     transplant that is not fully controlled with our standard medications. The investigators~     believe this inflammation may cause some islet cell death around the time of transplant. Due~     to this islet death around the time of transplant, most recipients need 2 or 3 separate~     transplant procedures.~      The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to~     decrease the amount of cell death caused by general inflammation. In this study, the~     investigators hope to decrease the need for more than one transplant procedure by~     controlling inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast~     NP).~      Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage~     during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors.~     There have been studies in Islet Transplant in monkeys using this medication and it has~     shown to protect the islets from inflammation.~      This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care~     medications used in Islet Transplant.~   "
41337|NCT02515916|"~     The purpose of this study is assess the effects of oncology treatment on ovarian reserve and~     also to better understand the experiences, thoughts and feelings of women scheduled to~     undergo chemotherapy/radiotherapy and seeking fertility preservation at Weill Cornell~     Medical College (WCMC).~   "
41023|NCT02520050|"~     The American Diabetes Association (ADA), among other medical societies, is strongly~     recommending medical nutrition therapy (MNT) for prevention and management of type 2~     diabetes. However, the ADA recognized that there is no one size fits all diet and thus~     recommends that MNT should be conducted through a consultation with registered dietitians~     (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an~     integral part of the MNT, lowers postprandial blood glucose levels. Through our experience~     from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying~     MNT within a structured dietary intervention protocol has the best impact on blood glucose~     values and body weight. Meanwhile, the frequent use of health coaching during dietary~     intervention proved to be effective in managing diabetes and inducing weight loss. However,~     no study compared those three intervention methods in a randomized clinical study.~      The aim of this study is to evaluate the effect of different models of conducting medical~     nutrition therapy on the glycemic control in patients with type 2 diabetes.~   "
41024|NCT02520037|"~     Fluids are generally administered to patients in order to improve circulation. However,~     fluids do not always improve circulation and fluids have side effects. Unfortunately, it is~     difficult to predict whether fluid administration improves the circulation, i.e. it is~     difficult to predict fluid responsiveness The overall aim of this observational study is to~     investigate if analysis of spontaneously occuring extra systoles can give the answer: The~     second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has~     experienced the compensatory pause, i.e. this beat is associated with increased filling time~     and in turn associated with increased filling. As such, the post ectopic beat shows how the~     heart responds to increased filling. Therefore, the hypothesis of this study is that the~     hemodynamic response to the increased filling at the post ectopic beat (compared with sinus~     beats) can predict fluid responsiveness~   "
41025|NCT02520024|"~     This project proposed to demonstrate the effectiveness, costs, and benefits to participation~     and community living self-directed care programming within a financially sustainable~     Medicaid managed care environment. The study examined outcomes associated with the~     implementation of a novel self-directed care (SDC) approach being implemented in Delaware~     County, Pennsylvania in which consumers were able to access a set amount of renewable funds~     per year and direct how they were spent, both to purchase the types and amounts of~     rehabilitation and treatment services they desire (and from whom they choose) and to~     purchase a broad-range of individualized resources and services that are generally outside~     of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of~     bills).~   "
41026|NCT02520011|"~     The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete~     Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with~     demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.~   "
41027|NCT02519998|"~     The purpose of this study is to prospectively collect a comprehensive, multi-modality set of~     diagnostics on patients who have had a concussion, repeating some of these tests serially~     over time, so that the investigators may then in the future perform retrospective data~     mining to determine if there were a biomarker or risk calculator that could be used to guide~     return-to-play and other medical decisions.~   "
41028|NCT02519985|"~     The purpose of this study is to evaluate the repeatability and reproducibility of corneal~     (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment~     measurements using the ArcScan Insight 100 very high-frequency digital ultrasound~     arc-scanner.~   "
41029|NCT02519972|"~     Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung~     cancer. Relatives with family history of lung cancer are at increased risk of lung cancer~     compared to those without a family history in pooled analysis. A prospective trial using~     LDCT of lung to screen the relatives with family history of lung cancer is needed.~   "
41030|NCT02519959|"~     In head and neck cancer, areas of tumours with low oxygen supply (called tumour hypoxia)~     harbour cells that are resistant to radiation and are prone to metastasize. Modern~     radiotherapy techniques are precise enough to deliver radiation to these small areas and~     could be used to target these areas to receive higher doses of radiation than the rest of~     the tumour to overcome resistance. Hypoxia can be seen in the body using special imaging~     such as [F-18]-FAZA-PET ([F-18]-Fluoroazomycin arabinoside positron emission tomography) but~     it has not been tested as a method for creating radiation treatment targets. As part of~     regular pathology tumour tissue is sliced extremely thinly (<1/100th of a millimeter) and~     stained so that individual cells can be seen under a microscope. Immunohistochemistry (IHC)~     is a special type of stain that can specifically highlight hypoxic areas. This method is~     considered the most accurate way to inspect for the presence of hypoxia. There is not a~     specific staining target for hypoxia ordinarily, but when patients ingest a substance called~     pimonidazole-HCl it builds up specifically in hypoxic areas and can be targeted for IHC~     staining. In this study participants with oral tongue cancer will have a [F-18]-FAZA-PET~     scan and take a single dose of oral pimonidazole-HCl before having surgery to remove their~     cancer. The whole tumour will be used to create microscope slides using very thin slices of~     the tumour. The slices will be stained using IHC to show where the pimonidazole has built~     up. Digital scans of the slides will be made using a laser scanner. The hypoxia seen on~     their FAZA-PET scan will be matched with hypoxia on the electronic slides to see if the~     FAZA truly shows where hypoxia is in tumours and if it could be used as a way to plan~     radiation treatments to deliver more radiation to just those areas.~   "
41031|NCT02519946|"~     Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their~     long-term outcomes and survival. Currently, no effective cardiovascular preventative care is~     provided for this pediatric population, in part, due to the fact that clinic-based programs~     are not easily accessible to children and their families. However, tele-health has been show~     to improve medical outcomes by making care more accessible to these patients. This study~     aims to meet the urgent need for an effective and sustainable delivery of preventative care~     to pediatric heart transplant patients using a diet and exercise intervention program~     delivered live over the internet direct to these patients' homes.~   "
41032|NCT02519933|"~     A well-functioning vascular access is essential for effective hemodialysis. The native~     arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis~     and infection risks compared to either synthetic arteriovenous grafts or central venous~     catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic~     arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no~     suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the~     antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise~     proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also~     associates with severe arm swelling and pain. Thus, the investigators introduced a novel~     modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term~     hemodialysis patients. To confirm its efficacy, a prospective clinical study would be~     carried out.~   "
41034|NCT02519907|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might~     be elicited or worsened by a range of physical factors (e.g. changes in the weather or~     pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well~     known that most treatments available for PLP today, such as pharmacological, surgical,~     anaesthetic, psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical~     reorganization and alleviation of phantom limb pain has been observed in amputees following~     intense use of a hand prosthesis. However, there is no consistent knowledge on which type of~     peripheral sensory feedback may be effective in affecting the cortical plasticity or on how~     to best apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
41035|NCT02519894|"~     Introduction :~      Due to Chronic kidney disease is a public health problem, which is important increased in~     both developed and developing countries . And sodium intake restriction was related to the~     reduction of blood pressure and urine protein which is one of the important risk factor in~     chronic kidney disease. One of the problem in sodium restriction failure in Thai population~     with CKD nowadays is lack of knowledge and problem unawareness.~      The study hypothesis :~      Intense knowledge about sodium reduction and immediate feedback of the sodium intake could~     be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also~     GFR reduction rate~      Objectives :~      To compare the effect of dietary salt restriction on glomerular filtration rate (GFR)~     between CKD patients receiving strict controlled combined with immediate individual feedback~     (DISC Progrram) and those receiving standard education.~      Study design :~      Multicenter, open labeled, parallel, randomized controlled trial~      Sample size : 600~      Primary outcome : GFR reduction (CKD-EPI)~      Secondary outcome :~        -  Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)~        -  Blood pressure difference~        -  Proportions of patients with BP reached the target (130/80 mmHg)~        -  Number of anti-hypertensive drugs use to achieve BP target~        -  Urine albumin/creatinine ratio~        -  Major Adverse Cardiac Events (MACE)~        -  Cardio-ankle vascular index (CAVI)~        -  ankle-brachial index (ABI)~      Documentary Proof of Ethical Clearance :~      This project has been reviewed and approved by the Comittee on Human Rights Related to~     Research Involving Human Subjects , based on the declaration of Helsinki~   "
41036|NCT02519881|"~     This study was designed to evaluate the efficacy and safety of a modified microfracture~     using collagen, and to compare them with those of a simple microfracture in patients with~     cartilage defects in their ankles.~   "
41037|NCT02519868|"~     High blood pressure, also referred to as hypertension, affects about 65 million people in~     the United States alone. Approximately 25 percent of people with hypertension cannot control~     their high blood pressure, despite the use of multiple medications. Recently, new evidence~     has demonstrated that the carotid body (CB) plays a role in essential refractory~     hypertension, possibly due to a deregulated, enhanced activity of this organ. Animal studies~     showed that CB de-afferentiation, through carotid sinus nerve denervation, leads to a~     long-term stable drop in blood pressure in spontaneously hypertensive rats.~     De-afferentiation may be performed either by injecting local anesthetics or by electrical~     stimulation. Both techniques are daily used in the operating theater to anesthetize nerves~     for a wide range of surgical procedures. We hypothesize that blocking CB with local~     anesthetics will result in a drop of the blood pressure in refractory hypertensive patients.~     We also want to test the idea that stimulating the CB with an electrical current will~     mislead the CB and will also result in a drop of the blood pressure.~   "
41038|NCT02519855|"~     The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211)~     administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine~     (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the~     noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella~     zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of~     geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the~     noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza~     virus strain-specific GMT antibody responses.~   "
41039|NCT02519842|"~     The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517)~     plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea~     and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s)~     associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s)~     not previously tolerated due to vomiting. The primary hypothesis is that a single dose of~     fosaprepitant in combination with ondansetron provides superior control of CINV compared to~     ondansetron alone as measured by the percentage of participants with a Complete Response (no~     vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120~     hours) following initiation of emetogneic chemotherapy in Cycle 1.~   "
41040|NCT02519829|"~     Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl~     closure of fascial and dermal layers with dermabond and tegaderm covering versus standard~     vicryl closure of fascia layer and staple closure for skin. Short term wound complications,~     pain and patient and surgeon-rated cosmetic scar appearance will be measured. The~     investigators will also measure operating room time and costs associated with dressing~     changes and wound-related procedures (e.g. staple removal).~   "
41041|NCT02519816|"~     Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with~     steroid-refractory or dependent chronic graft vs host disease.~      Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24~     weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell~     depletion and Regulatory T-cell Expansion)~   "
41177|NCT02518035|"~     Effort to reduce post-surgical scar is especially important for microtia patients. Even the~     scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear~     auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will~     accompanies the child for many years.The main objective aim of this study is to examine~     whether post-operative use of silicone gel can improve scar formation for microtia~     reconstruction scars.~   "
41042|NCT02519803|"~     Title: A Prospective Household observational cohort study of Influenza, Respiratory~     Syncytial virus and other respiratory pathogens community burden and Transmission dynamics~     in South Africa (The PHIRST Study) This study will improve understanding of the community~     burden of influenza, RSV, pertussis, tuberculosis and pneumococcal infection in South~     Africa. It will also provide data on the carriage prevalence of meningococcus and~     diphtheria. The data generated from this study will also provide important information on~     the transmission dynamics of influenza, RSV, pertussis and pneumococcus in the community~     allowing to better strategize interventions (including targeted vaccination strategies) and~     evaluate their potential impact. Moreover, there is an absence of prospective data on~     tuberculosis infection from high tuberculosis burden countries. The data generated will both~     inform modelling of transmission, sample size for prevention studies and surveillance~     assessing the impact of the National Tuberculosis Control Program.~   "
41043|NCT02519790|"~     The purpose of this study is to explore the way the antidepressant concentration (amount of~     medication) in the blood changes due to the physiological changes in the body (i.e., changes~     in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of~     genetic factors on the degree of these changes. Changes in antidepressant concentration are~     important to monitor, as decreases in antidepressant concentration may lead to less than~     therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of~     depressive episodes. Increases in antidepressant concentration have the potential to lead to~     increased side effects. The study team is hoping to better understand the course of these~     changes across pregnancy and postpartum and how an individual's genetic makeup impacts these~     changes with the goal of developing guidelines to optimize antidepressant treatment of~     pregnant women.~   "
41044|NCT02519777|"~     People infected with HIV often have cognitive dysfunction even if they are on antiretroviral~     therapy (ART) and have undetectable viral loads. The purpose of this study is to evaluate if~     the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV]~     medications) to participants' existing ART regimens will improve participants'~     neurocognitive performance.~   "
41045|NCT02519764|"~     The main objective of this study is to evaluate the impact of a hydration protocol at~     thirst compared to other not at thirst hydration protocols on the changes in serum sodium~     in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.~   "
41046|NCT02519751|"~     Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of~     muscle mass. The method uses a dose of deuterium-labelled creatine to determine total~     skeletal muscle mass via estimation of total body creatine pool size.The aim of this study~     is to compare estimates of total body skeletal muscle mass by D3-creatine dilution method~     and whole body Magnetic Resonance Imaging (MRI) in an athletic population.~   "
41047|NCT02519738|"~     Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common~     problem seen in the pediatric surgery population. There is no standard treatment that has~     been identified in clinical practice to treat granulation tissue effectively. Clinicians~     prescribe treatments of varying nature to help treat this condition. By conducting this~     study, the investigators hope to identify if there is any difference in the treatment groups~     and if there is any superiority for one treatment over the other. The three arms in the~     study are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion.~     Treatments will continue over a period of three weeks, and the progress will be followed~     using surveys and photographs.~   "
41048|NCT02519725|"~     The purpose of this study is to assess the influence of an ICU diary implemented during the~     ICU stay on the psychological well-being of patients and families after ICU discharge.~   "
41049|NCT02519712|"~     The purpose of this study is to test a method of bone marrow transplantation that results in~     only temporary donor immune function. In other words, the donor immune cells are given in a~     way that will allow them to attack leukemia briefly before being destroyed by their own~     immune system, or rejected. The investigators want to test whether temporary donor immune~     function is enough to improve the odds of achieving a remission without exposing the patient~     to the toxicities of a full bone marrow transplant. To do this, the investigators will use~     standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be~     a family member who is haploidentically, or half matched, to the patient such as a child or~     sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from~     rejecting the donor stem cells. The investigators will then follow the patient to see how~     long the donor stem cells stay in them. The study will test whether this process is feasible~     and can result in improved chances of obtaining a remission.~   "
41050|NCT02519699|"~     The optimal levels of mean arterial pressure that must be achieved in septic shock are~     subject of debate. Studies tried to correlate blood pressure increase in patients with~     septic shock with microcirculation. However, there are few studies that specifically~     assessed septic shock patients with previous arterial hypertension. The main objective of~     this study is to evaluate the effect of increased blood pressure level in the~     microcirculation of these patients and compare them with patients without arterial~     hypertension.~   "
41051|NCT02519686|"~     The purpose of this study is to determine if the trendelenberg (TD) position (position in~     procedures that involves placing the patient at an angle so that their head is lower than~     their feet on the procedure bed) in select patients undergoing colonoscopy is superior than~     the left lateral (LL) position (patient laying on their side, traditionally used for~     colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the~     left colon, and decreasing the difficulty of the procedure.~   "
41061|NCT02519556|"~     Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or~     relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The~     hypothesis that an appropriate early stimulation of the intestinal flora contributes to the~     establishment of the immune system balance has led to the use of probiotics in the~     prevention and treatment of AD in several clinical and experimental studies.~      Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture~     of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD~     (scoring atopic dermatitis) and to evaluate the effects of this medication in the following~     laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation~     composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor~     necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth~     factor beta [TGF - β]).~   "
41052|NCT02519673|"~     In refractive surgery, stromal ablation depth is fundamental because it determines the~     thickness of the residual posterior wall. The posterior wall is an essential element that~     guarantees the refractive stability and the long term prevention of corneal ectasia after~     corneal refractive surgery. A minimum thickness of more or less 300 microns is universally~     accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.~      With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a~     new treatment option called wavefront optimized is offered for myopia, astigmatism and~     hyperopia. The ablation profile has been developed to save stromal tissue consumption and to~     favor the quality of vision, by optimizing connections between the optical zone and the~     transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the~     depth of ablation may be defined by differential ultrasonic pachymetry or by topographical~     analysis pre and postoperatively. The latter is currently the method of reference to assess~     the corneal thickness.~   "
41053|NCT02519660|"~     Needle-related procedures are among the most common sources of pain and distress for~     children in the health care setting. More than 50% of children reported pain during these~     procedures. The necessity for pain management during these procedures is well established.~     Topical anesthesia has been shown to be effective in managing needle-related pain. Eutectic~     mixture of local anaesthetic (EMLA) cream is the topical anesthetic most used. The~     application of this mixture of lidocaine and prilocaine reduce pain during needle procedures~     in children. To be effective EMLA cream must be applied for at least 60 minutes before~     needle procedure. This is the major limitation for its use in emergency settings.~      Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine~     and tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its~     application. Only one randomized controlled trial compared the two topical anaesthetics in~     children during venipuncture and showed that Ralydan patch led to superior analgesia than~     EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes~     before needle procedure. No differences were found in success rate of the procedure and vein~     visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after~     60 minutes from application.~      To the best of the investigators' knowledge there is no published study that compared needle~     procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine~     patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.~      The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum~     analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the~     first attempt and pain relief in children.~   "
41054|NCT02519647|"~     Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite~     is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the~     efficacy of a new designed bougie for intubation in patients with simulated difficult~     airways.~   "
41055|NCT02519634|"~     Shock wave lithotripsy (SWL) is recommended for kidney stones < 20 mm. However, the stone~     clearance of lower pole calculi after SWL is limited, thus leading to an extended indication~     for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many~     centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is~     postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments.~     However, this issue remains controversial.~      On the other hand, improvements in endoscopy technology have made retrograde stone removal~     more attractive. This has led to an increasing use of RIRS as a primary treatment although~     it is recommended only as 2nd-line option by current guidelines. However, the treatment of~     symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.~      The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the~     treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.~   "
41056|NCT02519621|"~     This study is designed to assess the efficacy and economics of two NPWT branded devices of~     wound healing outcomes. It is also designed to assess the effectiveness of negative pressure~     and negative pressure with continuous irrigation on multiple parameters of wound healing. It~     is a single-center, open-label, active controlled, parallel-group trial that aims to~     determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic~     foot ulcers. Specifically, eligible participants will be randomized to receive either PRO~     negative press therapy with simultaneous irrigation; or PRO negative pressure therapy~     without irrigation; or KCI Ulta negative pressure therapy.~   "
41057|NCT02519608|"~     This is an investigator-initiated, prospective, single-centre, randomised, phase II,~     open-label study, testing the superiority of ticagrelor, as compared to clopidogrel, in~     modulating on-P2Y12 treatment platelet reactivity, endothelial dysfunction and inflammation~     in chronic obstructive pulmonary disease (COPD) patients receiving scheduled percutaneous~     coronary intervention (PCI) for stable coronary artery disease. Subjects that meet the~     inclusion criteria and have provided informed consent will be randomly assigned in a 1:1~     fashion to one of the two dual antiplatelet therapy (DAPT) regimen: aspirin + clopidogrel~     (standard of care) vs. aspirin + ticagrelor (experimental arm).~      DAPT with aspirin and clopidogrel for at least 6 months (preferably 12 months) is the~     current gold-standard for patients receiving PCI and drug eluting stent implantation for~     SCAD. No data supports a different strategy and/or approach in COPD patients undergoing PCI.~     Ticagrelor, a new P2Y12 inhibitor, showed a significantly higher platelet inhibition as~     compared to clopidogrel. Recently, ticagrelor administration has been associated with a~     positive effect on endothelial function and a modulation of proinflammatory signalling.~     These actions are mediated by a significant influence of adenosine uptake. Higher platelet~     reactivity, chronic inflammatory response, heightened endothelial dysfunction characterized~     COPD patients with concomitant coronary artery disease (CAD). The investigators speculated~     that COPD patients undergoing PCI for stable CAD (SCAD) had a risk profile similar to that~     of acute coronary syndromes (ACS) patients. Accordingly, COPD patients undergoing PCI for~     SCAD may obtain a stronger benefit by ticagrelor as compared to clopidogrel. The aim of this~     study is to evaluate whether ticagrelor, is superior to clopidogrel, in reducing endothelial~     dysfunction , platelet reactivity (PR) and inflammation profile of patients with stable CAD~     and COPD. Ticagrelor will be administered according PLATO trial and international guidelines~     (180 mg as loading dose, 90 mg x 2 daily as maintenance dose). As suggested by international~     guidelines, the control group will be patients with current gold standard treatment for SCAD~     treated with PCI (aspirin + clopidogrel 75 mg daily). The evaluation of endothelial~     dysfunction, PR and inflammation profile will be repeated after 30 days and will be compared~     to baseline values.~   "
41058|NCT02519595|"~     There is a wide variation of published IV ketamine dosing regimens used for procedural~     sedation in children in the Emergency Department (ED). The purpose of the study was to~     compare the efficacy, duration of sedation and adverse events between the three commonly~     administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional~     administration method of 30-60 second infusion for ED sedation in children.~   "
41059|NCT02519582|"~     Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients~     who are progressive with metachronous or synchronous metastases of colorectal cancer among~     the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All~     patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or~     unacceptable toxicity or discontinuation of study for other reasons.~   "
41060|NCT02519569|"~     A considerable proportion of bereaved individuals experience chronic and disabling grief~     (so-called complicated or prolonged grief). Complicated grief is associated with severe~     mental and physical health problems as well as impaired social and occupational functioning.~     Interventions based on cognitive-behavioral therapy and applied via the internet have shown~     to be efficacious for this condition, but have not yet been adapted and evaluated in Norway.~     The aim of the current study is to adapt an internet-based cognitive-behavioral intervention~     for complicated grief and evaluate its effectiveness as a pilot study.~   "
41062|NCT02519543|"~     In a previous study by Dr. Calkin, the principal investigator of this study, persons with~     bipolar disorder and either type II diabetes or insulin resistance were found to experience~     more severe symptoms of bipolar illness and a lower response to treatment, compared to~     persons with bipolar disorder who did not have type II diabetes or insulin resistance. To~     further explore these findings, the investigators have developed this study to see if adding~     metformin, a drug used to improve the body's use of insulin, may also help improve the~     symptoms of bipolar illness.~   "
41063|NCT02519530|"~     Investigators are carrying out a study to assess the immediate and long-term effects of a~     positive youth development program (the Teen Outreach Program) on high school youth in~     Florida. This study will answer the following questions: What is the impact of the Teen~     Outreach Program on sexual activity and positive youth development at the end of the program~     and 10 months after the program?~   "
41064|NCT02519517|"~     Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy.~     Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV)~     and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35~     mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min~     post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH~     >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures~     analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value~     < 0.05 is considered statistically significant.~   "
41065|NCT02519504|"~     The purpose of this study is to learn about Duarte galactosemia (DG). This study will~     examine the possible effects of Duarte galactosemia (DG) in children, and determine whether~     dietary exposure to milk in infancy or early childhood is associated with developmental~     outcomes of school-age children with Duarte galactosemia (DG).~   "
41066|NCT02519491|"~     Accessing the arteries of the heart through the blood vessels of the wrist is becoming~     increasingly popular. By obtaining access via the artery in the arm as opposed to the groin,~     there is less risk of complications and improved patient satisfaction. However, using the~     wrist can cause blockage of the artery after the procedure. If there is too little blood~     flow from a second artery that supplies the hand, this could result in significant injury.~     Therefore, it is important to test these blood vessels in the wrist prior to having this~     procedure. The best way to evaluate these arteries involves the use of ultrasounds but this~     takes a long time and is expensive. Therefore, the artery is usually evaluated with a~     clinical test known as the modified Allen's test, which relies on the doctor watching the~     flushing of the hand during compression of the artery. Currently smart phones with cameras~     are able to assess blood flow by passing light through the skin and watching differences in~     brightness. This may be a better way to assess the arteries in the hand as it is less~     subjective than simply watching the flushing of the hand. This study aims to assess the~     ability of an iPhone application in determining whether there is sufficient blood flow~     through the arteries of the wrist and comparing it to the clinical test commonly used.~   "
41067|NCT02519478|"~     The purpose of the study is to determine the effectiveness of the helmet-less tackling~     training (the HuTT Technique) intervention to reduce head impacts in high school football~     players and to gain an understanding of the neurocognitive effects of repetitive head~     impacts in football. The investigators hypothesis is that the HuTT Technique will result in~     a reduced frequency and magnitude of helmet impacts than the control group measured by a~     head impact measurement system. Also, the investigators hypothesize the HuTT Technique group~     will demonstrate less changes in neurocognitive scores in the mid and post season~     evaluations compared to the control group. Head impacts will be measured using the SIM-G~     impact monitor made by Triax Technology. The SIM-G impact monitor measures the location,~     magnitude, and direction of every head impact in real time and is stored on a protected~     cloud-based system. The sensor is worn by each athlete in a headband or skullcap.~     Neurocognitive function will be measured using the Immediate Post-concussion Assessment and~     Cognitive Testing (ImPACT) test. The test is used as a tool to determine baseline~     neurocognitive function and is used in comparison if an athlete was to be injured to ensure~     he/she returns to baseline. ImPACT measures memory (verbal, visual, working), processing~     speed and reaction time using a variety of tests. Subjects will be recruited from local high~     school football teams and will include freshman, sophomores and juniors. Since the study is~     expected to run for 2 years, seniors will not be eligible for participation. The target is~     to recruit at least 150 total subjects. All subjects will be equipped with a new helmet that~     is fitted to their head and a headband that will be used to hold the head impact telemetry~     sensor. In addition, all subjects will take an ImPACT test preseason, midseason and~     postseason. At the conclusion of each season, all of the impacts from the SIM-G impact~     monitor system and ImPACT test scores will be analyzed. The relevant outcome measures to be~     analyzed include head impact frequency, location, magnitude, symptom scores, memory, visual~     motor speed and reaction time composite scores. Statistical analysis will be used to~     determine if the HuTT intervention minimized head impacts and neurocognitive decline~     compared to the control group.~   "
41068|NCT02519465|"~     The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal~     interface have been employed in an attempt to relieve respiratory distress and optimize the~     deposition of drugs by inhalation.~      Some studies report the effects of NIV association with fogging in healthy subjects,~     asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist~     interface and therapy are scarce and most are found in vitro and animal models. The~     objective of this study is to evaluate the deposition of the aerosol scintigraphy using the~     high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.~   "
41069|NCT02519452|"~     The purpose of the study is to evaluate the safety, pharmacokinetics and antitumor activity~     of subcutaneous (SC) or intravenous (IV) delivery of daratumumab to participants with~     relapsed or refractory multiple myeloma.~   "
41070|NCT02519439|"~     A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult~     patients with drug-resistant partial-onset seizures~   "
41071|NCT02519426|"~     The study evaluates and validates a new classification proposed by Juodzbalys and Daugela in~     2013 predicting the complexity of impacted mandibular third molars surgical extraction,~     comparing it with other two, scientifically approved (Pell and Gregory, Winter)~     classifications.~   "
41072|NCT02519413|"~     The primary objective of the study is to retrospectively investigate changes in lymphocyte~     counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on~     Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes~     in lymphocyte subtypes other than CD4+ and CD8+ T cells.~   "
41073|NCT02519400|"~     A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline,~     25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and~     cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma~     concentrations of amitriptyline, nortriptyline, and their metabolites. Various~     pharmacodynamic markers related to the adverse event of amitriptyline will be measured~     serially during the study.~   "
41076|NCT02519361|"~     Aging cause specific changes in the immune system. Processes like immunoessence and~     inflammaging offend the functioning of the immune cells and expose the elderly patient to~     infections that can lead to morbidity and death.~      Protein translation regulation offers a strategic advantage to the immune cells, because it~     enables rapid activation or termination of synthesis of specific proteins, required for~     inflammation or its resolution. Translation initiation depends on recruitment of eukaryotic~     initiation factor eIF4F complex.~      The aim of the current study is to investigate the involvement of the translation initiation~     factors (eIF4E and eIF4G) in the process of recovery from acute infection in elderly patient~     admitted to the internal department with an acute infection.~   "
41077|NCT02519348|"~     This is a multicenter, open-label, stratified, randomized study to evaluate the safety,~     tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736~     (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab~     monotherapy in subjects with unresectable hepatocellular carcinoma~   "
41078|NCT02519335|"~     Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow~     the surgeon to perform heart operations. However, these processes can cause injury to the~     heart which may worsen post-operative outcomes. In fact, the effects of these injuries may~     continue after surgery, and lead to a long-term decrease in heart function. Neonates and~     young infants are at particular risk for this occurrence.~      While much research has been done in adults looking for medicines that might protect the~     heart during surgery, few studies have been conducted in neonates and young infants. The~     investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric~     cancer patients, in the hope that it may lessen cardiac injury during and after congenital~     heart surgery, and thereby improve outcomes in the neonatal and young infant population.~      In order to accomplish this, the investigators must first determine how Dexrazoxane can be~     safely administered to young children with congenital heart disease. Therefore, the~     investigators are performing a pilot study of 12 children to assess:~        1. how Dexrazoxane at 3 different doses is metabolized in the body of a child age 0-6~          months during and after congenital heart surgery, and~        2. the safety of Dexrazoxane use in the neonatal and young infant population undergoing~          cardiac surgery.~   "
41079|NCT02519322|"~     The goal of this clinical research study is to learn if giving nivolumab alone or in~     combination with ipilimumab before and after surgery can help to control metastatic~     melanoma. The safety of these drugs will also be studied.~   "
41080|NCT02519309|"~     The primary purpose of this research is to demonstrate the therapeutic effects on diabetes,~     pre-diabetes and metabolic syndrome of implementing a well-formulated low carbohydrate~     lifestyle program.~   "
41081|NCT02519296|"~     In this article, the investigators report the design and protocol of a functional magnetic~     resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged~     Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10~     diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited~     consisting of age-appropriate same sex veterans who have participated in international~     missions similar to the patient group~   "
41082|NCT02519283|"~     Approximately 20-30% of patients presenting with acute heart failure are discharged from the~     ED. Compared to patients discharged from the hospital, they more frequently return to the ED~     and hospital for further management. While inpatient discharges are often enrolled in~     transitions programs and have their care tailored to evidence-based recommendations, ED~     discharges do not. The investigators propose to evaluate current standard ED discharge to an~     ED-based intervention which will transition patients to outpatient follow-up on~     guideline-recommended therapy.~   "
41083|NCT02519270|"~     A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects~     with Refractory Non-Hodgkin Lymphoma (NHL)~   "
41084|NCT02519257|"~     Atherosclerosis is an inflammatory process in which immune mechanisms interact with~     metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees~     and is known as the main cause of coronary artery disease (CAD). Recently, there are more~     and more studies highlighted the potential importance of adipose tissue in relation to~     inflammation effects on CAD pathogenesis. However, it remains unclear whether Thy-1,~     adiponectin or any other inflammatory mediators in mediastinal adipose tissue contribute to~     CAD. In this study, we aim to analyze the expression of inflammatory mediators' expression~     via in vitro assay (3T3-L1 cell culture) and in vivo assay (human adipose tissues).~   "
41085|NCT02519244|"~     The purpose of this study is to investigate whether a wearable robotic exoskeleton can help~     people with multiple sclerosis (MS) to walk again.~   "
41086|NCT02519231|"~     Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper~     IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory~     medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did~     not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available~     NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot~     trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or~     spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7~     days of menstruation for three consecutive cycles, and then observed for one cycle without~     treatment.~   "
41087|NCT02519218|"~     The purpose of this study is to collect outcomes data in patients implanted with the Ellipse~     IM HTO Nail System.~   "
41088|NCT02519205|"~     The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8~     vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).~   "
41089|NCT02519192|"~     This study hopes to determine if a negative pressure dressing is superior to a traditional~     dressing for speeding fistula closure after laparotomy. This study has a broad variety of~     implications. Patient safety is a paramount concern: Investigators hope to identify a~     superior method of wound management which minimizes risk for skin breakdown, sepsis, and~     morbidity. In addition, patient satisfaction would be improved with a method for faster~     wound healing. Finally,implications exist in the realm of a cost-benefit analysis, for~     example, although the VAC method is more costly, it may save money if it speeds healing and~     prevents the need for reoperation. Alternatively, if the VAC method is not shown to be~     beneficial, physicians can avoid using a more costly device with no proven benefit.~   "
41090|NCT02519179|"~     The objective this research is to conduct a within-subject, experimental study that will~     describe mothers' feeding practices during typical bottle-feeding conditions and will~     examine whether removal of visual cues related to the amount of milk/formula in the bottle~     will alter these feeding practices. The investigators hypothesize that mothers will show~     higher levels of infant-directed feeding practices and lower levels of mother-directed~     feeding practices when using opaque, weighted bottles compared to when using standard, clear~     bottles. The investigators also hypothesize that infants will consume less breast milk or~     formula when fed from opaque, weighted bottles compared to when fed from standard, clear~     bottles.~   "
41091|NCT02519166|"~     In this prospective observational study, the investigators tried assess the presence of~     biofilm on chronic wound samples coming from a large cohort study of patients, whilst~     cross-referencing the clinical, bacteriological and wound care observations.~   "
41092|NCT02519153|"~     Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is~     estimated to be between 5% and 12% all over the world with increased incidence in male~     rather than female (2:1) respectively . Ureteral stones account for 20% from all urinary~     tract stones, more than 70% of the ureteral stones found in the lower third of the ureter .~     The incidence of urinary stones has been increasing day by day. Medical expulsive therapy~     (MET) of ureteral stones is the investigators' concern in this study. Stone location, size,~     number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors~     affecting passage of the ureteral stones. So, MET is based on mechanism that stone passage~     is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure~     proximal to the stone and decreasing exciting edema . There are many oral medication could~     be used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin~     synthesis inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers~     and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as~     expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes~     (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the~     ureter. A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and~     tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human~     ureteral smooth muscle via cGMP-mediated pathways.~   "
41093|NCT02519140|"~     This is a study to determine how the viscosity (thickness) of an FDA approved gel made by~     Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of~     endoscopic surgery performed for localised cancer - can be performed when the gel is~     injected submucosally. The lifting characteristics of the gel will be assessed by height and~     diameter and ease with which the subsequent EMR dissection can be performed. These~     characteristics would be assessed on excised human stomachs and colon, which are harvested~     during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.~   "
41094|NCT02519127|"~     This study is testing the effectiveness of a dietary intervention by means of measuring the~     change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring~     the kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge~     before and after a 6-week dietary intervention. The challenges will be applied to~     investigate whether the kinetic response is a better measure for health and wellbeing when~     compared to fasting (baseline) levels. In addition, several measures that reflect~     perceivable benefits like mood, quality of life, sleep quality, cognitive and physical~     performance will be assessed in a first exploratory attempt to link (changes in) PF to~     consumer perceivable benefits.~      Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6~     weeks. Before and after the intervention several measurements will take place. The low~     glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and~     nuts, and low in glycemic carbohydrates. All these dietary factors have been shown to~     improve glycemic control and/or to reduce metabolic syndrome risk factors.~   "
41095|NCT02519114|"~     The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with~     post-transplant cyclophosphamide will improve progression free survival in poor risk~     multiple myeloma patients.~   "
41096|NCT02519101|"~     Continuous noninvasive blood pressure monitoring may help to avoid intraoperative~     Hypotension or Hypertension~   "
41097|NCT02519088|"~     The study evaluates the patient related risk and predictive factors concerning perioperative~     homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert~     max-certified orthopedic hospital in Germany.~      A patient oriented preoperative decision-making algorithm (a personalised Patient Blood~     Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.~      The aim is to increase the patient safety by using the pPBM App and to reach a more~     efficient management of resources.~   "
41098|NCT02519075|"~     Prospective exploratory study specifically investigating the diagnostic and predictive role~     of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and~     candidate to TARE. A minimum number of 20 patients will be considered for the analysis.~   "
41099|NCT02519062|"~     This is a retrospective study that involves the revision of clinical, instrumental and~     pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with~     surgery with radical intent at our center.~   "
41100|NCT02519049|"~     Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT~     imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to~     pleurodesis.~   "
41101|NCT02519036|"~     This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending doses of IONIS-HTTRx administered intrathecally to adult patients with~     early manifest Huntington's Disease.~   "
41138|NCT02518555|"~     This randomized phase II trial studies how well ibrutinib works when given together with~     vaccine therapies in treating patients without clinical signs or indications that raise the~     possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk~     chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Vaccines, such as~     pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria~     toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an~     effective immune response to kill cancer cells. Giving ibrutinib together with vaccine~     therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic~     lymphoma.~   "
41102|NCT02519023|"~     Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally~     invasive way in which to remove the uterus, which has less scarring and fewer complications.~     However, this procedure, much like its open-surgical counterpart, is often associated with~     significant post-operative pain. To augment this pain there are many different analgesic~     techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP)~     block is one such procedure involving the injection of a local anesthetic into the plane of~     the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet~     different analgesic approach is that of direct injection of local anesthetic into the~     incision by the surgeon during or just after surgical procedures. These two approaches have~     both been proven to decrease post-operative pain in patients for many procedures, but never~     compared to one another.~   "
41103|NCT02519010|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated~     tablets (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma,~     USA).~   "
41104|NCT02518997|"~     Reading to children is believed to be beneficial to cognitive and mental development.This~     study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to~     bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen~     levels. The investigators will follow rates of common preterm health issues while in the~     hospital and time to hospital discharge. Effects of bedside reading on parental stress and~     infant bonding will be measured and compared to usual rates of these indicators to determine~     if reading to babies reduces stress and enhances bonding.~   "
41105|NCT02518984|"~     Given the advances in Atrial Fibrillation (AF) management and the availability of new~     European Society of Cardiology (ESC) guidelines, there is a need for the systematic~     collection of contemporary data regarding the management and treatment of AF in the member~     ESC countries. It is now nearly 10 years since the last European registry of AF management~     was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was~     needed.~   "
41106|NCT02518971|"~     The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence~     of postoperative urinary retention in primary total knee and hip arthroplasty patients.~   "
41107|NCT02518958|"~     This is a dose escalation protocol to determine the feasibility of co-administration of~     RRx-001 and nivolumab. Immune surveillance is an endogenous mechanism to cause remission of~     neoplastic growth. Epigenetic agents like RRx-001 are associated not only with enhanced gene~     transcription and restored expression of silenced genes but also with increased expression~     of pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of~     antigens that promote immune recognition of tumors. It is hypothesized that RRx-001, will~     prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.~   "
41108|NCT02518945|"~     This is a single center, prospective, randomized, double blinded placebo controlled study~     conducted I patients with type 1 diabetes.The aim of this study is to examine the additive~     effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of~     possible improved glycemic control, reduced glycemic variability, reduced insulin dosages,~     additional effects of weight loss and blood pressure reduction.~   "
41109|NCT02518932|"~     To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.~   "
41110|NCT02518919|"~     The role of Adjunct therapies such as Child Life therapy and Music listening during~     Procedural Sedation and Analgesia(PSA) for children during painful procedures has not been~     studied in the Emergency Department (ED). The investigators hypothesize that there will be a~     reduction in sedation medication dosage without change in sedation efficacy by addition of~     music therapy and Child Life to standard sedation protocol in children 3-15 years of age who~     undergo PSA for painful (orthopedic procedures, laceration repair, incision and drainage)~     procedures in a Pediatric emergency Department (PED).~   "
41111|NCT02518906|"~     Specialized treatment of personality disorders (PD) in youth has been neglected for a long~     time, because these disorders were not diagnosed before the age of 18. Since 2013 the age~     threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change~     is also announced for the International Classification of Diseases (ICD)-11. There is broad~     consensus from both scientific evidence and clinical experience that specialized early~     interventions in adolescents with PD are urgently needed.~      In the last decades a number of specialized psychotherapeutic treatment programs have been~     developed. Despite their conceptual differences, many of the treatment models have shown~     significant effects in the treatment of PD in adults. However, the treatment of adolescents~     with PD remains difficult and further enhancement and development of treatments is needed.~      Given the different therapeutic approaches available, the present project aims to go beyond~     the comparison of integral therapeutic models in the classical outcome study design. While~     outcome research is important to build on the evidence of the effectiveness of an~     intervention, it contributes little to its understanding and refinement. The aim of the~     present multi-center project is to compare two therapeutic methods used in routine care:~        -  Adolescent Identity Treatment (AIT)~        -  Dialectic Behavioral Treatment for Adolescents (DBT-A)~      Treatments will be performed at different study centers and compared using the same measures~     of outcome. The main outcome will be psychosocial functioning.~      Additionally, the psychotherapy process will be investigated to explore specific and~     unspecific mechanisms of the therapeutic process, its outcome and mediators.~   "
41112|NCT02518893|"~     The purpose of the study is to describe service members' experiences as participants in~     health research, including their reasons for deciding for or against research participation.~   "
41113|NCT02518880|"~     To understand the cardiovascular reactions of the human body to changing conditions of~     gravity is an important aim of space science. In this context, cardiac output (CO) is a key~     value to estimate the human cardiovascular system.~      The main objective of this experiment is to determine the effects of parabolic flight on~     intravascular volume, and how these changes modulate the complex haemodynamics induced by~     the parabolas.~   "
41178|NCT02518022|"~     The purpose of this study is to show that during and after drinking beer a treatment~     strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia~     without an increase of hypoglycaemic events compared to a treatment strategy according to~     the standard recommendation without insulin Bolus.~   "
41114|NCT02518867|"~     Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment~     of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive~     TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious~     subjects through the intact scalp. The investigators hypothesize that excitatory rTMS~     applied over the motor cortex would increase motor cortex activity and result in an increase~     in the inhibitory input through the corticospinal tract to the spinal cord, thus reducing~     alpha neuron hyperactivity and consequently clinical spasticity. In this study, the~     investigators will apply the stimulation on the legs motor cortex area, which can cover~     supplemental motor area (SMA). Therefore, not only the spasticity, but also the motor~     control of legs both can be modulated by stimulation. Theta burst stimulation is a condition~     of rTMS which was designed by the co-investigator. It has controllable, consistent,~     long-lasting, and powerful effects on motor cortex physiology and behavior. The~     investigators therefore design this protocol using theta burst stimulation on the motor~     cortex of the patients of cerebral palsy. The investigators expect that there would be an~     effect on the reduction of spasticity after rTMS on the brain of children with CP, thus~     improving the motor control of legs.~   "
41115|NCT02518854|"~     Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely~     under-diagnosed in children and adolescents. Obesity and hypertension are two important~     requirements for criteria of MetS. With early detection and early intervention of MetS in~     children and adolescents will enable better care to reduce the heavy burden of health care~     all over the world.~      Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with~     overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to~     reach the following research goals:~      1) To identify biomarkers as risk factors; 2) To characterize that impact of vascular~     assessment in preMetS children; and 3) To examine the relationship among biomarkers,~     vascular assessment parameters, and metabolic phenotypes.~   "
41116|NCT02518841|"~     The investigators will compare Achilles tendon stretching with a new product called a~     ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and~     exercises, in the treatment of chronic plantar fasciopathy. There will be 2 groups each of~     25 - 30 participants who have chronic plantar fasciopathy, which is a common cause of foot~     pain. Exercises will be done for 6 weeks and then each group will do the other exercise~     protocol for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index~     scale and numerical analog pain scale and the Global Rating of Change Scale prior to any~     treatment, weekly during treatment and post treatment. The investigators' hypothesis is that~     use of the ThermaWedge™ device will result in decreased pain and disability when compared to~     achilles tendon stretching.~   "
41117|NCT02518828|"~     The primary objective of this pilot trial is to determine whether inpatients presenting to~     the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who~     receive supplemental oxygen adjusted at either a high (SpO2>97%) or low (SpO2~91%) oxygen~     saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.~   "
41118|NCT02518815|"~     This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic~     surgery prevented inadvertent post-operative hypothermia. Treatment group received~     prewarming using a forced air body warming, control group received no active warming system.~     Both groups were then warmed with forced air warmer intraoperatively.~   "
41119|NCT02518802|"~     This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin~     chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone~     in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma~     with EGFR activating mutation in Asian population.~   "
41120|NCT02518789|"~     By observing the difference of plasma homovanillic acid concentrations and brain electrical~     consciousness monitoring Narcotrend index, study the possible mechanism of influencing~     Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia~     induction period.~   "
41121|NCT02518776|"~     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible~     for physical disability but can also cause cognitive disturbances annoying social and~     professional life of patients with the disease. Various studies have shown that there was a~     breach of episodic memory, working memory, attention and executive functions regardless of~     the form of disease, disability or duration of disease progression.~      The main objective of this study is to investigate the influence of emotional components and~     executive processes on the components retrograde and anterograde episodic memory (thanks to~     an original paradigm based on the emotional valence of the memory) in MS patients~   "
41122|NCT02518763|"~     The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of~     French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility~     and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a~     suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from~     undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic~     regimens, specific to each clinician in the absence of precise data in the literature. No~     consensus on supplementation dosages and methods have been proposed so far. Also, given the~     frequency of vitamin D deficiency including osteoporosis observed in the population, it~     became necessary to establish a single, uniform regimen for all patients with osteoporosis~   "
41136|NCT02518581|"~     The present study is an exploratory trial to establish a feasible DLW (doubly labelled~     water) protocol for implementation in clinical trials conducted at Profil Institut für~     Stoffwechselforschung, investigating treatment options for overweight and obesity in~     populations with and without diabetic comorbidity. The study aims at the practical~     validation of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.~      Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as~     calculated based on individual anthropometric measurements (including body composition)~     using the Müller formula and the AEE (activity related energy expenditure) based on reported~     work place and leisure time activities and (2) TEE as calculated from measured REE (resting~     energy expenditure) as assessed by indirect calorimetry and the AEE based on information~     recorded by the subjects in a physical activity diary and corresponding pedometer counts.~     Moreover, TEE assessments will be repeated once (separated by 2-4 weeks) to determine~     intra-subject variability / re-test reliability of the measurement.~   "
41123|NCT02518750|"~     This is a phase-II study to evaluate the efficacy of a salvage regimen in children with~     relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT)~     (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly~     used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In~     this study, the investigators want to know if adding three drugs called panobinostat,~     bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no~     signs or symptoms of leukemia or lymphoma).~        -  Panobinostat has been approved by the FDA for treating adults with multiple myeloma,~          but it has not been approved for use in children and has not been given together with~          the other drugs used in this study. It has not been widely studied in children.~        -  VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has~          not yet been approved for treating children with leukemia or lymphoma.~        -  Bortezomib has been approved by the FDA for treating adults with a cancer called~          multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been~          approved for treating children.~      PRIMARY OBJECTIVE:~        -  To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic~          leukemia and lymphoma in first relapse.~      SECONDARY OBJECTIVES:~        -  To evaluate minimal residual disease (MRD) levels at end of each block of therapy.~        -  To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used~          in combination with chemotherapy and bortezomib.~   "
41124|NCT02518737|"~     The bone tissue of the human adult body is in a constant process of break-down (resorption)~     and rebuilding (formation), a process called bone remodeling. The extent to which bone~     remodeling happens varies during the day, especially a decrease in the bone resorption is~     observed after eating.~      The overall purpose of this study is to examine the possible role of the hormone~     Glucose-dependent Insulinotropic Polypeptide (GIP) in Bone Remodeling. GIP is released from~     cells in the gut after eating, and previous studies have shown an effect of GIP on bone~     tissue. In addition, it has been observed that the risk of bone fracture is 60% higher in~     women with a mutation in the GIP receptor, when compared to women with a normal functioning~     GIP receptor.~      In the present study humans with a mutation in their GIP receptor is compared to humans with~     a normal functioning GIP receptor. The study population will be examined during a meal~     stimulation test, where blood will be sampled regularly. The blood samples will be examined~     for markers of bone resorption among other markers of bone remodeling, GIP and other gut~     hormones.~      The hypothesis for the present study is that GIP secreted after meal ingestion inhibits bone~     resorption. Thus it is expected that the decrease in resorption is less pronounced in the~     humans carrying the GIP-receptor mutation, compared to humans with a normal functioning GIP~     receptor.~   "
41125|NCT02518724|"~     In order to examine the effect of RIPC on skeleton muscle exertional damage and on aerobic~     and anaerobic physical performances, 30 healthy volunteers will undergo a series of~     different physical tests twice; once without intervention and a second time with RIPC~     intervention or placebo (false) intervention.~   "
41126|NCT02518711|"~     The goal of this study was to investigate the effectiveness of a behavioral teacher program~     addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.~   "
41127|NCT02518698|"~     The goal of the study is to provide a detailed description of treatments for CRPC (Castrate~     Resistant Prostate Cancer) patients with bone metastases and the resource utilization and~     costs associated with that diagnosis and subsequent treatments.~   "
41128|NCT02518685|"~     The purpose of this clinical research trial is to study safety and effectiveness of the~     TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered~     medically obese.~   "
41129|NCT02518672|"~     Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would~     increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific~     metabolites involved in the resolution of inflammation.~      The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a~     randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate~     whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce~     lung inflammation and improve pulmonary function.~   "
41130|NCT02518659|"~     Hypomagnesemia is a severe side effect of longterm use of all available proton-pump~     inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.~      This study investigates the application of dietary inulin fibers in users of proton-pump~     inhibitors with such a hypomagnesemia. To this end, repetitive short-term trials of 14 days~     of orally administered inulin, separated by a wash-out period of 14 days each were performed~     in cases of PPIH and controls. This study was not blinded or randomized.~   "
41131|NCT02518646|"~     Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the~     early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not~     yet implemented as standard in clinical practice, as it is unknown which delirium prediction~     model can best be used to predict delirium in ICU patients.Therefore the main aim of this~     study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.~   "
41132|NCT02518633|"~     Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of~     cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea.~     Reduced adipose tissue oxygen availability has been described in obesity and may also be a~     mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose~     tissue which are factors contributing to cardiovascular risk. The investigators hypothesize~     that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by~     comparing in vivo AT oxygenation and blood flow in tissue of control subjects.~   "
41133|NCT02518620|"~     The objective of this study is to evaluate the long-term efficacy and safety of ALX-0061~     administered subcutaneously (s.c.) to subjects with active Rheumatoid Arthritis (RA).~   "
41134|NCT02518607|"~     This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment~     for Clostridium difficile infections.~   "
41135|NCT02518594|"~     This protocol outlines a randomized trial of 600 women evaluating the use of micronized~     vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in~     women carrying twins and with a cervical length of less than 30 millimeters.~   "
41139|NCT02518542|"~     Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as~     dysphagia, regurgitation, chest pain and consecutive weight loss.~      Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon~     dilatation (BD) can provide sufficient symptom relief in many patients, both interventions~     have their individual drawbacks. Additionally, treatment after failed LHM or BD can be~     challenging and in few might even lead to esophagectomy.~      Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel~     endoscopically performed therapeutic options for achalasia and other esophageal motility~     disorders. Both not only appear to provide good results, when performed as initial treatment~     but also might be an excellent option after e.g failed LHM.~      The purpose of this study is to evaluate the long-term efficacy of four different treatment~     options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an~     individualized treatment setting.~   "
41140|NCT02518529|"~     Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At~     or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT~     were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study~     duration 52 weeks).~   "
41141|NCT02518516|"~     Statins are a class of cholesterol lowering medications that are prescribed for the~     prevention and treatment of cardiovascular disease. The purpose of this study is to~     determine if there is an excess risk of acute kidney injury (AKI) with high potency statins~     compared to low potency statins.~      The investigators will carry out separate population based cohort studies using~     administrative health care databases in nine jurisdictions in Canada, the US, and the UK.~     Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization~     for AKI. Analyses will be done separately for groups of patients with and without chronic~     kidney disease. The results from the separate sites will be combined in a meta-analysis to~     provide an overall assessment of the risk of AKI in new statin users.~   "
41142|NCT02518503|"~     Statins are a class of cholesterol lowering medications that are prescribed for the~     prevention and treatment of cardiovascular disease. The purpose of this study is to~     determine if there is an increased risk of new diabetes when exposed to high potency~     statins, compared to low potency statins, among patients who had a recent cardiovascular~     event or procedure.~      The investigators will carry out separate population based cohort studies using~     administrative health care databases in eight jurisdictions in Canada, the US, and the UK.~     The cohort will be defined by the initiation of a statin, with follow-up until a diagnosis~     of incident diabetes or a prescription for insulin or an oral antidiabetic medication. The~     results from the separate sites will be combined in a meta-analysis to provide an overall~     assessment of the risk of new onset diabetes in subjects starting a statin.~   "
41143|NCT02518477|"~     This study will examine whether lymphedema after breast cancer surgery can be reduced. In a~     randomised controlled design the aim is to investigate whether an early intervention with~     progressive resistance training and close monitoring of arm swelling can reduce the~     incidence of lymphedema after breast cancer surgery.~   "
41144|NCT02518464|"~     This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the~     hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg~     PO twice a day) reduces episodic and/or chronic migraine headache symptoms in patients with~     right to left shunt. Headache frequency while on Brilinta/ticagrelor will be compared with~     the documented baseline for each subject. If the Brilinta/ticagrelor therapy was effective~     (> 50% reduction in monthly headache days), the subject could elect to continue therapy for~     an additional two months (56 days), while continuing to complete daily headache logs.~   "
41145|NCT02518451|"~     This was a randomized, single-blind, two-period, two sequence cross-over study under fasting~     condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and~     bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated~     caplets.~   "
41146|NCT02518438|"~     This double-blind, randomized trial examined whether tramadol wound infiltration decreased~     postoperative pain following cesarean delivery under general anesthesia or reduced the need~     for analgesics in the immediate postoperative period. Patients in the tramadol group~     consumed significantly less morphine at all time intervals than those in the control group.~     The investigators suggest that the use of wound infiltration with tramadol may be a useful~     technique in patients who undergo cesarean section under general anesthesia to reduce~     postoperative pain, improve recovery, and facilitate early contact of mothers with their~     babies.~   "
41147|NCT02518425|"~     In a retrospective analysis of already existing clinical assessment data from patients with~     functional voice disorders the following aspects will be sampled, encoded and analysed:~     Outcomes pre and post treatment of~        1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),~        2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain~          Scale (GRBAS Scale),~        3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and~          range of speaking pitch and intensity, max. intensity and mean pitch of calling voice,~          singing voice: min./max. and range of pitch and intensity, maximum phonation time,~          Dysphonia Severity Index (DSI).~   "
41148|NCT02518412|"~     The purpose of this study is to investigate transcranial direct current stimulation (tDCS)~     as a cognitive enhancer for patients with Alzheimer disease.~      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are~     applied to the brain by using two electrodes. These electrodes are placed on the scalp. The~     current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by~     increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the~     present study, participants will undergo six stimulations. The effect of all stimulations~     swill be measured with neuropsychological testing before the first (pre) and after the sixth~     tDCS stimulation (post).~   "
41149|NCT02518399|"~     The purpose of the study is to investigate whether long-term heat therapy (i.e. 8 weeks of~     hot tub 4-5x per week) improves biomarkers of cardiovascular health in young, healthy,~     able-bodied individuals. Although exercise is a potent means of improving cardiovascular~     health, many patients are unable to exercise effectively, and thus there is high demand for~     novel therapies to better manage cardiovascular risk in these patients. If successful, this~     study will set the groundwork for heat therapy to be used as an alternative treatment in~     patients who have limited exercise capabilities for the prevention of cardiovascular~     disease.~   "
41150|NCT02518386|"~     Acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency~     department visits. However, the exact epidemiology of acute self poisoning is not known. The~     description of the clinical pathway and the characteristics of patients with acute self~     poisoning could lead to an improvement in emergency care.~      The Investigators will conduct a 48h observational study in emergency services in France.~     Investigators primary objective is to gathered epidemiological clinical and treatment data~     during emergency dispatch, prehospital care and inhospital emergency care.~   "
41151|NCT02518373|"~     This Phase 2 study was an open label, single-center 18-week study to compare basal and meal~     stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections~     of 250 µg G17DT, with and without the concomitant administration of Omeprazole.~   "
41152|NCT02518360|"~     Determine the improvement in nonspecific low back pain patients with osteopathic techniques~     (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a~     stabilometric platform (Footscan®).~   "
41153|NCT02518347|"~     The proposed study aims to examine the hypothesis that strawberry supplementation will lower~     serum biomarkers of inflammation and improve knee function in patients with symptomatic~     osteoarthritis (OA).~   "
41154|NCT02518334|"~     Many studies have reported that alcoholic beverage consumption, especially in the form of~     wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association~     suggests that wine consumption may somehow improve the body's ability to control its blood~     glucose concentration. Indeed, it has been reported that when wine is consumed immediately~     prior to ingestion of glucose, the release of insulin is enhanced and blood glucose~     concentration is lowered. The mechanism of wine's effects on blood glucose concentration is~     unknown, but is likely related to its ethanol or antioxidant content. In this study, the~     investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the~     control of blood glucose in subjects who have diabetes or pre-diabetes.~   "
41155|NCT02518321|"~     Toileting is a private activity of daily living. Geriatric rehabilitation patients are often~     unable to toilet themselves independently, leading to embarrassment and loss of self-esteem.~     Relationships with their caregivers may also become strained. Furthermore, improper~     toileting hygiene can lead to skin irritation, breakdown and infection.~      Technology-assisted toilets (TATs) clean and dry the anal and vaginal regions using a stream~     of water and a fan. They can therefore potentially eliminate the need for patients to be~     able to wipe themselves. TATs are operated using wall-mounted remote controls. This study~     will examine the potential benefits of TAT use in geriatric rehabilitation patients.~      Forty patients aged ≥65 years referred for treatment of physical impairments to the~     Geriatric Rehabilitation Unit (GRU) of the Elisabeth Bruyère Hospital (EBH) will be~     recruited for this study. Participants will have a bowel movement on two occasions, once~     using toilet paper and once using the TAT. The Psychosocial Impact of Assistive Devices~     Scale (PIADS), a validated questionnaire, will be used to analyze participants' toileting~     experience. Participants will be visually evaluated for cleanliness before and after each~     testing session.~      The investigators hypothesize that participants will report that, in comparison with use of~     a standard toilet, toileting using the TAT: 1) is easier to use, 2) improves psychological~     well-being and 3) is more effective at cleaning than regular wiping techniques.~   "
41156|NCT02518308|"~     This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR)~     intervention works in reducing anxiety in patients who have undergone treatment for~     gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of~     the female reproductive tract, which includes the cervix, endometrium, fallopian tubes,~     ovaries, uterus, and vagina. Side effects from treatment for these cancers may include~     anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses~     meditation and yoga to help patients focus on breathing, bodily sensations, and mental~     awareness. This may help decrease patients' stress and anxiety and improve their quality of~     life, and may also help their immune system.~   "
41157|NCT02518295|"~     The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains~     help improve lactose digestion in subjects with lactose maldigestion.~   "
41158|NCT02518282|"~     A measurable degree of heart muscle tissue injury is expected in patients undergoing heart~     valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood~     samples. Those biomarkers are used to diagnose an acute myocardial infarction.~      Postoperative myocardial infarction (MI) is a frequent and important complication after~     cardiac surgery with high morbidity and mortality. Therefore it is very important to~     recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic~     tools can be used to the diagnosis of acute myocardial infarction; however few is known~     about the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart~     valvular surgery.~      The aim of this study is to determine the upper reference limit of high-sensitivity troponin~     T concentration to consider the diagnosis of acute myocardial infarction in patients~     undergoing heart valvular surgery.~   "
41159|NCT02518269|"~     The study is designed to compare three articulation options in terms of osteolysis, patient~     satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip~     score (HHS)) and safety.~      In addition, the purpose of the study is also to evaluate the safety and effectiveness of~     patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary~     total hip arthroplasty.~   "
41173|NCT02518087|"~     Our project intends to reduce acute kidney injury in non emergent cardiac surgery (AKI-CS)~     patients with the use of an increased adsorption membrane (OXIRIS®) connected to the~     cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by~     quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a~     randomized and controlled multicentre trial that includes recruiting centres with a long~     experience in cardiac surgery with CPB.~      The primary endpoint of the project is to evaluate the ability of OXIRIS® to reduce the~     incidence of AKI-CS in patients undergoing non emergent cardiac surgery with CPB. With the~     goal of reducing by 10% (from 15 to 5%) the risk of AKI-CS during the first postoperative~     week a sample size of 340 patients has been calculated.~      Secondary endpoints are two; first, to evaluate the effect of using OXIRIS® on survival,~     clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and~     after CPB; and second, to assess the predictive value for AKI-CS of some new biomarkers,~     such as uNAD (urinary nicotinamide adenine dinucleotide).~   "
41160|NCT02518256|"~     The ovarian surface, the Fallopian tubes, the uterine cavity and the peritoneal cavity all~     together form a communicating compartment. The physiologic function of the ciliated lining~     of the tubes is to transport the egg, after ovulation, into the uterine cavity. Thus, making~     it very likely that exfoliated cells from pathologic changes of the ovarian surface and~     Fallopian tube lining will be present in a lavage from the uterine cavity.~      The proof of concept that malignant cells from the upper genital tract get transported even~     into the lower genital tract was recently published by Kind I. et al. Liquid-based cervical~     cytology allows not only cytological evaluation but also collection of DNA. A panel of genes~     that are commonly mutated in endometrial and ovarian cancers was assembled with new~     whole-exome sequencing data from 22 endometrial cancers and previously published data on~     other tumour types, including mutations in the TP53 gene. This panel was used to search for~     mutations in 24 endometrial and 22 ovarian cancers and identified mutations in all 46~     samples. With a sensitive massively parallel sequencing method, it was possible to identify~     the same mutations in the DNA from liquid Pap smear specimens in 100% of endometrial cancers~     (24 of 24) and in 41% of ovarian cancers (9 of 22).~      In the current project the investigators will study the specificity and sensitivity of the~     lavage of uterine cavity and proximal tubes as a test to differentiate between malign and~     benign ovarian tumours. The investigators aim to detect cells from EOCs or genetic material~     from those cells in the lavage.~   "
41161|NCT02518243|"~     All over the world the increasing prevalence of chronic disorders and its impact on~     functional decline is challenging the sustainability of health care systems. Older~     individuals also frequently experience the reversible frailty syndrome, which overlaps~     with chronic diseases, increasing incidence of disability.~      Building a global system aiming to take in charge all causes leading to loss of autonomy is~     a rather complicated task involving numerous Information and Communication technologies~     (ICT) solutions which are not always easy to use in everyday life.~      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality~     of life of older people at risk.~      The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation~     aromatherapy automatic fragrance ...) .~      The goal of this study is to validate the acceptability, sensitivity and efficacy of the~     systems.~   "
41162|NCT02518230|"~     This study is a single center, prospective cohort crossover study comparing mechanically~     ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and~     synchronized intermittent mandatory ventilation with pressure control plus pressure support~     (SIMV(PC) + PS) modes.~      This design will allow for direct comparison of two commonly used ventilator modalities in~     the neonatal intensive care unit (NICU) to determine if one mode is superior to the other~     with regards to respiratory mechanics and estimated energy expenditure.~      It is hypothesized that neonates and infants will have improved respiratory severity score~     (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased~     estimated energy expenditure.~   "
41163|NCT02518217|"~     This randomized controlled trial will evaluate patterns of use and health outcomes of the~     ShapeUp Empower online program with and without financial incentives for program engagement.~   "
41164|NCT02518204|"~     The purpose of this study is to evaluate the concurrent validity between the Brain~     Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological~     assessments (NP).~   "
41165|NCT02518191|"~     This prospective randomized controlled study is conducted to analyze the effect of Goserelin~     on ovarian function in women with breast cancer in China.~   "
41166|NCT02518178|"~     This is a three arm cluster randomized controlled trial where the unit of randomization is~     the immunization camp. Immunization camps are the sole provider of vaccinations in our study~     area and have catchment areas of several villages. The 96 immunization camps will be~     randomized evenly to one of three arms:~        1. control arm; where near field communication (NFC) stickers will be placed on existing~          immunization booklets. These stickers can be scanned using a mobile phone with an~          installed application whereby information can be entered onto the phone and then~          scanned onto the sticker~        2. pendant only; where the same NFC technology will be placed into a pendant that is worn~          by the infant, and~        3. pendant as described above with voice reminders sent 15 days, 1 day prior, and the day~          of the scheduled immunization camp dates.~   "
41167|NCT02518165|"~     This study was designed to evaluate the chronic effects of a proprietary spearmint extract~     over 90 days of supplementation on aspects of cognitive performance (cognitive function and~     active reaction time), subjective mood, and sleep quality in healthy men and women.~   "
41168|NCT02518152|"~     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin~     (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony~     defects in chronic periodontitis patients.~   "
41169|NCT02518139|"~     The purpose of this study is to measure the safety and tolerability of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to tiotropium.~   "
41170|NCT02518126|"~     To see if there is a relationship between the level of LIF in IUGR fetuses and compared to~     the level of LIF in AGA fetuses~   "
41171|NCT02518113|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic~     leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).~   "
41172|NCT02518100|"~     This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and~     monitor specified vital signs. It will be used in parallel with the normal equipment the~     study site uses to take and monitor vital signs.~   "
41174|NCT02518074|"~     The investigators objective is twofold. Investigators propose to study how the vestibular~     and auditory information interact in the construction of coherence between the staff and~     extrapersonal space.~      Furthermore, investigators want to investigate whether, even in the absence of gravity, the~     auditory spatial information allocentric provide a framework for spatial reference.~   "
41175|NCT02518061|"~     This is a retrospective study that involves the revision of clinical, instrumental and~     pathologic data of an estimated cohort of maximum 145 patients with glioma treated with~     surgery with radical intent at our center.~   "
41176|NCT02518048|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam~     compared with Betesil® medicated plaster~   "
41179|NCT02518009|"~     Gender dysphoria (DSM-5) or transsexualism (ICD10) is a condition in which a person's~     feeling of gender identity is not congruent with the physical body. The hormonal treatment~     includes inhibition of one's own sex hormone production followed by treatment with~     testosterone or estrogen levels that are normal for the opposite sex. Seen as experimental~     model, this is a process that provides an opportunity to study the sex hormone dependent~     influences that explain differences in morbidity in men and women respectively. The~     differences that are especially significant but not well known is 1) metabolic changes in~     the regulation of glucose homeostasis and lipid metabolism 2) regulation of vascular~     function and structural effects on the heart and arteries 3) regulation of skeletal muscle~     mass and fat tissue 4) morphological and functional effects on discrete areas of the brain.~      Therefore, the investigators will follow these patients for a year to study how the heart,~     blood vessels, brain, and risk factors for cardiovascular disease affected by altered sex~     hormone patterns and studying what happens in the muscles and fat in both the short and long~     term with respect to particular gene expression and epigenetic changes and link it to~     metabolic changes and body composition.~   "
41180|NCT02517996|"~     Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition~     that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its~     public health importance the pathogenesis of IC/PBS is not well understood and there is no~     consensus on the optimal treatment approach for this condition. Hydrodistention is the most~     commonly used therapy for this condition; but it is limited by severe immediate~     postoperative bladder pain and its short duration of action. It has been postulated that~     hydrodistention works by disrupting the sensory nerves within the bladder that may be~     contributing to bladder pain. Recent evidence has provided support for the use of preemptive~     pudendal nerve block as a way to blunt immediate postoperative pain. The investigators~     hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in~     lower postoperative pain after hydrodistention compared to placebo. This is a prospective~     double- blinded randomized study and patients will be randomized to receive preemptive~     bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder pain will be~     compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale,~     O'Leary-Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.~   "
41181|NCT02517983|"~     World Health Organization (WHO) considers chronic respiratory disease (CRD) as one of its~     four priorities. These diseases include asthma and rhinitis, chronic obstructive pulmonary~     diseases (COPD), occupational lung diseases, sleep apnoea syndromes, pulmonary hypertension,~     bronchiectasis and interstitial lung diseases. They constitute a serious public health~     problem in all countries throughout the world, in particular in low and middle income~     countries and in deprived populations. Hundreds of millions of people of all ages, in all~     countries of the world, are affected by chronic respiratory diseases. More than 50% of them~     live in low and middle income countries. Over 90% of deaths and the complete inability, due~     to CRDs occur in countries with low or middle incomes.~      The main causes of CRD are: tobacco smoke, occupational factors, indoor air pollution and~     outdoor air pollution, allergens, sequelae of respiratory infections such as tuberculosis.~      More than 30% of the population of Ho Chi Minh City (HCMC) could develop a CRD. In fact, 15%~     of children and 7% of adults could become asthma and 6% of the population could become COPD~     due to smoking. Children exposed to fumes from biomass burning, early in their life, seem to~     have a higher risk to develop COPD. The high level of air pollution in HCMC could aggravate~     asthma / COPD. Populations combining the rural risk (exposure to smoke from biomass) and the~     urban risk (smoking, pollution) may develop COPD much earlier (before age 40). Among the 9~     million people in HCMC, 50% of the population is rural origin. Within this population,~     parasites could play a protective role against the risk of allergic asthma and consequently,~     the better control of helminthiasis among urban population, may result in allergic diseases~     such as asthma and anaphylaxis. Finally, the sequelae of tuberculosis (incidence is~     200/100000) could participate to the morbidity of COPD / CRD.~      Study granted by the ARES-CUD (Comission universitaire au développement)~   "
41182|NCT02517970|"~     The objective of the proposed research is to conduct a within-subject experimental study~     that will assess the effect of environmental distractions on a mothers' ability to recognize~     and feed in response to infants' feeding cues. Investigators hypothesize that mothers will~     spend significantly more time looking at their technology compared to looking at their~     infant, which will be negatively associated with the mothers' responsiveness to her infant.~     This will have a positive association with infant intake during the feeding. Investigators~     also hypothesize that mothers will show less sensitivity when distracted when compared to~     when they are not distracted.~   "
41183|NCT02517957|"~     On the basis of Xiashi skin surgery clinical experience, this project adopts the~     multicenter, randomized, double-blind, controlled trial of design type. Objective, normative~     evaluation of traditional Chinese medicine cool blood latent town effectiveness of~     therapeutic regimen in the treatment of eczema, security, and control of the relapse of~     situation, provide high-level evidence-based basis for traditional Chinese medicine~     treatment of eczema, aims to form suitable for popularization and application of traditional~     Chinese medicine in the treatment of eczema.~   "
41184|NCT02517944|"~     Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from~     silent micro-infarctions (MI) before clinical coronary heart disease manifestations because~     of the lifetime exposure to elevated serum LDL-cholesterol levels.~      The study aims to demonstrate the higher prevalence of silent myocardial infarction in a~     population of asymptomatic patients with familial hypercholesterolemia at high~     cardiovascular risk in comparison to control patients using Cardiac Magnetic Resonance~     sequences of delayed gadolinium enhancement.~   "
41185|NCT02517931|"~     This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural~     puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive~     a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo~     nerve block.~   "
41186|NCT02517918|"~     This is a prospective open-labeled phase I trial based on a dose escalating study design~     assessing two dose levels of sirolimus when prescribed in combination with metronomic~     cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion~     cohort once the Maximum Tolerated Dose (MTD) is established.~   "
41187|NCT02517905|"~     This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled~     to undergo elective bilateral third molar extraction under local anesthesia. At least one~     lower mandibular third molar must involve full or partial bony impaction confirmed by visual~     or radiographic evidence.~   "
41199|NCT02517749|"~     This is a multicentre randomised controlled trial evaluating global health related quality~     of life outcomes in patients with malignant pleural effusions. Patients will be randomised~     to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc~     pleurodesis. Patients will be followed up for 3 months post intervention~   "
41188|NCT02517892|"~     This is a prospective study to identify molecular mechanisms of acquired resistance to~     targeted therapies in patients with unresectable or metastatic cancer.~      This is a protocol to study clinical characteristics and biopsy tissue of patients with~     oncogene-driven cancer who have had previous clinical response to targeted therapy and~     subsequently experience progression of disease. The tissues and other specimens will be used~     to carry out laboratory studies to explore the molecular basis of acquired resistance to~     targeted therapies.~   "
41189|NCT02517879|"~     All households in three zones in Zambia's Eastern Province were invited to attend a~     community point distribution of insecticide treated bed nets (ITNs). Households were then~     randomized to different intervals for a community health worker (CHW) hang-up visit.~   "
41190|NCT02517866|"~     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil~     (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.~   "
41191|NCT02517853|"~     The aim of this study is to evaluate the efficiency of the Neuroestimulation of the~     Posterior Tibial Nerve for the treatment of this syndrome.~      A multicentric, prospective, randomized study will be performed in patients affected with~     severe LARS symptoms. Patients will be randomized in two groups:~        1. Control group- placebo~        2. Treatment group: neuroestimulation of the posterior tibial nerve~   "
41192|NCT02517840|"~     The rise in life expectancy implies an increased number of nonagenarian patients who need~     evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether~     revascularization techniques in these patients fulfill a set of security and efficacy~     criteria generated from surgical results in a validated historical cohort.~   "
41193|NCT02517827|"~     The endovascular therapy prevailed in nearly all regions of peripheral artery disease over~     open surgery techniques. However, in treatment of the common femoral artery vascular surgery~     is still the gold standard of therapy. One-year patency rates are between 90% and 95%.~     Today, only in selected cases an endovascular procedure for common femoral artery diseases~     is recommended.~      The primary objective of this study is to compare the performance of directional atherectomy~     and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions~     in a prospective, multi-center, randomized clinical trial.~   "
41194|NCT02517814|"~     Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently~     reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies.~     It was found that vitamin D supplementation improved the heart function. The purpose of this~     study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin~     D supplementation in cases where there is a deficiency, improves heart functioning.~   "
41195|NCT02517801|"~     Anthocyanins are the most common polyphenols in berries and red wine, along with other~     flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized~     and they are transformed into glucuronides and phenolic acids. The investigators have~     recently shown that the acute consumption of blueberries leads to an increase in~     endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male~     volunteers. There were significant correlations of these effects with the plasma~     concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study~     aims at understanding to which extent the anthocyanins contained in berries are related with~     positive effects in endothelial function. A large part of the absorbed anthocyanin circulate~     in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids.~     The formation of these metabolites begins right as early as 2h after consumption due to~     metabolism at the small intestine and a second plasmatic peak occurs around 6h due the~     metabolism of colonic bacteria. Whether and which metabolites are associated with biological~     effects and the mechanisms underlying this effect remains unclear.~   "
41196|NCT02517788|"~     Phase I study aiming at:~        -  establishing the pharmacokinetic profile of interferon beta-1a after i.v.~          administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free~          solution in pre-filled syringes) at 18 MIU;~        -  investigating the possible impact of albumin on pharmacokinetic profile by comparing 3~          different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution~          in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif®~          from Merck-Serono, a registered IFN beta-1a solution containing HSA;~        -  establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in~          HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals~          against Rebif® using the same regimen.~   "
41197|NCT02517775|"~     Accumulating evidence from epidemiological and human intervention studies indicates that the~     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related~     to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in~     particular anthocyanins, but also phenolic acids. At present, a small number of randomized~     controlled trials investigating the effects of berry (poly)phenols on validated surrogate~     markers of cardiovascular disease risk has shown promising results. However, to date, very~     few human studies have specifically investigated the effects of cranberry (poly)phenols on~     cardiovascular function in healthy subjects. To our knowledge, no study has investigated the~     time and intake-dependent effect of cranberry consumption on vascular function in healthy~     subjects. This information is necessary for the planning of long-term studies aiming to~     assess the potential beneficial effects of cranberries, using optimal amounts at optimal~     time points. Therefore, this study aims to investigate the potential role of cranberry~     (poly)phenols in the modulation of vascular function by monitoring changes in vascular~     function together with the major (poly)phenol derivatives/metabolites in plasma and urine.~   "
41198|NCT02517762|"~     The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the~     cause of pain, evaluation of treatments and development. Employees from a large local~     manufacturing company are sent for a complete orthopedic and pain evaluation immediately~     after onset of acute low back pain. Thereafter, the included patients are allocated either~     to the advice to stay as active as possible in spite of the pain or to adjust their activity~     to the pain. Pain intensity and physical activity are followed prospectively over seven days~     using a diary and a pedometer.~   "
41200|NCT02517736|"~     The objective of the study is to determine the efficacy and toxicity of sorafenib in~     metastatic uveal melanoma.~      The main objective is to determine the non-tumor progression rate 24 weeks after initiation~     of treatment with sorafenib at a dose of 800 mg / day~   "
41201|NCT02517723|"~     Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable~     for survivors of prolonged and repeated exposure to traumatic stress and childhood~     adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid~     Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims~     are the reduction of PTSD-Symptoms in these patients via activation of associative neural~     networks related to traumatic experiences and habituation of fear and the placement of~     traumatic experiences in a reconstructed, detailed and consistent autobiography. This~     practice enables the processing of and coping with painful memories and the construction of~     clear contingencies of dangerous and safe conditions, generally leading to significant~     emotional recovery. The investigators assume that using NET the reduction of PTSD symptom~     severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).~   "
41202|NCT02517710|"~     Prospective single blinded trial comparing standard synthetic suture material to a synthetic~     barbed suture in closure of uterine incision, during Cesarean section procedures.~   "
41203|NCT02517697|"~     The objective of the study is to investigate effects of inorganic sodium nitrite on the~     cardiometabolic and hormonal disturbances observed in a targeted population of~     overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin~     resistance and endothelial dysfunction.~   "
41204|NCT02517684|"~     The purpose of this study is to determine whether a top-down treatment approach, prescribing~     infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to~     the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral~     nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.~   "
41205|NCT02517671|"~     The purpose of this study is to assess the effects of 35 EECP sessions on cardiopulmonary~     training performance in healthy volunteers. Data from this study will be used to generate~     sample size and power calculations for feasibility of future EECP studies. The results of~     this study could provide evidence that can help active duty and Department of Defense~     beneficiaries optimize physical conditioning, endurance and overall health.~   "
41206|NCT02517658|"~     The study will involve parents filling out a survey before & after watching a teaching tool~     video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op~     teaching. The parents randomized to the video arms will watch the video while their child is~     in the OR and then either take the post survey immediately after or wait to take the survey~     until just prior to discharge. Parents not in the video arms of the study will also be asked~     to complete a survey pre and post standard pain management teaching.~   "
41207|NCT02517632|"~     The aim of this investigation is to evaluate the impact of exercise in a cardiac~     rehabilitation program on functional capacity, clinical markers, quality of life and~     biomarkers in patients with chronic chagasic cardiomyopathy.~   "
41208|NCT02517619|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis~     with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with~     non-infectious anterior segment uveitis.~   "
41209|NCT02517606|"~     Chronic nonspecific low back pain is an important health condition with a high prevalence~     worldwide and it is associated with enormous direct and indirect costs to the society.~     Clinical practice guidelines show that many interventions are available to treat patients~     with chronic low back pain, but the vast majority of these interventions have a modest~     effect in reducing pain and disability. A biomechanical approach that has been raised is~     that a weakness of the hip abductors, extensors, and lateral rotators musculature~     (posterolateral complex - PLC) would lead to excessive contralateral pelvic drop during~     weight-bearing activities such as walking, running, climbing up or downstairs, generating an~     overload in the lumbar area. Although the strengthening of the hip PLC is largely used in~     clinical practice for treating patients with hip and knee injuries, there is still a lack of~     evidence regarding patients with low back pain. Therefore, questions remain about the~     efficacy of the hip dynamic stabilization as an additional intervention to conventional~     treatment in a well design trial with statistic power.~   "
41210|NCT02517593|"~     The primary aim of this study is to determine if the addition of an individual polygenic~     risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk~     Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast~     cancer in making a decision to take (or not take) medications to prevent breast cancer~   "
41211|NCT02517580|"~     This study is a single arm, single center clinical trial that aims to evaluate the effect of~     8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in~     stable renal transplant patients.~   "
41212|NCT02517567|"~     The purpose of this study is to evaluate the tear film evaporation of symptomatic soft~     contact lens wearers in the absence of contact lens wear and after at least 8 hours of~     contact lens wear.~   "
41213|NCT02517554|"~     The goal of this research is to evaluate the relative advantage of remote counseling over~     usual care in community health practices without access to genetic services. We will~     evaluate ability of remote telemedicine, referred to going forward as TeleGenetic services~     (phone or videoconferencing), to increase uptake of genetic testing and identification of~     genetic carriers compared to usual care. Secondly, we will evaluate the advantages of~     videoconferencing over telephone for delivery of remote genetic services and the short-term~     and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients~     in community practices.~   "
41214|NCT02517541|"~     The aim of the study is to obtain an understanding of relevant parameters affecting the~     performance of ostomy products.~   "
41215|NCT02517528|"~     This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT~     450/r/ ABT 267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks in HCV genotype~     1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV~     treatment-experienced Asian adults with compensated cirrhosis.~   "
41216|NCT02517515|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study~     evaluating ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced adults~     with subgenotype 1b chronic HCV.~   "
41218|NCT02517489|"~     Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is~     between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate~     pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of~     inflammation-associated systemic complications. Two recent meta-analyses suggest a positive~     effect on severe CAP day 28 survival when CTx are added to standard therapy. However they~     are based on only four trials gathering less than 300 patients, of which only one was~     positive. Recently published guidelines do not recommend CTx as part of CAP treatment.~     Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more~     specifically hydrocortisone - could improve day 28 survival of critically-ill patients with~     severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class~     V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.~      A phase-III multicenter add-on randomized controlled double-blind superiority trial~     assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in~     addition to antibiotics and supportive care, including the correction of hypoxemia.~      Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the~     time of inclusion.~   "
41219|NCT02517476|"~     The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of~     early nutritional therapy in regard to effectiveness, safety and costs when applied to the~     heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the~     question about overall benefit or harm, but using a physio-pathological mechanistic~     approach, it also will explore and provide conclusive answers about whether, why, how, and~     in which patient populations nutritional therapy does and does not works.~   "
41220|NCT02517463|"~     This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.~      Women attending the Family Planning Association of Hong Kong (FPAHK) for emergency~     contraception within 120 hours of UPSI were recruited. Subjects were recruited from both the~     Birth Control Clinics and Youth Health Care Centres of the FPAHK.~      Depending on the timing in relation to ovulation in the current menstrual cycle at the time~     of presentation, the women were classified into two groups:~      Group 1: pre-ovulatory Group 2: post-ovulatory~      After counseling and obtaining informed consent, eligible subjects received a single dose of~     ulipristal acetate 30 mg (ellaOne®) under direct supervision. A baseline blood test for~     hormonal profile (LH, oestradiol and progesterone) and ultrasound scan for ovarian follicle~     assessment were carried out by a designated doctor or research nurse at the clinic visit.~      The subjects were advised not to have further acts of coitus before the return of~     menstruation. They were given a diary chart to record vaginal spotting and bleeding,~     possible side effects and further acts of intercourse, if any, and the contraceptive method~     used. A follow-up appointment were be arranged about 1-2 weeks after the expected next~     menstruation. Any events of unplanned pregnancy and adverse effects were recorded for~     analysis.~   "
41221|NCT02517450|"~     This study tested the effectiveness of an adventure-based training programme in promoting~     the psychological well-being of primary schoolchildren. A randomised controlled trial was~     conducted, with 56 primary school pupils randomly assigned to the experimental group~     participating in the adventure-based training programme and 64 to the attention placebo~     control group.~   "
41222|NCT02517437|"~     The purpose of this study is to determine whether the combination of suprascapular and~     axillary nerve blocks is non-inferior to the conventional interscalene block (ISB) in~     providing pain relief during the first postoperative day to adult healthy patients (age >~     18) undergoing ambulatory shoulder surgery.~   "
41223|NCT02517424|"~     The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in~     participants with chronic, treatment-resistant posttraumatic stress disorder.~   "
41224|NCT02517411|"~     Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by~     incompletely reversible airflow obstruction. It is projected to be the fifth leading burden~     of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in~     COPD patients, and it has been previously shown that COPD patients suffer deterioration in~     their quality of life. The objective of this study is to examine the effects of a physical~     therapy intervention in stable patients with COPD.~   "
41225|NCT02517398|"~     The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose~     levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means~     the study drug has not previously been given to humans or has only been given to a limited~     number of people, although it has been extensively studied in animals. Based on this~     information, it is hoped to find out which dose could be best for the treatment of patients.~     There are two parts of this research study: a dose-escalation part and an expansion part.~     Dose escalation means that the first people taking part in the study will receive low doses~     of the study drug, and as more people take part, the additional participants will receive a~     higher dose. This is done to find the safest dose for the study drug. Expansion means that~     after the dose-escalation part of the study has looked at the safety and effectiveness of~     different doses, many more people will be invited to take part in the study and will receive~     the study drug at the safest dose. Additional purposes of the study are to find out whether~     the study drug has anti-cancer effects and how the study drug is processed by the body.~   "
41226|NCT02517385|"~     Primary Objective:~      To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day~     for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.~      Secondary Objectives:~      To assess effectiveness on symptomatic improvement in patients with gastrointestinal~     symptoms in acute and chronic liver diseases.~      To monitor compliance.~   "
41227|NCT02517372|"~     This study is a single-centre, open-label, dose escalation , safety, tolerability and~     pharmacokinetics (PK) study in healthy male and female subjects. The study include a~     screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and~     each cohort will include 8 subjects. there will be 24 subjects total included in the study.~     The duration of the clinical part of the study will be approximately 2 months.~   "
41228|NCT02517359|"~     RV6153 is a new medicine being developed for possible treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics~     and pharmacodynamics of single and repeat doses of RV6153~   "
41230|NCT02517333|"~     The importance of play and physical activity include its many benefits on positively~     improving health and well-being, enhancing children's and young people's thinking and~     performance in school, improving their sleep and enabling confidence and skill building~     (Janssen and LeBlanc, 2010; Budde et al., 2008; Sallis and Patrick, 1994). However, children~     with movement difficulties (MD) and physical disabilities are at risk of decreased physical~     activity and subsequently decreased physical fitness and overall health and well-being as a~     result. To build upon current findings and to follow-up on a continuing study, looking at~     the impact (responses) and recovery during and following acute exercise at different~     intensities in children and adolescents with and without movement difficulties, this next~     phase aims to provide an intervention to improve fitness levels and health measures and to~     strategically provide a pathway for longer term participation in physical activity in young~     people. Implement and evaluate a pathway to sport for 14+ year old young people who do not~     regularly participate in sport due to Neurodevelopmental conditions, young people presenting~     with poor coordination and movement, and even children and adolescents with special~     educational needs. The pathway hopes to promote engagement, participation, inclusion and~     confidence (EPIC) in sport within local schools and the community through 1) targeted~     recruitment, 2) confidence and skill building (EPIC Club), 3) connection to sport ('Have a~     go days') and 4) exit to long term participation.~   "
41231|NCT02517320|"~     The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic~     nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the~     first morning void urine sample as an indicator.~   "
41232|NCT02517307|"~     The purpose of this study is to learn more about what causes insulin resistance. It has been~     suggested that proper breakdown of fat into energy (oxidation) in the body is important to~     allow insulin to keep blood sugar in the normal range. The investigators want to know if~     having one of the fatty acid oxidation disorders could have an influence on insulin action.~     Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that~     converts fat into energy. The investigators will study both normal healthy people and people~     with a long-chain fatty acid oxidation disorder.~   "
41233|NCT02517294|"~     Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal~     tube during nasotracheal intubation in children undergoing general anesthesia for dental~     surgery.~   "
41234|NCT02517281|"~     The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in~     patients treated using targeted therapies in order to have a better understanding of the~     skin pathophysiology.~   "
41235|NCT02517268|"~     This randomized clinical trial studies accelerated recovery pathway for discharge after~     surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may~     improve outcomes after surgery following complex abdominal operations resulting in a shorter~     length of stay in patients with pancreatic cancer. It may also help patients to mobilize~     more quickly and return to the home setting, decrease hospital-acquired infectious~     complications, and increase potential cost savings. It is not yet known whether an~     accelerated recovery pathway is better than a standard recovery pathway for discharge~     following surgery in patients with pancreatic cancer.~   "
41236|NCT02517255|"~     Atherosclerotic disease is responsible for one third of all deaths annually and is a major~     cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads~     to complications such as acute myocardial infarction with ST-segment elevation. Rescue~     angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing~     mortality and the amount of myocardium effectively saved are not well established. The~     development of new tools, including cardiac magnetic resonance imaging to identify~     myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the~     context of primary angioplasty, little is known about the relation between coronary~     epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The~     objective of this study is to evaluate whether there is a relation between these flows and~     myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this~     research, the investigators hope to contribute to a better understanding of coronary flow~     and its relation to the amount of heart muscle saved after rescue angioplasty. This is an~     important information that can help understand which cases benefit most from rescue~     angioplasty.~   "
41237|NCT02517242|"~     This is a prospective, intervention, randomized, phase IV study. Patients will be included~     with 60 years or older, both sexes, with HbA1c >8.5% using oral antidiabetics agents and~     insulin and then we will be randomized by use syringe or pens device to use insulin NPH and~     regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood~     glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients~     will see monthly.~   "
41238|NCT02517229|"~     The scientific goal of this experiment is to evaluate changes in balance control in response~     to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular~     parameters under microgravity are compared to normal gravity conditions. To induce postural~     responses among the test subjects, an electromagnetic maneuverable postural platform will be~     used in order to randomly elicit perturbations. Postural reactions will be quantified by~     means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation~     will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex~     measurements were chosen as they allow reliable information about inhibitory and~     facilitatory mechanisms taking place at the spinal level.~   "
41249|NCT02517073|"~     The mechanical ventilation strategy has changed over years worldwide. Several international~     researches have been conducted to study the association of the use of mechanical ventilation~     with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the~     practice of mechanical ventilation among patients with severe brain injury will be~     investigated in 70 intensive care units in China.~   "
41250|NCT02517060|"~     The investigators measure brain responses of healthy participants while they perform~     evaluation tasks inside the fMRI. For each task the participants were primed with tactile~     stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming,~     hence confirming embodiment theories.~   "
41348|NCT02515773|"~     A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and~     healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body~     weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and~     Quality of Life.~   "
41239|NCT02517216|"~     Weightlessness profoundly modifies many physiological systems and especially the nervous~     system and the vestibular system. The changes in the nervous system are based in part on~     brain plasticity mechanisms, that is to say on modifications of neurons and their~     connections. They are the source of some of the behavioral response observed in the~     parabolic flight or in astronauts. For example, it is commonly observed that in the second~     and third days of parabolic flight campaigns with 3 flights, fewer participants are prone to~     motion sickness during the first day. Similarly, during their first trip into space,~     astronauts suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness -~     while this proportion is much lower in the second trip.~      The hypothesis of this study is that short-term weightlessness as well as changes in the~     level of gravity experienced during parabolic flights, induce neuroplascity phenomena in~     brain regions involved in the integration of vestibular, visual and proprioceptive.~      The goal is to objectify these plasticity phenomena, and assess their changes over time,~     using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical~     image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging~     - DTI) will visualize nerve bundles and their journey in the brain. The total duration of~     this review will be about ¾ hour.~      The results of this study will be compared with those of an ongoing study of 12 astronauts~     who have the same MRI scans taken before and after a trip to the International Space~     Station. Investigators can then evaluate the effect of duration of exposure to~     weightlessness on the phenomena of neuroplasticity.~   "
41240|NCT02517190|"~     From previous parabolic flight campaigns completed by our research group investigators~     gathered data showing important changes in neuro‐endocrine and also immunological changes.~     This experiment now will complete the data set‐up obtained during the MARS500 study on how~     these respective individuals will re‐act to highly physically and emotionally challenging~     situations during a parabolic flight.~      This add‐on experiment to MARS500 will enable answering to the following questions i) if the~     stress response systems - when compared for two conditions but in the same individuals - do~     react uniformly and ii) if those subjects prone to have adequate stress response pattern~     will show gradually less immune modulation effects.~      The understanding of the complex interactions of stress and immunity under chronic and acute~     stress conditions might help to enable adequate health and immune monitoring and might as~     well suggest suitable countermeasures for the prevention of the unwanted immunological~     effects during long‐term confinement and space missions.~   "
41241|NCT02517177|"~     As a direct consequence of exposure to microgravity, astronauts experience a number of~     physiological changes which can lead to serious medical implications. Most immediate and~     significant is the headward shift of body fluids and the removal of gravitational loading~     from bone and muscles, resulting in progressive changes of the cardiovascular and~     musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has~     been demonstrated in studies of short term (shuttle) and long term missions to Skylab and~     MIR.~      Our main hypothesis is that there is a linear relationship between the gravity level (0G,~     0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate~     variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral~     analysis of HRV and BPV.~   "
41242|NCT02517164|"~     Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least~     twice. These falls can have serious consequences that are a significant threat to the~     independence and well-being of older people. From an economic perspective, the cost of~     medical care related to falls and resulting injuries is very high and continue to grow with~     the aging of the population. Therefore falls prevention is a public health priority.~      Many data suggest that cognitive, common disorders in the elderly, is a major risk factor~     for falls and the elderly often have difficulty managing their parallel postural stability~     and other situations requiring attentional resources. Furthermore, the data used to evoke a~     role of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial~     effects on muscle and on the human brain and several recent studies have shown the existence~     of positive relationship between serum 25 hydroxyvitamin D and cognitive function. These~     different actions may explain the beneficial effect of vitamin D supplementation on the risk~     of falling for practicing daily oral doses of vitamin D in the range of 700-1000 IU.~      Our goal in this study is to confirm the existence of a link between vitamin D status and~     some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and~     cognitive impairment in the occurrence of falls. The study will also seek the existence of a~     threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The~     prospective follow-up of patients for 2 years will study the effect of correcting the~     vitamin D deficiency (initial correction and regular supplementation) on cognitive function,~     balance, walking and the occurrence of falls.~      The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects~     aged 50 and over at risk of falling. These patients will be enrolled in the Emergency~     Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All~     subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive~     function, tests of balance and walking and assessment of activities of daily living and~     depression. All the examinations and tests will be carried out during the same half day.~     According to current recommendations, it will be prescribed a treatment with Vitamin D to~     subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and~     will be advised doctors to prescribe regular supplementation vitamin D in order to maintain~     it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis~     D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance~     and walking will be analyzed 3 months and 9 months. During the two years following their~     inclusion in the study, subjects will be contacted by a phone call every 3 months during~     which will be recorded any falls they have been victims, as well as changes to their drug~     treatments, particularly case of regular intake of vitamin D supplementation.~      If our hypothesis were true, it would be appropriate to consider a new approach to~     prevention of fractures involving the correction of vitamin D deficiency, cognitive~     rehabilitation and cognitive-motor drive in subjects with cognitive impairment.~   "
41243|NCT02517151|"~     A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron~     supplementation on chronic fatigue in IBD patients with controlled disease.~   "
41244|NCT02517138|"~     The goal of this study is to objectively determine the perceived direction of the~     right-front by the subjects in weightlessness. The direction of the right-front has not been~     investigated to date with the measurements of the position of the eyes. The investigators~     will compare the intersection of the horizontal and vertical saccadic trajectories (jerky)~     with the apparent direction of the right-front indicated by the subjects when they look~     right front in the dark (LOOK) and that they indicate when they determine whether a visual~     target through the right-front apparent (PERCEPTION). Then, the investigators will compare~     these measurements between normal gravity and microgravity hypergravity during parabolic~     flight.~   "
41245|NCT02517125|"~     Head and Neck cancers are treated either with surgical resection followed by adjuvant~     radiotherapy, or with organ preservation strategies using definitive radiotherapy with or~     without concomitant chemotherapy. These treatments have long-time functional side effects~     and consequences on the quality of life. Transoral robotic surgery has been developing since~     2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of~     the large surgical approach. The da Vinci device had the FDA approval and the CE mark in~     2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci.~     The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in~     april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery.~     The objective of our study is therefore to study the feasibility of this transoral robotic~     surgery for head and neck cancers, using the da Vinci Xi.~   "
41246|NCT02517112|"~     3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab~     D2 missions on a single astronaut. The results from this experiment have been published in~     the literature: the influence of respiration have been demonstrated and the signal~     processing methodology for the reconstruction of the displacement in one cardiac cycle have~     been developed. A 3D-BCG sensor has been developed and a collaboration to perform a~     sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To~     be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity~     before implemented on ISS.~      The aim of the present parabolic flight study is to serve as a feasibility demonstrator and~     test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to~     test whether the sensitivity of the developed 3D-BCG sensor is appropriate~   "
41247|NCT02517099|"~     This is a single-centre, randomised-controlled trial, comparing management of preschool~     wheeze. It specifically aims to compare management of preschool wheeze using current~     clinical guidelines to management determined by eosinophilic inflammation and infection.~     Participants will be children aged 1-5 years who have recurrent wheezing and will be~     allocated to one of two treatment groups, either current clinical care or pathological~     phenotype based management. They will be asked to make 2 study visits to the Royal Brompton~     Hospital over the course of 4 months.~   "
41251|NCT02517047|"~     Background: Pediatric asthma is the most common chronic illness among children and is~     associated with poor quality of life, activity restriction, school absences, and thousands~     of physician visits annually. The purpose of this study is to measure the effectiveness of~     using an innovative tracking system (CareTRx) for the self-management of asthma, including~     daily and rescue medication use, among children and adolescents with pediatric asthma.~   "
41252|NCT02517034|"~     This randomized clinical trial studies a geriatric assessment intervention in predicting~     chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer.~     Assessing patients' functional status, comorbidities, psychological state, social support,~     nutritional status, and cognitive function before treatment may help identify~     vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with~     cancer.~   "
41253|NCT02517021|"~     NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two~     antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate~     if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting~     after administration of repeated cycles of chemotherapy.~   "
41254|NCT02517008|"~     This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive~     (mama kit) on rural facility delivery rates in Zambia.~   "
41255|NCT02516995|"~     Merge the data of ultrasound with that of the anatomical and functional MRI is necessary~     since the high dose rate Curietherapy is carried out under ultrasound guidance. The~     investigators will recruit prostate cancer patients to evaluate the quality of the data,~     their sensitivity to exam conditions (patient position, volume of endorectal probe, gold~     grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from~     different sources with the purpose of estimating the opportunities of integration treatment~     plan for Curietherapy broadband.~      The nuclear magnetic resonance imaging provides precise anatomical study, but also provides~     access to a functional approach to the tumor mapping of water diffusion coefficient~     (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by~     spectroscopic imaging (IRMS). This multimodality imaging project is part of a~     multidisciplinary context, involving close collaboration between clinicians, medical~     physicists, and physicists of the teams participating in this project (Institut Gustave~     Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).~   "
41256|NCT02516982|"~     The aim of this study is to determine the feasibility of using mobile technology for:~        1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical~          management and service guidance NICE guideline for recognising depression (i.e.,~          Whooley questions followed by a validated screening instrument such as the Edinburgh~          Postnatal Depression Scale) during pregnancy using iPad Air tablets in the waiting area~          of general practices, midwifery services, or hospitals during antenatal clinics; and~        2. Using a bespoke app running on pregnant women's own smartphones to monitor mood and~          symptoms of depression throughout pregnancy.~   "
41257|NCT02516969|"~     Comparison of 1-year local control in patients with operable, recurrent~     previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.~   "
41258|NCT02516956|"~     This project aims to demonstrate that the best breakfast meal is the one able to improve the~     best postprandial hunger, satiety and adiposity regulators profile as well as the best~     reward-related gratification, due to hedonistic parameters. To do this, 4 different~     breakfasts will be tested and blood tests, food choices, and attentional components will be~     analysed.~   "
41259|NCT02516943|"~     Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive~     care unit (SICU). These luxury investigations waste the resources. Therefore we develop a~     pathological- based guideline for arterial blood gas analysis in patients after cardiac~     surgery. We test the guideline for its safety and efficacy.~   "
41260|NCT02516930|"~     This is a pragmatic, non-inferiority, randomized controlled trial comparing the~     effectiveness of two methods (crowdsourcing versus social marketing) for creating one-minute~     videos promoting condom use among MSM and TG in China. Crowdsourcing is the process of~     shifting individual tasks to a large group, often involving open contests and enabled~     through multisectoral partnerships.~   "
41261|NCT02516917|"~     This study aims to investigate the application of the Attention Training Technique in~     children with ADHD aged 7-11 years old. The research aims to investigate both the~     feasibility of this technique in this population as well as whether it can improve symptoms,~     behaviour and executive functioning.~   "
41262|NCT02516904|"~     A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of~     CD101 IV~   "
41263|NCT02516891|"~     The aims of this study are: 1) To identify more resistant the guidewire type to the~     retrieval maneuvers after the jailing.~      2) To determined anatomic and technical factors influencing the induced damage in the~     guidewire.~      Design of the study: prospective randomized study to compare 2 types of guidewire:~     hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation~     coronary lesions will be included. All of then will be treated by provisional side-branch~     stenting using the jailed wire technique. One hundred patients will be randomized to~     hydrophilic wires and another 100 patients to non-hydrophilic wires.~   "
41264|NCT02516878|"~     In this study, a 18-week, single-blinded, randomized controlled clinical trial will be~     conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight~     control in Hong Kong.~   "
41265|NCT02516865|"~     This project aims to test the feasibility of a practical physical activity intervention for~     postpartum women, incorporating the use of body weights worn during typical daily~     activities.~   "
41276|NCT02516722|"~     The objective of this study is to assess the safety, performance and initial effectiveness~     of the TIVUS™ System when used for pulmonary artery denervation through subjective and~     objective change in clinical parameters and haemodynamic evaluation. This is a prospective,~     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up~     to 5 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who~     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific~     medications.~   "
41277|NCT02516709|"~     Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.~   "
41384|NCT02515305|"~     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an~     FDA approved product for the treatment acne vulgaris~   "
41266|NCT02516852|"~     Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth~     and development. Yet, for poor children in developing countries, ASF consumption is limited~     by cost, inadequate caregiver knowledge, and lack of local production and physical~     availability. The impact of HH- and village-level livestock interventions on household~     dietary diversity and nutritional status in resource-poor communities is not well~     established. The objective of this study is to test the effectiveness of local egg~     production intervention on maternal and child diets and child nutrition status.~      This project takes place in the Luangwa Valley, Zambia in partnership with a local~     non-governmental organization, COMACO. Twenty communities will be assigned to the~     intervention, and 20 matched communities will be selected as controls. In each intervention~     community, an egg production facility will be built, owned, and operated by trained COMACO~     farmers. Simultaneously, a nutrition-focused behavior change campaign will be disseminated~     to all communities.~      Households (HHs) in each community will be sampled twice annually for 1 year~     pre-intervention (baseline) and 2 years post-intervention to assess dietary diversity and~     nutritional status. Data analysis will test for a change in these outcomes from baseline in~     each intervention community compared to the matched control community.~   "
41267|NCT02516839|"~     The objective of this proposed study is to collect initial efficacy data on ROC and ROC +~     BWL compared to an active comparator (AC) and to BWL.~   "
41268|NCT02516826|"~     1. Stains have demonstrated consistent benefits to reduce cardiovascular events in several~          primary and secondary prevention trials. The suppression of plaque progression or~          regression may be a part of mechanism of clinical benefit. The intravascular ultrasound~          studies demonstrated that intensive statin therapy can regress or inhibit the~          progression of coronary atherosclerosis.~        2. Unregulated renin-angiotensin system is important in the pathogenesis of cardiovascular~          disease. Angiotensin receptor antagonists (ARB) have been reported to improve clinical~          outcomes in patients with heart failure, left ventricular dysfunction, myocardial~          infarction, and high-risk patients. Several small studies showed that ARBs were~          effective to inhibit the progression of coronary atherosclerosis by intravascular~          ultrasound examination.~        3. The combined therapy with statins and ARBs may be additive or synergistic effects on~          the atherosclerosis regression as well as to improve endothelial dysfunction and~          insulin resistance in addition to lowering cholesterol levels and blood pressure when~          compared with either monotherapy in patients.~        4. Serial computed tomography angiography (CTA) can be utilized to assess the effect of~          treatment on coronary plaque morphology. In addition to the assessment of luminal~          stenosis, CTA also allows characterization of plaque morphology.~   "
41269|NCT02516813|"~     MSC2490484A or M3814 is an investigational drug that is being evaluated for the treatment of~     subjects with locally advanced tumors. The main purposes of this study are to determine the~     safety, the tolerability and the efficacy of MSC2490484A in combination with radiotherapy~     and in combination with chemoradiotherapy (Radiotherapy + cisplatin).~   "
41270|NCT02516800|"~     Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb),~     cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate~     concretions in the lungs as seen in Pulmonary Alveolar Microlithiasis (PAM). Extra pulmonary~     calcifications, including heart valve calcification, have previously been reported in~     patients with PAM.~      Calcific Aortic Valve Disease (CAVD) is a common disease in the elderly and is characterised~     by thickening and calcification of the aortic valve leaflets in the absence of rheumatic~     heart disease. CAVD is present in more than 25% of patients older than age 65 years and is~     associated with an increased risk of cardiovascular events. Currently, there is no effective~     therapy for the disease other than surgical aortic valve replacement. Both calcium and~     phosphate are the major components of calcific deposits in PAM and CAVD. Based on these~     preliminary findings, the investigators hypothesize that mutations in sodium phosphate~     co-transporters may play a role in both pulmonary and extra pulmonary calcifications.~      Two studies will be performed: 1. A retrospective cross-sectional study including patients~     with an age ≤ 65 years with CAVD from Denmark and Örebro, will be carried out. Genetic~     association analysis will be performed to investigate the incidence of common variants in~     five genes representing sodium phosphate co-transporters (SLC34A1, SLC34A2, SLC34A3,~     SLC20A1, SLC20A2) compared to healthy controls. Associated genes will subsequently be~     sequenced to identify possible causal mutations. 2. In a prospective study, aortic valve~     tissue will be collected from patients with AS undergoing surgical valve replacement.~     Molecular characterisation of the transporters will be conducted by determining the level of~     specific mRNA and protein by RT-PCR/qPCR, and Western Blotting, respectively. The~     localisation and visualisation will be investigated by immunostaining and confocal laser~     microscopy. Fibroblasts and endothelial cells will be isolated and grown in cultures with~     subsequent functional studies of the phosphate uptake.~   "
41271|NCT02516787|"~     Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or~     bone demineralization, extended stays in weightlessness also cause cognitive dysfunction.~     However, the studies on this subject during space missions short or long term could not~     determine how these cognitive dysfunction resulted from a direct effect of weightlessness or~     a stress-related effect.~      Analysis of electro-encephalography (EEG) using a standardized mapping method is used to~     study the changes of operation of the cerebral cortex as the near infrared spectroscopy~     (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a~     relatively simple and economical method for studying brain changes in an environment where~     the normal brain imaging techniques can not be used.~      The main objective of this experiment is to evaluate the alterations in brain cortical~     activity and brain oxygenation level induced by micro- and hypergravity conditions.~   "
41272|NCT02516774|"~     The hypothesis is that the particular richness of ATC's microenvironment in TAMs creates a~     unique opportunity for using Tumor Necrosis Factor blockade during chemotherapy and~     radiotherapy in order to counteract tumor resistance to therapy.~   "
41273|NCT02516761|"~     The idea of this study is the combination of these two techniques (low-impact aerobic~     exercise through functional movements and music therapy) that have proven to be effective~     separately. The main objective of this study is to test this combination to reduce~     widespread pain in fibromyalgia patients, improve their balance, influence on decreasing~     levels of depression and improve quality of life.~   "
41274|NCT02516748|"~     Accurate optical diagnosis of colorectal polyps could allow a resect and discard strategy~     with surveillance intervals determined based on the results of the optical biopsy. The~     investigators perform education to characterize the histology of diminutive and small~     colorectal polyps by using narrow band imaging (NBI). After education program, the~     investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by~     16 academic based gastroenterologists.~   "
41275|NCT02516735|"~     The purpose of this study is to assess whether i-scan with magnification can reduce the~     biopsy number needed per patient for the detection of gastric intestinal metaplasia without~     the loss of corresponding diagnostic yield.~   "
41278|NCT02516696|"~     This is a randomized, open-label, phase III study to investigate the efficacy of combination~     therapy with an induction phase utilizing a combination clarithromycin (Biaxin®),~     lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are~     newly diagnosed and require treatment when compared to patients who receive lenalidomide and~     dexamethasone alone.~   "
41279|NCT02516683|"~     Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported~     to be in the range of 5-30%, but limited number of long-term follow-up results.~      Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.~      Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees~     in Korea at 2001.~      Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by~     Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance~     Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched,~     non-infected 105 contemporary hospital employees.~      Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after~     outbreak.~   "
41280|NCT02516670|"~     This randomized phase II trial studies how well docetaxel works when given with or without~     ascorbic acid in treating patients with prostate cancer that has spread to other places in~     the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may~     help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better~     when given with or without ascorbic acid in treating prostate cancer.~   "
41281|NCT02516657|"~     The purpose of this study is to study the effect of a liraglutide, a glucagon-like peptide~     agonist, on post-meal blood glucose concentrations, glucagon levels, mean weekly blood~     sugars, and insulin doses in adolescents with Type 1 diabetes. Type 1 diabetes is an~     autoimmune disease that is usually diagnosed before the age of 20. Individuals with this~     disease are completely dependent on insulin for survival. While significant advances have~     been made in technological support for improving diabetes control, insulin remains the only~     effective treatment for Type 1 diabetes. Liraglutide is a long-acting glucagon-like~     peptide-1 analog. This drug is approved for the treatment of Type 2 diabetes in adults. This~     study will test the effect of liraglutide on blood sugar control in adolescents with Type 1~     diabetes.~   "
41282|NCT02516644|"~     The primary hypothesis of the investigators is that a virtual reality system combined with~     physical activity provided on a body weight support treadmill training would change clinical~     parameters of balance and mobility in people with Parkinson's Disease~   "
41283|NCT02516631|"~     The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol~     following single dose administration in adult women being given misoprostol for cervical~     ripening and induction of labour.~   "
41284|NCT02516618|"~     The primary objective of the study is to assess the safety and tolerability of a single dose~     of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese~     subjects.~   "
41285|NCT02516605|"~     A multi-part study to assess safety, tolerability and efficacy of LJN452 in patients with~     primary biliary cirrhosis~   "
41286|NCT02516592|"~     This study will investigate whether switching symptomatic COPD patients from a fixed-dose~     combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149~     110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect~     on symptom burden, breathlessness, and use of rescue medication after this switch.~   "
41287|NCT02516579|"~     In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA,~     to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in~     current practices for the prevention of symptomatic vaso-occlusive complications in patients~     with Sickle Cell Disease.~   "
41288|NCT02516566|"~     The investigators aim to investigate the effects of positive end-expiratory pressure~     ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in~     patients undergoing robot-assisted laparoscopic prostatectomy.~   "
41289|NCT02516553|"~     The aim of the phase Ia (dose escalation) part of this trial is to assess the MTD of BI~     894999 administered at escalating doses in two treatment schedules (schedule A of continuous~     dosing, schedule B with two weeks on treatment followed by one week off in 3-week cycles) in~     patients with solid tumours and for schedule A in Non-Hodgkin lymphoma patients. In the~     phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at~     the recommended dose and schedule in patients with solid tumours and to assess target~     modulation and the potential antitumour efficacy in patients with selected types of tumours.~     The PK profile will be determined from the first cycle in all patients in both phases.~   "
41290|NCT02516540|"~     The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a~     structured life-style intervention program with exercise training and mediterranean diet is~     effective regarding increased adherence to a mediterranean diet, reduction of body mass~     index, and increase of physical fitness.~   "
41291|NCT02516527|"~     The purpose of this study is to determine whether ipilimumab is effective in the treatment~     of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese~     subjects.~   "
41292|NCT02516514|"~     Current recommendations for the diagnosis of bacteremia based on the embodiment~     February-March blood cultures separated by a minimum interval of 30 minutes. Each blood~     culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10~     ml of blood. The sensitivity and specificity of this technique depends essentially on the~     amount of blood removed since there is a direct relationship between the volume of blood~     inoculated into each flask and the efficiency of the technique. A preliminary study~     conducted at the University Hospital of Caen found that 14-30% of patients depending on the~     services had received only one blood culture. In addition, at least four blood cultures in~     24 hours were taken for 10 to 20% of patients. The practice of a single blood culture~     reduces the sensitivity of the analysis due to insufficient total amount of blood collected.~     The practice of too many blood cultures increases the risk of false positive (presence of~     contaminating bacteria), generates extra work for healthcare personnel (and laboratory) and~     represents a significant cost for an unproven benefit.~      The investigators propose to evaluate a single blood culture sampling technique with seeding~     4 vials (2 aerobic and anaerobic 2).~   "
41293|NCT02516501|"~     Type of study: Pilot / phase I trial~      Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy~     (RCT) on body composition changes~      Trial Treatment Patients will be split into a control group and intervention group 1. If~     willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered~     into intervention group 2.~        -  Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast~          consisting of 50-250 ml betaquick® (vitaflo, Bad Homburg, Germany) and 5-15 g Master~          Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany).~        -  Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/day~        -  Control: No dietary intervention.~        -  All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine~          blood parameters and quality of life (QoL) questionnaire before, during and after RCT~      Endpoints~      Primary:~        -  Feasibility of the dietary intervention during RCT, measured by dropout rates~        -  Changes in body weight~        -  BIA phase angle and quantities derived from BIA variables~      Secondary:~        -  QoL~        -  Toxicities~        -  Blood parameters~        -  Grade of regression at time of surgery in case of rectum carcinomas~      Inclusion criteria~        -  One of the following tumor entities:~             -  Breast carcinoma~             -  Rectum carcinoma~             -  Head & Neck Cancer~        -  Histological confirmation of malignancy~        -  Signed written informed consent~        -  Karnofsky index ≥ 70~        -  Age between 18 and 75 years~        -  BMI between 18 and 34 kg/m^2~      Exclusion criteria~        -  Palliative patients, in particular with metastasis~        -  Type I diabetes~        -  Pregnancy~        -  Pacemaker and other metallic parts within the body~        -  Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or~          gluconeogenesis~        -  Unable to speak or understand German~        -  Cognitive impairments or psychological disorders~        -  Renal insufficiency~      Planned accrual~        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in~          intervention group 1~        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in~          control group~        -  Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ≥ 85 patients~      Study procedure~        1. Inclusion and full written informed consent.~        2. Baseline BIA measurement and blood work~        3. RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary~          intervention~        4. Final BIA measurement and blood work after radiotherapy~      Follow up For rectal carcinoma: Regression at time of surgery (c and p)~   "
41294|NCT02516488|"~     Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination~     against surgical histopathology of cystic pancreatic lesions.~   "
41295|NCT02516475|"~     To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory~     markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of~     Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg~     zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the~     investigators' diet . At the first and the end of the intervention,weight, body mass index~     (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin,~     hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.~   "
41296|NCT02516462|"~     Because a large proportion of the embryo's quality is dependent upon the egg, this~     investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In~     typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized.~     However, at this point the oocyte's quality has been set, and cannot be altered. Therefore,~     to have an impact on oocyte quality the use of in IVM is critical. Development of a~     successful IVM protocol for clinical use would not only provide an option for women of~     advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous~     gonadotropins used for stimulation, and significantly lessen the risk of ovarian~     hyper-stimulation.~      The objective of this research study is to evaluate a newly developed oocyte maturation~     media system for human clinical use in assisted reproductive technology (ART).~   "
41297|NCT02516449|"~     The purpose of this study is to determine whether the use of shared decision making aids is~     more effective than usual care in improving asthma knowledge, lessening decisional conflict,~     and enhancing adherence to treatments and asthma control in adult patients with mild to~     severe asthma.~   "
41298|NCT02516436|"~     A randomized, double blind, active controlled study in approximately 40 opioid dependent~     subjects. Study duration is up to five days and includes a maximum of 3 days confinement in~     the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria~     are eligible for enrollment into the study.~   "
41299|NCT02516423|"~     This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and~     zoledronic acid with zoledronic acid alone to see how well they work when given after~     radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Lenalidomide may help the immune system kill abnormal blood cells or cancer cells.~     Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic~     acid may prevent bone fractures and reduce bone pain, and may also improve survival.~     Standard treatment for this cancer is radiation therapy alone. It is not yet known whether~     ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone~     is more effective, and whether adding these treatments after radiation therapy is more~     effective than radiation therapy alone in treating patients with solitary plasmacytoma of~     bone.~   "
41300|NCT02516410|"~     Study to evaluate the efficacy of VX-661 in combination with ivacaftor through Week 12 in~     subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF~     transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not~     likely to respond to VX-661 and/or ivacaftor therapy (F508del/not responsive [NR]).~   "
41301|NCT02516397|"~     The purpose of this clinical trial is to evaluate the safety and efficacy of a food~     supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight~     subjects during 12 weeks treatment.~   "
41302|NCT02516384|"~     Inflammatory bowel disease is a condition caused by gastrointestinal immune system~     dysregulation and affected by both genetic and environmental factors. Differences in~     intestinal bacteria exist between IBD patients and healthy controls, but the role of~     intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal~     microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy~     donor to a patient with altered microbial diversity with the intent of restoring a normal~     bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an~     infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators~     hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively~     examine the safety of FMT in the management of ulcerative colitis (UC).~   "
41303|NCT02516371|"~     This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic~     correlations.~   "
41304|NCT02516358|"~     To quantify the local prevalence of diabetes mellitus in critically ill patients. To~     understand whether a correlation does exist between premorbid glycaemic control and~     glycaemic status in ICU. A subgroup analysis will be conducted to investigate whether a~     relationship does exist between Neuron Specific Enolase levels and glycaemic disorders.~   "
41306|NCT02516332|"~     Coronary heart disease (CHD) is the leading cause of death in the United States; more than~     600,000 Americans suffer a fatal cardiac event each year. Traditional CHD risk factors such~     as high blood pressure, smoking, and elevated cholesterol do not fully account for the~     timing and occurrence of CHD events and individuals with elevated levels of anxiety appear~     to have a greater risk of cardiovascular events. The present study will examine the impact~     of aerobic exercise and Lexapro in the treatment of anxiety and cardiovascular biomarkers~     among individuals with CHD.~   "
41307|NCT02516319|"~     The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function~     Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an~     adequate dose based on LFA technology and 3) determine an adequate time period for LFA~     determination.~   "
41308|NCT02516306|"~     The purpose of this study is to determine whether EV06 is safe and effective in improving~     distance-corrected near vision in people who have presbyopia.~   "
41309|NCT02516293|"~     Due to the lack of information in the literature about the role of cardiac rehabilitation on~     Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac~     exercise program on functional capacity, cardiac function, respiratory muscle strength, body~     composition, biomarkers and quality of life among Chagas heart failure patients.~   "
41310|NCT02516280|"~     A pilot study was performed to investigate the feasibility of a large randomized controlled~     trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in~     knee flexion range of motion in the first two days after total knee arthroplasty.~   "
41311|NCT02516267|"~     The purpose of this study is to assess platelet aggregability by a point of care device~     (Multiplate®) to decrease the release time for coronary artery bypass graft (CABG ) in~     patients with acute coronary syndrome (ACS) in use of dual antiplatelet therapy.~   "
41312|NCT02516254|"~     The aim of this study is to evaluate the efficacy of daily intake of fortified bread with~     vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy~     subjects compared to vitamin D supplement.~   "
41313|NCT02516241|"~     A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line~     MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care~     Chemotherapy in Patients with Stage IV Urothelial Cancer~   "
41314|NCT02516228|"~     This study examines the safety and feasibility of suppressing epileptic discharges through~     inducing long term depression of the epileptic focus with transcranial electrical~     neuromodulation.~   "
41315|NCT02516215|"~     This is an observational clinical study, patients with systemic diseases will be enrolled~     according to the inclusion and exclusion criteria. 360 patients will received the~     examination of sublingual microcirculation by using sidestream dark filed video microscope.~     The microcirculation data includes total small vessel density, perfused small vessel~     density, microvascular flow index, and heterogeneity index. The patients will be divided~     into right groups according to their systemic diseases as follows: group 1 hypertension (60~     patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60),~     group 4 end stage renal disease with hemodialysis (60), group 5 peripheral arterial~     occlusive disease (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30),~     and group 8 anemia (30).~   "
41316|NCT02516202|"~     This is a new application from the Menopause Strategies: Finding Lasting Answers for~     Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large~     multicenter trial comparing two common treatments, a vaginal hormone tablet and an~     over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms~     and sexual function, and to create a biorepository of specimens for future translational,~     mechanistic research on the etiology of vaginal symptoms.~   "
41317|NCT02516189|"~     The purpose of this study is to verify the effects of a strength training program on~     functional capacity, muscle performance and microcirculation in the elderly.~   "
41318|NCT02516176|"~     People who are living in the community following a stroke fall frequently. The ability to~     take a step in response to a balance disturbance helps to prevent falls but stroke survivors~     tend not to step with their paretic leg in these circumstances. This leaves them vulnerable~     to falls towards their paretic side. The purpose of this study is to train paretic limb~     stepping by having individuals stand sideways on a treadmill and respond to sudden~     accelerations of the treadmill.~   "
41319|NCT02516163|"~     This is a prospective, non-randomized, study of the clinical outcomes of participants that~     receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using~     ShapeMatch® Cutting Guides.~   "
41320|NCT02516150|"~     This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not~     significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with~     type 1 diabetes.~   "
41321|NCT02516137|"~     The purpose of this study is to find out if individuals with tight hamstring muscles who~     receive dry needling in addition to a standard stretching exercise program, show an~     improvement in hamstring tightness and function compared to individuals with tight~     hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to~     a standard stretching program.~   "
41322|NCT02516124|"~     The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem~     Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis~     (SSc) as currently performed by different study protocols used across Europe in various EBMT~     centres through the careful recording and analysis of routinely collected clinical and~     biological data.~   "
41323|NCT02516111|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2%~     atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony~     defects in patients with chronic periodontitis.~   "
41324|NCT02516098|"~     Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated~     tablets.~   "
41325|NCT02516085|"~     The purpose of the study is to show that the intake of L-arginine and metformin improves~     muscle function and delays disease progression in patients with Duchenne's muscular~     dystrophy.~   "
41326|NCT02516072|"~     With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is~     rising. With approximately one quarter of all PAD patients ultimately progressing to~     Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to~     accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be~     treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold~     standard of angiography.~      Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal~     impairment placing them at increased risk of developing contrast induced nephropathy (CIN)~     when exposed to iodinated contrast media. High risk individuals with decreased eGFR~     <60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and~     mortality risks with a greater need for dialysis and prolonged in patient hospital stays.~     Ideally, the investigators should be searching for ways to decrease the incidence of CIN.~     Animal studies and more recently pilot human trials have shown that subjecting a remote~     vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has~     been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against~     the development of CIN. This study aims to determine if RIPC can protect against CIN in~     patients undergoing elective peripheral angiography for infrainguinal disease.~   "
41327|NCT02516059|"~     Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder,~     catheterizable ileal pouch) is major abdominal surgery, which is associated with a high~     incidence of gastrointestinal complications.Perioperative techniques aiming at an early~     return of bowel function are to be pursued.~      Optimal postoperative pain management is one of the key factors leading to enhanced recovery~     after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is~     established, not only because of its excellent analgesic properties, but also because it can~     accelerate the return of bowel function. However, epidural analgesia is associated with~     additional costs, need for close monitoring and nursing. In addition each supplemental day~     with an indwelling epidural catheter increases the risk of infection. So it is recommended~     to re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner.~     Therefore, it is important to develop strategies that reduce its duration without impairing~     the benefits. Systemic analgesics with prolonged-release oral formulation like oral~     oxycodone (Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be~     a valuable alternative pain treatment as a second analgesic step, starting on postoperative~     day (POD) 3, so that the epidural catheter could be removed earlier without impairing~     postoperative enhanced recovery including return of the bowel function. Both oxycodone and~     naloxone orally administered are a recognized and accepted treatment option.~      The objective of this study is to evaluate the implementation of an oral opioid with or~     without naloxone in the early postoperative period in patients undergoing open radical~     cystectomy with urinary diversion and intraoperative and early postoperative use of epidural~     analgesia. The investigators expect an unchanged early return of the bowel function and~     equal analgesia with a reduced length of stay of the epidural catheter (primary endpoint),~     thus potentially reducing epidural catheter associated complications and lowering costs~     (nursing and pain service).~   "
41328|NCT02516046|"~     This study is designed to test the relationship between ante-mortem 18F-AV-1451 Positron~     Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with~     Alzheimer's disease (AD), as measured at autopsy.~   "
41329|NCT02516033|"~     Recently a combined approach of surgeon ablation in combination with endocardial ablation~     (hybrid ablation) has been introduced. This therapy has shown excellent results in patients~     with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in~     patients with persistent atrial fibrillation. The investigators hypothesize that the~     severity of atrial remodeling in patients with atrial fibrillation can be measured by~     clinical factors, echocardiographic parameters, circulating biomarkers and genetic~     background, and that these factors can be used to identify a risk profile to predict failure~     of the hybrid ablation therapy in patients with atrial fibrillation. Aim of this study is to~     determine a risk profile based on clinical correlates, circulating biomarkers, and genetic~     background associated with failure of the hybrid ablation procedure, in a prospective single~     center registry setting. The investigators evaluate all consecutive patients who have agreed~     to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators~     aim for a total of 250 participants. Extra study related procedures include blood sampling~     for biomarkers and genetic analysis, prolonged Holter monitoring for documentation of~     recurrences of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life~     questionnaire. Total follow-up will be five years.~      Main study endpoint is failure of the hybrid ablation procedure in patients with atrial~     fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia~     >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day~     Holter monitoring.~   "
41330|NCT02516020|"~     To compare the effectiveness of single step culture media and continuous uninterrupted~     culture media on blastulation rate~   "
41331|NCT02515994|"~     Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing~     study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared~     with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI~     investigational contact lenses on a daily wear basis.~   "
41332|NCT02515981|"~     The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health~     disparity and increased costs by providing incentivized health promotion programs to~     overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New~     Hampshire's 10 regional Community Mental Health Centers (CMHCs).~   "
41333|NCT02515968|"~     The purpose of this study is to investigate whether propofol can improve quality of recovery~     compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.~   "
41334|NCT02515955|"~     The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of~     JNJ-54175446 after multiple consecutive dose administrations~   "
41335|NCT02515942|"~     The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days)~     intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as~     compared to sham in subjects with geographic atrophy.~   "
41336|NCT02515929|"~     Aim: To evaluate the effectiveness on tissue response of the new nutritional supplement made~     of Oligomeric Proanthocyanidins (OPCs) in induced gingivitis after 21 days of use.~      Material and Methods: A double-blind randomized controlled prospective clinical trial was~     carried out on 20 patients divided into an experimental group treated with the OPCs pill and~     a control group treated with placebo, after fulfilling the selection criteria. Patients had~     to come 4 times during the study to register the Silness and Loe and Gingival Bleeding~     index, plaque index, inflammatory crevicular fluid study (IL6) and changes in brightness of~     the gingiva. No complementary hygiene methods were allowed during the 21 days.~   "
45813|NCT02457338|"~     The purpose of this study is to determine if supplementing healthy term infants delivered by~     C-section or vaginal delivery who only consume breastmilk with a probiotic for 21~     consecutive days increases levels of bacteria in infants' stool.~   "
41338|NCT02515903|"~     Views for surgery method selection of intracerebral hemorrhage are still controversial.~     Since the application of neuroendoscopic technique in intraventricular hemorrhage was~     confirmed effective and safe, some investigators have attempted to use endoscopic strategies~     to evacuate intracerebral hematomas. Some significant advances have also been reported in~     endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is~     still crucial to implement a prospective and controlled study to evaluate the efficiency and~     safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study,~     the investigators will exclusively select some patients with intracerebral hemorrhage in the~     basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery~     versus stereotactic aspiration on neurologic outcomes for patients with intracerebral~     hemorrhage.~   "
41339|NCT02515890|"~     The purpose of this study is to determine the effects of pain on facilitating long-term~     auditory memory in the presence and absence of two distinct intravenous anesthetics. The~     ability to identify previously presented words from a list will asses the degree of memory~     formation. In a subset of subjects, functional magnetic resonance imaging will be used to~     identify the neural correlates of memory inhibition or facilitation by the combination of~     pain and anesthetic used. The primary hypothesis is that pain will enhance memory formation,~     and that this will be mediated by additional neural pathways compared to those used to~     encode words not paired with pain. The study will occur over 4-5 visits and involves no~     long-term follow.~   "
41340|NCT02515877|"~     The treatment of cervical tumors depends on the stage of the disease. In advanced forms~     (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated~     with curietherapy , plays a major role. Until recently this association was the standard~     treatment for advanced stage uterine cancer. With this combination, rates of local failures~     (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 %~     for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO~     stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy~     allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous~     studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of~     the cervix. More than 19 randomized trials have been published. A meta-analysis of these~     trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The~     first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580~     patient, shows an improvement in survival, both in terms of progression free survival and~     overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p <~     0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were~     significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical~     benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally~     advanced, possibly due to small number of patients. The investigators have previously shown~     that antiviral agents used in preclinical models, Cidofovir® causes the selective~     radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to~     study a new concept to increase radiochemotherapy efficiency: the modulation of the~     expression of viral oncoproteins HPV virus by an antiviral agent.~   "
41341|NCT02515864|"~     A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval~     of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive~     Control, in Healthy Male and Female Volunteers.~   "
41342|NCT02515851|"~     For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius~     fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may~     decrease the need for post-operative narcotic pain medication.~   "
41343|NCT02515838|"~     A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Explore~     Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis~     (VOC) in Subjects with Sickle-Cell Disease (SCD).~   "
41344|NCT02515825|"~     The purpose of this non-significant risk study is to collect performance information~     regarding the use of the CADence system under normal conditions of use. This is a~     prospective, multi-center study to capture information on CADence agreement with coronary~     angiograms, on subjects who are already scheduled for coronary angiography.~   "
41345|NCT02515812|"~     Cardiological examination constitute one of the major directions in nuclear medicine for~     detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they~     constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or~     nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF~     stratification study based on cardiac adrenergic function after injection of a tracer:~     I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally~     in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous~     publications from 1992 to the present day have reported encouraging results for the daily~     use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest~     in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961~     patients. Typically, the camera used was an Anger camera with collimating Nai standard~     called parallel holes.~      The main objective is to validate the measurements of cardiac adrenergic function evaluated~     by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection~     of I-123-MIBG in 80 patients with heart failure.~   "
41346|NCT02515799|"~     The purpose of this study is to evaluate the mucolytic activity of Tacholiquine® compared to~     saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles~     in sputum and serum, and clinical symptoms by standardized questionnaires [COPD activity~     index (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)and the St.~     George's Respiratory Questionnaire (SGRQ)] will be evaluated in response to Tacholiquine®~     vs. saline in chronic bronchitis patients.~   "
41347|NCT02515786|"~     During normal breathing, the upper and lower airways performs the priming of inspired gas:~     humidification, heating and filtering from nose to the bronchios for adequate gas exchange~     occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions~     (cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced~     heart failure among others) may develop chronic respiratory failure and require treatment~     with oxygen therapy. High fractions of inspired oxygen have been associated with deleterious~     effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the~     patient with chronic respiratory receives oxygen via nasal cannula to the patient has been~     applied with and without humidification, however, does not know the effects of these two~     types of dry and humidified administration on the mucosa of the nose, airways and lungs. The~     investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7~     days 30 days, 12 months and 24 months.~   "
41614|NCT02512276|"~     The purpose of this cluster randomized controlled trial is to evaluate whether a novel~     tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and~     diabetes improves medication adherence, disease control, and patients' understanding of~     their treatment.~   "
41349|NCT02515760|"~     Non-small cell lung cancer is characterized by aggressive growth and treatment resistance.~     New approaches include immunotherapeutic strategies but spontaneous immune responses against~     tumor antigens remain unclear. The aim of this study is to characterize localization and~     frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated~     antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.~   "
41350|NCT02515747|"~     The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a)~     phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary~     disease patients divided on the basis of management strategy - medical, endovascular or open~     cardiac surgery.~   "
41351|NCT02515734|"~     This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus~     bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS~     wild-type tumors.~   "
41352|NCT02515721|"~     Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and~     gastric cancer are essential to improve patients' outcomes. This study aims to compare the~     diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based~     confocal laser endomicroscopy (pCLE) and iScan alone.~   "
41353|NCT02515708|"~     Normothermic machine perfusion (NMP) preservation is a promising method to decrease the~     complication of marginal donor livers compared to cold storage (CS). The aim of this project~     is to assess safety and feasibility of NMP in human liver transplantation. This will be a~     single center prospective cohort pilot study. Thirty-two livers with acceptable quality for~     transplantation will be preserved with NMP in 4-18 hours and transplanted. The follow-up~     period will be 6 months post-transplantation. The outcome will be compared to 128 historical~     patients transplanted in our program in the past 5 years (liver preserved using CS) with~     matched characteristics on age, Model for End-Stage Liver Disease (MELD) score, preservation~     time, etc.~   "
41354|NCT02515695|"~     Phase I study aiming at:~        -  assessing the absolute bioavailability, pharmacokinetic profile, and dose~          proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after~          i.v. and s.c. administration as well as the pharmacodynamic profile to create the link~          with available surrogate markers investigated with both formulations used clinically,~          lyophilisate with HSA (HSA+) and solution without HSA (HSA-);~        -  gathering further information on safety and tolerability of interferon beta-1a over~          dose range,including local and systemic tolerance, body temperature, vital signs, and a~          battery of exploratory sickness behavior tests.~   "
41355|NCT02515682|"~     We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among~     207 non-equol producing postmenopausal women with prehypertension to examine the~     effectiveness of equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function~     and other cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers)~     and explore the optimal dosage of equol.~   "
41356|NCT02515669|"~     The purpose of this study is to determine the safety and tolerability of BMS-986089 in boys~     with Duchenne Muscular Dystrophy with any genetic mutation.~   "
41357|NCT02515656|"~     POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated~     for the local treatment of vaginitis due to sensitive germs and treatment of non specific~     vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.~      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study~     supporting the interest of the combinaison of antifungal and antibiotics agents versus~     antifungal agent alone.~      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole~     in the treatment of women experiencing symptoms of infectious vaginitis.~   "
41358|NCT02515643|"~     Endothelial dysfunction one-year after transplantation mainly depends on~     transplant-associated factors and only marginally on reduced renal function.~      OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial~     dysfunction in two cohorts of patients, living kidney donors and their transplant~     recipients.~      Secondary objectives~      To evaluate in both cohorts of patients before and after nephrectomy/transplantation the~     evolution of the following parameters:~        1. Renal function (iohexolGFR, proteinuria/microalbuminuria).~        2. Blood pressure (24 h ambulatory blood pressure measurement)~        3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial~          index, pulse wave velocity).~      DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts:~     living kidney donors and their transplant recipients.~   "
41359|NCT02515630|"~     This study will evaluate the transfusion independence response rate in transfusion-dependent~     adults with myelofibrosis after treatment with momelotinib (MMB).~   "
41360|NCT02515617|"~     In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia~     (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last~     american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has~     been notified among the basic practices to prevent VAP. Nevertheless, the diffusion of SSD~     in ICUs remains limited. This situation is largely due to the initial overcost of the~     specific endotracheal tubes allowing SSD and to the unavailability of these devices in~     medical units in which patients are intubated before the ICU admission. So, this pragmatical~     cluster randomized and cross-over study evaluates the medico-economic impact of the~     subglottic secretions drainage in addition to VAP prevention bundles in ICU.~   "
41361|NCT02515604|"~     A randomised controlled trial assessing the efficacy of single versus repeated dose of~     vaginal misoprostol for the treatment of early pregnancy failure.~   "
41362|NCT02515591|"~     Validation study to use the disposable bronchoscopes in healthy volunteer research~     bronchoscopies to ensure adequate sample and cell yield.~   "
41363|NCT02515578|"~     Heart disease and strokes cause one in three deaths reported each year in the United States.~     Primary care practices need to implement new research findings that help decrease patients'~     risk for heart disease and stroke. This project will help to build primary care practice~     capacity for quality improvement and change management in small and medium size primary care~     practices in Colorado and New Mexico. This project will also help practices implement~     patient-centered outcomes research findings.~   "
41615|NCT02512263|"~     The purpose is to assess the adherence and the efficiency of a home-based training program~     on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety~     and depression for colon cancer patient treated by chemotherapy.~   "
41364|NCT02515565|"~     Acute respiratory infections are the fourth cause of hospitalization in elderly. Various~     studies have examined the impact of hospitalization in patients with respiratory pathology,~     showing the need of interventions in order to reduce the impact of hospitalization. The~     objective of this study is to examine whether a physical therapy intervention can reduce~     impairment in patients hospitalized due to pneumonia.~   "
41365|NCT02515552|"~     Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management~     strategies play a key role in reducing symptoms and maintaining functioning. The proposed~     project offers a web-based self management tool that enables FM sufferers to identify~     significant linkages between their personal symptom levels and their personal~     self-management efforts over time in order to plan their own optimal approach to disease~     management.~   "
41366|NCT02515539|"~     The purpose of the study is to generate early US feasibility data of the CardiAQ™~     Transcatheter Mitral Valve Implant System.~      The study will enroll patients with moderate to severe mitral valve regurgitation who are~     considered high risk for mortality and morbidity from conventional open-heart surgery.~   "
41367|NCT02515526|"~     Protocol title: Effect of acute alcohol consumption on the activity of major cytochrome P450~     enzymes, NAT2 and P-glycoprotein.~      Objectives: The study is mainly conducted to evaluate the effect of acute alcohol~     consumption on the activity of the most important drug metabolising cytochrome P450 enzymes~     CYP1A2, CYP2C9, CYP2C19, CYP2D6, intestinal CYP3A4, hepatic CYP3A4, NAT2 and on the activity~     of the drug transporter p-glycoprotein (intestinal and renal).~      The study should also provide basis for a planned clinical study on interactions caused by~     chronic alcohol intake.~      Design: Single center, open-label, two-way, cross-over study with randomly allocated~     sequences Test-Reference or Reference-Test.~      The study is not a clinical drug study according to the German Drug Act.~      Clinical phase: Not applicable~      Volunteers: 16 healthy male and female subjects are planned for completion in accordance~     with the protocol, i.e. with evaluable/analysable data for all periods and treatments.~      Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of~     Cologne, Gleueler Str. 24, 50931Köln, Germany~   "
41368|NCT02515513|"~     The relationship between myopenia, nutritional status, and long-term oncologic outcomes~     remains poorly characterized in patients with anatomically resectable pancreatic cancer~     (PC). The investigators want to look at muscle properties in pancreatic cancer patients to~     determine possible therapeutic options toward better nutritional status. Patients with~     benign right upper quadrant pathology will be utilized as controls for the study.~      The researchers hypothesize that improving cancer cachexia in PC will improve the quality of~     life and ultimately increase overall survival. The long term goal of is to identify areas of~     intervention to prevent and/or improve cachectic events in PC in order to significantly~     improve clinical outcomes. The first step in this long term goal is to fully characterize~     cachexia in the condition of PC. This research is to understand and modify the local~     response within skeletal muscle leading to a clinically relevant persistent wasting and to~     understand and interrupt the systemic stimulus produced by the tumor local environment~     resulting in these muscle specific mechanisms.~   "
41369|NCT02515500|"~     The study is designed to evaluate the efficacy of a cigarette reduction intervention using a~     novel device called the Quitbit, a digital lighter paired with a smartphone mobile~     application, to enhance self-regulatory techniques for reducing cigarettes smoked per day~     toward cessation.~   "
41370|NCT02515487|"~     The main goal of this project is to identify and remediate the cognitive difficulties,~     including processing speed and attention deficits in individuals who have undergone~     chemotherapy treatment. Recent research has demonstrated objective cognitive deficits~     following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as~     it was once considered. There are a large number of woman diagnosed and treated for breast~     cancer that experience chemotherapy induced cognitive deficits.~      Subjects who participate in the study will be evaluated for cognitive abilities prior to~     chemotherapy treatment and after completion of chemotherapy. Participants will then have the~     option to participate in the second phase of the study, which involves the use of a~     computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive~     evaluation.~   "
41371|NCT02515474|"~     Protection of Oddi's sphincter remains a huge argument especially in the long term~     complications like common bile duct stone recurrence or cholangitis after ERCP, which~     determined to destroy the sphincter of Oddi. The purpose of this study is to compare the~     long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.~   "
41372|NCT02515461|"~     The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can~     preserve kidney function in diabetic patients. Participants in this study will receive~     LE-SWT treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side~     effects. Previous studies have shown that LE-SWT induces angiogenesis. The investigators~     hypothesize that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains~     stable or increases in treated patients. Furthermore, kidney biopsy should show no signs of~     damage to the tissue and possibly neo-vascularization. In this project, the investigators~     shall also investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric~     oxide indices. Patients' self-reported quality of life will be assessed using Short Form 36~     version 2 (SF-36v2) Health Survey.~      There is an 18-months follow-up on patients. Only patients between 18-65 years old with~     moderate chronic kidney failure from diabetes will be included.~      This project is an interventional prospective study. 30 patients with moderate kidney~     failure will be recruited from the Department of Endocrinology, Odense University Hospital,~     Denmark. LE-SWT treatment will be performed in the ambulatory of Department of Urology.~     Patients will be hospitalized for 1 day in the Department of Nephrology when kidney biopsy~     is taken (two times in study period).~   "
41448|NCT02513771|"~     The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for~     sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and~     women when compared to a placebo (inactive medication like a dummy pill). The study will~     evaluate whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and~     effective for HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes.~     Sitagliptin is a medication that is used to treat people with diabetes (high blood sugar)~     but also may reduce inflammation in the body.~   "
41373|NCT02515448|"~     Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection~     associated with the highest morbidity and mortality.~      Respiratory infection with resistant organism are increasing in prevalence. Because of lack~     of alternatives, amino glycoside, old antibiotics family, can be used for several infection.~      Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for~     respiratory infections. Gentamicin,which is effective against numerous multi drug resistant~     Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option~     for nebulisation.~      The investigators assume that nebulisation of gentamicin allows to obtain a higher lung~     concentration while assuring a systematic toxicity much lesser than a parenteral~     administration.~   "
41374|NCT02515435|"~     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer~     treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which~     selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also~     represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally~     bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial~     cell migration and proliferation thus blocking blood vessel formation in tumor tissues.~     Previous studies have identified that apatinib was well tolerated at doses below 750mg~     daily. In phase I/II study, investigators reported an objective response rate of 80% in 65~     cancer patients. In a phase III trial conducted in advanced pretreated gastric cancer, the~     median overall survival was significantly prolonged in the apatinib group compared with~     placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and~     safety of apatinib in heavily pretreated advanced non-squamous non-small cell lung cancer.~   "
41375|NCT02515422|"~     Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone~     or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative~     pain scores and opioid consumption.~      Methods: Included patients were allocated to four treatment groups using computer-generated~     randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous~     infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of~     bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of~     ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of~     placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and~     nursing staff were blinded to the contents of the medications. VAS scores at resting and on~     coughing and analgesic consumptions were compared.~   "
41376|NCT02515409|"~     The purpose of this study is to determine whether heated humidified high flow nasal cannula~     (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to~     continues positive airway pressure (CPAP) treatments in children and to compare their~     adherence and compliance.~   "
41377|NCT02515396|"~     A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the~     effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory~     markers.~   "
41378|NCT02515383|"~     The goal of this research study is to learn if a symptom questionnaire used for adults at MD~     Anderson can be improved to better understand the symptoms experienced by 13-17 year old~     patients with cancer.~   "
41379|NCT02515370|"~     The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT~     Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an~     enhanced group peer support intervention called friends for life circles.~   "
41380|NCT02515357|"~     Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent episodes of~     partial or complete collapse of the upper airway during sleep, leading to pauses of~     breathing and arousals. Although previously considered as a local abnormality of the~     respiratory track, it is nowadays recognized as a systemic disease and an important cause of~     morbidity and mortality, since it is strongly associated with obesity (especially abdominal~     obesity) and cardiometabolic diseases, including the metabolic syndrome, cardiovascular~     diseases and diabetes mellitus. The modification of lifestyle habits, e.g. in terms of diet~     and physical activity, is currently explored as a mean of managing the disease in~     combination with the first line treatment, i.e., the application of continuous positive~     airway pressure (CPAP) during sleep. The available data support that weight loss, achieved~     through lifestyle modification, effectively reduces the severity of OSA and improves the~     associated cardiometabolic disorders in overweight or obese patients. However, studies~     exploring the potential effect of diet's quality or other lifestyle habits (such as physical~     activity) on OSA severity, besides weight loss, are currently lacking. Given that a~     Mediterranean dietary pattern as well as other lifestyle habits adopted by the populations~     in the Mediterranean region have been proven beneficial both for the prevention and the~     resolution of the metabolic syndrome and its associated cardiometabolic diseases, the aim of~     the present randomized, controlled, single-blind study is to implement an intensive 6-month~     intervention based on the Mediterranean lifestyle (hypocaloric diet and 7 group lifestyle~     counselling sessions) and to evaluate its potential benefits, compared with standard care~     (hypocaloric diet and written advice for healthy lifestyle), in a sample of patients with~     OSA.~   "
41381|NCT02515344|"~     Objective : to demonstrate that providing to GPs a list of their patients who are not~     compliant to colorectal cancer screening will 1) enhance patient participation to screening,~     and 2) decrease the proportion of cancer diagnosed outside the screening organisation.~     Design : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3~     groups of the study will be all GPs 1) from the Loire-Atlantique and Vendée geographic~     area (1300 GPs on average) and 2) who have more than 100 patients in their patient list~     (based on data provided by the Healthcare Insurance System Services). Patients will be~     eligible to the study depending on their eligibility to the Faecal Occult Blood Test for~     colorectal cancer screening : 1) they should be older than 50 and younger than 74; 2) they~     should not have a personal history of colorectal cancer (or history of adenoma bigger than 1~     cm) nor a family history of colorectal cancer. Main outcomes measures : Patient~     participation to colorectal cancer screening, and number of cancers screened in (versus~     diagnosed outside) the screening procedure.~   "
41382|NCT02515331|"~     The purpose of the present study is to determine whether LHW090 displays the clinical safety~     and efficacy profile to support further development in patients with resistant hypertension.~   "
41383|NCT02515318|"~     Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of~     disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an~     acute event characterized by a worsening of the patient's respiratory symptoms that requires~     a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year).~     It increases in frequency with the severity of the disease. The objective of this study is~     to examine whether a physical therapy intervention can reduce impairment in patients with~     COPD during hospitalization due to an acute exacerbation.~   "
41385|NCT02515292|"~     Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and~     immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of~     neonates with intrauterine growth restriction (IUGR) and the integration in a~     multidimensional statistical model .~      Objectives:~        1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor~          gene expression in cord blood from newborns with intrauterine growth restriction~          (IUGR). (Prospective)~        2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and~          paraclinical. (Retrospective & prospective)~        3. Evaluation and monitoring of morphological and functional by echocardiography.~          (Prospective)~        4. Integrating multidimensional clinical and paraclinical parameters in a statistical~          model for evaluating newborn with intrauterine growth restriction.~   "
41386|NCT02515279|"~     This noninterventional, open-label study will observe the safety and tolerability of~     peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for~     HCV infection according to routine practice.~   "
41387|NCT02515266|"~     Postnatal growth is a crucial in premature infants as it could be correlated with the~     long-term cognitive development. Optimal nutritional care is required to reduce the initial~     weight loss and further growth deficit.~      The quantitative objective is to achieve growth that is at least equivalent to that of the~     fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often~     grow during difficult 10-15 first days of life, so they accumulate a delay that should~     compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than~     15 g/kg.day.~      Individualized fortification of human milk (HM) has been proposed to optimize postnatal~     growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal~     growth in preterm infants.~      The objectives of this study are to determine the effectiveness of additional protein~     fortification (APF) in terms of short-term growth along with the proportion of extremely low~     birth weight (ELBW) infants requiring APF.~   "
41388|NCT02515253|"~     The purpose of this study is to assess whether prescribing a bra to participants results in~     an improvement in the Patient Global Impression of Change (PGIC) compared to participants~     who receive standard care alone.~   "
41389|NCT02515240|"~     The purpose of the study. To characterize the immune response to the pneumococcal vaccine in~     HIV positive individuals and to dissect the most appropriate timing and frequency of~     vaccination.~   "
41390|NCT02515227|"~     This study evaluates whether it is safe to administer a peptide vaccine in combination with~     pembrolizumab. This study will also evaluate the effects of the combination of the peptide~     vaccine and pembrolizumab on the immune system. The investigators will monitor these effects~     by performing tests in the laboratory on participants' blood, a lymph node, and tumor~     samples.~   "
41391|NCT02515214|"~     The use of bariatric surgery has risen subsequently over the last decade, especially in~     women of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of~     e.g. an increased fertility (because of the weight loss) and a possible ineffectiveness of~     contraceptives (because of a malabsorption in the intestine). Although a pregnancy after~     bariatric surgery is generally known as safe, there are a few studies that indicate that a~     pregnancy after a bariatric surgery is not always without complications, and that it should~     be considered as a high risk pregnancy. The research on pregnancy outcomes after this type~     of surgery is rather limited to a few small, mainly retrospective, observational~     case-control and cohort studies and a limited amount of case studies. For risk- and prognose~     related issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy,~     development of complications during the pregnancy and pregnancy outcomes, large prospective~     cohort studies are needed. Besides, breast feeding practices and breast milk composition~     have scarcely been investigated in this population. The energy content of breast milk could~     possibly be influenced by a state of malabsorption after the procedure. Low amounts of~     vitamin B12 have also been noticed in the breast milk of women the surgery. The overall~     objective of this study is to establish a group of women at reproductive age (age 18-45)~     with a history of bariatric surgery and to generate an extensive database for future~     analysis. The final goal of the researchers is to develop guidelines or recommendations on~     how to manage pregnancies after bariatric surgery, based on large-scale prospective~     research.~      The study design is a multicentric observational and prospective cohort study. Participants~     will be followed from the moment of surgery until 6 months postpartum and they can be~     included on several time points (before surgery, after surgery (<12 months); after surgery~     (>12 months) or during the pregnancy). Both retrospective and prospective data concerning~     the medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical~     activities, smoking, sleeping), blood samples, psychological factors (fear and depression),~     sexuality, quality of life and pregnancy outcomes will be collected. Data collection by the~     investigators will happen in a web-based database and by direct online registration by the~     subjects.~   "
41392|NCT02515201|"~     Clinical trial, that aim is evaluation of the use of taurolidine and heparin in the~     prevention of bloodstream infection in venous catheter in children with intestinal failure.~   "
41393|NCT02515188|"~     Sedation for catheter ablation of atrial fibrillation should be performed to achieve~     analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as~     propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However,~     propofol and midazolam causes respiratory depression and dexmedetomidine occasionally~     accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that~     does not induce respiratory depression with stable hemodynamics is needed.~      Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and~     1st line drug for fever and pain. In a previous study, paracetamol reduced morphine~     consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the~     investigators hypothesized that addition of propacetamol to previously used sedatives~     midazolam-remifentanil will reduce opioid consumption during the catheter ablation.~      Therefore, the investigators designed this study to investigate the role of addition of~     propacetamol to previous used midazolam-remifentanil sedation. This study will compare the~     opioid consumption and respiratory effect of propacetamol with placebo-control for catheter~     ablation of atrial fibrillation.~   "
41394|NCT02515175|"~     This study evaluates the reduction in viral shedding after vaccination with a new~     formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the~     participants will receive GEN-003, one-third will receive placebo.~   "
41395|NCT02515162|"~     In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia,~     two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision~     Procedure, will be compared. The primary outcome of the study is dysplasia-free resection~     margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis,~     intervention time, postoperative pain, intra- and postoperative complications, the resected~     cone volume and users satisfaction.~   "
41396|NCT02515149|"~     Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost~     Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and~     Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western~     Kenya.~   "
41397|NCT02515136|"~     In a computerized experiment, visual stimuli will be presented to the parkinson's disease~     patients and to the controls. They will respond to each image by acting on the keyboard in a~     specific manner. Each participant will repeat that task 384 times per session. A break will~     be inserted every 12 tests so that participants can rest.~      The experiment consists of three sessions. Each image will be presented three times. For the~     first two presentations it is assumed that a link will be created between the image and the~     task, and the image and action. In the third presentation, the same task and the same action~     will be maintained or will be swapped. In this way, It can be checked whether associations~     thus generated will affect the performance of the participants when tasks and actions will~     be incongruent.~   "
41398|NCT02515123|"~     Early enteral feeding is a key component of the management of critically ill patients~     receiving mechanical ventilation. However, enteral feeding has been associated with serious~     complications such as gastro-esophageal reflux, with both overt and micro pulmonary~     aspiration, which potentially increases the risk to nosocomial pneumonia. Many critically~     ill patients experience poor tolerance of early enteral nutrition because of impaired~     gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric~     volume, gastro esophageal reflux, vomiting, aspiration, and VAP. Early and adequate enteral~     feeding in ICU patients is correlated with decreased overall infections rates, ventilator~     and intensive care unit (ICU) days, costs, and mortality.~      This study is intended to assess the efficacy and safety of the E-Motion System (i.e.~     E-Motion tubeTM and E-Motion EPG 1000TM) in improving tolerance to enteral nutrition by~     inducing esophageal motion by means of electrical stimulation in ICU patients.~   "
41399|NCT02515110|"~     Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional~     nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment~     groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam~     radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3)~     plans for locoregional EBRT following mastectomy with reconstruction.~      Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other~     EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with~     reconstruction, cosmetic outcome.~   "
41400|NCT02515097|"~     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult~     subjects with moderate to severe plaque psoriasis.~   "
41401|NCT02515084|"~     The purpose of the study is to evaluate the concordance between the 18F-PET/CT under~     thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the~     detection of residual mass in 40 patients with partial response or relapsed differentiated~     thyroid carcinoma.~   "
41402|NCT02515071|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic~     blood pressure in multiple populations as well as increase organ perfusion in areas of~     interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is~     associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of~     dietary nitrate in OSAS has not been reported.~   "
41403|NCT02515058|"~     The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to~     examine histologic wound healing following ridge preservation using bone allograft that has~     been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire~     protocol involves procedures that are standard care. All materials are FDA-approved~     materials being used in an FDA-approved manner. The test group subjects will have extraction~     sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This~     test group will be compared to an active control group using cancellous freeze-dried bone~     allograft (called FDBA). The null hypothesis is that there will be no significant difference~     in formation of new vital bone between treatment groups (primary outcome).~      Each subject will provide a single non-molar tooth site for study treatment. After tooth~     extraction, the graft material will be placed and covered by a resorbable collagen membrane.~     Following 3 months of healing, the dental implant will be place, at which time a core of~     bone will be removed from the site as part of the preparation for the implant. The core~     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation~     and secondary histologic outcome of % residual graft material.~   "
41404|NCT02515045|"~     To compare the use of an injectable compound containing an antibiotic and an~     anti-inflammatory at time of cataract surgery to standard of care that is the use 3~     different topical medications to prevent inflammation and infection after routine cataract~     surgery.~   "
41405|NCT02515032|"~     SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary~     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main~     objective is to study the safety and tolerability of Nutrifriend Cachexia.~   "
41406|NCT02515019|"~     Electroencephalographic-based monitoring systems such as the bispectral index (BIS) may~     reduce anaesthetic overdose rates. The investigators hypothesised that goal-directed~     sevoflurane administration (guided by BIS monitoring) could reduce the sevoflurane plasma~     concentration (SPC) and intraoperative vasopressor doses during on-pump cardiac surgery in a~     prospective, controlled, sequential two-arm clinical study.~   "
41407|NCT02515006|"~     Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom~     satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective~     intervention may offer a practicable solution. The aim of this study was to investigate the~     clinical effectiveness of homeopathy for insomnia.~   "
41408|NCT02514993|"~     -  Analysis of patient data and computed tomography scan of polytraumatized patients~          thoracic spine fractures~        -  A concomitant sternal fracture was identified an indicator for an unstable thoracic~          spine fracture~   "
41409|NCT02514980|"~     this study will be undertaken to evaluate the safety and analgesic efficacy of adding~     ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain~     postoperatively following repair of cleft lip in children less than two years of age.~   "
41410|NCT02514967|"~     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by~     a composite responder index in subjects who, despite corticosteroid use, continue to have~     seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by~     SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or~     C4).~   "
41411|NCT02514954|"~     Each subject will be randomly allocated to a sequence of two treatments applied at two~     separate dosing visits. At each dosing visit subjects will be injected with individualised~     doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a~     standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at~     both dosing visits of one individual and will be administered subcutaneously in the~     abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for~     dinner at home in the evening before each dosing visit. Subjects will attend the clinical~     site in a fasted state in the morning of each dosing day and stay at the clinical trial~     centre until 10-hour after dosing (standardised test-meal procedure has been terminated~     after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.~   "
41412|NCT02514941|"~     The purpose of this study is to evaluate pharmacokinetics of paracetamol, amoxicillin and~     talinolol in morbid adipose subjects before as well as shortly after and about one year~     after proximal Roux-en-Y Gastric Bypass (RYGB) and to measure messenger ribonucleic acid~     (mRNA) expression and protein content of duodenal and/or jejunal drug metabolizing enzymes~     (eg. cytochrome P450 isoenzyme 3A4 (CYP3A4), uridine diphosphoglucuronosyltransferase~     (UGTs)) and drug transport proteins (e.g. P-glycoprotein, MRP2, OATPB, PEPT) before and~     during the operation and about one year after proximal RYGB.~   "
41413|NCT02514928|"~     This study is performed to confirm whether resection of the nerve plexus on the right half~     of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and~     relieve pain of pancreatic cancer patients.~   "
41414|NCT02514915|"~     The primary goal of this research study is to determine the efficacy of giving pre-operative~     radiosurgery to patients pending resection of a brain metastasis.~   "
41415|NCT02514902|"~     In the search for a novel marker of stroke that could be rapidly assessed in blood, the~     investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15~     min) detects levels of a biomarker that is released into blood following neuronal injury~     associated with stroke and traumatic brain injury. The protein's expression in human brain~     should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.~   "
41416|NCT02514889|"~     Investigators from the University of California-Los Angeles (UCLA) and The Children's Clinic~     of Long Beach (TCC) are conducting a randomized, controlled comparative effectiveness trial~     of two government-sanctioned behavior change approaches to weight control with TCC's obese~     patients. The first approach is the calorie-counting calorie restriction (CC) approach used~     in the Diabetes Prevention Program. The second approach is the high-satiation/high-satiety~     approach represented by MyPlate.gov. The MyPlate nutritional goal is to double patient fruit~     and vegetable intake, legume intake, and whole grain intake. Both conditions stipulate 150~     minutes of moderate physical activity a week. Study participants will be 300 of TCC's obese~     patients, 75% of whom are expected to be Latino, 15% African American and 10% Other~     Ethnicities.~      The interventions will be implemented by trained community lifestyle change coaches with~     brief support from clinicians. The interventions will include two home visits, two group~     education sessions and seven telephone behavior change coaching sessions.~      Compared to the CC approach, the MyPlate approach is hypothesized to yield better 12 months~     patient-centered outcomes, particularly self-reported satiety.~   "
41417|NCT02514876|"~     This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac~     Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation~     procedures.~   "
41418|NCT02514863|"~     Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing~     diverging results. With electrode position being a suspected factor influencing measurement~     accuracy or reproducibility for impedance cardiography in general, no data is currently~     available on altering the gap of the two lower electrodes in EV. Reference values were~     determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).~   "
41419|NCT02514850|"~     This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period~     cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin~     treatment. Each subject will be randomly allocated to a treatment sequence and will be~     administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog®~     Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus®~     during three separate dosing visits.~   "
41420|NCT02514837|"~     A malignant tumor has higher temperature than normal tissue and the temperature of the tumor~     is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of~     tumor activity.~      The temperature changes begin in the stage of atypical hyperplasia and increased~     proliferation and this opens up the possibilities for detection of patients with high risk~     lesions.~      Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal~     tissue at the depth of several centimetre and allows visualization of the temperature on the~     thermogram and temperature field.~      It is noninvasive and the measurement of internal temperature is based on receiving natural~     electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device~     is absolutely harmless and has no risk because it does not emit any radiation. It can be~     used repeatedly as a method of monitoring.~      Microwave radiometry has successfully completed seven clinical trials of more than 1000~     patients in different countries. Microwave device (RTM-01-RES) is used in more than 300~     medical centers in 30 countries.~      Medical technology of microwave radiometry is included in the nomenclature of medical~     services in the Russian Federation, the Ministry of Health and is part of the standard of~     care for patients with malignant tumors of the breast.~      This method of microwave radiometry is recommended by leading Russian mammalogists in the~     National guidelines of breast care.~      The investigators would like to use the device in clinics in Scotland and later United~     Kingdom (UK) for breast diagnosis and monitoring treatment.~      During 3 months the investigators aim to examine 150 patients with breast cancer and 150~     patients without cancer who will be the control group. The results of temperature~     measurement will be compared with the results of histology, in particular, tumour cellulants~     p53 expression and other gene expression data for metabolic biomarkers and other tumor~     indicator. Statistical analysis of data will be performed. The device and initial training~     will be provided by RES Company (device producer).~   "
41421|NCT02514824|"~     This research study is studying a targeted therapy as a possible treatment for merkel cell~     carcinoma.~      - The name of the study intervention involved in this study is: MLN0128.~   "
41422|NCT02514811|"~     The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program~     (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon,~     and Washington. The purpose of this study is to measure: at the end of the program year,~     were TOP students less likely than control group students to report ever being pregnant or~     causing someone to be pregnant?~   "
41449|NCT02513758|"~     Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial~     cells, Langerhans cells) and antibodies may also play a critical role. The investigators'~     study aims to precise the role of each type of cells, the interaction cell-cell and~     cell-antibodies.~   "
41423|NCT02514798|"~     Patients affected with severe parenchymal pulmonary diseases, such as Chronic Obstructive~     Pulmonary Disease (COPD ), may experience dyspnea at rest due to increased work of breathing~     and reduced oxygenation. The delivery of high-flow humidified nasal oxygen (HFNC) has been~     shown to have a positive-end-expiratory pressure (PEEP) effect and is able to flush out CO2~     from the upper airways, reducing dead space ventilation. Furthermore it has been proven to~     reduce the respiratory rate shortly after its initiation. These multiple actions offer the~     potential of changing the respiratory pattern and reducing work of breathing, improving the~     efficiency of breathing.~      In this short-term, physiological, open, randomized, cross-over pilot study the investigator~     swill describe the effects of varying settings of high-flow nasal oxygen on respiratory~     rate, tidal volume, and diaphragmatic work of breathing in patients with severe COPD. The~     investigators will also describe changes in gas exchange and effects on the subjects'~     comfort and dyspnea and the breathing responses to varying setting of CPAP in the subject~     population.~   "
41424|NCT02514772|"~     The study objective is to identify potential safety risks of the transition from US-licensed~     Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to~     continuous treatment with the originator product in terms of general safety and~     immunogenicity.~   "
41425|NCT02514759|"~     The Women's Clinic of Kansas City (TWC) replicated the Teen Outreach Program (TOP) across~     Kansas City, Missouri. The purpose of this study is to measure: one year after the end of~     the program year, what is TOP's impact on the treatment group's sexual activity and~     contraceptive use, relative to the control group, at one year following the program?~   "
41426|NCT02514746|"~     This study aims to understand the persistence of the Japanese encephalitis (JE) antibody~     response in previously vaccinated children. The proposed study is a phase 4 open-label trial~     enrolling up to 818 Bangladeshi children who had previously participated in a lot to lot~     consistency study (JEV05) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).~   "
41427|NCT02514733|"~     This is a single center study that seeks to study the impact of donor age on recipient~     outcomes in older kidney transplant recipients.~   "
41428|NCT02514720|"~     The purpose of this study is to investigate the effects of nicotine metabolism on occupancy~     of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence~     and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study~     and the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl-~     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.~   "
41429|NCT02514707|"~     Study Title: Outcomes of HIV infected individuals after ten years on antiretroviral~     treatment Short Title/Study ID: ALT cohort Protocol Version and Date: Version 1.0 June 2013~     Clinical Phase: NA Methodology: Prospective observational study Study Duration: 01 January~     2014- 30th June 2025 Study Centre(s): Single centre (Infectious Diseases Institute, Kampala,~     Uganda) Number of Subjects: Enrollment of 1,000 study participants. All patients discharged~     from the IDI Research cohort (10 years of follow up on ART) will be offered to participate~     in the study. Additional patients with similar characteristics will be enrolled from he~     clinic Diagnosis and Main Inclusion Criteria: HIV patients above 18 years and in their 10th~     year of ART Main Exclusion Criteria: ART started outside IDI Study Product, Dose, Route,~     Regimen: ART will be provided according to standard of care at IDI and according to the WHO~     and Ugandan guidelines Duration of follow up: 10 years Reference therapy, Dose, Route,~     Regimen: Not applicable Recruitment Schedule: 1 January 2014- 30 June 2015 Statistical~     Methodology: Time to event analysis (end of treatment, failure, death, switch, occurrence of~     drug toxicities) including Kaplan-Meier curves and Cox regression will be performed.~     Endpoints will be correlated with characteristics at ART start and at study enrollment.~     Possible confounding variables, if available, will be considered.~      GCP Statement: This study will be conducted in compliance with the protocol, the current~     version of the Declaration of Helsinki, and ICH-GCP as well as all national legal and~     regulatory requirements.~   "
41430|NCT02514694|"~     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma~     A/S (the Sponsor) for treatment of psoriasis. The aim (s) of this Study are to determine:~        -  The safety and tolerability of the Study Drug and any side effects that might be~          associated with it~        -  The Study will also measure how much of the Study Drug that gets into the blood and how~          long time it takes for the body to remove it.~   "
41431|NCT02514681|"~     The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab~     and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in~     locally advanced or metastatic breast cancer patients for previously treated with pertuzumab~   "
41432|NCT02514668|"~     Primary Objective:~        -  Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with~          relapsed/refractory multiple myeloma (RRMM).~        -  Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall~          response rate (ORR) in RRMM patients previously treated with daratumumab~      Secondary Objectives:~        -  Part A:~        -  To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.~        -  Part B:~        -  To evaluate the safety of SAR650984 (isatuximab).~        -  To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response~          (DOR), clinical benefit rate (CBR) and progression free survival (PFS) .~        -  To assess the pharmacokinetics (PK) of SAR650984 (isatuximab).~        -  To evaluate the immunogenicity of SAR650984 (isatuximab).~   "
41433|NCT02514655|"~     Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes~     excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP)~     and early tracheal lesions resulting from intubation with decreased discomfort, morbidity,~     and nursing workload.~      The main objective of the investigators is to show that Nosten® device is more effective~     than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP~     occurrence.~   "
41473|NCT02514304|"~     The purpose of this multicenter, two component observational and standardized case-control~     study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective~     3-month and 12-month follow-up to examine outcomes and their possible causes.~   "
41474|NCT02514291|"~     The purpose of the study is to develop and evaluate a sleep intervention program for~     improving sleep and health in youth with epilepsy and their parents.~   "
41434|NCT02514642|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)~     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to~     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment~     elevation. However, few East Asian patients (or those of East Asian descent) have been~     included in these trials to assess the use of these drugs. In Korea and Japan, it has been~     reported that low doses of ticagrelor might have a more potent inhibition of platelet~     aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with~     stable coronary artery disease, respectively. But it is still not clear whether a low dose~     of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A~     recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum~     plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg~     twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher~     in healthy Chinese volunteers compared with Caucasian subjects. This data also suggested~     that a low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of~     a large diurnal variation with a single daily dose, a lower dose twice daily may be a better~     choice for Chinese patients. Therefore, the investigators performed this randomized,~     single-blind, crossover clinical trial to observe the efficacy and safety of low-dose~     ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese~     patients with stable coronary artery disease.~   "
41435|NCT02514629|"~     The purpose of this study is to examine the effects of metformin, testosterone, or both, in~     males with obesity-related hypogonadism. This study will evaluate changes in insulin~     resistance, weight loss, body composition, testosterone levels,quality of life and erectile~     dysfunction.~      Obese men will receive diet and physical activity counselling, and be randomised to either~     testosterone, metformin, a combination of both or placebo~   "
41436|NCT02514616|"~     The investigational device that will be used in this trial is the EndoStim® Lower Esophageal~     Sphincter (LES) Stimulation System.~      The purpose of this trial is to evaluate the safety and the effectiveness of electrical~     stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of~     subjects with gastroesophageal reflux disease (GERD).~      The study population will consist of subjects diagnosed with pathological GERD as defined by~     abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily~     PPI use.~   "
41437|NCT02514603|"~     The primary purpose of this study is to assess the tolerability of prexasertib in Japanese~     participants with advanced solid cancers.~   "
41438|NCT02514590|"~     The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord~     Stimulator (SCS) System for treatment of chronic pain utilizing high frequency (10,000 Hz)~     waveforms in comparison to traditional stimulation settings.~   "
41439|NCT02514577|"~     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult~     subjects with moderate to severe plaque psoriasis.~   "
41440|NCT02514564|"~     This study evaluates the effects of different volumes of aerobic exercise training in~     cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac~     rehabilitation program.~   "
41441|NCT02514551|"~     The main purpose of this study is to evaluate the efficacy of an alternative dose of~     ramucirumab in combination with paclitaxel in participants with second-line metastatic or~     locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).~   "
41442|NCT02514538|"~     Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as~     bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well~     known, due to the sodium content it has raised a hypothesis that may interfere with the~     control of that risk factor.~      Therefore, the objective of this study is to evaluate the effect on blood pressure of~     effervescent paracetamol compared to non-effervescent, in hypertensive patients.~      This is a multicenter, randomized, controlled, crossover, open, phase IV clinical trial,~     which compares the effect of two different formulations of paracetamol (effervescent or~     non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks~     treatment (coded EUDRACT 2010-023485-53). The washing time between the two periods is~     approximately 1 week (minimum 3 days)~   "
41443|NCT02514525|"~     To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the~     treatment of previously-untreated (treatment naïve) Barrett's Esophagus (BE)~   "
41444|NCT02514512|"~     A research study into a new technology for adjustment of the radiotherapy beam to account~     for movement of lung tumours as the patient breathes during radiotherapy.~   "
41445|NCT02513810|"~     DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is~     required for patients treated with DES for prevention of late or very late stent thrombosis.~     which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that~     consists of a stainless steel stent platform with a textured abluminal surface without use~     of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give~     BioFreedom the advantages of both DES and BMS that may require less duration of DAPT.~     BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety~     and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with~     different duration of DAPT. With proven adequate and safe duration, we will compare between~     one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting~     stents implantation using different properties of BioFreedom and BioMatrix Flex.~   "
41446|NCT02513797|"~     This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the~     safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left~     Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation~     (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or~     longstanding persistent atrial fibrillation.~      This study will be conducted in two stages:~        -  Limited Early Stage (Stage 1): up to 175 subjects at up to 50 sites~        -  Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both~          stages will be included in the primary analysis.~   "
41447|NCT02513784|"~     This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine~     mouthwash can alter the esophageal and gastric cardia microbiome~   "
41450|NCT02513745|"~     Nowadays cataract patient's expectations are closer to those of refractive surgery patients.~     Patients want to be spectacle independent. However, fifteen to twenty percent of cataract~     surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes~     achieving spectacle independence unlikely in this patients unless the astigmatism is treated~     at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal~     incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the~     treatment of choice to correct the astigmatism at time of cataract extraction, a treatment~     plan has to be calculated preoperatively. This planning include: keratometry measurements~     and the use of a calculator to estimate the treatment and orientation of IOL and/or~     placement of the LRIs.~      New technology has been developed and is widely used. Among this technology, we have the~     VERION Image Guided System. This system encompasses a reference unit that takes a picture of~     the eye with the patient in the sitting position creating image of the patient's eye,~     capturing scleral vessels, limbus and iris features. It measures keratometry as well as the~     corneal diameter (limbus) and pupil size. The information captured is transferred~     automatically to its planner where IOL power calculation and astigmatism correction~     calculation are completed. Additionally, intraoperative wavefront aberrometry has been used~     in the last couple of years with increase success.~   "
41451|NCT02513732|"~     The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition~     Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.~   "
41452|NCT02513719|"~     The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real~     world practice in Japanese hospitals.~   "
41453|NCT02513693|"~     Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and~     clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a~     neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between~     optimal surgical conditions (sufficiently deep block) and capability to antagonize the block~     rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep~     neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous~     recovery or reversal of the block with neostigmine, administration of sugammadex at the end~     of the surgery will enable quick and consistent reversal of the block. Project is focused on~     comparison of the parameters of deep and standard neuromuscular blockade - surgical~     conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).~   "
41454|NCT02513680|"~     In today's society, the search for keeping up with the appearance with no visible signs of~     aging has become common. Therefore, many therapies to try to mitigate these senility markers~     are present in specialized clinics. Such therapies seek grounding in the theories of how the~     skin and its appendages respond to the aging process, causing this way, they can be created~     ways to slow or minimize wrinkles and other consequences of this natural biological process.~     However, this process can be accelerated by exposure to ultraviolet light such as to toxic~     substances as well as tobacco, among others. The low-power laser and light emitted diode~     (LED) characterized by being non-ablative light source, which means phototherapy which does~     not cause physical damage to the epidermis, as the case of CO2 laser ablative and other~     methods. This study has the purpose of comparing the effects of combined application of low~     level laser with LED and LED action alone in facial rejuvenation. For this, the analysis of~     these effects will be conducted through digital photography, blinded assessment and customer~     satisfaction questionnaire.~   "
41455|NCT02513667|"~     The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung~     cancer and slow down cancer growth and prevent it from spreading.~   "
41456|NCT02513654|"~     This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting~     bipolar Phase III study for New Drug Application (NDA) filing according to regulatory~     requirement. The primary objective of this study is to evaluate the PK of lamotrigine~     following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This~     study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and~     follow-up Phase (10-17 days after last dosing). After signing the informed consent and~     confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible~     tablet once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then~     will be titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then~     titrated to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of~     the study will be approximately 10 weeks including screening and follow-up phase.~   "
41457|NCT02513641|"~     The purpose of this study is to determine if 2-weeks of nightly exposure (7-12 hours) to~     moderate hypoxia (~2,400 meters or 7,500 feet) improves glucose metabolism in people with~     type 2 diabetes.~   "
41458|NCT02514499|"~     The overall goal of the proposed research is to evaluate the uptake of testing and~     longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2~     negative patients. This model will inform the selection of the outcomes and potential~     mediators and moderators of these outcomes, to inform the debate over utility, risks, and~     benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.~   "
41459|NCT02514486|"~     This study will describe patient-reported symptom burden and concerns, quality of life~     (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial~     treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of~     using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate~     provider satisfaction following delivery of an electronic health record (HER)/EPIC summary~     of these PROs. Secondary aims will estimate differences in referral to available services~     between those providers exposed to the PRO summary and historical controls. BC survivors who~     have completed initial treatment and present within the first year following treatment for~     an end of treatment (EOT)/survivorship focused visit will be the focus of this study.~   "
41460|NCT02514473|"~     To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects~     aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF~     transmembrane conductance regulator (CFTR) mutation~   "
41461|NCT02514460|"~     This is a randomized study comparing stent and plaque excision systems in treatment of lower~     limb (superficial femoral or popliteal artery) ischemia.~   "
41462|NCT02514447|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to topotecan in patients previously treated for~     extensive-stage SCLC.~      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a~     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening~     Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day~     of first dose with study treatment and completes at the Post-Treatment Visit. Approximately,~     100 patients will be enrolled in the study.~   "
41463|NCT02514434|"~     The investigators will investigate the usefulness of ultrasonography versus non-contrast~     magnetic resonance imaging for surveillance of hepatocellular carcinoma through this~     prospective, randomized trial.~   "
41464|NCT02514421|"~     The purpose of this study is to see how well electrochemotherapy works at treating people~     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines~     electroporation and chemotherapy administration. Electroporation uses an electric current to~     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher~     concentration of administered chemotherapy agent. This study will test the safety and look~     at the effect of electrochemotherapy in the treatment of stage III pancreatic~     adenocarcinoma. This study will also help to find the safest and most effective amount of~     electroporation voltage to apply to this type of tumor.~   "
41465|NCT02514408|"~     This pilot clinical trial studies the impact of radical cystectomy (surgery) on the~     expulsion (release) of circulating tumor cells into the blood stream in patients with~     bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of~     tumor cells. Studying the release of tumor cells into the circulation may help doctors~     understand the impact that radical cystectomy has on tumor metastasis and/or tumor~     recurrence.~   "
41466|NCT02514395|"~     Background:~      KOOS is a self -administered instrument which assesses the patient's opinion about the Knee~     associated problems. For now it is available in English & various other languages & is a~     complete instrument in itself.~      In India it has been translated in Hindi so far. However, each province in this country has~     a unique language. Maharashtra is the second largest state in India and Marathi is the~     regional language of the communication. Since KOOS is a self‐report measure, its translation~     in this local language was thought to be necessary. This disease specific measure which is~     originally designed for English speaking region when employed to non-English population~     needed to be translated with unique method to achieve a normative equivalence and linguistic~     validation.~      Methods: After taking permission from KOOS web manager T1, T2, T12, B1 & B2 versions were~     formatted according to the guidelines laid down by AAOS for cross cultural adaptation of~     health status measure. T12 version was sent for the field testing. Total 32 subjects who met~     the eligibility criteria were Included in this study.~      Results:~      Statistical analysis for reliability with test re‐test method suggested Perfect correlation~     (r =1) between day 1 & 2. A range of 0.83‐0.54 co‐relation co‐efficient (r) demonstrated the~     validity of KOOS and its subscales when compared against the 8 different domains of SF‐36.~     All this correlations were statistically highly significant. Sport and recreation subscale~     had many missing responses since many items in this subscale were not appropriate for the~     Maharashtrian cultural set-up. Participants additionally provided the information about~     other functional activities which were difficult to execute due to knee associated pain and~     disability.~      Conclusion: Marathi version of KOOS is proved to be a reliable & valid measure. Future~     scope: this study demonstrate a need to undertake the cross cultural adaptation since a~     constant pattern of impairment revealed in the execution of daily activities such as sitting~     on the floor and attending certain yoga postures etc.~      Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation,~     quality of life.~   "
41467|NCT02514382|"~     This phase Ib trial studies the safety and best dose of wild-type reovirus in combination~     with bortezomib and dexamethasone and to see how well they work in treating patients with~     multiple myeloma that has returned (relapsed) or does not respond to treatment (refractory).~     A virus, called wild-type reovirus, may be able to infect cancer cells and slow the cancer~     growth and kill cancer cells. Bortezomib and dexamethasone may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving wild-type reovirus~     together with bortezomib and dexamethasone may be a better treatment for multiple myeloma.~   "
41468|NCT02514369|"~     Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore~     likely to explain some of the inter-individual variations (efficacy,toxicity,resistance)~     observed during ART. The most common form of human DNA variations consists of a change of a~     base in the nucleotide sequence of an individual at a given position, the single nucleotide~     polymorphism (SNP). Therefore,the purpose of this research will be the identification and~     characterization of the clinical impact of several SNPs in gene coding for transport~     proteins (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be~     involved in the pharmacokinetic pathway of selected ARV drugs for which the therapeutic~     response is difficult to predict. Aside,the influence of these SNPs on the response to~     treatment (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations~     of ARV drugs correlate with therapeutic efficacy but also with the risk of toxicity and of~     virological failure, which is the basis of the therapeutic drug monitoring. However,given~     the intracellular location of HIV, analyzing intracellular drug concentrations is~     fundamental and the investigators will also focus of this new topic.~   "
41469|NCT02514356|"~     The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel~     approaches of using SMS messages (provision of information about electronically measured own~     adherence, as well as in combination with group adherence level) to improve adherence to~     anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in~     Uganda.~   "
41470|NCT02514343|"~     This study evaluates the effect of 10% magnesium sulfate in the rehabilitation of the wrist~     mobility in patients with distal radius fracture treated with percutaneous pinning and~     plaster~   "
41471|NCT02514330|"~     The objective of the present study was to determine the effect of interval session running~     at high intensity with 1% or 10% gradient on the height of the drop jump. The cinematic~     variables concentric phase, eccentric and contact time were compared after the running~     session in both conditions in order to explain possible changes in the jump performance. The~     investigators theorize that the lower eccentric overload in the running to 10% inclination~     promotes higher deleterious effect on power performance of the lower limbs~   "
41472|NCT02514317|"~     The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome~     resistant to medical treatment, clinical course after percutaneous treatment under~     ultrasound guidance. 40 patients will be included in the study. The following parameters~     will be evaluated: patient satisfaction, pain, functional disability, quality of life and~     time to return to work. The medico-economic aspect will be analyzed.~   "
41475|NCT02514278|"~     Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A~     new concept suggests organ preservation as an alternative to rectal excision in good~     responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase~     quality of life. The rational is the fact that 15% of patients have sterilized tumours after~     radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III~     trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm)~     received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized~     between local and rectal excision. The main findings were: the rate of complete pathologic~     response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15%~     ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal~     nodes.~      The objective of the new trial is to increase the proportion of patients treated with organ~     preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox~     has been shown to enhance the response rate. In patients with colorectal metastases,~     response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox~     also increases response and chance of R0 resection rates in initially unresectable~     colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding~     two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the~     investigators expect to increase chance of organ preservation rate, as compared to~     radiochemotherapy alone.~   "
41476|NCT02514265|"~     This study is the second phase of the MAPP Network and is designed to conduct a prospective,~     observational study of men and women with UCPPS, referred to as the Symptom Patterns Study~     (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further~     investigate clinical and biologic factors associated with worsening and/or improvement of~     reported urinary and non-urinary symptoms.~   "
41477|NCT02514252|"~     The goal of this clinical research study is to learn if an investigational dose of fentanyl~     sublingual spray (FSS) can help to control pain in patients with advanced cancer when given~     in an outpatient and inpatient setting.~   "
41478|NCT02514239|"~     The primary objective of part A of this open label phase I dose escalation study is to~     determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v.~     infusion in patients with relapsed and/or refractory multiple myeloma.~      The primary objective of this of part B of this open label, phase I, dose escalation study~     is to determine the maximum tolerated dose (MTD) of BI 836909 given as daily subcutaneous~     injection in patients with relapsed and/or refractory multiple myeloma.~      The secondary objectives are for both parts of the study:~        1. Recommended doses for further development in Phase II~        2. To provide preliminary findings on the safety profiles and assess pharmacokinetic~          profile of BI 836909~        3. To assess pharmacodynamic and anti-tumoral activity of BI 836909...~   "
41479|NCT02514226|"~     Background: Association between periodontal disease (PD) and chronic obstructive pulmonary~     disease (COPD) has been widely studied and the aspiration of periodontal pathogens is one of~     the most accepted causal mechanisms for pulmonary exacerbation. Bronchiectasis is clinically~     quite similar with COPD, including chronic administration of antibiotics, increased systemic~     inflammation and relatively similar clinical symptoms, but for the time being; there are no~     studies that have correlated this condition to PD. This study will evaluate if the scaling~     and root planning (SRP) associated with photodynamic therapy improves periodontal clinical~     parameters, halitosis, reduces inflammatory cytokines in serum and gingival crevicular fluid~     of pro inflammatory cytokines and the quantity of microorganisms associated with~     exacerbation of bronchiectasis in subgingival periodontal microenvironment, sputum and nasal~     lavage at baseline and after 3 months of SRP. Methods/Design: Ninety patients with chronic~     periodontal disease and bronchiectasis will be enrolled in the study and they will be~     treated as follow:G1 control (n = 30) - supragingival scaling (SS) and dental hygiene~     orientation (DHO); G2 experimental (n = 30) - SRP + DHO; G3- experimental (n = 30) - SRP +~     PDT + DHO. It will be analyzed the inflammatory cytokines (interleucin = IL) IL-1, IL-6 and~     IL-8, tumor necrosis factor alpha (TNF-α) and C-reactive protein (CRP) by ELISA using~     commercial kits in serum and gingival crevicular fluid. The quantification of bacterial~     groups commonly associated with exacerbation of bronchiectasis (phyla Proteobacteria and~     Firmicutes) and periodontal diseases (A. actinomycetemcomitans, P. gingivalis, T. forsythia~     e T. denticola), will be evaluated in periodontal pockets, nasal lavage and sputum by~     quantitative PCR at baseline and 3 months after the SRP. G1 patients will receive SRP after~     completion of the research (3 months). Discussion: The results of this protocol will~     determine the efficacy of periodontal treatment in decreasing the total amount~     microorganisms in periodontal pocket, sputum and nasal lavage, the most probable niches of~     bronchiectasis exacerbation, and reducing systemic and local inflammation and halitosis~     after 3 months. It is expected an higher improvement in all parameters measured over 3~     months for G3~   "
41480|NCT02514213|"~     This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150~     alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by~     electroporation (EP) in men with biochemically relapsed prostate cancer.~   "
41481|NCT02514200|"~     The purpose of this study is to determine whether individualized, topography-based corneal~     crosslinking for keratoconus can improve the optical outcomes of the treatment.~   "
41482|NCT02514187|"~     The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a~     cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the~     parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear~     medicine departments across the country. 99Mo is produced by a number of ageing nuclear~     reactors across the world and severe shortages of the isotope have occurred in the past few~     years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a~     regional basis. Since the manufacturing process is different, the safety and efficacy of~     cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its~     routine clinical use.~   "
41483|NCT02514174|"~     Continuos treatment until progression or occurence of intolerable Adverse Event (AE) or end~     of trial. The end of trial is one year after the last patient has entered the study.~   "
41484|NCT02514161|"~     The aim of this study is to assess if an intervention of manual therapy and motor control~     exercises combined with an inspiratory muscle training program is more effective than an~     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in~     moderate smokers. In addition, the study pretends to evaluate the changes caused by the~     intervention regarding possible postural changes and thoracic diameter.~   "
41485|NCT02514148|"~     The purpose of this study is to know wich combination of treatments are the most effective~     in patients with chronic migraine. The study design is a simple blind randomized controlled~     trial (outcomes assessor). The study population: Men and women aged from 18 to 70 years old~     with chronic migraine for at least 12 weeks. Interventions: A combination of techniques~     during 6 weeks (6 sessions; 1 per week)~   "
41486|NCT02514135|"~     The aim of the proposed study is to determine the incidence and prevalence of~     intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive~     care admissions using broad inclusion criteria.~   "
41488|NCT02514109|"~     The diagnosis of sensory neuronopathy is difficult to establish because the only certainty~     criterion is based on the detection of specific lesions in the posterior spinal ganglion~     which is usually not possible. There is to date no clinical and electrophysiological~     criteria or validated biomarker for the diagnosis of this type of neuropathy. In a~     retrospective study, we analyzed the files of patients with peripheral sensory neuronopathy~     certain and established clinical and electrophysiological diagnostic criteria for sensitive~     neuronopathy. We therefore wish now validate these criteria and investigate possible~     associated antibodies on a prospective cohort of patients.~   "
41489|NCT02514083|"~     Background:~        -  Chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) are tumors~          of abnormal B cells that often affect elderly patients. Studies have identified~          critical factors required for the growth of CLL cells. First, CLL cells survive because~          they receive signals through the B-cell receptor. Second, CLL cells benefit from~          interactions with other cells, especially T cells.~        -  Survival signals through the B-cell receptor can be reduced with ibrutinib, which is a~          pill taken daily by mouth. Ibrutinib has been approved by the U.S. Food and Drug~          Administration to treat CLL patients.~        -  T cells that interact with CLL cells can be removed by fludarabine, which is a drug~          given by vein and has been widely used to treat CLL. By adding a short course of~          fludarabine, we hope to complement the action of ibrutinib and restore a healthier~          immune system.~      Objectives:~      - To determine if ibrutinib and a short course of fludarabine can be used safely and~     effectively to treat CLL or SLL.~      Eligibility:~        -  Diagnosed with CLL or SLL requiring treatment~        -  No prior treatment for CLL or SLL~        -  Age greater than or equal to 18 years~        -  Not pregnant or breast-feeding women~        -  Adequate kidney and liver function~      Study Design:~        -  This is a phase II study of 32 patients.~        -  Participants will be screened with blood tests and physical exam for eligibility.~        -  Eligible participants will be treated with ibrutinib and a short course of fludarabine;~             -  Treatment is given in cycles. Each cycle is defined as 28 days. Treatment~               continues as long as it is effective and safe for participants.~             -  Ibrutinib is taken by mouth starting on the first day of cycle 1. Ibrutinib is~               continued daily.~             -  Fludarabine is given through vein on the first five days of cycle 3 and 4 only.~               Each infusion takes approximately 30 minutes.~             -  Participants will also take drugs that prevent infections and other complications.~        -  Participants under treatment will have clinic visits with tests including:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  CT and PET scans: They will lie in a machine that uses a computer to take serial~               images of the body.~             -  For the PET scan, a radioactive sugar is injected into a vein for clear~               visualization of the body.~             -  EKG: To assess heart rhythm.~             -  Bone marrow and lymph node biopsies~        -  Participants should avoid grapefruit, Seville oranges, and grapefruit juice during the~          study. They also should avoid any live vaccines.~   "
41490|NCT02514070|"~     Background:~      - Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are~     substances found in foods such as cold-water fish and shellfish that are essential for good~     health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA)~     and docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular~     health.~      Objective:~      - To understand the effects of EPA and DHA on metabolism.~      Eligibility:~      - Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the~     blood) levels of 100 mg/dL or higher~      Design:~        -  The study will last 20 to 24 weeks.~        -  Participants will have 4 visits to the NIH Clinical Center. These will include:~        -  Medical history~        -  Physical Fasting blood and urine tests~        -  CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.~        -  Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3~          times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks~          (a wash-out period). They will then take the capsules again for 6 or 7 weeks.~        -  Participants will keep a food journal.~   "
41491|NCT02514057|"~     Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well~     established and validated questionnaires that do not fully fit the requirements of an~     investigator concerned about gastrointestinal side effects in a patient without primary~     gastrointestinal disease.~   "
41492|NCT02514044|"~     The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine~     (Dexedrine) and transcranial direct current stimulation with melodic intonation therapy for~     treatment of aphasia after stroke. The target population is patients with chronic speech~     deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed~     project will help in the design of future larger studies.The safety phase will use~     cross-over, placebo controlled and single-blinded design. 10 participants with post stroke~     chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of~     combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups,~     randomized, sham and placebo controlled, and double-blinded design in which 48 participants~     with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1)~     dextroamphetamine therapy with active stimulation, 2) placebo medication with active~     stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication~     with sham stimulation for the same duration.~   "
41493|NCT02514031|"~     This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in~     subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has~     not been treated with gemcitabine.~   "
41494|NCT02514018|"~     The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when~     used as a vaccine vector in conjunction with HIV to generate durable immunity systemically~     and at the mucosa. This study aims to characterize mucosal immunity before and after~     vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to~     immune activation state, mucosal homing properties and VZV-specific effector immune~     responses in healthy women at low risk for HIV acquisition.~   "
41495|NCT02514005|"~     It is a randomized clinical trial comparing two treatments in patients affected by the~     patellofemoral syndrome (PFS). Our aim was to investigate the effectiveness of inclusion of~     trigger point dry needling into the management of idividuals with patellofemoral pain~     syndrome.~   "
41496|NCT02513992|"~     Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an~     established technique to localize the ictal onset zone during presurgical evaluation of~     refractory focal epilepsy. When seizures last less than 10 seconds, localizing information~     is often not obtained. Since it takes around 30 seconds before the tracer reaches the brain~     after intravenous injection, ictal hyperperfusion most likely has already switched to~     postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta~     proximal to the cerebral arteries, which will allow a true ictal injection in patients with~     seizures of short duration.~   "
41531|NCT02513355|"~     Research purpose:~      Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination~     chemotherapy regimens including cisplatin two medicine first-line treatment of advanced~     non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.~   "
41616|NCT02512250|"~     The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of~     factor concentrates in patients with hemophilia and other severe bleeding disorders in~     Switzerland.~   "
41497|NCT02513979|"~     An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in~     neuropathic pain with promising results. A considerable number of patients undergoing~     surgery under general anesthesia are hypertensive and receive drugs to control high blood~     pressure, including angiotensin II receptor antagonists. These drugs may attenuate the acute~     and/or chronic postoperative pain or decrease the analgesic requirements after surgery. The~     aim of the present study is to assess the early postoperative pain and analgesic~     requirements in patients treated with antagonists of the angiotensin II receptors for at~     least three months before surgery compared to normotensive patients.~   "
41498|NCT02513966|"~     There is a decrease in the amount of blood components used during cardiac surgery in the~     last four years. As the hemovigilance team of the investigators' Hospital the investigators~     want to find out the causes and effects of this decrease.~   "
41499|NCT02513953|"~     Objective:To present an extremely rare site of occurrence of endometriotic cyst in the~     layers of Broad Ligament.~      Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in~     lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were~     performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary~     and uterus was identified and excised by Four Port laparoscopic interventional surgery.~   "
41500|NCT02513940|"~     Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with~     corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the~     US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in~     women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for~     drug-induced TdP in men, possibly due to declining serum testosterone concentrations.~     Available evidence shows an inverse relationship between QTc intervals and serum~     testosterone concentrations. In addition, experimental data, including those from the~     investigators' laboratory, suggest that both exogenous testosterone or progesterone~     administration may be protective against prolongation of ventricular repolarization and TdP.~     Specific Aim: Establish the influence of transdermal testosterone administration and oral~     progesterone administration as preventive methods by which to diminish the degree of~     drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis:~     Transdermal testosterone administration and oral progesterone administration both~     effectively attenuate drug-induced QT interval response in older men. To test this~     hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a~     3-way crossover study to men 65 years of age or older. QTc interval response to low-dose~     ibutilide will be assessed. The primary endpoints will be individually-corrected QT interval~     (QTcI) response to ibutilide, in the presence and absence of testosterone, and in the~     presence or absence of progesterone: 1) Effect on pre-ibutilide QTcI, 2) Effect on maximum~     post-ibutilide QTcI, 3) Effect on % change in post-ibutilide QTcI, and 2) Area under the~     QTcI interval-time curves.~   "
41501|NCT02513927|"~     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor~     for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in~     hypertensive patients was based on the average blood pressure (BP) measured in the clinic.~     Accumulated data has shown that target-organ damage is related not only to 24-h mean~     intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension.~     Growing evidence demonstrated that BPV has considerable prognostic value for all-cause~     mortality and cardiovascular outcomes, independent of average BP.~      At present, the normal range of BPV is not very clear. There are many studies about the~     effects of different kinds of drugs on blood pressure, but the clinical researches about the~     impacts of antihypertensive drugs on BPV are limited, and the conclusion is still~     controversial.~   "
41502|NCT02513914|"~     Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is~     characterized by elevated intracranial pressure, headache, and if severe, vision loss. IIH~     is difficult to treat. Medical management may not adequately resolve the symptoms, and~     surgical management (primarily through cerebrospinal fluid [CSF] shunting) has a high~     failure rate. Recently, a relationship between IIH and stenosis of the dural venous sinuses~     (the veins that drain blood from the brain) has been reported. In patients with IIH in whom~     there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus~     may improve patients' objective symptoms (such as visual loss and papilledema) and~     subjective symptoms (such as headache). This study will determine whether dural venous sinus~     stenting is as effective as CSF shunting (considered the standard surgical treatment) in~     treating IIH patients who have moderate vision loss and stenosis of the dural venous~     sinuses.~   "
41503|NCT02513901|"~     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)~     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected~     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.~     HIV persistence is thought to stem primarily from the presence of integrated copies of the~     proviral genome within long-lived cells. Because active viral gene expression causes cell~     death due to viral cytopathic effects and the immune response, long-lived cells likely~     harbor transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular~     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)~     these latently infected cells. This will make the HIV infected cells visible to the immune~     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate~     (Kill) the infected cells. The purpose of this study is to evaluate the safety and~     efficacy of multi-dose Chidamide in combination with antiretroviral therapy in HIV-infected~     adults with suppressed viral load.~   "
41514|NCT02513576|"~     Sternal instability caused by mediastinitis is one of the most feared complications for~     cardiac surgery team for generating large commitments and functional damages to patients.~     Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces~     forces that result in a corset-like action and anterior thoracic cage muscles too may~     assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might~     contribute to the recovery of functional aspects. The aim was to evaluate whether~     contraction and strengthening the abdominal muscles could improve lung function and~     respiratory muscle strength in patients with sternal instability.~   "
41515|NCT02513563|"~     The purpose of this study is to find out what effects (good and bad) AZD1775 used in~     combination with carboplatin and paclitaxel will have on participants and their cancer.~   "
41504|NCT02513888|"~     PREVENT-WIN study has three components.~      The work plan will have the following S&T components. Component 1: Cross-sectional Study~      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened~     randomly for the vitamin D deficiency and its determinants including duration of sun~     exposure.~      Component 2: Prospective Study~      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women~     with vitamin D deficiency. The women will be recruited from cross-sectional study, out~     patient department and health camps and they will be followed up for 2 years. The women will~     be randomized into two groups; lifestyle modification counseling along with intervention~     with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed~     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of~     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will~     be compared.~      Component 3: Information Education and Communication (IEC) Activities:~      There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas.~     IEC material will be developed and IEC activities through various modes like lectures,~     workshops, group discussions, leaflets/booklets distribution and audio video media shows~     (Hindi and English) will be used for educating health professionals, Medical and paramedical~     workers and various village level health functionaries like, Multi purpose workers,~     anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of~     Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told~     about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun~     exposure and adverse health effects of vitamin D deficiency.~   "
41505|NCT02513875|"~     The work plan will have the following S&T components. Component 1: Cross-sectional Study~      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened~     randomly for the vitamin D deficiency and its determinants including duration of sun~     exposure.~      Component 2: Prospective Study~      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women~     with vitamin D deficiency. The women will be recruited from cross-sectional study, out~     patient department and health camps and they will be followed up for 2 years. The women will~     be randomized into two groups; lifestyle modification counseling along with intervention~     with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed~     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of~     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will~     be compared.~   "
41506|NCT02513862|"~     The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is~     effective in reducing allogeneic blood transfusions during aortic surgery using deep~     hypothermic circulatory arrest.~   "
41507|NCT02513849|"~     Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive~     5 years once diagnosed. It is more common in men than women, and men appear to have a worse~     prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which~     exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well~     described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors~     are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer~     however, is less well defined. Work conducted by the investigators, as well as another~     research group in Australia showed that antioestrogens including tamoxifen, reduce~     oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the~     effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators~     propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who~     aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for~     4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a~     flexible camera that is passed into the mouth through the gullet into the stomach). The~     biopsy will be compared with the biopsy taken at the time of diagnosis to determine if~     tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does~     slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer~     taking tamoxifen for a longer time period to determine if there is any clinical benefit.~   "
41508|NCT02513836|"~     In this vital study, the investigators will develop an innovative Opioid Safety (Op-Safe)~     Program for use in pain clinics. The Op-Safe Program consists of two key components:~     Educating patients with an informative brochure and video developed by the Institute for~     Safe Medication Practices (ISMP) Canada, and a screening algorithm to identify unrecognized~     sleep apnea in patients taking opioids for chronic non-cancer pain.~   "
41509|NCT02513823|"~     This pilot study will examine the effectiveness of vitamin D supplementation on reducing~     blood pressure and improving endothelial function. Premenopausal African American women will~     be recruited. Potential subjects will have systolic and diastolic blood pressure measured~     following the American Heart Association Blood Pressure Guidelines. Any individual with an~     average blood pressure > 140/90 mmHg will be referred to their personal physician for follow~     up. Participants with blood pressure readings <140/90 mmHg will be consented and then~     instructed to record food intake for three days to estimate usual dietary intake at baseline~     and at the 10th week timepoint. At the baseline clinic visit a 10 week supply of vitamin D3~     supplements (2,000 IU/day; Nature Made ®) will be given to participants and log sheets~     provided to record supplement intake. For the baseline and the 10 week visits, participants~     will fast overnight and refrain from consuming any caffeinated products, vitamins, or~     medications that may affect vascular tone, and will refrain from smoking. Three successive~     systolic and diastolic blood pressure measurements and the average of the last two~     measurements will be calculated. Anthropometric and body fat distribution assessments will~     be performed. Height and weight will be measured. Percent body fat will be determined by~     bioelectric impedance (Tanita BF-350) by C Moore. Body mass index (BMI) will be calculated~     as weight in kilograms (kg) divided by height squared (m2). Pulse amplitude tonometry (PAT)~     will be measured with the EndoPAT 2000 (Itamar Medical Ltd) which records digital pulse wave~     amplitude (PWA) using fingertip plethysmography. A reactive hyperemia index (RHI) measures~     nitric-oxide dependent changes in vascular tone. Endothelial dysfunction is classified as a~     RHI < 1.67 with average normal endothelial RHI values ranging between 1.7 and 2.0. Blood~     will be drawn for measurement of serum 25(OH)D concentrations by chemiluminescence~     immunoassay( Abbott Architect). Vitamin D deficiency will be defined as serum 25(OH)D levels~     less than 20 ng/mL (50 nmol/L) and vitamin D insufficiency as 21 to 29 ng/mL (50 to 80~     nmol/L). Descriptive statistics, including means and standard deviations for continuous~     variables and frequencies and percentages for categorical variables, will be calculated for~     study variables. To answer the primary research questions, within subjects repeated measures~     analysis of variance (ANOVA) tests will be conducted to test if any differences in blood~     pressure, serum 25(OH)D concentrations, and RHI are statistically different after 10 weeks~     of supplementation with 2,000 IU/d of vitamin D. Furthermore, exploratory multivariate~     linear regression models will be constructed to determine relationships between vitamin D~     status and vascular function parameters (blood pressure, RHI) before and after adjustment~     for age and BMI.~   "
41510|NCT02513628|"~     Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day~     after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath~     diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works~     showed that ONSD measurement could be used to predict outcome in post-CA patients.~      The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement~     to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in~     post-cardiac arrest patients treated with therapeutic hypothermia (TH).~   "
41511|NCT02513615|"~     Peritoneal dialysis (PD) is a type of kidney replacement therapy for patients with chronic~     kidney disease where the peritoneal membrane is used to filter the blood. Exposure to PD~     fluid results in scarring of the peritoneal membrane and increased blood vessel growth. This~     condition can progress even when peritoneal dialysis is stopped. Therefore, the~     investigators hypothesize glucose in the dialysis fluid may result in DNA modifications~     called epigenetic changes. These changes modify how genes are expressed and how cells~     function. The investigators want to study these epigenetic changes and the effect on~     peritoneal membrane scarring, blood vessel growth and peritoneal membrane function.~   "
41512|NCT02513602|"~     The evaluation of the bone, using several techniques and on several aspects will be the~     purpose to study the possible impact of the kidney transplant (and, extensively, the~     pre-transplant dialysis, the organ replacement and the immunosuppressive therapy) could have~     on the bone metabolism and on the density of the bone where the implants are placed. The~     assessment on the bone density only in a retrospectively selected population that underwent~     the same surgical procedure will help the comparison of the data to get a satisfactory~     conclusion. The evaluation of other clinical and instrumental parameters in the test group~     makes the kidney-transplant patients bone quality clear, and will consequently demonstrate~     if implants are a feasible therapy for these patients.~   "
41513|NCT02513589|"~     Evaluating an innovative molecular imaging technique to visualize inflammation of the~     atherosclerotic plaque in patients with a recent ischemic stroke (<15 days) with carotid~     stenosis> 50%, by performing a Positron emission tomography-computed tomography (PET-CT)~     with PBR06 18F, a tracer for Translocator protein (TPSO).~   "
41516|NCT02513550|"~     The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in~     participants with plaque psoriasis.~   "
41517|NCT02513537|"~     The ESA is currently preparing a guideline on the management of postoperative delirium~     (POD), which attempts to reduce the impact of postoperative delirium and provide~     recommendations for prevention, diagnostics and treatment of delirium outside the intensive~     care unit. The guidelines are going to be published during 2015.~      While the guideline provides recommendations for daily practice, assessment of current~     practice and knowledge is of utmost importance, because the implementation and the~     measurement of a change in clinical practice will be dependent on these measurements.~      This Survey has been approved by the Scientific and Research Committees of the European~     Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the~     institutional ethical committee of Charité - Universitätsmedizin Berlin.~   "
41518|NCT02513524|"~     High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke,~     kidney failure and death. This risk is much higher in those with 'resistant' hypertension,~     in whom the blood pressure remains high despite more than 3 blood pressure medicines.~     Current estimates of the proportion of individuals with resistant hypertension may be an~     overestimate, since some of them are not actually adherent (i.e. not taking the medicines~     they are prescribed). Methods to detect non-adherence, such as asking the patient, counting~     pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where~     patients are administered medicines under observation by a health care personnel) is quite~     useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic,~     before more tests and interventions (such as CT scans, renal angiogram) are performed.~      In this study, the investigators will measure the proportion of patients with resistant~     hypertension who are non-adherent based on direct observed therapy, and follow them up to~     examine the impact of this diagnosis.~   "
41519|NCT02513511|"~     Awake intubation is a recommended safety procedure in specific cases where the intubation or~     ventilation before general anesthesia is at risk.~      Numerous techniques to allow awake intubation have been described, such as pure awake~     technique, local anesthetics or intravenous sedation for example.~      Hypnosis is used for various operating room techniques and surgeries. The investigators aim~     to analyze the feasibility of awake laryngoscopy and intubations on patients placed under~     hypnosis alone.~   "
41520|NCT02513498|"~     This phase II trial studies how well ixazomib citrate works in treating patients with~     chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a~     donor bone marrow or blood cell transplant, usually occurring more than three months after~     transplant, in which donor cells damage the host tissue. Ixazomib citrate may be an~     effective treatment for chronic graft-versus-host disease.~   "
41521|NCT02513485|"~     The purpose of this study is to learn more about the changes that happen in the brain and~     the body when a person is depressed. This study will determine if the level of inflammation~     in the body is related to symptoms of depression, how well the person thinks, and how~     certain brain regions communicate.~   "
41522|NCT02513472|"~     This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in~     combination with pembrolizumab in participants with metastatic triple-negative breast cancer~     (mTNBC) previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or~     targeted anticancer agents) in the metastatic setting.~   "
41523|NCT02513459|"~     This is an open label, single group, long term safety extension trial to provide a long-term~     treatment option for subjects who responded to treatment with BI 655066/ABBV-066~     (risankizumab) in a preceding trial.~   "
41524|NCT02513446|"~     The primary objective of this trial is to investigate the effect of multiple doses of~     itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of~     safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore,~     the pharmacokinetics of the metabolite BI 1072668 will be explored.~   "
41525|NCT02513433|"~     This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine~     and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.~   "
41526|NCT02513420|"~     Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These~     damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM~     results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and~     promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the~     perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks~     before delivery, to withstand stretching which will be submitted during childbirth. No~     studies in the world that have explored the effect of the perineal muscle training on the~     avulsion of MEA.~      Objective: To quantify the proportion of primiparous that result with avulsion of LAM after~     their first birth among those performing perineal muscle training from week 33 of gestation~     and those with usual prenatal care.~   "
41527|NCT02513407|"~     This randomized pilot research trial studies how well Eat, Move, Live (EML) works in~     reducing chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet,~     and physical inactivity are linked to increased cancer risk, especially hormone-related~     cancer (example, breast cancer). Improving healthy lifestyle practices, namely increasing~     physical activity and encouraging healthy eating behaviors may reduce the risk of getting~     cancer and chronic disease.~   "
41528|NCT02513394|"~     This is a prospective, two arm, international, multicenter, randomized, open-label Phase III~     study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine~     therapy for patients with HR+ / HER2- early breast cancer (EBC).~      The purpose of the PALLAS study is to determine whether the addition of palbociclib to~     adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-~     early breast cancer. Assessment of a variety of correlative analysis, including evaluation~     of the effect of palbociclib in genomically defined tumor subgroups, is planned.~   "
41529|NCT02513381|"~     This is a double blind randomised placebo-controlled study involving women with polycystic~     ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or~     placebo for three months. The main hypothesis of this study is Vitamin D improves hormonal,~     metabolic and cardiovascular risk markers in women with PCOS.~   "
41530|NCT02513368|"~     The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at~     implant site in order to evaluate if the increased bucco-lingual bone thickness could~     enhance the stability of peri implant soft tissue, when compared to the grafting technique (~     bilaminar technique), performed in association with implant placement .~   "
41533|NCT02513329|"~     Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact~     their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic~     women with breast cancer who are on anti-estrogens and are seeking relief from moderate to~     very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer~     on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS)~     with moderate to very severe VMS will be enrolled as participants in this study.~   "
41534|NCT02513316|"~     Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after~     cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout~     the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant~     (without prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with~     follow up for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an~     average of two years. The main baseline exposures (risk factors of interest) are the~     presence of cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic~     polymorphisms in candidate genes with potential functional relevance to ICH risk.~      Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The~     investigators will also recruit 600 patients admitted to participating centres with ICH~     (with a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase~     the power of the genetic studies. The investigators will collect clinical and imaging data~     from these ICH cases to investigate risk factors associated with anticoagulant-related ICH~     compared to non anticoagulant-related ICH.~   "
41535|NCT02513303|"~     The purpose of this study is to determine whether the use of the Sirolimus-eluting Collagen~     Implant will improve AV Fistula outcomes, including time to first dialysis and suitability~     for dialysis at 6 months, in subjects undergoing surgical creation of an AV fistula for~     providing vascular access for hemodialysis.~   "
41536|NCT02513290|"~     The purpose of this study was to verify whether there were differences in health-related~     quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to~     those treated with loratadine 10 mg.~   "
41537|NCT02513277|"~     People with learning (intellectual) disabilities have more health problems than the rest of~     the population; they are less likely to access help and have lifestyles that may increase~     their risk of getting diabetes (for example, poor diet and lack of physical activity).~     People with learning disabilities may also be prescribed drugs or have certain medical~     conditions (such as Down's syndrome) which can make their chances of getting diabetes~     greater.~      Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys,~     nerves and feet. Impaired glucose regulation happens when sugar levels in the blood are~     higher than normal but are not high enough to be diagnosed with diabetes. People with~     impaired glucose regulation are more likely to develop diabetes, heart disease and stroke in~     the future. If people with impaired glucose regulation make changes to their lifestyle (diet~     and exercise) they can prevent or delay getting diabetes.~      The aim of this study is to screen people with learning disabilities for diabetes and~     impaired glucose regulation. The investigators also want to find out the best way to give~     people with learning disabilities some education around healthy lifestyles (for example,~     eating and exercise) to help with prevention of diabetes and cardiovascular disease.~     Therefore, the investigators also aim to develop a lifestyle education programme that is~     suitable for use in this population and test whether it is feasible and acceptable.~   "
41538|NCT02513264|"~     There is a need for people to take part in research studies to learn more about diseases and~     how to treat them. The Registry for Asthma Characterization and Recruitment 2 (RACR2) will~     create a database of participants with asthma and nasal allergies, or risk factors for these~     conditions, who are potentially eligible for future Inner City Asthma Consortium (ICAC)~     trials. The registry database will include assessments of various asthma and allergy~     characteristics to achieve a more efficient, selective recruitment of these participants for~     other protocols.~   "
41539|NCT02513251|"~     Pain is defined as An unpleasant sensory and emotional experience associated with actual or~     potential tissue damage, or described in terms of such damage. In particular, chronic pain~     has significant impact on health care cost and socio-economic aspects of the society. It is~     clear that the development of effective chronic pain management is paramount in reducing the~     significant socio-economic burden of this common healthcare problem.~      One of the difficulties in measuring outcomes in chronic pain patients is the subjective~     nature of pain. The McGill Pain Questionnaire (MPQ) was developed in 1975 with the aim of~     quantifying the subjective pain experiences of patients. Since then it has become one of the~     major assessment tools in evaluation of chronic pain patients during the course of~     treatments. The Short Form McGill Pain Questionnaire (SF-MPQ) developed in 1987 has further~     refined pain descriptors into sensory and affective domains, and incorporating the~     Visual Analog Scale (VAS) for easier administration in hospitals and clinics. The validity~     and reliability of both the original English and translated versions of MPQ and SF-MPQ have~     been well demonstrated. The latest version of Short Form McGill Pain Questionnaire~     (SF-MPQ-2) included descriptive terms for neuropathic pain which expanded the scope of~     coverage on chronic neuropathic pain patients. It has also been evaluated in cancer pain~     patients. Translated versions of SF-MPQ-2 showed good reliability and validity. Therefore~     the investigators devised this study to (1) translate SF-MPQ-2 into Traditional~     Chinese-Cantonese (C-SF-MPQ-2) suitable for use in Hong Kong patients, (2) examine the~     validity, reliability and psychometric properties of this translated version in Hong Kong~     patients.~   "
41540|NCT02513238|"~     The current study aims to assess the safety and feasibility of the injection of autologous~     adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia~     in head and neck cancer participants. The project can potentially help to develop a~     clinically relevant treatment option for the growing number of patients suffering from~     xerostomia after radiotherapy. The development of new therapies is especially important,~     since only sub-optimal symptomatic treatments are currently available and the symptom of~     xerostomia greatly reduces the quality of life.~   "
41551|NCT02513095|"~     Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel~     study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered~     intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is~     defined as effective body cooling, which should be implemented as quickly as available after~     diagnosis of exertional heat stroke.~   "
41541|NCT02513225|"~     The goal of this research study is to evaluate the impact of a paraprofessional-delivered,~     culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD),~     substance use and poor mental/emotional health among American Indians (AI) through a~     Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities~     and have unique cultural and social determinants in Native communities. If aims are~     achieved, scientific knowledge and community-based practice will be advanced in areas vital~     to AI communities, and to STD and drug prevention science.~      Prior to this study, the investigators applied findings from research protocol~     (IRB#00005929) and adapted a brief intervention to reduce risk and increase protective~     behaviors for STDs, HIV/AIDS, substance use and poor mental/emotional health, and to promote~     STD screening. The specific aim of the current study is to compare the efficacy of the~     adapted brief intervention vs. a comparison condition on participants' condom use, STD~     screening and treatment-seeking behaviors, substance use and emotional/mental health~     outcomes at 3 and 6 months post-intervention.~   "
41542|NCT02513212|"~     This study will determine the effects toothbrush type (power or manual) has on the safety~     and effectiveness of professional dentinal hypersensitivity treatment with a marketed~     oxalate-containing solution.~   "
41543|NCT02513199|"~     The purpose of this study is to develop better ways to treat liver cancer, known as~     hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to~     treat tumors in the liver when they are small but after they grow past a certain size, local~     therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency~     Ablation (RFA) are not effective. The purpose of this study to test the combination of two~     known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together~     to treat larger or difficult to access liver tumors. Each treatment has been shown to work~     well but has limitations. The study will combine the treatments in an organized sequence and~     monitor closely how effective this combination controls tumors.~   "
41544|NCT02513186|"~     Primary Objective:~      To determine the maximum tolerated dose (MTD) and recommended dose (RD) of isatuximab when~     administered in combination with bortezomib, cyclophosphamide, and dexamethasone based on~     the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed MM~     non-eligible for transplantation.~      Secondary Objectives:~        -  To characterize the overall safety profile of isatuximab in combination with~          bortezomib, cyclophosphamide, and dexamethasone, including cumulative toxicities.~        -  To characterize the pharmacokinetic (PK) profile of isatuximab and combination~          components.~        -  To evaluate the immunogenicity of isatuximab in combination treatment.~        -  To evaluate the preliminary antitumoral activity of the combination.~   "
41545|NCT02513173|"~     Segmental stabilization exercise has been shown to be effective in the rehabilitation of low~     back pain (LBP). Due to the isometric nature of segmental stabilization exercise, manual~     therapists use various verbal instructions to elicit lumbar multifidus muscle contraction.~     The purpose of this study was to assess whether or not three verbal instructions would alter~     muscle thickness of the lumbar multifidus differently in asymptomatic individuals and~     patients with LBP.~      Three verbal instructions were selected for this study: (1) swell the muscle underneath the~     transducer, (2) draw your belly button in towards your spinal column, and (3) think about~     tilting your pelvis but without really doing it. Lumbar multifidus muscle thickness was~     determined using parasagittal ultrasound imaging. Measurements of muscle thickness were~     collected at rest and during verbal instructions from 21 asymptomatic adults and 21 patients~     with LBP. Percent changes of muscle thickness during contraction and at rest were compared~     between groups and across verbal instructions.~   "
41546|NCT02513160|"~     The primary objective of this study is to evaluate the efficacy of beclomethasone~     dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation~     (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with~     persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose~     and pre-rescue bronchodilator) Forced expiratory volume in 1 second (FEV1) area under the~     effect curve from time 0 to 6 weeks (AUEC[0-6wk]).~   "
41547|NCT02513147|"~     The purpose of this study is to assess changes in viral reservoir after changing IP/r to~     dolutegravir in HIV-1 infected patients maintaining undetectable viral load on~     Antiretroviral Therapy (ART).~   "
41548|NCT02513134|"~     Recently a prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss~     Meditec AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced~     that allows measurements of the crystalline lens as well as the lens capsule itself after~     removing the crystalline lens of cataract patients intra-operatively. This device uses OCT~     technology to create high resolution B-scans (=images) of the anterior segment of the eye.~     The OCT was shown to be highly reproducible for ACD measurements pre-operatively 12 and~     small changes of the IOL/crystalline lens can be detected 13.~      In a previous study (EK-10-125-0710) that was recently published in the journal~     Investigative Ophthalmology & Visual Science it was shown that intra-operative~     measurements of the anterior lens capsule improve the refractive outcome theoretically.14~     However, in this previous study conventional eye models were used for IOL power calculation~     and only the intra-operative measurement replaced pre-operative ACD measurements.~      Aim of this study is to observe, whether the postoperative refractive outcome could be~     improved theoretically by using both pre- and intra-operative measurements for retrospective~     IOL power calculation with new eye models.~   "
41549|NCT02513121|"~     This is an investigator initiated study being conducted in equal numbers at two sites, UC~     San Diego and Emory University. The purpose of this study is to understand the potential of~     a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children.~     Forty boys with NAFLD will be randomly assigned to either an intervention group or a~     habitual diet control group. The intervention will be a low sugar diet for a period of 8~     weeks. The effect of this dietary change will be assessed using advanced MRI testing to~     measure liver fat.~   "
41550|NCT02513108|"~     The purpose of this study is to provide information on safety of same day discharge after~     uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian~     clinical practice. The investigators also think that is in patients interest to stay as~     short time as possible in hospital and this will be measured using standardised quality of~     life questionnaires.~   "
41566|NCT02512900|"~     To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of~     MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.~   "
41552|NCT02513082|"~     This study aims to compare the effectiveness of adductor canal block and femoral nerve block~     in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and~     effective in pain control after total knee arthroplasty. But some authors insist that~     quadriceps muscle power was decreased by femoral nerve block. The study design is a~     double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously~     bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve~     block on one leg and adductor canal block on the other, in addition to combined general~     anaesthesia. The primary outcome was comparative postoperative pain in either extremity at~     four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes~     included motor strength by cybex test.~   "
41553|NCT02513069|"~     The primary goal of the study is to evaluate the effectiveness of a combined tele-health and~     contingency management (CM) intervention that the investigators call mobile CM, or mCM, in~     promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile~     system to reward non-smoking, smoking cessation counseling, and smoking cessation~     medications. The primary aim is to evaluate how effective this intervention is in promoting~     smoking abstinence compared to telehealth interventions for smoking cessation.~   "
41554|NCT02513056|"~     The overall objective of this protocol is to evaluate the safety and utility of diagnostic~     MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and~     Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.~   "
41555|NCT02513043|"~     This pilot study is designed to obtain preliminary data on the safety, acceptability, and~     feasibility of direct-to-consumer telemedicine abortion.~   "
41556|NCT02513030|"~     The SIMPLE study was a large one, and lasted quite a few years due to its design as a~     randomized controlled trial and the follow up needed to reach an endpoint. The investigators~     aim to conduct an observational pilot study looking at frequency of positive findings during~     VF testing . The comparator will be the rate of findings during testing in the Simple trial.~     If the investigators will find an increased rate of findings (significantly higher than in~     the Simple trial ) it may set the stage for a randomized controlled trial of replacements ,~     along the line of the Simple trial , or to a recommendation to continue VF testing in all~     ICD replacements.~   "
41557|NCT02513017|"~     Research has shown that persons who have trouble sleeping and experience stress are at risk~     of developing heart diseases. Two treatments, called stimulus control instructions and sleep~     efficiency treatment, that do not involve sleeping pills, have been found effective in~     managing trouble sleeping. This study will be undertaken to find out if the two treatments~     are effective in improving sleep, and reducing stress and the risk of heart diseases.~     Persons with trouble sleeping may have a preference for either treatment. It is believed~     that if persons get the treatment they prefer, then they will be satisfied with the~     treatment and comply with it, and experience improvement in their sleep. This study will~     also examine the extent to which giving persons the treatment of their choice, as compared~     to giving persons treatment based on chance, will lead to higher satisfaction and compliance~     with treatment, and improved sleep. About 300 persons who experience trouble sleeping will~     be included in the study. They will be requested to complete a questionnaire and a sleep~     diary before and after they receive treatment, as well as 6 month and one year later.~   "
41558|NCT02513004|"~     This study is designed to test the hypothesis that the onset of the antiplatelet effect~     90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of~     clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour~     in patients undergoing one-stop Hybrid coronary revascularization(HCR).~   "
41559|NCT02512991|"~     This study compares patients bound for Percutaneous Coronary Intervention (PCI) who were~     transported by either ground ambulance or emergency medical helicopter. The investigators~     describe long-term follow-up in relation to mortality and labour affiliation.~   "
41560|NCT02512978|"~     Based on accumulating evidences showing that hypothyroid status is associated with poor~     prognosis among acute myocardial infarction (AMI) patients, the study is designed to~     evaluate whether replacement treatment with levothyroxine could have beneficial effects on~     patients with AMI and hypothyroidism. This is a multicenter prospective~     computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to~     levothyroxine group or standard therapy group.~   "
41561|NCT02512965|"~     The purpose of this study is to find out if SBRT is better than CRT at controlling pain in~     the spine 3 months after receiving treatment.~   "
41562|NCT02512952|"~     Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along~     with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in~     the treatment of intrabony defects (IBDs).~      Materials and methods: Study was conducted on subjects reporting to the Department of~     Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90~     periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone~     (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each~     subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm~     in at least three teeth.~   "
41563|NCT02512939|"~     This study will assess the next generation of blood tests for latent TB infection, which may~     be able to indicate how treatment is working as well as in diagnosis infection.~   "
41564|NCT02512926|"~     This study evaluates the use of carfilzomib in combination with cyclophosphamide and~     etoposide for children with relapsed/refractory solid tumors or leukemia. The medications~     cyclophosphamide and etoposide are standard drugs often used together for the treatment of~     cancer in children with solid tumors or leukemia.~      Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults~     with multiple myeloma (a type of cancer). However, this drug is not approved for the disease~     being treated in this study. Since carfilzomib has not yet been used in this setting to~     treat this condition, the investigators must first find the best dose to give. The~     investigators are looking for the highest dose of carfilzomib that can be given safely.~     Therefore, not all children taking part in this study will receive the same dose of the~     study drug in the first part of the trial.~   "
41565|NCT02512913|"~     The purpose of this research is to adapt and implement a pregnancy and postnatal smoking~     cessation intervention for couple that will begin early in pregnancy and have an additional~     postnatal component.~   "
41567|NCT02512887|"~     Hypospadias is one of the most common congenital malformations of the genitalia in boys, and~     is typically managed by surgical intervention. During pediatric urological surgery, caudal~     anesthesia is one of the most common regional anesthetic techniques used. Also known as~     caudal block, it has been shown to be a safe and effective anesthetic technique in children~     with a low incidence of anesthesia-related complications.While the reported incidence of~     complications directly associated with caudal block is low, there is scarce and inconclusive~     evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a~     result, the objective of this superiority, randomized controlled trial is to assess whether~     the use of caudal anesthesia, when compared to dorsal penile block, is associated with a~     higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.~   "
41568|NCT02512874|"~     Frailty is a state of health with predisposition to adverse events, morbidity and mortality.~     Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting.~     Frailty is associated with increased hospitalizations and death in lung disease. It is~     unknown if pulmonary rehabilitation will improve frailty markers.~   "
41569|NCT02512861|"~     All pediatric patients who undergo cardiac surgery require analgesic medications for~     postoperative pain control and many require sedation to facilitate comfort with cares.~     Parasternal infiltration of local anesthetic for nerve blocks is a simple option to~     postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve~     block administered in pediatric patients undergoing cardiac surgery will reduce the~     requirement of Opioids and other pain medications as well as decrease postoperative pain~     scores. This is a prospective, double-blind, randomized controlled trial. Subjects are~     randomized to receive either 0.25% Bupivacaine or normal saline following their~     cardiothoracic surgery.~   "
41570|NCT02512848|"~     Investigators aim to collect endometrial sampling with Li Brush among target population who~     have risks for endometrial neoplasm, then Fractional curettage should performed with these~     participants, investigators intend to compare the pathological diagnosis results of cytology~     and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect~     that the brush can be used for screening of endometrial cancer in the postmenopausal period~     in the clinic.~   "
41571|NCT02512835|"~     Social determinants of health (e.g. the income, education, and environment of patients) may~     exert greater influence on health outcomes than traditional clinical factors (e.g. lab~     results, diagnoses, and family history). Calls for integrating primary care and public~     health are therefore increasing, but merging these domains of care is logistically~     difficult. Research is lacking on the incremental benefit of adding public health data at~     the practice level-- in improving either health outcomes or care delivery. This proof of~     concept pilot will merge data from electronic health records (EHRs) with community vital~     signs, a set of metrics that describes key community resources that affect health. The~     investigators will identify resource poor communities, or cold spots, based on four~     variables (education, poverty, life expectancy, and access to healthy foods) at the census~     tract level - referred to as a community vital sign. The hypothesis is that patients coming~     from cold spots are more likely to have worse health outcomes and that clinicians will~     deliver better care if they know a patient's community context and his/her specific social~     needs. This study will involve 12 primary care practices in Northern Virginia that care for~     more than 170,000 patients. Patient addresses will be geocoded for each practice and~     determine which patients reside in cold spots for each community vital sign. The variation~     for each community vital sign for each practice's patients will be calculated and a~     bivariate and regression analyses will be used to determine whether coming from a cold spot~     is associated with worse clinical quality metrics. 15 clinicians will be alerted when they~     see a patient from a cold spot, patients will complete a social needs survey, and clinicians~     will prospectively document through surveys whether such knowledge affects interpersonal~     interactions (such as time spent with patients and the use of clearer language) or clinical~     management (such as referrals to care coordination or community resources). By pragmatically~     integrating community vital signs into care, this innovative proposal will seek to~     understand which community data clinicians value, how these data might influence care, and~     how best to incorporate these data into clinical and population care.~   "
41572|NCT02512822|"~     To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.~   "
41573|NCT02512809|"~     The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and~     serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement~     under isoflurane anesthesia.~   "
41574|NCT02512796|"~     Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known~     of its toxicity outside of patients with reduced renal function.~   "
41575|NCT02512783|"~     This is a double blind, randomized, controlled study. The sedationist performing the~     sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a~     placebo before the administration of Propofol. A research staff will observe the patient~     simultaneously with the induction of Propofol to determine the patient's pain level, as~     measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this~     study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the~     burning sensation caused by intravenous Propofol.~   "
41576|NCT02512770|"~     The aim of this study compares hemodynamic and respiratory changes and complications in~     children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only~     control.~   "
41577|NCT02512757|"~     This is a prospective, multi-center study to evaluate the diagnostic performance~     characteristics of the AminoIndex™ technology among patients at high risk for developing~     lung cancer as compared with standard lung cancer screening and diagnostic procedures~     including low-dose CT, high-dose CT, biopsy and histopathology.~   "
41578|NCT02512744|"~     Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing~     two different decannulation protocols:~        1. based on capping trials to decide decannulation,~        2. based on the aspiration frequency to decide decannulation time. High-flow conditioned~          oxygen therapy will be applied to all patients through the tracheal cannula. In~          patients included in the suctioning frequency based protocol along the study period and~          in patients included in the capping trial protocol along periods out of capping trials.~   "
41579|NCT02512731|"~     Delayed graft function (DGF) is defined as requirement for dialysis in the first week~     following kidney transplantation. DGF is a common complication occurring in 39% of the~     deceased donor renal transplants at the investigators' institution with significant cost and~     outcome implications. The 3 major risk factors for DGF are donor graft characteristics,~     recipient factors and perioperative management. The most easily modifiable of these factors~     is perioperative management, in particular intraoperative fluid therapy. The investigators~     propose to compare the amount of fluid administered using the current standard of care with~     the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler~     Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta,~     optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid~     administration fails to produce an increase in CO.~   "
41580|NCT02512718|"~     Children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders~     frequently develop gastrointestinal, metabolic and infectious complications related to~     preparative high-dose chemotherapy and/or radiation-related toxicity. Parenteral nutrition~     (PN) with lipid emulsion is commonly required while gastrointestinal complications preclude~     adequate oral or enteral intake. PN and lipids may increase the risk of metabolic and~     infectious complications in HCT patients who are inherently immune compromised.~      Supplementation with omega-3 fatty acids has been linked to improvements in outcomes in~     several populations. Provision of fish oil lipid emulsion (FOLE), rich in omega-3 fatty~     acids, to children undergoing HCT is an innovative nutritional strategy that could mitigate~     the metabolic and inflammatory side effects of HCT and its treatment. With its potential to~     safely maintain essential fatty acid status, normalize blood lipids and alleviate the~     inflammatory response to illness, the use of FOLE may reduce the risk of infections,~     regimen-related toxicity, and other morbidities after HCT.~      A randomized, controlled pilot study is proposed to test the safety and tolerability of~     FOLE, compared to standard lipid emulsion, in 20 children during hospitalization for HCT.~     Results of this study will provide the preliminary data needed for a larger clinical trial~     examining the effect of FOLE on important clinical outcomes in this population. This novel~     approach to nutritional care of this high-risk group will advance clinical knowledge of the~     impact of FOLE, and will support further investigation into nutritional adjuncts to~     pediatric cancer treatment.~   "
41581|NCT02512705|"~     The Psychiatric Emergency Services (PES) is an under researched area of clinical practice,~     largely in the management of acutely agitated and violent patients. The goal of this pilot~     randomized clinical trial (RCT) is to assess the benefit of medically monitoring patients~     that present with extreme agitation and/or violent behaviour to PES. Placing them in~     physical restraints and immediately administering chemical restraint, will enable medical~     monitoring of these potentially medically unstable patients. Investigators believe that this~     practice will provide safer management of patients, reduce risk to staff and other patients,~     reduce risk of undiagnosed medical conditions that underly the agitation, and increase~     clinical management and quality of care. Patients that come into the Emergency Department~     that are agitated and violent, where verbal-deescalation will not suffice, will be randomly~     treated with either immediate placement in seclusion (current practice) or be placed in~     physical restraints and given chemical restraint (as outlined in the BETA project~     guidelines). The same time interval assessments will be performed on both groups of patients~     including; medical monitoring and agitation scale assessment. Data will also be collected on~     number of violent episodes, code whites, required increase in the use of physical~     restraints, length of intervention, and more. This assessment will enable a comparison~     between the current practice and the proposed practice to establish evidence based clinical~     guidelines for the management of acute agitation in PES, where de-escalation techniques are~     ineffective and the lack of medical monitoring is harmful to the patient and can negatively~     effect their outcome. In order to best assess the importance of medical monitoring for such~     patients, a pilot study must be performed to assess the feasibility of such a phase III RCT~     study.~   "
41582|NCT02512692|"~     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90~     Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable~     intrahepatic cholangiocarcinoma (ICC).~   "
41583|NCT02512679|"~     Many genetic diseases of lymphohematopoietic cells (such as sickle cell anemia, thalassemia,~     Diamond-Blackfan anemia, Combined Immune Deficiency (CID), Wiskott-Aldrich syndrome, chronic~     granulomatous disease, X-linked lymphoproliferative disease, and metabolic diseases~     affecting hematopoiesis) are sublethal diseases caused by mutations that adversely affect~     the development or function of different types of blood cells. Although pathophysiologically~     diverse, these genetic diseases share a similar clinical course of significant progressive~     morbidity, overall poor quality of life, and ultimate death from complications of the~     disease or its palliative treatment. Supportive care for these diseases includes chronic~     transfusion, iron chelation, and surgery (splenectomy or cholecystectomy) for the~     hemoglobinopathies; prophylactic antibiotics, intravenous immunoglobulin, and~     immunomodulator therapies for the immune deficiencies; and enzyme replacement injections and~     dietary restriction for some of the metabolic diseases. The suboptimal results of such~     supportive care measures have led to efforts to implement more aggressive therapeutic~     interventions to cure these lymphohematopoietic diseases. The most logical strategies for~     cure of these diseases have been either replacement of the patient's own hematopoietic stem~     cells (HSC) with those derived from a normal donor allogeneic bone marrow transplant (BMT)~     or hematopoietic stem cell transplant (HSCT), or to genetically modify the patient's own~     stem cells to replace the defective gene (gene therapy).~   "
41584|NCT02512666|"~     This research study is looking at a small device that measures white blood cell (WBC) counts~     by being placed against the finger nail for participants who are undergoing stem cell~     transplantation at Massachusetts General Hospital or have a hematologic malignancy and are~     being seen as an outpatient.~   "
41585|NCT02512653|"~     Biological Standardization of Cupressus arizonica Allergen Extract.~   "
41586|NCT02512640|"~     Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have~     been reported in some literatures. There are no studies investigating the time course of~     changes in oxidative stress markers in volume-controlled ventilation (VCV) and~     pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the~     alterations in oxidative stress in two different ventilation strategies during gynecologic~     laparoscopic surgery.~      Methods:~      Fifty-two patients of ASA physical status I or II were randomly assigned to receive either~     VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation~     variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood~     samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute~     before (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and~     120 minutes after deflation (T3~T6); and 24 hours after deflation (T7).~   "
41587|NCT02512627|"~     This study aims to investigate and compare the intervention effects of combining exercise~     and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in~     elderly with mild cognitive impairment. The investigators hypothesize that (1) both~     sequential and dual-task training can induce greater improvements in the outcome measures~     than single mode of training; (2) the improvement in cognitive functions and other outcomes~     may differ between the groups.~   "
41588|NCT02512614|"~     In March 2012, the investigators initiated a prospective, cluster-randomized, controlled~     field trial in Kisumu County, located in an area in western Kenya which has the highest~     under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The~     study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter~     referred to as towel) in preventing diarrheal diseases, acute respiratory infections,~     self-reported fever, and skin infections in children <2 years old.~   "
41589|NCT02512601|"~     This study aims to evaluate whether, in a standardised cohort of patients with mild to~     moderate PTS, monitored for a sufficiently long follow-up period, quality of life measured~     by generic instruments and disease-specific instruments evolves favourably in this patient~     profile.~      Study objective: to evaluate the evolution of quality of life in general and in the specific~     context of the disease of patients who have experienced an episode of deep-vein thrombosis~     (DVT), are affected by post-thrombotic syndrome, are subject to compression therapy and~     receive an additional standard venoactive agent (sulodexide 15 mg twice daily during 6~     months).~   "
41590|NCT02512588|"~     This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple~     crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy~     without cataplexy (Type 2).~   "
41591|NCT02512575|"~     This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled,~     single ascending dose sequential group study in healthy male subjects. The objectives are to~     study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis~     (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid~     receptor modulator (SGRM). The study will also assess the safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with~     high doses of AZD9567 and placebo.~   "
41592|NCT02512562|"~     This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102~     and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.~   "
41593|NCT02512549|"~     This study is a randomized parallel group controlled trial which aims to study the effects~     of pulmonary rehabilitation intervention on exercise capacity and quality of life in~     patients with severe COPD as compared to standard medical care. The expected duration is one~     and a half years with effect from 1st July, 2015 and will include 80 patients, 40 in each~     arm.~   "
41594|NCT02512536|"~     Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen~     both in primary and secondary care. It is a painful condition, with significant disability.~     Specialist shoulder replacements have found acceptance within the trust, nationally and~     internationally although there are high complication rates. There is however a significant~     cost difference (fifty fold) between a reverse total shoulder replacement and a botox~     injection, and to date there have been no randomised control trials, or any registered,~     comparing the use of a botox injection for pain relief in cuff arthropathy versus no~     treatment. If there is a significant clinical difference in the pain outcomes between the~     two, this could result in significant savings to the NHS and the taxpayer as a whole. If~     high levels of pain relief could be predictably obtained using Botulinum A toxin injections~     then potentially patients could avoid the need for surgery.~   "
41595|NCT02512523|"~     This is a randomized, double-blind, active control, parallel group, exploratory phase 4~     study to compare the effect of teneligliptin versus sitagliptin on glucose variability when~     added on to metformin in patients with inadequately controlled type 2 diabetes mellitus.~   "
41596|NCT02512510|"~     The purpose of this study is to measure the effectiveness and safety of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to placebo, a treatment without activity.~   "
41597|NCT02512497|"~     The goal of this clinical research study is to learn if giving romidepsin before and after a~     stem cell transplant in combination with fludarabine and busulfan can help to control~     leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of~     romidepsin that can be given with this combination.~      The safety of this combination and the safety of giving romidepsin after a stem cell~     transplant will also be studied.~   "
41598|NCT02512484|"~     Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not~     have a general practitioner (GP) registration and their only interaction with the NHS is via~     Accident and Emergency (A&E) Departments of hospitals. This is often the case for those in~     hard to reach groups, who are also those often at highest risk of TB. This study seeks to~     assess whether A&E Departments are effective sites for the identification and onward~     management of TB, both in its latent and active forms.~   "
41599|NCT02512471|"~     The aim of this study is to determine the minimum effective volume of local anesthetic~     (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB~     for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in~     middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb~     distal to the shoulder.~   "
41600|NCT02512458|"~     This is a prospective, open-label, single arm translational study of cabazitaxel in bone~     Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated~     with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice~     for up to 10 cycles or until disease progression or unacceptable toxicity or physician's~     decision or patient's consent withdrawal (whichever occurs first).~   "
41601|NCT02512445|"~     The goal of this project is to determine if a 6-session psychotherapy intervention will help~     Veterans feel less deployment-related guilt and less distress related to their guilt. Half~     of the participants will receive the guilt focused intervention and half will receive a~     supportive intervention.~   "
41602|NCT02512432|"~     To join established study put on by Addition Technologies, Inc. in the surgical implantation~     of asymmetrical INTACS segments to treat myopia and astigmatism in patients with~     keratoconus.~   "
41603|NCT02512419|"~     The aim of this study is to build upon our tailored print intervention by developing new~     text-delivered intervention materials to complement our print-based physical activity (PA)~     intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American~     (MA) men to determine content, frequency, and types of text messages desired, and to~     identify cultural themes to incorporate into existing and new materials. Themes from the~     focus groups and sample text messages will be presented to a confirmatory focus group panel.~     Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60)~     to test the text-enhanced, Spanish language, individually tailored PA intervention vs.~     publicly available, Spanish language health education materials, including information on~     PA, diet, and stress management. This will be followed by post-intervention qualitative~     interviews to solicit suggestions for improvements to help further refine the program. The~     proposed pilot will support a future R01 to establish the efficacy of this multi-media,~     multi-level PA intervention for Mexican and MA men.~   "
41604|NCT02512406|"~     The purpose of this study is to learn more about how patients with Tourette Syndrome deal~     with sensory stimuli in their environment such as bright lights, loud noises, physical~     sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette~     Syndrome to those without Tourette Syndrome.~      The study aims to better characterize sensory processing abnormalities by sensory modality:~     The investigators will use a measuring tool based on Dunn's 1997 model of sensory~     processing, the Sensory Profile, which will allow the investigator to characterize both~     registration and response to external stimuli, as well as to delineate which sensory~     modalities are affected. Identifying which sensory modalities are most affected may guide~     future research into the pathophysiology of sensory processing abnormalities in TS.~      The investigators also aim to correlate sensory processing abnormalities with the presence~     of Obsessive Compulsive Disorder (OCD), Attention-deficit/hyperactivity disorder (ADHD) ,~     and autism spectrum disorders.~   "
41605|NCT02512393|"~     The purpose of this research is to study the effects of Transcranial Direct Current~     Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a~     better understanding of the factors that cause pain and disability in people with knee~     osteoarthritis (OA). In particular, people from different ethnic and racial groups may~     experience OA pain differently which is why the focus will be on older Asian Americans and~     non-Hispanic whites. It is important to find a reason for such difference so that a better~     treatment can be found for all OA patients. In addition, the research study will examine if~     there is any ethnic differences in pain and mobility disability. The investigator~     hypothesize that Asian Americans will report greater pain and mobility disability than~     non-Hispanic whites, and that active tDCS will result in improvement in pain and disability~     compared to sham tDCS.~   "
41606|NCT02512380|"~     gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of~     this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel~     (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable~     gastric/esophagogastric junction (EGJ) cancer.~   "
41607|NCT02512367|"~     There are few disease prevention programs or programs to manage somatic disorders in a~     psychiatric context. The aim of this study is to evaluate the impact in the medium term of a~     global program to promote dental health on buccodental hygiene in patients with~     schizophrenia and the ability of these patients to follow the intervention.~      This is an interventional trial, randomized in clusters. The participating establishments~     will be randomized to the intervention group (promotion program) or the control group~     (surveillance).~      For each patient, the study will last 12 months altogether and will include an initial~     evaluation of dental health, a 6-month education program for dental care (for patients in~     the intervention group) and a follow-up at 6 and 12 months after the start of the study.~     The follow-up will evaluate dental health and quality of life.~   "
41608|NCT02512354|"~     This research concerns the contribution of a new examination, high-throughput exome~     sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With~     currently available examinations, the causes of polyformative syndromes, which correspond to~     the association of several congenital malformations with varying degrees of severity in~     different organs, remain unknown in a large number of cases.~      High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous~     analysis of all of the coding parts of DNA. This examination has already shown its superior~     diagnostic capability in every post-natal diagnostic context, in particulier in infants with~     malformations associated or not with intellectual deficiency. Its contribution has not yet~     been studied in a large number of fetuses with polymalformations. To investigate the~     usefulness of HTES, we propose to carry out the examination in 100 fetuses with~     polymalformations, as well as the usual examinations including chromosomal microarray~     analysis and possibly the study of specific genes that may explain these malformations. A~     blood sample will be taken from both parents to allow interpretation of the results.~   "
41609|NCT02512341|"~     The purpose of this preliminary clinical study is to assess the quality of a computational~     algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either~     pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.~      Each patient is auscultated and diagnosed independently by a medical specialist by means of~     a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a~     Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm.~     An echocardiogram is performed as the gold-standard for determining heart pathologies. The~     results of the computer aided auscultation (CAA) are compared to the findings of the medical~     professionals as well as to the echocardiogram findings.~      Hypothesis: The specific CAA algorithms used in this study are able to differentiate~     pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric~     population.~   "
41610|NCT02512328|"~     Feasibility of an newly programmed offline application for smartphones (SPA, APP) for~     colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and~     behavioral recommendation.~   "
41611|NCT02512315|"~     The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays~     is concurrent chemoradiation (CRT) based on intensity-modulated radiation therapy (IMRT).~     However, distant metastasis remains the major cause of treatment failure, especially in~     patients with T1-4N2-3M0 diseases (N2-3 NPC). The investigators inferred that it was more~     appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT of~     sufficient intensity such as 4 cycles might be effective enough for control of the~     pre-existing micrometastases. Therefore, the objective of this phase 3 multicenter~     randomized controlled trial is to make a comparison between NACT of 4 cycles plus CRT based~     on IMRT and CRT alone in N2-3 NPC on distant metastasis, survival and adverse reaction.~   "
41612|NCT02512302|"~     The purpose of this research study is to determine the amount of medicine absorbed in the~     lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without~     activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease~     (COPD).~   "
41613|NCT02512289|"~     tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used~     in chronic stroke patients to improve a variety of functions with upper limb.~   "
46486|NCT02448550|"~     The purpose of this trial is to determine whether bivalirudin is non-inferior to~     unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment~     elevation myocardial infarction undergoing percutaneous coronary intervention.~   "
41617|NCT02512237|"~     This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum~     tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers~     with a human epidermal growth factor receptor 2 (HER2) test result that is in situ~     hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b~     designed to assess anticancer activity and safety in three expansion cohorts: two different~     advanced breast cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive~     or IHC3+ and for tumors that test as HER2 ISH negative with IHC 2+), and one advanced~     gastric cancer expansion cohort (for tumors that test as HER2 ISH positive or IHC3+).~   "
41618|NCT02512224|"~     Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally~     were compared and analyzed.~   "
41619|NCT02512211|"~     Spanish Validation of HAL and HEP questionnaire by double translation~     (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and~     parents of children with hemophilia. The final validity will be obtained with a sample of~     60-100 patients with hemophilia~   "
41620|NCT02512198|"~     This is a randomised controlled study to evaluate the effect of providing prescribing~     feedback that includes individual patient data to General Practitioners (GP) in Scotland on~     high risk or low quality prescribing.~   "
41621|NCT02512185|"~     This study will examine the impact of modern treatments for metastatic Castrate Resistant~     Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function,~     objective physical function, and falls. Additionally, the investigators study whether~     frailty is associated with worse outcomes, and whether it is possible to predict the risk of~     severe chemotherapy toxicity in older men.~   "
41622|NCT02512172|"~     This study is being done to test the safety and effectiveness of the combination of~     intravenous (IV) romidepsin and/or oral 5-azacitidine with IV MK-3475 in people with~     microsatellite stable (MSS) advanced colorectal cancer.~   "
41623|NCT02512159|"~     The aim of this study was to evaluate the efficacy of a handicraft topical device of~     negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in~     patients with diabetes mellitus, venous stasis and arterial insufficiency.~   "
41624|NCT02512146|"~     The study aims to determine the expression of the ionotropic glutamate receptors in colon of~     irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic~     glutamate receptors and IBS symptoms.~   "
41625|NCT02512133|"~     To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of~     microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus~     (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat~     primary open angle glaucoma (POAG).~   "
41626|NCT02512120|"~     Volume controlled ventilation(VCV) is a most common used ventilation mode during general~     anesthesia. But VCV can cause high airway peak pressure when patient under steep~     Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure~     and improve dynamic compliance. We will compare parameters(arterial blood gas analysis,~     airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.~   "
41627|NCT02512107|"~     The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice~     Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in~     an obese, stressed population.~      The microbiome and its component genes are long known as critical determinants of the~     nutritional value of the food we eat. Recently, it has become clear that the composition of~     this microbiome and its metabolites influences the host immune system, thereby altering host~     physiology. Both obesity and chronic stress have been shown to have an altered gut~     microbiome; both these conditions also lead to increased systemic inflammatory molecules~     that can lead to an increased risk for type 2 diabetes and other diseases caused by chronic~     inflammation.~      Juice Plus+ consumed by an overweight population combined with an eight week exercise regime~     showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS)~     and lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic~     cytokines are altered by the composition of the gut microbiome, this study proposes to~     determine if this decrease in inflammation by Juice Plus+ is due to a change in the species~     composition and metabolism of the microbiome. This question is particularly relevant for~     populations with high inflammatory loads resulting from excess weight in addition to~     increased psychological stress.~      The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome~     species composition and metabolism, 2) if there is an alteration in intestinal permeability~     with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic~     markers of inflammation and oxidative stress among individuals who are psychologically~     stressed and overweight. The investigators will use a randomized, placebo-controlled design~     with a cohort of overweight, female, critical care health care professionals. Subjects will~     receive the supplements or placebo for sixteen weeks. At the end of 16 weeks, the cohort~     receiving the supplement will be randomized to also receive a meal replacement component or~     follow their normal diet for an additional 4 weeks. Stool and a fasting blood sample will be~     collected at the beginning of the study (baseline) and 8, 16 and 20 weeks later. At each~     time point, subjects will also consume a cocktail of glucose, mannitol and lactulose and a~     second blood draw performed to look at absorption of these molecules.~   "
41628|NCT02512094|"~     Since an increasing in population age, there was an increasing in geriatric patients. Most~     of elderly patients needed rehabilitation programs to regain their quality of life during~     their medical treatments. Barthel index is a functional measurement to evaluate~     rehabilitation improvement in chronically-ill patients and also used for evaluation of~     patient's self-care.~      Barthel index had been translated into many languages and validated in many medical~     conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However,~     Barthel index had not been translated into Thai language and validated to use in hip~     fracture patients.~      The purposes of this study were to translate the Barthel index into Thai language and to~     assess validity and reliability of Thai version Barthel index in hip fracture patients.~   "
41629|NCT02512081|"~     This will be an exploratory study, using semi-structured interviews to explore patients'~     experiences of undergoing investigations for Sciatica (leg pain referred from the lower~     back). Interviews will be analysed based on an Interpretative Phenomenological Approach~     (IPA).The end product of analysis will be a detailed account of patients' experiences~     supported by direct quotes.The intention is that this account will help health-care~     providers to understand patients' experiences and to plan and provide Sciatica care that is~     effective, evidence based and acceptable to patients.~   "
41630|NCT02512068|"~     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when~     administered at a dose of 25 mg once weekly using placebo as a control in patients with type~     2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure and~     inadequate glycemic control despite diet and/or exercise therapy (if given) or despite~     treatment with one other antidiabetic drug in addition to diet and/or exercise therapy (if~     given); and to evaluate the long-term efficacy and safety of SYR-472 when administered at a~     dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe~     renal impairment or end-stage renal failure.~   "
41631|NCT02512055|"~     Ketamine provides a safety zone for sedated but spontaneously ventilated children especially~     in remote conditions such as radiotherapy units where sedation is an essential practice for~     children to keep calm and motionless In this study, investigators planned to analyse~     ketamine doses needed and the recovery times in pediatric oncology patients undergoing~     repeated radiotherapy sessions.~   "
41632|NCT02512042|"~     This is a randomized, double blind, two-arm, parallel group, active controlled~     bioequivalence study, at multiple clinical trial sites designed to demonstrate~     bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies~     Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon~     Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in~     both eyes.~   "
41633|NCT02512029|"~     This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute~     traumatic brain injury.~   "
41634|NCT02512016|"~     The Motherhood and Pelvic health study (MAP), Bridging physical and cultural determinants of~     postpartum pelvic floor support and symptoms following vaginal delivery, uses mixed methods~     research to study the influences of intra-abdominal pressure, physical activity and strength~     on pelvic floor support and symptoms and the cultural context in which women experience~     those changes.~   "
41635|NCT02512003|"~     The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary~     Scaffold in native coronary arteries.~   "
41636|NCT02511990|"~     This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the~     antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in~     HIV-infected and HIV-uninfected individuals.~   "
41637|NCT02511977|"~     The control of biofilm around implants is critical to the success of the implant~     rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform~     and guide patients, and keep their maintenance in order to prevent pathological processes~     that can lead to the implanted component loss.The aim of the present retrospective~     longitudinal study was to evaluate through clinical periodontal parameters and radiographic~     images in dental implants rehabilitated with overdentures installed seven years ago.~     individuals who underwent the installation of dental implants for making full~     implant-supported upper and lower mucus dentures in the Department of Implant Dentistry,~     Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal~     parameters such as probing depth, plaque index, bleeding index and mobility as well as~     radiographic examination, are key to determine the correct diagnosis in dental implants. The~     control of biofilm around the implants seems to be a decisive factor for maintaining tissue~     health. We believe that the maintenance appointments are fundamental, but more studies~     should be conducted to elucidate microbial and immunological factors in implants placed and~     due for some time.~   "
41638|NCT02511964|"~     The objective was to determine the effect of six running sessions of high intensity interval~     training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of~     1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of~     training on performance in the different inclines.~   "
41639|NCT02511951|"~     The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure~     named One-layer duct-to-mucosa pancreaticojejunostomy in pancreatoduodenectomy, which~     could provide a feasible option to pancreatic surgeons for patients with~     pancreaticoduodenectomy.~   "
41640|NCT02511938|"~     This study will introduce healthy child menu items into 8 independent full service~     restaurants in San Diego County. The restaurants will be assigned either to receive new,~     healthy kids' menu items or to receive the new menu items in addition to marketing materials~     and staff trainings to support promotion of these new menu items. The primary outcome for~     the study is sales of kids' menu items. Additional customer observation and interview data~     will be collected, as well as manager interviews and restaurant environment assessments.~     Process evaluation measures will also evaluate the implementation of the intervention.~   "
41641|NCT02511925|"~     If patients acquire a new infection whilst in hospital this can cause significant morbidity,~     prolonged hospitalisation and even death. Indeed, there is much public concern about~     infections such as MRSA. Patients who require intensive care are probably at the greatest~     risk.~      Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal~     of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at~     only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance~     include lack of time, skin irritation, lack of facilities, intensity of workload and~     forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff~     may not associate their (lack of) actions with having caused harm.~      Measuring compliance levels enables staff to understand whether they could improve. Direct~     observation of staff is labour intensive and is not continuous or universal. We will monitor~     hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing~     Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise~     that comprehensive personalised feedback will reduce healthcare associated infections. We~     will undertake the study in three intensive care units.~   "
41642|NCT02511912|"~     This is a prospective, non-randomized, open label, single-arm multi-center study.~   "
41643|NCT02511899|"~     Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit~     powder on cutaneous microcirculation and endothelial function.~   "
41644|NCT02511886|"~     This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in~     the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving~     AP, one subject will receive placebo.~   "
41645|NCT02511873|"~     This is a Phase II, 2 arm randomized crossover study. Subjects will be assigned to either~     active agent or placebo and then crossover to the other arm. This study is designed to~     evaluate whether Fycompa improves the quality of life in patients with small fiber~     neuropathy.~   "
41646|NCT02511860|"~     This is a study of women aged 18-65, to determine the physiological effects of consuming~     burdock root in supplement form. Burdock has long been used by herbalists for its diuretic~     and blood sugar lowering properties.~   "
41647|NCT02511847|"~     [Background]: Triple-negative breast cancer (TNBC) is defined by a lack of expression of~     both estrogen and progesterone receptor as well as human epidermal growth factor receptor 2~     (HER-2). TNBC is characterized by distinct molecular, histological and unfavorable clinical~     features despite the high rates of response to chemotherapy. Based on the above reasons, it~     is important to emergently develop novel therapies and/or treatment strategies to increase~     treatment efficacies and the survival rate of TNBC.~      [Rationale]: Overexpression of epidermal growth factor receptor (EGFR/ErbB1) and EGFR~     mutation have been reported in TNBC and may therefore be a valid target for anti-tumor~     therapy in TNBC. Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits~     signaling from all relevant ErbB-family dimers. Afatinib has demonstrated preclinical~     activity in triple-negative breast cancer cell lines and xenograft models of breast cancer,~     and clinical activity in phase I studies. Based on the assumption that uncontrolled~     ErbB-signaling is directly related to an increased oncogenic potential in TNBC, the studying~     afatinib in the neoadjuvant treatment of TNBC patients is important and provides a novel~     therapy.~      [Aims] The primary endpoint is to evaluate the pathologic complete response of the~     combination of afatinib and weekly paclitaxel in TNBC patients receiving neoadjuvant~     treatment. The secondary endpoints are to evaluate the clinical response and safety of~     afatinib with and without paclitaxel, and to explore the different afatinib-affecting~     downstream molecular pathways as well as potential biomarkers predicting the response of~     afatinib with and without paclitaxel.~      [Patients and methods]: Patients with TNBC (clinical T2-T3, N0-N1, M0; clinical T1-3, N1-2,~     M0; or any T4a tumor) and received neoadjuvant treatment will included in this open, label,~     multi-center phase II study. Our schema is as follows: (1) Afatinib 40 mg per day for 14~     days, then evaluation, every subject will go into the following phase no matter whether she~     had response or not (2) the following phase (the combination with afatinib and paclitaxel):~     Afatinib 40 mg per day, day 1 to day 21, in combination with paclitaxel 80 mg/m² on days 1,~     8, 15 in a 3-weekly course. In addition to the clinical assessment, we will evaluate the~     potential predictive biological markers of activity of Afatinib with and without paclitaxel~     and dynamic changes of molecular makers ([serum and tissue samples: before treatment, 2~     weeks after treatment, and operation timing]; potential molecules, such as EGFR,~     EGFR-signaling, FGFR, FGFR-signaling, ERK, p53, NF-κB, and etc. were evaluated through the~     immunohistochemical stains, mutation analysis, mRNA [RT-PCR], single nucleotide polymorphism~     analysis, and FISH analysis). In addition, the genetic expression profiles will be compared~     between afatinib-responsive and afatinib-unresponsive samples.~      [Expected Results]: The promising clinical activity, tolerable toxicity, and potential~     biomarkers of afatinib with and without paclitaxel in TNBC patients receiving neoadjuvant~     setting will be demonstrated. The results from this study can be used to conduct a larger~     trial that would allow us to confirm or validate the hypotheses generated.~   "
46487|NCT02448537|"~     This research study is investigating a drug called PM01183 alone and in combination with~     chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic~     or unresectable Sarcoma.~   "
41648|NCT02511834|"~     Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective,~     multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi~     vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass~     grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the~     right territory and one or more SVGs to the left territory. Of all vein grafts, one will be~     selected randomly to receive treatment with VEST and another designated Control.~   "
41649|NCT02511821|"~     This pilot clinical trial studies an electronic monitoring device of patient-reported~     outcomes (PROs) and function in improving patient-centered care in patients with~     gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way~     of asking patients about the quality of life, symptoms, and activity using online surveys~     and an activity tracking watch may make it easier for patients to tell their doctors and~     nurses about any issues before and after surgery. Electronic systems of assessing PROs may~     increase the depth and accuracy of available clinical data, save administrative time, prompt~     early intervention that improves the patient experience, foster patient-provider~     communication, improve patient safety, and enhance the consistency of data collection across~     multiple sites.~   "
41650|NCT02511808|"~     The purpose of this study is to understand how certain interventions help people reduce or~     quit their drinking and how certain interventions may help best at certain points in time in~     the change process.~   "
41651|NCT02511795|"~     The purpose of this Phase 1b, multi-centre, dose escalation study is to find the maximum~     tolerated dose (MTD) of AZD1775 combined with olaparib in patients with refractory solid~     tumours~   "
41652|NCT02511782|"~     The aim of this study is to measure local inflammatory responses in patients undergoing an~     allogeneic stem cell transplant and attempt to define any set of biomarkers that are~     significantly altered in acute or chronic skin graft versus host disease.~   "
41653|NCT02511769|"~     The proposed study will determine whether the efficacy of WebMAP cognitive behavioral~     therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and~     explore whether the intervention is feasible and acceptable to this population. Feasibility~     of multi-institutional recruitment from sickle cell centers will also be determined. The~     short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a~     multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral~     intervention in a large population of youth with SCD. The long-term goal of this research is~     to develop effective, easily accessible, behavioral pain interventions for youth with SCD to~     reduce the long-term impact of pain on function, quality of life, and health service use in~     this population.~      The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized~     controlled trial design to test the acceptability and efficacy of the Web-MAP intervention~     in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1)~     Subjects will be randomized to either the behavioral intervention or the online patient~     education control group. The treatment protocol will be implemented over 8 weeks in~     Internet-based treatment modules. The primary study outcome is pain and functional~     impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.~   "
41654|NCT02511756|"~     The primary objective of this study is to investigate the anti-angiogenic effect of~     bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free~     survival (PFS) in mCRC patients under first-line bevacizumab-containing,~     fluoropyrimidine-based chemotherapy~   "
41655|NCT02511743|"~     The aim of this study was to evaluate knowledge and behavior of physicians regarding~     Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire~     assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection.~     These results provide data support for updating guidelines, continuing training, and even~     developing policies in medical insurance.~   "
41656|NCT02511730|"~     The purpose of this pilot is to provide credible performance estimate information in order~     to conduct subsequent reader studies.~   "
41657|NCT02511717|"~     Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence.~     This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin~     patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the~     treatment of women with clinical symptoms of overactive bladder.~   "
41658|NCT02511704|"~     The purposes of this study are 1) to determine the pharmacokinetics of nicotine after~     multiple dose administration by electronic cigarette and 2) to compare the acute effects of~     multiple dose of nicotine administrated by electronic cigarette compared with those obteined~     by cigarette.~   "
41659|NCT02511691|"~     Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be~     monitored in human brains.~   "
41660|NCT02511678|"~     This study will evaluate the efficacy of cryoablation for palliation of painful metastases~     in patients with metastatic lesions involving bone who have failed, are not candidates for,~     or are not experiencing adequate pain relief from current pain therapies (e.g. radiation,~     analgesics).~   "
41661|NCT02511665|"~     This is a randomized, placebo-controlled, double-blind, window of opportunity study~     investigating the biological mechanism of metformin in prostate cancer.~   "
41662|NCT02511652|"~     The aim of the study is to compare the performance of two supraglottic airway devices (SGA),~     the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic~     laparoscopy in the trendelemburg position.~      Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion,~     quality of ventilation, endoscopic view of the glottis, gastric tube passage and~     complications.~   "
41663|NCT02511639|"~     The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus~     with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic~     breast cancer.~   "
41688|NCT02511314|"~     The purpose of this study is to compare the use of an electronic incontinence identification~     system with nursing home support (Tena Identifi) versus usual care on the quality, resource~     use and outcomes of continence care for older residents of nursing care homes.~   "
41689|NCT02511301|"~     The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™),~     which is attached to soft biometric patches worn on the body, can improve early breast~     cancer detection along with mammography or as a stand alone device.~   "
41664|NCT02511626|"~     Endometriosis, one of the most common diseases of women during their reproductive period.,~     may present a chronic disabling disease with major impact on women's life. Therapeutic~     options are limited and recurrence of disease symptoms is frequent.~      The current study investigates the quality of life and several risk factors for the~     development of endometriosis as well as satisfaction with medical support in a minimum of~     600 women with different stages of endometriosis and the same number of control women~     matched for age (± 3 years) and nationality. To evaluate specific features of~     endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain~     not related to endometriosis is investigated. Recruitment takes place in different~     university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control~     women i.e. women without any evidence for endometriosis presenting for annual routine~     gynaecological controls are collected at the same places.~      A composition of different internationally validated questionnaires as well as specific~     questions on dealing with endometriosis is used to collect information on the quality of~     life and potential risk factors for endometriosis. Questions on sexuality and partnership~     are also distributed to women's partners. All diagnosis of endometriosis and classification~     of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's~     medical charts.~   "
41665|NCT02511613|"~     The purpose of this study is to evaluate anatomical and functional effect of combination~     therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with~     monthly ranibizumab intravitreal injections in patients with choroidal neovascularization~     due to AMD.~   "
41666|NCT02511600|"~     The goal of this clinical research study is to compare Progel® (a type of surgical sealant~     that is made from human blood products) to the standard of care (talcum powder) to learn if~     one method is better than the other for preventing air leaks in patients having a~     pleurectomy decortication.~   "
41667|NCT02511587|"~     FSME-Immun® is registered for application into the muscle. This study investigates if~     application under the skin leads to a comparable immune response.~   "
41668|NCT02511574|"~     The aim of this study is to compare the effectiveness between the cervical pessary and the~     natural progesterone in reduction of preterm birth rates in pregnant women with a uterine~     cervical length of 25 mm or less evaluated by transvaginal ultrasonography.~   "
41669|NCT02511561|"~     This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.~     Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study~     is designed to characterize safety, procedural factors and clinical effect of OTO-201~     administered in subjects with otitis externa.~   "
41670|NCT02511548|"~     The main objective of this study is to reach 80% circumcised men in a random sample of men~     living in the township of Orange Farm (South Africa).~   "
41671|NCT02511535|"~     Allergic patients especially those undergoing de-sensitization treatment have an altered~     immune responsiveness. The investigators aim to find out whether this influences immune~     responses to primary and booster vaccinations.~   "
41672|NCT02511522|"~     The purpose of this study is to see whether one dose of palliative radiation therapy~     directed to the liver in combination with standard BSC might help to reduce liver~     pain/discomfort due to cancer when compared to getting standard BSC alone.~   "
41673|NCT02511509|"~     Electroconvulsive therapy has been used in clinical practice since 1938, a number of~     randomized trials found significant differences favoring ECT in response rates between~     individuals with depression receiving real and sham ECT. Results of early studies performed~     on patients with schizophrenia weren't so clear, only few of these trials found appreciable~     differences between real and sham ECT in clinical outcome. The recent, more reliable studies~     have found that ECT is efficacious on different symptoms which might be present in the~     course of schizophrenia, for example, psychotic and affective ones, as well as suicidality.~     The serious complications of electroconvulsive therapy are rare, however, more frequent side~     effects may include cognitive impairment and postictal delirium. Thus, the researchers try~     to develop new, more effective and less harmful procedures of ECT, like bifrontal~     electrodes. The available studies revealed that bifrontal ECT has equal efficacy to~     bitemporal ECT with less cognitive impairment, but the literature examining this placement~     is limited to major depressive disorder and the results are inconsistent. In the worldwide~     literature there is lack of studies regarding the use of bifrontal ECT among patients with~     schizophrenia. It is interesting how bifrontal ECT would affect axial symptoms of~     schizophrenia, since the electrodes in this procedure are placed over the brain areas~     responsible for negative symptoms. This randomized, double blind study is going to assess~     whether the bifrontal ECT is more effective in the treatment of positive and negative~     symptoms of schizophrenia, has less harmful impact on the cognitive functions and decrease~     the frequency and severity of postictal delirium comparing to the bitemporal ECT. Moreover,~     as the first worldwide will assess the brain dopaminergic activity with the use of PET in~     the patients with schizophrenia after ECT and the impact of the ECT on the concentration of~     such neurotrophins as brain-derived neurotrophic factor-BDNF, neuron specific enolase-NSE~     and protein S100B.~   "
41674|NCT02511496|"~     This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV)~     infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.~   "
41675|NCT02511483|"~     This study is a randomized, double-blind, placebo controlled clinical trial. The main~     purpose of this study is to determine if postsurgical pain ratings are improved with~     treatment with oral Propranolol, and if the effectiveness of treatment can be modified by~     the presence or absence of SNPs (Single Nucleotide Polymorphism) associated with~     Cathecol-O-MethylTransferase (COMT) and mu-opioid receptor (MOR1) activity. The treatment~     period will last for three days and the observation period will last for six months.~     Effectiveness of treatment will be assessed by means of morphine consumption through~     quantitative evaluation of IV-PCA (Patient Controlled Analgesia) morphine as primary outcome~     measure.~   "
41676|NCT02511470|"~     The purpose of this study is to determine if the use of a metronome improves chest~     compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric~     manikin.~   "
41677|NCT02511457|"~     Measurement of the cardiac output is one of the important hemodynamic monitoring tools in~     cardiac surgery. It helps determine the type of medications needed to maintain optimal~     hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary~     artery catheter is considered has the gold standard for the measurement of cardiac output.~     Investigators would like to compare the most popular minimally-invasive devices used to~     measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution~     method at various phases of the cardiac surgery.~   "
41678|NCT02511444|"~     The purpose of this study is to evaluate the test characteristics of a rapid intrapartum~     real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the~     standard in preterm patients presenting with threatened preterm labor or with obstetric~     indications for preterm delivery.~   "
41679|NCT02511431|"~     Background:~      - Chronic hepatitis D is a liver disease caused by the hepatitis D virus. It can be severe~     and progressive. Most people with hepatitis D will develop scarring and damage to the liver.~     There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the~     drugs lonafarnib and ritonavir can help people with chronic hepatitis D.~      Objective:~      - To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and~     effective.~      Eligibility:~      - People 18 years of age and older with chronic hepatitis D. They must not have HIV or other~     major illnesses.~      Design:~        -  Participants will be screened with medical history, physical exams, and blood tests.~        -  Participants will have 24 weeks of treatment. They will then have 24 weeks of~          follow-up.~        -  Participants will be in 1 of 6 treatment groups. Those in each group will receive~          different doses of the study drugs. Some groups will start with placebo but will~          receive treatment after 3 months of placebo.~        -  Participants will also take drugs to treat hepatitis B.~        -  Participants will have many visits. These will include:~        -  One three-day stay at the Clinical Center~        -  Physical exams~        -  EKG: small sticky patches will be put on the chest, arms, and legs to trace heart~          rhythm~        -  Ultrasounds of the abdomen~        -  Urine and blood tests~        -  Stool samples~        -  Eye exams~        -  Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may~          provide a sperm sample (optional).~   "
41680|NCT02511418|"~     This study was done to determine whether Simvastatin (a medication commonly used to treat~     patients with high cholesterol levels in the blood increases blood flow to the kidneys and~     improves renal function in normal volunteers and patients with impaired renal function~     secondary to polycystic kidney diseases.~   "
41681|NCT02511405|"~     The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111~     plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.~   "
41682|NCT02511392|"~     Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive~     stimulation methods that became widely used as therapeutic tools in neuropsychiatric~     research. The aim of this study is to Evaluate the therapeutic impact of different~     frequencies of repetitive transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and~     Methods; Forty five patients of OCD were participated in the study. All patients fulfilled~     the diagnostic criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each~     patient was subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS),~     Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression - Severity scale~     (CGI-S). The patients were randomly classified into three equal groups using closed envelop:~     1st group received 1 Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with~     intensity of 100% of the RMT and 3rd group was sham group received the sham stimulation with~     a total 2000 pulses every day for each group for 10 sessions. Follow up of the patients~     using the same previous scales after the end of sessions and 3 months later.~   "
41683|NCT02511379|"~     The purpose of this study is to evaluate the efficacy and safety of Systane® Balance~     following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. This study~     will be conducted in India.~   "
41684|NCT02511366|"~     The appearance of intact macronutrients in the small intestine induces an intestinal brake;~     a negative feedback mechanism from different parts of the intestine to the stomach, the~     small intestine and to the central nervous system. These processes inhibit food processing,~     appetite sensations and food intake, and furthermore they increase feelings of satiety and~     satiation. Several studies showed that intraileal infusion of nutrients resulted in a~     reduction in food intake. However only acute effects were investigated in these studies and~     thus far it is not known whether repetitive (intermittent) infusion results in adaptation to~     repeated exposure and, thus, a lowered ileal brake response.~   "
41685|NCT02511353|"~     In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to~     40% in 2008, where it has now stagnated. Innovative approaches are needed to continue~     towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used~     for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg.~     Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito~     survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its~     mosquitocidal effects. Previous studies have shown ivermectin is very well tolerated and~     safe even up to 2,000 mcg/kg. This dose finding study will evaluate the transmission~     blocking effect of high-dose ivermectin to define the optimal dose for future use of~     ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug~     administration (MDA). It explores a research question of global relevance. A prolonged~     transmission blocking effect of ivermectin could have substantial consequences for malaria~     control in the next decades. The results are expected to inform national malaria control~     programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the~     regulatory process.~   "
41686|NCT02511340|"~     Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib~     in accelerated or blastic Phase chronic myelogenous leukemia patients.~   "
41687|NCT02511327|"~     Young infants are most vulnerable to severe disease and even death when infected with~     Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee~     protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are~     transferred actively to the fetus. Administration of a pertussis containing vaccine during~     pregnancy offers protection through high titers of maternal antibodies transferred to the~     child. Since transplacental transport is immature, infants who are born prior to 37 weeks of~     gestation, might be vulnerable to pertussis infection even though maternal vaccination was~     administered, but specific data are lacking. The primary aim of this observational study is~     to measure whether vaccination during pregnancy offers protection to preterm born infants~     through higher titers of maternal antibodies, despite immature transplacental transport.~     Four cohorts of mother-infant pairs will be recruited: term versus preterm born infants,~     born from either vaccinated women or not vaccinated women. These mother-infant pairs are~     recruited according to the vaccination status of the mother and to the gestational age at~     delivery. Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous~     haemagglutinin, anti-Pertactin titers) will be monitored in blood samples of the mothers at~     delivery to measure the possible influence of both gestational age and maternal vaccination~     status. In order to measure the decline of maternal antibodies in the first weeks of life,~     blood will be taken from cords as well as from infants at 8 weeks of age, before the first~     infant pertussis vaccine is administered.~      Pertussis antibodies to the same antigens will be measured in all infants after a primary~     series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before~     and after a booster dose in the second year of life.~      In addition, cellular mediated immune responses will be evaluated in a subgroup of infants~     before and after a primary series of infants vaccines. A last goal is to measure whether~     vaccination during pregnancy could offer additional maternal antibodies through breast milk.~     Again a comparison is made between preterm and term born infants, born from either~     vaccinated or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA~     in breast milk samples will be measured in samples taken at birth (colostrum), and at~     several time points afterwards as long as breastfeeding is continued.~   "
41690|NCT02511288|"~     The goal of this project is to create a biological collection of blood samples from patients~     with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.~   "
41691|NCT02511275|"~     Surgery plays a central role in kidney cancer management being the only therapy that offers~     the possibility of healing the patients. Currently, the partial nephrectomy is a standard~     technique because it meets the principle of nephron sparing surgery. A partial nephrectomy~     requires a control of the renal blood flow using a clamp, which can be parenchymal or~     vascular (pedicular). In France, most of the centers use pedicular clamping. It is well~     established that this technique results in warm ischemia of the entire healthy parenchyma~     and can lead to permanent kidney damages. Currently, no study evaluated the impact of~     parenchymal clamping on the healthy parenchyma.~      The aim of the investigators study is to evaluate the nephrotoxicity of the healthy~     parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be~     done through a microdialysis technique. The microdialysis probe is directly implanted in the~     healthy unclamped parenchyma and will allow us to measure in real time, during the surgery,~     the biological changes related to anaerobic metabolism of renal interstitial space. All~     those measures will be completed by urinary and plasmatic assessments. Oxidative stress will~     be assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury~     Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and~     four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.~      This is a prospective pilot study limited to 10 patients included over 12 months. Depending~     on the results, it will be further developed by a second study comparing parenchymal with~     pedicle clamping.~   "
41692|NCT02511262|"~     The objective of this Clinical Trial is to define the methods to be used to document that~     illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument,~     with throat swab samples collected from symptomatic patients.~   "
41693|NCT02511249|"~     While perinatal ischemic stroke is the most frequent form of childhood stroke, early~     determinants of outcome remain poorly understood. Two main structural biases limit the~     accuracy of most studies: heterogeneity of the population and short follow-up.~      Perinatal ischemic stroke includes several conditions that differ in pathophysiology and~     timing of occurrence. Yet, it is not surprising that risk factors and outcome depend~     primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal~     insult. Even though the original lesion is static and focal in perinatal stroke, its~     consequences grow over time within the maturing brain and affect all fields of~     neurodevelopment.~      The objective of the AVCnn study was to delineate the determinants, clinical and imaging~     presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal~     arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the~     opportunity to regularly monitor a large cohort of children having suffered an NAIS.~   "
41694|NCT02511236|"~     The importance of reducing tobacco-associated health disparities between cannot be~     understated. Racial/ethnic minorities are less likely to quit, and tend to have elevated~     stress and depressive symptoms, which may contribute to cessation disparities. Cognitive~     behavioral therapy (CBT) for cessation addresses these concerns and has the potential to~     reduce/eliminate disparities. Preliminary research found racial/ethnic differences in~     baseline perceived stress and depressive symptoms. Following CBT, these differences were no~     longer present. Moreover, compared to Whites, African Americans exhibited blunted~     hypothalamic-pituitary-adrenal (HPA) axis functioning. This randomized controlled trial~     (RCT) will be the first to test the impact of CBT on smoking cessation disparities. The~     specific aims are to: (1) Examine the effects of CBT on perceived stress and depressive~     symptoms in a racially/ethnically diverse sample; (2) test the efficacy of CBT for~     eliminating smoking cessation disparities; and (3) examine physiological distress as an~     underlying mechanism for the effects of CBT on racial/ethnic minority smokers (exploratory).~     It is hypothesized that CBT will eliminate racial/ethnic differences in distress symptoms~     compared to the general health education (GHE) control group. A condition and race/ethnicity~     interaction on 7-day point prevalence abstinence (ppa) is also expected, with no~     racial/ethnic differences in cessation in the CBT condition only. It is also hypothesized~     that HPA functioning will mediate the effect of CBT on smoking cessation, particularly among~     racial/ethnic minorities. This study has implications for eliminating disparities in~     psychosocial factors related to cessation, and disparities in success. Addressing stress and~     depressive symptoms through CBT may facilitate cessation, particularly among racial/ethnic~     minorities.~   "
41695|NCT02511223|"~     This is an open label, single arm, phase II trial of Olaparib for PDAC patients with~     BRCAness. All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily.~     Treatment will continue until progression, intolerable toxicity or as per patient~     preference.~      Primary objective:~      To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal~     adenocarcinoma (PDAC)with BRCAness (BRCA-Breast Cancer susceptibility gene).~   "
41696|NCT02511210|"~     The researchers aimed to investigate that preoperative anxiety scores of patients who are~     informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and~     Amsterdam preoperative anxiety and information scale tests together.~   "
41697|NCT02511197|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung~     injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq~     68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with~     LI/PF. Visual and semiquantitative method will be used to assess the PET/CT images.~   "
41698|NCT02511184|"~     The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum~     tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and~     anti-tumor activity of the combination.~   "
41699|NCT02511171|"~     The aim of this research is to assess the acceptability of using a mobile folding screen for~     blinding parents of infant study participants in clinical trials of osteopathic~     interventions. The preliminary data of this acceptability study will inform future~     randomized controlled trials with infant participants where parental blinding is required.~     30 excessively crying infants will be randomly allocated to 2 groups, one group receives~     osteopathic intervention, the other group does not receive treatment. All infants are~     treated (or not) behind a mobile folding screen, so that parents are not aware of group~     allocation. After a 'treatment' period of 20 min, the screen is removed, and parents are~     asked to fill in an acceptability and blinding success questionnaire.~   "
41700|NCT02511158|"~     In this study we will examine patients who have undergone anterior cruciate and/or posterior~     cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury,~     contralateral tear and functional outcomes at least two years after surgery.~   "
41701|NCT02511145|"~     Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy~     volunteers to compare the effect on MAL penetration into the skin following various~     mechanical penetration enhancement techniques.~   "
46701|NCT02445742|"~     Prospective, open label, multicenter, phase II study evaluating correlation of SNPs with~     efficacy and toxicity in patients treated with Bosutinib. A total of 50 patients with~     previously treated Ph+ chronic phase CML will be included in the study~   "
41702|NCT02511132|"~     This is a multicenter, 1:1 randomized Phase IIb study of intradermal autologous Vigil™~     cancer vaccine in patients with metastatic Ewing's sarcoma Family of Tumors (ESFT)~     refractory or intolerant to at least 2 prior lines of chemotherapy. Patients undergoing a~     standard surgical procedure (e.g., tumor biopsy or palliative resection) may have tumor~     tissue harvested for manufacture of investigational product. Patients meeting eligibility~     criteria will be randomized to receive either (1) intradermal Vigil every 28 days for 4-12~     administrations, or (2) gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and D8 and docetaxel 75~     mg/m2 IV D8 every 21 days. The primary trial objective is to determine the overall survival~     of patients treated with Vigil™ versus gemcitabine/docetaxel.~   "
41703|NCT02511119|"~     The aim of this study is to develop a predictive model of risk of developing melanoma. The~     investigators will used artificial intelligence techniques to analysed images patterns~     obtained by clinical and dermoscopic pictures. The investigators want to defined a new~     predictive risk model obtained from genetic information and image analysis of pigmented~     lesions. This model could help to discriminate more accurately those patients who are most~     likely to develop melanoma in a high-risk population.~   "
41704|NCT02511106|"~     To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal~     Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma,~     following complete tumour resection with or without adjuvant chemotherapy.~   "
41705|NCT02511093|"~     The purpose of this study is to determine whether a team-based care (TBC) intervention,~     combining physician, nurse and pharmacist care improves BP control compared to usual care at~     6 months among outpatients with uncontrolled hypertension.~   "
41706|NCT02511080|"~     Using the spot-on device for monitoring core body temperature during colon laparoscopic~     surgery and prevent non-therapeutic hypothermia.~   "
41707|NCT02511067|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of~     Ranibizumab and Tocilizumab alone and in combination in eyes with Diabetic Macular Edema.~   "
41708|NCT02511054|"~     Background:~      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito~     that carries the parasite bites them. Although malaria does not occur in the United States,~     many people in Africa, Asia, and South America do get malaria. In some cases, malaria can~     cause death. In 2013 alone, 584,000 people died due to malaria. Researchers want to find~     ways to prevent and treat malaria.~      Objective:~      - To find out if combining live, infectious malaria parasites (known as Sanaria PfSPZ~     Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] and~     chloroquine [CQ]) is safe and can provide people protection against malaria. The Sanaria~     PfSPZ Challenge has been used in other studies without significant side effects.~      Eligibility:~        -  Healthy people ages 18-50 who weigh less than 170 pounds and are not pregnant or~          breastfeeding~        -  No history of hepatitis B, hepatitis C, or HIV infection~        -  Not currently enrolled in a clinical trial that involves a research drug or vaccine~        -  Have not traveled to an area with high malaria transmission within the last 5 years~        -  Never diagnosed with malaria in the past~      Design:~        -  Participants will be in 1 of 4 groups.~        -  Participants will receive a combination of injections and drugs. What combination they~          will receive will depend on what group they are in. This combination of injections and~          drugs may include:~             -  Injections of Sanaria PfSPZ Challenge (live, infectious malaria parasites) into a~               vein~             -  FDA approved antimalarial drug called chloroquine (CQ)~             -  FDA approved antimalarial drug called pyrimethamine (PYR)~             -  FDA approved antimalarial drug called Malarone~             -  The study will last approximately 3-7 months (depending on which group~               participants are in).~        -  There will be up to 68 study visits for three groups. One group will have up to 27~          study visits. During the study visits, participants may have:~             -  Medical history review~             -  Physical exams~             -  Electrocardiogram (ECG): soft electrodes will be placed on the skin. A machine~               will record the heart s electrical signals to evaluate heart function.~             -  Blood and urine tests~             -  Medication given in the clinic under direct observation~             -  Injection of Sanaria PfSPZ Challenge into a vein~             -  Participants will receive a diary, thermometer, and ruler to record their body~               temperature and any symptoms.~   "
41709|NCT02511041|"~     Background:~      - A congenital disorder of glycosylation (CDG) affects the cells that make up the organs and~     tissues. In these cells, sugar molecules do not properly attach to other molecules, which~     are the basic building blocks of cells. Changes in sugars seen in people with CDGs may lead~     to allergies and can change people s ability to fight infections. Researchers want to see if~     a sugar supplement called N-acetylglucosamine can help people with CDGs who have detectable~     changes in their immune systems.~      Objective:~      - To see if N-acetylglucosamine can help cells to function in a healthy way in people with~     CDGs.~      Eligibility:~      - People at least 2 years of age who have a CDG and immune system changes.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  One month later, participants will repeat the blood tests from the screening visit.~          Blood will be drawn on 2 different days in the same week.~        -  Participants will get N-acetylglucosamine supplements and instructions for how to take~          them. N-acetylglucosamine is a powder that can be added to food or drink.~        -  Participants will have a physical exam and blood tests every month during the study.~        -  After taking N-acetylglucosamine for about 4 months, participants will have more blood~          tests. They will get more N-acetylglucosamine supplements and a nucleoside supplement.~          The second supplement may be a powder or tablets that may be crushed and added to food.~          Participants will take both supplements for 5 months.~        -  After about 10 months in the study, participants will have 2 more visits in the same~          week for the same blood tests.~   "
41710|NCT02511028|"~     Background:~      - Contrast agents help things show up better on magnetic resonance imaging (MRI) scans.~     Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to~     determine that it does not cause prolonged MRI changes in the brain and to see if it helps~     identify inflammation in multiple sclerosis~      Objective:~      - To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS).~      Eligibility:~        -  Adults ages 18 55 who have MS.~        -  Healthy volunteers ages 18 55.~      Design:~        -  Participants will have 5 clinic visits over 6 months.~        -  Participants will be screened with a medical history, neurological exam, and blood~          draw. Full clinical measures will be obtained.~        -  Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast~          agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie~          on a table that can slide in and out of the cylinder.~        -  During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that~          is inserted with a needle into a vessel in the arm.~      <TAB>- Participants will then have a 7 tesla MRI scan of the brain..~        -  At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and~          have blood drawn. The MRIs may include gadolinium.~        -  Participants may have a full neurologic exam at these visits. At the final visit, full~          clinical measures will be obtained.~        -  Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the~          brain.~   "
41711|NCT02511015|"~     Background:~      - Parkinson s disease is a disease of the nervous system that affects movement. People~     usually get it in their 70s or 80s. Early onset Parkinson s disease (EOPD) begins before the~     age of 50. Researchers think EOPD may be caused by a mutation in a gene. They want to study~     the genetic causes so they can find therapies for this disease.~      Objective:~      - To better understand the genetic causes of EOPD.~      Eligibility:~        -  Adults ages 18 80 with a history of EOPD. Their family members, who do not have~          Parkinson s disease, can join as controls.~        -  Healthy volunteers ages 18 80.~      Design:~        -  Participants with EOPD and their relatives will be screened with a review of medical~          records. Healthy volunteers will have medical history, physical exam, and blood drawn.~        -  Relatives may send blood samples to NIH to test for mutations in genes that are linked~          to Parkinson s disease. They may have a physical exam.~        -  Participants may be asked to return to clinic for another visit that can last up to 2~          hours.~        -  During this visit, participants will have blood taken from a vein in the arm via a~          needle stick.~        -  Participants may give a sample of their skin. The skin on the arm or leg will be numbed~          and a small skin punch biopsy will be taken with a special needle.~        -  Some cells from the blood or skin sample may be grown in a lab to establish cell lines.~          The cells may also potentially be genetically modified to make stem cells.~        -  Researchers may perform genetic analysis on the samples to compare them to EOPD patient~          samples.~   "
41712|NCT02511002|"~     Background:~      - Influenza is a common viral infection. But it can be deadly for some people. Researchers~     want to learn more about how the body fights this virus. They want to study this in people~     who have recently been infected with influenza. They hope this can help them create more~     effective influenza vaccines.~      Objective:~      - To learn about long-term changes in the body s immune system after influenza infection.~      Eligibility:~      - People who have completed a previous LID Clinical Studies Unit influenza challenge study~     and are willing to have samples stored for future research.~      Design:~        -  Eligible participants will be asked to visit the clinic every 3 months for 2 years.~        -  During each visit, participants will have blood drawn from an arm vein using a needle~          and a syringe.~        -  Participants will have a medical history and physical exam and vital signs performed.~          This will include blood pressure, heart rate, breathing rate, temperature, weight, and~          finger-measured blood oxygen. They will answer questions about any medicines taken and~          possible recent illnesses.~        -  If participants have symptoms of influenza, they may have a sample taken from the nose.~          A small <TAB>amount of salt water will be sprayed into the nostril with a squeezable~          container. The salt water will then run out of the nose and into the container. Or the~          inside of the nose will be wiped with a swab that is~      similar to a Q-tip.~      - Participants will complete a health questionnaire once a month on a secure website.~     Participants may also give their responses over the telephone.~   "
41713|NCT02510989|"~     Syndromic obesity are rare forms of obesity (1% of cases), involving severe obesity and~     early to multi organ involvement (mental retardation, dysmorphic, sensorineural damage and /~     or endocrine). To date, the genetic defects are identified in only 5% of cases (Prader-Willi~     syndrome, Bardet-Biedl syndrome, mutation of leptin or its receptor, the proconvertase-1,~     proopiomelanocortin or SIM-1 and TRKB genes, high resolution karyotype or abnormal DNA~     chips, ...). Precocity and severity of obesity are those for a little dependent genetic~     environment.~      The investigators aim is to identify new gene variants in subjects with syndromic obesity~     sharing common phenotypic features.~   "
41714|NCT02510976|"~     Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis~     (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first~     regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second~     regimen in cross-over.~   "
41715|NCT02510963|"~     To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV)~     during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a~     randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with~     high HBV load and normal liver function will be treated with tenofovir during the middle or~     late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th~     gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th~     gestational week of mothers, the intrauterine HBV infection rate of infants will be compared~     across the three groups.~   "
41716|NCT02510950|"~     The early clinical development paradigm for chemotherapeutic agents has significantly~     influenced the development of therapeutic cancer vaccines. However, there are major~     differences between these two classes of therapeutics that have important implications for~     early clinical development. Specifically, the phase 1 concept of dose escalation to find a~     maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic~     cancer vaccines are associated with minimal toxicity at a range that is feasible to~     manufacture or administer, and there is little reason to believe that the maximum-tolerated~     dose is the most effective dose.~      In a recent article from the biostatistics literature, Simon et al. write that the initial~     clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather~     will involve administration of a fixed dose of vaccine … in most cases the dose selected~     will be based on preclinical findings or practical considerations. Using several dose levels~     in the initial study to find the minimal active dose or to characterize the dose-activity~     relationship is generally not realistic.~      Consistent with these recommendations, the general philosophy of the phase 1 clinical trial~     is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the~     personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test~     a fixed dose of vaccine. There is considerable experience with the synthetic long peptide~     vaccine platform. The synthetic long peptide vaccine platform has an excellent safety~     profile, and the optimal dose appears to be based on practical considerations (solubility of~     the peptide). The dose to be tested in the proposed clinical trial is consistent with other~     similar cancer vaccine trials that have been recently completed or are currently ongoing.~     The sample size (n=10) will provide a reasonably reliable estimate of the safety and~     immunogenicity of the vaccine.~   "
41717|NCT02510937|"~     Participation in the study will last for 3months, with a 1 month screening phase.~   "
41718|NCT02510924|"~     Airtraq sp has been proven effective for intubating patients presenting with difficult~     airway.~      The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.~      By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the~     visualisation of the tracheal inlet is possible for all the airway providers.~      The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves~     success rate of intubation (primary endpoint), as well as confort of the airway provider,~     shortens time for intubation and reduces injury to the patients.~   "
41999|NCT02507466|"~     The overall objective of this subproject is to evaluate the individual and paired~     contributions of intensity and variability of stepping training on lower extremity (LE)~     function, health and community participation in patients with chronic hemiparesis~     post-stroke.~   "
41719|NCT02510911|"~     Postoperative bowel paralysis is common after abdominal operations, including colectomy. As~     a result, hospitalization may be prolonged leading to increased cost. A recent randomized~     controlled trial from the University of Heidelberg showed that consumption of regular black~     coffee after colectomy is safe and associated with a significantly faster resumption of~     intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility~     is unknown but caffeine seems to be the most likely stimulating agent.~      Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis~     after elective laparoscopic colectomy?~      Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine,~     or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.~      The study is a randomized, controlled trial, with blinding of physicians, patients and~     nursing stuff (evaluating the endpoints).~      Primary endpoint will be the time to first bowel movement.~   "
41720|NCT02510898|"~     The purpose of this study is to determine whether a 6-week writing to heal~     seminar/workshop/class, Transform Your Life: Write to Heal, raises resilience scores as~     measured by the Connor-Davidson Resilience Scale for people who have recently experienced an~     emotional or physical trauma.~      Eligible subjects will be adults who self-identify as having had a recent emotional upheaval~     or physical health challenge. Potential subjects will be recruited through the use of~     flyers, advertisements, and emails to the Duke Integrative Medicine email list. Subjects~     will complete pen and paper measures at baseline and immediately post-treatment, including:~     the Connor-Davidson Resilience Scale, the 10-item Perceived Stress Scale, The 20-item Center~     for Epidemiological Studies Depression Scale, the 22-item Rumination Response Scale, and a~     baseline questionnaire.~      The investigators aim to target a sample of 30 completers by enrolling 37 participants. The~     risks of participation in this study are minimal, and include temporary sadness after the~     initial writing experience.~   "
41721|NCT02510885|"~     The objective of this study is to image retinal vascular alterations in patients with~     retinal disease using the AngioVue OCT-A system and understand the information these images~     provide. The investigators will image study participants who have retinal diseases with the~     AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of~     the information contained in images obtained on AngioVue. This study being conducted under~     an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks~     related to light exposure will be managed by ensuring that the exposure to the AngioVue~     light source is well below maximum permissible limits for safe exposure.~   "
41722|NCT02510872|"~     Early detection of viable residual tumor or early neoplastic recurrence represents a real~     challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell~     carcinoma of the upper aerodigestive tract.~      The locoregional recurrence rate is indeed high (up 40%) over the first two years of this~     therapeutic method.~      The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity~     because of the many post-treatment changes are fibrosis, tissue edema and the tissue~     distortion.~      PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and~     metastasis, even in the absence of clinical signs.~      To date, the acquired CT examination in the same time and in the same position that PET is~     performed without iodinated contrast injection, used for anatomical identification and~     attenuation correction of PET fused images. The patient usually has a second CT imaging,~     centered on the neck with contrast injection iodized within the radiology department.~      To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan~     with contrast injection iodized in the diagnosis of early recurrence in head and neck~     malignancies while interest of the contrast agent injection has been demonstrated in ovarian~     neoplastic recurrence research, pancreatic and colon.~   "
41723|NCT02510859|"~     Malnutrition is currently a major factor of morbidity and mortality, which poses a major~     public health problem in developing countries but also, albeit to a lesser degree and for~     different reasons, for industrialized countries. It is recognized that in countries of the~     North, from 30 to 60% of hospitalized patients suffer from dénutrition.~      In any case, it is covered by an imbalance between the contributions and needs; the two main~     mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased~     requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways~     (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate.~     Patients included in this study are a population at risk, because of their therapeutic~     containing at least radiotherapy. It is recognized that this form of therapy exposes dental~     complications, mucous, saliva. These complications have a deleterious effect on the~     nutritional status of patients.~      The diagnosis, treatment and prevention of dénutritions have an important place in the~     therapeutic strategies of this type of cancer because it is events whose incidence and~     morbid consequences are high and for which there are appropriate nutritional treatments in~     most cas. While the complete correction of malnutrition generally passes by the effective~     etiological treatment of the causal pathology, therapeutic efficacy of the latter is often~     conditioned by the nutritionnel state.~      In addition to these concepts, investigators wants to study the benefits of a diet followed~     during the irradiation phase of patients with head and neck cancers and New treaties. We~     propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary~     consultation at home on the life quality of patients with head and neck cancer including~     first therapeutic sequence involves radiotherapy more or less aware. The duration of the~     study is 24 months.~      The main objective is to evaluate the impact of a dietary consultation at home on the life~     quality of patients with head and neck cancer including first therapeutic sequence involves~     a more or less sensitized radiotherapy.~   "
41724|NCT02510846|"~     Profound multiple disabilities also called in French polyhandicap are defined by the~     combination of a deep mental disability and severe motor deficit with extreme restriction of~     autonomy. Life in institution for people with profound multiple disabilities induces~     emotional and educative deficiency and often conducts to behavioral disorders. These~     behavioral disorders also impact on quality of life and feelings of caregivers. An intensive~     multimodal educative program proposed to patients with profound multiple disabilities can~     improve their psychic well-being, reduce chronic pain and improve also quality of life and~     feelings of caregivers. The intensive multimodal educative program will be compared to the~     usual practice of educative program.~   "
41765|NCT02510313|"~     The proposed study will test the effectiveness of the Strong Families, Thriving Children~     Sugira Muryango program as delivered by community based workers and aligned with the~     Rwandan social protection system. Sugira Muryango is a preventive, family-based model that~     uses home visiting and coaching to encourage responsive parent-child interactions and~     discourage violence and harsh punishment targeting families living in extreme poverty.~     Integration of scalable, cost-effective interventions into poverty-reduction and other~     social welfare programs has great potential as an effective means to promote child~     development and reduce familial violence and in a range of culturally diverse, low-resource~     settings.~   "
41725|NCT02510833|"~     Parkinson's disease (PD), neurodegenerative and common from 50 to 60 years, is characterized~     by rigidity, bradykinesia and resting tremor that can interfere in the quality of life. To~     maintain or improve this, there is the physiotherapy. Problems in access, such as walking~     and financial difficulties, make home exercises target of interest. The study aims to assess~     the impact of a program of home therapeutic exercises, with individualized approach and~     remote monitoring by physical therapist, about signs and symptoms of Parkinson's disease and~     quality of life. This is a randomized controlled clinical trial, conducted at the Program~     Pró-Parkinson of the Clinics Hospital, Federal University of Pernambuco, Neurology Clinic.~     Will be included people of both sexes (50 years) with idiopathic PD, stages 1-3 in Hoehn &~     Yahr original; non-institutionalized and independent walking. It will be applied before and~     after 12 weeks of intervention (period ON of medication): Survey about Knowledge, Attitudes~     and Practice; Questionnaire of Accession; Unified Scale Evaluation of Parkinson's disease~     (UPDRS) - subscales II and III; and Parkinson's Disease Questionnaire 39 (PDQ-39).~     Participants will be randomized into two groups: Group continued intervention (GIC) and~     control group (CG). The GIC will have an meeting with individualized approach (physical~     therapist, patient and companion) for guidance on home physical therapy exercises, using the~     Manual Pró-Parkinson, then the participant will receive the manual with stretching~     exercises, mobility, balance and strength, which will lead to your home as a way to guide~     their activities; and receive weekly follow-up by phone calls (to remember the exercises,~     answer questions and encourage the continued practice). GC may be attend presentations on~     home exercises of the Pro-Parkinson's manual in the days of your query and have the same~     manual without remote follow-up by phone calls, usual service procedure. Exercises are~     oriented to be performed three times a week for 12 weeks and under the effect of~     anti-Parkinson medication. This study will contribute new evidence on the effects of a~     rehabilitation program available and inexpensive based on home exercises.~   "
41726|NCT02510820|"~     This will be a controlled and randomized, single-masked, crossover study in which 48~     subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care~     products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each.~     Follow-up visits for each solution will take place at one week, two weeks and four weeks:~     with a one-week 'wash-out' period between the solutions. Key outcome measures for this study~     include biomicroscopic and subjective responses to the lens/solution combinations.~   "
41727|NCT02510807|"~     The literature has shown that supervised exercise programs for patients with PAD and who~     report intermittent claudication (IC) have improved health outcomes, but this is not locally~     available. Introducing the use of a pedometer may act as a method to encourage patients to~     continue on their independent exercise regimen. There is very little literature which has~     examined the effectiveness using pedometers as a measure of compliance within this~     population.~   "
41728|NCT02510794|"~     This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of~     three different formulations of ranibizumab delivered via the Ranibizumab Port Delivery~     System (RPDS) implant compared with the standard of care (SOC) intravitreal (ITV) injections~     of ranibizumab, in participants with subfoveal neovascular age-related macular degeneration~     (AMD).~   "
41729|NCT02510781|"~     Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with~     human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a~     higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity~     when used the anthracycline instead of carboplatin. The investigators expect to carry out a~     large sample size clinical research to optimize the existing therapeutic regimen~   "
41730|NCT02510768|"~     The study is designed to evaluate the efficacy of two formulations of a cross-linked~     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred~     to as ELAPR or ELAPR002) for the treatment of Striae Distensae (SD) alba when administered~     as intradermal implants.~   "
41731|NCT02510755|"~     A broad group of disorders is associated with severe stress existence in children or~     adolescents. The most characteristic result, and one of the most serious being the state of~     post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual~     violence, and to a lesser extent, accidents public road or natural disaster, whose child was~     the subject or witness. PTSD is associated with a deleterious effect on cognition and~     including the mnemonic operation. The painful reminder of the traumatic event is one of the~     most disabling symptoms. However, there are many other memory disorders that experimental~     studies gradually update. They maintain a close link with emotional regulation that~     disturbed you know if PTSD. However the majority of studies on emotion and cognition and~     their relationship with brain activity took adult subject. Work in adolescents are few on~     the morphological study, on rare neurobehavioral and reduced to two studies of functional~     neuroimaging. Contrary to what is observed in adults, morphological studies report~     consistently, no reduction in hippocampal volume. There is no study in the idle state. Two~     studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity~     of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second~     reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The~     objective task of our study is to evaluate the impact of psychological trauma on brain~     structures involved in the emotional component of the memory (amygdala, hippocampus,~     prefrontal cortex in particular). For this, the investigators will take in 33 adolescents,~     including patients with posttraumatic symptomatology and matched controls free of trauma~     age, several neuroimaging exams, anatomical and functional. The functional review will~     include some rest and another in activation during episodic memory task designed to assess~     the influence of self-perception on memory impairment observed in patients. The~     investigators will check, for each group of patients and controls, the involvement of~     cortical structures in relation to the regulation of emotional memory (CCA, amygdala and~     hippocampus). The anatomy of the hippocampus benefit specific imaging methods developed in~     the unit INSERM U923. Endocrine correlates of stress tests will be studied by a~     fully-traumatic by salivary cortisol sampling.~      This research will clarify the mechanisms involved in emotional and memory impairments~     secondary to psychological trauma, their relationship with self (judgment and self-esteem)~     and studying their morphological substrates. A longer-term goal is to offer help in the~     diagnosis and monitoring of young patients with posttraumatic symptomatology.~   "
41732|NCT02510742|"~     Hypothesis:~      Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological~     parasympathetic upregulation which increases VMCA, concentration and cephalic vessel~     diameter.~   "
41733|NCT02510729|"~     Hypothesis:~      Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological~     parasympathetic upregulation which increases mean velocity in middle cerebral artery (VMCA)~     and diameter of the superficial temporal artery.~   "
41734|NCT02510716|"~     The purpose of this study is to evaluate the feasibility, acceptability and preliminary~     efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service)~     text messaging plus SMS Support Messages in decreasing smoking in an older adult rural~     population. The SGR group (n=20) will receive a four-week SGR program delivered via SMS text~     messages plus SMS support messages. The control group (n=20) will receive SMS support~     messages to aid in quitting.~   "
41767|NCT02510287|"~     The analgesic approach in labor can be done in different ways, among which the neuraxial~     approach has shown the best analgesic results and fetal outcomes. Currently, programmed~     epidural intermittent bolus has been included in the neuraxial approach for a better~     distribution of the solution into the epidural space as compared with the continuous~     infusion strategy. In this study, the investigators seek to compare both strategies in 132~     laboring women.~   "
41768|NCT02510274|"~     The objective of this study is to assess PK, safety and tolerability of a single oral dose~     of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered~     t.i.d. before or just after each meal~   "
41735|NCT02510703|"~     Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function,~     especially in the coronary arteries, which are a factor of poor prognosis. Following acute~     coronary syndrome, the endothelial function abnormalities usually persist for several weeks~     before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor~     prognostic factor. Investigators assume that global abnormalities of endothelial function in~     patients with diabetes may be additive with segmental abnormalities in revascularized~     myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there~     is no published data showing any relationship between calcium score and endothelial function~     abnormalities in these patients. The investigators seek a relationship between calcium score~     and persistence of abnormalities of coronary endothelial function in these patients.~      The main objective of this study was to compare coronary endothelial function by~     quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute~     coronary syndrome.~   "
41736|NCT02510690|"~     This study aims to analyse the results of national data collected by the e-Dengue~     Information System in order to determine the factors associated with disease outcomes in all~     patients registered from January 2013 to December 2014.~   "
41737|NCT02510677|"~     The prognosis of patients with heart failure has improved due to recent breakthrough in~     medical treatment and cardiac resynchronization devices. However, there is no paraclinical~     parameter to assess response to cardiac resynchronization therapy (CRT). This is a major~     issue since about a third of implanted patients will not be improved by CRT. CZT SPECT~     allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study~     myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.~      Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular~     dyssynchrony in viable segments in patients with heart failure eligible for CRT.~   "
41738|NCT02510664|"~     The purpose of this study is to determine whether a newly developed intervention is feasible~     and acceptable to adolescents with type 1 diabetes and their families and diabetes care~     providers, and to evaluate trends in whether the intervention impacts important diabetes~     outcomes. The intervention involves diabetes care providers discussing and reinforcing~     individuals' and families' diabetes management strengths during routine, outpatient diabetes~     care appointments.~   "
41739|NCT02510651|"~     ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant~     repigmentation did not show significant difference with better healing of the donor site.~     Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better~     results using combination of donor NCECS and recipient cryoblebs.~   "
41740|NCT02510638|"~     Dengue infection has been identified as the fastest spreading mosquito-borne viral disease~     by World Health Organization (WHO), which affects more than 2.5 billion people living in the~     subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus~     serotypes circulating and responsible for the escalating number of cases over the years. As~     of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in~     Malaysia; and the total number of dengue cases reported in the same period was 23,966 which~     is 46% higher than the same reporting period of 2014. Although dengue virus has been~     identified for so many years and plenty of research work has been carried out, it was proven~     that there are still many aspects that we are not too sure about the disease. Therefore,~     this multi-center, observational cohort study is designed to investigate the clinical course~     of hospitalized dengue infection in Malaysia. The study population of this study consists of~     male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This~     study will be conducted in 2 stages whereby the 1st stage will only focus on the basic~     social and clinical data to describe the clinical course of dengue as general and the 2nd~     stage will collect the more detailed clinical and management data to describe the detailed~     clinical course, management and prognosis of dengue. All hospital participation in this~     study is voluntary, and approval will be obtained from National Institute of Health (NIH)~     and Medical Research Ethics Committee (MREC) prior to any recruitment.~   "
41741|NCT02510625|"~     The objective of this study is to investigate arthroscopic treatments of recurrent anterior~     shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction~     with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The~     investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft~     will provide better functional outcomes and decreased risk of recurrent~     dislocation/subluxation.~      This will be a single center, double blinded, randomized controlled trial performed in~     Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario~     Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation,~     and range of motion. A minimum of 200 patients will be enrolled in the study as determined~     by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D~     reconstruction and MRI are obtained for all patients. The patients will then undergo a~     clinical examination and complete a variety of functional and quality of life surveys.~     Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic~     glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients~     in both groups will follow a standardized rehabilitation protocol. The patient will~     follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the~     3, 6, 12, and 24 month visits the patient will again undergo the structured clinical~     examination conducted by a physiotherapist who is blinded to the patients' treatment group.~     The patient will also complete the questionnaires at each of these follow-up appointments.~     Complications, and subluxation/dislocation events will be documented at each follow-up~     evaluation. On the basis of a clinical examination and patient history, the surgeon will~     diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or~     dislocation.~   "
41742|NCT02510612|"~     Dexmedetomidine's Sedative Effect on Diabetic Patient~   "
41743|NCT02510599|"~     The purpose of this study is to evaluate the effects of solithromycin on hepatic histology~     and biomarkers in patients with nonalcoholic steatohepatitis.~   "
41744|NCT02510586|"~     The aim of the present study is to evaluate the effect of sevoflurane postconditioning on~     the incidence of postoperative hyperperfusion syndrome following revascularization surgery~     in moyamoya patients.~   "
41745|NCT02510573|"~     The current study was designed to investigate the change of serum ficolin-3 levels and~     assess the prognostic predictive effect of serum ficolin-3 levels in the patients with~     severe traumatic brain injury.~   "
41746|NCT02510560|"~     The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm~     infants.~   "
41769|NCT02510261|"~     The purpose of this study is to evaluate the safety and efficacy of long-term dosing with~     ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).~   "
42027|NCT02507102|"~     This feasibility study will assess the effects of the Nativis Voyager therapy in patients~     with recurrent GBM who have either failed standard of care or are intolerant to therapy. The~     study will enroll and treat up to eleven subjects over six months. Safety and clinical~     utility will be evaluated.~   "
41747|NCT02510547|"~     CrossBoss First is a single-blind randomized controlled trial that will randomize 246~     patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary~     Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation~     strategy The CrossBoss First study has two primary objectives. The primary efficacy~     objective is to compare the procedure time required to cross the CTO or abort the procedure~     with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize~     that upfront use of the CrossBoss catheter will be associated with shorter procedure time~     required for CTO crossing compared with an antegrade wire escalation strategy.~      The primary safety objective is to compare the frequency of procedural major adverse~     cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation~     strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be~     associated with similar incidence of MACE compared with an antegrade wire escalation~     strategy.~      The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure~     time (defined as the interval between administration of local anesthesia for obtaining~     vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and~     total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume;~     and (6) number of wires, microcatheters, balloons, and stents used.~   "
41748|NCT02510534|"~     To determine the difference in clinical pregnancy rates with and without luteal progesterone~     support in a young reproductive aged population having undergone ovulation induction with~     combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.~   "
41749|NCT02510521|"~     Type 2 diabetes is a major public health problem because of its increasing prevalence and~     morbidity and mortality that accompanies it. Therapeutic management of this pathology,~     lifestyle measures, dietary and physical activity are fundamental. Their observance is~     unfortunately too often insufficient, leading to a therapeutic climbing with first oral~     antidiabetic (OAD) then the use of insulin therapy.~      Yet there is now ample evidence that physical activity improves glucose control in these~     patients in particular improving insulin sensitivity after a training period but also after~     a single session of physical activity.~      Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical~     therapy, patients with neurological or after orthopedic surgery in particular. In fact, this~     method enables improvement of volume and strength, even for denervated muscles. Recent~     studies have also shown the benefits of NMES in situations of cardiac or respiratory~     readjustments. In addition, NMES is used by top athletes supplements classical training in~     order to develop muscle strength or speed recovery.~      Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity~     in type 2 diabetic patients treated with OAD (excluding glitazone). To do this,~     investigators plan to assess their insulin sensitivity by the reference method of~     hyperinsulinemic euglycemic clamp before surgery, after a single session of bilateral~     quadriceps NMES and after a sequence of daily training 6 days a quadriceps NMES bilateral.~      Investigators hope to show an improvement in insulin sensitivity by this method, which would~     constitute an alternative to physical activity in the treatment of diabetes type 2. This~     procedure would be particularly interesting in diabetic subjects with type 2 counter-~     indications or an inability to perform a conventional physical activity.~   "
41750|NCT02510508|"~     The aim of this study is to determine whether a group format Community Reinforcement and~     Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than~     non-intervention in terms of Concerned Significant Others (CSO) well- being and cost-~     effectiveness.~   "
41751|NCT02510495|"~     The purpose of this study is to determine how different endoscopic papillary balloon~     dilatation (EPBD) duration time affects the complications after endoscopic retrograde~     cholangiopancreatography (ERCP) in the treatment of common bile duct stones.~   "
41752|NCT02510482|"~     Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the~     cornerstone in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as~     cardiac troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition~     of complications concerning the aortic valve and decompensation. For this purpose, it is~     important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The~     assessment of biological variation will contribute to a better understanding of fluctuation~     of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of~     CAVS using cardiac biomarkers.~   "
41753|NCT02510469|"~     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance~     therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive~     exfoliative cancer cells.~   "
41754|NCT02510456|"~     This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to~     evaluate the efficacy of an investigational imaging technology known as Diffuse Optical~     Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI~     is a noninvasive imaging method that uses harmless near-infrared light using a simple~     handheld probe held against the skin to predict tumor metabolic activity. It uses~     nonionizing radiation, requires no external contrast agent and uses low light exposure to~     human tissue. DOSI scans can be performed frequently at the bedside in settings such as a~     doctor's office or infusion center.~   "
41755|NCT02510443|"~     Using a very broad survey, the objective is to confirm the effectiveness of the Essure~     method, and to obtain more information on the conditions of use as well as on the methods~     used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on~     patients.~   "
41756|NCT02510430|"~     Excessive sitting time (sedentary time) has been associated with risk of insulin resistance~     and other factors which may be relevant to breast cancer prognosis. This 8-week study tests~     different strategies for helping breast cancer survivors to modify their levels of sitting~     time. Participants will be assigned with equal likelihood to one of three groups (1) overall~     reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3)~     usual care.~   "
41766|NCT02510300|"~     This Registry will enroll adolescent and pediatric participants who received at least one~     Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a~     Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry~     is to determine the long-term safety of anti-HCV regimens in the pediatric population.~     Secondary objectives of this Registry are to determine whether subsequent detection of HCV~     RNA in participants who relapse following sustained virologic response (SVR) represents the~     re-emergence of pre-existing virus, the development of resistance mutations, or whether it~     is due to re-infection, and to characterize resistance mutations and the persistence of~     resistance mutations in pediatric participants who did not achieve SVR. Once enrolled,~     participants will be followed for up to 5 years.~   "
42028|NCT02507089|"~     This study aims to develop educational tools and platforms to promote the transfer of sleep~     health information to blacks to foster adoption of healthful sleep practices.~   "
41757|NCT02510417|"~     The primary purpose of the study is to evaluate whether most closely HLA-matched~     multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell~     lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus.~      Reconstitution of anti-viral immunity by donor-derived VSTs has shown promise in preventing~     and treating infections associated with CMV, EBV and adenovirus post-transplant. However,~     the time taken to prepare patient-specific products and lack of virus-specific memory T~     cells in cord blood and seronegative donors, limits their value.~      An alternative is to use banked partially HLA-matched allogeneic VSTs. A prior phase II~     study at our institution using trivirus-specific VSTs generated using monocytes and~     EBV-transformed B cells gene-modified with a clinical grade adenoviral vector expressing~     CMV-pp65 to activate and expand specific T cells showed the feasibility, safety and activity~     of this approach for the treatment of refractory CMV, EBV and Adenovirus infections.~     However, the production process was lengthy, requiring 8-12 weeks, with exposure to~     biohazards (B95.8 EBV viral strain and adenovector), while antigenic competition between~     different viral components precluded increasing the spectrum of specificity beyond these~     three viruses.~      Investigator have overcome these limitations and in the current trial, they will evaluate~     whether rapidly generated, allogeneic most closely HLA-matched multivirus-specific VSTs,~     activated using overlapping peptide libraries spanning immunogenic antigens from CMV,~     adenovirus and EBV will be safe and produce anti-viral effects in allogeneic HSCT recipients~     infected with one of more of the targeted viruses that are persistent despite conventional~     anti-viral therapy. The study agent will be assessed for safety (stopping rules defined) and~     antiviral activity.~   "
41758|NCT02510404|"~     PIDD represent an expanding group of genetic disorders that compromise immunity against~     bacteria, viruses, and fungi. The most severe forms of PIDD cause profound susceptibility to~     opportunistic infections due to impaired or absent T-cell immunity. These diseases can be~     rapidly fatal unless treated via hematopoietic stem cell transplantation (HSCT). Chronic~     viral illnesses are a common presenting feature of many of these disorders, and studies have~     shown that survival of HSCT is profoundly impacted by the patient's pre-transplant disease~     status. Primary infections with viruses such as cytomegalovirus (CMV) and Epstein-Barr virus~     (EBV) are common, and respiratory viruses such as adenovirus also frequently cause~     infection. In patients with severe combined immunodeficiency (SCID), a prior study~     identified these viruses as the most common causes of mortality in the immediate period~     following HSCT. Though some forms of PIDD are amenable to HSCT without requiring~     conditioning chemotherapy, many forms require a variable degree of pre-conditioning to~     ensure that stable engraftment of the donor cells is achieved. The administration of~     cytotoxic chemotherapy used in the conditioning regimens can however increase the risk for~     regimen related toxicity and for some patients (especially those with active viral~     infections) this risk is particularly high, leading to high treatment related mortality~     rates. For these reasons, many such patients are not even considered candidates for HSCT or~     are delayed getting to HSCT and ultimately succumb to infection before they can receive the~     transplant.~      The primary objective of this study is to determine the safety of administering third-party~     multivirus-specific cytotoxic T lymphocytes (mCTL) from adult CMV seropositive donors to~     treat refractory viral infections in patients with primary immunodeficiency disorders (PIDD)~     prior to hematopoietic stem cell transplantation (HSCT).~   "
41759|NCT02510391|"~     This nonrandomized pilot study is investigating the efficacy of a modularized treatment for~     anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment,~     followed by a second baseline assessment one month later. The treatment protocol,~     Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows~     for individualized treatments based on a treatment algorithm, ensuring that sessions address~     the most pressing clinical needs of each child. Treatment consists of weekly 60-minute~     sessions delivered over the course of 12 weeks. Symptom change is tracked weekly during~     brief phone assessments and a post-treatment assessment will occur following the final~     treatment session, approximately 12 weeks after starting treatment. Finally, all~     participants will complete two follow-up assessments, occurring 1-month and 6-months after~     the final treatment session.~   "
41760|NCT02510378|"~     Patients with rectal cancer and resectable liver metastases receive short course~     radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4~     cycles after 2 weeks.~   "
41761|NCT02510365|"~     The study is designed to assess the safety and efficacy of functional neural regeneration~     collagen scaffold transplanted into acute spinal cord injury patients.~   "
41762|NCT02510352|"~     In accordance with national guidelines surgical repair of rotator cuff tear is the~     first-line strategy only in young patients, depending on tear size, fatty infiltration of~     rotator cuff muscles and articular status. In appropriate situations, a satisfactory result~     is expected in more than 80% of cases with a very good long-term outcome. On the other hand,~     the first-line strategy in older patients is conservative as the main objective is the~     treatment of pain and stiffness of the shoulder which can be achieved at least in the~     short-term with general and local medications and physiotherapy. In addition, poor~     prognostic factors such as massive tears and muscle fatty infiltration or atrophy, are more~     frequently present in those patients, leading to poor results of surgical treatment and a~     high risk of iterative tear after repair.~      Because of a lack of evaluation, there is currently no identified prognostic factor of~     medical treatment and on the other hand no clinical situation in which a surgical repair is~     mandatory. Therefore, investigator designed this study as an observatory with the follow up~     of patients with a symptomatic rotator cuff tear treated conservatively.~   "
41763|NCT02510339|"~     The goal of this project is to determine the incidence of intra-articular knee pathology~     following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical~     exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial~     nail via MRI.~   "
41764|NCT02510326|"~     The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is~     important in transfer of load from the thumb and radial hand to the scaphoid and the~     radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common~     degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true~     incidence of arthritis in the STT joint however is unknown though we assume that most cases~     of arthritis are not clinically significant. Furthermore, the clinical and biomechanical~     significance of arthritis in this joint is unclear. The investigators' clinical impression~     is that the incidence of STT joint arthritis is inversely related to that of radiocarpal~     joint arthritis. In an ongoing study, we are examining the relationship between STT joint~     arthritis and radiocarpal joint arthritis on radiographs.~      We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting~     movement of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal~     arthritis by limiting instability of the scaphoid.~      The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid~     within the STT joint using a computer-generated model based on CT scan of the wrist and to~     compare this model with the already established model of the normal STT joint.~      The investigators' hypothesis is that there is significantly less motion in the arthritic~     STT joint.~   "
42061|NCT02506647|"~     This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over,~     pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan &~     Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with~     type 1 diabetes mellitus (T1DM).~   "
41770|NCT02510248|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part~     study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704~     will be assessed in healthy adult subjects and in adult subjects with CHC infection.~      Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of~     AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be~     randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2~     assigned to placebo), in a fasted state.~      The planned dose-escalation scheme may be changed based on the emerging PK and safety data.~     Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses~     at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic~     (PK) profile, and the presence of an acceptable safety profile.~      Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part~     1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the~     same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of~     7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose)~     will be selected, however this depends on the evaluation of available PK and safety data~     from Part 1 of the study.~      Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be~     evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC~     genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7~     consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed~     state. The treatment is anticipated to be administered in a once daily dose regimen or a~     twice daily dose regimen. The dose and dose regimen to be administered will be determined by~     the Sponsor depending on the PK and safety outcomes of previous cohorts.~   "
41771|NCT02510235|"~     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms~     of discomfort, visual disturbance, and tear film instability with potential damage to the~     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation~     of the ocular surface.~      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted~     product of cells that line the joint tissues, which is present at the surface of articular~     cartilage and it has been investigated on its roles at the ocular surface, in normal and~     pathologic conditions such as dry eye.~      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin~     eye drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops~     solution in subjects with moderate dry eye.~   "
41772|NCT02510222|"~     This study is considered a pilot exploratory study. Intervention, prospective, double-armed,~     randomized, placebo-control clinical trial.~      The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be~     studied.~   "
41773|NCT02510209|"~     This study tested the extent to which TOP®, when replicated with fidelity, produced impacts~     on sexual risk-taking behaviors in the short term and the longer term.~   "
41774|NCT02510196|"~     Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day -~     Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding~     of written English used in the questionnaires~      Stage 1 - training The aims and requirements of the teaching program will be explained to~     the participants at the start of the workshop. All participants will be given a sticker with~     a number and a questionnaire numbered about current ultrasound practice which is numbered~     according to participant number to allow for blinding. Anyone not wishing to participate can~     either remove their sticker or not return the questionnaire at the end of the session. The~     number on the questionnaire correlated to participant number. This will be recorded against~     the participant name to allow for further follow up. All participants will rotate normally~     throughout the sessions. At the end of the neuraxial session participants will be scored by~     the session leader according to their ability to adequately carry out the procedure. Scores~     will be correlated to participant number.~      Stage 2 - assessment of skill retention~      Following the training day participants will randomly be allocated into two groups. One~     group will receive regular reminders to use ultrasound for all neuraxial anesthesias they~     perform in the OR or labor ward. They will be reminded on a regular basis that ultrasound is~     a new tool to assist them in performing neuraxial ultrasound. The other group with be~     allowed to continue with their regular practice and will not receive reminders to use~     ultrasound for neuraxial anesthesia insertion. Two months after the initial training day all~     participants with be observed performing neuraxial anesthesia and re-assesed according to~     the original scoring system. Each participant will be assessed 3 times over a 6 month~     period.~   "
41775|NCT02510183|"~     This study is to evaluate the effect of preoperative acupressure application on~     Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy~     in terms of being in high risk group for PONV.~   "
41776|NCT02510170|"~     In this study, measurements of fetal and maternal head circumference will be collected. This~     data will be presented in table or graph form. The effect of maternal head circumference on~     fetal head circumference will be evaluated and presented in either formula or graph form.~   "
41777|NCT02510157|"~     This study aims to investigate the possible clinical effect of dexamethasone on the action~     of sugammadex when it is administered to reverse deep neuromuscular blockade caused by~     rocuronium in laparoscopic cholecystectomies.~   "
41778|NCT02510144|"~     Propionibacterium acnes is the most common pathogen identified from a surgical site~     infection in the shoulder. Standard skin preps do not prevent this type of infection.~     Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to~     surgery. Bacterial burden will be determined at the time of surgery.~   "
41779|NCT02510131|"~     To determine whether Hyacinth exercises are more effective than Kegel's exercise at~     improving pelvic floor weakness among women aged 55 and above with urinary incontinence.~   "
41780|NCT02510118|"~     The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli~     based on chemotherapy for colon cancer patients by a randomized, parallel-group,~     double-blind, multicenter clinical study.~   "
41781|NCT02510105|"~     The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive~     Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography~     (CT).~   "
41782|NCT02510092|"~     This study evaluates in vivo intracoronary imaging using intravascular ultrasound and~     optical coherence tomography and safety and efficacy of new generation fully bioresorbable~     vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed~     connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant~     coronary disease patients.~   "
41783|NCT02510079|"~     The primary purpose of this research study is to determine the safety of injecting ones own~     Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the~     sciatic nerve has occurred.~   "
41784|NCT02510066|"~     This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic~     cancer pain and then investigates its potential mechanism of peripheral blood.~   "
41785|NCT02510053|"~     To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients~     after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40~     patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in~     this study. Caspofungin plasma concentrations are measured by using solid phase extraction~     and reverse phase high-performance liquid chromatography. Safety analyses will be taken~     daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy~     assessment (clinical and mycological responses) will be taken every 3 days by clinical and~     mycological tests.~   "
41786|NCT02510040|"~     The purpose of this study is to describe clinical characteristics, treatments, and one-year~     outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle~     hypertropia.~   "
41787|NCT02510027|"~     While there is broad consensus that HR-HPV detection is the best available primary screening~     test, there is no agreement about the most efficient and reliable triage procedure for~     HR-HPV positive women. Transient HR-HPV infections are very common, and the vast majority of~     these infections spontaneously regress after a year or two. Only a small fraction of cases~     will lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a~     large, population-based study that was designed to evaluate the performance and~     cost-effectiveness of different triage strategies for hrHPV-positive women in Mexico.~   "
41788|NCT02510014|"~     A multi-center, open-label, long-term safety study in which approximately 600 subjects~     diagnosed with opioid use disorder will be enrolled. Following a screening period, all~     subjects will receive run in SUBOXONE sublingual film followed by monthly injections of~     open-label high dose RBP-6000. RBP-6000 dose can be adjusted to low dose, and back to high~     dose, based on the medical judgment of the Investigator. Subjects will participate in the~     study for either 6 or 12 months.~   "
41789|NCT02510001|"~     This trial is designed to try two new cancer drugs together for the first time. The~     investigators think that they might be effective in some types of bowel cancer. The first~     part of the trial will see what doses of the two drugs can safely be given together. Once~     the investigators have identified a suitable dose combination they will look at how~     effective treatment is in bowel cancers where either the RAS gene is mutated, or MET is~     over-active. In the trial the investigators will look at samples of blood, skin and tumour~     to check the drugs are working in the way expected. The trial will take place in three sites~     in the UK and 5 sites in Europe. The trial is funded as part of the European commission's~     FP7 program.~   "
41790|NCT02509988|"~     The study aims to assess whether a nutritional drink taken before conception and continuing~     through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother~     and promotes offspring health.~   "
41791|NCT02509975|"~     This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and~     effectiveness study of OCL 503 in men with BPH.~   "
41792|NCT02509962|"~     To study the effects of an increased salt intake on metabolic, cardiovascular and~     immunoregulatory functions in healthy men.~   "
41793|NCT02509949|"~     Delirium, an acute change in mental status, is a serious medical complication among~     hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective~     disorders and cognitive disruptions.~      One vulnerable period for developing delirium is in the postoperative days. Postoperative~     delirium often initiates a cascade of adverse consequences including an increase in length~     of stay and hospital costs, and greater mortality. The investigators have observed that the~     incidence of postoperative delirium in patients after renal transplantation is about 20-30%~     in our hospital.~      Several studies have revealed that dexmedetomidine, as a widely used sedative during~     anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The~     investigators aim to examine whether administration of dexmedetomidine can reduce~     postoperative delirium after living donor renal transplantation in adult patients.~   "
41794|NCT02509936|"~     This study seeks to evaluate the impact of an intensive home-based education intervention~     targeting severely stunted Guatemalan children for catch up growth and improved development.~     Half of the children in the study will receive standard of care, which includes~     micronutrient supplementation and a food ration. The other half of children in the study~     will receive, in addition to the above, home-based dietary assessment and individualized~     parental nutrition education.~   "
41795|NCT02509923|"~     The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10~     mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male~     Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.~   "
41796|NCT02509910|"~     This study examines the effect of an algorithm for GDT for patients undergoing major surgery~     under routine conditions.~   "
41797|NCT02509897|"~     To study the effects of hypoxia at rest and during moderate physical activity on~     cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure,~     immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple~     sclerosis patients.~   "
41798|NCT02509884|"~     Comprehensive diagnosis and treatment of Alveolar Echinococcosis : A single-center,~     long-term observational study of 312 Patients in Germany. Human alveolar echinococcosis (AE)~     is the most Iethal human helminthic infection and is one of the 17 neglected tropical~     diseases prioritized by the World Health Organization (WHO). Its incidence is low in endemic~     regions of Central and Western Europe (0.03-0.05/100,000), but morbidity and treatment costs~     are high. In this observational study, the investigators assessed the severity of the~     disease using the PNM staging system and report on the long-term results of specific AE~     therapy in an interdisciplinary team of clinicians.~   "
41799|NCT02509871|"~     This cross-sectional study of pathophysiology will bring additional informations on body~     composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a~     complementary study of Metaca study (AU882).~   "
41800|NCT02509858|"~     We investigated the effect of the administration of small doses of thyroxine to healthy~     humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake,~     insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment~     in the plasma membrane of monocytes.~   "
41801|NCT02509845|"~     The purpose of the clinical study is to evaluate the safety and bacterial impact of study~     drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental~     subjects.~   "
41802|NCT02509832|"~     COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess~     Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute~     Myocardial Infarction.~      Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL~     Proteus IVTM System into existing STEMI treatment protocols for subjects who present with~     acute anterior myocardial infarction.~   "
41933|NCT02508116|"~     This is a randomized, prospective, open label study to determine the cost-effectiveness of~     genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI)~     with stent implantation, will be randomized either to genotype guided dosing of antiplatelet~     therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine~     CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.~   "
41803|NCT02509819|"~     The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed~     to reduce pain and improve function for individuals with foot/ankle pain and/or weakness.~     Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be~     designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge,~     while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe~     system. The goal of this research is to determine how heel wedge properties may contribute~     to the smoothness of roll-over during gait. Insight into the effects of heel wedge~     properties on roll-over will help optimize the design of the IDEO-heel wedge-shoe system~     and may produce guidelines for the customization of these features.~   "
41804|NCT02509806|"~     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance~     therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive~     Gastric Cancer.~   "
41805|NCT02509793|"~     The purpose of this research study is to see if tetrabenazine, which is commonly used to~     treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in~     patients with HD. Investigators will also see how the medicine affects aspects of thinking~     and mood.~   "
41806|NCT02509780|"~     Vichy water is a type of spring water which traditionally comes from the famous spa town of~     Vichy, France. The springs which feed Vichy carry a high amount of dissolved minerals.~     Alkaline salts such as sodium bicarbonate are a primary ingredient in Vichy water, along~     with calcium and magnesium carbonates.~      Bicarbonates alkalinize urine, which is fundamental in preventing and/or diluting uric acid~     crystals. These are the main component of the uric acid stones or even oxalate stones, which~     generally  use  a crystal of uric acid as nucleus for stone formation. Cystine stones can~     also be treated by alkalinizing urine.~      Any disorder leading to a low urinary pH ( < 5.5 ) may predispose to stone formation. In~     this context , the solution of uric acid and the prevention and treatment of uric acid~     stones can be obtained by alkalization of the urine . The ideal alkalization is achieved~     when a urinary pH of 6-6.5 can be reached.~      The aim of this study is to evaluate the quantity of daily intake of the Vichy water~     necessary to obtain this alkalization of the urine. There are no data available in the~     literature about the relationship between the absolute quantity of Vichy water taken and the~     urinary pH ; nor about the possible influence of the Body Mass Index on this relationship.~   "
41807|NCT02509767|"~     This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate~     (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient~     populations. Prior studies demonstrate that DMPA self-injection is safe, effective,~     feasible, and acceptable for women and adolescents. A total of 400 female patients (ages~     15-44) requesting DMPA will be randomized to self-administration of DMPA sc or clinic~     administration (usual care). Subjects will be followed for one year. The primary study~     outcome is DMPA continuation at one year by self-report in both study arms. Secondary~     outcomes include patient-reported satisfaction with treatment; satisfaction with home use;~     and costs associated with contraceptive care. The investigators hypothesize higher~     continuation rates among self-injection users compared to patients who receive standard~     care. Secondary exploratory hypotheses include higher patient satisfaction and lower costs~     associated with contraceptive care among self-injection users.~   "
41808|NCT02509754|"~     Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share~     several physiopathological links. CHF patients present a significantly increased risk of~     developing AF and the related detrimental hemodynamic effects are even more relevant than in~     patients without CHF.~      Within CHF patients rate control is the most widely used strategy to manage AF, having~     proved non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic~     effects of AF persist, not contrasting the natural evolution towards progressive left~     ventricular (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy,~     instead, has shown, in the general population, advantages over rate control concerning~     survival, quality of life and thromboembolic events. The main limitation is that~     antiarrhythmic therapy used to achieve this goal has several side effects, and that~     transcatheter AF ablation has been assessed only in modest sample size studies.~      Available literature focusing on a direct comparison between two specific management~     strategies in patients with CHF and AF is limited to a small randomized study comparing~     pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF~     study). Additional indirect evidences may derive from meta-analyses of observational~     studies.~      The investigators therefore designed this multicenter, randomized controlled trial aiming to~     assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients~     with impaired LV function, AF catheter ablation is effective in improving LV function and~     clinical functional class, potentially driving to a reduction of device implantations~     (ICD/CRTs).~   "
41809|NCT02509741|"~     This research is aimed at verifying the effects of diets with high protein and low glycemic~     index (GI) on weight management among overweight or obese Chinese adult. Additionally, the~     investigators intend to verify the effects of two new approaches, including food replacement~     and Internet-of-things (IOT) monitoring on weight control.~   "
41810|NCT02509728|"~     To explore the effects of enteral choline and DHA supplementation on plasma choline and~     DHA-PC concentrations and metabolism, this randomized controlled study will assign 40~     preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA~     supplementation, and choline and DHA supplementation.~      After 7 days of supplementation, a single dose of stable isotope labelled choline will be~     administered and the kinetics of newly synthesized DHA-PC determined to assess plasma~     levels, uptake and distribution of choline and DHA.~      This study is designed to inform larger studies evaluating this approach of enteral~     co-application of choline and DHA on clinical important outcomes.~   "
41811|NCT02509715|"~     Effect of intraoperative nerve monitoring on voice quality during thyroid surgery~      Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and~     endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable~     decrease in the complication rates. In case of these advances, patients still have fear~     related with their voice. In this study, investigators aimed to investigate voice changes~     during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.~   "
41812|NCT02509702|"~     This study evaluates the effect of the mobile phone intervention 'Connected to Care' on the~     attendance rate to cervical cancer screening check-up appointments.~   "
41813|NCT02509689|"~     A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified~     that can overcome an existing barrier to the use of neurofeedback as a treatment technique~     in a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses~     the brain's own electrical activity as the training parameter. With sufficient practice, the~     brain can learn to change its own activity through finely tuned feedback using computerized~     sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment~     modality have been subject to a lack of standardization and have required significant~     expertise on the part of the provider. This new GZNT technology allows neurofeedback to be~     administered in a standardized and semi-automated fashion, which, if effective, will~     represent a significant advance toward providing this promising treatment modality to~     Service Members in a military or VA setting. This study will determine feasibility and~     preliminary evidence of efficacy for this neurofeedback technology in a pilot study of~     soldiers with medical issues associated with Traumatic Brain Injury (TBI). GZNT technology~     has the potential to provide a cost-efficient, non-invasive/non-pharmacological approach to~     recovery from impact and/or blast-induced brain injury, and holds promise to simultaneously~     address emotional symptoms that are often a part of the post-concussion symptom picture.~   "
41814|NCT02509676|"~     The purpose of this study is to investigate the effects of a 5-week dynamic stretching~     exercise training on muscle-tendon unit of gastrocnemius muscle.~   "
41815|NCT02509663|"~     The sinuplasty balloon offers a more physiological first of the sinuses which minimizes~     risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce~     the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative~     pain, ensure faster return to daily life activities (reduction of the average length of~     hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and~     reduction of post-operative pain score seams decrease on EVA.~      The economic impact of the sinuplasty balloon appears very favourable and fits into the~     strategy of development of the ambulatory practice.~   "
41816|NCT02509650|"~     The primary purpose of the protocol is to use next generation sequencing to identify~     pathogenic variants in genes involved in very rare skin diseases.~      The secondary purpose will be to study the genotype-phenotype correlation in order to~     re-evaluate the classification of these disorders. This work could help in the understanding~     of the physiopathology of very rare skin disorders.~   "
41817|NCT02509637|"~     Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of~     bronchi caused mainly by the perpetuation of inflammation and impaired clearance of~     secretions. Physical therapy is essential in the treatment of these patients, using its~     various techniques and devices. The aim of this study is to evaluate the impedance of the~     respiratory system, by impulse oscillometry, after breathing exercises with chest~     compression or flutter in patients with bronchiectasis, considering that there are no~     results in the literature on the effect of these techniques in the small airways of these~     patients.~   "
41818|NCT02509624|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of GS-4997 in~     adults with impaired hepatic function relative to matched, healthy controls. Each~     participant in the control group will be matched to a participant with impaired hepatic~     function by age (± 10 years), gender, and body mass index (± 20%).~   "
41819|NCT02509611|"~     The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e.~     reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the~     feasibility and acceptability of implementing a Hatha yoga program in PD subjects.~   "
41820|NCT02509598|"~     Open label, non-randomized, multi-center, within-subject comparative study to evaluate the~     tolerability and the diagnostic utility of Lymphoseek and compared with VBD in pediatric~     subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from~     neonatal through 17 years.~   "
41821|NCT02509585|"~     Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection~     of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a~     single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.~   "
41822|NCT02509572|"~     The goal of this trial is to test a novel means of collecting patient-entered sexual health~     information for the provision of clinical decision support to increase the testing and~     detection of sexually transmitted infections (STI) in adolescent emergency department (ED)~     patients at high risk for STIs.~   "
41823|NCT02509559|"~     The main objective of the present study is to combine two lines of research, investigating~     the interaction between emotional processing and memory performance (on both behavioral and~     electrophysiological levels) and its modulation by ß-blockade.~      Concerning pharmacological manipulations with ß-blockers, there are no studies, which~     investigated the effects of propranolol on electrophysiological (ERPs) and behavioral~     measures of recognition memory along with their codependence on individual variations of~     adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of~     ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.~      Therefore, the current investigation has been designed to replicate the former results which~     revealed reduced ERP correlates of recognition memory for emotional pictures due to~     administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether~     there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in~     memory performance and/or changes in event-related potentials and in propranolol influences~     on the above mentioned processes.~      In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing~     stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP,~     old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction~     of electrocortical correlates of emotional recognition memory (old-new effect) caused by~     propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the~     emotional information processing and memory formation alone, and on the propranolol~     modulation of those processes.~      Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol~     such as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary~     function and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.~   "
41824|NCT02509546|"~     This phase I/II trial studies the side effects and best dose of 8-chloro-adenosine and how~     well it works in treating patients with acute myeloid leukemia that has returned after a~     period of improvement (relapsed) or has not responded to previous treatment (refractory).~     Drugs used in chemotherapy, such as 8-chloro-adenosine, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading.~   "
41944|NCT02507973|"~     The investigators will conduct an observational crossover study. The investigators aim to~     recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial~     pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley~     Shock Trauma Center.~      Overall, participants will be monitored, on average, for approximately 6-8 hours during the~     study period. The investigators do not anticipate the need for prolonged monitoring during~     the duration of their hospital stay or post hospital period.~   "
41825|NCT02509533|"~     To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus~     usual dressing method. The VAC Therapy system consists of:~        -  A unit delivering a precise under atmospheric pressure, controlled and regulated in the~          wound site,~        -  Consumables necessary for the implementation of the dressing,~        -  Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It~          is known to be efficient into care of chronic wounds and ulcerous wounds by increasing~          the cicatrisation.~      This system is systematically used into the dermatology unit of the CHU of Saint-Etienne~     after transplants of leg ulcers, but no data confirms the interest of this method compared~     to usual dressing method. This study will provide this data.~   "
41826|NCT02509520|"~     Elderly patients who experience a prolonged ICU stay are at high risk for developing post~     intensive care unit syndrome (PICS), a serious medical condition manifested by loss of~     muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic~     disability, prolonged mechanical ventilation and the need for costly extended stays in long~     term care facilities (LTCs). The investigators' preliminary study shows attempts at~     rehabilitating patients who have already developed PICS are minimally effective, resulting~     in only modest improvements in functionality. This project will determine the effects of~     mobility-based physical rehabilitation (MPR) combined with neuromuscular electric~     stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on~     preventing PICS related musculoskeletal and functional deficits, and improving clinical~     outcomes.~   "
41827|NCT02509507|"~     This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene~     laherparepvec, injected intrahepatically, into liver tumors with known progression in~     subjects with Hepatocellular carcinoma and subjects with liver metastases from breast~     adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or~     squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell~     carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation~     consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in~     increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose~     determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated~     separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be~     deemed safe for non-hepatocellular carcinoma subjects before it will be administered in~     hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the~     Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A~     (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects~     for each tumor type.~   "
41828|NCT02509494|"~     The purpose of this study is the evaluation of the safety and immunogenicity of two~     candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.~   "
41829|NCT02509481|"~     The purpose of this study is to determine whether repeated ivermectin mass drug~     administrations to Burkinabé villagers, performed in three week intervals over the~     rainy-season, is well-tolerated and safe, and also effective in reducing local malaria~     transmission and thus clinical malaria episodes in treated village children.~   "
41830|NCT02509468|"~     The most recent classification, adopted by International Society for the Study of Vascular~     Anomalies (ISSVA) in 1996, and updated in Melbourne in 2014, divides these lesions into two~     broad categories: vascular tumors and vascular malformations. Vascular malformations (VMs)~     are subdivided into high-flow VM and slow-flow VM.~      Slow-flow VMs consist of congenital anomalies which may involve abnormal capillaries~     vessels, venous vessels, lymphatic vessels or combination of several of them. They can be~     superficial (involving cutaneous and subcutaneous tissues) and/or may have visceral~     involvement. They can be limited or diffuse, and are sometimes components of genetic~     hypertrophic syndromes.~      The diagnosis of slow-flow VMs is performed on physical examination (biopsy may be required~     for confirmation), and is completed with imaging (ultrasonography and magnetic resonance~     imaging (MRI)). Slow-flow VMs may be particularly voluminous; associated with underlying~     hypertrophy responsible for functional impairment; painful; associated with seepage or~     continuous cutaneous bleeding; complicated with visceral signs or hematologic disturbances~     (anemia, thrombopenia). Management requires dedicated multispecialty care. There are no~     guidelines for treatment, and management may include no intervention - but natural history~     of these VMs is progressive worsening -, compression by physical bandage, sclerotherapy,~     resection (when feasible),anti-inflammatory or anti-coagulation drugs.~      Case reports and series have provided evidence for supporting the need for a clinical trial~     of sirolimus by reporting successful treatment on several children with complicated vascular~     anomalies. The choice of sirolimus is rational. Mammalian target of rapamycin (mTOR) is a~     serine/threonine kinase regulated by phosphoinositide-3-kinase involved in cell mobility,~     cell growth and angiogenesis. Sirolimus inhibits mTOR, which induces inhibition of~     angiogenesis, in particular lymphangiogenesis, which has been demonstrated in several~     models.~   "
41831|NCT02509455|"~     To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand~     management purposes), has the same trunk sway measures similar normal reference values of~     SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data~     obtained by SwayStar, a highly accurate and widely accepted system for measuring balance~     control.~   "
41832|NCT02509442|"~     This study is about an experimental biomedical monocentric search concerning twelves~     patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery~     awakened on the site of the CHU of Montpellier.~      The objective of this search is to understand exactly how the electric impulses, delivered~     by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by~     tumors infiltrates of low rank, propagate in this one and to identify the nervous networks~     inhibited by these electric impulses.~      Having verified the eligibility of the patients and having obtained their consent, they will~     be included in the study. Before the beginning of the surgery, the electroencephalography~     activity of the brain of every patient will be recorded. Before and after the surgical~     resection, the electrocorticography activity will be recorded.~      The collected data will then be analyzed, after the operation. Analyses will try to identify~     what we call potential evoked by the stimulation and which are small electric waves which~     appear after the electric stimulation was delivered.~   "
41833|NCT02509429|"~     The objective of this study is to assess the efficacy of an Artificial Pancreas system which~     includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold~     Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical~     centres. After a 2 week run-in period, they will attend two investigational sessions of 65~     hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will~     be activated, depending on the randomization. The main endpoint is the time spent below~     70mg/dL between 22:00 and 07:00.~   "
41834|NCT02509416|"~     The establishment of a number of training programs in therapeutic endoscopy, standardization~     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde~     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The~     length of training and minimum number of procedures, requisite theoretical learning and~     methodology to define competence in EUS and ERCP are not well defined. The investigators~     research has demonstrated that individuals in training acquire skills at different rates and~     the number of procedures completed alone is a suboptimal marker for competency in a given~     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed~     to performance metrics with well-defined and validated thresholds of performance.~     Multicenter prospective data are needed to help guide development of competency based~     medical education that define learning curves in EUS and ERCP and set evidence-based~     benchmarks required to achieve competence using a validated competency assessment tool.~      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment~     tool will allow for reliable and generalizable standardized learning curves, competency~     benchmarks and creation of a centralized national database that compares a trainee's~     performance amongst peers.~   "
41835|NCT02509403|"~     The purpose of this study is to assess the safety (absence of skin irritation) of a feminine~     hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial.~     The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.~   "
41836|NCT02509390|"~     Assessment of the evolution of fibrinogen plasma level within the first ten days after major~     trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to~     onset.~   "
41837|NCT02509377|"~     Inclusion and exclusion criteria for fetal repair of MMC was established by the Management~     of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care~     throughout the United States. These criteria state exclusion for hypertension and diabetes~     which are known co-morbidities for obesity. Investigators plan to expand one exclusion~     criteria for open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of~     35.0 and greater.Investigators will maintain all other inclusion and exclusion criteria~     (including excluding for hypertension and diabetes) with the exception of expanding the BMI~     to include mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be~     compared to the comorbidities of the mothers published in the MOMS trial.~   "
41838|NCT02509364|"~     Idiopathic pulmonary fibrosis (IPF) is a highly heterogeneous and lethal pathological~     process with limited therapeutic options, which is the most common and severe of the~     idiopathic interstitial pneumonias (IIPs). During the past 20 years, the incidence of IPF~     increased significantly. Most of IPF patients show a median survival time of 2-3 years after~     diagnosis. Five-year survival rate is 30%-50%. It's difficult to diagnose in the early stage~     of IPF. Once the patients go to hospital, it's already in the late stage. Now there is no~     effective therapy except lung transplant for IPF in clinical application.~      Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a fatal condition with high~     mortality (over 80%). Its etiology and pathogenesis remain unknown. There is a lack of~     effective treatment for it. Based on the investigators' long-term clinical observation, most~     cases of AE-IPF initially got common cold and had coryza, more cough, nasal~     obstruction，rhinorrhea, sore throat, some patients had fever, headache, and etc. Some of~     these patients' condition developed very rapidly and then became very severe similar to the~     situation of acute respiratory distress syndrome (ARDS). Why these AE-IPF patients were so~     hypersensitive to cold? What were the immunologic and pathological mechanisms of their~     lung lesions after patients exposed to common cold? How to effectively offer~     interventional treatment for AE-IPF? All the above questions are yet to be explained~     clearly.~      In the investigators' previous retrospective study, the investigators found that there were~     some obviously imbalanced immune responses in IPF patients, including increased cluster of~     differentiation 4 (CD4) T cell population, immunoglobulin and complements. The investigators~     also found highly expressed inflammatory cytokines (IL-17, MIG and IL-9) and high detection~     rates of pathogens in AE-IPF patients, especially serum immunoglobulin M (IgM) antibody of~     some respiratory virus. These findings provide a strong suggestion that there are some~     imbalance of immunologic function in IPF and there are relationship between AE-IPF and~     infection, especially Cold virus infection might be a key trigger for AE-IPF.~   "
41839|NCT02509351|"~     -  Misoprostol reduces the uterine bleeding after cesarean delivery without harmful~          effects on either mother or baby.~        -  The aim of the this study is to address if there is any benefits 'regarding the~          intra-operative blood loss' from preoperative rectal administration of 400 mic of~          Misoprostol in addition to the routinely administrated 10 units of oxytocin~   "
41840|NCT02509338|"~     The main objective of the trial is to study the technical feasibility of the implantation of~     a new electrode Monocontact deep brain stimulation electrode in dystonia.~   "
41841|NCT02509325|"~     The purpose of the study is to investigate the feasibility of using the commercially~     available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor~     fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of~     motor fluctuations would support the general neurologists in the referral of PD patients to~     the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility~     evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.~   "
41842|NCT02509312|"~     This is a randomized, double blind placebo trial to evaluate whether ketorolac given at the~     time of cord clamp has any impact on post-partum pain control. Patients will be randomized~     to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive~     ketorolac at cord clamp and 3 additional doses 6 hours apart (total 4 doses/24 hours). Those~     in the placebo group will receive placebo medications during those time periods.~   "
41843|NCT02509299|"~     Chronic obstructive pulmonary disease (COPD) impacts negatively on the quality of life of~     patients. Several studies have shown that acute exacerbations (AEs) decrease health-related~     quality of life, pulmonary function and survival of COPD patients.~      The objective of the present study is to examine the effects of a physical therapy program~     on perceived health status in COPD patients hospitalized due to an acute exacerbation.~   "
41844|NCT02509286|"~     The trial is designed to investigate differences in outcome of patients with esophageal~     adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant +~     adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation~     (CROSS) plus surgical resection.~   "
41945|NCT02507960|"~     In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma~     Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in~     15 fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy~     will be the surgical cavity as defined by the surgical clips and post-surgical changes + 5~     mm. The planning target volume (PTV) will add 5 mm to the clinical target volume to account~     for geometric uncertainties.~   "
41845|NCT02509273|"~     Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine~     (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18~     years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical~     ventilation and sedation for at least 24 hours.~      In particular, the proportion of subjects with sedation failure at the maximum possible dose~     (defined within the study protocol) will be measured. Additionally, the safety and~     tolerability (including withdrawal effects) of clonidine compared to midazolam will be~     evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU~     will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics,~     pharmacodynamics and metabolism will be also identified.~      Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be~     manufactured. At least 300 subjects will be enrolled from study centres in five European~     member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden).~      The clinical study will enrol critically ill paediatric patients who require mechanical~     ventilation and sedation.~      Subjects will be closely followed using standard PICU monitoring of vital functions~     (continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent~     assessment of systolic and diastolic blood pressure), intermittent assessment of pain and~     depth of sedation, documentation of parameters of mechanical ventilation and intermittent~     arterial blood gas analysis.~      The study will be conducted in compliance with the study protocol, Good Clinical Practice~     (ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff~     will be monitoring subjects around the clock, thus minimising reaction time in case of~     alarms or deterioration of clinical parameters.~      This project has received funding from the European Union's Seventh Framework Programme for~     research, technological development and demonstration under grant agreement n° 602453.~   "
41846|NCT02509260|"~     Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and~     Medicaid Services introduced the Surgical Care Improvement Project infection project with~     the aim of reducing SSI incidence and morbidity. These measures include prophylactic~     intravenous antibiotics administered within 1 hour of skin incision, appropriate~     prophylactic antibiotic selection, discontinuation of prophylactic antibiotics within 24~     hours after surgery, appropriate hair removal, and maintenance of perioperative~     normothermia. Despite the enforcement of these measures through quality reporting and~     pay-for-performance measures, significant controversy exists as to their overall~     effectiveness, especially in the high-risk colorectal surgical population. Laparoscopic~     surgery has been shown to improve SSI rates in the colorectal population; however, not all~     patients are appropriate candidates for this approach and the inability of promising~     interventions such as wound edge protection and gentamicin sponges to improve SSI rates~     following colorectal surgery mandate the investigation of novel techniques.~      The aim of the current study is to assess the clinical effectiveness of incisional NPWT to~     reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this~     study is the occurrence of superficial SSI within 30 days after surgery and the secondary~     endpoints include length of hospital stay and cost effectiveness.~   "
41847|NCT02509247|"~     Wireless telemonitoring was used during the habituation phase of continuous positive airway~     pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were~     allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing~     time, patient satisfaction and treatment efficiency and efficacy were compared between the~     groups at baseline and after one year treatment the CPAP adherence and treatment efficacy~     were recorded.~   "
41848|NCT02509234|"~     The purpose of the study is to evaluate patients with refractory childhood sarcomas, who~     have been treated with a combination therapy of trabectedin and irinotecan (within~     compassionate use), to determine, if this is a promising treatment option with acceptable~     toxicity and if the results warrant a prospective study.~   "
41849|NCT02509221|"~     Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with~     Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to~     the surgical site, but may also lead to the accidental removal of surgical dressings, IV~     catheters, and drains. is one of the The purpose of the study is to find whether duration of~     exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.~   "
41850|NCT02509208|"~     The purpose of this European study is to demonstrate the safety and performance of the~     SurgiClot® dressing in the treatment of cancellous bone bleeding.~   "
41851|NCT02509195|"~     The purpose of this study is to identify the effects that ageing may have on the drug~     levels, the safety and the efficacy of Dolutegravir.~      These effects will be measured in people who are aged 60 or over and taking antiretroviral~     therapy for HIV infection.~      Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs~     called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and~     Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data~     available on Dolutegravir in the context of older age. The HIV population is ageing and the~     investigators know that older age can significantly change the effects and side effects of~     medications, including that of antiretrovirals.~      The investigators aim to investigate the treatment outcomes in older people taking~     Dolutegravir including the tolerability, efficacy and safety of the drug.~      The study will also assess the quality of life (wellbeing of individuals) and cognition~     (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this~     study may inform treatment choices and monitoring in this population in the future.~      The duration of involvement in the study will be 6 months with an additional screening visit~     and a checkup visit 10 days after end of study visit.~   "
41852|NCT02509182|"~     The purpose of this study is to test the hypothesis that decreasing the inspired oxygen~     concentration during thoracic surgery requiring one lung ventilation will improve~     post-operative oxygenation.~   "
41853|NCT02509169|"~     An open-labeled, randomized, active-controlled phase II study to investigate clinical~     efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with~     p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).~   "
41854|NCT02509156|"~     The primary purpose of this study is to examine the safety and feasibility of delivering~     allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer~     survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced~     cardiomyopathy (AIC).~      The secondary purpose of this study is to obtain preliminary evidence for therapeutic~     efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV~     dysfunction secondary to AIC.~   "
41946|NCT02507947|"~     SPECTAmel is a standardized, quality-assured molecular screening platform for tumor~     characterization and storage of human biological material (HBM) for the purpose of~     integrating new biomarkers into clinical trials and optimizing access of patients to~     therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are~     collected from consenting patients.~   "
41855|NCT02509143|"~     Objectives: This study aims to assess the effectiveness, safety, and feasibility of~     intensive acupuncture treatments combined with standard antiemetic medication as compared~     with P6 acupoint stimulation combined with standard antiemetic medication or with standard~     antiemetic medication alone, to prevent postoperative nausea and vomiting (PONV) in patients~     undergoing laparoscopic colorectal surgery.~      Background: PONV is one of the prevalent discomforts in the early phase of recovery after~     surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the~     occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces~     more benefits compared with P6 stimulation alone or whether acupuncture combined with~     standard antiemetic medication yields better outcomes. This study aims to assess the~     effectiveness and safety of different acupuncture regimen for the prevention of PONV:~     high-dose acupuncture treatments combined with standard antiemetic medication, P6~     acupuncture-point stimulation combined with standard antiemetic medication, or medication~     alone.~   "
41856|NCT02509130|"~     MISSION is a new and novel way of delivering highly specialised asthma care and has the~     potential to change the way asthma care across the United Kingdom (UK) is delivered as well~     as services for other long term health conditions. The MISSION model is the first model of~     this type and the current research study aims to evaluate its success and to compare the~     MISSION service to current care delivery. This will be done in several different ways. The~     study is a mixed methods evaluation of the new service comparing outcomes before and after~     the intervention using retrospective data analysis and prospective qualitative interview. A~     control arm of patients not exposed to, but eligible for, the new intervention will also be~     included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS)~     Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics,~     staff who attended MISSION clinics in a professional capacity and patients from GP surgeries~     where MISSION clinics were held who did not attend.~   "
41857|NCT02509117|"~     The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979~     following oral doses in healthy adult and healthy elderly subjects.~   "
41858|NCT02509104|"~     The primary objective of this study is to determine the bioavailability of a FDC capsule~     formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative~     to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet~     in healthy male subjects in fed and fasted states. This is an open-label, randomized, single~     dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1)~     and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride~     0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the~     coadministration of dutasteride and tamsulosin hydrochloride in a different treatment~     period. Each subject enrolled will be allowed to participate in only one cohort (i.e, will~     receive treatment under fasted or fed conditions) and will participate in both treatment~     periods. The two treatment periods will be separated by a minimum washout period of 28 days.~     The total duration in the study for each subject will be approximately 2.5 months from~     screening to the final follow-up visit.~   "
41859|NCT02509091|"~     The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment~     of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical~     Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in~     Patients with Acute Exacerbation of Bronchiectasis.~   "
41860|NCT02509078|"~     This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a~     patient with acute respiratory distress syndrome will improve survival. Half of the patients~     will receive a neuromuscular blocker for two days and in the other half the use of~     neuromuscular blockers will be discouraged .~   "
41861|NCT02509065|"~     The current study is designed to determine the effect on mean glucose, hypoglycemia,~     glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal~     bionic pancreas, and determine whether there is a target at which adequate glycemic control~     is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.~   "
41862|NCT02509052|"~     This phase I/II trial studies the side effects and best dose of leflunomide in treating~     patients with multiple myeloma that has come back (recurrent) or has not responded to~     previous treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
41863|NCT02509039|"~     To determine the safety and tolerability of CC-122 when administered orally to adult~     Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define~     the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).~   "
41864|NCT02509026|"~     The purpose of this study is to study the benefits and risks of etanercept withdrawal in~     patients who have achieved a significant clinical response.~   "
41865|NCT02509013|"~     This is a prospective, multi-center, hospital-based observational study. The aim of the~     study is to evaluate the prevalence of chronic kidney disease in patients with stable~     coronar heart disease.~   "
41866|NCT02509000|"~     This study aimed to assess the impact of air filtration on indoor air quality and~     cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.~   "
41867|NCT02508987|"~     The aim of the study is to evaluate the effect of obesity on periodontally healthy or~     diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical~     periodontal status was determined through plaque index, gingival index, bleeding on probing,~     pocket probing depth, clinical attacment level and radiographs.~      Oxidative stress is known to contribute to various diseases by affecting cellular functions~     through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by~     measuring the products of oxidative damage found in proteins, lipids and DNA or reductions~     in total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant~     capacity levels are biomarkers of oxidative stress in gingival crevicular fluid.~   "
41868|NCT02508974|"~     Malnutrition of patients on admission to hospitals are estimated to be as high as 60%,~     although the prevalence varies between countries. The impact of malnutrition on patient~     recovery and discharge is severe, with extensive cost implications. This study aims to~     assess the prevalence of at risk for malnutrition among adult patients admitted to hospital~     across 3 countries on the African continent.~   "
41963|NCT02507726|"~     This study evaluates the performance of a new 1-piece ostomy convex appliance in patients~     with enterostomy.~   "
41869|NCT02508961|"~     The study will be a pragmatic, single blind, randomised, controlled feasibility study,~     comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS.~     The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and~     Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.~      The aim of this study is to assess the feasibility of a randomised controlled trial~     examining the effectiveness of a six-month web-based physiotherapy programme and usual care~     compared to usual care alone, in people moderately affected by MS and to gather essential~     information for the planning of a definitive trial, which would evaluate both clinical and~     cost effectiveness of the intervention.~   "
41870|NCT02508948|"~     To further examine current intubation practice among critically ill patients who are in need~     of endotracheal intubation, the investigators plan to perform a prospective cross-sectional~     study of adult critically ill patients who needed endotracheal intubation at participating~     sites between August 1st, 2015 to August 1st, 2016. The investigators aim to describe the~     current intubation practice among the participating sites with a description of~     complications that may have surfaced during the peri-intubation period and to isolate~     predictive factors of these complications.~      In this study, the primary aim is to describe, through a prospective cross-sectional study,~     the current intubation practice of adult critically ill patients undergoing endotracheal~     intubations with secondary aims exploring complications that may emerge during the~     peri-intubation period and to isolate predictive factors of these complications. This~     information will generate hypotheses which will lead to further study with the ultimate~     impact of reducing patient-related outcomes such as morbidity and mortality.~   "
41871|NCT02508935|"~     Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and~     safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate~     to severe acute pain. The study will assess the safety of administering multiple doses of~     XARTEMIS XR in this population.~   "
41872|NCT02508922|"~     To build on a recent case study and open label trial, the investigators want to find out if~     vitamin D supplementation can influence behavioural and core symptoms of autism.~   "
41873|NCT02508909|"~     Groin lymph node dissection for melanoma patients is burdened by high post-operative~     morbidity, mainly related to wound. This is a prospective pilot trial investigated~     feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in~     patients with inguinal lymph node melanoma metastases.~   "
41874|NCT02508896|"~     Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel~     group, phase I clinical trial of repeated administration by subcutaneous injection of a~     single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting~     AFFITOPE® vaccines or Placebo. This study will assess Safety, Immunogenicity and low density~     lipoprotein cholesterol-lowering activity of the two vaccines.~      72 healthy subjects are divided into three test groups (2 treatment groups, 1 placebo~     group), each consisting of 24 subjects. The subjects are randomized to receive either of two~     AFFITOPEs® (AT04A or AT06A, adsorbed to 1 mg aluminium oxyhydroxide) or placebo (1 mg~     aluminium oxyhydroxide).~      The study consists of 3 parts, part A, encompassing Visit 1 to Visit 8, covering 3 priming~     immunizations at a dose of 15μg at days 0, 28 and 56 and the immediate observation period~     extending to day 140; the prolonged observation period: part B, encompassing Visit 9 and~     Visit 10 at days 273 and 365; and part C consisting of 7 visits (V11 to V17). Study~     participants having received 3 priming vaccinations and having completed part B will receive~     in part C one boost immunization at a dose of 75μg, which will be applied one year after the~     3rd immunization (day 420). Probands will proceed directly from part A to part B and to part~     C. Continuation of parts B and C will be considered based on the part A results, primarily~     the immunological results. The following scenarios apply (provided that there is no safety~     issue). None of the two treatment groups exhibits a vaccine-specific antibody response over~     the placebo group at Visit 8 - this will lead to termination of the trial. One of the two~     groups fails to exhibit a vaccine-specific antibody response over the placebo group at Visit~     8 - this will lead to its discontinuation; the other treatment group and the placebo group~     will be continued.~   "
41875|NCT02508883|"~     This is a prospective and observational study to evaluate oncologic patients that presented~     upper gastrointestinal bleeding with the use of some prognostic scores.~   "
41876|NCT02508870|"~     This is a non-randomized, open-label, Phase 1 study of Atezolizumab (MPDL3280A, Anti-PD-L1~     antibody) monoclonal antibody [mAb] in intermediate/high/very high-risk myelodysplastic~     syndromes (MDS) patients, as evaluated by the International Prognostic Scoring~     System-Revised (IPSS-R). Eligible participants will either have never received treatment~     with hypomethylating agents(s) (HMAs) or have relapsed or are refractory to prior HMA~     therapy. The primary objectives of this study are to determine the safety and feasibility of~     Atezolizumab therapy in these patient populations, including treatment in combination with~     azacitidine.~   "
41877|NCT02508857|"~     Magnesium sulfate has been reported to improve postoperative pain, but evidence is still~     controversial. Some studies demonstrated benefits while others concluded that there is no~     efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of~     magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods:~     We designed a double-blind randomized controlled trial that compared intravenous magnesium~     sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and~     opioid related side effects.~   "
41878|NCT02508844|"~     The purpose of the study is to investigate if the probiotics Vivomixx® can affect~     gestational weight gain, microbiota and pregnancy complications in pregnant obese women and~     birth weight body composition of their infants.~   "
41879|NCT02508831|"~     The case of patients with amputation of forearm on one side and arm on the other is~     particularly interesting to study because in this situation of handicap greater than a~     double amputation in forearm. We should bring a functional benefit to the patient with the~     transplant of forearm and this situation allows to have the best possible control to compare~     the result of the transplant of arm to that of forearm because it is realized at the same~     patient.~      Amputation of both arms deprives patients of an elbow what establishes a major factor of~     limitation of autonomy and makes patients totally dependent for the realization of the~     essential gestures of the current life requiring the prehension (dress, dressing, food,~     hygiene of the elimination). The various equipments are not always adaptable and usable.~     Psychologically, an amputation in arm is unanimously considered as an infringement very~     badly accepted of the physical integrity and establishes a major handicap factor of family,~     professional and social exclusion.~      The results of this study should allow a better appreciation of indications and modalities~     of care of biamputed patients with at least one lesion level above the elbow.~      This clinical research will determine the potential place of a reconstructive surgery as~     allograft in biamputed patients on the basis of functional results and assessment of~     disorders of the body schema perception.~   "
41880|NCT02508818|"~     There are no equivalent experiment setups to create comparable changes of gravitation such~     as during parabolic flights. To determine the initial orthostatic responses of the~     cardiovascular system under the gravitational conditions of mars and moon is an essential~     step for a better understanding of 1) the fundamental functions of the human cardiovascular~     system (basic research) 2) specific impact of partial-g on the human heart, lungs and~     vessels in a spaceflight-context 3) approaches for countermeasure development against~     orthostatic intolerance on moon and mars (applied research).~      Non-invasive measurement methods will be used to achieve the cardiovascular key values of~     the study: stroke volume (SV) and cardiac output determination by pulse contour analysis,~     impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure~     measurement, heart rate and heart rate variability determination by ECG. All of these~     methods have proven their accuracy during parabolic flights. Nevertheless pulse contour~     analysis and impedance cardiography are known to provide only relative SV and CO values.~     Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and~     cardiac outputs to absolute values. Success of this procedure was shown during former~     parabolic flights.~   "
41881|NCT02508805|"~     The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for~     injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard~     therapy. The patients are randomised into two groups: standard therapy group and standard~     therapy plus Neuromultivit group.~   "
41882|NCT02508792|"~     Heart failure (HF) is an important public health problem being considered an emerging~     epidemic, therefore, strategies are essential to improve symptoms and to decrease the money~     expenditure on healthcare. Based on the knowledge about the syndrome of heart failure, new~     approaches are needed to decrease the symptoms, to enhance the quality of life of these~     patients and highlight the non-pharmacological therapies such as the use of phototherapy.~     The objective of this study is to study the effect of low level laser therapy in muscle~     function and tissue oxygenation of the lower limbs in patients with heart failure. It is a~     randomized, double-blind, including 20 individuals with heart failure, with stable, class II~     or III according to the New York Heart Association (NYHA). It will be evaluated the acute~     effects of a LASER intervention applied before a fatigue protocol throught muscle function~     and tissue oxygenation in the participants. Evaluations will be performed by an isokinetic~     dynamometer, near infrared spectroscopy (NIRS) and electromyography . It will be analyzed~     the concentration of oxyhemoglobin and deoxyhemoglobin, total hemoglobin concentration, the~     difference between these concentrations, muscular torque, fatigue index and muscle~     activation. The data will be subjected to distribution normality test and if they have~     normal distribution, the differences between the interventions will be checked by analysis~     of variance, considering significant ap <0.05. If the data is non-parametric distribution~     will be using the Mann-Whitney or Kruskal-Wallis. The SPSS 19.0 software will be used as a~     tool for data analysis. The investigators expected to find as outcomes of this study an~     increase in peripheral muscle function and tissue oxygenation and also a delay in the~     development of muscle fatigue in patients with HF submitted to acute intervention with~     LASER.~   "
41883|NCT02508779|"~     Ineffective management of blood glucose (BG) levels during preconception and pregnancy has~     been associated with severe maternal and fetal complications in women with type 1 diabetes~     (T1DM). Preconception care emphasizing stringent glycemic control in the preconception~     period and continued through early pregnancy can dramatically reduce these risks. However,~     the use of preconception care in the US has been disappointingly low due to a variety of~     organizational, provider, and patient centered factors. Furthermore, efforts to achieve~     tight glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women,~     potentially leading to serious health consequences. In this project, the investigators will~     test an education based Internet intervention (Bump2be or Blood glucose awareness training~     (BGAT) for users who might become pregnant) for use with T1DM women who are either actively~     trying to become pregnant (TP) or planning to become pregnant in the 12 months following~     their enrollment in this study (PP).~      The main objective is to examine Bump2be's feasibility and preliminary efficacy as an~     intervention for these women to better regulate their BG levels and to meet their~     diabetes-related clinical targets for pregnancy. More specifically, Bump2be will be tested~     in a randomized clinical trial in which 58 T1DM women who are either TP or PP will be~     recruited. As part of this pre-post study design, participants will be randomly assigned to~     either the Bump2be intervention (n=29) or the routine care group (n=29). Data collected will~     include frequency of extreme BG, consequences of extreme BG, average BG levels (HbA1c~     level), estimation of BG, detection of low and high BG, and psychological functioning~     (including fear of hypoglycemia, avoidance of hyperglycemia, well-being, and internal locus~     of control). Interviews with up to 10 trial participants will be conducted at the conclusion~     of their study participation, to enable further optimization of the intervention in~     preparation for a subsequent R01 submission. This will be the first study investigating the~     use of the Internet to improve detection and management of extreme BG levels in Diabetes~     mellitus type 1 (T1DM) women who are either TP or PP.~   "
41884|NCT02508766|"~     The primary purpose of this study was to examine the immediate effect of manual stimulation~     on the foot plant in static and dynamic balance in young healthy subjects. In addition, the~     secondary objectives of this study were: 1) to identify whether manual stimulation of the~     foot plant in healthy young subjects, carried out with an easily reproducible protocol with~     10 minutes duration, improves static balance, measured with Unipedal Stance Test; 2) to~     assess whether, manual stimulation of the foot plant in healthy young subjects, carried out~     with an easily reproducible protocol with 10 minutes duration, improves dynamic balance~     test, measured with Star Excursion Balance Test.~   "
41885|NCT02508753|"~     The purpose of the study is look at the possible side effects of two different doses of~     CXA-101/tazobactam, a low dose and a high dose, on participant's heart.~   "
41886|NCT02508740|"~     The purpose of this study is to characterize the effect of renal function on the PK of a~     0.25 mg single oral dose of bevenopran in humans and to assess the safety and tolerability~     of bevenopran in patients with varying degrees of renal impairment and in healthy subjects.~   "
41887|NCT02508727|"~     Cardiac exploration almost systematically requires the acquisition and / or calculating~     function indices. The ejection fraction (LVEF) is probably based index most widely used in~     all cardiac exploration methods. This relatively universal overall index has very many~     qualities. LVEF is widely used in clinical practice through the exploration and monitoring~     of all heart disease.~      Current progress in the management of various cardiomyopathies pass through the detection of~     early attacks. This testing often takes place upstream changes in LVEF that remains long~     normal or normalized. Sensitive indicators capable of detecting early abnormalities of~     regional functions are essential in addition to conventional echocardiography. Various~     studies have shown the contribution of these new markers in early detection of abnormalities~     of the cardiac function. The most widely used indicator in these studies because of its high~     sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler~     however has limitations in particular its dependence on the incident angle, which makes it~     impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.~      A new way of exploring the regional function of the heart, speckle tracking, can analyze~     heart deformations along the principal axes of the heart. The advantage of this technique~     has been shown in various pathological situations. Currently, this technique is mostly used~     in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this~     technique is not currently known, acquisition of 3D technology is recent (2004) and~     dedicated software is confidential dissemination and unvalidated.~      The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In~     the 90s, studies have demonstrated the feasibility of this technique, the ability to access~     all of the myocardial deformation in space and to define normal values. The cost of the~     procedure, duration, limited accessibility and post-processing very time consuming limited~     the scope of the clinical benefits of this modality.~      Echocardiography has major advantages over MRI, particularly its high availability, low cost~     and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is~     a new opportunity that it is essential to validate.~      The main purpose of the study is to compare the strain values obtained 3D ultrasound to~     those obtained by MRI tagged in a control group and a group of subjects with an anterior~     infarction sequela.~   "
41888|NCT02508714|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease~     has led to a significant reduction in morbidity. However, the first generation of these~     devices had no positive impact on the mortality after PCI (compared to bare metal stents),~     which was greatly attributed to a somewhat increased incidence of late and very late stent~     thrombosis. Concerns about the role of durable polymers as a potential trigger of~     inflammation and finally adverse events also led to the development of DES with~     bioresorbable coatings, which leave after degradation of the coating only a bare metal stent~     in the vessel wall that does not induce an inflammatory response. While such bioresorbable~     polymer DES are increasingly used in clinical practice, data from head-to-head comparisons~     between bioresorbable polymer DES with a contemporary highly flexible new generation~     permanent polymer coated DES.~   "
41889|NCT02508701|"~     This is a study testing what type of message and access influences a young male to get the~     HPV vaccine.~      The investigators are conducting a 2 X 2 design~      These conditions are:~        -  Condition 1: Altruistic personal with direct recommendation inside-dorm~        -  Condition 2: Generic message with inside-dorm~        -  Condition 3: Generic message with outside-dorm HPV vaccine~        -  Condition 4: Altruistic personal with outside-dorm HPV vaccine~      The objectives of this study are:~      A. To examine the efficacy in encouraging young men to receive HPV shots at Time 1 within~     each of the four intervention conditions (altruistic/personal with direct recommendation vs.~     generic message) X (in-dorm vs. outside-dorm HPV vaccine).~      B. To examine the efficacy in encouraging young men to receive HPV shots at Times 2 & 3~     within each of the four intervention conditions (altruistic/personal with direct~     recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).~      2.1.1 List the clinical hypotheses. Objective A H A.1: At Time 1, college men who have~     immediate access to the HPV vaccination will take the vaccination at a higher rate than~     those who do not have immediate access to the vaccine.~      H A.2: At Time 1, college men who receive an altruistic/personal health message along with~     immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the~     men in the other three arms of the study.~      Objective B H B.1: At Times 2 & 3, college men who have immediate access to the HPV~     vaccination will take the vaccination at a higher rate than those who do not have immediate~     access to the vaccine.~      H B.2: At Times 2 & 3, college men who receive an altruistic/personal health message along~     with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than~     the men in the other three arms of the study.~   "
41890|NCT02508688|"~     The management of refractory hepatic hydrothorax is challenging and usually unsuccessful.~     The study will discuss the perioperative treatment, effectiveness, and morphology of~     diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors~     associated with increased three-month mortality in these critically ill patients will be~     studied.~   "
41891|NCT02508675|"~     The major aim of this project is to investigate the prevalence, recovery patterns and risk~     factors for health related quality of life functional, psychological, societal and economic~     outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref)~     questionnaire for the trauma population.~   "
41892|NCT02508662|"~     Objectives:~      Primary Objectives:~      To evaluate the anti-cancer activity of commercially available, targeted anti-cancer~     therapies used off-label for treatment in patients with advanced solid cancer with known~     genomic aberrations.~      Secondary Objectives:~      To determine outcomes of patients who were treated with matched targeted anti-cancer~     therapies based on known genomic aberrations.~      To obtain treatment related adverse events in patients with advanced solid tumor who were~     treated with off -label targeted therapies.~      To determine co-genomic aberrations that may contribute to treatment response or resistance~     mechanisms.~      To determine feasibility of detecting the genomic alterations in plasma, and the genomic~     evolution of circulating biomarkers.~   "
41893|NCT02508649|"~     This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial.~     The trial is designed to investigate the efficacy and safety of multiple dosing regimens of~     selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of~     adult patients with septic shock requiring vasopressor.~   "
41894|NCT02508636|"~     This is a phase II study to evaluate efficacy, safety, toxicity, and feasibility of the~     addition of enzalutamide to leuprolide for a total duration of 24 months in patients with~     very high-risk prostate cancer or pelvic node positive disease receiving radiotherapy. Very~     high-risk prostate cancer is defined as 2 or more of the following characteristics: 1)~     cT3a/b, 2) PSA ≥20 and <150, 3) Gleason 8-10, and 4) ≥33% core involvement.~   "
41895|NCT02508623|"~     The purpose of this study is to assess whether the add of Rifaximin in patients with liver~     cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads~     to a significant reduction of portal hypertension.~   "
41896|NCT02508610|"~     This is protocol is generated in response to the exploratory R21 from the National~     Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for~     US-Russia collaborative research in HIV/tuberculosis (TB). Given the exploratory focus of~     the protocol and the short time frame of funding (2 years) we will study TB in Irkutsk, in~     Eastern Siberia. Irkutsk is one of the hardest-hit areas in all of the Russian Federation~     for drug-resistant TB and poor TB outcomes. Specifically, the investigators will examine the~     factors of anti-TB drug pharmacokinetics, TB drug-resistance mutations and~     virulent/transmissible M. tuberculosis sublineages. This foundational work will inform~     future diagnostic strategies and therapeutic regimens.~   "
41897|NCT02508597|"~     Physicians play a critical role in reducing tobacco use by advising smoking patients to~     quit. After receiving such advice to quit smoking, patients were more likely to report~     trying to quit, quitting for at least 24 hours, making more quit attempts, and having more~     successful quitting outcomes compared with those who received no such advice. On the other~     hand, most physicians are not performing smoking cessation counselling, and miss the~     opportunities to advise patients to quit smoking. One of the common reasons is the lack of~     time. Physicians are busy and cannot afford even one minute to advice their patients to quit~     smoking. Other barriers include lack of training and experience, lack of knowledge and~     skills, no awareness about the benefits and effects of physicians' advice, no incentives and~     no support or requirement from hospital management that they have to do it.~      We designed a brief smoking cessation counselling model (AWARD) which takes only 10-20~     seconds. We will train the physicians to perform the AWARD cessation counselling model in~     clinic, and encourage them to participate in our brief smoking cessation intervention~     project using the randomized controlled trail (RCT) design and to train more peer physicians~     to perform brief smoking cessation counseling. We propose to investigate the effect of the~     training program on physicians' knowledge of tobacco cessation, practice of performing~     cessation counselling, and attitudes toward tobacco control policies.~   "
41975|NCT02507570|"~     This is an open label study designed to examine the effects of Enzalutamide with concurrent~     administration of Radium Ra 223 dichloride in Castrate-Resistant (Hormone-Refractory)~     Prostate Cancer subjects with symptomatic bone metastases in both the pre- and~     post-chemotherapy setting.~   "
42073|NCT02506491|"~     This study is based on assess and contrast isometric and isokinetic core strength, static~     and dynamic balance, the number of falls, and functional autonomy in three different old~     women groups after a 22 weeks 1) Pilates-based structured exercise program, 2) muscular~     structured exercise program, and 3) nonexercising.~   "
41898|NCT02508584|"~     M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma~     hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency~     Investigational New Drug (eIND) 114686 following many prior treatments with standard~     antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The~     antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been~     shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma~     isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the~     setting of immune deficiency, and in some cases resulted in cures. The investigators propose~     to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB~     Biotherapeutics), purify human antibody after vaccination, test the purified antibody in~     killing assays to confirm potency, and then administer the purified human IgG to M. A. after~     FDA compassionate use IND application and local Institutional Review Board (IRB) approval.~   "
41899|NCT02508571|"~     This is randomized controlled trial investigating the effects of direct swallowing training~     and oral sensorimotor stimulation in preterm infants on oral feeding performance.~   "
41900|NCT02508558|"~     Previous studies have neglected two important aspects for the China National Space~     Administration. First, while biomechanical models are very sensitive to the characteristics~     of the subjects, data have been collected on subjects with biomechanical characteristics~     very different from those of typical Chinese astronauts. Second, pure video analysis~     techniques and kinematic data lack the necessary acceleration information important to~     understanding the forces exerted during movement and control of human motion. While some~     studies used force and moment sensors to aid in robot torque control and human joint work~     estimation, investigators are unaware of any studies performed in a microgravity environment~     that have combined the kinetic force and moment information with acceleration measurements~     to enable more reliable motion tracking without the need for acceleration estimation.~      This is why MICR0-G sensors and accompanying kinematic video system have been developed in~     order to provide for detailed analyses of the astronaut movement control strategy (joint~     forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques~     permits us to calculate the joint and musculoskeletal dynamics required to execute the~     microgravity motions, as well to provide insight into the altered movement strategies in~     reduced gravity as compared to 1-G locomotion.~   "
41901|NCT02508545|"~     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be~     created long enough for safely testing changes in human perception and behavior. In addition~     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present~     another unique opportunity to test the same responses to hypergravity and back to 1G.~      Cognitive function, together with good oculomotor control, eye-hand coordination, and~     spatial orientation perception, is a critical subsystem that is used by the CNS in the~     control of vehicles and other complex systems in a high-level integrative function. Evidence~     from space flight research demonstrates that the function of each of these subsystems is~     altered by the transitions in gravito-inertial force levels. These neuro-vestibular~     alterations, unfortunately, correspond to mission phases where physical and cognitive~     performance are particularly critical for crew safety and mission success. To date, there is~     only limited operational evidence that these alterations cause functional impacts on~     mission-critical vehicle (or complex system) control capabilities. However, the true~     operational risks will be estimable only after the investigators have filled the knowledge~     gaps and when the investigators can accurately assess integrated performance in off-nominal~     operational settings.~      Accurate perception of self-in-space motion and self-motion relative to other objects are~     critical to piloting, driving, and remote manipulator operations. Immediately after space~     flight, most crewmembers have reported some degree of disorientation/perceptual illusion,~     often accompanied by nausea (or other symptoms of motion sickness), and frequently~     manifested by lack of coordination, particularly during locomotion. Despite recent,~     intensive training, some Shuttle landings were outside of the desired performance~     boundaries. Scores indicating neurovestibular dysfunction in returning astronauts generally~     correlated with poorer flying performances, including a lower approach and landing shorter,~     faster, and harder. An underestimation of distance, coupled to an overestimation of tilt~     magnitude or misperception of the type of motion, could be at the origin of these poorer~     performances.~      This study should confirm that the unloading of the otoliths in weightlessness induces an~     alteration in the egocentric reference during space flight. Errors in egocentric~     localization might contribute at a higher level to the computation of misleading~     world-centered representations, and therefore be partly responsible for illusory sensations~     and motion sickness symptoms during space flight, and postural instability and oscillopsia~     after returning in a reduced or terrestrial gravitational force level.~      Beside their fundamental implications, the results of this study have also practical~     implications in the design of man-machine interfaces. Changes in judgment of distance in~     microgravity or in reduced gravity affect crew posture and reach, display orientation, and~     other visual cues, which should be considered in hardware and operations design.~   "
41902|NCT02508532|"~     This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to~     evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and~     preliminary antineoplastic activity of BLU-285, administered orally (PO), in adult patients~     with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2~     parts, a dose-escalation part (Part 1) and an expansion part (Part 2).~   "
41903|NCT02508519|"~     The aim of the study is to investigate how effective is zonal acupuncture method compared to~     balance method to obtain a short coming pain relief effect, which takes place several~     minutes after needle insertion.~   "
41904|NCT02508506|"~     This study will evaluate the effect of various degrees of renal function on the~     pharmacokinetics and safety of ALKS 5461.~   "
41905|NCT02508493|"~     Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young~     adults (i.e., 18-65 years) with MDD. It has also been shown that among adults with MDD who~     are gainfully employed, measures of cognition are a greater determinant of overall workplace~     performance than is total depression symptom severity. Several lines of evidence indicate~     that cognitive deficits that persist between episodes of depression are critical~     determinants of functional recovery in the workplace. The functional implications associated~     with cognitive impairment provide the impetus for systematic evaluation, measurement and~     assessment of the domains of cognition expected to be impaired in this patient population.~      To date, no measurement tool has been sufficiently validated and/or determined to be~     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of~     available comprehensive psychometric tools include relative lack of availability, cost, lack~     of access to most healthcare providers, and above all else, the lengthy time to administer.~     Moreover, the need for a psychometrist to interpret the results adds to the complexity and~     the costliness of such an endeavor.~      It is imperative that any tool recommended for clinical utility be aligned with the busy~     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the~     presence of cognitive dysfunction in MDD in the clinical environment should include, but not~     be limited to, features such as good conceptual coverage of cognitive domains affected in~     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture~     effects and practice effects. The tool would also need to be brief, easy to administer and~     interpret, and complement busy clinical practice.~      This study is designed to validate a brief user-friendly tool capable of detecting deficit~     in cognitive performance among adults with MDD. Data will be gathered with the aim to~     determine whether the proposed tool identifies cognitive deficits in adults with MDD and~     differentiates the clinical MDD population from healthy controls.~      It is anticipated that the THINC-it tool will be free of charge and downloadable from the~     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will~     be accessible via computers/tablets, will take 20 minutes to self-administer in a clinical~     setting, and the performance results will be immediately available.~   "
41906|NCT02508480|"~     We are conducting a randomized clinical trial (RCT) comparing the 10-week peer-led~     Photovoice program to services as usual (SAU) at a large publicly funded community mental~     health agency in Massachusetts. The control SAU condition will be enhanced with a 60-minute~     peer-led group educational session about understanding and coping with prejudice and~     discrimination. The 10-session, peer-led Photovoice program, designed to empower individuals~     with serious mental illness (SMI) to confront public prejudice and discrimination and reduce~     personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our~     Center, with primary contributions from staff with a lived experience of mental illness.~     Development of the Photovoice program was guided by an adaptation of the stress-coping~     model, informed by recent research and conceptualizations of the effects of stigma on people~     with SMI. The stress-coping model explicates the mechanisms by which public stigma about~     mental illness can lead to personal stigma, which in turn has a negative impact on the~     person's mental health and psychosocial functioning. This model also identifies critical~     factors that contribute to personal stigma or protect against it, as well as more vs. less~     adaptive coping responses, that are the primary focus of the Photovoice program.~   "
41907|NCT02508467|"~     This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic~     activity of BLU- 554 administered orally in patients with hepatocellular carcinoma (HCC).~     The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part~     2).~   "
42084|NCT02506257|"~     Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study~     to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic~     solution compared to placebo in healthy subjects~   "
41908|NCT02508454|"~     The Miami Heart Study at Baptist Health will be an observational, longitudinal and~     prospective cohort study in a target population of 4000 healthy subjects (40-65 years old)~     consisting of members from the Greater Miami Area (including eligible BHSF(Baptist Health~     South Florida) employees). Baseline examination will consist of (1) assessment for~     cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening~     for subclinical atherosclerosis using Coronary CT angiogram, Coronary Artery Calcium (CAC)~     testing, vascular 2D/3D ultrasound, endothelial function, arterial stiffness and (3) blood~     sampling for determination of traditional risk factors, advanced omics and biobanking.~     Participants will be followed yearly via telephone, email, or mail for change in health~     status with a focus on cardiovascular disease events, including acute myocardial infarction~     and other forms of coronary heart disease (CHD), stroke, and congestive heart failure;~     mortality; and for cardiovascular disease interventions.~      The Miami Heart Study at Baptist Health is expected to identify new imaging and biological~     factors associated with the presence and feature of earliest markers of subclinical~     atherosclerotic disease and provide opportunities for discovery/validation of novel~     biomarkers to identify these high-risk features. This is expected to lead to advances in~     understanding of evolution and progression of atherosclerotic cardiovascular disease starts~     with an ultimate goal of establishing more personalized, evidence-based approach to medical~     care.~   "
41909|NCT02508441|"~     This is a first-in-human, open-label, dose escalation and expansion, 2-part study to~     determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection~     in patients with advanced unresectable solid tumors that are refractory to standard therapy~     or for which no standard therapy is available.~   "
41910|NCT02508428|"~     The purpose of the study is to determine whether crosslinked Marathon and standard Enduron~     polyethylene liners show differences in survivorship due to wear-related revisions at~     minimum 14-year follow-up and every 5 years after.~   "
41911|NCT02508415|"~     Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first~     Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a~     marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively.~      Periodontal disease is a chronic inflammatory disease which results in gingival~     inflammation, irreversible attachment loss, alveolar bone destruction and eventually tooth~     loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%.~     Periodontal disease, through inflammation and destruction of the periodontium produces~     clinical signs and symptoms, some of which may have a considerable impact on quality of life~     (QoL).~      A positive association between obesity and periodontal disease was repeatedly demonstrated~     worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to~     normal weight individuals. These cytokines decrease after weight loss. Adipokines produced~     by adipose tissue could be one of the mechanisms mediating the association between obesity~     and periodontal disease. This suggests that obesity may have the potential to modify the~     host's immunity and inflammatory system.~      This project will extend the existing information on the association between obesity and~     periodontal disease including QoL aspect to a Malaysia population. It will also improve~     knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease~     relationship. By extension, this study also will cast light on the effects of periodontal~     interventions for the subgroup population.~   "
41912|NCT02508402|"~     ABSTRACT:~      Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish~     whether dexamethasone plays a role in shorting the duration interval between initiation of~     labor induction and beginning of the active phase in primigravida full-term pregnancy.~      Methods: case control study included 86 primigravidae with full term pregnancy classified~     into two groups: The participant of Group I will receive a prefilled syringe with two~     milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not~     receive Dexamethasone or any other cervical ripening agent.~      Key Words: Dexamethasone;post-term pregnancy;induction of labor.~   "
41913|NCT02508389|"~     The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered~     prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and~     severity of radiation induced oral mucositis in patients who have been diagnosed with~     locally advanced, non-metastatic squamous cell carcinoma of the head and neck.~   "
41914|NCT02508376|"~     This is a phase I randomized, double blind clinical trial designed to evaluate the safety,~     tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated~     with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will~     receive a total of 3 doses administered intramuscularly on Days 1, 29 and 57. Subjects will~     be monitored for approximately 422 days (365 days following the third study injection),~     including safety laboratory analyses done just prior to and 7 days following each study~     injection. Blood samples will be obtained for immunological assays (Luminex, intracellular~     cytokine staining at Days 1 and 71, and antibody analysis at Days 1 and 85). The primary~     objective is to evaluate the safety and tolerability of 10 µg ID93 + 5 or 10 µg AP10-602~     compared to 10 µg ID93 + 5 µg GLA-SE and 10 µg ID93 alone following three consecutive~     intramuscular injections administered on Days 1, 29 and 57.~   "
41915|NCT02508363|"~     The investigators are testing different ways of following up with drivers who attend our~     health fairs to find the best way to make sure that taxi drivers go to important medical~     appointments and have a regular doctor to help with their health problems.~   "
41916|NCT02508350|"~     The first objective of this study was to characterize the pharmacokinetics and~     pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the~     second objective is to identify the optimal dosing scheme for daptomycin among patients with~     septic shock and to enhance therapeutic outcomes.~   "
41917|NCT02508337|"~     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)~     compared to vehicle in the treatment of subjects with inflammation and pain following~     cataract surgery.~   "
42011|NCT02507310|"~     Based on preliminary data and previous studies, we hypothesize that the ambient temperature~     experienced by an individual influences his or her food intake. Specifically, exposure to~     temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in~     a sedentary situation. Researchers will execute a crossover randomized control trial~     specifically testing thermal exposure and its effect on individual female's food~     consumption.~   "
41918|NCT02508324|"~     The purpose of this study is to determine the overall safety of adoptive immunotherapy when~     given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of~     cells from a donor to help fight cancer. The donor cells will be either from the umbilical~     cord blood of a newborn baby or they will be cells collected from a relative~     (haplo-identical cells).~      The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or~     haplo-identical stem cells - will be analyzed separately.~      Preliminary data from other centers has suggested that adoptive immunotherapy with cells~     from a relative is an effective approach that may improve remission rates and survival in~     AML and MDS, because they exert anti-cancer effects of their own (so called graft vs~     leukemia effects) and possibly because they hasten recovery of cell counts from~     chemotherapy. The Investigators are interested in confirming these data, but also in testing~     umbilical cord blood cells for the same purpose. Preliminary data indicate that umbilical~     cord blood cells may have more powerful graft vs leukemia effects and cause fewer~     side-effects.~   "
41919|NCT02508311|"~     Spinal cord injury (SCI), especially involving the cervical and upper thoracic segments, can~     significantly compromise respiratory muscle function. Respiratory complications can ensue,~     including lung collapse and pneumonia, which are the primary cause for mortality in~     association with traumatic SCI both during the acute and chronic phases post-injury. Lesions~     at the level of the cervical or high thoracic spinal cord result in respiratory muscle~     weakness, which is associated with ineffective cough, mucus retention, and mucus plugging.~     Despite the fact that pulmonary complications are a major cause of morbidity and mortality~     in this population, there is a paucity of effective interventions in the SCI population~     known to improve respiratory muscle strength with pharmacologic interventions receiving~     little to no attention. The current objective of this study is to determine the~     effectiveness of 16 weeks of sustained release oral Albuterol to; (1) improve respiratory~     muscular strength, and (2) improve cough effectiveness.~   "
41920|NCT02508298|"~     This is a prospective longitudinal study that will evaluate if changes (pre and post~     therapy) in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen~     stiffness (SS) as measured by acoustic radiofrequency impulse (ARFI) correlate with changes~     in portal pressure as determined by the hepatic vein pressure gradient (HVPG) in patients~     with compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.~   "
41921|NCT02508272|"~     Discovery of differences in the host response in patients with systemic inflammation and~     sepsis, and identification of novel, specific markers by using a longitudinal~     clinico-transcriptomic approach.~   "
41922|NCT02508259|"~     This study is designed to test the safety and efficacy of a single, intravenous dose of~     suramin in autism spectrum disorders (ASD).~   "
41923|NCT02508246|"~     This phase I trial studies the side effects and the best dose of WEE1 inhibitor MK-1775 when~     given together with docetaxel and cisplatin in treating patients with stage III-IVB squamous~     cell carcinoma of the head and neck that may or may not be able to be removed by surgery~     (borderline resectable). WEE1 inhibitor MK-1775 may block the growth of tumor cells by~     blocking some of enzymes that are needed for tumor growth and may also help docetaxel and~     cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in~     chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving WEE1 inhibitor MK-1775 with docetaxel and cisplatin before~     surgery may kill more tumor cells and shrink the tumor, allowing patients to undergo surgery~     to remove it.~   "
41924|NCT02508233|"~     Many recent randomised multi-centre trials have used the AOS and the involvement of the~     French-speaking population is limited by the absence of a French version. The goal of our~     study was to develop a French version and validate the psychometric properties to assure~     equivalence to the English original.~   "
41925|NCT02508220|"~     The study compares the short-term tinnitus reduction following a single oxytocin~     intervention with a placebo control condition.~   "
41926|NCT02508207|"~     To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661~     in combination with ivacaftor (IVA) (VX-661/IVA) in subjects with cystic fibrosis (CF) who~     are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR)~     gene.~   "
41927|NCT02508194|"~     This study will be the first assessment of the efficacy of MEDI7510 for the prevention of~     RSV disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in~     the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of~     MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It~     will also expand the safety database of subjects dosed with MEDI7510. The study will also~     assess the immune response to MEDI7510 in Season 1 and Season 2.~   "
41928|NCT02508181|"~     The investigators enrolled pediatric patients who are undergoing strabismus surgery. The~     investigators insert either an I-gel or laryngeal mask airway Supreme and measure the~     intraocular pressures.~   "
41929|NCT02508168|"~     The purpose of this study is to determine the relative bioavailability of alogliptin 12.5~     milligram (mg) and immediate-release metformin 1000 mg when administered as individual~     tablets and as a fixed-dose combination (FDC) product.~   "
41930|NCT02508155|"~     The purpose of this study is to assess the safety, drug levels and effects on the body of~     MEDI7352, in subjects with painful osteoarthritis of the knee.~   "
41931|NCT02508142|"~     This study aims to assess the analgesic efficacy and safety of intravenous 20 mg~     Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with~     acute gastroenteritis in the emergency department.~   "
41932|NCT02508129|"~     Insomnia and hypertension are common health problems that often occur together and influence~     each other. This practical, low-cost, clinical trial will evaluate two behavioral treatments~     for insomnia (a brief intervention with therapist contact and a self-guided Internet~     intervention) compared to usual care. Participants will be recruited using the electronic~     health record in their primary care physicians' offices, and will be evaluated for sleep,~     blood pressure, and health outcomes after 9 weeks, 6 months, and 12 months.~   "
42095|NCT02506101|"~     The objective of this study is to assess the effectiveness and safety of~     narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.~   "
41934|NCT02508103|"~     This research study will look at differences among women with severe premenstrual mood~     symptoms. One goal of this study is to look at how the brains of two groups of these women~     respond to emotional information. The two groups are women who were abused early in life and~     women who were not. The study will use a brain scan to look at how certain areas of the~     brain respond to the viewing of words and pictures. Another goal of this study is to look at~     the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on~     those same brain areas during the viewing of words and pictures. Also, the investigators~     will look at whether oxytocin given in the nose improves premenstrual mood symptoms.~   "
41935|NCT02508090|"~     Genotype 1 CHC participants from Study SPC3649-207 with null response to prior~     pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension~     study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen~     monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as~     an investigational product.~   "
41936|NCT02508077|"~     This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan~     hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal~     cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF)~     wild-type genes, has spread from the original site of growth to another part of the body~     (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus~     irinotecan hydrochloride-based therapy, and who have failed at least one subsequent~     non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in~     chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     panitumumab, may block tumor growth in different ways by targeting certain cells. Giving~     FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.~   "
41937|NCT02508064|"~     This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from~     prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype~     extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg~     extended release tablet of BMS-663068.~   "
41938|NCT02508051|"~     Optimal patient care hinges on physicians remaining up to date with developing medical~     knowledge. With ever increasing clinical demands however, the ability of physicians to do~     this is compromised. While the structure of journal based reports requires the devotion of~     significant time to glean emerging medical findings, social media can grab an individual's~     attention and then direct them to external media sites, so as to obtain more specific and~     detailed information of emerging medical findings. If medical journals were to fully embrace~     social media, physicians would have a more time-cost effective means for staying up to date.~      Specific aims Using the investigator's experience as editors of two medical education based~     blogs, the Specific Aims of this project is to determine if a combined journal and social~     media-based education strategy will be more likely to continuously engage physicians. The~     investigators will specifically test whether physicians who access a medical journal blog~     will have better knowledge of the information contained in a journal, measured by CME-based~     questions of journal articles than they would if they only received links to the journal's~     site.~      Specifically, the investigators will randomize participants into 3 groups with all~     interventions done by e-mail: group 1 is the usual care group, and will receive no~     intervention except for a reminder every six months to take a test of journal-based~     Continuing Medical Education (CME) questions from 2 anesthesiology journals; group 2 will~     get e-mailed web links to different specific articles, including articles on which the CME~     questions are based, published in 2 anesthesiology journals Monday through Friday with a~     reminder to take the same test every six months; and group 3 will get e-mailed web links to~     blogs Monday through Friday based on the same specific articles as in group 2; each daily~     blog will focus on a specific article, including articles on which CME questions are based,~     the blogs will have web links to the articles on which they are based and every six months~     group 3 will get a reminder to take the same test. This will continue for 2 years' duration.~     Every six months, the investigators will assess knowledge of material contained in the two~     journals using CME material from the journals.~      The investigators hypothesize that those participants randomized to group 3, the group that~     will receive web links to blogs, will stay more informed, as measured by the test score of~     CME-based questions. The investigators expect that both groups 1, usual care, and 2,~     e-mailed links to articles, will have a similar low score as the investigators found in a~     preliminary study of anesthesiologists who were presented with a set of journal-based CME~     questions.~      Public Health Significance. This study will demonstrate the utility of journal based blogs~     as a support to physicians in their effort to remain up to date with developing medical~     knowledge.~   "
41939|NCT02508038|"~     This phase I trial studies the safety of transplantation with a haploidentical donor~     peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction~     with the immunomodulating drug, Zoledronate, given in the post-transplant period to treat~     pediatric patients with relapsed or refractory hematologic malignancies or high risk solid~     tumors.~   "
41940|NCT02508025|"~     Purposes of this research:~        -  To study similarities and differences in FCE performances between participants from~          different countries, jurisdictions, and evaluators.~        -  To study determinants of FCE performance.~   "
41941|NCT02508012|"~     Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors~     have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD).~     However, more than one-third of patients present primary resistance, and one more third~     become resistant over time. One of the main factors associated with loss of response is the~     immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the~     TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from~     the serum and decrease its therapeutic activity. In this study the investigators propose a~     medico-economic evaluation of the mesurement of anti-TNF agents and anti-drug antibodies~     serum concentrations in the management of patients with inflammatory bowel disease treated~     with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis~     (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring.~     In the monitored group, in case of loss of response, the clinician will use biological~     informations to adapt the treatment following a simple treatment algorithm. In the~     unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician.~     Clinical and economical benefits of the biological monitoring will be evaluated after a~     follow-up period of two years.~   "
41942|NCT02507999|"~     Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output~     monitoring (NICOM) device to guide management of circulating blood volume and blood pressure~     during procedures. The purpose of this study is to determine whether the use of~     goal-directed therapy to optimize blood volume and cardiac output during the procedure can~     improve the outcome of patients undergoing endovascular treatment of a brain aneurysm.~   "
41943|NCT02507986|"~     The main objective of this study is to compare the incidence of detected atrial fibrillation~     (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of~     detected AF by a 7-Day Holter ECG.~   "
42096|NCT02506088|"~     The present research creates a partnership between researchers and a community agency to~     evaluate whether a sexual assault prevention program for high school students reduces~     perpetration of sexual violence among high school boys.~   "
41947|NCT02507934|"~     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms~     of discomfort, visual disturbance, and tear film instability with potential damage to the~     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation~     of the ocular surface.~      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted~     product of cells that line the joint tissues, which is present at the surface of articular~     cartilage and it has been investigated on its roles at the ocular surface, in normal and~     pathologic conditions such as dry eye.~      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin~     eye drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops~     solution in subjects with moderate dry eye.~   "
41948|NCT02507921|"~     The investigators aim to assess type and frequency of HIV drug resistance in adults~     presenting to the Infectious Diseases Institute (IDI) in Kampala, Uganda, and compare this~     data to patients from the Swiss HIV Cohort Study (SHCS). This study is a single-site,~     cross-sectional study. The Investigators' goal is to perform viral load measurements in 2750~     HIV-infected patients who have been on ART for 6 months or more. Presuming a detectable~     viral load in 10%, resistance testing would then be performed in 250 patients on ART. All~     adult patients attending will be screened for enrollment. Furthermore, the investigators'~     goal is to perform resistance testing in 250 ART naive patients in order to detect~     transmitted resistance mutations. Investigators will therefore consecutively screen and~     enroll 250 ART naive patients who attend the clinic during the study period. For each~     participant, a case report form (CRF) form will be completed which includes social, as well~     as medical information. Investigators will ask each participant for permission to store~     plasma in case resistance testing must be repeated, and serum, in case of future research~     questions.~   "
41949|NCT02507908|"~     The objective of this observational laboratory study is to measure the correlation between~     5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine~     collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and~     urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and~     analysed.~   "
41950|NCT02507895|"~     Currently the process for stroke recovery is slow with majority of its treatments focused~     around physical therapy. Among the many methods employed to facilitate recovery in stroke,~     the use of motor imagery (MI) training may be beneficial towards stroke rehabilitation.~      In the current study, we propose 2 aims. Our first aim is to determine the feasibility and~     efficacy of a novel brain-computer interface-assisted MI train program (BCI-MI) in patients~     with chronic ischemic stroke. This is designed as a proof-of-concept study that only require~     a single-session trial. If patients successfully activate the BCI-MI system without much~     difficulty, our second aim is to enroll patients into a 4-week training program using the~     BCI-MI. Both functional magnetic resonance imaging (fMRI) and transcranial magnetic~     stimulation (TMS) will be done to determine the effects of the 4-week training program.~     Subjects may potentially see improvements in walking gait as preliminary data from previous~     studies have demonstrated positive results.~   "
41951|NCT02507882|"~     Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide as well~     as in Egypt. Despite improvements in HCC therapy, the prognosis for HCC patients remains~     poor. Today molecular, genomic and epigenomic aberrations in tumors are being deeply~     investigated. Many biomarkers were associated to HCC onset, and they could be useful for~     clinicians, but all show some limitations and no one is so early to predict the HCC onset.~      It is estimated that 51.5% of HCC cases can be attributed to HCV infection. Moreover, there~     is a large occult reservoir of HCV caused chronic liver disease in approximately 9 % in the~     Egyptian with estimated 6 million HCV chronic infections and estimated 150 000 new~     infections per year. Among them, we have to mention the polymorphism of IL28B gene~     rs12979860 C/T. and rs 4803217. The IL-28B gene encodes interferon-lambda 3 (IFN-λ3), which~     belongs to the type III IFN family. IFN-λ interacts with a transmembrane receptor inducing a~     potent antiviral response. In experimental model of HCV type III IFN was able to inhibit~     viral replication. IL-28B polymorphisms are linked to the efficiency of the inflammatory~     process during HCV infection, and to the mechanisms that HCV adopts to escape by innate and~     adaptive immunity.~      During the last years, a number of studies have assessed the association between the IL-28B~     polymorphisms and risk of HCC and liver cirrhosis (LC) occurrence in various populations;~     however, results obtained are still inconclusive.~      Interestingly, some polymorphisms located at the 3' untranslated region (UTR) of IL28B, e.g.~     rs 4803217, seem to interfere with the binding of miRNA, to date recognized as important~     post-transcriptional regulators. In the last years miRNAs acquired a growing relevance as~     potential biomarkers for several diseases including cancer, and many researches are focusing~     on understanding their role in cancer.~      Thus the objectives of the current proposal are to determine through investigating a cohort~     of 405 patients, whether IL28B rs12979860 and rs4803217 polymorphisms are associated to the~     risk of HCC in chronic hepatitis C (CHC) patients and, above all, to identify their role as~     predictor marker of HCC in CHC, when associated to miRNAs modulation. Data obtained by our~     work could be helpful in HCC diagnosis, thus leading to the improvement of the patients~     prognosis. The proposed activities are going to be implemented through a partnership us as~     Egyptian Liver Research Institute and Hospital (ELRIAH)- Dakhlya- Egypt and Non- Egyptian~     Partners.~   "
41952|NCT02507869|"~     Despite awareness of the benefits of engaging in regular physical activity, at least 50% of~     adults in the US do not meet recommended guidelines for physical activity. One potential~     explanation for this lack of regular physical activity is that people often experience~     exercise as affectively unpleasant. Evidence suggests that the more positively people~     experience exercise (i.e., the better they feel while exercising), the more likely they are~     to engage in regular physical activity. This may be especially true for people in poor~     cardiorespiratory condition. In this randomized trial, investigators compared the effects of~     an affect-guided exercise prescription (intervention) to a heart rate-guided exercise~     prescription (control) on change in physical activity minutes among previously underactive~     adults. Investigators also tested whether the effect of the intervention was moderated by~     differences in cardiorespiratory fitness.~   "
41976|NCT02507557|"~     Excessive fluid loss is often reported in gastrointestinal surgical patients due to~     preoperative fasting and bowel preparations. Insufficient fluid infusion may cause~     hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even~     induce postoperative acute renal failure. The aim of this study is to compare the effects of~     Goal-directed fluid therapy (GDFT) strategy with that of the conventional fluid management~     on the morbidity and mortality of postoperative complications, length of postoperative~     hospital stay, and medical expense, so as to provide clinical evidences for optimized~     intraoperative fluid management for patients undergone gastrointestinal surgery.~   "
41977|NCT02507544|"~     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer~     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer~     cell lines. The objectives of this study are to determine the safety profile of TRX-818~     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD)~     and determine the recommended dose and regimen(s) to initiate Phase 2.~   "
41953|NCT02507856|"~     The multi-center, prospective PRODAST study is investigating patients with non-valvular~     atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack~     (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists~     of a baseline visit and a 3 months central follow-up for patients who were discharged with~     dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment~     at all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical~     practice will be collected to describe how dabigatran is prescribed and used in the~     population of AF patients with recent cerebrovascular events and how these factors influence~     important outcome and safety events. The utilization of dabigatran will be assessed with~     regards to treatment persistence, compliance, proportion of patients discontinuing treatment~     and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or~     systemic embolism. Due to the fact that patients will be treated according to local medical~     practice it is possible that medication will be changed during the observation period. In~     the follow-up, data from the first as well as from the second prescribed medication will be~     used in the study. To explore a long-term effect of anticoagulation, survival up to one year~     will be assessed.~   "
41954|NCT02507843|"~     This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic~     Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants~     will receive vitamin D supplementation, while the other half will receive placebo.~   "
41955|NCT02507830|"~     Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran~     2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The~     investigators aim is to recruit 150 patients for the study.~      The outcomes The investigators would like to determine are : postoperative pain,recurrences~     and complication rates such as seromas.~   "
41956|NCT02507817|"~     During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory~     factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF),~     neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated~     with neurogenesis and differentiation of brain cells.~      LIF is a cytokine that is essential for the development of the central nervous system, and~     has recently been shown in rats that maternal LIF stimulates placental ACTH~     (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC~     (nucleated red blood cell ), which in turn promotes brain development of the fetus In other~     studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during~     pregnancy influence the normal development of the brain and may cause brain damage by~     altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the~     cause of brain damage.~      Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the~     embryo's brain in one of two ways:~        1. Altering Placental ACTH~        2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm~          labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for~          neuroprotection, randomized controlled studies showed that if these women are treated~          in the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and~          other severe motor problems are decreased.~      The mechanism for this decrease is unknown and that is the purpose of our study.~      The purpose of our research is to examine maternal LIF levels prior to birth and Maternal~     and cord levels after delivery and to see if levels are different if the mother was treated~     with Magnesium Sulphate. We will also check the placental ACTH level~   "
41957|NCT02507804|"~     The aim of the study is to design and evaluate a PROMs diary for cancer patients to self~     report side effects and experiences of their treatment, and thereby create a detailed~     account of treatment related adverse events and their impact on daily activities to share~     with the care team.~   "
41958|NCT02507791|"~     This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to~     remotely track the physical activity of obese pediatric patients who are concurrently~     enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit~     devices and will be called weekly to review their average daily steps and heart rates.~     Patients will receive the Fitbit either at the beginning of classes or upon completion of~     classes. Patients will then be followed remotely and called weekly for 12 additional weeks~     after completing classes. The two groups will be compared to examine for differences.~   "
41959|NCT02507778|"~     The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung~     cancer.~   "
41960|NCT02507765|"~     This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and~     transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be~     removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to~     normal tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood~     vessels near the tumors and then blocking the blood flow to allow a higher concentration of~     the drug to reach the tumor for a longer period of time. SBRT may make TACE more beneficial~     by increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to~     enter the tumor. Giving SBRT with TACE may work better in treating patients with liver~     cancer that cannot be removed by surgery.~   "
41961|NCT02507752|"~     This multicenter prospective observational study will evaluate the quality of life in~     participants with rheumatoid arthritis (RA) who are initiated with rituximab~     (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.~   "
41962|NCT02507739|"~     Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women~     since ancient times in many countries. The advent of the epidural in the 60s revolutionized~     the management of pain during childbirth. The consideration of such advance is to keep the~     laboring parturients lying down. Indeed at this time the use of high doses of local~     anesthetics charge of an engine block against formally allocate all up.~      In a matchless analgesic efficacy during childbirth, epidurals also offers the possibility~     of a secure obstetrical gesture because without general anesthesia, inhalation great~     purveyor in these women with full stomach. These advantages explain the considerable growth~     in the number of epidurals performed in obstetric work in France over the last thirty years.~     However, this analgesia technique will soon be implicated in the alterations of obstetric~     mechanics, its effects depend primarily on the nature and concentration of the products~     used.~      Evolution is then marked by a considerable reduction of concentrations of local anesthetics~     used with the addition of opioids, allowing to achieve an isolated analgesia without~     impairing motor skills, it involves the lower limbs or muscles pelvis, allowing the woman to~     mobilize.~      Ambulatory epidural and made its appearance in the early 90. Responding to women in labor~     demand wishing to receive effective labor analgesia without being confined to bed, she then~     puts to the test the dogmas and practices on how to provide analgesia that is both effective~     and safe. It is now well codified and used daily in some maternity hospitals.~      The mobilization of women during labor is a subject that motivates obstetric teams Caen~     University Hospital for many years. Motherhood has thus given the means for monitoring and~     ambulatory epidural analgesia protocol suitable for this technique.~      The introduction of this daily care protocol opens new possibilities of care delivery hoped~     more physiological and less iatrogenic.~      A critical evaluation of the changes possibly recorded on obstetric mechanics inherent~     question, motivating, for which the answers are now few and discordant in the literature.~      The investigators therefore propose a randomized study evaluating single-center relative to~     obstetrical work typically occurring in a bed, the mobilizations of repercussions out of~     bed, in terms of obstetrical mechanics and comfort of the parturient.~      Those will be objectified by a significant change in the working hours. This study included~     560 patients is scheduled to last 2 years. Positive effects could also have repercussions in~     terms of public health and even of health economics.~   "
41964|NCT02507713|"~     Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.~     Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the~     electrophysiologic study.~      Objectives.~        1. To establish the diagnostic value of ultrasonography in ALS.~        2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients~          with ALS.~        3. To check the relationship between ultrasound, clinical variables and functional tests~          in patients with ALS.~      Methods. A longitudinal observational study in a consecutive sample of patients diagnosed~     with ALS will be realized. All the patients will be examined 3 times during 6 months and~     capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross~     sectional ultrasonography of several muscles and also median and tibial nerves will be~     performed. All the images will be processed and analyzed for obtaining morphometric~     variables (muscle thickness and nerve area) and textural ones (echogenic variation, entropy,~     homogeneity, textural contrast and correlation). Frequency of twitches will be also~     recorded. After longitudinal study, a survival study will be performed in relation to~     functional and sonographic variables.~   "
41965|NCT02507700|"~     Popliteal block is a technique for providing postoperative pain management in children. In~     this randomized double-blinded study, the investigators evaluated the effects of~     preoperative popliteal nerve block on postoperative pain and analgesic requirement in~     children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker~     faces scale and skin conductance fluctuations will be assessed.~   "
41966|NCT02507687|"~     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost~     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or~     ocular hypertension who are not adequately managed with topical IOP-lowering medication.~   "
41967|NCT02507674|"~     1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid~          acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will~          use a newly developed acquisition method and post-processing technique to create three~          dimensional image models of the abdomen.~        2. Study activities and population group. The study population will be a convenience~          sample of patients 18 years and younger with suspected appendicitis, whose clinical~          care (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study~          intervention includes acquisition of research ultrasound images, which will not be used~          for clinical care, and comparison of these images with clinically obtained images.~          Other clinical data such as surgical and pathology reports will also be reviewed. If~          not evident from the patient medical record, the final diagnosis will be confirmed by a~          telephone call to the subject 2 weeks after the initial visit.~        3. Data analysis and risk/safety issues. This is a pilot study intended to determine~          feasibility and to refine image reconstruction algorithms. Research images will be~          compared to clinical images to determine the frequency of visualization of the appendix~          and whether the appendix was deemed normal or abnormal. Comparison of research images~          with final diagnosis will also occur. The research intervention, an ultrasound exam,~          has no known safety risks. The only risk to subjects is loss of confidentiality.~      This study is observational, not interventional, because the experimental ultrasound will be~     performed in all subjects and will not be used in the clinical care of patients~     (consequently, will not have the opportunity to affect clinical outcomes). Experimental~     images will be reviewed after completion of clinical care and will not be provided to the~     clinicians caring for the subjects. We are not measuring the effect of the ultrasound~     examination on the subjects' outcomes.~   "
41968|NCT02507661|"~     The purpose of this study is to evaluate esthetic outcome of implant supported single crowns~     after alveolar ridge preservation with beta three calcium phosphate with collagen type I in~     aesthetic region in upper jaw.~   "
41969|NCT02507648|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine)~     and Tamiflu® 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences~     ,California ,USA after a single oral dose administration of each to healthy adults under~     fasting conditions.~   "
41970|NCT02507635|"~     The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and~     patients' quality of life and prevent the development of asthma. Therapeutic strategies also~     target a reduction of pro-inflammatory mediators released from activated cells, including~     mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may~     increase the risk of asthma occurrence, especially in patients with persistent allergic~     rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis,~     regardless of symptom severity or persistence. They control all of the symptoms, but to a~     lesser extent nasal congestion. New generation agents, such as levocetirizine and~     desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.~   "
41971|NCT02507622|"~     The main goal of the study is demonstrate that e-Nose system function is not altered in~     weightlessness and more specifically that gas concentration measurements are the same in~     weightlessness and normal gravity.~   "
41972|NCT02507609|"~     The purpose of the study is to determine the relationship between the degree of~     neuromuscular block, the release of cytokines and clinical outcomes in elderly patients~     undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade~     decreases the release of cytokine and the incidence of postoperative delirium in elderly~     patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.~   "
41973|NCT02507596|"~     A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in~     comparison with bone allograft and open flap debridement for management of periodontal~     intrabony defects.~   "
41974|NCT02507583|"~     This human Phase 1 trial is a continuation of a Phase 1 trial which enrolled patients with~     recurrent gliomas (#TJU-14379-101) and which was designed after a previously conducted Phase~     1 human trial at our institution. With certain modifications, it is intended to reproduce~     the safety results of the recurrent glioma previous trials as well as explore any objective~     clinical responses in newly diagnosed patients. Protocol 14379-101 is closed to accrual and~     Abbreviated Clinical Report is prepared for FDA submission. The safety profile for this~     protocol was quite favorable.~      This treatment involves taking the patient's own tumor cells at surgery, treating them with~     an investigational new drug (an antisense molecule) designed to shut down a targeted surface~     receptor protein, and re-implanting the cells, now encapsulated in small diffusion chambers~     the size of a nickel in the patient's abdomen within 24 hours after the surgery. Loss of the~     surface receptor causes the tumor cells to die in a process called apoptosis. As the tumor~     cells die, they release small particles called exosomes, each full of tumor antigens. The~     investigators believe that these exosomes as well as the presence of the antisense molecule~     work together to activate the immune system against the tumor as they slowly diffuse out of~     the chamber. Immune cells are immediately available for activation outside of the chamber~     because a wound was created to implant these tumor cells and a foreign body (the chamber) is~     present in the wound. In this trial, a dose escalation of the therapeutic agent will involve~     an increase in both biodiffusion chamber number as well as the time the biodiffusion~     chambers remain implanted. The wound and the chamber fortify the initial immune response~     which eventually leads to the activation of immune system T cells that attack and eliminate~     the tumor. By training the immune system to recognize the tumor, the patient is also~     protected through immune surveillance from later tumor growth should the tumor recur.~     Compared to treatment alternatives for tumor recurrence, including a boost of further~     radiation and more chemotherapy, this treatment represents potentially greater benefit with~     fewer risks.~   "
41978|NCT02506478|"~     ED patients who are able to drink juice will be approached and asked their beverage~     preference.~   "
41982|NCT02506426|"~     Chronic sinusitis is a disease involving severe swelling of your facial sinuses and nasal~     cavity. Chronic sinusitis is a common disorder and roughly 5% of adult men and women have~     chronic sinusitis in Canada. Surgery has shown to have benefits for people suffering from~     chronic sinusitis. There are two surgeries which have been shown to help people: 1)~     Endoscopic sinus surgery with septoplasty and 2) Septoplasty alone. Both surgeries have~     research which show they help improve quality of life and reduce symptoms. However, it is~     unknown which surgery is better.~      'Endoscopic sinus surgery with Septoplasty' uses special telescopes through the nostrils to~     make the nasal septum straight and open the facial sinuses without any incisions. The~     sinuses are opened using special microscopic instruments and the procedure takes~     approximately 90-120 minutes.~      'Septoplasty alone' is a shorter (take approximately 25-30 minutes) and less invasive (do~     not open the facial sinuses) that might provide the same benefits compared to the larger and~     longer endoscopic sinus surgery.~      Currently, performing 'Endoscopic Sinus Surgery and Septoplasty' together is the standard of~     care, however, there is limited evidence to support just performing 'Septoplasty alone'~     provides similar results but it is shorter and has lower risks. This represents a~     significant gap in the investigators' knowledge, which adversely impacts a doctor's ability~     to counsel patients who have chronic sinusitis and elect to undergo surgery.~      The purpose of this study is to understand which surgery (endoscopic sinus surgery plus~     septoplasty OR septoplasty alone) is the most appropriate for people with chronic sinusitis.~     You are being asked to participate in this study because you have chronic sinusitis and are~     also going to have surgery to improve your quality of life.~   "
41983|NCT02506413|"~     This study aims to adapt and implement a district-led, policy-based, low cost Maternal and~     Newborn Health (MNH) intervention package using the MamaToto process, proven successful in~     Uganda, in rural Tanzania. The investigators hypothesize that the 'MamaToto Package' will be~     successfully implemented in the Misungwi District and will be effective in improving key~     maternal and newborn health indicators of study participants.~   "
41984|NCT02505581|"~     Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be~     used.~      Experimental group: Patients undergoing elective colorectal surgery that involves, colonic~     resection.~      The antibiotic prophylaxis in this group will be composed of:~      An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg~     / 8h, 3 doses) the day before surgery.~      Control group: Patients undergoing elective colorectal surgery that involves, colonic~     resection.~      The antibiotic prophylaxis in this group will be composed of:~      An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic~     induction.~      In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the~     intraoperative time elongates more than three hours or there is an intraoperative bleeding~     over 1000cc.~      There won´t be a placebo treatment. Subject compliance will be evaluated according to the~     usual practice in surgical care field~   "
41985|NCT02505568|"~     The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by~     assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease~     (DAIBD) score of 20 or more in participants with active intestinal Behcet's disease who are~     refractory to conventional therapies.~   "
41986|NCT02505555|"~     The purpose of this study is to summarize our experience with and to evaluate the~     feasibility of transvaginal four-dimensional hysterosalpingo-contrast sonography using~     SonoVue (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility~     clinic are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of~     who undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are~     compared. All of the patients will be followed up. The complications of 4D-HyCoSy will be~     evaluated and the pregnancy outcomes will be recorded.~   "
41987|NCT02505542|"~     Patients receive study drug for one year (Part A). If, after the initial run-in phase, a~     sustained remission is reached they will be randomly split into one of three dose groups for~     another year (Part B). The maintenance of the sustained remission will be analyzed.~   "
41988|NCT02505529|"~     The UNCODE Study seeks to better identify the neurological causes of muscle weakness~     associated with advancing age. The main study consists of 4 laboratory-based testing~     sessions that involve testing muscle strength and physical and cognitive function as well as~     a battery of tests to 1) quantify brain excitability (using non-invasive transcranial~     magnetic stimulation), 2) modulate brain excitability (using non-invasive transcranial~     direct current stimulation), 3) spinal motor nerve firing characteristics, and 4) brain~     structure and function characteristics based on magnetic resonance images of the brain.~     Additionally, three option sub-studies are also available for enrollment. The first is a~     genetics sub-study where a cheek swab will be used to examine associations between certain~     genes and the physiological and functional measures obtained from the main study. The other~     two sub-studies are interventions. The first sub-study is a progressive resistance exercise~     training study where study participants will undergo 12-weeks of exercise training (3x/wk)~     and at the completion of the exercise training the measures obtained in the main study will~     be re-assessed. The other sub-study is a mental imagery sub-study where subjects are~     randomly assigned to perform a mental imagery training program consisting of imaging strong~     muscle contractions and mobility tasks (5x/wk) or to serve as a control (i.e., to not modify~     lifestyle) for 6-weeks. At the completion of the respective intervention period the measures~     obtained in the main study will be re-assessed.~   "
41989|NCT02505516|"~     patients om metformin from diabetic clinic were checked for bladder cancer~   "
42012|NCT02507297|"~     The goal of this study is to understand the contribution of sleep-disordered breathing (SDB)~     to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression.~     The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on~     sleep and depression symptoms in perinatal women. Participants will be pregnant women with~     depression and sleep-disordered breathing. Participants will be randomly assigned to receive~     either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and~     sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly~     thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at~     baseline and again 8 weeks later.~   "
42013|NCT02507284|"~     This study evaluates the tolerability, safety and activity of SRX246 in the treatment of~     irritability in patients with Huntington's disease. Two-thirds of all participants will~     receive SRX246, while the other third will receive a placebo.~   "
41990|NCT02505503|"~     Some people experience a cramp-like leg pain during walking that is relieved only by rest.~     This is called intermittent claudication (IC) and it is a common symptom of peripheral~     arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of~     life.~      The intensity of IC pain experienced during walking depends on several factors, including~     the type of footwear worn. For example, non-supportive shoes may make the calf muscles work~     harder during walking, leading to earlier and more-severe symptoms of IC.~      A member of the research team has developed a shoe that reduces the work done by the~     lower-leg muscles during walking. Preliminary data indicate that, when wearing these~     unloading shoes, people with IC were able to walk further without pain as compared with~     when wearing a normal pair of shoes. The current project aims to provide further information~     on the usefulness and acceptability of these shoes.~      Forty people with IC will complete a set of three walking tests on two separate occasions;~     once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The~     participants will then be given a pair of unloading or normal shoes to wear for two weeks,~     after which we will collect information on how acceptable the shoes were to wear via a~     survey of all participants and one-to-one interviews with a subset of participants.~   "
41991|NCT02505490|"~     The purpose of the study is to investigate the effect of television viewing on liking of~     food.~   "
41992|NCT02505477|"~     The purpose of this study is to attempt to treat cognitive and negative symptoms of~     schizophrenia, with the nutritional supplement N-acetylcysteine (NAC).~      Schizophrenia is a chronic mental disorder that affects approximately 65 million people~     worldwide, and causes significant disability and suffering. Patients with schizophrenia~     often hear voices and have persecutory delusions. Though these are the most recognizable~     features of the illness, the deficits most closely linked to disability are known as~     cognitive deficits and negative symptoms. Cognitive abilities refer to the ability to~     perform mental tasks that require focus and attention, and also include memory and verbal~     skills. Negative symptoms refer to a lack of interest in the world, and decreased social~     interactions. In our study, the investigators aim to improve these symptoms and deficits by~     targeting the glutamate system.~      Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is~     abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at~     others. As well, free radicals surrounding glutamate receptors also interfere with their~     proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement~     that may restore glutamate to its correct levels in the brain, and may also help protect the~     brain from antioxidant damage.~      In our study, patients with schizophrenia will be randomly assigned to receive either NAC or~     placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione,~     will be measured before and after treatment, using a neuroimaging technique known as~     magnetic resonance spectroscopy. Cognitive and negative symptoms will also be assessed~     before, during and after treatment. The investigators hypothesize that glutamate and~     glutathione will be normalized in patients' brains, and that their negative and cognitive~     symptoms will be improved, too.~   "
41993|NCT02505464|"~     The focus of this research is to create a repository of ultrasonographic images and their~     corresponding medical data from pregnant women (the mothers of the fetuses that are imaged),~     focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One~     Health and the Le Bonheur Fetal Center.~   "
41994|NCT02505451|"~     Summary.~      Theoretical Rationale:~      The left ventricular myocardial performance results from a complex interplay between linear~     deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These~     components of myocardial mechanics can be assessed, at rest and during stress conditions, by~     high resolution echocardiography using the 2D-strain technology and constitute good~     indexes of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM)~     and metabolic syndrome (MS) are associated with an increased risk for cardiac diseases.~     While several clinical studies have reported, particularly in T2DM, a diastolic dysfunction~     (concept of diabetic cardiomyopathy), the existence of impaired regional myocardial~     function, with altered intrinsic contractility properties, remains largely unanswered,~     especially in the SM. Stress echocardiography is very interesting to reveal myocardial~     dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study~     is, however, today available on the kinetics of linear strains and twist/untwist dynamics in~     response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of~     production of important pro-inflammatory cytokines that have the potential, through an~     exacerbation of oxidative stress, to impair coronary endothelial function, increase~     fibrosis, but also directly affect cardiomyocyte calcium homeostasis. An increase in~     epicardial adipose tissue is consensually reported in T2DM and SM and is clearly associated~     with coronary atherosclerosis. A link between cardiac adiposity and overall cardiac~     function, particularly diastolic, is now suggested but to our knowledge no study has~     challenged its association with myocardial dysfunction in T2DM as SM patients.~      Objectives and Methodology: - To investigate regional myocardial linear deformations and~     torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM~     patients without clinical complications, - to study the links between expected regional~     myocardial abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control~     group of healthy individuals matched for sex and age will also be included.~      All the subjects will benefit from a clinical, anthropometric and biological evaluation. In~     addition, conventional echocardiography (remodelling and global diastolic and systolic~     functions) complemented by a functional analysis by tissue Doppler imaging will be~     performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber~     views for the objective assessment of myocardial longitudinal deformations as well as in the~     parasternal short axis (base and apex) for the evaluation of the circumferential~     deformations and basal and apical rotations and left ventricular torsion, at rest and under~     low dose of dobutamine (110 and 120 bpm).~   "
41995|NCT02507518|"~     Non small cell lung cancer is the first cause of cancer related death in France and is~     becoming an increasing health problem in developing countries.~      Recently for patient with no progression disease after first line chemotherapy, new~     therapies were validated in maintenance (bevacizumab) or switch maintenance treatment~     (erlotinib, pemetrexed) with improved survival.~      Until now, determination of efficiency of treatment is only based on morphological response~     (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical~     lesion modification.~      Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a~     biologically relevant tool for assessment of tumour response therapies.~      The assumption of the study is that FDG PET would allow to earlier detect a lack of~     response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is~     maintained up to evidence of progression disease.~      However, despite the increasing use of FDG PET for predicting therapeutic response, there~     are no validated criteria for judging response of maintenance therapy in non-small cell lung~     cancer.~      It seems necessary to determine standardized criteria response, earlier during the course of~     maintenance therapy in patient with non small cell lung cancer.~      The final aim is to optimize survival by an adapted metabolic imaging guided therapy.~   "
41996|NCT02507505|"~     The purpose of this study is to find out if two types of standard care anesthesia are the~     same or if one is better for people who have hip fractures.~   "
41997|NCT02507492|"~     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)~     injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare~     genetic mutations, on body weight, metabolic function and blood pressure. Patients who~     respond during the initial 84 days of treatment can enter into long-term (2-year)~     extensions. The study drug (RM-493) will be administered in an unblinded fashion.~   "
41998|NCT02507479|"~     The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to~     busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving~     disease eradication in patients with lymphoid malignancies not eligible for standard~     transplantation.~   "
42000|NCT02507453|"~     Parabolic flight is the only ground-based condition in which free-fall (0G) can be created~     long enough for safely testing changes in human perception and behavior. In addition to the~     0G period, parabolic flight generates equal duration periods of 1.8G, which present another~     unique opportunity to test the same responses to hypergravity and back to 1G.~      It is well known that performance decrements occur in astronauts during and after gravity~     level transitions. Illusions are commonly felt in orbit as well disorientation and~     perceptual limitations, mainly due to both psycho-physiological changes and adaptation and~     lack of familiar points of reference in the space environment. Studies performed during~     previous space missions showed several changes occurring in different gravity conditions,~     pointing out, for example, that colors and shadows were misleading, the depth and distance~     perception were weakened, and the linear perspective was lost. Visual perception is of~     primary importance for spatial orientation and object recognition because the static~     vestibular (otolithic) and proprioceptive signals are absent when free-floating.~     Consequently, astronauts become increasingly dependent on vision to perceive motion and~     orientation. All these factors play an important role in the adaptation of humans to~     spaceflight that needs to be analyzed to understand the underlying mechanisms that regulate~     human psycho-physiological adaptive process to changing gravity. Human psycho-physiological~     health has to be safeguarded and possibly improved when long-term human space missions are~     programmed in the near future.~      The primary objective of this experiment is to investigate if the SWI illusion is present in~     altered gravity environments. Since weight cannot be estimated in 0G, investigators have~     developed a procedure during which the subject is asked to estimate the objects' mass by~     shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion~     (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D~     visual perception in 0G, particularly in the height of 3D objects, as well as the change in~     proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to~     1G. In a separate proposal, investigators will also propose to perform this experiment using~     the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal~     force levels, to further investigate the role of proprioceptive cues in the size-mass~     illusion.~   "
42001|NCT02507440|"~     To find out if the administration of the local pharyngeal anesthetic, lidocaine, in~     conjunction with Propofol during elective Esophagogastroduodenoscopy (EGD) is useful, safe~     and impacts the time of discharge of patient compared to placebo.~   "
42002|NCT02507427|"~     To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during~     robot assisted laparoscopic radical prostatectomy for preservation of erectile function.~   "
42003|NCT02507414|"~     It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common~     event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of~     the syndrome is an important factor in provoking further peri- and postoperative~     complications and in worsening the surgical stress response (SSR). The characteristics of~     MTS is hypotension, tachycardia, and flushing.~      In order to uncover the role of MTS in cancer surgery and the effects on the oncological~     patients, the aim of the project is:~      1. To characterize MTS in patients undergoing three common forms of UGC surgery using a new~     objective methodology and by recording biomarkers suspected of playing a role in the~     pathophysiology of MTS and postoperative complication development.~      Three different interventions will be examined during this prospective trial:~        1. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast~          Imaging during surgery.~        2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively.~        3. Continuous measurements of haemodynamic variables during surgery.~   "
42004|NCT02507401|"~     The purpose of this study is to determine whether the mix of microbial species isolated from~     biofilm-clogged voice prostheses is specific to each participant, whether the microbes are~     orally-derived and whether the presence of specific species is a predictor of the frequency~     with which patients discard devices due to malfunction. The microbes isolated from discarded~     devices will be used to test the antimicrobial properties of newly-developed medical~     silicones.~   "
42005|NCT02507388|"~     The purpose of this study is to assess the systemic pharmacokinetics (PK) of RTH258 in~     subjects (Japanese and non-Japanese ethnicity) with neovascular Age-Related Macular~     Degeneration (AMD).~   "
42006|NCT02507375|"~     This study will assess the safety and tolerability, and make a preliminary assessment of~     activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or~     metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior~     chemotherapy regimen. The anticipated time on study treatment is until disease progression~     or unacceptable toxicity, and the target sample size is less than 100 individuals.~   "
42007|NCT02507362|"~     the purpose of this study is to compare the efficacy and safety of a new method of corneal~     cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known~     Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)~   "
42008|NCT02507349|"~     Fifteen minutes is the typical length of an outpatient medication management appointment for~     people with serious mental health conditions. These brief interactions with prescribers are~     frequently provider-driven with insufficient time focused on the patient's needs and~     personal recovery. Shared decision making is a strategy that could improve this interaction.~     This study examines how technology can be used in the care process to amplify the voice of~     the patient, support shared decisions, and improve treatment outcomes.~      Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care~     on two primary patient-centered outcomes: the patient experience of care with medication~     treatment and the level of shared decision making. Investigators hypothesize that:~        1. Person-Centered Care will result in greater improvement in patient experience of care~          with medication treatment than Measurement-Based Care.~        2. Person-Centered Care will result in a greater level of shared decision making during~          the medication visit than Measurement-Based Care.~      The study team will collect information from patients, caregivers, and clinic staff at~     different points in time during the study. Patients will be asked to complete~     questionnaires, and additional data on their service use will be gathered. Some patients and~     providers will also be interviewed about their experiences with care. Investigators are~     especially interested to learn if and how these two approaches are perceived to change~     medication treatment, if patients are more satisfied and empowered in their care, and why~     and how providers perceive and adopt changes to their clinical care.~   "
42009|NCT02507336|"~     The study seeks to provide long-term follow-up and/or to offer continued maintenance~     thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be~     followed until withdrawal of consent, or death.~   "
42010|NCT02507323|"~     This study has been designed as a randomized, double-blind trial to provide definitive~     evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with~     anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous~     Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs.~     prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis~     that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at~     risk when compared to prasugrel.~   "
42014|NCT02507271|"~     The purpose of this project is to test the hypothesis that Speed of Information Processing~     (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals~     with acquired brain injuries have speed of information processing deficits as part of the~     cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the~     efficacy of computerized cognitive Speed of Information Processing (SIP) training in~     individuals with ABI.~      Study participants will be asked to attend two study visits over the course of approximately~     13 weeks. Participants will be randomly assigned to either the experimental or control~     group.~   "
42015|NCT02507258|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study~     to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
42016|NCT02507245|"~     The aim of this study is to assess the developmental patterns of lung function in children~     affected by growth hormone deficiency after one year of GH therapy.The assessment by~     specific questionnaires of quality of life and of parental stress index.Parameters will be~     evaluated at the time of the diagnosis and after 12 months of GH therapy.~   "
42017|NCT02507232|"~     The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device~     in patients with low-grade glioma when it's used by itself or used together with~     temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or~     without temozolomide, is associated with fewer negative side effects on mental function that~     may be seen with other currently used treatment options.~   "
42018|NCT02507219|"~     The aim of this project is to determine whether the acute oral administration of Ibuprofen~     changes the activation pattern in the amygdala and other brain structures during functional~     magnetic resonance imaging. The investigators use a double-blind, randomized,~     repeated-measures design. Each of the 20 healthy control subjects will be tested three times~     and receive placebo, 200 mg or 600 mg dose of ibuprofen p.o. The study will consist of 4~     sessions: a baseline screening session and 3 testing sessions scheduled 1-2 weeks apart.~     Each of these individuals will undergo a multi-level assessment based on the RDoC approach~     that consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires~     assessing the positive and negative valence domains as well as interoception, (c) behavioral~     tasks assessing reward-related processing, avoidance, and aversive processing, cognition,~     and interoception; (d) physiological measurements consisting of facial emotion expression~     monitoring, heart rate and respiration, (e) functional magnetic resonance imaging focusing~     on reward-related processing, fear conditioning and extinction, cognitive inhibition, and~     interoceptive processing, and (f) biomarker assessments.~   "
42019|NCT02507206|"~     The purpose of the study is to examine the effects of the administration of a drug called~     DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD).~     DAR-0100A has not been FDA approved, however in recent studies has been used to treat~     cognitive deficits, meaning problems in the way you organize your thinking, in people~     diagnosed with schizophrenia.~      Many people who carry a diagnosis of schizotypal personality disorder have trouble with~     attention and memory. Increasing the presence of a brain chemical called dopamine has been~     found to help people with schizophrenia with their attention and memory problems. This study~     will investigate whether the same is true for people with schizotypal personality disorder~     by using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people~     with Parkinson's disease by increasing dopamine effects. Information collected in this~     experiment may lead to a better understanding of the brain mechanisms involved in~     schizotypal personality disorder and improve treatments for the psychological problems~     associated with this condition.~   "
42020|NCT02507193|"~     The primary objective of this study will be to evaluate the functional outcome of patients~     who present with a distal fibula fracture who were treated with either intermedullary nail~     (IMN) fixation or plate fixation.~   "
42021|NCT02507180|"~     This is prospective cohort study, in pregnant women who present with signs and symptoms of~     possible deep vein thrombosis. All patients will have the same method of assessment of their~     DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done)~     to determine if a compression ultrasound is required. All patients will be followed for a~     period of 3 months.~   "
42022|NCT02507167|"~     The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2~     on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a~     single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of~     endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose~     standardized liquid mixed meal.~   "
42023|NCT02507154|"~     This study aims to determine the safety and efficacy of expanded activated autologous NK~     cells administered after cetuximab in patients with EGFR-positive nasopharyngeal carcinoma~     or head and neck squamous cell carcinoma.~   "
42024|NCT02507141|"~     The purpose of this study is to get images (pictures) of oral lesions, which occur inside~     the mouth, before the patient's surgery using a special camera. These pictures will be used~     in our research to evaluate a new technology that uses a laser and takes pictures of the~     microscopic structure of tissue. The technology is called reflectance confocal microscopy.~     We would like to compare what the camera sees to biopsies (pathology) of the same area. We~     will evaluate the pictures obtained from the patient to determine whether this technology~     may be useful in the future. We hope this technology can be used as a tool for early~     diagnosis of oral cancers and for guiding surgery.~   "
42025|NCT02507128|"~     The investigators planned to evaluate the effects of liraglutide on no-reflow in patients~     with acute ST-segment elevation myocardial infarction (STEMI).~   "
42026|NCT02507115|"~     This project will develop an intervention delivered through text messaging to reduce alcohol~     consumption and high risk drinking among adults who are enrolled as students in community~     colleges.~   "
42097|NCT02506075|"~     The primary objective of this study is to confirm and compare the effect of methods of~     transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients~   "
42029|NCT02507076|"~     This pilot clinical trial studies isolated limb perfusion with melphalan in treating~     patients with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as~     melphalan, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it~     directly into the arteries around the tumor may kill more tumor cells.~   "
42030|NCT02507063|"~     The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised~     ICP has many potential benefits. This includes having assessments that can be made at the~     bedside instead of requiring patient transport to CT or MRI, which in itself can cause a~     rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may~     prove useful in the emergency department (ED) setting in the evaluation of shunts used for~     cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate~     with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The~     investigators further hypothesize that ONSD changes will correlate with changes in ICP,~     making it a useful bedside tool for assessing ICP changes over time. This is a prospective,~     observational study using a convenience sample. Children who are 0 - 18 years old who have~     an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive~     Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years~     old who are determined to require a shunt revision following evaluation in the ED will also~     be included in the study. 10. After the invasive intracranial pressure monitoring device is~     placed, for every recruited patient, ONSD measurements will be taken and the ICP will be~     recorded 8 hours post placement and then repeated 3 times a day until the intracranial~     pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision~     patients, the investigators will obtain a measurement just before surgery, immediately~     post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise~     ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to~     not unnecessarily prolong the hospitalization~   "
42031|NCT02507050|"~     The aim of the study is to test whether, in patients with angina and flow limiting~     epicardial coronary artery disease, pre-treatment with Ivabradine, as opposed to beta~     blockers, will reduce post percutaneous coronary intervention induced microvascular~     dysfunction.~   "
42032|NCT02507037|"~     In this randomized controlled study, consecutive outpatients scheduled for elective~     colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before~     colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum~     plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston~     Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of~     procedure, patients' tolerance, and adverse events were also evaluated.~   "
42033|NCT02507024|"~     The aim of this project is to develop a disease specific patient reported outcome measure~     (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a~     questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV).~     Patients with AAV have inflammation in the small blood vessels leading to involvement of a~     range of organs and can suffer from ongoing disease activity or treatment side effects.~     Quality of life can be measured by patient reported outcome measures (PROMs).~   "
42034|NCT02507011|"~     The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded,~     crossover trial of carvedilol in 26 PAH patients with World Health Organization functional~     class II or III symptoms and RV ejection fraction (EF) < 45% for 6 months.~   "
42035|NCT02506998|"~     The purpose of this study is to determine the changes of quality of life of patients with~     allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte~     Extracts (DLE). All patients will receive DLE in combination with current guide~     lines-suggested standard medication.~   "
42036|NCT02506985|"~     The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in~     patients managed with rivaroxaban vs. standard care following treatment of pulmonary~     embolism (PE) with catheter-guided alteplase. Patients >18 years old who present with PE and~     are managed with catheter-guided alteplase will be screened for study inclusion. Patient's~     meeting inclusion/exclusion criteria will undergo informed consent. Immediately following~     completion of alteplase infusion, patients will be randomized to receipt of rivaroxaban 15~     mg oral bid for 21 days followed by 20mg oral daily or continuation on unfractioned heparin~     or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3. Blood~     samples will be taken within 2 hours of CDT completion prior to receipt of study treatment~     (study day 1), at 8h-12h, 24h, 48h, 5d (or prior to hospital discharge), and at 30 day~     follow-up. Clinical endpoints, including bleeding, evidence of thrombosis progression, and~     death will be tracked during index hospitalization and at follow-up 30 days post-discharge.~   "
42037|NCT02506972|"~     The purpose of this study was to determine the impact of serving size and the addition of~     sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of~     rice cereal.~   "
42038|NCT02506959|"~     The goal of this clinical research study is to learn if a combination of panobinostat,~     gemcitabine, busulfan, and melphalan and a stem cell transplant can help to control MM. The~     safety of this combination will also be studied.~   "
42050|NCT02506803|"~     Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international~     oncology meeting and represents a new standard regimen in the treatment of metastatic~     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy~     as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only~     two cycles (three times weekly and one week rest) of GEMABR regimen.~   "
42051|NCT02506790|"~     This study evaluates the addition melatonin and metformin to toremifene in the treatment of~     locally advanced breast cancer. Third of patients will receive toremifene, other third will~     receive combination of melatonin and toremifene and other patients will receive combination~     of metformin and toremifene.~   "
42052|NCT02506777|"~     This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC~     (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast~     cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of~     melatonin and FDCх6 cycles and other patients will receive combination of metformin and~     FDCх6 cycles.~   "
42039|NCT02506946|"~     This project focuses on an at-risk adolescent and young adult population who may gain~     long-term health benefits from detection of risk factors at a young age. The primary aims of~     this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary~     Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by~     studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To~     assess the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver~     disease (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls.~      In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable~     control subjects will be evaluated for metabolic disturbances and elevated liver fat using~     noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry~     and an oral glucose tolerance test in order to fully assess the metabolic and body~     composition differences between these groups. This research proposal represents a critical~     step in understanding the metabolic and cardiovascular comorbidities of PCOS and their~     relationship to NAFLD. The investigator hopes to use the results generated by this research~     proposal in order to lay the groundwork for the prevention and treatment of metabolic~     disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong~     morbidity associated with this common disorder.~   "
42040|NCT02506933|"~     This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus~     (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients~     previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV~     is a virus that may reproduce and cause disease and even death in patients with lowered~     immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small~     pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe,~     weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity~     (the ability to recognize and respond to an infection) to CMV. This may help to reduce both~     CMV complications and reduce the need for antiviral drugs in patients undergoing a donor~     hematopoietic cell transplant.~   "
42041|NCT02506920|"~     The investigators wanted to study the postprandial lipemia after six oral fat tolerance test~     with varying amounts of saturated fat in young healthy subjects.~   "
42042|NCT02506907|"~     The overall aim of this work is to assess the relationship between stroke risk and~     hemodynamic compensation strategies, as measured using a novel 3.0 Tesla MRI protocol, in~     patients with symptomatic intracranial (IC) steno-occlusive disease. Recent studies have~     shown high two-year ischemic stroke rates in symptomatic patients with IC arterial stenosis.~     Therapy for IC stenosis patients includes revascularization with angioplasty, IC stenting,~     or bypass, however identification of patients most likely to benefit from these more~     aggressive interventions, rather than medical management alone, has been problematic.~     Accurate measurements of hemodynamic compromise are likely required to better define stroke~     risk and guide treatment decisions. Specifically, in IC stenosis patients with compromised~     cerebral perfusion pressure (CPP), the extent of hemodynamic compromise reflects the~     autoregulatory capacity of vasculature to increase arterial cerebral blood volume (aCBV)~     and/or develop collaterals to supplement cerebral blood flow (CBF). The prevalence of CBF~     collateralization and aCBV autoregulation has been hypothesized to correlate uniquely with~     stroke risk, however the extent of this correlation has been debated. The critical barrier~     to stratifying stroke risk rests with a lack of (i) methodology for measuring multiple~     hemodynamic factors with high specificity and (ii) noninvasive approaches capable of~     monitoring longitudinal progression of impairment. The investigators have demonstrated the~     clinical utility of relatively new, noninvasive MRI approaches for assessing cerebrovascular~     reactivity (CVR), aCBV, and collateral CBF. The investigators hypothesize that stroke risk~     can be more completely evinced from collective measurements of these parameters. Therefore,~     the investigators propose to implement a novel, validated hemodynamic MRI protocol to assess~     tissue-level impairment and compensation strategies in patients with IC stenosis. Using a~     collective approach combining measurements of collateral CBF, aCBV and CVR in multiple brain~     regions, in conjunction with a statistical model incorporating the above variables as~     possible prognostic factors, the investigators will quantify the extent to which two-year~     stroke risk is associated with hemodynamic compensation mechanisms. The noninvasive and~     multi-faceted scope of this investigation is intended to expand the diagnostic stroke~     infrastructure and elucidate new hemodynamic prognostic indicators of stroke in this~     high-risk population.~   "
42043|NCT02506894|"~     Two groups of women with preterm labor will be included. One will receive magnesium sulfate~     for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler~     indices will be measured before and after intake of either magnesium sulfate or placebo to~     find if any significant changes occur in fetal cerebral blood flow.~   "
42044|NCT02506881|"~     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and~     safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen~     Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate~     the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single~     subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a~     dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval~     of at least 25 days.~   "
42045|NCT02506868|"~     The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and~     Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.~   "
42046|NCT02506855|"~     This study attempts to learn about the effectiveness of a modification to the Transversus~     Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the~     abdominal wall postoperatively using ultrasound guidance. The investigators want to see if~     regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread~     in the appropriate plane could reduce error and improve postoperative recovery.~   "
42047|NCT02506842|"~     The purpose of this study is to investigate the activity and safety of second-line adjuvant~     therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and~     fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.~   "
42048|NCT02506829|"~     The investigators plan to compare the impact of two approaches for smoking cessation on~     smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse~     population of patients at the Manhattan campus of the VA New York Harbor Healthcare System,~     which serves a critical safety-net role for urban veterans. During hospitalization, all~     smokers will receive usual care. Patients will be randomized to one of two arms: financial~     incentives plus usual care vs. usual care alone, which includes referral to the state~     Quitline. All patients enrolled in the study will be offered nicotine replacement therapy.~     The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12~     months after discharge. The primary study outcome is smoking abstinence at 6-month~     follow-up, verified by salivary/urinary cotinine.~   "
42049|NCT02506816|"~     The primary objective of this study is to identify, in human tumour samples, biomarker~     changes associated to short exposure to AZD2281 as potential predictors of activity in~     Endometrial Carcinoma (EC).~      This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety~     are not a primary objective of the study.~   "
42054|NCT02506738|"~     The aim of the study was to demonstrate the effectiveness of telemonitoring functional~     status and vital signs to early detect heart failure exacerbation, and to minimize~     readmissions and length of hospitalisations.~      Patients over 75 with heart failure were included after a hospitalisation due to heart~     failure exacerbation. Patients were assigned randomly into intervention or control. The~     intervention group comprised 47 patients who were assessed through telemonitoring, while 40~     followed traditional clinical pathways.~      Patients were followed-up for 3 months after discharge, collecting emergency visits and~     readmissions due to a new heart failure exacerbation. Those patients in the intervention~     group used a commercial telemedicine system: Careline H@me, which was provided by the~     company SALUDNOVA. They system was personalized by adding the functional status monitoring~     capabilities. Thus, the system collected vital signs (i.e. blood pressure, heart rate,~     respiratory rate, oxygen saturation, glucose, and weight); symptoms of decompensated heart~     failure (i.e. dyspnoea and orthopnoea); and functional status (i.e. part of the Short~     Physical Performance Battery, SPPB) and a brief questionnaire (i.e. Do you have the~     medication?) every 48 hours.~      Two staff geriatricians at the Hospital Universitario de Getafe accessed, during working~     days, a secured dedicated web-portal to assess the progression of their patients, evaluated~     through the monitored variables and the self reported symptoms. They reacted to the data, if~     needed, making a phone call or visiting the patient. Besides, patients could contact the~     geriatricians or attending the emergency room as usually.~      After completion, we analysed the results. First, we carried out a descriptive analysis of~     the data. Later, we analysed the effects of the intervention with telemedicine and the~     predictive values of the different measured variables through logistic regressions.~   "
42055|NCT02506725|"~     The goal of Quarenta Semanas is to remove risk factors for preterm birth by linking women to~     prenatal care in the first trimester; supporting, educating and empowering women in~     pregnancy to reduce maternal stress and interrupt social, psychological, attitudinal and~     biological risk factors for preterm birth; and providing evidence-based, quality care that~     identifies and intervenes medically to treat underlying chronic and emergent conditions~     associated with preterm birth.~   "
42056|NCT02506712|"~     The main objective is to quantify energy expenditure when using the SmartDrive system during~     manual wheelchair propulsion in external conditions (slope, straight line). For this two~     comparisons are performed:~      Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute~     propulsion test.~      Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion~     test.~   "
42057|NCT02506699|"~     For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has~     found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by~     some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted~     through a neurosurgical procedure. This is common practice at the University Hospital of~     Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in~     our center only a non-invasive technique for patients challenged with brain surgery, since~     according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated~     to the repetition of sessions.~      Assessment centers and the treatment of pain allow a multidimensional assessment,~     bio-psycho-social of patients in order to optimize their management and experience~     efficiently analgesics first- and second-line.~      We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation~     parameters reproduced according to a literature review, during 3 months after 5 active~     sessions separated by one week apart, in 15 patients with neuropathic pain chronic~     refractory to treatment of first and second line, followed by multidisciplinary center~     specializing in chronic pain Lower Normandy. The quality of life will also be assessed by~     validated scales, and the results will be compared to the literature data.~   "
42058|NCT02506686|"~     A prospective, open-label study investigated the pharmacokinetic profile of meropenem in~     patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB~     penetration into cerebrospinal fluid (CSF).~   "
42059|NCT02506673|"~     Little is known about perioperative stress responses and possible anxiety mitigating factors~     like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective~     questionnaires, and are not based on real-time gathered data. Skin conductance measurements~     allow the sympathetic discharge to be evaluated down to fractions of a second and enable us~     to continuously monitor stress responses as skin conductance responses/per second during the~     perioperative management. In our study, the investigators propose to examine the effect of~     personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and~     overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia.~     Patients will be randomly assigned to either receive traditional sedation or light sedation~     in addition to audiovisual equipment. The investigators hope to determine outcome estimates~     of the use of this equipment on stress levels using skin conductance measurements, request~     for further sedation, postoperative pain levels and analgesic consumption, time to discharge~     readiness, and overall patient satisfaction, and collect thus far unavailable data on the~     stress response to perioperative stresses (such as IV insertion and spinal placement) in~     order to allow for power analyses for future studies.~   "
42060|NCT02506660|"~     Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain~     after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a~     corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The~     addition of higher doses of dexamethasone to nerve blocks, which are injections of local~     anesthetics into the upper shoulder area, has been shown to prolong block duration and~     reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs~     patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent~     studies have shown that systemic, intravenously administered dexamethasone may similarly~     reduce pain levels when compared with dexamethasone in the block. In our study, the~     investigators propose to examine the effect of low-dose IV versus block dexamethasone on~     interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have~     used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses.~     Our aims are to determine whether the addition of low-dose dexamethasone to a local~     anesthetic in the block can prolong its duration, and whether there are differences in~     postoperative pain, consumption of painkillers, side effects, and satisfaction in patients~     who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to~     either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller~     use, side effects, block duration, satisfaction, complications) will be made via phone at 2,~     3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether~     patients prefer the longer-duration analgesia that may be obtained with low-dose~     dexamethasone in the block.~   "
42125|NCT02505711|"~     The aim of this study is to evaluate the potential of reducing young child undernutrition in~     low-income countries through an integrated program that trains women's groups in~     agriculture, nutrition, child care and hygiene.~   "
42062|NCT02506634|"~     Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with~     upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy~     or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux~     was defined as the percentage total time for which a pH value < 4 was >4.2 % in the distal~     esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The~     symptom scores were measured by the frequency score multiplied by the severity scores of the~     predominant symptom before and at the end of the treatment, and the  PPI test  was defined~     as positive if the overall scores of the predominant dyspeptic symptom in the fourth week~     decreased by >50 % compared with those of the baseline.~      GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump~     inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in~     the symptom questionnaire in Chinese outpatients in Gastroenterology department will be~     calculated. The symptom of the highest percentage will be the primary symptom.~   "
42063|NCT02506621|"~     Randomised crossover study comparing the sensitivity and specificity of 5 External loop~     recorders in detecting pacemaker detected Atrial fibrillation burden.~   "
42064|NCT02506608|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might~     be elicited or worsened by a range of physical factors (e.g. changes in the weather or~     pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well~     known that most treatments available for PLP today, such as pharmacological, surgical,~     anaesthetic, psychological and other, are ineffective. Today it is believed that phantom~     limb pain may be related to changes in the cortex of the brain. There is evidence that these~     changes may be modulated - or even reversed - by providing sensory input to the stump or~     amputation zone. For example, cortical reorganization and alleviation of phantom limb pain~     has been observed in amputees following intense use of a hand prosthesis. However, there is~     no consistent knowledge on which type of peripheral sensory feedback may be effective in~     affecting the cortical plasticity or on how to best apply the sensory feedback. The aim of~     the proposed research is to create natural, meaningful sensations through providing~     non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to~     alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
42065|NCT02506595|"~     The purpose of this study is to obtain preliminary data of the efficacy of Exposure,~     Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.~   "
42066|NCT02506582|"~     The purpose of this randomized, double-blind, placebo-controlled study was to determine~     whether jerusalem artichoke and fermented soybeans powder mixture is effective in the~     control of blood glucose level in subjects with prediabetes or newly diagnosed type 2~     diabetes.~   "
42067|NCT02506569|"~     The investigation is designed to provide supporting evidence for the clinical safety of the~     Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3~     Tesla MR conditions .~   "
42068|NCT02506556|"~     This is a phase II, exploratory, open-label, single arm study of BYL719 monotherapy, a~     selective phosphatidylinositol 3-kinase (PI3K) alpha inhibitor, in adult patients with~     advanced metastatic breast cancer progressing after first line therapy. Patients with~     advanced hormone receptor positive tumors will be required to have an alteration of the PI3K~     pathway. Those patients with advanced triple negative breast cancers are genetically~     unselected for this study.~   "
42069|NCT02506543|"~     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls~     in three refugee camps in Ethiopia. The study design will employ a two group wait-list~     cluster randomized controlled trial where girls will be invited to participate in the~     COMPASS program, assigned to groups of approximately 20 for the purposes of the program,~     complete a pre-test baseline assessment, and will then be randomized by group to the~     intervention or control condition. In addition, qualitative research will address additional~     questions of acceptability, processes of change and best practice.~      Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to~     determine whether the participants receive the intervention or are placed on the wait-list~     immediately following the baseline. Those that do not get the curriculum during the study~     will receive it following the endline phase of the study so as to not create tensions or~     jealousies.~      The intervention, the COMPASS program, will involve a structured intervention for girls~     between the ages of 13-19 that is intended to engage adolescent girls, those who are~     influential in their lives, service providers and other stakeholders, with the ultimate goal~     of co-creating environments in which girls are valued and safe. The program is centered on~     establishing or supporting community-supported safe spaces for girls where they can come and~     gather among themselves and participate in a structured life-skills curriculum.~   "
42070|NCT02506530|"~     This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive~     treatment in reducing secondary lymphoedema in breast cancer.~   "
42071|NCT02506517|"~     This is a phase 2 study (the second phase in testing a new drug) to see how useful an~     investigational drug called afatinib is in patients with advanced cancer with changes in the~     HER gene.~      Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung~     cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein~     called HER from working. HER is an important protein that contributes to the growth of~     cancer cells.~   "
42072|NCT02506504|"~     In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is~     severely impaired due to a ventilatory limitation, levelling off the intensity of exercise.~     This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is~     then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the~     intensity and the duration of every training session. In a preliminary study, the~     investigators showed that IPS applied during an exhaustive cycling exercise allowed to~     prevent the onset of post-exercise quadriceps fatigue evaluated by the endurance time to~     isotonic quadriceps contractions (TlimQ).~      The aim of this study is to determine the relationship between the prevention of~     post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of~     sessions) during a pulmonary rehabilitation programme. At the beginning of the training~     programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal~     workload) with and without IPS in random order. The training load was then monitored at~     every exercise session of the programme.~   "
42074|NCT02506387|"~     The primary objective of the registry is to investigate and follow all patients treated with~     the MitraClip System in Belgium. This information is intended to contribute to decision~     making with regards to MitraClip therapy selection in patients with mitral regurgitation:~     (a) by establishing the clinical value of the MitraClip therapy in the continuum of care;~     and (b) by providing practical information that will allow physicians to make therapeutic~     decisions, assist hospitals to make purchasing decisions, and assist insurers/government in~     making coverage decisions.~      In addition national data will be shared with European registries in order to increase the~     knowledge about the efficacy of this new technique.~   "
42075|NCT02506374|"~     This non-intervention qualitative study will use focus groups to assess the feasibility and~     acceptability of a proposed intervention for a future study. The focus group will discuss a~     potential biobehavioral family self-management intervention designed to improve sleep in~     persons with Alzheimer's disease (PAD) and their caregivers (CG).~   "
42076|NCT02506361|"~     This is a prospective、multicenter、non-comparative interventional case series. 800 breast~     cancer patients who have already received chemotherapy prior to this study will be enrolled~     in the group, including 400 patients received the anthracyclines followed taxanes~     chemotherapy, and the other 400 patients who have received regiments containing no taxanes.~     Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay.~     Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α~     expression and 5- year or 10-year disease free survival(DFS) and overall survival（OS）will be~     identified in this study.~   "
42077|NCT02506348|"~     In this study we test Diclofenac and Nepafenac and compared patients experience and comfort~     following administration of these ophthalmic drops.~   "
42078|NCT02506335|"~     Background: It is still difficult to predict the outcome in patients requiring Fontan~     Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis~     requiring major cardiac surgery including heart transplant. Over the years, many prognostic~     indices have been derived from laboratory results of blood tests, clinical and physiological~     variables (or some combination thereof), from liver imaging to liver histology, which has~     issues of sampling error, medical risks and technical difficulty. None of these have proved~     entirely satisfactory. Predicting morbidity or survival is particularly important when~     deciding about Fontan revisions versus the need for heart transplantation. What is needed~     here is a truly reliable test of liver function that can help predict outcome, on the basis~     of a single measurement within few days of a planned revision. For this purpose, it is~     desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform,~     have a rapid turnaround for results, and be readily repeatable.~      Tests of hepatic elimination of various exogenous substances have been described, such as~     galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine~     metabolism to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic~     capacity. None of these metabolic or clearance tests achieved widespread acceptance or use,~     mostly because their performance and analyses were cumbersome.~      HepQuant,LLC has developed a platform of tests of liver function which include Systemic~     Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2.~     HepQuant tests specifically target the hepatic uptake of cholate and use a single~     noninvasive test of 90 minutes duration to quantify the systemic circulation, portal~     circulation, and portal-systemic shunt and to derive a DSI in intact human subjects.~     HepQuant tests can assess all stages and etiologies of liver disease. In chronic HCV~     patients HepQuant testing can predict which patients will respond to antiviral therapy and~     can measure the improvement in hepatic function that occurs after successful antiviral~     therapy. Patients who did not respond were followed for an average of 5 years and up to 8~     years, and baseline HepQuant testing could predict clinical outcomes (CTP progression,~     variceal bleeding, encephalopathy, ascites, liver-related death) with 87% sensitivity and~     71% specificity.~   "
42079|NCT02506322|"~     This efficacy study compares an adjuvant specific psychotherapy and an active control~     intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain~     remission. Patients should be in their early (18-30 yr.) phase of illness without having~     suffered of to many affective episodes (below 6), already. In addition, psychological,~     social, and neurobiological mediators and moderators well be identified.~   "
42080|NCT02506309|"~     Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress~     urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be~     as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A~     third generation of the MUS inserted through a single vaginal incision (SIS) has become a~     means to overcome significant post-operative groin pain. Novel types of SIS with a more~     robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the~     obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an~     innovative fixation SIS in randomized controlled trial on patients undergoing their primary~     surgery for urodynamic SUI.~   "
42081|NCT02506296|"~     Patients with type 2 diabetes have very variable endogenous insulin secretion. While some~     patients have relatively preserved endogenous insulin with marked insulin resistance others~     may develop the very severe insulin deficiency seen in type 1 diabetes. The impact of this~     variation on hypoglycaemia risk and treatment response in type 2 diabetes is unclear. This~     project aims to determine the impact of residual endogenous insulin secretion on glucose~     variability, hypoglycaemia risk and treatment response in insulin-treated participants with~     a clinical diagnosis of type 2 diabetes. The investigators will recruit participants from~     existing cohorts known to have severe insulin deficiency despite classical clinical~     characteristics of type 2 diabetes. The investigators will recruit other participants with~     insulin-treated type 2 diabetes and retained endogenous insulin secretion matched for~     glycemia and gender. The investigators will assess glucose variability (using continuous~     glucose monitoring system (CGMS)) and treatment response to a single dose of the glucose~     lowering therapy vildagliptin and compare responses between groups. This study will allow us~     to assess the potential utility of measuring endogenous insulin secretion in insulin-treated~     type 2 diabetes as a marker of hypoglycaemia risk and in determining likely response to oral~     therapy.~   "
42082|NCT02506283|"~     This study investigates the effects of cooling on the recovery and performance~     characteristic in young healthy subjects. The study is divided in two projects:~      Project A: investigates the effects of 20 min. post-exercise cooling on vertical jump~     performance and delayed onset muscle soreness and rated perceived exertion.~      Project B: investigates the effects of 20 min. pre-exercise cooling on maximal voluntary~     contraction of the right M. quadriceps femoris and delayed onset muscle soreness and rated~     perceived exertion.~   "
42083|NCT02506270|"~     The aim of the investigators' study is to investigate if the use of the AirSeal insufflation~     system impairs ventilatory parameters of patients less than a conventional system in~     patients undergoing robot-assisted laparoscopic cystectomy.~   "
42085|NCT02506244|"~     The purpose of this study is to investigate whether it is possible to identify a high-risk~     cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and~     then engage those individuals in a mobile health technology-enabled home monitoring program~     in order to document previously undiagnosed atrial fibrillation, and provide clinical~     evidence of an outcomes benefit associated with this early detection.~   "
42086|NCT02506231|"~     The purpose of this study is to assess the impact of folinic acid (FA) -rescue following~     methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity~     and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT)~     in a double blind randomized controlled trial.~   "
42087|NCT02506218|"~     This study will be conducted using standardized techniques to collect blood samples via an~     acute, randomized, cross-over design. Subjects will be provided all of their meals the day~     prior to testing and participate in 3 testing days with a minimum of 1 week break between~     testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a~     catheter and collect blood samples from an antecubital vein using sterile techniques.~   "
42088|NCT02506205|"~     A handful of studies have examined the effects of the Lee Silverman Voice Treatment (LSVT)~     LOUD on hypokinetic dysarthria in English speakers with Parkinson's disease (PD). Although~     LSVT LOUD has been found to be effective on improving these speaker's vocal intensity and~     increasing their speech intelligibility as well as speech function with Phase I evidence, no~     study has investigated whether Mandarin-speaking individuals with dysarthria secondary to PD~     would benefit from LSVT LOUD. In the proposed study, speech data of Mandarin-speaking~     individuals with hypokinetic dysarthria before and after speech therapy will be audio~     recorded and analyzed in order to examine the effects of LSVT LOUD on the speech function in~     this population. The same speech data will be played to Mandarin listeners in order to~     investigate the speech intelligibility of this population. It is hypothesized that~     Mandarin-speaking individuals with hypokinetic dysarthria secondary to PD will demonstrate~     reduced vocal intensity, reduced speech intelligibility and impaired speech function before~     they receive LSVT LOUD. They will improve these speech characteristics following speech~     therapy and will present with short-term maintenance effects.~   "
42089|NCT02506192|"~     The primary objective of this clinical trial is to determine if treatment with an~     anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of~     life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a~     change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary~     outcomes measures include changes from baseline levels of GWI-associated biomarkers of~     inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and~     cognitive impairment), and HRQOL with respect to mental functioning.~   "
42090|NCT02506179|"~     To evaluate the real-life effect of adalimumab on psychological distress/depression symptoms~     in moderate-to-severe Ulcerative Colitis (UC) patients~   "
42091|NCT02506166|"~     The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden~     cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The~     ESCAPE - SCD Study will address following specific study questions:~        -  Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk~          factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM)~          indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC)~          Guidelines for primary prevention of sudden cardiac death?~        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive~          Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM~          patients?~        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy~          improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?~        -  Does obstructive sleep apnea represent a novel factor that may improve risk~          stratification of sudden cardiac death and advance identification of those patients~          that will benefit from ICD/CRT-D therapy?~   "
42092|NCT02506153|"~     This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or~     ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma~     that has been removed by surgery but is likely to come back or spread. High-dose recombinant~     interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies,~     such as ipilimumab and pembrolizumab, may block tumor growth in different ways by targeting~     certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B or~     ipilimumab is more effective than pembrolizumab in treating patients with melanoma.~   "
42093|NCT02506140|"~     Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic~     receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides~     faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with~     acute coronary syndrome, irrespective of the genetic variants affecting Clopidogrel~     metabolism. It is still undefined whether combination therapy of Ticagrelor and Aspirin is~     more effective than Clopidogrel and aspirin for minor stroke and transient ischemic attack~     (TIA). The primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a~     3-month regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day~     combined with aspirin 100 mg/day during first 21 days versus a 3-month regimen of~     clopidogrel initiated with 300 mg loading dose of followed by 75 mg/day combined with~     aspirin 100 mg/day during first 21 days when initiated within 24 hours of symptom onset in~     high-risk transient ischemic attack or minor stroke.~   "
42094|NCT02506114|"~     This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or~     the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized~     PC. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A), ipilimumab~     monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm C), prior~     to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the primary~     vaccine on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F~     subcutaneous administrations, given 3 weeks apart. In arms B and C, ipilimumab will be~     administered twice, at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab~     administration will coincide with the PROSTVAC-F administration. In arm B, ipilimumab will~     begin on Day 1. In all three arms, RP will occur 21 days, or three weeks, following final~     treatment administration of PROSTVAC or ipilimumab. No further therapy will be administered~     on study following RP.~   "
42098|NCT02506062|"~     This trial will test the efficacy of brief periods of controlled limb ischemia (remote~     ischemic preconditioning, RIPC) as an effective treatment of patients with Raynaud's~     Phenomenon (RP).The hypothesis of this trial is that due to its vasoprotective effects, RIPC~     would be more effective than placebo in the treatment of both primary and secondary RP, as~     defined by decreased frequency, duration, and severity of attacks. This trial was also~     designed to monitor the tolerance of RIPC in a rheumatologic population. Patients will not~     be required to stop any current treatment for RP.~   "
42099|NCT02506049|"~     Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser~     photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).~   "
42100|NCT02506036|"~     This study is being done to test the feasibility and effectiveness of web-based~     social-cognitive training exercises in treating social-emotional deficits in patients with~     stroke or frontotemporal dementia (FTD).~   "
42101|NCT02506023|"~     The purpose of this study is to determine how female hemophilia A carriers respond to a~     medication called DDAVP (Desmopressin).~   "
42102|NCT02506010|"~     The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation~     comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood~     saturation during non-motion conditions over the range of 60-100% SaO2 as measured by~     Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements~     will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.~   "
42103|NCT02505997|"~     The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin~     on the pharmacokinetic (PK) profile of a single oral dose of midazolam.~   "
42104|NCT02505984|"~     The purpose of this feasibility study is to test a new treatment for preventing~     childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing~     maternal bonding and reducing postpartum depression (PPD) and posttraumatic stress symptoms~     in mothers at risk. To this end, the investigators will test the clinical utility of~     intranasal oxytocin (IN-OXT) administered to mothers during the first postpartum days.~   "
42105|NCT02505971|"~     The purpose of this study is to assess the efficacy and safety of oral propranolol versus~     nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled,~     double-blinded study.~   "
42106|NCT02505958|"~     Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin~     resistance produced by several days of overnutrition. Approach: Healthy volunteers will be~     admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic~     clamp study to assess their insulin resistance. Subjects will then start on an overnutrition~     program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A~     second clamp study will be performed on day 5 to demonstrate the overnutrition induced~     increase in insulin resistance. Starting on day 5 the subject's caloric intake will be~     reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third~     hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric~     intake did reduce insulin resistance and the volunteer will be discharged from the Clinical~     Research Center.~   "
42107|NCT02505945|"~     This study compares mechanical sphincter augmentation (LINX Reflux Management System) to~     double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to~     gastroesophageal reflux disease (GERD).~   "
42108|NCT02505932|"~     To date, use of arthroscopic procedure to perform Latarjet procedure is still technically~     demanding. The benefits of arthroscopic procedure need to be evaluated compared to the~     mini-invasive approach. The aim of this study was to assess postoperative pain during the~     first week, and the positioning of coracoid bone block at the anterior aspect of the~     glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional~     evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.~   "
42109|NCT02505919|"~     A prospective multicenter randomized blinded study comparing Aquablation of the prostate~     with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS).~     The primary endpoints for safety and effectiveness will be measured at 3 and 6 months,~     respectively, and subjects will be followed out to 3 years to collect long-term clinical~     data.~   "
42110|NCT02505906|"~     In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment~     technique for early breast cancer. Radiotherapy has shown to give better local control and~     survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB)~     technique is a new treatment technique in breast irradiation. In this technique the whole~     breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late~     radiation-induced toxicity has not been investigated in patients treated with radiotherapy~     using this technique. Proposed study will study the late radiation-induced toxicity,~     describe patients-rated complaints, quality of life, survival and local control curves in~     patients treated for early breast cancer with breast-conserving surgery in combination with~     radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.~   "
42111|NCT02505893|"~     This is a prospective phase 2, single-arm, mono-center pilot study. It has been designed to~     investigate whether giving the combination therapy consisting of minimal islet~     transplantation (1500 EIQ/Kg body weight), Thymoglobulin® (ATG), Rapamune® (rapamycin) and~     Neulasta® (pegfilgastrim) to patients with Type 1 Diabetes (T1D) at onset is safe and~     secondarily, if it will preserve insulin production. It will involve 6 patients with~     new-onset T1D. Each patient will be involved in the study for a screening period and a~     post-islet transplantation study period of 52±2 weeks, to include 1 treatment cycles of 12~     weeks, assessment during treatment and 5 follow-up visits scheduled at weeks 2±1 (14 days),~     4±1 (month 1), 12±2 (month 3), 26±2 (month 6) and 52±2 (month 12).~   "
42235|NCT02504138|"~     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and~     long-term hepatic dysfunction after liver transplantation. Protecting the liver against I/R~     injury and maintaining hepatic function during transplant surgery is therefore very~     important in order to improve post-operative outcome. This purpose of this study is to~     investigate whether propofol anesthesia done in both liver donors and recipients during~     living-donor liver transplantation is effective in reducing liver I/R injury via its~     antioxidant and antiinflammatory properties and improve post-transplant outcome compared to~     desflurane anesthesia.~   "
42112|NCT02505880|"~     In adults, it is common to perform a number of superficial and non invasive surgeries under~     local anesthesia in order to limit the use of general anesthesia.~      Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the~     patient comfort and experience. The benefit of this practice has been widely demonstrated in~     adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and~     vomiting.~      In pediatric surgery, hypnosis is an effective technique for the management of preoperative~     anxiety. It is used by many teams in their daily practice, particularly during anesthetic~     induction.~      For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University~     Hospital also offers for selected short and superficial non-invasive surgeries, an~     intraoperative management under hypnosis in association with ocal anesthesia as an~     alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted~     and recognized in our intraoperative surgical unit, to date, no studies have evaluated the~     benefits of this technique compared to general anesthesia.~      The objective of the study is to compare the impact of these techniques (hypnosis vs.~     general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety,~     pain, nausea and vomiting, negative behavioral disorders).~   "
42113|NCT02505867|"~     The purpose of this study is to evaluate the effect of in-hospital diagnosis and treatment~     of sleep disordered breathing (SDB) on post-discharge mortality and readmissions in-~     hospitalized patients with acute heart failure syndrome and reduced ejection fraction~     (HFrEF).~   "
42114|NCT02505854|"~     The purpose of this study is to evaluate whether contribute with weight loss and improvement~     of blood sugar and lipemia in obese women.~   "
42115|NCT02505841|"~     The transversus abdominis plane (TAP) block is a regional anesthetic technique for post~     operative pain control after abdominal surgical procedures. Its effectiveness in children~     undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate~     its analgesic efficacy over the first 24 post operative hours.~   "
42116|NCT02505828|"~     The aim of this study is to find markers that could differentiate infectious and~     inflammatory arthritis. The investigators want to find markers by differential analysis by~     compare synovial fluids of septic and inflammatory arthritis. The investigators will use for~     this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis.~     The investigators will use one marker or a score with biological and clinical data to~     discriminate arthritis of infectious and inflammatory etiology.~   "
42117|NCT02505815|"~     Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory~     function and intellectual skills, which occurs after surgery with and without anesthesia.~     The POCD strongly depends on patient's age and the surgical operation type. The anesthesia~     procedure plays a pivotal role as well and regarding the current knowledge it is still~     uncertain which technique matches the lowest risk. Elevated stress level accompanied with~     regional anesthesia procedures are accused to cause POCD in elderly patients. The~     investigators address the question weather regional or general anesthesia leads to a~     pronounced POCD in dependence of stress incidence.~   "
42118|NCT02505802|"~     Botulinum toxin A (BoNT-A) injections are widely used to treat spasticity after stroke.~     Although this treatment is effective on muscle tone improvement, its effect on gait and~     ability of daily living on early stage of stroke adults remains uncertain.The purpose of~     this study is to determine whether an early calf muscle injection of low dose BoNT-A in~     severely affected patients within 6 weeks after stroke could help to hold back disabling~     muscle spasticity and improve walking dysfunction.~   "
42119|NCT02505789|"~     In many countries, numerous steps are taken to minimize the risk of infection from~     transfused blood products. Typically, blood banking organisations will screen for an array~     of infectious pathogens as part of their quality control protocol. While transmission of~     these tested agents via transfusion has become exceedingly rare, the risk of~     transfusion-transmitted infections for which testing is not currently performed continues to~     be a concern. Among these untested infectious agents is Epstein-Barr virus (EBV, also known~     as human herpesvirus-4). Most notably, infection with this virus in transplant recipients~     can give rise to a malignant disorder called post-transplant lymphoproliferative disease~     (PTLD), a life-threatening complication which is due to the uncontrolled expansion of~     EBV-infected cells. It is also associated with other complications such as hepatitis,~     hemophagocytic syndrome, etc. in transplant population. It is recognised that EBV infection~     can occurred in transfused immune suppressed graft recipients but the origin of the viral~     infection is still a matter of debate. It is a known fact that the EBV already present in~     the recipient's blood can undergo reactivation due to immune suppression. However, because~     it is known to occur more frequently in patients who are EBV-seronegative at the time of~     transplant, it is also accepted that primary infection contracted via an infected graft can~     be a source of virus. The question we are seeking to answer is whether immune suppressed~     graft recipients can acquire primary EBV infection via transfusion of blood products. EBV is~     present in the blood of most adults and cases of EBV transfusion-related infection have been~     reported. Transplant populations are generally transfused with very large volumes of blood~     products and our recent pilot study supports the possibility that transfusion-related EBV~     infection can be transmitted to pediatric hematopoietic stem cell (HSCT) recipients~     (Trottier et al, 2012). The aim of this study is to analyse the risk of EBV transmission~     through blood product transfusion in pediatric allogeneic HSCT patients.~   "
42120|NCT02505776|"~     This is a post-marketing surveillance study in Japan that will evaluate the safety and~     patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the~     treatment of hypotrichosis of the eyelashes.~   "
42121|NCT02505763|"~     The main objective of the study is to assess the cost-effectiveness ratio of two management~     strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a~     strategy without thoracic ultrasound.~   "
42122|NCT02505750|"~     Rationale - current state of knowledge Current guidelines for cT2-T3 (clinical stage T2 and~     T3) low and middle rectal cancer recommend radical total mesorectal excision (TME) surgery~     that may involves permanent stoma or a low anterior resection with sometimes poor bowel~     function.~      Randomised trials have shown that neoadjuvant (chemo)radiotherapy (nCRT) reduces the risk of~     local recurrence by more than half. At 3 years, it is close to or below 5% with acceptable~     toxicity at many centers. On the other hand, it provides no definite improvement in overall~     survival and does not increase the chances of conservative surgery.~      Rectal adenocarcinoma is rather radioresistant and the dose required to achieve 50%~     sterilization is close to 90 grays (Gy), which is a high dose causing toxicities when given~     with external beam radiation therapy (EBRT). Among the radiotherapy techniques able to~     achieve safely such a high dose, Contact X-Ray Brachytherapy 50 Kv (CXB) is an appealing~     method.~      The Lyon R96-2 randomised trial using CXB showed an increased clinical complete response~     (cCR) rate from 2% to 29% and an improvement by 30% the chance of avoiding a permanent stoma~     (72% vs. 42%). In addition, some patients achieving cCR were able to preserve not only the~     sphincter but the whole rectum (organ preservation) either after local excision or using~     only a watch and wait strategy.~      Such a conservative approach is receiving a growing interest all over the world among~     colorectal cancer specialists. The extensive and pioneering work of Prof. Habr Gama in~     Brazil is presently considered as a reference for the use chemoradiotherapy and an EBRT~     boost (total dose 54 Gy/30 f/6 weeks) followed by watch and wait in case of cCR to preserve~     organ, i.E. to avoid surgery.~      Research Hypothesis The investigators propose to conduct a randomised study on cT2, cT3a-b~     tumours less than 5 cm using two different techniques of radiotherapy boost following~     neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3~     fractions). The endpoint will be organ preservation at 3 years without non-salvageable local~     pelvic recurrence. The proof of this concept will be of most benefit for all patients but~     especially for the elderly who usually are not fit for or keen to undergo major surgery.~      The hypothesis of this study is to determine whether the addition of an endocavitary boost~     with CXB after standard treatment with nCRT, increases the chance of rectum and anus~     preservation by 20%-unites in early rectal adenocarcinoma without locally progressive~     disease (organ preservation in control arm 20%, in experimental arm 40%).~      Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost~     given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT~     alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease~     at 3 years post treatment start, or permanent deviating stoma.~      Study Design Open-label, phase III, prospective, multi-centre, international, randomised~     1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.~      Randomisation:~      Arm A: 3D conformal EBRT 45 Gy (1.8 Gy/fraction/5 weeks) with concurrent chemotherapy using~     capecitabine (825 mg/m2 bid, on radiation days).~      A cone down EBRT targeting the Gross Tumour Volume (GTV) will deliver a boost dose of 9 Gy~     in 5 fractions. On week 14 after the start of treatment, the tumour response evaluation will~     guide the final strategy: surgery (radical TME or local excision) or watch-and-wait (W-W).~      Arm B divided in 2 subgroups depending on the tumour diameter:~      B1: If the tumour is < 3 cm, a CXB boost dose (90Gy/3 fractions/4 weeks) will be initially~     delivered to the tumour. After 2 weeks rest, patients will receive 3D conformal EBRT 45 Gy~     (1.8 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (825 mg/m2 bid, on~     radiation days). Clinical evaluation will be performed 3 weeks after the end of irradiation~     (week 14) and will guide the final strategy (surgery or W-W) as in arm A.~      B2: If the tumour is ≥ 3 cm, patients will receive EBRT first 45 Gy (1.8 Gy/fraction/5~     weeks) with concurrent chemotherapy using capecitabine (825 mg/m2 bid, on radiation days).~      A CXB boost dose (90 Gy/3 fractions/4 weeks) will be delivered to residual tumour, after a~     rest of 2 weeks. On week 14 after the start of treatment, the tumour response evaluation~     will guide the final strategy (surgery or W-W) as in arm A. Adjuvant chemotherapy will be~     left to institution choice.~      Number of subjects: Taking alpha=5% and bêta=7.5% with 10% patients not evaluable after~     randomisation, 236 patients (118 patients/arm) must be enrolled to show a 50% increase in~     the main endpoint at 3 years (from 20% to 40%).This study will show a hazard ratio of 0.56.~     Stopping rule: non-salvageable local recurrence rate > 10% checked by the independent Data~     Monitoring Committee every 80 patients.~   "
42123|NCT02505737|"~     There is a critical need for treatments that address depression and barriers to mental~     health care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a~     10-session telephone-guided cognitive behavioral self-help program (TH-CBT) for depression~     in PD (dPD). 72 people with dPD (and their caregivers) will receive either TH-CBT plus~     enhanced usual care (INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups~     will be compared at baseline, midpoint, endpoint, and 1 and 6 months post-treatment.~     Participants assigned to the control group with have the opportunity to receive the~     experimental intervention (TH-CBT) after the data collection period (e.g., after the 6-month~     follow-up evaluation). Given the public health impact of improved depression treatment in~     PD, the knowledge to be gained may be significant and the project could directly impact~     clinical practice.~   "
42124|NCT02505724|"~     This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to~     teach novice surgical faculty an advanced laparoscopic skill.~   "
42236|NCT02504125|"~     A randomized, double-blind, single-center and controlled study comparing the efficacy and~     safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous~     bilateral total knee arthroplasty.~   "
42126|NCT02505698|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging~     technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology~     generates 3D metabolic maps of the breast and based on sophisticated machine learning~     technology, provides objective risk assessment for the presence of malignant tumor in the~     breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation.~     It is based on acquiring infrared images of the breast. Those images are processed and~     analyzed by computers to provide the objective risk assessment.~      The technology is intended to be used as a screening tool for breast cancer and emerges as~     highly useful in women for whom screening mammography is sub-optimal, such as women with~     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating~     patients with mammographically dense breasts.~      Real Imaging is continuously developing the technology including image acquisition hardware~     and objective analysis of the imaging biomarkers. To further improve and optimize this novel~     metabolic imaging technology, Real Imaging will introduce an improved imaging device.~      The purpose of this clinical study is to collect more imaging data in order to establish~     superiority of the newer device over the previous one.~      The investigators hypothesize is that the new device will be at least as good as the~     previous one.~   "
42127|NCT02505685|"~     The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess~     disease response to anti-cancer therapy in Lung Cancer patients.~   "
42128|NCT02505672|"~     Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects~     of this treatment on cochlear function is well characterized, its effect on vestibular~     function is not well studied.~      In this study the investigators will study the vestibular function of 50 patients undergoing~     chemoradiotherapy for NPC both before and after treatment in order to better define its~     effects. All patients will undergo a validated questionnaire (dizziness handicap index),~     posturography, audiometry and vestibular-evoked myogenic potentials.~   "
42129|NCT02505659|"~     Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to~     functional deficits which are difficult to overcome. To prevent from an unfavorable~     evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very~     common. Knee functional performance level could impact on the postoperative outcome and it's~     of common knowledge that early re-education after an ACR rupture improves knee functioning.~      Patients with an ACR rupture enrolled in this study will be randomized either in an~     experimental group (with preoperative reeducation) or in a control group (without~     preoperative reeducation). Both groups will then have post-operative re-education (40~     sessions) based on HAS recommendations.~      The main aim of this study is to assess the impact of preoperative re-education on knee~     functional performance 4 month after surgical reconstruction of an ACR.~      Secondary aims are to determine the impact of the 4-week preoperative re-education on knee~     functional performance after an ACR rupture, before surgery and 7 months after surgery.~      Functional performance, muscular strength, proprioception and anterior knee laxity will be~     measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M)~     after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the~     previous assessments.~   "
42130|NCT02505646|"~     Purpose:~      Fluid responsiveness in a context of circulatory failure can be predicted by different way.~     Dynamic criteria such as pulse pressure variation, stroke volume variation during an~     end-expiratory occlusion maneuver or a passive leg raising have been reported to predict~     fluid responsiveness. Only aortic velocity peak variation measured with transthoracic~     echocardiography during mechanical ventilation has been reported to predict fluid~     responsiveness in children. Besides some physician use a maneuver of abdominal compression~     to predict fluid responsiveness in children with circulatory failure. This strategy has~     never been formally evaluated.~      The investigators will study the diagnosis accuracy of the stroke volume variation induced~     by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in~     children with circulatory failure.~      Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the~     attending physician has decided a fluid load will be included. Hemodynamic parameters:~     arterial pressure, heart rate, stroke volume measured with echocardiography; will be~     recorded. This data collection will be performed before, after abdominal compression and~     after a fluid load of 10 ml/kg.~      Patients will be aposteriori sorted in two groups: Fluid responders and Fluid~     non-responders. Fluid responders are defined as patients that show an increase greater than~     15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an~     abdominal compression to predict fluid responsiveness will be investigate and receiving~     operative characteristic (ROC) curve will be built. The correlation between the variation of~     stroke volume during abdominal compression and during the fluid load will be studied. Other~     parameters such as arterial pressure and heart rate will also be investigated.~   "
42131|NCT02505633|"~     Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized~     regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in~     which the neural cluster formed by the trunks or divisions of the brachial plexus is~     situated superolateral to the subclavian artery (SA).~      In many approaches, corner pocket approach [deposit local anesthetic (LA) at the~     intersection of the SA, neural cluster, and the first rib] and cluster approach (direct~     deposit LA into the neural cluster after penetration of the sheath of brachial plexus) has~     been well known methods. And single or multiple injection techniques has been used with the~     above approaches.~   "
42132|NCT02505620|"~     Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway~     obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic~     decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient~     rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold~     standard therapy is continuous positive airway pressure ventilation during sleep. However,~     the success depends strongly to the patient´s compliance. Surgical treatment is an~     alternative option, which could be considered if clinical success failed. A comparison of~     the cognitive function of both therapies is not yet analyzed. The study addresses the~     question which of this treatment options is favorable regarding cognitive function and~     outcome.~   "
42175|NCT02504918|"~     Background:~      - The disease malaria can cause very serious health problems. Researchers want to see if~     malaria affects the way T cells and vaccines work in the body. If it does, they may need to~     give malaria treatments before vaccines. They want to check the T cells in children who do~     or do not get antimalarial treatment.~      Objectives:~      - To study the effect of blood stage malaria on T cell suppression and vaccine responses. To~     describe markers of T cell suppression in children who do or do not receive antimalarial~     treatment.~      Eligibility:~      - Children ages 12 59 months living near Ouelessebougou in Mali. They must have no serious~     illness.~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Some participants will get a course of antimalarial tablets. Some will not. This will~          be decided at random.~        -  Participants will have monthly visits for up to a year. They will have blood tests at~          each visit.~   "
42133|NCT02505607|"~     Overactive bladder (OAB) is a common, chronic condition, characterized by urinary urgency,~     with or without urge incontinence, usually with frequency and nocturia. Treatment adherence~     is a major barrier to management of OAB and drug continuation is poor. Many factors may play~     a role in non-adherence to medication management of OAB including drug cost, side effects,~     and a lack of understanding of the disease and treatment process.Studies show that recall of~     disease information and treatment is often suboptimal. Literature shows that providing~     written materials is an efficacious way to aid in recall. Based on known poor adherence to~     OAB medication treatment and the clear role patient education methods have on patient~     information recall, the investigators believe that improvement of participant education~     through use of a OAB care plan will improve participant understanding and treatment~     adherence.~      Through this randomized trial, the investigators plan to evaluate whether implementation of~     a OAB Care Plan improves understanding of disease and treatment options, treatment success,~     and satisfaction.~      This is a prospective, randomized, controlled study of OAB counseling in new patients~     presenting to the Urogynecology offices of Hartford Hospital. All new patients with a~     diagnosis of OAB will be offered participation. All consenting participants will be~     randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the~     Standard Care group, participants will be counseled as the physician routinely counsels~     patients about OAB, in the Care Plan group, participants will be counseled a printed~     Overactive Bladder Plan of Care information sheet. At the end of the visit, the~     participant will complete a Baseline Survey. The Baseline Survey includes basic demographic~     information, a physician satisfaction survey, and a OAB knowledge survey. The participant~     will return for follow up as directed by the physician.~      At the follow up visit, participants in both groups will complete a Followup Survey. The~     Followup Survey will be completed before the participant sees the physician. The Followup~     Survey assesses OAB knowledge.~      Eight months after the baseline visit, each participant's chart will be reviewed for final~     data collection. If a participant progresses to a treatment method where she is satisfied~     and would like to remain, this will be documented.~   "
42134|NCT02505594|"~     Obstructive sleep apnea (OSA) is a common disorder with major cardiovascular sequelae. A~     recent study confirmed that OSA is associated with impaired exercise capacity and increasing~     OSA severity predicts worsening exercise capacity, which is a marker of potential increased~     cardiovascular risk. However, potential mechanisms of decreased exercise capacity caused by~     OSA remain unclear. Several pathophysiologic mechanisms of OSA have been proposed and~     investigators hypothesize that endothelial dysfunction leading to exercise-induced right~     ventricular dysfunction and associated pulmonary hypertension is the potential mechanism for~     impaired exercise capacity in OSA.~   "
42135|NCT02505438|"~     Maintaining muscle mass and function is important in healthy ageing to maintain quality of~     life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by~     ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism~     regulating muscle mass as we age. In this project the investigators aim to determine these~     mechanisms using a new technique of heavy water ingestion, this allows measurement of~     multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long~     periods (6 weeks) as people go about their normal everyday activities. The investigators~     also aim to determine the influence of resistance exercise training on older muscle, as well~     as differences between men and women in muscle responses to exercise and nutrition HMB~     (beta-hydroxy-beta-methylbutyrate).~   "
42136|NCT02505425|"~     Advanced heart failure affects nearly 6 million Americans, and less is known about how this~     illness affects the 80% of heart failure patients who are 65 years and older because~     research tends to focus on younger patients. Older patients with heart failure and their~     family caregivers, rarely have access to palliative supportive care services because the~     disease is unpredictable and palliative treatment may not be provided until after other~     medical treatments have been tried. Investigators are studying whether palliative care~     provided when advanced heart failure patients are still well will result in better quality~     of life, mood and less symptom distress compared to usual or standard heart failure care.~      Specific Aims and Hypotheses:~      Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure~     patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom~     burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16~     weeks after baseline.~      • Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower~     symptom burden and resource use at 8 and 16 weeks after baseline compared with those~     receiving usual HF care.~      Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL,~     mood (anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16~     weeks after baseline.~      • Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported~     health, and lower caregiver burden at 8 and 16 weeks after baseline.~   "
42137|NCT02505412|"~     Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac~     screening needed?~   "
42138|NCT02505399|"~     Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly~     calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into~     microscopic particulates to allow less hazardous coronary revascularization and stenting.~     The main drawback associated with the procedure is the subsequent enhancement of platelet~     aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic~     fragments. In order to limit these complications, a double antiplatelet therapy is required~     (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the~     protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new~     antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is~     currently indicated to reduce risk of cardiovascular events in patients hospitalized for~     coronary revascularization after an acute coronary syndrome. Ticagrelor has never been~     evaluated so far in stable coronary patients treated with rotational atherectomy prior to~     angioplasty.~   "
42145|NCT02505308|"~     Defects in insulin secretion are central to the pathogenesis of type 2 diabetes (T2D) but~     the molecular basis and physiological consequences of those defects are poorly understood,~     impeding efforts to develop novel therapeutic approaches. Key questions remain unanswered,~     such as the extent to which T2D-associated islet dysfunction reflects endogenous defects in~     beta-cell mass or function, as opposed to disruption of external factors impinging on the~     beta-cells, such as incretins.~      Recently the investigators have identified several genetic variations (DNA changes)~     associated with the production and processing of insulin in non-diabetic individuals and now~     aim to explore in more detail the role of these genetic variations. Utilising a recruit by~     genotype approach, they will identify individuals with and without genetic variants of~     interest from existing databases of research volunteers. The investigators will collect~     detailed medical history and measurements, fasted and stimulated blood samples for the~     profiling of insulin-related hormones and metabolites. The resulting genetic and non-genetic~     data will be used to improve understanding of the role of genetic variation on insulin~     secretion and sensitivity defects that lead to the development of T2D.~   "
42237|NCT02504112|"~     The objective of the observational study is to assess the positioning of customized guides~     designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary~     total knee arthroplasty.~   "
42139|NCT02505386|"~     In geriatric departments, physicians are faced with two difficulties, first the increasing~     number of infections caused by multiresistant bacteria, especially extended spectrum~     β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access~     frequently encountered in elderly population. Giving antibiotics subcutaneously would be an~     interesting alternative, all the more as intramuscular injection is contraindicated in case~     the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC)~     administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially~     in the treatment of ESBL infection. Its subcutaneously administration has been tested in~     several studies in Intensive Care Units (ICU) and internal medicine wards with promising~     results regarding clinical and pharmacokinetics data.~      An alternative to the IV Ertapenem administration is needed because of poor venous access~     and behavioural abnormalities commonly present in infected elderly population. Ertapenem is~     currently SC administrated in geriatric departments if no other option is available.~     Moreover elderly patients often present several comorbdities, polymedication, renal~     insufficiency, cachexia which may disturb antibiotics pharmacokinetics.~      The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration~     in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics~     (T%>MIC) and descriptive data of occurrence of adverse effects and evolution of signs of~     infection.~   "
42140|NCT02505373|"~     Objective~      Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence~     of the effectiveness of follow-up treatments for these patients is limited. The authors~     evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a~     novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP~     consists of three sessions followed by regular letters for 24 months.~      Method~      In this treatment study, 120 patients were randomly assigned to either the ASSIP~     intervention or a control group that received a one-session clinical assessment. Both groups~     received in- and outpatient treatment as usual. Study participants also completed a set of~     psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.~   "
42141|NCT02505360|"~     We seek to compare biochemically and histologically the nasal cartilage and ear in the~     newborn cleft lip and slot carrier in order to improve the quality of care and patient~     comfort after surgery of cheilorhinoplasty which is the primary treatment slots .~      The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by~     immunohistochemistry and study of mRNA and then they are compared according to the type of~     cartilage.~      This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip~     and operated in the neonatal period.~      Given the difficulty and constraint of time it takes to reach the 20 subjects of our study ,~     we will also add to our population the stillborn babies before 25SA and newborns who die~     before the age of 28 days and having had an autopsy.~   "
42142|NCT02505347|"~     Distal biceps ruptures occur most commonly among young males in their third and fourth~     decade of life. These injuries are becoming more common, however, as the aging population is~     remaining active through sport or labour demands. Distal biceps tears or ruptures follow a~     heavy eccentric load being placed on a shortened or flexed muscle, and often require~     surgical repair. Functionally, distal biceps injuries cause impairment as this portion of~     the muscle is largely responsible for supination and flexion at the elbow. Currently there~     is no consensus regarding post-operative immobilization protocols, and little evidence is~     available regarding timeframe for early return to functional activities. Existing evidence~     on functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small~     sample sizes, and no known RCTs exist comparing early mobilization to immobilization on~     functional return. Reported timeframes for immobilization range from early controlled motion~     on day 1 post-operatively to complete immobilization for 6 weeks.~      The primary study goal is to determine the effect of immobilization compared to unrestricted~     mobility post DBTR on early functional return to activities. It has been previously reported~     that those with DBTR related to a workers compensation injury returned to full duties in~     3.95 months, while those with a non-workers compensation related injury returned to full~     work duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013~     and 2014. Early mobilization of these repairs may allow an earlier return to modified and~     full work duties, thereby improving the functional quality of life of the individual as well~     as reducing the overall cost of disability payments.~      This study will assess the 1) time to return to pre-injury work level and 2) time to return~     to modified duties among those who have no movement restriction post-repair and those who~     are splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will~     strength, range of motion (ROM) and quality of life. These findings will assist in~     developing a standardized protocol for immobilization to optimize functional and clinical~     outcomes while expediting return to work.~   "
42143|NCT02505334|"~     This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety~     of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2~     diabetes mellitus.~   "
42144|NCT02505321|"~     The adipose (fat) cells under the skin are where individuals store excess fat. The more~     excess fat they have, the more strain they put on these cells which then get bigger and~     don't work as well as they should. Having some fat under the skin is important. People who~     have a genetic defect which results in them having almost no fat under their skin have a~     very high risk of a condition called insulin resistance (where the body does not respond as~     well to insulin and blood sugar levels rise). This can lead to diabetes and heart disease~     despite them not being overweight.~      Scientists have only recently started to understand the importance of fat in insulin~     resistance and how people unable to store fat very well can have insulin resistance despite~     not being obese. The investigators have also recently discovered that small changes in a~     person's genetic code (their body's instruction manual) may also affect their ability to~     store fat and would like to explore this in more detail. To do this, they will recruit~     volunteers from the Exeter 10,000 study who gave permission to contact them about further~     research. The investigators will collect detailed body size measures and blood samples taken~     before and after a special drink that is high in fat (similar to a thick milk shake), then~     compare the results between people with and without the particular genetic changes of~     interest.~      Knowing more about these genetic changes and how fat cells work could help to improve~     understanding about why some people develop diabetes and heart disease despite a relatively~     normal BMI.~   "
42146|NCT02505295|"~     Selenium is a trace element essential to human health.Selenium protection against cellular~     damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is~     associated with the generation of oxygen free radicals resulting in a condition of oxidative~     stress. Supplementing stroke patients with antioxidant nutrients may improve survival.~   "
42238|NCT02504099|"~     The purpose of this study is to evaluate the safety and efficacy of~     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV)~     coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with~     genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular~     Carcinoma with compensated cirrhosis.~   "
42147|NCT02505282|"~     Postural hypotension is common in older people, leading to falls, decline in function, and~     dependence. Available treatments have limited efficacy and tolerability; novel approaches to~     treatment are therefore needed. Decreased vascular health, stiffening of the arteries and~     consequent decreased vascular reactivity are thought to contribute to postural hypotension~     and are therefore therapeutic targets.~      Recent trial evidence has suggested that vitamin K may exert beneficial effects on vascular~     health particularly in respect to inhibiting calcification. Calcification increases vascular~     stiffness, decreases compliance and thus decreases the ability of blood vessels to~     autoregulate blood pressure and flow - which could contribute to postural drops in blood~     pressure. Worsened vascular health could also impact adversely on baroceptor function, which~     is needed for blood pressure autoregulation and which is disrupted in patients with~     orthostatic hypotension.~      Vitamin K intake is below recommended daily intake in 60% of adults in the UK. In animals,~     vitamin K supplementation may be able to reverse calcification of arteries, and in humans~     Vitamin K has been shown to arrest decline in carotid artery elasticity compared to placebo.~     High levels of circulating vitamin K were also associated with lower levels of CRP in the~     Framingham cohort, suggesting a possible role in the suppression of chronic inflammation~     that is known to accompany vascular disease. The recent ECKO study suggested that vitamin K~     may reduce falls and fractures; an intriguing question that follows on from this is whether~     this could be due to beneficial effects on vascular health and postural hypotension, leading~     to less dizziness and reduced falls.~      This cross-sectional comparative study aims to find whether there is a difference in the~     vitamin K status of patients with postural hypotension compared to those without postural~     hypotension and whether differences in vitamin K status are associated with other markers of~     vascular function in patients with and without postural hypotension. This could potentially~     lead to new treatments for the condition for which there is currently little of proven~     benefit.~   "
42148|NCT02505269|"~     Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD~     chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart~     injury, and others. This trial eliminates radiation therapy and reduces intensity of~     chemotherapy by incorporating the highly active FDA-approved targeted therapy brentuximab~     vedotin, an antibody-drug conjugate specifically against the lymphoma cells, combined with~     the standard chemotherapy drugs Adriamycin and Dacarbazine (AD).~   "
42149|NCT02505256|"~     Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline~     for the treatment of this disease. This study was launched to investigate into the problem~     that which patients should be diagnosed as hyperplasia of mammary glands and which patients~     should be treated.~   "
42150|NCT02505243|"~     The aim of this study is to evaluate RBV plasma concentrations when used in combination with~     newly developed DAA combinations. If possible, its correlations with SVR rates and incidence~     of anaemia will be assessed in HCV-patients.~   "
42151|NCT02505230|"~     This study will investigate the energy consumed from an entree with high- or low-volume~     vegetables incorporated into the entree or served along side of the entree, in normal weight~     adults.~   "
42152|NCT02505217|"~     Treatment of patients who have had a heart attack with drugs that prevent formation of blood~     clots has been shown to reduce the patient's risk of subsequent cardiovascular events such~     as heart attack, stroke, and death. Because new drugs have increased treatment options, the~     development of tests that can guide treatment should improve treatment selection and further~     reduce the risk of cardiovascular events as well as bleeding. This study is designed to~     assess the value of new tests. It is a prospective study that will enroll patients who have~     had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day~     after their heart attack) and a second time 6 months later during an ambulatory clinical~     visit. Investigators will perform biochemical tests on the blood that assess the likelihood~     of making blood clots. One tablespoon of blood will be taken at each time. Taking this~     amount of blood poses no risk to the participant. Investigators will ask the participant~     whether they have had bleeding or cardiovascular events during the initial evaluation, the~     ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment.~     During their 1 year of participation, investigators will review medical records and record~     information in a manner that protects the identity of all participants. We hypothesize that~     the biochemical test results will be similar at baseline and 6 month follow-up and that~     these biochemical tests will identify patients at greater risk of cardiovascular events and~     bleeding. Treatment of participants will not be altered by their participation in this~     study.~   "
42153|NCT02505204|"~     Paravertebral block (PVB) combined with light intravenous sedation was associated with a~     short hospital stay, less post-operative nausea and vomiting and reduced analgesic~     consumption compared to general anesthesia for ventral hernia repair. Given the~     effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the~     effect of PVB with versus without clonidine in elderly patients.~      Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the~     sealed envelope technique. Group one will receive PVB with clonidine while group 2 will~     receive PVB with placebo.~   "
42154|NCT02505191|"~     A pilot phase I, randomised, open mono-center, two parallel group clinical trial~     investigating the pharmacokinetics of a prolonged-release formulation in comparison to an~     immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers~     under fasting condition.~   "
42155|NCT02505178|"~     This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy~     intervention for the treatment of late life depression (LLD). Participants diagnosed with~     LLD will participate in six sessions of Problem Solving Therapy, a form of talk-therapy,~     over a period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome~     measure is depression severity and will be measured throughout the study at weeks 0, 4, and~     8. the secondary outcome measure is quality of life and will be measured at week 0~     (pre-intervention) and week 12.~   "
42156|NCT02505165|"~     The purpose of this study is to test the efficacy of a clinic-based intervention designed to~     reduce illness uncertainty for parents of children who have been recently diagnosed with~     cancer.~   "
42157|NCT02505152|"~     To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for~     treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.~   "
42158|NCT02505139|"~     A circulating tumor cell (CTC) count is an established prognostic factor in some~     malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and~     outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown.~     Through the observational prospective clinical trial, sensitivity, specificity, positive and~     negative predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the~     value of CTC in outcome prediction of mNPC patients will be uncovered.~   "
42159|NCT02505126|"~     The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol~     consumption within the 24 weeks following the treatment in non-abstinent patients with~     alcohol use disorders versus placebo.~   "
42161|NCT02505100|"~     The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy~     complicated by preterm delivery in 5-10% of cases in developed countries. Psychological~     stress that encompasses anxiety and anxiety resounding including sleep quality can be a work~     of preacher and premature delivery.~      Preterm birth before 37 has an impact on the survival and health of the newborn. It is the~     leading cause of mortality and obstetric complications. It has a cost both for the newborn,~     the term parturient health but also the financial cost by the management before delivery and~     the consequences of a premature birth.~      The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The~     hospitalization and invasive procedures contribute to increasing stress. It therefore seems~     necessary to seek to diversify and master reputable techniques for their effectiveness on~     mastering stress and improving sleep quality as hypnosis and feel relaxing.~      Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression.~     It also reduces preoperative anxiety and during induction of anesthesia, as well as~     behavioral disorders during the first postoperative week. Hypnosis can play an important~     role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with~     drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.~      The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on~     the anti-stress hormones and plays a role in reducing pain during childbirth.~      Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in~     case of MAP. The published data relate to a small number of patients and a low level of~     evidence. Although there seems promising results, prospective studies are needed to conclude~     its effectiveness in improving the stress, pain or other parameters.~      Health workers trained in these techniques could observe during their production improved~     sleep disorders, stress, better communication between doctor and patient. Moreover, these~     treatments could induce an improvement in the overall care of patients, and therefore have~     an impact on the continuation of pregnancy.~      These findings are based on these hypothesis. There is a clinical gain the contribution of~     hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This~     would, among other improvements in sleep disorders and stress, decrease pain, and acting on~     the extension of the term of pregnancy in women followed by these techniques and a decrease~     in hospitalizations of newborns premature neonatology and neonatal intensive care units.~   "
42162|NCT02505087|"~     The objective of this study is to determine whether the administration of N-acetylcysteine~     (NAC) improves oxidative stress. To determine this, the study will assess the impact of oral~     treatment on the balance between reduced and oxidized form of glutathione in erythrocytes of~     peripheral blood.~   "
42163|NCT02505074|"~     The Melody valve has historically been used for pulmonary valve replacements; however it has~     been more recently used in the mitral and tricuspid positions. This multi-center,~     retrospective, observational study will review the durability of the Melody valve inserted~     into the mitral or tricuspid positions.~      Patients who have undergone Melody valve insertion into either the mitral or tricuspid~     positions prior to December, 2014 will be eligible for the study. Basic de-identified~     patient demographics will be collected as well as select clinical data. Ventricular function~     and valvar function of the affected valve will be retrospectively reviewed both prior to~     surgery and following, as well as review of operative data. The investigators will also~     review the most recent follow up data and any subsequent re-interventions on the Melody~     valve. Data from all sites will be entered into an external REDCap database, using only~     de-identified data.~   "
42164|NCT02505061|"~     The four purposes of this study are: 1) to examine the feasibility of providing children~     with disabilities to explore the environment with a modified ride-on car; 2) to quantify~     whether children with disabilities are able to have more social interactions with a ride-on~     car; 3) to examine the progression of socialization during the intervention and follow-up~     phases to determine which factors might influence the learning curve; 4) to compare the~     effectiveness of using the modified toy cars through the hospital-based program and regular~     therapy program after intervention and follow-up phases to determine the critical factors on~     increasing independent mobility and socialization, including motivation, treatment executor,~     treatment environment and play programs. It can provide guidelines for the future~     intervention.~      Independent mobility is believed to be essential for perceptual-motor, cognition, language~     and social skill development. It is important to increase the independent mobility in~     children with disabilities and further enhance their development, especially motor and~     socialization. Assistive and power mobility devices allow children with disabilities to move~     independently within their environment and may increase the opportunities to explore and~     interact with people and environment . However, issues to consider before prescribing an~     assistive device include factors such as age, accessibly to community environments, cost,~     social acceptance of the device and the adaptability of the device to growth. This study is~     to use the customized, modified ride-on toy cars, to enhance the independent mobility,~     exploration and socialization through low-cost, family-centered approach. It will also~     improve family's understanding of children's capabilities, which improve their development.~     Investigators will recruit 60 children with who are between 1 to 3 years old and diagnosed~     as motor delay (>1.5 sd). They will be randomly assigned to one of the following two groups:~     hospital-based program group and regular therapy group.~      The whole study duration will be 18 weeks, including 9-week intervention and 9-week~     follow-up; the total amount of treatment will be equal for two groups. The hospital-based~     program will be administered by the therapist and include 120 minutes/per session, 2~     sessions/per week. In addition, the research team will visit the hospital once/per week to~     provide assessments. The regular therapy group will continue their regular therapy without~     any additional car driving training. The research team will visit them once/per week for the~     assessments. The assessments include behavior coding from the videotapes and the clinical~     assessments. The findings of this study will help to understand the feasibility and~     effectiveness of using the low-tech modified toy cars on advancing children's mobility and~     socialization. They can be used in the clinics and are a low cost alternative or addition to~     other mobility devices. They may provide a novel therapeutic tool to improve mobility,~     socialization and development.~   "
42165|NCT02505048|"~     The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in~     progressing breast cancer patients and who are carrying a BCRAness profile defined by~     genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline~     mutation.~   "
42166|NCT02505035|"~     This is a large pragmatic, randomized controlled trial to test the real-world effectiveness~     of inpatient palliative care consultative services in improving a number of patient- and~     family-centered processes and outcomes of care among seriously ill hospitalized patients.~     The investigators hypothesize that improved patient-centered outcomes can be achieved~     without higher costs by simply changing the default option for inpatient palliative care~     consultation for eligible patients from an opt-in to an opt-out system. To test this~     hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same~     electronic health record within Ascension Health, the largest non-profit health system in~     the U.S.~   "
42167|NCT02505022|"~     During this study the investigators will 1) collect measures of social cognition and social~     functioning in adolescents and young adults who are experiencing early symptoms of a major~     mental disorder; and 2) evaluate the predictive value and utility of a new role functioning~     assessment measure for individuals experiencing changes in their lives after an index~     episode of mental illness. This will happen in the context of providing treatment-as-usual~     to individuals who arrive seeking help with the early phases of mental illness.~   "
42190|NCT02504723|"~     Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal~     bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective~     β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding~     is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to~     gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.~   "
42191|NCT02504710|"~     This study will try to analyze the effect of the real-time kinematic feedback (KRTF) to~     learn manual therapy on peripherical joints comparing the results with the traditional~     teaching method.~   "
42276|NCT02503605|"~     Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another~     step in simplifying fertility treatments, making them easier to manage and more accessible~     to patients. Taking in mind these arguments ,the study is proposed for determining~     equivalence in terms of biological effectiveness of an ovarian stimulation protocol with~     biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.~   "
42168|NCT02505009|"~     Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but~     only about 30-40% remain sustained response 1-3 years after discontinued therapy. The~     investigators will try to improve the sustained response rate by given a course of HBV~     vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir~     therapy.~      Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are~     suppressed during entecavir or tenofovir therapy.~      Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30~     months will be invited to this study. The case group will receive 5 Engerix-B injections~     during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated~     group: 75 cases will be enrolled to receive Engerix-B injection and compared with~     histological non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients~     will be randomized into case (vaccine) and control group according to age, gender,~     pretreatment HBV DNA level.~      Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir~     therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir~     or tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th~     month [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be~     discontinued after completed therapy.~      Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative~     HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy.~      Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL~     after discontinued nucleos(t)ide analogues therapy will be considered to have sustained~     response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously~     without further therapy will be defined as delayed response. Patients with persistent HBV~     DNA greater than 1*100000 cps/mL will be considered to have non-sustained response.~      Study duration: The enrollment will be completed in one year and keep on observation for~     additional 2 years.~      Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may~     decrease the HBV relapse rate at 1 and 2 year after completed therapy.~   "
42169|NCT02504996|"~     Siatalgia is one of the main symptoms related to emergency department presentations.~     Patients with sciatalgia are seeking for immediate pain relief and little known regarding~     the pain management of these patients in emergency department. This study aim to trial the~     effect of intravenous paracetamol and morphine in patients presented with sciatalgia to~     emergency department.~   "
42170|NCT02504983|"~     Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to~     exert a beneficial effective on time-to-tumor-progression (TTP) in patients with~     unresectable hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect~     varies among studies conducted in different areas of the world. The objectives of this study~     are (1) to understand whether GALNT14 TT genotype patients respond better than do GALNT14~     non-TT genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT~     genotype patients can benefit from TACE plus sorafenib (Nexavar) combination therapy.~     Patients enrolled will be stratified by GALNT14 genotyping. The GALNT14 non-TT patients~     were then randomized into two subgroups to evaluate the safety, tolerability and efficacy of~     TACE plus sorafenib therapy.~      The primary endpoint of this study is the efficacy of TACE with or without sorafenib~     combination therapy evaluated by complete remission (CR).~      The secondary endpoints are:~        1. Time to partial or complete response (PR + CR).~        2. Time-to-tumor-progression (TTP) and the progression free survival (PFS).~        3. Overall survival (OS).~        4. Safety and tolerability of TACE plus sorafenib therapy.~   "
42171|NCT02504970|"~     The Anesthesia Quality Institute (AQI) is home to the National Anesthesia Clinical Outcomes~     Registry (NACOR), a data warehouse that has been designated as a Qualified Clinical Data~     Registry (QCDR) by the Centers for Medicare and Medicaid Services (CMS) for Physician~     Quality Reporting System (PQRS) reporting. With 20 million cases and growing, Anesthesia~     Quality Institute's clinical data provides an evidence-based rational that informs treatment~     choices and helps control treatment costs.~      National Anesthesia Clinical Outcomes Registry is intended for all anesthesia providers~     caring for patients. The registry provides participating providers with:~      Custom continuous performance monitors Performance gap analysis and patient outlier~     identification Access to improvement interventions to close performance gaps including~     patient care management tools, targeted education, resources and other evidence based~     interventions Registry and peer-to-peer benchmarks~   "
42172|NCT02504957|"~     Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The~     aim of this study is to assess the feasibility and safety of this technique in the context~     of a nationwide retrospective analysis.~   "
42173|NCT02504944|"~     The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye~     drops in treating preterm newborns with a precocious stage of retinopathy of prematurity~     (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive~     propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no~     more than 90 days.~      Propranolol concentrations will be measured on dried blood spots at the steady state (10th~     day). Cardiovascular and respiratory parameters will be continuously monitored. Blood~     samplings checking metabolic, renal and liver functions will be performed periodically, as~     well as cardiac function, in order to verify the treatment safety. Serial ophthalmological~     evaluations will be planned to monitor the efficacy of the treatment, the ROP progression~     and the possible complications.~   "
42174|NCT02504931|"~     The investigators propose to conduct a clinical trial to evaluate sertraline treatment~     efficacy in a large sample of military veterans with a dual diagnosis of PTSD and Alcohol~     Use Disorder who are receiving Cognitive and Behavioral Therapy as part of the VA-system's~     new dual diagnosis program. The study is designed as an efficacy trial of sertraline used as~     an adjunct to Cognitive Behavioral Therapy (CBT) in the treatment of PTSD/Alcohol dual~     diagnosis. There are two outcomes of interest, namely PTSD symptom improvement and also~     decreased alcohol consumption. The investigators are interested to know whether or not~     sertraline is superior to placebo in improving the symptoms of either one or both of these~     two disorders. Even though sertraline is a treatment of choice for PTSD, the investigators~     expect that the comorbid condition of alcohol dependence will complicate the treatment of~     PTSD and that the clustered subgroups will show differential treatment response with~     sertraline. The primary objective of the present study is to identify subgroups of alcohol~     dependent persons with PTSD who will either benefit or not benefit from treatment with~     SSRI's. The proposed study will enroll veterans with PTSD and dually-diagnosed alcohol~     dependence in a 12-week treatment providing sertraline vs. placebo medication as an adjunct~     to manualized CBT and will specifically test the hypothesis that subtypes of alcohol~     dependence can be used to predict which patients respond well and which subgroup responds~     poorly to SSRI treatment.~   "
42285|NCT02503488|"~     The purpose of the current study is to examine the psychological well-being of youth within~     the context of participation in political violence during the 2015 election period in~     Burundi. In detail, the investigators are interested in fostering improved outcomes in a~     peace-building initiative aimed at youth in Burundi by reducing the mental health-related~     stress of the initiative's most severely affected participants. In addition, the~     investigators are interested in learning more about the youth experience of involvement in~     the Burundian political system in an effort to understand the links between youth engagement~     in political violence and past experiences of traumatic events.~   "
42176|NCT02504905|"~     Background:~      - People with dystonia have muscle contractions they can t control. These cause slow,~     repeated motions or abnormal postures. People with dystonia have abnormalities in certain~     parts of the brain. Researchers want to study the activity of two different brain areas in~     people with writer s cramp and cervical dystonia.~      Objective:~      - To compare brain activity in people with dystonia to that in healthy people.~      Eligibility:~        -  Right-handed people ages of 18 60 with cervical dystonia or writer s cramp.~        -  Healthy volunteers the same ages.~      Design:~        -  Participants will be screened with a physical exam. They will answer questions about~          being right- or left-handed.~        -  At study visit 1, participants will:<TAB>~        -  Have a neurological exam.~        -  Answer questions about how their disease impacts their daily activities.~        -  Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a~          table that can slide <TAB>in and out of a metal cylinder. This is surrounded by a~          strong magnetic field.~        -  Do 2 simple computer tasks.~        -  At study visit 2:~        -  Participants will have transcranial magnetic stimulations (TMS) at 2 places on the~          head. Two wire <TAB>coils will be held on the scalp. A brief electrical current creates~          a magnetic pulse that affects brain <TAB>activity. Muscles of the face, arm, or leg~          might twitch. Participants may have to tense certain muscles or do simple tasks during~          TMS. They may be asked to rate any discomfort caused by TMS.~        -  Muscle activity in the right hand will be recorded by electrodes stuck to the skin of~          that hand.~   "
42177|NCT02504892|"~     Background:~      - Research has shown that the drug everolimus can stop cancer cells from growing. It is~     approved for people with advanced kidney cancer. Researchers want to see if it also helps~     people with two other types of kidney cancer.~      Objective:~      - To see if everolimus is safe and effective in people with Birt-Hogg-Dube Syndrome~     (BHD)-associated kidney cancer or sporadic (nonfamilial) chromophobe renal cancer.~      Eligibility:~      - People ages 18 and over with BHD-associated kidney cancer or advanced sporadic chromophobe~     renal cancer.~      Design:~        -  Participants will be screened with:~        -  Medical history, physical exam, and blood and urine tests.~        -  Computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. They will lie~          in a machine that takes pictures of their chest/abdomen/pelvis.~        -  They may also be screened with:~        -  Another scan, of the brain or neck.~        -  Bone scan.~        -  Positron emission tomography scan with fludeoxyglucose (FDG-PET).~        -  Heart and lung tests.~        -  Tests for hepatitis.~        -  Participants will take a tablet once a day by mouth for up to a year. They will keep a~          diary of when they take the tablet and any symptoms.~        -  During the study, participants will have physical exams and urine and blood tests. They~          will have scans of the chest/abdomen/pelvis. They may have FDG-PET and bone scans.~        -  Participants will have tests for hepatitis and may have a tumor sample taken.~        -  Participants will have a follow-up visit 4 5 weeks finishing taking the drug. They will~          have a physical exam and blood tests. They may have scans and/or hepatitis tests.~        -  Participants will be called about every 3 6 months after the study ends to see how they~          are doing~   "
42178|NCT02504879|"~     Background:~      - The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can~     affect bones, joints, and muscles. Researchers want to learn more about the disease and how~     it progresses.~      Objective:~      -To see what happens to people with melorheostosis over time and understand the causes of~     the disease.~      Eligibility:~        -  People 18 and over with melorheostosis.~        -  Their unaffected relatives.~      Design:~        -  All participants will have a medical history and physical exam.~        -  Participants who are relatives will give samples of blood or cheek cells.~        -  Other participants will be in the study for about 1 week.~        -  They will have blood and urine collected.~        -  Strength, walking, and range of motion will be measured.~        -  Participants may also have~        -  X-rays and scans.~        -  A pain and neurological evaluation.~        -  Their skin evaluated by a dermatologist.~        -  A small sample of bone taken.~        -  Nerve conduction studies. Small electrodes with to wires will be put on the skin. A~          metal probe will give a small electrical shock.~        -  Electromyography. A thin needle will be placed into the muscles.~        -  An ultrasound, which uses sound waves to examine the muscles and nerves. An ultrasound~          probe will be placed over the skin.~        -  A bone scan. They will get a small amount of radioactive fluid through a needle in an~          arm vein. This fluid travels to the bones. The bones will be photographed in a machine.~        -  Bone Densitometry, a low-level x-ray.~        -  Photographs taken.~        -  A small circle of skin removed with a surgical instrument.~        -  Questionnaires about their quality of life.~        -  Participants will be asked to return about every 2 years. At these visits, participants~          may have blood and urine tests and x-rays.~   "
42179|NCT02504866|"~     Background:~      - Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking~     and emotions. Exercise can improve these things in people with other brain damage.~     Researchers want to look at the effect of exercise on these things in people with TBI.~      Objectives:~      - To study how head injuries affect the brain. To study if exercise can help some symptoms~     in people with TBI. These include problems thinking, balancing, and moving, and depression~     or anxiety.~      Eligibility:~        -  People age between 18 and 79 :~        -  Had a non-penetrating TBI at least 12 months ago.~        -  Are physically inactive, but can stand and walk without help.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They may have a balance test.~        -  Participants will be assigned to a high-intensity or a lower-intensity exercise~          program.~        -  The study is 6 months long. There will be 3 months with exercise on an elliptical~          machine and 3 months without exercise.~        -  Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for~          3 months.~        -  Participants will also have 3 outpatient testing visits lasting approximately 8 hours,~          once every 3 months. This visit will include:~        -  Blood tests~        -  Tests for memory, attention, and thinking~        -  Tests of walking and balance~        -  Questionnaires~        -  An MRI: they will lie in a machine that takes pictures of their brain, while breathing~          regular air and air with more carbon dioxide~        -  Test of physical fitness.~   "
42192|NCT02504697|"~     The goal of this project is to improve lung cancer screening in high-risk individuals by~     identifying biomarkers of preclinical disease and disease risk that are measured in~     minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer~     diagnosis as well as new biomarkers discovered specifically in this clinical setting will be~     examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung~     cancer prior to the appearance of concerning symptoms could increase the utility of lung~     cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials.~     Achieving these goals would improve the detection and treatment of early stage and incipient~     lung cancer, while restricting the risk of these procedures to those individuals who~     currently exhibit the early molecular warning signs of impending disease.~   "
42180|NCT02504853|"~     Background:~      - About 15 million Americans have a food allergy. Because there are no cures or effective~     prevention or treatment for food allergies, researchers want to learn more about them.~      Objective:~      - To learn more about the causes and effects of food allergy and related conditions.~      Eligibility:~        -  People ages 2 99 who have food allergy and/or a related genetic or other condition~        -  Their relatives~        -  Healthy relatives and volunteers~      Design:~        -  Participants will have at least 3 visits over 1 2 years, and then once a year for up to~          12 years. Each may last a day or longer.~        -  Participants will be screened with medical history, physical exam, and questionnaires.~        -  Participants may have the following:~        -  Blood tests~        -  Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is~          scratched under each drop.~        -  Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and~          returned through a needle in the other arm.~        -  X-rays~        -  Esophageal string test: One end of a string is taped to the cheek and the other end is~          packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in~          for at least 1 hour.~        -  EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.~        -  Tiny biopsies of skin~        -  Photographs of the body~        -  Collection of cells through:~        -  Swab of nose, inside of cheek, or skin~        -  Gentle skin scrape~        -  Tape stripping: piece of tape is put on the skin and pulled off.~   "
42181|NCT02504840|"~     Background:~      - Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor~     neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI~     pictures are taken. They also want to learn more about using newer MRIs with stronger~     magnets to get better pictures than standard MRIs provide.~      Objectives:~      - To collect data that will help researchers better understand MS and related diseases.~      Eligibility:~        -  Adults 18 and older with MS or MRI findings that appear similar to MS, or with other~          neurological diseases that may look or act like MS.~        -  Healthy adult volunteers.~      Design:~        -  Participants will be screened with a review of their medical records.~        -  Participants will have a baseline visit. It will include a physical exam, medical~          history, and neurological exam. They may have blood tests.~        -  The study will last indefinitely.~        -  Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle~          will be used to guide a thin plastic tube into an arm vein.~        -  Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a~          needle inserted between back bones will remove fluid.~        -  Participants may give saliva samples and have an eye exam.~        -  Participants may have evoked potential tests. These measure how the nervous system~          responds to different types of stimulation. Participants may sit in front of a TV and~          watch pictures on the screen. Or they may wear earphones that make a clicking noise or~          static. Or they may get a small electrical shock that may tingle and cause a hand or~          foot twitch.~        -  Participants may have tests of strength, spasticity, sensations, balance, and/or~          walking.~   "
42182|NCT02504827|"~     The purpose of this research study is to characterize the pharmacokinetics of intravenous~     ceftazidime/avibactam in patients with Cystic Fibrosis.~   "
42183|NCT02504814|"~     The study explores the changes in pressure, volume and in hypercapnia in patients with COPD.~     The investigators will use different application forms.~   "
42184|NCT02504801|"~     To test the hypothesis that nebulized Pulmicort Respules could reduce post operation~     pulmonary complication incidence in primary lung cancer patients with COPD. Compare~     post-operation pulmonary complication incidence in two treatment arms among primary lung~     cancer patients with COPD required single lobectomy from 3days before operation to 7 days~     after operation.~   "
42185|NCT02504788|"~     Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality~     for various settings of management in radiation oncology. For example, the indications for~     WBRT should include brain metastasis or metastases, the setting of prophylactic cranial~     irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and~     even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are~     essentially based on that it can target both microscopic and gross intracranial disease.~      In addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial~     disease control, WBRT might also prolong the time to develop neurocognitive function (NCF)~     decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms~     of the time course of WBRT-induced NCF decline, it might vary considerably according to the~     specific domains which are selected to be measured. Early neurocognitive decline occurs~     within the first 1 - 4 months after WBRT for brain metastases. The domains of early~     neurocognitive decline principally involve verbal and short-term memory recall.~      Since several decades ago, it has been understood that hippocampus plays an essential role~     in memory function. Not little evidence supports that radiation-induced damage to~     hippocampus should be strongly associated with NCF impairment. Furthermore, several studies~     have shown that isodose distribution in hippocampus is closely related to neurocognitive~     function in patients with benign or low-grade brain tumors. As a consequence, it is~     hypothesized that conformal hippocampal sparing during the course of WBRT (HS-WBRT) might~     provide significant preservation in terms of cognitive function.~      This prospective cohort study aims to explore and evaluate the impact of the delivery of~     HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving~     prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it~     will also be investigated whether neurocognitive functional preservation can be achieved via~     the integration of hippocampal sparing with the course of WBRT.~   "
42186|NCT02504775|"~     This will be a monocentric, single blinded, randomized, single-dose, two-periods,~     two-sequence, crossover bioequivalence study of two oral formulations in healthy~     participants under fasting conditions.~   "
42187|NCT02504762|"~     To evaluate whether an HCR strategy is more or less effective than conventional coronary~     artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left~     anterior descending artery (LAD), who do not present in the context of acute ST-elevation~     myocardial infarction (STEMI).~   "
42188|NCT02504749|"~     This study aims to compare the time to regain intestinal motility after general anesthesia~     versus spinal anesthesia for cesarean section.~      A double blinded randomized controlled trial was conducted at the Department of Obstetrics~     and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University,~     Cairo, Egypt, between July 20 and November 20, 2015. In the study hospital, the total number~     of deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total~     number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.~   "
42189|NCT02504736|"~     To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South~     Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains~     above target despite optimal statin use.~   "
42193|NCT02504684|"~     Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus~     1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients~     with varicose veins associated with great saphenous reflux were included. Procedures were~     performed between February and April of 2013. The 1470-nm laser ablation was performed in~     continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set~     between 5 and 6 W. Checking for vein closure was performed during the thermal ablation~     procedure, LEED (linear endovenous energy density) being calculated after the procedure.~     Follow-up data were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and~     involved clinical and ultrasound evaluation, measurement of occlusion extent.~   "
42194|NCT02504671|"~     This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group,~     placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in~     combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid~     arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised~     into the study, following a screening period of up to four weeks. The total treatment period~     is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects~     will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165~     doses, in combination with MTX (at a weekly dose between 15-25 milligram [mg]), previously~     received for at least 12 weeks, with a stable and tolerated dose and route of administration~     for >=4 weeks. Escape therapy is provided at specified timepoints in the protocol for~     subjects that do not achieve adequate disease improvement.~   "
42195|NCT02504658|"~     This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of~     a cell phone text message program for lifestyle goal setting among adolescents with type 1~     or type 2 diabetes. The study entails a small-scale randomized controlled trial with~     pre-post test of a mobile text message program.~   "
42196|NCT02504645|"~     This current Phase 3 study will evaluate the efficacy and safety of administration of~     subcutaneous (sc) IPP-201101 in patients with active SLE.~   "
42197|NCT02504632|"~     Study of platelet activation by severe aortic stenosis and its correction by Transcatheter~     Aortic Valve Implantation (TAVI)~   "
42198|NCT02504619|"~     CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells~     composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to~     evaluate the safety and efficacy of CordIn™.~   "
42199|NCT02504606|"~     This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan~     with Amosartan, which was available commercially after single oral dose in healthy male~     subjects.~   "
42200|NCT02504593|"~     The investigators propose to implement a new mobile interface that automatically reads and~     troubleshoots malaria rapid diagnostic test (RDT) cassettes. This device, called a Deki~     reader (DR), will allow the investigators to establish an extensive quality assurance~     program of malaria diagnosis performed by trained community health volunteers (CHVs). The~     study will lease 10 DRs and rotate them amongst 200 CHVs performing community-based malaria~     diagnosis through rapid diagnostic testing. The study setting is Bungoma East subcounty and~     Kiminini subcounty in Kenya. The overall goal is to measure and improve the quality of~     malaria diagnosis by CHVs using malaria RDTs. The investigators aim for every CHW to exceed~     90% sensitivity and specificity and zero operator errors within six months. There are no~     appreciable risks to the CHV associated with evaluation by the DR device. The investigators'~     analysis will focus on descriptive statistics of RDT use and accuracy amongst all~     participating CHVs.~   "
42201|NCT02504580|"~     A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and~     Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical~     Application Following Unilateral Open Inguinal Herniorrhaphy~   "
42202|NCT02504567|"~     This protocol aims at assessing the efficacy of performing catheter ablation for atrial~     fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF)~     catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3~     months after the procedure will be performed in both groups. MRI analysis will detect~     ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare~     the number of gaps in the laser catheter and the RF group. The secondary endpoint of the~     study is recurrence of AF after 12 months. The target population of the study is patients~     with paroxysmal or persistent AF undergoing AF ablation.~   "
42203|NCT02504554|"~     This is an open-label clinical trial to investigate a combination therapy for treating~     gastrointestinal problems in children with autism spectrum disorders.~      The combination therapy includes beneficial bacteria.~   "
42204|NCT02504541|"~     Evaluation of safety of a concentration controlled testosterone enanthate QuickShot~     Testosterone regimen administered subcutaneously once each week to adult males with~     hypogonadism.~   "
42205|NCT02504528|"~     The purpose of this study is to establish the methodology of bronchial provocation tests~     with house dust mites in China, and to evaluate its safety and effects on upper and lower~     airways inflammation.~   "
42206|NCT02504515|"~     Patients will be randomly assigned to two separate groups. Both patient groups will be~     evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before~     the study begins and at intervals of six months during a period of one year for a total of~     three evaluations. Group one will be made up of patients who will begin homeopathy or~     acupuncture or anthroposophic medicine treatment and patients from group two will start~     homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the~     study. Each one of these three research branches will be done independently (Homeopathy~     versus control; Acupuncture versus control; Anthroposophic Medicine versus control).~     Conventional medical treatment will be available for all patients in both groups. A data~     sheet will be filled out on each patient with data as to age, education level, marital~     status and the patient's own perception of their health status. During the interviews the~     interviewer will have no influence whatsoever over the respondents' answers.~     Integrative/complementary or traditional medicine doctors do not participate in the research~     and will not be informed about which patients are participating in this project, and as such~     the research will be blinded for these doctors. Minitab software, version 16, was used for~     sample calculation through the module Power and Sample Size. Sample calculation option for~     paired t-tests before and after intervention demonstrated the need to randomize 906~     patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225~     patients in the control group), 228 patients for acupuncture branch (114 patients in the~     acupuncture group and 114 patients in the control group), and 228 patients for~     anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114~     patients in the control group).~   "
42286|NCT02503475|"~     The purpose of the Stanford Center for Back Pain is to investigate and characterize the~     mechanisms of four treatments for chronic low back pain. These interventions (research~     treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction,~     cognitive behavioral therapy, and acupuncture treatment. The investigators plan to~     characterize both mechanisms of treatment effects and efficacy.~   "
42207|NCT02504502|"~     Current lab reports are designed to communicate results from the laboratory to the provider;~     they are not designed to be accessible to patients. The investigators believe that a new~     type of genomic test report, tailored for patient- as well as provider-use, will enable~     patients to have access to information they can understand allowing them to be more involved~     in the management of their disorders, better navigate the health care system, and make more~     informed decisions about their health and health care in conjunction with their providers.~     This approach has the potential to improve outcomes from both the patient and provider~     perspectives.~      The investigators propose to study the research question, Can a genomic laboratory report~     tailored for both providers and families of patients improve interpretation of complex~     results and facilitate recommended care by enhancing communication and shared decision~     making?~   "
42208|NCT02504489|"~     The primary purpose of the study is to compare the overall survival of NSCLC patients~     receiving second- or third-line chemotherapy with docetaxel + plinabulin (DP Arm) to~     patients treated with docetaxel + placebo (D Arm) for advanced or metastatic disease.~      Secondary purposes of the study are:~        1. To compare the neutropenia (frequency, severity and clinical sequelae), duration of~          response, quality of life, response rate and progression free survival in patients with~          NSCLC treated with DP to patients treated with D as second- or third-line chemotherapy~          for advanced or metastatic disease; and~        2. To compare the safety and adverse event profiles of DP to D respectively, as well as~          dose delays, dose modifications, and/or dose discontinuation of docetaxel due to safety~          concerns in the two treatment arms.~        3. To evaluate population pharmacokinetics in patients enrolled in China and western~          countries (US and Australia).~   "
42209|NCT02504476|"~     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown~     and remove the drug from the body in healthy participants and subjects with schizophrenia~     and whether it causes any side effects.~   "
42210|NCT02504463|"~     This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male~     volunteers.~   "
42211|NCT02504450|"~     To review records of patients treated with antipsychotics (including Adasuve, Geodon,~     Haldol) in order to evaluate outcomes.~   "
42212|NCT02504437|"~     The purpose of the present study is to evaluate the efficacy of the preconditioned~     autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.~   "
42213|NCT02504424|"~     This study is designed to allow existing investigators continued access to the AeroForm~     Tissue Expander to treat patients while AirXpanders completes a marketing application and~     during the review process by FDA.~   "
42214|NCT02504411|"~     The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC)~     with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.~   "
42215|NCT02504398|"~     Vaccine injections are a significant source of pain for infants. Altering the injection~     speed when administering vaccines may be an effective intervention and is feasible (cost~     neutral). At present, there are no data regarding impact of injection speed on vaccine~     injection pain in infants. The aim of this study is to address this knowledge gap and to~     compare the impact of slow and fast vaccine injection speeds on pain during routine infant~     vaccinations.~   "
42216|NCT02504385|"~     The subjet of this study is to explore the effect of using virtual reality environment at~     the clinic and at home (using Timocco) on the motor and participation abilities of children~     with DCD (Developmental Coordination Disorder).~      The study will examine the efficacy of using virtual reality gaming environment (Timocco)~     for treating children with DCD and the use of remote therapy, by shifting the focus of~     therapy from the clinic to the home environment, using the remote control system of Timocco~     for home practice.~   "
42217|NCT02504372|"~     In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who~     have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant~     chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is~     that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.~   "
42218|NCT02504359|"~     This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell~     transplant followed by ixazomib citrate maintenance therapy in treating patients with~     multiple myeloma that has returned after a period of improvement and is likely to recur~     (come back), or spread. Giving chemotherapy before a donor peripheral blood stem cell~     transplant helps stop the growth of cells in the bone marrow, including normal blood-forming~     cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Giving ixazomib citrate after the transplant may improve~     the overall treatment outcome without causing additional toxicities.~   "
42219|NCT02504346|"~     Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once~     daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or~     metastatic NSCLC, who have progressed following treatment with an approved epidermal growth~     factor tyrosine kinase inhibitor agent.~   "
42220|NCT02504333|"~     The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane)~     and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously~     untreated, metastatic pancreatic adenocarcinoma~   "
42221|NCT02504320|"~     This study will assess the relative bioavailability, safety and tolerability following~     administration of 80 mg single oral doses of 4 febuxostat extended release (XR)~     formulations.~   "
42222|NCT02504307|"~     Prospective, single center, randomized and non-inferiority study, to include up to 60~     patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6~     and 12 months. At 3 months all patients will be submitted to angiographic and OCT~     evaluation.~   "
42223|NCT02504294|"~     A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira~     Epoetin and Standard of Care Epogen.~   "
42224|NCT02504281|"~     To determine whether there is higher incidence of skewed X chromosome inactivation(SXCI) in~     the recurrent miscarriage(RM) population compared with normal population, and screen the~     possible genetic sites that may lead to SXCI and RM by genome microarray analysis of the RM~     patients with SXCI and normal females with SXCI.~   "
42225|NCT02504268|"~     The purpose of this study is to determine if abatacept is effective in the treatment of~     early rheumatoid arthritis.~   "
42226|NCT02504255|"~     Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable~     remission. the probability of recurrence of CD in a patient in remission is even stronger if~     it pre-exists endoscopic lesions of the intestinal mucosa.~      The mucosal healing exploration needs the realization of an ileo-colonoscopy under general~     anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its~     too frequent repetition. we do not currently have noninvasive and reliable markers able to~     predict the occurrence of thrust of CD and allow the introduction of a more suitable~     treatment.~      Indeed, relapse prevention is the best way to avoid complications and formation of lesions~     that lead to the irreversible medical treatment failure and surgery.~      Since during the CD, it is the immunological changes that lead to inflammation and lesions,~     we make the assumption that the ability of certain markers immunological to predict a~     relapse of CD is higher than that of other in particular inflammatory markers.~      This work should help to identify the profile of patients with CD in remission but at high~     risk of recurrence. It will specify i) the potential new markers immunological, from the~     pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest~     of different inflammatory markers used in routine or during the CD evaluation ; iii)~     Finally, the stress and the management of stressful events in the occurrence of a relapse.~      This work also will specify the evolution of different markers at the moment of thrust~   "
42227|NCT02504242|"~     A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate~     the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody~     Fusion.~   "
42228|NCT02504229|"~     This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with~     cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil~     Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or~     metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and~     oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin~     adjuvant chemotherapy served as controls.~   "
42229|NCT02504216|"~     The purpose of study is to test whether rivaroxaban added to standard of care treatment,~     when compared to placebo, has the potential to reduce the incidence of the clinical events~     related to the clots and complications of the heart and brain (CV death, MI, or stroke) or~     the legs (acute limb ischemia or major amputation) in patients who had undergone recent~     procedure(s) to improve the blood flow of their legs.~   "
42230|NCT02504203|"~     The purpose of this study is to determine whether BCG vaccination shortly after birth can~     reduce early infant mortality in a rural setting.~   "
42231|NCT02504190|"~     Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after~     first-line treatment, high-dose chemotherapy conditioning followed by autologous~     hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces~     the risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive~     lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is~     the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no~     longer available in Europe.~      The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM~     regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for~     the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results~     of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However,~     no study have been performed prospectively. Only small series and case reports have been~     reported.~      If the study confirms the results of retrospective studies, conditioning by TEAM could~     become a new standard in auto-HSCT for the treatment of lymphoma.~      This study is non-interventional, prospective with 3 centers.~      All included patients will receive, according to standard practice and drug label in France,~     the following diagram:~        1. Conditioning:~             -  Thiotepa 8 mg / kg to J-6~             -  Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)~             -  Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)~             -  Melphalan 140 mg / m² on day-1~        2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant~        3. Care supports: Patients will be treated according to the usual procedures of centers~          participating in the study at the discretion of the investigator.~        4. Follow-up of patients will not be changed by the study.~      The main objective of the study is to evaluate the progression-free survival (PFS) of~     lymphoma patients treated with autologous stem cells after conditioning by TEAM~      Secondary objectives are:~        -  To evaluate overall survival;~        -  To assess the response to treatment;~        -  to evaluate the incidence of relapse;~        -  to assess the toxic transplant related mortality;~        -  to study transplant-related morbidity (infections, nutritional and gastrointestinal~          toxicity, immune reconstitution).~   "
42232|NCT02504177|"~     This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial~     fibrillation ablation. The investigators will compare the bleeding complications were~     classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission~     and increased in the length of hospital stay during the 30-day post-radiofrequency catheter~     ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients~     who stop NOAC in the morning of the procedure.~   "
42233|NCT02504164|"~     Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and~     minimizing patient movement is of key importance for successful outcome. Propofol has widely~     replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the~     quality of procedure in our past study. However, despite higher satisfaction scores of the~     endoscopists and faster post-procedural recovery, patient satisfaction scores were found to~     be higher in patients that received midazolam and meperidine instead of propofol and~     remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather~     than the quality of sedation itself. Investigator hypothesized that by premedicating the~     patient with low lose midazolam before receiving sedation for ESD with propofol and~     fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.~   "
42234|NCT02504151|"~     Cannabidiol (CBD) is a component of herbal cannabis that is present in varying~     concentrations in cannabis extracts. CBD has been shown to produce central effects including~     hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators~     hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction~     in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2)~     Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale~     (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the~     Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale~     (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to~     receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo~     (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods~     will be separated by a washout of at least 2 weeks. During each period subjects will receive~     study medications (CBD [total 800mg/day] or placebo) for a period of 4 weeks.~   "
42287|NCT02503462|"~     The purpose of this study is to assess whether a boosting by cobicistat results in similar~     concentrations of darunavir in the brain compared to a boosting by ritonavir.~   "
42239|NCT02504086|"~     The purpose of this study is to evaluate the effect of online support for diabetes~     self-management for patients with Type II diabetes in the Vancouver region. Patients will be~     invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare~     providers (video calls in a secure Website). Participants will also have access to the use~     of an online personal health record -- a place to store healthcare information for the~     patient and healthcare provider to view. Patients' ability to care for their diabetes will~     be measured at the beginning and the end of the study. Additional measures include glycaemic~     control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy,~     patient satisfaction with care and perceived ease of use and perceived usefulness of the~     technology.~   "
42240|NCT02504073|"~     The goal of this study is to find out what clinical reasoning process physiotherapists~     undergo when observing hemiplegic patients gait.~   "
42241|NCT02504060|"~     This study is a randomized double-blind placebo-controlled clinical trail to evaluate the~     clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D~     patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment~     group, 360 for placebo group) in this research are accord with the Rome III diagnostic~     criteria, screening/import period pain intensity scores of the NRS(numerical rating scale)~     week mean value are 3.0 plus and the days which at least more than one time a stool type are~     6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open~     treatment period (12 weeks), follow-up period (2 weeks). The main outcome measures are pain~     intensity (NRS score 11 point scale) and stool type ( Bristol type), and secondary endpoints~     included overall symptoms sensory scores, defecation frequency, abdominal distension,~     defecation urgency and quality of life parameters (IBS-QOL scale).~   "
42242|NCT02504047|"~     The administration of high-dose chemotherapy followed by the infusion of blood or bone~     marrow stem cells (stem cell transplantation) from a matched donor has become standard~     treatment for patients with high-risk or relapsed hematological cancers. Currently, donors~     are found for approximately 80% of people who require such treatment, although the chance of~     finding a donor is much lower in some ethnic communities. In the current study the~     investigators will offer patients requiring transplantation, but for whom well matched~     donors cannot be identified either from within the family or on the donor registry, a~     transplant from a half-matched (haploidentical) family member. A myeloablative conditioning~     regimen and un-manipulated peripheral blood stem cells will be used. Post-transplant~     cyclophosphamide, tacrolimus and mycophenolate mofetil will be used to prevent graft versus~     host disease (GVHD). The primary outcome measure will be 6 month survival free from graft~     failure, relapse and grade 3-4 acute GVHD. Other outcomes of interest will include the~     frequency of Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall~     survival and progression-free survival.~   "
42243|NCT02504034|"~     To evaluate the values of portosystemic shunt and other interventional radiology approaches~     for treatment of symptomatic portal hypertension in patients with cavernous transformation~     of portal vein.~   "
42244|NCT02504021|"~     A randomized clinical trial for patients with end stage renal disease in which a family~     consultation condition is compared against a treatment as usual control condition on the~     hospital readmissions after 1 month as the primary outcome variable.~   "
42245|NCT02504008|"~     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the~     efficacy and safety of AXS-02 in patients with CRPS-I.~   "
42246|NCT02503995|"~     This study aimed to investigate whether there are measurable differences in CHANS function~     in pregnant women who receive only standard antenatal care compared with those who~     additionally undertake a programme of regular physical exercise.~   "
42247|NCT02503982|"~     Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and~     prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children.~     valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC)~     (0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety.~     Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few~     published dosing algorithms result in AUC out of range.~      Objective: To prospectively validate a Valganciclovir administration dosing regimen and~     compare it to other dosing algorithms.~      Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary~     pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing~     regimen was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For~     impaired renal function, stratified dose reduction was used. Blood was withdrawn at steady~     state: 2, 5 and 10 hours post dosing. Drug level was analyzed by high pressure liquid~     chromatography (HPLC).~   "
42248|NCT02503969|"~     The primary aim of this project is to examine the association between having a long-term~     condition (morbidity) and screening uptake for colorectal cancer. Whilst this project will~     consider all morbidity and co-morbidities, there will be a particular focus on common mental~     health disorders, such as depression and anxiety.~      The secondary aim of this project is to examine other factors that may influence uptake~     rate. Information on a wide array of potential factors is available for this project. These~     include demographics (age, gender, ethnicity), socio-economic status (deprivation, education~     status) and lifestyle (smoking status, drinking patterns, degree of exercise). In addition,~     any potential moderating effect of these factors on the association between morbidity and~     screening uptake shall be explored.~      In summary, the following shall be explored:~        -  Uptake rates by type of mental health disorder.~        -  Uptake rates by chronic physical health problems.~        -  Associations between uptake, morbidity (both physical and mental) and broader health~          determinants such as demographics, socio-economic status and lifestyle.~   "
42249|NCT02503956|"~     Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the~     management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy~     patients.~   "
42288|NCT02503449|"~     The purpose of the study:1.Improve the understanding of the risk factors of pulmonary~     cryptococcosis;2.Improve the awareness of pulmonary cryptococcosis clinical and imaging~     manifestations;3.Grasp pulmonary cryptococcosis patients of clinical and imaging~     manifestations in different conditions;4.Learn about antibacterial activity of antifungal~     drugs for cryptococcosis in China.~   "
42250|NCT02503943|"~     Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese~     diabetes patients are combined with dyslipidemia or hypertension. The clustering of~     diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events~     for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent~     years. It was reported that beside its hypoglycemic and losing weight effects, activator of~     GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Therefore,~     activation of GLP-1 receptor may become a new comprehensive treatment strategies for~     improving glucose and lipid metabolism, blood pressure level and cardiovascular~     complication. But, it is lack of evidence-based medicine proof on the relationship between~     GLP-1 and blood pressure or serum lipid. So, investigators designed a prospective,~     randomized, open-label, active control study, and try to evaluate the effects of activator~     of GLP-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and~     lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.~   "
42251|NCT02503930|"~     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous~     every day phenomena. For example, people frequently walk while talking on a cellphone or~     drive while talking to a passenger. Often, the performance of one or more of these~     simultaneously performed tasks may deteriorate when another task is carried out at the same~     time, even in healthy young adults. This reduction in performance is referred to as the DT~     deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD)~     than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern,~     as manifested, for example, in increased gait variability, exacerbating instability and fall~     risk.~      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance~     following tDCS.~      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will~     increase DT performance and prefrontal activation.~   "
42252|NCT02503917|"~     This study will establish the feasibility and accuracy of localising and outlining the~     uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. This~     will enable us to determine whether or not ultrasound will be a good option to ensure the~     correct patient position prior to radiotherapy for cervical cancer patients.~   "
42253|NCT02503904|"~     The principal aim of the present research is to compare two methods of antibiotic delivery:~     concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD)~     versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site~     infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the~     incidence of SSI compared to IVAD.~      TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of~     tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L),~     epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.~      A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention~     of post-operative venous thromboembolism (VTE).~   "
42254|NCT02503891|"~     M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide -~     MP-1™.~      M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing~     process and supplies them to the customer.~      The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of~     using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical~     following up of patients for a period of 2 years .~   "
42255|NCT02503878|"~     Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to~     monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The~     purpose of this study is to observe the effectiveness of the Sedline monitor to detect the~     unilateral hemispheric EEG changes seen in Wada testing~   "
42256|NCT02503865|"~     Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis~   "
42257|NCT02503852|"~     The primary objective of this study is to evaluate the safety and feasibility of the~     Celution and Puregraft Systems in the processing and preparation of an autologous fat graft~     enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia~     androgenetica.~   "
42258|NCT02503839|"~     Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug~     resistant (MDR)-TB there is restricted treatment options. This calls for research of new~     immune-modulating treatment strategies that can strengthen the patients immune system to~     better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator~     prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue.~     Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve~     the immune system and strengthen vaccines responses.~      Hypothesis~        1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune~          responses that favour TB survival, but this can be abrogated by COX-2i.~        2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine~          and enhanced by COX-2i will improve immune-mediated host clearance of TB.~        3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB~          chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB.~      Approach to test the hypothesis~        1. Study design: 4-arm, open and randomized clinical intervention trial of patients~          starting treatment for active TB in specialized Norwegian TB centres and where two arms~          will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only~          and the last arm serve as control receiving only standard anti-TB therapy. For safety~          precautions, only patients bearing sensitive TB strains are included and study arms~          will be sequentially introduced.~        2. In a mouse model examine in more detail the effects of reversion of chronic~          inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses,~          immune regulation, correlates of protection and survival in a well-characterized model~          for TB-exposed mice.~   "
42259|NCT02503826|"~     Effective postoperative pain control is essential for patients and inadequate postoperative~     pain relief can cause mental and psychological sufferings. Despite the growing concern on~     postoperative pain management, acute postoperative pain is still poorly managed. Though~     numerous clinical practice guidelines for postoperative pain management have been published~     throughout the last decades, inadequate pain relief remain a big health care issue.~     Sufentanil has been used as satisfied pain control drug because of its strong potency of~     analgesia for a long while. But its use in patient controlled intravenous analgesia (PCIA)~     has not been clarified. And the dilemma of safety concern and insufficient dosage of~     analgesic is a common problem. Thus the investigators design this prospective randomized~     controlled double blinded trial to observe the efficacy and the optimal dose of sufentanil~     in PCIA in patients underwent moderate surgery for the purpose of providing reference in~     clinical practice.~   "
42339|NCT02503046|"~     Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common~     risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas~     Gingivalis levels play an important role in the progression of both the diseases.~   "
42260|NCT02503813|"~     One required examination for declaration of death by neurological criteria is the apnea~     challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center~     response to a rise in CO2. The current guideline requires arterial sampling of CO2 and~     therefore either arterial puncture or arterial catheter placement for the examination.~     Arterial catheter is an invasive monitoring device and is not without complications. Recent~     studies have demonstrated that there is a direct correlation between peripheral venous and~     arterial blood gas measures and that peripheral venous CO2 measures may be used as~     alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem~     response during the apnea challenge test to a rise in venous CO2 and correlate it with the~     rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise~     between the venous and arterial CO2 during the apnea challenge test and eliminate the~     necessity of arterial blood sampling for the sole purpose of apnea challenge test in the~     future.~   "
42261|NCT02503800|"~     The investigators wish to evaluate the association between tryptase values as well as c-Kit~     mutation and adverse effects in the course of immunotherapy. The investigators also intend~     to assess the effect of immunotherapy on tryptase levels.~   "
42262|NCT02503787|"~     The purpose of this study is to evaluate programming options in spinal cord stimulation for~     the management of chronic, intractable pain of the trunk and limbs.~   "
42263|NCT02503774|"~     The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,~     Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in~     Adult Subjects with Select Advanced Solid Tumors~   "
42264|NCT02503761|"~     Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature~     organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to~     narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new~     agents with a wider spectrum of activity.~      Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It~     is well tolerated by children and neonates, including preterm babies, and allowing~     monotherapy instead of combined therapy.~      Severe neonatal infections with increasing antibiotic resistance are major problems~     affecting morbidity and mortality in the NICU. Few number of new antibacterial agents~     entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will~     unlikely be available in the near future.~   "
42265|NCT02503748|"~     In a participatory process involving urologists and former patients, the project team has~     developed an online information system (tutorial) for patients with localized prostate~     cancer. In this field test, relevant outcomes are measured and the tutorial will be tested~     for its clinical applicability.~   "
42266|NCT02503735|"~     Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD)~     who are treated with Harvoni for 12 weeks have improvements in their kidney disease.~   "
42267|NCT02503722|"~     This phase I trial studies the side effects and best dose of transducer of regulated CREB~     activity 1/2 (TORC1/2) inhibitor INK128 when given together with epidermal growth factor~     receptor (EGFR) inhibitor AZD9291in treating patients with advanced EGFR mutation positive~     non-small cell lung cancer that has spread to other places in the body (advanced) and has~     progressed after treatment with an EGFR tyrosine kinase inhibitor. TORC1/2 inhibitor INK128~     and EGFR inhibitor AZD9291 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
42268|NCT02503709|"~     This phase I trial studies the side effects and best dose of heat shock protein (Hsp)90~     inhibitor AT13387 and CDKI AT7519 in treating patients with solid tumors that have spread~     from the primary site (place where they started) to other places in the body (metastatic) or~     cannot be removed by surgery. Hsp90 inhibitor AT13387 and CDKI AT7519 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
42269|NCT02503696|"~     The primary objective of this study is to gather stool samples from subjects with~     inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be~     utilized to help select molecular markers and determine the optimal sensitivity and~     specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).~   "
42270|NCT02503683|"~     The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and~     Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and~     Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.~   "
42271|NCT02503670|"~     The purpose of this study is to develop and pilot test HealthyDads.ca, a website for~     expectant first-time fathers who have known risk factors for depression.~   "
42272|NCT02503657|"~     This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month~     open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in~     moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally~     administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF~     per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are~     planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching~     placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will~     consist of males and females ranging in age from 21 to 80 years old, inclusive.~      The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26~     week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a~     Follow-up Visit (within 4 weeks after the last dose).~   "
42273|NCT02503644|"~     Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune~     origin. It is a life-threatening orphan disease with severe physical and psychosocial~     consequences. IVA337 has a novel mechanism of action and this study is designed to compare~     IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the~     treatment they are receiving and will be randomized to one of three treatment arms , either~     IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and~     during that time assessments will be made to monitor both the efficacy and safety of the~     treatment.~   "
42274|NCT02503631|"~     The primary objective of this study is to obtain de-identified, clinically characterized,~     stool and plasma specimens for use in assessing new markers for the detection of neoplasms~     of the digestive tract.~   "
42275|NCT02503618|"~     The scientific purpose of this study is to look at how substance use may relate to human~     immunodeficiency virus (HIV) infection among young black men who have sex with men in~     Atlanta.~   "
42277|NCT02503592|"~     This study will measure the effects of soft surgical techniques on vestibular function and~     quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the~     investigators will attempt to systematically evaluate the utility of different~     electrophysiological measures of vestibular system function in surgical ears.~      Vestibular system function in CI patients will be evaluated pre-surgically and twice~     post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques -~     such as VNG, rotational testing, and air conduction VEMPs - will be compared to and~     cross-checked with newer techniques including video head impulse testing (vHIT) and bone~     conduction VEMPs.~   "
42278|NCT02503579|"~     This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in~     the relationship between physical fitness/activity and executive functions in typically~     developing children and children with Autism Spectrum Disorder, Development Coordination~     Disorder , Attention Hyperactive Disorder.~   "
42279|NCT02503566|"~     Cardiac allograft vasculopathy (CAV) is characterized by marked intimal proliferation and~     concentric vascular thickening and fibrosis. CAV remains the leading cause of late morbidity~     and mortality in heart transplant recipients. Optical coherence tomography (OCT) is a new~     generation catheter-based modality that acquires images at a spatial resolution of 10-20 μm~     which is 10-fold greater than that of intravascular ultrasound (IVUS). OCT is currently the~     most sensitive imaging technique for early CAV detection. Recent studies proved that~     circulating human leukocyte antigen (HLA) directed donor-specific antibodies correlate with~     increased mortality and CAV. Contradiction of scientific results has been reported regarding~     increased resting heart rate and development of CAV. Larger prospective studies using more~     sensitive CAV detecting methods are required to enhance our understanding. Novel~     immunosuppressants, mechanistic target of rapamycin (mTOR) inhibitors, may attenuate CAV~     progression and may improve long-term allograft survival owing to favorable coronary~     remodeling.~      Aim of the study: Use OCT imaging for identification of patients with early rapid~     progression of CAV (rapid progressors) and to identify the critical risk factors responsible~     for CAV progression. The impact of conventional and heart transplant (HTx) specific risk~     factors, such as donor-specific antibodies or rapid heart rate will be studied in a~     prospective, national-level cohort study. The implication of OCT results will lead to~     adjustment of immunosuppressive therapy in one year after heart transplant to prevent~     further progression of the disease in CAV rapid progressors.~      Working hypotheses:~        1. Patients with rapid progression of cardiac allograft vasculopathy can be identified by~          increased titers of donor specific anti-human leukocyte antigen (anti-HLA) and/or~          antibodies against major histocompatibility complex (MHC) class I-related chain A~          (MICA) antibodies.~        2. Specific high-risk characteristics of anti-HLA antibodies can be identified that are~          associated with particularly high rate of CAV progression (vascular complement~          activation in biopsies, certain HLA haplotypes).~        3. Tachycardia in heart transplant recipients represents a risk factor for development of~          cardiac allograft vasculopathy.~        4. Influence of anti-HLA antibodies and increased heart rate is independent of already~          established risk factors of CAV.~   "
42280|NCT02503553|"~     Identifying and making a decision about the best health treatment or screening option can be~     difficult for patients. Decision aids can be used when there is more than one reasonable~     option, when no option has a clear advantage in terms of health outcomes, and when each~     option has benefits and harms that patients may value differently.~      Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit,~     describe the options available, and help people to understand these options as well as their~     possible benefits and harms. This helps patients to consider the options from a personal~     view (e.g., how important the possible benefits and harms are to them) and helps them to~     participate with their health practitioner in making a decision.~      Cerebral aneurysms are common and potentially very dangerous. However, there are important~     treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current~     procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is~     amenable to either treatment.~      The treatment decisions are not simple, since each choice has its own trade-offs. How the~     benefits and trade-offs are valued varies across different patients, and, therefore, the~     right treatment decision needs to include greater patient participation. This starts with~     better communication of the probabilities associated with the outcomes of each option in~     terms that can be understood by patients. Equally important is helping the patients clarify~     their own treatment goals, as well as legitimizing patients' partnership in the~     decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are~     lacking in this area of medicine. We propose to investigate the impact of such decision aids~     on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping.~      Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients~     are associated with increased patient participation in the decision making process as~     indicated by the OPTION score~      Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients~     are associated with improved quality of life and patient satisfaction outcomes immediately~     preoperatively, and 30 days postoperatively.~   "
42281|NCT02503540|"~     This interventional study will evaluate the retinal vascular dynamics associated with~     Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME)~     or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein~     angiography and OCT angiography will be performed at multiple timepoints to assess the~     changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the~     study duration and compare these alterations to baseline.~   "
42282|NCT02503527|"~     The purpose of this study is to determine the efficacy and safety of a diabetes-specific~     tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in~     critically ill patients receiving insulin treatment for blood glucose management.~   "
42283|NCT02503514|"~     Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic~     agents will be evaluated for incidences of paradoxical immune reactions, the risk factors~     associated with those paradoxical immune reactions, and whether the paradoxical immune~     reactions and their associated risk factors differ based on formulation of biologic agent.~      Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to~     initiate treatment in 1 month~      Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed~     indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as~     serum and plasma for banking. Subjects will be followed at 6 month intervals either via~     email, telephone interviews or at the time of clinic follow-up visits. In the event of a~     de-novo paradoxical reaction, specific information will be collected from sites in an event~     capture form, with data abstracted from routine clinical care for the paradoxical reaction.~     Subjects will continue to be followed every 3 months after the event via email, telephone~     contact to determine whether resolution and/or recurrence occurred, and to determine any~     changes in medical therapy. Serum and plasma will be re-collected at the time of first event~     for comparison to baseline samples and to samples from controls (those on biologics without~     study documented paradoxical immune reactions). At resolution of the event, patient will~     return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular~     biologic treatment; therefore they will also be followed for paradoxical immune reactions,~     on any new biologic treatment they undergo while in the study.~   "
42284|NCT02503501|"~     This study evaluates the safety and effectiveness of intranasal (IN) glulisine in patients~     with amnestic mild cognitive impairment (aMCI) and probable Alzheimer's disease. Half of~     participants will receive IN glulisine, while the other half will receive IN placebo.~   "
42289|NCT02503436|"~     The main objective of the proposed non-interventional study is to obtain real-world~     effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer~     Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German~     hospitals and outpatient practices treated with olaparib.~   "
42290|NCT02503423|"~     This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660,~     determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended~     dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target~     engagement data, in subjects with advanced solid tumors or lymphoma for which standard~     curative measures do not exist or are no longer effective.~   "
42291|NCT02503410|"~     This study aims to compare the outcomes of a traditional, exercise-based rehabilitation~     intervention for chronic low back pain with the outcomes achieved by combining a traditional~     intervention with adjunct therapy delivered using an interactive gaming-based system for~     home-based therapy. 50 subjects with non-specific cLBP will be recruited in the study.~     Following baseline measures, study volunteers will be randomized to either the Usual Care~     alone group or to the Interactive Home-Based System group. In each group, an endpoint~     assessment session will be conducted at approximately 4 and 8 weeks post baseline measures.~   "
42292|NCT02503397|"~     This study evaluates auditory neural maturation by auditory brainstem evoked response in~     late preterm and term infants with in utero iron deficiency compared with neonates with~     normal in utero iron status.~   "
42293|NCT02503384|"~     Background: In mainland China, the development of pediatric liver transplantation (LT) has~     lagged behind that of adult LT during the past two decades, but it has been progressing~     immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric~     transplant center in mainland China.~      Aim and method: This study is performed for establishment of key techniques for pediatric LT~     in mainland China, including the indications and timing for pediatric LT, the criteria for~     donor selections, living donor LT planning, prevention and treatment for posttransplant~     complications, long-term follow-up management et al.~   "
42294|NCT02503371|"~     Since its introduction in 1978, over 3.75 million babies have been born using in vitro~     fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to~     supra-physiological levels . This increase in estrogen has been shown to cause a~     hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram~     (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and~     measuring visco elastic properties of the clot. The TEG shows effect of most of the~     components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis.~     Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K~     measurements reflecting fibrin function, MA reflecting mostly thrombocyte function,~     coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.~      In this study the investigators would like to measure serum estrogen levels and (TEG) in~     parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's~     influnence on coagulation parameters, and wheather or not a large sample size will effect~     primary outcomes.~      Secondarily the investigators would like to see if estrogen levels are predictors of~     coagulation parameters and see if age influences TEG parameters~   "
42295|NCT02503358|"~     This randomized phase I trial is studying the side effects and the best dose of selumetinib~     when given together with paclitaxel as a second line therapy in treating patients with stage~     IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor~     cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for~     cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving selumetinib together with paclitaxel may kill more~     tumor cells.~   "
42296|NCT02503345|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of different~     doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary~     hyperoxaluria and recurrent kidney stones.~   "
42297|NCT02503332|"~     The primary objectives of the study are to assess the safety, tolerability and evidence of~     activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic~     Atrophy associated with Age-Related Macular Degeneration (AMD).~   "
42298|NCT02503319|"~     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and~     oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post~     partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post~     partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a~     vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called~     primary when blood loss arose within 24 hours after birth.~      This is a open-trial randomized, longitudinal, controlled that including 486 subjects .~   "
42299|NCT02503306|"~     Primary Objective:~      o To assess the change in percent of sexual attempts in which subjects are able to maintain~     an erection of sufficient duration to have successful intercourse between the run-in period~     and treatment period:~        -  The change in percent of sexual attempts in which subjects are able to insert the penis~          into the partner's vagina.~        -  The change in score on the erectile function (EF) domain of the International Index of~          Erectile Function (IIEF) questionnaire.~      Secondary Objective:~      o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction~     (ED).~   "
42300|NCT02503293|"~     A randomised, cross-over study to compare quality of life and satisfaction in primary~     immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL~     administered with two different delivery devices: injections using pump or rapid push.~   "
42301|NCT02503280|"~     Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this~     phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection~     Catheter System will be tested. The randomized portion of the study will be conducted after~     a full review of the safety data from the pilot Phase by the Data safety monitoring board.~      Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac~     catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.~      Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.~   "
42302|NCT02503267|"~     The objective of the study is to investigate congenital disorders of glycosylation in~     congenital heart diseases without a clear molecular or genetic basis.~   "
42392|NCT02502097|"~     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of AF-219~     in subjects with Idiopathic Pulmonary Fibrosis (IPF) with persistent cough.~   "
42303|NCT02503254|"~     The overall goal of the study is to demonstrate the reduction of biomarkers of exposure~     (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in smokers~     switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0~     (CHTP 1.0) as compared to smokers continuing to use CC.~   "
42304|NCT02503241|"~     The goal of this interventional crossover study in morbidly obese intubated and mechanically~     ventilated patients is to describe the respiratory mechanics and the heart-lung interaction~     at titrated positive end-expiratory pressure levels following a recruitment maneuver with~     transthoracic echocardiography and electric impedance tomography imaging.~   "
42305|NCT02503228|"~     Patients who have a large enough defect in their knee cartilage will sometimes undergo~     surgery to transplant donor cartilage tissue into their defect in an attempt to repair the~     knee. The donor cartilage tissue must be fully tested for disease and contamination before~     it can be placed into a patient. This time, along with the time needed to coordinate the~     surgery and transport the tissue to the hospital, can be substantial. Cartilage tissue does~     not last for long outside a body and the fresher the tissue is, the more likely it is that~     the patient receiving the transplant will heal better.~      The MOPS was developed to preserve the cartilage tissue better than the currently standard~     preservation system is able to. Patients that are enrolled into this study will receive~     cartilage tissue that has been stored in the MOPS instead of the currently standard~     preservation system. Their surgical procedure will not change and be performed as per usual.~     The patient will then be followed for a period of two years in which their progress will be~     assessed using surveys and the healing and integration of the transplanted tissue will be~     assessed using diagnostic imaging and blood and urine samples.~   "
42306|NCT02503215|"~     To study the effects of compression stockings on sleep apnea in hemodialysis patients with~     diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift~     theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper~     airways edema.~      The aim of this study is to evaluate if compression stockings could improve such nocturnal~     volume redistribution and, therefore, improve obstructive sleep apnea.~   "
42307|NCT02503202|"~     The study will evaluate the safety and immunogenicity of 3 consistency lots and a high-dose~     lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this~     study is to demonstrate consistency in the immune responses of participants receiving 3~     separate lots of V920 (at release dose) through 28 days postvaccination. A subset of~     participants representative of all treatment groups will continue through 24 months~     postvaccination in the extension study for the evaluation of safety, and durability of~     immune response. Safety of the vaccines and matching placebo will be evaluated through 6~     months postvaccination for all participants and through 24 months postvaccination for~     participants continuing in the study extension.~   "
42308|NCT02503189|"~     The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to~     evaluate safety in dry eye patients with Sjögren's syndrome~   "
42309|NCT02502526|"~     The purpose of this study is to demonstrate that the Centurion® Vision System used with the~     45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti®~     Vision System used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction~     surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities classification~     system II (LOCSII)].~   "
42310|NCT02502513|"~     This pilot study aims to investigate the effects of a brief computerized intervention (the~     computer game Tetris) on intrusive memories and other posttraumatic stress symptoms~     following an emergency cesarean section. Patients who have undergone an emergency cesarian~     section will be randomly allocated to either the brief computerized intervention or usual~     care within the first 6 hours following the operation. Participants will be followed up at~     one week and one month. It is predicted that participants given the brief computerized~     intervention will develop fewer intrusive memories and less severe clinical symptoms than~     those who are not. This will inform the potential future development of a simple~     computerized intervention to prevent distressing psychological symptoms after a traumatic~     event such as an emergency cesarean section.~   "
42311|NCT02502500|"~     To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when~     administered alone and following multiple daily doses of AKB-6548.~   "
42312|NCT02502487|"~     This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB)~     in men undergoing rigid cystoscopy.~   "
42313|NCT02502474|"~     Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and~     colonic) of S. aureus in patients without chronic digestive disease who are going to have a~     colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity~     of strains isolated from each site will be analyzed using molecular tools. The aim of this~     study is to better estimate the digestive reservoir of S. aureus to better prevent~     endogenous infections due to this bacterium.~   "
42314|NCT02502461|"~     Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when~     the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube~     misplacement is an uncommon but significant cause of hypoxemia and death during general~     anesthesia as well as in the care of critically ill patients.~      Hypotheses: A specific manoeuvre to palpate the inflated ETT cuff, with fingers anterior to~     the trachea, moving the ETT caudally then rostrally following intubation, will enable~     correct depth placement of the tip of the ETT within the trachea (more than 2.5cm above the~     carina with cuff below the vocal cords) more frequently than routine care. This will not~     cause tissue damage as measured by sore throat.~   "
42315|NCT02502448|"~     Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating~     cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well~     established.~      Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly~     allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced~     hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.~      After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles~     are analyzed.~      As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be~     determined at 10 min after ANH in Group-ANH and that at control.~   "
42316|NCT02502435|"~     This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent~     studies in animals and healthy participants suggest that unusual eating habits may be~     connected to a change in the 24-hour rhythm of the blood fats the investigators wish to~     measure. The investigators will ask persons suffering from night eating syndrome, a~     condition where people eat additional meals throughout the night, to participate in this~     study. Healthy volunteers who are of the same age and gender, and have a comparable~     body-mass-index, a number calculated from a person's weight and height, will also be asked~     to participate.~      The aim is to learn how the 24-hour rhythm of the blood fats the investigators measure~     differs between the persons experiencing the night eating episodes and persons who do not.~   "
42317|NCT02502422|"~     Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord~     paralysis, sorethroat. The investigators will study correlation between laryngeal mask~     airway cuff volume and pressure and physical examination of head and neck.~   "
42318|NCT02502409|"~     This study will examine two groups of subjects with factor IX (FIX) deficiency: 1) those~     with a current or history of inhibitors to FIX, and; 2) groups of two or more affected~     brothers, with or without inhibitors. The overall goal is to characterize the study groups~     in terms of their medical history, their patterns of bleeding, their care, quality of life,~     and complications including the development of joint disease, inhibitory antibodies to FIX,~     use of immune tolerance induction (ITI) and outcome.~   "
42319|NCT02502396|"~     The primary objective of this study is to evaluate the practice patterns of rivaroxaban~     usage invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer~     patients.~      The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding~     for cancer patients on rivaroxaban.~   "
42320|NCT02502383|"~     Using a previously created weight management program for adolescents, the intervention will~     be implemented through school-based health centers (SBHC) and will be delivered by SBHC~     providers trained in Motivational Interviewing. Students at intervention school sites will~     be compared to students at control school sites. All students will have baseline, 1 year,~     and 2 year follow-up to assess if students in the intervention school sites will have~     improved risk factor profile for metabolic syndrome, improved nutrition and increased~     physical activity when compared with students at control school sites.~   "
42321|NCT02502370|"~     The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA)~     remains unproven and awaits the results of a large, global, prospective, phase III,~     randomised, controlled trial. Across the 830 million population of North America and Europe,~     there are approximately 3,000 patients with stage I-III SBA every year who would be~     potentially eligible for such an adjuvant chemotherapy trial.~      Given the absence of good-quality and evidence-based data, it has been agreed that a trial~     considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with~     stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant~     chemotherapy is uncertain. For those patients with stage I-III SBA who, with their~     oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence~     are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation~     between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin~     chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those~     patients who do not consent to be randomised will be offered registration to allow~     collection of demographic, clinicopathological and survival data, thereby making optimal use~     of the rare patient population available. In addition, archival Formalin Fixed Paraffin~     Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every~     registered patient to allow molecular profiling and future translational research. A~     questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch~     syndrome etc) will be completed along with the other collected data on all registered~     patients.~   "
42322|NCT02502357|"~     This is a randomized clinical trial comparing the severity of post-operative pain and use of~     pain medication in women who are and are not exposed to healing statements before undergoing~     vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis~     is that those who are read healing statements before surgery will require less~     post-operative pain medications and experience less severe pain than those who do not hear~     the statements.~   "
42323|NCT02502344|"~     This research would take medical interventions in subjects of insulin resistance without~     abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose~     tolerance in different groups.~   "
42324|NCT02502331|"~     -  Number of doses and intervals: Two doses, 2 weeks apart~        -  Method of administration: Oral administration~        -  Volume of vaccine to be administered: 1.5 mL/dose~        -  Observational period: 4 weeks (2 weeks after each dose)~        -  Number of visits: 3 visits~             1. Visit 1: Screening and enrollment (1st dosing)~             2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)~             3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation.~               This study will be carried out in healthy adults and children, at two sites,~               enrollment will be competitive between the sites. Subjects will be stratified~               according to age into adults (18~40 years of age) and children (1~17 years of~               age). According to the pre-generated randomization list, the participants will be~               randomized to the test or comparator groups (Visit 1) and will be given either the~               test vaccine or the comparator vaccine. For immunogenicity assessment, blood~               sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to~               vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the~               participants will be observed for 30 minutes post vaccination and instructed to~               record solicited adverse events that occur up to 6 days after vaccination on the~               participant diary card.~      This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two~     distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine~     administrator will remain blinded and will not handle the investigational product.~   "
42338|NCT02503059|"~     Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in~     moderate / severe plaque and the reasons that led to the abandonment. Besides factors that~     might have had a positive or negative influence on adherence to treatment and analysis of~     efficacy (PASI 75) and safety will be identified.~      All variables were collected through retrospective review of medical records of patients~     dermatology unit are made.~   "
42325|NCT02502318|"~     This is a national study that involves the participation of 600 lung cancer patients~     indicated that treatment is ablation of the pulmonary lobe. This technique is called~     lobectomy.~      Lobectomy may be performed in two different ways:~        -  Thoracotomy, which is the first reference approach and that is to make a large incision~          in the chest to pass between the ribs and spread the order to ablate the lobe.~        -  By video-thoracoscopy, which is a new surgical approach consisting in practice several~          small incisions in the chest wall to allow the introduction of a camera and special~          instruments to ablate the lobe.~      The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative~     expectoration and ventilation. As a result, the incidence of postoperative respiratory~     complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome~     (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in~     Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and~     quality of life when patients return home. The reduction in the incidence of complications~     should counterbalance the additional cost of video-thoracoscopy.~      This study aims to evaluate the effectiveness of these two techniques in relation to the~     quality of life and the costs they generate.~      Patients who agree to participate in the study were assigned to one or other of these groups~     (technical thoracotomy or video-thoracoscopy technique) by lot.~   "
42326|NCT02502305|"~     Aim of the study is to find out if the live online course is effective with regard to health~     promotion. Older adults receive support to initiate a health behavior (i.e., to enhance~     physical activity or to improve food habits).~      Motivation, confidence and self-management strategies are optimized to make sure~     participants are able to integrate the physical activity or healthy diet into their daily~     life.~   "
42327|NCT02502292|"~     In this study, the investigators evaluate an intervention aiming to increase participation~     and communication of older adults during primary care consultations with their General~     Practitioner(GP). The investigators are particularly interested in a Photo novel tool with~     this aim. Photo novels are picture stories, which have the advantage of using a familiar~     narrative format, thereby possibly increasing comprehension, personal involvement and~     motivation and self-efficacy to perform the relevant behaviors by offering role models~     (story characters that are similar to older adults themselves). The patient perspective on~     doctor-patient communication is underrepresented in most research. This study aims to~     incorporate the patient perspective in different ways: in addressing their needs and~     barriers during focus group discussions, in collecting their communication strategies and~     solutions to these barriers in the role play exercise, in involving them in developing the~     photo novel, and in studying their responses to the photo novel in the evaluation study the~     investigators describe in this research proposal.~   "
42328|NCT02502279|"~     General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis.~     Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and~     improve arterial oxygenation.~   "
42329|NCT02503176|"~     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in~     dry eye patients with Sjögren's syndrome.~   "
42330|NCT02503163|"~     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in~     dry eye patients with Sjögren's syndrome.~   "
42331|NCT02503150|"~     This trial is to compare the efficacy and safety of modified FOLFOX6 [mFOLFOX6, a specific~     chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin] chemotherapy plus~     Antigen Pulsed Dendritic Cells (APDC，a kind of autologous tumor lysates pulsed human~     dendritic cells vaccine) with modified chemotherapy alone in patients with metastatic~     colorectal cancer.~   "
42332|NCT02503137|"~     This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations~     of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical~     analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554~     and compared to placebo may lead to a greater understanding of the underlying mechanisms of~     action of SM04554.~   "
42333|NCT02503124|"~     A randomized controlled trial comparing wake therapy (single night) followed by bright light~     therapy to treatment as usual.~   "
42334|NCT02503111|"~     Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide.~     Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several~     cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal~     infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal~     cancer are much higher in men who have sex with men (MSM) than in the general population.~     Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making~     the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer~     prior to the adoption of routine cervical cytology screening. Despite these alarming~     statistics, there are no established protocols for optimal screening and treatment of anal~     HPV and cancer precursors, nor has there been any widespread rollout of organized screening~     programs anywhere in Canada. Further, not only does HPV directly cause significant disease~     in these men, but there is growing epidemiologic evidence that HPV infection may enhance~     sexual transmission of HIV. These significant knowledge gaps translate into fundamental~     deficiencies in care for HIV-positive MSM.~      The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large~     group of MSM to carry out a number of different studies. One key component of recruitment~     entails the mailing of invitations with educational materials in an invitational package to~     subjects in order to determine who would be interested in having anal cancer screening. In~     this way, the investigators will reveal factors that are important in acceptance of~     screening.~      The HPV-SAVE team brings together community and internationally-recognized experts in HPV~     and HIV disease and mucosal immunology, to better define the optimal approaches for primary~     and secondary prevention and treatment of HPV-associated anal disease among HIV-positive~     MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a~     co-factor for HIV transmission. This will yield critical information which can lead to~     improvement in the health of MSM, and will provide a foundation on which to build further,~     large-scale screening and treatment trials on a national level.~   "
42335|NCT02503098|"~     This study will augment an existing mobile application for individuals with eating disorders~     by developing adaptive, tailored content targeting remediation of cognitive distortions. The~     adaptive application will be deployed and assessed for efficacy relative to the standard~     product in a randomized controlled trial.~   "
42336|NCT02503085|"~     The purpose of this study was to determine the rate and extent of absorption of Ibuprofen~     suspension formulations.~   "
42337|NCT02503072|"~     The goal of this study is to identify ways for implementing small prizes allocated by a~     drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala,~     Uganda. The study is called Rewarding Adherence Program (RAP).~   "
42340|NCT02503033|"~     The purpose of this study is to evaluate the safety and tolerability of HMPL-523~     administered to patients with relapsed or refractory Hematologic Malignancies~      To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the~     dose limited toxicities associated with HMPL-523 when administered to patients with relapsed~     or refractory Hematologic Malignancies~   "
42341|NCT02503020|"~     Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6),~     and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of~     non-myelinated cell membranes in the central nervous system, including in the retina, hence~     the great importance of them for appropriate visual and cognitive development.~      In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor~     development in very preterm infants who had diets supplemented with different LCPUFA amount~     of AA to support the importance of sufficient AA values in formula.~   "
42342|NCT02503007|"~     Sustained high-intensity activity, such as survival training with little nourishment~     available, can result in a loss of muscle performance. This study will examine the effects~     of a nutritional supplement to maintain muscle and muscle performance during this period.~   "
42343|NCT02502994|"~     This study is designed to evaluate the safety and efficacy of a single injection of GEN0101~     in patients with recurrence of castration resistant prostate cancer.~      The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and~     followed subcutaneous injection) and two weeks of observation as one cycle treatment period.~     Each subject receive two cycle treatment period.~      Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per~     injection of GEN0101 Each group included minimal 3 subjects.~   "
42344|NCT02502981|"~     In stage 3 chronic kidney disease (CKD) the risk of death due to cardiovascular causes is~     high and greatly exceeds the risk of progression to end stage renal failure. This high~     cardiovascular risk is predominantly due to sudden cardiac death and heart failure,~     manifestations of left ventricular hypertrophy and fibrosis. Aldosterone appears to play an~     important role in the causation of this myocardial disease both by direct inflammatory and~     fibrotic myocardial effects and via increased arterial stiffness due to hypertrophy,~     inflammation, and fibrosis within the media of large arteries. Levels of aldosterone are~     high in CKD despite sodium overload and treatment with angiotensin-converting enzyme (ACE)~     inhibitor or angiotensin receptor blocker (ARB) drugs due to the twin phenomena of~     aldosterone escape and breakthrough. In a previous British Heart Foundation funded study,~     Birmingham investigators showed that the addition of the mineralocorticoid receptor blocker~     (MRB) spironolactone to background therapy with ACE inhibitors or ARBs caused reductions in~     the prognostically important parameters of arterial stiffness and LV mass. Because~     spironolactone therapy was also associated with significant falls in arterial pressure it~     remains possible that these effects were mediated simply by blood pressure reduction. In~     this multi-centre, randomised controlled study, the effects of treatment with spironolactone~     on LV mass and arterial stiffness in patients with stage 3 CKD on established ACE or ARB~     therapy will be compared to those of chlortalidone, a control anti-hypertensive agent. Early~     stage chronic kidney disease is highly prevalent and new, cost effective treatment~     strategies are required to reduce cardiovascular risk. This study is designed to provide the~     rationale for a larger study of morbidity and mortality with MRB therapy in early stage CKD.~   "
42345|NCT02502968|"~     This study evaluates the addition of BL-8040 to the standard consolidation therapy with~     cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants~     will receive BL-8040 and cytarabine in combination, while the other half will receive~     placebo and cytarabine.~   "
42346|NCT02502955|"~     Today complex vascular and cardiological interventions are performed in severely ill~     patients.~      Autopsy is the reference standard for quality control for almost two centuries, but autopsy~     rates for patients dying in hospitals are decreasing rapidly.~      Virtual autopsy has shown to be a good alternative for classic autopsy.~   "
42347|NCT02502942|"~     Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of~     the upper airway during sleep. OSA patients have a small upper airway that is kept patent~     during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g.~     genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in~     upper airway narrowing or collapse. Previous studies of upper airway muscle training showed~     variable results on OSA, but so far there has not been any practical, long-term, systematic~     upper airway muscle training developed or studied as the treatment of OSA. In theory,~     strengthening the upper airway muscle with exercise training in theory helps maintain a~     patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA~     muscle training can improve sleep apnea in some patients with OSA, including those already~     receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable~     therapy for a definable subset of OSA patients. Investigators hypothesize that patients with~     OSA who have mild or moderately compromised upper airway anatomy will benefit the most.~     3)There will be a positive association between the changes in muscle function and~     improvement in OSA severity.~   "
42348|NCT02502929|"~     The primary aim of the study is to compare the effect of three different interventions on~     lifestyle risk factors and biological risk factors for type 2 diabetes in depressed~     Cambodians. The three different interventions are lifestyle, lifestyle plus medication~     therapy management, and enhanced standard care.~   "
42349|NCT02502916|"~     The aim of this study is to evaluate the potential role of the enteral feeding systems on~     the bacterial colonization of premature infants during their NICU admittance and its~     evolution after 2 years, which is the age when the infant's gut starts to contain an~     adult-like microbiota.~   "
42350|NCT02502903|"~     Prospective, double-blind, randomized, placebo-controlled First-In-Human study with three~     sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs),~     Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in~     patients with a complement-mediated disorder.~   "
42351|NCT02502890|"~     Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness~     of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can~     sometimes make asthma symptoms worse. This study will help investigators learn about the way~     colds are related to asthma attacks among children who need higher amounts of medications to~     control their asthma. Investigators want to learn why viral colds sometimes cause asthma~     attacks and other times do not by studying the immune system response in samples taken from~     the nose and blood.~   "
42352|NCT02502877|"~     The present study is a pilot study aiming to compare the variation in core temperature~     (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial~     anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.~   "
42353|NCT02502864|"~     The purpose of this study is to adjust the amount of docetaxel participants receive based on~     the level of docetaxel measured in their blood. This method of dose adjustment is called~     pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of~     docetaxel using this method will lessen the side effects associated with docetaxel in cancer~     treatment.~   "
42354|NCT02502851|"~     The primary objective of this study is to evaluate the success of lesion preparation with~     either rotational atherectomy or cutting/scoring balloons as well as the long term effects~     of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients~     with complex calcified coronary lesions.~   "
42355|NCT02502838|"~     Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women~     undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are~     often associated with POP in 25-69% of patients and POP has been shown to be an independent~     risk factor for OAB. There is scientific evidence that surgical repair of POP reduces or~     eliminates OAB in >85%. In addition, stress urinary incontinence (SUI) is also often~     associated with POP, either clinically evident or as a potential post-operative~     complication.~      The clinical decision as to include a surgical technique to treat SUI when repairing POP~     surgically is still a matter of controversy. Most surgeons at the institution will include~     an extra procedure, specifically a retropubic sling, if SUI is clinically evident. Some will~     not include it unless there is urodynamic or clinical evidence of potential SUI~     post-operatively. Finally, some will include it regardless of clinical or urodynamic~     findings based on the apparent high incidence of such SUI after prolapse repair. The~     Tension-Free-Vaginal Tape (TVT) has been observed to reduce OAB as well as produce de-novo~     OAB symptoms, so the effect of TVT on OAB is still unclear.~      The purpose of this study is to determine the effect of additional TVT surgery on OAB~     symptoms in patients undergoing POP repair. It is hoped that such data will better determine~     the effect of either surgical intervention strategy on OAB symptoms. This is a prospective~     cohort study comparing patients with OAB that undergo surgical repair of their prolapse with~     or without additional TVT surgery. The outcomes will be measured using pre- and~     post-operative validated questionnaires (PFDI-20, OAB-q short form).~   "
42356|NCT02502825|"~     The purpose of this study is to compare the diagnostic validity (sensitivity and~     specificity) and evaluate the safety of 2-min Tidal Breathing methacholine bronchial~     provocation tests with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.~   "
42357|NCT02502812|"~     Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate~     (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose,~     three-way cross over, six sequence study to investigate the relative bioavailability of two~     75 milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1~     [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference~     product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be~     randomized, such that approximately 14 evaluable subjects complete the study. Total duration~     in the study for each subject will be approximately 8 weeks from screening to the follow-up~     visit.~   "
42358|NCT02502799|"~     Individuals with ADHD are at markedly high risk for increased substance use and Substance~     Use Disorder (SUD). Given the strong evidence for the negative trajectory of individuals~     with co-occurring ADHD and substance use initiation, the goal of this study is to conduct a~     controlled examination of a brief, early intervention (BEI) for substance modified for~     adolescents with ADHD. Importantly, this intervention will address individuals who are at~     risk for problems with substance use, but do not yet meet criteria for severe SUD.~      Although brief interventions have been found to be effective in other populations, their~     efficacy in an ADHD population with emerging risk for substance use problems remains~     uninvestigated. This study aims to understand why some adolescents with ADHD and elevated~     risk for SUD respond to (BEI) and others do not. The investigators will test whether~     situational and individual characteristics predict substance use development and response to~     treatment. Further, this study will assess which types of additional treatment are most~     effective for youth who do not respond to the initial BEI. It is hypothesized that rates of~     adolescent substance use will be lower among adolescents who participate in study~     treatments.~   "
42359|NCT02502786|"~     The purpose of this study is to find out what effect an antibody called Humanized 3F8~     (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in~     remission longer and/or prevent recurrence of the disease.~   "
42360|NCT02502773|"~     The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6%~     Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy~     is associated with a difference in morbidity and mortality within the first 14 days in~     patients at moderate-to-high risk of postoperative complications after abdominal surgery.~   "
42361|NCT02502760|"~     The purpose of this study is to determine if a program of physical activity, nutritional~     supplements and relaxation techniques is effective at decreasing post operative~     complications in frail colorectal cancer patients undergoing resection.~   "
42362|NCT02502747|"~     Study Objectives: To determine whether, in patients with large acute myocardial infarction~     undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim~     [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34,~     Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous~     infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement:~        -  in regional and global contractile function, myocardial perfusion and infarct size~          assessed by cardiovascular magnetic resonance.~        -  Echocardiographic parameters of LV function~        -  in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of~          myocardial damage and wall stress~   "
42393|NCT02502084|"~     3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means~     to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the~     sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic~     procedures.~   "
42394|NCT02502071|"~     The purpose of this study is to determine whether alkalinization of urine uric acid by 2~     doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization~     of urine uric acid over in adults with type 1 diabetes.~   "
42363|NCT02502734|"~     This study will be conducted to evaluate the effect of once daily treatment with fluticasone~     furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using~     knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive),~     will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the~     eligibility criteria will enter the 2 week run-in period. After completing run-in period,~     each subject will be randomly allocated to one of two treatment sequences: inhaled~     fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate.~     Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment~     periods will be separated by a two-week wash-out period. Subjects completing two treatment~     period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US~     for adults and adolescents aged 12 and above.~      ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.~   "
42364|NCT02502721|"~     A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate~     pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.~   "
42365|NCT02502708|"~     This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune~     checkpoint pathway indoleamine 2,3-dioxygenase (IDO), in combination with~     temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma~     model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation~     significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.~     This data provided the rationale for the companion adult phase 1 trial using indoximod~     (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open~     (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the~     clinic for children with brain tumors. This study will provide a foundation for future~     pediatric trials testing indoximod combined with radiation and temozolomide in the up-front~     setting for patients with newly diagnosed central nervous system tumors.~   "
42366|NCT02502695|"~     This is a research study for participants who have been diagnosed with lung cancer and are~     receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The~     overall objective of this study is to develop a database to collect data on participants who~     are undergoing VATS lobectomy or segmentectomy for lung cancer.~   "
42367|NCT02502682|"~     Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may~     present with profound diarrhea, especially in those patients receiving antibiotics. Based on~     a preliminary review of hospital data, the investigators have found that these symptomatic~     c. diff infections occur with a relatively high incidence at Delnor Hospital.~     Notwithstanding their high mortality, one recent study attributes a near quadrupling of~     hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple~     randomized trials to help reduce the incidence of highly virulent pathogens and hospital~     acquired infections. Further, several studies show a favorable effect of reducing the~     incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer~     studies, however, have focused on the effects of these baths on general medical/surgical~     wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine~     gluconate wipes in patients on the general medical/surgical wards who are exposed to~     antibiotics for a suspected or confirmed infection.~   "
42368|NCT02502669|"~     Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy~     and safety of once weekly, high dose oral finasteride compared to placebo for the treatment~     of severe nodulocystic acne in male subjects.~   "
42369|NCT02502656|"~     This study will evaluate the concordance of RAS mutation detection between the results~     obtained from circulating tumor DNA and those obtained with the standard method (testing~     from tumor tissue).~   "
42370|NCT02502643|"~     The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic~     surgery that air leak over 48 hours (2)The side effects and treatments of OK-432~     pleurodesis.~      [Methods] This study was a prospective, randomized, open-label, controlled study to evaluate~     the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection.~     The adult patient have persistent air leak >48 hours after thoracic surgery, will randomized~     to OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will~     be conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan~     University Hospital, a medical center. The study protocol was approved by the hospitals'~     Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic~     surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age> 20~     years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of~     continuous air leak. The exclusion criteria include: penicillin allergy,primary~     pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form,~     and pregnant or lactating, other serious concomitant illness such as uremia or liver~     cirrhosis. Study steps: eligible Patients will randomize according to computer-generated~     random numbers, with 1:1 ratio in sequentially numbered, sealed envelopes by a study nurse~     who was masked to the study. Randomization envelopes were opened, and randomization was~     performed by the study nurse after informed consent was obtain. Eligible inpatients were~     randomized to the OK-432 group or the normal saline (NS) group，each group are 40 cases.~      All subjects were observed by the physician who was masked to the study， about air leak stop~     time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function~     tests as necessary. cases if persistent air leak more than seven days, the attending~     physician determines whether pleurodesis again or surgery or other medical treatment.~     Finally, the researcher who do not know groups will collection data by air leak case record~     form including diagnosis, surgical site，the start and end time of the surgery, the use of~     antibiotics, discomfort problems (pain , stomach discomfort, cough, fever> 38 ℃, allergic~     reactions and respiratory discomfort), postoperative air leak time, air leak stop time ,~     chest tube removal time, discharge time, the data will be use SPSS20.0 version of the~     statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical~     methods for analysis.~      Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove~     time, length of hospital stay.~   "
42371|NCT02502630|"~     (MWA) is the most recent development in the field of local ablative therapies. The aim of~     this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and~     efficacy in pulmonary metastases from colorectal cancer.~   "
42395|NCT02502058|"~     The primary objective of this study is to determine if the use of a bone compaction process~     (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental~     implant sites, in human subjects, results in increased bone-ridge width, increased compact~     bone in the outer wall of the prepared sites, and dental implant stability.~   "
42396|NCT02502045|"~     Determine effect and duration of effect of timed therapeutic light compared to control light~     on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function~     in women with Alzheimer's Disease.~   "
42397|NCT02502032|"~     To investigate the effects of different doses of cisatracurium pretreatment on~     succinylcholine-induced fasciculations.~   "
46891|NCT02443506|"~     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus~     erythematosus. The study consists of a 21 day screening period followed by administration of~     the investigational product and up to 70 day follow up period.~   "
42372|NCT02502617|"~     In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are~     the direct consequence of malnutrition and adaptation to starvation and which are not. There~     is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are~     sequelae to the malnutrition. However, this consensus is largely based on experimental~     starvation studies of healthy subjects back in 1940s and from famine- and food programs in~     the third world, whereas evidence from studies on AN is lacking.~      The main objective of the study is in the detail to elucidate the short-term changes in the~     psychopathological profile, depression, anxiety, and cognitive functions in relations to~     intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical~     stabilization unit. Secondarily, it is examined whether cortisol levels are associated with~     depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an~     improvement in nutritional status over a short time leads to clinically significant~     improvements in psychopathology and cognitive functions, which remain 2-3 months after~     discharge, making the patients more accessible to psychotherapy.~   "
42373|NCT02502604|"~     Individuals with affective disorders (including post-traumatic stress disorder (PTSD) and~     major depressive disorder (MDD)) often experience declines in cognitive abilities such as~     memory and attention. Such difficulties can reduce functioning in important aspects of life,~     including at work or school. Little research has been conducted to investigate if cognitive~     dysfunction can be reduced in individuals with PTSD or MDD following a specific treatment.~     Thus, the investigators plan to determine the utility of a cognitive training program called~     goal management training (GMT) in reducing cognitive dysfunction in MDD/PTSD. GMT aims to~     assist participants in building skills in performing specific behaviours that rely on basic~     cognitive processes, allowing them to achieve an identified goal. 64 individuals with PTSD~     and 64 with MDD will be divided into two groups of 32, one GMT group, and one wait-list~     group that will receive GMT after study completion. The investigators predict that in~     comparison to the wait-list group, the GMT group will show greater improvements in cognitive~     functioning and everyday functioning following treatment and that these improvements will~     remain long-term.~   "
42374|NCT02502591|"~     Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent~     gynaecological condition. It is repaired by repairing and reinforcing the support to the~     vaginal wall at the back. A small cut is made through the lining of the back wall of the~     vagina. The supports to the rectum are reinforced with stitches and the bulging part of the~     vaginal wall cut away. The wound in the vagina is then stitched up. Rectocoele repair is~     usually carried under a general anaesthetic with women reporting moderate to severe degrees~     of pain post operatively on sitting down.~      A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for~     women who need an instrumental delivery during childbirth. It is also widely used during a~     range of surgical procedures (operations) as a preventive analgesia to help reducing post~     -operative pain. The investigators would like to see if using this technique during routine~     rectocele repair will help with post - op pain.~   "
42375|NCT02502578|"~     The purpose of this study is to assess the safety and to examine the index of the efficacy~     after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit~     cardiomyovasculopathy.~   "
42376|NCT02502565|"~     An observational study to evaluate the prevalence of US changes of gout in the joints and~     tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators'~     findings may support the extension of the spectrum of urate disease, and define a subset of~     patients that may benefit from early urate-lowering therapy.~   "
42377|NCT02502552|"~     Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on~     clinical factors (disease extension, perianal involvement, need for surgery, use of~     immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic~     role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have~     been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil~     cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the~     distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and~     their combined use has a sensitivity and a specificity of about 85%. However, 10 other~     antibodies have been identified and recently evaluated individually in IBD and especially in~     pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan~     (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate~     antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and~     anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These~     complementary tests improve the reliability of the diagnosis. In a previous cross-sectional~     work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of~     anti-glycan Abs and especially a correlation with a pejorative form of the disease both in~     Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in~     IBD.~   "
42378|NCT02502539|"~     Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint~     inflammation. The immune system disruption that leads to overproduction of pro-inflammatory~     cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels—some molecular,~     some cellular, and some systemic. Our objective is to identify the mechanisms through which~     physical activity is liable to mediate inflammatory balance in autoimmune disease settings,~     and specifically in JIA patients.~   "
42379|NCT02502266|"~     This randomized phase II/III trial studies how well cediranib maleate and olaparib work when~     given together or separately, and compares them to standard chemotherapy in treating~     patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after~     receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to~     grow while being treated with platinum-based chemotherapy drugs (platinum-refractory).~     Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed~     for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. It is not yet known whether giving cediranib maleate and olaparib~     together may cause more damage to cancer cells when compared to either drug alone or~     standard chemotherapy.~   "
42453|NCT02501304|"~     This is a prospective, multi-center, single arm, feasibility study to evaluate the safety~     and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep~     Apnea.~   "
42380|NCT02502253|"~     Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident~     dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic~     MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and~     thus represent a worthy target for secondary prevention interventions.~      There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes)~     increase risk of incident cognitive impairment and possibly AD, and evidence that the~     neurons of the AD brain are in fact insulin resistant with diminished glucose uptake under~     physiological conditions. Thus, persons with MCI and prediabetes may be at particular risk~     of incident cognitive impairment and AD.~      A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose~     does not improve cognitive (or other health) outcomes in older persons with peripheral~     insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI~     and metabolic risk factors, and a drug targeting insulin resistance with good~     blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While~     there is a phase III study of intranasal insulin targeting this strategy, nutraceuticals~     offer a low-tech solution that would be more suitable to future secondary prevention trials~     in MCI.~      Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of three nutraceutical~     preparations (grape seed polyphenolic extract [GSE], resveratrol, and Concord grape juice)~     that contain abundant concentrations of polyphenols. The investigators have found that oral~     BDPP administration was associated with improved cognition and brain plasticity (long-term~     potentiation [LTP]) in mouse models of metabolic syndrome and AD, as well as lowering brain~     amyloid and tau burden in an AD mouse model2-4. The investigators have demonstrated~     excellent absorption of oral BDPP in a small study in humans and similarly excellent CSF~     penetration of oral BDPP in rats, but it is crucial to demonstrate safety and CSF~     penetration of oral BDPP in humans to assess its potential as a treatment for MCI and~     prediabetes.~   "
42381|NCT02502240|"~     Evaluation of the frequency and clinical characteristics of ALK rearrangements in~     Latin-American countries.~      Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and~     exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated~     protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver~     has led to the development of novel therapies with activity in vitro and in the clinic.~   "
42382|NCT02502227|"~     This study is a three-arm randomized controlled trial of a mindfulness stress reduction~     intervention, with the aim of dismantling the experience-monitoring and~     nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment~     component. In addition to enhancing understanding of mechanisms underlying the effects of~     mindfulness interventions, identifying the therapeutic constituent(s) could inform~     development of targeted interventions as well as provide strategies to optimize adherence.~   "
42383|NCT02502214|"~     Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by~     multiplex PCR combining polymorphic microsatellites familial analysis and, where possible,~     couple-specific mutation detection. Single-cell multiplex PCR developments are costly and~     time-consuming. We propose to test and clinically validate a targeted next-generation~     sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for~     probably almost every couple asking for it in our centre, without a previous couple-specific~     development (but only a preliminary familial analysis). It will be based on haplotyping~     using a large number of SNPs and mutation detection. A clinical validation will be performed~     by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with~     couple's informed consent. Concordance of the results between PGD and reanalysis by NGS will~     be achieved and if validated, this technique may be applied to future PGD for cystic~     fibrosis in our centre. The same technique may then be applied for other PGD indications for~     which a set-up is often needed.~   "
42384|NCT02502201|"~     The purpose of this research study is to determine the effect of the environment on~     six-minute walk test performance in individuals with chronic obstructive pulmonary disease~     due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the~     environmental impact on physical performance in this population to determine if any factors~     influence quality of life. This study was developed to evaluate the efficacy of the using~     the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.~   "
42385|NCT02502188|"~     To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of~     CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.~   "
42386|NCT02502175|"~     Opioid-dependent patients seeking maintenance treatment will be recruited. Each participant~     will be allocated to one of the two study groups with the equal chance of receiving either~     opium tincture or methadone. Participants, clinical and research staff will not be aware of~     the medication that each patient receives. This study aims to test whether opium tincture is~     equally effective as methadone at retaining participants with opioid dependence in~     substitution treatment.~   "
42387|NCT02502162|"~     The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of~     complex regional pain syndrome (CRPS). Study participants will be randomly assigned to~     receive either LDN or placebo for a period of several weeks. During this period participants~     will be asked to come to several visits, which will include sensory testing, physical~     assessments, and questionnaires.~   "
42388|NCT02502149|"~     The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant~     coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of~     2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously~     treated participants with severe hemophilia A. The secondary objectives are: to characterize~     the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of~     treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial~     and a higher strength vial; and to evaluate the safety of rFVIIIFc manufactured at the 15K~     scale.~   "
42389|NCT02502136|"~     The purpose of this study is to assess the differences of safety and efficacy of carbon~     dioxide insufflation instead of air during sedated or unsedated endoscopy.~   "
42390|NCT02502123|"~     This study will prospectively assess long term heath related quality of life in chronic~     migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as~     standard of care.~   "
42391|NCT02502110|"~     The study will select all recruited patients with paroxysmal atrial fibrillation will be~     randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before~     ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the~     changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor~     necrosis factor (TNF)-α, and the changes of safety indicators .~      This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in~     patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in~     these patients who plan to undergo radiofrequency catheter ablation for consecutive 3~     months.~   "
42398|NCT02502019|"~     The primary objective of this pilot clinical investigation is to assess the reliability of~     the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of~     this clinical investigation are to collect initial data on the safety and efficacy of~     HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.~   "
42399|NCT02502006|"~     This research study will evaluate inter-individual variability in the response to the~     non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy~     adults. It will also investigate what factors, like age, sex, or genetic background, cause~     this variability.~   "
42400|NCT02501993|"~     The primary objective is to determine the early diagnosis rate and mortality rate of the~     Nasopharyngeal Carcinoma (NPC) in the study population.~      The secondary objective is to determine the incidence of NPC in the study population.~   "
42401|NCT02501980|"~     All participants in the selected communities will be tested for HBsAg by using serum~     samples. Among those who are positive for HBsAg, further clinical work-ups including AFP~     test and ultrasonography for liver exam will be performed. High risk group will be selected~     according to the definition. HCC diagnosis will be determined according to imaging and/or~     biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group~     and 3-years among HBsAg negative group.~      All subjects in the control arm (control communities) will be followed by record linkage to~     Cancer Register and Population Register.~   "
42402|NCT02501967|"~     The purpose of the proposed project is to pilot-test in the clinic setting a computer-based~     clinical decision support system (CDSS) designed to optimize medication prescribing for~     older persons with multiple chronic conditions and polypharmacy.~   "
42403|NCT02501954|"~     To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces~     the rate of recurrence when compared to sandwich therapy.~   "
42404|NCT02501941|"~     Hypothesis: Cortical spreading depolarizations are inhibited by the NMDA receptor antagonist~     Ketamine Aim 1: To demonstrate, in a group of patients with acute severe brain injury~     requiring surgery including traumatic brain injury and aneurysmal subarachnoid hemorrhage,~     whether use of continuous infusion of ketamine decreases frequency of occurrence of cortical~     spreading depolarizations.~   "
42405|NCT02501928|"~     The purpose of this study is to investigate the safety and tolerability of fesoterodine~     following once daily long-term treatment in Japanese pediatric neurogenic detrusor~     overactivity (NDO) subjects.~   "
42406|NCT02501915|"~     The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause~     sensory effects through the epidermis and dermis, generating a variety of physiological~     effects in other systems. Clinical effects are well known levels in muscle, neurological~     system, injuries, inflammation, edema, among other physiological effects are thus largely in~     the theoretical framework. Objectives: The aim of this study is to evaluate the~     Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility~     effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with~     six subjects in which they were divided into two groups, A and B. Group A received the~     application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both~     groups taped the non-dominant limb and the dominant limb was used as control group. The~     first application was conducted at 0% and the second with 75 to 100% tension. Evaluations~     were performed before the first application, immediately and 24 hours later. After this last~     evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated~     voltage and in sequence. The sixth last review was conducted 24 hours after this last~     application. Before every application a specific vibration was performed on the patellar~     tendon in order to trigger a neurophysiological imbalance rectus femoral.~   "
42407|NCT02501902|"~     This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety,~     pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in~     sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately~     30-60 patients are expected to be enrolled in the overall study.~   "
42408|NCT02501889|"~     This study investigates whether walnuts help to promote weight loss, associated with~     increased meal satiety and satisfaction, in 100 overweight and obese men and women who are~     participating in a 6-month behavioral weight loss intervention. Participants will be~     randomly assigned to a walnut-enriched reduced-calorie diet or a standard reduced-calorie~     diet. Body weight, risk factors for cardiovascular disease, and self-reported feelings~     relevant to satiety and appetite will be measured at baseline and 3- and 6-month follow-up.~     Also, the response of gastrointestinal tract hormones following meals with or without~     walnuts will be measured in a subset of study participants (n=20). Results from this study~     will contribute to understanding the role of nuts in weight control, including further~     knowledge of the mechanisms, and will expand knowledge of how nuts in the diet may~     contribute to the prevention and management of obesity.~   "
42409|NCT02501876|"~     In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an~     increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term~     mild cognitive impairment (MCI) describes a transition state between normal cognitive~     function and dementia. The annual rate of conversion to dementia in MCI patients is around~     15% in the general population, regardless of the presence or absence of diabetes. At present~     it is not possible to identify which patients with MCI are most likely to progress to AD. On~     this basis, the main objective of this study is to evaluate whether the presence of diabetes~     and or the presence of its related genes favors the conversion of MCI to AD.~   "
42410|NCT02501863|"~     The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with~     ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.~   "
42411|NCT02501850|"~     Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general~     population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective~     treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of~     CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to~     lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have~     demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp~     (a) in hepatocytes. The objective of the study is to test in humans the results observed in~     vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or~     Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.~   "
42412|NCT02501837|"~     The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social~     behavior and it has been recently shown that OXT also contributes to pair-bonding in men.~     However, it is still elusive whether OXT has similar effects in women. In the present study,~     the investigators examine the effect of intranasal OXT on behavioral ratings of and neural~     responses to the male partner in female participants. In a second experiment, the modulatory~     effect of OXT on emotion regulation is investigated.~   "
42413|NCT02501824|"~     Anthroposophic therapeutic speech is a complementary method that indirectly influences~     breathing and uses specific vowels, consonants, syllables and metres depending on the~     indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic~     speech in patients with asthma regarding clinical and physiological parameters, asthma~     control and quality of life.~   "
42414|NCT02501811|"~     This is a phase II, randomized, placebo-controlled clinical trial designed to assess~     feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells~     (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared~     to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by~     transendocardial injection in subjects with ischemic cardiomyopathy.~   "
42415|NCT02501798|"~     This study aims at investigating the direct effects of methylphenidate on school performance~     of primary school children. Although behavioral effects of this frequently prescribed drug~     are thoroughly studied (and confirmed), the effects of methylphenidate on school performance~     are less clear. Recent overviews indicate that effects are mainly quantitative and~     subject-specific. To gain more insight in this issue, the current double blind placebo~     controlled crossover study investigates not only the effects of methylphenidate on school~     performance but also it's effect on related variables such as short term memory, motivation~     and behavior. 60 children with ADHD are included and tested twice (with medication and with~     placebo) at their primary school.~   "
42416|NCT02501785|"~     The purpose of this study is to understand the level of caregiver burden related to caring~     for a patient who goes home within the first 24 hours following surgery. As the caregiver~     they are providing care to a family member, friend, or neighbor. Even when not formally~     trained, the care they provide is important to the patient's recovery. Providing care in~     this manner can be stressful. This study will help us understand what aspects of the~     patient's recovery are most difficult for the caregiver.~   "
42417|NCT02501772|"~     For diabetic patient with persisted albuminuria under the intensive control on blood~     pressure and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is~     easy to use and significantly effect on albuminuria reduction in patients of diabetic~     nephropathy.~   "
42418|NCT02501759|"~     This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy~     to see how well it works in identifying cancer in patients with suspected prostate cancer~     who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin~     needle inserted through the rectum into the prostate and takes a sample of tissue, guided by~     MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer.~     Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than~     standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy~     is more effective than ultrasound-guided biopsy in identifying prostate cancer.~   "
42419|NCT02501746|"~     Specific Aims: Bridging Income Generation with GrouP Integrated Care (BIGPIC) Over 80% of~     cardiovascular disease (CVD) deaths occur in low- and middle-income countries (LMICs).~     Diabetes, a major risk factor for CVD, is also responsible for substantial morbidity and~     mortality in LMICs. Elevated blood pressure (BP) increases CVD risk among individuals with~     diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk.~     Cost-effective, culturally appropriate, and context-specific approaches are critical. Two~     promising strategies to improve health outcomes are group medical visits and microfinance.~     Both can increase quality of care, clinician-patient trust, self-efficacy, health savings,~     self-confidence, group cohesion, and social support. While these strategies have been~     successful in other contexts, their impact on CVD risk reduction among diabetics and~     pre-diabetics in low-resource settings is not known.~      In partnership with the Government of Kenya, the Academic Model Providing Access to~     Healthcare (AMPATH) Partnership has expanded its clinical scope of work to include diabetes~     and hypertension. AMPATH has piloted group care and microfinance initiatives among patients~     with chronic diseases with promising early results. Both strategies are feasible, as is~     integration of group medical visits into microfinance groups. However, the effectiveness of~     these strategies individually, and in combination, on improving CVD risk is not known.~      Thus, the objective of this proposal is to utilize a transdisciplinary implementation~     research approach to address the challenge of reducing CVD risk in low-resource settings.~     The central hypothesis is: group medical visits integrated into microfinance groups will be~     effective and cost-effective in reducing CVD risk among individuals with diabetes and at~     increased risk for diabetes in western Kenya, and that the key modifiable CVD risk factor to~     be addressed is BP. The research team hypothesize that group medical visits and microfinance~     may each reduce CVD risk, but the integration of group medical visits and microfinance will~     yield the largest gains. Also further hypothesize is that changes in social network~     characteristics may mediate the impact of interventions on the primary outcome, and that~     baseline social network characteristics may moderate the impact of interventions. To test~     these hypotheses and achieve the overall objectives, the following specific aims will be~     pursued:~      Aim 1: Identify the contextual factors, facilitators, and barriers that may impact~     integration of group medical visits and microfinance for CVD risk reduction, using a~     combination of qualitative research methods: 1) baraza (traditional community gathering)~     form of inquiry; and 2) focus group discussions among individuals with diabetes or at~     increased risk for diabetes, microfinance group members, and rural health workers.~      Subsidiary Aim 1.1: Use identified facilitators and barriers to develop a contextually and~     culturally appropriate integrated group medical visit-microfinance model to reduce CVD risk~     among individuals with diabetes or at increased risk of diabetes. This model's acceptability~     and feasibility will be assessed by conducting focus group discussions with patients,~     microfinance group members, and health workers.~      Aim 2: Evaluate the effectiveness of group medical visits and microfinance groups for CVD~     risk reduction among individuals with diabetes or at increased risk for diabetes, by~     conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual~     clinical care plus microfinance groups only; 3) group medical visits only (no microfinance);~     and 4) group medical visits integrated into microfinance groups. The primary outcome measure~     will be one-year change in systolic blood pressure (SBP), and a key secondary outcome will~     be change in QRISK2 CVD risk score, which has been validated for Black Africans.~      Subsidiary Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in~     social network characteristics on intermediate factors and intervention outcomes and~     moderation analysis to evaluate the influence of baseline social network characteristics on~     effectiveness of interventions.~      Aim 3: Evaluate the incremental cost-effectiveness of each intervention arm of the trial, in~     terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per~     disability-adjusted life year saved.~      This research project will add to the existing knowledge base on innovative, scalable, and~     sustainable strategies for reducing CVD risk in diabetes and other chronic diseases in LMICs~     and other low-resource settings. If proven to be effective, the investigators are poised to~     expand the approach beyond the trial, thus ensuring that this research will have a~     significant and positive health impact on a larger population.~   "
42420|NCT02501733|"~     This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta~     GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data~     coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num:~     20141994) and randomized to the Sphere arm, will have their data utilized for this study.~   "
42421|NCT02501720|"~     Post burn flexion contractures are common in pediatric age group. Release of contracture and~     coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem.~     This procedure is routinely done under tourniquet control because bloodless operative field~     is essential to visualize important neurovascular structures in hand.~      Use of tumescent technique without a tourniquet is gaining acceptance because it avoids~     complications associated with tourniquet use, maintains a blood less surgical field and~     decreases operative time. Furthermore use of tumescent anesthesia often results in better~     surgical outcomes.~      Although the benefits of tumescent technique used in wide awake hand surgery are well~     documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement~     for pneumatic tourniquet for release of hand contracture in infants and adults under general~     anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement~     for a tourniquet in hand surgeries done under general anesthesia.~   "
42422|NCT02501707|"~     Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer~     patients, who are treated with curative chemoradiation. In this study the investigators want~     to evaluate the prognostic value of baseline cardiac function assessed with echocardiography~     for prediction of RILI.~   "
42423|NCT02501694|"~     Define responses to exercise on both arterial bruits and oxymetry in patients referred for~     suspected endofibrosis.~   "
42424|NCT02501681|"~     Single-centre prospective randomized study will be included the patients who undergo~     elective cardiovascular surgery. Preoperative fluid deficit will be calculated by the~     formula as starvation period X 4 X weight. Patients will be divided into two groups: Group A~     (n=20); crystalloid as priming solution used in patients, Group B (n=20); colloids as~     priming solution used in patients. In addition to priming solutions, extracorporeal pump~     will be filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard~     anesthesia protocol will be administered to all patients. Ringer's Lactate will be given at~     first 30 minute after induction. Ringer's Lactate as fluid maintenance will be administered~     at a rate of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management~     will be performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted~     %15.~   "
42425|NCT02501668|"~     The investigators will evaluate the prevalence of lung cancer associated with interstitial~     lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health~     Insurance Review and Assessment Service (HIRA) database, spanning the period from January~     2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of~     outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder~     (CTD), and COPD were identified based on the International Classification of Disease-10~     (ICD-10) diagnostic codes.~   "
42426|NCT02501655|"~     BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose~     compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to~     compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar~     scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled~     99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN~     (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb~     Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine~     distribution of deposition and mass balance between compartments.~   "
42427|NCT02501642|"~     The proposed study will address a very important issue for the VA both currently and in the~     future -- the high percentage of OIF/OEF/OND Veterans who have been medically diagnosed with~     a mild traumatic brain injury (mild TBI) and experience distressing symptoms. Smart phone~     mobile applications have become a primary source of information and communication among~     large percentages of Americans, especially those of the OIF/OEF/OND generation. The proposed~     study is a 4-year randomized control trial investigating the utility of an interactive,~     self-management smartphone application, TBI Coach, one of a suite of mobile applications~     developed by VA. The primary goal of the proposed study is to evaluate the efficacy of TBI~     Coach for improving clinical outcomes in those with a history of mild TBI and to determine~     what aspects of TBI Coach are most useful to Veterans. An overarching goal of this line of~     research is to improve access among Veterans with mild TBI who still have symptoms months to~     years after injury.~      Objectives. The study will pursue the following objectives:~        1. Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of~          TBI Coach.~        2. Determine the aspects of TBI Coach most associated with positive outcomes.~        3. Obtain qualitative information on factors associated with use of TBI coach or with~          deriving benefit from use of TBI Coach that can be used to inform future modifications~          of the application and wide scale implementation.~   "
42428|NCT02501629|"~     The primary objective of the study is to determine the ability of reslizumab administered sc~     to produce a corticosteroid-sparing effect in patients with oral corticosteroid~     (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.~   "
42429|NCT02501616|"~     This is a phase 4, single center, randomized, open-labeled, cross-over design study. The~     primary objective of the study is to compare effect of dapagliflozine and metformin on~     endothelial function.~      Subjects are randomized to initial metformin or initial dapagliflozin group and maintained~     initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained~     10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8~     weeks' cross-over is followed.~   "
42430|NCT02501603|"~     For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is~     a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks~     signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the~     transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of~     afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer~     patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for~     target enriched patients in gastric cancer.~   "
42431|NCT02501590|"~     Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is~     often used by occupational therapists as a way of developing fine motor control and visual~     motor integration in children. While there is anecdotal evidence to support this~     intervention, preliminary results in healthy children showed no differences in graphical~     quality while drawing on vertical or horizontal surfaces. This however was not investigated~     in children with graphomotor impairments.~      The goal of this study is to determine whether movements produced on a vertical surface~     differ in their performance level and muscle activation patterns compared to movements~     produced on a horizontal surface. The investigators predict that the level of performance on~     the vertical surface will exceed the level of performance on the horizontal surface.~     Additionally, the investigators hypothesize that the proximal muscles will be more activated~     and fatigued (in longer tasks) while drawing on the vertical surface, while the distal~     muscle will be more activated and fatigued while drawing on the horizontal surface.~   "
42432|NCT02501577|"~     Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position~   "
42433|NCT02501564|"~     Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and~     low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen~     sodium/codeine phosphate combination in these patients.~   "
42434|NCT02501551|"~     This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit~     mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease~     control rate (DCR), and the secondary end points are safety, response rate (RR), progression~     free survival (PFS), and overall survival (OS).~   "
42435|NCT02501538|"~     This is a pilot study. The investigators plan a cohort study of 10 patients with a diabetic~     foot ulcer (DFU). Study duration will be three weeks. Patients will be consented and undergo~     debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory~     Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue~     samples will be taken at this visit during standard of care wound debridement and these~     tissue samples of the wound would normally be removed as part of routine debridement. These~     tissue samples of the wound will be used for gene expression and bacterial~     analysis(research). The patient will then receive topical oxygen therapy using the TransCu~     O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used~     as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0)~     after routine wound debridement, and patient will receive instructions for home use of the~     device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a~     study window of 5 days., Digital photos of the wound, acetate tracing of the wound and~     vascular evaluations(SensiLase, Transcutaneous oxygen measurements, Hyperspectral imaging)~     will be performed at each study visit(research).Tissue samples will be taken during standard~     of care wound debridement at every study visit. Results of the data analysis from this~     project will be used to inform the design of a larger randomized clinical trial.~   "
47407|NCT02436525|"~     Microbial and periodontal changes associated with conventional versus self ligating~     brackets.~      The aim of this study will be to compare microbial and periodontal changes associated with~     conventional versus self ligating brackets.~   "
42436|NCT02501525|"~     This study will include patients aged between 18 and 70 who will undergo retrograde~     intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female)~     will be recruited, and will be randomized into 2 groups consisting of 40 patients in each~     group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS)~     positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of~     UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether~     using UAS or not affects the level of pain felt by patients in the postoperative period.~   "
42437|NCT02501512|"~     This study aims to extract and discriminate the signals of respiration, heart rate and~     swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric~     tube. These signals will be compared with the standard monitoring signals in the neonatal~     intensive care unit (NICU). Further, they will be used to search for objectively~     quantifiable maturational coordination processes of respiration, heart rate and swallowing.~     Lastly, this study aims to identify changes in ECG/EMG-signals as a result of external~     stimuli (e.g. nursing interventions) in the NICU.~   "
42438|NCT02501499|"~     This is an exploratory, qualitative evaluation study of the Breastfeeding Buddies (BFB)~     program. The Breastfeeding Buddies Program is a peer-based education and support program~     offered through the Kitchener Downtown Community Health Centre. The KDCHC has received~     funding to undertake a qualitative exploratory study of the BFB program. KDCHC has partnered~     with researchers at the Manulife Centre for Community Health Research at Wilfrid Laurier~     University to plan and implement this study.~      The purpose of the evaluation study is to understand the perspectives and experiences of~     Breastfeeding Buddies (BFB) participants and volunteers. The evaluation will explore the~     process of implementation of the BFB education and support programs and assess the program~     impacts from the perspective of participants and volunteers. The methods in this study are~     qualitative because the BFB program has never collected qualitative data from program~     participants and volunteers. In the past, evaluation of the program has been limited to pre~     and post surveys. This qualitative study includes two components:~        1. Interviews 6-8 weeks after the participants due dates with consenting mothers who~          participated in the Me Breastfeed workshop - 10-12 mothers who were matched with a~          Buddy (optional for all workshop participants) will be interviewed and 10-12 mothers~          who did not seek a match (but did participate in the workshop) will be interviewed to~          explore what they learned, what was helpful and how the program can be improved.~        2. One focus group with 10-15 Breastfeeding Buddies volunteers to explore the experiences~          and perspectives of the BFB volunteers.~   "
42439|NCT02501486|"~     Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA)~     axis caused by local corticosteroids, most often with inhalation corticosteroids. The exact~     prevalence is not known. Early recognition is important, because suppression of the HPA-axis~     can lead to significant morbidity and mortality. Suppression of the HPA axis might occur~     more often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to~     the local corticosteroid, a combination often used by human immunodeficiency virus~     (HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in~     diagnosis of suppressed HPA-axis.~      Research questions:~      Primary objective:~        1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis~          in HIV-treated patients?~           Secondary objectives:~        2. Are other variables associated with the HPA-axis suppression?~        3. Are cortisol measurements in hair as reliable as serum cortisol or an~          Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA~          axis? Study design: cross-sectional explorative study Study population: adults treated~          for HIV and using an inhalation or nasal corticosteroid.~      Intervention: an ACTH stimulation test, cortisol measurements in blood and hair.~      Main study parameters/endpoints:~      Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH~     stimulation test. Correlation between cortisol in plasma and hair cortisol.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Each person will be screened with a history and a short physical examination. A~     venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH~     stimulation test. An ACTH stimulation test has no major complications. A piece of hair is~     cut for cortisol hair analysis. The risks and burden are minimal, while the future benefits~     could be great since suppression of the endogenous HPA- axis can be associated with~     morbidities like hypertension or osteoporosis and can even lead to an adrenal crisis when~     the local corticosteroid is stopped.~   "
42440|NCT02501473|"~     This is a Phase 1/2 open label trial of G100 in patients with low grade NHL. G100 is~     composed of glucopranosyl lipid A in a stable emulsion and is a potent TLR4 (toll-like~     receptor-4) agonist. G100 will be administered by direct injection (intratumorally) into~     tumors of low grade NHL following standard low dose radiation therapy. Preclinical models~     and clinical studies in other cancers such as Merkel cell carcinoma have demonstrated that~     G100 administered in this manner can alter the tumor microenvironment, activate dendritic~     cells, T cells and other immune cells and induce systemic anti-tumor immune responses. In~     this trial, the safety, immunogenicity, and clinical efficacy of G100 will be examined alone~     or with pembrolizumab.~   "
42441|NCT02501460|"~     This study is being conducted because low lean muscle mass is prevalent among childhood~     cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the~     body's lean body mass. Low lean muscle mass is associated with loss of overall body~     strength, declining mobility and eventually, loss of independence. Among childhood cancer~     survivors, low lean muscle mass may contribute to reduced physical functioning and a sense~     of fatigue with exertion, limiting ability to participate in adequate physical activity.~     Loss of strength and a sense of fatigue with repeated movement make it difficult to~     participate in daily activities.~      Although there have not been exercise intervention studies among childhood cancer survivors~     specifically designed to evaluate the effects of resistance training on muscle mass, studies~     among individuals with chronic disease, including survivors of adult onset cancers, indicate~     that resistance exercise improves muscle mass, muscle strength, mobility, vitality and~     physical activity levels. Resistance training (weight lifting) is a form of physical~     activity that is designed to improve muscular fitness by exercising a muscle or a muscle~     group against external resistance.~      The purpose of the study is to evaluate the effects of resistance training combined with~     either a protein supplement or a sports drink on changes in lean muscle mass in young adults~     who were treated for childhood cancer. The sports drink, for this study, is considered a~     placebo.~   "
42464|NCT02501161|"~     This trial is conducted in Africa, Asia, Europe, North America and South America. The~     purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira)~     versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus~     inadequately controlled with oral anti diabetics.~   "
42465|NCT02501148|"~     The purpose of this study is to assess the safety and clinical performance of Paladin®~     system in patients with carotid artery stenosis.~   "
42442|NCT02501447|"~     Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an~     inherited blood disorder that afflicts about 100,000 people in the United States, and is~     among the most common lethal genetic diseases in the United States. Though worldwide in~     distribution, in the US it is most commonly found in African Americans. Its best known~     complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug~     treatment for SCD pain such as cognitive coping interventions have been shown to be~     effective for reducing SCD pain intensity, but they are complicated, multifaceted, and~     time-consuming. A simple and cost-effective alternative such as guided imagery (GI) could~     reduce the effect of stress on SCD pain. GI is an intervention where patients listen to and~     view audio-visual recordings while being directed to visualize themselves being immersed in~     that scene or scenario. There are no published studies on the use of GI as a simple stress~     coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.~   "
42443|NCT02501434|"~     A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose~     Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients~     with Significant Hemorrhage Burden.~   "
42444|NCT02501421|"~     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial~     that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L~     tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged~     18-50 years.~   "
42445|NCT02501408|"~     Evaluate a new porosthetic device in lower limb amputees.~   "
42446|NCT02501395|"~     Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive~     muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms,~     followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and~     bulbar muscles are also involved. However, the muscle involvement pattern has not been~     investigated systemically in Kennedy disease.~      The primary aim of the study is to investigate the muscle involvement in patients with~     Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as~     a potential outcome measure for future clinical trials in Kennedy disease.~      Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy~     voluntary controls will be recruited. The study consists of one visit per subject lasting~     4-5 hours.~   "
42447|NCT02501382|"~     The purpose of this study is to investigate the effects of hyperic oxygen treatment on the~     immune response in patients with necrotizing soft tissue infections~   "
42448|NCT02501369|"~     Cystic fibrosis (CF) is an illness that makes the lungs clog up with sticky mucus. There is~     no cure and so treatments are used to help make the illness easier to live with. The~     treatment can take lots of time and can feel not very nice sometimes. When children with CF~     become teenagers they need to learn to take charge of their treatment. This can be~     difficult. Teenagers with CF want to fit in with friends and can become more upset about~     their illness. Their parents have to learn to let their child take charge of their illness~     which can be hard for parents. These issues can put strain on parent-child relationships and~     this can make it harder for teenagers to stick to their treatment plans. A parenting program~     (called Teen Triple P) has been shown to help teenagers with other illnesses (such as~     diabetes) to be able to stick to their treatment plans. Parents are given a booklet to work~     through at home which helps them to build on the skills they already have. It aims to help~     families to support positive parent-child relationships, to manage difficult teenage~     behaviours, and to teach new skills and behaviours. So far no one has done any research to~     see if this program helps families of teenagers with CF. This research would like to see if~     the Triple P program can help teenagers with CF stick to their treatment plan. Helping~     teenagers stick to their treatment plan will help them to live happier and healthier lives.~   "
42449|NCT02501356|"~     To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the~     primary outcome measure of body weight and secondary outcome measures (hunger/satiety,~     health-related measures and self-reported quality of life) in a group of overweight but~     otherwise healthy adults.~   "
42450|NCT02501343|"~     The purpose of this study is to test the effect of increasing the body pH with an Alkaline~     agent (NaHCO3) on glucose homeostasis and insulin resistance in non diabetic subjects.~      The investigators aim to determine whether obese insulin resistant men on a typical Western~     diet with a high dietary acid load, have a blood pH in the low normal range, and whether~     administration of an alkaline agent for 4 weeks results in an increase in blood pH and an~     improvement in insulin sensitivity, as measured by the hyperinsuinaemic euglycaemic clamp.~      Secondly, the investigators aim to determine whether there is an acute reduction in blood pH~     following a typical Western (high acid load) breakfast in healthy men and women, and whether~     this effect is attenuated by the concurrent administration of an alkaline agent. The effect~     on glucose metabolism will also be assessed.~   "
42451|NCT02501330|"~     The objective of this surveillance is to collect information about~        1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)~        2. the incidence of adverse drug reactions in this surveillance~        3. factors considered to affect the safety and/or efficacy of this drug.~   "
42452|NCT02501317|"~     Introduction: Urinary incontinence is a condition that affects most women in her adult life;~     it is considered a public health problem and has a high negative impact on the quality of~     life. Physical therapy is considered as the first treatment option for this disease, these~     treatments are done with pelvic floor muscles exercises (kinesiotherapy) with or without the~     use of other resources such as biofeedback, electrical stimulation and vaginal cones.~     Rationale: The protocols used in the various studies on the treatment of urinary~     incontinence are made with only one type of therapy and have no change in the intensity of~     the exercises. The Active Perineal Rehabilitation protocol uses kinesiotherapy with~     biofeedback, electrical stimulation, vaginal cones and home exercises; it consists of 14~     individual sessions that gradually evolve the intensity of exercises. Objective: To assess~     the scientific validity of Active Perineal Rehabilitation protocol for the treatment of~     urinary incontinence. Methodology: A multicenter, prospective clinical trial, controlled and~     randomized, the sample will be divided into a study group that will be treated with the~     Active Perineal Rehabilitation protocol, and a control group will be treated with the~     protocol already widely used.~      Keys Words: urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum,~     conservative treatment~   "
42454|NCT02501291|"~     Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by~     relapse and progression. The incidence and prevalence of IBD are increasing in different~     regions around the world, indicating its emergence as a global disease. Though modern~     medical therapies including immunomodulators and biologic agents have revolutionized~     treatment of CD, the occurrence of steroids-dependence and resistance or intolerance to~     medical therapy is quite common. The limitation of present therapeutic management and the~     high expense of biologic agents leads to the treatment of CD become refractoriness. The~     occurrence rate of steroids-dependence and resistance or intolerance to thiopurine therapy~     is quite high during the course of CD. Approximately 38% of cases required surgery within 10~     years. Therefore, the management of such refractory CD remains a great therapeutic challenge~     for clinicians.~      Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor~     necrosis factor)-a- suppressing effects. The potential role for thalidomide in the treatment~     of refractory paediatric and adult CD has been investigated in more and more small~     open-label studies and retrospective case series. Recently, a randomized controlled trial~     showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term~     maintenance of remission in pediatric refractory CD. Gerich et al reported in a~     retrospective study that thalidomide improved long-term outcomes among 37 refractory CD~     adults followed up for a median of 58 months. However, the dose of thalidomide used in these~     studies ranged from 50mg/d to 150mg/d, and the occurrence rate of side effects reported~     variously but all quite high. The side effects related to the dose of thalidomide were the~     major concerns of using it in CD. Moreover, the effect of thalidomide on endoscopic response~     including mucosal healing which is a more objective and important outcome in CD was rarely~     reported. Therefore the aim of this study is to investigate the efficacy on clinical and~     endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD~     patients.~   "
42455|NCT02501278|"~     The aim of this study is to assess the potential benefit of the addition of immunotherapy~     with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and~     continued as adjuvant in patients with locally advanced cervical cancer.~      Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This~     safety run-in phase will include the first 3 patients treated in each of the two INO-3112~     combination arms who are exposed to at least two immunotherapy doses and evaluate whether~     the combination does not pose undue immediate risks to the patients further enrolled in the~     trial.~      Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant~     a further phase III conclusive trial based on progression free survival (PFS) at 18 months~     assessed by RECIST by the local investigator. The efficacy will be assessed within each~     experimental arm while the standard arm will serve as a reference arm to check the~     reliability of the results.~   "
42456|NCT02501265|"~     This study is designed to test an adaptive pharmacotherapy algorithm within the Duke Smoking~     Cessation Program (DSCP). The investigators hypothesize that patients treated in the DSCP~     with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher 12-week~     post-quit 30-day continuous abstinence.~   "
42457|NCT02501252|"~     Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and~     the majority of these deaths have been identified as being avoidable. A proxy indicator of~     Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan~     Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal~     deaths. The Ethiopia health system has established a vast network of health infrastructure~     that extends to rural areas with the establishment of over 15,000 health posts and~     deployment of over 30,000 health extension workers throughout the country. Although these~     unprecedented situations made health services more accessible than ever, it is yet to be~     exploited for improving rural women's access to clean and safe delivery and postpartum care.~     Lack of usage of delivery care in the country is related not only to accessibility but also~     acceptability of the services. In fact, the vast majority of women with home deliveries saw~     institutional delivery as unnecessary and a non-customary practice. Therefore,~     instituting an innovative, culturally sensitive, and practically amenable strategy,~     deployment of CORNs for example might be the best remedy, in this case.~      Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled~     Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural~     communities of Ethiopia.~      Study design: Cluster Randomized Controlled Community Trial that will be conducted in four~     phases.~      Study population: Study participants will be all pregnant women who will give birth at home~     and health facility (including health post) during the study period.~      Intervention: The study will be conducted in four phases as discussed below. During the~     first (preparatory) phase, sensitization of relevant stakeholders and recruitment of~     trainees will be conducted. In the second phase, formative and baseline assessment as well~     as training of CORNs will take place. In the third phase, which will be actual intervention~     phase, deployment of CORNs in their respective study site will be done and in the final~     phase, final evaluation and dissemination of study findings will be done. The intension~     behind deploying CORNs to the grassroots level is just to give a backup skilled delivery and~     other MNH services to poor rural mothers who have difficult of accessing modern health~     facilities for various reasons; it has no any intention to promote or encourage home~     deliveries or replace institutional deliveries. Perhaps it will help to assimilate rural~     mothers to modern health facilities Main study parameters/endpoints: The main study end~     point is percentage of skilled birth attendance which is very low in local and national~     level. In addition secondary study parameters are percentage changes of maternal & related~     services uptakes. These include focused Antenatal; care (ANC), long term family planning,~     Prevention of Mother to Child Transmission of HIV (PMTCT) and postnatal care.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: the burden and risks associated with participation to the study is very~     minimal. To mention few; physical examinations (Leopold manoeuvre) or the routine~     investigations of pregnancy this will be anonymous except for the CORNs keeping the~     principles of shared confidentiality in mind. Similarly all questionnaires or medical charts~     will be kept confidential. All CORNs will obtain intensive training on ethical principles~     that will help to minimize any physical and physiological discomfort associated with~     participation, the risks associated with the investigation treatment.~      The study period and Budget: the study will be carried out in a total of 18 months which~     holds a period from the development of protocol to the terminal evaluation and submission of~     reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine~     hundred eighty seven dollars and ninety five cents~   "
42458|NCT02501239|"~     The primary aim of this project is to conduct a randomized controlled pilot study evaluating~     the feasibility and potential effectiveness of a newly developed combined Health At Every~     Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!~     compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women~     (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two~     treatments. Depression, physical health, and other psychosocial outcomes will be assessed~     prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.~   "
42459|NCT02501226|"~     Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with~     greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will~     become the leading cause of disability in high-income countries. Notably, among patients~     with a previous experience of a major depressive episode, it was indeed estimated that up to~     85% of those patients will suffer from relapse. Two main factors were associated with a~     significantly higher risk of relapse: poor medication adherence and low self-efficacy in~     disease management. Interestingly, these issues could become the targets of~     psychoeducational programs for chronic diseases. Inded psychoeducational program for~     depression are recommended in international guidelines, but have not yet been proposed in~     France.~      Methods/Design: The investigators propose to evaluate the first French psychoeducational~     program for depression named ENVIE in a multicenter randomized controlled trial. Its aim~     is to educate patients on the latest knowledge on depression and effective treatments~     through didactic and interactive sessions. Patients will experiment the latest innovating~     psychological skills (from acceptance and commitment therapy) to cope with depressive~     symptoms and maintain motivation in behavioral activation. In total, 332 unipolar~     non-chronic (< 2 years) outpatients with moderate to severe depression, without psychotic~     features, will be randomly allocated to the add-on ENVIE program (N=166) or to a waiting~     list (N=166). The follow-up will last 15 months and include 5 assessment visits (enrollment,~     3, 6, 9, 12, 15 months).~      Discussion. If the proposed trial shows the effectiveness of the intervention, but also an~     increased remission rate in depressed outpatients at 15-months post-inclusion, in addition~     to improved treatment adherence in patients, it will further promotes arguments in favor of~     a wide dissemination of psychoeducational programs for depression.~   "
42460|NCT02501213|"~     While some authors recommend diuretics as the first treatment to initiate for symptoms~     caused by malignant ascites (MA), their prescription is variable. No randomized, controlled~     study has assessed their benefit in this context. According to literature, diuretics may~     bring relief in about 40% of cases, regardless of primary tumor.~      The purpose of our study is to assess the effectiveness of diuretic treatment according to~     Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the~     time elapsed between recurrent MA that requires paracentesis. The investigators will also~     examine whether SAAG and serum levels of renin and aldosterone can predict symptom response~     to diuretics.~   "
42461|NCT02501200|"~     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety~     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.~   "
42462|NCT02501187|"~     Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired.~     Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the~     levator aponeurosis. Treatment is surgical and can be performed by three common procedures -~     Levator advancement, Müller's muscle-conjunctival resection procedure and White line~     advancement. A number of reports inspected the possibility that Blepharoptosis repair~     procedures may cause deterioration in dry eye status. The investigators would like to assess~     whether there is a difference between the different procedures in their influence on dry eye~     status.~   "
42463|NCT02501174|"~     The aim of this study is to establish a common geriatric oncology medical database. The~     patients concerned are the patients having benefited from a geriatric oncology consultation~     in one of the participating centres. This database is designed with a view on the one hand~     to better describe to better understand this population and on the other hand to facilitate~     the conduct of future retrospective or prospective studies on this population. The~     constitution of this observatory of patients seen in consultation should facilitate the~     development of studies from the analysis of data collected, and occasional surveys by the~     rapid identification of cases. Data from this database could provide clinicians with~     valuable informative elements of descriptive epidemiology and concerning the organization of~     care in the geriatric oncology field.~   "
42467|NCT02501122|"~     The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric~     health information (PHIS) databases in addition to our own perioperative Nationwide~     Children's data base to look at outcomes, resource utilization, and cost trends for~     adenotonsillectomy in the nationally versus locally. The investigators also want compare~     Nationwide Children's to other regional and national tertiary pediatric institutions.~   "
42468|NCT02501109|"~     The purpose of this study is to compare the rate and extent of absorption of Aripiprazole~     Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male~     volunteers~   "
42469|NCT02501096|"~     This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in~     participants with selected solid tumors. Phase 1b will determine and confirm the maximum~     tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous~     [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e.~     non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial~     carcinoma, squamous cell carcinoma of the head and neck, or melanoma). Phase 2 (Expansion)~     will evaluate the safety and efficacy of the combination in 6 cohorts at the MTD from Phase~     1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).~   "
42470|NCT02501083|"~     Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and~     respiratory function may be affected in this group of diseases. The investigators sought to~     analyze the long term cardiac and respiratory function in patients with muscular dystrophies~     recquiring home mechnaical ventilation .~   "
42471|NCT02501070|"~     This is a multicenter retrospective observational study with STEMI (ST Elevation Myocardial~     Infarction) patients who have been treated in the northern Galician Hospitals. The study~     tries to verify if the implantation of the PROGALIAM (Galician Assistance Program Acute~     Myocardial Infarction) has supposed a progress in the quality and expectancy of life of AMI~     patients in the north area of Galicia.~      The study will recruit STEMI patients according to the third consensus definition of~     myocardial infarction type I.~      It will include all patients who meet these criteria regardless of other demographic or~     clinical circumstances. There is not exclusion criteria defined for this population.~   "
42472|NCT02501057|"~     The purpose of this study is to compare the effects of interventions for drinking-reduction~     and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The~     interventions consist of brief meetings to discuss drinking and ART adherence enhanced with~     daily self-monitoring through the use of a smart phone application that tracks drinking and~     other aspects of health. These meetings will either be based on the Clinician's Guide, a~     brief intervention for heavy drinking in primary care settings advocated by the National~     Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will~     be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of~     treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest~     among participants who receive the Clinician's Guide alone, intermediate among participants~     who receive the enhanced Clinician's Guide, and lowest among participants who receive~     enhanced Motivational Interviewing.~   "
42473|NCT02501044|"~     Hemodialysis patients may experience drops in blood oxygen saturation during the~     hemodialysis treatment, which may lead to hypoxia in the tissues.~      The investigators hypothesize that:~        1. The cumulative number, severity, or other characteristics of such deoxygenation~          episodes may be a predictor of adverse outcomes in hemodialysis patients.~        2. There may be demographic, anthropometric, clinical, treatment prescription, lab~          analytical, and other parameters that correlate with the number and severity of~          deoxygenation episodes and, therefore, may be used for risk stratification. Further,~          some of these parameters may be modifiable.~   "
42474|NCT02501031|"~     The purpose of this study is to understand whether consuming flaxseed for approximately 50~     days may beneficially affect the level of certain hormones in the blood thought to be~     involved in the development of breast cancer. This study will address the first steps toward~     the development of possible breast cancer prevention strategies. Differences in hormone~     levels (from blood samples) will be compared between two groups of women - those in the~     group assigned to eating ground flaxseed daily and those in the control group (with no~     change in diet).~   "
42475|NCT02501018|"~     A prospective, open label, controlled, randomized, double arm, multi-center study to assess~     the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to~     arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and~     potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).~   "
42476|NCT02501005|"~     The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular~     tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for~     congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation~     (VF) when compared to VT ablation after the third appropriate implantable~     cardioverter-defibrillator (ICD) shock.~   "
42477|NCT02500992|"~     Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained~     popularity. It is an appealing technique as a minilaparotomy in order to retrieve the~     specimen is avoided. Therefore less postoperative pain and a better cosmetic result are~     expected. The feasibility of the technique has been demonstrated.~      Still an open question is the risk of intraperitoneal contamination as in this procedure the~     colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened~     rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in~     order to fashion an anastomosis.~      In this study the bacterial contamination in the rectal stump as well as in the peritoneal~     cavity is assessed. The results are compared to bacteriological samples taken in a~     comparison group consisting of conventional laparoscopic assisted sigmoidectomies.~   "
42478|NCT02500979|"~     This study is designed to investigate the clinical efficacy and safety of pramlintide~     co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously~     via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the~     desired level of glycemic control using insulin therapy.~   "
42479|NCT02500966|"~     Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and~     amenorrhea. This study will test a new device named DUDA Device (Dispositivo Uterino para~     dilatar canal endocervical) placed just after the conization, in order to evaluate the~     safety, efficacy and quality of life.~   "
42483|NCT02500914|"~     This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer~     (SCLC) and large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate~     (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.~      The purpose of this study is to assess the safety and tolerability of SC-002 at different~     dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC~     and LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of~     SC-002.~   "
42484|NCT02500901|"~     This is a phase I study to determine the safety and feasibility of the combination of~     enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer~     (CRPC).~   "
42485|NCT02500888|"~     The aim of this study is to evaluate, through a pilot study with about ten cases, if~     bilateral ventral capsulotomy by linear accelerator enable modification of~     obsessive-compulsive symptoms and quality of life in patients with severe and refractory~     obsessive compulsive disorder (OCD) and also investigate possible adverse effects /~     complications of the procedure.~   "
42486|NCT02500875|"~     The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN~     therapy without instillation in the treatment of infected surgical wounds. Investigators~     mean to verify differences of effectiveness between the different types of instilled~     substances, normal saline versus Amukine Med 0.5%.~   "
42487|NCT02500862|"~     Characterize potential biomarkers of sight-threatening eye diseases based on the information~     acquired in clinical practice at CEC, AIBILI~   "
42488|NCT02500849|"~     The purpose of the study is to evaluate the safety and feasibility of administering~     SB-728mR-HSPC after conditioning with busulfan.~   "
42489|NCT02500836|"~     Randomized, prospective, multi-center, double blind placebo-controlled parallel group study~     of a Placebo Topical Solution versus Cocaine HCl 4% Topical Solution for safety and~     efficacy, and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a~     diagnostic procedure or surgery on or through accessible mucous membranes of the nasal~     cavities. Both domestic (United States) and foreign sites are eligible, and both inpatient~     and outpatient settings are eligible.~   "
42490|NCT02500823|"~     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,~     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with~     the initiation and development of cardiovascular disease. This study was undertaken to~     investigate whether mtDNA copy number in peripheral blood cells could be used as a risk~     predictor for coronary heart disease.~   "
42491|NCT02500810|"~     The purpose of this study is to determine whether monosialoganglioside are effective in the~     prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer~     patients, and improve the quality of life of patients.~   "
42492|NCT02500797|"~     This randomized phase II trial studies how well nivolumab with or without ipilimumab works~     in treating patients with sarcoma that has spread from the primary site to other parts of~     the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and~     ipilimumab, may block tumor growth in different ways by targeting certain cells. It is not~     yet known whether nivolumab works better with or without ipilimumab in treating patients~     with metastatic or unresectable sarcoma.~   "
42493|NCT02500784|"~     The purpose of this study is to test the effects of long-term therapeutic doses of~     formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42~     levels in the CSF, and b) cognitive function in people with mild to moderate Alzheimer'~     Disease (AD).~   "
42494|NCT02500771|"~     This is a project to be funded by a Fast-Track Small Business Innovative Research to build~     and test the feasibility of a new software prototype called V-Motive which will facilitate~     the combination of two proven autism behavioral interventions: Applied Behavior Analysis~     therapy (ABA) and Video Modeling (VM). The investigators will conduct a Phase I feasibility~     analysis and Phase II pilot study of the V-Motive Prototype by observing a community therapy~     providers' use of the prototype in a therapy setting. Investigators will observe the users~     and record the success or failure of the performance of key functions of the software.~     Investigators will also administer surveys. The study will answer research questions about~     V-Motive's ability to perform its intended function: allowing interventionists to feasibly~     leverage video modeling within ABA therapy with a minimal amount of overhead and labor.~   "
42495|NCT02500758|"~     Despite the wide variety of products and antiseptic agents, no agent is ideal for every~     situation. The investigators would like to evaluate the difference in reducing bacterial~     load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative~     surgical scrubbing.~   "
42496|NCT02500745|"~     After obtaining a consent, bed side cardiac ultrasonography will be performed for cases~     undergoing transesophageal echocardiography to evaluate the correlation between left atrium~     volume and left atrial appendage flow velocity which can predict the thrombosis risk.~   "
42497|NCT02500732|"~     Objective: To determine if atomoxetine 40 mg bid in patients ≥18 years old with recurrent~     vasovagal syncope will better prevent syncope during tilt testing than placebo.~   "
42498|NCT02500719|"~     The purpose of the current study is to develop a better understanding of the brain~     mechanisms involved in psychological treatments for posttraumatic stress disorder (PTSD).~     This project will build on past research using script-driven imagery in our lab by~     investigating brain activity in areas activated during exposure to trauma-related cues. This~     project will also develop new knowledge concerning volitional control of those areas. The~     ultimate goal of this study is a better understanding of whether volitional control of these~     brain areas will improve therapeutic outcomes. This process will first be piloted in a~     sample of healthy controls. This will allow investigators to refine the methodology prior to~     recruiting a sample with PTSD.~   "
42499|NCT02500706|"~     This trial is conducted in Asia, Europe and North America. The purpose is to confirm~     efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin~     aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.~   "
42528|NCT02500329|"~     This is a phase 4, single center, randomized, open-labeled study. The primary objective of~     the study is to compare effect of gemigliptin and acarbose on endothelial function.~      Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for~     4 weeks.~   "
42500|NCT02500693|"~     This trial is intended to evaluate the value of circulating tumor cells (CTC), in~     combination with unenhanced (without injection of contrast media) low dose (to limit the~     effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of~     Lung cancer (LC).~      LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55~     years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of~     false positive that require repeat follow-up and also invasive investigations, but also~     false negatives with metastatic LC being discovered between screening rounds.~      Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and~     characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET~     technique in a population at high risk for LC, i.e. COPD patients before LC was detectable~     on LDCT.~      The study will focus on patients at very high risk for lung cancer i.e. smokers and~     ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).~      The study will enroll 600 participants who will undergo three rounds of screening at one~     year intervals, each round combining search for CTC on a blood sample and LDCT. Each~     participant will be followed for at least one year after the last screening round~   "
42501|NCT02500680|"~     The purpose of this study is to evaluate the safety, tolerance, and immunogenicity of~     MAS-1-Adjuvanted seasonal inactivated influenza vaccine (IIV) (MER4101) with hemagglutinin~     dose escalation compared to non-adjuvanted comparator IIV standard dose (SD) in healthy~     adults and high dose (HD) IIV in ambulatory elderly subjects.~      Hypothesis: Reduced hemagglutinin (HA) dose IIV formulated in MAS-1 adjuvant (MER4101) is~     safe, tolerable and immunogenic in healthy young adults 18 - 49 years of age compared to SD~     IIV and an optimal dose of HA formulated in MAS-1 adjuvant will be safe and immunogenic in~     adults who are 65 years of age and older compared to HD IIV (from Phase 1A, known to be 9µg~     of HA antigen).~   "
42502|NCT02500667|"~     The present study is designed to assess the effects of Rifampin on the pharmacokinetics of~     N91115 in healthy subjects.~   "
42503|NCT02500654|"~     The purpose of the study is to evaluate if surgical treatment of peri-implantitis with~     enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing~     outcome, changes in the peri-implant microflora and on the inflammatory response in the~     periimplant pocket at 12 months.~   "
42504|NCT02500641|"~     Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after~     36 weeks of treatment.~   "
42505|NCT02500628|"~     Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to~     familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated~     with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will~     provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then~     provide an additional sample 2 hours later.~   "
42506|NCT02500615|"~     This study examines the acute effects in ECIG users of the two primary vehicles in ECIG~     liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an~     ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin~     ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid~     nicotine concentration, puff number, and interpuff interval all will be held constant).~     Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in~     each condition.~   "
42507|NCT02500602|"~     The proposed study will examine the efficacy of doxazosin XL in the treatment of PTSD and~     alcohol use disorders.~   "
42508|NCT02500589|"~     Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that~     increase successful quit attempts among depressed smokers with chronic medical illnesses are~     particularly important for the VA healthcare system because rates of tobacco use,~     depression, and chronic medical illnesses are significantly higher among Veterans compared~     to the general population. Providing smoking cessation services augmented with mood~     management to Veterans via telephone may increase access to, and utilization of,~     evidence-based smoking cessation counseling and decrease rates of smoking-related~     complications for Veterans with chronic medical illnesses and depression. Yet, the reach of~     smoking cessation telephone counseling has been limited among populations with mental~     illness. The investigators intend to combine the potency of co-delivered mood management and~     reach of telephone-delivered interventions by testing the telephone delivery of behavioral~     mood-management for smoking cessation among smokers with depression and chronic medical~     illness.~   "
42509|NCT02500576|"~     The goal of this clinical research study is to learn if pembrolizumab, an infusion of~     T-cells, chemotherapy (cyclophosphamide and fludarabine), and either high or low dose~     interleukin-2 (IL-2) can help to control metastatic melanoma. The safety of this drug~     combination will also be studied.~      T-cells are white blood cells in your body that are important to the immune system. The~     T-cells used in this study will be collected and grown in a separate study (MD Anderson~     Protocol 2004-0069)~   "
42510|NCT02500563|"~     This clinical trial will evaluate the stool of infants fed one of two infant formulas, which~     contain different types of proteins, or breast milk to determine if different proteins have~     an effect on the type of bacteria that enters and lives in an infant's intestine early in~     life.~   "
42511|NCT02500550|"~     The purpose of this study is to determine whether a repeat dose administration of ATIR101 is~     safe and effective when infused in patients with a hematologic malignancy following a T-cell~     depleted stem cell graft from a related haploidentical donor. All patients are planned to~     receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or~     halted for safety reasons.~   "
42512|NCT02500537|"~     A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.~   "
42513|NCT02500524|"~     To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%)~     in the eradication of head lice. To assess the ability of each product to kill all viable~     ova and to assess patient acceptability of the product in use.~   "
42529|NCT02500316|"~     Protocol CP-4-004-EXT is designed as an open-label extension study assessing long-term~     MOD-4023 administration. It is open to subjects completing Phase 2 study in children with~     growth hormone deficiency (CP-4-004).~   "
43157|NCT02492100|"~     This research study is evaluating the feasibility and impact of an intervention to improve~     sexual function in stem cell transplant survivors on participants' sexual function, quality~     of life, and mood.~      - It is expected that about 50 stem cell transplant survivors will take part in this~     research study.~   "
42514|NCT02500511|"~     To determine the persistence of protective antibody levels for subjects who seroconverted~     after vaccination with NmVac4-A/C/Y/W-135-DT™~      Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be~     contacted and asked to provide a blood sample at 12-24 months after vaccination with~     NmVac4-A/C/Y/W-135-DT.~      Serum Bactericidal Assays will be performed to evaluated duration of protective antibody~     titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who~     seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24~     months after vaccination.~   "
42515|NCT02500498|"~     The study is a retrospective cohort study that utilizes medical records from the BiologicTx.~     Data accrual starts upon initial home infusion nurse visit until the most recent home~     infusion nurse visit. Infusion related adverse events are quantified as number of patients~     with adverse event over the total number of patients and number of event over total number~     of home infusion visits.~   "
42516|NCT02500485|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.~   "
42517|NCT02500472|"~     This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to~     assess whether kava can alter NNK metabolism in humans.~   "
42518|NCT02500459|"~     Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this~     study is to determine if treatment with topotecan by an alternative method, direct delivery~     into the part of the brain where the tumor has spread, is safe and well tolerated. The~     Cleveland Multiport Catheter is a new, investigational device that will be used to deliver~     topotecan into tumor-infiltrated brain. A second purpose of this study is to determine~     whether the Cleveland Multiport Catheter can be used effectively and safely to deliver~     topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to~     treatment with topotecan. This study will also look at the way topotecan is injected into~     tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be~     added to topotecan before it is injected. Pictures will be taken of the brain with an MRI~     machine. This will allow the investigators to see where in the tumor-infiltrated brain the~     topotecan has been injected. This study will collect medical information before, during, and~     after treatment in order to better understand hot to make this type of procedure accessible~     to patients.~   "
42519|NCT02500446|"~     Several studies have suggested that despite suppressive combination antiretroviral therapy~     (ART) in people who are HIV-positive, in some individuals there may be on-going viral~     replication. Clarifying the extent of on-going viral replication on ART is important for the~     development of HIV-1 curative strategies and for reducing HIV-1 associated immune~     activation. The investigators hypothesize that treatment intensification with dolutegravir~     will inhibit residual virus replication in HIV-1 infected patients on ART. The primary~     objective of this study is to determine the effects of dolutegravir intensification on~     residual virus replication in circulating cluster of differentiation 4 (CD4+) T cells.~   "
42520|NCT02500433|"~     OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor~     control compared with conventional therapy in children with cerebral palsy (CP).~      METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional~     intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3)~     assessment were performed. Experimental intervention was based on videogames treatment~     (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills~     were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the~     Pediatric Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and~     jumping capacity by the Gross Motor Function Measure (GMFM).~   "
42521|NCT02500420|"~     Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic~     cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the~     left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an~     important heterogeneity of prognosis and clinical expression going from a asymptomatic state~     until the devastating sudden death occurring in a young person.The diagnosis of HCM is~     definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial~     history).This hypertrophy is often accompanied by other abnormalities detected by~     echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral~     regurgitation …Now, the current challenge is to determine the prognosis factors of the~     disease that could help to identify the patients with high risk of sudden death. Some~     prognosis factors are knowed and used in the calculation of a new risk score. This risk~     score allows to estimate the risk of sudden death at 5 years and propose depending on the~     result, the implantation of a defibrillator for primary prevention.The physiopathological~     mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a~     major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas~     where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it~     can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading~     to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized~     as an important mechanism of the disease evolution. Acute ischemic events could be a trigger~     of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function~     is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis~     appears at a very advanced stage of the disease. Exercice stress echocardiography permits to~     detect myocardial ischemia caused by microvascular dysfunction in the HCM before the~     fibrosis apparition. Moreover the investigators suggest to study the deformation parameters~     by speckle tracking or 2D strain witness of a contractile LV dysfunction before the~     apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as~     the more sensible technique to identify focal myocardial fibrosis resulting in areas of late~     gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with~     the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is~     detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with~     the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show~     inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new~     hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some~     studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas~     without LGE which reflects the presence of new fibrosis.The objective of study is to compare~     these two imagery techniques in order to detect ischemia and fibrosis. These techniques are~     usually used in the diagnosis or the monitoring of the disease. The investigators propose to~     realize an exercise stress echocardiography to study: the segmentary kinetic of the left~     ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the~     T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease~     (although not yet involved in the calculation of the risk of sudden death) and need to be~     study in each MRI realized for HCM. From the same way, the investigators suggest to follow~     patients to determine if the abnormalities detected by these two techniques and particularly~     2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are~     prognosis factors of the disease and appear more precociously than LGE.~   "
42522|NCT02500407|"~     This study is designed to evaluate the safety and pharmacokinetics of BTCT4465A when~     administered as a single agent by intravenous (IV) infusion to participants with relapsed or~     refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an~     expansion stage where participants will be enrolled into indication-specific cohorts.~   "
42523|NCT02500394|"~     This study evaluates the impact of a biomarked guided intervention on the development of~     acute kidney injury in high risk surgical patients. Eligible patients are screened for~     marker of tubular stress in the urine; if patient specific results are above a pre-defined~     cutoff they are randomized into a standard care group or an interventional group in which~     patients receive intensified volume therapy.~   "
42524|NCT02500381|"~     The main objective of this study is to evaluate the efficacy of SRP-4045 and SRP-4053~     compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame deletion~     mutations amenable to skipping exon 45 and exon 53 respectively. Additional objectives~     include evaluation of safety, pharmacokinetics and biomarkers.~   "
42525|NCT02500368|"~     This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test~     lens against the control lens.~   "
42526|NCT02500355|"~     Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under~     Endoscope.~   "
42527|NCT02500342|"~     Thyroid hormone is a key regulatory hormone for a range of physiological systems. An~     impaired function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect~     quality of life. Older adults with subclinical hypothyroidism often report non-specific~     symptoms such as tiredness. In addition, muscle symptoms such as cramps, weakness and~     myalgia are more common in SCH than in healthy controls. At present, evidence is lacking~     about the benefits of thyroxine replacement in the elderly with SCH, as no large randomized~     clinical trials (RCT) on the full range of relevant clinical outcomes, including tiredness~     have been performed. Moreover, there is continued uncertainty about the long-term impact on~     health related quality of life of thyroxine treatment for SCH. The aim of the study is to~     examine, within a large RCT of elderly participants with subclinical hypothyroidism, the~     impact of thyroxine therapy on the association between subclinical thyroid disease (SCTD)~     and the level of physical and mental fatigue. The existing trial infrastructure (TRUST~     thyroid trial-Euresearch FP7; clinicaltrials.gov ID: NCT 01660126) will be utilized to~     collect information on the level of physical and mental fatigue by using the Pittsburgh~     Fatigability Scale at baseline and at 1 year from 220 participants with persistent~     subclinical hypothyroidism randomized to either thyroxine or placebo.~   "
42530|NCT02500303|"~     The purpose of this study is to explore the factors that influence limb fitting in those~     with diabetes compared to those without diabetes. The population without diabetes will~     usually present with peripheral arterial disease (PAD) and are similar in management~     following LEA. The impact that not walking with a prosthesis has long term on both~     populations will be explored. In general, previous research has used retrospective analysis~     of case notes which, although valuable, have fixed fields and only allow the researcher to~     look at associations between factors not at causation. Additionally, very few have followed~     a population over time. Therefore this study will be a prospective observational analysis of~     all those who undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow~     & Clyde area with follow up at 6, 12 & 18 months from date of amputation.~   "
42531|NCT02500290|"~     This study aims to describe antiplatelet therapy in ACS in Andalusia and make an assessment~     of efficacy and safety of hospital use Prasugrel / ticagrelor vs. Clopidogrel and Prasugrel~     switching to / ticagrelor patients pretreated with clopidogrel.~   "
42532|NCT02500277|"~     This is a prospective study to assess the yield of pleural biopsy obtained with the routine~     flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during~     semirigid thoracoscopy~   "
42533|NCT02500264|"~     The aims of the study: To evaluate whether the use of a specific TENS technology can improve~     GERD symptoms and esophageal acid exposure.~   "
42534|NCT02500251|"~     This study is a prospective, open label, phase I/II pilot study.~   "
42535|NCT02500238|"~     Electronic cigarette use may be less harmful than cigarettes in adults, however, limited~     data exists examining passive electronic cigarette exposure and child health outcomes. The~     current study seeks to compare health-related outcomes among youth who reside with~     non-smokers, cigarette smokers, and electronic cigarette users. The investigators propose to~     conduct a small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10~     parent-child dyads will be recruited: 1) control group: parents who are~     non-smokers/non-vapers, 2) smoking group: parents who are exclusive cigarette smokers, and~     3) vaping group: parents who are exclusively ECIG users. Groups will be compared across the~     following variables: child lung function and biomarkers of nicotine.~   "
42536|NCT02500225|"~     The purpose of the study was to investigate the effects of etomidate or sevoflurane used in~     electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery~     profiles.~   "
42537|NCT02500212|"~     Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of~     ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney~     transplant patients.~   "
42538|NCT02500199|"~     Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum~     tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2~     (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other~     solid tumors that have no targeted agent as standard of care).~      Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive~     metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at~     the RP2D (or MTD).~   "
42539|NCT02500186|"~     The objectives of this clinical study is to assess the effect of the amount of carbohydrate~     intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus~     treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from~     renal uriniferous tubule, on glucose variability by using continuous glucose monitoring~     (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients~     treated with SGLT2 inhibitors. In addition, blood and urine samples are collected for~     metabolome analysis that will be performed as an extension study of the clinical study.~   "
42540|NCT02500173|"~     To collect and analyze effects and side effects in patients undergoing radiotherapy.~      This study investigates how analysis of effects and side effects will influence outcome of~     patients. These retrospectively collected data allow to adapt and improve radiotherapy~     treatment regimens .~   "
42541|NCT02500160|"~     Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA)~     as a new technology for improving accuracy in restoration of the alignment and biomechanics~     of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to~     the patient's anatomic configuration of distal femur and proximal tibia based on~     preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and~     CT-based PSI systems are available from various manufacturers for preoperative planning. MRI~     offers precise visualization of articular cartilage without the risk of radiation exposure,~     but it is expensive and requires long scan times. In contrast, CT enables accurate~     identification of the contour of the femur and tibia at short scan times, but it does not~     provide information on the cartilage thickness and carries the risk of radiation exposure.~     As a result, there is a possibility of some discrepancy between the thickness of bone~     resection proposed by MRI- or CT-based PSI system and the actual thickness of bone cut.~     Although PSI has been the focus of study in many recent researches, there has been no~     clinical study comparing MRI-based and CT-based PSI systems in preoperative planning.~     Therefore the investigators questioned whether the MRI-based PSI that reflects the cartilage~     layer would provide more precision in TKA than the CT-based PSI. The purpose of this study~     was to investigate the accuracy of MRI-based PSI and CT-based PSI in predicting bone~     resection thickness in TKA.~   "
42551|NCT02500030|"~     Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity~     (MIC), which contributes to increased morbidity and mortality from respiratory diseases.~     Techniques such as glossopharyngeal breathing (GPB) and insufflation using a manual~     resuscitation bag, or air stacking (AS), can be used to increase the MIC. These techniques~     employ different mechanisms, and the ability to learn the technique plays a key role in its~     proper implementation and effectiveness. The objective is compare the effects of AS and GPB~     on the MIC in patients with NMD.~      Children and adolescents with NMD who were users of non-invasive mechanical ventilation were~     recruited. Vital capacity (VC) and MIC were measured prior to and after the intervention~     with AS and GPB. Values were compared pre- and post-intervention and were considered~     statistically significant if p <0.05.~   "
43158|NCT02492087|"~     The objective of this study is to investigate whether topical application of tranexamic acid~     into the uterine cavity and the surgical site intra-operatively can reduce blood loss and~     provide better surgical haemostasis in parturients with moderate to high risk for bleeding~     undergoing caesarean deliveries.~   "
42542|NCT02500147|"~     This project, A double-blind placebo-controlled randomized clinical trial assessing the~     efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary~     syndrome, proposes exploring the use of novel and noninvasive methodologies in an at-risk~     adolescent and young adult population with polycystic ovary syndrome (PCOS) who may gain~     long-term health benefits from early detection and treatment of non-alcoholic fatty liver~     disease (NAFLD). PCOS is a common condition that frequently presents in adolescence and~     young adulthood and is defined by elevated androgens (male hormones) in the blood leading to~     1. hirsutism and acne and 2. menstrual abnormalities or amenorrhea. Affected individuals are~     at increased risk of developing insulin resistance (a precursor of diabetes), NAFLD and~     lipid (cholesterol) abnormalities.These features are all associated with the metabolic~     syndrome, a rising major public health concern. Recently, an association between PCOS and~     NAFLD has been noted but has only been superficially studied in the adolescent and young~     adult population. The susceptibility of certain PCOS patients to developing NAFLD is~     theorized to be due to having underlying insulin resistance, elevated androgen levels, and a~     genetic predisposition. Metformin is an insulin sensitizing medication widely used to treat~     type 2 diabetes mellitus that may have beneficial effects on insulin resistance-related~     conditions including PCOS and NAFLD. Although widely used in PCOS, its effect on NAFLD in~     this group has not been previously studied.~      The primary aims of this proposal are: 1) To determine whether PCOS with liver fat >/=4.8%~     treated with metformin for six months will have a decline in percentage liver fat compared~     to a placebo group. 2) To measure the association of the PNPLA3 I148M allele with NAFLD in~     PCOS at baseline (n=40). 2b) To measure the association of percentage liver fat with~     biomarkers of NAFLD, dyslipidemia, insulin resistance and body composition at baseline~     (n=40) and after a placebo-controlled intervention with metformin in PCOS with liver fat~     >4.8% (n=20).~      The goal of this research proposal is to explore the use of novel and noninvasive~     technologies in a young and at risk population. Dr. Sopher hopes to use the results of this~     research to lay the groundwork for the prevention and treatment of NAFLD and other metabolic~     disorders in adolescents and young adults with PCOS and to prevent lifelong morbidity~     associated with PCOS.~   "
42543|NCT02500134|"~     The limbus located between the cornea and the conjunctiva tissue, is important for not only~     providing a barrier frontier to prevent conjunctival tissue invasion into the cornea,~     containing nerves passing to the cornea, having blood and lymph vasculature for oxygen and~     nutrient delivery, but also the niche environment of limbal stem cells.~      So far, in vivo image systems are not able to visualize or identify the limbal stem cells~     directly. One alternative practical is to visualize the histological morphology of palisades~     of Vogt (POV), and to speculate the possible status of the stem cells accordingly. Slit-lamp~     biomicroscope can be used routinely for clinical examination of the limbal morphology.~     However, this technology does not allow for high resolution imaging of structural details~     and only up to 20% of patients can be identified. In vivo confocal microscopy has been used~     to visualize the POV and can provide cellular level resolution images, but the technique is~     limited by high magnification that restricts the area of the scan, and requires contact with~     the eye. Besides, both slit lamp biomicroscopy and in vivo confocal microscopy have the~     limitation of not being able to give an overall view of the dimension and structure of the~     whole palisades region.~      Anterior segment optical coherence tomography (AS-OCT) is a noninvasive, rapid and~     reproducible technique to evaluate the anterior segment and can also provide in vivo spatial~     information. The purpose of the study is to assess the role of aging and regions on the~     limbus.~   "
42544|NCT02500121|"~     This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial~     of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with~     metastatic urothelial cancer who have achieved at least stable disease on first-line~     chemotherapy.~   "
42545|NCT02500108|"~     The purpose of this study is to assess the risk of serious cardiac events, specifically~     ventricular tachyarrhythmia and sudden cardiac death (VT/SCD), associated with the use of~     domperidone in a population of patients with Parkinson's disease. The hypothesis for this~     study is that the risk of VT/SCD will be higher among domperidone users, especially at a~     higher dose.~      The investigators will conduct a retrospective population-based cohort study using health~     care databases in eight jurisdictions in Canada and the UK. The study cohort will be defined~     by the initiation of a new antiparkinsonian drug or a new diagnosis of Parkinson's disease.~     The results from the separate sites will be combined by meta-analysis to provide an overall~     assessment of the risk of VT/SCD in users of domperidone.~   "
42546|NCT02500095|"~     Background: Calorie restriction increases longevity in many species and attenuate the~     development of chronic disorders including type 2 diabetes, cardiovascular diseases and~     cancer. In mice reduced activity of insulin-like growth factor I (IGF-I) and/or insulin is~     associated with extended longevity. Growth hormone (GH) is the main regulator of IGF-I~     production, but the molecular mechanism whereby GH switches from IGF-I stimulation (protein~     anabolism) to fatty acid oxidation (fatty acid catabolism) as well as induction of insulin~     resistance during fasting remains enigmatic.~      Hypotheses: The changes of the global set of metabolites, induction of insulin resistance,~     and the shift in metabolism from protein anabolism to lipolysis together with the~     potentially favorable effect of calorie restriction during fasting depend on preserved~     fasting-induced GH secretion.~      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in~     signaling pathways that take place at the transition to the fasting state among healthy~     overweight and obese subjects. Furthermore the investigators wish to determine the effect of~     GH on the adaption of the metabolism to a fasting state.~   "
42547|NCT02500082|"~     The purpose of this study is to determine whether triheptanoin (UX007) is effective in the~     treatment of neurological symptoms related to citrate transporter deficiency (SLC13A5 gene~     mutation).~   "
42548|NCT02500069|"~     The appearance of intact macronutrients in the small intestine can result in the activation~     of an intestinal brake; a negative feedback mechanism from different parts of the intestine~     to the stomach, the small intestine and to the central nervous system. These processes~     inhibit food processing, appetite sensations and food intake, and furthermore they increase~     feelings of satiety and satiation. The researchers will investigate the effects of~     intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food~     intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and~     glucose and insulin.~   "
42549|NCT02500056|"~     The aim of the present study is to determine whether usage of mesh with larger pores,~     compared with mesh with smaller pores, would result in decreased rate of chronic pain after~     open inguinal hernia repair. The patients are randomized into two study gropus receiving~     mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1~     month, 6 months and 3 years after the operation.~   "
42550|NCT02500043|"~     The purpose of this trial is to compare the effects of TAS-102 and best supportive care~     (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.~   "
42575|NCT02499718|"~     Assessment of the effect and safety of noninvasive positive pressure ventilation for severe~     stable chronic obstructive pulmonary disease~   "
42552|NCT02500017|"~     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot~     clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms~     of Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin~     treatment on weight, metabolic parameters and sleep parameters in individuals with NES.~   "
42553|NCT02500004|"~     To study BAT activity and energy metabolism in patients with cachexia induced by cancer or~     chronic disease.~   "
42554|NCT02499991|"~     Research shows that there are a plenitude of interventions that can be used to enhance~     memory for older adults; however, the evidence as to whether these interventions enhance~     memory for daily activities is equivocal. The purpose of this pilot study is to test a~     memory intervention that is potentially useful in everyday life. Objectives of the pilot~     study are: 1) to examine the feasibility of the intervention (e.g., ease of use of materials~     provided); and 2) to gain preliminary evidence of the intervention's impact on recall of~     recent daily social events. Participants will be 20 cognitively healthy (i.e. not~     cognitively impaired) older adults, with 10 participants randomly assigned to either an~     intervention or control group, respectively. The study will consist of: a) a pre-training~     session; b) seven days of independent memory training; and c) a post-training session. The~     pre-training session will involve a test that measures recall of daily social events from~     the previous week. This will be followed by seven days of training for recall of daily~     social events. During the seven days, the intervention group will perform daily memory tasks~     using self-instructional materials given to them by the researcher, whereas the control~     group will use their own strategies for remembering social events that they are involved in~     during the week. The post-training session will occur after the seven days and will involve~     the same test as the pre-training session that measures recall of social events from the~     previous week. The hypotheses are that: a) recall of social events will be higher for the~     post-training test than in the pre-training test and; b) recall will be better for in the~     intervention group than the control group. The ease of use of the memory recall materials~     provided to the intervention group will be assessed in interviews.~   "
42555|NCT02499978|"~     This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™,~     DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable~     HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy~     will be effective in maintaining virologic suppression at 48 weeks of treatment.~   "
42556|NCT02499965|"~     The purpose of this study is to determine whether or not the pain of IV catheter insertion~     in the Emergency Department can be reduced significantly with the use of a rapid acting~     topical anesthetic spray and to determine whether or not healthcare providers who undergo~     such treatment are likely to endorse its use in their future practice.~   "
42557|NCT02499952|"~     This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in~     patients with incurable platinum refractory germ cell tumors. No randomization or blinding~     is involved.~   "
42558|NCT02499939|"~     The primary purpose of the trial is to determine the preliminary efficacy of therapeutic~     ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced~     peripheral neuropathy.~   "
42559|NCT02499926|"~     Amino acids are the building blocks of the body's protein and are used to build muscle, body~     tissue, and to support the immune system. Amino acids play a crucial role in growth and~     development of our body, especially in young children. However, some rare genetic diseases~     do not allow for proper digestion of these amino acids and so protein needs to be restricted~     in the diet of people who live with these conditions. One such disorder of lysine (an amino~     acid) is called Pyridoxine Dependent Epilepsy(PDE) where lysine is restricted in the diet of~     children and adults who live with this condition. Although diet restrictions are common for~     such genetic disorders, some people find it hard to follow restrictions and so alternative~     treatment methods have been developed. One such alternative treatment methods is to provide~     an excess of a competitive amino acid, in this case, arginine to reduce or stop the~     digestion and/or absorption lysine. Our aim is to examine if arginine can reduce lysine~     digestion/absorption under conditions of normal lysine intake.~      Animal experiments have shown that the body's ability to absorb lysine from the diet and~     thereby accumulating in the brain can be altered by adding more of another competitive~     amino acid, in this case, arginine. This is because lysine and arginine share the same~     transport system in the body. In other words, the breakdown of lysine (lysine oxidation) can~     be altered by adding additional arginine to the diet. Such changes can be studied in human~     body with the use of stable isotopes. Stable isotope techniques may help us gain a better~     understanding of how arginine can affect lysine absorption in the body.~      Although, the arginine supplementation described above is primarily for PDE patients, the~     investigators propose to study this 13C- lysine tracer protocol in healthy adult men to~     generate pilot data.~   "
42560|NCT02499913|"~     Alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and~     this population is overrepresented by minorities and disproportionately affected by~     alcohol-related morbidity and mortality. Contingency management is a behavioral intervention~     effective in reducing substance use, but few studies have evaluated the efficacy of~     contingency management in the context of soup kitchens or homeless programs. The~     investigators found that contingency management, using a twice weekly testing and~     reinforcement schedule, had benefits for decreasing drinking in individuals receiving~     services at a homeless shelter. This study will replicate and extend these earlier findings~     to a soup kitchen population using more sophisticated alcohol monitoring procedures to~     better assess the extent of drinking in this group and in response to a contingency~     management intervention reinforcing submission of negative breath samples. Specifically, 40~     hazardous drinkers recruited from a soup kitchen will be randomly assigned to one of two~     conditions: alcohol monitoring or the same plus reinforcement for provision of daily~     negative breath alcohol samples. The interventions will be in effect for 3 weeks, and all~     participants will also wear transdermal continuous alcohol monitors during the intervention~     period. Objective and subjective indices of alcohol consumption will be evaluated and~     compared between and within the treatment conditions. This pilot project will provide~     information regarding the effect size of contingency management reinforcing negative breath~     samples in an important health disparities group, and results from this study will guide~     subsequent grant applications focusing on methods to decrease drinking in this underserved~     population.~   "
42561|NCT02499900|"~     The primary objective of this study is to compare patient medication satisfaction as~     measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40~     mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6~     months of treatment.~   "
42599|NCT02499406|"~     Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of~     Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion~     dysregulation.~   "
42562|NCT02499887|"~     The purpose of the proposed study is to determine whether the addition of inhaled~     corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat~     emergency department (ED) visits among patients treated for acute exacerbations of asthma~     and COPD discharged from the emergency department to home. The investigators hypothesize~     that patients treated with inhaled corticosteroids in addition to oral corticosteroids and~     albuterol will have lower rates of 30-day return visits to the emergency department than~     those patients treated with oral corticosteroids and albuterol only.~   "
42563|NCT02499874|"~     The purpose of the study is to measure the drug levels in your blood and to find out whether~     a reduced dose (400mg) of the anti-HIV medication Efavirenz is safe when taken during~     pregnancy.~      The study will recruit HIV infected women who take Efavirenz as part of their anti-hiv~     treatment and who are pregnant.~      Efavirenz has been shown to be safe in pregnancy and at the standard dose that everybody~     takes of 600mg once a day, it shows levels that are enough to treat HIV and give birth to a~     HIV negative baby.~      Efavirenz at a dose of 400mg once daily works against HIV too but this dose has not been~     given to HIV positive pregnant women.~      People with HIV may benefit from using a dose of efavirenz of 400mg instead of 600mg, as~     lower drug doses could have fewer side effects and be tolerated better.~      Dose reduction would also make the drug cheaper. This would allow more people to be treated~     and free up money for other important work in the fight against HIV such as education and~     prevention programs.~      However, it is not known whether 400mg of Efavirenz works as well as 600mg of Efavirenz~     during pregnancy and this is why the investigators are conducting this study, which aims to~     measure the amount of Efavirenz 400mg in HIV pregnant women's bodies when they are taking~     400mg of Efavirenz once a day.~   "
42564|NCT02499861|"~     This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the~     isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the~     maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory~     leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory~     leukemias will be included. To further evaluate the treatment efficacy and gain further~     insight into action of these drugs, the DNA methylation levels before and after treatment~     for all participants, pharmacokinetics parameters such as through level for decitabine and~     through and peak level for genistein will be measured. Pharmacogenomics testing for~     decitabine will be performed prior to cycle 1 of treatment.~      Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and~     genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest~     period.~   "
42565|NCT02499848|"~     To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically~     significant localised low to intermediate prostate cancer.~   "
42566|NCT02499835|"~     This randomized pilot trial studies vaccine therapy and pembrolizumab in treating patients~     with prostate cancer that does not respond to treatment with hormones (hormone-resistant)~     and has spread to other places in the body (metastatic). Vaccines made from deoxyribonucleic~     acid (DNA), such as pTVG-HP plasmid DNA vaccine, may help the body build an effective immune~     response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may find tumor~     cells and help kill them. Giving pTVG-HP plasmid DNA vaccine and pembrolizumab may kill more~     tumor cells.~   "
42567|NCT02499822|"~     The purpose of this study is~        1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in~          subjects with elevated blood pressure variability.~        2. to assess whether the degree of treatment-induced changes in blood pressure~          variability, is related to the degree of regression (or progression) of organ damage in~          heart, kidneys and carotid arteries.~   "
42568|NCT02499809|"~     High intensity exercise can lead to muscle damage, resulting in muscle soreness, swelling~     and reduction in muscle strength. If the recovery is not sufficient or efficient it can~     increase the risk for injury and decrease the ability of the athlete to perform repetitive~     exercise and maintain overall performance.~      There are a variety of recovery aids which are being used by athletes, such as: the use of~     compression garments, massage, cold water immersion, sauna etc. Additional recovery strategy~     currently growing in popularity is the application of vibration.~      The evidences regarding the benefits of vibration therapy as a recovery aid are limited,~     specifically in athlete. Therefore, the proposed study will examine the use of vibration~     therapy as a recovery tool. The efficacy of this technique will be measure using functional~     and field tests.~   "
42569|NCT02499796|"~     This study compares the short-term effects of a new humidification system (Hygrovent Gold)~     and two other humidification devices (heated and moisture exchanger and heated humidifier)~     on respiratory pattern and work of breathing, during invasive ventilation.~   "
42570|NCT02499783|"~     This study will evaluate the efficacy and safety of adalimumab induction and maintenance~     treatment in subjects with moderately to severely active Crohn's disease.~   "
42571|NCT02499770|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to carboplatin and etoposide in first line treatment for~     patients with newly diagnosed extensive-stage SCLC.~      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a~     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening~     Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day~     of first dose with study treatment and completes at the Post-Treatment Visit. Approximately,~     110 patients will be enrolled in the study.~   "
42572|NCT02499757|"~     The investigators' aim is to test the prediction that sweet taste perception enhances the~     ability of nicotine to induce neural plastic changes in brain reward circuits to increase~     the saliency, liking and brain reactivity to the sight and vaporized flavor of electronic~     cigarettes (e-cigarettes).~   "
42573|NCT02499744|"~     The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is~     effective and safe as primary respiratory support in neonate with respiratory distress~     syndrome(RDS). It is more convenient in HHFNC combined with kangaroo care.~   "
42574|NCT02499731|"~     Strong Hearts, Healthy Communities is a research study which aims to reduce cardiovascular~     disease (CVD), improve quality of life, and reduce CVD related health care costs in rural~     communities.~      The investigators' aim is to better understand how changes in lifestyle can affect the~     health of rural women and others in their communities.~   "
42576|NCT02499705|"~     The purpose of this study is to investigate the effects of dietary exposure to artificial~     sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI,~     psychophysical measures, and questionnaires. The investigators hypothesize that dietary~     exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift~     preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala~     to sweet taste compared to sucrose.~   "
42577|NCT02499692|"~     Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites~     across China, the primary endpoint is Technical success.~   "
42578|NCT02499679|"~     The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes~     and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic~     patients with coronary artery disease (CAD) in order to further inform patients, health care~     providers, and other stakeholders about which technologies are most effective and efficient~     in the diagnosis and management of CAD.~   "
42579|NCT02499666|"~     The purpose of this project is to objectively assess the change (improvement) in exercise~     capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic~     total occlusion (CTO)~   "
42580|NCT02499653|"~     This study aims to analyze the impact of a brief psychological support intervention in the~     promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic~     Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of~     this intervention on both physical and psychological well-being, and consequently, a~     reduction of health costs.~   "
42581|NCT02499640|"~     The aim of the present study was to investigate the effects of cold water immersion (CWI)~     during post-exercise recovery with different durations and temperatures on heart rate~     variability (HRV) indices. 100 participants performed a protocol of jumps and a Wingate~     test, and immediately afterwards were immersed in cold water, according to the~     characteristics of each group (CG: control; G1: 5' at 9±1°C; G2: 5' at 14±1°C; G3: 15' at~     9±1°C; G4: 15' at 14±1°C). Analyses were performed at baseline, during the recuperative~     technique (TRec) by CWI and 20, 30, 40, 50 and 60 minutes post-exercise. The HRV indices~     average of all RR intervals in each analysis period (Mean RR), standard deviation of normal~     R-R intervals (SDNN), square root of the mean of the sum of the squares of differences~     between adjacent R-R intervals (RMSSD), spectral components of very low frequency (VLF), low~     frequency (LF) and high frequency (HF), scatter of points perpendicular to the line of~     identity of the Poincaré Plot (SD1) and scatter points along the line of identity (SD2) were~     assessed. Comparisons between groups and moments were performed using the technique of~     analysis of variance for repeated measures in two scheme factors. A significance level of~     p<0.05 was considered.~   "
42582|NCT02499627|"~     This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating~     the efficacy and safety of the combination of bendamustine and brentuximab vedotin as a~     first salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL. A~     total of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated~     according to this treatment protocol. In the study, intravenous bendamustine will be~     administered at a dose of 90 mg/m2 on day 1 and 2 and brentuximab will be given~     intravenously at a total dose of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6~     cycles. All patients achieving a CR can be considered eligible to peripheral blood stem cell~     mobilization (to be performed with granulocytecolony stimulating factor alone) and may~     proceed to an ASCT at any time after cycle 4.~   "
42583|NCT02499614|"~     Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1~     translocation or MET amplification~   "
42584|NCT02499601|"~     The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12~     months of follow up, and to evaluate the performance of the therapy in relieving symptoms~     and restore diastolic function in patients with heart failure and preserved ejection~     fraction.~   "
42585|NCT02499588|"~     The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin~     over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as~     part of their standard protocol of care following surgery.~   "
42586|NCT02499575|"~     Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In~     this study the investigators plan to determine the ability of Exparel to control~     post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion~     surgery, 1st MTP fusion, and cheilectomy).~   "
42587|NCT02499562|"~     To explore the effective dose and safety of the effect of hydronidone and entecavir on~     hepatic fibrosis in chronic viral hepatitis B.~   "
42588|NCT02499549|"~     To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the~     eradication of head lice. To assess the ability of each treatment regimen to kill all viable~     ova and to assess patient acceptability of the product in use~   "
42589|NCT02499536|"~     The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding~     on intraoperative lung ultrasound.~   "
42590|NCT02499523|"~     A prospective, interventional, monocentric, controlled and randomized study will compare a~     conventional surgical technique to a surgical technique with the assistance of the~     Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement~     (THR).~   "
42591|NCT02499510|"~     The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent~     designed to have superior radial strength, flexibility and durability compared to standard~     nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the~     safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of~     peripheral vascular disease in the femoropopliteal arteries.~   "
42592|NCT02499497|"~     This research study is studying the use of a targeted therapy called LY SARM, which is an~     investigational drug from a new class of molecules called Selective Androgen Receptor~     Modulators (SARMs) as a possible improvement in quality of life for participants who have~     undergone radical prostatectomy. Androgens are a group of hormones that play a role in male~     traits and reproductive activity.~      The names of the study interventions involved in this study are:~      - LY2452473~   "
43845|NCT02483104|"~     This is a Phase 1, open-label, multicenter, dose escalation study evaluating the~     tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination~     with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.~   "
42593|NCT02499484|"~     The primary objective of this research is to determine if the addition of topical GTN over~     24 weeks to a 12 week exercise programme improves clinical outcomes more than placebo GTN~     for people with Achilles Tendinopathy.~      Pain in the Achilles tendon is a common condition seen by physiotherapists and doctors. It~     affects people involved in sports and those who are not. It can limit the ability to walk,~     hop, jump and run. If the pain persists for longer than 3 months it can become extremely~     difficult to abolish. As a result, people with this common condition can suffer from~     prolonged pain and often the pain will persist and affect everyday activities.~      While this is an easy injury to diagnose, it is not so easy to treat. Many treatments do~     exist, but often just provide short-term relief until the pain returns. Specific~     strengthening exercises have been shown to be beneficial in treating this condition.~      The current project will study Achilles tendon pain in Irish adults at Connolly Hospital,~     Dublin, and will take place from 2015 to 2019. In this study, there are two groups of~     patients. Both groups will perform an exercise program for 12 weeks. Physiotherapists will~     instruct them on how to perform the exercises. Each group will be given an ointment to place~     on the sore tendon using an applirule. This ointment will be applied daily for 6 months. One~     group will use an ointment containing nitroglycerin, the other group will use an ointment~     with no active ingredient. This is called a placebo. The patients will apply the ointment~     daily for 6 months.~      The patients will be assessed at the start of the program and after 6, 12 and 24 weeks. Our~     main question is to see whether this exercise program when combined with a nitroglycerin~     ointment applied directly over the sore tendon can improve the outcomes and recovery time~     for people who suffer with Achilles tendon pain.~   "
42594|NCT02499471|"~     Rationale: During the last decades, research in possible therapies for existing obesity and~     developmental factors causing obesity has explosively increased. Recently renewed interest~     aroused for a tissue playing a possible role in both development and therapy for obesity:~     brown adipose tissue (BAT).~      To define the relation between BAT and thyroid hormone, the investigators set up the~     following research protocol. In this protocol BAT activity will be determined in subjects~     that underwent thyroidectomy for well-differentiated thyroid carcinoma.~      Objective: To study the effect of thyroid hormone and thyroid-stimulating hormone on brown~     adipose tissue activity.~      Study design: Determine BAT activity after thyroidectomy in well-differentiated thyroid~     carcinoma patients.~      Study population: Patients that underwent thyroidectomy for well-differentiated thyroid~     carcinoma, male and female, aged 18-65 years.~      Intervention: FDG-PET-CT-imaging ([18F]fluorodeoxyglucose positron-emission-tomography~     computed-tomography) of BAT activity will be performed under cold stimulation twice.~      For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will~     be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement~     will take place in a euthyroid state 4 months after the start of thyroid hormone treatment.~      For patients receiving recombinant-thyroid-stimulating-hormone injections, the first~     occasion will be shortly after the injection in a state of high thyroid-stimulating hormone~     levels. The second measurement will be in a euthyroid state 4 months after the injection.~      Main study parameters/endpoints: The main endpoint of this study is the effect of thyroid~     hormone and thyroid-stimulating hormone on BAT activity in kBq (kilobecquerel) and SUV~     (standard uptake value). Secondary endpoints are the effects of thyroid hormone and~     thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface~     temperatures and skin perfusion.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The absorbed radiation dose from the FDG PET-CT scan after administration of 74~     MBq (megabecquerel) of 18F-FDG is 2.8 mSv (miliSievert).~   "
42595|NCT02499458|"~     Circulating tumor cells (CTCs) have prognostic value in several tumor types, and increasing~     evidence suggests that molecular characterization of CTCs can serve as a liquid biopsy to~     understand and address treatment resistance. The goal of this proposal is to demonstrate~     that CTCs can be accurately enumerated and characterized in metastatic clear cell renal~     cancer (CCRC) and can serve as prognostic/predictive biomarkers to improve treatment. The~     challenge surrounding CTC analysis in CCRC is that most CTC technologies (including the~     clinical gold-standard CellSearch®) depend in epithelial markers such as EpCAM that are~     expressed at low or heterogeneous levels in CCRC. Members of the research team have~     developed a novel CTC microfluidic technology that can effectively detect CTCs that are~     completely undetectable by CellSearch® because of very low EpCAM expression, as well as~     allowing for CTC recovery for downstream molecular characterization. The goal of this~     proposal is therefore to test the hypotheses that (1) The microfluidics CTC technology will~     have better sensitivity/specificity relative to the CellSearch in metastatic CCRC; and (2)~     Enumeration of CTCs in metastatic CCRC patients (n=66) will have prognostic value, while~     molecular characterization of CTCs for expression of biomarkers (VHL, VEGF, mTOR, HIF1/HIF2,~     AKT) related to CCRC etiology will be predictive of response/resistance to targeted~     therapies. Although CCRC is relatively uncommon, the lack of established adjuvant treatments~     and high cost of targeted therapies in the palliative setting makes the search for new~     prognostic/predictive biomarkers an important clinical goal.~   "
42596|NCT02499445|"~     In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different~     anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site~     concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane~     (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI~     effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of~     Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control),~     during vascular graft harvesting (harvesting), after completing graft construction~     (postgrafting), and one day after surgery (postoperative).~   "
42597|NCT02499432|"~     To further increase the access of evidence based psychotherapies for Veterans with~     Posttraumatic Stress Disorder, we propose to offer training and intensive consultation to~     community-based providers in Cognitive Processing Therapy for Posttraumatic Stress Disorder.~     However, we believe that many clinicians may not implement Cognitive Processing Therapy or~     take advantage of consultation after initial training. For this reason, we propose to~     examine the effectiveness of an enhanced training method, which would add Motivational~     Interviewing to the standard Cognitive Processing Therapy training. Motivational~     Interviewing is a form of collaborative discussion for strengthening motivation and~     commitment to change. We hypothesize that augmenting the standard Cognitive Processing~     Therapy training with these techniques will reduce providers' reluctance to fully implement~     the interventions.~   "
42598|NCT02499419|"~     Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of~     the leaflets of the mitral valve prolapse during systole into the left atrium.~      The disease is very heterogeneous and can vary from a benign disease with almost no impact~     on the patient's life to a severe cardiac problem with many complications and high mortality~     rate.~      The purpose of the study is to see if the investigators can find a relation between the~     severity of the MVP to the exercise capacity of the patient. The investigators also want to~     see if they can find a difference between the exercise capacity of mild MVP patients and~     healthy people.~      To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary~     Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the~     subject's functions during exercise. By combining gas exchange monitoring and ECG during a~     controlled exercise in which the subject reaches maximal effort, the test gives information~     about the cardiac, the pulmonary and the metabolic functions of the subject. This~     information can help identify if there is a problem to perform exercise properly and more~     specifically if the limitation is due to a cardiac, pulmonary or metabolic problem.~   "
42600|NCT02499393|"~     New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH)~     should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult~     and present with signs of moderate and/or severe hypoxic - ischemic encephalopathy (HIE) .~     Despite the evidence from several randomized control trial (RCT) proving its effectiveness,~     its effect is perceived insufficient or only modest. Thus today's research efforts are~     directed toward finding the new possibilities of enhancing the effects of hypothermia. List~     of agents with potential neuroprotective properties includes: erythropoetin, melatonin,~     topiramate, morphine, xenon, MgSO4. Given investigators previous experiences with preterm~     neonates exposed to MgSO4 prenatally or administered this drug after birth because of~     perinatal asphyxia, the investigators designed the trial which would evaluate the~     possibility of increasing the TH effect by combining this method with MgSO4. Until now there~     are several published studies evaluating the effectiveness of MgSO4 in the group of~     asphyxiated neonates, including one RCT. However, all of these studies were conducted before~     the era of TH Furthermore, irrespective of the potential benefits, safety of using MgSO4~     during TH in the group of term neonates was not studied. It is particularly important in the~     light of the results presented by Mittendorf et.al. They studied the effects of prenatal~     aggressive treatment with MgSO4 on the outcome of preterm neonates showed that patients~     exposed to high doses of MgSO4 were at higher risk of severe intracranial bleeding. Other~     side effects of high serum magnesium levels are: vasodilatation, hypotension, cardiac~     arrhythmias, coagulopathy, and gastrointestinal disturbances. MgSO4 is a very attractive~     neuroprotective option,also because of its easy availability. Drug can be administered in~     the birth hospital while neonate is being prepared for the transport to TH center. Timing of~     the intervention is very important for neonates suffering from perinatal asphyxia. Both TH~     and administration of potentially neuroprotective drug should be started during therapeutic~     window. It is the initial potentially reversible phase of hypoxic insult lasting about 6~     hours. If the long-term follow up shows that MgSO4 has an additive neuroprotective effect~     and no significant side effects in the group of asphyxiated neonates treated with TH this~     relatively simple and not expensive intervention may be introduced into clinical practice~   "
42601|NCT02499380|"~     The objective of this post-marketing study is to advance the understanding of the mechanism~     of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac~     performance in patients with emphysema treated with the RePneu Coils, when used as intended.~   "
42602|NCT02499367|"~     This is a single center non-blinded randomized non-comparative phase II trial. The first~     stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1~     with no induction treatment before nivolumab).~      For the second stage, the number of arms will be reduced based on the results obtained in~     the first stage.~   "
42603|NCT02499354|"~     The purpose of the study is to determine the relative effect size of standard IV and oral~     iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of~     treatment response.~   "
42604|NCT02499341|"~     The purpose of the study is the comparison between ketamine and tramadol, regarding the~     analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA)~     morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies,~     Whipple procedures and peripheral pancreatectomies. The goal is to bring out an improved~     analgesia scheme, which can be applied to the clinical work and refine the analgesia~     provided for major procedures which require increased postoperative opioids doses. In the~     study, half of patients will receive continuous intravenous infusion of tramadol and Patient~     Controlled Analgesia morphine and the other half will receive continuous intravenous~     infusion of ketamine and Patient Controlled Analgesia morphine postoperatively after major~     upper abdominal surgery. The successful combination of different drugs targets at the~     improvement of the analgesia provided, the reduction of complications and the exploitation~     of the pharmacodynamic properties of each drug.~   "
42605|NCT02499328|"~     This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a~     dose-escalation, safety run-in Part A and a dose-expansion Part B~   "
42606|NCT02499315|"~     The purpose of the study is to find out if AMG 357 is safe and tolerated by women with~     Rhematoid Arthritis.~   "
42607|NCT02499302|"~     The general aim of this study is to investigate the effect of an individually tailored~     mental training program in adolescents developing chronic fatigue syndrome (CFS) after an~     acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary~     endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and~     markers of disease mechanisms (autonomic, endocrine, and immune responses).~   "
42608|NCT02499289|"~     Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising~     reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy~     complications), metabolic [insulin resistance (IR), increased type 2 diabetes mellitus~     (T2DM) and cardiovascular disease (CVD) risk factors] and psychological features (worsened~     quality of life and increased anxiety and depression) Whether prolonged fasting during~     Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and subsequently~     improve the ovulation and spontaneous pregnancy will happen without ovarian stimulation.~   "
42609|NCT02499276|"~     Experimental animal data suggest that increasing breathing pattern variability in mechanical~     ventilation could be beneficial. Variable ventilation can be induced through the following~     modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and~     Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to~     each other. Pilot observations in our department suggest a feasibility in patients.~      The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the~     variability of the breathing pattern, patient-ventilator asynchrony, risk of lung~     overdistension, gas exchange, and repartition of ventilation.~   "
42610|NCT02499263|"~     This is a prospective, single country, multi-center study in Ulcerative Colitis (UC)~     patients treated with adalimumab. 200 subjects will be enrolled at approximately 20 sites.~     The baseline assessment should be performed prior to the first dose of adalimumab (Visit1).~     Study visits will be conducted at weeks 8, 16, 24, 32, 40, 48 and 56 in accordance with~     clinical practice. All subjects will have one Follow-up for safety approximately 70 days~     after the last dose of adalimumab~   "
42611|NCT02499250|"~     The purpose is to test whether daily ischemic conditioning of the arms over 30 days could~     reduce the frequency and severity of angina pectoris and improve the life quality of~     refractory angina pectoris patients.~   "
42612|NCT02499237|"~     In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of~     bone mineral density gains. The investigators aim to evaluate whether in patients treated~     with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.~   "
42613|NCT02499224|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid~     tumors patients who are refractory to standard therapy.~   "
42614|NCT02499211|"~     Using a cluster randomized controlled design, this study will evaluate effects of in-store~     healthy food marketing strategies on sales and purchase of specific healthier items in six~     product categories (milk, frozen entrees, beverage checkout coolers, salty snacks, bread and~     cheese); and examine the effects of changes in in-store food marketing environments on sales~     of healthier foods. If these strategies are found to be effective, they could be used widely~     to encourage healthy retail sales, complement food access initiatives, and reduce health~     disparities in obesity and other diseases. Supermarkets will be the unit of randomization,~     intervention, and analysis.~   "
42615|NCT02499198|"~     Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to~     the potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its~     endogenous synthesis from nornicotine. The proposed study will lead to an understanding of~     the endogenous formation of NNN from nornicotine in humans, and will also investigate the~     effect of the reduction of nornicotine content in smokeless tobacco on the extent of~     endogenous NNN formation. The knowledge gained in this study will lead to the development of~     recommendations for the regulation, or potentially elimination, of nornicotine in smokeless~     tobacco products in order to minimize exposure to NNN in the users of these products.~   "
42616|NCT02499185|"~     To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra~     abdominal surgery.~   "
42617|NCT02499172|"~     This study, to be carried out immediately following an emergency, reactive cholera~     vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the~     safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on~     pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine~     is safe in pregnant women, this setting will allow investigators to answer this question in~     a community where more than 100,000 people will receive vaccine with no restrictions on~     pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant~     women were excluded due to lack of safety data. However, in this campaign, the decision by~     the Ministry of Health is that the benefits of offering vaccine to all individuals~     regardless of pregnancy status far outweigh any theoretical risk. Here the investigators~     specifically propose to:~      Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy~     outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in~     a reactive vaccination campaign that started on 30 March 2015. Through household surveying~     and enrollment of pregnant women with monthly follow-up visits, the investigators will~     determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and~     unvaccinated women in Nsanje and Chikwawa Districts, Malawi.~      Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and~     stillbirth) of women who received oral cholera vaccine while they were pregnant to women who~     were vaccinated and became pregnant after the end of the final round of vaccination in~     Nsanje and Chikwawa Districts, Malawi.~      Specific Objective 3: To compare the incidence of newborn malformations in a cohort of~     infants that had fetal exposure to oral cholera vaccine compared to those without such~     exposure in Nsanje and Chikwawa Districts, Malawi.~   "
42618|NCT02499159|"~     This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on~     decreasing the amount of consumed pain medications.~      Patients will be randomly selected to received either Exparel or standard bupivicaine~     injection during surgery. Patients will be followed up to assess pain levels using a visual~     pain scale, and to assess how much pain medication was consumed.~   "
42619|NCT02499146|"~     As part of the global clinical development program for Palbociclib, studies are planned in~     cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients,~     as required by the Chinese Health Authorities, is therefore warranted. In addition, safety~     and efficacy will be also evaluated.~      The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be~     characterized.~   "
42620|NCT02499133|"~     Researches that focus on the perception of prosodic elements among adult who suffered~     traumatic brain injury (TBI), focus on their ability to decipher intonation in order to~     understand an additional meaning of a sentence. According to these researches, adults who~     suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering~     intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to~     broaden the knowledge in this domain by examining the ability of adults with TBI to~     understand an additional prosodic element - focused stress.~      The ability to identify and understand focused stress in a sentence requires different~     abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an~     ability to understand the lexical grammatical meaning of the word as it negates other~     possible meanings (for example, in the sentence I'm eating a red apple the stressed word~     negated the option of a different color). Third, an understanding of the stressed word as it~     creates a different pragmatic/social meaning (for example, in the sentence mom, I asked for~     red, yellow and green candy the role of the stressed word is to mark the candy that the~     addressee didn't get).~      The aim of the study is to assess the ability of adults who had experienced TBI to grasp and~     understand the meaning of focused stress in the different contexts that were described~     above. An additional aim is to examine if differences in speech and cognitive abilities can~     describe some of the variation in the results.~      Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults~     who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy~     adults. Each participant with TBI will be matched to a healthy adult by gender, age,~     education and social-economic status. All of the participants will be Hebrew native~     speakers, with no learning disability, no neurological injury, proper speech abilities and~     no hearing impairment.~      The participants will undergo seven different tests in three different meetings (60 minute~     each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include~     different cognitive and language examinations. The main test of the study will be The Hebrew~     Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires~     identification of the stressed word in a sentence based on psychoacoustic abilities alone.~     The second and the third subtests require understanding the meaning of focused stress in~     different contexts - lexical grammatical and pragmatic/social. The test includes forty eight~     recorded sentences. In each sentence one word is stressed. The participants will be asked to~     listen to the recordings and answer a closed question regarding the stressed word.~   "
42621|NCT02499120|"~     The purpose of this study is to determine whether the combination of palbociclib with~     cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative,~     cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and~     neck.~   "
42622|NCT02499107|"~     This study will compare the effects of commonly consumed carbohydrate sources such as~     potatoes, pasta and rice along with a fixed portion of meat on blood glucose, satiety and~     insulin levels among healthy body weight children. Healthy boys and girls, aged between 11 -~     13 years old, will be involved in this study.~   "
42623|NCT02499094|"~     The purpose of this study is to validate the effectiveness of using an integrated mobile~     sensing platform to deliver large-scale data-driven interventions to patients with~     depression.~   "
42624|NCT02499081|"~     The purpose of this study is to evaluate the effect of Ixazomib on inducing osteoblast~     activation as measured by bone markers and imaging in patients with relapsed/refractory~     myeloma.~   "
42625|NCT02499068|"~     The purpose of the study is to verify the clinical effectiveness of a managed home~     telemonitoring program in patients with severe COPD against usual clinical practice, as~     measured by the decrease in the number of exacerbations, number of hospitalizations,~     hospital days and emergency room visits in a 12 month period~      The primary endpoint of effectiveness is severe exacerbations avoided.~      The main hypothesis is that patients with severe or very severe COPD patients managed with a~     home telehealth program have better outcomes than patients managed according to usual~     clinical practice.~   "
43207|NCT02491450|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt)~     versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human Volunteers Under~     Fasting Condition.~   "
42626|NCT02499055|"~     Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care~     services plan to implement internet based self-help psychotherapy (IBT) to be an important~     alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the~     effect of IBT for anxiety disorders seems better than no intervention, and in some instances~     equal to 'usual therapy'. But studies have been characterised by small sample sizes, high~     risk for bias, including high dropout.~      Objective. The objective of this pilot trial is to assess the feasibility of conducting a~     larger confirmatory trial investigating the benefits and harms of an internet-based~     self-help therapy program, FearFighter™, compared with no intervention for persons with an~     anxiety disorder.~      Design. An investigator-initiated feasibility randomised clinical trial investigating~     internet-based therapy with FearFighter™ compared with no intervention for persons with an~     anxiety disorder. We will include 64 participants.~      Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder,~     agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed~     consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or~     psychosis; concurrent psychological treatment for the anxiety disorder; unable to attend the~     intervention; or lack of informed consent.~      Intervention. The intervention group will use the program FearFighter™, a nine session~     cognitive behavioural self-help therapy program delivered over the internet during nine~     weeks. The control group receive no intervention for nine weeks.~      Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are~     randomised, and the compliance in the intervention group. Clinical exploratory outcomes are:~     remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan~     Disability Scale, serious adverse events, and behaviour log from FearFighter.~      Time schedule. Participants will be included in the trial from July 2015. Results are~     expected in February 2016.~   "
42627|NCT02499042|"~     This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen~     delivery in adult patients who have been resuscitated from OHCA.~   "
42628|NCT02499029|"~     Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in~     veterans with PTSD and comorbid substance use disorders.~   "
42629|NCT02499016|"~     Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain~     additional benefits such as a better cosmetic outcome, the investigators developed a~     surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which~     creates a non-visible scar, that was preliminarily shown to be feasible and safe in our~     previous retrospective studies To further evaluate the feasibility, safety and cosmetic~     results of this innovative approach, the investigators compared the outcomes of SSILA and~     CLA by performing a randomized controlled trial.~   "
42630|NCT02499003|"~     The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101)~     in combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70~     patients with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed~     indolent lymphoma will receive up to 6 cycles of the described combination regimen. Follow~     up visits are scheduled for up to 3 years.~   "
42631|NCT02498990|"~     The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by~     continuous lifestyle advice is an effective option to achieve an improvement in glucose~     control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese~     type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is~     to investigate whether the weight reduction therapy also has significant impact on various~     anthropometric, clinical and metabolic parameters associated with obesity.~   "
42632|NCT02498977|"~     LIFT is prospective randomised marker-based trial to assess the clinical utility and safety~     of biomarker-guided immunosuppression withdrawal in liver transplantation. 'LIFT' aims to~     validate a biomarker test of operational tolerance to stratify liver transplant recipients~     before withdrawing immunosuppressive medication. Primary objective is clinical utility and~     risk/benefit ratio of employing a transcriptional test of tolerance to stratify liver~     recipients prior to immunosuppression withdrawal. Secondary objectives are: safety of~     biomarker-guided immunosuppression withdrawal; health-economic and quality of life impact of~     biomarker-guided immunosuppression withdrawal; improvement in drug-related co-morbidities;~     prevalence of tolerance over time; role of donor-specific anti-human leukocyte antigen (HLA)~     antibodies; identify mechanisms of liver allograft tolerance. It is a prospective,~     multi-centre, phase IV, biomarker-strategy design trial with a randomized control group in~     which adult liver transplant recipients will undergo immunosuppression withdrawal. The~     sample size is 148 patients.~   "
42633|NCT02498964|"~     High fidelity simulations provide a unique opportunity for teaching and evaluation of~     knowledge, clinical reasoning, decision making and teamwork. We have developed a series of~     novel cardiac based simulations that review difficult learning objectives of cardiac~     anesthesiology rotation. We hypothesized that residents who have completed a rotation in~     cardiac anesthesiology will perceive these simulations to be both mentally challenging and a~     useful tool in preparing them for their subsequent clinical experience and for their~     anesthesiology board. For the first time, we have used the NASA Task Load Index Scale in~     evaluating Neuro Cognitive Workload during Cardiac Anesthesia Based simulation scenarios~     .Residents who have completed the cardiac rotation at least once would be assigned the task~     in small groups either a group of 2 or group of 3.The module consists of 3 different~     scenarios. The scenarios include, weaning the patient off of cardio pulmonary bypass,~     management of severe protamine drug reaction and acute hypotension from malfunction of the~     coronary graft in a simulated operating room in real time.~        1. Setting up a Simulation Lab,almost similar to real cardiac operating rooms would have~          cardio-pulmonary bypass machine,trsnesophageal echocardiography images upon request,all~          emergency medications with various infusions pumps,defibrillator,real time monitors~          include EKG,SpO2,invasive arterial line,CVP,PAP,ETCO2,operating room surgical~          equipment,anesthesia machine with ventilator.~        2. Tasks Assigned to the residents~        3. Feed-back and Teaching Session~        4. At the end of each session residents are encouraged to reflect upon how they performed~          and learning gaps that they perceived and areas that they felt needed to improve upon.~        5. Feedback session would be followed by interactive teaching to reinforce the knowledge.~        6. Evaluation of Hypothesis using NASA TLX Scale. Immediately following the Simulation~          based training, residents would be given the paper based NASA TLX scale to assess the~          neurocognitive workload~   "
42634|NCT02498951|"~     This randomized phase II trial studies how well obinutuzumab works as maintenance treatment~     in patients with central nervous system lymphoma who have achieved the disappearance of all~     signs of cancer in response to treatment (complete response). Monoclonal antibodies, such as~     obinutuzumab, may kill cancer cells that are left after chemotherapy.~   "
42635|NCT02498938|"~     Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases.~     The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with~     COPD serve as a risk factor for developing periodontitis.~   "
42656|NCT02498665|"~     This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion~     administered to adult patients with advanced malignancies. Patients will be administered~     escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance~     with the following regimen: once weekly for four weeks during the Induction Phase, once~     every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days~     until a discontinuation criterion is met during the Maintenance Phase.~   "
42636|NCT02498925|"~     The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e.,~     1-3%), but increases substantially during adolescence. By the age of 18, approximately 15%~     of adolescents will have experienced at least one episode of MDD. A growing body of research~     implicates abnormalities in reward circuitry as playing a critical role in the development~     and maintenance of depressive symptoms in adolescents. Importantly, these reward-circuitry~     abnormalities have been linked to anhedonia (i.e., decreased pleasure or blunted reactivity~     to rewarding stimuli). Behavioral Activation (BA) represents a promising - and relatively~     simple to deliver - nonpharmacologic intervention for adolescent depression, which has been~     shown to be at least as effective as Cognitive Behavioral Therapy (CBT) with regards to~     symptom reduction and lowering the risk of relapse in adult samples. More recently,~     promising data have emerged from the application of BA to depressed adolescents. BA can be~     conceptualized as a treatment directly targeting anhedonia. More specifically, BA targets~     anhedonia through behavioral change strategies aimed at gradually increasing patients'~     exposure to and engagement with rewarding stimuli and positively reinforcing experiences.~     Given this treatment focus, BA may be particularly beneficial for adolescents struggling~     with relatively elevated levels of anhedonic symptoms. Accordingly, the present study will~     examine the role of anhedonia and reward functioning in predicting treatment response in BA.~     In addition, analyses will be conducted examining the reward-related neural and behavioral~     mechanisms underlying anhedonic symptom improvement in BA.~   "
42637|NCT02498912|"~     The purpose of this phase I study is to test the safety of different dose levels of~     specially prepared cells collected called modified T cells. In the screening part of this~     study the tumor was found to have a protein called MUC16. This protein is present on about~     70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for~     patients with this type of cancer that has progressed after standard chemotherapy. We also~     want to find out what effects these modified T cells have on the patient and their cancer.~   "
42638|NCT02498899|"~     The goal of this research study is to learn how patients view their doctor's compassion~     about supportive care and treatment options for advanced cancer patients.~   "
42639|NCT02498886|"~     At MRC Human Nutrition Research, the investigators have developed an engineered analogue of~     the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate~     tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an~     adipate buffer, with similar functional properties and small primary particle size (~2 nm)~     as the iron found in the ferritin core; it better mimics iron absorption from food than the~     non-physiological bolus doses of ferrous sulphate currently used.~      This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to~     ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation.~     The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised,~     single-dose study.~      Primary endpoint:~      Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from~     the red blood cell incorporation of isotope-labelled iron 14 days following a single oral~     dose.~      Secondary endpoints:~      Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin~     saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.~      Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum~     collected from each subject at 0, 2, 4 and 6 hours following a single dose.~   "
42640|NCT02498873|"~     In a competitive scenario, trainers and coaches seek to improve the performance of their~     athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks)~     training aimed at a specific moment of a competition. The organization variables, mainly the~     intensity of exercise in a training routine can stimulate important physiological pathways~     and uphold superior gains to VO2max, leading to a peak aerobic performance. However, due to~     lack of evidence, and the difficulty of control on a large scale, the effects of the~     intensity organization over a mesocycle periodization are still poorly investigated.~   "
42641|NCT02498860|"~     Two-Year Disease Free Survival Rate of Stage IB~IIIA adenocarcinoma after Adjuvant~     Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be~     recruited for 12 months, and followed for two years, thus the duration of study will be 36~     months.~   "
42642|NCT02498847|"~     Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and~     disability. Non-pharmacological interventions are recommended but are underutilized.~     Exercise reduces pain and improves physical function, but benefits tend to wane without a~     component to facilitate behavior change. Cognitive behavioral therapy (CBT) has long term~     benefits on pain and physical function in individuals with OA, but is not typically offered~     in clinical care. CBT could be taught in the context of clinical care by occupational~     therapists (OT). OTs help people manage chronic conditions by teaching behavioral strategies~     that promote health and function. The purpose of this study is to test the feasibility and~     efficacy of an OT-delivered cognitive behavioral therapy program to help people manage their~     knee OA.~   "
42643|NCT02498834|"~     The purpose of this study is to conduct a randomized controlled trial with English and~     Spanish-speaking adolescents to compare the effectiveness of an adolescent asthma question~     prompt list with a supportive educational video intervention with usual care.~      The hypothesis of this study is that by showing the parents and adolescents the educational~     video and then providing the adolescents with the one-page asthma question prompt lists to~     use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in~     managing asthma, and (c) adolescent quality-of-life.~   "
42644|NCT02498821|"~     The purpose of the study is to evaluate differences in the time and costs between Sherlock~     3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter~     (PICC).~   "
42657|NCT02498652|"~     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic~     (PD) effects of RDEA3170 administered in combination with allopurinol compared with~     allopurinol administered alone in adult subjects with gout.~   "
42658|NCT02498639|"~     Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy~     and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid~     ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary~     pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done~     through a dedicated computer program.~   "
42645|NCT02498808|"~     Neutrophils emerge as key immune cells in the initiation and perpetuation of immune~     responses in autoimmune diseases. They display marked abnormalities in phenotype and~     function in various autoimmune diseases, including systemic vasculitis, systemic lupus~     erythematosus (SLE) and rheumatoid arthritis (RA).~      These neutrophils are characterised by an extended life span, increased capacity to produce~     reactive oxygen species, active gene expression and release of extracellular traps.~     Consequently, there is a need for better understanding of neutrophil phenotype and functions~     in these conditions, as well as for identifying molecules capable of specifically~     manipulating neutrophil function. The investigators have recently discovered that interferon~     lambdas (IFN-λs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II~     cytokines with previously studied anti-viral biological functions, specifically suppress~     neutrophil infiltration and interleukin-1β production and thereby, halt and reverse the~     development of collagen induced arthritis (CIA). The investigators propose to further~     investigate the cellular and molecular mechanisms behind this suppression and examine the~     translational potential of the investigators' finding by examining the IFN-λ receptor~     expression and function in neutrophils isolated from the blood of healthy donors and~     rheumatic patients (early rheumatoid arthritis and vasculitis).~   "
42646|NCT02498795|"~     The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional~     form to the accomplishment of eccentric exercise's program in patients with chronic patellar~     tendinopathy is more effective than the accomplishment of an additional treatment with dry~     needling or eccentric exercise's program realized of isolated form.~   "
42647|NCT02498782|"~     The hypothesis is to evaluate if the treatment with Fexinidazole will lead to a better~     sustained clearance of the parasites at 6 months of follow-up when in comparison to placebo~     in patients with chronic indeterminate CD.~   "
42648|NCT02498769|"~     In this study, the investigators aim to determine whether injecting botulinum toxin into~     epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation~     (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum~     toxin injected into the epicardial fat pads reduces POAF and length of stay (LOS) without~     increasing adverse events. This will be a prospective randomized trial of 130 patients~     undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with~     cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50~     units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into~     epicardial fat pads. All patients will receive standardized anesthetic, surgical, and~     post-surgical care. The primary outcome in this study will be time to occurrence of~     in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction~     (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat~     pads, the investigators anticipate a significant reduction in the risk for POAF with~     epicardial botulinum in this cohort, which includes valve surgery patients.~   "
42649|NCT02498756|"~     For investigators' current experimental clinical trial, patients are given 4 injections of~     ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer~     therapy. Investigators propose to test this dual therapy in patients with melanoma who have~     known stage I, metastatic melanoma. Investigators hypothesize that this form of~     combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant~     prolongation of progression-free, disease-free or overall survival compared to the use of~     ipilimumab alone~   "
42650|NCT02498743|"~     The objective of this study is analyze the influence of TV entertainment in children less~     than 3 years of age during echocardiography in order to achieve a complete and accurate~     test.~      This is an experimental study in children with suspected congenital or acquired cardiac~     disease. An examination room was prepared with a TV on the ceiling that was positioned in a~     way that would provide unobstructed viewing for children during the echocardiography~     procedure.~   "
42651|NCT02498730|"~     Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity~     interval training compared to moderate intensity (same total work) on reducing the symptoms~     of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the~     investigators will establish what influence of gain to VO2max has on reducing symptoms.~   "
42652|NCT02498717|"~     This study will examine the initial efficacy and cost-effectiveness of using the~     cryocompression therapy model both pre-operatively and post-operatively in patients that~     have recently suffered a traumatic calcaneus or ankle fracture compared to the standard~     pre-operative RICE therapy procedures.~   "
42653|NCT02498704|"~     The purposes of this double-blinded, randomized controlled trial are (1) to determine if the~     addition of trigger point dry needling (TDN) to a standard stretching program results in~     greater improvements in hamstring flexibility versus stretching alone in a population with~     atraumatic knee pain; (2) measure length of time that flexibility gains are maintained, (3)~     assess resulting movement mechanics and (4) assess patient reported changes in pain.~     Findings will potentially lead to insights as to the benefit of applying this intervention~     to additional body regions.~   "
42654|NCT02498691|"~     Endometriosis is a benign gynecological disease, characterized by the presence of~     endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in~     reproductive age worldwide, with an extensive impact on women's wellbeing and their~     reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the~     disease are well recognized and are fundamentally different from each other: superficial~     peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian~     endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).~      The investigators performed a prospective multicenter comparative study to assess the~     maternal and fetal risks related to endometriosis during pregnancy, regarding disease~     phenotype, This study will evaluate with sufficient power the risk of prematurity and~     obstetrical complications associated with endometriosis according to disease phenotype.~      This study aims to provide new informations to pregnant women with endometriosis, guide the~     monitoring of pregnancy, optimize management strategies based on the nature of complications~     and ultimately to improve the health of women and their unborn child~   "
42655|NCT02498678|"~     The objective of this study is to assess the performance of acceleromyography as a method of~     evaluation of muscle relaxation after application of tetanus stimulation to obtain stability~     of responses before administration of neuromuscular blocking agents.~   "
42659|NCT02498626|"~     This study was designed to examine if venous saturations from the central venous line and~     from the venous side of the heart lung machine are interchangeable or not with mixed venous~     saturation from the pulmonary artery in children undergoing open heart surgery for~     correction of various congenital heart defects.~   "
42660|NCT02498613|"~     This phase II trial studies cediranib maleate in combination with olaparib in treating~     patients with solid tumors that have spread to other parts of the body or cannot be removed~     by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and~     pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the~     flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.~   "
42661|NCT02498600|"~     This randomized phase II trial studies how well nivolumab works with or without ipilimumab~     in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer~     that has not responded after prior treatment (persistent) or has come back (recurrent).~     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different~     ways by targeting certain cells. It is not yet known whether nivolumab is more effective~     with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal,~     or fallopian tube cancer.~   "
42662|NCT02498587|"~     This is a multi-centre, prospective, short period incidence observational study of patients~     in participating hospitals and intensive care units (ICUs) with SARI. The study period will~     occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5~     to 7-day cohort study in which patients meeting a SARI case-definition, who are newly~     admitted to the hospitals / ICUs at participating sites, will be included in the study. The~     study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All~     clinical information and sample data will only be recorded if taken as part of the routine~     clinical practice at each site and only fully anonymised and de-identified data will be~     submitted centrally.~      The primary aim of this study is to establishing a research response capability for a future~     epidemic / pandemic through a global SARI observational study. The secondary aim of this~     study is to investigate the descriptive epidemiology and microbiology profiles of patients~     with SARI. The tertiary aim of this study is to assess the Ethics, Administrative,~     Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.~   "
42663|NCT02498574|"~     A promising form of enhancing brain function non-invasively involves stimulating the brain~     using weak magnetic or electric currents. This method is becoming increasingly popular in~     both clinical and commercial circles; a number of portable, at-home devices are available on~     the commercial market for personal use. In this study, the investigators aim to determine~     factors associated with the enhancement of cognitive and motor learning following~     transcranial direct-current stimulation in healthy young adults. Understanding how~     participants respond to brain stimulation is critical to maximizing the effectiveness of~     stimulation and determining its potential as a performance-enhancing aid for mental tasks.~     Future developments of this study may also inform the capacity of brain stimulation to act~     as non-drug alternative to treatment for cognitive decline.~   "
42664|NCT02498561|"~     Obesity may affect periodontal health by inducing gingival oxidative damage through~     increased production in circulating reactive oxygen species (ROS). Previous studies have~     reported decreased glutathione levels in patients with periodontitis when compared to~     healthy subjects in gingival crevicular fluid (GCF), plasma and saliva. In the present study~     we hypothesized that high ROS levels in circulation may decrease glutathione levels in the~     GCF,plasma and saliva in obese patients with chronic periodontitis, whereas periodontal~     therapy could have positive effects on glutathione levels.~   "
42665|NCT02498548|"~     This project will characterize lower extremity eccentric muscle function among individuals~     who have undergone locomotor training after spinal cord injury and will evaluate the effect~     of downhill training at moderate speeds - targeted to rehabilitation eccentric function of~     the knee.~   "
42666|NCT02498535|"~     Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing~     over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo~     control arm.~   "
42667|NCT02498522|"~     The aim of this work is to study the effect of metformin use for reducing early pregnancy~     loss in pregnant patients with Polycystic ovary syndrome (PCOS).~   "
42668|NCT02498509|"~     Clinical Trial to Evaluate the Efficacy and Safety of CKD-342~   "
42669|NCT02498496|"~     The purpose of this study is to assess whether administration of a bolus dose of MgSO4~     (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the~     management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the~     emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the~     bronchospasm, and a reduction of the dead space, translating to the following clinical~     outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of~     hospitalisation + LOS + readmission for AECOPD.~   "
42670|NCT02498483|"~     Infants do not routinely receive acetaminophen for pain control after circumcision. This~     study will determine if acetaminophen is effective at controlling infant pain after~     circumcision using nerve block and oral dextrose. Infants will undergo the routine~     circumcision procedure , and half will be randomly selected to receive half acetaminophen~     immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,~     respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary~     cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated~     pain scoring system based on the appearance of the infant. A reduction in NIPS for those~     infants who receive acetaminophen versus nothing will be our primary outcome to determine if~     our study is significant.~   "
42671|NCT02498470|"~     The registry study is to obtain the state of the percutaneous coronary intervention state~     treatment for coronary heart disease in the center of the first hospital of sun yat-sen~     unversity in a real world.~   "
42672|NCT02498457|"~     This study aim to observe the preventive effect and the long term safety of low calcium~     dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.~   "
43867|NCT02482818|"~     The purpose of this study is to determine if Pregabalin, a medication used for the treatment~     of seizures and chronic pain, can be used to effectively treat people who suffer from~     non-asthmatic chronic cough (cough lasting over 8 weeks).~   "
42673|NCT02498444|"~     The purpose of this study is to test the efficacy of treprostinil in the perioperative~     non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube~     drainage (in days).~      The Fontan operation is performed for patients with single ventricle physiology as the final~     palliation to create a series circulation, with passive systemic venous return to the~     pulmonary arteries and the single ventricle solely providing systemic output.~      Patients undergoing extracardiac Fontan tend to have elevation of Fontan pressures~     immediately following the operation with inflammation from surgery requiring additional~     fluid administration to maintain blood pressure. Increased Fontan pressures and fluid~     overload lead to prolonged chest tube drainage.~      The hypothesis is that treprostinil, a prostacyclin drug that dilates the pulmonary~     arteries, will improve immediate postoperative Fontan pressures. Treprostinil is not FDA~     approved for this use. Anecdotally and in a small case series, prostacyclin therapy has been~     shown to assist in transitioning patients off nitric oxide. The investigators believe that~     this improvement in hemodynamics will decrease duration of chest tube drainage resulting in~     a shorter length of hospital stay.~   "
42674|NCT02498431|"~     The investigators aim to evaluate circulating irisin levels alterations in patients with~     acute myocardial infraction and in patients with coronary artery disease subjected to~     percutaneous coronary intervention.~   "
42675|NCT02498418|"~     The primary objective is to demonstrate rifaximin 200-mg tablets (test) and Xifaxan® 200 mg~     tablets (reference ) are clinically bioequivalent with respect to the clinical cure rates~     when administered 3 times a day (TID) for 3 days in subjects with travelers' diarrhea.~   "
42676|NCT02498405|"~     The primary objective of this study is to determine if the Smartphone electrocardiogram~     (ECG) is an acceptable replacement for a standard ECG in the identification of ST Elevation~     Myocardial Infarction (STEMI).~      Toward this objective, this study involves the following:~        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead~          equivalent ECG on patients presenting with chest pain in which the STEMI protocol was~          activated.~        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead~          equivalent ECG on patients presenting to the Emergency Department for evaluation of~          chest pain, not necessarily presenting with STEMI.~        -  Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who~          are blinded to the initial clinical ECG readings, the type of ECG equipment used, and~          the patient's clinical information.~        -  Assess the operational feasibility of using the Smartphone to obtain 12-lead~          equivalent ECG recordings in patients suspected to have STEMI, and~        -  Determine the possibility of pooling the data obtained from this study with data from~          other institutions conducting identical studies, and developing a future IRB-approved~          protocol and statistical analysis plan to compare the sensitivity, specificity,~          positive predictive value and the negative predictive power of the iPhone ECG, using a~          paired standard 12-lead ECG as the gold standard.~      There will be no therapeutic interventions. A single research-related procedure will be~     required, i.e. an iPhone ECG. Effort will be made to ensure that the performance of this~     procedure will not delay any treatment and/or diagnostic procedures that are part of usual~     or specialized care that the patient requires. Effort will be made to enroll 1 STEMI patient~     for every 2 non-STEMI patients.~   "
42677|NCT02498392|"~     The purpose of this study is to evaluate the efficacy and safety and tolerability of~     JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who~     have had inadequate response to treatment with a selective serotonin reuptake inhibitor~     (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).~   "
42678|NCT02498379|"~     This study is designed to assess the safety, biodistribution and dosimetry of the novel~     atherosclerotic imaging PET radiotracer, Cu[64]-25%-CANF-Comb.~   "
42679|NCT02498366|"~     In order to determine norm values for skeleton muscle disassembly due to physical exertion~     in healthy and trained population, and developing a prediction test for approval for~     rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of~     different physical tests.~   "
42680|NCT02498353|"~     A randomized trial comparing weather preoperative short-course radiotherapy with local boost~     is better than conventional preoperative short-course radiotherapy for local advanced rectal~     cancer.~   "
42681|NCT02498340|"~     Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on~     families in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is~     main food for most families in the region and parents and doctors consider it as a~     prohibited food whatever the genetic or clinical phenotypes. The effective management is~     avoiding a spectrum of food and drugs causing oxidative stress. No data is available about~     the hazards of consumption of non-fava beans diet.~   "
42682|NCT02498327|"~     Chronic Venous Insufficiency (CVI) is impaired venous return which results in lower limbs~     symptoms that include pain, swelling and dermatologic changes. CVI is a condition that~     affects both males and females, but is more prevalent in females due to the effect of~     progesterone on vascular tissue resulting in the dilation of veins. The predisposing factors~     for CVI include: female gender, long periods of standing, decreased physical activity,~     obesity, poor nutrition, metabolic syndrome, tight and restrictive clothing as well as~     advanced age, constipation, pregnancy and ascites. Conventional treatment may involve~     surgery, compression stockings, laser therapy, sclerotherapy and venoactive drugs, which are~     aimed at improving the appearance of varicose veins and decreasing pain and swelling.~      The combination of Red Vine, Butcher's Broom, Horse Chestnut and Vitamin B6 is an over-the~     counter herbal preparation, which is used to treat the symptoms associated with CVI. Studies~     done on each of the preparation's individual constituents demonstrate their efficacy in~     improving blood circulation, thereby alleviating symptoms associated with venous stasis. The~     individual extracts improve venous tone and blood circulation, however there are no studies~     on the combined effect of these individual ingredients and their efficacy on the quality of~     life of females affected by CVI.~      The aim of this study is to determine the efficacy of a combination of Red Vine Leaf~     extract, Butcher's Broom, Horse Chestnut and Vitamin B6 on the quality of life in female~     participants with CVI, using the Chronic Venous Insufficiency Quality of Life Questionnaire~     (CIVIQ-20).~   "
42691|NCT02498210|"~     Poor ovarian response (POR) is one of the major therapeutic challenges in in vitro~     fertilization. Several therapeutic approaches for POR have been explored; yet, a single~     effective strategy has not yet been established. Recently, a live birth was reported after~     ovarian cortex fragmentation and in vitro disruption of the Hippo signaling pathway and~     activation of Akt signaling. During IVM procedure increased mechanical stimulation of the~     ovarian cortex takes place. , with the consequent disruption of the Hippo signaling pathway.~     Our aim is to investigate whether the mechanical manipulation and triggering of ovarian~     cortex caused by IVM can cause ovarian follicular activation and recruitment by the~     mechanisms mentioned above. Thus stimulation in the following regular IVF cycle will result~     in improved ovarian response and increased oocytes yield~   "
42683|NCT02498314|"~     In orthopaedic manual therapy translatoric grades of movement are used to determine the~     intensity of force applied during the mobilization. Different clinical effects are described~     for each translatoric grade of movement but there are not published studies evaluating these~     clinical effects.~      The objective of this trial is to determine if force magnitude during hip traction in~     resting position affects immediate and short-term outcomes (pain, physical function, hip~     muscle length and hip range of motion) in patients with hip osteoarthritis. For this~     purpose, investigators conduct a randomized clinical trial, double-blind (patient and~     physical therapist examiner). Participants entering the study were randomized into 1 of 3~     treatment groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III~     mobilization. Participants attend three sessions on alternate days (monday, wednesday,~     friday) and at the same hour. Measurements are taken prior to treatment, immediately after~     each session treatment.~      The participants are recruited from physiotherapy groups or referred by general~     practitioners and orthopedic surgeons.~      Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed~     envelopes) and independent blocked randomization, using a random number generator.~      One physical therapist enroll patients in the study, while an independent research assistant~     performed the randomization and prepared the sealed envelopes, which are opened after~     baseline data collection by the physiotherapist performing the treatments. Participants are~     treated in a private treatment area and have no knowledge of treatments received by other~     participants.~      A second experienced orthopaedic manual therapist applies the standardized hip traction~     mobilization in resting position at either level of force, during 10 minutes. This amount of~     mobilization is consistent with clinical practice and previous studies in osteoarthritis~     patients.~      Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to~     participant group, performed all measurements.The outcome measures are pain, physical~     function, hip muscle length and hip passive range of motion. Pain is registered with visual~     analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical~     function is registered using Timed Up & Go test (TUG), the 20-Meter Walking Test (20MWT) and~     the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s~     test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion~     is measured using inclinometer or goniometer.~   "
42684|NCT02498301|"~     The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin~     chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed~     setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial~     flora and antimicrobial resistance, and obtain parameter estimates to inform a~     cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this~     study will be used to develop management guidelines for the prevention of TD among deployed~     (United States (US) and United Kingdom (UK) military personnel.~      The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial~     among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once~     daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.~      For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US~     and UK) deploying/traveling overseas will be recruited prior to travel to participate and~     will undergo enrollment procedures as outlined in study appendices. Subjects who are~     eligible and agree to participate will be randomized to receive one of 3 regimens: (1)~     rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while~     deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined~     period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of~     use after return to COO for deployments less than 6 weeks in duration. Clinical and~     laboratory data will be obtained before, during if available and after~     deployment/chemoprophylaxis.~   "
42685|NCT02498288|"~     This is an open-label, crossover, randomized, single dose, three treatments, three periods~     and six sequences, single dosage, balanced study to determine Bioequivalence of~     Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs~     the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test~     medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to~     determine if they are bioequivalent.~   "
42686|NCT02498275|"~     This is an exploratory study to characterize the ex vivo immune response to RO6871765 or~     RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy~     volunteers and chronic hepatitis B (CHB) patients.~   "
42687|NCT02498262|"~     Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and~     Placement (VR4VR) is a project that incorporates Virtual Reality into job training to~     increase job opportunities for people who have physical or mental disabilities. The~     investigators are using Virtual Reality and robotics for job evaluation, training and~     placement of people with disabilities. The investigators' goal is to assess and train people~     in a safe, adaptable, and fun virtual environment similar to a video game.~      This is an interventional study with three target populations: autism spectrum disorder,~     traumatic brain injury, and severe mobility and manipulation impairments. The prototype~     system allows for a wide range of environments with the vocational evaluator easily~     controlling the virtual experience, while the job seekers interact realistically.~   "
42688|NCT02498249|"~     The aim of the present study is to assess the immediate effect of irradiation with low level~     laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the~     amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients~     with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study.~     Each subject will receive two forms of treatment in random order: a single session of LLLT~     and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out~     period will be respected between sessions. Surface electromyography will be used to~     determine nerve conduction velocity and activity in the upper trapezius muscles before and~     after treatment. The outcome measures will be determined by a numerical pain rating scale.~     Comparisons before and after irradiation with LLLT will determine the activity of the upper~     trapezius muscles and the level of pain. The data will be submitted to statistical tests~     considering a p-value of p < 0.05.~   "
42689|NCT02498236|"~     This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two~     proposed measures of target engagement in brain. The targets are (1) the suppression of a~     particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a~     socially relevant form of motion and (2) pupil dilation will subjects identify faces showing~     different emotions.~   "
42690|NCT02498223|"~     In order to reduce the physiological and biomechanical loads that the soldiers are exposed~     to, the investigators want to examine new approaches for distributing the carried loads~     according to measurements that are specific for each soldier (body composition and aerobic~     capacity). A functional index (LCI=load carriage index) will provide the commander a tool~     for better decisions in distributing the same total load among the same number of soldiers,~     according to each soldier's ability.~   "
42805|NCT02496715|"~     This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic~     fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg~     (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients~     with chronic but stable asthma as defined in the National Asthma Education and Prevention~     Program Expert Panel Report 3 (NAEPP 3) guidelines~   "
42692|NCT02498197|"~     There is high prevalence of back pain and neck-shoulder pain among blue collar workers.~     Physical excessive exposures such as heavy lifting or working with a bended or twisted back~     are independent risk factors for back pain among workers in the construction industry.~     Participatory ergonomic initiatives increase the success of interventions aimed at reducing~     physical excessive exposures.~      The objectives are in two phases to; 1) determine which work-tasks in selected job-groups~     involve the highest load of the back and shoulders during a normal working day (using EMG,~     Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical~     workloads, drawing on information from objective measurements from phase 1.~   "
42693|NCT02498184|"~     This is a double-blinded, randomized, controlled study on the effect of perioperative~     acupuncture on pain after third molar extraction.~   "
42694|NCT02498171|"~     This study is aimed at evaluating single short spinal technique as a form of labour~     analgesia in a setting where more expensive and labor intensive techniques are not~     feasible.The study will examine the safety and efficacy of two drug combinations~     (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized~     control trial.~      The investigators hypothesize that a single shot of either intrathecal morphine plus~     fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in~     parturients experiencing normal labour.~   "
42695|NCT02498158|"~     Functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and~     healthy subjects) will be assessed using the anatomical and functional MRI scans and~     compared.~   "
42696|NCT02498145|"~     This is a pilot human experimental study to evaluate whether the use of an e-cigarette~     affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in~     active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult~     Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be~     randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care)~     plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine~     e-cigarette.~   "
42697|NCT02498132|"~     Elevated depressive symptomatology is a widespread public health concern and individuals~     with elevated depressive symptoms most frequently report such symptoms to primary care~     physicians (PCPs). PCPs have few evidence-based resources beyond antidepressant medication~     for treating elevated depressive symptoms, which results in negative outcomes for their~     depressed patients. Mobile technologies offer an ideal strategy to meet widespread treatment~     needs. The purpose of the proposed project is to\ customize Behavioral Activation (BA), a~     straightforward, empirically supported treatment for elevated depressive symptoms, for a~     mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their~     patients with elevated depressive symptoms.~   "
42698|NCT02498119|"~     The purpose of this study is to determine whether an increase in lipid bodies in leukocytes~     will lead to an increase in eicosanoid production. The 2nd purpose is to determine if there~     is a significant correlation between lipid body formation and enhanced generation of both~     Lipoxygenase (LO) and COX derived eicosanoids. The 3rd purpose is, if lipid bodies are~     involved in arachidonic acid (AA) metabolism, then AA present in these lipid rich structure~     must be released by phospholipases and the free Arachidonic Acid (AA) must have access to~     the eicosanoid forming enzyme. The fourth objective is to determine the compartmentalisation~     of cPLA2 and MAP kinases including ERK1, ERK2, p85 and p38 are involved in AA liberation~     within lipid bodies.~   "
42699|NCT02498106|"~     The overall goal of this study is to investigate whether the daily administration of~     multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric~     inpatients and will thereby reduce costs of care.~   "
42700|NCT02498093|"~     Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore~     muscular strength or walking speed. Three-5 years after surgery patients are still not fully~     rehabilitated. This study evaluates the effects of maximal strength training on the muscular~     strength in leg press and abduction in patients undergoing THA. Aim of the study is to~     increase the patients physical function through evidence-based rehabilitation in clinical~     practice, with gradually less supervision.~   "
42701|NCT02498080|"~     Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients~     suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of~     limb salvage. During the last decade, drug eluting balloons (DEB) were found to be an~     effective tool for the treatment of atherosclerotic disease in several arterial districts.~     Aim of this study is to compare results of DEB PTA versus standard PTA of infra-popliteal~     district in patients with CLI, from a single-centre prospective randomized trial.~   "
42702|NCT02498067|"~     The investigators will develop a digital application (app)—rPlan dual protection~     (rPlan)—to be used in the clinic waiting room prior to a gynecological and/or contraceptive~     visit. The goal of this research is to develop the app and conduct a feasibility,~     acceptability and effectiveness assessment of rPlan to examine improvement in dual method~     use, enhancement of contraceptive adherence and continuation, increase of condom use and~     decrease of sexually transmitted infection (STI) and human immunodeficiency virus(HIV)~     infection. The research will consist of baseline activities as well as 6 week phone call and~     12 week in-clinic survey and STI test, as well as a retrospective chart review.~   "
42703|NCT02498054|"~     A single visit & single arm study in 80 subjects with diabetes to determine if a short~     educational experience with a new blood glucose meter feature improves the ability of each~     subject to better classify glucose results into acceptable glucose ranges.~   "
42704|NCT02498041|"~     This study evaluates the diagnostic accuracy, safety and acceptability of transnasal~     endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised~     trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be~     randomised to receive either TNE or standard endoscopy followed by the other procedure.~   "
42705|NCT02498028|"~     The aim of this study is to examine the clinical outcome after anterior cervical~     decompression and fusion, and cervical disc prostheses in general. Additionally these two~     surgical methods for degenerative diseases of the cercival spine are analyzed comparatively~     in order to see whether one procedure should be preferred.~   "
43868|NCT02482805|"~     The purpose of this study is to determine whether applying testosterone to virtual~     reality-based cognitive behavioral therapy (CBT) for premenopausal women with social anxiety~     disorder improves treatment outcomes.~   "
42706|NCT02498015|"~     A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid~     substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with~     genotype 1a infection or cirrhosis will receive 12 weeks of open-label~     paritaprevir/ritonavir/ombitasvir and dasabuvir (3D), and twice-daily ribavirin.~     Participants with genotype 1b infection without cirrhosis will receive 12 weeks of~     open-label 3D. The study consists of a screening phase (6 weeks), treatment phase (12~     weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.~   "
42707|NCT02498002|"~     Obesity is a global concern with links to conditions such as diabetes. Historically, these~     conditions have been managed by reducing energy intake on a daily basis, which is often~     hampered by low adherence rates and compensatory reductions in physical activity.~     Intermittent fasting (IMF) has become popular as an alternative method of weight loss, where~     periods of normal eating are punctuated by days of fasting. However, despite its popularity,~     IMF is scarcely examined within the literature.~      This study will examine the impact of IMF on energy balance and the associated health~     outcomes relating to conditions such as diabetes. To achieve this, 36 lean adults and 36~     overweight/obese adults will be recruited, excluding those with conditions which may be~     adversely affected by fasting. Once enrolled, participants will complete a one month control~     phase, incorporating 12 days of diet and activity monitoring, to ensure their weight is~     stable before moving in to the intervention phase.~      The intervention phase will begin with a lab protocol designed to examine body composition,~     resting metabolic rate and metabolic responses to two successive meals. Once completed,~     participants will be randomised to one of three diets which are listed below. Comparing the~     changes seen with diets 1 and 2 will provide the first direct comparison of IMF against more~     conventional strategies, while diet 3 will allow us to ascertain the role of weight loss in~     mediating any effects of IMF.~        1. Daily calorie restriction - Reduce energy intake by 25% on a daily basis~        2. IMF with weight loss - Alternate between 24 hour cycles of fasting and feeding with~          150% of normal intake when feeding~        3. IMF without weight loss - Alternate between 24 hour cycles of fasting and feeding with~          200% of normal intake when feeding~      All three diets will last for 20 consecutive days, with transitions between each 24 hour~     diet cycle occurring at 15:00 each day to allow at least one main meal per day. When~     fasting, participants will only be permitted water and black tea/coffee to eliminate energy~     intake. Once again physical activity and diet will be monitored for 12 days during the~     intervention to examine changes in energy expenditure and ensure compliance.~      Having completed all 20 diet cycles participants will return to the laboratory to repeat the~     protocol described earlier. Comparing these results against the values seen before the~     intervention will then allow the effects of IMF to be identified and compared.~   "
42708|NCT02497989|"~     The purpose of this study is to evaluate the impact of two interventions - Inter-Personal~     Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39~     years for Voluntary Medical Male Circumcision (VMMC) services.~   "
42709|NCT02497976|"~     Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab~     pegol in the treatment of interstitial cystitis/ bladder pain syndrome.~   "
42710|NCT02497963|"~     The purpose of this study is to determine the efficacy and safety of tubularized incised~     plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary~     hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of~     glans ≤ 14 mm, and urethral plate depth shallow o moderate.~   "
42711|NCT02497950|"~     Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.~   "
42712|NCT02497937|"~     This study is a single centre, randomised, double-blind, sponsor-unblinded,~     placebo-controlled, 2 by 2 crossover study in adults with heart failure. In blocking the~     TRPV4 ion channel and reducing pulmonary interstitial fluid, GSK2798745 may improve~     pulmonary function, respiration, and gas exchange as well as sleep-disordered breathing in~     patients with heart failure. Therefore, the current study is designed to investigate the~     effect of repeat administration of GSK2798745 on pulmonary gas exchange and pulmonary~     function.~      A sufficient number of subjects with heart failure will be enrolled so that 12 subjects~     complete the two study periods and critical assessments. Subjects will be randomised to~     receive either GSK2798745 or placebo once daily for a period of 7 days in one treatment~     period and alternate study medication in the second treatment period. Both the treatment~     periods will be separated by a washout period of at least 14-days.~      This study will consist of a Screening visit within 14 days of the start of Period I and two~     treatment periods wherein eligible subjects will be randomised to one of the two treatment~     sequences, a follow-up visit approximately 2 weeks after the completion of second study~     period. The total duration of the study is approximately 8 weeks from screening to follow-up~     visit.~   "
42713|NCT02497924|"~     This study will provide information regarding the metabolic pathway of GBT440, the need for~     evaluation of potential drug-drug interactions, and the need for studies in special~     populations. The administration of radiolabeled drug is necessary to fully characterize the~     rates and routes of elimination of GBT440, providing further quantitative information on the~     disposition of GBT440. The results from this study will permit a comprehensive comparison~     between animal and human routes of elimination and metabolic profiles of GBT440.~   "
42714|NCT02497911|"~     The study is a prospective randomized controlled trial comparing intraarticular catheters~     and adductor canal catheters for postoperative analgesia following a primary Total Knee~     Arthroplasty (TKA).~   "
42715|NCT02497898|"~     The purpose of this study is to study the safety and efficacy of chemotherapy usage followed~     by CIK transfusion in refractory and/or chemoresistant lymphomas.~   "
42716|NCT02497885|"~     The investigators aim to do serosurvey of healthcare-personnel who had participated in~     treatment of confirmed patients of Middle-East respiratory syndrome. The investigators~     collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and~     will collect the post-exposure serum from about 25-30 centers in which confirmed MERS~     patients had been treated.~      The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy~     healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators~     will subdivided the seroprevalence according to the degree of exposure and preparedness of~     personal protective equipment.~   "
42753|NCT02497391|"~     The purpose of this study is to determine if there is any difference in the way the body~     handles 3 types of evacetrapib tablets with different particle sizes. Information about any~     side effects will also be collected. This study will consist of 3 study periods.~     Participants will be dosed 3 times during the entire study. Each study period will consist~     of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the~     day after dosing (Day 2). Then participants will be asked to return to the clinical research~     unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study~     is about 7 weeks from first dose to end of study. Screening will take place within 28 days~     prior to the first dose of evacetrapib and follow-up will take place 21 days after the last~     dose of evacetrapib.~   "
45466|NCT02461888|"~     This study evaluates a new treatment combination of ixazomib with cyclophosphamide and~     dexamethasone in relapsed or refractory multiple myeloma. Participants will either receive~     ixazomib with cyclophosphamide and dexamethasone or cyclophosphamide and dexamethasone~     alone.~   "
42717|NCT02497872|"~     BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography~     (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However,~     early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a~     preventive measure has not been compared to other preventive measures, such as pancreatic~     duct stent placement.~      AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent~     placement in high-risk subjects undergoing ERCP.~      MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two~     tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the~     following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter~     of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm.~     Only those who present a difficult biliary cannulation shall be randomized into two groups:~     those who receive early precut sphincterotomy or those in whom persistency of biliary~     cannulation is intended with subsequent pancreatic duct stent placement after~     cholangiography is achieved. The incidence of post-ERCP pancreatitis as well as other~     complications shall be compared.~   "
42718|NCT02497859|"~     The experiments in this study will assess if while following a reduced energy diet, eating a~     breakfast with higher protein quality will enhance weight loss compared to another breakfast~     with lower protein quality, but matched for energy density and macronutrient composition.~   "
42719|NCT02497846|"~     The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL®~     PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet~     wrinkles.~      It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with~     an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.~      Only, one group of 15 healthy volunteers will be included.~   "
42720|NCT02497833|"~     The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity~     and cholesterol efflux capacity in hypercholesterolemic subjects.~   "
42721|NCT02497820|"~     A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg~     versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline~     pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention~     Programme (CaPP3).~   "
42722|NCT02497807|"~     The purpose of this study is to characterize the functional and anatomical connectivity~     changes in Tourette syndrome and its relation with iron deficiency.~   "
42723|NCT02497794|"~     This study is a randomised controlled trial that included 150 pregnant women undergoing~     cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and~     Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to~     December 31, 2015. After operation, the participants are going to randomly assigned into two~     groups by using cards. The patients are going to randomized into two groups by using a~     sealed enveloped system.The patients in the study group, will chew one sugar less gum for 30~     minutes in postoperative 3., 5. and 7. hours. The control group will be followed without~     chew gum. All patients will note the time of first rumbling of the stomach, first feeling of~     hunger and the first gas outlet.~   "
42724|NCT02497781|"~     This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam~     (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with~     complicated urinary tract infections.~   "
42725|NCT02497768|"~     The investigators want to understand how oral processing (chewing) of nuts affects particle~     size and the presence of lipid (fat) on the cut surfaces.~      The main objective of the study is to:~      Measure the size of nut particles that have been chewed sufficiently to be swallowed.~      The secondary objective of this study is to:~      Measure any changes in lipid content due to chewing and compare it to a prediction from a~     theoretical model.~      The investigators have developed a theoretical model for determining the release of~     nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used~     to calculate the amount of lipid released from chewed almonds. The model shows that only~     about 10% of the lipid is immediately released. The investigators require information on the~     particle size distribution (number of particles of each size) for other chewed nuts to~     calculate the amount of lipid released for other nuts. This will allow us to check the~     validity of our model for other foods.~   "
42726|NCT02497755|"~     This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care~     patients receiving treatment for depression or anxiety delivered in an integrated primary~     care-based behavioral health program.~   "
42727|NCT02497742|"~     Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University~     Medical Center. However, it is unclear how often the second BMP each day is acted on. the~     investigators project aims to answer a few fundamental questions about the need for twice~     daily labs in patients hospitalized with acute/subacute-decompensated congestive heart~     failure who are being actively diuresed.~   "
42728|NCT02497729|"~     The use of a written, pre-procedure checklist and positioning the patient with the head of~     the bed elevated have been proposed as interventions capable of preventing complications~     during non-elective intubation and are used intermittently in routine care -- however~     neither have been examined in a prospective trial.~   "
42729|NCT02497716|"~     To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for~     suspension formulation and to document safety and tolerability~   "
42730|NCT02497703|"~     An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This~     robotic system has been developed to facilitate functional motor recovery by practices~     walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the~     shank and reduce the hyperextension in the knee joint. The robotic knee system is able to~     sense the gait pattern from the stroke patients and assist the walking and control the knee~     angle. The clinical trial will use repeated measurements to evaluate the effectiveness of~     the robotic knee system in gait rehabilitation post stroke.~   "
42731|NCT02497690|"~     This study will assess the effectiveness of post-implant Auditory-Verbal Therapy (AVT)~     delivered by means of telemedicine technology.~   "
42754|NCT02497378|"~     The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414~     (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese~     participants with relapsed (the return of a medical problem) or refractory (not responding~     to treatment) multiple myeloma.~   "
42732|NCT02497677|"~     Infant mental health is a significant public health issue as early adversity and expose to~     childhood stress has life-long consequences for the affected children. Helping families at~     risk correct their adverse effects on the infant has the potential to halt a negative spiral~     effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to~     the child's vulnerability, negatively affects the parents, and so forth. Over a four year~     period, an estimated 17.600 dyads will be screened in the City of Copenhagen using~     standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal~     postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical,~     randomized control trial to test the efficacy of an 8 week group counseling program, Circle~     of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal~     sensitivity, child attachment and cognitive development. CIMHP is the first large-scale~     randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity,~     child attachment and cognitive development in Denmark. Results will provide evidence~     regarding the efficacy of an American short term indicated parenting group program when~     implemented in a Scandinavian country.~   "
42733|NCT02497664|"~     Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment~     of esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical~     resections, and consequently to improve the survival rates. Due to improved survival, it~     will become increasingly important to minimize the radiation-induced toxicity among~     long-term survivors.~      In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is~     the standard treatment modality. However, the dose that can be safely applied to the tumour~     is limited by the risk of cardiac and pulmonary complications, which even led to decreased~     survival in a randomised study, when a higher tumor dose was administered [1].~      Radiation induced pulmonary and cardiac toxicity are the most important late side effects~     after thoracic radiotherapy [2-4].~      The aim of this study is to reduce the radiation dose of heart (and lungs) in order to~     reduce the toxicity risk.~      In recent years, the active breathing control (ABC) technique has been introduced in the~     radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the~     heart. These patients are irradiated in the inspiration phase, in which the distance between~     the heart and the breast is largest, while the lungs extend.~      Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For~     these patients the expiratory phase might theoretically be more beneficial to reduce the~     heart dose. However, the inspiration phase might be better for the dose to the lungs, which~     consequently allows cardiac dose reduction.~   "
42734|NCT02497651|"~     The study aims to evaluate the effect of smoking on postprandial responses such as plasma~     glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy~     smoking men.~   "
42735|NCT02497638|"~     This study is a randomized trial examining the administration of a combination of biguanide~     metformin and atorvastatin (Lipitor) to men who are experiencing rising prostate-specific~     antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).~   "
42736|NCT02497625|"~     This study aims to evaluate the effectiveness of minimal intervention and therapeutic~     alliance in pain, specific and general disability, global perceived effect, empathy,~     credibility and expectation of improvement in patients with chronic non-specific low back~     pain~   "
42737|NCT02497612|"~     Primary Objective:~      To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) is an~     efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and~     children.~      Secondary Objectives:~      To evaluate the efficacy of OZ439 (Artefenomel)/FQ (Ferroquine):~        -  To determine the incidence of recrudescence and re-infection.~        -  To determine the time to relief of fever and parasite clearance.~      To evaluate the safety and tolerability of OZ439 (Artefenomel)/FQ (Ferroquine).~      To evaluate the pharmacokinetics of OZ439 (Artefenomel)/FQ (Ferroquine).~      To explore in vitro drug resistance of P. falciparum infecting patients >14 years old in~     Vietnamese sites.~   "
42738|NCT02497599|"~     Intraoperative tumor localization and resection can be enhanced using intraoperative~     fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic~     anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore~     Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality~     image-guided surgery in RCC.~      The aim of this study is to assess the feasibility and safety of intraoperative~     dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma~     patients.~   "
42739|NCT02497586|"~     Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue~     sample with a needle. Unfortunately, these invasive approaches may be unsafe in many~     patients with lung cancer, who often have co-existing illnesses such as emphysema.~      Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of~     assessing tumour function by measuring concentrations of chemicals (metabolites) within the~     abnormal tissue. It is a well-established technique in imaging brain cancers. It has also~     been more recently studied in assessing prostate, liver and heart. There has been very~     little exploration of the potential role of MRS in lung cancer.~      The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo~     an MRS scan. The reliability of the technique for metabolite measurement will be determined~     by comparing repeated scans from the same region in the same tumour. Further scans from~     different regions in the same tumour, normal lung around the tumour and tumour regions in~     different patients will be used to look for any patterns in the cancer metabolites which may~     indicate avenues for potential future research.~   "
42740|NCT02497573|"~     Around 50% of patients with locally advanced H&N cancer fail to achieve loco-regional~     control. Currently it cannot be predicted, during treatment, who will fall into this group~     of non-responders.~      This study is designed to assess the value of DW MRI as a predictive biomarker of response~     to radiotherapy in intermediate and high risk OPSCC.~   "
42741|NCT02497560|"~     This is a randomized, masked, placebo controlled study to assess the effect on a nutritional~     dietary supplement on menopausal signs and symptoms in perimenopausal women.~   "
42755|NCT02497365|"~     This is a study comparing a new treatment for bacterial keratitis (also known as corneal~     ulcers) with the current standard of care. It is a randomized trial, and the investigators~     plan to test whether besifloxacin (a new antibiotic) in comparison to the current standard~     of treatment, fortified antibiotic drops (cefazolin and tobramycin).~   "
42742|NCT02497547|"~     Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal~     atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort.~     Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier,~     and less elastic due to lack of estrogen. In addition, vaginal atrophy is associated with an~     increased pH, which creates an environment more susceptible to infections.~      Menopausal hormone therapy is a common treatment for vaginal atrophy. However, menopausal~     hormone therapy has been shown to coincide with an increased incidence of breast cancer,~     heart attack and stroke. Some women experience adverse reactions such as uterine bleeding,~     perineal pain, and breast pain with menopausal hormone therapy. Many women are also~     reluctant to initiate estrogen treatment, due to a general negative view of menopausal~     hormone therapy in the society. There are also many contraindicated conditions like~     undiagnosed vaginal bleeding, thromboembolic disease, breast cancer, other~     estrogen-sensitive cancers, or liver disease. Women suffering from vaginal atrophy and~     presenting with these conditions have extremely limited options for effective therapy.~      Oxytocin is a peptide hormone, normally released into the circulation via the pituitary.~     Oxytocin has been shown in vitro to exert positive effects on the proliferation of human~     vaginal mucosal cells from postmenopausal women. Local application of oxytocin, in the form~     of a vaginal gel, Vagitocin, has been investigated in previous studies on postmenopausal~     women, as a new effective and safe option for the treatment of vaginal atrophy. Vagitocin~     appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal~     growth, reducing symptoms of vaginal atrophy and increasing the patients' wellbeing and~     quality of life. Overall, treatment with Vagitocin was safe and well tolerated by the~     subjects in the studies.~      In this study, the clinical efficacy of Vagitocin as a potential treatment for~     postmenopausal women suffering from moderate to severe symptoms of vaginal atrophy, vaginal~     irritation/itching and vaginal discomfort and/or pain associated with sexual activity will~     be explored. In addition, the dose relationship and lowest effective dose of Vagitocin will~     be investigated.~   "
42743|NCT02497534|"~     The purpose of this project is to characterize measures of cardiac performance and~     neuromuscular physiology in FA patients using novel techniques, including echocardiography~     and magnetic resonance imaging (MRI), metabolic exercise testing, and neurophysiological~     outcomes.~   "
42744|NCT02497521|"~     The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric~     study of patients suffering from ADPKD that are considered for tolvaptan treatment. All~     ADPKD patients that are evaluated for treatment indication, or that are planned to be~     treated with tolvaptan, or that are already treated with tolvaptan are eligible. This~     registry is designed to provide real-world data on treatment management of patients with~     ADPKD.~   "
42745|NCT02497508|"~     This is a prospective, single arm, phase II trial in previously treated patients with MPM~     who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic~     biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.~      The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks~     when compared to DCR of patients treated with best supportive care based on historical~     controls.~   "
42746|NCT02497495|"~     Introduction: immersion cold water is a recuperative strategy commonly used, however, are~     not yet fully understood the real effects of this technique on specific conditions.~     Objective: To analyze and to compare the effects of the immersion cold water during the~     intense post-exercise recovery, using different times and temperatures on biological,~     clinical and metabolic variables. Method: 105 male subjects were divided into five groups:~     one control group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1~     degrees Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The~     volunteers were submitted an exhaustion protocol that consisted of a program of jumps and~     the Wingate test. Immediately after the exhaustion protocol, volunteers were directed to a~     tank with water and ice, which were immersed up to the height of the anterior superior iliac~     spine to the recovery procedure, during which blood samples were collected for later~     analysis lactate and creatine kinase (CK). Variables were collected prior to the exercise,~     24, 48, 72 and 96 hours after the end of it. Furthermore, the perception of pain and~     recovery of the lower limbs were also collected at specific moments by means respectively of~     the Likert scale of perceived effort and visual analogue scale pain. Appropriate statistical~     analysis was used to compare the groups and the moments, considering the 5% level of~     significance.~   "
42747|NCT02497469|"~     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous~     (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment~     period.~   "
42748|NCT02497456|"~     The purpose of this study is to evaluate the impact of follow-up counselling after HIV~     diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to~     pre-antiretroviral therapy (pre-ART) care in Uganda.~   "
42749|NCT02497443|"~     • The goal of this study was to evaluate the safety and efficacy of autologous MSC~     application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old)~     patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per~     month) seizures were included in this study. The pts were randomized to the standard~     treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus~     autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group~     received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one~     subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the~     unfavorable reactions to MSC infusions and the clinical effects, including complications,~     were examined. The unfavorable reactions to the MSC injections included local pain or~     hemorrhage at the site of injection and systemic reactions of the central nervous system~     (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy~     in the two groups of pts were examined based on clinical observations and~     electroencephalography measurements (prior and 12 months after the application of the~     MSC-based therapy). To determine potential changes in disease progression, the signs of~     cognitive impairment, behavioral disorders, and particularly, changes in seizure character~     and frequency were evaluated using the National Hospital Scale of Seizure Severity. The main~     points of disease monitoring were yes or no responses (to therapy), seizure frequency~     (per month), and remission of disease. Electroencephalography (EEG) recordings were~     performed to evaluate electrical alpha, beta, theta and delta waves based on standard and~     additional criteria. The paroxismality index, the peak frequency of EEG activity, the index~     of slow activity, and the summarized points of EEG pathology signs were calculated for each~     patient. All assessments were performed for the pts in the control and study groups, and the~     obtained data were compared to identify the potential differences between the two pts~     groups. Therapy was terminated when immediate unfavorable reactions to the MSC injections~     were observed. The final observation of each patient included clinical and EEG assessments~     at the time point of 12 months (or more) after the application of the MSC-based therapy.~   "
42750|NCT02497430|"~     The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B~     Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs~     obtained from pregnant women between 35 - 37 weeks gestation.~   "
42751|NCT02497417|"~     The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test~     for the direct detection of C. difficile nucleic acid in stool specimens.~   "
42752|NCT02497404|"~     The purpose of this study is to determine whether 5-Azacytidine priming before the~     conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an~     effective treatment for high risk myeloid malignancies in complete remission (CR).~   "
42766|NCT02497222|"~     This study evaluates the use of RNS60 in the treatment of asthma examining regional~     improvements in inflammation using PET imaging. All subjects will be treated with both RNS60~     and placebo in a crossover design.~   "
42756|NCT02497352|"~     To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile~     and anthropocentric measurements in subjects with metabolic syndrome, in a randomized,~     open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received~     30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks.~     Both groups will be advised to follow an energy balanced diet and physical activity~     recommendations. Parameters related to metabolic syndrome will be measured at the baseline~     and at the end of the study.~   "
42757|NCT02497339|"~     This study has the following objectives:~        1. To raise the awareness of female smokers about the harmfulness of tobacco towards their~          life issues~        2. To encourage female smokers to stop using tobacco~        3. To assess the effectiveness of mindfulness approach for smoking cessation in women~      We will use cluster randomisation. About 40 companies (5 smokers / company) involved in the~     study will be matched on the company characteristics (e.g. company size, the industry the~     company belongs to). Using random generator in Excel, random number will be first generated~     to each pair i.e. there will be 1-40 random numbers. For each pair, the two companies will~     be randomly assigned to 0 or 1. Companies who are assigned to 1 will be allocated to~     intervention . Interviewers (assessors) in the follow-ups will not be involved in the~     randomization process and be totally blinded to the group assignment (allocation~     concealment).~      Invitation letter will be sent to beauty and retail industries or other women-related~     industries by Lok Sin Tong. Health talks on smoking and its hazard will deliver to each~     company. For those who join the workshops after the health talks will fill in pre- and post-~     workshop questionnaires (Appendix 4-5). Women who attend the health talk will be recruited~     on site. Women will be screened by the criteria of eligibility form (Appendix 1) and all~     eligible women smokers will be asked to sign on informed consents (Appendix 2, 3) before~     they participate in the programs. After they consent to participate, they will fill in a~     baseline questionnaire (Appendix 6), and will be assigned to intervention or control group~     according to the allocation of their company. Some of the eligible women may miss the health~     talks and directly join the intervention program, because of this situation the intervention~     group will be further divided into Group A and B: women in Group A will attend health talks~     and intervention program, women in Group B will only attend intervention program.~      Intervention group (Mindfulness Smoking cessation program): Women in intervention group will~     be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2~     hours with 8-20 participants. For mindfulness training, it aims to understand women smokers'~     own life planning, stressors and their correlation with smoking; to help women smokers sit~     with negative affect and alleviate stress through mindfulness; to educate women smokers gain~     the self-control and replace the smoking habit; to teach women smokers how to prevent~     craving and relapse. The tentative agenda is shown below:~      Session 1 (Introductory) Contents~        1. Pre-questionnaire~        2. Introducing mindfulness and managing craving with mindfulness~        3. Understanding the components of craving and its management~             -  The relationship between habitual response and learned association~             -  The physiological and psychological withdrawal symptoms~        4. Mindfulness yoga practices~      Responsible person* Smoking Cessation Program in Workplace (SCPW) staff & Yoga teacher~      Session 2 (Advanced)~      Contents~        1. Knowledge about impacts of smoking on women's health~        2. Recapture the management of craving through mindfulness~        3. Mindfulness exercises~        4. Mindfulness yoga practices~      Responsible person* SCPW staff & Yoga teacher~      * SCPW staff would be responsible for the whole session except for the part stress~     reduction and self-control through mindfulness yoga. It would be held by the yoga teacher.~      Control group (Self-help smoking cessation booklet): Only the self-help booklet related to~     quitting will be provided to the participants.~      Evaluation: 1-month telephone interviews will be conducted for control group at 1- (Appendix~     97) and 6-month follow-ups will be conducted for both groups (after the last interventions)~     by trained interviewers (blinded to the group assignment). Participants who have reported~     abstinence in past 7 days from smoking at 6-month follow-ups will undergo a non-biochemical~     validation to check their quitting status. They will be invited to have biochemical~     validation tests (saliva cotinine test and exhaled CO test) at 6-month follow-up.~      In-depth face-to-face interview will be conducted by trained interviewers in 10 randomly~     selected participants in each group (in total 20 participants) to better understand their~     quitting process, quitting difficulty, and their own feeling and experience in the project.~   "
42758|NCT02497326|"~     Pain Associated with partial thickness burns (PTB) is very severe and distressing for the~     patients.Topical conventional treatment of superficial PTB wounds includes application of~     polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are~     treated with silvazine cream twice a day and prepared for grafting if not healed within 3~     weeks. Existing conventional therapy is un-comfortable and expensive for the patients.~     Search continues for a reliable, safe, cheap and effective treatment of burn.Topical use of~     heparin has been found effective in reducing pain associated with burn wounds. More over use~     of heparin topically in burn patients is easy to perform and cheap but at the moment,~     evidence of its effectiveness is weak. Current study is being conducted to verify clinical~     effectiveness of use of heparin in 2nd degree burns by comparing it with topical~     conventional treatment.~   "
42759|NCT02497313|"~     Accumulating evidence suggests that bile acids in our intestines may constitute essential~     components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile~     acids can lead to changes in gut hormone secretion and consequently affect glucose~     homeostasis.~      The current study is a human interventional randomized controlled cross-over study including~     four study days for each participant. Metformin will be applied as a tool to reduce bile~     acid reuptake in the small intestine; thereby increasing bile acid concentration in the more~     distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin~     has been shown to reduce the active reabsorption of bile acids in the ileum and cause~     increased faecal elimination of bile acids. Clinical data has suggested that metformin~     causes an increase in the postprandial secretion of GLP-1 in humans including patients with~     type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder~     contraction and emptying. The aim is to examine how (and if) modification of bile acid~     reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and~     glucose homeostasis in patients with type 2 diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in gut hormone secretion. The current study will help to clarify~     this hypothesis and improve our general understanding of the association between bile acid~     circulation and signalling, gut hormone secretion and glucose metabolism.~   "
42760|NCT02497300|"~     Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the~     progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists~     have been shown to improve endothelial function, as well as decrease CV mortality and~     proteinuria. The specific biochemical pathways that produce these pharmacological effects~     for MR antagonists, however, are poorly understood. This study investigates the effect of MR~     antagonism on endothelial function in patients with moderate (stage III) CKD using a~     randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if~     spironolactone improves endothelial function as compared to amiloride in patients with stage~     III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial~     function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3:~     To determine if endothelial dysfunction contributes to albuminuria in patients with stage~     III CKD. The clinical relevance is to improve understanding of the mechanisms of kidney~     function decline in CKD in order to develop interventions to delay or prevent dialysis,~     which would translate into alleviating patient suffering, caregiver burden, and health care~     costs.~   "
42761|NCT02497287|"~     The purpose of this open-label, multicenter study is to assess the long term safety and~     efficacy of intranasal esketamine plus an oral antidepressant in participants with~     treatment-resistant depression (TRD).~   "
42762|NCT02497274|"~     The purpose of the protocol is to determine the impact of bariatric surgery on taste~     receptors and taste perceptions and to precise the factors implicated in taste alterations~     in 50 obese patients before and 6 months after bariatric surgery (25 Roux Y gastric bypass~     and 25 sleeve gastrectomy).~   "
42763|NCT02497261|"~     The purpose of this study is to determine if avoidance of peanut by children with positive~     allergy testing to peanut in the first 5 years of life increases the likelihood of~     developing a persistent peanut allergy by age 5 years. To answer this question, the~     investigators need to determine which children with positive allergy testing to peanut have~     reactions after eating peanut (allergic to peanut) and which are able to tolerate eating~     peanut (not allergic).~      The investigators plan to conduct double-blind placebo-controlled peanut challenges (gold~     standard for peanut allergy diagnosis) for CHILD study (http://www.canadianchildstudy.ca)~     participants who had positive skin prick testing to peanut at ages 1, 3 or 5 years (in other~     words, children who are sensitized to peanut, but may or may not be allergic to peanut) and~     who are avoiding peanut without ever having had a reaction or whose history suggests that~     they may have outgrown a known peanut allergy. These challenges will not change a child's~     ability to tolerate peanut, but will determine if children who are avoiding peanut are~     allergic to peanut (and need to continue avoiding peanut) or clinically tolerant to peanut~     (and may continue to eat peanut after passing the challenge).~   "
42764|NCT02497248|"~     Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have~     a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the~     therapy of choice in drug-refractory patients. Recent studies have shown that ablation have~     a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of~     rotors. The non-invasive identification of specific mechanism of AF maintenance in each~     patient could allow the selection of the most appropriate treatment.~   "
42765|NCT02497235|"~     The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H)~     enzyme occupancy of TAK-935 after single oral dose in healthy participants using the~     positron emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the~     relationship of occupancy to TAK-935 exposure.~   "
42767|NCT02497209|"~     Aim: To collate data on Anogenital Distance (AGD) from several population studies to build~     an international database for Anogenital Distance (AGD) Primary objective: To build a~     database platform to promote and facilitate international collaboration on research related~     to AGD, endocrine disruptors and reproductive health.~      Study Design Observational study Outcome Measures Outcomes from varying projects based on~     the database~      Summary of eligibility criteria Population studies with subjects in whom data on AGD is~     available~      Procedures:~      An international AGD database will be set-up with an appropriate dataset for the research~     projects. This will be based on anonymised data from multiple population studies. In order~     to facilitate and provide a governance structure for the study, an international AGD~     consortium will be established.~   "
42768|NCT02497196|"~     This study investigates comparing the effects of transcranial Pulsed Current Stimulation and~     transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on~     neurophysiological outcomes on healthy subjects as well as on the clinical population for~     chronic visceral pain. The study also aims to evaluate the effects of these techniques on~     pain thresholds in healthy subjects as well as for chronic visceral pain patients.~   "
42769|NCT02497183|"~     Acute appendicitis is the most common cause of abdominal pain requiring surgical~     intervention.~      The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its~     effectiveness, the test involves exposure to a high dose of radiation.~      Using ultrasound to diagnose this condition has been described extensively in the medical~     literature, and this test has a very high specificity (over 95%), however sensitivity of the~     test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test~     include operator dependency as well as factors such as body habitus of the patient, presence~     of technical disturbances (artifacts) caused by gas in the large intestine and inadequate~     cooperation from the patient during the exam. All of these factors may affect the ability to~     detect sonographic signs of appendicitis.~      The investigators believe that it is possible to reduce the amount of artifacts caused by~     the presence of gas in the intestine by filling of the colon with liquid suspension that is~     routinely given in the investigators' hospital before performing an abdominal CT and~     performing an additional ultrasound scan to those patients in which the initial ultrasound~     examination (without any preparation) proved to be equivocal or not diagnostic.~      The target population for the study is any patient who arrives to the emergency room with~     complaints of right lower quadrant abdominal pain and it is decided by the referring~     physician in the ER to start diagnostic workup for suspected appendicitis by performing an~     ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is~     decided that the patient needs to continue investigation by performing a CT scan, the~     patient will receive contrast material orally for approximately 180 minutes and prior to the~     CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the~     repeat ultrasound will allow a statistically significant improvement in the detection rate~     of the appendix.~   "
42770|NCT02497170|"~     Translational study based on the American Association of Diabetes Educators 7 behaviors to~     manage Type 2 diabetes~   "
42771|NCT02497157|"~     The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU),~     levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate~     (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who~     harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or~     *1/*28.~   "
42772|NCT02497144|"~     Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception~     and hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired~     ventilatory response, increased lung compliance, ventilation-perfusion mismatching and~     inadequate peripheral circulation causes decreased exercise capacity. Another important~     factor that induce decreased exercise capacity is peripheral muscle weakness. In literature,~     there is no study investigated effects of neuromuscular electrical stimulation on functional~     exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical~     activity level, dyspnea and fatigue perception in patients with interstitial lung disease.~   "
42773|NCT02497131|"~     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and~     safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL~     patients.~      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of~     anti-cancer activity will be assessed using the revised response criteria for malignant~     lymphoma (Cheson et al. 2007).~      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be~     performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment~     (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with~     at least stable disease will enter short follow up phase till month 24 with radiology~     assessment every 6 months and visit every 12 weeks. After month 24 and for all patients with~     progressive disease, long-term follow-up assessments (including survival, disease status and~     next therapy information) will be performed every 12 weeks until either patient death or~     study closure, whichever occurs first.~   "
42774|NCT02497118|"~     This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with~     vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung~     cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with~     neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate~     and the rate of resection, At the same time, the study before and after the anti~     angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs),~     levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular~     endothelial growth factor(VEGF) expression level, to understanding the correlation between~     the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change~     of all these markers. In order to find the reference basis for the prediction of the effect~     of curative effect. The changes of blood volume, blood flow and vascular permeability of the~     lung cancer before and after treatment with CT perfusion imaging are studied.~   "
42775|NCT02497105|"~     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,~     and moderate protein) in treating epilepsy. Two study groups will be comprised of children~     with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet -~     epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.~   "
42776|NCT02497092|"~     The purpose of this study is to determine whether certain intravitreal injection techniques~     cause less pain than others and would therefore be beneficial for the patient's well being.~   "
42777|NCT02497079|"~     The purpose of this study is to compare the diagnostic efficacy of nested and realtime~     polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients~     with isolated intrathoracic lymphadenopathy.~   "
43305|NCT02490176|"~     Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and~     GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.~     The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters~     in patients with heart failure.~   "
42778|NCT02497066|"~     The main objective of this protocol is to determine the effectiveness of using compounded~     topical pain creams for treating neuropathic, nociceptive, or mixed-pain syndromes. Since~     these compounded pain creams may be associated with burning or irritation at the application~     site, and possible systemic effects may present, the secondary objective is to determine the~     relative satisfaction with the creams. The investigators hypothesis is that the active pain~     creams may provide significant benefit compared to placebo cream.~      3.1 Specific Aims~        1. Specific Aim 1 will determine pain relief following treatment with the appropriate~          (based on specified pain) compounded topical pain cream or a placebo cream. The~          investigators hypothesis is that the compounded topical pain creams will provide~          greater pain relief than placebo creams.~        2. Specific Aim 2 will measure the patient satisfaction with the cream (compound or~          placebo). The investigators hypothesis is that the compounded topical pain creams will~          improve patient satisfaction, while the placebo cream will not result in a change in~          patient satisfaction with their pain treatment.~   "
42779|NCT02497053|"~     The prognosis of mesothelioma is generally poor. The median survival of patients with~     unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is~     poor because there is no curative treatment.~      Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality~     treatment regimens have been reported to prolong survival. Other new therapeutic approaches~     include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and~     photodynamic therapy, but the results have not yet been completely validated. Even with the~     introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean~     survival of 12 months. The current standard of care for unresectable malignant pleural~     mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a~     study including 448 patients from 19 countries which was the largest trial to date among~     patients suffering from malignant mesothelioma. Results showed statistically significant~     increase in overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3~     months for cisplatin alone. In addition, there was an improvement in lung function (forced~     vital capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.~      Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in~     malignant mesothelioma and there are no approved predictive markers for response.~      Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable~     toxicity and so we need to rationalize its use in our Egyptian patients.~      Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of~     pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for~     response.~   "
42780|NCT02497040|"~     Ninety American Society of Anesthesiologists (ASA) Physical Status classification system~     I-II patients were recruited for a randomised, placebo-controlled, double-blind study and~     were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group~     B; n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C;~     n=30). Scalp block was performed 5 min before head pinning. Systolic, diastolic and mean~     arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation and end-tidal carbon~     dioxide were recorded. Postoperative pain was evaluated using a 10-cm visual analogue scale~     (VAS).~   "
42781|NCT02497027|"~     This is a randomized, control group design of pharmacogenetic implementation in a mental~     health population of subjects taking anti-depressants and/or anti-psychotics with a new or~     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive~     Disorder Not Otherwise Specified (DDNOS).~   "
42782|NCT02497014|"~     The objective of the study is to investigate clinical outcomes following single versus dual~     stenting strategies for the treatment of true bifurcation distal left main coronary artery~     lesions.~   "
42783|NCT02497001|"~     Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®~     Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.~   "
42784|NCT02496988|"~     The purpose of this study is to determine whether combining of Temozolomide and~     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of~     Malignant Glioma is also evaluated.~   "
42785|NCT02496975|"~     This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and~     traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for~     other diseases, but is not approved by the Food and Drug Administration for treatment of~     traumatic brain injury. The effect of Cyclosporine A on chemicals produced following brain~     injury is being determined using doses no larger than those used for patients having organ~     transplant. It is also being given for a much shorter time period (3 days). It is not know~     if side effects seen in patients taking cyclosporine A will occur when it is given for only~     3 days. It is not known if patients with brain injury that are treated with cyclosporine A~     will have side effects like those seen in organ transplant patients.~   "
42786|NCT02496962|"~     This study aimed to investigate the effect of 48-h sleep deprivation on heart rate~     variability (HRV) in young healthy people and the protective effect of statin on arrhythmia~     and HRV.~   "
42787|NCT02496949|"~     to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of~     Icaritin in advanced solid tumor patients in China~   "
42788|NCT02496936|"~     The influences of specific dietary fat sources on satiety, appetite and energy utilization~     remains unclear; evidence is lacking on whether responses vary according to acute intake.~     The researchers will use a controlled setting to determine whether the source of dietary fat~     is related to perceived satiety, satiety hormone responses, and energy expenditure by~     conducting experiments to evaluate short term (acute) effects.~   "
42789|NCT02496923|"~     Background:~      High risk patients with lung disease who undergo cardiac surgery are at significant risk of~     postoperative complications leading to prolonged hospital stay. One method of reducing the~     risk of lung complications is to treat patients with non-invasive ventilation or continuous~     positive airways pressure postoperatively. However, this often requires admission to a high~     dependency unit or intensive care, and is uncomfortable because of the need for a tight~     fitting mask, as well as being labour intensive and costly. Nasal high flow oxygen~     (Optiflow™) is a new alternative as it provides warmed humidified oxygen at high flow, and~     also has been shown to assist breathing and improve recovery. It is comfortable during use~     and indeed may be more comfortable than standard (dry) oxygen via a facemask (Hudson type)~     or nasal prongs. It may be administered on a normal ward, however its routine use in high~     risk patients with lung conditions such as asthma, chronic obstructive pulmonary disease,~     recent chest infections and heavy smokers has not been tested before.~      Aims/Objectives:~      The primary aim of this clinical trial is to determine if prophylactic nasal high flow~     oxygen (Optiflow™) therapy in cardiac surgical patients at high-risk of developing~     post-operative pulmonary complications is associated with shorter hospital length of stay.~      Methods:~      High risk adult patients who are scheduled to undergo cardiac surgery will be recruited with~     full ethical approval and informed consent. Before surgery, each patient will perform a 6-~     minute walking test under the supervision of a physiotherapist. This simple tests measures~     how far patients can walk in 6 minutes. Additionally, patients will undergo spirometry~     testing which is used to assess how well the lungs work by measuring how much air the~     patient inhales and exhales and how quickly they exhale. Patients will thereafter undergo~     surgery under general anaesthesia as they would normally. After the operation they will be~     looked after following our recovery protocols, incorporating pain relief, regular~     physiotherapy, early mobilisation and eating and drinking, and removal of chest drains and~     tubes as soon as possible.~      On arrival in the critical care area after their surgery, patients will be randomly assigned~     to receive supplemental oxygen via a soft facemask (Hudson Type) (standard group), or via~     high-flow nasal cannulae(Optiflow™) (intervention group). Patients will be administered~     oxygen for at least 24 hours after surgery.~      Patients who develop breathing difficulty will receive treatment based on their clinical~     need. On the fifth or sixth postoperative day they will repeat the walking test and~     spirometry. The investigators will use a short questionnaire to determine if there is any~     difference in how patients feel they recovered before they leave hospital and how quickly~     they returned to normal activities after discharge, and also to evaluate how they tolerated~     either the facemask (Hudson Type) or high flow nasal cannulae (Optiflow™).~      The investigators have used data from previous studies to calculate that a total of 74~     patients will be needed to take part, in order to evaluate whether high flow nasal oxygen~     (Optiflow™) leads to reduced length of hospital stay after high risk cardiac surgery~     compared with usual care oxygen therapy.~   "
42790|NCT02496910|"~     This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover~     design.~   "
42791|NCT02496897|"~     This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B~     vaccine, administered as an add-on therapy to entecavir or tenofovir. Seventy-two~     HBeAg-negative subjects will be randomized to receive low or high dose vaccine, in the~     presence or absence of IC31® adjuvant, or to receive placebo or IC31® adjuvant alone.~   "
42792|NCT02496884|"~     DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia pain. Because it is~     metabolized through the kidneys, people who have reduced kidney function will not process~     the drug as well as with those with normal kidney function, so the dose must be reduced.~     This study will test two reduced dose levels for both moderately reduced and severely~     reduced kidney function. The study will test the hypothesis that the drug will be safe and~     well-tolerated in people who have both fibromyalgia and chronic kidney disease.~   "
42793|NCT02496871|"~     The purpose of this study is to compare two different weight management delivery methods,~     social media versus a traditional care model.~   "
42794|NCT02496858|"~     The aim of this study is to identify genetic loci,or gene variations contributing to the~     development of coronary artery disease (CAD) in Chinese young adults. Investigators will~     compare coronary angiogram results to genetic findings within young CAD patients.~   "
42795|NCT02496845|"~     VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the~     treatment of ED.~   "
42796|NCT02496832|"~     Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is~     believed that looking for low levels of oxygen (hypoxia) in tumours may give a better~     understanding of how certain tumours grow or respond to certain treatments. This study will~     look at hypoxia in pancreatic tumours while participants are receiving treatment with the~     combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.~      This study will use positron emission tomography (PET) scans to look at hypoxia in tumours.~     PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a~     radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to label areas of~     hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans~     and comparing these levels with the patient's response to treatment with gemcitabine and~     TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship~     between hypoxia and response to this treatment.~      The main purpose of this study is to see how useful looking at hypoxia in tumours are when~     they are done at different centres.~   "
42797|NCT02496819|"~     Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in~     160 children for the age group of 6-12 years old in Australia are diagnosed with ASD.~     Children with ASD have impairment in two common areas including: i) social and communication~     and ii) repetitive and stereotypical patterns of behaviours. These common features result in~     behavioural problems which negatively impact children's participation in school, activities~     of daily living and social engagement.~      Therefore, there is a need for effective interventions to overcome the behavioural problems~     in children with ASD.~      The purpose of the study is to investigate the effect of sensory integration (SI) and~     self-regulated learning versus an activity-based control programme in reducing behavioural~     problems in children with ASD that interfere with their daily livings, school, and social~     engagement.~      The study will adopt a randomized controlled trial design with three intervention groups: I)~     self-regulated learning, II) sensory integration and III) activity-based intervention as the~     control group.~   "
42798|NCT02496806|"~     Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols~     which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight.~     Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins~     and their bioavailability and bioactivity. The purpose of this study is to investigate the~     absorption and metabolism of seaweed polyphenols in humans. As part of an EC project~     (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/~     bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy~     volunteers that consumed a seaweed capsule containing polyphenols will be collected before~     and after the intervention. Data emanating from this project will provide strong scientific~     evidence for bioavailability and health promoting activity of a seaweed polyphenol extract~     in human volunteers.~   "
42799|NCT02496793|"~     The goal of this community randomized operations research study was to evaluate the effect~     of a peer-facilitated community support group intervention on uptake of maternal and~     neonatal child health (MNCH) and PMTCT services and on adherence outcomes in Zimbabwe.~   "
42800|NCT02496780|"~     Insulin replacement therapy may be effective in breaking the cycle of protein catabolism,~     undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF~     youth because of its potent anabolic effect. A significant number of CF patients might~     benefit from this therapeutic approach with a substantial impact on morbidity and mortality.~   "
42801|NCT02496767|"~     This study is to assess the effect of tirasemtiv versus placebo on respiratory function in~     patients with ALS.~   "
42802|NCT02496754|"~     Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It~     can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles~     growth evenly.~      At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used~     in around 85% patients in the investigator's center. However, patients have to inject short~     term GnRH-a 0.05mg or 0.1mg daily for around 3 weeks in one IVF cycle.~      Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to~     increase IVF outcome by altering endometrial receptivity. Moreover, it is also very~     convenient because patients do not have to inject GnRH-a daily. In order to make patients~     feel more comfortable during IVF treatment, the investigators have used a new ovarian~     stimulation protocol since the beginning of 2015. The investigators give patients long term~     GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle~     growth around 30 days later based on the hormone levels and follicle size. In the pilot~     observational study of several patients, no LH surge occurred during ovarian stimulation.~      The aim of this randomized controlled study is to compare the efficiency of this new~     protocol and standard GnRH-a long protocol in the investigator's center.~   "
42803|NCT02496741|"~     This phase Ib, open-label, single-center, non-randomized clinical trial will evaluate the~     toxicity and efficacy of metformin and chloroquine in isocitrate dehydrogenase 1/2-mutated~     (IDH1/2MT) patients with a glioma, intrahepatic cholangiocarcinoma or chondrosarcoma.~   "
42804|NCT02496728|"~     The purpose of the study is to investigate the preservation or promotion of health in~     students during the college years.~   "
42806|NCT02496702|"~     This study evaluates the use of Playware technology for balance training. Falling among~     elder is a costly problem. Research shows that training can help prevent falls. Pilot~     studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly~     increase their physical abilities.~      The interventions group will train using interactive modular tiles. The tiles include~     preprogrammed games that create playful training for the participants.~      The control group will receive usual care, which here refers to normal day activities.~      The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and~     each participant receiving 13 minutes of training each time.~   "
42807|NCT02496689|"~     This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene~     mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme~     needed to harden bone. The purpose of this study is to provide access to treatment in a~     disease where no approved treatment exists. This is an experimental treatment provided under~     specific treatment guidelines in which safety endpoints will be collected.~   "
42808|NCT02496676|"~     Background:~      - X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and~     neoplasia syndrome is called XMEN syndrome. In this genetic condition, the cells have less~     magnesium than normal. This makes it hard for the body to fight infections. Researchers want~     to see if magnesium supplements can make it easier for the body to fight infection.~      Objective:~      - To see if magnesium supplements can strengthen the immune system and reduce the amount of~     Epstein-Barr virus in people with XMEN syndrome.~      Eligibility:~      - People ages 6 and older who have XMEN syndrome~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  CT scan: Participants will drink a contrast and may get dye through an IV in the arm.~          They will lie in a machine that takes pictures of the body.~        -  EKG: Small sticky patches on the body will trace heart rhythm.~        -  Blood tests~        -  The study has 2 parts.~        -  Participants doing both parts will participate for 1 year and visit the clinic about 15~          <TAB>times. These visits will include a physical exam and blood and urine tests.~        -  Participants doing only the first part finish in 6 months and have fewer visits.~        -  For study part 1, participants will take magnesium pills for 3 months and placebo pills~          for another 3 months.~        -  At 3 and 6 months, they will have physical exam, medical history, blood and urine~          tests, <TAB>and an EKG.~        -  If the magnesium pills are not helpful, participants will do study part 2.~        -  They will be admitted to the hospital for 4 5 days to get magnesium for 3 days through~          an arm vein.~        -  They will take magnesium pills for another 6 months.~   "
42809|NCT02496663|"~     This phase I trial studies the side effects and best dose of necitumumab when given together~     with epidermal growth factor receptor (EGFR) inhibitor AZD9291 (osimertinib) in treating~     patients with EGFR-positive non-small cell lung cancer that is stage IV or has come back~     (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Monoclonal~     antibodies, such as necitumumab, may block tumor growth in different ways by targeting~     certain cells. EGFR inhibitor AZD9291 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Giving necitumumab with EGFR inhibitor AZD9291 may be a~     better treatment for EGFR-mutant non-small cell lung cancer.~   "
42810|NCT02496650|"~     The objective of this randomized controlled study was to evaluate whether DEX addition to~     benzodiazepine therapy is effective and safe for AWS patients in the intensive care unit~     (ICU). Eligible participants were randomly assigned to intervention (D) and control (C)~     groups. In the group D DEX infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to~     achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus)~     were used wherever DEX infusion was not enough. In group K BZD boluses (diazepam 10mg) were~     used to achieve target sedation level and to control AWS symptoms (symptom-triggered~     administration). The primary efficacy outcomes were 24-hour diazepam consumption and~     cumulative diazepam dose required over the course of ICU stay, secondary outcomes were~     length of ICU stay, sedation and communication quality, haloperidol consumption.~   "
42811|NCT02496637|"~     The proposed study is a randomized clinical trial investigating the effects of a weight gain~     and eating dysregulation prevention intervention among college freshmen women. It will~     compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no~     treatment control group. Appetite Awareness Training approach to increasing eating~     regulation through training individuals to eat in response to their appetite cues rather~     than external or emotional cues.~   "
42812|NCT02496624|"~     The Guided Therapeutics (GTx) program at the University Health Network is a network of~     clinicians, scientists, and engineers focused on the development and translation of~     image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies~     developed within the GTx program include a portable intra-operative cone-beam CT (in~     collaboration with Siemens) that has been evaluated in clinical trials for head and neck~     surgery. The intraoperative imaging has been integrated with tracking and navigational tools~     and optical imaging to provide a general surgical dashboard that is used to improve the~     accuracy of surgical resection.~      A recent addition to the GTx program is the development of the GTx OR, located within the~     general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary~     advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy~     Somatom Flash provides a gold-standard in CT imaging, while the Zeego provides excellent~     3D Cone-beam CT with robotic placement for flexible integration within the operating~     environment. Together, the integration of these 2 components into a single OR enables~     critical evaluation of the limits of CT imaging technology for surgical guidance.~      This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous~     placement and localization of markers for resection of small pulmonary nodules during VATS.~   "
42854|NCT02496065|"~     Surgery is the primary treatment modality for many types of cancer and the extent of~     surgical resection is directly related to patient survival. However, it is often difficult~     for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or~     tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid~     damage to critical normal tissues. The purpose of this exploratory study is to evaluate the~     intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with~     breast cancer.~   "
42855|NCT02496052|"~     To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic~     lysis of intrauterine adhesions.~   "
42813|NCT02496611|"~     Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to~     numerous biological adaptations involving appetite, satiety, and energy expenditure in the~     post- weight loss setting. Following a loss in body weight, peripheral and central~     mechanisms convey a sense that energy reserves have dwindled, activating a strong counter~     response to increase caloric intake. Adolescents with severe obesity are not immune to the~     vexing issue of weight regain. Indeed, only 2% are able to achieve and maintain~     clinically-meaningful weight loss with lifestyle modification therapy. Therefore, novel~     treatment paradigms focused on long-term weight loss maintenance are urgently needed.~     Pharmacotherapy has the potential to prevent weight regain by targeting specific~     counter-regulatory mechanisms in the post- weight loss setting. One of the most promising~     candidates is the glucagon like peptide-1 receptor agonist (GLP-1RA) class, which greatly~     enhanced weight loss maintenance following a short-term low calorie diet among adults with~     obesity. The rationale for focusing on GLP-1RA treatment (BYDUREON™) to prevent weight~     regain is supported by the multiple central and peripheral mechanisms of action targeted by~     this class of drug; many of which specifically address the biological adaptations known to~     induce relapse. The investigators have strong preliminary data demonstrating that GLP-1RA~     treatment reduces BMI in adolescents with severe obesity. Moreover, the investigators and~     others have shown that although meal replacement therapy (structured meals of known caloric~     content) can elicit robust short-term weight loss among adolescents with severe obesity,~     weight regain is a pervasive problem. Therefore, in this clinical trial, our innovative~     approach will utilize GLP-1RA treatment to target weight regain following short-term meal~     replacement therapy in youth with severe obesity. Participants who achieve ≥5% BMI reduction~     during the meal replacement phase will be randomized to GLP-1RA treatment or placebo for an~     additional 52 weeks while simultaneously engaging in lifestyle modification therapy.~     Importantly, this study will also allow us to examine the extent to which GLP-1RA treatment~     addresses mechanisms of weight regain, investigate other pleiotropic benefits of GLP-1RA,~     and identify predictors of weight loss response.~   "
42814|NCT02496598|"~     The purpose of this study is to evaluate the effectiveness of an experimental treatment,~     known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women~     diagnosed with primary ovarian insufficiency (POI).~   "
42815|NCT02496585|"~     The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib~     in combination with steroids, has on the lungs. Furthermore, such treatments' side effects~     will be studied together with quality of life. In addition, the investigators would like to~     determine whether they can find markers in the blood which predict worsening lung injury.~   "
42816|NCT02496572|"~     Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to~     adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a~     minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated~     with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in~     Uzbekistan shows that the current standard treatment greatly limits the ability to scale up~     to meet the high rates of MDR TB in the region.~      Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a~     relapse-free cure rate of 88%. Several countries in West Africa started implementing similar~     regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among~     regions with high second line drug use and resistance is still limited.~      The investigators propose an observational study under programmatic conditions to evaluate~     the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug~     resistant (XDR) TB prevalence and high second-line drug resistance setting of~     Karakalpakstan, Uzbekistan.~   "
42817|NCT02496559|"~     Viral self-limiting infections in respiratory organs among children are common in primary~     care. Serious infections have low prevalence and are challenging to distinguish from~     self-limiting infections.~      Prescription of antibiotics in primary care is still high but stable since 2009 in Norway,~     and 90% of all antibiotics are prescribed in primary care.~      C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in~     primary care, but its role in ruling-out serious infections and the cut-off value for~     prescribing antibiotics has been discussed a lot.~      The aim of this study is to identify if pretesting with CRP of all children 0-6 year with~     fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of~     antibiotics and the referral to hospital for children.~   "
42818|NCT02496546|"~     The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO~     32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.~   "
42819|NCT02496533|"~     This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer~     patients as they undergo radiological examination to evaluate tumor response. Anxiety levels~     will be investigated before massage, after massage, and following the completion of the~     radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will~     be used to measure anxiety.~   "
42820|NCT02496520|"~     Phase I/II, open, prospective clinical trial, historically controlled. The objective is to~     evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment~     based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor~     lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System)~     CNS tumors.~   "
42821|NCT02496507|"~     The purpose of this study is to investigate whether a device that allows office workers to~     sit or stand whilst working can reduce their sitting time at work and improve their health~     over 8 weeks.~   "
42822|NCT02496494|"~     The purpose of this study is to evaluate the effects of conversion from cyclosporine to~     tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal~     transplant recipients.~   "
42823|NCT02496481|"~     This study involves an emergency department (ED)-based intervention utilizing Motivational~     Interviewing (MI) techniques and patient-centered (e.g., tailored) print materials to~     promote the correct and consistent use of size-appropriate child passenger restraints (car~     seats, booster seats, and seat belts). This study is designed as a randomized pilot trial.~   "
42824|NCT02496468|"~     Despite its common occurrence, still little is known about pathomechanisms determining~     different wheeze and asthma trajectories and phenotypes in children, and those beginning in~     adulthood. Therefore, deciphering underlying determinants for different childhood and adult~     asthma phenotypes is urgently needed to develop personalized treatment approaches targeting~     distinct underlying mechanisms. Thereby, secondary prevention early in the disease process~     can also be achieved. The decoding of such mechanisms and their translation to the~     individual patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for~     Lung Research' (DZL).~   "
42825|NCT02496455|"~     The purpose of this study to determine the association between postoperative pain after~     cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.~   "
42856|NCT02496039|"~     6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the~     treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.~   "
42826|NCT02496442|"~     A. Synopsis~        1. This protocol comes to direct the experiment to be performed on the Aqueduct Automatic~          Continuous Irrigation system.~        2. The Aquaduct System is aimed at reducing risks to the patient by decreasing the~          irrigation fluid pressure he may be exposed to, reducing the procedure time and~          therefore the anesthesia time, reducing the manual handling of the sterile bags and the~          risk of contamination and more.~        3. In general since there is no new procedure suggested and the equipment does not~          actually come into contact with the human body in any direct way, there is no need to~          have a clinical study for the regulation purpose. The reason for performing this~          experiment is to demonstrate the new system and to find out the best way to operate it~          in order to improve the process and reduce risks.~        4. This information will serve the development of most suitable automation solution for~          achieving the long desired continuous irrigation.~        5. The experiment will be performed in the OR in MIS procedures, and will replace the~          standard gravitational manual method of performing the irrigation. The surgeons and the~          medical staff of the OR will be directed with the set up and operation of the system~          prior to using it. The experiment will be accompanied at all times with a knowledgeable~          representative of the research originator.~        6. A maximum of 30 procedures will be analyzed during a period of approximately one month.~          The surgeons and the medical staff will report their impression of using the system~          during the procedures and will recommend the best settings achieved.~      This information will be used to improve the system performance and design.~   "
42827|NCT02496429|"~     The primary objectives of this study is to evaluate how professionals rate the reliability~     and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump~     set~      4.2 Secondary Objectives~      The secondary objectives of this study are:~        -  to evaluate the rate of usability problems with the BrownieForSymphony pump set~        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump~          set~        -  to evaluate first impression of lactating woman regarding pumping with the~          BrownieForSymphony pump set~   "
42828|NCT02496416|"~     This study will examine the effectiveness of aquatic therapy on a range of MS-related~     symptoms such as cognition, mood, fatigue and quality of life (QOL).~   "
42829|NCT02496403|"~     This is a randomized trial of two group-based models of care for buprenorphine/naloxone~     (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management~     (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU~     treatment program, where a medical management model of care has not been empirically tested~     with bup/nx patients, and where a high prevalence of patients with co-occurring psychiatric~     and medical co-morbidities are treated. SSM includes brief weekly group-based visits~     consistent with previously studied medical models, and is drawn from primary care bup/nx~     research. IOT is a predominant model of care in specialty treatment, and incorporates~     psychosocial support, 12-step, educational and relapse-prevention based approaches. The~     investigators will recruit 300 adult patients inducted onto bup/nx, randomize them to either~     SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. Study~     investigators will examine the impact of these treatment approaches on 90-day bup/nx~     adherence, opioid and SU abstinence, quality of life, and health care and societal costs.~     Further, investigators will examine whether the effect of IOT versus SMM on adherence and SU~     treatment outcomes is greater for those with medical or psychiatric co-morbidities. This~     innovative approach includes a focus on complex patients with psychiatric and medical~     co-morbidities in specialty care, adapting a care model previously only tested in primary~     care, a 12-month follow-up, no research-forced medication taper, an examination of health~     care and societal costs, and a combination of patient self-report and electronic medical~     record data. Through this approach, the proposed study will yield critically important~     findings on how best to treat complex prescription opioid dependent patients with an~     integrative behavioral services and medication treatment model in SU treatment.~   "
42830|NCT02496390|"~     Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is deposited in the liver.~     Almost all patients also have obesity and insulin resistance (the inability of the body to~     effectively use insulin). Obesity and NAFLD are intricately intertwined and are increasing~     in incidence. While weight loss is the most effective therapy for NAFLD, the investigators'~     efforts are failing and in the next generation it will become the most common cause of liver~     failure in Canada. Recently, researchers have focused on the potential use of altering the~     composition of bacteria in the gut (microbiome) to alter absorption of energy from food,~     deposition of fat and resistance to insulin. This study will determine if transplantation of~     bacteria from the stool of a healthy volunteer into an individual with metabolic syndrome~     and NAFLD (i.e. fecal microbiota transplant/FMT) can alter insulin resistance and reduce the~     amount of fat deposited in the liver. FMT is being studied to treat several clinical~     conditions and is now standard of care for the treatment of refractory Clostridium difficile~     infection. Investigators are proposing a randomized controlled pilot study of FMT in 21~     patients to determine the feasibility and to inform us of changes needed for a larger study.~   "
42831|NCT02496377|"~     Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If~     the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron~     supplementation the patients were randomized to the oral or intravenous (IV) group. The oral~     group received 160 mg ferrous glycine sulfate daily during the month prior surgery,~     associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day -~     14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one~     month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the~     change in Hb level from the day of the preoperative visit to the day before surgery (day-1).~     Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic~     transfusion during and after surgery, and the change in iron indices from the day of the~     preoperative visit to day - 1.~   "
42832|NCT02496364|"~     Lumbar degenerative disease surgery entails in a high blood loss, requiring often for blood~     transfusion. The cost and risks involved in the use of allogeneic blood have motivated~     research methods to reduce operative bleeding in these patients. One such method is the use~     of anti-fibrinolytic drugs, among which is tranexamic acid.~   "
42857|NCT02496026|"~     The objective of the study is to evaluate the effectiveness of transcranial direct current~     stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal~     stimulation on the impaired hemisphere will be used associated with a robotic treatment.~   "
42858|NCT02496013|"~     This is an open-label whole-body PET/CT study for investigation of radiation dosimetry,~     plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in~     healthy volunteers and patients with suspected infection. Changes of routine blood and urine~     tests and any adverse events will be collected from the volunteers. Adverse events will also~     be observed in the patients.~   "
42859|NCT02496000|"~     Randomized, double-blind, placebo-controlled, parallel group study.~   "
42833|NCT02496351|"~     A growing body of literature indicates that up to 80% of amputees may have phantom limb pain~     (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from~     PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The~     etiology and pathophysiology of PLP are poorly understood. Some studies suggest a~     somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a~     analgesic technique. TENS apply a low voltage electrical current through the skin using~     surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of~     evidence to support any treatment for PLP, interest has turned to preventing it instead.~      The aim of this study is to assess if the early use of TENS in the immediately postoperative~     of major limb amputation due to peripheral vascular disease, should decrease the PLP~     incidence. TENS should interfere in the mechanism of PLP production to level of the pain~     fibers conduction.~   "
42834|NCT02496338|"~     The investigators conducted a clinical trial to evaluation the effect of a menopausal health~     training for Husbands of 45-60 years women on the women's quality of life and marital~     satisfaction during transitional period to menopause.~   "
42835|NCT02496325|"~     Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under~     ultrasound-guidance.~      Methods : Successive inclusions after parental consent of 60 children undergoing perineal~     surgery under general anesthesia and pudendal nerve block. Data were collected from~     induction of anesthesia to second post-operative day (24 hrs. after admission in recovery~     room). Ease of PNB achievement was the primary objective evaluated. Efficiency in~     preoperative and postoperative period was also reported.~   "
42836|NCT02496312|"~     The purpose of this study is to provide relevant quantitative evaluation of apathy close to~     real life situation by means of a multimodal sensor system integrated.~   "
42837|NCT02496299|"~     It is a prospective double blind randomized study on the effect of dexamethasone added to~     bupivacaine with plain bupivacaine for caudal block in patient for herniotomy.~      96 patients between the ages 1-6 years will be randomly selected and divided into two~     groups; B and BD.~      Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will~     receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume =~     20mls).~      Data taken will then be analyzed and interpreted.~   "
42838|NCT02496286|"~     This study will evaluate the safety and efficacy of intraperitoneal administration of~     Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive~     intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks~     for up to six weeks, or a maximum of three treatments.~   "
42839|NCT02496273|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA~     specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant~     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.~   "
42840|NCT02496260|"~     Radiotherapy plays an integral role in breast cancer therapy. Multiple randomized studies~     have demonstrated decreased local-regional recurrence rates and decreased breast-cancer~     mortality. However, balanced with this survival benefit is the potential toxicity of the~     treatment itself. In particular, cardiac effects of radiotherapy have been a concern and an~     area of research for the past 20 years. From long-term follow up of patients with lymphoma,~     it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular~     dysfunction, systolic and diastolic function abnormalities, and heart failure among~     cancer-survivors. Patients with breast cancer receive lower doses to smaller volumes of the~     heart, but they also have an excellent long-term survival, so it is crucial to study the~     effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be~     seen within the first 5 years after treatment, and that there is no dose threshold. This~     study aims to develop imaging and blood biomarkers of cardiac exposure, as a first step to~     identifying patients at increased risk for cardiac effects, so they can be targeted for~     close monitoring and early intervention, potentially with statins or ACE inhibitors.~     Additionally, by characterizing a time-course and radiation dose-volume relationship,~     potentially real-time modifications can be made to RT field design for patients sensitive to~     RT effects. Finally, this information can be incorporated into better designs of treatment~     plans for future patients.~   "
42841|NCT02496247|"~     This study will test the effectiveness of a weekly village distribution of canned herring~     for prevention of malnutrition in children aged 2-5 years old during a food-insecure time of~     the year in rural villages in Guinea-Bissau. The study will use community health workers to~     conduct the herring distribution, making this a test that will provide valuable information~     on what could become a practical food aid supplementation practice. The primary study~     hypothesis is that distribution of canned herring as a weekly food supplement to families~     with young children at the beginning of the rainy season will prevent a seasonal decrease in~     weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at~     baseline.~   "
42842|NCT02496234|"~     Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second~     most common cause of hospital acquired AKI. The development of CSA-AKI is independently~     associated with an increased risk of in-hospital death. There are currently no biomarkers~     that could identify patients at higher risk for AKI and current risk predictor scores that~     are based on clinical and demographic information are inadequate. Therefore, a diagnostic~     test for predicting AKI risk in this clinical context would assist clinicians to optimize~     surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient~     outcomes.~      The primary purpose of this study is to measure the association between baseline expression~     of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.~   "
42860|NCT02495987|"~     This study aims to understand the role of metabolic tissues in the changes of the metabolism~     of pregnant women and whether this contributes to some women developing metabolic diseases~     of pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy~     (ICP). Samples of adipose tissue will be taken when pregnant women are having caesarean~     section or laparoscopic procedures.~   "
42861|NCT02495974|"~     The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with~     metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as~     measured by time to treatment failure defined as the time from baseline (treatment~     initiation) to treatment discontinuation of enzalutamide for any reason including disease~     progression, skeletal related events, treatment toxicity, patient preference, or death.~   "
42843|NCT02496221|"~     Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and~     approved for the treatment of type 2 diabetes mellitus. The primary objective of this study~     is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder~     emptying. To make this assessment, each study participant will receive a dose of albiglutide~     and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement~     of the gallbladder.~      The study will be comprised of two periods and 20 subjects. The screening visit will occur~     within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated~     by a washout period of a minimum of 42 days. Subjects will return for a follow-up visit~     after 28 days following the last dose of albiglutide or placebo. The total duration of a~     subject's participation from Screening to Follow-up will be approximately 17.5 weeks.~      This study is a post marketing commitment to the United States Food and Drug Administration~     (USFDA).~   "
42844|NCT02496208|"~     This phase I trial studies the side effects and best doses of cabozantinib-s-malate and~     nivolumab with or without ipilimumab in treating patients with genitourinary (genital and~     urinary organ) tumors that have spread to other places in the body. Cabozantinib-s-malate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different~     ways by targeting certain cells. It is not yet known whether giving cabozantinib-s-malate~     and nivolumab alone or with ipilimumab works better in treating patients with genitourinary~     tumors.~   "
42845|NCT02496182|"~     The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an~     evolution to develop progressive interstitial fibrosis, who cause the death of the patient.~     Actually HP has been treated with Prednisone and occasionally with Azathioprine, but~     unfortunately the treatment with these drugs have not an effective result to treat the~     interstitial fibrosis.~      Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with~     positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and~     anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone~     to the actual treatment with Prednisone and Azathioprine in the treatment of patients with~     Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.~   "
42846|NCT02496169|"~     The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus~     Eluting stent system in patients with de novo coronary lesions.~   "
42847|NCT02496156|"~     This work is testing a shared medical decision making intervention for adolescents with type~     1 diabetes and their parents who are candidates for adding either an insulin pump or~     continuous glucose monitor to their treatment plan. The first half of the work consisted of~     the stakeholder driven design, construction and refinement of web-delivered multimedia~     decision aids for each of these decisions. The randomized controlled trial of that~     intervention began enroling participants in February 2015. A sample of 166 eligible~     adolescents who receive care at an operating entity of the Nemours Children's Health System~     will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the~     Shared Medical Decision Making intervention. Primary outcomes include measures of engagement~     with the pertinent technology if it is chosen and measures of decision quality; Secondary~     outcomes include indices of metabolic control, quality of life and parent-adolescent~     relationships around diabetes management.~   "
42848|NCT02496143|"~     The purpose of this study is to determine if EC-18 is safe and tolerable in healthy~     subjects.~   "
42849|NCT02496130|"~     The goal of this study is to compare common methods of tissue extraction at the time of~     minimally invasive surgery.~   "
42850|NCT02496117|"~     Study design: Investigator initiated, single centre, feasibility study~      Main objectives are twofold:~        1. To investigate the feasibility of RNS in patients with therapy resistant hypertension,~          which is assessing the functional distribution of renal nerves using 3D imaging and~          differential pacing modalities.~        2. To investigate the blood pressure responses and cardiac excitable properties to RNS,~          and subsequently perform a RDN procedure, guided by 3D mapping by two different~          techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.~      Study population: 40 patients (18 - 80 yr old)~   "
42851|NCT02496104|"~     Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age~     (GA)). The investigators called very preterm infants those who were born before 33 weeks of~     GA. These very preterm infants have a higher risk of developing neurological complications~     like developmental disabilities or cerebral palsy. To date, early assessment of these~     infants is difficult and not reliable enough to detect those who are at risks of developing~     neurological issues. Now, the investigators need to identify earlier these infants to~     provide them interventions to improve their development (physical therapy for example).~     Consequently, the investigators are examining a study whose aim is to assess preterm infants~     habituation. Habituation is the newborn ability to become familiar with new environmental~     stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even~     at onset of a noise or light. To study this phenomenon in infants born preterm near to~     corrected term (around 40 weeks of postnatal GA), will allow us to better understand~     neurological development of these infants. The investigators plan to compare habituation~     skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a~     population of infants born at term. The investigators will also study the link between~     habituation abilities and sleep quality as well as neurodevelopmental outcome at the~     corrected age of two years old.~   "
42852|NCT02496091|"~     The study is designed as a retrospective and multi-center study. The study population is US~     individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.~     The study includes retrospective data collection from the medical records and data~     collection from one prospective study visit with a clinical examination.The primary~     objective is to evaluate success. Success is defined as that the study implant and abutment~     are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent~     peri-implant tissues are reported during the study.~   "
42853|NCT02496078|"~     The purpose of this study is to determine whether a regimen consisting of daclatasvir and~     asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b~     infection.~   "
47604|NCT02433951|"~     In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients~     undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients~     only). Exercise tolerance is compared between groups.~   "
42862|NCT02495961|"~     The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing~     in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is~     attributable to genetic factors, clinical (waist circumference, adiposity and physical~     condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation)~     risk, each of which represents an independent risk.~      As has already studied and published in the investigators' group, the child population of~     Toluca has greater expression of cardiovascular risk factors than their counterparts in~     Bogota, Colombia. The metabolic characterization of the young population of Toluca and~     Bogota with new biomarkers such as homocysteine and leptin is an activity that aims to~     provide more metabolic data affecting young people.~      Hypothesis:~      After six months of follow-up there will be a greater relative risk in Mexican population to~     have identified another component of metabolic syndrome compared to the young population of~     Colombia.~   "
42863|NCT02495948|"~     The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses~     compared to ULTRA lenses after 30 days of wear.~   "
42864|NCT02495922|"~     Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in~     induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in~     lenalidomide maintenance treatment~   "
42865|NCT02495909|"~     Objective and Hypotheses: This project has the overall objective of implementing and~     evaluating new approaches to reducing the current and future burden of urinary~     schistosomiasis in young children using the antihelminthic drug Praziquantel. The project~     aims to (1) determine the operational health benefits of treating schistosome infections~     early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome~     structure (species diversity or abundance) is a risk factor for S. haematobium infection or~     morbidity, and (3) elucidate the factors and underlying mechanisms mediating the~     reduction/reversal of schistosome-related morbidity and resistance against~     infection/re-infection in young children.~   "
42866|NCT02495896|"~     This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA~     fusion protein when given together with standard chemotherapy regimens in treating patients~     with solid tumors that have spread to other places in the body and usually cannot be cured~     or controlled with treatment (advanced) or have spread to other places in the body~     (metastatic). Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein,~     paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride,~     docetaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet known whether standard chemotherapy regimens are more effective with recombinant~     ephB4-HSA fusion protein in treating advanced or metastatic solid tumors.~   "
42867|NCT02495883|"~     Essential Tremor (ET) is the most common tremor disorder, currently affecting an estimated~     2.9 million Americans and leading to disability and decreased quality of life in 75% of~     cases. The pathophysiology of ET is poorly understood, with the source of the tremor~     remaining controversial since all studies show increased activity in the cerebellum~     (including mimicked tremor in controls), while animal models of ET using harmaline and a~     single human PET study implicate the inferior olivary nucleus in the brainstem.~      There is evidence from the investigator's laboratory that the use of resting-state~     functional magnetic resonance imaging (rs-fMRI) is useful for characterizing the abnormal~     tremor neural network in ET compared with controls. The goal is to identify the source of~     the tremor, which is hypothesized to remain active during rest.~      Current ET diagnostic criteria require the presence of postural and/or kinetic tremor, which~     are assumed to be different manifestations of the same tremor oscillator. This long-standing~     assumption may be incorrect based on several lines of evidence from the investigator's~     laboratory, and has major implications for understanding ET pathophysiology and treatment.~     The investigators will test the hypothesis that postural and kinetic tremors are generated~     through different neural mechanisms.~      Treatment of ET focuses on pharmacological agents of various mechanisms and rarely deep~     brain stimulation of the Vim thalamus. Despite the assortment of agents used to treat ET,~     only ~50% of patients benefit from a particular agent. Furthermore, the mechanisms of action~     on tremor are not generally known. Understanding the mechanisms of action of various~     tremor-suppressing agents is critical for future drug development. In this proposal, the~     investigators plan to study the effects of ethanol (the most efficacious tremor-suppressant~     currently available) and propranolol (a non-specific β-adrenergic blocker with proven~     efficacy and unknown mechanism of action) on the tremor neural network.~   "
42868|NCT02495870|"~     Cooking meat at low temperatures for prolonged times is widely used among chefs and in food~     service due to the possibility to obtain a consistent and appealing eating quality. The~     method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat~     is vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for~     several hours. LTLT has several benefits - improved tenderness and juiciness, less cooking~     loss, better vitamin retention and uncompromised food safety.~      A recent PhD thesis concluded that one of the mechanisms behind the changes in eating~     quality during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The~     activity of proteolytic enzymes has shown to be dependent on heating temperature and time~     where the cathepsins were found to remain active during heat treatment. At 58°C the~     cathepsin B+L activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C,~     40°C and 70°C. A prolonged heating time of 17 hours at 58°C has also shown to increase~     cathepsin B+L activity. The proteolytic degradation results in the occurrence of peptides~     and amino acids such as tryptophan, tyrosine, leucine and histidine which could lead to a~     faster degree of satiety when consumed.~      According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited~     by protein ingestion could assist in the suppression of food intake and the onset of~     satiety.~      The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce~     a faster satiety response due to the higher availability of peptides and amino acids prior~     to digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the~     cook-chill method to mimic real life where meat is rapidly chilled after heat treatment,~     stored at 0-2°C and reheated and browned prior to serving.~   "
42869|NCT02495857|"~     The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical~     study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of~     Investigational hyaluronate as compared to placebo injected into the target knee for the~     treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the~     investigational product will also be compared with Euflexxa.~   "
42870|NCT02495844|"~     This study is to assess the efficacy, safety, and tolerability of the investigational drug~     UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in~     Europe.~   "
42871|NCT02495831|"~     To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of~     diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with~     respect to 50 mg diclofenac sodium administered alone.~   "
42872|NCT02495818|"~     The purpose of this study is to evaluate the effect of suprascapular nerve block guided by~     ultrasound combined with home exercises compared with placebo. Pain intensity, function,~     pressure pain threshold and goniometry were designed to be assessed in all patients.~   "
42873|NCT02495805|"~     The purpose of the study is to compare continuous femoral nerve block with continuous~     proximal adductor canal block for postoperative pain control and rehabilitation.~   "
42874|NCT02495792|"~     The purposes of this study are 1) to assess foot strike patterns initially, at six months~     and at one year between two groups of runners attempting to transition to a non-rearfoot~     strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to~     prospectively compare injury incidence rates at one year between NRFS and rearfoot strike~     (RFS) runners.~   "
42875|NCT02495779|"~     This study is designed to investigate the acceptability, perceived need and uptake of~     short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have~     sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based~     Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report~     occasional condomless sex and who anticipate a period of high-risk while away from home~     (e.g. vacation) during the study period.~   "
42876|NCT02495766|"~     This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal~     stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.~      Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6,~     the treatment will be crossed to receive the other product. The objective is to assess the~     safety of a single infusion BM-MSC, and to explore its efficacy in these patients.~      Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.~   "
42877|NCT02495753|"~     The purpose of this study is to test the hypothesis that vaginal cleansing with~     povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean~     infectious morbidity.~   "
42878|NCT02495740|"~     The effects of active commuting with an e-bike, as compared with a classic bike, on~     cardiorespiratory fitness and vascular health are largely unknown. To assess whether active~     commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in~     untrained and overweight individuals.~   "
42879|NCT02495727|"~     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength~     declining up to twice as fast as muscle size. This may eventually lead to loss of~     independence if tasks of daily living become too strenuous to be performed safely. Short~     periods of bed rest cause very rapid loss of muscle size and strength, and studies using~     healthy older participants have shown that age increases vulnerability to this muscle loss.~     However, it is unlikely that healthy individuals would be faced with periods of bed rest~     unless suffering a severe illness. In light of this, recent evidence has shown that even~     just reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg~     muscle in over 65 year olds. This amount of activity is roughly the equivalent of being~     housebound, something that may become more common into older age, for example due to~     prolonged bad weather, or minor injury or illness.~      This study will investigate what causes such stark muscle loss during two weeks of reduced~     activity, and the impact on skeletal muscle function and size, as well as balance, body~     composition, and other indicators of general health such as how the body responds to food or~     exercise. Importantly, exercise strategies that could reduce muscle loss during a period of~     reduced activity will also be investigated.~      In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of~     reduced physical activity by limiting their daily steps to <1,500/day. All groups will then~     undertake a re-training exercise programme to ensure that any losses in muscle strength or~     size are regained. One of the groups will be a control, whereby they will undertake the~     step-reduction intervention and re-training, but no protective exercise before or during the~     step-reduction intervention. This group will allow us to achieve our primary objective of~     determining the influence of two weeks of reduced physical activity on muscle strength and~     size in healthy older males. The two other groups will undertake either four weeks of~     strength exercise training before the step-reduction intervention, or daily home based~     exercise 'snacking' during the step-reduction intervention. The potential protective~     benefits of the exercise interventions in reducing the impact of two weeks of reduced~     activity on muscle strength and size, and any effect on how muscle is re-gained afterwards,~     will be compared to the 'control' group.~   "
42880|NCT02495714|"~     HOPP Learning will be implemented in elementary schools in the Horten municipality and will~     assess the effect of a combined pedagogical approach, active learning, on a large student~     population. Students are to increase their amount of physical activity with learning, during~     a school day by one hour.~   "
42881|NCT02495701|"~     Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to~     perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint~     pain and a skin burn after surgery (1). Moreover, it has been described that surgeons~     performing the procedure have a learning curve related to the number of complications~     described postoperatively. At the investigators' institution, hip arthroscopies have been~     performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past~     years, changes have been made to secure the best possible comfort for the patient during the~     arthroscopic procedure. Hence, there is a rationale for investigating complications after~     hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with~     the patient comfort in focus.~   "
42882|NCT02495688|"~     The purpose of this study is to compare general and regional anesthesia with regard to~     postoperative pain in patients who undergo surgery in a day surgery setting due to a~     displaced distal radius fracture.~   "
42883|NCT02495675|"~     This study evaluates the work of breathing among healthy subjects under various conditions~     of treatment with high flow nasal cannulas. Ten subjects will be included. The design of~     this study is a cross over of five treatment periods with different flow settings.~   "
42884|NCT02495662|"~     This study will investigate if liposomal prednisolone is effective in promoting~     arteriovenous fistula (AVF) maturation when administered to human subjects after surgical~     creation of a radio-cephalic AVF.~   "
42885|NCT02495649|"~     The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer~     for Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with~     Parkinson's disease.~      The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients~     with no synuclein underline pathology or previously known cardiovascular disease (no history~     of high blood pressure or take medications that influence the sympathetic system- exclusion~     criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with~     Parkinson's disease or other synuclein pathology.~      The expected normal ratio of Heart/liver uptake values will be determined from scans of~     patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the~     basal ganglia and no cardiovascular diseases.~   "
42886|NCT02495636|"~     The primary purpose of this study is to look at effects, good or bad, of combining two~     investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in~     combination with a third agent, poly-ICLC, which is another investigational drug that is~     believed to work together with CDX-1401. All investigational drugs, MPDL3280A and CDX-1401~     in conjunction with poly-ICLC, have been evaluated separately in prior studies; however,~     this is the first study assessing the combination therapy.~   "
42887|NCT02495623|"~     A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the~     Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production~     in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)~   "
42888|NCT02495610|"~     INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence~     of elevated intracranial pressure. Patients often present with the Hakim triad comprising~     gait disturbance, dementia and urinary incontinence. Treatment consists of~     ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the~     central nervous system (CNS); a generally safe and welltolerated procedure nevertheless~     invasive in nature and associated with surgical risk. The currently used diagnostic~     algorithms to predict surgery outcome by testing patients before and after a diagnostic~     spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and~     limited validity. Developing measures to accurately diagnose and select patients for~     intervention is thus of great importance. The objective of this study is to define and~     validate a diagnostic algorithm for the selection of patients with symptoms compatible with~     iNPH for shunt surgery.~   "
42889|NCT02495597|"~     The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the~     results of the Lung Clearance index (LCI) . Further this study evaluates bronchial~     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28~     years compared with an age- and sex-matched control group. The investigators will perform a~     pulmonary function test (body plethysmography with DLCO) and compare the results with the~     LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood~     sample to determine the level of systemic inflammation. Finally induced sputum is collected~     and a cell count is performed, and cells and supernatants are analyzed for inflammatory~     markers. This study will set baseline markers for future interventional studies.~   "
42890|NCT02495584|"~     Vitamin D insufficiency has become a global concern, with low vitamin D status associated~     with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and~     Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude,~     increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent~     survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status,~     with lower levels noted in the winter months. Variations in vitamin D status have been known~     to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet~     (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of~     vitamin D during the winter months, causing us to rely on dietary sources. The aim of this~     intervention is to investigate the main effects of vitamin D3-fortified milk and~     supplemental vitamin D3 on vitamin D status and functional health outcomes during the~     winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from~     UV exposure. Participants will be recruited from the local community. Blood samples will be~     collected from each participant at two timepoints (September/October and March/April). Pre-~     and post-intervention blood pressure, grip strength, height, weight, waist and hip~     circumferences will be measured, in addition participants will undergo a dual energy x-ray~     absorptiometry (DXA) scan to assess body composition and bone mineral density. Information~     on general health, lifestyle, physical activity, dietary intake and typical behaviours in~     the sun will be collected. Following the dietary intervention, a subset of participants will~     be invited to participate in a follow-up study, examining UV exposure during the summer~     months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and~     provide 2 additional blood samples.~   "
42891|NCT02495571|"~     This study aims to assess the presence and the intensity of voluntary and cough reflex in~     patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy~     control group. The assessment of the cough is fundamental to verify the mechanism of airways~     protection which is particularly compromised in ALS patients.~      Objective parameters of voluntary and reflex cough would be measured by the spirometer. The~     reflex of cough would be elicited by a solution of citric acid through an ultrasonic~     nebulizer.~   "
42892|NCT02495558|"~     The cough assessment is fundamental in the weaning process as it gives information on the~     possibility to expel food and secretion out from the airways. The majority of persons~     suffering from severe acquired brain injury are not able to cough voluntary due to severe~     cognitive deficit. In the present study, it would be evaluated the intensity of the reflex~     cough (RC) and the results would be correlated with weaning outcome.~   "
42893|NCT02495545|"~     The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and~     efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the~     combination of CSFD and elevation of mean arterial pressure (MAP) in patients with acute~     spinal cord injury (SCI). The objectives of the trial are to evaluate (i) efficacy of~     reducing intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary~     efficacy of combination of CSFD and elevation of MAP compared to elevation of MAP alone in~     improving neurologic motor outcomes in patients with acute SCI; and, (iii) safety of~     intensive CSFD in acute SCI patients.~   "
42894|NCT02495532|"~     Regional lymph node metastasis is a major determinant of local recurrence and overall~     survival rates in patients with colorectal cancer. Because of the poor prognosis associated~     with the presence of lymph node metastasis, stage III colorectal cancer patients should~     receive adjuvant treatment with chemo and / or radiation therapy according to the site of~     tumor. Several authors have investigated the use of revealing solutions for lymph node~     clearance in colorectal cancer. Most studies comparing conventional histopathological~     specimen examination to any lymph node clearing technique showed that the use of revealing~     solutions increases the mean number of lymph nodes harvested, usually in a statistically~     significant manner. It is still controversial the impact of the use of revealing solutions~     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.~     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF~     and Carnoy solutions for the histopathological examination of patients with colorectal~     cancer. The aim of this study is to determine the lymph node revealing solution with the~     best performance (increase in the mean number of lymph node harvested and lymph node~     upstaging) in patients with colorectal cancer.~   "
42895|NCT02495519|"~     Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm~     that typically arises in the abdomen but can develop at other anatomic sites, most commonly~     in the extremities. These tumors have a relatively high local failure rate after primary~     treatment using surgery and/or radiotherapy, and although rarely giving rise to distant~     metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may~     recur adjacent to the site of surgical resection, underscoring the limitations of surgery in~     the palliative setting. Therefore, effective medical therapies for AF are needed to maintain~     quality of life and prolong survival.The goal of the current study was to better define the~     activity of imatinib in the treatment of AF and to determine the molecular basis for~     response/nonresponse~   "
42941|NCT02493881|"~     The investigators hypothesized that, sometimes the posterior branch of the recurrent~     laryngeal nerve may also have motor function. The investigators aimed to evaluate motor~     function of the branches in the branching recurrent laryngeal nerves in this study.~   "
42896|NCT02495506|"~     This study will investigate the effects of Leukocyte reduced cold-stored platelet~     transfusions used in treatment of immediate postoperative blood loss in patients undergoing~     thoracic surgery in combination with extracorporal circulation. Today platelet concentrates~     are stored at 22 degrees C .~      This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aimn of study~     is to compare platelet function in bleeding patients transfused with leukoreduced platelet~     concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Patients with~     expected time on extracorporal circulation more than 120 minutes and/or medical platelet~     inhibitors will be included.~      Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography~     (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse~     events will be recorded.~   "
42897|NCT02495493|"~     Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan~     and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often~     burdened with higher toxicity and serious neutropenic infection. Therefore, future trials in~     neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve~     efficacy, but less toxicity.~   "
42898|NCT02495480|"~     A novel disposable sheathed gastroscope system has been shown to be safe and more efficient~     in clinical practice during gastroscopy. This novel disposable sheathed endoscope system~     could effectively prevent cross-infection by simply taking off the contaminated sheath after~     examination of a patient and placing a new sheath on the endoscope. In this way,~     investigators can save the endoscopic reprocessing time and also decrease the need for~     endoscopic cleaning and disinfecting equipment.~      Participants may think that placing a new sheath on the endoscope can decrease the success~     rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on~     the endoscope during scope insertion can probably increases distension of the colonic lumen~     and loop formation. The probable adhesion may increase the discomfort of investigators and~     participants. But a previous clinical study by investigators' team showed that the~     participants' feeling were no significant difference (Z = -1.783, P = 0.075) between~     sheathed and conventional groups. No significant differences were observed in optical~     clarity, or pathology detection rate. There were no complications, and no microbial~     contamination was detected. Based on this study, investigators hypothesize that compared~     with conventional group, placing a new sheath on the endoscope does not significantly reduce~     the success rate of cecal intubation in average patients.~      The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the~     endoscope versus the conventional method in average participants. The primary outcome is~     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum~     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection~     rate.~   "
42899|NCT02495467|"~     This study is designed to evaluate the efficacy and safety of MED2005, a topically applied~     glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with~     erectile dysfunction (ED) immediately before sexual intercourse.~   "
42900|NCT02495454|"~     GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell~     non-Hodgkin's lymphoma.~   "
42901|NCT02495441|"~     The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the~     predicate device Amnisure® in detecting pre labor rupture of membranes. 4 test kits are~     compared against a common referent standard (gold standard), which is clinical assessment.~   "
42902|NCT02495428|"~     The aim of this study was to determine the effect of Kinesio taping on lactic acid in an~     running anaerobic test.~   "
42903|NCT02495415|"~     This study addresses the hypothesis that intermittent treatment with fenretinide intravenous~     emulsion will induce objective responses in patients with relapsed or refractory Peripheral~     T-cell Lymphoma (PTCL) who have failed at least two prior systemic therapy and will result~     in acceptable toxicities.~   "
42904|NCT02495402|"~     To test the effectiveness of a single 20-30 minute motivational interviewing-based brief~     intervention for substance use within HIV/AIDS settings.~   "
42905|NCT02495389|"~     This study is for women diagnosed with urgency incontinence or overactive bladder (OAB).~     Some patients continue to have symptoms even while taking medication for OAB. The purpose of~     this study is to see if women who respond to a medication called mirabegron have different~     bladder bacteria than women who do not respond.~   "
42906|NCT02495376|"~     We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes~     of health related quality of life, disease symptoms, and biological correlates of stress in~     a sample of young adults with cancer. The proposed work will serve as an essential~     foundation for launching a program of clinical stress reduction research with this~     traditionally underserved population and has the potential to lead to the discovery of~     specific, modifiable psychosocial, behavioral, and biological mechanisms from which to~     address the problem of health disparities with this group.~   "
42907|NCT02495363|"~     Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid~     consumption after surgical removal of breast tissue.~      This study's uniqueness is in the quantification of the analgesic effect of regional~     anesthesia on its influence to reduce the use of opioid substances, and the variety of side~     effects associated with them, which has yet to been described in literature.~   "
42908|NCT02495350|"~     In this study the investigators would like to evaluate how prelabor analgesic plan and~     actual labor analgesia effects the labor satisfaction, breastfeeding success, and whether or~     not it reduces postpartum depression.~      Although postpartum depression has been researched and reviewed, there is little information~     on how satisfaction during labor affects postpartum outcomes. The relationship between~     epidural analgesia is also complex, and there has yet to be found a valid correlation~     between the two parameters.~      In addition although an attempt has been made to evaluate relationship between breastfeeding~     and epidural analgesia, results are unclear and further research is needed.~   "
42942|NCT02493868|"~     The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral~     antidepressant compared with an oral antidepressant (active comparator) plus intranasal~     placebo in delaying relapse of depressive symptoms in participants with treatment-resistant~     depression (TRD) who are in stable remission after an induction and optimization course of~     intranasal esketamine plus an oral antidepressant.~   "
42909|NCT02495337|"~     This proposed collection of primary tumor cells lines will benefit esophageal cancer~     research within the University Health Network. This collection of gastro-esophageal tumor~     samples will be used to grow primary tumor cell lines, which will provide researchers with~     ready samples of various gastro-esophageal cancers. This will help to address the issue of~     access to these cell lines due to the limited number of patients with gastro-esophageal~     tumors, and high rates of contamination.~      Samples will be collected during surgery or Esophagogastroduodenoscopy(EGD). The surgeon~     will resect a sample for the research coordinator and/or fellow who will collect the sample~     and take it back to the lab for processing. Samples collected will be in excess of standard~     samples that are sent for pathology. The surgeon will make sure that excess samples will not~     affect pathological diagnosis~   "
42910|NCT02495324|"~     The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to~     Valsartan and Olmesartan(reference group) in patients with mild to moderate essential~     hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking~     required dose and 4 weeks of taking double dose.~   "
42911|NCT02495311|"~     The aim of this study is to assess the relationship between adenomyosis/myoma and lower~     urinary tract symptoms, sexual function and gastrointestinal symptoms.~   "
42912|NCT02495298|"~     The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction,~     functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS).~     Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston~     Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.~      The study is blind for the patient and the raters.~   "
42913|NCT02495285|"~     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.~     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital~     functions. So far, there is only few data on the safety and efficacy of the products under~     investigation in children.~      The primary aim of this non-interventional observational study (NIS) is to collect further~     data of gelatine solutions in a large pediatric population during routine clinical practice.~   "
42914|NCT02495272|"~     The investigators are planning to determine the effect of the timing of oxytocin~     administration on the amount of blood loss, necessity for additional medical or surgical~     interventions.~   "
42915|NCT02495259|"~     The purpose of this study is to compare three different standard of care methods of~     double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have~     thoracic surgery in which lung isolation is required.~   "
42916|NCT02495246|"~     This is a clinical trial in which healthy volunteers will be administered two experimental~     Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated~     with both vaccines one after the other in a prime/boost regimen.~      All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.~      Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28~     days later.~      Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28~     days later.~      Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56~     days later.~      Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56~     days later.~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made~     from viruses which are modified so that they cannot multiply. The viruses have extra DNA in~     them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so~     that the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Oxford and London, England. The study will be~     co-funded by GSK Biologicals and Crucell Holland BV.~   "
42917|NCT02495233|"~     The purpose of the Phase 1b part of the study is to evaluate the safety and tolerability of~     ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of~     ASP2215. The purpose of the Phase 2 part of the study is to evaluate the objective response~     rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.~   "
42918|NCT02495220|"~     The purpose of the present study was to evaluate the efficacy and safety of subtenon block~     (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous~     dexmedetomidine for postoperative analgesia and emesis control in infants undergoing~     cataract surgery.~   "
42919|NCT02495207|"~     Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock~     Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the~     removal of impacted mandibular third molars on both sides of the jaw.~   "
42920|NCT02495194|"~     The objective of this study is to determine whether horticultural therapy would improve the~     psychological well-being of the older adults. 70 healthy elderly were randomized into the~     active horticultural therapy or the waitlist control group. Sessions will be conducted~     weekly for 12 weeks, and monthly for 3 months. Participants would be assessed at 3~     time-points: at the start, at 3-months and at 6-months.~      It was hypothesized that as compared to the waitlist control group, participants in the~     active horticultural therapy will have (1) lower depression and anxiety symptomatology; (2)~     higher life satisfaction; (3) feel more socially connected; and (4) improved cognitive~     functioning.~   "
42921|NCT02495181|"~     The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept~     monotherapy with the efficacy and safety of combined treatment with Aflibercept plus~     standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration~     (AMD) patients with polypoidal choroidal vasculopathy (PCV).~   "
42922|NCT02495168|"~     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week~     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide~     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation~     aerosol.~   "
42923|NCT02495155|"~     In order to determine the acceptability of a breast cancer-specific cognitive behavioral~     therapy intervention, as well as to obtain preliminary data to assess efficacy in managing~     symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia,~     fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and~     to complete patient-reported outcomes assessments before and after the 8 week intervention.~   "
42924|NCT02495142|"~     Bariatric surgery is associated with long-term weight loss, as well as short-term~     improvements in obesity-related medical comorbidities. However, a significant proportion of~     patients fail to lose sufficient weight, or experience significant weight regain. Although~     no robust predictors of response have been identified, pilot data that will be presented and~     reviewed suggest that surgery has profound effects on eating behaviors and psychosocial~     functioning, and that these factors may affect postoperative weight control.~      The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery~     (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery~     among a geographically, ethnically, and racially diverse sample of men and women undergoing~     bariatric surgery. This project unites experts in the areas of psychopathology, eating~     behaviors and quality of life to conduct a naturalistic study using state-of-the-art~     assessment tools; to document the relationships among psychosocial factors; and to examine~     psychosocial predictors of surgical outcomes.~   "
42925|NCT02495129|"~     This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS)~     patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if~     the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary~     glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part~     3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on~     Part 3.~      The overarching purpose of this study is to test a new drug (VAY736) for the treatment of~     pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are~     affected by inflammation. A certain type of white blood cells called B cells prominently~     infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary~     glands. Scientific evidence suggests that B cells may be involved in the disease process in~     pSS and that eliminating B cells may benefit patients with pSS. This study will test a new~     imaging method and a new treatment for pSS. Both the imaging method and the treatment are~     specific for B cells.~   "
42926|NCT02494076|"~     Asthma is a leading cause of emergency department (ED) visits for children. A novel way of~     treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory~     pressure works by creating pressure in the lungs to keep airways open and to clear mucus~     from the lungs. PEP is already used in the treatment of asthma at the investigators~     institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do~     not exist. This study plans to learn more about the use of PEP therapy in the treatment of~     asthma exacerbations in children in the emergency department. Specifically, the study aims~     to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if~     it reduces the need for additional therapies and admission to the hospital. This study will~     be a randomized control trial comparing children who receive standard therapy to those who~     receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children~     age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be~     included in the study. Reduction in clinical asthma severity will be measured by change in~     the Pulmonary Asthma Score (the respiratory severity score used at the investigators~     institution). The need for additional therapies and hospitalization will also be evaluated.~   "
42927|NCT02494063|"~     To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is~     non-inferior to treatment with systematic pelvic lymphadenectomy.~      The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the~     reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after~     systematic pelvic lymphadenectomy, but that the less radical surgery is associated with~     significantly lower postoperative morbidity.~   "
42928|NCT02494050|"~     Anhedonia, characterized as (a) the diminished motivation to participate in activities,~     and/or (b) diminished enjoyment of a pleasurable activity are common symptoms among women~     diagnosed with mood disorders. This trial aims to test three treatments adapted to reduce~     anhedonia.~      The investigators will compare three treatment groups, specifically, two doses of Behavioral~     Activation treatment for anhedonia (i.e., 12 weeks vs. 8 weeks of BA) with an active~     comparator treatment, Bipolar Disorder Collaborative Care (12 weeks of BDCC). BA is a~     psychotherapy approach that helps participants to identify and modify environmental sources~     of their depression. BDCC is a supportive care approach that educates participants to~     optimize their medication initiation or their existing medication regimen. The time frame~     for this study will be between 12-14 weeks. Specifically, participants will be evaluated and~     enrolled within one week, then received up to 12 weeks of treatment (tracked through this~     time) and then complete two evaluations (one at week 8) and another at the end of treatment~     (an expected average of 12-14 weeks after enrolling into treatment).~      Primary analyses aim to compare the dose-mechanism change in BA relative to a standard~     medication optimizing protocol, BDCC. The secondary analyses are to evaluate individual~     differences in stated patient preferences for treatment, and group differences in treatment~     effect on anhedonia, side effects, and quality of life.~   "
42929|NCT02494037|"~     This study describes the three-year survival outcome of consecutively recruited advanced~     stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced~     integrative oncology (AIO) treatment at one of the participating North American advanced~     integrative oncology specialist clinics. This study also aims to describe AIO treatments~     recommended by naturopathic oncologists for these advanced stage cancer patients and pilot~     the collection and evaluation of health-related quality of life data on a subset of Canadian~     AIO-treated patients.~   "
42930|NCT02494024|"~     This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within~     the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with~     progressive supranuclear palsy (PSP).~   "
42963|NCT02494843|"~     The purpose of this study is to characterise, in detail, the cardiac structure, function and~     perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to~     ascertain if haemodiafiltration provides relative myocardial protection compared to~     conventional haemodialysis.~   "
42964|NCT02494830|"~     This study is designed for descriptive pharmacokinetic characterization of ketamine and~     norketamine in serum, urine and feces after oral single dose administration of a new~     developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine~     under fasting conditions and for descriptive pharmacokinetic characterization of ketamine~     and norketamine in serum, urine and feces after intravenous single dose administration of 5~     mg ketamine solution for infusion within 30 min~   "
42931|NCT02494011|"~     This study compared the effects of closed kinetic chain exercise and Russian current~     stimulation on pain, functional disability, wrist range of motion (ROM) and grip strength in~     patients with colles' fracture. Forty five patients with stable colles' fractures are~     randomly classified into three groups with fifteen patients in each group; Group I received~     traditional exercise in the form of; Mobilization, stretching exercises, range of motion~     exercises (passive and active) and edema control of the wrist joint. Group II stimulated by~     electrical Russian current in addition to traditional exercise. Group III received closed~     kinetic chain exercise (wall press, plyometric wall push up, Quadruped rhythmic~     stabilization, and Push up exercises) plus traditional exercise. All outcome measures~     including Pain, function, Wrist ROM, and grip strength were evaluated before and after the~     treatment program.~   "
42932|NCT02493998|"~     Mucopolysaccharidosis type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B) is a~     severe neurodegenerative disorder. The purpose of this study is to learn more about the~     health problems in patients with MPS IIIB and how to measure these problems over time. It~     will particularly look at how the disease develops in young children. This is an~     observational study, so no experimental drug will be given. The results from this study will~     help us design future studies to measure whether these health problems get better when we~     give experimental drug for MPS IIIB.~   "
42933|NCT02493985|"~     The purpose of this study is to study the effects of carbon dioxide combined with head down~     tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based~     analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor~     brain physiology.~   "
42934|NCT02493972|"~     This is a Multicenter prospective diagnostic study.~   "
42935|NCT02493959|"~     Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon~     food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study~     we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a~     C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.~   "
42936|NCT02493946|"~     The purpose of the protocol is to demonstrate the safety and the efficacy of a single~     injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex~     (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines~     between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after~     repeated injections.~   "
42937|NCT02493933|"~     To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine~     as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in~     patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly~     divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received~     CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80]~     received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80]~     patients received CC 100 mg/d plus NAC 1200 mg/day.~   "
42938|NCT02493920|"~     Lung protection should start in the delivery room where, from the first breaths, the preterm~     infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish~     the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in~     the delivery room has been demonstrated to lead to clearance of lung fluid and achievement~     of a precocious functional residual capacity (FRC) both in animal and human studies. SLI~     associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of~     the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome~     (RDS) and reduce need of mechanical ventilation (MV).~      Further studies are required to evaluate the clinical utility of this maneuver. The ability~     to monitor what happens to the lungs while applying different recruitment maneuvers in~     preterm infants would allow the definition of a procedure that allows optimal assistance to~     improve the FRC. One promising approach is provided by the forced oscillation technique~     (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied~     to the airway opening and the mechanical response of the respiratory system is studied by~     means of the total respiratory input impedance (Zin). Zin is a complex number that can be~     expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs).~     Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to~     changes in the mechanics of lung periphery and provides accurate information about lung~     volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the~     assessment of lung function in newborns submitted to SLI at birth. The investigators~     hypothesized that the application in the delivery room of the SLI in the preterm infant is~     effective in achieving a greater FRC and therefore a greater value of Xrs compared to a~     control group not treated with the SLI.~   "
42939|NCT02493907|"~     Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with~     severe systolic heart failure (HF) and ventricular desynchronization. Despite the~     consistently observed structural and functional improvements as well as reductions in HF~     events and mortality in large multicenter randomized trials, 30% patients remain classified~     as nonresponders. Present evidences showed that QRS duration was the most effective~     parameter to predict responsivity of CRT in patients with severe HF. But some studies showed~     that QRS duration could be influenced by obesity and gender. Accordingly, the simple QRS~     interval width of body surface electrocardiograph should not be the most satisfactory~     parameter for screening patients suitable for CRT. Recent study showed that left ventricular~     electrical delay, as measured by the time from the onset of QRS to the LV electrogram peak~     (QLV), predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO)~     can increase the likelihood of structural response to CRT. However, it is unclear whether it~     is suitable for Chinese patients. The investigators would like to validate this relation in~     a Chinese population and explore if a corrected QLV might do better to predict the~     responsivity of CRT.~   "
42940|NCT02493894|"~     Now a days, due to the change in lifestyle, the extended lifespan and the increase in the~     rate of the road accidents, the need for surgical operation of spinal instrumentation has~     been increased. And these surgeries are the most crucial part of neurological surgery wards.~     The everyday improvements in the quality of equipment used and advancements in surgical~     methods lead to best performance of these procedures and finally the higher quality of~     patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to~     pain relief and better performance and developments in the quality of patients' lives.~      In addition to the above mentioned improvements, you must consider the fact that these~     activities are still accompanied by complications during and after surgical operation.~      Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate~     sagittal balance are the most significant side effects during spinal surgery.~      One of the most important complications during and after these surgeries is perioperative~     bleeding that causes problems both for the patients and the surgeon.~   "
42943|NCT02495103|"~     Background:~      - There are no established treatments for people with certain advanced kidney cancers. These~     tumors often don t respond well to currently available treatments. Researchers believe that~     two drugs that treat other diseases metformin and vandetanib could help people with advanced~     kidney cancer.~      Objective:~      - To test the combination of metformin and vandetanib in people with advanced kidney cancer.~     Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose~     in people with certain kidney cancers.~      Eligibility:~        -  For Phase I, people 18 and over with advanced kidney cancer~        -  For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell~          cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced~          papillary renal cell carcinoma not related to a hereditary syndrome~      Design:~        -  The study will last many months.~        -  Participants will be screened with medical history and physical exam.~        -  Participants will take the study drugs by mouth every day.~        -  Participants will measure and record their blood pressure every day.~        -  Participants will have many tests:~        -  Blood and urine tests~        -  MRI, CT, PET scan, and other imaging tests: they will lie in machines that take~          pictures of their body.~        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s~          signals.~        -  Bone scan~        -  Some participants may have a gynecology evaluation or photos of skin tumors taken.~        -  Participants will have an optional tumor biopsy.~        -  After they stop taking the drugs, participants may have medical history, physical exam,~          and blood tests. They will be contacted once a year by phone to find out how they are~          doing.~   "
42944|NCT02495090|"~     Hypospadias is the second most common malformation of the male genitalia and consists in a~     congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of~     the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus~     position may be located anywhere along the penile shaft, but more severe forms of~     hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and~     penile anterior represents approximately 70% of all the diagnosed cases.~      The frequency of family reached depend on the severity of hypospadias. The number of~     children which have hypospadias mutation discovered by classical technique is low. Families~     are often the cause of the discovery of new genes involved in sexual differentiation because~     they allow comparison of genomes of related persons, and detect more easily mutations.~   "
42945|NCT02495077|"~     During transplant surgery, there is a period of time when a donated kidney is removed from a~     donor's body and stored until the time of the transplant surgery. The storage procedure~     results in buildup of various proteins within the kidney that can injure the donated kidney~     after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).~      The purpose of this study is to evaluate whether taking infliximab, which blocks TNF-alpha,~     just prior to transplant surgery along with usual transplant medicines will protect the~     donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy~     for a longer period of time.~   "
42946|NCT02495064|"~     Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of~     head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the~     benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a~     previous study.~   "
42947|NCT02495051|"~     The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but~     BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly~     affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal~     reflux disease. Because gastroesophageal reflux disease plays a major role in the~     development of BE by causing repeated mucosal damage, development of BE is a concern even in~     children and young adults in this specific population. The aim of this study is to assess~     the prevalence of BE (gastric and/or intestinal metaplasia) in a population of~     adolescents/young adults who had been treated for EA in early infancy. All eligible patients~     received upper gastrointestinal endoscopy under general anesthesia with standardized~     esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.~   "
42948|NCT02495038|"~     BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The~     investigators studied whether the prediction is possible to have a sufficient effect of~     reducing the dose when combining the two neuromuscular blocking agents through monitoring~     neuromuscular relaxation during surgery.~      METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose~     (ED)95 rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27)~     reduced 10% of each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each~     ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were~     prepared by a nurse who was not involved in this study. Each study drug was administrated to~     the patient and timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the~     ulnar nerve was used as setting of 2 Hz per 12 sec. The investigators checked time to TOF~     ratio=0 (Onset), time to 1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index)~     under total i.v. anesthesia (TIVA). One way ANOVA was used for statistical analysis (α=0.05,~     β=0.2).~   "
42949|NCT02495025|"~     The purpose of this research study is to test the effectiveness of telephone-based early~     childhood developmental screening and care coordination, compared to usual care in a primary~     care pediatrics clinic. We will randomize approximately 150 participants to each study arm,~     with the intervention families receiving developmental screening over the phone, and control~     families receiving usual care with their pediatricians.~   "
42950|NCT02495012|"~     A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet~     thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI)~     before receiving PCI therapy, in order to provide evidence for Phase III design.~   "
42951|NCT02494999|"~     In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine~     produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind,~     parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged~     3-6 months in China.~   "
42952|NCT02494986|"~     The purpose of this study is to provide continued access to rilpivirine (RPV) for~     participants who were treated with RPV in a clinical development pediatric study with~     rilpivirine and who, at the time of roll-over, experience and are expected to continue~     experiencing clinical benefit from RPV treatment.~   "
42953|NCT02494973|"~     Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is~     opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the~     potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR,~     after resection of CRLM have been reported.~      The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to~     initiate protocol-directed therapy and completed median of six cycles (range, one to six).~     Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable~     patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients~     have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7~     months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met~     the prespecified end point of higher than 85% survival at 2 years and were clinically~     tolerable.~   "
42954|NCT02494960|"~     Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as~     they require motivated smokers to visit the clinic or make a phone call to seek help.~     However, in most middle-resource countries, smoking cessation clinics are not well~     publicized. Most health care professionals (HCP) are not active in performing smoking~     cessation counselling to their patients. They are not aware of the available smoking~     cessation services or the benefits of such services and hence do not refer smokers to~     smoking cessation services. On the other hand, physicians play a critical role in reducing~     tobacco use by advising smoking patients to quit (Richmond, 1999). Physician's advice to~     quit smoking not only motivates smokers to quit but also increases their quitting confidence~     (Fiore et al., 2000; Ossip-Klein et al., 2000).~      Brief smoking cessation interventions have been shown to be effective with strong evidence~     from randomized controlled trials (RCTs), however, it is no evidence to show that longer~     interventions are more effective than shorter interventions. If carried out in routine~     clinical practice by all physicians and other HCP, brief interventions can potentially~     benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose~     to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds~     AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong~     province, China~      This project aims to evaluate the effect of physicians' brief smoking cessation intervention~     (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.~   "
42955|NCT02494947|"~     The primary purpose of this study is to investigate if systematic, high intensity,~     interval-based aerobic exercise training results in regression of lipid content of~     atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with~     stable coronary heart disease. Composition and morphologic characteristics of plaques will~     be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound~     (IVUS) in patients undergoing percutaneous coronary intervention.~   "
42956|NCT02494934|"~     The purpose of the study was to compare the effectiveness of cognitive behavioural therapy~     (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked~     vestibulodynia (PVD).~   "
42957|NCT02494921|"~     This is a Phase Ib/II open label clinical trial in patients with metastatic castration~     resistant prostate cancer. The objective of the phase Ib portion of the study is to~     establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel~     (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in~     escalating oral daily doses in patients with metastatic CRPC with prior resistance to~     abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic~     disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this~     combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing~     schedule is being chosen to allow patients to be exposed to the most efficacious dosing~     schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with~     the treatment combination at the first dose level (dose level I), an alternative dosing~     schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has~     demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week~     dosing schedule.~      The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of~     ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the~     efficacy and further define the safety of the treatment combination. Patients will be~     treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles.~     If there is no evidence of radiographic or clinical disease progression after 9 cycles of~     protocol therapy, patients may continue on single agent maintenance ribociclib until the~     time of disease progression. Patients will have the option of starting maintenance~     ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The~     dose of ribociclib used during maintenance will be the same dose as that immediately~     preceding cessation of docetaxel treatment.~   "
42958|NCT02494908|"~     As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle~     changes in brain tissue even after a very short timescale of hours resulting from performing~     a cognitive task and learning, We wish to explore and compare those changes to patients with~     idiopathic PD (IPD) and see if there are changes in the learning process and can we detect~     them using widely available noninvasive techniques such as MRI.~   "
42959|NCT02494895|"~     To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor~     vs. ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.~   "
42960|NCT02494882|"~     The purpose of this study is to test the safety of a new combination of three oral drugs in~     Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have~     been studied before in humans.~      This is a phase I study in which ruxolitinib dose will start low for the first patient~     together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect,~     the ruxolitinib dose will slowly be made higher as new patients take part in the study. This~     will help the investigators find the right dose of ruxolitinib to give together with~     dexamethasone and dasatinib that will be used in future studies~   "
42961|NCT02494869|"~     This study is being done to look at the effect that different amounts of progressive~     exercise training has on risk factors associated with developing breast cancer. These risk~     factors include exercise capacity, body weight, and body composition, as well as the~     expression of certain genes and levels of inflammatory factors in your breast tissue.~   "
42962|NCT02494856|"~     The present clinical trial randomized compared the clinical efficacy of the naproxen~     associated or not with esomeprazol, for the removal of lower third molars. Onset, duration~     of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative~     bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th~     postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal~     of symmetrically positioned lower third molars, in two separate appointments (one to two~     months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a~     doubleblind, randomized and crossed manner.~   "
47605|NCT02433938|"~     Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the~     enhancement of the recovery of bowel function and in shortening the hospital stay.~   "
42965|NCT02494817|"~     Though technology is integrated into the lives of our target population, use of any~     particular technology will depend on the content delivered, aesthetic appeal, and overall~     design. Based on the completion and analysis of data from Phase 1, the investigators were~     able to obtain feedback on HIV-negative male couples' attitudes toward the original content~     in the prevention toolkit modules. The research team, along with the web-developers, used~     this feedback to specifically tailor the content of the modules to fit the unique needs of~     the intervention's target population: at risk HIV-negative male couples. For Phase 2, the~     investigators conducted focus groups at each site to help identify strengths and potential~     areas for improvement of the prevention toolkit, which will be incorporated before piloting~     it in the intervention for Phase 3 of this project. After assessing the acceptability of the~     prevention toolkit, including the content of modules, aesthetic appeal, and overall design~     with HIV-negative male couples target population, the research team will pilot test whether~     the RCT with the prevention toolkit will help reduce HIV risk through formation and~     adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual~     sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The~     interactive website, herein referred to as the HIV prevention toolkit will contain unique~     modules about sexual agreements and effective HIV prevention strategies.~   "
42966|NCT02494804|"~     The purpose of this study is to determine whether combining of Temozolomide and~     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant~     Glioma is also evaluated.~   "
42967|NCT02494791|"~     This study will maximize identification of women with Lynch Syndrome using an enhanced~     screening strategy to identify those at risk. These women will be referred to genetic~     counselling for testing and those found to have Lynch Syndrome will be asked to invite first~     degree relatives to participate and undergo genetic testing for Lynch Syndrome. Screening~     guidelines and risk reducing surgery options for participants found to have Lynch Syndrome~     will be reinforced by the study and adherence to these guidelines will be assessed annually~     for ten years following Lynch Syndrome diagnosis to assess the impact and cost-effectiveness~     of this enhanced screening approach.~   "
42968|NCT02494778|"~     The purpose of the study is to collect and assess long term data on the safety,~     tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).~   "
42969|NCT02494765|"~     At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric~     and neonatal patients. The investigating hospital is one of the pioneers in providing this~     service in the Kingdom (which was established about 10 years ago) to the patients of this~     age group. Only a small percentage of pediatric patients with age above 8 years accept the~     procedure to be done without anesthesia; and majority of MRI procedures are done under~     general anesthesia. The airway management of these patients is commonly accomplished with~     laryngeal mask airways (LMA).~      LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients~     (including ex-premature) have also been benefited by the use of LMA. There are many~     advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion,~     securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat,~     post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and~     intra ocular pressure (IOP) stability.~      There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA~     classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other~     (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI~     compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel~     LMA and in King Khalid University Hospital (the investigating hospital) these two types are~     being used.~      On search of literature the investigators found only one study in adults in which such~     comparison has been made and there was no study comparing different LMAs on the basis of~     their spatial effects on anatomical structures of the neck and airway in pediatric patients~     with age 12 years or below.~      In this prospective randomized study, the investigators will compare the spatial~     relationship of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in~     pediatric patients undergoing 3-D MRI under general anesthesia (GA).~   "
42970|NCT02494752|"~     Contour deformity of face causes both functional as well as aesthetic problems for the~     patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler~     because it is abundant, readily available, inexpensive, host compatible, and can be~     harvested easily and repeatedly. However absorption of grafted fat is a major problem~     resulting in lack of consistency of final clinical outcome. Adipose tissue derived~     mesenchymal stem cells have the potential to enhance the viability of the grafted fat and~     the reliability of the final outcome of surgery. In the current study potential of~     mesenchymal stem cells will be studied by comparing two groups of patients requiring fat~     grafting for contour deformities of face. Control group will have fat graft with out~     enrichment with stem cells whereas experimental group will have their fat graft enriched~     with mesenchymal stem cells. Comparison will be made regarding viability of grafted fat in~     two groups.~   "
42971|NCT02494739|"~     The purpose of this study is to investigate the possible antioxidant and anti-inflammatory~     effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.~   "
42972|NCT02494726|"~     The overall purpose of this study is to evaluate how effective Thromboelastography (TEG) is~     on identifying ischemic and hemorrhagic stroke patients at increased risk for bleeding after~     receiving tissue plasminogen activator (tPA), as well as on differentiating between patients~     in whom optimal thrombolysis has been achieved, and those whom it has not.~   "
42973|NCT02494713|"~     This is a study for men who have locally-advanced prostate cancer and are eligible to~     undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that~     cancer may spread to other organs in the future, even after the prostate is removed. If this~     were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone~     therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that~     neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The~     purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy~     given before prostate removal.~   "
42974|NCT02494700|"~     The goal of this clinical research study is to learn about the effectiveness of low dose~     radiation therapy in patients with low grade B cell lymphoma or mantle cell lymphoma~     involving the eye.~   "
42975|NCT02494687|"~     Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or~     absent. The gastroparesis prevents normal digestion from occurring. The purpose of this~     study is to provide oral Domperidone offered under the U.S. Food and Drug Administration~     (FDA) expanded access program, to patients that, based on the treating doctor's assessment,~     could benefit from , a prokinetic effect for the relief of refractory gastroesophageal~     reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic~     constipation.~   "
42976|NCT02494674|"~     This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn~     device to track calorie intake and promote weight loss. A podcast is a digital audio file~     that can be listened to on portable media players, like iPods, and personal computers. This~     study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight~     loss information delivered via twice weekly podcasts. You will also track each meal you eat~     by wearing a provided watch-like device.~   "
42977|NCT02494661|"~     The purpose of this study is to access the acceptability and potential utility of~     nutritional intervention videos in 1) changing knowledge and attitudes about healthy eating,~     2) improving healthy food shopping practices, and 3) enhancing skills for stress reduction~     during food shopping among low-income Latina mothers.~   "
42978|NCT02494648|"~     Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The~     prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have~     shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality~     (RR = 9.1 [95%, 2.6 to 31.2]).~      If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD~     patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥~     20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI>~     30) may be too demanding. Alternative treatments are rare and results are highly variable.~     Therefore, it would be interesting to suggest other treatment modalities with moderate~     coronary and/or minimally symptomatic OSA syndrome.~   "
42979|NCT02494635|"~     This research trial studies two types of tests, an ultrasound test and a biomarker test, to~     see how well they predict how aggressive (invasive) bladder cancer is in samples from~     patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade~     the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a~     microscope to see how they respond. This may allow doctors to predict how likely the cancer~     cells are to spread in the body. The biomarker test uses laboratory testing of samples from~     patients to study genes and other molecules that may predict the cancer invasiveness.~     Comparing two different ways of predicting cancer aggressiveness may help doctors identify~     how well they work, and may eventually allow doctors to predict aggressiveness without~     needing to take a biopsy.~   "
42980|NCT02494622|"~     Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of~     these cases differ from those of small schwannomas. The aim of this study was to review the~     diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of~     patients who underwent surgery.~   "
42981|NCT02494609|"~     A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin~     (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy~     Premenopausal Women.~   "
42982|NCT02494596|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination~     of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors~     that have progressed during or after standard therapy, or for which no standard therapy is~     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs)~     in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).~   "
42983|NCT02494583|"~     This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with~     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants will be~     randomly assigned to one of the 3 treatment arms of the study: pembrolizumab as monotherapy,~     or pembrolizumab + cisplatin + 5-fluorouracil (5-FU) or capecitabine, or placebo + cisplatin~     + 5-FU or capecitabine. The primary hypothesis is that pembrolizumab provides a clinically~     meaningful progression free and/or overall survival.~   "
42984|NCT02494570|"~     A phase 2 multi-center investigation of efficacy of ABI-009 (nab-rapamycin) in patients with~     advanced malignant perivascular epithelioid cell tumor (PEComa)~   "
42985|NCT02494557|"~     Diabetic type 2 patients (DB2) has a higher prevalence of coronary artery disease (CAD) than~     non-diabetic persons. Presence of CAD results in murmurs arising from the filling of the~     arteries and can be detected by the CADScor System and can together with biological patient~     profile indicate the risk of presence of CAD in the patient. In the pilot study 100~     asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with~     computed tomography (CT) cardiography and single-photon emission computed tomography (SPECT)~     for assessing if combination of patient profile (gender, age etc) combined with above~     measures may give rise to new improved risk scoring method for he DB2-patient.~   "
42986|NCT02494544|"~     Patients will be randomized to either ConforMIS iTotal Knee Replacement or Off the Shelf~     knee replacement.~      The patient will conduct functional testing and answer questionnaires.~      The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.~   "
42987|NCT02494531|"~     The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two~     different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose -~     and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral~     metabolism dysfunction in literate versus illiterate MCI and AD patients.~   "
42988|NCT02494518|"~     The purpose of the study is to determine if performing different types of aerobic exercise~     (cycling) before upper extremity exercises will help to improve outcomes after stroke.~   "
42989|NCT02494505|"~     The main objective is to study if the mycophenolate could decrease the proportion of~     patients who relapse during the IVIG tapering period and after the IVIG withdrawal.~   "
42990|NCT02494492|"~     Uveitis is a leading cause of blindness in the children and young adult's populations. One~     third of etiology are idiopathic. The reference treatments are corticosteroids and~     immunosuppressive agents. They have significant side effects, and patient's compliance is~     often poor. In addition, some uveitis are more resistant. Also, in these situations of~     deadlock therapeutic, investigators propose a cell therapy by administering regulatory T~     cells (Tregs) in the vitreous of patients.~   "
42991|NCT02494479|"~     This study is designed to evaluate the efficacy and safety of Prurisol using three different~     oral daily dose regimens administered to subjects with active mild to moderate chronic~     plaque psoriasis.~   "
45467|NCT02461875|"~     The aim of study is to compare the efficacy of GnRH antagonist rescue combined with~     cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high~     risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.~   "
42992|NCT02494466|"~     Supraglottic airway equipment used during anaesthesia application can lead to airway~     reactivity or even larynx spasm in sensitive children.~      Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist~     which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of~     Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and~     corticosteroids.~   "
42993|NCT02494453|"~     Patients with breast cancer receive low doses to smaller volumes of the heart, but they also~     have an excellent long-term survival, so it is crucial to study the effects of low dose~     radiotherapy. Indeed, a recent study suggests that these effects can be seen within the~     first 5 years after treatment, and that there is no dose threshold. The investigators wish~     to develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying~     patients at increased risk for cardiac effects. These patients can then be targeted for~     close monitoring and early intervention, potentially with statins or ACE inhibitors.~     Additionally, by characterizing a time-course and radiation dose-volume relationship,~     potentially real-time modifications can be made to radiotherapy (RT) field design for~     patients sensitive to RT effects. Finally, this information can be incorporated into better~     designs of treatment plans for future patients.~   "
42994|NCT02494440|"~     The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of~     the fetal femur length at third trimester of pregnancy.~   "
42995|NCT02494427|"~     Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The~     current literature is weak and does not separate the medical results of these two~     techniques. However, the efficiencies enabled by CAD/CAM could, for the price of an initial~     investment, improve service to the patient by reducing the time required for these~     restorations, and possibly lower care costs.~      The aim of the study is to compare immediate medical results and short-term prosthetic~     restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic~     impacts and organizational aspects.~   "
42996|NCT02494414|"~     Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been~     extensively studied, highlighting a poor outcome (less than 8% at hospital discharge).~     However, little is known on mid and long-term prognostic factors and how these patients do~     survive from the event.~      Using a regional cohort, the aim of the study is to describe long-term survival rate of~     cardiac arrest survivors, and to assess the influence of treatment strategies on survival~     and functional outcome.~   "
42997|NCT02494401|"~     This Study is a collaborative project with partners (people with scleroderma and~     stakeholders) designed to refine an internet program for patients with scleroderma and to~     compare the internet program to an authoritative educational book (Taking Charge of Systemic~     Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled~     trial, the investigators will recruit up to 250 patients who will be randomized to either~     TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and~     Families.~   "
42998|NCT02494388|"~     The study is based on a multi-center approach of needle based confocal laser endomicroscopy~     (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA)~     to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological~     diagnosis.After detection of PCL, certain morphological EUS features allow the~     discrimination of specific cyst types. Additionally, EUS-FNA is recommended as the~     first-line procedure whenever pathological diagnosis is required; however the procedure has~     its drawbacks, mainly represented by the relatively low negative predictive value in~     diagnosing pancreatic cancer. In this case a more precisely diagnostic tool is required; the~     potential role of CLE has been explored in gastrointestinal (GI) pathology showing good~     accuracy for predicting the final histopathological diagnosis based on immediate evaluation~     of tissue and vascular patterns. Although the clinical impact of nCLE for the decision~     making algorithms in cystic pancreatic neoplasm has not yet been described, the hypothesis~     is that EUS-nCLE could allow targeted tissue sampling of cystic pancreatic neoplasms~     resulting in more accurate diagnosis. The aim of the study is to describe the clinical~     impact of nCLE for the clinical decision management algorithm based on EUS, EUS-FNA and/or~     EUS-CLE imaging criteria for cystic pancreatic neoplasms, while evaluating also the~     feasibility and safety of nCLE examination.~   "
42999|NCT02494375|"~     The primary goal of the study is to determine whether insufficient sleep is associated with~     poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether~     salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and~     somnolence, and whether insufficient sleep is linked to body composition. Sleep~     characteristics, glycemic control, salivary amylase and body composition will be assessed 3~     times, at 3-4 months intervals, in 82 type 1 diabetic children.~   "
43000|NCT02494362|"~     The purpose of the study is to determine whether a novel computer gaming hand exercise~     regimen would improve hand and arm function and be feasible in people with hemiplegia after~     Stroke affecting the hand.~   "
43001|NCT02494349|"~     The purpose of this study is to investigate and compare the pharmacokinetic characteristics~     and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and~     co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in~     healthy male volunteers.~   "
43002|NCT02494336|"~     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of~     trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for~     pediatric single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in~     children.~      Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary~     dyskinesia will be screened for study inclusion. Eligible patients and their~     parents/guardians will be approached and, if agreeable, consented for the study~     pre-operatively. Patients will be randomized to receive either trans-incisional rectus~     sheath block or intra-operative rectus sheath block under direct laparoscopic visualization.~     Both will be done by the attending pediatric surgeon. The patient, patient guardians, select~     research team members, and PACU staff will be blinded to the method of analgesic~     administration.~   "
43054|NCT02493439|"~     This study aims to test the efficacy of an intervention focused on promoting positive~     emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian~     immigrants living in Spain. It is hypothesized that the BPS intervention will significantly~     improve a series of positive mental health outcomes, i.e., optimism, future expectancies,~     and affect, compared to the Control group.~   "
43003|NCT02494323|"~     Seventy (70) subjects put on the Ness L300 System, a FES device for ankle dorsiflexion for~     patients with foot drop. Stimulation will be given through two different electrodes: the QFE~     which is a single channel stimulation, and the Segmented Electrode which is a dual channel~     electrode. The purpose of the dual channel stimulation is to enable a balanced dorsiflexion,~     with no inversion/eversion inclinations. Ankle elevation will be recorded both in a seated~     position and during gait. Subject preference will be recorded through BSW Questionnaire and~     Subjective Survey. Twenty first subjects will be stimulated with four different dual channel~     configurations. The configuration that shows to have an advantage over the others will~     continue to be evaluated on fifty additional subjects. Same procedure will be taken place,~     in addition ambulation tests will be performed.~   "
43004|NCT02494310|"~     A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to~     follow-up associated with the mobile screening program and demonstrate POC diagnosis by~     HRME. The mobile diagnostic and treatment unit will be equipped with the tools and~     infrastructure necessary to perform HRME, VIA, colposcopy, biopsy and treatment with~     cryotherapy. A team of a colposcopist, nurse, nursing assistant, and driver will staff the~     mobile diagnostic and treatment unit. The unit will travel to offer follow-up diagnostic and~     treatment services to women who have screened positive during a prior visit with the mobile~     screening unit. The mobile diagnostic and treatment unit will be constructed and maintained~     at BCH.~   "
43005|NCT02494297|"~     This study is designed to compile the reasons and specific indications for the prescription~     of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary~     objective of the study is to characterize the prescribing behaviors for Cyproterone Acetate~     combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France,~     the Netherlands, and Spain), including:~        -  prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol~        -  use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the~          updated label~        -  concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined~          hormonal contraceptives~        -  second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the~          indication acne~   "
43006|NCT02494284|"~     The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT)~     followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies~     (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding~     complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients~     after zotarolimus-eluting stent implantation.~   "
43007|NCT02494271|"~     The purpose of this retrospective study was to evaluate the incidence of SSI after~     colorectal surgery under the general anesthesia by different general anesthetic technique:~     inhalation versus total intravenous anesthesia.~   "
43008|NCT02494258|"~     Rollover study supporting solid tumor and hematological disorder indications from Celgene~     sponsored CC-486 protocols eligible for participation in the study.~   "
43009|NCT02494245|"~     The aim of the study is to compare physical activity in stroke survivors who have undertaken~     a four month physical activity intervention using the STARFISH application with a control~     group receiving four months of usual care.~   "
43010|NCT02494232|"~     Thoracic traumas are frequent causes of emergency department admissions and the third most~     common cause of death from trauma. Although emergency management of major thoracic traumas~     that have high mortality and morbidity were discussed and well-understood in detail in the~     literature, there are limited information regarding diagnosis, emergency management,~     treatment and follow-up after discharge of patients with minor blunt thoracic traumas.~      The investigators aimed to investigate demographic data, physical examination findings, and~     the relationship between lung injury, emergency department final diagnosis, hospitalization,~     discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions~     of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.~   "
43011|NCT02494219|"~     Comparison of Immunochromatographic Test for rapid detection of group A streptococcal~     antigen with culture in Pediatric patients.~   "
43012|NCT02494206|"~     The purpose of this study is to assess the efficacy of QBX258, a compound developed by~     Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with~     stage I-II breast cancer related lymphedema.~   "
43013|NCT02494193|"~     In deep carious lesions, presenting risk of pulp exposition, a treatment option is the~     partial caries removal of carious tissue followed by provisional restoration, while this~     approach is called indirect pulp capping. The aim of this double-blinding controlled~     randomized clinical trial is to evaluate the success of indirect pulp capping using only~     resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as~     control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions,~     from patients with age between 15 and 30 years treated in dental clinic at Department of~     Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3~     of dentin, observed in bite-wing radiography, without pulp involving and/or other factor~     that to compromise the evaluation. After detailed anamneses, the selected teeth will be~     radiographed e all carious tissue from surrounding walls will be removed. At the floor of~     cavity, the carious tissue will be partially removed using hand dentin excavators, remaining~     the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from~     the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans,~     while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly,~     the cavity will be provisionally restored with: Control - dress and cement of calcium~     hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass~     ionomer. The distance between the base of restoration and the pulp cavity cap will be~     measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while~     the teeth with compromised pulp vitality will be excluded from the study. The remaining~     patients will be evaluated after 6 months. The distance between the base of restoration and~     the pulp cavity cap will be measured again, followed by provisional restoration removal. The~     remaining caries-affected dentin from floor of cavity will be fully removed and a~     bacteriological evaluation performed. The consistency, colour and humidity of this tissue~     will be evaluated too. Finally, the permanent restorations will performed.~   "
43014|NCT02494180|"~     The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in~     terms of the pain levels and post-operative side effects of TUGOR~   "
43026|NCT02493803|"~     The aim of this research is to investigate the impact of dietary advice on the progression~     of tooth wear over 6 months using a randomised clinical trial design. Participants with~     severe tooth wear will be recruited. Half of those patients will receive a detailed dietary~     advice and the other half will be receive standard of care dietary advice. Moulds will be~     made of their mouths at the original appointment and 6 months later. These moulds will be~     scanned and superimposed to see if there is any difference in their level of tooth wear~   "
43326|NCT02489903|"~     The study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize~     small cell and non-small cell lung cancer, ovarian cancer and high grade neuroendocrine~     tumor patients who previously responded and now have failed a platinum based doublet to the~     previously effective therapy.~   "
43015|NCT02494167|"~     This research study uses special blood cells called multiple tumor-associated antigen~     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid~     leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or~     has not gone away after standard treatment, including an allogeneic hematopoietic stem cell~     transplant (HSCT).~      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin~     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in~     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This~     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are~     able to hide from the body's immune system and escape being killed. The investigators~     previously tested whether special white blood cells (called T cells) that were trained to~     kill EBV-infected cells could affect these tumors, and in many patients the investigators~     found that giving these trained T cells causes a complete or partial response.~      In several lymphomas and other types of cancer like AML or MDS, the cancer cells do not have~     EBV. The do however express other proteins that can be targeted in the same way. The~     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with~     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment~     appears to be safe. Therefore, the investigators now want to test whether the investigators~     can direct these special T cells against other types of cancers that carry similar proteins~     called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so~     they either do not show up, or show up in low quantities, or normal human cells.~      The investigators will grow T cells from patients' stem cell donors in the laboratory in a~     way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin,~     which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30~     days post-allogeneic stem cell transplant. In this study, the investigators want see whether~     these cells will be able to recognize and kill cancer cells that express these proteins.~     These donor-derived multiTAA-specific T cells are an investigational product not yet~     approved by the U.S. Food and Drug Administration~      The purpose of this study is to find the largest safe dose of donor-derived tumor protein~     multiTAA-specific T cells for patients with AML or MDS.~   "
43016|NCT02494154|"~     This study evaluates the work of breathing among patients under various conditions of~     treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with~     respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is~     a cross over of four treatment periods with different flow settings.~   "
43017|NCT02494141|"~     The proposed research will determine the effectiveness of curcumin for improving the health~     and function of arteries in children and young adults with autosomal dominant polycystic~     kidney disease (ADPKD). The study also will provide insight into how curcumin improves~     artery health by determining the physiological mechanisms (biological reasons) involved and~     offer exploratory evidence if curcumin can slow kidney growth. This will be done by~     comparing these measurements in children and young adults who are randomized to receive~     either curcumin or placebo for 1 year.~   "
43018|NCT02494128|"~     All parents in Sweden are offered group based parental support within Child Health Service~     (CHS) but only 40% participate. Nurses feel insecure in their group leadership and express a~     need for education in group leadership and group dynamics. Most CHC nurses do not have~     formal education or training in group leadership and the aim of this study was to evaluate a~     group based education program in group leadership for Child Health Care (CHC) nurses.~   "
43019|NCT02494115|"~     Physical embarrassment, pain and psychological impact linked to the body image distortion~     are often associated to these lymphedemas. Investigators decided to study new therapeutic~     method because of major discomfort due to these oedemas and doctors' difficulty to manage~     them.~      Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This~     local treatment consists in inserting in lower limbs several catheters draining into~     enclosed bags in order to evacuate lymph fluid and to lower local pressure.~      Very few studies have been published concerning this technique and are presenting only a~     small number of cases. They cannot allow clear conclusions of this technique's efficiency~     but show encouraging results.~      Investigators want to collect more data on this technique using a larger number of subjects~     in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer~     patients presenting lower limbs lymphedema. Investigators will consider as lymphedema,~     oedemas with no renal or cardiovascular identified cause and excluding anasarca.~   "
43020|NCT02494102|"~     The purpose of this study is to determine whether modafinil use in patients with obstructive~     sleep apnea will improve postoperative delayed emergence after general anesthesia.~   "
43021|NCT02494089|"~     Vulnerability to psychologic distress induced by in situ simulation.~      Objectives: Psychological evaluation at short and long term on working satisfaction, mental~     health, and acute stress after in situ simulation. Analysis of the stress vulnerability~     induced by simulation.~      Design: non interventional study.~      Primary outcome: Psychologic distress analysis with validated psychologic distress inventory~     (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale~     Revisited (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B~     (STAI-B)).~   "
43022|NCT02493855|"~     This is a study of ombitasvir/ABT-450/ritonavir and dasabuvir with low dose ribavirin (RBV),~     full dose RBV or RBV add on in treatment naive subjects with chronic Hepatitis C Virus~     (HCV).~   "
43023|NCT02493842|"~     Background:~      Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not~     well known what causes PLP to develop and the current treatments have been shown to be~     largely ineffective. Resent research, however, have indicated that cortical reorganizing~     occurring after amputation of the cortex areas related to the missing limb may be related to~     the development of PLP. Furthermore, the research indicated that by providing meaningful~     sensory input coming from the phantom limb the PLP may be alleviated and the cortical~     organization normalized.~      Aim:~      The CIP described in the current application, is part of a the EU-project EPIONE, which~     aims to investigate if and how cortical normalization and PLP alleviation can be induced by~     providing phantom limb sensations (sensations which seems to originate from the missing~     limb) in hand amputated subjects.~      Method:~      In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand~     amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes~     in the arm stump for up to one year.~      Therapy will be evaluated in two stages, first during a standardized four week phase where~     the subject receives daily therapy. If the therapy is shown to be effective, therapy may be~     reinitiated during a second longer therapy phase.~      During the therapy sessions, selective nerve stimulation will be performed. The amputee will~     experience this as sensations (movement, touch, temperature, vibration etc.) originating~     from the phantom limb. While implanted, we will investigate how well we can induce these~     sensations and we will provide a stimulation therapy, which consist of stimulation~     activities which requires the subject to focus on the evoked sensations. Prior to, during a~     and following therapy a series of assessments (standardized across all EPIONE partners to~     enable comparison) will be conducted to relate therapy with PLP, cortical organization, the~     mental state etc. of the subject.~      Expected outcome:~      The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The~     experience we gain might be used for deriving clinical guidelines on how to treat PLP.~   "
43024|NCT02493829|"~     The study will be an open label, single arm, phase I study intended to identify the safety~     and tolerability of AML Cell Vaccine given to eligible MDS RAEB-2 and AML patients who~     have achieved a best response of complete remission or partial remission following their~     first or second course of standard induction chemotherapy.~   "
43025|NCT02493816|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is a severe form of blistering skin~     disease caused by mutations in COL7A1 gene. This study aims to assess the safety of~     intradermal injections of gene-modified autologous fibroblasts in 5-10 adults with RDEB.~   "
43027|NCT02493790|"~     Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point~     characterized by multiple systemic effects as cognitive dysfunction. This one seems to have~     an impact in activity daily living, considered mainly as a cognitive-motor dual task~     situations. Yet to date, no study has specifically focused in the cognitive-motor~     performance in patients with COPD or on the effects during a rehabilitation program. The~     main objective of this work was to evaluate the impact of cognitive dysfunction in COPD,~     comparing performance between COPD patients and healthy subjects in a single and dual task~     cognitive-motor situation. The secondary objective was to assess the impact of a~     rehabilitation program on these performances.~   "
43028|NCT02493777|"~     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in~     patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a~     6-week open-label treatment optimization period followed by a one week randomized,~     double-blind, placebo-controlled test phase.~   "
43029|NCT02493764|"~     This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a~     fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with~     hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is~     that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.~   "
43030|NCT02493751|"~     This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the~     maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab~     (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab~     administered in combination with axitinib is estimated (dose finding portion), the dose~     expansion phase will be opened to further characterize the combination in term of safety~     profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.~   "
43031|NCT02493738|"~     Study Objectives:~        -  To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and~          fed condition in healthy male subjects~        -  To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under~          fed condition in healthy male subjects~        -  To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in~          Korean healthy male subjects~   "
43032|NCT02493725|"~     Guillain-Barré syndrome (GBS) is an immune-mediated polyneuropathy that usually follows an~     antecedent infection and causes acute neuromuscular paralysis. GBS is currently classified~     into the two major subtypes: a classical demyelinating type and axonal variant type. Whereas~     in Europe and North America demyelinating GBS is the major subtype, in East Asia and Central~     and South America, axonal GBS is found in 30~65% of patients. Although the pathophysiology~     of GBS has not been fully understood, major advances have been made in understanding the~     pathophysiology particularly for the axonal form of GBS. It is now established that axonal~     GBS is caused by molecular mimicry of human gangliosides by the Campylobacter jejuni~     lipo-oligosaccharides. Autoantibodies bind to GM1 or GD1a at the nodes of Ranvier, activate~     complements, and disrupt sodium channel clusters and axo-glial junctions, resulting in the~     nerve conduction failure and muscle weakness. C. jejuni infection induces production of~     antibodies, which cross-react with gangliosides on the human nerve axolemma, and activate~     the complements, resulting in formation of membrane attack complex (MAC). The pathology~     leads to axonal degeneration.~      The standard treatments for GBS are plasma exchange and intravenous immunoglobulin and the~     disease progression reaches its nadir within 4 weeks. However, during the acute phase, 18-28~     % of the patients require artificial ventilation and 4.1-6.3 % of the patients die of~     complications. Recovery takes several months or years, and 16.7-19.7 % of the patients still~     require aid to walk one year after onset. Because of such serious disability of GBS~     patients, an alternative novel therapy that can prevent death during acute phase or severe~     sequelae is needed.~      Eculizumab is a humanized monoclonal antibody of murine anti-human C5 antibody and~     specifically binds to the final activation complement component C5 and inhibits MAC~     formation by suppressing the cleavage reaction of C5 into C5a and C5b. The efficacy of~     eculizumab against GBS has been shown in a model of axonal GBS. At present, there are no~     animal models of demyelinating GBS. However, autopsy studies have shown that C3d and C5b-9~     (MAC) are deposited on the Schwan cells, and therefore eculizumab can be effective also for~     demyelinating GBS.~      This clinical trial will be conducted to investigate the efficacy and safety of eculizumab~     for GBS to warrant future global clinical trials. Moreover, we also study the relationship~     between the efficacy and clinical subtypes of GBS, such as axonal or demyelinating form. Our~     trial will provide insights on whether the future global developmental plan should target~     the whole spectrum of GBS world-wide or focusing on Asia and South America.~   "
43033|NCT02493712|"~     IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed~     Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the~     clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week~     treatment period and 2 weeks follow up.~   "
43034|NCT02493699|"~     The purpose of the present study was to determine whether teaching Karate techniques~     training leads to reduction in communication deficit of children with autism spectrum~     disorders.~   "
43035|NCT02493686|"~     Examination of the bone conduction of persons which according to the pure tone audiogram~     have a normal age related hearing threshold in the air conduction.~   "
43036|NCT02493673|"~     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder~     associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate.~     A causal relationship between OSA and systemic hypertension as well as peripheral~     endothelial dysfunction was shown, and there is accumulating evidence from physiologic and~     observational studies that cerebral autoregulation is insufficient to protect the brain from~     the nocturnal consequences of OSA. However, there are no data from randomised controlled~     trials proving a causal relationship between OSA and impaired cerebral vascular reactivity~     (CVR). The aim of this randomised controlled trial is to study the effects of a short-term~     CPAP withdrawal, and thus returning OSA, on daytime CVR and brain oxygenation to establish~     whether there is a causal relationship between OSA and cerebral vascular damage.~   "
43037|NCT02493660|"~     A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation~     in comparison to surgical repair of full thickness Massive Rotator Cuff Tear (MRCT).~   "
43038|NCT02493647|"~     This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV~     prevention soap opera video series for smartphones or computers, in a randomized clinical~     trial among predominately at-risk African American urban women.~      The following hypotheses are to be tested: 1) The LSC treatment arm will show lower~     unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high~     risk partners at 6 months post intervention compared to an attention control arm 2) The LSC~     treatment arm will show higher participation in HIV testing at 6 months post intervention~     compared to the control.~      If effective, this video intervention could be rapidly implemented and brought to scale at~     low cost via the Internet, widely reaching young urban women with the goal of reducing HIV~     risk behavior and increasing HIV testing.~   "
45468|NCT02461862|"~     Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure~     and radial pulse) during the placement of the intrauterine device.~   "
43039|NCT02493634|"~     This is post-market clinical follow-up study on 25 consecutive patients in two centers to~     evaluate the safety and performance of magnetic resonance imaging conditional guide wire and~     the acceptability of identified risks in the clinical evaluation and to detect emerging~     risks on the basis of factorial evidence.The procedure will be done in patients with a~     clinical indication for cardiac magnetic resonance and conventional catheterisation.~   "
43040|NCT02493621|"~     The goal of this retrospective chart review is to evaluate if the implementation of lumbar~     plexus block placement for postoperative pain have improved conditions in the postoperative~     period for patients undergoing total hip arthroplasty when compared to the placement of~     epidurals for postoperative pain management.~   "
43041|NCT02493608|"~     The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision~     in pregnant patients undergoing repeat elective cesarean delivery.~   "
43042|NCT02493595|"~     The study will seek to understand the effective use of a novel Microwave Radar Breast~     Imaging System in a Symptomatic Breast Care Clinic. The MARIA Imaging system uses low level~     non--ionising radiation (radio wave) signals to scan the breast tissue volume and to provide~     a visual image of areas of varying tissue permittivity value within the volume. These areas~     of varying permittivity can be shown as a two or three dimensional image and used in~     conjunction with the X-Ray mammogram and ultrasound scans to provide another level of~     diagnosis to the radiologist.The system works equally well in both dense and lucent breast~     types and can in particular provide insight into the diagnosis in dense tissue cases. The~     trial will accept symptomatic cases with suspected cancer, cysts or fibroadenoma.~      The trial will use the images produced by the MARIA system and compare them to the images~     obtained using X-Ray mammography. The results of the comparison will be assessed to~     understand the effectiveness of the MARIA image in assisting with the identification and~     location of suspected lesions for further specific analysis using Ultrasound/Biopsy.~   "
43043|NCT02493582|"~     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with~     cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced~     lung adenocarcinoma patients with wild-type EGFR~   "
43044|NCT02493569|"~     The purpose of the study is to study the epidemic features and diagnosis of female breast~     cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival~     (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.~   "
43045|NCT02493556|"~     Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular~     damage have been studied over the last years. Studies have been conducted on animals and~     humans in order to try to show the benefits of the intervention, but there is still~     conflicting evidence about its protective and therapeutic effects.~      Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation~     after plyometric exercise.~      Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20~     male healthy volunteers will be performed. Healthy and physically active individuals, aged~     between 18 and 35 years, with no history of injury on the lower limbs or contra-indications~     to maximal exercise performance will be included. A protocol of 10 series with 10~     repetitions of the countermovement jump will be used to induce muscle damage at the lower~     limbs. Immediately before or after the exercise protocol, LLLT will be applied on one lower~     limb, while the other will receive placebo treatment. Phototherapy will be applied with an~     equipment of 810nm and a cluster with 5 diodes on 8 different points of the knee extensor~     muscle, totalizing a dosage of 240J. The placebo treatment will be held on the same way, but~     the equipment will be turned off. The volunteers will be evaluated at baseline (before the~     exercise protocol) and at follow-up of 24, 48 and 72 hours. The following outcomes will be~     evaluated: knee extensors isometric peak torque by Isokinetic Dynamometer, pain by Visual~     Analogue Scale and muscular tissue echo intensity by Ultrasonography.~   "
43046|NCT02493543|"~     The purpose of this study is to determine the autoantibody profiles after spinal cord injury~     and their role in spontaneous functional recovery.~   "
43047|NCT02493530|"~     This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered~     together with ruxolitinib in patients with myeloproliferative neoplasms (specifically:~     polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.~   "
43048|NCT02493517|"~     The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg~     with lanreotide 40mg PR in subjects with active acromegaly.~   "
43049|NCT02493504|"~     Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for~     dialysis. Measures such as systemic anticoagulation have been proposed as means of~     increasing patency rates but enough evidence does not exist to support their use. The~     investigators aimed to evaluate the efficacy of preoperative heparin injection on patency of~     AVF during the first 24 hours after surgery and to determine whether such measure can be~     used to prevent early thrombosis of the vascular access.~   "
43050|NCT02493491|"~     The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e.~     non-interventional, exploratory). Patient data collected from the registry is expected to be~     consistent with any information which can be obtained during usual care of patients with~     dysphonia/dysphagia treated with vocal fold augmentation.~   "
43051|NCT02493478|"~     Advanced airway interventions are common high risk, high stakes events for children in~     intensive care units (ICU) and emergency departments (ED), with risk for life and health~     threatening consequences.~   "
43052|NCT02493465|"~     This is a prospective, open label, single-center study, in kidney transplant recipients with~     stable renal function for 12 and 120 months after transplantation, that are in use use of~     calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular~     hypertrophy will be investigated before and after conversion of azathioprine to everolimus.~      This study will evaluate as primary objectives: the prevalence of left ventricular mass~     hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability~     of everolimus to reduce left ventricular mass after conversion from Azathioprine, using~     sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR)~     at 3 and 6 and 12 months after conversion, number and severity of episodes of acute~     rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.~   "
43053|NCT02493452|"~     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,~     parallel-group clinical trial with 12 weeks of study drug therapy.~   "
43055|NCT02493426|"~     Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders.~     Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This~     study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity~     and social perception tasks. Taking OT as a spray through the nose increases social and~     decreases repetitive behavior in some adults with ASD, and we are exploring if it helps~     children with ASD similarly. However, it is unclear whether every person with ASD has an~     abnormal OT level, and if OT affects restrictive or social behavior differently.~     Consequently, we aim to study whether OT treatment can be effective in treating subgroups~     with specific features of ASD. We will use approaches utilizing both behavioral and~     physiological responses to clarify the role of OT in ASD. We will develop a deeper~     understanding of the range of social and rigid behaviors and use that information to~     identify persons with ASD who would benefit from OT treatment. Potential subjects will be~     asked if they want to participate in two sessions in our clinical laboratory where they will~     get either single dose IN-OT or placebo. After receiving the substance, they will be asked~     to do a handful of tasks while we monitor heart rate, eye movements, and collect baseline~     and post intranasal blood, urine and saliva. The levels of hormones, metabolites and~     peptides related to or interacting with OT will be measures in the collected samples of~     blood plasma, urine and saliva. Additionally DNA will be extracted from the blood samples to~     study genes related to OT and ASD.~   "
43056|NCT02493413|"~     The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI)~     inquired by DS14 score in type D personality (distressed personality) to the relation of~     autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese~     patients within coronary heart disease group (CHD). As stress is the key psychological~     activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important~     risk factor for diminished immune competency and prevalence of chronic conditions such as~     obesity, investigators chose exercise as the stress release intervention, especially as~     chronic stress may have a role in obesity, related to initiation or exacerbation of the~     condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally~     associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present~     in visceral adipose tissue and may contribute to local inflammatory cell activation before~     the appearance of macrophages, suggesting that these cells could play an important role in~     the initiation and perpetuation of adipose tissue inflammation.~   "
43057|NCT02493400|"~     To investigate the effect of exercise or PAP prescription 3 months after completion of the~     study Should elderly patients with atrial fibrillation be offered physiotherapist group~     exercise or can physical activity on prescription (PAP) be used as an alternative?~     regarding level of physical fitness, physical activity, heart rate and health related~     quality of life (HR-QoL). Also if any of the investigated variables can predict the possible~     change in physical fitness.~   "
43058|NCT02493387|"~     Atrial fibrillation is the most common arrhythmia, and physical activity and exercise are~     sometimes avoided due to symptoms such as palpitations, fatigue and anxiety.~     Physiotherapist-led group based exercise as part of cardiac rehabilitation is rare for this~     group of patients, the method physical activity on prescription is used to encourage the~     patient to increase their physical activity level in order to reduce the risk of premature~     morbidity and mortality. However, mostly in this method you do not know the patient's~     ability to perform the prescribed amount of physical activity, and its effect on physical~     fitness has not been studied in patients with heart disease, neither has the effect of~     physiotherapist led group-based exercise in patients with atrial fibrillation. The aim was~     to investigate the impact of physiotherapy led group-based exercise compared to physical~     activity on prescription in patients with atrial fibrillation regarding the level of~     physical fitness, physical activity, heart rate and health related quality of life (HR-QoL).~   "
43059|NCT02493374|"~     This is a study of people with type 2 diabetes and high cholesterol between age 18 and 65.~     This study is trying to figure out if a partial bypass of the small intestine can reverse~     type 2 diabetes for people who require cholesterol lowering and who cannot tolerate the~     statin drugs.~   "
43060|NCT02493361|"~     This is a multi-center, Phase II, open label, single-arm trial of intratumoral pIL-12 EP in~     combination with pembrolizumab in patients with low TIL melanoma. Patients will initiate~     treatment of pembrolizumab concurrently with the first cycle of intratumoral pIL-12 EP.~     Pembrolizumab will be administered at 200 mg flat dose every 3 weeks. Cycles of intratumoral~     pIL-12 EP (each cycle consisting of treatment on days 1, 5 and 8) will occur every 6 weeks~     as long as patients have accessible lesions for EP. Patients will be evaluated for response~     every 12 weeks by RECIST v1.1. Patients will continue on therapy if they have stable disease~     or better, defined under investigator evaluation at the time of disease evaluations. Therapy~     will be given until disease progression or unacceptable toxicity. The only exception will be~     those patients who experience a confirmed CR and who have been on treatment for at least 6~     months; these patients may discontinue treatment at the investigator's discretion. Patients~     may reinitiate either therapy post-complete remission relapse if the study remains open and~     the patient meets the conditions outlined in the protocol. Patients will be followed~     continually for safety and tolerability by assessment of adverse events.~   "
43084|NCT02493049|"~     The first major objective of this pilot trial is to demonstrate that it is possible to study~     myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing~     lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible~     the investigators will recruit 24 RRMS patients who are being treated with standard disease~     modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI~     scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The~     second major objective is to determine how much repair occurs in participants treated with~     domperidone compared with those who are not treated. This will allow us to design larger~     trials to confirm that domperidone improves repair. The study will also confirm the safety~     and tolerability of domperidone in RRMS, determine circulating prolactin levels during~     dosing with domperidone 10mg three times daily in people with RRMS, and explore the impact~     of other clinical factors (such as age) on lesion repair.~      In addition, blood will be collected to test for metabolomics and the investigators will~     bank blood for future study of biomarkers that can help the investigators better understand~     MS. Metabolomics is an experimental test where changes in the pattern of the chemicals in~     blood cells are compared at different time points (during and after inflammation). There~     will be random changes but changes that are common in most study participants may help~     identify chemicals that signal stages in injury or repair. The investigators will also~     compare the pattern of change in those with the best repair to those with the worst repair.~     This may help identify a chemical that is associated with better or worse repair and help~     develop new treatment strategies. There are currently no blood tests that help in the~     diagnosis of MS, help determine which drug a person will respond to, or help determine a~     person's expected MS outcome. Any such tests would be considered biomarkers.~   "
43061|NCT02493348|"~     Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically~     impacts patient's quality of life. Its exact cause has not yet been identified, however~     recent studies have indicated that fibromyalgia is associated with significant imbalance of~     the connectivity within brain networks associated with pain, decreased functional~     connectivity in the descending pain-modulating system, and increased activity in the pain~     matrix related to central sensitization. It has been suggested, therefore, that treatments~     that induce coherent neuronal activity, and/or stimulate synchronization of dysregulated~     brain circuitry, have significant benefits, improving pain management and enhancing~     patient's quality of life. Rhythmic Sensory Stimulation (RSS) is an example of a~     non-invasive treatment that is thought to indirectly stimulate neuronal coherence. The~     present research proposal aims to determine the effectiveness of Rhythmic Sensory~     Stimulation with 40 Hz sound on the treatment of fibromyalgia. The proposed treatment~     involves 30 minutes of daily rhythmic vibroacoustic stimulation at 40 Hz, 5 days per week,~     for 5 weeks. The treatment is self-administered by the patients at home with the Sound Oasis~     Vibroacoustic Therapy System (VTS) 1000 portable device. Measures of pain severity,~     fibromyalgia symptoms, sleep quality, and depression, will be compared before and after~     treatment between the treatment and control groups. The results of the present study will~     help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment~     of chronic pain disorders, such as fibromyalgia, and contribute to the development of future~     studies to investigate the neural driving effects of therapies based on Rhythmic Sensory~     Stimulation.~   "
43062|NCT02493335|"~     The purpose of this study is to prove the superiority of a 48-weeks treatment with~     budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological~     remission in patients with eosinophilic esophagitis.~   "
43063|NCT02493322|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
43064|NCT02493309|"~     The purpose of this study is to determine whether an individuals cardio-respiratory fitness~     level can protect them from the negative metabolic impacts of prolonged sitting time.~      Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect~     of prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will~     not be as substantial, nor will light activity breaks be as advantageous, compared to~     individuals with lower fitness as they have a smaller scope for metabolic improvement.~   "
43065|NCT02493296|"~     The present study will investigate the effect of artificially stiffening the aorta by means~     of an aortic stent on central aortic haemodynamics (CAH). This study will determine whether~     aortic stenting inadvertently adversely impacts on CAH, thereby providing the rational for~     subsequent therapeutic intervention to reduce the associated cardiovascular risk.~   "
43066|NCT02493283|"~     The objectives of the study are~        -  to evaluate pharmacokinetics, distribution in blood leucocytes, metabolism and~          methemoglobinemia after single-dose and repeated-dose administration of 100 mg of~          dapsone in healthy subjects genotyped for CYP2C9 and NAT2~        -  to evaluate serum through levels, distribution in blood leucocytes and~          methemoglobinemia after repeated-dose treatment with dapsone in patients with~          autoimmune bullous dermatoses before and after concomitant treatment with~          glucocorticoids~   "
43067|NCT02493270|"~     The aim of this prospective study is to verify the efficacy of smoking cessation on~     non-surgical periodontal therapy in adult subjects with chronic periodontitis.~      Smokers that were willing to quit received periodontal treatment and concurrent smoking~     cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated~     examiner, blinded to smoking status, assessed periodontal status, gathered demographic and~     behavioural information with a structured questionnaire and measured air carbon monoxide~     concentration measurements.~   "
43068|NCT02493257|"~     The proposed study seeks to investigate the effect of intranasal capsaicin treatment in~     patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry~     (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after~     treatment.~   "
43069|NCT02493244|"~     Tears play a vital role in vision. A thin layer of tears is always present to cover the~     surface of the eye for optimal comfort and vision. There are several layers to the tear~     film, and the outer most layer is comprised of lipids. This lipid layer prevents evaporation~     of the tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning~     eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some~     patients, and the purpose of this study is to evaluate the tear film lipid layer thickness~     before and after one months treatment with Cliradex Wipes.~   "
43070|NCT02493231|"~     Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a~     vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies~     report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is~     non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for~     postoperative pain control, and reduce the needs of opioid.~   "
43071|NCT02493218|"~     Effective strategies to ameliorate the negative effects of stressful urban living are~     greatly needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based~     instructional program of stress-reduction techniques, found to reduce mental health problems~     across many adult populations.~      The investigators propose to conduct a randomized controlled trial of the 12-week~     school-based DSB program compared with a 12-week school-based health education control~     program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for~     mental health and behavioral problems among public middle-school students.~   "
43072|NCT02493205|"~     The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in~     conducting impant procedures in the holding area of a hospital operating room vs cardiac~     catheterization/electrophysiology laboratory.~   "
43073|NCT02493192|"~     The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical~     Trial comparing the two methods of pain relief in the first time of labour was carried out.~     In this study, 110 women in the first stage of labour were allocated in two study groups by~     a randomised block design. One of them used the birth ball as a pain relief method,and the~     other one used pethidine and haloperidol injection.~   "
43074|NCT02493179|"~     The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase~     (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled~     study.~   "
43075|NCT02493166|"~     Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the~     central nervous system, with more than 2.5 million people in the world. It is the most~     non-traumatic cause of disability in young and middle-aged adults.~      Because the lesions are spread in the brains, there is a variety of symptoms. The most~     common symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of~     them after 15 years, have problems with movements in one or both upper extremities.~      Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although~     they are less visible, they can have a major determining influence on social or work-related~     domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of~     information processing, impaired memory and limited executive functions.~      When a combination, of motor and cognitive task, is asked, the execution of these tasks~     could be difficult with the foregoing in mind. For example problems during chatting while~     cooking, typing a report at a meeting or watching television while ironing.~      The dual-task paradigm assumes that the attention should be divided between two simultaneous~     tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit~     the separate task versus simultaneously.~      Research on dual tasking with persons with MS has already studied extensively, but not~     specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary~     research on the DTC. They combined the movements of the upper limb with a cognitive task.~     The research showed a difference between Persons with MS and the control group. At~     methodological level, there is lacking on the randomization of tasks. That is an important~     bias because of the learning effect of the tasks. They used only one task for the upper~     limb; this isn't enough to generalize the concept of motor interference in Persons with MS.~      The study has two research questions:~        -  Have Persons with MS a greater DTC compared with a healthy control group? The motor~          task is executed with the upper limb.~        -  Is there a difference on DTC in persons with MS depending on the motor task?~      This research is an observational case-control study in which individuals with MS will be~     compared to a healthy control group. They will be two moments of assessments. On the first~     day the general performance of the persons will be measured, by using clinical evaluation~     tests and questionnaires. On the second day they will be tests on the dual tasks, specific a~     comparison between single versus simultaneously performed tasks.~   "
43076|NCT02493153|"~     The investigators are very pleased to register the study entitled A prospective study for~     the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months~     after cholecystectomy with Ultrasound.~      This study deals with prospective ultrasound study about hepatic steatosis development 3~     months after cholecystectomy. This study was approved by the Institutional Review Board of~     the local institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after~     cholecystectomy was carried out in 82 patients with gallbladder disease. In conclusion, the~     investigators thought that cholecystectomy might be considered as a risk factor for hepatic~     steatosis.~   "
43077|NCT02493140|"~     The purpose of this study is to assess the efficacy and safety of a cashew apple extract on~     weight management and associated metabolic risk factors in overweight/obese volunteers,~     versus placebo, after 12 weeks of treatment.~   "
43078|NCT02493127|"~     Objectives:~      To determine the association between priming and measurements of hand function such as grip~     strength~      Primary null hypothesis:~      There is no difference in grip strength (best of three attempts) as a percent of the~     opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS)~     compared to patients that complete the positively adjusted PCS.~      Secondary null hypotheses:~      There is no difference in grip strength (last of three attempts) as a percent of the~     opposite hand between patients that complete the standard PCS compared to patients that~     complete the positively adjusted PCS.~      There is no difference in grip strength (best of three attempts) before and after completing~     the questionnaires between patients that complete the standard PCS compared to patients that~     complete the positively adjusted PCS.~   "
43079|NCT02493114|"~     This trial investigates the impact of curative lung cancer treatment on functional status~     and exercise tolerance. Furthermore this trial investigates possible underlying causes and~     consequences of deconditioning.~   "
43080|NCT02493101|"~     The purpose of this study is to determine the location of periostin and urine periostin~     level in patients with lupus nephritis and IgA nephropathy.~   "
43081|NCT02493088|"~     The prediction of dangerousness remains a delicate subject, relevant in current psychiatry.~     Scalable psychopathological elements identified in schizophrenia and mood disorders are~     considered as most at risk for crime committing. The French High Authority of Health (HAS)~     recommends to identify and prevent risk situations of violence and to develop research at~     this level. Some authors have worked on criminal career and became interested in risk~     factors for aberrant driving behaviors but also in environmental or clinical elements~     accompanying these phases. To our knowledge, no specific study about contextual elements~     before misconduct and which could lead to aberrant driving behaviors among individuals~     diagnosed with antisocial personality disorder has been described to date The investigators~     propose to follow individuals diagnosed with antisocial personality disorder in prison~     during 6 months in order to list their conduct disorders and contextual elements upstream of~     these misconducts. The investigators will also study the effect of contextual factors~     related to judicial steps on the appearance of aberrant driving behaviors.~   "
43082|NCT02493075|"~     The objective of the study is:Phase I: To validate or otherwise determine the~     Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the~     effectiveness and safety of ablation guided by the appropriate contact force.~   "
43083|NCT02493062|"~     This study is to review how the uterus heals after having open fetal surgery. Open fetal~     surgery causes a scar perhaps two: one from the open fetal surgery and a second from~     delivery by cesarean section; rarely, the same area of your uterus was used for both open~     fetal surgery and delivery. From other studies of surgery performed on a uterus, some of the~     uterine scars do not heal well. This study's intervention uses sterile saline to spread open~     the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An~     ultrasound is performed to take pictures of the uterus, its inside and the walls of the~     uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound~     and evaluated. This is performed at least 6 months after delivery.~      Primary Outcome:~      Measure the depth of the scar and location of the scar 6 months or longer after delivery.~   "
43085|NCT02493036|"~     A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of~     SYN-010 in Patients with Irritable Bowel Syndrome with Constipation~   "
43086|NCT02493023|"~     Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires~     optimal sampling precision.Electromagnetic navigation systems are promising for~     intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy~     depends largely on correct alignment of preoperative images to the patient´s position in~     space during endoscopy. In this study, the accuracy of a new fast and automatic~     image-to-patient registration method during the initial phase of bronchoscopy is assessed in~     patients referred for lung cancer investigation.~   "
43087|NCT02493010|"~     The primary objective of the study is to examine the safety, usability and preliminary~     efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The~     investigators hypothesize that after 8 weeks of hour-long interventions, participants will~     show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.~   "
43088|NCT02492997|"~     The octipolar applicator is intended for circumference reduction treatment by reduction of~     adipose size and enhancement of collagen synthesis as the result thermal and non-thermal~     collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF)~     and pulsed electromagnetic fields (PMF) treatment on circumference reduction.~   "
43089|NCT02492984|"~     An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and~     efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia~     A in usual care settings in China for approximately 6 months or or approximately 50 exposure~     days whichever occurs first~   "
43090|NCT02492971|"~     Appropriate assistive devices are important factors for the activity participation of the~     disabled. These devices should be prescribed by the specialists based on their functional~     needs. However, most individuals in need of assistive devices locate in the household,~     school, or nursing institute, in which the professional interventions are not always~     available on demand. Consequently most assistive devices are used without thorough~     evaluation, therefore do not necessarily meet the exact needs of the individual. Hence an~     easy-to-access and easy-to-use assistive technology device indexing system based on the~     functional needs of the subjects is necessary. The goals of this two-year study are twofold:~     assistive technology indexing system application(APP) development and promotion. First, the~     multidisciplinary research team, composed of specialists from assistive technology,~     rehabilitation, computer science, and special education fields, is going to integrate and~     refine the current resources and develop an assistive technology indexing system App based~     on the functional needs of the disabled. Second, in cooperation with the disabled community~     and special schools, the team is going to promote the use of the App and evaluate its~     usability via System Usability Scale. This App will be beneficial to the individuals in need~     of assistive device application. It can also be used as an assistive device manual for the~     specialists. The App will guide the individuals step by step to the proper assistive devices~     based on their functional capacities. The complete system will include details of each~     assistive device and link up with the related service resources. With its registering~     function, the statistics collected via user clicks can serve as references for further~     design adjustments and assistive device related policy modifications. All together this App~     can provide comprehensive services to the disabled in need of assistive devices.~   "
43091|NCT02492958|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a~     single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86~     years.~   "
43092|NCT02492945|"~     This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the~     lateral epicondylitis with ultrasonography-guided injection of the PDRN or dextrose~     solution.~      Condition: lateral epicondylitis~      Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as~     prolotherapy, active control~      Phase 4~      Study type: Interventional~      Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer,~     Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study~      Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient~     with elbow epicondylitis in randomized double-blind active-control comparative study~      Estimated Enrollment: 40~   "
43093|NCT02492932|"~     Two approaches are possible when the first finder needle attempt of the internal jugular~     vein cannulation fails; the needle can be turned slightly laterally or the puncture point~     can be moved slightly medially. This study is an ultrasonographic stimulation study to~     evaluate the success rate of turning the needle laterally and moving the puncture point~     medially, and to determine the proper angle or distance for the second try of internal~     jugular vein cannulation.~   "
43094|NCT02492919|"~     There is a growing incidence of sepsis and septic shock in people after surgery, for which~     there may be several reasons: more elderly people and more severe illnesses are entering~     operating theatres, more invasive systems are being used to take care of patients in~     intensive care units, etc... Sepsis and septic shock are the most prevalent illnesses which~     cause the highest mortality in intensive care units.~      The incidence of this illness is 500,000 / year in the USA, and 240-400 / 100,000 persons in~     Europe. So this is a subject of great interest in hospitals and also to the National Health~     System (to both health workers and the health authorities) as a lot of money is spent on~     this illness.~      Since the 19th century, ultraviolet rays have been known to be able to sterilize~     microorganisms (to kill them); yet no ultraviolet system machine has been on the market,~     until now, to control nosocomial infections.~      The Medixair system, which aims to do this, has recently come on to the market. It uses~     C-ultraviolet rays, which are the strongest kind of ultraviolet rays to kill microorganisms.~      Thus, it is of interest to know whether this system is good enough to lower infections in~     intensive care units. It is logical to believe that the the fewer the micro-organisms, the~     lower the possibilities of infection.~   "
43095|NCT02492906|"~     Due to scarce published articles about this subject, the researchers aim to study the volume~     measurements of the brain cortex of patients with primary severe knee osteoarthrosis and~     those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating~     the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and~     pressure pain threshold.~   "
43096|NCT02492893|"~     People with HIV and a substance use disorder who are reentering the community from prison or~     jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy~     (ART) medication. This mixed-methods randomized controlled trial will compare the stress,~     substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly~     yoga group intervention with participants in a treatment as usual control group. All~     participants are re-entering the community, have HIV and experience substance use~     challenges.~   "
43097|NCT02492880|"~     This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study~     to characterize the effects of programming features of the Boston Scientific Precision~     Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.~   "
43098|NCT02492867|"~     This is a pilot study to improve local tumor control while maintaining the same rate of~     treatment toxicity by adapting therapy to the uninvolved lung and esophagus while continuing~     to adapt therapy to the tumor for patients with Stage II/III NSCLC.~   "
43116|NCT02492633|"~     The primary objective of this project is to evaluate the effectiveness of an enhanced~     intervention vs. a standard intervention to complement a comprehensive smoke-free policy, in~     a multi-site, privately managed affordable housing context.~   "
46061|NCT02454088|"~     This will be a single-center, investigator-initiated, double-blinded, randomized,~     bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without~     Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.~   "
43099|NCT02492854|"~     The objective of this study is to compare the effectiveness of standard moist dressings and~     PICO single-use negative pressure dressings in post-operative lower extremity bypass~     patients. This study will compare the dressings' ability to decrease swelling, decrease~     post-operative infection, and improve mobility and quality of life measures.~      Subjects will be asked to participate in this study because they will undergo a lower~     extremity bypass using the ipsilateral great saphenous vein. Subjects will then be~     randomized to two post-operative treatment groups. One group will receive standard sterile~     gauze and the other will receive PICO single-use negative pressure dressings. Both groups~     will be assessed for study measures in follow-up visits as clinically indicated up to 1 year~     with the 30 day timepoint as the primary outcome for study measures.~   "
43100|NCT02492841|"~     Background: Dental caries is considered an oral health problem worldwide. In Chile the last~     national epidemiological study (2007) showed a national prevalence of dental caries in~     children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy,~     keeps the vitality of the tooth using some inductive materials mineralized tissue formation.~      Objective: The main objective of this study is to evaluate the effectiveness of two~     innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in~     the maintenance of pulp vitality in teeth permanent molars.~   "
43101|NCT02492828|"~     This will be a retrospective cohort study using national register linkage data (including~     prescription, inpatient, mortality, and socioeconomic data). The study period will be from~     May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index~     date) until their death, exiting the database, or until the end of the study period (June~     30, 2015).~   "
43102|NCT02492815|"~     Observational study to evaluate the effectiveness and safety of ipilimumab, administered~     during the European expanded access programme (EAP) in pretreated patients with advanced~     (unresectable or metastatic) melanoma.~   "
43103|NCT02492802|"~     Posaconazole plasma concentration and inflammatory markers will be determined in all samples~     available from routine analysis.~   "
43104|NCT02492789|"~     This is an open-label, multicenter, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The~     trial will enroll subjects with advanced solid tumor who have failed current standard~     anti-tumor therapies.~   "
43105|NCT02492776|"~     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two~     AF-219 formulations; to assess the effect of omeprazole on the multiple dose PK of two~     AF-219 formulations; and, to assess the safety and tolerability of AF-219.~   "
43106|NCT02492763|"~     This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide;~     Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes~     mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000~     mg/day).~      The trial will include a 1-week screening period; an 8-week antihyperglycemic agent (AHA)~     washout period, if required; a 14-week blinded therapy period (which includes single-blind~     run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last~     dose of investigational product.~      The primary hypotheses of the trial are to assess the hemoglobin A1c (HbA1C)-lowering~     efficacy of the addition of MK-8521 relative to placebo and to evaluate safety and~     tolerability of MK-8521.~   "
43107|NCT02492750|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     anakinra when given together with lenalidomide and dexamethasone in treating patients with~     early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may~     stimulate or suppress the immune system in different ways and stop cancer cells from~     growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone~     are more effective with or without anakinra in treating patients with multiple myeloma.~   "
43108|NCT02492737|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that~     harbor an IDH1 and/or IDH2 mutation~   "
43109|NCT02492724|"~     Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who~     suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be~     enrolled into the study. An 18-month recruitment period is planned with a 4-year~     postoperative follow-up period for each subject. Thus, it is anticipated that the study will~     require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively,~     prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years~     postoperatively from the date of surgery.~   "
43110|NCT02492711|"~     The purpose of this study is to determine whether patients treated with margetuximab plus~     chemotherapy have longer progression free survival and overall survival than patients~     treated with trastuzumab plus chemotherapy.~   "
43111|NCT02492698|"~     The objective was to evaluate the effect of the consumption of dual probiotic strains~     containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L.~     plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including~     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.~   "
43112|NCT02492685|"~     The investigators' study is a prospective study to evaluate the enhancement pattern of~     contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential~     diagnosis between gallbladder polyps by using software program of quantitative analysis.~   "
43113|NCT02492672|"~     The current registry is being undertaken to assess the long-term (12 month) safety and~     tolerability of Venofer in the pediatric population with chronic kidney disease that~     requires intravenous iron maintenance therapy.~   "
43114|NCT02492659|"~     Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser~     assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced~     phacoemulsification power and time, and comparable refractive outcome in clinic.~      It is still unknown whether there are toxic substances produced due to photochemical or~     high-energy physical effect of femtosecond laser during FLACS.~   "
43115|NCT02492646|"~     The purpose of this study is to evaluate the influence of none-lubricated dry tube on the~     incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal~     intubation.~   "
43117|NCT02492620|"~     It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during~     the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will~     result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P,~     FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The~     investigators further hypothesize that effective treatment of anemia and mineral metabolism~     with FC in the pre-dialysis and transition period will result in improved physical~     functioning, reduced hospitalization and reduced total cost of care when compared to~     participants receiving contemporaneously provided standard of care therapy.~   "
43118|NCT02492607|"~     A substantial number of DCIS lesions will never form a health hazard, particularly if it~     concerns slow-growing low-grade DCIS. This implies that many women might be unnecessarily~     going through intensive treatment resulting in a decrease in quality of life and an increase~     in health care costs, without any survival benefit.~      The LORD (LOw Risk DCIS) study is a randomized, international, multicenter, phase III~     non-inferiority trial, and aims to determine whether screen-detected low-grade DCIS can~     safely be managed by an active surveillance strategy or that the conventional treatment,~     being either WLE alone, WLE + RT, or mastectomy, and possibly HT, should remain the standard~     of care.~   "
43119|NCT02492594|"~     Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for~     diagnostics designed to permit timely onset of appropriate treatment. The aim of the current~     clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of~     IFI, is to test newly developed diagnostic approaches to invasive fungal infections in~     relation to established procedures. The studies will be performed in a prospective, blinded~     fashion, and represent a work package within the FUNGITECT grant supported by the European~     Commission. The studies will focus on analyses of blood-samples from patients with febrile~     neutropenia during treatment of acute leukemia or after hematopoietic stem cell~     transplantation.~   "
43120|NCT02492581|"~     USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up,~     performed using a random sample of prescribers. The aim of the study is to evaluate the use~     of Selincro in real-life and its impact on alcohol consumption at one year.~   "
43121|NCT02492568|"~     To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm~     compared to the pembrolizumab after SBRT arm at 12 weeks~   "
43122|NCT02492555|"~     The purpose of this study is to determine if the IBD patient doing home monitoring by web~     app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with~     patients doing home monitoring scheduled interval combined with on demand(SI+OD) ( every~     3.month).~      Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow~     up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of~     relapse, and thus help change the naturel course of disease? Will home monitoring of DA and~     FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of~     the disease, hospitalizations and number of hospitalization days, required surgery and~     outpatient visits? Is there a difference in patients' compliance with treatment plan between~     OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?~   "
43123|NCT02492542|"~     The purpose of this study is to investigate the effect of electric stimulation on the pelvic~     floor function in cervical cancer patients with type III hysterectomy.~   "
43124|NCT02492529|"~     Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging~     study.~   "
43125|NCT02492516|"~     Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and~     lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only~     therapeutic option now. Recently several studies have shown that stem cell transplantation~     is safe and can be effective in reduction of disease progression and increase of quality of~     life.~   "
43126|NCT02492503|"~     Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent~     cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic~     equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian~     cancer, performed in a cervix cancer population.~   "
43127|NCT02492490|"~     The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF)~     derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from~     Donation after Citizen Death (DCD) can effectively reduce the need for post transplant~     immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF~     derived MSC to the recipients during and after operation to assess the effect of SVF derived~     MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and~     graft survival. 120 patients eligible for the study as described below will be enrolled,~     with 60 patients in intervention group and 60 in control group.~   "
43128|NCT02492477|"~     The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer~     patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The~     manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical~     practice, the intervals are usually at least three months. Regular flushing might lead to a~     decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or~     thrombosis rate and patients discomfort. Therefore, this study investigates the safety of~     not flushing the PORT-A-CATH® for 6 or 12 months.~   "
43129|NCT02492464|"~     This will be a double-blind randomized clinical trial carried out on subjects with~     suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with~     a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order~     to evaluate the middle-term effects on vascular health evaluated by non invasive methods~     (Vicorder(R) apparatus)~   "
43130|NCT02492451|"~     The investigators will try to assess the effect of endometrial injury preceding the~     intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase~     support and the control group.~   "
43131|NCT02492438|"~     To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine)~     vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in~     patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or~     are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after~     4 and 52 weeks.~   "
43132|NCT02492425|"~     The purpose of this study is to evaluate the disease burden of hospitalized patients with~     CAP and HCAP in real life of China~   "
43135|NCT02492386|"~     In this prospective, unblinded, single-arm, single-center study, investigators would like to~     assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients~     with erectile dysfunction and concomitant internal pudendal artery stenoses. A total of 15~     bioabsorbable vascular scaffolds (BVSs) are planned to be assessed and will be deployed in~     the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments.~   "
43136|NCT02492373|"~     To investigate the benefit of the application of topical high potency steroid on the~     incidence of post inflammatory hyperpigmentation after laser treatment.~   "
43137|NCT02492360|"~     This study targets patients with cisplatin-induced peripheral neuropathy and will allow us~     to: a) study peripheral neuropathy in diverse human sensory neurons in ways that were not~     possible previously; b) gain insight on druggable targets to treat or prevent this~     devastating side effect of chemotherapy; c) provide a human cellular model that can be used~     for screening of drugs to determine if they are neurotoxic. The combination of patient~     information and in vitro measurements provides a highly relevant and clinically useful model~     for studies aimed to impact treatment selection for the individual cancer patient.~   "
43138|NCT02492347|"~     Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of antidepressants that suppress~     the re-absorption of a chemical called Serotonin in the brain, and improve mood. SSRI use in~     the treatment of mental health problems has increased greatly since their introduction in~     the 1980's. When given in pregnancy they cause less fetal effects than other~     antidepressants. However they are still known to cause premature birth, heart defects and~     withdrawal symptoms in the baby. Withdrawal symptoms can occur in up to 30% of exposed~     babies, where as heart defects have been found to increase by 2-3 times against the normal~     rate of 1%. There is very limited information available, but it is also thought it may cause~     lengthening of a certain portion of the heart beat, the QT interval, which has been shown to~     lead to sudden death in adults. The QT interval will be looked at in this study, comparing~     babies exposed to SSRIs in pregnancy with unexposed babies.~      The study will be based in the United Kingdom (UK), at the Maternity Unit of a District~     General Hospital, and will be carried out over 12-18 months.~      A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram~     (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did~     not, but whose babies were still in hospital because they were at risk of having an~     infection, but were found to be healthy.~      The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening~     of the QT interval and if so, extra surveillance may be considered for this group of babies.~   "
43139|NCT02492334|"~     The study will test the efficacy of doxazosin, a long-acting and selective alpha-1~     adrenergic antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol~     use severity.~   "
43140|NCT02492321|"~     This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel~     group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to~     vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to~     severe allergic conjunctivitis (AC) three times daily for 4 weeks.~      Approximately 250 subjects at approximately 8 centers in the US will be screened and~     enrolled into the study.~   "
43141|NCT02492308|"~     The objective of this trial is to determine if autologous SVF derived MSC can effectively~     reduce the need for post transplant immunosuppressant in living-relative kidney~     transplantation. 120 patients eligible for the study as described below will be enrolled,~     with 60 patients in intervention group and 60 in control group.~   "
43142|NCT02492295|"~     Migraine headache is a frequent Emergency Department complaint. While first-line Emergency~     Department treatment for this condition is well-established, optimal second-line treatment~     options are not well-defined. First line Emergency Department treatments include~     Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), dopamine antagonists. Second line treatments~     that have been proposed include triptans, steroids, antiepileptics, benzodiazepines,~     magnesium and narcotics, but none have shown reliable Emergency Department efficacy (less~     than 50% in most studies). In the past ten years there have been several case series~     published on using low, sub-anesthetic doses of propofol for the treatment of refractory~     migraine. These case series have reported very impressive efficacy rates, especially in~     comparison to the published efficacy rates of other second-line treatments. Personal~     experience using this treatment modality has also yielded impressive clinical results. Most~     of the published series, however, have not been conducted in the Emergency Department.~      The Investigators propose to conduct a prospective, observational trial of low-dose propofol~     for the treatment of refractory migraine in the Emergency Department. Propofol is a~     frequently-used Emergency Department sedative, with a good safety profile when administered~     by experienced Emergency Medicine practitioners using appropriate monitoring. The primary~     outcome measurement will be reduction of pain after treatment, with secondary outcome~     measures related to the safety of treatment and continuation of pain relief after leaving~     the Emergency Department. Although the protocol will involve the use of low-dose propofol~     with the aim of achieving light-to-moderate sedation only, all patients will care for and~     monitor at a level appropriate for deep procedural sedation.~   "
43143|NCT02492282|"~     Closed loop system in intravenous anesthesia is more effective to maintain depth of~     anesthesia compared with manual system open, it is unclear what driver and variables to~     achieve this goal be more physiological; in the literature doesn´t exist studies showing~     that the closed-loop system for both hypnotic and opioid is better than the controlled~     pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain~     anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in~     closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for~     propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was~     integrated an additional closed system for remifentanil using hemodynamic variables and~     control algorithm associated with bispectral index.~      The purpose of this study is to determine the therapeutic effectiveness of a new system of~     administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia~     compared to an open loop system TCI.~   "
43239|NCT02491034|"~     The purpose of this project is to implement a Depression Education Intervention (DEI)~     designed to increase disease literacy, and dispel myths about depression and its treatment~     among Hispanic patients thus reducing stigma and increasing treatment engagement. This~     project will be conducted at one community health center whose patient population is~     majority Hispanic.~   "
43144|NCT02492269|"~     The overall goal of this project is to determine the role of anesthetic management in~     children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early~     extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress~     response as would be evident by the stress markers levels and the level of two cerebral~     injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative~     outcome and hopefully improve both the short and the long term neurodevelopmental outcome in~     these children. The project is prospective, randomized and blinded study. The first and~     second aim of the study should be conducted over 2 year period. Our long term aim will be~     concluded when these children reach the school age.~   "
43145|NCT02492256|"~     Although circumferential pulmonary vein isolation (PVI) has been considered as the~     cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate.~     The investigators designed a prospectively randomized study to evaluate whether additional~     atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical~     outcome in patients with persistent AF.~   "
43146|NCT02492243|"~     The trial will inform whether detection of ventricular arrhythmias by means of implantable~     loop recorder (ILR) can help to predict SCD in the large population of survivors of a~     myocardial infarction with preserved left ventricular function, EF>40%. This may improve~     risk stratification in these patients, and can inform on the clinical use of subcutaneous~     monitors to identify post-infarction populations in need for an intervention to prevent~     sudden death.~   "
43147|NCT02492230|"~     The objective of Left atrial appendage closure compared to standard antiplatelet therapy in~     patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to~     evaluate the safety and efficacy of implantation of left atrial appendage closure compared~     to standard antiplatelet therapy for prevention of thromboembolic events and stent~     thrombosis in subjects with AF who underwent PCI.~   "
43148|NCT02492217|"~     To identify new candidate genes and proteins that are differentially expressed in~     responders' vs non-responders to anti-TNF alpha therapy at the several time points the~     investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between~     gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.~   "
43149|NCT02492204|"~     The main objective is the study of the role of IL33/ST2 axis in the pathogenesis of ARDS,~     it´s value as prognosis marker and as therapeutic target.~   "
43150|NCT02492191|"~     Introduction Day surgery is a well-established practice in many European countries, but only~     limited information is available regarding postoperative recovery at home though there is a~     current lack of a standard procedure regarding postoperative follow-up. Furthermore, there~     is also a need for improvement of modern technology in assessing patient related outcomes~     such as native software applications. This article describes the RAPP study protocol, a~     mixed-methods study to evaluate if a systematic e-assessment follow-up in patients~     undergoing day surgery is cost effective and improves postoperative recovery, health and~     quality of life.~      Methods and analysis This study is a mixed-methods study design that includes a multicenter,~     two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative~     interview studies. One thousand patients >17 years of age who are undergoing day surgery~     will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14~     days measured via smartphone app including the Swedish web-version of Quality of Recovery~     (SwQoR) or to standard care (i.e. no follow up). The primary aim is cost effectiveness.~     Secondary aims are improvements on postoperative recovery, health-related quality of life~     (QoL) and overall health; (b) to determine whether differences in health literacy have a~     substantial and distinct effect on postoperative recovery, health, and QoL; and (c) to~     describe day-care patient and staff experiences with a systematic e-assessment follow-up~     after day surgery.The primary will be measured at 2 weeks postoperatively and secondary~     outcomes b) at 1 and 2 weeks and c) at 1 and 4 months.~   "
43151|NCT02492178|"~     The study aims at describing the pharmacokinetic properties of rectal artesunate in well~     characterized severely ill patients using intravenous artesunate as a comparator.~   "
43152|NCT02492165|"~     The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult~     and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity,~     reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data~     from other Asian pediatric populations.~      Primary objective:~      - To describe the safety profile of a single dose of IMOJEV®.~      Secondary objectives:~        -  To evaluate the immune response to JE 28 days after the administration of a single dose~          of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.~   "
43153|NCT02492152|"~     The purpose of the study is to see whether the use of DIANATAL during active labor, reduces~     the rates of episiotomy and vaginal tears.~   "
43154|NCT02492139|"~     The overall purpose of this study is to evaluate the reliability and usability of the~     reusable BrownieForSymphony pump set in home use.~      The primary objectives of this study is to asses and compare the System Usability Scale~     (SUS) score of the BrownieForSymphony pump set and the current used Symphony pump set.~      Secondary Objectives~      The secondary objectives of this study are:~      to evaluate the rate of usability problems with the BrownieForSymphony pump set~        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump~          set~        -  to evaluate perceived comfort during pumping with the BrownieForSymphony pump set~          Prospective Cohort Study (quasi Cross over design)~   "
43155|NCT02492126|"~     To determine whether contraction abnormalities in the esophagus plays a role in~     gastroesophageal reflux induced cough, and thus cough severity in patients with chronic~     cough.~   "
43156|NCT02492113|"~     The main purpose of this study is to define at the bedside the Titrated-PEEP level for~     obese patients that increases the likelihood of extubation and ventilator liberation.~      The investigators hypothesized that a titrated level of PEEP (Titrated-PEEP) during SBT~     will keep the lung recruited, maintain oxygenation, and decrease the work of breathing~     resulting in successful ventilator liberation. In addition, post-extubation the~     investigators hypothesize that these patients will require noninvasive ventilatory support~     in the form of CPAP at the level of titrated-PEEP used during the SBT.~   "
46062|NCT02454075|"~     This study will evaluate whether treatment with YF476 is safe and effective in reducing the~     size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL~     cells, in patients with Zollinger-Ellison syndrome.~   "
43159|NCT02492074|"~     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of~     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on~     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal~     processing, and neural oscillations. In addition the effects of the phytocannabinoids on~     lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by~     fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.~   "
43160|NCT02492061|"~     This study aims at assessing the effect of a demand-creation intervention on couples' HIV~     counseling and testing (couples' HCT) uptake among married couples who have never tested~     together as a couple. The study is being implemented in 12 clusters; six intervention and~     six comparison clusters. A total of 1,538 couples will be enrolled into the study; 769~     couples per arm. Couples in the intervention communities are invited to participate in small~     group, couple-focused or men-only, interactive sessions lasting 3-4 hours in which the~     advantages and fears associated with couples' HCT are discussed with invited couples to~     motivate them to consider testing together as a couple. The meetings are reinforced with~     testimonies from previously tested couples. At the end of the sessions, couples or men~     receive invitation coupons which they present to a designated health facility to receive~     couples' HCT services (couples are free to receive individual HCT or not to honor the~     invitation, if they are not interested in taking the HCT offer). In the comparison~     communities, standard of care health education activities including general adult community~     sessions are held but couples do not receive any invitations to test as a couple.~     Nevertheless, couples in the comparison communities have unlimited access to HIV counseling~     and testing services that are offered by the Rakai Health Sciences Program within the study~     communities. The investigators hypothesize that couples in the intervention arm will be more~     likely to test together than those in the comparison arm. The study objectives include: a)~     exploring the motivations for and barriers to couples' HCT uptake; b) assessing the effect~     of a demand-creation intervention on couples' HCT uptake among married couples with no prior~     couples' HCT experience, and c) exploring the effect of couples' HCT vs. individual HCT on~     linkage to and retention in HIV care.~   "
43161|NCT02492048|"~     This is multi-center prospective, longitudinal case series with comparison to historical~     controls.~   "
43162|NCT02492035|"~     The Canadian hypertension education program recommends increased physical activity, adoption~     of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and~     alcohol intake for treatment and prevention of hypertension. Objective: To describe patients~     participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a~     family medicine primary care setting. Design: Descriptive study. Participants: The study~     aims to recruit 60 sedentary hypertensive patients to participate in a 6-month~     randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary~     (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood~     pressure measurements [ABPM]), non-smoker, non-diabetic and without dyslipidemia.~     Intervention: Patients are recruited by health care professionals of the family medicine~     unit and are thereafter randomized to one of four intervention groups: 1) standard medical~     care (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet~     and physical activity. Patients are evaluated (pre, mid and post intervention), monitored,~     and educated by the interdisciplinary health care team that includes a physician, a~     kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and~     descriptive statistics were used to analyse data. This study will document the efficacy of a~     primary care lifestyle intervention program on cardiometabolic and hypertension risk~     factors.~   "
43163|NCT02492022|"~     Quitting smoking is a big decision, a decision to achieve better health. Trying to quit~     smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure~     to change the routine, can also be sources of stress.~      Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability,~     hunger and cravings for more tobacco. Nicotine creates a dependency so that the body~     develops a need for a certain level of nicotine at all times. Unless that level is~     maintained symptoms of withdrawal appear.~      For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and~     stressful, but they are temporary.~      Research has demonstrated the relative effectiveness of pharmacotherapy treatments in~     smoking cessation but no studies have examined the effects of the probiotics on the~     withdrawal symptoms associated with the tobacco cessation during nicotine replacement~     therapy (NRT).~      The purpose of this study is to assess the effectiveness of two probiotic products during~     NRT for managing withdrawal symptoms associated with smoking cessation.~   "
43164|NCT02492009|"~     The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient~     decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is~     to establish the feasibility of future large international RCT of the PDA's effectiveness.~   "
43165|NCT02491996|"~     The investigators proposed a desire satisfaction-targeted intervention for disordered~     gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is~     based on the weak self-control relative to growing desire to gamble. This intervention model~     perceives loss of gambling control as a failure of strategy in which gambling is anticipated~     to fulfill various desires (i.e., desires for fame, money, and escapism). Therefore, the~     alternative behaviors to fulfill original desires directly become the main therapeutic~     purpose.~      Materials and Methods: Outpatients who were primarily diagnosed as gambling disorder by the~     DSM-V were treated by DTIG. This method usually comprised 1 or 2 sessions, 60 minutes in~     duration, delivered by a psychiatrist. Participants were examined : 1) Basic background such~     as gender, age,; 2) medical variables such as the onset age, the duration of the problem~     gambling, psychiatric complications, motivation to quit gambling; 3) assessment of severity~     (DSM-5, SOGS and G-SAS); 4) Short prognosis; 6 months-outcome after intervention (problem~     gambling/ control gambling/ abstinence).~   "
43166|NCT02491983|"~     This is an international, randomized, open-label, controlled, multicenter phase II clinical~     trial to investigate and compare the safety and efficacy of palbociclib combined with~     fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast~     cancer.~   "
43167|NCT02491970|"~     The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol~     (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the~     Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA~     concomitant treatment.~   "
43190|NCT02491671|"~     The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung~     resection procedures remains unproved. The investigators hypothesize that one of the main~     reasons for that is the heterogeneity of previously studied populations. Since currently the~     risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research~     is to investigate the effect of routine application of a novel tissue sealant in patients~     selected on the basis of a high risk of PAL estimated before surgery.~   "
47632|NCT02433587|"~     The primary objective of the trial is to evaluate short versus long duration dual~     antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.~   "
43168|NCT02491957|"~     The purpose of this study is to evaluate the safety and feasibility of LOFT Therapy in~     breast cancer survivors. In a previous study, the investigators found that many patients are~     more debilitated at diagnosis than previously recognized. Both chemotherapy and~     anti-estrogen therapy have a large effect. Within 6 months patients replace muscle with fat~     leading to a significant reduction in muscle power and endurance. Our data suggests that~     common exercise recommendations for at least 150 minutes of exercise a week would be far~     beyond many of our patients' physical ability after therapy, leading to the soreness,~     injury, frustration, and early discontinuation (or failure to initiate an exercise program~     in the first place). The degree of muscle loss seen in our patients is similar to that~     documented in US astronauts after long-term space flight. Our collaborator Dr. Yvonne Cagle,~     retired USAF flight surgeon, noted that the cosmonauts were in better shape (had less muscle~     atrophy) than the astronauts. This difference was more than could be explained by the~     rigorous Russian exercise program. The only key distinction was the compressive, penguin~     suits used by the Russians. This observation lead Dr. Cagle to develop a technique called~     low intensity, off loaded-compressive therapy (LOFT) to replicate the impact of the Russian~     penguin suits for patients who were debilitated, whether by space flight or by chronic~     conditions such as arthritis, Parkinson's disease, and multiple sclerosis. The LOFT method~     does not require excessive exertion or strain on the joints. In field observations, LOFT~     therapy improved muscle strength, muscle mass, endurance, sleep quality, and fatigue. This~     pilot study is the first to evaluate the safety, feasibility, and biologic impact of LOFT on~     breast cancer survivors.~   "
43169|NCT02491944|"~     The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall~     cell lung cancer. Lung cancer has been the most common cancer in the world for several~     decades and represents 12.8% of all new cancer cases in 2008.~      The purpose of this study is to see how much AZD9291 is taken up by the body when dosed by~     mouth (tablet) compared to when the study drug is dosed once by injection directly into the~     vein (intravenously). The dose given directly into the vein will be radiolabelled. This~     means that the test drug has a radioactive component which helps us to track where the drug~     is in the body. This allows us to detect the differences between the tablet and the~     intravenous dose.~      The study will be performed in 12 healthy male subjects aged 18-65 years. On Day 1, subjects~     will be dosed with a single oral dose of 80 milligrams AZD9291 tablet followed by 100~     micrograms [14C] AZD9291 dosed as an intravenous microdose beginning 5 hours and 45 minutes~     after the oral dose has been administered. Subjects will remain in the study centre until~     after the 120 hour post-dose blood sample is obtained and will return to the clinic for~     further visits on Day 8, 10, 15 and 22 for pharmacokinetic and safety assessments.~   "
43170|NCT02491931|"~     Introduction: Glutamine (GLN) is the most abundant free amino acid in the body. It modulates~     immune cell function and is an important energy substrate for most cells (especially for~     enterocytes and lymphocytes) in critical patients. GLN levels significantly decreased during~     sepsis/critical illness leading to an increase in infectious complications, organ failure~     and mortality. Moreover, in cases of ischemia/reperfusion injury in the myocardium, GLN~     increases the levels of Adenosine triphosphate (ATP)/Adenosine diphosphate (ADP) ratio and~     prevents intracellular lactate accumulation. Recently, the perioperative effect of~     intravenous and oral GLN treatment been associated in lowering levels of cardiac injury~     markers such as Troponin-I (TROP-I) and the number of postoperative complications in~     patients who underwent Cardiopulmonary Bypass (CPB). The aim of the study was to analyze the~     oral dose of preoperative oral GLN treatment in patients who underwent CPB with~     extracorporeal circulation in Mexican patients.~   "
43171|NCT02491918|"~     This prospective, randomized, clinical trial looks to compare children undergoing congenital~     cataract surgery with intraocular lens (IOL) implantation in terms of visual axis~     obscuration as well as postoperative complications such as glaucoma, inflammation and IOL~     centration when IOL fixation is performed using two different techniques : 1) conventional~     in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the~     IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children~     randomized to receiving IOL implantation using one of the two techniques will be followed up~     until 12 months postoperatively.~   "
43172|NCT02491905|"~     This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in~     non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low~     dose, high dose, and placebo control group.~   "
43173|NCT02491892|"~     This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants~     with metastatic breast cancer which has progressed during or after standard chemotherapy and~     which is not amenable to curative therapy. Those who are maintaining a response to therapy~     or who have stable disease at the end of the formal study period will continue treatment~     until disease progression or unacceptable toxicity. Approximately 120 participants will be~     enrolled.~   "
43174|NCT02491879|"~     This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented~     with mechanical low-back pain to the emergency department.~   "
43175|NCT02491866|"~     Objectives~        1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived~          quality of care in Psychiatry.~        2. to analyze the implementation of this new measure in clinical practice : qualitative~          analysis of the relationship patient/professional.~   "
43176|NCT02491853|"~     This is a prospective observational multi-center multi-national study of the characteristics~     and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab~     Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical~     characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as~     mortality and ICD discharges over 1 year of follow-up will be collected.~   "
43191|NCT02491658|"~     The purpose of this study is to investigate the safety and efficacy of umbilical cord~     derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis~     vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients~     will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life~     Quality Index (DLQI) in the baseline and after MSCs infusions.~   "
43441|NCT02488382|"~     The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a~     pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing~     sufficient number of stem cells for autologous stem cell transplantation in patients with~     lymphoma and multiple myeloma.~   "
43177|NCT02491840|"~     Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with~     disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not~     respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay~     their surgical management. The completion of chemotherapy for these patients would be a bad~     prognosis factor according to recent data from the literature. Therefore, the aim of this~     research is to find prognostic markers of sensitivity to chemotherapy usually performed. The~     investigators are going to use biopsies realized at diagnosis and select patients good and~     bad responders.~      Primary purpose:~      To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative~     chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation~      Secondary purposes:~        -  To assess the impact of patients' lifestyle (via a questionnaire) on the response to~          chemotherapy~        -  To study markers of cancer stem cells~        -  To correlate clinical and molecular markers with patient survival and quality of life~          questionnaires~        -  To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in~          frequently deregulated genes in gastric cancers.~        -  To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73,~          HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.~        -  To correlate the abnormalities found in the with tumor stages (before and after~          chemotherapy) and with 5 years overall survival and progression-free patients~   "
43178|NCT02491827|"~     Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE,~     also named 'optical biopsy') might improve the results of medically necessary neurosurgery~     to prove practicability, safety and harmlessness of CLE during neurosurgical procedures~   "
43179|NCT02491814|"~     This study investigates the effects of commercially-available dairy (1% cow's milk and~     yogurt beverage) and non-dairy alternatives (almond and soy beverages) on satiety and~     post-meal blood glucose. Each participant will receive every treatment in this crossover~     design study.~   "
43180|NCT02491801|"~     The proposed study is planned to determine the potential role for regular fat dairy products~     in short-term metabolic control in younger and older adults and the metabolic flexibility in~     response to food components, which are areas that have not yet been explored. Subjects would~     be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim~     milk (control) and water (non-caloric control), 2 hours before consumption of ad libitum~     pizza meal in 5 consecutive sessions.~   "
43181|NCT02491788|"~     The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting~     drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working~     overnight shifts will significantly improve both objective (total sleep time, sleep~     efficiency, wake after sleep onset) and subjective (sleep quality) measures of daytime~     sleep.~   "
43182|NCT02491775|"~     The investigators propose to conduct a pilot feasibility study of single agent afatinib in~     patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant~     adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of~     characterizing the genomic landscape before afatinib and at the time of disease progression.~   "
43183|NCT02491762|"~     This study evaluates the effect of breast reconstruction surgery on respiratory functions.~     45 patients elected for unilateral or bilateral breast reconstruction surgery will go~     through respiratory function examinations a month prior to the surgery, one month after~     surgery and three months after surgery.~   "
43184|NCT02491749|"~     Ultra-fast track anaesthesia (UFTA) aims at immediate extubation of cardiac surgical~     patients at the end of the operation. This study compares the effect of UFTA versus~     continued postoperative mechanical ventilation on the ICU length of stay (LOS).~      Methods. Fifty two elective adult patients were randomly allocated into UFTA and~     conventional groups by computer-generated random numbers. Redo operations, pre-operative~     intubation, uncontrolled diabetes, shock/LVEF <45%, PASP >55mmHg, creatinine clearance <50~     ml min-1, haemodynamic instability, or those with concerns of postoperative bleeding were~     excluded. Pre- and intra-operative management was similar and Logistic EuroSCORE II was~     calculated for all. Intra-operatively, haemodynamic parameters, urine output, SPO2, arterial~     blood gas analysis (ABG), 5-lead ECG, operative- bypass- and cross clamp time, and opioid~     consumption were collected.~      Postoperatively, patients were compared during their ICU stay. Data were analysed by~     χ²/Fischer exact, unpaired student's t-test, univariate two-group repeated measures ANOVA~     with post hoc Dunnett's test, and Mann-Whitney U tests as appropriate. p<0.05 was considered~     significant.~   "
43185|NCT02491736|"~     The aim of this study is to analyse the effect of ketoprofen gel in children presented with~     ankle sprain to the emergency department.~   "
43186|NCT02491723|"~     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence~     against viral and bacterial stimuli by modulating the immune response. The aim of this study~     was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate~     whether macrolide attenuate its levels.~   "
43187|NCT02491710|"~     Training is of great importance in laparoscopy. There are different commercially available~     trainers which are quite expensive and are used by trainees only inside the hospital.~      The aim of this study is to find out whether basic laparoscopic skills training using an~     inexpensive tablet-based laparoscopic box trainer leads to equal training results (=~     improvement of skills) compared to practicing with a conventional commercial box trainer.~     Furthermore, trainee satisfaction with this home-made alternative compared to the standard~     trainer will be assessed.~   "
43188|NCT02491697|"~     The prognosis of advanced breast cancer does not improve much recently although varies of~     adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer~     cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its~     role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the~     efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine~     monotherapy for the treatment of advanced breast cancer.~   "
43189|NCT02491684|"~     A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent~     or reduce the severity of asthma attacks when administered to asthma patients at the onset~     of symptoms of common cold or influenza~   "
43192|NCT02491645|"~     Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory~     processing abnormalities .Tackling these problems would help in better quality of life, both~     for the parents and the children. Sensory integration therapy, an individualized clinic~     based therapy have been shown to have a positive effect on those children with sensory~     abnormalities. Hence the investigators are doing this study , to primarily look into the~     efficacy and feasibility of home based sensory interventions in autistic children with~     sensory processing abnormalities.~   "
43193|NCT02491632|"~     The goal of this clinical research study is to learn about the effects of combining physical~     activity with dexamethasone to treat fatigue in patients with advanced cancer.~   "
43194|NCT02491619|"~     The correlation between tooth inclination and bone thickness and the comparison between~     thickness measurements and buccolingual inclination before and after dental decompensation~     will be evaluated through tridimensional images in individuals with class III dentofacial~     deformities.~   "
43195|NCT02491606|"~     This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of~     WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum~     malaria in Nyanza Province, western Kenya.~   "
43196|NCT02491593|"~     The aim of this study is to compare the outcome of three (3) quantitative immunochemical~     faecal occult blood test in symptomatic patients.~   "
43197|NCT02491580|"~     Patients with previous malignancies have increasingly been accepted for renal~     transplantation. However, post-transplant malignancy risk and survival rates of these~     patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily~     high risk of post-transplant malignant tumours and if the organs as a resource are too~     limited for investment in this patient group.~   "
43198|NCT02491567|"~     Hashimoto Thyroiditis (HT) and Graves Disease (GD) are known to be caused by abnormal immune~     response against self cells and tissues. Epigenetics is a novel field of biology studying~     the mechanisms by which the environment interacts with the genotype to produce a variety of~     phenotypes through modifications to chromatin that do not directly alter the DNA sequence. A~     very limited number of epigenetic studies have been published in patients with HT and GD so~     far. Therefore, the purpose of this study is to analyze DNA methylation status in White~     Blood Cells (WBCs) within the promoter regions of genomic sites that have been previously~     identified as susceptibility loci or sites for autoimmune thyroid disease, such as the CD40,~     FOXP3, CTLA4, PTPN22, CD25, and TPO genes.~   "
43199|NCT02491554|"~     This is a monocentric, randomized, controlled, 2 arms, interventional, observer-blinded~     feasibility trial.~      Patients suffering from essential tremor (ET) will be treated with Deep Brain Stimulation~     (DBS). For the implantation of the DBS electrodes and the DBS system (Activa INS, Medtronic)~     patients will randomized either to conventional stereotactic surgery of thalamic/subthalamic~     region with short anesthesia or to MR-tractography guided stereotactic surgery with target~     point of the dentato-rubro-thalamic bundle (DRT) in general anesthesia.~      Patients will visit the study center at screening, baseline/neurosurgery, six and twelve~     months after neurosurgery.~   "
43200|NCT02491541|"~     The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study~     is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use~     in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1)~     vaccination.~   "
43201|NCT02491528|"~     This is a multicenter, randomized, open, parallel group, active-controlled study. The study~     period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24~     weeks.~   "
43202|NCT02491515|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of denosumab in Japanese patients under~     clinical practice. The participants are treated in the investigators hospital, who are under~     severe osteoporotic condition.~      The main objective of this study is to investigate effects of denosumab. The researchers~     also investigate the effects of Effects of previous osteoporotic therapy to denosumab~     treatment. In this study, the investigators analyse the determinants of subsequent BMD~     increase and fracture preventing effect by teriparatide.~   "
43203|NCT02491502|"~     This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules~     with the FastScan version using assessment of patient experience and adverse event~     reporting.~   "
43204|NCT02491489|"~     Shoulder pain is one of the most common musculoskeletal conditions treated by physical~     therapists. One common treatment is passive glenohumeral joint accessory mobilization, which~     is the application of a therapist generated force to move the humeral head (ball) on the~     glenoid (socket) of the shoulder to improve motion and decrease pain. It is generally~     accepted that these mobilizations do not elicit active muscular contractions of the~     surrounding musculature. However, there is very little literature to support this~     assumption, and a preliminary PubMed search utilizing the terms shoulder, mobilization,~     and EMG returned zero relevant references. Therefore, the investigators plan to utilize~     surface electromyography (EMG), a non-invasive assessment tool, to objectively measure the~     activity of the rotator cuff muscles (the muscles that surround the shoulder and provide~     stability to the joint) during various grades(levels of force and amplitude of movement) of~     glenohumeral mobilization ( a standard of care treatment). It is also unknown if subjects~     pain levels impact the level of rotator cuff activity. To investigate these questions, the~     investigators will collect EMG data while performing mobilizations on a total of 20~     subjects, divided into two groups: 10 pain free shoulders and 10 painful shoulders. Data~     analysis will then include descriptive analysis, estimates of effect size, and analysis for~     between group differences.~      The investigators hypothesize that there will be significant differences in muscular~     activity between groups related to the presence of shoulder pain.~   "
43205|NCT02491476|"~     The main objective of this study is to evaluate the feasibility of recording fast-ripples, a~     potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by~     Dixi-Medical.~   "
43206|NCT02491463|"~     The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity~     and immunogenicity of 2 doses of the RSV investigational vaccine, when administered~     intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.~   "
43208|NCT02491437|"~     The purpose of this randomized, two-arm and open label study is to demonstrate that the~     treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the~     daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women~     who are unable to conceive a child and are undergoing IVF. The treatment will start on the~     day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.~      Patients will be followed during treatment until 30 days after delivery to record any safety~     and tolerability data of the patient and their newborn (s).~   "
43209|NCT02491424|"~     Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of~     an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).~   "
43210|NCT02491411|"~     This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in~     treating patients with prostate cancer that has spread to other places in the body~     (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously~     treated with enzalutamide and docetaxel. Dexamethasone treatment may be able to reverse one~     resistance mechanism to enzalutamide therapy (overabundance of receptors for dexamethasone~     and other glucocorticoids inside cancer cells) and allow for renewed therapeutic sensitivity~     to enzalutamide. Androgens (a type of male hormone) can bind to androgen receptors found~     inside prostate cancer cells, which may cause the cancer cells to grow. Enzalutamide may~     stop the growth of prostate cancer cells by blocking the activity of the cancer cell~     androgen receptors. Giving dexamethasone prior to re-treatment with enzalutamide may be a~     treatment for prostate cancer.~   "
43211|NCT02491398|"~     This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone~     a first or second treatment with drugs named bendamustine and rituximab. It will observe the~     results of this treatment and evaluate its efficacy and side effects.~   "
43212|NCT02491385|"~     The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first~     gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal~     surgery.~   "
43213|NCT02491372|"~     This pilot research study aims to assess the effectiveness of an Acceptance and Commitment~     Therapy (ACT; Hayes Strosahl & Wilson, 2011) group based intervention at improving quality~     of life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer~     following curative treatment. Participants will be invited to take part in an eight week~     intervention with outcomes being measured at baseline, midpoint, post-intervention and two~     month follow up. Outcomes will be compared with a randomised control group who will receive~     treatment as usual. Research has indicated that this population are under considerable~     psychological distress however within the UK there are currently no specifically tailored~     psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan,~     Donnelly, Murray & Johnston, 2012).~   "
43214|NCT02491359|"~     This pilot phase II trial studies how well carfilzomib works in treating patients with~     chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a~     donor bone marrow or blood cell transplant, usually occurring more than three months after~     transplant, in which donor cells damage the host tissue. Carfilzomib may be an effective~     treatment for chronic graft-versus-host disease.~   "
43215|NCT02491346|"~     Poor glycemic control in critically ill patients can increase their mortality, while safe~     and efficient glucose control is laborious and time-consuming. The Space GlucoseControl~     which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose~     target range safely and effectively through regulating insulin dose rate. This study is a~     random controlled trial involving the patients with mechanical ventilation in intensive care~     unit in order to evaluate the difference of safety and efficacy of blood glucose control~     between SGC directed and conventional treatment. At last, the trial results can determine~     whether the Space GlucoseControl can control blood glucose safely and effectively in the~     patients with mechanical ventilation in intensive care units.~   "
43216|NCT02491333|"~     The objectives of this randomized controlled trial are to compare insulin sensitivity~     following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo~     metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.~   "
43217|NCT02491320|"~     This is a study protocol for a multicenter, randomized, and controlled trial. In this~     protocol, we present a randomized controlled trial comparing acupuncture pretreatment~     followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with~     anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS~     women is considered to be one of the major pathophysiological changes of PCOS, leading to~     anovulatiory infertility. A study has shown that electro-acupuncture could significantly~     improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS~     women followed by ovulation induction has not been investigated before. A total of 384~     patients enrolled in this study will be randomized into one of two groups. The treatment~     group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control~     group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate~     that acupuncture pretreatment followed by letrozole results in a higher live birth rate when~     compared with letrozole alone.~   "
43218|NCT02491307|"~     This Study will evaluate the impact of a smartphone-based platform on a range of outcomes~     for medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar)~     cared for in a large statewide community health center. The primary goal of the Study is to~     reduce emergency room (ER) visits, hospitalizations, and to look at changes in service~     utilization by using the Ginger.io platform to enhance communication between behavioral~     health providers and their patients, increasing the early detection of exacerbations in mood~     disorders (e.g. depression, anxiety, bipolar) and proactive outreach. The secondary goal is~     to improve clinical & behavioral health outcomes.~   "
43219|NCT02491294|"~     Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research,~     extension, and education project targeting 4th grade students. Its long-term goal of~     reducing the risk of childhood obesity will be addressed by promoting healthful food and~     activity environments, policies and behaviors through: 1) building and testing the efficacy~     of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an~     after-school setting to broaden its reach, and, 3) disseminating both versions through~     outreach.~   "
43220|NCT02491281|"~     This study is designed to evaluate the safety and tolerability of ascending single doses of~     LNA043 given intra-articularly into the human knee joint prior to its removal at total knee~     replacement surgery. In addition, this will help to establish the presence of LNA043 within~     the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow~     exploration of biomarkers of hyaline cartilage repair.~   "
43221|NCT02491268|"~     Epidemiological, clinicopathological and animal studies show that vascular disease in~     various forms contributes to cognitive decline. Increasing age is the strongest risk for~     dementia irrespective of whether it results from a vascular etiology or neurodegenerative~     disease processes such as in Alzheimer's disease (AD). AD and vascular cognitive impairment,~     the two most common causes of dementia, represent two extremes of a spectrum of disorders;~     however, a number of entities, which possess varying degrees of neurodegenerative and~     vascular pathologies, occur in between. The pure forms of the disorders are preferred for~     convenience to label, treat or manage but conditions within the spectrum are the norm rather~     than the exception as dementia advances. Therefore, combinatorial therapy directed at both~     vascular and neurodegenerative aspects of dementia is a promising approach for the treatment~     of dementia in the elderly.~      Cilostazol acts as an antiplatelet agent and has other pleiotropic effects based on~     phosphodiesterase-3-dependent mechanisms. Increasing evidence suggests that cilostazol~     offers endothelial protection, via pleiotropic effects. Intriguingly, cilostazol has been~     shown to decrease amyloid beta (Abeta) accumulation and protect Abeta-induced cognitive~     deficits in an experimental model. In a pilot study of 10 patients with moderate AD (mean~     MMSE score, 11.9 points) who received donepezil, cilostazol add-on treatment for 5-6 months~     demonstrated significantly increased MMSE score in comparison to baseline. Moreover,~     cilostazol was shown to be effective in preventing cognitive decline in patients with AD~     with cerebrovascular diseases, mild cognitive impairment (MCI), and mild dementia who~     received donepezil.~      These results highlight the need for a comprehensive prospective cohort study to analyze the~     effect of cilostazol on the preservation of cognitive function in patients with early-stage~     cognitive impairment, namely MCI.~   "
43222|NCT02491255|"~     The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve~     System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR)~     in symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     high or extreme risk for surgical valve replacement.~   "
43223|NCT02491242|"~     The objective of this study was to evaluate the efficacy and safety, and evolution of causes~     leading to change, of dual therapies based in Dolutegravir in patients requiring a change of~     virologically effective antiretroviral therapy.~   "
43224|NCT02491229|"~     The purpose of this study is to investigate whether a weight reduction with Hepafast in~     combination with raw food and vegetables for two weeks followed by a meal substitution with~     Hepafast and a calorie restriction in accordance with the Low Glycemic and Insulinemic~     Diet (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver~     Disease (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet~     without use of Hepafast for 12 weeks.~   "
43225|NCT02491216|"~     Acupressure has been used for thousands of years in China. Through applying pressure on the~     specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote~     relaxation and wellness, balance yin-yang and treat diseases.~      The PI has been using acupressure to treat various diseases in the clinics of the School of~     Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant~     efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid~     arthritis and various painful symptoms. When applying acupressure on the Head- Neck -~     Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of~     the patients.~      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of~     frailty increases with age. As our life expectancy increase, there will be more elderly~     suffered from frailty in the later stage of their life. Although there is still a lack of~     universally accepted clinical definition for frailty, the syndrome is now commonly~     understood as decreased reserves in multiple systems, and lowered resilience to negative~     stress. Frailty could be initiated by single or multiple conditions including malnutrition,~     chronic diseases, lack of exercise, stress and physiological or social changes caused by~     aging. Its manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional~     neuroendocrine system and a pro-inflammatory state. Frailty could affect the emotional state~     of the elderly, meanwhile, positive affect is protective against the functional and physical~     decline associated with frailty. There is limited treatment or medication for frailty. The~     investigators believe that acupressure could be a possible non invasive means to improve the~     general health conditions, including the emotional conditions of the frail elderly. In the~     past 2 years, the school of Chinese Medicine has been promoting acupressure as a health~     maintenance technique to the elderly, mostly frail elderly living in the community dwelling~     through seminars. It is in investigator's interest to run a prospective research to further~     understand the efficacy of acupressure in a wider range of frail elderly. The investigators~     would like to use a well-designed pragmatic randomized controlled trial (PRCT) to~     investigate if acupressure could help the frail elderly to improve their general quality of~     life~   "
43226|NCT02491203|"~     Stroke is a leading cause of death and long-term disability worldwide and its incidence is~     on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with~     a significant long-term impact on activities of daily living, leisure activities and work.~     The capacity for recovery following a stroke depends on several factors, including the~     extent of the initial neurological damage, spontaneous recovery and rehabilitation, with~     possible recovery even years after the stroke. Unfortunately, accessibility of much needed~     rehabilitation services poststroke often remains limited, both in terms of intensity and~     duration, as reported in a recent report on post-stroke rehabilitation services in Quebec~     (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable~     approach for upper limb training post-stroke when rehabilitation services are not available.~     Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013~     recommends home-based patient monitoring be used when frequent monitoring is needed and~     face-to-face visits are not available. Hence, The investigators have developed and propose~     to examine the use of a TR system that allows upper limb rehabilitation with ongoing~     off-line monitoring, to be used after usual poststroke rehabilitation is completed and~     services are no longer offered.~   "
43227|NCT02491190|"~     This project leverages digital health technology to support patient engagement and shared~     decision-making between families, patients, and providers. The investigators will start by~     finalizing the educational module and adding randomization for the trial (Aim 1). The~     investigators will then complete iterative user testing in the live system through~     measurement of educational module views and usability feedback interviews with 20 end users~     (Aim 2). The investigators will then conduct a randomized controlled trial to test the~     impact of the educational module on existing measures of patient engagement (Aim 3). The~     hypothesis is that parents who receive the educational module will have higher scores on~     shared decision-making, patient activation and overall patient experience.~   "
43251|NCT02490878|"~     This randomized phase II study aims to investigate whether the addition of bevacizumab to~     standard corticosteroid therapy results in greater improvement in symptoms and less~     treatment-induced symptoms compared with standard corticosteroid therapy for patients with~     symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition~     of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and~     improve neurologic impairments in patients with brain radionecrosis following radiosurgery~     for brain metastases.~   "
43228|NCT02491177|"~     This is a 2x2 factorial cluster randomized trial of two interventions to improve retention~     and adherence for women and infants on Option B+. The overall goal is to determine which~     intervention (or combination of interventions) maximizes antiretroviral therapy (ART)~     adherence and retention in care in the context of Option B+ and thus improves maternal and~     infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya~     at 20 low-resource primary health care facilities and associated communities supported by~     Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS~     Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune~     deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess~     both process and outcome indicators using a 2x2 factorial design, in which equal numbers of~     clusters will be randomized to one of the interventions (community-based mentor mothers or~     theory-based mobile text messages), both interventions, or standard of care. The~     interventions will be added to fully integrated high quality HIV and antenatal, maternal,~     neonatal, and child health (ANC/MNCH) services already offered at these sites.~   "
43229|NCT02491164|"~     Critically ill patients are often ventilated in dedicated critical care units to provide~     respiratory support. Despite best practice patients can often develop a condition called~     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their~     respiratory function, and changes on chest x-ray. The correct management for ARDS is~     identifying the underlying condition causing the deterioration and identifying appropriate~     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs~     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may~     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has~     significant mortality.~      Despite all the clinical and laboratory data at the investigators' disposal there remains~     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often~     given empirically. Therefore, there is an urgent clinical need for accurate methods to~     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As~     such, the investigating team have developed and synthesised an imaging agent called BAC TWO.~     BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can~     label gram-negative bacteria in the human lung.~   "
43230|NCT02491151|"~     Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed~     inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing~     and ineffective fluconazole trough serum concentrations were found in a recent retrospective~     study. Variability in fluconazole exposure can be easily measured with therapeutic drug~     monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug~     monitoring can be valuable regards decreasing mortality.~   "
43231|NCT02491138|"~     This study evaluates the efficacy of appearance-based interventions in promoting healthy~     sleep. One group of participants will receive standard information about sleep (control~     group), while the other group will receive information about how sleep affects their~     physical appearance (intervention group).~   "
43232|NCT02491125|"~     The study will investigate the effect of cereal based prebiotic fibres on intestinal health~     and functioning and host metabolism.~   "
43233|NCT02491112|"~     The objective of this study is to evaluate the safety and efficacy of Luliconazole Cream 1%~     when applied topically for 7 days in pediatric subjects 2 years to 17 years of age with~     tinea corporis.~   "
43234|NCT02491099|"~     Primary Objective: To assess the activity of Afatinib in patients with persistent or~     recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients~     who survive progression-free for at least 6 months after initiating therapy. Secondary~     Objectives: To assess objective response rate and durable disease control rate. To assess~     overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma~     patients.~   "
43235|NCT02491086|"~     Background About half of the daily smokers in Hong Kong have never tried and have no~     intention to quit smoking. 37.9% of daily smokers attempted to quit but failed. Nicotine~     replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal~     symptoms during early stage of tobacco abstinence and increase quit rate. However, the~     prevalence of using NRT in Hong Kong is lower than most of the developed countries. The~     proposed project aims to test if providing free NRT sampling to smokers can increase quit~     attempt and hence quit successfully.~      Methods Nurses and university undergraduate students will be trained, and will invite~     smokers at outdoor public places to participate in the randomized controlled trial, which~     randomized eligible smokers to intervention or control group. The intervention group will be~     provided with 1-week free NRT sampling and medication counselling, whereas the control group~     will only be advised to purchase NRT on their own. The primary outcome is the proportion of~     any self-reported quit attempt (no smoking for at least 24 hours) in the past month at 1-~     and 3-month telephone follow-up.~      Discussions The findings will inform the feasibility and effectiveness of delivering free~     NRT sampling to increase quit attempt and abstinence. It will yield more information on~     smokers' adherence to the NRT sampling, side effect and safety issue of the usage. Moreover,~     it will guide a future larger trial to test the effect from the NRT sampling and translation~     to practice.~   "
43236|NCT02491073|"~     The purpose of this research study is to determine if the blood tests used to measure free~     thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine~     if eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed~     so that researchers can compare different types of lab tests that measure these thyroid~     hormones. Half of the people who participate in this study will already be taking~     eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other~     half will be people who do not take eslicarbazepine acetate (Part 2).~   "
43237|NCT02491060|"~     The primary objective of this study is to compare the efficacy, safety and tolerability of~     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.~   "
43238|NCT02491047|"~     This is a prospective, multi-national, multicenter, randomized, two arms, single blind,~     Standard of Care (SOC) controlled, with blinded central reading center study. This study~     will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures~     (Gustilo IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.~   "
43252|NCT02490865|"~     The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the~     circulation.~   "
43240|NCT02491021|"~     Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic~     effect on the human body and mind. Following discharge from an ICU, patients suffer from~     varying degrees of weakness and muscle wasting. It can take many months before their~     strength returns to something like before they were ill. This weakness can have important~     consequences on an individual, affecting their ability to perform routine tasks (e.g.~     housework, shopping), and whether they can return to work or not. Not surprisingly, this~     inability to perform activities they used to do prior to their illness can have knock on~     effects on their mental well being and confidence.~      What the investigators hope to see through this study is whether or not patients can recover~     their ability to perform exercise more quickly following an ICU admission if they undergo an~     exercise-based rehabilitation programme. The investigators also hope to see whether taking~     part in a rehabilitation programme has any affect on physical and mental well being.~      The investigators hope to use a simple exercise test on a bicycle to assess subjects ability~     to exercise shortly after leaving hospital. We will then repeat the test after a period of~     physiotherapy lead rehabilitation to see if they have received any benefit from the~     programme. The investigators hope to show that by undergoing an exercise-based~     rehabilitation programme subjects will recover their ability to exercise more quickly than~     those who do not.~      By means of questionnaires the investigators hope to see what effect the rehabilitation~     programme has had on participants physical and mental well being.~   "
43241|NCT02491008|"~     Thyroid hormone is a key regulatory hormone for a range of physiological systems, including~     the skeleton. Previous studies have suggested that subclinical thyroid dysfunction (SCTD)~     may be associated with deleterious skeletal effects. However, controversy persists on the~     clinical relevance of SCTD as well as on optimal thresholds for treatment. Available data~     have substantial limitations: 1) limited prospective data are available to assess the~     associations between SCTD and non-cardiovascular outcomes, such as fractures 2) lack of data~     from large RCTs to investigate the pathophysiological mechanisms of associations between~     thyroid hormone and bone loss. The aim of the study is to examine the relationship between~     subclinical hypothyroidism and thyroid hormone replacement in regard to skeletal fragility,~     bone mineral density (BMD), bone loss and metabolism, and the risk of fractures in elderly~     participants. The listed parameters will be assessed by dual energy X ray absorptiometry~     (DXA) and novel bone imaging techniques at baseline, at 1 year of follow-up. The study will~     be nested in the TRUST trial (clinicaltrials.gov ID: NCT01660126), and will make use of its~     study infrastructure to determine bone biomarkers from biospecimens at baseline, and at 1~     year of follow-up from 145 Swiss participants with persistent subclinical hypothyroidism~     randomized to either thyroxine or placebo in Bern and Lausanne.~   "
43242|NCT02490995|"~     The purpose of the study is to measure the interest of a movie explaining the path of the~     children in surgery, in order to reduce the anxiety of the children and his parents.~      This study is interventional, method randomized, controled, open-label, comparing two~     parallel arms: anesthesist explanations versus anesthesist explanations + a movie~     explanation.~   "
43243|NCT02490982|"~     The main goal of this investigator-initiated study is to evaluate the effectiveness and~     efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS)~     patients treated in regular practice, over a period of at least two years, in the regular~     setting of a Multiple Sclerosis Clinic.~   "
43244|NCT02490969|"~     Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for~     the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute~     Coronary Syndrome (ACS) and a low-to intermediate risk profile.~   "
43245|NCT02490956|"~     The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine~     for diagnosis the patients with primary immunodeficiency disorders and study humoral and~     cellular immune response to rabies vaccine in patients with primary immunodeficiency.~   "
43246|NCT02490943|"~     Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may~     cause injection related erythema. This is a randomized controlled cross-over trial of~     superficial hot and cold modalities to reduce injection site erythema caused by PEG.~   "
43247|NCT02490930|"~     A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients~     with high grade glioma undergoing radiation and chemotherapy developed severe and persistent~     lymphopenia (CD4 counts <200 cells/mm3). This lymphopenia lasted for twelve months following~     radiation treatment and on multivariate analysis was associated with shorter survival. Our~     group has data that strongly suggests that this lymphopenia is secondary to the inadvertent~     radiation of circulating lymphocytes as they pass through the radiation beam. Investigators~     propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to~     leave the circulation prior to the initiation of radiation. It is a functional antagonist of~     the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from~     secondary lymphoid organs.~      Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and~     temozolomide and will be discontinued immediately upon completion of the six weeks of~     therapy. The primary objective is to evaluate if fingolimod can be safely combined with~     radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the~     proposed study participants. Investigators expect that patients receiving radiation and~     temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within~     four months, reference to historical control in which sustained lymphopenia lasted for~     twelve months.~   "
43248|NCT02490917|"~     The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the~     Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on~     social continence at 6 months.~      Continence is defined by the average number of pads used per day. The social continence is~     defined by (0-1) pad per day~   "
43249|NCT02490904|"~     Evaluate the impact of eplerenon (administrated during 4 days in immediate pre-operative and~     post-operative period) on graft function evaluated by the measurement of glomerular~     filtration rate at 3 months - variable strongly associated with long term graft survival.~   "
43250|NCT02490891|"~     The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT~     before and after 2 cycles of chemotherapy in patients with diffuse large B-cell lymphoma and~     a large tumoral mass~   "
43254|NCT02490839|"~     Up to now, there is few randomized, large scale study prospectively and simultaneously~     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy~     (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori~     eradication.~      The aims of this study are:~        1. to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
43255|NCT02490826|"~     The primary aim of this study is to develop software as a tool in speech and language~     therapy for the treatment of children (Portuguese and English) with phonologically based~     Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this~     approach with two groups of preschool and school aged children with phonologically based~     SSD, with one group consisting of European Portuguese (EP) speakers and one group of British~     English (BE) speakers. Performance across the two groups will be compared. The total~     duration of the project will be 30 month.~   "
43256|NCT02490813|"~     Recently, there has been an increasing interest in using traditional Chinese medicine for~     food allergy. The Harvard group has successfully demonstrated the Food Allergy Herbal~     Formula - FAHF2 completely blocked peanut-induced anaphylaxis in a murine model, and~     currently being studied in human. Therefore, in collaboration with the Institute of Chinese~     Medicine, CUHK, the investigators have developed a more simplified Chinese herbal formula -~     X (CHFX), containing four food-grade Chinese herbs, Wu-mei (Fructus Pruni Mume); Ling-zhi~     (Gonoderma); Huang-bai (Cortex Phellodendron) and Zhi-su (Perilla frutescens).~      In the present study, the investigators would like to examine whether there is reduction in~     allergic symptoms in food challenge after administering the CHFX for 8 weeks. There will be~     pre- and post- CHFX food challenges and other related tests.~   "
43257|NCT02490800|"~     First in human, open-label, sequential dose escalation and expansion study of oral BAL101553~     in adult patients with advanced solid tumors and adult patients with recurrent or~     progressive glioblastoma or high-grade glioma.~   "
43258|NCT02490787|"~     This trial is conducted globally. The aim of this trial is to investigate safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of concizumab administered subcutaneously to~     haemophilia A subjects.~   "
43259|NCT02490774|"~     Investigation of pharmacological effects, drug blood levels and safety of an intrauterine~     system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy~     young women treated for 90 days to determine the drug dose for further development~   "
43260|NCT02490761|"~     Unintentional weight loss and undernutrition are well described problems in elderly~     inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries.~     Not only are a large number of elderly patients undernourished at admission but a~     substantial proportion will lose weight and become malnourished during their hospital stay,~     putting them at increased risk of morbidity, mortality, poor clinical outcomes and prolonged~     length of hospital stay. However, as it is frequently impossible to correct undernutrition~     prior to hospital admission, every effort should be made to prevent weight loss and correct~     undernutrition during hospitalization. Therefore, screening and identification of predictors~     of patients at risk of weight loss and undernutrition at admission, and identification of~     modifiable factors (e.g. eating preferences and poor food hospital intake), where~     intervention might be helpful, are important aspects in the management of these patients.~      Before designing a food intervention study, there is a need to, firstly:~        1. describe hospital food intake, eating habits and preferences in elderly inpatients~          during hospitalization~        2. describe predictors of hospital food intake in elderly during hospitalisation~        3. compare energy and protein intake in elderly inpatients during hospitalisation with the~          United Kingdom Dietary Reference Values (DRVs)~      This study is a hospital based observational study. Eligible participants will be 125~     patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of~     Scotland. Eligible participants will be seen 96 hours after admission in order to explain~     the study process and to obtain written consent. The researcher will record basic body size~     measurements and will ask the patient questions about living conditions, feelings, memory,~     health, eating habits, opinions about the hospital food service. Nursing staff will be asked~     about patient's functional activity. The researcher will also take pictures of a subset of~     patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after~     eating. The researcher will meet each patient three times in total. The first time 4 days~     after admission; a second time, during the hospital stay and, finally, around the time of~     discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm~     circumference, grip strength and calf circumference.~   "
43261|NCT02490748|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     cervical cancer.~   "
43262|NCT02490735|"~     Chemotherapy is the main treatment method for patients with Esophageal Cancer. However,~     Relapse remains the major cause of treatment failure.Biological therapies such as CIK~     stimulate the immune system and stop tumor cells from growing. A series of studies reported~     that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators~     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy~     may kill more tumor cells. In this study, the patients will be treated with CIK cells after~     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal~     Cancer.~   "
43263|NCT02490722|"~     The aim of this study is to investigate effects of interdisciplinary group based patient~     education in patients with low back pain.~      The patients will be recruited to four group based patient education lessons during a two~     months period. The study is a randomized controlled trial and the patients will be~     randomized to standard treatment or standard treatment and patient education. The patient~     education will be led by physiotherapists, nurses and physicians. The outcomes are~     functions, pain, quality of life, self-efficacy, and depression. The data are reported in~     questionnaires.~   "
43264|NCT02490709|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal local~     excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after~     neoadjuvant chemoradiotherapy.~   "
43265|NCT02490696|"~     The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso~     in patients with non-small cell lung cancer and correlate the results of PET scans with~     immunohistochemistry.~   "
43266|NCT02490683|"~     This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or~     powder (control) on blood lipids. It will also explore the potential effects of these~     dietary supplements on inflammation markers and other biological and anthropometric~     measures. The study intervention will be 30 weeks in length. Twenty four subjects with 2 or~     more cardiometabolic risk factors will be randomized to participate in the study.~   "
43471|NCT02487992|"~     The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer~     cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for~     patients with advanced colorectal cancer.~   "
43267|NCT02490670|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours~     will pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
43268|NCT02490657|"~     The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation,~     and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled~     iloprost has been researched in animal study, but not yet in human during one-lung~     ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic~     obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air~     or PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is~     pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of~     cardiac function including Tei-index during nebulizing iloprost. The investigators~     hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic~     obstructive pulmonary disease during one-lung ventilation.~   "
43269|NCT02490644|"~     One of the most important factor that affects the post op complication of the cardiac~     surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and~     cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial~     damage and inflammatory response. These myocardial damage and inflammatory response can~     cause multi-organ failure or even death.~   "
43270|NCT02490631|"~     Surgical site infection (SSI) following spinal surgery is a frequent complication and~     results in higher morbidity, mortality and healthcare costs. SSI following adult spinal~     surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients~     and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt~     University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often~     requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The~     accurate identification of risk factors is thus important in the development of strategies~     to prevent these potentially devastating infections. This study proposes a randomized,~     controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation~     cloths for the prevention of post op surgical site infections in spine patients.~      Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect~     (decrease rates) of SSI compared to patients who receive routine standard of care (soap and~     water pre-op, day of surgery and daily post-operative).~   "
43271|NCT02490618|"~     The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in~     patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning.~     Simultaneously the additional benefit of subgingival application of probiotics via oil drops~     will be investigated.~   "
43272|NCT02490605|"~     The possible relationship between posture and instability of the masticatory muscles related~     to occlusion thus becomes the reason, the objective of this study. In this way, it will be~     possible to evaluate both postural alignment and postural balance in patients with signs and~     symptoms of temporomandibular joint disorder before and after the use of an occlusal plate.~     Our research will take place at the School of Odontology of the University of São Paulo in~     the clinics of the Occlusion and TMJ Services (SOA) and of the Envelhecer Sorrindo program,~     and the data will be collected in the Biophysics Laboratory of the School of Physical~     Education and Sports of the University of São Paulo. The population studies will be made up~     of 120 patients, 60 being part of the sample and the other 60 in the control group. All the~     patients in this study are over 20 years of age and are of both genders; the research~     criteria will be diagnosed by way of filling out the questionnaire of the RDC-TMD and~     complemented by way of diagnostic imaging via MRI of the temporomandibular joint. The study~     will be a clinical, randomized, controlled, prospective study and intervention. After the~     subjects' alignment is evaluated by way of photographs and their postural balance by way of~     a force platform, the group will the randomized; the sample group will receive an occlusal~     plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence~     of interference in the canine and anterior guides). The occlusal plate will be made from~     Vacuum Form acetate with a thickness of 1.5 mm; the simultaneous, bilateral, occlusal~     contacts and the canine and anterior guides will be obtained by way of autopolymerizable,~     acrylic resin with the mandible in a centric relationship. The occlusal plate will be~     controlled weekly. The control group will only receive orientation to do physiotherapeutic~     exercises seeking to correctly position the mandible in the resting position (maxillar teeth~     should be approximately 2 mm away from the mandibular teeth) while the tip of the tongue is~     positioned and accommodated on the roof of the mouth over the incisive papilla on the hard~     palate (without touching the teeth). The exercise will consist of repeatedly opening the~     mouth with the tongue cleaving to the roof of the mouth, 3 times per day, each period~     consisting of 3 sets with 15 repetitions. After 3 months, the two groups will be~     re-evaluated in terms of postural alignment and balance.~   "
43273|NCT02490592|"~     Compare the remineralizing effect of acidulated fluoride gel Flugel (1.23% FFA, DFL) and~     acidulated Fluoride Foam Flúor Care (1.23% FFA, FGM) in maxillary anterior permanent teeth~     of 58 children aged 7 to 12 years of age.~      to verified the activity (visual scores) and the dimensional changes of whit spot lesions~     (with WHO probe and millimeter ruler), risk for caries (CAMBRA) and OHI-S (Simplified Oral~     Hygiene Index) of children.~   "
43274|NCT02490579|"~     The primary purpose of this study is to assess the responses of pregnant women and their~     social network to six videos about health in pregnancy. Our goal is to assess a)~     acceptability and b) understanding of core messages about healthy eating, exercise and~     weight gain during pregnancy. We will also assess c) non-clinical sources of health~     information during pregnancy.~   "
43275|NCT02490566|"~     Using technology alongside a pediatric chronic disease specialist and behavior specialist,~     the investigators are planning to help care for and coordinate the healthcare of children~     with chronic diseases, particularly childhood obesity, diabetes and asthma in Miami's most~     vulnerable communities. The University of (UM) Miller School of Medicine (MSOM) Pediatrics~     and TeleHealth departments propose to leverage information and communications technologies~     (ICT) in an innovative approach to improve the quality, access and efficiency of pediatric~     services for children and their families.~   "
43276|NCT02490553|"~     The ELISABET STUDY is across sectional Survey on a representative sample of two urban area~     conduct on a representative sample. The main objective of the project is to compare the~     prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk~     touched by the industrial pollution in relation to the one recovered in the Urban Community~     of Lille (CUDL) less industrialized.~   "
43277|NCT02490540|"~     There is accumulating evidence that inappropriate analgesia is asssociated with increasing~     risk of perioperative complications. The aim of the study is to compare intraoperative~     analgesia guided according to different methods of intraoperative analgesia monitoring, ANI~     and SPI respectively.~   "
43472|NCT02487979|"~     This phase II trial studies how well glembatumumab vedotin works in treating patients with~     osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).~     Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill~     them.~   "
43278|NCT02490527|"~     The purpose of this study is to gain insight into the side-effects of statin consumption,~     and assess the ability of epicatechin (a compound in dark chocolate) to counteract or~     reverse these changes. The investigators' prior research has shown that epicatechin can~     improve skeletal muscle structure and mitochondrial (which gives us energy) structure.~   "
43279|NCT02490514|"~     This open-label, non-randomized, retrospective-prospective, non-interventional study will~     evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney~     disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for~     12 months at a dose to be determined by the investigator.~   "
43280|NCT02490501|"~     This is an open, randomized, rehabilitation-controlled study in subjects with complete~     Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation~     of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).~   "
43281|NCT02490488|"~     The objective is to evaluate the efficacy and safety of masitinib in combination with~     gemcitabine in refractory ovarian cancer patients.~   "
43282|NCT02490475|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination~     of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors~     that have progressed during or after standard therapy, or for which no standard therapy is~     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs)~     in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).~   "
43283|NCT02490462|"~     The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to~     improving the neuromotor components at the level of structure and body function, must~     empower them to carry out their activities and daily tasks and enable their social~     participation. In this way, the goals of Physical Therapy are related to promote the~     independence and functionality of the individual in situations of daily life. The~     participation of caregivers in the rehabilitation process can contribute to potentiate the~     gains obtained by physical therapy as well as to which they are incorporated into the day to~     day management of children with cerebral palsy. Objective: To assess whether Physical~     Therapy associated with the education of caregivers is effective in improving the~     functioning and quality of life of children with cerebral palsy. Hypothesis: The combination~     of Physical therapy with the education of caregivers improves in 15% the parameters analyzed~     against only 10% in those who are only Physical Therapy. Methods: 60 children with cerebral~     palsy after acceptance and signature in the term of informed consent will be randomly~     divided into 2 groups (G1: Physiotherapy and education of caregivers and G2: only Physical~     Therapy) to do 3 sessions of Physical Therapy and 1 weekly session of group education with~     duration of 1 hours during 24 consecutive weeks. The evaluation will be carried out by means~     of the System of Classification of Motor Function Gross (GMFCS), the evaluation of Motor~     Function through the scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and~     Participation will be evaluated by the Inventory of Evaluation of Pediatric Disability~     (PEDI). The analysis of the results will be carried out using the Statistical Package for~     the Social Sciences (SPSS) using descriptive statistics for social and demographic~     characteristics and inferential for normality of data (test Kolmogorov-Smirnov ), mean~     comparison test to check for differences between the groups and measures of association~     through the coefficient of correlation. The level of significance of 5% will be established~   "
43284|NCT02490449|"~     This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after~     breakfast in patients with nonerosive reflux disease.~   "
43285|NCT02490436|"~     The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better~     than placebo for the treatment of neuropathic pain.~   "
43286|NCT02490423|"~     This study will determine whether a complex, data-driven protocol for assessing patient~     needs and providing nudges (reminders to be compliant with medication prescriptions)~     improves compliance with cardiovascular medications. This will be accomplished by performing~     a 12-month clinical trial of patients with an indication for statin therapy. Participants~     will be randomized to either an intervention or standard-of-care arm and will be followed~     via passive electronic means to determine if they are compliant with medication~     prescriptions.~   "
43287|NCT02490410|"~     The purpose of this study is to compare the effects of different dose of whey protein~     intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and~     muscular function state in the elderly with sacropenia.~   "
43288|NCT02490397|"~     The study tests if intense light could be a potential therapy in humans after myocardial~     infarction by inducing Per2.~   "
43289|NCT02490384|"~     This is a multicenter randomized study designed to determine if physical exam indicated~     cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women~     with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks~     of gestation.~   "
43290|NCT02490371|"~     Stroke is the leading cause of function disability or impairment. Non-promising functional~     return from upper limb rehabilitation has been reported. With the technology advances,~     transcranial magnetic stimulation (TMS), which is a form of non-invasive direct brain~     stimulation, may act as an attenuator in regulating or modulating the cortical excitability~     in order to facilitate cortical re-organization and enhance behavioral performance. Various~     therapeutic exercise protocols have been investigated regarding their efficacy in promoting~     motor recovery of the affected upper limb for patients after stroke and the preliminary~     results were supportive. However, limited numbers of randomized control clinical trials have~     been published in investigating the priming or additive value of low frequency~     repetitive TMS (rTMS) with combination of structural motor training programs.~      Thus the objective of this study is: to determine the effectiveness of the combination of~     low frequency rTMS on contra-lesional M1 and a structured upper limb motor training program~     on restoring upper limb function among patients with stroke in sub-acute stage. It is~     hypothesized that the rTMS, when combined with a structured motor training program, confers~     additional therapeutic effects on upper limb motor function in subacute stroke patients,~     when compared with the motor training program alone.~      The objectives of this study is to determine the effectiveness of the combination of low~     frequent rTMS on contra-lesional M1 and a structured upper limb motor training program in~     restoring upper limb function among patients with subacute stroke.~   "
43291|NCT02490358|"~     This study will collect sputum samples from healthy smokers, COPD smokers and COPD~     ex-smokers to analyse biomarkers of inflammation~   "
43292|NCT02490345|"~     The specific aims of this research study are to use 600 mg gabapentin as an adjunctive~     treatment for acute postoperative pain control in order to reduce postoperative opiate~     consumption and improve postoperative pain control.~   "
43338|NCT02489747|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on~     cognitive and memory function. The investigators measured changes in cognitive function~     parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF~   "
43293|NCT02490332|"~     The prevalence of otitis media among Greenlandic children is one of the highest in the world~     and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal~     speech. Yet, there are no national guidelines to ensure prevention and treatment of~     recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in~     Greenlandic children. International studies from the developed part of the world have shown~     that otitis prone children may benefit from tubulation of the tympanic membrane. However, it~     is unknown if these results can be applied to Greenlandic children.~      This PhD project will conduct a randomised controlled trial comparing tubulation of the~     tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis~     media and/or chronic otitis media with effusion, to conservative treatment. The children~     will be followed for two years. Outcome measures will include number of visits to health~     clinics, number of tympanic membrane perforations, number of episodes with acute otitis~     media according to medical records, Quality of life, measured by the validated~     questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or~     intravenous antibiotics have been administered according to medical records and serious~     adverse events~      The trial will be conducted in collaboration with the Greenlandic health authorities and~     Copenhagen Trial Unit.~      With this trial the investigators hope to decrease the number of episodes with acute otitis~     media, the number of Greenlandic children with chronic perforations of the tympanic membrane~     and hearing impairment and increase quality of life.~      The results will add important knowledge to the effect of ventilation tube treatment also in~     an international aspect. There are to date only less than a handful of high quality studies~     concerning this issue on an international basis. The study will be among the first~     addressing this problem among populations with high risk of otitis media and is also of~     interest to other indigenous populations and the developing part of the world.~   "
43294|NCT02490319|"~     Radiation pneumonitis is the most common complication and the major dose-limiting toxicity~     associated with radiotherapy, which can cause poor quality of life or life-threatening~     symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently,~     establishing reliable predictors for the occurrence of RP is of great significance such that~     the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim~     of this study is to figure out the biological prediction models of radiation pneumonitis.~   "
43295|NCT02490306|"~     This is a prospective, open, multicenter study that will enroll patients with clinical signs~     of stroke in the prehospital setting. A follow-up microwave measurement will be performed by~     the hospital investigator for the patients admitted to the Stroke Unit at Sahlgrenska~     University Hospital in conjunction with a CT scan, if this is performed as part of the~     standard of care within 48 hours of stroke onset. The study assesses the diagnostic~     capability, measurement performance, safety and usability of Strokefinder MD100 in a~     prehospital environment.~   "
43296|NCT02490293|"~     During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use~     the postoperative antibiotics after surgery. However, there is no consensus regarding the~     actual need of postoperative antibiotics in these cases and the use of postoperative~     antibiotics remains controversial.~      Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the~     patients who has no evidence of systemic infection, according to the usage of postoperative~     antibiotics or not. The investigators expect that the routine use of postoperative~     antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have~     no effects on the postoperative morbidity.~   "
43297|NCT02490280|"~     The purpose of this study is to investigate how healthy youth and adults' cortisol levels~     and other hormone levels relate to anxiety levels while they participate in a behavioral~     task called the Trier Social Stress Task.~      Data from these healthy participants will also be compared to those of anxious youth and~     adults collected as part of the in the Principal Investigator's ongoing study titled,~     Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687).~   "
43298|NCT02490267|"~     The management of childhood glaucoma (CG), childhood cataract (CC) and other birth defects~     affecting the eyes requires frequent hospital attendances and often multiple surgical and~     medical interventions, and are often associated with poor vision. Chronic medical conditions~     and vision impairment can affect quality of life (QoL). The QoL of children with the above~     conditions has not previously been evaluated.~   "
43299|NCT02490254|"~     The investigators wish to establish a robust estimate of the incidence of inflammation~     inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children~     present to, where they are referred to, which treatment they receive during the first year~     after diagnosis, and how well they can see at the end of the first year.~   "
43300|NCT02490241|"~     Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation~     to medication therapy for Major Depression, is commonly continued in pregnancy due to its~     therapeutic benefit and more recent data that suggests the teratogenic effects of lithium~     are less than historically believed. Due to the increased elimination of lithium during~     pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to~     BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the~     risk for postpartum exacerbation of BD and psychosis. Our study will investigate the~     pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum.~     Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium~     will be invited to participate in a study to measure repeated blood levels of lithium at six~     time points between preconception and 3 months postpartum. The data collected will inform~     the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer~     untoward effects for the mother and baby. Change in elimination clearance of lithium will be~     correlated with symptom worsening to develop a dosing algorithm that will help maintain~     wellness for pregnant women with mood disorders.~   "
43301|NCT02490228|"~     To explore the minimally invasive and exhaustive treatment of female urethral canruncle by~     using trans-artificial-urethral resection of the canruncle. The investigators plant to~     recruit patients using this surgical method and study the effectivity of this method.~   "
43302|NCT02490215|"~     The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients~     admitted to intensive care units(ICUs). It represents a significant public health issue. No~     large nationwide, multicenters study of ARDS has been conducted in China. The purposes of~     this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors~     associated the mortality ; and 3) risk factors for development of ARDS .~   "
43303|NCT02490202|"~     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in~     patients who will be recipients of a donation after brain death (DBD) donor kidney.~   "
43304|NCT02490189|"~     To conduct a prospective, randomized trial to compare the efficacy of a group~     mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus~     cognitive behavior group therapy (CBGT).~   "
43339|NCT02489734|"~     The purpose of this study is to determine whether the incidence of emergence delirium will~     be reduced when end-tidal concentration of sevoflurane decreases.~   "
43306|NCT02490163|"~     In a study performed in 2012, the investigators demonstrated that in ECP setting , the new~     automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on~     intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More~     recently (in 2013), Terumo BCT released another automated system that allows to collect stem~     cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over~     study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and~     contamination) of MNCs collected from patients undergoing ECP with two different automated~     systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection~     procedure.~   "
43307|NCT02490150|"~     To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after~     pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant~     follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.~   "
43308|NCT02490137|"~     The purpose is to use MRI to investigate brain changes associated with playing a race car~     video game for 90 minutes in aging adults both with and without early signs of dementia.~   "
43309|NCT02490124|"~     Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic~     patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia,~     conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin~     Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with~     DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which~     is characterized by impaired vasodilatory action of insulin on resistance or microvascular~     vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young~     adults DM1 impairs both baseline and insulin-responsive vascular function throughout the~     arterial vasculature.~   "
43310|NCT02490111|"~     This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone~     formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants~     will receive DWJ1319, while the other will receive a placebo.~   "
43311|NCT02490098|"~     Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the~     carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the~     main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting~     is a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in~     order to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia,~     respectively. Precision of carbohydrate counting is associated with better glycemic control.~     However, accurate carbohydrate counting is a challenging task for many patients with type 1~     diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have~     motivated the research toward closed-loop'' strategies to regulate glucose levels in~     patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is~     altered based on a computer generated recommendation that rely on continuous glucose sensor~     readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate~     glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by~     subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy~     still needs some improvements. The objective of this study is to test in outpatient~     unrestricted settings whether, in the context of closed-loop strategy, conventional meal~     carbohydrate counting could be reduced to a simplified qualitative meal size estimation~     without a significant degradation in overall glycemic control in children and adult patients~     with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop~     strategy with qualitative meal size estimation is equivalent to dual-hormone closed-loop~     strategy with CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy~     with qualitative meal size estimation is equivalent to single-hormone closed-loop strategy~     with CHO counting in terms of mean glucose;~   "
43312|NCT02490085|"~     The introduction of insulin pump therapy in patients with type 2 diabetes using multiple~     daily injections and poorly controlled can be considered in order to improve glycemic~     control. Recent developments of continuous glucose sensors and insulin infusion pumps have~     motivated the research toward closed-loop'' strategies to regulate glucose levels for~     patients with diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered~     based on a computer generated recommendation that rely on continuous glucose sensor~     readings. This study confirmed the feasibility and potential of the closed-loop strategy to~     improve glycemic control while reducing the risk of hypoglycemia in patients with type 2~     diabetes but did not target the population most likely to benefit from this strategy.The~     objective ot this study is to compare the efficacy of closed-loop strategy to multiple daily~     injections in regulating glucose levels for 24 hours in elderly adults with type 2 diabetes~     under intensive insulin therapy. The investigators hypothesize that closed-loop strategy~     will increase the time spent in the target range in adults with type 2 diabetes compared to~     multiple daily injections.~   "
43313|NCT02490072|"~     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary~     anesthetic, an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its~     cardiovascular effect through activation of receptors in central and peripheral nervous~     system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial~     shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There~     were several reports about these hemodynamic changs of dexmedetomidine, but not the~     evaluation of direct cardiac function of patients who was preexisted diastolic dysfunction.~     The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic~     adjuvant in diastolic dysfunction by using the echocardiography.~   "
43314|NCT02490059|"~     The evaluation of solitary pulmonary nodules (SPN) requires a balance between~     procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis~     is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this~     prospective randomised trial we compared diagnostic yield and adverse events of UB with~     standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible~     range of SB.~   "
43315|NCT02490046|"~     This is a study to explore the feasibility of using D-mannose, a commonly used food~     supplement, in persons with multiple sclerosis reporting recurrent urinary tract infections.~     Twenty persons with multiple sclerosis (10 patients using catheters and 10 not using~     catheters) reporting recurrent urinary tract infections will receive D-mannose 1.5 grams~     twice daily for 16 weeks duration.~      This will be explored through:~        1. Assessing compliance to a 16-week course of D-mannose~        2. Quantifying the number of prescriptions for antibiotics during the 16 weeks course of~          D-mannose~   "
43316|NCT02490033|"~     Catheter ablation is now routinely used in the management of heart rhythm disorders. One of~     the problems with the approach is that it has not been possible to determine whether the~     ablation catheter is in direct contact with the heart tissue or not. This is important~     because too much contact has safety implications and too little means that the therapy will~     be ineffective. Recently two different technologies have been developed to determine~     contact. Currently it is not know if one is superior to the other, and the objective of this~     trial is to determine whether there is a difference when treating a rhythm called atrial~     flutter.~   "
43317|NCT02490020|"~     Although donation after cardiac death(DCD) is the major source of renal transplantation in~     China, high incidence rate of rejection and delayed graft function(DGF) is existing due to~     the prolonged ischemia time. According to the previous single center study, mesenchymal stem~     cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there~     was no perspective multicenter controlled study to confirm it. This perspective multicenter~     controlled study will focus on clarifying the key role of MSC applied via renal arterial or~     peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The~     investigators have established GMP workshop and solid research foundation of transplant~     rejection. This study will provide a new reasonable way for immune induction of renal~     transplantation by DCD.~   "
43318|NCT02490007|"~     Aim To assess the possible food allergy-preventive benefit of using whole cell pertussis(wP)~     vaccination compared with acelluar pertussis vaccine(aP) for whooping cough vaccination in~     childhood.~      Background Whooping cough, caused by the bacteria, Bordetella pertussis, represents a~     significant public health burden in Australia and around the world. Acellular pertussis~     vaccination (aP) replaced whole cell vaccination against pertussis (wP) in the late 1990s.~     This replacement coincides temporally in an observed rapid rise in the occurrence of severe~     food allergy responses. Previous research has suggested that acellular pertussis vaccination~     results in the development of immunity that may predispose children to allergic responses. A~     retrospective case-controlled trial design, targeting cases of previously diagnosed allergy,~     and comparing case vaccination history to that of the whole population, is a powerful means~     of assessing the association between immunisation and allergy.~      Participant Groups 1000 allergy cases, 10,000 controls~      Project Design This is a retrospective individually-matched case-control study of Australian~     children born during the period of transition from use of wP vaccines to aP vaccines (year~     of birth 1997-1999 inclusive) and who are registered on the Australian Children Immunisation~     Register. Cases will be drawn from allergy clinics associated with tertiary teaching~     hospitals around Australia.~      Methods Cases: will be retrospectively identified from patient lists from allergy clinics~     around Australia, born during the period of pertussis vaccine changeover, and be confirmed~     to have IgE-mediated food allergy on the basis of 1) a documented history of consistent~     clinical symptoms following ingestion of an implicated food, and 2) evidence of~     sensitisation to that food via laboratory testing.~      Controls: Controls will be sampled from a de-identified database of children born during the~     transition from wP to aP vaccination appearing on the ACIR. Cases and controls will be~     matched by date of birth (+/-7 days), jurisdiction and socioeconomic decile.~      Expected outcomes: Following the study, investigators will be able determine if there is an~     association between the type of vaccination received and development of IgE mediated food~     allergy. If whole cell vaccination is found to have a protective association against the~     development of allergy, this will have profound impact on health policy in Australia and~     around the world.~   "
43319|NCT02489994|"~     Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of~     Cellulite.~   "
43320|NCT02489981|"~     The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva®~     Respimat®) in patients with severe persistent asthma under the real-world use was not~     confirmed in clinical trials.~   "
43321|NCT02489968|"~     Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will~     evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg +~     linagliptin. All analyses will be carried out separately for these study parts. The~     objective of Part A is to investigate the efficacy, safety and tolerability of the fixed~     dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin~     10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese~     patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with~     empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC~     of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo~     after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety~     and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with~     empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in~     Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of~     treatment with empagliflozin 25 mg alone once daily. The study is designed to show~     superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg~     plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be~     followed by a 28 week extension treatment period to evaluate further efficacy and safety up~     to 52 weeks.~   "
43322|NCT02489955|"~     Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce~     the long term damage to their lungs from infection. This would typically be with a two week~     course of intravenous antibiotics each time they have a chest infection (typically three to~     four times a year).~      The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot~     be used because of previous side effects, allergy or a resistant infection then colomycin or~     amikacin are usually used. Each of these antibiotics are known to be toxic to both the~     kidneys and ear. As patients are living longer (into their forties), the total amount of~     these antibiotics they are receiving over their lifetime is increasing. This is now leading~     to increased complications such as kidney damage and hearing loss. Because of this, the~     investigators need to look at methods to accurately quantify damage and reduce potential~     kidney and hearing damage.~      The investigators intend to quantify kidney damage by measuring new protein markers within~     the urine and blood that signify kidney damage before more conventional and currently~     available methods are able to.In those patients treated with intravenous tobramycin the~     investigators will also look at an alternative method used to calculate the most appropriate~     dose of antibiotic for each participant. This dosing method is called 'area under the curve~     or AUC' dose monitoring. This method currently in clinical use in other countries is thought~     to more accurately reflect the most appropriate dose for each participant and thus reduce~     the chance of kidney and hearing problems. This 'AUC' method requires two rather than one~     dose level to be checked each time a dose calculation is made. Participants receiving~     tobramycin will be randomised to receive dosing by this method or the investigators'~     currently used method of 'trough' monitoring.~   "
43323|NCT02489942|"~     Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in~     Japanese patients with type 2 diabetes mellitus~   "
43324|NCT02489929|"~     Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive~     bone marrow failure that result in ineffective production of blood cells. Depending on the~     severity, MDS reduces the quality of life to the point of being life-threatening. There is a~     probability of death at all stages of the disease, due to complications and co-morbidities,~     with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a~     nucleosidic analog with original epigenetic mechanism of action that is widely used for~     treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe~     and sometimes life-threatening toxicities were unexpectedly observed in some patients.~     Genetic polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for~     azacytidine detoxification step, could be responsible for poor clinical outcome due to on~     the one hand to severe toxicities in deficient patients, and on the other hand on treatment~     failure in ultrametabolizer patients.This clinical study aims at correlating the values in~     CDA levels with the risk of drug-related toxicities and to the clinical response to~     azacytidine treatment.~   "
43325|NCT02489916|"~     The investigators do the clinical trial (patients with metastatic colorectal cancer treated~     with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib~     in patients with metastatic colorectal cancer, progressing after all approved standard~     therapies.~   "
43327|NCT02489890|"~     Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse~     remains the major cause of treatment failure.Biological therapies such as CIK stimulate the~     immune system and stop tumor cells from growing. A series of studies reported that~     cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators~     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy~     may kill more tumor cells. In this study, the patients will be treated with CIK cells after~     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder~     Cancer.~   "
43328|NCT02489877|"~     Multiple sclerosis is the most common autoimmune inflammatory disease of the central nervous~     system. It is known that your etiology has genetic and environmental causes. Several viruses~     have been implicated as triggers as well as perpetrators of this disease. Several studies~     make the correlation between Endogenous Retrovirus Type W (HERV-W) and the family~     Herpesviridae and activity in the pathogenesis of multiple sclerosis. The most important~     characteristics of the virus implicated in the pathogenesis of the disease is the fact that~     they have latency periods of exacerbation and they have, as their main biological~     environment, the central nervous system. The HERV-W, Epstein-Barr virus (EBV),~     cytomegalovirus, herpes virus type 6 and type 7 herpesvirus members are the most studied as~     causes of multiple sclerosis. It was found that these viruses are closely involved in the~     pathogenesis of MS, but it is believed that aren't the only responsible for its beginning.~     It is likely that this disease presents numerous triggers and more studies are needed to~     determine these interactions. In addition, a study comparing the activity of multiple~     sclerosis with the presence of these viruses was never realized.~   "
43329|NCT02489864|"~     Appreciation of the central role for arterial vasodilatation in the pathogenesis of~     hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with~     albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal~     approach for such therapies has not yet been established. As compared with albumin,~     treatment with terlipressin and albumin is effective in improving renal function in patients~     with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial~     pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with~     ascites. The purpose of this study was to examine the role of targeting an early and~     substantial increase in mean arterial pressure in the prevention of type 2 HRS.~   "
43330|NCT02489851|"~     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage~     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local~     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread~     of the local anesthetic agents may produce extensive analgesia and prolonged action of the~     injected local anesthetic solution.~      Previous studies showed that both TAP block and QLB may reduce morphine requirements in the~     postoperative period in patients who had cesarean section under spinal anaesthesia. However~     there are no published reports comparing the 2 techniques.~      The aim of this randomised controlled, double blinded study is to compare the analgesic~     efficacy of QLB compared to TAP block in patients who had cesarean section under spinal~     anesthesia.~   "
43331|NCT02489838|"~     To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for~     Liver Cancer.~   "
43332|NCT02489825|"~     Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized~     controlled trials (RCTs) with substantial methodological problems have led to an intense~     discussion another RCT with larger case numbers, more representative inclusion criteria and~     a more consistent and sound methodology has revealed results that mirror the investigators'~     own clinical experience. In their daily practice, the investigators have further advanced~     their treatment concept and routinely apply prophylactic augmentations with VP using an~     algorithm. Biomechanical studies support their approach, but clinical studies are rare so~     far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in~     a small pilot study. Given the above mentioned methodological and clinical disputes and the~     call for high-evidence studies about VP, the investigators aim at generating a reliable~     sample size calculation and preliminary results for a future multicenter RCT about~     prophylactic adjacent level augmentation with VP in single level osteoporotic compression~     fractures.~   "
43333|NCT02489812|"~     Music plays an important role reassuring helping reduce anxiety. Anxiety can be an~     interference factor in promoting oral health for children with high levels of anxiety tend~     to have negative behavior at the dentist. High oxygen levels and heart and respiratory~     frequencies are associated with high levels of anxiety. The objective of this study was to~     test the use of music in decreased cardiac and respiratory frequency of treated patients~     listening to music and being treated without hearing music.~   "
43334|NCT02489799|"~     Through close engagement with our patient and family member co-investigators, the~     investigators have developed a video-based advance care planning aid for cancer patients and~     their family members who are preparing for major surgery. In this study, patients are~     randomized to see either the intervention video (involving advance care planning-related~     content) or a control video (no advance care planning-related content) prior to surgery. The~     investigators hypothesize that the video will lead to more and better preoperative~     discussions between the patient and surgeon that are related to advance care planning. The~     investigators also hypothesize that seeing the advance care planning-related video will~     decrease perioperative anxiety and depression scores.~   "
43335|NCT02489786|"~     Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic~     index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt,~     most cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it~     is not clear if the interrupted digoxin regimens are effective since serum digoxin~     concentrations might fall below the therapeutic range.~      Objective: To evaluate and compare the digoxin serum concentration and patient's quality of~     life in the continuous versus interrupted digoxin dosing regimens.~   "
43336|NCT02489773|"~     To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding~     2-3 weeks) monitoring of glycemic control in patients with diabetes.~   "
43337|NCT02489760|"~     To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated~     AS patients.~   "
43354|NCT02489526|"~     The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic~     drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind,~     parallel, placebo-controlled study.~   "
43340|NCT02489721|"~     Most important peripherally inserted central catheter (PICC) and Midline complications are~     thrombosis and catheter related blood stream infections. No large prospective observational~     study are present in literature about these topics. The aim of this multicenter prospective~     observational study is to analyze all the complications due to PICC and Midline insertion.~   "
43341|NCT02489708|"~     This two phase study will develop and evaluate a Pediatric Emergency Department (PED)~     Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the~     identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure~     intervention to caregivers who bring their child to the PED.~   "
43342|NCT02489695|"~     Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients~     with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line~     treatment.~   "
43343|NCT02489682|"~     This study evaluates the effectiveness of a patient-centered short written informed consent~     form and a patient-centered short video informed consent in a randomized controlled trial~     (control = traditional informed consent ). Primary outcome measures include critical~     knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical~     clinical trial. The investigators hypothesized that the patient-centered patient-designed~     consent forms (video and written format) would do as well as or outperform the traditional~     consent form on the primary outcomes.~   "
43344|NCT02489669|"~     The urine flow rate (UFR)-guided and the left-ventricular end-diastolic pressure~     (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute~     kidney injury (CI-AKI). The REnal Insufficiency Following Contrast MEDIA Administration~     TriaL III (REMEDIAL III) trial is a randomized, multicenter, investigator-sponsored trial~     aiming to compare these 2 hydration strategies in high risk patients.~      Patients with estimated glomerular filtration rate <45 ml/min/1.73 m2 and/or a high risk for~     CI-AKI (as defined according to both Mehran's score ≥11 and/or Gurm's score >7) will be~     enrolled. Patients will be divided in high (>12 mm Hg) and normal LVEDP, non-invasively~     estimated by transmitral flow velocity to annular velocity ratio (E/E' index). Patients in~     each group will be randomly assigned to 1) LVEDP-guided hydration with normal saline~     (LVEDP-guided group). The fluid infusion rate will be adjusted according to the LVEDP as~     follows: 5 mL/kg/hr for LVEDP <12 mmHg; 3 mL/kg/hr for 13-18 mmHg; and 1.5 mL/kg/hr for >18~     mmHg. 2) UFR-rate guided hydration (RenalGuard group). In this group, hydration with normal~     saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach~     and maintain a high (>300 mL/h) UFR. In all cases iobitridol (an low-osmolar, non ionic~     contrast agent) will be administered. The primary endpoint is the composite of CI-AKI (i.e.,~     serum creatinine increase ≥ 25% and ≥ 0.5 mg/dl from the baseline value at 48 hours after~     contrast media exposure) and/or acute pulmonary edema.~   "
43345|NCT02489656|"~     This study is a prospective, randomized multicenter study conducted in Europe. It is~     designed to compare two double loop ureteral stents in terms of the quality of life in~     patients operated on a kidney stone and requiring the placement of a double loop ureteral~     stent at the end of the operation.~   "
43346|NCT02489643|"~     The aim of the study will be to evaluate the impact of this individualized practical~     training on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface~     Area (BSA) score performed by a physician blinded to the study groups) and adherence~     (calculated as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4~     week long treatment with dovobet gel. On the other hand, the investigators will evaluate in~     both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact~     of quality of life,..) characteristics influence the adherence to the treatment.~   "
43347|NCT02489630|"~     This study investigates the use of low doses of ketamine, along with opiate pain medication,~     is more effective at controlling the acute pain of patients in the emergency department than~     opiate pain medication alone. In addition, this study examines whether patients treated with~     low doses of ketamine, along with opiate pain medication, will require less opiate pain~     medication to control their pain, and whether these patients are equally happy with their~     pain control as patients who receive only opiate pain medication.~   "
43348|NCT02489617|"~     This research study is studying a surgical intervention to rule out the presence of cancer~     in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal~     papilloma without atypia (IPWA) by core needle biopsy.~   "
43349|NCT02489604|"~     This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic~     Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG~     negative will be enrolled in the study and will be randomly assigned to 2 different dosages~     (total activity of 25.9 GBq and total activity of 18.5 GBq).~   "
43350|NCT02489591|"~     Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal~     structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific~     therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral~     appliance (OA) therapy is increasingly being indicated for OSA treatment, although a~     complete response occurs in approximately 50% of patients. In general, OA devices are~     designed to maintain the mandible and/or tongue in a protruded posture during sleep,~     preventing upper airway obstruction. Limited studies in awake or sedated patients have~     demonstrated the effects of mandibular advancement on aspects of pharyngeal structure and~     function. The objective of the proposed research is to fully characterize upper airway~     collapse in OSA patients during natural sleep and use this information to understand why~     some patients appear to exhibit a large improvement in pharyngeal collapsibility whereas~     others do not.~   "
43351|NCT02489578|"~     The purpose of this study is to evaluate the disease burden of hospitalized patients with~     CAP and healthcare-associated pneumonia (HCAP) in real life of China .~   "
43352|NCT02489565|"~     The purpose of this study is to determine whether the telemedicine use in primary health~     care is effective in the accompaniment of stable coronary artery disease patients who were~     discharged from the tertiary health care clinics.~   "
43353|NCT02489539|"~     The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER®~     Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal~     aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by~     separate performance goals.~   "
43356|NCT02489500|"~     Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant.~      This study will compare the safety and effectiveness of standard treatment with high-dose~     melphalan and stem cell transplant, compared with investigational bortezomib when used in~     combination with standard treatment with high-dose melphalan and stem cell transplant for AL~     amyloidosis.~   "
43357|NCT02489487|"~     A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500~     given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The~     parallel design is used due to the long half life for VM-1500.~   "
43358|NCT02489474|"~     Some of the liver transplantation recipients experience postoperative acute kidney injury~     due to various causes including genetic factors. Prevention of postoperative acute kidney~     injury is essential for postoperative care in liver transplantation recipients. The aim of~     this study is to investigate the relationship between gene polymorphisms which have been~     known to be associated with postoperative acute kidney injury, and the occurrence of acute~     kidney injury after liver transplantation.~   "
43359|NCT02489461|"~     To evaluate the following safety and efficacy parameters for VM-1500:~        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 12 (Stage I)~        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 24 (Stage II)~        -  Decrease in viral load during 48 weeks of treatment~        -  Percentage of subjects with at least 10-fold (1 log10) decrease in viral load at Week 4~        -  Percentage of subjects with decrease in viral load to <400 copies/ml at Week 12~        -  Percentage of subjects who continued to receive the investigational treatment up to~          Week 48~        -  СD4+ and СD8+ cell count change during 48 weeks of the study~        -  Percentage of subject who developed HIV-1 resistance to the investigational treatment~          by week 48~        -  Frequency of adverse events (AE) of different severity according to subjective~          complaints, physical assessment, vital signs, laboratory tests, ECG~        -  Frequency of adverse events of special interest, including of central nervous system~          (CNS) effects~        -  VM-1500 pharmacokinetic profile in selected subjects~   "
43360|NCT02489448|"~     The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with~     MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736~     concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete~     response (pCR) rate (>55%) in triple negative breast cancer than historical pCR rates~     (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at~     full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2~     respectively).~   "
43361|NCT02489435|"~     The purpose of the study to assess safety and tolerability of VM-1500 and to determine main~     pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy~     subjects.~   "
43362|NCT02489422|"~     This randomized pilot trial studies how well two supportive programs work for improving~     fatigue and depressive symptoms in patients with stage II-IV colorectal cancer undergoing~     chemotherapy. Possible mediators such as psychological stress, circadian disruption, and~     inflammation, will also be explored.~   "
43363|NCT02489409|"~     Endostatin has been widely applied for the clinical treatment of partial primary and~     metastatic solid tumors. Endostatin combined with chemotherapy has achieved favorable~     progression in the treatment of non-small cell lung cancer (NSCLC). However, the research~     about the efficacy of Endostatin on breast cancer has just started. Breast cancer is a~     highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin~     therapy. Additionally, after chemo- and radiotherapy, the primary nidi of patients with~     advanced breast cancer may also lead to rapid development of tumors in other locations. So~     Endostatin combined with chemotherapy can also improve the prognosis of patients with~     recurrent metastatic breast cancer, but there is rare any report at home and abroad. To~     further explore the above research, this study designed a randomized, opened and controlled~     clinical study to observe the clinical efficacy of EndostarTM Injection combined with~     GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.~   "
43364|NCT02489396|"~     Rationale: Online-grocery shopping is predicted to be one of the hottest food trends of~     2014, as national retailers such as Amazon, as well as start-up companies, venture into the~     e- commerce grocery sector. Importantly, the online-grocery environment could be uniquely~     manipulated to promote healthier food purchasing and help with weight control. Since~     consumers tend to choose items listed first on menus and buffet lines, the order of food~     products displayed on the grocer's website may impact purchasing. Furthermore, it's possible~     that in an online-grocery environment, nutrition information could be made more salient to~     consumers. For example, previous research has demonstrated that label color influences~     perceptions of the healthfulness of foods. The FDA also recently proposed a redesign of~     foods' nutrition facts panels, which would highlight calorie content in a larger font.~     Although implementing this label change on all food labels could take years, e-commerce~     sites could change the format of the nutritional information they display much more quickly.~      Objectives: The proposed study intends to nudge consumers to make healthier grocery~     purchases through three distinct interventions: 1.) Manipulating the order of food items~     within grocery categories; 2.) Displaying product nutrition information in red or green; and~     3.) Presenting calorie information in a larger font size. We propose to examine these~     concepts in adult consumers using a grocery e-commerce platform servicing socioeconomically~     and racially diverse communities in the northeastern U.S.~   "
43365|NCT02489383|"~     The treatment of asthma is based in clinical control. However, previous studies have been~     shown that patients that participate of the programs of regular or aerobic continuous~     exercise training (CT) presented improvements in the physical conditioning, and quality~     life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric~     exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness.~     The regular exercise also is important part in the rehabilitation of other lung disease as~     well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been~     shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation~     of COPD patients, that after performed IT presented reduction of dyspnea, and increase the~     physical capacity. In this sense, the impact of IT in the asthmatic patients at the present~     moment is poorly studied, and necessity of the more investigation to prove the efficiency of~     this training model for asthma patients.~   "
43366|NCT02489370|"~     Providing patients with chronic heart failure (CHF) access to remote monitoring, for example~     by telephone or telemonitoring using wireless technology, reduces deaths and~     hospitalisations and may provide benefits on health care costs and quality of life. Remote~     monitoring of patients with chronic heart failure can reduce pressure on resources,~     particularly for conditions like chronic heart failure, which exert a large burden on health~     services. These are conclusions of the Cochrane Systematic Review from 2010.~      In Norway the costs for treatment of chronic heart failure are vast, both concerning~     hospital treatment, daily use of medication over years, and loss of quality of life for~     patients and their family caregivers. Generally there is little knowledge about what is~     gained for the billions used. In Norway no telemonitoring services are established and hence~     no investigations have yet been published. Thus it seems that current evidence of~     effectiveness and quality is insufficient to recommend usage. The structure and funding~     streams in Norwegian health services are different from other countries and the conventional~     services that the intervention has been compared to in previous studies, are most likely~     heterogeneous. It is thus important to investigate Norwegian conditions.~      Advanced telemonitoring technology with electronic transfer of physiological data such as~     blood pressure and weight is currently being used in research and established routine~     services in several countries in Europe, amongst them the Netherlands, Germany and the~     United Kingdom.~      The proposed project intends to introduce such a strategy as an avenue for exploring~     promising new services that would not otherwise be available in Norway. The service consists~     of daily monitoring the patients' weight and blood pressure directly from their home;~     automatically and securely transmit the values to a server at the University Hospital of~     North Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.~      The primary objective of this study is thus to explore whether, as compared to current care~     from the Heart Polyclinic, the introduction of home telemonitoring will reduce hospital~     readmissions and will, in addition, be cost-effective. This is in line with current~     directions of European telemonitoring programmes for patients with chronic heart failure.~     This result may define if the telemonitoring of heart failure patients is feasible for~     Norway or not at all.~   "
43367|NCT02489357|"~     This pilot phase II trial studies the side effects and how well pembrolizumab and~     cryosurgery work with short term androgen ablation to treat patients with prostate cancer~     that has traveled from the original tumor, through the body, and formed a small number of~     new tumors in other parts of the body (oligo-metastatic). Cryosurgery, also known as~     cryoablation or cryotherapy, kills tumor cells by freezing them. The process also incites an~     immune response within the ablated tumor. Giving monoclonal antibodies such as pembrolizumab~     which enhance a systemic anti-cancer immune response, may augment the effects of cryosurgery~     and increase tumor killing at distant (metastatic) sites.~   "
43368|NCT02489344|"~     Primary Objective:~      To assess the long-term safety of GZ/SAR402671 in adult male patients with Fabry disease who~     previously completed study ACT13739.~      Secondary Objective:~      To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy~     endpoints in adult male patients with Fabry disease who previously completed study ACT13739.~   "
43369|NCT02489331|"~     Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the~     New Drug Re-examination~   "
43370|NCT02489318|"~     The purpose of this study is to determine if the addition of apalutamide to ADT provides~     superior efficacy in improving radiographic progression-free survival (rPFS) or overall~     survival (OS) for participants with mHSPC.~   "
43371|NCT02489305|"~     The purpose of this study is to identify if there are self-reported or objective measures~     related to mood parameters that can predict near-term relapse (within 1 month or at another~     identified time point before meeting the criteria for relapse) or early symptomatic changes~     indicative of relapse prodrome in major depressive disorder (MDD).~   "
43372|NCT02489292|"~     The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients~     suffering from urea cycle disorders.~   "
43373|NCT02489279|"~     The purpose of this study is to evaluate the effects of different types of cognitive~     training on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using~     mobile software on personal mobile devices.~   "
43374|NCT02489266|"~     Background:~      - One cancer therapy involves taking white blood cells from a person, changing them in a~     lab, and then giving the cells back to the person. These cells are called tumor infiltrating~     lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see~     if they live longer than those grown without it.~      Objectives:~      - To see if TIL cells grown with Akti live longer than those grown without it.~      Eligibility:~      - Adults 18 70 with metastatic melanoma~      Design:~        -  Participants will:~        -  Be screened with tests including scans, x-rays, heart and lung tests, blood and urine~          tests, and a <TAB>possible colonoscopy.~        -  Have tumor surgery or biopsy.~        -  Have a large catheter inserted into a vein in the upper chest.~        -  Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White~          blood cells <TAB>are removed. The rest of the blood is returned by needle in the other~          arm.~        -  The cells will be changed in a laboratory.~        -  Participants will check into the hospital and:~        -  For 5 days, get 1 2 chemotherapy drugs by catheter.~        -  For 1 3 days, get the changed cells by catheter.~        -  For several days, get 2 drugs to stimulate cells, one by injection, the other by~          catheter.~        -  For 7 12 days, recover in the hospital.~        -  After treatment, participants will:~        -  Take an antibiotic and antiviral for at least 6 months.~        -  Return to NIH for several 2-day visits for a few years. At each visit, participants~          will have lab tests, imaging studies, and a physical exam. At some visits, they may~          have leukapheresis or blood tests.~   "
43375|NCT02489253|"~     Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in~     500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in~     monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a~     coronary CT angiogram and biochemical biomarkers.~   "
43376|NCT02489240|"~     The investigators planned to research the effect of vitamin D supplementation on the~     incidence of contrast-induced nephropathy in patients undergoing coronary angiography.~   "
43377|NCT02489227|"~     This is a 3-part study comparing CHS-1420 to Humira in patients with chronic plaque~     psoriasis.~   "
43378|NCT02489214|"~     This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib~     in advanced gastric cancer.~   "
43379|NCT02489201|"~     This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine~     kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced,~     inoperable oesophageal cancer progressing after chemotherapy .~      The primary endpoint is the safety.The secondary endpoints are tumor response and~     progression-free survival.~   "
43473|NCT02487966|"~     This study explores the effects of mirror therapy and transcranial Direct Current~     Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients~     will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT;~     active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both~     sham tDCS and sham MT (covered mirror).~   "
43380|NCT02489188|"~     To date, detailed analysis of movement patterns in orthopaedic conditions are mainly~     performed in research projects. Because these tests are time consuming, they are not~     feasible in clinical routine or in standard examinations. Novel technologies allow capturing~     detailed movement patters within a few minutes. The aim of this regional study is to compare~     aspects of movement tasks measured using a mobile gait analysis system to those measured~     using laboratory based systems and to determine aspects of gait patterns relevant for~     different orthopaedic conditions. Moreover, the researchers will investigate if these~     relevant aspects can be altered using surgical treatment or manual therapy.~   "
43381|NCT02489175|"~     Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact~     on patients' quality of life. Half of the stomas created each year are permanent and up to~     50% of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or~     colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain,~     poor fitting appliance with leakage and therefore, skin irritation, and can also be~     complicated by strangulation or occlusion. The literature reports that 30% of patients with~     a PSH will require surgery. There are many different surgical procedures to repair PSH:~     primary fascia repair, relocation of the stoma or repair with various type of mesh. Despite~     the efforts done to improve the techniques, the incidence of recurrent PSH is up to 70%~     dependent of the used technique. Therefore, the idea of implanting a mesh at the time of~     initial stoma formation has lately been advocated. A new device, the KoringKM, which is a~     stomaplasty ring made of propylene, flexible and non-absorbable, was created. This study~     will try to prove that incorporation of the new stomaplasty ring at the time of stoma~     creation will diminish long-term PSH rate. This hypothesis will improve patient's quality of~     life and reduce costs associated with PSH.~      All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease~     and fulfilling the inclusion criteria are eligible to participate in the trial. The patients~     will be randomized 24 to 48 hours prior to surgery after given written informed consent. The~     implantation of the Koring will be perfomed by experienced surgeons (expertise based, best~     team approach) who have already implanted the Koring (e.g. participated in the observational~     study) and/or have reviewed the video documentation. The surgeon will fill out the first~     form with the data of the patient and of the surgical procedure. The surgical wound will be~     daily examined. A second form will be fill out during the 30 post-operative days visit. The~     patients will be asked to inform the surgeon and/or investigator if any side event or~     suspicion of infection occurs after hospital discharge. The next follow-up visits will be at~     one and two years including a clinical examination and an abdominal CT. At this moment, the~     3rd and 4th forms will be documented. All data will be anonymised and included in an Excel~     database.~   "
43382|NCT02489162|"~     The objective of the research is to determine whether the MyotonPRO has a valid and reliable~     application in facial, head and neck surgery. In addition, the study aims to compare this~     new technology with current electromyography.~   "
43383|NCT02489149|"~     To optimize the food security in quilombolas communities with high prevalence of food~     insecurity and obesity, the present study proposes to test a multi-sector intervention~     including agriculture sectors, health professionals and family members of communities, based~     on promotion of traditional food practices, health eating and enforceability of human right~     to adequate food.~   "
43384|NCT02489136|"~     Stress is a multiple variable and an inevitable aspect of life. Any change that affects the~     life of a person is a stressful agent, being possible to widely vary its nature and may be~     formed by several components, since psychosocial and behavioral factors, such as~     frustration, anxiety and overload. The goal is to assess the effects of laying on of hands~     on newborns and patients without direct physical contact. Newborns are allocated in two~     three groups: G1 - group submitted to imposition of hands by workers, for a period of 10~     minutes; G2 group submitted to laying on of hands for 10 minutes; and adults are allocated~     three groups: G1 - group submitted to imposition of hands by workers, for a period of 10~     minutes; G2 group submitted to laying on of hands for 10 minutes; in G3: group without~     intervention, for a period of 10 minutes.~   "
43385|NCT02489123|"~     This pilot clinical trial studies enzalutamide in treating patients with mantle cell~     lymphoma that has returned after a period of improvement (relapsed) or has not responded to~     previous treatment (refractory). Androgens can cause the growth of cancer cells. Antihormone~     therapy, such as enzalutamide, may lessen the amount of androgen made by the body.~   "
43386|NCT02489110|"~     Photozig and Stanford University are creating a new program for Hispanic dementia caregivers~     to help cope with caregiving, alleviate related stress, and enhance quality of life for~     caregivers, with funding from the National Institute on Aging. The program includes a new~     education online telenovela (Webnovela), online resources, handouts and a DVD (for users~     without Internet) on how to deal with caregiving stress and handle difficult situations.~   "
43387|NCT02489097|"~     The study is a substudy of the Enigma2 trial which aims at investigating the effectiveness~     and safety of nitrous oxide (N2O) in anaesthesia.The substudy focus is on postoperative~     cognitive disorders.~      Substudy Hypothesis: In patients undergoing anaesthesia for major surgery, administration of~     N2O will reduce postoperative cognitive disorders when compared with otherwise identically~     managed surgical patients not receiving N2O as a component of their anaesthesia.~   "
43388|NCT02489084|"~     Background of the study:~      Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced~     side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients~     and have a major impact on the general dimensions of quality of life (QoL). In~     radiation0oncology, normal tissue complication probability (NTCP) models based on~     dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models~     containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms~     (SNPs), may improve model performance and thus enable more individualized radiotherapy.~     Information of the predictive value of SNPs or SNP signatures among patients with HNC is~     currently not available.~      Objective of the study:~      The main objective of this project will be to test the hypothesis that SNP profiles can~     improve the performance of predictive models for the most frequently reported late RISE,~     i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be~     improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute~     mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late~     xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ;~     (9) quality of life.~   "
43389|NCT02489071|"~     This study evaluates the feasibility and utility of two behavioural programs designed to~     reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of~     participants will complete training in either program, with the remaining third a wait-list~     control group.~   "
43474|NCT02487953|"~     The purpose of this research study is to determine whether combining electronic nicotine~     delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared~     to either treatment alone.~   "
43390|NCT02489058|"~     This is an observational and sample collection study involving patients (alive or deceased)~     from several clinical trials who had received the investigational drug, olaparib in other~     research studies. There is no intervention given for this study.~      This research is being done to understand of the mechanisms involved in patients whose~     cancer responds well and whose cancer does not respond well to investigational drug,~     olaparib, to help better understand how olaparib works and to better identify patients who~     may benefit from this therapy.~   "
43391|NCT02489045|"~     This is an open-label, non-randomized trial that will be conducted at two clinical sites,~     Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP).~     Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient~     (HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo,~     Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound~     imaging will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare,~     Milwaukee, WI) and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be~     used to measure pressure values in the hepatic and portal veins. Data will be stored on a PC~     and compared to pressure-catheter measurements, Subjects identified in the initial~     examination as having portal hypertension (by HVPG results) will be monitored by SHAPE for~     up to 18 months. These subjects typically have surveillance Computed tomography (CT) or~     magnetic resonance imaging (MRI) scans every 6 months to screen for liver cancer, and at~     those times a repeat SHAPE examination will be performed (ideally within 1 month of their~     clinically indicated imaging follow up appointment). In patients who undergo more frequent~     screening (generally 3 month intervals), SHAPE exams will be performed at 6 month intervals.~     Any repeat trans-jugular liver biopsies performed in this population will also trigger a~     repeat SHAPE study. Results of blood test evaluations (performed every 3 months in this~     population), medication, concomitant imaging study or procedure (including endoscopies) will~     be noted (all blood tests and imaging are clinically indicated only and are not required by~     this protocol). The end point for this part of the study will be any one new complication~     (e.g., liver cancer) or a marked worsening in any complication, liver transplantation,~     death, or the end of this clinical trial (after 3 years). The investigators expect these~     patients will be monitored three times during the course of this clinical trial. The time to~     reach the end point will be noted if a new complication or a marked worsening in any~     complication occurs.~   "
43392|NCT02489032|"~     The goal of the proposed research is to complete the development of a web-based program to~     train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health~     organization (MBHO) practitioners to conduct screening, brief intervention, and referral to~     treatment (SBIRT) for problem alcohol use among working adults.~   "
43393|NCT02489019|"~     Hypotension is frequently encountered after induction of general anesthesia. It can be~     pronounced in elderly patients and can require administration of vasopressor agents~     including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged~     episodes, can contribute to an increase in morbidity and mortality in the postoperative~     period as suggested by some former studies. The investigators hypothesize that fentanyl can~     contribute to the decrease in blood pressure (BP) that is seen after induction of general~     anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the~     sympathetic nervous system.~      This study will be the first one to examine the effect of fentanyl administration on blood~     pressure in elderly patients with induction of general anesthesia prior to the start of~     surgery. If the study shows that fentanyl contributes to hypotension during this period, it~     may lead to a change in practice and better patient outcomes and mortality rates.~   "
43394|NCT02489006|"~     This is a study that will look at the effects and how useful investigational drug olaparib~     is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main~     treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or~     fallopian tube cancer.~   "
43395|NCT02488993|"~     This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and~     duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients~     receiving other therapies.~      This registry study aims to comprehensively and rigorously characterize the impact of~     rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and~     quality of life in patients with HE in Europe and Australasia.~   "
43396|NCT02488980|"~     This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy~     of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of~     P. falciparum in Nyanza Province, western Kenya.~   "
43397|NCT02488967|"~     This randomized phase III trial studies how well doxorubicin hydrochloride and~     cyclophosphamide followed by paclitaxel with or without carboplatin work in treating~     patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and~     cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and~     carboplatin in treating triple-negative breast cancer.~   "
43398|NCT02488954|"~     Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that~     results at least in part of an abnormal immune response to environmental factors including~     the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to~     provide health benefits when consume) may restore the gastrointestinal microbiota and reduce~     intestinal inflammation.~      Propionibacterium freudenreichii is used for the production of fermented food products~     (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese~     based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii~     may decrease disease activity during ulcerative colitis.~   "
43399|NCT02488941|"~     Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic~     liver disease in the western world and an important cause of morbidity and mortality~     including risk of cardiovascular disease. A ruling dogma is that a fatty liver is~     well-functioning. Recent studies imply the contrary but quantitative measurements of~     metabolic liver function have not been systematically investigated in NAFLD.~      Objectives: To study and quantify specific metabolic liver functions in varying degrees of~     NAFLD. Furthermore to map the coagulation system of patients with NAFLD.~      Methods: A human clinical study. Metabolic liver functions are studied by a series of~     functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT),~     Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance~     (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal)~     PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary~     and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.~      Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in~     NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD,~     histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant~     imbalance in NAFLD.~   "
43400|NCT02488928|"~     EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute~     deformation of the node by the beating heart. Whether EBUS elastography may further increase~     the sensitivity to predict the presence or absence of malignancy is unclear.~      We suggest to use EBUS elastography strain pattern analysis for this assessment and~     correlate these measurements with the final pathology outcome to determine NPV, PPV,~     sensitivity and specificity of this analysis to predict the presence or absence of~     malignancy in patients with (suspected) lung cancer in a prospectively obtained~     observational cohort study.~   "
43401|NCT02488915|"~     The study objective is to examine the recanalization efficacy of the EmboTrap device and its~     associated performance characteristics and to record associated clinical outcomes in a~     manner that facilitates relevant comparison of outputs with that of devices approved in the~     U.S. for clearing Large Vessel Occlusions.~   "
43402|NCT02488902|"~     This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a~     range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as~     chemosuppression of P. falciparum malaria. Medications and placebo were matched and a~     double-dummy technique enabled blinding of tafenoquine versus mefloquine.~   "
43403|NCT02488889|"~     This laboratory study will examine if varenicline can reduce alcohol-induced smoking lapse~     in heavy drinking smokers.~   "
43404|NCT02488876|"~     The aim of this study is to collect non-individual related blood samples for the compelling~     of a unique database of tissue samples to understand the inflammatory responds after cardiac~     surgery on an on-going basis. This includes especially protein analyses and genetic testing~     for certain neurotransmitters in the blood and tissues to understand disease markers related~     to heart disease. The study is designed as an openly recruiting biobank with the purpose to~     later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing~     for neurotransmitters in the blood and tissues.~   "
43405|NCT02488863|"~     Osteoarthritis (OA) represents the leading cause of disability worldwide, and the knee is~     the most commonly affected joint. Knee OA has been traditionally attributed to peripheral~     mechanisms, but peripheral damage, inflammation, and psychological factors have failed to~     significantly account for the presence, absence, or severity of chronic OA-related pain.~     Recent studies show that individuals with OA-related pain exhibit dysfunctional pain~     modulation supporting a significant central nervous system (CNS) contribution. However, the~     CNS mechanisms underlying these changes in pain modulation are not currently known, nor~     their relation to clinical pain progression. The proposed pilot examines brain circuits~     recently described in predicting the transition from acute to chronic pain, in predicting~     clinical and experimental pain changes as well as physical performance and mobility changes~     in older persons with knee OA pain over a one year period. The findings will provide novel~     and important information regarding the mechanisms underlying aberrant pain processing and~     its functional consequences in older adults with knee OA. The information learned can be~     subsequently used to target treatment and prevention strategies in future studies of older~     adults. The central hypothesis is that increased functional and structural connectivity of~     cortico-striatal regions will be significantly associated with baseline clinical and~     experimental pain and decreased physical function in persons with symptomatic knee OA and~     will account for more rapid clinical pain and disability progression overtime.~   "
43406|NCT02488850|"~     Rationale: An anatomical surgical resection is considered to be the standard of care in fit~     patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery~     is less frequently performed in both elderly patients (aged ≥75 years), who represent the~     fastest-growing group of patients with stage I/II NSCLC, and in patients who have~     significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy~     (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the~     median survival of all elderly patients undergoing radiotherapy in The Netherlands increased~     by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and~     results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A~     recent data retrospective study comparing both modalities has raised interesting questions~     about the impact of local therapy on recurrence patterns. It was found that a better~     loco-regional disease control rate was achieved with SABR.~      Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary~     endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients~     with early stage non-small cell lung cancer who are treated with either modality.~      Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven~     NSCLC.~      Main study parameters/endpoints: To determine whether an increase in CD8 activity can be~     established after SABR in patients with early stage lung cancer and to compare this increase~     with that in patients undergoing a surgical intervention. Nature and extent of the burden~     and risks associated with participation, benefit and group relatedness: Only risks in~     participation are the risks with drawing blood. Subjects will not have any benefits. This~     pilot study will be used to generate information concerning both treatments useful for the~     decision to plan a future study in a larger series of patients.~   "
43407|NCT02488837|"~     The purpose of the study is to determine if non-invasive measurements of brain waves from~     the skin called electroencephalography (EEG) can predict whether the brain stimulator will~     help your symptoms. Our goal is to obtain these brain wave measurements with patients both~     awake and under general anesthesia, and then to evaluate which brain wave patterns are~     associated with clinical improvement to determine if they could be useful for predicting~     whether the surgery will work. If such predictive measures were established based upon the~     findings of this study, they could be used in the future to improve surgical outcomes in the~     following ways: (1) to help guide surgical targeting in the operating room awake or under~     anesthesia, (2) to guide post-operative programming in clinic, and (3) and to develop~     potential feedback systems for automatic programming of the brain stimulator system at~     home.~   "
43408|NCT02488824|"~     The ability to maintain normal body temperature (Tcore) is impaired in persons with~     tetraplegia: subnormal Tcore and vulnerability to hypothermia (<95°F) have been documented~     in this population after exposure to even mild environmental temperatures. However, no work~     to date has addressed the effect of subnormal Tcore on cognitive performance in persons with~     tetraplegia despite studies with able-bodied (AB) individuals that have documented~     progressive decline in various aspects of cognitive performance associated with the~     magnitude of the depression in Tcore. The investigators' study will confirm and extend their~     initial observations in persons with higher cord lesions who have subnormal Tcore to show~     that cognitive performance will be improved by raising Tcore to euthermic levels. This~     improvement should be associated with greater function and independence, reintegration into~     society, and an improved quality of life.~      Specific Aims: During exposure to 95°F for up to 120 minutes in the seated position, the~     investigators' aims are:~      Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a~     positive effect on cognitive performance (attention, working memory, processing speed, and~     executive function) in persons with higher-level spinal cord injury (SCI).~      Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will~     demonstrate an increase of 1°F in Tcore, while none of the AB controls will demonstrate such~     an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in~     Stroop Interference scores (a validated measure of executive function), while none of the AB~     controls will demonstrate a change in cognitive performance.~      Secondary Specific Aim: To determine changes in: (1) The average of distal skin~     temperatures; (2) Sweat rate; and (3) Subjective rating of thermal sensitivity.~      Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal~     skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity~     compared to that of AB controls.~   "
43410|NCT02488785|"~     The goal of this study is to evaluate the impact of a comprehensive diabetes education and~     management program based on frequent communication with patients using teleconsultation,~     text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2~     diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the~     baseline and the six-month visit will be at least 0.5 percent greater in the intervention~     group than in the control group.~   "
43411|NCT02488772|"~     Background The emergency department is a chaotic place with high levels of noise and light~     24 hours a day. Patients are often boarded overnight while they await tests or consultations~     scheduled for the morning. Sleep deprivation, high noise levels have been associated with~     negative patient experiences and outcomes in other clinical settings. Interventions to~     counter the effects of noise and light in the emergency department for patients staying~     overnight have not been investigated.~      Objective To determine if sleep and other aspects of the patient experience can be improved~     for patients boarded overnight in the Emergency Department with the use of a sleep mask and~     ear plugs.~      Methods A randomized control study will take place in the Emergency Department of Kingston~     General Hospital. Eligible patients will randomized to receive either sleep aids (sleep mask~     and ear plugs) or standard treatment (no sleep aids). The primary outcome will be sleep~     quality, assessed by Richards-Campbell Sleep Questionnaire. Secondary outcomes include~     patient satisfaction, hours of sleep, blood pressure, heart rate, new-onset delirium,~     patient's sense of feeling well-rested and patient overall sense of well-being. The primary~     analysis will be intention-to-treat comparing primary and secondary outcomes between the two~     groups in an unadjusted fashion. A secondary analysis will involve linear regression to~     explore the association between treatment group and Richards-Campbell Sleep Score,~     controlling for potential confounders.~      Importance Determining the feasibility and efficacy of sleep masks and earplugs for patients~     in the emergency department to improve sleep and the patient experience has never been done~     before. If found to be effective, this relatively low- cost intervention could be~     implemented in emergency departments across the country and around the world.~   "
43412|NCT02488759|"~     The purpose of this study to investigate the safety and efficacy of using nivolumab, and~     nivolumab combination therapy, to treat subjects who have virus-associated tumors. Certain~     viruses that infect human cells have been known to play a role in tumor formation and~     growth. This study will investigate the effects of the study drugs nivolumab, and nivolumab~     in combination with ipilimumab, BMS-986016 or daratumumab in human subjects who have the~     following types of tumors: Epstein Barr Virus (EBV) positive gastric cancer; EBV positive~     nasopharyngeal cancer (NPC); Human Papilloma Virus (HPV) positive cervical, vaginal, vulvar~     cancer; Other HPV-associated tumors (anal canal, penile), HPV positive squamous cell cancer~     of the head and neck (SCCHN); and Polyomavirus positive merkel cell cancer.~   "
43413|NCT02488746|"~     Prospective observational trial. A full thickness resection of gastric subepithelial tumors~     is performed after application of full thickness sutures underneath the tumor with the~     GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.~   "
43414|NCT02488733|"~     Bariatric surgery is efficient in both inducing adequate weight loss and the control of~     glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).~      Despite growing evidence suggesting that early performance of bariatric surgery on obese~     patients with T2DM offers the best opportunity to reach and maintain a remission of~     diabetes, no randomized clinical trials (RCT) have evaluated its efficiency in patients with~     new T2DM diagnosis.~      The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve~     Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM~     diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited~     at two Italian diabetology centres (Terni and Rome).~      The main objective of the present RCT is to investigate the efficacy of LSG as compared with~     CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%,~     without active pharmacologic therapy or ongoing procedures) and the remission of T2DM~     through the evaluation of the criteria provided by the American Diabetes Association (ADA)~     at maximum follow-up of 6 years. The effects of the two treatments in terms of weight loss~     and the quality of life of the patient will also be taken into consideration.~      Any positive results of this study will include preventing microvascular and macrovascular~     complications connected with diabetes, without the necessity to take medication, and at the~     same time the loss of excess body weight and improved quality of life (QOL).~   "
43415|NCT02488720|"~     The LEARN study a multicenter, observational study will that will evaluate the rate of~     cognitive change in approximately 500 clinically normal older individuals who screen-fail~     for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of~     elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility~     criteria. This study will leverage the A4 infrastructure and maximize the data acquired in~     screening a large number of well-characterized older adults for the A4 trial.~      The LEARN observational cohort will provide a critical comparison group for the A4 placebo~     arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest~     that older individuals with elevated Aβ burden are at increased risk of cognitive decline,~     it is important to demonstrate a differential rate of clinical decline between Aβe (Aβ~     elevated) and Aβne (Aβ not elevated) individuals on a standardized set of clinical~     outcomes. Over 2000 well-characterized, highly motivated older volunteers will screen fail~     for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely~     as possible to the two treatment arms, in this observation cohort. The LEARN study may~     selectively recruit from a specific range of SUVr that fall below the threshold for~     elevated amyloid in order to support analyses of the relationship of baseline SUVr to~     subsequent cognitive change and amyloid accumulation. The observational cohort will be~     followed for 168 weeks with identical clinical/cognitive testing performed every 24 weeks,~     running parallel to the A4 treatment study.~   "
43416|NCT02488707|"~     A prospective study is planned for management of low rectal cancer with the aim of sphincter~     preservation and improving the oncological outcome of the patients, through comparing of~     both approaches minimally invasive techniques including transanal total mesorectal excision~     and laparoscopic intersphincteric resection.~   "
43417|NCT02488694|"~     This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance~     following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal~     growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after~     first-line treatment with afatinib with respect to progression-free survival.~   "
43418|NCT02488681|"~     Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to~     the Micra System while the marketing application is under review by the Food and Drug~     Administration (FDA).~   "
48011|NCT02428608|"~     The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified~     Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated~     with corrugator and procerus muscle activity in adult subjects.~   "
43419|NCT02488668|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might~     be elicited or worsened by a range of physical factors (e.g. changes in the weather or~     pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well~     known that most treatments available for PLP today, such as pharmacological, surgical,~     anaesthetic, psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical~     reorganization and alleviation of phantom limb pain has been observed in amputees following~     intense use of a hand prosthesis. However, there is no consistent knowledge on which type of~     peripheral sensory feedback may be effective in affecting the cortical plasticity or on how~     to best apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
43420|NCT02488655|"~     This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with~     the FastScan version using assessment of patient experience and adverse event reporting.~   "
43421|NCT02488642|"~     The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide~     dinitrate-oxytocin in combination in the management of late intrauterine foetal death.~   "
43422|NCT02488629|"~     To evaluate the safety and efficacy of SCB01A in head and neck cancer.~   "
43423|NCT02488616|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and sensor-augmented pump therapy to regulate~     glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.~      The investigators hypothesized that dual-hormone closed-loop strategy will reduce the time~     spent in hypoglycemia compared to single-hormone closed-loop strategy, which in turn will be~     more effective than sensor-augmented pump therapy to reduce time spent in hypoglycemia.~   "
43424|NCT02488603|"~     This is an educational intervention study for breast cancer patients who undergo tamoxifen~     treatment. The purpose of the study is to assess the impact of decision aids (DA) on the~     patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen~     treatment. Patients will randomly assign to DA group or conventional group. Both groups will~     have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later~     follow-up questionnaire surveys.~   "
43425|NCT02488590|"~     The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap~     syndrome has been defined based on the concurrence of asthma and COPD characteristics. These~     characteristics are based on expert opinions and have never been investigated nor validated~     prospectively.~      The investigators assume that the management strategy, the symptom burden and disease~     progression will differ between asthma, COPD and ACOS. Therefore, the study wants to~     establish baseline criteria for an appropriate disease definition and evaluate the potential~     impact on treatment and symptom control.~   "
43426|NCT02488577|"~     Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive~     total mesorectal excision or transanal minimally invasive locoregional resection.~   "
43427|NCT02488564|"~     It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and~     potential early predictors of response in neoadjuvant setting. Patients with operable breast~     cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer~     (T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are~     included in the study.~      The primary objective is to evaluate the pathological complete response rate (pCR).~      The secondary objectives are:~        -  to evaluate the clinical response rate (RR).~        -  to evaluate the feasibility and systemic tolerance, with particular attention to~          cardiac toxicity.~        -  to evaluate the conservative surgery rate.~      Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At~     every cycle (every 21 days) will be administered:~      Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:~     Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first~     infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin~     is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be~     administered once a day; from day -10 Metformin 1000 mg will be administered twice a day~     continuously until end of the study treatment.~   "
43428|NCT02488551|"~     Background and Significance: Randomized Controlled Trials (RTCs) have demonstrated that~     evidence-based psychotherapies (EBPs), particularly Cognitive Behavioral Therapy (CBT), are~     highly effective in treating anxiety and depression, the most common mental health disorders~     in primary care settings. Mental health (MH) providers in VA~     Community-Based-Out-Patient-Clinics (CBOCs) are often located in rural areas and isolated~     from educational opportunities. Almost half of Veterans now use CBOCs. Studies have shown~     that the quality of delivery of EBPs (fidelity) impacts clinical outcomes. This study will~     test a computer-assisted tool (CALM Tools for Living) that increases fidelity to CBT in~     treating depression and four common anxiety disorders, including PTSD. Although results of a~     large RCT, the CALM study, suggested that the tool contributed to fidelity to the CBT~     protocol, this hypothesis has not been tested. This study will test the tool in primarily~     rural CBOCs in VA VISN16.~      Objective: To modify a computer-assisted CBT tool to meet the needs of CBOC MH providers and~     Veterans, to evaluate the impact on providers' fidelity to the CBT model and clinical~     outcomes, and to assess how best to support future implementation.~      Specific Aims/Hypothesis: (1) Engage CBOC MH providers in modifying the computer-assisted~     CBT tool such that its content is relevant and acceptable to Veterans and providers. The~     investigators hypothesize that the modified tool will be acceptable to both Veterans and~     providers. (2) Compare MH provider fidelity to CBT and clinical outcomes among providers who~     used the tool and those who did not. The investigators hypothesize that clinicians who use~     the tool will have a higher fidelity to CBT and clinical outcomes among patients will be~     superior. (3) Prepare for future implementation of the tool in the VA.~      Methodology: This study will use a Type III hybrid effectiveness design. Methods common to~     the field of Instructional Design and Technology (IDT) will be used to modify the tool.~     Thirty-four CBOC MH providers will be trained in CBT and randomized to use the tool or not.~     Both groups will receive external facilitation to encourage the full implementation of CBT~     into practice on the clinic level. MH providers will treat 10 patients each. Patients will~     be assessed at baseline, 3, 6, and 12 months. Provider fidelity to the CBT protocol will be~     measured, and finally, a tool kit for future implementation of the tool will be~     disseminated.~      Impact: The investigators expect the intervention to improve the technical quality of MH~     treatment in CBOCs and improve clinical outcomes among Veterans.~   "
43511|NCT02487472|"~     The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic~     neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources~     used, medical direct and indirect costs, as well as pain severity and impact on quality of~     life.~   "
43429|NCT02488538|"~     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using~     computer generated random numbers. Group 1 will receive COC containing drospirenone~     (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® ScheringAG, Egypt) daily for 21 days~     starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group~     2 will receive COC containing drospirenone daily for 21 days starting from the 3rd day of~     menstruation in addition to a daily oral placebo similar in size, color and structure to~     fluoxetine . Group 3 will receive oral placebo similar to COC daily for 21 days starting~     from the 3rd day of menstruation in addition to a daily oral placebo similar in size, color~     and structure to fluoxetine.~   "
43430|NCT02488525|"~     Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor~     concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD)~     reduces the frequency of clinically significant bleeding within 3 months after implantation~     in comparison to the usual care. Adult patients with functional defects of VWF measured~     after implantation of continuous LVAD are randomly assigned to prophylactic treatment.~   "
43431|NCT02488512|"~     This is a prospective, single arm,single centre open-label, phase II study in relapsed or~     refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies,~     included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous~     stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with~     90Y-Dotatoc.~      Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi),~     divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 -~     8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.~      35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if~     2 or fewer patients will show an objective response, the study will be closed).~   "
43432|NCT02488499|"~     This study investigates the effectiveness of a clinic-adapted version of the Coping Power~     program compared to individualized child and family treatment for children with disruptive~     behaviour and their parents.~   "
43433|NCT02488486|"~     This pilot study evaluates the effectiveness of a closed-loop administration of propofol and~     remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.~   "
43434|NCT02488473|"~     Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the~     duration of an adductor canal block. By using healthy volunteers the investigators can~     perform a bilateral adductor canal block and thereby control for a systemic effect to~     clarify if the effect is actually peripheral or systemic. The investigators hypothesis is~     that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a~     peripheral nerve block by a peripheral mechanism.~   "
43435|NCT02488460|"~     Background~      Increased physical activity can improve cognition and academic skills. However due to~     economic concerns and increasing focus on standardized testing, PA in schools often receives~     little attention and physical education is reduced in many countries in favor of spending~     more time devoted to academic classes. This tendency is not compatible with the increasing~     evidence for the association between physical activity, fitness, cognitive and academic~     performance.~      Despite increasing evidence for the association between PA, fitness, cognitive and academic~     performance, very few longitudinal high-quality studies exists examining the effect of~     physical activity on academic performance (ref.). Furthermore, to the best of our knowledge~     only two studies have assessed academic outcomes following the integration of physical~     activity into the classroom with intervention participants scoring significantly higher in~     test sections compared to controls which makes generalizing from these results challenging.~      To promote policy changes that require more physical activity in school, empirical data are~     needed to study the effects of school-based physical activity programs. Therefore the~     investigators carried out a cluster randomized controlled trial conducted to examine the~     effect on math achievement and executive functions of classroom based PA in math.~   "
43436|NCT02488447|"~     The purpose of ths study is to evaluate changes in life quality of patients affected by~     rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an~     observational, prospective and comparative study before-after immunotherapy treatment with a~     one year follow-up.~   "
43437|NCT02488434|"~     The aim of the current study is to evaluate to effectiveness of sperm selection by using~     fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI)~     cycles.~   "
43438|NCT02488421|"~     The purpose of this study is to determine and compare the persistence rate of newly~     prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.~   "
43439|NCT02488408|"~     Multicenter open-label study of BGB324 as a single agent and in combination with cytarabine~     in patients with acute myeloid leukemia. BGB324 is a potent selective small molecule~     inhibitor of Axl, a surface membrane protein kinase receptor which is overexpressed in up to~     half of AML cases.~   "
43440|NCT02488395|"~     The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier~     Parkinson's disease, using the superior colliculus as a biomarker.~      Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest~     that the superior colliculus, a sensory structure, show an early deficit in visual~     processing. The investigator's data also suggests that with the evolution of the disease,~     this structure presents a neuronal re-organisation leading which causes a sensory rebound~     after the introduction of the treatment. The light responses in the superior colliculus were~     faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an~     important question about the superior colliculus functional state in Parkinson's patients.~     If this structure have a similar neuroplasticity, the investigators could hypothesize that~     the superior colliculus may also present a sensory rebound when introducing the treatment.~     If this hypothesis is true, the accelerated and amplified light responses of this structure~     may explain the difficulties felt by the patients to inhibit reflexive saccades induced by~     the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in~     the orientation of the head and eye toward any sudden changes in our environment (Wurtz and~     Albano, 1980) and the light responses of this structure are strongly correlated with the~     speed of the saccade (Marino et al., 2012).~      Therefore, the investigators want to test if a similar deficit could be observed in the~     superior colliculus of newly diagnosed PD patients. Data will be compared to matching~     controls.~   "
43442|NCT02488369|"~     This is a diagnostic prospective multicenter study. This study will be conducted in 32~     centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent~     (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the~     SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated~     with conventional imaging time of remission assessment. Histological examination of residual~     tumor will be conducted whenever practicable in patients with pathologic residual image on~     conventional imaging and / or PET / CT. A central review of conventional imaging~     examinations and PET / CT will be performed independently from each other.~      Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET /~     CT (between J8 and J28 according to the type of lymphoma and toxicities due to treatment).~     The results of the early PET / CT should not lead to treatment modifications.~      In case of residual tumor at remission assessment, therapeutics changes as recommended~     therapeutic protocols will be based on histologic findings and not on the results of PET /~     CT alone.~   "
43443|NCT02488356|"~     Safety and Efficacy of Litramine in weight loss.~   "
43444|NCT02488343|"~     Adherence is an active process wherein the patient acts in collaboration with the medical~     and paramedical staff in order to improve his/her health. Adherence to medication comprises~     of implementation and persistence and it is estimated to be around 50% in various chronic~     illnesses, including Multiple Sclerosis (MS). MS patients who fail to properly adhere to~     their DMTs regimen may be at increased risk for the development of new central nervous~     system lesions, exacerbations, increased disabilities and poorer quality of life. Plausible~     reasons for the low adherence rates in MS mentioned in the literature include patients'~     attributes, condition attributes and therapy related factors.~      The objective of this study is to develop a personal profile of adherence based in the~     factors mentioned above. In the first part of the study patients will be followed up and the~     profile My Multiple Sclerosis Perception Adherence Scoring System (MyMS_PASS) will be~     created and tested. In the second part, patients with non-optimal rates of adherence will~     receive tailored intervention in order to improve therapy to treatment. This work may serve~     as a model for the study of adherence to therapy and the development of interventions in MS~     as well as in other chronic diseases.~   "
43445|NCT02488330|"~     This extension study will provide continued onartuzumab and/or parent trial (P-trial)~     designated control treatments to participants with cancer who were previously enrolled in a~     company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the~     responsible investigator, from the therapy administered in the P-trial. The study will also~     collect safety data with regard to administration of continued onartuzumab therapy.~   "
43446|NCT02488317|"~     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to~     identify factors that matter the most to patients with kidney disease and study how they are~     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient~     advocacy organizations as research partners will assure that the study addresses questions~     of greatest relevance to patients facing the need for dialysis.~      For Aim 3, the investigators are going to compare measures related to the decision-making~     process between patients receiving and not receiving a decision aid focusing on Peritoneal~     Dialysis and Hemodialysis.~   "
43447|NCT02488304|"~     The objective of this study is to detect BOS in an early stage by using the outcome~     parameters generated by Functional Respiratory Imaging (FRI). Robust and automated~     segmentation algorithms will be developed for these parameters, focusing on quantitative~     computed tomography (CT) image analyses to provide the physician a more sensitive~     diagnostics tool. The evolution of rejection over time will be monitored using non-rigid~     image registration methods.~   "
43448|NCT02488291|"~     The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor~     in primiparas so as to decrease perinatal complications of analgesia labor.~   "
43449|NCT02488278|"~     The GlucoMe device, in its original packaging, along with the user manual and QuickStart~     guide will be provided to the patient in a simulated home use environment. The patient~     labeling will be in the format intended for distribution.~      Ten (10) subjects identified as potential end users of the GlucoMe device will receive the~     user manual. An additional ten (10) subjects also identified as potential end users of the~     GlucoMe device will NOT receive the user manual. All subjects will be provided with a~     pre-test and post-test questionnaire and a list of tasks to complete, including applying and~     operating the device.~      The observer and user post-test questionnaire will collect information regarding device use.~     The device's use will be compared with identified risks to determine if the percentage of~     failures is within the study protocol success criteria. Additionally, measurable usability~     criteria for specific, critical steps will be evaluated.~   "
43450|NCT02488265|"~     Postural instability is a particularly incapacitating disorder, where loss of motor~     independence by Parkinson´s Disease (PD) patients marks a significant stage of disease~     onset. Evidence suggests that deficits in automatic motor control, sensory integration and~     attention are associated with lack of balance in PD. Physiotherapy, together with~     medication, plays an important role in the treatment of this state, although no consensus~     has been reached on the best treatment modality. The aim of this randomized controlled trial~     protocol is to evaluate the effects of balance training with rhythmical (BRT), which is a~     motor program to improve balance associated with rhythmical auditory cues (RACs)~   "
43451|NCT02488252|"~     This study aims to explore the effect of an adjuvant semi-individualized Chinese medicine~     treatment plan on type 2 diabetic patients with stages 2 to 3 chronic kidney disease and~     macroalbuminuria. This study will collect preliminary data on treatment effect, variance,~     recruitment rate and attrition rate for the planning of a subsequent clinical trial.~   "
43452|NCT02488239|"~     The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the~     performance of the Ingenio 2 CRT-P devices and to document that device-related events,~     device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2~     CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the~     devices.~   "
43512|NCT02487459|"~     This is an open-label, non-randomized study to evaluate the safety of two planned infusions~     of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with~     hematologic malignancies.~   "
43453|NCT02488226|"~     This project seeks to understand how the gaze behavior of infants and children with or at~     high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic~     social and non-social scenes. The study explores not only the methods which may be most~     effective in aligning and teaching normative patterns of scene exploration, but also seeks~     to establish what behavioral characteristics may be most predictive of atypical scanning and~     atypical learning.~   "
43454|NCT02488213|"~     Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in~     Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a~     nutritional counseling directed to offer benefits in metabolic control in diabetic patients.~   "
43455|NCT02488200|"~     The present study plans to delineate the clinical, biochemical, sociological and~     psychological factors. involved in dialysis preparation, and their impact on dialysis~     initiation (DI), modality choice and prognosis. In particular the following questions are to~     be answered.~        1. What factors influence unplanned DI?~        2. What factors influence choice of dialysis modality?~        3. What factors influence choice of dialysis access?~        4. Why do physicians start dialysis?~        5. What factors in the predialytic period and its immediate aftermath (the peridialytic~          period) influence prognosis?~   "
43456|NCT02488187|"~     Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging~     (MRI) in Newly Diagnosed Breast Cancer Patients.~   "
43457|NCT02488174|"~     Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the~     most common form of acute organ dysfunction in the hospital, and is often associated with~     multiple organ failure (MOF), high mortality, and functional impairment. Most studies on ARF~     have focused on patients in the intensive care unit (ICU) after they have been on mechanical~     ventilation for days and end organ damage is already established. The overall goal of this~     proposed project is to improve the outcomes of patients at high risk for developing severe~     ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to~     intervene early in high risk patients with an electronic medical records (EMR)-based,~     patient-centered checklist of common critical care practices aimed at preventing lung injury~     and hospital acquired adverse events that commonly lead to organ failure (Prevention of~     Organ Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered~     randomized control trial to determine the utility of PROOFcheck to improve survival and~     reduce the duration of mechanical ventilation and multiple organ failure in patients~     identified as high risk for progressing to severe ARF and prolonged mechanical ventilation.~     The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction~     Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged~     Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital~     who are at high risk for developing severe ARF requiring mechanical ventilation >48 hours;~     2) to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit~     lung injury, prevent adverse events, and avoid additional organ failure; and 3) to establish~     the infrastructure for the proposed trial. The proposed pragmatic trial will harness the~     hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation~     with APPROVE for intervention with PROOFcheck. As such, the proposed trial aims to break out~     of the clinical silos by which care is currently organized in the hospital and bring~     patient-centered, context appropriate care to the acutely ill patient wherever and whenever~     the patient's condition requires it.~   "
43458|NCT02488161|"~     Coordinated multi-center project with several complementary goals in each one of the~     sub-projects included. Objectives: 1.To determine risk factors of death, or major~     complications in the short term; 2.To determine risk factors of death, tumor recurrence,~     major complications, readmission or deterioration of quality of life in the mid term;~     3.Evaluation of patient reported outcomes from before the intervention to the end of the~     follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar~     adverse results. This sub-project (coordinator) will approach the determination of risk~     factors of death, tumor recurrence, major complications, readmission and deterioration of~     quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with~     2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6~     Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically~     intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic,~     immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to~     study. Statistic analysis: a derivation sample will be created where the possible predicting~     parameters will be identified, by cancer of colon or rectum. Predictive models will be~     created with a good discriminative capacity. A validation of those models will be performed~     in a validation sub-sample. Logistic and Cox regression models will be used. Simulation~     models for the prediction of discreet events in the long term will be used.~   "
43459|NCT02488148|"~     Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing~     to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction~     are emerging risk factors for cardiovascular disease and predict future cardiac events.~     Vascular function has long been a target for lifestyle interventions with several studies~     showing improvements traditional exercise modes. However, the impact of yoga on vascular~     function remains elusive. This study will determine the effect of a 12-week Bikram yoga~     intervention on arterial stiffness and endothelial function in healthy, middle-aged adults.~      The overall aim of this study is to determine the efficacy of Bikram yoga in improving~     vascular endothelial function and arterial distensibility in middle-aged adults with risk~     factors for coronary artery disease and to determine whether the heated environment plays a~     role in mediating these alterations in vascular function. The investigators propose to~     conduct a 12-week Bikram yoga intervention study in sedentary individuals in order to test~     the following hypotheses:~        1. Bikram yoga will elicit reductions in arterial stiffness and enhancements in~          endothelial function in sedentary, middle-aged adults.~        2. The postulated effects of Bikram yoga will be greater when practiced in a heated~          environment.~   "
43460|NCT02488135|"~     Nosebleeds that persist even after adequate traditional nasal packing may require aggressive~     treatment strategies to stop bleeding. Currently these strategies include a surgical~     approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix~     is a gel like medical therapy that is inserted into the nose and is engineered to stop~     bleeding in severe cases, possibly avoiding the need for surgery. In this study the~     investigators will randomize patients to either receive FloSeal Hemostatix matrix or~     traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be~     whether the investigators are able to stop bleeding with FloSeal or traditional packing~     alone and whether additional measures are necessary to stop the bleeding. The investigators~     will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal~     effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable~     for patients then it may be the favourable treatment.~   "
43513|NCT02487446|"~     The purpose of this study is to demonstrate that the efficacy of the combination product~     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a~     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.~   "
43461|NCT02488122|"~     Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is~     a major contributing factor associated with insufficiency fracture of the spine, wrist and~     proximal femur, and as a result, can diminish quality of life as well as increase direct and~     indirect healthcare costs.~      The pathophysiology of osteoporosis is based on two main factors; low bone mass and age~     associated architectural changes within the bone, high impact exercise in childhood can~     improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation~     to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of~     total body adult bone mass is accrued during this period.~      However, the optimal exercise program for increasing peak bone mineral content is still~     unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise~     three times per week improve areal bone mineral density assessed by DXA of pre pubertal~     girls after a ten-month regimen compared to low-impact exercise. This information could~     highly impact the development of public health policies directed to pre pubertal girls.~   "
43462|NCT02488109|"~     The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of~     lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with~     anorexia nervosa.~   "
43463|NCT02488096|"~     The purpose of this study is to determine if using MRI can improve cancer detection by~     identifying potential cancer targets prior to TRUS-guided biopsy in populations that have~     previous inconclusive results from TRUS-guided biopsies.~   "
43464|NCT02488083|"~     UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm,~     baseline-controlled clinical study for the evaluation of the UltraShape treatment for~     non-invasive fat and circumference reduction.~   "
43465|NCT02488070|"~     This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA)~     (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography~     (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying tumors~     in patients with prostate cancer that has come back after a period of improvement~     (recurrent). 68Ga-PSMA is a radioactive drug that may attach to specific prostate cancer~     cells and light up. Scanners, such as PET/CT or PET/MRI, can then be used to take pictures~     of the body to see where the cancer is. Using 68Ga-PSMA for PET/CT or PET/MRI may allow~     doctors to identify smaller tumors than standard methods.~   "
43466|NCT02488057|"~     This study will examine the benefits of weight loss alone or in combination with a GLP1~     receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA)~     women with prediabetes. The Investigators have chosen to focus on MA women because MA women~     are at very high risk for progression to diabetes and have not traditionally been involved~     in weight management studies since they are thought to be difficult to recruit and retain in~     such programs. However, investigators have had particular success in working with young MA~     women using specifically developed ethnic and gender conscious programs. Because weight loss~     does not prevent all progression to diabetes, some participants will receive the diabetes~     medication, liraglutide, which has been shown to stabilize beta cell function. The study~     will also interrogate for polymorphisms of known T2DM genes to correlate with beta cell~     response to weight loss and liraglutide treatment. Additionally, this investigation targets~     serious health disparities in metabolic disease in a highly vulnerable, rapidly growing~     population, testing novel gender and culturally focused intervention strategies and~     identifying genetic biomarkers of response to a pharmacologic intervention that targets the~     pancreatic ßcell.~      These results will help to a) understand mechanisms of disease, b) personalize treatment~     through identification of a high risk group that may be amenable to specific therapy, and c)~     ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic~     and costly disease, in Mexican Americans.~   "
43467|NCT02488044|"~     A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the~     Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is~     designed to evaluate the safety and tolerability of IV administration of AEB1102 for the~     treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia.~     This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part~     2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels.~     All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify~     for continued dosing. A data safety monitoring board (DSMB) will provide independent review~     of study safety data and recommend whether the sponsor should continue the study as planned,~     modify the study protocol, or discontinue the study.~   "
43468|NCT02488031|"~     The purpose of this research study is to investigate how the brain and motor behavior~     changes both in individuals with spinocerebellar ataxia and healthy individuals, and to~     assess whether a therapeutic intervention reduces levels of uncoordinated movement and~     improves motor function in spinocerebellar ataxia (SCA).~   "
43469|NCT02488018|"~     The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise~     the blood glucose level.~   "
43470|NCT02488005|"~     Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free,~     low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line~     imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and~     a small number of recent studies have looked at change in bowel wall thickness (BWT) in~     response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to~     detect response to anti-TNF therapy has not been tested in pediatric patients. The purpose~     of this study is to apply the use of SBUS to pediatric patients with Crohn's disease and to~     assess response to treatment with infliximab. The investigators will also measure C-reactive~     protein and fecal calprotectin at baseline, and additionally measuring IFX levels and~     anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to~     infliximab treatment, as well as correlation between these markers with changes in patient~     reported outcomes via a weighted pediatric Crohn's disease activity questionnaire (wPCDAI)~     and changes in BWT. This study is novel in that it will be the first study in pediatric~     patients to use SBUS to assess response to IFX therapy, and will also be the first study to~     correlate SBUS findings with therapeutic drug monitoring (TDM). This study has the potential~     to propagate the use of SBUS in the pediatric population, as the use of TDM in concert with~     small bowel imaging post-induction will allow the investigators to tailor therapy early in~     the treatment course.~   "
43475|NCT02487940|"~     The study will include 100 women with unexplained recurrent implantation failure undergoing~     IVF/ICSI cycle.~      Patients fulfilling the inclusion criteria will be randomised into two groups.~      Study Group:~      This group will include 50 women with unexplained recurrent implantation failure undergoing~     a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the~     day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and~     a final dose 2-3 weeks later when attending for pregnancy scan.~      Control Group:~      This group will include 50 women with unexplained recurrent implantation failure undergoing~     a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of~     oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final~     dose 2-3 weeks later when attending for pregnancy scan.~   "
43476|NCT02487927|"~     To evaluate the distribution of different types of difficult weaning and the predictive~     value of weaning relative factors.~   "
43477|NCT02487914|"~     Drug delivery is conducted through various methods such as injection, phonophoresis, and~     iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through~     epidermis using direct current. The direct current has some disadvantages such as skin~     burning and limited time of application. Interferential current is a kind of alternating~     currents without limitations of direct current; so the purpose of this study was to~     investigate and compare the effects of Lidocaine, interferential current and Lidocaine~     iontophoresis using interferential current.~   "
43478|NCT02487901|"~     Ultrasonic bone osteotome has been utilized in various surgical field, but the use in~     neurosurgery especially in spine surgery is not widely spread. In the present study, the~     investigators are going to compare bony fusion rate after cervical laminotomy either with~     ultrasonic osteotome or conventional drill.~   "
43479|NCT02487888|"~     The purpose of this study is to evaluate the impact of genetic testing on healthcare~     decisions and patient outcomes for patients suffering from pain, cardiovascular problems,~     Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will~     also be compared with the clinical outcome measures collected to discover novel genetic~     factors that may influence patient care.~   "
43480|NCT02487875|"~     Background: Individuals with COPD may present reduced peripheral muscle strength, which~     leads to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include~     strength training, in particular to lower limbs. Furthermore, simple tools for the~     assessment of lower extremity muscles' performance are required. Objectives: To assess the~     muscle strength of COPD patients by the sit-to-stand test (STST) as compared to the~     one-repetition maximum (1-RM), considered as the gold standard in non-laboratory situations,~     and to evaluate the responsiveness of STST to a PR program with specific strength training~     (SPR), compared to usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients~     were randomly included into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM~     and 6MWT were assessed before and after PRs.~   "
43481|NCT02487862|"~     Psychological conditions, particularly psychosocial stress, have been implicated as risk~     indicators for periodontal disease. Minimal evidence in literature exists to assess the~     effect of stress reduction therapy (SRT) in the outcome of non-surgical periodontal therapy~     (NSPT). Hence, the present study was aimed at exploring the possibility of employing SRT in~     stressed subjects (assessed using questionnaire data and serum cortisol level) as an~     adjunctive intervention in the management of periodontal diseases.~   "
43482|NCT02487849|"~     The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC~     with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic~     chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian~     carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts~     judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC~     will be administered additionally to standard therapy. If HIPEC was executed the number of~     systemic given platinum-based chemotherapy decreases for one cycle.~      This regime should be investigated in terms of safety of performance, quality of life for~     the patients and consequences for the following systemic chemotherapy.~   "
43483|NCT02487836|"~     For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on~     the endoscopic biliary stent. This technique has been shown to be preferable to a surgical~     shunt.~      Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized~     the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major~     way. This design will also be developed in patients with neoadjuvant tumor called~     borderline (the limit of the resectability).~      However, several conditions (protocol) are required to consider the implementation of this~     design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times~     the ULN.~      In addition, a randomized study showed that preoperative biliary stent treatment, despite a~     success rate of 94%, is associated with more complications than surgery fast (related~     gesture bladder).~      It would be interesting to analyze, prospectively, the fate of a series of patients with~     cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1~     and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.~   "
43484|NCT02487823|"~     To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in~     combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic~     prostate cancer.~   "
43485|NCT02487810|"~     The purpose of this study is to determine whether there are systematic differences between~     the decisions patients make intuitively versus deliberatively about life-sustaining medical~     therapies.~      The targeted population is inpatients at the Hospital of the University of Pennsylvania with~     serious medical problems. The study will involve facilitated interviews with patients using~     a survey instrument developed in Qualtrics.~   "
43486|NCT02487797|"~     Oxytocin is a medication that is often used to strengthen contractions to overcome delayed~     labor progress. The primary aim of this study is to determine whether receiving a higher~     dose of oxytocin lowers the chance of needing a cesarean section when compared to a lower~     dose of oxytocin. Other aims include examining the relationship between dose of oxytocin~     regimen and length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord~     gas, neonatal Apgar score <5 at 5 minutes, and need for neonatal intensive care.~   "
43487|NCT02487784|"~     The primary aims of this study are to compare the clinical and histologic results of bone~     regeneration with a cancellous block allograft versus MinerOss Cortico cancellous~     particulate allograft mixed with autogenous bone chips after 4 months of healing. Titanium~     reinforced hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts.~      Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and~     height.~      Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular~     space at 4 months.~      The primary outcome variable is the change in horizontal ridge width. The secondary outcomes~     are the change in ridge height and the percent histologic composition of the augmented site.~   "
43488|NCT02487771|"~     This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to~     follow-up with participants on the original study to determine if the effects of increasing~     DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.~   "
43489|NCT02487758|"~     Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless~     Approach to Grafting~   "
43490|NCT02487745|"~     The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of~     a Wage Supplement Model of arranging long-term exposure to employment-based abstinence~     reinforcement.~   "
43491|NCT02487732|"~     To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in~     type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring~     inflammatory markers, circulating number of endothelial progenitor cells, brachial artery~     endothelial function, and arterial stiffness.~   "
43492|NCT02487719|"~     Examination of iron supplements routinely used in pregnancy to compare these with one~     another regarding effectiveness in the prevention of iron deficiency.~      Determination of ferritin / hemoglobin every pregnant woman under the first routine check.~     Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron~     polymaltose, Group 3: multivitamin- multimineral) depending on the measured values.~     Repetition of hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1,~     additional provision of ferritin at the entrance to birth. In addition, registration of each~     child's birth weight and gestational age.~   "
43493|NCT02487706|"~     Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients~     with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed~     from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the~     end of HD sessions.~   "
43494|NCT02487693|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     ovarian carcinoma.~   "
43495|NCT02487680|"~     It has previously been shown in healthy overweight subjects, that table water including a~     defined amount of amino acids and chromium can decrease the postprandial glucose. In this~     study, the effect of this table water on glucose excursions after a test meal containing a~     defined amount of available carbohydrates, protein and fat will be studied in healthy~     subjects. The study will be conducted in a cross -over design, double blinded and placebo~     controlled including 20 participants. The primary endpoint of the study is the incremental~     area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the~     meal.~   "
43496|NCT02487667|"~     In adulthood, limited mobility and pain are very common and often the first clear sign of~     functional decline. The loss of independent mobility is related to higher rates of~     functional disability and mortality; however, it is also susceptible to interventions~     through exercises. With aging, changes in peripheral and central nervous system also occur,~     which lead to degradation of the sensory receptors as well as a loss of muscle mass and~     coordination. However, both, structural and functional dysfunctions of the nervous system,~     can be mitigated by increasing physical activity.~      The aim of this study is therefore, to study the effects on pain and functional capacity of~     a therapeutic exercise training program in an adult people sample. The therapeutic exercise~     machines proposed in this trial have not been previously analyzed and provide insight into~     this field due to their design. The design of this new machines allows the adaptation to~     each concrete clinical situation by the adjustment of different parameters such as feedback,~     range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor~     control training.~   "
43497|NCT02487654|"~     Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a~     patient's quality of life.~      Abnormal electrical activity from the 4 veins that drain into the left atrium (top left~     chamber of the heart), is the main cause of this condition. Catheter ablation and this~     involves making tiny burns within the left atrium that electrically disconnects these veins~     form the rest of the left atrium (pulmonary vein isolation). Abnormal electrical activity~     can be as a result of the nerves supplying the heart and destroying the collection of these~     nerve endings (ganglionic plexi ablation) can be helpful in eliminating the abnormal~     electrical activity. Catheter ablation for AF and study the affect of ganglionic plexi~     ablation on the success of this treatment option. All patients will be grouped by low or~     high preexisting scar. The investigators plan to recruit patients undergoing ablation with~     proportionate numbers in both existing scar groups. Patients will be randomly assigned into~     the two treatment groups each with different treatment strategies~        1. Pulmonary vein isolation alone~        2. Ganglionic plexi ablation alone There will be pre and post procedure tests as per~          optimal clinical practice. Some patients may require a repeat procedure if they have~          documented recurrence. This will be done after a minimum of 6 months. The~          redo-procedure will be pulmonary vein isolation for both groups with the ganglionic~          plexi arm receiving a lesions encircling the pulmonary veins. This will enable the~          study to report outcomes from 3 groups.~   "
43498|NCT02487641|"~     This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The~     hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.~   "
43499|NCT02487628|"~     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft~     Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ®~     Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable~     Lightweight Mesh.~   "
43538|NCT02487121|"~     This project examines the effects of differing schedules of extended care contact following~     weight loss treatment in order to prevent weight regain following treatment.~   "
43500|NCT02487615|"~     Subclinical atherosclerosis is the atherosclerotic process identified before clinical~     symptoms and thus it can be a useful marker of future cardiovascular events. It can be~     evaluated by many methods. This study included the diagnosis of subclincal atherosclerosis~     by four different methods: coronary calcium score, carotid doppler ultrasound to quantify~     intima media thickness and carotid plaques, exercise stress test and ankle brachial index.~     Clinical data, anthropometric measures (body mass index, abdominal circumference), markers~     of inflammation (high sensitive - C reactive protein, TNF alfa and Lipoprotein Associated~     Phospholipase A2), fat tissue function (leptin, resistin and adiponectin), glucose~     metabolism (fasting plasma glucose, glycated hemoglobin and insulin) and genetics markers of~     atherosclerotic process were evaluated as biomarkers of subclinical atherosclerosis in a~     uneventful population.~   "
43501|NCT02487602|"~     The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight~     loss device in vivo to further understand the device's mechanism of action in aiding weight~     loss.~   "
43502|NCT02487589|"~     Fall incidents are the third cause of chronic disablement in elderly according to the World~     Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk~     assessment and management programs are effective in all older population studied. However,~     the application of these programs may not be the same in all National health care setting~     and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this~     intervention in regular care. In Italy structured collaboration between hospital staff and~     primary care is generally lacking and the role of Information and Communication Technologies~     (ICT) in a fall prevention program at home has never been explored.~      This is a two-group randomized controlled trial aiming to evaluate the effect of a~     home-based intervention program, delivered by a multidisciplinary health team, in preventing~     falls in elderly. The home tele-management program, previously adopted in our Institute for~     chronic patients, will be proposed to elderly people affected by chronic diseases at high~     risk of falling at time of hospital discharge. The program will involve the hospital staff~     and will be managed thanks to the collaboration between hospital and primary care setting.~     Patients will be followed at home for 6 months after hospital discharge. A nurse-tutor will~     be the case manager and telephone support, telemonitoring and tele-exercise will~     characterize the intervention program. People in the control group will receive the usual~     care. The main outcome measure of the study will be the percentage of patients sustaining a~     fall during the 6-months follow-up period. An economic evaluation will be performed from a~     societal perspective and will involve calculating cost-effectiveness and cost utility~     ratios.~   "
43503|NCT02487576|"~     This human dietary intervention study with a cross-over design aims to investigate the~     effect of two different diurnal patterns of meal composition on peripheral circadian clocks~     and energy metabolism in healthy men.~   "
43504|NCT02487563|"~     Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to~     an increased risk of life-threatening hemorrhage, frequent requirement of platelet~     transfusions and extended hospital stays, representing a challenging clinical problem.~     Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet~     recovery and for preventing potentially fatal bleeding complications. Therefore, it is~     urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after~     HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may~     reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators~     conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and~     decitabine in the treatment of thrombocytopenia following HSCT.~   "
43505|NCT02487550|"~     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed~     with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a~     measurable immune response in patients with renal cell carcinoma, and to evaluate the~     clinical effect of the regimen.~   "
43506|NCT02487537|"~     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened~     soft drinks may play a role in the development of diabetes.~      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence~     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and~     even modulate incretin release.~      Data on human subjects are sparse and controversial, especially in a long-term manner. We~     therefore conduct a cross-over study to assess metabolic response to sweetened vs.~     non-sweetened soft drinks, which are consumed over a period of 4 weeks.~   "
43507|NCT02487524|"~     Investigators aim to identify the key phenotypes (biological, psychological, genetic)~     involved in the transition from acute to chronic neuropathic pain (NP) by comparison of the~     neuropathic pain phenotypes and genomics of patients developing NP or not under similar~     nerve injury conditions. The cohort is part of a previous prospective study of 1000 patients~     operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve~     resection during operation with or without persistent pain and additional 50 patients with~     pain, but no nerve resection during operation. Patients fill in questionnaires and a~     detailed sensory examination, cognitive tests, and a cold water test with autonomic nervous~     system monitoring are performed during the research visit. A selected group of patients~     undergo quantitative sensory testing (QST).~   "
43508|NCT02487511|"~     It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP),~     7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one~     PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7~     or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.~      This study aims to investigate which duration would be better for eradication of HP. The~     study design is a randomized controlled trial. The patients were randomly assigned to 7 days~     or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple~     therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in~     both groups.~   "
43509|NCT02487498|"~     The purpose of this study is to demonstrate that the efficacy of the combination product~     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a~     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.~   "
43510|NCT02487485|"~     The aim of the study is to provide insight into the impact of the immunosuppressant drug~     sirolimus, on the antidepressant effects of the prototypal rapid-acting antidepressant~     medication, ketamine.~   "
43514|NCT02487433|"~     This study will evaluate the drug behavior and safety of a single dose of the 22 milligram~     tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken~     after eating a high fat meal (the effect of food). This will be compared to the drug~     behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550)~     modified-release formulation when taken after a 10 hour fast.~   "
43515|NCT02487420|"~     1. The investigators here want to test the hypothesis that a total period of 18 months of~          gradual open introduction of a certain egg product with regard to full egg tolerance~          induction is not inferior when compared to a total period of 30 months gradual open~          introduction of a certain egg product (see steps for the specific egg products) after~          tolerance for baked egg has been obtained.~        2. The investigators also want to define step-specific 'tolerance-failures' and study the~          relevance of specific IgE to specific egg components to predict failures at each step.~   "
43516|NCT02487407|"~     In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for~     ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During~     each treatment period of the double-blind cross-over part, there will be a baseline visit~     (day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After~     completing the 3rd treatment period, the subjects will continue in the open-label follow-up~     part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An~     end-of-study visit will take place 14-25 days after the last study treatment administration~     for each subject. The study duration will be about 13-14 weeks for the double-blind~     cross-over part, and about 9-10 months for the entire study including the 6 months~     open-label follow-up.~      The number of randomised study subjects is planned to be approximately 54 in cross-over~     comparison. The maximum number of subjects will not exceed 70.~      Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in~     patients with amyotrophic lateral sclerosis (ALS).~   "
43517|NCT02487394|"~     The purpose of the study is to better understand the function of asthma and COPD, and~     response to therapy. There are two Phases to this study broken into two arms. In Phase I,~     our propose is to use discovery proteins and techniques to identify protein expression~     signatures. In Phase II, is to establish and validate the predictive value of protein~     signatures for treatment responses using inhaled corticosteroids.~   "
43518|NCT02487381|"~     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of~     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on~     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal~     processing, and neural oscillations. In addition the effects of the phytocannabinoids on~     lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal~     processing assessed by EEG and fMRI.~   "
43519|NCT02487368|"~     The needle stimulation pad is a self-care device, which has been promoted for pain control~     and well-being. The aim of the study was to test the efficacy of the pad for~     chronic/recurrent low back pain treatment.~      Patients with non-specific chronic or recurrent low back pain were selected from a large~     health insurance company database and advised to use the pad daily for two weeks; outcomes~     were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at~     week 2; secondary outcome measures included the Oswestry disability index (ODI),~     health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ),~     analgesic medication consumption and safety.~   "
43520|NCT02487355|"~     The study will conduct to compare the efficacy of Magnesium sulphate & dexmedetomidine used~     as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as~     post -operative analgesia in pediatric patients.~   "
43521|NCT02487342|"~     Comprising two experiments, the investigators assessed the metabolic, endocrine and~     appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption~     (28-d, part 2) in adolescent males (15-18 y).~   "
43522|NCT02487329|"~     The purpose of this randomized clinical study was to evaluate the efficiency of Er,Cr:YSGG~     laser irradiation combined with a resin based tricalcium silicate material and calcium~     hydroxide (CH) in direct pulp capping for 3 months follow-up period.Sixty permanent vital~     teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15):~     Gr 1: The exposed area was sealed with CH paste, Gr 2: The treated area was sealed with CH~     paste following Er,Cr:YSGG laser irradiation at an energy level of 0,5 W without water and~     45% air, Gr 3: Resin based tricalcium silicate material (TheraCal LC) was applied directly~     to the exposed pulp, Gr 4: TheraCal LC was applied following irradiation with Er,Cr:YSGG~     laser.~   "
43523|NCT02487316|"~     The purpose of this study is to determine the efficacy and safety of crizotinib combined~     with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.~   "
43524|NCT02487303|"~     This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative~     pain after scheduled, elective Cesarean delivery. All patients will receive a standardized~     spinal anesthetic for operative anesthesia and will be randomized into one of three groups:~     (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral~     acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a~     randomized, open label study.~   "
43525|NCT02487290|"~     The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5~     to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac~     following an EVAR procedure.~   "
43526|NCT02487277|"~     We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine~     and nab-paclitaxel in patients with borderline resectable PDAC at the Helen Diller Family~     Comprehensive Cancer Center at UCSF. There are multiple definitions of borderline resectable~     PDAC including the MD Anderson definition and the criteria developed during the Consensus~     Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of~     Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable~     PDAC cases will be identified per the definition developed in the currently running~     inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this~     trial, borderline resectable PDAC is defined as presence of any one or more of the~     following on CT:~        -  An interface between the primary tumor and the superior mesenteric vein or portal vein~          (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall~        -  Short-segment occlusion of the SMV-PV with normal vein above and below the level of~          obstruction that is amenable to resection and venous reconstruction~        -  Short segment interface (of any degree) between tumor and hepatic artery with normal~          artery proximal and distal to the interface that is amenable to resection and~          reconstruction.~        -  An interface between the tumor, and SMA measuring < 180º of the circumference of the~          vessel wall.~      This trial will be conducted in two parts. In Part I, pre-treatment EUS-guided core biopsies~     of the pancreatic tumor, CA 19-9 levels and functional MRIs including DCE-MRI and DWI-MRI~     will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with~     PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI,~     CA 19-9 level and baseline CT chest, abdomen and pelvis. Subsequently, patients will be~     started on treatment with PEGPH20, gemcitabine and nab-paclitaxel given weekly for 3 weeks,~     every 28 days. To evaluate the disease response to treatment, CA 19-9 levels will be checked~     monthly and restaging CT chest, abdomen and pelvis will be obtained every 8 weeks. If there~     is disease progression at any point in the study, patients will be taken off of study and~     alternative treatments will be offered. At the completion of 4 cycles of therapy, restaging~     CT scans will be obtained to determine resectability. If the patients are found to have~     resectable disease, an additional functional MRI will be obtained to evaluate the PDAC~     stroma. If the patients are able to have successful surgeries, tissue analyses will be~     performed on the resected pancreatic tumor. These patients will then proceed to get 2 cycles~     of adjuvant chemotherapy with gemcitabine and nab-paclitaxel. If the patients are deemed to~     be surgical candidates but are found to have unresectable disease in the operating room, an~     intraoperative core biopsy of the pancreatic tumor will be obtained for tissue analyses. At~     the time of initiation of therapy with PEGPH20, patients will be started on prophylactic~     dose of enoxaparin 1 mg/kg subcutaneous daily. This will be continued throughout the study~     participation.~      In Part II, an additional 21 patients will be enrolled, and will begin neoadjuvant therapy~     with PEGPH20, gemcitabine and nab-paclitaxel without the 1 week run-in of PEGPH20-only or~     the pre- and post-run-in EUS-guided biopsies.~   "
43527|NCT02487264|"~     A retrospective analysis of all patient presenting with multiple rib fractures to the~     emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics,~     cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain~     levels and treatment, and sequelae will be recorded and analyzed.~   "
43539|NCT02487108|"~     The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone~     bitartrate/acetaminophen immediate-release tablets at doses of 5.0 mg/325 mg, 7.5 mg/325 mg,~     and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating patients with moderate~     to severe pain following bunionectomy~   "
43869|NCT02482792|"~     The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees~     with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient~     Education in combination with active individual physiotherapy (COPE-PT) on pain, function,~     quality of life and sick-leave~   "
43528|NCT02487251|"~     Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times~     higher risk for obesity compared to middle- to upper-income children. Obesity interventions~     have turned toward the promotion of family mealtimes. Many families report barriers to~     regular mealtimes but barriers in low-income families are intensified. While most prevention~     efforts focus solely on nutrition education and knowledge, this project's approach is built~     on the premises that: 1) enhancing parents' abilities to implement healthy family mealtimes~     is critical to effective obesity prevention; and 2) inconsistent implementation of family~     meals is not due only to a lack of nutrition education or knowledge, but to the adverse~     effects of poverty on parents' capabilities to plan and execute mealtime. The investigators~     propose to test the main, additive and interactive effects of 6 intervention components~     reflecting differing levels of supports to increase the frequency of healthy family~     mealtimes and ultimately reduce childhood obesity prevalence. The investigators will test 6~     intervention components in a Screening Phase (N = 520), resulting in the implementation and~     evaluation of a final intervention model in the Confirming (N = 250) reflecting the most~     effective intervention components tested in the Screening Phase. The investigators~     hypothesize that providing low-income families with effective supports to enhance family~     capability to plan and implement family mealtimes will lead to increased frequency of~     mealtimes and to improvements in children's dietary quality and adiposity indices. Results~     will inform policy (e.g. where limited resources may be allocated for maximum benefit) and~     Extension efforts (e.g. supports most effective in promoting family meals).~   "
43529|NCT02487238|"~     The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbial~     transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory~     bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol~     of twice-weekly retention enemas delivered over six weeks, using fecal transplant material~     from a healthy donor, will improve clinical and biological disease markers in patients with~     pediatric UC or IBD-U.~   "
43530|NCT02487225|"~     This is a single center randomized, double-blind, placebo-controlled study, to be conducted~     at Mayo Clinic, Rochester, MN.~      The objective of our research is to determine whether inhibition of the tumor necrosis~     factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and~     whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP.~     The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either~     the drug or a placebo, which looks like the drug, for a period of 3 days or until the time~     they are discharged, if hospital discharge is within 7 days of admission. The levels of~     markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8~     (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5~     successive days or until the time of discharge, whichever occurs earlier.~      Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours~     of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1)~     amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic~     cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take~     place 24 hours of admission.~      Determination of group size was based on the previous pilot study to decrease any of the~     important adverse outcomes, providing for a dropout rate of 10% during the study. During~     2012, 263 patients with AP were admitted to this institution, which possesses the needed~     infrastructure for successful completion of clinical drug intervention trials.~   "
43531|NCT02487212|"~     The objective of this study is to evaluate the efficacy and safety of using ablative~     fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic~     scar.~   "
43532|NCT02487199|"~     This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or~     without dasabuvir in adult genotype 1a or genotype 4 hepatitis C infected participants with~     severe kidney impairment or end-stage kidney disease.~   "
43533|NCT02487186|"~     The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement~     associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic~     generalized periodontitis treatment.~   "
43534|NCT02487173|"~     The primary purpose of this study is to validate the sensitivity and specificity of the~     Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold~     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).~      The secondary aims are to:~        -  validate the sensitivity and specificity of the Respirio Flu Test in detecting~          Influenza B , when used by subjects, as compared to the gold standard for detection,~          Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).~        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza~          A+B Test in detecting Influenza A;~        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza~          A+B Test in detecting Influenza B;~        -  evaluate the correct interpretation of the Respirio Flu Test results by subjects with~          Influenza-like illness symptoms;~        -  evaluate the subjects' satisfaction with the convenience, comfort and ease of use of~          the Respirio Flu Test;~        -  evaluate the subjects' comprehension of the Respirio Flu Test labelling; and~        -  establish the minimum sample weight required to achieve a result with the Respirio Flu~          Test.~   "
43535|NCT02487160|"~     The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular~     lens.~   "
43536|NCT02487147|"~     This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR)~     system versus a N95 mask in preventing nasal detection of influenza following an exposure.~     The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95~     respirator at interrupting the exposure of the study participants to aerosolized influenza~     virus particles.~   "
43537|NCT02487134|"~     Patients with at least two risk factors for incisional hernia undergoing abdominal surgery~     are eligible for inclusion. After accepting informed consent, patients are randomized into~     either closing the abdominal wall in a regular way with fascial sutures, or closing with~     fascial sutures together with placing a TIGR mesh as described. All patients are then~     monitored for signs of infection, wound rupture, incisional hernias, subcutaneous seroma as~     well as postoperative symptoms. All patients will be followed for at least 5 years. One year~     postoperatively, a computer scan is performed to detect asymptomatic incisional hernias.~   "
43540|NCT02487095|"~     Background:~      Chemotherapy damages cancer cell DNA so the cells die and the tumor shrinks. But it may stop~     working in some people over time. This is partly due to efficient DNA damage repair~     mechanisms used by tumor cells. VX-970 may stop cancer cells from preventing the repair of~     DNA damaged by chemotherapy. The purpose of this study is to see if using the chemotherapy~     drug topotecan along with the drug VX-970 will improve the response to chemotherapy.~      Objective:~      To study the safety and efficacy of VX-970 and topotecan in treating small cell lung cancer.~      Eligibility:~      Adults at least 18 years old with small cell lung cancer .~      Design:~      Participants will be screened with medical history, physical exam, blood and heart tests,~     and scans. Most of these tests are part of their routine care. Most of these tests will be~     repeated throughout the study.~      The study is set in 21-day cycles. Participants will get topotecan IV on days 1 through 5.~     They will get VX-970 IV on day 5 alone or on day 5 and day 2.~      Participants doctors will monitor them weekly for the first cycle, every 3 weeks after that.~      For Part 1 of this Study the doses of topotecan and VX-970 will be increased (according to~     the Protocol) to determine the maximum safe dose of the combination. The maximum safe dose~     of the combination is the dose at which no more than 1 in 6 people have an intolerable side~     effect.~      More participants will join in Phase 2. They will take the drugs at the maximum safe dose,~     on the same schedule as the drugs were taken in Phase 1.~      Participants will give samples of blood, hair, and tumor tissue (optional) at different~     times. They will discuss side effects at every visit.~      A month after stopping taking the drugs, participants will have a physical exam and blood~     drawn. They will have follow-up phone calls every 3 months.~   "
43541|NCT02487082|"~     The purpose of this study is to test the combined effect of melatonin and donepezil on~     improving sleep and behavior in children with Autism Spectrum Disorders. Melatonin is a~     natural neurohormone that helps regulate sleep and wake cycles. Donepezil is used to improve~     mental function for people with Alzheimer's disease. Children with Autism Spectrum Disorders~     are more likely to have problems sleeping than other children. This difficulty has been~     linked to daytime behavioral problems and family stress.~   "
43542|NCT02487069|"~     The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell~     transplantation (allo-HSCT) from sibling matched donor (SMD),matched unrelated donor (MURD)~     and haploidentical related donors(HRD) in the treatment of hematologic malignancy.~   "
43543|NCT02487056|"~     The purpose of this study is to compose a national database of the etiologies, clinical and~     demographic characteristics, using diagnostic tests, precipitating and risk factors,~     management of from intensive care unit or coronary care unit to hospital discharge, length~     of stay in the intensive care unit and hospital, in-hospital mortality and discharge~     medications of hospitalized acute heart failure patients in Turkish population.~   "
43544|NCT02487043|"~     Despite improvements in oral health among children, children living in areas characterized~     by low socio-economic status still have a significant disease burden with regard to dental~     caries. Special efforts to prevent disease development in this group of children have been~     unsuccessful. Small children with extensive treatment needs often have limited abilities to~     cooperate and to provide quality dental care in this patient group, general aneaethesia (GA)~     may often be the treatment modality of choice. Preschool children treated under general~     anesthesia have significantly higher caries prevalence (deft and defs), apical parodontitis~     and infection due to pulpal necrosis. They also have significantly more emergency visits and~     previous use of treatment under sedation.~      This study aim to test the hypothesis, that a telephone based case management intervention~     for children with severe early childhood caries can prevent further caries development in~     preschool children who are treated under general anesthesia for severe early childhood~     caries.~   "
43545|NCT02487030|"~     This study will evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir~     (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults~     with chronic genotype 4 hepatitis C virus (HCV) infection.~   "
43546|NCT02487017|"~     Evaluation of DC-CIK cells combined TACE treatment for HCC~   "
43547|NCT02487004|"~     The purpose of this study is to determine whether the change of serum and dialysate sodium~     level during hemodialysis can influence on blood pressure and intradialytic weight gain in~     chronic hemodialysis patients.~   "
43548|NCT02486991|"~     Thirty patients will be treated: 15 with a coronally positioned tunnel technique plus~     intramucosal verticals with AlloDerm® (test treatment) and 15 with a coronally positioned~     tunnel technique alone with AlloDerm® (control treatment). The surgical procedure for the~     control sites will consist of a coronally positioned tunnel preparation that is a~     modification of a previous tunnel technique described by Allen AL (Allen AL, 1994a/1994b).~     This tunnel technique was modified to include coronal positioning of the soft tissue over an~     allograft (E.P Allen). The surgical procedure for the test sites will consist of a coronally~     positioned tunnel preparation (E.P. Allen) plus the use of mesial and/or distal intramucosal~     verticals, a modification of the vestibular incision subperiosteal tunnel access (VISTA)~     approach (Zadeh H, 2011). Each patient will provide at least one Miller Class I or II facial~     recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive~     either the test or control treatment. Three exams for measurements will be performed per~     patient on total: preoperative, at week eight and 16 (4 months) postoperatively. The primary~     aim is to compare the percent root coverage obtained with acellular dermal matrix using the~     coronally positioned tunnel technique alone or with intramucosal verticals.~   "
43549|NCT02486978|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak~     concentration usually after 30 minutes. When the body senses the increase in blood glucose,~     a hormonal process involving insulin takes place to ensure that the glucose is taken up from~     the blood for storage and where it is needed for energy in the body. This process then~     brings about a decrease in the concentration of glucose until it reaches approximately the~     starting concentration. The original concentration of glucose is attained approximately 2~     hours after eating or drinking a carbohydrate food or sugary drink respectively in healthy~     people.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.~      Research has shown that diets that give rise to a high glucose response are associated with~     a number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome~     mostly comprises of insulin resistance and glucose intolerance which gives an increased risk~     of type 2 diabetes. It also gives rise to other conditions like high blood pressure~     (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts~     of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood~     (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular~     disease also rises. Research has also shown that foods/drinks which raise blood glucose~     levels gradually (low GI) rather than rapidly (high GI) have health benefits which include~     reducing the risk of metabolic syndrome. Laboratory studies have shown that polyphenols~     found in fruits, vegetables and plant based foods have a positive effect on carbohydrate~     metabolism and can lower the blood glucose levels.~      This research will determine whether the presence of polyphenols in the diet has any~     lowering effect on the blood glucose levels and hence the glycaemic index of foods. This~     will be determined by asking volunteers to consume commercially available food supplements~     together with white bread and then determining the glycaemic response. The blood glucose~     response of bread will be determined initially as a control reference. All will be consumed~     in random order.~      Analysis will be done by measuring blood glucose response after consumption of the control~     reference meal and the test meal containing polyphenols and then determining the incremental~     area under the glucose curve.~      POMEGRANATE AND OLIVE STUDIES WILL BE TREATED SEPARATELY FOR PURPOSES OF PUBLISHING RESULTS.~     EACH STUDY WILL AIM TO HAVE AT LEAST 16 PARTICIPANTS.~   "
43550|NCT02486965|"~     Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of~     widespread pain in all four quadrants of the body. Currently, there is no causal treatment~     of fibromyalgia syndrome.~      The aim of this study is the evaluation of a specific training program on controls of pain~     in fibromyalgia patients by balancing the stress axis.~      The primary endpoint is the improvement in the Visual Analogue Scale VAS difference)~     measured during the test of the thermode (difference between the average VAS measured~     between the 10th and 40th second of P1 and the average VAS measured between the 10th and~     40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of~     study visit), which will be compared in the two groups..Salivary cortisol is also tested.~   "
43551|NCT02486952|"~     Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in~     combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL).~     Participants, who were not treated previously for DLBCL, will receive MabThera in~     combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or~     CHOP-like chemotherapy according to registered indication. Patients will be followed up for~     safety and efficacy evaluation in accordance with routine practice. The study will be~     non-interventional and by its design purely observational. All treatments prescribed during~     the observation period will be at the treating physician's discretion and will be prescribed~     according to package labeling, within approved indication and local approval status of~     respective drugs.~   "
43552|NCT02486939|"~     An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and~     durability of response of subjects who completed 48 weeks of evaluations in the confirmatory~     safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients~     with rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.~   "
43553|NCT02486926|"~     Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating~     airway properties, rapid induction and emergence. However, it is associated with emergence~     agitation (EA) in children. EA may cause injury to the child or to the surgical site and is~     a cause of stress to both caregivers and families. Various pharmacologic agents have been~     suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This~     study was designed to compare the effects of remifentanil and remifentanil combining~     alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.~   "
43554|NCT02486913|"~     The investigators will develop a risk report within the primary care electronic health~     record (EMIS) for patients attending for their National Health Service Health Check. The~     value of the report for reducing cardiovascular risk will be assessed qualitatively and also~     quantitatively in a non-randomised comparative trial.~   "
43555|NCT02486900|"~     The study aims to examine whether the neurofeedback method (based on functional magnetic~     resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges~     to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on~     abstinence and drinking behaviour will be evaluated based on the comparison between a group~     of patients receiving multiple sessions of neurofeedback training and a group of patients~     receiving treatment as usual over the same period of time.~   "
43556|NCT02486887|"~     The main objective of the study is to evaluate the effect of telemonitoring on mortality and~     rehospitalization due to heart failure on patients with chronic heart failure which have~     follow an educational program compared to a conventional follow-up during 1 year.~      The secondary objectives of the study are :~        -  Evaluate the cost of health~        -  Qualitatively evaluate telemonitoring on uses~        -  Evaluate quality of life~   "
43557|NCT02486874|"~     PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine,~     Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is~     a permanent dermal substitute aiming to reduce skin contracture. The objective of this study~     is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.~   "
43558|NCT02486861|"~     The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive~     patients that perform OCT on culprit and not culprit plaque in any subset in patients with~     ACS. Clinical and OCT data will be included in the register according to the dataset.The~     primary endpoint will be the correlation of OCT characteristics with incidence of major~     adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes,~     non- fatal MI, clinically driven target vessel revascularization (TVR), or~     re-hospitalization due to unstable or progressive angina according to Braunwald Unstable~     Angina Classification) and clinical baseline characteristics.~      In particular subanalysis will be performed in the following subgroups: culprit plaque, not~     culprit plaque in culprit vessel, not culprit plaque in different vessel.~      Secondary end-point will be to evaluate how OCT analysis changed interventional cardiology~     approach in culprit plaque definition and coronary stenting respect the coronary angiography~     alone.~   "
43559|NCT02486848|"~     5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of~     female pattern hair loss. While topical minoxidil exhibits a good safety profile, the~     efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.~      The primary purpose of this study is to assess if a higher dosage of topical minoxidil~     dosage (15%) will increase the number of responders among female subjects that have been~     identified through IVD testing as non-responders to 5% topical minoxidil.~   "
43560|NCT02486835|"~     Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm~     cough spells without sedating the reflex. The intent of this study is to use a protective~     syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and~     safety versus placebo in children with moderate to severe night and daily cough. Cough is~     assessed with a validated parent questionnaire. The degree of disturbance of cough is~     followed immediately after one night administration of the study products and daily for 4~     nights, 3 days.~   "
43561|NCT02486822|"~     This study aims to compare the novel labour scale with the traditional WHO partograph in the~     management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes~   "
43562|NCT02486809|"~     This study will assess the bioequivalence in healthy participants between a~     high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as~     a single injection by a needle and syringe, and a low-concentration formulation of~     lebrikizumab administered SC as a single injection via PFS-NSD.~   "
43566|NCT02486757|"~     Irregular menstrual cycles are common in girls for several years after their first menstrual~     period. The cause of abnormal menstrual cycles during this time is not well-understood. The~     purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine~     sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release~     of an egg from the ovary), and 2) determine whether cycles can be corrected by treating~     girls with a short course of low-dose estrogen and progesterone.~   "
43567|NCT02486744|"~     This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis~     [NDHD] patients receiving dialysis for ≤ 2 years. The project will aimed at providing~     proof-of-concept data that 80 U two times [2x] week Acthar for 6 months is a safe and~     effective therapy for NDHD. Effectiveness of lower dose 40 U 2X week will also be~     determined. Therefore the study will be a repeated measures design (Time x condition)~     comparison of improvement in renal function, nutritional status, quality of life and~     physical performance resulting from Acthar therapy.~   "
43568|NCT02486731|"~     Noonan and LEOPARD syndromes share, with variable severity, different clinical traits,~     notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers.~      The main genetic cause of these syndromes is missense mutation of the gene encoding the~     ubiquitous tyrosine phosphatase Shp2, found in more than half the patients with NS and in~     80% of LS cases. Shp2 plays pivotal roles in development, growth, and metabolism by~     regulating key signalling pathways (Ras/Mitogen activated protein kinase (MAPK),~     Phosphoinositide-3 Kinases (PI3K)/Akt) in response to growth factors/hormones. Deregulation~     of these signalling pathways has been causally linked to NS and LS pathophysiology.~      This project aims at better understanding hormonal sensitivity abnormalities in patients~     with Noonan syndrome (NS) or LEOPARD syndrome (LS) caused by mutations of the tyrosine~     phosphatase Shp2.~      To reach this goal, the investigators will take advantage of different tissues (fibroblasts~     ± adipocytes) from patients with NS / LS compared to healthy controls.~      All patients will have a skin biopsy and only patients about to undergo surgery will have a~     adipose tissue biopsy.~   "
43569|NCT02486718|"~     The primary efficacy objective of the study is to evaluate the efficacy of 16 cycles of~     Atezolizumab (MPDL3280A) treatment compared with best supportive care as measured by~     disease-free survival (DFS) as assessed by the investigator~   "
43570|NCT02486705|"~     The proposed pilot study is designed to test the feasibility, acceptability, and potential~     effectiveness of a mobile phone application (app) developed by the VA National Center for~     PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder~     (PTSD). The primary objective of the proposed study is to assess whether family members of~     veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use.~     Secondary objectives are to determine if use of the app increases family members'~     self-efficacy and their ability to manage their own life stress, which may in part be the~     result of living with someone who has PTSD.~   "
43571|NCT02486692|"~     The purpose of this study is to evaluate the AboutFace peer education website for the~     purpose of reducing stigma and improving attitudes toward seeking mental health services~     among Veterans.~   "
43572|NCT02486679|"~     A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley~     catheter for cervical ripening.~   "
43573|NCT02486666|"~     Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the~     treatment of neonatal thrombosis that is monitored with anti-factor Xa (anti-Xa) levels.~     However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult~     studies. The burden of pain to neonates due to venipunctures and of resources to the health~     care system also warrants a evidence-based review to assess the utility of monitoring LMWH~     therapy with anti-Xa levels. Here the investigators describe the FiXET trial.~      Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized~     controlled trial to compare the approach of treating thrombosis in neonates with enoxaparin~     using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined~     anti-Xa range (0.5-1.0 u/mL). The investigators plan to recruit 20 neonates over a 6 month~     period, who will be randomized prior to their first anti-Xa level being resulted. Key~     feasibility outcomes include screening/:recruitment ratio, monthly recruitment rate, and~     completeness of data collection. The investigators will also measure the safety outcome of~     bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome.~      Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa~     monitoring has the potential to reduce pain from multiple venipunctures in neonates as well~     as resources used in their already complex care. The results of the FiXET trial will set the~     framework for a larger multicenter randomized controlled trial to compare the efficacy of~     administering enoxaparin to neonates without monitoring to the current conventional approach~     of routine monitoring with anti-Xa levels.~   "
43574|NCT02486653|"~     The purpose of this study is to determine if tamsulosin (FLOMAX) is effective in~     preventing post-operative urinary retention following abdominal surgery. Post-operative~     urinary retention is a common post-operative complication, occurring in up to 30% of~     patients undergoing abdominal surgery. It can be described as the inability to initiate~     urination or properly empty one's bladder following surgery. It is usually self-limited, but~     it requires the use of catheterization to empty the bladder in order to prevent further~     injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin~     is a medication that is commonly used in men with urinary symptoms related to an enlarged~     prostate. There is some evidence to suggest that it may also potentially be beneficial for~     preventing post-operative urinary retention. Therefore, in this research study, subjects~     scheduled for abdominal surgery will be randomly assigned to take either tamsulosin~     once-daily or placebo once-daily for one week leading up to surgery, and up to several days~     after surgery. Urinary function will be assessed and compared between these two treatments.~     The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention~     compared to placebo.~   "
43575|NCT02486640|"~     This study aims to evaluate potential predictors of adherence by investigating a~     representative cohort of MS patients in Germany treated with Betaferon~   "
43576|NCT02486627|"~     This is a randomized, multicenter, multinational, double-blind study comparing the efficacy~     and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in~     the treatment of cUTI, including AP, in adults.~   "
43577|NCT02486614|"~     The aim of this study is to evaluate the effect of regional citrate anti-coagulation on~     different pathways of the coagulation system in critically ill patients with acute kidney~     injury. This will form the basis for future studies where the investigators plan to focus on~     patients with premature circuit clotting despite optimal post-filtrate ionised calcium~     parameters.~   "
43578|NCT02486601|"~     This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist~     in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown~     University Phase I study.~      In neoadjuvant setting : 3 months of treatment~      Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable~     toxicity, or patient decision.~      Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the~     result of the neo-adjuvant treatment and the ability of patients to receive adjuvant~     chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative~     condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less~     than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and~     post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks~     post-operatively.~   "
43579|NCT02486588|"~     In collaboration with Vitality/Discovery in South Africa, an RCT amongst adult enrolled in~     the lowest tier of Vitality's HealthyFood benefit will be conducted. We will compare the~     effect of various messaging, and financial incentive strategies on healthy food purchasing~     behaviors in this population.~   "
43580|NCT02486575|"~     More than 50 residents in surgical specialities (OB&G, General surgery and Urology) from a~     single university in Italy will be randomized into two groups, after a stratification based~     on residency year and laparoscopic/simulator experience. The first one will train to FLS~     (fundamentals of laparoscopic surgery) following pre-recorded instruction from course~     materials; the second one will be mentored by a proctor in single training section. The aim~     is to evaluate the best way to train residents applying for the very first time in an~     extensive way the fundamentals of laparoscopic surgery program in an Italian Institution.~   "
43581|NCT02486562|"~     iConquerMS™ is a research initiative developed by and for people with multiple sclerosis~     (MS) to contribute their health data and ideas to advance and accelerate research into MS.~   "
43582|NCT02486549|"~     The purpose of this study is to compare the supraclavicular block to interscalene block in~     patients undergoing arthroscopic shoulder surgery.~   "
43583|NCT02486536|"~     The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation~     in patients referred for CE examination.~   "
43584|NCT02486523|"~     The objective of the research is to assess the effectiveness of adding a Household WASH~     component to the standard outpatient treatment of severe acute malnutrition.~      Study design: cluster-randomized controlled trial comparing two interventions:~        1. Control group: outpatient management of children diagnosed for severe acute~          malnutrition only~        2. Intervention group: outpatient management of children diagnosed for severe acute~          malnutrition + household WASH package~      2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic~     Program) centers for SAM will be included into the study and followed for 8 months (2 months~     of treatment, and 6 months after successful discharge).~   "
43585|NCT02486510|"~     Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy~     and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and~     controlled clinical trial.~   "
43586|NCT02486497|"~     Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a~     predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it~     as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to~     investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen~     between gemcitabine and 5-fluorouracil (5-FU).~   "
43587|NCT02486484|"~     Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration~     (AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions.~     Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the~     expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to~     the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept.~     Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes~     over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous~     saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not~     report any untoward toxic effects but attested to the clinical efficacy of the medication.~     Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of~     intravitreal ziv-aflibercept.~      Methods: Prospectively, consecutive patients with retinal disease that require aflibercept~     (AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept~     intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25mg). Monitoring of~     best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal~     structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2~     years after injections.~      Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change~     in lens status, together with best corrected visual acuity and central foveal thickness at 1~     month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of~     ziv-aflibercept improves visual acuity without ocular toxicity and offers a cheaper~     alternative to the same molecule aflibercept (or lucentis), especially in the third world~     similar to bevacizumab.~   "
43588|NCT02486471|"~     Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To~     avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical~     Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The~     Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the~     patient and influence of Independent factors such as Age and Body mass index.~   "
43604|NCT02486263|"~     The overall purpose of the investigator's study is to evaluate the causes of and treatment~     for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New~     treatments can be possible only if the cause is known. Many infants have GERD and feeding~     difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the~     stomach. Some of these infants have difficulty in protecting their airway during feeding or~     during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most~     GERD treatments are done based on experience, but there is no scientific proof that these~     methods work for infants. GERD and feeding difficulties can lead to longer hospitalization~     and more stress for the family.~      In this clinical trial, the investigators are developing new methods to help with diagnosis~     as well as defining better treatment strategies in relieving GERD and GERD complications.~   "
43589|NCT02486458|"~     The anticaries effect of professional fluoride application has been associated with the~     formation of calcium fluoride-like products (CaF2) on dental surface, which may function~     as a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and~     varnish are the most important, and have different soluble fluoride concentrations, pHs and~     vehicles. Although the concentration of fluoride formed on enamel after the use of both is~     similar, the retention of these reaction products is unknown. Also, it is unknown the~     capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the~     effect of the varnish application time on these parameters is unknown. Therefore, the aim of~     this study is to compare the capacity of fluoride gel and varnish to form fluoride~     reservoirs on enamel and increase dental biofilm fluid fluoride concentration with time.~     Rapid biofilm-forming individuals will be selected to participate and divided into 4~     experimental groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish~     will be applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be~     applied on teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth.~     Microbiopsies of enamel will be obtained by a microbiospy technique to assess fluoride~     concentration before, 7 and 28 days after the treatments. Dental biofilm will be collected~     before and 3, 7, 14 and 28 days after treatments. Fluoride concentration on enamel and in~     the biofilm fluid will be determined by an ion-specific electrode. Data will be analyzed~     statistically comparing the groups and collection times.~   "
43590|NCT02486445|"~     This prospective outcome study is designed to assess the safety of rivaroxaban in the~     pre-diagnosis phase of DVT.~   "
43591|NCT02486432|"~     A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral~     Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach~   "
43592|NCT02486419|"~     The primary objective in this study is to examine the seasonal variation in genetic markers~     in the deep neck adipose tissue in humans.~      Human adipose tissue biopsies are taken from patients admitted for elective surgery in the~     neck. During the surgical procedure a subcutaneous adipose tissue biopsy is taken for~     reference.~   "
43593|NCT02486406|"~     The purpose of this three part study is to evaluate the pharmacokinetics (Part 1),~     safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir~     (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV)~     in pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.~   "
43594|NCT02486393|"~     The investigators conducted a prospective study of 132 patients undergoing benign parotid~     surgery at our department. Their primary objective was to analyze the incidence of and~     contributing factors associated with temporary and permanent postoperative facial palsy with~     strictly standardized methods in facial nerve function evaluation. Also other complications~     occurring within 12 months of operation were recorded.~   "
43595|NCT02486380|"~     This investigation is to evaluate the performance, comfort and ease of use of the Simplus~     and Eson masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight~     study.~   "
43596|NCT02486367|"~     The central hypothesis of this study is that TAVR leads to platelet deposition and~     inflammatory cell activation that can be attenuated by the potent anti-platelet and/or~     pleiotropic effects of ticagrelor.~      This single center, prospective randomized trial addresses the following specific aims:~        1. To determine whether high-potency ADP receptor blockade reduces measures of platelet~          activation in patients after TAVR.~        2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic~          inflammatory response observed after TAVR.~   "
43597|NCT02486354|"~     This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the~     efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after~     failure of at least one platinum-based chemotherapy regimen.~   "
43598|NCT02486341|"~     Basal insulin is widely used in older patients with diabetes. Human insulin Neutral~     Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older)~     frail and dependent patients due to its shorter action. However, no study has analysed the~     glycaemic profile in elderly subjects according to the basal insulin used, particularly in~     frail or disabled patients.~      The aim of this study is to measure intra-day glycaemic variability according basal insulin~     (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with~     diabetes using continuous glucose monitoring system.~   "
43599|NCT02486328|"~     There are different sedation regimes for lower GIS endoscopy which can be administered by~     anesthesiologists and non-anesthesiologists. This study aims to compare the effects of~     propofol/remifentanil combination and midazolam/meperidine combination on early cognitive~     function following lower GIS endoscopies.~   "
43600|NCT02486315|"~     The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System;~     Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed~     to cover the lesion at the level of the carina. Although deemed ideal for lesions involving~     only the proximal MV (1,0,0 according to Medina classification ref), this device may be used~     also in more complex bifurcation lesions when additional DES are required in the distal MV~     and/or in the SB. In the present registry the investigators report the performance and the~     efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of~     bifurcation lesions in a real-world population.~   "
43601|NCT02486302|"~     The purpose of this non-interventional study is to evaluate the efficacy of etanercept~     during routine clinical use over a maximum of 12 months in patients with rheumatoid~     arthritis, psoriatic arthritis, axial spondyloarthritis, or plaque psoriasis. In so doing,~     particular attention will be paid to the proportion of those patients who only attain the~     desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the~     study is the proportion of patients who attain the desired treatment goal after 12 and 24~     weeks,~   "
43602|NCT02486289|"~     A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment~     of mercury intoxication.~   "
43603|NCT02486276|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor~     (cilostazol). If the headache responds to sumatriptan, the model can be used to test new~     drug candidates.~   "
43605|NCT02486250|"~     This is a three year study conducted in cooperation with the Brain Health Registry (BHR), an~     internet-based registry which will enroll 50,000 individuals in Northern California in order~     to facilitate clinical trials for the prevention of Alzheimer's disease (AD). The~     investigators goal is to validate the Brain Health Registry's online cognitive measures~     developed by Lumosity. Investigators will meet this goal by collecting data from the newly~     developed the BHR online cognitive screening battery along with standardized measures of~     memory, attention, executive functioning and speed of information processing currently used~     in clinical trials for Alzheimer's disease.~   "
43606|NCT02486237|"~     Retrospective, observational study to determine the prevalence of complications in Central~     American diabetic patients.~   "
43607|NCT02486224|"~     Kona Deep is bottled water extracted from a depth of 3000 feet off the cost of Kona, Hawaii.~     Kona Deep claims that this unique source provides water that is naturally free of~     pathogens, chemicals and pollutants and rich in nutrients and minerals that are readily~     absorbed by the body. The investigators wish to examine Kona Deep's claim that this water~     is beneficial to the human body by testing the impact of drinking Kona Deep on exercise~     performance and recovery. Subjects will be exercised to a safe level of dehydration and then~     will be rehydrated with Kona Deep water, or commercially available bottled spring water or~     Gatorade as controls. Subjects will perform a simple exercise to evaluate peak power~     performance. This measurement will be compared between rehydration methods for significant~     differences.~   "
43608|NCT02486211|"~     This study evaluates if amantadine will increase the rate of awakening in patients~     resuscitated from cardiac arrest but comatose (not following commands) after their~     resuscitation. Half of the participants will receive amantadine and the other will receive~     placebo.~   "
43609|NCT02486198|"~     The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium~     injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.~   "
43610|NCT02486185|"~     Background to the research: Sarcopenia is a geriatric syndrome defined by progressive~     generalised loss of skeletal muscle, mass, force and function.~      Problem statement and objectives: To validate a simple, reproducible, screening tool, which~     is easy to use in the general practitioner's surgery is one of the challenges of the future.~      The primary objective is to assess the sensitivity and specificity of the study screening~     test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated~     with poor physical performance and is also predictive of the clinical diagnosis of the~     disease. The secondary objectives are to assess the prevalence of sarcopenia in the study~     population, to carry out a subgroup analysis of statistical performance for the five~     questions tested by the SARC-F, to identify the main risk factors associated with the~     disease and to propose an algorithm, positioning the SARC-F at the heart of a systematic~     screening process for the disease.~      Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and~     analytical epidemiological component to analyse the secondary endpoints. It will be carried~     out in usual care over a period of 6 months in a homogeneous population of 65-year-old and~     older patients from the community consulting in primary care. The subjects will undergo the~     screening test (SARC-F questionnaire) and then the reference clinical assessment (gold~     standard) in succession.~      Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a~     simple tool, appropriate for early screening of sarcopenia in primary care.~   "
43611|NCT02486172|"~     This is a pre-and-post study with a study duration of one year involving 7 diabetes centres~     in Hong Kong. A group of motivated patients with type 2 diabetes will be trained as peer~     supporters in two training workshops. Patients who may benefit from peer support program~     will be recruited as peers. In the one year study period, peer supporters are required to~     have 2 face-to-face interviews and 12 phone calls. Clinical parameters and psycho-behavioral~     parameters of both peer supporters and peers will be evaluated at the baseline and at the~     end of the study.~   "
43612|NCT02486159|"~     Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in~     allergic rhinitis patients before and after a series of acupoint herbal plaster and~     Acupuncture treatment.~      In the first year, Twenty-three participants with persistent allergic rhinitis each received~     four acupoint herbal plaster treatments, applied using the moxibustion technique, and~     clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ).~     Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were~     classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for~     genes that were differentially expressed between (1) Ph-positive and -negative patients~     treated with herbal paste; and (2) before and after herbal paste treatment in the~     Ph-positive patient group.~      In the second year, Twenty-seven participants with persistent allergic rhinitis each~     received four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over~     4 weeks in the same time.~   "
43613|NCT02486146|"~     The purpose of this study is to establish the working protocols for a general biorepository~     with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal~     tract from a diverse range of clinical patients at the UC Davis Medical Center. The~     establishment of a GI-specific biorepository will support future translational endeavors~     within the UC Davis campus by providing laboratories with readily available GI tissue and~     bodily fluid samples to test newly developed hypotheses with relative ease.~   "
43614|NCT02486133|"~     A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV)~     Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard~     of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase~     Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with~     RTV-boosted DRV in combination with 2 NRTIs.~   "
43638|NCT02485808|"~     The purpose of this study is to advance our understanding of people who experience urinary~     and bladder problems. We are interested in learning about people's experiences with urinary~     symptoms and how these symptoms will be managed. We want to understand the important~     differences among people and what factors affect urinary and bladder problems. After all of~     the information is collected, we will have a better understanding of how to improve the care~     and treatment for people who have urinary and bladder problems.~   "
48012|NCT02428595|"~     Multi-center, prospective, within-subject control, open label clinical trial to evaluate the~     durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of~     use.~   "
43615|NCT02486120|"~     Background:~      - Suicide is one of the main causes of death for adolescents in the U.S. The most effective~     way to decrease suicide is by training doctors to recognize the risk factors in their~     clients. One risk factor for suicide is chronic illness. So pediatric genetic counselors~     come across high-risk clients. But the suicide risk assessment (SRA) practices of these~     counselors are not well known. Researchers want to study learn more about this.~      Objectives:~      - To describe the practices, attitudes, and beliefs of genetic counselors about SRA of~     adolescents.~      Eligibility:~      - Genetic counselors who see adolescents ages 10 21~      Design:~        -  A study will be open to a listserv for genetic counselors.~        -  Participants will take a survey on their own.~        -  The survey will be online on a secure website.~        -  Participants will give data about themselves. This can include age, gender, job, etc.~        -  The survey will be about 60 questions.~        -  The survey will take around 20 25 minutes.~        -  The questions are about participants experiences, practices, attitudes, and beliefs~          about SRA.~   "
43616|NCT02486107|"~     In case of cervical foraminal stenosis without central stenosis, there are several options;~     anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF)~     and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern~     technique and there was no RCT with MTPF, although P-PECD showed not inferior result to~     ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no~     comparative study.~      The primary object of the study is to compare radiological outcome (segment angle) after~     MTPF or P-PECD.~   "
43617|NCT02486094|"~     This study tests biopsy and tissue from patients who have been treated for primary rectal~     cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at~     post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and~     proliferative index count pre and post chemoradiotherapy.~   "
43618|NCT02486081|"~     Children with disabilities are frequently ignored by the general population, hence the~     development of movement evaluation and training devices for use in special education~     settings are relatively overlooked. Usually the performance of these children is not stable~     and contains variations. Hence in order to get a complete picture of their sport~     performance, simply measuring movement time and distance is definitely not representative.~     With the rising attention from government regarding fitness and social participation of the~     disabled in recent years, developing a special-designed individual evaluation & training~     plan is of great importance. To achieve this goal, a device which is able to record the~     complete process of movement, and contains algorithm that can pick up the movement~     characteristics of children with disabilities is needed. The purpose of this study is to~     design and develop a smart soccer ball system for use in children with intellectual~     disabilities(ID), and to compare the performance between children with ID and the typically~     developed.~   "
43619|NCT02486068|"~     The primary objectives of this trial are:~      In patients at high-risk for restenosis,~        -  To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the~          everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF)~          at 1 year~        -  To assess superiority of the BRS to the EES in TLF between 1 and 5 years~   "
43620|NCT02486055|"~     This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in~     healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects~     receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600~     mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The~     cohorts may be enrolled sequentially.~   "
43621|NCT02486042|"~     Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely.~     These infants do not have enough essential fatty acids to structurally support the retina,~     the nerve tissue in the eye which allows us to see. A recent study showed that giving~     omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need~     invasive treatments for eye disease. This research trial will give young infants born~     prematurely n-3 fish oil treatment and look at how this changes factors in the blood that~     promote disease. Detailed blood studies comparing infants with and without ROP will be~     performed and the infants will be followed over time to assess their eye development.~   "
43622|NCT02486016|"~     This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare~     fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)~     fentanyl skin patches in healthy adults.~   "
43623|NCT02486003|"~     This study will assess the effectiveness of a portable goggle system in the diagnosis of~     mild traumatic brain injury (mTBI) in athletes.~   "
43624|NCT02485990|"~     This study will be looking at what dose of tremelimumab and olaparib is safe and effective~     in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal~     Carcinoma).~   "
43625|NCT02485977|"~     The overall goal of this study is to evaluate agreement between cardiac MR parameters and~     well-established clinical and catheterization parameters of poor prognosis in patients with~     pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate~     myocardial disease in patients with pulmonary hypertension would be beneficial to society~     due to the potential to replace serial invasive cardiac catheterization procedures with a~     noninvasive imaging test.~   "
43626|NCT02485964|"~     To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT)~     assay, which measures antigen-specific interferon-secretion.~   "
43639|NCT02485795|"~     The purpose of this study is to evaluate the impact of genetic testing on healthcare~     decisions and patient outcomes in interventional pain management clinical care. Results of~     genetic testing will also be compared with the clinical outcome measures collected to~     discover novel genetic factors that may influence patient care.~   "
43640|NCT02485782|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke~     Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a~     impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis.~     GmbH Ilmenau) beginning 15 min prior to midweek dialysis session and continuous measurement~     thereafter, with a 15-min period after the termination of hemodialysis. Fluid overload were~     measured by BCM Monitor Fresenius before hemodialysis.~   "
48013|NCT02428582|"~     To compare the outcome of revascularisation the gastrointestinal arteries using covered~     stents compared to bare-metal stents in patients with CGI.~   "
43627|NCT02485951|"~     Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to~     create a uniform recipient bed, thereby reducing complications, such as interface~     irregularity and opacification encountered with conventional lamellar keratoplasty. The~     big-bubble technique provides a planned, safe, quick and consistent baring of Descemet~     membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a~     long learning curve with a low success rate of big-bubble formation and a high rate of DM~     perforation when performed by surgeons in training. Different modifications to the original~     technique using intraoperative instruments such as corneal pachymetry, anterior segment~     optical coherence tomography (OCT), and femtosecond laser, have been used to increase the~     chances of achieving a successful DM detachment from the deep stroma by air injection. Even~     with these innovations, the rate of successful big-bubble formation did not reach 100%.~     Recently, the investigators described a modification to the original big-bubble DALK in~     which a 27-gauge needle was inserted into the stroma peripherally from the trephination site~     towards the limbus. The investigators found that air injection peripheral to the~     trephination can effectively and reproducibly separate the corneal stroma from the Descemet~     membrane (DM). This study was aimed to compare the success rate and complications of~     big-bubble DALK using central versus peripheral air injection performed by senior cornea~     fellows under the supervision of an experienced faculty member in an academic hospital.~   "
43628|NCT02485938|"~     Male subjects with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all~     inclusion and no exclusion criteria will be randomized. All subjects will be at least 12~     years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of~     CAP-1002 in three coronary arteries supplying the three major cardiac territories of the~     left ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the~     active treatment arm, all three major cardiac territories will be treated (infused) during a~     single procedure in an open-label fashion.~   "
43629|NCT02485925|"~     This is a prospective effectiveness and safety assessment of the study device during~     radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial~     fibrillation.~   "
43630|NCT02485912|"~     This is a clinical trial in which healthy volunteers will be administered two experimental~     Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with~     both vaccines one after the other in a prime/boost regimen.~      All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x~     10^8 pfu.~      All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7~     days later.~      The site of administration of the MVA-EBO Z vaccine differs between the two groups:~      Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.~      Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made~     from viruses which are modified so that they cannot multiply. The viruses have extra DNA in~     them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so~     that the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.~   "
43631|NCT02485899|"~     The Phase 1/2 study (190-201) evaluated the efficacy and safety of doses up to 300 mg/every~     other week (qow) BMN 190 in patients with CLN2. The dose and regimen for this study~     (190-202) are based on the results of the 190-201 study. The rationale for this phase 2~     extension study is to provide patients who complete the 190-201 study with the option to~     continue to receive continued BMN 190 treatment. The 190-202 study is an open label~     extension protocol to assess long-term safety and efficacy.~   "
43632|NCT02485886|"~     Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of~     physiological conditions. In particular, recent evidence suggests this type of macrophage~     response is important for the disease pathology of pulmonary fibrosis. Because cysteine~     cathepsins are proteases that are highly expressed in antigen presenting cells such as~     macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents~     68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential~     to not only aid early detection but also significantly aid efforts to monitor progression~     and patient response to therapy.~   "
43633|NCT02485873|"~     To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin~     K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation~     (SPAF) in a real-life setting~   "
43634|NCT02485860|"~     The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires~     regular dressings (daily for 15 days and then every 48 hours) until complete healing. This~     healing is obtained on average in 68 days. Some patients have difficulties in healing with a~     final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary~     wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing~     is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of~     honey in pilonidal cysts is not evaluated and may accelerate healing.~   "
43635|NCT02485847|"~     The IRIS™ Registry (Intelligent Research in Sight) is the nation's first comprehensive eye~     disease clinical registry. The American Academy of Ophthalmology is developing it as part of~     the profession's shared goal of continual improvement in the delivery of eye care.The IRIS~     Registry will be a centralized system for ophthalmology practices to promote practice~     innovations and achieve clinical excellence.~   "
43636|NCT02485834|"~     This randomized phase II trial studies how well fludeoxyglucose F-18 (FDG)/positron emission~     tomography (PET) directed treatment improves response in patients with stomach or~     gastroesophageal junction cancer that has not spread past the stomach and is not responding~     to the usual treatment. PET scans are a different way to take pictures of cancer and can be~     used to look at how much energy (such as glucose) is being used by the cancer. Using PET~     scans early to monitor the success of treatment may allow doctors to measure response and~     change treatment accordingly.~   "
43637|NCT02485821|"~     To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor~     induction.~   "
43642|NCT02485756|"~     Previous studies have shown that women on anti-seizure medications are not informed about~     the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs,~     AEDs) and certain hormonal contraceptive. The goal of this proposed study is to develop and~     assess the efficacy of an educational handout for participants on the ways AEDs and certain~     hormonal contraceptives can interact to alter effectiveness of the medications. Reproductive~     age women (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a~     patient agrees to participate, she will be given a knowledge exam prior to the clinic~     appointment to establish baseline understanding of hormonal contraceptive and AED~     interactions and then the participant will be randomized to receive the intervention~     (educational handout) or the standard of care (no educational handout). Those in~     participants in the intervention group will read an educational handout on hormonal~     contraceptives/AED interactions. Those in the standard care group will not receive this~     handout and the same knowledge exam will be re-administered to all of the participants after~     they have completed their appointments to check for knowledge comprehension and short-term~     knowledge retention. A same-day post-test questionnaire will evaluate participant's~     intention to discuss hormonal contraceptives/AED interactions with their gynecologist,~     neurologist or primary care physician.~   "
43643|NCT02485743|"~     This multi-centre, randomised controlled trial will be conducted over 24-weeks to evaluate~     the effect of a healthy diet supplemented with a product specifically developed (SATIN~     satiety products) to enhance feelings of satiety and reduce food intake after an initial~     weight loss period to assess weight maintenance. Participants will either receive the active~     SATIN product or a matched control product. The products contain ingredients which have been~     shown to positively affect satiety, satiation and/or body weight and are all accepted food~     ingredients approved for human consumption in Europe. They will be incorporated into~     different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products~     without the active ingredients will be provided to participants allocated to the control~     group. The participants will be instructed in detail on how and when to consume the test~     products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at~     three research sites (University of Liverpool, United Kingdom; University of Copenhagen,~     Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites.~     Participants will attend assessments at one of the three research sites continually~     throughout the study period. The primary outcome will be weight maintenance after low~     calorie diet as assessed by weight, waist circumference, body composition (DXA), energy~     intake and subjective appetite assessments made at study test sessions. Secondary outcomes~     include assessing biomarkers of health outcomes (blood and urine indices), changes in~     physical activity as well as consumer benefits of the trial (assessed in a range of~     questionnaires) to determine diet efficacy.~   "
43644|NCT02485730|"~     The ALFA study is a long term, prospective, observational study of AD patients' adult~     children aimed to study and characterize key physio-pathological features of the preclinical~     phase of AD.~   "
43645|NCT02485717|"~     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo~     for the clinical cure of scabies after a single treatment. The trial will also assess the~     the safety and efficacy of of open-label Natroba for the clinical cure of subjects who~     demonstrated treatment failure after the blinded first application of spinosad or placebo.~   "
43646|NCT02485704|"~     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo~     for the clinical cure of scabies after a single treatment. The trial will also assess the~     the safety and efficacy of of open-label Natroba for the clinical cure of subjects who~     demonstrated treatment failure after the blinded first application of spinosad or placebo.~   "
43647|NCT02485691|"~     Primary Objective:~      To compare the radiographic progression-free survival (rPFS) of chemotherapy (cabazitaxel~     plus prednisone, Arm A) versus AR-targeted therapy (enzalutamide or abiraterone acetate plus~     prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had~     disease progression while receiving AR-targeted therapy within 12 months of AR treatment~     initiation (≤12 months, either before or after docetaxel).~      Secondary Objectives:~        -  To compare efficacy for:~        -  Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).~        -  Progression-free survival (PFS).~        -  Overall survival (OS).~        -  Tumor response rate and duration of tumor response.~        -  Pain response and time to pain progression.~        -  Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.~        -  Health status and Health-related Quality of Life (HRQOL).~        -  To evaluate the correlation of a signature of resistance to AR-targeted agents with~          clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as~          expression and localization of proteins including AR isoforms in CTCs.~        -  To evaluate safety in the 2 treatment arms.~   "
43648|NCT02485678|"~     Comparison of the number of ER plus hospital visits that occurred during chemotherapy~     between the telephone intervention and control arms.~   "
43649|NCT02485665|"~     To evaluate the efficacy of postoperative pelvic floor muscle training using personalized~     extracorporeal biofeedback device among patients with post-prostatectomy incontinence~   "
43650|NCT02485652|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of~     HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment~     with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).~   "
43651|NCT02485639|"~     The primary objective investigate the longevity of humoral immunity to influenza virus in~     humans. Our overarching hypothesis is that an understanding of how long-term humoral~     immunity to influenza virus is generated and maintained is essential for the development of~     a universal vaccine against influenza virus. The secondary objective is the longitudinal~     tracking of vaccine-induced B cells responses with special emphasis on broadly neutralizing~     HA stem reactive responses.~   "
43652|NCT02485626|"~     The purpose of this study is to evaluate the prevalence of (sub)clinical cardiovascular~     disease, cardiovascular risk factors and metabolic abnormalities among long-term breast~     cancer survivors treated with or without anthracyclines in order to identify patients at~     increased risk of developing cardiovascular disease.~   "
46063|NCT02454062|"~     A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety,~     Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with~     S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.~   "
43653|NCT02485613|"~     Although the use of bortezomib has reported efficacy in amyloid light chain (AL)~     amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of~     patients with AL amyloidosis should be determined. In this study, the investigators~     evaluated the efficacy and safety of BD as the first-line treatment of patients with AL~     amyloidosis.~   "
43654|NCT02485600|"~     This is an open-label, postmarketing, observational study to document health outcomes, in~     Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa~     (levodopa/carbidopa intestinal gel).~   "
43655|NCT02485587|"~     The purpose of this study is to determine whether individualized biofeedback of arousal~     (skin conductance) is effective in the treatment of aggressive behavior problems in children~     and adolescents with either predominantly impulsive (reactive) and/or high callous~     unemotional traits (proactive) subtypes of aggression when compared to treatment as usual~     (TAU), and induces normalization when compared to a group of typically developing children~     receiving no intervention.~   "
43656|NCT02485574|"~     The purpose of this study is to evaluation for the pattern of bone bridging of patients who~     undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto~     local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not~     inferior to auto local bone only. In addition, the investigators will analyze anterior new~     bone bridging pattern between anterior bridging cage newly developed and grafted bone in~     anterior disc space.~   "
43657|NCT02485561|"~     This is a study examining the effects of different educational-motivational materials about~     colorectal cancer screening on perceptions and intentions to get screened. Eligible~     participants will be randomized to one of three experimental conditions. All participants~     will be provided information about colon cancer and screening options based on the Centers~     for Disease Control and Prevention (CDC's) Screen for Life materials. Some participants also~     will be asked to read a personal narrative about colon cancer screening. This study will~     determine whether participant's perceptions about and colorectal cancer screening intentions~     and behaviors differ by which information they read. Participants will complete surveys~     before, immediately after, and one month after randomization. Participants can complete all~     study requirements through the study website: http://HealthStudy.wustl.edu~   "
43658|NCT02485548|"~     This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and~     toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for~     patients with locoregionally advanced head and neck squamous cell cancer.~   "
43659|NCT02485535|"~     This phase I trial studies the side effects and best dose of selinexor when given after stem~     cell transplant in treating patients with acute myeloid leukemia that is at intermediate or~     high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic~     syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to~     stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill~     cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.~   "
43660|NCT02485522|"~     Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging~     from 7-15% in community dwelling women. FI has an immense impact on quality of life and is~     associated with increased care giver burden, increased rates of institutionalization, and~     significant cost burden in older women. Traditionally believed to be primarily caused by~     child birth injury, recent studies show that the typical age of onset of FI is age 40 which~     is remote from child birth. Treatment options for FI are limited because the mechanism~     underlying FI in older women are poorly understood. The overriding goal of this project is~     to investigate the relationship between diet, stool metabolites and fecal incontinence.~   "
43661|NCT02485509|"~     A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in~     healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.~   "
43662|NCT02485496|"~     The purpose of this study is to evaluate clinical and technical success as well as safety~     and feasibility of the E-tegra Stent Graft System used in endovascular treatment of~     infrarenal aortic aneurysm.~   "
43663|NCT02485483|"~     The purpose of this study is to validate standardized questionnaires on depression for RA~     and to investigate the frequency of depression with RA. The study will include 2 parts,~     VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval~     of 3 months regarding their current emotional condition using standardized questionnaires.~     On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be~     used to assess the prevalence of depression with RA in approximately 1000 participants.~   "
43664|NCT02485470|"~     The goal of this study is to test, in a randomized controlled trial among head and neck~     cancer patients, the short and longer term effects of the MPACT (Maintaining Physical~     Activity during Cancer Treatment) program (infused with motivational interviewing and~     self-determination theory-based strategies) initiated at the time of concurrent chemotherapy~     with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and~     ultimately physical activity. The central hypotheses is that in head and neck cancer~     patients undergoing CCRT, the MPACT program, as compared to usual care controls, will result~     in less acute decline, faster recovery, and better maintenance of these key outcomes.~   "
43665|NCT02485457|"~     The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output~     monitor) to detect stroke volume variation induced by leg raising or fluid expansion during~     surgery~   "
43666|NCT02485444|"~     This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at~     induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or~     observation with no pharmacologic intervention. Primary outcome of the study is complete~     abortion rate within two hours of fetal delivery.~   "
43667|NCT02485431|"~     This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed~     to assess the comparative bioavailability and food effect of deflazacort. A total of 45~     subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing~     sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a~     crossover fashion.~   "
44402|NCT02475850|"~     The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an~     evidence-based, patient-centered multifactorial fall injury prevention strategy in community~     dwelling older adults at risk of falls recruited from 86 primary care practices around the~     U.S.~   "
43668|NCT02485418|"~     Propofol has been used in adult populations to treat migraines as an abortive agent.~     Investigators plan to investigate its efficacy as an abortive agent in the pediatric~     population when administered as a safe low-dose infusion. Goals of the study are to:~        1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric~          migraine headaches~        2. Evaluate effective and safe dosing limits in pediatric populations~        3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive~          agent~      Endpoints for the study will be:~        1. Number of enrolled patients~        2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence~          Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol~          under the guidance and supervision of a board certified pediatric anesthesiologist with~          the appropriate monitoring equipment and readily available emergency equipment.~          Investigators hope to demonstrate more rapid improvement and decreased side-effect as~          compared to standard care.~   "
43669|NCT02485405|"~     The purpose of this study is to analyse gut permeability and stress.~   "
43670|NCT02485392|"~     A single-blinded randomized clinical trial (RCT) designed to compare Single-Site~     robot-assisted with single-incision laparoscopic cholecystectomy. The study directly~     compares both surgical approaches in a cohort of 60 patients (30 patients in each arm) with~     benign gallbladder disease from the Department of Surgery at the Cantonal Hospital of~     Winterthur (Kantonsspital Winterthur) in Switzerland. The primary endpoint of the study is~     the surgeon's physical and mental stress load at the time of surgery and is assessed by~     validated Local Experienced Discomfort (LED) and Subjective Mental Effort Questionnaire~     (SMEQ) visual analogue scales. The secondary endpoints include costs of the procedure,~     intra-operative blood loss, operating time, intra-operative conversion rate and additional~     trocar placement, complications, length of hospital stay, Health-Related Quality of Life~     (HRQoL) and cosmesis. HRQoL and cosmesis will be assessed using the validated~     Gastrointestinal Quality of Life Index (GIQLI) and the Body Image Questionnaires (BIQ),~     respectively. The inclusion criteria cover most notably symptomatic cholecystolithiasis,~     chronic cholecystitis, benign gallbladder polyps and age ≥18 years. The exclusion criteria~     are, among others, acute cholecystitis, emergency cholecystectomy, previous extensive upper~     abdominal surgery and suspicion of malignant disease. Non-stratified block randomization~     (random block sizes 2 and 4) will be used to achieve balance in the allocation of~     participants to both treatments arms and prevent a premature decoding of the randomization~     scheme. Hereby, the patient will not be informed about the group assignment until the last~     outpatient follow-up and only after he/she has completed and returned all required~     questionnaires (GIQLI and BIQ). The operation will be performed according to the group~     assignment by senior surgeons only who have a wide experience in both robotic Single-Site~     and conventional single-incision laparoscopy. All data are recorded safely using the~     SecuTrialTM program. Sample-size calculations are based on the results of the previously~     mentioned experimental setup by Schatte et al, utilizing an estimated effect size of 0.8, at~     a power of 0.8 and an alpha-error level of 0.05, as well as considering a potential~     additional error margin of 10-15% of the calculations (G-Power 3.1 software, Heinrich-Heine~     University Duesseldorf/Germany). The estimated total duration of the study is 1.5 years,~     including the scheduled 1-month and 1-year postoperative follow-up visits. The study will be~     carried out in accordance with principles enunciated in the current version of the~     Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by~     International Conference on Harmonization (ICH), and Swiss regulatory authority's~     requirements.~   "
43671|NCT02485379|"~     Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of~     suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific~     Antigen (PSA) level, it is currently recommended to perform blinded systematically~     distributed biopsies with 10-18 samples obtained from predefined locations in the gland.~      These so-called systematic biopsies (SB) may lead to improper patient management by (i)~     missing clinically significant cancer, especially in the anterior half of the gland that~     tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer~     foci that may result in overtreatments, (iii) undersampling the tumor foci and thus~     underestimating their volume and aggressiveness.~      Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in~     detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that~     targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive~     cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the~     aggressiveness of detected cancers than SB. However, these monocenter studies only provide~     low-level evidence and three recent independent reviews of literature concluded that there~     was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared~     to SB. This is particularly important since many academic and private centers in France~     already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that~     this approach becomes the norm without being properly evaluated and it is crucial and urgent~     to perform a controlled multicentric study to provide high-level evidence as to whether~     mp-MRI should or should not be obtained before prostate biopsy.~      One controlled multicentric study has been published recently in which SB and TB had been~     obtained by two different operators in 95 patients. TB yielded a significantly higher~     detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant~     cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients~     with negative mp-MRI were not included.~      Research hypotheses: There is currently no robust multicenter trial comparing prostate TB~     based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre~     prospective trial comparing the results of SB and TB performed in the same patients by two~     independent operators. Our hypothesis is that TB detect aggressive (Gleason ≥7) cancers in a~     significantly higher percentage of patients than SB.~      Main objective: Compare the percentage of patients with clinically significant cancer~     (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.~   "
43672|NCT02485366|"~     Blood transfusion is nearly always needed during open heart surgery in children less than 15~     kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the~     organs and tissues of the body. Stored blood undergoes some changes that may make it less~     effective in achieving this goal. The purpose of this study is to see if restoring important~     energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused,~     with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard~     blood transfusion. This is a Food and Drug Administration (FDA) approved process that is~     described by the American Association of Blood Banks for prolonging blood storage but not~     used for everyday transfusions. The investigators want to use this process to improve blood~     transfused to children undergoing heart surgery.~      Although Rejuvesol has been previously approved by the FDA, it is not routinely used to~     prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this~     study is considered investigational. This is a pilot study and data will be collected for~     future protocol development.~   "
43673|NCT02485353|"~     This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the~     treatment of adults 60 years of age or older with previously untreated acute myeloid~     leukemia. A total of 17 evaluable patients are planned to be treated on the study.~   "
43674|NCT02485340|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide~     (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug~     candidates.~   "
43675|NCT02485327|"~     Primary Objective:~      To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to~     insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM~     patients in a euglycemic clamp setting.~      To characterize the within-subject variability in the metabolic activity (pharmacodynamic~     [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic~     clamp setting.~      Secondary Objectives:~      To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~      To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~      To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~   "
43676|NCT02485314|"~     The Participation and Environment Measure for Children and Youth (PEM-CY) is the first~     instrument that combines parental assessment of children's participation in home, school,~     and community activities with qualities of each environment that are perceived to support or~     hinder participation. This combined format may help to clarify the relative impact of~     environmental factors (including the natural and built environment), compared to personal~     factors, on children's participation in specific settings. The aim of this study was to~     examine reliability and validity of Turkish version of the Participation and Environment~     Measure for Children and Youth (PEM-CY).~   "
43701|NCT02484989|"~     Currently, there is little recent data on regional variations in treatment methods, neonatal~     units that provide retinopathy (ROP) treatment, facilities for treatment available at each~     unit including anaesthetic support for such preterm babies, facilities to transfer babies to~     units that offer treatment etc. While some parts of the UK have established neonatal~     networks and agreements among units for ROP treatment, in other parts, such arrangements are~     illdefined.~      The number of babies needing ROP treatment may be higher since the introduction of revised~     guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting~     epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the~     incidence of treatable ROP, the treatment methods used and facilities for treatment will~     provide the foundation for effective planning of resources and manpower to deal with the~     additional demand.~   "
43677|NCT02485301|"~     The purpose of this study is to assess the safety and immunogenicity of the investigational~     ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose~     Considering the risk of exposure to Ebola and the potential (based on animal data) for the~     investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in~     the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group~     EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group~     Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the~     investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised.~     In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z~     vaccine will allow an increase of the safety database of the investigational vaccine. In~     case the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any~     of the regions where this trial is conducted, earlier administration of the investigational~     ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that~     region.~   "
43678|NCT02485288|"~     The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical~     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer~     questions of clinical importance to patients, providers, and other stakeholders.~   "
43679|NCT02485275|"~     The purpose of this study is to explore the value of new imaging technique package in~     predicting early neurological deterioration and early recurrence of stroke in patients~     within 72 hour of stroke onset.~   "
43680|NCT02485262|"~     Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease~     worldwide. The virus successfully evades host immune detection and has highly restricted~     requirements for growth in vitro that for many years hampered efforts to find a safe,~     uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated~     interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care~     (1-5). PR therapy offered limited performance and availability across the diverse spectrum~     of HCV disease and was fraught with excessive and often limiting side effects. The first~     direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and~     could only be used only in combination with PR because of concerns for rapid PI viral~     resistance. Although the first generation PIs added increased efficacy to the PR regimen,~     they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a~     potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The~     drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV~     DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral~     genotypes, disease stages, and special patient groups such as those co-infected with HIV.~     When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV~     treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained~     virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for~     genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor)~     showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to~     date, SOF offers the widest applicability for all infected patients yet can be given in a~     personalized regimen to maximize performance~   "
43681|NCT02485249|"~     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate~     ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients~     with macular edema (ME)~   "
43682|NCT02485236|"~     The study aims to compare the efficacy of Nasal High Flow Therapy (NHF) with low-flow oxygen~     supplementation in improving postoperative intermittent desaturations. If so, this mode of~     therapy would provide a cost effective, relatively easy to implement, and better tolerated~     treatment to Continuous Positive Airway Pressure (CPAP) for oxygen stabilization.~   "
43683|NCT02485223|"~     This is a pilot study (a small scale study testing procedures so that the investigators can~     apply this to a larger scale study). This study will test the accuracy of a new brain scan~     (Magnetic Resonance Imaging) technique in predicting the diagnosis of multiple sclerosis~     (MS) in patients where there is uncertainty about the diagnosis. For patients where there is~     a suspicion (but not definite) diagnosis of MS, an additional MRI brain scan will be~     offered. There will be no other research tests and the patient is followed up to see what~     the eventual diagnosis is. The investigators will then review the original brain scan to see~     if this predicted the diagnosis of MS or not.~   "
43684|NCT02485210|"~     The elimination of pathogenic microorganisms from the root canal system is one of the main~     points in order to have success in endodontic treatment. The objective of this study is to~     perform a randomized controlled clinical trial to compare the effectiveness of success in~     endodontic treatment of primary teeth when combined with photodynamic therapy. Will be~     selected 30 primary teeth of children aged between 3 and 6 years. The teeth will be divided~     into two groups: group I control, which will be applied the conventional endodontic~     treatment and group II to be held endodontic treatment with application of photodynamic~     therapy. In both groups will be made microbiological evaluations before and after endodontic~     treatment and clinical and radiographic evaluations will be conducted in the day, 1 month, 3~     months and 6 months after treatment comparing the treatment performed in both groups.~   "
43685|NCT02485197|"~     This is a small pilot aerobic training trial designed to examine differences between~     normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by~     non-invasive Hybrid Diffuse Optical Spectroscopy.~   "
43686|NCT02485184|"~     Occlusive portal vein thrombosis may be a negative prognostic marker of variceal bleeding in~     liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy,~     transjugular intrahepatic portosystemic shunt may further improve the outcomes of occlusive~     portal vein thrombosis in liver cirrhosis with variceal bleeding.~   "
43687|NCT02485171|"~     The main objective of this study is to evaluate the feasibility and acceptability of the use~     of the robot SAFEWALKER complement classical rehabilitation in a group of elderly patients~     over 70 years during the rehabilitation of post-fall syndrome.~   "
43688|NCT02485158|"~     The purpose of this study is to examine whether individual differences in acute responses to~     drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and~     delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who~     experience greater rewarding effects from one drug will also experience more rewarding~     effects from the other drugs.~   "
43702|NCT02484976|"~     BASIC fMRI is a prospective single center intervention trial using fMRI imaging in 9-11 year~     old obese male and females pre and post family-based behavioral treatment of 24 weeks~     duration to determine the relationship between impulsivity and central satiety responses.~   "
44416|NCT02475668|"~     Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry~     systems.~   "
43689|NCT02485145|"~     Osteoarthritis (OA) affects over 30 million people in the United States and represents our~     nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA~     raised overall health care costs by $185.5 billion annually. Largely as a consequence of~     this disease, the number of patients undergoing joint replacement surgery will quadruple~     over the next 17 years. Importantly, several recent studies have demonstrated that OA is an~     independent risk factor for cardiovascular disease . Presently investigators have no~     medications that alter the natural history of OA. Weight control, exercise and some physical~     therapy measures are the only interventions short of total joint replacement that alter the~     course of this disease. To make matters worse, investigators have experienced only setbacks~     in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal~     anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently~     available armamentarium for pain control in OA . Clearly OA is a major factor that demands~     better solutions as the health care system is redesigned.~      OA involving the hands represents a major part of the overall burden of this disease. In~     radiographic surveys about a quarter of the total US population has changes consistent with~     OA involving the hands. Among the elderly, radiographic hand OA has been found in over half~     of such individuals and as many as a quarter of them suffer from pain and functional~     incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint,~     the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints .~     Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs),~     and a variety of physical measures such as physical therapy, bracing, and heat and cold~     applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical~     therapies have been developed which either act as counter irritants, seek to reduce~     substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading~     example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and~     improve hand function in a double blind controlled trial. However none of these measures~     have proven sufficiently effective to meet patient needs. Topical polytherapy will be~     employed in this study to see if it will be effective against the pain of OA.~   "
43690|NCT02485132|"~     Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is~     known about the real frequency of asymptomatic or unreported hypoglycemia and their impact~     on glycemic control and quality of life among patients using sulfonylureas (SUs). The~     frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose~     (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of~     hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.).~     No previous studies have reported total hypoglycemia as measured by continuous glucose~     monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true~     incidence of these events. As with age hypoglycemia perception is reduced and consequences~     can be increased due to frailty, elderly could be especially sensitive to the risk of~     hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to~     really appreciate the potential impact of SUs in the Canadian context.~      The investigators propose a multicenter observational prospective study in order to study~     the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus~     (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing~     (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and~     after a 3 months follow-up of treatment, including medical history measures, quality of life~     and diabetes treatment satisfaction.~      In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the~     objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia~     as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period~     following the initiation of the SU.~   "
43691|NCT02485119|"~     The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability~     and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with~     advanced, refractory solid tumors.~      The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.~   "
43692|NCT02485106|"~     This study aimed to investigate the effect of decontamination by rifaximin in severe~     alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be~     randomly allocated to rifaximin group or control group.~   "
43693|NCT02485093|"~     Optimal pacing strategy for patients with SND is still unknown, although several~     publications in the past years demonstrated a deleterious effect of ventricular pacing.~     However, pacing has always been apical in these trials, and to which extent this absence of~     pacing is beneficial for patients with very long PR intervals is still to be found.~      The aim of this study is to compare ventricular septal pacing to no pacing in patients with~     SND.~   "
43694|NCT02485080|"~     The goal of this pilot study is to examine both efficacy and tolerability in patients with~     HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT~     score is used to assess the prognosis of chronic liver diseases, as well as the required~     strength and treatment and necessity of liver transplantation. A higher CPT score denotes~     higher necessity of liver transplantation.~   "
43695|NCT02485067|"~     The primary purpose of this study is to assess the efficacy and safety of~     THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder~     during the period of treatment, 12 weeks.~      This study also includes an open label extension period of an additional 12 weeks following~     the treatment to assess long-term efficacy and safety of THVD-201 in patients with~     Overactive bladder.~   "
43696|NCT02485054|"~     The transient visual disturbances (TVD) are defined by a short abnormality of visual~     function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic~     origin.~      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.~      A clinical score could help the clinician to recognize the etiology of the TVD .~   "
43697|NCT02485041|"~     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg~     mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was~     compared between the two drugs.~   "
43698|NCT02485028|"~     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg~     mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was~     compared between the two drugs.~   "
43699|NCT02485015|"~     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with~     cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with~     advanced gastric cancer.~   "
43700|NCT02485002|"~     This study will include patients aged between 18 and 65 who will undergo retrograde~     infrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female)~     will be recruited, and will be randomized into 2 groups consisting of 30 patients in each~     group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS)~     positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of~     UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether~     using UAS or not affects the kidney functions. besides the routine kidney function tests,~     namely urea and creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more~     specific and early marker of kidney function) will be used to assess the differences in the~     kidney functions. Preoperative blood urea and creatinine levels and urine NGAL levels will~     be studied for all patients. After the surgery, blood urea and creatinine levels will be~     again studied as well as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st~     week.~   "
43724|NCT02484690|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716~     in participants with subfoveal CNV secondary to AMD.~   "
43703|NCT02484963|"~     All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary~     Sciences will be screened for sleep disturbance and excessive daytime sleepiness with~     Epworth sleep score/ Pittsburgh sleep quality index. 50 patients of clinical/ radiological/~     biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of~     psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7~     questionnares. Patients who are suffering with sleep disturbance as evaluated with~     Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two~     groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive~     zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed~     time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients~     will be reassessed with PSQI and polysomnography. All patients will be advised regarding~     sleep hygiene.~   "
43704|NCT02484950|"~     The primary objective of this study is to compare the clinical outcomes of arthroscopic~     rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).~     Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines~     and by supplying growth factors to their implanted environment. They have been shown to be~     effective in improving both overall healing and tendon integrity in rotator cuff repair.~     This study will follow 100 patients in the United States and track their clinical outcomes~     for at least one year post-operatively.~   "
43705|NCT02484937|"~     This study will demonstrate that functional improvement measures over a 6-month period for~     chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic~     plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those~     under the care of the PMS only. Chronic low back pain patient will be initially be evaluated~     by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan~     (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low~     back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will~     be treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated~     by their own PCP for monthly visits for 6 months.~   "
43706|NCT02484924|"~     A retrospective real world analysis of bleeding events with ticagrelor compared to~     clopidogrel in ACS patients.~   "
43707|NCT02484911|"~     The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in~     combination with olanzapine ,palonosetron and dexamethasone for the prevention of~     chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately~     emetogenic chemotherapy.~   "
43708|NCT02484898|"~     The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the~     clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac~     Telemetry System/External Cardiac Monitor System (MCT/ECM).~   "
43709|NCT02484885|"~     Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe MRI and pulmonary function~     testing for the development of tools to assess image signal to noise and reproducibility of~     spin-density and diffusion-weighted imaging.~   "
43710|NCT02484872|"~     Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the~     Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim~     of the study is to look at the prognostic and predictive value of inflammation during cancer~     evolution, on the risk of complications leading to ICU admission and the risk of death.~   "
43711|NCT02484859|"~     Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic~     sinusitis refractory to medical treatment, nasal polyposis, mass lesions in the nasal~     cavity. The purpose of this study is to determine whether tramadol and metoprolol are as~     effective as remifentanil in providing controlled hypotension during FESS.~   "
43712|NCT02484846|"~     Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions~     that were at least five days apart. The first session was a baseline. The sleep intervention~     took place on the night prior to Session 2, where the amount of time in bed was manipulated~     to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective~     (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness~     were measured. During the middle of each session, a 40-minute ad libitum meal opportunity~     allowed participants to eat from eight different food items. Food healthfulness, caloric~     density, distribution and number of calories were measured and compared to alertness levels.~   "
43713|NCT02484833|"~     -  To investigate whether cetuximab alone (given until progression or cumulative toxicity)~          after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free~          Survival when compared with continuous FOLFIRI + cetuximab (given until progression or~          cumulative toxicity).~        -  To assess whether an improvement in the incidence of grade 3-4 hematological and~          non-hematological adverse events (AEs) can be achieved in the experimental arm~          (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous~          chemotherapy arm (FOLFIRI plus cetuximab)~        -  To explore the possibility of using liquid biopsies for molecular profiling as well as~          monitoring treatment activity in mCRC pts receiving cetuximab based therapy~   "
43714|NCT02484820|"~     In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a~     premature birth in 25.4% of cases.~      After 48 hours effective tocolysis, patients do not receive any further treatment while~     their risk of premature birth has risen from 6.5% to 25%.~      A pessary is a silicone ring encircling the cervix. It was initially used as medical~     treatment of genital prolapse but studies were also conducted for pregnant women in 2~     high-risk premature birth situations: cervical incompetence and twin pregnancies.~      The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients~     between 18 and 22 weeks of gestation showed a significant reduction of premature birth~     before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries~     in patients presenting a resolutive threatened preterm labor will also be effective.~      To evaluate this hypothesis, the investigator designed a randomized prospective~     single-center open clinical trial comparing pessary associated with standard care (1st~     group) versus standard care only (2nd group) in patients experiencing an episode of~     resolutive threatened preterm labor.~   "
43795|NCT02483754|"~     The study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military~     retirees and to analyze the associated risk factors. As such, MOCA was revised to be~     validated for the Chinese context.~   "
43715|NCT02484807|"~     The development of disease-targeted medication for the treatment of pulmonary arterial~     hypertension (PAH) has significantly improved within the last years, leading to the~     development of 10 approved agents. Combination treatment with~     Endothelin-Receptor-Antagonists (ERA) and Phosphodiesterase-Type-5-Inibitors~     (PDE-5-Inhibitor) has become increasingly important for the treatment of PAH. In a recent~     press release, the results of the AMBITION study reported that an upfront combination~     treatment immediately after diagnosis leads to a delayed disease progression [4]. Thus, the~     question if there is a clinically relevant pharmaco-dynamic drug-drug interaction is of~     rising interest.~   "
43716|NCT02484794|"~     Cognitive behavioural therapy (CBT) is the most empirically supported and researched~     treatment for eating disorders. A central component of CBT for eating disorders is~     self-monitoring which involves patients keeping a paper food record of their meals and~     associated thoughts, feelings, and behaviours and receiving feedback from a clinician to~     help target dysfunctional cognitions and behaviours. Given the issues associated with paper~     journals such as non-compliance, feelings of shame when used in public, and delayed~     feedback, researchers have developed an evidence-based smartphone application (Recovery~     Record) for eating disorder self-monitoring that links patients with their clinicians and~     offers additional features designed to enhance treatment.~      The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone~     application in a clinical setting alongside standard eating disorder outpatient treatment.~     Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient~     Program and randomised to receive either standard treatment or standard treatment with the~     app (instead of the paper food record). The efficacy and acceptability of both treatments~     will be assessed and compared. Coping skill use and self-efficacy among patients will also~     be examined given the skill building focus of treatment and in-app capabilities to deliver~     real-time coping skill suggestions to patients.~      This pilot study will be the first to examine the efficacy and acceptability of a smartphone~     application in eating disorder clinical treatment and if successful, should provide~     preliminary support for the use of smartphone applications over traditional paper food~     journals as a self-monitoring tool for augmenting specialty eating disorder clinical~     treatment.~   "
43717|NCT02484781|"~     Total hip replacement surgery is a very successful operation with good long-term results.~     Hip resurfacing arthroplasty is offered as a treatment option for young and active patients~     with osteoarthritis of the hip. It has been proposed as a treatment option for younger~     patients because of claims that it preserves femoral bone stock and has better functional~     outcomes. The assessment of gait after hip replacement surgery may be able to determine~     functional differences between patients who have undergone total hip replacement /~     arthroplasty (THA) versus hip resurfacing.~   "
43718|NCT02484768|"~     The purpose of this study is to to establish proof-of-concept for efficacy of iron~     isomaltoside 1000 in subjects with Restless Legs Syndrome.~      The study is a randomised, comparative, double-blind study with a 3 months extension.~     Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following~     treat-ment groups:~        -  Group A (42 subjects): 1000 mg iron isomaltoside 1000~        -  Group B (21 subjects): Placebo infusion~      Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg~     iron isomaltoside 1000 at week 6.~   "
43719|NCT02484755|"~     The USP8 gene and its downstream target, epidermal growth factor receptor (EGFR), is a~     potential therapeutic target of Cushing disease. The EGFR inhibitor, Gefitinib, has been~     shown to reduce the production of ACTH both in vitro and in vivo, especially in USP8-mutated~     corticotrophin adenomas. The investigators hypothesize that Gefitinib will suppress~     pituitary corticotroph tumor ACTH production and normalize urinary free cortisol levels in~     patients with USP8-mutated Cushing's disease. Gefitinib is an FDA approved drug used to~     treat non-small cell lung cancer. However, in this study, the drug will be used to treat~     corticotrophin adenoma.~   "
43720|NCT02484742|"~     The main purpose of this study is to learn about the effects of repeated exposure to sleep~     disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep~     is shortened and disrupted, followed by a single night of recovery sleep) on inflammation,~     mood, and pain processing (experiences/perceptions of pain). Purpose of this research~     project is to understand the mechanisms of how sleep disruption may change mood and the~     experience of pain. Understanding those mechanisms is important to develop interventions~     that may help to reduce the effects of sleep disruption on mood and pain.~   "
43721|NCT02484729|"~     This study will be a randomized, single-blind, placebo-controlled first-in-human study in~     healthy male subjects to assess the safety, tolerability and pharmacokinetics of single~     ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along~     the gastro-intestinal tract will be investigated using the IntelliCap® system in a~     non-randomized, open-label, fixed-sequence design. The study will be performed at a single~     study centre.~   "
43722|NCT02484716|"~     Timolol is a nonselective β-blocker commonly used in the treatment of glaucoma. Recently it~     has been used topically for the treatment of superficial hemangiomas. Because of its~     potential mechanism of action, it is possible that timolol could also be useful for the~     treatment of epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Moreover a case was~     reported in 2012 showing an improvement of nosebleeds with the use of topical nasal timolol.~     The aim of the study is to evaluate timolol nasal spray efficacy in HHT.~      The main objective of this trial is to evaluate, 3 months after the end of the treatment,~     the efficacy on the duration of nosebleeds of a 4 weeks timolol intranasal treatment in HHT~     patients with nosebleeds (>20 min/month). Secondary objectives are to evaluate the~     tolerance, the efficacy at 6 months after the end of the treatment, and the efficacy on~     anemia and on clinical parameters (nosebleeds, quality of life and blood transfusions).~      This is a prospective double blind phase II study, randomized versus placebo using an~     allocation ratio of 1:1. A total of 58 patients will be included. The product (solution with~     timolol at 0.5% or placebo) is self-administered by the patient with a posology of one spray~     (50 µL) in each nostril twice a day for 28 consecutive days.~   "
43723|NCT02484703|"~     This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) and~     pharmacodynamic (PD) activity of 3 different dosages of RG1662 compared with placebo. Each~     arm will enroll approximately 9 children with Down syndrome between the ages of 6 and 11~     years to receive treatment for up to 26 weeks.~   "
43725|NCT02484677|"~     Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) is a mainstay for treating head and neck~     cancers, but elderly or fragile patients are often precluded because of the risk of severe~     toxicities associated with this protocol. DPD (Dihydro Pyrimidine Dehydrogenase) deficiency~     is a pharmacogenetic syndrome responsible for most of the severe/lethal toxicities showing~     in 5-FU (5-Fluorouracile)-treated patients, and our institute has developed a strategy for~     the routine determination of Dihydro Pyrimidine Dehydrogenase (DPD) status prior to starting~     giving the 5-FU so as to roughly adapt drug dosage according to the Dihydro Pyrimidine~     Dehydrogenase (DPD) status. This project aims at developing a Bayesian strategy to further~     individualize 5-FU dosing to reach a target exposure of area under curve (AUC). To this end,~     100 patients with head and neck cancer and scheduled for a Docetaxel, Cisplatin,~     5-Fluorouracile (=TPF) regimen will be included.~   "
43726|NCT02484664|"~     The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor)~     administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be~     recruited (between 4-8 at each site). The Specific Aims are:~      Aim 1: To investigate whether, in LAM patients, celecoxib is safe and well tolerated, and~     has evidence of clinical benefit.~      Aim 2: To investigate the potential value of a novel biomarker of LAM, quantitative~     measurement of the number of TSC2 mutant LAM cells per ml of blood, to assess disease~     severity.~   "
43727|NCT02484651|"~     The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular~     block throughout the entire surgical procedure followed by sugammadex reversal, would~     suppress EMG activity and result in improved anesthetic stability by reducing the~     variability of the Bispectral Index of the EEG, and be beneficial by reducing the total~     doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate~     level of anesthesia (BIS between 40 and 60).~   "
43728|NCT02484638|"~     The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety~     of rVIIa-FP (CSL689). The study will enroll a total of 54 male subjects, 12 to 65 years of~     age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study~     consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to~     evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the~     PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and~     Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2~     (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the~     best efficacy and safety in stopping acute bleeding events (this dose will be called the~     population best dose). The purpose of the final Part 3 (Repeated-dose part) is to confirm~     the efficacy and safety of the population best dose identified in Part 2. In Parts 2 and~     3, subjects will self-administer a specified number of CSL689 infusions at home on-demand~     (ie, when a bleeding event occurs), will keep an electronic diary, and will visit the center~     at monthly intervals. This study is expected to last for up to 16 months for the subjects~     participating in all 3 parts, and up to 9 months for the subjects participating in Part 3~     only.~   "
43729|NCT02484625|"~     Dairy products have a potential to be healthy snack foods for children and are provided in a~     variety of food matrices. For instance, milk represents a fluid product, yogurt can be~     classified as a semi-solid food, and finally cheese is the example of the solid food. This~     experiment is aimed to examine the effect of dairy products with different food matrices on~     satiety and food intake in children. Dairy products will be compared with other non-dairy~     snacks popular among children including cookies and potato chips.~   "
43730|NCT02484612|"~     Acute exercise has been shown to affect subsequent energy intake in obese adolescents.~     Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the~     individual maximal capacities) can reduce energy intake at the following meal in obese~     adolescents, with no modification of his appetite feelings.~      Although this results has been replicated several times, it remains unknown if those~     nutritional adaptations are due to post-exercise modifications of some gastro-peptides~     implicated in appetite control, as detailed in adults.~      The aim of this work is to question whether or not post-exercise energy intake is explained~     by appetite-regulating hormones that are affected by the exercise bout in both lean and~     obese youth.~   "
43731|NCT02484599|"~     The purpose of this study is to test the therapeutic effects of a computerized attention~     training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a~     computerized attention training can modify attention towards food and ameliorate eating~     disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore~     underlying mechanisms that contribute to these improvements. The stability of potentially~     observed effects over a one-month period will also be determined.~   "
43732|NCT02484586|"~     The aim of this study is to assess the visual performance of multiple optimised prototype~     soft contact lens designs compared to commercially available contact lenses.~   "
43733|NCT02484573|"~     This study seeks to investigate whether non-selective beta blocker treatment decreases~     intestinal permeability in cirrhotic patients by altering the expression of genes encoding~     intercellular junction proteins.~   "
43734|NCT02484560|"~     Duchenne Muscular Dystrophy (DMD) is a X-linked genetic disorder primarily affecting males,~     resulting in an absence of dystrophin which ultimately leads to progressive muscle~     degeneration. Patients with DMD progressively lose functional abilities of movement, breath,~     and eventually the ability to circulate blood. Currently, there is no cure for DMD, although~     several strategies are being tested for treatment, none have yet proven to be sufficient.~     Children with DMD are generally divided into two groups based on severity or progression of~     the disease, non-ambulatory and ambulatory. Ambulatory patients are capable of walking~     independently while non-ambulatory patients cannot walk independently.~   "
43735|NCT02484547|"~     The primary objective of the study is to evaluate the efficacy of monthly doses of~     aducanumab in slowing cognitive and functional impairment as measured by changes in the~     Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in~     participants with early AD. Secondary objectives are to assess the effect of monthly doses~     of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental~     State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13],~     and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment~     version) [ADCS-ADL-MCI].~   "
43736|NCT02484534|"~     Cirrhotic patients are patients with high morbidity and mortality, it is very important for~     determining the prognosis of these patients. The importance increases when these patients~     waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable~     measure of mortality risk in patients with end-stage liver disease. It is used as a disease~     severity index to help prioritize allocation of organs for transplant. MELD uses the patient~     values for serum bilirubin, serum creatinine, and the international normalized ratio for~     prothrombin time (INR) to predict survival.~      Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT)~     do not check actually the functioning of the system, but examine the level of clotting~     factors and therefore only verify that the side of Anticoagulant of the equation and not the~     side of the procoagulant .~      To examine the coagulation system function tests have been developed, One of them is the~     thrombin generation. The purpose of the trial is to determine whether thrombin generation~     test can be a prognostic indicator in patients cirrhosis.~   "
43737|NCT02484521|"~     PPI is an objective measure to assess pre-attentive processes that have already been tested~     before in the case of schizophrenia. The investigators aim to assess through this instrument~     two main characteristics, that the investigators assume are of relevance which are the~     duration of illness and the type of pharmaceutical treatment, patients receive.~      The investigators believe these two main characteristics are critical to the ability of the~     patients in improvement of their PPI response to startle reflex.~   "
43738|NCT02484508|"~     Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have~     inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the~     symptom of osteoporosis patients; and improve pain and limited joint activities of~     rheumatoid patients.~      To further verify the clinical effect of Guli capsule in the treatment of knee~     osteoarthritis, the investigators perform this multi-center clinical study.~   "
43739|NCT02484495|"~     The purpose of the study is to evaluate the impact of a package of interventions including~     production and distribution of locally produced complementary foods (via so-called~     Grain-banks) and Micronutrient Powders (MNPs) supplementation, and optimized food based~     Complementary Feeding Recommendation, on growth and micronutrient status of infants and~     young children. The impact of the intervention package will be evaluated in a~     quasi-experimental matched-control cluster design in infants and young children between 6 -~     29 months of age. The impact, outcome, and output indicators of infants/children will be~     assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair~     clusters are selected in which 15 households per cluster will be identified from the~     eligible population. A total of 1800 children from intervention and match-controlled~     clusters, will be sampled in the target age groups. Qualitative and quantitative data will~     be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and~     Young Child Feeding practices, anthropometry and anemia, following the impact pathway~     developed for the study.~      Research questions to be answered in this program evaluation are:~        1. What impact does the extended pilot (implementation of local complementary food~          production and MNP) have on:~             1. Growth in children 17-29 months of age~             2. Infant and Young Child Feeding practices in children (6-23m), and~             3. Anemia status in children 11-23 m?~        2. What are determining factors for the impact/no impact related to:~             1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and~               improved access~             2. Intermediate outcomes: utilization; provision, and ensuring enabling environment~             3. Program performance as measured by program monitoring data on output and~               activities?~   "
43740|NCT02484482|"~     The purpose this study investigate the effect of food on the~     pharmacokinetics/pharmacodynamics and safety of CKD-519~   "
43741|NCT02484469|"~     Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small~     group active learning in large group educational settings. When TBL is conducted correctly,~     the students' performances are equivalent or improved in comparison to either lecture-based~     formats or more traditional small group learning models.1 Nevertheless, few studies have~     been published regarding the insertion of innovative audiovisual tools in the TBL context.~     The Virtual Human Project is described as powerful sequences of three dimension (3D)~     computer graphics video of the human body that aids learning by facilitating an~     understanding in relation to a specific subject. The Virtual Human is composed by video~     sequences combining anatomy, physiology, and morphology in the context of various diseases.~     There are video sequences available for many disciplines, including dermatology and with~     capacity to produce anatomical structures by 3D printer. Despite the incredible potential~     applications of the Virtual Human, few studies have assessed its impact on medical~     education. The investigators did not find any study evaluating TBL with the insertion of~     iconographic educational material that assessed whether this intervention could change the~     learning progress of students. This is the aim of the present study, by comparing students~     tests scores after a TBL session with the VIrtual Human videos about leprosy or a standard~     TBL session, and to evaluate the student's satisfaction with the Virtual Human videos.~   "
43742|NCT02484456|"~     Background:~      - Drugs and talk therapy help treat depression, but these treatments usually take quite a~     bit of time to work. Ketamine is a fast-acting antidepressant, but it has side effects like~     unusual dreams and experiences. The drug AV-101 may have the same antidepressant effects but~     fewer side effects. Researchers want to see if it is effective and safe for people with~     major depressive disorder.~      Objective:~      - To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder.~      Eligibility:~      - Adults ages 18 65 with major depression without psychotic features.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants will stay in the hospital for 12 14 weeks.~        -  Phase 1 (2 7 weeks): participants will stop taking their medicines then not take any~          for 2 weeks. They will have several scans and other procedures.~        -  Phase 2 (6 7 weeks): 2 weeks each of study drug and placebo once a day, with 2 weeks of~          no drugs in between.~        -  Participants will have:~        -  Physical exams~        -  Interviews~        -  Frequent blood collection. A needle will place a small plastic tube in the arm. Some~          blood samples will be taken through this tube.~        -  2 spinal taps (optional). The back will be numbed. A needle will insert a catheter~          between back bones. That will be left in for up to 30 hours. Spinal fluid will be~          collected through it.~        -  5 scans. Participants will lie in a machine with a magnetic field. The machine takes~          pictures of the brain and brain chemicals.~        -  At the end of the study, participants will have medical evaluation, questions, and~          blood tests. Some may continue treatment at the clinic.~   "
43743|NCT02484443|"~     This phase II trial studies how well dinutuximab works when given with sargramostim in~     treating patients with osteosarcoma that has come back after treatment (recurrent).~     Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them.~     Sargramostim may help the body increase the amount of white blood cells it produces, which~     help the body fight off infections. Giving dinutuximab with sargramostim may work better and~     kill more cancer cells.~   "
43744|NCT02484430|"~     This phase II trial studies how well mTOR complex 1 and 2 (TORC1/2) Inhibitor INK128 works~     in treating patients with acute lymphoblastic leukemia that has returned after a period of~     improvement (relapsed) or has not responded to previous treatment (refractory). TORC1/2~     Inhibitor INK128 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
43745|NCT02484417|"~     Background:~      - Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be~     life-threatening, especially in young children, the elderly, and people with weak immune~     systems. Researchers want to study RSV infection in a hospital setting in healthy adults.~     They want to use what they learn to test new treatments or vaccines in the future.~      Objectives:~      - To study how the body responds to RSV.~      Eligibility:~      - Healthy volunteers ages 18-50~      Design:~        -  Participants will be screened under another protocol.~        -  Participants will have:~        -  Medical history~        -  Physical exams~        -  EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.~        -  Chest x-ray~        -  Pulmonary function tests. This measures how much air a person can move into and out of~          the lungs.~        -  Blood and urine tests~        -  Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile~          liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.~        -  Participants will have two, possibly three, follow-up outpatient visits, approximately~          1, 2 and 6 months after receiving the dose of RSV.~        -  Participants will stay in the hospital under isolation for 7 or more days after getting~          the virus.~        -  The average stay is 10 days. Participants cannot leave the isolation unit. They cannot~          have visitors.~        -  The virus should cause a mild to medium cold.~        -  Participants will fill out a symptom card every day in the hospital and for 1 month~          after.~        -  Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.~        -  Female participants who are sexually active must remain abstinent or use an effective~          form of birth control for 1 month before and after getting the virus.~   "
43746|NCT02484404|"~     Background:~      - MEDI4736 is a drug that may help people s immune systems respond to and kill cancer cells.~     Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a~     drug that may stop the blood vessel growth of cancer cells. This study has two components.~     In the phase 1 component of the study, researchers want to investigate how well participants~     tolerate the combination of these drugs in treating advanced solid tumors, and in the phase~     2 part of this study, researchers want to study if the combination treatments are effective~     in ovarian cancer.~      Objectives:~        -  Phase 1 part of the study: To determine the safety of the combination of MEDI4736 with~          the drugs olaparib or cediranib.~        -  Phase 2 part of the study: To determine how effective this combination is in treating~          ovarian cancer.~      Eligibility:~        -  Phase 1 part of the study: Adults age 18 or older with advanced or recurrent solid~          tumors that have no standard treatment.~        -  Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian~          cancer that has no standard treatment.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have CT or MRI scans. For these, they will lie in a machine that takes~          pictures of their bodies.~        -  Phase 2 part of the study requests the participants to have tumor samples removed.~        -  Participants will get MEDI4636 through an IV. A small plastic tube will be inserted~          into a vein. The drug will be given every 2 weeks for 12 months.~        -  Participants will take olaparib or cediranib by mouth every day.~        -  Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All~          other cycles, they will have 1 visit. At these visits, they will repeat the screening~          procedures.~        -  Patients will keep a drug and diarrhea diary.~        -  Patients on cediranib will monitor their blood pressure and keep a blood pressure~          diary.~        -  Participants who can become pregnant, or have a partner who can become pregnant, must~          practice an effective form of birth control.~        -  After 12 cycles, participants will have 1-3 months of follow-up.~   "
43747|NCT02484391|"~     This pilot phase II trial studies how well CPI-613 (6,8-bis[benzylthio]octanoic acid),~     cytarabine, and mitoxantrone hydrochloride work in treating patients with acute myeloid~     leukemia or granulocytic sarcoma (a malignant, green-colored tumor of myeloid cells [a type~     of immature white blood cell]) that has returned (relapsed) or that does not respond to~     treatment (refractory). 6,8-bis(benzylthio)octanoic acid is thought to kill cancer cells by~     turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and~     are the building blocks needed to make more cancer cells. By shutting off these~     mitochondria, 6,8-bis(benzylthio)octanoic acid deprives the cancer cells of energy and other~     supplies that they need to survive and grow in the body. Drugs used in chemotherapy, such as~     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving 6,8-bis(benzylthio)octanoic acid together with cytarabine and~     mitoxantrone hydrochloride may kill more cancer cells.~   "
43748|NCT02484378|"~     The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg~     CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque~     volume as measured by coronary IVUS, when administered to subjects presenting with Acute~     Coronary Syndrome (ACS) with significant plaque volume.~   "
43749|NCT02484365|"~     The preoperative evaluation including sampling blood in pediatric patients is hard to~     perform. However, the knowledge of the baseline cell blood count is important to prepare~     unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small~     children is often failed and sometimes induces iatrogenic blood loss and parent's~     complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide~     noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in~     pediatric patients during surgery and in ICU. However, the comparison for preoperative~     evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for~     preoperative preparation in pediatric patients.~   "
43750|NCT02484352|"~     Intravenous form of oxycodone is recently used for the adjunct of anesthetic agents to avoid~     adverse effects of the stimulation of endotracheal intubation. The potency ratio of~     oxycodone to fentanyl is not absolutely defined. The aim of this study was to assess the~     optimal dose of intravenous oxycodone for attenuation of hemodynamic responses to~     laryngoscopy and endotracheal intubation.~      A prospective, randomized, double-blind study was conducted. Ninety one patients were~     randomly divided into 5 group based on the dose of oxycodone; 0, 0.05, 0.1, 0.15, 0.2 mg/kg.~     After giving each assigned dose of intravenous oxycodone, anesthesia was induced with~     thiopental and rocuronium. Heart rate (HR) and blood pressure (BP) was collected at~     baseline, before intubation, 1, 2, 3 minutes after intubation. The change of BP was~     calculated by (highest BP after intubation - baseline BP)/baseline BP.~   "
43751|NCT02484339|"~     Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in~     combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in~     the treatment of advanced castration resistant prostate carcinoma with limited bone~     metastases.~      To evaluate if time to radiological progression according to the Recommendations of the~     Prostate Cancer Clinical Trials Working Group published by Scher et al. (JCO 2008) (based~     on new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with~     EBRT is superior compared to EBRT alone.~   "
43752|NCT02484326|"~     The purpose of this study is to validate a practical risk score to predict the mechanical~     complication of ST-elevation myocardial infarction (STEMI).~   "
43753|NCT02484313|"~     Dairy products have a potential to be healthy snack foods for children. The purpose of this~     project is to investigate the short-term effects of Greek yogurt, a new popular dairy~     product on the regulation of glucose homeostasis, satiety and energy intake in normal weight~     and overweight/obese children.~   "
43754|NCT02484300|"~     Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep~     apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory~     control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA~     severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent~     antioxidant. Melatonin production is suppressed when the eyes register light so people with~     healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards~     morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then~     extends later into the day. This abnormal pattern is thought to compound difficulty falling~     asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment~     in OSA patients are two-fold: most importantly via its antioxidant actions melatonin may~     reduce chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by~     normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake~     more refreshed.~   "
43755|NCT02484287|"~     The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD)~     related catheter infections by comparing the efficacy of Oklahoma University Medicine~     standard EVD catheters, both impregnated and non-impregnated, in three principle areas:~     incidence of infection, cost analysis, and average durations of placement, all while~     maintaining the standards of technique.~   "
43756|NCT02484274|"~     ID in children is the most frequent micronutrient deficiency in industrialized countries,~     including France. ID induces neurological impairment reducing cognitive, motor, and~     behavioral capacities in children in the short and long term.~      The purpose of this study is to evaluate the principal determinants of ID in France in~     two-year-old children and to improve strategies for prevention and screening.~      Our main objective is to study the association between iron status in two-year-old infants~     living in France and the consumption of toddler milk formula after taking non-dairy iron~     ingestion, parental socioeconomic status and educational level into account.~      Our secondary objectives are the following :~        -  to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.~        -  to improve clinical tools for ID screening. to improve strategies for laboratory~          screening.~   "
43757|NCT02484261|"~     This study aims to monitor patients for relapse of the leukemia following allogeneic~     Hematopoietic Stem Cell Transplantation (HSCT) in order to identify patients early in~     relapse, with a low burden of disease, when interventions may be more successful by~     monitoring of peripheral blood lineage specific chimerism. Once disease has been confirmed,~     patients will initiate a novel combination of bortezomib and pravastatin.~   "
43758|NCT02484248|"~     This study is a double-blind, placebo -controlled, cross-over trial of ketotifen in children~     ages 8 through 17 inclusive that have a diagnosis of Functional Dyspepsia and have had~     continued pain despite acid reduction therapy in combination with montelukast. This study is~     147 days for subjects responsive to the ketotifen and 63 days for those who are not. The~     study includes scheduled visits including a physical, blood draws, and questionaires.~   "
43759|NCT02484235|"~     Obesity is a global health problem since it is associated with many cardiovascular and~     metabolic diseases, osteoarticular problems and some cancers. That is why it is a priority~     of the national health policies. Exercise is a mainstay in the treatment, but still the most~     effective method is sought. The resistance exercise and high intensity intervals (HIIT) have~     been shown to positively affect the outcome of the disease, increasing the oxidative~     capacity of the trained subjects. Therefore it is important to look if both together produce~     greater benefits or otherwise nullify its effects, such as suggested by recent publications~     in relation to the cellular response to different stimuli such exercise in skeletal muscle.~     The aim of this study is to evaluate the effectiveness of interventions exercise high~     intensity intervals, overload and combining them in the oxidative capacity of obese~     subjects.~   "
43760|NCT02484222|"~     The purpose of this study is to discuss the relationship between the result of fentanyl test~     and required dosage of morphine for children with OSAS after adenotonsillectomy；and to~     evaluate the ability of predicting requested dosage of morphine postoperatively.~   "
43761|NCT02484209|"~     1. Many patients with type 2 diabetes are not at glycaemic goal and require additional~          therapy in order to reduce vascular risk and improve symptom control~        2. Sulphonylurea therapy is a commonly prescribed 2nd-line glucose -lowering agent and its~          use is recommended in major clinical guidelines for diabetes and also in the recently~          presented IDF (International Diabetes Federation) guidelines for older people.~        3. Older people with diabetes are not a homogeneous group and as many as 25% are frail.~        4. Frailty is a PRE-DISABILITY state but may increase the 'vulnerability' of many older~          people to having a fall, admission into hospital, or perhaps increasing their risk of~          hypoglycaemia~        5. As a consequence of their glucose-lowering ability, sulphonylureas may increase the~          risk of hypoglycaemia in older people and those who have features of frailty may be at~          increased risk.~        6. The investigators therefore need to estimate the risk of hypoglycaemia in moderately~          frail older subjects with type 2 diabetes who are taking sulphonylurea therapy as this~          is a commonly prescribed class of agent used routinely in clinical practice~        7. Thus, this short term project wishes to assess the frequency of hypoglycaemia in~          subjects with some evidence of frailty with type 2 diabetes by a series of glucose~          monitoring techniques with excellent research team support to minimize any safety~          issues. An identical study at the Second University of Naples, Italy under the~          supervision of Professor Giuseppe Paolisso is planned and is the second study site for~          this PILOT project.~   "
43762|NCT02484196|"~     Endometriosis is a disease that affects different areas of individual functioning, including~     the area of sexual life. Women with endometriosis have an impairment of desire and sexual~     arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the~     study is to evaluate the effectiveness of surgery on dyspareunia in women with~     endometriosis, taking into account other variables involved in determining dyspareunia: the~     quality of the couple relationship, anxiety and depression, body image, coping strategies~     and resilience.~   "
43796|NCT02483741|"~     Since there is an evidence that Manuka honey is an antibacterial agent, the present study~     aims to confirm this characteristic and assess its effect in improving healing and reducing~     postsurgical symptoms, if topically applied after the surgical removal of impacted~     mandibular third molars~   "
43763|NCT02484183|"~     Pneumonia mortality rates in African countries like Malawi are high and increased further in~     children -exposed or infected with human immunodeficiency virus (HIV) as well as those that~     are severely malnourished or severely hypoxemic. Treatment innovations are needed. Bubble~     continuous positive airway pressure (bCPAP) improves oxygenation and ventilation and is a~     simple, relatively inexpensive adaptation of conventional continuous positive airway~     pressure potentially suitable for low-resource settings. bCPAP has been demonstrated to~     improve outcomes in neonates less than 1 month of age. Recently, a limited number of~     hospitals are using bCPAP to escalate pneumonia care for older African children failing~     standard treatment with antibiotics and oxygen. Supportive evidence for this approach is~     observational only. Quality randomized studies comparing bCPAP versus a standard-of-care~     control group that includes low-flow oxygen therapy and using a primary endpoint of~     mortality are not available in low-resource settings including high prevalence HIV countries~     like Malawi. Demonstrating a mortality benefit with bCPAP is needed to support further~     investment and scale up of bCPAP in the care of older Malawian children 1-59 months of age~     with World Health Organization (WHO) severe pneumonia complicated by HIV and/or malnutrition~     or severe hypoxemia.~      With the full support of the Malawi Ministry of Health and in collaboration with external~     experts from Lilongwe Medical Relief Trust and Cincinnati Children's Hospital Medical Center~     investigators plan to address this critical evidence gap by conducting a randomized~     controlled study determining bCPAP outcomes, compared to the currently recommended standard~     of care endorsed by the WHO and Malawi national pneumonia guidelines, in hospitalized~     Malawian children with WHO-defined severe pneumonia complicated by a co-morbidity ((1)~     HIV-infection, (2) HIV-exposure without infection, (3) severely malnourished) or WHO~     pneumonia with severe hypoxemia and without a co-morbidity. The investigators hypothesize~     that bCPAP will reduce the mortality of Malawian children with WHO-defined severe pneumonia.~   "
43764|NCT02484170|"~     30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1)~     (Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of~     post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares~     PHN pain one week before, for one week on the randomly assigned mannitol versus placebo~     cream and, after a three day washout, for one week on the other cream. Following this~     crossover study, participants receive mannitol cream for three months, and ,on request, for~     a further 9 months. Pain levels will be checked to assess whether continued use of this~     cream significantly reduces the pain levels associated with PHN.~   "
43765|NCT02484157|"~     This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).~   "
43766|NCT02484144|"~     French study, multicentrique with the cooperation of several hospital centers . 700 patients~     (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a~     anonymous way.~   "
43767|NCT02484131|"~     The purpose of this study is to test the feasibility of the study protocol. The study~     protocol was designed to evaluate questions - Do educational materials improve dual x-ray~     absorptiometry (DXA) screening rates for women diagnosed with breast cancer and Does~     educational materials delivered by the participant's selected choice change DXA screening~     rates compared to the conventional mail method?.~   "
43768|NCT02484118|"~     The study purpose is to determine whether two different hemodialysis blood flow rates each~     meet national dialysis standards for urea clearance. Urea is used as the primary marker of~     dialysis adequacy. It is an experimental study with a crossover design of minimum 38~     participants. Participants will be selected from the accessible pool of end-stage renal~     disease clients at the Vancouver Community Dialysis Unit. The participants will dialyse at~     each pre-determined blood flow rate (320 mL/min and 380 mL/min) for two weeks each. Two~     forms of urea clearance data will be collected: one value that is routinely calculated by~     the dialysis machine and recorded on client treatment logs, and another that is calculated~     in a lab from blood samples.~   "
43769|NCT02484105|"~     Does comforting conversation during colonoscopy improve on patient satisfaction, compliance~     and pain management.~   "
43770|NCT02484092|"~     A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with~     Hemophilia B.~   "
43771|NCT02484079|"~     This study aims to investigate the comparative effectiveness between polyp removal with or~     without electrical current. The investigators want to include 800 polyps in the trial.~      It is known that polyps have the potential to develop to cancer if left in situ, but the~     investigators do not know the best way to remove them completely.~   "
43772|NCT02484066|"~     The purpose of this study is to evaluate the feasibility, efficacy and safety of~     transbronchial biopsy (TBB) and bronchial brushing by using virtual bronchoscopic navigation~     (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the~     diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.~   "
43773|NCT02484053|"~     Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a~     cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that~     can occur after a stem cell or bone marrow transplant), diseases of the immune system (the~     cells and substances that protect the body from infection) and rheumatologic conditions.~     Rituximab works by decreasing or temporarily eliminating a specific type of white blood~     cell, the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an~     infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or~     swelling, is very low, but highest during a patient's first infusion of rituximab and~     decreases with each additional dose. Adults commonly receive rituximab at a faster rate if~     they have done well with the first infusion, this study will help determine if the same~     approach is well tolerated in children.~      In this study, the investigators are testing a new method of administering rituximab which~     may reduce the time it takes to receive the medication. The initial ordered amount of~     rituximab will not change from the current standard of care (meaning what is usually done by~     doctors, and would likely be done if you were not on this study). The period of time over~     which rituximab is given is what is being studied.~   "
43774|NCT02484040|"~     The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral~     capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and~     leucovorin) in this randomized trial.~   "
43797|NCT02483728|"~     The purpose of this study is to evaluate if metal patch testing in metal allergic patients~     is useful for predicting the development of allergic skin disease or systemic symptoms in~     patients who recieve a metal orthopedic implant.~   "
43798|NCT02483715|"~     Up to now, there is few randomized, large scale study prospectively and simultaneously~     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy~     (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori~     eradication.~      The aims of this study are:~        1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
43775|NCT02484027|"~     This study is randomized, open-lable, parallel-group and comparator-controlled. 456~     consecutive patients with acute ischemic stroke admitted within the first 72 hours after~     onset of symptoms will be studied. Those patients who will be randomly assigned to receive 2~     different treatment for the first 3 days of hospitalization(non-statin-therapy group) or to~     immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From~     the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients. The~     total trial will be continued 12 months.~      mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be~     investigated at baseline and 12th month. Laboratory data including serum lipids, Fg and~     hs-CRP.Among these, serum lipids will be tested at baseline, 8th day, 3rd month, 6th~     month,and 12th month; hs-CRP will be tested at baseline and 8th day, 3rd month; Fg will be~     tested at baseline, 8th day, 3rd month. Safety will be also assessed by adverse event~     reports and clinical laboratory data including CK-MB, renal and hepatic function at 3rd~     month, 6th month,12th month.~   "
43776|NCT02484014|"~     SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent~     health, seeks to develop and evaluate a school based adolescent health promotion~     intervention delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM)~     and lay school counsellor called as SEHER Mitra (SM) in government-run secondary schools in~     Bihar, India. SEHER will implement a three armed clustered randomised trial (CRT) to~     evaluate the effectiveness and cost-effectiveness of these two models compared with the~     Tarang-Adolescence Education Programme (usual care) implemented by the State Government of~     Bihar. The hypothesis is that both interventions, compared to the control arm, will lead to~     a greater impact on school climate (school connectedness and relationship with teachers and~     fellow students). In addition, the interventions will increase the knowledge, attitude and~     awareness, and promoting healthy behaviours in youth on reproductive and sexual health~     outcomes, mental health and substance use, and gender related attitudes and violence. It is~     hypothesized that the addition of more resource intensive component (the SM arm) will be~     associated with the best outcomes.~   "
43777|NCT02484001|"~     This is a Phase III, multinational, open-label, non-controlled study with subjects under~     treatment in the double-blind BIA-2093-311 study (NCT01162460).~      Subjects will enter the open-label extension study after the preceding double-blind study~     was unblinded and they are attending their last Extension Phase Visit (EPV) of the~     double-blind study.~      For all subjects, the day of the last EPV of the double-blind study will also be the day of~     Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine~     acetate (ESL) under open-label conditions at Visit 1.~      The complete study duration including treatment with ESL under open-label conditions and~     follow-up is expected to last approximately 2 years (105 weeks).~      In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be~     discontinued prematurely within 42 days after achievement of MA.~   "
43778|NCT02483975|"~     Inhaled corticosteroids (ICS) have a number of known class effects including~     hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled~     Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has~     been established, it is important to assess the risk of suppression in children so as to~     establish whether this medicine can be safely used in this young population. This study aims~     to evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age~     (inclusive) with persistent asthma compared with placebo. Approximately 143 subjects will be~     enrolled. Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams~     (mg) (5 year old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects~     will be randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or~     once-daily placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days.~     Subjects will continue to receive open label montelukast during the treatment period. All~     subjects will be provided albuterol/salbutamol inhalation aerosol, to use as needed to treat~     acute asthma symptoms throughout the study.~      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.~   "
43779|NCT02483962|"~     Chronic Venous Insufficiency (CVI) occurs when the veins in the lower limbs can no longer~     sufficiently pump enough blood back to the heart. Symptoms may include: dull aching,~     cramping, itching or tingling in the calves, swelling, redness or any colour changes as well~     as thickening of the skin in the lower limbs. The most common indication of CVI is dilated~     veins known as varicose veins. CVI is a disorder found more commonly in females.~     Conventional treatments for CVI include vein ligation or stripping, elastic compression,~     valve reconstruction and sclerotherapy venous bypass. Amongst other treatment, exercise has~     also proven to be effective in improving CVI as it increases circulation, by increasing~     blood returning to the heart. A variety of herbal supplements have been proven to be safe~     and effective in the treatment of CVI. Red vine leaf extract has also been proven to be~     useful in the treatment of CVI. Previous studies on the red vine leaf extract have shown~     that it is an effective and safe treatment of CVI. Studies done on horse chestnut extract~     have stated that the extract increases venous tone and decreases capillary permeability.~     Butcher's broom extract has been proven to be effective in the treatment of CVI. There are~     currently no studies done on the combination of red vine leaf extract, butcher's broom~     extract, horse chestnut extract and vitamin B6.~      The aim of this study is to determine the efficacy of a combination of red vine leaf extract~     (360mg), horse chestnut extract (60mg), butcher's broom extract (35mg) and pyridoxine~     (vitamin B6) (3.2mg) in the treatment of symptoms associated with CVI, using a Venous~     Clinical Severity Score questionnaire (VCSS) .~   "
43780|NCT02483949|"~     To examine the effectiveness of a group-based lifestyle modification program followed by~     peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk~     reduction. The lifestyle modification program will support daily ambulatory activity and low~     glycemic index food intake among women with previous gestational diabetes mellitus (GDM).~   "
43781|NCT02483936|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
43782|NCT02483923|"~     Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and~     consumption of opioid after mastectomy.~   "
43783|NCT02483910|"~     The purpose of this study is to test whether Direct Instruction - Language for Learning~     (DI-LL) is an effective way to teach language skills to children with autism spectrum~     disorder (ASD) and moderate language delay.~   "
43784|NCT02483897|"~     Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing~     phase. Current practice guidelines discourage the use of topical anesthetics in treating~     these patients due to concerns that these medications may prevent proper corneal epithelial~     healing. These concerns are based primarily on decades old animal based research. However,~     recent evidence suggests topical anaesthetics are a safe and effective way of managing~     patient pain in the short term. This study will investigate the effect of topical 0.5%~     tetracaine on corneal healing and pain management in patients with corneal abrasions in the~     first 48 hours.~      This will be a prospective, double blind, randomized, controlled study of 260 adults with~     uncomplicated acute corneal injuries presenting to the tertiary acute care settings in~     Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in~     addition to usual care as outpatients. They will be followed through the ophthalmology~     emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary~     outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm~     Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing,~     use of adjunct pain medications, time lost from work/usual activities, quality of sleep,~     ability to read and the SF12 quality of life questionnaire.~      This study will better inform the safety and effectiveness of short-term tetracaine usage in~     patients with simple corneal abrasions for optimal treatment of patients in the future.~   "
43785|NCT02483884|"~     The aim of this study is to investigate safety and diagnostic performance of the 68Ga~     labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer~     confirmed by histopathology of the prostate as a standard of truth.~      This is an open-label, multi center PET/CT (positron emission tomography/computed~     tomography) non-randomized study. The study comprises 2 parts with an interim analysis after~     Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be~     enrolled. Three strata of patients for the first part will be enrolled based on their~     pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with~     low, 10 patients with intermediate and 10 patients with high pretreatment risk of~     recurrence.~   "
43786|NCT02483871|"~     Patients will be treated in a dose escalation scheme to investigate a role for the addition~     of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take~     oral rosuvastatin daily. The maximum number of patients evaluable for a DLT is 12. Dosing~     will be as follows: Cohort 1 - rosuvastatin 20mg, Cohort 2 - rosuvastatin 40mg. The patients~     will have a total of 4 blood draws and 4 breast biopsies. The breast biopsies will be~     collected to evaluate cholesterol metabolites and tumor microenvironment characteristics~     including gene expression profiling and metabolomics. Sampling will occur at study entry,~     week 4, week 8, and at the time of surgery in early stage patients or at week 16 for~     metastatic patients. Patients will begin endocrine therapy following the acquisition of week~     4 samples (blood and tissue biopsy).~   "
43787|NCT02483858|"~     This is a nonrandomized, dose escalation Phase I study designed to evaluate the safety and~     tolerability of PQR309 in the treatment of selected patients with advanced solid tumors with~     known activation of AKT/PI3K/mTOR.~   "
43788|NCT02483845|"~     Muscle biopsies of patients with Inclusion Body Myositis (IBM) have demonstrated a T-cell~     predominant inflammatory infiltrate, therefore, new agents targeting T -cell mediated cell~     death may be a novel treatment for IBM. Such an agent capable of preventing T-cell movement~     out of the vasculature, such as natalizumab, may be beneficial in IBM patients. Six patients~     will be recruited to participate in this phase I trial.~   "
43789|NCT02483832|"~     The main purpose of this study is to promote colorectal cancer (CRC) screening among~     individuals who have never been screened, with these individuals being members of a panel~     who participant in online studies. The primary study goals are to test effects of the~     matching between level of comparative risk feedback for colorectal cancer (CDC), that is,~     how one's risk compares to others, and message framing (Gain vs. loss frame) on CRC~     screening intentions and screening as well as mediators of effects in the context of people~     who obtain CRC risk feedback and framing messages online (i.e., Internet).~   "
43790|NCT02483819|"~     The purpose of this study is to evaluate the change of the hemodynamic profiles on bio~     reactance technique during TURP in elderly patients.~   "
43791|NCT02483806|"~     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary~     shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by~     transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia~     during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying~     PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can~     mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are~     controversial studies whether it is supportive or not. In this prospective, cross-over~     study, the investigators are planning to investigate the effects of PEEP on intrapulmonary~     shunt, oxygenation and cardiac function as well.~   "
43792|NCT02483793|"~     The primary objective of this study is to evaluate the efficacy and safety tamsulosin in~     reducing stent discomfort in the pediatric population in the peri-operative period. The~     secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in~     reducing stent discomfort.~   "
43793|NCT02483780|"~     The proposed pilot community-based research project will examine the feasibility,~     acceptability, and potential efficacy of the Storytelling intervention compared with usual~     care in hypertension control among rural residents in 4 communities in Vietnam. This is a~     major clinical and public health problem in this developing country.~   "
43794|NCT02483767|"~     The study is a prospective randomized control clinical trial which is sponsored by the~     researchers. The purpose of this study is to determine the effectiveness of~     Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer~     patients during chemotherapy. The premenopausal breast cancer patients will be randomly~     (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin~     group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients~     are stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or~     ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and~     cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years.~     The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone,~     pregnancy outcomes and disease-free and overall survival will be compared between two groups~     to evaluate the effectiveness of protect against ovarian failure.~   "
43799|NCT02483702|"~     Blood transfusions are required for patients undergoing a craniosynostosis repair due to the~     significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks~     involved including elevated potassium levels and graft versus host disease (TA-GVHD).~     Irradiated blood is able to destroy the leukocytes responsible for TA-GVHD, but it adversely~     causes elevated extracellular potassium due to hemolysis of the RBC's. When this blood is~     transfused, it may introduce too much extracellular potassium (> 6.5 meq/L) into the patient~     causing interference with the heart's conduction system significantly increasing the risk~     for hemodynamic changes, cardiac arrhythmias, and cardiac arrest. Hyperkalemia from rapid~     transfusions occurs much more frequently than TA-GVHD; however, both complications are~     under-reported.~      The study aims to evaluate the risk of irradiated versus non-irradiated blood in patients~     under the age of 6 months undergoing a craniosynostosis repair. This will be done by~     comparing the levels of extracellular potassium pre-transfusion, during transfusion,~     immediately after transfusion, and 30 minutes after the completion of transfusion. The~     investigators hypothesize that the patients who receive irradiated blood will have an~     increased extracellular potassium level compared to those who receive non-irradiated blood.~   "
43800|NCT02483689|"~     Patient will have usual appendectomy surgery with an injection of local or saline at~     incision site either before or after the incision at random.~      The clinical hypothesis of this trial is that pediatric patients who undergo a local~     anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative~     pain and therefore reduce the amount of analgesics required to keep the patient satisfied.~      Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess~     the timing of local anesthetic injection affects postoperative pain.~   "
43801|NCT02483676|"~     Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient,~     aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented~     adaptive control system, this study tests whether robotic assisted treadmill training will~     improve gait and balance functions in chronic stroke survivors with foot drop impairment. It~     is hypothesized that, compared to treadmill training alone, integrating adaptive ankle~     robotics with treadmill training will reduce drop foot during independent overground~     walking, resulting in greater mobility, improved postural control and reduced fall risk.~   "
43802|NCT02483663|"~     Scientists are examining the genetic and environmental influences on appetite and weight~     gain. The main purpose of this study is to look at how genetic and environmental factors may~     influence how the brain regulates appetite and food intake. Understanding how the brain~     regulates appetite and food intake may eventually lead to new ways to help people avoid~     obesity or lose weight.~   "
43803|NCT02483650|"~     The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world~     patient outcome and side effect information from electronic health records submitted to a~     specialty specific hyperbaric registry as part of Stage 2 of Meaningful Use, including~     data provided to meet PQRS requirements via the registry's QCDR mission.~      Goals include understanding the value of HBOT among patients treated for a variety of~     conditions in relation to the frequency and severity of HBOT side effects. While randomized,~     controlled trials can establish the efficacy of treatments like HBOT, because they routinely~     exclude patients with co-morbid conditions common to those patients seen in usual clinical~     practice, the results of RCTs are usually non-generalizable. Real world data can be used to~     better understand the effectiveness of HBOT among typical patients, as well as the risks~     associated with treatment.~   "
43804|NCT02483637|"~     This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic~     bronchitis patients with airflow restrictions.~   "
43805|NCT02483624|"~     This is a single center study of patients with inactive or mild SLE being performed to~     determine the safety, tolerability, and pharmacodynamics of DIM.~   "
43806|NCT02483611|"~     The magnesium sulfate and lidocaine have been increasingly used alone or in combination~     during anesthesia procedure to meet various objectives, such as reduction of pain, use of~     smaller anesthetic doses and stabilization of hemodynamic parameters.~      These medicines are often used in combination with neuromuscular blocking agents, which may~     contribute to the occurrence of residual block in some patients after anesthetic procedures.~     It was estimated that only 1-3 % of patients with residual block developing clinically~     apparent events. In a small proportion of patients, the consequences of residual blockade~     are very serious and even lethal. It is estimated that 40 % of patients with muscle~     paralysis come to the post-anesthesia care unit (PACU).~      Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of~     applications in various areas of medicine, (b) these medications stand out for their~     properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of~     reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been~     important part of the therapeutic arsenal to control a large number of diseases (d) the~     patient surgical surgery or potentially have benefited in particular from its effects, (and)~     these drugs have been used routinely in many medical services as well as adjuvants in~     anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the~     duration of neuromuscular blockade by different types of muscle relaxants, with~     controversies about its effect on latency (g) the effect of lidocaine on the action of~     muscle relaxants in current literature have shown great controversy and (h) do not exist in~     the literature studies involving both drugs; the investigators aimed to investigate the~     effects of magnesium sulphate infused alone or associated with lidocaine on the~     neuromuscular blockade promoted by cisatracurium, as well as evaluate its possible~     hemodynamic repercussions. For this purpose the SM was infused in bolus, prior to tracheal~     intubation and continuously during the maintenance of general anesthesia; the Lidocaine,~     when associated and the Isotonic Solution were used in the same way and timeline as SM. As~     secondary objectives it has been proposed to evaluate if the Lidocaine with Magnesium~     Sulfate would be able to interfere with the hemodynamic stability of the patients in the~     study.~   "
43807|NCT02483598|"~     This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post~     weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had~     a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass~     group. For this purpose, we will compare post-bariatric surgery patients with control~     subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when~     administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.~   "
43808|NCT02483585|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled Study followed by open-label~     treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from~     baseline in monthly migraine days, in subjects with episodic migraine~   "
43829|NCT02483312|"~     This is a phase 1 study (the first stage in testing a new treatment to see how safe and~     tolerable the treatment is) which will include patients with acute myeloid leukemia (AML)~     that has either returned or has a more than a 70% chance of coming back and cannot have a~     bone marrow transplant.~      This study will see whether modifying a patient's AML cells to produce IL-12 and giving it~     back to the patient is safe and useful in patients with AML that cannot have bone marrow~     transplants.~   "
43809|NCT02483572|"~     Children with an intellectual disability often display severe destructive behavior (e.g.,~     aggression, self-injury) that pose risks to themselves or others and represent barriers to~     community integration. Destructive behaviors are often treated with behavioral interventions~     derived from a functional analysis, which is used to identify the antecedents and~     consequences that occasion and reinforce the destructive behavior. One treatment is called~     functional communication training (FCT), which involves extinction of destructive behavior~     and reinforcement of an alternative communication response with the consequence that~     previously reinforced destructive behavior. Results from epidemiological studies and~     meta-analyses indicate that treatments based on functional analysis, like FCT, typically~     reduce destructive behavior by 90% or more and are more effective than other treatments.~     However, many if not all of these studies have used within-subject experimental designs to~     demonstrate control of the treatment effects. Replication of the effects of FCT is typically~     shown on a subject-by-subject basis with relatively small numbers of patients (e.g., one to~     four patients). No study has demonstrated the effectiveness of FCT for treatment of~     destructive behavior across a large group of children.~      The goal of this study is to compare FCT (which is used clinically with the majority of the~     investigators' patients and is considered best practice for treating destructive behavior~     that occurs for social reasons [e.g., to access attention, preferred toys, or to escape from~     unpleasant activities]) to a waitlist control group across a large number of children with~     destructive behavior to evaluate the generality of FCT effectiveness. The investigators will~     evaluate rates of destructive behavior with each patient during a pretest baseline and again~     following FCT (approximately four months later) and/or the waitlist control duration (again,~     approximately four months later). All children assigned to the waitlist-control condition~     will be offered FCT services by the investigators' clinic at the end of the four-month~     waitlist period. These children will again be tested following four months of FCT (i.e.,~     posttest). Therefore, children assigned to the FCT condition will be tested twice (one~     pretest and one posttest), and children assigned to the waitlist-control condition will be~     tested thrice (one pretest, a second pretest following a four-month waitlist period, and one~     posttest).~   "
43810|NCT02483559|"~     The purpose of the study is to test the use of amber glasses at night as a method to block~     blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The~     investigators hypothesize that blue-blocking will produce measurable benefits in~     subjectively and objectively rated sleep quality and mood as well as salivary melatonin~     levels during the night.~   "
43811|NCT02483546|"~     High fidelity Simulation has spread from anesthesiology to other disciplines such as~     internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of~     simulation in medical education has increased exponentially. The term ''simulation'' spans a~     wide variety of formats, from the low-tech actor portraying a standardized patient to~     high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating~     realistic patient encounters and giving real-time, physiologically accurate feedback.~     Studies thus far show that use of simulation in training medical students and residents is~     helpful in strengthening students' knowledge and in evaluating their performance. Students~     appreciate simulation-based education as ''an opportunity to learn new skills in a safe~     environment .~   "
43812|NCT02483533|"~     LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of~     clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 or~     LIPO-202-CL-19 (parent studies). No risks related to treatment are anticipated as subjects~     will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this~     follow-on study.~   "
43813|NCT02483520|"~     This clinical trial will test the FamTechCare intervention that uses multidisciplinary~     professional guidance based on in-home video monitoring to support family caregivers in~     managing challenging behaviors of persons with dementia (PWD). Families provide the majority~     of care for PWD at home. However the stress of caregiving is so significant that it~     increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in~     PWD that frequently lead to nursing home placement. In-home video monitoring allows experts~     to assess behaviors of PWD and to identify antecedents, recommend specific interventions.~     FamTechCare uses new technology to link family caregivers to experts for guidance in~     managing disruptive behaviors, supporting continued care at home while reducing the negative~     effects of caregiving.~      Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both~     groups will record behaviors during daily care for 3 months using a home monitoring unit.~     Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording~     behavior triggers and precursors. Caregivers record care situations they select and upload~     videos to a secure site. The expert team will review intervention group videos weekly and~     will provide individualized feedback for improving care to caregivers in the home. The~     control group caregivers will receive a weekly phone call and advice from a nurse, but their~     recorded videos will be held for review and individualized feedback provided after 3 months.~      Study aims are to use observation to assist caregivers in behavior management. Effects on~     disruptive behaviors and caregiver burden and other negative outcomes will be compared.~     Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors~     influencing likelihood of translation into practice. This is the first study to test new~     technology for direct observation and immediate feedback to empower families to manage PWD~     behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers~     to individualized expert guidance, acknowledging the importance and burden of their role.~     This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease~     goals, integrating strategies to promote adoption and use of aging services technologies in~     interventions that will reduce negative caregiver outcomes, a growing public health problem.~   "
43814|NCT02483507|"~     Landmarks used to make a vascular puncture has long been based on the only knowledge of~     anatomy. This method assumes that the target vessel is in its expected position, permeable~     (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions~     is likely to cause failures of puncture and complications. The development of ultrasound~     allowed to see the structures to achieve, whether before a puncture or in live for guiding~     the procedure. Visualization of vessels and adjacent structures has logically resulted in~     larger cases to a greater security of catheterization, improving the success rate, and~     decreasing complications. Several positions of the probe can be used to guide a puncture~     under ultrasound: the transversal approach in short axis, the long axis longitudinal~     approach and the oblique view approach.The aim of the study was to compare these three~     different ultrasound-guided approaches to peripheral vascular access in children. All~     children weighing less than 30 kg that should benefit from the introduction of an arterial~     catheter or central venous catheter introduced through a peripheral vein are eligible.~     Patients will be included after parent's and children's information and consent. The choice~     of the technique used (transverse, longitudinal or oblique approach) is determined by a~     randomization table.The puncture procedure is performed according to the usual protocols of~     the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile~     manner. No time limit is required for the identification and implementation of the catheter.~     The position of the probe is dictated by the result of randomization and the Seldinger~     technique is used for the establishment of the catheter. Beyond two unsuccessful attempts,~     the procedure is considered as a failure. The anesthetist then uses the alternative~     technique of his choice. All anesthetists participating in this study exercised their main~     activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of~     ultrasound-guided peripherally inserted central catheter and arterial catheter is part of~     the current activity of the unit.~   "
43815|NCT02483494|"~     Aim. To develop and examine the effectiveness of an APN-led telehealth rehabilitative~     programme as a transitional nursing therapeutic on readmission rates and health related~     outcomes amongst patients with Acute Myocardial Infarction (AMI) post discharge.~      Design. Randomized controlled trial with repeated measures.~      Methodology. A consecutive sampling of 172 patients with AMI will be recruited from a~     tertiary hospital in Singapore. Participants will be randomised into two groups. The~     experimental group (ALTRA) will receive APN-led telehealth rehabilitative programme upon~     discharge in addition to standard care. The control group will receive only standard~     follow-up care.~   "
43830|NCT02483299|"~     The purpose of this study was to determine whether combined treatment with liraglutide and~     metformin is more effective than metformin as monotherapy in the treatment of obese women~     with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in~     patients on combined treatment than in those on monotherapy.~   "
44417|NCT02475655|"~     The purpose of this study is to evaluate the safety and tolerability of ruxolitinib in~     HIV-infected adults who are virologically suppressed and who are on antiretroviral therapy~     (ART).~   "
43816|NCT02483481|"~     Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive~     disease-affecting children following bone marrow transplantation (BMT). SOS most likely~     develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease~     can be separated into mild, moderate, and severe forms; almost all patients diagnosed with~     severe SOS will die from this disease. Children with severe SOS suffer from multi-organ~     failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and~     respiratory failure . Although these children may be few and far between, the mere severity~     of the disease process and awful prognosis factors are valid reasons for more medical~     attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis~     and treatment, children continue to die from this devastating disease.~      Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an~     emerging technology that uses ultrasound pressure waves to provide an estimate of tissue~     stiffness. This technique is promising for pediatric imaging because it is portable, quick~     to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation~     imaging and ultrasound elastography does not have any increased risks over conventional~     ultrasound imaging.~   "
43817|NCT02483468|"~     The primary objective of this study is to evaluate the effects of cognitive-behavioral~     therapy in combination with transcranial direct current stimulation in (1) improving pain~     and functionality, (2) reducing severity of opioid use disorders, and (3) reducing~     impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The~     investigators will also determine the effects of treatment on neural activity in cognitive~     and limbic brain regions involved in pain regulation using functional magnetic resonance~     imaging (fMRI), and examine its relationship to opioid use severity.~   "
43818|NCT02483455|"~     This is a single-center, randomized, double blind, vehicle-controlled phase 2 study of~     subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.~   "
43819|NCT02483442|"~     Prospective, multicentre, cohort study assessing a diagnostic management strategy for~     suspected Pulmonary Embolism with independent central adjudication of outcomes~   "
43820|NCT02483429|"~     AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to~     standard care to assess accuracy of diagnoses and initial management decisions for emergency~     department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of~     vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will~     accurately, safely, and efficiently differentiate peripheral from central vestibular~     disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the~     potential to improve post-treatment clinical outcomes for these patients.~   "
43821|NCT02483416|"~     The study will take place over a period of 27 months. The recruitment phase will last~     approximately 24 months and each patient will participate for approximately 3 months.~      At the inclusion visit (D0), the investigator will ask the patient whether he would like to~     participate in the study and will obtain his written consent.~      Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the~     following 2 groups:~      Group without `remote additional personalised nurse-led follow-up: patients will receive the~     healthcare given routinely by their medical team (100 patients).~      Group with `remote additional personalised nurse-led follow-up: patients will receive~     telephone calls from a nurse in addition to the healthcare given routinely by their medical~     team (300 patients).~      All the patients will be seen according to normal practice by the study medical team.~      Patients in the group with `remote additional personalised nurse-led follow-up will be~     contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse~     will make sure that the treatment takes place in good conditions; she cannot intervene in~     the medical care of the patient, nor give answer to the questions relative to the disease or~     to the treatment of the patient. The medical team remains the privileged contact of the~     patient.~   "
43822|NCT02483403|"~     Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and~     exercise testing for the development of tools to quantify and validate longitudinal in vivo~     magnetic resonance imaging phenotypes of the aging lung.~   "
43823|NCT02483390|"~     The increasing awareness of the importance of palliative care has led, in Israel, to the~     2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility~     to palliative care remain unresolved. The use of e-health services is likely to expand the~     ability of the medical, psychosocial and nursing staff to reach patients who are either~     living in the periphery, are unable to make clinic visits or whose family members are~     housebound in order to be caregivers. This exploratory research is designed to explore the~     issues, barriers and advantages of e-health care through the perspective of the palliative~     care staff members, the patients themselves and their caregiving family members.~   "
43824|NCT02483377|"~     This research trial studies how well patient navigation and tailored treatment planning work~     in Latina patients with breast cancer. Patient navigation and tailored treatment planning~     may provide extra support by guiding patients through the healthcare system, remove barriers~     to care and provide ease of access to essential resources, encourage patient participation~     in their care, provide in-language summaries and plans for follow-up care, improve patient~     access to needed supportive care services and may improve general healthcare experience in~     Latina patients with breast cancer.~   "
43825|NCT02483364|"~     The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 in the~     surgical treatment of atrophic nonunion in long bones.~   "
43826|NCT02483351|"~     The purpose of this study is to determine the feasibility of conducting a large trial~     examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion~     strategy compared to a restrictive strategy (usual care) in patients with aneurysmal~     subarachnoid hemorrhage (SAH).~   "
43827|NCT02483338|"~     This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale)~     to assess postoperative children pain.~   "
43828|NCT02483325|"~     Determine the efficiency of a myéloablative conditioning associating Fludarabine,~     Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics~     realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in~     preparation for a allogenic transplant family or not family compatible HLA.~   "
43831|NCT02483286|"~     OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among~     community-dwelling older adults with high osteoporotic fracture risks.~      MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall,~     osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National~     Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group~     (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang~     Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All~     participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty,~     fall prevention, nutrition, and coping strategy and another hour of professional led~     exercise program. ICG subjects received once weekly group exercise while MTG subjects~     received twice weekly machine-based resistence training on major muscle groups. XBG subjects~     rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass~     (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension~     power at baseline and after 12-weeks of intervention.~   "
43832|NCT02483273|"~     Study hypothesize that ocular microcirculation is reflecting cerebral perfusion. The purpose~     of this study is to evaluate ocular microcirculation in brain dead patients using side dark~     field (SDF) videomicroscope and compare it with microcirculatory parameters of healthy~     volunteers.~   "
43833|NCT02483260|"~     To provide an intravenous ribavirin therapeutic option for patients with a probable or~     suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or~     Lassa fever.~   "
43834|NCT02483247|"~     This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination~     with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of~     the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with~     each of the selected anti-cancer agents.~   "
43835|NCT02483234|"~     Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions~     in psoriasis patients and patients with PsA. Primary Objective is the improvement of the~     PsAMRIS synovitis score baseline vs. week 24.~      Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a~     duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic~     arthritis (PsA).~   "
43836|NCT02483221|"~     Treatment of postoperative pain with hydromorphone (a strong analgesic) using~     patient-controlled analgesia with target-controlled infusion compared to conventional~     patient-controlled analgesia with morphine after elective cardiac surgery~   "
43837|NCT02483208|"~     The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after~     intravenous administration.~   "
43838|NCT02483195|"~     The investigators propose to conduct a head-to-head, randomized clinical trial to compare~     the effectiveness of Minoxidil with Spironolactone and Finasteride in treating~     postmenopausal females with Androgenetic Alopecia (AGA).~   "
43839|NCT02483182|"~     This is a phase II, prospective, randomized, double-blind, parallel group,~     acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary~     therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes~     labialis), following five consecutive treatment days with five times daily topical~     administration.~   "
43840|NCT02483169|"~     Through this study, the investigators are to prove that Cilostazol effectively prevent~     progression of intima-medial thickness in ischemic stroke patients with high risk of~     cerebral hemorrhage, along with no significant increase in the risk of occurrence of~     hemorrhagic side effects.~      The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the~     progression of intima-medial thickness compared to aspirin in the ischemic stroke patients~     with symptomatic or asymptomatic old cerebral hemorrhage.~   "
43841|NCT02483156|"~     Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study~     comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of~     EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety~     and efficacy for both arms.~      Sponsor: Wadi El Nil Hospital~      Study Centers Planned: Approximately 2 sites in Egypt~   "
43842|NCT02483143|"~     Study objective:~      The purpose of this study was to compare the role of the prophylactic protocols~     N-acetylcysteine (NAC) plus normal saline, sodium bicarbonate (NaHCO3) plus normal saline~     and intravenous normal saline (NS) alone in the prevention of contrast-induced nephropathy~     (CIN) after computed tomography pulmonary angiography (CTPA) in emergency patients with~     suspected pulmonary embolism (PE).~      Materials and methods:~      This study was planned as randomized, double blind, placebo controlled clinical research.~     Patients presenting to the emergency department within a 1-year period, undergoing CTPA on~     suspicion of PE and having one or more risk factors for development of CIN were included in~     the study. The NAC group received 1 ml/3 mgr NAC+NS solution 1 h before CTPA and 1 ml/kg per~     hour for a minimum 6 h after CTPA. The NaHCO3 group received 132 mEq NaHCO3+NS solution for~     1 h before CTPA and 1 ml/kg per hour for a minimum of 6h after CTPA. The normal saline (NS)~     group received 3 ml/kg NS for 1 h before CTPA and 1 ml/kg per hour NS for a minimum 6 h~     after CTPA. CIN was evaluated as the primary outcome, and moderate renal injury (defined as~     a 100% increase in serum creatinine levels), severe renal insufficiency requiring~     hemodialysis or peritoneal dialysis) or in-hospital mortality as secondary outcomes.~   "
43843|NCT02483130|"~     A double-blind, placebo controlled, crossover study to determine whether a single dose of~     N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients~     with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in~     brain perfusion and activity following a single dose of N-acetylcysteine.~   "
43844|NCT02483117|"~     The Clinical Impairment Assessment (CIA) assesses psychosocial impairment secondary to an~     eating disorder. The aim of this study was to create and validate a Spanish-language version~     of the CIA. Using a forward-backward translation methodology, we translated the CIA into~     Spanish and evaluated its psychometric characteristics in a clinical sample of 178 ED~     patients. Cronbach's alpha values, confirmatory factor analysis (CFA), and correlations~     between the CIA and the Eating Attitudes Test-12 and the Health-Related Quality of Life in~     ED-short form questionnaires evaluated the reliability, construct validity, and convergent~     validity, respectively. Known-groups validity was also studied comparing the CIA according~     to different groups; responsiveness was assessed by means of effect sizes.~   "
43846|NCT02483091|"~     To assess the feasibility of conducting a larger cluster randomized controlled trial to~     facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e.~     implementation of multimodal care, into chiropractic clinical practice, designed to improve~     the management of patients with Non-Specific Neck Pain (NSNP) disorders.~      To evaluate feasibility, the investigators will ascertain how well participating~     chiropractors and patients adhere to the study protocol and will solicit feedback from them~     about the overall usefulness of the content and format of the KT intervention. This study~     will determine planning for the main study and also the outcomes to be used as a primary~     outcome.~   "
43847|NCT02483078|"~     This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy,~     safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for~     one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population~     includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates~     evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented~     genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or~     more drug classes with limited treatment options).The options may be limited as a result of~     drug antiviral class cross-resistance or documented treatment intolerance.~   "
43848|NCT02483065|"~     People with dementia have complex medical, social, and psychological needs and can be~     exacerbated by physical illness and the complex relationships between health care systems,~     patients and their families or caregivers. They are a vulnerable and fragile population that~     differs significantly from the population without dementia. Therefore, the investigators~     propose the following objectives: 1. To describe the evolution of dementia patients admitted~     during the study period in two hospitals in the Basque Health Service-Osakidetza and~     complications associated with such admissions. 2. To compare with a control group (matched~     by type of pathology, age and sex and adjusting for other clinical variables (severity of~     dementia ...) the patient's condition before and after admission, in terms of quality of~     life, dependency, instrumental activities of daily living and severity of dementia. 3. To~     compare the length of stay, complications, mortality rate, the degree of dependency and~     quality of life of patients with dementia compared to those without dementia, matched by~     groups of pathologies, gender and age.~   "
43849|NCT02483052|"~     RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days~     prior to prescheduled lung resection in Subjects requiring lobectomy for removal of~     peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that~     will be removed, distal to the anticipated margin of resection. Treatment should be at least~     1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will~     be inspected via bronchoscopy at the time of thoracotomy, and examined histologically~     following surgical resection. Subject participation will be from 1 to 90 days and enrollment~     is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a~     resection for any reason will be followed for a maximum of 90 days for safety and undergo~     bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.~   "
43850|NCT02483039|"~     The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse~     kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who~     are not exposed to the AKI Follow-up Clinic intervention.~   "
43851|NCT02483026|"~     This study will examine the effect of providing a structured program of daily nutritional~     supplements for a 6 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on~     bone mass density status and formation of critical nutritional deficiencies years after the~     surgery.~   "
43852|NCT02483013|"~     Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and~     tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for~     four weeks. Sixty participants were selected in accordance with inclusion and exclusion~     criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2-~     Close up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the~     instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual~     oral hygiene, three times per day during four weeks. Evaluators assessed tooth color~     (CIEL*a*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3~     and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).~   "
43853|NCT02483000|"~     This phase I/II trial studies the side effects and best dose of anti-cluster of~     differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given~     before chemotherapy and stem cell transplant in treating patients with B-cell malignancies~     that have not responded to treatment or have come back after responding to treatment. CD20~     is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT~     attaches radioactive material to a drug that is designed to target CD20, which brings~     radioactive material to the cancer cells to kill the cells. This may kill more tumor cells~     while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard~     chemotherapy and stem cell transplant may be more effective in treating patients with B-cell~     malignancies.~   "
43854|NCT02482987|"~     The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and~     BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket~     preservation procedures, both when the socket is filled and overfilled with freeze dried~     bone allograft (FDBA).~   "
43855|NCT02482974|"~     This study aims to determine the safety and efficacy of conversion of sirolimus to~     everolimus in the maintenance treatment of LT recipients. Patients will be monitored every~     12 weeks after the switch of treatment for 48 weeks. The laboratory tests including~     hematological, renal, hepatic, and metabolic parameters will be performed at each visit.~     Twenty-four-hour urine creatinine clearance and proteinuria will be determined from a~     24-hour urine collection at baseline and week 48.~   "
43856|NCT02482961|"~     This study purposed to examine the adequate range of therapeutic concentration for Korean~     people by observing curative effects, side effects, blood concentration, etc. in treating~     CRAB-infected patients with colistin.~   "
43857|NCT02482948|"~     The purpose of this study is to compare how well two products, Active Leptospermum Honey~     (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living)~     tissue.~   "
46090|NCT02453711|"~     This trial is conducted globally. The aim of this trial is to investigate safety and~     efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.~   "
43858|NCT02482935|"~     The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood~     stream and how long the body takes to get rid of it when given with and without food. In~     addition, the safety and tolerability of the study drug will be evaluated. Information about~     any side effects that may occur will also be collected. The study will last about 43 days~     for each participant, not including screening.~   "
43859|NCT02482922|"~     Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise~     training (IET) and nutrition program, as well as its preliminary effects on resting heart~     rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among~     primary care patients who have at least one risk factor for cardiovascular disease (CVD).~      Participants : 30 patients who receive care from the University of North Carolina (UNC)~     Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC~     patients, not diagnosed with severe illness), will be enrolled to test the feasibility of~     the home-based interval exercise and nutrition program.~      Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In~     Phase I, 15 patients will be enrolled into the program, which will take approximately 3~     months. At baseline, data will be collected on age, height, weight, resting heart rate,~     blood pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin,~     percent body fat, cardiovascular fitness, and use a series of questionnaires to evaluate~     mood, sleep, hunger, and quality of life. At closeout, the investigators will measure~     patients' adherence to each component of the intervention. In Phase II, an additional 15 new~     patients will be enrolled in either the identical protocol, or a slightly modified~     intervention (if necessary based upon our results from Phase I). All patients will have the~     same variables measured at baseline during their study visit at 3, 6 and 12 months after~     enrollment into the study.~   "
43860|NCT02482909|"~     The purpose of this prospective randomized study is to compare the efficacy and safety of~     radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very~     homogeneous underlying conditions.~   "
43861|NCT02482896|"~     The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in~     Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent~     than in the urban areas of the country. The population study aims at examining complexities~     of environmental, hereditary, lifestyle, and social factors as determinants and predisposing~     factors for morbidity, health, and quality of life. The study will cover physical, mental,~     and social dimensions and examine family patterns and subgroups. The study will provide~     baseline information for later follow-up.~   "
43862|NCT02482883|"~     Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all~     cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological~     sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly~     related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is~     generally secondary to cerebral vasospasm.~      Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is~     associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following~     SAH in these patients.~      Despite a significant improvement in the time to management of this disease and the fact~     that the ruptured aneurysm is very often rapidly excluded by surgical or endovascular~     intervention, patients who survive the initial SAH remain at risk of severe complications~     over the following 2 weeks.~      Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more~     than 70 to 95% of cases on digital subtraction angiography between the 7th and 14th days~     after ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral~     infarction in 52 to 81% of cases.~      Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is~     currently available.~      This is a multicentre, randomized, comparative study, including 364 patients during the~     acute phase following ruptured aneurysm, in whom management is very often limited to control~     of complications, after exclusion of the aneurysm.~      The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve~     stimulation for the prevention of vasospasm and limitation of the consequences of delayed~     cerebral ischaemia after SAH.~      This is an innovative project, as it comprises intervention in these patients prior to the~     development of complications and could limit the development of these complications. The~     prevention tool, based on external facial nerve stimulation, is a totally innovative,~     reversible and noninvasive technique. Use of nerve stimulation in this indication has never~     been previously reported and could radically modify the intensive care management of this~     disease over the years to come.~   "
43863|NCT02482870|"~     The investigators studied the correlation between the Mallampati classification and the~     Cormack-Lehane grades obtained with Macintosh and the King Vision video laryngoscopy in~     adult patients scheduled for general anesthesia.~   "
43864|NCT02482857|"~     This is a single-center, open-label, randomized controlled trial. Patients with stable~     angina pectoris without use of dual antiplatelet therapy or anticoagulation therapy~     scheduled for coronary artery bypass grafting (CABG) at Karolinska University Hospital in~     Stockholm, Sweden will be eligible.~      This study investigates in patients having undergone CABG whether increasing the dose or the~     frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding~     platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg~     once daily) in the first three months after surgery. Patients will be randomly assigned to~     postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study~     dose ASA will be started at hospital discharge and continued of three months. Blood samples~     for serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before~     discharge, and after one and three months. All available data will be collected~     prospectively. Informed consent will be obtained from patients meeting the inclusion~     criteria before the initiation of any study-specific procedures.~   "
43865|NCT02482844|"~     The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy~     which is booming in the management of aortic stenosis. It concerns patients who have a high~     surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular~     replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less~     invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch~     Block (LBBB) is one of the most frequent complications of this procedure and represents an~     important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent~     pacing in 5 in 15 % of the cases in 1 year.~      De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation.~     However, there are no predictive elements of these conductive disorders. Besides, the~     incidence and the deadline of appearance of this AV disorders are not established. It seems~     relevant to propose a new stratification based on ECG and endocavitary data. The monitoring~     of the conductive disorders is allowed by remote monitoring thanks to the implantation of a~     pacemaker or an implantable holter allowing to determine the incidence and the deadline of~     appearance of high grade AV conduction disorders.~   "
43866|NCT02482831|"~     This study aims to compare the sensory and motor block duration and the incidence of nerve~     injury after sciatic nerve block between diabetic and non-diabetic patients, and screen for~     the factors that may affect the block recovery.~   "
43870|NCT02482779|"~     Health-related applications for smartphones represent a new and popular market for consumer~     oriented products. These applications are generally not considered medical devices and, as~     such, are not under the purview of the Federal Drug Administration. Some of these~     applications purport to measure vital signs, but do not have any published data to confirm~     accuracy of such measurements and their developers have not been willing to divulge the~     methods by which vital sign readings are produced.~      Use of unvalidated application derived data may contribute to patient harm as patients may~     make healthcare decisions based on the results these applications provide. This study aims~     to assess the accuracy of several such applications by comparing their findings to those of~     clinical vital sign monitors commonly used in the perioperative setting.~   "
43871|NCT02482766|"~     The primary hypothesis of this study is reduction in need of mechanical ventilation in the~     first 72 hours of life (excluding the transient tracheal intubation performed for surfactant~     administration and the mechanical ventilation for lung recruitment) in spontaneously~     breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24~     hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no~     recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt~     extubation.~   "
43872|NCT02482753|"~     This study was to evaluate the efficacy and safety of Chidamide in combination with~     exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.~   "
43873|NCT02482740|"~     The investigators design a phase 2, open labeled, randomized trial of Tamoxifen (20 mg/day)~     and Letrozole (2.5 mg) in treatment of squamous carcinoma of the cervix. Forty four patients~     with recurrent or persistent disease will be recruited, randomized, treated and followed~     three-monthly for 12 months. The primary end point is the treatment response rates.~     Secondary end points include survivals, ECOG performance status, quality of life and~     efficacy of biomarkers in predicting the responses. Candidate biomarkers including ER, PR,~     GPER and HPV genotype in paraffin cancer tissues as well as methylated genes in the blood~     will be studied in relation to the therapeutic outcomes.~   "
43874|NCT02482727|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet,~     leads to beneficial changes in muscle strength at low resistance and minimal stress on the~     nearby joint. This novel resistance training has the potential to greatly improve muscle~     strength gains in individuals who are unable, for medical reasons, to perform the high~     resistance exercises typically required to improve strength. Our study will examine the~     effect of this technique on strength recovery following distal radius fracture repair. The~     primary objective of the intervention is to achieve accelerated recovery of forearm, wrist~     and hand function as assessed using measures such as grip/pinch strength, validated~     questionnaires, and functional outcome testing. Occlusion training can potentially serve as~     a specialty intervention for rehabilitation patients, reduce the cost of care, and improve~     the treatment options for both patients and providers.~   "
43875|NCT02482714|"~     The primary purpose is the evaluation of life quality of Fibromyalgia patients. The~     investigators' main hypothesis includes the role of geographical, sociological,~     psychological and physical activity on life quality.~   "
43876|NCT02482701|"~     To confirm performance of the Captivator™ EMR device for resection of early neoplasia in~     Barrett's Esophagus.~   "
43877|NCT02482688|"~     Stroke is the number one cause of disability in the United Nations with about 1 million new~     cases each year. Following stroke, patients with perceptual and cognitive impairments have~     the worst prognostic outcomes. There is evidence to suggest that perceptual and cognitive~     symptoms can be alleviated by multisensory integration, which has the effect of enhancing~     motor, perceptual and cognitive processes. This research project will investigate for the~     first time the functional benefits that stem from multisensory stimulation of attention in~     stroke patients with perceptual and cognitive impairments. The research project will involve~     multisensory learning paradigms with stimulus and environmental parameters that optimally~     enhance perceptual learning and cognitive function. Multisensory learning paradigms will be~     tailored for patients with stroke to determine the perceptual and cognitive symptoms that~     can be alleviated, and fMRI will be used to evaluate the underlying neural substrates of the~     effects. The project will show whether multisensoty stimulation provides an effective means~     of attentional rehabilitation after stroke and whether the effects generalize to everyday~     life, with long-term outcomes that improve functional independence in patients with stroke.~   "
43878|NCT02482675|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term~     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function~     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a~     lower risk of CVD, but whether these effects occur directly or indirectly by displacing~     foods in the diet that might increase CVD risk is unclear. The health benefits of dairy on~     heart health are at least partly attributed to its ability to limit PPH and resulting~     PPH-mediated responses leading to vascular dysfunction. This provides rationale to further~     investigate dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of~     this study is to define the extent to which dairy milk, and its whey and casein protein~     fractions, protect against postprandial vascular dysfunction by reducing oxidative stress~     responses that limit nitric oxide bioavailability to the vascular endothelium in adults with~     prediabetes.~   "
43879|NCT02482662|"~     Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral~     glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while~     fasting since midnight and to stay sober for another two hours. These OGTTs are poorly~     tolerated by pregnant women. As many OGTT are false positive according to self-monitoring~     blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results~     that are false negative.~      The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of~     OGTT will determine the exact percentage of false negative OGTT results.~      The opinion of women will also be taken into account. In the everyday clinic, many report~     that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable~     drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been~     performed, the investigators will investigate formally what women think using a~     questionnaire.~   "
43880|NCT02482649|"~     The aim of this study is 1) to investigate clinical effects of equine-assisted activities~     and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to~     compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This~     study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of~     EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered~     at baseline and after EAA/T or drug therapy.~   "
43881|NCT02482636|"~     This multicentre, parallel group, block randomised clinical trial aims to investigate the~     post booster antibody response in UK infants given a reduced priming schedule of~     meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will~     provide information about how best to include the meningococcal B vaccine (likely to be~     introduced late 2015) into the routine immunisation schedule.~      The UK Department of Health provides a routine vaccination schedule for children in the UK~     and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The~     Department of Health have announced that the meningococcal B vaccine (Bexsero) be introduced~     to the routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by~     removing the current MenC conjugate vaccine dose given at 3 months of age. There is no~     published immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1~     schedule) and with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the~     infant programme.~      This change to the schedule would result in three injections at 2, 4 and 12 months, and~     given previous reluctance among parents for three injections at one visit, an option to~     reduce PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be~     assessed in this study.~   "
43882|NCT02482623|"~     Persons with dementia and their caregivers are often cared for in the community through home~     healthcare (HHC). While these patients and their caregivers need significant help and often~     have difficulty maintaining their quality of life, home healthcare clinicians are often~     unprepared to care for this population. This study will therefore examine the ability of an~     integrated, multi-pronged evidence-based practice intervention for home healthcare~     registered nurses, occupational therapists and physical therapists, the DSM-H, to improve~     the quality of care and quality of life for persons with dementia and their family~     caregiver. The investigators will enroll persons with dementia and their family caregiver~     upon admission to the HHC agency and examine their quality of life over 60 days following~     admission, comparing those who receive the intervention to those who serve as controls.~   "
43883|NCT02482610|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term~     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function~     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a~     lower risk of CVD, but whether these effects occur directly or indirectly by displacing~     foods in the diet that might increase CVD risk is unclear. Further controversial is the~     extent to which dietary fat derived from dairy foods regulate the risk of CVD. The health~     benefits of dairy on CVD risk are at least partly attributed to its ability to limit PPH and~     resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to~     investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart~     disease. The objective of this project is to define the extent to which full-fat dairy milk~     compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing~     oxidative stress responses that limit nitric oxide bioavailability to the vascular~     endothelium in adults with prediabetes.~   "
43884|NCT02482597|"~     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a~     diverse and growing list of disorders including cardiovascular disease 6. During WBPA,~     patients lie in the supine position on a bed that is capable of translating back and forth~     parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is~     best described as a form of passive exercise. The frequency of the translation (up to 180~     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by~     the patient or health care professional.~      The science behind the therapeutic effects of WBPA still remains largely unknown.~      The objective of this study is to determine if WBPA may be used as an effective way to~     reduce lactic acid concentrations during recovery after intense exercise more rapidly than~     previously established methods.~   "
43885|NCT02482584|"~     The purpose of the trial is to investigate the effects of three months' treatment with a~     CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D)~     patients with newly detected Obstructive Sleep Apnoea (OSA).~   "
43886|NCT02482571|"~     The primary objective of this research is to measure neurochemicals in the activated human~     brain during both normoxia (normal oxygen availability) and induced mild hypoxia (reduced~     oxygen availability).~   "
43887|NCT02482558|"~     The aim of this study is to investigate the effect of a one week high versus low glycaemic~     index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in~     a two way cross overs study and to see if there is any correlation between this and satiety~     or appetite.~   "
43888|NCT02482545|"~     Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high~     fiber meal replacement in overweight individuals, on body composition.~      Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of~     disease. Procedures (methods): In a randomized control intervention, subjects will complete~     5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing~     sessions) as well as an 8 week intervention period. Pre-screening will include written~     informed consent, health history questionnaire, nutrition analysis, and baseline~     anthropometric measures. Baseline testing will be split into two sessions and include~     measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,~     mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory~     fitness assessment.~      Subjects will be randomly assigned to treatment (8 week supplementation with meal~     replacement to be taken at breakfast) and control groups (continue normal eating habits)~     with 4 electronic correspondences throughout the supplementation period. All measures will~     be repeated in two post-testing sessions.~   "
43889|NCT02482532|"~     The researchers will investigate if modified T-cells from a patients own system can be~     utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.~   "
43890|NCT02482519|"~     Marrow adipocytes have been identified as a component of the bone marrow micro-environment.~     Evidence exists suggesting that marrow fat plays an important physiologic role in both bone~     mineral and energy metabolism in humans. The investigators will study the effects of acute~     weight gain and acute nutritional deprivation on energy homeostasis and bone mineral~     metabolism by examining marrow adiposity, peripheral fat depots and bone microarchitecture.~      The study will include two ten day inpatient study visits. Participants will eat a high~     calorie diet for 10 days, followed by a 13-18 day stabilization period at home, and then~     return for a ten day fast.~   "
43891|NCT02482506|"~     This is a randomized intervention study to examine the effects of the Moving Forward Guided~     Weigh Loss Intervention compared to a self-guided weight loss program on BMI and behavioral,~     biological, and psychosocial outcomes in overweight and obese African American women~     diagnosed with Stage I, II, or III breast cancer.~   "
43892|NCT02482493|"~     Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures.~     Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main~     goal of TKA is to relieve the disabling pain of arthritic disease.~      Patient satisfaction following TKA is related to quick recovery and return to daily~     activities. This can be dependent on the design of the implant used in the knee.~     Improvements in implant design and surgical technique mean many modern designs offer implant~     survival rates beyond 10 - 15 years.~      As cost pressure increases in the NHS the unit cost of implants is now being scrutinised,~     particularly with regard to cost effectiveness. The Press-Fit Condylar (PFC) Sigma implant~     can be used with either a conventional metal backed or alternatively an all polyethylene~     tibial component (part fitted to the shin bone), the latter considerably cheaper to~     manufacture. Four small prospective randomised trials and one large regional registry study~     with long follow up support the safe use of all polyethylene tibial components in TKA. The~     investigators will therefore undertake a prospective randomised controlled trial comparing~     the results of all polyethylene tibial components with those of conventional metal backed~     tibial components in patients aged 75 or over, comparing both clinical outcome and~     radiological survivorship.~      The type of knee replacement used for each patient (metal-backed or polyethylene) will be~     chosen at random once a patient has agreed to take part in the study.~      Data will be collected by means of follow-up appointments and questionnaires and clinical~     tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow~     us to see how both types of knee replacement perform over time and if one performs better~     than the other in terms of patients movement, pain and functional activities.~   "
43893|NCT02482480|"~     Study objetives : The aim of this study is to assess the impact of a combined therapy~     treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on~     symptoms and quality of life in patients with OSAS, as an alternative or addition to~     therapeutic treatment with nocturnal CPAP.~   "
43894|NCT02482467|"~     Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not~     described to date.~   "
43895|NCT02482454|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     cholangiocarcinoma.~   "
43896|NCT02482441|"~     This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability,~     and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with~     metastatic colorectal cancer.~   "
43897|NCT02482428|"~     The LFX453X2202 study will test the investigational drug LFX453 against placebo for safety,~     tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an~     additional open label arm using imiquimod 5%.~      During the study the patients will receive either LFX453, placebo or active comparator and~     the tolerability and safety will be assessed continuously through local tolerability~     assessments and adverse event recording. Efficacy will be clinical evaluations and lesion~     count. During the study biopsies will be taken for analysis of pharmacokinetics and~     biomarkers. Blood samples will be taken for safety, pharmacokinetics (PK), and biomarkers.~   "
43898|NCT02482415|"~     Health care systems are increasingly using outpatient care for patients with advanced cancer~     disease with complex needs, limited life expectancy, and need for palliative care. Family~     caregivers are centrally important, but are often insufficiently prepared for the caregiving~     role, and experience psychological distress and physical symptoms. We hypothesize that a~     psycho-educational intervention during ongoing palliative care will support family~     caregivers' wellbeing and decrease negative consequences of caregiving.~      The intervention, which has been developed in steps through a series of studies based on~     theoretical, methodological, and empirical work, was delivered in a group format 2013-2014.~     Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each~     meeting had a specific topic presented by a member of the palliative care team (physician,~     nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with~     the participants.~      The overall aim of this ongoing project is to investigate short and long-term effects of the~     intervention delivered by health professionals at ten specialized palliative home care~     units. Multiple methods are now being used, including a randomized controlled trial (RCT).~     In total, 270 family caregivers have been requested to answer a questionnaire at four time~     points: at baseline, upon completion and again 2 months after completion of the~     intervention, and 6 months after the patient's death. The primary outcome variable is~     preparedness for caregiving, and the secondary outcome variables cover aspects of wellbeing~     including competence and reward, caregiver burden, health, anxiety and depressive symptoms,~     and grief. These data will be complemented with interviews.~      The project has the potential to contribute knowledge about the development of support for~     family caregivers, not only in specialized palliative care but also in other contexts such~     as elderly care and general home care services.~   "
43899|NCT02482402|"~     Trial Rationale/ Justification To assess efficacy and safety of inhaled Iloprost in~     treatment naïve patients with left heart failure and pulmonary hypertension, who are on the~     waiting list for orthotopic heart transplantation. As patients often show increasing~     hemodynamic values while waiting for a donor organ, the transplantation becomes infeasible~     at the time of identification of an appropriate donor organ when reaching the exclusion~     limits. Therefore, there is a high need of improvement and stabilisation of the patients'~     hemodynamic values as PVR, PAP and TPG. In a retrospective, non-controlled study inhaled~     Iloprost has already shown a beneficial effect on the hemodynamics as reduction of PVR, TPG~     and CI (Schulz 2010). Treatment with inhaled Iloprost could stabilize the hemodynamics and~     prevent the patients from being classified as ineligible by the time an appropriate donor~     organ is identified.~      However, the adverse event profile regarding frequency, time-dependency has to be further~     validated to show safety and tolerability of inhaled Iloprost in this indication.~      All patients can be transferred to a long-term medically supervised observation period with~     inhaled Iloprost therapy.~   "
43900|NCT02482389|"~     This protocol seeks to utilize a novel method of tumor bed boost delivery and to better~     understand breast cancer radiation response through the analysis of pre-and post-radiation~     breast tumor samples.~   "
43937|NCT02481908|"~     The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a~     method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the ED for~     Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs~     measured under Valsalva manoeuver (VM) could improve the distinction between patients with~     LVD and those without LVD.~   "
43901|NCT02482376|"~     This protocol seeks to build on the favorable results of the investigators' phase I trial~     (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the~     investigators hypothesize that 21Gy (Gray) can be delivered preoperatively to a larger group~     of subjects and that pathologic complete response will be observed in 20%. The investigators~     propose a novel method of tumor bed boost delivery.~      The study team hypothesizes that the boost can be delivered preoperatively to the intact~     breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate~     that pre- and post-radiation breast tumor samples will provide an avenue for understanding~     breast cancer radiation response~   "
43902|NCT02482363|"~     Season of birth influences pregnancy for reasons that remain unclear however the answer may~     lie in the amount of sunshine pregnant women are exposed to. Sunshine, or ultraviolet light~     (UV) exposure is already known to have benefits for health on heart disease, strokes and~     depression. In pregnancy, relationships between sunshine exposure are evident in birth~     weight, preterm birth and risk of blood pressure complications. Vitamin D, the UV generated~     hormone, was thought to be responsible when low vitamin D levels were associated with these~     pregnancy complications. However, vitamin D replacement is ineffective at preventing these~     outcomes, and the investigators hypothesise that this is because it is the UV that is~     beneficial for pregnancy and it is working through a different pathway.~      A new understanding of skin function is central to this, with a 2014 study showing that~     exposing an adult to 20 minutes of low dose UV light lowered their blood pressure and~     improved blood flow. These investigators demonstrated this was a direct effect of UV on the~     skin and was mediated by nitric oxide, a chemical central to many aspects of pregnancy~     including blood pressure regulation and uterine activity.~      The investigators in this study have funding from Tommy's to investigate if a similar effect~     is seen in pregnancy on the circulation. The design is similar to the previously successful~     method and volunteers would be recruited from clinical areas during the second trimester. As~     both resting and warming for 20 minutes have the potential to have similar effects on the~     circulation, a control arm will expose participants to these without the UV.~      This pilot study would involve one visit and measurements taken would include heart rate,~     blood pressure, arteriography, ultrasound of the uterine arteries and blood measurements of~     nitric oxide levels. Arteriography is performed using a specialised arm cuff and is safe and~     non-invasive. A subset of these women would be invited to repeat this in the third trimester~     to investigate for a difference in effect at a later gestation.~   "
43903|NCT02482350|"~     Hemianopia refers to compromised vision in one half of the visual field, in either one or~     both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually~     caused by stroke or head injury. In order to read, participants have to move their eyes~     along a line of text three to four times per second. Such eye movements are called saccades.~     One makes use of peripheral visual information to the right (if reading from left to right,~     e.g., in English) or to the left (if reading from right to left, e.g., in Arabic) of words.~     HA patients are deprived of much of this information. Patients with HA require far more~     saccades, which slows their reading significantly and often prevents them from reading~     efficiently for work or pleasure. It follows that the reading ability of those who read~     left-to-right would be compromised more by right-sided HA, and in those who read~     right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of~     left-sided HA following stroke, in Arabic readers. An online treatment package has been~     developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or~     treatment resources exist for the condition in right-to-left readers. The aim is to develop~     novel Arabic reading tests and rehabilitation material. The current project proposes to 1)~     translate this package into Arabic, 2) develop new Arabic reading test materials and 3)~     collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to~     develop an effective, novel, and empirically supported reading treatment package for Arabic~     readers with HA.~   "
43904|NCT02482337|"~     The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure~     is an effective treatment for people with achalasia.~   "
43905|NCT02482324|"~     This is an open-labeled, cross-over design, pharmacokinetic study, to determine the~     pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and~     ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in~     healthy volunteers, aged 55-75, and in good general health.~   "
43906|NCT02482311|"~     This is an open-label, multi-centre, Phase Ib study of AZD1775 designed to assess the~     safety, tolerability, pharmacokinetics, and anti-tumour activity of AZD1775 monotherapy in~     patients with advanced solid tumours.~   "
43907|NCT02482298|"~     The purpose of this study is to determine whether ticagrelor is effective in reducing the~     number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle~     cell disease~   "
43908|NCT02482285|"~     This study is looking at the feasibility of performing frailty assessments on elderly~     patients with advanced cancers~   "
43909|NCT02482272|"~     The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus~     Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with~     LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir~     or Adefovir~   "
43910|NCT02482259|"~     This study is looking at the feasibility of performing frailty assessments on patients with~     advanced hepatocellular cancer.~   "
43911|NCT02482246|"~     Healthy parturients presenting for scheduled cesarean delivery will have blood drawn and~     measured for microparticles at baseline, immediately after delivery, and at several time~     points thereafter.~   "
43912|NCT02482233|"~     The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes~     and telephone counselling (compared to transdermal nicotine replacement and telephone~     counselling) as a harm-reduction tool that may lead to increased smoking cessation in the~     perioperative setting in smokers presenting for elective surgery at the San Francisco~     Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes~     over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,~     hospital length-of-stay, postoperative complications within the first 30-days, and smoking~     status 8-weeks after randomization. This pilot study is designed to provide the preliminary~     data necessary to plan and fund a larger-scale randomized clinical trial that will assess~     the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate~     goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in~     smoking cessation, specifically in the perioperative setting where the risks of continued~     smoking are great and the motivation to stop is high.~   "
43987|NCT02481258|"~     The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows~     progression of valve calcification in patients with moderate calcific aortic valve stenosis.~     Secondary and tertiary objectives are to determine whether Ataciguat slows progression of~     aortic valve function, reduces systemic inflammation, and prevents left ventricular~     dysfunction in patients with moderate calcific aortic valve stenosis.~   "
43913|NCT02482220|"~     Acute exercise of high intensity has been shown to induced nutritional adaptations in obese~     adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise~     (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy~     consumption at the following meal with no modification of their appetite feelings. Although~     it is suggested that chronic physical activity programs can induce energy intake~     modifications, this has never been clearly studied. The aim of this work is to compare~     different physical activity programs (low vs. high intensity programs) in terms of energy~     intake, appetite feelings and appetite-regulating hormones, in obese adolescents.~   "
43914|NCT02482207|"~     Investigators recently demonstrated that coronary flow reserve (CFR) significantly improved~     after rosuvastatin therapy in hypertensive patients with average levels of serum cholesterol~     by measuring the change in CFR after 1 year treatment with rosuvastatin in the RESERVE~     (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However,~     the absence of a placebo group made it difficult to exclude the possibility that lifestyle~     modification and antihypertensive medication also played a role in improving CFR in our~     previous study. In a double-blind, randomized trial, investigators try to examine the~     hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle~     modification alone in improving CFR in hypertensive patients .~   "
43915|NCT02482194|"~     The conventional treatment of spinal cord injury (SCI) includes physical therapy and~     rehabilitation and in some cases may require surgical intervention. Although improved~     emergency care and aggressive treatment can help in preventing further damage and even~     restore minimal sensory functions, still a large proportion of patients suffer with~     prolonged disabilities. It led neurologists to search out for new treatment options for this~     otherwise debilitating disorder. Recent advances in research have developed a better~     understanding of stem cell biology especially their role in tissue repair and regeneration.~     Encouraging results in pre-clinical phase and limited human trials have proved that stem~     cells can be safely and effectively delivered to the injured site for regeneration of~     damaged tissue. Although a variety of cell types have been tried for their role in repair of~     spinal cord injury, majority of clinical trials employed stem cells taken from bone marrow~     especially mesenchymal stromal cells (MSC). Bone marrow MSCs are a good choice for~     regenerative therapies owing to advantages like ease of collection and ex-vivo culturing,~     immune tolerance and their ability to differentiate into a variety of cell types including~     neuronal lineage cells. Intravenous application or direct injection of MSCs into~     cerebrospinal fluid (CSF) via lumber puncture in animal models of SCI and brain trauma had~     shown that MSCs can migrate towards and integrate into injured spinal tissue and reduce cyst~     size and increase functional recovery. The literature indicates that acute, sub-acute and~     chronic injury can be a therapeutic target for MSC grafting. The mechanism of action may~     however vary among these conditions. In acute phase, MSC administration play~     anti-inflammatory role, while in sub-acute/chronic setting it may be used as neurostimulator~     and for cell bridging effect and possibly glial or neuronal cell replacement. The~     investigators propose a non-randomized, single group, open label, phase-I, interventional~     study to evaluate the safety and efficacy of intrathecal delivery of patient's own~     (autologous) bone marrow mesenchymal stem cells for treatment of spinal cord injury. This~     will include determination of functional recovery (neuro-muscular control and sensation) in~     the affected area and overall improvement in quality of life of the patients and also take~     into account any side effects, if observed.~   "
43916|NCT02482181|"~     The purpose of this study, is to investigate the value of diffusion weighted imaging on the~     differential diagnosis of solitary pulmonary lesions.~   "
43917|NCT02482168|"~     This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal~     antibody APX005M in adults with solid tumors. Study is intended to establish the maximum~     tolerated dose and the overall safety and tolerability of APX005M.~   "
43918|NCT02482155|"~     The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen~     after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male~     and female subjects, under fasting conditions.~   "
43919|NCT02482142|"~     The study aim at:~      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming~     high carbohydrate meal.~      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming~     high protein-low phosphorus meal.~   "
43920|NCT02482129|"~     The purpose of the study is to determine whether topical ocular administration of LME636 60~     mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber associated~     (AC) with acute anterior uveitis (AAU).~   "
43921|NCT02482116|"~     This research investigates the diagnostic accuracy of various diagnostic approaches for~     malaria and pneumonia in under-five children presenting to primary healthcare centres in~     Benin City, Nigeria.~   "
43922|NCT02482103|"~     This study is a national registry of patients treated with renal denervation (RD) in the~     Netherlands.~      The aim of the study is to collect data on safety of the procedure, predictors of the blood~     pressure lowering effect, sustainability of the effect and to assess the cardiovascular~     event rate in patients treated with renal denervation.~      This is a prospective observational study.~   "
43923|NCT02482090|"~     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive~     clinical results with durable complete responses in patients with metastatic melanoma. The~     TILs are isolated from patients own tumor tissue followed by in vitro expansion and~     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of~     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion~     Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.~      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,~     including Ovarian Cancer. In this study TIL therapy is administered to patients with~     metastatic Ovarian Cancer.~   "
43924|NCT02482077|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir~     containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes~     2 infection.~   "
43925|NCT02482064|"~     Ten patients who had had maxillectomy will be assigned to two groups employing two types of~     'temporary obturators. The obturators in the first group will be made from heat cure acrylic~     resin, whereas those in the second group from flexible resin.~      A comparison will be made between the two materials in terms of oral-nasal seal using the~     drinking water test as well as the mirror test.~   "
43926|NCT02482051|"~     The purpose of this study is to develop a new and very rapid diagnostic test for identifying~     a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of~     bacteria will assist in decreasing the use of antibiotics and help more patients survive bad~     bacterial infections of the blood.~   "
43927|NCT02482038|"~     This study is designed to look at the effect of the geko device on the circulation in lower~     limbs of participants with venous leg ulcers.~   "
44047|NCT02480465|"~     Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by~     Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.~   "
43928|NCT02482025|"~     Medication discrepancies, defined as unintentional differences found between patients'~     medical records and patients' reports of the medication they are taking, occur frequently~     after hospital discharge, predisposing to adverse drug events (ADEs), emergency department~     visits and readmissions. Resolving medication discrepancies - medication reconciliation - is~     mandated at every care transition, but little is known about intervention strategies to~     improve medication reconciliation in the post-discharge period, when patients may lack~     prompt access to primary care and are at high risk for ADEs. To address this gap, the~     investigators developed and pilot tested the Secure Messaging for Medication Reconciliation~     Tool (SMMRT), with a pharmacist communicating with Veterans to review medications and~     reconcile discrepancies after hospital discharge via Secure Messaging (SM), within My~     HealtheVet (MHV), VA's patient portal. The objectives of The SMMRT Trial are therefore~      To optimize the end-users' experience with SMMRT through usability testing and refinement of~     the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus~     MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To~     evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices~     and, specifically, on Veterans' interactions with their primary care providers.~   "
43929|NCT02482012|"~     Infants comprise a potentially vulnerable research population that received special~     consideration and protections under the US Code of Federal Regulations - Subpart D. Of the~     four categories of research involving children, 45 CFR 46.406 is of particular interest to~     researchers, ethicists, parents, and clinical staff members since it concerns the conduct of~     research with more than minimal risk without the prospect of direct benefit. Parents are~     the surrogate decision makers for infants. When asked about this type of research in studies~     pertaining to older infants and children, parent themes include: concerns of medical~     research and research-related risk, desire to advance generalizable medical knowledge and~     knowledge specific to their own child's disease. There are no data on parents' perceptions~     regarding this category of research that target the premature, late-preterm and term newborn~     populations.~      This study involves a questionnaire for both staff (nurses and physicians) and parents. The~     questionnaire represented 4 different infant scenarios in a random order. Respondents are~     asked to answer questions related to enrollment in a research study for each of the 4~     scenarios.~   "
43930|NCT02481999|"~     Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence~     agitation as well as on postoperative cognitive function in children aged 0,5-8 years~     scheduled for elective surgery. The depth of anesthesia in children for elective surgery~     aged 0,5-6 years is monitored with intraoperative Narcotrend-Compact-M-Monitoring.~     Postoperatively the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) [Sikich et~     al. 2004] is used to screen for the frequency of postoperative delirium in the post~     anesthesia care unit discharge of the child after surgery. Cognitive testings are performed~     in children of the study group (n= 470) and a control group (n= 80) with the parents support~     to evaluate deficits in children in their cognitive areas (POCD (Postoperative cognitive~     deficit)) at three different time points up to three months.~   "
43931|NCT02481986|"~     The Asthma Action at Erie Trial compares the current best practice in asthma self-management~     education (certified asthma educator services) to an integrated community health worker~     (CHW) home intervention in which the real-life challenges of patients and the health care~     system are taken fully into account. This trial will provide clarity as to the expected~     effect size, cost savings, and resources needed to integrate asthma CHWs into clinical~     practice.~   "
43932|NCT02481973|"~     Premenstrual syndrome (PMS) is related to the changes in the levels of hormones~     predominately progesterone, oestrogen and prolactin, during the luteal phase of the~     menstrual cycle. Both physical and psychological symptoms may occur from at least day 14 of~     the menstruation cycle and cease by day 4 of menstruation. The symptoms may interfere with a~     female's daily activities and have a negative impact well-being. There are a number of~     conventional pharmacological drugs which are used in the treatment or alleviation of the~     symptoms of PMS, however the drugs may have side effects and may negatively interact with~     other medications. Research has shown that homoeopathy is beneficial in relieving or~     decreasing the severity of PMS, however finding the individualised homoeopathic remedy can~     be difficult. Grant Bentley developed a system that helps find the most suitable remedy for~     each individual case. The Grant Bentley Method (GBM) uses homoeopathic case taking,~     photographs of the facial features and repertorisation to determine the dominant miasmatic~     group of the patient. This aids in the selection of specific homoeopathic remedy. There has~     been no research to show the effect of the GBM on PMS.~      This study aims to determine the effect of individualised homoeopathic treatment using the~     GBM, on females with PMS by using case studies and a daily self-grading PMS chart.~   "
43933|NCT02481960|"~     A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan~     hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).~   "
43934|NCT02481947|"~     The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and~     efficacy versus lubiprostone in constipated adults.~   "
43935|NCT02481934|"~     The purpose of this study is to determine wether activated and expanded autologous Natural~     Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on~     second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as~     lenalidomide or bortezomib.~   "
43936|NCT02481921|"~     The primary goal of this proposal is to improve the quality of care and outcomes for~     patients discharged with heart failure using an innovative multidisciplinary group~     intervention approach. Heart failure is a complex chronic illness where comprehensive~     patient-centered care is difficult and resource intensive. One potential solution is to use~     shared medical appointments (SMA), where a multi-disciplinary team of providers with~     expertise in nutrition, nursing, behavior and medication management join to manage heart~     failure. The investigators will enroll patients from Providence, Cleveland and Phoenix VA~     Hospitals who were within 12 weeks of discharge from a heart failure hospitalization and~     randomized them to receive SMA intervention or usual care. Results from this project are~     expected to add an innovative intervention that could improve outcomes important for both~     the patient and the VA: health status, hospitalizations, and mortality.~   "
43938|NCT02481895|"~     Between 40% and 60% bipolar patients experience neurocognitive impairment not only during~     acute mood episodes but also during remission periods. These rates are quite similar to~     those reported as regards to functional impairment. In fact, it is estimated that only one~     third of patients achieve full social and occupational recovery and get back to their~     premorbid levels. Moreover, neurocognitive deficits, together with other clinical and~     sociodemographic variables are thought to contribute to functional impairment for bipolar~     disorder, similarly to that found in schizophrenia. Little is published with regard to~     neurocognitive remediation in bipolar disorder. The first open label study on bipolar~     disorder was published in 2010 with positive results. Recently, a multicenter randomized~     clinical trial coordinated showed efficacy of an innovative intervention at improving~     functioning and reducing disability of bipolar patients. There is a need of investigating~     novel and creative ways to work on cognitive deficits including new technologies in order to~     reduce costs and increasing benefits for patients. No study addressing computerized~     cognitive training in bipolar disorder has been developed so far. This project aims to test~     the efficacy of an e-neurocognitive module as an adjunct to functional remediation in~     bipolar patients.~   "
43939|NCT02481882|"~     This study will provide information on cortical haemodynamics in MS patients to address the~     discrepancies reported in previous literature, allowing further insight into the role of~     haemodynamics in the disease. It will also instruct us as to the most effective scanning~     protocols for future research. Developing a suitable protocol for studying perfusion~     longitudinally may also enable identification of new therapeutic interventions to normalise~     any perfusion abnormalities in MS patients.~   "
43940|NCT02481869|"~     Patients who sustain broken ankles have a very high risk of developing arthritis soon after~     injury (within 2 years). This arthritis can cause increased pain and a decrease level of~     function, especially if the injury occurs at an early age. During and shortly after ankle~     injury, there is an inflammatory chemical process that takes place in the ankle that can~     cause damage to the cartilage in the ankle joint. The investigators want to use what is~     called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's~     own blood, to inject into the injured ankle to see if they can decrease the inflammation~     that happens after the injury and to see if they can decrease arthritis.~   "
43941|NCT02481856|"~     The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled~     multi-site trial conducted in Canada. Before the start of treatment, the subjects will~     undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment~     duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber~     sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber~     session after 24 weeks of treatment.~   "
43942|NCT02481843|"~     Prospective observational study in 40 adult critically ill patients. Patients were eligible~     if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and~     hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood~     transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients~     (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20~     patients were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline,~     24h and 48h. Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at~     baseline (t0), after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2~     (t2). Sidestream dark field videomicroscopy was applied sublingually to assess the~     microvascular response to hyperoxia. Near infrared spectroscopy with a vascular occlusion~     test was applied at t0, t1, t2.~   "
43943|NCT02481830|"~     The purpose of this study is to compare the overall survival of nivolumab versus~     chemotherapy in subjects with relapsed SCLC.~   "
43944|NCT02481817|"~     The study is aimed at answering the questions; (1) How well do the most commonly used~     treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each~     approach?~      With the results of this trial, the investigators hope to provide information to iSGS~     patients: (1) Given my personal characteristics, conditions, and preferences, what should I~     expect will happen to me? and (2) What are my options, and what are the potential benefits~     and harms of these options?~   "
43945|NCT02481804|"~     This study aims to investigate if optimal personalized consultation by a dietician for a~     healthy diet focused on food which contains sufficient vitamins and minerals improves~     gastrointestinal symptoms as determined by an improved score in the gastrointestinal~     symptoms of the NET specific EORTC QLQ-GINET21 at end of study.~   "
43946|NCT02481791|"~     What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold~     episodes in children having cardiac MR imaging with general anaesthesia?~   "
43947|NCT02481778|"~     Rationale:~      Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically~     relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In~     particular, the relationship between radiation dose parameters and the risk of cardiac~     toxicity remains to be determined.~      Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long~     latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro~     BNP and hs-TNT, as obtained during and after treatment may be of great value.~      Objective:~      The main objective to find a correlation between the rise in NT pro BNP level and the~     radiation dose given to the heart.~   "
43948|NCT02481765|"~     Transcranial direct current stimulation (tDCS) is a method which enables noninvasive~     electrical stimulation of the cortex via electrodes placed on the subject's skull. High~     definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected~     cortical areas using multiple electrodes. The purpose of this pilot trial is to study~     feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20~     sessions in healthy adults and adults with Down syndrome.~      PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered~     up to 5 days per week for a total of 20 sessions in healthy adult subjects; Part II: After~     review of the safety data for Part I is completed and reviewed by the Data Safety Monitoring~     Committee and IRB, Part II will be initiated. To assess feasibility and tolerability of~     HD-tDCS, administered up to 5 days per week for a total of 20 sessions in adult subjects~     with Down Syndrome.~   "
44418|NCT02475642|"~     The purpose of this study is to compare the efficacy and safety of PV isolation with~     continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT~     (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.~   "
43949|NCT02481752|"~     The purpose of this research study is to investigate the effect of a brief computer task~     (Approach Avoidance Task) on smoking cessation. The investigators will use a novel training~     protocol that works to target automatic thoughts and tendencies that occur outside of~     conscious control. Previous research suggests that these automatic tendencies may have a~     direct effect on certain health behaviors- like continuing to smoke despite having previous~     quit attempts.~      The investigators hypothesize that individuals in the AAT training condition will evidence a~     greater decrease in reaction times to avoid smoking-related stimuli & approach positive~     stimuli relative to those in the control condition. The investigators also expect that~     individuals in the AAT condition will exhibit superior outcomes on several quit-related~     variables as evidenced by an increase in motivation to quit smoking, an increase in number~     of days abstinent following a self-guided quit attempt, an increase in self-efficacy, and a~     decrease in urge to smoke compared to those in the SHAM training condition.~   "
43950|NCT02481739|"~     The aim of the investigators study is to know the results of the endometriosis surgery and~     particularly to highlight a benefit of this surgery on fertility.~   "
43951|NCT02481726|"~     Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards~     the solitary pulmonary nodules of lung cancer or tuberculosis.~   "
43952|NCT02481713|"~     Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on~     learning styles in improving attendance to cognitive training~   "
43953|NCT02481700|"~     The aim of this study is to get a clear view on current practice of surgical third molar~     removal in Belgium and the association with morbidity and complications.~      For this prospective cohort study, patients who visit the outpatient department of Oral and~     Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the~     Flemish Hospital Network will be participating. All included patients are referred from~     primary dental providers for the surgical removal of one or more third molars. Before~     participating, written informed consent will be recorded from all eligible subjects.~      Patients consult one of the oral and maxillofacial surgeons or residents working on the~     department of the University Hospitals Leuven for the removal of third molars. In the~     standard procedure, patients are not routinely clinically monitored after one week at the~     department.~      Pre-operative, operative and postoperative data will be collected through a questionnaire,~     extracted data from the patient's medical file and panoramic radiography. The surgeon's~     individual operation technique will be registered through a one-off questionnaire. The~     questionnaires are taken at the same time of consultation and includes a maximum of 8~     questions per time and are considered as non-invasive and a minimal burden for the patient.~     Postoperatively, patients record their recovery status and ability to resume daily- and work~     activities at day 3 and 7 by using a dairy system and, if necessary, revisit the outpatient~     department of oral and maxillofacial surgery.~   "
43954|NCT02481687|"~     Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that~     actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing~     endoscopy. The potential role of CLE has been explored in pathology of both upper and lower~     gastrointestinal tract, showing good accuracy for predicting the final histopathological~     diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its~     minute scanning area, this techology is best used in conjunction with other red-flag~     techniques to screen the mucosa for areas of interest, which can then be examined by CLE for~     a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced~     endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have~     been no studies to determine the role of this technology in the evaluation of activity in~     inflammatory bowel disease. The study protocol is based on comparing imaging findings of~     p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of~     inflammatory bowel disease. CLE might have an important role in IBD patients management, by~     assessing the inflammation, dysplasia or response to treatment.~   "
43955|NCT02481674|"~     The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy of~     VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.~   "
43956|NCT02481661|"~     Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0~     peripheral NSCLC and may retain more pulmonary function. It is not yet known whether~     anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung~     cancer. The aim of this study is to investigate whether the outcome of anatomic~     segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung~     cancer (NSCLC).~   "
43957|NCT02481648|"~     The investigators aim to evaluate the feasibility of a larger clinical trial assessing an~     exercise program during the teachable moment in patients with prostate cancer and~     measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis.~     Participants will be randomized between a 4-12 week exercise program or to standard of care~     only. Participants will be assessed at screening, baseline (day 0), throughout the trial~     intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final~     study visit 6-months post-radical prostatectomy. At each assessment, physical, biological~     samples and psychosocial assessments will take place.~   "
43958|NCT02481635|"~     This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new~     indication/population ) and phase 2 (the second phase in testing a new drug or new~     indication/population to see how effective the drug is) study of neoadjuvant (treatment~     before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine~     and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery~     in patients with pancreatic cancer that has grown to involve one of the major artery~     branches.~   "
43959|NCT02481622|"~     This non-interventional study aims to characterize the cells infected with HIV over time in~     different types of vagino-uterine tissue.~   "
43960|NCT02481609|"~     The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia~     (a loss of the sense of smell). This drug is already approved by the Food and Drug~     Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions.~     However, there is research evidence that the medication may promote nerve recovery (help~     nerves work better after they are damaged). Since anosmia involves nerve problems, we~     believe the nasal spray may help treat anosmia. The medication has been in use for many~     years for other conditions, without safety problems.~   "
43961|NCT02481596|"~     This study evaluates family-focused mobile phone-delivered intervention, called FAMS~     (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes~     in their self-management relative to an individual-focused mobile phone-delivered~     intervention and relative to a control group. The goal of this study is to ascertain if~     family-focused content delivered to the patient can improve the patients' family support for~     diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations~     (compared to an individual mobile phone-delivered intervention and compared to no~     intervention). This study also seeks to assess participants' readiness to invite family~     members to receive intervention content via text messages.~   "
43962|NCT02481583|"~     The aim of this study was to characterise the pharmacokinetic properties and assess the~     safety of different formulations of levosulpiride in healthy Chinese volunteers.~   "
43963|NCT02481570|"~     The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery~     will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest~     opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid~     respiratory depression and allow patients to respond quickly either during intraoperative~     testing or at the conclusion of surgery.~   "
43964|NCT02481557|"~     This study will assess sensitivity during a dental prophylaxis with or without the use of a~     potassium oxalate salt solution.~   "
43965|NCT02481544|"~     Psychosocial factors, including positive affect, finding meaning in the event, and managing~     emotional distress, influence prognosis following a heart attack or myocardial infarction~     (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit~     that one has received or will receive, is associated with higher levels of well-being, and~     people who are more grateful experience less stress, are less depressed, have higher levels~     of control over their environment, and more positive ways of coping. The present project~     will examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude~     journaling) to increase positive health behaviors, psychological health, and physical~     functioning in post-MI patients as compared to journaling about memorable events as well as~     care as usual alone. The investigators will study psychological and physical functioning at~     baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month~     follow-up.~   "
43966|NCT02481531|"~     This clinical trial will evaluate the growth, tolerance, and iron status of infants who~     consume an investigational infant formula containing a nutrient-rich whey protein compared~     to a previously marketed infant formula.~   "
43967|NCT02481518|"~     The purpose of this study is to determine whether magnesium preloading reduce incident of~     cisplatin induced acute kidney injury in head and neck cancer who receiving low dose~     cisplatin (40 mg/m2 weekly for 7 weeks).~   "
43968|NCT02481505|"~     This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for~     spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower~     limb. Patients undergoing elective short-duration lower limb surgery will be randomised into~     3 treatment groups (15 patients per group) to receive one of the 3 single doses of~     Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.~   "
43969|NCT02481492|"~     This is a prospect, randomized control trial to evaluate merits between flip and no flip~     technique in Shang Ring children circumcision.~   "
43970|NCT02481479|"~     Diabetes is associated with a substantially increased risk of heart failure, which is~     associated with substantial morbidity and mortality. Despite the development of new~     therapeutic strategies to improve glycemic control, recent clinical data from the~     saxagliptin assessment of vascular outcomes recorded in patients with diabetes~     mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study observed an unexpected~     finding of an excess of adjudicated heart failure hospitalizations. This excess occurred in~     the setting of pre-existing heart failure (HF) hospitalization and in those with elevated~     biomarkers for heart failure such as N terminal pro Brain type natriuretic peptide (NT-pro~     BNP). A wealth of preclinical data did not suggest a mechanistic basis for an excess of~     heart failure events, however these preclinical studies primarily focused upon prevention~     based strategies as opposed to regression studies once established heart failure was~     present. This proposal seeks to understand if and how dipeptidyl peptidase-4 inhibitors~     (DPP4i,specifically saxagliptin) may influence the development of heart failure, by~     evaluating changes in cardiac structure and function using cardiac magnetic resonance~     imaging (MRI).~   "
43971|NCT02481466|"~     The purpose of this study is to determine whether a dietary portfolio of~     cholesterol-lowering foods (viscous fibres, soy protein, plant sterols and nuts) further~     enhanced by increased levels of monounsaturated fatty acids (MUFA) and low glycemic index~     foods; together with a structured exercise program reduce the progression of carotid and~     coronary atheromatous lesions, Low density lipoprotein-cholesterol (LDL-C), and blood~     pressure, while reducing the number of individuals requiring statins.~   "
43972|NCT02481453|"~     Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in~     patients over 50. It is a slowly progressive, but today untreatable (notably by classical~     immunosuppressants) disease.~      Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T~     regulatory cells and induces autophagy (protein degradation), all parameters impaired during~     IBM.~      RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial~     evaluating rapamycine against placebo.~   "
43973|NCT02481440|"~     The purpose of this study is to evaluate the safety and efficacy of intrathecal~     administration of allogeneic umbilical cord derived mesenchymal stem cells to patients with~     spinal cord injury.~   "
43985|NCT02481284|"~     The purpose of this study was to perform a quantitative perfusion study of the undermined~     abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction~     patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion~     imaging (LDPI) was used to evaluate this.~      Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients.~     Measurements were taken and recorded within four standardized zones covering the skin~     between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial~     to caudal).~   "
43986|NCT02481271|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing Cholecystectomy.~   "
43974|NCT02481427|"~     Unicondylar knee arthroplasty (UKA) can be used as the treatment of knee OA isolated to a~     single compartment instead of TKA. Both UKA and TKA have been used for decades as a~     treatment of knee OA. However, operative indications for TKA and UKA overlaps, but they are~     not similar. Therefore, the outcome or survivorship of these procedures cannot be compared~     directly.~      Some advantages of UKA over TKA have been reported, including faster recovery time, reduced~     perioperative morbidity and mortality, a subjective preference of feeling more normal knee,~     lower cost and improved return to work and sport. On the other side national arthroplasty~     registers consistently report around a threefold increase in crude cumulative revision rate~     at 8 to 10 years for UKA compared with TKA 7-10.~      The aim of this study is to compare functional, clinical, patient satisfaction, and implant~     survival results of cementless UKA with those of cemented TKA at 2 months, 1, 2, 5 and 10~     years after the procedure. The study design is a multicenter, double-blind and randomized~     trial of knee replacement patients. The primary outcome is the Oxford Knee Score (OKS) and~     Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 year.~   "
43975|NCT02481414|"~     This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus~     (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin~     testing reagent called Candin®) in adult females over a 12 month time period. As the results~     from the Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone~     will also be tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin.~     Subjects found to be eligible for vaccination will be randomized in a double-blinded fashion~     at a 1:1 ratio. Each participant will be receiving injections four times with three weeks~     between injections. Clinical and virological responses will be assessed at 6 and 12 months.~     Safety will be assessed from the time of enrollment to 12 Month Visit. Immunological~     assessments will be made at 4 time points (prevaccination, after 2 injections, 6 month after~     4 injections and 12 months after 4 vaccinations).~   "
43976|NCT02481401|"~     Two Intensive Life Style Intervention Programs in Related Caregivers of Preschool Children~      Substantial strides have been made in the treatment of acute cardiovascular conditions, such~     as myocardial infarction and stroke, however, the global burden of cardiovascular disease~     (CVD) continues to rise at an alarming rate. Furthermore, despite the abundant data~     demonstrating a greater burden of CVD in racial/ethnic minorities, and many specific~     interventions aimed at changing risk factor patterns or behaviors in racial/ethnic~     minorities, health disparities persist. In the present study, the investigators seek to~     evaluate the impact of a multifaceted and comprehensive lifestyle intervention coupled with~     atherosclerosis imaging on reducing cardiovascular risk among minority adults living in~     Harlem, New York. The investigators believe that holistic, multi-dimensional individual and~     peer-to-peer intensive lifestyle interventions involving parents/caregivers of preschool~     children will be effective in producing favorable change in their behaviors, which will be~     sustained over time. The primary hypothesis of the study is that aggressive lifestyle~     interventions will be more effective in improving healthy behaviors and biological~     correlates in at-risk adult parents and/or caregivers of preschool children in Harlem, NY.~     In aim 1, as an initial pilot study, the investigators will identify the contextual factors,~     facilitators and barriers that may impact the implementation of a lifestyle intervention~     program for adults in Harlem, using qualitative research methods. In aim 2, the~     investigators will determine the impact of two intensive lifestyle interventions on~     promoting and improving healthy behaviors and biological parameters to lower cardiovascular~     risk, the impact of the knowledge of presence of atherosclerosis on health behaviors and the~     impact of these lifestyle interventions on atherosclerosis among approximately 600~     asymptomatic at-risk adults. Finally, in aim 3, the investigators will evaluate the~     sustainability of the impact of the two intensive lifestyle interventions on healthy~     behaviors and biological parameters 12 months after the intervention program ends.~   "
43977|NCT02481388|"~     The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory~     muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of~     the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method~     of the present research, a pilot cross-sectional study was conducted with fourteen (14)~     patients with heart failure, functional class II and III, clinically stable, with~     cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG)~     (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness~     (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and~     manometer, respectively. Before and after maximal exercise test, optoelectronic~     plethysmography was performed to evaluate the distribution of volumes, the kinematics and~     the contraction speed of chest wall muscles. The high-resolution ultrasonography was also~     used before and after the maximum test for obtaining diaphragmatic thickness~   "
43978|NCT02481375|"~     Globally, the most common cause of anemia is thought to be iron deficiency anemia (IDA).~     This was assumed to be the major cause of anemia in Cambodia, because Cambodian diets, which~     consist mainly of rice, lack iron-rich animal food sources. However, our findings from a~     previous study in Cambodia (a Canadian government funded study investigating multiple~     interventions to improve food and nutrition security) showed that IDA is almost non-existent~     and challenges this assumption. In a cross-sectional survey of 450 women from rural~     Cambodia, only 1.0% had Hb and ferritin levels indicative of IDA (Hb <120 g/L and ferritin~     <15 μg/L). A national survey conducted by UNICEF in 2014 found similarly low rates of IDA~     (Dr. Arnaud Laillou, UNICEF Cambodia). Further, other micronutrients known to be associated~     with anemia were also low (<3%) including folate and vitamins B12 and B6.~      In addition, 54% of the Prey Veng women had a genetic Hb disorder (e.g., α-thalassemias),~     which are inherited diseases that can result in a defective Hb structure and/or impair Hb~     production, either of which can reduce Hb concentration and increase the risk of anemia.~     Further, genetic Hb disorders cause ferritin and soluble transferrin receptor (sTfR)~     concentrations to increase, which reduce the diagnostic sensitivity of these biomarkers to~     identify IDA.~      In 2011, the Cambodian Ministry of Health (MOH) recommended weekly iron and folic acid (IFA)~     supplementation for all women of reproductive age, consistent with WHO guidelines. However,~     if iron deficiency is not a major cause of anemia, then at best supplementation is a waste~     of valuable resources and at worst could cause harm. Further, the justification for~     provision of multiple micronutrients among this population has not yet been proven, despite~     the push from some organizations such as the WHO. There is an urgent need to conduct a trial~     to clarify whether iron or other micronutrient deficiencies are a major cause of anemia in~     Cambodia.~      Research Objectives:~        1. To compare Hb concentration (g/L) after 12-weeks of supplementation in women to~          determine if iron significantly improves Hb concentration, compared to a placebo;~        2. To compare Hb concentration (g/L) across the four groups (multiple micronutrients with~          iron, multiple micronutrients without iron, iron alone, and placebo) after 12-weeks;~          and~        3. To determine which of the hematological indicators (ferritin, sTfR, reticulocyte count~          and hepcidin) have the strongest diagnostic ability to predict responsiveness to iron~          therapy after 12-weeks using receiver operating characteristic (ROC) analyses.~      Methods: A 2 x 2 factorial randomized controlled trial will be conducted over 12 weeks. A~     total of ~800 women (18-45 y) with mild or moderate anemia will be recruited and randomized~     to 1 of 4 groups: multiple micronutrients with iron, multiple micronutrients without iron,~     iron alone or placebo. Blood will be collected at baseline and at 1 and 12 weeks after the~     intervention and assessed for Hb, hematological biomarkers, inflammation and genetic Hb~     disorders. The investigators will use a general linear model to measure differences in Hb~     concentration across the four groups after the intervention. Receiver operating~     characteristic curves will be used to determine the diagnostic ability of the multiple~     hematological indicators to predict responsiveness to iron therapy.~   "
43979|NCT02481362|"~     This study will examine differences in habituation to foods high in sugar and fat content~     versus those that are not, in normal weight women.~   "
43980|NCT02481349|"~     The goal of this research study is to learn what patients and their caregivers think about a~     couple-based Hatha yoga program during treatment for cancer. Researchers also want to learn~     how this program may affect fatigue, distress, sleep quality, and quality of life.~      Some patients and caregivers in this study will take part in a Hatha yoga program together.~     For comparison purposes, there will also be a group of participants that does not take part~     in this program.~   "
43981|NCT02481336|"~     To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the~     clinical bioinformatics and genomic profile.~   "
43982|NCT02481323|"~     Phase II pilot randomised, factorial, short term dose escalation, open label, blinded~     intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety~     of cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease~     manifest as symptomatic small subcortical stroke.~   "
43983|NCT02481310|"~     The purpose of this study is to evaluate the effects, good and bad of a new drug called~     ixazomib (also called MLN9708), when it is given along with a common treatment combination,~     called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase~     I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted~     (either up or down) to find the maximum (highest) dose that does not cause excessive (too~     many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the~     maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted~     between cycles depending on how blood cell levels are affected between cycles. Ixazomib is~     considered investigational because it is not approved by the U.S. Food and Drug~     Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the~     last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part~     of the standard of care.~   "
43984|NCT02481297|"~     The goal of this clinical research study is to learn if lirilumab in combination with~     rituximab can help to control either CLL or SLL. The safety of the drug combination will~     also be studied.~   "
44419|NCT02475629|"~     This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of~     ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.~   "
43988|NCT02481245|"~     We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and~     safe for bipolar depression with the following specific aims:~      Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability~     of bezafibrate added to lithium for bipolar depression, especially with regard to worsening~     manic symptoms and suicidal ideation.~      We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to lithium in 20~     participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania~     Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal~     memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the~     Framingham Cardiovascular Risk Score.~      Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of~     bezafibrate added to lithium for acute bipolar I major depressive episodes.~      In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive~     pan-PPAR agonist, bezafibrate, for 20 patients with an acute bipolar I major depressive~     episode. The study may have a profound impact on the development of a novel treatment~     consistent with the mitochondrial dysregulation hypothesis of bipolar disorder and, to the~     best of our knowledge, will be the first proof-of-concept trial to assess a pan-PPAR agonist~     for bipolar disorder.~   "
43989|NCT02481232|"~     Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy~     people above 2-months-old~   "
43990|NCT02481219|"~     This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON~     2 Capsule Endoscopy System (CCE) procedures in average risk patients.~      Patients will be randomized to receive one of two bowel preparation regimens prior to~     PillCam CCE.~   "
43991|NCT02481206|"~     A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of~     treatment and control. This study will evaluate the impact of wearable cardioverter~     defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will~     enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.~   "
43992|NCT02481193|"~     The purpose of this study is to investigate the effects of different doses of cisatracurium~     pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.~   "
43993|NCT02481180|"~     The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of~     T0001 in Rheumatoid Arthritis.~   "
43994|NCT02481167|"~     The purpose of this study is to identify age-related changes in chinese meibomian glands~     that may be associated with meibomian gland dysfunction (MGD).~   "
43995|NCT02481154|"~     This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of~     AG-881 in advanced solid tumors, including gliomas, that harbor an IDH1 and/or IDH2~     mutation.~   "
43996|NCT02481141|"~     The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC~     at doses up to 200 mg per day in subjects with type II diabetes.~   "
43997|NCT02481128|"~     Sentinel node biopsy is a well established tool for axillary staging in early breast cancer.~     So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to~     clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective~     randomized multicenter study design.~   "
43998|NCT02481115|"~     The investigators hypothesize that critical care trained registered nurses and physicians~     can perform measurements of cognitive impairment in critically ill pediatric patients in a~     reliable and valid manner. To test this hypothesis, the investigators will incorporate an~     instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in~     critically ill pediatric patients at least 6 months to children 5 years of age, both on and~     off mechanical ventilation, and compare these assessments to those of the reference~     standard.~   "
43999|NCT02481102|"~     The objective of the Registry is to provide post market clinical outcome and potential~     health economics data and confirm the continued safety of the EpiAccess system.~   "
44000|NCT02481089|"~     Warburg effect is an important feature of tumors,and genetic variation is one of the main~     factors of individual differences to radiotherapy treatment response for nasopharyngeal~     carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg)~     was related to the prognosis of NPC; Using the method of proteomics, investigators~     discovered glycolysis related gene such as PGK1, ALDOA，was associated with~     radiosensitivity.Thus,with all the previous work,investigators hypothesize that the key gene~     polymorphisms in glycolytic pathway, such as p53 , influence the glycolytic pathway,which~     leads to differences in radiosensitivity of NPC. This projects will include 600 cases of~     patients with NPC to detect common glycolytic key genes polymorphisms. Besides,investigators~     correlate these factors with their radiosensitivity and prognosis.Then, prediction model~     will be established, and validation of the prediction model will be done. Using~     enzyme-labeling instrument ，comet assay and clonogenic assay，cytological experiments will~     further investigate the influence of key gene polymorphisms on the glycolysis efficiency and~     mechanism of radiation sensitivity.Thus,investigators could provide theoretical basis of~     individualized treatment for NPC.~   "
44001|NCT02481076|"~     The aim of this project is to find out if compression treatment can lower the incidens of~     surgical wound complications, such as infection and wound rupture, in patients with ankle~     fractures. The compression regime consists of a two-layered compression stocking applied~     after surgery and a massage boot applied both before and after surgery.~      The largest part of the study is the clinical trial, with which we aim to prove the~     hypothesis:~      * That the compression regime reduces wound infections from 10-40% to 5% on patients with a~     broken ankle (Either one side of the ankle, two or three sides (including the posterior part~     of the ankle))~   "
44002|NCT02481063|"~     This study evaluates the changes in muscles and tendons in the lower limb after an~     intervention of fatigue during 3 consecutive days between trained or not healthy subjects.~     One of the 2 groups received training by eccentric overload previously.~   "
44003|NCT02481050|"~     This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate~     administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with~     HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.~   "
48170|NCT02426541|"~     This is an 8-week, single centre, randomized, parallel-group, double-blind,~     placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific~     insulin sensitivity in patients with Type 2 diabetes mellitus.~   "
44004|NCT02481037|"~     At least half of children with asthma have poor disease control, which can result in~     complications requiring emergency treatment and hospitalization. As asthma is one of the~     most common reasons for children to visit emergency departments (ED) and be hospitalized,~     this disease places a heavy burden on the health care system and families. While there is~     strong evidence that timely treatment with preventative therapies can substantially improve~     asthma control, reduce sudden worsening of symptoms, and lower rates of ED visits and~     hospitalizations, a significant proportion of children do not receive these therapies.~      The purpose of this study is to improve the prescription and use of evidenced-based~     preventative therapies for children with asthma with the goal to significantly improve their~     disease control and quality of life, while reducing unnecessary ED visits and~     hospitalizations. The investigators will achieve this by: i) installing a primary care~     clinical pathway for managing childhood asthma into clinicians' electronic medical record~     (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic~     disease management (CDM) health professionals to provide targeted and timely asthma~     education to parents and children with asthma. The investigators will test this pathway and~     education project in a representative sample of 22 Alberta primary care practices, using a~     pragmatic cluster controlled trial methodology.~   "
44005|NCT02481024|"~     Background:~      Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor~     adherence is associated with increased risk of rehospitalisation along with higher rates of~     morbidity and mortality. After a cardiac event, transitioning from hospital into primary~     care can be problematic if it is not organised or coordinated properly. Patients can often~     find themselves unprepared and lacking the necessary information for self-management of~     their disease. The impact of care transition on medication adherence has not been studied in~     ACS.~      Objectives:~      This study will explore how an ACS patients' journey from hospital into primary care affects~     medicines use. Further, to understand how medicine information is communicated and how this~     influences patient beliefs about medicines.~      Methods:~      This is an interview study with recently hospitalised ACS patients discussing medication~     beliefs, communication of medicine information and the challenges when transitioning from~     specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS~     Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An~     inductive thematic analysis will be used to identify, construct and analyse patterns in the~     data and to develop a framework analysis. Analysis will be an iterative process conducted in~     parallel with data collection to highlight when data saturation has been reached.~      Dissemination:~      The primary objective is to develop a pharmacist-led behaviour change intervention to~     improve rates of medication adherence following an ACS. The in-depth patient data collected~     in this current study will contribute to the design and development of the intervention.~     Understanding the research topic from the patients' perspective is a necessity when~     designing an intervention targeting behaviour change.~   "
44006|NCT02481011|"~     The true incidence and risks of intracranial hemorrhage (ICH) in patients on various~     antithrombotic treatments remain unknown. Here a nationwide study is conducted to~     investigate the risk for and incidence rates of ICH in users and non-users of various oral~     antithrombotic drugs in Norway between 2008 through 2014.~      Hopefully, this study will contribute to a more responsible prescription pattern of~     antithrombotic medications.~   "
44007|NCT02480998|"~     This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent~     vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in~     healthy Korean males and females 19 to < 65 years of age.~   "
44008|NCT02480985|"~     Damage to the pituitary gland is a frequently overlooked but potentially important~     complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause~     dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur~     immediately or several months after TBI, may delay recovery and may have a significant~     negative impact on quality of life. TBI is the leading cause of disability and major~     permanent functional impairment among adults under 45 years of age. Hormonal deficits may~     contribute to common symptoms experienced by TBI survivors such as fatigue, poor~     concentration, depression and low exercise capacity. However, the association between~     hormonal deficits and disability remains uncertain. The primary objective of this pilot~     study is to assess the feasibility of a larger study that will evaluate the impact of~     pituitary disorders on neurological disability and functional recovery. The results of this~     study will provide key findings in the impact of pituitary disorders following TBI, which is~     a mandatory step prior testing the effect of hormonal replacement therapy in this population~     in costly clinical trials. If no relationship between pituitary disorders and disability is~     observed, the investigators' findings will prevent unnecessary, time-consuming and costly~     hormonal screening and will discourage potentially harmful hormonal therapy.~   "
44009|NCT02480972|"~     The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI~     for investigating difference between normal or early fibrosis and advanced fibrosis.~   "
44010|NCT02480959|"~     The purpose of this study is to determine whether medial patellofemoral ligament~     reconstruction results in superior functional outcomes compared to medial retinacular~     plication surgery in cases of recurrent patellar instability.~   "
44011|NCT02480946|"~     Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent~     of patients don't respond to current treatments. MBS2320, the drug being tested in this~     trial, represents a new approach to treating RA, with the potential not only to reduce~     levels of inflammation but to also directly inhibit bone damage.The aim of this project is~     to test the safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change~     in the blood with dose, and to test the safety and compatibility of giving MBS2320 to~     patients with RA in combination with an existing treatment, methotrexate.~   "
44012|NCT02480933|"~     The aim of this study is to define silent breast cancer prevalence in both sexes and will be~     held by biopsies performed in imaging suspicious areas of the breast (ecography and~     mammography) in cadavers without known breast cancer.~   "
44013|NCT02480920|"~     This study will compose a national database of drug adherence and investigate the factors~     that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish~     Population.~   "
44014|NCT02480907|"~     The purpose of the Supporting Carers of Children and Adolescents with Eating Disorders in~     Austria (SUCCEAT) - study is to compare Workshop, Internet-based and Conventional Parental~     Support Groups for carers of chilren and adolescents between 10 and 18 years in a randomized~     controlled trial for the first time in Austria.~   "
44093|NCT02479867|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham~     Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets~     (Kahira Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration~     of each to healthy adults under fasting conditions.~   "
44015|NCT02480894|"~     This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male~     and female subjects.~        -  For the effect of maraviroc on the PK of BMS-626529 (the active moiety of BMS-663068),~          there is no formal hypothesis to be statistically tested. The purpose of this~          assessment is to estimate the effect of maraviroc on the pharmacokinetics (PK) of~          BMS-626529 when coadministered in healthy subjects.~        -  For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically~          tested is that BMS-663068 will not have a clinically significant effect on the PK of~          maraviroc when coadministered in healthy subjects.~   "
44016|NCT02480881|"~     This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI)~     study in healthy female subjects on oral contraceptives (OC). There is no formal research~     hypothesis to be statistically tested. It is expected that coadministration of BMS-663068~     with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or~     norethindrone (NE).~   "
44017|NCT02480855|"~     A vital question for society in general and primary health care in particular is early~     identification of persons at risk of sickness absence due to work-related stress. Even~     though both the individual and society can gain a lot from the prevention of absence, not~     the least since return to work is costly once a person is sick-listed. There is,~     surprisingly enough, no established method to do this. This project is a randomized~     controlled study of people with mental disorders and physical complaints consulting primary~     care. The purpose is to evaluate if a systematic use of early identification of work-related~     stress, combined with feedback at consultation, at the primary health care centers can~     prevent sickness absence among employed women and men with common mental disorders and~     subjective physical health complaints.~   "
44018|NCT02480842|"~     Introduction: physical therapy is essential in preventing motor and functional complications~     after breast cancer surgery. However, there is no prospective randomized study of different~     physiotherapy approaches in patients undergoing breast cancer surgery with immediate~     reconstruction. Objectives: to evaluate two physical therapy protocols in patients after~     breast cancer surgery with immediate reconstruction. A group with shoulder exercises with~     limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with~     limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM~     and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after~     surgery; assess motor function one week before the surgery on average, and 30 and 90 days~     after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery;~     associate incidence of seroma and dehiscence with preoperative risk factors and compare all~     variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two~     groups. Methods: women with breast cancer, who will be submitted to breast surgery (radical~     or conservative), followed by immediate reconstruction: alloplastic (tissue expander or~     breast implant) or oncoplastic (breast reduction or contralateral symmetrization) will be~     included. Patients that will be submitted to bilateral oncology surgery, reconstruction with~     autologous tissue or breast surgery without reconstruction will not be included. Patients~     will be recruited just after surgery scheduling and will undergo preoperative evaluation. At~     this moment, preoperative analysis will be conducted with personal data and medical history.~     Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery. All~     patients will receive standard physiotherapy treatment for women undergoing breast~     reconstruction from Physical Therapy Sector. The protocol consists of early exercise,~     limited to 90° of shoulder ROM, starting the day after the surgery and repeated 7 days after~     surgery. After 15 days of surgery, the patients will be randomized into two treatment~     protocols. One group will start to perform exercises with free shoulder ROM. Patients will~     be told only to limit the movement if they feel pain. The other group will keep shoulder~     exercises limited to 90° up to 30 days after surgery. At that moment (one month after~     surgery), they will also be allowed to move the shoulder with no restriction. The evaluation~     of the presence of dehiscence and seroma will occur by inspection and palpation. Shoulder~     ROM will be investigated through active goniometry of flexion, extension, adduction,~     abduction, internal rotation and external rotation. The pain will be assessed with the~     Verbal Numerical Scale from 0 to10 and upper limb function through the DASH (Disabilities of~     the Arm, Shoulder and Hand Questionnaire) questionnaire.~   "
44019|NCT02480829|"~     Two Phase Multicenter Study to Evaluate Safety and Efficacy of the Amphora OAB system for~     treatment of urgency and frequency with or without urge incontinence caused by an overactive~     bladder.~   "
44020|NCT02480816|"~     The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium,~     chloride, lithium and silicon are studied in humans. The aim of this assay was to determine~     whether the consumption of this water as part of the usual diet, reduces cardiometabolic~     risk factors in adult men and women.~   "
44021|NCT02480803|"~     Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are~     accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no~     comparative studies have been executed. The INVEST study is an open label randomised~     controlled trial with cost-effectiveness as primary outcome. Secondary outcomes will be~     quality of life, neurological impairments, among others.~   "
44022|NCT02480790|"~     Objectives of the study are: To estimate the incidence of venous thromboembolism (VTE) in a~     cohort of women with suspected ovarian cancer and evaluate changes in the coagulation system~     in case of benign or malignant disease. The impact of changes in the coagulation system on~     disease prognosis will be evaluated.~   "
44023|NCT02480777|"~     The primary purpose of this research study is to determine the safety of injecting ones own~     Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after~     a severe injury to the sciatic nerve has occurred.~   "
44024|NCT02480764|"~     The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil~     compared with valsartan in Chinese participants with essential hypertension.~   "
44025|NCT02480751|"~     The purpose of this study is to determine the recommended dose of the sustained-release form~     of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular~     disease/nephrosclerosis).~   "
44026|NCT02480738|"~     This study is to investigate the effectiveness of computerized cognitive training, and~     corresponding neural substrates through multimodal neuroimaging assessment, in the elderly~     with normal cognition, subjective cognitive impairment, and mild cognitive impairment.~   "
44027|NCT02480725|"~     The study hypothesis is that that the deleterious effect of prions on the brain may be~     mediated (at least partially) by activation of serine proteases involved in the coagulation~     system. If this is true, then measurement of the activity of the coagulation system may be a~     marker of disease onset (in at higher risk individuals such as E200K* carriers) and for~     disease progression or activity in affected individuals. In addition, modulation of the~     coagulation system activity may be a potential tool for therapeutic intervention.~      *E200K- E200K mutation (Glu to Lys substitution) in the prion protein gene~   "
44028|NCT02480712|"~     This study will evaluate the antiviral efficacy, safety and tolerability of sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) fixed dose combination (FDC) administered for 12 weeks in~     HCV treatment-naive and treatment-experienced (including treatment intolerant) adults with~     chronic HCV infection who are coinfected with HIV-1.~   "
44094|NCT02479854|"~     Comparative randomized, single dose, two-way crossover open-label study To investigate the~     bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg~     chewable tablets(Merck & Co. Inc. ), after a single oral dose administration of each to~     healthy adults under fasting conditions,~   "
44029|NCT02480699|"~     Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney~     functions. It is characterized by accumulation of solutes called uremic toxins. Uremic~     toxins levels are implicated in cardiovascular complications associated with CKD. Several~     protein-bound toxins have been implicated in the increased cardiovascular risk such as~     indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA).~     All clinical studies are performed with a single measurement at baseline assuming that the~     toxin levels are stable over time. The variability of uremic toxins level is not known.~     Furthermore, little is known concerning determinants of serum toxins level.~   "
44030|NCT02480686|"~     This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV~     genotype 1b treatment-experienced patients.~   "
44031|NCT02480673|"~     The objective of this study is to evaluate the effect of the administration of 25 g of chia~     per day, for 90 days on the biochemical components of the metabolic syndrome in subjects~     with this condition~   "
44032|NCT02480660|"~     Purpose: To understand the baseline knowledge on the transition of care to adult providers~     in hospitalized adolescent patients and to test if an educational intervention given during~     an inpatient stay in a medium size academic pediatric hospital affects perception of~     knowledge, attitudes and participation in transition planning.~      Primary Research Question: Will a video-based educational intervention in an academic~     pediatric hospital affect perception of knowledge, attitudes and participation in transition~     planning to adult oriented health care of the hospitalized adolescent?~      Secondary Research Question: What is the baseline experience of the hospitalized adolescent~     in key elements of transitioning to adult oriented health care?~   "
44033|NCT02480647|"~     Randomized clinical trial the use of levonorgestrel releasing intrauterine system.~      Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine~     system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the~     control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.~   "
44034|NCT02480634|"~     This study will give comparison of the bone pain remission and the adverse reaction of~     Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic~     acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial~     is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in~     treatment of non-small cell lung cancer bone metastasis'pain relief or not.~   "
44035|NCT02480621|"~     This study is a randomized controlled trial assessing pain control in ankle fractures~     repaired with open reduction and internal fixation. Patients are consented and enrolled~     pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine~     administered intra-operatively.~   "
44036|NCT02480608|"~     The study will test the tolerability and efficacy of the combination therapy~     Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic~     phase (CP1) newly diagnosted or failing interferon-based therapy.~   "
44037|NCT02480595|"~     The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,~     registry designed to collect on-label data in real world clinical settings on patients~     undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft~     System. Registry data will augment existing data from ongoing and prospective Aorfix™~     clinical trials for the purposes of publication, general product development and quality~     measures.~   "
44038|NCT02480582|"~     The current study will examine the effect of almond consumption (0.9g/kg dose) compared to~     an energy and weight matched comparator food or no food on measures of appetite control~     including appetite sensations, energy intake and food hedonics.~   "
44039|NCT02480569|"~     The investigators propose a single center prospective study that will assess two different~     strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing~     clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be~     measured with a non-side hole guide catheter (with the guide catheter both engaged and~     disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide~     catheter both engaged and disengaged from the coronary ostium) to determine, whether~     measurements obtained with an engaged side-hole guide catheter are more accurate as compared~     with those obtained with the engaged non-side hole catheter.~   "
44040|NCT02480556|"~     to compare the blood loss during caesarean section between two different methods of~     separating the placenta after fetal extraction, keeping in mind that most blood loss occurs~     after placental separation.~   "
44041|NCT02480543|"~     A randomized clinical trial to assess the effectiveness of same-day cervical preparation~     with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.~   "
44042|NCT02480530|"~     The purpose of this research study is to improve statin medication adherence among Veterans~     with coronary artery disease with poor adherence to medications. The investigators are~     testing if newer technology pill bottle devices linked with individual feedback and/or~     social incentive strategies can improve medication taking behavior.~   "
44043|NCT02480517|"~     The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled~     feasibility study of the safety of renal denervation in patients with stage I and II~     hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and~     have not been on any antihypertensive medications for at least six months.~   "
44044|NCT02480504|"~     A randomized clinical trial comparing the effect on weight reduction and cardiometabolic~     risk factors of intermittent energy restriction and a isocaloric continuous energy~     restriction in obese subjects.~   "
44045|NCT02480491|"~     Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for~     Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.~   "
44046|NCT02480478|"~     Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is~     is a pregnancy-specific liver disorder with onset mainly in the third trimester of~     pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and~     transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were~     found highly sensitive and specific biomarker to to differentiate ICP from other~     pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to~     determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.~   "
44048|NCT02480452|"~     The overall goal of this research proposal is the early prediction of the emergence of CVI~     and its characteristics on the basis of neuroimaging data.~      The different steps that will be taken to achieve this goal will be:~        1. To characterize CVI deficits in children;~        2. To correlate the CVI characteristics with their motor profiles;~        3. To characterize brain lesions in children with CVI;~        4. To link the motor profile, CVI profile and brain metrics of the children.~      Over the last 10 years, 488 children with and without CP have consulted at the CVI clinic in~     Leuven. All these children had a comprehensive visual perceptual assessment, cognitive~     evaluation and an ophthalmological assessment. Summarizing these data results in a~     quantitative visual perceptual profile for each individual patient. The goal is to~     prospectively extend this database to a number of 600 children. The project's primary~     objective is to relate the presence of CVI to the motor profiles of these children.~      Of these 488 children, 300 have an MRI available. The goal is to analyze the retrospective~     MRI data of this clinical group and to prospectively extend this database by reassuring~     newly registered children will receive MRI with DTI. This will allow the investigation of~     the correlation between the brain metrics and the CVI characteristics in a large cohort.~   "
44049|NCT02480439|"~     The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet~     compared with a TAK-648 oral solution, and to assess the effect of food on the~     bioavailability of a TAK-648 tablet in healthy participants.~   "
44050|NCT02480426|"~     To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography~     during transjugular intrahepatic portosystemic shunt (TIPS) creation.~   "
44051|NCT02480413|"~     The purpose of this prospective single center study is to investigate if a developed~     algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K.,~     Falkenberg, Germany). For this study 500 patients are required to collect anonymized data~     (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of~     80% during statistical analysis. The main hypothesis ist that the algorithm has a better~     accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).~   "
44052|NCT02480400|"~     To evaluate the effect of visit number, patient expectation, and rater expectation of the~     efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity~     in patients with MDD.~   "
44053|NCT02480387|"~     Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis~     C virus (HCV) infected adults that are co-infected with human immunodeficiency virus~     (HIV)-1and have HCV RNA < 6 x106 IU/mL~      Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment:~     treatment~   "
44054|NCT02480374|"~     This dose escalation study will determine a maximum tolerated dose and/or optimal biological~     dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.~   "
44055|NCT02480361|"~     Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is~     being accepted in the West as a treatment option for managing POI and various functional~     gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to~     evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients~     who underwent gastric surgery for a later large-scale study.~   "
44056|NCT02480348|"~     The purpose of this trial is to evaluate the clinical safety and efficacy of the~     Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in~     native coronary arteries with a reference vessel diameter (RVD) that allows use of stents~     between 2.25 and 3.50 mm in diameter.~   "
44057|NCT02480335|"~     The aim of the study is to investigate whether bosentan added to usual care improves~     arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium~     and large arteries corrected for blood pressure changes in patients with systemic sclerosis~     (SSc) with digital ulcers (DU). Patients will be randomized into a group with usual care and~     bosentan (n=20) or usual care only (n=20). PWV will be assessed at baseline, 3 months and 12~     months.~   "
44058|NCT02480322|"~     Background: Obesity is associated with multiple diseases. Bariatric surgery is the most~     effective therapy for severe obesity that cannot only reduce body weight but also~     obesity-associated morbidity.~      Objective: The metabolic alterations associated with obesity and respective changes after~     bariatric surgery are incompletely understood.~      Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based~     global, untargeted metabolomics strategy on human serum samples that were collected before~     and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy,~     proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also~     analyzed serum samples from normal-weight and less obesity obese subjects that were matched~     for 1-year postoperative BMI values of the surgical groups.~   "
44059|NCT02480309|"~     To determine the safety, feasibility and efficacy of the Multiple Model Probabilistic~     Predictive Control / Diabetes Assistant (MMPPC/DiAS) system in full day and night~     closed-loop control in adolescents and adults with type 1 diabetes. This will be addressed~     in two parts. There will be an initial 36 hour inpatient study with hourly plasma glucose~     monitoring and scheduled exercise and meals. If the system is shown to be safe, feasible and~     effective, the study will proceed to supervised hotel studies with remote monitoring to test~     system use over 3 days/2 nights.~   "
44060|NCT02480296|"~     The purpose of this study is to establish safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized,~     double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose~     study in healthy volunteers aged 18-55 years.~   "
44061|NCT02480283|"~     This study plans to evaluate the effects of chronic cannabis smoking on lung health by~     evaluating its effects on pulmonary health, lung physiology and alveolar macrophage~     function.~   "
44095|NCT02479841|"~     Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability,~     and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a~     major public health concern and has considerable impact on health and quality of life.~      For this study an evidence based self-management program is developed, the purpose of the~     study is to see if this self-management program, in collaboration between specialized health~     services and municipality health services, improves patients with COPD health-promoting~     competence, coping and quality of life, and reduces health service costs.The study has a RCT~     design.~   "
44062|NCT02480270|"~     This study plans to learn more about the effect of oral antibiotics for an outpatient~     pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung~     function, airway inflammation and quality of life. In this study subjects will perform~     pulmonary function tests, provide a sputum sample and complete a questionnaire at two~     separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will~     be asked to breathe in a salt water solution to help cough up sputum. The first sputum~     sample will be obtained at the first visit (within 48 hours of starting antibiotics).~     Pulmonary function testing and the questionnaire will also be completed at this time.~     Subjects will complete a two week course of oral antibiotics at home. During these two weeks~     subjects will be asked to write down the times antibiotics are taken and airway clearance~     (vest treatment) is performed. Within one week of completing the antibiotic course subjects~     will return to clinic for a second visit. At that time a sputum sample will be obtained~     again and if subjects are unable to cough up sputum they will again be asked to breathe in~     salt water solution to help cough up sputum. Pulmonary function testing and the~     questionnaire will also be completed at this second visit. Sputum samples will be tested for~     infections with bacteria and viruses. Sputum samples will also be used to measure markers of~     airway inflammation (swelling). The investigators hypothesize that the use of two weeks of~     oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in~     the amount of bacteria measured in sputum. Additionally the investigators hypothesize that~     treatment with antibiotics will lead to an improvement in lung function, a decrease in~     airway inflammation and an improvement in quality of life measurements.~   "
44063|NCT02480257|"~     The investigators aim to refine and pilot test an innovative group treatment model for~     adolescent depression and anxiety, Training for Awareness, Resilience and Action (TARA) in a~     sample of 14-18 year olds with depressive or anxious symptoms.~   "
44064|NCT02480244|"~     This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally~     appropriate behavioral intervention to reduce obesity levels and ultimately the risk of~     developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm~     ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the~     work-site on diabetes, diet and physical activity and optional supplemental sessions in the~     evening and weekends. The investigators will adopt the intent-to-treat principle for the~     primary analysis. Individuals on control ranches will receive no health educational~     instruction. The primary outcome is BMI. The investigators hypothesize that intervention~     ranches will achieve significant improvement in obesity and diabetes risk factors as~     compared to control ranches.~   "
44065|NCT02480231|"~     Prospective randomized clinical trial comparing two methods of intra-operative tensioning of~     retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of~     abnormal bladder function. Secondary outcomes include validated quality of life scores,~     physical exam findings, and rates of immediate post operative voiding dysfunction.~   "
44066|NCT02480218|"~     Breast cancer is the most frequently diagnosed cancer in women with the majority receiving~     an endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and~     improve survival but given the aging population and increased survivorship, there are~     growing concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A~     critical unanswered question is whether there are differences in cognitive decline between~     the two classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and~     aromatase inhibitors (letrozole and anastrozole), in older women at greater risk of hormone~     receptor breast cancer and cognitive decline. Before a large multicentre observational study~     can be undertaken the investigators are proposing a feasibility study to establish metrics~     on participation, retention and adherence rates and parameter estimates to inform sample~     size calculation required to detect cognitive differences between the two ET classes. A~     convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage~     disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at~     baseline and after one year.~   "
44067|NCT02480205|"~     There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is~     preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal~     continuous positive airway pressure (CPAP) or nasal intermittent positive pressure~     ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed~     end-expiratory pressure. The synchronization in conventional mode is very difficult to~     obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is~     fixed. Considering that preterm infants are more likely to develop atelectasis, an active~     and ongoing management of the PEEP is very important to prevent de-recruitment.~      A new respiratory support system (NeuroPAP) was developed to address these issues~     (synchronization problems and control the PEEP). It uses the electrical activity of the~     diaphragm (EDI) to control the ventilator assist continuously, both during inspiration~     (principle of NAVA mode) and also during expiration (based on tonic Edi level).~   "
44068|NCT02480192|"~     Women going through the menopausal transition often experience adverse physical changes~     (e.g., hot flashes/night sweats, sleep difficulties, sexual concerns) in addition to~     emotional difficulties (e.g., depression, anxiety) that can significantly impact functioning~     and overall quality of life. To date, hormone therapy (HT) has been the most commonly used~     treatment to relieve symptoms of menopause. However, reports have questioned the safety of~     HT long-term (e.g., risk of heart attacks, strokes, cancer) in some women.~     Cognitive-behavioural therapy (CBT), has been proposed as a low-risk treatment for~     menopausal symptoms and received some initial support. The investigators developed a~     comprehensive non-pharmacological, CBT based treatment program for menopausal symptoms,~     published the treatment manual, and have initial evidence supporting its effectiveness with~     the investigators' published pilot data. The investigators' goal is to conduct a large~     randomized controlled trial of Cognitive Behavioural Group Therapy (CBGT) for the~     improvement of menopausal symptoms. The investigators hypothesize that participants will~     experience fewer and less intense/disruptive hot flashes/night sweats, reduced depression~     and anxiety and improvement in sleep difficulties, sexual concerns, and overall quality of~     life. The investigators also predict that these benefits will be maintained at follow up and~     there will be high satisfaction associated with the program by participants.~   "
44069|NCT02480179|"~     The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain~     modulation of appetite and food craving in a randomized controlled study. The H.E.G. will~     serve as the neurofeedback modality while the functional brain imaging will enable~     assessment and hopefully validation of changes brain activity related to food craving and~     self-control. H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is~     based on changes in blood oxygenation level as a result of regional brain activation. The~     unique advantage of this technology regarding our enterprise is that it inheritably samples~     the two brain areas that are in our focus of interest: the superior orbito-frontal cortex~     (OFC) which Involved in self-control and reward processing, and the anterior cingulate~     cortex (ACC) which processes cognitive and emotional information. The investigators will~     combine HRV (Heart rate variability) biofeedback, which is a well-established treatment form~     in the investigators therapeutic sessions and will correlate functional neuroimaging with~     behavioral, anthropometric and laboratory data.~      The intervention name is: Measurements of blood flow changes within the brain and online~     visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red~     sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio~     Trace Plus software made by MindMedia, The Netherlands.~      Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control~     of blood flow to frontal brain areas, as a marker of brain activity in these areas~   "
44070|NCT02480166|"~     The primary objectives of this study are to describe the efficacy of:~        1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6~        2. 12-week treatment of SOF/LED for all other HCV-6 populations~   "
44071|NCT02480153|"~     The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab~     in combination with methotrexate in subjects with moderately to severly active rheumatoid~     arthritis who have had an inadequate response to methotrexate.~   "
44072|NCT02480140|"~     Emerging research suggests the use of self-regulation (SR) strategies at improving~     functional regain in patients with brain injury. SR is proposed to produce an added effect~     to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the~     efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with~     subacute stroke. It was hypothesized that participants receiving the combined treatment (SR~     and CIMT) would have a better functional regain.~   "
44073|NCT02480127|"~     Repeated implantation failure (RIF) is determined when failure of implantation occurred~     during at least three consecutive IVF attempts while at least one high-grade embryo was~     transferred in each cycle. Several methods have been suggested to improve the implantation~     rate in RIF patients. One of the most promising methods is local injury to the endometrium.~     It has been reported that the rates of implantation, clinical pregnancy, and live birth~     reach more than double in RIF patients with local endometrial injury than patients without~     it. The population of this study included all infertile couples attending the Royan~     Institute, who have at least three consecutive cycles of ART failure. Also this study is~     phase 3 randomized clinical trial. Based on the average menstrual cycle 30-28 days,~     endometrial and blood samples were collected from two groups of patients on day 21 of luteal~     phase of their spontaneous menstrual cycle. The intervention, but not the control group~     underwent prior biopsy treatment in follicular phase on days 8 or/and 11 to 13 of that same~     cycle but in these days blood sample in both groups were collected. To investigate the~     impact of local endometrial injury in increasing the rate of pregnancy in ART - treated RIF~     patients, the investigators will examine the changes of immunological factors involved in~     the implantation including some cytokines, growth factors ( in serum and endometrial~     biopsies) and the expression of TLRs and HOX genes ( in endometrial biopsies) obtained from~     both groups.~   "
44074|NCT02480114|"~     This randomized phase III trial studies how well gabapentin plus standard of care work~     compares to standard of care without Gabapentin in preventing inflammation of the mucous~     membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing~     primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and~     neck may cause a burn involving the inside of the mouth, throat, and nasal passages,~     resulting in pain. Gabapentin may help prevent (or minimize) pain associated with~     radiation-induced mucositis in patients with head and neck cancer.~   "
44075|NCT02480101|"~     This is a single centre phase I, double-blind placebo-controlled study to assess~     reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9)~     influenza vaccine in healthy male and female adults, 18 through 49 years of age .~   "
44076|NCT02480088|"~     Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain~     control, however, its use inevitably increases the incidence of postoperative nausea and~     vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the~     prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy~     for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of~     5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This~     study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients~     using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic~     efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during~     postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be~     evaluated in all patients.~   "
44077|NCT02480075|"~     The purpose of this study is to (a) evaluate the treatment approaches and changes in~     treatment regimens utilized by clinicians when genetic testing is performed in the clinic;~     and (b) create a patient data registry to identify genetic factors that influence treatment~     outcomes in pain management.~   "
44096|NCT02479828|"~     This study evaluates the effect of fascia iliaca compartment block (FICB) in the management~     of acute post -surgical pain in hip fracture patients and in the appearance of chronic post~     -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain~     in Greek.~      Half of the patients will not receive fascia iliaca compartment block.~   "
44107|NCT02479685|"~     This prospective randomized pilot study is aimed to verify if the operative time of a~     standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment~     of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic~     loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD~     (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic~     morcellator.~   "
44078|NCT02480062|"~     Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low~     detection rates, inadequate use of evidence based interventions and low adherence with these~     interventions. Primary health care is the appropriate setting for improving the prevention~     and management of these chronic conditions. The investigators will develop and evaluate an~     innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a~     patient health profile, decision support for clinical care, monitoring and feedback for use~     in Indian Community Health Centers (CHCs). The investigators will conduct this research~     following the steps proposed by the medical research council (MRC) for evaluation of complex~     interventions. Technical development of m-WELLCARE will be conducted, user acceptability~     appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two~     states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health~     care received and changes in risk factors achieved will be evaluated.~   "
44079|NCT02480049|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for~     Novartis Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global~     Napi Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral~     dose administration of each to healthy adults under fasting conditions.~   "
44080|NCT02480036|"~     The primary objective is to evaluate the tolerability (side effects) of the intraoperative~     radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord~     damage, and pathological fracture), and the secondary objective is to evaluate the~     effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor~     response).~   "
44081|NCT02480023|"~     BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams~     Maternity hospital.~   "
44082|NCT02480010|"~     This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in~     participants with hormone-refractory prostate cancer who have had no previous chemotherapy.~     Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and~     the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50~     participants may enter either cohort, for a total enrollment between 46 and 73 participants~     across 9 study centers.~   "
44083|NCT02479997|"~     This study aimed to compare detection rate between dual sentinel node staining method using~     mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.~      To identify the first lymph node(s) along the lymphatic drainage pathway from the primary~     tumor in the breast cancer using RI only has several disadvantages such as invisibility,~     interference. As ICG can be visualized with a fluorescence imaging system, we expects dual~     sentinel lymph node staining method had better outcomes.~   "
44084|NCT02479984|"~     The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients~     with potentially resectable pancreatobiliary cancer.~   "
44085|NCT02479971|"~     A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve~     gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups:~     those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those~     undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2).~     Postoperative pain and C reactive protein will be investigated 24 hours after surgery.~   "
44086|NCT02479958|"~     Despite of the decline of dental caries, this disease is still common in polarized groups~     affecting children. Therefore, the aim of this randomized blind in vivo study was to compare~     the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty~     two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin~     lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and~     resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy~     (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and~     RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The~     patients were submitted to initial clinical and radiographic examination and demographic~     features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and~     radiographic follow up at 6 and 12 months after the treatments. The carious dentin was~     collected before and after each treatment and the number of Streptococcus mutans,~     Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and~     total bacteria were established by quantitative PCR.~   "
44087|NCT02479945|"~     The investigators will compare tumor marker levels, including PSA, in samples taken from a~     peripheral upper limb vein and the internal iliac veins. These will be collected from~     patients who are scheduled for prostatectomy as part of their standard of care for prostate~     cancer. A selective internal iliac vein sampling procedure will be performed in~     Interventional Radiology. Venous samples will be correlated with prostatectomy specimens.~     The aim is to predict the side of the prostate containing tumor.~   "
44088|NCT02479932|"~     The aim of study is to compare skin-to-delivery time and postoperative morbidity between~     extraperitoneal cesarean and transpirational cesarean.~   "
44089|NCT02479919|"~     The purpose of the study is to test a new treatment of social cognition deficits in patients~     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation~     (theta-burst). The study will also identify clinical, psychomotor and cognitive variables~     that are the most sensitive to treatment, and estimate the most sensitive treatment target~     between patients.~   "
44090|NCT02479906|"~     The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep~     TMS (DTMS) for the treatment of PTSD.~   "
44091|NCT02479893|"~     Given the limited existing data regarding the advantages and limitations of the existing~     techniques in the removal of colonic polyps the investigators designed a prospective study~     in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete~     removal of colonic polyps of the left colon up to a diameter of 0.8cm.~   "
44092|NCT02479880|"~     To characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label~     tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This~     includes prospectively evaluating and comparing the bone mineral density (BMD) change~     between CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in~     European treatment centers who are assigned to one of two schedules for renal and bone~     laboratory monitoring and BMD measurement.~   "
44097|NCT02479815|"~     The purpose of the study is to assess the safety of iron supplementation in MNPs. A~     quasi-experimental matched-control cluster design will be used in, purposely selected, 18~     intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and~     People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from~     intervention and non-intervention clusters will be enrolled and followed longitudinally for~     12 months. Morbidity data using standardized questionnaire, will be collected at baseline,~     and every two weeks for a period of 12 months~      Research questions to be answered in this study are:~        1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young~          children with or without iron deficiency safe, as assessed by their morbidity from~          infectious diseases?~        2. What is the impact of the provision of low dose iron-containing Micronutrient Powders~          (MNPs) to young children on (body) iron status? Morbidity data will be collected at~          baseline, and every two weeks in the same cohort of children.~      Body iron status will be assessed at baseline and endline as measured by serum ferritin,~     serum transferrin receptor, hemoglobin concentration, CRP and AGP.~      In addition data on the following outcomes will be collected in these children:~        1. Anthropometry (weight, height, MUAC) every 4 months~        2. Breastfeeding status and consumption of processed complementary food portions in the~          previous week -every 4 months~        3. Compliance to study intervention.~   "
44098|NCT02479802|"~     Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5%~     albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic~     Lateral Sclerosis (ALS).~   "
44099|NCT02479789|"~     Intra operative Nerve Monitoring ( IONM ) is rapidly becoming the standard of care for~     thyroid surgery to prevent injury to the recurrent laryngeal nerve. However the laryngo~     tracheal reflexes need to be adequately suppressed to permit proper utilization of intra~     operative nerve monitoring. Increasing the depth of anesthesia to achieve this often leads~     to side effects. Intravenous lidocaine infusion has been shown to be effective in blunting~     these reflexes. The planned study intends to look at the efficacy of intravenous lidocaine~     infusion in decreasing the amount of anesthesia medications needed to suppress the reflexes.~     Also the study looks at the analgesic and anti emetic properties of intravenous lidocaine~     infusion post operatively by measuring these outcomes.~      The study is designed as a double blinded randomized controlled trial with 30 subjects in~     the group who will receive intravenous lidocaine during surgery and 30 subjects in the group~     who will receive placebo. Blunting of the laryngo tracheal reflexes intra operatively will~     be recorded as the primary outcome. The amount of anesthesia medications, the post operative~     patient comfort level, pain control, usage of narcotic pain medications, nausea, vomiting~     will be recorded as secondary outcomes.~   "
44100|NCT02479776|"~     The bone marrow mononuclear cell fraction has been used as therapy after myocardial~     infarction and in dilated cardiomyopathy in adults. The absence of adult co-morbidities may~     enhance the potential effectiveness of pediatric stem cells.This study is a randomized,~     crossover, placebo controlled pilot study to primarily determine the safety and feasibility~     of stem cell intracoronary therapy in children. Secondary end points are MRI measurements~     and NTproBNP.~      Ten children (mean age 7.2 years, range 2.2-14.1, 6 male) with dilated cardiomyopathy (NYHA/~     Ross Classification 2-4) will be recruited. Bone marrow aspiration MRI and cell injection~     are performed under the same anaesthetic. Patients will be crossed over at 6 months.~   "
44101|NCT02479763|"~     In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%.~     This stems from the prevalence of trainee operators coupled with the non-specific nature of~     loss-of-resistance. In the current randomized trial, we will set out to compare conventional~     and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research~     hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease~     the failure rate of thoracic epidural blocks.~   "
44102|NCT02479750|"~     This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold~     symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy~     volunteers. Half of participants will receive ColdZyme® mouth spray while the other half~     will receive placebo.~   "
44103|NCT02479737|"~     Postoperative bleeding is a common consequence after heart surgery which can significantly~     impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. When bleeding occurs, reliable~     postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest~     tubes is imperative to facilitate pulmonary re-expansion and mediastinal decompression as~     the patient recovers. When postoperative blood evacuation is inadequate, retained blood~     complications can result (herein described as the Retained Blood Complications (RBC). RBC is~     the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed~     and may necessitate drainage in the acute or sub-acute setting. The need for treatment and~     interventions for these conditions represents an impediment to patient recovery and involves~     both resource and economic consumption for a heart program and the healthcare system at~     large.~      Clinically, Retained Blood Complications (RBC) can be recognized acutely or subacutely. When~     it presents acutely, it is usually fresh thrombus around the heart or lungs presenting as~     tamponade or hemothorax. When it presents subacutely, it results in bloody pleural or~     pericardial effusions. These effusions are often driven by the breakdown of remaining~     thrombus. Once RBC occurs, subsequent procedures may be needed to remedy it.~      A recent review of the literature indicated that additional procedures for RBC are~     demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively~     collected United States Nationwide Inpatient Sample (NIS) data from 2010, RBC could be~     demonstrated in 17% of patients. In this analysis, mortality was doubled from 4% to 8%,~     length of stay was increased by 5 days, and average costs were 55% higher. Patients with~     RBC, therefore, represent an increased at risk population for complications and costs.~      Postoperative obstruction of conventional chest tubes with blood and other fibrinous~     material in the setting of postoperative bleeding contributes to RBC. (Shalli) In a recent~     study of postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients~     were found to have evidence of chest tube obstruction . Active Clearance with PleuraFlow has~     been shown to prevent chest tube clogging, and reduce RBC.~   "
44104|NCT02479724|"~     Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and~     Intra-Arterial Catheters in ICU Patients~   "
44105|NCT02479711|"~     The aim of the present study is to evaluate the clinical performance of EQUİA restoration~     material in Class II cavities comparing with a resin-based composite / dentin bonding~     system.~   "
44106|NCT02479698|"~     The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes~     (CTLs) can help to control BK viral infection and JC viral infection. Researchers also want~     to learn about the safety of giving CTLs to patients with BK and/or JC infection.~      CTLs are made from donated blood cells that are grown in the laboratory and are designed to~     kill viruses that can cause infections.~   "
44134|NCT02479334|"~     This study aims to investigate the effect of spices on gene expression of pathways~     associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial~     phase in healthy human subjects.~   "
44108|NCT02479672|"~     This is a prospective randomized clinical study to be performed in adult patients ages 18~     and older who are undergoing surgical procedures requiring endotracheal intubation. Adult~     patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and~     the time to intubation will be compared and recorded. Patients in both treatment arms will~     receive manual inline stabilization. The study hypothesis is that the time to endotracheal~     intubation will be decreased in the VividTrac® video laryngoscope group when compared to~     direct laryngoscopy.~   "
44109|NCT02479659|"~     This randomized evaluation measured the impact of two levels of support for the integration~     of infant and postpartum maternal HIV testing with routine immunization services in Southern~     Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose~     diphtheria, pertussis, and tetanus (DPT1) vaccines.~   "
44110|NCT02479646|"~     This is a single center, double-blind, randomized, comparative pharmacokinetic and~     pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy~     Volunteers.~   "
44111|NCT02479633|"~     Background: The aim of present clinical study was to evaluate the predictive values of~     baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and~     inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of~     single gingival recession (GR) defects treated with coronally advanced flap and connective~     tissue graft technique (CAF+CTG).~      Material and Methods: The study group included 65 females and 57 males, aged between 20 and~     42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or~     smaller to the buccal CAL , located at upper and lower incisors and canines were treated~     with CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC~     after 6 months.~   "
44112|NCT02479620|"~     This is a prospective, multi-center, randomized pilot study to document the effects of~     adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions~     below the knee in symptomatic patients with critical limb ischemia (CLI).~   "
44113|NCT02479607|"~     The purpose of this study is to evaluate the effects of an interactive Information and~     Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients~     treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical~     management will be improved and costs reduced and safe and participatory care promoted, when~     patients report symptoms in an application which provides self-care advice and instant~     access to professionals.~   "
44114|NCT02479594|"~     In a randomized controlled study design, n = 58 treatments of patients with depression were~     to be conducted under a feedback-condition, in which the therapist would receive feedback~     five times within 20 treatment sessions. The competence-feedback includes detailed feedback~     about 14 different aspects of therapist behavior. The control group includes n = 58 further~     treatments within which therapists do not receive any competence-feedback (treatment as~     usual; TAU).~   "
44115|NCT02479581|"~     This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional~     postoperative care in patients with heart valve disease undergoing cardiac surgery with~     cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other~     half will under the conventional postoperative care.~   "
44116|NCT02479568|"~     The primary aim is to examine both the acute and chronic effects of hesperidin consumption~     from 100% Florida orange juice in various doses on functional and systemic markers~     associated with cardiovascular disease (CVD) risks.~   "
44117|NCT02479555|"~     This is a prospective, multi-center, randomized pilot study to document the effects of~     adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in~     symptomatic patients with critical limb ischemia (CLI).~   "
44118|NCT02479542|"~     The worldwide prevalence of open wounds is estimated to be approximately 200 million per~     year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an~     open wound cavity, has been clinically demonstrated in developed nations to speed the~     healing time of open wounds by a factor of two or more, and to aid in complete recovery with~     less scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings~     due to cost, bulk, and requirement for consistent electricity. This study aims to follow up~     prior clinical studies that have established the safety and efficacy of simplified NPWT, by~     assessing changes in wound closure time and wound contraction rate when simplified NPWT is~     used in a limited-resource setting.~   "
44119|NCT02479529|"~     After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound~     hypotension associated with a decrease in systemic vascular resistance. The care of this~     disease is based on the intravenous administration of a vasopressor, usually norepinephrine.~     During the recovery phase, weaning of norepinephrine, is an important step in which any lack~     of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.~   "
44120|NCT02479516|"~     The investigators are adopting an intervention which has been tested in Canada to the~     Philippine setting. The program will be called Community Health Assessment Program in the~     Philippines (CHAPP). The main goal of CHAPP is to decrease diabetes and its complications by~     implementing a community-based program.~      The CHAPP intervention will be modified so that it will be applicable to the Philippine~     setting and other Low and Middle Income Countries. The initial plan for the program is that~     trained volunteers or health workers will be running the CHAPP sessions 2-hours a week in a~     community location for residents in the community. During the CHAPP session, volunteers will~     administer a questionnaire and do basic measures (assessing the weight, height, blood~     pressure, waist measurement). The questions can be entered into a laptop/tablet/cell-phone~     or written into a paper questionnaire depending on the abilities of the volunteer to use~     computers. Based on the data gathered, the volunteers will identify residents who have a~     high risk of developing diabetes (including long term complications of diabetes such as~     hypertension), educate them regarding what to do to avoid having diabetes (by doing~     exercise, improving their diet, and avoiding unhealthy lifestyle), and refer them to local~     health care when needed. Residents who have high risk of developing diabetes will be~     referred to have their blood sugar checked. Residents who have diabetes or complications of~     diabetes will be checked to see if they are being treated properly; if not they will be~     referred to the local doctor for treatment and medication. All the information regarding the~     CHAPP sessions will be sent to the Local Public Health Office or other designated local~     health centre so that they will be able to educate, monitor, and attend to residents who~     have diabetes or who have high risk of developing diabetes.~   "
44121|NCT02479503|"~     The study focuses on the antibiotic prophylaxis use in adult heart transplantation in~     France.~   "
44148|NCT02479152|"~     The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to~     investigate haemodynamics generated by the standard mechanical external chest compression~     device (LUCAS™ 2) compared to a new version generating chest compressions and active~     decompression above the initial starting position of the suction cup (LUCAS™ 2AD).~   "
44149|NCT02479139|"~     The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment~     of primary axillary hyperhidrosis.~   "
44122|NCT02479490|"~     This is a multicenter prospective study that includes all patients with metastatic Renal~     Cell Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers.~      Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil~     in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice~     daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs~     will be self-administered orally, continuously from Day 1 (Visit 2) until progression of~     disease, unacceptable toxicity, death or discontinuation for any other reason.~      A treatment cycle consists of 28 days.~   "
44123|NCT02479477|"~     The quality of life and daily activities can be affected by muscleskeletal pain and one of~     the forms of assessment is through the SF-36 questionnaire. The investigators know that the~     working kinesitherapy is a way to improve the quality of life.~   "
44124|NCT02479464|"~     The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm~     that has been designed to improve the effectiveness and safety of antidepressant medications~     by providing guidance in medication selection and appropriate dosing. This algorithm has~     been incorporated into a new genotyping interpretative report. This report is now available~     from AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four~     informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome~     P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor~     gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo~     clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.~   "
44125|NCT02479451|"~     This clinical trial examines whether nasal theophylline administration can improve olfaction~     and nutrition in hemodialysis patients.~   "
44126|NCT02479438|"~     The purpose of this registry is to evaluate information to determine which operations and~     treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus~     or digestive tract are providing the most benefit including the long-term effects of~     treatment (or no treatment) and the progression of the disease over time.~   "
44127|NCT02479425|"~     Several studies were searched the preventive measures of bed sores. Although repositioning~     is the mainstay in most preventive measures, there is no evidence to recommend specific~     turning regimen.~      The aim of this study is to comparative the impact of the two points repositioning in~     lateral lying position on the right and left versus the traditional three points~     repositioning on the right, back, and left in the occurrence of bed sores.~      This study was conducted on 150 patients admitted to the critical care department of~     Alexandria Main University Hospital after obtaining an informed consent from their~     relatives.~      The investigators excluded patients who: have active or healed bed sores.~      Patients were randomly divided into two groups by allocated randomization:~        -  Group 1: traditional three points rotation.~        -  Group 2: two points rotation.~   "
44128|NCT02479412|"~     This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled,~     multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once~     daily by inhalation, in patients with mild to moderate asthma.~   "
44129|NCT02479399|"~     The objective of this survey is to confirm the safety of Suglat Tablets~   "
44130|NCT02479386|"~     This study seeks to better characterize relationships between visual function and the~     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration~     (AMD). The study is also intended to generate new information on the relationship between~     genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study~     enrolling patients with GA secondary to AMD. The study visits are scheduled to occur every 6~     months. The anticipated duration of the study is up to 48 months. There is a planned interim~     analysis around the 2 year time window for the study.~   "
44131|NCT02479373|"~     This research is being done to see if resistance exercise (RE) is safe and has a positive~     effect on children and young adults with juvenile idiopathic arthritis (JIA).~      JIA is an inflammatory autoimmune disease that can cause severe impairment and disability.~     JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can~     also have negative effects on growth and development, strength, and ability to function. RE~     is performing movements in a slow and controlled fashion (i.e., no speeding up or using~     force in the lifting and lowering of the weight) to lessen force on the joints and tissues.~     This study will be using Ren-Ex exercise equipment to perform RE.~      Currently the American College of Rheumatology recommends exercise for patients with~     arthritis. This exercise includes range of motion exercise to protect joint mobility as well~     as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and~     fitness. However, a recent study showed no major differences in functionality or quality of~     life between patients who performed AE and those who did not perform AE. There is a need for~     more data on the impact of RE on children with JIA. Children and young adults aged 10 to 21~     with juvenile idiopathic arthritis may join.~   "
44132|NCT02479360|"~     Neurofibromatosis 1 (NF1) is a common inherited condition that affects the skin, bone and~     nervous system. The complications of NF1 are widespread and can lead to varied difficulties~     dependent on the location of neurofibromas and their secondary complications. At present~     evaluation of the effect of treatments in NF1 is based on a clinician's neurological~     assessment, magnetic resonance imaging and positron emission tomography but it is apparent~     that imaging results do not always link with clinical and functional changes in an~     individual. This study aims to evaluate the reliability (stability) of a range of functional~     standardised outcome measures in adults with NF1.~   "
44133|NCT02479347|"~     The development of surgical site infections (SSI) in clean-contaminated surgery is regarded~     as being preventable. Known to be effective in the prevention of surgical site infection are~     the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic~     prophylaxis where indicated, and certainly the preparation of the skin at the incision site,~     since the patient's skin is the principal source of bacterial contamination of the wound.~     This study aims to investigate the efficacy in prevention of surgical site infection in~     clean surgery, using two different standardized methods of skin preparation: povidone-iodine~     10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70%~     isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a~     single-center study will enroll a homogeneous population, undergoing breast cancer surgery.~   "
44135|NCT02479321|"~     Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per~     100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory~     complications during and after surgery partly explain this high morbidity and mortality.~     Most patients are frail and with multicomorbidity. Perioperative Goal-Directed Hemodynamic~     Therapy (PGDT) based on noninvasive continuous monitoring of blood pressure, heart rate,~     oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index can~     reduce perioperative complications and improve survival. The objective of our study is to~     assess the efficacy of a goal-directed hemodynamic therapy during the perioperative period~     in reducing intraoperative complications, especially hemodynamic instability, postoperative~     complications and 1-year survival. Patients and Methods: non-randomized intervention study~     with a historical control and 1-year follow-up. Patients older than 64 years with~     non-traumatic hip fracture requiring surgical intervention. In the control group blood~     pressure, heart rate, oxygen saturation and clinical situation besides respiratory~     parameters were recorded at intervals of 15 minutes. In the intervention group PGDT based on~     noninvasive monitoring will be performed. The main outcome will be the percentage of~     patients with hemodynamic instability complications and the average of complications per~     patient. Secondary outcomes: intraoperative complications, postoperative complications and~     survival at 12 months of surgery.~   "
44136|NCT02479308|"~     This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as~     well as evaluate the safety and tolerability of ALKS 5461.~   "
44137|NCT02479295|"~     This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal~     dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in~     favor of straight catheters. The effects of straight versus coiled peritoneal dialysis~     catheters, however, are unclear. The investigators design an adequately powered randomized~     controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters.~     The primary objective is to assess whether straight peritoneal dialysis catheters can reduce~     the risk of catheter dysfunction that requires intervention. The investigators estimate that~     they would need to enroll 132 incident peritoneal dialysis patients in each group for the~     study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of~     catheter dysfunction requiring intervention.~   "
44138|NCT02479282|"~     Effect of natural cesarean section in comparison to traditional cesarean section on maternal~     and fetal recovery.~   "
44139|NCT02479269|"~     The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on~     serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with~     cardiovascular disease. Patients were divided randomly into two groups: control and~     experimental aerobic group. This study was done with two - stage blood sampling: at the~     beginning and at the end of the treatment phase. All subjects were requested to avoid any~     exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C -~     reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein.~     Blood samples for subsequent measurements were frozen immediately and transported to the~     Hormone Laboratory for serum separation. The experimental group did the aerobic exercise~     programs for 8 weeks for 3 sessions per week and the control group did not receive any~     training. After completion of training, the final blood samplings were performed. Exercise~     intensity according to the heart rate remained stable until the last week. Brain Natriuretic~     Peptide and C - reactive protein levels were measured by ELISA tests. All statistical~     analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05~   "
44140|NCT02479256|"~     Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with~     PCOS.~   "
44141|NCT02479243|"~     Collateral circulation supports brain tissues to maintain blood perfusion in cerebral~     ischemic stroke and are of great benefit for a better outcome. A non-invasive approach~     relative to currently widely used digital subtraction angiography (DSA) is needed. ASL~     (arterial spin labeling) is a novel perfusion method without contrast agent injection and~     features both temporal and cerebral blood flow(CBF) information. The investigators applied~     multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL)~     MRI and subtraction images were obtained to evaluate the collateral robustness and~     quantitatively assess the collateral perfusion in patients with unilateral middle cerebral~     artery atherosclerotic stenosis and the ability to predict future stroke recurrence.~   "
44142|NCT02479230|"~     This pilot clinical trial studies the safety of a dendritic cell vaccine when given with~     gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the~     breast and local lymph nodes to other organs in the body. The vaccine is made up of natural~     cells found in the blood, called dendritic cells, and peptides, or small fragments of~     protein which are loaded onto the dendritic cells. This combination may help activate the~     immune system against stromal cells, which are cells that help cancer cells survive in the~     body. Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to~     help shrink the tumor and control cells that may interfere with the activity of the vaccine.~     Interfering with the stromal cells that help support the growth of cancer cells may lead to~     the death of the cancer cells.~   "
44143|NCT02479217|"~     The primary objective of this study is to observe safety and tolerability of Xeloda as used~     in medical practice, alone and in combination with docetaxel.~   "
44144|NCT02479204|"~     The aim of the study is to investigate the safety of the concomitant administration of~     ACT-334441 with cardiovascular drugs.~   "
44145|NCT02479191|"~     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center~     post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform~     when used in the endovascular treatment of female patients.~   "
44146|NCT02479178|"~     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients~     with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the~     biliary tree and squamous cell carcinoma of the head and neck.~      Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.~   "
44147|NCT02479165|"~     The aim of this randomized controlled study is to shed light on the analgesic properties and~     side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.~   "
44185|NCT02478671|"~     Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and~     pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.~   "
44150|NCT02479126|"~     The primary objective of this research project is to describe the characteristics,~     diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who~     received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6~     Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West~     Virginia) for up to 5 years.~   "
44151|NCT02479113|"~     Besides maternal hyperglycemia, a strong link between maternal pregravid weight/maternal~     triglyceride(Tg) levels and fetal growth/childhood obesity/metabolic syndrome in offspring~     has been demonstrated in largely Caucasian populations. This study aims to explore the link~     between maternal hypertriglyceridemia and offspring health in Asians.~   "
44152|NCT02479100|"~     The aim of this study is to determine if the addition of Contrast Enhanced Spectral~     Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient~     management - discharge, follow-up, surgery or treatment - being made sooner than it would if~     the patient had followed the standard course of investigations and review.~      The investigators also intend to compare CESM with MRI. Images and pathology results from~     patients who undergo both CESM ans MRI will be reviewed retrospectively for detection of~     abnormality and identification of type of abnormality, i.e. is it a cancer or not?~   "
44153|NCT02479087|"~     The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot)~     in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with~     inhibitors, including patients at high risk of failure.~   "
44154|NCT02479074|"~     In this study the investigators wish to explore the difference in 24 hr. cough counts~     measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks~     treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30~     ppb at screening.~   "
44155|NCT02479061|"~     The purpose of this observational study is to determine the proportion of patients with a~     score greater than 3/10 to the questionnaire PALLIA-10.~      This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at~     helping the providers of care to identify patients who would require palliative cares.~      According to the notice of the questionnaire, patients with a score greater than 3 would be~     taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire,~     it seems that a large majority of patients would have a score greater than 3 in the context~     of anti cancer centers.~      To date, palliative teams are not designed to take in charge such an amount of patients.~   "
44156|NCT02479048|"~     The primary goal is to characterize the acute effects of avocado intake on glycemic and~     satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary~     goal is to investigate risk factors for cardio-metabolic disease.~   "
44157|NCT02479035|"~     The purpose of this study is to investigate the relative bioavailability and~     absorption/kinetic profile of red raspberry polyphenols consumed with a meal and further to~     determine the relationship of these findings on meal-associated metabolic- oxidative- and~     inflammatory- responses in relatively insulin sensitive and insulin resistant individuals.~   "
44158|NCT02479022|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy~     subjects.~   "
44159|NCT02479009|"~     Aim:~      The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in~     diagnosing displacement of acute scaphoid waist fractures.~      Primary null hypothesis:~      Fluoroscopy has comparable sensitivity, specificity, accuracy, positive and negative~     predictive values compared with computed tomography for the diagnosis of displacement of~     acute scaphoid waist fractures.~      Secondary null hypothesis:~      All fractures diagnosed as non-displaced and treated without surgery are healed on~     radiographs and discharged from care within 6 months of injury.~   "
44160|NCT02478996|"~     This study will evaluate, if an intensive individually adaptated training program via online~     supervision during neoadjuvant therapy will improve lung function and reduce pulmonary~     complications following esophagectomy for Barrett's cancer.~   "
44161|NCT02478983|"~     The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5~     supreme LMA compared to proseal LMA for infants weighing <10kg.~   "
44162|NCT02478970|"~     The corneal endothelium plays an important role in regulating stromal hydration and~     maintaining the transparency of the cornea. For evaluating the cornea, the most important~     parameters are corneal endothelial morphology and central corneal thickness. The specular~     microscope does this. The image in specular microscope is obtained by the specular reflex at~     a regular, smooth-surfaced interface of two refractive indices, with the angle of the light~     passing into the cornea equal to the angle of reflection to the observer. To obtain a clear~     image, the endothelial apical surface must be smooth and uniform and the cornea must be~     transparent. Nowadays different types of specular microscope exist.~      The investigators propose to compare the endothelial cells with two specular microscopes:~     the Konan SP4000, which is the current model and used for standard of care, to the Nidek~     CEM-350, which is a newly marketed device.~      The investigators would like to evaluate the patients in the clinic and have assessments~     completed with both specular microscopes.~      Nidek will be loaning the specular microscope, NIDEK CEM-530, for the study.~   "
44163|NCT02478957|"~     This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in~     adult patients with indolent systemic mastocytosis (ISM).~      The purpose of the study is to determine the efficacy and safety profile of PA101 delivered~     via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using~     standard treatments.~   "
44164|NCT02478944|"~     Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel~     disease (IBD) to evaluate osophageal motility before and during therapy~      Material and methods: The investigators prospectively perform manometry in patients with or~     with symptoms consistent with IBD. The investigators evaluate esophageal motility with high~     resolution manometry before, during and after IBD therapy. Clinical data are also collected~     to find possible correlations. The study do not modify the planned IBD therapy, but observe~     motility findings.~   "
44186|NCT02478658|"~     Study the circulatory levels of irisin in response to one session of high-intensity~     resistance training in a group of healthy subjects.~   "
44165|NCT02478931|"~     The purpose of this study is to learn more about personalized cancer therapy including~     response to treatment and side effects. Information about the tests and treatments a person~     received, or will receive, for their cancer will be collected from medical records to help~     the researchers determine whether or not patients respond better when their physicians~     choose to treat them according to the genetic makeup of their tumor. Optional research tests~     may be performed on tissue, body cavity fluid, blood or urine provided, discarded biological~     samples taken during routine care that would normally be disposed of and not saved, or on~     blood samples collected for this study. These research tests will be used to create a~     profile of the collected specimens which will describe unique characteristics about the~     genes involved in a person's cancer. The tests will also help researchers look for~     biomarkers that may help predict how people respond to treatment.~   "
44166|NCT02478918|"~     This is a quality improvement study to determine the impact of an automated telephone~     reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.~   "
44167|NCT02478905|"~     The epidemiology and transmission dynamics of influenza in hospitals are only poorly~     understood, particularly with respect to subjects without symptoms of influenza infection~     (e.g. without fever, cough, sore throat, nasal congestion, weakness, headache, loss of~     appetite, or myalgia). Knowledge about whether asymptomatic subjects are able to transmit~     influenza is of major importance. If they do transmit influenza, vaccination of patients and~     healthcare workers (HCW) before start of the influenza season, the permanent use of masks by~     HCW during influenza season, and quarantine for previously exposed inpatients may be the~     only available measures to reduce the number of influenza transmission events from~     asymptomatic subjects in acute care hospitals.~      The investigators' key aim is therefore to define whether exposure to asymptomatic subjects~     with influenza infection constitutes a risk for influenza transmission in an acute care~     hospital setting through active, prospective surveillance.~      The investigators' secondary aims are to describe the prevalence of community-acquired~     symptomatic and asymptomatic influenza upon hospital admission and the incidence of~     asymptomatic and symptomatic nosocomial influenza among inpatients; to assess transmission~     dynamics of symptomatic influenza infection in acute care; and to study the incidence of~     asymptomatic and symptomatic influenza, absenteeism (i.e. being absent from work due to~     influenza), presenteeism (i.e. being present at work despite influenza infection) associated~     with influenza, and compliance with infection control recommendations to prevent spread of~     influenza in acute care HCW.~      The investigators plan to enroll 1,260 inpatients and 180 HCW from medical wards at the~     University Hospital Zurich in a prospective study over two consecutive influenza seasons in~     order to detect at least one transmission event from an asymptomatic individual shedding~     influenza virus. Flocked mid-turbinate nasal swabs will be collected daily from consenting~     inpatients starting from day of admission until two days after discharge and from HCW over~     the influenza (winter) season and analyzed for influenza A and B using polymerase chain~     reaction. Simultaneously, signs and symptoms of influenza infection (including cough, sore~     throat, fever >37.8°C, nasal congestion, weakness, headache, loss of appetite or myalgia) as~     well as contact patterns between inpatients and HCW will be recorded. Reconstruction of~     influenza transmission chains will be based on phylogenetic analyses derived from~     next-generation sequence data and epidemiological contact tracing.~   "
44168|NCT02478892|"~     The study is a prospective, observational, case-control study evaluating the utility of~     endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic~     lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2~     mutations.~   "
44169|NCT02478879|"~     The purpose of this study is to determine which of two delivery methods of Parathyroid~     Hormone (PTH) is preferred by patients after 14 days of use for each.~   "
44170|NCT02478866|"~     BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl~     kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against~     c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This~     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary~     anti-tumor activity of BPI-9016M with single doses and multiple doses.~   "
44171|NCT02478853|"~     The prevention and control of lifestyle-related non-communicable chronic diseases, including~     diabetes, obesity and cardiovascular disorders, that share common risk factors, has now~     become a major focus of the World Health Organization. Lifestyle modification, like~     improvement of diet, physical activity and tobacco cessation, is the corner stone of~     diabetes and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the~     leadership of decision-makers of our regional health Agency in order to improve~     accessibility and quality of care, our team has collaborated to the development and~     implementation of an integrated care framework for the prevention and management of~     cardio-metabolic chronic diseases in primary care. This new care framework is currently~     being implemented in the context of community health centers (fall 2014) and family medicine~     groups (spring 2015), with the support of a Quebec Ministry of Health grant. The current~     research proposal aims to evaluate the implementation of this new care framework and explore~     its impact in the primary care context. This project is very important as it will generate~     knowledge on new models of care integrating preventive and management interventions in~     primary care settings, in continuum with specialized health care services and their~     implementation in an entire region.~   "
44172|NCT02478840|"~     The overall objective is to evaluate the long-term efficacy of Lamazym i.v. treatment in~     patients with alpha-Mannosidosis previously enrolled in Lamazym trials and currently~     receiving the treatment according to the AfterCare Program.~   "
44173|NCT02478827|"~     Schizophrenia is associated with a wide range of symptoms impacting a number of different~     domains, including cognitive impairment. Given the array of cognitive deficits associated~     with schizophrenia and their relationship to daily functioning, numerous research groups~     have examined the impact of cognitive remediation on many aspects of cognition. However, it~     is currently unclear as to which domains of cognition should be targeted to produce the most~     widespread and durable benefits for schizophrenia patients. It may be the case that~     targeting lower-level cognitive processes that are important for higher-level and more~     complex aspects of cognition may produce the most widespread benefits in cognition and~     everyday functioning. Relatively few studies have examined the effects of working memory or~     processing speed training on individuals with schizophrenia, as most studies examine~     broad-based remediation programs. Thus, there is a need for targeted working memory and~     processing speed training studies to better understand the mechanisms of cognitive~     enhancement through training in patients. This study will aim to: 1) investigate~     near-transfer gains associated with working memory and processing speed training in~     schizophrenia patients, 2) investigate far-transfer gains associated with working memory and~     processing speed training (i.e., gains in other neurocognitive domains and social~     cognition), and 3) investigate real-world gains associated with training (i.e., gains in~     daily functioning). Towards this aim, 81 schizophrenia patients will be recruited and~     randomly assigned to a working memory training group, a processing speed training group, or~     a no training control group. Training will be completed at home for 30 minutes per day, 5~     days per week, for a total of 10 weeks. Neurocognitive, social cognitive, and daily~     functioning measures will be administered both pre- and post-training to detect~     training-related gains.~   "
44187|NCT02478645|"~     Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery~     experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with~     HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such~     as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients~     is unknown. The aim of this study is to determine the effective dose of ramosetron for~     prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based~     patient-controlled analgesia after gynecological laparoscopic surgery.~   "
44174|NCT02478814|"~     Protein requirements in active individuals have been suggested to be greater than the~     current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order~     to characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in active, young adult males~     using the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
44175|NCT02478801|"~     Protein requirements in individuals who participate in endurance-based exercise training~     have been suggested to be greater than the current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order~     to characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than RDA based~     on nitrogen balance data.~      Therefore, the purpose of this study is to measure the protein requirement in endurance~     trained adults using the IAAO technique.~   "
44176|NCT02478788|"~     The main purpose of this study is to see the affects of the study medication called mixed~     amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The~     researchers also want to see if MAS-XR makes your child more or less likely to develop~     problems like acting out (i.e. periods of irritability, agitation, aggression).~      MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat~     attention deficit hyperactivity disorder (ADHD) in adults, children and adolescents.~   "
44177|NCT02478775|"~     Excess maternal weight, especially obesity, influences almost every aspect of fertility,~     from conception to problems during pregnancy. The investigators will use novel statistical~     methods to clarify the hormonal changes behind reproductive health conditions. A better~     understanding of reproductive hormonal changes in obese women may offer a way to identify~     new treatments.~   "
44178|NCT02478762|"~     In a previous study, the investigators established the dosage of foetal glycated hemoglobin~     (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also~     compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM)~     and determined that newborn of women with GDM had significantly higher FGH that newborn of~     women without GDM.~      In this study, the investigators want to compare the FGH of newborn of GDM women randomized~     to a group reaching the Canadian Diabetes Association recommended blood glucose objectives~     treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower~     blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)~   "
44179|NCT02478749|"~     The purpose of this study is to determine the effect of arm retraction on the~     supraclavicular approach for subclavian vein catheterization in adults and children.~   "
44180|NCT02478736|"~     Postoperative delirium is an important problem in patients undergoing major cardiac surgery~     and associated with more complicated hospital course, increased hospital length of stay and~     total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is~     associated with postoperative delirium after on-pump cardiac surgery. Another study showed~     that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity~     in the left middle cerebral artery (MCA) preoperatively are at greater risk for~     postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that~     lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good~     predictors of the postoperative delirium in the patients undergoing the on-pump cardiac~     surgery.~   "
44181|NCT02478723|"~     A post market, observational study evaluating the treatment of 1st and 2nd molars indicated~     for root canal therapy and treated with the Sonendo GentleWave System and obturated with~     CPoint and BC Sealer in at least one canal.~   "
44182|NCT02478710|"~     The purpose of this study is to determine if administering inhaled antibiotics directly into~     the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and~     decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV~     antibiotics alone.~   "
44183|NCT02478697|"~     Previous findings indicate elevated risk for tobacco use among adults in California who are~     unemployed and seeking work. In a pilot study, tobacco use was associated with a longer~     duration of time out of work. This community-based participatory research study aims to~     deliver and evaluate the impact of a web-based job seeker tailored tobacco cessation~     intervention vs. a control group in the San Francisco Bay Area. This research investigates~     whether an employment-centered tobacco treatment intervention is efficacious in supporting~     abstinence and also associated with more timely engagement of employment.~   "
44184|NCT02478684|"~     Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the~     placenta through the umbilical cord to the infant, thus resulting in a placental~     transfusion. This transfusion may improve circulating volume at birth leading to a smoother~     postnatal transition and overall improved outcome for preterm infants. The average blood~     volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about~     12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to~     cesarean deliveries. Several several short-term benefits have been described including a~     reduction in the need for blood transfusions as well as a possible reduction in~     intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened~     preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following~     consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord~     clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will~     be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent~     difference in the hematocrit at one hour (routinely obtained on all babies). With~     approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect~     a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided~     significance level.~   "
44188|NCT02478632|"~     The purpose of this study is to evaluate any change from baseline in bone mineral density~     (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen~     containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase~     inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in~     subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2).~      This open-label, parallel group, study is a sub-study which will recruit subjects who are~     receiving ART regimens which include TDF at the time of randomization to receive treatment~     in one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are~     Phase III, randomised, open-label, multicentre, parallel-group, non-inferiority studies~     evaluating the efficacy, safety, and tolerability of switching to DTG plus RPV from current~     integrase inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral~     regimen in HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic~     acid (RNA) levels <50 copies per millilitre (c/mL). Randomisation in the parent studies will~     be stratified by baseline third agent class (INI, NNRTI, or PI), age group (< or =>50 years~     old) and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore~     there will also be balance across the treatment arms in this sub-study both overall and with~     respect to baseline third agent class and age at entry.~      The study population will include approximately 75 evaluable subjects recruited from the~     Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and~     approximately 75 evaluable subjects from the Late Switch group who continue their current~     antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1~     and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed~     at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled~     visits in the parent studies.~   "
44189|NCT02478619|"~     The purpose of this study is to assess the effect of preoperative inspiratory muscle~     training in patients with grade III obesity undergoing bariatric surgery. It will be a~     double-blind randomized controlled clinical trial with volunteers allocated in two groups~     that will be compared according to postoperative evolution (pulmonary complications, lung~     function, strength and endurance of the respiratory muscles and respiratory system~     resistance).~   "
44190|NCT02478606|"~     This study investigates the influence of two different stretching techniques on the~     flexibility of the muscles that are in the posterior thigh, after a training period.~      The study will last for six weeks where the volunteers need to go to the lab twice for~     evaluation, and for four weeks, three times a week for the application of stretching~     training.~      Evaluation before and after the training period consists of applying hip and knee~     flexibility tests, evaluation of strength, muscle activation and muscle architecture. The~     Flexibility tests are: (1) Straight Leg Raise Flexibility Test (SLR), where the volunteer~     will be positioned supine on a stretcher. Then the appraiser will perform hip flexion~     keeping the knee extended and relaxed foot to the angle at which the person refer discomfort~     while the contralateral limb remain firmly leaning on the table; (2) Modified Passive knee~     extension (TEJ), where the volunteer will be positioned supine on a stretcher. The assessor~     shall determine the hip member to be rated at 90º and perform knee extension to the angle at~     which the person refer discomfort. The contralateral limb remain firmly leaning on the~     table.~      For the evaluation of muscle strength the volunteer had sat on equipment, makes five~     repetitions of bending and straightening the knee to familiarize yourself with the equipment~     and after will make other five replicates doing maximum strength.~      To evaluate the electrical activity will be the depilation of the skin with a razor and~     cleaning with an alcohol swab after adhesive electrodes will be placed for collection of~     muscle activity, the electrodes do not emit shocks.~      The muscle architecture will be assessed via a ultrasound , to its use the use of a water~     soluble gel to improve the machine's skin contact is required.~      For the intervention, the stretching will be held in both legs, where the volunteer will~     remain lying on a stretcher with fixed trunk with velcro straps and the researcher will~     carry out the elongation raising the leg drawn to the moment of discomfort the volunteer~     will refer and will remain for 30 seconds (s) in case he belongs to passive static~     stretching group, if the stretching group of proprioceptive neuromuscular facilitation, will~     be in the same position, but before the 30s of stretching, he you will have to push against~     during 6s to lower leg against the researcher.~      If he belongs to the control group, have only two trips to the laboratory for testing, will~     make an initial assessment and after four weeks will return to perform the tests again, in~     the period between assessments will not need to go to the lab because it does not make~     intervention elongation.~      It is possible that there discomfort during flexibility testing, strength testing and~     stretching training. After the tests can still experience muscle pain should disappear~     within 48 hours. The risks of research are minimal, not exceeding those of a strength~     training session and stretching.~   "
44191|NCT02478593|"~     The overall goal of this research is to develop and test strategies to decrease potentially~     inappropriate medication use among the elderly.~   "
44192|NCT02478580|"~     Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative~     morbidity and mortality. This group of patients is at risk of perioperative desaturations~     which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA~     patients might also need to spend the night in intensive care for more frequent monitoring~     for any desaturations episodes especially if the patient will be requiring multiple~     intravenous narcotic boluses for pain control. Several studies have looked into the most~     appropriate way to manage these patients and some recommendations have been made to avoid~     outpatient surgery with close monitoring for first 24 hours after surgery specifically if~     patient will require intravenous postoperative narcotics.~      Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA~     approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and~     obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer)~     or modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.~      Nuvigil is longer acting product which is similar in action to Modafinil however is much~     cheaper. Nuvigil has not been previously studied for postoperative recovery. The~     investigators intend to study the effects of Nuvigil on postoperative recovery time and~     wakefulness in obstructive sleep apnea and obese patients.~   "
44193|NCT02478567|"~     Randomized crossover trial evaluating the impact of exercise training sequence of~     axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement~     syndrome.~   "
44194|NCT02478554|"~     Fetal growth abnormalities is one of the most common problems faced in modern obstetrics.~     The association between low birth weight and perinatal death as well as severe morbidity is~     well known. Since fetal weight cannot be measured directly, obstetricians use estimates of~     fetal weight obtained by utilizing various ultrasonographic measurements to diagnose growth~     abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers~     employ population-based fetal growth curves that have been previously published and updated~     to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10%~     percentile for estimated fetal weight in population-based growth curves are actually~     constitutionally small; that is a neonate deemed small based on standardized growth curves~     but in reality have reached its appropriate growth potential in relation to its genetic~     predisposition.~      An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed~     that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from~     15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency~     cesarean delivery and shoulder dystocia are increased significantly.~      Various ultrasound parameters have been tested in an effort to detect both fetal compromise~     prior to the development of permanent damage and allow differentiation between true fetal~     growth abnormalities and normal growth potential. Recent reports have introduced the concept~     of customized fetal growth curve which uses physiological variables to report an adjusted~     fetal growth assessment. To date, the use of customized fetal growth curves has not been~     evaluated prospectively. Furthermore, this strategy has not been compared to standard~     population-based fetal growth curves currently used in clinical practice to determine which~     would be the most ideal for use in clinical practice.~      The primary research question is: are customized fetal growth curves more accurate than~     population-based fetal growth curves at predicting abnormalities in fetal growth, defined as~     small-for-gestational age or large-for-gestational age at birth in newborns of high-risk~     pregnancies? Randomly, participants will be assigned to either having fetal growth reported~     by customized or population bases growth curves.~   "
44243|NCT02477917|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability~     of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with~     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity.~   "
44195|NCT02478541|"~     High levels of fatty substances in the blood increase the risk of developing coronary heart~     disease and having a heart attack. The investigators know a lot about one of these fatty~     substances, cholesterol. However, there is another fatty substance in the blood called~     triglyceride. The investigators do not understand much about what regulates the rate at~     which the liver produces triglyceride and liberates it into the bloodstream after eating a~     meal(s). The investigators are developing new techniques to measure these processes in~     healthy people. Ultimately a deeper understanding of the regulation of this process might~     lead to the development of new treatments for fat accumulation in the liver and high blood~     fat levels and related disorders. The present study is an investigation of how these~     processes relate to various bodily characteristics such as thinness and fatness and the~     distribution of fat in the body.~   "
44196|NCT02478528|"~     Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact~     at the individual level but also social and economic level (loss of productivity, morbidity,~     mortality) emphasize the need for one hand, to improve the investigators' understanding of~     these disorders in order to develop appropriate therapeutic tools and on the other hand, to~     increase the investigators' support abilities of patients with these disorders.~      The investigators' team of unity sleep from Strasbourg University Hospitals, in~     collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of~     new concepts and tools to compensate the investigators' sleep debt in order to apply them to~     patients with sleep disorders and persons who face with sleep restriction.~   "
44197|NCT02478515|"~     Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular~     edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is~     expected that similar results could be obtained by less frequent IVR. The purpose of this~     study is to investigate if IVR by PRN is as effective as by monthly. In addition, the~     investigators are going to study the relationship between macular edema and the size and~     location of retinal non-perfusion area.~   "
44198|NCT02478502|"~     Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination~     with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of~     germ cell cancer.~      Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical~     activity in patients with metastatic and progressive germ cell tumors.~   "
44199|NCT02478489|"~     The specific aims of this pragmatic randomized controlled trial are to compare initiating~     injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of~     discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1)~     alcohol consumption and consequences, and 2) acute healthcare utilization (including~     hospital readmission and emergency visits) and cost-effectiveness. In exploratory analyses,~     the investigators will assess moderators of medication effects including demographic,~     behavioral, and genetic factors.~   "
44200|NCT02478476|"~     The presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and~     taxane metabolism and detoxification have been correlated to increased risk of severe~     adverse events (AEs) when patients receive these drugs. The investigators propose studies to~     validate a comprehensive panel of twelve SNPs in ovarian cancer patients that may predict~     AEs when treated with therapies that include platinum and taxanes. Using these results to~     stratify patients to different dosing regimens, routes of administration, or in recurrent~     cancer to aid in drug selection, may improve outcome and reduce costs for the management of~     drug related side effects while not changing standard of care. Since these differences can~     be detected from blood, the determination of genotypes can be done using a standard blood~     sample taken after ovarian cancer is confirmed on the patient's pathology report. These~     genetic differences can be detected by QPCR and Next Generation Sequencing.~   "
44201|NCT02478463|"~     Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency~     virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and~     infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical~     sites associated with sexual HIV transmission following the proposed 600 milligram (mg)~     intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB~     distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1~     transmission and supplement the data to support future PrEP clinical trial development. The~     primary objective is to determine the PK concentrations of CAB following LA administration~     in plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF)~     in healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women~     following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy~     subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations~     associated with sexual HIV-1 transmission: vaginal tissue, cervical tissue, cervicovaginal~     fluid, rectal tissue, and rectal fluid. The study will consist of a screening period, a~     28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-21 day washout period,~     and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental~     pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety~     assessments and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a~     follow-up/withdrawal visit at Week 52 post-injection~   "
44202|NCT02478450|"~     This study is a non-randomized, open-label, partially blinded, sequential cohort,~     dose-escalation study designed to obtain preliminary data on the safety, tolerability, and~     early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort~     receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will~     receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and~     outcome measure assessors will be blinded to side of treatment. The study will be conducted~     at sites with extensive clinical experience with the care of patients with ALS.~   "
44244|NCT02477904|"~     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,~     and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be~     comprised of children (2-21 years of age) based on whether or not they have ASD and receive~     the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic~     diet.~   "
44420|NCT02475616|"~     This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study~     to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in~     healthy adult males.~      Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.~   "
44203|NCT02478437|"~     This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the~     medial branch nerves of the lumbar facet joint is effective for the treatment of low back~     pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that~     the brain does not receive the message that the low back is in pain. This technique is~     commonly performed by burning these nerves rather freezing them, but it is suspected that~     freezing them results in better pain relief. The CRFA blocks has been shown to effectively~     treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is~     suspected that CRFA will be effective when treating pain related to facet joints in the low~     back. We are performing this study in order to determine if that is the case.~   "
44204|NCT02478424|"~     Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent~     anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study~     (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell~     transplantation were given CBD 300 mg/day starting 7 days before transplantation until day~     30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of~     methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients~     developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the~     cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and~     5%, respectively. Compared to 101 historical control subjects given standard GVHD~     prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with~     CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than~     100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months~     were 20% and 33%, respectively.~      The aim of this study is to explore the safety and efficacy of extended use of CBD until day~     100 in the prevention of acute and chronic GVHD.~   "
44205|NCT02478411|"~     Study designed to evaluate the functional and motor effects in critically ill subjects at~     ICU and hospital discharge with the incorporation of a mobilization program of~     cycloergometric physiotherapy sessions compared with conventional physiotherapy.~   "
44206|NCT02478398|"~     The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed~     [Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy~     tablets in children aged 5 to 17 years with ragweed-induced allergic~     rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is~     that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of~     age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis~     symptoms and medication use over the peak ragweed season (RS).~   "
44207|NCT02478385|"~     The main purpose of this study is to explore the impact of the birth environment on women's~     birth experience and relevant birth outcomes in the experimental Labour room compared to a~     standard Labour room.~   "
44208|NCT02478372|"~     The purpose of this study was to determine if the method of peri-operative analgesia used~     following total Knee Replacement surgery affected the progress towards rehabilitation goals~     and to determine whether the analgesia had any impact on long term outcomes.~   "
44209|NCT02478359|"~     Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the~     US. The personal, social and economic costs of the disease are tremendous, with annual~     expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD~     and associated sequelae. For the vast majority of patients, despite optimal pharmacological~     therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity,~     deconditioning, and an insidious downward spiral of social isolation and depression that has~     a profound impact on the lives of patients and their caregivers. There is mounting evidence~     that physical inactivity is significantly associated with more frequent hospitalizations and~     increased mortality in COPD even after adjusting for disease severity.~      While practice guidelines recommend regular physical activity for all patients with COPD,~     health systems are challenged in operationalizing an effective and sustainable approach to~     assist patients in being physically active. The investigators propose a pragmatic randomized~     controlled trial to determine the effectiveness of a 12-month physical activity coaching~     intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large~     integrated health care system.~   "
44210|NCT02478346|"~     This study focuses on implementing Yellow 560 for the direct intraoperative visualization of~     Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop~     better treatment protocols, and improve the prognosis of a wide array of neurosurgical~     diseases. More specifically, for the patients who are undergoing surgical intervention for~     the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the~     investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or~     in general residual lesion which must be corrected.~   "
44211|NCT02478333|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy~     Japanese adult participants.~   "
44212|NCT02478320|"~     The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to~     control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change).~     The safety of this drug will also be studied.~   "
44213|NCT02478307|"~     Up to 80% of Australians experience back pain and 10% have significant disability as a~     result. There is a critical need for the development and evaluation of innovative treatments~     that have the capacity to target the multidimensional nature of chronic low back pain. This~     study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy,~     and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately~     lead to streamlined interventions designed to efficiently maximise benefit.~   "
44214|NCT02478294|"~     This cohort study aims to evaluate thoracoscopic left atrial appendage excision with~     warfarin for the prevention of stroke and non-central nervous systemic embolism in patients~     with atrial fibrillation and thromboembolism.~   "
44215|NCT02478281|"~     A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of~     Methylene Blue Injection, USP 1 mg/kg in healthy adult voluneetrs.~   "
44421|NCT02475603|"~     Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet~     During Total Knee Arthroplasty:~      WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy~     analysis~   "
44216|NCT02478268|"~     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using~     inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung~     function and detect changes over time in patients receiving treatment as well as those who~     don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show~     areas of abnormal thickening of parts of the lungs. These images combined with images taken~     with injected contrast agents or other types of MRI may provide a better way to look at lung~     structure and function in patients with IPF. The ultimate goal is to predict how a~     particular patient might respond to a particular therapy and to observe such responses~     earlier than conventional tests. The investigators anticipate that the images acquired in~     this study will provide more specific information about lung disease than standard lung~     function tests. The use of 129Xe MRI is investigational. Investigational means that these~     tests have not yet been approved by the US Food and Drug Administration and are being tested~     in research studies like this one. In addition, standard MRI with contrast is not typically~     done as standard of care for monitoring progression of IPF, therefore, its use in this study~     is also considered investigational.~      Healthy volunteers are being asked to participate in this study because the investigators~     need to develop a database of functional images that are representative of healthy lungs.~   "
44217|NCT02478255|"~     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using~     inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize~     impaired lung function and detect changes over time in patients receiving treatment as well~     as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be~     able to show areas of abnormal thickening of parts of the lungs. These images combined with~     images taken with injected contrast agents or other special types of MRI such as~     conventional proton (1H) MRI may provide a better way to look at lung structure and~     function. The ultimate goal is to predict the degree of radiation-induced lung injury that~     will develop in a given patient for a given treatment plan. The investigators anticipate~     that these images will provide more specific information about lung disease than standard~     lung function tests. The use of 129Xe MRI is investigational. Investigational means that~     these tests have not yet been approved by the US Food and Drug Administration and are only~     available in research studies like this one. In addition, standard MRI with contrast is not~     typically done as standard of care for monitoring changes due to thoracic radiation therapy,~     therefore, its use in this study is also considered investigational.~      Healthy volunteers are being asked to participate in this study because to develop a~     database of functional images that are representative of healthy lungs.~   "
44218|NCT02478242|"~     Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during~     continuous renal replacement therapy in acute kidney injury patients at a high risk of~     bleeding.~   "
44219|NCT02478229|"~     The study is a single centre, single arm, open-label, proof of concept study enrolling 20~     adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will~     receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation~     (OLT) and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.~   "
44220|NCT02478216|"~     The patients were allocated randomly to receive remote preconditioning group (RIPC group, R)~     or not (Control group, C) using sealed envelopes with the options inside the sealed envelope~     of R and C before anaesthesia induction. The registered nurse who did not participate in~     patient care and was blind to the study performed the all randomization process. All medical~     staffs who involved the patient care were blind to the study. All data were collected by~     trained observers who were blind to the study and did not participate in patient care~   "
44221|NCT02478203|"~     After Local Human Research Ethics Committee approval, emergency medical staff enrolled in~     this study. After watching a video about the intubation using Airtraq, Glidescope or direct~     laryngoscopy, they attempted to intubate a pediatric manikin in three different airway~     models.~   "
44222|NCT02478190|"~     Emergency Department (ED) patients with severe hyperglycemia will be randomized to two~     treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.~      Randomization is stratified by whether the chief complaint is High Blood Sugar in the~     electronic medical record or other.~   "
44223|NCT02478177|"~     The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is~     designed to provide important and timely insight into the management of acute stroke~     patients who are on novel oral anticoagulants in community practice.~   "
44224|NCT02478164|"~     This research study is studying a chemotherapy as a possible treatment for recurrent~     glioblastoma that has not responded to bevacizumab. The name of the study drug involved in~     this study is Ponatinib.~   "
44225|NCT02478151|"~     This trial will examine the safety and feasibility of using the OrganOx Metra device to~     transport and store donor livers under normothermic conditions prior to transplantation.~     Participants will be followed for 3 months following transplantation and their outcomes~     recorded.~   "
44226|NCT02478138|"~     Cervical lymph node involvement, in head and cancer neck patients, is one of the most~     important prognostic factors. Currently patients undergo neck dissection removing some or~     all nodes and neck involvement is retrospectively determined. Sentinel lymph node (SLN)~     identification and biopsy has become clinical practise in other areas including breast,~     skin, and gastric cancer. The gold standard for detecting metastatic lymph nodes is~     pathological analysis, but the lack of an accurate or clinically accepted way to identify~     sentinel lymph nodes in the cervical region has motivated the usage of indocyanine green~     (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo). A~     prospective clinical trial using a commercially available NIR system and ICG injection~     around the tumour site will evaluate the ability to detect and biopsy sentinel lymph nodes~     in head and neck cancer patients.~   "
44227|NCT02478125|"~     Hypothesis: Treatment with Burixafor hydrobromide will effectively mobilize metastatic~     prostate cancer (PCa) cells (i.e. disseminated tumor cells; DTCs) into the blood from the~     bone marrow. It has been demonstrated that prostate cancer cells have been mobilized out of~     the bone marrow of mice utilizing an anti-CXCR4 strategy; making them more susceptible to~     chemotherapy.~   "
44422|NCT02475590|"~     Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric~     bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and~     secondary outcomes on nutritional status, glycolipid profile, quality of life and pain~     assessments.~   "
44228|NCT02478112|"~     The benefit of dose escalation in radiotherapy (RT) for biochemical control of prostate~     cancer is a clearly established fact based on the results of different published prospective~     trials. This benefit, acquired with three-dimensional conformal radiation technique is~     counterbalanced by an increase in urinary and gastrointestinal toxicity. The joint progress~     of dose planning systems and multileaf collimators (MLC) technology have enabled the~     Intensity Modulated Radiation Therapy (IMRT). Recently the contribution of spacers~     positioned in the septum between the rectum and the prostate could improve the functional~     results of IMRT in terms of rectal toxicity.~      The aim of the investigators study is to assess the dosimetric gain from the contribution of~     the implantable BioProtect balloon on organs at risk.~   "
44229|NCT02478099|"~     To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET and 18F-FB-IL2-PET -~     as complementary tools for selection of patients to be treated with MPDL3280A, within this~     treatment trial the investigators will assess safety, tolerability and anti-tumor activity~     of MPDL3280A in cancer patients, who have undergone investigational imaging.~   "
44230|NCT02478086|"~     Introduction:~      The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional~     conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein~     synthesis, but also intervene in weight gain. Most newborns receive amino acids throw~     parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth~     weight when discharged, so the weight its below the 10th percentile, which rises the risk~     for presenting alterations in neurodevelopment.~      Objective:~      To compare a higher doses of parenteral amino acids vs. standard doses, expecting an~     increased weight gain in the high amino acid doses group, meanwhile following the renal~     function security profile~      Methods:~      A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad~     Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the~     city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard~     doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to~     an experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured~     weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs~     and with less than 32 weeks of gestational age that match all the inclusion criteria.~     Statics Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact~     test were applied to categorical variables, t-student test to continuous variables, and~     ANOVA in multiple groups.~   "
44231|NCT02478073|"~     Antibiotic dosing in critically ill patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      Patients in the Intensive Care Unit (ICU), treated with piperacillin/tazobactam, had their~     plasma concentration of piperacillin determined 1-3 times weekly. Patients received~     piperacillin as intermittent bolus infusion 3 times daily or as continuous infusion (this~     was up to the treating physician). Time above the minimal inhibitory concentration (T>MIC)~     estimated for each patient was evaluated against clinical breakpoint MIC for Pseudomonas~     aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f~     T>MIC (free piperacillin concentration maintained above the MIC throughout the dosing~     interval) and 50% fT>4xMIC (free piperacillin concentration maintained at a level fourfold~     the MIC for at least 50% of the dosing interval).~   "
44232|NCT02478060|"~     The purpose of this study is to evaluate the safety and tolerability of multiple~     administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic~     parameters and clinical outcomes.~   "
44233|NCT02478047|"~     The purpose of this study is to clarify whether distal-proximal point association is more~     effective than partial match point association by electro-acupuncture in the management of~     chemotherapy-induced nausea and vomiting .~   "
44234|NCT02478034|"~     In this study the effects of mineralocorticoid stimulation on social cognition will be~     investigated in healthy young individuals.~   "
44235|NCT02478021|"~     The effects of hydrocortisone on cognition will be investigated.~   "
44236|NCT02478008|"~     The purpose of the study is to evaluate the initial short and long-term safety and~     performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the~     Transapical Delivery System.~      The study will enroll patients with moderate to severe mitral valve regurgitation who are~     considered high or extreme risk for mortality and morbidity from conventional open heart~     surgery.~   "
44237|NCT02477995|"~     Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using~     of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced~     incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may~     cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine~     has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.~     In 1995, DTaP was successfully developed in China, and have been used in EPI at present.~     Because of effective immunity and little side reaction, DTaP has been widely recognized and~     accepted by the parents.~   "
44238|NCT02477982|"~     The primary objective of this study is to develop a descriptive and predictive~     pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and~     lean patients.~   "
44239|NCT02477969|"~     This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical~     study that will enroll approximately 564 T2DM patients who before screening have~     inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8~     weeks of metformin monotherapy at stable doses（≥1500 mg/day).~   "
44240|NCT02477956|"~     Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12,~     Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is~     giving to patients with their routine supplements and followed up for 6 months.~      Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements~     in addition to the standard vitamin D protocol will have a significant rise in serum vitamin~     D levels compared to the subjects taking only the usual vitamin D protocol.~   "
44241|NCT02477943|"~     This study is designed to collect data which will be used to correlate changes in EEG to~     mild TBI in sports concussion.~   "
44242|NCT02477930|"~     The purpose of this registry is to collect data on the clinical use of endoluminal vacuum~     (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.~   "
44245|NCT02477891|"~     The objective of this study is to provide early access to daratumumab treatment and collect~     additional safety data while the medication is not commercially available or available~     through another protocol for subjects with multiple myeloma who have received at least 3~     prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent~     (IMiD) or whose disease is double refractory to both a PI and an IMiD.~   "
44246|NCT02477878|"~     A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual~     disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of~     increasing doses of BPX-501 T cell infusions to achieve a clinical response. AP1903 will be~     investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose~     that can mitigate GvHD and preserve the graft-versus tumor effect.~   "
44247|NCT02477865|"~     This is a phase III, multicenter, randomized, double-blind, placebo-controlled study~     planning to include approximately 387 T2DM patients who have received at least 8 weeks of~     treatment with diet control and exercise； have not received any glucose-lowering agents~     within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The~     subjects would receive PEX168 or placebo monotherapy for 52weeks in total.~   "
44248|NCT02477852|"~     The purpose of this study is to determine the better preoperative anti-tuberculosis~     treatment period of patients with spinal tuberculosis.~   "
44249|NCT02477839|"~     The purpose of this trial is to assess the effectiveness and the safety of Lacosamide~     administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for~     children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled~     partial-onset seizures.~   "
44250|NCT02477826|"~     The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab, or~     nivolumab plus platinum-doublet chemotherapy improves progression free survival and/or~     overall survival compared with chemotherapy in subjects advanced lung cancer~   "
44251|NCT02477813|"~     It is a single-arm, open label clinical trial. Patients affected by relapsed or refractory~     small-cell lung cancer patients with MGMT promoter methylation are included in this study;~     they will be treated with oral Temozolomide 200 mg/m2 die for 5 consecutive days every 28~     days. Treatment will be continued until tumor progression, intolerable toxicity or patient~     refusal.~      A Minimax Simon 2-stage design will be used. - First stage: 9 patients If 1 or less~     responses will be observed, the trial will be ended.- Second stage: other 10 patients (for a~     total of 19 subjects enrolled) If 5 or less responses will be observed in 19 patients, the~     treatment will not be considered active, while if 6 or more responses will be observed, the~     treatment will be considered sufficiently active to warrant further testing. Since the rate~     of methylation ranges from 20 to 48% the number of patients to be screened should be between~     40 and 95.~      The primary objective is to determine the overall response rate [ORR = CR + PR]; the~     secondary objectives are to determine the time to Progression (TTP), the overall Survival~     (OS), the toxicity and the correlation between response Rate (RR) and the level of MGMT~     promoter methylation and/or base excision repair (BER) genes alterations.~   "
44252|NCT02477800|"~     The primary objective of the study is to evaluate the efficacy of monthly doses of~     aducanumab in slowing cognitive and functional impairment as measured by changes in the~     Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in~     participants with early AD. Secondary objectives are to assess the effect of monthly doses~     of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental~     State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13],~     and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment~     version) [ADCS-ADL-MCI].~   "
44253|NCT02477787|"~     This is a single center, open label, random comparison phase 2b study. The primary objective~     of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic,~     donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell~     transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML).~      The secondary objectives of the study are to assess the side effects of donor NK cell~     infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon~     post-HCT immune recovery.~   "
44254|NCT02477774|"~     This is a single-blinded multi-institutional randomized controlled trial to evaluate the~     effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol,~     Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites.~     Increased drainage from donor sites can lead to seroma formation with possible secondary~     infection, delayed hospital discharge, and additional home care needs for drain care. Arista~     is an inert plant based absorbable surgical hemostatic powder that can be easily applied to~     broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to~     free flap donor sites may bear significant potential benefit.~      Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral~     thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs~     and time to drain removal compared to ALT donor sites closed without Arista.~      Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will~     reduce postoperative ALT donor site seromas and patient hospital length of stay.~   "
44255|NCT02477761|"~     The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload~     on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent~     insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a~     75 g glucose ingestion in diet-controlled type 2 diabetic patients.~   "
44256|NCT02477748|"~     This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of~     MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.~      The study will be comprised of Screening, Washout (if required), Treatment (total of 10~     weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo~     initial eligibility assessments.~   "
44257|NCT02477735|"~     The purpose of this study is to investigate the prevalence of sleep disturbances in children~     with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion~     (TTI) on sleep disturbances.~   "
44313|NCT02477007|"~     The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and~     ibuprofen in association with morphine, compared with morphine alone on analgesia in~     children seen in the emergency department for a long-bone fracture and also to study the~     potential synergic effect of the association paracetamol and ibuprofen.~   "
44258|NCT02477722|"~     Exposure to life threatening, traumatic and stress inducing events in general is an~     inevitable part of military combat service . Among individuals exposed to a traumatic event,~     approximately 85-90 % will develop a stress response from which they will recover without~     need for any medical intervention whatsoever. However, roughly 10-15 % will continue to~     suffer from post-traumatic symptoms along with depression or anxiety disorders1, . The~     prominent symptoms of post - traumatic stress disorder (PTSD), consists of reliving the~     event via invasive and painful memories that include: images, thoughts or feelings, night~     terrors, and extreme emotional distress that arise when exposure to external or internal~     cues similar to or symbolizing aspects of the traumatic event. Following this distress,~     behavioral avoidance of situations that trigger unpleasant memories may develop. Such mental~     stress may lead to avoidance of social situations and hinder normal daily functioning in a~     variety of contexts2. The question arises as to what distinguishes between those who are~     exposed to a traumatic event and recover spontaneously and those who fail to resume daily~     life and develop PTSD. Attempts to find personality and environmental risk factors for the~     development of PTSD have yet to yield any unequivocal conclusions. This has lead the~     scientific community to look for neuro-physical risk factors as well . Furthermore, evidence~     that early diagnosis and treatment of the disorder helps reduce the severity of post-trauma~     symptoms -stresses the need for the accurate localization of neurological risk factors and~     new immediate and/or preventative interventions. The aim of the present project is to~     develop a brain oriented training method for early preventive interventions of PTSD.~   "
44259|NCT02477709|"~     This study assesses the tolerability of a single dose of AF-219 in participants with~     idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150 mg~     dose of AF-219 and undergo tolerability and PK assessments.~   "
44260|NCT02477696|"~     This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously~     treated chronic lymphocytic leukemia.~   "
44261|NCT02477683|"~     The purpose of this study is to collect data to support decisions made by BioFire regarding~     assay development, panel composition, and intended use for the final FilmArray FI reagent~     pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients~     under 3 years of age that present with acute fever.~   "
44262|NCT02477670|"~     The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability~     of AVP-786 as an adjunctive treatment compared with placebo in patients with residual~     schizophrenia.~   "
44263|NCT02477657|"~     Malignant ascites leads to significant morbidity in patients with terminal cancer.~     Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of~     relief after paracentesis are detrimental to quality of life(QOL). Two devices are available~     as alternatives to paracentesis. The impact of either device on QOL has not fully been~     explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom~     relief using validated survey instruments is proposed.~   "
44264|NCT02477644|"~     Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced~     FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or~     Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane~     Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.~   "
44265|NCT02477631|"~     The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload~     status in transfusion dependent, iron-overloaded low risk MDS patients;~      Primary Objective:~      • To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen~     species (ROS).~      Secondary Objectives:~        -  To evaluate the effect of Deferiprone on other oxidative stress parameters~             1. Reduced glutathione~             2. Membrane lipid peroxidation~             3. External phosphatidylserine~        -  To evaluate the change from baseline to last visit in parameters of iron load.~             1. Serum ferritin (despite ongoing RBC transfusions during the study period).~             2. LIP~             3. LPI~             4. serum hepcidin~        -  To evaluate the change from one month preceding baseline visit to last month on study~          in transfusion requirements.~        -  To monitor safety measures:~             1. Adverse events (AEs).~             2. Number of discontinuations due to AEs~      Study design:~      Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS.~     All participants will be treated with deferiprone for up to 4 months. Patients will have~     complete blood count monitored weekly, and will visit the site monthly for assessments of~     safety and efficacy.~   "
44266|NCT02477618|"~     This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the~     efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to~     subjects in Super-Refractory Status Epilepticus (SRSE).~   "
44267|NCT02477605|"~     The purpose of this study is to compare the treatment day change between immediate~     postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and~     23-gauge vitrectomy instruments.~   "
44268|NCT02477592|"~     The purpose of this study is to compare effectiveness of two substrate modification~     approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a~     substrate-based, individualized substrate modification (ISM)approach should be superior to~     traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the~     first study to evaluate the real substrate by means of electro-anatomic mapping and to~     perform true substrate modification in long standing persistent atrial fibrillation~     ablation(LPAF).~   "
44269|NCT02477579|"~     This study evaluates the safety and effectiveness of the a novel device called NovaCross to~     help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.~   "
44270|NCT02477566|"~     To test whether long-acting Triptorelin on pituitary down-regulation can improve the~     clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome~     (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro~     fertilization (IVF) or Intracytoplasmic sperm injection~   "
44314|NCT02476994|"~     This will be a descriptive study designed to evaluate the propensity for hospitalized~     pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days~     to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will~     evaluate the safety and efficacy of using Clinolipid in a pediatric population.~   "
44271|NCT02477553|"~     Experts believe that increasing the low uptake of screening for colorectal cancer (CRC)~     requires educating patients about all approved tests and helping them choose one that fits~     their preferences. As one motto puts it: The best test is the one that gets done.~     Screening tests range from more invasive and very sensitive for polyps and cancer~     (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing~     (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs~     involved. Some guidelines recommend that decision aids, a promising tool in this area,~     provide patients with detailed quantitative information, including baseline risk, risk~     reduction, and chance of negative outcomes. But this sort of comparative effectiveness~     data can confuse patients, especially those with limited mathematical ability. Previous~     studies have not measured the effect of providing quantitative information to patients with~     varying levels of ability or interest or asked them whether such data is essential for their~     decision-making.~      The investigators will conduct a clinical trial to determine the impact on patients who view~     a decision aid (DA) that includes quantitative information versus a DA without such data.~     The investigators will also seek to determine whether numeracy moderates the effect of~     quantitative information.~   "
44272|NCT02477540|"~     This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in~     critical limb ischemia.~   "
44273|NCT02477527|"~     Switch patients from Atripla to Stribild will be evaluated to see if patients have less~     sleep disturbances.~   "
44274|NCT02477514|"~     The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the~     single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.~   "
44275|NCT02477501|"~     The purpose of the study is to determine if norepinephrine is more effective as a continuous~     intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid~     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.~     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and~     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all~     participants will receive spinal anesthesia with a local anesthetic and morphine. This study~     plans to enroll 120 pregnant women. Patients will be randomly assigned according to a~     computer generated system to be in one of two groups.~   "
44276|NCT02477488|"~     Gout has a strong association with the metabolic syndrome, and it is often seen in patients~     with renal insufficiency. Allopurinol is a medication intended to lower uric acid and~     therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows~     that it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to~     lower uric acid if it was given after dialysis only. The investigators will then switch~     administration of allopurinol to bedtime for dialysis patients currently taking that~     medication.~   "
44277|NCT02477475|"~     The objective of this investigation is to collect following data in patients given NEXIUM~     capsule (NEXIUM) in usual post-marketing use.~   "
44278|NCT02477462|"~     Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial~     cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance,~     high titers of serum anti-mitochondrial autoantibodies (AMA) directed against the pyruvate~     dehydrogenase complex E2 subunit and evidence from both human and murine models suggests~     that T-cells, particularly cluster of differentiation (CD) 8+ T cells, are key to the~     destruction of bile ducts. However, clinical trials of classic immunosuppressive drugs~     including corticosteroids, azathioprine, methotrexate, and tacrolimus have been largely~     unsuccessful in altering the disease course. This is a single center, prospective,~     non-treatment study of the role of immune responses in PBC patients.~      Non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic~     steatohepatitis (NASH) are common, often silent liver diseases. NASH resembles alcoholic~     liver disease, but occurs in people who drink little or no alcohol. The major feature in~     NASH is fat in the liver, along with inflammation and fibrosis. NASH can be severe and can~     lead to cirrhosis and hepatocellular carcinoma. Ten to 20 percent of American have NAFLD~     with NASH affecting 2 to 5 percent of Americans.~   "
44279|NCT02477449|"~     Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.~   "
44280|NCT02477436|"~     This is an exploratory clinical study to presume the optimum usage and dosage for a~     therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg,~     100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In~     conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil~     50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.~   "
44281|NCT02477423|"~     The purpose of this study is to determine whether antibiotics given immediately after birth~     alter the development of the developing preterm infant's microbiome, which may further alter~     overall clinical outcomes.~   "
44282|NCT02477410|"~     The purpose of the study is to obtain a better understanding of how hydrolysed porcine~     proteins affect the human metabolism, including the effects on muscle protein synthesis,~     appetite and secretion of gastrointestinal hormones.~      It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis,~     affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey~     protein.~   "
44283|NCT02477397|"~     Study to investigate the effects of symptom-driven maintenance and reliever therapy in COPD.~   "
44284|NCT02477384|"~     The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm~     expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus~     propranolol for the prevention of recurrent esophageal variceal bleeding.~   "
44285|NCT02477371|"~     The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study~     is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary~     artery bypass grafting (CABG) with respect to planning and guiding the revascularization~     strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in~     patients planned for surgical revascularization.~   "
44325|NCT02476851|"~     This study evaluates whether whole blood transferred through the new POLFA needle assembly~     meets supernatant hemoglobin acceptability standards.~   "
48414|NCT02423356|"~     The purpose of this study is to investigate the heart functioning of patients being treated~     with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to~     better predict risk of developing symptomatic heart failure.~   "
44286|NCT02477358|"~     In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs~     after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is~     not performed, the pulp space can become infected. Platelet rich fibrin (PRF) is a second~     generation platelet concentrate that allows the clinician to obtain fibrin membranes~     enriched with platelets and growth factors from an anticoagulant-free blood harvest.~     Clinical relevance of PRF and revascularization has been demonstrated in several case~     studies of avulsion. To date no human clinical trials have been performed evaluating the~     effectiveness of PRF on pulpal revascularization after reimplantation and its benefits in~     limiting inflammation. The following study consists of two phases: Phase 1: An in vitro~     model evaluating the effects of PRF in limiting inflammatory response of pdl cell cultures~     in the presence of an inflammatory mediators. Phase 2: An in vivo model utilizing mature~     teeth previously treatment planned for extraction, treating with PRF, reimplanting teeth and~     following for three to four months before extracting and performing histological analysis.~     If PRF is capable of promoting revascularization in mature teeth the potential benefits~     extend to limiting the need for endodontic therapy following mature tooth avulsion,~     potential for mature tooth transplantation in situations of congenitally missing teeth, and~     utilization of PRF in endodontic revascularization therapy.~   "
44287|NCT02477345|"~     This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The~     protocol involves infants and children with parenteral nutrition-associated liver disease to~     enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).~   "
44288|NCT02477332|"~     This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and~     safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic~     Spontaneous Urticaria.~   "
44289|NCT02477319|"~     identify and validate biomarkers that might reflect partial restoration of CFTR function and~     can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR~     modulators and other relevant therapies in individuals with CF~   "
44290|NCT02477306|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Rabeprazole from Idiazole 20mg DR tabs (GSK, Egypt)and PARIET 20 mg DR~     tabs (JANSSEN, EGYPT) after a single oral dose administration of each to healthy adults~     under fasting conditions.~   "
44291|NCT02477293|"~     The purpose of this study is to evaluate the safety and effectiveness of~     Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean~     medicine.~   "
44292|NCT02477280|"~     Aim: The purpose of the study is to examine the effects of medication, placebo and~     expectation on objective and self-rated performance of ADHD core signs during the Quantified~     Behavior Test in patients with untreated ADHD and substance Use Disorders.~      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric~     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.~      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The~     study is taken place during four hours on two investigating days, separated by a 4 days~     wash-out period.~      All patients participate on two occasions: In one session they receive the Methylphenidate~     (MPH) condition, and in the other session they receive the placebo condition. MPH and~     placebo conditions are counterbalanced across subjects such that half of the participants~     receive MPH first, and half receive placebo first. Neither the patient nor the research~     assistant is aware when the participant receive the MPH condition or the placebo condition.~      On each investigating day the participant accomplish Questionnaires (Visual Analogical~     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise,~     (d) perceived help from the pill and (e) self-rated symptoms. In addition the participant~     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test~     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective~     information regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity~     measured with the camera, and inattention and impulsivity on basis of the CPT-test.~   "
44293|NCT02477267|"~     The primary objective of this study is to compare the bioavailability of a test formulation~     of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®~     (buprenorphine and naloxone) sublingual film, under fasted conditions.~   "
44294|NCT02477254|"~     To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE~     and healthy controls.~   "
44295|NCT02477241|"~     Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or~     without incontinence, usually with frequency and nocturia, with no proven infection or~     obvious pathology 1. This study will explore the relationship between OAB, obstruction and~     the micro contractions as well as the brain areas involved in both normal desire to void and~     urgency, gaining a better understanding of the bladder pathophysiology and in the future~     allowing better strategy of treatment options for patients suffering from OAB.~   "
44296|NCT02477228|"~     Endoscopic sphincterotomy is now an established method for removal of common bile duct~     calculi and treatment of papillary stenosis, the sump syndrome and certain cases of~     ampullary carcinoma. It is also generally performed prior to biliary stent placement~     .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal~     diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult~     common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation~     can be enhanced slightly by using the various accessories designed for this purpose.The aim~     of this study is to prospectively compare conventional approach and needle knife fistulotomy~     in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography~     regarding procedure-related complications as failure of cannulations, bleeding and~     perforation and postoperative complication~   "
44297|NCT02477215|"~     This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that~     are associated with an acceptable adverse event profile when delivered together in 28-day~     cycles. Additionally, the study aims to assess the efficacy of the combination in patients~     with relapsed/refractory multiple myeloma. Responders (stable disease or more), will~     continue to receive up to 8 cycles total in the absence of further progressive disease.~   "
44516|NCT02474550|"~     This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL)~     treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will~     prospectively collect clinical data and treatment outcome of patients with DLBCL who use~     prophylactic pegylated-filgrastim.~   "
44298|NCT02477202|"~     Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk~     of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a~     large extent through COCs ability to reduce cell proliferation in the fallopian tube~     fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an~     increasingly popular method of contraception, but it is not known if its use will reduce a~     woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release~     sufficient progestin to also reduce cell proliferation in the FTF. This study aims to~     evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible~     biomarker of protection against IEOC.~   "
44299|NCT02477189|"~     This is a retrospective evaluation of all subjects who successfully received implantation of~     the Silicone Block for correction of soft tissue deformities of the penis. In addition,~     subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing~     satisfaction with the implant and any adverse events that may not have been reported to the~     physician.~   "
44300|NCT02477176|"~     The purpose of this 12-month, prospective, multicenter study is to investigate the effect of~     annular defect size and other risk factors on reherniation and associated costs in primary~     lumbar discectomy patients.~   "
44301|NCT02477163|"~     The purpose of this study is to determine the effect of multi-dimentional ayurvedic~     treatment in the patients of various types of chronic kidney disease.~   "
44302|NCT02477150|"~     To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.~   "
44303|NCT02477137|"~     The purpose of this study is to evaluate the effects of an interactive ICT-platform for use~     in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The~     hypothesis is that clinical management will be improved and costs reduced and safe and~     participatory care promoted, when patients report symptoms in an application which provides~     self-care advice and instant access to professionals.~   "
44304|NCT02477124|"~     The purpose of this study is to see if the transvaginal colposcope produces similar results~     to colposcopy for the screening of cervical cancer. In this study the investigators are~     using an investigational device called the transvaginal colposcope. The word investigational~     means that the device is still being tested in research studies and is not approved by the~     U.S. Food and Drug Administration (FDA).~   "
44305|NCT02477111|"~     INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the~     study is to continue to evaluate the safety and effectiveness/performance of Incraft in~     subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical~     practice. Approximately 150 subjects will be enrolled and followed through 5-years~     postprocedure. Up to 25 sites in Europe may participate.~   "
44306|NCT02477098|"~     Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing~     abdominal surgery with a midline incision. It has proved to be effective in preoperative~     block, but it has not been previously compared with postoperative block. The aim of the~     present study is to evaluate postoperative pain, sleep quality and changes in the cytokine~     levels of patients undergoing gynaecological surgery with RSB performed preoperatively~     versus postoperatively.~   "
44307|NCT02477085|"~     Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from~     national population-based cohorts. The study aims to assess the frequency of different~     induction methods used in France from a prospective population-based cohort of women with an~     induced labor. Maternal, fetal and neonatal outcomes will be compared between the different~     induction methods. Moreover the adhesion to national clinical guidelines concerning the~     induction of labor will be studied from this population-based cohort.~      Finally the women satisfaction will be assessed according to the induction method used.~   "
44308|NCT02477072|"~     Hypothesis: Optimal anticoagulation defined as an Activated Clotting Time (ACT) of 300 to~     350 seconds obtained by weight-adjusted doses of unfractionated heparin (UFH) will improve~     the hemostatic environment downstream from the vascular clamp, provide better blood flow in~     the distal bed following peripheral revascularization surgery.~      Objectives: This study is designed to assess the effects of an optimized regimen of UFH on~     the hemostatic environment downstream from the vascular clamp in major vascular surgery.~   "
44309|NCT02477059|"~     Hand osteoarthritis (HOA) which affects the interphalangeal joints and the~     metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30~     % of the population over than 70. Some forms of HOA are refractory to usual treatments~     (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in~     vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is~     to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and~     function in patients with refractory hand OA.~   "
44310|NCT02477046|"~     The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace~     trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine~     (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community~     level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral~     transmission (duration of circulation, degree of genetic reversion) and the persistence of~     environmental contamination are unknown. Also unknown is the impact of the change from tOPV~     to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with~     monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an~     individual child if type 2 fecal shedding will be limited by cross-protection from oral~     vaccination with Sabin type 1 and 3.~      The investigators propose to measure at a community level transmission of Sabin 2 virus in~     Bangladesh, a low income country, where fecal-oral transmission and environmental exposures~     are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV.~     The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized~     study design. Villages in Matlab will be randomly assigned to receive as part of routine~     immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10,~     14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks.~     Community and environmental surveillance for Sabin 2 virus will be conducted in each village~     over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will~     occur 9 months into the study to model an outbreak response. For the 6 months following the~     mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in~     the community will be determined, as well as individual level protection (as measured by~     fecal shedding from days 7-70 after mOPV2 challenge).~   "
44311|NCT02477033|"~     During this project the safety, tolerability and effect on gut microbiota of oral~     administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers~     by a placebo-controlled cross-over randomized study.~   "
44312|NCT02477020|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063~     compared with placebo in treatment of acutely exacerbated schizophrenia.~   "
44315|NCT02476981|"~     This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored~     anaesthesia care (MAC) during minimally invasive corrections of vertebral compression~     fracture (vertebroplasty (VP) and kyphoplasty (KP)).~      In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received~     remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple~     hemodynamic variables of patients were recorded and the frequency of oxygen desaturation,~     respiratory depression, intraoperative need for other opioids, recovery time, operator~     satisfaction score, and patients' overall pain experiences were also compared.~      The investigators are expecting that both remifentanil and dexmedetomidine appear to be~     quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC~     during VP and KP in elderly patients.~   "
44316|NCT02476968|"~     This is a prospective, open-label, single arm, multi-center study to assess the real world~     clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule~     formulation (in line with the EU approved prescribing information) and will be conducted in~     platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including~     patients with primary peritoneal and / or fallopian tube cancer) who carry germline or~     somatic BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be~     deleterious or suspected deleterious [known or predicted to be detrimental/lead to loss of~     function]).~   "
44317|NCT02476955|"~     An Open-label Phase 1b Study of ARQ 092 in Combination with Carboplatin Plus Paclitaxel, in~     Combination with Paclitaxel, or in Combination with Anastrozole in Subjects with Selected~     Solid Tumors~   "
44318|NCT02476942|"~     This non-interventional study will prospectively collect detailed, high-quality~     documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without~     FVIII inhibitors treated according to local routine clinical practice (receiving FVIII~     replacement or bypassing agents as either episodic or prophylactic treatment). Actual~     patients will be enrolled from routine clinical practice in this observational study.~   "
44319|NCT02476929|"~     Introduction: Rhinitis, sinonasal polyposis (SP) and asthma are diseases whose pathogenesis~     is based on inflammation. This will determine the presence of disease, its evolution and its~     treatment. It is therefore very important to develop and validate methodologies that allow~     us to noninvasively detect inflammation of the airways. Thus, just as exhaled nitric oxide~     (FeNO) has been studied as an important non-invasive marker of inflammation of the lower~     airways, nasal nitric oxide (nNO) may be a good marker of nasal inflammation. Furthermore,~     the electronic nose is an electronic nanosensor device capable of detecting specific~     volatile organic compounds (VOCs) that can be used as a non-invasive biomarker of~     biochemical processes in different diseases whose pathophysiology is also based on~     inflammation.~      Objective: To determine reference values of nNO and different patterns of VOCs in healthy~     individuals, individuals with allergic rhinitis (AR) and non-allergic rhinitis and~     individuals with SP and asthma.~      Methodology: Prospective, controlled study. Four groups will be included: Healthy subjects,~     patients with AR, non-allergic rhinitis and patients with SP and asthma (n=252). Prick-test~     to pneumoallergens will be performed. Determination of FeNO, nNO, lung function tests,~     measurement of VOCs by the electronic nose and blood samples will be taken. Bilateral nasal~     endoscopy and sample collection using the technique of brushing of mucosa and the placement~     of filter papers, for the study of nasal cytology and mediators of inflammation.~   "
44320|NCT02476916|"~     Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of~     different dose levels of AG-348 in patients with PK deficiency.~   "
44321|NCT02476903|"~     Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the~     number of cases performed yearly. With hip arthroscopy still in its infancy in relation to~     knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms~     that were once thought to be true regarding indications and treatment for hip arthroscopy~     are continually being revised. As with the knee and shoulder before it, the hip is now~     graduating into treatment avenues that were otherwise thought to only be possible through an~     open surgical procedure.~      Viscosupplementation in patients post arthroscopy with known articular cartilage injury has~     been shown to be efficacious. The pathophysiology of hyaline degradation during the~     arthritic process within the knee has been studied, and with this understanding has grown~     the widespread usage of viscosupplementation. While questions still exist regarding the~     effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits~     seen in the weight bearing joints, such as the knee, are apparent~   "
44322|NCT02476890|"~     This is a double-blind, randomized, 2 period, crossover study in up to 36 healthy and~     chronic cough subjects.~   "
44323|NCT02476877|"~     The prevalence estimates for specific mental disorders and illicit drugs have been~     separately reported in U.S. government surveys. Less is known about the rates for specific~     comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance~     abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The~     effects that different demographic characteristics (ethnic background, family medical~     history, age, living conditions [e.g., living with a single parent]) have on the prevalence~     of comorbid mental illness and substance abuse also have not been considered. More should be~     known about the duration of substance abuse in different mental illnesses among those~     undergoing treatment, and whether specific types of drugs are associated with specific~     mental illnesses.~      In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence~     rates for the specific comorbid conditions and demographic relationships described above.~     This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from~     1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression,~     bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the~     Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for~     both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples~     will be collected at three time points: 1) immediately after enrollment and obtaining~     informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the~     study (6 months).~   "
44324|NCT02476864|"~     A study conducted in healthy adults to investigate if a new macitentan tablet leads to the~     same fate of macitentan in the body (time of onset, time of presence, amount in the blood)~     as the marketed macitentan tablet.~   "
44326|NCT02476838|"~     The purpose of this study is to see if an investigational surgery that transfers tissue from~     a non-living donor to living individual will help restore greater function, appearance, and~     sensation to the hand and forearm areas of individuals who have suffered traumatic injury to~     the hand and forearm.~      This procedure is called a hand allotransplantation or hand transplant.~      This study will also collect data on how patients do during and after having a hand~     transplant from a nonliving donor. Recovery and outcomes will be observed through clinical~     exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up~     visits.~   "
44327|NCT02476825|"~     This is a randomized, single-blind, controlled, single centre bronchoscopy study designed to~     assess the effects of fluticasone propionate on airway gene expression and cellularity in~     healthy adult controls without asthma.~   "
44328|NCT02476812|"~     Investigators will conduct a randomized controlled trial of a 30-day positive activities~     intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior~     to their scheduled appointment to undergo epidural steroid injection, all patients meeting~     study criteria will be contacted by research staff to be invited to participate in this~     study. Those interested will be asked to arrive 45 minutes before their regularly scheduled~     appointment. At that time they will learn more about the study and provide informed consent~     if they choose to participate. Participants will then complete the study questionnaires and~     be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control~     group (n = 100). All participants will receive the usual treatment provided at the Back &~     Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance~     of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months~     after that (Day 90), participants will complete the same questionnaires by mail. The primary~     outcome will be improved functional status, while secondary outcomes will be symptomatic~     (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period,~     the patients in the Wait List control will be offered the Positive Piggy Bank intervention~     and will be asked to complete one more set of questionnaires at 30 days by mail.~   "
44329|NCT02476799|"~     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative~     analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic~     surgery is accompanied by significant postoperative pain and usually IV-PCA is used to~     manage the pain.The purpose of this study is to investigate the analgesic effect of~     ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site~     at umbilical area. Patients will randomly assigned to two groups, RSB group and Control~     group. Each patients will assessed for time to first rescue analgesia, verbal numerical~     rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by~     IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.~   "
44330|NCT02476786|"~     Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can~     be identified. These trials have also demonstrated that there are not adverse effects on~     overall outcome if women are treated with neoadjuvant endocrine therapy for several months~     prior to definitive treatment. A new standard of care needs to be defined for elderly women~     with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from~     endocrine therapy alone to treat their cancer without compromising local and distant~     control. The investigators hypothesize that endocrine therapy alone provides adequate local~     and systemic control of breast cancer in a subpopulation of women 75 or older with ER+~     breast cancer and low Ki67 scores.~   "
44331|NCT02476773|"~     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator~     americanus hookworm life cycle that are thought to play a role in the parasite's degradation~     of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1~     has protected dogs and hamsters from infection in challenge studies. This study will~     evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy~     Brazilian adults living in an area of endemic hookworm infection.~   "
44332|NCT02476760|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated~     with an increased risk of acute pancreatitis (AP) compared to other combinations of oral~     hypoglycemic agents (OHA).~      The investigators will carry out separate population based cohort studies using~     administrative health databases in six jurisdictions in Canada, the US, and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for AP. The results from the~     separate sites will be combined to provide an overall assessment of the risk of AP in users~     of incretin-based drugs and by class of incretin-based drugs.~   "
44333|NCT02476747|"~     The investigators will investigate the efficacy of EMR compared to CSP in treatment of small~     colon polp (6~10mm).~      One aim of this study was to investigate the necessity of EMR on resection of small colon~     polyp.~   "
44334|NCT02476734|"~     In this study the investigators would like to describe FDG-PET/CT responses in patients who~     are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell~     Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will~     undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan~     at about 1 month after infusion.~   "
44335|NCT02476721|"~     The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to~     shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging~     procedures performed for other purposes. (1) Depending on the clinical presentation, the~     case fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often~     non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is~     often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms~     associated with pulmonary embolism, together these symptoms are responsible for~     approximately 10 million emergency department visits in the United States of America (US)~     (2). The aim of this study was to determine the sensitivity and specificity of diagnosing~     pulmonary embolism (PE) at the emergency department (ED) of the University Hospital Basel~     and the investigators have therefore retrospectively analyzed all cases with excluded or~     proven PE in our institution in the last three years. Data sets from the institute of~     radiology, the institute of pathology and the ED are consistently available from January~     2011 until the present day and were screened for pulmonary embolism in discharge reports.~     Data from the ED include all patients between January 2011 and December 2013 that presented~     to the ED and received either an ECG or any form of thoracic imaging. Particular attention~     was paid to patients with PE in the discharge report. The third set of data includes all~     patients with PE as cause of death or as a secondary diagnosis in the autopsy report. After~     comparing the three sets of data to each other the investigators tried to determine the~     sensitivity and specificity of PE diagnosis at the ED respectively the rate of missed~     diagnoses. A PE was seen as missed if it is detected 24h after the patient presented to the~     ED or if it was detected at another department after the patient was transferred from the~     ED.~   "
44336|NCT02476708|"~     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot~     clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The~     primary aim of this pilot trial is to provide an effect size estimate for the efficacy of~     curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to~     determine the effect of curcumin over time on negative and positive symptoms, in association~     with inflammatory markers.~   "
44337|NCT02476695|"~     This prospective and multicenter study is to determine the diagnostic performance (accuracy,~     specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis~     assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the~     reference.~      Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and~     ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of~     cirrhosis), respectively. For each stage, the case is assigned as equally as possible.~   "
44338|NCT02476682|"~     The purpose of this study is to determine the clinical utility of stool and blood~     methylation tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated~     polyps (SSP).~   "
44339|NCT02476669|"~     Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong,~     Taiwan, Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV).~     Radiation therapy alone is indicated for early stage I to II diseases while concurrent~     chemoradiation is required for more advanced stage III to IVB diseases. Intensity-modulated~     radiation therapy (IMRT) is the standard radiation technique for NPC, in virtue of its~     superior target coverage and dose sparing to adjacent critical organs-at-risks.~      Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC.~     Previous studies have proven their predictive and prognostic values in NPC diagnosis,~     surveillance and survival outcomes.~      We would like to investigate the roles of plasma biomarkers including plasma EBV DNA on~     treatment response evaluation, survival and prognosis on NPC, in the modern era of precision~     radiation therapy.~   "
44340|NCT02476656|"~     Objective of study is to explore expression of stress-related genes and inflammation in~     placentas and umbilical cord blood for women participating in group prenatal care compared~     with women receiving individual prenatal care.~   "
44341|NCT02476643|"~     Thi study aims to test, if a two-week integrative therapy in an internal medicine ward will~     improve symptoms, disability and quality of life in patients with inflammatory bowel disease~     or irritable bowel syndrome. It shall further be tested, if those changes are associated~     with attitudes and experiences towards complementary and alternative medicine, anxiety,~     depression and stress perception as well as body awareness and responsiveness.~   "
44342|NCT02476630|"~     Oxygen concentration for patients undergoing cardiac catheterization and during admission to~     an intensive care unit is important outcome measure for clinical care. Currently, the tool~     used to monitor the oxygen concentration is a central venous access positioned in the~     superior vena cava or in the pulmonary artery to monitor the central venous oxygen~     saturation (ScvO2). However, it is invasive and not always possible due to a lack of a~     central line access. In this research study, the investigator would like use a noninvasive~     means for the ScvO2 by using the thenar tissue oxygen concentration (StO2). The primary aim~     for the study is to determine if the thenar StO2 correlates with ScvO2 and can serve as a~     noninvasive surrogate for ScvO2.~   "
44343|NCT02476617|"~     A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic~     HCV GT1a treatment-naïve and pegylated-interferon (pegIFN)/RBV treatment-experienced adults~     receiving treatment with ombitasvir/ABT-450/ritonavir and dasabuvir coadministered with RBV~     for 12 weeks.~   "
44344|NCT02476604|"~     It is widely acknowledged that cardiovascular disease prevention requires intervention as~     early in the human lifespan as practical. A window of opportunity presents in early~     adulthood when students gain independence as young adults attending university. In a~     three-phase investigation, this study will evaluate the behavioral patterns of university~     students in the domains of diet, exercise, stress management, smoking and sleep (phase 1).~     Informed with information from phase 1, a pilot study (phase 2) will test the feasibility of~     performing an intervention in university students consisting of an 8-week period during~     which the students will receive up to six text messages (by phone or iPad) per week,~     tailored to address the behavioral issues that the student has identified as needing~     improvement and for which the student has indicated a desire to make change. Using lessons~     learned in phase 2, a randomized, controlled trial of the 8 week intervention (phase 3) will~     compare intervention subjects with controls for outcomes of behavior change, measures of~     anthropometric data, and serum markers of cardiovascular risk to test the impact of the~     intervention~   "
44345|NCT02476591|"~     To investigate the effects of the availability of daily patient-related charges on ordering~     patterns of health care ordering providers and cost containment in the Intensive Care Unit~     (ICU) setting.~   "
44346|NCT02476578|"~     The purpose of this study is to determine whether alerting primary care providers by email~     about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall~     survival and other health indexes of people older than 75 years.~   "
44347|NCT02476565|"~     The investigators plan to conduct a randomized trial comparing the efficacy of intubating~     the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel~     supraglottic devices~   "
44348|NCT02476552|"~     This is an open-label study with 2 parts, plus an extension study following completion of~     Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6~     subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and~     absolute bioavailability of niraparib.~   "
44349|NCT02476539|"~     The purposes of this study are to assess the safety, tolerability and pharmacokinetics of~     Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the~     treatment of HER2-positive advanced breast cancer.~      The study will be conducted in two parts. Part one, trial will be conducted in 18-30~     subjects to determine safety and tolerability of Hemay022 in patients with HER2-positive~     advanced breast cancer. Part two, approximately 27 additional subjects with HER2-positive~     advanced breast cancer, are included to better define the tolerability and preliminary~     efficacy of Hemay022.~   "
44350|NCT02476526|"~     The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio~     contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients~     with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in~     comparison to a similar group of patients with CKD who receive no contrast medium..~   "
44351|NCT02476513|"~     In this study,the investigators will evaluate participants that have clinical features~     associated with an increased risk of esophageal disorders.The investigators will also see if~     there is a positive association of esophageal disorders in men,40-60 with or without~     abdominal obesity in the diagnosis of the following diseases; Gastroesophageal reflux~     disease, Barrett Esophagus and Esophageal Adenocarcinoma. The investigators hypothesize that~     most obese patients referred for Esophagogastroduodenoscopy will exhibit esophageal~     disorders. Since currently the rates of obesity and adenocarcinoma of the esophagus have~     increased significantly over the past 15 years, the investigators hope to find biochemical~     markers (i.e. pro-inflammatory mediators) in the esophagus. The investigators hope these~     samples will lead us to a differential expression of molecular markers and inflammatory~     mediators in the varying degrees of esophageal disorder~   "
44352|NCT02476500|"~     In a prospective case-control study, 140 medical students (,novices') and 10 Senior~     gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone~     (LLETZ) on a Training model afte having undergone a Video Training session. Their~     LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical~     Skills (OSATS) protocol designed for judging the surgical proficiency when performing a~     LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training~     model to distinguish between experts and novices will be assessed. Secondary endpoints are~     differences in OSATS scores within the group of novices based on gender and handyness, as~     well as satisfaction of the novices with the learning experience.~   "
44353|NCT02476487|"~     Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals,~     with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB,~     other than in cases of Infective endocarditis (IE), recommended by different guidelines~     relies on risk stratification for relapse of infection rather than definite diagnosis of~     septic foci that eventually determine the relapse rate. In recently published studies~     fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying~     metastatic infectious foci in Gram-positive bacteremia, including SAB.~      Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE~     SAB compared to standard treatment recommendations on treatment duration and clinical~     outcomes.~      Methods: A prospective interventional non-comparative cohort study conducted at Rambam~     Health Care Campus. Patients with SAB, defined as microbiologically and clinically, will~     undergo FDG PET CT 10-14 days following the first positive blood culture for diagnosis of~     septic extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks)~     versus long treatment (4-6 weeks) will be recommended for negative and positive PET CT~     tests, respectively. Patients will be followed-up for 1 year for relapse of infection and~     mortality.~      We will document the sensitivity and specificity of PET CT for detection of complications~     among patients with SAB. We will examine the percentage of patients in whom the use of PET~     CT changed treatment duration compared to standard recommendations. We will compare also,~     the relapse rate and 1 year mortality rate with data from previous studies and local data.~     Assuming a 15% rate of management changes compared to consensus recommendations, a sample of~     150 patients will achieve the required 95% CI.~      Significance: Our trial will serve for improving decision making in patients with non-IE~     SAB, shortening treatment duration in unnecessary cases and decreasing relapse rate by~     giving prolonged appropriate treatment for metastatic infection not identified by standard~     management algorithms. PET CT is assuming an increasingly important role in infection~     diagnosis and management. The current study will be the first to examine the role of PET CT~     in directing management of patients with SAB.~   "
44354|NCT02476474|"~     Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a~     narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus~     (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric~     emptying, particularly for solids. Hence, depending upon the starting point of gastric~     sleeve resection in each center, this can result in difference of the remaining gastric~     antrum which may affect gastric emptying time after this procedure.~   "
44355|NCT02476461|"~     The purpose of this study is to investigate whether percutaneous needle fasciotomy is as~     effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be~     investigated, as iskontracture size after 5 years. Contracture size after one and three~     years, and subjective hand function is also to be investigated.~   "
44356|NCT02476448|"~     This study evaluates 4 different methods to aid surgeons visualize ureteral jets on~     cystoscopy.~   "
44357|NCT02476435|"~     The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic~     stimulation in patients with depersonalization disorder.~   "
44358|NCT02476422|"~     The study is designed to assess the efficacy and tolerability of diclofenac potassium soft~     gelatin capsules compared with ibuprofen tablets in patients with moderate to severe~     postoperative dental pain.~   "
44359|NCT02476409|"~     Patients who present to clinic or in the outpatient setting with worsening heart failure~     represent a unique opportunity for novel approaches to decongestion (removing fluid) that~     may more rapidly improve fluid status and symptoms as well as reduce the risk of~     hospitalization.~      In these patients with less severe congestion (fluid overload), combining the vasopressin~     antagonist tolvaptan with loop diuretics (or fluid pills like~     furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion.~     In addition, looking at patients' copeptin levels may help identify those who are more~     likely to respond to tolvaptan.~   "
44360|NCT02476396|"~     The purpose of the research is to understand structural plaque abnormalities that make a~     carotid plaque unstable and brake off (embolize) which would help to predict and treat~     individuals who are likely to suffer not only classic episodic major strokes but also~     cognitive impairment.~   "
44361|NCT02476383|"~     This study considers whether treatment effects in response to spinal manipulative therapy~     for individuals experiencing low back pain are dependent upon the context in which the~     intervention is provided. Half of the participants will receive spinal manipulative therapy~     with encouragement to interact with the provider and information to enhance expectations for~     the effectiveness of the intervention. The other half will receive spinal manipulative~     therapy with minimal interaction with the provider.~   "
44362|NCT02476370|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing Herniotomy.~   "
44363|NCT02476357|"~     Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion~     lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma~     or breast cancer were randomized in a controlled trial for surgical dissection technique.~     Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and~     oedema.~   "
44364|NCT02476344|"~     2 young candidates have tragically died during army pre-recruitment sorting series in 2006.~     As part of the classification and characterization of the physical aspects of the training,~     this experiment was requested.~      We aim at determining the characteristics of physical strains in sorting series, by~     objective and subjective parameters and evaluating the difficulty levels and intensity of~     those strains.~   "
44365|NCT02476331|"~     Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation.~     Mood changes are episodic in nature, with distinct periods of mania, depression, and~     asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments~     are a common feature of the disorder. These cognitive impairments persist during periods of~     euthymia and are associated with negative clinical and psychosocial outcomes. Specifically,~     individuals with BD show impairments in executive functions. Recent studies show that~     emotion regulation can be down-regulated by taxing executive functions, and it can be~     improved with working memory training, a specific component of executive functions. These~     initial studies show that emotion regulation is under executive control in healthy~     individuals; however, the nature of this relationship is not well understood in populations~     that are affected by impairments in both executive control and emotion regulation. Previous~     work on cognitive training has not targeted specific cognitive domains with an emphasis on~     understanding the underlying mechanisms that promote change. Moreover, well-controlled~     randomized control trial (RCT) studies are needed in order to provide high quality evidence~     to inform the efficacy of cognitive training interventions for psychiatric populations. The~     aim of the proposed study is to use a commercially available cognitive training program to~     study the effects of working memory training on cognitive, clinical, and psychosocial~     outcomes in patients with BD. We hypothesize that training working memory will lead to~     improvements in cognitive and emotional functioning, leading to downstream changes that will~     positively impact untrained outcomes, such as mood and community functioning.~   "
44366|NCT02476318|"~     A prospective, multi-center study to evaluate the safety and performance outcomes of the~     ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the~     anastomosis between native vessel and synthetic vascular grafts.~   "
44367|NCT02476305|"~     Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from~     musculoaponeurotic structures. Although they are benign tumors with no metastatic potential,~     DT are considered as locally aggressive tumors, with local invasiveness and tissue~     destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but~     is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall,~     root members). In patients where surgery is considered, negative-margin resection (R0) is~     recommended, but this frequently results in cosmetic/functional impairment. Moreover,~     prognostic impact of R0 resections remains controversial. The outcome after initial surgery~     depends upon several factors such as age, tumor site, and tumor size as demonstrated by~     recent data from the French Sarcoma Group.~      Alternative therapies to DT surgery for front-line or recurrence include NSAID's,~     anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or~     radiation therapy. All of these medical approaches however may fail to achieve long-term~     disease control and a number of patients suffer from irreducible pain, and disability from~     tumor volume.~      Cryoablation is a promising technique that is suitable for patients experiencing~     extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of~     the tumor, leading to cell death. The technique has many advantages, among which: the~     accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible~     with other techniques such as radiofrequency), the lack of mutilation, the possibility of~     repeating the procedure. The cryoablation procedure has proven to be beneficial for the~     treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous~     cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with~     promising results.~      In the light of these encouraging data, it is believed that patients with extra-abdominal DT~     not amenable to surgery unless unacceptable surgical sequel and progressing after at least~     two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from~     the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms~     relief, prolonged progression-free survival and a better quality of life.~   "
44368|NCT02476292|"~     The purpose of this study is to learn about the impact of vasculitis on employment and~     income in patients with different systemic vasculitides. All patients enrolled in the~     Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or~     Canada, and followed for more than 1 year since the vasculitis diagnosis will be invited via~     email to participate in this study, based on an online survey.~   "
44369|NCT02476279|"~     Background: Pancreatitis is the most frequent complication of endoscopic retrograde~     cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality,~     and increased health care expenditures. Until recently, the only effective method of~     preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement~     (PSP), an intervention that is costly, time consuming, technically challenging, and~     potentially dangerous. The investigators recently reported the results of a large randomized~     controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory~     drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%)~     had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who~     received indomethacin alone were less likely to develop PEP than those who received a~     pancreatic stent alone or the combination of indomethacin and stent, even after adjusting~     for underlying differences in subject risk. If indomethacin were to obviate the need for~     PSP, major clinical and cost benefits in ERCP practice could be realized.~      Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of~     rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP~     pancreatitis in high-risk cases.~      Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin~     alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement~     for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four~     hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic~     stent for prophylaxis will be randomized to indomethacin alone or the combination of~     indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will~     be compared. In addition, the investigators will establish a quality-assured central~     repository of biological specimens obtained from study participants, permitting future~     translational research elucidating the molecular and genetic mechanisms of PEP, as well as~     the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.~   "
44370|NCT02476266|"~     Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a~     multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls~     are commonly experienced in PD.The purpose of this study is to investigate the effects of~     two different resistance training programs on improving balance and muscular strength to~     thereby reduce the risk of falls in those with PD. This study will randomize individuals to~     one of two groups, a power training group, or a strength training group. Both interventional~     groups will participate in 12 weeks of resistance training, two times per week for an hour~     each exercise session.~   "
44371|NCT02476253|"~     The purpose of the present study is to compare the adjunct treatment of metabolic or mixed~     severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the~     plasma pH vs no buffering therapy.~      The study is a randomized multiple center clinical trial with the outcome as a primary~     endpoint.~   "
46381|NCT02449915|"~     To determine if the injection of liposomal bupivacaine to laparoscopic port sites and~     rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant~     rectocele repair will result in decreased postoperative pain compared to injection of~     placebo.~   "
44372|NCT02476240|"~     The purpose of this study is to evaluate the underlying mechanism and influence of~     externally vs. internally focused exercise on rehabilitation in Parkinson's disease. The~     upcoming exercise intervention methodology will aim to meet the requirements of a 1A silver~     ranking level, single blind, randomized control trial according to the criterion of the~     Cochrane Musculoskeletal Review Group~   "
44373|NCT02476227|"~     Catheter ablation in the treatment of atrial fibrillation (i.e. pulmonary vein isolation) is~     now the most effective method of prevention of arrhythmia recurrence. Use of 3D~     electroanatomical system is now a golden standard.~      Background hypothesis is that automatic algorithm collecting ablation points during~     pulmonary vein isolation (with certain catheter stability time, range of motion, and~     catheter-tissue contact force) prevents forming the gaps in the ablation line, thus~     preventing pulmonary vein reconnection and AF recurrence. The aim of the trial will be 1:1~     comparison of the two methods of pulmonary vein isolation: with manual vs. automatic~     collection of ablation points using CARTO system and contact force catheter.~   "
44374|NCT02476214|"~     Prenatal care is defined as pregnancy-related health care services provided to a women~     between conception and delivery. Early, comprehensive prenatal care can promote healthier~     pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing~     preexisting medical conditions, by providing health behavior advice, and by offering a~     gateway into the health care system for socially disadvantaged women . The customary~     approach for prenatal care includes routine individual care, which is provided by nurses and~     physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been~     entitled to health care services according to the National Health Insurance Law . Israeli~     citizens are covered by National Health Insurance, and get maternal and child preventive~     services including prenatal care by local Mother and Child Health Clinics . The prenatal~     care is individual. A nurse meets with every registered pregnant women, assess the medical~     and emotional condition and provide guidance related to the pregnancy week of the woman.~      Since the 70, a number of group prenatal care intervention programs are described in the~     literature. Group prenatal care is designed to answer the recommended content for prenatal~     care for improving the quality of care and resulting in improved pregnancy outcome . The~     group prenatal care includes three important components: risk assessment. Guidance and~     support and combines them into the prenatal care22. Creation of the group provides a meeting~     place for pregnant women. A safe place for sharing and learning from each other and to build~     a community for mutual support .~      The investigators hypothesize that, relative to women who receive standard individual~     prenatal care, the women who receive group prenatal care will be more likely to:~        1. Report higher levels of satisfaction. The investigators also anticipate higher levels~          of staff satisfaction within the intervention group medical staff.~        2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors~          during pregnancy, tests during pregnancy).~        3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT,~          first and second trimester screening, US)~        4. have better perinatal outcomes: better health behaviors during pregnancy (e.g.,~          nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low~          birthweight,), and better postpartum indicators (e.g., increased breastfeeding);~   "
44375|NCT02476201|"~     The purpose of the study is to assess prospectively at 6 months the percentage of responder~     patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet~     Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature~     activated.~   "
44376|NCT02476188|"~     The purpose of the study was to investigate the correlation between the nucleosome~     concentration and the rate of recanalization after thrombolysis. All patients were admitted~     to the Stroke Unit at the University Hospital Sainte-Anne where they received standard~     stroke care. The investigators included all patients treated or not by intravenous~     thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion~     criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of~     stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before~     admission.~   "
44377|NCT02476175|"~     The objective is to evaluate the efficacy and safety of adding mirabegron to an~     antimuscarinic to treat urinary incontinence in children with Overactive Bladder that are~     refractory to antimuscarinics.~   "
44378|NCT02476162|"~     Second malignant neoplasms and cardiac late effects are primary drivers of serious~     non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late~     effects have been most prominently associated with exposure to high doses of anthracyclines~     or chest radiation. While increased recognition of late effects has resulted in~     risk-targeted therapy and reductions in use of high dose radiation and anthracyclines for~     many patients, these cardiotoxic exposures continue to be essential components of curative~     childhood cancer therapy. In addition, as survivors age they are increasingly susceptible to~     other general risk factors for cardiovascular disease recognized in the general population,~     such as hypertension, obesity, dyslipidemia, and diabetes.~      This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the~     early detection of pre-hypertension and prevention of clinical hypertension in survivors of~     childhood cancer. Eligible and consenting participants will be randomized into one of three~     groups:~      GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2:~     Instructed to measure BP for 7 consecutive days once a month, for 3 months.~      GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3~     months.~      The randomization to the above groups will be done using sequential assignment of newly~     recruited participants based on a randomly ordered list.~      PRIMARY OBJECTIVE:~        -  Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive~          months using a remote blood pressure device provided to participants of the St. Jude~          Lifetime cohort (SJLIFE) protocol.~      SECONDARY OBJECTIVES:~        -  Assess compliance with use of HBPM by measurement frequency, evaluating overall and~          defined minimum use in each of the three different groups.~        -  Assess compliance with use of HBPM by cell phone status, evaluating those with and~          without a personal cell phone capable of connecting directly to the home blood pressure~          monitoring device via Wi-Fi or Bluetooth network.~   "
44379|NCT02476149|"~     In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular~     astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by~     an intricate collagen network, which is responsible for its shape and function. In KC this~     collagen network is disrupted resulting in the cornea losing its shape and function.~     Keratoconic changes are focal and localised to certain regions of the cornea and the early~     detection of these changes is challenging. Screening methods include corneal topography~     (evaluation of anterior corneal surface curvature), tomography (assessing the morphological~     features of the anterior segment) and aberrometry (measuring the optical aberrations of the~     eye). More recent research suggests that the biomechanical destabilization of the cornea may~     precede topographic and tomographic evidence of KC. Management of KC depends on disease~     severity with severe cases being treated with keratoplasty and less severe cases with~     cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the~     biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the~     biomechanical properties in human corneas following CXL, there is a significant need for~     accurate measures of biomechanical changes in vivo pre and post CXL. Until recently~     technical limitations have restricted the ability to assess the biomechanical properties of~     the whole cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible~     to assess regional biomechanical behaviour of the cornea. The output from the device~     provides a variety of parameters to indicate the cornea's biomechanical strength. To date,~     the association between the deflection behaviours in various regions of the cornea in~     keratoconic eyes preand post CXL has not been studied. In order to effectively assess the~     clinical benefits of CXL such information is vital. The primary goal of this investigation~     is to investigate regional biomechanical properties of the keratoconic eye before and after~     CXL.~   "
44388|NCT02476032|"~     The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter &~     Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips~     (Procter & Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the~     investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter~     & Gamble™) effectiveness when the product is placed by a dental professional compared to~     self-placement by the person with sensitive teeth. This product is not experimental.~   "
44389|NCT02476019|"~     The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of ISIS-FGFR4RX.~   "
44380|NCT02476136|"~     Anxiety disorders are common disorders, which pose a major burden to society and the~     individual. An anxiety disorder may be treated with medication, in particular with~     antidepressants such as the selective serotonin reuptake inhibitors (SSRIs). However, much~     of what is known about antidepressants is derived from research in depression rather than~     anxiety. In recent years, researchers have found that antidepressants are more effective for~     severely depressed patients than they are for patients with milder symptoms. It is possible~     that a similar relationship between symptom severity and antidepressant efficacy exists for~     anxiety disorders, but there is currently little evidence available to answer this question.~     As antidepressants are frequently prescribed to patients with mild or moderate anxiety, a~     clear understanding of their effectiveness across the severity range is vital to inform~     treatment decisions. Therefore, the purpose of this meta-analysis is to examine whether~     initial symptom severity affects antidepressant efficacy for anxiety disorders.~   "
44381|NCT02476123|"~     The purpose of this study is to characterize the safety and tolerability and determine the~     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of~     Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.~   "
44382|NCT02476110|"~     Hypothesis : At hospital discharge for home, the medical prescription of ONS according to~     the official criteria of SSNC and the legal regulations (completed prescription according to~     health's insurance and homecare delivery) dictates the compliance of the patient and the~     reimbursement of the ONS.~   "
44383|NCT02476097|"~     Objectives:~      To compare the prevalence of clinical symptoms of stomach problems between patients with~     progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those~     with sudden discontinuation of esomeprazole 40mg. The presence of clinical symptoms, as~     reported in the modified-Proton Pump Inhibitor Acid Suppression Symptom Test (PASS) test~     will be weekly assessed until 4 weeks after the inclusion.~      Study design:~      This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by~     esomeprazole 40mg since 4 weeks or more, randomized to 1 week of placebo or one week of~     esomeprazole 20mg.~      The first day of the study (Day 0), three blood samples will be collected at fast to measure~     chromogranine A (CgA), gastrinemia, and Helicobacter Pilory (HP) serology. Cytochrome P450~     (CYP)2C19 activity will be assessed.~      Then, at Day 1, the patients will receive esomeprazole 20mg or placebo for 7 days (Day1-8).~      Participants will complete the PASS test once a week on the same weekday throughout the~     study (Day8-D15-D22-D29), during a telephone interview or a consultation, if it was~     scheduled in the clinical follow up of the study.~      Duration of treatment:~      Esomeprazole or placebo for one week (Day1-8) Omeprazole single dose (Day0) Time plan of~     research~      Duration for the patient:~      The treatments will stop after 7 days. The questionnaires will be collected until the 4th~     week, Day29.~      Overall duration of inclusion: one year Maximal overall duration of the study: 365 days+29~     days=394 days Maximal delay for communication of the results: 2 years~   "
44384|NCT02476084|"~     The purpose of this study is to determine the kinetics of change in quantitative measures of~     joint inflammation by state of the art power Doppler vascular imaging and to identify~     biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine~     and stool samples) from parallel cohorts of RA patients undergoing different treatments.~     This will be achieved implementing MSUS assessments, standard laboratories techniques (such~     as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.~   "
44385|NCT02476071|"~     The study, funded by the Bill and Melinda Gates Foundation, will test a novel demand~     generation strategy, Stylish Man, to increase uptake of safe voluntary male circumcision~     (VMC) for HIV in Rakai, Uganda. With President's Emergency Fund for AIDS Relief (PEPFAR)~     funds, the Rakai Health Sciences Program (RHSP) provides VMC in Rakai District, Uganda. The~     investigators' ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV~     prevalence ranging from 6% to 42%, provides longitudinal data on rates of VMC coverage and~     on HIV incidence. The investigators have preliminary evidence that VMC is reducing HIV~     incidence in Rakai, but coverage remains suboptimal (as elsewhere in Africa), reducing~     program impact. The investigators' data suggest that VMC supply is not the limiting~     factor, but that there is a deficit in demand.~      Based on extensive qualitative research, the investigators have developed and piloted an~     innovative male-focused VMC demand generation strategy, the Stylish Man Program (SMP). The~     VMP strives to demedicalize VMC by de-emphasizing health-focused messages and instead~     stressing taking charge of your life. The SMP has two distinct but related elements: (1)~     mass media (MM) via radio and posters; and (2) community-level mobilization via the Stylish~     Man Event (SMEvent) which includes multimedia media (the Stylish Van, videos, music, health~     promoters) into which the investigators have embedded VMC promotion, and immediate access to~     services. In this study, the investigators will conduct a one year cluster randomized trial~     of MM plus SMEvents (intervention arm) compared to MM alone (control), in 20 RCCS~     communities, half randomzied to the intervention and half to the control arm.~      The primary outcome will be intent-to-treat community-level rates of VMC coverage by arm,~     ie., the percentage of non-muslim men in each arm who accept and adopt MMC. (Over 95% of~     Muslim men in Rakai already receive male circumcision in infancy.) As secondary outcomes, we~     will also monitor rates of key behaviors and HIV incidence, and compare them between arms~     and to rates observed in communities in each arm prior to study initiation.~   "
44386|NCT02476058|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in~     participants with Major Depressive Disorder (MDD).~   "
44387|NCT02476045|"~     Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of~     non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone~     (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A)~     following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and~     panitumumab in patients with RAS wild-type, metastatic colorectal cancer.~      The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the~     dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.~      Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be~     immediately randomized electronically 1:1 to one of the two maintenance arms. Induction~     treatment with FOLFOX-4 plus panitumumab will continue until progressive disease,~     unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of~     induction treatment, in presence of complete or partial response, or stable disease,~     non-progressing patients will be allocated to one of the two pre-assigned maintenance arms:~      A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until~     progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab~     alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or~     informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be~     performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during~     treatment.~   "
44390|NCT02476006|"~     Primary Objective:~      To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular~     (CV) events and not adequately controlled with currently available lipid-modifying therapy~     (LMT) access to alirocumab ahead of commercial availability and to document the overall~     safety and tolerability of alirocumab in this patient population.~      Secondary Objectives:~      To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol~     (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after~     12 weeks of treatment.~      To document patient's acceptability of self-injection (Self Injection Assessment~     Questionnaire, SIAQ).~   "
44391|NCT02475993|"~     The purpose of this study is to test a web-aided, mobile-based PHR (Personal Health~     Reporting) service to enhance SCD outpatient treatment after discharge from an acute care~     setting, such as Duke University Medical Center's Day Hospital. SMART is a new mobile~     application created by SickleSoft to increase patient involvement in their treatment and~     improve patient to doctor communication. SMART is a self-monitoring and management service~     for SCD patients and their treatment doctors. This study will test whether or not use of the~     SMART mobile application will help develop the type of patient-doctor relationships that~     lead to better health outcomes and a decrease in readmission to an acute care facility.~   "
44392|NCT02475980|"~     The purpose of this pilot study is to determine the feasibility of comprehensive~     contraceptive counseling intervention in a pediatric emergency department and to determine~     the impact of comprehensive contraception counseling on initiation of contraception among~     sexually active adolescents presenting to a pediatric emergency department.~   "
44393|NCT02475967|"~     In the trial cardiac patients will be provided with unrestricted access to the web-based~     eLearing platform for a one-month period.~   "
44394|NCT02475954|"~     When Veterans with Parkinson's disease (PD) suffer from depression, they are more likely to~     experience disease complications, interpersonal difficulties with caregivers, and poorer~     quality of life. Unfortunately, depression in Veterans with PD is inadequately treated at~     the current time. Treatment for depressed Veterans with PD will require the elimination of~     geographical barriers to care and approaches that address the unique aspects of PD. The~     proposed study will be the first to explore a novel and innovative, PD-informed~     psychotherapy package for depressed Veterans with PD and their Caregivers, delivered through~     video-to-home telehealth. If the results of this proposal are promising, a much needed~     treatment can be made available to Veterans with PD and their Caregivers across the country,~     regardless of geographical location.~   "
44395|NCT02475941|"~     The investigators will be looking at geriatric distal femur fractures. The investigators~     will prospectively enroll these patients and allow patients to either weight bear as~     tolerated or limit their weight bearing post operatively. The investigators will evaluate~     functional outcomes.~   "
44396|NCT02475928|"~     The purpose of this study is to evaluate the effect of zinc supplementation in the treatment~     for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.~   "
44397|NCT02475915|"~     This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion~     of patients between:~      Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral~     therapy (ART) Group 2: ART only who are able to maintain HIV RNA < 50 copies/ml following~     treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV~     infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand.~     The study will run for a minimum of 34 weeks from screening.~   "
44398|NCT02475902|"~     The participants will complete a series of balance assessments with a licensed physical (PT)~     or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co~     or in their respective homes at the start of the study, at crossover and upon completion of~     the study. During this study a PT, OT, or RA trained in fall risk management will supervise~     the instruction and practice by participants of the home exercise programs during the~     initial 2-3 hour introduction to the study activities. Participants will be asked to~     exercise 3/week for one month then crossover to the alternative exercise program and~     exercise 3/week for a second month.~   "
44399|NCT02475889|"~     It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human~     carcinoma. However, there are insufficient studies on the immune modulation of tumor~     microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME~     in human cancer patients, investigators performed a retrospective study of a unique cohort~     of patients who suffered from synchronous CRCLM.~   "
44400|NCT02475876|"~     Developmental changes in physiology during childhood influence drug dosing. Failure to~     account for these changes leads to improper dosing, which is associated with decreased drug~     efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK)~     modeling offers the opportunity to predict optimal drug dosing based on physiologic~     parameters adjusted for developmental changes.~      PBPK models are mathematical constructs that incorporate physiologic processes with drug~     characteristics and genetic variances to characterize the dose-exposure relationship across~     the age continuum. These models integrate drug-specific (e.g., metabolism, protein binding)~     and systems-specific (e.g., organ size, blood flow) information to predict the effect of~     different factors (e.g., age, genetic variants, disease) on drug exposure. By accounting for~     these factors and using data from clinical trials to confirm the modeling, PBPK models can~     reduce the number of children needed for clinical trials while maximizing dose-based~     efficacy and safety.~      This trial will evaluate a platform to prospectively validate population PBPK models in~     children. The study drugs, clindamycin and Bactrim (aka TMP-SMX), are ideal candidates to~     evaluate population PBPK models in children due to their differing physico-chemical~     properties and elimination pathways. In addition, a trial of clindamycin and TMP-SMX has~     broad clinical applicability, as both drugs are among the most commonly used agents to treat~     gram-positive infections in infants and children.~   "
44401|NCT02475863|"~     This study compares the clinical effectiveness of a new algorithm (model-based warfarin~     dosing) with standard practice (doctor's own judgement and intuition) designed to determine~     the most appropriate anticoagulant dose of warfarin in children after congenital heart~     surgery.~   "
44403|NCT02475837|"~     The Objectives of this study are:~        1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional~          maturation when administered during the maturation process compared with placebo.~        2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary~          procedures to aid in fistula maturation compared with placebo.~        3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for~          hemodialysis compared with placebo.~      This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be~     conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will~     be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health~     Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The~     investigators expect to enroll 128 patients. Patients will be assigned to treatment groups~     with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.~     Patients will be stratified based on fistula location (lower arm versus upper arm).~   "
44404|NCT02475824|"~     This is a single-center, prospective, randomized, double-blinded study of consecutive~     patients referred for ERCP. A recent study suggested that the addition of dexmedetomidine to~     the midazolam-meperidine regimen (MMD)provided better sedative efficacy and a superior~     safety profile during ERCP compared with a midazolam-meperidine regimen. Further study is~     warranted to compare an MMD regimen with propofol-based regimen.~      Randomization is performed by use of a computer-generated random allocations in a ratio of~     1:1 in balanced blocks of 4. A separate sedating nurse, who don't participate in the study,~     is the only person with knowledge of the sedation regimen. This separate nurse repeated the~     injection of propofol and completed questionnaires.~   "
44405|NCT02475811|"~     One hundred healthy women with singleton pregnancies in the 1st stage of labor will be~     included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37~     weeks) & Group B (n: 50 - women pregnant ± 37+1-40 weeks). A 3D volume model of the right~     fetal lung is generated & lung volume is calculated using VOCAL software. After child birth,~     neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min)~     together with occurrence of RDS and the further need for NICU admission and respiratory~     support measurements.~   "
44406|NCT02475798|"~     The purpose of this extended study is to collect confirmatory safety and effectiveness data~     on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the~     commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac~     aneurysms.~   "
44407|NCT02475785|"~     The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance~     with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular~     effects while preventing the excessive proclination of the lower incisors at the end of the~     treatment when compared to the conventional Forsus Fatigue resistant Device appliance~     applied to the upper and lower dental arches in female patients with skeletal Class II~     malocclusion~   "
44408|NCT02475772|"~     Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal~     chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of~     the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4~     weeks for three courses using a three-group, dose-escalation protocol with fixed~     dose-density. The time Frame for the assessment of the Primary outcome is therefore 12~     weeks. Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The~     study hypothesis is that local and systemic toxicity will increase with increasing dosage of~     cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5~     events in any treatment group.~   "
44409|NCT02475759|"~     Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized~     controlled trial.~   "
44410|NCT02475746|"~     The purpose of this study is to evaluate the effect of itraconazole after multiple dose~     administration on the single dose PK of PF-06372865.~   "
44411|NCT02475733|"~     This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam~     and metronidazole versus meropenem in paediatric population (from 3 months to less than 18~     years of age )with complicated intra-abdominal infections (cIAIs)~   "
44412|NCT02475720|"~     According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is~     all over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension.~     However, the real situation and the reason are not clarified.This observational study~     collects the data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical~     record of approximately 20 facilities in Japan and observes the treatment reality of EGFR~     gene mutation-positive NSCLC.~   "
44413|NCT02475707|"~     This research study uses special blood cells called multiple tumor-associated antigen~     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute~     lymphoblastic leukemia (ALL) which has come back, or may come back, or has not gone away~     after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT).~      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin~     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in~     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This~     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are~     able to hide from the body's immune system and escape being killed. The investigators~     previously tested whether special white blood cells (called T cells) that were trained to~     kill EBV-infected cells could affect these tumors, and in many patients the investigators~     found that giving these trained T cells caused a complete or partial response.~      In several lymphomas and other types of cancers like ALL, the cancer cells do not have EBV.~     They do however express specific proteins that can be targeted in the same way. The~     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with~     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment~     appears to be safe. Therefore, the investigators now want to test whether the investigators~     can direct these special T cells against other types of cancers that carry similar proteins~     called tumor-associated antigens (TAAs). These proteins are specific to the leukemia cell,~     so they either do not show up, or show up in low quantities, on normal human cells.~      The investigators will grow T cells from patients' stem cell donors in the laboratory in a~     way that will train them to recognize the tumor proteins WT1, PRAME and Survivin, which are~     expressed on most ALL cancer cells. The cells will be infused at least 30 days~     post-allogeneic stem cell transplant. In this study, the investigators want to see whether~     these cells will be able to recognize and kill leukemia cells that express these antigens.~     These donor-derived multiTAA-specific T cells are an investigational product not yet~     approved by the U.S. Food and Drug Administration.~      The purpose of this study is to find the largest safe dose of donor-derived~     multiTAA-specific T cells for patients with ALL.~   "
44414|NCT02475694|"~     The purpose of the present study is to visualize the inflammatory response and coagulation~     disorders during cardiac surgery in order to identify possible predictors for acute lung~     injury postoperatively.~   "
44415|NCT02475681|"~     This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil~     compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of~     previously untreated chronic lymphocytic leukemia (CLL).~   "
44423|NCT02475577|"~     The study will test a hypothesis that the remote monitoring with text and email alerts sent~     to study subject and optional family/other caregiver (Intervention 1) will have a higher~     return on investment compared to remote monitoring with nurse researcher follow-up telephone~     communication to study subject (on Blue alerts) or study subject's healthcare professional~     (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).~   "
44424|NCT02475564|"~     This study aims to verify whether the use of 40 mg of resveratrol per day associated with~     monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces~     pelvic pain at the end of 2 months of treatment, compared to the use of the pill with~     placebo.~   "
44425|NCT02475551|"~     This study will assess the safety and efficacy of IdeS in the transplantation setting. Each~     patient will receive one dose of IdeS. If the crossmatch test is negative at the time of~     transplantation, the patient will be transplanted with a kidney from a deceased or living~     donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior~     to surgery.~   "
44426|NCT02475538|"~     This study aims to examine the efficacy of electroacupuncture for tapering benzodiazepines~     in long-term users. All eligible subjects will be randomized in a ratio of 1:1 to (1)~     Electroacupuncture combined with gradual tapering; and (2) Placebo acupuncture combined with~     gradual tapering.~   "
44427|NCT02475525|"~     The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement~     in the prevention of wound complications in the the wounds of patients post lower limb~     revascularization.~   "
44428|NCT02475512|"~     Incontinence is a widespread problem in all health care setting. One of the main~     complications of incontinence is inflammation of the skin in the genital and anal region,~     also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of~     pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.~      The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe~     versus standard care (traditional water and soap) for the prevention of IAD. The second aim~     is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care,~     and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for~     total body wash. Other outcomes are the comfort and tolerance of both the nurses and~     participants.~      In this Randomized Controlled Trial, performed in 13 long-term care settings, the~     participants will undergo a 30 day study period. In the experimental intervention, the~     participants will be washed with body wash wipes and genital wipes. In the control group,~     the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be~     monitored. Subjective and objective time measurements will be performed.~   "
44429|NCT02475499|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone in or combination with other anti-diabetic drugs are associated~     with an increased risk of pancreatic cancer (PC) compared to sulfonylureas.~      The investigators will carry out separate population based cohort studies using~     administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for PC. The results from the~     separate sites will be combined to provide an overall assessment of the risk of PC in users~     of incretin-based drugs and by class of incretin-based drugs.~   "
44430|NCT02475486|"~     Despite the large therapeutic arsenal available since one decade allowing a strong reduction~     of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep~     problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy~     is lower than the strong reduction in RA disease activity. Furthermore, RA patients have~     higher prevalence of non-inflammatory pain than general population. Fatigue is a real major~     problem due to 50% of patients considered it as severe.~      This dissociation between disease activity and fatigue level suggests that fatigue is~     multifactorial. No consistent explanations for fatigue are currently available.~   "
44431|NCT02475473|"~     Study the responses of circulatory irisin to chronic high-intensity resistance training~   "
44432|NCT02475460|"~     The purpose of this study is to evaluate a less invasive implantation technique of the~     HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.~   "
44433|NCT02475447|"~     Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is~     an orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in~     several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the~     safety, tolerability and clinical efficacy of asimadoline in patients with pruritus~     associated with atopic dermatitis.~   "
44434|NCT02475434|"~     At present, widespread use of the human milk-based caloric supplement (cream) has not~     occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data~     are needed to support its adoption as a standard care practice.~      The investigators hypothesize that infants who receive an exclusive human milk (HM)-based~     diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a~     shorter length of initial hospital stay compared to infants receiving the standard regimen~     of an exclusive HM-based diet (Control group). The investigators hypothesize that the~     effects of the cream caloric supplement will be greater in the subgroup of infants who~     develop BPD so the relationship will be evaluated between Cream Supplement study group and~     postmenstrual age (PMA) at discharge and the incidence of BPD.~   "
44435|NCT02475421|"~     The study aims to evaluate the elimination and degradation of glucagon in patients with type~     2 diabetes compared to matched healthy subjects.~   "
44448|NCT02475252|"~     In a prospective case-control study, the investigators compare the Objective Structured~     Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts~     performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators~     hypothesize that OSATS on a hysteroscopy training model has construct validity to~     discriminate between experts and novices.~   "
44449|NCT02475239|"~     The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo~     is the canalith repositioning procedure or the Epley maneuver. Based on the present~     literature, there is controversy on the efficacy of post-maneuver postural restrictions.The~     aim of this study was to conduct a randomized controlled trial to compare the treatment~     efficacy of post-maneuver postural restriction with CRP alone in patients with posterior~     semicircular canal benign paroxysmal positional vertigo.~   "
44436|NCT02475408|"~     Coronary artery disease and the benefit of bypasses:~      Despite considerable advances in medicine, cardiovascular diseases remain the number one~     cause of death globally, primarily consequence of myocardial infarction (MI). Coronary~     collaterals exert a protective effect by providing an alternative source of blood flow to a~     myocardial territory potentially affected by an acute coronary occlusion. Coronary~     collaterals represent pre-existing inter-arterial anastomoses and as such are the natural~     counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown~     to confer a significant benefit in terms of overall mortality and cardiovascular events. In~     this regard, the concept of augmenting coronary collateral function as an alternative~     treatment strategy to alter the course of CAD, as well as to control symptoms, is~     attractive.~      Durable promotion of coronary collateral circulation:~      Before the advent of coronary artery bypass grafting, permanent augmentation of coronary~     collateral supply by a single structural modification has already been attempted. Bilateral~     ligation of the internal mammary arteries (IMA) was performed in CAD patients to alleviate~     angina pectoris and electrocardiographic (ECG) signs of ischemia. The prevalent in vivo~     function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for~     the first time - been recently demonstrated by our research group. The acute functional~     changes observed in response to temporary distal IMA balloon occlusion are expected to~     result in larger chronic structural adaptations of the IMA-to-coronary-artery connections~     when the distal IMA is permanently occluded. In contrast to the previously employed~     arteriogenic approaches in humans, the attractiveness of such an intervention lies in the~     potential durability of the effect.~      In a first step, catheter-based IMA occlusion ought to be conceptually investigated in the~     setting of the less frequently grafted right IMA among patients with ischemia in the right~     coronary artery territory.~   "
44437|NCT02475395|"~     The objective of the study is to evaluate the agreement in measurement of sperm~     concentration in human semen between lay users with TRAK and a recognized reference method.~     The study will also include the measurement of matched samples by TRAK when tested by~     healthcare professionals trained in use of the TRAK device.~   "
44438|NCT02475382|"~     The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal~     antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic~     treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell~     lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is~     appropriate.~   "
44439|NCT02475369|"~     The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic~     enzyme supplementation will improve symptoms in individuals with celiac disease who suffer~     persistent symptoms despite a gluten free diet. This protocol specifically aims to:~        1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of~          gastrointestinal symptoms in patients with celiac disease on a gluten free diet.~        2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme~          supplementation in patients with celiac disease on a gluten free diet.~   "
44440|NCT02475356|"~     The primary objective in this study is collecting post-marketing information on the safety.~     Thus, it includes information under the routine clinical practice on adverse events (AEs)~     and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur~     within the first 12 months Mirena insertion.~      The secondary objective(s) in this study is/are collecting information on Mirena~     effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and~     dysmenorrhea pain as far as these are recorded under routine clinical practice.~   "
44441|NCT02475343|"~     This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties.~     The administration of Schiotz tonometer is according to the routine protocol which is use to~     measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared~     with results obtained from ORA and/or Corvis.~   "
44442|NCT02475330|"~     This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS)~     supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung~     cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during~     the course of radiation treatment. Study participation and surveillance will last~     approximately 6 months. Subject specimen collection will include: blood, urine, and buccal~     swabs at 5 time points.~   "
44443|NCT02475317|"~     The purpose of this study is to assess the relative potency of multiple oral doses of LUM001~     and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight~     and obese adult subjects. This study is designed to address the relative potency question~     for the first time in the same.~   "
44444|NCT02475304|"~     The purpose of this study is to investigate, whether FP187 is effective in the treatment of~     mild to moderate psoriatic arthritis.~   "
44445|NCT02475291|"~     Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary~     angiography to assess the potential of a coronary stenosis to induce myocardial ischemia.~     Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress~     imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional~     manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of~     FFR for all angiographically significant stenoses would add considerable time, cost, and~     complexity to each PCI procedure and might also increase the risk of catheter-related~     complications such as coronary dissection and perforation. Although the guideline mentioned~     that FFR may not be useful in very high grade lesions (angiographically >90%) which always~     have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80~     obtained by angiographic parameters including degree of stenosis, lesion location and vessel~     size. It would be valuable to find more precise criteria available by conventional~     angiography for discrimination of functional stenosis in way to reduce the risk of~     additional procedure. For the purpose, the investigators will perform FFR in the lesions~     with significant stenosis (>70% diameter stenosis by visual estimation) and compare the~     angiographic parameters and FFR values in the study.~   "
44446|NCT02475278|"~     The purpose of this study is to collect serum samples to evaluate serologic assays and to~     establish proficiency panels for serologic assays used for assessment of post vaccination~     immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent~     virus-like particle (VLP) vaccine.~   "
44447|NCT02475265|"~     Decreased bone strength is a common and serious medical problem present in many women with~     anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones~     than women with normal bone strength.~      This study will investigate whether the use of transdermal estrogen can improve bone mineral~     density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa~     when used for 6 months.~   "
44450|NCT02475226|"~     Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality.~     In this study of cases being treated in the ICU for a diagnosis of brain damage, it was~     aimed to evaluate the relationship between mortality and the distribution of reason for and~     resulting type of brain damage and to determine other factors affecting mortality.~   "
44451|NCT02475213|"~     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination~     with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma,~     squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC),~     and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of~     enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also~     be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and~     to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab.~   "
44452|NCT02475200|"~     The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry~     sponsored by Volcano Corporation to evaluate the short and long term performance and~     clinical outcomes of the Phoenix Atherectomy System.~   "
44453|NCT02475187|"~     Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events~     over 2 years in 220 patients with hip fracture.~   "
44454|NCT02475174|"~     Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous~     circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy~     breast cancer.~   "
44455|NCT02475161|"~     The purpose of this study is to assess the effects of daily administration of rabeprazole on~     the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.~   "
44456|NCT02475148|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-54175446~     versus placebo after single oral dose administration (ascending dose levels), to determine~     the maximal tolerated dose (MTD) or the safety and tolerability at exposures resulting in~     full target engagement for at least 24 hours in all participants (whichever comes first), to~     characterize the pharmacokinetics of JNJ-54175446 in plasma, cerebrospinal fluid (CSF) and~     urine and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics~     of JNJ 54175446 after single oral dose administration.~   "
44457|NCT02475135|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability~     of Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose~     combination (FDC) with darunavir (DRV) and cobicistat (COBI)~     (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) relative to~     administration as an FDC with Elvitegravir (EVG) and COBI~     (Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), under fed conditions in~     healthy subjects (Panel 1); evaluate the single-dose pharmacokinetics and relative~     bioavailability of DRV, COBI, FTC and TAF when administered as an FDC (D/C/F/TAF) or as~     separate agents (D+C+FTC/TAF), under fed conditions in healthy subjects (Panel 2) and to~     evaluate the impact of food (fasting or high-fat breakfast) on the single-dose~     pharmacokinetics of DRV, COBI, FTC, and TAF when administered as an FDC (D/C/F/TAF) in~     healthy subjects (Panel 3).~   "
44458|NCT02475122|"~     Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the~     time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is~     a life-threatening complication. The yearly incidence of the first variceal bleeding in~     cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large~     varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for~     patient with medium or large varices a primary prophylaxis treatment with nonselective~     beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico~     Hepatology 2005).~      The method to evaluate the efficacy of beta blockers treatment is the hepatic venous~     pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker~     treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response~     (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of~     patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at~     2 years.~      In this situation, alternative treatments to beta-blockers have been suggested: endoscopic~     ligation, which was shown to be as effective as beta blockers in primary prevention, and~     more recently carvedilol (Reiberger, Gut 2012).~      So, HVPG monitoring may provide critical information for patients. However, because of its~     technical requirement and its invasivity, HVPG measurement is not feasible in clinical~     practice . So, there is a general consensus to continue indefinitely beta blockers treatment~     without control of hemodynamic efficiency (merkel J. Hepatology 2009).~      Previous studies have suggested the interest of azygos blood flow measurements for~     evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal~     hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has~     been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology~     2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement.~      However, in the same way that HVPG, a large-scale implementation in clinical practice of~     azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or~     relative post-therapeutic decrease, related with no variceal bleeding.~   "
44459|NCT02475109|"~     The objective of this study is to assess the safety and tolerability of topical ocular~     PAN-90806 in patients with proliferative diabetic retinopathy.~   "
44460|NCT02475096|"~     This pilot-study aims to evaluate the effect size and feasibility of internet-delivered~     cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant~     functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal~     pain and functional dyspepsia according to the Rome III criteria). The main component~     investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli~     and situations. Children will participate along with one of their parents in the treatment.~     The parents will also receive specific modules with information on how to support their~     child in the treatment.~   "
44461|NCT02475083|"~     The aim of this study was to investigate the therapeutic effect of virtual reality~     associated with conventional physiotherapy on balance during gait and the occurrence of~     falls in patients after stroke.~   "
44462|NCT02475070|"~     The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects~     on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2~     diabetes and whether this is associated with effects on glucose homeostasis.~   "
44463|NCT02475057|"~     The purpose of this study is to test whether Degarelix is associated with less endothelial~     dysfunction (an intermediate in the development of cardiac disease) and cardiovascular~     biomarkers compared to LHRH agonists.~   "
44464|NCT02475044|"~     The purpose of this study is to investigate the role of psychosocial factors in creating~     Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses:~     (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do~     socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution~     for the child injury by their parents and (2) embracing of a more permissive and~     authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does~     Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral~     symptoms?~   "
44465|NCT02475031|"~     The purpose of this study is to determine whether continuous transversus abdominis plane~     (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor~     nephrectomy~   "
44468|NCT02474992|"~     The purpose of this randomized controlled trial is to compare a social network-based~     behavioral intervention known as microclinics to standard HIV clinical care alone in helping~     patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to~     clinic appointments. The study is designed to evaluate the effectiveness of microclinics on~     reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard~     HIV clinical care alone. By doing this research study, the investigators hope to learn~     whether microclinics are a useful social strategy for improving delivery of HIV treatment in~     rural Kenya.~   "
44469|NCT02474979|"~     Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable~     costs for society. The present study will evaluate the effect of the Continuous Bedside~     Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients~     will be conducted in a geriatric setting in a Swedish University hospital~   "
44470|NCT02474966|"~     The blood-brain barrier (BBB) is a specialized interface allowing a unique environment for~     neuro-glia networks. BBB dysfunction is common in brain disorders. The Transcranial Magnetic~     Stimulation (TMS) is a non-invasive method of stimulating cortical motor neurons with the~     use of rapidly changing electromagnetic fields generated by a coil placed over the scalp.~     The objective of this study is to evaluate the safety and effects of the deep TMS (dTMS) on~     barrier integrity in patients with malignant glial tumors. BBB permeability will be~     quantified using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).~     Permeability change will be compared between two DCE-MRI scans performed immediately after~     real and sham rTMS, randomly assigned within one week of each other.~   "
44471|NCT02474953|"~     This study is investigating the pharmacokinetic profile (i.e. the way the product is~     processed by the body) of a proprietary curcumin formulation compared to an unformulated~     curcumin product. Subjects will take a single dose of either the proprietary formulation or~     comparator product and the blood levels of curcumin and curcumin metabolites will be~     measured over a period of 48 hours.~   "
44472|NCT02474940|"~     People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, available~     treatments provide inadequate relief for the majority of these individuals. There remains an~     urgent need for additional treatment options for MS-related symptoms. The purpose of this~     study is to see if alternative treatments that involve self-hypnosis training, neurofeedback~     training and/or mindfulness meditation training, or a combination of some of these~     treatments can help decrease pain and fatigue in people with MS. A subject must have a~     diagnosis of MS, have chronic pain and/or fatigue, and be at least 18 years old to~     participate, among other criteria.~   "
44473|NCT02474927|"~     The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety~     and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous~     immunoglobulins for AMR after lung transplantation and elucidate important clinical and~     immunologic phenotypes and mechanisms associated with these outcomes.~   "
44474|NCT02474914|"~     pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign~     and malignant pancreatic and periampullary diseases. Despite improved surgical technique and~     postoperative care, the mortality rate after PD is high reaching up to 30%, due to high~     incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most~     frequent complications of PD and the major contributor to postoperative morbidity The aim of~     this study to evaluate the effect of the perioperative octreotide use after PD for~     prevention of the postoperative pancreatic fistula. The secondary outcomes are overall~     postoperative complications, mortality and the cost benefit relationship of the use of the~     perioperative octreotide.~   "
44475|NCT02474901|"~     The goal of this study is to determine if there is a difference in shedding (primary~     objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and~     HIV-negative children and young adults who are receiving the quadrivalent live-attenuated~     influenza vaccine (QLAIV).~   "
44476|NCT02474888|"~     The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels~     could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.~      All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or~     the relapse of a known ANCA-associated vasculitis, in which the decision to start an~     induction regimen with rituximab has been taken, will be included.~      Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be~     determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be~     analyzed.~   "
44477|NCT02474875|"~     Education of pain physiology is described as an educational session or sessions describing~     the neurobiology and neurophysiology of pain, and pain processing by the nervous system.~     There is compelling evidence that an educational strategy addressing neurophysiology and~     neurobiology of pain can have a positive effect on pain, disability, catastrophization, and~     physical performance in chronic musculoskeletal pain disorders. Although pain physiology~     education has been studied in patients with chronic low back pain, chronic whiplash, and~     chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM)~     are limited to a 2013 study with limited results.~      The investigators propose a study with a higher dose of education of pain physiology (i.e. a~     higher number of educational sessions and total education time) to study if this generates a~     larger treatment effect in patients with fibromyalgia.~   "
44478|NCT02474862|"~     This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP)~     in comparison to a Postpartum Prep Program (PPP) comparison group for pregnant women~     experiencing depressive symptoms. In addition to assessing changes in depressive symptoms,~     the investigators will examine other key maternal outcomes (maternal functioning, pain,~     anxiety, stress, fatigue), as well as infant outcomes including birth record data~     (gestation, weight, Apgar scores, etc) and careful, in-person assessment of infant~     neurobiological functioning at 30 days postpartum.~   "
44479|NCT02474849|"~     This study will compare nicotine delivery, heart rate, puffing parameters and product~     satisfaction in healthy subjects either using several different types of electronic~     cigarettes or smoking a conventional cigarette.~   "
44514|NCT02474576|"~     The efficiency of percutaneous aponeurotomy in the treatment of Dupyutrens disease is well~     known. However, the duration of the clinical improvement after aponeurotomy is not well~     known.~      This study aims primarily at measuring the incidence rate of local relapse of~     Dupuytrens-induced finger flessum, within two years following treatment by percutaneous~     aponeurotomy in Dupuytrens.~   "
44480|NCT02474836|"~     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. Many factors such as the variability, differences in~     extraction process and subsequent handling of allergens can affect the final composition,~     potency, and stability of allergen preparations. Genetic diversity of affected people adds~     another level of complexity. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. Therefore, the system for biological~     standardization mainly used in Europe still is the biological calibration of in-House~     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on~     Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick~     Test (SPT) value. The aim of this procedure is to estimate the biological activity of~     allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the~     extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked~     by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated~     using the same technique (prick testing) on at least 20 individuals who are sensitized to~     the allergen concerned.~      The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus~     acerifolia, Dermatophagoides farinae by using this method.~   "
44481|NCT02474823|"~     A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor),~     showed a positive maneuver (unable to wrap hands completely around neck) to be 100%~     predictive of sleep apnea in a sleep clinic population. The investigators now would like to~     compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics.~     The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and~     polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are~     scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along~     with two sleep questionnaires PSG. The screen test wil be compared to the results of the~     gold standard diagnostic test the PSG for their predictive value os OSA in the type 2~     diabetic population.~   "
44482|NCT02474810|"~     Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380~     hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of~     these catheters includes thrombosis and infection. Catheter locking solutions such as~     recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and~     prevent clotting of the catheter during HD treatments and during the interdialytic period.~     Evidence to guide the use of rt-PA is limited. This quality assurance project will compare~     the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol~     for rt-PA in HD patients.~   "
44483|NCT02474797|"~     Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim~     of this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction~     (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically~     ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction~     frequency, its prognosis value and its associated factors.~      This is a prospective pilot study in a 14-bed medical and surgical ICU including 50~     consecutive patients with severe sepsis or septic shock. The expected duration of study is~     18 months.~      DTF is measured each day as follow: the probe is placed in an intercostal space between mid~     axillary line and anterior axillary line, 0.5cm to 2 centimeters below the~     costodiaphragmatic sinus. DTF measure is performed in B-mode using the following formula: TF~     (%) = [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x~     100]. A DTF < 20% indicates a diaphragmatic dysfunction.~      The investigators will collect potential factors for which DTF Ultrasound Measure could have~     a prognosis value (intubation, successful or failed weaning from mechanical ventilation),~     potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors.~      The investigators expect measure of DTF allows identifying patient with severe sepsis or~     septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic~     dysfunction frequency with ultrasound measure and warranting its use routinely at the~     bedside. The investigators expect that DTF helps to characterize degree of severity of~     septic patient and can be a new index able to predict intubation in this population.~   "
44484|NCT02473718|"~     The purpose of the study is to determine if a protocol that assesses patients' daily fluid~     intake and output can decrease the overall amount of fluid patients receive during the first~     five days in the ICU. The study will also determine if decreasing overall fluids can~     decrease adverse events associated with mechanical ventilation, such as~     ventilator-associated pneumonias.~      The protocol will include daily ultrasounds and blood draws to evaluate fluid balance.~     Ultrasound will be used to measure changes in the diameter of the inferior vena cava with~     respiration.~   "
44485|NCT02473705|"~     The purpose of this research study is to study the effect of fish oil and bicarbonate~     (baking soda) on exercise. In this study fish oil, bicarbonate or both will be compared to~     placebo to see if study participants increase exercise capacity.~   "
44486|NCT02473692|"~     The present research will pilot-test a new state-of-the-art Internet-based intervention~     targeting adherence facilitation and optimization of medication use, and will be evaluated~     to assess its utility in facilitating adherence and optimization of medication use for acute~     migraine pharmacotherapy. This is not an interventional study and will instead be an~     observational assessment of the feasibility of an online program (a proof-of-concept study).~     The two principal objectives of this study include: (a) examination of the feasibility and~     user usage patterns of an Internet-based intervention designed to potentially enhance~     adherence to medication use recommendations, and (b) determination of the efficacy of the~     Internet-based intervention in potentially increasing knowledge of abortive medication-use~     guidelines and in improving adherence to those guidelines. To meet the objectives of this~     study, a website has been specifically developed including a series of supplemental~     text-based headache materials and a series of videos based social learning theory and~     modeling principles (as opposed to the stereotypical 'talking-heads' mode of information~     delivery).~   "
44501|NCT02474745|"~     The objective of this randomized clinical trial is to assess and compare the effectiveness~     of directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs.~     directed open-glottis pushing (pushing during a prolonged exhalation) during the second~     stage of labor. The study hypothesis is that open-glottis pushing results in better maternal~     and neonatal outcomes, in particular for maternal pelvic floor and continence function.~   "
44487|NCT02473679|"~     Cardiac arrest occurs frequently and the outcome after out-of-hospital resuscitation is~     often fatal. Disturbing is that more than half of the surviving patients suffer from~     permanent impairment of cognitive functions, such attention, memory and executive~     functioning. With all the efforts to achieve a high quality initial resuscitation management~     the time delay between cardiac arrest and the beginning the initial resuscitation maneuver~     is the main reason for the still poor outcome. To shorten this fatal time delay, current~     efforts of national and supranational health authorities aime at the non-medically trained~     lay person, who should carry out basic life support directly on the scene supported by the~     use of public available semi-automatic defibrillators (AED).~   "
44488|NCT02473666|"~     Study the influence of transfusion related Patient Blood Management Program actions on~     transfusion-related outcome measures and cost.~   "
44489|NCT02473653|"~     Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies~     try to assist a patient's immune system (a system in our bodies that protects us against~     infection) in killing tumors. One form of such therapy is the dendritic cell combined with~     HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are~     immune cells that can tell your immune system to fight infection. In laboratory testing,~     these cells may also help the immune system attack tumors such as breast, kidney cancer or~     skin cancer. The purpose of this research study is to determine if it is both possible and~     safe to administer this vaccine to patients with any HER2+ cancer.~   "
44490|NCT02473640|"~     A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the~     Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with~     a Functioning Ileostomy~   "
44491|NCT02473627|"~     This is an open-label, cross-over, fixed-sequence study. All subjects will receive the same~     treatment in two study periods. The study is designed to test whether DS-1971a has any~     effect on the activity of various enzymes involved in the metabolism of medicines, using~     test medications. These will be given without and then with DS-1971a to see if DS-1971a has~     any effect on the blood levels of the test medicines.~   "
44492|NCT02473614|"~     We are trying to determine the therapeutic effect of the music glove and conventional hand~     exercise program to patients with spinal cord injuries. All participants will be randomized~     into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with~     a minimal 3 hours exercise time per week. Participants will receive the other intervention~     at their 3 week post therapy follow up visits. Clinical evaluations will be performed at~     baseline 1 and 2 (3 to 10 days apart), post therapy after first intervention, 3-week post~     therapy follow up, post therapy after second intervention, and 3-week post second~     intervention follow up visits.~   "
44493|NCT02473601|"~     Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of~     mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed~     recovery phenomenon~   "
44494|NCT02473588|"~     A group of engineers at Michigan State developed a novel waveform analysis technique (Long~     Time Interval Analysis [LTIA]) that attempts to estimate cardiac output non-invasively.~     Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest~     acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares~     LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.~   "
44495|NCT02473575|"~     The purpose of this study is to determine whether caffeine gum improves the performance of~     runners completing free timed mass participation 5 km runs in the United Kingdom (UK)~   "
44496|NCT02473562|"~     The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive~     daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind,~     placebo-controlled clinical trial with a within-subject crossover design.~   "
44497|NCT02473549|"~     Many individuals are often left with problems moving their arm and hand, months to even~     years after a stroke. Recent progress in research suggests the application of non-invasive~     brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction~     with rehabilitation exercises can further improve a person's ability to move after stroke.~     However, the problem is that this doesn't work for everyone, and researchers do not know~     why. One reason may be that TDCS is currently applied using a one-size-fits-all approach.~     Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in~     the same way. But, researchers know this is not the case. For example, each person will~     likely have different amounts of damage to brain regions that control movements. A better~     understanding of how the stroke uniquely affects a person's brain will help us to know which~     is the correct type of TDCS to apply for that person. Therefore, the objective of this~     research is to determine whether the amount of damage to brain regions that control~     movements can predict which type of TDCS will be more effective to help a person improve~     their ability to move. Participants will undergo 1 session of magnetic resonance imaging,~     and three sessions of TDCS.~   "
44498|NCT02473536|"~     Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy~     fro kidney tumor and tumor thrombus~   "
44499|NCT02473523|"~     Researchers at St. Jude Children's Research Hospital want to investigate the feasibility of~     a yoga intervention for adolescents receiving treatment for lymphoma or leukemia.~     Adolescents who participate in the program may experience improved physical and psychosocial~     measures. Improvements in these areas may increase participation in meaningful activity and~     improve quality of life.~      Adolescents diagnosed with cancer may experience more fatigue, anxiety and pain during~     treatment. Yoga is considered a complementary alternative medicine (CAM) that has been~     implemented into some pediatric oncology rehabilitation programs and has been shown to be~     beneficial in both inpatient and outpatient settings. It may decrease anxiety and increase~     quality of life and hamstring flexibility in teens.~      PRIMARY OBJECTIVE:~        -  To determine the feasibility of yoga intervention for adolescents during lymphoma and~          leukemia treatment.~      OTHER PRE-SPECIFIED OBJECTIVE:~        -  To obtain pilot data regarding efficacy of yoga on pain, quality of life, fatigue and~          physical performance.~   "
44500|NCT02473510|"~     This prospective annual release study is designed to evaluate the safety of 3 new influenza~     virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza~     season~   "
44515|NCT02474563|"~     The purpose of this study is to assess the 2-year progression-free survival rate.~   "
44502|NCT02474732|"~     FDA requires that the user's guide be provided with any over-the-counter (OTC) medical~     device. It is beneficial to demonstrate that the user's guide for a new medical device is~     broadly comprehensible where the device will be provided without prescription and direct~     physician counseling. Therefore, a population of subjects will be tested to determine~     whether they can properly use the BeActive Brace device after reading the user's guide.~   "
44503|NCT02474719|"~     The aim of this study is to demonstrate the efficiency of an adapted and alternate~     peritoneal dialysis scheme in terms of sodium extraction and purification compared to an~     adapted conventional peritoneal dialysis scheme.~   "
44504|NCT02474706|"~     Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing~     Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and~     cross-transmission in healthcare establishments. These give rise to major problems in~     standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to~     the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole,~     is very frequently observed. The current therapeutic strategy involves the use of a~     carbapenem, which represents the last effective solution on an individual level. However,~     the growing use thereof is contributing, collectively, to the development of resistance due~     to the production of carbapenemases, which will become a major public health problem, with a~     potential therapeutic dead-end. This observation is particularly worrying due to the very~     small number of antibiotic agents currently in development.~      Infectious disease specialists and microbiologists are thus examining alternative agents to~     carbapenems in the management of infections caused by ESBL-producing E. coli. One of the~     avenues which could be developed is the use of known agents, already on the market, which~     are active in vitro on ESBL-producing E. coli, but which are not currently recommended for~     this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an~     antibiotic belonging to the cephamycin group, could thus represent an alternative of~     particular interest in the treatment of infections caused by ESBL-producing E. coli, and~     help limit the use of carbapenems.~      The implementation of a prospective, randomized, non-inferiority study on ertapenem and~     cefoxitin is of the most interest from a methodological perspective. It will enable~     recommendations to be drawn up, with a high level of evidence, very long-awaited in the~     field.~      Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus~     imipenem in the treatment of non-severe urinary tract infections (other than cystitis)~     caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.~      Secondary objectives:~        -  To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment~          of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing~          E. coli susceptible in vitro to cefoxitin.~        -  To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant~          bacteria in the gut flora.~   "
44505|NCT02474693|"~     The Centers for Disease Control and Prevention conducted an observational cross-sectional~     study to obtain information about the amount of sodium consumed from various sources~     (including sodium from processed and restaurant foods, sodium inherent in foods, and salt~     added at the table and during cooking) and to examine variability across population~     subgroups. Data collection will include an observational component as well as a sub-study~     designed to refine the accuracy of estimates of total sodium intake and discretionary sodium~     intake.~      Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul,~     Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a~     study center in each location recruited 150 participants (total N=450). Overall, an~     approximately equal number of adults ages 18-74 years by approximately 10-year age groups in~     each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was~     conducted among a subgroup of 150 of these participants (50 per site). University of~     Minnesota serves as a study coordinating center.~   "
44506|NCT02474680|"~     This is a non-randomized, single-case design of pharmacogenetic implementation in a mental~     health patient population of subjects taking antipsychotics and/or antidepressants.~   "
44507|NCT02474667|"~     A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of~     BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor~     Kidney.~      The major objective is to demonstrate the safety and efficacy of BB3 in reducing the~     severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a~     deceased donor renal allograft.~   "
44508|NCT02474654|"~     Study question: Is there an ideal combination of intraoperative long acting analgesics~     (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to~     optimize post-operative functional recovery, decrease overall narcotic consumption and~     enable faster 'readiness to discharge' for patients undergoing primary total knee~     replacement (TKR)?~   "
44509|NCT02474641|"~     Hypofractionation with simultaneous integrated boost has been investigated in a few trials~     and appears to be safe and feasible.~      Investigators initiated this multicenter two-armed phase III prospective trial to analyse~     the non-inferiority of hypofractionation with simultaneous integrated boost in patients with~     early breast cancer in comparison to standard fractionation.~   "
44510|NCT02474628|"~     Intervention studies do not account for high within-individual variation potentially~     compromising the magnitude of an effect. Repeat administration of a treatment allows~     quantification of individual responses and determination of the consistency of responses.~     The investigators aim to determine the consistency of metabolic and exercise responses~     following repeated administration of sodium bicarbonate (SB). Design and Methods: 15~     physically active males will complete six cycling capacity tests at 110% of maximum power~     output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or~     placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at~     baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be~     recorded as the exercise outcome.~   "
44511|NCT02474615|"~     Thirty teeth twelve patients, two female and a male, who had persistent periradicular~     lesions were selected to participate in this study. The lesions were diagnosed with~     cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences~     International LLC).In patients with two teeth to be treated, a tooth was retroobturado with~     PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control).~      There was significance for the two cements on the repair of wounds. Key words: Apicoectomy;~     Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research~   "
44512|NCT02474602|"~     The effects of phototherapy has been widely studied by some research groups. The~     investigators know that there are positive results with light application to improve muscle~     performance and delay fatigue. However, there are few studies showing its´ effects on~     muscular training. Therefore, the aim of this study was to assess the effects of~     phototherapy applied at different times during 12 weeks of strength training. For such, 48~     volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength~     training protocol for the anterior muscle of the thigh development. Volunteers performed the~     training protocol twice a week for 12 weeks. There were assessed isometric peak torque in~     isokinetic dynamometer, 1-repetition maximum test in the leg extension and leg press~     machines and bilateral thigh perimetry.~   "
44517|NCT02474537|"~     This is a phase I, multi-center, open-label, single oral dose, parallel group study to~     evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired~     hepatic function and non-cancer subjects with normal hepatic function.The study population~     will be healthy male and postmenopausal or sterile female subjects who meet all of the~     inclusion and none of the exclusion criteria. Subjects will be assigned to groups according~     to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe~     (Group 4) impairment. This study consists of a two-staged design with interim analysis. In~     Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an~     interim analysis will be conducted. Depending on the results of the analysis, either the~     study will conclude with no further enrollment or Stage 2 will commence with enrollment of~     Group 4.~      A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study,~     participants will be confined to the facility for 4 days, given a single dose of INC280 and~     monitored for pharmacokinetic and safety assessments.~   "
44518|NCT02474524|"~     This project is a component of a broader research program referred to as Self-Management~     and Recovery Technology (SMART): Use of online technology to promote self-management and~     recovery in people with psychosis, which has been funded by the Victorian Department of~     Health Mental Illness Research Fund (MIRF33). The overall research program is examining the~     therapeutic potential of using online (Internet-based) educational and multimedia resources~     in mental health services. It involves the development of a website which can be accessed~     via an internet browser on a desktop computer, tablet computer, or smartphone. It consists~     of a series of educational modules containing textual information, exercises, audio, and~     video clips designed to promote self-management and recovery in people with a history of~     persisting mental illness.~      This particular project (SMART-Therapy) involves a randomised controlled trial examining the~     use of a discrete 8-session psychosocial intervention delivered in addition to routine care~     which utilises these online materials. The intervention will involve a mental health worker~     meeting with the participant with a tablet computer (e.g. iPad) on which online materials~     can be viewed, and used to guide an interaction with the participant.~      The randomised controlled trial will include 148 participants, who will be randomised to~     receive one of two interventions: (a) meeting with a support worker using the SMART website~     to guide interaction (health intervention), or (b) meeting with a support worker delivering~     a social interaction-based control condition (social intervention). In each condition, there~     will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed~     pre-randomisation, and at 3, 6 and 9 months.~      The primary hypothesis is that participants randomised to the health intervention will show~     greater improvement in personal recovery than participants randomised to the social~     intervention, and that these improvements will be maintained at follow-up (6 and 9 months~     following intake).~   "
44519|NCT02474511|"~     The purpose of this study was to investigate whether general anesthesia will affect the~     postoperative recurrence and metastasis of malignant tumor.~   "
44520|NCT02474498|"~     To clinically evaluate the treatment of mandibular class II furcation defects with enamel~     matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium~     phosphate/hydroxyapatite (βTCP/HA).~   "
44521|NCT02474485|"~     AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to~     evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting~     bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon~     Sequent Please®.~   "
44522|NCT02474472|"~     The primary objective of the study is to compare the efficacy of standard local anesthetic~     bupivicaine and liposomal bupivicaine in postoperative pain control both in magnitude and~     duration in patients undergoing sternotomy, thoracotomy, thoracoabdominal, and laparotomy~     incisions.~   "
44523|NCT02474459|"~     The purpose of this study is to test the use of a clinical decision support tool for~     postoperative care of Parkinson's disease patients who are treated using deep brain~     stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support~     system for individual patient management will enable considerable time savings and reduced~     burden on patients and caregivers.~   "
44524|NCT02474446|"~     The investigators want to make sure that people get the right dose of Vitamin D treatment.~     They will therefore investigate how skin colour, body mass index, ethnicity, vitamin D~     binding protein and genetic variation affect the response to a standard course of vitamin D~     in young adults, as a prelude to further studies in younger children.~   "
44525|NCT02474433|"~     This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several~     hours prior to hysteroscopy, comparing the different routes of administration~     (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of~     dilatation, time required to achieve dilatation and patient preference.~   "
44526|NCT02474420|"~     This is a randomized, open label, two arms superiority trial of a representative population~     of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of~     moderate cardiac iron overload, defined as an average T2* MRI parameter at the mid~     inter-ventricular septum between 10 and 20ms.~   "
44527|NCT02474407|"~     This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study~     involving adolescents and adults with refractory (drug-resistant) epilepsy~   "
44528|NCT02474394|"~     This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and~     Macintosh laryngoscope on intraocular pressure during laryngoscopy.~   "
44529|NCT02474381|"~     The vascular pathologic basis of diabetic foot include arterial obstruction and~     micro-circulation defects.The latest technology of arterial reconstruction can only rebuild~     blood flow of anterior,posterior tibial artery and peroneal artery.Endothelial progenitor~     cells have been proved to integrate into damaged vascular endothelium and improve~     vasculogenesis in vitro and in animal experiment.Therefore endothelial progenitor cells are~     supposed to improve the micro-circulation status of diabetic foot patients.In this trial,the~     investigators recuit diabetic foot patients with infrapopliteal arterial obstructive~     disease,treat them with autologous endothelial progenitor cells after intraluminal~     intervention,and observe the therapeutic efficacy comparing to single intraluminal~     intervention.~   "
44530|NCT02474368|"~     This research study seeks to gain new knowledge about the addition of a carefully targeted~     boost dose of radiation as a possible treatment for recurrent or metastatic head or neck~     cancer. The name of the study intervention involved in this study is stereotactic body~     radiotherapy, which is a way of delivering radiation in a more precisely targeted way and~     with a higher dose than conventional radiotherapy.~   "
44531|NCT02474355|"~     The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real~     world setting in adult patients with advanced or metastatic, epidermal growth factor~     receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have~     received prior EGFR-tyrosine kinase inhibitor (TKI) therapy.~   "
44532|NCT02474342|"~     The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue~     Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.~   "
44533|NCT02474329|"~     Background: Long-term management of Parkinson's disease (PD) does not reach its full~     potential due to lack of knowledge about disease progression. The Real-PD study aim to~     evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real~     life. Moreover, an explorative analysis concerning activity level, medication intake and~     mood will be done.~      Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this~     observational study. Dutch PD patients will be recruited across the country and an~     assessment will be performed using a short version of the Parkinson's Progression Markers~     Initiative (PPMI) protocol. Moreover, participants will wear a set of medical devices~     (Pebble Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App~     (Android app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical~     activity, falls and tremor, measured by the axial accelerometers embedded in the Pebble~     watch and fall detector; and 2) medication intake and mood reports measured by patients'~     self-report in the Android app. To measure motor impact, an assessment will be performed by~     physiotherapists who are all Unified Parkinson's disease rating scale - (MDS-UPDRS)~     certified.~      Discussion: Management of PD patients is complex and appears to be a challenging task for~     health care professionals. The main reason is the lack of knowledge in the disease pattern.~     This issue could be solved by a long term follow-up of patients' during their everyday life,~     and wearable medical devices can act as a way to collect data about every day life~     activities. Therefore, the Real-PD study will be a first contribution in increasing the lack~     of knowledge in disease progression, developing a new medical decision system and improving~     PD patients' care.~   "
44534|NCT02474316|"~     This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks~     NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb~     negative, will be randomized (1:1) into 2 study arms as follows:~      Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir~     0.5mg qd for 48 weeks~   "
44535|NCT02474303|"~     Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to~     rethink HIV prevention and treatment strategies, especially for key populations such as~     Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the~     potential to have a profound population-level impact on the course of the HIV/AIDS pandemic.~     Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis~     (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to~     translate these trial results into population-level effects is the next critical step. PrEP~     demonstration projects, in collaboration with local stakeholders and at sites of routine~     care for high-risk populations provide an opportunity to move promising research results~     into actual public health benefits. With these key features in mind, the investigators~     propose a HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The~     objective of the proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC)~     among Female Sex Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program~     for FSW in Dakar, Senegal while demonstrating the feasibility of providing daily oral PrEP~     with Truvada (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics~     (IHS, and Pikine, Mbao, Rufisque and Diamniadio Health Centers). Critical milestones for~     this demonstration project with be feasibility, uptake, acceptability, use of TDF/FTC PrEP~     and programmatic retention of FSWs in Dakar MoH clinics. The investigators have assembled an~     expert team from RARS,The University of Washington, and Westat that have had greater than 2~     decades of collaboration on HIV related projects in FSWs in Senegal. The investigators~     expect the results of this project will show that Senegal provides a unique opportunity to~     assess acceptability, feasibility, uptake and effectiveness of oral HIV PrEP at reducing HIV~     transmission in a high-risk FSW population.~   "
44536|NCT02474290|"~     The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of~     leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD~     positive acute myeloid leukemia (AML).~   "
44537|NCT02474277|"~     The aims are to identify predictive indicators of hospitalized elderly medical patients'~     need for rehabilitation and to validate (known group validity) the Chair Stand Test~   "
44538|NCT02474264|"~     This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to~     comparing the endothelial function of male BRCA mutation carriers with that of age matched~     non-BRCA mutation carriers.~   "
44539|NCT02474251|"~     The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta~     (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the~     mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ~     dynamics in the brain are influenced by the sleep-wake cycle, with increases in the~     production of soluble Aβ during wakefulness and decreases during non-rapid eye movement~     (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep [SWS]).~     These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has~     been documented in murine models and in humans. By better understanding this sleep-wake~     relationship the investigators hope to identify how sleep disorders accelerate the~     progression of AD in the elderly (which has been demonstrated by multiple epidemiological~     studies) and, in turn, identify novel therapeutic targets for AD prevention.~      The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain~     are influenced by the sleep-wake cycle in humans, and to test the directionality of this~     relationship through sleep disruption experiments. The investigators will test two models.~     The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be~     relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS~     that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing~     (SDB) or insomnia that are common in late life (Aim 1). The second model will test how~     stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of~     adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP)~     compliance will be used to test this model sleep deprivation experiments using therapeutic~     CPAP vs. sham CPAP.~      This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a~     group of cognitively normal elderly subjects as well as the effect of acute sleep disruption~     by CPAP withdrawal on CSF Aβ42 levels in a well characterized clinical sample of severe~     obstructive SDB patients on treatment with CPAP. The results from this study will improve~     our understanding of the nature of the Aβ diurnal pattern and the brain consequences of full~     night sleep disruptions as well as sleep disruptions during specific stages of sleep.~   "
44540|NCT02474238|"~     No single type of laser or set of laser parameters is appropriate for all type of irides.~     Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered~     as the gold standard for iridotomy. It, however, is less effective and causes some~     complication such as iris hemorrhage especially in patients with dark iris.~   "
44541|NCT02474225|"~     The introduction of additional fluid into the vitreous cavity by intravitreal therapy would~     be expected to cause an immediate rise in the intraocular pressure. This transient,~     short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal~     anti-vascular endothelial growth factor therapy has been well describe. The investigators~     aim to study the prevalence of the sustained intraocular pressure elevation associated with~     intravitreal injection of anti-vascular endothelial growth factor agents.~   "
44580|NCT02473497|"~     This is an open label expanded access protocol for the treatment of up to approximately 40~     adult or pediatric (defined as age <18 years) patients with tumors harboring either a~     chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an~     activating genetic alteration involving the cMET gene who cannot swallow the crizotinib~     capsule but may be able to derive benefit from treatment with an alternative oral~     formulation of crizotinib.~   "
44542|NCT02474212|"~     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in~     postoperative cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparin~     is administered either as a continuous intravenous infusion or subcutaneous bolus once~     daily.~      After informed consent, 80 elective on pump CABG patients with a clinical indication for~     post-operative thromboprophylaxis will be studied in the Tampere University Hospital Heart~     Central. The study will consist of two independent parts. In the first part of the study~     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin~     (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days. Another~     twenty patients will be randomised to receive the same dose of enoxaparin (40 mg) daily as~     continuous intravenous infusion for three days (72 hours). In the second part of the study~     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin~     (Klexane®, Sanofi-Aventis) 0,5 mg/ kg twice a day. Another twenty patients will be~     randomised to receive enoxaparin 1 mg/kg daily as continuous intravenous infusion for three~     days (72 hours).~   "
44543|NCT02474199|"~     This research study is for liver transplant recipients and their respective living donors.~      The purpose of this study is:~        1. To see if it is safe for liver recipients to receive one dose of donor reactive T~          regulatory cells (Tregs)~        2. To see if the Tregs allows a liver recipient to take less, or completely stop~          medications normally taken after receiving an organ transplant.~   "
44544|NCT02474186|"~     1. To induce immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemo-radiation of a metastatic site in metastatic breast cancer~          patients.~        2. To monitor the induction of a T cell response.~        3. To explore the role of PET scanning to assess tumor responses/abscopal effect.~   "
44545|NCT02474173|"~     This phase Ib trial studies the side effects and best dose onalespib when given together~     with paclitaxel in treating patients with triple negative breast cancer that has spread to~     other places in the body and usually cannot be cured or controlled with treatment~     (advanced). Onalespib works by blocking proper processing of proteins that are important for~     cancer growth. This results in inability of these proteins to work properly. Paclitaxel~     kills breast cancer cells by interfering with their ability to divide. Giving onalespib~     together with paclitaxel may be better in treating patients with breast cancer.~   "
44546|NCT02474160|"~     This research trial collects and stores tissue and blood samples from patients with cancer.~     Collecting and storing samples of tissue and blood from patients with cancer to study in the~     laboratory may help scientists create new and better models to learn about cancer and to~     test new cancer drugs.~   "
44547|NCT02474147|"~     The purpose of this study is to~        1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian~          sandwich) in response to the postprandial period by using functional brain imaging of~          reward circuitry implicated in food motivation and energy balance in patients with type~          2 diabetes (T2D), obese subjects and healthy controls.~        2. Characterize some of the pathophysiological mechanisms of action of different meals in~          obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA,~          IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)~   "
44548|NCT02474134|"~     The purpose of this study is to compare the safety, tolerability, and blood levels of two~     interferon beta-1b products, Betaferon and PF530, in healthy volunteers.~   "
44549|NCT02474121|"~     This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat~     subjects with critical limb ischemia (CLI) caused by severe PAD.~   "
44550|NCT02474108|"~     This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation~     in patients with valvular heart disease and left atrium enlargement~   "
44551|NCT02474095|"~     This randomized pilot clinical trial studies alternate schedules for acupuncture-like~     transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia)~     caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a~     procedure in which mild electric currents are applied to certain acupuncture points on the~     body and may help relieve dry mouth caused by RT and improve quality of life. It is not yet~     known whether giving ALTENS more frequently works better than standard ALTENS in treating~     dry mouth caused by RT.~   "
44552|NCT02474082|"~     This is a randomized, controlled, multicenter, open-label study with blinded assessment of~     the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate~     to severe plaque type psoriasis who are candidates for systemic therapy. The study consists~     of 2 periods: a screening period of at least one week and up to four weeks, and a treatment~     period of 24 weeks. During the screening period eligibility of the patients is confirmed.~     Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in~     treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20~     and are followed up for assessments of the study endpoints until week 24. Patients in~     treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of~     secukinumab and Fumaderm® will be performed throughout the study and up to week 24.~   "
44553|NCT02474069|"~     This study is designed to support the optimal use of secukinumab by providing data to refine~     guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to~     explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients~     who had less than almost clear skin at week 16.~   "
44554|NCT02474056|"~     We hypothesis that in various situation when the effective blood volume decreased the venous~     volume flow characteristics change according to the fluid resuscitation~   "
44555|NCT02474043|"~     The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral~     intervention for promoting screening for hepatitis C and reducing risky behavior for people~     who inject drugs (PWID).~   "
44556|NCT02474030|"~     This study was conducted with an aim to know how individual attributes associated to~     intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold~     associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and~     psychological state evaluated by the Profile of Mood States.~   "
44557|NCT02474017|"~     To confirm the robustness of the CRC749 inhaler.~   "
44581|NCT02473484|"~     The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass~     spectrometry imaging (MALDI MSI). In order to provide more specific informations for the~     diagnosis and the prognosis of high grade glioma.~   "
44558|NCT02474004|"~     In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the~     knee adduction moment (KAM) during walking. Other researches found out that an increase of~     the KAM is an important factor contributing to degeneration joint disease of the knee~     (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons,~     because preserving as much of the meniscus as possible is assumed to delay degenerative~     joint disease.~      The investigators hypothesize significant differences in knee adduction moments between~     patients treated with partial medial meniscectomy vs. patients treated with medial meniscus~     repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the~     mentioned groups differ with respect to other kinetic and kinematic key parameters of gait~     (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as~     determined by a typical knee score (hypothesis 3).~   "
44559|NCT02473991|"~     The aim of this prospective longitudinal study was to investigate the relationship between~     placental thickness during the second and third trimesters and placental and birth weights.~   "
44560|NCT02473978|"~     In this study the investigator would like to examine hemodynamic cerebral blood flow and~     brain function by the use of Invos cerebral oximetry in women undergoing cesarean section~     delivery.~      This study is a purely observational study, it will not have any clinical intervention nor~     will it interfere with standard cesarean delivery protocols in any way.~      The investigator's primary objective is to evaluate how anesthesia influences cerebral blood~     flow perfusion during cesarean section deliveries.~   "
44561|NCT02473965|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the~     efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified~     (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia~     Gravis (MG).~   "
44562|NCT02473952|"~     The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to~     placebo in subjects with MG.~   "
44563|NCT02473939|"~     The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated~     doses in mild asthmatics (part 2).~   "
44564|NCT02473926|"~     This study plans to learn more about physical activity and physical function in sedentary~     older adults with type 2 diabetes.~   "
44565|NCT02473913|"~     The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk~     thistle) in children and adults with trichotillomania. The hypothesis to be tested is that~     silymarin will be more effective and well tolerated in children and adults with~     trichotillomania compared to placebo. The proposed study will provide needed data on the~     treatment of a disabling disorder that currently lacks a clearly effective treatment.~   "
44566|NCT02473900|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1403 and HGP0919 in healthy male volunteers~   "
44567|NCT02473887|"~     The purpose of this study is to give children with gastroenteritis with persistent vomiting~     flavored intravenous ondansetron orally. The investigators test the palatability of the drug~     and check the serum level of ondansetron at 4 hours .~   "
44568|NCT02473874|"~     The purpose of this study is to obtain skin spectroscopic data from two imaging systems.~      Comparison groups:~        -  Skin Spect dermoscope~        -  Spatially modulated quantitative spectrometer~   "
44569|NCT02473861|"~     This study is a randomized control cross over trial of exercise training during or after~     taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage~     I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise~     training for 8-12 weeks. The immediate exercise group will exercise during taxane~     chemotherapy and the delayed group will start exercise 2 weeks after completion of~     treatment. This design will allow for an assessment of the effects of exercise vs usual care~     during treatment, plus a comparison of the training response during vs. after chemotherapy.~   "
44570|NCT02473848|"~     The substance ingenol mebutate (IM) is registered in Switzerland and many countries~     worldwide for the treatment of actinic keratosis (AK). There is no data on the use of IM in~     organ transplant recipients, a population highly affected by AK and skin cancer at large.~     The investigators want to study the use of IM against AK in this high-risk group of patients~     and assess its safety. The investigators are hoping to prove that IM is safe to use in AK of~     organ transplant recipients, allowing its use in the clinical routine treatement of AK also~     in this subset of patients with AK.~   "
44571|NCT02473835|"~     Overweight and obesity are major problems and their complications such as cardiovascular~     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is~     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in~     part by the expansion of adipose (fat) tissue.~      In addition to adipocytes (fat cells), adipose tissue contains a whole range of other cell~     types including some immune (white blood) cells. The relative proportions of immune cell~     subpopulations and interactions between the different cell types within adipose tissue may~     be important in the development of type 2 diabetes.~      Previous research by the investigators has suggested that there may be important differences~     in the activation status of certain immune cells located in adipose tissue with increased~     overweight and the production of leptin - an appetite regulating hormone. Properties of~     adipose tissue and inflammatory cells located within it may therefore be sensitive to~     changes in our nutritional status.~      The purpose of the present study is to investigate changes in T cell activation in adipose~     tissue alongside other immunometabolic properties before and after a short period of dieting~     compared to changes in blood.~      Participants will include males aged between 35-55 years old who meet the criteria for~     inclusion. After taking some preliminary measurements and monitoring of normal daily~     activities, participants will reduce their calorie intake to 50 % of their normal~     intake/requirements for 3 consecutive days and will attend 1 session of Laboratory testing~     before and 1 after this period which will take place in the Physiology Laboratories at the~     University of Bath.~      It is hoped that investigating immunometabolic responses within adipose tissue following an~     acute nutritional challenge will help lead to a better understanding of the development of~     diseases associated with being overweight and ultimately help in the development of more~     effective methods for prevention and treatment.~   "
44572|NCT02473822|"~     This is a non-interventional study to retrospectively validate the technical use TLS (Tape~     Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the~     validity of the technique and its positive influence on the resumption of sporting~     activities in relation to the existing literature.~   "
44573|NCT02473809|"~     The purpose of this study is to test whether liraglutide, a drug approved and widely used in~     the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2~     diabetes may cause multiple complications, and it is well known that patients with type 2~     diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a~     positive effect on bone, this may be one among other factors to consider before the decision~     about specific treatment of type 2 diabetes is made for the individual patient.~   "
44574|NCT02473796|"~     Melghat is poorly developed tribal area in India with very high child mortality &~     malnutrition prevalence (grossly inadequate medical facilities). Important health problems.~     Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W.~     babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home~     Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate~     (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region.~      Melghat.~      Need of project :~      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the~     research:. The results obtained in this area will be applicable for reducing children~     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.~      Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI,~     Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing~     government ICDS and health system.~      Melghat.~      Need of project :~      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the~     research:. The results obtained in this area will be applicable for reducing children~     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.~      Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria~     clinically & Neonatal care) in 19 villages.~   "
44575|NCT02473783|"~     Objectives:~        1. To evaluate the relationship between improvement of Hamilton Depression Rating Scale~          (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD~          subjects being treated with Sertraline HCl~        2. To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for~          assisting in detecting MDD~        3. To evaluate the relationship between basal HAMD score and basal SERT availability for~          MDD subjects~        4. To evaluate the relationship between basal HAMD somatic subscale score and basal SERT~          availability for MDD subjects~        5. To evaluate the relationship between change of SERT availability and change of HAMD~          score for MDD patients being treated with Sertraline HCl~   "
44576|NCT02473770|"~     Background:~      - Disasters like earthquakes, floods, and oil spills can give people health problems.~     Workers who respond to a disaster (like police and firefighters) are directly exposed to~     contaminants during the emergency response. So they could be at the greatest risk for these~     problems. Researchers want to gather data about these workers before and right after they go~     to a disaster. They hope this will help them understand the health effects of disasters.~      Objectives:~      - To answer questions about the health effects of disaster exposures. To create a~     participant registry and collect biological samples and health data.~      Eligibility:~      - People at least 21 years of age who are sent to a disaster area for an emergency response.~      Design:~        -  Participants will have 1 study visit.~        -  Participants will answer questions about:~        -  Contact information~        -  Health, lifestyle, emotions~        -  Medical history~        -  Disaster response activities~        -  Things they are exposed to in the environment~        -  Participants may have blood collected from a vein in the arm.~        -  Participants may give biological samples. These may be urine, saliva, cheek cells, nail~          clippings, or hair.~        -  Participants will have a short physical exam. They may have their hip and waist~          measured over their clothes. The amount of oxygen in their blood may be measured by a~          sensor on a finger or ear.~        -  Participants may have a lung function test. They will take a deep breath and exhale~          strongly.~        -  Participants will be asked to agree to be contacted later to update contact data and~          learn about future studies.~   "
44577|NCT02473757|"~     Background:~      - Gene therapy is a way to treat or prevent disease using genes. It is monitored very~     closely by regulators because there can be long-term, unexpected side effects. NIH is~     required to try to contact people who have been treated with gene therapy at least annually~     for up to 15 years. This is to see if they have had any bad side effects. This trial does~     not include any therapy and is only for patients previously treated on gene-therapy trials~     at the NCI Experimental Transplantation an Immunology Branch who are no longer enrolled on~     their original gene therapy clinical trial.~      Objective:~      - To collect of long-term follow-up data on people who have been in gene transfer studies.~     This follow-up is required by regulators.~      Eligibility:~      - People age 18 and older who have been in a previous NCI Experimental Transplantation and~     Immunology Branch gene therapy research study.~      Design:~        -  After they get the genetically modified cells, participants will:~        -  Have blood drawn 3, 6, and 12 months later.~        -  Have an annual clinic visit for the next 4 years. They will have a physical exam. They~          will answer questions about any signs of neurological, autoimmune, or blood disorders,~          or any new cancers. Blood <TAB>may be drawn.~        -  Be called or emailed annually for the next 10 years. They will answer health questions.~          Blood samples may need to be taken.~        -  Participants will be asked for their current address and phone number. They will also~          be asked for the address and phone number of 1 or 2 people who will know their~          whereabouts. One of these should be a family member if possible,~        -  At the time of the participant s death, researchers will request permission from their~          family for an autopsy.~   "
44578|NCT02473744|"~     -  Background : Edema of lower extremities is a concern ranging from 19 % to 60% of~          palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily~          activities, esthetic and behavior. Usual treatment is based on diuretics and~          physiotherapy but is often unsuccessful. In case of conventional treatment failure, in~          palliative care, subcutaneous drainage can be discussed with the patients. The~          technique is simple, easy to use but remains off the record. Since 2004, 23 cases were~          reported with various methods. All the cases reported were undertaken with various~          technical approaches and efficacy criteria.~        -  Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is~          effective in case of refractory lymphedema of the lower limbs in palliative care and~          leads to an improvement in QOL in terms of behavioral and autonomy.~   "
44579|NCT02473731|"~     The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck~     cancer patients and to explore downstream molecular pathways to identify tumor response and~     resistance mechanisms by evaluating various biomarkers before and after treatment.~   "
44582|NCT02473471|"~     The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the~     miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and~     pain's interference, the level of satisfaction and comfort using this protocol. Finally root~     resorption associate with this technique will be evaluated.~   "
44583|NCT02473458|"~     Stroke is one of the most important causes of mortality and disability both in developed and~     developing countries. The only food and drug administration (FDA) approved therapy for acute~     stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has~     limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective~     drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be~     mandatory in the world of cerebrovascular medicine.~      Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used~     in food industries. Certain medical properties has been contributed to licorice and~     specifically to its active chemical components such as flavonoids and glycyrrhizic acid~     (GA). GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a~     key component of lipopolysaccharide-induced inflammatory response. Neuroprotective~     characteristics of GA has been widely investigated in recent studies.~      In the present study, the investigators verified the efficacy and safety of oral~     administration of two different doses licorice extract in the patients with acute ischemic~     stroke, in a double-blind randomized controlled trial.~   "
44584|NCT02473445|"~     Patients (male or female) with either documented genetically confirmed diagnosis of~     inherited mitochondrial diseases, who are ≥ 2 years old and < 18 years, and meet other~     specified inclusion and exclusion criteria, will be included in this study.~      Patients with inherited mitochondrial diseases associated with nuclear or mitochondrial DNA~     mutations that impair the respiratory chain. These include, but are not limited to the~     following clinical syndromes: Leber's hereditary optic neuropathy; myoclonic epilepsy and~     ragged-red fibers (MERFF); mitochondrial encephalomyopathy, lactic acidosis, and stroke-like~     syndrome (MELAS); Kearn-Sayre syndrome; subacute necrotizing encephalopathy (Leigh~     Syndrome); POLG-related disorders (Alpers-Huttenlocher Syndrome, Autosomal Dominant~     Progressive External Ophthalmoplegia, Autosomal Recessive Progressive External~     Ophthalmoplegia, Childhood Myocerebrohepatopathy Spectrum Disorders, Myoclonic Epilepsy~     Myopathy Sensory Ataxia, POLG-Related Ataxia Neuropathy Spectrum Disorders); Mitochondrial~     neurogastrointestinal encephalopathy syndrome (MNGIE), also called myoneurogastrointestinal~     encephalopathy syndrome or POLIP syndrome; others, e.g., mitochondrial cardiomyopathies and~     other syndromes due to multiple mitochondrial DNA deletions.~      Patients completing the RP103-MITO-001 study are eligible for enrollment into the extension~     study if all inclusion and exclusion criteria are fulfilled. Subjects continue on the last~     total daily dose of RP103 taken during RP103-MITO-001. Dose-adjustments are permitted.The~     sample size is maximally 25 subjects.~   "
44585|NCT02473432|"~     This study, part of a larger research project (The Retornus Study), is aimed to evaluate new~     strategies to optimize rehabilitation outcomes in dysphagic stroke patients. Main objective~     is to assess effectiveness of neuromuscular electroestimulation (NMES) in combination with~     respiratory muscle training (RMT) in the treatment of oropharyngeal dysphagia in subacute~     stroke patients.~   "
44586|NCT02473419|"~     The objective of this research is to use functional magnetic resonance imaging (fMRI) with a~     neuropsychological task to test the prefrontal mechanism of action of the medical food~     Vayarin.~   "
44587|NCT02473406|"~     Infected pancreatic necrosis and its related septic complications are the major cause of~     death in patients with acute pancreatitis, therefore prevention of pancreatic infection is~     of great clinical value in the treatment of AP.~      Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced~     CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of~     pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties~     and its effects in preventing pancreatic infection was not well studied. To evaluate the~     effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation~     and clinical outcomes in patients with AP,we aimed to design this study.~   "
44588|NCT02473393|"~     To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial~     Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.~   "
44589|NCT02473380|"~     Intraoperative surgical fluorescence microscopy is a useful technique for the surgical~     resection of glioma. However the accuracy of this method is limited by its too low~     sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current~     limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a~     pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure~     two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which~     clearly enables to distinguish the solid component of glioblastomas from low grade gliomas~     and infiltrative component of glioblastomas. This innovative method could become in future a~     useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post~     resection to check for residual dysplasia) and real-time assessment of resections margins~     during surgery. However, those preliminary ex-vivo results have to be confirmed in a~     feasibility in-vivo study on human.~   "
44590|NCT02473367|"~     In order to define the safe windows for co-dosing of metal-cation antacids with once daily~     administered raltegravir, this study will evaluate the effect of both calcium carbonate and~     magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage~     of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice~     daily as part of their HIV treatment regimen.~   "
44591|NCT02473354|"~     Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms~     of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic~     conditions. (2) Measurement of specific respiratory parameters to predict the opioid-induced~     respiratory depression (OIRD) response.~   "
44642|NCT02472691|"~     This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate~     the safety and feasibility of the addition of Lenalidomide (investigational drug) to the~     standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for~     relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow~     blasts, formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day~     for 21 days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and~     20 patients in order to find the optimal and safe dose of Lenalidomide.~   "
44709|NCT02471820|"~     This study is to assess the efficacy and safety of lenalidomide in combination with~     adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple~     myeloma as well as to collect information regarding the effect of this regimen on~     angiogenesis and bone remodeling of the study population.~   "
44592|NCT02473341|"~     Severe Alcoholic hepatitis, defined by modified Maddrey's Discriminant Function (DF) ≥32, is~     associated with significant morbidity and mortality. (1,2) Of the various treatment~     modalities evaluated for treatment of Severe Alcoholic hepatitis (SAH), Corticosteroids have~     been the most extensively studied.(1) Five out of 13 Randomized controlled trials, and four~     out of 5 meta-analysis have shown a survival benefit with Corticosteroids, especially in~     patients with DF ≥32 and/ or Hepatic Encephalopathy.(1-4) However, the role of~     Corticosteroids in Severe Alcoholic hepatitis still remains somewhat controversial.(5-6)~     Corticosteroids therapy is not considered the ideal option by all authors because their~     beneficial effect seems to be confined to a highly selected minority group in which the~     inhibitory effect of corticosteroids on liver inflammation is not outweighed by side effects~     such as weakened defense against infections, anti-anabolic effects, and possible ulcer~     promoting effects.(6) Corticosteroids are supposedly contraindicated in DF > 54 or MELD~     >24.(7) This need to be confirmed. Also Corticosteroids are contraindicated in patients with~     renal failure, gastro-intestinal bleed, pancreatitis and active sepsis. Therefore, there~     have been constant efforts to evaluate new therapies for SAH. In a recent trial, combination~     of glucocorticoids plus N-acetylcysteine was found to improve one month survival in patients~     with Severe Alcoholic hepatitis, compared with glucocorticoids alone. However the six month~     survival was not different in both groups. (8) Bovine Colostrum is rich in protein,~     immunoglobulin, lactoferrin and growth factors. Recent studies suggest that Colostrum~     components, immunoglobulin and growth factor benefits physically active person and in~     treatment of autoimmune disorders. It is used for the treatment of a wide variety of~     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut~     injury, H pylori infection, immune deficiency related diarrhea as well as infective~     diarrhea. (9) The guidelines by American College of Gastroenterology (10) and other authors~     (11) have suggested that a combination of Corticosteroids and other drugs, which have~     different mechanisms of action, may be more beneficial for reducing mortality in severe~     alcoholic hepatitis. Hence, the investigators plan to compare the efficacy of combined~     therapy of Corticosteroids and Bovine colostrum versus Corticosteroids alone in treatment of~     severe alcoholic hepatitis.~   "
44593|NCT02473328|"~     The goal of antiretroviral therapy should be maintaining undetectable plasma viral load,~     only present condition to prevent the progression of the disease, improve immune restoration~     and prevent the emergence of viral resistance mutations. In addition to the individual~     benefit, antiretroviral treatment reduces the transmission of HIV from an infected person to~     sexual partners. There is to date no alternative strategy to antiretroviral treatment and~     antiretroviral therapy, even extended, does not allow viral eradication.~      The need to maintain antiretroviral therapy for life raises the long-term safety concerns of~     it, even with the latest molecules. Also, one of the key issues in clinical research is~     whether after reaching undetectable viral load, antiretroviral treatment can be reduced in~     order to reduce exposure to molecules. Indeed, this treatment of maintenance could~     potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral~     treatment reduces costs, an important consideration in light of new global recommendations~     of treatment for all patients with T-cells CD4 below 500 / mm3.~      The alleviation of antiretroviral therapy is to either reduce the number of molecules by~     making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce~     the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of~     Efavirenz 400mg instead of 600mg in naive patients.~      Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with~     two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable~     viral load.~   "
44594|NCT02473315|"~     Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition~     at a temperature of approximately -110 degrees.~      A considerable increase in the popularity of WBC has occurred in rheumatologic patients,~     despite a lack of evidences of its efficiency.~      Because of its interesting anti-inflammatory properties, the investigators think that WBC~     could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory~     Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis.~      This is a proof of concept study.~   "
44595|NCT02473302|"~     Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in~     Western country.~      The main risk factors associated with colorectal cancer depend of lifestyle, and processed~     meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound~     linked to lipid peroxidation and nitrosation.~      The aim of this study is to study the impact of the daily consumption of beef, processed or~     not, on lipid peroxidation induced heme iron ; and to study the impact of the daily~     consumption of ham, processed or not, on the nitrosilation induced heme iron.~   "
44596|NCT02473289|"~     The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment~     to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a~     50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12-~     week double-blind treatment period) is compared to adjunctive placebo based on the change~     from baseline to 12-week endpoint in depressive symptoms as measured by the total score on~     the Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive~     Disorder (MDD) who have had a suboptimal response to the current standard oral~     antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP)~     >=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A~     cohort of subjects with hsCRP <0.300 milligram per deciliter will also be enrolled to allow~     a better understanding of the relationship between CRP and clinical changes.~   "
44597|NCT02473276|"~     Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the~     most effective modality available for pain relief during labor. Accidental dural puncture~     (ADP) with a large bore epidural needle and the resulting post-dural puncture headache~     (PDPH) is one of the most significant sources of anesthesia-related morbidity in~     parturients.~      Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost~     always effective, can result in another ADP, as well as low back pain and lower extremity~     pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly~     valuable. One small study in which 50 women were randomly allocated to receive 2 epidural~     injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in~     decreasing the incidence of PDPH.~      This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or~     intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.~   "
44598|NCT02473263|"~     The purpose of this study is to determine whether an aggressive strategy of severe sepsis~     patients since pre hospital care, including early antibiotics administration, hemodynamic~     optimization, and opotherapy when indicated, could reduce mortality~   "
44710|NCT02471807|"~     The study is a multi-center, prospective, early feasibility study to measure individual~     patient clinical outcomes and effectiveness, evaluate the safety and function, provide~     guidance for future clinical study designs and development efforts of the Edwards FORMA~     Tricuspid Transcatheter Repair System.~   "
44599|NCT02473250|"~     Bipolar disorder is associated with alterations of chemicals in the brain, including one~     named serotonin. Treatment of depression in bipolar disorder can be accomplished by~     increasing serotonin function by a medication named fluoxetine (Prozac). Serotonin signals~     in the brain occur through receptors in a way that is similar to a lock and key, where~     serotonin is a key and the receptor is a lock. One important receptor is the serotonin 1A~     (5-HT1A) receptor. This receptor has been found to be abnormal in bipolar disorder during~     periods of depression, as measured by a type of brain imaging called positron emission~     tomography (PET). The amount of brain 5-HT1A receptor measured by imaging has also been~     associated with how well depressed patients with major depressive disorder respond to a~     medication that is similar to fluoxetine (Prozac). This project will measure the 5-HT1A~     receptors in bipolar depressed individuals using PET with the radiotracer [11C]-CUMI-101 and~     will evaluate the ability of this brain imaging signal to predict how patients respond to~     fluoxetine (Prozac) treatment when added to a mood stabilizer (valproate).~   "
44600|NCT02473237|"~     Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a~     chronic respiratory condition frequently excluded from large clinical trials. Biomass~     exposure COPD have some histopathologic, clinical, radiological and functional differences~     with tobacco smoke COPD. However, until now, there are no evidence in this patients about~     the clinical response to bronchodilators routinely used in tobacco smoke COPD.~      Primary objective: To compare changes in walked meters from baseline on six minute walking~     test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with~     moderate to severe COPD secondary to biomass exposure.~      Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced~     Expiratory Volume in first second (FEV1) milliliters, FEV1 through) from baseline (-10~     minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with~     moderate to severe COPD secondary to biomass exposure.~      This will be an open label study, double blinded, cross over and conducted at specialized~     respiratory care center (National Institute of Respiratory Diseases), to compare the acute~     effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric~     study.~      Ethics Committee approbation: C 22-12~   "
44601|NCT02473224|"~     This is a phase I, randomized, double blind, placebo-controlled safety, illness, and~     infection study of a new experimental human challenge stock of the Norovirus genogroup II,~     genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The primary objectives are~     to evaluate the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge~     stock and to determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to~     achieve illness in a high proportion of subjects.~   "
44602|NCT02473211|"~     For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there~     is a burning need for the development of pan-oral interferon-free regimen. The investigators~     examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and~     daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced~     cirrhosis patients with chronic G1b infection.~   "
44603|NCT02473198|"~     The main objective of the study is to determine if intrarticular injection with liposomal~     bupivicaine (Exparel) provides better postoperative pain relief and functional outcome~     following total knee replacement (TKR) than the current standard New England Baptist~     Hospital regimen of femoral nerve block combined with intraarticular injection of a standard~     bupivicaine solution.~   "
44604|NCT02473185|"~     Aim: The purpose of the study is to examine the effects of medication, placebo and~     expectation on objective and self-rated performance of ADHD core signs during the Quantified~     Behavior Test in patients with untreated ADHD.~      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric~     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.~      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The~     study is taken place during four hours on two investigating days, separated by a 4 days~     wash-out period.~      All patients participate on two occasions: In one session they receive the Methylphenidate~     (MPH) condition, and in the other session they receive the placebo condition. MPH and~     placebo conditions are counterbalanced across subjects such that half of the participants~     receive MPH first, and the other half of the participants receive placebo first. Neither the~     participant nor the research assistant is aware when the participant receive the MPH~     condition or the placebo condition.~      On each investigating day the participant accomplish Questionnaires (Visual Analogical~     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise,~     (d) perceived help from the pill and (e) self-rated symptoms. In addition the participant~     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test~     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective~     information regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity~     measured with the camera, and inattention and impulsivity on basis of the CPT-test.~      The Quantized Behavior Test (QbTest) can be included as part of an neuropsychiatric~     investigation. QbTest measures the three core signs of ADHD, hyperactivity, inattention and~     impulsivity. QbTest is a computer-based test that combines a test of attention ability with~     a movement analysis based on an infrared measurement system. The test results are presented~     in a report and compared with norm data fromm a group of the same sex amd age who do not~     have ADHD.~   "
44605|NCT02473172|"~     This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm~     efficiency in mechanically ventilated critically ill patients. Participants will be~     randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure~     support ventilation (PSV) mode.~   "
44606|NCT02473159|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to~          ensure better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
44643|NCT02472678|"~     Patients with a neuroendocrine tumor (NET) frequently suffer from physical as well as~     psychosocial complaints. Patients may experience various symptoms from tumor burden and~     secreted hormones by the tumor. They also can have complaints due to their anti-cancer~     treatment and accompanying side effects.~      Adequate information is an essential aspect of supportive care. Patients need for~     information and care remain frequently unnoticed. The aim of the current study is to test~     the effectiveness of a web-based tailored information and support system to support~     patients' information and care needs. Key features of this website are patient~     self-screening of physical and psychosocial problems, tailored patient education on reported~     problems and self-referral to professional health care. The investigators expect that the~     website is a highly suitable medium to provide tailored information and support.~   "
44644|NCT02472665|"~     Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with~     severe Von Willebrand Disease (VWD).~   "
44607|NCT02473146|"~     Purpose : The main objective of this study is to assess the efficacy and tolerance of the~     addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition~     with standard doses of Ara-C in previously untreated patients aged 65 to 80 years with de~     novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for~     efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates,~     cumulative incidence of relapse and overall survival. The secondary endpoints for safety are~     early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse~     events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment~     by covariate interactions with respect to biological characteristics present at diagnosis~     (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual~     disease levels). This study is an exploratory study. Patients will be allocated at inclusion~     with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and~     cytarabine in a 3+7 regimen similar to the backbone ALFA 1200 scheme used concurrently by~     the ALFA group as treatment of AML patients aged >60 years.~      Primary objective. The primary objective is to assess the efficacy of two doses of~     Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in~     combination with Cytarabine in elderly patients with AML in the non adverse~     cytogenetics-risk group.~   "
44608|NCT02473133|"~     In patients with locally advanced stage III non-small cell lung cancer, the probability of~     local control remains low (about 17% at 1 year). Concomitant radio-chemotherapy is the~     standard treatment. An increase in total radiotherapy dose (from 66 to 74 Gray) has been~     proposed to improve local control, with contradictory results.~      Relevant FDG-PET scan images can be acquired during radio-chemotherapy, with a demonstrated~     prognostic impact and recently in a multicentre prospective study. A significant reduction~     in FDG uptake / volume (metabolic response) suggests that the radiotherapy target volume~     could be reduced during radiotherapy possibly improving organs at risk tolerance.~     Conversely, a lack of metabolic response may justify treatment intensification before the~     end of radiotherapy. The investigators hypothesis is to investigate the individual tumour~     heterogeneity on FDG-PET during radio-chemotherapy to reduce the volume to a biological~     target that could receive a higher total dose (personalized dose redistribution).~   "
44609|NCT02473120|"~     The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in~     patient with metastatic breast cancer.~   "
44610|NCT02473107|"~     The present study aims to evaluate the impact of detecting active initial caries lesions in~     primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and~     satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary~     dentition will be examined and treated in a mobile dental unit, which will temporarily be~     parked in public schools of Sao Paulo. The caries detection will be conducted using the~     International Caries Detection and Assessment System (ICDAS) and, depending on allocation,~     an adjunct criterion for caries activity assessment. Children will be randomized in two~     groups according to the caries threshold to be detected: Group A (only advanced lesions will~     be detected and treated, independently of their activity status) and Group B (all caries~     lesions, including initial ones, will be detected and all active lesions will be treated).~     After this, the treatment plan for each child will be made according to strategies mentioned~     above. Data concerning the cost-effectiveness of the procedures, acceptability /~     satisfaction of children and quality of life will be collected after diagnosis, after the~     end of treatment and 12 and 24 months from the initial examination. For comparison between~     groups, multilevel regression analyses will be performed. The primary outcome will be sites~     which need of operative treatment during the follow-up periods and the secondary outcomes~     will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the~     child and the impact on quality of life.~   "
44611|NCT02473094|"~     A phase II, randomized study of placebo versus metformin in association to chemotherapy with~     capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or~     TxN1-2M0) rectal carcinomas.~   "
44612|NCT02473081|"~     The purpose of this study is to determine whether the telephone-delivered Minimal~     Psychological Intervention (MPI) could improve diabetes' depressive symptom and~     diabetes-related immediately , as well as HbA1c level in the long-term.~   "
44613|NCT02473068|"~     Patients who are suffering from a variety of respiratory conditions benefit from continuous~     positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some~     patients find the temperature of the breathing gas difficult to tolerate. The aim of this~     study is to compare comfort of healthy volunteer participants while being given CPAP at~     different temperatures.~   "
44614|NCT02473055|"~     90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest)~     group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3~     hours, then fed, then KC group was placed in KC and control group remained in incubator for~     a 2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .~   "
44615|NCT02473042|"~     The goal of this clinical research study is to learn if light electrical stimulation to the~     wrist area during surgery is feasible in women having breast surgery.~   "
44616|NCT02473029|"~     The study aims at measuring the sensitivity and specificity of a series of imaging signs~     (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular~     ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis~     of Horton disease, the gold standard being the result of temporal artery biopsy.~   "
44617|NCT02473016|"~     A placebo-controlled, single-blind study to evaluate the safety and preliminary efficacy of~     nasal carbon dioxide for the symptomatic treatment of classical trigeminal neuralgia.~   "
44645|NCT02472652|"~     Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men~     and women. Antipsychotic induced sexual side effects may be a barrier to treatment~     compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have~     higher rates of causing prolactin elevations that may be implicated in sexual dysfunction.~     The basic premise of this study is to identify patients who believe they have experienced~     sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long~     acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels.~     Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience~     Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine~     if such a switch is helpful.~   "
44618|NCT02473003|"~     Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality~     of life negatively. There is limited knowledge about the physical mechanisms that cause~     fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience,~     but the investigators need to learn more about the type and intensity of exercise that works~     the best as well as how to motivate patients to exercise. The overall aim, is to evaluate~     the efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM)~     intensity physical training, with or without behavioural medicine (BM) support strategies,~     during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life~     (QoL), mood disturbance, adherence to the cancer treatment, adverse effects, disease~     outcome, return to a daily life after completed treatment and return to work. The~     investigators will also describe changes in inflammatory markers and cytokines related to~     physical training and gene expressions following training to investigate whether these serve~     as mediators for the effects of physical training on CRF and QoL. This will be evaluated in~     newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at~     three different centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design~     will be used, 600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train~     two times per week during 6 months. This project will give; new knowledge about aspects for~     individuals to gain improved well-being and quality of life, facilitated return to work, and~     possibly reduced risk of cancer recurrence. This in turn would result in lower burden on the~     health care system, reduced societal costs and have a positive impact on public health.~     Implementation of the results into clinical practice will be facilitated by the close~     collaboration between researchers and clinicians, and the fact that the study is performed~     in clinical settings.~   "
44619|NCT02472990|"~     The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a~     pejorative event. Biomechanical and morphological unknowledge about the loss of the walk~     ability in children with DMD is an obstacle in reeducative, pharmacological or surgical~     therapeutic targets.~   "
44620|NCT02472977|"~     The purpose of this study is to determine whether the combination of Ulocuplumab and~     Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung~     cancer.~   "
44621|NCT02472964|"~     A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and~     safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane~     as first line therapy in patients with HER2-positive metastatic breast cancer.~   "
44622|NCT02472951|"~     Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The~     investigators hypothesize that a lower carbohydrate content in the diabetic diet than the~     recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic~     factors like incretin hormones and decrease their insulinotropic effects due to their~     glucose dependency. This will reduce postprandial insulin concentration, resulting in an~     improved insulin sensitivity and glucose metabolism. This clinical study will examine in~     diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled~     dietary low carbohydrate intervention on metabolic pathways with respect to insulin action,~     pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in~     plasma and novel measures of fatty acid metabolism.~   "
44623|NCT02472938|"~     The primary objective of the study is to assess the early efficacy of treatment with BG00012~     (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and~     naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The~     Secondary objectives are to establish the time course of the beneficial effect of BG00012~     240 mg BID over 24 weeks and to evaluate the safety of BG00012.~   "
44624|NCT02472925|"~     This is a 3-arm, multi-center, patient-randomized, field evaluation of the Way to Cure~     behavioral interventions on medication adherence in HCV.~   "
44625|NCT02472912|"~     Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability~     of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous~     Injection in Healthy Adults.~   "
44626|NCT02472899|"~     The study aims to identify immune biomarkers in peripheral blood for identifying Alzheimer's~     disease (AD). Blood samples from subjects with AD will be compared to age-matched controls~     without cognitive symptoms, as well as healthy younger subjects.~   "
44627|NCT02472886|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV)~     in adults with chronic hepatitis C virus (HCV) infection.~   "
44628|NCT02472873|"~     The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during~     laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard~     cystectomy treatment - a prospective case control study.~   "
44629|NCT02472860|"~     The investigators will conduct a randomized placebo-controlled trial of a computerized~     intervention targeting cognition in 30 teens with autism spectrum disorder.~   "
44630|NCT02472847|"~     The goal of the current proposal is to investigate the effects of a cannabinoid drug on the~     memory of extinguished fear in humans and the brain circuitry important for the recall of~     extinction learning. The investigators findings will translate previous discoveries from~     animal studies to humans and increase their understanding of the neurobiological mechanisms~     supporting retention of extinction memory. This proof-of-concept study is a critical~     translational first step towards the development of cannabinoid modulators as an adjunctive~     strategy to exposure-based therapies to augment extinction learning and prevent the return~     of fear memories in patients with post-traumatic stress and other anxiety disorders.~   "
44646|NCT02472639|"~     The purpose of this study is to evaluate patient satisfaction and quality of life in~     patients with ileostomy managed with or without the novel Ostom-i Alert device.~   "
44647|NCT02472626|"~     This phase I/II trial studies the side effects and the best dose of~     6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with cytarabine and~     daunorubicin hydrochloride and to see how well it works in treating older patients with~     newly diagnosed acute myeloid leukemia. CPI-613 may kill tumor cells by turning off~     mitochondria (small structures in the cancer cells that are found in the cytoplasm [fluid~     that surrounds the cell nucleus]). Mitochondria are used by cancer cells to produce energy~     and are the building blocks needed to make more tumor cells. By shutting off mitochondria,~     CPI-613 may deprive the cancer cells of energy and other supplies that they need to survive~     and grow. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving CPI-613 together~     with cytarabine and daunorubicin hydrochloride may kill more cancer cells.~   "
44631|NCT02472834|"~     Patients with end stage renal disease (ESRD) usually have high levels of urea that may~     interact with blood proteins and change their structure by a process known as carbamylation.~     Evidence suggests that high levels of carbamylated proteins may be linked to adverse~     outcomes in dialysis patients. This is a randomized, open-label study to evaluate the~     effects of amino acid supplementation on levels of carbamylated proteins in ESRD patients.~     Secondary objectives will be to determine whether this intervention can modify intermediate~     markers of inflammation, cardiac stress, and erythropoietin responsiveness in this~     population. Sixty ESRD patients on dialysis will be randomized into two groups of 30~     patients each. Group 1 will receive intravenous supplementation with an FDA-approved amino~     acid solution (250 mL of NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3~     times weekly for 8 weeks); Group 2 will be treated according to standard-of-care (no amino~     acid supplementation). During the 8 weeks of therapy and for 4 weeks of follow-up, blood~     will be drawn from patients' existing hemodialysis access ports (~20 mL once per month) to~     measure levels of carbamylated albumin, amino acids, selected biomarkers, and standard~     laboratory values. Patients randomized to Group 1 will have fluid volume equivalent to the~     amino acid therapy removed by ultra-filtration to avoid net fluid gain. All patients will be~     monitored for safety (adverse events) and for changes in hemodynamics and dialysis~     prescription.~   "
44632|NCT02472821|"~     Farm and rural youth have frequent exposure to hazardous noise on the farm and~     recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There~     is a lack of programs to prepare this high-risk population to use hearing conservation~     strategies. This randomly-controlled trial of innovative community-based interventions is~     designed to compare effectiveness and sustainability of approaches to increase youths' use~     of hearing conservation strategies. Consistent use of hearing conservation strategies is~     expected to reduce rates of NIHL and other negative effects of high noise exposure, and~     improve quality of life in this high-risk and underserved group.~   "
44633|NCT02472808|"~     This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration)~     versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they~     are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite~     examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients~     visiting our hospital for evaluation of mediastinal lymphadenopathy.~   "
44634|NCT02472795|"~     International trial to evaluate the biological activity and safety of ACT-334441 in lupus~     patients.~   "
44635|NCT02472782|"~     This is a study aiming to investigate a possible correlation between the parameters~     affecting the physicians' therapeutic choice with the patients' overall adherence to~     osteoporosis treatment. Secondary end-points include correlation between the parameters~     affecting the physicians' therapeutic choice and the patients' quality of life as well as~     the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece~     (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).~   "
44636|NCT02472769|"~     Two different dose levels will be evaluated in two different birth weight categories,~     compared to placebo with regards to safety and tolerability.~   "
44637|NCT02472756|"~     This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously~     treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible~     participants with FL will receive 6-8 infusions of induction standard regimen of rituximab~     plus chemotherapy. Participants with complete or partial remission at end of induction will~     be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2~     years or until relapse. The choice of the treatment regimen will be established on a per~     center basis, according to the standard in use in the country and in the center, and each~     center will use the same regimen through the study. Participants will be followed up for~     safety and efficacy evaluation in accordance with routine practice.~   "
44638|NCT02472743|"~     Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and causes much~     pain and affects how patients use their hands. Our current treatments for digital ulcers are~     often not effective and have may have significant side effects (because they increase blood~     flow to the ulcer to try and help healing).~      Light-based treatment has been successfully used to treat chronic diabetic, pressure and~     venous ulcers. The investigators wish to investigate whether light-based treatment is a safe~     and effective treatment for digital ulcers in patients with SSc.~   "
44639|NCT02472730|"~     The purpose of this study is to identify if performing diagnostic colonoscopy with a small~     plastic cap attached to the camera will improve performance of colonoscopies by physician~     trainees.~   "
44640|NCT02472717|"~     Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the~     effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1~     receptor) agonist on joint and skin inflammation in patients with active Psoriatic~     Arthritis.~   "
44641|NCT02472704|"~     Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical~     and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria~     of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac~     gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue~     markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes~     expressing T-cell receptor (TCR) gamma/delta+.~      Aim: To demonstrate the existence of CGS in these patients despite having negative celiac~     serology.~      Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6~     months in patients with LE on a GFD. Inclusion criteria: >18 years, initial presentation~     with GI symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological~     response to GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin)~     (identical powder sachets mixed with meals). Clinical symptoms were analysed using visual~     analogue scales. Quality of life (GIQLI), adherence to diet, serology, and histological~     changes including gamma/delta+ IEL and tTG deposits were evaluated.~   "
44648|NCT02472613|"~     This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic~     post-stroke depression patients.The participants will be allocated randomly in either of the~     two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true~     medication group. On the hypothesis that acupuncture intervention could produce the same~     therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture~     would be associated with minimal side effects.~   "
44649|NCT02472600|"~     This investigator initiated,international, multicenter open-label, randomized controlled~     trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin~     sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day )~     followed by fecal microbiota transplantation (administered either via nasogastric~     administration or via capsules) is effective at eradicating intestinal carriage of~     beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing~     Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult~     non-immunosuppressed patients .~   "
44650|NCT02472587|"~     The purpose of this study is to determine the percentage of women, among those attending our~     institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the~     patients will be submitted to questionnaires.~   "
44651|NCT02472574|"~     The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of~     intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot~     lysis with rt-PA。~   "
44652|NCT02472561|"~     The purpose of this study is to understand the effects that a six month lifestyle-based~     mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on~     improving physical activity, fitness, important PAD risk factors and quality of life (QOL)~     in patients with PAD.~      By testing a novel mHealth intervention focused on lifestyle modification, this trial will~     address a critical evidence gap in the care of PAD patients. PAD patients are not eligible~     for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these~     patients currently have no lifestyle-based care strategies to help them. The results of this~     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based~     preventive care strategies for patients with stable PAD.~   "
44653|NCT02472548|"~     Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory~     Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of~     age.~   "
44654|NCT02472535|"~     A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in~     patients with Homozygous Familial Hypercholesterolemia (HoFH).~   "
44655|NCT02472522|"~     Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus~     abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean~     Section.~   "
44656|NCT02472509|"~     It is well established that hemolytic diseases predispose patients to the development of~     pigment gallstones. Gallstones are noted in at least 5% of children under the age of 10~     years, increasing to 40-50% in the second to fifth decades. The co-inheritance of Gilbert's~     syndrome increases the risk of cholelithiasis four to five-fold.~      In patients with chronic hemolysis, total bile lipid concentration is decreased and the~     total bilirubin to total lipid ratio is increased. This suggests that the conjugating~     capacity of hepatocytes is surpassed by the excessive amount of bilirubin resulting from~     hemolysis. Increased bilirubin monoconjugate and unconjugated bilirubin can precipitate in~     bile and form complexes with inorganic ions, mostly calcium, and develop into stones.~      Patients with hemolytic disorders can also develop biliary sludge, a suspension of~     precipitated particulate matter in bile dispersed in a viscous, mucin-rich liquid phase .~     The chemical composition of the precipitates correlates well with the composition of the~     associated stone and sludge often stands as a harbinger of future stone development.~      There is strong data suggesting a benefit in treating cholelithiasis with UDCA and also in~     preventing gallstone development in various high risk scenarios.~      There are several proposed mechanisms for the positive effect of UDCA in primary prevention~     of pigment stones. Mucoglycoproteins are present in significant amounts in black pigment~     stones and contribute to the matrix of gallstones. UDCA suppresses the secretion of protein~     and decreases the levels of various proteins in bile . It has also been suggested that~     increased colonic bile salt may solubilize unconjugated bilirubin and may prevent calcium~     complexing.~      There is no published data at present on the role of UDCA in prevention and treatment of~     cholelithiasis in hemolytic diseases. The investigators hypothesise that UDCA can be of~     benefit to patients with hemolytic disorders in the primary prevention of pigment stones,~     possible resolution of biliary sludge and existent stones, and reduction of symptomatic~     episodes of cholelithiasis.~   "
44657|NCT02472496|"~     The Korean Coronary Overlapping Stenting Registry is a multicenter database which includes~     percutaneous intervention using drug-eluting stents from cardiovascular centers in eight~     affiliated hospitals of The Catholic University of Korea~   "
44658|NCT02472483|"~     The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy~     (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations~     and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a~     large sample of refractory bipolar I patients on mood stabilizers.~   "
44659|NCT02472470|"~     Youth depression is a debilitating disorder that exacts enormous social, economic and~     personal cost. Unfortunately, treatments which are conventionally used to treat adult~     depression have often modest to no efficacy in youth and have side effects. Thus, there is a~     tremendous imperative to develop new treatments for youth depression. Investigators propose~     to examine the efficacy of a short form of repetitive transcranial magnetic stimulation~     (rTMS) for youth depression and examine its biological targets. This will be the first study~     examining the efficacy of a short rTMS protocol in youth diagnosed with depression who fail~     responding to or are intolerable to antidepressants. If the results are positive,~     investigators will have identified a novel treatment that may be both more efficacious,~     better tolerated and more acceptable treatment for youth depression. Finally, identifying~     the biological mechanisms leading to treatment efficacy will lead to more personalized~     treatments for youth depression and will be groundbreaking vis à vis understanding the~     mechanisms involved in this illness.~   "
44660|NCT02472457|"~     Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition~     of the gastrointestinal tract with a high risk for complications and need for surgical~     interventions, particularly in children. Immunomodulators and biologic therapies are~     effective at inducing and maintaining remission in pediatric CD, yet there is no proven~     strategy for reducing exposure to medications once sustained remission has been achieved.~     Diet has been proven to impact disease activity in CD and may allow for sustained drug-free~     remission. The primary objective of this study is to determine whether pediatric CD patients~     in long-standing remission remain in remission longer after stopping medications if they~     follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the~     CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.~   "
44706|NCT02471859|"~     This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and~     Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy~     Subjects.~   "
44711|NCT02471794|"~     The primary aim of this study is to examine the feasibility of implementing an evidence~     based patient engagement strategy, known as personalized health planning (PHP), in the~     context of a a shared medical appointment (SMA) for individuals with type II diabetes in a~     primary care setting.~   "
44661|NCT02472444|"~     Taste perception plays an important role in maintaining nutritional balance. Gustatory~     evoked potentials (GEP) can be detected in response to an intermittent stimulation of the~     gustatory receptors by a primary flavour. GEP are non invaisve, painless and safe.~      The aims were to establish a reliable recording of GEP in Humans and to determine~     physiological variations of the gustatory evoked cerebral activity, by recording gustatory~     evoked potentials in different physiological situations (different intensities of taste~     solutions, after feeding or fasting, with different taste...). Healthy volunteers were~     included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system),~     in front of the primary and the secondary gustatory cerebral areas, referenced against ear~     lobes.~   "
44662|NCT02472431|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time intracavernosally. This is a single arm~     study with no control. All patients receive cell therapy.~   "
44663|NCT02472418|"~     Crossover study of DFN15A versus DFN15B versus Placebo in the treatment of migraine~     headaches.~   "
44664|NCT02472405|"~     This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm~     Multiplex laser or no treatment results in a better outcome in the quality of the surgical~     scar using the multiplex cynergy laser, starting treatment the day of suture removal.~   "
44665|NCT02472392|"~     The purpose of this study is to examine the toxicity of using allogeneic stem cell~     transplantation for treatment of subjects with relapsed or refractory ES and~     rhabdomyosarcoma. This is a nanrandomized two-arm study is designed to determine the safety~     and incidence of graft versus host disease (GVHD) in patients with relapsed, refractory~     Ewings sarcoma receiving related and unrelated, allogeneic stem cell transplants.~   "
44666|NCT02472379|"~     UCLA researchers looking for healthy females (age 60+) to participate in a study~     investigating how writing about your experiences may be related to your health.~      Once a week for 6 weeks, participants will write about their experiences and fill out online~     questionnaires. Participants will also come to the UCLA campus for blood draws and to fill~     out questionnaires 3 times: once prior to the 6-week writing period, once immediately after~     the 6-week period, and once 2-months after the writing period.~   "
44667|NCT02472366|"~     A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients~     insufficiently responsive to available therapies.~   "
44668|NCT02472353|"~     The goal of this study is to determine if co-administration of metformin and doxorubicin in~     breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of~     patients who develop a significant change in left ventricle ejection fraction (LVEF).~   "
44669|NCT02472340|"~     In recent years, evidence has shown that mitochondrial dysfunction plays an important role~     in the development of age-related muscle decline that may lead to frailty.~      During aging, there is a progressive reduction in the cell's capacity to eliminate its~     dysfunctional elements by autophagy, as evidenced by the accumulation of oxidative damage~     and mutations in mitochondria and by the decrease in autophagic flux. In fact, it has been~     demonstrated that dysfunctional mitochondria can be specifically targeted for elimination by~     autophagy, a process that has been termed mitophagy.~      A major challenge in the clinic today is in the lack of validated tools, including~     biomarkers, to assess the decline in mitochondrial health associated with an impairment in~     muscle function. In the present study, the investigators will employ a battery of~     established and exploratory tests (clinical, physiological and molecular) to assess in vivo~     mitochondrial function and more specifically, the levels of mitophagy and autophagy, in the~     muscle of healthy and pre-frail elderly.~      It is anticipated that the results of this study will facilitate the rapid translation of~     interventions targeting mitophagy and autophagy for the improvement of muscle function.~   "
44670|NCT02472327|"~     Patient satisfaction after an unplanned cesarean section was studied and in the previous~     study it was noted that there were common themes that lead to patient dissatisfaction. The~     four common themes were: lack of trust regarding the indications for surgery, communication~     issues, loss of control, and fear during the situation. The purpose of this second phase of~     this study is to try and improve patient dissatisfaction by offering additional emotional~     support prior to the c/s with the hope of decreasing the trust issues toward physicians,~     decreasing the communication barriers, and decreasing the fear and loss of control. The~     additional emotional support that will be received prior to the cesarean section will be~     scripted based upon the findings of the investigators' prior study - the patient will be~     asked four questions and each question addresses the four themes that were noted in the~     previous study.~   "
44671|NCT02472314|"~     The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration~     into the shoulder to continues nerve block with Bupivacaine on postoperative pain control~     and functional outcomes.~   "
44672|NCT02472301|"~     To determine if 12 months of legume-based complementary foods is effective in reducing or~     reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35~     months to see if these improvements are correlated with specific changes in the enteric~     microbiome.~   "
44673|NCT02472288|"~     This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for~     the post-stroke patients with urinary retention under conventional treatments, compared with~     sham electroacupuncture.~   "
44674|NCT02472275|"~     This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase~     inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone~     therapy in treating patients with prostate cancer that is at intermediate or high risk of~     spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth, and may also help the~     radiation therapy work better. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     leuprolide acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made~     by the body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy~     and antihormone therapy may be a better treatment for prostate cancer.~   "
44675|NCT02472262|"~     To determine if 6 months of legume-based complementary foods is effective in reducing or~     reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months~     to see if these improvements are correlated with specific changes in the enteric microbiome.~   "
44676|NCT02472249|"~     Dr Rajan is investigating a new method to improve local treatment of liver cancer. There is~     evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood~     vessels, but leave tumor vessels wide open. In patients with primary liver cancer, NE will~     be injected directly in the artery that nourishes the liver and the tumor. Real time blood~     flow will be measured using an advanced CT scanner to demonstrate the NE effect on blood~     vessels. If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit~     patients during local delivery of chemotherapy in the liver artery, diverting it away from~     normal liver and towards the tumor, resulting in less complications and improved tumor kill.~   "
44677|NCT02472236|"~     To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy~     subjects.To provide a scientific basis for clinical drug combination of PEX168.~      To assess the safety of single doses of digoxin administered with and without PEX168~   "
44678|NCT02472223|"~     The primary aim of this pilot study is to generate data needed to design a definitive trial~     to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5%~     (5% povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no~     FDA approved treatment for pink eye, a common and highly contagious eye infection caused by~     adenovirus. Standard care as recommended by the American Academy of Ophthalmology and~     American Optometric Association is instillation of artificial tears to relieve symptoms and~     possibly reduce the virus population. Betadine 5% is a commercially available,~     broad-spectrum antiseptic ophthalmic solution used for over 50 years to prepare the~     patient's eye and surrounding area for eye surgery. Because Betadine 5% kills bacteria and~     viruses, it may be useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive,~     safe, widely available, and immune to the development of bacterial/viral resistance.~     Betadine 5% has the potential to significantly impact the clinical management of pink eye~     worldwide.~      This pilot study has received funding from the National Eye Institute. Participants who meet~     eligibility criteria will be randomized using a masked randomization packet to receive~     one-time, in-office treatment with either artificial tears or Betadine 5%.~      Patients who agree to study participation will answer questions about their pink eye~     symptoms, medical and ocular history, have an eye examination and be tested to confirm pink~     eye due to adenovirus using a FDA approved point of care immunoassay. Participants~     testing positive for adenovirus will have a tear sample taken to measure viral load by qPCR.~     Randomization and a one-time treatment with either (standard care) artificial tears or~     Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days.~     At each visit, symptoms of pink eye are asked, a standardized study eye examination is given~     by the masked clinician and a sample of tears is taken to assess viral load by qPCR.~   "
44679|NCT02472210|"~     Most Parkinsonism related pain can be assigned to one or more of five categories:~     musculoskeletal pain, neuritic or radicular pain, dystonia associated pain, primary or~     central pain, and akathitic discomfort. In PD pain tends to affect the side of the body that~     was initially, or more severe affected by the motor symptoms. Botulinum toxins are an~     effective treatment modality for a growing number of neurological conditions. They have been~     studied for a variety of conditions associated with PD including dystonia, jaw tremor,~     apraxia of eyelid opening, camptocormia, dyskinesias, freezing of gait, sialhorrea,~     overactive bladder and constipation. There are no studies for the use of Botulinum Toxin for~     pain in PD. The investigators will perform a double-blind, randomized cross-over study~     evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at~     painful muscles vs. placebo injection.~   "
44680|NCT02472197|"~     Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical~     procedure, the intrauterine pathology is resected by a transcervical approach in several~     fragments using a mono or bipolar cove after distension of the uterine cavity and by~     endoscopic control. The main risks of this surgery are: uterine perforation and OHIA~     (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are~     new intrauterine devices, recently appeared on the French market.~      In comparison to classical resectors, morcellators have several theoretical advantages:~        -  A smaller instrument diameter with potentially a lower risk of uterine perforation and~          cervical laceration during the dilatation procedure,~        -  The use of physiological serum, eliminating the risk of neurological toxicity of~          glycine,~        -  The risk of electrical accident is canceled (internal or external burns due to leakage~          current),~        -  A decreased risk of air embolism, due to the absence of bubbles' production,~        -  The instrument is always under visual control, the perforation risk by the active~          instrument is therefore very limited,~        -  The vision is not obscured by the fragments or by the bubbles,~        -  The treatment of pre-ostial pathologies, not always easy in classical resections, could~          be facilitated,~        -  the absence of thermal effect, and therefore a potentially lower endometrial~          aggression, is interesting in women with reproductive desire,~        -  Absence of chips management, limiting the entry and exit movements in the uterine~          cavity, improving the vision, reducing the infectious and traumatic risks, specially~          uterine perforation and air embolism,~        -  Morcellation could preserve tissues for histological analysis of possible malignancy~          (compared to techniques using heat, coagulation, vaporization),~        -  Easy learning in comparison to the time-consuming learning of classical hysteroscopic~          resection,~        -  Generated additional cost could be partly amortized by reducing operating time and~          complications.~      It seemed useful to study this new technology.~      The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps~     between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver~     (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope.~      The secondary purposes were to compare the efficiency, complications and comfort of these~     techniques.~   "
44681|NCT02472184|"~     This study will look at the optimal order in which to perform concurrent office hysteroscopy~     and endometrial biopsy in female patients who present for evaluation of abnormal uterine~     bleeding at a fibroid and endometriosis treatment center.~   "
44682|NCT02472171|"~     The overall goal of the research study is to determine whether a high-fat meal causes~     postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids~     (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the~     inflammation in healthy people.~   "
44683|NCT02472158|"~     The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing~     and the transparent polyurethane film dressing as coverage of the site of insertion of~     central venous catheter, in the evaluation of catheter colonization in critically ill adults~     patients.~   "
44684|NCT02472145|"~     The primary objective of study Part A is to assess the safety of talacotuzumab (formerly~     CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with~     acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary~     objective of study Part B are to assess complete response (CR) rate and overall survival~     (OS) in participants with AML who are not eligible for intense induction chemotherapy and~     who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine~     alone.~   "
44685|NCT02472132|"~     Central venous catheter (CVC) is an essential tool in the management of both medical and~     surgical patients. Establishing venous access is critically important and is sometimes~     technically challenging. Among the many indications for point of care ultrasound (POCUS),~     ultrasound-guided venous catheter placement is well described and increasingly used. This~     study was designed to evaluate the utility of peri procedural transthoracic echocardiography~     (TTE) as a tool for positioning CVC and for ruling out complications.~   "
44712|NCT02471781|"~     The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory~     safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is~     indicated for the treatment of patients with a descending thoracic aortic aneurysm or~     penetrating ulcer and has an anatomy suitable for repair.~   "
44686|NCT02472119|"~     Celiac disease is one of the most common forms of food intolerance (prevalence 1/200). The~     disease occurs in genetically predisposed individuals after ingestion of foods containing~     gluten. Celiac patients can suffer from severe malabsorption syndrome, mainly characterized~     by diarrhea and weight loss. The only therapeutic approach currently recognized is a~     life-long gluten-free diet.~      Specific regions of gluten molecule become recognizable by lymphocytes and activate them,~     due to changes made by tissue transglutaminase. These changes consist in the conversion of~     specific residues of glutamine into glutamic acid. The consequence is an increased binding~     affinity between gluten and histocompatibility molecule (HLA-DQ2), localized on the surface~     of the antigen presenting cells (APC); the exposure of the fragments of modified gluten on~     the surface of APC is a phenomenon that eventually activates T lymphocytes.~      Recent studies on modified gluten confirmed the hypothesis that it is possible to block the~     presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to~     those gluten regions responsible for lymphocyte activation.~      The enzymatic treatment is performed directly on flour instead of extracted gluten,~     maintaining the same anti-inflammatory effectiveness.~      The procedure uses a food-grade enzyme, the microbial transglutaminase (mTGasi) isolated~     from Streptoverticillium mobarensis, able to catalyze the formation of intermolecular~     cross-links that modify the functional properties of the products.~      Objective of the study is to validate the ability of the enzyme treatment of wheat flour~     with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients.~   "
44687|NCT02472106|"~     This study is designed to monitor the safety and performance of the V8 balloon when used as~     a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI)~     device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV),~     and is being investigated for an expanded intended use.~   "
44688|NCT02472093|"~     The aim of the investigators study was to measure reductions in chronic pain in female~     patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with~     perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized~     chronic pain condition that is usually accompanied by fatigue, sleep disturbance and~     psychological and cognitive alterations.~   "
44689|NCT02472080|"~     Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options~     are limited in this setting. Molecular targeted therapies have recently been developed for~     progressive disease and demonstrated clinical activity, especially with anti-angiogenic~     agents.~      For patients with contra-indication to these agents or in case of progression or toxicity~     during treatment, chemotherapy is usually proposed but this strategy has not been validated~     by prospective data.~      The investigators propose to conduct an open single arm phase 2 study to evaluate response~     rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for~     advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic~     agents or in case of contra-indication to anti-angiogenic therapy.~   "
44690|NCT02472067|"~     The main objective of this pilot project is to demonstrate the effectiveness of a~     psychologically-based physical therapy (PBPT) intervention for the prevention of disability~     in Active Duty Service Members who sustained a musculoskeletal injury (MSI) during~     deployment in support of combat operations on a carrier. This intervention is intended to~     optimize recovery and restore function in injured Active Duty Service Members.~      The three aims necessary to accomplish the main objective are:~        1. Demonstrate the feasibility of implementing PBPT on board a carrier;~        2. Document and compare risk factors related to disability from MSI aboard two carriers;~        3. Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness~          trial~   "
44691|NCT02472054|"~     The purpose of this project is to study the number of surviving patients until hematopoietic~     stem cell transplantation (HSCT) after first line treatment of hemophagocytic~     lymphohistiocytosis (HLH) by Alemtuzumab~   "
44692|NCT02472041|"~     This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in~     patients with chest tube. The study group received intermittent positive pressure~     intervention and the control group received incentive spirometry intervention associated~     with manual operation.~   "
44693|NCT02472028|"~     The purpose of the study is to test the hypothesis of slowing the progression of White~     Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints~     and a moderate to high grade of WML on brain MRI.~   "
44694|NCT02472015|"~     Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by~     identifying underlying causes and tailoring a treatment plan (pharmacological or~     non-pharmacologic treatments including provision of staff education and support, training in~     problem solving, and targeted therapy directed at the underlying causes for specific~     behaviors).~   "
44695|NCT02472002|"~     MES-HT is a pilot multicenter prospective study conducted in transplant patients who~     developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of~     bone marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping~     system.~      The main objective is to determine the effect of the administration of autologous~     mesenchymal cells of the bone marrow by intramyocardial injection on myocardial perfusion in~     cardiac transplant patients with severe coronary vasculopathy.~   "
44696|NCT02471989|"~     The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides~     Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented~     refractory GERD on proton pump inhibitor (PPI) therapy.~   "
44707|NCT02471846|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination~     of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic~     incurable solid malignancy that has progressed after available standard therapy or for which~     standard therapy is ineffective, intolerable, or inappropriate. Participants will be~     enrolled in two stages, including a dose-escalation stage and an expansion stage.~   "
44708|NCT02471833|"~     The purpose of this study is to determine if Telmisartan, an FDA approved blood pressure~     medication, may also have beneficial effects on Alzheimer's disease prevention in African~     Americans, who are at high risk for Alzheimer's disease.~   "
44740|NCT02471404|"~     This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin~     as an addition to metformin is effective and safe in treating patients with type 2 diabetes~     when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.~   "
44697|NCT02471976|"~     Rationale: Medicalized end of life rose profound society questions and debates. Major Laws~     and scientific society recommendations emerged from those reflections. These texts help~     withholding/withdrawing life-sustaining treatments allowing a palliative approach and to~     favor comfort treatments for end of life patients.~      Main Objective: To evaluate the impact of a procedure to support reflection on the level of~     therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after~     having identified vulnerability criteria early.~      Secondary objectives: To assess the usual care of the control group and the impact of the~     procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical~     patients concerned by a palliative strategy; the impact of an incentive approach on length~     of mechanical ventilation and length of stay in the ICU; To measure the extent of~     information collected concerning the collegial process; the impact of the procedure on~     caregivers' satisfaction; To count the number of identified conflicts Study type:~     Prospective, controlled, cluster randomized study of routine care Purpose: Study the~     implementation of the Act Leonetti released on 22 April 2005 calling for a compassionate~     approach and palliative care for patients at end of life.~      Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU~     during the study period Non-inclusion criteria: Patients hospitalized less than 24h;~     non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead~     patients (at the time of admission) Primary endpoint: Rate of deaths with palliative~     strategy (withholding or withdrawing treatments) Randomization process: each center is~     randomized adjusting on type of ICU (medical, surgical, mixed) and number of annual~     hospitalization volume.~        -  Control group: ICU usual care~        -  Intervention group: vulnerability criteria lead to reflection on level of therapeutic~          involvement, with the help of a written guide.~      Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data~     will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each~     time therapeutic strategy will change. Additional data will be collected for the~     intervention group according to the initial presence or the later apparition of predefined~     criteria, a standardized reflection procedure will start helped by the implementation of a~     guide for collegial approach and decision making.~      Length: 30 months~   "
44698|NCT02471963|"~     Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse~     wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk~     factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and~     obesity.~   "
44699|NCT02471950|"~     There is no clinical way of assessing the depth of anaesthesia while patients are on the~     heart-lung machine. A new method of measuring the depth of anaesthesia using brainwaves~     called the Bispectral index (BIS) has been developed and its use in cardiac surgery is now~     widespread. However BIS is also altered by patients body temperature. As cooling is common~     during heart surgery the use of BIS to measure the depth of anaesthesia during heart-lung~     bypass remains controversial. This study aims to find out what depth of anaesthesia is~     produced according to BIS during heart lung bypass using a standard anaesthetic technique~     that utilises the anaesthetic isoflurane.~   "
44700|NCT02471937|"~     Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and~     pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are~     defined in neonates by their occurring within or after the first week of life, respectively.~     Molecular epidemiological studies have identified a capsular serotype III clone, referred to~     as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal~     invasive diseases and for almost all cases of meningitis in LOD.~      The investigators working hypothesis is that host-environmental interactions may contribute~     to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this~     project the investigators will determine if reciprocal interactions between the intestinal~     microbiota and the innate and adaptive immune system may specifically facilitate the~     colonization of the neonate by the hypervirulent GBS CC-17 clone.~   "
44701|NCT02471924|"~     Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed~     by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of~     foetale and maternal suffering. It would be interesting to have a tool that could detect~     patient who are at risk to have hypotension.This study consist in measuring variations of~     under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output by~     Trans thoraciq echography.~   "
44702|NCT02471911|"~     This study evaluates the addition of selinexor (KPT-330) to RICE chemotherapy in the~     treatment of relapsed and refractory aggressive B-Cell Lymphoma, with the goal of improved~     response rates (as compared to RICE chemotherapy alone).~   "
44703|NCT02471898|"~     A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy~     and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following~     Bunionectomy~   "
44704|NCT02471885|"~     Cancer survival has improved steadily due to earlier detection and treatment. Despite the~     established efficacy of anthracycline chemotherapy, its damaging effects on the heart~     (cardiotoxicity) limits treatment and confers acute and long term adverse cardiovascular~     consequences. Protective strategies for the heart (cardioprotection) with iron binders~     (chelation), heart rate (beta blockade) and blood pressure (renin angiotensin inhibition)~     medications have demonstrated promise in adult cancer patients, but these treatments are~     typically prescribed only after significant changes in heart chamber size and pumping~     ability are detected by imaging investigations (myocardial dysfunction).~      Furthermore, these conventional therapies are constrained by important side effects that~     affect bone marrow, blood pressure, and the kidneys.~      Remote ischaemic conditioning (RIC) protects the heart by activating cell survival pathways~     through brief repeated inflations and deflations of a blood pressure cuff to limit blood~     flow temporarily (noninjurious ischaemia). These innate survival mechanisms prevent part of~     the cellular injury that occurs during the ischaemia reperfusion cascade during a heart~     attack (myocardial infarction). Ischaemia reperfusion injury also shares common biochemical~     pathways with anthracycline cardiotoxicity, and thus RIC may be a novel form of~     nonpharmacological cardioprotection that can be applied when undergoing anthracycline~     chemotherapy.~      The investigators propose a pilot single centre randomised controlled trial to investigate~     the effect of RIC on reducing heart muscle damage (myocardial injury) in~     anthracycline-treated cancer patients. The investigators will assess subclinical myocardial~     injury using high-sensitivity blood tests (troponin T levels) and advanced imaging~     techniques, monitor heart rhythm disturbances (cardiac arrhythmia) and analyse metabolic~     changes in urine and blood during chemotherapy, at specified time points, and follow up to 5~     years after completing chemotherapy treatment).~   "
44705|NCT02471872|"~     The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study~     is a pilot randomized control trial comparing the efficacy of a classroom-based intervention~     to no intervention in helping middle-school students understand and make behavioral~     decisions about air pollution. This study is designed to evaluate the effectiveness of the~     classroom-based intervention on knowledge of air pollution, understanding of air pollution~     sources, and behavioral choices made to reduce both contributions to air pollution and~     personal exposure to air pollution.~      It has been well established that pollution is a racial and economic issue. Low-income areas~     with populations of predominantly people of color tend to be those with the highest rates of~     pollution and the largest particulate exposure. Creation of and exposure to this pollution~     is a key issue for the health of inhabitants of these areas, and of those in the broader~     surrounding areas. By developing, and assessing the effectiveness of, the investigators hope~     that the BREATHE study will give the investigators insights into how to better combat this~     higher exposure and reduce the health risks for those in high pollution areas.~      The study will take place in 4 visits over a period of 12 months. The hypothesis is that the~     classroom-based intervention will be effective in leading to behaviors that will reduce~     exposure to air pollution.~   "
44713|NCT02471768|"~     Abstract~      Objectives:~      Primary: To study the association between central aortic blood pressure indices and coronary~     artery disease in patients undergoing elective angiography. Secondary: (a) To study whether~     any association exists between central aortic pressure indices and the incidence of major~     adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period.~     (b) To study whether any association exists between the central aortic pressures and~     peripheral pressures.~      Methods: The investigators conducted a prospective observational study in consecutive~     patients undergoing coronary angiography. Central and peripheral pressures were invasively~     recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive~     group. CAD severity was graded using the Gensini score and subjects were divided into~     tertiles. Patients were followed up and the role of central aortic pressure indices in the~     prediction of cardiovascular events were analysed.~   "
44714|NCT02471755|"~     This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT~     symptoms.~   "
44715|NCT02471742|"~     Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing~     mastectomy, allows to leave the nipple-areola complex intact and to provide a better~     cosmetic result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant~     chemotherapy, may theoretically appear suitable for this surgical option, alternative to~     conventional mastectomy or breast conserving surgery in case of unfavorable size of the~     breast, when a good response to neoadjuvant chemotherapy has been achieved.~   "
44716|NCT02471729|"~     Management of chronic heart failure (CHF) is a major public health problem. It is associated~     with high mortality, frequent hospitalization and represents a large cost to the health care~     system. Both pharmacological and non-pharmacological intervention haven't shown to be~     effective in reducing morbidity and mortality of these patients when able to modulate the~     activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data~     have emphasized the potential role of sympathetic renal denervation in patient with~     hypertension. CHF per se but even more CHF associated with comorbity lead to significant~     increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as~     chemo or baroflex abnormalities. These patients usually suffer from conditions which do not~     allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with~     chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be~     exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they~     thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic~     heart failure affects around 100 million people worldwild imposing a significant burden on~     health care system throughout the world. Even though symptoms are improved by heart failure~     therapy, they remain significantly disabling for many patients. Chronic over activation of~     the sympathetic nervous system is a major component of heart failure and involves efferent~     and afferent pathways between brain and many organs. A new therapy directly targeting nerve~     traffic-renal artery denervation- has been shown to be effective in drug resistant~     hypertension, with an average drop in blood pressure of 33/12 mm hg.~      The cardiologists team of the private hospital Arnault Tzanck is willing therefore to~     conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral~     renal denervation with an intensive protocol of observation and assessment compring a 3 day~     hospital stay post procedure 3 and 6 months of regular outpatient follow-up.~   "
44717|NCT02471716|"~     This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 in~     PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or~     Phase 2 (dose expansion) of the study, but not both.~   "
44718|NCT02471703|"~     This is a prospective, consecutive series, multicenter clinical study of clinical outcomes~     following total hip arthroplasty with the SMF stem.~   "
44719|NCT02471690|"~     The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a~     new formulation of oritavancin by adjusting infusion time, concentration and~     reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of~     oritavancin~   "
44720|NCT02471677|"~     The purpose of this randomized controlled trial (RCT) is to compare a single injection of~     corifollitropin-alfa versus daily injections of follitropin beta regarding the number of~     oocytes retrieved, hormonal profile and follicle development in patients with high response~     undergoing ovarian stimulation for in vitro fertilization treatment using a~     gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger~     and cryopreservation of all embryos.~   "
44721|NCT02471664|"~     To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for~     repair of functional mitral regurgitation.~   "
44722|NCT02471651|"~     Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly~     used treatment options for individuals with diabetic macular edema. However, some patients~     continue to experience persistent diabetic macular edema and poor vision despite continued~     laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory~     mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for~     individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth~     factor injections. The purpose of this research study is to compare the effectiveness of~     using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for~     research participants with persistent diabetic macular edema (DME).~   "
44723|NCT02471625|"~     The purpose of this research study is to evaluate whether data made by the ClearView System~     can be used to detect whether someone has a traumatic brain injury and how severe the injury~     is.~   "
44724|NCT02471612|"~     To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.~   "
44725|NCT02471599|"~     The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few~     prospective,randomized investigations have examined how tonsillectomy affects the shortterm~     and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled~     study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.~   "
44726|NCT02471586|"~     To demonstrate the safety and efficacy of an OCT guided strategy for stent implantation.~   "
44727|NCT02471573|"~     To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all~     protocol) with fresh embryo transfer (fresh ET).~   "
44728|NCT02471560|"~     The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes~     in the abundance and diversity of commensal microbiota. The secondary objectives of this~     study are as follows: To identify if there are differences in the gut microbiota composition~     between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both~     pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated~     patients is reflected in the gut microbiota.~   "
44780|NCT02470884|"~     A prospective multi-center, single arm feasibility study to assess the safety and~     performance of the Boston Scientific Fully Absorbable Scaffold.~   "
44729|NCT02471547|"~     Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for~     urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case~     of low-intermediate disease. Current literature advocate using intravesical instillations of~     Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence.~      During the last decade, heated intravesical instillations have emerged as additional~     players, in the treatment of recurrent disease. By most cases, the heated intravesical~     instillations are given either by microwave hyperthermia (synergo®) or by conductive heat~     bladder wall thermo-chemotherapy (BWT).~      Previous reports suggest up to 59% reduction rate in recurrence following~     thermo-chemotherapy upon recurrent disease. These outstanding reduction results haven't~     convinced significant amount of urologists worldwide to use the intravesical instillation~     close after endoscopic resection as TURBT, probably due to the fear of MMC adverse effects~     in an operated area or the fear of complications due to perforated bladder. Preliminary~     results have suggested favourable outcome when MMC is used prior to TURBT [see publication].~     To the investigators' knowledge no previous study has prospectively examined the effect of~     preliminary heated intravesical installation with BWT.~   "
44730|NCT02471534|"~     The purpose of this study is to evaluate predictability of an abdominal compression-induced~     change of blood pressure for fluid responsiveness in children.~   "
44731|NCT02471521|"~     The purpose of this study is to find an optimal inspiratory pressure to provide adequate~     tidal volume and prevent gastric insufflation in pediatric patients.~      The children under 5 years old are randomly assigned to muscle relaxation group and~     non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed~     with muscle relaxant and mask ventilation is started by pressure-controlled mechanical~     ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously~     during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10~     cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of~     two methods. Tracheal intubation is done after detection of gas.~      For non-relaxation group, mask ventilation is performed in a same manner, without muscle~     relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is~     administered and tracheal intubation is performed.~   "
44732|NCT02471508|"~     Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature~     on spine. Spine curvature increases in youths as puberty progresses. The recommended~     treatment for AIS is different depends on the spine deformity condition. For mild scoliosis~     (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the~     Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid~     plastic material restrict nearly all movements of the wearers, which caused irritation.~     Flexible brace is an alternative option, however, the efficiency of such treatment is~     questionable in terms of controlling the spine curvature progression.~      Biofeedback has proven to be effective for a number of physical, psychological and~     psychophysical problems. The basic aim of biofeedback therapy is to support a patient in~     realizing his/her self-ability to control specific psychophysiological processes.~      In this study, a biofeedback embedded tank-top with a specialized design for adolescents as~     a treatment option for AIS patients by monitoring the daily posture of the wearers.~   "
44733|NCT02471495|"~     This multicenter, prospective, single-arm, phase 3 study will assess the proportion of~     disease-free patients, starting from administration of the first study treatment to at least~     12-months after the first treatment, and up to 2 years (the latter only in patients choosing~     to participate in longer-term disease-free-survival data collection).~   "
44734|NCT02471482|"~     This study is intended to see the effect of Mozart music on oxygen content of brain of~     premature infants once they achieve corrected gestation of 28-32 weeks and are clinically~     stable. Each baby is its own control. Difference of Oxygenation of brain will be measured~     during period with and without music. In addition behavioural response of baby will be~     recorded during intervention~   "
44735|NCT02471469|"~     The primary aim is to show whether a reduction in tumor related mRNAs and a panel of~     selected miRNAS can be used to personalize enzalutamide therapy.~      Furthermore the aim is to explore the relation between drug exposure and the decrease in the~     selected biomarkers and treatment response.~   "
44736|NCT02471456|"~     Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous~     vein (LSV) harvesting from the leg. This has been reported to be associated with a~     significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to~     50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated~     with a reduction in these complications was implemented within the investigators' service in~     2012. Although some initial reports of concerns regarding graft patency when the LSV is~     harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported~     the use of the EVH technology. Last year a service evaluation in the investigators'~     department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in~     a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this~     group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular~     event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will~     be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire~     (SF12v2) will be sent to patients along with a patient information sheet. It is estimated~     that data collection would be completed within 3 months of start.~   "
44737|NCT02471443|"~     To determine the quality of life following the radical excision of recto-vaginal~     endometriosis.~   "
44738|NCT02471430|"~     This study is a prospective, open-label, randomized, two-arm, dose-escalation exploratory~     pilot clinical trial involving HIV-1 infected participants treated with suppressive~     combination antiretroviral combination therapy (cART). The study will test whether combined~     treatment with the histone deacetylase inhibitor panobinostat and the immunomodulatory~     cytokine Interferon-alpha2a can reduce the residual reservoir of HIV-1 infected cells that~     persist during treatment with currently available antiretroviral drugs.~   "
44739|NCT02471417|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise~     capacity in athletes, healthy adults and subjects with both peripheral vascular disease or~     COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The~     investigators hypothesized that acute nitrate consumption might increase incremental shuttle~     walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot~     juice.~   "
44741|NCT02471391|"~     This research will test the combination of two new drugs, called ibrutinib and ABT199, taken~     together in the treatment of Mantle Cell Lymphoma. Other studies have indicated the~     potential for these drugs to be used in the treatment of participants with Mantle Cell~     Lymphoma. In this study, the investigators will test the combination of the two drugs~     together, in order to determine what effects (good and bad) it has on mantle cell lymphoma.~      This study has two phases. The first phase is the Primary Evaluation Phase and will closely~     monitor the effects of ibrutinib and ABT199 for a period of 13 months. Participants who~     complete 13 months of treatment and continue benefiting from the study treatments will be~     allowed to continue both drugs until progression or intolerance in the Continuation Phase.~     The purpose of this phase is to provide patients with continuing access to both ibrutinib~     and ABT199. Patients will receive routine care from clinician, who will record any~     sideeffects that may be experienced.~      This is one of the first trials in the world to study the combination of ibrutinib and~     ABT199 together. Therefore the effectiveness of the combination of the study drugs will be~     assessed, as will how they affect mantle cell lymphoma and how it develops resistance to the~     treatments. The investigators also do not know whether combining the two drugs together will~     cause unexpected side effects. Therefore, the study will monitor patients closely and~     perform scans, blood tests, bone marrow biopsies and other tests at regular intervals.~   "
44742|NCT02471378|"~     Background:~      - Malaria is a disease that affects many people in African countries. It is caused by germs~     that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away.~     Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want~     to create a vaccine that will prevent malaria infection during pregnancy.~      Objectives:~      - To create a vaccine that will prevent malaria infection during pregnancy. To assess~     possible vaccines using in-vitro tests with parasites taken from pregnant women.~      Eligibility:~      - Pregnant women ages 15 25~      Design:~        -  The study site is an area in Mali, West Africa.~        -  Participants:~        -  Will have blood drawn.~        -  Will give consent for the blood sample to be used for future research.~        -  May have a physical exam.~        -  Participants who have malaria or anemia will get treatment.~   "
44743|NCT02471365|"~     Background:~      - In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients~     in the products they buy. It s not easy to measure them because the companies that sell the~     products don t have to tell the exact chemical ingredients. Researchers want to compare how~     existing methods (e.g., surveys and models) measure exposure to chemicals in personal care~     and household products.~      Objective:~      - To test and improve the ways that studies gather data about contact with chemicals found~     in consumer products.~      Eligibility:~      - Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.~      Design:~        -  Participants will be screened with medical history, pregnancy test, smoking test, and~          blood sample. They will answer questions about their homes and products they use.~        -  Participation will last about 30 hours over 12 days.~        -  Researchers will:~        -  Place air samplers inside and outside participants homes for 10 days. One sampler will~          need to be plugged into an electrical outlet. It will make a low, continuous sound~          while in operation.~        -  Collect house dust samples and record all consumer products in the house.~        -  Visit the house daily to collect samples.~        -  Participants will:~        -  Give a blood sample at a clinic twice.~        -  Collect all urine voids for 10 days. They will label it and put it in a special cooler.~        -  Wear 4 small devices that measure air pollution, chemicals, location, and activity.~        -  Record what they eat and what consumer products they use. They will write these in a~          diary and <TAB>photograph them on an iPhone provided to them.~        -  On day 2 of the study, they will collect a duplicate sample of what they eat.~        -  Take iPhone videos of their use of certain products.~        -  Answer questions about chemical ingredients in their personal care products.~   "
44744|NCT02471352|"~     Background:~      - Skin disease can have many causes. It can have widespread consequences, and in rare cases~     can lead to death. Researchers want to determine the causes of various types of skin~     diseases and find a way to treat them.~      Objectives:~      - To determine the causes of various skin diseases and find ways to treat them.~      Eligibility:~        -  People ages 2 and older who have:~             -  A skin disease or at risk of developing a skin disease OR~             -  A family member of persons with a skin disease~        -  Healthy volunteers ages 2 and older~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants may take a survey about how their skin condition affects their quality of~          life.~        -  Participants will have a medical history and a physical exam including a detailed skin~          exam. Pictures will be taken of their skin to document any skin disease.~        -  Participants will have specimens collected. This may include:~             -  Several teaspoons of blood taken at each visit~             -  Stool samples~             -  Nail and body fluid (like saliva) samples~             -  Cheek swabs. The inside of the cheek will be scraped for about a minute in each~               direction to collect cells.~             -  Collection of skin samples with:~                  -  A swab (like a Q-tip)~                  -  Gently scraping skin to remove the outer layers of cells~                  -  Applying and removing 1-inch pieces of tape~        -  Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies~          taken each time.~             -  An area of skin will be numbed with an injection.~             -  A piece of skin the size of a pencil eraser will be removed using a small~               instrument.~             -  A flat scar usually develops at the biopsy site.~   "
44745|NCT02471339|"~     Background:~      - People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often~     have chronic pain that his hard to control. People usually take medicines for the pain, but~     they may not work well and might cause side effects. A new strategy called Acceptance and~     Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on~     things like values and living in the moment.~      Objective:~      - To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.~      Eligibility:~      - People age 16 34 who have NF1, 1 or more PN tumors, and pain that interferes with their~     daily functioning.~      Design:~        -  Participants will be screened with a physical exam, medical history, and questions~          about their pain.~        -  Participants will fill out questionnaires about their pain and feelings. Their heart~          rate will be measured via ECG.~        -  Participants will be divided into 2 groups randomly. One will wait 8 weeks.~        -  The other will start training right away.~        -  Participants will have 2 two-hour sessions with an ACT trainer. They will learn~          techniques for setting goals based on personal values and other ways to cope with pain.~          They will get a workbook and a CD to take home for practice.~        -  Participants will do practice exercises at home between sessions. They will get weekly~          emails with a practice exercise. They will join video chat sessions via home computer~          with their trainer.~        -  All participants will return to NIH after 8 weeks for questionnaires and an ECG. The~          wait group will then start training. They will return 8 weeks later for questionnaires~          and an ECG.~        -  Six months later, they will complete questionnaires from home by computer.~   "
44746|NCT02471326|"~     Background:~      - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV)~     very low for a long time. But cART can lose effectiveness and cause permanent side effects.~     If treatment stops, HIV levels go up again. Researchers want to see if a new product can~     control HIV levels when a person is off cART.~      Objective:~      - To see if the new product VRC01 is safe and can control the HIV level in the blood when a~     person is not taking cART.~      Eligibility:~      - Adults ages 18 65 with HIV who are willing to interrupt their treatment for at least 24~     weeks.~      Design:~        -  Participants will be screened with:~        -  Physical exam~        -  Medical history~        -  Heart tests~        -  Blood and urine tests.~        -  Their HIV drugs may be switched. They will keep taking them until a few days after~          Visit 1.~        -  Visit 1: Repeat screening procedures.~        -  Participants will also have genetic testing and leukapheresis. For this, blood will be~          removed through a needle in one arm and circulated through a machine that removes white~          blood cells. The rest of <TAB>the blood is returned through a needle in the other arm.~        -  They will get the first study drug dose through a thin tube in an arm vein for about 1~          hour.~        -  For 24 weeks, participants will have 15 visits. They will have blood drawn every visit.~          At some visits they will repeat the screening procedures and get another VRC01 dose.~          They may have another leukapheresis.~        -  Four weeks after the last dose, participants will restart their cART. For 20 weeks,~          they will have monthly visits to repeat the screening procedures and discuss new~          symptoms.~   "
44747|NCT02471313|"~     Background:~      - Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also~     include other minimally invasive tumor treatments such as transarterial chemoembolization~     (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a~     cure. Researchers want to learn more about the effects of TACE on liver tumors and~     surrounding tissue. To do this, they will use a positive emission test (PET) and a~     radioactive tracer called [18F] FMISO.~      Objectives:~      - To see if [18F] FMISO is useful for evaluating what happens to liver tumors and~     surrounding tissue after TACE.~      Eligibility:~      - People age 18 and older with liver cancer who have been approved to have TACE.~      Design:~        -  Participants will meet with a study researcher to see if they can take part in the~          study.~        -  Participants will have TACE under a separate NCI protocol or at a hospital other than~          the NIH Clinical Center.~        -  Before and after TACE, participants will have a CT and MRI of the abdomen. For these~          scans, they will lie in a machine that takes pictures of their body. They will also~          have blood tests and a physical exam.~        -  The [18F] FMISO imaging study will be performed at NIH only.~        -  Participants will have an intravenous catheter placed in their arm (if they do not have~          one). The [18F] FMISO tracer will be injected.~        -  Participants will have PET-CT scans. Each scan will take about 30 minutes.~        -  Some participants will also have [18F] FMISO and PET-CT scans before TACE.~        -  As part of standard care for TACE, participants will have CT and MRI scans at regular~          intervals. This will evaluate tumor response.~   "
44748|NCT02471300|"~     Background:~      Research shows that restricting calories has a positive effect on immune cell health in~     healthy people. Researchers want to learn if it will help people with asthma. They want to~     better understand how the body s immune response and lung function responds to short-term~     calorie restriction. For this, they want people to fast (no food or drink except water) for~     24 hours.~      Objective:~      To explore the benefits of calorie restriction in people with asthma.~      Eligibility:~      Healthy people ages 18 to 60 who have a history consistent with asthma and prior~     documentation of airflow obstruction or wheezing.~      Design:~        -  Participants who have taken part in asthma research at NIH will be screened with a~          telephone interview. All other participants will have a medical history, blood tests,~          and physical exam.~        -  Eligible participants will return to the NIH Clinical Center one morning for 2 hours.~          They will be fed breakfast. They may have blood and urine tests.~        -  Participants will then fast for 24 hours.~        -  Participants will return to the Clinical Center the next morning for 4 hours. They will~          have blood drawn. They will eat breakfast and then repeat blood draws 2.5 hours later.~          They will have a urine test.~        -  Blood and urine tests will be done at the end of the fast and after the meals to~          confirm that the participant fasted for the full 24-hour period.~        -  Participants will have lung function tests and exhaled gas measurements. A machine will~          measure the volume of air they can breathe out. Some gases in the breath increase with~          inflammation. Participants will breathe into a machine that analyzes the gases in their~          breath.~   "
44749|NCT02471287|"~     Background:~      Research has identified some of the genes involved in inherited eye diseases. But for many~     of these diseases, the genes are not yet known. Researchers want to try to find these genes.~     They also hope to learn more about how symptoms differ in people with similar gene changes.~      Objective:~      To learn more about genes involved in eye diseases.~      Eligibility:~      People who have a known or suspected inherited eye disease, and their relatives.~      Design:~        -  All participants will have a medical history, physical exam, and eye exam. They may~          have blood taken.~        -  Participants with an eye disease may have eye cell samples taken using a swab or biopsy~          procedure.~        -  Participants may have a skin biopsy. A (Omega)-inch piece of skin will be removed.~        -  Participants may have blood drawn and the red blood cells removed. The remaining serum~          will be made into an eye drop solution for the participant.~        -  Participants may provide samples of tears, urine, saliva, stool, hair, or inner cheek~          cells.~        -  Participants may have a retina test. They may also have a test that uses light to~          measure retina thickness.~        -  Participants may have an eye movement test. Electrodes will be placed on the skin next~          to both eyes.~        -  Participants may have a fluorescein angiography. A dye will be given through an~          intravenous line in the arm. A camera will take pictures of the dye as it flows through~          the eyes blood vessels.~        -  Participants may have microperimetry. They will sit at a computer screen and press a~          button when they see a light.~        -  Participants may have an eye movement test. They will wear contact lenses or goggles~          and watch a series of spots on a computer screen.~   "
44750|NCT02471274|"~     To evaluate the effect of mild, moderate, or severe hepatic impairment on the~     pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared~     with healthy, demographically-matched subjects.~   "
44751|NCT02471261|"~     Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.~   "
44752|NCT02471248|"~     A novel interactive exoskeleton robotic system with embedded force and motion sensors will~     be developed to facilitate walking of stroke patients with hemiparesis. The robot will~     synchronise with the gait pattern of the stroke patient to provide assistance in ankle~     dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and~     longer walking distance for stroke patients with drop foot problem. It can be applied on~     unilateral side, which is suitable for stroke patients with hemiparesis. The whole system~     design is lightweight, compact, comfortable, and user-friendly in hospital or at home~     settings.~   "
44753|NCT02471235|"~     This study assessed whether a short course pulmonary rehabilitation programme with periodic~     reinforcement exercise training and phone call reminders would help to increase physical~     activity in COPD patients and also decrease readmissions for AECOPD.~   "
44754|NCT02471222|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study of ADS-5102 extended release (ER) capsules, an investigational formulation of~     amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS.~     ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher~     plasma amantadine concentrations in the early morning, sustained throughout the afternoon,~     and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to~     deliver its primary treatment effect during the day, and potentially reduce the adverse~     events of immediate-release amantadine when the patient is asleep.~   "
44755|NCT02471209|"~     To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial~     buffer response (HABR) in infants with obstructive jaundice by Doppler~     ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a~     Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow~     (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction,~     and after inhalation of 2 and 3% sevoflurane.~   "
44756|NCT02471196|"~     This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's~     disease. Two thirds of the patients will receive ORM-12741 and one third will receive~     placebo.~   "
44757|NCT02471183|"~     This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled~     treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off~     and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a~     similar way. The purpose of the study is i) to investigate the safety and tolerability of~     oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the~     effects of oral selexipag on PAH severity and exercise ability before and after transition,~     and iii) to gain new information about the patients experience taking oral selexipag~     compared to inhaled treprostinil. Study participants may stay in the study until the FDA has~     granted marketing authorization.~   "
44758|NCT02471170|"~     The purpose of this study is to collect blood samples to detect potential markers of~     pancreatic cancer in the blood and link these findings to medical and health information.~     Information from this study may help to provide insight into the detection of pancreas~     cancer in the blood before it can be found by other methods or provide a method of~     monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of~     this study is to collect blood to create a biobank.~   "
44759|NCT02471157|"~     An observational trial to determine whether preoperative hormonal status predicts outcomes~     of oncologic surgery.~   "
44760|NCT02471144|"~     This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept~     in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with~     severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will~     be enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that~     subjects will be enrolled at approximately 70 study sites worldwide.~   "
44761|NCT02471131|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of~     developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of~     AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality.~     The left atrial appendage (LAA) is the origin for more than 90% of the emboli in~     non-valvular AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston~     Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for~     AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It~     thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device~     implantation in a hybrid ablation approach.~   "
44762|NCT02471118|"~     This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed~     to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat~     subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of~     inflammation, whose pain persists despite receiving maximum tolerated doses of conventional~     therapy.~   "
44763|NCT02471105|"~     This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a~     clinical setting.~   "
44764|NCT02471092|"~     The purpose of this study is to develop and test modified milk protein products to determine~     the effects of amino acids on food intake, satiety, insulin secretion and glucose control by~     insulin-independent action in healthy adults.~   "
44765|NCT02471079|"~     Rationale:~      The number of breast cancer (BC) patients at risk for long-term radiation-induced health~     problems is increasing, as their outcome is improving due to intensified treatment regimens,~     such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with~     the highest risk for radiation-induced health problems is crucial for developing strategies~     for primary and secondary prevention, which may contribute to healthy ageing.~   "
44781|NCT02470871|"~     The purpose of this study is to investigate the pharmacokinetics (PK) and safety of rVIIa-FP~     (CSL689) in a total of 10 to 16 male or female adults with inherited coagulation factor VII~     (FVII) deficiency. Subjects will receive a single dose of their routine FVII replacement~     product (ie, either recombinant activated coagulation FVII [rFVIIa, eptacog alfa~     (activated)] or plasma-derived FVII [pdFVII]) as a comparator, and will then be randomly~     assigned to a single low dose or a single high dose of the study product CSL689 (8 subjects~     per CSL689 dose level). Serial blood samples for PK analysis will be taken up to 24 hours~     after the eptacog alfa (activated) or pdFVII injection, and up to 48 hours after the CSL689~     injection. Subject safety will be routinely monitored throughout the study.~   "
44766|NCT02471066|"~     The management of functional psychogenic movement disorders (FNPMD) is challenging for~     neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme~     can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic~     resonance imaging studies have demonstrated abnormalities in motor control at cortical~     level, hyperactivity of limbic system and disturbance of connectivity between these two~     systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies~     suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD~     (Dakotakis 2011, Garcin, 2013).~      In this protocol our objectives are twofold :~        1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a~          double-blind randomized controlled study~        2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD~   "
44767|NCT02471053|"~     As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are~     becoming increasingly apparent. Most prominent are the toxic effects on the heart~     (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular~     disease (CVD). The investigators hypothesize that an individualized aerobic training program~     for cancer patients receiving active treatment will be both feasible and safe and will~     result in improvements in overall levels of physical activity and quality of life.~      Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates,~     along with program safety. Efficacy will be assessed by evaluating changes in health-related~     outcomes.~   "
44768|NCT02471040|"~     This study is designed to examine the value of infusing BHB in type 1 diabetic subjects~     during experimentally induced hypoglycemic episode in conjunction with testing of cognitive~     function. This will lay the basis for subsequent trials exploring the novel use of~     therapeutic doses of oral ketone formulations that are currently under commercial~     development, which could serve as adjunct therapies to protect the brain from hypoglycemia~     in type 1 diabetic subjects experiencing recurrent hypoglycemia.~   "
44769|NCT02471027|"~     This study is a registration study.The main research: the curative effect of neoadjuvant~     chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research~     group: the neoadjuvant chemotherapy in combination with cervical cancer radical~     hysterectomy.Control group:cervical cancer radical hysterectomy directly.Main observation~     indexes is overall survival and disease-free survival.~   "
44770|NCT02471014|"~     Pneumococcal infections are a leading cause of adult and childhood hospitalization and~     death. It has been shown that obese individuals are at higher risk for this bacterial~     infection. As a result, investigators will vaccinate obese individuals to see if they are~     offered the same level of protection from the vaccine as normal-weight individuals. The~     vaccine used for this particular bacterial infection is called Pneumovax 23.~      The purpose of this study is to compare how body mass index affects protection that the~     vaccine provides against these bacteria.~      Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post-~     vaccination in healthy BMI individuals and obese individuals.~   "
44771|NCT02471001|"~     In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some~     benefits to reduce the risk of heart muscle damage. Many research studies have been~     conducted to reveal the benefit relationship between Isoflurane and the risk of heart muscle~     injury during heart surgery. However, there is a knowledge gap regarding the optimal level~     of Isoflurane concentration to confer the benefit of heart muscle-protective properties.~     Therefore, this study is conducted to answer that question by measuring the Isoflurane~     concentration in the blood vessels. It also assesses whether Isoflurane concentration in the~     blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.~   "
44772|NCT02470988|"~     The purpose of the study is to investigate the process of symptom change in Cognitive~     Behavioural Analysis System of Psychotherapy (CBASP), and how the individual components of~     the therapy affect this change in individuals with chronic depression.~   "
44773|NCT02470975|"~     Children with newly diagnosed cancer and their parents will be contacted and invited to~     participate. Upon agreement, children will be interviewed, both parents will fill out~     questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly~     self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC)~     and parent-child DC during a course of 12 months will be examined. Additionally, during~     brief separate interviews, the parents' speech will be coded for we-appraisals and expressed~     emotion regarding the other partner and the child. Findings will provide information on how~     family variables affect child QoL over 12 months.~   "
44774|NCT02470962|"~     This study evaluates the function of the heart in young patients with muscular dystrophy~     type Duchenne or Becker. Participants have their hearts examined at regular intervals by~     ultrasound (echocardiography) and cardiac magnetic resonance imaging.~   "
44775|NCT02470949|"~     This project will investigate the influence of experimentally manipulated perceived social~     standing on eating behavior and obesity risk.~   "
44776|NCT02470936|"~     A randomized controlled trial of a technology-based lifestyle intervention vs. usual care~     among men with low-risk prostate cancer to determine the acceptability and feasibility of~     the intervention and the effect of the intervention on behavior change related to exercise,~     diet, and not smoking.~   "
44777|NCT02470923|"~     The objective of the study is to assess the effect of in-hospital intensive counseling and~     NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to~     smoking cessation behavioral intervention.~      This is prospective randomized clinical trial. The study population will include smokers~     subjects admitted to internal medicine departments at Soroka University Medical Center.~      The study population will be divided randomly into three arms according to intervention~     intensity (ratio 1:1:1).~   "
44778|NCT02470910|"~     This research study is evaluating whether a standard prostate MRI examination can improve~     radiation therapy planning for prostate cancer.~   "
44779|NCT02470897|"~     This phase I/II trial studies the side effects and best dose of stereotactic body radiation~     therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid~     radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation~     therapy is a specialized radiation therapy that sends x-rays directly to the tumor using~     small, high doses of radiation over several days and may cause less damage to normal tissue.~     This treatment schedule allows for a higher dose of radiation to be administered over a~     shorter overall treatment period in comparison to standard radiation therapy.~   "
44784|NCT02470832|"~     The study is being conducted to investigate the effect of itraconazole treatment in the~     pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response~     relationship and the safety and tolerability of RG1662 when given in combination with~     itraconazole in healthy subjects.~   "
44785|NCT02470819|"~     The primary objective is to examine the impact on progression-free survival of targeted~     therapy for breast cancer suggested by proteomic and genomic profiling.~   "
44786|NCT02470806|"~     The aim of this study is to compare the clinical efficacy of two types of NPWT systems;~        -  tNPWT systems that has successfully completed a coding verification request with CMS~          and has the following capabilities (e.g., range of negative pressure, connective~          tubing, canister, foam or gauze filler, and approved for home use) and,~        -  a portable, canister-less, battery operated, disposable single-use NPWT system (PICO)~          to see if there are any observed differences with regard to the clinical efficacy of~          the two devices.~   "
44787|NCT02470793|"~     To assess and compare the complications and results of different lamellar endothelial~     keratoplasty techniques and its variations.~   "
44788|NCT02470780|"~     This study investigates the effect of treating Small Intestinal Bacterial Overgrowth (SIBO)~     in patients with Parkinson's Disease (PD). It will test the hypothesis that treating SIBO~     with the antibiotic rifaximin will improve motor complications in previously SIBO-positive~     PD patients.~   "
44789|NCT02470767|"~     describe the sociodemographic and clinical characteristics of patients diagnosed with~     non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on~     anticoagulant therapy who have changed their therapeutic regimen, due to any clinical~     situation, based on the doctor's routine clinical practice and are currently on treatment~     with a direct oral anticoagulant (DOAC)~   "
44790|NCT02470754|"~     The purpose of this study is to learn more about nicotine exposure and the safety of~     electronic cigarettes (EC). It will focus on the areas that are thought to most closely~     relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices,~     covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and~     titration of nicotine; and (2) subjective effects of EC use, including relationship of use~     to reward, withdrawal and craving.~   "
44791|NCT02470741|"~     PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a~     randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women~     with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to~     either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole~     2.5mg/day and an identical placebo capsule (Group B).~   "
44792|NCT02470728|"~     Pain is a symptom that drives hospital admissions, and pain management is required by most~     patients during their stay at the UC Irvine Health (UCI Health). Further, the use of~     medications such as opioids can lead to upward-spiraling doses, especially among chronic~     pain patients whose resource utilization rates are high. Many initiatives aim to reduce the~     costs of these high-resource utilizing patients. One exciting aspect of improving the~     management of pain is that this may help prevent patients from ever becoming high-cost in~     the first place. The purpose of this study is to examine the impacts of an early~     intervention pathway, in comparison to the current standard of care, for the treatment of~     pain in opioid tolerant patients. It is hypothesized that patients randomized to the early~     intervention pathway, in comparison to the control, will lead to decreased costs of care, a~     reduction in opioid usage within 3 and 6 months, and decrease in hospital readmission rates.~   "
44793|NCT02470715|"~     The primary aim of this study is to identify drivers of cancer by performing comprehensive~     genetic, proteomic, and metabolomic characterization of patient samples as a basis for~     understanding the underlying cause of disease.~   "
44794|NCT02470702|"~     This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of~     multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.~   "
44795|NCT02470689|"~     Epidermolysis bullosa simplex type Dowling-Meara (EBS-DM) is one of the most severe subtypes~     of EBS. Blisters and erosions of the skin and mucous membranes upon minor trauma are the~     consequence of dominantly inherited mutations in either the keratin 5 (K5) or keratin 14~     (K14) gene, which encode proteins constituting the intermediate filament (IF) network in~     basal keratinocytes . Autosomal dominant mutations lead to a conformational change and an~     increased self-aggregation of the protein. Upon stress, aggregates present in the periphery~     of the cytoplasm, subsequently leading to the disintegration and collapse of the IF network.~     Clinically, patients suffer from blistering of the skin and mucous membranes upon minor~     trauma, resulting in an impaired life quality due to pain and pruritus . In vitro studies on~     Dowling-Meara keratinocytes revealed a significant upregulation of the pro-inflammatory~     cytokine interleukin-1beta (IL-1ß). Apart from paracrine effects of IL-1ß upon wounding~     (e.g. attraction of lymphocytes, activation of dermal fibroblasts), IL-1ß also activates~     keratinocytes via the cjun N-terminal kinase (JNK) stress pathway. The activation of this~     pathway leads to the activation of a number of transcription factors and the enhanced~     transcription of a number of genes, like matrix metalloproteinases, kallikreins, but also~     IL-1ß itself and K14 . Interestingly, this state of activation is constitutive and was also~     found in keratinocytes from non-lesional sites. It seems that the upregulation of IL-1ß and~     K14 in the presence of dominant Dowling-Meara mutations, results in a positive feedback~     loop, potentially aggravating the EBS-DM phenotype. This was strongly corroborated by the~     fact that when impairing IL1ß signaling, using IL-1ß neutralizing antibody (IL-1Ab) or the~     small molecule diacerein, expression levels of IL-1ß and K14 decreased and keratinocytes~     were much less susceptible to heat shock in vitro . Furthermore, activation levels of JNK~     widely correlated with expression levels of K14 and IL-1ß. (Wally V et al, 2013). These~     findings led to the hypothesis that blocking IL-1ß will also lead to an amelioration of the~     EBSDM phenotype in effected patients. Based on previous in vitro findings diacerein was~     chosen to be topically applied in a pilot study with five patients suffering from EBS-DM. In~     that study , each participant received 1% diacerein-cream for one armpit, and placebo for~     the other (randomized withdrawal). The number of blisters was reduced significantly (left:~     -78%; right: -66% of baseline) within two weeks and remained significantly below the initial~     level even during withdrawal in four patients. These findings pointed to a relevant effect~     of diacerein and provide important information for our confirmative study.~      Diacerein is a component of the rhubarb root, which is reported to block the release of~     active IL-1b by inhibiting plasma membrane-bound IL-1 converting enzyme . Diacerien is~     already approved for systemic application in osteoarthritis . In general, small molecules~     (SM) are low molecular weight compounds with biological functions that can influence~     molecular processes. They allow a symptomatic treatment, offering a short-term benefit for~     patients in terms of an amelioration of the phenotype. Although this kind of treatment does~     not correct genetic alterations, it can still be highly beneficial by damping down disease~     symptoms, thereby increasing life quality and minimizing secondary manifestations.~      It is important to emphasize that besides dressings, there are currently no other~     treatments, therefore, investigators do not prevent an accepted treatment for the patient~     and there is no risk for the participant. The treatment will be given only to the armpits~     although the disease can involve other areas, so stopping dressings in the armpits during~     the study does not risk the patient. Should there be any deterioration of the patient,~     whether it is related to the treatment with diacerein or not, investigators will stop the~     use of diacerein.~   "
44796|NCT02470676|"~     The purpose of this randomized control trial is to determine whether cervical pessary plus~     vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm~     delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic~     mid-pregnancy short cervix, in singleton and twin gestations.~      All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24~     completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed~     with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to~     participate in the clinical trial.~      Women who meet eligible criteria will be invited to participate in the clinical trial.~      Women will be randomly assigned into one of the following groups: group A (vaginal~     progesterone) or group B (vaginal progesterone + pessary).~      Follow-up visits for ultrasound assessment of fetal growth and cervical length will be~     carried out every two weeks until 37 weeks of gestation.~   "
44797|NCT02470663|"~     Patients diagnosed with, or in risk of osteoporosis regularly take calcium dietary~     supplements, although their contribution to BMD maintenance, prevention of bone loss or~     reduction of the risk of fracture is questionable. Freshwater crayfish rely on amorphous~     calcium carbonate (ACC), a thermodynamically instable and very rare biomineralized polymorph~     of calcium carbonate, as the main mineral in the exoskeleton and in their temporary storage~     organ, the gastrolith. The study hypothesis is that amorphous calcium carbonate (ACC) will~     have an advantage over calcium carbonate in improving BMD of pediatric IBD patients with~     reduced BMD. The investigators will include children 10-18 years old with IBD and reduced~     bone density to recieve regular calcium or amorphic calcium for 12 months with follow up of~     bone density and confounders as disease activity and medications.~   "
44798|NCT02470650|"~     The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks~     of initiation of antiretroviral treatment. three strategies of treatment.~   "
44815|NCT02470416|"~     Little is known about the prevalence of small bowel polyps in patients with sporadic~     Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small~     bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary~     adenomas by performing small bowel capsule endoscopy and comparing the results to those~     acquired from a control cohort undergoing VCE for accepted indication at our centre.~   "
44816|NCT02470403|"~     A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and~     normoglycemic patients with elevated body mass index (BMI)~   "
44799|NCT02470637|"~     Primary Objective:~      To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different~     single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous~     (SC) insulin lispro in a euglycemic clamp setting.~      Secondary Objectives:~      To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single~     doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in~     a euglycemic clamp setting.~      To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza~     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic~     clamp setting.~      To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza~     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic~     clamp setting.~      To assess the safety and tolerability of 3 different single doses of Afrezza inhaled~     Technosphere insulin.~   "
44800|NCT02470624|"~     This is a multi-center registry study. The investigators will include 10,000 patients with~     confirmed acute ischemic stroke in China. The aim of the study is to survey current~     treatment situation in China and compare the effectiveness and safety between different~     intervention regimens.~   "
44801|NCT02470611|"~     In the past few years, studies have evaluated the effect of systemic use of sodium~     alendronate, especially in the treatment of structural bone defects caused by periodontal~     diseases. This study evaluated the effects of non-surgical periodontal treatment associated~     with the topical application of 1% sodium alendronate on clinical and topographical~     parameters. Chronic periodontitis patients were recruited for the present study and were~     monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.~   "
44802|NCT02470598|"~     The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or~     improvement of the hydration status of more than 250 PD patients, and to observe the~     tolerability of the therapy over a long period.~   "
44803|NCT02470585|"~     The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib~     in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian,~     fallopian tube, or primary peritoneal cancer.~   "
44804|NCT02470572|"~     A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™~     Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases~     from all major organ systems. Pathologist will read and diagnose cases on a conventional~     light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized~     read order. College of American Pathologists (CAP) cancer protocol checklists will be used~     to capture diagnostic reporting.~      Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and~     compared directly to the Ground Truth (GT) diagnosis for both modalities.~   "
44805|NCT02470559|"~     This phase I trial studies the side effects and best dose of activated T-cell therapy when~     given together with low-dose aldesleukin and sargramostim in treating patients with ovarian,~     fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to~     previous treatment, or has come back. Activated T cells that have been coated with~     bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human~     epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways~     and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor~     cells. Colony-stimulating factors, such as sargramostim, may increase the production of~     blood cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may~     be a better treatment for ovarian, fallopian tube, or primary peritoneal cancer.~   "
44806|NCT02470546|"~     Primary aim:~      -To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in~     patients with liver cirrhosis.~      Secondary aim:~      -To evaluate if metformin is a safety drug in patients showing liver cirrhosis.~   "
44807|NCT02470533|"~     Rationale:~      This study will compare head to head in patients with hepatocellular carcinoma (HCC)~     ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial~     chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm,~     stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to~     progression is more favorable after SBRT than after TACE-DEB. The expected time to include~     the required patients for this trial will be four years.~      To the best of the investigators knowledge this study will be the first in the world that~     will compare both techniques in a randomized trial.~      Objective:~      To assess the time to progression after TACE-DEB and after SBRT in a comparable population~     of patients diagnosed with HCC.~      Study design:~      Randomized, prospective, open-label, and phase II study.~      Study population:~      Patients diagnosed with HCC, Child-Pugh grade A, one tumor (with at most 2 satellite~     lesions) ≤ 6cm, and ≥ 18 years old.~      Intervention:~      Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with~     doxorubicin or the experimental arm, SBRT.~      Main study parameters/endpoints:~      The primary endpoint of this study will be time to progression, defined as time from~     randomization to radiological progression.~      Secondary endpoints will be:~        -  Time to local recurrence~        -  Response rate (complete and partial response)~        -  Overall survival~        -  Toxicity~        -  Quality of life.~   "
44808|NCT02470520|"~     The aim of this study is to measure plasma levels of essential vitamins, trace elements and~     amino acids in critically ill patients with severe AKI. In patients who are treated with~     continuous renal replacement therapy, we plan to evaluate whether there are any additional~     losses of nutrients into the filtrate.~   "
44809|NCT02470507|"~     The immune response to kidney damage during acute kidney injury (AKI) is an important~     contributor to the prolonged lack of renal function and progression of kidney injury. Most~     data related to intrarenal and interorgan pathways in AKI stem from animal research with~     sometimes conflicting results. Accurate evaluation of these processes in humans and~     identification of early diagnostic tools are critical for the development of strategies to~     prevent and attenuate AKI-related morbidity and mortality in patients.~      The aim of this study is to evaluate immune function and miRNA expression in hospitalised~     patients with and without AKI.~   "
44810|NCT02470481|"~     The purpose of this study is to conduct full psychometric testing of the Early Arthritis for~     Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations~   "
44817|NCT02470390|"~     A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and~     bioavailability study in healthy volunteers.~   "
44818|NCT02470377|"~     The goal of this study is to determine whether external neuromodulation using repetitive~     transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is~     experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is~     translated as the sickness of disembarkment, and refers to the chronic feeling of rocking~     dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and~     morbidity is high. The goal of the study is to determine whether rTMS can suppress the~     rocking dizziness of MdDS and to determine whether imaging and electrical biomarkers can~     aide in more effective targeting. The investigators will make correlations between~     functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific~     clinical features to determine whether functional connectivity between particular hubs in~     the brain correlate with clinical improvement.~   "
44819|NCT02470364|"~     The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related~     quality of life scale for myasthenia gravis) for use with French-speaking patients in France~     and to evaluate its psychometric properties to ensure reliability and validity.~   "
44820|NCT02470351|"~     This study aims to describe in depth the CNS, CNS HIV reservoir and CNS viral rebound in~     consenting SEARCH 019 subjects prior to, during and after the SEARCH 019 study intervention~     (VHM + ART or ART only), at 1) baseline, 2) end of study intervention and start of ART~     interruption, 3) viral rebound (if occurring) or mid-way during observed ART interruption,~     and 4) at the end of ART interruption. Study SEARCH 026 itself does not employ any~     therapeutic interventions. However, consenting subjects will participate in lumbar puncture,~     non-contrast MRI + MRS, and neuropsychological testing at at least three and at most four~     time points. Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH~     026 participation and hence a maximum of 15 subjects may enroll. As this is a sub-study,~     data will be shared from study SEARCH 019 and no interventions (venipunctures) will be~     repeated unnecessarily.~   "
44821|NCT02470338|"~     This study is to show that the investigators believe the Modified Brostrӧm Procedure can be~     completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if determined not~     to be necessary in all cases, is a waste of resources in terms of operating room, surgeon,~     and staff time as well causing an increase in hospital financial expenses. Most importantly,~     this procedure is morbid. Ankle arthroscopy forces a patient's foot into distraction for up~     to one hour, exposes the patient to potentially longer anesthesia exposure that is~     unnecessary, increases infectious risks, and requires exposure at the portal sites near~     superficial nerves.~   "
44822|NCT02470325|"~     A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in~     children with neurological diseases. The clinical trial will include 40 children divided~     into two groups: children with spasticity and dystonia due to cerebral palsy, and children~     with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be~     randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to~     THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various~     variables will be collected including: medication intake, spasticity, dystonia score, pain~     scale, restlessness scale, quality of life measures, safety tests, side effects, and an~     addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia~     and spasticity in children with motor disability related to genetic neurodegenerative~     diseases and cerebral palsy and as a result improve motor function, non-motor functions and~     quality of life.~   "
44823|NCT02470312|"~     The goal of this registry/observational study is to collect data on the clinical utility of~     MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and~     electrophysiology (EP) procedures.~   "
44824|NCT02470299|"~     There is a move towards personalized medicine in cancer care, and significant effort is~     underway to evaluate new targeted therapeutics for the treatment of ovarian cancer. One way~     to identify potential new drug targets is by screening a drug library to determine whether~     drugs in the library target key kinase or enzymatic sites in cellular signaling pathways.~     Previous preclinical work and pilot studies demonstrated that ketorolac (a type of~     non-steroidal anti-inflammatory drug) inhibits GTPase activity in ovarian cancer cells~     retrieved from the post-operative peritoneal cavity.~      The purpose of this study is to confirm that this inhibitory effect is ketorolac driven and~     not a specific effect of the post-operative peritoneal compartment.~   "
44825|NCT02470286|"~     This study is a block-randomized, double-blind, placebo-controlled, single/multiple-dose,~     dose-escalation, Phase I clinical study to investigate the pharmacokinetics and~     safety/tolerability of SA001 in healthy male volunteer.~   "
44826|NCT02470273|"~     The purpose of this study is to calculate the sensitivity and specificity of a novel imaging~     device and associated software algorithm in detecting early stage melanoma versus nevi of~     the skin. The instrument, which was invented by the PI, for the purposes of this study, will~     be loaned to three external (to Rockefeller) institutions and used on patients who are~     scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening~     result of the novel device and the output diagnosis of the gold standard histology analysis~     procedure is so that these two diagnoses can be compared to generate the number of true~     positives, true negatives, false positives and false negatives for the novel device. The~     purpose of disseminating the device to the external institutions is to achieve the~     appropriate power such that the specificity can be evaluated at 99% sensitivity. The~     rationale for the power needed in the study is that in order to be clinically useful, the~     device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a~     dangerous situation, leading to potential progression of melanoma, the most deadly form of~     skin cancer.~   "
44842|NCT02470065|"~     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early~     stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and~     ARM B: immediate surgery with curative intent.~   "
44843|NCT02470052|"~     This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung~     function and safety after treatment with OL-BF-001 for severe emphysema.~      OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit.~     A bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the~     airways of one lung. It is used to redirect air from the less healthy to the more healthy~     parts of the lung. This helps to reduce over-inflation and may improve overall lung function~     and quality of life for people living with emphysema.~   "
44827|NCT02470260|"~     Pre-diabetes, type 2 diabetes, and their related conditions, adiposity and insulin~     resistance, are more prevalent in minorities Northern Manhattan compared to the general~     population of the United States. Despite knowledge of the main biologic determinants of~     these conditions (high caloric intake and sedentarism) the prevalence of these conditions~     continue to increase. In addition, these conditions can cause mental health problems~     including increased depressive symptoms and cognitive impairment. Thus, the investigators~     decided to conduct a community based study of middle aged Hispanic men and women aged 50 to~     64 years at baseline in order to:~        1. Document the prevalence and incidence, of pre-diabetes, diabetes, overweight, obesity,~          and associated conditions (e.g. dyslipidemia, hypertension).~        2. Study how social determinants of health (SDOH) affect these conditions.~        3. Study the consequences of these conditions on aging and mental health outcomes,~          including cognitive impairment.~   "
44828|NCT02470247|"~     Diagnostic imaging for vascular investigations and endovascular procedures frequently~     require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an~     acute kidney injury can appear: the contrast-induced nephropathy (NPCI).~      NPCI is associated with an increase of patients' morbidity and mortality. One of the~     conventional methods proposed to limit this NPCI is an oral administration of~     N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours~     after the injection. However, in some patients this method cannot be performed due to a high~     risk of heart failure although they are generally at high risk of NPCI.~      Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning~     (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated~     with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as~     compared with NAC and hydration only. .~      We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive~     NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter~     Aortic Valve Implantation (TAVI)) could be promising.~   "
44829|NCT02470234|"~     To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate~     hydrochloride extended-release) capsules under fed conditions in male or female children 4~     to under 6 years of age with ADHD.~   "
44830|NCT02470221|"~     This study is aim to assess the effect of goal-directed intraoperative fluid therapy on~     patient's postoperative incidence rates of complications, length of hospitalization and~     hospitalization cost.~      This is an observational study followed cohort study design, due to the two therapies were~     not randomized assigned to the two cohorts. The details are described as follow.~   "
44831|NCT02470208|"~     The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine~     immune competence against CMV infection in stem cell transplantation.~      To determine the utility of the T-SPOT.CMV assay used before transplantation to determine~     immune competence against subsequent CMV reactivation and to determine the utility of the~     T-SPOT.CMV assay used after transplantation to determine immune competence against~     subsequent CMV reactivation.~   "
44832|NCT02470195|"~     Difficult airway management is a crucial point that may influence outcomes of patient in~     this critical situation. Education for this topic is of main importance for resident of~     anesthesiology. Procedural simulation workshop allows participant to use device dedicated to~     difficult airway management. Investigators included this workshop to a state education~     program of anesthesiology resident in second year and compared to their homonym in another~     state where no specific organized workshop is integrated to the education program.~   "
44833|NCT02470182|"~     The purpose of this study is to learn more about breathing disorders during sleep. The~     investigators want to learn how breathing sounds made during sleep relate to breathing~     disorders during sleep.~   "
44834|NCT02470169|"~     Four hundred and fifty women with endometriosis will be divided into 3 equal groups using~     computer generated random numbers: Group 1 will have up to 4 stimulated intrauterine~     insemination (IUI) cycles, group 2 will have up to 4 unstimulated cycles, women who do not~     become pregnant after the 4 cycles in groups 1 and 2 will be advised to have regular~     intercourse at the expected time of ovulation. Group 3 will be the control group will be~     advised to have regular sexual intercourse at the time of ovulation for 4 months~   "
44835|NCT02470156|"~     This 12-month randomized trial is designed to evaluate the impact of low intensity~     (quarterly) versus high intensity (monthly) wellness coaching programs on women's success~     achieving individual health goals related to active living and healthy eating and changes in~     these health behaviors over time.~   "
44836|NCT02470143|"~     The pilot study will investigate the usability of a mobile cycling application in a cardiac~     patient population during a one month study period.~      The application's effectiveness regarding ability to reduce fear and increase motivation to~     exercise will be assessed.~   "
44837|NCT02470130|"~     Resident in advanced medical training participated to high fidelity simulation education~     program in Lyon. Alternatively 1 or 2 resident act during a scenario while the others~     observe in a teletransmission closeby room. Debriefing follows the critical scenario in~     witch resident are involved. The investigators are testing the effects of five minute of~     conversational relaxation before the debriefing on the anxiety level and memorization of key~     points each scénario on participant and observer.~   "
44838|NCT02470117|"~     This study evaluates the efficacy of alginate-based reflux suppressant and~     magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the~     participants will receive alginate-based reflux suppressant, while the other half will~     receive magnesium-aluminium antacid gel.~   "
44839|NCT02470104|"~     The investigators hypothesize that children receiving human milk will maintain a greater~     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in~     the blood compared with children not receiving human milk.~   "
44840|NCT02470091|"~     This phase II trial studies how well denosumab works in treating patients with osteosarcoma~     that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal~     antibodies, such as denosumab, may block tumor growth in different ways by targeting certain~     cells.~   "
44841|NCT02470078|"~     The purpose of this study is to evaluate whether pharyngeal electrical stimulation in~     addition to standard care can enhance swallowing recovery in severely dysphagic stroke~     patients post extubation compared to sham treatment plus standard care.~   "
44844|NCT02470039|"~     This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338~     (insulin-338) in a tablet formulation and insulin glargine in combination with metformin~     with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral~     antidiabetic therapy.~   "
44845|NCT02470026|"~     This study investigates influences of nordadrenergic activity on cognition in patients with~     major depression regarding influences of early life stress.~   "
44846|NCT02470013|"~     The aim of this study is to assess the benefit of a 3-month intervention with oral~     nutritional supplements (ONS) in older ambulant patients with reference to functional~     limitations and quality of life as well as the consumption of health care resources.~   "
44847|NCT02470000|"~     Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP)~     in taut bands within the affected muscles. Chronic MPS over neck is prevalent and~     responsible for markedly loss of work-day and a reduction of quality of life.~      Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood~     by low-level laser light through an optical fiber inserted in a vein. Researches disclosed~     that ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen~     saturation in blood. However, no research studies the effectiveness of ILIB to treat MPS.~      Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the~     stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the~     relative stiffness of structures. For a given material, faster SWV indicates the greater~     stiffness. To our knowledge, only one research using RTS and SWV to study MPS.~      To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of~     RTS and SWV for MPS, we conducted this study.~   "
44848|NCT02469987|"~     Double-blind, single-dose, three-treatment, parallel group design PK comparability study of~     MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution~     (bevacizumab).~   "
44849|NCT02469974|"~     To determine the safety of the approach of giving RUXOLITINIB before and after an autologous~     stem cell transplant, as measured by graft failure or death.~   "
44850|NCT02469961|"~     The standard hospital procedure calls for the patient to undergo Interscalene block under~     ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).~     The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the~     patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The~     participant is then brought to the OR and prolonged sedation is initiated, randomly using~     either Dexmedetomidine or Propofol.~      The primary objective of the present study is to use Dexmedetomidine for sedation, and~     compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for~     this study.~      Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and~     reduced need for supplemental medication for sedation, compared to Propofol~   "
44851|NCT02469948|"~     Stroke may result in lower extremity spasticity, which interfere with motor voluntary~     function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to~     improve lower extremity spasticity of stroke patients. There are no researches to compare~     the efficiency of BTX-A injection by different guidance methods in the deep muscles of lower~     extremity for stroke patients. The aims of investigator's study were to compare the~     effectiveness of BTX-A injection by different guidance methods (palpation of anatomical~     landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke~     patients with varus spasticity and spastic claw toes , and to study the correlation between~     muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force~     impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A~     injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw~     toes and duration more than 6 months. Under different guidance methods (palpation of~     anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods),~     BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the~     patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected.~     The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth~     Scale, Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain,~     Stroke Impact Scale, Barthel index and lower extremity function tests, balance test, Goal~     Attainment Scale, sonoelastography and acoustic radiation force impulse imaging. All the~     assessments will be performed before BTX-A injection and followed up at 1 months, 2 months,~     3 months and 6 months after injection. After performing all the assessments, investigator~     will investigate the efficiency of BTX-A by different guidance methods.~   "
44852|NCT02469935|"~     Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the~     detection of gallstones.~      Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound~     examination, were examined with a right upper quadrant ultrasound scan by a radiologist as~     well as surgeon. The surgeons had undergone a four-week long education in ultrasound before~     participating in the study. Ultrasound findings of the surgeon were compared to those of the~     radiologist, using radiologist-performed ultrasound as reference standard.~   "
44853|NCT02469922|"~     Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during~     radio-chemotherapy, on the loco-regional control after 2 years~   "
44854|NCT02469909|"~     The investigators propose to examine the feasibility and safety of immediate (single stage)~     decannulation in adult patients in a controlled randomized trial. Patients who will be found~     fit for decannulation after an otolaryngologist and intensive care specialist assessment~     will be randomized into two groups: immediate decannulation and gradual decrease in cannula~     size. Both groups of patients will be monitored after decannulation and in the outpatient~     clinic for any complications following the procedure.~   "
44855|NCT02469896|"~     This research study is being done to find out if tocilizumab, also known as Actemra™, can~     help with Amyotrophic Lateral Sclerosis (ALS). The investigators also want to find out if~     tocilizumab is safe to take without causing too many side effects.~      Currently ALS has no cure and only 1 modestly effective treatment to slow the progression of~     the disease. Although not the initial cause of ALS, the immune system plays a role in the~     death of motor neurons. The immune cells that participate in this process are stimulated by~     a substance called interleukin-6 (IL-6) whose effect is blocked by tocilizumab and thus, may~     slow the death of motor neurons and slow the disease.~   "
44856|NCT02469883|"~     This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting~     toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity~     of Sinotecean.~   "
44857|NCT02469870|"~     The evaluation of the program efficacy will be conducted via a randomized control study with~     136 parents of children aged 3-8 who have autism. Investigators will test whether, compared~     to a content comparison group (CC), administration of the APT program over a 3-week~     intervention period (a) improves child behaviors, (b) increases perceived quality of life,~     (c) decreases parental stress, (d) increases positive parenting practices, and (e) increases~     parent knowledge of evidence-based support practices.~   "
44859|NCT02469844|"~     Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people~     in England suffer from epilepsy. About 40% of these patients are known to have seizures~     predominantly in sleep. All seizures pose risk to the individual both physical and~     psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed.~     Patients with nocturnal seizures are also thought to be at particular risk of sudden~     unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In~     patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per~     1,000 patient years. Previous studies show that many seizures are associated with changes in~     the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate~     variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede~     the onset of epileptic seizure related surface electroencephalographic (EEG) changes,~     suggesting that ANS tone changes could be used in seizure alarm or intervention systems.~     This prospective study intends to focus on seizures from sleep and study HRV parameters in~     the immediate preictal state of the seizure and compare these with resting HRV parameters in~     the same patient with the aim of finding HRV metrics which could help to identify the~     presence of seizures in longterm electrocardiographic (ECG) recordings, or help predict~     seizure occurrence, or provide information about the current risk of seizures. This study~     will also investigate whether there are differences in the alterations of HRV parameters~     between different forms of epilepsy and whether seizure lateralisation has an impact on HRV~     parameters.~   "
44860|NCT02469831|"~     The investigators aim to investigate the differences between deep continuous muscle~     relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy~     in respect to metabolic changes and respiratory mechanics.~   "
44861|NCT02469818|"~     Shoulder dislocation is a common clinical presentation in the emergency department,~     comprising about 50 percent of all major joint dislocations. In the standart management of~     shoulder dislocations physicians generally need to see pre and post reduction x ray~     graphics. Ultrasonography is harmless way of evaluating shoulder and may be used in the~     management of the shoulder dislocations instead of the x ray evaluations.~   "
44862|NCT02469805|"~     Four hundred and fifty women with mild male factor infertility will be divided into 3 equal~     groups using computer generated random numbers: Group 1 will have up to 4 stimulated IUI~     cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant~     after the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the~     expected time of ovulation. Group 3 will be the control group will be advised to have~     regular sexual intercourse at the time of ovulation for 6 months~   "
44863|NCT02469792|"~     Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution~     800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the~     patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by~     one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This~     is a single arm study with no control. All patients receive cell therapy.~   "
44864|NCT02469779|"~     The goal of this research study is to learn how middle and high school students react to an~     interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health~     information online and what their preferences are when using ASPIRE.~      Researchers hope to use the results of this study to design more effective online health~     programs to provide middle and high school students with up-to-date information about~     tobacco use, meditation, and general health and well-being.~   "
44865|NCT02469766|"~     This study will be conducted to compare the success and complication rates of ureteroscopy,~     and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.~   "
44866|NCT02469753|"~     Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that~     affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in~     most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for~     AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in~     controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and~     psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the~     structural progression of AS, some data even suggesting that it may accelerate the formation~     of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit~     ossification phenomena independently of their anti-inflammatory properties, owing to a~     specific action on bone formation via prostaglandin inhibition.~      Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF~     treatment, to prevent syndesmophyte formation in AS patients.~   "
44867|NCT02469740|"~     Usage of antiplatelet agents and cardiac procedures such as coronary angioplasty has~     dramatically improved the morbidity and mortality associated with coronary artery disease.~     In patients with a coronary stent, dual antiplatelet therapy is recommended. Aspirin is the~     main antiplatelet agent used. For many years, clopidogrel was the second antiplatelet of~     choice. Recent studies have revealed new antiplatelet drugs that can substitute clopidogrel,~     one of which is ticagrelor. The degree to which ticagrelor reduced the overall mortality~     compared to clopidogrel in the PLATO trial suggested that ticagrelor possibly has a~     pleiotropic effect and that the reduction in mortality is not simply due to its antiplatelet~     effects. The ticagrelor molecule resembles adenosine. Adenosine has been shown to be~     cardioprotective.~      The aim of this project is to study the effects of ticagrelor on the arterial system using a~     noninvasive method. The study will employ the measurement of peripheral endothelial function~     of patients who undergo percutaneous coronary intervention who are on ticagrelor vs.~     clopidogrel using a cross over trial design.~   "
44868|NCT02469727|"~     The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit~     Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit~     mHealth app. The target population will be childhood cancer survivors 14-18 years old~     recruited from Seattle Children's Hospital. For the intervention group, peer influences will~     be engaged via a private, social network (e.g. a Facebook group) customized for survivors.~     Measurements will be completed (1) at baseline, prior to randomization, and (2) during the~     final week of the intervention period (follow-up measure). This study will provide initial~     proof of concept and allow for further customization of the intervention for childhood~     cancer survivors in anticipation of a future, larger proposal to study physical activity and~     related outcomes over a multi-year period.~   "
44869|NCT02469714|"~     The health care needs of people with serious mental illness are exacerbated by ethnic health~     disparities. Latinos with serious mental illness show significant health problems compared~     to other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator~     program for Latinos with serious mental illness using community-based participatory research~     (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental~     illness that have formed a Consumer Research Team (CRT) that will guide this project. This~     project will identify and define the problem by conducting a mixed methods research thru~     qualitative interviews with various stakeholders defined by the investigator's CRT group.~     The qualitative findings will then be cross-validated in a quantitative survey by 100~     Hispanic/Latinos with mental illness. This information will then be used to design an~     intervention using an integrated care model for Peer-Navigators. Feasibility, accessibility~     , acceptability and impact of the peer-navigator program will be then evaluated in a~     randomized control trial (RCT) with 100 Latinos with serious mental illness who will~     complete measures of physical health, mental health, service use and engagement at baseline,~     4, 8, and 12 months. Investigators expect to show physical health improvement with the~     greater engagement observed in the peer navigator group. Investigators expect a similar~     improvement in mental health and quality of life as physical health concerns are diminished.~   "
44870|NCT02469701|"~     Nivolumab releases the inhibition of the immune system against human cancers. Dramatic and~     sustained activity has been observed in advanced lung cancer. Ablation may stimulate the~     immune system by exposing new tumor antigens. Since tumors that express PD-L1 may be more~     likely to respond to nivolumab, if ablation increases PD-L1 expression (which has not been~     studied) this treatment may enhance the activity of nivolumab at both the treated site and~     in other, non-treated, tumors. Ablation is already an FDA approved treatment for cancer.~     Nivolumab was recently FDA approved for second line treatment of advanced squamous cell~     NSCLC. The goal of the study will be to determine if the combination of nivolumab and~     ablation has higher systemic activity than previously reported with nivolumab alone.~   "
44871|NCT02469688|"~     Examine safety and immunological response for ASP4070 when vaccinated in patients with~     pollen allergy~   "
44872|NCT02469675|"~     Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral~     sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may~     be an important method to improve functional recovery.~      In this study, the investigators aim to use non-invasive magnetic and electrical stimulation~     to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used~     over the motor cortex (scalp). Two methods of electrical stimulation will be compared:~     stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal~     cord across the skin on the back of the neck. Several different combinations of magnetic and~     electrical stimulation will be compared to find the conditions that best strengthen nerve~     circuits between the brain and hands - Fire Together, Wire Together.~      PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in~     nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS~     STUDY. If we see temporary changes in this study, then future studies would focus on how to~     prolong that effect.~   "
44873|NCT02469662|"~     The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total~     Elbow when used in primary or revision total elbow replacement.~   "
44874|NCT02469610|"~     It is well known that chest surgery patients suffer from high level pain in the~     perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The~     proper pain control technique for thoracoscopic approaches is still under debate. One of the~     most popular methods for pain control is these procedures is the Intercostal block. The~     Intercostal block is usually based upon topical analgesic. In this study the investigators~     will try to examine the effect on pain control of the timing of Intercostal block of 100 mg~     BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into~     two groups. In the control group patients will have Intercostal block after surgery and in~     the study group the intercostal block will be given in the beginning of the surgical~     procedure. All other analgesic treatment during and post-surgery will be the same in both~     groups. The study will evaluate pain level in the days after the surgery, analgesic~     medication consumption and relevant morbidity.~   "
44875|NCT02469597|"~     The purpose of this study is to assess if administration of an early single dose of a~     diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce~     extravascular lung water in an effort to reduce respiratory rate, retractions, intubations,~     and length of stay.~   "
44876|NCT02469584|"~     A descent of the anterior vaginal wall is the most common form of female pelvic organ~     prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a standard~     procedure, its exact steps are not well standardized.~      We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the~     strength and durability of AC~      Objectives~      The aim of this pilot study is to demonstrate the feasibility and complication rate of the~     SSTAC and to assess the anatomical and functional outcomes after this method of cystocele~     repair.~   "
44877|NCT02469571|"~     Background Sepsis is a common disease leading to high morbidity and mortality. Gut~     microbiota and/or gut permeability may play a crucial role in the development of organ~     dysfunction.~      Hypothesis The ingestion of a multispecies probiotic in early sepsis is able to modulate gut~     microbiota and/or gut permeability.~   "
44878|NCT02469558|"~     Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and~     mortality. Probiotic modulation of gut flora is a possible therapeutic mechanism.~      The aim of this study is to investigate and compare thoroughly the effect of a multispecies~     probiotic on glycaemic control, gut microbiota and gut permeability in patients with~     metabolic syndrome and diabetes.~   "
44879|NCT02469545|"~     The aim of the study is to determine the influence of supplementation of probiotic~     Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with~     SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.~   "
44880|NCT02469532|"~     This is a prospective, multi-center, observational registry to document the baseline,~     24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up~     after femoropopliteal angioplasty or atherectomy-based revascularization procedures.~   "
44882|NCT02469506|"~     Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged~     period of immobilization in otherwise healthy individuals. Long-term immobilization of the~     lower extremity has shown to cause significant reductions in skeletal muscle mass, already~     occurring during the early stages of disuse. Accordingly, feasible strategies for~     attenuating this loss of muscle during disuse need to be pursued. Local neuromuscular~     electrical stimulation (NMES) offers such a potential strategy but, as yet, remains untested~     during prolonged muscle disuse in a clinical setting.~      Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates~     muscle loss during 2 weeks of unilateral ankle immobilization.~      Study design: Randomized, parallel (two groups) study design.~      Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing~     surgical treatment.~      Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.~      Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area~     (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content,~     intramuscular triglyceride content and mRNA and protein expression of anabolic signaling~     proteins.~   "
44883|NCT02469493|"~     The purpose of this study is to compare the preventive effect of electroacupuncture and sham~     acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its~     potential mechanism by using functional Magnetic Resonance Imaging (fMRI).~   "
44884|NCT02469480|"~     Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%.~     About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both~     physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic~     disease like cancer often results in a reduced availability of iron for the body. In~     clinical practice iron substitution is usually administered orally. Due to low resorption~     rates, frequent gastric side effects and thus poor patient compliance a parenteral~     substitution seems to be a better option in terms of efficacy. In the framework of a~     randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of~     parenteral vs. oral iron substitution will now be conducted in order to identify the best~     treatment form for clinical practice in oncology. Furthermore detailed quality of life-data~     (QoL) will be collected in both treatment arms for effect comparison.~   "
44885|NCT02469467|"~     The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with~     meal for 8 weeks to hemodialysis patients with hyperphosphatemia~   "
44886|NCT02469454|"~     This study aims to assess whether there is change in the growth and development of newborns~     whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to~     48 hours of delivery compared with those with standard implant insertion (6 week~     postpartum).~   "
44887|NCT02469441|"~     The aim of the study is to investigate if postoperative coffee intake decreases the time~     until first bowel movement in elective colorectal surgery with primary anastomosis.~   "
44888|NCT02469428|"~     The purpose of this protocol is to assess whether epigenetic factors in healthy individuals~     make a person more or less responsive to lung inflammation following ozone exposures.~   "
44889|NCT02469415|"~     The goal of this clinical research study is to learn if pacritinib, either alone or in~     combination with azacitidine or decitabine, can help to control MDS.~      The safety of this drug and drug combination will also be studied.~   "
44890|NCT02469402|"~     Formula contains significantly higher total protein concentrations than breast milk.~     Therefore formula-fed infants have a significantly higher total protein intake in the first~     few months compared to exclusively breast-fed infants.~      The aim is to examine the nutritive efficacy and safety of a modified infant formula with a~     reduced protein content and improved protein quality in a prospective, double-blind,~     controled, randomized study. Primary outcome measures are weight gain and growth of young~     infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the~     qualitative and quantitative changes in the protein content of the new formula will be~     recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group~     will be fed for 3 months with an infant formula with decreased protein content. At the same~     time the protein body of the new formula is modified by enrichment with bovine~     alpha-lactalbumin.~      A control group receives a isocaloric conventional infant formula and a protein body~     consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of~     alpha-lactalbumin over the same time-period.~      A group of breastmilk fed infants will serve as a reference group. In regular anthropometric~     controls growth and thriving of the study participants is documented and compared between~     the different groups.~   "
44891|NCT02469389|"~     The goal of this project is to evaluate an innovative psychosocial intervention package that~     will incorporate evidence-based treatment strategies to target the affective-motivational~     deficits, negative expectancies, and behavioral skills deficits that are central to the~     maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community~     Roles and Experiences) - will include strategies aimed at teaching Veterans with~     schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure,~     (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for~     failure, and (4) perform skillfully in new social situations, all of which can impact~     implementation of new skills and behaviors. Rather than develop a new set of intervention~     strategies, the investigators will include within EnCoRE evidence-based strategies for these~     treatment domains. In addition, the investigators will collect qualitative information both~     from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to~     participation in EnCoRE, as well as from a sample of mental health providers who work with~     Veterans with schizophrenia and negative symptoms, in order to inform a larger scale~     implementation trial should EnCoRE prove effective here.~   "
44915|NCT02469077|"~     Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a~     change associated with increased opioid abuse (via greater exposure in vulnerable~     individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in~     opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic~     high-dose opioids are sorely needed. This project will test the novel hypothesis that~     effective pain relief can be achieved at lower opioid analgesic doses by increasing levels~     of endogenous opioids (EOs).~   "
44892|NCT02469376|"~     Arterial and venous thrombi play an important role in various vascular diseases such as~     myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism.~     These thromboembolic disorders are the leading causes of morbidity and mortality worldwide.~     A non-invasive method for the quantitative and effective detection of thrombi in the whole~     body has not yet been established. In spite of the available techniques, 30% to 40% of~     ischemic strokes cryptogenic (undetermined cause, the source of thromboembolism is never~     identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic~     arch or intracranial arteries. A plaque in the arch or other large vessels could be an~     important source of cryptogenic strokes, however, are those difficult to detect by routine~     methods. The approach of thrombus targeted molecular imaging could identify potentially~     troublesome plaques early on before they become a dangerous rupture. The hypothesis is that~     the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET)~     can be made visible. The primary goal is the potential applicability of the substance as a~     PET tracer for diagnosing thrombi.~   "
44893|NCT02469363|"~     During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads~     to an increase in the plasma catecholamine concentrations due to the activation of the~     sympatho-adrenal system. Prevention or reduction of this increment is important for~     hemodynamic control. Therefore, various methods such as providing adequate depth of~     anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative~     laryngoscopy devices and techniques have recently started to be used.~      In this randomized single blind study, the aim is to compare the hemodynamic responses of~     four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope,~     C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive~     airway.~   "
44894|NCT02469350|"~     In this study the investigators aim to assess the feasibility and acceptability of a serious~     game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease~     previously operated for deep brain stimulation of the sub thalamic nucleus.~   "
44895|NCT02469337|"~     The aim of the study is to investigate whether preoperative interventions such as~     carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in~     molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle~     insulin resistance in patients undergoing major abdominal surgery.~   "
44896|NCT02469324|"~     The current study is a two condition randomized controlled trial for women who are pregnant,~     interested in becoming pregnant, or pregnant within the last year. The conditions include a~     brief Cognitive Behavioral Therapy and a brief Compassionate Mind Training intervention.~     Participants in each condition will complete a 45 minute didactic exercises and readings~     followed by an email with exercises to continue practicing for a total of 2 weeks. After 2~     weeks, participants will receive post-baseline assessment measures (e.g., depression,~     anxiety, affect, self-reassurance, self-attacking, self-criticizing, self-compassion).~     Participants will be recruited through a women's clinic in the United Kingdom by Michelle~     Cree, M.S. and through listservs by Yotam Heineberg, Psy.D. The researchers will also invite~     individuals in their social networks through email and through the Amazon Mechanical Turk~     System.~   "
44897|NCT02469311|"~     Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a~     standard-of-care group who only had a bath with antibacterial soap and water. Both groups~     received standard infection control practices during admission.~   "
44898|NCT02469298|"~     Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm~     outpatient study evaluating the safety, tolerability and clinical effect of danirixin or~     danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for~     5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin~     is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits~     neutrophil transmigration and activation to areas of inflammation. The study endpoints are~     intended to test the hypothesis that inhibition of neutrophil activation by approximately~     50-60% (as previously measured by cluster of differentiation [CD11b] expression in response~     to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not~     impact safety parameters or worsen clinical manifestations of disease, disease-related~     events of interest, or viral load, and may possibly improve these parameters when~     administered within 48 hours of symptom onset. The aim of this exploratory study is to~     obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX])~     alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute,~     uncomplicated influenza prior to future evaluation in hospitalized patients with complicated~     influenza. The primary objective is to assess safety and tolerability of DNX with and~     without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory~     tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also~     include an assessment of disease related events (DREs) of interest and associated antibiotic~     use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to~     document patient reported outcomes (PROs). The screening visit in Australia will be composed~     of a pre-screen for influenza infection with an influenza rapid antigen test followed by a~     screen for the remaining eligibility criteria for those subjects with a positive result on~     the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health~     Private Limited.~   "
44899|NCT02469285|"~     High consumption of red meat is related to cardiovascular diseases. Red meat containing more~     unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty~     acid profile in humans. Furthermore, consumption of red meat and especially processed red~     meat is considered harmful to colon health. However, consumption of fruit and berries rich~     in antioxidants and flavonoids may provide protection when red meat is consumed.~      The study aims to answer whether the fatty acid profile of pork when modified towards more~     unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects~     of pork with a modified fatty acid content is compared with conventional pork with lower~     unsaturated fat content. Fatty acid composition of pork is modified by altering the~     composition of animal feed.~      The other arm of the study investigates the effects of consuming berries together with red~     meat on gut metabolism. The study focuses on how berries affect the formation of fecal~     compounds known to be related to high red meat consumption, such as N-nitroso compounds.~   "
44900|NCT02469272|"~     Nonalcoholic steatohepatitis (NASH) is common, may progress to cirrhosis and is predicted to~     become a leading indication for liver transplantation in the near future. Though often~     associated with obesity and the metabolic syndrome, our current understanding of disease~     development is limited and there are few therapeutic options. Imbalance of gut bacteria is~     suspected to play a key role driving the progression of fatty liver disease and there is~     hope manipulation of these bacteria may be beneficial. This study will determine if fecal~     microbiota transplantation, using stool from lean donors, is an effective and safe treatment~     for NASH.~   "
44935|NCT02468817|"~     Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss~     stimulates bone resorption via an increase in Parathyroid Hormone (PTH).~   "
44901|NCT02469259|"~     This study will investigate the effects of oxytocin on alcohol-related behaviors, social~     abilities, and physiological startle responses in healthy individuals and patients with~     posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized,~     placebo-controlled, dose-tiered, between-subject study design. Specifically, the~     investigators will determine if intranasal administration of a single dose of the pro-social~     neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social~     abilities, and decreases physiological hyperactivity. The investigators will also determine~     the optimal dose to achieve these effects and will explore psychosocial predictors of~     responses to oxytocin. The proposed work has the potential to yield a novel pharmacological~     treatment for AUD and PTSD, both leading causes of disability in the US Military for which~     currently available treatments are inadequate.~   "
44902|NCT02469246|"~     This study will evaluate the efficacy, safety, and tolerability of switching~     abacavir/lamivudine (ABC/3TC) to emtricitabine/tenofovir alafenamide (F/TAF) versus~     maintaining ABC/3TC in HIV-1 infected adults who are virologically suppressed on regimens~     containing ABC/3TC.~   "
44903|NCT02469233|"~     Mental illness is often severe, chronic and difficult to treat. The sleep disturbance~     commonly experienced by individuals with a severe mental illness reduces capacity to~     function and contributes to key symptoms. This study seeks to determine if an intervention~     to improve sleep can improve functioning and reduce symptoms and impairment. We will conduct~     this study in community mental health centers to ensure that the results contribute to~     closing the worrisome gap between research and practice and to ensure that the findings are~     generalizable to the real world.~   "
44904|NCT02469220|"~     The main objectives of this trial are to examine the effect of a low FODMAP diet on gut~     microbiota, inflammatory markers, gastrointestinal symptoms and quality of life in patients~     with ulcerative colitis. Furthermore the trial will explore if the response towards a low~     FODMAP diet can be predicted by a patients initial gut microbiota profile. The patients will~     be randomized to an open parallel-group intervention of six weeks duration with intake of~     either a low FODMAP diet or a control diet (habitual diet).~   "
44905|NCT02469207|"~     This study aims to use tissue from deceased organ donors to investigate organ physiology,~     developmental biology, as well as the development of future regenerative cellular therapies.~     It will investigate function and immune response to stem cells as well as their generation~     from adult cells and generation of induced pluripotent stem cells (iPSCs).~   "
44906|NCT02469194|"~     In general, the toxicity of radiation therapy and chemotherapy exhibits a strong~     dose-response relationship. However, patients receiving similar doses still exhibit a range~     of toxicity responses due to a variety of factors, including comorbid conditions, disease~     (cancer) specific factors, and inter-individual genetic variation. A very small percentage~     of patients experience side effects that are either extremely severe or extremely mild~     compared to the majority of patients for the dose of radiation or chemotherapy given.~     Currently, the reasons for this are not entirely clear, but likely relate to patient~     specific factors such as immune response, cell/tissue repair capacity and other factors that~     fundamentally rely on rare genetic variations at loci involved in these responses. For~     example, patients with homozygous deletions in DNA damage response genes such as ATM are~     uniquely sensitive to DNA damaging agents. Many patients with severe, homozygous mutations~     in such genes have other sequela that lead to medical recognition of the syndrome prior to~     therapy. The investigators hypothesize that patients with unusually severe toxicity from~     therapy that do not exhibit classical signs of homozygous mutation syndromes are~     heterozygous for nonfunctional or hypofunctional alleles at these loci, such that the defect~     is only uncovered under the relatively acute, severe stress on that pathway by radiation or~     chemotherapy. Conversely, patients with very mild reactions could exhibit rare~     variants/combinations of variants that make them uniquely resistant to chemotherapy or~     radiotherapy toxicity.~      The purpose of the study is to better understand these mechanisms with the eventual goal of~     developing predictive markers that will allow us to help individually tailor cancer therapy~     is in future patients. Will accomplish these goals by studying a variety of factors from a~     single vial of blood. These will include circulating proteins and hormones, circulating~     cells and the levels and sequences of white blood cell DNA or RNA using a variety of~     techniques including but not limited to determination of cytokine/hormone levels, proteomic~     analysis, immunocytochemical assays, whole exome sequencing and qPCR.~   "
44907|NCT02469181|"~     The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow~     in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex~     flow and CMR.~   "
44908|NCT02469168|"~     The purpose of this investigation is to evaluate the safety, tolerability, preliminary and~     long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell)~     combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate~     INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.~   "
44909|NCT02469155|"~     The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind,~     parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed~     with schizophrenia having an acute exacerbation of psychosis.~   "
44910|NCT02469142|"~     Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often~     prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia~     reparation, the recurrence rate were as high as 30%. In recent years, biological materials~     especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the~     infection, has become a research hotspot. In the project, the investigators try to address~     the role of ADM in incarcerated inguinal hernia patients.~   "
44911|NCT02469129|"~     The purpose of this research study is to determine the feasibility of using positron~     emission tomography (PET) imaging technology to image cancer with [18F]FluorThanatrace~     ([18F]FTT), a new radioactive tracer compound that has been developed that images~     poly(ADP-ribose) polymerase 1 (PARP-1) activity.~   "
44912|NCT02469116|"~     In this study the investigators will be using an AUC of 6 based on creatinine clearance~     using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.~      Given that myelosuppression was significant using the docetaxel dose of 75 mg/m*2 in the~     SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted.~     The expectation would be that patients will be able to receive their cycles in a more timely~     fashion, with less delays, thereby allowing for improved outcomes and decreased~     hospitalizations due to myelosuppression.~   "
44913|NCT02469103|"~     The purpose of this study is to investigate the accuracy of second generation colon capsule~     (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using~     conventional endoscopy as the gold standard.~   "
44914|NCT02469090|"~     A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3~     study in L-Dopa responsive PD patients with motor fluctuations (OFF episodes), designed to~     determine the efficacy, safety and tolerability of APL-130277.~   "
44916|NCT02469064|"~     Respiratory muscle training (RMT) is considered a therapeutic strategy to improve~     respiratory muscle strength in mechanically ventilated (MV) patients and facilitates~     ventilator weaning. RMT aims at improving strength and endurance of respiratory muscles .~     However, scarce research exists regarding evaluation of RMT in MV patients and additionally~     studies differ in methods, RMT protocols and subjects included. There are not reports about~     Colombian studies evaluating RMT effects on MV patients. The aim of this study is to~     evaluate the effectiveness of respiratory muscle training in increasing respiratory muscle~     strength and improving weaning outcomes in MV patients who required ventilatory support for~     more than 48 hours at an Intensive Care Unit of an IV level Hospital in Cali during the~     period 2014-2015~   "
44917|NCT02469051|"~     This study aims at combining inspiration breath-hold myocardial perfusion SPECT with~     coronary CT angiography.~   "
44918|NCT02469038|"~     While peripheral venous cannulation is among the most common procedures performed in~     clinical settings, it is estimated that PIV insertion fails for 6 million patients annually.~     Failure to establish peripheral venous access in the emergency department is a costly~     problem, leading to delays in diagnostics and treatment and requiring alternative sites for~     vascular access. These alternative methods can lead to higher complications rates, decreased~     patient satisfaction, and increased utilization of nursing and physician time. Complications~     from PIV failure also pose a significant financial burden to the healthcare system.~      Ultrasound guidance has been shown to greatly improve the process of localizing vessels for~     cannulation. In a healthcare climate that is increasingly focused on outcomes and~     cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a~     viable but often the preferred method in patients with difficult venous access.~     Nevertheless, studies to date on ultrasound-guided peripheral venous cannulation have~     revealed some shortcomings, such as premature failure and low first attempt success rates.~      The purpose of our study is to assess whether ultrasound-guided cannulation of a AccuCath~     catheter, which has a coiled tip guidewire, is superior to ultrasound-guided cannulation of~     a conventional peripheral IV catheter across clinical outcomes relevant to the emergency~     department setting.~   "
44919|NCT02469025|"~     Lower limb osteoarthritis is a major health problem in the westernized countries. The~     current gold standard treatment is joint replacement. However clinical guidelines recommend~     physical therapy as first option for these patients. Manual therapy has reported good~     reports in function, range of motion and pain in patients with hip osteoarthritis. The main~     aim of this study is to test the effects of a manual therapy protocol based on manual~     traction mobilization of the hip joint in an end range position and compare them with the~     effects achieve with the same protocol based on manual traction mobilization of the hip~     joint in a resting position. The investigators will use the caudal traction mobilization~     described by Kaltenborn. The study will test the effects of both treatments in passive range~     of motion, function and pain after three weeks of treatment, three weeks after finalizing~     the treatment and six weeks after.~   "
44920|NCT02469012|"~     The present study evaluates neurocognitive performance as well as measures of mood, quality~     of life, and fatigue in patients with chronic hepatitis C infection. In a prospective~     longitudinal study design, included patients are monitored before, during, and in the~     long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/-~     Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post~     therapy results of sustained virologic responders to corresponding pretreatment values as~     well as to historic interferon-treatment patients without virological response. It is~     expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at~     least in part - reversible by the successful application of modern IFN-free antiviral~     medication.~   "
44921|NCT02468999|"~     Research in animals and first experiments in humans indicate that insulin action in the~     brain regulates peripheral insulin sensitivity. One major organ might be the liver. Previous~     studies in humans showed that the human brain is an insulin sensitive organ in lean but not~     in overweight/obese persons. Therefore, this study will include lean versus overweight/obese~     persons.~      In this study, insulin action will be introduced by intranasal insulin administration in~     lean and overweight humans. As a control, placebo spray will be administered. To mimick the~     known spill over of small amounts of intranasal insulin into circulation, a small bolus of~     insulin will be administered over 15 minutes following placebo spray application.~      Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp~     and glucose uptake and endogenous glucose production will be assessed by tracer dilution~     technique. Autonomous nervous system activity will be addressed by heart rate variability.~     Involved brain areas will be addressed by fMRI before and after nasal insulin application.~   "
44922|NCT02468986|"~     Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is~     not influenced by traditional risk factors. Blood vessel dysfunction has been associated~     with heart disease and complications such as heart attack. The vessel dysfunction is thought~     to be mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen~     on ultrasound that improves after medications are given.~      The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid~     arthritis to determine if there is a difference in the protein expression in the cells that~     line the blood vessels compared to healthy people.~   "
44923|NCT02468973|"~     Medical students from zefad medical school volunteer to assist patients with chronic~     diseases to make lifestyle changes.~      Each student will work closely with a family doctor who finds patients who need and want it~     accompanied by a change he introduced them and guide him on health status, medication and~     change the desired objectives.~      In the program students will receive guidance on healthy lifestyle and support a patient to~     perform health changes in theoretical and practical. Training sessions will be held~     periodically, close supervision and guidance, counseling and cross-fertilization and updates~     from the scientific literature.~   "
44924|NCT02468960|"~     Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons~     before implantation of BVS (Bioresorbable Vascular Scaffold).~      Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of~     BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly~     reduced. This is expected to result in better short- and long-term outcomes.~   "
44925|NCT02468947|"~     The investigators want to assess the effectivity of different sample volumes in blood~     cultures.~   "
44926|NCT02468934|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) can safely and effectively reduce pain following total knee replacement. This~     study involves a device called the SPRINT System. The SPRINT System delivers mild electrical~     stimulation to nerves in the leg that received the knee replacement. The SPRINT System~     includes a small wire (called a lead) that is placed through the skin in the upper leg. It~     also includes a device worn on the body that delivers stimulation (called the SPRINT~     Stimulator).~   "
44927|NCT02468921|"~     The aim of the study is to investigate the influence benign non-toxic goitre and the~     surgical treatment hereof on the voice function before and 6 months following surgery.~   "
44928|NCT02468908|"~     This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple~     ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male~     and female subjects (on non-child bearing potential) will be enrolled to investigate single~     inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose~     levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered~     once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is~     the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The~     Clinical trial will involve 42 healthy participants. The trial is expected to last~     approximately 4 months.~   "
44929|NCT02468895|"~     Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be~     recruited. Patients will be approached, consented, have baseline demographics, diagnostics~     and disease activity measures recorded, and blood taken. The collection of data and~     biological material will mirror usual clinical practice as far as possible. Subjects will~     ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures~     recorded and questionnaires completed.~      In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also~     be collected for research purposes to measure a number of biomarkers for the assessment of~     diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy~     will be performed at baseline, and a further biopsy offered at 6 months to assess treatment~     response. A magnetic resonance (MR) muscle protocol will also be performed as per usual~     clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be~     repeated at 6 months. An existing electronic database entry system will be used for data~     entry and capture on an anonymised basis.~      The study will thus be based around diagnostic evaluations and outcome measures to improve~     quality of care in IIM.~   "
44930|NCT02468882|"~     Population studies associate a higher intake of cruciferous vegetables with a reduced risk~     of cancer. Studies identified PEITC and several active isothiocyanates in watercress extract~     that may have significant anticarcinogenic activity. Potential anticarcinogenic mechanisms~     include: preventing carcinogen activation by inhibiting phase I enzymes such as cytochrome~     P450s, by increasing cells' resistance through detoxification/antioxidant enzymes, by~     inhibiting cell cycle progression and/or by inducing apoptosis.~      These findings are justifiably interesting for the primary care setting and cancer primary~     prevention. Yet, these cellular effects of watercress supplementation may further prove~     useful in the modulation of cancer progression and disease recurrence. The present clinical~     trial of nutritional supplementation in cancer, intends to further explore the effects of~     therapeutic diets supplemented with nutraceuticals via watercress that may prove useful in~     DNA damage modulation, as well as in the global disease prognosis.~   "
44931|NCT02468869|"~     The goal of the proposed study is to assess the potential of information structuring for~     improving discharge communication. Specifically, the investigators aim to examine the~     advantages of an information-structuring skills training for physicians (compared to an~     emotion skills training) on discharge communication and associated patient outcomes, such as~     patients' information recall and adherence to physician recommendations. The investigators~     hypothesize that patients receiving structured discharge information from their trained~     physicians will be able to recall more information and show higher adherence to~     recommendations relative to controls (i.e., patients receiving discharge information from~     doctors trained in emotion-handling skills).~   "
44932|NCT02468856|"~     Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and~     information processing. Chronic effects include metabolic dysfunction, cardiovascular~     disease and cancer. Sleep deprivation affects quality of life when it causes errors in~     judgment, whether these occur behind the wheel of an automobile or in a hospital.~     Armodafinil, a non-amphetamine wakefulness promoting medication, indicated for excessive~     sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep~     disorder is used to mitigate the effects of sleep deprivation.~      This study will characterize the effect of armodafinil on driving simulator performance. The~     effects of armodafinil compared to placebo will be studied in a double blind crossover trial~     involving 10 healthy subjects with serial assessments at baseline and after extensive sleep~     deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated~     driving and neurocognitive assessments of vigilance, the relationship between brain activity~     and cognitive performance will be established.~   "
44933|NCT02468843|"~     Deep brain stimulation (DBS) is an effective surgical therapy for select Dystonia patients~     who are refractory to medications or who have generalized symptoms (e.g. patients with~     Early-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients~     typically experience significant improvement in disabling symptoms; however, detailed~     programming is always required, and stimulation-induced side effects commonly emerge.~     Clinicians may empirically vary voltage, pulse width, frequency and also the active contacts~     on the DBS lead to achieve observed optimal benefits.~      The majority of DBS patients undergo repeat surgeries to replace the implantable pulse~     generator (IPG) every 2.5 to 5 years. It has been demonstrated that, in dystonia patients,~     that higher settings are required for adequate symptomatic control, and that~     neurostimulators have a considerably shorter life when compared to neurostimulators from~     patients with essential tremor or Parkinson's disease. Additionally, several smaller studies~     have suggested that alternative pulse stimulation properties and pulse shape modifications~     can lower IPG battery consumption.~      Newer patterns of stimulation (regularity of pulses and shapes of pulses) have not been~     widely tested in clinical practice, and are not part of the current FDA device labeling.~     Novel patterns of stimulation do however, have the potential to improve symptoms, reduce~     side effects, and to preserve the neurostimulator life.~      The current research proposal will prospectively study biphasic pulse stimulation paradigms~     and its effects on dystonic symptoms. The investigators aim to demonstrate that we can~     tailor DBS settings to address dystonia symptoms, improve the safety profile, characterize~     distinct clinical advantages, and carefully document the safety and neurostimulator battery~     consumption profile for biphasic stimulation.~   "
44934|NCT02468830|"~     The objective is to evaluate the efficacy and safety of mirabegron to treat urinary~     incontinence in children with Overactive Bladder that are refractory and/or intolerant to~     antimuscarinics.~   "
44937|NCT02468791|"~     The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and~     the reference product - MabThera® (rituximab) and to demonstrate comparative safety and~     tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with~     moderate to severe active rheumatoid arthritis.~   "
44938|NCT02468778|"~     The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for~     use during high risk percutaneous coronary interventions (PCI) performed in elective or~     urgent, hemodynamically stable patients with severe coronary artery disease and depressed~     left ventricular ejection fraction.~   "
44939|NCT02468765|"~     Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases:~     depressive and bipolar disorders are twice as frequent as in general population.~      Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early~     stages of the disease's evolution, in cases of lightly or moderately disabled patients, with~     a recent evolution, with a minor form of the disease, even in Clinically Isolated~     Syndromes (CIS). Emotional disturbances are essentially linked to mood disorders of~     depression-type.~      Last ten years, emotional processing in multiple sclerosis cases was investigated in various~     trials, especially regarding the recognition of facial and emotional expressions. These~     studies reported data, supporting an impairment of the perception of emotion, particularly~     those with negative valence.~      The objective of this study is to investigate the link between recognition of facial and~     emotional expressions and depression in multiple sclerosis cases.~   "
44940|NCT02468752|"~     The primary objective of this study is to assess venous gas emboli load post diving when~     breathing normobaric oxygen compared to air.~      The secondary objectives are~        -  Assessment of DCS frequency~        -  Comparison of TCD and TTD consistency in venous gas emboli measurements~        -  Inflammatory activity in blood post diving~   "
44941|NCT02468739|"~     Monosialotetrahexosyl ganglioside (GM1) protect breast cancer patient from taxanes-related~     neurotoxicity.~   "
44942|NCT02468726|"~     In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must~     be free of solid matter so the endoscopist has a clear view, increasing the chance of~     detection of abnormalities. This is achieved through the use of bowel cleansing~     preparations, which are administered prior to the procedure. Enemas are the preferred method~     as they clear the lower bowel more quickly than oral formulations and do not require dietary~     restrictions.~      The medical device being tested in this clinical investigation is NER1008, an enema which~     contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the~     water content in the rectum and sigmoid colon, consequently increasing stool volume,~     resulting in rectal distension and subsequent distal colon emptying. The increased colonic~     luminal content stimulates the motility, propulsive transportation and rectal evacuation of~     the distal colon content.~      This study is designed to assess the performance of NER1008 in bowel cleansing and compare~     this with the performance of Fleet® enema, which is widely used for this purpose.~   "
44943|NCT02468713|"~     Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and~     docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil~     emulsions have not been commercially available until very recently. The Objective of this~     study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total~     parenteral nutrition in healthy Korean male subjects. This study is designed as a~     randomized, open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected~     every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride,~     glucose, and insulin.~   "
44944|NCT02468700|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone,~     0.4mg) depot when placed in the canaliculus of the eyelid in subjects who exhibit signs and~     symptoms of dry eye disease.~   "
44945|NCT02468687|"~     The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to~     humans at doses, which induce measurable immunological and anti-tumour effects in patients~     with myeloma who are resistant to or intolerant of lenalidomide and bortezomib.~   "
44946|NCT02468674|"~     The purpose of this extension study is to: 1) evaluate the durability of effect on skeletal~     muscle mass, strength and physical function upon discontinuation of treatment received in~     the core study and 2) evaluate the safety, tolerability, pharmacokinetics and efficacy of an~     additional 24 weeks of bimagrumab treatment in older patients with sarcopenia who previously~     received 24 weeks of treatment in the core study.~      The parallel group, placebo-controlled randomized withdrawal design will allow an unbiased~     comparison of the duration of effect upon withdrawal from 3 different dose regimens of~     bimagrumab and placebo on changes in muscle quantity and patient physical function in a~     population of older adults with sarcopenia.~   "
44947|NCT02468661|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended~     phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study,~     and to assess the anti-tumor activity and safety of INC280 alone, and in combination with~     erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients~     with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with~     acquired resistance to prior EGFR TKI.~   "
44957|NCT02468531|"~     Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It~     is confirmed that Xenon has the significant protective effect on important organs and has no~     suppression on the cardiovascular system. Furthermore, our earlier trial has already~     clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate~     ALI for Standford A acute aortic dissection. However the protection effect was restricted~     for the limited time. Aimed to enhance the protection effect of Xenon, we designed this~     randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary~     static Inflation with 50%,75% and 100% Xenon during CPB respectively.~   "
44958|NCT02468518|"~     This study will be conducted to observe any change in aerobic bacterial pattern on the skin~     of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.~   "
45050|NCT02467322|"~     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated~     cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of~     less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate~     Volume Paracentesis) of less than 5 litres without albumin .~   "
44948|NCT02468648|"~     Background:~      - Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New~     drugs have been developed, but they work better in some people than others. Researchers want~     to learn why.~      Objective:~      - To learn why new hepatitis C drugs sometimes don t work. Also, to learn if these drugs are~     safe and how well they work in people with different virus strains.~      Eligibility:~      - Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have~     either never been treated or treated previously with an interferon regimen (with or without~     ribavirin) that failed to clear the virus.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood and urine tests and complete questionnaires.~        -  Participants will have a Fibroscan an ultrasound that measures liver stiffness and~          other liver scans. They will have an electrocardiogram.~        -  Eligible participants will have a liver biopsy.~        -  Participants will be admitted to the Clinical Center. They will have a physical exam~          and blood tests, and complete questionnaires.~        -  They will take the first study drug dose as a tablet taken once daily.~        -  Participants will take the drug at home for 12 weeks.~        -  Participants will have 6 study visits. They will have blood and vital signs taken, and~          complete questionnaires.~        -  At week 4, participants will have another liver biopsy.~        -  After their last drug dose, participants will have 5 follow-up visits. They will have~          blood and vital signs taken, and complete questionnaires. They will discuss their~          medications and side effects. They may have another Fibroscan.~   "
44949|NCT02468635|"~     Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not~     fully reversible airway, where the severity of the disease and the prognosis is not~     determined solely by changes in lung function. Pulmonary rehabilitation is a~     multidisciplinary program of care for patients with chronic respiratory diseases,~     individually designed to optimize physical and social performance and autonomy of these~     patients, promoting improvement in functional exercise capacity, quality of life, reducing~     dyspnea, frequency and duration of hospitalizations and reduce the frequency of~     exacerbations of the disease. The overall objective of the research is to evaluate the~     effects of pulmonary rehabilitation program on exercise capacity, lung function, quality of~     daily life and reduction of dyspnea in patients with COPD. A study type randomized,~     open-label trial following the recommendations of the CONSORT (Consolidated Standards of~     Reporting Trials) will be held. The study will be conducted at the Clinic Physiotherapy~     Course of the School with a sample of 58 patients. The intervention will be performed~     sessions three times a week for 16 weeks (8 weeks for assessment and 8 weeks for adaptation~     and (pulmonary rehabilitation training). The PR (pulmonary rehabilitation) will last 60-120~     minutes each.O group A (control) will receive treatment of traditional pulmonary~     rehabilitation and without resistive training for upper limb (UL) and group B will receive~     the same treatment control with additional training of upper limb strength.~   "
44950|NCT02468622|"~     Despite the fact that migraine is a common disorder, the pathogenesis is still not fully~     elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous~     migraine-attacks will enhance our understanding and may point to new targets for drug~     development.~   "
44951|NCT02468609|"~     To investigate the diagnostic value of ultralow-dose computed tomography in the detection of~     pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to~     standard-dose-CT.~   "
44952|NCT02468596|"~     The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal~     excitability, using computerized analysis of the muscular response of musculus abductor~     pollicis brevis, to series of electrical stimulations of the median nerve.~      Because of its high sensitivity to small changes in axonal excitability, QTRAC may help~     improve the follow-up of patients suffering from peripheral neuropathy caused by~     anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability~     is early affected in this disease.~      The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with~     QTRAC results in healthy persons (matched for sex and age).~      A secondary aim is to determine whether or not the disease's clinical severity (measured by~     quantitative clinical scores) is correlated with the results of the QTRAC and could be~     predicted by a model based on the several parameters measured in the QTRAC exploration.~      100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough~     neurological examination with clinical scoring. The results will be compared with data~     (matched by sex and age) from the reference database on healthy subjects, that is provided~     with the QTRAC software.~      The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy~     patients, and that the clinical severity of the disease can be predicted by a combination of~     QTRAC-measured parameters.~   "
44953|NCT02468583|"~     This study is a double-blind, randomized, parallel group, proof of concept study comparing~     FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with~     post-traumatic osteoarthritis of the knee.~   "
44954|NCT02468570|"~     Phase 3 substudy enrolling approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with PKU~     who are concurrently participating in the 165-302 study.~   "
44955|NCT02468557|"~     This study will evaluate the safety, pharmacodynamics, pharmacokinetics (PK), and efficacy~     of single agent idelalisib and in combination with chemotherapy in adults with metastatic~     pancreatic ductal adenocarcinoma. This study will also define the the maximum tolerated dose~     (MTD) of idelalisib in combination with chemotherapy.~   "
44956|NCT02468544|"~     This is an open-trial pilot study in which adult methadone maintenance treatment patients~     who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments,~     non-adherence to medication) will be recruited to participate in a HIV primary care~     engagement study. The purpose of this study is to develop and test the feasibility and~     acceptability of a mobile phone-based health (mHealth) text messaging intervention to~     improve engagement in HIV primary care among substance abusing populations with HIV.~   "
44989|NCT02468115|"~     A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects~     after inoculation with influenza A virus (H1N1).~   "
44990|NCT02468102|"~     This prospective cohort study will provide information about:~      Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first~     time compared to patients who are prescribed standard of care for the first time.~      The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and~     the occurrence of non-infective liver disease.~   "
44959|NCT02468505|"~     Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual~     impairment face a fairly unique set of challenges as they transition out of secondary~     school. These students are often quite capable of succeeding in higher education and many of~     them have interest in pursuing advanced degrees, but the nature of their disability and~     associated deficits (e.g., poor time management and poor self-regulation) may impede~     success. Individualized, appropriately timed, and developmentally sensitive transition and~     support services may promote optimal outcomes for these young people. The goal of this~     project is to develop a comprehensive program to promote successful transition of students~     with ASD from high school to post-secondary education.~   "
44960|NCT02468492|"~     The purpose of this study is to evaluate the affect that platelet rich plasma has on the~     molecular an cellular functioning of the knee joint.~   "
44961|NCT02468479|"~     Chest/abdominal wall varices and spider nevi are two common presenting signs of liver~     cirrhosis. Their prognostic values remain unclear.~   "
44962|NCT02468466|"~     The purpose of this study is to examine the effectiveness of a community-based~     depression-screening program for suicide prevention among middle-aged adults, the~     investigators conducted a quasi-experimental intervention study, using a parallel cluster~     design with communities at municipal level as the unit of allocation and individuals as the~     unit of analysis.~   "
44963|NCT02468453|"~     This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment~     of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in~     the US and worldwide. The purpose is to collect data from the use of VELOS.~   "
44964|NCT02468440|"~     Treatment care of end-stage renal insufficiency is an important public health issue. The~     balance between patients waiting for a kidney transplant and available graft raises~     questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in~     this trial patients will experiment an educational therapy's program as soon as they~     register on the transplant list.~   "
44965|NCT02468427|"~     In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal~     teaching using a Training Video for learning how to perform an assisted delivery by vacuum~     extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills~     (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training~     is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.~   "
44966|NCT02468414|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment in Peritoneal Dialysis patients~   "
44967|NCT02468401|"~     There is a pressing need to find effective strategies for the prevention of contrast induced~     nephropathy in patients with advanced renal dysfunction. The current study was designed to~     assess the efficacy of a new protocol for preventing contrast induced nephropathy in~     patients with advanced renal dysfunction undergoing coronary interventions~   "
44968|NCT02468388|"~     The purpose of this study is to evaluate the clinical effect of chewing gum containing~     maltitol, on re-mineralization of early caries following daily chewing for 6 months by~     school children, compared to a xylitol gum, gum base and a no gum group.~   "
44969|NCT02468375|"~     The purpose of this study is to measure the treatment satisfaction after switching to~     mirabegron in patient with Overactive Bladder(OAB) who were unsatisfied with efficacy of~     antimuscarinic therapy or adverse event.~      Patient will take the mirabegron 50mg/day for 12 weeks, and the satisfation of the therapy~     will be measured with Treatment Satisfaction Questionnaire(TSQ), Global Response~     Assessment(GRA), OAB-q short form, OAB Symptom Score and Willingness to continue Questions.~   "
44970|NCT02468362|"~     Through a double blinded study, patients with low rectal cancer will be randomized into two~     equal groups to compare between the 5 year disease free survival as a primary outcome~     measure.~   "
44971|NCT02468349|"~     The proposed research aims to compare Left ventricular remodeling outcomes among patients~     with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided~     post-MI treatment vs. non-telemedicine guided treatment.~   "
44972|NCT02468336|"~     The objective of this study is to demonstrate that the investigational device,~     AngioDefender, is comparable to the established procedure referred to as 'brachial artery~     ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the~     brachial artery.~   "
44973|NCT02468323|"~     This study aims to compare the quality of perioperative antiemesis of palonosetron and~     ondansetron in patients undergoing cesarean section~   "
44974|NCT02468310|"~     Introduction Maternal and neonatal mortality continue to be to be prominent public health~     issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of~     Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal~     and child healthcare as a major challenge to the prevention of neonatal and maternal deaths.~     Effective interventions are required to make significant inroads in these areas.~      Objective To evaluate the effect of a SMS text messaging intervention to support clinical~     decision making by frontline health care professionals on neonatal and maternal mortality.~      Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana,~     involving 8 intervention and 8 control districts. The intervention consists of text~     messaging of standard protocols for maternal and neonatal care to front line health care~     providers in the region. A total of 17,040 pregnant women who are receiving care (including~     antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the~     region will be monitored through monthly aggregate data on outcome measures such as neonatal~     and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth~     asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as~     neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts~     to measure adherence to the safe motherhood protocol will be conducted. Stata software~     package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive~     analysis will be carried out to explore baseline characteristics of study groups while~     logistic regression will be applied to evaluate the effect of the intervention. A two-tailed~     statistical significant level of 0.05 will be used.~      Expected outcome We hypothesize that the intervention will improve both maternal and~     neonatal service delivery and health outcomes in the intervention areas.~   "
44991|NCT02468089|"~     A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting~     to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to~     treat SBP will be included and randomized into two treatment groups.~      Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.~   "
44992|NCT02468076|"~     This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of~     biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed)~     during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to~     obtain palliative biliary drainage via stenting~   "
44975|NCT02468297|"~     This randomized , double-blind, parallel-arm clinical trial was designed to study the~     efficacy and safety of the Electronic Acupuncture Shoes treatment on chronic low back pain~     patients.~      Chronic low back pain patients, aged 20-60, of both gender were recruited. As the primary~     outcome measure to assess the efficacy, 0-10 numerical rating scale was used. Secondary~     outcome measure included the speed of pain-relief.~      The number of samples in the experimental group and the control group ratio of 1 : 1 , is~     expected to total effective sample number is 60 . Experimental group will receive a six-week~     Electronic Acupuncture Shoes treatment and a week back to the clinic three times , subject~     to a total of 18 treatments , each course of about one hour . Subjects will take NSAID~     placebo in the first week of the course of treatment . After the second week of NSAID~     placebo on disabled.~      Control subjects will also accept the six- week treatment , control subjects will be equally~     back to the clinic three times a week , each group will be given to the subject of one hour~     each shoe pseudo electrotherapy treatment group and control group run by entering from the~     test day in the first week of the course , each taking ibuprofen 400mg, taken three times a~     day , the second week after the NSAID drugs on disabled.~   "
44976|NCT02468284|"~     The purpose of this trial is to look at how much a new trial drug get into body, such as~     when the drug concentration in your body reaches peak and how high the peak value is.~   "
44977|NCT02468271|"~     There is an increasing demand for researchers and regulatory bodies to use robust outcome~     measures in clinical trials which have evidence of validity, reliability, and~     responsiveness. There is currently little agreement on the core clinical endpoints that~     should be used in bronchiectasis. The importance of improving endpoint outcome measurement~     is well recognised and groups in other conditions have focused on activities to achieve~     consensus on a core set of outcomes for clinical trials. The Bronch-UK collaboration has~     explored the current evidence for clinimetric properties of commonly used outcome measures~     in bronchiectasis (e.g. forced expiratory volume in one second [FEV1], health related~     quality of life [HRQoL], and pulmonary exacerbations). The results of this extensive~     rigorous literature review of 68 papers clearly demonstrate that whilst there was good~     evidence for validity for key outcome measures in bronchiectasis there is little information~     available on their reliability (during periods of clinical stability) or response to~     treatment (effect sizes).~      The aim of this study is to explore the clinimetric properties of a range of outcome~     measures, in order to make recommendations for their use in clinical trials in~     bronchiectasis.~   "
44978|NCT02468258|"~     Patients & Methods: Eighty infertile women were randomly categorized into: Group EF (n=40)~     had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were~     subjecte to the standard down-regulation regimen followed by controlled ovarian hyper~     stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was~     collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained~     for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating~     factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining~     amount was used for EF in EF group and was discarded in control group. Pregnancy was~     diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical~     pregnancy~   "
44979|NCT02468245|"~     This study is being conducted by Bassett Healthcare Network in coordination with Bassett~     Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider~     consent to this study. This study will try to establish if nursing interventions can help~     improve patients' adherence to taking their oral chemotherapies as prescribed by their~     doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer~     diagnoses. Adherence to the prescribed treatment plan is very important to gain the best~     response to these types of treatments. The study will examine if nursing intervention via~     weekly phone calls may help improve adherence to oral chemotherapy treatment plans.~   "
44980|NCT02468232|"~     The purpose of this study is to assess the effect of LCZ696 at a target dose of 200 mg~     b.i.d. compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF)~     treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF~     hospitalization events in Japanese patients with stable chronic heart failure (CHF), New~     York Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular~     ejection fraction (LVEF) ≤ 35%).~   "
44981|NCT02468219|"~     This study will evaluate hemodynamic and functional changes resulting from valve~     intervention in patients with severe aortic stenosis undergoing valve replacement (AVR) or~     transcatheter aortic valve implantation (TAVI), and their influence on the~     pathophysiological mechanisms involved in cardiovascular rehabilitation.~   "
44982|NCT02468206|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric~     variceal rebleeding and improvement in survival.~   "
44983|NCT02468193|"~     The study aim is to investigate the efficacy and safety of Osilodrostat in patients with~     Cushing's syndrome due to causes other than Cushing's disease in Japan.~   "
44984|NCT02468180|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric~     variceal bleeding.~   "
44985|NCT02468167|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the management of acute~     gastric bleeding.~   "
44986|NCT02468154|"~     Assess whether by placing a custom made splint with heel in the immediate postoperative~     period until removal of the cast, the rate of pain, the number of healthcare interventions~     to maintain the off-loaded heel position and number of pressure sores in children wearing~     lower limb plaster casts is reduced.~   "
44987|NCT02468141|"~     To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from~     anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per~     day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory~     test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.~   "
44988|NCT02468128|"~     This is a randomized, double blind, placebo-controlled, single dose study to assess the~     safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for~     post-hemorrhoidectomy pain management.~   "
44993|NCT02468063|"~     The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS~     and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process~     of randomization.- The study is an open level study. The investigators will strictly follow~     the randomization table to give therapy as per the intervention arm.~        -  Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and~          terlipressin along with noradrenaline to maintain the MAP >65mm Hg.~        -  Intervention arm~             -  Arm (A) - Noradrenaline~             -  Arm (B) - Noradrenaline + low dose terlipressin~   "
44994|NCT02468050|"~     The breast cancer screening and diagnostic period is associated with heightened symptoms of~     anxiety and depression. Physical exercise has been found to effectively decrease these~     symptoms in healthy and diseased populations. This study aims to determine if a pre~     treatment exercise intervention can minimize symptoms of anxiety and depression in women~     undergoing screening for breast cancer.~   "
44995|NCT02468037|"~     High tissue iron is a risk factor for diabetes even within the broad normal range of normal~     human values. In order to demonstrate the benefits of reducing iron on glucose homeostasis~     and to better define the parameters for larger clinical trials, the investigators will~     subject individuals with prediabetes (impaired glucose tolerance, IGT) or early type 2~     diabetes to phlebotomy in order to reduce serum ferritin concentrations and determine the~     effect on glucose homeostasis as revealed by oral and frequently sampled intravenous glucose~     tolerance testing.~   "
44996|NCT02468024|"~     To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC~   "
44997|NCT02468011|"~     Previous studies reported that myoelectrical activity increased during whole body vibration~     (WBV). The investigators hypothesized that the change in soleus muscle length does not~     affect the whole body vibration induced soleus reflex muscle activity but the change in~     ankle angle affects the whole body induced soleus reflex muscle activity. The purpose of~     this study is to test this hypothesis.~   "
44998|NCT02467998|"~     The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide~     real world patient data from electronic health records submitted to meet Stage 2 Meaningful~     Use in order to understand the effectiveness and safety of various NPWT devices and methods~     among patients with chronic wounds and ulcers. Randomized, controlled trials to establish~     product efficacy routinely exclude patients with the co-morbid conditions common to patients~     seen in usual clinical practice and thus the results of these Randomized Controlled Trials~     (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among~     typical patients. Patient registries are also ideal for assessing long term safety issues in~     these devices.~   "
44999|NCT02467985|"~     Patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the~     shoulder in the first days following their intervention. Pain can be disabling and may even~     delay the discharge of patients. Several techniques have been proposed to reduce this~     problem. Promising strategies include the reduction of CO2 insufflation flow, lung~     recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical~     procedure to force gas discharge. The investigators wish to perform a randomized controlled~     trial with 160 women, who will assess the effect of a combined approach, combining for the~     first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the~     Trendelenburg position at the end of surgery and flow of insufflation reduces carbon dioxide~     (CO2) forming the pneumoperitoneum during surgery, on the intensity of shoulder pain~     postoperatively. In the control group the evacuation of the pneumoperitoneum will be done by~     opening the trocars and external abdominal pressure at the end of surgery. No study to our~     knowledge has tested the active aspiration maneuvers gas after laparoscopic surgery in~     gynecology. The study will be preceded by a pilot study in 15 participants, who will be~     assigned to the control group to determine the basic rate of referred pain in the shoulder~     in our people and improve test management.~   "
45000|NCT02467972|"~     The addition of fructans or unripe banana flour to frozen meals can change the hormonal~     parameters related to hunger and satiety, improve the bowel movements and increase in~     colonic bacteria population measured by microbiological determinations (qPCR). The inulin no~     can change bowel movements and increase in colonic bacteria population measured by~     microbiological determinations (qPCR)~   "
45001|NCT02467959|"~     The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency~     physician performed ultrasound in the diagnosis of acute appendicitis.~   "
45002|NCT02467946|"~     Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover,~     Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these~     reasons, questions arise whether ABVD could be still considered the standard treatment in HL~     patients aged > than 60. Regimens containing other alkylators such as CHOP proved even~     superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with~     Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine)~     proved very active in a pioneer study, reporting the preliminary results of a phase 1~     multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For~     all these reason the investigators decided to test the association of an alkylator with an~     innovative mechanism of action and a very safe toxicity profile in the elderly such as~     Bendamustine (Be) with BV in untreated elderly HL patients.~      The combination of BV and Be, investigated in this study, might represent an innovative~     treatment alternative for HL patients older than 60 years of age, especially for those of~     them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable.~     However, even when ABVD is given as upfront treatment for elderly HL patients, it is~     associated with substantial dose reduction, treatment delay, toxicity, and treatment-related~     mortality, with treatment outcomes remaining much inferior to those obtained in younger~     patients. This drug association is expected to be safe, well-tolerated and to demonstrate~     higher efficiency compared with ABVD. In this setting, it is expected that this therapy~     could be offered to the large majority of elderly patients with a full treatment completion~     reached in up to 80% of these patients.~      Thus, the aim of this study will be to assess safety and efficacy of the above association.~   "
45003|NCT02467933|"~     Abusive prescribing exposes patients to unnecessary health risks and results in wasteful~     public expenditures. This study will evaluate an innovative approach to fighting abusive~     prescription: sending letters to suspected inappropriate prescribers warning them that they~     are outliers compared to their peers and have been flagged for review. The study will target~     high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the~     investigators will assess the effect of the letters on prescribing of Seroquel, receipt of~     Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes~     of patients.~   "
45004|NCT02467920|"~     Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching~     Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human~     Insulin and Metformin: a Randomized, Open, Parallel trial.~   "
45005|NCT02467907|"~     This study is to assess safety as defined by the frequency and severity of gastrointestinal~     (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants~     treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel~     and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic~     cervical cancer. In addition, this study will include evaluation of the overall safety~     profile of bevacizumab in combination with paclitaxel and carboplatin in this setting,~     assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time,~     and evaluation of efficacy.~   "
45006|NCT02467894|"~     A two-group randomized clinical trial testing whether group-based care will help improve~     blood pressure control in adult and adolescent patients with chronic kidney disease and~     hypertension.~   "
45007|NCT02467881|"~     Diabetes Prevention Program translational efforts, such as the Group Lifestyle Balance~     Program (GLB), have been shown to be effective in reducing weight and modifying diabetes and~     CVD risk factors in a variety of diverse community settings. Although one of the two primary~     goals of these DPP translation programs focuses on increasing physical activity levels, few~     published DPP translation studies reported results on change in physical activity with only~     one study reporting activity levels from an objective measurement instrument. In order to~     completely understand the role that physical activity plays in making healthy lifestyle~     change, it is critical that we validate the impact of activity using a valid and reliable~     objective measure. In addition, current studies suggest that decreasing time spent sitting~     may have a positive health impact separate from the effects of participating in planned~     bouts of moderate intensity activity. Therefore, we propose to examine the impact of a~     modified version of the GLB program, which will focus on decreasing sedentary/sitting~     behaviors. The results of this project will provide information regarding best options for~     physical activity within lifestyle intervention programs, focusing both on verifying the~     current role of physical activity in lifestyle intervention using an objective measure and~     on examining an alternative intervention option for translation efforts.~   "
45008|NCT02467868|"~     This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of~     MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving~     Neoadjuvant or Adjuvant Chemotherapy.~   "
45009|NCT02467855|"~     The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult~     participants with essential hypertension.~   "
45010|NCT02467842|"~     All participants will receive a single dose of their assigned vaccine on Day 0. They will be~     followed up for immunogenicity and safety through Day 21 post-vaccination. The serious~     adverse events are collected for 6 months post-vaccination.~   "
45011|NCT02467829|"~     The aims of this study are to investigate what effect altering handle height of posterior~     walkers has on forces through the walker, posture, efficiency, stability, speed, turning and~     comfort, and to obtain data which helps therapists understand the bio-mechanics involved~     during use and if this alters depending on age, posture or strength. All participants will~     have cerebral palsy. This will allow informed prescription of walkers and identify potential~     for redesign to improve efficiency, promote strengthening or improve posture to maximise~     children's potential to continue functional walking into adulthood.~   "
45012|NCT02467816|"~     This study will evaluate an innovative school lunch intervention that is designed to~     increase school meal participation and improve dietary intake among middle and high school~     students.~   "
45013|NCT02467803|"~     Fractures of the proximal humerus and the humeral head are most common injuries and the~     management is challenging. Functional therapy with short immobilization, followed by an~     accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient~     management option. This prospective randomized study is aim to assess the function of the~     upper extremity of patients who will be assigned to nonoperative treatment of a proximal~     humeral fracture. The primary objective is the Constant score. Secondary objectives are the~     Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range~     of motion (ROM), pain and depression level with Beck Depression Scale.~   "
45014|NCT02467790|"~     To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or~     normal renal function who were administrated subcutaneously single dose PEX168.To evaluate~     dose adjustment of PEX168 administered in patients with renal insufficiency and provide a~     scientific basis in patients with renal insufficiency of rational drug use.~   "
45015|NCT02467777|"~     Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.~   "
45016|NCT02467764|"~     The hip or knee is a validated treatment of end-stage osteoarthritis, and these~     interventions commonly make a significant improvement in the quality of life of patients.~     Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of~     infected or not infected character directly influences the surgical conduct. It is therefore~     recommended that the positive or negative diagnosis is made in the most reliable way~     possible, but no single element only allows a low diagnosis. The concomitant use of several~     clinical, radiological and aggregated into a composite score history could help facilitate~     this preoperative approach during reoperation on prosthetic joint~   "
45017|NCT02467751|"~     Metabolic profile in women of different body composition with polycystic ovary syndrome.~   "
45018|NCT02467738|"~     This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head~     and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy,~     also known as internal radiation therapy, uses radioactive material placed directly into or~     near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry~     radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium~     Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be~     in the tissue after surgical removal of the tumor.~   "
45019|NCT02467725|"~     The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo~     development and reproductive potential in comparison to static culture.~   "
45049|NCT02467335|"~     A single oral dose study in subjects with hepatic impairment and healthy control subjects.~     Subjects will stay at the clinical facility where interval blood samplings will be obtained~     and examined for drug effect.~   "
45051|NCT02467309|"~     The purpose of this study is to determine whether deficiency of Vitamin D has association~     with outcomes of children with bacterial meningitis.~   "
45020|NCT02467712|"~     It is generally accepted that the fungal infection on a joint prosthesis is to be treated in~     two surgical time: implant removal and prosthetic reconstruction. The service took the~     option for over 10 years to treat bacterial infections in joint replacement by a change in~     time. In four recent cases the diagnosis initially suspected of bacterial infection has been~     restated on intraoperative bacteriological examinations fungal infection. It is therefore a~     potentially harmful side effect of the chosen treatment option, but 4 patients in question~     were all cured of their fungal infection after a postoperative antifungal therapy. The~     objective of this study is to report these cases for discussion on the therapeutic choices~     in fungal infections on joint replacement.~   "
45021|NCT02467699|"~     The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this~     intervention usually provides a significant improvement in the quality of life of patients.~     However, a significant percentage of patients (up 30%) say disappointed with the outcome of~     the intervention. One hypothesis that could explain these poor results might be poor~     adaptation of the implants to the patient's anatomy, resulting in a non-physiological~     kinematics for the patient. Multiple studies try to obtain an individual adaptation of the~     intervention according to multiple criteria. The measurement of the kinematics of the knee~     before surgery could participate in this process.~   "
45022|NCT02467686|"~     The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of~     women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.~   "
45023|NCT02467673|"~     The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO)~     transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein~     (CRP), and cardiovascular risk factors in postmenopausal women.~   "
45024|NCT02467660|"~     1. Telephone Eligibility Screening~        2. Baseline Visit, includes online questionnaires, physical measures, cognitive tasks,~          voice recordings, physical recordings of brain waves, heart rate, breathing rate, and~          sweat during computer tasks, collect saliva samples and respond to handheld device that~          rings randomly for the two days following the visit~        3. Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an~          internet-based Health & Wellness Education program, or (c) no training. IF assigned to~          receive a training program, participants complete weekly one-hour online trainings and~          daily home practice for 6 weeks~        4. Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline~        5. All participants receive Meditation and Education programs after the Endpoint Visit~        6. Online questionnaire follow-up 6 months after the Endpoint~   "
45025|NCT02467647|"~     To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on~     the patients with multiple myeloma in maintain therapy.~   "
45026|NCT02467634|"~     A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with~     bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.~   "
45027|NCT02467621|"~     Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however~     the quantity and quality of evidence is low and potential harm has been reported.~      The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton~     pump inhibitor in adult critically ill patients in the ICU.~   "
45028|NCT02467608|"~     Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs~     Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis~   "
45029|NCT02467595|"~     This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on~     the anesthetic induction and emergence with fentanyl in children undergoing~     adenotonsillectomy.~   "
45030|NCT02467582|"~     Following complete resection of their primary tumor, potentially eligible stage II or stage~     III colon cancer patients will undergo central PIK3CA testing. Patients with somatic~     mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a total of 3~     years or until disease recurrence, patient death or withdrawal of consent, whichever occurs~     first. Patients will be followed up for 10 years from the date of surgery.~      The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not~     impact on the indication to give (or not to give) adjuvant chemotherapy.~   "
45031|NCT02467569|"~     The purpose of this study is to assess the pharmacokinetics，safety and tolerability of~     Hemay020 and to determine the recommended dose for future Phase II study as well as to~     obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors.~     The study will be conducted in two parts. Part one, testing will be done on up to 16-31~     subjects to determine the safety and tolerability of Hemay 020 in patients with advanced~     solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be~     added to the trial to better define the tolerability and preliminary efficacy of Hemay020.~   "
45032|NCT02467556|"~     A ten week open label study intervention to evaluate the outcome for a psychological~     intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS~     patients.~   "
45033|NCT02467543|"~     Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in~     more than 50% of women during their reproductive years. Primary dysmenorrhea describes~     cyclic uterine pain without any identifiable or underlying causes. Menstrual pain results as~     a consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory~     mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal~     anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum~     opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of~     dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no~     research assessing its efficacy in the homoeopathic form.~      The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of~     primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire~     (SF-MPQ-2) and visual analogue scale (VAS) respectively.~   "
45034|NCT02467530|"~     This is an intervention study of the effects of food preparation on the gut bacteria in~     patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention~     consistent of consuming low amounts of advanced glycation end products (AGEs), the products~     of protein and sugar interaction during food processing and preparation using high direct~     heat.~   "
45035|NCT02467517|"~     The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment~     to that of a placebo in patients with refractory neuropathic pain.~      The secondary outcomes are:~        1. - To compare the additive analgesic efficacy of prior administration of magnesium~          sulfate to that of placebo and ketamine only, on the effectiveness of intravenous~          ketamine treatment,~        2. - To study the evolution time of pain and analgesia after the intravenous~          administration of ketamine and placebo,~        3. - To study the correlation of the analgesic response to administered products~          respectively ketamine, ketamine and magnesium sulfate, placebo.~   "
45036|NCT02467504|"~     Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by~     symmetric poly-arthritis usually involving the small joints of the hands and feet. In~     addition, various extra-joint manifestations may develop. Several immunomodulating agents~     have been attempted in the treatment of RA without achieving satisfactory results.~     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,~     which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose~     IL-2 could be a novel therapy in active RA patients. This clinical study will test the~     efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a~     single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the~     effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2~     (N = 30) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 30)).~   "
45037|NCT02467491|"~     The purpose of this study is to explore the feasibility and acceptability of a new physical~     activity technology (Jintronix) based on TV screen, virtual games and motion sensing cameras~     among pre-disabled older adults.~   "
45038|NCT02467478|"~     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels~     which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the~     blood. Research has shown that improving the survival of these special blood cells may~     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart~     disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine~     used along with insulin or with oral medications to lower blood sugar in people with Type 2~     diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4)~     inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2~     diabetes.~      Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor~     stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The~     investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce~     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose~     metabolism control~   "
45039|NCT02467465|"~     The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel.~     About 10% to 20% of the population suffer once during their lifetime. PF concept began to~     describe at the end of XX century through the discovery of new clinical and~     histopathological signs of the plantar fascia. The difficulty of diagnosis, understanding~     and treatment of PF require us to develop new treatment avenues to improve the approach and~     the understanding of it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS)~     and myofascial trigger points (MTP) of muscle associated with the pathology, it may be a~     good treatment strategy, as demonstrated in the treatment of MPS in other body regions such~     as the neck, shoulder or the lumbar spine.~   "
45040|NCT02467452|"~     The purpose of the study is to demonstrate the triple combination of beclometasone~     dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality~     of life in COPD patients (Chronic Obstructive Pulmonary Disease).~   "
45041|NCT02467439|"~     The primary purpose of this research is to assess the benefit of an unaware intervention~     package for identifying high risk persons who are unaware of their HIV infection status.~     This intervention package includes screening for acute HIV infection, contract sexual~     partner referral, and peer referral.~   "
45042|NCT02467426|"~     This is an observational study of isolated thoracic perfusion with subsequent hemofiltration~     to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in~     malignant pleural mesothelioma.~   "
45043|NCT02467413|"~     The primary objective of this study is to evaluate the efficacy of BAC patients with~     Alzheimer's disease or vascular dementia.The secondary objective of this study is to~     evaluate the safety of BAC patients with Alzheimer's disease or vascular dementia.~   "
45044|NCT02467400|"~     This study is designed to answer the question as to whether the sympathetic nervous system~     is an important determinant of bone metabolism in humans.~   "
45045|NCT02467387|"~     A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of~     ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic~     heart failure.~   "
45046|NCT02467374|"~     The purpose of this study is to find out more about how the brain stores emotional learning~     in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human~     beings learn not to fear. We are also interested in learning about how behavioral therapy~     (BT) for OCD affects emotional learning in the brain. We hope this study will help us~     understand why people with OCD cannot control unwanted fear and to develop better treatments~     for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive~     12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking~     right-handed individuals 18-60 with OCD and individuals with no psychiatric history.~     Participation includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist~     followed by BT, questionnaires, and up to six (6) MRI scans. You may receive up to $500 for~     your participation and reimbursement for parking.~   "
45047|NCT02467361|"~     This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination~     with immunotherapy in adult patients with advanced cancers. The goal of the study is to~     determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.~   "
45048|NCT02467348|"~     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on~     chronic Liver Failure). ACLF will be randomize into~      Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8~     gms/L of ascitic fluid~      Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin~   "
45052|NCT02467296|"~     Currently, the recommendations for sodium intake restriction for patients with heart failure~     are mostly based on expert consensus and observational evidence, whereas smaller randomized~     studies have actually suggested that strict dietary sodium reduction may be harmful in heart~     failure. In the present clinical trial pilot study, the investigators plan to collect data~     on enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in~     heart failure patients, with prepared food containing two different levels of sodium (1,500~     mg and 3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The~     goal is to inform the design of a fullscale clinical trial that will provide more definitive~     evidence for dietary sodium recommendations in heart failure.~   "
45053|NCT02467283|"~     Current concepts of the causes of periodontitis implicate a bacterial infection as the~     primary cause of the disease. Several bacterial species residing in a biofilm on tooth~     surfaces are closely associated with periodontitis. Chronic periodontitis (CP) is initiated~     and sustained by bacterial plaque, but host defense mechanisms play an integral role in its~     pathogenesis.~      Gene expression profiling is a powerful means of generating comprehensive genome-level data~     sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and~     provides significant insight information for these diseases. Gene expression profiling may~     provide an evidence for involving genes in the pathogenesis of CP and generate further~     information other than clinical signs and symptoms of CP.~      The aim of this study was to identify gene-expression patterns of patients with chronic~     periodontitis by whole-transcriptome gene-expression analyses.~   "
45054|NCT02467270|"~     The purpose of this study is to compare and characterize the efficacy and safety of~     ponatinib in patients with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in~     a range of doses.~   "
45055|NCT02467257|"~     The purpose of this study is to determine whether Gum Arabic is effective as fetal~     hemoglobin inducing agent for sickle cell anemia patients.~   "
45056|NCT02467244|"~     The aim of this study is to evaluate plasma adiponectin level, insulin resistance,~     cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also~     to investigate the effect of levothyroxine on these parameters. The study may explore the~     lacunae in present treatment protocol and can suggest the possibilities of add-on therapies~     for a better management.~   "
45057|NCT02467231|"~     Women of reproductive age who will receive treatment for cancer that includes chemotherapy~     may participate in a study measuring ovarian function over time. Eligible women are asked to~     complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound,~     and a blood test before, during and after cancer treatment.~   "
45058|NCT02467218|"~     Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians.~     Although the etiology and pathophysiology are poorly understood, there is a well-recognized~     association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia,~     abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM.~     Pharmacological and non-pharmacological strategies are directed to control symptoms such as~     pain, fatigue, non-restorative sleep and depression.~      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a~     hyperbaric chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of~     HBOT is based on a dramatic increase in the amount of dissolved oxygen carried by the blood~     which enables oxygenation of ischemic areas with compromised circulation. It also activates~     oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory~     response, induces brain neuroplasticity and possesses analgesic effect.~      While some interventions offer benefit for some patients, additional treatment alternatives~     are needed for patients with FM in whom currently available options are either ineffective~     or poorly tolerated. Given its physiological effect, HBOT could be considered as a potential~     therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system~     and controlling FM symptoms. The results from this study could therefore provide new~     information supporting the basic science underling the pathophysiology of this disease and~     stimulate novel therapies for patients suffering with FM.~   "
45059|NCT02467205|"~     The overall aim of this randomized control trial study is to investigate the effectiveness~     of a six-month, community based, pedometer supported, walking programme, along with an~     education programme incorporating behavioural change techniques on steps count and sedentary~     time, disease activity, functional capacity and cardiovascular risk of people within the~     first five years of being diagnosed with RA.~   "
45060|NCT02467192|"~     Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and~     specificity of clinical signs as well as images from chest radiography (RT). New diagnostic~     tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a~     weak dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide~     additional accuracy in the etiological clarification of pneumonia in elderly people.~      As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3~     months of follow-up) prospective study including the Divisions of Internal Medicine,~     Rehabilitation, Geriatrics and Radiology of the University Hospitals of Geneva. In this~     study, patients >65 years old with a clinical suspicion of low respiratory tract infection~     (LRTI) will be included. They will be prescribed antimicrobial therapy. Both chest~     radiography and low-dose thoracic CT will be performed within the first 72 hours after~     admission, as will blood tests and a nasopharyngeal swab.~      The clinician's diagnosis, both before and after the results of the CT, will be compared at~     the end of the study to the adjudication committee's diagnostic opinion which will have~     access to all available clinical, laboratory and chest X-ray data and which will be~     considered the gold standard. At the end of the study, all the CT images will be~     blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of~     pneumonia will be assessed, both for its sensitivity and specificity in this population.~      During the first 12 months of the study, all patients will undergo a systematic~     nasopharyngeal swab at admission and at discharge, from which eluates will be conserved.~     During the next 12 months, virological and bacteriological polymerase chain reactions (PCR)~     will be performed, using new diagnostic tools, in order to determine the etiological~     diagnosis in this population and to evaluate the impact of the new tools in the management~     of pneumonia for this population.~      Analysis of these data will allow clinical, radiological and microbiological correlation.~   "
45061|NCT02467179|"~     The purpose of this study is to compare standard manual and robotically controlled catheter~     ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of~     the CTI is standard treatment for patients with a history of atrial flutter, and those~     undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation~     are used in standard clinical practice at The University of California, San Diego (UCSD) for~     ablation.~   "
45181|NCT02465619|"~     The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015~     to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion~     criteria will be included in the study and will be categorized and evaluated. The patient~     will followed over a period of 3 months.~   "
45062|NCT02467166|"~     The purpose of this study is to determine if the use of Circa™ temperature monitoring system~     during ablation procedures will reduce the risk of esophageal lesions or damage. Esophageal~     lesions caused by ablation could later develop into a potentially fatal atrio-esophageal~     fistula, which is hole between the upper chamber of the heart and the esophagus. Although~     development of atrio-esophageal fistula following atrial fibrillation ablation is extremely~     rare, the complication is severe and potentially life-threatening. Therefore, monitoring of~     esophageal temperatures has been adopted to prevent the development of esophageal lesions.~     The Circa™ temperature monitoring system allows cardiac electrophysiologists to monitor and~     thereby limit temperatures as well as duration of ablation in the esophagus throughout the~     procedure.~   "
45063|NCT02467153|"~     This study aims to determine whether vitamin D3 supplementation is any more effective in~     improving musculoskeletal function when combined with exercise training compared with~     exercise training alone.~   "
45064|NCT02467140|"~     A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia~     repair comparing the ProGripTM self- fixating mesh with tack fixation.~   "
45065|NCT02467127|"~     To date there are conflicting data concerning a correlation between plasma vitamin D levels~     and headache.~      The aim of this study was to evaluate plasma vitamin D levels in patients with headache~     admitted to the Center of Headache of Pugliese Ciaccio Hospital.~   "
45066|NCT02467114|"~     Attention can be defined as the preparedness to rapidly and accurately respond to stimuli~     coming from the investigators environment and to effectively select between relevant and~     irrelevant information. According to a current model, visual attentional control is based on~     two separate groups of brain regions, so called brain networks. These networks control~     different attentional aspects (e.g., spatial/non-spatial attention) and they interact with~     each other. A disruption of these interactions can lead to attentional disorders such as~     hemispatial neglect. Patients with hemispatial neglect have difficulties directing their~     attention to the left visual field and they act as though the latter does not exist.~      To date, the interactions between the two attentional networks are poorly understood. The~     aim of this study consists in further clarifying different aspects of these interactions and~     their influence on visual perception in healthy participants and in patients with~     hemispatial neglect. Transcranial magnetic stimulation (TMS) will be the principal method~     applied in this study. TMS is a painless and non-invasive method, with which the activity of~     brain areas can be influenced temporarily. This allows us to draw conclusions regarding the~     functions and interactions of these brain areas.~      This study is designed to have a significant impact on the basic understanding of~     attentional control in the human brain and it can benefit the comprehension and treatment of~     attentional disorders, such as hemispatial neglect.~   "
45067|NCT02467101|"~     The purpose of this study is to determine the efficacy of treatment with intralesional~     injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with~     placebo), between three months, six months and baseline.~   "
45068|NCT02467088|"~     Premenstrual Syndrome (PMS) is a group of physical, mental and behavioural symptoms that~     occur cyclically through the luteal phase of the menstrual cycle and resolve within three~     days of the onset of menstruation. Many women are affected by the physical and psychological~     symptoms of PMS. The symptoms of PMS can change behaviour and wellbeing of women which has~     an impact on families, social life and work. Research has shown that women with PMS reported~     additional days missed at work compared to women that do not suffer with PMS. A study done~     by Brohi et al. (2011) showed that PMS is a common problem that occurs in 81.25% of women~     and has an adverse impact on a woman's quality of life. Conventional treatment is limited,~     not always effective and is associated with many side effects. Research using individualised~     homeopathic treatment, known as the homeopathic similimum, in PMS has shown to be well~     tolerated as well as have a positive impact on the symptoms of PMS although further research~     is warranted in this regard. There have not been any studies done on homeopathic treatment~     in Indian females in South Africa.~      The aim of this study is to determine the effect of individualised homeopathic treatment on~     females of Indian origin who are suffering with symptoms of PMS, using observational~     studies.~   "
45069|NCT02467075|"~     This double-blinded placebo-controlled non-inferiority study will examine the incidence and~     significance of contrast-induced acute kidney injury following intravenous iodinated~     contrast material administration in subjects with stage IIIB or stage IV chronic kidney~     disease.~      Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to~     evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive~     either weight-based low-osmolality iodinated contrast material or saline. The primary~     outcome measure will be the incidence of stage II AKI by AKIN criteria.~   "
45070|NCT02467062|"~     The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting~     and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or~     aortic valve diseases.~   "
45071|NCT02467049|"~     In the prevention of thrombosis related to catheter placement it is important to have a~     right position of the catheter tip. Therefor we want to assess which technique is the most~     successful in the placing of a PICC.~   "
45072|NCT02467036|"~     The purpose of this study is to evaluate whether a behavioral weight loss group in~     conjunction with a prescribed breakfast can help children between 8 and 12 years of age~     change their behaviors to help them lose weight and become healthier.~   "
45086|NCT02466854|"~     The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with~     diagnosis of Acute Coronary Syndrome) registry is an international observational database of~     bleeding outcomes for patients who are discharged with diagnosis of ACS and underwent~     Percutaneous Coronary Intervention (PCI), including myocardial infarction or unstable~     angina.~      BleeMACS registry enrolls a total of more than 15,000 patients, including data from 16~     hospitals in 11 countries: North America (Canada), South America (Brazil) Europe (Germany,~     Netherlands, Poland, Spain, Italy, Macedonia, Greece), and Asia (Japan and China).~      The end-point of this study is to characterize patients at high risk of bleeding and to~     develop a risk score to accurately predict the risk of major bleeding within the first year~     after discharge from the hospital for an ACS.~   "
45182|NCT02465606|"~     The primary objective for this study is to evaluate the safety of lebrikizumab compared with~     Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic~     Dermatitis (AD) that is inadequately controlled with TCS.~   "
45073|NCT02467023|"~     The purpose of this research study is to see if electrical stimulation of the leg muscles~     will improve strength in patients receiving mechanical ventilation in the intensive care~     unit (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some~     CCI patients develop persistent inflammation/immunosuppression and catabolism syndrome~     (PICS), and they have morbid long-term outcomes. CCI patients with PICS often develop severe~     limb muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in~     PICS is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and~     inactivity. Despite the seriousness of limb muscle weakness in CCI patients receiving~     mechanical ventilation, little is known about exercise strategies to treat this problem.~     There is limited knowledge about how strength training impacts inflammation and catabolism~     in CCI patients. In addition, an assessment of the effect of exercise on markers of~     inflammation and protein catabolism on muscle samples obtained with biopsy techniques and~     venous blood samples will be performed. This project will further understanding of how~     treating CCI-related muscle weakness with strength training cannot only improve muscle~     function, but also potentially blunt the inflammation and catabolism of PICS.~   "
45074|NCT02467010|"~     Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated~     high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide,~     also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory~     rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a~     myeloma functionality.~      The objectives of the present study are whether patients with refractory or relapsed~     multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will~     benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable~     side-effects. Recently two studies have shown with thalidomide that maintenance therapy~     might improve EFS and one study also the OS.~   "
45075|NCT02466997|"~     Multicentric French parallel double-blind randomized versus placebo study~   "
45076|NCT02466984|"~     Subcutaneous (SC) route has become a standard of care of many drugs administration in~     palliative medicine. A preliminary study showed that, although it was widely adopted among~     palliative care practitioners for routinely prescribed medications, standards of proof are~     still lacking for many molecules. Among them, metoclopramide is a largely employed drug for~     nausea and vomiting treatment, particularly in palliative care and oncology. Therefore, the~     investigator aim to study absorption and efficacy of subcutaneous administration of~     metoclopramide.~   "
45077|NCT02466971|"~     This randomized phase II trial studies radiation therapy and cisplatin with triapine to see~     how well they work compared to the standard radiation therapy and cisplatin alone in~     treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage~     II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and~     shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether radiation therapy~     and cisplatin are more effective with triapine in treating cervical or vaginal cancer.~   "
45078|NCT02466958|"~     The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to~     placebo for the treatment of depression in older adults.~   "
45079|NCT02466945|"~     The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in~     patients with dentinal hypersensitivity.~   "
45080|NCT02466932|"~     This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters~     in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were~     measured by GD-SA and relationships between all anterior segment parameters obtained by this~     device and birth weight were analyzed.~   "
45081|NCT02466919|"~     The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel~     10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential~     therapy.~   "
45082|NCT02466906|"~     This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy~     for patients with resectable stage III colon cancers.~   "
45083|NCT02466893|"~     Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe~     and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has~     shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been~     shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials~     utilizing advanced imaging to identify patients with large vessel occlusions amenable to~     intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical~     therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT~     approach has shown superior technical results with similar functional outcomes while~     lowering procedure time and device costs versus traditional stent retriever as a first line~     therapy approaches~   "
45084|NCT02466880|"~     This study aims to evaluate a culturally appropriate, low cost and sustainable management~     plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials~     confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote~     improvements in diet, increased physical activity and weight loss. Translation of lifestyle~     intervention to real-life settings however remains a major challenge.~      The investigators therefore propose a diabetes management trial for T2DM patients using~     telemedicine. This project's innovations include the use of information technology to~     deliver messages to the physicians while similarly involving family members of diabetics to~     manage the patient's condition collectively. This creates a sense of well-being, empowering~     the individual as well as the community to be responsible for their own health and~     well-being~   "
45085|NCT02466867|"~     This is an open label, multi-center, multi-application pharmacokinetic study in pediatric~     subjects with tinea corporis.~   "
45122|NCT02466386|"~     To evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15,~     20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity~     Disorder (ADHD). Subjects will be enrolled into this study from antecedent study SPD489-211~     (NCT02402166) or SPD489-347.~   "
45087|NCT02466841|"~     Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most~     common compressive neuropathy of the upper extremity (carpal tunnel is the most common).~     Patients who fail conservative treatment (activity modification, splinting, medications) are~     offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve~     at the elbow, but the ideal release has not been determined. These techniques vary from~     simple decompression of the nerve (in-situ release, endoscopic release), to decompressing~     the nerve and moving it anteriorly to take tension off the nerve (subcutaneous~     transposition, sub-fascial transposition, sub muscular transposition), and removing part of~     the medial epicondyle (medial epicondylectomy). Each procedure has purported benefits and~     also potential complications. Simple in-situ release has the benefit of shorter operative~     times and less surgical dissection, however, the nerve may subluxate post-operatively and~     cause persistent pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial~     transposition, sub muscular transposition) prevent subluxation and take tension off the~     nerve, however, they require more dissection, larger incisions, and also partially~     devascularize the nerve. Medial epicondylectomy prevents subluxation and decompresses the~     nerve, but some patients may have a prolonged recovery and persistent pain from removing~     part of the bone.~      The purpose of this study is to prospective evaluate patients undergoing cubital tunnel~     release according to the standard practice and preference of their surgeon. The~     investigators plan to compare the different techniques at standard post-operative intervals.~   "
45088|NCT02466828|"~     Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults.~     Despite recent diagnostic and therapeutic advances, including aggressive surgical resection~     and chemoradiation, the prognosis of GBM has improved only slightly over the past two~     decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM~     that contributes to poor outcome through multiple mechanisms such as 1) overexpression of~     enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM~     and 2) increase expression of cancer stem cells which are more resistant to radiation.~     Hypoxic tumour regions are associated with higher rates of progression and recurrence.~      In this study the investigators will use an advanced MRI technique called qBOLD to~     non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators~     take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron~     supplement, and utilize two recent technical advances not previously used in human tumours~     to quantitatively measure oxygenation in GBM.~      Prior knowledge of hypoxia can assist in prognostication and individualization of treatment~     planning with special focus on hypoxic regions by targeted radiation dose or regimen~     modulation; consideration of more intensive chemotherapy regimens; more aggressive and~     targeted surgical resection and closer short-term clinical and imaging follow-ups.~   "
45089|NCT02466815|"~     The purpose of this study is to assess the relative bioavailability of 2 prototype G-025~     tablets compared with the current G-018 tablet.~   "
45090|NCT02466802|"~     This is a phase 1 study of sildenafil in combination with regorafenib in patients with~     progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted~     for the dose escalation of the treatment combination: additional patients will be enrolled~     at the MTD until a total of 12 patients have been treated at the MTD.~   "
45091|NCT02466789|"~     The purpose of this study is to improve the investigators ability to diagnose von Willebrand~     Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening~     blood test used to determine if a person has VWD. This new screening blood test can~     determine a diagnosis more rapidly than current blood tests. Also this test could be~     available at local hospital labs rather than require samples to be sent to bigger more~     specialized labs.~   "
45092|NCT02466776|"~     The purpose of this study is to determine the optimal skin closure technique (staples versus~     subcuticular suture) at the time of cesarean delivery in Class III obese women with body~     mass index (BMI) of >/= 40kg/m2.~   "
45093|NCT02466763|"~     In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear~     implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved~     for children. Since then, this procedure has become the standard of care for patients with~     severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on~     extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI~     team. Significant predictive factors for hearing outcomes in patients with CIs have been~     previously reported. These include, but are not limited to, duration of deafness, level of~     preimplant speech recognition, pre/postlingual status, and the coupling of device~     electrodes. Recipient age does not appear to have a significant impact on hearing outcomes~     in elderly candidates.~      Earlier studies have found that, because of its dimensions and proximity to the spiral~     ganglion cells, the scala tympani (ST) is the preferred location for CI electrode placement.~     A number of recent studies have proposed that intraoperative factors may be important~     determinants of electrode location and possibly of audiological outcome. Preliminary reports~     suggest that intracochlear electrode position- specifically, placement within the ST-is~     associated with improved audiological outcomes. Additionally, different surgical techniques~     have been proposed to minimize trauma during electrode insertion and to increase the~     likelihood of placement within the ST - namely round window and anteroinferior cochleostomy~     electrode insertion.~      Currently, the best surgical approach for electrode insertion is highly debated, fueled by a~     lack of strong evidence to support one method over another. While a number of CI centers~     have begun to utilize a round window approach, many large volume centers in the United~     States and world wide continue to routinely employ cochleostomy electrode insertions. With~     an increasing number of patients being implanted with greater degrees of residual hearing,~     such data will become critical towards reducing intracochlear injury and optimizing patient~     outcomes. To the investigators' knowledge, no clinical study has prospectively investigated~     the relationship between surgical insertion technique, intracochlear electrode location, and~     postoperative hearing outcomes. To this end, the investigators are initiating a multicenter~     prospective randomized controlled double-blinded study comparing round window and~     cochleostomy cochlear implant electrode insertion.~   "
45094|NCT02466750|"~     This study is being conducted to collect safety and immunogenicity data for the WEE vaccine,~     TSI-GSD 210. Enrollment in this protocol is offered for personnel who enter areas where this~     virus is used in research or is endemic (an area where this disease process is found to~     occur frequently).~   "
45095|NCT02466737|"~     Although there is no doubt that the presence of lymph node metastases worsens prognosis of a~     patient, unambiguous evidence to support lymph node dissection is still lacking. For many~     solid tumors, the role of lymph node dissection is yet controversial, and may depend on the~     tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast~     cancer is now considered as staging procedure that does not seem to influence breast cancer~     mortality. Women with breast cancer have benefitted greatly from a series of carefully~     performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA~     is to show that less axillary surgery is better, in that oncological outcomes are the same~     and less surgical intervention will result in fewer surgical complications.~   "
45096|NCT02466724|"~     Colorectal cancer (CRC) is a common and life threatening condition that will affect one in~     thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal~     malignancies or precancerous lesions at an earlier stage, which affords an opportunity for~     cure. However, low level of bowel cleanliness hinders polyp detection and therefore can~     limit colonoscopy effectiveness. Historically, the majority of the studies have focused on~     pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological~     factors have been found to have significant increases in bowel preparation quality. The~     purpose of this study is to evaluate the effectiveness of web-based instructions vs. the~     historical phone/letter instructions given to patients planning to have a colonoscopy.~   "
45097|NCT02466711|"~     The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric~     volume, motor and sensory effects in healthy patients.~   "
45098|NCT02466698|"~     Clostridium Difficile infections (CDIs) are treated initially with antibiotic therapy and~     supportive care, with surgical intervention reserved for patients with significant systemic~     toxicity or perforation. Severe CDI may be refractory to medical management and require~     surgical intervention, carrying a mortality of approximately 40%.~      Mortality associated with CDI increases significantly as the severity of the infection~     increases. In patients failing medical management, earlier operation is associated with~     decreased mortality. However, the lack of validated tools to predict the necessity for~     surgical intervention, combined with the significant morbidity associated with total~     colectomy significantly reduces the likelihood of patients receiving early surgical~     intervention. The purpose of the proposed study is to assess the addition of intestinal PEG~     lavage via nasojejunal tube to usual care in the treatment of adult patients with severe CDI~     who have no immediate indication for surgical intervention.~   "
45099|NCT02466685|"~     The goals of this study are to evaluate the efficacy of JNJ-18038683 in an 8 week trial to~     ameliorate the cognitive deficit and reduce residual depressive symptoms in 60 stable~     bipolar outpatients receiving treatment for depression. JNJ-18038683 will be studied and~     compared with placebo as adjunctive treatment to standard pharmacologic treatment for~     bipolar disorder.~   "
45100|NCT02466672|"~     This study will measure the effect of anemia on the outcomes of hospitalized children with~     severe pneumonia.~   "
45101|NCT02466659|"~     To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among~     patients aged 3 to < 11 years old.~   "
45102|NCT02466646|"~     The purpose of this study is to determine whether full-mouth disinfection is effective in~     the initial periodontal treatment of generalized aggressive periodontitis on clinical~     parameters and gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17)~     levels compared with conventional initial periodontal treatment and full-mouth initial~     periodontal treatment.~      The investigators' hypothesis is to test whether full-mouth disinfection in the initial~     periodontal treatment of generalized aggressive periodontitis enhance the clinical and~     biochemical parameters in comparison to conventional initial periodontal treatment and~     full-mouth initial periodontal treatment.~   "
45103|NCT02466633|"~     To increase the potential for timely detection and treatment of cardiac events, hospitals~     have implemented a number of different cardio-respiratory monitoring methods for at-risk~     patients. The goal of this study is to compare different monitoring methods to determine the~     most efficient method to monitor hospitalized patients - the method that will lead to the~     quickest response to critical heart rhythms. The investigators will then test the efficiency~     of this monitoring method by implementing it in a new patient care unit.~   "
45104|NCT02466620|"~     The purpose of this study is to study the validity, reliability and practicality of the~     different weight estimation methods (parent estimation method, Mercy method, Broselow tape,~     original and update APLS) in Thai children.~   "
45105|NCT02466607|"~     The electroretinogram (ERG) is a diagnostic test that measures the electrical activity~     generated by cells in the retina in response to a light stimulus. Typically, an ERG is~     recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device~     (RETeval) generates an array of color flashes, which allows studying whether color flash~     would be a useful diagnostic tool.~      Full pupil dilation is required to obtain a response from the whole retina. However, this~     requirement often limits a patient's flow in the clinic and increases the overall time~     patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs~     in un-dilated pupils therefore making the whole exam easier and shorter. These results need~     to be compared to the classic, fully dilated ERG and evaluated for efficiency.~      The purpose of this research study is to use the RETeval device to measure the eye's~     electrical response and how it changes with different stimuli such as changing flash color~     or pupil dilation.~   "
45106|NCT02466594|"~     This study evaluates the impact of active thermoregulation on free flap microcirculation~     following free flap transfer. Thermoregulation is performed by passive warming, active~     warming (water circulation based device) and active cooling. Changes in microcirculation are~     assessed using combined laser Doppler flowmetry and remission spectroscopy.~   "
45107|NCT02466581|"~     This is an international (Nordic) trial designed to compare the safety and efficacy of~     active conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol,~     Abatacept or Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim~     of this study is to assess and compare two alternative de-escalation strategies in patients~     who achieved low disease activity during first-line therapy in the NORD-STAR study.~   "
45108|NCT02466568|"~     The purpose of this study is to find out what effects (good and bad) a tumor vaccine~     (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer.~     Another purpose of the study is to find out the maximum tolerated dose of nivolumab in~     combination with GM.CD40L vaccine. Investigators also want to find out if the combination of~     GM.CD40L and nivolumab can boost the immune system of participants like you, and how their~     immune system reacts, both before and after the treatment.~   "
45123|NCT02466373|"~     This study is developed for assessing the pharmacodynamic and pharmacokinetic properties of~     intravenous (IV) clonidine in critically ill patients on the ICU, and to estimate the~     optimal dosing strategy for IV clonidine.~   "
48708|NCT02419521|"~     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx~     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native~     coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.~   "
45109|NCT02466555|"~     The purpose of this study is to investigate the effects of the BEATS Music Therapy Program~     on the self-efficacy, trust, knowledge, and adherence of young adult patients with sickle~     cell disease during transition.~      Primary Hypotheses:~      Compared to baseline, young adult patients with sickle cell disease who receive the music~     therapy interventions will report:~        1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale~          (SCSES),~        2. Higher trust in health care providers as measured by the Wake Forest Trust in the~          Medical Profession Scale, and~        3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge~          Quiz.~      Secondary Hypotheses~      1. Compared to the one year prior to the study period, young adults with sickle cell disease~     who receive the music therapy interventions will have a higher rate of adherence to clinic~     appointments during the one-year study period.~      Additional Questions~        1. Do music therapy interventions influence attendance to scheduled blood transfusions?~        2. Do music therapy interventions influence the rate of hospital utilization as measured~          by Emergency Department visits, Acute Care Clinic visits, and admissions during the~          study period compared to the previous year?~        3. Do music therapy interventions influence adherence to hydroxyurea therapy for patients~          receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the~          study period?~        4. Do music therapy interventions influence adherence to iron chelation therapy for~          patients receiving iron chelation therapy as measured by ferritin count during the~          study period?~   "
45110|NCT02466542|"~     This study aims to compare the quality of perioperative analgesia of esmolol in patients~     undergoing mastectomy.~   "
45111|NCT02466529|"~     Spinal muscular atrophy (SMA) is an autosomal recessive disorder characterized by~     degeneration of motor neurons in the spinal cord and caused by mutations of the survival~     motor neuron 1 gene (SMN1).~      The investigators will conduct a systematic review of the contents and activities collected~     via a comprehensive case report form. Patients who fulfilled diagnostic criteria for SMA~     type 1 will be reviewed retrospectively.~   "
45112|NCT02466516|"~     This study will evaluate the safety and tolerability of GS-4997 alone or in combination with~     Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages~     F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.~   "
45113|NCT02466503|"~     The objective of this pivotal study is to evaluate the relative bioavailability of~     Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with~     charcoal block.~   "
45114|NCT02466490|"~     Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration,~     currently approved for the treatment of essential hypertension in Corea and Mexico. As the~     safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to~     address the potential for ethnic factors to have an effect on the drug´s efficacy and safety~     in the Mexican population. To address this need, a cohort of 272 Mexican subjects with~     grades 1-2 essential hypertension were sequentially treated on a treat to target basis~     (target: sitting Diastolic Blood Pressure (sDBP) <90 mmHg) with 60 mg FMS once a day (8~     weeks), either 120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment~     period) and 120 mg FMS once a day (during 12 weeks) for a total treatment period of 24~     weeks.~   "
45115|NCT02466477|"~     Evidence exists supporting the ability of genetic variations to influence patient drug~     response and side effects. Previous studies utilizing an open-label design have shown~     significant improvement in major depressive disorder (MDD) patient outcomes following use of~     the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a~     double-blinded, randomized clinical trial design to replicate previous findings of~     improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN~     testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN)~     compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this~     trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian~     healthcare payers.~   "
45116|NCT02466464|"~     The purpose of this study is to compare a new treatment for nosebleeds to the treatment that~     has been used for many years.~   "
45117|NCT02466451|"~     Observational longitudinal study in children operated at birth on diaphragmatic hernia~     and/or oesophageal atresia : assessment of lung function parameters; assessment of quality~     of life and cognitive development; assessment of stress parenting and strategies of~     adaptation.~   "
45118|NCT02466438|"~     Severe infection is one of the main causes of disease in hospitalized children and can be~     deadly. With the lack of novel antibiotics approved in children and the emergence of drug~     resistant bacteria, there is a critical need to optimize dosing of existing antibiotics.~     Piperacillin-tazobactam is an antibiotic frequently used for treatment of severe infection~     in children in Canadian hospitals. To optimize this antibiotic's efficacy despite the rise~     of antibiotic resistance, alternative dosing strategy is commonly used in adults, which~     consists of prolonging the time during which the drug is infused (4 hours instead of 30~     min). Children clear piperacillin-tazobactam from their bodies at a slower rate than adults,~     consequently extended-infusion strategy cannot be directly extrapolated from adult to~     children. We believe that younger children need piperacillin-tazobactam infusions that are~     shorter compared to adults to achieve appropriate concentrations.~   "
45119|NCT02466425|"~     The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD~     in children and adolescents (aged 6-17 years). The primary objective of this study is to~     evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in~     the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.~   "
45120|NCT02466412|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK)~     profiles of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon~     Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) compared to menthol conventional cigarette~     (mCC) in healthy smokers.~   "
45121|NCT02466399|"~     This is an open-label, randomized, multi-center, active-controlled parallel-comparison of~     POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and~     primary open-angle glaucoma.~   "
46702|NCT02445729|"~     The purpose of this study is to determine if surgical dressings removed at 24 hours or 48~     hours improves wound healing and appearance, and to determine if surgical dressings removed~     after 24 hours or 48 hours decreases the incidence of post-operative wound infections.~   "
45124|NCT02466360|"~     Non-specific chronic lower back pain is a common pathology which is a real public health~     problem. Around 84% of the population could have non-specific chronic lower back pain at~     least once in their lives and 8% of that non-specific lower back pain could become chronical~     (pain that would last at least 3 months). This proportion of patients represents 85% of the~     costs related to this pathology.~      Physical activity practice is involved in medical care for plenty of chronical diseases and~     particularly for chronic lower back pain. In 2003, World Health Organization pointed out the~     poor adhesion of patients with chronical diseases to medical prescriptions and the~     after-effects it could have on illness evolution. Therefore, adhesion to physical activity~     practice for patients with chronic lower back pain is one of the most challenging matters~     for medical teams.~      The aim of this study was to identify the brakes and levers of physical activity practice~     for these patients. Sixteen individual interviews and four focus groups have been carried~     out on patients with chronic lower back pain who were taken care of either by a rachis~     functional restoration program or by primary care.~   "
45125|NCT02466347|"~     The objective of this pivotal study is to evaluate the relative bioavailability of~     Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without~     charcoal block.~   "
45126|NCT02466334|"~     It has previously been shown that nitroglycerine induces cluster headache attacks in~     episodic cluster headache patients (ECH patients) in bouts but not in remission phase.~     Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown~     to be significantly higher during, but not before and after, an attack.~      The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation.~     During this latency period preceding the attack, no increase in CGRP plasma concentrations~     is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as~     well as monoclonal antibodies against CGRP are effective in migraine treatment.~      Based on the above the investigators hypothesize the following:~        1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks~        2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks~        3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks~          more often than in ECH patients.~   "
45127|NCT02466321|"~     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™~     Inverse/Reverse System by analysis of standard scoring systems and radiographs.~      Outcome data will be collected using the following standard scoring systems of which summary~     statistics will be provided:~        -  Constant and Murley Score to evaluate clinical parameters such as range of motion,~          power, level of pain and functional ability.~        -  SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of~          twelve questions to assess the subject's physical and mental health status which must~          be answered by the patient.~   "
45128|NCT02466308|"~     ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a~     portable and wearable medical device which, when applied to various areas of the body~     applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is~     FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and~     increasing local circulation. This study will look at the use of therapeutic ultrasound to~     relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6~     week time period.~   "
45129|NCT02466295|"~     The purpose of this study is to investigate whether the pressure controlled ventilation can~     reduce gastric insufflation compared to the volume controlled ventilation in patients who~     were mechanically ventilated with the i-gel.~   "
45130|NCT02466282|"~     It is well-known that non-optimal stent implantation associated with under-expansion or~     incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a~     higher incidence of restenosis and stent thrombosis. OCT-guided PCI with metallic stent has~     previously been shown to be safe and feasible, resulting in better clinical outcomes~     compared with angiography-only guided PCI. Everolimus-eluting bioabsorbable vascular~     scaffold (BVS; Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable~     polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer~     that contains and controls the release of the antiproliferative drug, everolimus. BVS has a~     number of proposed advantages over current metallic stent technology. These include~     elimination of chronic sources of vessel irritation and inflammation, which can reduce the~     potential risk of late scaffold thrombosis after complete scaffold bioresorption. Although~     the current generation of the Absorb BVS have larger strut thickness of 150 μm compared with~     80 μm of strut of Xience stent, the acute recoil of the polymeric device was similar to that~     of metallic stent. However, operators tented to use dilating devices less aggressively~     because of the concerns about limitation in elongation-at-break of polylactide. Previous~     studies reported 20-30% of under-expansion or malapposition with BVS, which would increase~     the risk of adverse events including late stent thrombosis. OCT-guidance may improve more~     optimized scaffold placement and also better outcomes. Therefore, investigators will compare~     OCT guidance and angiography-only guidance for PCI with BVS regarding incomplete scaffold~     apposition and neointimal scaffold coverage. Investigators are also going to compare these~     two strategies regarding clinical outcomes with verification of the cut-off value by~     OCT-acquired uncovered scaffold rate.~   "
45131|NCT02466269|"~     A new surgical approach, denoted as the supratemporalis approach, was designed to treat~     diacapitular condylar fractures of the mandibular condyle.This approach prevented facial~     nerve injury and did not increase the frequency of other complications. Therefore, the~     investigators suggest this surgical procedure as a routine and safe approach to diacapitular~     condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the~     zygomatic arch.~   "
45132|NCT02466256|"~     This randomized clinical trial compares subjective performance during Intraocular lens (IOL)~     implantation, as well as incision enlargement and anterior segment morphology on OCT when~     IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm~     incision using one of three injectors :~      Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector~     (Autosert). Further, the investigators also looked at incision integrity by comparing~     ingress of trypan blue from the ocular surface into the anterior chamber.~   "
45133|NCT02466243|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in~     adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3~     months treatment with hydroxychloroquine.~   "
45178|NCT02465658|"~     The presence of co-existence of cervical elongation in women of uterine prolapse may~     decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse,~     and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus~     the aim of this study is to investigate the risk factors of co-existence of cervical~     elongation in uterine prolapse.~   "
45134|NCT02466230|"~     This study utilizes resting state fMRI, arterial spin labelling imaging, diffusion tensor~     imaging, structural MR-imaging, and MR-spectroscopy of GABA and Glutamate to probe the~     antidepressant mechanisms of repetitive transcranial magnetic stimulation (rTMS). The above~     imaging modalities will be acquired before and after an open-label 5 week course of rTMS for~     depression in currently depressed individuals with treatment resistant depression. Changes~     in functional, structural, and neurochemical markers will be investigated in rTMS responders~     and nonresponders to elucidate mechanisms of plasticity that correlate with treatment~     response. Additionally, functional, structural, and neurochemical signatures at baseline~     that correlate with subsequent treatment response will be investigated.~   "
45135|NCT02466217|"~     The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure~     inflammatory diseases to pure autoimmune diseases, encompassing a large panel of~     inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of~     patients with IAD should be heuristic and help revise the nosography and the understanding~     of these diseases.~   "
45136|NCT02466204|"~     A prospective, randomized, controlled study to explore the efficacy and safety of using~     either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH)~     300 international unit (IU) for the stimulation treatment of subjects undergoing controlled~     ovarian stimulation prior to IVF.~      The study is designed as a non-inferiority trial. The sample size for this trial of 400~     subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint~     of the number of oocytes retrieved.~   "
45137|NCT02466191|"~     Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting~     quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple~     sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on~     pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been~     thoroughly proposed over different publications of cases, series, reviews or expert~     opinions. Acquired pendular nystagmus underwent the most rigorous treatment trials, leading~     to the proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and~     memantine are effective in APN associated with OPT remains unclear, since none of the~     previous studies has evaluated the effect of these medications in a group of OPT patients.~     However, this is an important issue in prospect to a clinical use of these medications. In~     the current study, the investigators aim is to evaluate the effect of gabapentin and~     memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on~     visual acuity and vision-specific health-related quality of life score, in a group of OPT~     patients~   "
45138|NCT02466178|"~     The purpose of this study is to evaluate the ability of the Serene RF System to effectively~     improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3~     months.~   "
45139|NCT02466165|"~     Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in~     young adults. Due to heterogeneous symptoms, MS patients are often more inactive than~     healthy controls, resulting in an inactivity related physiological profile. In healthy~     people, physical inactivity can contribute to the development of an increased~     cardiometabolic risk state including the combined presence of cardiovascular risk factors~     (increased cholesterol, elevated blood pressure, body fat, glucose intolerance/insulin~     resistance, inflammation and reduced heart function/autonomic control). In other~     populations, these secondary health complications can be, in part, reduced by physical~     exercise, which is often used as the primary treatment strategy. Since the impact of~     exercise on cardiovascular risk factors in MS is unknown the present project first aims to~     explore this, in a controlled research setting (during 12 weeks). A better understanding of~     the above described risk factors and underlying physiological mechanisms will reduce the~     incidence of preventable comorbidities in MS and will further improve the multidisciplinary~     treatment of MS patients and MS rehabilitation in particular. Interestingly, the~     investigators already reported an elevated prevalence of impaired glucose tolerance in MS,~     but it is not clear whether the cardiometabolic state in MS is also impaired. Therefore, in~     a second part, the researchers will explore whether MS patients present a higher risk to~     develop cardiovascular diseases, as measured by the assessment of various cardiovascular~     risk factors, compared to healthy controls.~   "
45140|NCT02466152|"~     This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512~     following twice daily topical administration of 1% and 2% cream in adult subjects with AD,~     and will provide information about the systemic safety as well as local safety and~     tolerability following twice daily application to up to 35% body surface area (BSA) of~     affected skin of subjects with AD. It will be an open-label, sequential study consisting of~     2 cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected~     skin on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day~     21. Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the~     same procedures as Cohort 1.~   "
45141|NCT02466139|"~     The investigators conduct a prospective observational study on consecutive patients being~     admitted to a tertiary care-centre with infective endocarditis. The investigators' primary~     aim is to identify baseline clincal, laboratory and microbiological predictors of~     in-hospital events, mortality and 6-month mortality.~   "
45142|NCT02466126|"~     The purpose of this study is to determine the effectiveness of a brief cognitive behavioral~     therapy (bCBT) intervention for Veterans with depression delivered by mental health~     providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the~     Houston and Oklahoma City VAMCs.~   "
45143|NCT02466113|"~     Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is~     still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool~     consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that~     was effective to identify one should accept adjuvant chemotherapy or not. Here investigators~     randomly assign patients to be assessed by classical pathological features or the miRNA tool~     of determining who should accept chemotherapy. Disease free survival and overall survival~     are the end points of observation.~   "
45179|NCT02465645|"~     After successful screening of patients based on inclusion criteria, we will measure the~     baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood~     investigation including complete haemogram, kidney function test, liver function test,~     prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan.~     Routine complete physical examination will be done.~   "
45144|NCT02466100|"~     This study proposes to evaluate, among adults with advanced heart failure (HF) and their~     health care providers, the effects of a communication intervention designed to improve~     patient-provider communication about goals of care (GoC). Patient activated GoC~     conversations can result in providers' better understanding their patients' preferences for~     end-of-life care. GoC conversations that occur over time may allow patients and providers to~     consider a wider range of options earlier in the HF illness trajectory. Preliminary data~     suggests that the proposed GoC intervention increases the occurrence and quality of~     patient-provider communication about end-of-life care for advanced COPD. The proposed study~     will test the effects of the GoC intervention compared to usual care, using a randomized,~     2-group (N = 80, n = 40/arm), repeated-measures design. Measures will be taken at a~     patient's baseline study entry and after the next scheduled clinic visit. Specific Aim 1 is~     to evaluate change in number of GoC conversations between patient and provider between the~     two groups. Specific Aim 2 is to examine whether the intervention increases patient quality~     of life, referrals to palliative care, advance care planning, decreases depression and~     anxiety. Specific Aim 3 is to describe the feasibility, acceptability, perceived benefits,~     burden, and implementation success of the intervention in the heart failure clinic setting.~     Patients will be randomized to the GoC intervention or to receive usual care. Patients in~     the GoC intervention group, telephone coaching by a research nurse to help patients~     role-play talking with their HF providers. Both patients and their providers, will be~     provided with summaries of individualized, patient-centered information about patient~     preferences for communicating about end-of-life care and patient self-identified barriers to~     and facilitators of communication about end-of-life care with tips on how to initiate goals~     of care discussions. Providers of patients in the intervention group will also be provided~     with patient-specific prognostic information based on the Seattle Heart Failure Model. The~     GoC intervention will be tested in a real-world clinic setting. This intervention is~     expected to be relatively cost-effective and easily translated into general cardiology~     practice in the future. The study is expected to make significant contributions to provision~     of earlier access to palliative care in the advanced HF disease trajectory.~   "
45145|NCT02466087|"~     The objective of this project is to test the hypothesis that magnesium supplementation will~     decrease depressive symptoms in adults.~      This study takes place over 12 consecutive weeks. While the investigators will follow the~     volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6~     consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or~     week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental~     magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the~     tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will~     be asked to maintain their normal diet for the 12 weeks of the study.~      The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression.~     Secondary measures include the GAD-7 for Anxiety and side effects.~   "
45146|NCT02466074|"~     This study will evaluate how improved cerebral blood flow affects the way in which newly~     formed MS lesions evolve into black holes. Patients with multiple sclerosis (MS) will be~     treated with acetazolamide at different doses and obtain MRI to determine how much and in~     which regions of the brain cerebral perfusion improves.~   "
45147|NCT02466061|"~     This randomized, controlled study evaluates the efficacy of weigh loss interventions in~     endometrial cancer survivors, using novel technology-based weight loss platforms. This is a~     multi-site, pilot feasibility study which will provide preliminary data to support a larger~     NIH funded, mult-center trial.~   "
45148|NCT02466048|"~     This study was designed to investigate the safety and efficacy of SurgiFill™, a bone~     grafting material, in patients with spinal fusion.~   "
45149|NCT02466035|"~     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic~     disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk~     allergy. The mechanisms of these effects are still largely undefined. The effect of LGG~     could be related at least in part by the immunoregulatory role played by LGG. This probiotic~     can balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's~     milk allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can~     contribute to modulation of inﬂammatory processes. The investigators have demonstrated that~     children with IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in~     response to cow's milk protein, and that tolerance is associated with a marked reduction of~     IL-13 production and a concomitant increased frequency of IFN-γ releasing cells.~      Epigenetics studies the heritable (and potentially reversible) changes of the genome~     inherited from one cell generation to the next which alter gene expression but do not~     involve changes in primary DNA sequences, highlighting the complexity of the~     inter-relationship between genetics and nutrition. There are three distinct, but closely~     interacting, epigenetic mechanisms (histone acetylation, DNA methylation, and non-coding~     microRNAs) that are responsible for modifying the expression of critical genes associated~     with physiologic and pathologic processes. The profile of epigenetic modifications~     associated with Th lineage commitment, coupled with the sensitivity of the early~     developmental period, has led to speculation that factors that disrupt these pathways may~     increase the risk of allergic diseases. Specifically, effects on DNA methylation and~     endogenous histone deacetylase inhibitors acting on specific pathways (Th1 and T regulatory~     cell differentiation) may favour Th2-associated allergic differentiation. MicroRNAs are~     another structural components of an epigenetic mechanism of post-transcriptional regulation~     of messenger RNA translation. It has been recently identified a specific Th2-associated~     microRNA (miR-21) that is critical for the regulation of Th cell polarization. It has been~     previously demonstrated an inverse DNA methylation pattern of cytokines involved in Th2~     response (IL-4, IL-5) compared with cytokines involved in Th1 response (IL-10, INF- y) in~     children with CMA acquiring oral tolerance, with the most pronounced effects in those~     treated with Nutramigen LGG. The current study will prospectively evaluate the effect of~     Nutramigen LGG and other commercially available hypoallergenic formulas on epigenetic~     mechanisms that may be related to tolerance acquisition.~   "
45150|NCT02466022|"~     Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control,~     with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine~     has been used with a large loading dose and infusion, which has been known to cause~     dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine~     produces less negative side-effects, but still effective sedation and reduced post-operative~     pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but~     only a few studies exist investigating its benefits when administered for sedation purposes~     with spinal anesthesia, and no studies primarily examine post-operative opioid consumption.~     The investigators hypothesize that single dose dexmedetomidine for procedural sedation will~     reduce opioid consumption after total knee arthroplasty (TKA).~   "
45151|NCT02466009|"~     The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to~     monitor the impact of treatment with regorafenib on the quality of life in older adults with~     metastatic colorectal cancer.~   "
45152|NCT02465996|"~     Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be~     helpful to improve the symptoms of FD.~   "
45153|NCT02465983|"~     This is a study in which pancreatic cancer patients receive a combination therapy with~     CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide.~     CART-meso cells are patients' own T cells that were modified in the laboratory to express a~     receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that~     were modified in the laboratory to express a receptor specific to a protein called CD19. The~     CD19 protein is expressed on white blood B cells. CART19 cells are expected to attack the B~     cells and impede the antibody response against CART-meso cells. The investigators~     hypothesize that this combination therapy may prolong the duration of CART-meso cells in the~     body. Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of~     CART cells.~   "
45154|NCT02465970|"~     Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life~     expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery.~     Neurostimulation, which can be an effective add-on treatment, is currently mainly~     represented by vagus nervus stimulation. Transcranial direct current stimulation, a non~     -invasive technique already used in other areas of neurology, may be efficient on some~     partial epilepsies, in particular through the individual configuration of stimulation, made~     possible by recent technological advances.~      Main goal : To study the effect of transcranial electrical stimulation on the frequency of~     seizures in patients with drug-resistant partial epilepsy.~      Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24~     hours following an individually configured TDCS session: responders in real TDCS vs placebo~     stimulation.~   "
45155|NCT02465957|"~     Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with~     Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC).~   "
45156|NCT02465944|"~     This study will be conducted to evaluate the safety, tolerability and efficacy of~     intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with~     moderate to severely active Crohn's Disease~   "
45157|NCT02465931|"~     The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the~     Eunice Kennedy Shriver National Institute of Child Health & Human Development,~     1R01HD071987-01A1, and will provide the first comprehensive description of decisional~     capacity of individuals with FXS; identify individual, family, and experiential factors~     associated with variability in decisional capacity; determine the validity of caregiver and~     expert ratings; and develop evidence-based guidelines for categorizing decisional capacity~     of individuals with FXS. RTI will develop a methodologically rigorous and conceptually~     grounded decision aid using digital technology to enhance participation of individuals with~     FXS in the consent process.~   "
45158|NCT02465918|"~     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic~     pain not responsive to medication. An electrode is placed on the surface of the brain and~     connected to a programmable battery in the chest.~      The strength of stimulation can be individually adjusted by changing the voltage of~     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low~     voltage will not provide pain control.~      The aim of this study is to analyze the optimal stimulation timing parameters in patients~     already implanted with MCS and have received good pain relief. The investigators wish to~     cyclize on/off MCS in order to save the battery life of the stimulator and also decrease~     stimulus habituation. The investigators hope to determine these timing parameters while~     maintaining optimal pain relief.~   "
45159|NCT02465905|"~     Prospective study Main objective: to evaluate the efficiency and the security of two~     protocols of immunotherapy (raw milk versus heated milk) in a cohort of children with~     persistent Immunoglobulin E (IgE) mediated CMA (IgE-CMA).~      Secondary objectives: to determinate if the enumeration of casein-specific IL-4- and~     IL-13-secreting T cells could be a valuable biomarker of successful immunotherapy.~   "
45160|NCT02465892|"~     This study aims to explore whether cancer patients can benefit from completing the~     Pillars4Life online coping program. This randomized control trial will have half its subject~     completing the program and the other half receiving standard care in order to measure~     whether the program is beneficial in dealing with stress, anxiety, and particularly chronic~     pain that often accompany a cancer diagnosis.~   "
45161|NCT02465879|"~     There is accumulating evidence that early treatment leads to better outcomes for patients~     with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of~     a patient's disease state efficiently and correctly, may facilitate early referral to a~     rheumatologist. Several studies have suggested that placing allied health professionals~     (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce~     wait time for patients with suspected IA. The goal of this investigation will be to~     demonstrate the system-level impact of an Arthritis Society extended role occupational~     therapist (OT) or physical therapist (PT) working in a triage role in improving access to~     rheumatologists for people with IA. In this study two groups will be observed: intervention~     and usual care as determined by historical chart review. Wait times will be compared~     between both groups.~   "
45162|NCT02465866|"~     This study will compare the relative bioavailability of hydrocodone, acetaminophen, and~     promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg)~     manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5~     mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl~     37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.~   "
45163|NCT02465853|"~     Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede~     rehabilitation programs and the motor recovery of affected upper extremity. HSP was~     associated with impaired daily life activities and prolong hospital stay after stroke.~     Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs~     injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff~     injuries. Previous researchers reported that HA could provide pain relief, improved motion,~     and increased daily activities. In this study, fifty subacute stoke patients will be~     enrolled. These patients will be allocated into group A and B randomly. The patients in~     group A received HA injection while patients in group B received normal saline injection.~     Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All~     the patients will still receive rehabilitation programs of physical therapy and occupational~     therapy. Each patient will receive physical, sonographic examinations, and stroke Specific~     Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA~     injection on pain relief, motor function recovery, and life quality in subacute stroke~     patients with HSP before and after HA injection.~   "
45180|NCT02465632|"~     This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,~     designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5%~     topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel,~     Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne~     vulgaris.~   "
48709|NCT02419508|"~     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering~     effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a PGA~     in patients with open-angle glaucoma or ocular hypertension.~   "
45164|NCT02465840|"~     Hand injury is one of common occupational or traumatic injury at outpatient clinic of~     rehabilitation department. The motor or sensory deficits after hand trauma including bony~     fracture,tendon / nerve injury, joint stiffness, motion restriction, sensory impairment, or~     pain lead to impaired upper extremity function, ability for daily activity, or quality of~     life. Rehabilitation is a kind of therapy for disability after hand trauma. It could provide~     pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma.~     The investigators consider that there are some deficits in hand function and range of~     motion, pain after injury, and some attenuation of brain functional MRI (fMRI) for hand~     motor control. Therefore, optimal and early intervention of rehabilitation programs may have~     some benefits for their hand functional outcome and improve the brain activities in fMRI~     images for the hand motor control.~      The aims of this study are to compare the differences in hand motor control area of brain~     functional MRI (fMRI) between normal subjects and hand injury patients before treatment and~     to investigate the improvement in brain fMRI activity and functional outcome after early~     rehabilitation in hand injury patients.~      The investigators will collect 40 patients with hand trauma after operation and 10 normal~     subjects in this study. The 10 normal subjects were allocated in the control group. These 40~     patients were randomly divided into 2 experimental groups: 20 patients in group A and 20~     patients in group B.~      In group A and B, the patients will perform immobilization and Kleinert programs~     respectively. All patients will perform rehabilitation regimen with 2-3 sessions per week~     for 3-6 months. Before and after rehabilitation, all patients will receive physical~     examinations, brain fMRI, and DASH questionnaire for daily activity.~   "
45165|NCT02465827|"~     The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided~     blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours~     post-operatively for patients undergoing unilateral primary total knee arthroplasty.~   "
45166|NCT02465814|"~     The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with~     uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety~     of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic~     (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids~     will be supplemented.~   "
45167|NCT02465801|"~     The purpose of this study is to evaluate the dosages of recombinant human serum~     albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing~     neutrophilic granulocytopenia among chemotherapy patients.~      Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte~     colony-stimulating factor fusion protein with recombinant human granulocyte~     colony-stimulating factor injection as a control.~   "
45168|NCT02465788|"~     The objective of this post marketing study is to further explore a variety of treatment~     parameters in order to optimize the optical (laser) and electrical (RF) treatments over the~     various skin types, when using a combination 755 nm alexandrite laser together with a~     bipolar RF energy system, for the purpose of hair reduction.~   "
45169|NCT02465775|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the~     performance of the UltraShape treatment for non-invasive fat reduction by compare control~     and treated flanks.~      Study subjects will undergo UltraShape treatments on one randomized flank using the~     U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks~     (treated and control) will be compared to baseline, as well as, one to each other~   "
45170|NCT02465762|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the~     UltraShape treatment for non-invasive fat and circumference reduction.~      Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF~     Transducer - 60 subjects.~   "
45171|NCT02465749|"~     The purpose of this study is to investigate the role of continuous oxygen therapy combined~     with blue light deprivation in prevention and control of retinitis pigmentosa, in order to~     find a new strategy of treatment for retinitis pigmentosa.~   "
45172|NCT02465736|"~     The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus~     cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and~     toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.~   "
45173|NCT02465723|"~     The purpose of this study is to find out if special blood tests and imaging scans can help~     evaluate the effects of the radiation the patient receives as part of standard treatment.~     The patient will undergo either stereotactic or conventional radiation treatment as~     determined by the treating doctor. Previous evidence suggests that blood flow to tumors is~     affected by the amount (dose) of radiation that it receives. This effect may be seen as soon~     as 1-2 hours after the radiation is given. This study will evaluate if these changes can be~     seen and measured by performing a special type of scan called Intravoxel Incoherent Motion~     (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a~     research exam which is similar to a standard MRI exam, with only a slight difference in the~     technical parameters used to acquire the images.~   "
45174|NCT02465710|"~     The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse~     remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women~     who underwent pelvic organ prolapse surgeries with and without mesh implantation in the~     Department of Obstetrics & Gynecology of National Taiwan University Hospital.~   "
45175|NCT02465697|"~     Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in~     approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has~     proven quite treatment resistant. This study is designed to determine whether patients with~     BPD can be trained to improve their ability to regulate their emotions and whether this~     leads to changes in how their brans regulate emotion.~   "
45176|NCT02465684|"~     There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet~     in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like~     operating time, blood loss, quality of prosthesis fixation in the bone, adverse events,~     radiographic result, clinical score outcome, easy of rehabilitation etc. It is not~     appropriate to rely on findings from the field of total knee arthroplasty.~      It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA~     with regard to component fixation quality, component positioning and sizing, clinical~     outcome and rehabilitation process.~      Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in~     the medial compartment will be considered for participation.~      Patients are then randomized for surgery with or without tourniquet. After an anteromedial~     Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the~     manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.~      The following outcome parameters are assessed: 1)radiographic cement mantle thickness,~     2)component position & sizing, 3)diolucencies, 4)score outcome and 5)parameters of early~     Rehab.~   "
45177|NCT02465671|"~     The current study was designed to investigate the change of plasma thrombospondin-1 levels~     and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the~     patients with acute intracerebral hemorrhage.~   "
45183|NCT02465593|"~     This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of~     PEP503(radio-enhancer).~      There are 2 portions in this study.~        -  Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in~          this phase to identify the recommended injection volume of PEP503 for intratumor~          injection.~        -  Expansion phase (Part II): Following the confirmation of the recommended volume of~          intratumor injection, 18 additional patients will be enrolled at the recommended volume~          level to evaluate for efficacy.~   "
45184|NCT02465580|"~     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,~     which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by~     the investigator's group, the investigators found that the Low-dose IL-2 was effective and~     well tolerated in active SLE, and the effect was associated with selective modulation of~     CD4+ T cell subsets.~      This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.~      The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The~     investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus~     erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N =~     30)).~   "
45185|NCT02465567|"~     This is a randomized, double-blind, multi-center, parallel-group study to assess the~     efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with~     moderate to very severe COPD.~   "
45186|NCT02465554|"~     The purpose of this study is to develop new approaches for screening astronauts for~     cardiovascular risk during deep space missions.~   "
45187|NCT02465541|"~     This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle~     change effects physical function and quality of life of endometrial cancer survivors. Gentle~     yoga and dietary counseling may help improve physical function and quality of life for stage~     I-II endometrial cancer survivors.~   "
45188|NCT02465528|"~     This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety~     and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that~     are characterized by ALK genetic alteration (and/or overexpression in some diseases).~   "
45189|NCT02465515|"~     Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes~     This study will test whether albiglutide affects the occurrence of major cardiovascular~     events such as heart attacks or strokes and other important medical outcomes in persons with~     type 2 diabetes, when used alone or added to other diabetes treatments.~   "
45190|NCT02465502|"~     To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks)~     of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is~     refractory to standard therapies and who were never exposed to antiangiogenic therapy.~   "
45191|NCT02465489|"~     The purpose of this study is to look at the pharmacokinetics of a new formulation of~     deferiprone (deferiprone extended release tablets) under fed and fasting conditions.~   "
45192|NCT02465476|"~     The investigators want to demonstrate that a new organization with telemedicine could~     rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis~     and a personalised treatment pathway could be performed before the consultation in the~     hospital.~   "
45193|NCT02465463|"~     Clostridium difficile infection (CDI) has increased worldwide in both frequency and~     severity. It is the leading cause of hospital acquired infection in developed countries and~     has been associated with at least 14,000 deaths per year in the United States. With 3~     million cases/ year, the annual cost for treating the infection is exceeding 3 billion~     dollars. It can also have a profound negative impact on quality of life.~      The investigators believe that patients who are at high risk of relapse after a first CDI~     episode would benefit from early fecal microbial transplant (FMT). The proposed study will~     produce preliminary data regarding safety and efficacy and potential for cost effectiveness~     for the use of early fecal transplant in those patients with their first episode of~     non-refractory CDI who are predicted to have a high rate of recurrence based on previously~     published risk factors. The investigators will be better prepared to test the efficacy of~     this approach in a future multicenter clinical trial in a randomized controlled fashion.~      The purpose of this study is to compare the effectiveness and safety of early fecal~     transplant using donor stool from a healthy person in a group of patients who are diagnosed~     with their first episode of Clostridium difficile infection and are predicted to have a high~     chance of the infection returning against a similar group of patients who receive current~     standard of care for treatment of C.difficile.~      The investigators hypothesize:~        -  that clinical remission rates at 12 weeks as noted by absence of clinical symptoms~          and/or negative C.difficile stool polymerase chain reaction (PCR) will be greater in~          the experimental arm compared to the control arm~        -  that patients in the experimental group will have a low microbial diversity prior to~          FMT but will exhibit a high microbial diversity after the FMT that resembles the~          respective donor~        -  that the microbial diversity will be diminished in both groups at the time of~          enrollment, but the experimental group will exhibit a higher microbial diversity~          compared to the control population at 12 weeks~        -  that patients in both groups will exhibit poor quality of life at the time of~          enrollment, however, the experimental group will demonstrate higher quality of life~          compared to the control group at follow up after completion of treatment~        -  that costs incurred by the experimental group will be less than the control group~   "
45194|NCT02465450|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).~   "
45195|NCT02465437|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.~   "
45196|NCT02465424|"~     The purpose of this study is to determine which Health Related Quality of Life (HRQoL) tools~     patients with medullary thyroid cancer (MTC) find most helpful. The study will compare a~     generic cancer QoL tool with those developed for thyroid cancer patients and neuroendocrine~     tumour (NET) patients. The study will also evaluate clinicians' opinions on the clinical~     usefulness of the QoL tools.~   "
45197|NCT02465411|"~     A keystone in preventing diabetic complications in patients with type 1 diabetes is good~     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an~     essential part of insulin dosing before meals. However, in recent years continuous glucose~     monitoring (CGM) has become a treatment option to inform the patient when glucose levels may~     be too high or low.~      In some countries, including Sweden, CGM is reimbursed only when combined with continuous~     subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a~     history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on~     existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with~     CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated~     with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with~     type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the~     CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM~     over 6 months, followed by conventional therapy over six months, with a four-month wash-out~     period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality~     of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.~      From a research or regulatory standpoint, long-term data on treatment effects are expected~     to a greater extent today than in previous years, due to various reasons, e.g., to evaluate~     any sustained beneficial effects over time, or long-term patient safety. Accordingly,~     follow-up of treatment in an extension phase after randomized diabetes trials have become~     more common over time, especially where many novel glucose-lowering treatments are~     concerned. Therefore, the aim of the current study is to evaluate long-term effects of CGM~     in patients with type 1 diabetes treated with MDI. Patients who consent in an extension~     phase over 1 year of the CGMMDI trial will receive CGM, and evaluations will be performed on~     sustained glycaemic control effects, hypoglycaemia, glycaemic variability, quality of life,~     fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.~   "
45198|NCT02465398|"~     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture~     System by analysis of standard scoring systems and radiographs.~      Outcome data will be collected using the following standard scoring systems:~        -  Constant and Murley Score~        -  Oxford Shoulder Score~        -  EQ-5D (EuroQol)~   "
45199|NCT02465385|"~     Video capsule endoscopy is an important procedure that can be used by doctors to find~     abnormalities in the small intestine, especially those that can cause bleeding. The~     procedure uses a tiny wireless camera to take pictures of the digestive tract. The camera~     sits inside a vitamin-sized capsule that a person can swallow. As the capsule travels~     through the digestive tract, the camera takes thousands of pictures that are transmitted to~     a recorder worn on a belt around a person's waist or over his/her shoulder. However,~     abnormalities can be missed partly because the normal dark liquids present in the intestine~     can prevent abnormalities from being recorded, hiding them from the physician who reviews~     the video.~      The current method used to clear these dark liquids from your small intestine is to follow a~     clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the~     day before the video endoscopy and take simethicone (a medication used to treat symptoms of~     gas such as uncomfortable or painful pressure, fullness, and bloating) the morning of the~     test.~      Some of the current preparations to clear these dark liquids are not able to entirely~     prevent abnormalities from being missed and most have an unpleasant taste or involve~     drinking a lot of fluid.~      Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA)~     for the treatment of constipation and irritable bowel syndrome. It is not approved by the~     FDA for use as an aid for clearing dark liquid from the small intestine prior to a video~     endoscopy.~      A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®)~     to improve cleansing of the small intestine for capsule endoscopy preparation to supplement~     fasting and clear liquid diet.~      This report claimed a noticeably better quality of small intestine cleansing and a 20%~     shorter transit time for the capsule by taking one dose of linaclotide one hour before~     patients swallowed the video capsule.~      The purpose of this study is to assess the use of one dose of linaclotide in terms of the~     total time it takes the capsule to move through the small bowel, and image quality as~     compared to the current method. The results of this study will be compared to previous~     patients who drank the preparation that is currently used~   "
45200|NCT02465372|"~     The purpose of this project is to develop a Comprehensive School Physical Activity Program~     (CSPAP) training protocol, and test the feasibility, acceptability, and effectiveness of its~     delivery in an elementary school setting.~   "
45201|NCT02465359|"~     The investigators are using self administered subcutaneous IG in patients with CIDP who~     require IVIG. Safety, efficacy, and patient satisfaction will be examined.~   "
45202|NCT02465346|"~     Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety~     and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site~     for hyperacute treatment and transfer to the most appropriate target hospital. The effects~     on reduction delays until different stroke treatments will be assessed. First estimations of~     cost-effectiveness will also be performed.~   "
45203|NCT02465333|"~     Plantar heel pain is the most common problem of the foot. Plantar fasciitis is the leading~     cause of this pain, accounting for 11-15% of all foot symptoms seeking professional care,~     and occurs in 10% of the US population. The cause of heel pain can be from bone, soft~     tissue, nerve, or systemic disease. The second most common cause of heel pain is fat pad~     atrophy, followed by a combination of both fat pad atrophy and plantar fasciitis. [1-4] Fat~     pad displacement may be seen in the heel as well.~      Current treatments for plantar fasciitis include stretching and external support with~     orthotics with the goal of reducing local pressure as well as tissue breakdown.[5] However,~     patient compliance with extrinsic devices is challenging, and they may experience increased~     friction, irritation and breakdown at a different location on the foot due to thickness of~     the device in the shoe. Also, the patient must replace the device as soon as it breaks down~     but the breakdown often goes unnoticed. Failure of conservative management may lead to~     treatment with steroids or surgical intervention by endoscopic plantar fasciotomy, open~     fasciotomy or excision of bone spurs. Injection of steroids can instigate or exacerbate~     pre-existing heel fat pad atrophy. Autologous fat grafting to the heel may reduce plantar~     pressures, and thus serve as a treatment for heel pain. Autologous fat grafting is currently~     under investigation for a myriad of clinical scenarios.[6-19] Even though autologous fat~     grafting is not yet an established therapeutic approach for the cited indications, some of~     the reported results have been intriguing.[19] The variable resorption of fat, however, is~     an important confounding factor in all these studies. Currently the literature reports fat~     retention rates ranging from 25% to 80%.[20]~      The specific aim of this study is to assess the adipose stem cell characteristics in~     patients undergoing autologous fat grafting for heel fat pad atrophy and correlate these~     characteristics with fat retention. Data from this study will help determine the~     characteristics of the adipose stem cells in this population and open the door to additional~     studies. This pilot study will also help build new collaborative efforts between Foot and~     Ankle Specialists, Plastic Surgery, and Adipose Stem Cell Biologists, combining~     biomechanical expertise with fat grafting and basic science expertise.~   "
45204|NCT02465320|"~     The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive~     gel) will be effective as an acute-use anesthetic and can decrease the pain intensity~     associated with gynecologic procedures using endometrial biopsy as a representative~     procedure.~   "
45205|NCT02465307|"~     Delirium, as a common complication of hospitalization, poses significant health problems in~     hospitalized patients. Though about a third of delirium cases can benefit from intervention,~     detecting and predicting delirium is still very limited in practice. A common~     characterization of delirium is changes in activity level, causing patients to become~     hyperactive or hypoactive which is manifested in facial expressions and total body~     movements. This pilot study is designed to test the feasibility of a delirium detection~     system using movement data obtained from 3-axis wearable accelerometers and Microsoft Kinect~     sensor, in conjunction with electronics medical record (EMR) data to analyze the relation of~     whole-body movement as well as facial expressions with delirium.~   "
45206|NCT02465294|"~     The purpose of this study is to evaluate the addition of two different probiotic~     interventions to a comprehensive behavioral lifestyle intervention on body weight loss and~     overall health in overweight adults.~   "
45207|NCT02465281|"~     The objective the preliminary study is:~        1. to identify correlations between brain lesions and sensorimotor impairments in stroke.~        2. to identify a potential effect of time on correlations between brain lesions and~          sensorimotor impairments by comparing the results in patients with sub-acute stroke~          versus patients with chronic stroke.~        3. to identify possible patterns between brain lesions and sensorimotor impairments that~          might increase our understanding in stroke recovery and guide further tailor-based~          neuro-rehabilitation.~   "
45208|NCT02465268|"~     The purpose of this research study is to determine if an investigational dendritic cell~     vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor~     called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.~   "
45234|NCT02464930|"~     The primary purpose of this study is to test new methods to diagnose BE in time before it~     turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor~     the disease so that complication such as cancer can be diagnosed early. The two new methods~     the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The~     investigators will collect blood, bile and cells from the food pipe and stomach and measure~     for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers~     could help the doctors figure out which patients are at increased risk for cancer of the~     esophagus.~   "
45209|NCT02465255|"~     Acute abdominal pain is a frequent symptom in children admitted to the emergency department~     . In the past the fear of masking a surgical condition has justified withholding analgesia~     in patients with acute abdominal pain. By the 2000s, some clinical trials established that~     opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome~     in children with acute abdominal pain. Despite this, acute abdominal pain is still~     undertreated in this setting. Published paediatric trials studied the effect of opioid~     analgesia administered by parenteral route or by mouth. To the best of our knowledge no~     study investigated the effectiveness of sublingual analgesia.~      The purpose of this randomized controlled trial is to assess the effectiveness of three~     different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in~     children complaining of acute abdominal pain.~   "
45210|NCT02465242|"~     Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC~     states that 1.7 million people sustain a traumatic brain injury each year, with death~     occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly~     require hospitalization. The costs of TBI can be devastating to our society, with the 2010~     economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal~     or hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury~     have high rates of institutionalization, readmission, and disability.~      The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis~     evaluation in the acute phase of care varies widely among physicians caring for these~     patients[3]. With prognosis often in doubt, physicians have difficulty leading families and~     patients toward the most appropriate treatment which often leads to expensive testing and~     patient management. The Brain Trauma Foundation has recommended several early indicators of~     prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale~     score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes~     have been extensively studied, however accurate measurements of these prognostic factors~     have not been performed due to a lack of standardized measuring procedure.~      A new device has been validated to measure both pupil size and reactivity using infrared~     pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi)~     as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial~     pressure readings, however there are no studies correlating the pupillometer findings with~     outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of~     pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable~     predictor of 30-day outcomes in patients with severe TBI.~   "
45211|NCT02465229|"~     Biliary strictures present a diagnostic and therapeutic challenge to clinicians due to~     unsatisfied accuracy of sampling modality. The major problem is very difficult to discern~     malignant from non-malignant strictures, such as patients with primary sclerosing~     cholangitis (PSC). With the poor prognosis and high mortality rate of advanced stage of~     hepatopancreaticobiliary malignancies, early and accurate diagnosis impacts patients'~     outcome and possible surgical candidacy. Therefore, a pre-operative determination of~     malignancy to help plan appropriate treatment is highly desirable.~      Before 2000s, several diagnostic modalities, including laboratory tests, ultrasonography~     (US), computed tomography (CT) scan, cholangiography by percutaneous transhepatic~     cholangiography endoscopic (PTC) and endoscopic retrograde cholangiopancreatography (ERCP),~     and brushing cytology disclosed 13% to 24% false positive rate for suspicious malignant~     hilar strictures. Compared to recent studies, ERCP brushings still suffer from low~     sensitivity (41.6% ± 3.2% (99% CI)) and negative predictive value (58.0% ± 3.2% (99% CI)).~     In order to increase diagnostic accuracy, at least two sampling methods, including brushing~     cytology, biopsy, and fine-needle aspiration is therefore recommended. One article showed~     multimodal tissue-sampling (Brushing + Biopsy + Fine-needle aspiration) increased the~     sensitivity for diagnosis of malignant biliary stricture to 62%. However, no any literature~     demonstrate the best sequence of combined sampling modalities to yield the highest~     diagnostic accuracy. Besides, the role of stricture dilation before or after different~     tissue sampling modality is still uncertain.~      In this study, the investigators want to compare stricture dilation before or after~     multimodal tissue-sampling, including brush cytology, intraductal suction and forceps biopsy~     for the diagnosis of malignant biliary stricture and also assess which kind of the sequence~     of combined tissue-sampling modalities could offer the highest diagnostic accuracy.~   "
45212|NCT02465216|"~     The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE~     vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following~     successful completion of TB treatment with confirmed bacteriologic cure, in preparation for~     a future Phase 2b prevention of TB recurrence trial in the same population.~   "
45213|NCT02465203|"~     Follow-up for viral activity, changes in liver function and safety in patients with no SVR24~     in feeder studies~   "
45214|NCT02465190|"~     This is a case-control study embedded in a surveillance system to determine the~     effectiveness of antenatal maternal influenza vaccination against laboratory-confirmed~     influenza-associated hospitalised illness in infants <6 months of age.~   "
45215|NCT02465177|"~     Unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an~     American intensive care unit (ICU) each year in the US. Despite the high prevalence of~     unhealthy alcohol use in ICU survivors, routine interventions targeted at reducing alcohol~     consumption, alcohol-related consequences, and illness related to alcohol are not currently~     part of the multidisciplinary approach to critical care. Although screening, brief~     intervention, and referral to treatment (SBIRT) has been described in several healthcare~     settings, it fails to address common characteristics of medical ICU survivors including high~     rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and~     intimate involvement of friends and family. This study uses a qualitative approach to~     further understand the needs of medical ICU survivors with unhealthy alcohol use. The~     investigators hypothesize that there are common, modifiable barriers to improving~     alcohol-related outcomes~   "
45216|NCT02465164|"~     The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in~     conjunction with low dose oxytocin is more effective at shortening labor induction times~     than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be~     randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be~     placed by either Resident or Attending Physicians and left in place for 12 hours (protocol)~     in both groups or until it falls out. After either 12 hours or the Balloon falls out,~     oxytocin will be used for the remainder of the induction per current hospital protocol. Time~     to delivery, mode of delivery, average number of hours Balloon remained in place,~     non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum~     hemorrhage) will be recorded.~   "
45217|NCT02465151|"~     The primary objective of this trial is to identify how much protein is required at breakfast~     to promote positive whole body protein balance over the following 9h period.~   "
45218|NCT02465138|"~     Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis.~     Determine if IV ketorolac provides improved post-procedure analgesia.~      Determine if systemic mediators of inflammation are reduced in patients receiving IV~     ketorolac following ERCP.~   "
45235|NCT02464917|"~     The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at~     10L/min via simple facemask to subjects receiving room air in those presenting for scheduled~     cesarean sections.~   "
45236|NCT02464904|"~     Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant~     pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory~     changes, resulting in the induction of anti-tumor immunity?~   "
45219|NCT02465125|"~     BACKGROUND~        -  Vascular surgical patients often receive red blood cell (RBC) transfusions in the~          peri-operative period~        -  RBC transfusion may lead to improved outcome but on the other hand the intervention may~          be harmful~        -  Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below~          5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain~          hemoglobin levels above 6 mmol/L~        -  A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC~          transfusion in patients undergoing vascular surgery.~        -  A trial examining the effect of RBC transfusion on tissue oxygenation is used to test~          the trial-design and feasibility for a trial evaluating post-operative mortality and~          morbidity.~   "
45220|NCT02465112|"~     TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors~     after complete surgical resection of liver metastases treated with In111-Pentetreotide-based~     adjuvant radiotherapy.~      In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The~     objective is to target residual tumor cells and/or micrometastases which escaped surgical~     resection. Given the poor prognosis associated with recurrence, this treatment should~     prevent relapse.~   "
45221|NCT02465099|"~     The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for~     soft tissue removal from vertebral surfaces. The aim of the present study is to compare~     blood loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or~     neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative~     surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will~     assess the possible influence of the device use in secondary perioperative outcomes.~   "
45222|NCT02465086|"~     The purpose of this study is to investigate the correlation and the causality direction~     between mastering linguistic tests and second-order reasoning tasks in the autistic~     population. Linguistic tests include two types of tasks: 1. Mastery of multiple embeddings~     or recursion and 2. Mastery of dialogue particles. Second-order tests include standard~     false-belief tasks.~   "
45223|NCT02465073|"~     Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel~     (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial~     infection at the wound site.~   "
45224|NCT02465060|"~     This phase II trial studies how well treatment that is directed by genetic testing works in~     patients with solid tumors or lymphomas that have progressed following at least one line of~     standard treatment or for which no agreed upon treatment approach exists. Genetic tests look~     at the unique genetic material (genes) of patients' tumor cells. Patients with genetic~     abnormalities (such as mutations, amplifications, or translocations) may benefit more from~     treatment which targets their tumor's particular genetic abnormality. Identifying these~     genetic abnormalities first may help doctors plan better treatment for patients with solid~     tumors, lymphomas, or multiple myeloma.~   "
45225|NCT02465047|"~     Background: Epilepsy and nonepileptic attack disorder (NEAD) are chronic conditions that~     cause many patients to experience a great degree of stress in their everyday lives. Patients~     have also reported stress as the commonest trigger of their seizures, and animal studies~     suggest that stress can make seizures worse. A self-help intervention that would help people~     manage the stress they experience could therefore improve their quality of life and have~     positive effects on the frequency of their seizures.~      Research Question: The study evaluates whether a self-help intervention in the form of a~     brief booklet can improve the quality of life and reduce the levels of stress of people who~     experience seizures. In addition, the study will explore the associations between seizure~     severity and frequency, physiological and self-reported stress, and anxiety and depression.~      Design: The researchers are recruiting patients attending the Outpatient Neurology Clinic at~     the Royal Hallamshire Hospital and measure their quality of life and stress levels before,~     one month and two months after they have been given the self-help stress reduction booklet.~     The researchers will measure the changes in quality of life and stress levels using~     questionnaires and saliva samples.~   "
45226|NCT02465034|"~     The purpose of this study is to examine how different areas in the brain interact with each~     other and how using brain imaging and brain stimulation approaches can influence these~     interactions.~   "
45227|NCT02465021|"~     The goal of the proposed research is to investigate the effects of novel snack products~     differing in macronutrient composition, fibre and sugar content on post-prandial glycemia~     and short-term appetite control in healthy adults.~   "
45228|NCT02465008|"~     The purpose of this study is to determine whether levobupivacaine is effective in the acute~     postoperative pain treatment in periprosthetic breast augmentation~   "
45229|NCT02464995|"~     The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a~     severe asthmatic population with frequent exacerbations.~      This will be a single center randomized and controlled study. Thirty subjects with severe~     asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic~     corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the~     thermoplasty group (bronchial thermoplasty and medical management) or control group (medical~     management only).~   "
45230|NCT02464982|"~     Mammary reconstruction replaces total skin transplant, which may causing patient discomfort.~     It is a simple, painless and reproductible technology that avoids consequences and~     complications related to transplant. Tattoo helps patients to return faster to the normal~     life and close more easily the cancer episode.~      The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola~     tattoo realized following standard care.~   "
45231|NCT02464969|"~     To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring~     anticoagulation for the treatment of a VTE.~   "
45232|NCT02464956|"~     No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such~     as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC~     will offer valuable source of tissue for transplantation in these forms of AMD and may form~     basis for a future treatment option in terms of cell transplantation.~   "
45233|NCT02464943|"~     The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness~     data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate~     Type B aortic dissection.~   "
45237|NCT02464891|"~     This study evaluates the effect of CCX168, a C5aR Antagonist, Oral Administration on Ex Vivo~     Thrombus Formation and Disease Activity in ten patients with diagnosis of Atypical Hemolytic~     Uremic Syndrome with or without genetic abnormalities in the complement system or~     thrombomodulin, on stable chronic extracorporeal or peritoneal dialysis therapy since at~     least 6 months.~   "
45238|NCT02464878|"~     Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured~     islets. Patients will receive three times a week AAT infusions in the peri-transplant period~     for three weeks.~   "
45239|NCT02464865|"~     This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.~   "
45240|NCT02464852|"~     The aim of this study is to evaluate the effects on MND patients of a new collar~     specifically designed for people affected by neck weakness: the Sheffield Support Snood.~   "
45241|NCT02464839|"~     This study was designed to demonstrate the prevalence of onychomycosis in hallux valgus~     patients. Additionally, all the prevalence of tinea pedis, the pattern of clinical~     manifestations, risk factors and coexistence foot deformities with hallux valgus were~     observed and recorded.~   "
45242|NCT02464826|"~     This study was designed to demonstrate the efficacy of this product in non-dermatophyte~     (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.~   "
45243|NCT02464813|"~     This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in~     children and adolescents. In the second part of the study a randomized double-blind clinical~     trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative~     pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on~     neurophysiological monitoring during surgery.~   "
45244|NCT02464800|"~     The medical records of 393 eyes of 326 patients with severe proliferative diabetic~     retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used~     in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual~     outcome and incidences of intraoperative and postoperative complications were compared.~   "
45245|NCT02464787|"~     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study~     extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed~     in subjects who increased their intake of fruits and vegetables. The scores were determined~     using the Raman Spectroscopy. In that study subjects were assigned to one of four groups~     based on their baseline SCS. For unknown reasons, the groups with the highest and lowest~     baseline SCS failed to show an increase whereas the two intermediate groups did. One~     possible explanation might be that intakes varied more than expected and was not obvious due~     to self-reporting of intake of fruits and vegetables with different contents.~   "
45246|NCT02464774|"~     RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a~     high risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent~     impact of breast-conserving therapy (BCT) and mastectomy on disease-free survival in~     patients with early breast cancer has been established by a number of large randomized~     controlled trials and meta-analysis. However, ongoing dispute exists on whether TNBC is a~     good candidate for BCT.~      PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is~     conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in~     treating Chinese patients with early TNBC.~   "
45247|NCT02464761|"~     An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors~     metastasize to the spine. The majority of these tumors are detected before surgical~     intervention is required and most patients receive radiation therapy for symptomatic relief.~     Complete pain control, duration of pain control, high recurrence rates and soft tissue~     complications make radiation a less than ideal treatment. Also, pre-operative radiation~     therapy is a significant negative predictor for surgical outcomes. To improve the treatment~     options for patients with advanced cancer with spinal lesions the research team investigated~     a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic~     spine lesions with limited side effects. PDT involves the use of a photo-activated~     chemotherapeutic agent, given intravenously that when stimulated by non-thermal~     wavelength-specific light allows for selective ablation of tumor tissue. The light is~     delivered to the spine through small fiber optic cables using a diode laser. By combining~     canine and porcine studies the investigators have strong evidence to support that PDT is~     both safe and effective for the treatment of metastatic tumors in the spine. PDT is~     targeted, repeatable, minimally invasive and has limited local and systemic side effects.~     Its use would enhance the treatment options for patients with advanced stage cancer. The~     goal of the present study is to demonstrate that PDT can be safely and effectively given to~     treat spinal metastases in patients with advanced stage cancer who have multiple lesions or~     who have failed radiation or surgical intervention. The effectiveness of this treatment will~     be determined through clinical and radiographic endpoints along with recurrence and~     survival. The investigators intend to demonstrate that PDT is a minimally invasive method~     with low morbidity and mortality by which spinal tumors can be ablated and later stabilized~     through vertebroplasty, optimizing quality of life and providing effective treatment.~   "
45248|NCT02464748|"~     Motor neurone disease (MND) is a rare but debilitating neurological condition that causes~     paralysis of the body's muscles leading to severe disability and eventually death. Patients~     often struggle to travel the long distances to specialist clinics to receive the care they~     require whilst this expert care is often unavailable in the community. Telehealth has the~     potential to enable a specialist team to monitor the health and wellbeing of patients and~     their carers whilst they are at home. This could improve the patient's health, improve the~     quality of life of both patients and their carers, and lead to more effective use of health~     resources.~      This is a randomised controlled pilot study that will involve 40 patients who are cared for~     by the Sheffield Motor Neurone Disease care centre and their main informal carer (a total of~     80 participants). Half of the participants will use the telehealth system for a minimum of~     six months and maximum of eighteen months and information will be collected from patients,~     carers and their care team. This will include collecting clinical outcome measures, health~     resource use and the opinions and experience of using the system. All participants will~     continue to receive their usual care.~      This is a pilot study. It aims to determine the feasibility and acceptability of the~     telehealth system to patients, carers and their health care providers. It also aims to~     determine how a larger trial could successfully evaluate the clinical and cost-effectiveness~     of the system.~   "
45262|NCT02464566|"~     With low carbohydrate dietary approach for both arms, the investigators will examine the~     effectiveness of 12-weeks intensive lifestyle intervention program provided in individual~     sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of~     baseline weight for experimental participants in comparison with active comparator group~     (only one health education session).~   "
48726|NCT02419287|"~     The purpose of this study is to determine the response and the duration of it in patients~     affected by ALK+ lymphoma that are resistant or refractory to standard cytotoxic treatment~     that will be treated with crizotinib.~   "
45249|NCT02464735|"~     Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to~     sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor~     sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the~     gold standard method for evaluating sleep quality and quantity). Discontinuation of~     mechanical ventilation should be considered as soon as possible when a patient's condition~     starts to improve. A patient's ability to be weaned from the mechanical ventilator can be~     assessed using two step approaches including a Rapid Shallow Breathing Index (RSBI)~     calculation then a spontaneous breathing trial (SBT) to determine the likelihood of success~     or failure before considering endotracheal extubation. The rate of weaning failure from the~     first SBT attempt has been reported to be 35-55%. The reason for weaning failure may be~     complex and multifactorial. An association between sleep disruption and weaning outcome has~     never been studied. The goal of this study is to look for an association between poor sleep~     quality and failure of a weaning attempt.~      This study is an observational, physiological study investigating sleep quality and quantity~     in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night~     before a weaning attempt. Sleep characteristics of patients failing or passing the weaning~     attempt will be compared. In addition, we will compare sleep patterns before and after~     endotracheal extubation.~   "
45250|NCT02464722|"~     During endoscopic sinus surgery (ESS), epinephrine local injection and controlled~     hypotension is essential in order to increase the visibility in the operative field and~     reduce the risk. This study is comparing of dexmedetomidine and remifentanil before~     epinephrine local injection for controlled hypotension during ESS.~   "
45251|NCT02464709|"~     This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®)~     and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural~     daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be~     randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL.~     Result of the treatment is assessed with clinical examination 12 months after treatment. The~     investigators will also compare delayed skin reactions after treatment and~     cost-effectiveness of both photosensitizer creams.~   "
45252|NCT02464696|"~     The goal of this clinical research study is to learn whether using early non-invasive~     positive pressure ventilation (NIPPV), a method of delivering oxygen using a mask, or high~     flow oxygen (using a tube with 2 prongs placed in the nostrils) is better at improving the~     amount of oxygen in your blood, reducing shortness of breath, and the need for intubation~     (placement of a tube in the windpipe) in patients with blood cancer and hypoxemia.~   "
45253|NCT02464683|"~     Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4~     centuries in all the world. Observational studies found an association between vitaminD and~     TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with~     active tuberculosis. The hypothesis is that the administration of vitaminD is associated~     with changes in the levels of cytokines in patients with tuberculosis treated with~     first-line drugs. The aim of this study is to evaluate the effect of vitaminD~     supplementation on the clinical course, the time of negative smears and cultures, and the~     effect on the immune response in patients with pulmonary tuberculosis (TBP).~   "
45254|NCT02464670|"~     This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered~     intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well~     tolerated and immunogenic.~   "
45255|NCT02464657|"~     The goal of this clinical research study is to find the highest tolerable dose of nivolumab~     that can be give in combination with idarubicin and cytarabine in patients with MDS and AML.~     The safety and effectiveness of this drug combination will also be studied.~   "
45256|NCT02464644|"~     Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this~     study is to provide data regarding the frequency of common health conditions and the~     tolerability of therapies in HHT by using a questionnaire.~      This will be filled in by both people with HHT, and controls who will be members of the~     general population without HHT.~      The questionnaire has been designed primarily for web based entry, but can also be~     circulated in paper format on request~   "
45257|NCT02464631|"~     In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated~     HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary~     Sciences hospital will be included and those patients meeting the entry criteria received~     treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin~     administered orally twice daily, with doses determined according to body weight(600 mg daily~     in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg,~     and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration,~     patients would be randomized in either of the 3 treatment groups -~        -  Group 1 - Sofosbuvir + Ribavirin x 24 weeks~        -  Group 2 - Sofosbuvir + Ribavirin x 36 weeks~        -  Group 3 - Sofosbuvir + Ribavirin x 48 weeks~   "
45258|NCT02464618|"~     Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The~     overall goal of this proposal is to evaluate the effect of directly involving a social~     contact (chosen by the patient) on completion and quality of out-patient endoscopy~     recommended for the patient by his/her primary care physician, or after scheduling by the~     gastrointestinal endoscopist.~      Improved adherence and better quality of procedures are postulated with involvement of~     social contacts.~   "
45259|NCT02464605|"~     This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity~     of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects~     with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the~     readily soluble allantoin that is then excreted.~   "
45260|NCT02464592|"~     The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial~     lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse~     lung disease.~   "
45261|NCT02464579|"~     The objective of this study is to measure the breastfeeding success for all preterm and term~     newborns in our department of neonatology during the hospital stay and at the age of six~     months.~   "
45850|NCT02456857|"~     The goal of this clinical research study is to learn if receiving 4 cycles of experimental~     chemotherapy before surgery can help to shrink the size of tumors in the breast and/or lymph~     nodes before they are removed through surgery. The safety of this combination will also be~     studied.~   "
45263|NCT02464553|"~     In this prospective multi-centre double-blind trial the effect of the X-ray examinations~     controlled periradicular therapy should be examined in (approximately 300) adult patients~     with low back pain pain caused by foraminal stenosis radiculopathy or spinal stenosis.~      A periradicular therapy (PRT) is a special radiological, low-risk therapy for chronic back~     pain caused by wear and tear of the cervical, thoracic, and lumbar spine or a herniated disc~     or disc bulge. Partially pain might also radiate to the hips or extremities and cause~     radicular symptoms.~   "
45264|NCT02464540|"~     The aim of this randomized clinical trial is to evaluate the influence of luting agent,~     thickness and color of laminate veneers (LVs) and color of dental substrate on the optical~     properties of LVs.~   "
45265|NCT02464527|"~     The purpose of the current study is to deliver the SSP procedure to children diagnosed with~     autism that do not have vocal language. The study will also aim to gather data in the~     natural environment using a voice recorder.~   "
45266|NCT02464514|"~     The hyperghrelinemia of children with PWS provides a unique model by which to explore the~     hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions.~     An important question to be addressed by this proposed research includes the macro-nutrient~     regulation of ghrelin and PYY in obese children and children with PWS. As ghrelin~     antagonists are considered potential future anti-obesity agents, it is essential to gain~     understanding of the developmental, nutritional and hormonal regulation of this important~     orexigenic hormone in children.~   "
45267|NCT02464501|"~     The purpose of this study is to assess the safety and efficacy of paclitaxel administration~     using the occlusion-perfusion catheter (OPC) for the prevention of restenosis in~     infrainguinal de novo and restenotic femoropopliteal stenoses and occlusions.~   "
45268|NCT02464488|"~     Several new oral direct anticoagulants have been recently marketed. However, only a few,~     limited, studies have provided data about the pharmacology of new oral direct anticoagulants~     in older persons. This study try to better define wether the pharmacology of each of these 3~     drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very~     older patients (over 80) and to which extend. The investigators also try to characterize the~     main determinants (age, weight, renal function, co-morbidities, etc) of the variability~     observed between individuals in their response to he drugs studied. The method employed is a~     population pharmacokinetic/pharmacodynamic study.~   "
45269|NCT02464475|"~     Recent evidence suggested that the anterior insula cortex seems to be the main site of~     interoception. Several studies showed an association between change in insula function and~     interoception, bodily perception and consciousness in subjects with chronic pain. Although~     osteopathic research has been demonstrated to be effective in reducing pain, studies~     exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the~     present study is to explore the extent to which osteopathic treatment could modify~     interoception parameters both measuring brain functional connectivity and clinical~     questionnaires.~   "
45270|NCT02464462|"~     The purpose of this study is to investigate the effect of vitamin D3 and calcium~     supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic~     patiens.~   "
45271|NCT02464449|"~     This study will evaluate a new approach for back pain care management using artificial~     intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services~     automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard~     care but with less clinician time.~   "
45272|NCT02464436|"~     hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation~     study in which participants with retinitis pigmentosa will receive a single subretinal~     injection of hRPC cells in one eye to evaluate safety and tolerability.~      Participants will be followed for one year to evaluate the safety and tolerability of hRPC~     Additional testing will seek to establish any preliminary efficacy from hRPC.~   "
45273|NCT02464423|"~     Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic,~     accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health~     priority, but Rwandan youth are more than twice as likely to be on second line therapy than~     adults, and with a median population age of 18.7 years old, adherence is essential for~     Rwanda's future. Resources to provide youth-centered medical and psychosocial care are~     limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the~     long-term consequences of genocide, depression, and gender-based violence, as well as~     logistical issues, negative attitudes, and insufficient parent/caregiver support.~     Preliminary data underscore the utility of culturally-adapted, trauma-informed cognitive~     behavioral therapy (TI-CBT) in reducing depression and traumatic distress among youth and~     adults in Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test~     and compare the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy~     (i.e., TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two~     clinics caring for the largest number of youth with HIV in Rwanda. This proposal answers a~     compelling need for innovative programs to increase ART adherence among HIV+ youth. If~     effective, the study will build Rwanda's capacity to provide much needed services; and,~     involvement by the Rwanda Biomedical Center will ensure wide dissemination.~   "
45274|NCT02464410|"~     The high rate of adverse events, including overdose, resulting from opioid pain medication~     use threatens the quality and safety of pain care in the Veterans Health Administration~     (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a~     highly common condition among VHA patients, and opioid therapy constitutes a primary mode of~     pain treatment.~      This study seeks to address this issue by conducting a randomized controlled trial of a~     brief conversation to improve opioid safety among Veteran patients receiving long-term~     opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited~     and randomized to receive either a single session motivational intervention focused on safe~     opioid use or an equal attention control condition. The primary hypothesis is that the~     motivational intervention will improve opioid safety, decrease risk behaviors, aberrant~     opioid use, and total quantities of opioids prescribed relative to the control condition.~     Study findings will inform efforts to ensure the safety and well-being of Veteran patients~     with pain.~   "
45851|NCT02456844|"~     To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam,~     digoxin, pravastatin, and MTX when coadministered with BMS-986142.~   "
45275|NCT02464397|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS)~     and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes~     requiring percutaneous coronary intervention.~      Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure~     followed by aspirin alone, while patients in the EES group will be treated with DAPT, at~     least for 6 months post procedure. In addition, this study will collect initial information~     about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6~     months, and 12 months.~   "
45276|NCT02464384|"~     Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the~     predictive value of US alone and in combination with cartilage biodegradation markers on~     radiographic progression (change in Ratingen score)~      Secondary objectives:~        -  Correlation of ultrasound synovitis score and clinical disease activity score~        -  Determination of the sensitivity of ultrasound erosion detection compared to MRI~        -  Assessment of the value of including tenosynovitis assessment for predicting~          radiographic progression~        -  Assessment of the predictive value of ultrasound synovitis score at baseline for the~          need to install biologic DMARDs~   "
45277|NCT02464371|"~     ICU acquired muscle weakness (IAMW) is a common disease that is associated with high~     morbidity and mortality. Patients with septic shock are particularly at risk.~      The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council~     score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only~     usable in sufficiently awaken patients.~      Several studies have highlighted the role of microRNAs in regulating physiological processes~     and diseases related to the skeletal muscles. To date, no study was interested in IAMW.~      The aim of this study is to compare the microRNA detection kinetics on the appearance of~     IAMW.~      In septic shock patients, the kinetics of nine microRNAs will be compared between two~     groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).~   "
45278|NCT02464358|"~     HPV infections are prominent among college-aged women. Although HPV vaccines decrease~     women's risk for cervical cancer, vaccination rates remain inadequate. This study explored~     the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV~     vaccination knowledge, motivation, and behavioral skills among college aged women.~   "
45279|NCT02464345|"~     The investigators have developed a new integrated therapy, namely a Healthy Approach to~     weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral~     weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat~     ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle,~     the role of food and physical activity in mood regulation, and revised but clinically~     meaningful goals for weight loss. The investigators propose a randomized controlled trial~     (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The~     two main aims will be to reduce symptoms of ED and to improve weight management. The RCT~     will be conducted in Sydney and in São Paulo with a one year follow-up.~   "
45280|NCT02464332|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a~     cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's~     chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in~     significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical~     outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer~     cells that have spread to other sites in real-time as they operate. This is a safety study~     to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.~   "
45281|NCT02464319|"~     Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by~     keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular~     manifestations may develop. Several immunomodulating agents have been attempted in the~     treatment of pSS without achieving satisfactory results. Currently, there is no approved~     systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in~     diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The~     investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS~     patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment~     in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in~     pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for~     primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo~     group (N = 30)).~   "
45282|NCT02464306|"~     A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ~     Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with~     a first-episode of Clostridium difficile infection (CDI).~   "
45283|NCT02464293|"~     This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of~     psychological therapy, is able to improve the psychological wellbeing of people who have the~     gene for Huntington's disease.~   "
45284|NCT02464280|"~     The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The~     expected value of this project is the definition of proven indications for tomosynthesis,~     which allow replacing CT. Specific goals are the early detection of pulmonary consolidations~     / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.~   "
45301|NCT02464059|"~     This proposal will evaluate a potential mechanism of increased risk of lung function~     impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter~     this pathway. This study will improve the understanding of factors which can lead to chronic~     lung disease. If effective, this application would also provide the justification to study~     vitamin D as a therapy to improve lung health.~   "
45302|NCT02464046|"~     The primary purpose of this study is to investigate the effect of JNJ-42847922 (change~     versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and~     multiple dose administration to participants with insomnia disorder without psychiatric~     comorbidity.~   "
45303|NCT02464033|"~     The objectives of this study is to:~        -  Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and~          etanercept~        -  Evaluate how the above mentioned treatments influence the immune system and endogenous~          insulin secretion~   "
45285|NCT02464267|"~     The aim of this study is to develop a reliable and valid instrument to measure symptom~     management (experience and / or management strategies) during exacerbation episodes in CF~     patients. For the development a sequential exploratory two phase mixed-method study will be~     applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF~     patients who experienced at least one episode of exacerbation in the past year and~     approximately CF 10 patients who are currently experiencing an exacerbation. The latter~     group will be interviewed up to 3 times during and after the antibiotic treatment. The~     instruments initial item list will be developed on basis of the interviews. Up to five~     health professionals will rate the items' relevance. In a further step, items' clarity and~     relevance will be assessed by cognitive debriefing interviews with no more than 10 patients.~     In the last step (part III), the instrument's preliminary construct and concurrent validity~     and reliability will be tested in a larger sample up to 150 patients experiencing~     exacerbation. Patients will be asked to complete the newly developed questionnaires and a~     set of other questionnaires at one time point. For part III, ethic approval will be asked at~     a later date (2015).~   "
45286|NCT02464254|"~     The investigators will conduct a 1-year prospective and randomized study to evaluate the~     initial efficacy of positive affect vs. an educational control to motivate physical activity~     in older adults with high burdens of chronic disease.~   "
45287|NCT02464241|"~     The purpose of this study is to investigate which clinical colour vision assessment fits~     best for preschool children and school children. The investigators are going to investigate~     children with a known colour vision affecting ocular disease, as well as healthy children~     without colour vision deficiency. The goal is to compare the usability and validity of three~     different clinical tests for colour vision assessment which are already well established in~     adults but not yet in children.~   "
45288|NCT02464228|"~     This Phase II studyis designed to investigate the antitumor activity in terms of objective~     response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma~     (PTCL). The total number of patients could be extended to 30 pending on the degree of~     response observed at an interim analysis. Tipifarnib will be administered until disease~     progression then followed approximately every 12 weeks for survival until either death or 12~     months after accrual of the last study subject, whichever occurs first.~   "
45289|NCT02464215|"~     The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2~     radical surgery for distal advanced gastric cancer.~   "
45290|NCT02464202|"~     The aim of this study lies in comparing the outcome of the proposed technique in a large~     sample size group to the outcome of the conventional tooth autotransplantation method and to~     provide sufficient evidence for improving the long-term success rate of the tooth~     autotransplantation procedure.~   "
45291|NCT02464189|"~     The aim of this study is to assess the knowledge, the attitudes and the practices of parents~     of asthmatic children.~   "
45292|NCT02464176|"~     This study will investigate the ability of systemic dexamethasone to prolong the sensory~     block duration for lumbar plexus nerve blockade.~   "
45293|NCT02464163|"~     The purpose of this study is to investigate the safety and immunogenicity of a recombinant~     hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3~     dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA~     formulation.~   "
45294|NCT02464150|"~     This study consists of two projects:~        1. 20 participants with celiac disease on a glutenfree diet are asked to consume gluten~          containing muesli bars for 14 days. Endoscopy is done before and after. Questionnaires~          and sampling of blood and feces are done before, during and after.~        2. 66 non celiac gluten sensitive participants on a gluten free diet are asked to consume~          muesli bars containing either gluten, Fermentable Oligosaccharides, Disaccharides,~          Monosaccharides And Polyols (FODMAP) or placebo daily in one week (three study arms) in~          three consecutive weeks in a random order separated by a wash out period (cross over~          design) in a double-blinded fashion.~   "
45295|NCT02464137|"~     single-modality phase I dose escalation toxicity study for first-line curative treatment of~     head and neck squamous cell carcinoma.~   "
45296|NCT02464124|"~     Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with~     chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of~     varying severity.~      Treatment options include lactulose administered orally or by nasogastric tube or enema,~     non-absorbable antibiotics, and protein-restricted diets.~      Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by~     Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective~     study at the 2008 American Association for the Study of Liver Diseases meeting showing~     clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.~   "
45297|NCT02464111|"~     Research goals include evaluating the relative impact of maternal nutritional status versus~     recent dietary intake on breast milk micronutrient composition, and evaluating the impact of~     a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.~   "
45298|NCT02464098|"~     Diarrhea is a common problem in the pediatric population. Children with cancer are~     especially at increased risk for gastrointestinal infection-related morbidity and mortality~     due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in~     immunocompromised children is poorly understood. In the past, many or most cases of~     gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests~     and a presumption that a large proportion of cases are due to treatment, rather than~     infections. The availability of new diagnostic tests that detect many gastrointestinal~     pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the~     causes of infectious diarrhea in children with cancer.~      Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of~     diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated~     PCR.~   "
45299|NCT02464085|"~     The main goal of this program of research is to advance our understanding of how the~     severely damaged brain changes over the first 12-months post stroke. The investigators will~     determine 'who recovers', 'who does not recover', and 'why'~   "
45300|NCT02464072|"~     This study evaluates the metabolic and clinical results of two well recognized and accepted~     surgical techniques in the management of severe hyperparathyroidism in patients under~     regular dialysis treatment.~   "
45304|NCT02464020|"~     The goal of this study is to assess if oral vancomycin can restore the normal bile acid~     metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease.~     Study participants will provide blood and stool samples in order to evaluate the bile acid~     metabolism before a short course of vancomycin and then again after to assess for change.~     The investigators will also assess the blood and stool of healthy people, and people with~     IBD (without PSC) as a control group.~   "
45305|NCT02464007|"~     In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose~     (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will~     not be enrolled until all subjects at the current dose level complete 28 days without DLT.~     The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease~     response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until~     at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be~     conducted for all tested dose levels to characterize dose proportionality.~   "
45306|NCT02463994|"~     The purpose of this study is to find out whether a brief course of radiation therapy given~     to one area affected by the cancer will improve the chances of responding to immuno-therapy~     in the form of a medicine called MPDL3280A, an antibody against PD-L1. PD-L1 is expressed on~     lung cancers and is known to block the effects of the body's immune system in attacking the~     cancer. Blocking this PD-L1 has been shown to improve the body's immune cells to attack and~     kill the cancer cells in non-small cell lung cancer. The goal of this study is to see if~     prior treatment with radiation will allow improved recognition of the cancer by the body's~     immune cells in the presence of MPDL3280A.~   "
45307|NCT02463981|"~     The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts~     pain empathy.~   "
45308|NCT02463968|"~     Chikungunya is a mosquito-borne viral illness that leads to chronic joint pain in~     approximately one half of patients. The mechanisms leading to long term arthritis in humans~     has not been well established. There is some evidence from animal studies that activated~     macrophages with persistent viral infection may play a role in chronic arthritis however~     these mechanisms have not yet been identified in humans. It is hypothesized that activated~     macrophages harboring persistent active chikungunya virus are responsible for chronic~     arthritis and joint pain in patients. The focus of this proposal is to evaluate synovial~     fluid and blood for direct viral persistence and activated macrophages that may clarify the~     mechanism of inflammatory injury. The results of this study will be directly applicable to~     tailoring trials of therapeutics.~   "
45309|NCT02463955|"~     EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a~     flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.~   "
45310|NCT02463942|"~     In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with~     high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus~     tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of~     tick-borne encephalitis antibodies in serum of a patient with compatible clinical~     presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or~     meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial~     antibodies in serum does not attest Lyme neuroborreliosis.~      Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not~     fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in~     several European countries due to the possibility of double infection. The investigators~     hypothesise that such patients do not benefit from antibiotics. Such an approach may appear~     safe regarding the possibility of borrelial infection, however it can also be associated~     with detrimental consequences such as antibiotic related adverse reactions, negative~     epidemiological impact on bacterial resistance, and intravenous catheter related~     complications.~   "
45311|NCT02463929|"~     The purpose of this study is to investigate the effect of diphenhydramine on the prevention~     of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators~     hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/~     agitation.~   "
45312|NCT02463916|"~     The purpose of this study is too determine the effects of exercise on the gut microbiota and~     immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.~   "
45313|NCT02463903|"~     The purpose of the present study is to develop, implement and evaluate a stress management~     program aiming to improve emotional well-being, health-related quality of life and to reduce~     readmission to hospital in patients with chronic heart failure (CHF).~      Method: A randomized controlled study design will be employed in which the intervention~     consists of Coping Effectiveness Training (CET), a manual-based group intervention based on~     a cognitive transactional theory of stress and coping. The purpose of CET is to improve~     skills to appraise stress, teach a number of techniques to cope with stress, and to give an~     opportunity to interact with other people with similar experiences of living with CHF. The~     control group will receive standard health care. The intervention group will receive seven~     weekly sessions of CET. Self-assessments of; emotional well-being, depression and anxiety,~     illness perception, health-related quality of life, coping strategies and social support~     will be performed before the intervention, directly after the intervention, six weeks, six~     months and one year after the intervention period as well as measuring readmission to~     hospital. In addition, the participants in the intervention group will fill in an anonymous~     written evaluation, with closed and open ended questions, directly after the intervention.~   "
45314|NCT02463890|"~     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It~     does multiply tenfold the occurrence of vascular events, particularly stroke. While~     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to~     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term~     adherence to CPAP is a significant problem and search for alternative treatment is~     essential.~      The investigators hypothesize that long-term exercise training would allow to reduce~     significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will~     compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed~     through in a national based non-profit organization (Fédération Française d'éducation~     Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program~     (NeuroGyV) during nine months against a control group receiving only standard dietetic and~     physical activity counseling.~   "
45315|NCT02463877|"~     The purpose of this study is to determine the feasibility of surgical techniques involving~     minimal entry into the living body approach for tumor reduction and treatment in which~     highly concentrated anticancer drugs are put directly into the abdomen through a tubes~     (HIPEC), and to determine if this approach may improve short-term postoperative outcomes,~     including the development of complications related to surgery within the first 30 days after~     surgery.~      Participation in this study is entirely voluntary. Approximately 30 subjects will take part~     in this single-center study and all will be enrolled at University of California San Diego.~   "
45316|NCT02463864|"~     This study will help to determine whether frail older medical inpatients will benefit from~     targeted exercise sessions performed twice daily while in hospital. Half of the patients~     will complete targeted strengthening, balance and endurance exercises and the other half,~     stretching and relaxation exercises. The exercise sessions will be assisted and supported by~     a senior physiotherapist.~   "
45317|NCT02463851|"~     The GOLD FORCE trial investigates the differences between treatment with a Contact Force~     single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation~     procedures in patients with paroxysmal atrial fibrillation.~   "
45318|NCT02463838|"~     This study will expand and evaluate an existing pilot program to improve care for frequent~     users of acute emergency and inpatient services by providing care coordination and~     management for eligible San Francisco Health Plan members. SF Health Plan's Community-Based~     Care Management pilot program (Program) known as CareSupport serves vulnerable SF Health~     Plan members who are high utilizers of hospital inpatient and emergency departments and at~     extremely high risk for mortality and morbidity due to factors such as housing instability,~     mental illness, and addiction. Care managers, called community coordinators, are trained~     bachelor-level social workers or outreach workers and each have a panel of 30-35 members who~     they directly engage in the community where the members tend to live or congregate~     (shelters, bus stops, coffee shops, community agencies, and by cell phone) to help them~     improve their health and navigate through the health care and social services systems. The~     number of San Francisco Health Plan members who would be eligible for Care Support services~     far outstrips the capacity the San Francisco Health Plan to provide these additional~     services, and the investigators will thus evaluate the intervention using a randomized trial~     design.~   "
45319|NCT02463825|"~     Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease that results in rapid decline~     in normal muscle function and tone leading to difficulties with mobility, eating, drinking,~     breathing, sleeping, and communicating. The disease is progressive and no cure currently~     exists. Most people diagnosed with ALS succumb within 3 to 5 years. The only approved~     treatment to slow the progression of ALS is called Rilutek® (riluzole) which has only a~     modest effect and has been shown to increase survival by a few months.~      Muscular dysfunction present in people with ALS is caused by nerve breakdown and a~     dysfunction in the communication between the muscles and the nerves. The area where these~     communications occur is called the neuromuscular junction. Some recent studies have focused~     on using different medications to enhance communication at the neuromuscular junction with~     the goal of improving muscle function as a result. This approach is unproven but may help to~     slow the progression of the disease.~      Pimozide is a medication that has been demonstrated to enhance communication at the~     neuromuscular junction in fish and mice. This study will look at whether Pimozide may help~     to slow the progression of ALS and how much medication needs to be taken to have an effect.~   "
45320|NCT02463812|"~     Surgery puts a lot of stress on the body, and during recovery from surgery, the body uses a~     lot of energy to help with healing and getting stronger. Often, sugars are given before~     surgery to help give the body an energy boost. Lipid solutions can also be used as an energy~     source and are commonly used as supplements in patients needing long-term nutrition from an~     intravenous route (e.g., total parenteral nutrition) when they can not eat by mouth for a~     medical reason. Intralipid, a solution of lipid molecules from soybeans and eggs, is~     commonly used for patients who need nutrition and energy supplements. The investigators wish~     to test whether giving Intralipid immediately after surgery can improve recovery from major~     surgery.~   "
45321|NCT02463799|"~     This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating~     castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an~     autologous cellular immunotherapy designed to stimulate an immune response against prostate~     cancer. It has been suggested that the immune response may be strengthened by radiation~     therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases~     the immune response and anti-tumor effect against prostate cancer.~   "
45322|NCT02463786|"~     Heart failure (HF) remains to have a poor outcome. Even though recent advances in HF led to~     a reduction of morbidity and mortality, improvement in outcome is much less than expected~     based on large randomized trials. Various reasons may be responsible, such as complexity of~     disease and comorbidities, inadequate diagnosis and inappropriate treatment. So far, little~     attention has been paid on patients seen in primary care. Also, HF care mainly focuses on~     the individual patient-doctor relationship. However, the increasing complexity prevents~     individual physicians from covering all aspects of care. Consequently, multiple stakeholders~     are involved, including both general practitioners and specialists. Still, the relative~     role, the interaction between them and the processes included are hardly defined. These~     aspects may not only be relevant for patient care, but also for the setup of health care~     systems. Whereas multidisciplinary team should resemble a seamless system across primary and~     hospital care, there is a scarcity of research considering how these disease management~     programs perform, in what form they should be offered, and what care and support patients~     and caregivers would benefit most.The INTERACT-in HF (Improving kNowldege Transfer to~     Efficaciously RAise level of Contemporary Treatment in Heart Failure) study is set up to~     determine and assess relevant factors of the quality of HF care. The study evaluates~     processes of HF care, role of relevant care givers and interactions between them. It~     collects data from individual patients to assess characteristics and management of~     contemporary HF patients. This is performed in different countries (the Netherlands, Belgium~     and Germany) to analyze decision making with respect to diagnostics and~     treatment.Cross-sectional mixed-methods are used. Patients and their caregivers are~     interviewed. The patient is the central starting point. Then, the treating GP, cardiologist~     and HF nurse are interviewed. In parallel, retrospective data based on records from these~     patients are reviewed to verify data from interviews and to determine characteristics of~     them. Retrospective data of additional patients are collected to complete the picture of the~     current situation. These data will be used to define bottlenecks that prevent best clinical~     practice to be used in daily care at all levels, comparing practice in different~     countries.Thus, the proposal aims to better understand HF care, which will lead to a better~     care and finally to improved outcome.~   "
45367|NCT02463188|"~     The goal is to adapt and refine an innovative, developmentally-appropriate universal health~     promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while~     engaging teens in the adaptation process to maximize the relevance, appeal, and~     effectiveness of the program for diverse school settings.~   "
45323|NCT02463773|"~     This is a proof of concept study where we aim to study the correlation between the use of a~     simple bedside ultrasound measurement of diaphragmatic muscle excursion with established~     (but time consuming) measurements made to optimize an important setting on the mechanical~     ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute~     respiratory distress syndrome (ARDS) in the medical ICU.~   "
45324|NCT02463760|"~     The purpose of the study is to investigate imaging findings, which can help us to predict~     factors contributing to abdominal aortic aneurysm growth and rupture.~   "
45325|NCT02463747|"~     Neutropenic fever is a life threatening condition that is not rare in patients suffering~     from hematologic disorders, and of paramount importance to early and effective treatment. In~     this trial we concentrate on hospitalized patients with hematologic malignancies who develop~     neutropenic fever.~      In recent years, several studies were conducted to examine possible changes in the~     conventional empirical treatment, assuming that administration of the antibiotics in a~     prolonged infusion would allow for a greater fT > MIC that will lead to a better efficacy.~      These studies were carried out in different populations and there is only limited~     information about the importance of continuous infusion therapy in patients with hematologic~     diseases with neutropenic fever.~      Research goals: The main goal is to compare between two groups of hematologic patients with~     neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and~     the second (control) group will receive the treatment in a fixed time.~   "
45326|NCT02463734|"~     The purpose of this research is to develop the DQoL-OC, a unique questionnaire to evaluate~     the quality of life of people aged 60 or above providing care for a family member with~     Alzheimer's disease or other related dementia at home in the UK.~      This questionnaire is aimed at allowing researchers, health and social professionals, as~     well as the older family carers themselves, to quantify the impact caring in different~     aspects life, for the purposes of economic evaluation or implementation and evaluation of~     interventions. The results from this study will also help us to understand better the~     aspects that affect carers' quality of life and well-being, which may guide future policies~     and the support provided to older family carers in the future.~      The DQoL-OC is being developed in two parts. The first part is now completed and was carried~     out through focus groups with older family carers for discussions about important aspects~     related to their quality of life and well-being in order to create the items of the new~     questionnaire. Its preliminary version contains 100 questions about the practical aspects of~     care and caregiving, carers' feelings and concerns and satisfaction with life and with the~     caring role.~      The second part of the DQoL-OC development is currently being carried out and aims to~     evaluate its validity and reliability for use with older family carers and to reduce it into~     a smaller number of items. About 300 older family carers are invited to answer individually~     the DQoL-OC and other similar questionnaires for these purposes. About 25 participants~     taking part in this study are invited to answer the same questions with an interval of two~     weeks in order to allow us to compare the results and its stability over this period of~     time.~   "
45327|NCT02463721|"~     Several studies have pointed out changes in the epidemiology of the causative bacteria in~     SBP and bacterascites and in their susceptibility to antibiotics. In particular, the~     development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended~     spectrum beta-lactamases in Escherichia coli. The potential emergence of enterococci,~     methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following~     norfloxacin prophylaxis, is also a cause of concern since they may be associated with a~     higher risk of therapeutic failure.~      The microbial etiology of SBP remains relatively constant; however, the antibiotic~     resistance rate especially for third-generation cephalosporins (including cefotaxime and~     ceftazidime), ciprofloxacin, and ofloxacin increased dramatically~   "
45328|NCT02463708|"~     This project will conduct a retrospective clinical database review and a one-time research~     interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the~     Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program~     (COTP). The investigators will recruit CGs whose Care Recipients (CR) met criteria for~     clinically significant cognitive impairment and/or dementia and who received care management~     services through the COTP.~   "
45329|NCT02463695|"~     The pathophysiology of vertigo is complex and usually requires specialist involvement.~     During the diagnostic process, patients commonly undergo tests which assess the integrity of~     the gaze and posture stabilisation mechanisms involving the inner ear (vestibular system),~     the visual systems and the subconscious neural pathways that interconnect them. Whilst these~     tests are useful they fail to provide information concerning the neural connections to the~     cortex and therefore neglect the perceptual aspects of disequilibrium.~      At present the possibility of routine examination of these higher projections remains~     elusive as no practical alternatives to the expensive functional magnetic resonance imaging~     systems exist. However, recently a novel method of recording cortical vestibular evoked~     potentials (CVEPs) has been described.~      CVEPs utilise an existing method used to interrogate cortical projections from the auditory~     system in which sound waves stimulate the inner ear and the resulting electrical responses~     from the brain are recorded. The recent breakthrough is in the realisation that these~     responses also contain information from the balance organs and therefore are a direct~     measure of cortical processing of the vestibular inputs.~      Current evidence shows that CVEPs are present in the normal population and absent in~     patients with no vestibular function. The primary aim for this study is to extend the~     patient cohort to include those who have a vestibular injury but retain residual function.~     Patients going through standard testing will have also have CVEPs on both ears providing~     seminal information into the effect of injury to the peripheral vestibular system on the~     cortical pathways. Furthermore, by following the cohort through their complete management~     pathway it will be possible to ascertain if the CVEP can be used to predict rehabilitation~     outcome success.~   "
45330|NCT02463682|"~     This is a feasibility study of an artificial pancreas (AP) system with our previously~     validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov:~     NCT01929798) integrated into the Diabetes Assistant (DiAs) system.~   "
45331|NCT02463669|"~     The purpose of this study is to determine if splenomegaly on point-of-care ultrasound~     (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and~     Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients~     presenting with sore throat to the Emergency Department (ED).~   "
45394|NCT02462824|"~     The purpose of this study is to determine the effects of a home-based exercise intervention~     on walking ability in people with peripheral artery disease. In 200 patients with peripheral~     artery disease (PAD), the investigators are conducting a randomized controlled trial to~     determine whether a patient-centered home-based exercise program improves walking ability,~     physical activity, mobility, pain, and social functioning, compared to a usual care group.~   "
45332|NCT02463656|"~     Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by~     mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair,~     limb and eye abnormalities. Short stature and underweight have been noted in the majority of~     these patients. Since the pituitary gland arises from ectodermal tissue, the investigators~     suspect that pituitary deficiencies may contribute to poor linear growth. This study will~     examine the nutritional, gastrointestinal and endocrine mechanisms that may account for~     linear growth stunting and low weight that is observed in FDH. The investigators will~     utilize standard clinical tools including a bone age xray, glucagon stimulation test to~     evaluate growth hormone status, baseline laboratory analysis of hormone and~     nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.~   "
45333|NCT02463643|"~     The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40~     mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A~     to D as defined by the LA classification grading system.~   "
45334|NCT02463630|"~     Posterior compression - distraction reduction technique （CDR） in the treatment of Basilar~     invagination associated with atlantoaxial dislocation~   "
45335|NCT02463617|"~     This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).~   "
45336|NCT02463604|"~     This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast~     medium-induced nephropathy in a population of high risk patients undergoing coronary~     angiography. Half of participants will receive a preconditioning procedure while the other~     half will receive a sham procedure.~   "
45337|NCT02463591|"~     The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is~     effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified~     skin-bleeding tests.~   "
45338|NCT02463578|"~     Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil~     cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine~     recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal~     vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks~     later).~   "
45339|NCT02463565|"~     Food provision and consumption were assessed for all hospitalized patients over a 24h-period~     survey. This study is a part of a control quality programme and is performed every 4 years~     since 1999.~   "
45340|NCT02463552|"~     This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory~     Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.~   "
45341|NCT02463539|"~     Descriptive study of the residual anti-pneumococcal immunity in patients with~     Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously~     gone through pneumococcal immunization.~   "
45342|NCT02463526|"~     Participants will be initially assessed for their suitability for inclusion in the study and~     will undergo a physical screening of the affected shoulder and cervical spine by an~     experienced physiotherapist. After, participants will be attended 72 hours after data~     recording of the baseline measures (range of motion with a goniometer, pressure pain~     threshold with a algometer, and peak force with a dynamometer) for four sessions per week~     with 24 hours of interval between sessions. At each experimental week session, each~     participant will receive one of the two treatment conditions (MWM or sham) and then will~     repeats the assessment. In the following week, there will be a crossover condition of each~     individual and 24 hours after the last treatment session, the examiner will do the last~     assessment.~   "
45343|NCT02463513|"~     Approximately 10% of the world's population have a particular genetic makeup (known as the~     TT genotype) that may increase their risk of having higher blood pressure. Previous work~     conducted by the investigators research group at the University of Ulster, in collaboration~     with clinical colleagues from across Northern Ireland, in premature CVD patients and~     hypertensive adults generally has demonstrated that a dietary level of riboflavin (1.6mg/d)~     decreases blood pressure, specifically in those with the TT genotype. To date, the blood~     pressure lowering effects of higher doses of riboflavin in individuals with the TT genotype~     is not known. The aim of this study is to investigate whether supplementation with~     riboflavin at a low dose supplemental level (10mg/d) can decrease blood pressure more~     effectively than the dietary level (1.6mg/d) by optimising riboflavin status and normalising~     MTHFR activity. This aim will be achieved by conducting a double-blind placebo-controlled~     intervention study over a 16 week period.~      Participants will be recruited from cohorts screened for the methylenetetrahydrofolate~     reductase (MTHFR) C677T polymorphism. Those identified with the TT genotype (homozygous for~     the polymorphism) that wish to participate in this research will be asked to attend a~     baseline and week-16 appointment and will be asked to take a daily riboflavin (1.6 or~     10mg/d) or placebo capsule for the duration of the study. At each appointment a blood sample~     will be taken and blood pressure, height, weight and waist circumference will be measured.~     If the results of this study show that intervention with a higher dose of riboflavin can~     lower blood pressure more effectively in individuals with the TT genotype this will have~     important implications for those responsible for the management of blood pressure. The~     findings will be of particular relevance in populations with a higher prevalence of the~     polymorphism.~   "
45344|NCT02463500|"~     This will be a continuing, prospective study of diabetic foot ulcers and infections, risk~     factors and clinical outcomes and a limited data set conducted by the investigator through~     the establishment of a data and tissue repository in the uT Southwestern Department of~     Plastic Surgery. in addition, subjects consented for this research will be asked about~     inclusion in a recruitment database to be used in the recruitment of subjects for future~     research on diabetic foot complications.~      about 250 patients are seen for diabetic foot ulcers and infections each year.~   "
45345|NCT02463487|"~     The investigators plan a randomized clinical trial of 150 patients with infected~     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness~     of negative pressure wound therapy with continuous irrigation and negative pressure wound~     therapy without irrigation.~   "
45346|NCT02463474|"~     This research study will test whether a series of video clips with breast cancer information~     improves knowledge of breast cancer, breast cancer treatment and living with breast cancer.~     Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.~   "
45347|NCT02463461|"~     The primary objective of the proposed study is to investigate the agreement levels of modern~     and well-established actigraphy devices against PSG in healthy as well as patient~     populations for multiple sleep parameters across two study sites (Qatar and New York City).~   "
45348|NCT02463448|"~     This is a prospective, open-label, Phase 1, single center study evaluating the safety and~     efficacy of autologous muscle derived cells as a treatment for chronic underactive bladder.~   "
45417|NCT02462525|"~     This is an open-label, dose-escalation study designed to evaluate the safety,~     pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with~     relapsed and refractory multiple myeloma.~   "
45349|NCT02463435|"~     Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body~     Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and~     environmental factors that lead to increased mortality from cardiovascular disease,~     diabetes, cancer, among others and impairs life quality. Most research on severe obesity~     focuses on surgical alternatives and their results, thus this clinical trial aims to~     evaluate the effect of a non-pharmacological approach based on nutritional intervention and~     supplementation with a functional food, the olive oil. It will analyze the effectiveness of~     interventions on: weight loss, improvements on body composition and inflammatory profile~     (TNF-alfa, interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids~     control, changing eating habits and physical activity practice, modification on bone mineral~     density and sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it~     will be investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6~     gene e Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without~     olive oil. This research looks for improving severely obese patient's care and contributing~     to effective results by reducing costs and risk treatment. The investigators believe that~     this informations will contribute significantly to the scientific field, expanding the~     knowledge about severe obesity.~   "
45350|NCT02463422|"~     According to a recent report from the Centers for Disease Control, most children with ASD do~     not receive a diagnosis and begin receiving treatment until well after their 4th birthday,~     which is unfortunate given that many connections between brain cells have already been~     established by that age. This program will test a model called Get S.E.T. Early (S=Screen,~     E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat~     ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general~     population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT~     Checklist (Wetherby & Prizant, 2002) at well baby check-ups using a triple screen approach~     wherein toddlers are screened at three ages starting at 12 months. Investigators predict~     that providing screening tools with clear cut-off scores and guidelines for automatic~     referral for both evaluation and treatment will result in dramatically lowering mean age of~     detection in Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using~     repeat screening at 12, 18, & 24 months in combination with automatic referral options via~     technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24~     months relative to a single time point screen using traditional paper screens.~   "
45351|NCT02463409|"~     This study will test an investigational drug, theophylline, in children with~     pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the~     Vanderbilt Clinical Research Center.~   "
45352|NCT02463396|"~     The primary aim of this study is to investigate clinical effectiveness of mindfulness~     training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity~     Disorder (ADHD). The secondary aim is to assess whether mindfulness training is~     cost-effective compared to TAU in adults with ADHD from a societal perspective.~   "
45353|NCT02463383|"~     Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2~     (PPARG) polymorphism, were given the following treatments in a random order with a 5w~     wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed~     after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were~     measured before and at three timepoints after alcohol intake. It is hypothesized that the~     acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is~     modulated by ibuprofen and by PPARG genotype.~   "
45354|NCT02463370|"~     Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic~     infiltration performed through ten injections in addition to general anesthesia which was~     associated with less postoperative pain and shorter hospital stay.~      However, the local infiltration technique is time-consuming and requires a large number of~     facial injections. This gave rise to the idea of reducing the number of injections while~     retaining the effectiveness of the local anesthetic technique.~      Decreasing the number of injections could be achieved by blocking the superior maxillary~     nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical~     area as well after induction of general anesthesia.~      The purpose of this prospective double-blind clinical trial was to compare the effectiveness~     of four versus ten local anesthetic injections in terms of postoperative pain relief. The~     secondary objective was to compare patients' and surgeons' satisfaction between the two~     techniques.~   "
45355|NCT02463357|"~     Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of~     non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric~     pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS.~     Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and~     difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance~     and endurance exercise capacity are impaired. Therefore, the goal of this research is to~     identify effective pharmacological agents that will help reduce the symptoms of AMS and~     improve physical and cognitive performance at high altitude.~      The investigators will study the efficacy of the dietary supplement, quercetin, the drugs~     nifedipine (extended release) and methazolamide taken together, the drug metformin, and the~     drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at~     high altitudes.~   "
45356|NCT02463344|"~     This is the long term follow-up of a safety and tolerability trial to evaluate the effect of~     subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells~     in patients with Age-Related Macular Degeneration(AMD).~   "
45368|NCT02463175|"~     Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure~     often undertaken in adolescents. In adult anesthesia, there is a large volume of literature~     debating how to optimize fluids administered during surgery, as both too much fluid and too~     little fluid are associated with worse outcomes. The investigators will compare fluid~     administration based on the measured amount of blood pumped by the heart during each heart~     beat (goal-directed therapy), against standard anesthetic management. The main outcomes are~     a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes~     of administered fluids, and d) length of hospitalization.~   "
45852|NCT02456831|"~     This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term~     infants with reported intolerance to a milk-based formula.~   "
45357|NCT02463331|"~     The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in~     conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in~     US. However, in Brazil the response to these treatments seems to be worse, approximately 35%~     in five years. Because of the side effects of the gold-standard treatment and the need for~     an alternative option for the no responsive patients, news drugs must be evaluated for this~     proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the~     treatment of rheumatological diseases for at the least five decades. Chloroquine was used as~     a single drug for up to two years for the maintenance of AIH remission in an open study.~     There was a 6.49 greater chance of relapse in the historical controls when compared with~     patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to~     investigate whether chloroquine in conjunction with prednisone can be used as an alternative~     treatment of AIH in a randomized study, and to evaluate its side effects.~   "
45358|NCT02463318|"~     The purpose of this study is to investigate the gene expression and activity of SIRT1, and~     forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in~     multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on~     interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis~     and healthy subject .Additionally, we evaluate effect the probable effect of melatonin~     treatment on gene expression and activity of above-mentioned genes in peripheral blood~     mononuclear cells of healthy subjects-treated with H2O2.~   "
45359|NCT02463305|"~     This study plans to learn more about the effects that creatine monohydrate has on disease~     activity in ulcerative colitis. Creatine is a substance that is naturally produced by the~     body and is found in foods, such as meat and fish. Creatine helps to provide energy to some~     body tissues, such as the colon. In the colon, this energy allows cells to form a tight~     barrier between molecules in digested food and bacteria and the body's infection-fighting~     cells within the colon underneath this barrier. If the barrier becomes leaky molecules may~     pass through and lead to inflammation. This leakiness may contribute to the colon~     inflammation seen in ulcerative colitis.~   "
45360|NCT02463292|"~     This study aims to evaluate the psychosocial situation of adult congenital heart disease~     (CHD) patients in terms of health-related quality of life, mental health, academic~     achievement, and employment status. By assessing a wide variety of medical (e.g., disease~     severity) and psychosocial (e.g., life events, coping strategies, personality) risk factors~     it will be possible to better understand the variables that influence psychosocial outcome~     of young adults with congenital heart disease. This will further improve the understanding~     of the lifelong consequences of a congenital heart malformation. Factors that proof to be~     predictors of favorable outcome represent a resource of resilience and therefore should play~     an important role in the care of CHD patients. By implementing those results in patient care~     the investigators aim to achieve an improved psychosocial outcome among adult congenital~     heart disease (ACHD).~      Hypothesis 1: It is expected that perceived health status, health-related quality of life~     and psychological adjustment will not differ between the patient and the control group.~     However, academic achievement and employment status are expected to be poorer in young~     adults with congenital heart disease compared to healthy controls.~      Hypothesis 2: It is assumed that parental socioeconomic status, problems in emotional~     regulation and impaired social support will be related to a negative psychosocial outcome~     and health-related quality of life. Moreover, the investigators hypothesize that disease~     severity is associated with academic outcome and employment status.~   "
45361|NCT02463279|"~     The goal of this study is to evaluate basic usability and confirm expected safety and~     effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid~     sinus ostia in patients with chronic rhinosinusitis.~   "
45362|NCT02463266|"~     The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a~     telephone-based clinical service designed to help identify and manage behavioral health~     issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore~     moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b)~     to evaluate the sustained clinical effects of the program.~   "
45363|NCT02463253|"~     This is a single-center, prospective, non-randomized, observational study to evaluate~     specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft~     nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney~     tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely~     monitored over one year after enrollment.~   "
45364|NCT02463227|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),~     and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV is~     well-controlled with HIV medicines. The study will examine whether VRC01 controls or delays~     the return of HIV viremia when the participants' HIV medicines are briefly stopped during~     the study.~   "
45365|NCT02463214|"~     This study involves sampling bone marrow transplant patients, hospital workers and the~     patient room for microbes using swabs and other techniques. We send these samples to the~     laboratory, where they will use state-of-the art technology to identify and relate the~     microbes to each other. This study also involves putting copper, nickel, or titanium into~     some hospital rooms, and seeing whether these metals influences the growth of microbes. Some~     equipment in the hospital room, such as faucets and soap dispensers will be replaced by~     sensor-based (e.g. touchless) controls.~   "
45366|NCT02463201|"~     The prevalence of childhood obesity has increased at an alarming rate over the last decades,~     both globally and in Denmark. There are a number of serious sequelae related to obesity,~     such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to~     be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be~     associated with cardiovascular complications, neurocognitive problems and reduced quality of~     life. The correlation between obesity and OSA is still poorly understood. Early detection~     and intervention is of great importance as the health consequences related to OSA as well as~     obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with~     OSA. However, only around 25% of obese children benefit from this treatment compared to~     around 75% of normal-weight children suggesting that there might be other structural factors~     predisposing to OSA in obese children.~      In this study the investigators aim to clarify the impact of obesity in the development of~     OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose~     is to assess the effect of weight loss on OSA.~   "
45369|NCT02463162|"~     The Canadian population is aging and more people are living with advanced chronic diseases.~     At the end of life (EOL), the use of invasive medical treatments in hospitals is increasing~     and associated with worse outcomes. Advance Care Planning (ACP) may help improve care at EOL~     to be the way patients want it. ACP is a process where people think about the various~     options related to future health care decisions and they may communicate with a verbal or~     written plan of what care they would want in the EOL. Also, they may nominate a substitute~     decision maker if they become unable to speak for themselves. A national poll found that few~     Canadians have thought about or made an ACP.~      Alberta Health Services has developed two videos (Videos) to help with decision making about~     ACP and goals of care designations(GCD). GCD are medical orders of care that (a) serve as a~     communication tool for HCP to assist in rapid decision making; and (b) guide HCP and~     patients regarding the general intent and locations of care, and interventions that are to~     be provided. This study will compare ACP behaviours and GCD preferences for participants who~     have seen the Videos with those who have not and measure the change in those behaviours and~     preferences at 1, 2 and 3 months. It will also look at the impact of the Videos on health~     care costs and service use. Participants from five patient groups (metastatic lung cancer,~     colorectal cancer, gynecological cancer, renal failure, and heart failure) were selected as~     representative of where ACP should ideally be occurring, and where data on ACP~     implementation is presently most lacking, and as venues in which this research is most~     feasible. Collecting information about patients' ACP and GCD preferences may help improve~     AHS decision making tools and more generally help healthcare leaders plan ways to better~     engage patients in the ACP process.~   "
45370|NCT02463149|"~     This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based~     experiential culinary and nutrition literacy curriculum for middle-school students. The~     primary study hypothesis was that students assigned to YCA would demonstrate greater~     improvement in F/V and whole grain consumption compared to students in the control group.~     Eight classrooms in eight public K-8 schools participated in the project. Classrooms were~     assigned to intervention or control condition in a non-randomized manner. YCA was delivered~     by project staff to all of the students in the four intervention classrooms. Students~     completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum~     completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum~     cohort).~   "
45371|NCT02463136|"~     Adolescents are particularly vulnerable to psychological problems, partly because of~     dramatic changes in the brain, along with changes in social interactions patterns as they~     move from childhood towards adulthood. One of the most common problems is anxiety, which~     affects up to 1 in 4 adolescents. Moreover, paediatric anxiety predicts lifelong persistent~     mental health problems, which are estimated to cost the UK taxpayer £8.6 billion annually.~     Young people with anxiety experience intense fears and worries, leading to problems with~     friendships, poor school performance, and long-term mental health difficulties. Research~     investigating how and why some young people develop anxiety is therefore critically needed~     so that strategies for early intervention can be developed.~      This research will test the hypothesis that using a novel training intervention, - which~     teaches participants to change the way that their brain responds to emotional stimuli - will~     allow the investigators to influence response strategies while they are being established~     and possibly reduce the risk for anxiety in the long run. To achieve this, the investigators~     will test 50 adolescent females (aged 14-17 years) varying in anxiety levels to investigate~     whether brain responses in emotion regulation regions can be up/down regulated using~     fMRI-based neurofeedback.The rationale behind this research approach is that successful~     changes in brain response may then provide the participant with an additional, 'bodily'~     feeling of how respond to an emotional stimulus in real life situations, thereby paving the~     path towards the development of effective, age-appropriate intervention approaches.~   "
45372|NCT02463123|"~     Estimation of energy requirements is essential for adequate nutritional support in ICU.~     Indirect calorimetry being the golden standard of resting energy expenditure estimation is~     not available in most intensive care units. Different predictive equations have been~     developed, but not evaluated in cardiac population and have low accuracy in compare to the~     indirect calorimetry. The aim of present study is to develop cardio-specific equation for~     resting energy expenditure estimation.~   "
45373|NCT02463110|"~     Primary purpose:~      To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI)~     compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as~     recommended by a double antiplatelet therapy, aspirin and clopidogrel.~      Hypothesis:~      The benefits of SSRIs observed in depressive patients with ACS are related to an~     antiplatelet effect.~   "
45374|NCT02463097|"~     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects~     with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate~     that the closed loop algorithm that is built into the 670G insulin pump is safe as part of~     the overall system.~   "
45375|NCT02463084|"~     This study compares the effects of a one-month diet high in saturated fat (SF), glycemic~     index (GI), and salt (Na+) to a diet low in these nutritional parameters on memory and other~     cognitive functions, on MRI measures of brain structure, function, and perfusion, as well as~     on blood and cerebrospinal fluid levels of amyloid-beta (Aβ), insulin, lipids (total~     cholesterol, HDL, LDL, oxidized LDL, and triglycerides), cytokines, apolipoprotein E (ApoE),~     apolipoprotein J, cortisol, soluble low density lipoprotein receptor-related protein (sLRP),~     and glucose in middle-aged adults (45-65 years of age) with normal cognition or mild~     cognitive impairment.~   "
45376|NCT02463071|"~     This study is a randomised, double-blind phase III long-term study to evaluate efficacy and~     safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients~     with hyperlipidemia accompanied by hypertriglyceridemia .~   "
45377|NCT02463058|"~     Israel ministry of defense is examining a new protective undergarment of GORE company~     (chempark fabric) for the police forces. The goal of this research is to perform a~     comparative experiment in order to evaluate the physiological strain induced by a BC~     protective undergarment under exercise-heat stress conditions.~   "
45378|NCT02463045|"~     This study evaluates the safety and tolerability of TOP1288 rectal single and multiple~     ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.~   "
45379|NCT02463032|"~     The purpose of this study is to determine if GTx-024 at different dosages (9 mg or 18 mg) is~     effective and safe in the treatment of patients with metastatic or locally advanced ER+ and~     AR+ breast cancer in postmenopausal women.~   "
45393|NCT02462837|"~     The objective of this pilot study is to assess whether Myrbetriq™ will improve~     post-operative ureteral pain and discomfort, reduce bladder storage symptoms and increase~     quality of life following ureteral stenting.~   "
45380|NCT02463019|"~     This open-label study is an roll-over extension of a randomized trial Efficacy of Tenofovir~     Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight~     Aminotransferase Elevation (NCT01522625).~      After finishing the 3-year therapeutic trial, all patients receive open-label TDF for~     another 3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after~     the 3-year open-label therapy. During the 3-year period, patients were followed up every 12~     weeks for the biochemical, serological, virological parameters, and adverse reactions.~      The primary outcome is the progression of liver fibrosis. Safety issues such as change of~     renal function and bone mineral density are 2nd outcomes.~   "
45381|NCT02463006|"~     Till date, no study has been reported in the literature where porous bioactive glass was~     used for the management of periodontal osseous defects. In this context, the present study~     is designed to assess the efficacy of the porous variant of bioactive glass and compare with~     that of nonporous variant using cone beam computed tomography.~   "
45382|NCT02462993|"~     Background: Aloe vera is considered to be the most promising and high-ranking agent as an~     all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to~     evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel~     as an adjunct to scaling and root planing in the treatment of chronic periodontitis.~   "
45383|NCT02462967|"~     Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo~     controlled, double blind study. This study will enroll subjects with portal hypertension~     (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak~     stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and~     those with decompensated cirrhosis.~      Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to~     receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean~     body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week~     over a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis~     is the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with~     placebo as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week).~      An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will~     be performed before the first infusion and after the final 26th dose of IMP. Additionally,~     subjects will undergo a FibroScan (if available) prior to the first infusion, at Infusion~     Visit 13, and 14 to 28 days following final 26th infusion, an MBT (if available) will be~     performed at screening, at Infusion Visit 13, and 14 to 28 days after the final infusion,~     and blood will be collected for assessment of biomarkers.~      All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the~     final dose administration and a second will occur 14 days following the first postdose~     visit.~      Subjects will be offered enrollment into a subsequent separate study, an open label~     extension study, if there is adequate tolerability and no safety issues or signs of clinical~     progression that would recommend discontinuation.~      Subjects who do not enroll in the open label extension study will be contacted via telephone~     every 6 months for 2 years and annually thereafter for a total of 4 years.~   "
45384|NCT02462954|"~     The purpose of this study is to evaluate the safety of ContraGel versus the~     hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during~     two 7-day periods of daily use, the first without intercourse and the second with~     intercourse.~   "
45385|NCT02462941|"~     Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia~     is one of the largest pediatric heart transplant centers in the world, averaging 25~     transplants per year, and providing ongoing care to nearly 250 children with transplanted~     hearts. After transplant, children are at increased risk to develop sudden onset of~     abnormally fast heart rates. This research project will study adenosine, a medication that~     is routinely used to slow fast heart rates in non-transplanted children (i.e. normal~     hearts), and its effects on the transplanted heart. Adenosine is often not used in patients~     with transplanted hearts because, based on prior limited research in adult patients, the~     standard adult dose may have a longer medication effect, producing a slower heart rate for~     an undesirable period of time. However, the current alternatives to adenosine treatment are~     either inappropriate for the pediatric age range, or have increased risk of unwanted side~     effects. This research project will answer two questions: is adenosine safe to give a child~     who has had a heart transplant, and will it be effective in treating the fast heart rate?~      All pediatric heart transplant patients undergo regular heart testing, known as a cardiac~     catheterization, one or more times per year. Three days before testing, participants will be~     asked to stop a regular medication, dipyridamole, because it slows the breakdown of~     adenosine in the body, and may increase its effects. (Of note, all patients that are on~     dipyridamole are also on aspirin, which gives a second line of heart protection, and will~     not be stopped.) After regular cardiac catheterization, all patients will already have~     intravenous (IV) access to give medication. Also, this setting allows the opportunity to~     have a back-up pacing catheter in the heart, ensuring that there will not be a longer than~     desired effect from the medication. Adenosine will be given per a low-dose protocol until~     either the medication effect is seen or the maximum dose is reached. There will be no~     difference in procedure recovery period time, and patients will resume regular home~     medications after finishing the test. As Columbia is one of largest pediatric heart~     transplant centers in the world, studying the effects of adenosine at low doses will benefit~     the investigators population greatly, either to find a new recommended medication dose, or~     to provide evidence that this medication is truly inadvisable for the investigators~     patients.~   "
45386|NCT02462928|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration.~   "
45387|NCT02462915|"~     In our study, we compared the ventilation performance of i-gel to the endotracheal tube~     during laparoscopic surgery.~      The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we~     wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal~     volume, peak airway pressure and mean airway pressure.~      In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during~     volume controlled ventilation in laparoscopic surgeries.~   "
45388|NCT02462902|"~     300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis~     and sepsis induced hypotension to the intensive care unit, the emergency department and the~     step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the~     inclusion criteria.~      This study will be a single centre prospective randomized comparative trial. Patients will~     be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride~     solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin~     (250 ml over 15 minutes).~   "
45389|NCT02462889|"~     This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept~     injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related~     macular degeneration (AMD) in high-risk subjects.~   "
45390|NCT02462876|"~     This study will assess the long term safety and performance of the GORE® VIABAHN®~     Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.~   "
45391|NCT02462863|"~     The purpose of this research study is to determine if the nutrients arginine and fish oil~     will reverse or improve diabetes and to find out what additional good or bad effects a~     combination of arginine and fish oil may have. Both arginine and fish oil are common~     nutrients taken by normal people on a frequent basis. However, they have not been used in~     combination in the proposed doses to reverse diabetes once it is established. This study has~     been approved by the Food and Drug Administration (FDA investigational new drug [IND]~     12191).~   "
45392|NCT02462850|"~     The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of~     CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate~     to severe acute pain (flare) associated with osteoarthritis of the knee or hip under~     actual conditions of use.~   "
45395|NCT02462811|"~     The objectives of this study are to compare the occurrence and severity of opioid-induced~     nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy~     of CL-108 when compared to placebo for the relief of moderate to severe pain In patients~     with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of~     the first metatarsal bone).~   "
45396|NCT02462798|"~     Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major~     source of iron, but much of this is not bioavailability due to it being bound by the high~     amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can~     release iron and increase its bioavailability. In a human cell model of iron uptake,~     sourdough fermentation, which included activation of phytase, the enzyme that breaks down~     phyate, led to improved iron bioavailability. This clinical trial will attempt to~     demonstrate that this concept also works in humans~   "
45397|NCT02462785|"~     Helping individuals with diabetes to control their blood sugars through self-management is~     an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education~     and management. There is very little research examining CHO counting education with~     adolescents who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate~     a newly developed internet-based teaching module of CHO counting for adolescents, ages 12-17~     years, with T1DM and who do not regularly CHO count and require instruction. A secondary aim~     is to assess feasibility for a future, larger-scale clinical trail. An effective web-based~     CHO counting tutorial could be used to strengthen current diabetes education programs and~     may serve as a basis for developing other teaching modules. Advantages of web-based teaching~     include convenience, increased accessibility, and the ability to review and reinforce~     teaching concepts through repetition. It may also encourage adolescents to take the~     initiative for their own diabetes care, beginning with a self-directed, active learning~     experience.~   "
45398|NCT02462772|"~     The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA)~     injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in~     KwaZulu-Natal, South Africa.~   "
45399|NCT02462759|"~     The primary objective of Part 1 of this study is to assess the safety and tolerability of~     Nusinersen in participants with SMA who are not eligible to participate in the clinical~     studies ISIS 396443-CS3B (NCT02193074) or ISIS 396443-CS4 (NCT02292537). The secondary~     objective of Part 1 of this study is to examine the pharmacokinetics (PK) of Nusinersen in~     participants with SMA. The primary objective of Part 2 of this study is to assess the~     long-term safety and tolerability of Nusinersen in participants with SMA who participated in~     Part 1 and completed their End of Part 1 Evaluation assessments. The secondary objective of~     Part 2 of this study is to examine the PK of Nusinersen in participants with SMA who~     participated in Part 1 and completed their End of Part 1 Evaluation assessments.~   "
45400|NCT02462746|"~     The purpose of this project is to study the effect of dietary supplementation with a natural~     health product (NHP) with a focus on its effects on its levels in breast milk.~   "
45401|NCT02462733|"~     Self-control has become a strong predictor of academic success and life outcomes. Early~     childhood development research indicates that greater self-control can lead to better~     health, greater wealth, and less propensity to engage in criminal activity. This study seeks~     to assess the strength of the play-based Tools of the Mind (TOM) program in improving~     preschoolers self-control. It will compare TOM to an alternative play-based program, called~     Playing to Learn (PTL), implemented in most YMCA Canada childcare settings across the~     country. This study hypothesizes that measures of self-control and other measures of social~     behavior and academic success in preschoolers after two years in the TOM program will be~     greater than measures of self-control and other measures of social behavior and academic~     success in preschoolers in the PTL program after two-years.~   "
45402|NCT02462720|"~     The purpose of this study is to evaluate pain the patient experienced following treatment of~     varicose veins with Varithena® compared to radiofrequency ablation.~   "
45403|NCT02462707|"~     The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014~     single-agent administration in Japanese patients with advanced solid tumors.~     Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.~   "
45404|NCT02462694|"~     Suicide is a pressing problem in the US military, with evidence of increased risk for~     suicide particularly among soldiers serving in Iraq and Afghanistan. To date, there are very~     few studies that empirically evaluate treatment efficacy to prevent suicide. One treatment~     that has been shown empirically to decrease suicidal behavior is Dialectical Behavioral~     Therapy (DBT), although these studies have been limited to patients with borderline~     personality disorder (BPD). The current proposal aims to examine the efficacy of DBT in~     reducing suicidal behavior more broadly in a diagnostically heterogeneous group of veterans~     with high risk suicidal behavior. One of the difficulties in doing research in suicide~     prevention is that serious suicidal behavior is a relatively rare event, and alone is not a~     satisfactory target for treatment studies. It is extremely important, therefore, to identify~     intermediate symptoms that are closely associated with high risk suicidal behaviors, as~     targets for treatment. One critical area our proposal addresses is validating new treatment~     models for suicide in veterans; DBT has been empirically validated to reduce suicidal~     behavior in individuals with BPD, but has not been tested more broadly to target suicidal~     behaviors. The second critical area which our proposal addresses is exploring new suicide~     risk assessment measures. While the investigators do not specifically propose to develop new~     screening tools, the investigators do propose to identify potentially important domains that~     specifically differentiate ill high risk suicide veterans from low risk. This information~     will be useful in future efforts to modify the DBT approach to be more effective for the~     broader diagnostic group of high risk suicidal veterans.~   "
45405|NCT02462681|"~     This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to~     bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.~   "
45406|NCT02462668|"~     This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted~     intubation during noninvasive positive pressure ventilation in respiratory failure patients.~     Half of the participants will receive preoxygenation with noninvasive ventilator and~     fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual~     preoxygenation(bag-mask ventilation ).~   "
45407|NCT02462655|"~     Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by~     mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from~     the plasma compartment. Heterozygous patients present a 2- to 3-fold raise in plasma~     LDL-cholesterol (C) concentrations, tendinous xanthomatosis and premature atherosclerotic~     coronary heart disease (CHD), usually occurring between the age of 35 and 55 years. Since~     the mid-1970s, LDL-C has been removed from the blood of patients using plasmapheresis, and~     this technique has been shown to improve the life expectancy of FH homozygotes. LDL~     apheresis selectively removes LDL particles but not immunoglobulins and other beneficial~     proteins, thereby overcoming a potential drawback of the traditional plasmapheresis method.~     LDL-C is effectively reduced by more than 60% immediately after LDL apheresis, although LDL~     levels rebound rapidly.~      Dextran sulfate adsorption is a commonly apheresis technique used in familial~     hypercholesterolemia patients. In this apheresis plasma is separated from red blood cells~     and passed over columns of cellulose beads containing dextran sulfate which binds~     apolipoprotein B (apoB) by a highly selective electrostatic binding mechanism. Since LDL,~     very-low density lipoprotein (VLDL), and Lipoprotein (a) all contain apoB, dextran sulfate~     adsorption apheresis selectively reduces these lipoproteins while having little effect on~     the non-apoB containing HDL particles. In clinical practice, LDL apheresis reduces the rate~     of future cardiovascular events and has been postulated to have additional effects on~     potentially pro-atherogenic factors. Some proteins have been identified with adhesive~     characteristics to lipoproteins, rheological, immunological and inflammation relevant~     proteins16-19 that influence microcirculation as well as the inflammatory response. However,~     no studies have yet to investigate the impact of LDL apheresis on the expression of~     different genes involved in cardiovascular disease.~      The main objective of the present research project is to investigate the impact of the LDL~     apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mRNA)~     expression of genes involved in cardiovascular disease using microarrays analysis in 9 FH~     homozygotes.~   "
45408|NCT02462642|"~     The Indian Ayurvedic herb Brahmi (Bacopa monniera) has been used to improve cognitive~     functions in Indian sub-continent for many years and previous intervention studies have~     shown positive effects of Brahmi on cognitive performance in adults. However, the studies~     are conducted on various fractions and extracts and there is high likelihood of variability~     of composition amongst the fractions/extracts tested in these studies. Furthermore, although~     the findings of the previous studies overlap to some extent, they are not consistent and~     there is a need to replicate these findings.~      Further, even though Brahmi has been studied for its chemical composition and its~     therapeutic benefits as a whole, there are still severe gaps with respect to the complete~     composition of the Brahmi plant or its extracts. No published data exist on the~     Pharmacokinetics (PK) properties of Brahmi components. Hitherto, the evidence and the~     mechanistic details are still speculative and the biological activity is still~     phenomenological. Because of this severe knowledge gap, this study will try to repeat the~     findings on cognitive performance and at the same time also explore the plasma levels of its~     components in order to initiate the understanding of ADME aspects and its linkages to the~     biological effect.~   "
45409|NCT02462629|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and~     reduced patient survival. In some sites, such as the brain, it is critical to avoid damage~     to normal tissue around the tumor to prevent adverse effects of surgery on function. The~     investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons~     to visualize the edges of the tumor and small groups of cancer cells that have spread to~     other sites in real-time as they operate. This is a safety study to assess the safety of~     BLZ-100 in pediatric patients with central nervous system tumors.~   "
45410|NCT02462616|"~     This is a large-scale, community-based, cross-sectional study to evaluate environmental and~     genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.~   "
45411|NCT02462603|"~     Open-label study with 30-day run-in phase and adaptive design component to include more~     subjects if deemed appropriate by investigators.~   "
45412|NCT02462590|"~     Probiotics are commercially available live bacteria thought to have health benefits when~     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found~     that in patients who receive probiotics, there is a 25% reduction in lung infection, known~     as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of~     developing any infection in the ICU. However, the studies reviewed were small and not well~     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large~     carefully performed study is done to evaluate the effects of probiotics in critically ill~     patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for~     which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment~     for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no~     cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing~     search for more effective strategies to prevent serious infection during critical illness.~     Probiotics may be an easy-to-use, readily available, inexpensive approach to help future~     critically ill patients around the world.~   "
45413|NCT02462577|"~     This study investigate the effect of addition morphine to locally instillation bupivacaine~     on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery~     and on the probability of developing chronic neuropathic pain.~   "
45414|NCT02462564|"~     Objectives to investigate the incidence and associated factors for early postoperative~     cognitive dysfunction in the patients with peritoneal surface malignancies undergoing~     cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods~     fifty patients aged 18-65 yr were included in the research and were grouped base on the~     score of neuropsychological assessments which had done in the ward at 7 day before and after~     the surgery. The investigators monitored various indicators in the perioperative period,~     such as age, body weight, sex, education, duration of operation, intraoperative blood loss,~     cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of~     serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at~     the various stage of the operation and 24 hours after the operation, and the differences of~     data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.~   "
45415|NCT02462551|"~     The purpose of this study is to determine the efficacy and any possible side effects of~     focal electrically administered seizure therapy (FEAST) as a treatment intervention for~     patients with recurrent and treatment resistant depression.~   "
45416|NCT02462538|"~     This is an open label pilot study of combining BV in a licensed indication with imatinib in~     patients with ALCL. It is intended as a window of opportunity trial in which the study~     drugs will be given as an initial substitute for conventional chemotherapy with the~     intention to achieve a remission enabling the patients to proceed to autologous or~     allogeneic stem cell transplantation, if eligible.~   "
45418|NCT02462512|"~     For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be~     an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive~     procedure and is subject to sampling and analysis uncertainties. Thus, improved, more~     reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound~     elastography has been shown to be useful in the differential diagnosis of breast and~     prostate cancers. Ultrasound elastography also may discriminate malignant from benign~     nodule.~   "
45419|NCT02462499|"~     The aim of the study is to determine the efficacy and safety of treatment with the drug~     eplerenone in patients with chronic central serous chorioretinopathy.~   "
45420|NCT02462486|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration.~   "
45421|NCT02462473|"~     The purpose of this study is to determine the number of Medication Treatment Modifications~     (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels~     (AMPL) results are available compared to when AMPL results are not available.~   "
45422|NCT02462460|"~     The purpose of this study is to create a rapid scan of the pancreas and ovaries that could~     be used in the future to screen patients at risk for pancreatic or ovarian cancers.~     Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can~     last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI~     evaluation that can be used as a screening tool that is completed in approximately 15~     minutes. They will compare different tools available on modern MRI scanners to see which one~     reliably offers high quality images of the pancreas and ovaries.~   "
45423|NCT02462447|"~     Men with and without prostate cancer will have a PET/CT scan that measures the level of the~     amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.~   "
45424|NCT02462434|"~     This study evaluates maternal psychological distress and the impact of early palliative care~     team consultation on maternal anxiety and depression symptoms, coping, and quality of~     life/family functioning in the care of neonates born with single ventricle physiology. Half~     of the participants will receive early palliative care team consultation, while the other~     half will receive usual care (no or late palliative care intervention). The investigators~     hypothesize maternal stress, anxiety, and depression will be lower in the palliative care~     intervention group compared with the control group, and maternal coping mechanisms and~     perceived quality of life and family functioning will improve at the pre-discharge~     assessment.~   "
45425|NCT02462421|"~     Sodium-dependent glucose transporters (SGLTs) are a family of glucose transporters expressed~     on the apical surface of epithelial cells in the intestines and kidneys. Their function is~     to actively transport glucose across epithelia into the blood. Members of the SGLT-family of~     transporters include SGLT1, SGLT2, SGLT3 and SGLT4, with SGLT2 being the primary glucose~     transporter in the kidney. SGLT2 inhibitors are a new class of anti-diabetic drug approved~     as treatments for type 2 diabetes (T2DM). These drugs inhibit SGLT2-mediated reabsorption of~     glucose in the renal proximal tubule -- thereby increasing urinary glucose excretion and~     decreasing plasma glucose levels. We hypothesize that the pharmacodynamic response to SGLT2~     inhibitors (specifically canagliflozin) varies among individuals, and that a proportion of~     this inter-individual variation can be explained by genetic variation. To explore this~     hypothesis, we will conduct a pilot study in healthy, non-diabetic subjects in whom glucose~     and other related metabolites in the urine and plasma will be measured before and after~     administration of a single dose of canagliflozin. This will allow us to characterize the~     inter-individual variation in the pharmacodynamic response to canagliflozin as well as~     determine if changes in glucose and other related metabolite levels are associated with~     variants in candidate genes (SLC5A4, SLC5A9, and SLC2A9).~   "
45426|NCT02462408|"~     The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided~     infraclavicular brachial plexus block. However this technique is less popular because~     brachial plexus at the infraclavicular level runs deeper compared to its course proximally,~     often give rise to impaired needle visualisation due to its steep angle of needle trajectory~     to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to~     improve needle visibility. This approach proved feasible from our case series hence the~     investigators would like to compare it with the conventional method in this study~   "
45427|NCT02462395|"~     Cluster headache is a primary headache that chiefly affects young men, and is less common~     than migraine. This disease can have devastating consequences due to the pain intensity (it~     is also called suicide headache), to the side effects of the drug preventive therapies,~     and to the resistance of some subtypes of the headache to all existing medications.~      Recent studies suggest that cluster headache could be associated with a decrease of the~     activity of frontal areas involved in descending pain control, in particular the subgenual~     anterior cingulate cortex. The aim of this pilot study is to activate these areas with a~     non-invasive neurostimulation technique, called transcranial direct current stimulation, as~     a preventive treatment for cluster headache sufferers.~   "
45428|NCT02462382|"~     Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an~     outpatient basis. Postoperative pain control regimens can include narcotic pain medicine,~     non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene~     block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the~     shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very~     painful when the block wears off. The purpose of this study is to:~        1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during~          the first two days after arthroscopic rotator cuff repair.~        2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and~          placebo catheters after arthroscopic rotator cuff repair.~        3. Evaluate for any continued pain relief benefit of continuous infusion scalene block~          ropivacaine catheters during the three days after the infusion catheters have finished.~   "
45429|NCT02462369|"~     This study compare the effects on microalbuminuria improvement in type 2 diabetes mellitus~     (T2DM) treated with saxagliptin or glimepiride.All patients received metformin and/or~     acarbose, and randomly receive saxagliptin (5mg/d) or glimepiride (1-4mg/d).~   "
45430|NCT02462356|"~     This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of~     participants will receive multiple VATS, while the other half will receive uniportal VATS~     lobectomy.~   "
45431|NCT02462343|"~     All measurements are performed on two consecutive days at the beginning of a pulmonary~     rehabilitation program in a randomized cross-over study design. On the first day, each~     patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk~     test. On the second day each patient performs the test that was not performed on the first~     day. All walk tests are performed by the same investigator on the same track and time of~     day, following the 2002 guidelines of the American Thoracic Society.~      Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen~     saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of~     perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are~     recorded at rest after 10 minutes of sitting.~   "
45432|NCT02462330|"~     Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type~     and delivery method remain to be determined. Pre-clinical studies demonstrated improvement~     of cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine~     and immunosuppressive properties. Investigators initiated the MESAMI program by the~     bicentric pilot phase and highlighted the safety and feasibility of intramyocardial~     injections of MSCs from bone marrow in patients with chronic ischemic cardiomyopathy and~     left ventricular dysfunction, guide by the NOGA-XP system. The MESAMI program continues with~     the phase 2, multicenter, double-blind, randomized, placebo-controlled trial.The aim of this~     phase 2 study is to demonstrate a functional improvement, measuring peak VO2, at 3 months~     between the cell therapy group and the placebo group.~   "
45433|NCT02462317|"~     Stroke is the first cause of motor impairment and disability in adults. Then the main~     objective of rehabilitation during the first six months following stroke is to facilitate~     motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an~     increase of disability. Then antispastic drugs are frequently prescribed to the patients~     even during the post-stroke recovery phase. Until recently most of french patients were~     treated by oral tablets of baclofen. Now the number of patients receiving intramuscular~     injections of botulinum A toxin is increasing. However in the literature, these drugs have~     been tested in post-stroke spasticity during the chronicle phase, after the sixth month and~     their action on motor recovery remain largely unknown. Then it is necessary to evaluate more~     accurately the effects of its drugs on motor recovery. The main criterion of its study is~     the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke,~     since less than two months, will be included in the try. They receive at the same time oral~     tablets for five months and intramuscular injections. Patients are randomized in three arms~     planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum~     toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120~     patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be~     assessed before treatment start, one month and three months later. Spasticity, functional~     abilities, capacity in the activities of daily life, pain and quality of life will be also~     assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel~     index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index~     respectively. A positive difference of 12 points in the time course of FMA in the botulinum~     toxin group in comparison with the baclofen group will be considered as the minimum relevant~     effect. 300 patients have been planned to be included in 20 centers during the 2 years of~     trial.~   "
45434|NCT02462304|"~     Objectives:~      To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor~     (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth~     Factor and end-point-management grid laser photocoagulation for diabetic macular edema.~      Study design:~      Open-label non-randomized interventional study.~      Study overview:~      This study aims to look at the efficacy of treating diabetic macular edema (DME) with either~     anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination~     therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a~     period of 6 months.~      Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending~     on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy'~     arm, or to the 'Combination therapy' arm.~   "
45435|NCT02462291|"~     Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of~     disability with elevated social costs. Alternative solutions to the standard pharmacological~     therapies have been studied in order to reduce the use of medications that frequently~     generates side effects and worsen patients' quality of life. A recent alternative treatment~     for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic~     gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this~     approach is still mater of debate. Therefore, the aim of this trial will be to analyze the~     effects of EET, in people with severe AD.~   "
45436|NCT02462278|"~     This study evaluates the safety and usability of a continuous temperature sensor for women.~     Data will compare the date of ovulation identified by the continuous temperature sensor to~     that of transvaginal ultrasound and serum progesterone levels. Subjects will also compare~     sensor results to once-daily oral temperatures and urine luteinizing hormone (LH) status.~   "
45437|NCT02462265|"~     The study will be a prospective open-label single-center study in previously treated~     patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment~     efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R~     (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R~     were shown to have anti-tumor activity and good safety profile.~      Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage~     chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to~     multiple dose regimens of Oshadi D and Oshadi R.~      Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post~     therapy initiation.~   "
45438|NCT02462252|"~     An open label single arm study to assess efficacy and safety of BL-8040 on top of standard~     immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS~     and AA over the course of a six month (180 day) treatment period.~   "
45439|NCT02462239|"~     Bladder cancer is the fifth most common cancer in Canada and there has been relatively~     little progress in altering its clinical course over the last three decades. One of the~     major problems identified in the management of this disease, is under staging of muscle~     invasive disease which can lead to suboptimal treatment and outcomes. PET-CT has the~     potential to more accurately stage MIBC than standard CT by detecting pelvic adenopathy~     and/or distant sites of disease that may not be found on standard imaging. In the former~     situation, more aggressive therapy with extended lymph node dissection and/or neoadjuvant~     chemotherapy prior to cystectomy can be offered. While in the latter situation patients can~     be spared the morbidity of a cystectomy performed in a setting of metastatic disease. This~     study will address whether PET-CT adds a clinically meaningful difference in care.~   "
45465|NCT02461901|"~     This study evaluates whether patients with Clostridium difficile infection (CDI) who are~     treated with fidaxomicin have less contamination of their skin and surrounding environment~     with spores of C. difficile than patients treated with other drugs (metronidazole or~     vancomycin)~   "
45440|NCT02462226|"~     The purpose of this research study is to conduct a randomized clinical trial to evaluate the~     efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and~     symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary~     outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index,~     quality of life related to pain.~      Recruitment includes 120 patients who will be randomized according to pain/aching/soreness,~     and tenderness. Participants in the intervention group will be provided the web-based~     The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program~     during the 1-4 weeks of the study. Participants in the control group will receive the~     web-based arm precaution program. All the participants will have monthly online assessment~     of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research~     visits, that is, prior to intervention and 12 weeks post-intervention.~   "
45441|NCT02462213|"~     Cardiac amyloidosis describes a process by which abnormally folded proteins infiltrate the~     heart tissue. Given the insidious nature of this disease process, diagnosis is often too~     late for a meaningful intervention. Advances in the treatment of the amyloidoses have~     improved outcomes for patients with these conditions. The focus of this study is to identify~     the involvement of the heart, most closely associated with mortality, so that aggressive~     management can be instituted improving prognosis.~   "
45442|NCT02462200|"~     The investigators propose a randomized controlled superiority trial of standard~     breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main~     objectives of this trial will be to evaluate prospectively the impact of routine~     standardized CSM on margin status following primary surgery for early stage breast cancer~     (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general~     intraoperative time and operative costs. A parallel group format will be implemented to~     compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current~     standard of care.~   "
45443|NCT02462187|"~     This is a randomized, double-blind, vehicle-controlled, ascending dose study to assess~     safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects~     with external genital and perianal warts. Eligible subjects will be treated with a topical~     gel (active or vehicle) for up to 12 weeks.~   "
45444|NCT02462174|"~     To find alternatives to caudal analgesia that could be more safe and effective and to~     demonstrate the analgesic efficacy of topical ketamine.~   "
45445|NCT02462161|"~     This pilot clinical trial will examine the effects of intranasal insulin aspart on~     cognition, daily function, blood and CSF markers of Alzheimer's disease, and amyloid~     deposition in the brain. Participants will be randomly assigned to receive insulin aspart or~     placebo during a 12-week treatment period.~   "
45446|NCT02462148|"~     This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve~     blocks.~   "
45447|NCT02462135|"~     This study sought to investigate the changes in objective memory performance (including~     immediate recall and delayed recall), subjective memory complaints and degree of depression~     in older adults with mild cognitive impairment after Virtual interactive memory training~     (VIMT).~   "
45448|NCT02462122|"~     Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis~   "
45449|NCT02462109|"~     Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and~     adolescents mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to~     overlap. The researchers' objectives in this study were to investigate the presence and~     types of catatonic symptoms in children with Nodding Syndrome and observe their response to~     one or two doses of lorazepam, the first-line treatment for catatonia.~   "
45450|NCT02462096|"~     This study is designed to evaluate the safety and technical feasibility of the ReLeaf~     Catheter System in the creation of one or more tissue leaflets in the femoral and/or~     popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry~     criteria.~   "
45451|NCT02462083|"~     The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.~   "
45452|NCT02462070|"~     The objective of the study is to evaluate the safety and efficacy of a topical lotion.~   "
45453|NCT02462057|"~     The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage~     healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled~     in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy~     foods they purchase at selected grocers. And, while overall enrollment in the program is~     high, there is particular interest in increasing enrollment in the benefit amongst Vitality~     members with diabetes. One presumed barrier to enrollment in the benefit amongst members~     with diabetes is a misperception of the particular relevance of the benefit and healthier~     food choices for their personal health. Improved messaging regarding the HealthyFood benefit~     and its particular salience for individuals with diabetes may be an effective means of~     increasing activation of the benefit in this population. The proposed study will be a~     collaboration between Discovery Health/Vitality and researchers at the Perelman School of~     Medicine at the University of Pennsylvania. In the proposed RCT, Vitality members with~     diabetes will be randomised to different types of messages regarding the HealthyFood~     benefit. The investigators will then compare the effectiveness of these different messaging~     strategies at increasing activation of the HealthyFood benefit amongst Vitality members with~     diabetes.~   "
45454|NCT02462044|"~     Computed tomographic angiography (CTA) is an important prognostic tool with regard to the~     detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine~     delivered to the patient per second) and iodine concentration are decisive factors in the~     opacification of arterial vessels.~      There remains to be some debate in the literature about whether the use of high iodine~     concentration contrast media is beneficial compared to lower iodine concentrations.~      To date, there have not been any studies comparing intracoronary attenuation using~     concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable~     comparison of CM with different iodine concentrations, adapted injection protocols insuring~     an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that~     usage of lower iodine concentrations, while maintaining identical IDR and total iodine load,~     will result in comparable diagnostical intra-vascular attenuation in CTA.~   "
45455|NCT02462031|"~     To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral~     dosing in the fed state in obese or overweight subjects.~   "
45456|NCT02462018|"~     Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from~     a non-progressive injury during early brain development which leads to impairment of~     movement and posture.~      Muscle weakness and spasticity associated with CP limit the joint range of motion and~     negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with~     ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle~     range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle~     weakness and atrophy.~      During the last years a novel method is being used for treating upper motor neuron drop~     foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).~      These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and~     activating the tibialis anterior muscle. Most of the studies of FES devices were conducted~     on adult population. These studies showed improvement in laboratory and functional gait~     parameters. There are relatively few studies on children with hemiplegic or diplegic CP with~     favorable results. There is no solid evidence whether the improvements seen in laboratory~     setting of children with CP, are reflected on functional ambulation in daily life. In~     addition, there are no defined parameters which could predict the response to FES among~     those children.~      The aim of this study is to determine whether using FES device (WalkAide; Innovative~     Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children~     with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and~     biomechanical parameters that can predict a favorable response to using the FES device.~   "
45457|NCT02462005|"~     A total of up to 250 patients from an all-comers patient population with infrainguinal~     atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug~     coated balloon.~      Interim analysis will be carried out for every 50 subjects enrolled.~   "
45458|NCT02461992|"~     An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC),~     Recombinant Factor VIII) in male Chinese subjects with hemophilia A~   "
45459|NCT02461979|"~     Previous data have suggested that vitamin D levels may influence cancer development. In~     particular, several single nucleotide polymorphisms have been described in the Vitamin D~     receptor( VDR gene), and some polymorphisms are associated with tumor occurrence. For~     instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin,~     colon-rectum, bladder and kidney, although with conflicting observations . VDR polymorphisms~     have also been investigated in the context of some chronic liver diseases, such as chronic~     hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published~     study, VDR polymorphism may be used as a molecular marker to predict the risk and to~     evaluate the disease severity of HCC in patients with chronic hepatitis B.~      A significant association of VDR (ApaI) polymorphism with the development of HCC in chronic~     HCV infection may help to identify those who are at high risk of developing HCC.~   "
45460|NCT02461966|"~     Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the~     blend of risk factors differs in different parts of the world, and this may explain in part~     the diverse biologic characteristics of HCC in different populations .~      Exposure to aflatoxin is an additional risk factor for the development of HCC, through~     damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study~     showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .~      Clinical studies have shown that AFB1 selectively targets at the third base position of~     codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular~     carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been~     reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral~     hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies.~      Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C~     (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to~     ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .~   "
45461|NCT02461953|"~     This study is a prospective, randomized, controlled multicenter clinical study. The aim of~     the study is to investigate whether the combination of maintenance hemodialysis (MHD) with~     hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic~     toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.~   "
45462|NCT02461940|"~     A randomized controlled trial conducted on 688 sexually experienced adolescents, with 337~     participants assigned to the routine program, and 351 to the new intervention developed from~     an assessment of their needs. All participants will complete a self-administered~     questionnaire and an interview on their knowledge of sexually transmitted infections~     (STIs)/Human Immunodeficiency Virus (HIV), self-efficacy, skills in negotiating for sexual~     abstinence or condom use, and sexual behaviors at baseline and at 6- and 12-months' post-~     intervention. All will be tested for STIs. Participants in the intervention group will~     receive 4 individual counseling sessions on STIs/HIV knowledge, life skills, secondary~     abstinence, safer sex and healthy relationships over 1 year. They will also be referred to~     counselors for proactive social and emotional support delivered through electronic media and~     other means. The control group will receive the usual counseling session at first and~     follow-up clinic visit.~   "
45463|NCT02461927|"~     The investigators propose an 8-week, randomized, double-blind, placebo-controlled,~     between-subjects trial in which repeated ketamine treatment (0.5 mg/kg; once a week for 4~     weeks; a total of 4 ketamine infusions) will be evaluated for safety and efficacy. First,~     prior to the double-blind trial, the investigators will conduct an open-label trial that~     will include 5 patients with comorbid major depressive disorder (MDD) and alcohol use~     disorder (AUD) to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a~     week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second,~     after reviewing the safety and efficacy of repeated ketamine treatment from the open-label~     trial, the investigators will conduct an 8-week, randomized, double-blind,~     placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test~     safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a~     total of 4 ketamine infusions) with a follow-up of 4 weeks.~   "
45464|NCT02461914|"~     To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy~     subjects.To provide a scientific basis for clinical drug combination of PEX168.~      To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin~     in healthy subjects.~      To assess the safety of single doses of warfarin administered with and without PEX168~   "
45469|NCT02461849|"~     KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series~     of downstream effector pathways. KIT is an established therapeutic target in cancer with~     activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant~     benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate.~     Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic~     targets in melanoma. Additional information is required to characterize the functional role~     of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is~     a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid~     cancers were reported to have KIT mutation even in low frequency. A molecular profiling of~     the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center~     showed KIT mutation in 7 patients in total of 431 patients (2%).~      Hence, the investigators planned this study to apply the molecularly targeted agent,~     imatinib to various types of cancers harboring KIT mutation or amplification.~   "
45470|NCT02461836|"~     Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is~     the only curable method to treat pancreatic cancer. However, even if radical resection is~     achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported~     adjuvant radiation can prolong survival and improve quality of life after surgery. For R0~     (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value~     of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant~     radiation for patients after radical resection of pancreatic cancer with advanced stages (T3~     or N1) in large, prospective, and randomized cohorts.~      The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful~     and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with~     advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of~     care for pancreatic cancer patients.~   "
45471|NCT02461823|"~     Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on~     periodontal health.~   "
45472|NCT02461810|"~     The purpose of this study is to compare the safety and effectiveness of the SpineJack® with~     the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of~     SpineJack® VCF treatment system versus Balloon Kyphoplasty.~   "
45473|NCT02461797|"~     Recently, a critical role in the development of allergic rhinitis (AR) has been attributed~     to the nasal epithelium. The airway epithelium forms a physical barrier, protecting the~     nasal mucosa and underlying organs from damage from contact with exogenous particles. The~     nasal epithelial barrier is primarily determined by the integrity of the airway epithelium,~     in which epithelial cells are connected to each other by complex network structures like~     tight junctions (TJs), ultimately sealing off the paracellular space. TJs consist of~     different transmembrane proteins including occludin, tricellulin, the claudin family, and~     junctional adhesion molecules. TJ form intercellular homodimers/heterodimers between~     neighboring cells. Scaffold adaptor proteins like cingulin and the zonula occludens family~     connect the transmembrane proteins to the actin cytoskeleton.~      Disturbed TJ function can facilitate the entrance of foreign pathogens and antigens into the~     submucosal layer, giving raise to allergic sensitization via increased access of allergens~     to the dendritic cells and/or inducing persistent inflammation via activation of mast cells~     and other inflammatory cells residing in the upper airways. Chronic disorders like allergic~     asthma, inflammatory bowel disease and atopic dermatitis have been linked to defective or~     altered TJ function. Recently, an impaired epithelial barrier function was found in patients~     with chronic rhinosinusitis with nasal polyps (CRSwNP), suggesting changes in TJ arrangement~     in the nasal cavity. CRSwNP presents a similar inflammation of the sinonasal cavities as~     found in AR patients, i.e. a Th2 cytokine driven inflammation with tissue eosinophilia.~     Nevertheless, the role of TJs and its regulation has not been investigated in AR.~   "
45474|NCT02461784|"~     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal~     tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in~     incidence (rate or frequency) during the reproductive years. An increasing number of young~     people will face challenging decisions regarding medical management of this chronic disease~     during a period of time when they are still completing schooling, establishing their career,~     and/or are building a family.~      Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators~     (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance~     that interferes with or inhibits the action of another). It is thought that MTX works by~     decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many~     years and in used as treatment in not only IBD, but also in conditions such as rheumatoid~     arthritis and lupus. However, due to concerns about the safety of MTX, particularly in~     regards to fertility and pregnancy has limited its current use.~      Participants are invited to take part in this research project to determine whether the~     treatment of IBD patients with MTX is associated with an increased risk for infertility.~     Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as~     75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital~     & Clinics.~   "
45475|NCT02461771|"~     The objective of this study is to provide initial safety, tolerability and pharmacokinetics~     information of intravitreal administration of APL-2 in order to support further development~     into larger Phase II studies for treatment of patients with AMD.~   "
45486|NCT02461628|"~     The overall objective of this study is to evaluate the public health impact of targeted~     antimalarials subsidies through scale-up by determining the community-wide effects of~     targeting an antimalarial subsidy through a partnership between Community Health Volunteers~     (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a~     fixed-price voucher that reduces the cost for ACT purchase in the retail sector conditional~     on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and~     will increase the proportion of fevers tested for malaria before treatment. The study will~     be carried out in two sub-counties in Kenya with similar malaria burden but different access~     to health services; the investigators will use a cluster-randomized design to assign~     community units (CUs) in each sub-county to either an intervention or control arm. CHVs will~     be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household~     members with documented or reported fever; households in intervention CUs will be informed~     of the intervention and encouraged to contact the CHV for any febrile illness in the home.~     There are minimal risks associated with receiving an RDT. Households with a positive RDT~     will be given a serialized voucher that will entitle the holder to purchase a quality~     assured ACT in the retail sector at a reduced, fixed price. The primary and secondary~     outcome measures will be compared at baseline and 12 months post-baseline through~     population-based surveying. Population-based surveying conducted at 6 months and 18 months~     post-baseline will provide additional information. The primary aim is to determine whether~     there is significant difference between the 2 study arms in the proportion of clients with~     fever who are tested prior to any treatment after adjusting for relevant covariates.~   "
45476|NCT02461758|"~     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal~     tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent~     epidemiological investigation estimates that nearly 4 million people worldwide are affected~     and approximately 1.4 million of these cases occur in the United States. IBD can lead to~     debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures~     and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic~     corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as~     tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can~     achieve clinical remission and decrease the risk of complications, but also increase the~     risk for opportunistic infections, including influenza.~      Multiple studies have shown lower influenza vaccine responses in patients with IBD compared~     to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF~     inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza~     serum antibody concentration correlates with protection from infection following~     vaccination. Therefore, increasing influenza antibody responses in patients with IBD would~     appear to be critical to improving protection from influenza. A high dose (HD) influenza~     vaccine containing four times more hemagglutinin was licensed based on its ability to induce~     higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.~   "
45477|NCT02461745|"~     This is a Phase IV, open-label, multi-center study to evaluate the real world sustained~     virological response rate, subject adherence, and subject reported outcomes during and after~     treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,~     with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasubuvir), with or without ribavirin.~   "
45478|NCT02461732|"~     The purpose of the study is to determine whether a novel integrated cognitive-behavioral~     treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment~     for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than~     cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms~     and substance use quantity and frequency.~   "
45479|NCT02461719|"~     The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic~     nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group~     12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and~     safety in Moderate to Severe Dry Eye Disease.~   "
45480|NCT02461706|"~     The main goal of this study is to provide treatment with cannabidiol (CBD) to children with~     drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol.~     As the controlled therapeutic use of CBD in children is novel, the primary objective of this~     study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy~     in children that have exhausted the majority of FDA approved antiepileptic drug treatment~     options.~   "
45481|NCT02461693|"~     The purpose of this project is to examine the effect of expectancy on mood and alertness~     after consumption of caffeine treatment or placebo control pill, given that participants~     know their probability for receiving the caffeine versus placebo pill. Participants will be~     randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and~     this probability will be revealed to them before consumption of the assigned pill and~     subsequent cognitive testing. At the time of consumption, neither study staff administering~     the intervention nor participants will know for certain which pill is given to each~     participant. Pill assignment will depend on pre-determined randomization probabilities,~     which will be provided and assigned by the study statistician. By revealing participants'~     individual probability of receiving the caffeine pill, we will induce positive or negative~     expectancies regarding likelihood for receipt of the caffeine pill. These experimental~     manipulations will: 1) estimate the effect of expectancy on cognitive and affective~     outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under~     real-world conditions than would a conventional randomized trial.~   "
45482|NCT02461680|"~     Flexors tendon injuries are frequent and serious with a potential of definitive functional~     aftereffects. In the case of partial injury, the treatment is debated. There are 2~     techniques of possible repair, the direct suture and the tangential resection. The~     investigators have already demonstrated that this last technique was favorable for injuries~     going to 50 %. In the case of partial section between 50 and 75 %, the investigators think~     that the technique of tangential resection compared with the direct suture would not~     increase the risks of secondary breaks, would authorize even an immediate mobilization and~     would decrease the secondary complications.~      The main objective is to highlight that the tangential resection is not lower than the~     classic technique on the clinical plan The secondary objectives are to highlight the~     non-inferiority of the tangential technique in clinical terms (pains, dexterity,~     complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures~     and professional activities)~   "
45483|NCT02461667|"~     This is a 9 month randomised controlled clinical comparing the clinical efficacy of~     1%metformin and 1%alendronate in chronic periodontitis subjects.~   "
45484|NCT02461654|"~     In this prospective observational trial the effect of the Disc FX microinvasive therapy~     should be examined in (approximately 150) adult patients with low back pain.~   "
45485|NCT02461641|"~     This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and~     complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity~     compared to standard care alone.~   "
45487|NCT02461615|"~     The major goal of this study is to establish a National PAP Registry to help make reliable~     new research tests available to doctors to improve the diagnosis of PAP, increase awareness~     and knowledge of PAP, and give patients a 'seat at the table' in planning and conducting PAP~     research including the clinical testing of several new potential therapies.~   "
45488|NCT02461602|"~     ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial~     Fibrillation Patients) is a two year research project to assess warfarin management issues~     faced by atrial fibrillation (AF) patients in ambulatory settings.~   "
45489|NCT02461589|"~     This trial is conducted globally. The aim of this trial is to investigate dose-finding of~     semaglutide administered subcutaneously once daily versus placebo and liraglutide in~     subjects with type 2 diabetes.~   "
45491|NCT02461563|"~     This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to~     suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose~     administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and~     well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL)~     reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral~     administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected~     participants.~   "
45492|NCT02461550|"~     The investigators are investigating the use of a new cancer treatment called Irreversible~     Electroporation (IRE). This treatment delivers electrical energy between two needles placed~     in a cancer. The electrical energy causes cells to die. While this has been used in patients~     for different applications, the investigators are trying to understand how safe and well it~     works in colon cancer that has spread to the lung. Once the irreversible electroporation~     procedure is completed during the operation, the surgeon will then remove the cancer~     according to standard procedure. As part of the study, they will be measuring safety of the~     electrical energy delivered and will be reviewing the resected specimen under the~     microscope.~   "
45493|NCT02461537|"~     This trial compares outcome of two treatment strategies for patients with high-risk AML who~     failed to achieve or maintain a complete remission with standard therapy. Patients will be~     randomized between two strategies. The standard strategy is aimed at achieving a complete~     remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, .~     The alternative is a less toxic disease-control strategy of disease monitoring and, if~     necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which~     should be performed as soon as possible.~   "
45494|NCT02461524|"~     The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo~     AAA (Abdominal Aortic Aneurysm) Stent graft system for endovascular treatment of subjects~     with infrarenal abdominal aortic or aortoiliac aneurysms.~   "
45495|NCT02461511|"~     To Assess the impact of therapeutic education on:~        -  the occurrence of long term diabetes complications .~        -  balance of his diabetes~   "
45496|NCT02461498|"~     Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing~     patients taking warfarin after a blunt head injury is variable with little research that~     supports the most appropriate way to manage these patients. The investigators aimed to~     undertake research in order to understand the range and frequency of outcomes following head~     injury in this group of patients and to develop robust clinical guidance for how they should~     be optimally managed in the future.~   "
45497|NCT02461485|"~     First experimental study (Proof Of Concept) to investigate bowel function parameters on~     which a fermented milk product with probiotics alone or in association with fibers has a~     potential effect.~   "
45498|NCT02461472|"~     A large-scale, community-based, cross-sectional study was conducted to explore the extent to~     which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in~     general Chinese population. A total of more than 2000 diabetic participants were recruited~     by using multiple stages sampling (first cluster sampling and then simply sampling). Data~     involved in demographic information, clinical biomarkers such as glucose and lipids~     profiles, medical and therapy history were collected. Every participants was complete DNA~     extracted and genotyped. Diabetic Cardiovascular autonomic functions were measured by using~     short-term heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and~     multiple variables analysis have been performed to examine potential environmental and~     genetic risk factors of CAN. In addition, clinical risk model, simply screening model and~     nonlinear system model such as artificial neural network was created, respectively.~   "
45499|NCT02461459|"~     The purpose of this study is to characterize the developmental phenotype of ASD and ID and~     identify biomarkers using advanced MRI methodology predictive of ASD and ID presence and~     severity in pediatric patients with TSC. In addition, this study will be establishing~     infrastructure for the collection and storage of human bio-specimens, including genetic~     material, from TSC patients and their family members with ASD.~   "
45500|NCT02461446|"~     The purpose of this study is to determine cross-sectional and longitudinal medical,~     behavioral, and cognitive differences between PTEN ASD and other groups, as well as to~     identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In~     addition, this study will be creating and maintaining a biorepository and linked phenotypic~     database for PTEN ASD.~   "
45501|NCT02461433|"~     The purpose of this study is to determine whether application of an incisional wound Prevena~     trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30)~     surgical patient will reduce surgical site infections (SSI) when compared to the standard of~     care dressing.~   "
45502|NCT02461420|"~     The purpose of this study is to comprehensively characterize PMS using standardized medical,~     cognitive, and behavioral measures and to track the natural history of the syndrome using~     repeated longitudinal assessments. In addition, this study will be aiming to identify~     biomarkers using neuroimaging, including difusion tensor imaging and identify genetic~     factors which contribute to diverse phenotypes in patients with PMS.~   "
45503|NCT02461407|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with Gastric Cancer.~   "
45504|NCT02461394|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care),~     Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch~     Select Simple (LifeScan) following ISO 15197:2013, clause 8.~      The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed~     by study personnel (with the same reagent system lot used by subjects).~   "
45529|NCT02461056|"~     Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the~     co-administration with opioids. The investigators searched whether intravenous~     ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on~     postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.~   "
45505|NCT02461381|"~     This study aimed to estimate sensitivities and specificities of diabetic cardiovascular~     autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold~     standard in another independence dataset.The reference the values for the short-term HRV~     were calculated in the investigators' previous study (including 371 healthy subjects). This~     study dataset contained 200 diabetic patients who completed both the short-term HRV test and~     Ewing's test. Simultaneous inferences about the population prevalence and the performance of~     each diagnostic test were possible using the Bayesian approach without a gold standard.~   "
45506|NCT02461368|"~     The investigators compared the results of the ultrasound-guided anterior and posterior~     approaches to administer glenohumeral steroid injections to patients with primary adhesive~     capsulitis of the shoulder joint by a single experienced provider.~   "
45507|NCT02461355|"~     This is a randomized, crossover design trial that will compare how anodal transcranial~     direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of~     scripting therapy affects the acquisition and retention of trained scripts.~   "
45508|NCT02461342|"~     A large-scale, community-based, cross-sectional study was conducted to explore the extent to~     which genetic, environment and its interactions associated with cardiovascular autonomic~     neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were~     recruited by using multiple stages sampling (first cluster sampling and then simply~     sampling). Data involved in variables of genetic, environment were collected. Every~     participants was complete DNA extracted and genotyped by using single nucleotide~     polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term~     heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed~     to evaluate genetic variants, environmental risk factors and its interactions for CAN.~   "
45509|NCT02461329|"~     The purpose of the study is to determine whether volume therapy with a solution of gelatine~     has negative impact on coagulation, platelet function, renal function in comparison with~     crystaloid solution (Ringerfundin).~   "
45510|NCT02461316|"~     Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with~     chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic~     Leukemia (CLL).~   "
45511|NCT02461303|"~     Klinefelter syndrome is characterized by primary testicular failure and progressive~     infertility. The objective of this study is to determine if sperm are present and can be~     observed in urine and semen samples of adolescent and young adult Klinefelter patients and~     to determine whether the presence of sperm correlates with physical and/or clinically~     obtained hormone measures of pubertal development.~      This study was designed in order to answer the following questions:~        1. Is it possible to observe sperm in urine samples of adolescent and young adult~          Klinefelter patients?~        2. Is it possible to retrieve sperm for cryopreservation from semen samples of adolescent~          and young adult Klinefelter patients?~        3. Does the presence of sperm correlate with the physical and/or endocrine measures that~          are assessed during routine clinical evaluations of pubertal development in the KS~          patient population?~        4. If sperm retrieval is possible, what is the optimal age at which sperm retrieval should~          be attempted?~   "
45512|NCT02461290|"~     The primary objective is to evaluate the safety profile and tolerability of rituximab in~     combination with different chemotherapy regimens.~   "
45513|NCT02461277|"~     The aim of this study was to compare the functional capacity of exercise by six-minute walk~     test before and after thoracic surgical procedure in subjects who have undergone the~     Fast-track protocol with those who were under conventional care. Researchers want to find~     out if Fast-track is a strategy to enhance functional capacity after thoracic surgery.~   "
45514|NCT02461264|"~     Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic~     stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit~     hematology require compensation of anemia and thrombocytopenia by blood transfusions of red~     blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de~     Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to~     transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g /~     dL. These recommendations allow to transfuse a single RBP for very elderly patients or in~     cases of associated heart disease (heart failure). A recent development (2012) on~     post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk~     patients.~      More recently, a Swiss team has historically compared transfusion policies in 2 139 patients~     with hematological malignancies. The first group received 2 RBP transfusion in case of~     symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at~     each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP~     transfusion policy has resulted in a 25% decrease in the number of RBP used without any~     complication. In a prospective single-center pilot study, we showed that transfusing a~     single RBP was possible without increasing the side effects of anemia, without complications~     and allow an overall reduction in consumption of red blood cell units.~      Several meta-analyzes reported in intensive care or bleeding situations that a restrictive~     use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and~     mortality. The number of patient to be treated to prevent one death is 33.~      The main objective is to demonstrate in a randomized trial that the restrictive strategy~     (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy~     (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are~     performed in case of hemoglobin level <8g/dL.~      Key secondary objectives are to reduce the number of RBP used and the cost of~     hospitalization with a comparison of complications/mortality in the 2 groups.~   "
45515|NCT02461251|"~     This is a prospective, randomized and controlled study to find out if a rotational~     thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions~     in major obstetric haemorrhage compared to standard care of clinical decision making,~     conventional coagulation tests and massive transfusion protocol. Secondary aim is to find~     out if ROTEM can predict the incidence of thromboembolic events in this patient group.~   "
45516|NCT02461238|"~     The purpose of this study is to assess whether fruit and vegetables vouchers combined with~     educational support may increase fruits and vegetables consumption of children aged 3 to 10~     living in vulnerable families in Saint-Denis, France.~   "
45517|NCT02461212|"~     The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done~     in a MRI) can accurately detect the amount of fat in the liver.~   "
45530|NCT02461043|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients~          with regional lymph node metastases have worse outcome than those without lymph node~          metastases.~        -  No standard postoperative adjuvant chemotherapy has ever been established.~   "
45531|NCT02461030|"~     This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of~     dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a~     period of 8 weeks.~   "
45518|NCT02461199|"~     During this prospective observational study, the investigators collect the information about~     the outcomes of fecal microbiota transplantation in patients with blood disorders, performed~     to eradicate gut colonization with multidrug-resistant (MDR) bacteria.~      Patients with blood disorders are characterized by poor diversity of gut microbiome,~     affected by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable~     to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance.~     In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may~     cause severe systemic infections. As the bacteria are secreted with the stool, the colonized~     patients become an epidemiologic threat to the others.~      Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of~     relapsed and refractory Clostridium difficile infection and became a standard treatment. In~     home institution, the investigators use FMT not only in case of Clostridium difficile~     colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This~     is based on assumption that physiological gut flora may outcompete the pathogenic bacteria~     similarly as in case of Clostridium difficile and lead to loss of colonization. The~     procedure is performed in all patients colonized, who qualify according to listed inclusion~     and exclusion criteria .~   "
45519|NCT02461186|"~     Emerging resistance to artemisinins and their partner drugs severely threatens the treatment~     of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug~     policy, it is crucial to evaluate alternative antimalarial treatments.~      The investigators here propose a randomized clinical trial comparing parasite clearance~     parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days~     dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria~     in Myanmar stratified for the presence of K13 mutation in the infecting parasite strains.~   "
45520|NCT02461173|"~     Four hundred and fifty women with unexplained infertility will be divided into 3 equal~     groups using computer generated random numbers: Group 1 will have up to 4 stimulated IUI~     cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant~     after the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the~     expected time of ovulation. Group 3 will be the control group will be advised to have~     regular sexual intercourse at the time of ovulation for 6 months~   "
45521|NCT02461160|"~     The purpose of this study is to characterize the safety, tolerability and plasma~     pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral~     suspension doses at escalating dose levels in healthy participants, including elderly~     participants.~   "
45522|NCT02461147|"~     Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has~     been implemented at the investigators institution as the standard management strategy for~     patients at intermediate risk of common bile duct stone migration, following a randomized~     controlled trial previously published by the same investigators team. The aim of this study~     is to prospectively analyze the outcomes of this strategy.~   "
45523|NCT02461134|"~     Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person~     (the host) who has received cells or organs (graft) from another person because the graft~     attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the~     USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes~     (a type of white blood cells) are likely to play a role in the development of chronic GVHD.~     Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a~     new therapeutic approach to treat chroninc GVHD.~      The main objective of this study is to assess the effectiveness and safety of several doses~     of ponesimod in subjects with chronic GVHD who did not respond to standard available~     treatments.~   "
45524|NCT02461121|"~     Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is~     assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is~     assigned to receive MST therapy without GVHD prophylaxis.~   "
45525|NCT02461108|"~     The investigators hypothesize that monetary incentives and messaging, such as making~     nutritious foods relatively less expensive than less nutritious foods and framing the price~     difference in a positive or negative way, will influence purchasing behavior of households.~   "
45526|NCT02461095|"~     Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower~     extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been~     identified as an important factor in patients with PFPS. The authors hypothesize that an~     ordered approach addressing each of these impairments sequentially will result in greater~     improvement in PFPS symptoms. The results of the investigators pilot study assessing the~     feasibility of using a sequential approach showed a full randomized controlled trial is~     warranted, the authors now plan to proceed with a full trial. The objective of this study is~     to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain~     Syndrome.~      Methods: Patients will be randomized to a sequential treatment approach using a PFPS~     treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy~     care. Due to the constant evaluation necessary no blinding will be performed. Patients will~     attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and~     Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month~     follow-up and 6 month follow-up.~   "
45527|NCT02461082|"~     The purpose of the study is to examine the effectiveness of different methods for the~     treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from~     PD develop dysphagia during the course of their disease leading to malnutrition, loss of~     life quality, weight loss and pneumonia, which is the leading cause of death in these~     patients. So far, only a few specific treatment approaches have been investigated in PD~     patients with swallowing disorders. The investigator want to compare a 4-week expiratory~     muscle strength training (EMST), transcranial magnetic stimulation (TMS), and combination of~     both with a sham therapy. Dysphagia severity before and after intervention is measured by~     flexible endoscopic evaluation of swallowing (FEES). For the evaluation of changes in~     cortical swallowing processing the investigators apply magnetoencephalography (MEG).~   "
45528|NCT02461069|"~     This is an exploratory study, which allows analysis of multiple immune parameters derived~     from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting~     multiple sclerosis before and during immune-modulatory treatment with dimethyl fumarate in~     comparison to PBMCs from healthy subjects.~   "
45532|NCT02461017|"~     The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed~     assessment to verify appropriate tube size in neonates, infants and children. However, many~     factors are known to influence the audible leak test. Even though the test is widely~     performed, the accuracy has not been evaluated.~   "
45533|NCT02461004|"~     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety~     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.~   "
45534|NCT02460991|"~     This is a prospective, multicenter study that will be conducted at up to 40 centers in the~     United States and Outside United States (OUS). Participants in the study will be randomly~     assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the~     study participants' outcomes (medical condition) after being treated with ONCO-DOX and~     compare it to those treated with sorafenib alone.~   "
45535|NCT02460978|"~     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and~     effective therapy to improve glycemic control in patients with type 1 diabetes.~   "
45536|NCT02460965|"~     Rationale: Hallucinations occur in many patients with different kinds of diseases, including~     psychiatric, neurological and perceptual impairment. The origin of these hallucinations is~     only partly understood. This prevents correct prediction of treatment response and hampers~     the development of new, more effective treatment strategies.~      Different subtypes of hallucinations resulting from different neuropathology may exist~     across diagnostic entities, and be responsive to different treatment strategies.~     Understanding the origin of these subtypes with use of fMRI and EEG can help to make~     rational treatment decisions on an individual basis and enhance the development of~     innovative treatment paradigms.~      Objective: The primary objective is to find specific abnormalities on resting state fMRI~     related to the pathophysiology of different subtypes of hallucinations. Secondary objectives~     are to find EEG connectivity measures that are related to the pathophysiology of different~     subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the~     experience of hallucinations across different disorders, and to examine the frequency of~     spontaneous synchronized burst activations in auditory and visual cortices using fMRI.~      Study design: The investigators intend to examine neural correlates of hallucinations over~     different disorders using resting state EEG, fMRI and sMRI in an observational study.~      Study population: A total of 140 hallucinating patients will be included, 20 of each of the~     7 different diagnostic groups. As a control group, 140 non-hallucinating patients with the~     same disorder of similar severity will be included.~      Main study parameters/endpoints: The main study endpoint is the difference in resting state~     correlates as measured with fMRI between hallucinating and non-hallucinating participants~     and between hallucinating individuals of different subtypes, namely: connectivity within the~     DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG~     measurement of 5 minutes. Total visit time, including preparations, will be approximately~     2,5 hours. The risks associated with participation and the benefits to the individuals are~     negligible. The potential benefit to society in the future is considerable if the findings~     lead to optimization of treatment strategies and treatment response.~   "
45537|NCT02460952|"~     The purpose of this study is to investigate the prevention of Pulmonary Embolism in Patients~     who With General Anesthesia Operation in Perioperative Period.~   "
45538|NCT02460939|"~     The purpose of this study is to investigate the changes of the pulmonary vessel disease and~     its metabolism of small molecules.~   "
45539|NCT02460926|"~     This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment~     performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of~     periodontal disease. The primary aim was to compare the differences in CRP acute increase~     following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included~     changes in a broad array of inflammatory and endothelial injury markers between groups.~     Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical~     periodontal therapy performed within 24 hours induced greater perturbations of systemic~     inflammation compared to conventional treatment.~   "
45540|NCT02460913|"~     Inadequate pain management is a common problem encountered in ED settings. Pain relief~     medications use is often limited by their side effects. Evidence suggests that non~     pharmacologic pain relief techniques such as acupuncture can play a central role to treat~     pain in acute conditions, but their application is still scarce.~   "
45541|NCT02460900|"~     The single greatest health behavior change that could improve cardiovascular morbidity and~     associated mortality is to assist people living with HIV/AIDS who smoke to quit. The~     investigators will use a factorial design to evaluate the most promising behavioral and~     pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among~     people living with HIV/AIDS who smoke. Results of this study will provide crucial, real~     world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS~     quit smoking.~   "
45542|NCT02460887|"~     The purpose of this study is to verify that induction gemcitabine and cisplatin plus~     intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus~     IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).~   "
45543|NCT02460874|"~     Primary Objectives:~      Pilot Portion: To determine the feasibility and safety of administering oral glyburide to~     non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain~     metastases.~      Randomized Portion: To determine the number of patients with newly diagnosed brain~     metastases who have an increase in edema as measured on volumetric FLAIR imaging and the~     number of patients that require dexamethasone administration (or any corticosteroid~     administration with the purpose of treating cerebral edema) from the day of SRS to one month~     follow-up MRI in the group receiving glyburide versus placebo.~   "
45544|NCT02460861|"~     This project is about the detection of occult tumor cells in surgical margins of radical~     prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1~     (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic~     fossa. The biopsies are divided into two parts. One part used for histopathological analysis~     and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor~     stage, Gleason Score and prostate specific antigen (PSA).~      The prostate-cancer-negative control group with bladder cancer.~   "
45545|NCT02460848|"~     Cash transfer, aims to strengthen food security for vulnerable households by giving families~     enough purchasing power to consume an adequate and balanced diet, maintain a good standard~     of hygiene, access health services, and invest in their own means of food production in~     addition to their children's growth and development.~      While cash transfer to vulnerable households has shown a long-term positive impact on growth~     and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive~     evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on~     the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will~     perform a cluster-randomized trial to investigate during 6 months the effects of~     unconditional cash transfers on the management of severe acute malnutrition (SAM) in~     children from 6 to 59 months according to the national protocol in the Democratic Republic~     of Congo.~   "
45546|NCT02460835|"~     This is a pilot single arm study with the primary endpoints of feasibility and preliminary~     estimates of safety and efficacy. This protocol builds on over 25 years of experience with~     high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the~     global radiation dose based on a patient's measured sensitivity to treatment. This current~     protocol uses functional imaging and specialized radiation planning techniques to spare~     highly functional portions of the liver to preserve function. The investigators feel this~     will further improve the safety and efficacy of RT for all patients by customizing~     treatments to each. If this approach is promising, the investigators will proceed to a phase~     II randomized study of standard versus spatially and dosimetrically adapted RT.~   "
45547|NCT02460822|"~     This research project addresses critical gaps in cancer symptom management through the~     creation of a mobile chemotherapy symptom management application. This application will~     assess for the presence and severity of common chemotherapy side-effects and provide~     personally tailored symptom-related video and narratives to enhance self-management of~     cancer and treatment-related symptoms. This study will examine patient acceptance and use of~     this mHealth application (called MyChemoCare) in a prospective trial of cancer patients~     (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan~     Comprehensive Cancer Center.~   "
45548|NCT02460809|"~     This study assesses telerehabilitation in people with chronic stroke using a combination of~     noninvasive brain stimulation and finger tracking training. Telerehabilitation allows~     patients to train in their own home which also allows for longer training periods than what~     is currently allowed clinically. Noninvasive transcranial direct current stimulation (tDCS)~     uses two surface electrodes connected to a small battery that will be attached to the head.~     This will be used to modulate neuronal excitability. With sensors attached to fingers and~     the wrist, the patient will move the joints to track a target displayed on a screen. The~     combined treatment will be applied in two experiments. The first will be on 3 patients~     coming to our lab and the second on 3 patients in their home, both under supervision. We~     will integrate the two components and test the resulting and novel treatment system for~     technical feasibility and safety, which will set the stage for future efficacy studies under~     federal grant support. We hypothesize that the developed system will be safe and feasible.~   "
45549|NCT02460796|"~     BACKGROUND: Motor symptoms associated with Parkinson's disease may impair one's independence~     and ability to perform daily activities consequently decreases quality of life. Hippotherapy~     has been shown as an effective treatment to improve function in daily activities and quality~     of life in other neurological populations, thus a study was conducted to assess the effects~     of hippotherapy in people with Parkinson's disease.~      METHODS: Nine volunteers formed the treatment group which participated in a ten-week~     hippotherapy program, and nine individuals formed the control group (attended a ten-week~     series of lessons on Parkinson's disease). Outcome measures included 30-second chair stand~     (as a measure of strength-endurance), gait velocity (during 10m walk test) and~     health-related quality of life.~   "
45550|NCT02460783|"~     Background:~      - Insulin removes sugar from the blood to use for energy. Insulin resistance means that~     cells may not respond to insulin normally. It can lead to serious diseases. Researchers want~     to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer~     s disease.~      Objectives:~      - To compare two forms of diet and their effects on insulin resistance and the brain.~      Eligibility:~      - Women ages 55 70 with insulin resistance.~      Design:~        -  This study requires 6 clinic visits over 9 12 weeks. Participants must fast before~          visits.~        -  Visit 1, screening:~        -  Medical history, physical exam, and blood and urine tests.~        -  Participants will get a wrist device to wear for 4 days.~        -  Visit 2:~        -  Weight and waist measurement.~        -  Blood drawn.~        -  Questionnaires and thinking tests.~        -  Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back~          will remove <TAB>fluid.~        -  Participants will drink a nutrition shake. Blood will be taken 12 times over 4~          <TAB>hours through a thin tube in <TAB>the arm.~        -  Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a~          strong magnetic field. <TAB>They will have a coil on their head and may do tasks.~        -  Participants will get advice about healthy eating and be randomly put in one of 2~          groups. One group will get <TAB>nutrition shakes to drink.~        -  Visits 3 5:~        -  Weight and waist measurements, vital signs, blood draw, and questionnaires.~        -  Between visits, participants will get a call or email to check how they are doing.~        -  Visit 6: Repeat of visit 1.~        -  Participants will wear the wrist device for 4 more days, have a follow-up contact, then~          the study is finished.~   "
45551|NCT02460770|"~     Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to~     transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy~     and Left Ventricular Assist Device program is to improve heart function with stem cell~     therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.~   "
45552|NCT02460757|"~     In this study the investigators examine the glottic width and the respiratory flow at rest~     in patients with various lung disease. The investigators postulated that a positive~     expiratory pressure is created through the narrowing of the glottic width in patients with~     hyperinflation.~   "
45553|NCT02460744|"~     The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose~     of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast~     conservation in breast cancer patients for the last 4 decades. It is also a routine practice~     in UK and few centers in Canada. Hypofractionation reduces treatment time to half while~     maintaining cosmesis and gives control rates equal to conventional fractionation. As breast~     cancer is a leading cancer in females and radiation therapy is an important part of its~     local management, hypofractionation help the radiation centers worldwide to meet the growing~     need for radiation in breast cancer, particularly in developing countries where resources~     are limited. It also reduces the financial burden on the patient and family.~      In this study the investigators want to reduce the treatment duration from 3 weeks to 2~     weeks. The study will include 20 patients with breast cancer post mastectomy or after breast~     conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2~     weeks. Patients will be assessed for acute radiation toxicity weekly during treatment and~     after one month of completion of treatment.~   "
45554|NCT02460731|"~     This is a phase 1, multi-center, open-label study of the safety, tolerability,~     pharmacodynamics, and preliminary efficacy of young (<30 years of age) healthy male donor~     plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit~     transfusions of young healthy male donor plasma for 6 months.~   "
45555|NCT02460718|"~     It is unclear whether peer coaching is effective in minority populations living with~     diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the~     effect of an innovative peer coaching intervention plus brief education vs. brief education~     alone on diabetes outcomes.~   "
45556|NCT02460705|"~     Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental~     treatment of patients with Crohn's Disease stopped for a safety evaluation.~      This is a prospective, open label pilot study in which patients with symptoms of~     Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.~      The investigators hypothesize that FMT is a safe and effective treatment for patients with~     inflammatory bowel disease. The aims are:~        1. To determine if symptoms of inflammatory bowel disease can be successfully treated by~          Fecal Microbial Transplantation.~        2. To determine if endoscopic appearance of colon or ileum improves following treatment by~          Fecal Microbial Transplantation.~   "
45557|NCT02460692|"~     This study will involve treating low back pain associated with nerve injury with oral~     delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research~     subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or~     placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol~     and vaporized 3.7% Δ9-THC/5.6% CBD .~   "
45558|NCT02460679|"~     Open label study with EPI-589 and ALS subjects~   "
45559|NCT02460666|"~     The purpose of this study is to evaluate the effects after 6 months of supervised weekly~     Tai-Chi-Chi versus Health Education and Wellness classes on reduction of depressive symptoms~     and improvement in resilience, health functioning, quality of life, cognition, sleep, fMRI~     neural correlates of working memory, and brain structure.~   "
45560|NCT02460653|"~     1. To determine the lowest nasal cannula flow rate in which upper airway deadspace is~          reduced. Hypothesis - The lowest flow rate of high flow nasal cannula (HFNC) will~          reduce upper airway (extrathoracic) deadspace and improve respiratory efficiency by~          reducing transcutaneous CO2 and/or lower respiratory rate.~        2. To determine the lowest nasal cannula flow rate in which regional distribution (as~          defined by EIT) of ventilation changes. Hypothesis - Moderate to high flow rates will~          create positive pressure that leads to improved regional distribution of ventilation.~   "
45561|NCT02460640|"~     Single-center study in order to assess whether the tap block can make extremely beneficial~     in terms of reducing the acute and chronic pain as well as for use of opioids and side~     effects related to it in patients undergoing surgery to minimally invasive partial~     nephrectomy.~   "
45562|NCT02460627|"~     More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the~     knee. Walking function and physical activities are affected by this intensive pain although~     local anaesthetic is given in the joint and soft tissue.~      The patients are often discharged on the same day as the arthroscopy takes place depending~     on their ability to walk with or without assistive technology.~      It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice~     pack on a painful knee to reduce pain intensity. The aim of the project is to study whether~     pain intensity and analgesics can be additionally reduced by giving local anaesthetic by~     means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice~     pack on a painful knee.~      The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus~     sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous~     fold removed surgically.~      This study is planned to be a pilot study in order to complete a future large medical~     science study.~   "
45563|NCT02460614|"~     The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal~     clearance with nasopharyngeal aspiration in children admitted with acute viral~     bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute~     viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to~     nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal~     clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups~     children were evaluated three times in the same day in order to verify cardiorespiratory~     parameters, clinical score of respiratory dysfunction and adverse effects.~   "
45564|NCT02460601|"~     The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients~     with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of~     functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.~   "
45565|NCT02460588|"~     Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an~     annual incidence between 5 and 10% and is responsible for the death of one third of IPF~     patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality~     at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF~     but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by~     retrospective series and needs to be confirmed. This confirmation is mandatory to improve~     prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown~     with immunosuppressor in stable IPF.~   "
45566|NCT02460575|"~     Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus~     reuteri DSM 17938 given for five successive days in healthy children. Sixty children will~     receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for~     safety outcomes.~   "
45567|NCT02460562|"~     The purpose of this study is to determine whether a novel material of S-PRG fillers~     containing in a daily-used resin denture base and their capability of fluoride release and~     recharge to elevate the salivary fluoride level and prevent dental caries in Thai~     middle-aged patients between 35-60 years of age who wear the resin denture.~   "
45568|NCT02460549|"~     The purpose of the study is to build and assess the feasibility of a therapeutic education~     program, constructed in collaboration with the urologists of the University Hospital of~     Saint Etienne. The aim of this therapeutic education program is to delay the onset or to~     reduce the amplitude of the development of insulin resistance and side effects of androgen~     deprivation therapy in patients treated with androgen deprivation in the context of an~     evolutive prostate cancer.~   "
45569|NCT02460536|"~     Attention biases in threat processing have been assigned a prominent role in the etiology~     and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes~     computer-based protocols to implicitly modify biased attentional patterns in anxious~     patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious~     10-18 year-olds. Participants will be assessed using clinical interviews and parent- and~     self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control~     groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and~     depression as measured by gold standard questionnaires as well as structured clinical~     interviews with youth and their parents. Attentional threat bias, Attentional control and~     interpretation of ambiguous information will also be measured to explore potential mediators~     of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to~     treatments for anxious children and to provide initial information on mechanisms of ABMT~     efficacy.~   "
45570|NCT02460523|"~     Evaluation of the best line of treatment of borderline CBD stones associated with~     gallbladder stones whether by conservative treatment or endoscopic stone extraction as~     regard complete clearance rate of the CBD stones followed by laparoscopic cholecystectomy.~     The secondary outcomes are overall complications related to each approach, technical~     difficulties and conversion rate during laparoscopic cholecystectomy and cost benefit~     relationship of each line of treatment.~   "
45571|NCT02460510|"~     Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation.~     Information would be collected regarding the onset and duration of symptoms, etiology, and~     severity of disease, other baseline clinical features, demographic characteristics, routine~     biochemical and hematological investigations. Patients would also be screened for the~     assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD~     (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found~     to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the~     study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where~     as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate~     of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of~     144-155 mmol/L .Both the groups would receive other supportive measures such as head end~     elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard~     medical treatment.~   "
45572|NCT02460497|"~     The purpose of this study is to characterize the effect of Minoxidil 2% Solution and~     Botanical Hair Solution Regimen in women with thinning hair and female pattern hair~     loss/androgenic alopecia (Ludwig I and II).~   "
45573|NCT02460484|"~     Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to~     children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to~     determine if hUCB infusion is safe, if late functional outcome is improved, if hUCB~     treatment improves physiologic response in the child's SSEP & EEG, and the effect of hUCB~     infusion in altering anatomic findings on MRI.~   "
45574|NCT02460471|"~     Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity~     Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of~     life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.~   "
45575|NCT02460458|"~     A 5 - year International Registries and Prospective Study on VWD Type 3, aimed to assess~     number, types and risk factors for bleeding and the efficacy and safety of VWF concentrates~     used to treat VWD patients .~   "
45576|NCT02460445|"~     AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting~     on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk~     factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic~     hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to~     usual clinical practice.~      METHODOLOGY~      Open label, controlled, parallel, prospective study of 12 months of duration, with 2~     randomized arms of follow-up:~      i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment~     randomly allocated to perform scheduled phlebotomies from the third month of treatment to~     the end of the study (3 times with a 3-month interval between them).~      ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment~     randomly allocated to follow-up without bloodletting.~      The whole group of patients will undergo a comprehensive anthropometric and hormonal~     assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and~     carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory~     and office blood pressure monitoring, proinflammatory profile, oxidative stress status,~     autonomic function assessment, and iron-related metabolism parameters at baseline, after~     3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention~     Group of patients, and throughout follow-up under treatment with COC in the Control Group of~     patients. If a significant relationship between circulating hepcidin levels and elevated~     ferritin concentrations is observed, a study of the potential influence of~     mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as~     well.~   "
45577|NCT02460432|"~     The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover~     III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary~     obstruction.~   "
45578|NCT02460419|"~     This multicenter, randomised, phase 3 study is to evaluate the survival benefit of~     maintenance capecitabine plus best supportive care versus best supportive care for~     metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative~     chemotherapy.~   "
45579|NCT02460406|"~     This study is aimed to investigate effectiveness of progressive functional strength training~     protocol (functional squat system with virtual reality in leg press, plyometric exercises,~     exercises with Bosu ball & heel-rise exercises) on Body Functions and activity in children~     with unilateral spastic Cerebral Palsy (CP) by applying current guidelines. According to~     literature, there are studies that investigate the effects of functional strength training~     in children with CP. But there is no randomized controlled trial, explore the effects of~     progressive functional strength training protocol on body functions and activity on~     unilateral spastic CP. Hypothesis of this study is that progressive functional strength~     training protocol improves performance-related physical fitness, gross motor function,~     dynamic, balance, muscle tone and muscle strength in unilateral spastic CP.~   "
45580|NCT02460393|"~     This study is a randomized, double-blind and placebo-controlled trial with healthy subjects.~     There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12~     people. A single subcutaneous injection will be administrated starting from the low dose~     group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously).~     Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and~     pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects~     will be evaluated.~   "
45581|NCT02460380|"~     Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is~     characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction,~     hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating~     evidence suggests that transforming growth factor-β (TGF-β) dysregulation may be implicated.~     TGF-β is the prototype member of the TGF-β superfamily of proteins. TGF-βs exert a diverse~     range of biological functions regulating cell proliferation, angiogenesis, fibroblast~     activation and tissue fibrosis. PCOS ovaries show all the hallmarks of TGF-β upregulation,~     including increased collagen deposition in ovarian stroma and theca, supported by increased~     vascularity. Consistent with this, The investigators recently showed that TGF-β1 is~     increased in serum of PCOS women while its circulating receptor soluble endoglin (sENG) is~     decreased, resulting in greater TGF-β1 bioavailability. PCOS patients also have decreased~     vitamin D levels, and vitamin D treatment has been previously shown to improve various~     clinical parameters in PCOS women, including glucose intolerance, hypertension and androgen~     levels. Interestingly, vitamin D has been shown to decrease TGF-β1 levels in several~     diseases where TGF-β1 is elevated, including myelofibrosis. Therefore, the investigators~     hypothesize that vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1~     levels concomitant with improvement in clinical disease parameters. In addition, the~     investigators hypothesize that improvement in clinical disease parameters will correlate~     with changes in TGF-β1 bioavailability. Our aim in the present study is to investigate the~     effects of vitamin D treatment on serum TGF-β1/sENG levels in PCOS women, and assess whether~     changes in TGF-β1/sENG levels following vitamin D treatment correlate with clinical disease~     in these women. For this end, PCOS patients who are vitamin D-deficient will be treated with~     vitamin D and their serum levels of TGF-β1 and its sENG receptor will be measured before and~     after treatment. In addition, clinical disease parameters will be recorded before and 4~     months after treatment, including serum glucose and insulin levels, serum androgen levels,~     and blood pressure.~      The proposed study aims to identify a putative link between vitamin D and TGF-β1 in the~     context of PCOS, and provide a novel molecular explanation for the beneficial clinical~     effects of vitamin D on PCOS patients.~   "
45582|NCT02460367|"~     This is a Phase 1/2 trial using indoximod, an inhibitor of the immune checkpoint pathway~     indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and~     Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a~     practical standpoint, a successful tumor immunotherapy will likely require a combination~     treatment with additional therapeutic interventions that both activate an immune response~     and remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the~     combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of~     cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune~     system to recognize the abnormal components found in lung cancer cells, resulting in an~     immune response intended to destroy or block the growth of the cancer; and the second, the~     IDO inhibitor Indoximod, will overcome tumor-induced immune suppression.~      The goal of this study is to assess the progression-free survival (PFS) and overall survival~     (OS) rates in this patient population. This study will provide a foundation for future~     trials testing indoximod combined with tergenpumatucel-L.~   "
45583|NCT02460354|"~     The purpose of this study is to determine whether metformin can increase urine concentration~     (osmolality) and decrease the amount of urine in patients with congenital nephrogenic~     diabetes insipidus (NDI).~   "
45584|NCT02460341|"~     This project investigates the effects of a single dose of ondansetron on brain function in~     healthy adults. The investigators hypothesize that there will be a dose-dependent reduction~     in activation of the insula and somatosensory brain regions associated with the use of~     ondansetron.~   "
45585|NCT02460328|"~     -  Evaluate about age of resolution in immune defect in 22q11.2 Deletion Syndrome~        -  Incidence of immunodeficiencies in 22q11.2 Deletion Syndrome~   "
45586|NCT02460315|"~     Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD)~     stones. However CBD stones can also be formed in the absence of gallbladder stones. The~     current standard of treatment for calcular obstructive jaundice is endoscopic removal of the~     stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for~     patients with CBDS. Stone extraction is successful in up to 97% of patients The time~     interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may~     vary from days to months. Some retrospective and other prospective studies have investigated~     this issue without sharp clue or definite conclusion This study planned to compare early LC~     (within admission) versus late LC (after 1 month) after ERCP as regard technical~     difficulties and surgical outcomes.~   "
45587|NCT02460302|"~     Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by~     dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic~     vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally,~     local estrogens have been used to treat atrophic vaginitis~      Studies have shown that there are progesterone receptors in vaginal tissues. The use of~     progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been~     studied in other populations including as a fertility medication in pregnant women.~      There is a significant group of women who cannot use, choose not to use, or do not respond~     to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal~     progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a~     randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the~     treatment options for patients with symptoms of vaginal atrophy.~   "
45588|NCT02460289|"~     The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical~     Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic~     alopecia (Norwood III & IV).~   "
45589|NCT02460276|"~     In this trial, patients with mantle cell lymphoma will be included, treatment with~     lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to~     12 cycles, cycle length 28 days. Patients with complete remission, partial response or~     stable disease will enter a maintenance phase with treatment with ibrutinib and rituximab~     until progression of disease.~      The primary objective is to evaluate overall response rate, based on PET and CT.~   "
45590|NCT02460263|"~     The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center~     by trained individuals and In-Home by trained Subjects.~   "
45604|NCT02460081|"~     Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind,~     placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU)~     with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects.~     This study will investigate the hemodynamic effects, clinical efficacy, and safety of 3~     monthly intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.~   "
45591|NCT02460250|"~     According to the French Biomedicine Agency annual report on retrieval activities and~     transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount~     of brain death donors and retrieved liver grafts appears relatively stable, it remains~     clearly insufficient compared to the increasing number of patients on the waiting list for~     liver transplantation (2,462 in 2011). The median time on the waiting list before liver~     transplantation which was established from the cohort of patients registered between 2007~     and 2011 (excluding patients registered for emergency transplantation and for living~     related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009~     to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts,~     donors acceptance criteria were broadened. For example, alternative transplantation lists~     were created with liver grafts coming from so-called marginal donors. However, despite~     these efforts, livers were retrieved on only two out of three brain death donors, i.e. in~     1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not~     enough to meet the increasing needs in liver grafts and a growing number of patients wait~     each year for transplant. Strategic lines of improvement were defined in order to meet the~     2012-2016 transplant perspective which targets 5,700 transplants carried out in 2015 (+5%~     every year, all transplants included, with 5,023 transplants in 2012).~      According to the last consensus conference on liver transplantation of the HAS (French High~     Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar~     steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists~     in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from~     16% to 31% in the general population, and increases up to 46% in heavy drinkers and to~     50-80% in the obese population. Steatosis results mostly from alcohol consumption and from~     metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic~     fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to~     certain medications. NAFLD involves up to 30% of the population in Western countries and its~     prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to~     steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly,~     the improvement of liver grafts selection based on objective quantitative criteria which~     takes into account the degree of liver steatosis appears crucial to increase the number of~     hepatic transplants.~   "
45592|NCT02460237|"~     This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test~     intervention among women from Ohio Appalachia in order to determine the feasibility of HPV~     self-testing as a potential cervical cancer screening strategy. The intervention group will~     receive culturally appropriate materials and the control group will receive standard~     materials with their HPV self-test device.~   "
45593|NCT02460224|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination~     with PDR001 to adult patients with solid tumors. The study consists of a dose escalation~     phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D)~     for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II)~     which will characterize treatment of LAG525 as a single agent and in combination with PDR001~     at the MTD or RP2D.~   "
45594|NCT02460211|"~     Each patient who is admitted for preoperative preparation for elective open heart surgery at~     Intermountain Medical Center will be invited to participate in this study. After a written~     informed consent is obtained, patients meeting inclusion/exclusion criteria will be~     randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the~     treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The~     first dose will be given the evening before surgery. The second and third doses will be~     given either orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be~     obtained at the following time periods: 1) At baseline pre-procedure 12 to 18 hours before~     planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after~     surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after~     surgery); and 6) At the 6-month follow-up visit (post-surgery). Plasma levels of 25(OH)~     vitamin D will be measured on each sample.~   "
45595|NCT02460198|"~     In this study, participants with previously-treated locally-advanced unresectable or~     metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high~     colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®)~     monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A,~     participants are required to have been previously treated with standard therapies, which~     must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has~     been completed. For Cohort B, participants are required to have been previously treated with~     at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or~     fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal~     growth factor regulator (EGFR) monoclonal antibody.~   "
45596|NCT02460185|"~     Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy~     as a method to enhance spontaneous labor.~   "
45597|NCT02460172|"~     Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for~     wound closure following bi lateral knee replacement surgery.~   "
45598|NCT02460159|"~     This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin~     (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants~     with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin~     up to 20 mg. There is no formal hypothesis for the study.~   "
45599|NCT02460146|"~     The main purpose of this trial is to demonstrate the safety, tolerability and~     pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending~     oral doses over 14 days to healthy obese male volunteers.~   "
45600|NCT02460133|"~     This pilot study is crucial to determining whether treating individuals who are at high risk~     for transmission or re-infection will impact HCV reinfection rates. It will establish the~     feasibility of DAA treatment in corrections facilities, as well as delineate the underlying~     immune basis of HCV cure and reinfection.~   "
45601|NCT02460120|"~     The Archimedes System is an image-guided navigation system used to access tissue samples in~     the lungs. This study is being conducted to confirm the performance of the Archimedes System~     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung~     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor~     is conducted.~   "
45602|NCT02460107|"~     The purpose of this study is to determine whether botulinum toxin A is effective in the~     treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.~   "
45603|NCT02460094|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     intravenous infusions of BMS-986168 and to assess the pharmacodynamics of BMS-986168 on~     cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with~     Progressive Supranuclear Palsy.~   "
45605|NCT02460068|"~     This Phase 3, open-label, triple arm study aims to evaluate the overall survival (OS) of~     fotemustine versus the combination of ipilimumab and fotemustine or the combination of~     Ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis.~   "
45606|NCT02460055|"~     The purpose of this study is to conduct a randomized clinical trial to compare the incidence~     of dysphagia in patients receiving general anesthesia with and without an endotracheal tube~     for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased~     following endotracheal intubation for this procedure it could influence the investigators~     practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal~     application of lidocaine at the time of intubation for example.~   "
45607|NCT02460042|"~     The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing~     balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral~     arteries. It is the intention of this trial to treat suitable target lesions with drug~     coated balloon (DCB) only.~   "
45608|NCT02460029|"~     The aim of this study is the visualization of the mesh surface and the confirmation with MRI~     scan at 1 month and 13 months after standardized retromuscular incisional hernia repair with~     the visible CICAT mesh (Dynamesh®).~   "
45609|NCT02460016|"~     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect~     of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).~   "
45610|NCT02460003|"~     This study evaluates the effectiveness of physiotherapy program in the treatment of cluster~     headaches. Half of participants will receive a program of physiotherapy and usual drugs,~     while the other will receive an exercise program and usual drugs.~   "
45611|NCT02459990|"~     Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication~     during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in~     the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of~     Antihypertensive treatment in women.~   "
45612|NCT02459977|"~     Basiliximab has been a routine induction therapeutic agent even for well-matched living~     kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus~     is a different drug from cyclosporine, the investigators study the usefulness of~     tacrolimus-based immunosuppression without basiliximab in well matched living KT.~   "
45613|NCT02459964|"~     The goal of this clinical research study is to compare fentanyl nasal spray with a standard~     drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in~     patients coming to the emergency department.~   "
45614|NCT02459951|"~     Relevant to patients with spastic hemiparesis in the hand and upper limb, this pilot project~     proposes to measure the effects of botulinum toxin injections through observation of~     performance on a functional task known as 'hand as a holder'. This task requires the person~     with hemiplegia to insert an object into the affected hand and hold it independently.~      The project aims to demonstrate reliability and validity of a digital video method that will~     be used to measure 'insertion time'. It also aims to establish initial statistical support~     for improved object insertion time into the hemiplegic clenched fist after Botox A~     injections.~   "
45615|NCT02459938|"~     The purpose of this study is to determine whether glucagon administered by microneedle patch~     is comparable to glucagon administered by injection pen in the treatment of insulin-induced~     hypoglycemia.~   "
45616|NCT02459925|"~     The MOMS Partnership aims to create MOMS Zones in New Haven neighborhoods where the~     hardest to reach families live. These MOMS Zones will have two unique features: (1) a MOMS~     Hub to deliver centralized mental health and family economic success services to the~     hardest to reach families living in New Haven's most impoverished neighborhoods, as measured~     by actual socio-economic status as well as by access to resources; (2) a neighborhood~     workforce of Community Mental Health Ambassadors (CMHAs--mothers who themselves live in New~     Haven). The MOMS Workforce Program and MOMS Mental Health Program will be offered at all~     three Hubs.~   "
45617|NCT02459912|"~     Men with low-risk, clinically localized, unilateral prostate cancer will be treated with~     unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control~     and health related quality of life outcomes after treatment.~   "
45618|NCT02459899|"~     The primary objective of this study is to define the dose leading to desirable efficacy, as~     measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.~   "
45619|NCT02459886|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy~     participants and participants with early Parkinson's disease (PD). Secondary objectives of~     the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose~     administration and to evaluate the immunogenicity of BIIB054 after single-dose~     administration.~   "
45620|NCT02459873|"~     Children with low executive function, working memory and attention skills in childhood not~     only do poorly at school, but also go on to do poorly on social, health, and financial~     indicators in adulthood.~      The rate of executive function disorders in children is vastly underestimated at 17% , even~     when taking into account two of the more widely known disorders of Attention Deficit~     Hyperactivity Disorder (11%) and Fetal Alcohol Spectrum Disorders (6%), but children of~     lower socioeconomic status are especially vulnerable due to reduced resource availability.~      As executive function, working memory and attention skills are central to success in later~     life, if children with low skills can be given targeted training to improve the skills they~     fall short on, there is potential to both improve their short-term academic performance, and~     influence long-term achievement. In fact, poor executive function skills and poor attention~     and working memory is a large predictor of poor performance even in typically developing~     children who are doing poorly academically.~      Hypothesis 1. Those with lower working memory will also have lower problem solving skills~     and lower indices of other executive functioning skills such as reasoning/problem solving.~      Hypothesis 2. Children that start with lower WM and PS will show the highest gains in~     training related performance, and such high gains on WM and PS will lead to better~     performance post-intervention compared to baseline measures of cognitive function.~      Hypothesis 3: Those who make the largest gains in WM and PS with training will show more~     retention of training gains at 6 months compared those who show lower gains.~      Aim 1. Assess working memory (WM) and processing speed (PS) skills in children and their~     inter-relationships with executive functioning skills Aim 2. Examine change in cognitive~     function in WM and PS after intensive training in WM and PS, during and immediately~     post-intervention Aim 3. Examine long-term retention of training effects on WM, PS, and~     executive functions.~      The purpose of this study is to establish an effective and targeted working memory and~     processing speed intervention in children ages 7-10 with low to average executive function~     skills, by utilizing home-based computer games specifically designed to appeal to children.~      Following institution approved consents, 60 low socioeconomic status children from Los~     Angeles will be recruited and enrolled in the study and be asked to play specific fun, but~     targeted cognitive computer games for 10 weeks.~      The results of this pilot study will establish a protocol for feasibility of improving~     executive function skills in children with underdeveloped skills and inform on sufficiency~     of sample sizes, length of interventions, and directly impact computer-based intervention~     research and cost-effective techniques in children's cognitive development within the next~     3-5 years.~   "
45639|NCT02459626|"~     StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that~     will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right~     ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac~     MRI is a valid, non-invasive method to assess diastolic function in patients with Heart~     Failure with preserved ejection fraction.~   "
45621|NCT02459860|"~     The purpose of this study is to determine whether individually-administered Problem Solving~     Treatment is effective in managing depressive symptomatology in 250 primarily~     Spanish-speaking Latino patients ≥55 years of age or older with high medical comorbidity.~     The aim is to test if Programa Esperanza improves: a) problem solving skills and behavior~     activation; b) depression-related outcomes; and b) physical functioning compared to enhanced~     usual care over the course of one year.~   "
45622|NCT02459847|"~     The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and~     mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain~     understanding of patient perceptions, preferences, and experiences with mind-body~     interventions.~   "
45623|NCT02459834|"~     Diabetes remains one of the most important unmet prevention and treatment challenges, and~     the prevalence of diabetes continues to grow. Some functional food ingredients may hold~     promise as potential therapies for diabetes. One such functional food is allulose, which is~     a c-3 epimer of fructose. Allulose is a non-caloric sugar found naturally in small amounts~     in foods such as dried fruits, brown sugar and maple syrup. Previous research has found that~     catalytic doses of fructose and allulose have been shown to decrease the postprandial~     glycemic responses to high glycemic index meals. Fructose, in exchange for other~     carbohydrates, has also been found to decrease HbA1c levels. Whether the effects of fructose~     and allulose are equivalent is of particular interest, as allulose represents a non-caloric~     alternative to fructose. The minimum 'catalytic' dose at which improvements in carbohydrate~     metabolism are observed also remains to be determined for each of the sugars in people with~     and without diabetes. This study is an acute randomized controlled dose-finding equivalence~     trial to assess the effect of fructose and allulose at 2 dose levels (5g and 10g) compared~     with control (0g) on the glucose and insulin responses to a 75g oral glucose tolerance test~     (OGTT) in healthy and type 2 diabetes participants.~   "
45624|NCT02459821|"~     Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in~     young adults,affecting mobility and ambulation in the majority of patients. At least 50% of~     individuals with MS will require an assistive device to ambulate within ten years of~     diagnosis. Impaired mobility is one of the top three factors associated with inability to~     continue working. In addition,impaired mobility and the inability to walk functionally~     translate into significant costs for personal assistance, medical complications, and lost~     wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as~     perform safe and effective transfers,is a fundamental goal in the management of individuals~     with MS. None of the currently available MS disease-modifying medications have been shown to~     stop or reverse gait disability. Repetitive locomotor training is an innovative approach in~     gait disturbances in patients with MS. Only scant data on this issue is available and all~     the studies have been performed by means of treadmill training or robot assisted gait~     training (RAGT) approaches. The recent introduction of a robotic device to gait~     rehabilitation showed a significant improvement in gait ability in patients with~     neurological disease due to the possibility of being trained under a graduated body weight~     support condition and being being guided to reproduce a physiologic gait pattern.~      In 2010 a novel device called GE-O System was developed. It enables patients to repetitively~     practice walking on the floor and also climb up and down stairs. To date, the effectiveness~     of this novel device has not yet been evaluated in patients with MS. The aims of the study~     are as follows: to evaluate the effectiveness of a specific gait training program consisting~     of the GE-O System in patients with MS in improving balance and walking ability,reducing~     fatigue,the frequency of falls,the fear of falling and disability in activities of daily~     living and finally,improving quality of life.~   "
45625|NCT02459808|"~     Constipation is a common condition among patients with Guillain-Barré Syndrome. It is~     believed, that the constipation is caused by autonomic neuropathy. However, the severity of~     the constipation, and its relation to autonomic function have not previously been studied.~   "
45626|NCT02459795|"~     The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an~     FDA approved drug in the treatment of actinic keratosis.~   "
45627|NCT02459782|"~     Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic~     throught the orbit to be successful and has a relatively high failure rate. This study will~     examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the~     depostion of local anaesthetic by using a dual quadrant injection technique. The study will~     assess the feasibility of this technique, how successful it is and whether any obvious~     safety issues arise with its use.~   "
45628|NCT02459769|"~     The purpose of this study is to test preliminary efficacy, as well as acceptability and~     feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer~     survivors and their non-professional caregivers as dyads to either an individual or a dyadic~     Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be~     psychological distress. Analyses will involve pre-post comparisons of outcomes across the~     study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will~     result in greater improvements in psychological distress than an individual intervention.~   "
45629|NCT02459756|"~     Regular consumption of fruits and vegetables may improve human health and reduce the risk of~     chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active~     components and the underlying mechanisms are poorly understood. Berry fruits are abundant in~     anthocyanins and this study aims to test the hypothesis that ingestion of an~     anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health~     of blood vessels, inflammation and platelet function). Further, the study will investigate~     the anthocyanin bioavailability from the blackcurrant beverage.~   "
45640|NCT02459613|"~     Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology~     involving the aggregation of activated platelets with phosphatidylserine (PS) expression on~     the outer layer of the thrombus. They also share common complications, i.e. damages to the~     underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic~     work-up, currently relying on morphologic imaging alone (mainly echography), lacks~     sensitivity and does not allow to differentiate between active (renewal and growth activity)~     and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach~     able to non-invasively provide insight on the biological activity of thrombi and to detect~     embolic events in a single exam.~      Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity.~     Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by~     apoptotic cells or activated platelets. The ability of the imaging agent to bind mural~     thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex~     vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection~     of vegetations and secondary pulmonary emboli with high sensitivity in various animal models~     of infective endocarditis.~      A radiolabeling kit of annexin V complying with GMP requirements has been developed~     (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available.~     AnniE is a single centre, proof of concept, interventional, open, non-randomized study~     aiming at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in~     comparison with reference imaging in patients presenting with either: 1/ infective~     endocarditis or 2/ atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed~     in a first phase (10 first patients enrolled). Data in relation with safety of the imaging~     agent will be reviewed by an independent Data and Safety Monitoring Board (DSMB); in case of~     positive answer, the study will continue with a second phase. The data gathered in all~     patients (n=120) will be used to determine outcome measures.~   "
45630|NCT02459743|"~     In this prospective multicentric study, the University of Pavia together with the Fondazione~     IRCCS Policlinico San Matteo, Pavia and the IRCCS Fondazione Maugeri, Pavia, Italy will~     provide a systematic analysis of gene mutations in hematological malignancies by using NGS~     techniques. Patients with a conclusive diagnosis of haematological malignancies according to~     WHO criteria referred to the Rete Ematologica Lombarda clinical network (REL,~     www.rel-lombardia.net) will be enrolled. The investigators will analyse genomic DNA~     extracted from hematopoietic cells at different time points of patient disease. The study~     contemplates the use of molecular platforms (Next Generation Sequencing, NGS) aimed at the~     identification of recurrent mutations in myeloid and lymphoid neoplasms, respectively.~     Screening of gene mutations by NGS will be prospectively implemented in the context of REL~     clinical network. Patient samples will be analyzed at diagnosis and sequentially during the~     course of the disease at specific timepoints. The researchers will analyze the correlations~     between somatic mutations, specific clinical phenotypes (according to the WHO~     classification) and disease evolution. This will allow to: 1) identify new recurrent genetic~     mutations involved in the molecular pathogenesis of hematological malignancies; 2) define~     the role of mutated genes, distinguishing between genes which induce a clonal proliferation~     of hematopoietic stem cells, and genes which determine the clinical phenotype of the~     disease; 3) identify mutations which are responsible for disease evolution; 4) define the~     diagnostic/prognostic role of the identified mutations, and update the current disease~     classifications and prognostic scores by including molecular parameters. A systematic~     biobanking of biological material will be provided.~   "
45631|NCT02459730|"~     This study evaluated the clinical and microbiological long-term effects of 1.25% CHX~     associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART)~     technique. Randomized controlled trial was conducted on 40 children with carious lesions~     that received ART either with GIC containing CHX or GIC only. Survival rate of restorations~     was checked at 3 days, 3 months and 1 year after their placement when the unstimulated~     saliva samples were collected for microbiological assessment of mutans streptococci (MS)~     counts. Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p <0.05).~   "
45632|NCT02459717|"~     Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom~     affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have~     been investigated and are now available for the management of constipation in PD.~     Preliminary data have suggested that probiotics could be help improving bowel habits but~     high-quality randomized trials are required in this area. Therefore, the investigators~     designed a randomized trial to evaluate whether the use of a fermented milk containing~     multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in~     PD compared to placebo.~   "
45633|NCT02459704|"~     The aim of this study will be evaluate clinically the use of the Semilunar Coronally~     Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel~     Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients~     will receive EMD associated to SCPF, while the other half, will receive SCPF alone.~   "
45634|NCT02459691|"~     The purpose of the study is to develop a culturally adapted intervention (CAI) program to~     improve weight and physical activity in overweight or obese adult Latinos at high risk for~     developing type 2 diabetes and/or cardiovascular disease (CVD) and to rigorously evaluate~     the effectiveness and implementation potential of the CAI program.~   "
45635|NCT02459678|"~     This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to~     initiate, adhere to, and be retained in care under the Ministry of Health's Option B+~     policy. Under a 3-phased research study the investigators will: (1) conduct formative~     research regarding readiness to start lifelong ART in the pregnant population; (2) translate~     the results of formative research into a readiness assessment tool and an enhanced adherence~     package for pregnant women eligible for Option B+ and (3) conduct an individual randomized~     trial of the enhanced adherence package.~   "
45636|NCT02459665|"~     This is a pilot study to prepare for larger clinical trials. Sixty HIV-negative,~     non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV) by Amsel~     criteria and/or Trichomonas vaginalis (TV) on wet mount or by culture will be treated using~     oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal~     candidiasis, other curable sexually transmitted infections (STIs) and urinary tract~     infection (UTI)), they will be randomised to 4 different vaginal microbiome (VMB)~     maintenance interventions (15 per group) within 3 days of completing oral metronidazole~     treatment: 1) Behavioral 'vaginal practices cessation and safer sex' counselling only~     (control); 2) Behavioral counselling plus 500mg metronidazole pills twice per week for two~     months; 3) Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5~     days immediately after oral metronidazole treatment followed by thrice weekly, for two~     months; 4) Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days~     for two months. In all 3 biomedical intervention groups, vaginal product use may be ceased~     temporarily during menstruation. Participants will be asked to adhere to the interventions~     for 2 months, and VMB assessments will take place before (screening and enrolment visits),~     during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).~   "
45637|NCT02459652|"~     Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for~     Borderline Resectable Pancreatic Cancer~      RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive~     surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with~     intensive local effect may lead to substantial local control and prolongation of survival in~     borderline resectable pancreatic cancer.~      PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent~     radiotherapy for borderline resectable pancreatic cancer.~   "
45638|NCT02459639|"~     Using a comprehensive prospective clinical study design, the investigators intend to compare~     changes in health-related markers in patients with chronic widespread pain (CWP), undergoing~     one of two intervention packages of multimodal health care, namely anthroposophical~     integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based~     conventional care with complementary/alternative (CAM) treatments. As markers, the~     investigators will use indicators of drug utilization and sick leave, as well as constructs~     mirroring possible changes in psychological and existential factors and genomic stability~     (such as telomere length and telomerase levels).~   "
45642|NCT02459587|"~     This study is a randomized controlled trial (n = 500) of a new single-session intervention,~     called Crisis Line Facilitation (CLF), compared to an enhanced usual care condition on~     utilization of the Veterans Crisis Line and other mental health services as well as suicide~     attempt(s). All participants will be recruited during an inpatient psychiatric stay for the~     treatment of a recent suicidal crisis and be re-assessed at 3-, 6- and 12-months post~     baseline. If successful, the proposed study will provide key data on the potential efficacy~     of a brief tool to improve the utilization of an existing resource, the Veterans Crisis~     Line, to reduce suicidal behaviors in VHA patients.~   "
45643|NCT02459574|"~     A streamlined AF ablation procedure done without PV mapping as a daycase is more effective~     than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial~     fibrillation.~   "
45644|NCT02459561|"~     The management of obesity is challenging and obesity surgery is by far the most effective~     treatment currently available. Recent medical research indicates that it also improves the~     management of blood glucose levels in people with type 2 diabetes. Obesity surgery carries~     different risks and benefits and it is important to balance these by choosing the right~     procedure for each patient. Therefore new effective strategies to prevent and reduce obesity~     and its complications such as type 2 diabetes mellitus are needed. This study is designed to~     see whether a new device called the EndoBarrier Gastrointestinal Liner helps patients manage~     their blood sugar levels and lose weight. It is a randomised, placebo controlled trial which~     compares the potential of the EndoBarrier device with conventional drug therapy, diet and~     exercise for obesity related type 2 diabetes, and their effectiveness on metabolic state~     (HbA1c reduced by 20% and blood pressure below 135/85), weight loss, and quality of life. It~     will further evaluate whether any other conditions that may be related to obesity could~     become less severe and collect information about complications to determine the safety of~     the device. The study will also perform various measurements and tests to understand the~     underlying mechanism of the device. After an initial screening visit to determine patients~     eligibility, they will be invited for 14 subsequent visits. Patients will be randomised into~     either having the EndoBarrier device or standard medical therapy treatment for 12 months~     followed by another 12 months follow-up period. They will also be routinely seen by~     specialist dietitian who will provide dietetic support throughout the study.~   "
45645|NCT02459548|"~     The objective of the study is to compare the results of a follow-up and treatment coordinate~     and interactive program performed by the General Practitioners (GP) for Obstructive Sleep~     Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by~     sleep specialists from the sleep unit.~      METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis~     of severe OSA that should start treatment with CPAP. Participating center is Hospital~     Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two~     monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care~     consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it~     was indicated the treatment with CPAP.~      Patients will be carried out in both groups the same follow-up visits in two study arms:~     basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP~     compliance treatment in the two study groups, so that use >= 4h/day is defined as good~     adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's~     satisfaction by visual-analogical scales and quality of life tests; 2) to establish the~     clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP~     complications, type, severity and duration; 4) To figure-out the level of take care of the~     CPAP machine, substitutions and complements, assistance and technical incidents; 5)~     Cost-effectiveness analysis.~   "
45646|NCT02459535|"~     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened~     soft drinks may play a role in the development of diabetes.~      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence~     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and~     even modulate incretin release.~      However, it is unclear, if these findings are valid for all kinds of AS, as they are~     chemically different. Furthermore, data on human subjects are sparse and controversial.~      The investigators will therefore conduct 7 consecutive single oral stimulations with glucose~     or AS alone or a combination. Three different AS will be tested.~   "
45647|NCT02459522|"~     This study aimed to evaluate the reference values for the short-term heart rate variable~     (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic~     tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional~     dataset.~   "
45648|NCT02459509|"~     The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better~     than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.~   "
45649|NCT02459496|"~     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.~     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted~     by pharmacological intervention, although lifestyle modification and dietary treatment would~     be favourable.~      The researchers therefore investigate dietary strategies such as low-carb and very-low~     calory diets regarding their potential to improve metabolism and body weight in (mostly)~     long-term T2DM patients.~   "
45650|NCT02459483|"~     The purpose of this study is to assess the effectiveness of a nurse telephone interview in~     the management of cancer patients treated by oral chemotherapy. This is a multicenter~     prospective randomized controlled pragmatic interventional trial conducted in collaboration~     with two oncology care facilities. Eligible population consists of all patients suffering~     from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients~     will be enrolled in the study. The experimental group will receive a standard followed by a~     medical oncologist, hematologist or radiation therapist as part of routine care, and~     telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will~     receive a standard followed by a medical oncologist, hematologist or radiation therapist as~     part of routine care.~      The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most~     common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea,~     vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity~     Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity~     grades).~   "
45653|NCT02459444|"~     The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and~     athletes, your goal is to recondition the respiratory muscles, providing optimization of~     lung capacity, either for high performance sport as to support metabolic wear caused by~     illness. It is generally agreed the positive impact of the application of a TMI Protocol on~     maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning~     from mechanical ventilation (MV), to the optimization of physical performance in cardiac and~     / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the~     muscle; the specificity of training; the reversibility of the gain and muscle atrophy.~   "
45654|NCT02459431|"~     Randomized controlled trial to determine the efficacy of different needles sizes (22G and~     21G) used in endobronchial ultrasound guided transbronchial needle aspiration~   "
45655|NCT02459418|"~     Comparative PK study after single SC application of Afolia and the reference product (US~     Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference~     product for the area under the curve (AUC) of Afolia.~   "
45656|NCT02459405|"~     Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread~     means of assessing the viability of a laparoscopic anastomosis. The investigators described~     recently the feasibility of microvascularisation assessment with near-infra red technology~     (NIR).~      The aim of this study is to look at the implementation of this technique in a wider~     prospective series of patients undergoing colorectal resection.~   "
45657|NCT02459392|"~     In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be~     examined in (approximately 300) adult patients with low back pain pain caused by failed back~     surgery syndrome (FBSS).~   "
45658|NCT02459379|"~     This is a prospective registry evaluating the safety of performing magnetic resonance (MRI)~     scans on patients who have cardiac implanted electronic devices (CIEDs). This includes~     pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device~     approval or new MRI scanner approval, only for a registry of patients who need to have an~     MRI scan who already have an FDA approved CIED that is not currently labeled for use in~     conjunction with an MRI scan. This registry is very similar to the previously approved~     MagnaSafe Registry that is now closed to new enrollment.~   "
45659|NCT02459366|"~     The objective of three-year research is to investigate the relationship between~     thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle~     contractility, proprioception and standing balance in different ages of asymptomatic~     participants and patients with CMLBP.~   "
45660|NCT02459353|"~     Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when~     added to insulin therapy. The primary objective of this study is to assess the effect of~     dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type~     2 diabetic patients with inadequate glycemic control on insulin.~   "
45661|NCT02459340|"~     The main goal of the proposed project is to assess treatment-induced changes of~     electrophysiological and psychophysiological correlates of the capacity to regulate emotion,~     executive functions, and clinical measures in individuals with (complex) posttraumatic~     stress disorder, dissociative disorders, or borderline personality disorder in naturalistic~     inpatient and outpatient settings.~   "
45662|NCT02459327|"~     This study tests a comprehensive approach to the promotion of school readiness in low-income~     families, beginning shortly after the birth of the child, through enhancement of positive~     parenting practices (and when present, reduction of psychosocial stressors) within the~     pediatric primary care platform. The investigators do so by integrating two evidence-based~     interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]);~     and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for~     families with infants/toddlers identified as having additional risks. VIP provides parents~     with a developmental specialist who videotapes the parent and child and coaches the parent~     on effective parenting practices at each pediatric primary care visit. FCU is a home-based,~     family-centered intervention that utilizes an initial ecologically-focused assessment to~     promote motivation for parents to change child-rearing behaviors, with follow-up sessions on~     parenting and factors that compromise parenting quality.~      Two primary care settings serving low-income communities in New York City, NY and~     Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based~     clinics, providing information about translation across venues where one of the two~     interventions has been previously used alone.~      The investigators plan to test the VIP/FCU model in a randomized trial of 400 families~     utilizing parent surveys, observational data on parent-child interactions, and direct~     assessments of children's development, at key points during intervention follow-up. Analyses~     will address questions of program impact for the integrated program across all families and~     by key subgroups.~      The largest single contribution made by this study is to test whether an integrated primary~     and secondary/tertiary prevention strategy implemented in pediatric primary care can produce~     impacts on early school readiness outcomes, including social-emotional, pre-academic, and~     self-regulation. As such, this study has the potential to provide the scientific and~     practice communities with information about an innovative approach to promoting school~     readiness skills among low-income children.~   "
45663|NCT02459314|"~     This was a multicenter, prospective, randomized, double-blinded, controlled-trial study in~     hypercholesterolemic volunteers (serum LDL-C > 130 mg/dL). Eligible subjects were randomized~     to receive either plant sterol and soluble fiber-enriched soymilk or plain soymilk 360~     mL/day (2 packages a day) for 8 weeks. Venous blood samples were collected from the eligible~     subjects during pre-treatment (screening period; day -7), every 2 week after treatment (at~     the end of week 2, 4, 6 and 8) to test for lipid profiles and fasting blood sugar (FBS).~   "
45664|NCT02459301|"~     The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects~     it has on this type of cancer.~   "
45665|NCT02459288|"~     A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary~     Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet~     inhibition and safety observation.~   "
45666|NCT02459275|"~     The main objective of this project is to asses for safety, feasibility and effectiveness of~     an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral~     Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical~     patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,~     acceptable, and effectively increase protein and energy delivery to critically ill surgical~     patients.~   "
45667|NCT02459262|"~     Part A: The primary objective is to evaluate the safety and tolerability of a potential~     vaccine against Group B streptococcus.~      Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year~     following the first dose.~   "
45750|NCT02458170|"~     The purpose of the project is to examine what kind of molecular mechanism which causes~     inflammatory joint diseases. This examination is carried out by a collection and analysis of~     synovial tissues for patients without inflammatory joint diseases compared to the~     experienced equivalent biopsies from patients with inflammatory joint diseases.~   "
45668|NCT02459249|"~     The objective of this study is to evaluate the effect of a healthy-habits intervention~     tailored to the cultural, economical and social context of the target population in~     cardiometabolic parameters, for a population with no access to specialized health services.~     The intervention was designed considering environmental and economic context like~     availability of food and physical activity spaces; cultural factors like social and culinary~     traditions; individual food preferences. It encompass a selected set of behavioral and~     nutritional strategies aiming to achieve control of metabolic disorders involved and to~     reduce the risk for diabetes.~      The investigators' study is a nine-month clinical intervention with randomized allocation,~     and parallel assignment. For the first six months, the participants in the control group~     will receive the treatment from the primary care service by the Health Minister as~     implemented by the local health center, and for the intervention group participants will~     receive a treatment to improve the quality of the diet and promote the practice of physical~     activity. Both groups will be reevaluated at third, sixth and ninth-months follow-up. The~     physician and the nutritionist of the study will be give the recommendations for diet and~     advice on exercise, mainly by suggesting moderate-intensity activity, such as brisk walks~     for at least 150 minutes/week.~   "
45669|NCT02459236|"~     There is a significant unmet medical need for rapidly acting treatment of subjects with~     severe major depressive disorder (MDD) who have not adequately responded to antidepressant~     therapy. Alternative therapies require weeks to achieve full efficacy, may have significant~     side effects, and still fail in a high percentage of subjects. Rapid reduction of severe~     depression by pharmacological therapy is important to reduce the need for hospitalization~     and risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable,~     N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA~     receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it~     provides rapid onset of antidepressant effects and an effect size similar to that seen with~     experimental intravenous NMDA modulators.~   "
45670|NCT02459223|"~     Present study was designed to evaluate the efficacy of the nutritional intervention, in the~     SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical~     ,Hormonal and Enzymatic parameters before and after the nutritional intervention~     treatment.This study was also intended to study possible functional role of gene HRI (heme~     regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia~     in malnourished children similarly present study has also tried to find anthropometric~     marker and different correlations among study parameters.~   "
45671|NCT02459210|"~     The purpose of this study is to test the feasibility of a modification of CET (Cognitive~     Enhancement Therapy) to address symptomatic and functional difficulties associated with~     Clinical High Risk for Psychosis (CHR).~      Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed~     to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to~     improve school, work, and social functioning. CLUES includes the following:~        1. Computerized cognitive remediation (exercises) to improve cognition.~        2. Social-cognitive skills group designed to teach participants to act wisely in social~          situations.~        3. Individual coaching sessions designed to enhance translation of skills learned from~          computer exercises and the group into real life.~      CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was~     designed for treating individuals with schizophrenia. Research on CET for individuals with~     schizophrenia has found that CET appears to have helped participants improve cognition and~     social and work functioning.~      This study will investigate the feasibility of CLUES for young people who are showing signs~     of clinical risk for psychosis.~      Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of~     target engagement (change in cognition and social cognition), to refine assessment and~     recruitment approaches, to further optimize the treatment manual, and to ascertain~     feasibility and tolerability.~      Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) +~     computer games to explore preliminary evidence of efficacy of CLUES vs. the control~     treatment (n=30).~   "
45672|NCT02459197|"~     The purpose of this clinical trial conducted in patients suffering from chronic pain is to~     study the relationship between individual patients' profile and their analgesic response~   "
45673|NCT02459184|"~     Social processes that impact the health of individuals have been labeled the social~     determinants of health (SDOH). These are the conditions in which people are born, grow,~     live, work and age. These circumstances are shaped by the distribution of money, power and~     resources at global, national and local levels. Perhaps the most important SDOH is income~     security, a person's actual, perceived and expected income. Our objective is to carry out a~     pragmatic randomized controlled trial that evaluates the impact of an income-focused health~     promoter.~   "
45674|NCT02459171|"~     This study seeks to determine the incidence and transmission of avian influenza viruses in~     humans exposed to poultry. Enrolled subjects will be selected from five different rural~     areas (villages) in the Nile delta region in Egypt where poultry are commonly raised. From~     those study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up~     visits to measure sero-prevalence and exposure variables, and more importantly, biweekly or~     weekly visits to measure incidence of infection, measure secondary transmission rates,~     monitor symptoms, and assess immunological response.~      Primary Objectives:~        -  To estimate the incidence of avian influenza (AI) in poultry-exposed human populations.~        -  To estimate sero-prevalent of AI in poultry-exposed human populations.~        -  To investigate potential risk factors associated with AI human infections in~          poultry-exposed individuals.~        -  To investigate secondary infection risk for household contacts.~      Secondary Objectives:~        -  To characterize the antigenic and genetic makeup of AI viruses infecting humans.~        -  To monitor the pathogenicity and disease severity of AI viruses causing human~          infections and the associated immune response.~        -  To investigate the serologic response following confirmed influenza virus infection.~   "
45675|NCT02459158|"~     This study is a randomized, open-label phase I study. The primary objective of this study is~     to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically~     ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess~     the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the~     safety and tolerability of ME1100.~   "
45676|NCT02459145|"~     The general consensus in sports medicine demonstrates a graduated return to activity~     protocol for individuals with post-concussion syndrome. This is commonly practiced but there~     is insufficient literature to indicate evidence-based practice. This study will provide~     evidence of the effectiveness of the clinical gradual return to exercise protocols beginning~     after diagnosis of post-concussion syndrome through standardization and measurement of~     outcomes.~   "
45677|NCT02459132|"~     This study evaluates the impact of a supervised 12-week high-intensity aerobic interval~     exercise program (versus a self-directed exercise usual care group) on established and novel~     surrogate markers of cardiovascular health in a population-based sample of testicular cancer~     survivors.~   "
45678|NCT02459119|"~     This study will test how well Regorafenib controls disease progression in urothelial cancer~     (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous~     therapy with chemotherapy.~   "
45679|NCT02459106|"~     The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal~     muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese~     individuals. This information will be important for our understanding of how the body's~     sugar metabolism is regulated and why people who are obese become insulin resistant and are~     more likely to develop type 2 diabetes.~   "
45680|NCT02459093|"~     A comparison of the type of suture used for cesarean skin incision approximation and the~     subsequent rate of wound complications has not been widely studied. Investigators seek to~     compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in~     Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication~     rates (SSI, hematoma, seroma, wound separation).~   "
45681|NCT02459080|"~     The purpose of this study is to measure the effectiveness and safety of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to placebo, a treatment without activity.~   "
45682|NCT02459067|"~     To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of~     ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer~     (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage~     2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.~   "
45683|NCT02459054|"~     The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support,~     and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years)~     and can safely and effectively support transplant-eligible adult patients (aged 19 - 75~     years) at imminent risk of death from biventricular failure without experiencing permanent~     disabling, stroke-related deficits.~      The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial~     Heart (TAH-t) as a bridge to transplant:~        -  The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of~          the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.~        -  The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc~          TAH-t for transplant-eligible patients 19 through 75 years of age.~        -  The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment~          criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment~          criteria, in order to further characterize the use of the device.~   "
45684|NCT02459041|"~     The study protocol is based on a multi-center semi-quantitative approach of EUS elastography~     data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal~     pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on~     time-intensity-curve (TIC) analysis. A number of parameters must be taken into~     consideration, as the ROIs are still manually selected by the user. The aim of the study is~     to establish an EUS based diagnostic algorithm in patients with pancreatic masses and lymph~     nodes, with negative or inconclusive cytopathology after EUS-FNA, based on previously~     published results and cut-offs of elastography and contrast-enhancement. The proposed~     algorithm of sequential use of real-time elastography, followed by contrast-enhanced EUS~     could be a good clinical tool to help select the patients with possible pancreatic~     adenocarcinoma or malignant lymph nodes, in the setting of patients with negative EUS-FNA~     results.~   "
45685|NCT02459028|"~     Background:~      Chronic pain is one of the most burdensome potential consequences of a physical disability,~     such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range~     between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology~     intervention showed a significant reduction in pain intensity, pain interference, pain~     catastrophizing and depression and an enhancement of subjective well-being and control over~     pain in persons with chronic pain secondary to a physical disability.~      Study Objective:~      Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P)~     in a community-based, single-blind, randomized, controlled, parallel group trial on~     subjective well-being and pain in individuals with chronic pain secondary to SCI.~      Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in~     subjective well-being, and perceived control over pain and (2) greater immediate and~     long-lasting decrease in depression, pain intensity, pain interference and catastrophizing,~     relative to an active control treatment.~      Specific aim 1: To increase the understanding of the mechanisms underlying T3P by~     determining potential mediation effects.~      Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain~     intensity, and (2) positive and negative affect mediate the effect of T3P on life~     satisfaction and depression.~      Objective 2: To identify for whom T3P is most effective by exploring potential moderator~     effects.~      Study Design:~      The proposed study is a single-blind, randomized, controlled trial with a parallel group~     design to determine the effects and mechanisms of T3P in a Swiss community sample of persons~     with chronic pain secondary to SCI.~   "
45686|NCT02459015|"~     The purpose of this clinical investigation is to confirm the medium- and long-term safety~     and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an~     autologous nerve graft to bridge nerve defects in the finger.~   "
45687|NCT02459002|"~     The goal of this study is to learn about the quality of life (QOL) in participants with~     advanced lung cancer.~   "
45796|NCT02457559|"~     This study will determine the long-term safety, tolerability, and efficacy of ONO/GS-4059 in~     adults in a prior ONO/GS-4059 study and whose disease had not progressed on the parent~     study. The dosing regimen will be based on the prior dosing regimen from the parent study.~   "
45688|NCT02458989|"~     This study looks at the difference in surgical scar outcomes between two different surgical~     incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already~     scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's~     Hospital, and that meet the eligibility criteria for this study will be invited to~     participate. After signing the informed consent form, participants will be randomized into~     either one of the two incision methods, but will not know which one they receive. There will~     be two follow-up time points: one at 6 and another at 12 months post-operative. At these~     time points the research team will send a letter to the participant asking them to rate the~     appearance of their surgical scar. They will also be asked to take a picture of their scar~     and send it back to the research team, so that the research team can make an assessment of~     their surgical scar. The study concludes when the 12 month follow-up is complete.~   "
45689|NCT02458976|"~     This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior~     to surgical excision can improve the appearance and symptoms of scars. The primary outcome~     measurement for the study is the quality of the scar in areas pre-treated with PDL vs.~     control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic~     surgical excision will have half of the surgical area pre-treated with PDL and the other~     half pre-treated with cryogen spray.~   "
45690|NCT02458963|"~     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus~     gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic~     ovarian syndrome (PCOS).~   "
45691|NCT02458950|"~     This study is aimed to determine clinical characteristics of patients with anorexia nervosa~     and outcome of treatment at Sirirraj Hospital.~   "
45692|NCT02458937|"~     Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in~     children and adolescents with cancer, particularly among those that have had chronic~     exposure to glucocorticoids and among those having undergone allogeneic hematopoietic stem~     cell transplantation. Patients with hematologic disease are also at risk for developing ON.~      Hip Core Decompression (HCD) is a widely used surgical procedure with several studies~     reporting positive results; however, most are subject to criticism because of the limited~     sample size or the absence of appropriate functional outcome measures.~      The objective of this pilot study is to observe and collect information on several~     functional outcome measures and assess if Hip Core Decompression (HCD) potentially improves~     functional outcomes in children, adolescents and young adults with osteonecrosis.~      PRIMARY OBJECTIVE:~        -  To describe functional outcomes of children, adolescents, and young adults with~          osteonecrosis of the femoral head following hip core decompression surgery. Parameters~          assessed will include pain, functional mobility, endurance, quality of life, and gait~          patterns pre-operatively and post-operatively over time.~   "
45693|NCT02458924|"~     Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin~     test accuracy is not well studied in these patients. The study evaluated the niacin skin~     test accuracy in adult hospitalized schizophrenia patients and their first degree relatives,~     bipolar disorder patients, and healthy controls.~   "
45694|NCT02458911|"~     The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting~     balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions~     (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and~     restenosis from prior endovascular procedures in this sector.~   "
45695|NCT02458898|"~     This is a prospective randomized controlled trial investigating the impact of educational~     bidirectional text message reminders on gluten free diet adherence among adolescents and~     young adults with celiac disease age 12-24. Participants will complete a series of online~     questionnaires assessing quality of life, patient activation, celiac symptoms, and self~     reported dietary adherence at the beginning and end of the study. Participants will also~     have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and~     Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws~     can be done locally, and are at no cost to the participant. Patients are randomized to the~     intervention or control group based on enrollment TTG IgA. Intervention group receives 45~     unique text messages over the 3 month study. A gift card is provided for participation in~     the study.~   "
45696|NCT02458885|"~     Aim of investigators is to conduct a registry of acute myocardial infarction including a~     broad network of critical care / coronary care unit throughout Argentina to increase the~     knowledge about treatments, timing of reperfusion therapy and outcomes, both in-hospital and~     during short-term follow up.~   "
45697|NCT02458872|"~     This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a~     safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient~     units.~   "
45698|NCT02458859|"~     Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus~     standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to~     investigate Time to healing, health economic and patient reported outcomes.~   "
45699|NCT02458846|"~     Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood.~     Uncorrected refractive errors (ie farsightedness) can lead to difficulties in school.~     Unfortunately, many children do not receive vision screening until they have already~     developed irreversible vision problems. This has led to the development of a variety of~     screening protocols and devices that attempt to identify patients at risk for vision~     problems early in life. This study aims to compare the leading vision screening~     devices/protocols to a new device, The Pediatric Vision Scanner, and compare their ability~     to detect vision problems against a gold standard eye exam.~   "
45700|NCT02458833|"~     This study aims to test the effectiveness of a community-based, peer-mentored intervention~     to improve home food preparation practices in families with young children.~   "
45701|NCT02458820|"~     Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with~     worse neurologic outcomes and increased mortality. More prolonged seizures (status~     epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures~     may lead to earlier termination of seizures and decreased seizure burden.~      This study will evaluate whether bedside intensive care unit (ICU) provider interpretation~     of a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more~     rapidly than continuous EEG's routinely read by neurologists.~   "
45702|NCT02458807|"~     The World Health Organisation predicts that lung disease will be the World's third largest~     killer in the future. This research project is looking to see whether the concept of a home~     hospital using the latest gadgets and iPad technology, can help patients stay well and out~     of hospital.~      Portsmouth Hospitals Trust is collaborating with a Company based in the United Kingdom (UK)~     who has developed a test to predict when people with lung diseases, such as; asthma, COPD~     and bronchiectasis, who regularly have chest infections, are about to become poorly with~     another infection - a form of early warning system. The investigators hope that the test~     will eventually be able to be used by the patient at home daily, to help self-manage their~     condition. The test measures whether bacteria are present, in sputum, and in what quantity.~     This information can be used by the patient's healthcare team to consider providing~     treatment earlier, thus controlling the infection sooner and reducing the patient's symptoms~     so that patients can stay at home rather than being regularly admitted to hospital.~      Part of this early warning system that has been developed by the UK Company includes the~     daily measurement of a number of indicators of health. These are usually only measured in~     hospital or by a General Practitioner, but new devices have been made that are simple enough~     for everyone to use at home.~      The investigators will include 30 participants, with non-Cystic Fibrosis (CF) chronic~     respiratory conditions who will be asked to take daily measurements of their blood pressure,~     temperature, weight and how well their heart and lungs are working with easy-to-use devices.~     They will also measure their physically activity with an activity tracker and report their~     wellness and whether they have taken medication daily. Participants will also be asked to~     collect a sample of sputum and urine each morning. Taking the samples and measurements~     should only take between 5-15 minutes each day to carry out.~      The sputum and urine will be tested at the hospital and will be recorded and analysed, so~     that the researchers can learn what happens well before a person with these conditions falls~     sick and needs hospitalisation.~   "
45703|NCT02458794|"~     The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of~     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate~     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM~     (single use - prevention of disease transmission). In the following randomized, crossover~     study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak~     pressure, fiberoptic position and ease of gastric tube placement differ between the~     Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.~   "
45704|NCT02458781|"~     This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of~     ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal~     bacterial overgrowth (SIBO).~   "
45705|NCT02458768|"~     The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by~     evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro~     fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.~   "
45706|NCT02458755|"~     Purpose: Intracranial atherosclerosis is a common condition in Korean population consisting~     over 25% of ischemic stroke etiology. American Stroke Association and Korean Stroke Society~     recommend antiplatelet and statin for the treatment of intracranial atherosclerosis. Besides~     lowering blood cholesterol levels statin also stabilize atherosclerotic plaque and~     eventually lower the risk of ischemic stroke. However, little evidence resides on the effect~     of statin treatment on intracranial atherosclerosis. Recent advance in high-tesla magnetic~     resonance imaging enables direct imaging of intracranial atherosclerotic plaque and further~     assessment of treatment efficacy of statin in stabilization of intracranial atherosclerotic~     plaque became possible.~   "
45707|NCT02458742|"~     Pain after transurethral resection of prostate is considered mild to moderate severity from~     detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have~     been studied including spinal opioids, spinal anesthesia with local anesthetic and~     dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with~     distilled water irrigation while undergoing a procedure. Most of patients having this~     procedure are in elderly period, thus many anesthetists avoided spinal morphine which may~     cause respiratory depressant effect postoperatively. Although previous studies showed~     effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid~     side effects.~      The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal~     morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to~     spinal anesthesia with sole local anesthetic.~   "
45708|NCT02458729|"~     The aim of this study was to conduct a prospective, randomized, double-blind study and~     assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee~     arthroplasty patients when tranexamic acid is used for bleeding prophylaxis.~   "
45709|NCT02458716|"~     This phase I trial studies the side effects of cytoreductive prostatectomy in treating~     patients with newly diagnosed prostate cancer that has spread from the primary site to other~     places in the body. Cytoreductive prostatectomy is a type of surgery that removes the~     prostate and as much of the tumor as possible. When combined with hormone therapy, robotic~     assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy~     (RRP) may prolong survival in patients with prostate cancer that has spread.~   "
45710|NCT02458703|"~     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the~     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This~     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary~     exercise tests performed on a stationary bicycle, and whether this is affected by the~     presence of concurrent airflow obstruction, such as due to asthma.~   "
45711|NCT02458690|"~     The objective of this randomized controlled trial is to evaluate whether the investigators~     modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of~     cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary~     care patients who are depressed but do not have a history of CVD. Half of the participants~     will receive standard depression treatment in primary care (usual care), and the other half~     will receive one year of eIMPACT, a collaborative stepped care program including~     antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate~     change in CVD risk, the investigators will measure artery function using ultrasound before~     and after the 1-year treatment period. It is hypothesized that patients who receive the~     eIMPACT intervention will have greater improvements in artery function than patients who~     receive usual care.~   "
45712|NCT02458677|"~     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX003 in approximately 40 healthy subjects.~   "
45713|NCT02458664|"~     We collect prospectively and retrospectively, patients' demographic, pathological, surgical,~     therapeutic and prognosis informations in a database. After patient's consent to collect~     tumoural samples of their colorectal cancer after resection.~      We will then be able to evaluate the impact of HSP110, a chaperon protein, on their~     prognosis. Other proteins (to be determined) will also be study, after.~   "
45714|NCT02458651|"~     The purpose of this observational study is to describe patient and disease characteristics~     as well as treatment patterns in Chinese patients with unresectable stage IIIB or IV~     non-small cell lung cancer (NSCLC). In addition, this study characterizes the clinical~     outcomes for various populations of patients defined by clinical and tumor characteristics,~     treatment patterns, and hospital category defined by city tier and geographic region.~   "
45715|NCT02458638|"~     The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at~     18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as~     the percentage of participants with complete response (CR), partial response (PR), or stable~     disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in~     Solid Tumors version 1.1 (RECIST v1.1), or according to disease-specific criteria for~     prostate cancer and malignant pleural mesothelioma.~   "
45716|NCT02458625|"~     This study is aimed to compare the efficacy of two mode of iron administration to treat post~     partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron~     sucrose and 6 weeks of treatment with oral iron supplement.~   "
45717|NCT02458612|"~     The purpose of this study is to investigate the effects of mirror therapy combined with~     upper extremity strengthening training on upper extremity function in children with~     unilateral spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the~     literature, there was no randomized controlled trial. According to literature, there are few~     studies that investigate the effects of mirror therapy in children with CP. But there is no~     randomized controlled trial, explore the effects of mirror therapy combined with upper~     extremity strength training on upper extremity functions in unilateral spastic CP.~     Hypothesis of this study is that mirror therapy combined with strength training improves~     upper extremity function and muscle strength in unilateral spastic CP.~   "
45718|NCT02458599|"~     This study is designed to investigate whether protein supplementation can improve recovery~     of muscle function following a strenuous combination of both endurance and resistance~     exercise. It will specifically investigate the effect of protein supplementation on the~     recovery of strength, power and endurance exercise performance, along with measures of~     damage and inflammation of the muscle.~   "
45719|NCT02458586|"~     Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids~     (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid~     content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver~     disease (NAFLD).~      The investigators therefore conduct an interventional trial in subjects with normal glucose~     metabolism, but increased HCL, fulfilling criteria for NAFLD.~      The study will compare two dietary interventions in parallel design, one containing mainly~     PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is~     accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR~     spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin~     sensitivity).~   "
45720|NCT02458573|"~     The investigators hypothesized that sympatholytic effect of epidural analgesia would~     attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by~     pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of~     epidural analgesia and intravenous analgesia on postoperative bowel movement in patients~     undergoing laparoscopic gastrectomy.~   "
45721|NCT02458560|"~     The purpose of this study is to assess the safety and device success of the Edwards CENTERA~     Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic~     stenosis.~   "
45722|NCT02458547|"~     Despite many previous studies, whether anesthetic technique will significantly affect~     overall patient outcome, morbidity and mortality in elderly hip fracture patients is~     controversial. Due to old age, poor patient condition and emergent clinical settings,~     patients undergoing surgical procedures for hip fracture management are often subject to~     poor postoperative outcome and high mortality rates. While many studies have reported that~     regional anesthesia leads to improved postoperative outcome after hip fracture surgery,~     others have concluded otherwise. Moreover, because the majority of these previous studies~     are retrospective cohorts or systemic reviews, there is a need for randomized clinical~     trials to provide high quality evidence. This study aims to compare patient outcome between~     three different anesthetic techniques in elderly patients undergoing surgery for hip~     fracture management by evaluating proinflammatory cytokines, chemistry lab testing and~     clinical outcome between general anesthesia with either desflurane or propofol-based TIVA~     and spinal anesthesia with bupivacaine.~   "
45723|NCT02458534|"~     The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is~     superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for~     novice users in manikin.~   "
45724|NCT02458521|"~     The overall objective of this project is to determine the efficacy and tolerability of TMS~     for mild Traumatic Brain Injury (mTBI) with PTSD symptoms and correlate treatment response~     with anatomical and biological factors unique to each service member (SM). Exploratory work~     will be done to look at the neuronal and biological changes that may occur over the course~     of TMS treatment.~   "
45725|NCT02458508|"~     Glioblastoma (GBM) accounts for approximately 50% of all glioma and among these tumors, are~     the most malignant. The cells of origin of glioma are still undefined, but the most putative~     target cells include astrocytes, neural stem cells, and oligodendrocyte precursor cells. The~     current standard of care for patients with newly diagnosed GBM includes temozolomide and~     radiotherapy . Melanocortins are peptides with well-recognized anti-inflammatory and~     neuroprotective activity. Of the five known melanocortin receptors (MCRs), only subtype 4 is~     present in astrocytes and it is expressed predominantly in the brain. No data are currently~     available on MC4R gene polymorphisms and gliomas or their relationship with radiotherapy or~     chemotherapy.~      Aim. Given the association of MC4R with antiinflammatory activity, neuroprotection,~     induction of neural stem/progenitor cell proliferation in brain hypoxia, and prevention of~     astrocyte apoptosis, the aim of this study is to retrospectively evaluate the possible~     prognostic/predictive role of the MC4R SNPs on GBM therapy.~   "
45797|NCT02457546|"~     The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant~     (Human) for use as an adjunct to sutured dural repair in cranial surgery.~   "
45798|NCT02457533|"~     To investigate the effects of patient counseling by telephone on Quality of Life and the use~     of Health care system.~   "
45726|NCT02458495|"~     A significant percentage of persons with diabetes fail to properly take their prescribed~     oral hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes~     patients is associated with poor health outcomes including suboptimal glycemic control,~     diabetes-related complications, elevated health costs and increased risk of hospitalization~     and mortality. Given the substantial impact of non-compliance on the health of patients,~     prior studies have sought to draw links between medication adherence and patient factors.~      Research shows that web-based interventions that support patients' medication-related~     knowledge, motivation and skills effectively improve compliance.~      The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered~     medication adherence promotion intervention on medication adherence and glycemic control~     among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase~     self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health~     outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge,~     motivation and skills.~      This research will greatly enhance the investigators' understanding of medicine compliance~     and the factors that effectively improve adherence among high-risk patients with diabetes.~     Knowledge gained from this work may inform future internet-based patient portals that~     support disease management and medication adherence more broadly.~   "
45727|NCT02458482|"~     The objective of this randomized control trial is to investigate the efficacy of an adjunct~     positive airway pressure (PAP) nebulizer device known as AccuPAP in the treatment of~     moderate-severity acute asthma exacerbations in children ages 6 - 17 years in comparison~     with an institutional standard continuous dual-therapy nebulizer treatment.~      The investigators main goal, more specifically, is to determine if the additional positive~     airway pressure provided by the AccuPAP device when used in treating children with~     moderate-severity asthma exacerbations provides a more optimal delivery of bronchodilator~     therapy when compared to institutional standard protocol nebulizer delivery mask which does~     not employ the use of positive airway pressure in medication delivery. The investigators~     have determined that the change in a study-validated Acute Asthma Intensity Research Score~     (AAIRS) which will be considered statistically significant for a patient is 2 points or~     greater after the first treatment has been completed.~   "
45728|NCT02458469|"~     The purpose of this study is to look at the effect of exciting using drugs to target a~     specific pathway in the body, that relies on a natural chemical the body produces called~     'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the~     study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone~     (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of~     time followed by two weeks without drugs (washout period). The drugs will not be taken all~     at the same time, but each will be taken separately for two weeks followed by a night study~     to look at the effect the medication/placebo pill has on the way the body responds during~     sleep.~   "
45729|NCT02458456|"~     The aim of this project is to conduct a randomised controlled trial to assess the effect of~     performing isometric exercise using a handgrip dynamometer on blood pressure.~   "
45730|NCT02458443|"~     Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic~     exercise for lowering blood pressure. The investigators intend to conduct the largest,~     longest, prospective, double-blind randomized controlled trial using isometric resistance~     training to reduce blood pressure to reduce hypertension.~   "
45731|NCT02458430|"~     Balance and gait problems cause severe impairments for people with Parkinson's disease In~     some Parkinson's disease patients the investigators see a loss of acetylcholine in the~     brain. In previous studies the investigators have shown that this loss of acetylcholine is~     related to impaired balance and gait function in Parkinson's disease. In this study the~     investigators will take a closer look at this finding.~   "
45732|NCT02458417|"~     The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2~     laser abrasion with superficial full surface ablation, fractional laser treatment and~     conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the~     patient reported outcome and to assess the cellular composition of the graft.~   "
45733|NCT02458404|"~     This study will help determine the effect of varied estradiol levels on the uterine lining~     in healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.~   "
45734|NCT02458391|"~     The purpose of this study is to investigate which number of lymphedema therapy~     treatments/week best reduces upper extremity swelling, increased arm function, and reduces~     the most lymphedema symptoms.~   "
45735|NCT02458365|"~     Male-to-female intimate partner violence accounts for 26% of violence-related injuries in~     women presenting in hospital emergency departments and 33% of all female homicides.~     Adolescence provides an excellent window of opportunity for the prevention of intimate~     partner violence. Patterns of relating in intimate relationships are still relatively~     undifferentiated and open to influence. However, the evidence supporting traditional,~     school-based programs for the prevention of teen dating violence is mixed. A major problem~     with existing programs is that they are one size fits all, making it difficult to meet the~     diverse needs of students—boys and girls, individuals who are dating and those who are not,~     individuals who have experienced dating violence as a victim, perpetrator, or both, and~     those who have not. Perhaps most importantly, these interventions neglect individual~     differences in readiness to use healthy, non-violent ways of relating to stay violence-free.~     In Phase I the objective was to use expert system technology to integrate best practices for~     teen dating violence prevention with the Transtheoretical Model of Behavior Change (TTM),~     the stage model, to develop an interactive, multimedia computer-administered change~     program that delivers individualized intervention sessions and exercises tailored to stage~     of change and other individual characteristics. In Phase II, the objective was to complete~     development of the intervention package and assess its efficacy in a randomized clinical~     trial involving 3,901 teens from 20 Rhode Island high schools randomly assigned to~     intervention or comparison. Among youth exposed to risk for dating violence, efficacy was~     assessed by comparing the intervention and comparison groups on dating violence perpetration~     and victimization at follow-up. Among youth not exposed to risk for dating violence,~     efficacy was assessed by comparing intervention and comparison on peer violence perpetration~     and victimization.~   "
45736|NCT02458352|"~     The aim of the study is to compare the CACS obtained from standard dose CT to the CACS~     obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC~     of myocardial perfusion SPECT will be assessed.~   "
45737|NCT02458339|"~     The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of~     direct administration of methotrexate into the fourth ventricle of the brain in patients~     with recurrent malignant brain tumors including medulloblastoma, primitive neuroectodermal~     tumors (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma.~      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their~     growth and spread throughout the body. This may cause the cancer cells to die.~   "
45738|NCT02458326|"~     Fibromyalgia and migraine are diseases with high prevalence in women between the age group~     of 30-60 years, which seem to share the same pathophysiological mechanism; both originate~     from neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous~     system, and are therefore closely related. In addition to the strong relationship with~     migraine, fibromyalgia can also be associated with sleep disorders, chronic fatigue and~     psychological disorders. The combination of these factors decreases the quality of life and~     contributes to increased sedentary this population. It is known that physical exercise~     promotes positive changes in pain pathophysiological pathway to increase the release of~     endorphins neuroendógenas, improving the symptoms of fibromyalgia.~      The objective of this study is to analyze whether the application of an aerobic exercise~     program may result in the reduction of the frequency, duration and intensity of migraine~     attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized~     double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and~     migraine. Initially, all answer questionnaires assessing quality of life, impact of~     headache, level of depression and anxiety, sleep quality, physical activity level, and; will~     be held ergospirometry for research in exercise tolerance. The experimental group will~     implement the protocol consists of heating, aerobic exercise according to the heart rate~     established for training by spirometry and slowdown; and the control group will hold the~     heat on low speed and heart rate will next baseline. Both groups will be followed for 12~     weeks, with a frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4~     weeks. At the end of the protocol, the groups will have their results were compared and~     statistically analyzed.~   "
45739|NCT02458313|"~     Obesity is a serious and growing health problem in the United States. Obesity is associated~     with health problems such as type-2 diabetes and cardiovascular disease, leading to~     decreased quality of life and increased mortality. Given the health and quality-of-life~     effects of obesity, developing effective treatments clearly is an important goal.~      This study plans to learn more about the effects of an investigational new drug (DMXB-A~     (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has~     similar effects to nicotine. Since nicotine has been found to affect appetite, the~     investigators are interested in studying effects of the study drug, which has some~     similarities to nicotine, on how your brain responds to such things as pictures of food. The~     study drug has not been approved by the Food and Drug Administration (FDA), and is~     considered experimental.~   "
45740|NCT02458300|"~     The objective of this study is to evaluate the clinical response of children diagnosed with~     acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment~     with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to~     2 years.~   "
45741|NCT02458287|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of~     bococizumab and an autoinjector (pre-filled pen).~   "
45742|NCT02458274|"~     The main long-term complication of lung transplantation is chronic lung allograft~     dysfunction (CLAD). Bronchiolitis obliterans syndrome (BOS) is the most frequent~     presentation of CLAD. BOS leads to a progressive loss of lung allograft function, with~     recurrence of dyspnea and airflow limitation. In some advanced cases, patients need a lung~     re transplantation. The mechanisms of BOS are not completely elucidated, and there are no~     early markers or specific treatment available for this condition.~      Microparticles (MPs) are submicron plasma membrane fragments released into the vascular~     compartment or the pericellular space in response to cell activation, injury or apoptosis.~     Broncho alveolar and circulating MPs may reflect cellular insults of the lung allografts.~     Therefore, MPs could be viewed either as biomarkers or as effectors of the chronic~     inflammatory or procoagulant processes leading to bronchiolitis obliterans syndrome.~      The investigators plan to include 60 patients before lung transplantation at our centre in~     Strasbourg (France). Follow-up will be requested at the base of usual care (spirometry,~     blood sampling, bronchoscopy with broncho-alveolar lavage [BAL]). The investigators will~     measure at one month, one, two and three year post transplantation, the total concentration~     of MPs in plasma and BAL and characterize their phenotype.~      The investigators objective is to demonstrate correlation between total MPs concentration in~     broncho-alveolar lavage fluid (BALF) and the occurrence of bronchiolitis obliterans syndrome~     at three years post lung transplantation.~   "
45743|NCT02458261|"~     This prospective, multi-center study aims to determine the pharmacokinetics and~     pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy~     (CRRT).~   "
45744|NCT02458248|"~     Chronic kidney disease, which affects an estimated 300,000 people in Ireland and over 50~     million people in the developed world, is responsible for a considerable burden of premature~     mortality and morbidity. All patients with chronic kidney disease are recommended low salt~     diets, i.e. less than a teaspoon of salt per day (which is <5-6g of salt, which contains~     <2-2.3g of sodium). The average intake in the general population is double the recommended~     intake, between 1-2 teaspoons per day, which is considered 'moderate' intake. In patients~     with hypertension, reducing from moderate (average) to low intake is associated with a small~     reduction in blood pressure. However, achieving this low target salt intake is difficult,~     and can have a negative knock-on effect on other healthy dietary factors and kidney~     hormones. In addition, there is no convincing research to show that patients with chronic~     kidney disease and normal blood pressure benefit from low salt intake. In fact, the small~     amount of research that does exist shows that the change in kidney function is the same in~     people who consume low salt diets (<1 teaspoon) and moderate (1-2 teaspoons=average intake)~     salt diets. Moreover, there are some small studies that report that low-salt diets may~     increase the risk of death due to heart disease. Given that all patients with chronic kidney~     impairment are recommended a low-salt diet, it is important that we confirm that this~     recommendation truly benefits patients. In this randomized controlled trial, we hope to~     determine whether recommending a low salt intake, compared to average/moderate intake, is~     associated with a slower rate of decline in kidney function in patients with chronic kidney~     impairment. The results of this study will provide information to guide future research that~     will have critical implications for management of patients with chronic kidney disease.~   "
45745|NCT02458235|"~     The goal of this study is to determine whether post-transplant consolidation with~     azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach~     for the prevention of relapse in pediatric and young adult patients with hematologic~     malignancies who have undergone hematopoietic stem cell transplantation (HSCT).~   "
45746|NCT02458222|"~     Aphasia is a language impairment experienced by about one third of stroke patients. This~     often devastating condition is treated by speech and language therapists (SLTs). There is~     evidence that language games delivered at the right intensity are an efficacious means of~     improving communication for people with post stroke aphasia. However, it is unclear which~     mechanism of language facilitation used in a game works best. This study will provide~     evidence for the active ingredient of a game, together with measures of efficacy,~     feasibility and enjoyment compared to standard aphasia therapy.~   "
45747|NCT02458209|"~     This is an open label, single dose, randomized, parallel group study in healthy adult~     subjects to assess the comparability of bococizumab administered in a prefilled syringe vs.~     prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs.~     Boehringer Ingelheim Pharma.~   "
45751|NCT02458157|"~     The objective of this pilot trial is to assess the feasibility of forced fluid removal in~     patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid~     overload. The intervention will use furosemide infusion and/or continuous renal replacement~     therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention~     will be compared to standard of care as reflected in the kidney disease improving global~     outcome (KDIGO) guidelines.~   "
45752|NCT02458144|"~     Aim of the present investigation is to analyse the amount of muscle trauma in relation to~     the surgical approach and to the individual postoperative functional recovery. The~     investigation will compare the MIS (minimally invasive surgery) anterior approach with the~     MIS anterolateral approach to the hip.~   "
45753|NCT02458131|"~     The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a~     disproportionate increase among minority youth. The research proposed in this Career~     Development Award will use community-based participatory research methodology as well as~     novel strategies (peer education and mobile health technologies) to design, implement and~     evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban~     community with high disease burden.~   "
45754|NCT02458118|"~     The purpose of this study is to assess pancreatic perfusion in patients with chronic~     pancreatitis at rest and after secretin stimulation and compare this to published data on~     pancreatic perfusion in normal subjects.~   "
45755|NCT02458105|"~     The overarching aim of the research project is to investigate whether Acceptance &~     Commitment Therapy (ACT) is an efficacious psychotherapeutic method of treatment for~     inpatients suffering from acute psychosis.~      The method will be applied in two ways. Firstly, as an individual treatment for patients.~     Secondly, as an integrated part of the daily work on an inpatient ward, administered by~     nurses and assistant nurses trained in the method.~   "
45756|NCT02458092|"~     The purpose of this study is to determine whether an investigational malaria vaccine is safe~     and induces an immune response against malaria when tested in adults living in the United~     States.~   "
45757|NCT02458079|"~     Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a~     dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current~     studies and liver transplantation is with great risk of recidivism in this difficult to~     treat cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis~     patients and modulation of gut microbiota by way of healthy donor fecal transplantation~     could prove to be a novel way to treating these patients who are ineligible for standard~     therapy. This study utilizes correction of dysbiosis in severe alcoholic hepatitis and~     surveys outcomes with the same with respect to survival and liver disease severity scores.~   "
45758|NCT02458066|"~     Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout~     Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC~     62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was~     measured before and after the application of insecticide.~   "
45759|NCT02458053|"~     The purpose of this study is to determine the effect of a spousal support enhanced weight~     loss program on weight loss among African American men.~   "
45760|NCT02458040|"~     This study is a meta-epidemiological study which aim is to quantify the clinical benefit of~     the biomarker-based strategy compared to conventional strategy across all drugs with such a~     strategy.~   "
45761|NCT02458027|"~     The objectives of this trial are to investigate whether the effects of hemp protein on~     glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin~     and appetite for one hour following consumption, 2) blood glucose, insulin and appetite~     following a fixed energy meal to determine the second meal effect of hemp protein versus~     soybean protein and a non-protein control.~   "
45762|NCT02458014|"~     The goal of this clinical research study is to learn if Blinacyto (blinatumomab) can help to~     control ALL with positive MRD. The safety of this drug will also be studied.~   "
45763|NCT02458001|"~     Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer~     and its treatment. Most do not receive appropriate advice or help to recover sexual~     function, and the impact on their sexuality may be profound. Despite this several potential~     therapies can be effective in helping recovery. A major challenge is informing and involving~     the patients in an appropriate and sensitive manner, and a further issue is the delivery of~     such therapies in busy and medically driven gynaecologic oncology clinics. It will use and~     adapt existing evidence based therapies for improving sexual function after cancer treatment~     and develop a model for delivering these in the NHS (United Kingdom National Health Service)~     setting. The model of 'stepped care' is adapted from that used nationally and successfully~     in the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for~     'stepping up and down', i.e. calibrating the type of help a woman receives according to need~     and her response to treatment already given.This study will develop and evaluate a 'stepped'~     system of interventions using elements of best available evidence, adapting existing~     interventions to help women recover their sexual feelings and activity, starting with simple~     methods, moving on to new talking treatments for more complex cases. The investigators~     address all gynaecologic cancers on the principle that sexual difficulty is the problem the~     investigators are treating, not the cancer of origin. Ongoing clinical assessment will be~     vital for the success of the stepped care model. The investigators will deliver training and~     supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An~     important part of this study will be characterising the range of women and their willingness~     to participate in psychosexual help. One-to-one follow up interviews will inform the level~     of input required for any subsequent Randomised Control Trial (RCT). The investigators will~     use internationally recognised rating scales for rating sexual function, assess how illness~     and treatment affect mood and self esteem. The investigators will also measure the overall~     cost-effectiveness to the public sector of providing this treatment, compared to costs of~     subsequent use of health and social services. This pilot study will assess the feasibility~     of conducting a full scale investigation of a stepped therapy and indicate the potential~     benefits to the patients, their partners, and to the NHS generally.~   "
45764|NCT02457988|"~     A prospective series comparing care incorporating home monitoring and liver care~     coordination to conventional care for patients with cirrhosis.~   "
45765|NCT02457962|"~     To collect and analyze specimens that will correlate with clinical outcomes such as acute~     and late toxicities, quality of life, local control, and survival of patients treated with~     photon/proton therapy.~   "
45766|NCT02457949|"~     This study evaluates whether altering the timing and frequency of social assistance~     disbursement reduces drug related-harms that increase on the days surrounding monthly~     synchronized government social assistance cheque issue.~   "
45799|NCT02457520|"~     This is an uncontrolled, open-label study being conducted in approximately 200 healthy~     males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant~     nodular acne.~      ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by~     1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or~     abstinence are included.~   "
45767|NCT02457936|"~     Depression one of the leading causes of disability worldwide. Individuals suffering from~     depression typically exhibit impairments in various mental abilities, such as the ability to~     effectively direct and control attention and the ability to switch between thinking about~     different things and concepts (commonly referred to as cognitive flexibility).~      Mindfulness meditation training is a technique which involves focusing one's awareness on~     the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and~     bodily sensations. It has been well documented to improve depressive symptoms and prevent~     recurrence of depressive episodes, yet little is known about how mindfulness does so and~     what are the underlying mental mechanisms involved. Here the investigators propose to~     examine the efficacy of an 8-week mindfulness training program in improving the ability to~     direct and control attention, as well as in cognitive flexibility.~      Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training~     program. Participants' depressive symptoms as well as their performance on measures of~     attention and cognitive flexibility will be examined. Participants will be assigned to~     mindfulness training or a wait-list control group. Half of the participants will be examined~     before and after the mindfulness training program and the other half will be tested 8-weeks~     apart and then begin their training.~   "
45768|NCT02457923|"~     Using a community-based, cluster randomized controlled trial design (cRCT) the investigators~     will examine the impact of an integrated m-health package -(M- SAKHI) for mothers on~     appropriate infant feeding practices, starting in the first / second trimester of pregnancy~     to 24 months after delivery, to improve child feeding practices and child growth, and reduce~     the prevalence of undernutrition in their children. This will result in two treatment~     groups. The clusters for the trial will be villages under the administrative area of ASHAs~     (Accreditated Social Health Activists). Villages with a population of 1000- 2000 (ranging~     from 751 to 2000) with 1 ASHA will be randomized to receive intervention (intervention~     villages) or continue existing delivery of care (control villages). The data will be~     collected using a longitudinal design because the investigators want to study the impact of~     intervention on the mothers starting at pregnancy until her infant is 24 month old.~   "
45769|NCT02457910|"~     This partially randomized phase Ib/II trial studies the side effects and best dose of~     taselisib when given together with enzalutamide and to see how well they work in treating~     patients with androgen receptor positive triple-negative breast cancer that has spread to~     other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is~     cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the~     growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with~     enzalutamide may be a better treatment for patients with breast cancer.~   "
45770|NCT02457897|"~     Background:~      - Insulin receptor mutation causes high blood sugars and sometimes diabetes complications.~     Researchers want to see if thyroid hormone helps.~      Objectives:~      - To see if thyroid hormone treatment changes how the body handles sugar in people with~     insulin receptor mutation and improves blood sugar in people with diabetes.~      Eligibility:~      - People ages 12 65 with an insulin receptor mutation.~      Design:~        -  Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15~          days they will take a thyroid hormone pill 3 times a day. Participants will have:~        -  Blood tests.~        -  Heart rate and skin temperature monitored.~        -  All their food provided.~        -  Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit~          still.~        -  Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with~          a non-radioactive tracer. Participants will also drink water with a tracer. The other~          tube will collect blood.~        -  A sweet drink. Participants may have finger stick blood sugar tests.~        -  Glucose-monitoring device inserted into body fat for two 24-hour periods.~        -  Adults may have samples of fat and muscle taken.~        -  Heart ultrasound.~        -  PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A~          small amount of radioactive substance will be injected.~        -  DEXA scan of body fat and bone density.~        -  Participants with poorly controlled diabetes will then take thyroid hormone at home for~          6 months. They will have blood drawn and sent to the study team monthly.~        -  After about 3 months, they will have an overnight visit. After 6 months, they will have~          a 4-day visit.~   "
45771|NCT02457884|"~     Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has~     swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity~     finally. However, some patients still have difficulties in reading even after proper~     treatment.~      In this project, the investigators aimed to explore the effectiveness of different training~     paradigms in improving reading performance in patients with DMO.~   "
45772|NCT02457871|"~     The specific study aims are to: 1) examine differences between an Ecological Nursing Case~     Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and~     health status to establish effect sizes needed for a future large randomized controlled~     trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3)~     examine moderating effects of gender and perceived stress on the intervention effect. This~     is a two-group randomized experimental study with repeated measurements. Clients in the~     treatment group (n=25) will receive the individualized ENCM and those in the comparison~     group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6~     months to capture the immediate, short and longer term effects of the intervention.~   "
45773|NCT02457858|"~     In this study, the investigators hypothesize that the addition of antioxidant BMX-010 to~     perfusion solution, digestion solution and culture medium during islet isolation process,~     can lead to greater preservation of islet mass and metabolic function, such as improved~     islet yield, viability, and functional potency.~      This pilot study will involve up to 10 participants from the islet transplant waiting list~     at the Clinical Islet Transplant Program. All participants will receive islets isolated with~     the medication BMX-010. This is to assess the primary safety of BMX-010 on pancreata and~     islets. BMX-010 will be used only in the islet isolation process, and will not be given to~     participants as medication.~   "
45774|NCT02457845|"~     This study is a clinical trial to determine the safety of injecting G207 (a new experimental~     virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207~     with a single low dose of radiation, designed to enhance virus replication and tumor cell~     killing, will also be tested. Funding Source - FDA OOPD~   "
45775|NCT02457832|"~     The purpose of this research study is to learn more about brain activity when individuals~     with and without Parkinson disease (PD) move their lower limbs. The investigators also want~     to see if and how two different types of partnered dance affect brain activity in~     individuals with and without PD. Testing will take place at the Atlanta VA Medical Center~     and at Emory University. The investigators expect to enroll about 140 people for this study~     over a five-year period.~   "
45776|NCT02457819|"~     This is an open label 26 week extension study for subjects who completed SEP360-202.~   "
45777|NCT02457806|"~     To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist~     administered unilaterally with respect to global profound pulpal anesthesia in target teeth~     numbers 4-13.~   "
45778|NCT02457793|"~     This is a two-stage dose-escalation study to assess the safety, tolerability and effects of~     oral dosing of cobimetinib and GDC-0994 administered in combination in patients with~     histologically confirmed, locally advanced, or metastatic solid tumors for which standard~     therapies either do not exist or have proven ineffective or intolerable.~   "
45779|NCT02457780|"~     Many responders to the World Trade Center (WTC) disaster continue to experience significant~     mental and physical health problems. Two of the most common health problems, post-traumatic~     stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health~     conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The~     primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and~     respiratory symptoms.~   "
45780|NCT02457767|"~     In this study the investigators measure and optimize the patients waiting time in the~     preanesthetic assessment by integrating an interactive mobile device. The aim of this study~     is to observe whether the patients mean waiting-time is reduced by the use of a special~     mobile application (Anaest-App) and, as a result , raises patient-satisfaction.~   "
45781|NCT02457754|"~     Several studies have shown a high association between physical fitness and present and~     future health. Two of the main epidemics of the industrialized world are obesity and~     osteoporosis, diseases that could be prevented with early interventions from childhood.~     Both, physical activity and physical fitness have shown an association with these diseases,~     but tools for assessing them in early ages are still in development. Moreover, there is a~     lack of physical fitness reference values in preschool children and the relation of~     pathologies with physical fitness in these ages is still to be demonstrated. Therefore,~     through a simple and precise methodology displayed in the school and adapted for the younger~     we intend to: Provide a combination of safe and precise field tests to evaluate health~     related physical fitness in preschool children. Analyze body composition, risk of~     overweight, obesity and low mineral density and their relation with physical activity. The~     evaluation of these health-related physical fitness variables in early ages is of great~     interest to clinic and public health.~   "
45782|NCT02457741|"~     This study will test the validity of a new approach to assess alveolar recruitability at the~     bedside in comparison to direct measurements of lung volume and derecruitment.~   "
45783|NCT02457728|"~     Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.~   "
45784|NCT02457715|"~     This is a parallel group, single institution, prospective clinical study. The purpose of~     this study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a~     feasible tool to study physical activity in cancer patients and patients with Amyotrophic~     Lateral Sclerosis (ALS).~   "
45785|NCT02457702|"~     The researchers will recruit patients with liver disease at Parkland Hospital. Patients will~     fast overnight, and the next morning will receive an oral mixture of [U-13C3]glycerol (25~     mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in~     100 milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120~     min after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of~     [5,6-13C2]- and [4,5-13C2]glucose indicates preserved mitochondrial function. The~     researchers anticipate that patients with severe liver disease will show a decrease in~     mitochondrial function and will inform biosynthetic function of liver mitochondria.~      After the first 6 successful exams (see power analysis, below), healthy volunteers (age-,~     gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.~   "
45786|NCT02457689|"~     CUT*HIVTHER 001 is a randomised placebo-controlled Phase I/II study aimed at exploring the~     safety and immunogenicity of two different modes of delivery of a GTU® DNA plasmid vaccine~     (GTU®-multiHIV B clade) in HIV infected volunteers on antiretroviral therapy (ART):~        -  Transcutaneous (TC) delivery to enhance intramuscular delivery and~        -  Electroporation (EP) enhanced intramuscular delivery Participants will be randomised~          1:1:1 to TC:EP:saline for the purposes of analysis. Half the saline group will receive~          TC saline and half will receive EP saline.~           30 HIV infected male and female volunteers aged 18-45 years, who have been on ART for~          at least 6 months with 2 or more HIV plasma viral load measurements < 50 copies HIV~          RNA/ml prior to enrolment.~      The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen which~     is a synthetic fusion protein consisting of full-length polypeptides of Rev, Nef, Tat, p17~     and p24 and containing more than 20 Th and CTL epitopes of protease, reverse transcriptase~     (RT) and gp160 regions of the HAN2 HIV-1 B clade.~      Vaccine is provided in sealed vials at 2mg/ml, and a single 1ml IM injection of 2mg~     GTU®-MultiHIV DNA IM (into the thigh) is required to deliver a 2mg dose. Individuals in~     Group 2 will receive a further 0.4mg GTU®-MultiHIV DNA in 0.2ml administered by TC, a novel~     needle-free method of vaccine delivery.~   "
45811|NCT02457364|"~     Ventral hernias are among the most common surgical diseases among patients.The natural~     history of patients with ventral hernias who are managed non-operatively is unknown. The aim~     of this prospective trial is to document the natural history of patients who are undergoing~     initially non-operative management. The investigators hypothesize that 1) the risk of~     emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is~     high, and 3) patients managed non-operatively will develop increasing hernia size and~     symptom progression. This is a prospective observational study of all patients undergoing~     non-operative management at LBJ General Hospital. Patients will be consented and then~     followed for 5 years. Phone interviews will be done with these patients yearly to assess~     surgical and medical history, information about their hernia, including pain level due to~     the hernia, as well as function and quality of life.~   "
45787|NCT02457676|"~     This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize~     their self-regulation deficits, a process important for controlling emotions and behavior,~     (ii) describe brain structure and function underlying self-regulation, and (iii) determine~     whether training to improve self-regulation abilities changes brain and behavior.~     Individuals with FASD have a high risk of cognitive and social deficits, which reflect their~     difficulties in self-regulation and may lead to mental health concerns in adulthood.~     Importantly, early intervention improves long-term outcome. However the full extent of~     self-regulation problems in FASDs is unknown and the underlying neuroanatomy has not been~     fully described. Furthermore, information on how to best treat children with FASDs is~     lacking. Thus, the investigators propose three studies with a sample of 8-12 year old~     children, 40 with FASDs and 20 typically developing controls. In Study 1, the participants~     will be evaluated on cognitive and social self-regulation abilities using clinical and~     experimental tests. In Study 2, the participants will undergo a 1-hour MRI scanning session~     to obtain measures of their brain structure and function. In Study 3, FASDs will be randomly~     assigned to an immediate or delayed treatment group. The immediate group will undergo~     12-weeks of therapy with the Alert Program for Self Regulation®. On conclusion of training,~     all will repeat Studies 1 and 2 and following this retest, the delayed treatment group will~     undergo training. The investigators will evaluate change in cognitive and social behavior~     and in brain structure and function by comparing performance and neuroimaging findings~     before and after the intervention. The investigators expect Alert training to significantly~     improve behavior and alter brain regions important for self-regulation. The findings will~     yield important information for improving self-regulation in FASDs and mitigating the~     development of mental health challenges.~   "
45788|NCT02457663|"~     In this prospective, multi-center study, 200 patients from four participating Texas burn~     hospitals will be enrolled from admission to discharge. The clinical research study team~     will collect approximately 11 serum samples and clinical data related to sepsis and~     infection predictors from severely burned adult patients, ages 18-80 years old. All serum~     samples from participating sites will be shipped to the lead site, University of Texas~     Medical Branch. The University of Texas Medical Branch will then validate previously~     identified biomarkers while simultaneously identifying novel biomarkers through discovery~     proteomics.~   "
45789|NCT02457650|"~     Background:~      Autologous T cells engineered to express a T cell receptor (TCR) targeting NY-ESO-1 will be~     infused back to patients with NY-ESO-1- expressing malignancies. The patients pretreated~     with a lymphodepleting preconditioning regimen will be monitored after infusion of~     anti-NY-ESO-1 TCR-transduced T cells for adverse events, persistence of anti-NY-ESO-1~     TCR-transduced T cells and treatment efficacy.~      Objectives:~      To evaluate the safety and the efficacy of anti-NY-ESO-1 TCR-transduced T cell-based~     immunotherapy for patients with NY-ESO-1- expressing malignancies.~      Eligibility:~      Patients older than one year of age, who have relapsed or refractory malignancies that~     express both NY-ESO-1 and human leukocyte antigen (HLA)-A2 molecules.~      Patients must have adequate organ functions.~      Design:~        -  Peripheral blood from patients will be collected for isolation of peripheral blood~          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral~          vector encoding an HLA-A2 restricted anti-NY-ESO-1 TCR gene.~        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune~          system to accept modified T cells.~        -  Patients will receive an infusion of their own modified T cells. They will remain in~          the hospital to be monitored for adverse events until they have recovered from the~          treatment.~        -  Patients will have frequent follow-up visits to monitor the persistence of modified T~          cells and efficacy of the treatment.~   "
45790|NCT02457637|"~     Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute~     deterioration of liver function, culminating in multiple organs failure and high short-term~     mortality. Currently, there are differences in definitions and descriptions between western~     and eastern types of ACLF, especially in the definition of chronic liver disease and its~     precipitating events. The CANONIC (EASL-CLIF Acute-on-Chronic Liver Failure in Cirrhosis)~     study put forward CLIF-SOFA (chronic liver failure-sequential organ failure assessment)~     scores as the clinical diagnostic criteria of ACLF in 2013. Although the Asian Pacific~     Association for the Study of the Liver (APASL) reached a consensus for diagnostic criteria~     of ACLF in 2008, which is however based on expert opinion, rather than prospectively~     collected and validated data. To clarify the eastern type of ACLF (HBV related) and~     establish whether the eastern and western (alcoholic related) types of ACLF are homogenous,~     the investigators are launching this prospective multicenter clinical trial. The~     investigators are going to identify three key points: (1)Whether HBV and non-HBV ACLFs are~     belong to a homogenous disease entity which share the same diagnostic criteria, disease~     grades classification and prognostic model; (2) Whether acute deteriorating patients from~     cirrhosis or from mild fibrosis (S1-S2) belong to a homogenous entity? (3)To clarify if~     there are heterogenous groups in APASL criteria diagnosed ACLF patients.~      13 Chinese national wide liver centers each of whose total beds are around 500 have been~     included. Extra liver centers may join later. Continuous hospitalized chronic liver disease~     patients of various etiologies (including both cirrhotic and non-cirrhotic) with acute~     decompensation (AD) or acute hepatic injury (ALI) (aminotransferase > 3NL(normal level))~     will be recruited from January to December 2015. Biochemical parameters, organ failure,~     mortality and liver transplantation rate will be collected and evaluated at day 1,4,7,14,21~     and 28 after enrollment. Considering there will lack of liver biopsy in most of the~     patients, both CT and FibroScan as supplementary methods will be used for differentiating~     non-cirrhotic patients, especially hepatitis patients with mild fibrosis, from cirrhotic~     patients. The patients will be continuously followed up once a month until the 24th month~     after hospital discharging. During follow-up, patients will be hospitalized again whenever~     they have new ALI or AD. Similar data will be collected reference to their prior admission~     and follow-up will restart. Through continuous collection, the investigators will acquire~     data about the patients from stable chronic liver disease to deterioration of the disease.~     Then these data will be analyzed according to the questions that the investigators hope to~     resolve.~   "
45791|NCT02457624|"~     Experienced endoscopists will perform endoscopy during the study period and the detection~     rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis~     of premalignant lesions and inter-observer agreement rate will be analyzed before and after~     the education.~   "
45792|NCT02457611|"~     This study will evaluate the efficacy, safety and tolerability of ledipasvir/sofosbuvir~     (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C~     virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.~   "
45793|NCT02457598|"~     This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics,~     and preliminary efficacy of ONO/GS-4059 in combination with other targeted anti-cancer~     therapies in adults with relapsed or refractory B-cell lymphoproliferative malignancies.~      This study consists of two parts: Dose Escalation and Dose Expansion. During the dose~     escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose~     escalation study design, to receive oral ONO/GS-4059 combined with idelalisib entospletinib~     +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single~     B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety,~     tolerability, PK, and pharmacodynamics.~   "
45794|NCT02457585|"~     Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.~      This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled~     patients will be 11~   "
45795|NCT02457572|"~     Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid~     responsiveness. However, its usefulness in open-chest conditions has been equivocal. The~     investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid~     responsiveness after sternotomy.~   "
45800|NCT02457507|"~     Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic~     people. Vitamin B12 deficiency in older people is associated with cognitive impairment and~     Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in~     older diabetic people.~      Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively~     normal older diabetic people reduces the incidence of cognitive decline.~      Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal~     diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in~     medical and family medicine/ general outpatient clinics.~      Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and~     without family member who can reliably inform on cognitive functioning (personal contact at~     least once a week), eligible patients will be invited to participate in this clinical trial.~     After obtaining written consent, research assistant (RA) will record demographic and~     clinical information from the subjects and perform neuropsychological tests - 1. Clinical~     dementia rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini~     mental state examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be~     taken for serum methylmalonic acid (MMA). Those with cognitive impairment and significant~     comorbidities will be excluded.~      264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram~     or two identical looking placebo tablets once daily for 27 months.~      All subjects or family caregivers are reviewed in the research clinic every 12 weeks in~     which the research assistant performs a pill count and dispenses the trial tablets. At 9~     monthly intervals, the subjects will have neurocognitive test battery repeated at research~     clinic. CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and~     vitamin B12 will be repeated.~   "
45801|NCT02457494|"~     The purpose of this study is to define the cause of renal stones and the risk pattern for~     recurrence of renal stones episodes (any kind of stones) in HIV1 patients.~   "
45802|NCT02457481|"~     The purpose of this research study is to evaluate a newly developed embryo culture media~     system for human clinical use in ART.~   "
45803|NCT02457468|"~     The purpose of the coflexCOMMUNITY observational study is to collect information on patients~     with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their~     outcomes and the cost-effectiveness of this procedure.~   "
45804|NCT02457455|"~     The aim of this study is to evaluate the incidence and status of urgent medical conditions.~     After defining the urgent situations, the investigators will evaluate the adequacy of the~     standard medical kits and trainings.~   "
45805|NCT02457442|"~     Recently a new model for the interaction of sevoflurane propofol and remifentanil was~     developed. The potency of any combination of the three drugs is defined as probability that~     a subject tolerates laryngoscopy without movement response. The model allows to compare the~     potency of intravenous and inhalation anesthetics. If the model is valid also for other~     stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate~     increase upon stimulation). If the model is valid equipotent concentrations of sevoflurane~     and propofol the same remifentanil concentration would be sufficient to suppress hemodynamic~     response to a given stimulus. This will be investigated it the study.~   "
45806|NCT02457429|"~     Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a~     variety of symptoms in both adult and paediatric populations. In children the effects of~     refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory~     factor in the underlying pathological processes of a number of conditions including apnoea,~     asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The~     absence of typical symptoms in addition to the inability to obtain a formal symptom history~     from a young paediatric population contributes to the difficulty in establishing a~     diagnosis. At present there are no studies or data directly measuring extraoesophageal~     reflux and its correlation to oesophageal pH monitoring in children.~      The use of twenty-four hour oesophageal pH monitoring is regarded as the established~     technique for diagnosis of GORD, however this technique has been less reliable for detecting~     extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a~     sensitive and minimally invasive transnasal device, to assess the feasibility and validate~     its use in a paediatric population.~   "
45807|NCT02457416|"~     The purpose of the study is to identify prognostic markers and possible success rate of~     tolerance induction to peanut allergens in children allergic to peanut.~   "
45808|NCT02457403|"~     A prospective, randomized clinical trial comparing blood product use and bleeding events~     during and after endoscopic or neurosurgical procedures in patients with cirrhosis and~     coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).~   "
45809|NCT02457390|"~     Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon~     and rectum (CRC) has been shown to be able to detect liver metastasis that are not~     recognized by conventional computer tomography (CT scan) prior to surgery.~      Today most of the colorectal cancer resections are performed by laparoscopy, but robotic~     technology is gradually developed in an attempt to overcome some of the limitations~     characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound~     examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied,~     and this despite the fact that it seems technically possible to perform.~      With this project we will investigate whether CE-LUS associated with robotic surgery for CRC~     is technically feasible and whether it will be able to detect synchronous liver metastases~     that have not been detected on the preoperative imaging modalities.~   "
45810|NCT02457377|"~     A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt~     needles, is introduced into the abdominal cavity through the 5-mm trocar. However,~     flattening the curvature of the needles, while introducing the tape into the abdomen, will~     eventually pose a challenge during placement of the stitch (the needles' curvatures~     guarantee that the tissue penetration is done away from the uterine vessels).~      To overcome this problem, the following method was devised. A one cm suprapubic incision is~     made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the~     needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A~     grasper from one of the flank ports receives the tip and the needle is delivered carefully~     (FIGURE 1). The rest of the tape is pulled until the blunt end of the other needle appears,~     to be delivered in the same way but in the reverse order.~      • Operative Steps The vesico-uterine peritoneum is opened using scissors & the urinary~     bladder is dissected downwards from the lower uterine segment to expose the uterine vessels~     anteriorly on both sides . Both needles are passed through the lower uterine tissue medial~     to uterine vessels on the right & left sides (from anterior to posterior) . Then, both~     needles are passed through the remaining cervical tissue medial to uterosacral ligaments~     towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic~     illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull~     them through the posterior vaginal fornix . After trimming of both needles, the Mersilene~     tape is tied tightly behind the intravaginal segment of the cervix with five knots & the~     ends of the stitch are trimmed. The vesico-uterine peritoneum is then reapproximated over~     the laparoscopic cerclage with a running (00) Monocryl suture that is tied intracorporeally.~   "
45812|NCT02457351|"~     To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics~     of roniciclib in cancer patients.~      To assess safety and tolerability of roniciclib dosing when administered with and without~     itraconazole in cancer patients~   "
45814|NCT02457325|"~     The present clinical trial randomized compared the clinical efficacy of the local~     anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000~     adrenaline, for the removal of lower third molars. Onset, duration of postoperative~     analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding,~     hemodynamic parameters, postoperative mouth opening and wound healing at the 7th~     postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal~     of symmetrically positioned lower third molars, in two separate appointments (one to two~     months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000~     adrenaline) in a double-blind, randomized and crossed manner.~   "
45815|NCT02457312|"~     The present study aims at studying the effect of letrozole in early pregnancy in placenta~     and decidua including the progesterone receptor and the apoptotic factors.~   "
45816|NCT02457299|"~     This multi-center, randomized prospective clinical trial involves esophageal cancer patients~     who are surgical candidates. Patients will be randomized either to the one stage or the two~     stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost~     analysis from both types of procedure will be reviewed and compared.~   "
45817|NCT02457286|"~     Metformin is being compared to exercise and diet modifications. The researchers are~     interested in learning if the addition of metformin to lifestyle modifications is more~     helpful in treating the condition or disorder. Although metformin is FDA approved to treat~     type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver~     (NAFLD) and is considered investigational for the purpose of this study.~   "
45818|NCT02457273|"~     Title of Study:~      An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy~     and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated~     Neuroendocrine Carcinomas~      Investigational product:~      Lipotecan®*~      *Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor)~      Phase of development:~      Phase II~      Number of subjects:~      Plan to enroll 44 subjects~      Objectives:~      Primary objectives:~      To determine the objective response rate~      Secondary objectives:~      To evaluate Disease control rate, Progression free survival, Overall survival, Safety~     profile and Biomarkers~   "
45819|NCT02457260|"~     Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis~     in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during~     steady state exercise. Our own work has demonstrated safety and efficacy of an FDA~     investigational new drug (IND) approved sodium nitrite (10 milligram [mg]) capsule, and its~     utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP)~     pathway of skeletal muscle of younger heart failure (HF) patients. It now seems~     exceptionally logical and opportune to apply these insights to older HF patients and to~     delineate mechanisms of disease and aging that respond to nitrite therapy.~   "
45820|NCT02457247|"~     The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing~     500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium~     and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing~     500 mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium~     and 800 IU of vitamin D) in Test Group 2.~   "
45821|NCT02457234|"~     The purpose of the Traditions study was to examine the influence of cultural immersion on~     willingness to try fruits and vegetables among children, 3-12 y, in Guam. The primary~     objective of this study was to examine willingness to try fruits and vegetables and fruit~     and vegetable intake among children attending three existing summer camp programs: a~     cultural immersion camp, a university day camp, and a recreational sports camp. The primary~     hypothesis was that children attending the cultural immersion camp would have higher~     willingness to try fruits and vegetables (WillTry score) and a higher intake of fruits and~     vegetables compared to children attending both, the university day camp and recreational~     sports camp, without cultural immersion.~      A pre-post, quasi-experimental design was used to evaluate 3 summer camps with different~     exposure levels of cultural immersion. High, moderate, and zero (cultural) exposure was~     provided by a cultural immersion camp (CIC), a university-based day camp (UDC), and a~     recreational sports camp (RSC), respectively. CIC delivered 4 culturally adapted nutrition~     lessons within the context of Chamorro cultural traditions as part of the cultural immersion~     camp activities. The UDC delivered the same lessons within a physiology framework. The RSC~     was without nutrition lessons and cultural immersion. Children 3-12 years old registered in~     any of the three summer camp programs were eligible to participate. Data collection was~     primarily administered at two assessment periods: before (± 2 weeks) and after (± 1 week)~     each summer camp program. Children's willingness to try fruits and vegetables, the primary~     outcome, was assessed with the interview-administered Adapted WillTry tool. The secondary~     outcome was fruit and vegetable intake as servings/day in the CIC to UDC only. Fruit and~     vegetable intake was assessed using the mobile food record (mFR), which is an app running on~     an iPod Touch based on the technology assisted dietary assessment (TADA) protocols. Outcomes~     examined Adapted WillTry post-scores for local novel and local common fruits and vegetables~     and fruit and vegetable servings/day using multivariate regression models adjusting for the~     relevant pre-score, sex, age, ethnicity, dose, BMI percentile, and parent's cultural~     affiliation. Therefore, additional measures like sociodemographic information, anthropometry~     (i.e. heights and weights), and parent's cultural affiliation were collected to account for~     potential confounders.~   "
45822|NCT02457221|"~     The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules~     for induction remission in patients with lupus nephritis, and compare the efficacy and~     safety with Cyclophosphamide injections.~   "
45823|NCT02457208|"~     This is a prospective descriptive and pharmacokinetic study will be conducted among newly~     diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border.~     This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV~     co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per~     WHO guidelines.~   "
45824|NCT02457195|"~     The objective of the study is to evaluate the efficacy and safety of adding transdermal~     preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting~     (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the~     previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing~     surgical procedure under general anesthesia.~      The specific aims of the study include:~        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after~          surgery~        2. incidence and seriousness of the observed side effects~        3. ability of patients to self-administer preoperatively and maintain the investigated~          patch during the perioperative period~        4. level of satisfaction with the preoperative PONV prophylaxis.~   "
45825|NCT02457182|"~     Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with~     unreliable treatments. Although it is not known what causes it for certain, we do know that~     life stressors may make the disease worse or cause flares. Mindfulness Based Stress~     Reduction (MBSR) is an 8 week class focused on meditation and other techniques that the~     investigators think may be helpful to people with IC/BPS. This trial will assign~     participants to an MBSR class or usual care for their IC/BPS to see if the MBSR class would~     be helpful for their disease.~   "
45826|NCT02457169|"~     The intervention under examination is designed to promote parents' school engagement~     following the transition from Early Intervention (EI) to preschool for parents of young~     children who were diagnosed with ASD through our screening and assessment protocol. The~     brief intervention employs principles of motivational interviewing to address not only the~     particular child characteristics and needs associated with ASD but also the unique,~     system-related challenges of navigating the special education system and advocating for~     appropriate services. Motivational interventions with parents are designed to elicit~     parents' specific, action-oriented goals for themselves and their children, enhancing~     motivation to pursue change, and addressing and resolving obstacles or sources of~     ambivalence.~      By identifying and capitalizing on parents' strengths, empowering parents to develop~     specific goals, and improving parents' readiness to engage actively with their children's~     school, teacher, and educational team, we expect that this brief intervention will lead to~     higher levels of parental school involvement, higher special education engagement, and~     closer and more productive parent teacher relationships.~   "
45827|NCT02457156|"~     The purpose of this study is to compare two different techniques of performing a pancreatic~     anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces~     pancreatic remnant leak, post-operative complications and overall length of hospital stay.~   "
45828|NCT02457143|"~     This randomized trial aims to understand how effective a reminder letter is compared to a~     reminder phone call in improving breast, cervical and colorectal cancer screening rates and~     reducing screening disparities.~   "
45829|NCT02457130|"~     Patients with type 2 diabetes mellitus (T2DM), have a high prevalence of suboptimal response~     to clopidogrel (up to 40%). This impaired response to antiplatelet drugs has been~     consistently associated with a higher risk of adverse ischemic outcomes. Different~     strategies have been suggested to overcome variability in response to clopidogrel and~     improve clinical outcomes in diabetic patients. One of these strategies is the use of newer~     P2Y12 inhibitors, such as ticagrelor, with more potent and consistent platelet inhibitory~     effects compared to clopidogrel. In summary, since patients with T2DM continue to have~     enhanced platelet reactivity despite the administration of commonly used dual antiplatelet~     therapy with aspirin and standard doses of clopidogrel, newer and more potent antiplatelet~     treatment strategies are warranted in this high-risk population. The purpose of the present~     study is to compare platelet inhibitory effects achieved with ticagrelor versus clopidogrel,~     both on top of aspirin therapy, in patients with type 2 DM and stable coronary artery~     disease.~   "
45830|NCT02457117|"~     This study is a registry to monitor quality of life and clinical outcomes in patients with~     clinically localized breast cancer who have received stereotactic accelerated partial breast~     irradiation via CyberKnife.~   "
45831|NCT02457104|"~     The investigators long-term goal is to understand how PPIs influence energy balance in both~     obese and normal-weight individuals. The overall goal of this study is to determine whether~     PPI use causes detrimental changes in the composition and functional properties of the gut~     microbiome, and whether any such effects are mediated by altered responses of human fatty~     acid receptors (e.g., GPR41/43).~   "
45832|NCT02457091|"~     The purpose of this study is to test different types of exercise training for people with~     multiple sclerosis (MS). The exercise program is based on physical activity guidelines that~     have been developed specifically for people with MS. The investigators believe these~     guidelines will be effective for improving physical fitness and function in persons with~     mild-to-moderate MS.~   "
45833|NCT02457078|"~     This project will investigate whether adding nutritional supplements to the diet will have~     beneficial effects on the development of infant brain networks (assessed at 4 and 9 months~     of age). The nutritional supplement will contain lutein (typically found in leafy~     vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such~     as salmon or tuna), and of vitamin E.~   "
45834|NCT02457065|"~     A patient's sun-related behavior greatly influences the likelihood of that patient~     developing melanoma, the most dangerous form of skin cancer. Prior research shows current~     education strategies on inducing preventative behaviors such as wearing sun-protection~     clothing and wearing sunscreen are inadequate at effectively changing behavior when used in~     isolation -- patients are aware of the dangers of not engaging in these preventative~     measures but forgo them nonetheless.~      We are investigating methods to positively influence sun protection behaviors among melanoma~     survivors and their families. The first objective is to compare patient and familial sun~     exposure and cancer screening activity before and after patients' diagnosis with primary~     melanoma. The second objective is to note if hanging a Melanoma Survivor plaque in a~     melanoma survivor's bathroom will significantly affect the survivor's and broader family's~     sun exposure and cancer screening activity.~      Our sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm~     in depth who come through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and~     voluntarily choose to participate in the study after being informed of the nature of the~     research. These patients complete a confidential survey assessing a change in sun exposure~     related activities immediately after their diagnosis. After they fill out the survey, we~     will ask them if they could nominate a family member to whom we will explain the purpose of~     our research and confidentially ask an additional set of questions to evaluate the broader~     impact of a melanoma diagnosis. From our original sample, we will randomly choose a few~     families who would display the survivor plaque in their primary bathroom. After six-twelve~     months, during the patient's follow up visit, will ask again both groups of patients and~     family members to fill out another survey to assess sun exposure related activity.~      On the surveys, no names are recorded. Everything is anonymous.~   "
45835|NCT02457052|"~     When the seat is a vehicle for disabled person, postural adaptation methodology is known~     and, on prescription, there is possibility of financial support for technical posture~     assists. For people who use a standard seat, a chair for example, there is no satisfactory~     existing hardware.~      A transportable customisable and scalable sitting positioning device (DATP device), to be~     placed on a standard seat, is a solution that might fit in the home, in specialized foster~     homes or in institutions for the elderly. Such a device has been developed but earnings on~     swallowing disorders have to be validated.~   "
45848|NCT02456883|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib,~     in particular, the routes of excretion and extent of metabolism of gilteritinib following~     administration of a single dose of 14C-labeled gilteritinib after repeated doses of~     gilteritinib.~      This study will also evaluate the safety of repeated oral administration of gilteritinib in~     subjects with advanced solid tumors as well as identify the metabolic profile of~     gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled~     gilteritinib.~   "
45849|NCT02456870|"~     The purpose of this pilot study is to determine whether adipose tissue loses some of its~     ability to expand in response to overfeeding in older compared to younger men. The~     investigators hypothesize that the adipose tissue response to overfeeding may be weakened in~     older when compared to younger men, thereby leading to worsened ectopic storage depots for~     older men.~   "
45836|NCT02457039|"~     Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive~     impairment symptoms, including problems with visual and verbal memory, forgetfulness,~     difficulty in learning, attention, concentration and coordination of multitasking and~     organization. Over 75% cancer patients experienced acute cognitive symptoms during~     chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can~     persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence~     of post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life~     issue for cancer survivors and will be encountered more frequently with the rise of the~     number of cancer survivors. There are no effective interventions available for preventing~     and treating chemobrain.~      Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also~     shows the efficacy in improving mild cognitive impairment and other dementia disorders;~     facilitates the recovery of pathological microstructural changes of the brain. These results~     have led to the hypothesis that acupuncture is effective in preventing chemobrain and this~     preventive effect may be associated with the protection against cytokine production,~     epigenetic modification and microstructural changes of the brain.~      To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted~     to determine if a combination of DCEAS and body acupuncture could reduce the incidence and~     symptoms of chemobrain in breast cancer patients under chemotherapy compared to least~     acupuncture stimulation (LAS) as controls.~      A total of 168 breast cancer patients who are ready for chemotherapy will be randomly~     assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture~     regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least~     acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients~     receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive~     performance, fatigue and the depression will be assessed.~   "
45837|NCT02457026|"~     The purpose of this prospective interventional study is to assess whether adjunctive~     verteporfin photodynamic therapy (PDT) is effective for the treatment of persistent disease~     activity in neovascular age-related macular degeneration (NV AMD), as compared to anti-VEGF~     therapy (aflibercept) alone. This study will enroll individuals with NV AMD who have~     persistent disease activity in spite of either loading dose (initial 3-5 anti-VEGF~     treatments) or maintenance (established course) anti-VEGF therapy to determine whether PDT~     can improve disease activity, facilitate sustained visual acuity gains, and decrease burden~     of frequent anti-VEGF treatments for affected patients. Risks of study are related to~     treatment with study drugs: intravenous verteporfin, intravitreal triamcinolone acetonide,~     and intravitreal aflibercept. All have been studied extensively in clinical trials and are~     established treatments used routinely in NV AMD. Adverse events will be monitored by the~     principal investigator and study team.~   "
45838|NCT02457013|"~     1. The purpose of the study is to evaluate prospectively the clinical benefits of High~          flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway~          pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.~        2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.~        3. Design: Infants less than 6 month admitted in pediatric intensive care unit for~          respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical~          ventilation will be randomized in two groups: n-CPAP(nasal continuous positive airway~          pressure) or HFNC during 24 hours.~        4. Conditions of measurements:~           Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure~          criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or~          respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and~          above 4) or apnea.~           Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate,~          EDIN score, skin lesions, FiO2 (fraction of inspired oxygen~           ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2~          (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2~          / FiO2~        5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142~          children.~        6. Study Schedule: October 2014-April 2016~   "
45839|NCT02457000|"~     The purpose of this study is to explore the mechanisms behind how sleep quality may affect~     skin aging, skin integrity and skin disease.~   "
45840|NCT02456987|"~     This study is being conducted as a pilot to test the feasibility, usability, acceptability,~     and clinical utility of using a virtual reality (VR) immersion experience in the inpatient~     setting. In addition to determining whether the patients enjoy the experience and would like~     to participate in a future more tailored immersion in virtual reality, we will be attempting~     to determine whether there are any positive impacts on their visit, including a distraction~     from their pain or anxiety associated with their procedures or the reason they have been~     admitted to the hospital.~      Because the inpatient population at Cedars-Sinai Medical Center (CSMC) is dynamic and~     diagnostically diverse, we intend to develop a series of VR interventions that broadly~     address patient concerns. VR has only been tested in select patient populations, so we are~     equally interested in the feasibility of deploying VR across the inpatient hospital~     environment as we are in demonstrating some effectiveness in reducing pain and anxiety, and~     improving satisfaction.~      The present study has the following aims:~        1. Adapting existing VR environments for inpatients with a variety of impairments,~          utilizing cost-effective VR hardware (Phase 1).~        2. Assess the usability and acceptability of the VR equipment and software by hospital~          inpatients by conducting qualitative interviews (Phase 2).~        3. Assess the clinical utility of the VR intervention by measuring patient reported~          outcomes using a modified care satisfaction survey, administered to inpatients~          receiving VR and a matched control sample (Phase 3).~      Concerning Aims 2 and 3, we hypothesize the following:~        1. Inpatients will find the VR intervention helpful and enjoyable, and will believe that~          its benefits outweigh any difficulties encountered using the hardware or software.~        2. Inpatients who are exposed to the VR intervention will report significantly improved~          pain management, greater satisfaction with their inpatient visit, and greater overall~          health compared to matched control inpatients that were not exposed to VR.~   "
45841|NCT02456974|"~     Pharmacokinetics of antibiotics in critically ill neonates, infants and children~   "
45842|NCT02456961|"~     The standard CXL technique involves removal of the epithelium to enable riboflavin to~     penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's~     comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis~     of riboflavin is one of approach for riboflavin impregnation.~      In this study, the investigators compared the results of standard corneal crosslinking (CXL)~     and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.~   "
45843|NCT02456948|"~     This study examines the antidepressant efficacy of minocycline as an adjunct to an~     antidepressant standard treatment with es-/citalopram, venlafaxine or mirtazapine~     monotherapy (AD-ST), for patients with unipolar major depressive disorder (MDD).~   "
45844|NCT02456935|"~     The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD),~     compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8~   "
45845|NCT02456922|"~     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in~     subjects age 2 - 75 years~   "
45846|NCT02456909|"~     To examine whether providing patients with a cue to the availability of pain medication~     affects patient satisfaction, patient anxiety, PCA efficacy, and safety.~   "
45847|NCT02456896|"~     The present study has been designed to evaluate the change in serum BDNF level with~     oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its~     neuroprotective effect.~   "
45853|NCT02456818|"~     This study aims to evaluate the impact of contact isolation on the rate of hospital-acquired~     transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and~     infection. On the basis of this study, it will be possible to re-evaluate the need for~     contact isolation for patients colonized or infected with ESBL-EC.~   "
45854|NCT02456805|"~     This study assessed tolerance improvement of a formula change in healthy term infants with~     perceived intolerance to their current milk-based formula feeding.~   "
45855|NCT02456792|"~     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus~     laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC)~     resistant polycystic ovarian syndrome (PCOS).~   "
45856|NCT02456779|"~     The primary objective of this clinical study is to determine whether Peptest (Human Pepsin~     lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic~     methods commonly applied in clinical practice by testing a large number of clinical samples.~      This will be performed by evaluating Peptest results in GERD patients (Erosive esophagitis~     or NERD), defined using standard clinical procedures, and compared to healthy controls.~   "
45857|NCT02456766|"~     This will be a multi-center, prospective, controlled study. It is expected that about 240~     subjects from 10 study centers will be enrolled, and 224 effective subjects will be~     statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56~     effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56~     effective subjects with stage F3 (25%). By comparison of the result of FibroTouch~     examination with that of liver biopsy, their specificities, sensitivities and accuracies for~     diagnosis of liver steatosis will be identified.~      The patients with liver diseases who need to have a liver biopsy in hospital and meet all of~     the inclusion criteria and none of the exclusion criteria, may participate in this study.~     Within two weeks of FibroTouch examination, subjects are required to have qualified~     histological specimens of liver biopsy for comparation.~   "
45858|NCT02456753|"~     The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can~     help to visualize elements that may not be observable after clinical examination. Moreover,~     it is known that a fetal head engagement can lead to an instrumental extraction and in case~     of error, which happens in some cases, fetal and maternal risks are possible.~      These elements led to the investigators' hypothesis which is that a trans-perineal~     ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of~     doubt.~   "
45859|NCT02456740|"~     Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study~     followed by active-treatment phase. To evaluate the effect of AMG 334 compared to placebo on~     the change from baseline in monthly migraine days.~   "
45860|NCT02456727|"~     Chronic pain is a major public health problem that places many burdens on individuals,~     including impairment of physical and psychological functioning, lost productivity, and side~     effects of medications used to treat pain. There is also substantial evidence that minority~     populations differ both in prevalence and outcomes of chronic pain; access to care is a key~     component in these differences. Strong evidence now supports the use of acupuncture in the~     treatment of chronic pain conditions, including when provided in the primary care setting to~     patients from ethnically diverse, medically underserved populations. Acupuncture is slowly~     being integrated into pain management in many conventional health care settings, but cost~     and reimbursement for this service remain obstacles to offering acupuncture, especially in~     primary care and safety net settings. Because group acupuncture can be offered at much lower~     cost, demonstrating that individual and group delivery are equally effective could reduce~     barriers to use of this effective pain management approach.~      The primary aim of this study will be to evaluate whether acupuncture delivered in the group~     setting for patients with chronic pain is equal to acupuncture delivered in the individual~     setting. A secondary objective will be to use qualitative analysis to understand and~     describe the patient experience of both acupuncture approaches, and to utilize this data to~     inform intervention delivery and dissemination, to better incorporate the patient~     perspective.~   "
45861|NCT02456714|"~     Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor~     prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a~     phase III clinical study, cisplatin plus gemcitabine is considered standard first-line~     treatment in advanced cholangiocarcinoma patients, but there is no established second line~     therapy.~      Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX)~     appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic~     cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could~     be an effective second-line treatment for patients with advanced cholangiocarcinoma.~   "
45862|NCT02456701|"~     This is a patient pilot study testing the hypothesis that vemurafenib with the addition of~     KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR)~     thyroid cancer patients.~   "
45863|NCT02456688|"~     This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in~     patients with impaired hepatic function as compared to healthy volunteers.~   "
45864|NCT02456675|"~     A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy~     and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or~     refractory Hodgkin Lymphoma.~   "
45875|NCT02456532|"~     This proposal will assess risks for transition from therapeutic hypnotic use to abuse in~     people with insomnia. The investigators will study a hypothesized at-risk sub-population,~     insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects,~     eszopiclone, versus one without mood effects, zolpidem.~   "
45940|NCT02455687|"~     Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and~     inhaled steroids beside the standard treatment for patients with severe asthma attacks.~      Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without~     inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and~     decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children~     with severe asthma attacks,compared to single dose of magnesium sulfate with or without~     inhaled budesonide.~   "
45865|NCT02456662|"~     Background/Purpose of the Study Doxycycline is an antibiotic used for infection prevention~     before surgical pregnancy termination, and a side effect of it is nausea/vomiting. The~     investigators' study explores whether or not taking the anti-emetic ondansetron prior to~     doxycycline decreases rates of nausea/vomiting. Patients enrolled in the investigators'~     study will take either ondansetron or a placebo before they take doxycycline to see if~     ondansetron decreases their nausea/vomiting. Reducing nausea/vomiting may prevent more~     infections, and decrease the rates of general anesthesia, patient risks and hospital costs.~     Decreasing nausea/vomiting will also improve patient experience.~      Study Design This will be a randomized controlled trial. Data will be collected by~     administrating surveys and a log where patients will record the timing of their medications~     and episodes of nausea/vomiting. The primary outcome is nausea/vomiting after taking the~     anti-emetic/placebo and doxycycline. 400 eligible patients will be enrolled over two years,~     200 in the intervention group and 200 in the placebo group.~      Rationale for Study Design A randomized controlled trial will be used to determine the~     effects of the anti-emetic ondansetron on rates of nausea/vomiting.~      Subject Characteristics Patients will be pregnant females, 18-45 years old, who are~     undergoing surgical termination of pregnancy.~      Design 1-2 days before the procedure, patients will complete a demographic questionnaire and~     a survey about symptoms of nausea/vomiting. They will use a log to record symptoms they~     experience between taking the anti-emetic/placebo and when they present for their procedure.~     When patients come to the hospital, they will fill out a repeat survey rating their~     nausea/vomiting.~   "
45866|NCT02456649|"~     The combination of breast conserving surgery (lumpectomy) with radiation therapy has been~     shown to result in equivalent overall survival rates compared to mastectomy for the local~     treatment of breast cancer. As a result, the majority of patients diagnosed with breast~     cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple~     studies have demonstrated the association between positive lumpectomy margins and an~     increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation.~     Studies report 20-40% of lumpectomy procedures result in one or more involved (positive)~     surgical margins, leading to the need for further surgery, emotional distress, poorer~     cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative~     margin assessment techniques include specimen Xray, gross pathology, frozen section, and~     touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune~     Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative~     assessment of the presence of tumor at the lumpectomy margin. In the current study, the~     investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to~     standard practice for intraoperative identification of tumor at lumpectomy margins, and its~     ability to reduce positive margins and decrease the need for additional surgical procedures.~   "
45867|NCT02456636|"~     The purpose of this study is to compare three methods for managing obesity in rural~     patients, to see which method will result in patients being able to attain their weight loss~     goal and maintain that weight loss.~   "
45868|NCT02456623|"~     The purpose of this study is to preliminarily validate a parent-focused obesity intervention~     program for parents of low-income, African American preschoolers who are currently~     overweight (> 85th BMI %tile). Half of the participants will receive an intervention that is~     eight sessions in length and carried out in the participant's home. The sessions will target~     the nutrition and physical activity knowledge of parents and their motivation for changing~     parenting related to family eating habits and activity level. The remaining participants~     will receive an attention comparison control condition (ACCC), which includes one home~     visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of~     parents receiving the intervention will have decreases in BMI %tile, consume more~     fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to~     ACCC.~   "
45869|NCT02456610|"~     Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality~     in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given~     either prophylactically or as early therapy for patients with detectable viral loads appear~     to be an effective strategy for reducing viral infections. However, long-term treatment with~     these drugs is associated with significant toxicity, expense and the appearance of drug~     resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T~     cells infusion to immunocompromised patients following HSCT is able to induce a successful~     anti-viral response. The primary purpose of this study is to determine the safety and~     efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with~     CMV and EBV reactivation or infection.~   "
45870|NCT02456597|"~     To investigate the function of a novel catheter for continuous peripheral nerve blocks in~     the popliteal nerve: Two key issues are investigated 1) Successful primary placement and~     function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in~     motor function following injection of local analgesics through the catheter; 2) The rate of~     displacement after standardized movement of the limb where the catheter for continuous~     peripheral nerve blocks is inserted.~   "
45871|NCT02456584|"~     This is a randomized, multi-center, parallel-group study to evaluate the pharmacodynamics~     (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150~     mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a~     confirmed ovulatory baseline cycle.~   "
45872|NCT02456571|"~     This pilot study will explore the prevalence of expression of four immune checkpoint~     biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that~     are captured by EpCAM via the CellSearch method, and specifically defined as co expressing~     DAPI and cytokeratin, and lacking CD45 expression.~   "
45873|NCT02456558|"~     This study will evaluate the safety, tolerability, antiretroviral activity,~     pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in~     HIV-infected subjects.~   "
45874|NCT02456545|"~     Prospective multicentre observational study for treatment approaches in at-risk individuals.~     Furthermore the purpose of this study is to test feasibility of a clinical staging model and~     validate diagnostic tools to identify individuals at risk state for the development of BD.~   "
45888|NCT02456363|"~     Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment~     of ankylosing spondylitis patient safety and efficacy.~   "
45876|NCT02456519|"~     Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services.~     Establishing whether this is being achieved requires validated measures of anaesthetic~     outcomes but few of these exist, particularly for children.~      QoR-15 (quality of recovery, 15 items) is a questionnaire that has been validated in adults~     and assesses the quality of postoperative recovery from surgery. The investigators have~     developed a modified version, the PaedQoR-15, that the investigators hope is capable of~     performing the same task in children and young people. The principle aim of this study is to~     assess whether PaedQoR-15 is a valid, reliable and clinically acceptable measure of the~     quality of postoperative recovery in children and young people.~      The investigators would also like to consider whether parent/guardian assessments of their~     child's recovery correlate with self-reports. At Great Ormond Street a significant~     proportion of children are unable to answer for themselves. If parent/guardian responses~     represent a good approximation then this questionnaire may have a role in assessing the~     quality of recovery in a population of children who are difficult to care for.~   "
45877|NCT02456506|"~     This study evaluates the hyperfractionated IMRT in the treatment of patients with locally~     recurrent nasopharyngeal carcinoma. Half of participants will receive hyperfractionated~     IMRT, while the other half will receive conventional fraction IMRT.~   "
45878|NCT02456493|"~     The patients who have undergone cardiac surgery have higher likelihood of postoperative~     cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with~     cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid~     IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative~     cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for~     OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by~     preoperative B-mode ultrasonography, and 50 patients who have coronary artery occlusive~     disease and do not undergone the operation are recruited as non-surgical group. The~     cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3~     months after operation. The patients in the non-surgical group are measured three times:~     baseline, after 7days, after 3 months.~   "
45879|NCT02456480|"~     To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients~     with mild to moderate atopic dermatitis (AD).~   "
45880|NCT02456467|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine~     blood draws in cardiac surgery patients.~   "
45881|NCT02456454|"~     Controlled trial of the efficacy and safety of valproate, versus risperidone in children,~     ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.~   "
45882|NCT02456441|"~     The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical~     syndrome characterized by urgency with or without urge incontinence , usually accompanied by~     frequency and nocturia , since in the absence of proven infection or other pathology related~     . The negative impact on quality of life of patients with OAB is already known. The etiology~     and pathophysiology of OAB are not completely understood. However, studies indicate an~     alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of~     OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as~     a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way .~     However, no studies in the literature evaluating the effect of electroconvulsive therapy on~     the mechanisms involved in sympathetic and parasympathetic modulation in these women . The~     objective of this study is to investigate the effects of TENS on the sympathetic and~     parasympathetic system in women with OAB . This is a randomized, double -blind , which will~     be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into~     2 groups : TENS group and placebo group. Interventions take place in one day assessment of~     the sympathetic and parasympathetic nervous system are performed . After collecting the data~     will be analyzed in accordance with the statistical analysis.~   "
45883|NCT02456428|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated~     with an increased risk of heart failure (HF) compared to other combinations of oral~     hypoglycemic agents (OHA).~      The investigators will carry out separate population based cohort studies using~     administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for HF. Analyses will be done~     separately for groups of patients with and without prior HF. The results from the separate~     sites will be combined to provide an overall assessment of the risk of HF in users of~     incretin-based drugs and by class of incretin-based drugs.~   "
45884|NCT02456415|"~     This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in~     patients with hand fractures who require internal fixation (to obtain a product license from~     the Ministry of Food and Drug Safety in Korea (MFDS)).~   "
45885|NCT02456402|"~     This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare~     Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery~     lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of~     bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or~     BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including~     arterial thrombosis at 1, 9 and 12 months.~   "
45886|NCT02456389|"~     The primary objective of this trial is to determine if perioperative risk stratification and~     risk-based, protocol-driven management leads to a reduction in the rate of death or serious~     complications compared to standard perioperative management in patients undergoing elective~     major cancer surgery.~   "
45887|NCT02456376|"~     The purpose of this study is to investigate how sensory information processing affects~     balance ability in children with cerebral palsy (CP). An additional goal is to determine if~     a subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can~     improve balance in children with CP. Children with CP and children with typical development~     will participate and complete a series of clinical and balance assessments. They will also~     be tested in a sensor fusion paradigm to investigate potential deficits in the dynamic~     integration of visual, vestibular and proprioceptive information during upright stance. SR~     stimulation will then be used to potentially improve these deficits and subsequently their~     balance ability.~   "
45889|NCT02456350|"~     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a~     safety switch will be infused back to patients with B cell malignancies, including lymphoma~     and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T~     cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment~     efficacy.~      Objectives:~      To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for~     patients with B cell malignancies.~      Eligibility:~      Patients between 1 and 85 years of age, who have relapsed or refractory CD19-expressing~     B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.~      Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria~     are eligible to participate.~      Patients must have adequate organ functions.~      Design:~        -  Peripheral blood from patients will be collected for isolation of peripheral blood~          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral~          vector encoding anti-CD19 CAR containing a CD28 and a CD3 zeta as costimulatory domains~          as well as a safety switch.~        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune~          system to accept modified T cells.~        -  Patients will receive an infusion of their own modified T cells. They will remain in~          the hospital to be monitored for adverse events until they have recovered from the~          treatment.~        -  Patients will have frequent follow-up visits to monitor the persistence of modified T~          cells and efficacy of the treatment.~   "
45890|NCT02456337|"~     The purpose of this study is to evaluate the reduction of gingival recession of single~     Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine~     collagen matrix graft and / or enamel matrix proteins.~   "
45891|NCT02456324|"~     The study is designed as a prospective, non-randomized clinical trial comparing safety and~     effectiveness of the CuraSeal PICS-AF device to historical data from commercially available~     devices for the treatment of anorectal fistulas.~   "
45892|NCT02456311|"~     VATS anatomical lung resection provides an effective minimally invasive treatment strategy~     for stage I and II lung cancer. VATS lobectomy is associated with significantly less~     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications~     when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~     Complications include: pulmonary vascular injuries (PA, pulmonary vein) necessitating urgent~     conversion to open thoracotomy and even death14. Causes of conversion included PA injury,~     difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler~     misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all~     tissue around PA branches is sometime difficult especially in the presence of adhesions or~     large, calcified lymph nodes and may increase the risk of vascular injury.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the~     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung~     resections were performed by VATS.~      The technical difficulty and danger of VATS lobectomy is directly related to PA branch~     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic~     surgeons regarding the adoption of VATS lobectomy. The investigators believe that by~     decreasing the manipulation and dissection required by the surgeon on the PA branches, these~     procedures will be safe and therefore more prevalent for anatomical pulmonary resections.~   "
45893|NCT02456298|"~     The main purpose of this study is to determine the most efficient way for families to reduce~     problem behavior in their children with an autism spectrum disorder. Parents will be trained~     using telehealth to use applied behavior analysis (ABA) procedures to improve child behavior~     and communication. The study compares an established type of ABA assessment and treatment to~     a briefer, more streamlined version of this same type of assessment/treatment.~   "
45894|NCT02456285|"~     Background When first diagnosed, colorectal cancer has already metastasized in about 20% of~     patients to the liver or further (termed synchronous disease). For patients with metastatic~     disease limited to the liver, major surgery to resect both the primary colorectal cancer and~     the liver metastasis provides 5-year survival rates of 25-40%.~      Conventional surgery removes the colorectal primary first, followed by adjuvant~     chemotherapy, and then resection of the liver metastasis. Surgical advances make synchronous~     resection (removing both primary and liver metastasis together) and liver-first resection~     possible.~      Currently, there is no conclusive evidence to show which approach improves morbidity or~     survival, and therefore there is no optimum clinical pathway. Treatment is decided at~     multidisciplinary team (MDT) meetings and is dependent on multiple factors: cancer staging,~     patient health and preferences, and clinical experience.~      Methods Colorectal cancer with Synchronous liver-limited hepatic Metastasis: an Inception~     Cohort (CoSMIC), will consent and recruit patients with a new diagnosis of synchronous~     colorectal cancer limited to the liver.~      Patients will be recruited at Manchester Royal Infirmary (a National Health Service (NHS)~     regional cancer-network approved Hepato-pancreato-biliary specialist centers over 2 years~     using standardized data collection. The sequence of treatment received by each patient, and~     factors influencing treatment decisions, will be recorded and evaluated against European~     Society of Medical Oncology guidelines. The effect of surgery on patient quality of life,~     morbidity, mortality and the long-term outcome will be measured and compared for different~     treatment sequences adjusted for prognostic factors.~      Anticipated Outputs and Value of Findings Direct comparison of conventional and new surgical~     sequences will be explored. Patient engagement, use of standardised recording, identifying~     common clinical patterns and decision making, and understanding sources of variation are~     essential steps to develop a definite randomized control trial to resolve the optimal~     clinical pathway.~   "
45895|NCT02456272|"~     This is a French pilot study in the Toulouse University Hospital that will include a minimum~     of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a~     hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.~   "
45921|NCT02455934|"~     Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or~     females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose~     tolerance with either one of the 5 study products~        1. Sucrose 50 g~        2. Sucrose 50 g + D-allulose (psicose) 2.5 g~        3. Sucrose 50 g + D-allulose (psicose) 5 g~        4. Sucrose 50 g + D-allulose (psicose) 7.5 g~        5. Sucrose 50 g + D-allulose (psicose) 10 g~      Primary endpoints:~        1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage~          on glucose tolerance~        2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage~          on insulin levels~   "
45922|NCT02455921|"~     The aim of this prospective randomized study is to investigate comparatively the effect of~     neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative~     cognitive function & behavior in children undergoing ENT surgery under general anaesthesia.~   "
45896|NCT02456259|"~     The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing~     each year. MICS procedures on atrioventricular valves are usually performed without~     conventional sternotomy, an alternative approach is from right anterolateral~     minithoracotomy. This surgical approach has essential impact both on anesthesia techniques~     and cardiopulmonary bypass (CPB) settings. Specific anesthesiological procedure is an~     insertion of neck venous cannula of CPB through the right internal jugular vein into the~     superior vena cava both for partial and total bypass. The size of neck cannula is between 15~     and 21 French depending on the type of surgical procedure and patient's weight. Central~     venous catheter and eventually sheath are also inserted into the right internal jugular~     vein. Thus, there is a relevant question regarding postoperative patency of right internal~     jugular vein in patients undergoing MICS procedures requiring an insertion of neck cannula~     of CPB. The investigators hypothesize, there is no significant difference in postoperative~     patency of internal jugular vein assessed by ultrasound in patient undergoing cardiac~     surgery with and without neck cannula of CPB~   "
45897|NCT02456246|"~     Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for~     early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease~     during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT)~     is the main technique to detect whether cancer has come back, but this method has~     demonstrated poor accuracy and reliability in determining if the observed post-operative~     lung changes are benign or malignant.~      Positron-emission tomography (PET) is an imaging technique that uses special radioactive~     tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA~     synthesis may be more accurate than CT for detecting if the cancer has come or not.~      The purpose of this study is to see if a PET radiotracer called 18F-FLT~     (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular~     CT scans.~   "
45898|NCT02456233|"~     This prospective randomized study will assess the safety and efficacy of FIRM-guided~     ablation (FIRM+PVI) compared to pulmonary vein isolation (PVI) without FIRM, for the~     treatment of symptomatic atrial fibrillation.~   "
45899|NCT02456220|"~     The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal~     changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG),~     in comparison with a Class II comparison group (CG). 3D virtual models generated from three~     time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months~     after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II~     malocclusion patients, in the same stage of biologic maturation and skeletal abnormality,~     but with no orthopedic treatment will be constructed for the CG subjects. These CG patients~     are under orthodontic treatment, but only with teeth alignment. Voxel based registration on~     the anterior cranial fossa will be used to assess maxillary and mandibular~     displacement/articular fossa remodeling; regional registration on the mandibular corpus will~     be performed to evaluate mandibular growth and mandibular dental changes; and regional~     registration on the anterior region of the maxilla will be performed to evaluate maxillary~     growth and maxillary dental changes.~   "
45900|NCT02456207|"~     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of~     SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma.~      The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of~     SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric~     antibodies (HACA).~   "
45901|NCT02456194|"~     This is a prospective clinical trial of tibial plateau fractures treated with internal~     fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into~     various bead sizes for implantation into bone defects. The graft material chosen for this~     study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void~     filler and may be mixed with a variety of antibiotics. The combination of STIMULAN +~     antibiotic in bead form is the study device.~      Our primary study aim is to look at resorption and remodeling of the study device into bone.~     Another important aim of the study is to look at subsidence, or collapse, of the joint~     surface.~   "
45902|NCT02456181|"~     The overall aim of the proposed project is to test the efficacy of a relatively new,~     well-developed math program on the math achievement of elementary school students in~     mainstream classes in urban schools. Use of this program is increasing in Canada and the~     United Kingdom. Preliminary findings derived from uncontrolled trials and our own pilot,~     randomized controlled trial suggest it may yield meaningful gains in math achievement for~     both at-risk and achieving students, as indexed by their performance on national exams, in~     national math competitions, as well as on standardized measures of math achievement.~     However, the program has yet to be rigorously evaluated to determine its relative efficacy~     compared to the math programs typically used by school boards. The program provision of~     grade-specific teacher's guides and student workbooks (for grades 1 to 8), and minimal~     teacher training, points to its potential utility for full-scale implementation, should its~     efficacy be confirmed.~   "
45903|NCT02456168|"~     Cognitive impairment occurs in as many as 80% of lupus patients and affective disorders,~     depression and anxiety, are also common. Both of these problems contribute significantly to~     disease burden and disability. Associations between serum anti-NMDAR Aab and cognitive and~     behavioral changes in human SLE have remained controversial, however, elevated titers of~     these Aabs in cerebrospinal fluid (CSF) correlate with severe central nervous system~     manifestations, such as coma and psychosis. The aim is to study the progression of disease~     (cognitive and behavioral impairment) over a 2 year period in SLE subjects with~     neuropsychologic and behavioral testing and correlates of disease progression using resting~     FDG-PET and serum Anti-NMDAR Aab. The correlations between hippocampal hypermetabolism,~     Anti-NMDAR Aab and memory impairment observed in the cross-sectional studies will be~     validated by baseline measurements in the proposed studies.~   "
45904|NCT02456155|"~     The investigators assessed the utility of ultrasonography in confirming the position of~     nasal jejunal tube after bedside placement when compared with endoscopic placement in~     patients with severe acute pancreatitis.~      Primary endpoint:~      Success rate.~      Secondary Endpoint:~      Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after~     placement), Tolerance of enteral nutrition, Time to approach the target calories.~   "
45905|NCT02456142|"~     Pain is a subjective sensation which in children can only be experienced and most times not~     expressed. Pain management in children thus falls short of their adult counterparts. Acute~     pain of surgery causes significant suffering and stress. In children, pain management has~     lagged behind because of the belief that children's pain receptors are less well developed~     than their adult counterparts. However this has been proven to be false as development of~     pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain~     bupivacaine has been used for effective post operative analgesia. Resources sometimes limit~     acquisition of additives to bupivacaine to be delivered into the intrathecal space.~      The fear of pharmacological adverse effects of opioids has restricted their use especially~     among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this~     has led to poor pain management in pediatric populations Mulago national referral hospital~     is a resource limited centre with regards to human resource, equipment and drugs. This is~     mainly due to lack of sufficient funds and large volume of patients with the nursing staff~     being overwhelmed by the patient capacity. Drug administration is often not done on time and~     continuous assessment of pain scores in children is not adequate resulting in poor post~     operative pain management. Pain control thus will depend on analgesia provided at the time~     of operation creating a need for prolonged pain control measures.~      Studies done have compared intravenous morphine administration versus caudal analgesia and~     are mostly focused of sub umbilical surgery however none has been done in our setting.~     Bupivacaine and morphine are now more readily available and can be used for post operative~     analgesia. However studies on the timing to the next analgesic requirement have not been~     compared/done in Mulago national referral hospital.~   "
45906|NCT02456129|"~     This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI)~     between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using~     intravenous microtracer dose of [14C]vilaprisan.~   "
45907|NCT02456116|"~     The purpose of this study is to evaluate the use of needle acupuncture in comparison to a~     conventional postoperative pain management in terms of reducing pain and pain medication use~     in an interdisciplinary setting in a controlled, randomized study design after implantation~     of total knee arthroplasty .~   "
45908|NCT02456103|"~     This is an open-label extension study for patients who complete a Phase 3,~     placebo-controlled study of ataluren in patients with nonsense mutation cystic fibrosis~     (nmCF) not receiving chronic inhaled aminoglycosides.~   "
45909|NCT02456090|"~     The purpose of the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles,~     Body Weight and Health Care is to use clinical data from electronic health records (EHR) and~     patient reported outcomes (PRO) to answer questions of clinical importance to patients,~     providers, and other stakeholders.~   "
45910|NCT02456077|"~     The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV)~     immunization program carried out in pediatric and family medicine practices would be more~     effective in improving adolescent patients' HPV immunization rates than the usual care~     provided to adolescents in pediatric and family medicine practices.~   "
45911|NCT02456064|"~     The purpose of this study is to determine whether a non-drug intensive program can help~     improve control of type 2 diabetes mellitus.~   "
45912|NCT02456051|"~     Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of~     patients at diagnosis is presented resectable because the diagnosis is often delayed making~     the 5-year survival of this disease globally less than 5%. An early diagnosis in these~     patients is currently not possible given the economic disadvantages of a population-wide~     screening. New evidences identify patients with new-onset diabetes as a subgroup of patients~     at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator~     secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes.~     Our goal is therefore to assess the different impact of Pancreatic Cancer depending on~     Adrenomedullin values in patients with newly diagnosed diabetes mellitus.~   "
45913|NCT02456038|"~     The aim of this study is to assess safety and efficacy of Asfotase Alfa (ALXN1215) in~     patients with hypophosphatasia~   "
45914|NCT02456025|"~     The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus~     0.01% eyedrops in patients with vernal keratoconjunctivitis.~   "
45915|NCT02456012|"~     The purpose of this study is to determine whether a long-term prophylactic use of~     esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the~     recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole~     therapy in high-risk patients whose Rockall score ≥ 6.~   "
45916|NCT02455999|"~     The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001~     eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome.~     General and local tolerability are also evaluated.~   "
45917|NCT02455986|"~     A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote~     physical activity (PA).~   "
45918|NCT02455973|"~     This study is a randomized clinical trial with two interventions: control group and~     intervention interdisciplinary group, without cross-over.~      Control Group (CG): In this type of intervention, the focus will be the development of~     skills through educational activities on health using the pedagogy of transmission.~      Interdisciplinary Intervention Group (IG): In this type of intervention, the focus will be~     the development of skills through educational activities on health that provide the~     development of autonomy and empowerment for behavior change, based on interdisciplinary~     motivational strategies. All topics will be focused on the major cardiovascular risk factors~     considered modifiable.~      The staff is trained to the techniques of motivational interviewing and transtheoretical~     model of change and the health issues related to the modification of lifestyle.~      So this interdisciplinary intervention with adolescents seeks to measure the result of an~     educational proposal using the techniques of motivational interviewing and transtheoretical~     model of change, for all professionals involved independent training in health issues~     related approach to lifestyle modification and the inclusion of family in this process.~   "
45919|NCT02455960|"~     This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in~     chronic kidney disease (CKD) patients.~   "
45920|NCT02455947|"~     The purpose of this study is to investigate the effect of Inquiry based stress reduction~     (IBSR) meditation technique on levels of burnout and wellbeing among teachers.~   "
45939|NCT02455700|"~     Prospective randomised crossover trial to assess if there is a difference in the level of~     pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the~     lower incisor region using either a motor driven reduction device or a hand held device~   "
45956|NCT02455479|"~     The purpose of this study is to assess the safety and preliminary efficacy of an~     anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of~     a vaccine to treat the neurological effects of cocaine by evoking immunity to prevent the~     effects of cocaine on the brain.~   "
45923|NCT02455908|"~     The aim of the study is to design an open-label phase 1-2 trial to assess safety and~     clinical and immunologic effects of repeated administration of recombinant low dose IL2~     (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs~     (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated~     for crioglobulinemic nephropathy:~      cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5~     consecutive days, starting from 3 weeks after the first cycle.~      cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first~     cycle.~      Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first~     cycle.~      Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during~     the first cycle and progressively reduced during the subsequent cycles.~      The first cycle will be performed during hospitalization in the investigators Unit;~     subsequent cycles will be performed at nephrology outpatients. All laboratory values~     normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome~     will be evaluated during the first week of treatment and at the end of the protocol,~     together with specific cellular values (Tregs, B cells, NK).~   "
45924|NCT02455895|"~     This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its~     Vehicle, on the ocular skin flora.~      In the pre-randomization phase, subjects will receive a single application of open-label~     NovaBay iLid Cleanser.~      In the randomization phase of Stages 1 and 2, subjects will self-treat with masked~     Investigational Product twice daily for ten (10) days.~   "
45925|NCT02455882|"~     Through the investigators' Breast Care Center at the University of Michigan Comprehensive~     Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant~     chemotherapy. The majority of the remainder of patients with stage II and III disease~     undergo treatment with adjuvant chemotherapy either on a clinical protocol or as standard of~     care. There is a subset of women with ER positive disease who do not receive chemotherapy~     because of favorable tumor characteristics.~      This tissue procurement protocol is designed to systematically collect tissue, urine and~     blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant~     chemotherapy, serially following treatment, and/or at the time of disease recurrence in~     order to investigate mechanisms underlying development of metastatic disease, to identify~     predictors of response and resistance to therapy, and to test potential new therapies for~     breast cancer using a combination of patient-derived xenograft creation and new microfluidic~     technologies.~   "
45926|NCT02455869|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical efficacy of two local drug delivery systems containing 1%~     ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic~     periodontitis as an adjunct to SRP.~   "
45927|NCT02455856|"~     The purpose of this study is to assess the effects of repeated once daily administration of~     200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ~     42847922 in healthy, male participants.~   "
45928|NCT02455843|"~     This study is a multicenter, randomized, open-label Phase III trial that compares microwave~     plus chemotherapy versus chemotherapy in patients with advanced non-small cell lung cancer.~     The primary endpoint is progression free survival (PFS) and the key secondary endpoint is~     overall survival (OS). A total of 400 eligible patients will be randomized to receive either~     microwave ablation combinated with first-line platinum-based doublet chemotherapy or~     first-line platinum-based doublet chemotherapy in a 1:1 ratio until patients. The response~     of microwave ablation will be assessed by the expert consensus for thermal ablation of~     primary and metastatic lung tumors. Tumor response and progression will be assessed~     according to Response Evaluation Criteria in Solid Tumors（RECIST）1.1.~   "
45929|NCT02455830|"~     This is a observational study to assess the effects of and to explore the mechanisms of~     autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring~     serum cytokines.~   "
45930|NCT02455817|"~     Single center, retrospective registry to collect data regarding the rate of angina (any and~     CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel~     revascularization rate within 12 months post stent implantation.~   "
45931|NCT02455804|"~     This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical~     study that will be conducted at up to 15 sites in the United States (US). All subjects will~     be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3~     years post-index stenting procedure. An unscheduled follow up may be conducted as clinically~     warranted.~   "
45932|NCT02455791|"~     The goal of this clinical research study is to compare the use of an ultrasound-guided~     biopsy with what is found during surgery in finding evidence of the disease.~   "
45933|NCT02455778|"~     This double blind placebo control study with supplementation of oral Cinnamon is being~     conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may~     lead to improvement in body composition and metabolic parameters.~   "
45934|NCT02455765|"~     The study will investigate if consumption of amino acid mixtures results a change in~     glycemic response of carbohydrate (white rice) and insulinemic response at different doses~     and timing (before consumption of carbohydrate).~   "
45935|NCT02455752|"~     The study involves the use of Retroperitoneal plane for TME for rectal anterior resection.~     Through a pilot prospective study, LR-TME will be assessed as one arm study.~   "
45936|NCT02455739|"~     The investigators aimed to assess whether postoperative gum chewing improve intestinal~     functions.~   "
45937|NCT02455726|"~     Magnesium exerts analgesic effects in several animal pain models and in patients affected by~     acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that~     magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).~      We describe the protocol of a single-center randomized double-blind clinical trial aimed at~     assessing the efficacy of oral magnesium supplementation in controlling severe pain in~     patients with advanced PAOD.~   "
45938|NCT02455713|"~     This study will examine the cardiopulmonary interactions that occur with increasing~     ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left~     heart syndrome before and after sternal closure. Outcome measures include oxygen delivery~     and cardiac output.~   "
45941|NCT02455674|"~     Weight calculation based on age could be performed according to APLS (Advanced Pediatric~     Life Support) guideline recommendations in children requiring emergency treatment and~     intervention in the field or during resuscitation with no active weight and height~     measurements. The aim of the study is to investigate the suitability of weight calculation~     using mean ages on clothing size labels (ACL) to the actual weight in real emergencies with~     no known actual age of the patient (AA).~   "
45942|NCT02455661|"~     FERARI is a single centre observational study comparing patients undergoing PCI either using~     radial compression devices or femoral closure devices at the corresponding access site.~      First primary outcomes consist of the occurrence of vascular complications at the arterial~     access site including major bleedings as defined by common classification systems~      Second primary outcomes consist of the occurrence of adverse cardiac events including~     all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days~     and 12 months of follow-up.~   "
45943|NCT02455648|"~     Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to~     result in varying degrees of stenosis, especially if the resected area is large and/or~     circumferential. A new technique was described where autologous cells from the patients own~     oral mucosa are harvested and cultures on proprietary membranes (coated, temperature~     sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.~   "
45944|NCT02455635|"~     Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic~     with saline distension medium. The presence or absence of lower abdominal pain and the side~     of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect~     the presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal~     chromopertubation was done.~   "
45945|NCT02455622|"~     This long-term study will provide Elaprase treatment to children enrolled in this study and~     will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient~     registry data to conduct the primary growth analysis to assess changes in height and weight~     in patients with Mucopolysaccharidosis II (Hunter syndrome) MPS II.~   "
45946|NCT02455609|"~     Currently, opioids are widely used for pain relief, but they often provide sub-optimal~     analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was~     introduced as a spinal anesthetic more than twenty years ago and found to have advantages~     over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in~     postoperative pain without severe sedation. The objectives of this study were to compare the~     efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their~     combination when added to bupivacaine for postoperative analgesia in major abdominal cancer~     surgery.~   "
45947|NCT02455596|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection in treating patients with advanced neuroendocrine~     tumors who have failed standard treatment or are unable to receive standard treatment.~   "
45948|NCT02455583|"~     The purpose of this study is to examine the effectiveness of an HIV prevention intervention~     called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce~     sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary~     schools (Form 1 - 3) in Eastern Botswana.~   "
45949|NCT02455570|"~     Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of~     various suspicious malignancies. The learning curve of EUS is regarded long but so far the~     literature of this topic is minimal. Few studies have been published and there are no~     standardized or validated methods to perform a systematic assessment of endosonographists in~     training. This study is an observational study dealing with the matter of assessing~     endosonographists in training.~   "
45950|NCT02455557|"~     This phase II trial studies the side effects and how well vaccine therapy works when given~     together with temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines~     made from the survivin peptide or antigen may help the body build an effective immune~     response to kill tumor cells that express survivin. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether temozolomide is more effective with or without vaccine therapy in treating~     glioblastoma.~   "
45951|NCT02455544|"~     The aim of the study is to validate in a prospective fashion the value of the Congo-Red Dot~     (CRD) test for diagnosis of preeclampsia. The working hypothesis is that in pregnancies~     complicated by preeclampsia, will display urine congophilia and have a positive CRD test.~   "
45952|NCT02455531|"~     The purpose of this study is to compare direct and indirect measures of right ventricular~     (RV) systolic and diastolic function between 11 year old subjects who had been randomly~     assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified~     Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.~   "
45953|NCT02455518|"~     The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of~     the comparative efficacy of 4 oral analgesics in the initial management of acute~     musculoskeletal extremity pain presenting to the ED.~   "
45954|NCT02455505|"~     The purpose of this study is to develop a screening tool to help identify family members who~     may need professional emotional support. The investigators are interested in enrolling~     family members of patients with advanced cancer care as well as family members who have lost~     a loved one to cancer. Some screening tools to identify family members who might need~     support do exist, but the investigators are hoping to develop one that is brief and easier~     for healthcare providers to use. The information learned in this study will help us refine~     the screening tool. The investigators are interviewing family members to identify which~     questions or items work well, which seem unclear, and to understand how a family member~     might approach completing the screening tool. Family member input will be essential in the~     development of this screening tool.~   "
45955|NCT02455492|"~     This epidemiological study investigates the association of recent stroke, acute coronary~     syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and~     cardiac surgery using routinely collected UK primary and secondary care patient data.~   "
45957|NCT02455466|"~     The purpose of this study is to investigate if clinically non explainable high or low~     Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the~     serum of participants. The investigators will examine if heterophilic antibodies are the~     reasons of altered PSA levels.~   "
45958|NCT02455453|"~     The purpose of this study is to evaluate the uptake of a radioactive tracer~     21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP)~     uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before~     and after administration of estradiol for one day (estrogen challenge) to determine if the~     change in uptake is a predictor of response to endocrine therapy (ET) in patients with~     hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor~     2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring~     estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat~     metastatic breast cancer. The investigators propose to study patients with biopsy-proven~     newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to~     be treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as~     standard of care therapy.~      Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one~     immediately following the one day estradiol challenge before the start of standard of care~     ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol~     orally (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour~     period.~   "
45959|NCT02455440|"~     Anesthesia techniques that minimize anesthetic requirements and their effects may be~     beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in~     blunting adrenergic response to several perioperative stimuli and so it might interfere in~     the effect of the anesthetic drugs on the brain. This study was designed to investigate the~     effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing~     craniotomy.~   "
45960|NCT02455427|"~     Stroke is the second cause of death worldwide and represented the first cause of death in~     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop~     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.~      This study addresses this important issue, by evaluating, in the early phase post-stroke,~     effects of motor conventional physical therapy associated or not with transcranial direct~     current stimulation (tDCS).~   "
45961|NCT02455414|"~     The goal of this study is to determine the pattern of early neurodegenerative changes in WFS~     (Wolfram Syndrome). The investigator will perform cross-sectional and longitudinal~     assessments of youth with WFS, targeting sensitive neural systems with quantified~     neuroimaging and behavioral measures. In addition, the investigator will establish the~     utility of a WFS severity rating scale (WFS Unified Rating Scale or WURS). Preliminary data~     support the feasibility of this approach and its potential to generate important new~     information about neurodevelopmental and neurodegenerative patterns in WFS. This work is~     necessary to position the field for future clinical trials to test interventions for WFS~     neurodegeneration. Ultimately, a better understanding of the trajectory of neurodegeneration~     in WFS and the development of effective interventions may be relevant to other more common~     neurodegenerative and endocrine (Type 1 and Type 2 diabetes) diseases in which ER stress has~     been implicated.~   "
45962|NCT02455401|"~     The purpose of this study is to compare the effect of remifentanil on postoperative vomiting~     in children undergoing strabismus surgery during sevoflurane anesthesia.~   "
45963|NCT02455388|"~     Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories~     consumed by youth. The role of AS in health is contentious, and the reliance on~     self-reported dietary data is an often-cited flaw in existing research. The investigators~     propose to establish the validity of the d13C biomarker for AS intake from fingerstick blood~     samples in children; our findings could significantly advance research addressing the health~     impacts of AS intake in children and adolescents.~   "
45964|NCT02455375|"~     Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial~     kits of which performances have not been established in real life, which use recombinant~     protein from strains from Central or North Europe. Molecular diagnostic of these infection~     is not the rule. Consequently the objectives of the project are to evaluate the performances~     of the serological commercial assays in real life in France and to assess the use of urine~     versus plasma for the molecular diagnostic of this infection.~   "
45965|NCT02455362|"~     Breathlessness, the sensation of breathing discomfort, is a major problem in people with~     chronic obstructive pulmonary disease (COPD). Breathlessness that persists despite optimal~     management of the underlying disease(s) is said to be refractory.~      Preliminary evidence suggests that a small, regular dose of morphine helps to reduce safely~     the sensation of breathlessness. However, this research on morphine for breathlessness has~     not defined the best way to adjust the dose of the medication, or refined which people are~     most likely to have benefit, no response or side effects.~      This is a randomized, double-blind phase III trial in people with COPD and significant~     refractory breathlessness, which will explore several important questions:~        -  Are regular, low dose opioids (morphine) at four possible doses over 3 weeks more~          effective than placebo medication (containing no active ingredient) at improving~          breathlessness?~        -  Does the medication have any effect on daily activity, breathlessness, and quality of~          life?~        -  What are the common side effects of this intervention?~        -  Does the benefit from the drug outweigh the side effects it produces?~        -  Are there specific characteristics of people who are more likely to receive benefit~          from sustained release morphine?~      Participants will be allocated to receive three weeks of morphine sulfate (and laxative,~     docusate with senna), or placebo (and placebo laxative). The dose of morphine may be~     increased each week for weeks two and three. All medicines will appear the same (blinded)~     and neither the doctor nor the participant will know which medication the participant is~     receiving.~      Participants will have a medical interview, physical examination to collect some general~     health information, and baseline measurements including; daily activity, symptoms, and~     quality of life. A small amount of blood may be required to check eligibility. Further blood~     samples may be taken at week 1 and 3 to enable testing on how individuals respond to~     opioids, further consent will be obtained for these samples. Data on benefits, side effects,~     and medical care will be collected during comprehensive weekly visits. Participants will~     also fill out a simple diary twice daily for weeks one to three of the study, and for one~     day each week during an optional 3 month extension stage.~      The outcome of this study may enable better management of symptoms and activity in people~     COPD with medicines that are shown to be effective and safe.~   "
45980|NCT02455167|"~     1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1,~          cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin~          (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).~        2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV)~          treatment using a new test of liver function, HepQuant-SHUNT.~   "
45981|NCT02455154|"~     To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in~     patients receiving adjuvant endocrine therapy.~   "
45966|NCT02455349|"~     The goal of this project is to evaluate an innovative psychosocial intervention package that~     will incorporate evidence-based treatment strategies to target the affective-motivational~     deficits, negative expectancies, and behavioral skills deficits that are central to the~     maintenance of negative symptoms. The intervention - called Engaging in Community Roles &~     Experiences (ENCoRE) - will include strategies aimed at teaching Veterans with schizophrenia~     and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase~     intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and~     (4) perform skillfully in new social situations, all of which can impact implementation of~     new skills and behaviors. Rather than develop a new set of intervention strategies, we will~     include within EnCoRE evidence-based strategies for these treatment domains. In addition,~     the investigators will collect qualitative information both from Veterans concerning their~     perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well~     as from a sample of mental health providers who work with Veterans with schizophrenia and~     negative symptoms, in order to inform a larger scale implementation trial should EnCoRE~     prove effective here.~   "
45967|NCT02455336|"~     Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs~     earlier in life, at a greater prevalence than that of the general population, and is the~     primary cause of death after the first year of injury. During the chronic phase of SCI, a~     characteristic dyslipidemia emerges, which is characterized by low serum high density~     lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an~     independent risk factor for coronary artery disease, and elevations in serum triglycerides~     (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually~     similar to those of the general population. The current proposal in persons with SCI aims to~     determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid~     medication whose primary action lowers serum TG and raises serum HDL-C levels.~   "
45968|NCT02455323|"~     The present study aims to assess the quality of life of patients suffering from tension-type~     headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study~     design involved a factorial, randomized, double-blind, controlled study~   "
45969|NCT02455310|"~     This study will perform a retrospective analysis to evaluate the effectiveness of a~     multicomponent educational intervention to improve medication use and management of~     behavioral and psychological symptoms of dementia, relative to a statewide intervention that~     has been ongoing. Medication use and symptom severity outcomes will be compared among~     intervention counties and demographically similar non-intervention counties.~   "
45970|NCT02455297|"~     The primary objective of this study is to assess objective response rate (ORR) in patients~     with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate~     ibrutinib.~   "
45971|NCT02455284|"~     White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia~     and to the brain stem and spinal cord. These tracts form the internal part of the brain and~     transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for~     numerous neurological diseases.~      Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging)~     technique providing information on white matter tracts (tractography) by studying water~     diffusion. Since it is based on complex mathematical models that only indirectly evaluates~     the underlying anatomy, tractography need to be validated before being used for research and~     clinical purposes. Several validation techniques were previously proposed, none of them~     being fully convincing in human.~   "
45972|NCT02455271|"~     To investigate the safety and efficacy of administration of eszopiclone for 6 months in~     insomnia participants.~   "
45973|NCT02455258|"~     The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy~     program adapted to older adults. Participants over 60 years old are enrolled in one of three~     groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12~     weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition,~     cognitive function, general health and lifestyle, and stress hormones are assessed at~     baseline, after 12 weeks and after 28 weeks.~   "
45974|NCT02455245|"~     This study is trying to learn and understand if the chemotherapy drug called carboplatin~     works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in~     children and young adults is using a combination of carboplatin and vincristine. Studies in~     children have shown that the use of carboplatin alone has promise of being just as effective~     for treating LGG as standard therapy. Additionally, this study will try to understand if~     treatment with carboplatin alone is associated with an improved quality of life for LGG~     patients and their families.~   "
45975|NCT02455232|"~     The aim of this study is to determinate what are the main muscles regularly involved in the~     spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow~     flexors. Three selective motor block nerves will be carry out in order to assess the gain of~     the range of motion (passive and active) of the elbow after each Motor Block Nerve.~   "
45976|NCT02455219|"~     A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or~     filter that enhances or improves photos. The prototype collimators are able to magnify~     target organs about four times compared to the current collimators. In this study we are~     validating a new collimator design, which will allow for quantitative measurement of~     dopamine receptors within the brain, not previously performed using a single photon gamma~     camera.~   "
45977|NCT02455206|"~     The purpose of this study is to investigate if a physical activity counseling program during~     pulmonary rehabilitation increases the physical activity level in daily life in patients~     with Chronic Obstructive Pulmonary Disease.~   "
45978|NCT02455193|"~     This study plans to learn more about how common drugs prescribed to individuals with~     schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite~     and the brain's response to food. In this study, the investigators will be evaluating how~     patients' brains respond to food images as well as asking questions about their food~     preferences and intake and clinical symptoms. The investigators may also ask patients to~     complete an exercise or diet intervention to see how this changes brain responses or food~     preferences.~   "
45979|NCT02455180|"~     The purpose of this study is to determine the pharmacokinetic properties of two different~     dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit~     with life-threatening illness.~   "
45983|NCT02455128|"~     This is a randomized clinical trial that aims to investigate the effect of therapeutic~     listening anxiety and preoperative fear of patients hospitalized for surgical treatment of~     colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and~     respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety~     Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be~     compared at two different times (before and after the intervention).~   "
45984|NCT02455115|"~     Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow,~     glomerular filtration rate and renal oxygen demand in patients with terminal liver failure~     directly after liver transplantation.~   "
45985|NCT02455102|"~     The aim of this randomized controlled study is to evaluate whether a newly designed~     electronic warning system will increase the initiation rate of adequate stroke preventive~     measures in patients with atrial fibrillation.~   "
45986|NCT02455089|"~     Given that GADD34 has been described as a potential key regulator of pro-inflammatory~     cytokine production in human and elevated blood marker in SLE patients, this study aim to~     prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic~     marker to assess the risk of SLE flare.~   "
45987|NCT02455076|"~     The purpose of this study is to try and achieve similar glycemic control in general~     non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in~     combination with basal insulin as compared to treatment with basal bolus insulin alone. The~     association between hyperglycemia and poor clinical outcomes in patients with diabetes is~     well established. Previous studies have shown that basal bolus insulin regimens improve~     glycemic control and reduce the rate of hospital complications compared to sliding scale~     regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The~     investigators will compare the efficacy and safety of exenatide alone or in combination with~     basal insulin to control high blood glucose levels resulting in a lower risk of~     hypoglycemia.~   "
45988|NCT02455050|"~     A study to evaluate the tolerability and acceptability of an investigational eye drop~     formulation in patients with Dry Eye Disease.~   "
45989|NCT02455037|"~     Evaluation of a neck strengthening program as a potential intervention to reduce the risk of~     sport-related concussion in youth contact and collision sport athletes.~   "
45990|NCT02455024|"~     This is an observational study to further characterize the safety profile of patients with~     chronic myeloid leukemia in the chronic phase (CP-CML) treated with Iclusig (ponatinib) in~     routine clinical practice in the US. The study is focused on analysis of vascular occlusive~     events.~   "
45991|NCT02455011|"~     This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate~     safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2~     diabetic subjects. The study will be conducted at multiple sites in the United States and~     will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve,~     controlled with diet and exercise or treated with oral antidiabetic medications.~   "
45992|NCT02454998|"~     Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip~     and palate patients. This procedure could obliterate oronasal fistula, stabilize dental~     arch, offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal~     fistula, we stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms~     of rhinorrhea or nasal obstruction could be improved. This dental arch defect could~     predispose further dental arch medial collapse. Without alveolar bone grafting the dental~     arch is not stable, dental movement during orthodontic treatment is limited and dental arch~     expansion is not possible.~      Previous to operation, the patient suffered from dental crowding and dental inclination~     toward to the cleft. This produces a difficult dental hygiene and predispose to dental~     caries and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By~     aligned the teeth previous to surgery, with a better dental hygiene, we purpose that the~     infection rate will be reduced and success rate will be better.~      The Purpose of this study is to determine whether pre-operative orthopedic treatment will~     affect secondary alveolar bone grafting outcome and to assess the nasal change after~     alveolar bone graft.~   "
45993|NCT02454972|"~     A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid~     Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall~     response rate (ORR), in the following advanced solid tumors small cell lung cancer (SCLC),~     head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma,~     endometrial carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and~     Ewing's family of tumors (EFTs)~   "
45994|NCT02454959|"~     This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days),~     Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to~     Severe COPD with and without a Valved Holding Chamber.~   "
45995|NCT02454946|"~     The researchers aimed to investigate the relationship between ABO blood types and erectile~     dysfunction.~   "
45996|NCT02454933|"~     A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of~     AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally~     Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small~     Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor Therapy~   "
45997|NCT02454920|"~     Study designed to determine the ability and accuracy of anterior segment optical coherence~     tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the~     insertion site of the extraocular muscles (EOM) in adults with and without previous~     strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT~     limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion~     measurement using calipers (gold standard).~   "
46022|NCT02454595|"~     This is a prospective open registry to measure the impact on first-line therapy of genomic~     testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage~     localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy~     tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness~     score will be shared with the physician and the patient.~   "
45998|NCT02454907|"~     Many patients with multiple sclerosis (MS) experience relapses of disease activity during~     which they have increased numbness, weakness, visual problems, or other symptoms. If a~     person with MS has new symptoms that are concerning to them, their doctor may want to see~     them in the office in order to confirm that these symptoms are due to a true relapse of~     activity before starting relapse treatment. This requirement can be frustrating for~     patients, who may have to take time off from work or travel long distances for such~     unexpected doctors' visits. In this study, the investigators will use input from patients~     with MS and MS physicians to create a relapse questionnaire that can be used to confirm a~     relapse has occurred. The investigators will also evaluate if having a more direct line of~     communication with the provider's office improves overall patient care and satisfaction.~   "
45999|NCT02454894|"~     The study is carried out in a prospective randomized controlled way. In the context of~     informed understanding from parents, compared with traditional process(no anesthesia; lying~     without the pillow and fasting water and food for four hours after lumbar puncture),~     randomly select lidocaine surface anesthesia and postoperative management (lying without the~     pillow for half an hour after lumbar puncture) . All children will be evaluated by the~     FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree~     of pain during and after lumbar puncture. Lumber puncture time, success rate and any~     postoperative condition will be recorded and analyzed.A questionaire about the operation for~     all parents and children will be investigated in order to establish an optimized lumbar~     puncture management process.~   "
46000|NCT02454881|"~     To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in~     intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for~     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.~   "
46001|NCT02454868|"~     Introduction: remifentanil's optimal dose for children intubation without neuromuscular~     blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for~     modeling remifentanil's dose-response curve for adequate intubation conditions as defined by~     previous studies.~   "
46002|NCT02454855|"~     Melatonin may represent an effective complementary treatment to standard chemotherapy in~     order to reduce asthenia, depression, sleep disturbances, cognitive impairment and~     performance status as part of quality of life. Moreover, melatonin has been evaluated in~     several clinical trials in cancer patients with no side effects . It could be particularly~     of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin~     production .~      The investigators propose to perform a prospective and randomized study to study the effect~     of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer~     patients (age ≥ 70) treated by chemotherapy.~   "
46003|NCT02454842|"~     This phase 2 study is designed to evaluate the safety and activity of TH-4000~     (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative,~     Advanced non-small cell lung cancer (NSCLC).~   "
46004|NCT02454829|"~     Evaluation of ovarian function by a questionnaire and by medical file analysis of women and~     girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997~     an 2013 in the investigators' institution in order to evaluate their residual ovarian~     function. A second part of the questionnaire concerns these women's satisfaction regarding~     the procedure.~   "
46005|NCT02454816|"~     Global and regional initiatives have been launched for the dual elimination of~     mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components~     in the initiatives, early detection and timely intervention of pregnant women infected with~     HIV and/or syphilis is critical. In order to improve the number of women tested and treated,~     innovative strategies are needed.~      Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types~     of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These~     generally require venous blood for screening of symptomatic and asymptomatic patients. In~     addition, these tests are technically demanding, and require laboratory equipment which is~     not widely available in most resource-limited settings.~      Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously~     detecting antibodies to HIV and syphilis (dual HIV & syphilis treponemalRDTs) using~     serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are~     now commercially available.~      In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in~     which one screening test with a second test to confirm initial positive results or two RDTs~     in parallel with a third test as a tiebreaker for discordant samples, can be used to~     diagnose HIV on finger-stick blood. To date, there are few data on the implications of using~     these RDTs in the antenatal clinic settings, although they have been evaluated in~     laboratory-based studies and shown encouraging sensitivities and specificities as compared~     with reference laboratory tests.~      The objective of this research is to assess the uptake of syphilis testing after the~     introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing~     in antenatal clinics in Colombia.~      The secondary objectives of the study are: To determine the uptake of treatment of syphilis~     after the intervention, To determine the uptake of HIV testing in ANC attendees after the~     intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and~     health workers, To assess the organizational and socio-cultural advantages and barriers to~     introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal~     services, To determine the workload and cost implications of introduction of dual~     HIV/syphilis RDTs in antenatal services~   "
46006|NCT02454803|"~     The primary purpose for this study is to understand the effect of botulinum toxin as a~     treatment integrated in the management of spasticity (stiffness) in the arm and/or hand,~     arising from any neurological condition. The study will look at the types of goals that~     people choose for treatment, and the extent to which these are achieved in different~     individuals.~   "
46007|NCT02454790|"~     Motive:~      In order to improve the treatment technique, a comprehensive follow-up program is needed to~     obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.~      Goal:~      To set-up and maintain a database containing treatment results in terms of tumor control,~     side effects, complications and patient-reported quality of life.~      A standard database of patients receiving photon treatment will be created. These data are~     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for~     both tumor control and toxicity after radio (chemo) therapy that can later be used for~     selecting patients for proton treatment.~   "
46008|NCT02454777|"~     This randomized pilot clinical trial studies the feasibility of high-intensity interval~     training in improving cardiovascular fitness in patients with stage I-III breast cancer~     undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may~     cause side effects to the heart. Aerobic exercise may help the heart function better, which~     may help protect it against side effects from trastuzumab. Exercise may also help reduce~     fatigue and prevent cancer from coming back. High-intensity interval training involves short~     bursts of higher intensity efforts with longer periods of recovery. This may also allow~     patients who cannot exercise for a long period of time to still be physically active. This~     trial studies whether patients can tolerate high-intensity interval training, and how well~     it works in improving fitness in patients with breast cancer receiving trastuzumab.~   "
46009|NCT02454764|"~     After fulfillment of the selection criteria, all the patients included in the trial will be~     administered Tenofovir that will be continued for 3 months and then stopped for 1 month,~     LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir~     and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2~     groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or~     Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT~     will be excluded. Patients will be closely monitored during the period of stopping tenofovir~     post pulse therapy and liver function tests will be performed weekly. Patients will be~     closely observed for the development of acute hepatitis or decompensation during the 4 -~     week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and~     HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done~     at 24 weeks post stoppage of treatment to look for sustained seroconversion and~     virological/biochemical response~   "
46010|NCT02454751|"~     Study Objective The primary object of this study is to investigate the safety and~     effectiveness of fentanyl on the management of incident dyspnea.~      Study Design The study design will be a cross over study with a minimum of a one hour wash~     out period.~   "
46011|NCT02454738|"~     To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for~     developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT~     scan.~   "
46012|NCT02454725|"~     Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce~     mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis,~     the US Centers for Disease Control and Prevention suggest that high risk groups get tested~     for HIV regularly, every three to six months. This study will examine the feasibility of a~     strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for~     HIV which, if successful, will help to identify Latino men unaware of their HIV status,~     benefitting them and the society.~   "
46013|NCT02454712|"~     PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable~     to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and~     pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.~   "
46014|NCT02454699|"~     This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study,~     subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg~     once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be~     assessed. Subjects must be 18 to 65 years of age, male or female; if female, be~     surgically-sterilized or post-menopausal; if male, have undergone vasectomy; have a body~     mass index (BMI) of 18 to 32 kg/m^2; not be a user of nicotine-containing products; be~     willing to abstain from nicotine-containing products, alcohol and illicit drugs during the~     study. Subjects will be followed for 28 days post dosing.~   "
46015|NCT02454686|"~     Most of the postoperative complications that may occur after hepatectomy are related to the~     underlying liver background, and the common preoperative tests do not completely predict~     such complications. Transient elastography by Fibroscan is used to calculate the stiffness~     and the steatosis of the liver, and it may be also used to predict postoperative~     complications after hepatectomy~   "
46016|NCT02454673|"~     The purpose of this study is to evaluate whether the R0 rate, pathological response degree,~     patterns of recurrence and long-term outcomes may be initially predicted in patients with~     locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant~     approach and salvage surgery.~   "
46017|NCT02454660|"~     Uncontrolled hypertension is a major cause of morbidity and mortality and many patients fail~     to take their antihypertensive medication as prescribed. The investigators propose to use~     artificial intelligence (AI) to allow short message service (SMS or text messages)~     interventions to adapt to patients' adherence needs and substantially improve medication~     taking. The aims of the study are to: (1) develop AI methods for adaptive decision-making in~     human-centered environments and demonstrate the feasibility of the resulting AI-enhanced SMS~     medication adherence intervention, (2) demonstrate that the intervention can learn by~     adapting the SMS message stream according to patients' medication taking over time, and (3)~     examine potential intervention impact as measured by improvements in medication adherence~     and systolic blood pressures. The investigators will recruit 100 patients with uncontrolled~     hypertension and antihypertensive medication non-adherence. Adherence and other covariates~     will be measured via surveys at baseline, 3- and 6 months; blood pressures will be measured~     at baseline and 6 months. Participants will be given an electronic pill-bottle adherence~     monitor. Participants will receive SMS messages designed to motivate antihypertensive~     medication adherence. Message content and frequency will adapt automatically using AI~     algorithms designed to automatically optimize expected pill bottle opening. For Aim 1, the~     first 25 patients will be enrolled to develop and test alternative RL algorithms and~     fine-tune the system parameters. For Aim 2, the investigators will examine changes in the~     probability distribution over message-types and compare that distribution with patients'~     reasons for non-adherence reported at baseline. For Aim 3, the investigators will examine~     changes in self-reported medication non-adherence and blood pressure and~     automatically-reported pill bottle openings. This pilot study will establish the feasibility~     and potential impact of this novel approach to mobile health messaging for self-management~     support. The results will be used to support an R01 application for a larger and more~     definitive trial of intervention impacts.~   "
46018|NCT02454647|"~     The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with~     locally advanced gastric cancer and the identification of prognostic factors.~   "
46019|NCT02454634|"~     The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1)~     peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to~     glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and~     tolerability of and immune response to the IDH1 peptide vaccine in patients with~     IDH1R132H-mutated, WHO grade III-IV gliomas.~   "
46020|NCT02454621|"~     The study will recruit patients who smoke from a general practice clinic and randomize them~     either to: (1) form implementation intentions by linking in memory situations in which they~     are tempted to smoke with strategies to avoid smoking in those situations using a volitional~     help sheet, or (2) to consider the situations in which they are tempted to smoke alongside~     possible strategies to avoid smoking as presented in the volitional help sheet but not to~     form implementation intentions. The effects on self-reported smoking will be assessed 1~     month post-intervention.~   "
46021|NCT02454608|"~     Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce~     inflammation in a variety of tissues. Verapamil has also been shown to improve eosinophilic~     inflammation in an animal model of asthma and also functions as a P-glycoprotein(P-gp)~     inhibitor. A major subtype of chronic rhinosinusitis(CRS) is characterized by eosinophilic~     inflammation as well as P-gp overexpression. The goal of this study is to therefore see~     whether Verapamil may be used to treat CRS.~   "
46023|NCT02454582|"~     SUMMARY AND AIM~      Background:~      The proper management of brain oxygenation is an essential component of all anaesthesiologic~     procedures. Nevertheless, the brain remains one of the least monitored organs in the~     perioperative phase and intensive care therapy.~      The INVOS Brain Oxymeter (IBO) is a reliable trend monitor for changes in regional cerebral~     oxygenation (rSO2).~      It is a current assumption that rSO2 directly correlates with Sa02, which can be influenced~     by different ventilation assistance systems, e.g. CPAP therapy.~      Objectives:~      The project aims at investigating changes of rSO2 in patients undergoing CPAP therapy for~     max. 15 minutes, in order to evaluate the effect of CPAP on cerebral oxygenation.~      Methods:~      NIRS measurement (with IBO) will be performed on the temporoparietal cortex on both sides of~     the head. The trial will consist of two parts i.e. with or without ventilatory assistance.~     The order of starting the study with or without CPAP therapy will be randomized. During each~     part the measurements will be performed until reaching a steady state (no change in rSO2 ±~     2% for 3 min) but with a maximum duration of 15min. After each interval a BGA (blood gas~     analysis) will be performed.~   "
46024|NCT02454569|"~     The VFHCS is a long-term prospective cohort study of HIV infected patients from a~     resource-poor rural setting in India. The aim of the study is to use data collected from~     routine clinical care in order to describe the epidemiology of HIV and its related~     conditions in the investigators area, and to study the effectiveness of health interventions~     in a real-world setting (implementation and operational research).~   "
46025|NCT02454556|"~     This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental~     study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the~     original one (Gonal-f ®).~   "
46026|NCT02454543|"~     The aim of the study is to investigate, the effect of radical prostatectomy with extended~     lymphadenectomy on cancer-specific survival, time to castration-resistance, time to~     progression and quality of life in patients with a limited bone metastatic prostate cancer.~     In addition the influence of patient- and disease-related factors on clinical outcome~     (prognostic effect) and on the comparison therapy (predictive effect) will be examined.~   "
46027|NCT02454530|"~     The aim of this study is to describe in real-life conditions the determinants of use of GCSF~     (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in~     patients receiving chemotherapy for solid tumour according to the chemotherapy context:~     adjuvant or metastatic setting.~   "
46028|NCT02454517|"~     This randomized phase III trial studies a diet and exercise program based on the Diabetes~     Prevention Program to promote weight loss and improve health in men with low-risk or~     low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that~     promotes weight loss may influence prostate health. A combined diet and exercise program~     that is based on the Diabetes Prevention Program may affect markers (or biomarkers) of~     prostate cancer progression. Gathering this information may help doctors understand how~     obesity affects prostate cancer progression and may help lead to a program that can reduce~     the risk of prostate cancer progression.~   "
46029|NCT02454504|"~     With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted~     using continuous intravenous infusion of curare, which ensures maximum neuromuscular~     relaxation until the end of the intervention. Sugammadex, administered for the reversal of~     deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a~     positive effect also on the recovery of cognitive function, psychomotor coordination and~     mental ability, effects undocumented in Literature.~      The aim of the investigators study was to assess whether the reversal with sugammadex after~     intraoperative continuous infusion of rocuronium, can improve the quality of awakening.~   "
46030|NCT02454491|"~     Transradial approach (TRA) for cardiac catheterization and percutaneous coronary~     interventions (PCI) is increasingly being used worldwide. At the present is unknown the~     cocktail of agents necessary to minimize local access site complications. The investigators~     planned a prospective randomized clinical trial to test the superiority of verapamil vs.~     heparin in the reduction of access site related complications.~   "
46031|NCT02454478|"~     Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with~     Everolimus in participants with unresectable advanced or metastatic RCC.~   "
46032|NCT02454465|"~     With an increase of over 38% in neurological related hospital admissions between 2008-13,~     there are now over 12.5 million cases of individuals with neurological conditions in the UK.~     Following diagnosis of a neurological condition, there is often a period of adjustment to~     new life circumstances, with changes to relationships, ability to work and leisure~     activities. With a future often fraught with uncertainty, psychological difficulties such as~     Anxiety and Depression are common. It is estimated that following diagnosis of a~     neurological condition, up to 60% of individual's will experience mental health~     difficulties.~      Acceptance and Commitment Therapy (ACT) has been gaining popularity in supporting those with~     neurological conditions. ACT is based on emotional acceptance and supporting individuals to~     live a valued life, despite ongoing symptoms. Research into the use of ACT with this~     population has found it to be effective in reducing levels of psychological distress and~     increasing psychological flexibility.~      With limited resources and an ever increasing desire to improve interventions offered to~     patients, services are now looking at new and innovative ways of offering increasingly~     effective and satisfactory treatments. Therefore, in early 2014, the author devised a six~     week ACT group intervention for adjustment following diagnosis of a neurological condition.~     The intervention provides a combination of ACT techniques, in addition to a space for group~     members to build relationships and share their difficulties, to help individuals increase~     acceptance of their difficulties and reduce psychological distress.~      Following an initial pilot, findings illustrated that participants' psychological distress~     reduced and psychological flexibility increased. Therefore, this research project aims to~     further evaluate the intervention under controlled conditions.~   "
46033|NCT02454452|"~     Randomized controlled clinical trial aimed to compare the effectiveness and safety of~     radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous~     insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of~     saphenous vein reflux, patient quality of life and post-surgical complications.~   "
46044|NCT02454309|"~     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract~     infections (UTIs) in women. Approximately 150 adult women will be recruited to participate~     in this study. Subjects will be randomized to either the cranberry supplement or placebo~     treatment for 12 months. Subjects and investigators will be blinded to which supplement they~     are taking.~   "
46045|NCT02454296|"~     To assess if paracervical block is effective at reducing discomfort during placement of~     intracervical laminaria for pre-operative cervical preparation.~   "
46034|NCT02454439|"~     The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF~     patients with NICD and reduced ejection fraction on 12-month HF status.~      In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with~     reduced ejection fraction patients with non specific intraventricular conduction delay~     (NICD) has never been confirmed even if it is recommended.~      At the moment, no dedicated study has already been performed to assess the benefit of CRT in~     patients with NICD. Results from CRT therapy are contradictory in this patient group and~     have only been obtained from subgroup analysis. Some of them don't show clinical benefit but~     others show a benefit in term of an end-diastolic and/or end-systolic left ventricular~     volume (decrease of the size and the volumes of left ventricule).~      The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration~     (≥120 ms) for the indication of CRT implantation, without any consideration for the type of~     conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines,~     consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in~     addition to QRS duration (>150 ms). Indications for resynchronization have been restricted~     since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only~     in NYHA III and ambulatory IV; level of evidence A). The same modifications have been~     applied between 2011 and 2013 in the European guidelines. None is known about patients with~     NICD and QRS > 130 ms.~   "
46035|NCT02454426|"~     This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety,~     and tolerability of vortioxetine for the treatment of major depressive disorder in patients~     with coronary artery disease. In addition, the study will assess the effects of vortioxetine~     on heart rate variability in these patients.~   "
46036|NCT02454413|"~     Clinical guidelines for denture care are available, but evidence for optimal nocturnal~     storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore~     performed a study (submitted for publication) to evaluate the effect of different overnight~     storage protocols on denture biofilm formation and maturation. The results of this study~     showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline~     Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage~     reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no~     mechanical denture cleaning was performed in the aforementioned study, the aim of the~     proposed study is to evaluate the combined effect of mechanical cleaning and overnight~     storage condition on the microbial composition and Candida albicans colonization of denture~     biofilm formation. This information is required to develop a clinical guideline on acrylic~     denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic~     microorganisms, particularly in bedridden and immunocompromised patients.~      It is hypothetised that mechanical denture cleaning will decrease the impact of overnight~     denture storage condition on biofilm formation on acrylic removable dentures.~   "
46037|NCT02454400|"~     The aim is to study if pre-surgery physiotherapy improves function, pain and health in~     patients with specific low back pain scheduled for surgery. Patients are followed over a two~     year period. A secondary aim is to study what factors predict short and long term outcomes.~   "
46038|NCT02454387|"~     A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of~     ONO-4474 in healthy volunteers.~   "
46039|NCT02454374|"~     This study is a randomised controlled clinical trial designed to evaluate the effectiveness~     of two different exercise based treatments in the management of patients with knee problems~     related to degenerative (wear and tear) changes.~      Recent evidence suggests that putting weight through a joint (joint loading) may be~     beneficial.~      The Investigators know that physiotherapy and exercise is important in treating these~     patients, but the investigators do not know which exercises work best. In this study the~     investigators will be comparing current physiotherapy care against a new programme of~     exercises that gradually increases the amount of joint loading.~      The study will recruit approximately 140 patients from the Leeds Musculoskeletal (MSK)~     service, who are over the age of 45 and have been referred for physiotherapy by their GP for~     activity related knee pain.Patients who are suitable and happy to take part will be selected~     randomly (not chosen by the patient or physiotherapist) to receive either normal~     physiotherapy treatment, or the knee loading exercises. The treatment phase will last for~     six weeks and participants will be asked to carry out their exercises twice daily during~     this time. At the end of this period, patients will be asked tocomplete questionnaires and~     again at six months so that the investigators can assess how the patients are doing.~      The main aim is to evaluate clinical effectiveness of the progressive joint loading~     protocol. However, the data collected will also be used to see if there is a way of~     identifying in advance those who might respond better to either treatment.~      The investigators will also collect some information relating to the cost effectiveness of~     delivering different treatments. The final aim of this study is to test how easy it is to~     collect more detailed data in this area if a related study were to be carried out in the~     future.~   "
46040|NCT02454361|"~     This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate~     the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral~     single ascending dose administration and with an open label food effect panel.~   "
46041|NCT02454348|"~     Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress~     to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ~     system, and further develop into septic shock if the patient cannot regain adequate systemic~     blood pressure and perfusion after adequate and appropriate fluid resuscitation. Further~     prospective study of the potential mortality benefit with combination norepinephrine and~     vasopressin in critically ill patients with septic shock needs to be performed. Our research~     will resolve this essential question and improve the scientific knowledge surrounding~     vasoactive medications in patients with septic shock.~   "
46042|NCT02454335|"~     Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal~     achalasia, performed by GI endoscopist without cutting any surface of the human body. The~     main constituent of the procedure is the myotomy part, through which the endoscopist cuts~     the muscle fibers in the submucosa. Since this procedure is completely new to the area of~     treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better~     in relieving the symptoms. Thenceforth, this study aims at randomizing patients with~     achalasia presenting for POEM to getting either the posterior or the anterior myotomy.~     Patients will be followed up for symptoms and complications; data will be extracted and the~     appropriate analysis will be employed to determine if there is any difference of outcome~     between the two techniques of myotomy.~   "
46043|NCT02454322|"~     Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of~     pregnancy. The primary aim of this study is to determine if women who receive magnesium are~     less likely to experience postpartum depression. Other aims include examining the~     relationship between receiving magnesium and cognitive function and birth experience.~   "
46046|NCT02454283|"~     LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled~     study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the~     conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to~     normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400~     vanoxerine and 200 placebo subjects receive study drug.~   "
46047|NCT02454270|"~     The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities~     (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose~     (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously~     to participants with relapsed or refractory B-cell malignancies [diffuse-large B cell~     lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic~     leukemia (CLL), and acute lymphoblastic leukemia (ALL)].~   "
46048|NCT02454257|"~     The aim of the proposed study is to better understand the epidemiology of, risk factors for~     and consequences of critical illness leading to improvements in the risk models used to~     underpin national clinical audits for adult general critical care, cardiothoracic critical~     care and in-hospital cardiac arrest using data linkage with other routinely collected data~     sources.~   "
46049|NCT02454244|"~     Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic~     Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT)~     are scarce. The investigators have added mindfulness to this therapy, based on preliminary~     reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with~     Mindfulness (ART+MF).~      Other therapy that has been assessed in many psychiatric and medical disorders during the~     last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.~      Aims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general~     function of the patients with FM. A secondary objective is to assess the effect of these~     therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some~     biomarkers related with inflammation).~      Methods:~        -  Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c)~          Relaxation as control intervention.~        -  Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from~          primary care settings at the city of Zaragoza, Spain.~   "
46050|NCT02454231|"~     The investigators designed a randomized clinical trial (stem cell emergency life threatening~     arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of~     enriched circulating EPCs (ECEPCs) with auto-transplant of BM-MNCs. ECEPCs, obtained by~     immunoselection of CD14+ and CD34+ cells, or BM-MNCs, were injected intramuscularly in the~     affected limb of patients with critical limb ischemia (CLI).~   "
46051|NCT02454218|"~     tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study~     deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of~     40 patients, divided into two groups with sham interventions and active crossover.~   "
46052|NCT02454205|"~     This study aims to evaluate the impact of a new injection-free six-to-nine month treatment~     regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high~     dose isoniazid (INH) compared to the conventional empiric injection-based regimen of 21-24~     months treatment. The secondary aim is to determine if other treatment-related outcomes~     including adverse events, adherence to treatment, culture conversion, and cure/completion~     are significantly different in the intervention and conventional arms.~   "
46053|NCT02454192|"~     The purpose of this study is to systematically investigate across health center study sites~     participating in this study the process of adopting, integrating, implementing, and~     diffusing a minimum set of evidence-based interventions for the management of childhood~     asthma. Investigators hypothesized that an intervention that is evidence- and~     consensus-based (i.e., minimum elements to be integrated into existing practice, dosing of~     each element) would be implemented effectively, as measured by health center performance~     improvement on child health outcomes, health care utilization, and other measures (e.g.,~     avoidable costs).~   "
46054|NCT02454179|"~     Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with~     advanced head and neck squamous cell carcinoma.~   "
46055|NCT02454166|"~     Background and objective: Stroke, which means sudden onset of cerebral vascular accident.~     The earliest document was found in Neijing. The ancient physicians had different opinions~     and points of view on the etiology and pathogenesis of stroke. Before the Tang and Song~     dynasty, the exopathic wind theory was talked about. And, after then, the endogenous~     wind theory was put forward. While in the Ming dynasty, Zhang Jing-Yue advocated that~     Stroke is not caused by wind etiology'', highlighting the much difference of the thinking.~     Until nowadays, many famous physicians have their own unique way to determine the etiologic~     factor based on differentiation. To be practical, objectivity differentiating and~     determining the etiologic factor of stroke is the foundation of establishing the treatment~     guidelines. The investigators aim to establish the scientific epidemiological standard of~     traditional Chinese Medicine (TCM) syndromes of acute ischemic stroke in Taiwan.~   "
46056|NCT02454153|"~     This is a randomized control trial in people with diabetes and obstructive sleep apnea who~     will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep~     education or healthy lifestyle and sleep education.~   "
46057|NCT02454140|"~     This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic~     radiotherapy (SBRT) in pancreatic cancer.~   "
46058|NCT02454127|"~     A single-center randomized trial at an academic medical center in Boston, Mass, of~     overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia.~     Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups~     until January 24, 2002.~   "
46059|NCT02454114|"~     HOME FIRST (Home Followed - up with Infection Respiratory Support Team) is an early~     supported discharge scheme. It will enable patients with lower respiratory tract infection~     (LRTI) to be provided with high quality safe, effective, efficient patient centred care,~     tailored to their needs in their own home; aiming to improve the overall experience of the~     service user, improve patient outcomes and reduce hospital length of stay whilst~     simultaneously reducing admission rates, an area of major strategic importance to the NHS.~   "
46060|NCT02454101|"~     To compare the short term risks and benefits of cord milking 5 times toward the neonate with~     delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean~     section.~   "
46064|NCT02454049|"~     The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances~     time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo~     supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance~     will be investigated in spinal cord injured and non-injured athletes.~   "
46065|NCT02454036|"~     Baseline self-report outcome measures will be completed and additional assessments will~     occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6~     months following completion of all sessions. Patients and therapists will complete the~     evaluation measures in private (at home, in an office).~      At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and~     individual formats. The course of individual treatment varies and group treatment consists~     of 10 1.5-hour weekly sessions in the intensive phase, followed by 2 1.5-hour bi-weekly~     maintenance sessions. Individual treatment is one-on-one. In group treatment, there are~     typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to~     learn adaptive coping strategies and how to apply them to daily stressors. Additional~     content discusses use of seeking information, enhancing social support, enhancing body~     esteem and intimacy, and maintaining positive changes.~   "
46066|NCT02454023|"~     Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated~     with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite~     its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this~     study is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after~     stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an~     increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in~     sleep-related and functional outcomes.~   "
46067|NCT02454010|"~     The purpose of this study is to determine the safety and tolerability in subjects who~     receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid~     tumors.~   "
46068|NCT02453997|"~     This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their~     impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients~     (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10,~     12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months'~     intervals and also when clinically significant events occurred. The MPA levels will be~     correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be~     carried out and correlated with MPA exposure and clinical outcomes.~   "
46069|NCT02453984|"~     By performing a 89Zr-MPDL3280A-PET scan prior to treatment with MPDL3280A, the uptake of the~     tracer in the primary and metastatic tumor lesions and normal organ distribution can be~     evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient~     selection in the future.~   "
46070|NCT02453971|"~     The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D)~     in students. Compared to the control group subjects who conducted eCHUG-D should have less~     alcohol consumption and less alcohol associated problems after three and six months.~   "
46071|NCT02453958|"~     Evaluation of the utility of a multi-modal assessment tool in distinguishing between~     individuals with and without a history of mild traumatic brain injury.~   "
46072|NCT02453945|"~     The primary purpose of this study is to examine whether a properly fitted support bra on~     females improves their quality of life post-sternotomy. Specifically, does a support bra~     reduce discomfort, pain and wound dehiscence.~   "
46073|NCT02453932|"~     This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to~     moderate vascular dementia in a more reasonable design.~   "
46074|NCT02453919|"~     The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a~     single hospital registry of adults living with HIV, with one or more other cardiovascular~     risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine~     Hospital. RECOVIH is an observational and prospective, monocentric (institutional) registry,~     with anonymized cardiac, biochemical and associated data collection.~   "
46075|NCT02453906|"~     The investigators will use EEG, structural MRI, and resting-state functional connectivity~     MRI to assess neuronal responses in 28 healthy subjects to different somatosensory~     stimulations.~   "
46076|NCT02453893|"~     This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical~     study. Chinese subjects with Ischemic Schizophrenia.~   "
46077|NCT02453880|"~     Symptoms of anxiety and depression are common in adolescents and young adults with chronic~     illnesses and are associated with decreased adherence to medical regimens. However, many~     young patients go untreated for anxiety and depression. The purpose of this study is to~     evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic~     illness. Prior research has shown online CBT to be effective in multiple other populations,~     but to the investigators' knowledge, this is the first study to examine web-based CBT for~     young adults with chronic illnesses.~   "
46078|NCT02453867|"~     Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with~     tacrolimus once daily for senior (>65 years of age) renal transplant recipients~   "
46079|NCT02453854|"~     A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in~     the 'Small Changes' programme.~   "
46080|NCT02453841|"~     This proposed study will assess the hemodynamic effects and measure the systemic absorption~     of topically applied oxymetazoline in patients undergoing functional endoscopic sinus~     surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline~     as standard of care during the surgery.~   "
46091|NCT02453698|"~     The aim of this study is to investigate the effects of Methylphenidate on neural activity~     underlying inhibitory control and error monitoring in healthy adults. More specifically, the~     investigators aim to establish the baseline modulatory effect of Mehtlylphenidate on~     bottom-up and top-down aspects of these cognitive processes. This work will further our~     understanding of Attention Deficit Hyperactivity Disorder, Methylphenidate, and executive~     functioning.~   "
46092|NCT02453685|"~     This trial is conducted globally. The aim of this trial is to compare stepwise insulin~     intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin~     glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately~     controlled on oral anti-diabetic therapy.~   "
46081|NCT02453828|"~     Perioperative management decisions must often be made quickly and rely on practitioners~     having relevant facts at hand. During transitions of patient care between anesthesia~     providers, known as handovers, information may not be completely or faithfully~     communicated, consequently impairing the provider's ability to intervene correctly in~     response to subsequent events. Checklists have consistently proven to be effective at~     enhancing communications during handovers, but whether anesthesia checklists improve patient~     outcomes has yet to be proven. The investigators propose to randomize intraoperative~     anesthesia provider handovers to standard practice (no specific format) or to a handover~     checklist presented by a decision-support system in conjunction with the investigators~     electronic record. Specifically, the investigators will test the hypothesis that~     incorporating a largely pre-populated handover checklist into transitions of intraoperative~     anesthesia care decreases a composite of mortality and serious cardiovascular, respiratory,~     gastrointestinal, urinary, and infectious complications.~   "
46082|NCT02453815|"~     Even slight reduction in serious complications related to blood pressure management would~     easily justify the cost and relatively rare complications consequent to arterial catheter~     insertion. However, it seems unlikely that major outcomes will be improved by the presumably~     slight difference in hemodynamic control resulting continuous blood pressure measurement~     rather than measurements at 2-5-minute intervals. There is considerable variation in~     practice and no clear consensus whether arterial lines should be placed or not, especially~     in ASA 2 patients undergoing major non-cardiac surgery or ASA-3 patients undergoing moderate~     to major non-cardiac surgery. Clearly, if there is no benefit to outcome, arterial lines,~     which are invasive and costly, should not be placed routinely. The investigators therefore~     propose to test the primary hypothesis that use of arterial catheters decreases the risk of~     a collapsed composite of in-hospital mortality, re-admissions, MINS, AKI, stroke,~     respiratory and wound healing and gastro-intestinal complications after non-cardiac surgery.~      Secondarily, the investigators propose to test the hypotheses that arterial catheter use: 1)~     decreases the duration of hospitalization; 2) increases blood gas, electrolyte, and~     coagulation testing; 3) increases induction-to-incision time; and, 4) increases cost-of-care~     (supplies,, blood tests, and induction-to-incision time).~   "
46083|NCT02453802|"~     The purpose of the study, therefore, is to conduct a prospective randomized controlled trial~     to investigate the blood-conservation effect of TXA in different TKA patients groups with~     rivaroxaban for VTE prophylaxis, first group by topical application, second group by~     infusion and a third group of placebo and observe whether there is difference in the~     occurrence of venous thromboembolism in those patient groups by venographic study~   "
46084|NCT02453789|"~     The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry~     powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.~   "
46085|NCT02453776|"~     Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with~     inflammatory bowel disease (IBD). However, a large proportion of patients will eventually~     lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment~     with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order~     to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve~     the outcome of IFX treatment.~   "
46086|NCT02453763|"~     The purpose of this research study is to measure current flow inside the head using magnetic~     resonance imaging (MRI). The data from this study will be used to map the current flow~     caused from the electrical stimulation inside the head. The methods develop will be used to~     map and better control delivery of the current for electrical stimulation to modify a~     psychiatric condition such as depression; or other conditions such as epilepsy, Parkinson's~     disease or autism.~   "
46087|NCT02453750|"~     We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway~     inflammation as a first step to characterize the reported bronchodilator responsiveness.~     Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to~     document the amount and type of inflammation present. Another ancillary non-invasive measure~     of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective~     of this study is to determine if CDH patients have any evidence of airway inflammation. The~     hypothesis of this study is that children with CDH do not have evidence of airway~     inflammation associated with bronchodilator responsiveness. Based on this information,~     treatment for CDH patients will hopefully be more accurate and appropriate for their~     specific needs.~   "
46088|NCT02453737|"~     This is an open label phase II study to determine the safety and efficacy of a novel 3~     fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early~     invasive and noninvasive breast cancer. The three techniques utilized are recognized as~     standard options for the delivery of APBI, and there is no evidence that either technique is~     superior or inferior to any other. The APBI technique utilized will be at the physician's~     discretion and will be based on technical considerations, availability at the treating~     radiation facility, insurance coverage, as well as patient preference.~   "
46089|NCT02453724|"~     The purpose of this study is to investigate if diagnostic ultrasound as it is routinely~     performed in humans causes lung hemorrhage significant enough to appear on thoracic CT. The~     investigators' hypothesis is that diagnostic lung ultrasound will not cause lung hemorrhage~     in humans. Damage to the lung in animal models has been shown to be mechanical rather than~     thermal in nature and evidence suggests that this injury is likely not from inertial~     cavitation but from alveolar resonance. Models of the alveolar resonance theory predict that~     hemorrhage should not happen in adult human lungs if the ultrasound frequency is higher than~     1.69 MHz and mechanical index (MI) is less than 1.9 which is maintained with standard~     scanning protocol for thoracic ultrasound. A previous human study showed no gross~     macroscopic lung hemorrhage in patients undergoing transesophageal echocardiography with~     pressures of 2.4 MPa and MI 1.3 with exposure durations ranging 7-68 minutes.~      The investigators propose to perform a routine lung ultrasound exam on patients who are~     scheduled to undergo chest computed tomography evaluation for pulmonary embolus as part of~     their routine care. The ultrasound will be performed immediately prior to CT imaging and~     markers will be placed on the patients chest to ensure the correct lung tissue is being~     evaluated. There will be two sham markers so the radiologist will be blinded to which tissue~     had ultrasound applied and which did not. The CT scan will then be evaluated per routine and~     also to see if there are signs of microscopic or macroscopic hemorrhage under the skin~     markers.~   "
46094|NCT02453659|"~     The long-term goal of this program of research is to develop and disseminate an efficacious,~     group-based distress tolerance treatment for weight concern (DT-W) that will significantly~     increase smoking cessation rates among women. The objective of this project is to conduct a~     preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education~     (HE) comparison intervention, in which both groups also receive standard behavioral smoking~     cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and~     examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking~     outcomes at 1-, 3-, and 6-month follow-ups.~   "
46095|NCT02453646|"~     A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the~     NexSite HD Catheter for long term vascular access for hemodialysis.~   "
46096|NCT02453633|"~     The project will be done at the ear, nose and throat outpatient department at Lovisenberg~     Diakonale Hospital (LDS) in 2015-2016. About 12% of patients with appointments at the~     surgical outpatient clinic at LDS do not attend their appointment even after receiving both~     letters and shot message service (SMS) reminders. Persuasion theory suggests that the SMS~     reminders may be more effective if the text appeals more to the patient's feelings. The~     project is designed as a randomized controlled trial in which the control group receives the~     standard text that has neutral content and the intervention group receives a more~     emotion-based SMS reminder. The aim is to determine whether the more emotional text reduces~     the proportion of patients who do not show up for their scheduled appointment at the~     surgical outpatient clinic.~   "
46097|NCT02453620|"~     This phase I trial studies the side effects and best dose of entinostat and nivolumab when~     given together with ipilimumab in treating patients with solid tumors that have spread to~     other places in the body and usually cannot be cured or controlled with treatment~     (metastatic) or that cannot be removed by surgery (unresectable) or human epidermal growth~     factor receptor 2 (HER2)-negative breast cancer that has spread from where it started to~     nearby tissue or lymph nodes or other parts of the body. Entinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth (locally~     advanced/metastatic). Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere~     with the ability of tumor cells to grow and spread. Giving entinostat and nivolumab together~     with ipilimumab may be a better treatment in patients with solid tumors.~   "
46098|NCT02453607|"~     In this research proposal, the investigators will focus on methods to optimize the~     therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite~     levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study~     will also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX~     with dendritic cells in both healthy subjects and patients with Crohn's disease~     (proliferation, maturation, cytokine profile, apoptosis, gene expression).~   "
46099|NCT02453594|"~     This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory~     classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed~     after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or~     failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a~     Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive~     auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have~     failed to achieve a response to or progressed after auto-SCT and have not received BV post~     auto-SCT.~      The primary study hypothesis is that treatment with single agent pembrolizumab will result~     in a clinically meaningful overall response rate.~   "
46100|NCT02453581|"~     A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge~     inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the~     experimental anti-malarial product, OZ439.~   "
46101|NCT02453555|"~     This trial will compare the use of fiixed dose conbination of empagliflozin and linagliptin~     to linagliptine alone in patient with type 2 diabetes mellitus~   "
46102|NCT02453542|"~     Background~      The treatment of haemophilia A and B has been revolutionized by the use of factor~     concentrate, both as prophylaxis and to treat bleeding episodes (on-demand treatment).~     However, despite its advantages, repeated treatment with factor concentrate can lead to~     development of inhibitors (antibodies) towards the coagulation factor in the concentrate.~     Another patient group in which the bleeding symptoms are difficult to treat because of~     inhibitors towards coagulation factors, most commonly FVIII, is patients with acquired~     haemophilia. Patients with high antibody titers exhibit a deficient or no response to factor~     concentrates and usually need treatment with bypassing agents, namely factor eight inhibitor~     bypassing agent (FEIBA®, Baxter) och recombinant activated factor VII (rFVIIa, Novo-Seven®,~     Novo Nordisk). The effect of the treatment cannot be accurately monitored by traditional~     coagulation tests.~      The aim of the study is to evaluate the utility of the global haemostatic methods in~     patients with haemophilia with inhibitors. The objective is to improve the monitoring of the~     treatment effect and thus increase the safety of the patient and the effectiveness of the~     treatment.~      Patients and methods~      Patients~      The primary cohort will consist of fifteen patients with inherited haemophilia with~     inhibitors as well as five adult patients with acquired haemophilia who are followed up at~     the Coagulation Department of the Karolinska University Hospital, Stockholm, Sweden.~      Blood samples will be collected from those patients at specific time points (see Design of~     the study) during the course of two years (for each patient). The treatment (type, dose,~     duration) will be determined by the treating physician.~      Methods (selection)~        -  Thrombin generation (Calibrated Automated Thrombogram, CAT® and a commercial kit from~          Siemens®).~        -  Overall haemostatic potential (OHP)~      Design of the study~      Timeframe for blood sampling: i) baseline (inclusion in the study), and ii) prior and after~     administration of bypassing agents to either treat bleeding symptoms or before an invasive~     procedure or as prophylaxis.~      Data analysis~      The variations in coagulation markers measured as described above (Methods) will be~     associated to the clinical symptoms (bleeding), the level of coagulation factors (if~     measurable) and the titers of the inhibitors.~   "
46103|NCT02453529|"~     This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy~     adult male and female subjects.~      Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1.~     Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15~     minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873.~     The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing.~     Blood samples for determining plasma WCK 4873 concentrations will also be collected within~     15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each~     subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the~     outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of~     WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn~     for determining plasma WCK 4873 concentrations at 48 hours after the third dose.~      Safety will be assessed throughout the study by adverse event monitoring, clinical~     laboratory tests (including liver function tests), ECG, physical examination and vital sign~     monitoring. Subjects will discontinue study drug administration in the event of AST/ALT~     elevation of greater than 3 times the upper limit of normal.~   "
46104|NCT02453516|"~     Surgery for breast cancer is associated with significant pain. The serratus nerve block~     targets the interfascial plane either below or above the serratus muscle, blocking thereby~     the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized~     controlled double-blinded study is to see whether the addition of a serratus nerve block to~     a general anesthesia results in a better postoperative pain control in patients undergoing~     surgery for breast cancer.~   "
46105|NCT02453503|"~     Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral~     cavity which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP~     currently. The main focus of treatment is to reduce the duration and severity of the~     symptoms. This study was designed to determine and compare the parameters of improvement in~     patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide~     mucoadhesive film and licorice mucoadhesive film.~      Methods and materials :The study was randomized by double-blind clinical trial . Patients~     with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical~     Sciences in Isfahan University participated voluntarily. The patients were divided into two~     groups that were including 30 samples in each group. The first group was treated with~     triamcinolone mucoadhesive film and the second group were treated with licorice mucoadhesive~     film. Data were analyzed by using the Mann-Whitney test and t-test in SPSS software.~   "
46106|NCT02453490|"~     This study is a multicenter ,randomization, open control study to evaluate the efficacy and~     safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the~     peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).~   "
46107|NCT02453477|"~     This is a phase I/II study evaluating safety and efficacy of autologous hematopoietic stem~     cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin~     gene for the treatment of patients affected by transfusion dependent beta-thalassemia~   "
46108|NCT02453464|"~     This is an open-label, multicenter, dose-escalation study designed to assess the safety,~     tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab)~     Injection in combination with FOLFIRI in patients with previously treated metastatic~     colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage.~     Once the maximum tolerated dose (MTD) of Sevacizumab has been established, additional~     patients will be enrolled in the cohort-expansion stage (Stage 2).~   "
46109|NCT02453451|"~     Patients received a MitraClip procedure because of a leakiness of their mitral valves.~     During this procedure the atrioventricular valves were stuck together permanently via a clip~     which leads to a reduction of leakiness. As a result of this procedure a small hole remains~     at the cardiac septum which is called an atrial septal defect (ASD). In most cases the hole~     will close after a few weeks or months, but in many other cases not. Until now there is no~     exact data about the effect of this hole on the filling pressure in the heart or on the~     blood flow behaviour. So the aim of this study is a precise analysis of the blood flow~     mechanics during and after the MitraClip procedure to identify criteria to get more~     informations for a better strategy and regulation of the MitraClip procedure.~   "
46110|NCT02453438|"~     The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating~     in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is~     to improve the nation's capacity to conduct comparative effectiveness research that reflects~     questions of greatest importance to patients and other stakeholders. A robust data~     infrastructure will be built that, in phase one, allows participants to contribute data,~     including those from participant questionnaires, visualize their own health information in~     intuitive and helpful ways, and share their aggregated de-identified health information~     within and outside of the Network.~   "
46111|NCT02453425|"~     The purpose of this study is to evaluate renal effects of 3 different levels of mean~     arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic~     shock, we will adjust mean arterial pressure (MAP) to three different levels, using~     norepinephrine. At each level of MAP, central and renal hemodynamics and oxygenation states~     will be measured. Analysis will be made to evaluate at which MAP renal function and~     oxygenation is least affected negatively.~   "
46112|NCT02453412|"~     Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement~     therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For~     hemodialysis a vascular access is necessary, preferable an arteriovenous fistula (AVF) in~     which a vein is directly anastomosed to an artery. In order to use the AVF for hemodialysis~     three criteria have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is~     at least 6 mm, and the AVF is located less than 6 mm under the skin. Unfortunately,~     approximately half of the patients (50%) are confronted with an AVF that does not meet these~     criteria; the so called non-maturation or primary failure. In case of non-maturation the AVF~     is not only unusable for dialysis, but also requires reinterventions on short- and~     long-term. Firstly to mature the AVF, and secondly, when the AVF is matured, to keep the~     vascular access. Using a computational simulation postoperative flow can be predicted. Based~     on patient-specific duplex measurements, the model can calculate the flow that can be~     expected following vascular access surgery for all AVF configurations; fore- or upper arm.~     These calculations lead to an advice which configuration is indicated; a flow that exceeds~     600 mL/min, leading to maturation. Potentially the aforementioned 50% of non-maturation can~     be reduced. The patient then has an adequate vascular access and reinterventions are~     adverted, resulting in a decrease of costs, hospital demand, and an increase of the~     patients' quality of life. When the expected reduction of non-maturation is confirmed, the~     computational tool can be offered to other hospitals.~   "
46113|NCT02453399|"~     This study will evaluate transcutaneous electro stimulation device developed by Siano for~     adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for~     migraine sufferers.~   "
46114|NCT02453386|"~     Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).~   "
46139|NCT02452086|"~     The purpose of this study is to examine the changes of factors including Vascular~     Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible~     factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface~     area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser~     Therapy(LLLT).~   "
46115|NCT02453373|"~     The aim of this study is to assess the feasibility of using the Life Recovery Systems~     ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke.~     This feasibility clinical study will enroll a total of 30 patients with acute ischemic~     stroke at two clinical centers. Subjects will receive hypothermia plus conventional therapy~     (such as IV-tPA therapy if indicated). Endpoints will include feasibility of cooling,~     adverse events, and neurological recovery in comparison with matched historical controls.~   "
46116|NCT02453360|"~     Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain.~     This pain can oftentimes be severe enough to limit participation in physical therapy and~     ultimately delay discharge resulting in increased cost. Several strategies have been~     developed in an effort to decrease postoperative pain following TKA while maintaining lower~     extremity strength and maximizing participation in physical therapy. Recently, adductor~     canal blockade has gained popularity as it is reported to provide analgesia to the anterior~     knee without resulting in significant quadriceps muscle weakness. However, few studies have~     carefully evaluated the impact of volume of injection of local anesthetic into the adductor~     canal on motor weakness or pain control. The ability to achieve similar pain control with~     decreased volumes of local anesthetic would allow the surgery team to apply more local~     anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be~     associated with a decreased risk of local anesthetic toxicity. This study aims to carefully~     evaluate this relationship using a physical therapy evaluation method that relies on both~     motor strength and pain control. In addition, the investigators hope to carefully evaluate~     motor strength using a novel method of strength measurement in an effort to further evaluate~     the impact of volume of injection of local anesthetic into the adductor canal on motor~     strength.~   "
46117|NCT02453347|"~     The primary aim of this proposed study is to gather preliminary data for CES use in treating~     PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.~   "
46118|NCT02453334|"~     Phase III, multicenter, randomized, double-blinded, prospective study with two parallel~     treatment groups. Patients who present to the hematologist/oncologist and satisfy all~     inclusion and exclusion criteria will be eligible for participation in this 18-week study.~   "
46119|NCT02453321|"~     Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs)~     offer adequate or equal analgesia and may promote better performance in early rehabilitation~     following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral~     Nerve Block (FNB). A common feature of these studies has been the use of moderate to high~     concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when~     injected by a large motor nerve will inevitably cause weakness. However, the practice at our~     institution has long been a continuous femoral nerve block (CFNB) with a lower concentration~     local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have~     performed several thousand CFNBs using this technique which has offered the advantage of~     minimal motor weakness and adequate analgesia.~      The primary goal of this study is to determine if our established practice of using a low~     concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the~     femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice~     of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC)~     - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local~     anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in~     the 48-hour postoperative period.~      Definitions of the location of the adductor canal are debated heavily in literature, but~     they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the~     distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study~     will require placement of the continuous ACB no more distal than 20cm cephalad to the~     superior pole of the patella due to placement prior to surgery and the need to keep the~     dressing out of the operative field. The CACB catheter will also not be placed any more~     proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these~     measurements will create an exclusion for patients with an iliac-to-patella distance less~     than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview~     on the day of surgery with a measuring tape. External palpable landmarks of the Anterior~     superior iliac spine and the superior pole of the patella will be used.~      The primary outcome is based upon the ability to perform rehabilitation exercises~     postoperatively to the extent that criteria for discharge can be met. The primary outcome~     measured is the time at which a patient gains the ability to successfully perform a 75-feet~     unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary~     outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary~     outcomes will be the number of days admitted prior to discharge, and average pain scores on~     DOS, POD#1, and POD#2. The Day of discharge will also be used as a secondary outcome.~     Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.~   "
46120|NCT02453308|"~     This study is an open-label randomised trial comparing standard ACT treatment with matching~     triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and~     tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1~     site in Africa. There are 2 arm study groups that have 2 treatment arms each.~      Study group A:~      A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days.~     plus: Amodiaquine for 3 days.~      Study group B:~      B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine~     for 3 days. plus: Mefloquine hydrochloride for 3 days.~      According to the WHO guideline, all patients except for children under the age of 1 year or~     a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.~   "
46121|NCT02453295|"~     The specific objectives and research questions of the proposed study are:~        1. a. Administer a group rehabilitation intervention to address loss and foster hope in 30~          participants with upper and lower limb SLC --15 in an intervention group (IG), 15 in a~          control group (CG) at each of two research sites (Montreal, QC and Saint John, NB) for~          a total sample size of 60. Data about its impact will be collected by means of~          audiorecording 8 intervention workshops at each site and administering questionnaires~          (multiple timepoints).~           b. Test the intervention - Main hypothesis: The intervention group will show~          improvements in psychosocial well-being.~        2. Assess feasibility (e.g., review our accrual strategies, randomization of participants,~          and data collection) via the completion of process logs.~   "
46122|NCT02453282|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy~     versus platinum-based SoC chemotherapy in the first-line treatment of patients with~     epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type~     locally advanced or metastatic NSCLC~   "
46123|NCT02453269|"~     The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program~     against childhood obesity.~   "
46124|NCT02453256|"~     This study will assess the efficacy and safety of tocilizumab compared with placebo in~     participants with SSc across approximately 120 global study sites. The study will consist of~     a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label~     treatment period.~   "
46125|NCT02453243|"~     Many patients at risk for suicide are discharged from the ED with little or no intervention.~     Evidence-based suicide prevention interventions, like universal screening and safety~     planning should be adopted in clinical practice to help prevent suicidal behavior. This~     study will test the long-term sustainability of the nurse administered universal screening~     implemented in the original ED-SAFE study. Also, the investigators will test what impact~     implementing a new personalized Safety Planning Intervention guided by Lean has on suicide~     composite outcomes.~      The ED-SAFE-2 will use a stepped wedge design where the original eight ED-SAFE sites will~     collect quantitative and qualitative data during the three phases: Baseline, Implementation,~     and Maintenance. Using this data, as well as data from the original ED-SAFE study, the~     ED-SAFE-2 will examine both within and between site differences for existing screening~     practices and new safety planning procedures. Most of the data collection on outcomes will~     be done by retrospective chart review.~      The Safety Plan Intervention will be adopted into routine clinical care for patients who~     screen positive but are set to be discharged. Each step is presented by the clinician and~     the responses are recorded on a templated form. After completion of the safety plan, the~     clinician helps the patient identify the most helpful aspects of the plan, ascertains the~     likelihood of actually using it, and addresses any potential barriers to use. The patient~     keeps the safety plan to use as a reminder during times of escalating distress or crisis.~      A Lean Implementation Strategy will be used to ensure that adoption of the intervention is~     fully supported vertically and horizontally within the organization, infrastructure is built~     that supports the efforts, and that the protocols fit naturally within roles,~     responsibilities, and clinical flow.~      Consistent with the RFA's emphasis, the intervention target will be the clinician's behavior~     of safety planning. All emergency mental health and nursing personnel at the sites will be~     trained on safety planning, and Lean will be used to help ensure the safety planning is~     being implemented properly and consistently. The mechanisms of action of the combination of~     the safety planning training and Lean will be studied, allowing the team to establish both~     the effect the intervention has on the intervention target but also on the mechanisms of~     action comprised of departmental culture change and infrastructure support.~   "
46191|NCT02452489|"~     With Diabetic gastroparesis as the research object, by the method of multi-center RCT and~     single cavity and different acupuncture acupoints compatibility treatment of diabetic~     gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as~     validity checking means, for single cavity with different acupoints compatibility evaluate~     clinical efficacy of treatment of diabetic gastroparesis.~   "
46126|NCT02453230|"~     Since the 1960's, perinatal mortality in the United States has been declining at a steady~     rate. This decline has thought to be the result of improved surveillance of normal and~     abnormal fetal behavior and using that information to determine those babies at risk for~     stillbirth.~      There are many tools available for surveillance. One of these tools, the bio-physical~     profile (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal~     behavior . This test has been used for about the last 30 years with good safety and~     efficacy. The ultrasound evaluation includes monitoring fetal breathing, fetal gross and~     fine movement and amniotic fluid evaluation. NST and BPP have been found to have similar~     ability to predict fetal well-being, with similar safety and ease of performance. Several~     studies have observed the effect of sound as well as light on the NST and have found that it~     can shorten testing time without altering its ability to be interpreted properly or~     affecting fetal safety. However, similar studies have not been done with the BPP. Light~     stimulation has been proven to be safe for both the mother and the fetus with no harm having~     been demonstrated when used with NST.~   "
46127|NCT02453217|"~     The investigators programme of research will evaluate an existing physical health care~     screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve~     the physical health wellbeing of people with a SMI.~      This pilot clustered randomised controlled trial aims to establish the potential efficacy~     and acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical~     health of people with severe mental illness.~   "
46128|NCT02453204|"~     Research has shown that reducing the time spent sitting can reduce the risk of many~     diseases, such as diabetes and heart disease, and improve health. It is estimated that many~     older adults typically spend 70% of their waking day sitting, but little is known about~     whether reducing sitting promotes health and well-being in this age group. The aim of this~     research is to investigate the health effects of reducing sitting time by replacing it with~     short periods of standing or walking in adults over the age of 65.~   "
46129|NCT02453191|"~     The purpose of this research study is to determine the safety and tolerability of talimogene~     laherparepvec when combined with radiation therapy.~      Approximately 32 people will take part in this study conducted by investigators at the~     University of Iowa.~   "
46130|NCT02453178|"~     Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's~     Disease, there is a lack of understanding of how exercise protects the aging brain. The~     proposed research takes a novel approach to this problem by testing the concept that there~     are acute, direct effects of exercise in the same brain regions that are affected by chronic~     exercise training. If the investigators are successful, the acute paradigm will allow us to~     determine the critical exercise parameters that modulate brain function in humans using only~     a single exercise dose.~   "
46131|NCT02453165|"~     Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.~      The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault~     at the end of a total laparoscopic hysterectomy, in order which of these two modalities of~     suturing is associated with a lower risk of dehiscence.~   "
46132|NCT02453152|"~     This study is a longitudinal study evaluating the severity and progression of respiratory~     muscle function in patients with X-Linked Myotubular Myopathy (XLMTM) aged 0-14.~   "
46133|NCT02453139|"~     Obesity, known to be associated with a pro-inflammatory, pro-thrombotic humoral milieu,~     confers a worse prognosis in prostate cancer (PrCa). Circulating tumour cells (CTCs) are~     identified in the blood in advanced cancer. Their quantitation provides prognostic~     information. Cloaking of CTCs by adherent platelets impedes natural killer (NK)-cell~     clearance of CTCs from the circulation, enhancing metastatic spread. NK-cell function in~     blood and in solid organs is quantitatively and qualitatively reduced in obesity. Platelet~     cloaking may be enhanced in obesity due to the pro-inflammatory, pro-thrombotic state, and~     may be a mechanism for worse cancer-specific outcomes in this group. Obesity and its~     biochemical effects may be influenced by lifestyle changes such as exercise. Physical~     activity reduces levels of systemic inflammatory mediators and so an aerobic exercise~     intervention may represent an accessible and cost-effective means of ameliorating the~     pro-inflammatory effects of obesity. The ExPeCT trial will determine if a prescribed~     exercise intervention can ameliorate the degree of platelet cloaking in obese and non-obese~     men with advanced prostate cancer.~   "
46134|NCT02453126|"~     This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis~     (EoE) is characterized by abnormal esophageal structure and compliance compared to non~     fibrostenotic EoE and that distinctive cellular and molecular profiles predict the~     fibrostenotic phenotype. This study aims to define and assess the changes that occur in the~     structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along~     with characterizing the histologic and molecular patterns in fibrostenotic EoE.~   "
46135|NCT02453113|"~     The purpose of this is that the researcher can use low power Near Infrared laser treatment~     non-painful and non-damaging dose to changes the skin properties.The researcher can prove~     that signaling and a significant increase in the number of skin cells in skin tissue exposed~     to the laser can improve the human skin immune system to help improve human body response to~     vaccines.~   "
46136|NCT02453100|"~     An intervention consisting of group and home based exercise will be used over 6 months to~     assess whether this is helpful in managing urinary incontinence in elderly village women in~     Bangladesh. This intervention, supplemented by education about managing incontinence, will~     be used in half the villages in the trial. In the other half women will receive only the~     education component.~   "
46137|NCT02453087|"~     This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and~     pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or~     refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the~     safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be~     assessed.~   "
46138|NCT02452099|"~     The main aim of the study was to evaluate the clinical impact of different DMSO~     concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of~     hematopoiesis after autologous hematopoietic stem cell transplantation.~   "
46205|NCT02452307|"~     The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive~     patients with biochemical recurrence after radical prostatectomy treated with a~     prostate-specific peptide vaccine in combination with different immune-adjuvants.~   "
46140|NCT02452073|"~     Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the~     level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due~     to the dosage of radiation, sensitivity of organs to radiation, and some patient~     characteristics, RE can present as either an acute or chronic syndrome. Clinical~     manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia,~     intestinal bleeding, obstruction, and even perforation, which compromise quality of life.~     For many years, radiotherapy of the abdominal or pelvic region is commonly used for a~     significant percentage of patients with rectosigmoid and genitourinary system tumors.~     Different techniques have been developed to prevent the occurrence of radiation induced~     injury. However, the incidence of CRE is expected to continue to rise during the coming~     years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in~     addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now,~     lots of attention is only paid to local complications, there is little report on systemic~     damage of abdominal or pelvic radiotherapy.~      Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating~     triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and~     thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is~     variously known as the nonthyroidal illness syndrome (NTIS). This condition is frequently~     detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid~     hormone metabolism might change during many chronic illnesses as early as 1973. Data has~     shown that about 35-70% of acute and chronic critical conditions were associated with a~     significant abnormal thyroid hormone metabolism, of which LT3S was the most common type.~     Furthermore, these changes have been shown to be associated with disease severity and have~     been connected with poor short-term prognosis.~      To date, there are lots of literatures include detailed reports on the relationship between~     LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus,~     sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been~     undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE~     patients.~   "
46141|NCT02452060|"~     This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center~     study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18~     and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and~     consented during the preadmission visit prior to surgery.~   "
46142|NCT02452047|"~     The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A)~     versus colistimethate sodium + imipenem+cilastatin in the treatment of imipenem-resistant~     bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial~     pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated~     intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).~   "
46143|NCT02452034|"~     This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered~     intravenously (IV) or orally to immunocompromised pediatric participants.~   "
46144|NCT02452021|"~     This is a prospective observational study designed to observe the toxicity and efficacy of~     PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The~     investigators hypothesize that PBS proton RT will be associated with a favorable adverse~     event profile and quality of life, with similar disease control outcomes, relative to~     historical comparisons of patients treated with photon RT.~   "
46145|NCT02452008|"~     The primary objective of this study is to compare the progression free survival (PFS) of~     patients with metastatic castration-resistant prostate cancer treated with enzalutamide in~     combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).~   "
46146|NCT02453074|"~     The purpose of this study is to design and test the feasibility of a system to survey~     patients regarding the outcome of acute care visits and to report back to the healthcare~     providers.~   "
46147|NCT02453061|"~     In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤~     40) in a randomized, double-blind, controlled study in 2 centers (France and the~     Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n =~     50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an~     open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be~     evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and~     brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine,~     during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS,~     TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient~     quality of life will be evaluated with qualitative research methods after 6 months and with~     the SF-36 questionnaire before and after treatment; biological tolerance and compliance will~     be evaluated by routine biochemical blood tests, plasma and urine measurements of~     triheptanoin oil derivatives and patient report.~   "
46148|NCT02453048|"~     This study evaluates the safety and immunogenicity of a higher dose formulation of a new~     live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal~     colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce~     the live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose),~     single centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis~     strain BPZE1 given as a single intranasal dose to healthy adult volunteer.~   "
46149|NCT02453035|"~     The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well~     as treatment outcomes with DESolve in patients with CAD.~   "
46150|NCT02453022|"~     The current study will help to increase our understanding of the pharmacokinetics (PK) of~     danirixin. The primary objective of the study is to estimate the relative bioavailability of~     danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and~     tolerability information for oral administration of danrixin HBr tablets in elderly subjects~     will also be obtained. Secondarily, this study will evaluate effect of food on PK of~     danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of~     danirixin HBr. The outcome of this study will contribute to the selection of the most~     appropriate formulation/dosing regimen for future studies.~      This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy~     elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The~     Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will~     be done within 3 to 10 days post last dose.~   "
46151|NCT02453009|"~     The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to~     improve the disease control in first line CRPC patients.~   "
46152|NCT02452996|"~     In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients~     will be evaluated in healthy male volunteers.~   "
46153|NCT02452983|"~     This study will investigate the effects of sertraline in people with low-risk~     myelodysplastic syndrome (MDS). It is hoped that sertraline will decrease disease~     progression and reduce the need for blood transfusions.~   "
46154|NCT02452970|"~     The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic~     agent, which turns on a number of beneficial genes that the tumor has silenced, can~     resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and~     cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label~     study, which means that patients will know what treatments they are receiving, is EPIC, a~     hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and~     Cholangiocarcinoma.~      The study treatment is divided into two stages. During the first stage, patients will~     receive RRx-001, which is administered intravenously weekly, for a fixed time period of six~     weeks. At that time the second stage starts in which cisplatin and gemcitabine are~     reintroduced for as long as the tumors respond to them to determine whether resensitization~     has occurred.~      The primary objective of this clinical trial is to evaluate the progression-free survival~     (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.~   "
46155|NCT02452957|"~     The aim of this observationnal post-marketing study is to provide additional information on~     the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty ,~     in usual surgical practice.~   "
46156|NCT02452944|"~     Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder~     tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can~     trigger an inadvertent adductor muscle spasm, which can cause a serious complication like~     bladder perforation.~      General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the~     adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be~     an alternative anesthesia for TURB, but adductor spasm can also be induced because of~     incomplete ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance~     the safety, efficacy and shortening the onset time of ONB.~      Some papers describe that comparable ONB can be done using ultrasound only without nerve~     stimulator, in which there is a principle that obturator nerve runs along a given pathway.~     Basically, obturator nerve is divided into two branches after exiting the obturator canal.~     The anterior branch is located in the fascial planes among adductor longus, adductor brevis~     and pectineus muscles, and the posterior branch is located between the adductor brevis and~     adductor magnus muscles at the inguinal area. But it has been known that there are many~     branching patterns of obturator nerve and high anatomic variability in the inguinal area in~     a cadaver study. And subdivisions of obturator nerve in the inguinal area have been~     described.~      Therefore, this study was conducted to investigate the success rate of ultrasound-guided~     obturator nerve block with interfascial injection approach group (US-IFI; experimental~     group) was comparable to ultrasound-guided obturator nerve block with nerve stimulating~     approach group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated~     adductor muscle twitching patterns at the inguinal region when the ONB was performed.~   "
46157|NCT02452931|"~     This study determines the effectiveness of leuprolide acetate 45 mg for injectable~     suspension for treatment of children with Central Precocious Puberty.~   "
46158|NCT02452918|"~     This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV)~     infusion of oritavancin in adult subjects on chronic warfarin with acute bacterial skin and~     skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive~     pathogens.~      An additional group of patients with ABSSSI, who are not on concomitant warfarin therapy,~     will also be enrolled to obtain information regarding the potential for antibody production~     following a single dose of oritavancin administration in patients.~   "
46159|NCT02452905|"~     Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral~     infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the~     duration and severity of respiratory symptoms caused by bronchiolitis. Half of the~     participants will receive NTZ while the other half will receive a placebo.~   "
46160|NCT02452892|"~     The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of~     Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who~     are treatment resistant.~   "
46161|NCT02452879|"~     The purpose of this study is to determine whether electroacupuncture is effective in the~     treatment of overactive bladder.~   "
46162|NCT02452866|"~     This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of~     SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent~     girls with bacterial vaginosis.~   "
46163|NCT02452853|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent~     cause of cancer death worldwide. Hepatic resection (HR) is the conventional ''curative''~     treatment for HCC. In both the European and the United States Proposed Guidelines for HCC,~     HR is recommended only for patients with preserved liver function and with early stage HCC.~     Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced~     cirrhosis, only 10% to 30% of HCCs are amenable to such a ''curative'' treatment at the time~     of diagnosis. Transarterialchemoembolization (TACE) has become the most popular palliative~     treatment for patients with unresectable HCC, and it is no longer considered as a~     contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long-term~     outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. To~     improve on the results of treatment of HCC with PVTT, attempts have been made to perform HR~     for these patients. HCC with PVTT remains a contraindication to liver transplantation~     because of the high rate of tumor recurrence, and because of the severe shortage of donor~     organs. HR remains the only therapeutic option that may still offer a chance of cure. With~     advances in surgical techniques, it has become feasible to remove all gross tumors,~     including PVTT, which has extended to the main portal vein, safely by surgery. More HCC with~     PVTT, which previously were considered as unresectable, have become resectable.Recent~     studies have even shown favorable long-term survival outcomes of HR in well-selected cases~     of HCC with PVTT. However, the recurrence rate after HR for PVTT is still high and the~     prognosis for patients with HCC with PVTT is very poor. Systemic chemotherapy is considered~     to be one of the main treatments for malignant tumors. HCC is known to be highly refractory~     to conventional systemic chemotherapy because of its heterogeneity and multiple etiologies.~     Before the advent of the molecular-targeted agent sorafenib, which has subsequently become~     the standard of care, no standard systemic drug or treatment regimen had shown an obvious~     survival benefit in HCC. Nowadays, there is no systemic chemotherapy regimen had been~     definitively recommended as the standard for treating HCC. Clinical activity of several~     regimens containing oxaliplatin (OXA) in advanced HCC had been demonstrated in phase II~     studies. In a phase II study of the FOLFOX4 (infusional fluorouracil [FU], leucovorin[LV],~     and OXA) regimen in Chinese patients with HCC, median overall survival (OS) was 12.4 months,~     mean time to progression was 2.0 months, and the response rate (RR) was 18.2%. The safety~     profile was acceptable. Recently, the results of a phase Ⅲ randomize study showed that~     FOLFOX4 served as palliative chemotherapy can induce higher overall survival,~     progression-free survival and response rate comparing to doxorubicin in patients with~     advanced hepatocellular carcinoma from Asia. The safety data was also acceptable.So the~     investigators' hypothesis is that post-surgery FOLFOX4 can reduce high recurrence rate after~     HR for HCC with PVTT. The aim of this open-label, single prospective study is to evaluate~     the efficacy and safety of HR combined with FOLFOX4 systemic chemotherapy for patients with~     HCC with PVTT.~   "
46164|NCT02452840|"~     The purpose of this prospective observational study is to assess the potential clinical~     effects of adjunctive verteporfin photodynamic therapy (PDT) for persistent disease activity~     among patients with neovascular age-related macular degeneration (NV AMD). No specific~     interventions will occur as part of the study; participating subjects undergoing PDT as part~     of standard-of-care will be asked to consent to prospective collection of data from their~     medical records for up to five years from the date of consent, including results from~     ophthalmologic exams, imaging, and treatments. The primary study outcome will be the~     percentage of subjects with resolution of persistent disease activity at six months post-PDT~     treatment. Aside from a small risk of loss of confidentiality, risks associated with this~     study are no greater than those related to standard of care.~   "
46165|NCT02452827|"~     In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been~     found in pathological studies. The physiologic function of these fibers is still unknown.~     Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers~     undergo changes in patients suffering from primary chronic neck pain. In addition, the~     biomechanical parameters of neck movements in these patients will be correlated with the~     imaging findings.~   "
46166|NCT02452814|"~     Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of~     Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic~     Hepatitis C Virus Genotype 1 Infection~   "
46167|NCT02452801|"~     This study will evaluate the effect of various degrees of hepatic function on the~     pharmacokinetics and safety of ALKS 5461.~   "
46168|NCT02452788|"~     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared~     to usual care, in improving medication adherence behaviour of ambulatory hemodialysis~     patients.~   "
46169|NCT02452775|"~     This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide~     and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate~     vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian,~     fallopian tube, or primary peritoneal cancer.~   "
46206|NCT02452294|"~     The study will enrol adult female and male patients with BRAF wild-type melanoma and brain~     metastases who are not eligible for surgery or radiosurgery and failed prior therapy with~     ipilimumab, and patients with BRAF V600 mutation-positive melanoma and brain metastases who~     are not eligible for surgery or radiosurgery and who failed prior therapy with a BRAF~     inhibitor.~   "
46170|NCT02452762|"~     Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory~     health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis~     that deficiency might represent a modifiable risk factor for outcomes in critical illness.~     In recent years, dozens of adult studies have reported both high deficiency rates, and~     associations between lower vitamin D levels and organ dysfunction, health resource~     utilization, and mortality in the intensive care unit (ICU). More recently, similar~     observations have been made in critically ill pediatric populations. The cumulative body of~     basic science and clinical literature demonstrates that deficiency is common in critical~     illness and rapid normalization of vitamin D status could improve clinical outcomes and/or~     reduce health care costs. However, before conducting a phase III trial to determine whether~     restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing~     regimen must be identified. Consequently, the investigators propose a phase II, double blind~     randomized controlled trial to determine a loading therapy dosing regimen that can safely~     and rapidly normalize vitamin D status in critically ill children.~   "
46171|NCT02452749|"~     This single-arm, open-label study will assess the safety and tolerability of one daily~     tablet of a commercially available cardiovascular health dietary supplement by questionnaire~     and blood markers in adults with borderline to mild hypertension over a 6 month period.~     Although the cardiovascular health dietary supplement being investigated has been on the~     market for over 20 years, prospective safety data and blood markers of end organ function~     have not previously been reported.~   "
46172|NCT02452736|"~     The purpose of this study is to conduct a prospective, multi-center, single arm,~     non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible~     for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter~     of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary~     Stent System.~   "
46173|NCT02452723|"~     This study will evaluate the safety of an investigational cell transplantation therapy,~     ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy,~     which consists of human neural stem cells. Three dose levels will be examined in the study.~   "
46174|NCT02452710|"~     This research study is evaluating the usefulness of a placebo (a tablet with no active~     ingredients) on fatigue in cancer survivors.~   "
46175|NCT02452697|"~     This is a randomized, parallel phase II study to evaluate the rates of progression-free~     survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte~     infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001,~     from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related~     donor (Cohort B) following nonmyeloablative allogeneic stem cell transplantation.~     Randomization will be stratified for disease types (myeloid versus lymphoid malignancies).~     Primary endpoints are analyzed separately in Cohort A and B.~      Cohort A: 7-8/8 HLA-matched related or unrelated donor (NK cell enriched-DLI only arm or~     NK cell enriched-DLI + DUK-CPG-001 arm)~      Cohort B: 4-6/8 HLA-matched related donor (NK cell enriched-DLI only arm or NK cell~     enriched-DLI + DUK-CPG-001 arm)~   "
46176|NCT02452684|"~     To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in~     insomnia patients.~   "
46177|NCT02452671|"~     This is a multi-center, non-randomized, observational study to further evaluate the~     effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation.~     Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month~     post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test~     (CAT) score.~   "
46178|NCT02452658|"~     Participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical~     lunch order, and will then be exposed to a second menu with several changes made to the~     menu. Participants will be asked to identify as many changes as possible on this second~     menu, and then complete a survey about their eating tendencies and demographics.~   "
46179|NCT02452645|"~     Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual~     Principal Investigators for this project. The research team will first conduct formative~     research using focus groups and key-informant interviews of Family Child Care Home (FCCH)~     providers. This formative work will inform our adaptation of components of previous~     evidence-based interventions to create a new innovative intervention in both English and~     Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The~     intervention will integrate: a) support from peer counselors with child care experience who~     will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and~     c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the~     effectiveness of the intervention with a Steering Committee and Community Advisory Board~     guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to~     inform the development and adaptation of the FCCH intervention. 2) Conduct a~     cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control~     intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a)~     Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at~     FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods~     will include survey data collection of the FCCH Providers; observation of children's'~     dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for~     physical and survey measurement with permission from their parents.~   "
46180|NCT02452632|"~     The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily~     in combination with metformin and sitagliptin against placebo in combination with metformin~     and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus~     with inadequate glycemic control on metformin and sitagliptin.~   "
46181|NCT02452619|"~     In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen~     therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging~     studies before and after treatment.~      The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI~     in addition to the cognitive tests before and after the treatment.~   "
46182|NCT02452606|"~     The purpose of this study is to investigate the genetic variants of clock and narcolepsy~     genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients~     with Parkinson's Disease.~   "
46183|NCT02452593|"~     Urinary incontinence is defined according to the International Continence Society as any~     involuntary loss of urine, which may bring several negative consequences on women's lives,~     and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20%~     emergency.~      The overactive bladder present in urge incontinence and mixed cause significant impacts on~     people's lives and has a prevalence of 16.5% in the US population.~      Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of~     treatment. Drug therapy using drugs which are not specific for the bladder and are~     associated with many unwanted systemic side effects.~      The results obtained by researchers in several countries using conservative techniques in~     the treatment of patients with urinary incontinence are encouraging and this study aims to~     evaluate carefully and systematically the effectiveness of tibial stimulation technique.~      Importantly, also, that conservative techniques have lower cost than the surgical treatment~     and have virtually no side effects as most of the drugs used in the pharmacological~     treatment of female urinary incontinence.~   "
46184|NCT02452580|"~     This study evaluates possible effects of two different NICU designs; by comparing~     traditional and Family Centered Care in terms of infant nutrition, health and growth, and~     coping by family.~   "
46185|NCT02452567|"~     Obesity is associated with a constellation of cardiometabolic abnormalities (including~     insulin resistance, elevated blood pressure and dyslipidemia) that are risk factors for~     diabetes and cardiovascular disease. Weight loss can improve all of the cardiometabolic~     abnormalities associated with obesity. Up to ~25% of lean people (Body Mass Index[BMI]~     18.5-24.9kg/m2) have many of the cardiometabolic abnormalities associated with obesity and~     are referred to as metabolically abnormal lean (MAL) people. However, the MAL phenotype is~     not well characterized and it is unclear whether weight loss has beneficial metabolic~     effects in already lean people. Accordingly, the goal of this study is to: 1) carefully~     phenotype MAL people and 2) evaluate the effect of moderate (8-10%) diet-induced weight loss~     in MAL people. This will be investigated in 15 MAL (defined as intrahepatic triglyceride~     (IHTG) content ≥5.6% and glycated hemoglobin ≥5.7%, or fasting plasma glucose concentration~     ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140~     mg/dl) men and women. Only lean people who have a BMI>/= 21.0 but <25.0kg/m2 will be asked~     to lose weight to avoid the risk that participants become underweight (BMI <18.5kg/m2)~     during weight loss therapy..~   "
46186|NCT02452554|"~     This phase II trial studies how well lorvotuzumab mertansine works in treating younger~     patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma,~     malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or~     that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab~     mertansine, are created by attaching an antibody (protein used by the body's immune system~     to fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to~     recognize tumor cells so the anti-cancer drug can kill them.~   "
46187|NCT02452541|"~     Severe traumatic brain injury (TBI) is the leading cause of death and disability among~     people under 45 years of age and a major public health problem. Although management of~     severe TBI patients has gradually improved with the establishment of intensive care units~     (ICU) and the development of practice guidelines, mortality is still high - ranging from 30~     to 50% - with 30% of survivors suffering from severe neurological sequelae such as~     neurovegetative states. Families and medical teams are frequently called upon to determine~     reasonable and appropriate goals of care for brain injured patients. They may have to~     consider high intensity of care, but also the withdrawal of life-sustaining therapies in~     accordance with patient wishes. Physicians involved in the care of severe traumatic brain~     injury have expressed serious concerns about hasty decisions made in the absence of~     appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to~     develop a prognostic model by using a multimodal approach of different prognostic indicators~     and their evolution over time in the acute phase of care. The results of this study will~     provide better objective information that will facilitate the shared-decision making-process~     with families and relatives.~   "
46188|NCT02452528|"~     Patients with chronic Hepatitis B Virus (HBV) infection will receive multiple doses of~     ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.~   "
46189|NCT02452515|"~     The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor~     BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable~     patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or~     placebo will be given on top of evidence-based standard of care for left-ventricular~     dysfunction after myocardial infarction. Primary objectives are the analysis of safety and~     tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will~     be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and~     50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients~     treated with placebo.~   "
46190|NCT02452502|"~     Emerging studies have shown that statin treatment has pleiotropic non-cholesterol-dependent~     effects in the setting of ischemic stroke.~      Recombinant tissue plasminogen activator (rt-PA) is the only proven effective pharmaceutical~     treatment for hyper-acute management of ischemic stroke, in spite of the deleterious~     side-effects such as hemorrhagic transformation and reperfusion injury. These harmful~     impacts can be counteracted with proper neuro-protective therapy. In fact, the simultaneous~     use of an effective neuro-protective agent was proved to reduce the comorbid vascular injury~     of rt-PA. In experimental research, high dose of atorvastatin combined with rt-PA can~     significantly reduce infarct volume and improve the neurologic deficits. Previous studies~     showed that fewer than 40% ischemic stroke patients established early reperfusion after~     intravenous thrombolysis, while high dose of atorvastatin was revealed to favor the~     maintenance of cerebral vascular patency and integrity, most likely by reducing thrombosis~     secondary to rt-PA administration. Moreover, it was suggested that statin can sufficiently~     improve the restoration and remodeling of neurovascular unit in cerebral cortex.~      Investigators thus design this study to prospectively investigate whether high dose of~     atorvastatin prescribed within 24 hours after IV-thrombolysis will have a synergic effect to~     improve neurological outcome in acute ischemic stroke patients. Moreover, investigators~     deemed it necessary to non-invasively monitor neuronal and vascular morphological changes in~     brain as an indication of functional improvement. In the investigation centers,~     investigators have developed and implemented novel multimodality MR imaging which can~     dynamically monitor neurovascular remodeling. Therefore, it is worthwhile to evaluate these~     MRI measurements for early prediction of neurovascular reorganization with long term~     functional recovery in thrombolytic stroke patients administrated with high dose of~     atorvastatin.~      The primary target of this study is to prospectively investigate whether high dose of~     atorvastatin (80mg) administrated within 24 hours after IV-thrombolysis will have a synergic~     effect to improve neurological outcome in acute stroke patients, versus moderate dose.~   "
46299|NCT02450981|"~     This clinical study is a phase 1 study which carried out to to evaluate the safety,~     pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab~     biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with~     neovascular wet age-related macular degeneration.~   "
46192|NCT02452476|"~     A multicenter, double blind, randomized, single dose, active-controlled study to investigate~     the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine~     surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with~     respiratory distress syndrome. Main objectives of this study are to investigate the short~     term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in~     terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term~     efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and~     mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36~     weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of~     prematurity.~      Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either~     sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with~     RDS, requirement of endotracheal surfactant administration within 24 hours from birth,~     fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for~     babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.~   "
46193|NCT02452463|"~     This randomized phase II trial studies the side effects and how well nintedanib works~     compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the~     lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are~     undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of~     radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and~     may prevent the growth of new blood vessels. It may also help reduce the recurrence of~     non-small cell lung cancer.~   "
46194|NCT02452450|"~     The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol~     formulations.~   "
46195|NCT02452437|"~     To measure oxycodone's intradialytic mass transfer rate coefficient and oxycodone's removal~     rate using an ODE/PDE hemodialysis model. To implement a rational clinical strategy for~     estimating a patient's post-hemodialysis oxycodone restoration dose using results from an~     ODE/PDE model of hemodialysis.~   "
46196|NCT02452424|"~     The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work~     together to affect cancer cells.~      PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to~     block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study,~     PLX3397 and pembrolizumab are being given together in order to study their combined effects~     on patients' immune responses to their tumors. Tumor-specific immune responses have been~     shown to kill cancer cells and/or to stop tumors from growing.~      Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be~     given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include~     an evaluation of efficacy of this combination in the following 10 tumor types:~        -  Advanced melanoma: anti-PD-1/PD-L1 naïve and CSF1R inhibitor naïve~        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded~        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as~          defined by irRECIST while on therapy~        -  Non-small cell lung cancer~        -  Ovarian cancer~        -  Triple-negative breast cancer~        -  Squamous cell carcinoma of the head and neck~        -  Bladder cancer~        -  Pancreatic ductal adenocarcinoma~        -  Gastric cancer~   "
46197|NCT02452411|"~     The purpose of this study is to determine the differential efficacy of two ways of applying~     homework assignments in the treatment of Adjustment Disorders: 1) using an Internet-based~     emotional regulation therapy system (TEO) and 2) in the traditional way (using reading and~     audio materials).~      The principal hypothesis is that both treatment conditions (TEO and Traditional) will show a~     similar efficacy. All participants will improve significantly on all outcome measures,~     regardless the type of homework assigned (TEO or Traditional) with no differences between~     them.~   "
46198|NCT02452398|"~     This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate~     permanent hair reduction and removal for skin types V and VI using IPL.~   "
46199|NCT02452385|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of CM082 tablets in Chinese Patients With wet-AMD.~   "
46200|NCT02452372|"~     The purpose of this study is to evaluate the safety and tolerability of ALN-AS1 in AIP~     patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of~     ALN-AS1 in AIP patients.~   "
46201|NCT02452359|"~     This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The~     study hypothesis is that the SR580 applicator will improve the appearance of Striae~     Distensae by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months~     follow-up compared to baseline in at least 50% of the study population.~   "
46202|NCT02452346|"~     Study WCMC IST-CTI-MDS evaluates the safety and tolerability of tosedostat in adult patients~     with pathologically confirmed MDS (< 20% blasts in bone marrow, peripheral blood, or both)~     by World Health Organization (WHO) classification after failure of hypomethylating~     agent-based therapy.~   "
46203|NCT02452333|"~     Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness~     and oncologic success of oncoplastic methods and even modified variants of these methods~     reinforced with videoscopic applications. However, primary lumpectomy subjects in these~     studies are mainly patients who have already received the diagnosis of malignancy before the~     surgery. There is not much comprehensive work reported for patients without the diagnosis of~     malignancy. In this regard, the investigators believe the intent of the innovative~     oncoplastic intervention to the breast is underestimated in terms of providing diagnosis~     simultaneously constituting the basic component of surgical treatment. Thus, the purpose of~     this prospectively planned study is to provide and investigate the outcomes of an~     evidence-based oncoplastic approach algorithm for excisional breast biopsies.~   "
46204|NCT02452320|"~     The purpose of this study is to determine if the administration of acetaminophen given~     intravenously (through an IV) beginning during surgery and then for 3 additional doses~     during the first 24 hours post-operatively will reduce the length of time subjects~     undergoing elective sleeve gastrectomy spend in the hospital following this operation.~     Additional questions that may be answered include whether administration of the study~     medication leads to improvement in pain control, a reduction in post-operative nausea and~     vomiting, and an overall improvement in quality of recovery.~   "
46207|NCT02452281|"~     The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab~     is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational~     vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the~     cancer's fingerprint. Injection of the vaccine may cause the patient's immune system to~     recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug~     approved by the FDA for the treatment of metastatic melanoma that boosts immune response.~   "
46208|NCT02452268|"~     This Phase 1 trial will define the side effect profile and the maximum tolerated dose (MTD)~     of hetIL-15, in subjects with advanced metastatic cancers. hetIL-15 is synthetic version of~     a protein normally made in the human body to stimulate white blood cells and may be able to~     boost the number or activity of these cells to attack these cancers~   "
46209|NCT02452255|"~     The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate~     plus propranolol have therapeutic, physiological, and metabolic effects that will improve~     clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.~   "
46210|NCT02452242|"~     ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is~     intended to assess the safety, the tolerability, and pharmacokinetic parameters and to~     evaluate the effect on viral load of repeated oral administrations of ABX464 in patients~     infected by HIV, not previously treated for their HIV.~      Two types of design are intended in this protocol: dosing every 3 days or dosing every day.~     The goal is to determine the best dosing regimen to reduce viral load and minimize adverse~     events.~   "
46211|NCT02452229|"~     Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to~     play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing~     systematic review (Level of Evidence III or higher) describing the unique role as well as~     concurrent infections of these viruses in burns. The aim of this review is to point out the~     clinical differences between these human herpes virus subtypes, to outline established~     therapy approaches, and to provide evidence for virus related morbidity and mortality in~     burns.~   "
46212|NCT02452216|"~     This pilot clinical trial study will assess the inflammatory response of brain tumors or~     other central nervous system conditions in pediatric and adult patients using~     ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of~     inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation~     associated with pathologies in the central nervous system may be helpful for diagnostic and~     prognostic purposes as well as monitoring treatment response of current and future~     immunotherapies.~   "
46213|NCT02452203|"~     The studies proposed in this protocol aim to explore the anxiolytic properties of floating~     as it relates to the central and autonomic nervous system.~   "
46214|NCT02452190|"~     The primary objective of this study is to determine the effect of reslizumab (110 mg)~     administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and~     adolescents with asthma and elevated blood eosinophils who are inadequately controlled on~     standard-of-care asthma therapy.~   "
46215|NCT02452177|"~     Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The~     mechanism for this injury has two possible explanations. The first possible reason is~     intrinsic toxic effects of parenteral nutrition. The second is the basic pathological~     condition of intestinal failure which includes infection, bacterial translocation, etc.~     Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor~     (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor~     for bile acids and promotes enterohepatic clearance of bile acids by controlling the~     expression of genes involved in their transport and metabolism. Considering the activation~     of vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The~     hypothesis of this study is that vitamin D plays a key role in the prevention and reversion~     of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on~     short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic~     change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added~     to this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was~     developed to investigate the importance of FXR signaling pathway in this effect.~   "
46216|NCT02452164|"~     This is a one-center clinical study carried out in Turku, Finland. The study patients will~     be randomly allocated to one of the two parallel study groups (teaching group and control~     group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is~     better when parents have been taught to conduct middle ear examination with a cellphone~     otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at~     evaluating the diagnostic feasibility of cellphone otoscopy.~   "
46217|NCT02452151|"~     The objective of this study is to compare the efficacy of Infliximab-Biosimilar to~     Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative~     colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.~   "
46218|NCT02452138|"~     Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response~     syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory~     response and hypercoagulation can result in microcirculatory dysfunction. When~     microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome~     and death. This is a prospective observational study, and it will not influence the sepsis~     treatment decision of the medical care team. The critically ill severe sepsis patients will~     be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and~     sign the consent form after explanation of the aim and process of the trial by the primary~     investigator or research personnel. After enrollment, the patient will receive serum assay~     of endotoxin activity (EAA) and endocan level. The patient will also receive examination of~     sublingual microcirculation by using the incident dark field video microscope. After 24~     hours, the patient will receive assay of endocan level and examination of sublingual~     microcirculation. This study will record the vital signs, laboratory data, dose of~     vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this~     study will check the survival, stay of intensive care, stay of hospital, ventilator day, and~     the results of culture of pathogens. The patients will be assign to the following three~     groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59~     EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for~     statistical analysis and comparison. The primary goal of this study is to investigate the~     difference of the prevalence of gram-negative bacteria infection, pathogen, infection~     source, microcirculation, the severity of disease, and the prognosis among these three~     groups.~   "
46219|NCT02452125|"~     The objective of this experiment is:~      To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension~     in PD subjects.~   "
46220|NCT02452112|"~     This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy~     and safety of 5% lidocaine patch, following placebo or active patch applications in placebo~     insensitive subjects.~   "
46221|NCT02451995|"~     Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness,~     blackouts and breathlessness. They are caused either by a cluster of abnormal cells within~     the heart, or an electrical short circuit which rotates rapidly around the heart. Sometimes~     these can be controlled with tablets, though owing to side effects many patients want~     something else. Many tachycardia's can be cured by a procedure known as an ablation. In~     essence, either the focus of abnormal cells or the narrowest point of the short circuit~     causing the abnormal heart rhythm (the source) is electrically destroyed (burnt) resulting~     in restoration of the normal heart beat.~      One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two~     chambers of the heart (the atrium). Interestingly, this problem is frequently seen in~     patients who have previously undergone an ablation or surgical procedure for a condition~     called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current~     strategies to find the source during an ablation procedure are technically challenging~     resulting in long procedure times. Sometimes the wrong source is found resulting in ablation~     at the incorrect site.~      Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to~     study. RM displays electrical information within the heart as a series of bars coming out of~     the chamber, with each bar representing signals travelling down the heart. By seeing the~     pattern of electrical information, they believe it will show the pattern of the tachycardia~     better than conventional techniques. In a previous study that they conducted, RM found the~     source of the tachycardia in 80% of the maps, compared to only 50% with the current system.~     Investigators at Imperial College have identified why they did not get 100% and they believe~     that, in future, RM will find the source of the tachycardia first time, and every time.~   "
46222|NCT02451982|"~     This study will be looking at whether CY/GVAX with nivolumab is more effective than CY/GVAX~     alone in altering the pancreatic tumor microenvironment (IL17 expression) to aid in the~     anti-tumor response.~   "
46223|NCT02451969|"~     The purpose of this study is to evaluate the immunogenicity and safety of an investigational~     23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly.~     The control vaccine is a commercialized 23-valent PPV.~   "
46224|NCT02451956|"~     This study is a single arm, single center phase II study of AZD5363 in combination with~     paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or~     amplification as a second line chemotherapy.~      Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed~     of 25 patients.~      Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to~     first dose) and every 8 weeks relative to the date of enrollment, up to week 40, then every~     16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled~     date).~      Study treatment will be continued until objective disease progression.~   "
46225|NCT02451943|"~     The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin~     plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with~     advanced or metastatic soft tissue sarcoma.~   "
46226|NCT02451930|"~     The main purpose of this study is to evaluate the safety and efficacy of the combination of~     necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer~     (NSCLC).~   "
46227|NCT02451917|"~     Chronic kidney disease (CKD) is one of the most common microvascular complications of~     diabetes mellitus, and it is the leading cause of end stage renal disease on developed~     countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic~     therapy and constant dosing adjustments, in order to optimize glycemic control and minimize~     its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied~     through different stages of kidney disease and there is no consensus defining the~     appropriate dosing adjustment based on the glomerular filtration rate (GFR). This research~     project will compare the glycemic response to intensive insulin treatment with NPH insulin~     and basal insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD~     stages 3 and 4. Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary~     to diabetic nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with~     systemic neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric~     disorders and pregnant women. Study design: This study consists of a randomized, cross-over,~     open-label controlled clinical trial. Patients will be randomly divided into two groups:~     GROUP 1 - insulin analog glargine once a day and GROUP 2 - NPH human insulin, three~     applications per day, both group will be treated with insulin lispro at mealtime. The~     laboratory tests will be performed at baseline and 3, 6, 9 and 12 months after the study~     start. During routine medical appointments will be analyzed self- monitoring of capillary~     blood glucose (SMBG) and the hypoglycemia score. After six months the basal insulin will be~     changed, i.e. patients using NPH insulin will receive insulin glargine and patients on~     insulin glargine will be changed to NPH insulin. A CGMS will be carried out at 6 and 12~     months. Methodology: The metabolic profile will be evaluated throughout SMBG; biochemical,~     hormonal and hematological measurements; hypoglycemia score and CGMS. Statistical analysis~     will be performed using comparative descriptive analyzes, such as chi-square distribution,~     t-test and non-parametric tests. Analyze of data CGMS will include the area under the curve~     and the related statistic. Finally, logistic regression models will be adopted to evaluate~     the effect of the treatment on the several variables in question.~   "
46228|NCT02451904|"~     -  The aim is to describe disease mechanisms of severe and cerebral malaria and identify~          new targets for adjunctive therapies.~        -  Despite treatment between 10-30% of patients with severe malaria die.~        -  Metabolic acidosis and cerebral malaria are major complications associated with~          mortality across all age groups. Still, their underlying pathogenesis remains~          incompletely understood.~        -  Using a metabolomics approach, this study aims to characterise the spectrum of acids~          accumulating during acidosis, and investigate patterns of metabolic dysregulation~          associated with coma and seizures.~   "
46229|NCT02451891|"~     This is a clinical trial in which healthy volunteers will be administered experimental Ebola~     vaccines. The investigators will vaccinate four groups of volunteers.~      Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.~      Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA~     EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a~     dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different~     concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from~     viruses which are modified so that they cannot multiply. The viruses have extra DNA in them~     so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that~     the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Oxford and London England. The study will be funded~     by the Wellcome Trust.~   "
46272|NCT02451332|"~     Preventing poor perinatal outcomes is the goal of all prenatal care, yet just who will go on~     to develop preeclampsia or have a growth-restricted baby is notoriously difficult to~     predict. A growing body of evidence suggests inflammatory markers can help predict poor~     outcomes, even prior to, and beyond, the current pregnancy. Our project will measure the~     response of one robust inflammatory marker, C-reactive protein (CRP), to a safe immune~     provocation recommended for all pregnant women (the seasonal influenza vaccine), and to find~     out whether CRP response is associated with increased risk for gestational hypertension,~     preeclampsia, preterm delivery, or birth weight. This work will help inform whether~     inflammatory markers should become part of routine prenatal care.~   "
46230|NCT02451878|"~     The investigators will test the value of an internet self-help package (E-Couch) for~     alleviating sub-clinical social anxiety symptoms in the general population. This is not a~     treatment trial for social anxiety disorder (these people will be directed to seek other~     help and excluded from this study). The investigators will undertake a randomised controlled~     trial involving approximately 2000 people with symptoms of shyness and sub-clinical social~     anxiety. The investigators will compare the effect of the E-Couch intervention compared to a~     wait-list control condition. Over a period of 12 months the investigators will measure the~     effect of using E-Couch self-help on social anxiety symptoms, as well as on mental~     wellbeing, and other secondary outcomes including quality of life, depression and general~     anxiety, and their use of other sources of help.~   "
46231|NCT02451865|"~     This phase Ib trial studies the safety and best dose of binimetinib when given in~     combination with docetaxel in treating patients with previously treated, stage IV non-small~     cell lung cancer. Binimetinib and docetaxel may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
46232|NCT02451852|"~     To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth~     factor receptor T790M mutation-positive non-small cell lung cancer.~   "
46233|NCT02451839|"~     For public health purposes disability is becoming increasingly important as an outcome~     measure. Despite this, there are few data on the effectiveness of adalimumab on disability~     outcomes in patients with Immune-Mediated Inflammatory Diseases (IMIDs), particularly in the~     Phase IV setting. There are even less data available in New Zealand, which did not have the~     opportunity to participate to a major extent in large, multinational, Phase III pivotal~     studies of adalimumab in IMIDs.~      The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple,~     validated, free and easy-to-use generic assessment instrument for health and disability. It~     is applicable across cultures, in all adult populations. It is a responsive measure that can~     show what difference a treatment makes.~      Results from study of effect of adalimumab on WHODAS scores and other Patient-Reported~     Outcomes (PRO) of work activity and well-being will be of interest to a variety of~     stakeholders in the healthcare system including patients, healthcare practitioners and~     payers.~   "
46234|NCT02451826|"~     The purpose of this study is to determine the effect of a contraceptive vaginal ring on~     inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women.~   "
46235|NCT02451813|"~     Recent evidence suggests that injection pressure monitoring may be able to predict needle~     nerve contact in the brachial plexus nerve block model, but little is known about~     multifascicular nerves. The investigators hypothesize that injection pressure monitoring can~     reliably predict needle-nerve contact during femoral nerve block.~   "
46236|NCT02451800|"~     The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga~     program on increasing compliance and improving weight loss while participating in the~     Sanford Profile program. Participants are randomized to one of three groups: in-class yoga,~     yoga by digital video disk (DVD), stretching by DVD. Changes in weight loss and stress~     levels are monitored.~   "
46237|NCT02451787|"~     The investigators major aims are to: determine the vitamin D status of a group of young,~     apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status~     and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial~     health; and, in part 2 of the study, investigate effects of improvement in vitamin D status~     on these biomarkers and other measures of well-being in those young adults shown to be~     deficient in vitamin D.~   "
46238|NCT02451774|"~     Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug~     combination. Measurement of minimal residual disease in bone marrow samples at day 14 of~     treatment is the most powerful early predictive indicator of further relapse, and it can be~     applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has~     been observed that patients who present negative minimal residual disease in bone marrow~     samples at day 7 during induction have a better prognosis than those achieving this at day~     14.~      Relapse represents the main cause of treatment failure that related in the extreme with~     resistance to apoptosis, defining the latter as the principal mechanism of programmed cell~     death; it is also related with the induction of leukemic cells to senescent arrest.~      Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of~     phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms~     and stimulates apoptosis induced by different drugs; thus, it can optimize the~     antineoplastic effect of actual treatments in order to increase the apoptosis of leukemic~     cells. This effect might improve the prognosis of these patients.~      Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order~     to study increased apoptosis and decreased senescence during the remission induction phase~     in pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this~     propose, we will divide patients in two groups, who will receive pentoxifylline or placebo~     depending on the group, in addition to conventional treatment according to the protocol~     standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our~     institution during the remission induction phase. In addition, we will test whether the~     study group exerts an impact on reaching remission earlier as compared with the control~     group.~   "
46239|NCT02451761|"~     Apparently balanced chromosomal rearrangement (ABCR) associated with an abnormal phenotype~     is a rare but problematic event. It occurs in 6% of de novo reciprocal translocations and 9%~     of de novo inversions. Abnormal phenotype, including intellectual disability and / or~     multiple congenital anomalies (ID/MCA) may be explained either by associated cryptic genomic~     imbalances detectable by array-CGH or by gene disruption at the breakpoint. However,~     breakpoint cloning using conventional methods (i.e., fluorescent in situ hybridization~     (FISH), Southern blot) is often laborious and time consuming and cannot be performed~     routinely. Without complete investigation of these rearrangements, genetic counseling is a~     real challenge. Recently, the investigators and others showed that Next-Generation~     Sequencing (NGS) is a powerful and rapid technique to characterize ABCR breakpoints at the~     molecular level.~      The ANI project (ABCR NGS ID) aims at characterizing at the molecular level ABCR in 55~     patients presenting with intellectual disability and/or multiple congenital anomalies~     (ID/MCA) using NGS. The investigators make the hypothesis that ABCR account for the patient~     phenotype, either by gene disruption or position effect, since genomic imbalance would have~     been previously excluded by array-Comparative Genomic Hybridization (CGH).~      The ANI project is a 3-year-long study that will be conducted by a consortium of 21~     partners, including 19 french hospital cytogenetics laboratories, a research team (TIGER),~     and a cellular biotechnology center. Patients will be recruited by each Cytogenetics~     laboratory. ABCR breakpoints will be molecularly characterized by NGS and a first~     bio-informatics analysis. The results will be verified by amplification of junction~     fragments by polymerase Chain Reaction (PCR) followed by Sanger sequencing, allowing the~     localization of breakpoints at the base-pair level. In some complex cases, FISH experiment~     will be necessary to clarify the results. A second bio-informatics analysis will then~     determine breakpoints' characteristics (sequence, repeated elements, gene and regulatory~     elements). Finally, for each breakpoint, gene expression studies will be performed including~     the gene disrupted by the breakpoint and two neighboring genes. All these data, together~     with those already available in the literature and databases will be integrated to determine~     if the gene could account for the patient's phenotype, allowing an appropriate genetic~     counseling.~      This project will identify new candidate genes involved in ID and developmental anomalies.~     It will also contribute to the development and evaluation of NGS as a diagnostic tool for~     ABCR and ID/MCA. It will also allow unraveling mechanisms and functional consequences of~     ABCR, in particular in term of position effect.~      In conclusion, the ANI project will contribute to the improvement of diagnostic management~     and genetic counseling of patients with ID/MCA and ABCR. It will also contribute to the~     understanding of ABCR physiopathology and to the unraveling of pathway involved in~     development and brain function, thus improving genetic counseling for ID/MCA patients in~     general.~   "
46240|NCT02451748|"~     The purpose of the study is to better understand the factors present in the cells of~     inflamed joints of patients with arthritis that may cause rheumatoid arthritis. Knowledge~     gained from this study may lead to new and better therapies for arthritis.~   "
46241|NCT02451735|"~     The purpose of this study is to review and evaluate the effectiveness of new educational~     materials (informational booklet & DVD) that promote participation in genetic counseling~     among breast cancer survivors.~      There are two phases to this study:~      Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the~     effectiveness of the newly developed educational materials~   "
46242|NCT02451722|"~     Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of~     the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes~     versus normal foot wear in diabetic and healthy subjects.~   "
46243|NCT02451709|"~     To determine whether electronic adherence monitoring with feedback and reminder alarms can~     improve adherence and health outcomes in childhood asthma.~   "
46273|NCT02451319|"~     To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm~     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).~   "
46300|NCT02450968|"~     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing~     acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from~     700 m to 3200 m.~   "
46488|NCT02448524|"~     -  To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in~          the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de~          novo);~        -  To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary~          stent system.~   "
46244|NCT02451696|"~     The purpose of this study is to measure if the drug called Everolimus effects mTOR signaling~     (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex~     (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be~     undergoing brain surgery. One group of patients will be treated with Everolimus, and another~     will not. Researchers will determine if there is a difference in mTOR signaling between the~     patients who were treated with Everolimus and those who were not. Previous studies have~     suggested that Everolimus may reduce seizure activity in TSC patients by decreasing mTOR~     signaling. Since patients with FCD may also have excess mTOR signaling brain activity,~     Everolimus may also reduce seizure activity in these patients.~      The drug Everolimus is approved by the Food and Drug Administration to treat specific types~     of breast, pancreatic, and kidney cancer, a kidney tumor called an angiomyolipoma (common in~     patients with TSC), and TSC patients who have a brain tumor called a subependymal giant cell~     astrocytoma (SEGA). However, in this research it is considered to be an investigational~     since it is not approved for reduction in mTOR signaling and a decrease in seizure~     frequency. Researchers believe that Everolimus may be useful in reducing something called~     cortical hyperexcitability, which is the excess brain activity that can contribute to~     seizures.~   "
46245|NCT02451683|"~     The investigator's overall goal is to develop new strategies to enhance the recovery of~     upper-limb function after spinal cord injury (SCI). The investigator proposes to use modern~     electrophysiological methods to enhance the efficacy of residual corticospinal connections.~     Defining the neural basis by which corticospinal volleys generate muscle responses will~     provide crucial information required to maximize residual motor output. The investigator's~     specific goals are to: 1) determine the temporal and spatial organization of corticospinal~     volleys and motor cortical representations of upper-limb muscles after incomplete cervical~     SCI and 2) develop methodologies to promote recovery of function. The investigator's focus~     on reach and grasp movements because of their importance in daily life activities.~   "
46246|NCT02451670|"~     This project will test the ability of an electronic medical record-based clinical decision~     support system to help primary care providers identify, provide more appropriate care for,~     and control Cardiovascular risk factors for patients with Serious Mental Illness.~   "
46247|NCT02451657|"~     The aim of this study is to assess the suitability of selected scales (floor/ceiling~     effects, variability, test-retest reliability) to measure cognitive function in children~     with Down syndrome over 6 months, and to evaluate the influence of covariates such as age,~     gender or language on these neurocognitive scales.~   "
46248|NCT02451644|"~     The study examines the association between the amount of physical activity of the patient,~     ie the number of steps daily / weekly, and the pregnancy rate after embryo transfer.~   "
46249|NCT02451631|"~     A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control~     Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System~     (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus~   "
46250|NCT02451618|"~     For any newborn that exhibits possible seizure activity or has altered mental status of~     unknown etiology, continuous bedside EEG recording is the standard of care to detect~     subclinical seizure activity. The experimental aspect of this study will be the application~     of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a~     continuous bedside recording of brain activity in the same manner as an EEG recording, while~     ideally producing less irritation of newborn skin than conventional EEG electrodes.~   "
46251|NCT02451605|"~     Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve)~     for total replacement knee surgery.~   "
46252|NCT02451592|"~     The purpose of this study is to determine the risk factors for fungemia in a population of~     patients diagnosed with hematologic malignancies and eligible for chemotherapy.~   "
46253|NCT02451579|"~     A double-blind, placebo controlled study conducted at a single study site. Evaluating the~     role of systemic antihistamine therapy in the reduction of adverse effects associated with~     topical 5-aminolevulinic acid photodynamic therapy.~   "
46254|NCT02451566|"~     The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits~     associated with using the Ovation Prime Abdominal Stent Graft System under the least~     invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the~     Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous~     access, no general anesthesia, no ICU admission post procedure, and next day discharge.~   "
46255|NCT02451553|"~     This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when~     given together with capecitabine in treating patients with solid tumors, pancreatic cancer,~     or biliary cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment and has not responded to previous treatment. Afatinib dimaleate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving afatinib dimaleate together with capecitabine may be a better~     treatment for solid tumors, pancreatic cancer, or biliary cancer.~   "
46256|NCT02451540|"~     In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed~     using Functional Respiratory Imaging.~      In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for~     Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy~     and who are prone to dynamics hyperinflation will be included in this study. To indicate the~     susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score~     after the 6-minute walk test (6MWT) above 4.~      The patients will be randomized in such a way that 1 out of 2 patients will receive placebo~     and 1 the active component.~      Image parameters will be assessed and the correlation with lung function and health related~     quality of life will be checked before and after treatment.~   "
46257|NCT02451527|"~     The purpose of this study is to evaluate the pharmacokinetic study of the combination of~     digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to~     provide scientific basis for clinical combination of PEX168 and drugs.This study is also to~     evaluate the safety and tolerability of mono-digoxin or digoxin plus PEX168.~   "
46258|NCT02451514|"~     The purpose of this study is to evaluate persistence of bactericidal antibodies for N.~     meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years~     after primary vaccination in subjects who previously received a 2-dose series of~     MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune~     response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30~     days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a~     2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune~     response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated~     subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days~     after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to~     vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in~     vaccine-naive subjects and subjects who previously received one dose of MenACWY~   "
46259|NCT02451501|"~     To compare deposition in two different positions.~   "
46260|NCT02451488|"~     Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional~     lymph node immunity~   "
46261|NCT02451475|"~     Background: The investigator hypothesized that the combined use of pregabalin and paroxetine~     would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability~     than amitriptyline or venlafaxine.~      Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving~     pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24),~     venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed~     bi-monthly for consequent six months for the changes in the SSS-8, Center for~     Epidemiological Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality,~     fatigue and medication tolerability and adverse effects.~   "
46262|NCT02451462|"~     Patients who undergo bone marrow transplant for different types of cancer are exposed to~     many treatments such as steroids and whole body radiation. These treatments make the~     transplant possible but also make their bones weaker and more prone to fractures which can~     be a source of significant disability and decreased quality of life for cancer survivors.~     Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug~     given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from~     the bone loss caused by the transplant procedures. The investigators are also interested in~     studying the complex interactions of bone, muscle and fat which are greatly affected after~     bone marrow transplant.~   "
46263|NCT02451449|"~     The purpose of this study is to estimate the prevalence of celiac disease in a population of~     men and women newly referred to fertility treatment in Danish public fertility clinics.~   "
46264|NCT02451436|"~     This study aims to assess the effects of a sleep and media intervention on adolescents'~     overall health.~   "
46265|NCT02451423|"~     This is a single arm, open label Phase II study of MPDL3280A, an anti-PD-L1 antibody~     administered as neoadjuvant therapy to subjects with either BCG-refractory non-muscle~     invasive transitional cell carcinoma (TCC) of the bladder, or muscle-invasive TCC~     appropriate for cystectomy and refusing or ineligible for neoadjuvant chemotherapy. Enrolled~     patients will be assigned sequentially to dose levels in cohorts of 6 patients per dose~     level. The starting dose level is 1200mg x 1 dose and will be escalated in subsequent~     cohorts to 1200mg q 3 weeks x 2 doses, and finally 1200mg q 3 weeks x 3 doses to determine~     the impact of increasing number of treatments on the modulated immune response with the~     tumor tissue. Subjects with adverse pathology (pT3/pT4 or N+) will be offered the option of~     adjuvant MPDL3280A for up to 16 cumulative cycles of treatment.~      After all neoadjuvant study therapy is administered, each subject will undergo cystectomy to~     evaluate pathologic response to treatment and for immunologic characterization in the~     resected tissue. Serum and urine will be obtained as well to characterize circulating immune~     responses. After the multi-dose portion of the study has completed accrual two expansion~     cohorts of up to 15 patients each with NMIBC or MIBC will be accrued at the highest dose~     level for further characterization of safety, efficacy, and immunologic analysis. Patients~     with pT3, pT4, or N+ disease at the time of cystectomy and no metastatic disease will be~     offered the option of adjuvant MPDL3280A for up to a total of 16 cumulative cycles. All~     subjects will be followed clinically for up to 2 years to assess for disease recurrence.~   "
46266|NCT02451410|"~     The aim of this study is to design and evaluate an educational and behavioral intervention~     focused on improving nutrition and physical activity habits among preschoolers in Cuenca,~     Ecuador, with the overarching goal of preventing overweight/obesity and promoting the~     formation of healthy nutrition/physical activity habits.~   "
46267|NCT02451397|"~     A large-scale, community-based, cross-sectional study was conducted to evaluate the extent~     to which lifestyle was associated with osteoporosis among the Chinese population by using~     self-reported questionnaire methods.~   "
46268|NCT02451384|"~     Acccording circulating tumor cells to compare the differences of different methods(routine~     method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of~     pancreatic body and tail.~   "
46269|NCT02451371|"~     The purpose of this study is to exploratively evaluate the efficacy and safety of~     transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience~     persistent auditory verbal hallucinations after adequate antipsychotics therapy for over~     three months.~   "
46270|NCT02451358|"~     The aim of the study is to generate immunogenicity and safety data in the whole population~     to support registration of the Quadrivalent Influenza Vaccine (QIV) in India:~      Primary objective:~        -  To describe in each age group the immune response induced by a single injection~          (subjects aged >9 years) or 2 injections (subjects aged 6 months to 8 years) of QIV.~      Secondary objective:~        -  To describe in each age group the safety profile of QIV.~   "
46271|NCT02451345|"~     A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and~     uncertainty, thereby increasing appropriate uptake of active surveillance and reducing~     over-treatment of low-risk prostate cancer.~      This study involves: completion of questionnaires through the secure website; consultation~     by a health coach to aid men with prostate cancer in making informed treatment decision~     (personalized coaching session(s)), bio-specimen collection/analysis.~   "
46298|NCT02450994|"~     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing~     sleep related breathing disturbances in lowlanders with chronic obstructive lung disease~     travelling from 700 m to 3200 m.~   "
46274|NCT02451306|"~     Bipolar disorder (BPD) is often misdiagnosed as unipolar depression. This leads to~     inadequate treatment and can have negative impact on the course of the disease. There is now~     preliminary evidence that patients with unipolar and bipolar depression as well as healthy~     individuals with a heightened risk of BPD can be distinguished from each other based on~     their brain activity patterns and functional connectivity during resting state.~      However, the impact of pharmacological treatment on these functional brain measures have not~     yet been clarified. For common antidepressants it has been shown that they seem to normalise~     aberrant brain activity patterns and functional connectivity. The problem is that some~     antidepressants can induce mania or accelerate pathological cycling in depressive patients~     with unrecognised BPD. Therefore, pharmacological drugs with mood-stabilising properties~     such as quetiapine are more and more prescribed. Although the effectiveness and tolerability~     have been proven, the neuronal effects of these adjunctive treatments are not clear. The aim~     of the study is thus to investigate the impact of quetiapine on measures of brain activity~     in depressive patients with a heightened risk of BPD. Moreover, the investigators want to~     examine whether the investigators can distinguish depressive patients with a heightened risk~     of BPD from depressive patients without a heightened risk of BPD using neuroimaging~     techniques, and whether these measures can predict the course of the disease.~   "
46275|NCT02451293|"~     The objective of the study is to investigate whether prophylactic treatment with melatonin~     has an effect on depressive symptoms. Secondarily melatonin's effect on anxiety, sleep and~     circadian disturbances will be investigated.~      The MEDACIS trial is a randomised, placebo-controlled, double-blinded multicenter trial~     investigating the effect of 25 mg exogenous melatonin (intervention group) against placebo~     (control group) and the study is designed as a parallel group superiority trial.~   "
46276|NCT02451280|"~     The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral~     robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy~     [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility,~     life quality, and motor control strategy in stroke patients.~   "
46277|NCT02451267|"~     The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain.~     The study will be double blind randomized controlled trial . 120 patients with neck pain~     will be recruited for the study and divided into a research group and control group. The~     research group will receive neck exercise program with neck massage and aerobic exercise~     (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise~     program with neck massage. Both intervention will be delivered by physiotherapist over 10~     treatments and will include a home exercise program. In addition, clinical prediction rule~     (CPR) for identifying patients with neck pain who will respond better to an aerobic~     treatment program will be defined.~   "
46278|NCT02451254|"~     Atrial fibrillation confers up to 5-fold increased risk of stroke in the absence of valvular~     heart disease. Although epidemiological studies have linked various clinical and~     echocardiographic risk factors to stroke, the exact mechanism of increased risk of stroke in~     AF remains poorly understood. Previous reports have suggested that loss of effective atrial~     contraction because of AF is associated with thrombogenesis. Microthrombi are most likely to~     form in the left atrial appendage. In contrast, intravascular thrombotic events in patients~     without AF are generally associated with abnormalities of vascular endothelial function~     and/or the coagulation system. On the assumption that more than 90% of all cardiac thrombi~     in patients with AF form in the LA appendage, and the fact that thrombi have been identified~     in 15-20% of patients with AF who have clinical risk factors for ischemic stroke, it has~     been deemed to be our most lethal attachment. Administration of anticoagulant therapy is~     generally thought to be necessary as a preventive measure for patients at high risk of~     thromboembolism, but data indicating inadequate implementation of this highly effective~     therapy]. Several studies have found regional differences in platelet activation and~     hypercoagulability in the LA compared with systemic circulation in patients with valvular~     and nonvalvular AF, suggesting local contributing factors. Animal studies have demonstrated~     increased platelet activation and endothelial dysfunction with acute AF. The ability of~     antiplatelet agents to reduce the risk of cardioembolic events in AF suggests that platelets~     may contribute to the pathophysiology. Platelet activation occurs with AF and rapid atrial~     pacing, providing a possible mechanistic link. Other biomarkers that have proposed to~     improve the prediction of thromboembolotic events in this patient population include von~     Willebrand factor and D-dimer and cerebral imaging. A comprehensive understanding of the~     pathophysiological sequence leading to thrombus formation in the LAA of patients with AF~     could be helpful to characterize those at high risk for thromboembolic events, and~     subsequently to optimize the management of high risk patients.~   "
46279|NCT02451241|"~     Recent evidences from small studies show potential benefit of acupuncture in the treatment~     of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the~     treatment on the cardiovascular system.~      Primary end-point:~      To investigate the effects of acupuncture in improving OSA severity among hypertensive~     patients.~      Secondary end-point To investigate the effect of acupuncture in improving the quality of~     life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh~     Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial~     stiffness~   "
46280|NCT02451228|"~     This study will follow pregnant women who are taking indomethacin for preterm labor to find~     out the pharmacokinetics (what the body does to the drug) and pharmacodynamics~     (effectiveness of the drug in treating the specific intended disease process) of this~     medication. This will help us develop more information for medication dosing specific to~     pregnant women experiencing preterm labor.~      Indomethacin is often prescribed to pregnant women presenting with preterm labor or~     shortened cervix, which places them at risk for preterm labor and delivery. Indomethacin has~     been used since the 1970s to prolong pregnancy by decreasing uterine contractions. However,~     despite the widespread use of indomethacin in pregnancy, there is limited information~     available to help physicians determine how much indomethacin to prescribe and how often to~     prescribe it.~   "
46281|NCT02451215|"~     Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical technique that~     allows for biopsy and thermal ablation of brain tumors. Pediatric patients with brain tumors~     who are eligible and enroll in the trial will undergo LITT at the time of diagnosis or at~     the time of recurrence/progression rather than undergo an open craniotomy and tumor~     resection/biopsy. LITT will include a stereotactic biopsy followed by thermal ablation of~     the tumor. This study will monitor the safety and efficacy of LITT for the treatment of~     pediatric brain tumors.~   "
46282|NCT02451202|"~     It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex~     as an reversal in endolaryngeal surgery.~      We will conduct a clinical study aiming to compare two treatment strategies; Deep~     neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB~     will offer better stillness. We will also descriptively examine if patients would be safely~     discharged from a recovery room.~   "
46283|NCT02451189|"~     Obesity, with its associated co-morbidities, is a major public health challenge. It is~     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is~     associated with increased risk of developing diabetes, cardiovascular disease, and certain~     cancers. The increasing epidemic of obesity has necessitated the study of the complex~     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are~     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of~     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several~     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been~     shown to play an important role in regulating short-term food intake. Peripheral~     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.~     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to~     nutrient availability in different regions of the gut and provide an exquisite mechanism of~     nutrient sensing in response to dietary intake. These hormones therefore represent potential~     targets in the development of novel anti-obesity treatments. A novel and attractive strategy~     to induce appetite regulation is the enrichment of foods with components that stimulate the~     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial~     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY~     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free~     fatty acid receptors (FFAR) on colonic L cells. However, it is not known whether the three~     SCFA, acetate, butyrate and propionate, differentially affect appetite and glucose control.~     The aim of this study is to compare the effects of increased colonic delivery of acetate,~     butyrate and propionate on appetite and glucose control in overweight men in a randomised~     crossover study.~   "
46284|NCT02451176|"~     This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic~     mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of~     clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of~     this study will have a major impact on the field of hernia surgery as it will provide~     objective guide to mesh selection, optimize surgical approaches for complex ventral hernia~     repair, and ultimately significantly improve patient outcomes.~   "
46285|NCT02451163|"~     The aim of the study is to measure the effect of wheat polysaccharides on the occurence of~     common cold (CC) in elderly during a 12-week consumption period.~   "
46286|NCT02451150|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of~     TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.~   "
46287|NCT02451137|"~     Primary Objective:~      Demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets (<8%~     if age 65 years or with defined comorbidities (as listed in Appendix G) or otherwise <7%) at~     6 months without documented symptomatic (BG 70mg/dl) hypoglycemia at any time of day from~     baseline to 6 months in uncontrolled insulin naive patients with type 2 diabetes initiating~     basal insulin therapy in a real world setting.~      Secondary Objectives:~      Compare Toujeo to other commercially available basal insulins at 6 and 12 months after~     initiating insulin therapy in a real world setting in terms of:~        -  Patient persistence with assigned basal insulin therapy~        -  Risk of hypoglycemia including the incidence and rate of documented symptomatic and~          severe hypoglycemia~        -  Changes in HbA1c, fasting plasma glucose, body weight~        -  Differences in patient- and provider- reported outcomes (including Diabetes Treatment~          Satisfaction Questionnaire Status and Change Versions DTSQs and DTSQc), Hypoglycemia~          Patient Questionnaire, and patient and provider reported Global Effectiveness Scale~          (GES)~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other provider visits and healthcare costs.~   "
46288|NCT02451124|"~     This pilot clinical trial studies non-endoscopic brushing of the esophagus using a~     non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a~     condition where the lining of the esophagus has changed or been replaced with abnormal cells~     that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a~     capsule balloon that brushes against the walls of the esophagus to collect esophageal~     samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon~     for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to~     treat.~   "
46289|NCT02451111|"~     Follicular lymphomas FL has been traditionally approached either by an initial watch and~     wait policy in the asymptomatic patient, or with single agent treatments with the purpose of~     maintaining a good quality of life for a prolonged time.The combination of rituximab and~     ibrutinib has been tested in clinical trials and appeared to be well tolerated and active.~     Since ibrutinib seems to achieve better results when administered for prolonged time as~     shown in CLL, the investigators have chosen to compare its combination with rituximab to the~     prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03~     trial.~      The aim of the study is to investigate the efficacy, safety and tolerability of the~     treatment combination of Ibrutinib and Rituximab for patients with advanced follicular~     lymphoma in need of therapy.~   "
46290|NCT02451098|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial~     Design, Phase III Clinical Trial.~   "
46291|NCT02451085|"~     The purpose of the present study is to examine whether an intervention plan based on~     exercise through remote rehabilitation system leads to improvement in characteristics of~     walking and balance among patients after hip replacement surgery compared to the current~     conventional way of exercise among these patients.~   "
46292|NCT02451072|"~     Aim of the present study is to investigate the neuronal correlates of self and of personal~     meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes~     using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.~   "
46293|NCT02451059|"~     This research project is aimed to assess the effectiveness and impact of a pediatric-based~     intervention aimed at reducing low-income families' unmet material needs (food, housing,~     employment, childcare, household heat, education and learning the English language ) on~     child health.~   "
46294|NCT02451046|"~     The primary objective of this study was to evaluate the ability of plasma alpha-GST~     measurements in liver donor (at the time of organ removal) to predict primary dysfunction in~     liver recipient. The secondary objective was to study the relationship between alpha-GST~     levels in the plasma of the liver transplant recipient and early graft function recovery.~   "
46295|NCT02451033|"~     Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications~     including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic~     encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC)~     have poor prognosis and further decreases the survival in these patients. It has been~     believed that cirrhosis is irreversible and that treatment should focus on preventing the~     progression of liver fibrosis/dysfunction and its complications.~      Currently the only effective treatment is liver transplantation, an increasingly limited and~     expensive resource especially in developing countries. Furthermore, transplantation comes~     with a requirement for lifelong immunosuppression, and considerable long-term side effects~     that include chronic renal failure, post-transplant lymphoproliferative disease, and~     cardiovascular complications.~      Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow~     have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for~     patients with end stage liver diseases. It has been shown that in response to acute or~     chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver~     and differentiate into hepatic cells. Animal and human studies suggested that such cells~     might contribute to the regeneration after different kinds of liver injuries . In animal~     models, after liver injury, bone marrow-derived circulating pluripotent cells have been~     reported to participate in liver repopulation with both non-parenchymal cells and~     hepatocytes. This repopulation process, however, seems to be highly dependent on the type of~     liver injury and experimental conditions. Fusion with hematopoietic cells has been~     substantiated as a mechanism by which hepatocytes can regenerate, and studies have~     demonstrated improved liver histology and survival in patients with cirrhosis following~     mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF) .~     Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells~     (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved~     survival in patients with alcoholic hepatitis and acute on chronic liver failure (ACLF) .~     However there is insufficient data on whether G-CSF improves survival and prognosis in~     patients with cirrhosis.~      Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its~     outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone~     (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding~     protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and~     to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has~     shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also~     shown to improve liver regeneration and protein synthesis after hepatectomy in patients of~     HCC with cirrhosis . However there is scarcity of data on clinical impact of long term~     administration of GH therapy in patients of cirrhosis.~   "
46296|NCT02451020|"~     The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at~     3200 m.~   "
46297|NCT02451007|"~     Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on~     the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the~     PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in~     patients with selected solid tumors.~   "
46301|NCT02450955|"~     Objective. To compare the benefits of spinal manipulation combined with massage therapy~     versus massage alone in patients with tension-type headache (TTH) on the frequency,~     intensity and disability caused by headache and on cervical range of motion.~      Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was~     conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the~     treatment group received a manipulative technique followed by massage of the cervical and~     suboccipital region; a) the control group received massage alone. Four sessions (once per~     week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to~     evaluate changes in the frequency and severity of headache and functional and emotional~     aspects of headache. Range of upper cervical and cervical flexion and extension were~     evaluated. Measures were conducted at baseline, immediately after the intervention (week 4)~     and at a follow up 8 weeks after completion of the intervention.~   "
46302|NCT02450942|"~     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed~     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,~     biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and~     patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be~     intravenously injected into healthy volunteers and patients with suspected infection. Visual~     and semiquantitative method will be used to assess the PET/CT images. Changes of blood~     pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine~     aminotransferase, albumin, and creatinine, and any adverse events will be collected from the~     volunteers. Adverse events will also be observed in the patients.~   "
46303|NCT02450929|"~     This protocol is designed to determine if a transition from barrel-shaped cuff designs to~     the Taperguard endotracheal tube (ETT) reduces the incidence of postoperative pneumonia in a~     prospective evaluation of a large general, vascular, orthopedic, urologic and neurologic~     surgical population. The protocol was originally developed as a quality assurance project to~     evaluate a practice change that took place December 1, 2012. Data regarding postoperative~     pneumonia and related factors will be reviewed for the 18 months prior to the practice~     change and compared to data from the 14.5 months following the change. Since the results may~     be of interest to a wider audience, we are converting the project to a research study that~     may be published in the future.~      The study will include data from all adult patients who had surgery at OHSU between June 1,~     2011 and February 15, 2014. We anticipate that we will enroll approximately 40,000 subjects~     (at least 22,000 in the pre-intervention group and at least 16,000 in the post-intervention~     group). Data will be gathered from the OHSU electronic medical record system (Centricity and~     Epic).~      6. A multiple logistic regression analysis will be employed to determine the rates of~     pneumonia between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for~     the defined group of surgical patients. The regression analysis would be adjusted for~     confounding variables including ASA status, age, use of paralytic, RSI with cricoid~     pressure, weight, pre-existing lung disease.~   "
46304|NCT02450916|"~     Objective: In addition to physical discomforts, work-related injuries and illnesses often~     result in various forms of hardships, including economic hardship, labor conflicts and legal~     disputes. The physical and psychological health conditions are likely to be worsen when the~     social supporting systems are not well functioning. In this study, the investigators aim to~     conduct in-depth interviews with injured workers to study their experiences with the social~     systems, including employment protection system, workers' compensation system, health care~     system and other social welfare systems, and to explore how the systems may affect workers'~     physical and psychological health.~      Methods: Face-to-face interviews will be conducted with a semi-structured questionnaire.~     Subjects who had ever experienced work-related injuries or diseases (including muscular~     skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the~     past 3 years are invited. The investigators anticipate to recruit a total of 60~100 cases,~     whom will be recruited through the assistance of occupational physicians, occupational~     health centers, labor groups and unions. Interview time will be limited to 1 hour.~      Anticipated results and contribution: Findings of this study will help to advance our~     knowledge concerning the functions of current social systems and the hardships of workers~     who suffer from work-related injuries and diseases. Suggestions will be provided for the~     improvements of current systems.~      Keywords: work-related injury, occupational disease, workers' compensation, psychological,~     policy.~   "
46305|NCT02450903|"~     This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and~     safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged~     stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd~     will continue until the patient experiences disease progression as determined by the~     investigator according to RECIST 1.1, unacceptable toxicity that precludes further~     treatment, pregnancy, start of a new anticancer therapy, discontinues treatment at the~     discretion of the patient or investigator, lost to follow-up, death, or study is terminated~     by Sponsor.~   "
46306|NCT02450890|"~     The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate~     in children and adolescents with ADHD.~   "
46307|NCT02450877|"~     This study is a randomized, multicenter, open-label, Phase 2 study that will be run in 2~     parts: a safety run-in part to determine the dose of azacitidine and then a second part to~     determine the efficacy of that dose in children and young adults with acute myeloid leukemia~     in molecular relapse after their first complete remission.~      Indication Treatment of children and young adults with molecular relapse of acute myeloid~     leukemia (AML) after first complete remission (CR1).~      Objectives Primary Objectives Safety Run-in Part To establish a safe and tolerable dose of~     azacitidine to be used in the randomized part of the study.~      Randomized Part To evaluate the effect of azacitidine treatment in AML subjects at molecular~     relapse after CR1 when compared to no treatment with regard to the progression-free rate~     (PFR) at Day 84 (±4 days) post randomization.~      Secondary Objectives Safety Run-in Part To establish azacitidine plasma pharmacokinetic (PK)~     parameters in subjects with molecular relapse AML after CR1 and to assess efficacy.~      Randomized Part To evaluate the safety, pharmacodynamics (PD), and efficacy of azacitidine~     treatment in subjects with molecular relapse AML after CR1.~      Study Design The population of this trial consists of children and young adults with AML who~     achieved a complete response (CR) with molecular remission, defined as Minimal Residual~     Disease (MRD) less than 5 x 10-4, following their initial induction therapy and who~     subsequently have a molecular relapse (defined as increase in MRD level by at least 1 log~     [10-fold] to a level greater than or equal to 5 x 10-4 despite a normal percentage [<5%] of~     myeloblasts in the bone marrow [BM] aspirate and peripheral blood [PB], and in the absence~     of proven histological extramedullary relapse). Eligible subjects have a documented~     diagnosis of AML with at least one of the following molecular aberrations t(8;21),~     RUNX1-RUNX1T1, inv(16), CBFb/MYH11, t(9;11), MLL-AF9, NPM1 mutation, or FLT3-ITD mutation.~     Enrolled/randomized pediatric subjects will be followed with regular MRD testing in order to~     detect a molecular relapse.~      In the safety run-in part, up to 12 subjects aged 3 months to less than 18 years will be~     enrolled. Six subjects will be enrolled in the first cohort of 100 mg/m2 azacitidine~     administered intravenously (IV) on Days 1 to 7 of a 28-day cycle. Six additional subjects~     could be enrolled into a second cohort of 75 mg/m2 azacitidine administered IV on Days 1 to~     7 of a 28-day cycle depending on the safety and tolerability results of the 100 mg/m2~     cohort.~      In the randomized part of the study at least 68 subjects will be randomized (or more~     depending on whether at least 64 subjects are evaluable for the primary endpoint), with at~     least 60 of the subjects being less than 18 years of age.~      Both parts of the study, the safety run-in part and the randomized part, will contain 3~     periods: the screening period, the treatment period and the follow-up period. The screening~     period will last no more than 10 days in the safety run-in part after which the subjects may~     be enrolled and treated. In the randomized part, the screening period will last an~     indefinite amount of time until detection of a molecular relapse in the PB followed by~     confirmation of the relapse in both PB and BM aspirate, at which point the subject may then~     be randomized. Subjects will be treated with azacitidine (safety run-in part) or in~     accordance to their assigned treatment arm (randomized part). Upon discontinuation from the~     treatment period, subjects will enter into the follow-up period which will last up to 2~     years from last patient enrolled/randomized.~   "
46308|NCT02450864|"~     Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal~     Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT~     on shoulder stiffness.~   "
46309|NCT02450851|"~     Background:~      - Without an explanation for severe and sometimes life-threatening symptoms, patients and~     their families are left in a state of unknown. The NIH helped create a network of medical~     research centers, called the Undiagnosed Diseases Network (UDN), to provide care and answers~     for these individuals.~      Objectives:~      - To improve diagnosis and care for people with undiagnosed diseases.~      Eligibility:~      - People with undiagnosed diseases, and their relatives.~      Design:~        -  Participants will travel to one of the UDN medical centers for a 5-day clinical and~          research visit.~             -  As part of the visit, UDN healthcare providers may ask participants to have:~                  -  Clinically indicated tests and procedures performed including:~                       -  A physical exam~                       -  Blood and urine tests~                       -  A review of health and family history~                       -  X-rays and body scans~                       -  Surveys~                       -  Photographs of the face and body~                       -  A special diet to see if the body can handle the food without having a~                         reaction, like vomiting~                       -  Video or voice recordings~                       -  Other tests and procedures to help reach a diagnosis~                  -  Research tests and procedures performed including:~                       -  A skin biopsy. For this, a small piece of skin will be taken.~                       -  Surveys~                       -  Other tests and procedures for research that may not be related to a~                         diagnosis or treatment.~        -  Most participants will be asked to give samples for genetic testing.~        -  Participants may be contacted after their visit to discuss test results. They may also~          be contacted in the future for interviews and surveys.~        -  Relatives of participants may be asked to give samples for genetic testing. They may be~          asked to have parts of their visit recorded and to have additional tests. They may also~          be contacted in the future for interviews and surveys.~        -  Clinical and research information collected will be stored in a database.~        -  Information and samples collected will be shared with others for research purposes.~   "
46310|NCT02450838|"~     Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of~     people throughout the tropics and subtropics. This study will evaluate the safety,~     tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180)~     in healthy adults who previously received a live-attenuated tetravalent dengue vaccine~     (TV003 or TV005).~   "
46311|NCT02450825|"~     This study is designed to compare three ultrasound-based aeration scores that were~     previously validated in specific populations, and to assess their correlation with computed~     tomographic measurement of pulmonary aeration in a population with different pathologies.~      Hypothesis: The Loss of Aeration Score will be more accurate than a simplified version and~     another widely used score, the Lung Ultrasound Score.~   "
46312|NCT02450812|"~     This observational prospective single arm cohort study is designed to assess overall~     survival, symptomatic skeletal event free survival and quality of life of of chemotherapy~     naïve metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223~     under real life conditions. In addition, time to next tumor treatment (TTNT), mobility,~     quality of life and selfcare, independence in activities of daily living and safety will be~     assessed.~   "
46313|NCT02450799|"~     The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL~     to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will~     take place in Japan.~   "
46314|NCT02450786|"~     There have been growing interest in identifying Parkinson's disease (PD) patients with mild~     cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is~     known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels,~     in which suggest the existence of something common with Alzheimer's dementia. PDD have~     showed more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The~     investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves~     cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with~     cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in~     DLB and PDD. This supports the hypothesis that the two disorders are closely related~     clinically and neurobiologically. Larger scale, placebo controlled clinical trials are~     needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in~     Lewy body disease.~      It is believed that earlier intervention, later appearance of dementia should be needed to~     lower the socioeconomic costs and to improve the quality of life on patients and caregivers.~     The investigators anticipate that donepezil may delay the development of dementia in~     patients with PD-MCI.~   "
46315|NCT02450773|"~     The purpose of this study is to determine whether postpartum administration of furosemide to~     women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or~     elevated blood pressure in the first 24 hours following delivery reduces severe postpartum~     hypertension.~   "
46316|NCT02450760|"~     The goal of this pilot project is to assess adherence with home blood pressure monitoring in~     hypertensive patients with a history of cerebral infarction and to determine if a social~     incentive improves adherence with monitoring. Enrolled subjects will all have a history of~     cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at~     the time of enrollment. To be eligible subjects will also be required to own a smart phone~     (iOS or Android operating system). After enrollment, patients will be given a home blood~     pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will~     be randomly assigned to a social incentive program, in which a social supporter receives~     updates via email and/or text message on the subject's adherence with BP monitoring and~     their average blood pressure. This study will provide important pilot data which will inform~     the design of future studies utilizing connected health and automated systems to improve~     home blood pressure monitoring and blood pressure control in patients with a history of~     stroke.~   "
46317|NCT02450747|"~     This is a four week study to evaluate the performance of a multifocal contact lens in~     habitual wearers of silicone hydrogel multifocal contact lenses.~   "
46318|NCT02450734|"~     Since stroke and myocardial ischemia are major causes of perioperative morbidity and~     mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best~     hemodynamic stability are important goals of perioperative management.~      The investigators conducted a prospective observational study about efficacy and safety of~     the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate~     postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid~     endarterectomy.~   "
46319|NCT02450721|"~     Aim of the present study is to investigate molecular and clinical markers in patients with~     atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.~   "
46320|NCT02450708|"~     This study tests whether adding certain genetic factors to the process of picking a stem~     cell donor can decrease the chances that the patient's leukemia will come back after bone~     marrow transplantation. Stem cell donors are matched based on genes called human leukocyte~     antigens (HLA).~      Currently, donors are selected largely on the basis of HLA gene typing alone. There is~     published data to show that donors with specific other genes called killer~     immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia~     return after a transplant. In this study, the best HLA matched donors will be tested for the~     KIR genes. If there are more than one donor available, a recommendation will be provided to~     study doctors as to which donors have potentially favorable KIR genes. The study doctors may~     or may not choose to use this donor for transplant or not based on his/her own judgment.~     Transplant care will not change otherwise as a result of this study.~      This study is being done to demonstrate that AML patients who have donors with specific KIR~     and HLA genes will have a better outcome following transplant.~   "
46321|NCT02450695|"~     This study will evaluate the effectiveness of rTMS as a potential treatment for refractory~     OCD in a randomized, crossover design.~   "
46322|NCT02450682|"~     This study is being done to determine if apixaban is more safe, when compared to warfarin,~     at reducing the risk of bleeding during CIED procedures.~   "
46323|NCT02450669|"~     Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio~     of extubation has to be daily assessed in intubated patients.~      The investigators aimed to assess incidence and risk factors of airway failure after~     extubation procedure in critically ill patients in a prospective multicenter study.~   "
46324|NCT02450656|"~     This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a~     phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in~     combination with selumetinib; and PART B - a randomized phase II study investigating the~     progression free survival and safety of selumetinib/afatinib combination therapy compared to~     standard of care chemotherapy.~   "
46325|NCT02450643|"~     Infants/children with cow's milk allergy will take part in 2 double-blinded~     placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random~     order. If both food challenges are passed, subjects will be asked to consume the Test~     formula in an at-home open challenge for 7 days.~   "
46326|NCT02450630|"~     Uganda's under-five mortality is high, currently estimated at 90/1000 live births (Uganda~     Bureau of Statistics 2011). Poor referral of sick children that seek care from the private~     sector is one of the contributory factors. The proposed intervention aims to improve uptake~     of referral advice for children that seek care from private facilities (registered drug~     shops/private clinics).~      The project will be implemented in Mukono district, central Uganda selected because a recent~     concluded trial in the district showed that drug shop vendors (DSVs) adhere to diagnostic~     test results, treat appropriately and refer sick children; although uptake of referral is~     poor. The main reasons attributed to the observed poor referral were negative attitude~     towards referral forms from drugs shops by the health workers at referral~     facilities,perceptions of poor quality of care at referral facilities and costs involved~     (Hutchinson. 2012; Hutchinson et al. 2013 in press)..~      Thus the proposed project is a follow up to address these factors with the aim to improve~     uptake of referral. This project is in line with the Uganda's Health sector and USAID~     Mission's health priorities of strengthening the health system. Critical barriers in the~     implementation of child survival interventions are poor quality of care in the private~     sector and timely referral and uptake of referral advice at community level. These barriers~     may be attributed to inadequate training of providers in the private sector (in diagnosis~     and management of childhood illnesses); inadequate supervision and regulation; poor linkages~     and collaboration between the public and private sectors; and non-existent linkages between~     community structures and the private sector. The barriers will be addressed through an~     intervention with three components; i) VHTs will be trained to do community sensitization~     and initiate community discussions aimed at identifying community support mechanisms for~     financial hardship (to be community led and managed) - e.g. communities to be encouraged to~     establish community credit/insurance schemes for referral VHTs will register children and~     facilitate follow up of sick children ii) supervision of providers in the private sector to~     diagnose, treat and refer sick children, iii) regular meetings between the public and~     private providers (convened by the district health team) to discuss the referral system.~   "
46327|NCT02450617|"~     The research project outlined in this proposal aims to investigate the effectiveness of~     stabilizing group treatment as an add-on to conventional treatment, for patients with Post~     Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The~     investigators also aim to study psychophysiological markers associated with complex trauma~     and treatment, mechanisms of change involved in treatment, and which patient characteristics~     that predict positive outcome.~   "
46328|NCT02450604|"~     Fabry disease is a rare inherited metabolic disorder that predominantly affects heart,~     kidneys and nervous system. Fabry disease has been searched in series of patients presenting~     different isolated signs caused by the affection of one of these organs. Acroparesthesias~     and chronic crises of pain of different origins are reported in the large majority of~     patients during the progression of the disease. Moreover, this signs are frequently~     inaugurating the disease. The investigators have previously performed a preliminary~     single-center study which permitted to identify one female patient with Fabry disease in a~     series of 147 consecutive patients with chronic pain tested. The investigators now propose~     to confirm the results of our preliminary study. The investigators plan to evaluate the~     prevalence of Fabry disease in a series of 1000 patients suffering from chronic pains of~     undetermined aetiology and consecutively recruited.~   "
46329|NCT02450591|"~     This study will test if local therapies in addition to erlotinib can improve responses and~     delay the time until new treatment is required. This study will also collect blood samples~     for research blood tests.~   "
46330|NCT02450578|"~     Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and~     validated Human Challenge model using direct venous inoculation of aseptic, purified,~     cryopreserved, vialed Plasmodium falciparum sporozoites.~   "
46331|NCT02450565|"~     Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease~     on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is~     often underdiagnosed and undertreated. As treatment is different for patients with~     neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain.~     Commonly employed questionnaire-based diagnostic tools in English speaking countries include~     the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic~     pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not~     restricted to clinician's examination and can be applied in large-scale research. S-LANSS~     has been successfully translated, validated and used successfully in Arabic and Turkish, but~     it has not been utilised in the Chinese population. As verbal translations of the English~     questionnaires used at the bedside may be prone to errors in interpretation and requires~     medical practitioners to interpret the questions. Therefore a translation and validation~     study is essential.~   "
46332|NCT02450552|"~     This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor~     neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration~     is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.~   "
46333|NCT02450539|"~     The main purpose of this study is to evaluate the effectiveness of the study drug known as~     abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung~     cancer (NSCLC) previously treated with platinum-based chemotherapy.~   "
46334|NCT02450526|"~     The objective of this study is to demonstrate the efficacy of Dysport for the improvement in~     appearance of moderate to severe glabellar lines and to assess the short term and long term~     safety of Dysport, used for the improvement in appearance of moderate to severe glabellar~     lines in Chinese subjects.~   "
46335|NCT02450513|"~     Observational pharmacokinetics study of adalimumab in patients with active refractory~     Crohn's disease who are naïve to TNF antagonist therapy.~   "
46353|NCT02450279|"~     Many devices are available for nebulising drug solution during invasive mechanical~     ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent~     international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013)~     reported that jet nebulizers remained the mostly used.~      The aim of this study is to compare lung deposition of a radiolabeled administered with both~     nebulizers during invasive mechanical ventilation by planar scintigraphy.~   "
46489|NCT02448511|"~     This study evaluates the efficacy of local application of ozone gas in healing of infected~     ulcers. Half the participants received conventional treatment with placebo generator and the~     other half received conventional treatment with ozone generator.~   "
46336|NCT02450500|"~     More than a third of the adult population in England have prediabetes, a condition that~     occurs when glucose levels are higher than normal but not high enough to be diagnosed as~     diabetes. Between 5 and 10% of people with prediabetes will go on to develop diabetes each~     year. Lifestyle (diet and activity) interventions have been shown to reduce the risk of~     prediabetes progressing to Type 2 diabetes. However, in practice high levels of professional~     support coupled with increasing incidence of prediabetes are not sustainable in their~     current format. The internet has the potential to provide an alternative means of supporting~     large numbers of individuals in making lifestyle changes. However, provision of information~     on its own is not enough to engage individuals to change - additional support via~     personalised feedback is required to sustain the level of motivation needed for long term~     behaviour change.~      AIM: The investigators hypothesis is that communicating with individuals at high risk of~     Type 2 diabetes via a web-based lifestyle app will lead to changes in lifestyle behaviours~     resulting in an improved glycaemic control and reduction in diabetes risk.~      METHOD: The study will be conducted over 6 months. Patients identified in GP practice who~     are at high risk of developing diabetes will be invited to take part in this feasibility~     study.~      Intervention (6 months): This will consist of a web-based lifestyle app and personalised~     behaviour modification advice delivered via messaging by a dietitian. Participants will also~     be issued with a pedometer. Data on the dietary intake and activity levels will be collected~     on the web-based lifestyle app. Contact between the dietitian and participants will consist~     of weekly messaging to facilitate changes in diet and activity behaviour through~     motivational and cognitive behavioural strategies.~      Blood biochemistry (HbA1c, FBG, LFT's and lipids), BP, weight, BMI, and waist circumference~     will be measured at 0, 3 and 6 months. The blood test will be taken by a practice nurse at~     the GP practices and sent off for analysis. A 5 day food diary, well-being and activity~     questionnaires will be collected at 0, 3 and 6 months by the researcher.~      At the end of the intervention period, participants will be invited to attend a focus group~     to assess participants' perceptions/ease of use and barriers to use of the technology~     employed to assist behaviour change~   "
46337|NCT02450487|"~     Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors~     to individual responses to drugs. This branch of science involves the variability in~     pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding~     receptors, as well as in drug metabolism, where this area of Pharmacology has been growing~     and achieving its first results with clinical use. The non-steroidal anti-inflammatory~     (NSAIDS) are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of~     this study is to evaluate the different gene haplotypes for the clinical efficacy of~     piroxicam after third lower molar surgery for pain, edema and trismus, adverse reactions,~     need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics~     of the drug between the different gene haplotypes for CYP2C9 that are found in this~     population. Therefore, 60 patients will be genotyped and phenotyped for this gene and their~     postoperative data will be confronted with the data found in the Brazilian population. For~     the analysis of the proposed gene, saliva will be collected and serve as a source of genomic~     DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and~     produced by Applied Biosystems® will be performed. For the pharmacokinetics, saliva samples~     will be collected at various times according to protocols available in the literature, and~     piroxicam concentrations in the samples will be measured by high pressure liquid~     chromatography (HPLC) and Liquid chromatography-mass spectrometry (LC MS/MS). The analysis~     of the results will be described with a significance level of 0.05.~   "
46338|NCT02450474|"~     Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid~     management is associated with the increased risk. One of the principal limitations in~     avoiding chronic fluid overload in this patient group is the refilling rate the rate at~     which fluid is transferred from tissues into the vascular system. If this rate cannot match~     the prescribed rate of fluid removal during dialysis the patient will end up with chronic~     fluid overload.~      Two proposed methods of increasing the rate of refilling are intermittent pneumatic~     compression (IPC) devices, which increase the pressure of the fluid in tissue, and~     neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic~     drainage.~      This investigation will trial the use of these two methods in patients suspected of having~     inadequate refilling rates. Outcome measures will be based on fluid status, presence of~     oedema and quality of life.~   "
46339|NCT02450461|"~     The purpose of this study is to answer the question whether a disease-specific profile of~     breath in patients with asthma can be detected by an untargeted metabolomic study using~     exhaled breath analysis by mass spectrometry.~   "
46340|NCT02450448|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     renal cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
46341|NCT02450435|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     prostatic cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
46342|NCT02450422|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     colorectal cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
46343|NCT02450409|"~     Beside the current standard of classical mechanical alignment of total knee replacements,~     increased interest is being shown in anatomical alignment. However, no surgical technique is~     capable of controlling the stability of the joint in midflexion. The purpose of the present~     study was to present and evaluate a new surgical technique, which aims to reduce the need~     for soft-tissue release and optimize stability in midflexion.~   "
46344|NCT02450396|"~     Rare diseases frequently affect women of childbearing age. Pregnancy in these women has~     become less rare, but remains associated with high levels of complications. One obstacle to~     their optimal management during pregnancy is that there are no prospective studies of~     pregnancy during rare diseases and several connective tissue diseases. As a consequence, the~     management of these pregnancies is non-standardised in terms of treatment, monitoring~     (frequency of consultations, laboratory tests and ultrasound), and organisation of care.~      Moreover, although these women (all diseases combined) are frequently exposed to medications~     potentially incompatible with pregnancy, little is known about the frequency of these~     exposures and especially their consequences to mother and child.~      For these reasons, researchers and clinicians from different specialties created an~     interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve~     the management of these patients' pregnancies. Using a single computer server, the~     investigators plan to set up a large prospective study of pregnancies in patients with rare~     diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome,~     scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse~     the complications of pregnancies in women with rare diseases and then to improve their~     management and their quality of life.~   "
46345|NCT02450383|"~     The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular~     dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an~     autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.~      AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for~     transplantation. AlloDerm is processed and marketed in accordance with the FDA's~     requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for~     Tissue Banking of the American Association of Tissue Banks (AATB).~      20 adult subjects will be recruited who are in need of dental implant placement with~     simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the~     subjects will be randomized to the ADM group and half will be randomized to the sCTG group.~     The surgical intervention will be performed according to the protocol and subjects will~     return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of~     healing, gum thickness, subject perception of pain, and esthetic photographs.~   "
46346|NCT02450370|"~     Subjects with confirmed diagnosis of Irritable Bowel Syndrome will be blinded and randomly~     assigned to one of two groups, the low FODMAP diet or the conventional IBS diet group. They~     will be referred to do three hydrogen breath tests prior to diet education. Upon completion,~     subjects will attend dietitian consultations at Week 0, 6 and 10 for diet assessment,~     education and reinforcement. At Week 4 and 8, dietitians will telephone patients to check on~     diet compliance and answer any diet question. Two sets of questionnaires, the IBS Global~     Improvement Scale and the IBSQOL will be given to patients to complete before each dietitian~     visit at week 0, 6 and 10. Two sample t-test and Chi square test will be used to test the~     difference between the two groups and the association between breath tests results and~     responds to the two diets.~   "
46347|NCT02450357|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     breast cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
46348|NCT02450344|"~     Objectives The aims of this study are to test the effectiveness of an online quiz~     competition in changing adolescents' alcohol-related attitudes and behaviour and to explore~     the fe¬asibility of using Internet viral marketing to reach a significant number of~     adolescents.~      Hypotheses to be tested~        1. The present online quiz competition is more effective in changing adolescents'~          alcohol-related attitudes and behaviours than traditional health promotion.~        2. Internet viral marketing is effective in reaching a significant number of adolescents.~      Design and subjects The study will constitute a cluster randomised controlled trial for 20~     secondary schools (6,720 Grade 7 to 9 students). Schools will be randomised to intervention~     or control arm with equal likelihood. Students in intervention schools will be invited to~     take part in the Internet campaign whereas those in control schools will receive relevant~     promotional leaflets.~      Study instrument An alcohol attitude and behaviour survey will be compiled with reference to~     standardised, validated instruments.~      Intervention Participants will log into the website and answer alcohol-related~     multiple-choice questions. They will be encouraged to promulgate the campaign to others.~      Main outcome measures Alcohol-related attitude and behaviour will be the primary outcome~     measures.~      Data analysis Multilevel regressions will mainly be used to evaluate the difference in~     attitude and behaviour.~      Expected results The results of the proposed study will provide evidence on the efficacy of~     an Internet intervention in modifying adolescents' attitudes and behaviour and guide further~     investigation into the prevention of and intervention in such risk behaviours as underage~     drinking.~   "
46349|NCT02450331|"~     This study is to evaluate the efficacy and safety of adjuvant treatment with Atezolizumab~     compared with observation in participants with PD-L1-selected muscle-invasive bladder cancer~     (MIBC) who are at high risk for recurrence following cystectomy.~   "
46350|NCT02450318|"~     The purpose of this study is to examine the acute effect of exercise on vascular function in~     women with nonobstructive coronary artery disease.~   "
46351|NCT02450305|"~     The investigators intend to determine if patients that are already undergoing Hyperbaric~     Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck~     cancer, experience improvement in xerostomia and/or taste alteration. The investigators will~     enroll a similar demographic one year post treatment with radiation therapy that does not~     receive HBO therapy. This is a quality of life study.~   "
46352|NCT02450292|"~     The purpose of this study is to examine the long-term appearance and resorption rate of~     biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).~   "
46377|NCT02449967|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction Angiography（DSA）for pancreatic cancer.~   "
46354|NCT02450266|"~     Patients will be submitted to a multiparametric MRI examination of the prostate.~     Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A~     patients will be submitted to the gold-standard which comprises systematic transrectal~     ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted~     prostate biopsy based on the multiparametric MRI findings.~   "
46355|NCT02450253|"~     Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive~     function in patients with cerebral small vessel disease~   "
46356|NCT02450240|"~     In this study the investigators will seek to improve our understanding of how positive and~     negative valence systems, cognition, and arousal/interoception are inter-related in~     disorders of mood, substance use, and eating behavior. The investigators will recruit 1000~     individuals and use a wide range of assessment tools, neuroimaging measures, blood and~     microbiome collections and behavioral tasks to complete the baseline and follow-up study~     visits. Upon completion, the investigators aim to have robust and reliable dimensional~     measures that quantify these systems and a set of assessments that should be recommended as~     a clinical tool to enhance outcome prediction for the clinician and assist in determining~     who will likely benefit from what type of intervention.~   "
46357|NCT02450227|"~     Absorption and metabolism of carotenoids from two types of spinach preparations will be~     investigated in two study groups, short bowel/ileostomy and healthy, respectively.~      The study will be conducted as a randomised, controlled, 2-way crossover study in 24~     participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions~     with a more and a less bio-accessible spinach preparation. The serum, chylomicron and~     fecal/effluent levels of lutein and beta-carotene will be determined.~   "
46358|NCT02450214|"~     Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The~     management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs)~     are insufficient, while opioids are avoided by their adverse effects and regional techniques~     are hampered by a premature discharge. In this context, the investigators seek an~     intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus~     magnesium to significantly decrease postoperative pain.~   "
46359|NCT02450201|"~     This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the~     acquisition of magnetic resonance (MR) data and will be performed in men with localized~     prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR~     imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five~     patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months~     of ADT.~      13C HP MR data will be acquired in two parts of the study (which can occur simultaneously):~     Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks~     later (with no intervention in the interim) to evaluate reproducibility.~      Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy,~     and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the~     imaging to reflect a metabolic response to treatment.~      The change in pyruvate/lactate ratio and lactate levels will be measured and compared to~     baseline at these timepoints.~   "
46360|NCT02450188|"~     The aim of the present study is to evaluate the efficacy of a combined approach with~     Vardenafil orodispersible and Cognitive Behavioural Sex Therapy in the treatment of Erectile~     Dysfunction, compared to medical only treatment, in terms of quality and duration of~     erection and couple's sexual satisfaction.~   "
46361|NCT02450175|"~     The purpose of this research study is to understand if platelets in the blood become more~     active during cancer and specially advanced stages of cancer, in the future the~     investigators want to see if reducing platelet activity can improve survival in advanced~     cancer.~   "
46362|NCT02450162|"~     -  Background and study aims : The investigators conducted this study to compare the~          movement of extraocular muscle after two types of recession surgery with non-invasive~          tool called AS-OCT.~        -  Who can participate? patients who will undergo two types (conventional method and~          hang-back method) of typical bilateral lateral rectus recession surgery for correcting~          intermittent exotropia~        -  What does the study involve? Volunteers will attend a clinic for four visits over three~          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is~          non-invasive test to evaluate operation site. The test only requires their cooperation~          when they undergo AS-OCT.~        -  What are the possible benefits and risks of participating? This is non-invasive test~          for your postoperative follow up. Therefore, there will be no risks about this test.~        -  Where is the study run from? Samsung Medical Center~        -  When is the study starting and how long is it expected to run for? From April 2015 to~          Dec 2015~   "
46363|NCT02450149|"~     This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.~      This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid~     Tumors harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for~     28 days.~      To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring~     BRAF Mutation.~   "
46364|NCT02450136|"~     This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation~     Refractory solid tumors.~      This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid~     tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered~     orally once a day 28 days.Study treatment will be continued until objective disease~     progression.~      To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring~     FGFR2 Amplification or FGFR2 mutation.~   "
46365|NCT02450123|"~     This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2~     Amplification Refractory solid tumors.~      This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid~     tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be~     administered orally once a day 42 days.Study treatment will be continued until objective~     disease progression.~      To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring~     RET fusion positive or FGFR2 Amplification.~   "
46366|NCT02450110|"~     A randomized pilot study of spinal cord stimulation in patients with chronic heart failure~     aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.~   "
46378|NCT02449954|"~     Comparison between the effects of intravenous morphine, tramadol and ketorolac on stress and~     immune responses in patients undergoing modified radical mastectomy~   "
46367|NCT02450097|"~     The aim of the present study is to investigate in subjects with and without type 2 diabetes~     the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week~     two days caloric fasting with 500 calories for women and 600 calories for men and five days~     of normal caloric intake) on risk markers for cardiovascular disease and certain cancers~     (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood~     lipids, markers of inflammation and oxidative stress) and on peptides regulating glucose~     metabolism and appetite as well as the effect on blood pressure, body composition, waist-~     and hip- circumference. DNA will also be analysed at the start and after 6 months to~     investigate any epigenetic effects.~      After completed study there will be a follow up after additional 6 months.~   "
46368|NCT02450084|"~     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative~     analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is~     accompanied by significant postoperative pain and usually IV-PCA is used to manage the~     pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided~     RSB to single-port robotic gynecologic surgery which has incision site at umbilical area.~     Patients will randomly assigned to two groups, RSB group and Control group. Each patients~     will assessed for time to first rescue analgesia, verbal numerical rating pain scores,~     number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded~     investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.~   "
46369|NCT02450071|"~     Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A~     recent Danish multicentre single country study demonstrated a 99,7% incidence of successful~     anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication~     rate of 7.9%. A London study revealed a significantly higher intubation failure rate among~     non-anaesthesiologist physicians. In Scandinavia different types of emergency medical~     services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal~     intubation (PHETI), incidence of difficult intubation and complications in the Nordic~     countries is not known. The aim of this study is to define PHAAM success rate and~     complications in different types of Nordic EMS organisations and physician critical care~     teams. The study is a prospective observational study with collection of PHAAM data~     according to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS~     centres and physician critical care teams. The primary endpoint is PHETI success on ≤2~     attempts and no complications.~   "
46370|NCT02450058|"~     In this multicenter, randomized phase III trial, node positive early breast cancer patients~     are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2,~     epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles~     of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The~     primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and~     event free survival (EFS).~   "
46371|NCT02450045|"~     Hip fractures (broken hips) are common in older people, particularly older women with~     fragile bones, and usually occur with a simple fall from a standing height. In Canada, over~     28,000 hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip~     fracture, up to 50% of those who survive their hip fracture do not recover to the same level~     of activity that they had before breaking their hip. Managing pain with any broken bone is~     very important. For patients with hip fracture, their older age and fragile health makes~     pain management even more challenging. Many patients with a hip fracture have reduced~     ability to think clearly before the fracture. Some patients who have no difficulty with~     thinking before their hip fracture will become confused for a brief period after their hip~     fracture or can develop permanent difficulties with thinking. A hip fracture will usually~     require an operation, and choosing the right pain medication before and after the operation~     is important since many pain medications make confusion more likely. Permanent difficulty~     with thinking is a common reason for poor recovery after hip fracture. Our study will look~     at use of a nerve block to manage pain before patients have their operation. A nerve block~     provides local pain relief without requiring patients to take the medication by mouth (oral)~     or through an intravenous (IV) route. A nerve block before surgery may reduce the amount of~     oral and IV pain medication needed by the patient both before and after their operation but~     still provide good pain control with less confusion. This could lead to better recovery and~     allow more patients to return to living in the community rather than long-term care.~   "
46372|NCT02450032|"~     This study was designed to investigate the antibody response generated by a 500µg dose of~     G17DT in patients with gastric cancer.~   "
46373|NCT02450019|"~     The purpose of this study is to assess the effect size and variability of dural tension~     measured as intracranial pressure (ICP) below the dura of the surgical field in patients~     undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively~     ventilated with traditional high-volume-no-PEEP ventilation and protective~     low-volume-low-PEEP ventilation.~   "
46374|NCT02450006|"~     To collect biological samples, clinical information and laboratory data from patients~     diagnosed with any healthcare-related conditions who are seen at facilities affiliated with~     Intermountain Healthcare, including patients and their family members, and to collect the~     same information and samples from a general population including disease-free subjects.~   "
46375|NCT02449993|"~     This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of~     breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for~     expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with~     MammaTyper™.~      According to the determined values for the individual parameters at least 4 subtypes can be~     distinguished to date~        -  Luminal A-type~        -  Luminal B-type~        -  HER2-type~        -  Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with~          Immunohistochemical methods will be evaluated.~      As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall~     survival (OS) will be reevaluated according to the new subtyping.~   "
46376|NCT02449980|"~     The purpose of this study is to compare the outcomes between delayed surgery and immediate~     surgery in children who have spontaneous pneumothorax (collapse of the lung). Currently,~     both methods to treat spontaneous pneumothorax has been used but there is no clear evidence~     that one option is better, which is the reason for the investigators current study. The~     investigators hypothesize that immediate surgery will have better outcomes with lower~     recurrence rates than delayed surgery.~   "
46382|NCT02449902|"~     The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating~     moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of~     treatment, and to estimate the effect size and variability of vulvovaginal atrophy~     endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of~     TX-12-004-HR was to be investigated.~   "
46383|NCT02449889|"~     This trial is investigating the efficacy and safety of highly purified human chorionic~     gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of~     final follicular maturation in women undergoing controlled ovarian stimulation~   "
46384|NCT02449876|"~     This is a pilot study to determine if neuroscience education is acceptable to adults over 65~     and if it can have an impact on pain, pain beliefs and gait speed~   "
46385|NCT02449863|"~     Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung~     ultrasound is a useful diagnostic tool that is quick, requires little training and is~     radiation free. This study analyzes whether early lung ultrasound can predict respiratory~     failure.~   "
46386|NCT02449850|"~     The primary objective is of the PreventADALL study is to test if primary prevention of~     allergic diseases is possible by simple and low cost strategies, and secondary to asses the~     impact of xenobiotic exposure and microbiota in and on the body and the environment on~     allergic disease development.~      The secondary objective is to investigate early life risk factors for development of asthma~     and allergic diseases as well as for diseases that may share common risk factors, including~     cardiovascular disease, obesity and diabetes.~      Design: A multi-national population-based prospective birth cohort with a factorial designed~     randomized controlled intervention trial of two clinical interventions; skin care 0-9 months~     and early food introduction by 3-4 months, thereafter observation only.~      Recruitment in three cities (Oslo, Østfold and Stockholm) of approximately 2500 babies is~     done in two steps; first pregnant women are recruited and enrolled at the 18-weeks~     ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are~     included.~      Randomisation into four groups is done by the postal code or bydeler to ensure all four~     intervention-groups within each bydel.~      Visits for biological and environmental sampling, observations and investigations will be at~     the relevant paediatric departments (at 3-6-12-24 months of age) and annually thereafter. It~     is a hope that the study can be maintained well into adulthood.~   "
46387|NCT02449837|"~     The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in~     cancer patients before and after undergoing treatment regimens where the primary treatment~     modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs~     pre- and post- XRT, both in absolute and relative terms.~   "
46388|NCT02449824|"~     Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a~     standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in~     those patients who go on to respond to treatment. Importantly, the investigators will also~     show that blood flow does not decrease in those patients who fail to respond.~      Secondly, the investigators will test whether the decrease in tumour blood flow over the~     whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at~     the time of surgery.~   "
46389|NCT02449811|"~     Randomized, open-label, parallel-group study conducted at a single center in Switzerland.~      Patients diagnosed with primary arterial hypertension requiring antihypertensive drug~     Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be~     recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to~     either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium~     channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current~     guidelines issued by the European Society of Hypertension. Treatment-naive patients will be~     started on an intermediate dose monotherapy (treatment period 1). In all patients who do not~     reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled~     (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles,~     measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will~     be done. A control group with 20 age and gender matched, healthy and normotensive subjects~     will be recruited to establish the characteristics of the RAS peptide profiles in a~     comparable but normotensive population.~   "
46390|NCT02449798|"~     Study objective is to evaluate user preference, time for procedure, insertion success rates,~     complications, completion of therapy and dwell time of the AccuCath 2.25 BC device placed~     in difficult IV access patients in the emergency department.~   "
46391|NCT02449785|"~     Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic~     fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the~     lung morphological changes in cystic fibrosis adults but it remains a radiation-based~     technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing~     alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis~     lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.~   "
46392|NCT02449772|"~     Retrospective study of adult patients (> 16 y) admitted to Geneva University Hospitals with~     alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow~     in the ED will be described.~   "
46393|NCT02449759|"~     This study aims to evaluate the effectiveness of a guided self-help intervention using~     Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help~     manual whilst on a waiting list for individual therapy, while the other half will remain on~     a waiting list and not receive the manual. This study is looking specifically at individuals~     with mild to moderate anxiety and/or depression.~   "
46419|NCT02449421|"~     The purpose of the study is to compare the impact of two strategies to sustain and improve~     the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT)~     in three different mental health systems. These approaches are based on two different~     theories of what is necessary to promote successful implementation. We will examine whether~     these strategies lead to improved patient outcomes, clinician skill, proportion of clients~     who receive CPT, and other outcomes that are relevant to the implementation of~     evidence-based psychosocial treatments. By examining these questions in 3 different mental~     health systems, we will also examine whether the implementation strategies yield different~     results in different systems.~   "
46394|NCT02449746|"~     Psychosis is a mental health problem that causes people to perceive or interpret things~     differently from those around them, often involving hallucinations or delusions. Psychosis~     and schizophrenia are common disorders which predominantly affect younger adults. Recently,~     the investigators discovered that 5-10% of people with psychosis have antibodies in the~     blood that are capable of targeting the surface of brain cells, specific to the~     N-methyl-D-aspartate (NMDA) receptor or voltage gated potassium channel complex, which the~     investigators believe may be causing the problem. Those positive for antibodies may have a~     problem with their immune system and this may prevent their brain from working normally.~     This trial aims to test the feasibility of removing or reducing the antibodies in patients'~     blood, using immunotherapy, and see if this improves symptoms of psychosis. Immunotherapy in~     this feasibility study will involve giving all patients steroid tablets and half of them~     will also receive a drug called intravenous immunoglobulin whereas the other half will~     have a procedure called plasma exchange. The feasibility study is designed to identify~     which method of immunotherapy is most suitable for use in this patient population.~      Results from this will inform on the methodology used for a proposed larger randomised~     control trial.~   "
46395|NCT02449733|"~     The purpose of this study is to evaluate the acceptability and uptake of a combination~     package of biomedical, behavioral and community-level HIV prevention interventions and~     services for men who have sex with men (MSM) in South Africa.~   "
46396|NCT02449720|"~     This study will evaluate the addition of a local anaesthetic infusion into the abdomen to~     patient controlled analgesia in the management of postoperative pain and recovery after~     bowel surgery. Half of the patients will have an infusion of a local anaesthetic called~     ropivacaine and half will have an infusion of placebo in addition to their normal pain~     relief.~   "
46397|NCT02449707|"~     Ultrasound activated pins have been used for the promotion of bone healing in combination~     with biodegradable membranes during bone grafting procedures. In the jaws, these pins have~     been successfully tested for both maxillary and mandibular ridge augmentaton. However, the~     usefulness of these pins in maxillary sinus lift procedures has not been tested. This study~     aims to use a bilateral split mouth design to compare the bone formation, healing and~     post-operative complications after the use of ultrasonic guided pins in a lateral window~     maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus~     augmentation procedure procedure performed without the use of these pins.~   "
46398|NCT02449694|"~     A prospective, single-center controlled trial to evaluate the safety and performance of the~     portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for~     transplantation.~   "
46399|NCT02449681|"~     This phase 2 study is designed to evaluate the safety and activity of TH-4000~     (Tarloxotinib), a hypoxia-activated prodrug in participants with recurrent or metastatic~     squamous cell carcinoma of the head and neck or skin.~   "
46400|NCT02449668|"~     The main objective of the current study was to assess the analgesic effect achieved to~     short- and medium-term by the use of acupuncture on individuals with impingement syndrome of~     the shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary~     objectives were also sought, such as the short- to medium-term functional recovery of the~     affected joint, knowing the possible influence that this has over the recovery of the~     laterality of the subject, as well as the development of a protocol to select points to~     treat pain affecting the shoulder area.~   "
46401|NCT02449655|"~     Phase II trial of AZD5363 plus paclitaxel / AZD2014 plus paclitaxel in biomarker negative~     (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma patients as second-line~     chemotherapy.~      Each arm is composed of 25 patients.~      AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week that paclitaxel is~     given + paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle. AZD5363 and paclitaxel~     will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week~     cycles.If paclitaxel therapy is stopped then AZD5363 can be given on a 4on/3off continuous~     schedule.~      AZD2014 50mg BD 3 days on 4 days off of a 7 day cycle + paclitaxel 80mg/m2 given days 1, 8~     and 15 of a 28 day cycle.~      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted~     at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of~     first dose, up to week 40, then every 16 weeks until objective disease progression (within a~     window of +/- 7 days of the scheduled date).~      Study treatment will be continued until objective disease progression.~      The purpose of this study is to investigate the safety and efficacy of AZD5363 plus~     paclitaxel in biomarker negative (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma~     patients as second-line chemotherapy.~   "
46402|NCT02449642|"~     Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles~     triggered by GnRH agonist for final oocyte maturation.~   "
46403|NCT02449629|"~     This study uses a transformative multiphasic mixed-methods research design that incorporates~     elements of the following designs:~        -  Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086,~          and ATN 106, to influence the development of the qualitative interview and quantitative~          survey instruments for primary data collection.~        -  Convergent parallel: concurrent collection and analysis of both qualitative and~          quantitative primary data that will be combined to address the study objectives.~   "
46404|NCT02449616|"~     The purpose of this study is to evaluate the safety of repeat administration of MST-188~     during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate~     the development of acute chest syndrome during VOC and re-hospitalization for recurrence of~     VOC.~   "
46405|NCT02449603|"~     This is a multi-centre, open-label, randomized, parallel trial to compare the effect of~     Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers~     in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin~     monotherapy.~   "
46420|NCT02449408|"~     The purpose of this study is to evaluate the accuracy of a new device that may be used for~     the evaluation and management of malnourished infants and children. The device will measure~     the levels of two hormones made by fat tissue: leptin and adiponectin.~   "
46421|NCT02449395|"~     This study is designed to collect data on precipitating factors, diagnosis, morbidity,~     therapy, quality of life, and symptom severity, etc. informations in patients with~     fibromyalgia.~   "
46406|NCT02449590|"~     AIMS:~      The aims are to investigate whether:~        -  Increased intake of onion (powder) affects plasma lipid profile, blood pressure,~          indices of insulin sensitivity and blood coagulation.~        -  Increased intake of onion (powder) affects the expression/activity of enzymes in the~          defence against foreign substances, e.g. reactive oxygen species, and whether~          polymorphisms in some of the involved genes may modulate the effect.~        -  Polymorphisms involved in the metabolism/effect of bioactive components in onion~          modulate the excretion of metabolites or modulate some of the outcome variables in the~          study.~      Other aims are to try to identify biomarkers for onion consumption in plasma, urine and~     feces and to investigate whether onion affects the secretion of fat and bile acids.~      HYPOTHESES:~      The investigators hypothesize that:~        -  2 weeks of increased onion intake will improve the plasma lipid profile~        -  2 weeks of increased onion intake will increase the metabolism of potentially harmful~          substances (such as ROS and free radicals) through a change in the expression or~          activity of certain enzymes.~        -  That these effects are modulated by common gene variants (polymorphisms)~   "
46407|NCT02449577|"~     The objective of the study is to identify biomarkers for acute intake of beer and alcohol in~     individuals with a high or low habitual intake. Furthermore, we wish to identify compounds~     and metabolites in different types of beer and alcohol, which can serve as compliance~     markers for intake under the test conditions (blood tests and urine samples). We also wish~     to determine the acute effects of these beverages on plasma glucose and insulin response,~     compared to regular soda.~   "
46408|NCT02449564|"~     This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and~     PIK3CA amplication Refractory solid tumors.~      sirolimus 1mg will be administered orally qd daily.~      To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA~     amplication Refractory solid tumors.~   "
46409|NCT02449551|"~     Volitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was~     found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both~     enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell~     activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene~     amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also~     potently inhibited HGF-stimulated cell proliferation against tumors with c-Met~     overexpression or carrying a HGF/c-Met autocrine loop.~      This study is a single-arm, phase II study of votilinib in patients with advanced gastric~     adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will~     be administered orally once a day for 21 days as one cycle.~      To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma~     harboring MET amplification.~   "
46410|NCT02449538|"~     This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA~     mutation and PIK3CA amplification Refractory Solid Tumors .~      Everolimus 10 mg will be administered orally qd daily.~      To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA~     mutantion and PIK3CA amplification Refractory Solid Tumors.~   "
46411|NCT02449525|"~     The perfusion of microvascular free flaps is inevitable for completion of reconstruction in~     the head and neck area. In some patients microvascular anastomosis is impossible because of~     arteriosclerotic changes, different oncological interventions, and consecutive vessel~     depletion at the neck. The aim of the project is to establish an innovative system for~     extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the~     wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is~     required for free flaps to survive and provide functional and aesthetic reconstruction.~   "
46412|NCT02449512|"~     Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's~     disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic~     lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current~     gold-standard for evaluating LUT function. Nevertheless, the sensory situation of the LUT~     cannot be investigated objectively. Furthermore, the current classification of the severity~     of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the~     LUT. Additional investigations therefore need to be established for assessing the sensory~     situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for~     investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI~     individuals have not yet been investigated.~      A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance~     images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder~     after SCI can be visualized. The structural presentation of bladder innervation will be~     compared with the functional results, i.e. the SEP of the LUT in SCI individuals.~      The primary objective of the proposed study is to elicit and characterize (latency,~     amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals~     suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.~      Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves~     (N. tibialis, N. pudendus, N. medianus).~      Moreover, the latency and amplitude of the SEPs from the bladder of individuals with~     somato-sensory complete spinal cord injury will be compared with those from the bladder of~     individuals with somato-sensory incomplete spinal cord injury.~      Finally, the structural innervation of the bladder after SCI will be compared with the~     remaining sensory function.~   "
46413|NCT02449499|"~     Depression and anxiety disorders, even when treated according to standard of care consisting~     of individual treatment with medication and/or therapy, can be associated with significant~     residual impact on quality of life. The purpose of this research is carry out an~     observational study of an existing clinical treatment, adjunctive interpersonally focused~     psychodynamic group therapy, to determine if this can improve quality of life for patients~     who have residual symptoms of chronic depression and anxiety.~   "
46414|NCT02449486|"~     Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting~     (CABG) or heart valve surgery to diminish postoperative pain.~   "
46415|NCT02449473|"~     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase~     2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma~     Inadequately Controlled on Inhaled Corticosteroid.~   "
46416|NCT02449460|"~     The study addresses epidemiology of cardiovascular risk factors and major cardiovascular~     diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants~     in each will be included.~   "
46417|NCT02449447|"~     To asses the clinical effectiveness of blended cognitive behavior therapy (CBT):~     face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in~     primary care compared to treatment as usual.~   "
46418|NCT02449434|"~     This is a questionnaire based study investigating the relationship between the timing of~     dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the~     timing, nature, frequency and duration of dietary acid intakes and timing and frequency of~     the participants toothbrushing. Signs of the participants erosive tooth wear will then be~     recorded~   "
46422|NCT02449382|"~     The patients with severe hypernatremia who received conventional treatment are often~     undertreated. Continuous venovenous hemofiltration (CVVH) can effectively remove solute or~     water from circulation system. Several case reports demonstrated that CVVH could effectively~     decrease serum sodium concentration of the patients with severe hypernatremia. The use of~     CVVH for acute severe hypernatremia in critically ill patients could improve patient~     survival by effectively decreasing the serum sodium concentration to a normal level.~   "
46423|NCT02449369|"~     This is a prospective, three-arm, randomized, open-label trial to determine if a new pain~     control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine~     for 48 hours after total knee surgery reduces the need for opioid pain medication and~     reduces average pain scores.~   "
46424|NCT02449356|"~     In this study, the investigators adopt the special endotracheal tube to those patients at~     prone posture during the operation,or those with acute respiratory distress syndrome in ICU,~     so that the investigators can reduce, or even avoid some severe complications during~     perianesthesia, and that the investigators can provide strong safeguard measures for the~     respiratory therapy of critical patients in ICU.~   "
46425|NCT02449343|"~     Compare the effects and safety of Anlotinib with placebo in patients with soft tissue~     sarcoma.~   "
46426|NCT02449330|"~     This is the clinical trial designed to assess the cardiac diastolic function of long term~     treatment with teneligliptin compared to that without teneligliptin in patients with type 2~     diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less~     than 8, the other includes patients showing E/e' by echocardiography more than 8.~   "
46427|NCT02449317|"~     Bioelectrical impedance analysis guided volume expansion for the prevention of contrast~     induced-acute kidney injury~   "
46428|NCT02449304|"~     All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding~     (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a~     normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical~     therapy that persists despite treatment with recommended pharmacological agents(1,2), who~     have no desire to preserve their fertility and are willing to have an endometrial ablation~     will be invited to participate. Eligible women with HMB will undergo radiofrequency G4~     endometrial ablation in either an inpatient or outpatient setting according to their~     preference.~      Outcomes will be assessed by administering postal questionnaires to measure menstrual~     bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline~     and at 6, and 12 months after ablative treatment. After the main study, there will be an~     additional evaluation of the long-term effects of outpatient ablative treatments of the~     endometrium by postal survey at 5 years.~   "
46429|NCT02449291|"~     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,~     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of~     established PONV, in patients who have not had prior PONV prophylaxis.~   "
46430|NCT02449278|"~     The standard treatment approach for patients with stage III-IV DLBCL is combination~     chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was~     associated with improved in-field control and event-free survival. However, it is uncertain~     for the radiotherapy field size to treat for these patients after chemotherapy.~     Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for~     patients with stage III-IV DLBCL. There is not a clinical trial to research whether the~     sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain~     the same efficacy as IFRT and decrease toxicities related to radiotherapy.~   "
46431|NCT02449265|"~     The most common option of radiotherapy for patients with limited-stage DLBCL is~     involved-field radiotherapy (IFRT). The more limited radiotherapy field size changing from~     IFRT to reasonable margin from gross tumor has been reported to maintain the high rates of~     local disease control, while minimizing the risks of radiation-induced toxicities. However,~     the research didn't analyze whether the efficacy of consolidation involved-site radiotherapy~     (ISRT) be affected by the response of chemotherapy. The biologic definition of clinical~     target volume (CTV) of ISRT and actual radiotherapy field size need to be ascertained.~   "
46432|NCT02449252|"~     Radiotherapy (RT) is an important option for patients with limited stage FL. The recommended~     approach for patients with limited stage FL by The National Comprehensive Cancer Network~     (NCCN) is 24Gy~30Gy consolidation RT following effective systemic therapy. There is no~     universal consensus for a ''standard'' RT field size in the treatment of limited stage FL.~     The involved-site radiotherapy (ISRT) has been treated effectively for these patients.~     However, the certain target volumes of ISRT need to be defined for patients with limited~     stage FL after effective chemotherapy.~   "
46433|NCT02449239|"~     Because of the high risk for development of muscle invasive disease, cystectomy is~     recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence~     following intravesical therapy. Vicinium is an experimental agent that may provide an~     alternative to cystectomy~   "
46434|NCT02449226|"~     ICU patients are at high risk of ionic or metabolic disturbances during the course of their~     critical illness. Some of these disturbances might be life-threatening and require rapid~     response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin~     and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid~     and appropriate therapy. This technology has largely improved the quality of care in ICU.~     However, the accuracy of the measurement of those parameters had to be close enough to the~     reference method, usually perfomed in the central lab but time consuming. Recently, a novel~     generation of blood gas analyser has been released. Among them, the RapidPoint 500 is~     mounted with a 28-day cartridge which provides automatic calibrations and quality controls~     several times a day. Such a technology dramatically decreases the need for labs technical~     interventions. To date, there is no data reporting the accuracy of this device. Therefore,~     the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference~     measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and~     Beckman&Coulter DXH for hemoglobin).~   "
46435|NCT02449213|"~     This prospective, longitudinal study of Chinese American immigrants will examine whether~     psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are~     associated with markers of type 2 diabetes risk over time, and whether such associations are~     mediated by inflammatory pathways.~   "
46436|NCT02449200|"~     Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive~     effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a~     research gap exists for optimal management in the first 12 weeks and short-term natural~     history of the condition is unclear, although thought to be favourable within the first 4~     weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to~     investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and~     upper limb unloading tape compared to advice to stay active, on disability, pain and other~     biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The~     hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in~     self-reported disability and pain, compared to advice to stay active, in patients with acute~     / sub-acute cervical radiculopathy. A secondary study objective is to identify whether~     variables from the baseline examination, group allocation and aetiology confirmed by MRI can~     predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be~     diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation,~     allocation concealment, blinded assessment and intention to treat analysis will be employed.~     Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability~     and their rating of recovery will also be recorded by telephone interview at 6 months. An~     internal pilot feasibility study will be undertaken in advance of the main study to test~     recruitment and retention strategies. Statistical analysis of differences between groups~     will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be~     used to explore predictors of outcome.~   "
46437|NCT02449187|"~     A randomized, open-label, single dose, crossover study to investigate the effect of food on~     the pharmacokinetics of JLP-1310 in healthy male volunteers.~   "
46438|NCT02449174|"~     The objective of the study is to investigate the safety of a frozen or lyophilized inoculum~     administered, respectively, by retention enema or capsules in patients with recurrent C.~     difficile associated diarrhea (RCDAD).~      This is a single center, randomized, parallel assignment, open label safety study conducted~     in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1~     ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized~     donor intestinal bacteria. All subjects will be followed for a total of 3 years after study~     completion.~      Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases~     at University of Texas School of Public Health (UT-SPH). The donors will come from a variety~     of places, including the UT-SPH. We will screen at least 20 donors to recruit at least 15~     qualified donors.~      Recipients may self-refer but must have a physician who agrees to accept care of the patient~     following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor~     St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in~     the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention~     enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the~     Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized~     intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's~     care will be returned to their physician. We will screen at least 75 recipients to recruit~     50 qualified recipients.~      The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with~     secondary endpoint related to efficacy prevention of RCDAD. In order to monitor any health~     effects for safety, participants will be contacted pre- and 7, 14, 30 days, then monthly~     basis for the first 90 days after FMT and quarterly till 3 years after FMT. The following~     procedures will be completed: review recipient diary with the recipient to ensure that the~     following information is recorded correctly and a fresh stool sample will be collected from~     recipient, tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome~     analysis. Recipients will be contacted by phone for their diarrhea status on monthly basis~     till 90 days after FMT, then on quarterly basis till 3 years after FMT.~   "
46439|NCT02449161|"~     Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined~     by International Federation of Gynecology and Obstetrics as the perception of menstrual~     volume increased regardless of the frequency, duration and regularity. Some studies report~     that up to 30% of women will suffer from heavy periods during their lifetime. The first line~     treatment of heavy bleeding is medical. However, a significant proportion of women require~     surgery. Until the 80s, hysterectomy was one of the only surgical options and often~     performed as the first line treatment. Since twenty years now the endometrial ablation has~     become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a~     significant proportion of patients suffering from this type of problem. Endometrial ablation~     is much less invasive and morbid than hysterectomy, however, many patients do not achieve a~     complete amenorrhea with endometrial ablation and about 15% may have to require a new~     intervention, such as hysterectomy, following the persistence of menstrual problems. A~     Cochrane review published in 2013 showed that the satisfaction rate following endometrial~     ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction~     of the endometrium is the most important predictor of the success of the procedure. Studies~     have shown that better results are obtained when the surgery is performed when the~     endometrium is thin or immediately following menses or following administration of a~     hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the~     endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and~     oral. Progestins have an antiproliferative effect on the endometrium. In recent years,~     numerous studies have examined the use of various agents preoperatively, including MPA and~     DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few~     studies have focused on the conditions of the post-operative period to promote the~     therapeutic response to the intervention. The investigators hypothesis is whether the MPA~     administered in immediate post-operative would inhibit proliferation of endometrial cells~     responsible for the persistence of menstruation and optimize the clinical response to~     endometrial ablation.~   "
46440|NCT02449148|"~     This study evaluates the effect of intermittent calorie restriction versus continued calorie~     restriction on weight loss, gene expression profile of subcutaneous adipose tissue and~     abdominal fat distribution.~   "
46441|NCT02449135|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional~     therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is~     made by mixing Gemzar® with Compound Glycyrrhizin Injection.~   "
46442|NCT02449122|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional~     therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by~     mixing Gemzar® with Compound Glycyrrhizin Injection.~   "
46443|NCT02449109|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix~     with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction~     angiography（DSA） for liver cancer.~   "
46453|NCT02448979|"~     Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical~     resection remains the most effective method for this malignancy. Although different~     approaches have been studied for the surgical resection of thoracic esophageal cancer,~     little evidence has been achieved due to lack of large scale multicenter randomized trials~     with regard to this issue: whether left transthoracic approach or right transthoracic~     approach is the optimal surgical approach for treating middle and lower thoracic esophageal~     cancer without upper mediastinal lymph node metastasis. The purpose of this study is to~     compare the postoperative local recurrence rate and long-term outcome of esophagectomy~     through left and right transthoracic approach in the middle and lower thoracic esophageal~     cancer patients without preoperative upper mediastinal lymph node metastasis.~   "
46490|NCT02448498|"~     The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the~     effectiveness of different exercise regimen types in controlling diabetes for the normal~     weight type 2 diabetes population.~   "
46444|NCT02449096|"~     Background: An anatomical reconstruction of ankle congruity is an important prerequisite in~     the operative treatment of acute ankle fractures. But, despite an anatomic reduction,~     patients suffer from residual problems like chronic pain, stiffness, persistent swelling and~     instability after these fractures. There is growing evidence, that this poor outcome is~     related to the concomitant traumatic intraarticular pathology. Therefore, supplementary~     ankle arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to~     confirm the anatomic reposition and to further identify and manage associated intraarticular~     injuries. The arthroscopic treatment of these pathologies might result in a better outcome~     after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures~     are managed by open procedures only. Still, indications for arthroscopically assisted open~     reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of~     AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined~     for complex ankle fractures. In this context, only a prospective randomized study can~     sufficiently answer these open questions. Therefore, the investigators plan a randomized~     controlled trial intended to report the short-, midterm- and long-term follow-up of patients~     who underwent operative treatment of acute ankle fractures - with and without ankle~     arthroscopy.~      Methods/Study design: The investigators will perform a randomized controlled trial~     evaluating the effect of AORIF compared to ORIF with a sample size of 40 patients per group.~     The investigators include patients with an acute ankle fracture after written informed~     consent. Primary outcome of the investigators' study is the difference of the AOFAS score~     (American Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison~     (ORIF) group after a follow-up of 2 years. Several secondary outcome parameters will be~     assessed as well. Statistical analysis will be performed using a two-sided Student`s t-test.~      Discussion: Until today, there are only two randomized controlled trials evaluating the~     effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted~     open reduction and internal fixation (AORIF). Both studies only included patients with~     isolated fractures of the distal fibula at the level of the syndesmosis. These are the most~     simple fractures that are regularly treated operatively. Both studies documented a high~     incidence of intraarticular disorders in the AORIF group, but only one could show~     significant better results in the AORIF group. Moreover, several other studies could~     consistently demonstrate that the intraarticular damage is even more pronounced the more~     complex the fracture is. Consequently, a more distinctive effect of arthroscopy in complex~     fractures involving two malleoli or more has to be assumed when compared to these simple~     fractures.~   "
46445|NCT02449083|"~     There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet~     resonance imaging can differentiate between oxygenated and deoxygenated blood.~      In adult patients with inborn heart defects this has not yet been researched.~     Therefore,patients with ventriculoperitoneal shunt, septal and atrio-septal shunt should be~     examined. Also, patients with chronic obstructive pulmonary disease should be examined.~      The aim of this study is the validation of a novel magnet resonance sequence in terms of a~     distinction of oxygenated blood to deoxygenated blood in comparison to invasive method of~     measuring cardiac catheterization.~   "
46446|NCT02449070|"~     The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in~     patient with ST-segment elevation acute myocardial infarction.~   "
46447|NCT02449057|"~     Arizona has created a pilot program for juvenile probationers called Juveniles under~     Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to~     technical violations of the terms of juvenile probation. JUST targets high- and medium-risk~     juvenile probationers and its stated objective is to reduce violations and overall~     incarceration of youth in the program. The JUST pilot is being implemented under the~     authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the~     Administrative Office of the Courts (AOC).~   "
46448|NCT02449044|"~     This study will assess the safety of long-term tolvaptan use in patients previously enrolled~     in shorter-term Phase 3 studies and gather information on the natural history of~     hyponatremia in the context of tolvaptan therapy and underlying disease states.~   "
46449|NCT02449031|"~     This is a multicenter, prospective, two cohort, observational study over a 5-year period in~     Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will~     collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical~     outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on~     microbiological and safety assessments.~   "
46450|NCT02449018|"~     To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo~     administered orally, on airway function, lung volume, and quality of life in patients with~     chronic obstructive pulmonary disease (COPD)~   "
46451|NCT02449005|"~     Systemically healthy periodontitis patients are recruited from new referrals to the~     Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical~     periodontal treatment those subjects who have at least one interdental osseous defect with~     probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥~     3mm with no endodontic or furcation involvement are randomly allocated into one of the three~     treatment groups. Group A receives regenerative treatment using autologous bone marrow~     mesenchymal stem cells free of animal derived reagents, produced in clean room facilities~     and seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece~     enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives~     open flap debridement retaining the soft wall of the defect. Thereafter, subjects are~     followed for 12 months and are repeatedly assessed based on clinical, radiographic,~     immunological and microbiological parameters.~   "
46452|NCT02448992|"~     Background. During the clinical course of patients with locoregionally advanced~     non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain~     metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It~     still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain~     radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or~     pathologically nodal positive disease. Actually, PCI would significantly decrease the~     incidence of BM; however, potential WBRT-related neurocognitive function (NCF) sequelae are~     indeed a concern, which has made PCI seldom applied in clinical practice. In terms of the~     time course of WBRT-induced NCF decline, it might vary considerably according to the~     specific domains which are selected to be measured. Early neurocognitive decline principally~     involve impairments of episodic memory, which has been significantly associated with~     functions of the hippocampus. This study thus aims to explore the impact of PCI on the~     subsequent risk of developing BM and the multi-domain neurobehavioral functions in our~     eligible patients.~      Methods. Potentially eligible subjects are postoperative NSCLC patients with a status of~     pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will~     undergo the course of hippocampal-sparing PCI after they complete the fourth course of~     adjuvant platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions~     during three weeks. Except for the administration of hippocampal-sparing PCI, patients~     assigned to the observation arm should receive the same baseline and follow-up brain imaging~     examinations and neurocognitive assessments as those in PCI arm. Accordingly, a battery of~     neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g.,~     executive functions, verbal & non-verbal memory, working memory, and psychomotor speed), is~     used to evaluate neurobehavioral functions for our registered patients.~      Expected results. This randomized controlled study aims to verify that the incidence of BM~     still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF~     preservation regarding neurobehavioral assessments might also be achieved by~     hippocampal-sparing PCI as compared with the observation arm without PCI. No matter what the~     final results present, it is believed that this randomized controlled trial (RCT) will~     provide us solid evidence concerning the exact value of hippocampal-sparing PCI in our~     patient setting.~   "
46485|NCT02448563|"~     In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based~     weight loss program to reduce obesity among postpartum African American (AA) adult women~     that can be integrated into a postpartum care model within a clinical setting.~   "
46454|NCT02448966|"~     Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection~     remains the most effective method for this malignant disease. VATS esophagectomy has become~     more and more popular in China and around the world. Although VATS esophagectomy has been~     proven to be effective in preventing respiratory complications, there is still no ample~     evidences to demonstrate that VATS esophagectomy is as effective as traditional~     three-incision esophagectomy in lymph node dissection and is equal or superior in long-term~     survival. The purpose of this large scale prospective observational study is to compare the~     minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision~     esophagectomy in lymph node dissection, postoperative recovery, postoperative complications,~     and long-term survival.~   "
46455|NCT02448953|"~     The purpose of this study is to compare the lymph node dissection results and prognosis in~     thoracic esophageal carcinoma patients without cervical lymph node involvement by~     preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field~     lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the~     right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to~     indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.~   "
46456|NCT02448940|"~     The investigators aimed to study the effect of supplementation with species of Lactobacillus~     on anthropometric measurements, body composition, appetite and serum lipid profile in~     overweight and obese adults~   "
46457|NCT02448927|"~     This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV)~     on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI)~     procedure. Patients will undergo a physical exam, coronary angiography and computed~     tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with~     BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at~     Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of~     all the imaging modalities for each patient. The patients will be followed during the~     hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of~     predilatation will be at the operator's discretion.~   "
46458|NCT02448914|"~     This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa~     on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All~     patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone)~     and Duodopa (levodopa and carbidopa), in randomized order.~   "
46459|NCT02448901|"~     The influence of different doses of edoxaban on physical characteristics of the clot and~     thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood~     samples collected from patients treated for heart failure (with and without~     hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This~     in vitro experiment will help us to:~      (i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting~     properties of edoxaban.~   "
46460|NCT02448888|"~     Objective: The purpose of this study is to investigate the effects of a adapted exercise~     program and general exercise recommendations compared with only general exercise~     recommendations for the management of chronic back pain among the workers of BSH (Bosch~     Siemens Hausgeräte), a manufacturing company.~   "
46461|NCT02448875|"~     This study is to assess the safety and effectiveness of the use of visco-assisted CyPass~     Micro-Stent implantation for the lowering of intraocular pressure (IOP) in patients who have~     open angle glaucoma (OAG).~   "
46462|NCT02448862|"~     In this retrospective study, postoperative pain score, PCA-related complications, the risk~     factors for requirement of rescue analgesics and antiemetics will be evaluated in young and~     elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours~     after various surgeries.~   "
46463|NCT02448849|"~     Nonunion of long bones would occur in almost 10% of fractures and because of its long term~     and complicated treatment, is known as a therapeutic challenge for both of the surgeons and~     patients.~      Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the~     best candidates for this kind of treatment.~      Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in~     combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients~     as the control group will receive placebo. The patients will be followed at 2weeks, 3months,~     6m and 12 months after implantation.~      The Spss(v16) software will be used for data analysis.~   "
46464|NCT02448836|"~     Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes~     significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms~     are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are~     limited, with 40% non-responders.~      Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is~     based on modulating neural activity by inducing an electric field in the brain. To date,~     dTMS was found to be an effective treatment for depression, which is highly comorbid with~     PMDD.~      The investigators propose to study the effect of dTMS on PMDD patients in a prospective~     treatment study.~   "
46465|NCT02448823|"~     The study will test a novel demand generation strategy, Stylish Man/Stylish Living, to~     increase uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes~     evidence-based interventions, including safe voluntary medical male circumcision (VMC),~     antiretroviral therapy (ART), prevention of mother to child transmission (p-MTCT) and~     behavioral interventions. With President's Emergency Fund for AIDS Relief (PEPFAR) funds,~     the Rakai Health Sciences Program (RHSP) provides CHP in Rakai District, Uganda. Our ongoing~     54 village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from~     6% to 42%, provides longitudinal data on rates of CHP coverage and on HIV incidence. The~     investigators have preliminary evidence that CHP is reducing HIV incidence in Rakai, but~     coverage remains suboptimal (as elsewhere in Africa), particularly in men, reducing program~     impact. Our data suggest that CHP supply is not the limiting factor, but that there is a~     deficit in demand.~      Based on extensive qualitative research, the investigators have developed and piloted an~     innovative male-focused CHP demand generation strategy, the Stylish Man/Stylish Living~     Program (SMLP) which is male-friendly without excluding exclude women. The SMLP strives to~     demedicalize CHP by deemphasizing health-focused messages and instead stressing taking~     charge of your life. The SMP has two distinct but related elements: (1) mass media (MM) via~     radio and posters; and (2) community-level mobilization via the Stylish Man/Stylish Living~     Event (SMLEvent) which includes multimedia media (the Stylish Van, videos, music, health~     promoters) into which the investigators have embedded CHP promotion, and immediate access to~     services. In this study, the investigators will conduct a 3 year cluster randomized trial of~     MM plus SMLEvents (intervention arm) compared to MM alone (control), in 25 RCCS communities~     per arm aggregated into ~10 clusters per arm (50 communities in all). The primary outcome~     will be intent-to-treat community-level rates of CHP coverage by arm. The investigators will~     also monitor rates of key behaviors and HIV incidence, and compare them between arms and to~     rates observed in communities in each arm prior to study initiation (secondary outcomes).~   "
46466|NCT02448810|"~     The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination~     with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase~     II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination~     with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects~     with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice~     as third or fourth treatment line in subjects with progressive measurable metastatic~     colorectal cancer (mCRC).~   "
46467|NCT02448797|"~     Adjuvant therapy has been proved effective in treating earlier stage or less advanced~     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as~     adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR~     mutation. The primary endpoint is disease-free survival.~   "
46468|NCT02448784|"~     To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil~     hydrochloride in clinical practice as well as its proper use information in participants~     with DLB.~   "
46469|NCT02448771|"~     This research study is studying a drug called Palbociclib in combination with Bazedoxifene~     (a type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen~     stimulation) as a possible treatment for this diagnosis.~      The names of the study interventions involved in this study are:~        -  Palbociclib~        -  Bazedoxifene~   "
46470|NCT02448758|"~     The investigators propose to create a database at the regional level, the principle is to~     include all patients in whom a mutation was detected from a single platform (Lille). The~     creation of this regional cohort, smaller than the national cohort of Biomarkers France,~     will perform a more comprehensive collection of clinical data, and molecular monitoring data~     of patients included. To increase the completeness of the collection of information, it will~     not be based on voluntary prescribing clinician but will be largely carried out by CRA~     dedicated to this activity.~   "
46471|NCT02448745|"~     A cluster-randomized control trial will study the effect of insecticide-treated wall lining~     on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study~     will receive insecticide-treated wall lining covering their walls and ceilings in addition~     to long-lasting insecticidal nets, while the other half will be protected by existing~     long-lasting insecticidal nets.~   "
46472|NCT02448732|"~     The purpose of this study is to investigate the role of intravitreal injection of~     anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of~     ophthalmological neovascular diseases, in order to find a new strategy of treatment for~     ophthalmological neovascular diseases~   "
46473|NCT02448719|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-792~     when administered as a single oral dose in healthy Japanese and Caucasian male participants.~   "
46474|NCT02448706|"~     The goal of this project is to find out if the way a hearing aid processes a sound signal~     should be determined in part by an individual's cognitive characteristics. We anticipate~     that the outcome of this work will be a battery of assessments that will guide hearing aid~     processing for older patients with hearing loss.~   "
46475|NCT02448693|"~     This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI)~     compared with High Definition White Light colonoscopy (WLE) for detection of residual~     neoplasia in subjects with piecemeal polypectomy scars.~   "
46476|NCT02448680|"~     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2~     separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for~     the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor~     VIII or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12~     years old).~   "
46477|NCT02448667|"~     Patients suffering from the metabolic myopathy Glycogen Storage Disease type IIIa (GSDIIIa)~     have a problem releasing sugar stored in cells that is needed for energy production. This~     causes several systemic impairments, but only recently have the exercise-related symptoms in~     the muscles been examined. A previous study showed signs that intravenous infusion of~     glucose relieves some of these symptoms. The purpose of this study is to investigate in a~     randomized and placebo-controlled fashion whether oral ingestion of sugar can alleviate~     muscular symptoms in patients with GSDIIIa.~   "
46478|NCT02448654|"~     The purpose of this study is to use a medication tolcapone and or placebo to test if the~     symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental~     reasoning in female smokers over a 72 hour period.~   "
46479|NCT02448641|"~     Controlled study of stereotactic, intracranial injection of SB623 cells in patients with~     fixed motor deficits from ischemic stroke~   "
46480|NCT02448628|"~     This study is a multi-center, open label, dose titration, exploratory study to evaluate~     efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal~     impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood~     pressure.~   "
46481|NCT02448615|"~     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of~     only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding~     of the causes of child mortality is necessary to guide research efforts aimed at tackling~     this important global health problem. Prospective birth cohort studies present an~     opportunity to examine the relationships between early-life exposures and multiple health~     and non-health related outcomes including death, illness, and socioeconomic factors. In this~     study, the investigators will provide insight into the underlying causes of child mortality~     by collecting data on early-life exposures and health and non-health related outcomes in the~     first year of life.~   "
46482|NCT02448602|"~     With primary insomnia as the research object, by the method of multi-center RCT and needle~     single cavity and different acupoints compatibility treatment for primary insomnia, to~     Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and~     Polysomnogram(PSG) as the means, such as the single cavity with different acupoints~     compatibility evaluate clinical curative effect of treating primary insomnia.~   "
46483|NCT02448589|"~     A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic~     and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.~   "
46484|NCT02448576|"~     The purpose of this study is to compare whether prophylactic cranial irradiation in patients~     with advanced triple negative breast cancer who had a response to first line chemotherapy~     could prolong brain-metastasis free survival.~   "
46492|NCT02448472|"~     Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the~     incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies~     among different clinic trails. In addition, clinician empirical select antibiotic according~     to the epidemiology of sepsis, however, the etiology of sepsis is various in different~     studies. In China, the MDRO is much higher than western country. There is no study about the~     epidemiology of sepsis in China. Therefore, it is necessary to conduct a study about it in~     China.~   "
46493|NCT02448459|"~     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled~     ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the~     number of oocytes retrieved.~   "
46494|NCT02448446|"~     This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in~     subjects with diabetic macular edema and lipid exudates in the central subfield.~   "
46495|NCT02448433|"~     Bright light therapy is an established treatment pathway for sleep and circadian disorders~     and evidence suggests that it has antidepressant effects. The underlying mechanisms of these~     antidepressant effects are not fully understood and results from previous studies are~     somewhat variable. One of the important limitations of previous depression studies has been~     the heterogeneity of samples in which bright light therapy has been administered.~      The main aim of this study is to evaluate whether the antidepressant effects of phototherapy~     in young persons with depression are modulated by changes in the sleep-wake cycle. We~     hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant~     response to phototherapy and that the magnitude of changes in depressive symptoms across the~     course of the intervention will correlate with changes in the sleep-wake cycle.~   "
46496|NCT02448420|"~     This is a phase II, prospective, open-label, multicentre, Simon's two-stage-design study of~     the combination of palbociclib plus trastuzumab, with or without letrozole, in~     post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer~     (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic~     disease.The aim of the PATRICIA study is test the hypothesis that the addition of~     Palbociclib to standard therapy is well tolerated and can provide a benefit in~     progression-free survival in patients with HER2-positive breast cancer previously treated~     for their metastatic disease.~   "
46497|NCT02448407|"~     Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and~     platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also~     recently recognized a regenerative cell potential improving the concentration of hyaluronic~     acid and stabilizing angiogenesis in arthritic knees~      This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees~     intraarticularly infiltrated, and which patients would benefit most from treatment,~     eliminating false expectations in the rest.~   "
46498|NCT02448394|"~     This study, to be conducted in southern Ethiopia, is a randomized community trial,~     evaluating the use of local community support workers who provide for HIV patients~     education, counseling/social support, and linkage to the HIV Clinic. Patients will be~     followed for at least three years, with a primary goal of improving retention in HIV care,~     and secondary goals of improving client knowledge, attitudes about being HIV-positive,~     feelings of social support and clinical health status.~   "
46499|NCT02448381|"~     To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with~     patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).~   "
46500|NCT02448368|"~     The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules~     compared with RDEA3170 tablets.~   "
46501|NCT02448355|"~     All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during~     about 1 year, will be offered to participate.~      Retinal and choroidal structural changes will be assessed using swept-source OCT technology~   "
46502|NCT02448342|"~     Multi center, randomized controlled study, to determine if a significant decrease in the~     rate of heart failure re-hospitalizations occurs during a follow-up period when - ReDS~     guided treatment is used as an adjunct to standard of care.~   "
46503|NCT02448329|"~     This study is a single arm, single center phase II study of AZD1775 in combination with~     paclitaxel in patients with advanced gastric adenocarcinoma harboring TP53 mutation as a~     second-line chemotherapy.~      Patients will receive AZD 1775 plus weekly paclitaxel combination regimen. The arm is~     composed of 25 patients.~      AZD1775 225 mg BID q 12 hours (x 5 doses) administered days 1~3 + paclitaxel 80 mg/m2 given~     days 1, 8 and 15 of a 28 day cycle.~      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted~     at screening every 16 weeks until objective disease progression .~   "
46504|NCT02448316|"~     The purpose of this study is to compare in a randomized controlled trial the effect of~     endoscopic operation with the standard conservative treatmentprotocol with training~     supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar~     fasciopathia.~   "
46505|NCT02448303|"~     Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced~     non-small cell lung cancer.~   "
46506|NCT02448290|"~     This study is a single-arm, phase II study of selumetinib in combination with docetaxel in~     patients with advanced gastric adenocarcinoma harboring MEK signature, RAS mutation or~     amplification as a second line chemotherapy.~      Selumetinib will be administered orally 75mg twice a day continuously. Docetaxel will be~     administered as an IV infusion over 1 hour at 60 mg/m2 every 3 week of a 21 days schedule.~   "
46507|NCT02448277|"~     Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial~     surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal~     intubation, limited information presents in NTI. The aim of the study is to compare the~     efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.~   "
46508|NCT02448264|"~     This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending~     doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy~     Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug~     BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have~     in the body.~   "
46509|NCT02448251|"~     AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective~     Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer~     patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by~     irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the~     activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of~     EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth~     by EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters:~     1. Irreversible binding to EGFR; 2. Efficiently suppresses the tumor cell with EGFR mutant~     and has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with~     EGFR T790M drug-resistant mutation.~   "
46510|NCT02448238|"~     The composition of the intestinal bacterial flora effects gut immunologic function and~     intestinal barrier integrity. HIV infection impairs gut immune and epithelial function~     resulting in an altered gut bacterial flora and leakage of gut bacterial products into the~     bloodstream. These bacterial products can overstimulate the immune system leading to~     increased inflammation and HIV disease progression. The investigators will investigate~     whether oral supplementation of certain beneficial probiotic bacteria may attenuate these~     processes in HIV infected women in Mali, Africa.~      This is a single arm study to evaluate the effect of 12 weeks of combination oral probiotic~     supplementation (VSL#3, Sigma-Tau Pharmaceuticals - containing 9 × 1011 bacteria of 8~     species: S. thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium~     infantis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus paracasei, and~     Lactobacillus bulgaricus) on plasma biomarkers of immune cell activation, and inflammation.~     The study population will be 50 chronically HIV-infected but generally healthy,~     non-pregnant, Malian women subjects with CD4+ T-cell count ≥ 350 cells/mm3 who are not~     receiving antiretroviral therapy. Blood plasma/serum and fecal sampling will occur at~     baseline, 4, and 12 week as well as at 24 weeks. At these time points, probiotic will be~     dispensed, a medical history will be obtained, and adherence will be assessed. Prior to~     study entry, subjects will have eligibility and safety labs will be obtained and detailed~     baseline medical and symptom histories, demographics, weight, and stool frequency~     information will be recorded. A stress assessment questionnaire will be completed at~     baseline and week 12 to determine the effect of this intervention on stress levels.~      The primary study outcome is to assess change (baseline to 12 week) in plasma soluble CD14~     (a marker of monocyte response to bacterial endotoxin which has been associated with~     mortality) with study probiotic. Other outcomes will include assessing change (baseline to~     12 week) in plasma interleukin-6, soluble CD163 (another monocyte activation marker),~     d-dimer (a marker of coagulopathy), intestinal fatty acid binding protein (a marker of gut~     epithelial cell injury) and fecal calprotectin (a marker of gut inflammation), as well as~     CD4+ T-cell counts, self reported stool quality (using the Bristol Stool Scale), safety and~     tolerability of the VSL#3 probiotic, and level of stress.~   "
46511|NCT02448225|"~     This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)~     positron emission tomography (PET)/computed tomography (CT) to the standard of care~     fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung~     cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the~     common building blocks of protein) called 18F-FSPG which may be able to recognize~     differences between tumor and healthy tissue. Since tumor cells are growing, they need to~     make protein, and other building blocks, for cell growth that are made from glutamate and~     other molecules. PET/CT using a radioactive glutamate may be a more effective method of~     diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as~     18F-FDG.~   "
46512|NCT02448212|"~     The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699,~     using Positron Emission Tomography (PET) scans with or without dosing of TS-121~   "
46513|NCT02448199|"~     Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic~     in 375 subjects with knee osteoarthritis.~   "
46514|NCT02448186|"~     The proposed study will adapt a cognitive behavioral intervention to support high-risk MSM's~     adaptive coping with minority stress, alleviate associated depression and anxiety, and~     reduce HIV risk behavior. The adapted intervention is expected to increase awareness of the~     unhealthy impact of minority stress; facilitate objective self-schemas in the face of~     minority stress; and strengthen one's skills and self-efficacy for managing minority stress~     and associated anxiety and depression to reduce risk for acquiring HIV.~   "
46515|NCT02448173|"~     OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and~      addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase~      IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's~      own cancer cells to mobilize the body's immune system to prevent the return of colon~      cancer following surgery.~   "
46516|NCT02448160|"~     The study will be a single centre, open-label trial. The patients will have a diagnosis of~     refractory ascites and will meet specified inclusion/exclusion criteria Informed consent~     will be obtained from all patients. All patients will have an alfapump surgically inserted~     and in addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of~     Ascites drained. This Intravenous administration will be intermittent (every month) and will~     take place as a day patient. Patients will also receive standard of care, which may include,~     but is not limited to, administration of diuretics, paracentesis and consideration for~     orthotopic liver transplantation.~   "
46517|NCT02448147|"~     BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as~     exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle~     disability and exercise intolerance. The interval exercise training has been proposed as one~     efficient method to heart failure patients. It seems that the main mechanism involved in the~     benefit of the interval exercise training is shear stress. AIM: To study the interval~     exercise training versus the continuous exercise training in the sympathetic activity and in~     the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the~     muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation,~     quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and~     female) with age between 30 and 60 years, left ventricular ejection fraction less than 40%~     and functional class I, II and III. These patients will be randomized into three groups:~     Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with~     microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer,~     cardiopulmonary exercise test and quality of life before and after end of the period of 03~     (three) months.~   "
46518|NCT02448134|"~     This project evaluates a combination of policy and social influence interventions to reduce~     adolescent alcohol use and its sequelae.~   "
46519|NCT02448121|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow~     stem cells in sickle cell disease patients with hip osteonecrosis~   "
46520|NCT02448108|"~     The investigators will conduct a small pilot study to test the feasibility and acceptability~     of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both~     with and without telephone, text, and email support from a clinical helper (CH). The~     ultimate goal of this work is to provide preliminary data needed to design a larger scale~     effectiveness study of online psychotherapy for treating BP in primary care.~   "
46521|NCT02448095|"~     This observational study aims at assessing the tolerability and safety profiles of~     Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive.~     This drug is used during the chronic phase of the disease, according to the Italian national~     compassionate law 648/96.~   "
46522|NCT02448082|"~     Dandruff, also known as Pityriasis capitis, is a common condition which affects the scalp of~     almost half the post-pubertal population regardless of race and gender. It is said that~     dandruff affects at least 50% of the world's adult population and about 15 - 20% of the~     world's total population. Dandruff is usually marked by flaking as well as itching and~     irritation of the scalp which can also lead to greasiness. Dandruff can lead to~     physiological and psychological issues and can be very distressing and embarrassing for the~     sufferer, causing low self esteem and social problems. Current treatment options for~     dandruff include many over-the-counter preparations, anti-dandruff shampoos and topical~     steroid applications which are accompanied by numerous adverse effects. According to Lunar~     Pharmaceuticals Ichthyol® Pale is a sodium salt of pale sulphonated shale oil in aqueous~     solution with anti-microbial properties which can combat dandruff helping with the causative~     and symptomatic relief of this condition.~      The aim of the study is to determine the efficacy of Sodium Shale Oil Sulponate 1% shampoo~     in the treatment of Pityriasis capitis. This will be evaluated using the Adherent Scalp~     Flaking Score (ASFS) grading and the Visual Analogue Scale (VAS).~   "
46523|NCT02448069|"~     Background:~      Our prior work with combination argatroban + recombinant tissue plasminogen activator~     (rt-PA) (ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized~     low and high-dose study; n=90), demonstrated safety of the two drugs when delivered~     concomitantly and recanalization rates were greater than with historical controls. Further,~     interim analysis of neurological outcomes at 75 patients of the randomized Phase IIb trial,~     demonstrated a signal of efficacy when compared to control (rt-PA alone) patients. However,~     rt-PA fails to reperfuse brain in most patients with large thrombi, prompting several recent~     randomized clinical trials which have demonstrated that intra-arterial therapy (IA)~     following rt-PA substantially improves outcome in patients with distal carotid or proximal~     middle cerebral artery occlusions. As a result, rt-PA + IA has become the new~     standard-of-care for many patients with large arterial occlusions such as those treated in~     ARTSS-1 and 2. Therefore, this study is necessary to explore the feasibility and safety of~     adding Argatroban in acute ischemic stroke patients who also receive rt-PA followed by IA.~      Primary Objective:~      To demonstrate the feasibility and safety of treating stroke patients with Argatroban who~     undergo usual thrombolysis care (intravenous rt-PA followed by IA).~      Secondary Objectives:~        1. Assess rates of ultra-early recanalization at commencement of IA;~        2. Assess the completeness and pattern of reperfusion as obtained by IA; 3) Assess~          clinical outcome~   "
46524|NCT02448056|"~     Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading~     cause of cancer-related death worldwide. Treatments of HCC include surgical resection, local~     therapies such as radiofrequency ablation and ethanol injection, transarterial~     chemoembolization, sorafenib and best supportive care. However, even after successful~     treatment such as surgical resection, most patients suffered from recurrence or progression~     of the tumor. Because clinical staging systems cannot precisely predict the outcome of~     patients with HCC, it's of great interest to search serum biomarkers for HCC. Among them,~     alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC~     after surgical resection of tumor or after local therapy is still uncertain.~      MicroRNAs (miRNAs), 17- to 25-nucleotide non-coding RNAs, are frequently dysregulated in~     cancer and emerging as novel non-invasive biomarker for cancer screening, diagnosis, monitor~     therapy efficacy and predict prognosis. MiRNAs are stably expression in serum as their~     resistance to endogenous RNase and easily storage with high stability. Several studies have~     shown abnormal expression of human serum miRNAs in many cancers such as liver, colorectal,~     and pancreatic cancer. The sensitivity of miRNA as a diagnostic biomarker of HCC could be~     upto 80%. Using miRNA arrays can generate miRNA signatures and improve the sensitivity and~     specificity of biomarker for tumor diagnosis and prognosis prediction.~      In this study, the investigators will establish an miRNA platform as biomarkers for~     diagnostic or prognostic tools of HCC. The investigators will also compare the miRNA~     expression level before and after treatment in the serum and correlate the miRNA expression~     between serum and tumor tissue.~   "
46525|NCT02448043|"~     Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients.~     Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on~     bimatoprost and an observational study of patients on bimatoprost in another center reported~     that fingernails grew longer and became less brittle using the topical eye drops to the~     eyes. The purpose of the double-blinded study is to determine whether the application of the~     eye drops directly to the proximal nail fold of one hand using the opposite hand as a~     control will result in longer nails, less brittle nails, and reduced eye pressures should~     any of the medication be absorbed into the systemic circulation.~   "
46526|NCT02448030|"~     Cardiovascular exercise adjustments are required during in order to redistribute blood flow~     from non-exercising vascular areas to active muscles. This hemodynamic adjustments, which~     are partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase~     oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990). Static handgrip~     exercise has been shown to induce alterations in the arterial baroreflex function (Kim,~     2005) and activation of muscle metaboreflex that increases arterial blood pressure and~     peripheral vasoconstriction, respectively. Functional electrical stimulation (FES) treatment~     used in physical therapy in patients who are unable to tolerate conventional exercise showed~     to be a good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic~     abnormalities (Karavidas, 2006). However, the effect of FES on metaboreflex activation in~     healthy individuals has never been investigated. Therefore, this study aims to evaluate the~     metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and~     also to compare their results with the effects caused by isometric exercise.~   "
46527|NCT02448017|"~     Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic~     patients with small lower jaws. Since small lower jaws are reported to be one of the main~     reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used~     to treat SDB children. Previously no study compared the effects of Herbst appliance therapy~     with removable functional appliance on airway dimension, so it still remains unclear which~     kinds of functional appliance is more suitable for improving airway dimension. This study~     will assess the effect of Herbst appliance on airway dimension and compare the effects with~     those of twin block appliance (a popular 24 hours used removable functional appliance, and~     also commonly used to treat adult sleep apnea).~   "
46528|NCT02448004|"~     The primary objective of this study is to characterize the absorption and metabolic pathways~     of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral~     dosing of 14C-JNJ-63623872 in healthy adult male participants.~   "
46529|NCT02447991|"~     Suffering from dizzy spells and migraine headaches?~      Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of~     dizziness.~      University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM~     to participate in a research study. The purpose of this study is to look at the natural~     history of VM and learn more about common symptoms. Investigators also want to learn the~     effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when~     it is used for spells of dizziness in people with VM.~      Patients may be eligible to participate if:~        -  Patients are between the ages of 18 & 65~        -  Patients have a history of vestibular migraine~        -  Patients are able to maintain a vestibular symptom diary~      The study includes 3 visits with compensation. All participants must complete questionnaires~     on dizziness, headache symptoms, general health and well-being, mental health, and a~     questionnaire on patient's satisfaction with study medication.~   "
46530|NCT02447978|"~     The purpose of this study is to assess duration of protection for GSK DTaP vaccines in~     preventing pertussis.~   "
46531|NCT02447965|"~     The purpose of this study is to show that the use of preoperative rectus sheath blocks can~     ultimately alleviate the need for using nondepolarizing muscle relaxants during certain~     abdominal procedures.~   "
46532|NCT02447952|"~     Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral~     Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new~     meaningful measure(s) which might prove to be more effective than existing measures for~     monitoring clinical function and disease course in ALS. The objective of this study is to~     test novel measures of movement/physical activity, heart rate and speech and explore how~     they measure disease progression by evaluating their relationship to gold standard measures~     of function. This study will be conducted in two phases. A variable length Pilot Phase to~     test biotelemetry instruments and algorithms reliability and ease of use/acceptance.~     Approximately 5 subjects will have at least 1 clinic visit to perform a series of set~     reference tasks while wearing the accelerometer and electrode. Subjects will also~     continuously wear the accelerometer and electrode in their routine home-life setting for~     approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot~     Phase will continue in the study and participate in the Core Study Phase. A 48 week Core~     Study Phase will be conducted to evaluate how measures of movement/physical activity, speech~     and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a~     maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform~     gold standard measures of function and perform a series of set reference tasks while wearing~     the accelerometer and electrode. In between clinic visits, every month subjects will attach~     the accelerometer and electrode and wear it for approximately 3 days in their home. A~     telephone contact with the subject will be made by the site at the end of each 3-day home~     monitoring period.~      All third party trademark rights are the rights of their respective owners.~   "
46533|NCT02447939|"~     Present clinical study will be conducted in China to evaluate the pharmacokinetics (PK) of~     single and repeat oral doses of dabrafenib alone and dabrafenib and trametinib in~     combination, the safety profile and the clinical activity of dabrafenib in combination with~     trametinib in Chinese melanoma subjects with BRAF V600E/K mutation. Approximately 20~     evaluable subjects will be enrolled in the study, out of which, the first 10 subjects will~     be enrolled into cohort A (Part I and II) and remaining 10 subjects will be enrolled in~     cohort B. Subjects in cohort A (Part I) will receive dabrafenib 150 mg twice daily (BID) and~     subjects in cohort A (Part II) and Cohort B will receive combination of dabrafenib 150 mg~     BID and trametinib 2 mg once daily (QD). Study treatment will continue until disease~     progression, death or unacceptable toxicity. After disease progression, all enrolled~     subjects will be followed up for overall survival. The study will be completed after all~     subjects have died or surviving subjects have had at least 5 years of follow-up, whichever~     occurs first.~   "
46534|NCT02447926|"~     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control~     immune responsiveness to auto- and allo-antigens. However, there have been few efforts to~     harness the therapeutic potential of isolated Tregs to control graft rejection and inducing~     transplantation tolerance in solid organ recipients. In order for Tregs to be used as a~     clinical treatment, the following properties are necessary: ex vivo generation of sufficient~     numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress~     rejection in an alloantigen-specific manner, and survival/expansion after infusion. The and~     others have demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of~     these cells to down-regulate allogeneic immune responses in vitro, and 3) the efficacy of~     Treg for prevention of allograft rejection in animal models. In kidney transplant, the~     investigators have developed strategies for the ex vivo expansion of naturally occurring~     human Tregs (nTregs) from leukapheresis products that would allow for the clinical~     employment of this cellular therapy. The investigators are also interested in this approach~     in patients with end stage liver disease (ESLD) undergoing liver transplantation (LT). Our~     central hypothesis is that alloreactive human nTreg with suppressive action can be expanded~     ex vivo from ESLD patients (this proposal) and used to both prevent liver transplant~     rejection and facilitate the minimization and withdrawal of drug-based immunosuppression~     (future proposals). This application will further define and validate efficient methods for~     ex vivo expansion of human CD4+CD25+CD127- FOXP3+nTregs cells in ESLD. The investigators~     herein propose to use leukapheresis products obtained from patients with ESLD to further~     refine and optimize protocols for expansion of Tregs. Suppressive function of expanded cells~     will be assessed using in vitro assays of alloreactivity (mixed lymphocyte culture).~   "
46535|NCT02447913|"~     The proposed project will help in assessing the effectiveness of a demand-side financing~     project that provides family planning services bundled in a package of postnatal care and~     infant immunization services. This approach will use postnatal and infant health as a~     gateway to family planning - building confidence among the client and her influencers in the~     provider and repositioning family planning as part of a continuum of care to ensure the~     health of the mother and the infant. Vouchers will help in creating demand among poor women~     for the Family planning and child immunization. Also incentivizing providers against each~     voucher will help in improving their counselling skills as they will spend more time with~     voucher clients resulting is a satisfied client and better compliance with Family planning~     methods.~   "
46536|NCT02447900|"~     Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for~     image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with~     locally advanced non-small cell lung cancer (NSCLC)~   "
46537|NCT02447887|"~     This is a Phase I/II trial of the combination pegylated IFN-alpha 2b with ixazomib in~     metastatic renal cell carcinoma (mRCC). Researchers believe that by disabling the protein~     complex NF-kB, which controls the transfer of genetic information; using the study drug~     Ixazomib, they can promote necrotic cell death of RCC using interferon alpha - 2b. They~     hypothesize that the combination of ixazomib with IFN will lead to increased necrotic cell~     death in RCC tumors and consequent clinical benefit to patients.~      Patients will receive ixazomib capsules and pegylated IFN alfa 2b injection in this research~     study. Treatments will be given weekly and 4 weeks of treatment make up one cycle.~   "
46538|NCT02447874|"~     The purpose of this study is to determine whether giving extra arginine to patients with~     sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease~     pain scores, decrease need for pain medications or decrease length of hospital stay or~     emergency department visit.~   "
46539|NCT02447861|"~     The 3q29 deletion syndrome is caused by a deletion of a small part of human chromosome 3,~     and the duplication syndrome is caused by a duplication of this same small region. The~     purpose of this study is to understand the medical and behavioral consequences of these~     syndromes.~   "
46540|NCT02447848|"~     To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of~     moderate-to-severe acute pain in patients in an emergency room (ER) setting.~   "
46541|NCT02447835|"~     Within the past 20 years, there has been a striking increase in the incidence of obesity~     1;2, type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the~     schizophrenic population 6-8 . Large NIH-funded trials indicate that the prevalence of~     metabolic syndrome is twice to three times greater in schizophrenic patients on a specific~     class of drug termed the atypical antipsychotics (AAPs), of which olanzapine is an~     example, as compared to matched controls 8. Identification of the pathophysiological~     mechanisms contributing to metabolic disease in schizophrenic patients on AAPs has been~     hampered by the inability to differentiate underlying disease from treatment-emergent~     complications. In addition, despite falling within the same drug class, different AAPs~     exhibit differential associations with metabolic disease. Olanzapine is one of the AAPs~     associated with the greatest weight gain and degree of metabolic impairments.~   "
46542|NCT02447822|"~     This is a prospective randomized controlled study to evaluate feasibility and safety of~     early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney~     transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to~     either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within~     one week after kidney transplantation for all the patients. Maintenance immunosuppressants~     are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of~     biopsy-proven acute rejection, delayed graft function, graft loss or death within one year~     post transplant.~   "
46543|NCT02447809|"~     Clopidogrel is an important anti-platelet agent.However, about 30% of the coronary artery~     disease patients presented clopidogrel low response (CLR).Previous studies showed that the~     cardiovascular event ratio of the CLR patients was 4.4 times of the normal responders.~      It is known that the plasma and platelet miRNAs are determined by different disease status~     when platelets are released from the megakaryocyte, and the platelet miRNAs can adjust the~     expressions of the platelet's receptors and proteins.The purpose of this study is to find~     multiple platelet miRNAs involved in the development of CLR, and platelet miRNAs cause CLR~     through adjusting the expressions of the key receptors and proteins in the ADP activating~     pathway and consequently reducing their responses to clopidogrel.~      The CLR will be detected by light transmission aggregometry (LTA) and vasodilator-stimulated~     phosphoprotein phosphorylation (VASP-P). Differential expressions of plasma and platelet~     miRNAs profile in CLR patients will be screened by deep sequencing and validated to~     investigate the association between plasma and platelet miRNAs profile and CLR as well as~     the patients' prognosis.The study results would serve as markers for individualized~     anti-platelet treatment, and supply new targets for the treatment of coronary artery~     disease.~   "
46544|NCT02447796|"~     The investigators designed a prospective randomized study to compare the conventionally used~     sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with~     end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.~   "
46545|NCT02447783|"~     Flavanols are plant-derived compounds commonly present in the human diet. Examples of~     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,~     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been~     associated with improvements in cardiovascular health. In this study, the investigators hope~     to learn more about the effects of long term consumptions of cocoa flavanols on blood~     pressure, platelet function and other metabolic parameters in healthy humans. This study is~     a continuation of a previous study investigating the consumptions of increasing amounts of~     cocoa flavanols on blood pressure, platelet function and other metabolic parameters in~     healthy humans~   "
46546|NCT02447770|"~     Flavanols are plant-derived compounds commonly present in the human diet. Examples of~     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,~     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been~     associated with improvements in cardiovascular health. In this study, the investigators hope~     to learn more about the effects of the consumption of increasing amounts of cocoa flavanols~     on blood pressure, platelet function and other metabolic parameters in healthy humans. This~     study was followed by a second study that aimed at investigating the effects of long term~     consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic~     parameters in healthy humans.~   "
46547|NCT02447757|"~     Retrospective observational study to determine the efficacy of remifentanil during the~     delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100~     parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia~     induction) and parturients satisfaction with the method.~   "
46548|NCT02447744|"~     Childhood maltreatment is remarkably prevalent, and it has been shown to be associated with~     a wide spectrum of mental health problems, and it also been shown to be associated with~     smaller hippocampal volumes. This trial aims to see whether the 8-week mindfulness based~     stress reduction intervention can reduce the symptoms of depression, anxiety and PTSD for~     young adults with childhood maltreatment, and whether it can increase the hippocampal~     volumes.~   "
46550|NCT02447718|"~     This multi-center open label clinical trial aims to identify predictors of low antibody~     titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6~     months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular~     pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and~     13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months~     post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2~     months later. The results will support the development of clinical practice guidelines for~     this population.~   "
46551|NCT02447705|"~     Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to~     be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular~     filtration rate. This study is to see whether renal function is improved when Lamivudine is~     replaced by telbivudine in liver transplantation patients.~   "
46552|NCT02447692|"~     For adult patients with acute respiratory failure requiring invasive mechanical ventilation,~     does a ventilation strategy using proportional assist ventilation with load-adjustable gain~     factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a~     ventilation strategy using pressure support ventilation (PSV)?~   "
46553|NCT02447679|"~     This single-centered phase II clinical study is to obtain preliminary information on 1-year~     recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in~     combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore~     biomarkers(VEGF/bFGF) for thalidomide response.~   "
46554|NCT02447666|"~     Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic~     syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell~     transplantation (HSCT).~      Objectives Primary Objective The primary objective is to assess the treatment effect on~     response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR;~     JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at~     Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a~     matched-pairs analysis of historical data.~      Secondary Objective The secondary objective is to further evaluate safety, efficacy,~     pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.~      Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel~     experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on~     Simon's Optimal 2 stage study design. The sample size has been calculated to allow~     evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups.~     Each of the experimental arms will also individually be compared against a historical~     control arm using data retrospectively collected from the European Working Group of MDS in~     childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined~     subject baseline characteristics defined before any results from this study are known post~     Stage 1.~      Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie,~     subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at~     approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at~     the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a~     CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then~     enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or~     cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will~     be stopped.~   "
46555|NCT02447653|"~     The study design comprises a randomized trial of patients undergoing primary total hip~     arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular~     plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA~     scanning will be used to measure periprosthetic bone mineral density. Clinical evaluations~     will be conducted .~   "
46556|NCT02447640|"~     This is an open label study, non-randomized, positron emission tomography (PET)study~     investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in~     healthy subjects using [18F]-FPEB as the radiotracer.~   "
46557|NCT02447627|"~     The purpose of the study is to determine whether imaging techniques, such as magnetic~     resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging~     (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in~     different organ systems of participants with sickle cell disease (SCD). Differences in blood~     flow and oxygen levels detected by these techniques will be evaluated to determine their~     utility as biomarkers of clinical disease pathophysiology.~   "
46558|NCT02447614|"~     The study is designed to investigate the natural course of Primary snoring in 1-2 years or~     more and the different effect of drug and surgical treatment applied in children with~     obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires~     in 6 months after treatment.~   "
46559|NCT02447601|"~     To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by~     simvastation acid) in healthy subjects.~      To assess the safety of single doses of simvastation administered with and without PEX168~   "
46560|NCT02447588|"~     Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one~     of the first alternative treatment against infertility, although results in gestational~     terms are highly variable, ranging between 10% and 25%. The influence of progesterone levels~     in stimulated cycles of intrauterine insemination is an aspect little studied; however, this~     information may be useful when synchronizing the time of insemination with the implantation~     window, as it has been observed that patients with elevated levels of progesterone in the~     follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results~     being possible due to premature ovulation which causes asynchrony between the embryo and the~     endometrium.~      Taking into account these considerations, the aim of the investigators' study is to~     determine the effectiveness, in terms of ongoing pregnancy rates, to advance the~     intrauterine insemination with sperm donor (24 hours post-hCG) with respect to the standard~     schedule (36 hours post-hCG) according progesterone levels determined the day of hCG~     administration~   "
46561|NCT02447575|"~     Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices~     used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary~     disease. It is well-known that most patients do not use correct technique when using a~     metered dose inhaler. This leads to poor control of their disease. This study is being done~     so the investigators can record the patient using the metered dose inhaler before and after~     a short teaching session. This information will be fed into an invitro system (device) to~     allow the researchers to study the effect of error on drug delivery. The device being used~     is the Rice R3 electronic flowmeter.~   "
46587|NCT02447224|"~     The major goal of the project is to demonstrate the feasibility of conducting a multi-center~     randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of~     patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as~     to optimize the chance of a large multi-center clinical trial's future success.~   "
46562|NCT02447562|"~     Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a~     health platform NOMHADchronic, phone-based care group, usual care group) developed in the~     Valencia La Fe Health Department. 495 high-complexity chronic patients will be included~     according to a combined recruitment based on a risk predictive model plus clinical opinion.~     Patients will be followed-up during 12 months in order to evaluate health-related quality of~     life, mortality, health consumption, health direct cost and treatment satisfaction.~   "
46563|NCT02447549|"~     Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed~     in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the~     bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually~     treated either with surgical removal of the bladder, or daily radiotherapy treatment (high~     strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate~     methods which have the potential to improve how well this radiotherapy works.~      RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single~     UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout~     treatment and treats the whole bladder with the same radiotherapy dose. In adaptive~     radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused~     radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the~     bladder.~      In RAIDER, 240 participants with muscle invasive bladder cancer will be in one of 3~     treatment groups:~        1. standard whole bladder radiotherapy~        2. standard dose tumour focused adaptive radiotherapy~        3. dose escalated tumour boost adaptive radiotherapy~      Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after~     radiotherapy and annually thereafter to check whether the cancer has returned and to receive~     treatment for any symptoms they may be experiencing.~      RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher~     radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and~     to check that the long term side effects of the treatment are acceptable. If this is the~     case, results of RAIDER will be used to develop a study to establish whether dose escalated~     radiotherapy is better at treating bladder cancer than standard dose.~   "
46564|NCT02447536|"~     The investigators aim to conduct a randomised controlled trial comparing two Bacille~     Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian,~     in terms of prevention of neonatal and early life morbidity and mortality, immune responses~     and adverse events related to BCG vaccination. The primary outcome will be hospital~     admissions within 6 weeks of age.~   "
46565|NCT02447523|"~     Worldwide, the rising incidence of obesity has led to the identification of an obesity~     related syndrome, called metabolic. This syndrome is characterized by central obesity,~     hypertension, insulin resistance and altered lipid levels.~      Taking into consideration the rising incidence of obesity, anesthetists will more frequently~     encounter patients with metabolic syndrome, in their everyday practice. Moreover, the~     comorbidities that are related to the metabolic syndrome, increase the risk for~     perioperative complications. Therefore, strategies that will evaluate and modify the risk~     will be of great importance in the management of these patients, in order to maximize~     peri-anaesthetic and surgical safety.~      The aim of the study is to assess the incidence of metabolic syndrome and the impact of its~     presence on the outcome of patients undergoing elective laparotomy.~   "
46566|NCT02447510|"~     Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels~     which might be crucial to proper tissue repair and wound healing. However, the open usually~     contaminated nature of periodontal defects could affect negatively GF availability and~     activity. To test this assumption, this study was designed to evaluate levels of VEGF and~     PDGF-BB in gingival crevicular fluid (GCF) during the early stages of healing of localized~     intrabony defects treated with platelet rich in growth factor (PRGF) and platelet rich~     fibrin (PRF) as compared with xenograft defect filling control.~      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this~     prospective, randomized and single blinded trial. Each patient contributed one interproximal~     defect that was randomly assigned to the bone substitute grafting control (n=10) G1,~     experimental PRGF (n=10) G2 and PRF (n=10) G3. Plaque index, gingival index, probing depth~     (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were~     measured at baseline for patient enrollment. Gingival crevicular fluid (GCF) samples were~     collected on days 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome~     variable was the change in VEGF and PDGF-BB levels for sites treated by PRGF and PRF~     compared to that of the xenograft treated cases.~   "
46567|NCT02447497|"~     The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora~     of the abdominal and inguinal regions of human subject.~   "
46568|NCT02447484|"~     The purpose of this study is to determine whether a program of regular, theory-based text~     messages that encourages the message recipient to continue practicing safer sex (i.e., using~     condoms with sex partners) is effective in maintaining positive behavior change in women who~     have completed a brief safer-sex training.~   "
46569|NCT02447471|"~     Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm.~     This can be set to inflate every minute, but measurement may fail due to patient movement or~     shivering. Failed measurement occurs in up to 38% of patients.~      This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped~     around a finger - compares to standard BP measurement.~   "
46570|NCT02447458|"~     The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of~     MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy~     participants.~   "
46571|NCT02447445|"~     Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and~     function used in research and recommended as a simple inexpensive measure suitable for~     clinical use. Research has shown that low GS in hospital inpatients is associated with poor~     healthcare outcomes including increased postoperative complications, longer length of stay,~     increased functional limitations and disability. Measuring GS on admission to hospital has~     the potential to identify people at risk of poor healthcare outcomes allowing early~     intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely~     used in clinical practice. The aim of this study is to evaluate the implementation of GS~     measurement into routine clinical practice in Medicine for Older People wards at UHS.~   "
46600|NCT02447055|"~     The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma~     (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD~     (graft versus host disease). Specifically, the investigators will use the Flu/Mel~     (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins~     PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as~     both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in~     promoting the growth of myeloma cells and progression of disease.~   "
46572|NCT02447432|"~     The primary aim of the study is to demonstrate that an investigational 4-dose presentation~     of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of~     Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal~     serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first~     secondary objective), after administration of a 3-dose primary vaccination course at 6, 10~     and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at~     6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI)~     schedule).~      In addition, the study will also assess the safety, reactogenicity, immunogenicity and~     antibody persistence (approximately 7 months following primary vaccination) of the 4-dose~     presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and~     18 weeks of age followed by a booster dose at 38 weeks.~      This study also aims at assessing the safety, reactogenicity and immunogenicity of the~     4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately~     9 months of age.~   "
46573|NCT02447419|"~     This study is a single-arm,phase II study of gefitinib in patient with epidermal growth~     factor receptor amplification Refractory solid tumors.~      Gefitinib 250 mg will be administered orally daily.~      To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor~     receptor amplification Refractory solid tumors.~   "
46574|NCT02447406|"~     Phase Ib/II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in~     advanced gastric adenocarcinoma patients with MET amplification as a second-line treatment.~      Phase Ib:Investigational product, dosage and mode of administration Volitinib is an orally~     available, potent, selective, small molecule c-MET inhibitor.~      Volitinib should be administered at least 200mg orally once a day in 21 days for achieving~     appropriate antitumor activity.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks Phase II:~     Investigational product, dosage and mode of administration Volitinib is an orally available,~     potent, selective, small molecule c-MET inhibitor. Subjects will receive Volitinib once~     daily ( at the MTD determined from Phase Ib) for 21 days as one cycle.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.~   "
46575|NCT02447393|"~     This is a single center, single blind, single dose, randomized, partial cross-over study to~     confirm bioequivalence between levocetirizine and cetirizine.~   "
46576|NCT02447380|"~     Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced~     gastric adenocarcinoma patients with MET overexpression as a second-line treatment.~      Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor.~      Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days~     as one cycle.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.~      To investigate the efficacy of volitinib when given in combination with docetaxel in~     patients with advanced gastric adenocarcinoma harboring MET overexpression.~   "
46577|NCT02447367|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Solifenacin and Tamsulosin in healthy male volunteers.~   "
46578|NCT02447341|"~     This is a national, multicenter, cross-sectional, observational study within a convenience~     sample of Internal Medicine departments from 100 hospitals in Spain which agree to~     participate in the study. This study will be a cross-sectional chart review which will~     require the collection of data from medical records and from face-to-face interviews~     conducted during the inclusion visit. Physician interviews are needed to collect three~     variables of interest, recommended by the Spanish Society of Internal Medicine as necessary~     data about profile and management of NVAF patients: cognitive deterioration based on the~     patient's responses, physician's assessment of the patient's life expectancy, and~     physician's opinion of the antithrombotic treatment previously prescribed. The investigators~     will only provide their opinion on previously prescribed therapies (i.e. prescribed before~     F2F). Hospitals to be contacted for the study include those known to participate in~     observational studies in Spain; the hospitals will therefore not be a random sample of~     Spanish hospitals.~   "
46579|NCT02447328|"~     This single-arm study aims to assess the safety and tolerability profile of~     Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally~     advanced or metastatic breast cancer. The primary objective is to evaluate the adverse~     events after Fulvestrant (Faslodex®) for about 6 months~   "
46580|NCT02447315|"~     The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of~     pilocarpine on salivary secretion in healthy male and female subjects. In addition,~     pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics~     and safety and tolerability of oral doses of pilocarpine in healthy subjects.~   "
46581|NCT02447302|"~     The purpose of this study is to determine whether APD334 is a safe and effective treatment~     for ulcerative colitis.~   "
46582|NCT02447289|"~     Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives;~     masked, controlled, parallel design with three arms, phase 4.~   "
46583|NCT02447276|"~     The primary objective of this study is to evaluate the effectiveness of REGN475 compared to~     placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a~     history of inadequate joint pain relief or intolerance to current analgesic therapy.~   "
46584|NCT02447263|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere~     interventional therapy using digital subtraction angiography（DSA） for liver cancer.~   "
46585|NCT02447250|"~     The purpose of this study is to help determine the best dose of albuterol in premature~     babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung~     disease of prematurity and is associated with increased morbidity and mortality, longer~     hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication~     frequently used in premature infants with chronic lung disease and in people with asthma. It~     is believed to be safe, but the optimal dose for infants is not clear. The investigators~     hypothesize that albuterol may help a subset of premature infants with lung disease, but~     they need to determine the best dose prior to doing research about how effective it is for~     chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using~     pulmonary function tests.~   "
46586|NCT02447237|"~     The study investigates the effect of liquid food on the intake of energy and protein~     compared to solid food. One group will receive dietary counselling in fulfilling their need~     for energy and protein from liquid food and the other group from solid food.~   "
46588|NCT02447211|"~     Radiation dermatitis is one of the most common side effects of radiotherapy approximately~     occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural~     tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear~     and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and~     dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to~     pain and discomfort has an adverse impact on the quality of a patient's life.The radiation~     toxicities such as radiation dermatitis encountered in clinical practice are typically~     managed with a variety of topical agents such as water-based moisturizing creams or lotions,~     topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic~     interventions for the prevention and treatment of these toxicity can be used to protect skin~     against radiation damage.Currently, there is no standard treatment for the prevention of~     radiation-induced dermatitis with demonstrated effectiveness.The aim of this randomized,~     double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin~     for the prevention and management of radiation-induced dermatitis during postoperative~     radiotherapy for breast cancer.~   "
46589|NCT02447198|"~     Legislation to allow medical marijuana has had a significant impact on the pediatric~     population of Colorado. There have been many reported different effects and properties of~     each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics~     have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content~     hash oil in children with epilepsy. The reported benefit of this oil is to have the~     anticonvulsant properties of CBD without the psychoactive components of THC. Human studies~     on the efficacy of CBD on epilepsy are few and limited.~      The investigators' specific aims are the following:~        -  Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD),~          Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with~          epilepsy.~        -  Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs~          (AEDs) taken in conjunction with CBD in order to evaluate drug interactions.~        -  Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy.~      The investigators will recruit children and their parents who are currently using or plan to~     use CBD for their seizure disorder. This study will NOT be providing patients with CBD.~     Consenting subjects will undergo a number of blood and urine collection that will be~     analyzed to describe the pharmacokinetics and possible drug interactions of CBD in pediatric~     epilepsy.~   "
46590|NCT02447185|"~     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic~     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth~     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.~   "
46591|NCT02447172|"~     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3~     parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be~     randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard~     ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application~     of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for~     approximately 28 days and return to the clinic weekly for safety and efficacy assessments.~     After completing treatment, patients will return to the clinic for scheduled follow-up~     visits approximately 10, 30, 60 and 90 days after treatment is stopped.~   "
46592|NCT02447159|"~     A randomized controlled trial will be conducted to assess the effectiveness of conditional~     cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission~     (PMTCT) services specifically, in relation to pickup of ARV drugs for infected mothers,~     delivery in the hospital setting, and receipt of drugs for exposed infants. Administrative~     data will be extracted from the All Babies are Equal program and hospital records. At 8-10~     weeks after delivery, an endline survey will also be conducted with each participant to~     provide a deeper understanding of the impact of the CCTs and to assess the reasons for~     retention in PMTCT services.~   "
46593|NCT02447146|"~     This is a controlled trial to assess the effects of resistance training on bradykinesia and~     physical function in patients with Parkinson's Disease. Forty patients diagnosed with~     Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were~     allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the~     Control Group attended lectures on the disease.~   "
46594|NCT02447133|"~     The objective of this study is to validate the TopQ cutoff scores, which have been~     previously determined.~   "
46595|NCT02447120|"~     The objective of this study is to collect OCT measurement data on normal healthy eyes in~     order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile~     points for 1%, 5%, 95%, and 99%.~   "
46596|NCT02447107|"~     Mobile technology can be used to passively capture data tracing features and fluctuations of~     patients' daily activities, including activity levels, location patterns, sleep, and a wide~     variety of other health-relevant metrics. This data can then be combined with contextual~     recall, collected through a mobile app, to enhance passively captured behavioral data. The~     resulting data collection is objective, real-time, and contextual, thus addressing the~     pitfalls of conventional measurement of pain treatment outcomes.~   "
46597|NCT02447094|"~     To study the effect of a telemedicine model of stroke care on patient-based outcomes.~   "
46598|NCT02447081|"~     This will be a prospective, multicenter, observational, non-randomized study to compile real~     world outcome data on the use of the Amulet™device in non-valvular atrial fibrillation~     (NVAF) subjects. The study is designed to follow the Instructions For Use (IFU) to gather~     data on the implant procedure through two years of follow up with the Amulet™ device in a~     commercial clinical setting.~   "
46599|NCT02447068|"~     This is a proof of concept, investigator blinded study to evaluate the efficacy and safety~     of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive~     dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms~     will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to~     the light alone and to dressing alone and no treatment. Ten patients will be enrolled in~     this 6 weeks study.~   "
46703|NCT02445716|"~     This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75~     years, with treatment-emergent loss of libido will be randomly allocated to the treatment~     with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of~     testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.~   "
46601|NCT02447042|"~     The administration of fluids intravenously is the first step in the stabilization of~     patients in septic shock. It is important to give the right dose of fluids, enough to~     improve the function of the cardiovascular system but not too much to drown the cells in~     water. In order to know that, the investigators use the fluid challenge which is the~     administration of a small amount of fluid in a short period of time in order to test the~     cardiovascular response to a dose of fluids. However, it is unclear how small this amount~     can be. The aim of this study is to find out the minimum volume required to perform an~     effective fluid challenge. The investigators hypothesize that the changes in the mean~     pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf)~     during the administration of small amounts of fluid can be used to detect the minimum volume~     required to effectively test the cardiovascular system with a fluid challenge.~      On the other hand, microcirculation may remain impaired despite the stabilization of the~     macrocirculation. The microcirculation can be much more dynamic than the macrocriculation,~     so it is essential to observe the changes of both over time. Patients admitted at the~     investigators' intensive care unit (ICU) due to sepsis can be included in this study. The~     sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg,~     3 ml/kg, 4ml/Kg and 5 ml/kg.~      The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated~     during one minute. Invasive arterial blood pressure will be observed during the inflation of~     the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this~     method is 14%. The minimal volume will be that one that achieve that change in Pmsf.~   "
46602|NCT02447029|"~     Despite global efforts to decrease discomfort during surgical abortion, pain remains a~     limiting factor in where and how procedures are performed. Several studies have investigated~     different methods of delivering cervical anesthesia prior to abortion, however to the best~     of the investigators' knowledge, there is no published data that 1) rigorously examines the~     effect of a time interval between local anesthetic administration and procedure initiation,~     or 2) explores whether adequate pain relief is possible through self-administered,~     non-invasive means alone. Research in this area has a significant public health impact,~     given the large number of women worldwide who seek abortions.~      The investigators propose to explore the effect of a locally applied vaginal lidocaine gel~     in place of the traditional paracervical block prior to first trimester surgical abortion.~     They hypothesize that lidocaine gel is no worse than paracervical block at decreasing~     abortion related pain at a variety of time points throughout the procedure. This is a~     non-inferiority, open label, randomized controlled trial.~      If self-administered vaginal gel is acceptable and effective, it would increase options for~     pain control during abortion and other gynecologic procedures.~   "
46603|NCT02447016|"~     The aim of this prospective, open label study is to check for differences in~     neuropsychiatric and neurocognitive measurements among patients that will be switched from~     Atripla to Eviplera among 40 patients.~   "
46604|NCT02447003|"~     This is a two-part study of pembrolizumab monotherapy in participants with metastatic~     triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and~     safety of pembrolizumab monotherapy as first line or above treatment. Part 2 of the study,~     if done, will expand the investigation of pembrolizumab treatment in a subgroup of~     participants from Part 1 and will only start after enrollment in Part 1 has been completed.~   "
46605|NCT02446990|"~     The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events~     in patients with coronary artery disease.~   "
46606|NCT02446977|"~     Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke~     to know if it causes a reduction of glutamate-mediated excitotoxicity.~   "
46607|NCT02446964|"~     This phase I trial studies the side effects and best dose of total bone marrow and lymphoid~     irradiation when given together with chemotherapy before donor stem cell transplant in~     treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid~     irradiation is a type of radiation therapy that targets bone marrow and blood, where the~     cancer is, instead of applying radiation to the whole body. Stem cell transplants use high~     doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation,~     to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy,~     healthy cells from a donor are given to the patient to help the patient grow new blood~     cells.~   "
46608|NCT02446951|"~     Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known~     as hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal~     production with problems eliminating it from the body. Serum levels of bilirubin in excess~     of 5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience~     these levels within the first week of life. For those patients who have markedly elevated~     serum bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange~     transfusions is a viable option within the hospital setting. In comparison, bili-blankets~     have been used as a form of phototherapy for those patients being treated in a home-based~     setting to reduce the likelihood of hospital readmissions.~   "
46609|NCT02446938|"~     Transpulmonary pressure is frequently monitored in patients with mechanical ventilation.~     Right position of the catheter balloon is the key factor in accurate measurement. A simple~     method for confirming the balloon position will be validate in this study.~   "
46610|NCT02446925|"~     The Surefire Infusion System is a novel catheter initially developed to prevent reflux of~     embolic material into non-target vascular territories. Further research has demonstrated~     improved penetration and distribution of embolic material into treated arterial territories.~     The purpose of this study is to compare Y-90 glass microsphere distribution and penetration~     into cancerous tissue within the liver between a standard endhole catheter and the Surefire~     Infusion System.~   "
46611|NCT02446912|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to~     severely active, autoantibody-positive systemic lupus erythematosus (SLE).~   "
46612|NCT02446899|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of anifrolumab versus placebo in adult subjects with moderately to severely active,~     autoantibody-positive systemic lupus erythematosus (SLE).~   "
46613|NCT02446886|"~     The primary objective of this study is to determine if monthly pulse doses of a three-day~     course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured~     by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course~     of treatment.~      The main secondary objective is to utilize every three month MWF measurements to determine~     the peak time of remyelination in new multiple sclerosis lesions when followed over the~     course of 12 months.~   "
46614|NCT02446873|"~     The proposed study will fill an important gap in the literature by examining, through a~     randomized controlled trial, the effect of egg consumption on biochemical markers of~     choline, vitamin B-12, lipids, and amino acids in young children in a poor rural area of~     Ecuador. Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two~     groups: 1) intervention, receiving one egg per day for six months; or 2) control. Baseline~     and endline data on socio-economic factors, and child diet, morbidities, and anthropometry~     will be collected. Blood will also be drawn from the children at these time points for~     nutrient biomarker analyses. Through qualitative research the proposed study will provide~     insight into the attitudes, beliefs, and use of eggs by mothers and other caregivers during~     the complementary feeding period. The University of San Francisco in Quito (USFQ) will be~     the lead field coordinator of the research working in partnership with Washington University~     in St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.~   "
46615|NCT02446860|"~     Single arm, open label, phase II trial. Participants to undergo biopsy of primary tumour~     followed by 8 weeks of nivolumab therapy followed by nephrectomy. Nivolumab to be continued~     post-operatively~   "
46616|NCT02446847|"~     This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying~     rebound of viral load during a brief treatment interruption of standard ART and its safety~     during a brief analytical interruption of antiretroviral therapy.~   "
46617|NCT02446834|"~     Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor~     Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their~     metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism~     of intensive lifestyle intervention to PCOS.~   "
46618|NCT02446821|"~     Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the~     effectiveness, device placement, safety, and tolerability of VeraCept to support commencing~     a Phase III Clinical Study~   "
46619|NCT02446808|"~     The purpose of this study is to determine whether the use of intraoperative nerve monitoring~     during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary~     continence and erectile function.~   "
46620|NCT02446795|"~     Advanced renal cell carcinoma is invariably fatal, with a life expectancy of 2-3 years since~     diagnosis. Sunitinib is the standard first-line treatment for this condition, but it is~     associated to multiple side effects, with fatigue being reported in 51-63% of patients. As~     sunitinib-induced fatigue is likely to be mediated by inhibition of AMPk function, the~     investigators hypothesize that isoquercetin, which is hydrolyzed in vivo to quercetin, a~     known AMPk activator, is able to reduce fatigue in kidney cancer patients taking sunitinib.~   "
46621|NCT02446782|"~     This is a prospective study to assess the efficacy and safety of a single dose of cefazolin~     2g IV for the prophylaxis of surgical site and pleural space infections in patients~     undergoing medical thoracoscopy.~   "
46622|NCT02446769|"~     This is a multicenter, randomized, parallel-group, open label study of the efficacy of~     AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD.~   "
46623|NCT02446756|"~     To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on~     cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two~     random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was~     used to evaluate the motor function of knee joints, followed by magnetic resonance imaging~     (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.~   "
46624|NCT02446743|"~     The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years~     after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV~     NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and~     V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination~     with rMenB+OMV NZ~   "
46625|NCT02446730|"~     The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose~     (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent~     percutaneous coronary intervention (PCI) with BiomatrixTM stent.~   "
46626|NCT02446717|"~     The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with~     or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection~     who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.~   "
46627|NCT02446704|"~     This research study is evaluating the combination of olaparib and temozolomide as a possible~     treatment for Small Cell Lung Cancer.~   "
46628|NCT02446691|"~     This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian~     will be provided information about the trial. If interested and if eligible, they will then~     be asked to provide signed informed consent. The initial study visit can occur immediately~     after signed informed consent has been obtained. Approximately 135 subjects will be enrolled~     to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.~   "
46636|NCT02446587|"~     SELECT is a multicenter, observational prospective study implementing a protocol to acquire~     imaging and clinical variables known to affect clinical outcomes after endovascular therapy~     in an effort to evaluate and compare the different selection methods and criteria currently~     used in practice for acute ischemic stroke patients in the anterior circulation with large~     vessel occlusion. The study aim is to evaluate prospectively different selection~     methodologies for endovascular therapy, to compare them against each other to identify which~     method provides the highest predictive ability in the selection of patients for IAT and to~     devise a formula that predicts patients' outcomes.~      This study will enroll patients based on the recent AHA guidelines (July 2015) regarding~     treatment of patients with acute ischemic strokes and large artery occlusions in the~     anterior circulation.~   "
46637|NCT02446574|"~     This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with~     radiation therapy, and to document the adverse events for further clinical trial.~   "
46629|NCT02446678|"~     Background~        -  Patients presented to hospital with coffee ground vomiting and black stool may not be~          actually having upper gastrointestinal bleeding (UGIB)~        -  Hospital admission can be avoided if serious UGIB can be excluded~        -  To date, the only useful tool to triage patient for hospital admission in UGIB is by~          using clinical score such as Rockall score or Blatchford score~        -  These scores are cumbersome and only exclude the most benign cases, but they are not~          useful in differentiating those who needs intervention~        -  In our pilot study, investigators found that capsule endoscopy can be used to identify~          patients with fresh blood and real coffee ground substance in the stomach and it is~          superior to nasogastric tube~        -  Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy~      Objectives The current study is designed~        1. to validate capsule endoscopy is an effective method in identifying patients with UGIB~        2. to study whether the capsule endoscopy can reduce requirement of hospital admission in~          patients with suspected UGIB~        3. to study if capsule endoscopy can help to identify patients with UGIB that may require~          urgent (within 24 hours) endoscopy and intervention~        4. to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in~          the management of UGIB~        5. to compare the effectiveness of capsule endoscopy against Blatchford score in~          identifying patients with UGIB that may require endoscopic intervention.~   "
46630|NCT02446665|"~     Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver~     cirrhosis, liver failure and liver cancer. Assessment of disease status is important to~     determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of~     an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has~     been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of~     liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be~     utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker~     for monitoring disease status in PSC. Successful outcomes will provide an opportunity for~     optimal treatment triage including liver transplantation via accurate and non-invasive~     estimation of true disease status in PSC.~   "
46631|NCT02446652|"~     The purpose of this study is to determine the efficacy and safety the combination of~     TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with~     recurrent-persistent cervical cancer.~   "
46632|NCT02446639|"~     Troponin T (TnT) is a component of the contractile apparatus of the striated musculature.~     Although the function of TnT is the same in all striated muscles found in the heart to form~     a TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high~     tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial~     injury.~      Asymptomatic elevations of troponins is frequently found in patients with chronic renal~     failure in stage V, which present no clinical signs of acute or electrical myocardial~     injury.~      Many studies have been conducted in recent years to explain the origin and clinical~     significance of this elevation, but the results are controversial: cardiac dysfunction, left~     ventricular hypertrophy or chronic inflammation.~      Besides the effect of the dialysis session was evaluated on this biological parameter in~     different studies which together do not find Impact hemodialysis session on the value of~     troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population,~     will:~        -  to determine the evolution of TnT in time and what are the characteristics of the~          patients for whom this rate varies~        -  to know what its evolution during the session,~        -  to identify if possible the criteria that are responsible for the variation in the~          direction of increasing and / or its reduction~        -  and to characterize patients whose base rate is higher than the 99 percentile in the~          absence of clinical symptoms which could lead to establish reference population for~          this specific normal values. The Purpose of this study is to evaluate the serum~          troponin T in a hypersensitive dialysis population and verify what is the influence of~          the hemodialysis session, the session parameters and intradialytic events on changes in~          serum troponin T hypersensitive after a hemodialysis session. ~   "
46633|NCT02446626|"~     Background:~      The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia~     burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases~     of Lyme disease are cured by antibiotics, but some patients continue to experience symptoms~     despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the~     presence of a disease-causing microbe.. Researchers will use live, laboratory-bred ticks to~     see if Lyme disease bacteria can be detected in people after completing antibiotic therapy~     and if that is more common in people who continue to experience symptoms such as fatigue and~     joint pain.~      <TAB>~      Objectives:~      - To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease~     and received antibiotic therapy and if it correlates with persistent symptoms.~      Eligibility:~        -  Adults at least 18 years old who have:~        -  Untreated erythema migrans (the Lyme disease rash); OR~        -  Untreated Lyme arthritis; OR~        -  Continuing symptoms after treatment for Lyme disease; OR~        -  Had Lyme disease and antibiotic treatment within the past 12 months.~        -  Healthy volunteers~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Visit 1:~        -  Blood and urine tests, health questionnaire.~        -  Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed)~          will be placed under a dressing.~        -  Participants may have two small biopsies of skin .~        -  4 6 days later, Visit 2:~        -  Dressing will be removed and ticks will be collected.~        -  Participants will answer symptom questions.~        -  If many ticks are still attached, participants will have to come back the next day. If~          not enough ticks feed successfully, the procedure may be repeated.~        -  Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be~          return to the clinic 3 times to see how they feel and answer questionnaires. Test~          results will be discussed.~   "
46634|NCT02446613|"~     This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by~     repeating a nasal allergen challenge (NAC) approximately one year after treatment in~     subjects from TL7116958. This is a single centre, single period study in subjects with~     respiratory allergy/allergies who completed the study TL7116958 in 2014 to investigate the~     long term effect of previous treatment with GSK2245035 compared with placebo on total nasal~     symptoms elicited by nasal allergen challenge. Subjects and staff will remain blinded to the~     treatment received in the TL7116958 study (GSK2245035 or placebo). The study will consist of~     a screening visit to assess eligibility criteria, a study period consisting of a single~     visit when the nasal allergen challenge will be performed, and follow up by phone or a~     clinic visit at the discretion of the investigator 4-7 days following the allergen~     challenge. Eligible subjects will participate in this study for approximately70 days total~     from screening to follow up.~   "
46635|NCT02446600|"~     This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see~     how well they work compared with standard platinum-based chemotherapy in treating patients~     with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come~     back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian,~     fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels~     necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel,~     gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether olaparib~     or cediranib maleate and olaparib is more effective than standard platinum-based~     chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or~     primary peritoneal cancer.~   "
46639|NCT02446548|"~     The study is a randomised, double-blind, controlled 2 x 3 cross-over trial in which the~     renal effects of therapy with aliskiren (A), placebo (P) and losartan (L) will be compared.~     It consists of an 8-week run-in period, 8 weeks of active treatment with aliskiren or~     losartan (period 1), 8 weeks of active treatment with the alternative medication (period 2),~     and an 8-week placebo administration between them.~   "
46640|NCT02446535|"~     Background Very recently, a test aimed at assessing dry weight (DW) in hemodialysis (HD)~     patients has been developed, the resistance stabilization test (REST)~      Aim of the study To verify if BIA-based DW (BIA DW) control is truly superior to current~     volume management in HD patients.~      Protocol of the study DW determined with clinical methods (Clinical DW) is the gold standard~     by definition: Clinical DW is determined under strict clinical surveillance by the same~     attending physician. He will be helped by a clinical score of volume state about symptoms~     and signs of hypo- or hypervolemia. The physician is asked to adjust the DW of the~     candidates until their clinical score reaches zero before the BIA measurement. This Clinical~     DW will be compared with BIA DW, as obtained after performing REST~      Phases of the study~      The protocol study includes three sequential phases:~        1. the Clinical DW is the gold standard by definition. Items of form B must be strictly~          applied until score = 0 is achieved;~        2. The Clinical DW as indicated by the score = 0 becomes the target DW of the next~          standard HD session, in which BIA measurements are performed: R values are recorded~          continuously during the session.~        3. REST is performed the following dialysis session. As per protocol, these dialysis~          sessions may be one or more than one, until flattening of the curve of the ratio R0/Rt~          (R0 is R at time 0 and Rt is R at a given time t during the HD session) of less than +~          1% over 20 minutes in the presence of ongoing UF, is obtained.~      Primary outcome~      The primary outcome is the definition for each patient of the gold standard DW when~     comparing the Clinical and the BIA DW. Two are the possible scenarios:~        1. the Clinical and the BIA DW will be very similar ( < + 0.5 kg). Therefore, a reciprocal~          validation of the two methods for that specific patient has been obtained;~        2. the Clinical and the BIA DW are different ( > + 0.5 kg). If the BIA DW will be~          confirmed in the following six dialysis sessions, it means that the gold standard DW~          for that patient is the BIA DW.~   "
46641|NCT02446522|"~     There is no shared vision relating to integrity and quality of the conduit after the impact~     on the vein wall during vein harvesting. In this connection, the investigators studied the~     initial state of the venous conduit, interoperation damages of the vein and postoperative~     wound complications while using two methods of GSV harvesting.~   "
46642|NCT02446509|"~     Bipolar disorder is a debilitating chronic illness characterized by periods of elation and~     depression. Since deinstitutionalization of the mentally ill over 40 years ago, families~     have become major caregivers for patients with bipolar disorder . This illness imposes a~     substantial and chronic burden on family caregivers Despite their persistent stress and~     burden, these caregivers have been largely ignored. Interventions to help them have been~     very limited. One comprehensive intervention was developed and implemented by Miklowitz~     (2008) and has shown to be effective in reducing caregiver depression and improving health~     outcomes. However, this intervention and is highly complex, long, and was given on an~     individual basis, significantly raising the cost of the program. One core component of the~     Miklowitz (2008) intervention is psychoeducation, which provides the fundamental support and~     information needed to caregivers on an individual basis.~      In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions.~     After completion of these sessions in the intervention group, the wait list control group~     will receive the same weekly sessions. In this study, the investigators plan to test the~     feasibility and potential efficacy of this specific psychoeducation intervention implemented~     in a group setting. The investigators will also examine the effects of this psychosocial~     intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health~     outcomes.~      The specific aims are to:~        1. Test the feasibility of implementing a 7-week group psychoeducation program for family~          caregivers of patients with bipolar disorder by assessing recruitment and retention~          rates, attendance, satisfaction with the program, and data and sample collection rate.~        2. Explore the effect of the intervention on caregiver outcomes (depression, burden,~          health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.~      The intervention will be delivered by at the University of Texas Health Science Center at~     Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health~     Science Center at Houston School of Nursing. Forty family caregivers of patients with~     bipolar disorder will be recruited into the study.~   "
46643|NCT02446496|"~     This is an open-label, randomized, single dose, two-sequence two-period crossover study,~     separated by 7 days washout interval from the first Study Drug Administration. This study is~     conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets~     manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and~     cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind.~     Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy~     adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive~     cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,~     subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not~     receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a~     trademark of Sandoz.~   "
46644|NCT02446483|"~     This is an open-label, randomized, single dose, two-sequence, two-period crossover study,~     separated by 7 days washout interval from the first study drug administration.~      In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed~     release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of~     each to healthy adults under fasting conditions, will be investigated by determining the 90%~     confidence limits for the log-transformed ratio (Test product / Reference product) for the~     bioequivalence parameters. The influence of sequence, product and period effect will be~     tested by analysis of variance (ANOVA).~      In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split~     into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will~     be done and the volume of blood will not exceed 300 milliliters (mL) for the study.~      PARIET is a registered trademark of EISAI Co. Limited.~   "
46645|NCT02446470|"~     This study is a prospective, randomized controlled trial comparing the sinus tarsi approach~     to the extensile lateral approach for surgical fixation of calcaneus fractures.~      It is hypothesized that open reduction and internal fixation of intra-articular calcaneus~     fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable~     fixation with significantly decreased wound complication rates in comparison to an extensile~     lateral approach.~   "
46646|NCT02446457|"~     The goal of this clinical research study is to learn if the combination of pembrolizumab and~     rituximab can help to control relapsed FL. The safety of this combination will also be~     studied.~   "
46647|NCT02446444|"~     The purpose of this study is to determine the effectiveness of enzalutamide as part of~     adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone~     analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk~     of recurrence.~   "
46648|NCT02446431|"~     Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy~     and complete treatment in remission. High-risk patients however, frequently have recurrent~     disease which is then treated with ad hoc regimens or early phase therapies with little~     benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug~     exposure, has been successfully tested in pediatric leukemias with excellent results in~     terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors~     with little success, but has been implemented usually in the relapsed setting at a time of~     high tumor burden and disease resistance.~   "
46649|NCT02446418|"~     The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a~     once-daily combination therapy for the long-term maintenance treatment of asthma in adults~     and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and~     efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised~     clinical trials tend to be highly controlled and enrol a more highly selected subject~     population than is expected to be prescribed the medication post-approval. There is a need~     for data in a more representative population in close to a 'real life' conditions, where~     physicians have the ability to choose the best treatment in their view for any individual~     subject and adapt treatments to subjects' characteristics and response. This multi-center,~     open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI~     compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S]~     or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a close to real~     life settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler~     (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™~     DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total~     duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and~     DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered~     trademark of AstraZeneca.~   "
46650|NCT02446405|"~     The purpose of this study is to determine the effectiveness of enzalutamide, versus a~     conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone~     releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation~     therapy (ADT) for newly diagnosed metastatic prostate cancer.~   "
46651|NCT02446392|"~     In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are~     included with the aim to investigate the potential underdosing in this patient group. Four~     regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken~     before the next dose is administered for three consecutive days.~   "
46652|NCT02446379|"~     This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in~     detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.~      EnLightTM will be used to detect positron emission and the LightPathTM system to detect~     Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent.~      The study will also evaluate the patient safety and radiation safety of the EnLightTM, and~     the safety for the device operators and surgical staff of the LightPathTM Imaging System.~   "
46653|NCT02446366|"~     This phase I trial studies the side effects and the best dose of hypofractionated~     stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that~     was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy~     over a shorter period of time and may kill more tumor cells and may have fewer side effects~     than standard radiation therapy.~   "
46654|NCT02446353|"~     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and~     Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.~   "
46655|NCT02446340|"~     The purpose of this study is to examine safety outcomes in healthy volunteers after systemic~     administration of multiple ascending doses of dalazatide.~   "
46656|NCT02446327|"~     The main objective is to replicate the validation of omics biomarkers of left ventricular~     diastolic dysfunction in patients with metabolic syndrome.~      The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625~     patients were enrolled in Europe and 47 in France.~   "
46657|NCT02446314|"~     The purpose of this study is to determine whether a 6 month dietary intervention with wild~     blueberry powder and extract stabilised with L-cysteine and L-glutathione have an effect on~     cognitive performance in participants aged between 65 - 80.~   "
46658|NCT02446301|"~     This study is to evaluate the relative bioavailability of nalbuphine after single IM~     injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM~     injection in healthy volunteers.~   "
46659|NCT02446288|"~     The study is an open-label, prospective, multicenter, randomized, two treatment parallel,~     comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal~     bruxism episodes in subjects diagnosed with sleep bruxism.~   "
46660|NCT02446275|"~     Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory~     manual therapy treatment in migraine compared to treatment based on Myofascial Trigger~     Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.~      Material and methods: 27 patients in two groups participated in the study: a) the control~     group received combined techniques based on MTrPs and bilateral stretching in the trapezius~     and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same~     techniques as those applied in the control group plus suboccipital inhibition. The treatment~     lasted for 8 weeks and the impact, disability and quality of life were assessed in both~     groups.~   "
46661|NCT02446262|"~     Background:~      - Painful stimuli cause changes in a network of brain regions called the Pain Matrix. But~     most of these regions respond to many other stimuli, not just pain. Researchers want to~     understand how different factors influence pain. They want to test what happens when people~     expect different levels of pain and receive treatments that can modify pain. They want to~     see if these factors influence decisions about pain and how the body responds to it. They~     also want to compare pain with responses like taste and vision.~      Objectives:~      - To better understand how pain and emotions are processed and influenced by psychological~     factors.~      Eligibility:~      - Healthy volunteers ages 18 50.~      Design:~        -  This study requires 1 to 2 clinic visits that last 1 to 3 hours.~        -  Participants will be screened with medical history and physical exam.~        -  Some participants will have one or more magnetic resonance imaging (MRI) scans of their~          brain. For MRI, participants will lie on a table that slides in and out of a cylinder.~          The scanner makes loud knocking noises. They will get earplugs.~        -  Participants heart activity will be recorded with electrocardiogram. Their pulse,~          sweating, and breathing will be monitored.~        -  Some participants will take a taste test. Others may perform simple tasks. Others may~          receive pain in their arm, leg, or hand. The pain will come from heat or electric~          shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests~          may be given during MRI.~        -  Participants will fill out questionnaires.~        -  The study will last 3 years.~   "
46662|NCT02446249|"~     Background:~      - Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can~     cause problems like infections and tooth decay. Researchers hope a new drug can help people~     with dry mouth caused by radiation.~      Objectives:~      - To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in~     people whose parotid glands have had radiation.~      Eligibility:~      - People at least 18 years of age with a history of radiation therapy for head and neck~     cancer.~      Design:~        -  Participants will be screened in 2 visits with:~        -  medical history~        -  physical exam~        -  scans~        -  saliva collections~        -  sialogram. A substance is injected in the parotid gland and X-rays are taken.~        -  non-drug infusion~        -  IV dose of glycopyrrolate to stop saliva~        -  3-day hospital stay: Participants will get the gene infusion. The AAV2hAQP1 will be in~          a solution in a syringe. It will be slowly pushed through an opening into the gland~          inside your mouth..~        -  10 outpatient visits over 3 years. These may include:~        -  repeats of screening tests~        -  blood and urine tests~        -  oral and head and neck exams, including a thin scope in the airway~        -  questionnaires~        -  small piece of skin taken~        -  small piece of tumor tissue taken by either:~        -  a small video-scope in the parotid duct that also takes pictures~        -  or by a small needle guided by ultrasound~        -  scans. Participants lie in a machine or a scanner The machine may feel close to the~          body or face. . For some, a substance will be injected in a vein or put in the~          mouth.<TAB>~        -  Participants will keep a diary about how they feel before and after the therapy.~   "
46663|NCT02446236|"~     This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib~     (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell~     lymphoma.~   "
46664|NCT02446223|"~     Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic~     Keratosis of the Chest w/Ingenol Mebutate 0.015%~   "
46665|NCT02446210|"~     The long‐term goal is to acquire scientific knowledge that can be used to develop~     mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor~     function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed~     project will examine cortical, corticospinal, and spinal contribution to bilateral hand and~     arm muscle activity during bilateral movements and spinal contributions to lower limb muscle~     activity. By comparing changes in different sites within the Central Nervous System (CNS),~     the investigators may also identify key mechanisms that might be differentially affected by~     the injury, plasticity, and training.~   "
46666|NCT02446197|"~     Early initiation of therapy post stroke has been associated with improved long-term~     outcomes, and functional activity dose during the first week of inpatient rehabilitation~     predicts both gait velocity at discharge and length of time to independent walking. The~     primary study objective is to pilot the feasibility of integrating a patient-directed~     activity program into inpatient rehabilitation following stroke. The second study objective~     is to identify if participation in the patient-directed activity program improves functional~     ability and health related quality of life.~   "
46667|NCT02446184|"~     This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal~     cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and~     to compare to the investigators clinical experience with fetal vesicoamniotic shunting.~   "
46668|NCT02446171|"~     This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover,~     single-center, single-dose bioavailability study with alternate methods of administration of~     crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to~     whole naloxegol tablets, 25 mg, in healthy subjects.~      The main objective of this study is to determine the bioavailability of each of three~     alternative methods of naloxegol administration compared to whole naloxegol tablets given~     orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol~   "
46669|NCT02446158|"~     Chlorhexidine is used in central line dressing changes and is effective in reducing line~     infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal~     dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or~     exit site infection.~   "
46670|NCT02446145|"~     Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall~     survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly~     patients with AML is dismal and the majority of patients die within the first year after~     diagnosis. This is also because treatment options for elderly patients with AML~     significantly differ from patients of younger age. In fact, comorbid conditions are common~     among the elderly such as heart disease, renal insufficiency and vascular disease thus~     influencing the ability to withstand intensive therapy. Elderly patients are also more~     likely than younger patients to develop severe, life threatening infections during the~     course of treatment. In addition to infectious complications, hemorrhages due to severe~     thrombocytopenia are responsible for morbidity and mortality in a considerable amount of~     patients. Compared with younger AML patients, elderly individuals with AML display a higher~     incidence of poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and~     greater expression of proteins involved in intrinsic resistance to chemotherapeutic agents.~     As a result conventional anthracycline based chemotherapy is only infrequently used in~     patients above the age of 65 years. Based on a recent randomized trial (Kantarjian et al.~     2012) low-intensity epigenetic therapy with decitabine (DAC) has become the first-line~     standard of care in most European countries including Germany. Nevertheless, even with this~     treatment the 1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is~     a main side effect of this therapy and can prevent adequate continuation of treatment being~     crucially for treatment success. Supportive care with platelet transfusions is effective~     primarily only over short periods and often requires hospitalization and therefore lowers~     the quality of life of these patients in their palliative situation. Therefore, patients~     could benefit from an approach aiming at an increase of platelet counts through combined use~     of DAC with an oral thrombopoietin receptor agonist like eltrombopag (EPAG). This could~     allow for a better adherence to DAC therapy by preventing dose delays due to prolonged~     thrombocytopenia. Additionally, the potential antileukemic effect of EPAG could also be~     beneficial for these AML patients.~   "
46671|NCT02446132|"~     This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, which~     also allows participants from the Phase 2 Study 12-AVR-131 to be included.~   "
46704|NCT02445703|"~     The purpose of this study is to compare the immunogenicity and safety of three different~     immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A~     and B vaccine (HABV) in healthy Chinese infants.~   "
46705|NCT02445690|"~     One hundred and fifty patients with Crohn's disease involving the terminal ileum or the~     colon, in clinical remission, with or without endoscopic activity will be included. Thrombin~     generation will be measured and correlated with the simplified endoscopic activity score.~     The patients will be evaluated for development of deep vein thrombosis after one-year of~     follow-up.~   "
46672|NCT02446119|"~     Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence~     of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the~     integration of the propulsive forces of proximal fundic tone and distal antral contractions~     with the functional resistance provided by the pyloric sphincter. Pylorospasm has been~     reported in some patients with gastroparesis. This study protocol will assess pyloric~     sphincter pressure and geometry in patients with gastroparesis and control subjects without~     symptoms of gastroparesis. The commercially available FDA approved endoscopic functional~     luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure,~     length, and distensibility of gastrointestinal sphincter muscles along the balloon distance.~     It is used to measure the pressure characteristics of the lower esophageal sphincter during~     bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen~     fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy,~     which is routinely performed under sedation, patients with gastroparesis and controls~     without gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP.~     After passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced~     alongside the endoscope and advanced through the pyloric sphincter as visualized~     endoscopically. The investigators will measure the pressure and contour of the pyloric~     sphincter using three successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml,~     40 ml). The investigators will compare the results between the gastroparesis patients and~     the control patients without gastroparesis. Through this study, the investigators will~     better understand the abnormalities of the pyloric sphincter in patients with gastroparesis.~   "
46673|NCT02446106|"~     The objective of this study is to compare energy intake following consumption 0.5% MSG~     versus a control with no added MSG and matched for sodium in healthy non-smoking~     premenopausal female adults.~   "
46674|NCT02446093|"~     The study will investigate if the addition of GMCI to neoadjuvant mFOLFIRINOX +~     chemoradiation is safe and improves the clinical outcome of borderline resectable and~     unresectable locally advanced pancreatic adenocarcinoma, as measured by resection rate,~     progression-free survival and overall survival.~   "
46675|NCT02446080|"~     Constipation is defined as a disorder characterized by persistent difficulty to evacuate or~     a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors~     contribute to the onset of constipation, such as changes in dietary intake and fluid intake,~     decrease in consumption of products containing fiber, intake of drugs or laxatives,~     decreased intestinal motility and physical inactivity. The objective was to evaluate the~     effect of consumption of dairy products with probiotics on constipation. Randomized~     double-blind clinical trial in the city of Bom Retiro do Sul / RS, Brazil. They were~     recruited 60 female patients aged 20-50 years after application of the Rome III criteria~     (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology~     Organisation, 2010) were diagnosed with constipation. Patients were randomized into two~     groups, where one group will receive the milk drink with probiotics and the other group will~     receive a probiotic milk drink without (control group). The milk beverage consumption period~     shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast~     or morning snack.~   "
46676|NCT02446067|"~     The present study measures the cerebral hemodynamic indices of alcohol dependent patients~     and observe the relative changes in these parameters with rTMS application.~   "
46677|NCT02446054|"~     Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet~     control~   "
46678|NCT02446041|"~     The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness~     of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months~     after initiation of therapy between COPD patients who are adherent to the index medication~     and those who are non-adherent.~   "
46679|NCT02446028|"~     The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to~     Humalog®Mix 75/25 in patients with type 2 diabetes.~   "
46680|NCT02446015|"~     The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant~     Eye Drops using total ocular surface staining scores in subjects with dry eye administering~     it either as a scheduled regimen or as-needed after 28 days of treatment. This study will be~     conducted in the US and in Australia.~   "
46681|NCT02446002|"~     A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple~     doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the~     single dose pharmacokinetics of the oral lofexidine formulation.~   "
46682|NCT02445989|"~     The investigators propose to explore the hypothesis—supported by limited data—that a~     contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing,~     will enhance women's genital and reproductive health. The investigators propose that this~     CVR will increase the bacteria that help the vaginal environment protect against infection~     by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the~     quantity of HIV that is shed in the female genital tract.~   "
46683|NCT02445976|"~     The goal of this clinical study is to determine the safety and efficacy of VT-464, a~     lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with~     castration-resistant prostate cancer (CRPC) who have been previously treated with~     enzalutamide or abiraterone.~   "
46684|NCT02445963|"~     This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a~     InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a~     InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).~   "
46685|NCT02445950|"~     The purpose of this study is to examine whether the technology (web-based coaching,~     profiling and suggestion tool) brings added value to the traditional phone coaching in~     occupational health context. The interventions are phone counseling interventions. The other~     intervention exploits additionally a specific web-based coaching, profiling and suggestion~     tool.~   "
46729|NCT02445378|"~     This randomized clinical trial studies aromatherapy and essential oils in improving insomnia~     and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and~     essential oils may help improve insomnia and other complications caused by chemotherapy.~   "
46757|NCT02445014|"~     The goal of this research is to test the feasibility and tolerability of the modified,~     larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy~     subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux~     disease (GERD). This information will be used to assess optimal imaging technique, imaging~     quality, and subject tolerability.~   "
46758|NCT02445001|"~     Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye~     can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into~     a person's arm, the individual RBCs can be seen as they flow through the retinal blood~     vessels.~   "
46686|NCT02445937|"~     This is a comparative, effectiveness trial with the overarching goal of this research~     project to ensure patient-centered decisions about the use of intensive treatments for~     patients with advanced critical illness. In a prior project, the investigators developed the~     PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach),~     a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs,~     including: 1) changing care defaults to ensure clinician-family meetings within 48 hours~     of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and~     emotional support of surrogates before and during clinician-family meetings, 3) increased~     use of palliative care services for patients with a poor prognosis; and 4) structured~     communication at care transitions about patient's health care preferences and goals. The~     investigators propose to begin deployment of the PARTNERII program in the spring of 2015~     enrolling 690 patients and 690 surrogate decision makers in 5 ICUs using a stepped wedge~     design. The investigators expect to achieve the following project goals:~        1. To increase the patient-centeredness of end-of-life decisions, and to increase the~          quality of clinician-family communication.~        2. To decrease the psychological burden on family members acting as surrogates.~        3. Lower costs: To reduce total health care costs by increasing the use of palliative care~          and hospice services and decreasing unwanted readmissions near the end of life.~   "
46687|NCT02445924|"~     This study will be carried out on 40 subjects at Chest department Tanta university hospital~      The subjects will be classified into three groups:~        -  Group I: will include ten non smoker volunteers (control group I).~        -  GroupII: will include ten smoker volunteers (control groupII).~        -  Group III: will include twenty NSCLC patients confirmed by pathological examination of~          bronchoalveolar examination (BAL), brush and/or biopsy.~   "
46688|NCT02445911|"~     This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days.~   "
46689|NCT02445898|"~     The study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the~     effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV)~     to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and~     autonomic responses after THA.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will be less~     orthostatic intolerant, experience less orthostatic hypotension and have an improved~     autonomic response compared to the placebo-group, early after THA.~   "
46690|NCT02445885|"~     Although recommended therapy for patients with ST-segment elevation myocardial infarction is~     primary PCI, it remains unestablished whether patients with a symptom duration of more 12~     hours benefit from acute revascularisation.~      This study aims to investigate whether acute intervention is superior to subacute~     intervention in these patients.~   "
46691|NCT02445872|"~     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of~     chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed~     to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients~     receiving 3-day cisplatin-based chemotherapy.~   "
46692|NCT02445859|"~     We propose to randomise patients due to undergo colorectal surgery to standard antibiotic~     prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound~     infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime,~     repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by~     a continuous infusion of cefuroxime until the end of surgery. The intervention regimen~     dosing will be calculated using a patient's renal function and body weight. The intervention~     regimen will target a free serum drug concentration of 64mg/L. This serum level is 4x the~     MIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarised~     below. The primary objective of the study is to reduce by 50% the rate of surgical wound~     infections after colorectal surgery.~   "
46693|NCT02445846|"~     The purpose of this study is to provide evidence on the performance and operational~     characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in~     Zambia for their introduction into antenatal care and other settings.~   "
46694|NCT02445833|"~     Efficacy of an Internet-based self-guided intervention for promoting healthy habits and~     weight loss in hypertensive people with overweight and obesity: A Randomized Controlled~     Trial~   "
46695|NCT02445820|"~     This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES)~     130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid~     therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery~     patients.~   "
46696|NCT02445807|"~     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical~     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.~   "
46697|NCT02445794|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     RT001 in patients with Friedreich's ataxia.~   "
46698|NCT02445781|"~     Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To~     date no studies appear to have investigated the effects of differing levels of hypoglycemia~     on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The~     specific aim of our study will be to determine the effects of differing levels of~     hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.~   "
46699|NCT02445768|"~     The purpose now is to:~        1. identify brain connections related to proprioception to have a better understanding of~          differences between people with stroke and healthy persons~        2. evaluate how these brain connections will change in people with stroke when they are~          engaged in a 6-week neurocognitive therapeutic program.~   "
46700|NCT02445755|"~     The purpose of this study is to test the performance of a new transcutaneous (measured~     through skin) bilirubin device (BiliCare™) to measure bilirubin levels. The investigators~     plan to evaluate the clinical performance of this device as a point of care test. If the~     investigators can validate the BiliCare™ with bilirubin from your baby's blood they could~     verify a non-invasive alternative for measuring bilirubin.~   "
46706|NCT02445677|"~     Introduction: Chronic pain affects more than half of elderly individuals. Past studies have~     shown that pain can interfere with motor learning and rehabilitation. It was suggested that~     relieving pain before physical therapy sessions might be an interesting strategy to~     potentiate the rehabilitation of older patients suffering from pain.~      Objective: This study aims to determine if the analgesic effect induced by TENS can be used~     to maximize the rehabilitation of elderly patients suffering from chronic pain. More~     specifically, the objectives are to: 1) compare functional outcomes of patients from the Day~     Hospital receiving rehabilitation with either active TENS treatments or simulated TENS~     treatments, and 2) determine if there is an association between the analgesic effect of TENS~     and the clinical evolution of patients following their rehabilitation.~      Methods: In this RCT, patients will be assigned randomly to either the: 1) experimental~     group receiving active TENS treatments or 2) the control group receiving simulated TENS~     treatments. Thirty-six patients will be recruited according to the following criteria: 1)~     will receive physiotherapy rehabilitation at the Day Hospital of the CSSS-IUGS, 2) be at~     least 65 years of age, 3) suffering from chronic pain (pain lasting for more than 6 months),~     4) presenting pain during the rehabilitation at the Day hospital. For security reasons,~     patients with a cardiac simulator will be excluded from the present study (TENS~     contraindications). Patients with cognitive alterations (score of < 24/30 at the Folstein~     test) will also be excluded. Sociodemographic information will be retrieved from medical~     records by the research assistant at baseline (T1). Moreover, various questionnaires will be~     administered at T1, after half of the rehabilitation period (i.e. 4 to 6 weeks) (T2), and~     after the 8- to 12- week rehabilitation period (T3) to measure the qualitative aspects of~     pain, mood, and physical function. Functional outcomes will as well be collected directly~     from the medical record at each assessment times (T1, T2 and T3).The measures include~     exercise tolerance, balance, mobility and balance, and functional ability.~      Anticipated results: We believe that: 1) use of active TENS during the rehabilitation~     sessions will potentiate rehabilitation of patients suffering from chronic pain at the~     CSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect induced~     by TENS and the clinical evolution of patients.~   "
46707|NCT02445664|"~     Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized~     problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and~     involvement. In this study the investigators aimed to determine the effect of an educational~     video displayed on a tablet-device. The investigators hypothesized that an educational video~     would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.~   "
46708|NCT02445651|"~     Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more~     than a million Americans. It's most prominent pathology is the degeneration of dopaminergic~     neurons in the brain. It is believed that oxidative stress and inflammation play an~     important role in the pathophysiology of Parkinson's disease as well.~      The object of this study is to evaluate whether nutritional supplementation with compounds~     that have been shown to have either anti- inflammatory, or antioxidant effects, might~     support brain function in patients with Parkinson's disease, particularly in regards to the~     dopamine system. Enrolled patients will be randomly assigned to receive oral and intravenous~     n-acetyl cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan)~     single photon emission computed tomography (SPECT) to measure dopamine function, magnetic~     resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and~     neurological measures to assess clinical symptoms, in patients with PD. Subjects will~     receive a DaTSCAN and MRS initially and after completing the supplement or NAC regimen.~   "
46709|NCT02445638|"~     The objective of this randomized, single blinded cross-over study is to investigate effects~     of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL)~     composition and function in a population of overweight and obese postmenopausal women.~   "
46710|NCT02445625|"~     This study aims to demonstrate that improvements in identification of social clues (and~     improvement of overall social behaviour) in subjects with ASD can be achieved using social~     games together with a BCI setup.~      The primary goal is to ensure increased rate of responses to joint attention cues.~      Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial~     eligibility screening (within 1 week after admission), (2) pre-intervention (first week of~     study, baseline outcome measures and additional evaluations), (3) intervention process (16~     weeks), (4) post-intervention (outcome measures and additional evaluations), and (5)~     follow-up (outcome measures at 6 months).~   "
46711|NCT02445612|"~     This is the long term follow-up of a safety and tolerability trial to evaluate the effect of~     subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells~     in patients with Stargardt's Macular Dystrophy (SMD).~   "
46712|NCT02445599|"~     The purpose of the study is to examine if the hyposthesis of the preventive analgestic~     characteristic of diclofenac given preoperatively has any effect on postoperative thoracic~     wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption~     and the postoperative lung function test values.~   "
46713|NCT02445586|"~     Study of Pertuzumab (In Combination with Trastuzumab and Docetaxel) in Indian Patients with~     Breast Cancer~   "
46714|NCT02445573|"~     The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA)~     for women with pure stress urinary incontinence (SUI).~   "
46715|NCT02445560|"~     The purpose of the proposed study is to determine the effects of consuming a high protein~     diet on fecal microbial communities, gastrointestinal function and symptoms, and general~     wellness in older adults.~   "
46716|NCT02445547|"~     Stem cell transplantation has emerged as a relatively popular treatment that can help to~     regulate immunity, repair injury, and control inflammation. Several studies have used~     autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its~     associated complications, and have achieved good efficacy. Thus far, the use of umbilical~     cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In~     this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We~     observed the disease control conditions, corticosteroid dosage changes, and~     treatment-related adverse reactions.~   "
46717|NCT02445534|"~     Although several studies have demonstrated beneficial effects of stem cell therapy in~     patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of~     response to therapy remain undefined. The aim of this registry is to pool long-term clinical~     data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy~     in an attempt to better define predictors of response to such treatment.~   "
46718|NCT02445521|"~     The objective of this study is to test four home phenylalanine monitoring prototype devices,~     selected out of a pool of candidates by the National PKU Alliance Scientific Committee.~   "
46754|NCT02445053|"~     To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF)~     who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N,~     S1255P, or G1349D).~   "
46755|NCT02445040|"~     The purpose of this study is to determine the safety and effectiveness of the Babylog VN500~     in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low~     birth weight (VLBW) neonates requiring invasive respiratory support in the treatment of~     respiratory distress.~   "
46719|NCT02445508|"~     Accumulating evidence suggests that bile acids in our intestines may constitute essential~     components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile~     acids can lead to changes in gut hormone secretion and consequently affect glucose~     homeostasis.~      The current study is a human interventional randomized controlled cross-over study including~     four study days for each participant. As a tool to sequester bile acids we will use~     sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult~     patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve~     glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous~     infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The~     aim is to examine how (and if) bile acid sequestration can influence postprandial~     glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2~     diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in gut hormone secretion. The current study will help to clarify~     this hypothesis and improve our general understanding of the association between bile acid~     circulation and signalling, gut hormone secretion and glucose metabolism.~   "
46720|NCT02445495|"~     The purpose of this study is to determine if toenail onychomycosis can be reduced by means~     of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.~   "
46721|NCT02445482|"~     In recent years, the advance in high-throughput techniques, such as microarrays and next gen~     sequencing (NGS) technologies, have allowed a more precise classification of the breast~     cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date,~     conventional methods to select patients for clinical trials with anti-targeted agents~     according to molecular criteria are generally limited to the analysis of a few biomarkers.~     Recent studies have shown how this strategy is inappropriate in case of infrequent molecular~     alterations and that the ideal strategy would consist in simultaneous examination of large~     numbers of actionable genomic alterations.~      This is the first genomic screening platform ever attempted in Spain. By this molecular~     platform SOLTI aims to increase the likelihood of a patient being included in a trial~     designed specifically for her molecular tumor type. Thus, the primary objective of this~     pilot study is to determine the Platform's effectiveness to include patients in clinical~     trials with targeted agents based on the tumor molecular profiling.~   "
46722|NCT02445469|"~     Parkinsonian syndrome is clinically characterized by the presence of resting tremor,~     rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's~     disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple~     system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular~     physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed~     at finding markers to early make the distinction between the different types of~     parkinsonism, in order to identify patients who could benefit from dopaminergic agonist~     therapy.~      Excessive iron deposition in the subcortical and brainstem nuclei has been described in~     numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels~     are more frequent in area that are rich in dopaminergic neurons and have been implicated in~     the development of movement disorders, the distribution of areas with increased iron~     deposition however varying according to parkinsonism types. Iron deposition quantification~     could thus potentially help in differentiating parkinsonism types and could improve therapy~     guidance. Quantitative susceptibility mapping (QSM) locally estimates the magnetic~     susceptibility of brain tissues based on gradient-echo signal phase. The local~     susceptibility being sensitive to the presence of paramagnetic susbtances, QSM allows the~     non-invasive evaluation of iron distribution and quantification in the brain with high image~     quality (Liu et al., 2013). However, since iron deposition followed an exponential curve~     during normal aging in most of the basal ganglia the potential of QSM to distinguish between~     healthy and parkinsonian subjects in elderly remains unclear.~      The aim of this study was thus to determine susceptibility values in the basal ganglia of~     elderly patients with parkinsonian syndromes, to compare these values to healthy~     aged-matched controls and between parkinsonian syndrome types. Secondly, investigators aimed~     to evaluate microstructural changes in the basal ganglia using diffusion tensor imaging~     (DTI) in the same population and to determine whether susceptibility and DTI parameter~     changes are correlated. Finally investigators sought to assess the relation between~     susceptibility/DTI parameter values in the basal ganglia and behavioral measures of motor~     and cognitive abilities.~   "
46723|NCT02445456|"~     This study will assess whether the Sienna+/Sentimag system, which involves a magnetic~     tracer, is effective in identifying the sentinel lymph node in rectal cancer and whether it~     is then feasible to remove this lymph node during surgery to locally excise early rectal~     cancer.~   "
46724|NCT02445443|"~     The purpose of the current investigation is to assess the safety and efficacy of a new~     hinged revision knee device. This device is designed to provide efficient, reproducible~     reconstructions with optimal limb and implant alignment, durable implant fixation, and~     functional outcomes that increasingly approach those of primary Total Knee Arthroplasty~     (TKA).~   "
46725|NCT02445430|"~     The goal of this study is to identify genetic alterations resulting in the development of~     arteriovenous malformation (AVM) in the central nervous system.~   "
46726|NCT02445417|"~     The purpose of this study is early identification of asphyxiated newborns through eeg~     starting in the delivery room.~   "
46727|NCT02445404|"~     It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently used~     but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to~     consider the clinical trial at NCCN guideline.But why the CHOP regimen is widely used~     because physicians are accustomed to use. Fractionated ICED therapy is a therapy by~     adjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into three~     days. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvage~     therapy of patients with relapsed or refractory lymphoma for a long time, it has been~     recommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added to~     dexamethasone therapy in order to improve the effectiveness as a primary therapy.The~     recurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stem~     cell transplantation, showed a more than 40% progression-free survival.Thus treatment of~     Fractionated ICED targeting previously untreated patients, and if a combination of high-dose~     dexamethasone to expect to be able to induce a progression-free survival of 60% or more.~   "
46728|NCT02445391|"~     This randomized phase III trial studies how well cisplatin or carboplatin (platinum based~     chemotherapy) works compared to capecitabine in treating patients with remaining (residual)~     basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant).~     Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     cisplatin or carboplatin is more effective than capecitabine in treating patients with~     residual triple negative basal-like breast cancer.~   "
46730|NCT02445365|"~     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time~     of diagnosis it is not possible to predict the course of the disease, which can range from a~     few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and~     stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic~     tools.~      This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic~     conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The~     investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage~     has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief~     and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC~     is likely to involve suppressed inflammation and cell death.~      Our study is a randomized clinical controlled study including 38 patients. Patients will~     receive RIC or sham for 10 consecutive days.~      The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy~     findings, and various markers in the blood, faeces and the intestinal wall.~   "
46731|NCT02445352|"~     The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with~     primary hypercholesterolemia.~   "
46732|NCT02445339|"~     Our primary aim is to assess the feasibility of initiating treatment in the ED with~     extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and~     continuing care in cooperation with clinic providers as well as how best to assess outcomes.~     Secondarily, the investigators will explore its effect on various health outcomes~     (healthcare utilization and engagement, expenditures, drinking and consequences, quality of~     life) as well as the association of patient-level characteristics (e.g. sex, race, baseline~     drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness.~     Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase~     1) is essential before planning a large-scale effectiveness trial (phase 2).~   "
46733|NCT02445326|"~     The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained~     release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of chronic allergic conjunctivitis.~   "
46734|NCT02445313|"~     The investigators would like to know if different imaging devices can improve the quality of~     images and visualization of imaged tissues. Also, the investigators would like to find out~     whether these changes are useful in the diagnosis and treatment of eye diseases. Using~     images of previous participants will allow us to demonstrate the advancement of different~     technologies, as well be used to allow comparisons between current technologies.~   "
46735|NCT02445300|"~     The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant~     improvement in the efficacy of wound care and wound complications compared with traditional~     Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).~   "
46736|NCT02445287|"~     The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM~     Cone Beam Computed Tomography (CBCT) scanner (investigational device) against the~     commercially available 2D and 3D predicate devices. The results of this study will be~     included in a Traditional 510(k) FDA Submission to obtain clearance to market the new~     CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in~     accordance with the FDA Guidance titled Guidance for the Submission of 510(k)'s for Solid~     State X-ray Imaging Devices, issued on August 6, 1999.~   "
46737|NCT02445274|"~     In this study, the investigators introduce a new capsule-reserved cataract surgical~     procedure in which anterior lens capsule is reserved and attached onto posterior lens~     capsule in the purpose of preventing posterior capsule opacification (PCO). A prospective~     randomized controlled study is reported to compare the new capsule-reserved surgical~     procedure with conventional one on the effectiveness to prevent posterior capsule~     opacification in age-related cataract patients.~   "
46738|NCT02445261|"~     Women were instructed not to use the mobile phones for 24 hours before carrying out the~     initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace~     recording was done followed by umbilical artery Doppler ultrasound using high resolution~     ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic~     a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the~     mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The~     umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference~     with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal~     heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with~     respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of~     fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance~     of spontaneous decelerations.~   "
46739|NCT02445248|"~     This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in~     adult patients with relapsed or refractory DLBCL.~   "
46740|NCT02445235|"~     This observational study is designed to evaluate the reported outcomes for patients~     receiving topical therapy for the treatment of pain, fungal infections or skin scars. The~     patients will complete the Patient Reported Outcome (PRO) survey monthly and provide~     valuable data on the patients perception of their health status and well being while~     receiving therapy.~   "
46741|NCT02445222|"~     Per Health Authorities guidelines for gene therapy medicinal products that utilize~     integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of~     treated patients is required. The purpose of this study is to monitor all patients exposed~     to CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)~     infusion to assess the risk of delayed adverse events (AEs), monitor for replication~     competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.~   "
46742|NCT02445209|"~     The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX~     and mDCF regimens in the first-line treatment of patients with advanced HER2-negative~     gastric and gastroesophageal junction (GEJ) adenocarcinoma~   "
46756|NCT02445027|"~     The goal of this study is to test the feasibility and acceptability of tethered capsule~     Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening~     in the primary care practice environment.~   "
46743|NCT02445196|"~     PTSD Coach is a mobile application (app) that aims to teach individuals self-management~     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major public~     health concern. Although effective treatments exist, affected individuals face many barriers~     to receiving traditional care. As smartphones are now carried by more than half of the U.S.~     population, they have the potential to overcome many of these barriers by delivering~     self-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitive~     behavioral strategies there is still a need to test the effectiveness of the app in managing~     PTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy,~     feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample of~     trauma survivors with PTSD symptoms. After completing an eligibility phone screen or online~     screen, individuals who score a 35 or above on the PTSD Checklist for DSM-5 (PCL-5) and~     consent will complete a baseline assessment and then be randomized to the PTSD Coach app~     condition or a waitlist control group. Additionally, those assigned to the PTSD Coach~     intervention will be instructed to download a research version of the app, called PTSD~     Explorer, that enables passive and objective monitoring of app use. Each individual will be~     reassessed at post-intervention (3 months) and follow-up (3 months later, or 6 months after~     completing baseline). The investigators predict that those using the PTSD Coach app will~     demonstrate a significant and sustained reduction in PTSD symptoms and increase in patient~     coping self-efficacy compared to the waitlist control group. The investigators will explore~     if there is a relationship between levels of engagement and PTSD symptom change.~   "
46744|NCT02445183|"~     The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an~     ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been~     reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be~     retrospectively verified with additional medical data collection pertaining to lung cancer.~     Additional 'control' subjects will also be identified and verified as a 'no lung cancer~     controls'. Data previously collected through the COPDGene® Study, including QCT results and~     clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as~     variables for analysis.~   "
46745|NCT02445170|"~     The present study assesses the health-related quality of life of diabetic transmetatarstal~     and below-knee prosthetic user. The study design is cross-sectional with a retrospective~     review of patient hospital records and an assessment with patient-reported outcome measure.~   "
46746|NCT02445157|"~     This study is investigating the reliability of the 4 metre gait speed test (4MGS) in~     patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).~   "
46747|NCT02445144|"~     Patients with sickle cell anemia (SCA) are at an increased risk for damage to brain tissue~     due to their disease. The investigators are interested in how blood flow and cerebral~     inflammation are different in SCA patients and how that affects brain tissue- the~     investigators will use a relatively new set of dynamic MRI techniques to evaluate these~     parameters. The investigators will image participants with both SCA and matched controls~     with non-invasive MRI.~   "
46748|NCT02445131|"~     The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the~     efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an~     induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and~     GA101-maintenance in CLL patients~   "
46749|NCT02445118|"~     This is a 16 week pilot study to assess short term outcomes of an injectable allograft~     adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30~     patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume~     retention and local skin changes will be observed and documented prior to and following~     injection at week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done~     via photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo~     magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a~     control and will receive no injection. Analysis includes volume retention, tissue analysis,~     local skin changes and adverse events, if any.~   "
46750|NCT02445105|"~     This multisite study will compare the effectiveness of universal screening by 3 community~     service systems using Autism Navigator, a highly interactive web platform that includes an~     automated screening tool, information about autism for families, and a professional~     development course on the early signs of autism and effective evidence-based practice with~     extensive video footage to rapidly build the capacity for early detection. The investigators~     will also conduct a multisite pragmatic randomized clinical trial to test the effectiveness~     of an evidence-based Family Engagement Intervention compared to Autism Navigator Enhanced~     Practice implemented by the 3 community service systems with children who have a positive~     autism screen to increase the number of children who are screened, referred for evaluation,~     receive a diagnosis, and receive community-based EI between 18-27 months of age. This study~     will impact family engagement in community screening and diagnosis by demonstrating the~     effectiveness of brief manualized engagement interventions. Findings will advance science by~     providing researchers with a method for recruiting a community sample, allowing for research~     at younger ages, which could accelerate science.~   "
46751|NCT02445092|"~     The investigators hypothesize that washing the insemination catheter prior to performing the~     IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when~     compared to controls (without pre-washing the catheter).~      Catheter washing is performed routinely before embryo transfer, however it is not done for~     IUI catheters. Therefore no data is available on applying the technique to IUI catheters~     prior to insemination.~   "
46752|NCT02445079|"~     Longitudinal cohort study of older-aged people living with HIV infection in southwestern~     Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring~     the epidemiology of cardiovascular and pulmonary disease in this study setting, and~     particularly the contribution of HIV infection to it.~   "
46753|NCT02445066|"~     This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with~     initial 25(OH)D concentrations of 12-<18 ng/mL to explore the effect of increasing 25(OH)D~     concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial~     bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria,~     and muscle fibers as well as the expression of mitochondrial proteins and regulators of~     mitochondria biogenesis before and after supplementation. All participants will be given~     vitamin D3 (4,000 IU/d) for 4 months.~   "
46759|NCT02444988|"~     The administration of intravenous fluids is ubiquitous in the care of the critically ill.~     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte~     compositions including a range chloride concentrations. Recent studies have associated~     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and~     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased~     mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be~     a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from~     the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary~     endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment~     (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at~     discharge).~   "
46760|NCT02444975|"~     The purpose of this study is to determine whether increased water intake is effective in~     preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women~     suffering from UTI recurrences.~   "
46761|NCT02444962|"~     At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center~     (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with~     an episthesis. Retention can be achieved using adhesives, undercuts or bone implants.~     Implant based episthesis are now commonly used because of the good retention and episthesis~     stability. This results in a better patient quality of life.~      Today we use machined surface implants in the craniofacial region of different brands. Each~     system has its own instruments and application method. To enhance the clinical usability, we~     are searching for one system for all extra-oral implant regions.~      Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and~     radiation therapy, which can affect the bone healing process. In these cases, implants are~     known to have higher failure rates compared to the application in healthy cases. Therefore~     implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may~     have a positive effect on osseointegration, resulting in higher success rates in the~     compromised patient.~      The aim of this pilot study is to collect information about the functionality and safety of~     a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after~     ablative surgery in the nasal, orbital and auricular region for a potential future RCT.~   "
46762|NCT02444949|"~     Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of~     recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way~     of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil~     (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of~     angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease~     the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor~     (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the~     migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce~     vascular remodeling and normalization of the tumor vasculature, which will effectively aid~     the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with~     chemoradiotherapy will be a promising way of treatment for NPC. In this study, the~     first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with~     recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group~     (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a~     control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including~     progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse~     effects rate and quality of life. This research will provide more evidences of~     evidence-based medicine for the safety and tolerability of endostar and the clinical~     application of endostar in NPC treatment.~   "
46763|NCT02444936|"~     This study evaluates if the shingles vaccine works in those persons that receive it before~     they receive chemotherapy for solid organ tumors. Half of the participants will receive the~     ZOSTAVAX shingle vaccine and half of the participants will not received anything.~   "
46764|NCT02444923|"~     The most common causes for irregular cornea (IC) in hospital contact lens practice are~     Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to~     marked impairment of vision and cannot be effectively corrected by spectacles and soft~     contact lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable~     contact lenses (corneal lenses), which correct approximately 90% of the corneal~     irregularity.~      Compared with a normal cornea, the cornea in KC is irregular and this results in a~     compromise to the fit of rigid corneal lenses. Specifically, they bear on the cornea and~     this, together with the vulnerability of the cornea in KC, are implicated in corneal~     scarring, and disease progression as well as a significantly reduced vision related quality~     of life (QoL) in KC compared with corneal lens wearers who have no KC.~      In cases where the compromise fit of corneal lenses proves problematic, large diameter~     Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the~     smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over~     the cornea and bear on the sclera.~      The aim of this research is to investigate the performance of scleral lenses in KC~     participants who habitually wear corneal lenses.~      The research question: is there a measurable difference in the visual performance and visual~     quality of life in participants with Irregular cornea disorders like keratoconus and other~     related conditions, who habitually wear corneal lenses in comparison with scleral lenses.~   "
46779|NCT02444728|"~     Treating severe thrombocytopenia is a challenge in the management of systemic lupus~     erythematosus. Although rheumatologists have followed some rules in real practice,there is~     very few evidence to support the current treatment algorithm. The purpose of this study is~     to compare the complete remission rate and partial remission rate of cyclophosphamide and~     hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.~   "
46797|NCT02444494|"~     The objective of this non-interventional study is to evaluate clinical effectiveness and~     cost effectiveness of Dysport within the reimbursement scheme called drug programme funded~     by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is~     designed to collect data in patients scheduled to receive Dysport treatment in a drug~     programme, based on routine treatment of subject with ULS.~   "
46765|NCT02444910|"~     KDT501 is an orally administered product designed to help control impaired glucose and~     insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate~     agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein~     receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin~     sensitivity and glucose regulation as well as reduce proinflammatory signals. These~     properties combined with antihyperglycemic activity and modest, partial agonist effect of~     KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an~     atypical and pleiotropic mechanism of action for KDT501.~      Following providing informed consent, potential subjects will undergo screening procedures~     to ensure that they meet all inclusion and exclusion criteria. Following registration on~     study, subjects will undergo baseline pretreatment studies, including two abdominal fat~     biopsies, one taken after cold challenge, as well as determination of resting metabolic~     rate, a 4 hour lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment~     studies in registered subjects will be performed within 7 days prior to initiating therapy.~     On the first day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in~     the clinic, followed by serum pharmacokinetic (PK) samples being obtained every hour for 6~     hours after dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice~     daily. All doses will be taken with meals (breakfast and dinner). On Day 7, subjects will~     return to the clinic to undergo safety and laboratory assessments, including PK. On Days 14~     and 21, subjects will again return to the clinic to undergo safety and laboratory~     assessments. On Day 17 subjects will return to the clinic for PK studies, as noted below.~     Treatment in all subjects will end on Day 28. Rapid PK assessment of drug exposure, defined~     as AUC0-12h, will be performed following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h,~     8h, 10h, and 12h on both Days 7 and 17. On Days 11 and 21 (±1day), based on the KDT501 drug~     exposure level, the subject will be provided instructions on dose adjustments of KDT501. The~     maximum allowed KDT501 exposure ceiling for all subjects enrolled is AUC0-12h =~     22,500ng-hr/mL.~   "
46766|NCT02444897|"~     This study was designed to assess the effectiveness of epidural patient-controlled analgesia~     compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic~     gastrectomy. The investigators hypothesized that epidural PCA would be more effective in~     pain control than IV PCA even for laparoscopic gastrectomy.~   "
46767|NCT02444884|"~     RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to~     see how well it works in treating young patients with relapsed or refractory solid tumors~   "
46768|NCT02444871|"~     The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins~     (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic~     and aggregometric measurements of patients with severe sepsis.~   "
46769|NCT02444858|"~     Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem~     cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single~     blind, controlled prospective study.~   "
46770|NCT02444845|"~     The purpose of this study is to evaluate the prevalence of Chronic Kidney Disease~     (CKD)-related anemia at an early stage through screening of high-risk patients in Pakistan~     at the level of physicians, cardiologists, and diabetologists. The information gathered may~     serve as a foundation in formulating national guidelines for better early diagnosis and~     management of patients with CKD.~   "
46771|NCT02444832|"~     Based on the anatomical features of the anterior Communicating artery complex, the~     investigators will analyze the outcome of the ACoA aneurysms treated by endovascular~     therapy.~      The most common site of intracranial aneurysms is the anterior communicating artery (AcomA).~     AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.~      Recent publications have addressed specifically the endovascular treatment of AcoA~     aneurysms. Furthermore, detailed anatomic characteristics and the effects of the multiple~     variations of the anterior communicating artery complex have scarcely been reported.~      The hemodynamic factors play a fundamental role in the adequate treatment of aneurismal~     coiling.~      The objective of our registry is to analyze the impact of morphological configuration of the~     anterior communicating artery complex and the results of coil embolization in AcoA aneurysms~   "
46772|NCT02444819|"~     A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of~     HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR~     mutation~   "
46773|NCT02444806|"~     The study aims to compare 2 different strategies used to setup non-invasive ventilation in~     patients with OCPD-OSA overlap.~   "
46774|NCT02444793|"~     This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate~     the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D)~     investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with~     advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761~     is estimated (dose finding), one or more expansion cohorts of patients with selected~     advanced solid tumors (dose-expansion ) will be enrolled to further characterize the~     combination in term of safety profile, anti tumor activity, pharmacokinetics,~     pharmacodynamics and biomarkers modulation.~   "
46775|NCT02444780|"~     Earlier studies showed that a low glutamine level at acute admission on the ICU is~     associated with a poor outcome [3,4]. Recently, we found that a low plasma glutamine is~     correlated with severity of illness and presence of an infection after non-elective ICU~     admission [5, submitted].~   "
46776|NCT02444767|"~     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to~     the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle~     glaucoma or ocular hypertension.~      This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in~     healthy (non-glaucoma) subjects.~   "
46777|NCT02444754|"~     This pilot research trial studies minority patients receiving care at the Comprehensive~     Cancer Center of Wake Forest University (CCCWFU) to see what their attitudes are regarding~     the healthcare they receive and how much they know about clinical trials. Clinical trials~     are an important way to test healthcare treatments and need diverse participants to be most~     effective. Studying what minority patients think about healthcare and clinical trials may~     help researchers learn more about why minorities are less likely to enroll in clinical~     trials and create programs to help increase their enrollment.~   "
46778|NCT02444741|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     the combination of Keytruda (pembrolizumab, also called MK-3475) and radiation therapy~     (either conventional or stereotactic body radiation therapy [SBRT]). The safety of this~     combination will also be studied.~      The goal of Phase 2 of this study is to learn if this combination therapy can help to~     control metastatic NSCLC.~   "
46817|NCT02444234|"~     The proposed study is designed to characterize the pharmacokinetics of intravenous and oral~     tedizolid in patients with Cystic Fibrosis.~   "
46780|NCT02444715|"~     Stroke is one of the most frequent and life-threatening diseases in Europe. About four~     stroke events occur per day in Luxembourg alone, and about 30% of these patients are~     affected by recurrent stroke within the following five years. Thus, new methods of primary~     and secondary prevention are needed to better control lifestyle-related risk factors.~      The development and maintenance of a healthy lifestyle (smoking cessation, healthy~     nutrition, moderate physical exercises etc.) is a major objective concerning the primary and~     secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based~     lifestyle coaching system developed by researchers from the Public Research Centre (CRP)~     Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de~     Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior~     changes in order to minimize their individual risk factors. Patients can access CAPSYS by~     dialing a local-rate telephone number and answer to a set of previously known questions~     concerning their current nutrition, physical activity, blood pressure, smoking etc. In an~     interactive voice response approach, questions are issued by the system in natural language~     using text-to-speech, and the patient can provide the required values using the phone~     keypad. Based on the gathered values for each patient, the system automatically generates~     personalized verbal feedback at runtime and presents it to the patient during the phone~     dialog. Depending on the individual development of the patient's risk factors, the system~     feedback can contain advice for improvement, praise for healthy behavior and motivation to~     pursue a certain goal.~      The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month~     randomized controlled study with participants recruited at CHL's neurology department.~   "
46781|NCT02444702|"~     The long term goal of this project is dual fold. First, the investigators wish to derive,~     validate and then test the impact of a clinical prediction rule to determine which patients~     who suffer from CLBP with degenerative changes of the lumbar spine and referred pain to the~     legs are likely to require surgery and have successful outcomes in the long term. Second,~     the investigators would like to establish robust methodology and statistical analysis~     guidelines for creating clinical prediction rules in physical therapy research. This~     observational cohort project is a first step towards those goals. Here the investigators~     specifically aim to identify personal, behavioral, psychological, morphological, and~     physical factors that can predict the need for surgery as well as level of participation~     restriction in patients who suffer from CLBP with degenerative conditions of the lumbar~     spine and referred pain to the legs. The investigators will also explore which parameters~     can predict success after 1 month, 6 and 12 months in patients who underwent~     decompression/fusion surgery.~   "
46782|NCT02444689|"~     The purpose of this study is to evaluate the effectiveness of a technology-based behavioral~     Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean~     daytime ambulatory systolic BP), and heart size (LVM) in comparison to standard care.~   "
46783|NCT02444676|"~     Background: Heart failure (HF) is in many cases the final way for coronary heart diseases.~     In older than 65 years is the most important cause of hospitalization. Many studies have~     analyzed the causes of decompensation and the possible causes of hospital re-admission but~     most evidences come from the hospital setting. Nevertheless, It is known that many of these~     patients are usually attended in primary care setting, being treated by their General~     Practitioner and are not referred to the hospital.~      The determinants which condition whether stable HF patients will be hospitalized as a~     consequence of a decompensation remain still unclear.~      Objective: To develop and validate a predictive model based on clinical variables easy to~     measure at primary care to predict short-term hospitalization or mortality in a cohort of~     patients attended in primary care setting as a consequence of a HF decompensation.~      Methods: A cohort of patients with established HF attended in primary care setting (regular~     care or out of hours) as a consequence of an episode of HF decompensation will be follow up.~     To develop the predictive model we will select variables which previously have been found~     involved in the risk of hospitalization or mortality as a consequence of HF as well as other~     ones which could be relevant and have not been studied yet. Variables selected should be~     easily determined in primary care setting..~      The predictive model obtained in the derivation cohort from Spain will be validated in an~     external (several European countries) validation cohort.~      Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization~     or death and manage them according to an accurate prognostic rule (escala pronostica) made~     in primary care setting.[DISCUTIR]~   "
46784|NCT02444663|"~     X-rays are the most frequently used imaging test when evaluating the knee for joint~     replacement. They are non-invasive, safe and cost effective. They allow assessment of:~     progression of disease, appropriateness for joint replacement (in particular~     unicompartmental knee replacement (UKR)) as well as likely prognosis following replacement.~      Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray~     views. In addition in patients being considered for joint replacement valgus/varus stress~     X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament)~     and medial compartment respectively to assess the status of the cartilage. Stress X-rays~     require the clinician to attend X-ray, often during busy clinics, exposing them to~     additional radiation, and as such they are seldom performed.~      A patient and user friendly device for performing valgus and varus stress X-rays of the knee~     for diagnostic and pre-operative planning purposes in the setting of knee replacement~     surgery has been developed. This device has the potential to benefit patients as it will~     allow an accurate assessment of the pattern and severity of arthritis affecting their knee~     without the need for additional diagnostics such as MRI or arthroscopy. Furthermore for~     healthcare practitioners and providers this device will facilitate the smooth running of~     clinics and reduce the additional clinic appointments required to review MRI results.~     Ultimately this device will allow an informed discussion about treatment options, reduce the~     pre-operative uncertainty about suitability for UKR in those undergoing surgery and ensure~     that those patients who are suitable for UKR benefit from this procedure. This device will~     help ensure that patients receive the optimum treatment in a clinically and cost efficient~     manner.~      This study will validate valgus and varus stress X-rays performed using the investigators'~     device against the gold standard of clinician performed manual stress.~   "
46785|NCT02444650|"~     Optically-based data will be compared to tonometry to determine correlation of pulse wave~     velocity measurement.~   "
46786|NCT02444637|"~     Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is~     authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.~      In this trial, the investigators will be studying the effectiveness of Rivastigmine in~     subjects with AD and cerebrovascular disease.~   "
46787|NCT02444624|"~     The clinical study involves a French network of 20 neonatology centres created as part of~     the EPIFLORE project. Investigators propose including all premature babies with confirmed~     necrotizing enterocolitis (NEC) diagnosis (Bell stage II or III) paired with a control group~     of healthy premature babies, over a 2-year period. The clinical data will be entered at~     inclusion until departure from the department, and the ASQ (Ages and Stages Questionnaires)~     will be collected after 24 months. Samples from NEC cases and from the control group will be~     submitted for microbiological testing by culture and pyrosequencing. This will enable the~     main aerobic micro-organisms in the dominant and subdominant intestinal microbiota to be~     isolated. This case-control study will be used to compile a collection of clinical and~     microbiological data, in order to confirm the role of bacteria in the pathophysiology of~     NEC, and to confirm the involvement of bacteria from the Clostridium genus in particular.~   "
46788|NCT02444611|"~     Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood~     disease-specific immunisation is irrefutably linked to the decline in deaths from these~     targeted infections over the last century. However, neonatal immunisation is limited, in~     part, by the impaired adaptive immune function in this age group.~      There is now an expanding body of evidence for heterologous ('non-specific') effects of~     various vaccines used in childhood. This refers to the immunomodulatory capabilities of~     vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The~     underlying immunological mechanisms responsible for these effects are incompletely~     understood, but evidence is mounting that the innate immune system is central to these~     observed effects.~      This study is a randomised controlled trial designed to determine the influence of two~     commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth,~     on the neonatal immune responses to non-specific antigens.~      The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne,~     Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups,~     receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1~     week post randomisation) A blood sample will be taken at 1-week post randomisation for in~     vitro immunological analyses.~      This study will improve current understanding of the influence of vaccines on neonatal~     immunity and will help develop strategies exploiting beneficial heterologous~     ('non-specific') effects to improve protection against infection in the very young.~   "
46789|NCT02444598|"~     There is a treatment method called negative-pressure wound therapy (NPWT) that is well~     established and used for the treatment of wounds. The method involves the application of a~     wound dressing through which a negative pressure is applied. Due to a plastic film~     overlaying the wound the risk of wound contamination is reduced. NPWT is considered to~     promote wound healing and prevent infection and has previously been used in the treatment of~     acute war associated wounds with satisfactory results. The aim of this study is to compare~     NPWT with conventional wound dressings in the treatment of war-associated extremity wounds~     and evaluate which method is more effective.~   "
46790|NCT02444585|"~     The overall objective of the proposed study is to quantify bone loss around non-cemented~     total hip replacement femoral and acetabular components using DEXA analysis in patients~     receiving Prolia (denosumab) in the first year of follow up after total hip joint~     replacement surgery, and to compare this to bone loss in control hip replacement patients~     receiving a placebo.~      The primary outcome variable will be the difference in loss of bone mineral density between~     the experimental group taking denosumab and the placebo control group, calculated as a~     percentage, in Gruen Zone 7, the proximal medial calcar region of the femur, over a~     follow-up period of 12 post-operative months.~      The secondary objectives will be to assess the following variables:~        -  Bone turnover differences between the experimental group taking denosumab and the~          placebo control group, utilizing serum C-terminal cross-linking telopeptides of type I~          collagen (CTX-I) (bone resorption) and N-terminal propeptides of type I procollagen~          (P1NP) (bone formation).~        -  Difference in loss of bone mineral density between the experimental group taking~          denosumab and the placebo control group, calculated as a percentage, in each of Gruen~          Zones 1 through 6, periprosthetic femur.~        -  Difference in loss of bone mineral density between the experimental group taking~          denosumab and the placebo control group, calculated as a percentage, in each of DeLee~          and Charnley's Zones 1 through 3, periprosthetic acetabulum.~      Exploratory objectives will be to assess difference in loss of bone mineral density in the~     contralateral, or non-operated femur for both experimental and control groups, and to~     determine the role that covariates such as weight, gender, age, baseline BMD, and implant~     type have on percent change in BMD at 12 months.~   "
46791|NCT02444572|"~     Comparison of thromboembolic events between Enoxa® and Lovenox® in patients undergoing~     digestive cancer and subjected to thromboprophylaxis.~   "
46792|NCT02444559|"~     The aim of this trial is to investigate if clonidine prolongs the duration of an adductor~     canal block. By using healthy volunteers the investigators can perform a bilateral adductor~     canal block and thereby control for a systemic effect to clarify if the effect is actually~     peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an~     adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a~     peripheral mechanism.~   "
46793|NCT02444546|"~     This phase I trial studies the side effects and the best dose of wild-type reovirus (viral~     therapy) when given with sargramostim in treating younger patients with high grade brain~     tumors that have come back or that have not responded to standard therapy. A virus, called~     wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells~     without damaging normal cells. Sargramostim may increase the production of blood cells and~     may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus~     together with sargramostim may kill more tumor cells.~   "
46794|NCT02444533|"~     The purpose of this study is to determine whether liposomal bupivacaine (long acting~     injectable anesthetic) provides greater post operative pain relief compared to the standard~     post operative pain regiment for tonsillectomy patients.~   "
46795|NCT02444520|"~     Medically unexplained symptoms (MUS) can be defined as physical symptoms that at present~     have no clear physical pathological cause. In primary care between 20 and 40% of patients~     have medically unexplained physical symptoms and in secondary care this figure rises to 50%~     in many specialties.~      This study design is a cross over randomized controlled trial with a waiting list to~     evaluate the acceptability and feasibility of studying a whole systems approach to care in~     general practice for adults with PPS. 'Integrated GP care' will be compared with treatment~     as usual (TAU) within a waiting list design.~      The aim of this study is to assess the feasibility of conducting a future randomized trial~     and to identify suitable primary outcome measures (outcomes that may be affected by~     'integrated GP care'), for a future trial evaluation and to inform the sample size/power~     calculation for such a trial.~   "
46796|NCT02444507|"~     To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product~     in healthy volunteers who reside in Taiwan.~   "
46818|NCT02444221|"~     To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at~     least one additional investigator-determined risk factor for stroke in real-life practice.~   "
46798|NCT02444481|"~     Open prospective multicenter phase IV study in patients presenting with symptoms of~     bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product~     information.~      Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory~     treatment.~      Objectifs of the study:~      Principal objectif:~      Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or~     mycotic vaginitis~      Secondary objectif:~      Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation~     of the correspondence of the efficacy on the symptoms and on the eradication of the germs.~      Numbers of patients previewed: 100 patients for evaluation of the efficacy~      Criteria of evaluation~      Principal criteria:~      Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical~     symptoms judged by the patient reduction or emlimination of bacteria and other germs the~     relationship between clinical and bacterial results~      Evaluation of tolerance~      Used Study Drug:~      Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin~     100000UI Application: vaginal application once daily in the evening for 12 days~      Study design:~      Visit 1:~      All patients presenting with the clinical symptoms, presenting all inclusion criteria and~     none of the exclusion criteria are included in the study at visit 1 and receive Polygynax~     treatment (one vaginal capsule once daily in the evening).~      A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological~     examination confirms an infection with germs sensible to the treatment with Polygynax the~     treatment is continued. If other germs not sensible to Polygynax are present, the patients~     is contacted to stop the treatment, to come back to a second visit to her gynacologist who~     will change the treatment. The other patients continue the treatment.~      Visit 3:~      After the treatment the patients come back to the last visit. A clinical evaluation and a~     vaginal smear for control is obtained.~   "
46799|NCT02444468|"~     This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic~     foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to~     investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby~     preventing delay of surgery due to swelling.~      The investigators will include patients with malleolar fractures that require surgery in two~     groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.~   "
46800|NCT02444455|"~     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem~     cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.~   "
46801|NCT02444442|"~     The purpose of this study is to assess the efficacy catheter-based renal denervation in~     reducing blood pressure in patients with resistant hypertension compared to a sham~     procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All~     participants will be switched to a single pill triple combination treatment prior to the~     procedure.~      A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35~     patients in the sham control arm.~      The duration of this study is 36 months.~   "
46802|NCT02444429|"~     Renal transplantation represents currently the best therapeutic alternative for end-stage~     renal failure, not only in terms of patient outcomes (better quality of life and longer~     survival), but also in terms of costs for the society.~      Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence~     of classic (i.e. clinically patent) acute cellular rejection episodes.~      Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the~     frequency of the loss of kidney transplants beyond the first year, as shown by the~     stagnation of grafts' half lives.~      Furthermore, the use of immunosuppressant combinations that are more and more powerful has~     an impact on adverse effects in recipients, including an increased incidence of infections,~     cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.),~     which are cause of significant morbi-mortality.~      In an attempt to improve on these disappointing outcomes, some teams have offered to perform~     screening biopsies: i.e. routine biopsies at specific time points during the follow up,~     irrespective of graft function. Their primary interest is to allow a pathological analysis~     of the graft at an early stage, i.e. when potential histological lesions allow for a~     diagnosis but before these lesions impact on graft's function. Indeed, it has been clearly~     demonstrated that therapeutic adjustments intended to protect the grafts are most effective~     when introduced early. There is a fairly broad consensus to perform these biopsies three~     months and one year after the transplantation. Performing screening biopsies has led to the~     identification of subclinical forms of rejection, i.e. graft infiltration by recipient~     immune effectors meeting the Banff histological criteria, but without increase in~     creatininemia.~      Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical~     rejection, which needs to be treated, the management strategy for the remaining 90% of~     patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. borderline~     changes, or ii) the complete absence of immune effectors in the graft is, poorly~     standardized.~      The investigators therefore propose to conduct a prospective randomized trial to answer~     these questions simultaneously by evaluating a strategy to optimize the immunosuppression of~     renal graft recipients based on the presence or absence of subclinical intragraft~     inflammatory infiltrates in the screening biopsy performed at 3 months post transplantation.~     Patients with borderline changes (sub-study A) will be randomized to receive a treatment for~     rejection (corticosteroid boluses). Patients without inflammation in their graft (sub-study~     B) will be randomized for corticosteroid withdrawal. Impact on graft function, progression~     of histological lesions and incidence of morbidity will be evaluated.~   "
46803|NCT02444416|"~     Context:~      Heart failure is associated with a high morbidity and mortality rate and represents a~     significant worldwide public health burden. In European countries, the total amount of the~     expenses related to heart failure represents 1 to 2% of the total health budget with 75%~     spent during hospitalizations, making heart failure the most expensive pathology in~     cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy.~     Hospital mortality is 2 to 4% the risk of death or readmission in the six months following~     hospitalization is high.~      Patients hospitalized for heart failure represent a very heterogeneous population in terms~     of etiologies, clinical presentations and/or co-morbidities. Consequently, this implies~     variable outcomes in terms of morbidity and mortality, probably due to their different~     prognostic factors. The precise spectrum of etiologies and prognostic factors of AHF in non~     selected populations has not been exhaustively studied and only a few predictive models~     concerning AHF have been validated.~      Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of~     therapeutic compliance are often quoted as being the factors triggering heart failure. Some~     triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem~     to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality~     and re-hospitalization rate.~      The complex relation between heart failure and acute renal failure is defined by the~     cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed~     with an acute renal failure at admission or with worsening kidney failure during~     hospitalization. It seems that heart failure and cardio-renal syndrome are two distinct~     entities with a different prognosis. The type of acute renal failure (functional, renal or~     post-renal) in these patients and the prognostic value of these etiologies is still not~     firmly established.~      A thorough determination of the etiologies and prognostic factors of AHF are necessary in~     order to allow the identification of high-risk patients and the improvement of heart failure~     management.~      Objectives:~        -  To create an observational registry of all patients hospitalized for a AHF~        -  To determine the precise prevalence of etiologies and the prognostic factors of AHF in~          a non selected population. Among the prognostic factors, to establish the specific role~          of acute renal failure~        -  To establish the optimal initial assessment of patients hospitalized for heart failure~        -  To validate and compare with prospective data the results of a retrospective cohort~          study carried out at the University Hospital of Geneva who established the~          re-hospitalization and mortality outcome of patients hospitalized for heart failure.~      Method:~      Creation of an observational registry associated with a biobank including patients~     hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the~     Departments of Specialties at the University Hospital of Geneva.~      Anticipated results:~        -  To identify the prevalence of the etiologies and the prognostic factors of the heart~          failure~        -  To establish the optimal initial assessment of the patients hospitalized for a heart~          failure. Among the prognostic factors, to establish the specific role of acute renal~          failure~        -  To validate and compare results of a retrospective cohort study carried out at the~          University Hospital of Geneva which established the re-hospitalization and mortality~          outcome of patients hospitalized AHF~        -  To improve the management of hospitalized patients with AHF with a robust~          identification of the etiologies and a better identification of high-risk patients.~   "
46828|NCT02444091|"~     Significant clinical improvements of ME/CFS symptoms were observed in two patients with~     long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for~     breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide~     for Hodgkin lymphoma.~      Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four~     weeks apart, in two of these with a significant clinical response.~      The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that~     ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse~     infusions four weeks apart, six infusions in total.~      The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as~     intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS~     symptoms and tolerability/side effects during 12 months follow-up will be registered, and~     additional tests will be performed to objectively register changes in physical ability~     during follow-up. Studies to investigate possible large vessel endothelial dysfunction and~     skin microvascular dysfunction will be performed before start of intervention and during~     follow-up.~   "
46804|NCT02444403|"~     Background: Policing practices are key drivers of HIV among people who inject drugs (PWID).~     This study prospectively examines the impact of a police education program (PEP) to align~     law enforcement and HIV prevention. PEPs incorporating HIV prevention, (including harm~     reduction programs like syringe exchange) have been successfully piloted in several~     countries but were limited to brief pre-post assessments; the impact of PEPs on policing~     behaviors and occupational safety is unknown. Objectives: Proyecto ESCUDO (Project SHIELD)~     aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as~     assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes~     in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes~     towards PWID, adverse behaviors that interfere with HIV prevention, and protective behaviors~     (secondary outcomes). The investigators hypothesize that, over the course of the 24-month~     follow-up, the PEP will be associated with significant declines in NSI incidence, improved~     knowledge of HIV and related infections, uptake of occupational safety measures, and~     decreases in behaviors that undermine HIV prevention (e.g. syringe confiscation, police~     harassment of PWID at opioid substitution therapy and syringe exchange programs).~     Methods/Design: ESCUDO is a Hybrid Type 2 design that simultaneously tests an intervention~     and an implementation strategy. Using a modified stepped-wedge design involving all active~     duty street-level police officers in Tijuana (N= ~1200), the investigators will administer~     one 3-hour PEP course to groups of 20-50 officers until the entire force is trained. NSI~     incidence and geo-coded arrest data will be assessed from department-wide de-identified~     data. Of consenting police officers, a sub-cohort (N=500) will be randomly sampled from each~     class to undergo pre- and post-PEP surveys with semi-annual follow-up for 2 years to assess~     self-reported NSIs, attitudes and behavior changes. Impact on PWIDs will be externally~     validated through a parallel cohort of Tijuana PWIDs. Discussion: This is the first trial to~     assess efficacy of a PEP on policing behaviors that place PWID and police at elevated risk~     of HIV and blood-borne infections. Findings may help bring PEPs to scale in the growing~     number of countries where policing is a documented driver of HIV acquisition.~   "
46805|NCT02444390|"~     This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit~     from treatment with everolimus in patients who are eligible for everolimus+exemestane~     treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane~     are prescribed within their approved indication as per usual practice and are not part of~     this trial.~   "
46806|NCT02444377|"~     Purpose: The purpose of this study would be to evaluate the effects of interval training on~     cardiovascular health, lipid profile and body composition in overweight and obese men and~     women.~      A secondary purpose will be to compare lab based measurements of body composition~     [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy~     (BIS) and ultrasound (US)]~      Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly~     assigned to a high-intensity short interval group (SIT), high-intensity long interval group~     (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak~     oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition~     will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry~     (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values.~     Participants assigned to either training group will undergo 3 weeks of interval training, 3~     days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest~     periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5~     bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of~     VO2peak (80-100% power output).~   "
46807|NCT02444364|"~     Participants will be persons with Type 2 Diabetes who are likely to have increased risk of~     bone fractures. The investigators believe this medication will enhance bone turnover.~      The investigators will use DXA measurements to evaluate bone density before and after~     subjects take the medication.~   "
46808|NCT02444351|"~     Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The~     purpose of this study is to evaluate the effect of botulinum toxin A injection into the~     gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We~     will compare pain score, insomnia severity, functional ability, patient satisfaction, and~     neurophysiological variables change using electrical stimulator between control~     (conservative management for spinal stenosis) and botox group (conservative management for~     spinal stenosis plus botox injection into the gastrocnemius muscle).~   "
46809|NCT02444338|"~     To study the safety and effectiveness of the MitraClip System in the treatment of clinically~     significant functional mitral regurgitation in patients with New York Heart Association~     (NYHA) Functional Class II to Class IV chronic heart failure.~   "
46810|NCT02444325|"~     The investigators primary objective is to conduct a pilot randomized trial to determine the~     effect of group prenatal care on self-care activities in women with diabetes.~   "
46811|NCT02444312|"~     A randomised controlled trial that will compare the effects of a brief benefit -finding~     writing intervention with an active control condition on quality of life and psychological~     health among informal caregivers.~   "
46812|NCT02444299|"~     Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for~     the treatment of various shoulder pathologies. It received CE Mark in June 2007.~      The aim of this study is to collect immediate medium and long term data on performance and~     safety of the implant, retrospectively as well as prospectively, from a consecutive series~     of patients to assess the patients' outcomes and functional status.~   "
46813|NCT02444286|"~     To evaluate the safety and efficiency of the MitraClip system in the treatment of patients~     with clinically significant mitral regurgitation with New York Heart Association (NYHA)~     Functional Class II to IV chronic heart failure.~   "
46814|NCT02444273|"~     The primary outcome of this study is to demonstrate the feasibility of a prehabilitation~     program at Barnes Jewish Hospital for liver transplant candidates. Those patients who~     consent to participate in the study and are placed on the transplant list will be randomized~     into either the control or intervention group. The intervention group receives a~     personalized home exercise program along with weekly phone calls to provide coaching,~     mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant~     follow up will be compared among the two study groups. The secondary outcomes include:~     normative data of functional measures for patients with end stage liver disease and to~     determine the effect size for future research on prehabilitation in the patient population.~   "
46815|NCT02444260|"~     The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local~     Anaesthesia alone versus Local Anaesthesia and Conscious Sedation~      Specific study objectives are to determine the effect of conscious sedation on:~      (i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative~     complications (v) postoperative functional status (vi) short-term postoperative~     complications (vii) long-term postoperative complications~   "
46816|NCT02444247|"~     The purpose of this study is to understand how to make exercise more attractive to people.~   "
46819|NCT02444208|"~     Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered~     the standard of care for reducing cocaine use and preventing relapse. However, even with~     intense behavioral interventions, rates of relapse to cocaine use are discouragingly high~     (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to~     improve treatment outcomes for cocaine-use disorders. The overarching goal of this project~     is to assess the feasibility, acceptability and initial efficacy of an innovative~     cocaine-based inhibitory-control training procedure. This goal will be accomplished through~     the conduct of a Stage I pilot trial. Cocaine-dependent participants will be enrolled and~     randomized to receive inhibitory-control training to cocaine or neutral images~     (N=20/condition). This proposed intervention, cocaine based inhibitory-control training,~     will be delivered using an innovative computer program which teaches cocaine abusers to~     inhibit a pre-potent response to cocaine or neutral cues. The primary hypothesis is the~     proposed procedures are feasible and acceptable to the participants. Feasibility will be~     assessed by determining time needed to enroll the target sample; adaptive randomization~     outcomes; participant attendance, completion and adherence to study procedures.~     Acceptability will be determined using a Treatment Acceptability Questionnaire. The~     secondary hypothesis is that participants receiving cocaine-based inhibitory-control~     training will reduce their drug use to a greater extent than their counterparts in the~     neutral-image condition. Reduced cocaine use will be demonstrated by fewer positive-urine~     samples using qualitative urinalysis and a reduction in levels of benzoylecgonine as~     determined by quantitative urinalysis (i.e., ELISA). The third hypothesis is that~     participants receiving cocaine-based inhibitory-control training will show improved~     inhibitory control and neurocognitive functioning relative to their counterparts in the~     neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning~     will be demonstrated using a battery of clinical instruments and laboratory tasks. The~     proposed research is highly innovative in that it will provide critical information~     regarding the feasibility, acceptability, initial efficacy of cocaine-based~     inhibitory-control training to reduce drug use and improve inhibitory control and~     neurocognitive functioning in cocaine-dependent participants. Cocaine-based inhibitory~     control training is also easy to administer (i.e., 15 minutes), inexpensive, need not be~     administered by a clinician, and could easily be incorporated into current behavioral or~     community-based treatment approaches to enhance sustained abstinence, thereby quickly~     impacting clinical research and practice.~   "
46820|NCT02444195|"~     The purpose of this study is to evaluate the effectiveness of self-administered~     perioperative guided imagery to reduce perioperative distress in gynecologic oncology~     patients undergoing surgical management for a presumed cancer diagnosis.~   "
46821|NCT02444182|"~     Some probiotics have been shown to have preventive effects on infectious diseases and~     allergies. Because their long-term enhancement of the immune responses of children, they~     have been recommended for infants in some countries. The most promising ones seem to be the~     combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic~     microbes are mainly ingested orally and the gastrointestinal tract is thus the primary~     target organ for them. However, the mouth is the first part of the gastrointestinal tract.~     Most probiotics are in theory cariogenic, thus their effects on oral health should be known.~     Several probiotics decrease levels of salivary mutans streptococci (MS), but in other~     respects very little is known about their effects on the oral microbiota. Also effects of~     probiotics on dental plaque should be studied. This study aims to find out the effects of~     the combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a~     mixture of them on the amount of plaque and gingival health~   "
46822|NCT02444169|"~     A retrospective study to evaluate the Ulthera® System for its potential interaction with~     toxins and fillers. Up to 500 subjects will be enrolled.~   "
46823|NCT02444156|"~     Primary research question: What is the effect of indoor rowing, under the ideal~     circumstances of a laboratory setting, on glucose control in adults with impaired glucose~     control?~      Secondary research question: Is it possible to develop a full-scale study of the benefits of~     indoor rowing under the usual circumstances of a community setting?~      Why? It is good practice to conduct a small pilot study before embarking on an expensive~     full-scale study.~      What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise~     per week are necessary to meet prevailing recommendations for adults with impaired glucose~     control. Around 120 minutes of indoor rowing per week might be a less time-consuming~     alternative to prevailing recommendations because indoor rowing involves a combination of~     aerobic and resistance exercise.~      Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation,~     such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last~     year, will not have exercised regularly in the last six months, and will not be taking any~     form of diabetes medication other than metformin. Eligible volunteers will have stable~     weight and a body mass index of 25-40.~      Where and how? Before and after the exercise intervention, glucose control (postprandial~     blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac~     function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention,~     participants will use an indoor rower three times per week for 12 weeks at Leicester~     Diabetes Centre. Participants will be taught how to row correctly and the duration and~     intensity will gradually increase. In order to inform the design of a full-scale trial,~     recruitment rate will be assessed, adherence will be monitored, and a third party will~     interview participants to find out if the intervention and assessments are feasible and~     acceptable.~   "
46824|NCT02444143|"~     Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day~     dosing regimen. This formulation has the potential to improve compliance. Current dosing~     recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day~     administered once daily in the morning. There are no specifications on appropriate dosing in~     obese patients or on whether to use actual, ideal or and adjusted weight. It will be~     advantageous to understand the pharmacokinetics of this medication in the obese to determine~     the appropriate dosing regimen. In this study, obese patients will be randomized to receive~     tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or~     adjusted body weight (aBW).~   "
46825|NCT02444130|"~     The main purpose of this study was to identify electrophysiological predictive markers of~     post-correction visual comfort for presbyopic patients.~   "
46826|NCT02444117|"~     This study aims to identify clinical and biological markers which would allow to evaluate~     precisely the evolution of children with autism spectrum disorders throughout intervention.~   "
46827|NCT02444104|"~     To evaluate and to validate accuracy, precision and trending ability of blood pressure and~     cardiac output measurement by applanation tonometry in cardiological patients having:~        -  atrial fibrillation~        -  severe impaired leftventricular function~        -  severe aortic valve stenosis~        -  patients having left ventricular assist device~      Experimental measurement: continuous blood pressure measurement and cardiac output~     measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA)~     Control measurement: gold-standard continuous blood pressure measurement is performed by~     invasive blood pressure measurement by arterial cannulation and cardiac output reference is~     assessed by transcardiopulmonary thermodilution~   "
46829|NCT02444078|"~     This is a cluster randomised controlled trial composed of two research arms: exercise~     training group (experimental group) and a social activity group (control group).~   "
46843|NCT02443896|"~     The purpose of thus study is to assess the feasibility and inform the planning of a proposed~     definitive randomised controlled clinical trial to investigate the efficacy of sealing~     permanent molars in children requiring caries related extractions under a chair General~     Anaesthetic.~   "
46844|NCT02443883|"~     The main purpose of this study is to evaluate the safety and feasibility of administering~     higher doses of ramucirumab in participants with gastric cancer.~   "
46845|NCT02443870|"~     The long-term changes of bladder function in individuals with lower urinary tract~     dysfunction will be investigated. Patients presenting for regular urodynamic examination of~     bladder function will be included. Bladder diary details and urodynamic data will be~     collected in order to investigate bladder function.~   "
46830|NCT02444065|"~     Treatments for bulimia nervosa (BN) have relatively high rates of nonremission and relapse,~     meaning that improving treatments is a high priority in this area. Rapid response to~     treatment -cessation of binge eating and vomiting symptoms within the first weeks of~     treatment - is a robust predictor of improved post-treatment outcomes and lower relapse~     rates, but no study has tried to facilitate rapid response as a means of improving treatment~     outcomes. The present study responds to this gap in the literature by testing a 4-session~     CBT-based individual intervention for rapid response (i.e., CBT-RR), designed to augment~     standard day hospital (DH) treatment for BN and Purging Disorder (PD) by focusing on~     strategies and skills for rapid symptom interruption. CBT-RR will be compared to a~     matched-intensity augmentative motivational interviewing (MI) intervention. Participants~     will be recruited from a hospital-based day program for eating disorders, and will be~     randomly assigned to one of the two conditions in addition to the DH as usual. participants~     will be assessed at pre-intervention, post-intervention, week 4 of DH, post-DH, and 6 months~     follow-up. It is hypothesized that compared to those who receive MI, patients who receive~     CBT-RR will be more likely to exhibit a rapid response to day hospital treatment (i.e., </=~     3 binge eating and/or vomiting episodes in the first 4 weeks). It is further hypothesized~     that patients who receive CBT-RR will exhibit fewer binge eating and/or vomiting episodes at~     post-DH and at 6-month follow-up. Potential mediators and moderators of these hypothesized~     treatment effects will be examined on an exploratory basis, including self-efficacy,~     motivation, and hope (potential mediators), and emotion regulation, depression, cognitive~     psychopathology of eating disorders, and working alliance with the therapist (potential~     moderators).~   "
46831|NCT02444052|"~     The purpose of this study is to evaluate clinically, histologically and radiographically the~     healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel~     Biocare,), a low-cost allograft material, 90 days following exodontia.~   "
46832|NCT02444039|"~     The objective of the study is to compare the ease of use and performance of the SL-D301 with~     the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.~   "
46833|NCT02444026|"~     The aim is, in a randomized controlled trial, to test the feasibility and evaluate the~     efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US~     cancer patients, in a large sample of Danish breast cancer survivors who are experiencing~     significant sleep problems 0-3 years after treatment. The investigators aim to test the~     following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy~     (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep,~     fewer awakenings during the night, improved sleep efficiency, increased subjective sleep~     quality, and improved quality of life after the intervention, when compared to a waiting~     list control group. The investigators also aim to explore a number of possible moderators of~     the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and~     mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).~   "
46834|NCT02444013|"~     The purpose of this study is to determine whether periprocedural administration of folic~     acid is effective in the prevention of contrast induced nephropathy in patients undergoing~     coronary CTA/angiography/angioplasty.~   "
46835|NCT02444000|"~     Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of~     neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk~     of neurocognitive deterioration without impairing overall survival.~   "
46836|NCT02443987|"~     The primary aim of this study is to compare, in women undergoing tension-free vaginal tape~     (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of~     first void following surgery between a group of patients who received intravenous fluids to~     those who did not.~   "
46837|NCT02443974|"~     Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the~     most commonly affected joint in this population. Knee braces are often used to prevent~     common problems in knees during daily activities. The purpose of these devices is to~     decrease pain and improve functionality. In the literature some studies have tested the~     effectiveness of unloader brace for valgus or varus. However, the braces most used in the~     investigators' clinical setting and the less costly ones have not been described in quality~     studies in the literature. There are only few studies on this subject and they are~     methodologically inadequate. There are no studies that compared the effectiveness between~     the knee brace with metal hinges (no alignment) and knee brace without metal hinges.~     Objective: To evaluate the effectiveness of knee braces on pain, function and quality of~     life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain~     scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120~     met the eligibility criteria and were randomized to the groups: without metal hinges, with~     metal hinges or control group. The groups without and with metal hinges received knee brace~     and were instructed to use it in daily activities, every day, during three months.~     Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36)~     were done at baseline and after 45, 90 and 180 days by a blinded assessor.~   "
46838|NCT02443961|"~     Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth,~     15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is~     increasing due to the advances in neonatology, with a rise in the survival of smaller and~     more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal~     chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These~     factors lead to a pathological development of the lung and pulmonary vessels, developing~     secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this~     generates a important sanitary burden and a decrease in life quality. Multiple experimental~     models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also~     recently some clinical trials have tried this therapy on premature newborns with promising~     results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions.~     Methods: The investigators have designed a clinical trial to evaluate the feasibility and~     security of MSC therapy in patients at high risk of developing BPD.~   "
46839|NCT02443948|"~     This observational study is proposed to evaluate if the trend in the levels of cf-DNA~     evaluated on a sample of peripheral blood may be related to different clinical behaviors of~     the disease monitored by radiological investigations conducted.~   "
46840|NCT02443935|"~     Combination antiretroviral treatment (cART) effectively suppresses virus replication and~     partially restores immune functions. However, cART cannot cure HIV infection.~      This study aim to investigate whether the antiviral immune response can be enhanced and/or~     viral transcription reactivated with MGN1703. MGN1703 is an agonist to toll-like receptor~     (TLR) 9. Activation of TLR9 has been shown to augment innate and adaptive immune effector~     functions, most notably enhanced NK cell and T cell functions.~      Furthermore, TLR9 agonists have been shown in vitro to reactivate viral transcription in~     latently infected cells, potentially leading to enhanced recognition of infected cells by~     the immune effector cells.~   "
46849|NCT02443818|"~     It was found that people who have an excessive growth in one or more parts of their body and~     normal growth in other parts, may have a change in genes responsible for controlling cell~     growth. This genetic discovery identified a possible treatment for this overgrowth, called~     Sirolimus.~      This is a pilot study, which help the investigators prepare a larger international study,~     which will aim to determine whether a treatment based Sirolimus is able to stop the~     excessive growth of one or more parties of their body in people who carry a genetic change~     in the PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).~   "
46850|NCT02443805|"~     The objective of this study is to assess the efficacy and safety of 12 months of treatment~     with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents~     with HDM-associated allergic rhinitis.~   "
46851|NCT02443792|"~     RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical~     circumcision under local anesthetic with suturing.~   "
46852|NCT02443779|"~     The purpose of this study is to examine if a correlation exists between findings from brain~     imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT~     imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the~     retina as detected by optical coherence tomography (OCT) in recently diagnosed and more~     advanced Parkinson's disease patients.~   "
46853|NCT02443766|"~     Over 2 decades scientists have been studying the effect on brain function from meditation~     practices. The purpose of this study is to measure the effect of a meditation retreat~     program on serotonin and dopamine transporter binding and changes in cerebral blood flow.~     The retreat program that will be followed is a weeklong retreat called the Ignatian Retreat.~   "
46854|NCT02443753|"~     This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and~     obese subjects with type 2 diabetes. The barbless second generation device is being~     developed as a means to reduce the incidence of adverse events associated with the barbs of~     the predicate device while maintaining a similar efficacy profile as measured by changes in~     weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human~     will primarily evaluate preliminary safety, tolerability and efficacy of the new design.~     Because of the new design and its first study in human subjects, only a 3 month implant~     duration will be evaluated in this study.~   "
46855|NCT02443740|"~     This is a First in human (FIH) single ascending dose study to evaluate the safety,~     tolerability and pharmacokinetics (PKs) of PF-05251749 following single oral doses in~     healthy human subjects~   "
46856|NCT02443727|"~     The main objective of this project is to study whether intranasal oxytocin (OT) affects how~     young adults perceive and attend to infant and adult faces. Based on existing research the~     investigators predict that oxytocin will facilitate the allocation of attentional resources~     on infant faces (compared to adult faces). The investigators also predict that oxytocin will~     enhance the activity of reward neural-networks associated with the perception of infant~     faces. The behavioral effects of OT (visual attention and face recognition) will be measured~     with eye-tracking while participants look at photographs of adult and infant faces.~     Neurological effects (the activity of emotion and reward networks) will be measured with~     functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a~     computer screen.~   "
46857|NCT02443714|"~     Needle-free jet injector provides an alternative for patients with diabetes treated by~     insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD)~     profiles of lispro administered by jet injector and conventional pen.~   "
46858|NCT02443701|"~     Background: Volleyball players constantly perform vertical jumps, the higher the height of~     the jump is better sports performance of these players. Several methods have been tested to~     improve jumping performance in these players. It will be investigated the addition of~     electrical stimulation and phototherapy to jump training in volleyball athletes. DESIGN:~     randomized controlled trial. METHODS: This study will be conducted with 36 male athletes~     volleyball with minimum experience of 12 months sport. Will be randomized and assigned to 3~     groups (control group, NEMES group and group phototherapy). All 36 healthy volleyball~     athletes who passed the initial selection and agreed to participate in the study, conduct a~     muscle strength and jump training program, which is held in both legs simultaneously. The 12~     healthy athletes electrical stimulation group will perform the same training program~     described above, but strength training is associated with electrical stimulation. The 12~     healthy athletes participating in the phototherapy group will undergo a phototherapy~     protocol before performing the strength and jump training. All selected participants will~     undergo an assessment of muscle strength of knee extensors and evaluate the jump. These~     evaluations were baseline, 6 weeks and 8 weeks after baseline.~   "
46859|NCT02443688|"~     This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the~     safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.~   "
46860|NCT02442674|"~     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases~     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic~     or hypervolemic hyponatremia.~   "
46861|NCT02442661|"~     This research study is performed to compare the accuracy of two methods of lymph node~     evaluation: research method versus standard method. Standard method is what is usually~     performed as standard of care where the radiologist evaluates the images overall and decides~     whether each node seen should or should not be biopsied. In the research method, a second~     radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a~     small specific checklist of ultrasound appearance to determine whether each node should or~     should not be biopsied. Results of both the standard and research method will be used to~     decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node~     evaluation by standard method and subsequent lymph node biopsy are part of the standard~     clinical care. It is less likely but possible that the research method may identify~     additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.~   "
46862|NCT02442648|"~     The primary purpose of this study is to provide a preliminary evaluation of the safety and~     potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized~     kidney transplant candidates.~   "
46863|NCT02442635|"~     This proposal aims to expand non-pharmacologic options for the control of symptoms during~     chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a~     secondary focus on fatigue.~   "
46864|NCT02442622|"~     To determine if the addition of Astym treatment to traditional therapy produces a more~     positive outcome then traditional therapy alone for the treatment of de Quervain's~     tenosynvitis. Two groups will be examined with one group receiving traditional therapy and~     the other group receiving traditional therapy in addition to Astym treatment protocol.~   "
46865|NCT02442609|"~     Patients need information for perioperative period and internet may be an interesting~     alternative.This study analysed by questionaire what does patient look on internet:~     information of perioperative period and specifically for anesthesia. Questionaire (8~     questions) are distributed to the patient before surgery and after they were prepared by~     surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of~     internet for anesthesia information.~   "
46866|NCT02442596|"~     The aim of the project is to perform a multinational, prospective, observational study on~     IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given~     to epidemiology and outcomes.~   "
46867|NCT02442583|"~     Interview colorectal cancer survivors and use this input to create a brochure intended to~     guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors~     review and comment on a draft of the brochure. A third group of colorectal cancer survivors~     will wear an Actigraph activity monitor for one week, then receive feedback on their~     activity level with the brochure. After one month this group will be surveyed by telephone~     regarding their use of the brochure, and their physical activity level.~   "
46868|NCT02442570|"~     The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple~     sclerosis.~   "
46869|NCT02442557|"~     The purpose of this study is to determine safety and appropriate dose of DC-TAB for~     selective immune tolerance induction in humans.~   "
46870|NCT02442544|"~     The gut microbiome is increasingly recognized as a contributor to disease states. In type 1~     diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability,~     inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gut~     microbiota and could potentially improve insulin sensitivity in children with type 1~     diabetes. This pilot study aims to determine the feasibility of a 12-week dietary~     intervention with prebiotic fiber in children with type 1 diabetes. The investigators~     hypothesize that consumption of prebiotic fiber will alter gut microbiota and intestinal~     permeability, leading to improved glycemic control. Prebiotic fiber is a potentially novel,~     inexpensive, low-risk treatment addition for type 1 diabetes that may improve glycemic~     control by changes in gut microbiota, gut permeability and inflammation.~   "
46871|NCT02442531|"~     The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec®~     docetaxel that can be given in the treatment of patients with solid tumours.~   "
46872|NCT02442518|"~     The accuracy of sonographic prenatal detection of invasive placentation is unclear. The~     objective of this prospective, multicenter, observational study is to assess the performance~     of ultrasound for prenatal identification of invasive placentation in women with placenta~     previa.~      This study involves more than 25 hospitals in Italy.~   "
46873|NCT02442505|"~     This study will use an automated blood pressure monitor (Microlife WatchBP03) with an~     inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with~     an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial~     fibrillation. This study will compare the Microlife device detected atrial fibrillation~     episodes to the pacemaker detected atrial fibrillation episodes.~   "
46874|NCT02442492|"~     Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high~     risk of perinatal morbidity and mortality. In association with reduced circulating placental~     growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling~     of the maternal uteroplacental arteries. There is no known treatment for placental IUGR.~     Management involves intensive fetal surveillance with delivery with evidence of serious~     fetal compromise. However, remote from term, delivery is associated with significant~     perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of~     IUGR-affected pregnancies and may represent a novel therapy.~   "
46875|NCT02442479|"~     Resistance training has shown the most promise among interventions aimed to combat aging~     muscle atrophy as it enhances strength, power, and mobility function, but induces varying~     degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial~     5-year funding period of this award (2001-2006). In the subsequent 5-year funding period~     (2007-2012), the investigators built on this prior work by using a dose-response approach in~     older adults - ultimately to optimize the treatment of age-related muscle atrophy. The~     investigators tested four, long-term resistance training prescriptions in older (60-75 yr)~     women and men to determine which prescription maximizes mechanisms driving muscle regrowth.~     One of the innovations in this project was the use of a 4-wk pre-training program to reach a~     plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from~     which both mechanisms of measurable muscle hypertrophy and functional consequences of~     hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent~     experimental period. A randomized design was used to test the overarching hypothesis that a~     novel program of mixed strength and power training would optimize the anabolic environment~     to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested~     with three specific aims.~   "
46876|NCT02442466|"~     Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was~     preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration~     and relevance of results observed in pre-clinical studies to the human disease.~   "
46892|NCT02443493|"~     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the~     treated area, also known as radiodermatitis (RD).~      Currently, there is a wide variety of strategies to manage RD, including creams, gels,~     ointments, wound dressings. However, up to now, there is still no comprehensive,~     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a~     promising, non-invasive technique for treating RD. In a recent pilot study conducted in our~     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in~     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot~     study was the first prospective study investigating the potential of LLLT for RD. In the~     current study, we want to investigate the efficacy of LLLT as a tool for the prevention of~     radiodermatitis in breast cancer patients.~   "
46877|NCT02442453|"~     Periodontitis is initiated by microbial biofilm but its progression is mediated by an~     abnormal host response to biofilm microorganisms.~      In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen~     species (ROS) play an important role. Imbalance between antioxidant defense system of body~     and ROS lead to a deleterious situation called oxidative stress.~      Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas~     malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS~     have short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by~     measuring the concentration of biomarkers of tissue destruction.~      For treating periodontal disease, conventional mechanical therapy comprising of scaling and~     root planing (SRP) along with timely maintenance has been a gold standard and any other~     therapy considered for treating periodontitis should always be used as an adjunctive and~     never in lieu of it.~      Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism~     of action of curcumin is twofold-its role as a strong antioxidant and as a strong~     antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional~     benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased~     oxidative stress. Therefore the clinical application of a natural antioxidant in the form of~     curcuma longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment~     of chronic periodontitis.~   "
46878|NCT02443675|"~     Observational Study of Pain Reduction in Late Stage Cancer Patients Receiving Low-Dose~     Chemotherapy~   "
46879|NCT02443662|"~     Children born with univentricular heart will go through step surgery and end up with a~     Fontan circulation. A circulation with cause problems with body fluid balance.This project~     will evaluate changes in interstitial colloid osmotic pressure in patients 10 year after~     completion of a three step Fontan surgery. This project will evaluate whether increased~     micro vascular leakage and change in interstitial colloid osmotic pressure are present in~     patients after ten years with a Fontan circulation.~   "
46880|NCT02443649|"~     Insomnia is a significant problem affecting 10 to 20% of US population. Long-term~     pharmacological treatments are not recommended due to side effects, with therapy and sleep~     hygiene education often employed as alternatives. Use of mind-body approaches for insomnia~     is increasing. One of the most promising mind-body approaches for alleviating sleep problems~     is hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but~     sleep was rarely assessed as primary outcome and studied populations were diverse. Further,~     it remains unclear who the best candidates for benefitting from hypnosis are. To address~     some of the gaps in the current knowledge, the study evaluates whether 1) an addition of~     hypnotic suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program~     increases the effectiveness of the OSH using objective and subjective assessments and 2)~     determines characteristics associated with hypnotic responsiveness.To address these goals a~     randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1~     month follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and~     allocated to one the two groups: 1) experimental group receiving during the intervention~     visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for~     sleep improvement and 2) a control group receiving at the intervention visit the OSH only.~     Hypnosis session for sleep improvement for the control group will be offered at the end of~     the follow-up study visit (conducted after 4 weeks post-intervention) after completing all~     follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep,~     personality traits and daily function of the participants will be assessed. Further, after~     the baseline and one week before the follow-up visit subjects will wear a watch-like~     actigraphic device monitoring their sleep patterns at home and will complete sleep diary.~      The knowledge gained from this study will inform the literature and clinicians about~     usefulness of hypnosis for insomnia sufferers and will help identify the population of~     insomnia sufferers most likely benefit from use of hypnosis for sleep~   "
46881|NCT02443636|"~     While effective interventions for depression exist, their success rates are unsatisfactory~     and their provision is haphazard. The Canadian Depression Research and Intervention Network~     (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of~     outcomes for youths, adults and seniors with depression across the Maritimes. The~     investigators will establish an integrated system of assessment, treatment, research and~     education related to depression with the active involvement of those with lived experience.~     The establishment of a patient registry is a key step that will facilitate evaluation and~     reform of current services, integration of patient choice and community resources into~     treatment programs, monitoring long-term outcomes, and development of more effective~     treatment approaches through research. The registry will facilitate research that will~     include validation of new diagnostic and outcome measurement tools, low-cost clinical trials~     and collaborative projects with national and international partners. Educational programs~     will involve training the next generation of researchers, those with lived experience,~     clinicians, and health system managers in critical appraisal and will facilitate their~     involvement in research. The registry, the proposed systematic measurement of outcomes and~     the broad dissemination of information and skills will improve the quality of research and~     of care as well as the experience of patients and their families.~      The need for a registry: It is increasingly recognized that major advances in the treatment~     of mental disorders will require large scale clinical research. Recently demonstrated ways~     of completing large-scale research with finite resources include the routine use of~     electronic health records (EHR), data linkage and randomized registry trial. Use of EHR is~     the most efficient way of rapidly obtaining large amounts of information. However, EHR~     cannot completely exclude confounding by indication and other unmeasured variables.~     Therefore, tests of treatment effects require experimental designs that cannot be replaced~     by routine health records data. The gold standard for testing the effects of treatment in an~     unbiased way is the randomized controlled trial (RCT), where measured and unmeasured~     confounders are balanced through the randomization process and any remaining confounding is~     due to chance alone. RCTs are valued as the highest level of evidence, but are costly and~     take significant time to be completed, partly because of the need to screen a large group of~     individuals to identify eligible participants.~      The most efficient unbiased test of interventions, new treatment modalities and novel ways~     of treatment delivery is a method that combines EHR use with the randomized controlled trial~     (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a~     registry of individuals with available information to identify a large number of individuals~     suitable for an RCT. The RRT approach is efficient especially if the same information (e.g.~     diagnosis and treatment history) is used repeatedly for different purposes. The same~     information can be used for clinical purposes, service improvement and multiple research~     projects. RRT will allow obtaining answers about the efficacy of new treatments and~     management strategies significantly faster and at a much lower cost than traditional RCTs.~     Therefore, the investigators propose to establish a registry that has the capacity to~     conduct RRTs. The proposed registry will be integrated with similar efforts across Canada.~     Jointly, this collaborative network of registries will facilitate fast and economical~     testing of new treatments, which is urgently needed to advance the therapeutic options for~     people with depression and related conditions.~   "
46882|NCT02443623|"~     Objectives:~        -  To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an~          immune response resulting in high anti-vaccinia antibody titers. The collection of~          donor plasma will be used in the manufacturing of Vaccinia Immune Globulin Intravenous~          (VIGIV).~        -  To ensure the safety of plasma donors vaccinated with ACAM2000 through the~          implementation of risk factor screening procedures and the collection of~          post-vaccination safety data.~   "
46883|NCT02443610|"~     The aim of this study is to evaluate the frequencey and the determinants of postpartum major~     complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity~     hospitals of Finistère (Bretagne - France)~   "
46884|NCT02443597|"~     Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for~     aneuploidy risk assessment.~   "
46885|NCT02443584|"~     This is a randomized, control group design of pharmacogenetic implementation in a mental~     health population of subjects taking anti-depressants and/or anti-psychotics with a new or~     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive~     Disorder Not Otherwise Specified (DDNOS).~   "
46886|NCT02443571|"~     This retrospective observational multi centered study has been established to collect the~     clinical experience relating to the administration of Fluciclovine 18F employed in both~     investigator initiated studies and named patient/compassionate use programmes in up to 5~     sites.~   "
46887|NCT02443558|"~     CSI:Brainwave is a multidisciplinary neurophysiological project, developed by the Lab of~     Medical Physics, School of Medicine, Aristotle University of Thessaloniki and supported by~     two Neurosurgical Departments. The project officially commenced on April 2014 and the first~     year was awarded the 2013 Mario Boni Research Grant by the Cervical Spine Research~     Society-European Section (CSRS-ES). The website for the project can be accessed at~     http://medphys.med.auth.gr/content/csi-brainwave.~      The investigation's primary objectives include the development, testing and optimization of~     a mountable robotic arm controlled with wireless Brain-Computer Interface, the development~     and validation of a self-paced neuro-rehabilitation protocol for patients with Cervical~     Spinal Cord Injury and the study of cortical activity in acute and chronic spinal cord~     injury.~   "
46888|NCT02443545|"~     This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more~     information about the safety and efficacy of deferiprone in patients with sickle cell~     disease or other anemias who suffer from iron overload caused by regular blood transfusions.~   "
46889|NCT02443532|"~     Patients with type 1 diabetes aged 15-65 years without major complications will be~     randomized either to usual care or to a structured group education program, with 6 four-hour~     weekly interactive sessions devoted to diabetes management. The principal endpoint will be~     the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality~     of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.~   "
46890|NCT02443519|"~     This randomized clinical trial aims to examine the effect of a standardized 8-week course of~     Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people~     with migraine.~   "
46893|NCT02443480|"~     The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the~     frequency of verbal cues, body positioning and anxiety levels with descriptions for each of~     the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different~     observers and to determine any correlation with patient satisfaction.~   "
46894|NCT02443467|"~     This was an open-labeled, multi-center, prospective, non-comparative study of the safety of~     Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who~     had previously received antracycline therapy before or after surgery.~   "
46895|NCT02443454|"~     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device~     in Short and Long-term after kidney transplantation.~   "
46896|NCT02443428|"~     The purpose of this prospective observational registry is to monitor safety of eribulin in~     routine clinical practice. Additionally, this study will also assess the effectiveness of~     eribulin in real-life settings.~   "
46897|NCT02443415|"~     The purpose of this study is to assess brain and memory changes in patients with~     uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))~   "
46898|NCT02443402|"~     The purpose of this study is to compare sitagliptin and placebo for the prevention of high~     blood glucose during surgery.~   "
46899|NCT02443389|"~     Introduction:~      Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level~     neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI~     have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK~     sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized~     the need to improve collaborations between neonatologists and nephrologists within and~     across centers. The investigators have created a multi-institutional, multi-disciplinary~     group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs~     identified at the workshop: AWAKEN is the inaugural study of this new collaboration.~        1. Development of a standardized evidence-based definition of neonatal AKI~        2. Evaluation of risk factors that predispose neonatal to AKI~        3. Investigation into how fluid provision/ balance impacts biochemical and clinical~          outcomes~   "
46900|NCT02443376|"~     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device~     before and immediately after the end of the dialysis session.~   "
46901|NCT02443363|"~     The study included 300 patients who are post-kidney transplantation (> 3 months and <10~     years). An analysis of body composition using bioelectrical impedance, calculated BMI and~     serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the~     formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.~   "
46902|NCT02443350|"~     Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in~     recent years，producing the specific IgG antibody induced by the NMDA receptors.It is the~     most common curable disease among the non infectious-autoimmune encephalitis,usually has~     been misdiagnosed as other causes of encephalitis.Our previous study found that there are~     differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as~     the sex ratio, the rate of combined tumor and clinical manifestations.As a new found~     disease,the incidence rate has been underestimated.Therefore,to establish the Registry~     Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This~     study will combine Beijing area's hospitals and foreign experts,depending on multicenter,~     prospective and registry method,to understand the incidence in Beijing area,to summarize and~     analyze the clinical data of patients.So,there will make a solid foundation for the~     subsequent Beijing area detection platform and other research.~   "
46903|NCT02443337|"~     The main purpose of this study is to evaluate the safety and activity of the study drug~     known as LY3023414 in combination with necitumumab in participants with metastatic squamous~     non-small cell lung cancer (NSCLC).~   "
46904|NCT02443324|"~     The main purpose of this study is to evaluate the safety and preliminary efficacy of the~     combination of the study drug known as ramucirumab plus pembrolizumab in participants with~     locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ)~     adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the~     urothelium, or biliary tract cancer (BTC).~   "
46905|NCT02443311|"~     Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and~     relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by~     targeting pathophysiological pathways, and to provide long-term management by reducing~     recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release~     inhibitor; considering its mechanism of action it is reasonable to theorize that~     pimecrolimus may effectively treat OLP without the potential side effects that are~     associated with corticosteroids.~   "
46906|NCT02443298|"~     The objectives of this trial are primarily to evaluate the efficacy and safety of BI~     655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in~     severe asthma patients. The primary endpoint is time to first asthma worsening during the~     planned 24 week treatment period for active vs. placebo treated patients on top of standard~     of care therapy. Upon demonstration of a meaningful clinical response, another important~     objective is the identification of biomarkers that can be used to target patients who will~     likely respond to treatment with BI 655066/ABBV-066 (risankizumab).~   "
46907|NCT02443285|"~     Current European and most other international guidelines recommend the use of a~     third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or~     fluoroquinolones as an alternative choice .~      These recommendations are based mainly on clinical trials that were very often conducted a~     decade or more ago, and on the assumption that E. coli would be involved in nearly half of~     the cases.~      The microbial etiology of SBP remains relatively constant; however, the antibiotic~     resistance rate especially for third-generation cephalosporins (including cefotaxime and~     ceftazidime), ciprofloxacin, and ofloxacin increased dramatically .~   "
46908|NCT02443272|"~     The purpose of this study is to compare abscess drainage utilizing the vessel loop technique~     in children to the standard incision and drainage technique with the endpoint to determine~     if rates of treatment failure are non-inferior.~   "
46917|NCT02443155|"~     This trial is conducted globally. The aim of this trial is to assess the clinical~     proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in~     adult subjects with newly diagnosed type 1 diabetes mellitus.~   "
46909|NCT02443259|"~     Hypertensive disorders are the most common medical complications in pregnancy and major~     causes of maternal, fetal, and neonatal morbidity and mortality. Fifty percent of~     hypertensive disorders of pregnancy are defined as pre eclampsia, the most important~     manifestation of the disease.~      Preeclampsia is also a significant risk factor in the development of IUGR and represents the~     most common cause of IUGR in the nonanomalous infant. The incidence of thrombocytopenia,~     neutropenia and Bronchopulmonary dysplasia is also increased in neonates with preeclampsia.~      The neurodevelopmental outcomes infants exposed to preeclampsia are highly variable. The~     study by Gray et al showed that preeclampsia is associated with a decreased risk of cerebral~     palsy. They also found a protective effect of maternal preeclampsia on cerebral palsy~     regardless of exposure to magnesium sulfate. However, contrary to this, study conducted by~     Shao-Wen Cheng et al has showed that infants born to pre-eclamptic mothers had lower MDI~     scores at 24 months of age (P= 0.04) as compared to infants without maternal pre-eclampsia.~     The study by Szymonowicz et al showed that neonates born to pre-eclamptic mothers had a~     significantly lower mean mental developmental index, and significantly more of these~     children had one or more impairments compared with the control group at 2 years of age. The~     neurodevelopmental outcomes in neonates born to preeclamptic mothers therefore remain~     inconclusive. Recently the role of neurobehaviour being evaluated early at 37-40 weeks of~     CGA is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental~     assessment. This assumes significance in the context of initiation of early stimulation and~     objectivised individual developmental rehabilitation regimens for these infants.~   "
46910|NCT02443246|"~     To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with~     that of placebo in adults with Vitamin D Deficiency.~   "
46911|NCT02443233|"~     Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis.~     There are still a lot of uncertainties on how infants acquired HBV leading to the~     development of chronic HBV infection despite active and passive immunoprophylaxis. The~     investigators would like to carry out a prospective study to answer the following questions:~        1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure~        2. the prevalence of immunoprophylaxis failure in Hong Kong~   "
46912|NCT02443220|"~     A prospective, single-center, double-blinded, randomized, controlled clinical study to~     evaluate the antalgic effects between regional or distant combination of acupoints~     stimulated with electroacupuncture on patients undergoing Off-Pump Coronary-Artery Bypass~     Grafting(OP-CABG).This clinical trial is to investigate whether electroacupuncture(EA)~     anesthesia can reduce analgesic in OP-CABG surgery in distant group.The origins of~     therapeutic acupuncture can be traced back at least 2,500 years in China. There has been an~     explosion of interest in Western medicine within the United States and Europe in application~     of acupuncture technique. Acupuncture enjoys worldwide acceptance for treating diseases such~     as migraine, chronic low back pain, and knee osteoarthritis. In 2002, WHO recommended 107~     symptoms, syndromes, and diseases definitively shown to be effectively treated by~     acupuncture. Coronary heart disease (angina pectoris) is among these pathologies. A recent~     clinical trial demonstrated an acupuncture-assisted anesthesia strategy reduces~     postoperative morbidity and medical costs in open-heart surgery under cardiopulmonary~     bypass. Previous researches in animal models have demonstrated that electroacupuncture~     pretreatment protects the heart from ischemic injury. The investigators observed that~     electroacupuncture pretreatment (EAP, 30-minute electric stimulation through 4 electrodes~     attached to the bilateral forearm acupoints) before surgery significantly attenuated serum~     troponin levels during and shortly post-surgery in adult heart valve replacement patients~     and children undergoing cardiac surgery correcting congenital heart malformation.However,~     whether electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in~     different combination of acupoints,has never been previously investigated.~   "
46913|NCT02443207|"~     The aim of the present study was to evaluate the perceived impact of dental caries and~     dental pain on oral health-related quality of life (OHRQoL) among preschool children and~     their families. A cross-sectional study was conduct with 843 preschool children in Campina~     Grande, Brazil. Parents/caregivers answered a questionnaire on socio-demographic~     information, their child's general/oral health and history of dental pain. The Brazilian~     version of the Early Childhood Oral Health Impact Scale was administered to determine the~     perceived impact of caries and dental pain on OHRQoL. Children have undergone an oral~     examination. Logistic regression for complex sample was used to determine associations~     between the dependent and independent variables (OR: odds ratio; α = 5%).~   "
46914|NCT02443194|"~     Primary tumor glioblastoma is the most common malignant brain. Standard treatment includes~     biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass~     reduction. After the surgery patients are treated with radiation and Temodal. The most~     common psychiatric symptom in this patient population is depression, valued at up to~     approximately 50% in patients with glioma . Depression not only adversely affects the~     quality of life of patients but also impairs the ability and cognitive function due to the~     complex clinical course of patients with glioblastoma. There is a tendency to give Diagnosis~     of depression in this patient population, due to a lack of awareness, knowledge and~     literature on the subject. This study was designed to prospectively randomized, controlled,~     double-blind study.~      This method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly~     diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation~     about the study and sign a consent form will enter research.~   "
46915|NCT02443181|"~     This study evaluates the effectiveness of tremor control using various strategies for~     implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor.~     Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated~     using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or~     thalamic electrodes.~   "
46916|NCT02443168|"~     This is a single-center, 2-part, open-label study to evaluate the metabolism and excretion~     and absolute bioavailability of [14C]-AG-221 in healthy male subjects. It is planned for 14~     subjects to be enrolled; each subject will participate in a screening phase, a baseline~     phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be~     collected in Part 1 for analyses. Blood samples will be collected in Part 2. Subjects can~     only participate in either Part 1 or Part 2.~   "
46918|NCT02443142|"~     Traumatic brain injury (TBI) is an important public health problem with an estimated 1.7~     million new cases in the United States each year. Although the vast majority of these~     victims sustain mild TBI, many still develop headache, difficulty concentrating, and~     decreased memory with potential for serious long-term consequences. In particular, mild TBI~     is an important consequence of combat-related injuries sustained by military personnel and~     sports-related injuries in young adults. Unfortunately, treatment of mild TBI is usually~     limited to oral analgesics for headache pain such as acetaminophen (Tylenol) or ibuprofen~     (Motrin or Advil). Since there are no previous randomized trials of these medications for~     mild TBI, their comparative effectiveness is not known. Increasing animal based evidence~     suggests that mild TBI is related to brain cell injury caused by overexpression of a~     cellular enzyme (COX-2) that causes neuroinflammation. Fortunately, inhibition of COX-2 is~     easily achieved using ibuprofen. We hypothesize that head injured patients treated with~     ibuprofen will have a lower incidence of mild TBI symptoms than patients treated with~     acetaminophen. We will conduct a randomized clinical trial to measure the comparative~     effects of ibuprofen versus acetaminophen on the incidence of specific symptoms of mild TBI~     in emergency department patients with head injury.~   "
46919|NCT02443129|"~     The investigators would be interested in applying the enhanced depth imaging technique to~     swept source optical coherence tomography, by modifying the acquisition protocol. Doing so,~     the investigators hope to improve the visualization of the choroid and perhaps even of the~     sclera.~   "
46920|NCT02443116|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282~     in patients with nonalcoholic steatohepatitis.~   "
46921|NCT02443103|"~     This study will explore the biologic activity of guanabenz in reducing bone turn over in~     solid tumor patients with bone metastasis. If successful, this repurposing of an already,~     generic drug could benefit patients faster than manufacturing a novel expensive compound.~   "
46922|NCT02443090|"~     To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and~     sexual side effects.~   "
46923|NCT02443077|"~     This randomized phase III trial studies ibrutinib to see how well it works compared to~     placebo when given before and after stem cell transplant in treating patients with diffuse~     large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not~     respond to treatment (refractory). Before transplant, stem cells are taken from patients and~     stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room~     for healthy cells. After treatment, the stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug~     that may stop the growth of cancer cells by blocking a protein that is needed for cell~     growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem~     cell transplant may help the transplant work better in patients with relapsed or refractory~     diffuse large B-cell lymphoma.~   "
46924|NCT02443064|"~     1. Drug resistance of G+ cocci is a severe healthcare problem. According to the Ministry~          of Health National Antimicrobial Resistant Investigation Net (mohnarin) surveillance~          report, the isolation rate of MRSA is some 60% in China. MRSA infection has become a~          serious clinical problem;~        2. Vancomycin is a bactericidal glycopeptide antibiotic which inhibits bacterial growth by~          hindering the synthesis of cell wall in bacteria. It exerts strong antibiotic effect to~          Gram+ bacteria. It is indicated for serious staphylococcus infections especially MRSA~          infection and has become the gold standard agent in MRSA treatment;~        3. Vancomycin is a time-dependent antibiotic, its clinical and microbiological efficacy is~          related to area under curve（ AUC）/minimum inhibitory concentration （MIC ）(AUIC). Cmin~          at steady state is an surrogate parameter of AUIC, which is closely associated to the~          efficacy;~        4. AUIC >400 and Cmin between 15~20 mg/L are recommended for effective vancomycin~          treatment by Infectious Diseases Society of America （IDSA） although it is still~          disputable;~        5. Due to the absence of PK/PD study on vancomycin in China, administration of vancomycin~          is performed in reference to the recommendation of IDSA. Its suitability to Chinese~          patients is still to be clarified;~        6. Plasma concentrations of vancomycin vary significantly between population and~          individuals. Factors such as large-volume fluid infusion, hypoproteinemia and renal~          clearance, etc. will influence the distribution and excretion of vancomycin, resulting~          in different plasma concentrations between individuals. Results of PK studies differ~          greatly between China and abroad. Administration based on the AUIC or Cmin recommended~          by IDSA would not be suitable to Chinese patients. Given the definite long-term benefit~          of vancomycin treatment, the AUIC or Cmin suitable to Chinese patients must be~          identified by clinical study.~        7. The PK/PD study on vancomycin in the treatment to MRSA septicemia and endocarditis is~          of great significance for more reasonable use and improved therapeutic efficacy of MRSA~          infection.~   "
46925|NCT02443051|"~     This research is designed to determine the effectiveness of attention bias modification for~     socially anxious children and adolescents. Over the course of 3 years, 50 youth will be~     enrolled in the trial.~   "
46926|NCT02443038|"~     This is a 2 year pilot/feasibility project to develop an intervention, test research~     methods, and evaluate the effects of yoga on core strength and balance of an older rural~     population in an effort to ultimately reduce the frequency of falls. The investigators' goal~     for this project is for community and academic partners to develop a yoga program that is~     feasible, safe, and acceptable to an older adult population, then test the program, research~     methods and evaluation, in preparation for conducting a larger randomized trial of the~     intervention.~   "
46927|NCT02443025|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either~     receive a series of two presentations or wait listed to receive them later in the school~     year.~   "
46928|NCT02443012|"~     Diabetic macular edema (DME) is a major cause of visual loss in patients with diabetes~     mellitus. The standard treatment is with focal/grid laser therapy. Topical nepafenac was~     used as an adjunct therapy for treatment of DME.~      The aim of this study is to compare the difference of best corrected visual acuity (BCVA)~     and central macular thickness (CMT) at 3 months post treatment between combination therapy~     of laser and topical nepafenac and laser monotherapy in patients with DME.~   "
46929|NCT02442999|"~     Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for~     fertility treatment to evaluate the impact of screening for obstructive sleep apnea.~   "
46961|NCT02442349|"~     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in~     Asia Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose~     Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth~     Factor Receptor Gene~   "
46962|NCT02442336|"~     The overall goal is to develop and examine the acceptability of a web-based (Internet)~     intervention program for patients with head and neck cancer who have recently completed~     radiation therapy.~   "
46930|NCT02442986|"~     Systemic inflammation and sepsis cause multi organ failure including severe neurologic~     impairment in the course of disease. Neurologic failure typically presents as~     critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is~     associated with an increased mortality rate.~      Clinical parameters to determine the neurologic entities during the course of sepsis are~     heterogeneous. Further research for an association of clinical parameters and the patients'~     outcome is needed.~      The study aims toward differences in the clinical and neurological outcome of surgical and~     non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the~     study is to identify clinical and diagnostic outcome predictors in septic patients.~   "
46931|NCT02442973|"~     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are~     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This~     device uses sound waves to create pictures of the spine in three dimensions. This may allow~     the physician to view the spine in more detail for procedures such as spinal anesthesia and~     other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management~     of labor pain. The precise placement of a needle or catheter in proximity to landmarks of~     the spinal bone anatomy is required for the procedure to succeed. The current standard of~     care is called the 'blind approach' (i.e. without medical imaging) and involves a physician~     manually palpating a patient's back to locate spinal bone landmarks. The needle is then~     inserted with respect to the location of the landmarks and inserted until a~     loss-of-resistance is manually detected. This approach, while most common, has been~     associated with success rates as low as 68% in obese patients (2).~      Alternative methods have been investigated for this problem, including ultrasound (US)~     guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's~     efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image~     soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US~     images are often degraded by a number of noise sources including speckle noise,~     reverberations and off-axis scattering, particularly when bone is present, making~     visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound~     for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided~     spinal anesthesia and diagnostic procedures using standard ultrasound systems is limited and~     the benefits that it offers are heavily dependent on the user's familiarity and skill with~     ultrasonography (4).~      Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to~     address the significant clinical need for technological advances that improve the placement~     of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a~     pocket-sized and battery operated ultrasound instrument that incorporates new signal~     processing-based technologies for enhanced bone imaging including 3D navigation of the~     lumbar spine. The device is a single self-contained unit consisting of an ultrasound system,~     ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™~     technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the~     lumbar spine anatomy.~      SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans~     by automating spinal bone landmark detection and depth measurements and providing a~     real-time assessment of scan plane orientation in 3D. SpineView3D™ makes image~     interpretation and measurements of the lumbar spine anatomy simple, quick, and easy.~     Real-time 2D scans from either SpineView3D™ or general-purpose bone presets are formed using~     patent-pending BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of~     bone anatomy at greater bone-to-tissue contrast compared with conventional ultrasound image~     reconstructions.~   "
46932|NCT02442960|"~     This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given~     orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of~     two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study~     duration will be 12 weeks.~   "
46933|NCT02442947|"~     Using protective or combat garments under heavy heat stress conditions, during rest or~     exertion, may hinder the body`s ability to effectively exchange heat with the environment~     and thereby can lead to heat injuries. The purpose of this research is to physiologically~     examine the new textile solutions that are planned to be integrated in the protective~     garments, combat garments and work uniforms in the army, by evaluating the physiological~     stress obtained during exertion under hot climatic conditions.~   "
46934|NCT02442934|"~     Since critically ill patients are exposed to stressful conditions, the investigators~     evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in~     the Intensive Care Unit (ICU) .~   "
46935|NCT02442921|"~     Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or~     placebo, for 18 months. A follow up will be performed after 12 additional months. The~     primary outcome will be a significant reduction or stabilization of proteinuria during the~     18 month treatment period.~   "
46936|NCT02442908|"~     SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary~     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main~     objective is to study the safety and tolerability of Nutrifriend Cachexia.~   "
46937|NCT02442895|"~     Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of~     347 cycles performed with three different protocols.~   "
46938|NCT02442882|"~     Prior research has investigated the effect of repetitive head trauma as it relates to~     physiological and psychological function. Boxing is one particular sport which predisposes~     athletes to a large amount of head impacts. We plan to assess the effects of a boxing~     tournament on balance, neuropsychological, and visual functions.~   "
46939|NCT02442869|"~     This pilot study will test the feasibility of utilizing an adaptive intervention strategy~     for college students who are suicidal when first seeking treatment at a campus clinic. Right~     now, the typical strategy may rely on a one size fits all approach, but in fact suicidal~     students vary greatly on what and how much they need. This study would allow clinical~     decision making (trying one approach, and if that doesn't work, another) to be empirically~     developed and tested while maximizing resources in overburdened college counseling centers.~     If the aims of this project are achieved, this study could significantly impact service~     delivery to suicidal college students at college counseling centers.~   "
46940|NCT02442856|"~     The overall objective of this study is to evaluate the use of diffuse correlation~     spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with~     vascular risk factors. Optical cerebral blood flow measurements will be correlated with~     changes in arterial blood pressure to assess how CBF is maintained in response to changes in~     ABP, and will be compared to transcranial doppler reference measurements.~   "
46941|NCT02442843|"~     This study is designed to identify changes in the brain that underlie symptoms of~     combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild~     electrical stimulation to the side of the head (using a method called tDCS) in an attempt to~     reduce the symptoms of PTSD.~   "
46942|NCT02442830|"~     The objectives of this study are to test whether there are statistically significant~     differences between the standard of care workup workup of non-hematemesis gastrointestinal~     bleeding by endoscopy [upper, lower and other tests], compared with deployment of a video~     capsule as the first test followed by the most appropriate endoscopic procedure based on~     video capsule findings, if needed. The investigators propose to examine differences in time~     to diagnosis, reduction in numbers of procedures, and length of stay between a standard of~     care workup protocol and our proposed protocol of early capsule endoscopy deployment.~   "
46943|NCT02442817|"~     The purpose of the present study is to gather pilot data on the effects of linagliptin on~     the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha)~     in humans, and to demonstrate the feasibility of such a study in patients with psychosis in~     our setting.~   "
46944|NCT02442804|"~     The purpose of this study is to determine whether pomegranate supplements improve cognitive~     functioning following stroke.~   "
46945|NCT02442791|"~     Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1~     analogs in various degenerative neurological diseases, and in hypoxic brain injuries in~     experimental designs. This study is designed as a safety and feasibility study with patients~     randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of~     hospital cardiac arrest.~   "
46946|NCT02442778|"~     Patients with agitation secondary to dementia of the Alzheimer's type. The diagnosis of~     probable Alzheimer's disease (AD) will be based on the '2011 Diagnostic Guidelines for~     Alzheimer's Disease' issued by the National Institute on Aging (NIA)-Alzheimer's Association~     (AA) workgroups.~   "
46947|NCT02442765|"~     Patients with agitation secondary to dementia of the Alzheimer's type. The diagnosis of~     probable Alzheimer's disease (AD) will be based on the '2011 Diagnostic Guidelines for~     Alzheimer's Disease' issued by the National Institute on Aging (NIA)-Alzheimer's Association~     (AA) workgroups.~   "
46948|NCT02442752|"~     The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)~     [after daily administration for 7 days] and safety [after daily administration for 8 weeks]~     of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with~     acid-related diseases.~   "
46949|NCT02442739|"~     The primary purpose of this study is to see if it is safe to give patients with head and~     neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they~     receive radiation, chemotherapy, and/or surgery for their cancer treatment to prevent~     depression and its effects. Researchers would also like to see if giving ketamine at the~     same time as cancer treatment is practical and reasonably acceptable to the patient.~      New onset depression is highly frequent in those with head and neck cancer, and depression~     has many negative consequences for outcomes in those patients. Therefore, investigators~     would also like to see if giving patients ketamine during their routine cancer treatment~     will prevent the onset of depression and its negative effects on cancer treatment outcomes,~     and also help with anxiety, pain, and quality of life. The study will also use a placebo to~     compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it~     will be look the same as ketamine, as a liquid to be taken by mouth.~      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic~     by itself for some diagnostic and surgical procedures or combined with other general~     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered~     experimental in this study because it is not approved by the FDA for the prevention of~     depression.~   "
46950|NCT02442726|"~     The aim of this study is to measure reaction times and thermal detection thresholds to CO2~     laser stimulation of the skin, before and after a first degree thermal injury, in the~     primary and secondary hyperalgesia area, in order to investigate whether different~     nerve-fiber classes are activated in the post-injury phase. The study results are expected~     to uncover existence of a peripheral inflammatory input contributing to secondary~     hyperalgesia.~   "
46951|NCT02442713|"~     Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings:~     (1) impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye~     movement (REM) sleep. The first two patterns are common in other psychiatric disorders,~     while the REM pattern is very characteristic in depression, so the phase-advance theory was~     accepted by most of psychiatrists. Many researchers have focused on the biological rhythm to~     investigate the etiological and pathophysiology of depression, and they think depression can~     be cured if its sleep abnormality is ameliorated.~      It is well known that most of antidepressants treat depression through 5-hydroxytryptamine~     (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep~     microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can~     ameliorate the sleep architecture abnormality in depression by producing rapid suppression~     of REM sleep.~      Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for~     serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly~     increase the extracellular serotonin level by inhibiting serotonin transport in the~     presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example,~     it was reported by accumulating researches that the serum melatonin level increased markedly~     after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one~     possibility is increased melatonin synthesis, caused by effects on serotonin, which is a~     melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of~     melatonin in the liver.~      Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the~     circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by~     improving the sleep quality and quantity. By now, the changes of sleep architecture in~     fluvoxamine treatment were assessed by only three clinical trials, and their results were~     contradictive. This discrepancy might be due to the small sample size and different study~     design, such as clinical trial duration. Moreover, two of three researches applied~     home-based PSG assessment, which might have distorted the results of sleep architecture to~     some extent. Thus, the effects of fluvoxamine on sleep architecture need to be clarified by~     more clinical trials with standard PSG assessment.~   "
46952|NCT02442700|"~     Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in~     HIV-infected patients who are on antiretroviral therapy especially protease inhibitors~     including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser~     drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non~     HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover~     study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected~     patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to~     receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and~     then were given the other treatment for an additional 12 weeks. Patients were observed for~     lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein~     (LDL) and high density lipoprotein (HDL); and the side effects including clinical and~     laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and~     creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of~     the study.~   "
46953|NCT02442687|"~     To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice~     daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to~     placebo in patients with biopsy-proven nonalcoholic steatohepatitis~   "
46954|NCT02442440|"~     Anisodamine has been widely used in China for its pharmacological effect on improving~     microcirculation during shock. It has been reported that anisodamine is effective in~     reducing mortality rate in children with meningitis. however, its effectiveness in patients~     with septic shock has not been systematically investigated. The aim of the study is to~     investigate the effectiveness of anisodamine in the treatment of patients with septic shock.~   "
46955|NCT02442427|"~     There is a growing body of literature suggesting that monoclonal antibody could be~     efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically~     insignificant adverse effects.~      The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed~     infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions~     to infirmary/observation or hospital for relapse during 3 weeks of follow-up after~     discharge.~   "
46956|NCT02442414|"~     The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single~     agent when given orally to adult patients with advanced solid tumors that have progressed~     despite standard therapy, or where there is no standard therapy.~   "
46957|NCT02442401|"~     The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma~     formation after harvesting LD flap.~   "
46958|NCT02442388|"~     The purpose of this prospective, randomized, double-blind study was to compare the~     prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical~     lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One~     files.~   "
46959|NCT02442375|"~     The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective~     radiation dose and introduction of an intermediate dose-level in the treatment of head and~     neck cancer will results in less radiation sequelae and improved quality of life after~     treatment whilst the recurrence rate in electively irradiated lymph nodes should not be~     compromised.~   "
46960|NCT02442362|"~     This study was designed to compare the efficacy and safety of~     aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for~     metastatic gastric cancer (GC) patients.~   "
46963|NCT02442323|"~     Despite evidence regarding the benefits of physical activity in various cancer patient~     populations, the effects of a home-based walking program for pancreatic cancer patients have~     been under-explored. The aims of the proposed pilot project are to: (1) Assess the~     feasibility of implementing a 12-week, home-based walking program among pancreatic cancer~     patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of~     life (QOL) and symptoms among pancreatic cancer patients.~   "
46964|NCT02442310|"~     The purpose of this study is to look at the pharmacokinetics of a new formulation of~     deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.~   "
46965|NCT02442297|"~     This study is for patients that have a type of brain cancer called Glioblastoma (GBM). The~     body has different ways of fighting infection and disease. No single way seems perfect for~     fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting immune cells present in the blood that can kill other cells, including~     cells infected with viruses and tumor cells. Both antibodies and T cells have been used to~     treat patients with cancers. They have shown promise, but have not been strong enough to~     cure most patients.~      The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor~     2). This antibody sticks to GBM cells because of a substance on the outside of these cells~     called HER2. Up to 80% of GBMs are positive for HER2 . HER2 antibodies have been used to~     treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed~     so that instead of floating free in the blood it is now attached to T cells. When an~     antibody is joined to a T cell in this way it is called a chimeric antigen receptor (CAR).~     These CAR-T cells seem to be able to kill tumors like the one these patients have, but they~     don't last very long and so their chances of fighting the cancer are limited. Therefore,~     developing ways to prolong the life of these T cells should help them fight cancer.~      These HER2-CAR T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the largest safe dose of HER2-CAR T cells, to learn~     what the side effects are, and to see whether this experimental intervention might help~     patients with GBM who volunteer to test this new agent.~   "
46966|NCT02442284|"~     This is a study to evaluate the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and~     Dasabuvir with or without Ribavirin in US veterans with genotype 1 chronic hepatitis C virus~     infection.~   "
46967|NCT02442271|"~     This is a Phase 3b, open-label, multicenter study to evaluate the proportion of subjects~     achieving sustained virologic response 12 weeks post-treatment (SVR12), in adults with~     genotype 1 (GT1) chronic HCV infection, who received treatment with~     ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.~   "
46968|NCT02442258|"~     This is an open-label, single dose study designed to assess the pharmacokinetics and safety~     of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal~     function.~   "
46969|NCT02442245|"~     Part one of this study will consist of baseline (BL) testing, 28 days of daily~     supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists~     of five visits, of which, the first visit will consist of maximal strength testing. The~     remaining visits will consist of performance testing and muscle evaluation.~      Phase two of this study will consist of six weeks of supervised resistance training along~     with supplementation of XSurge. Following the six weeks of training, subjects will complete~     a second acute exercise protocol. Measures to be evaluated will consist of performance~     testing and muscle evaluation.~   "
46970|NCT02442232|"~     The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to~     propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3~     and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms~     on biomarkers related to nitric oxide after propofol anesthesia. In addition, the~     investigators will evaluate the effects of propofol anesthesia on biomarkers related to~     nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme~     inhibitors.~   "
46971|NCT02442219|"~     Persons with coeliac disease treated with a gluten free diet will be asked to give blood for~     a new diagnostic blood test. In this test investigators will use multimerized HLA bound to~     different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along~     with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that~     these cells will be present in persons with coeliac disease regardless of gluten-intake.~     Investigators will compare their findings with two control groups; Persons on a gluten free~     diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten~     containing diet (healthy control group). In the initial and main study investigators will~     look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.~   "
46972|NCT02442206|"~     This mechanistic study is a single-center, randomized, double-blind, placebo-controlled,~     cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and~     lung function parameters in hyperinflated COPD patients.~   "
46973|NCT02442193|"~     The overall aim of the study is to assess the feasibility of conducting a Randomized~     Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support~     (IPS) in improving employment rates and associated psychosocial outcomes in forensic~     psychiatric populations.~   "
46974|NCT02442180|"~     Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However,~     null- or partial responder of steroid treatment is recommended to consider liver~     transplantation. The yearly demand for liver transplants far exceeds the supply of available~     organs and alcoholic liver disease has been a controversial indication for transplantation.~     Granulocyte-Colony Stimulating Factor (G-CSF) has been reported to have effect of~     proliferation of hepatic progenitors in alcoholic steatohepatitis. The aim of this study is~     to investigate the efficacy of G-CSF in patients with severe alcoholic hepatitis with null~     or partial response to steroid.~   "
46975|NCT02442167|"~     Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of~     cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of~     FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators~     conducted a prospective study in 2 university hospitals to determine diagnostic performance~     of FISH for the diagnosis of malignant biliary strictures in Thai patients.~   "
47020|NCT02441569|"~     This trial examines the effectiveness of training pediatric primary care providers (nurse~     practitioners, doctors) to use of strategies that enhance family/youth empowerment and~     engagement during office visits for children with mild to moderate problems with anxiety.~     Children coming for routine care at one clinic are screened for anxiety symptoms and seen by~     either a specially trained provider or one of the clinic's other regular staff members.~   "
47021|NCT02441556|"~     This trial will provide valuable insights into the safety and efficacy of endovascular~     treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of~     estimated occlusion time.~   "
46976|NCT02442154|"~     Severe head injury is associated with airway compromise and poor respiratory effort. In~     Mulago Hospital intubation is the mainstay intervention and then patients are subjected to~     the wait and see strategy of delayed or no tracheostomy, very few undergo early~     tracheostomy, and some patients are left without an artificial airway.Using endotracheal~     tubes is associated with complications which have been shown to increase intensive care unit~     (ICU) and hospital stay, morbidity and mortality.~      Tracheostomy has been reported to have advantages over translaryngeal intubation but the~     optimal timing of tracheostomy in patients with severe head injury is controversial. Studies~     done elsewhere have showed that patients with severe head injury who undergo early~     tracheostomy have better survival outcomes but no studies have been done in our setting~   "
46977|NCT02442141|"~     The purpose of this research study is to examine the effects of routine anesthesia on infant~     brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the~     brain of infants during surgery. This study will help the investigators detect possible~     blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors~     (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood~     will be used. Sensors will rest on the child's skin and record measurements before, during~     and after the surgery.~   "
46978|NCT02442128|"~     Several methods have been proposed to improve intubating conditions and minimize sevoflurane~     induction time during sevoflurane induction in children. These include clonidine~     premedication, [5] addition of nitrous oxide, [6] opioids, [7,8] or propofol [9].~      Four Studies evaluated sevoflurane alone for intubation (9-12).Aim of this study: is to~     evaluate the effects of two different dose of propofol preceded by a fixed dose of fentanyl~     during sevoflurane induction on quality of tracheal intubation in children undergoing~     elective surgery.~   "
46979|NCT02442115|"~     The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and~     mental health disruptions that occur with the three core behavioral criteria used for~     diagnosis (social behavior, communication, restricted interests/repetitive behavior).~     Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are~     overlooked when designing research strategies to understand the mechanisms underlying the~     expression of ASD. This study was initially a collaboration between Children's Hospital Los~     Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research~     project proposes to recruit subject at CHLA and the Center for Autism and Developmental~     Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine~     (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in~     pediatric populations with ASD. Over a 12 month period, subjects will receive standard of~     care for their GID, typically functional constipation. The study population will be~     characterized with a standardized instrument for diagnosing functional GI disorders in~     children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical~     acumen of an experienced pediatric gastroenterologist. Nutritional information also will be~     collected to determine whether there are patterns of GIDs that correlate with dietary and~     nutritional status. The in-depth characterization and treatment of GIDs in children with ASD~     will provide a unique way of determining if ASD symptom and GID symptom improvement are~     related to each other. In Aim 2, the investigators will do in-depth assessment of each~     subjects functional status for social communication, emotional regulation, cognitive~     function, speech-language, sensory integration, and a biomarker of oxidative stress. The~     latter will be measured in urine samples over the course of one year. There are no direct~     interventions for autism symptoms in this study. Rather, subjects will receive standard of~     care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our~     power calculation shows that the investigators will be adequately powered with the proposed~     study design and recruitment targets. As part of the study, the investigators have developed~     a collaboration with investigators in the University of Southern California (USC) School of~     Engineering, in which the investigators will work with them to develop computational tools~     to assist in the characterization of videotaped Autism Diagnostic Observation Schedule~     (ADOS-2) assessments.~   "
46980|NCT02442102|"~     An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal~     intubation may improve patient outcomes. The investigators propose treatment sessions~     targeting sensorimotor integration, strength, and range of motion during oral endotracheal~     intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food~     or liquids entering the airway), establish a solid foundation in understanding reasons for~     swallowing impairment after extubation from mechanical ventilation and learn new methods to~     reduce or prevent these problems.~   "
46981|NCT02442089|"~     Missed health care appointments present a serious challenge to patient care. Especially in~     government funded health systems like that of Chile, missed appointments can lead to delayed~     care, wasted resources, and escalating costs.~      This private-public-research collaboration seeks to provide a rigorous, practical evaluation~     of a new patient reminder system, evaluate how health beliefs impact patient attendance, and~     capture the potential for scaling up this or other health technology systems. Using a~     mixed-methods approach this study will provide contextualized, triangulated analysis of~     pediatric patient attendance in Chile.~   "
46982|NCT02442076|"~     Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional~     Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by~     Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its~     correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles~     varies from area to area, are not yet clarified.In this study, the abovementioned issues~     will be investigated experimentally through non-invasive method.~      About 10 healthy volunteers, aged 20~65, will be recruited. The investigators will measure~     the needle and the skin tremor by video optical microscopy. The variation of skin tremor and~     needle vibration and their spectra will be analyzed digitally. The model correlating skin~     tremor, needle vibration and basic physiological parameters will be constructed.The fact~     that the skin tremor and the needle vibration come from the same origin is expected.~      However; due to the leverage effects and different dynamical responses to the source~     vibrations at different frequencies, needle vibration might exhibit some difference from~     skin vibration in their power spectra. This study should be able to construct a clear model~     of the possible vibration sources such as heartbeat and breathing, the area dependence of~     vibrations, the correlation between the skin and the needle vibrations, and the correlation~     with other physiological parameters.~   "
46983|NCT02442063|"~     This phase Ib combination study is being conducted to assess the safety and tolerability of~     radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions~     with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration~     of the mode of interaction (i.e. additive or synergistic interaction) between the selected~     chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.~   "
47022|NCT02441543|"~     Preclinical studies and clinical observations have shown the Phosphoinositide 3-kinase~     (PI3K) /Protein kinase B (AKT) /mammalian (mechanistic) target of Rapamycin (known as the~     'mTOR-pathway') signaling to be deregulated in several tumors.~   "
46984|NCT02442050|"~     The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would~     allow for prolonged re-dosing intervals while providing equivalent myocardial protection.~     The use of del Nido solution has been used extensively in congenital heart surgery for over~     25 years. The primary objective is to determine whether expanding this technique to adult~     cardiac surgery will confer significant benefits in both surgical workflow and patient~     clinical outcome. The investigators hypotheses with regard to the del Nido solution will~     demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in~     functional recovery or clinical outcome, and (2) superior delivery to the current~     blood-based cardioplegia strategy in cost analyses.~   "
46985|NCT02442037|"~     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem~     cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind,~     controlled prospective study.~   "
46986|NCT02442024|"~     The investigators aimed at evaluating the metabolic effects of the inversion of the typical~     Italian sequence of food ingestion at the main meals in type 2 diabetic patients.~   "
46987|NCT02442011|"~     This is a bio repository of blood specimens from subjects with different Hematological~     disorders.~   "
46988|NCT02441998|"~     Colorectal cancer is the second leading cause of cancer related death in the United States.~     Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm)~     are the most commonly found polyps during colonoscopy. Although these polyps have a very low~     risk of harboring malignancy, they are routinely removed to determine surveillance~     intervals.~      Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can~     allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice~     can be applied widely, there is significant potential for cost savings.~      This has led to a 'characterize, resect and discard' strategy where polyps determined to be~     hyperplastic (benign with no neoplastic potential) can be left in place and those determined~     to be adenomatous (have neoplastic potential) can be resected and discarded.~      It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can~     achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide~     practice.~   "
46989|NCT02441985|"~     Primary orthostatic tremor(POT) is a rare progressive functionally disabling tremor~     disorder. The characteristic features of POT are symptoms of unsteadiness in legs reported~     by patients when they are standing and improvement of symptoms upon walking and sitting. Due~     to the limited success of other treatment options there is a clear merit in continuing~     efforts to explore and investigate novel treatment modalities. Transcranial magnetic~     stimulation (TMS) is a well-established physiological tool to understand brain function.~     When repetitious TMS pulses are delivered to a specific target at predefined stimulation~     parameters, it is referred to as rTMS therapy.The investigators propose a novel approach to~     investigate the clinical and physiological effects of low frequency rTMS therapy in POT. The~     overarching hypothesis of this study is that low frequency rTMS therapy delivered to the~     cerebellum will modulate the cerebellar excitability and result in clinical improvements.In~     order to determine the physiological effects related to rTMS, the tremor physiology will~     also be recorded with surface electromyography (EMG). The investigator will also record the~     changes in cerebellum excitability in response to rTMS using cerebello-cortical inhibition~     (CBI), a well-established TMS parameter.~   "
46990|NCT02441972|"~     The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective~     for cancer diagnosis and therapy response.~   "
46991|NCT02441959|"~     The purpose of this study is to compare the clinical and radiographic outcomes of full~     endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar~     herniated discs in which the patient's leg pain is greater than back pain.~   "
46992|NCT02441946|"~     The purpose of this study is to evaluate the biological effects of abemaciclib in~     combination with anastrozole and compare those to the effects of abemaciclib alone and~     anastrozole alone in the tumors of postmenopausal women with hormone receptor positive~     (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.~   "
46993|NCT02441933|"~     This is a randomized, open-label, multicenter, phase III study comparing anthracyclines~     followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant~     therapy in patients with triple-negative breast cancer.~      Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who~     need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant~     chemotherapy for TNBC are eligible.~   "
46994|NCT02441920|"~     Periodontitis is a highly prevalent chronic inflammatory disease that is characterized by~     loss of the periodontal ligament and alveolar bone, and is a major cause of tooth loss.~     Results from clinical and epidemiological studies have suggested that periodontitis and~     tooth loss are more prevalent in individuals with rheumatoid arthritis (RA). There is~     evidence to suggest that periodontitis could indeed be a causal factor in the initiation and~     maintenance of the autoimmune inflammatory response that occurs in RA. If so, chronic~     periodontitis might represent an important modifiable risk factor for RA. However, to date~     longitudinal studies on the effect of periodontitis on disease progression in RA are~     lacking. The aim of the present study is to assess the periodontal status of patients~     enrolled in an established longitudinal cohort of RA patients. These data will then be~     analysed to evaluate whether or not periodontal inflammation is related to parameters of~     rheumatoid arthritis.~   "
46995|NCT02441907|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This~     condition can develop in diabetics where swelling results from leaking of fluid from the~     blood vessels of the eye, into the center of the retina, the macula. If left untreated, this~     can affect central vision. The current standard treatment for diabetic macular edema~     includes medications injected directly into the eye (intravitreal injections) and laser eye~     treatment. The drugs that are injected directly into the eye are known as anti-Vascular~     Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. However,~     response in patients to these anti-VEGF drugs can vary and examination of predictive factors~     is required. This particular study examines cellular factors called cytokines in patients~     receiving aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in~     cytokines that can predict treatment response amongst groups of patients.~   "
46996|NCT02441894|"~     Primary Objective:~      To assess the tolerability of cabazitaxel 25 mg per body surface area (m^2) with primary~     prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms~     of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count [ANC]~     <1000 per volume [mm^3] and a single temperature of >38.3 degree or a sustained temperature~     of ≥38 degree Celsius for more than one hour) during Cycle 1.~      Secondary Objective:~      To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose~     delay due to adverse events (AEs); dose reduction due to AEs; relative dose intensity;~     incidences of FN-related hospitalization and use of intravenous (IV) anti-infectives;~     tolerability according to National Cancer Institute Common Terminology Criteria for Adverse~     Events (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor~     response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if~     available.~   "
46997|NCT02441881|"~     A double blind randomised controlled trial of radiofrequency thermal ablation treatments of~     great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal~     Therapy vs. Endovenous Radiofrequency.~      Assessments by visual pain scores, duplex ablation and quality of life questionaires~   "
46998|NCT02441868|"~     This study is a pilot test of an intervention to train family caregivers of home hospice~     patients about recognizing and treating shortness of breath.~   "
46999|NCT02441855|"~     Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the~     leading cause of death. Prognostic scores have been developed to estimate the risk of~     adverse outcome. Several serum biomarkers have been also investigated in patients with CAP.~     A growing number of echocardiographic markers have been evaluated as possible predictors of~     prognosis in patients with pulmonary and infectious diseases such as sepsis, septic shock,~     human immunodeficiency virus infection, pulmonary tuberculosis, and chronic obstructive~     pulmonary disease. As echocardiography is a non-invasive, reliable, cost-effective, and~     reproducible diagnostic tool to evaluate cardiac function and structures, the investigators~     aimed to investigate left and right ventricular functions and aortic elastic properties in~     CAP patients. Furthermore, the investigators also aimed to observe relationships between~     echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with~     CAP.~   "
47000|NCT02441842|"~     Perioperative hypertension is commonly associated with surgical craniotomy. As the~     sympathetic nervous system and the renin-angiotensin-aldosterone system play a key role in~     the development of this hypertension, preoperative single dose therapy with a -adrenergic~     receptor blocker or an angiotensin converting enzyme (ACE) inhibitor may be useful in~     preventing this. To assess this as well as to study potential markers of these two systems,~     the investigators will perform a randomized, double blind, placebo controlled study to~     compare the single dose effect of preoperative administration of a -receptor blocking drug~     (atenolol) and an ACE inhibitor (lisinopril) with a control group receiving a placebo tablet~     (glucose) on perioperative hypertension in craniotomy patients.~   "
47001|NCT02441829|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single~     oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and~     impaired renal function. Participants in the healthy control group will be matched to~     participants with impaired renal function by age (± 5 years), gender, and body mass index (±~     10%).~   "
47002|NCT02441816|"~     The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is~     to achieve and maintain the best benefit of visual function and avoid unnecessary hospital~     visits.~      The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of~     treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to~     improved vision and reading speed in eyes with active wet AMD over 2 years while reducing~     hospital visits.~   "
47003|NCT02441803|"~     Objectives:~      Primary Objectives:~        1. To determine the safety and feasibility of allogeneic hematopoietic stem cell~          transplantation (AHSCT) as initial salvage treatment for patients with primary~          induction failure (PIF) acute myeloid leukemia (AML).~        2. To determine efficacy of AHSCT following decitabine, clofarabine, idarubicin, and~          cytarabine (DCIA) salvage chemotherapy evaluated by overall response rate (RR), defined~          as complete response (CR) or CR without platelet recovery (CRp) or CR with insufficient~          hematological recovery (CRi).~      Secondary Objectives:~        1. To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2~          courses of induction chemotherapy.~        2. To determine the early treatment-related mortality (TRM) (within first 4 weeks of first~          salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT.~        3. To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF~          AML (% of patients who achieve </=5% bone marrow blasts prior to AHSCT.~        4. To determine the TRM at 1 year, relapse rate (RR), overall survival (OS) and event-free~          survival (EFS) for patients with PIF AML treated with DCIA followed by early AHSCT.~   "
47004|NCT02441790|"~     Fractures of the fifth metacarpal neck are the most common injury involving the upper~     extremity. Patients are typically young adult males. Restoring function quickly and reliably~     for return to work and/or activity is important; these patients are a significant labour~     force demographic. Treatment is historically splinting for approximately 3-4 weeks.~     Splinting a fracture is a trade-off. Immobilization allows stabilization and fracture~     healing, but also causes hand stiffness and weakness leading to impaired function. Little~     prospective research exists; there is no agreement for ideal duration of splinting or~     therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is early~     active range of motion (EAROM). The objective of this trial is to establish if EAROM~     provides improved early (6 week) hand function when compared to standard immobilization.~   "
47005|NCT02441777|"~     The aim of this pilot study is to assess the ability of a new polarization sensitive optical~     coherence tomography system to obtain high-quality images of retinal birefringence.~   "
47006|NCT02441764|"~     This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.~   "
47007|NCT02441751|"~     QT interval changes is measured during all phases of the operation. The protocol is focusing~     at intraoperative bleeding events and is also observing QT interval changes during~     anesthetic and operative procedures.~   "
47008|NCT02441738|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of~     developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains~     the most feared complication of AF with an increase in risk by 5-fold.~      Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to~     the advanced electrical and structural remodeling the single procedural results of catheter~     ablation for persistent and longstanding persistent AF are rather disappointing without a~     proven superiority of any applied strategy compared to others. However, repeated catheter~     ablation can achieve better results. The surgical (epicardial) approach seems to be more~     effective, though still a significant amount of failures exist. Checking the epicardial~     ablation lines and if necessary making additional endocardial lines (which is a hybrid~     ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most~     complete lesion set.~      The study objective of this pilot trial is to compare the safety and efficacy of repeated~     catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic~     epicardial surgery combined with endocardial catheter ablation (performed one-stage) in~     preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory~     patients with persistent or longstanding persistent atrial fibrillation.~   "
47009|NCT02441725|"~     This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a~     measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD).~     Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and~     questionnaires.~   "
47010|NCT02441712|"~     This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of~     patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP~     can have a variety of impairments, such as knee and hip muscle weakness, poor movement~     patterns, weak core activation and muscle tightness. Several recent RCT trials have looked~     at treating single impairments, but to date no RCT have address individualized patient~     impairments during a rehabilitation program. Abnormal muscle firing patterns have also been~     identified during functional tasks; such as jogging, stair climbing, and performing a single~     leg squat. Conflicting studies have produced changes to the quadriceps and hip muscle firing~     patterns with those with PFP. The abnormal activation patterns has been suggested to be why~     strengthening programs alone do not improve movement patterns during functional tasks for~     those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of~     electrical stimulation that replicates proper firing patterns based off healthy~     electromyography patterns. The purpose of the study is to investigate the benefits of PENS~     with a impairment based rehabilitation program for the treatment of PFP. The rationale for~     this investigation is to assess the benefits of PENS with therapeutic exercise at improving~     altered firing patterns of the lower extremity muscles during functional tasks.~   "
47011|NCT02441699|"~     This is a matched-cohort study designed to assess the health impact of a rural demand-driven~     water and sanitation intervention that provides piped treated water and household level~     pour-flush latrines and bathing rooms, as implemented by Gram Vikas.~   "
47012|NCT02441686|"~     This research study is evaluating a combination of three drugs called lenalidomide,~     subcutaneous (injection under the skin) bortezomib, and dexamethasone (RVD) as a possible~     treatment for multiple myeloma.~   "
47013|NCT02441673|"~     Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded~     based on it's severity and has been known to cause various problems like patient's~     discomfort, hypoxia, change in hemodynamic variables of the patient and poor wound healing.~     This problem has been managed via pharmacologic and non-pharmacologic means.~     Non-pharmacologic modalities involve options aimed at warming the patient.~     Pharmacologically, opioids are used more commonly to prevent and treat this condition. This~     then introduces the side effect of nausea/vomiting and sedation which may reduce overall~     patient's satisfaction on the perception of the Subarachnoid block. It is for this reason~     that Nefopam - a centrally acting non-opioid, non-steroidal anti-inflammatory drug (NSAID)~     analgesic, relatively new drug in the Nigerian market with significant anti-shivering effect~     is compared with a well established opioid like Tramadol. Having similar cost profile, the~     option of replacing Tramadol with Nefopam especially in conditions where the patient is more~     hemodynamically unstable is considered in this project.~   "
47014|NCT02441660|"~     A prospective case control study to determine the effectiveness and longevity of 8%~     capsaicin patch in treating neuropathic pain in persons with spinal cord injury. The~     investigators will study spinal cord injury patients at South Texas Veterans Health Care~     Systems Spinal Cord Injury inpatient unit and outpatient clinics.~   "
47015|NCT02441647|"~     The purpose of this study is to check the safety under normal conditions of use through the~     emergence of signs of irritability and sensitization of the genital mucosa.~   "
47016|NCT02441621|"~     The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV)~     and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of~     left ventricular diastolic dysfunction is still unknown. The aim of the present study was to~     challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing~     aortic valve replacement.~   "
47017|NCT02441608|"~     The purpose of this study is to prove the product tested does not cause photoirritation or~     photosensitization reactions when exposed to sun light.~   "
47018|NCT02441595|"~     The purpose of this study is to explore if an intervention using Mindfulness Based~     Childbirth and Parenting education (MBCP) targeted to stressed pregnant women is effective~     in: 1) reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3)~     preparing the mother for labor and 4) promoting positive infant-caregiver attachment.~   "
47019|NCT02441582|"~     This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to~     reperfusion in patients presenting with STEMI. A randomised controlled trial will be~     conducted in Gauteng and the Western Cape among 100 adult patients (>18 years) presenting~     with ST-elevation myocardial infarction according to a specific inclusion and exclusion~     criteria outlined in the full protocol. Consenting patients will be randomly assigned to~     have their prehospital ECG sent to the receiving cardiac facility or not. The~     onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the~     two groups by using the Fisher's exact test and a simple unpaired Student's t-test. Data~     will also be subjected to multivariate analysis of variance to test for statistical~     significance within a variety of factors that may influence reperfusion times.~   "
47023|NCT02441530|"~     Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial.~     Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients~     were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400~     mg ibuprofen twice a day,2 days before the date of menstruation and continued through the~     first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin~     D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group~     Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of~     vitamin D are more prominent~   "
47024|NCT02441517|"~     The purpose of the study is to understand if there is benefit in treatment with a medicine~     called enzalutamide in the re-treatment setting. Patients must have been previously treated~     with enzalutamide in the pre-chemotherapy setting for a minimum of 8 months and have disease~     progressed, followed by docetaxel and/or cabazitaxel for at least 4 cycles.~   "
47025|NCT02441504|"~     Background: The aim of the present study was to evaluate the changes in the microvascular~     density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity~     chronic exercise training.~      Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease~     duration > six years. We used intravital video-microscopy to measure the basal skin~     capillary density as well as capillary recruitment using post-occlusive reactive hyperemia~     (PORH) in the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of~     the skin microcirculation was evaluated in the forearm with a laser Doppler perfusion~     monitoring (LDPM) system in combination with acetylcholine and sodium nitroprusside~     iontophoresis, PORH and local thermal hyperemia.~   "
47026|NCT02441491|"~     ROHHAD (rapid onset obesity, hypothalamic dysfunction, hypoventilation, and autonomic~     dysregulation) syndrome is a rare pediatric disorder associated with a cancer called~     neuroblastoma and presumed to be driven by an attack of the immune system on specific area~     in the brain. Patients develop severe symptoms and often succumb to this disease. Based on~     the researchers' experience the investigators conduct a clinical trial to study intensive~     immunosuppression with high-dose cyclophosphamide in these patients. In addition to~     describing the symptomatic improvement, the investigators' trial seeks to define objective~     markers of disease activity.~   "
47027|NCT02441478|"~     Epilepsy is a frequent neurological disorder with about a third of patients having seizures~     despite treatment. At least some of these seizures can be linked to a low compliance and~     therapy adherence of patients. Compliance is defined as the extent to which a person's~     behavior (in terms of taking medication, following diets, or executing life style changes)~     coincides with medical or health advice. Therapy adherence of patients suffering from~     epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive~     drug therapy is critical for effective disease management and low therapy adherence is~     associated to higher mortality in epilepsy. The reasons for low therapy adherence are still~     a matter of research. Some known factors influencing compliance in epilepsy are related to~     its chronic nature, but others seem to lie in a complex interaction between psychiatric~     comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy~     adherence rests a variable difficult to measure, especially in epileptic patients where~     classical tools such as questionnaires and electronic monitoring devices have been shown to~     be imprecise. It has been argued that the term 'compliance' should be replaced by~     'co-operative behavior' and non-compliance can therefore be interpreted as troubled~     co-operative behavior. This behavioral approach offers the potential of using tools and~     methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific~     field on the border of psychology, economics and neuroscience, has used economic game~     paradigms in order to operationalize cooperative behavior and to identify several brain~     areas by functional brain imaging that have been linked to social co-operative behavior. The~     majority of these brain areas are located in the frontal cortex [ventromedial~     frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating~     in the frontal lobe are subsumed under the term frontal lobe epilepsy (FLE) and represent~     20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to~     epilepsy surgery.~      The investigator's project plans to study compliance and cooperative behavior of patients~     suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the~     behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-,~     and education-matched healthy controls, (2) correlation of game behavior to brain activation~     measured by functional magnetic resonance imaging in both patients and healthy controls and~     (3) studying the link between cooperative behavior to compliance captured by pill counts and~     questionnaires.~   "
47028|NCT02441465|"~     This study is to characterize the pharmacokinetics (PK) of a single intravenous (IV)~     infusion of ^14 C-labeled vemurafenib administered shortly after an oral dose of vemurafenib~     and following multiple oral doses of vemurafenib twice daily (BID) at steady state as well~     as to estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at~     steady state in participants with BRAF^V600 mutation-positive malignancies.~   "
47029|NCT02441452|"~     The aim of this study was to compare the functional capacity of exercise by six-minute walk~     test and lung function by spirometry, before and after Nuss procedure in subjects who have~     undergone the early rehabiliation program with those who were under conventional care.~     Researchers want to find out if early rehabilitation is a strategy to enhance recovery after~     Nuss procedure.~   "
47030|NCT02441439|"~     This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously -~     200 mg versus 500 mg.~   "
47031|NCT02441426|"~     Malnutrition is considered one of the most prevalent risk factors for morbidity and~     mortality in children under five. An estimated 20% of children in the developing world are~     malnourished [1] and poor nutrition is linked to more than half of all child deaths~     worldwide [2]. Malnutrition in early childhood may lead to cognitive and physical deficits~     and may cause similar deficits in future generations as malnourished mothers give birth to~     low birth weight children [3]. In addition, malnutrition increases susceptibility and~     incidence of infections and is associated with diminished response to vaccines.~      The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that~     alter gut function and impair children's nutrition, growth and development to help develop~     new intervention strategies that can break the vicious enteric infection-malnutrition cycle~     and reduce its global burden.~      The overall objective of the MAL-ED Project is to quantify the associations of specific~     enteric pathogens, measures of physical and mental development, micronutrient malnutrition,~     gut function biomarkers, the gut microbiome, and immune responses in very young children in~     resource-limited settings across eight sites that vary by culture, economics, geography, and~     climate.~      The central hypothesis of the MAL-ED Project is that infection (and co-infection) with~     specific enteropathogens leads to impaired growth and development and to diminished immune~     response to orally administered vaccines by causing intestinal inflammation and/or by~     altering intestinal barrier and absorptive function. Data analyses will test for~     associations between enteropathogen infections and growth/development to help illuminate:~        -  which micro-organisms or mixed infections are most frequently associated with growth~          faltering and poor development; and~        -  at what age specific infections cause the most disruption to growth and development and~          impair immune response.~   "
47032|NCT02441413|"~     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early~     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust~     and automated segmentation algorithms will be developed for these parameters, focusing on~     quantitative computed tomography (CT) image analyses to provide the physician a more~     sensitive diagnostics tool. The evolution of BOS over time will be monitored using~     nmon-rigid image registration methods.~   "
47033|NCT02441400|"~     To provide a research tool enabling physicians to monitor long term clinical outcomes for~     patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES~     Stimulation System.~   "
47034|NCT02441387|"~     Predictors of response to pharmacological treatment of major depressive disorder will be~     investigated. One hundred and twenty patients will be included in a naturalistic clinical~     trial. Psychopathology, personality traits, cognitive performance, brain structural changes~     and genetic polymorphisms will be evaluated. Patients will be followed for 18 months with a~     pharmacological treatment algorithm and will be evaluated monthly until 6th month and every~     3 months, up to 18 months. Psychoeducation will be offered to patients who did not remit~     until 3 months of pharmacological tretment.~   "
47035|NCT02441374|"~     There are some treatments after Stroke. Among these, use forced therapy (FUT), which is~     based on overcoming learned disuse by reintroduction of the paretic upper limb in the~     performance of daily activities. There are different protocols FUT to the daily time~     constraint, the number of days and even the type of constriction. Researchers have developed~     a protocol using four weeks constriction, daily constriction 24 hours and with the free end~     of the weekends. Because it is a restrictive therapy, which requires the use of one of the~     arms and on the other hand, this mode of treatment is open to criticism, however, despite~     the efficacy of the protocol, patients do not have good adhesion to the protocol for the~     constriction severe over time. The objective of this work is to verify the safety of the~     developed protocol and analyze the feasibility of reducing the daily time of constriction 12~     hours, with a new protocol movement constriction, easier to perform and more patient~     acceptance. Participate in this study 82 individuals hemiparetic post Stroke, which will be~     recruited to Neurovascular Diseases Clinic and will be registered at the Rehabilitation~     Center of Integrated State Hospital. Participants will be randomly divided into three~     groups: the FUT24 (non-paretic upper limb constriction 24 hours a day, five days a week for~     4 weeks), the FUT 12 (non-paretic upper limb constriction for 12 hours a day, five days a~     week for 4 weeks) and CK (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will~     be held weekly and after the end of the monthly monitoring reviews protocols. For the rating~     scales are use: National Institute of Health Stroke Scale, the Ashworth Scale, the Wolf~     Motor Function Test, the Motor Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and~     surface electromyography (flexor and extensor muscles wrist). The researchers hope that this~     protocol does not bring damage to the upper limb in constriction and it is established a new~     protocol FUT easier to perform and more acceptable to patients, allowing the use of this~     technique by health professionals.~   "
47036|NCT02441361|"~     Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese~     subjects. This trial aims to test whether exercise training can add to the benefits of~     bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to~     investigate whether exercise training can counteract bone loss induced by bariatric surgery.~   "
47037|NCT02441348|"~     Voice therapy is the standard-of-care for many of the nearly 140 million people in the~     United States who suffer from voice disorders,1 yet patients claim that current therapies~     are ineffective at meeting their voice needs.2 Published data by our research team indicate~     that patients think that transfer of target voice techniques to every day voice use (i.e.~     conversation) is the most difficult aspect of therapy,2 and that training techniques in~     conversation is the most useful aspect of voice therapy.2 Unfortunately, traditional voice~     therapy programs spend little, if any, time training voice techniques in conversation.3 This~     lack of functional specificity in voice therapy may contribute to the estimated 65%~     attrition rate.4 Even after some form of treatment, patients are still struggling with daily~     conversational voice use, and voice disorders continue to cause serious disability, stress~     and depression, which negatively affects social functioning and job performance.5 A new~     voice therapy program, Conversation Training Therapy (CTT), based on published patient~     reports on dissatisfaction with traditional therapy, was developed by the Investigators. It~     was honed with recommendations from expert clinical voice-specialized speech-language~     pathologists, and successfully piloted in a small case series of patients with voice~     problems. The investigators objective in this application is to test CTT in the~     rehabilitation of patients with voice disorders. The investigators hypothesize that, as~     demonstrated in the investigators preliminary case studies, these methods will result in~     early treatment success, and reduce the time required to reach therapeutic goals, thereby~     reducing costs associated with voice treatment.~   "
47038|NCT02441335|"~     The goal of this study is to examine how cellular dysfunction can lead to preterm birth.~     Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture~     of membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries~     (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes~     will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and~     placental biopsy (delivery) will be collected.~   "
47039|NCT02441322|"~     This study is to assess the utility of high resolution 3D echo planar magnetic resonance~     spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM)~     patients.~   "
47040|NCT02441309|"~     This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target~     sample size of 40 patients will be recruited from up to 8 EU countries, but this may be~     revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma~     will be divided into three treatment groups. They will all either have surgery or a biopsy~     before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or~     Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum~     of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36~     weeks of Mifamurtide treatment.~   "
47041|NCT02441296|"~     The optimal choice of carbohydrate in infant formula needs to be assessed in more detail.~     Lactose has conventionally been used in most milk-based infant formulas, but more recently~     lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity.~     However, the metabolic consequences have not been examined.~      In a pilot study, the investigators will assess the postprandial metabolic response to a~     meal of formula with either lactose or maltodextrins. A breastfed reference group is also~     included.~   "
47042|NCT02441283|"~     This is a rollover study to assess resistance and durability of response to ABT-493 and/or~     ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents~     for the treatment of chronic HCV.~   "
47056|NCT02441101|"~     This clinical study has been designed to test whether a new pacing therapy would lead to~     improvement in heart function, symptoms and quality of life in a specific group of heart~     failure patients. This group has a unique electrical conduction problem (Right Bundle Branch~     Block) that did not respond well to the current available pacing therapy.~   "
47057|NCT02441088|"~     Participants in this research study have tumors that express somatostatin receptors such as~     neuroendocrine tumors, medulloblastoma, meningioma, and neuroblastoma.~      Approximately 64 people will participate in this study conducted at the University of Iowa.~   "
47043|NCT02441270|"~     In metastasized of locally advanced breast cancer patients, local problems often occur like~     skin metastases, ulcerations or lymph node metastases. These problems are related to a worse~     quality of life, while overall survival is generally in the order of months to years.~     Treatment of these lesions is challenging, especially after failure of first or second line~     systemic therapy. Local treatments, like radiation, are able to give short-term palliation,~     but the effect is often disappointing in the long run. Therefore, the search for new~     therapeutic strategies like the combination of local and systemic treatments is emerging.~      Recent investigations clearly show that radiation is capable of inducing a systemic~     anti-tumor response. Both in mouse models and in patients, it was reported that irradiating~     one metastasis can slow down the growth of other non-irradiated metastases. This effect is~     called the abscopal effect and is immune-mediated. There are also several~     chemotherapeutics that are capable of influencing the immune response like cyclophosphamide.~     Cyclophosphamide is a known inducer of immunogenic cell death, which leads to the activation~     of dendritic cells and thus the presentation of antigens.~      In this pilot study the investigators wish to identify the immunological effects of combined~     treatment with radiation and cyclophosphamide in breast cancer patients. Five patients with~     metastasized breast carcinoma will be treated with the combined treatment and the~     immunological effects will be monitored using repeat blood draws and biopsies. These effects~     will be correlated to the clinical response.~   "
47044|NCT02441257|"~     Laryngeal mask airway is seldom used for control ventilation in America, while it is popular~     in China. The question is whether the incidence of gastroesophageal reflux in control~     ventilation is really higher than in spontaneous ventilation. So the investigators combine~     the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to~     evaluate the exact incidence of gastroesophageal reflux in these two groups.~   "
47045|NCT02441244|"~     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience~     of HIV infection. However, increased rates of adverse health conditions that are related to~     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in~     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T~     cell loss and the leaking or translocation of luminal gut bacteria and other microbes~     across the bowel wall and into the bloodstream.~      The use of complementary and alternative therapies is common among people living with HIV,~     however their efficacy has generally not been well demonstrated. Probiotics are live~     microbes that may provide a health benefit to the host and the investigators believe that~     the simultaneous use of probiotics along with antiretroviral therapy (ART) will improve gut~     CD4 T cell restoration and function and therefore reduce microbial translocation and immune~     activation.~      Probiotic Visbiome consists of a high potency blend of eight different probiotics. The~     precise mechanism of action of Visbiome is unknown, but preclinical studies have shown that~     Visbiome may modulate the immune response towards a phenotype that is associated with reduce~     inflammation, and Visbiome was also protective in a non-human primate model of SIV~     infection. Therefore, we believe that the beneficial bacteria from Visbiome will~     accelerate the normalization of gut immune cells and function in HIV-infected individuals as~     they start ART. Early resolution of gut immune cells may normalize microbial translocation~     and immune activation and will reduce the rates of HIV-associated comorbidities.~   "
47046|NCT02441231|"~     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience~     of HIV infection. However, increased rates of adverse health conditions that are related to~     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in~     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T~     cell loss and the leaking or translocation of luminal gut bacteria and other microbes~     across the bowel wall and into the bloodstream.~      The use of complementary and alternative therapies is very common among people living with~     HIV, with estimates ranging from 16-60%. However, their efficacy has generally not been well~     demonstrated. Probiotics are live microbes that may provide a health benefit to the host and~     the investigators believe that the simultaneous use of probiotics along with ART will~     improve gut CD4 T cell restoration and function and therefore reduce microbial translocation~     and immune activation.~      A major challenge to HIV treatment is the suboptimal CD4 T cell count despite successful HIV~     suppression on ART in immunologic non-responders (INRs). These individuals are at increased~     risk of AIDS-related deaths and non-AIDS related comorbidities that may be associated with~     increased immune activation and microbial translocation from the gut mucosa. With limited~     treatment options, alternative therapies to reduce inflammation and restore gut immunology~     will be important. Probiotic Visbiome consists of a high potency blend of eight different~     probiotics. The precise mechanism of action of Visbiome is unknown,but preclinical studies~     have shown that Visbiome may modulate the immune response towards an immunoregualtory~     phenotype with increased the levels of IL-10 and reduced levels of proinflammatory cytokines~     (TNFα, IL1β and IL-8). Therefore,the investigators believe that the beneficial bacteria~     from Visbiome will accelerate the normalization of gut immune cells and function in~     HIV-infected INRs. It is hypothesized consumption of Visbiome for 48 weeks will help restore~     the immune system in INRs who have suboptimal immune reconstitution to currently available~     ART. Resolution of gut immune cells will mean that microbial translocation and immune~     activation will be normalized and will reduce the rates of HIV-associated comorbidities.~   "
47047|NCT02441218|"~     The primary objective of this study is to demonstrate the superiority of ivabradine over~     placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart~     failure in patients with moderate to severe symptoms of chronic heart failure, a reduced~     left ventricular ejection fraction and currently receiving recommended therapy for this~     disease.~   "
47058|NCT02441075|"~     This is for a study for patients that will be undergoing hematopoietic stem cell transplant~     (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the~     most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or~     Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally~     these medications are given via the white lumen and blood is drawn via the unexposed red~     lumen to check the blood level of these medications. If these drugs are accidentally given~     via the wrong lumen (line) it could cause blood levels to be falsely high. This error could~     lead to the patient having to have peripheral blood draws that cause pain. The investigators~     are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean~     the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a~     70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is~     capped.~   "
47059|NCT02441062|"~     Participants in this study have been diagnosed with a tumor such as a carcinoid,~     neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which~     carry somatostatin receptors.~      The purpose of this research study is to see if the tumor can be identified using a special~     procedure called a positron emission tomography (PET) scan and how the results of this~     imaging procedure will change the management of the tumor.~   "
47048|NCT02441205|"~     PURPOSE: The purpose of this study is to investigate whether High Intensity Interval~     Training (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In~     particular, there is specific interest in describing the effects of an interval exercise~     program on inflammatory state and immune function.~      DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined~     by fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity~     Interval Exercise training program subjects will undergo several tests including: 1) a~     maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body~     composition, 5) several physical function tests and 6) other health related measures~     including lung function, arterial stiffness and several blood measures (e.g. liver enzymes,~     kidney function).~      DATA ANALYSES & SAFETY ISSUES: As there are no comparison groups, data analyses will consist~     of performing paired t-tests on pre and post exercise training values for each of the~     measurement variables of interest. In addition, the data will be used to provide power~     calculations for future grant proposals. High Intensity Interval Training is a very safe~     exercise modality. The regular use of vigorous intensity exercise intervals have been used~     extensively in exercise training. In fact, the exercise intervals will start at levels lower~     and will be of shorter duration than were used during the maximal exercise test. They will~     then be carefully and slowly made to be more challenging as each subject is able to safely~     tolerate.~      HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements~     in markers of inflammation, immune system markers and other health-related risk factors.~   "
47049|NCT02441192|"~     Background. The cardiovascular and cardiorespiratory coupling (CVCRC), focusing to recognize~     the synergies of standard or modified physiology that promote healthy. The investigators aim~     to study the effects of different training modalities and detraining on CVCRC.~      Methods. 32 young males were distributed in four randomized training groups: aerobic (AT),~     resistance (RT), aerobic plus resistance (AT+RT) and control (C). They were tested before,~     after the training (6 weeks) and after the detraining (3 weeks) through a graded maximal~     test. A principal component (PC) analysis of the time series of selected cardiovascular and~     cardiorespiratory variables was performed to evaluate the CVCRC. The PC1 coefficient of~     congruence in the 3 experimental conditions (before, after training and after detraining)~     was calculated for each group.~   "
47050|NCT02441179|"~     Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor~     neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In~     recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH)~     elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is~     expressed as respiratory and somatic functional recovery in animals and humans suffering~     from incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced~     motor plasticity can be harnessed to improve walking capacity in incomplete SCI patients,~     classified as C and D categories according to International Standards for Neurological~     Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients > 18~     years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset > 6~     months, neurological level C5-T12, with walking ability with or without assistive devices,~     without joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions,~     cardiopulmonary complications and a body weight below 150 Kg. A randomized, triple-blind,~     placebo-controlled parallel design study will be done including 100% of patients fulfilling~     the criteria. Participants will receive repetitive acute intermittent hypoxia (rAIH: 15~     episodes of 90 second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive~     continued normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body~     weight-supported treadmill training on 5 consecutive days and then three times per week for~     3 weeks. Primary outcome measurement will be the 10-meter walking test. Secondary outcome~     measurements include the 6-minute walking test, timed up and go test, body/weight load,~     modified ashworth scale and visual analog scale. All outcomes will be measured before~     beginning the protocol (baseline), after five days of AIH/Sham (D5), weekly up to the end of~     the study (W2-W4), and a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive~     assesment before and after the study will be performed using the Figura compleja de~     Rey-Osterrieth and the Test de aprendizaje verbal España Complutense (TAVEC). Repetitive~     AIH and body weight-supported treadmill training may represent a novel, safe, and~     noninvasive potential therapy to partially restore walking function in incomplete sub-acute~     and chronic SCI patients, a population with limited, if any, potential for improved~     function.~   "
47051|NCT02441166|"~     The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker~     of Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow~     Aspirate (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity~     close to 100% and a low false negative rate. This new test could be useful to improve the~     ability to diagnose accurately systemic mastocytosis (in particular the indolent forms).~     Because of its limited invasiveness compared to bone marrow biopsy, it could also be~     considered as a test performed before bone marrow biopsy. Only patients with high bone~     marrow tryptase would then undergo bone marrow biopsy.~      In the future and if validated by this study, bone marrow tryptase could be a useful marker~     of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.~   "
47052|NCT02441153|"~     This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be~     identified and screened for inclusion into the study once referred to a general or~     colorectal surgeon for resection of their rectal cancer. This may occur before or after~     preoperative chemoradiotherapy (CRT) but randomization will take place after CRT.~   "
47053|NCT02441140|"~     This research study is studying a possible test which may help doctors diagnose women with~     ovarian cancer.~   "
47054|NCT02441127|"~     Aims: The aim of present randomized controlled clinical study was to evaluate whether the~     additional use of diode laser would facilitate the donor surgery, improve the palatal wound~     healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with~     connective tissue (CTG) grafts.~      Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the~     de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode~     laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and~     photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using~     Oral health related Quality of life (QoL), smile related QoL and visual analogue~     scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.~   "
47055|NCT02441114|"~     This pilot study was designed to evaluate the pharmacokinetic characteristics of~     fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250~     diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for~     the patients with chronic obstructive pulmonary disease (COPD).~   "
47110|NCT02440399|"~     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for~     the mother to nurture the newborn child and establishing an appropriate mother-child~     bonding.~   "
47060|NCT02441049|"~     Entre Familia was a 4-year randomized controlled trial funded by the American Cancer~     Society. The study was conducted in Imperial County, California, and involved a partnership~     between the Institute for Behavioral and Community Health at San Diego State University and~     Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive~     primary care services to residents throughout Imperial and Riverside Counties. The~     investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13~     years old; in 25% of families, the father was also enrolled. Participants were randomly~     assigned to either an intervention or delayed-treatment control condition. The intervention~     consisted of a community health worker (or promotora)-delivered home-based intervention to~     promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual,~     both written and produced by study staff. The intervention was delivered through 11 home~     visits and 4 support telephone calls over a 4 month period. Participants in the~     delayed-treatment condition received intervention materials when evaluation assessments had~     been completed. Evaluation measures were taken at baseline, 4 months (immediate~     post-intervention) and 10 months (6-months post intervention). Participants completed a~     self-report interview with study staff at each time point. Height and weight measurements~     were also collected for the mothers and children. The primary outcomes were changes in~     mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and~     fathers included changes in fat intake, sugary beverage intake, parenting strategies, and~     perceived barriers to healthy eating.~   "
47061|NCT02441036|"~     Up to 15 subjects will be enrolled and randomized. Randomized subjects will receive one~     single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's~     scheduled facelift procedure, resected tissue will be obtained for analysis.~   "
47062|NCT02441023|"~     The purpose of this study is to evaluate the effectiveness of nutrition therapy in~     combination with education in diabetes using a multimedia application for improving~     indicators of metabolic control in patients with type 2 diabetes.~   "
47063|NCT02441010|"~     The purpose of this study is to use monitoring and intervention technologies in suboptimal~     health status in a general population in China and evaluate the effectiveness of these~     technologies in the improvement of suboptimal health status.~   "
47064|NCT02440997|"~     The purpose of this study is to preliminarily establish the extent to which a brief~     aromatherapy intervention incrementally improves subjective and objective indicators of~     discomfort (pain, anxiety, and heart rate variability) beyond passive relaxation in youth~     with chronic headaches. A secondary objective is to establish the safety of using~     aromatherapy as a treatment strategy in youth with chronic headache. The investigators~     hypothesize that children randomized to the aromatherapy condition will demonstrate a~     greater improvement in pain, anxiety, and objectively measured distress (heart rate~     variability) than comparable children receiving only a passive relaxation treatment (a foot~     bath). The investigators further hypothesize that the aromatherapy intervention will be safe~     and well-tolerated by study participants.~   "
47065|NCT02440984|"~     The purpose of this study is to assess and explain (at least apart) anorectal disorders of~     patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system~     and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic~     neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier~     dysfunctions which explain anorectal disorders of these patients. Thexpect to show a~     decreased of 5% of enteric neurons per ganglia.~   "
47066|NCT02440971|"~     Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep~     disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and~     have important prognostic implications. SDB is however, treatable with the use of non~     invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The~     aim of the study is to observe and investigate the potential role of ASV in the management~     of heart failure.~      Patients that agree to participate in this study will be requested to use an ASV ventilator~     device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is~     approximately the size of a large shoe box, which can be placed at the side of the bed, with~     tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows~     positive air pressure as determined by the device itself as it constantly monitors the~     patients breathing throughout the night. During this study, the patients breathing patterns~     will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a~     SleepMinder will sit on the patients bedside locker as another form of monitoring of their~     sleep patterns. Study staff will monitor the patient and give them frequent support, and~     they will also be asked questions regarding their experiences with this equipment and any~     symptoms they may have over this time. They will be followed up regarding this study at the~     same time as their follow-up requirements for their heart failure. This study will be~     conducted in total over 3 months.~   "
47067|NCT02440958|"~     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery~     remains the only treatment offering an advantage in terms of overall survival (5-year~     survival range, 15-25%), but unfortunately only 10-20% of patients present resectable~     disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment~     for advanced pancreatic patients, no drug or combination of drugs has significantly improved~     the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a~     survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective~     studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an~     improved safety profile in digestive malignancies. The purpose of this phase II multicenter~     study was to investigate the efficacy and safety in patients with pancreatic cancer who~     progressed in gemcitabine-based first line chemotherapy.~   "
47111|NCT02440386|"~     The iLink Study examines whether a Conditional Economic Incentive (CEI) may be an effective~     tool for improving linkage to HIV treatment and care following referral for antiretroviral~     therapy (ART) services from a mobile health clinic in Cape Town, South Africa. The study~     examines the feasibility and acceptability of using a R300 (approximately $25 as of April~     2015) voucher - that is exchanged for cash upon initiation of ART within 3 months - to~     increase the uptake of ART among men and women living in low-income areas. This pilot study~     (n=64) includes a randomised control trial, follow-up telephone calls and medical record~     reviews, and in-depth interviews.~   "
47068|NCT02440945|"~     It is about an interventional study.The use of the blotting paper called Dried Blood Spot~     or DBS is a method of systematic neonatal screening of the metabolic diseases. Indeed, it~     has multiple interests: realized thanks to lancets, it is much less invasive than a classic~     blood collection. Besides, the transport of the blood sampling is facilitated because most~     of the analysts are stable on DBS at room temperature one week or more. Finally the use of~     this DM reduces the infectious risks bound to the manipulation of the blood sampling and to~     the inactivation of microorganisms. The moderate results are vitamin D, albumin, prealbumin,~     CRP, orosomucoide~      The DBS presents a major interest for the care of the old and fragile people who have on one~     hand a low peripheral venous capital and on the other hand for whom the possibility of a~     dosage on DBS will allow a facilitated biological follow-up. Indeed it is very important to~     detect as soon as possible the most fragile old people, those who have the biggest risk of~     seeing their health degrading during a physical, psychic or social stress, to concentrate~     the efforts of coverage and limit these risks. The advantage of the biological criteria is~     the speed of the test making (a blood test), in the absence of necessity of active~     participation by the patient (the clinical criteria require to test the patient in the~     walking, to test its muscular strength, etc.) and in the saving of time diagnosis for the~     clinician. The blood biological markers of the fragility are essentially the rate of 25OH~     vitamin D, the markers of undernutrition (albumin, prealbumin) and of the inflammation (CRP,~     orosomucoïde). These last four parameters are now measurable from the DBS thanks to the~     quantitative mass spectrometry.~   "
47069|NCT02440932|"~     Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an~     inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood.~     High blood Phe levels can cause mental, behavioural, neurological, and physical problems.~     Thus, low-phenylalanine diets help patients to manage their condition but it is not clear~     whether they have an impact on appetite, energy intake and changes in body weight. This is~     important to explore as prevalence of obesity in this population is rising high. This study~     aims to find out the effect of PKU-type meals on appetite, appetite biomarkers, and~     post-meal energy expenditure. The investigators will recruit 26 healthy adults and ask them~     to participate in two experimental trials. On one occasion the participants will be asked to~     consume a PKU-supplemented drink followed by a PKU type-lunch and on another occasion the~     supplement and lunch will be based on normally consumed foods. Series of blood samples will~     be taken and appetite will be assessed during both experiments. Both experimental trials~     will finish with consuming an all-you-can-eat buffet.~   "
47070|NCT02440919|"~     This is a double crossover study where all patients are randomly allocated to one of two~     treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two~     suctioning methods for each patient: one involving hyperoxygenation with administration of~     100% oxygen 1 minute before and after suction (intervention I), and the other~     hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same~     way.The second treatment (B) uses a technique of hyperinflation with the mechanical~     ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP~     offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal~     oxygen supply in the same way.~      All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B~     on Day 1. Patients received two treatments, at least four hours apart. The first treatment~     is in the morning and the alternate treatment is performed in the afternoon. On Day 2 the~     order of the treatments was reversed using the same patient position sequence.The~     interventions I and II are performed at least 4 hours apart to minimize any carryover~     effect.~   "
47071|NCT02440906|"~     The Wellness Incentives and Navigation (WIN) project is designed to help improve health~     self-management and reduce the incidence and consequences of chronic disease among~     non-elderly adult Medicaid Supplemental Security Income (SSI) beneficiaries. WIN targets SSI~     beneficiaries with behavioral health (mental health and substance abuse) diagnoses. Research~     demonstrates that these individuals are more likely to suffer chronic physical~     co-morbidities, experience debilitating chronic illnesses earlier in life and have elevated~     healthcare costs.~      WIN uses person-centered wellness planning and navigation facilitated by trained,~     professional health Navigators, dedicated specifically to the WIN project, who use~     Motivational Interviewing (MI) techniques, and a personal wellness account. Participants~     with more serious mental illnesses will be offered additional support in the form of~     Wellness Recovery Action Planning (WRAP) to enable them to take full advantage of~     person-centered wellness planning.~   "
47072|NCT02440893|"~     The study goal was to understand the effect of Metformin on Corus® CAD (henceforth Corus)~     in pre-diabetic patients who are medication naive. This study provided data to determine if~     the Corus gene expression signature was different in pre-diabetic patients when metformin~     was newly prescribed and taken.~   "
47073|NCT02440880|"~     Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of~     the hospital resources and the continuous need to decrease the costs, work load and medical~     stuff engagement. One of the most common problem is the need to control pain post~     operatively, this issue increase the work load over the pain management team and increase~     lead to patient in satisfaction.~      This study will test the usage of dexamethasone with different doses (4 and 8 mg) either~     locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis~     plane) block to prolong the duration of the block and decrease the need of post-operative~     analgesics.~   "
47074|NCT02440867|"~     The purpose of the study is to test a new treatment of social cognition deficits in patients~     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation~     (theta-burst). The study will also identify clinical variables, cognitive and psychomotor~     most sensitive to treatment, to estimate the most sensitive treatment target, assess~     tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on~     the brain a multimodal imaging study and compare the imaging variables (resting network,~     Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients~     before treatment and healthy subjects.~   "
47459|NCT02435836|"~     The primary objective of the study was to determine the safety of aripiprazole administered~     long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects~     with chronic or first episode of schizophrenia. Information on the continued efficacy of~     aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until~     aripiprazole was otherwise available through marketed means and/or reimbursed).~   "
47075|NCT02440854|"~     This non-interventional study will include a representative sample of patients with locally~     advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in~     Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment~     with the study medication (afatinib, GIOTRIF®) will be treated according to the local~     prescribing information and standard medical practice in terms of visit frequency and types~     of assessments performed.~      The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related~     symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting~     in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale~     (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.~      The overall study duration period is expected to be 48 months, including a 36-month~     enrollment period and a minimum 12-month follow-up period.~   "
47076|NCT02440841|"~     The purpose of this study is to investigate the potential for co-administration of strong~     inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.~   "
47077|NCT02440828|"~     This study evaluates the addition of tobramycin inhalation treatment to standard intravenous~     therapy in the treatment of ventilator associated pneumonia.~   "
47078|NCT02440815|"~     The specific focus of this study is to gather data regarding the effects of a psychological~     therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray~     matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive~     function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will~     be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes~     will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive~     function, and change in depression severity from baseline to the end of 12 weeks of PST.~   "
47079|NCT02440802|"~     Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists~     or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy,~     severity and frequency of side effects of ADT vary from a patient to another. The exact~     cause of this variability is not known, however certain genetic polymorphisms affecting~     enzymes implicated in the synthesis and metabolism of sex-steroids seem to be involved in~     these processes.~      To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms~     affecting genes in the sex-steroid synthesis and metabolism pathway (CYP1A1, CYP1B1,~     CYP19A1, 17HSD, HSD3B1, AR, ESR1, ESRRG, IL6, TNF-alpha) in men with Prostate Cancer~     receiving ADT and the possible association between polymorphisms and frequency and severity~     of side-effects of ADT.~   "
47080|NCT02440789|"~     The purpose of this study is to find out about the safety of sirolimus in individuals with~     HIV infection who are also being treated with ART. The investigators want to learn whether~     sirolimus will decrease inflammation and immune activation in the body; whether sirolimus~     will change the level of HIV in the participants' blood; and how sirolimus interacts with~     ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent~     organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus~     has also been used for the prevention of complications after stem cell transplants and as a~     treatment for certain kinds of cancers in HIV-infected patients.~   "
47081|NCT02440776|"~     Monitor the safety and performance of the Pulsante Microstimulator System.~   "
47082|NCT02440763|"~     The key goals of EUROSCA-NHS is to determine and compare the rate of disease progression in~     SCA1, SCA2, SCA3 and SCA6 including determination of the order and occurrence of non-ataxia~     symptoms, assessment of activities of daily living (ADL) and quality of life (QoL), and~     identification of predictors of disease progression and survival.~   "
47083|NCT02440750|"~     The presence of a thin endometrium has an important role in allowing the best conditions for~     hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day~     administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial~     preparation to operative hysteroscopy.~   "
47084|NCT02440737|"~     This pilot clinical trial studies the Navigated Early Survivorship Transition (NEST)~     intervention in improving survivorship care planning in patients with newly diagnosed cancer~     and their caregivers. A survivorship care planning session (SCPS) delivered to survivors and~     their primary caregivers may improve psychosocial well-being, patient and caregiver~     engagement, and adherence to treatment and follow-up recommendations. It is not yet known~     whether a NEST intervention or usual care is better in improving survivorship care planning~     in patients with newly diagnosed cancer.~   "
47085|NCT02440724|"~     The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).~   "
47086|NCT02440711|"~     The goal of this study is to evaluate endurance, walking performance, mobility, and~     perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a~     conventional energy storing prosthetic foot (ESF) and a novel modified running-specific~     prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF~     provides superior performance to the ESF, which is commonly prescribed to most active~     individuals with lower limb amputation.~   "
47087|NCT02440698|"~     The investigators will use a web-based survey to collect data on individual attitudes and~     self-reported health behaviour changes following genetic testing for personalized nutrition.~     Participants (n=80) are employees of a large multi-national food company's R&D division~     located in Australia, Switzerland, USA and the UK. They underwent a genetic test for~     personalized nutrition in March 2015 that was offered at no cost through the company~     wellness program. A registered dietitian completed a pre-test consultation and disclosed the~     test results with DNA-based dietary advice. The test provided information on 7 components of~     diet and additional information on individual risk for gluten intolerance.~   "
47088|NCT02440685|"~     This study is a dose escalation, and cohort expansion study in subjects with advanced cancer~     (excluding cancer with extensive bone marrow involvement such as leukemias and multiple~     myeloma) for which no standard therapy exists. Subjects must have received prior treatment~     for cancer that has not worked, or has stopped working.~   "
47089|NCT02440672|"~     The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR~     Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total~     knee replacement.~   "
47090|NCT02440659|"~     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to~     identify factors that matter the most to patients with kidney disease and study how they are~     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient~     advocacy organizations as research partners will assure that the study addresses questions~     of greatest relevance to patients facing the need for dialysis.~      Aim two is based on preliminary results of Aim one interviews, and in collaboration with the~     Patient Advisory Panel, the investigators developed a brief questionnaire to be administered~     to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal~     Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the~     questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and~     peritoneal dialysis (PD).~   "
47091|NCT02440646|"~     In a prospective cohort single-center observational study, 720-1080 chest pain patients~     ('all-comers' REALITY registry of CTA patients, Ural Institute of Cardiology, Yekaterinburg,~     Russia; www.cardio-burg.ru) with or without acute coronary syndrome will be enrolled who~     admitted to the chest pain outpatient center (The Heart Clinics, Yekaterinburg, Russia;~     www.hclinic.ru) between September 2010 and May 2015 underwent functional testing and~     computed tomography angiography, and/ or 3D quantitative coronary angiography with or~     without further percutaneous coronary intervention. Subsequent plaque burden/ % stenosis~     (adjusted with technical limitations of CTA and 3D QCA), major adverse cardiovascular events~     (death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due~     to unstable or progressive angina) will be judged to be related to either originally treated~     (culprit) lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of~     CTA vs 3D QCA in two real-world patient flows of the Chest Pain center will be estimated~     with the special focus on safety (contrast-induced nephropathy, radiocontrast-induced~     thyroid dysfunction, and radiation dose). The diagnostic accuracy of both CTA and 3D QCA~     will be analyzed in deceased patients.~      The follow-up period will achieve 3-5 years when retro- and prospectively collected clinical~     events and imaging outcomes will be determined at the hospital, in 1, 6, 12, 24, 36, 48 and~     60 months after the first imaging examination.~      The independent ethics expertise will be provided by the Ural Medical University,~     Yekaterinburg, Russia (www.usma.ru). The monitoring of the clinical data with imaging as~     well as further CoreLab expertise (software of Medis) will be provided by De Haar Research~     Foundation, Rotterdam, the Netherlands.~   "
47092|NCT02440633|"~     To obtain absorption, metabolism and excretion data for parent drug and any metabolites.~   "
47093|NCT02440620|"~     This study will describe the epidemiology including prognosis of heart failure related to~     treatment with anthracycline and trastuzumab for breast cancer.~      In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast~     cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be~     offered advanced echocardiographic examination, test of bio-markers and genetic markers for~     the purpose of investigating if early identification of patients in particular risk of~     developing heart failure is feasible.~   "
47094|NCT02440607|"~     Clinical decision support tools with in the electronic medical record can improve clinical~     care processes. To date, there is little evidence evaluating crisis management with such~     decision support tools. The investigators aim to create an electronic cognitive aid with~     embedded decision support to aid clinicians during the management of a crisis. In order to~     test the effectiveness of this tool, investigators seek to compare the simulated medical~     management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated~     card) versus a dynamic electronic visual aid with decision support.~   "
47095|NCT02440594|"~     The purpose of the current project is to evaluate the impact of the PACE/PACENET BHL~     clinical program on older Pennsylvanians and to evaluate the feasibility and impact of an~     enhancement to the current clinical program. In order to meet this objective, the following~     primary questions will be addressed in the current project: Is the current PACE/PACENET BHL~     Clinical Program associated with improvements in behavioral health outcomes among older~     adults newly prescribed an antidepressant, antipsychotic, or anxiolytic? Is the current~     PACE/PACENET BHL Clinical Program associated with improved access to and delivery of~     evidence-based care? Is the Enhanced PACE/PACENET BHL Program associated with better~     outcomes than the current PACE/PACENET BHL Clinical Program?~   "
47096|NCT02440581|"~     Renal osteodystrophy (ROD) represents the bone histologic abnormalities resulting from loss~     of renal function. It starts early during the loss of kidney function and is seen in~     virtually all chronic end stage kidney disease patients on dialysis (CKD-5D). A major~     component of ROD is bone loss leading to chronic kidney disease (CKD) associated~     osteoporosis. Debilitating hip fractures occur in patients with CKD at a rate 4.4 times~     higher than in the general population, with associated high costs, morbidity and an annual~     mortality of 64%. CKD osteoporosis is distinctly different from post-menopausal~     osteoporosis. Presently, no uniformly accepted CKD osteoporosis treatment protocol exists~     because of challenges related to racially specific bone turnover states. Therefore, most~     physicians are reluctant to treat this disorder despite the profound impact on health and~     quality of life, and its association with vascular calcifications. These vascular~     calcifications confer an increased risk for cardiovascular events which are the major cause~     of the over 20% annual mortality rate in CKD-5D patients.~      The goal of the proposed controlled randomized study is to test the concept that CKD~     osteoporosis can be successfully treated when treatment is individualized by patients'~     turnover status. The study will demonstrate that reversal of bone loss can be achieved by~     increasing bone formation in low turnover patients, and by reducing bone resorption in~     normal or high turnover patients. A second aim of this study is to provide new information~     whether these treatments will also retard progression of vascular calcifications. Blood~     tests measuring FGF23, indicators of Wnt pathway activity, bone resorption and formation~     will be followed to understand potential mechanisms and to evaluate their usefulness for~     prediction of changes in bone mass and vascular calcifications.~      CKD-5D patients with established osteoporosis will be enrolled into one of two treatment~     arms based on bone turnover status. Each arm will be adaptively randomized by race, age and~     gender into treatment or control groups. In the low turnover arm, teriparatide combined with~     cinacalcet will be given, and in the normal or high turnover arm, alendronate will be~     administered. Bone mineral density will be measured at baseline and after one year of~     treatment by quantitative computed tomography. Calcifications of the coronaries, aorta and~     heart valves will also be measured at the same times by multi-detector computed tomography.~      If this proof-of-concept study is successful, it will offer a heretofore unavailable~     treatment for osteoporosis in CKD-5D patients thus changing the prevailing clinical practice~     paradigm. This will provide immediate benefit to CKD patients by reducing fracture risk,~     bone pain, and cardiovascular risk, while greatly improving their quality of life. These~     improvements will also convey major socioeconomic benefits by decreasing the high associated~     treatment costs. The proposed study is highly relevant to the National Institute of Diabetes~     and Digestive and Kidney Diseases' mission of disseminating science-based information to~     improve the health and quality of life for patients with endocrine, metabolic and kidney~     diseases.~   "
47097|NCT02440568|"~     This is a dose escalation study to evaluate Omacetaxine when given in combination with a~     standard induction regimen of 7+3 (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in~     patients with newly diagnosed acute myelogenous leukemia (AML).~   "
47098|NCT02440555|"~     Type 2 diabetes is the chronic disease with the most important development in France, and~     particularly in the Saint-Etienne area due to his specific population.~      Different studies showed the interest of screening targeted on high risk population to~     reduce cardiovascular risks and mortality.~      The current screening recommandation is an opportunist targeted screening on population~     older than 45 years with risk factors by a fasting glucose every 3 years, and a~     communautaire screening targeted on population older than 45 years suffering precarity with~     or without risk factors by capillary blood glucose or fasting glucose.~      The objective of the Sainté Diabete network is to optimize the screening of diabetics, their~     follow-up and their treatments. Using a self-administered questionnaire during a medical~     visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.~   "
47099|NCT02440542|"~     The purpose of this study is to evaluate outcomes of popliteal nerve blocks for~     postoperative pain control in patients undergoing ankle and hindfoot reconstruction~     surgeries. The following outcomes will be analyzed: length of hospital stay, level of pain~     control, pain medication use, complications, and patient satisfaction.~   "
47100|NCT02440529|"~     In this study, the investigators are interested in evaluating the impact of an orthopaedic~     related smoking cessation discussion after fracture surgery.~   "
47189|NCT02439372|"~     Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis~     flare, as a flare-worsening factor or simple bystander, are debated. Theoretically,~     CMV-specific cell-mediate immune response will further categorize the patients into high or~     low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific~     ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV~     colitis on ulcerative colitis flare.~   "
47101|NCT02440516|"~     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system~     (CNS) and the most common cause of non-traumatic disability in young adults in western~     countries. Despite increasing therapeutic options to ameliorate the disease course, most~     patients suffer from persistent neurological deficits over time.~      Disability in MS has a negative impact on patients life's impairing activities of daily~     living (ADL) and quality of life (QoL) and leading to loss of work and the need providing~     care. This results in tremendous socioeconomic burden.~      Disease-modifying treatments prevent disability progression in variable extent. However no~     drugs are available ameliorate persistent disability in MS. Therefore, exercise training as~     well as physical and occupational therapies are important in the symptomatic treatment of~     MS.~      Physical and occupational therapy is usually performed close to patients home by therapist~     with different professional background in a non-standardized way.~      The investigators therefore aim to develop a standardized comprehensive ambulatory~     neurorehabilitation program, integrating task oriented circuit training for MS patients to~     improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital~     settings.~   "
47102|NCT02440503|"~     The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that~     included breastfed infants consuming different infant solid foods. The investigators results~     showed that different solid foods, especially the protein content of the food, is important~     on infant's gut bacteria profile and growth. Although the first year of life is critical in~     obesity development later in life, data are very limited on the effect of protein from solid~     foods, an important component of infant diet, especially in breast-fed infants. In this~     study, the investigators will re-contact these participants, who are now in their early~     childhood (~5 years old), to evaluate the long-term effect of various macronutrient~     quantities in solid foods, by assessing the participants' growth, body composition, and gut~     bacteria profile.~   "
47103|NCT02440490|"~     Cognitive difficulties often occur with chronic pain. The aim of this randomised controlled~     trial is to determine whether various aspects of cognitive function can be improved. An~     8-week course of cognitive training via a web-based training program (3 times per week) will~     be contrasted with watching informative documentary videos (for the same length of time).~     Outcomes include subjective and objective measures of cognition, as well as self-report~     measures of mood and pain.~   "
47104|NCT02440477|"~     Background: Shoulder pain is the third most common musculoskeletal problem accounting almost~     21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT)~     are mostly common above the age of 40. Deviations of posture in the upper quadrant such as,~     slouched posture and forward head position, have been linked repeatedly to rotator cuff~     diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No~     study yet examined the effect of changing posture in sitting on the output of shoulder~     clinical tests, in patients with RCDT.~      Objectives: The primary objective of the study is to examine the effect of changing posture~     in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative~     tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of~     100 subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare~     Services in Holon and Hertzlyia) will be included in this study and divided into 2 groups:~     50 subjects with shoulder pain who are diagnosed with RCDT by ultrasound and a control group~     of 50 volunteering subjects without any pain in the upper quadrant. All patients will be~     measured for their body weight and height and their hand dominance will be notified.~     Following reliability trials on the first 10 subjects, all subjects will be tested for pain~     provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder~     tests for the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity =~     46% Neer test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity~     = 79%, specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture,~     and upright posture with scapular retraction as described by Kalra et al (2010). In~     addition, the rotator cuff muscle strength tests during shoulder abduction, internal~     rotation and external rotation will be measured for the 2 shoulders using a hand-held~     dynamometer.~   "
47105|NCT02440464|"~     This study is designed to compare progression-free survival (PFS) from randomization among~     patients randomized on the BMT CTN 1302 protocol, Multicenter Phase II, Double-blind~     Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell~     Transplantation for High Risk Multiple Myeloma. It is hypothesized that Ixazomib~     maintenance therapy will result in improved PFS in patients with high-risk multiple myeloma~     following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo.~   "
47106|NCT02440451|"~     This study aims to demonstrate that fMRI neurofeedback training improves the identification~     and comprehension of emotional facial expressions (and overall social behaviour) in subjects~     with ASD.~      The intervention setup provides structured presentation of emotional facial expressions and~     the associated tools for mental imagery. The investigators hypothesize that the~     accomplishment of the proposed competence training improves the subjects ability to~     comprehend facial expressions, identify emotions and be able to correctly express them.~      Intervention Type is a Device (brain computer interface using brain imaging signals) and the~     specific Intervention Name is Neurofeedback.~      Structure: (1) initial eligibility screening, (2) pre-intervention (first week of study,~     baseline outcome measures and additional evaluations), (3) intervention process (8 weeks),~     (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up~     (outcome measures at 6 months).~   "
47107|NCT02440438|"~     Clostridium difficile is responsible for up to 25% of reported antibiotic associated~     diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical~     spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to~     self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon,~     sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged~     world-wide and has been implicated in large outbreaks with increased severity, frequent~     recurrence, and significant mortality. The host immune responses can influence the severity~     of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum~     concentrations of antibodies directed against the toxins A&B of C. difficile have been~     associated with a higher risk of recurrence. However, there are conflicting reports.~   "
47108|NCT02440425|"~     The purpose of this study is to find out if the combination of Paclitaxel once per week with~     Pembrolizumab once every 3 weeks will help participants with this disease. Researchers want~     to find out the effectiveness of the drug combination to improve the delay of cancer~     progression or death and compare it to historical data for weekly paclitaxel alone, and~     assess safety.~   "
47109|NCT02440412|"~     This study evaluates the effect of a single session of Massage Therapy in salivary cortisol~     level. All participants were assessed on three conditions: Massage session, rest in supine~     position listening music, and under normal working conditions. The hypothesis of the~     investigators is that the effect of the massage action in reduction of cortisol is superior~     to only rest.~   "
47112|NCT02440373|"~     Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When~     mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The~     investigators plan to investigate whether circulating cytochrome c levels may serve as~     biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2)~     development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH~     will enroll over 8 months 100 consecutive trauma patients who require intubation for~     mechanical ventilation and survive to hospital admission. The Resuscitation Institute at~     RFUMS will measure cytochrome c levels in plasma taken upon hospital admission and~     subsequently at 24, 48, and 72 hours, with additional plasma stored for markers to be~     defined at a later time. Blood cytochrome c levels will be analyzed in relation to severity~     of traumatic injury, development of organ dysfunction, and clinical outcomes including~     survival and functional status (adjusted for covariates such as age, gender, type of trauma,~     time to stabilization, comorbidities, etc.) using information obtained as part of routine~     medical care. Successful completion of this project will support blood cytochrome c as~     biomarker of traumatic injury which could be used to identify severity, predict outcomes,~     and assess novel mitochondrial protective strategies.~   "
47113|NCT02440360|"~     Santa Clara County has partnered with Abode Services to provide 112 units of permanent~     supportive housing (PSH) for up to 6 years for chronically homeless individuals with~     multiple co-morbidities who are high cost users of services in the County. Because the~     target population of high cost users who are chronically homeless greatly exceeds the supply~     of permanent supportive housing to be made available via this mechanism, the County plans to~     use this opportunity to examine the effectiveness of PSH compared to treatment as usual by~     ethically allocating a limited resource using a lottery type system for eligible individuals~     who consent to participate in the Pay For Success (PFS) initiative. Specifically, while~     there are estimated to be over 2,500 people in Santa Clara who would be eligible for~     participation on any given night, the PFS program will only provide 112 PSH units at any~     given time. As the study duration will last six years, the investigators anticipate that~     approximately 150-200 people will be housed via this mechanism. Outcomes will be reported to~     the Institutional Review Board (IRB) on a quarterly basis and will be based on scheduled~     quarterly reports provided to the county.~      This evaluation will be a randomized controlled trial comparing the outcomes for chronically~     homeless individuals randomized to receive PSH to those who are randomized to receive usual~     care. The aims of this study are to:~        1. measure months of stable tenancy for individuals who are placed in PSH;~        2. examine differences in utilization of health services and the criminal justice system;~          and~        3. monitor the changes in use of longitudinal care.~      All data utilized for this evaluation will be County administrative data. The investigators~     hypothesize that some costly and acute health services utilization will decrease over time~     for the intervention group, while other more sustaining health services will increase.~   "
47114|NCT02440347|"~     The purpose of this study was to investigate and compare pulpal anesthesia and~     cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000)~     for anterior and middle superior alveolar nerve (AMSA) block performed by standard and~     computer-controlled delivery in healthy volunteers.~   "
47115|NCT02440334|"~     The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound~     (CEUS) can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation~     compared to contrast enhanced CT or MR (the standard evaluation). This study involves the~     off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the~     vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine~     post-cryoablation vascularity changes to screen for recurrent disease.~   "
47116|NCT02440321|"~     The purpose of this project is to develop and examine the effects of a parent-child~     interactive program to decrease the level of children's exposure to environmental tobacco~     smoke(ETS) at home, promote parents' and children's preventing strategy, knowledge of its~     hazard and attitude against environment tobacco smoke. A clustered randomized controlled~     trial was administered to school-aged children and their parents. The outcome indicators,~     children's exposure to ETS at home and increase of strategy to prevent the exposure were~     measured at baseline, 8 weeks, and 20 weeks. The other outcomes, parents' and children's~     knowledge of and attitude toward ETS, family's anti-ETS climate and its influence, and~     children's self efficacy of avoiding ETS were also measured at the same time point.~   "
47117|NCT02440308|"~     This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin positron emission~     tomography (PET)/magnetic resonance imaging (MRI) in imaging patients with prostate cancer.~     PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells~     with specific receptors on their surfaces. The PET scanner takes pictures that capture where~     the radioactive drug is lighting up and attaching to tumor cells, which may help doctors~     recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a~     magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic~     procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard~     imaging.~   "
47118|NCT02440295|"~     The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time~     tissue perfusion of lower extremity amputation sites and to develop parameters to predict~     healing of amputations at the time of surgery.~      This is a pilot study to see if the Spy Elite System is capable of recording accurate~     measurements on amputation sites to allow some correlation to healing. If this study shows~     promise for the device, the investigators would plan a larger study in which the data would~     be assessed in the operating room at time of acquisition and revision performed if needed~     based on the findings.~   "
47119|NCT02440282|"~     Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations~     (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the~     preferred modality of anesthesia. The use of sciatic nerve block has recently gained~     popularity, however, without the supporting evidence of any benefits. This study was to~     evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative~     pain in diabetic foot patients undergoing minor LEA.~   "
47120|NCT02440269|"~     The purpose of this study is to determine whether the Circadian Rhythms effects on the~     Norctrend Index in Anesthesia.~   "
47121|NCT02440256|"~     Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and~     linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused~     intervention to increase HIV testing rates, and optimize antiretroviral treatment,~     re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in~     British Columbia will be randomly allocated into three clusters. Clusters will initiative~     the intervention at different time points, or steps, with every cluster receiving the~     intervention.~   "
47190|NCT02439359|"~     A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability~     of Single Intravenous Doses of CF-301 in Healthy Subjects.~   "
47122|NCT02440243|"~     Background There is limited evidence indicating that specific immunotherapy in elderly~     patients is safe and effective. This study was performed to evaluate the safety and efficacy~     of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients~     over 60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass~     pollen.~      Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in~     elderly patients with SAR.~      Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy~     confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The~     patients were individually randomized to the active or placebo groups using a double-blinded~     method. There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V,~     Leiden, Netherlands) and 29 subjects in the placebo group monitored for three years. The~     patients were required to record each use of anti-allergy medication in a diary and use a~     visual graphic scale. The main outcome measure was the area under the curve (AUC) for the~     combined symptom and medication score (SMS).~   "
47123|NCT02440230|"~     To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with~     exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.~   "
47124|NCT02440217|"~     Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates~     and failure to increase myocardial glucose uptake in response to workload increments. The~     investigators aimed at verifying whether this pattern is influenced by the presence of~     abnormal glucose tolerance (AGT).~   "
47125|NCT02440204|"~     Intubation is a procedure that requires well relaxed muscles while general anesthesia is~     performed. In order to get adequate muscle relaxation, remifentanil, sevoflurane or both~     agents in combination have been reported as they can provide adequate conditions for~     laryngoscopy and tracheal intubation without using muscle relaxants.~      However, there were no previous studies to find the effective dose of sevoflurane in~     combination with different bolus doses of remifentanil to obtain adequate endotracheal~     intubation conditions without using muscle relaxants. The aim of this study is to~     investigate the change in the minimum sevoflurane alveolar concentration which produces an~     adequate endotracheal intubation condition when sevoflurane is combined with different bolus~     doses of remifentanil used in clinical practice.~   "
47126|NCT02440191|"~     It has been not clinically determined whether TomoDirect was dosimetrically better than~     3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study~     was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer~     patients of an Asian cohort.~   "
47127|NCT02440178|"~     The purpose of this study is to determine whether prophylaxis with micafungin is effective~     in the induction chemotherapy for newly diagnosed acute leukemia patients.~   "
47128|NCT02440165|"~     Early nursing nutrition intervention for outpatients in need of surgery~        -  Objective - To investigate the feasibility and effectiveness of screening and an early~          nursing intervention on malnutrition in outpatients in need for surgery.~        -  Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)~        -  Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of~          patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care~          plan (including nutritional drinks and energy and protein rich meals) tailored to~          individual patient requirements~        -  Comparison - Usual care (no nutritional care plan)~   "
47129|NCT02440152|"~     The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and~     the initiation of relapse after detoxification. There is evidence that deep brain~     stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin~     addiction via inhibitory action .~      The investigators hypothesise that bilateral stimulation of the NAcc will significantly~     reduce withdrawal symptoms and thus enable the patients to substantially decrease their~     Levomethadone usage.~   "
47130|NCT02440139|"~     STUDY DESIGN:~      This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study.~      OBJECTIVE:~      Primary: The primary objective of this clinical study is to prove that a user aided with~     ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung~     nodules.~      Secondary: The secondary objective of this clinical study is to prove that the reader's~     reading time is not significantly increased when aided with CRCTI.~      NUMBER OF SUBJECTS:~      Retrospective CT studies from approximately 300 patients will be included in the study.~     Approximately 100 true positive cases and 200 normal cases.~      NUMBER OF READERS:~      A reader study with at least ten (10) participating radiologists (US Board Certified) will~     be conducted.~      PRIMARY ENDPOINTS:~      Scores given by the radiologists with and without ClearRead CT Insight will be recorded and~     compared to the true status of the study-cases. The frequency of the scores for each method~     (Unaided, Aided) will be tabulated and LROC curves constructed along with sensitivity,~     specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and~     false positives per patient on normal cases will be measured.~      PATIENT POPULATION :~      The study will target approximately one hundred (100) patients whose CT nodules were shown~     to be cancer and two hundred (200) normal patients. The patient population will be~     consistent with the national lung cancer screening protocols.~   "
47131|NCT02440126|"~     The purpose of the study is to develop an improved understanding of the long term~     pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended~     dosing, and collect additional samples to explore cell-based biomarkers of natalizumab~     treatment and PML risk.~   "
47132|NCT02440113|"~     Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix~     Endoprosthesis.~   "
47133|NCT02440100|"~     This is an investigator-and-subject blind, phase 1 study to characterize the safety,~     tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day~     repeated ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated~     doses at the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects~     (part 2). The study also include an optional cohort (part 3) to evaluate the drug~     interaction between PF-06648671 at MTD and CYP3A probe, midazolam~   "
47191|NCT02439346|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK),~     and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination~     with intravenous (IV) docetaxel in subjects with advanced solid tumors.~   "
47134|NCT02440087|"~     This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients~     will be followed postoperatively for a period of 12 months. Intermediate statistical~     analyzes will be performed at 1 month, 3 months, 6 months and 9 months.~      This observational study is non-interventional, it does not change the usual care of~     patients who underwent a bariatric surgery. Data collection will be carried out during~     routine visits planned in the post-operation usual follow-up. The blood tests are part of~     the patient's usual care for his bariatric surgery.~      Surgeons will include patients for whom they have freely decided to use the dietary~     supplement Refill under the care of the treatment of obesity. The motivation of the patient~     and his commitment to the project is evaluated by the surgeon.~      The main objective is to evaluate the efficacy of the dietary supplement Refill.~      The primary endpoint is the reduction of iron deficiency.~   "
47135|NCT02440074|"~     This trial pretends to validate for clinical use a bioengineered product composed of~     mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM),~     Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three~     previous clinical trials) and a cross-linked matrix of autologous plasma patented by The~     Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These~     two groups collaborate in the present project with the team of Maxillofacial Surgery of the~     Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the~     medical aspects. The proposed trial is based on positive results obtained in previous animal~     studies performed by the present multidisciplinary team. A phase I / II clinical trial with~     10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous~     mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous~     plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery~     and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up~     tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by~     panoramic radiography and computerized tomography scan.~   "
47136|NCT02440061|"~     Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this~     research study is to determine the role of this gut hormone in the regulation of insulin~     secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize~     that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat.~     The investigators will compare insulin secretion and glucose changes during meal ingestion~     while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein~     on separate study days. AG is a form of the ghrelin hormone that has a small modification to~     it that allows it to bind to a specific receptor. The investigators hypothesize that AG has~     an effect on how the body handles glucose after a meal. AG has been approved by the U.S.~     Food and Drug Administration (FDA) for human research only. This study will also involve the~     use of a medicine called arginine, which is a naturally occurring product and found in many~     nutritional supplements. Its use in this study is investigational. The use of arginine helps~     maximize insulin release from the pancreas so the investigators can better examine whether~     AG affects insulin secretion.~   "
47137|NCT02440048|"~     To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after~     tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the~     use of bovine bone substitute (BioOss®) and to extration only as negative control.~   "
47138|NCT02440035|"~     The purpose of this study is to assess the safety and tolerability of intramuscular~     homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored~     vaccine candidate) and Ad26.RSV.FA2 in healthy participants.~   "
47139|NCT02440022|"~     This prospective, global, multicenter, randomized, controlled study is designed to evaluate~     the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared~     to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic~     abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.~   "
47140|NCT02440009|"~     The study evaluates the addition of itraconazole to glucocorticoids in management of acute~     stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will~     receive glucocorticoids while the other half will receive itraconazole and glucocorticoids~   "
47141|NCT02439996|"~     The objective of this study is to investigate the effect of different doses of intravenous~     immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a~     multicentre, prospective,randomised trial.~   "
47142|NCT02439983|"~     The study is designed to evaluate the effects of the proprietary nutritional supplement on~     cognition, mood, and brain imaging parameters following a relatively short period of~     treatment.~   "
47143|NCT02439970|"~     To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention~     of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV~     seronegative pretransplant and received a kidney from a CMV seropositive donor~   "
47144|NCT02439957|"~     • To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention~     of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and~     received antilymphocyte induction therapy~   "
47145|NCT02439944|"~     This study involves the use of personalized nicotine patch dosing as a treatment strategy~     for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose.~     Functional Magnetic Resonance Imaging scans will also be obtained from all study~     participants before and after treatment. The first aim of the study is to determine if the~     treatment method under investigation is safe and more effective at increasing quit rates in~     smokers who do not respond to standard therapy.The second aim is to determine if there are~     any treatment- or cessation-related changes in brain function.~   "
47146|NCT02439931|"~     Survivors of high grade brain tumours frequently experience increases in distress, cognitive~     challenges, and lessened quality of life. At the same time a range of barriers can make it~     challenging for these individuals to come into the clinic for appropriate psychosocial~     support. The proposed study is therefore a feasibility study that is designed to develop a~     manualized, remotely delivered psychosocial intervention for this population and then to~     test the acceptability, feasibility, apparent efficacy, and areas for improvement of the~     developed intervention. Further, a remote neuropsychological testing procedure will be~     developed and implemented and analogous questions will be asked around this procedure.~   "
47147|NCT02439918|"~     Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1~     (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1~     epidemic remain unclear; mounting evidence suggests medical interventions may have~     contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are~     viruses compatible with long-term survival but with broadly similar modes of transmission as~     HIV. The main objective was to assess the association of past intravenous treatment with HCV~     and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the~     mid-20th century may have facilitated the emergence of HIV-1 in central Africa.~      To assess the association of injectable treatments with HCV and HTLV-1 infection and to~     reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839~     elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification~     and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods~     were used to reconstruct the epidemic history of HCV.~   "
47148|NCT02439905|"~     During lung surgery, mechanical one-lung ventilation is usually mandatory to provide~     appropriate surgical condition. However, not only mechanical ventilation is associated with~     inflammatory response, but also one lung ventilation will result in detrimental effects such~     as ischemia and reperfusion injury, and systemic inflammatory responses.~      Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine~     decreased reperfusion injury, reduce the release of proinflammatory mediator and protected~     lungs from reperfusion injury in esophageal cancer patients who undergoing one lung~     ventilation from reducing oxidative stress metabolites. However, other details of protective~     effects is still unknown.~      High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be~     related to ventilator induced lung injury in several condition. Animal studies also showed~     that dexmedetomidine reduces the expression of messenger ribonucleic acid in~     lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release.~     However, clinical trials about these are still lacking.~      In this study, we will investigate the protective effects of dexmedetomidine to patients~     undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory~     markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6).~     This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect~     of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of~     further medical therapy in treating inflammation.~   "
47149|NCT02439892|"~     Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain~     and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight~     loss is attributed to lean muscle wasting that is associated with decline in physical~     function, substantial fatigue and significantly decreased quality of life. Rehabilitation~     that includes physical exercise, nutritional counselling and oral nutritional supplements~     (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot~     randomised trial is to assess feasibility, evaluate patient experiences and assess~     preliminary effects on muscle mass, physical function, nutritional status and quality of~     life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC~     patients referred for curative RT with or without chemotherapy, will be randomised to a)~     rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be~     carried out at an outpatient facility during the treatment period (6-7 weeks) and~     rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.~   "
47150|NCT02439879|"~     Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to~     this open multicenter study. Patients were free of pain medications and severe diabetic~     complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a~     decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no~     medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change~     in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the~     end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and~     the frequency of use of rescue medications. Physicians were free to manage glucose to~     maintain Hba1c close to the ADA target (HbA1c <7%).~   "
47151|NCT02439866|"~     Patients diagnosed with NAION within 14 days of onset were included. Patients were~     randomized into 3 groups. Group 1 or control consisted of 30 patients who received~     gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30~     patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company,~     Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day.~     Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in~     sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks~     Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best~     corrected visual acuity was the main outcome measure, and mean deviation index of visual~     field test and peripapillary retinal nerve fiber layer thickness were secondary outcome~     measures.~   "
47152|NCT02439853|"~     This is a study on Internet-based video-practice speech and language therapy for persons~     with primary progressive aphasia (PPA), Alzheimer's disease (AD), behavioral-variant~     frontotemporal dementia (bvFTD), or related conditions.~   "
47153|NCT02439840|"~     In the previous study, the investigators obtained the cutoff value of Bispectral Index to~     detect early deep sedation in patients with mechanical ventilation. Bispectral Index~     monitoring can be used as an adjunct tool in screening and confirming deep sedation during~     the early period of mechanical ventilation. In present study, validation test will be~     carried out to clarify the sensitivity and specificity of obtained cutoff value in screening~     deep sedation in patients with mechanical ventilation.~   "
47187|NCT02439398|"~     Development of myocardial reparative therapy for the treatment of acute ischemic cardiac~     disease, based on the intracoronary administration of allogeneic Cardiac Stem Cells (CSCs)~     to ameliorate myocardial cell death and promote cardio-regeneration.~      The study comprises two phases:~        1. Initial dose-escalation open-label safety phase comprising 6 patients. Escalation will~          start with the Maximum Recommended Safe Dose (MRSD) calculated from Non-Observed~          Adverse Events Level (NOAEL) and it is expected to finish with the target dose (TD).~          There will be no placebo group for this initial phase.~        2. Randomized double-blind placebo-controlled safety and efficacy phase in which the TD~          will be injected if the dose-escalation phase is completed successfully.~   "
47154|NCT02439827|"~     Background:~      Interventions on lifestyle among adolescents are important, but the main mechanisms that~     explain the changes (mediating variables) on lifestyle have been little explored.~     Investigators present the rationale and methods of a cluster-randomized controlled trial~     aimed to promote promotion active and healthy lifestyle (especially physical activity [PA]~     practice and reducing screen time use) among Brazilian students - the Fortaleça sua Saúde~     (Strengthen Your Health in Portuguese) program.~      Methods/Design:~      This is a school-based cluster-randomized controlled trial that included students from six~     elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The~     intervention duration was one academic semester (approximately four months) in 2014. The~     intervention strategies focused on teachers' training and activities on health in curriculum~     (including a specific training to Physical Education teachers), active opportunities in the~     school environment (availability of spaces and materials for PA) and health education~     (production and exhibition of health material at school, and distributing pamphlets to~     patients). Data collection will be performed before and immediately after 4 months of~     intervention. The primary variables include the practice of PA (weekly PA volume) and the~     screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental~     variables associated to PA and screen time use will be evaluated by standardized~     questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g.,~     self-rated health, body satisfaction), biological (general and abdominal obesity) and~     academic performance will be also evaluated in the patients. Depressive symptoms, eating~     disorders, sleep quality, objectively-measured physical activity will be evaluated in obese~     patients.~      Discussion:~      Is effective, this program will contribute to the development of public policies for active~     and health lifestyle promotion among young population, especially from low- and~     middle-income countries. The main variables (intrapersonal, interpersonal and/or~     environmental stimulus) that help the young people to adopt an active lifestyle also may be~     indicated. Finally, investigators expect that the proposed strategies may be adaptable to~     the public school reality and they may be extended to the entire school system.~   "
47155|NCT02439814|"~     The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of~     marijuana. THC is believed to be a significant factor in the addictive potential associated~     with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been~     found in alcohol-dependent individuals as compared to social drinkers, suggesting that~     changes in the sensitivity of the endogenous endocannabinoid system play a role in the~     transition from recreational drug use to substance use disorders. Thus, pharmacotherapies~     that target the cannabinoid system may be effective strategies for reducing marijuana use~     and dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone~     (PREG) inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana~     intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This~     pilot study will provide important preliminary data on the effect of an acute dose of PREG~     on cue-related craving in individuals with cannabis use disorder.~   "
47156|NCT02439801|"~     Laparoscopic cholecystectomy is accepted as gold standard in the management of~     cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2~     insufflation can cause decreased lung volumes and compliance, increased airway resistance~     and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate~     effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and~     elimination time of volatile anesthetic agent.~   "
47157|NCT02439788|"~     This research study is for patients that have a cancer called Neuroblastoma that has either~     come back after treatment or did not respond to the standard medicines used to treat it.~     This study combines two different ways of fighting cancer: antibodies and Natural Killer T~     cells. Antibodies are types of proteins that protect the body from infectious diseases and~     possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood~     cells that can kill other cells, including cells infected with viruses and tumor cells. Both~     antibodies and T cells have been used to treat patients with cancers. The investigators have~     found from previous research that they can put a new gene into T cells that will make them~     recognize cancer cells and kill them. In a previous clinical trial, the investigators made a~     gene called a chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes~     GD2, a molecule found on almost all neuroblastoma cells (GD2-CAR). They put this gene into~     the patients' own T cells and gave them back to patients that had neuroblastoma. Nineteen~     patients were treated on that study and there were no long term side-effects seen after the~     GD2 T cell infusion. As the investigators have followed the patients over time, they noticed~     that for those patients with disease at the time of their infusion, the time to progression~     (the amount of time it takes before their neuroblastoma got worse) was longer in those whom~     they could find GD2 T cells in the blood for more than 6 weeks after the last T cell~     infusion. Because of this, the investigators think that if effector cells are able to last~     longer, they may have a better chance of killing neuroblastoma tumor cells.~      Natural Killer T cells are a special subset of innate lymphocytes that can effectively go~     into tumor tissues of neuroblastoma. Inside the tumor, there are certain white blood cells~     which help the cancer cells to grow and recover from injury. Natural Killer T-cells can~     specifically kill these cells. In this study, Natural Killer T cells will be genetically~     engineered to express GD2-CAR to attack neuroblastoma cells and the white blood cells inside~     the tumor tissue.~   "
47158|NCT02439775|"~     The purpose of this study is to obtain an assessment of the efficacy and safety of renal~     denervation in the presence of three standard antihypertensive medications.~   "
47159|NCT02439762|"~     The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT)~     intervention compared to a Supportive Psycho-educational Control (SPC) condition in reducing~     the frequency and intensity of suicidal thoughts and behaviors in Veterans with Substance~     Use Disorders (SUDs) over a two-year follow-up period.~   "
47160|NCT02439749|"~     The purpose of this study is to obtain an assessment of the efficacy and safety of renal~     denervation in the absence of antihypertensive medications.~   "
47161|NCT02439736|"~     The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1~     (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of~     CT-positive subjects (as determined by an independent Neuroimaging Review Committee)~     presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).~   "
47162|NCT02439723|"~     The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the~     treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the~     160 mg dose is not well tolerated by patients, especially women. The purpose of this study~     is to determine if lean body mass and acidity in the intestinal tract impact how regorafenib~     is absorbed into the bloodstream and then broken down and removed from the body. This may~     explain the side effects experienced at the 160 mg dose, especially by women, and inform~     regorafenib dosing in the future.~   "
47183|NCT02439450|"~     This study will test whether vaccination with viagenpumatucel-L combined with strategies to~     modulate the immune response is safe for patients with non-small cell lung adenocarcinoma~     who have failed at least one prior line of therapy for incurable or metastatic disease.~     These methods collectively use the body's immune system to target the patient's own tumor.~     Immunosuppression hinders than response, and may develop in NSCLC patients in a variety of~     ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that~     disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may~     release this brake on the immune system. Tumor expression of PD-L1 plays an important role~     in patient response to checkpoint inhibitors; in general, clinical response to checkpoint~     inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes~     (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's~     anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.~   "
47163|NCT02439710|"~     The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new~     global tool to enhance the direct patient-voice in health care decision-making. Government~     and private payers increasingly value data based on patient-centered outcomes research as~     part of the overall cost-benefit evaluation of high-cost care and treatment of diseases such~     as hemophilia. This emerging dimension of the healthcare environment presents a significant~     opportunity and urgent need to improve patient organizations' ability to collect and~     interpret relevant outcomes data. More robust patient reported data will improve advocacy~     efforts to build comprehensive care programs, promote home treatment and implement~     preventative treatment regimens thus allowing advocacy arguments to move beyond emotion and~     anecdote to those grounded in real-world patient experiences and evidence. With the support~     of the National Hemophilia Foundation, a global team of investigators will lead a patient~     focused research project to investigate and directly probe patient perspectives on outcomes~     they deem relevant to their care. Through PROBE, the investigators will develop and seek to~     validate the reliability, reproducibility and responsiveness of a low cost, easily~     administrable inventory for collecting patient self-reported outcomes, burdens and~     experiences in living with hemophilia. The investigators anticipate that the metrics~     established through PROBE will allow for comparison of patient outcomes within a country~     over time and cross-sectionally between countries (regionally and globally).~   "
47164|NCT02439697|"~     This is a prospective single-arm open-labeled cohort study on dialysis patients of the~     conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the~     study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes~     include the variability in haemoglobin level, average weekly dose of erythropoietin, safety~     profile of NESP®, patients' subjective assessment of fatigue and injection pain after the~     conversion.~   "
47165|NCT02439684|"~     This is a cross-sectional study that aims to assess the sensitivity and specificity of using~     HbA1c as a diagnostic test for detecting the presence of diabetes mellitus (DM) when~     compared to the use of oral glucose tolerance test (OGTT) among Hong Kong Chinese adult who~     have impaired fasting glucose (IFG).~      The investigators will recruit around 1000 non-diabetic adult participants who have impaired~     fasting glucose (i.e. fasting glucose level between 5.6 to 6.9mmol/L) AND without symptoms~     of hyperglycaemia to undergo both HbA1c test and oral glucose tolerance test after obtaining~     their informed consent. A diagnosis of DM is confirmed when both the fasting glucose level~     and 2-hour-post challenge plasma glucose level fall into diabetic range (i.e. fasting~     glucose level ≥7.0mmol/L and 2-hour-post challenge plasma glucose level ≥11.1mmol/L) after a~     standard 75g OGTT. Participants with only 1 plasma glucose value within the diabetic range~     will be invited to repeat an oral glucose tolerance test for confirmation of their diagnosis~     as recommended by American Diabetes Association and World Health Organization. Demographic~     data of the participants including age, gender, smoking status, medical history, diet and~     activity level will be collected. Lipid profile, blood pressure, waist circumference and~     body mass index will be checked and the total cardiovascular risk in 10 years will be~     calculated for each participant using the Joint British Societies 2005 and Framingham 2008~     equations to evaluate the baseline cardiovascular risk of the participants.~      These data will be analyzed using SPSS. The primary outcomes are the sensitivity and~     specificity of HbA1c in detecting diabetes mellitus diagnosed by oral glucose tolerance test~     (the gold standard). A receiver operating characteristic (ROC) curve will be obtained by~     plotting sensitivity against (1-specificity) for each cutoff value for identification of an~     optimal cutoff point. Diagnostic accuracy will be assessed by the area under the curve~     (AUC). The differences in characteristics among participants diagnosed to have diabetes~     mellitus by oral glucose tolerance test or HbA1c will be compared using independent t-test~     or χ2 test for comparison between the 2 groups.~   "
47166|NCT02439671|"~     This study investigates a service delivery model to better support young adults with autism~     spectrum disorders (ASD) in the transition from school to the community. The effectiveness~     of the McGill Transition Support Program, a small-group format intervention (meeting once~     a week for 2 hours over 10 weeks) focusing on communication, self-determination and working~     with others skills, is measured by multiple pre- and post-program-assessments in a~     staggered enrollment trial, a variant of a randomized controlled trial (RCT).~   "
47167|NCT02439658|"~     To assess the ability of common genetic variants in aggregate to predict drug-induced QT~     prolongation in patients being loaded with dofetilide or sotalol, and validate the~     feasibility of using a smartphone device for measuring QT interval.~   "
47168|NCT02439645|"~     This is a registry to examine genetic and clinical predictors of torsade de pointes events.~   "
47169|NCT02439632|"~     prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated~     lower urinary tract infection in chinese~   "
47170|NCT02439619|"~     The aim of the project is to conduct a feasibility study of the mobile phone application~     TechCare for individuals with psychosis in the North West of England.~   "
47171|NCT02439606|"~     This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to~     manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients~     undergoing elective non-cardiac surgery that required general anesthesia with orotracheal~     intubation.~   "
47172|NCT02439593|"~     This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia~     (study group) versus chemoradiotherapy alone (control group) following neoadjuvant~     chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39~     patients based on the expected overall 1 year survival advantage of +20% over the control~     group (p0=40%).~   "
47173|NCT02439580|"~     Annona muricata L., include the leaves, is found to contain biologically active Annonaceous~     acetogenins and plant polyphenols that are important components of human diet and a number~     of them are considered to have chemopreventive and therapeutic properties against cancer.~      To confirm previous findings in in vitro, animal study and traditionally use, a human, ex~     vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of~     A. muricata leaves extract for eight weeks.~   "
47174|NCT02439567|"~     The purpose of this study is to evaluate the effects of sustained virological response in~     liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease~     treated with new all oral antiviral drugs in order to determine factors implicated in~     stiffness change and its implications for long-term follow-up.~   "
47184|NCT02439437|"~     This study looks at whether a coping skills training program can help women manage pain and~     stress after breast surgery, and lower the risk of developing chronic pain. This coping~     skills program includes eight training sessions that are done by telephone. These sessions~     will focus on strategies for dealing with pain and stress, and how to apply these strategies~     to subjects' own experiences.~   "
47188|NCT02439385|"~     Oral curcumin-containing supplement will be given to colorectal cancer patients with~     unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to~     completion of (or withdrawal from) chemotherapy.~   "
47175|NCT02439554|"~     This subproject is included in a project coordinated between program groups Evaluation of~     Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is~     to evaluate different aspects of health care received by patients with breast cancer from~     the diagnostic process, treatment, complications, survival and quality of life, to provide~     information to improve the effectiveness of interventions, reduce variability, have best~     predictive rules and increase the quality of life. The main objective of the subproject is~     to create and validate prospectively predictive rules of recurrence, complications,~     mortality, changes in quality of life in these patients at admission and one/two years of~     treatment and to evaluate the external validity of our rules to predict relapses,~     complications and mortality in the retrospective sample of patients participating in~     screening programs. Observational methodology with information available from a~     retrospective cohort of women diagnosed between 2000 and 2009 and another 2-year prospective~     follow-up included 2040 incident cases of breast cancer in 18 hospitals of 5 regions.~     Cohorts will learn clinical and health care diagnosis, tumor, treatment, hospital, follow-up~     (complications, relapse, and vital status) cost and quality of life. Prediction rules are~     created by means of regression/Cox models at the prospective sample and also investigators~     will assess the external validity in the retrospective cohort in the case of recurrence,~     complications and mortality. Expected results: There are currently no results of cohort~     analysis of the diagnostic process of care that integrates different aspects. The study will~     create tools to assist prognostic and therapeutic decision making process in these patients~   "
47176|NCT02439541|"~     Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem~     cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.~   "
47177|NCT02439528|"~     The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in~     2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and~     often major, profound impairment of gas exchange contrasting with preserved lung volumes and~     absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension~     responsible for increased mortality. Almost all patients are smokers or ex-smokers. There~     are some arguments in favor of genetic abnormalities in this syndrome of unknown etiology~     (other than smoking) including short telomeres and mutations in the telomerase complex~     genes. There are also emphysematous lesions, in patients with familial pulmonary fibrosis,~     with mutations in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome~     with SFTPC mutation. No large genetic studies have been conducted to date in the CPFE~     syndrome. Our main hypothesis is that the proportion of subjects with short telomeres is~     higher among patients with CPFE syndrome than in subjects of similar age with idiopathic~     pulmonary fibrosis but without emphysema. It has previously been shown that mutations in the~     telomerase TERT or TERC genes are mostly found in people whose telomeres are abnormally~     short. The investigators propose to use that test to identify patients most likely carrying~     a mutation, and to seek, among them, the mutations in the TERT or TERC telomerase genes. The~     objective of the study is to compare the proportion of patients with short telomeres in the~     group of patients with CPFE syndrome to that of other patients (with idiopathic pulmonary~     fibrosis without emphysema, or with emphysema without fibrosis).~   "
47178|NCT02439515|"~     The study proposes a novel rehabilitative program for the recovery of locomotor abilities in~     post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a~     biofeedback cycling training combining voluntary effort and Functional Electrical~     Stimulation (FES) of the leg muscles, and a biofeedback balance training is superior to~     usual care in improving walking abilities, disability, motor performance, and independence~     of post-acute stroke patients. The innovative approach is to investigate whether~     interventions which do not directly involve locomotor functions but movements similar in~     terms of kinematic patterns and neural commands (e.g. pedaling), or aimed at recovering an~     essential prerequisite for walking, such as postural control during upright stance, may~     improve and/or accelerate the recovery of walking abilities.~      A single-blind randomized controlled study is carried out. Participants are post-acute~     stroke patients experiencing a first stroke less than 6 months before recruitment, with an~     adult age, a low level of spasticity of the leg muscles (Modified Ashworth scale <2), no~     limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are~     randomized to one of two groups, one performing the novel rehabilitative program in addition~     to usual care (experimental group), and one performing usual care alone (control group).~      The experimental program consists of 15 sessions of FES-supported voluntary cycling training~     followed by 15 sessions of balance training. Both cycling and balance training are supported~     by a visual biofeedback in order to maximize patients' involvement in the exercise and are~     performed in addition to usual care.~      The control group is involved in standard physical therapy which includes stretching,~     muscular conditioning, exercises for trunk control, standing, and walking training, and~     upper limb rehabilitation.~      Both training programs last 6 weeks and patients are trained daily for about 90 minutes.~     Cycling and balance training last about 20 minutes; thus, patients in the experimental group~     perform only about 70 minutes of usual care.~      Participants are evaluated at baseline (T1), after the end of the cycling training or after~     3 weeks of usual care (post-treatment, T2), after the end of the whole intervention~     (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).~   "
47179|NCT02439502|"~     The intent of this study is to evaluate the performance and usability of Fuse in routine~     practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy)~     gastrointestinal endoscopy procedures. The study is open label, prospective and Post~     Marketing study.~   "
47180|NCT02439489|"~     PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K~     pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of~     PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive~     towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I~     PI3K-inhibitor.~      The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120~     and cisplatin or carboplatin in patient with pathologically confirmed recurrent or~     metastatic advanced solid tumor, for which treatment with a platinum agent is indicated~     (preferentially head and neck, NSCLC, ovary, endometrial).~      The primary objective of the study is to define the phase II recommended dose of daily oral~     BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1~     every 3 weeks.~   "
47181|NCT02439476|"~     Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of~     clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve~     responses to subsequent antimyeloma therapies, the duration of response decreases with~     successive relapses until resistant disease develops. Until recently, the median survival~     following relapse after induction therapy was approximately one year. The relatively recent~     US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination~     lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM~     has provided effective therapeutic options that give patients with relapsed or refractory MM~     the prospect for a prolongation of overall and progression-free survival times. However, MM~     remains an incurable disease. A clear unmet medical need still exists for additional novel~     therapeutic options for the treatment of previously treated MM.~      Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and~     was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral~     blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a~     3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the~     combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic~     progenitor cells in front-line or as salvage therapy in patients with multiple myeloma.~      Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the~     survival curves. At the time of disease recurrence, there is not one standard salvage~     approach, but instead, various therapeutic options are available, including novel~     agents-based therapy, administered for a fixed duration of time or until progression. In the~     pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM,~     the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide~     in combination with dexamethasone in the same group of patients, the median time to~     progression was approximately 11 months. A more recent prospective, randomized, phase 3~     study has shown that a triplet combination of bortezomib, thalidomide and dexamethasone~     (VTD) achieved superior results compared to thalidomide dexamethasone (TD) alone in patients~     relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months,~     respectively. This study suggests that combinations consisting of both an IMiD and a~     proteasome inhibitor are a valuable option at the time of relapse.~      However, when a frozen graft is available, it is also possible to repeat high-dose therapy~     in patients who previously responded to the frontline application of high-dose melphalan and~     ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy.~     The majority of data are available from retrospective studies and are based on single-centre~     experiences with small numbers of selected patients. In this setting, PFS has been shown to~     range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging~     from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the~     duration of response to the first high-dose therapy, or the number of lines of therapy prior~     to salvage ASCT.~      With this background, this prospective non-interventional multicentre study will aim to~     collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell~     mobilization in relapsed MM, according to Plerixafor label in France.~      This is a non-interventional study; visit will be performed as usual, according to each~     center practices. No additional visits will be requested for the study purpose. The date for~     each visit and any data generated must be recorded on the appropriate eCRF.~      The study will consist of 3 periods:~        -  An early screening period~        -  Autologous stem cell mobilization period~        -  High dose melphalan therapy and autologous graft infusion and follow-up for12 months~          after salvage ASCT Inclusion visit~      This visit may occur up to 28 days before Mozobil® administration. This visit will be~     performed during the visit of pre-transplant assessment. For the pre-transplant assessment,~     the procedures are performed routinely before ASCT even if the patient is not included in~     the study:~      Stem cell mobilization phase The stem cell mobilization phase is performed according to~     standard practice of each participating centre.~      Follow-up visits High dose melphalan administration and autologous graft infusion will be~     performed according to each centre standard practice. Patients will be followed according to~     each center practices. The follow-up of this non-interventional study will end 12 months~     after ASCT.~      Subjects will be enrolled over a 2 years period. The total duration of the study will be 36~     months~   "
47182|NCT02439463|"~     The present study assesses the health-related quality of life and the locomotor capabilities~     major traumatic lower limb amputees who use prosthesis.~   "
47185|NCT02439424|"~     Recent advancements with implantable cardiac device technology include extensive diagnostic~     and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias~     (ATA). Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm~     (Reactive ATP™) in conjunction with managed ventricular pacing (MVP) recently has been shown~     to reduce progression to permanent atrial fibrillation (AF) in pacemaker patients with~     intact atriovenous (AV) conduction and a history of ATA. Whether the use of Reactive ATP™~     for reducing AF burden extends to patients with an implantable cardioverter defibrillator~     (ICD), who typically have structural heart disease and heart hailure (HF), is unknown.~   "
47192|NCT02439333|"~     The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive~     pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas~     analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2＞45mmHg) or have achieved the traditional~     noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter,~     venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen~     concentration methods with inadequate heating and humidifying lead to poor patient tolerance~     and adverse reactions such as airway secretions discharge disorders. The high flow nasal~     respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional~     low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of~     up to 60 litres per minute via nasal cannulas with low level continous positive airway~     pressure. This study is a prospective randomized study. AECOPD patients with no severe~     respiratory failure are treated with NHF and conventional oxygen therapy respectively. The~     target is that NHF can increase the comfort degree of patients,reduce the rate of~     endotracheal intubation, and shorten the time of hospitalization.~   "
47193|NCT02439320|"~     This is a prospective randomized, double-blind, placebo-controlled study in subjects with~     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).~   "
47194|NCT02439307|"~     A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will~     be evaluated with five psychometric tests and critical flicker frequency to diagnosis~     minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients~     with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial~     overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per~     day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical~     history, nutritional assessment, biochemical studies, and evaluation of quality of life will~     be performed in all patients included in the study. Besides the initial visit, patients will~     receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.~   "
47195|NCT02439294|"~     Coronary artery disease is a common and serious disease, the leading cause of death~     worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in~     coronary artery disease where it could be involved in the pathophysiology and perhaps~     prognosis. The entanglement of the two pathologies is actually quite well known, in~     particular the consequences of one over the other just beginning to be studied.~     Understanding the pathophysiology through new imaging modalities should improve the~     management of patients to propose new approaches.~      SAS-IDM is an interventional and prospective study conducted at the University Hospital of~     Montpellier. Patients will be divided in three groups depending of the results of the~     polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate~     OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the~     group severe OSA.~   "
47196|NCT02439281|"~     Background: Millions of pediatric patients undergo laparoscopic surgeries every year and~     many of them suffer significant pain and anxiety. Patient's anxiety correlates with the~     severity of pain and effective postoperative analgesia is necessary for optimal recovery.~     Single injections ultrasound guided rectus sheath blocks provide satisfactory postoperative~     analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching~     for a blocking agent that last long enough to outlast pain and has minimal side effects is a~     difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies~     showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks,~     but anxiolytic properties of clonidine were not investigated. This study will compare rectus~     sheath ropivacaine blocks with ropivacaine and clonidine blocks.~      Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic~     appendectomy will be double blinded and randomized to the two treatment groups: the~     Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the~     posterior rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will~     receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be~     provided with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone~     as needed. The primary aim is to determine if ropivacaine combined with clonidine prolongs~     duration of paresthesia. The secondary aims are to determine if the use of clonidine~     decreases anxiety level, prolongs duration of analgesia, and decreases pain severity at~     umbilicus laparoscopic site, reduces the need for analgesics, improves satisfaction with~     pain control, and is associated with complications such as oversedation, hypotension, and~     bradycardia.~      Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by~     at least 50% is clinical relevant. The investigators hypothesize that rectus sheath~     injections with ropivacaine and clonidine offer improved pain management compared to~     ropivacaine alone.~   "
47197|NCT02439255|"~     This randomized clinical trial studies the effects of black raspberry compounds~     (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and~     non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters~     the oral microbiome and may increase the susceptibility to cancer by modulating normal~     host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome~     of smokers and may lower their risk of developing oral cancer.~   "
47198|NCT02439242|"~     In high perioperative risk patients, guidelines suggest intraoperative haemodynamic~     optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy~     requires an invasive monitoring and learning. Some studies tried to find SV surrogates based~     on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to~     the pulse pressure (PP) / heart rate (HR) ratio.~      The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR~     ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a~     ΔSV greater than 10%.~   "
47199|NCT02439229|"~     The Vitamin D and fetal bone length study:~      Vitamin D and its association to bone length in midterm pregnancy.~   "
47210|NCT02439086|"~     The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI~     performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced~     rectal cancer has the ability to identify patients with Complete Response.~   "
47220|NCT02438956|"~     A randomized, double blind placebo-controlled parallel intervention in adults over the age~     of 50 will be performed. Participants will receive a supplement capsule containing placebo~     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is~     hypothesized to replenish the body's reserves that may be depleted through natural aging~     process, poor diet, or due to the detoxification process for drugs. The primary end point is~     the number of healthy days experienced during the duration of the study. Secondary endpoints~     include cellular and biochemical measures from blood samples taken before and after the~     study.~   "
47221|NCT02438943|"~     To assess the effectiveness of a clinical audit and physician based intervention in~     improving the management of dyslipidemia at Health centres in the Southeast Health Region of~     Jamaica~   "
47200|NCT02439216|"~     The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy,~     pharmacokinetics (PK) and pharmacodynamics (PD) of CAT-1004 (now known as edasalonexent) in~     pediatric patients with a genetically confirmed diagnosis of DMD. Approximately 30~     ambulatory, male patients from ≥4 to <8 years of age will be enrolled overall.~      Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB,~     a molecule that is activated from infancy in DMD and which is central to causing muscle~     damage and preventing muscle regeneration. Data on magnetic resonance imaging of the lower~     and upper leg muscles, physical function (including timed function tests) and muscle~     strength will be studied.~      Part A was initiated in April 2015 and is now complete. All three doses of CAT-1004 tested~     were generally well tolerated with no safety signals observed. The majority of adverse~     events were mild, and the most common adverse events were gastrointestinal (primarily~     diarrhea). There were no serious adverse events and no drug discontinuations.~      Part B is a randomized, double-blind, placebo-controlled, multiple dose study to evaluate~     the safety, efficacy, PK, and PD of edasalonexent over 12 weeks. Patients who participated~     in Part A may also participate in Part B, along with newly enrolled patients. Following~     completion of Part B, all patients will receive CAT-1004 for 36 weeks in Part C, the~     open-label portion of the CAT-1004-201 study.~   "
47201|NCT02439203|"~     The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to~     evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment~     of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).~   "
47202|NCT02439190|"~     The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and~     clopidogrel decrease blood clotting.~   "
47203|NCT02439177|"~     The aim of this study is to determine the System Accuracy and User Performance evaluation of~     the mentioned BGM systems by gaining a sufficient amount of measured data from capillary~     blood.~   "
47204|NCT02439164|"~     Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is~     common and often necessary for patients with intracranial brain tumor. Repeated neurological~     function assessments is needed in those locations, especially in patients with tumors in or~     near eloquent regions, this is to monitor their neurologic performance to determine if there~     are alterations that require treatment. Some slowly infiltrative low-grade gliomas near~     eloquent regions do not show any detectable neurologic deficits, perhaps from~     reorganization, but with sedation by some sedatives such as benzodiazepine midazolam and~     anesthetic hypnotic propofol, the disease may seem much worse resulting in inappropriately~     aggressive treatment. This may be especially problematic in patients undergoing awake~     craniotomy for tumors in eloquent regions.~      This is a single-center perspective case-control study. Patients will be mildly sedated to~     keep them responsive and cooperative. Motor and sensory function will be evaluated before~     and after mild sedation. Specific benzodiazepine antagonist will be used if sedated by~     midazolam.~      The purpose of this study is to observe if commonly used benzodiazepine midazolam,~     anesthetic hypnotic propofol, and α-2 agonist dexmedetomidine exacerbate or unmask motor and~     sensory function in patients with intracranial eloquent area gliomas.~      Hypothesis:~      mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent~     area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic~     deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.~   "
47205|NCT02439151|"~     Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe~     acute respiratory distress syndrome (ARDS). But how to choose mechanical ventilation~     strategy is still not clear for severe ARDS patients supported by ECMO. Our previous work~     found that, compared to the traditional lung rest strategy, transpulmonary pressure guide~     new lung ventilation strategy can better maintain lung volume reduction lung collapse,~     atelectasis occurs. The severe ARDS patients receiving ECMO therapy were randomized divided~     into a new ventilation strategy group and the conventional ventilation strategy group. The~     new ventilation strategy is transpulmonary pressure guide ventilator setting method, and the~     conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide~     ventilation method. Compare the difference between the two groups of patients in lung~     injury, and explore the lung protection mechanism of new lung ventilation strategies guided~     by transpulmonary pressure. Our research group considered that transpulmonary pressure guide~     new lung ventilation strategy can provide more effective lung protection. And it will be~     further used in clinical work.~   "
47206|NCT02439138|"~     This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or~     CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).~   "
47207|NCT02439125|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of~     eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease~   "
47208|NCT02439112|"~     The overall aim is to examine whether early initiated, individualized exercise training in~     patients newly diagnosed with multiple myeloma, irrespective of age and current performance~     status, will be beneficial for the patients´physical function, level of physical activity~     and quality of life, pain and bone disease.~      The investigators will examine the effect of supervised in-hospital exercise training~     sessions combined with home-based exercise training, initiated at time of diagnosis. The~     outcomes of interest are physical function, level of physical activity, QOL, pain and bone~     disease.~      Furthermore, to describe the disease in patients with newly diagnosed MM in relation to~     physical function, level of physical activity, QOL, pain and bone condition at time of~     diagnosis.~      The investigators hypotheses are:~        -  Individualized exercise starting at time of diagnosis will have positive effects on~          physical function, physical activity, QOL and pain.~        -  Individualized exercise starting at time of diagnosis will have positive effects on~          bone disease (bone markers), bone mineral density (BMD) and lean body mass.~        -  A higher level of physical function is associated with a higher level of physical~          activity, less pain, better QOL, and higher BMD and lean body mass.~   "
47209|NCT02439099|"~     It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in~     the pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis,~     serum RA status will be assessed in healthy controls and subjects with Major Depression,~     Alzheimer's disease, alcoholism and in subjects with schizophrenia.~   "
47211|NCT02439073|"~     Purpose The purpose of the PROLUCA study is to investigate the efficacy of early~     postoperative rehabilitation in a non-hospital setting in patients with operable lung~     cancer, with focus on exercise training.~      Design/Methods~      One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small~     Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of~     the following two groups:~        1. Early postoperative rehabilitation initiated as early as two weeks after surgery~        2. Postoperative rehabilitation initiated 14 weeks after surgery Intervention The~          intervention consists of a supervised group exercise program comprising resistance and~          cardiorespiratory exercise two hours weekly for 12 weeks combined with individual~          counseling.~      The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct~     measurement) Secondary endpoints include: Six minutes walk distance (6MWD),~     One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of~     life, fatigue, depression, lifestyle, postoperative complications, hospitalization time,~     sick leave, work status and survival.~      Results The results of PROLUCA will identify the optimal timing of postoperative~     rehabilitation in NSCLC patients with focus on increasing physical capacity and health~     related quality of life and reducing the side effects from the treatment of the cancer~     disease.~   "
47212|NCT02439060|"~     This randomized phase III trial studies how well biologic mesh works in preventing~     parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy, or~     removal of the bladder, and ileal conduit diversion. An ileal conduit is a tube created from~     your small intestine that will be used as a tube for urine to flow out of your body.~     Parastomal hernia is a type of hernia that can occur in the stomach area where the ileal~     conduit is placed. Biologic mesh may help prevent parastomal hernia following surgery and~     ileal conduit diversion.~   "
47213|NCT02439047|"~     The objective of this study, which will be realised in vitro on human samples, is to test 2~     cell sources isolated from peritoneum for adult mesothelial cells (peritoneal samples) and~     from adipose tissue for the adipose stem cells (adipose tissue samples). The latter will be~     differentiated towards the mesothelial phenotype and morphotype. The 2 routes will be~     compared and the most satisfactory one will be chosen to make a non-stick patch.~   "
47214|NCT02439034|"~     The results of the study will permit to set up a standardized and validated procedure of~     pain management authorizing medical and paramedical staff of brachytherapy department to~     handle pain and in this way to improve the quality of life of the patients.~   "
47215|NCT02439021|"~     The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be~     highly safe for adult and pediatric patients. However, the LMA has some limitations and~     weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy~     insertion of the LMA, it is crucial to check correct placement of the LMA airway.~   "
47216|NCT02439008|"~     This study will follow-up immune cell populations, secreted factors and released~     nanovesicles in the blood before, during and after high dose radiation therapy which should~     give new information of the efficacy of the hypofractionated high dose radiation therapy and~     a rationale for adjuvant immunotherapy.~   "
47217|NCT02438995|"~     This is an open-label, non-randomized, two arm, Phase I research study of superselective~     intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of~     recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).~   "
47218|NCT02438982|"~     Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of~     these patients respond well to corticosteroids. However, as many as 70% of children with~     nephrotic syndrome experience at least one relapse, and 30% develop a more complicated~     course with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid~     dependency (SDNS)(relapse during tapering or within 2 weeks after discontinuation of~     corticosteroids). Repeated and prolonged courses of steroids in these children often result~     in long-term complications. The goal of the treatment is to reduce the rate of relapses, the~     cumulative dose of corticosteroids, and the incidence of serious complications. In order to~     minimize the side effects of steroid therapy, different steroid sparing agents such as~     cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF)~     have been used in SDNS. Whereas CNI are usually considered the steroid sparing drug class of~     first choice, rituximab is increasingly used as alternative to minimize CNI toxicity.~     Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody,~     could be a safe and effective alternative to steroid or immunosuppressants to achieve and~     maintain remission in this population.Single rituximab course have been shown to be~     efficacious for 6 to 12 months and the side effect profile observed to date is very benign.~     Studies comparing the usefulness of these agents are lacking. In our proposed randomized~     controlled trial, the investigators want to compare the efficacy and safety of CNI to that~     of Rituximab in treating children with SDNS.~   "
47219|NCT02438969|"~     Background:~      - Researchers want to learn if people with alcohol dependence have more difficulty learning~     to feel calm, or learn to fear things more easily. They also want to study how early life~     stress (ELS) affects the ability to learn to feel calm.~      Objective:~      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel~     calm than people without these. Also, to see if DNA is changed by ELS and if this change~     affects fear conditioning and extinction.~      Eligibility:~        -  Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without~          ELS.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  Psychological tests~             -  Treatment for symptoms of alcohol withdrawal, if needed~        -  Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will~          stay at the clinic for about 4 weeks.~        -  Participants will:~             -  Rate alcohol use/craving, depression, anxiety, and childhood trauma.~             -  Have psychophysiological measures: electrodes and mild electric shock.~        -  Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a~          table in a metal cylinder with a coil over their head. In the first scanning session,~          they will see pictures, do a simple task, and may get shocks. Participants will also do~          a second scanning session in which they will perform the aforementioned fear~          conditioning and extinction task, as well as a facial expression matching task, an~          affective word processing task, and a task measuring valuation of monetary rewards.~             -  Answer questions about their emotions (some participants).~             -  Have blood drawn from an arm vein or intravenous (IV) line.~             -  AUD participants will get a dexamethasone pill. The next day, they will get a~               hormone injected in and have blood drawn from an IV line.~        -  AUD participants will have 3 follow-up visits with questions and blood and lab tests.~   "
47222|NCT02438930|"~     This study pilot tests and intervention to help individuals reduce their risk for acquiring~     or transmitting HIV. The intervention is implemented when people are tested for HIV in an~     outpatient clinic in rural Uganda. Approximately half of participants will receive the~     intervention and the other half will receive the usual counseling provided during HIV~     counseling and testing.~   "
47223|NCT02438917|"~     Chronic liver injury leads to the accumulation of proteins in the liver that form dense~     scars. Liver scar formation is typically a slow process that leads to major organ damage and~     loss of function over the course of many years. During scar formation the extracellular~     matrix in the liver changes. The type and quantity of extracellular collagen and other~     proteins change during tissue remodeling. Some of these changes can be detected by analyzing~     factors present in blood. Because of the lengthy time course, changes in the rate of liver~     scar formation and regression are very difficult measure; however, accurate measurements are~     needed in order to conduct trials of interventions aimed at preventing scar formation and/or~     promotion scar regression. Current methods have sub-optimal specificity and selectivity. The~     long term objective of the study is to identify serum proteins that can be used to~     accurately estimate rates of liver fibrosis progression and regression. The project focusses~     on a novel methodology that uses stable isotope labeling with deuterated water, D2O, to tag~     newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to~     quantify the ratio of labeled protein to total protein. This ratio provides information~     about the rate of synthesis of the protein of interest. This method will be applied to~     specimens from patients with hepatitis C virus (HCV) infection who are about to begin HCV~     treatment. Treatment is known to reduce liver inflammation and collagen content.~   "
47224|NCT02438904|"~     Objectives:~      Primary Objective~      To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients~     who experience poor graft function after stem cell transplantation (SCT).~   "
47225|NCT02438891|"~     Most tinnitus sufferers experiences significant anxiety or depression that worsens the~     subjective symptoms related to tinnitus. In this study, we intend to use internet-based~     cognitive behavioral therapy (CBT) in addition to sound therapy to provide psychotherapy to~     patients with tinnitus. Multiple research studies have found CBT to be effective in~     improving the subjective symptoms of tinnitus. The internet-based CBT course developed for~     this study is 8 weeks in duration and organized into eight 1-week modules; each module~     contains 2-4 separate lessons and homework assignments. Patients will be given unique~     usernames and passwords. In each weekly module, patients will review educational materials~     online, do exercises. and will be given feedback based on the results of the completed~     exercises. In addition, patients are given different meditation exercises each week for~     relaxation and coping with their tinnitus. These interactive materials enable patients to~     manage and control any negative feelings and thoughts that may be associated with tinnitus~     and help take their attention away from tinnitus. Tinnitus loudness and annoyance will be~     measured before and after the program. An internet-based course enables care providers to~     monitor patients' progress with the CBT course remotely, and allows patients to learn CBT at~     their own convenience and schedule.~   "
47226|NCT02438878|"~     The primary objective of this project is to evaluate the impact on infant growth and~     infant-feeding practices of a low-cost series of video trainings and tools targeted to~     medical staff and designed to support ongoing Baby Behavior education of WIC participants.~   "
47227|NCT02438865|"~     This clinical trial is designed to compare the effect of single postoperative intravesical~     chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence~     after surgery for UTUC.~   "
47228|NCT02438852|"~     This randomized phase IV trial studies how well the continuous infusion of ropivacaine~     hydrochloride works in reducing pain after surgery in patients with bladder cancer.~     Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of~     the body without putting the patient to sleep. Continuous infusion of ropivacaine~     hydrochloride may reduce pain and improve the quality of life for patients after bladder~     surgery.~   "
47229|NCT02438839|"~     The aim of the present study is to investigate whether curative chemoradiation of low rectal~     cancer is feasible, safe and effective in a multicenter study with results comparable to~     those of single center studies.~      Results from previous studies indicate that a considerable fraction of patients with low~     rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be~     spared from operation.~   "
47230|NCT02438826|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY2951742 in participants with chronic cluster headache.~   "
47231|NCT02438813|"~     The primary objective of this registry is to develop a comprehensive understanding of the~     condition of submental (SM) fullness due to submental fat (SMF), how it is treated in~     current clinical practice, and the risks and benefits associated with its treatment.~   "
47232|NCT02438800|"~     This is a randomized clinical trial to evaluate if the addition of long-acting reversible~     contraception (LARC) focused video-counseling during prenatal care increases uptake of~     postpartum LARC.~   "
47233|NCT02438787|"~     The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha)~     refractory participants with active radiographic axial spondyloarthritis (AxSpA), as~     measured by the reduction in signs and symptoms of radiographic AxSpA.~   "
47234|NCT02438774|"~     It has been shown that exposure to mycotoxins through complementary foods and breast milk~     had profound effects on growth of children from 6 months to 1 year of age. In Tanzania maize~     is the main ingredient for complementary food, however, the crop is vulnerable to mycotoxins~     contamination. it has been reported that the most effective way to reduce mycotoxin exposure~     is to lower the mycotoxins contamination of maize. This study has developed a post-harvest~     intervention package for use in rural Tanzania to reduce contamination of maize and breast~     milk with two forms of mycotoxins; aflatoxins and fumonisins. It is composed of 5~     components; 1) hand sorting, 2) drying surface, 3) proper drying 4) application of~     insecticide, 5) dehulling and was introduced in three main maize producing agro-ecological~     zones. The intervention used randomised controlled trial design where infants less than 8~     six months of age were recruited and followed up 6 months after recruitment. The~     intervention expects to demonstrate the effectiveness of the post harvest intervention~     package in reducing aflatoxins and fumonisins contamination of maize and subsequent exposure~     of these toxins to infants and young children through maize based complementary food and~     breast milk. The findings will be used in developing guidelines for farmers and extension~     officers to reduce aflatoxins and fumonisins contamination of maize and improve the health~     of the infants and the whole population.~      The study hypothiseses that introducing post-harvest intervention package can reduce~     aflatoxins and fumonisins contamination of maize and subsquent exposure of these toxins to~     infants and young children through maize based complementary foods and breast milk than~     routine agriculture extension services offered to the farmers in rural Tanzania. The~     specific objectives include;~        -  To evaluate the effectiveness of post-harvest intervention package on reduction of~          aflatoxins and fumonisins contamination of maize and in breast milk~        -  To perform exposure assessment of aflatoxins and fumonisins to infants and young~          children through maize based complementary food and breast milk~        -  To perform risk characterization of aflatoxins and fumonisins exposure to infants and~          young children through maize based complementary foods and breast milk~        -  To assess the association between exposure to aflatoxins and fumonisins and child~          growth~   "
47235|NCT02438761|"~     Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384~     (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.~   "
47460|NCT02435823|"~     This is a prospective multi-center, single arm, non-randomized study. It is designed to~     evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation~     intracranial aneurysms.~   "
47236|NCT02438748|"~     The main objective of this study is to determine whether biological stress markers (Oxidized~     Phosphatidylcholines) in the blood can be used to predict the efficacy of rTMS in the~     treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may~     be used to determine which patients will benefit from rTMS treatment. A second objective of~     this study is to measure any changes in stress markers that occur across the course of rTMS~     therapy.~   "
47237|NCT02438735|"~     Purpose of this study is to determine if the presence of endometriomas cause a reduction in~     ovarian reserve. Endometriosis and fertility problems experience are frequent. There seems~     to be an association between endometriosis and subfertility. This study aims to asses if the~     endometrioma it self causes diminished ovarian reserve after a certain time period, with~     determination of ovarian reserve with anti-mullerian hormone (AMH), follicle stimulating~     hormone (FSH),luteinizing hormone (LH), estradiol and antral follicle count (AFC) values.~   "
47238|NCT02438722|"~     This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works~     and compares it with afatinib dimaleate alone in treating patients with newly diagnosed~     stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation~     positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, may block tumor growth in different ways by targeting certain cells. It is not~     yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in~     treating patients with non-small cell lung cancer.~   "
47239|NCT02438709|"~     The purpose of this study is to determine whether COX-2 inhibitor is effective in the~     treatment of primary hypertrophic osteoarthropathy~   "
47240|NCT02438696|"~     The primary objective is to investigate the relative bioavailability of two newly developed~     tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is~     the comparison of several pharmacokinetic parameters between the treatments.~   "
47241|NCT02438683|"~     This trial will be conducted to further evaluate, in a controlled setting, potential cardiac~     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting~     and exercise conditions. Since the drug is being developed in part for a disease with an~     expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306~     is considered to be important for the development of this compound.~      This trial will be conducted to further evaluate, in a controlled setting, potential cardiac~     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting~     and exercise conditions.~      Since the drug is being developed in part for a disease with an expectedly high number of~     elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be~     important for the development of this compound.~   "
47242|NCT02438670|"~     The goal of this proposed study is to compare use of a PID~     (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control)~     controller algorithm in an artificial pancreas system, all other components and study design~     being equal. The study design, power calculation and endpoints were developed based on the~     results of an initial feasibility study (ClinicalTrials.gov Identifier: NCT01987206) that~     has already been completed.~   "
47243|NCT02438657|"~     Ultrasound guidance can reduce the required local anesthetic volume for successful~     peripheral nerve block.~      The aim of the study is to determine the minimum volume of local anesthetic to achieve an~     ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.~   "
47244|NCT02438644|"~     This observational, noninterventional study is designed to further characterize the~     effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only~     patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell~     carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is~     estimated to be approximately 12 months.~   "
47245|NCT02438631|"~     The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK)~     models to put the generated data into context with medical conditions that require maternal~     or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life'~     maternal and fetal PK data, such as data from the PANNA network.~      Ultimately, these PBPK models of drug therapy during pregnancy will provide a powerful tool~     to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based~     research in pregnant women in the future, and 3.) guide future development of new molecular~     entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and~     potentially toxic effects in utero).~   "
47246|NCT02438618|"~     The objective of this study is to make a comparison between two surgical techniques used~     when implanting a Ponto bone anchored hearing system.~   "
47247|NCT02438605|"~     The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at~     prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional~     CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and~     post-operative will be assessed for device changes and anatomical variances.~   "
47248|NCT02438592|"~     This is an observational study involving retrospective and prospective medical record review~     covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted~     Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of~     study subjects. Data will also be collected to assess clinic level variables. Definitions of~     engagement, prescription of antiretroviral therapy (ART), and viral suppression in the~     Continuum of Care (CoC) will utilize common definitions including those by U.S. Department~     of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA)~     HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to~     provide all elements for both the primary and secondary outcomes.~   "
47321|NCT02437643|"~     The purpose of the trial is to assess the effects of combining regular, generous intakes of~     high quality protein (primarily from dairy and other animal source proteins) with calorie~     restriction and low-intensity exercise on muscle quality and muscle adipose infiltration~     (along with bone mineral density [BMD] and a number of secondary outcomes) in frail, obese,~     older adults participating in a 6 month intervention. The investigators will compare these~     effects to those of a traditional control regimen of calorie restriction and low-intensity~     exercise over the same duration.~   "
47249|NCT02438579|"~     Viral upper respiratory tract infections (URTI), one of the commonest infection faced by~     humans, have a significant impact on individuals, families, health service and economy.~     Though rhinoviruses are called the common cold virus, numerous viruses can cause URTI.~     Hence virus specific remedy for URTI is impractical. There are currently no evidence-based~     interventions that reduce the severity, symptom duration or viral shedding. Preliminary~     evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce~     the duration of symptoms.~      With this pilot randomised controlled trial (RCT), the investigators aim to assess the~     feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses~     on recruitment rate, willingness to be randomised, acceptability, compliance and likely~     effect size of the intervention.~      This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected~     mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is~     measured by a validated symptom score. A questionnaire based participant feedback will help~     assess intervention and trial procedures.~      This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost~     intervention that has the potential of substantial health and societal benefits.~   "
47250|NCT02438566|"~     The purpose of this research is to determine if the oral form of a medication (tranexamic~     acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best~     way to give tranexamic acid: either a pill by mouth, or a solution by vein.~   "
47251|NCT02438553|"~     The purpose of this study is to evaluate the short-term effectiveness of combined occipital~     and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.~   "
47252|NCT02438540|"~     The investigators designed this randomized double blind (patients/ assessor) clinical trial~     to compare the therapeutic effects of Metformin monotherapy with Metformin and acupuncture~     combined therapy on weight loss and insulin sensitivity among overweight/obese type 2~     diabetes mellitus (T2DM) patients. We compared the inflammatory markers, lipid profiles, and~     adipokines in overweight/obese T2DM patients receiving the combined therapy to those~     receiving the Metformin monotherapy, to understand whether acupuncture plus Metformin is a~     better approach then Metformin only on treating diabetes.~   "
47253|NCT02438527|"~     ABSTRACT~      Background:~      More than two thirds of sudden cardiac arrests are witnessed by bystanders. Bystander~     cardiopulmonary resuscitation (CPR) doubles survival from cardiac arrest. Importantly, even~     in witnessed cardiac arrests only 20% of the bystanders commence basic life support. Common~     reasons for not commencing include panicking and the perceived inability to perform CPR~     correctly. A meta-analysis could demonstrate that a simplification of the algorithm~     (compression-only dispatcher-assisted bystander CPR) led to a 22% increase in~     survival-to-hospital discharge. A recently published trial of the research group could~     demonstrate that the presence of a flowchart has a positive effect on the quality of BLS~     while at the same time increasing the rescuers' confidence. Nonetheless, performing CPR is~     exhausting. Previous publications have emphasized increasing fatigue with the duration of~     CPR efforts in both, standard and chest compressions-only CPR. Consequently, we wanted to~     test the hypothesis that chest compressions (CC) are delivered more correctly regarding the~     depth when utilizing the standard BLS algorithm with the aid of a flowchart as compared to~     the CC only algorithm utilizing an adapted CPR flowchart in a manikin resuscitation model.~      Methods:~      After consent of the Research Ethics Board of Medical University of Vienna and obtaining~     written informed consent of the participants, 84 medically untrained laypersons will be~     randomised to perform flow-chart assisted CPR for 300s following standard CPR guidelines or~     CC only CPR. The primary outcome parameter will be the total number of CC achieving the~     correct depth of 50-60mm. Secondary outcome parameters will be hands-off time, the total~     number of CC, and the compression rate. The total number of delivered rescue breaths, tidal~     volume, and time to deliver these will also be evaluated. Furthermore, the subjective point~     of exhaustion affecting the CPR quality, the reason for discontinuation of CPR if stopped~     within the 300sec. period and the exhaustion at the end of the CPR measures will be~     evaluated.~   "
47254|NCT02438514|"~     The investigators propose to evaluate the potential utility of stress-related biomarkers~     obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers~     and children within the New Haven MOMS Partnership, a well-established community-partnered~     research setting. The proposed research could greatly advance the application of~     stress-related biomarkers within community-based research by increasing our understanding of~     how stress, trauma, and depression influence biology in childhood and adulthood, as measured~     using minimally-invasive approaches.~   "
47255|NCT02438501|"~     Many trials that patients with advanced or recurrent indolent lymphoma managed with very~     low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable~     remission can be achieved. However, the results of two phase III trials have failed to~     demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches.~     Histology, bulky tumor (>5 cm), higher number of prior chemotherapy regimens, adoption of~     rituximab, and age＞65 years have been shown to significantly influence response rates of~     LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose~     involved-field radiation therapy in patients lower than 65 years of age with recurrent~     advanced follicular lymphoma.~   "
47256|NCT02438488|"~     Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing~     standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D). In a European~     consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program~     (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses~     using a one step procedure will be performed to study associations of original and~     standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.~   "
47257|NCT02438475|"~     Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure~     following both diagnostic and interventional procedures as assessed by clinical and imaging~     criteria.~   "
47258|NCT02438462|"~     The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing~     Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the~     Soluble Fibrin Assay and the D-Dimer test.~   "
47271|NCT02438293|"~     This is a prospective single- center observational study in the Leiden University Medical~     Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for~     congenital heart disease. The parents/guardians of the children will be asked to fill out a~     questionnaire, to asses respiratory symptoms in the last weeks, before the operation of~     their child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data~     will be collected daily during paediatric intensive care admission, and date of discharge~     from paediatric intensive care unit and from hospital are recorded. If children are still~     intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The~     samples will be tested for rhinovirus with a polymerase chain reaction. Main study parameter~     is the paediatric intensive care unit length of stay in per-operative rhinovirus -positive~     compared to rhinovirus-negative patients.~   "
47259|NCT02438449|"~     It is estimated that about 25% and 40% of health care expenditures in Canada and USA~     respectively are wasted because of inefficiencies and not practicing evidence-based~     medicine. As health care resources are scarce it behooves all of us to use these in a~     cost-effective manner. The term cost-effective is used in the health care literature often~     but erroneously. Investigators compare a novel' intervention to a prevailing one and if~     the novel intervention is less costly it is labeled cost-effective. In a methodologically~     correct cost-effectiveness study however, investigators need to integrate both the~     effectiveness and costs of the competing interventions and calculate an incremental~     cost-effective ratio. If this ratio falls within acceptability thresholds, the novel~     intervention is labeled cost-effective. There are many techniques of breast reconstruction.~     The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue~     Expansion / Implant reconstructions. In this study these two most common breast~     reconstruction approaches after mastectomy due to cancer performed in the~     Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a~     cost-effectiveness analysis coupled with a methodologically robust observational study.~   "
47260|NCT02438436|"~     Abdominal surgery, including hepatic resection for hepatocellular carcinoma (HCC), is~     inevitably followed by an episode of gastrointestinal hypomotility. A delayed return of~     gastrointestinal function, defined as postoperative ileus (POI), has a great impact on~     patient comfort, morbidity and recovery. POI often results in a prolonged hospital stay and~     contributes significantly to healthcare costs.~      Some prospective studies have revealed that gum chewing can improve the return of~     gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary~     system surgery. Moreover, some retrospective studies also revealed that simo decoction may~     improve the return of gastrointestinal function after hepatic resection of HCC. Therefore,~     the present study compared the effect of gum chewing and simo decoction after hepatic~     resection of HCC on POI, surgical complications, and length of hospital stay.~   "
47261|NCT02438423|"~     Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of~     Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.~      This is a single center, partially blinded, randomized phase I study in which healthy adult~     subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by~     microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is~     designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an~     inactivated influenza vaccine delivered by microneedle patch.~   "
47262|NCT02438410|"~     To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of~     colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab~     level based on the study results.~   "
47263|NCT02438397|"~     the study objective: to explore the efficacy of acarbose and metformin on glucose~     fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with~     premix insulin.~   "
47264|NCT02438384|"~     This is a three arm pilot randomized trial. Patients will be assigned to:~        1. Usual care~        2. Video education in the ED~        3. Video education in the ED plus phone follow-up at three days with geriatric pain~          management specialist for all patients with pain >=4/10~   "
47265|NCT02438371|"~     Tocolytic agents are used for the treatment of preterm labor. It is unclear whether~     combination treatments of two tocolytic agents are more effective in stopping preterm labor~     compared to one. Therefore, the investigators propose a comparative effective trial of~     nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor~   "
47266|NCT02438358|"~     For most breast cancer patients, surgery is the primary treatment. When patients undergo a~     lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which~     results in incomplete tumor removal as determined by a positive margin assessment several~     days after the initial surgery is completed. Most patients with positive margins will~     undergo a second or even a third surgery to complete the tumor removal. The investigators~     hypothesize that the LUM Imaging System can reduce the rates of positive margins and, thus,~     the rates of second surgeries by identifying microscopic residual cancer in the tumor bed.~      This is a non-randomized, open label study to evaluate the safety and efficacy of an~     intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6~     Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer~     subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15~     total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be~     evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B~     and evaluate the device function. During Phase B, subjects will be injected with LUM015 at~     the dose determined during Phase A to preliminarily assess the performance of the detection~     algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard~     of care surgery and then use the LUM Imaging System to guide the removal of additional~     cavity shavings as indicated by the LUM Imaging System.~   "
47267|NCT02438345|"~     PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial~     of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO~     140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected~     injection drug users with viral rebound and documented poor adherence to the previous~     antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to~     receive an optimized background antiretroviral regimen (OBR) plus supervised weekly~     subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy~     variables will be obtained over the 24 week duration of the study. Safety will be monitored~     throughout the course of the study.~   "
47268|NCT02438332|"~     This study will evaluate the incidence of reoperations associated with the use of smooth and~     textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone~     primary breast augmentation.~   "
47269|NCT02438319|"~     Manually and automatically by mashing learning algorithm optic disc will be evaluated~     (planimetry).~   "
47270|NCT02438306|"~     This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control),~     sham-controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP~     cell therapy to a sham treatment.~      A roll-in phase with a maximum of 10 subjects will precede the randomised phase.~   "
47272|NCT02438280|"~     The AcceleDent® device has been introduced to the specialty of orthodontics in order to~     reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces~     (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth~     movement to occur more quickly.~      Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort~     during orthodontic treatment.~      This study will be a parallel group, triple-blind randomized clinical trial comparing two~     groups of subjects with 12 participants in each group. Subjects will be randomized to~     receive one of two vibrational units, which will differ in frequency and/or amplitude of~     vibration. The subjects will be asked to change their aligners every week instead of every 2~     weeks, which is common with Invisalign.~   "
47273|NCT02438267|"~     Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur~     in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born~     prematurely and with very low birth weight (<1500 gm) seem to be at the highest risk of~     developing NC. Recent changes in recommendations for nutrition for the preterm infant such~     as higher intakes of protein, calcium, and vitamin D may also play a factor in the~     pathogenesis of NC.~      Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other~     issues. Because there is no acute symptom or pattern of symptoms in the preterm population~     associated specifically with NC, it is possible that many cases of NC may not be diagnosed.~     Presently, it is impractical and costly to screen all infants for NC with renal ultrasound,~     therefore there is no standard of care regarding screening for NC.~      NC may have long-term effects. Studies have shown that preterm infants with NC had shorter~     kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants~     without NC.~      This study will analyze weekly urinalysis for all enrolled subjects prospectively and then~     look at the incidence of NC at discharge of the enrolled subjects.~   "
47274|NCT02438254|"~     The researchers are studying factors that may increase the risk for alcohol and drug use in~     individuals who do not have any problems with these substances. This study will be looking~     at health behaviors in young adults compared to their family's health behaviors and~     lifestyle.~      The investigators plan to study genetic differences in people with and without a family~     history of alcoholism. The researchers hope to learn how a family history of alcoholism,~     early life adversity and different genotypes shape personal characteristics associated with~     a risk for alcoholism.~   "
47275|NCT02438241|"~     Introduction: Pain is an important factor of increase of morbidity and mortality in patients~     undergoing surgical procedures include thoracotomy. There are different methods of analgesia~     in postoperative thoracic surgery, ranging from systemic analgesia with opioids, as well as~     local anesthetics block (intrapleural, extrapleural, intercostal cryoanalgesia, etc.) in~     addition to spinal blocks and Epidural blocks. In the pharmacological analgesia,~     electroanalgesia has been proposed as an adjunctive treatment for the relief of~     postoperative pain. Rationale: noting the lack of data in the literature regarding the use~     of this physical therapy technique in order to reduce the pain in the postoperative period~     of thoracic surgery and its consequences, it is relevant to the realization of a new~     randomized controlled trial (RCT) to evaluate the effects of transcutaneous electrical nerve~     (TENS) in the post - thoracic surgery on pain, pulmonary function and strength respiratory~     muscle. Objective: To evaluate the effects of TENS on pain, respiratory muscle strength and~     lung function in postoperative thoracic surgery in a Intensive Care Unit. Method: The~     subjects included will be randomized into three groups randomly: control group (CG) that~     will hold only conventional physical therapy, TENS group (EG) that will hold the application~     of TENS associated with conventional physical therapy, TENS placebo group (GP) who will~     perform the application of TENS placebo to conventional therapy. All groups carry out the~     assessments (digital manometer, spirometry, visual analog pain scale) in the preoperative~     period, postoperative Immediate / pre-intervention and at the end of treatment (discharge~     from the intensive care unit), except for the pain that will be evaluated before and after~     each intervention session. All patients receive physical therapy three times a day (morning,~     afternoon and evening) during hospitalization in the intensive care unit. Intervention: The~     conventional group will receive conventional therapy for hospital service. The TENS group~     will receive conventional therapy and the end of that service, will be applied TENS for 30~     minutes. The placebo TENS group will receive the conventional physical therapy and the end~     of the service will be installed TENS placebo, during this period the patient receives~     electrical stimulation for 45 seconds, shutting down at the end of this time and held~     position as TENS group.~   "
47276|NCT02438228|"~     The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by~     nine different pulse contour algorithms with transpulmonary thermodilution before and after~     cardiopulmonary bypass (CPB).~   "
47277|NCT02438215|"~     This is a single site, open-label study designed to examine dopamine transporter density~     using [123I]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day~     period in early Parkinson's disease patients. In addition, clinical evaluations will be~     performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of~     PD.~   "
47278|NCT02438202|"~     Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under~     general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific~     and severe psychiatric disorders) and extremely safe modern treatment option.~      Alzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by~     progressive cognitive deterioration accompanied by declining activities of daily living, by~     a variety of behavioral disturbances and by neuropsychiatric symptoms. The clinical~     progression of disease can be delayed by pharmaceutical therapies like acetylcholinesterase~     inhibition (e.g. rivastigmine) for 6 to 12 months at most.~      Along with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived~     neurotrophic factor (BDNF) level is since recently being considered as a negative predictor~     for the further disease course. In animal experimental studies it was possible to arrest the~     disease progression with the aid of neurotrophic substances. Many single studies, but also a~     number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and~     medial temporal brain regions.~      Strikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to~     an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists~     for gray matter volume gain after an ECT series, especially for the hippocampus.~      There is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on~     the basis of following indications: a) affective disorders and b) behavioral disturbances. A~     positive effect of ECT on the symptoms of agitation and aggression was assessed in AD~     patients alongside with a very good tolerability.~      To investigate the potential salutary effects of ECT on AD the investigators designed a~     pilot study with the following concept: Patients with a confirmed AD diagnosis and~     preexisting stable antidementia medication over at least 6 months will receive a modified~     maintenance ECT over a total of 27 weeks.~      In the proposed pilot study, the investigators hypothesize that cognitive functioning of AD~     patients will improve significantly and independently from affective symptoms, when initial~     and final examinations are compared. The affirmation of the hypothesis would provide not~     only further insight into the mechanism of action of ECT but also a very important reference~     point for the development of new treatment options for a so-far incurable disease.~   "
47288|NCT02438072|"~     We propose here to explore systematically the association between drug-metabolizing enzymes~     activity assessed by a phenotypical approach and antidepressant plasma concentration,~     efficacy and tolerance in the clinical setting. During one year, patients receiving~     antidepressant will be included in tis prospective clinical, naturalistic and descriptive~     pilot study.~   "
47289|NCT02438059|"~     The purpose of this study is to determine whether a web- and app-based tool for health~     promotion for social and health care workers in Denmark has an effect on body weight~     (primary outcome), body fat percentage, waist circumference, blood pressure, cholesterol and~     blood sugar in a 38 week intervention period.~   "
47279|NCT02438189|"~     Objective: to gain experience with in-home use of a modified algorithm that will dose~     insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if~     hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy~     data.~      Study Design: randomized controlled trial, with randomization on a night level within~     subject.~      Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for~     at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of~     age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of~     consciousness in last 6 months; Living with a significant other or family member~     (companion) committed to participating in all study activities, and being present and~     available to provide assistance when the system is being used at night.~      Sample Size: 30 subjects.~      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in~     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits~     at enrollment, following CGM and system assessment run-in phases, at start of clinical trial~     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system~     use.~      Major Efficacy Outcomes:~        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.~        -  Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in~          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.~      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood~     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and~     diabetic ketoacidosis.~   "
47280|NCT02438176|"~     The purpose of this study is to compare single groin puncture and bilateral groin puncture~     during AF ablation procedure. The investigators will compare 1) the degree of patients'~     discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and~     4) 1-year clinical recurrence rate of AF.~   "
47281|NCT02438163|"~     Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive~     Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures~     cerebral plasticity. Several parameters of cortical excitability are available for that~     purpose. These parameters are altered on patients wth MDD and these modifications are~     corrected after treatment. Therefore results in the studies are very heterogeneous. Theta~     Burst Stimulation (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can~     induce cerebral plasticity. The cerebral plasticity induced by TBS was measured on a group~     of patients suffering from Asperger's disease (ASD) versus a control group. The plasticity~     was significantly different in patients with ASD. The aim of our study is to study the~     neuroplasticity induced by TBS on a patients with MDD.~   "
47282|NCT02438150|"~     Objective: To investigate the effectiveness of an online training program on medical staff~     in five public hospitals located in Sichuan, Yunnan, Hubei, and Fujian Provinces of China,~     on improving fire knowledge.~      Methods: Participants will be randomly divided into control (receiving non-fire video~     training) and intervention (receiving hospital fire video training) groups. All participants~     will complete a questionnaire of fire knowledge before and after receiving the training.~      Hypothesis: If the online training is effective, it can be promoted as a convenient and~     effective use of training and be promoted to other hospitals.~   "
47283|NCT02438137|"~     The overall purpose of this study is to determine whether the oral medication dimethyl~     fumarate is an effective treatment for obstructive sleep apnea in patients who are unable,~     unwilling, or uneager to use positive airway pressure therapy.~   "
47284|NCT02438124|"~     The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait~     characteristics in Parkinson's disease (PD) are attested by clinical research.~      Nonetheless, it is still unclear which auditory information parameters (i.e. complexity,~     temporal regularity or adaptability to gait) maximize the effectiveness of RAS.~      Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait~     characteristics in PD patients with gait disorders according to:~        -  RAS complexity (i.e. metronome, amplitude modulated noise, music)~        -  RAS variability (i.e fixed, random, semi-random)~        -  RAS adapted in real-time to gait~      Variability study:~      To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients~     and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude~     noise and music.~      Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in~     real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait~     characteristics with metronome, amplitude noise and music.~   "
47285|NCT02438111|"~     The primary objective of this study is to assess whether compositional and functional~     alterations of the gut metagenome may be related to AMD. The primary variable for this~     assessment is the composition of the gut metagenome which will be analyzed by shotgun~     sequencing to characterize the faecal metagenome. The secondary endpoint is to assess~     whether single nucleotide polymorphisms in CFH, ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B,~     VEGFR and APOE genes which have been shown to be risk factors for the development of AMD and~     other macular diseases correlate with alterations in the gut metagenome .~   "
47286|NCT02438098|"~     Until now there ist no systematic investigation of the pharmacokinetic parameters of~     Rivaroxaban in obese patient undergoing bariatric surgery. The aim of this study is to~     investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban in obese~     patients before and after bariatric surgery.~      Patients receive the day before the surgical intervention the first dose of Rivaroxaban~     (10mg). During the following 24 hours, 9 blood samples are taken.~      The second tablet Rivaroxaban is administered on the third postoperative day, followed again~     by 9 blood samples during the next 24 hours.~      All other blood samples are taken independent from this clinical trial as part of the~     standard medical treatment during the hospitalization. The hospital stay will not be~     extended by the study. The outpatient regular follow-up takes place one month after surgery~     and is combined with the last study visit.~   "
47287|NCT02438085|"~     The ARYOSTO has been designed to describe the clinical epidemiology and the current~     management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors~     will evaluate the medical and interventional management of ACS patients admitted to~     hospitals in the area of Ferrara and receiving coronary artery angiography and percutaneous~     coronary intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria~     di Ferrara, Cona (FE), Italy)~   "
47310|NCT02437786|"~     The specific clinical trial is a part in which ALK- Abelló will directly work to explore~     human immunological mechanisms of SIT (observed after GRAZAX treatment).~   "
47290|NCT02438046|"~     In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the~     epithelialized connective tissue graft palatal donor site healing acceleration and in the~     patient's morbidity reduction. Forty patients, with at least one gingival recession will be~     treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from~     the de-epithelialization of a free gingival graft. In the test group (20 patients) a~     quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the~     control group patients will be treated by an absorbable gelatin sponge. Patients will be~     monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the~     palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the~     post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic~     scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed~     bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.~   "
47291|NCT02438033|"~     Deep brain stimulation for Parkinson's disease is a well established therapy. Current~     practice requires tedious adjustment of stimulation settings based on frequent patient~     assessments. Ultimately, the goal is to develop a system that can program itself using~     signals that are recorded directly from the brain on a continuous basis. Our previous work~     has identified abnormal electrical signals in the brain that are targeted for stimulation~     that can potentially be used to develop a self-programming system. In this study, the~     investigators will test the safety and utility of a novel adapted device that can not only~     deliver stimulation to the brain but also record brain signals in a patient that is~     implanted with a deep brain stimulation system. The purpose of this Phase I study is to~     understand the safety of the device as well as the relationship between these electrical~     signals measured from deep within the brain and Parkinson's symptoms and how these signals~     can be used to guide a self-programmed system. The study will entail implanting this special~     device (Activa PC+S) in place of the standard generator (Activa PC) and to compare clinical~     symptoms, recorded brain signals, and stimulation patterns during a one year period after~     implantation. Specifically, the investigators will use the Activa PC+S to record GPi~     (internal globus pallidus) local field potentials between and during programming visits,~     allowing the surgeon to better characterize a patient's disease. At the same time, the~     investigators will evaluate the safety of this new device.~   "
47292|NCT02438020|"~     Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis~     nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin~     is a useful drug for conditions characterized by insulin resistance.The aim of this study is~     to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as~     their effects on metabolic and anthropometric variables in a sample of obese children. This~     is a 12-week randomized, double-blind randomized trial involving obese children with AN to~     receive either metformin or placebo.~      Evaluations will be performed every three weeks. Clinical, histological and colorimetric~     assessments of AN lesions will be compared initially and at the conclusion of the study.~   "
47293|NCT02438007|"~     The purpose of this study is to compare galeterone to enzalutamide in men expressing~     androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant~     prostate cancer (CRPC).~   "
47294|NCT02437994|"~     Pulmonary rehabilitation is an essential non pharmacological treatment option which reduces~     dyspnea sensations, increase exercise tolerance, improves health related quality of life and~     reduces the burden on health care resources (1). Pulmonary rehabilitation is likely an ideal~     intervention to validate the PROactive tool as responses to pulmonary rehabilitation are~     clinically significant in terms of exercise tolerance and particularly activity related~     symptoms. Nevertheless, the response to pulmonary rehabilitation is variable and about one~     out of three patients does not present a clinically important response. Pulmonary~     rehabilitation may therefore be an intervention that allows studying the conceptual model~     around the PROactive tools, anchoring the new PROs (Patient Report Outcome) to outcomes that~     are well known to change with rehabilitation: exercise induced symptoms, functional exercise~     tolerance and health related quality of life.~      Study objectives~      Main objectives~      A primary aim is to test reliability of the paper-pencil versus the electronic scoring~     version of the PROactive tool in terms of assessing the effect of pulmonary rehabilitation~     on the components of the PROactive tool and on the mode of administration.~      The secondary aim of the proposed project is to investigate the effects of a~     multidisciplinary outpatient hospital-based, pulmonary rehabilitation program on: i) daily~     physical activity (number of daily steps, vector magnitude unit and movement intensity and~     ii) the components of the Proactive tool.~      Additional study objectives~      A third aim of this project is to investigate whether the magnitude of change in daily~     physical activity and the components of the PROactive tool in general is associated with the~     magnitude of changes in frequently used rehabilitation related end-points including,~     functional capacity, exercise capacity and health-related quality of life following the~     completion of a comprehensive pulmonary rehabilitation program.~      A forth aim of this project is to investigate whether the magnitude of change in daily~     physical activity and the components of the PROactive tool in general is associated with the~     magnitude of changes in physiological indices including cardiovascular and respiratory~     adaptations following completion of a comprehensive pulmonary rehabilitation program.~   "
47295|NCT02437981|"~     PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM~     and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded~     entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided~     part of a combined HIV prevention program that includes risk-reduction counseling, regular~     HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai~     Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center~     in Thailand.~   "
47296|NCT02437968|"~     The present study aims to test the implementation and sustainability of (a) a~     Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the~     BASC-2 TRS to identify anxious youth in the school setting using a cohort-sequential design~     (i.e., three years at 20 schools over the span of five years).~      'Camp Cope-A-Lot (Computer-assisted CBT program)'~   "
47319|NCT02437669|"~     Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It~     has not been previously studied in children, but may be a viable option for effectively and~     safely reducing pain in children by administering an analgesic by the intranasal route.~      This study will be a prospective, open-label pilot study of intranasal hydromorphone in~     children with moderate to severe acute pain presenting to the pediatric emergency~     department. The investigators aim to describe the amount of pain reduction associated with~     intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone~     associated with a clinically meaningful improvement in acute pain.~   "
47320|NCT02437656|"~     Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis.~     Historical cohort of patients with diabetes have shown that diabetics on Metformin had a~     better chance of survival than diabetics not on Metformin. These observations have led to in~     vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has~     anti-proliferative properties.~      The aim of our study is to evaluate the efficacy of metformin in combination with~     neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.~   "
47297|NCT02437955|"~     In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50~     months indicating that iron deficiency is a major health problem. The government of Senegal~     has implemented a flour fortification program including iron and folate. Iron is a difficult~     mineral to add to foods efficiently due to its organoleptic properties and typical low~     bioavailability in man. The aim of this study is to determine iron absorption from fortified~     wheat flour consumed with a phenolic containing beverage in women and child pairs. The~     fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption~     inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly~     investigated.~      The bioavailability of the different iron compounds will be determined using stable iron~     isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women~     between 18-45y) will be selected for participation in the study. After a screening, each~     women and child will receive 4 test meals consisting of a bread roll fortified stable~     isotopes with and without the tisane beverage. The first two test meals will be consumed on~     consecutive days. Two weeks after the second test meal a blood sample will be taken from~     each women and child before the third meal administration. After the forth test meal~     administration, and again two weeks later, the last blood sampling will take place and the~     study will be conducted for the subjects (duration 30 days). The samples will be sent to~     Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori~     infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as~     well as inflammation status (CRP) will be determined.~   "
47298|NCT02437942|"~     Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden~     et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a~     challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist~     in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw~     et al. 2008). This may be due to the complexity of the anatomy in the region and the absence~     of magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination.~      Dynamic actions undertaken in field sports (including change of direction cutting) are~     particularly associated with the development of athletic groin pain (Holmich et al. 2014).~     Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures~     in the hip and groin. Despite this, traditional groin pain assessments do not involve an~     examination of sport specific actions. An examination of jumping, hopping and cutting~     mechanics, which is possible with the use of three dimensional motion capture techniques,~     will provide additional information with which to diagnosis and rehabilitate athletes.~      While the majority of published studies on AGP have focused on surgical management (Serner~     et al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al.~     1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where~     subjects suffered for an average of 9.9 months with symptoms and a strength and stability~     program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper~     on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return~     to training of 86 days +/-15. The focus remains on improving strength of isolated muscle~     groups and not attempting to address underlying biomechanical abnormalities that may be~     leading to overload. Accurate biomechanical assessment and individualized rehabilitation~     based on the high speed multiplanar movements that drive the athlete's symptoms may enhance~     the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical~     factors may provide a further insight into the biomechanical factors associated with AGP.~      The purpose of this study was to:~        1. Describe clinical presentation (physical examination and magnetic resonance imaging~          findings) for a group of athletes presenting with AGP~        2. To describe the different biomechanical diagnoses that exist in AGP patients~        3. To examine the effects of a biomechanics led exercise intervention to rehabilitate~          chronic groin pain~      It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical~     diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct~     subgroups/clusters will exist that differ from each other in how they undertake dynamic~     sport specific actions. These distinct clusters will describe potential biomechanical~     diagnoses that exist in groin pain patients. A biomechanics led rehabilitation program will~     return groin pain patients back to sport more quickly than previous rehabilitation programs~     without biomechanical diagnostic information.~      Brief protocol Participants will be recruited from patients with chronic athletic groin pain~     who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A~     standardised clinical examination will be undertaken including range of motion assessment,~     pain provocation and load tolerance tests, and palpation.~      A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a~     consultant sports physician.~      Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics~     through the use of three dimensional motion capture technology and force plates. Here~     reflective markers are placed on the skin at anatomical landmarks. These markers are picked~     up by the cameras and tracked at 200 frames per second. Participants will contact the force~     plate with their foot on undertaking the movements. Force and marker data will be combined~     to calculate joint angles and moments.~      Physical therapy assessment will include an assessment of functional movement, range of~     motion testing, adductor squeeze tests, strength assessment of hip and trunk.~     Physiotherapists will utilise three dimensional biomechanical data during cutting and~     landing to inform individualised rehabilitation. Rehabilitation will consist of movement~     control, whole body strength and power, linear running mechanics, multi-directional~     mechanics and conditioning sessions. Participants will have follow up physical therapy~     appointments approximately every two weeks. A hip and groin outcome score (HAGOS) will be~     used to monitor the morbidity and severity of the injury throughout the rehabilitation~     process.~      Once the physiotherapist determines that the patient is ready to return to play a~     biomechanical re-test will be undertaken.~   "
47299|NCT02437929|"~     This study aims to assess self reported procedural pain compared with background pain and~     evaluate pain intensity differences across six standard procedures. Besides, rescue and~     preventive treatments used to control procedural pain will be examined.~   "
47300|NCT02437916|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity,~     and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.~   "
47301|NCT02437903|"~     This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the~     facial temporal regions based on the change in the score of the investigator's Temporal.~     This study will be an open label, single center study.~   "
47302|NCT02437890|"~     Primary objective:~      To assess the efficacy and safety of different dose regimens of ALX-0061 administered~     subcutaneously (s.c.) to subjects with moderate to severe active, seropositive SLE compared~     to placebo.~      Secondary objectives:~      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,~     steroid reduction and health-related quality of life, with different dose regimens of~     ALX-0061.~   "
47303|NCT02437877|"~     Purpose: To examine whether nasal breathing influences the perception of sound causing trade~     between hard and soft consonants in the writing of children in school age and the incidence~     of trade.~   "
47304|NCT02437864|"~     Airway placement after anesthetic induction in pediatric patients is routinely performed at~     our institution without apneic oxygenation. When intubation is attempted by an inexperienced~     (learner) provider, the attending physician intervenes if necessary before the patient~     experiences excessive loss of oxygenation. The investigators plan to institute routine~     supplemental oxygenation via nasal cannula during this placement. This study will examine~     the effect of adding apneic oxygenation via nasal cannula on oxygen saturation.~   "
47305|NCT02437851|"~     This phase II trial studies surgery in treating patients with anal canal or perianal cancer~     that is small and has not spread deeply into the tissues and human immunodeficiency virus~     (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger~     surgery or radiation and chemotherapy.~   "
47306|NCT02437838|"~     The primary objectives of this study are to examine whether augmented renal clearance (ARC)~     compromises renally eliminated drug therapeutic serum concentrations in patients with~     traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic~     serum concentrations of the probe medication levetiracetam in patients with TBI.~   "
47307|NCT02437825|"~     Salivary fistulae have been the bane of surgical salvage in the era of primary~     chemoradiation for head and neck (H&N) cancers. The blameof prior chemoradiation tissue~     damage encouraged compensatory surgical techniques that focused on the insertion of~     non-irradiated tissue into the field. This study emphasizes a paradigm shift in the~     understanding and treatment of pharyngocutaneous fistulae. The detrimental effects of~     salivary enzymes on tissue healing and surgical anastomoses are addressed and novel~     treatment strategy is outlined.~   "
47308|NCT02437812|"~     Initially, the prospect of metformin as a neoplastic treatment was considered for~     malignancies of the prostate, colon and pancreas. However, only select clinical studies~     involving the use of metformin in the treatment of ovarian cancer have documented improved~     survival rates. Since no first line regimen has demonstrated compelling superiority in the~     management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin,~     and metformin is of particular interest given the triplet's prospect for achieving increased~     synergy without compromising patient tolerability.~   "
47309|NCT02437799|"~     BACKGROUND:~      Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result~     in detrimental effects to the mother and foetus. A previous pilot study where images of the~     pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the~     systolic wave during the onset of hypotension.~      AIMS:~      The investigators wish to download electronic data which describe the pulse oximeter pulse~     wave to more accurately assess movement of the diastolic wave relative to the systolic wave~     during spinal anaesthesia for caesarean section.~      METHODOLOGY:~      20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed~     consent for this observational study. Data downloaded from the pulse oximeter will be~     analysed to identify movement of the dicrotic wave relative to the systolic wave and this~     will be related to changes in blood pressure.~      EXPECTED OUTCOMES:~      The investigators will establish best way to analyse changes in the pulse oximeter waveform~     and the relationship between changes in pulse oximeter waveform morphology and the onset of~     hypotension during spinal anaesthesia for caesarean section.~      IMPLICATIONS:~      Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe~     hypotension during spinal anaesthesia for caesarean section.~   "
47311|NCT02437773|"~     Obsessive-compulsive disorder (OCD), characterized by intrusive thoughts (obsessions) and~     related behavioral rituals (compulsions), is a common psychiatric illness that often emerges~     in childhood and causes life-long disability in over 50% of patients. Psychological theory~     suggests that OCD symptoms are driven by a person's difficulty disengaging their feelings~     from simple tasks (e.g. washing hands, locking a door) due to excessive anxiety about~     performance errors. Cognitive behavioral therapy (CBT), the gold standard treatment for OCD,~     repeatedly exposes patients to their OCD-stressor until this anxiety is reduced. While CBT~     is typically more effective in teenagers than adults, patients from both age groups are~     usually left with residual symptoms, highlighting the need for better treatments. In this~     study, CBT will be studied in both teen-aged and adult patients. Two groups, both with~     childhood onset OCD, will be randomized to either CBT for OCD or stress management training~     (SMT), an active therapy but with minimal effects on OCD symptoms. The investigators will~     also study age-matched, healthy controls as comparison subjects.~      Before and after 12 weeks of CBT, all subjects will undergo functional Magnetic Resonance~     Imaging (fMRI) scans to see what regions of the brain become active when a concentration~     task is performed and how that activation is changed after CBT. The purpose of this study is~     to demonstrate the brain changes associated with CBT treatment and how differences in these~     changes in teenage compared to adult patients may drive differences in CBT response.~   "
47312|NCT02437760|"~     The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well~     defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer,~     including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at~     advanced stage. Malignant pleural effusion secondary to lung cancer represented the~     condition of cancer cell involved pleura.~      The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could~     be correlated with the prognosis. This study was performed to examine the properties of~     CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant~     pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary~     therapy as a surrogate indicator for survival.~   "
47313|NCT02437747|"~     A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root~     planing in the treatment of chronic periodontitis patients with controlled type II diabetes~     mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative~     Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline~     and 3 months.~   "
47314|NCT02437734|"~     Disease in coronary arteries kills more people in the UK than any other cause. The~     investigators have developed a computer system ('VIRTU') which predicts blood pressure~     changes inside coronary arteries. This is important because;~        -  Doctors make better decisions regarding when and how to treat patients with coronary~          artery disease if they have these blood pressure measurements~        -  Currently, Doctors have to insert a metal wire inside the heart to measure artery~          pressures which is time-consuming and requires special equipment, staff, training and~          medicines.~      Although this invasive technique saves lives and money, more than 95% of patients do not~     receive the procedure or the benefits it provides.~      VIRTU provides a solution to this problem since it only needs X-ray pictures and does not~     require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and~     works but needs improving before it can be used in all patients.~      GOALS:~      Following, and compared with, our pilot project ((Modelling the significance of coronary~     artery disease, STH 15740) to:~        1. Improve VIRTU's accuracy.~        2. Improve VIRTU's speed.~        3. Test VIRTU in patients with more complicated coronary disease.~      One hundred patients will be recruited from angiography waiting lists and consented before~     attending for their angiography. The patients will be asked whether their angiogram pictures~     and pressure measurements maybe used as part of the data collection for this study. The data~     will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver~     all the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and~     cost) but, is less invasive and usable in 100% patients.~   "
47315|NCT02437721|"~     The study is designed to show equivalence of an infant formula containing L-5-~     Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in~     respect to weight gain of healthy term infants receiving these infant formulae exclusively~     during the first 4 months of life. Healthy non breast fed infants will be randomized to~     receive either a standard infant formula with folic acid or a corresponding formula with~     MTHF instead of folic acid. Besides weight and length further anthropometric measures will~     be taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16~     weeks blood samples will be taken for the determination of folate status and genotyping. As~     a reference the same measures will be taken in a group of breast fed infants, whose mothers`~     folate status will be determined as well.~   "
47316|NCT02437708|"~     This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF)~     on the periapical bone healing and further root development of infected immature permanent~     teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as~     scaffold, in the control group REP without L-PRF is performed .~   "
47317|NCT02437695|"~     Although a condition for surgery, robotic interventions applied with steep~     Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral~     neuropathy if good position is not achieved on the operating table. This study will be a~     7-year retrospective examination of postoperative positional injury (PPI) in patients~     undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.~   "
47318|NCT02437682|"~     The PASS test is only available and valid tool for the evaluation of persistent acid-related~     symptoms in patients receiving PPI therapy. There is lack of a validated Chines version of~     PASS questionnaire for the GERD patients with partial response to proton pump inhibitor~     (PPI). The English version of PASS test will be translated to traditional Chinese by using~     forward-backward procedure, and the Chinese version of PASS test will be validated its~     psychometric properties in Hong Kong population.~      Eligible subjects will be invited to administer questionnaires to evaluate the psychometric~     properties of the Chinese version of PASS test.~   "
47353|NCT02437227|"~     The study is a first in man, dose escalation study to evaluate the safety, tolerability and~     how the drug works in the body in patients with all solid tumours. The aim of this study is~     to determine the most effective dose of the study drug that can then be further investigated~     in patients with advanced melanoma.~   "
47322|NCT02437630|"~     In this study the investigators aim to investigate the extent to which in patients with~     chronic obstructive pulmonary disease narrowing of the vocal cords causes a positive~     pressure within the airways thus improving airflow and lung function. This information will~     be captured in the upright and lying down positions and an estimate of the magnitude of the~     effect will be formed by offsetting the pressure by asking the patients to breathe using a~     commercially available device used to treat sleep apnoea called a CPAP machine. This is an~     observational study in which the observation of laryngeal aperture, and mouth and~     oesophageal pressure at differing levels of applied CPAP will be recorded for analysis in~     patients with COPD and in normal subjects without COPD. All will have the same measurements,~     observations, and interventions to allow us to observe and measure pressure, laryngeal~     aperture, and airflow .~   "
47323|NCT02437617|"~     The goal of this research study is to collect and test tumor tissue from patients with~     advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers~     will study if the results from genetic testing can help researchers determine which therapy~     may prove more beneficial for a patient in the future.~   "
47324|NCT02437604|"~     Each patient will participate in the study for approximately 7 weeks. Participation will~     include a screening period of up to 21 days and 4 treatment periods; each consisting of a~     3-day/2-night inpatient period.~   "
47325|NCT02437591|"~     The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin~     (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and~     C. difficile Infection (CDI).~      This study will also compare CDI clinical response to the microbiological response in terms~     of magnitude of reduction of C. difficile total viable count and spore count during~     treatment with FDX and if achieved; the time to microbial eradication; determine time to~     negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool~     concentrations of FDX and metabolite OP-1118 throughout therapy; record the incidence and~     severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as~     measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.~   "
47326|NCT02437578|"~     Today, it is evident that vitamin D has more widespread effects than the classical actions~     related to bone mineralization and calcium homeostasis. Vitamin D deficiency results in~     impaired reproductive performance in various species of animals, and recently the~     investigators have shown that the Vitamin D receptor (VDR), activating (CYP2R1, CYP27A1,~     CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis,~     seminal vesicle, prostate and spermatozoa. Functional studies showed that activated vitamin~     D increases intracellular calcium and sperm motility in mature spermatozoa, and hence may be~     important not only for spermatogenesis but also for sperm function. Any test that might~     assist in guiding the treatment of the infertile couple would be beneficial both for most~     infertile couples and the society in general. The fact that vitamin D may play a role for~     human semen quality are now being tested clinically. If vitamin D supplementation proves~     efficient this opens for the first time for a causal, safe and cheap treatment of at least~     some cases of idiopathic impaired semen quality. This may also have consequences in the in~     vitro setting as activated vitamin D may be used to select high quality sperm during~     assisted reproductive techniques. The presence of the vitamin D receptor and vitamin D~     metabolizing enzyme CYP24A1 in particular is able to discriminate spermatozoa from normal~     and infertile men. CYP24A1 is expressed at the annulus of normal sperm, but it is virtually~     absent from spermatozoa from infertile men. This indicates that CYP24A1 expression may~     assist in predicting the chance of success by using insemination (IUI), IVF or ICSI. CYP24A1~     expression is induced by activated vitamin D, which indicates that other VDR activated genes~     also may serve as positive predictive markers of fertility. In addition, vitamin D~     metabolites and other factors in the female reproductive tract will be measured to determine~     if they alone or in combination with other markers can determine whether the best solution~     for the infertile couple would be to do IUI, IVF, or ICSI. The suggested clinical trial may~     therefore be able to evaluate several secondary endpoints in addition to CYP24A1 in our~     search for predictive markers for fertilization. For instance several biomarkers in serum,~     seminal plasma or follicular fluid in conjunction with genetic polymorphisms in several~     genes important for reproductive function.~   "
47327|NCT02437565|"~     Stainless steel crowns are arguably the most successful posterior restorations in primary~     teeth and have been so for more than 50 years. Stainless steel crowns offer durability and~     success rates in excess of 95% making them the restoration of choice for posterior primary~     teeth in children treated under general anesthesia.~      Failures of stainless steel crowns placed on primary teeth have been documented using~     several criteria including marginal adaptation, recurrent caries, abscess formation or root~     resorption, loss of the crown due to faulty retention and even perforation of the crown .~     Despite the probability that factors such as root resorption and failure of endodontic~     treatment could be due to traumatic occlusion, surprisingly little evidence is available in~     literature on the attempts made to check or evaluate the occlusion of stainless steel crowns~     placed under general anesthesia The aim of this study was to compare the time taken for~     placement and the overall success of bilateral multiple stainless crowns placed under~     general anesthesia using an occlusal index and compare them to crowns placed without such an~     index, using a randomized control study design~   "
47328|NCT02437552|"~     The prevalence of heart diseases has increased significantly in recent years and it is a~     health public problem due to an increased risk of death by several reasons. A cardiac~     surgery is an alternative of treatment for critical injuries heart valves and coronaries~     arteries. Changes in respiratory system resulting from cardiac surgery are well established~     and include a reduced functional capacity due post-surgical pain, causing increased~     respiratory function and increased oxygen consumption . The exercises with the cycle~     ergometer in phase I of cardiac rehabilitation can improve peripheral muscle strength,~     functional capacity and perception of dyspnea when used postoperatively and there are~     speculations if an earlier carried out can contribute to a better postoperative evolution of~     patients, but these benefits in phase I of the Rehabilitation Cardiac are not well defined~     in the literature. Objective: To evaluate the exercises effects with ergometer cycle in the~     postoperative course of patients undergoing cardiac surgery. Method: Patients will be~     recruited the cardiac surgery service of Polyclinic Pato Branco in the city of Pato Branco~     in state of Paraná, of both sexes, appropriate for the inclusion criteria, which will be~     evaluated by pulmonary function tests (strength of respiratory muscles, submaximal exercise~     test, dyspnea scales, laboratories tests and radiological exam). All patients will be~     randomly assigned for one of two groups: the control group (Conventional treatment) and~     rehabilitation group (conventional treatment +cycle ergometer), for about 7 days at~     postoperative period. Patients will be reevaluated on the third postoperative day and at~     discharge. Clinical evolution data will be collected from the records and notes of the~     medical staff and monitoring physiotherapist.~   "
47354|NCT02437214|"~     A single blinded controlled trial to determine if an intervention of listening to nursery~     songs with integrated heart beat sounds results in changes in anxiety level in infants and~     young children less than four years of age in an emergent setting.~   "
47329|NCT02437539|"~     The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for~     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential~     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and~     less aggressive tumors. This is a first in human study to test the radiotracer in cancer~     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10~     minutes, 1 hour and 2 hours post injection).~   "
47330|NCT02437526|"~     This study is designed to determine if individual patients with HIV infection have been~     cured of the infection. To do this, antiretroviral therapy is discontinued under close~     medical supervision and the patient monitored over time for reactivation of infection.~   "
47331|NCT02437513|"~     Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy~     (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences~     of aspiration and respiratory tract complications such as aspiration pneumonia. Current~     standard of care treatment to reduce the consequences of aspiration is often a tracheostomy~     which has its own risks and complications. The proposed study aims to describe the~     performance of a new CE marked medical implant, the NewBreez, in protecting the patient's~     airways from aspiration.~   "
47332|NCT02437500|"~     This is an open-label study for patients who have a recurrence of Clostridium difficile~     infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004~     study has completed enrollment, SERES-005 was amended to allow expanded access in accordance~     with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for~     the SERES-004 study.~   "
47333|NCT02437487|"~     The study will involve administering the study drug as a single dose of study drug or~     placebo. This study is designed to demonstrate the superiority of the experimental drug~     versus placebo in adult patients with recurrent CDI.~   "
47334|NCT02437474|"~     The purposes of this study are~        -  to test the hypothesis that elimination or reduction of dietary animal proteins leads~          to an improved prognosis in tumor patients~        -  to estimate the effect size and thus to enable sample size calculations for further~          studies~        -  to test the feasibility and tolerance of different diets, especially a vegan diet, in~          cancer patients and to proof that a vegan diet does not lead to a deterioration of~          health, tumor progression or to malnutrition~        -  to test the online platform as a study platform~        -  to test validity of self reported and online generated data~   "
47335|NCT02437461|"~     This prospective randomised controlled single blind trial comparing the relapse rate in 6~     months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for~     knee synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is~     performed to find the optimal dose to use.~   "
47336|NCT02437448|"~     The aim of the study is to answer the question whether a disease specific profile of breath~     in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study~     using exhaled breath analysis by mass spectrometry.~   "
47337|NCT02437435|"~     Ivanovski shows that by studying the vascular impedance can calculate the optimal uterine~     receptivity in IVF. A reduced vascular resistance and increased blood flow rate improves the~     chance of pregnancy.~      Dr. Luis T. Mercé says: After evaluating 40 cycles of IVF (In Vitro Fertilization) have~     found that the pregnancy rates increases with increasing endometrial volume. It has also~     advocated that the endometrial blood flow better reflects uterine receptivity, since the~     endometrium is where will take place the embryo implantation. Merce also claims to have~     found that the pregnancy rate increases with increasing endometrial volume and no~     pregnancies were achieved with endometrial volume less than 3 ml.~      These statements motivate us to perform a research project to monitor changes that occur in~     the uterine endometrial vascularization and subendomertial vascularization after applying a~     manual physiotherapic technique in menopausal women.~      Various authors report that by osteopathic techniques applied on visceral structures,~     vascular flow rate of the treated bodies increased.~      In the literature there are not articles on the subject at hand, but there are references to~     the manual techniques in the treatment of women with infertility where they state that the~     manual action for lymphatic congestion in the pelvic region facilitates pregnancy in women~     infertile.~      The practice of visceral osteopathy offers the possibility of accessing the treatment of~     uterine functional disorders, as well as structures such as uterine ligaments. They~     influence the fluidic efficiency of uterine arteriovenous system. According to Salamon E.,~     W. Zhu and Stefano GB., provides enough tools to improve the movement of fluids and uterine~     vascularization.~   "
47338|NCT02437422|"~     A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact~     on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease~     (ESRD).~   "
47339|NCT02437409|"~     ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox~     GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when~     using the pREset to treat acute occlusions of cerebral vessels will be analyzed.~      *German: Gesellschaft mit beschränkter Haftung, limited liability company~   "
47340|NCT02437396|"~     The objective of this study is to evaluate oxidative stress and/or inflammation in patients~     with Gaucher disease type I using a series of biomarkers and correlate with measurements of~     currently used diagnostic biomarkers.~   "
47355|NCT02437201|"~     Previous studies indicated high frequency of abuse in families and its consequences.~     Considering the importance of interventions such as educational interventions, in order to~     increase women's abilities to prevent abusive behaviors, the current research aims to~     determine the impact of an Liberty program on prevention of violence against women and~     propose solutions for less damages and consequences.~   "
47382|NCT02436850|"~     The purpose of the trial is to evaluate the effectiveness of moderate to large volume~     thoracentesis (TC) in non-ventilated patients in Internal Medicine admitted due to, or~     suffer from respiratory instability. This is a prospective, double-center, randomized~     clinical trial. This is a stage 1 pilot trial aimed to provide better understanding on the~     study population and study groups. This trial will comprise a total of 60 patients, 30~     subjects on the intervention group and an equal number on the control group. The results of~     this pilot trial will be to design a larger trial and calculate a required sample size.~   "
47341|NCT02437383|"~     Purpose:~      Primary: To evaluate the efficacy of extended-release propranolol compared to placebo for~     reducing pain in patients with temporomandibular disorder (TMD).~      Secondary: To determine if extended-release propranolol efficacy varies according to~     participants' catechol-O-methyltransferase (COMT) genetic diplotype.~      Exploratory: To investigate whether the effect of extended-release propranolol on the~     incidence of adverse effects, use of rescue medication, or pain index varies according to~     polymorphisms in the noncoding regions of COMT, adrenergic receptor β2 (ADRβ2), or~     adrenergic receptor β3 (ADRβ3) genes.~      Participants:~      200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind~     fashion, to receive either extended-release propranolol or placebo at one of three study~     sites: University of North Carolina-Chapel Hill School of Dentistry; University of~     Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo~     School of Dental Medicine.~      Procedures (methods):~      Randomization will be to either propranolol or placebo. The 10-week study treatment period~     is divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug~     tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the~     maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits~     over 12-15 weeks as follows: screening and baseline visit (Visit [V] 0, 7-21 days prior to~     V1); randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2~     (V2, 1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks~     post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization,~     study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after~     drug tapering ends, study day 77 +/- 7). Depending on the visit, procedures will include:~     reviews of medical history, weekly alcohol consumption, concomitant therapies and~     medications, adverse events, compliance, and eligibility; administration/review of~     questionnaires; blood draw; pregnancy test in women of childbearing potential; and~     dispensing of study drug.~   "
47342|NCT02437370|"~     This phase I trial studies the side effects and best dose of pembrolizumab when given~     together with docetaxel or gemcitabine hydrochloride in treating patients with previously~     treated urothelial cancer that has spread to other places in the body and usually cannot be~     cured or controlled with treatment (advanced) or that has spread from the primary site~     (place where it started) to other places in the body (metastatic). Monoclonal antibodies,~     such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.~     Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving pembrolizumab together with~     docetaxel or gemcitabine hydrochloride may be a better treatment for urothelial cancer.~   "
47343|NCT02437357|"~     The purpose of the present randomized-controlled trial is to investigate the efficacy of~     Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group~     intervention.~   "
47344|NCT02437344|"~     Opioid dependence is a substantial problem associated with significant morbidity and~     mortality. Extended-release naltrexone has been found effective at reducing opioid use and~     maintaining abstinence, but its use has been limited by the difficulties encountered with~     treatment initiation, which involves detoxification from opioids and oral naltrexone~     titration. Improving the likelihood of a successful transition to naltrexone is therefore an~     important public health goal.~      N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and~     symptoms of withdrawal from opioids, as well as to address adaptations associated with~     chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These~     benefits may persist for at least 72 hours after a single dose. NMDA antagonism may~     therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving~     motivation, and ameliorating adaptations associated with drug dependence, such as craving~     and arousal.~      The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted~     naltrexone initiation in opioid dependent individuals. After administration of~     extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to~     appropriate care subsequently (oral naltrexone, extended-release naltrexone).~   "
47345|NCT02437331|"~     The purpose of this study is to explore the experience in being with advanced Heart failure~     patients.~   "
47346|NCT02437318|"~     To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free~     survival compared to fulvestrant and placebo in men and postmenopausal women with hormone~     receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment~     with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.~   "
47347|NCT02437305|"~     This study will examine the effectiveness of a targeted, health literate educational~     intervention for people of color compared to a standard melanoma education pamphlet for~     increasing knowledge and promoting early melanoma detection. It is hypothesized that people~     of color are less aware of their risk for developing melanoma and that a targeted~     educational intervention will help increase knowledge and promote early melanoma detection~     especially in individuals with low health literacy.~   "
47348|NCT02437292|"~     The purpose of this study is to determine the effect of ischemic compression with stretching~     on pain related parameters including pain intensity, pressure pain threshold, anxiety,~     cervical range of motion and patient satisfaction in patients with scapular pain associated~     with myofascial trigger point.~   "
47349|NCT02437279|"~     This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the~     combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.~   "
47350|NCT02437266|"~     The purpose of this study is to determine the effect of scapular mobilization on pain~     related parameters including pain intensity, pressure pain threshold, muscle tension,~     anxiety, Scapular range of motion, patient satisfaction in patients with scapular pain~     associated with myofascial trigger point:~   "
47351|NCT02437253|"~     The purpose of the study is to collect preliminary data on whether the drug adalimumab (also~     called Humira) can decrease pain and stiffness, improve quality of life, and is safe in~     people with mucopolysaccharidosis type I, II, or VI. In this study people will be randomly~     assigned to one of two groups. One group will be treated with adalimumab the first 16 weeks~     of the study and then with a saline injection for the last 16 weeks of the study. The other~     group will start with the saline injection for 16 weeks and then switch to adalimumab for~     the last 16 weeks. The study subject and the study doctor and study coordinator will not~     know what group a subject is in until the study is done. Adalimumab is given as an~     injection, just under the skin, every 2 weeks. Both groups will have blood drawn at a~     screening visit, and then 7 more times over the 32 week study. There will be safety labs~     done (liver and immune function tests). Other safety tests include a chest X-ray and~     screening for tuberculosis exposure - these will be done at the screening visit and later in~     the study if there is concern for tuberculosis exposure or a persistent cough. The following~     will also be done at screening, the first, middle, and last study visits: 1) a pregnancy~     test in all girls 8 and older, 2) questionnaires that ask about pain, how MPS impacts social~     and physical function, and other quality of life questions, 3) height and weight. Finally, a~     physical exam, that includes for children and adolescents a check of where they are in~     puberty, will be done by a study physician at the first, middle, and last visits. There are~     risks to taking adalimumab that include redness and pain where the injection is given, a~     decreased ability to fight off infections, and others. The safety tests are designed to~     identify and decrease the risk associated with adalimumab. The study physicians believe that~     the potential benefit of adalimumab on pain, quality of life, and other MPS related problems~     outweigh the potential risks of treatment.~   "
47352|NCT02437240|"~     The purpose of this clinical trial is to evaluate the effect of pilates-based~     cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.~   "
47356|NCT02437188|"~     A large number of veterans suffer from distress-based conditions, such as anxiety and~     depression, putting them at high risk of experiencing persistent pain and prolonged opioid~     use following surgery. These connections are based on strong and consistent evidence from~     the literature and our preliminary data. The proposed study adds a 1-day workshop of~     Acceptance and Commitment Therapy (ACT), followed by an individual booster session, to~     treatment as usual (TAU) to reduce veterans' risk of persistent pain and prolonged opioid~     use following surgery. ACT has been shown to be effective in reducing chronic pain, anxiety~     and depression.~      This pilot study will establish the feasibility and preliminary efficacy of incorporating~     ACT into treatment as usual (TAU) to preoperatively target distress-based risk factors. Aim~     1 is to establish the feasibility of successfully delivering ACT to at-risk veterans before~     and after surgery. Aim 2 is to test the preliminary efficacy of ACT on the length and/or~     amount of pain and opioid use after surgery. Veterans who are anxious or depressed before~     surgery will be randomly assigned to receive ACT plus TAU or TAU. Outcomes between the two~     groups will be compared. Aim 3 is to see if PROMIS modules, developed by the National~     Institute of Health, are useful for assessing pain and other symptoms in veterans. Findings~     from this study will be used to inform the design and implementation of a larger, well~     controlled, randomized clinical trial that will evaluate the efficacy of ACT plus TAU for~     at-risk veterans.~      This study will take place at the Iowa City VA Health Care System (VAMC). Veterans scheduled~     for orthopedic or open abdominal surgery in 1 to 3 months who score high for anxiety or~     depression will be randomly assigned to attend a 1-day ACT workshop preoperatively, with an~     individualize booster session postoperatively, or to have TAU. Veterans who receive ACT~     and trainers who provide the treatment will be interviewed to identify barriers and~     facilitators to providing ACT to at-risk veterans before and after surgery. Other primarily~     outcomes are pain and opioid use after surgery. Factors that may affect these outcomes will~     also be measured, including anxiety, depression, substance use disorder, post-traumatic~     stress disorder, and use of other pain meds.~      The investigators expect to gain important knowledge about ways to best include ACT as part~     of routine care for veterans requiring surgery and about the preliminary efficacy of ACT for~     the prevention of persistent pain and prolonged opioid use following surgery.~   "
47357|NCT02437175|"~     The primary objective of this pilot study is to evaluate the efficacy of trace elements,~     versus placebo, on the reduction of pain in endometriosis of an American Fertility Society~     (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4~     months.~   "
47358|NCT02437162|"~     The purpose of this study is to assess the efficacy of ustekinumab, in adult participants~     with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha~     agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.~   "
47359|NCT02437149|"~     The study will measure the effectiveness of a distracted driving campaign in the emergency~     department in teenagers, 15 to 18 years old, to determine if it changes their attitudes~     towards texting while driving. It will also assess previous knowledge and behaviors in this~     age group, regarding distracted driving and what educational tool (power point vs. videos~     vs. brochure) has the most impact changing the attitudes towards texting and driving.~   "
47360|NCT02437136|"~     The purpose of this study is to determine the safety and tolerability of entinostat used in~     combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the~     purpose of the study is to assess how effective entinostat and pembrolizumab are in~     combination in patients with Non-small Cell Lung Cancer and Melanoma.~   "
47361|NCT02437123|"~     This study will examine the effect of a culturally-safe two-way supportive text message~     intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs~     in a community-based setting.~      The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and~     Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and~     Prince George, British Columbia, Canada. Indigenous collaborators and investigators,~     collectively known as the Cedar Project Partnership, govern the entire research process.~      A stratified Zelen pre-randomized design will be used to identify a random selection of~     cohort members to be offered the Cedar Project mHealth intervention with consent.~     Participants in the intervention arm will receive a package of supports, including a mobile~     phone and long-distance plan, weekly two-way supportive text messaging via the WelTel~     platform, and support from Cedar Advocates. Those drawn from the cohort study population as~     the comparison group will continue on in the usual Cedar Project study under its existing~     informed consent with no change whatsoever to their participation in the overall study.~      The main outcome is an HIV propensity score, assessed at six months and one year. Secondary~     outcomes include HIV risk, resilience, access to drug-related services, psychological~     distress, and connection to culture measured at six months and one year. Primary analysis is~     by intention to treat.~   "
47362|NCT02437110|"~     Background:~      - Some people with Amyotrophic Lateral Sclerosis (ALS) have a high level of the virus HERV-K~     in their blood. Researchers do not think this virus causes ALS. But they don t know why some~     people with ALS have a high level of it. They want to know if HERV-K can be suppressed by~     drugs that are used to treat HIV infection.~      Objectives:~      - To learn how drugs usually taken for HIV infection affect people with Amyotrophic Lateral~     Sclerosis (ALS).~      Eligibility:~      - Adults at least 18 years old with ALS and high levels of HERV-K but no HIV.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and~          breathing tests.~        -  Visit 2: participants will have medical history, questionnaires, and blood drawn. Their~          strength will be tested by pushing on a machine. They will blow into a tube that~          measures the air they can hold in their lungs.~        -  After Visit 2, participants will start taking the 4 study drugs twice a day.~        -  Participants will have study visits at Weeks 1, 2, and 4, then every 4 weeks until Week~          36. They will be asked how they are feeling and have an exam and blood drawn. At 2~          visits, they will have tests of strength, breathing, and their ALS symptoms. Some~          visits may be done at their ALS doctor s office.~        -  At Week 24, they will stop taking the study drugs.~        -  After the Week 36 visit, their participation is finished.~   "
47369|NCT02437019|"~     The purpose of this study is to provide early access to Ibrutinib treatment for participants~     with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety~     data while the medication is not commercially available.~   "
47370|NCT02437006|"~     This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are~     recruited, and they are assessed and recorded with clinical characteristics, sympathetic~     nerve testing, and twice symptom-limit exercise capacity tests. The second stage would~     recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three~     groups (control, low-intensity, high-intensity). They are evaluated before and after the~     four-week interval with clinical characteristics and twice symptom-limit exercise capacity~     tests (baseline and after four-week training) .~   "
47371|NCT02436993|"~     The purpose of this phase II is to study the efficacy and toxicity of carboplatin and~     paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel~     with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast~     cancer.~   "
47405|NCT02436551|"~     Evaluate prevalence and management of gestational diabetes in Tajikistan in two different~     settings (one rural and one urban).~   "
47363|NCT02437097|"~     Many studies have examined the effects of aerobic exercise and playing video games effects~     on cognitive performance, which results of which have shown to increase cognitive~     performance. Presently, there is limited research regarding the effects of the combination~     of gaming and exercise on cognitive performance. The purpose of our study is to investigate~     the effects of playing video games, aerobic exercise, and a combination of gaming and~     aerobic exercise on cognitive performance. Forty healthy subjects, males and females (18-30~     years old) who perform moderate exercise at least two times a week will comprise our sample.~     The study will be a randomized clinical trial with four independent variables: playing video~     games, aerobic exercise, a combination of simultaneous gaming and aerobic exercise and a~     control condition. Aerobic exercise will be performed at an intensity of 60 to 70% of~     maximum heart rate on a Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in~     Minutes a Day! will be played on Nintendo 3DS. Executive function will be measured using the~     Stroop test and Trails B pre and posttest. Analysis of variance for Stroop test and Trails B~     will be used. In the event of significant F statistics, a post hoc test analysis will be~     used. The investigators hypothesize a combination of aerobic exercise and simultaneous~     gaming will produce the greatest increase in cognitive performance. Furthermore, these~     beneficial changes can be utilized in rehabilitation protocols designed to improve cognitive~     functioning.~   "
47364|NCT02437084|"~     There is general agreement that statin-treatment of patients with high cholesterol can~     increase the incidence of type 2 diabetes (T2DM) in some individuals. This research proposal~     will study what metabolic characteristics and variables (for example high cholesterol or~     high triglycerides or both) will identify those people at highest risk of statin-induced~     T2DM. The investigators will evaluate how the medication atorvastatin (trade name Lipitor)~     works in regards to its effect on insulin action and insulin sensitivity to help further~     understand the possible cause of the increased occurrences of T2DM in people who are at risk~     for T2DM.~      Under Dr. Snyder, a Co-director of the study, samples will be collected for integrated~     Personal Omics Profiling (iPOP), a monitoring approach developed by Dr. Snyder and his~     research colleagues. The investigators propose to analyze iPOP of individuals who~     participate in this study during and after taking the statin. In this pilot study, analysis~     will be done on previously-known drug effectiveness but also untargeted drug's~     effectiveness, (other unknown benefits this medication may have) and drug effects such as~     those seen in some participants when given a statin. The hope then is to obtain a better~     understanding of how to perform a personal omics profile when taking drugs, which would lead~     to develop better use of drugs.~   "
47365|NCT02437071|"~     The radiation therapy or ablation that the patient received as standard therapy treated only~     the tumors that were radiated or ablated. Radiation therapy or ablation plus pembrolizumab~     might lead to a stronger immune response that may control or destroy tumors that did not~     receive radiation therapy or ablation. The purpose of this study is to find out what~     effects, good and/or bad, pembrolizumab has on the patient, and the cancer that did not~     receive radiation therapy or ablation.~   "
47366|NCT02437058|"~     The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency~     departments have not achieved an adequate discriminative ability for decision making.~     Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a~     good predictive ability of the model.2) Create and validate clinical predictive rules of~     mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days~     after ED visit as well as identify predicitive factors of short-term readmission (90~     days)Design: Prospective cohort study. The sociodemographics and clinical variables will be~     collected from emergency medical records to identify predictors. Outcome variables and~     evolution of variables will be collected from hospital medical records / ambulatory during~     admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary~     variables will be identified through logistic regression models using 60% of the final~     sample. The models that best fit will be applied in 40% of the sample to assess the~     predictive validity of this scale.~   "
47367|NCT02437045|"~     Infections of the blood are extremely serious and require intravenous antibiotic treatment.~     When the infection results from antibiotic resistant bacteria, the choice of antibiotic is~     an extremely important decision. Some types of bacteria produce enzymes that may inactivate~     essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level~     production of these enzymes can occur during therapy and lead to clinical failure, even when~     an antibiotic appears effective by laboratory testing. However, this risk of this occurring~     in clinical practice has only been well described in a limited range of antibiotic classes~     in a type of bacteria called Enterobacter. There is currently uncertainty as to whether a~     commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to~     the same risk of resistance developing while on treatment. Infections caused by Enterobacter~     (and other bacteria with similar resistance mechanisms) are often treated with an~     alternative drug called meropenem (a carbapenem antibiotic), which is effective but has an~     extremely broad-spectrum of activity. Excessive use of carbapenems is driving further~     resistance to this antibiotic class - which represent our 'lastline' of antibiotic defence.~     As such, we need studies to help us see whether alternatives to meropenem are an effective~     and safe choice. No study has ever directly tested whether these two antibiotics have the~     same effectiveness for this type of infection. The purpose of this study is to randomly~     assign patients with blood infection caused by Enterobacter or related bacteria to either~     meropenem or piperacillin/tazobactam in order to test whether these antibiotics have similar~     effectiveness.~   "
47368|NCT02437032|"~     A key challenge facing reproductive biologists is the integration of the knowledge about~     oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern~     folliculogenesis, cumulus cell function, and oocyte and embryo development. Although key~     oocyte-secreted factors have been identified, understanding their modes of action is~     complicated by multiple interactions between maternal and oocyte signaling molecules, as~     well as the constantly changing state of physical interactions between the oocyte and its~     companion somatic cells during folliculogenesis. Thus, the investigators study aimed to~     determine if there is any relationship between different gonadotropin preparations and~     oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the~     apoptotic rate in cumulus cells during controlled ovarian stimulation.~   "
47372|NCT02436980|"~     OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early~     period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde~     cholangiopancreatography) METHODS:This randomized and double blind study was performed with~     forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned.~     Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg~     midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients~     who were randomly divided into two premedication groups.~      Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric~     rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was~     considered as cognitive impairment. Recovery period, post-procedure state of cognitive~     function at 60th minute were recorded.~   "
47373|NCT02436967|"~     Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA~     classification (American Heart Association)- comparison between histology and CT. The CT is~     performed with a fast kVp-switching dual energy technique.~      To compare the ability to detect iodine contrast enhancement in the carotid plaque compared~     with 3T MRI with gadolinium.~   "
47374|NCT02436954|"~     While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to~     achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic~     cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade~     (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to~     achieve optimal surgical space condition.~      this difference in the pressure of intra-abdominal CO2 insufflation due to different~     strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in~     patient's respiratory pattern and cerebral oxygenation. Although previous study (studies)~     showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin~     (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic~     cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB~     and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and~     cerebral oxygenation, so far.~      The present study determines and compares the changes CO2 absorption and cerebral~     oxygenation (cerebral perfusion) after applying CO2 insufflation with different~     intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.~   "
47375|NCT02436941|"~     For most cancers, long-term follow-up is the best measure of treatment effectiveness. The~     Department of Radiation Medicine at Loma Linda University Medical Center operates the James~     M. Slater, M.D., Proton Treatment and Research Center, the world's first hospital-based~     proton treatment facility. Patients have been treated at the Center since 1990. Radiation~     treatment has been expanded and refined since the Center's opening, and these changes have~     been based primarily on outcomes seen and evaluated in long-term follow-up.~      The Radiation Medicine Patient Registry (a multi-year database), which began as an~     IRB-approved study in 2003, including detailed follow-up of study data collected from 1990~     and onward, is designed to track all medical information from patients treated with proton~     therapy and/or conventional X-ray therapy at Loma Linda University Medical Center.~     Information gathered from patients treated years or even decades ago helps to determine the~     most effective use of proton and conventional radiation in caring for patients with cancers~     and other diseases.~   "
47376|NCT02436928|"~     This study aims to evaluate the safety and immunogenicity of an inactivated cell culture~     derived H7N9 vaccine in healthy adult subjects.~   "
47377|NCT02436915|"~     The objective of this study is to determine whether augmentation of prefrontal brain~     excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the~     severity of the symptom triad associated with cerebral microvascular disease (CMD); that is,~     slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this~     objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day~     intervention of real versus sham tDCS in 40 subjects.~   "
47378|NCT02436902|"~     Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to~     increase in many countries in coming decades. Though prognosis for patients with HCC is~     generally poor, hepatic resection can be an effective curative treatment, and its~     indications have been expanding in recent years. Resection can be reasonably safe and~     effective even for patients with micro- or macrovascular invasion. However, the recurrence~     rate of HCC is as high as 74% for patients with intermediate and advanced HCC after~     resection. Microvascular invasion is one of the main risk factors which influence risk of~     HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent~     tumor recurrence after resection is so important to improve patient prognosis.~      Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in~     reducing early recurrence rate and mortality for patients with HCC with risk factors of~     recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However,~     the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is~     interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to~     TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and~     microvascular invasion.~   "
47379|NCT02436889|"~     An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard~     anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.~   "
47380|NCT02436876|"~     This study evaluates the safety and clinical benefit of MBN-101 administered~     intraoperatively to infected osteosynthesis sites for patients diagnosed with a fracture~     site infection associated with orthopaedic hardware. Three quarters of the patients will~     receive MBN-101, while the other one quarter will receive placebo.~   "
47381|NCT02436863|"~     The lesion located inside the spinal canal caused big trouble for clinical treatment.~     Traditional laminectomy will destroy the biomechanics and influent the vertebral stability,~     which might cause kyphosis or other deformity. So in some centers, neurosurgeries praised~     laminoplasty to make the intactness of posterior column. They thought the laminoplasty can~     maintain the vertebral stability, and meanwhile the range of motion won't change so much.~     However, some other scholars thought laminoplasty had no helps for stability because of the~     pseudarthrosis. They preferred screw and stick system for internal fixation. And we did meet~     several patients after laminectomy suffered with spinal deformity. So we thought it is~     necessary for investigating the benefit of patients from laminoplasty and internal fixation.~   "
47383|NCT02436837|"~     Background:~      Taking into consideration the ongoing inversion of the population pyramid and the~     limitations and medical conditions, which predispose to episodes of falling among elderly~     people, the implementation of exercises and physical treatments capable of promoting~     postural balance in the group studied is made necessary.~      Objectives:~      Assess the influence of the electronic platform Kinect Sensor® (KS) as a tool in the~     treatment of postural balance in elderly individuals. Method: The study included 10 elderly~     (60 to 70 years old) and 10 young (20 to 30 years old) individuals. Treatment protocol~     composed of five weeks with sessions performed twice a week with application of KS. Initial~     and final evaluation included static and dynamic balance instruments: Berg Balance scale and~     Timed up and Go and Romberg Tandem tests.~   "
47384|NCT02436824|"~     The objectives of this study are to examine the safety, tolerability, and efficacy of~     repeated topical administration of AB001 topical patches for the treatment of chronic low~     back pain.~   "
47385|NCT02436811|"~     This is study aims to evaluate the retention of information on oral health and eating habits~     in children under two years of age. A total of 180 pregnant women aged between twelve and~     fifty years of age will be selected for this study. Before the randomization process, the~     literacy in oral health score will be assessed through previously validated instrument~     BREALD- 30. Participants will be randomly selected according to the value of BREALD-30,~     categorized as adequate (≥18) and low (<18) in a specific intervention. Interventions occur~     in written form through an educational brochure or standardized oral, both with information~     about the feeding practices and oral health in children under two years. The control group~     will be the implementation of an educational booklet on oral cancer. To evaluate the~     association between variables pregnant women will respond to a semi-structured form with~     questions regarding oral health and nutrition, in three different times: before the~     intervention, 15 minutes after the intervention and 4 weeks after the intervention. Social~     and economic and demographic data will be evaluated at baseline. The data will be~     statistically analyzed by Student's t-tests and ANOVA paired, adopting a 5% significance~     level. In the event of non-normality of the data, the corresponding non-parametric~     statistical tests will be applied. This study has the hypothesis that the written~     intervention presents best results in participants with high literacy and the standardized~     oral with those with low literacy.~   "
47386|NCT02436798|"~     5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea~     and vomiting. However, these medications also associated with potentially severe and~     life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data~     regarding the cardiac safety and inter-individual variability in cardiac effects of~     ondansetron when used in vulnerable populations such as children and pregnant women are very~     limited. The results of this study will enable better-informed therapeutic decision-making~     regarding the use of ondansetron in children and pregnant women, with the overall goal to~     improve the safety of these commonly used antiemetic medications. Furthermore, predictive~     pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify~     patients at risk of cardiac toxicity before the drug is administered.~   "
47387|NCT02436785|"~     Pain management is rated by patients with inflammatory arthritis as the highest priority in~     their disease treatment. Past research showed that music therapy is associated with reduced~     pain and depression. The purpose of this study is to better understand the effectiveness of~     music therapy for people with inflammatory arthritis. Participants will be randomly assigned~     to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group~     that listens to a relaxation CD (compact disc). Standardized tests will determine if~     participating in music therapy group helps reduce pain and depression, improve physical~     function and confidence levels in applying self-management strategies.~   "
47388|NCT02436772|"~     This study evaluates the performance of a blood test for detecting biomarkers in metastatic~     breast cancer patients at one clinic against standard testing.~   "
47389|NCT02436759|"~     This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic~     Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and~     comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.~   "
47390|NCT02436746|"~     Both Neurofibromatosis type 1 (NF1) and Tuberous Sclerosis Complex (TSC) are highly~     heterogeneous diseases. Cognitive features seem to vary widely even between family members~     carrying the same mutation. This phenotypic variability is not well understood, but is~     generally assumed to be caused by modifier genes which regulate the affected pathways.~     However, recent studies brought forward an alternative explanation for the phenotypic~     variability. Post-mortem studies showed that second hit mutations causing loss of the second~     ('healthy') allele are more widespread than previously believed. These loss of~     heterozygosity (LOH) mutations cause bi-allelic loss of the disease-linked gene and are~     known to cause the gross of somatic features in both diseases (like neurofibromas and~     hamartomas). Hence, it could be the stochastic occurrence of second-hit mutations in the~     brain are the cause of the variable cognitive phenotypes.~      To investigate to what extent these LOH mutations in the brain contribute to the phenotype~     and to what extent this variation is due to genetic modifiers factors is unknown. The~     investigators therefore propose to elucidate this variability by comparing the correlation~     of cognitive features of monozygotic twins with NF1 or TSC to healthy twins in the~     population. If modifier genes are the cause of the variability of cognitive features in NF1~     and TSC the investigators expect that the variability in cognitive tests in monozygotic~     twins is the same as monozygotic twins in the healthy population. However, if the~     variability is caused by the occurrence of LOH mutations, the investigators expect to have a~     lower correlation in our monozygotic patients compared to the healthy twins.~   "
47391|NCT02436733|"~     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early~     stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of~     chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every~     three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for~     non-progressing patients~   "
47406|NCT02436538|"~     Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric~     glycoprotein that belongs to the transforming growth factor-beta family. It is involved in~     the regression of the Müllerian ducts during male fetal development. In the female, AMH is~     solely produced by the granulosa cells of preantral and small antral follicles, and~     regulates ovarian activity and follicular steroidogenesis~   "
47392|NCT02436720|"~     The literature on outcome measures assessing upper limbs in Duchenne muscular dystrophy~     (DMD) is quite scanty. While there have been considerable advances for ambulant DMD boys, no~     prospective study has so far been devoted to outcome measures in non ambulant patients, with~     increasing complaints from families and patients. This information appears to be highly~     important not only for a better understanding of the progression of the disease but also for~     possible enrollment of patients in future trials.~      The aim of this project is to identify outcome measures for non ambulant patients in an~     Italian population of DMD patients. At least 200 non ambulant DMD boys and adults will be~     included in the study. All patients will be assessed using the newly developed Performance~     of Upper limb (PUL) test. This measure will be used at baseline and 6 and 12 months after~     baseline. This will allow to monitor possible changes over time and the rate of changes in~     patients with different level of ability and age. As part of this study the investigators~     will also correlate possible changes in upper limb function with other measures of care and~     function such as the EK scale.~      The investigators aim to assess the suitability of the individual measures in a large number~     of patients, trying to establish whether whole scales or individual items appear to be~     relevant across ages and level of abilities. The investigators also aim to assess the~     suitability of the selected measures in a multicentric setting and the quantity of training~     required The data collected will also be analysed using Rasch analysis in order to improve~     the statistical properties of the measures used.~   "
47393|NCT02436707|"~     The purpose of this study is to find out what effects new combinations of treatment will~     have this disease. In this clinical trial, the study treatment options currently are~     ibrutinib plus R-GDP, or R-GDP alone.~   "
47394|NCT02436694|"~     Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and~     sciatic nerve block improve analgesia postoperatively in patients submitted to total knee~     arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the~     local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.~      Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid~     consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side~     effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and~     falls).~   "
47395|NCT02436681|"~     Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived~     from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an~     indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will~     serve to provide clinicians with high-quality clinical data in order to provide them with a~     higher degree of confidence when selecting MIROMESH for hiatal hernia repair.~   "
47396|NCT02436668|"~     This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel~     and gemcitabine for the first line treatment of patients with metastatic pancreatic~     adenocarcinoma.~   "
47397|NCT02436655|"~     Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left~     ventricular ejection fraction remains controversial. The investigators therefore try to~     compare clinical outcomes of elective aortic valve replacement to conventional treatment and~     watchful waiting strategy in a prospective randomized trial.~   "
47398|NCT02436642|"~     The devices used in this observational registry are the Osprey Medical Contrast Monitoring~     System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE~     Mark designations. The purpose of this registry is to evaluate the usability characteristics~     of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal~     clinical use.~   "
47399|NCT02436629|"~     The objective of the current study is to assess the effect of 6-day dietary nitrate~     ingestion on high intensity intermittent sports performance in recreational soccer players.~   "
47400|NCT02436616|"~     The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively~     investigate the cerebral electrical activity of infants with Apnea, Bradycardia and~     Desaturation events. This project will also assess the feasibility of using the microEEG~     device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote~     centralized interpretation in this setting.~   "
47401|NCT02436603|"~     The purpose of this project is to examine whether a low cost, group-oriented integrative~     medicine approach to irritable bowel syndrome improves participant outcomes. The~     intervention will combine nutrition counseling on the low FODMAP diet (decreased grains and~     other disaccharides) and mind-body training with follow-up health coaching.~      These participants will be randomized to either a 4-week group-oriented treatment~     intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides,~     monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health~     coaching follow-up period or a waitlist control group. At the end of the 12-week study~     period, waitlist subjects will be offered the four-week nutrition and mind-body~     intervention. Over the 12-week study period, we will examine and report on the impact of~     this treatment intervention on IBS symptoms and quality of life in this population. The~     investigators will collect data on IBS outcomes as well as on depression and stress.~   "
47402|NCT02436590|"~     The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA~     joints associated with a reduction of inflammation and improved homeostasis of the~     extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain,~     reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint~     structure.~   "
47403|NCT02436577|"~     This study will be an open-label, randomised, three-period, three-treatment, crossover study~     in healthy Japanese male and female of non-childbearing potential subjects, performed at a~     single study centre.~      The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD)~     tablets when administered with water and without water and ticagrelor immediate-release (IR)~     tablets.~   "
47404|NCT02436564|"~     The primary objective is to develop an in vitro model of cancer for laboratory study using~     liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic~     and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the~     investigators hope to compare molecular and cellular biology of cancer cells with normal~     cells as well as potentially test the efficacy of current and future anti-cancer therapies.~      Samples will be collected from tissue that has been resected as part of the treatment for a~     patient diagnosed with liver, bile duct or pancreas cancer.~   "
47408|NCT02436512|"~     The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of~     GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation~     predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health~     Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically~     necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo~     an attempt to wean from parenteral PGI per standard of care.~   "
47409|NCT02436499|"~     Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from~     chronic migraine on function MRI imaging, before and after treatment.~   "
47410|NCT02436486|"~     To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy~     men.~   "
47411|NCT02436473|"~     The purpose of this study is to evaluate the effect of the test toothpaste containing 1150~     parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel~     specimens, in an in situ caries model system, by comparing the differences in net~     remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0~     ppm F) reference control toothpaste.~   "
47412|NCT02436460|"~     This phase Ib trial studies the side effects and best dose of neihulizumab in treating~     patients with acute graft-versus-host disease (aGVHD) that does not respond to steroid~     treatment undergoing stem cell transplant. Sometimes after a stem cell transplant, the~     transplanted cells from a donor can make an immune response against the body's normal cells~     (called GVHD). Monoclonal antibodies, such as neihulizumab, may be an effective treatment~     for GVHD by binding to a protein found on the surface of immune cells (T cells).~   "
47413|NCT02436447|"~     This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over~     18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous~     infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to~     be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6~     subjects.~   "
47414|NCT02436434|"~     Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field~     and heat bursts at a temperature less than 42°C to neural tissue. In contrast with~     conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many~     studies have shown its benefits in pain relief for certain kinds of chronic pain conditions.~     For lessening pain of certain joint arthropathy, the direct nerve block by application of~     PRF is difficult and complicated because the supplying nerve of joint is complex or small.~     Hence, some authors perform intra-articular PRF on the chronic painful joint for example,~     knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate~     and shoulder joint and the excellent long-term effects are reported.~      The purpose of this study is to investigate the effect of intra-articular PRF in~     osteoarthritis.~   "
47415|NCT02436421|"~     This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for~     use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for~     patients with uncontrolled blood pressure and one for patients with atrial fibrillation not~     on anticoagulation.~   "
47416|NCT02436408|"~     Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial~     structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.~      Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in~     which the Hh signaling pathway appears to contribute to the development and maintenance of~     tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA)~     for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that~     vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is~     eventually required~      In order to assess the potential of vismodegib to improve the ophthalmic outcomes following~     treatment for orbital and/or periocular BCCA, this study will follow patients with~     globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated~     with vismodegib as standard of care.~   "
47417|NCT02436395|"~     Surgical site infections (SSIs) is one of the most common complications of upper abdominal~     surgery. Previous studies found that type of surgical incision, emergency operation or not,~     surgical duration, age of patient, body mass index, malignance duration, malnutrition,~     complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids)~     are closely associated with the incidence of SSIs. The general incidence rate of SSIs was~     about 5% to 40%, although using the preoperative skin disinfectant and other methods to~     prevent and reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk~     of infection, SSIs is an important problem which cannot be ignored. On the other hand,~     gastric cancer is one of the most common digestive system tumors, and gastrectomy is the~     primary therapeutic options. Therefore, it is important to compare the whether the different~     liquid (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can~     influent the incidence of the SSIs.~   "
47418|NCT02436382|"~     Neonatal hypothermia is associated with increased risk of mortality as well as multiple~     morbidities. The investigators objective is to determine if an increase in ambient operative~     room temperature decreases the rate of hypothermia. Operating room temperature will be~     randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly~     basis for a period of six months.~   "
47419|NCT02436369|"~     The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids~     to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel~     randomized controlled trial the investigators recruited 70 diabetic patients and randomly~     allocated to control and treatment groups. Participants in treatment group consumed 30 gr~     flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily.~     Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood~     pressure, weight, waist circumference and body mass index were measured at the first and end~     of the trial.~   "
47491|NCT02435420|"~     This is a retro-prospective, single arm, sequential enrolment study to collect relevant~     clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who~     have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to~     assess its safety and efficacy over 5 years post-surgery.~   "
47420|NCT02436356|"~     The goal of this study is to determine whether two new, non-X-ray techniques can~     discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures~     (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk~     areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not~     particularly effective at identifying individuals who are at risk of suffering a fracture.~     Yet, there is a growing population of diabetics and elderly individuals prone to fractures.~     In effect, the age-related and diabetes-related increase in fracture risk is independent of~     a person's aBMD. These findings stress the urgency in developing diagnostic tools that can~     improve fracture risk prediction so that patients can be treated with the appropriate~     anti-fracture therapies.~   "
47421|NCT02436343|"~     The aim of this work is to Assess serial changes in cardiovascular function in morbidly~     obese pregnant females (BMI equal or higher than 30 kg/m2) as compared to normal lean~     pregnant female controls.~   "
47422|NCT02436330|"~     Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted~     weight management program in a randomized controlled trial (RCT). Primary objective: to~     assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on~     cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming~     component on attendance and participation.~   "
47423|NCT02436317|"~     This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is~     to evaluate the benefit of adding POC US to the management of inpatients admitted to the~     internal ward with respiratory, cardiovascular or hemodynamic abnormalities.~   "
47424|NCT02436304|"~     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to~     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).~   "
47425|NCT02436291|"~     Open label study to evaluate the efficacy of CURE-EX device in the treatment of~     onychomycosis.~   "
47426|NCT02436278|"~     This study investigates whether usual walking speed, measured by the 4 metre gait speed test~     (4MGS), and change in usual walking speed over 6 months predicts death and hospital~     admissions in patients with Idiopathic Pulmonary Fibrosis.~   "
47427|NCT02436265|"~     Caudal injection of local anesthetic is a neuraxial technique routinely performed on young~     children for postoperative analgesia after lower abdominal and lower extremity surgical~     procedures. One of the major limitations of the use of single shot neuraxial injections for~     this purpose is the limited duration of action of the injected local anesthetic. Adjuvant~     medications, such as clonidine and epinephrine, have been added to the local anesthetic to~     prolong the duration of the neuraxial block, with varying results. Dexamethasone is a~     synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude~     of indications, including the prolongation of local anesthetic based analgesia. It has been~     shown that the administration of dexamethasone either intravenously or via perineural~     injection can significantly increase the duration of analgesia derived from a local~     anesthesia based peripheral nerve block. Literature also suggests that the effect of~     dexamethasone is equivalent whether given intravenously or perineurally. Interest in~     dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal~     anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using~     a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric~     population outside of airway procedures, which may expose patients to dose related side~     effects of dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective~     for analgesic prolongation, but no direct study of low dose intravenous dexamethasone in~     combination with caudal anesthesia has been performed.~   "
47428|NCT02436252|"~     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for~     whom no effective therapies currently exist.~   "
47429|NCT02436239|"~     The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone~     for the treatment of MDD in pediatric outpatients (7-17 years).~   "
47430|NCT02436226|"~     The purpose of this study is to evaluate the effect of administration of low dose of human~     chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation~     in infertile women having CC resistant polycystic ovarian syndrome (PCOS).~   "
47431|NCT02436213|"~     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the~     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This~     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary~     exercise tests performed on a stationary bicycle.~   "
47432|NCT02436200|"~     This study will assess the benefit of a neuromuscular electrical stimulation device in~     patients suffering from symptoms and effects of lower limb intermittent claudication.~   "
47433|NCT02436187|"~     The aim of the study is to quantify the excess mortality associated with non-adherence to~     care for non ST-elevation myocardial infarction in England and Wales over the last decade.~   "
47434|NCT02436174|"~     Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment~     of shivering has been based on a simple scale using descriptive words rather than actual~     measurements. We believe that we can assess shivering more scientifically by using a novel~     method to quantify arm movements during shivering.~   "
47451|NCT02435940|"~     My Retina Tracker® is a registry for people affected by an inherited retinal degenerative~     disease. It is a patient-initiated registry accessible via a secure on-line portal at~     www.MyRetinaTracker.org. Affected individuals and genetically related, unaffected, family~     members who create entries are guided to create a profile that captures the participants'~     perspective on their disease and its progress; family history; genetic testing results;~     preventive measures; and interest in participation in research studies. The participants may~     also choose to ask their clinician to add clinical measurements and results at each clinical~     visit. Participants are urged to update the information regularly to create longitudinal~     records of their disease, from their own perspective, and their clinical progress. The~     overall goals are: to better understand the heterogeneity of the inherited retinal~     degenerative diseases; to understand the prevalence of the different diseases and gene~     mutations; to assist in the establishment of genotype-phenotype relationships; to help~     understand the natural history of the diseases; to help accelerate research and development~     of clinical trials for treatments; and to provide a mechanism that facilitates more rapid~     recruitment for research studies and clinical trials.~   "
47435|NCT02436161|"~     OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management~     collaborative program for high-risk patients with heart failure (HF) who are admitted at~     hospital, based on the 6 components of the Chronic Care Model PROMIC, in terms of~     reduction of a Combined event rate (readmissions / cardiac events / death / emergency~     department visits) and other variables, the feasibility of the program, the improvement on~     quality of life related to health and functional capacity of the PROMIC patients compared~     with control patients in usual care.~      DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS:~     Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba,~     Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque~     Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in~     New York Heart Association (NYHA) functional status II-III-IV from previous mentioned~     hospitals. Another 125 patients from different primary health care centers, will be the~     control group.~      INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive~     usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the~     time of inclusion to the first event (readmission / cardiac events / death / emergency~     visits). Secondary endpoints will be the quality of life related to health (MLFHQ and~     SF-12), functional capacity (6-Minute Walk Test), structural changes in cardiac structure~     (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the~     program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor~     variables also will be collected such as sex, age, education level, co-morbidity, social~     risk level, dependency etc.~      STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will~     done. A model of Cox proportional hazards will be built.~   "
47436|NCT02436148|"~     The present study assesses the reliability and validity of the Finnish version of Prothesis~     Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for~     the present study from the Helsinki and Uusimaa Hospital District and the Central Finland~     Health Care District.~   "
47437|NCT02436135|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of~     idelalisib in adults receiving ruxolitinib as therapy for intermediate to high risk primary~     myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis~     (post-PV MF or post-ET MF) with progressive or relapsed disease.~   "
47438|NCT02436122|"~     The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa)~     outcome remains controversial. Thus, the investigators aim to examine the association of~     preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).~      The investigators will prospectively collect the relevant data including preoperative HbA1c~     in 264 patients of PCa patients undergoing RP. The associations between clinical variables~     and risk of adverse pathological features and disease recurrence will be tested using a~     multivariate logistic regression and multiple Cox-proportional hazards model, respectively.~   "
47439|NCT02436109|"~     Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes~     spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle~     is placed in the lower back and local anesthetic is injected to freeze the body. Normally,~     before the needle is placed in a patients' back, the anesthesiologist will feel between~     their back bones with his/her fingers to find the right spot for the needle. This study will~     be evaluating if the distance from the skin to the appropriate spinal space measured with a~     novel 3D Ultrasound will equal the actual depth of the needle insertion.~   "
47440|NCT02436096|"~     The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of~     Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202~     study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial~     effects upon pain, sleep and other FM symptomatology.~      The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg~     tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.~   "
47441|NCT02436083|"~     The purpose of this study is to monitor and compare peri-operative problems and outcomes of~     reconstructive surgery with microvascular free flaps in the head and neck region between~     groups of patients treated with perioperative antibiotics and a group of patients without~     antibiotics.~   "
47442|NCT02436070|"~     BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency~     Department (ED) providers treated over 3,500 cases of asthma-related complaints at~     Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds~     billions of dollars annually when including direct cost and lost productivity. Many of these~     visits and resultant costs are avoidable. Patients with well-controlled asthma do not~     typically exhibit these patterns, while patients with poorly controlled asthma show patterns~     of increased utilization of healthcare resources and lower quality of life. Evidence~     suggests that a text message reminder and educational program might positively influence~     pediatric asthma care practices.~      RESEARCH QUESTION Does a targeted ED based text message intervention program improve~     outpatient follow-up and routine preventive care in pediatric asthma patients?~      METHODS Study subjects will be block randomized based on age and insurance group. The~     experimental group will receive text messages with guidance towards follow-up care with~     their PCP and the importance of the flu vaccine for children with asthma. The control group~     will receive a series of educational self-care and health based text messages unrelated to~     asthma or the flu vaccine. Some self-report of behaviors will be captured via text message~     response.~      ANALYSIS Primary outcomes for the educational versus targeted text message groups will be~     compared use Chi-square tests. Additional adjustments may be applied for missing data or if,~     despite randomization, there is substantial imbalance between group in key covariates (eg~     race/ethnicity, insurance type or asthma severity.)~   "
47452|NCT02435927|"~     This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with~     CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive~     CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.~   "
47453|NCT02435914|"~     This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics~     of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575~     vehicle in patients with dry eye disease.~   "
47454|NCT02435901|"~     This study will evaluate the use of reduced intensity conditioning regimen in patients with~     high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard~     immunosuppressive medications, followed by a routine stem cell transplant in order to assess~     whether or not it is as effective as myeloablative high dose chemotherapy and transplant.~   "
47504|NCT02435251|"~     The purpose of this research is to study changes in weight, body mass index, and percentage~     of fat following orthopaedic knee or shoulder surgery.~   "
47443|NCT02436057|"~     Through a four-year grant awarded to the University of California at Los Angeles in 2009,~     Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and~     initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National~     Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System~     (PROMIS). By the end of the grant period in July 2013, the project team had successfully~     developed and initially validated eight scales measuring the most common GI symptoms.~      Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology~     Research Laboratory (CTRL) and the University of Michigan Center for Healthcare~     Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms~     (AEGIS) algorithm which is delivered via My GI Health, an open-‐source Internet based~     patient-provider portal (P3) designed to enhance the delivery of GI health care~     (www.MyGIHealth.org). Through My GI Health and AEGIS, patients are able to complete PROMIS~     GI symptom measures and provide additional information about their GI symptoms and histories~     from computers, tablets or smart phones without the constraints of physical locale. This~     information is condensed into a GI PROMIS scores report and initial GI history that~     patients' providers can review prior to or concurrent with seeing the patient. The report,~     which can be incorporated into the electronic health record (EHR), helps busy clinicians to~     quickly understand the patient's complaints, document their symptoms and GI history, and~     leaves more time for conversation with the patient.~      Beyond focusing their interaction, My GI Health also supports both the clinician and patient~     with an individualized educational prescription which guides the patient through a library~     of multi‐media educational materials on GI symptoms, conditions, and treatments also~     contained within the website. The prescription is initially created by the website based on~     each patient's unique GI PROMIS fingerprint, and can be modified by the provider based on~     their interaction with the patient. The clinician and patient can also access the~     PROMIS-tailored education in the exam room to jointly review pertinent materials, including~     animations of normal and abnormal GI functions, further reinforcing the patients'~     educational experiences around the PROMIS symptoms.~      The aim of this current study is to validate the use of GI PROMIS in clinical practice by~     conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel~     e--platform vs. usual care.~   "
47444|NCT02436044|"~     A large proportion of Asian patients with HCC present with locally advanced or metastatic~     disease,at which point they are ineligible for curative treatments.Oxaliplatin plus~     fluorouracil/leucovorin intravenous infusion was proved effective in prolonging~     progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with~     advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely~     used method for primary or metastasis liver tumor with high local tumor response. To our~     knowledge, there have not been any prospective studies to assess the safety and effecacy of~     HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced~     HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC~     using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.~   "
47445|NCT02436031|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator~     muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA~     compared to normal subjects. Until recently, the search for medicines to activate pharyngeal~     muscles in sleeping humans has been discouraging. However, exciting new animal research has~     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic~     effects) on upper airway collapsibility and genioglossus muscle activity (EMG GG) during~     sleep in OSA patients.~   "
47446|NCT02436018|"~     Low pulse oximetry is the most common adverse events during sedation for upper~     gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present~     study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL~     JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be~     evaluated.~   "
47447|NCT02435992|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     Ulcerative Colitis (UC).~   "
47448|NCT02435979|"~     This study will be a randomized controlled trial comparing proximal strengthening vs.~     traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy~     sessions per week for 4 weeks. Change in patient function and pain as measured by the~     patient rated wrist evaluation will be the primary outcome of interest~   "
47449|NCT02435966|"~     The investigators study the efficacy of a combination of dry needling plus manual therapy~     against sham dry needling plus manual therapy in the treatment of chronic neck pain. The~     investigators identify the most active trigger point in the upper trapezius and levator~     scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days~     after the first intervention. The primary outcome is the Visual Analogue Scale of Pain.~     Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and~     range of motion.~   "
47450|NCT02435953|"~     The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter~     arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported~     to be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA~     to have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm).~     However, to the investigators' knowledge, there have not been any prospective studies to~     assess whether TACE combined sequentially with RFA is more effective than TACE alone for the~     treatment of intermediate-stage HCC. The investigators hypothesized that the combination of~     TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of~     this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone~     for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was~     defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic~     lessions, largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or~     extrahepatic metastases.~   "
47455|NCT02435888|"~     Predictive equations are the main clinical tool for determining resting energy expenditure~     (REE). Thus, it is important to investigate the accuracy and agreement of these equations in~     different populations and context of diseases. The purpose of this study is to investigate~     the accuracy and agreement of predictive equations of REE in overweight women with~     polycystic ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means~     of indirect calorimetry and predicted (pREE) through ten equations basing on the~     anthropometric parameters (Harris & Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU~     including weight and height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones,~     Müeller, De Luis and Lazzer).~   "
47456|NCT02435875|"~     Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play~     an important role in the long-term development of hypertension. Perioperative patients with~     hypertension is rapidly growing in all populations worldwide. However, no study has reported~     the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for~     hypertension in a surgery cohort.~   "
47461|NCT02435810|"~     Background:~      - Inflammation is how the body reacts to infection or injury. . Infections or inflammation~     in the brain and nerves can be serious. There aren t always good tests to detect this.~     Researchers want to learn more about how diseases affect the brain and nerves to develop~     better tests and treatments.~      Objective:~      - To learn more about how inflammation and infections hurt the brain and nervous system.~      Eligibility:~      - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system~     infection or inflammation.~      Design:~        -  For some participants, a clinician outside of NIH will collect blood, tissue, and other~          samples. These will be sent to NIH and analyzed.~        -  Other participants will have several visits to NIH. Children may not have all these~          tests.~        -  Participants will have:~        -  Medical history.~        -  Physical and neurological exam.~        -  Blood and urine samples collected.~        -  Saliva collected. They will chew on a piece of sterile cotton for one minute.~        -  Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong~          magnetic field. Participants will lie on a table that slides in and out of the~          cylinder. Participants will get a contrast agent through an intravenous (IV) catheter~          during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an~          arm vein.~        -  Lumbar puncture. Skin will be numbed and a needle will be inserted into the space~          between the bones in the back. Fluid will be removed.~        -  Some participants may have optional study procedures. These may include eye tests,~          memory and thinking testing, tests with electrodes on the head, or skin biopsy.~   "
47462|NCT02435797|"~     To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction~     (AMI) reduces reperfusion injury.~   "
47463|NCT02435784|"~     The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et~     al. (2002). It aims to provide an opportunity for patients to voice their needs and problem~     to minimize the discrepancy and miscommunication between patient and professional carer. In~     this randomized controlled trial, the investigators aim to examine whether using 2-COM~     checklist would lead to improvement in first episode psychosis patient's overall~     satisfaction, change in treatment option in clinicians and consultation time.~   "
47464|NCT02435771|"~     Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES~     data collection there was a near doubling of patients with vitamin D deficiency in 10 years.~     Vitamin D deficiency is associated with several adverse outcomes such as increased~     fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction.~     The increasing prevalence of vitamin D deficiency has been attributed to the increasing~     prevalence of obesity. Several studies have shown that obese patients have lower 25-OH~     vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more~     vitamin D compared to nonobese patients. The most commonly prescribed medication to replete~     vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been~     published to evaluate a standard protocol in the treatment of vitamin D insufficiency in~     adults.~   "
47465|NCT02435758|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic~     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual~     function disorder. However, 32%-44% patients still suffered from urinary and sexual function~     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).~      In the early stage of work, the investigators performed preservation of Denovilliers' fascia~     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low~     rectal cancer patients. The results showed that preservation of Denovilliers' fascia in~     L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In~     order to further confirm the early work, the investigators design a multicenter randomized~     controlled clinical trial to compare differences in urinary and sexual function protection~     and long-term outcomes between preservation and excision of Denovilliers' fascia in~     L-PANP-TME.~   "
47466|NCT02435745|"~     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of~     inherited connective tissue disorders characterized by joint hypermobility, skin~     hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage~     defects, craniofacial abnormalities and increased pharyngeal collapsibility have been~     proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on~     questionnaires that EDS patients might be more frequently affected by OSA and sleep~     disturbances than the general population. However, the actual prevalence of OSA in patients~     with EDS is unknown.~      Aortic root dilation and dissection are common complications of EDS and little is known~     about the underlying risk factors. Preliminary evidence suggests a link with OSA but this~     has not yet been investigated.~      The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100)~     compared to a matched control group (100). The secondary objective of this pioneer study is~     to assess whether there is a relationship between OSA severity and aortic~     diame-ter/craniofacial abnormalities in EDS patients.~   "
47467|NCT02435732|"~     Limiting brain death-induced organ injury through a systemic anti- inflammatory medical~     management should allow for improvement in the quality of transplanted organs, and as a~     result, clinical improvement in post-transplant outcomes represented by a decrease in the~     incidence of delayed graft function (DGF) after transplantation.~      The specifc aim is to evaluate the effect of C1INH (CINRYZE) as a donor pre-treatment~     strategy to decrease systemic inflammation and decrease the incidence of DGF in Expanded~     Criteria Donors (ECD), currently identified as donors with Kidney Donor Profile Index (KDPI)~     over 85%.~   "
47479|NCT02435576|"~     The primary and general objective of the clinical introduction of the SFP as the current~     standard of care is to improve the quality of radiotherapy for head and neck cancer patients~     by reducing radiation-induced side effects without hampering treatment efficacy in terms of~     locoregional tumour control and overall survival and to systematically evaluate the~     beneficial effect of newly introduced radiation technology for this particular group of~     patients. The clinical introduction of the SFP will allow for a systematic and broad scale~     quality improvement cycle for head and neck cancer patients treated with radiotherapy. In~     fact, this methodology can be considered a kind of quality circle for the clinical~     introduction of new radiation techniques, aiming at continuous efforts for further~     improvement.~   "
47468|NCT02435719|"~     Ministry of Health through the National Medical Stores has supplied alcohol-based handgels~     to the different health facilities in Uganda for the health care providers to use during~     clinical care. However, constant stock-outs and or limited supplies remains the main~     constraint faced by the hospitals. Thus the handgels are generally used by a few of the~     senior health care providers.~      The promotion of bedside, antiseptic handrubs largely contributes to the increase in~     compliance and sustained improvement of hand hygiene compliance reduces Health care acquired~     infections (HCAIs), but it is not yet established how cost- effective the intervention is in~     a a rural Ugandan hospital where funds are severely rationed and, which serves over 4~     million people in over 15 districts in Uganda. An evaluation of an intervention's~     cost-effectiveness is a crucial factor in whether the government will be prepared to fund~     the intervention and sustain it.~      This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health~     care workers in Mbale Regional Referral Hospital.~   "
47469|NCT02435706|"~     A randomized controlled trial of 12-month duration to compare gingival margin location,~     buccal horizontal ridge dimensions, and interproximal crestal bone levels following two~     surgical approaches for immediate placement of implants in the esthetic zone: one involving~     flap elevation and another using a flapless protocol.~   "
47470|NCT02435693|"~     Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule~      Objectives:-~        1. To evaluate Pharmaceutical care program in Type2 diabetics.~        2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with~          Type-2 Diabetes Mellitus.~        3. To study the prevalence of Type2 diabetics cases in Dhule.~        4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2~          diabetics.~        5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.~        6. To study the impacts of Pharmaceutical care program on glycemic control in patients~          with Type-2 Diabetes Mellitus.~        7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital~          Dhule.~        8. To compare the efficiency of Pharmaceutical care program and drug in patients with~          Type-2 Diabetes Mellitus.~        9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.~       10. To increase the patient compliance and positive attitude of patients towards the~          diabetes disease by counseling.~   "
47471|NCT02435680|"~     To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and~     gemcitabine (carbo/gem) in advanced TNBC patients~   "
47472|NCT02435667|"~     The objective of this proposal is to determine the effect of resistance exercise training on~     locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF~     patients with preserved ejection fraction (HFpEF).~   "
47473|NCT02435654|"~     In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7~     years old and onset of illness before 17 years old, and all EOS patients will receive a~     8-week systematic olanzepine titration treatment and a battery of assessments of treatment~     effect and safety. Blood olanzepine plasma concentration will be tested regularly and~     genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by~     Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan~     probes genotyping technology. The aim of the study is to explore the predictive factors on~     olanzepine treatment response in EOS, which can guide the individualized treatment and~     improve the cure rate of EOS in clinical setting.~   "
47474|NCT02435641|"~     The current study has the following objectives:~        1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression,~          PTSD, satisfaction with life and quality of life in both patients and caregivers, after~          controlling for injury severity and impairment.~        2. To determine factors associated with patient and caregiver satisfaction with medical~          care at time 2 and time 3.~      The investigators would thus be able to identify the best time point for intervention~     delivery, intervention targets, and risk factors for chronic psychological distress.~   "
47475|NCT02435628|"~     This is a prospective study through the NF clinic at Massachusetts General Hospital that~     will examine the relationship between psychosocial factors, health literacy, and~     satisfaction with the medical visit in adults with NF1, NF2, and Schwannomatosis. A total of~     89 participants will be enrolled in the study.~   "
47476|NCT02435615|"~     Dengue is the most common viral illness spread by mosquitos. It is important to diagnose~     dengue to prompt adequate therapy and initiate local mosquito control. Easy to use point of~     care tests are needed to improve dengue diagnosis. Oral fluid collection may be a simple,~     non-invasive way to diagnose dengue in the community. However, it is currently unknown if~     oral fluid is an accurate way to diagnose dengue and if the use of a specialized oral fluid~     collector could help to improve dengue diagnosis. In this study, the investigators will~     analyze the oral fluid of suspected dengue patients compared to serum samples for dengue~     diagnosis. From this information the investigators will be able to determine if oral fluid~     is a convenient way to diagnose dengue and if the oral fluid collector aids in improving~     diagnosis.~   "
47477|NCT02435602|"~     This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol~     chromoendoscopy in the early detection of esophageal cancer in patients with prior head and~     neck cancers.~   "
47478|NCT02435589|"~     The purpose of this study is to investigate the effectiveness of a systematic approach to~     pain assessment in the critically ill patients' outcome The investigators hypothesize that,~     patients who will undergo systematic pain assessment and they will have their results~     notified to physicians and nurses, will demonstrate favorable effects on pain intensity,~     more efficient use of sedatives and analgesics, duration of mechanical ventilation, length~     of ICU stay, mortality, adverse events and complications, in relation to patients who will~     receive standard care alone. Moreover it is expected that they will demonstrate altered~     levels of plasma neuropeptides and biochemical markers in peripheral blood.~   "
47489|NCT02435446|"~     Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative~     assessment of otosclerosis.~      The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating~     and, therefore, could replace the CT.~      In this study, a CBCT will be proposed to all patients undergoing a CT exam for the~     diagnosis and/or the pre-operative assessment of an otosclerosis.~      The results of the CBCT will be compared to those of the CT scan.~   "
47480|NCT02435563|"~     Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to~     clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks.~     Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active~     metabolite. Because of the remarkable progress in HIV therapies the number of older age~     patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV~     therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is~     contraindicated in these patients because of the expected interaction and bleeding risk. A~     lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of~     ritonavir has been already demonstrated. Therefore, administration of a lower dose of~     ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this~     pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in~     case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as~     administered alone using a physiologically-based pharmacokinetic (PBPK) model.~      As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite~     will be created based on available in vitro and in vivo parameters in healthy volunteers.~      An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers~     at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first~     session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the~     volunteers and obtained pharmacokinetic data will be fitted into the model for optimization.~     Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg~     ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time~     profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to~     minimize the magnitude of this interaction will be calculated. This new dose will be~     co-administered with ritonavir in the same volunteers during the second session of the~     clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg~     ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a~     single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be~     measured in both sessions of the clinical trial using two specific platelet function tests:~     the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same~     PK profile, the same pharmacodynamic activity is expected. The modulation of activity of~     CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and~     fexofenadine as probe substrates.~      The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to~     broaden the application field of ticagrelor, especially in HIV patients. Since PK models are~     often created after clinical observations, the prospective aspect of this study is of~     particular value as the model will be first created and then applied to an unknown clinical~     scenario.~   "
47481|NCT02435550|"~     The purpose of this study is to use genomic information from individual patients to create~     simulation avatars that will be used to predict novel drug combinations with therapeutic~     potential.~   "
47482|NCT02435537|"~     The current study investigated the effect of adding dexmedetomidine to intrathecal morphine~     for postoperative analgesia in cancer patients undergoing major abdominal surgery.~   "
47483|NCT02435524|"~     The time between birth and age 24 months provides a unique opportunity to impact the~     long-term health and development of children through improved infant and young child feeding~     practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around~     25% in infants younger than six months.~      The purpose of this study is to evaluate whether the Alive & Thrive intervention package,~     consisting of interpersonal counselling and community mobilisation activities, can increase~     the exclusive breastfeeding rate among infants younger than six months to at least 50% using~     a cluster randomised design.~   "
47484|NCT02435511|"~     CommunityRx is a health information technology-based innovation that, starting with the~     patient-health care provider encounter, facilitates self-care coordination for patients,~     caregivers, and providers. The CommunityRx database interfaces with electronic medical~     records to provide patients with a HealtheRx. A HealtheRx is a list of community-based~     self-care resources tailored to the patients health needs (e.g., a person with diabetes~     receives information about podiatrists, nutrition classes, and other resources need to~     manage diabetes). CommunityRx aims to measurably improve health and health care while~     reducing health care costs especially in underserved health care settings. Specifically, the~     proposed research aims to 1) evaluate the impact of CommunityRx on health care utilization,~     cost, health, and patient-centered outcomes for program participants compared to controls;~     2) examine the flow and spread of information to and through primary agents including:~     program participants, community health information experts, healthcare providers, and~     community-based service providers (businesses and organizations providing self-care~     resources); and 3) build and use an agent-based model to test the distributed impact,~     including economic effects, of CommunityRx system adoption on the demonstration area and~     predict performance over time by conducting experiments that vary assumptions about agent,~     environment, and population-level characteristics.~   "
47485|NCT02435498|"~     This study's objectives are as follows:~      1. To evaluate the utility of a website to provide information and guidance about pain~     management in children 2. To educate parents about the pathophysiology of pain, proper use~     of analgesic medications and signs of pain in children 3. To reduce the functional impact of~     pain in children following treatment for fracture 4. To endow parents with confidence to~     manage their child's pain at home 5. To dispel misconceptions about the use and safety of~     analgesics in children 6. To increase awareness of complications of fractures such as~     compartment syndrome~   "
47486|NCT02435485|"~     Background: Patients with degenerative lumbar spondylolisthesis usually are present with low~     back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication,~     insomnia, even urine or stool incontinence. There are very few research on the effectiveness~     of core spine stabilization exercise, balance training, and the balance effect while wearing~     lumbar corset in these patients.~      Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability~     with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic~     spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance~     training and balance effect of the wearing of lumbar corset in patients with degenerative~     lumbar spondylolisthesis .~      Method: Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar~     spondylolisthesis, diagnosed by KUB and lateral radiography of the lumbar-sacral spine in~     neutral, flexion-extension, will be recruited. Among them, seventy patients with~     degenerative lumbar spondylolisthesis will be recruited as experimental group and~     thirty-five patients with lumbar spondylitis will be recruited as control group. Exclusion~     criteria are patient older than 80 years of age, with stroke, spinal cord injury, head~     injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or~     lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment.~      All subjects will receive Visual Analogue Scale (VAS), Oswestry Disability Index, Quebec~     back pain disability scale, and the postural stability test, 75% limits of stability test,~     modified clinical test of sensory integration, and the evaluation of fall risk test of~     Biodex balance system at beginning and at the end of program. Both the control and~     experimental groups will receive rehabilitation training, including hot packing,~     interferential therapy, core spine stabilization exercise and lower extremity strengthening~     exercise for 2-3 times a week, up to 8 weeks, 15 sessions in total. Patients in the~     experimental group will be randomly assigned to either a balance training group or to a~     group without balance training. The balance training will include both weight shift training~     and random control training with Biodex balance system. A balance effect of wearing lumbar~     corset will be evaluated at the beginning of the program. The investigators will follow up~     with these patients by telephone 3 months after program completion.~   "
47487|NCT02435472|"~     The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (home-based~     walking) vs. usual care among 150 men with prostate cancer on active surveillance.~   "
47488|NCT02435459|"~     The aim of this research is to compare the clinical outcome of amalgam restorations placed~     in conjunction with three different lining protocols, each of which represents a different~     therapeutic concept.~   "
47490|NCT02435433|"~     The purpose of this study is to evaluate the safety and efficacy of ramucirumab in~     participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein.~     Participants will be randomized to ramucirumab or placebo in a 2:1 ratio.~   "
47492|NCT02435407|"~     There is a paucity of research evaluating the effectiveness of a multidisciplinary approach~     in an outpatient clinic setting in the management of feeding problems in children diagnosed~     with ASD. Current behavioural interventions geared to address this problem can be labour~     intensive and costly. The SOS approach for managing feeding problems in children has been~     adopted internationally. Thus establishing its effectiveness will be useful in providing~     evidenced based interventions for feeding difficulties in ASD.~   "
47493|NCT02435394|"~     Asthma, one of the most common pediatric illnesses, is optimally managed according to~     National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in~     primary care. This project is to develop and test the effects of using a module for~     guideline based care in the Child Health and Development Interactive System (CHADIS) online~     system by prompting and incorporating patient symptom/control and adherence data from~     standard questionnaires to inform visits and providing automated patient specific education~     and Asthma Action Plans in individual Care Portals.~   "
47494|NCT02435381|"~     The purpose of this study is to determine the effects of treatment with carisbamate compared~     to treatment with placebo, on alcohol-induced stimulant and subjective effects in~     non-treatment seeking alcohol-dependent human volunteers.~   "
47495|NCT02435368|"~     To determine the mechanisms and significances of synergistic effects of mycophenolic acid~     and LPS on IL-1β secretion by mononuclear~   "
47496|NCT02435355|"~     Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for~     moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the~     treatment appears to be a key factor to improving health status of these patients.~      Methods: The investigators conducted a multicenter, prospective, randomized, controlled,~     parallel group trial of standard support completed or not within 3 months of coaching~     sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session~     consisted of 5 sessions of telephone-based counseling by competent staff. The primary~     outcome was the proportion of patients using CPAP more than 3 hours per night for 4 months;~     the secondary outcome was mean hours of CPAP usage in the 2 groups.~   "
47497|NCT02435342|"~     The primary purpose of this study is to examine safety outcomes in active plaque psoriasis~     patients after systemic administration of dalazatide. Clinical outcome measures will also be~     assessed.~   "
47498|NCT02435329|"~     This study is part of a research project for a University MD Program. This is an~     observational study aimed at comparing the differences in bone metabolism and~     microcirculation in patients with type 2 diabetes mellitus (with and without diabetic~     neuropathy and Charcot foot) with healthy subjects.~      Diabetes is gradually becoming a global epidemic along with its associated complications.~     Diabetes can affect several systems in our body particularly the eyes, nerves and the~     kidneys. The damaging effects occur at the level of the small blood vessels~     (microcirculation) that supply these vital structures. Normally, the inner lining of these~     blood vessels (endothelium) plays a very important role in maintaining adequate blood flow.~     The endothelium releases a chemical substance called nitric oxide, which relaxes these small~     blood vessels thereby ensuring sufficient blood supply to these key structures. Nitric oxide~     also prevents blockage of these vessels. Any form of metabolic stress like hyperglycaemia~     (raised blood sugar as seen in diabetes) can cause abnormal changes in the normal behaviour~     of the endothelium (endothelial dysfunction). Therefore hyperglycaemia promotes endothelial~     dysfunction by lowering nitric oxide levels, which may lead to diabetic complications like~     diabetic retinopathy (eye damage), nephropathy (kidney damage) or neuropathy (nerve damage).~      In addition, patients with diabetes also suffer from osteoporosis (thinning of bones).~     Osteoporosis is a bone disorder characterised by a reduction in bone mineral content leading~     to an increased risk of developing fractures. The increased risk of fractures in patients~     with type 2 diabetes is attributed to poor bone quality resulting from the harmful effects~     of high blood glucose. Studies have also shown that nitric oxide has a bone protective~     effect as demonstrated by its ability to prevent bone fragmentation and improve bone~     strength.~      Study of markers of endothelial function and bone metabolism will facilitate a better~     understanding about the origin of diabetic complications. This will aid in the development~     of novel therapeutic agents that target the harmful triggers in diabetes and eventually may~     prevent and retard the onset of the debilitating diabetic complications.~   "
47499|NCT02435316|"~     This is a prospective, randomized controlled, crossover trial comparing the effectiveness~     one two curricular designs to teaching peripheral blood smears to residents.~   "
47500|NCT02435303|"~     The purpose of this study is to determine whether Sildenafil is effective in the treatment~     of sustained pulmonary artery hypertension after corrected mitral valve disease.~   "
47501|NCT02435290|"~     It is a cross-sectional study examining a random sample of in- and out-patients, with proven~     malignant disease receiving chemotherapy, over a period of 6 months from the start of the~     study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect~     of some risk factors on the prescribing error will be studied; these risk factors include~     the following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type~     of anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the~     number of drugs in the treatment regimen , the number of side effects after chemotherapy~     administration, the age of patient ,the dosing frequency of anticancer ,the route of~     administration .~      Summary statistics are performed to describe patient characteristics , frequency, types and~     classification of medication error; and frequency with which Medication errors occur.~      Logistic regression will be applied to the collected data to perform a predictive relation~     between the risk factors which may be (categorical, continuous, or discrete) and the~     prescribing errors which are (categorical).~   "
47502|NCT02435277|"~     Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer~     term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin~     combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects~     with type 2 diabetes using HbA1c as the primary endpoint.~   "
47503|NCT02435264|"~     Recent national statistics revealed that the prevalence of lifestyle related diseases is~     increasing in Singapore. Much of this disease burden can be prevented using lifestyle~     strategies. A large proportion of Singaporeans consume foods prepared by outside vendors.~     These foods are typically high in refined-grains and saturated fat, and choices for~     healthier foods like brown-rice often do not exist. The Healthier Dining Program managed by~     the Health Promotion Board of Singapore, seeks to assess if increasing the availability of~     healthier food options increases consumer consumption of these foods. The investigators aim~     to evaluate this program implemented on the National University of Singapore campus. A major~     output of this evaluation will be the assessment of the barriers and enablers to programme~     implementation which will provide guidance for the widespread implementation of the~     programme. Additionally this evaluation can lead to detailed recommendations on policies and~     programmes relevant to non-home food environments. This is important as successful~     interventions have the potential of improving the eating behaviors of a vast majority of the~     population.~   "
47505|NCT02435238|"~     Non interventional study collecting patient reported outcomes. The study aims to assess the~     disease burden of chronic urticaria patients and to record the therapies used in daily~     clinical practice in the UK and the impact they have on the quality of life and work~     productivity of individual patients.~   "
47506|NCT02435225|"~     The investigators propose to study 30 adolescents with bipolar disorder, not otherwise~     specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI~     (functional magnetic resonance imaging) and functional connectivity (FC) analyses and~     compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched~     healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress~     reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and~     scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This~     proposal will be a natural progression of past research, while extending the investigators'~     expertise to include advanced FC analyses and mindfulness based interventions in youth with~     mood dysregulation. The investigators will also integrate trainees into the imaging and~     therapy components of this study, furthering our mission of mentoring the next generation of~     innovative researchers who will push the field forward.~   "
47507|NCT02435212|"~     This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment~     compliance and change in serum ferritin of a deferasirox granule formulation and a~     deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment~     with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to~     demonstrate the effect of improved compliance on iron burden.~      Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior~     iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core~     phase where patients will be randomized to a 48 week treatment period to either Deferasirox~     DT or granules, and an optional extension phase where all patients will receive the granules~     up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or~     express the wish to continue in the optional extension phase on granules, will be offered~     this possibility until there is local access to the new formulation (granules or FCT) or up~     to 5 years, whichever occurs first.~   "
47508|NCT02435199|"~     The study consists of two periods, the Screening Period (~3 weeks) and Treatment Period (12~     weeks).~      Eligibility for the study will be determined by Screening tests, physical~     examination/medical history, and fulfilment of eligibility criteria including assessment of~     pain completed during the Screening Period. Potential participants will be required to~     provide written informed consent prior to any study-specific Screening procedures being~     performed.~      Following Screening assessments, patients will be randomized to receive either EMA401 300 mg~     BID or placebo.~      Patient study visits during the Treatment Period are at the end of baseline/randomization~     visit, and end of Weeks 3, 6, 9, and 12, for assessments.~   "
47509|NCT02435186|"~     The study objective is to investigate the efficacy and safety of p53 combined with~     chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer,~     Fallopian Tube Cancer, and Primary Peritoneal Cancer.~   "
47510|NCT02435173|"~     This study is designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with~     genetically activated PI3Kδ, i.e., patients with APDS/PASLI. The study consists of two~     parts. Part I is the open label part designed to establish the safety and pharmacokinetics~     of CDZ173 in the target population, as well as to select the optimal dose to be tested in~     part II. Part II is designed to assess efficacy and safety of CDZ173 in this population.~   "
47511|NCT02435160|"~     The aim of our study is to investigate the efficacy and mechanism in fecal microbiota~     transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC)~     patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT)~     treatment,the safety and efficacy of FMT will be observed.~   "
47512|NCT02435147|"~     The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis~     treatment in a real-world clinical practice setting. We hypothesize that continued therapy~     (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength~     index (FSI) and reduce fracture and other bone health risks among post-menopausal women with~     osteoporosis.~   "
47513|NCT02435134|"~     Hip internal rotation range of motion (HIRROM) assessment is performed to assess the~     mobility of the hip. The assessment is typically done manually (manual testing), which~     induces large variability in the results between and within testers. An initial version of~     an examination chair (EC1) was recently developed with the aim to minimize the variability~     of testing results for HIRROM assessments. A new version of the examination chair (EC2) has~     been implemented in order to individualize the testing protocol and will be validated in~     this study.~   "
47514|NCT02435121|"~     Primary Objective:~      To determine objective response rate (ORR).~      Secondary Objectives:~      To assess duration of response (DR), progression free survival (PFS) and overall survival~     (OS).~      To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical~     utility of fluorescence in situ hybridization (FISH) assay in selection of patients with~     mesenchymal-epithelial hybridization (MET) gene amplification.~      To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.~   "
47515|NCT02435108|"~     This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.~   "
47527|NCT02434952|"~     In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less~     effective. The investigators can help to try to prevent the spread of this resistant malaria~     by adding a drug that will make it more difficult for the mosquito to drink up the malaria~     in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot~     develop in the mosquito so it will not be able to inject malaria back into people when it~     bites. The drug the investigators will use is called primaquine.~      Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red~     cells need enzymes to work properly and weak red cells have low amounts of an enzyme called~     glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria~     with primaquine will be safe for the red cells. To do this study, the investigators need to~     know if a subject has low G6PD or not.~   "
47516|NCT02435095|"~     Continuation of antipsychotic drug treatment for at least 12 months after remission of the~     first psychotic episode represents the gold clinical standard, and it is recommended by all~     international treatment guidelines. Numerous studies have shown that the risk of relapse is~     significantly increased, if drug treatment is terminated prematurely. However, only a~     minority of patients achieve functional remission, even if they fully comply with treatment.~     Long-term adverse effects of the currently available drugs, specifically brain grey matter~     loss and development of supersensitivity psychosis, might outweigh their benefits. Thus, the~     current standard of long-term maintenance antipsychotic treatment, which has the primary~     goal of relapse prevention, has to be questioned. Here the investigators hypothesise that~     intermittent antipsychotic treatment (targeted exclusively at positive symptoms) initiated~     after the first psychotic episode is associated with less regional and global brain (grey~     matter) volume loss over a period of twelve months than continuous antipsychotic treatment.~     Furthermore, the investigators hypothesise that this targeted treatment approach is~     associated with better functional outcome (fewer negative symptoms, better cognitive~     performance, better quality of life) than continuous antipsychotic treatment,although the~     latter is initially associated with fewer relapses.~   "
47517|NCT02435082|"~     The objective of this patient registry is to collect and analyze physiological data~     associated with baseline and brain injury identified in standard clinical practice (Normal~     Values, Recovery Curves, Correlation between Symptoms and Other Tests, NCI Index), and to~     assess health economics.~   "
47518|NCT02435069|"~     There is a surgical procedure to help children with intractable fecal incontinence gain~     continence for stool through construction of a tube that connects the abdominal wall to the~     colon near or through the appendix. This tube allows easy administration of enema solution~     into the first part of the colon. Putting enema solution through that tube into the colon is~     called an antegrade continence enema or ACE and has been shown to work well in helping some~     but not all children prevent stool accidents. The purpose of this study is to compare a~     large volume ACE flush using a salt water solution called normal saline with a small volume~     ACE flush using liquid glycerin. The aims of this study are to: 1) find the most effective~     dose and flush frequency of each solution; 2) compare which solution given at the best dose~     takes the least amount of time to clear the colon of stool, has the least side effects, and~     is the most effective in preventing stool accidents; and 3) to determine if administration~     of either of the ACE flushing solution affects colon health and the bacteria in the colon.~   "
47519|NCT02435056|"~     Appropriate delivery of quality healthcare requires constant monitoring of the patient~     during follow up, particularly in the presence of chronic diseases. This approach can be~     further improved if leading edge tools supporting diagnosis, as well as prediction,~     identification and monitoring of adverse events are available. COMOESTAS aims to develop an~     innovative Information Communications Technology (ICT) system that allows patients with a~     chronic condition to receive continuous and personalized treatment. The whole system is~     based on an advanced, all in one Alerting and Decision Support System that follows~     patients from the diagnosis and supports the physician in managing the therapy, controlling~     relevant events impacting on patient safety and activating specific procedures if selected~     thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse~     Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but~     its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a~     disorder that can benefit from an ICT-assisted approach developing innovative systems and~     services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving~     and integrating the traditional paper headache diaries and calendars into an innovative ICT~     tool taking into account the complex issues that accompany this peculiar form of headache,~     which will make the patient a key node in the entire process.~   "
47520|NCT02435043|"~     The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on~     to standard management, could influence post-stroke fatigue (primary outcome), depression,~     work ability or functional outcome (secondary outcomes), compared to controls.~   "
47521|NCT02435030|"~     This is a prospective non-therapeutic observational study in NP-C patients. The aim is to~     characterize the individual patient disease progression profile through the historical and 6~     months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of~     life data.~      Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of~     the study.~   "
47522|NCT02435017|"~     Overall study design is to review National Health and Nutrition Examination Survey (NHANES)~     data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed~     to review the association of nutrients and overall dietary intake compared to biomarkers~     available in NHANES during this period.~   "
47523|NCT02435004|"~     A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the~     ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in~     patients with small fiber neuropathy (SFN).~   "
47524|NCT02434991|"~     This study is being done to assess the esophageal muscle (swallowing tube) in patients with~     and without achalasia to further understand and help direct the treatment for patients with~     achalasia.~   "
47525|NCT02434978|"~     The present study is a randomized controlled trial (RCT) that examines if the outcome of~     peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.~   "
47526|NCT02434965|"~     The purpose of this study is to investigate the safety and effectiveness of autologous human~     placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates~     with severe hypoxic-ischemic encephalopathy.~   "
47528|NCT02434939|"~     This clinical trial will inform of the role of Low dose ketamine in the acute treatment of~     severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary~     aim is to determine whether Low dose ketamine is non inferior to morphine in the management~     of acute painful sickle cell crises. The specific objectives will be to determine the~     maximal change in NRS pain score following administration of ketamine and to examine the~     safety profile of ketamine compared to morphine in this population.~      The investigators hypothesize that low dose ketamine will result in similar effective pain~     control as morphine alone and will not be associated with an increase in adverse events.~   "
47529|NCT02434926|"~     Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several~     congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser~     ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in~     congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber~     instruments into the amniotic cavity under ultrasound guidance. This procedure can be~     successfully done under either general anesthesia, regional anesthesia or local anesthesia~     with sedation. Each technique has both advantages and drawbacks.~      Several complications related to anesthetic after fetoscopic surgery can occur. For~     instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid~     absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension~     intraoperatively can arise from spinal anesthesia.~      The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the~     tertiary care institute (Siriraj hospital) and incidence of complications which may relate~     to different anesthetic techniques.~   "
47530|NCT02434913|"~     This surgery involves the use of a finger joint replacement device for treatment of patients~     with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who~     expect to place their hands in heavy loading situations, or patients needing revision of a~     failed implant placed in the PIP joint. A joint replacement surgery is an operation where~     the arthritic joint is removed and a metal and plastic joint is inserted to replace the~     natural joint. The surgery is expected to last about 2 hours. The procedure is done in the~     operating room and requires general anesthesia or an axillary block. (General anesthesia~     affects the entire body and is accompanied by a loss of consciousness. An axillary block~     results in anesthesia of the hand and forearm only. A tourniquet is applied to the arm to~     prevent bleeding during the surgery.)~   "
47531|NCT02434900|"~     The Vitamin D and Angiogenic Marker Study 1:~      Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to~     early-pregnancy miscarriage~   "
47532|NCT02434887|"~     The purpose of this study is to verify the effectiveness of the investigational product~     through Subjective Assessment and answered by volunteers.~   "
47533|NCT02434874|"~     The purpose of this pivotal study is to illustrate the safety and effectiveness of the~     StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge~     incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92~     subjects will receive a StimGuard SNS System.~   "
47534|NCT02434861|"~     The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and~     its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP~     substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy~     adult population.~   "
47535|NCT02434848|"~     Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in~     HIV-infected individuals, including more rapid progression to cirrhosis and associated~     complications such as hepatocellular carcinoma. For this reason, as well as the shared~     routes of transmission between the two viruses, UK and International guidance recommends~     that all HBV-negative HIV-infected individuals be offered vaccination against HBV.~     Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard~     vaccination courses. To improve this response, strategies such as the use of double dose of~     standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous~     non-responders, although there is currently limited evidence for this approach. An~     alternative strategy is to use vaccines with novel adjuvants such as Fendrix and~     observational clinical data in the Investigators HIV cohort suggests that response rates can~     be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a~     group that did not respond to previous standard HBV vaccine courses. However, the cost of~     Fendrix is considerably higher than Engerix B and controlled trials are required to confirm~     whether this approach is warranted. Furthermore, insights into the potential mechanisms by~     which Fendrix may elicit better responses would be valuable in optimising future vaccine~     strategies in this population.~      The Investigators propose to conduct a randomised, open label, active-controlled pilot study~     comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV~     vaccine courses, which will provide the necessary data to design and power a larger~     multicentre randomised controlled trial. Outcome measures will include the proportion of~     individuals seroconverting with HBsAb levels >100 following each vaccination course, the~     magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and~     the durability of the HBsAb response at 1 year following the end of vaccination.~   "
47536|NCT02434835|"~     The purpose of this study is to evaluate the absorption, metabolism and excretion following~     a single oral dose of [14C]KWA-0711 to healthy male subjects.~   "
47537|NCT02434822|"~     The aim of the study is to generate safety and immunogenicity data with Shanchol in The~     Philippines~      Objectives:~        -  To describe the safety after each dose of Shanchol vaccine.~        -  To describe the immunogenicity after each dose of Shanchol vaccine.~   "
47538|NCT02434809|"~     The first purpose of this study is to test a new computer program that reduces the blurring~     in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators~     want to find out what effects, good and/or bad, that this has on the patient and the way we~     treat the cancer in the lungs.~      The second purpose of this study is to test how well this computer program tracks markers in~     the images, compared to using radio signals to follow the markers.~   "
47539|NCT02434796|"~     Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has~     detrimental effects on mental and physical health including an increased risk of HIV~     infection. The investigators will use a cluster randomized control study design to conduct a~     preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable~     attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine~     villages will be randomly assigned into one of three study arms, each comprised of 150~     partnered women and their co-resident male partners. Women in the comparison arm are~     currently exposed to World Education's savings and lending group intervention (known as~     LIMCA), in which they receive training on business skills, literacy, child nutrition and~     health, child protection, intimate partner violence (IPV) and HIV prevention. Women in~     Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in~     male peer group workshops that explore gender norms, IPV and HIV prevention issues. In~     Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and~     participate in community dialogues with community leaders to explore similar topics as the~     male peer groups. Our hypothesis is that study participants in Arm 2 will report improved~     gender equitable attitudes and lower intolerance of intimate partner violence than~     participants in Arm 1 and participants in the control group. Data will be collected at~     baseline and endline using a structured questionnaire with questions from three validated~     instruments that measure gender equitable attitudes and attitudes about IPV.~   "
47540|NCT02434783|"~     Current evidence cannot explain the clinical features of peripheral arterial disease only~     from the principle of reduced blood flow. Explanations have therefore in addition been~     linked to mitochondrial dysfunction of skeletal muscles.~      This study will elucidate whether there is a relation between clinical variables of the~     different levels of arterial insufficiency in peripheral arterial disease and mitochondrial~     respiratory capacity.~   "
47541|NCT02434770|"~     The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV)~     manufactured by Beijing TiantanBio has a similar immunogenicity profile to a WHO~     pre-qualified bOPV.~   "
47542|NCT02434757|"~     This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy~     in patients with active rheumatoid arthritis (RA) who have had an inadequate response to~     disease modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in~     adequate response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus~     C-Reactive Protein (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times~     the upper limit of normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone.~     This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4~     university/medical centers and private practice settings in the US. A total of 20 eligible~     patients will be enrolled and other standard RA therapeutic agents, such as Methotrexate,~     DMARDs, non-steroidal anti-inflammatory drugs (NSAIDs), pain medications and others will not~     be discontinued. The primary endpoint will be the percentage of patients with reduction of~     ≥1.2 points of the Disease Activity Score in 28 joints (DAS-28) score.~   "
47543|NCT02434744|"~     This study will compare the safety, tolerability and efficacy of the combination of KD026~     and metformin compared to placebo and metformin on improving glycemic control in patients~     with type 2 diabetes mellitus.~   "
47544|NCT02434731|"~     Needle procedures are the most common and important source of pain and distress in children~     in the health care setting. Children with intellectual disability from any cause experience~     pain more frequently than healthy children. They often require venipuncture or IV~     cannulation for diagnostic or therapeutic procedures. Pain in this population is often~     unrecognised because these patients are frequently unable to self-report their pain. Now~     it's possible to measure pain in children with intellectual disability with specific pain~     scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).~      The efficacy of a device combining vibration and cold for pain relief during venipuncture or~     IV cannulation has been recently reported in children. The device's actions are based on the~     Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory~     neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be~     useful in this kind of patients in emergency department. To date, there is no study that~     validated Buzzy device for pain relief in children with intellectual disability.~      The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold~     and vibration), in reducing the pain during venipuncture or IV cannulation, in children with~     intellectual disability.~   "
47545|NCT02434718|"~     The primary objective of the study is to evaluate the safety and tolerability of single and~     multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to~     moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To~     evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous~     (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of~     Aducanumab on immunogenicity.~   "
47546|NCT02434705|"~     The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic~     esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it~     starts an chronic allergy-based inflammation. This will be analyzed with the esophageal~     biopsies and the mucosal impedance probe.~   "
47547|NCT02434692|"~     The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system~     in patients with POAG and indicated cataract surgery.~   "
47548|NCT02434679|"~     Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are~     increasing. Among the actions to control resistance, one is an interesting lead: to prevent~     the emergence of resistant bacteria by limiting possibilities for bacteria to acquire~     resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few~     data on the dynamic of acquisition over time. Among the genetic components that disseminate~     resistance genes, resistance integrons (RI) play a major role in the acquisition and~     dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the~     newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the~     first days of life. It thus appears to be an appropriate model to study the dynamic of~     resistance acquisition. This project intends to follow the NB of neonatology over time in~     order to study the dynamic of the digestive acquisition of RI and MRB~   "
47549|NCT02434666|"~     This is a long-term-safety roll-over extension study for a Phase II Study (Protocol~     CPC-001-07).~   "
47550|NCT02434653|"~     Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms~     versus screening of women at increased risk for post-partum anemia.~   "
47551|NCT02434640|"~     The objective of this trial is to investigate the safety and tolerability of BAY1128688 and~     to determine the concentration of this substance in blood after repeated administration by~     the oral route. The investigational substance will be administered in tablet form to healthy~     women.~   "
47552|NCT02434627|"~     The investigators' previous work in males with Becker Muscular Dystrophy shows that~     functional sympatholysis is restored by acute inorganic nitrate supplementation. This was~     translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown~     that there is a frank improvement in grip strength when mdx mice are treated with an~     inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic~     treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond~     blood flow regulation.~   "
47564|NCT02434471|"~     The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and~     compare the image quality of respiratory triggered 3D T1-weighted images against~     conventional breath hold images.~   "
47565|NCT02434458|"~     The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small~     fiber nerve function, specifically those of the sudomotor, in patients with autoimmune~     disorders (i.e fibromyalgia and rheumatoid arthritis).~   "
47553|NCT02434614|"~     Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy~     was superior to radiotherapy alone in the treatment of locoregionally advanced~     nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy~     (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally~     advanced NPC. However, most of these evidences of standard treatment for locoregionally~     advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the~     intensity-modulated radiation therapy (IMRT) technique has been widely used in the last~     decades, IMRT improved the treatment outcomes of patients with NPC, especially the local~     control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus~     concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve~     survival rates for patients with locoregionally advanced disease, but increased the severity~     of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose~     this randomized phase III non-inferiority study to reassess the efficacy and contribution of~     concurrent chemotherapy in locoregionally advanced NPC during IMRT era.~   "
47554|NCT02434601|"~     The surface of non-carious cervical lesions (LCNC) is a challenge to adhesive systems, it~     presents a dentin layer sclera hypermineralized, presence of bacteria and lack of mechanical~     retention, so this study aimed to evaluate the influence of different surface treatments on~     LCNC through a randomized clinical trial. Patients with LCNC were referred to the study and~     selected according to the inclusion criteria, such as the presence of at least 3 LCNC. Three~     different types of surface treatment were carried out in LCNC: control group, 15 seconds of~     etching dentin; Group I, acid etching of dentin in 30 seconds; and group II, cavity~     prophylaxis with ultrasound for 30 seconds. The remaining steps of the adhesive and~     restorative procedure was the same for all groups, following the material manufacturer's~     recommendations. Evaluations of restorations will be carried out in periods of one week~     (baseline), six months, one year, two years and three years as of tooth sensitivity,~     integrity and color change. Data will be analyzed by McNemar and chi-square test.~   "
47555|NCT02434588|"~     During cataract surgery, it is necessary to dilate the iris in order to remove the~     crystalline lens and position the implant. The diameter of the optical implant being 6 mm,~     in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.~      At pre-operative consultation, the iris is always dilated by instillation of eye drops and~     measured at the slitlamp. For patients with an inadequate dilation, the intervention~     requires the use of a mechanical dilatation device.~      This study aims to assess the value of an alternative dilatation ring to Malyugin ring,~     which can be inserted and removed through an incision of less than 2 mm in diameter, due to~     its size smaller than that of the Malyugin ring.~      Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation~     during surgery, enabling implant placement in good conditions.~   "
47556|NCT02434575|"~     This registry study enables us to collect data on the treatment of LUTS using prostate~     artery embolisation (PAE), and other surgical methods to answer the following questions~     posed by NICE in 2013:~        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?~        -  How does PAE compare with conventional surgical treatments? This will primarily be a~          surgical procedure called transurethral resection of the prostate (TURP) (see below).~        -  Which patients would most benefit from PAE over the other treatment options?~   "
47557|NCT02434562|"~     This is a prospective biobank set up to collect serum from patients with disorders~     associated with changes in androgens, estrogens or sex hormone-binding globulin (SHBG),~     before and/or after treatment.~   "
47558|NCT02434549|"~     The purpose of this double-blinded, placebo-controlled study is to test if treatment with~     Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with~     spastic cerebral palsy.~   "
47559|NCT02434536|"~     Objectives: To estimate the rate of appropriate hospital admissions , and of discharge to~     home episodes that would have been appropriate admissions to the hospital, on patients with~     exacerbations of their COPD by using appropriateness explicit criteria developed with the~     RAND appropriateness methodology. To evaluate the validity of those criteria by looking at~     their correlation with morbid-mortality, use of medications and health resources. To~     identify the variability in the appropriateness admission/discharge among the different~     centres participating on the study.~      Methodology: Prospective observational cohort study. 1. The investigators will apply the~     previously developed explicit criteria to a sample of COPD exacerbations presented in each~     of the Emergency Department of each participating hospital (16 centres). 2. The~     investigators will evaluate if there is variability among centres by comparing their~     appropriateness rates. 3. To study the validity of the criteria, on those admitted the~     investigators will collect information on their evolution (length of stay, need of~     medication, quality of life), complications, vital status during their admission until~     discharge, and up to 2 months after the visit to the Emergency Department the vital status,~     complications, readmissions and quality of life. On those discharged to home from the~     Emergency Department, the investigators will check the presence of complications, vital~     status, readmissions and quality of life. People trained will collect all the needed~     information, in the Emergency Department, during their admission, or by personal interview~     to all discharged to home and to all at 2 months after the visit to the Emergency~     Department.~   "
47560|NCT02434523|"~     The study will compare the effectiveness of amitriptyline versus placebo (inactive~     medication) in treating chronic laryngitis.~   "
47561|NCT02434510|"~     The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine~     gluconate to the splash basin in reducing bacterial growth from splash basins at the end of~     a total joint replacement procedure.~      Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at~     the end of elective total joint arthroplasty cases.~      Null Hypothesis: There will be no difference in bacterial growth from the splash basin at~     the end of the case despite the addition of an antimicrobial solution.~   "
47562|NCT02434497|"~     The purpose of the study is to evaluate the safety of Rosuvastatin in Children and~     Adolescents with Homozygous Familial Hypercholesterolemia.~   "
47563|NCT02434484|"~     This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The~     main objective is to obtain safety information related to Symbenda treatment from clinical~     practice.~   "
47566|NCT02434445|"~     This study investigated the use of novel plasma and urinary biomarkers to predicte the~     development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers~     investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA,~     plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced~     cirrhotic patients who have or have not developed hepatorenal syndrome and compared between~     the two groups. These biomarkers will also be correlated with the occurence of hepatorenal~     syndrome.~   "
47567|NCT02434432|"~     Background: Music therapy has been recommended as an adjuvant therapy for both preterm~     infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and~     has been shown to have some beneficial effects, although conclusive evidence remains~     lacking.~      Objectives: To study the usefulness of two forms of music, as well as no music, on pain and~     physiological and behavioral parameters of preterm infants during a heel stick procedure for~     obtaining blood in the Neonatal Intensive Care Unit (NICU).~      Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal~     behavioral and physiologic responses as compared to infants who hear the lullaby or no~     music.~      Methods: An analytical observational study with a randomized cross-over design will be~     utilized.~      Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal~     hearing. Neonatal Physiologic responses [heart rate (HR), oxygen saturation, (02 sat) and~     respiratory rate(RR)] and Behavioral States will be recorded before and after the heel stick~     procedure. Maternal age, education, and pregnancy complications will be also be documented.~     Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale~     (NPASS).~      Ethical considerations: The study imposes minimal risk on infants. One potential risk is~     that the infant may become agitated while listening to music, especially if it is time for~     feeding. Based on previous research, infants tend to calm down while listening to music.~     However, in the infants who may be hungry or fussy, music exacerbate their agitation. To~     prevent this from occurring the investigators will not perform the heel stick close to~     feeding time and the investigators will be vigilantly timing and monitoring the infant's~     agitation. Because music has been shown to calm infants and stop them from crying, the~     benefits outweigh this risk.~      The heel stick is performed routinely on infants (often 3-6 times a day). The investigators~     will not perform any additional heel sticks for this study, but will rather intervene during~     one of the scheduled heel stick procedures.~   "
47568|NCT02434419|"~     A prospective randomized clinical trial of patients undergoing bariatric surgery.~      Patients were randomly assigned into 3 groups: those patients undergoing percutaneous~     electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1),~     those patients doing the specific training alone (Group 2) and those patients without any~     specific treatment (Group 3).~      The assigned treatment began 15 days after surgery and was maintained during 12 weeks.~   "
47569|NCT02434406|"~     This study examines the feasibility and acceptability of a web-based intervention program~     for women with anxiety after childbirth, potential anxiety reduction after the intervention~     and determines the feasibility of the study design (randomized controlled design) and~     recruitment for the intervention in this population to inform the protocol (including effect~     size and study power) for a randomized controlled trial.~   "
47570|NCT02434393|"~     The purpose of this research study is to characterize the mechanisms contributing to~     cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD).~      This is a non-randomized, observational, non-treatment study. One hundred and twenty (120)~     subjects who meet criteria for Major Depression or LLD will be enrolled for a period of 30~     months. Data from an additional 300 non-depressed subjects will be used from ADNI studies~     for comparison.~      Depression history, symptom severity and health information will be collected at the initial~     psychiatric visit to determine eligibility. A 3 Tesla (3T) Magnetic resonance imaging (MRI)~     scan and florbetapir (18F-AV-45) amyloid imaging will be conducted at the ADNI clinic site~     visits. Collection of plasma and serum for biomarkers, clinical assessments and cognitive~     assessments will be conducted at two time points. Blood samples will also be collected for~     genetic analysis.~   "
47571|NCT02434380|"~     The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the~     aim of this study is to test the hypothesis that a daily equivalent dose of vitamin D of~     3,000 IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and~     neonatal musculoskeletal parameters, specifically knee-heel length at birth and bone mineral~     content at one month of age.~   "
47572|NCT02434367|"~     This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the~     Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to~     usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.~      Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women~     in both arms will complete a number of surveys including questionnaires on fatigue, pain,~     depression, sleep, and social support. In addition, a blood sample will be collected prior~     to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of~     inflammatory biomarkers, and their potential association with exercise and fatigue.~   "
47573|NCT02434354|"~     The main purpose of this trial is to evaluate the safety, tolerability and adverse event~     profile of pembrolizumab in subjects who have high risk melanoma before and after their~     standard of care surgical resection, and to collect tumor tissue from subjects before and~     after receipt of pembrolizumab to look at how the experimental drug interacts with tumor~     tissue. Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete~     resection and then a year of adjuvant pembrolizumab~   "
47574|NCT02434341|"~     15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo~     polysomnographic sleep monitoring up to 24 hours in order to define if there are common~     sleep features within the groups~   "
47575|NCT02434328|"~     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)~     injection to aflibercept solution for IVT injection in subjects with untreated active~     choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in~     the study eye. This study will be conducted in the following countries: Austria, Belgium,~     Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy,~     Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Sweden,~     Switzerland, Taiwan, Turkey, and the United Kingdom.~   "
47576|NCT02434315|"~     The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro~     wear as measured by time in range.~   "
47577|NCT02434302|"~     This is a study to ascertain the number of children with moyamoya in the UK, their~     presenting features, clinical course and outcomes.~   "
47578|NCT02434289|"~     The purpose of this pilot study is to investigate the feasibility and potential impact of a~     combined resistance exercise and increased protein intake intervention in (frail) elderly,~     in a real-life setting.~   "
47579|NCT02434276|"~     This is a multi-center, randomized, double-blind, active comparator controlled study in~     which up to 450 healthy adults age 18-64 years will be administered either one of two dose~     levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be~     randomized at a 1:1:1 ratio.~   "
47580|NCT02434263|"~     The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra~     Aortic valve in real-world patients. Following initial implantation, all patients will have~     clinical follow up at 30 days, 3, months, 6 months and 12 months~   "
47581|NCT02434250|"~     The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a~     prior failed phacoemulsification and Eximer Laser Trabeculectomy.~   "
47582|NCT02434237|"~     Task-oriented repetitive movement can improve movement performance in patients with~     neurological or orthopedic lesions. The application of robotics can serve to assist,~     enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm~     therapy is used in neurological rehabilitation for patients with paralyzed upper extremities~     due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord~     injury. The goal of the therapy is to recover motor function, improve movement coordination,~     learn new motion strategies (trick movements), and/or prevent secondary complications such~     as muscle atrophy, osteoporosis, and spasticity.~   "
47583|NCT02434224|"~     This study investigates whether creative music therapy applied to premature infants will~     facilitate brain growth and development at term equivalent assessed by magnetic resonance~     imaging and electroencephalograhy. Secondary objective are improvement of neurobehavioral~     outcomes of premature infants at 24 months, as well as at 5 years of age.~   "
47584|NCT02434211|"~     The main objective this project is the development of a measurement tool. This consists of~     construct and validate a questionnaire to conduct a quantitative assessment of knowledge and~     individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).~   "
47585|NCT02434198|"~     The primary aim of this study is to investigate the incidence of falling in a cohort of~     patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary~     rehabilitation program and to verify the risk factors. The secondary aim is to verify~     whether available balance assessment tools are feasible in clinical practice and which tools~     and values can best predict falls in people with COPD.~   "
47586|NCT02434185|"~     The bilateral deficit phenomenon (BLD) is defined as an inability of the neuromuscular~     system to generate maximal force when two homonymous limb operate simultaneously (bilateral~     contraction) with respect to the force developed when both limbs acts separately (unilateral~     contraction). From an applied perspective, movement patterns of bilateral homonymous limb~     are often developed during activities of day living, e.g. rising from a chair or opening a~     jar. The BLD can be considered an intrinsic property of the human neuromuscular system but~     could be enough important to constitute a performance-limiting factor for postmenopausal~     women that involves a degenerative loss of muscular strength. Therefore, a specific analysis~     of this phenomenon and its relation with activities of daily living, such as climbing a step~     and rising from a chair, is crucial for detecting variables of neuromuscular performance and~     develop strategies to minimize the loss of strength.~   "
47587|NCT02434172|"~     The study will determine if the initiation of a 'screen and treat' program for cryptococcal~     disease among HIV positive individuals decreases morbidity and mortality among individuals~     with CD4 count < 100 cells/mm3. The study will screen individuals who are asymptomatic for~     CM and are either ART naïve or ART experienced with CD4 count < 100 cells/mm3.~      The introduction of an cheap, easy to use point of care diagnostic test the lateral flow~     assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings.~     The investigators will determine the efficacy of the lateral flow assay in identifying~     latent and asymptomatic cryptococcal disease. The investigators will determine the efficacy~     of the test in detecting disease in readily available body fluids such as urine and whole~     blood obtained via finger-stick method. The investigators will also determine the cost~     effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe.~      The investigators also wish to understand why some individuals with low CD4 counts~     reactivate cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while~     others with similar levels of immunocompromised do not.~   "
47588|NCT02434159|"~     The purpose of this study is to determine if detailed scanning of the heart before~     biventricular device insertion will improve outcomes for heart failure patients.~   "
47589|NCT02434146|"~     This phase I/II trial studies the safety of topical phenylephrine solution and to see how~     well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients~     receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution~     may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and~     total body radiation prior to undergoing a bone marrow transplant.~   "
47590|NCT02434133|"~     The investigators proposed study is the first of its kind. The investigators will measure~     measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the~     current IBD treatment modalities and compare the vaccine antibody concentrations and~     correlate them with time since immunization.~   "
47591|NCT02434120|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one~     (type C) being related to malignant tumors.~      In this study, the investigators will try to see if extrapolation of those data to orbiltal~     tumors is feasible.~   "
47602|NCT02433977|"~     This study will examine the hypothesis that in obese asthmatics with metabolic syndrome;~     treatment with NOx + CLA is well tolerated, safe and will increase eNO while reducing airway~     oxidative stress. Allied with this, the investigators will define whether supplementing with~     this bioactive mediator modifies the airway microbiome, and reduces airway inflammation.~   "
47592|NCT02434107|"~     Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma~     patients carrying a reasonable risk for metastases. In numerous studies the prognostic role~     of micro metastases in the sentinel node (SN) was described. However, the prognostic value~     of a complete lymph node dissection in patients with a positive SN is still unclear.~      This study was planned to analyse the survival outcome of patients with a positive SN~     receiving complete lymphadenectomy versus watchful waiting.~   "
47593|NCT02434094|"~     An e-learning training program is to prepare people with diabetes and their physicians on~     the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).~   "
47594|NCT02434081|"~     Attempts to improve the long-term survival include radiotherapy dose~     escalation/acceleration, new chemotherapy combinations, and adding biological agents and~     cancer vaccines to standard regimens. At present, none of these have demonstrated an~     improved outcome.~      Improved understanding of the immune profile of NSCLC has led to immunotherapeutic~     strategies, including inhibitory molecules responsible for abrogating an anti-cancer immune~     response such as PD-1 and CTLA-4. Bristol-Myers Squibb's nivolumab, an investigational~     monoclonal antibody inhibits the immune checkpoint receptor PD-1 expressed on activated T~     cells.~   "
47595|NCT02434068|"~     Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms~     and additional surgeries. The assessment of residual fragments by imaging is not~     standardized. Computed tomography (CT) is the best way for evaluation of urinary stones,~     however, ionizing radiation from CT is deleterious. The aim of this study is to define which~     patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18~     years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by~     CT will be studied. The clinical evaluation of patients will be held by the same urologist~     in pre-operative consultation, 7 days after the procedure, 30 days after the procedure and~     100 days after the procedure. The assessment of residual fragments will be made through TC,~     ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for~     residual fragments assessment will be compared by Cochran Test and prediction of parameters~     to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant~     level of 5%.~   "
47596|NCT02434055|"~     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during~     angiographic procedures.~      Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast~     delivery modulator designed to reduce unnecessary contrast dye delivery to the patient~     during angiography (coronary or peripheral) and a concomitant system to precisely measure~     contrast volume delivered to the patient. This will be a first in man prospective~     observational study of the accuracy of this system to quantify contract volume used during~     clinically indicated angiography in the cardiac catheterization laboratory.~   "
47597|NCT02434042|"~     This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in~     prevention of acute diarrhea and/or respiratory-related illnesses, which are found common~     among children in Malaysia aged from 2 to 6 years.~   "
47598|NCT02434029|"~     The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide~     effervescent tablets versus placebo for the induction of clinico-pathological remission in~     patients with acute eosinophilic esophagitis.~   "
47599|NCT02434016|"~     Background: Mechanical ventilation is a life saving intervention in patients with acute~     respiratory failure, for instance, due to infection or trauma. The main goals of mechanical~     ventilation are to improve oxygenation and decrease the load imposed on the respiratory~     muscles. Unfortunately, mechanical ventilation comes with adverse events including disuse~     atrophy and weakness of the respiratory muscles. The diaphragm is the main muscle for~     inspiration and therefore this clinical entity is commonly referred to as ventilator-induced~     diaphragm dysfunction (VIDD). Several studies have shown that inspiratory muscle weakness is~     associated with adverse outcomes, including prolonged duration of mechanical ventilation.~     Inactivity or disuse is a recognized risk factor for the development of VIDD: disuse may~     result from excessive unloading of the diaphragm by the ventilator. Therefore, clinicians~     aim to limit the risk of VIDD by using ventilator modes that allow patients to perform at~     least part of the total work of breathing when deemed clinically appropriate. However, even~     when these so-called assisted modes for ventilation are used, excessive unloading of the~     diaphragm may occur; without using technology that allows monitoring of diaphragm function,~     the clinician is often uncertain as to whether this muscle is indeed actively working.~     Continuous recording of the electrical activity of the diaphragm (EAdi) is used to monitor~     diaphragm muscle activity in ICU patients. Furthermore, sonographic measurements of~     diaphragm thickness allows for an easy quantification of diaphragmatic activity (thickening~     fraction) as well as providing a potentially useful mechanism for studying diaphragm injury~     and function during mechanical ventilation.~      Aim: To assess the duration of diaphragm muscle inactivity in patients admitted to the ICU~     using EAdi monitoring and to assess the correlation between diaphragm thicknening fraction,~     as measured by ultrasound, and electrical activity, as measured by EAdi.~      Hypothesis: Diaphragm muscle inactivity frequently occurs in the early phase of ICU~     admission Design: Observational pilot study in ventilated adult ICU patients admitted to the~     ICU at St Michael's Hospital. The investigators aim to enroll 75 patients.~      Primary outcome: Time from catheter positioning to first EAdi (> 5 uV last at least 5~     minutes)~   "
47600|NCT02434003|"~     Scoliosis is a three-dimensional deformity affecting the orientation and position of the~     spine. Locally, the shape of the vertebra is also affected. The most common form is~     adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young~     adolescent females. AIS can either be treated using a brace and in some cases necessitate~     surgical correction to prevent progressive deformity. Risk factors for progression include~     female gender, curve magnitude and location, skeletal maturity and growth velocity. However,~     these risk factors have been shown to be inconsistent in predicting curve progression. Over~     the past 6 years, the investigators have developed a predictive model of the final Cobb~     angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort~     of 195 patients that were enrolled upon their initial visit and followed until maturity.~     This predictive model has a determination coefficient of 0.702. The proposed new study aims~     at refining and testing the external validity of this model in a larger cohort. The next~     step towards using the new model in the clinical setting is to redesign the model and to~     externally validate the model by measuring the agreement between the new method and the~     traditional Cobb angle at maturity in a larger multicenter study. The objective of this~     study is to characterize the risk of scoliosis progression based on local three-dimensional~     vertebral and pelvic measurements present on initial evaluation. Three-dimensional~     reconstructions will be derived from stereo-radiographs acquired with a new biplanar~     low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging,~     Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and~     intervertebral disks at each level as well as the geometry of the pelvis. A series of local~     and regional parameters will then be calculated from these 3D reconstructions. Correlation~     analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse~     plane rotation or pelvic geometry can be used as early predictors of curve progression in~     AIS.~      Identifying a new 3D measure of scoliosis associated with rapid curve progression could help~     predict which curves need early treatment to prevent further progression. The ultimate goal~     of this research project will be to validate this new predictive model and finally transfer~     this new predictive tool in the hands of clinicians treating AIS.~   "
47601|NCT02433990|"~     This research study is to determine the risk factors for acquired heart disease, in adults~     with congenital heart disease. This knowledge is important to develop and target ways to~     prevent or delay the onset of acquired heart disease in adults with congenital heart~     disease.~   "
47603|NCT02433964|"~     The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm)~     with respect to the localized pain and local swelling of ankle sprains in the initial phase.~   "
47606|NCT02433925|"~     Inflammation and oxidative stress are common findings in patients with Chronic Kidney~     Disease (CKD) undergoing conservative treatment, in addition to being associated with~     atherosclerotic process, are related also to the progression of CKD. In this regard,~     resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory~     properties, can play an important role in the control of metabolic disorders associated with~     CKD, since it can modulate the mechanisms involved in inflammation and oxidative stress~     cycle. Resveratrol is capable of promoting the activation of the transcription-related~     factor-2 nuclear factor erythroid factor 2 (Nrf2) , a nuclear factor with anti-inflammatory~     properties, and SIRT-1, a protein also associated with the reduction of inflammation. These~     two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear~     factor κB (NF-kB), a transcription factor that participates in the inflammatory response.~     Although it is a promising treatment, there are no studies evaluating the effects of~     resveratrol supplementation in patients with CKD. Thus, this study aims to evaluate the~     effects of resveratrol supplementation on inflammation and oxidative stress in patients~     undergoing conservative treatment of CKD.~   "
47607|NCT02433912|"~     BACKGROUND: Several procedures have been reported for the surgical correction of gingival~     recession (GR), including the laterally positioned flap (LPF) and the coronally advanced~     flap (CAF), performed as single or two-stage procedures without or with, respectively, the~     preceding placement and healing of a free gingival graft (FGG). The objective of the present~     report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment~     of localized maxillary GR defects.~      METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be~     treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession~     height (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical~     clinical attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score~     (VPS) and bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings~     were performed at baseline, 6 months and 5 years later. Inter-measurements differences were~     analyzed with a Chi-square or a Wilcoxon test, with significance set at α<0.05.~   "
47608|NCT02433899|"~     BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the~     treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully~     employed with the procedure apparently resulting in improved results, however, no previous~     controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed~     as originally described (MACRO). The objective of the present study was to compare the~     clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR.~      METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned~     to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later,~     included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT),~     probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic~     evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed~     with a Chi-square or a paired t-test, with significance set at α<0.05.~   "
47609|NCT02433886|"~     Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional~     treatments (medications or behavior therapy). For some of them, a neurosurgical treatment~     can be indicated. A previous study, employing bilateral double-shot ventral capsular/ventral~     striatal (VC/VS) Gamma capsulotomy (GVC) for OCD has shown that this radiosurgical technique~     is potentially efficacious and relatively safe. However, a few patients may develop~     complications associated to radionecrosis (eg., brain cysts) in a long-term follow-up, which~     are probably associated to lesion volumes. Another study, with the preliminary results of~     smaller VC/VS Gamma capsulotomy lesions has suggested that this procedure is safe and~     remains efficacious. Our aim is to investigate the efficacy and safety profiles of smaller,~     single-shot VC/VS Gamma capsulotomy for OCD. This study will support the development of a~     future double-blind, randomized clinical trial of single-shot VC/VS Gamma capsulotomy.~   "
47610|NCT02433873|"~     The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement~     on gut microbiome, gut health, and body weight. Two formulations of the supplement will be~     evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo.~     Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and~     gut health data will be compared across supplement and placebo groups.~      Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance,~     diversity, and gene function across intervention and placebo groups, and across two doses of~     the intervention.~      Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across~     intervention and placebo groups, and across two doses of the intervention.~      Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across~     intervention and placebo groups, and across two doses of the intervention.~      60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B~     or placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks.~     The supplement is a light syrup liquid. Ingredients that are in the supplement are:~     isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that~     are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose~     will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will~     be instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000~     mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as~     to whether they are receiving placebo or supplement. After screening and once enrolled,~     subject involvement includes visits to George Mason University, being weighed, dropping off~     stool samples, and completing a survey on gut health. Stool samples will be analyzed for~     bacterial DNA. The gut bacterial DNA, weight, and gut health data will be compared across~     supplement and placebo groups.~   "
47611|NCT02433860|"~     There is a significant need for nicotine cessation programs for pregnant women in Spokane~     County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant~     women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end~     of the study, the investigators hope to have three questions answered: 1) what is the quit~     rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by~     pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs~     delivered by other health care providers as documented in the literature? And 3) Does the~     SCRIPT intervention have a significant effect on quit rates for pregnant women compared to~     current Spokane county quit rates? Urine cotinine tests will be used to document smoking~     status before delivery of the SCRIPT program, approximately one week after quit date and at~     >36 wks gestation or at delivery for study participants.~   "
47612|NCT02433847|"~     Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with~     chronic constipation or constipated irritable bowel syndrome.~   "
47613|NCT02433834|"~     A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment,~     Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess~     the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label~     Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent~     Asthma~   "
47614|NCT02433821|"~     The neck pain comes from disturbances related to the cervical spine, of multifactorial~     origin and is considered a frequent problem of disability.~      Pilates is a physical conditioning method that has been widely used to improve posture and~     develop body awareness.~      The aim of this study is to assess the impact of the Pilates method in the control of pain,~     function and quality of life in patients with chronic mechanical neck pain.~      Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into~     two groups: intervention and control. Both groups will be assessed for pain, function,~     quality of life and medication intake.~      The intervention group will hold Pilates sessions for three months, with two sessions per~     week. The control group will continue with the usual drug treatment. Both groups will be~     instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the~     drug will be controlled.~      Although the symptoms of neck pain are common in the population, no study has investigated~     the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is~     that the Pilates method can offer benefits to these patients.~   "
47615|NCT02433808|"~     Patients undergoing surgery often receive paralytic agents (or neuromuscular blocking agents~     (NMBAs)) to facilitate the procedure. At the end of surgery, the effects NMBAs are reversed~     with a drug called neostigmine. The use of neostigmine significantly reduces the risk that a~     patient will be left with muscle weakness in the recovery room. Many anesthesiologists~     routinely use neostigmine because postoperative muscle weakness may lead to adverse events~     after surgery. Other anesthesiologists do not routinely administer neostigmine in the~     operating room because of concerns about potential side effects. Surprisingly, some~     investigators have reported that neostigmine-induced muscle weakness may occur if the drug~     is given when the effects of the NMBAs have completely worn off. In contrast, other~     investigators have not observed this side effect when neostigmine was given at the end of~     surgery. The aim of this study is to determine whether neostigmine use is associated with~     muscle weakness when it is given at the time of nearly complete recovery from NMBAs. Muscle~     strength will be measured using a sensitive monitor (TOF-Watch-SX) and through an~     examination of the patient for evidence of muscle weakness. Patients will also be evaluated~     how they recover from anesthesia and surgery.~   "
47616|NCT02433795|"~     This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in~     patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).~   "
47617|NCT02433782|"~     Designing a treatment protocol using myofascial therapy for the treatment of pain and~     restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.~      Pilot with a small number of patients for assessment the effectiveness and safety of the~     treatment protocol created.~      Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy~     in patients with hemophilia.~      Describe the differences in terms of the dependent variables (range of motion, pain and~     flexibility) in patients with hemophilia who have carried out the treatment.~      Report the relationship between the clinical characteristics of patients and the results~     obtained after the treatment period.~   "
47618|NCT02433769|"~     Muscle relaxants are administered to most patients undergoing general anesthesia in order to~     facilitate the placement of an endotracheal tube and improve operating conditions. Despite~     routine reversal of these agents, many patients arrive in the recovery room with evidence of~     residual muscle weakness. Many studies have demonstrated that residual neuromuscular~     blockade (weakness) is a common occurrence after surgery. The only method of reliably~     detecting the presence of perioperative neuromuscular blockade is through the use of~     quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle~     weakness and display the results on a screen. When using train-of-four (TOF) nerve~     stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be~     displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is~     present, and the endotracheal tube can be safely removed. At the present time, there is only~     one commercially-available stand-alone quantitative monitor available in the United States~     -the TOF-Watch (an acceleromyography device). It is not used by many clinicians because it~     requires experience to obtain accurate results, is expensive, and is subject to interference~     by factors in the operating room. The aim of this investigation is to examine a new~     quantitative monitor, the TOFscan (a new three dimensional acceleromyography device). In~     order to study the accuracy of this new device, the TOFscan will be compared to the current~     clinical gold standard, the TOF-Watch-SX.~   "
47619|NCT02433756|"~     The purpose of this study is to observe the evolution of the CRTD system with left~     quadripolar lead, in terms of electrical parameters in all pacing configurations and to~     evaluate the impact on the clinical outcome.~   "
47620|NCT02433743|"~     A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital~     diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group:~     n=32). Individual dietary intakes were measured and compared to the Recommended Dietary~     Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA),~     hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and~     adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and~     after 9 weeks home-based follow up.~   "
47621|NCT02433730|"~     The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in~     men with low testosterone due to opioid treatment on body composition, the haemostatic~     system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids,~     sexual function and quality of life.~      Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with~     hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40~     patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20~     patients per arm~      A double blinded randomized placebo controlled trial~   "
47641|NCT02433470|"~     In the study the investigators aim to test whether transcranial direct current stimulation~     (tDCS)-induced pain reduction is in association with functional changes in the brain~     measured with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel~     diseases (IBD).~      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in~     patients with chronic inflammatory bowel diseases, which is in association with changes in~     the brain measured via MRI.~   "
47642|NCT02433457|"~     To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292~     P22 tablet.~   "
47622|NCT02433717|"~     Background Paliperidone is an active metabolite of risperidone, both of which are~     antipsychotic agents for treatment of schizophrenia and related psychotic disorders.~     Pharmacogenetic studies have revealed that the efficacy and side effects of antipsychotic~     agents are related to polymorphisms of specific genes, however, there are just a few related~     studies on paliperidone. The current study aims to evaluate whether pharmacogenetic markers~     related to risperidone and genetic markers associated with schizophrenia have effects on the~     clinical effectiveness of paliperidone treatment. The study also uses changes of~     event-related potentials (ERP) as indices for clinical efficacy.~      Methods It is a prospective, open-label, non-randomized and uncontrolled clinical trial to~     study the efficacy and side effects of 6-week paliperidone ER treatment for patients with~     schizophrenia or schizoaffective disorder. The first three weeks of treatment has to be~     inpatient treatment. In the first two weeks, participants will take 9 mg paliperidone ER~     daily. Then the dose of paliperidone can be adjusted to within the range of 6-12 mg per day.~     Efficacy indicators include symptom severity, global functioning, and ERP. Side effect~     indicators include common side effect evaluate, extrapyramidal symptoms, metabolic profiles,~     hormonal change, and bone metabolism indices. Participants will also receive examinations~     for blood drug concentration, genetic polymorphisms, and epigenetic markers.~   "
47623|NCT02433704|"~     To directly compare acute infection rates in patients undergoing total knee replacement with~     intraosseous regional administration or systemic intravenous administration of prophylactic~     antibiotics.~   "
47624|NCT02433691|"~     This pilot study is a first step in a rapidly growing area of clinical research to create~     the most effective means to combat age-related losses in cognitive function through~     preventive lifestyle strategies such as physical exercise and memory training. This study~     will develop innovative simultaneous exercise and memory training programs in non-demented~     volunteers with subjective memory complaints (controls or MCI). Our primary goal is to~     assess the cognitive impact of 4-week memory training programs done twice weekly: 1. during~     simultaneous aerobic exercise (SIM-AR-MET), 2. sequentially after aerobic exercise~     (SEQ-AR-MET), or 3. without aerobic exercise (replaced with sequential stretching and~     toning) (SEQ-ST-MET). The investigators will also measure potential metabolic (e.g.,~     glucose, lipid panel) and molecular (serum BDNF) mediators of observed cognitive changes in~     a subset of participants (those at the UCLA CTRC/IPCN site).~   "
47625|NCT02433678|"~     This is a single center, prospective, randomized, placebo -controlled, parallel design and~     double blind study to evaluate oxidative stress, inflammation and hypertension markers and~     mediators before and after treatment with dapagliflozin.~   "
47626|NCT02433665|"~     1. To determine if a formula derived from PCA using specific patient parameters can be~          used to determine the individual contrast material dose and provide a more consistent~          level of vascular and parenchymal enhancement during MDCT scanning of the abdomen and~          pelvis.~        2. Up to 500 adult patients referred for a CT of the abdomen and pelvis with contrast~          material will be recruited to participate in this trial. Single CT axial slices (n=2)~          will be obtained at the level of the L4 pedicle and the supra-acetabular pelvis using a~          field-of-view that includes all of the patient. From patient measurements (height,~          weight, body dimensions), a customized dose of contrast material will be specified~          according to the derived formula for 400 subjects. One hundred subjects will receive~          the usual fixed contrast dose.~        3. Enhancement data in HU will be measured from the CT scans using manually-placed ROIs on~          the upper abdominal aorta, main portal vein and liver parenchyma, avoiding visible~          liver tumors, major blood vessels and artifacts, if present. This enhancement data will~          be used to determine the patient-to-patient variability.~   "
47627|NCT02433652|"~     Infection with dengue viruses is the leading cause of hospitalization and death in children~     in many tropical Asian countries, and the development of a dengue vaccine is a top health~     priority. This study will evaluate the ability of a single dose of a trivalent dengue~     vaccine to protect against infection with an attenuated candidate DENV-2 vaccine,~     administered 6 months after the trivalent dengue vaccine.~   "
47628|NCT02433639|"~     Biliary tract cancer is relatively rare cancer, with generally poor prognosis. In~     metastatic/recurrent biliary tract cancer, the most commonly used 1st-line chemotherapy is~     gemcitabine+cisplatin combination. However, there is no standard 2nd-line chemotherapy and~     there is no validated targeted therapeutic agent, even though this tumor harbors diverse~     genetic characteristics.~      TH-302 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophos-phate~     is a nitroimidazole-linked prodrug of a brominated version of isophosphoramide mustard~     (Br-IPM). When exposed to hypoxic conditions, TH-302 is reduced at the nitroimadazole site~     of the prodrug by intracellular reductases leading to the release of Br-IPM. Br-IPM can then~     act as a DNA crosslinking agent. In areas of normoxia, TH-302 remains intact as a prodrug~     and toxicity is minimized. In addition, preclinical data suggest that after activation, the~     active moiety may diffuse to areas outside the hypoxic region, demonstrating a bystander~     effect and possibly exhibiting additional anti-tumor activity.~      It is well known that biliary tract cancer is hypovascular tumor, so it contains large~     hypoxic area in the tumor. Therefore it would be worthy to test TH-302 in biliary tract~     cancer.~      This study is a phase II study of TH-302 monotherapy as second-line treatment in advanced~     biliary tract cancer, to investigate efficacy and safety of TH-302 monotherapy.~   "
47629|NCT02433626|"~     Activity of COTI-2 has been demonstrated in the OVCAR-3 ovarian cancer tumor model. With its~     p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in~     treatment of patients with gynecologic malignancies.~      This study is designed primarily to assess the safety and tolerability of COTI-2 in patients~     with advanced and recurrent gynecologic and head and neck malignancies and to establish a~     recommended Phase 2 dose (RP2D) for future studies.~   "
47630|NCT02433613|"~     Prospective, multi-center, single-arm, non-interventional and open-label registry. The~     purpose of the registry is to document use of Phased Radio Frequency Ablation (hereafter~     Phased RFA) System in a real world patient population with atrial fibrillation and~     evaulate its performance.~      Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38~     sites in Western, Central Europe, Israel and South Korea.~   "
47631|NCT02433600|"~     This study is intended to measure declarative or stored memory and behavior between infants~     who consume one of two infant formulas through approximately one year of age.~   "
47633|NCT02433574|"~     Despite improved staging and operative techniques, the rate of incomplete resection (R1) of~     NSCLC has remained significant over the last decades. Patients with R1 resection have~     significantly worse survival compared to those with complete resection (R0).~      This is a phase I study that investigates the feasibility and safety of delivering~     Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1)~     who are at risk for incomplete resection.~      Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate~     adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with~     escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.~      The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery~     (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates~     and secondary surrogates of feasibility.~      If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.~   "
47634|NCT02433561|"~     Continuous interscalene brachial plexus block consists of inserting a catheter directly~     within the brachial plexus in the interscalene groove, between the middle and anterior~     scalene muscles, which is then infused with local anesthetic. This technique provides potent~     and site-specific analgesia for several days after major shoulder surgery, along with~     increased shoulder range of motion. A major side-effect of this procedure is the paralysis~     of the ipsilateral diaphragm, which is the main muscle of the respiration. This paralysis~     occurs at a rate of 90 to 100%, and is due to the spread of the local anesthetic towards the~     phrenic nerve, lying anteriorly to the plexus, between the sternocleidomastoid and anterior~     scalene muscles. Therefore, many patients suffering from respiratory syndromes, such as~     chronic obstructive pulmonary disease, will not have a continuous interscalene brachial~     plexus block, thus forfeiting some, or all, of the aforementioned benefits associated~     regional anesthesia.~      It is conventionally taught to place the needle tip between the nerve roots of the brachial~     plexus to obtain an effective block (intra-plexic injection). Recently, we have published a~     new technique of single-shot injection for interscalene brachial plexus block where the~     needle tip was positioned at a distance of 4 mm of the lateral part of the brachial plexus~     (extra-plexic injection) and resulted in a reduction rate of 70% of hemidiaphragmatic~     paresis and a preservation of spirometric values, while providing similar analgesia, when~     compared to a conventional injection. Contrary to single-shot injections where high volume~     and high concentration of local anesthetics are injected (eg, ropivacaine 0.5%, 20 mLs),~     continuous blocks required low volume and low concentration (eg, ropivacaine 0.1-2%, 2-6~     mLs/h) and therefore the aforementioned concept of extra-plexic technique might not be~     suitable.~      Recently, new catheter-over-the needle (Contiplex® C; B. Braun Melsungen AG, Germany) have~     been released on the market and allows the physician to place the catheter tip exactly where~     he desires, contrary to the previous generations where the catheters were inserted blindly,~     despite the use of ultrasound.~      The first objective of that randomised controlled trial is to demonstrate that an~     extra-plexus catheter placement produces less respiratory complications than an intra-plexus~     catheter placement. The second objective is to confirm that both techniques provide similar~     analgesia.~   "
47635|NCT02433548|"~     Femoral neck fracture is very common in the elderly and can produce severe to moderate pain.~     As this pathology is not life-threatening, waiting time in the emergency department may be~     prolonged due to the high number of unforeseen cases with patients remaining in pain.~      Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca,~     resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves,~     with effective analgesia.~   "
47636|NCT02433535|"~     This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to~     inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation,~     improve lung function and symptoms, and reduce acute exacerbations in patients with severe~     asthma who are already on controller inhaler therapy.~      This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized~     clinical trial, titled Randomized Trial of Simvastatin for the Treatment of Severe Asthma,~     will be conducted at the University of California, Davis Medical Center (UCDMC) in~     Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects~     with severe asthma (as defined by the American Thoracic Society (ATS)), who are already~     taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe~     allergic asthma.~      The investigators hypothesize that treatment with Simvastatin 40 mg (administered once~     daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation,~     but will also reduce acute exacerbations and improve lung function. All patients will be on~     standard controller therapy including appropriate doses of inhaled corticosteroids and~     long-acting bronchodilators.~   "
47637|NCT02433522|"~     MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for~     ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12,~     M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after~     the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of~     MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab~     infusion (unpublished data). Right now, no randomized controlled study has been carried in~     order to evaluate the best duration of the maintenance treatment with rituximab.~      The investigators objective is to evaluate the efficacy of a long term rituximab treatment~     to prevent relapses of ANCA-associated vasculitis in patients in remission after a first~     phase of rituximab maintenance treatment.~      The investigators will conduct a randomized placebo-controlled trial of a long term~     rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18~     months).~   "
47638|NCT02433509|"~     The objective of the study is to determine the safely of Human Umbilical Cord Blood~     mononuclear cells by Intravenous injection in acute ischemic stroke patients.~   "
47639|NCT02433496|"~     This project pilot tests an innovative clinical guideline translation and physician coaching~     model to promote adherence to evidence-based guidelines for the prescribing of opioid pain~     medications in primary care settings.~   "
47640|NCT02433483|"~     Allogeneic transplant can sometimes be an effective treatment for leukemia. In a traditional~     allogeneic transplant, patients receive very high doses of chemotherapy and/or radiation~     therapy, followed by an infusion of their donor's bone marrow or blood stem cells. The~     high-dose chemotherapy drugs and radiation are given to remove the leukemia cells in the~     body. The infusion of the donor's bone marrow or blood stem cells is given to replace the~     diseased bone marrow destroyed by the chemotherapy and/or radiation therapy. However, there~     are risks associated with allogeneic transplant. Many people have life-threatening or even~     fatal complications, like severe infections and a condition called graft-versus-host~     disease, which is caused when cells from the donor attack the normal tissue of the~     transplant patient.~      Recently, several hospitals around the world have been using a different type of allogeneic~     transplant called a microtransplant. In this type of transplant, the donor is usually a~     family member who is not an exact match. In a microtransplant, leukemia patients get lower~     doses of chemotherapy than are used in traditional allogeneic transplants. The chemotherapy~     is followed by an infusion of their donor's peripheral blood stem cells. The objective of~     the microtransplant is to suppress the bone marrow by giving just enough chemotherapy to~     allow the donor cells to temporarily engraft (implant), but only at very low levels. The~     hope is that the donor cells will cause the body to mount an immunologic attack against the~     leukemia, generating a response called the graft-versus-leukemia effect or~     graft-versus-cancer effect, without causing the potentially serious complication of~     graft-versus-host disease.~      With this research study, the investigators hope to find out whether or not~     microtransplantation will be a safe and effective treatment for children, adolescents and~     young adults with relapsed or refractory hematologic malignancies~   "
47658|NCT02433249|"~     The purpose of this pilot study is to develop an intervention, based on empirical evidence~     and health-related behavioral change theory, to enhance motivation for engaging in~     fall-reducing physical activities.~   "
47643|NCT02433444|"~     In this study, the investigators aim to distinguish patients with Post-Endoscopic retrograde~     cholangiopancreatography (ERCP) Pancreatitis (PEP) vs. those without PEP based on difference~     in pre- vs. post-ERCP measurements of AGIS-derived intestinal rates (IR). Based on the~     clinical observation that many patients with PEP develop ileus following ERCP, the~     investigators hypothesize that patients who develop PEP will exhibit lower IR following~     ERCP, and therefore a larger difference in pre- vs. post-ERCP IR.~   "
47644|NCT02433431|"~     The purpose of this study is to test the active components of mindfulness meditation for~     reducing psychological stress and improving biomarkers of health. This study compares the~     effects of three brief trainings: (1) training in both present-moment attention and mindful~     acceptance, (2) training in present-focused attention, and (3) an active psychological~     training with no mindfulness content.~   "
47645|NCT02433418|"~     300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1~     will be offered tubal flushing with water soluble media through hysterosalpingography (HSG)~     and group 2 will receive no intervention~   "
47646|NCT02433405|"~     The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum~     Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal~     health and disease.~   "
47647|NCT02433392|"~     The purpose of this trial is to determine the safety and feasibility of injecting irinotecan~     hydrochloride drug-eluting beads directly into the cavity remaining after a tumor is~     surgically removed in patients with a type of brain tumor (glioblastoma multiforme - also~     known as glioma) that has returned after prior therapy.~   "
47648|NCT02433379|"~     This study assesses the 18-month incidence of inappropriate shocks in subjects implanted~     with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of~     sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp~     in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The~     incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate~     shocks observed in the MADIT RIT study.~   "
47649|NCT02433366|"~     The key focus of this survey will be to collect data on physicians awareness of the content~     of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to~     patients. The data collected with atrial fibrillation patients will show if and how well~     this information is received and understood.~   "
47650|NCT02433353|"~     Approximately 150 active duty service members meeting Diagnostic and Statistical Manual~     version 5 (DSM-5) criteria for posttraumatic stress disorder (PTSD) and scoring 50 or above~     on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited. Qualifying~     participants will be randomized on a 1:1 basis to either the eye movement desensitization~     reprocessing (EMDR) plus venlafaxine XR group or the EMDR plus placebo group. Protocol will~     call for participants to complete 12 one-hour EMDR session while taking a venlafaxine~     XR/placebo dose of 150mg or 225mg for the entire 24 weeks. Both prescribers and therapists~     will be blinded and CAPS-5 assessments will be completed by an individual not involved in a~     participant's direct treatment. An unblinded pharmacist will dispense medication or placebo~     according the instructions of the prescriber and will count remaining tablets to measure~     compliance. All EMDR sessions will be recorded and will be reviewed by the principal~     investigator using a fidelity checklist. CAPS-5 will be administered after completion of~     EMDR and again at 6 months from the date of his/her first therapy session.~   "
47651|NCT02433340|"~     This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the~     safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed~     Study M12-963 Phase 2 RCT.~   "
47652|NCT02433327|"~     Critical illness in the patient and death can potentially be predicted and prevented.~     Deterioration of the clinical condition of hospitalised patients is often preceded by~     physiological changes up to 24 hours before death. Despite this several reports show that~     lack of identification and proper actions in patients developing acute and critical illness~     remains a problem.~      The purpose of this study is to investigate if Paediatric early Warning Score (PEWS)~     optimises identification of acute and critically ill children and prevents life-threatening~     situations. The hypothesis is that implementation of PEWS supported by directions for action~     algorithms for intervention will have an impact on number of unplanned transfers to~     intensive care in already hospitalised children.~      This study is a multi-centre randomised controlled intervention study designed within a~     Complex Intervention framework; the study sheds light on the problem, validation of the data~     collection instrument, testing of the intervention and evaluation. The study involves all~     paediatric departments and some acute departments in Central Denmark Region. The study is~     designed as a randomised controlled intervention study where children are randomised to one~     of two different Paediatric Early Waning Score models.~      Development and implementation of PEWS is expected to contribute to reduce the number of~     children developing acute critical illness, number of admissions to intensive care. PEWS is~     also expected to contribute to increase professional skills and competences in health~     professionals. It is expected that this study will contribute towards working with a joint~     PEWS model in Denmark. Last but not least it must be expected that a PEWS model will~     contribute to reducing the costs for society as an intensive care hospital bed is more~     expensive than a hospital bed at a general paediatric department.~   "
47653|NCT02433314|"~     This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547~     to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a~     continuous intravenous infusion to these subjects~   "
47654|NCT02433301|"~     The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400~     new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease~     (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended~     surgery. The prognosis is poor, with 5-year survival rates of approximately 2 % for these~     60% and the treatment only consists of palliative therapy 1. For the remaining approximately~     40 % who are assessed as candidates for curative intended surgery, the 5-year survival rate~     is 33 % 1. This emphasizes the need for further research and knowledge concerning tumour~     biology and spontaneous course of the disease.~      In Denmark, all cancer patients are enrolled in a specific cancer program. The primary~     diagnostic work-up for GEJ cancers includes gastroscopy with biopsy, blood samples,~     ultrasonography scan, Positronemissionstomography (PET) and Computed tomography (CT) alone~     or PET/CT in combination 2. From these parameters physicians determine resectability and~     TNM-stage (tumour staging), which is substantial for the prognosis and future treatment. The~     primary goal is to achieve a macroscopically resection of tumour and lymphnodes in relation~     to the stomach and oesophagus (Esophagectomi a.m. Ivor Lewis and D1+ lymphadenectomy in the~     abdomen and thorax). In addition to surgery, patients receive perioperative chemotherapy,~     which consist of three series of chemotherapy preoperative and three series postoperative~     approximately 21-28 days after surgery.~      Approximately 12.6 % of patients receiving perioperative chemotherapy prior to surgery will~     have disease progression due to chemotherapy resistance during the therapy 3. This~     unintentionally leads to shifting these patients from the resectable group to non-resectable~     group (palliative treatment). Thus, the possibility for detecting response to perioperative~     chemotherapy is of great interest. A paradigm shift towards an individualised tailored~     therapy form has emerged in recent years, which potentially require a higher need for~     diagnosis on molecular level. Today most molecular biological methods apply tissue samples~     for in-vitro analyses, but new radiological tools provide opportunity for non-invasive~     examinations; for example PET can with a radioactive sugar compound: Flour-18 deoxyglucose~     (18F-FDG). This compound is injected through a catheter in a larger vein (media cubiti vein)~     and absorbed in cells with increased metabolism - especially cancer cells. A PET scanner~     registers the absorption; this radiology modality can provide valid information, which is~     essential for non-invasive tumour staging and monitoring response under a specific therapy.~      A new diagnostic modality is PET scan combinated with magnetic resonance (PET/MR)~     simultaneously. So far, no studies have conducted an evaluation of simultaneous PET/MR scan~     to assess the perioperative chemotherapy response in patients with GEJ cancer. However, some~     studies suggest that commercially available PET/MR scanner might contribute in a diagnostic~     elucidation 6. Simultaneous PET/MR scan might in theory minimize the misinterpretations of~     potential response changes after chemotherapy, which can appear in the interval between~     separate PET, CT and MR scans 4,5,7. Studies have found PET scan of GEJ cancer could be~     helpful as a prognostic tool to differentiate between responders and non-responders during~     chemotherapy 9. Standardized uptake value (SUV) is a unit that display the absorption of~     18F-FDG and is used routinely to quantify tumour glucose metabolism in PET scan 8. A change~     of more than 35 % in SUV measurements before and after the induction of chemotherapy is~     considered as the definition of responders and non-responders in earlier studies 9.~      The MR technique is based on magnetic fields and radio waves. Diffusion Weighted Imaging~     (DWI) is a non-invasive MR-modality, which measures the changes in water diffusion (Brownian~     movements) throughout tissue. These changes are measured in Apparent Diffusion Coefficient~     (ADC), a parameter derived from DWI and reflects the change in diffusion 7. ADC and DWI can~     be used to differentiate between benign and malignant tumours, due to a larger cell density~     in malignant tumours. Consequently, malignant tissue has a decreased diffusion relative to~     normal tissue. ADC has been used as a factor in some studies to predict the response to~     chemotherapy 10. A single study has shown a rise in ADC-value two weeks after initiation of~     chemotherapy in patients with GEJ cancer, and demonstrated that the percentage change in~     ADC-value between the groups (responders and non-responders) is significantly different 11.~     Simultaneous PET- and MR scan might be very useful to evaluate the response to chemotherapy~     in patients with GEJ cancer compared with these parameters alone. The opportunity for a more~     individualised tailored treatment in future might be possible with PET/MR.~   "
47655|NCT02433288|"~     This is a randomized, two-arm, open label, Phase IV clinical trial to evaluate if the~     provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin~     treatment duration.~   "
47656|NCT02433275|"~     CHildhood ASthma and Environment Research study - CHASER study is an observational~     longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of~     Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular~     Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.~      The first phase - transversal study will identify determinants of pediatric asthma control~      The second phase - longitudinal study (2 year follow-up), in patients with persistent~     asthma, will be focused on:~        -  predictors for asthma exacerbations and loss of control~        -  real life adherence to asthma therapy guidelines Chaser Project is expected to improve~          the knowledge of pediatric asthma in patients with different level of control,~          identifying predictors for asthma exacerbations and loss of control.~   "
47657|NCT02433262|"~     Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using~     World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy~     Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia~     Medical Centre (UKMMC)~   "
47659|NCT02433236|"~     Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of~     fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15~     months.~   "
47660|NCT02433223|"~     The purpose of this project is to evaluate hospital utilisation, patient and service~     outcomes of a Respiratory Nursing Service to examine current clinical care of COPD. This~     evaluation aims to identify the important gaps in current clinical care of respiratory~     chronic disease nursing management. The primary outcomes of this evaluation is to determine~     the efficacy of clinical care in 2006, 2011 and 2013 and compare data to current Nursing~     Best practice guidelines for COPD through the quantification of hospital utilisation for~     hospital admission, average length of stay, readmission within 28 days, emergency service~     attendance, outpatient review, use of Hospital and Home (H@H), frequency of exacerbations,~     disease severity and progression (FEV1: GOLD Classification), number of contacts with the~     respiratory nursing service and type of contacts with the respiratory nursing service.~   "
47661|NCT02433210|"~     The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H~     and to compare its performance characteristics and hemocompatibility with those of the~     commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.~      10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood~     samples for several parameters will be collected during hemodialysis to assess the~     performance and hemocompatibility of the dialyzers under study. Data thus collected will be~     analyzed for comparison by standard statistical analysis.~   "
47662|NCT02433197|"~     Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however~     impaired muscle function and fatigue are the most common complications among patients with~     GCC undergoing treatment with chemotherapy. Although exercise is widely recommended,~     information about physiopathological effects of cancer therapy in skeletal muscle is very~     limited.~      Methods/Design: The present study is a randomized controlled trial comparing an~     individualized program of muscular strength and endurance with aerobic training compared to~     a control group. All variables will be measured at the beginning and at the end of a 8-week~     intervention by the same evaluator, who will hide the disposition of participants to each~     group. Besides, it will be monitoring during de following 6 months (24 weeks) after training~     for all outcome variables.~   "
47663|NCT02433184|"~     The main aim of the study is to determine whether TNFi instituted as first-line therapy in~     early RA confers better outcomes (clinical, structural and immunological) compared to~     delayed TNFi start; implying particular dominance of TNF in early disease, a changing role~     of TNF with disease duration and hence, confirmation of a biological window of opportunity.~   "
47664|NCT02433171|"~     The goal of this protocol is to evaluate the potential of PET imaging of amino acid~     transport and microglial activation to improve the differentiation of tumor recurrence and~     radiation necrosis in patients with brain metastases after treatment with stereotactic~     radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be~     used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS)~     and FDG-PET (fluorodeoxyglucose).~   "
47665|NCT02433158|"~     This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have~     completed the double blind Phase 3 study (B5201002).~   "
47666|NCT02433145|"~     The current study using the longitudinal study in preschool children to exam three study~     issues: 1) using the neuropsychological functions (ie. Behavioral inhibition, delay~     aversion, the variability of reaction time) among the preschool children predict the ADHD~     diagnosis and behavior symptoms in 1.5 years later. 2) using the behavior inhibition, delay~     aversion and the variability of reaction time (using the parameter among Gaussian~     distribution and ex-Gaussian distribution) explore the association between attention and~     motor inhibition problems. 3) explore the transaction effect between the neuropsychological~     functions and family function and parenting to predict ADHD comorbidity with oppositional~     defiant disorder.4) explore the association between the internalizing/ externalizing~     problems of ADHD and temperament. The current study has opportunity to describe and to~     answer the complicated problems for heterogeneous neuropsychological deficits in ADHD, and~     to elucidate the core issues for ADHD have comorbid with ODD. The most important~     contribution is to offer the empirical evidence to make a clean suggestion in ADHD diagnosis~     and intervention in preschool age.~   "
47667|NCT02433132|"~     The diagnosis of CF is currently based on the discovery of two CFTR gene mutations and / or~     a positive sweat test (> 60mmol / l). A significant number of patients with atypical cystic~     fibrosis (chronic sino-pulmonary disease with a single mutation in the CFTR gene and / or a~     test of the intermediate sweat between 30 and 60 mmol / l) undetected by these techniques~     are behind specialized care while irreversible lung damage is already existed. Currently,~     the measurement of nasal potential difference in vivo (DPN), which evaluates the~     transportation of chlorine in the nasal epithelium with an electrode, is proposed for the~     diagnosis of atypical forms. However DPN dependent nasal local conditions when analysing do~     not always offer the possibility of concluding the diagnosis of cystic fibrosis. It is~     necessary to develop new and more reliable diagnostic tests for the detection of cases of~     atypical cystic fibrosis. The authors propose to develop a new diagnostic technique based on~     the study of bioelectric properties of a preparation of nasal cells of the subject obtained~     by brushing and placed in primary culture (CCBN).~   "
47668|NCT02433119|"~     A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy~     and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with~     essential hypertension uncontrolled with valsartan 160mg monotherapy~   "
47669|NCT02433106|"~     A randomized control trial examining the effects of an exercise based injury prevention~     programme on postural control and jump landing mechanics. Randomization of 4 teams, 2 Gaelic~     football and 2 hurling teams to exercise intervention and control groups. Participants are~     tested using Y Balance test and Landing Error Scoring System (LESS).~   "
47670|NCT02433093|"~     The study will assess the safety, tolerability, and pharmacokinetics of basimglurant~     compared to placebo after multiple ascending oral doses for up to 22 days in healthy~     subjects and in patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or~     serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.~   "
47778|NCT02431689|"~     Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the~     current study the investigators will attempt to compare antagonist and short protocols~     regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be~     performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still~     implantation and pregnancy rates are considered secondary outcomes.~   "
47671|NCT02433080|"~     Endometrial cancer is the most common gynaecological cancer in developed countries with more~     than 75% of the patients surviving for at least five years. However, most endometrial cancer~     survivors are overweight and obese and do not meet the current nutrition and physical~     activity recommendations. This can lower their quality of life and increase their risk for~     chronic diseases. Behaviour change interventions can help them feel better about themselves~     and improve their quality of life. Applying them shortly after treatment seems ideal as~     cancer survivors feel motivated to make changes about their lifestyle at this time point.~      This study is to see if the investigators can design a project to measure how well a~     psycho-educational healthy eating and physical activity programme tailored to the survivors'~     needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three~     years, and are all clear will be put by chance into one of two groups. One will receive the~     program. The other will receive usual care until the end of the trial and, then, a~     discussion and a self-help guide about eating well and being active following cancer~     treatment. This will help us to see if the programme makes a difference compared with usual~     care. The results will inform a larger study to test if a lifestyle program can improve the~     quality of life of uterine cancer survivors compared with usual care. The investigators will~     change the programme materials in response to the investigators' findings, making them~     available to services. The results will inform practice and research.~   "
47672|NCT02433067|"~     Purpose of the study is to examine the effects of 3 months of physical activity intervention~     on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast~     cancer~   "
47673|NCT02433054|"~     The purpose of this study is to examine patency rates of self-expanding nitinol stents for~     treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or~     stenosis. Moreover, clinical outcome data of patients treated with these venous stents will~     be collected.~   "
47674|NCT02433041|"~     The purpose of this study is to find out whether postoperative delirium can be more properly~     prevented by the combination of determined preventive agents in past studies. Further on the~     investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and~     S-100beta levels.~   "
47675|NCT02433028|"~     The key aims of the Swiss Multiple Sclerosis Cohort-Study (SMSC) are~        1. To maintain a long-term cohort (>10 years) representative of the MS population~          currently living in Switzerland. This requires effective measures to limit drop-outs~          and the continuous recruitment of MS patients and~        2. To conduct a systematic follow-up with standardized, high quality collection of~          clinical and magnetic resonance imaging (MRI) data, as well as body fluids.~      The significant heterogeneity within the diagnostic entity and phenotype of multiple~     sclerosis (MS) is incompletely understood. A central and necessary prerequisite of further~     advance is a sufficient amount of high quality clinical and paraclinical (imaging, body~     fluids) patient data.~      Nested projects will address specific research topics, and facilitate collaboration of the~     most qualified investigators within the group of SMSC investigators. The nested projects~     will focus on the:~        1. Development and validation of diagnostic and prognostic markers of spontaneous disease~          evolution and therapeutic response.~        2. Exploration of the safety and impact on long-term disability of existing and next~          generation MS treatments~        3. Individualized therapy: A number of highly active but potentially also harmful~          therapies have lately been established for the treatment of MS. To date, due to the~          lack of individual prognostic markers patients may not receive aggressive therapy due~          to safety concerns, or patients with benign disease may receive expensive and~          potentially harmful treatments without the need for it.~   "
47676|NCT02433015|"~     The objective of this study is to examine the cognitive, immunological, and~     neurophysiological effects of transitioning from tobacco cigarettes to electronic~     cigarettes. The central hypothesis of this study is that this transition will be accompanied~     by a decrease in peripheral inflammation, which will lead to significant changes in the~     neurocircuitry underlying interoception and appetite.~   "
47677|NCT02433002|"~     The eGFR-C study will assess the accuracy of current and alternative tests of kidney~     function against a reference test in people with moderate (stage 3) chronic kidney disease~     (CKD).~   "
47678|NCT02432989|"~     This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents~     and young adults with concussion in the first week post-injury and (2) to evaluate the~     effects of mild symptoms on brain function using EEG. This pilot study will inform~     subsequent grant applications, and a Phase II randomized control trial that will explore the~     influence of age on an early re-introduction to exercise, as well as the influence of~     varying intensity levels of exercise.~   "
47679|NCT02432976|"~     A diminution of quality of life is often reported by patients after coronary artery bypass~     graft (CABG) surgery. A part of this diminution could be explain by postoperative left~     ventricular (LV) dysfunction.~      Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect~     that depends on the blood glucose level. Recent data have suggested that exenatide could~     improve LV function by an inotropic effect in patients suffering from cardiogenic shock or~     from congestive heart failure. Moreover, patients suffering from congestive heart failure~     reported a better quality of life when they were treated with exenatide compared to placebo.~      The investigators hypothesize that perioperative exenatide infusion could improve~     postoperative quality of life in CABG surgery patients.~   "
47680|NCT02432963|"~     This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating~     patients with solid tumors that have spread to other places in the body and usually cannot~     be cured or controlled with treatment, that have failed prior therapy, and that cannot be~     removed by surgery. Vaccines made from a gene-modified virus may help the body build an~     effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab,~     may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy~     together with pembrolizumab may be a better treatment in patients with solid tumors.~   "
47699|NCT02432716|"~     This study is a single center, randomized, double-blind, placebo-controlled, cross-over~     pilot study designed to assess the safety of intranasally (IN) delivered glulisine versus~     placebo in patients with DS. Subjects will be randomized into this cross-over study and~     within subject comparisons conducted between single treatment of intranasal insulin~     glulisine and single treatment of intranasal placebo. All subjects will also receive a~     single treatment of placebo prior to randomization to ensure adherence to study procedures.~   "
47681|NCT02432950|"~     This pilot clinical trial studies a pancreatic nutritional program for helping patients with~     stage I-III breast cancer who are overweight or obese lose weight. When patients have a high~     level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the~     pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and~     other illnesses. Breast cancer patients who are overweight and obese are more likely to have~     their breast cancer return. The pancreatic nutritional program is a diet and lifestyle~     intervention that helps protect the pancreas by keeping blood sugar levels low, and may help~     patients achieve sustained weight loss, improved health, better quality of life, and~     possibly a better outcome to their treatment.~   "
47682|NCT02432937|"~     The study primarily aims to compare the effects of two doses of Corever with placebo in~     patients with hypertension.~   "
47683|NCT02432924|"~     The primary aim of the study is to examine whether the provision of personalised~     multidimensional physical activity profiles (derived from technological advances in physical~     activity monitoring) is supported by instantaneous physical activity feedback in fostering a~     meaningful change in physical activity behaviour amongst adults.~   "
47684|NCT02432911|"~     This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in~     elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.~   "
47685|NCT02432898|"~     Evaluate the clinical information obtained from the use of the machines.~   "
47686|NCT02432885|"~     This trial intends to evaluate myocardial Fibrosis progression in Duchenne and Becker~     Muscular Dystrophy, as well the influence of ACE inhibitors in fibrosis progression.~     Additionally, this study aims to determine genetic predictors of cardiac involvement in~     these dystrophies.~   "
47687|NCT02432872|"~     The purpose of this study is to determine whether the escalation dosage of Daunorubicin and~     cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid~     leukemia（AML） patients aged 55 to 65 years.~   "
47688|NCT02432859|"~     The purpose of this study is to determine whether electrical stimulation is effective in the~     expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.~   "
47689|NCT02432846|"~     The purpose of this study is to compare tumor response, progression free survival (PFS) and~     overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax pre-nephrectomy~     followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy in non-vaccinated~     patients.~   "
47690|NCT02432833|"~     The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based~     immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months~     following de novo renal transplantation in a real-life setting in different European~     Countries.~   "
47691|NCT02432820|"~     SPECIFIC STUDY AIMS~        1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT~          scans co-registered with transperineal US scans acquired with an optically and/or~          electromagnetically tracked matrix array ultrasound transducer.~        2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array~          transducer imaging and grey-level based image registration algorithms.~   "
47692|NCT02432807|"~     This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride~     ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients~     with moderate to severed Gram-positive bacterial conjunctivitis.~   "
47693|NCT02432794|"~     This is a randomized clinical trial to clarify if the delay phenomenon could reduce the~     incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer~     comparing an experimental group vs control group. The delay phenomenon will be performed by~     an arteriographic approach.~   "
47694|NCT02432781|"~     The primary purpose of this study is to investigate the effects of carbohydrate-rich drink~     on postoperative nausea and vomiting in diabetic patients undergoing total knee~     arthroplasty. The secondary purpose is to investigate the effects of carbohydrate-rich drink~     on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.~   "
47695|NCT02432768|"~     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,~     have insufficient breakdown of sugar stored as, glycogen, within the cells. The~     investigators know from previous studies with McArdle patients, that they not only have a~     reduced sugar metabolism, both also have problems in increasing their fat metabolism during~     exercise to fully compensate for the energy deficiency.~      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that~     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin~     has had a positive effect on the physical performance and has reduces the level of symptoms~     experienced by patients.~      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients~     with McArdle disease on exercise capacity.~      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen,~     Denmark, Hopital Pitié-Sapêtrière in Paris, France and through The University of Texas~     Southwestern Medical Center in Dallas, Texas.~        1. Pre-experimental testing (1 day):~           Baseline blood samples are collected to obtain baseline values of safety parameters:~          Plasma-acylcarnitines, free fatty acids and creatine kinase.~           Subjects perform a max-test to determine their VO2max~        2. Treatment period #1 (2 weeks):~           Subjects follow a diet consuming a dietary treatment oil. Neither patients nor members~          of the study group know who receive which type of oil.~        3. Washout period (1 week):~           Subjects receive no treatment~        4. Treatment period #2 (2 weeks):~      Subjects who received Triheptanoin oil in the first treatment period, now receive placebo~     oil and vice versa.~      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise~     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8~     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale~     questionnaire and metabolic products will be measured in blood and urine.~   "
47696|NCT02432755|"~     The specific aims of this study will be:~        1. To compare the immediate and retention treatment effects of the patients receiving~          home-based mirror therapy combined with task-oriented training (MTOT) with a~          hospital-based MTOT group and a hospital conventional rehabilitation group on different~          aspects of outcomes.~        2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT~          program.~        3. To investigate the factors that may affect the efficacy of home-based stroke~          rehabilitation.~   "
47697|NCT02432742|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane~     compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a~     Chinese population.~   "
47698|NCT02432729|"~     The purpose of this study is to understand the biological and functional changes after one~     year of smoking cessation and to collect data on a broad range of biomarkers of exposure~     (BoExp).~   "
47700|NCT02432703|"~     The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of~     treatment in participants with Social Anxiety Disorder (SAD).~   "
47703|NCT02432664|"~     The purpose of the study is to investigate to what extent this new study drug is tolerated~     in humans.~      The study is divided into 3 parts (Part III is optional and may go ahead depending on the~     results of Parts I and II). The volunteers will only be enrolled to one part of the study.~     In parts I and II the volunteer will receive active study drug or placebo. In part I the~     volunteers will receive a single dose of one of the eight planned escalating dose levels.~      In part II volunteers will receive 4 planned dose levels based on the results obtained in~     Part 1 of the study, with the option to include an additional dosing group.~      In optional part III the volunteer will receive ODM-108 and an already registered drug so~     that interactions with other drugs can be studied.~      It will be investigated how quickly and to what extent the study drug is absorbed and~     eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II~     the effect of the compound on the sensation of pain and on cognition (activities of~     thinking, understanding, learning, and remembering) will be investigated (this is called~     pharmacodynamics).~   "
47704|NCT02432651|"~     The purpose of this research study is to learn if and in what amount a compound from hops,~     called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human~     body is constantly exposed to oxidative stress from environmental compounds (e.g. air~     pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too~     much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world~     has shown that xanthohumol can stop or slow processes that lead to cancer.~   "
47705|NCT02432638|"~     The purpose of this prospective, multi-center, longitudinal study is to assess clinical~     outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO~     (Mandibular distraction osteogenesis). This study aims to develop a scoring system to~     determine success and complication rate pre and post MDO.~   "
47706|NCT02432625|"~     Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People~     with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and,~     in adult years, hearing loss. It is seen in both genders and all races. OI can range from~     very severe to very mild. Individuals with the most severe type of OI may die at birth.~     People with severe OI who survive may have bowed arms and legs, very short stature and be~     unable to walk. People with the mildest form of OI may only break bones occasionally and~     have normal height and lifespan. People with OI also often have problems with the spine. The~     spine problems include compression fractures and scoliosis (a curvature of the spine). DI is~     characterized by grey or brown teeth that may chip and wear down and break easily.~      Before the genetic cause of OI was known, OI was classified into four types. Each type was~     based upon the symptoms and severity of OI. In most people with OI, the cause is a change in~     one of the genes that makes a protein called type 1 collagen. In the past decade, it was~     discovered that in about 5% of people with OI it is in another gene. Some doctors now~     classify OI both on how severe it is as well as which gene is causing OI.~      Our research aims are:~        1. Perform DNA testing and collect natural history data on all individuals enrolled in~          this longitudinal study. The genetic cause of the brittle bone disease will be compared~          with things like severity, various features and response to treatments.~        2. We will see how often people with type I OI have vertebral compression fractures of the~          spine. We will do x-rays to see how often they get compression fractures of the~          vertebrae, what happens over time and any risk factors that increase the risk of these~          compression fractures.~        3. We will follow people with all forms of OI to see how often they develop scoliosis~          (curvature of the spine). We will look at the effects of scoliosis on lung function,~          ability to walk and quality of life. We will also look at the effects of various~          treatments (bracing, surgery, etc.) on scoliosis and lung function.~        4. We will look at dental health in people with OI. We will see how often people with OI~          have problems with teeth alignment. Importantly, we will see how dental health impacts~          a person's quality of life.~   "
47707|NCT02432612|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal~     dose of Sativex in subjects with advanced cancer currently on background Step III opioid~     therapy.~   "
47708|NCT02432599|"~     The rationale for the proposed pilot study is to investigate the ability of PET-CT with~     F18-choline to detect and locate the parathyroid adenoma in patients with primary~     hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical~     ultrasound, in order to avoid unnecessary bilateral cervical exploration.~   "
47709|NCT02432586|"~     18 preschool aged children and their families will attend structured, multidisciplinary,~     family-centered intensive education sessions over a 3-day weekend in a residential camp~     setting to address the unique challenges of managing type 1 diabetes mellitus in young~     children. A second 'booster' session, will be conducted 6 months later.~   "
47710|NCT02432573|"~     In postpartum hospitalized women, does delayed morning rounding improve patient~     satisfaction?~   "
47711|NCT02432560|"~     The MIDAS study aims to follow women with LAM who are currently taking, have previously~     failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or~     everolimus as part of their clinical care.~   "
47712|NCT02432547|"~     This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of~     laser therapy to areas of peripheral retinal ischaemia combined with intravitreal~     aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg~     intravitreal aflibercept according to a treat and extend protocol.~      The specific aim of the study is to test whether laser therapy of peripheral retinal~     ischaemia reduces the overall number of intravitreal aflibercept injections required to~     control DMO over a 24 month period.~   "
47713|NCT02432534|"~     Condition:~      Non segmental and active vitiligo of adulthood.~      Main objective:~      To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB~     compared to UVB alone in active vitiligo after 6 months of treatment.~      Methods:~      Prospective interventional bicentric study with evaluation blinded to the treatment~     received.~      Inclusion criteria:~      Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the~     apparition or the modification of vitiligo lesions with the past 3 months and under Wood's~     lamp examination hypochromic borders and/or spotty depigmentation.~      Interventions:~      After central randomization~        -  Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice~          weekly narrowband UVB treatment for 6 months.~        -  Arm B: with twice weekly narrowband UVB treatment for 6 months.~      Evaluation:~      Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease~     of VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and~     biological tolerance. Variation of CXCL10 levels in the serum.~      Length of the study:~      Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and~     drafting the article: 6 months. Total length: 24 months.~   "
47791|NCT02431520|"~     A study to investigate the compliance of unassisted women to self-collection of specimens~     for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap~     smear collection by medical personnel, as screening method to identify precursor lesions of~     cervical cancer.~   "
47792|NCT02431507|"~     The purpose of this study is to determine the safety and feasibility of the Magnap magnetic~     device in the treatment of obstructive sleep apnea (OSA).~   "
47714|NCT02432521|"~     The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it~     is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke~     sequels are a major public health problem not only in Brazil but in the world, with existing~     treatments often insufficient for complete recovery. Thus this study aims to identify~     predictors of different responses from rehabilitation therapy through the evaluation of~     clinical and neurophysiological data performed before and after treatment. For the~     neurophysiological study will be used the association of electroencephalogram (EEG) and~     transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and~     after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage~     the ability of those technics to analyze the cerebral plasticity. As a secondary objective:~     1) Identify specific features of brain plasticity involved in recovery from stroke and~     discuss the possible implications of these findings in the therapeutic approach; 2) Search~     possible electrophysiological markers that can be used as surrogate outcome of stroke of~     motor sequel.~   "
47715|NCT02432508|"~     Uremic pruritus is a clinically significant symptom which imposes heavy impact on the~     quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to~     investigate the clinical efficacy and mechanism, the investigators designed a multiple~     centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial.~     This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of~     CMUH.~   "
47716|NCT02432495|"~     The management of type II odontoid fractures in geriatric trauma victims remains a source of~     substantial controversy. The purpose of this study was to compare anterior screw fixation~     with halo-vest-immobilization in patients with type II odontoid fractures.~   "
47717|NCT02432482|"~     The purpose of this study is to adapt an existing web-based tobacco treatment program for~     HIV-infected smokers into a mobile intervention delivered via smartphone. After the~     adaptation is completed, the investigators will test the program's efficacy at promoting~     abstinence in a randomized controlled trial.~   "
47718|NCT02432469|"~     The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent~     coronary artery bypass grafting in 1 of 5 participating sites in 2015, and randomized to~     either the intervention group or control group, to test the effectiveness of a smartphone~     based application (APP) focusing on improving patients medication adherence. Patients~     randomized to the intervention group install the APP in their smartphones with personnel~     information and physicians' medication descriptions. The APP reminds at the time of taking~     medications, educates them on secondary prevention for coronary artery disease, and collects~     their weekly situations by questionaires. Investigators will follow-up patients by face to~     face or telephone interview. The 6-month effects of the intervention are evaluated.~   "
47719|NCT02432456|"~     This study will evaluate the effectiveness of ketamine infusions in the management of acute~     pain resulting from broken ribs suffered following a blunt trauma. Half of patients will~     receive the institutional standard of care and a placebo infusion (no active medication).~     The other half of patients will receive the institutional standard of care and a ketamine~     infusion. All subjects and staff will be blinded as to whether they are receiving placebo or~     ketamine.~   "
47720|NCT02432443|"~     Children begin to develop fundamental motor skills (FMS), such as running and kicking, and~     pre-literacy skills, such as rhyming, during early childhood. These skills are very~     important as they lay the foundation for more complex movements and literacy skill~     development later in life, support overall healthy development in several areas, and help~     contribute to the child's readiness for school. A child with strong motor skills is well~     equipped to lead a life with healthy levels of physical activity, positive social~     interactions, positive self-perceptions, and greater cognitive and language abilities. These~     skills will not develop optimally on their own so it is essential to teach, challenge, and~     reinforce them at an early age; often this learning takes place at home prior to entering~     school. Most research on this topic has primarily focused on school-aged children or~     children with specific developmental challenges and less is known about teaching motor and~     pre-literacy skills to young children and giving parents the tools to practice these skills~     at home with their children. The aim of the present study is to examine the effect of a~     motor and pre-literacy program, which emphasizes parental involvement, on motor,~     pre-literacy, social skills, cognitive abilities, and self-competence in 3 to 4 year old~     children with typical development.~   "
47721|NCT02432430|"~     Dissemination research examines the processes and factors that lead to widespread use of~     evidence-based interventions. There are several theories on how to best minimize the~     perceived and actual burdens on practitioners associated with implementing evidence-based~     medicine. For instance, the pay for performance model attempts to improve physician~     compliance with quality guidelines by providing financial incentives. Recent studies suggest~     pay for performance is effective in improving practitioner performance, but it is unclear~     whether the gains are sustainable once incentives are stopped.~      Another approach to promoting best practices is the Model for Improvement whose main method~     is to employ Plan-Do-Study-Act (PDSA) cycles of small changes Although this approach has~     been successful within individual institutions, there is minimal evidence of its effect when~     employed simultaneously in multiple autonomous institutions. There is also little evidence~     of the sustainability of outcomes after intervention activities end.~      The specific aims of the proposed study are to examine the effect of quality improvement~     dissemination models on the immunization coverage of children ages 3 to 18 months old. The~     investigators propose to:~      1. Determine the effect on immunization compliance of two different models of dissemination~     which will provide physicians 12 months of quality improvement (QI) activity support for~     implementing CDC immunization best practices.~      Hypothesis 1a: Study participants receiving the QI technical support intervention (QITS)~     will have more improvement in immunization rates from baseline to immediately after support~     ends than participants receiving the pay for performance intervention (P4P).~      Hypothesis 1b: Study participants receiving QITS will increase immunization coverage for~     their practices over baseline.~      Hypothesis 1c: Study participants receiving P4P will increase immunization coverage for~     their practices over baseline.~   "
47751|NCT02432040|"~     This study aimed to assess the efficacy and safety of atorvastatin 40 mg/day as an adjunct~     to betamethasone valerate 0.1% ointment applied twice daily in the treatment of patients~     with mild to moderate chronic plaque type psoriasis, as determined by mean reduction in PASI~     scores. Specific objectives included the determination and comparison of the absolute number~     and proportion of patients who achieved PASI-50 and the mean reductions in lipid profile~     (total cholesterol, HDL, LDL, triglycerides) and high-sensitivity C-reactive protein (hsCRP)~     measured from baseline and every month thereafter up to 6 months of treatment. This study~     also investigated the impact of atorvastatin treatment on the patients' quality of life as~     well as the association of clinical response to the lipid-lowering and anti-inflammatory~     effects of atorvastatin.~   "
47752|NCT02432027|"~     Evaluate the effects of topical C-82 in a psoriasis plaque test.~   "
47753|NCT02432014|"~     The purpose of this study is to gain a better understanding of family preferences for and~     engagement in services.~   "
47722|NCT02432417|"~     Glioblastomas (GBM) are the most common type of primary brain tumors with an annual~     incidence of approximately 500 patients in the Netherlands. Despite extensive treatment~     including a resection, radiation therapy and chemotherapy, the median overall survival is~     only 14.6 months.~      Epidermal growth factor receptor (EGFR) amplification or mutation is regularly observed in~     GBM and is thought to be a major contributor to resistance to radiotherapy and chemotherapy.~     The most common EGFR mutation in GBM (EGFRvIII) is present in 30-50% of GBM.~      Previously MAASTRO lab has shown that expression of EGFRvIII provides GBM cells with a~     survival advantage when exposed to stress factors such as hypoxia and nutrient deprivation.~     These metabolic stress factors activate a lysosomal degradation pathway, known as autophagy.~     Inhibition of autophagy sensitizes cells to hypoxia, reduces the viable hypoxic fraction in~     tumors with > 40% and subsequently sensitizes these tumors to irradiation.~      Chloroquine (CQ) is a potent autophagy blocker and is the most widely investigated substance~     in this context. Previously, the effect of CQ has been demonstrated in a small randomized~     controlled trial in GBM treated with radiotherapy and carmustine. Although not statistically~     significantly different, the rate of death over time was approximately half as large in~     patients receiving CQ as in patients receiving placebo. The intracellular effects of CQ are~     dose-dependent. Therefore, the authors suggest an increase in daily dose of CQ may be~     necessary. Furthermore, the combination of CQ with TMZ may induce more damage to the~     neoplastic cells.~      In the phase I part of this trial the recommended dose of CQ in combination with~     radiotherapy and temozolomide will be tested. In the phase II part of the trial patients~     with a histologically confirmed GBM will be randomized between standard treatment consisting~     of concurrent radiotherapy with temozolomide and adjuvant temozolomide (arm A) and standard~     treatment plus CQ (arm B).~   "
47723|NCT02432404|"~     To assess potential benefits associated with both intermittent (use for 3 weeks, remove for~     1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR~     use among women either with BV or at high risk for BV. The investigators will also recruit~     women who are HSV2-infected.~   "
47724|NCT02432391|"~     The purpose of this study is to determine if a lifestyle modification program (GEM) that~     focuses on reducing after-meal blood glucose elevations can improve blood glucose control in~     people with type 2 diabetes. Half of the participants will continue their routine medical~     care, and half will receive five sessions of GEM in addition to their routine care. The two~     groups will be assessed using diabetes-relevant medical, behavioral and psychological~     measures.~   "
47725|NCT02432378|"~     The main goal of this research study is to determine if intraperitoneal (IP) administration~     of cisplatin in addition to an investigational vaccine (the DC vaccine) with or without an~     investigational drug combination of IP rintatolimod, IP interferon alpha-2b (IFN), and oral~     celecoxib, has any effect, good or bad, on recurrent ovarian cancer.~   "
47726|NCT02432365|"~     The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2)~     combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the~     following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2~     cervical squamous cell carcinoma (SCC).~   "
47727|NCT02432352|"~     The purpose of this study is to assess the feasibility and acceptability of a family-based~     preventive intervention designed to reduce sexual risk behaviors and depressive symptoms~     among South African adolescents and their parents/guardians/caregivers.~   "
47728|NCT02432339|"~     The purpose of this study is to determine if stopping the stress induced increase in~     inflammation will prevent sodium retention which in turn increases blood pressure. Each~     subject will test two separate times. One week, they will be taking a daily dose of~     mycophenolate mofetil (MMF), the other week they will be taking a placebo.~   "
47729|NCT02432326|"~     This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally~     in combination to patients with advanced solid tumors. The primary goal is to determine the~     safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.~   "
47730|NCT02432313|"~     Parts 1 and 2:~      Subjects take 1 dose of various formulations of the study product, and provide samples for~     pharmacokinetic (PK) analysis after each, with at least 7 days between doses.~      Part 3:~      Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and~     provides samples for PK analysis.~   "
47731|NCT02432300|"~     The purpose of this study is to examine a web-based training program for treating emotional~     problems in people who have suffered a traumatic brain injury (TBI).~   "
47732|NCT02432287|"~     Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known~     beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies~     suggest that in addition to its effects on glucose metabolism, metformin may influence~     metabolic and cellular processes associated with the development of age-related conditions,~     such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis.~     As such, metformin is of particular interest in clinical translational research in aging~     since it may influence fundamental aging factors that underlie multiple age-related~     conditions. The investigators therefore propose a pilot study to examine the effect of~     metformin treatment on the biology of aging in humans. Namely, whether treatment with~     metformin will restore the gene expression profile of older adults with impaired glucose~     tolerance (IGT) to that of young healthy subjects.~   "
47733|NCT02432274|"~     This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib in~     children and adolescents with refractory or relapsed solid malignancies and young adults~     with Osteosarcoma.~   "
47734|NCT02432261|"~     This is a prospective, randomized, double-blinded, two-center trial to evaluate the~     gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T~     gel alone, for 28 days.~   "
47735|NCT02432248|"~     The purpose of this study is to investigate the effect of DHEA for treatment of subfertile~     patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.~   "
47736|NCT02432235|"~     This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin~     lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive~     escalating doses of ADCT-301 every 3 weeks.~      In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks.~   "
47761|NCT02431910|"~     The purpose of this study is analyze the immediate and late effects of the application of KT~     in neuromuscular performance of the quadriceps in postural balance and function of the lower~     limb of healthy subjects.~   "
47833|NCT02430974|"~     Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with~     non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine~     kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the~     efficacy and safety of chemotherapy with or without icotinib in patients undergoing~     resection of stage IB to IIIA EGFR-mutated NSCLC.~   "
47737|NCT02432222|"~     The study will use a randomized controlled trial to test the efficacy of two interventions~     (visual arts and music) for individuals with dementia, focusing on dementia of the~     Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers~     and/or retirement residences. Participants will be tested before and after the intervention~     on a battery of cognitive, affective, and behavioural measures. They will be compared to a~     waitlist control group who don't receive the intervention.~      The purpose of our research is twofold: treatment of symptoms and improved quality of life~     during disease progression in dementia. For the primary aim, the investigators are examining~     the potential of arts interventions on declining functions in dementia (memory, mood, and~     behavior) to investigate potential treatment effects. Secondly, quality of life will be~     measured, with the aim of looking beyond disease progression to contribute to an overall~     positive patient experience. Research has indicated the need for non-pharmacological~     treatments to be used as a first line of action against dementia symptoms and development.~     While, in best practice, pharmacological treatments should be used as a second-line~     approach.~      Note: Music intervention dropped prior to study initiation.~   "
47738|NCT02432209|"~     A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification~     program with tracked increased physical activity and weight loss (intensive) compared to~     recommendations to tracking of increased physical activity alone with weight maintenance~     (standard) in women with obesity and unexplained infertility. This 16 week period of~     lifestyle modification will be followed by an open label empiric infertility treatment~     regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene~     citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and~     intrauterine insemination (IUI).~      Treatment~   "
47739|NCT02432196|"~     This is a Prospective, Single Arm, Single Group Assignment, EU study to demonstrate the~     feasibility and safety of the Harpoon Medical TSD-5 in subjects with degenerative MR~   "
47740|NCT02432183|"~     In this study the investigators will study the lung function and airway inflammation in~     elite athletes starting at the elite sport school (age: 12-13 year) and the change in lung~     function parameters and airway inflammation after 1 and 2 years at the elite sport school in~     comparison to age-matched controls (exercising at a recreational level, <4 hours/week).~   "
47741|NCT02432170|"~     This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as~     an imaging technique to assess arthritis in the foot and ankle.~   "
47742|NCT02432157|"~     Subarachnoid hemorrhage (SAH) occurs after rupture of cerebral aneurysms. Treatment of SAH~     focuses on avoiding medical complications including cerebral vasospasm, which may result in~     limited circulation to the brain. Cerebral vasospasm, or thinning of the arteries of the~     brain, is a feared complication that could potentially cause stroke and worst outcomes after~     SAH. Hypertonic saline (HTS) is a compound that may be used to prevent vasospasm following~     SAH by enhancing the circulation in the brain. This study will evaluate if a protocol of~     volume expansion with HTS is safe and effective in patients with subarachnoid hemorrhage for~     the prevention of cerebral vasospasm.~   "
47743|NCT02432144|"~     UX003-CL202 is an open-label, multi-center extension study to assess long-term safety and~     efficacy of UX003 treatment in patients with MPS 7.~   "
47744|NCT02432131|"~     The investigators will prospectively estimate incidences of decompression sickness in SCUBA~     divers with or without patent foramen ovale (PFO). All participants will receive~     transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO.~     Clinical follow up will be undertaken 3 month after transesophageal echocardiographic~     evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with~     self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will~     be reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a~     neurologist.~   "
47745|NCT02432118|"~     This pilot clinical trial studies the use of the radiofrequency-guided localization in~     patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing~     surgery). The radiofrequency identification localization system consists of an implantable~     radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal~     breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided~     localization may make it easier to find and remove abnormal breast tissue during lumpectomy.~   "
47746|NCT02432105|"~     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to~     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).~   "
47747|NCT02432092|"~     The goal of this protocol is to obtain information from individuals with cardiomyopathy and~     from their families in order to elucidate the molecular genetics of this disorder. This will~     provide the basis for future genetic counseling as well as contribute to elucidating the~     biology of normal and abnormal cardiac function.~   "
47748|NCT02432079|"~     The goal of this study is to obtain specimens and data from individuals and their families~     with heterotaxy and related congenital heart defects in order to clarify the molecular~     genetics of this disorder. The knowledge gained from the analysis of this information will~     provide the basis for future genetic counseling as well as contribute to knowledge about the~     biology of normal and abnormal development of left-right anatomic asymmetry.~   "
47749|NCT02432066|"~     Attempts to quit cigarette smoking are often accompanied by negative mood and problems in~     attention and memory. These effects, in turn, may contribute to smoking relapse. This~     exploratory/developmental project examines the effects of a novel medication, GTS-21, on~     individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce~     negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and~     women who are chronic cigarette smokers.~   "
47750|NCT02432053|"~     The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in~     adult population undergoing kidney or liver transplantation in India.~   "
47777|NCT02431702|"~     The purpose of the study is to compare effectiveness of paliperidone palmitate (PP:~     paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP)~     on delaying time to treatment failure. The study will also evaluate changes in cognition,~     functioning, brain intracortical myelin (ICM) volume following treatment with PP compared~     with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.~   "
47754|NCT02432001|"~     The purpose of this study is to better understand how cancer treatment may affect cancer~     cells. The research will involve genetic, molecular, cellular, and immunologic experiments~     using blood and tumor specimens. It is hoped that the information gained from these studies~     will lead to a greater understanding of castrate-resistant prostate cancer and potentially,~     improvements in cancer treatment.~      This is a tissue collection protocol requiring image-guided biopsies of metastatic,~     castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling~     patients with metastatic CRPC who have progressed while receiving novel AR-targeted~     therapeutics such as abiraterone and enzalutamide. This population of patients was selected~     because resistance develops relatively rapidly following potent inhibitors of AR activity~     and the mechanisms of resistance have to be better understood. Without comprehensive~     analysis of mCRPC tumor, the investigators will never gain a full understanding of the~     biology driving resistance in human disease and developing rational co-targeting approaches~     will not be possible.~   "
47755|NCT02431988|"~     The purpose of this study is to administer novel cluster of differentiation antigen 19~     (CD19) specific Chimeric Antigen Receptor T-cells (CAR19 T-cells) to patients with relapsed~     or resistant Diffuse Large B Cell Lymphoma (DLBCL) to assess the safety and efficacy of this~     strategy as a bridge to allogeneic transplantation.~   "
47756|NCT02431975|"~     The investigators propose a non-randomized clinical trial of 60 HIV-infected infants~     identified within 48 hours of birth and their mothers to investigate the consequences of~     very early ART on the establishment and maintenance of the viral reservoir.~      The first phase (early ART initiation within 48 hours of birth) will examine the trajectory~     i.e. changes over time of the viral reservoir and detection of HIV-specific antibody~     responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.~      Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are~     associated with the extent of seeding and rate of decline of the viral reservoir when ART is~     started at a young age and investigate whether markers in infant stool samples can be used~     as a non-invasive method of defining relevant immune and HIV-specific parameters associated~     with viral reservoir size.~      The investigators hypothesize that developmental characteristics of newborn immunity may~     make this period the optimal time to begin ART and influence the seeding of the viral~     reservoir.~   "
47757|NCT02431962|"~     Lung cancer is the leading cause of cancer death in North America and in the world. The vast~     majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority~     of lung cancers are detected at an advanced stage when they have a very poor prognosis. A~     substantial amount of data has been reported on low-dose computed tomography (LDCT)~     screening. Yet endorsement of lung cancer screening has not been universal because of~     outstanding concerns which need to be addressed. Our study will aim to screen at risk~     Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to~     fill some knowledge gaps on this topic.~   "
47758|NCT02431949|"~     The perception of music requires coordinated neural activities in distributed~     multi-functional centers across both hemispheres. The association between musical abilities~     and other general cognitive functions have been studied in several populations with~     inconsistent results.~      Schizophrenia is a major mental disorder that is strongly associated with cognitive~     deficits. These often appear before the onset of psychotic symptoms and persist throughout~     effective treatment of positive and negative symptoms. Like other disorders of psychosis,~     schizophrenia features general deficits in auditory memory and sensory processing. Recently,~     Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese~     schizophrenic populations. They both used a standardized assessment for amusia called~     Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception~     of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in~     music perception were associated with cognitive deficits and negative symptoms. In regards~     to positive symptoms, Wen et al., but not Sawada et al., found a significant association.~      The present clinical study will assess musical abilities using the MBEA in a Canadian~     population with and without refractory psychosis. It will explore associations between~     musical deficits, positive and negative psychiatric symptomology and cognition. The patient~     population will have a diagnosis of schizophrenia, schizoaffective disorder, affective~     disorder with psychosis or non substance-related psychosis who were referred to the British~     Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of~     antipsychotics. A focus on refractory psychosis may provide greater insights because these~     patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It~     will also be valuable to administer the MBEA assessment on a Canadian population, because~     the test was originally intended for Western populations and its musical phrases were~     designed with Western tonalities.~   "
47759|NCT02431936|"~     High blood pressure, or hypertension, is a serious problem in the African-American (AA)~     population which affects nearly 7 of every 10 AAs in our area. Previously the investigators~     showed that a significant number of AAs held onto or retained salt during mental stress~     (sodium retainers). The investigators believe that the increased salt load and resulting~     blood pressure load contributes to the eventual development of hypertension in these~     individuals. The purpose of this study is to find out if this response is due to the direct~     stimulation of the kidney (the organ that controls salt levels in the body, by the brain).~     To do this, the investigators will determine if a drug that stops the connection between the~     brain and the kidney during mental stress will prevent sodium retention in sodium retainers.~     Prazosin is an alpha adrenergic receptor blocker that has been approved by the Food and Drug~     Administration (FDA). None of the subjects who participate in this study have high blood~     pressure. The subjects will not know which testing week is the drug week and which is the~     placebo week.~   "
47760|NCT02431923|"~     Background:~      - Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects.~     Researchers want to learn what ill health conditions Ebola survivors have. They want to~     learn if Ebola survivors can infect others in their household through close contact. They~     also want to learn if Ebola survivors are immune from getting Ebola again. To learn these~     things, they want to follow people in Liberia for 5 years.~      Objectives:~      - To learn how Ebola affects the health of survivors and the people they live with.~      Eligibility:~      - People in Liberia who had Ebola in the past 2 years, who share a household with someone~     who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because~     they did not have Ebola.~      Design:~        -  Participants will be screened with family illness history, physical exam, and blood~          tests. They may have an eye exam.~        -  Ebola survivors and those who went to a Treatment Unit but did not have Ebola will~          visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit,~          they will repeat the screening tests.~        -  Participants who live with someone who had Ebola will have only the screening visit.~          But they may be asked to return for follow-up visits. These visits will help~          researchers learn more about the differences between those who have had Ebola and those~          who have not.~        -  Participants brought to the NIH Clinical Center will have documentation of positive~          Ebola virus PCR and a clinical syndrome compatible with acute EVD.~        -  The study will last 5 years.~   "
47762|NCT02431897|"~     This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning~     native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued~     postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and~     basic science investigation are designed to understand the mechanisms by which local~     estrogen treatment affects connective tissues of the pelvic floor and determine whether its~     use before and after prolapse repair will (i) improve success rates of the surgical~     intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of~     other pelvic floor disorders.~   "
47763|NCT02431884|"~     The purpose of this study is to collect a portion of blood/tissue specimens that will be~     generated during the participants office visit or surgery. The investigators are asking~     whether a small portion of the specimen/s could be set aside and banked for future research~     purposes. Data originating from participants will be gathered and analyzed in research~     studies that will help understanding various medical conditions such as polycystic ovary~     syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis,~     and infertility.~   "
47764|NCT02431871|"~     The aim of this study is to assess long term effects of developmental dysplasia of the hip~     (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip~     symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of~     170 children and young adults treated for DDH in their childhood with age and sex matched~     controls.~   "
47765|NCT02431858|"~     To randomize 108 patients undergoing knee replacement surgery to catheter through needle or~     catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if~     there is a difference.~   "
47766|NCT02431845|"~     The purpose of this study is to determine whether pharmacogenetic study predict selective~     serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the~     drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.~   "
47767|NCT02431832|"~     An open-label, one-sequence, multiple administration study for exploration of microRNA and~     metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean~     people.~   "
47768|NCT02431819|"~     Elastic compression stockings are recommended in the treatment venous insufficiency.~     Degressive compressive stockings have been used for many decades and are characterized by a~     high pressure applied at the ankle and a decreasing pressure from the ankle to the knee.~     Progressive compressive stockings were developed to have a maximal pressure at the calf.~     This concept is based on the calf pump role in the venous return. Patients with PAD~     (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic~     compression stockings are strictly contraindicated for patients with PAD because highest~     pressures on ankle could slow down the superficial microcirculation.~      On patients with PAD and venous insufficiency, the progressive compressive stockings could~     be well indicated. Strongest pressure at the calf should increase the pump effect and the~     muscle mechanical efficiency during the walk without deleterious effect.~   "
47769|NCT02431806|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major~     Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics~     (PK) data to guide dose selection for future pediatric studies of levomilnacipran.~   "
47770|NCT02431793|"~     The purpose of this study is to test the effectiveness of an electronic health record based~     strategy in promoting safe use of opioid medications after an Emergency Department visit.~     The EHR-based strategy was designed to enhance provider counseling about opioids and to~     standardize and simplify the information that patients receive.~   "
47771|NCT02431780|"~     The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical~     investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition,~     the ANSER Software system.~   "
47772|NCT02431767|"~     The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and~     interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM)~     injection with electroporation (EP), in healthy, HIV-uninfected adults.~   "
47773|NCT02431754|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     known as tadalafil in participants with benign prostatic hyperplasia who are being treated~     with an alpha1 blocker. This study has two treatment periods. Participants will receive~     tadalafil or placebo in each treatment period.~   "
47774|NCT02431741|"~     This is a prospective, open, non-controlled clinical investigation to evaluate the~     performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten~     to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant~     (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant~     (fungating) wound selected as a study site. Subjects will be followed for a one-week~     observation period with their existing product followed by a 4-week investigation period~     using Mepilex Transfer Ag.~   "
47775|NCT02431728|"~     Individuals recovering from drug and/or alcohol addiction initially experience the symptoms~     of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS~     include a wide array of emotional and psychological symptoms such as anxiety, sleep~     disturbances, depression, and stress. Previous studies have shown that melatonin therapy was~     beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no~     randomized, double-blind, placebo controlled trials have been conducted in males who are~     experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin~     given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms,~     insomnia, and stress in males with PAWS who reside in a residential treatment center.~   "
47776|NCT02431715|"~     Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the~     gastroenteropancreatic tract. They are usually slow growing, have low malignant potential,~     and often go unnoticed until they become metastatic. The correct treatment approach is~     dependent on the extent of the disease, however surgical approaches and systemic therapy can~     be curative.~      Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer~     18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising~     non-invasive technique to help localizing NETs and guide their treatment.~   "
47779|NCT02431676|"~     This is a prospective, single-center randomized trial with three arms, and an allocation~     ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin~     and coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and~     IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The~     coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication~     system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical~     intervention of oral metformin. This is a secondary prevention study for men and women who~     have survived solid malignant tumors~   "
47780|NCT02431663|"~     To evaluate the efficacy of intravenous administration of ketamine in the treatment of~     refractory convulsive status epilepticus in children compared to administration of midazolam~     at high doses, thiopental and / or propofol.~   "
47781|NCT02431650|"~     This is a single-centre, controlled, open label study using P. falciparum-induced blood~     stage malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal~     agent, as well as its treatment effects on gametocyte infectivity and development in vector~     mosquitoes. Previous clinical studies including one IBSM study have shown that in addition~     to effectively clearing replicating, asexual (pathogenic) life cycle stages of malaria, a~     single dose of piperaquine (480 mg) results in the production of gametocytes, as determined~     by gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce~     gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a~     gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both~     direct feeding on participants and artificial (indirect) membrane mosquito feeding will be~     performed. The study will be conducted in up to 3 cohorts where participants will be~     randomised into an experimental or a control group (n=2 per group) when peak gametocytemia~     occurs (approximately 15 days after administration of piperaquine).~   "
47782|NCT02431637|"~     This is a single-centre, open-label study using P. falciparum-induced blood stage malaria~     (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria~     parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that~     treatment of participants with the antimalarial drug piperaquine, in addition to effectively~     clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of~     gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be~     employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this~     purpose, experimental mosquito feeding directly on participants and artificial membrane~     mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per~     cohort). Subsequent cohorts will not commence until at least after day 28 of the previous~     cohort and review by Safety Review Team. This interval will also allow cohorting of~     experimental infection of mosquitoes to optimise logistics and enable iterative improvements~     in the system if applicable.~   "
47783|NCT02431624|"~     The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.~   "
47784|NCT02431611|"~     Phase 3 Pilot Clinical Trial.~   "
47785|NCT02431598|"~     The purpose of this study is to evaluate changes in volunteer breath-holding capacity in~     response to gadoxetate disodium (Eovist) administration, compared with saline, and~     gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study~     sites. These subjects will be given three, blinded, randomized injections while undergoing~     an MRI of their liver and holding their breath. During the scan, the subjects' oxygen~     saturation and heart rate will be closely monitored. Following the scan, the subjects will~     complete a questionnaire regarding the breath hold.~   "
47786|NCT02431585|"~     Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in~     which neither allergic nor autoimmune mechanisms can be identified, has been added to the~     spectrum of gluten-related disorders. This condition is characterized by gastrointestinal~     and extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache~     (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually~     normal. The prevalence of GS is not yet established although it is estimated that up to 6%~     of the general population might be affected. GS has been described only in adults and no~     data are available for the paediatric population.The main problem with this new condition is~     that, at present, there are no speciﬁc biomarkers to conﬁrm GS diagnosis. In the absence of~     a serological or histological marker, the diagnosis remains clinical. In order to avoid~     placebo effect of the dietary treatment, presently GS diagnosis needs to performed with~     double-blind randomized placebo-controlled challenge provided that both wheat allergy and CD~     have previously been excluded.~      The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients.~      The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile~     of GS patient and 2) to study the role of gluten or other possible wheat components in the~     onset of GS.~      Study design Randomized double blind placebo controlled cross over re-challenge trial.~     Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of~     coeliac disease and wheat allergy has been excluded, will be considered eligible for the~     study.~      Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA~     and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively.~      Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2),~     diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III:~     week 5-12)~   "
47787|NCT02431572|"~     This research study is studying the changes in primary and metastatic brain tumor~     inflammation using positron emission tomography (PET) imaging using a radioactive substance~     called [11C] PBR28a, which is also known as peripheral benzodiazepine receptors (PBR), or~     PBR-PET.~   "
47788|NCT02431559|"~     This is an open-label, non‐randomized, multicenter Phase 1/2 study of MEDI4736 in subjects~     with recurrent, platinum-resistant ovarian cancer, scheduled to receive Pegylated Liposomal~     Doxorubicin (PLD). Subjects will be treated during each 28-day cycle according to the~     treatment schedule.~   "
47789|NCT02431546|"~     The purpose of this study is to understand the effects of a mobile health cardiovascular~     prevention program in patients who have recently graduated from cardiac rehabilitation. The~     mobile health program will focus on promoting healthy lifestyles through the use of a mobile~     application (app), mobile physical activity monitor and a system of remote health coaching.~      By testing a novel mHealth intervention focused on lifestyle modification, this trial will~     address a critical evidence gap in the care of patients after they graduate from CR. Many~     patients who graduate from traditional CR struggle with unhealthy lifestyles, and these~     patients currently have no lifestyle-based care strategies to help them. The results of this~     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based~     preventive care strategies for patients with stable CVD.~   "
47790|NCT02431533|"~     IBS is a disorder of movement in the gut. People who have IBS may have diarrhea,~     constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often~     the only way doctors can diagnose it is to rule out other conditions through testing.~   "
47793|NCT02431494|"~     Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in~     visible lesions that can be quite disfiguring. Consequently, individuals with acne often~     suffer from a wide range of psychological manifestations. Although there is consensus that~     combination therapy is most effective in treating acne, researchers are constantly striving~     to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has~     successfully been used to promote wound healing and has been routinely used in aesthetics.~     Use of MCT alone or in combination with current successful treatment such as blue light~     phototherapy (BLP), may hold promise for acne treatment. The investigators propose to~     conduct a small randomized control trial to determine the safety and preliminary efficacy of~     a novel combination therapy to treat acne vulgaris. The investigators will recruit up to 60~     males and females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination~     therapy (BLP and MCT). The investigators will assess physiological parameters (number of~     acne lesions, amount of sebum produced, degree of acne severity) and psychosocial factors~     (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem).~     Participants will complete a baseline assessment prior to initiating treatment and a~     follow-up assessment at 4 weeks post termination of treatment. The investigators will~     conduct intermediary assessments at weeks 3 and 5 and 1 week post termination of the~     treatment. The investigators will use measures of central tendency to describe the sample~     and repeated measures analysis of variance to compute the main and interaction effects.~   "
47794|NCT02431481|"~     The purpose of this study is to characterize the PK and safety profile of LEE011 following a~     single oral dose in adult subjects with various degrees of renal impairment compared to a~     matched group of healthy subjects with normal renal function.~   "
47795|NCT02431468|"~     This is a randomized double-blind placebo-controlled study comparing different doses of~     bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study~     is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last~     dose of study drug.~   "
47796|NCT02431455|"~     This study evaluates the omission of incentive spirometry use following bariatric surgery.~     Half of participants will receive an incentive spirometer while the other half will not.~     Oxygen saturation and pulmonary complications after surgery will be measured to examine the~     effectiveness of incentive spirometry.~   "
47797|NCT02431442|"~     The purpose of this study is to evaluate the multiple dose safety and tolerability of RM-493~     (setmelanotide) as well as pharmacokinetic (PK) and pharmacodynamic (PD; weight loss)~     profile, in healthy obese patients for 2 to 4 weeks. In addition, one panel of patients with~     a specific genetic deficiency in the hypothalamic leptin- proopiomelanocortin (POMC) -~     melanocortin-4 receptor (MC4R) pathway, those with heterozygous partial or full loss of~     function (LOF) of the MC4R gene, will also be studied. The study drug (RM-493 and placebo)~     will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or~     injection.~   "
47798|NCT02431429|"~     This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult~     male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide~     semen samples for spermiogram analysis of sperm parameters.~   "
47799|NCT02431416|"~     The purposes of the study is to investigate whether circulating levels of ghrelin decreases~     after an iv injection of GnRH in girls with suspected central premature puberty and to~     investigate the effects of different post sampling handling on the preservation of acylated~     ghrelin.~   "
47800|NCT02431403|"~     Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage~     therapy in relapsed/refractory non-Hodgkin's lymphoma~   "
47801|NCT02431390|"~     This study is to investigate whether the RAPAELⓇ Smart Glove digital treatment system~     improves the upper extremity function of stroke patients compared to other clinical~     treatment by measuring serial behavioral and neuroimaging assessments and to find out~     therapeutic effect or adverse effect and patient's feed back responses~   "
47802|NCT02431377|"~     A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of~     the study formula (SF), containing a whey protein concentrate enriched with~     alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.~   "
47803|NCT02431364|"~     This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate~     the safety and tolerability of verdinexor. Verdinexor or placebo will be given on days 1 and~     3 to healthy adult subjects.~   "
47804|NCT02431351|"~     This is an open-label study designed to evaluate the safety and efficacy of the selective~     inhibitor of nuclear export (SINE) compound, Selinexor given orally to patients with~     transfusion-dependent, EPO-refractory lower-risk MDS (Low risk and Intermediate-1 as defined~     by IPSS).~   "
47805|NCT02431338|"~     The aim of this study is to investigate the cost-effectiveness of remote ischemic~     conditioning as an adjunct to primary percutaneous coronary intervention from the~     perspective of a Danish healthcare system.~   "
47806|NCT02431325|"~     The purpose of this research study is to determine whether teduglutide can repair a leaky~     gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other~     materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to~     inflammatory changes and leakiness of the gut. These changes or conditions may increase the~     risk of developing heart and blood vessel disease. The investigators believe teduglutide can~     help repair the gut barrier in people with HIV, leading to a decrease in inflammation and~     plaque in the blood vessels of the heart.~   "
47807|NCT02431312|"~     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of dose~     combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid~     encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety)~     nucleos(t)ide analogue treated patients.~   "
47832|NCT02430987|"~     OBJECTIVE: To evaluate the prevalence of metabolic syndrome in postmenopausal women with a~     diagnosis of Hypoactive Sexual Desire Disorder. CASUISTIC AND METHODS: This is a~     case-control study in postmenopausal women attend in Menopause Clinic of the Faculty of~     Medical Sciences of Santa Casa de São Paulo. The investigators will select women diagnosed~     with HSDD. All women will sign the Consentment term. Those selected will assess the~     prevalence of MS through the ATPIII criteria. Sexual function are assessed by questionnaire~     Female Sexual Function Index (FSFI). RESULTS: The investigators hope there is greater~     prevalence of MS in women after menopause with HSDD.~   "
47808|NCT02431299|"~     Illness Management and Recovery (IMR) is an evidenced-based approach to teaching consumers~     with severe mental illness how to set and achieve personal recovery goals and acquire the~     knowledge and skills to independently manage their illnesses. Longitudinal, multi-site, and~     randomized controlled trials have shown IMR to be effective in increasing illness~     self-management and coping; some evidence also points to reduced hospitalization rates.~     Fidelity, or adherence to a specific treatment model, is equally important to both clinical~     research and to the practical dissemination of evidence-based practices to the field.~      To this end, the research team has developed an IMR clinician-level fidelity assessment, the~     IMR Treatment Integrity Scale (IT-IS). However, the validity of the preliminary IT-IS has~     not been rigorously evaluated. Additionally, it is crucial to develop strategies to utilize~     the IT IS to increase adherence to the IMR model and ultimately increase consumer outcomes.~      The purpose of this study is to assess the construct validity of the IT-IS by testing the~     relationship between IT-IS elements and mechanisms of change and proximal outcomes. The~     investigators will collect a sample of IMR session recordings and pre-post data from IMR~     participants from recruitment sites in Indiana, New Jersey and several other states. The~     investigators will test hypothesized relationships between specific program elements and~     theoretically proposed mechanisms of change. The investigators will also assess~     organizational and clinician factors affecting IMR competence by including a survey for the~     staff members who are located as sites where the investigators have clinicians participating~     in providing IMR.~   "
47809|NCT02431286|"~     The objective of this study is to investigate if aprepitant in association with palonosetron~     and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom,~     undergoing cancer surgery mastectomies.~   "
47810|NCT02431273|"~     This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a~     sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate~     (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following~     drug combinations: 1) TDF (Single IVR); 2) TDF-FTC (Dual IVR) and; 3) TDF-FTC-MVC~     (Triple IVR).~   "
47811|NCT02431260|"~     This is a study of INCB054329 given to patients with advanced malignancies that will be~     conducted in three treatment groups. Each treatment group will have two parts; a dose~     escalation (Part 1) and an expansion (Part 2).~   "
47812|NCT02431247|"~     The purpose of this study is to demonstrate non-inferiority in efficacy of a~     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination~     (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with~     Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1~     (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.~   "
47813|NCT02431234|"~     The blood concentration of the protein RANKL could be predictive of the calcification of the~     leg arteries, which is a major complication occurring during diabetes. The objective of the~     DIACART study is to show that blood RANKL concentration predict the progression of~     calcification of the leg arteries in diabetic patients, independently of other~     cardiovascular risk factors.~   "
47814|NCT02431221|"~     A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with~     Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure~   "
47815|NCT02431208|"~     This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and~     pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various~     immunomodulatory agents in participants with MM who have relapsed or who have undergone~     autologous stem cell transplantation (ASCT). The planned duration of this study is~     approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in~     Cohorts D to F.~   "
47816|NCT02431195|"~     The main objective of this study is to identify changes in eating behaviors and physical~     activity in patients after bariatric surgery and their family members living in same~     household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a~     civil union.~   "
47817|NCT02431182|"~     Randomized controlled trial to assess the effectiveness of a Memory Training Workshop in~     cognitive function, in terms of self-perceived memory, everyday memory and executive control~     abilities. It is expected that the group intervention of memory training that this study~     proposes significantly improves cognition (memory, attention and executive control~     abilities) and the quality of life related to health (HRQOL) in the Experimental Group (EG)~     compared to the Control Group (CG). The group of individuals that take part in the Memory~     Training Workshops (Experimental Group) will be compared to another group of similar~     characteristics that do not (Control Group). Data will be collected at baseline, 3 months~     later and 6 months later.~   "
47818|NCT02431169|"~     The investigators propose to conduct a pilot feasibility study of single agent erlotinib in~     patients with metastatic EGFR mutant adenocarcinoma of the lung with up to one prior~     treatment with the sole purpose of characterizing the genomic landscape before erlotinib and~     at the time of disease progression. The logistics of obtaining adequate quality fresh tissue~     specimens for sequencing studies before therapy and at the time of disease progression in~     patients with advanced lung cancer are complex and a thorough understanding of the practical~     challenges in conducting a study like this is crucial.~      The current proposal will include exome and transcriptome sequencing from blood collected at~     baseline along with tumor samples obtained prior to starting erlotinib and at the time of~     disease progression (a total of two tissue samples and one blood sample per patient). If~     carried out successfully, the proposed strategy very likely will lead to a larger and~     adequately powered study to understand fully evolving molecular changes due to clonal~     selection under treatment pressure. The pace of progress in the field of sequencing~     technology currently underway is only likely to accelerate in the near future yielding~     richer and highly content-rich information. Moreover, it is likely that genomic information~     from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and~     proteomes.~      The investigators plan to sequence paired tumor specimens from 20 patients with EGFR mutant~     adenocarcinoma of the lung before treatment with erlotinib and at the time of disease~     progression following treatment with erlotinib. As the investigators expect some drop off~     (due to unexpected clinical events precluding a second biopsy at the time of disease~     progression, poor specimen quality and early discontinuation of therapy for~     non-progression), the investigators will enroll 40 patients in this trial to get 20-paired~     specimens.~   "
47819|NCT02431156|"~     Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery for~     presbyopia correction with monofocal intraocular lenses implantation are supposed to have~     sufficient uncorrected vision capacity for activities of daily living (ADLs) that require:~     a) distant vision(DV), (ie. driving), b) intermediate vision (IV), (ie. computer word~     processing), c) near vision (NV), (ie. book reading). Primary objectives of the study are:~     1) the development of a series of tasks in a research setting that will simulate common ADLs~     that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in~     the research setting with demographic, clinical and other parameters of the study~     participants.~   "
47820|NCT02431143|"~     This is a multicenter, non-comparative, open-label clinical trial to assess the~     Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the~     treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy~     and Pharmacodynamics (PD) will be assessed as secondary outcomes.~      The proposed study aims to assess whether drug exposure in children can be increased to~     equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28~     days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present~     study is also expected to provide the basis for minimum time to reach sufficient drug~     exposure for miltefosine activity to guide optimal treatment duration to be used in~     combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial~     using a compartmental population PK approach.~   "
47821|NCT02431130|"~     The goal of this study is to examine whether low‐fidelity instructor‐driven simulation can~     provide effective teaching of anesthetists' non‐technical skills in a developing world~     context. Human factors, such as communication, planning, and team working are considered~     nontechnical skills which contribute greatly to patient safety in complex hazardous~     systems such as aviation, nuclear power industry, and operating rooms. Simulation began in~     the aviation industry to train pilots in human factors. In the past two decades simulation~     has been valued in medical education as it allows the learner to rehearse skills in an~     environment that is similar to the workplace but without the threat of harm to patients.~     High Fidelity simulators involve computer driven interactive mannequins that recreate an~     authentic environment. This has been used successfully to teach anesthetists' non‐technical~     skills (ANTS) such as: decision making, team working, task management, and situation~     awareness. Anesthetists' non‐technical skills are particularly important in developing~     countries where the shortage of supplies, equipment, and qualified personnel can lead to a~     perilous working environment making team work and communication vital for patient safety.~     The costs of high fidelity simulation are prohibitive for many developing countries. This~     study seeks to examine whether low fidelity instructor driven simulation can provide an~     effective intervention to teach anesthetists' non‐technical skills in Rwanda. If found to be~     effective, this method of training could be applied to other developing countries to improve~     non‐technical skills for anesthesia providers with the goal of making surgery safer.~   "
47822|NCT02431117|"~     To evaluate the suitability (i.e. number of tests completed and number of participants~     completing the tests, variance estimate of baseline and of the change from baseline values)~     of neurocognitive tests and functioning scales in view of their use in future multicenter,~     multinational clinical efficacy trials testing a putative cognitive enhancer for individuals~     with Down syndrome aged 6-30.~   "
47823|NCT02431104|"~     A single-center prospective, open-label, uncontrolled study in 10 male or female subjects,~     age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.~   "
47824|NCT02431091|"~     The purpose of this study is to determine the sensitivity and specificity of the use of~     optical coherence tomography to detect HIV-associated neurocognitive disorder compared to~     MRI and usual cognitive screening tools.~   "
47825|NCT02431078|"~     The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer,~     its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in~     invasion and metastasis in gastric cancer.~   "
47826|NCT02431065|"~     Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use~     of ultrasonography is recommended to perform the block at the precise location. Recently,~     intra-operative rectus sheath block has also been introduced without the aid of~     ultrasonography. However, no study has not yet compared the analgesic effects of these two~     different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study~     is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block~     after single-port access laparoscopy in benign ovary cyst patients.~   "
47827|NCT02431052|"~     The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel~     compared to vehicle in patients with acne vulgaris.~   "
47828|NCT02431039|"~     This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine~     diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of~     intraoperative handling.~   "
47829|NCT02431026|"~     The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients~     who were resuscitated following cardiac arrest but who remained comatose. Induced mild~     hypothermia is now the standard of care for post-resuscitation patients in the intensive~     care unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency~     department (ED) application as more current studies show that early initiation of cooling~     significantly improves neurologic outcomes and survival rates instead of waiting until the~     patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline~     (4°C) and packing the body in ice have been the primary methods to initiate induced mild~     hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that~     provides cooling to the carotid arteries, the main blood supply to the brain, and allows for~     the rapid initiation of selective cerebral cooling. The investigators are planning to use~     MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature~     when applied by itself.~      Healthy volunteers will be used for this study to provide important temperature data on the~     effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the~     data from this project to further the current clinical research in induced mild hypothermia~     after cardiac arrest.~   "
47830|NCT02431013|"~     This is a randomized, open-label, single & multiple-dose, parallel study to investigate the~     effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male~     volunteers~   "
47831|NCT02431000|"~     PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility~     preservation by sperm freezing prior to starting treatment requiring alkylating agents~     and/or total body irradiation.~      Secondary objective: To assess pre- and post-treatment sperm production and hormonal status~     by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating~     hormone (FSH), luteinizing hormone (LH), testosterone, and androstendione.~   "
47834|NCT02430961|"~     Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients~     can donate tissue and organs following death after withdrawal of life sustaining therapies~     (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this~     is a significant emotional and resource burden to families, healthcare workers and~     hospitals. A tool that allows accurate prediction of time to death following WLST (and thus~     the probability of successful donation) is urgently needed. Existing models have not been~     useful due to the lack of generalizability. Additionally, existing models have not included~     other important factors now recognized to be associated with time to death following WLST.~      The investigators will conduct a prospective, observational cohort study of all patients~     being considered for DCD in whom consent for donation is obtained to evaluate the~     association between neurologic and non-neurologic risk factors for apnea, other clinically~     important variables and time to death after WLST, and use these data to derive a~     generalizable predictive model for the prediction of the time to death following WLST in~     potential DCD donors.~   "
47835|NCT02430948|"~     The study hypothesis is that clearer visual presentation of guideline recommendations and~     educational outreach, or academic detailing, can improve guideline compliance. However, it~     will investigate other aspects of screening-related decision-making, such as provider and~     patient beliefs about screening, provider-patient communication and patient's willingness to~     forgo expected testing. The research question is whether educational interventions can~     decrease non-compliance with screening guidelines for 5 common cancers.~   "
47836|NCT02430935|"~     The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT)~     for early intervention as compared against an active control in which Action Based Cognitive~     Remediation (ABCR) will be applied.~   "
47837|NCT02430922|"~     The objective of this clinical investigation is to evaluate the short-term (up to 12 months)~     outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic~     (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.~   "
47838|NCT02430909|"~     The purpose of this study is to evaluate the safety, efficacy and body distribution of~     Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid~     Arthritis. Neither the patient nor the doctor will know the treatment group.~   "
47839|NCT02430896|"~     The objective of this study is to identification of neuropsychological, genetic and~     neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity~     disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or~     atomoxetine) for ADHD will be observed for 52 weeks. They will do several~     neuropsychological, neuroimaging and genetic tests at visit 1~6.~   "
47840|NCT02430883|"~     We want to serach the relationship between the pain degree and stone localisation in kidney~     in Retrograde intrarenal surgery~   "
47841|NCT02430870|"~     This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose~     study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This~     study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when~     administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy~     participants of Japanese decent and participants with T2DM.~   "
47842|NCT02430857|"~     This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in~     patients with latent hypothyroidism.~      One half of the participants will receive an osteopathic manuel treatment in order to~     stimulate the relevant segments, the other half will receive no treatment.~   "
47843|NCT02430844|"~     Title: Role of biomarkers in predicting contrast-induced acute kidney injury in critically~     ill patients: a prospective observational study~      Objective: To analyse the role of plasma and urinary biomarkers (Neutrophil~     Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in~     predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.~      Summary of the project:~      Acute deterioration of renal function after intravenous administration of radiocontrast~     media, i.e. increase in serum creatinine concentration of more than 0.5 mg/dl or 25% above~     baseline within 48 hours, is referred to as contrast-induced kidney injury (CI-AKI). The~     increasing number of diagnostic procedures requiring radiographic contrast has parallel~     increase in the incidence of CI-AKI. CI-AKI is described as the third most common cause of~     new AKI in hospitalized patients. Occurrence of CI-AKI is reported up to 55% in high risk~     patients like presence pre-existing chronic renal dysfunction, diabetes, hypertension,~     chronic heart failure, advanced age, volume depletion, uses of concurrent nephrotoxic~     medication. These risk factors for CI-AKI are common in critically ill patients. Recently,~     different urinary and serum proteins have been intensively investigated as possible~     biomarkers for the early diagnosis of AKI, which includes Neutrophil Gelatinase-Associated~     Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1 (KIM 1). At present, there is~     scarcity of prospective study on CI-AKI and role of biomarkers in critically ill medical or~     medical-surgical mixed ICU patients.~      The investigators plan to enroll about 100 ICU patients during 2 years, requiring computed~     tomography (CT) scans with parenteral administration of iodinated radiographic contrast for~     any diagnostic purposes as decided by the clinicians during the treatment of the patients.~     In this prospective observation study, the investigators want to analyse the role of plasma~     and urinary biomarkers in predicting CI-AKI in critically ill patients.~      Key Words: acute kidney injury, radiographic contrast, critically ill, biomarker~   "
47844|NCT02430831|"~     Study type:~      Randomized controlled trial with two parallel arms Objectives~      Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula~     containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary :~     Evaluate the effects of daily supplementation of colicky infants with Nidina formula~     containing L. reuteri DSM 17938 measured as~        1. the number of responders or the treatment success (ie infants for which defined as~          the percentage of children achieving a reduction in the daily average crying time >50%~          in 3 weeks. (day 1 to day 21 of the study)~        2. maternal depression and family functioning scoring~   "
47845|NCT02430818|"~     Opioid pain medications such as morphine and dilaudid are commonly used in emergency~     departments to treat pain in patients. Physicians are familiar with the side effects of~     these medications; the most concerning of which is slowing or stopping a patient's~     breathing, as well as dangerously lowering their blood pressure. An alternative medication~     is ketamine. This medication is also commonly used in the emergency department, although it~     is typically used to help sedate patients for uncomfortable procedures. Ketamine has also~     been used for pain control, but in a much lower dosage that does not sedate patients. When~     used for analgesia, it has typically been administered in combination with opioid pain~     medications. To date, there is no study that looks at the effectiveness and safety of using~     a low dose ketamine alone in comparison to the use of morphine. The purpose of this study is~     to measure how well low-dose ketamine treats pain compared to morphine and to look at how~     often serious side effects are seen with each medication.~   "
47846|NCT02430805|"~     This project aims at investigating the genetic, genomic and proteomic basis of hypertension~     and susceptibility to hypertension-related end organ damage (renal damage and heart~     failure). It will include cross sectional as well as follow-up studies with a large number~     of subjects and variety of phenotypes, to explore the pathophysiology of hypertension and~     hypertension-related disease.~   "
47847|NCT02430792|"~     Prostate cancer is the most common malignancy in men. Three million are currently living in~     the United States with the disease and this number is expected to rise to four million in~     2024. Most live many years with the disease and experience significant morbidity both due to~     disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce~     treatment toxicity. Moreover epidemiological evidence has suggested that physical activity~     improves survival.~      Football has been shown to induce positive effects on body composition and bone markers in a~     subgroup of prostate cancer patients, those receiving androgen deprivation therapy.~      The objective is to examine the effectiveness of football in prostate cancer survivors.~   "
47848|NCT02430779|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.~   "
47849|NCT02430766|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Lymph Node Metastases.~   "
47850|NCT02430753|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.~   "
47851|NCT02430740|"~     The study objective is to develop a tailored based strategy for ovarian stimulation in IVF~     patients using AMH, BMI, antral follicle count (AFC).~      300 patients will be randomized in 2 arms:~        1. control group: standard care rec FSH.~        2. study group: modified dose of Rec FSH based on AFC with a correction factor based on~          BMI and basal AMH level.~      Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of~     rec FSH used.~      Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B~     and AMH levels during ovarian stimulation.~   "
47852|NCT02430714|"~     This study is a post-marketing surveillance of lenvatinib in participants with unresectable~     thyroid cancer. The objectives of this study are to capture unknown adverse reactions,~     incidences of adverse drug reaction, efficacy, factors considered to have effect to safety~     and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic~     event, and liver disorder.~   "
47853|NCT02430701|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Esophageal Neoplasms.~   "
47854|NCT02430688|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Extremities Neoplasms.~   "
47855|NCT02430675|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Laryngeal Neoplasms.~   "
47856|NCT02430662|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Gallbladder Neoplasms.~   "
47857|NCT02430649|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Prostatic Neoplasms.~   "
47858|NCT02430636|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Stomach Neoplasms.~   "
47859|NCT02430623|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Urinary Bladder Neoplasms.~   "
47860|NCT02430610|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Uterine Cervical Neoplasms.~   "
47861|NCT02430597|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for Hilus Pumonis Neoplasms.~   "
47862|NCT02430584|"~     To obtain whole blood specimens from pregnant subjects to be used for research and~     development and clinical validation studies of prenatal assays.~   "
47863|NCT02430571|"~     This is a prospective, single-center, open label, within-subject clinical trial to evaluate~     the identification of anatomical markers in the gastrointestinal tract using the IRIS~     feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral~     feeding with an anticipated duration of at least 3 days while in an intensive care unit~     (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary,~     written informed consent to participate in the clinical investigation will be included as~     subjects. If a potential subject is incapacitated and unable to provide informed consent, a~     designated legally authorized representative will be allowed to provide the informed consent~     on behalf of the subject to allow their participation in the study. Study entry will be~     defined as the point of signed informed consent. A Prospective, Single-Center, Open Label,~     Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the~     Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology~   "
47864|NCT02430558|"~     Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not)~     within > 18 months, with one or two osteochondral lesions are recruited to have treated~     osteochondral allografts in mosaicplasty.~   "
47865|NCT02430545|"~     The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on~     drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single~     dose of glasdegib in each period.~   "
47866|NCT02430532|"~     The primary objective of the study is to investigate whether treatment with BG00012~     (dimethyl fumarate) compared with placebo slows the accumulation of disability not related~     to relapses in participants with SPMS; The secondary objective of the study is to assess the~     effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and~     cognitive function.~   "
48014|NCT02428569|"~     This study evaluates the effectiveness of patient educational materials (a book and DVD) to~     help patients with chronic kidney disease make early, shared, and informed decisions about~     kidney replacement therapy. Half of the participants will receive the educational materials~     and half will receive usual care from their doctors.~   "
47867|NCT02430519|"~     Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an~     area of complex anatomic morphology difficult to debride by routine periodontal~     instrumentation. Multiple approaches have been used in an effort to treat the furcation~     Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has~     biochemical components which have well known synergetic effects on healing processes. The~     present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin~     (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to~     allograft and guided tissue regeneration (GTR) membrane.~   "
47868|NCT02430506|"~     The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete~     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or~     booster, while not toxic, does not provide much additional protection. AERAS-402 presents~     tuberculosis antigens in the setting of a new, live, replication deficient adenovirus~     vaccine that may increase T cell immunity and thus protection from tuberculosis. Since~     BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,~     AERAS-402 will be administered to individuals in Kenya who have already been vaccinated with~     BCG.~   "
47869|NCT02430493|"~     The primary objective is to describe the safety and tolerability of ticagrelor, by~     assessment of adverse events (characteristics, reporting rate, severity, relationship and~     risk factors), especially the bleeding events as defined in 8.1 and other serious adverse~     events (SAEs) during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.~   "
47870|NCT02430480|"~     Background:~        -  There are several ways to treat prostate cancer. Researchers want to see how well a~          certain kind of imaging helps detect prostate cancer. They also want to see if a~          particular drug combination used before surgery will benefit people with prostate~          cancer that hasn t spread in the body (non-metastatic). The combination will be~          androgen deprivation therapy and enzalutamide.~        -  The combination of androgen deprivation therapy and enzalutamide has been shown to make~          patients with advanced (metastatic disease) live longer. The investigators want to see~          if using it earlier can increase cure rate of surgery and identify genetic or molecular~          characteristics that are associated with better outcomes.~      Objectives:~      - To develop better ways of detecting prostate cancer before and after pre-operative~     treatment.~      Eligibility:~      - Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for~     a radical prostatectomy.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~          They will have scans and X-rays.~        -  Before starting the study drugs, participants will have:~        -  Vital signs taken, medical history, and blood tests.~        -  ECG heart test, with patches stuck on the skin.~        -  Small piece of tumor removed (biopsy) using image guidance from MRI and ultrasound.~        -  3T mpMRI. Participants will lie on a table that slides into a metal cylinder. A probe~          will be inserted in the <TAB>rectum. They will be in the scanner for about 60 minutes,~          lying still. The scanner makes loud knocking <TAB>sounds. Participants will get~          earplugs.~        -  Participants will take the 2 study drugs for 6 months.~        -  Enzalutamide is taken as 4 pills once a day.~        -  Androgen deprivation therapy is given by injection 2 times over 6 months.~        -  During these 6 months, participants will visit the clinic monthly. They will have~          physical exam, vital signs, and blood drawn.~        -  After finishing the study drugs, participants will have another 3T mpMRI. Then they~          will have prostate removal surgery.~   "
47871|NCT02430467|"~     The purpose of this study is to develop more effective ways to help patients and their~     caregivers cope with cancer pain. The investigators are looking at the usefulness of a~     Caregiver-Guided Pain Management Training Intervention versus Pain Education.~   "
47872|NCT02430454|"~     Decisions about ICU beds allocations are made everyday, specially in countries with scarcity~     of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead~     to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that~     external factors may influence the decision making process. The investigators intend to~     evaluate the impact of bed availability and cognitive load on the ICU bed allocation process~     by submitting groups of individuals to a vignette based randomized controlled trial~     simulating conditions with or without increased cognitive load and conditions with or~     without scarcity of ICU beds.~   "
47873|NCT02429388|"~     Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone~     to usual heart failure care versus usual care in patients with acute decompensated heart~     failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose~     spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF~     until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal~     bloating and/or jugular venous distention. Assessment of clinical status and serum~     electrolytes, symptoms and renal function will be performed in accordance to standard of~     care.~   "
47874|NCT02429375|"~     The purpose of this study is to find out how safe and effective treatment with a new~     combination of drugs, mocetinostat and brentuximab vedotin, is in treating cancer. There~     will be 2 parts to this trial: a phase I part and a phase II part.~      Brentuximab vedotin is approved by the U.S. Food and Drug Administration (FDA) to be given~     to patients with Hodgkin Lymphoma. Mocetinostat is an experimental drug that has been given~     to patients with Hodgkin lymphoma in another clinical trial. When given alone, mocetinostat~     caused lymphoma to shrink in about 1 out of 4 patients with Hodgkin lymphoma. This is the~     first study that will give mocetinostat and brentuximab vedotin together.~   "
47875|NCT02429362|"~     Subjects are being asked to donate blood, urine, vaginal secretions and/or tissue to a~     repository for research.This repository will store donated specimens for future research.~     The Department of Obstetrics and Gynecology at the University of Tennessee Health Science~     Center, under the direction of Dr. Giancarlo Mari, Professor and Chair, is responsible for~     the operation of the repository.~      Additionally, in the case of a stillborn child, the mother will be given the opportunity to~     donate samples from her stillborn baby's autopsy to a repository for research.~   "
47876|NCT02429349|"~     The purpose of this study is to assess the results of ovarian tissue freezing, such as~     resumption or initiation of menses (menstruation: the discharge of blood and tissue from the~     uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy,~     prior to starting chemotherapy or radiation treatment (commonly used for cancer treatment or~     for other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females~     who are about to undergo chemotherapy or radiation therapy for cancer or these other medical~     conditions may stop having menses and may not be able to produce a biological child. Girls~     who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or~     radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or~     who have achieved puberty, experience acute ovarian failure in over 50% of the cases. By~     freezing and preserving ovarian tissue will help prevent these outcomes. In fact, when you~     are considered cured of your disease, you will have another surgical procedure where your~     own ovarian tissue will be transplanted back to you. This surgery will increase the~     possibility of resuming/initiating menses and the chance to have a pregnancy.~   "
47877|NCT02429336|"~     The purpose of this study is to collect data that will be generated during an office visit.~     The data will be gathered and analyzed in research studies that will help with the~     investigators understanding of various medical conditions.~      About 200 subjects will be participating in this study. Participation in this study will not~     require a patient's time or presence. The medical information contained in a patient's chart~     from the office visit, including the results of any tests that were ordered at that time,~     will be transferred to an anonymous database and analyzed together with data from other~     patients who have similar condition/s.~      No follow-up information will be collected. The following information will be collected from~     a patient's medical record: the medical history and a list of the current medications.~   "
47878|NCT02429323|"~     Aim of the study is to compare the optimal time needed for successful tracheal intubation~     with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric~     patients undergoing adenotonsillectomy without using muscle relaxants or opioids~   "
47879|NCT02429310|"~     This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device~     to standard treatment of supervised exercise in patients suffering from symptoms and effects~     of lower limb Intermittent Claudication.~   "
47880|NCT02429297|"~     The purpose of the study is to evaluate the feasibility and impact of an automated phone~     system in monitoring and improving self-care and health outcomes among patients with~     diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of~     support from a family member or friend.~   "
47881|NCT02429284|"~     The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical~     course and treatment of patients diagnosed with chronic thromboembolic pulmonary~     hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of~     the Registry will be to promote a greater understanding of the prevalence, pathophysiology,~     evaluation, and treatment of patients with CTEPH through shared information, education, and~     collaborative investigation among pulmonary hypertension (PH) centers of excellence~     throughout the U.S.~   "
47882|NCT02429271|"~     This is a prospective randomized study, which investigates the coronary microvascular~     function as assessed by coronary angiography after administration of ticagrelor compared~     with clopidogrel in patients with myocardial infarction and ST segment elevation after~     thrombolysis.~   "
47883|NCT02429258|"~     Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately~     Controlled With Either Metformin Or Insulin~   "
47884|NCT02429245|"~     The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this~     intervention usually provides a significant improvement in the quality of life of patients.~     However, a significant percentage of patients (up to 30%) are disappointed with the outcome~     of the intervention. One hypothesis that could explain these poor results might be the poor~     positioning of implants. Individual cutting guides are produced after a CT scan response~     planning carried out according to the CT scan anatomy of each patient, and subsequently~     adapted to its real anatomy during surgery, thus theoretically better accuracy of the~     implementation over conventional techniques. It has been shown in the past that the~     navigation has been the gold standard in measuring the three-dimensional orientation of the~     implants during surgery, and this system is systematically used in the service for over 10~     years.~   "
47885|NCT02429232|"~     Diabetes mellitus is a common disease with much impact on human's health and is related to~     osteoporosis. But the mechanism remains unclear. The foreign researches revealed~     thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially~     elderly women. However, it is still controversial in terms of the youth and men. In~     Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.~      This is a multicenter randomized controlled study.~   "
47886|NCT02429219|"~     Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an~     ethanol-containing saline irrigating fluid, prospective detected by breath alcohol~     measurement.~   "
47887|NCT02429206|"~     In the general population, xerosis is often caused by external factors such as seasonal~     changes. In that case, the best way to relieve dry skin is to use a standard moisturizer.~     However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord~     injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because~     of the multiple causes (endogenous rather than exogenous ones) underlying such mobility~     impairment-related skin problems. This study is a double-blind, randomized study with~     positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs~     (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in~     patients suffering of paralysis.~   "
47888|NCT02430428|"~     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl~     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or~     elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or~     without astigmatism) and MRSE ≤ -11.50 D.~   "
47889|NCT02430415|"~     The aim of the study is to compare the effect of the laryngoscope-assisted lightwand~     intubation technique vs. the conventional lightwand intubation technique on the cervical~     spine motion during intubation in patients with the simulated cervical immobilization.~   "
47890|NCT02430402|"~     Young patients with rheumatic diseases have challenges different from older patients due to~     their life situation. It has been reported that they do not have the same benefit from age~     non-specific rehabilitation in warm climate. This trial will test the effect of a specially~     adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian~     young adults aged 20-25 years.~   "
47891|NCT02430389|"~     To identify a better method using a combination of routine anesthetic drugs to improve~     hemodynamic stability during Mayfield head pinning for craniotomy surgery.~   "
47900|NCT02430272|"~     Anticholinergic drugs have traditionally been used for their antisialagogue properties. But~     use of anticholinergic drugs can interfere with thermoregulation via inhibition of the~     parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat~     elimination, and children's thermoregulation depend more on sweating than adults and they~     can become hyperthermic when given these agents.~      The investigators evaluated the fever-causing effects of adjunctive anticholinergics in~     children under general anesthesia using ketamine.~   "
47892|NCT02430376|"~     Background:~      Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as~     large defects in the chest and abdominal wall. This often results in the heart and other~     organs being present outside the body at birth. Surgeons have learned to replace them and~     repair the heart. Researchers want to find possible gene changes that cause POC. To do this,~     they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort.~     The PCGC collects data and DNA samples from people with heart diseases and their families~      Objectives:~      - To find gene mutations in people with Pentalogy of Cantrell (POC) or other related~     syndromes.~      Eligibility:~      - PCGC data and DNA samples that are open to study by the public.~      Design:~        -  Researchers will study the data from the PCGC.~        -  The gene testing being done in this study was consented to in the original studies. No~          new consent or waiver request is required.~        -  The study will last 1 year.~   "
47893|NCT02430363|"~     It is known that after application of MK-3475 activated PD -1 negatively regulates the~     activation of T cells through suppression of the path of PI3K / Akt.~      This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in~     comparison with MK-3475 (pembrolizumab).~   "
47894|NCT02430350|"~     The primary objective of the study is to confirm the efficacy of compound Edaravone~     Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic~     Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the~     safety of compound Edaravone Injection for the AIS patients.~   "
47895|NCT02430337|"~     In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting~     program, will be developed and tested in child welfare. This approach will assist home~     visitors with delivery of SafeCare to families, with the goal of improving provider fidelity~     and implementation success. In the computer-assisted SafeCare sessions, a portion of the~     session will be delivered on a tablet computer that the home visitor brings to the family's~     home. The computer software will deliver the educational piece, or explain piece of each~     session, along with modeling videos of the skills. The home visitor will follow up with the~     practice and feedback portions of the session. A randomized feasibility trial will be~     conducted to test the technology-based approach against the standard SafeCare implementation~     approach in terms of feasibility of implementation, provider job demands and resources, as~     well as client outcomes such as skill acquisition and mental health.~   "
47896|NCT02430324|"~     Traumatic brain injury (TBI) is a leading cause of death and disability worldwide (Ghajar,~     2000). With an estimated annual incidence of up to 500 per 100,000 population and more than~     200 hospital admissions per 100,000 admissions in Europe each year, TBI is a major challenge~     to public health (Lingsma, 2010). Mortality and morbidity after TBI depend on several~     factors, either associated with patients characteristics, the cause of TBI, the neurological~     and general severity and secondary brain insults, the structural brain alterations as~     diagnosed at brain computed tomography (CT) (Rosenfeld, 2012).~      The prognostic value of brain CT characteristics is well documented, including the status of~     basal cisterns, midline shift, the presence and type of intracranial lesions, and traumatic~     subarachnoid hemorrhage (Maas, 2008). Postraumatic cerebral ischemia, which includes~     functionally impaired yet still viable tissue, so-called ischemic penumbra, and irreversible~     cerebral infarction (PTCI), is frequent in patients who die after moderate or severe head~     trauma (Stocchetti, 2014).~      Evidence of antemortem occurrence of PTCI is limited to three single-center retrospective~     studies, reporting a varying prevalence of 1.9%, 8% and 19.1% (Mirvis, 1990; Marino, 2006;~     Tawil, 2008). Increased intracranial pressure (ICP), blunt cerebral vascular injury, need~     for craniotomy and treatment with recombinant activated factor VII, have been demonstrated~     to be risk factors for PTCI. In one study, PTCI was an independent risk factor for poor~     outcome after moderate or severe head trauma with a two-fold increase in mortality and~     severe disability (Marino, 2006).~      PTCI can be an important diagnosis in patients with significant TBI for various reasons.~     First, it might influence long-term outcome. Second, as an outcome that is measurable, and~     relevant to survival and lifestyle, PTCI could be used as an outcome measure in randomized~     controlled trials. Third, diagnosis of PTCI could be used as a standard diagnostic reference~     to validate early surrogate indicators of cerebral ischemia.~      The investigators therefore planned a multi-center prospective study to investigate the~     impact of PTCI on disability at hospital discharge, and on 6-month morbidity and mortality~     in a population of moderate and severe adult TBI patients. The investigators also evaluated~     the role of intracranial hypertension, decreased cerebral perfusion pressure, hypotension~     and other secondary ischemic insults in determining the appearance of PTCI.~   "
47897|NCT02430311|"~     This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in~     combination with paclitaxel in patients with solid tumours. Part A will assess the single~     and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose~     pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety~     of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with~     paclitaxel in Cohort 2~   "
47898|NCT02430298|"~     The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy~     induced oral mucositis and xerostomia and improving quality of life in head and neck cancer~     patients. This is a randomized, double-blind, placebo controlled trial conducted in head and~     neck cancer patients. Mixed-block randomization is used to divide eligible patients into two~     groups: melatonin 40 mg or matched placebo. The patients are required to take the studied~     drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the~     first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5~     fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to~     standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale~     and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and~     adverse event frequency.~   "
47899|NCT02430285|"~     Acute biliary pancreatitis (ABP) is a potentially life-threatening condition caused by~     common bile duct (CBD) stones or sludge, which requires prompt diagnosis and treatment by~     endoscopic removal of the material. Accurate detection of CBD stones is warranted to select~     patients for early therapeutic endoscopic retrograde cholangiopancreatography (ERCP).~      In clinical practice the decision to perform an ERCP is often based on biochemical and~     radiological criteria despite they already have been shown to be unreliable predictors of~     CBD stone presence.~      Endoscopic ultrasound (EUS) is not currently a worldwide standard diagnostic procedure early~     in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and~     cost effective in diagnosing biliary obstructions compared with magnetic resonance~     cholangiopancreatography (MRCP) and ERCP and therefore in preventing unnecessary ERCP and~     its related complications.~      The investigators aim to investigate the clinical usefulness of early EUS in the management~     of ABP.~      All consecutive patients entering the emergency department due to acute abdominal pain and~     showing biochemical and/or radiological findings consistent with possible ABP will be~     prospectively enrolled. Patients will be classified as having a low, moderate, or high~     probability of CBD stones, according to established risk stratification. All enrolled~     patients will undergo EUS within 48 h of their admission. ERCP will be performed immediately~     after EUS only in those cases with proven CBD stones or sludge.~      The following parameters will be investigated: (1) clinical: age, sex, fever; (2)~     radiological: dilated CBD, (3) biochemical: bilirubin, aspartate aminotransferase (AST),~     alanine aminotransferase (ALT), gamma glutamyl transferase (gGT), alkaline phosphatase~     (ALP), amylase, lipases, C-reactive protein (CRP). Association between presence of CBD stone~     at EUS and the individual predictors were assessed by univariate logistic regression.~     Predictors significantly associated with CBD stones (p<0.05) will enter in a multivariate~     logistic regression model.~   "
47901|NCT02430259|"~     Tuberculosis (TB) remains the most important infectious disease in the world. Preventive~     treatment plays an important role in successful control of TB. For preventive therapy, the~     three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now~     recommended by WHO for its non-inferiority, safety and convenience compared with 6~9 months~     regimen of daily isoniazid monotherapy or 3~4 months daily rifampicin monotherapy. And the~     treatment completion rate is higher compared with daily regimen. However, relevant study is~     lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the~     provision of chemoprophylaxis is not recommended in China currently.~      Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an~     open-label, randomized, Phase III clinical trial to evaluate the effectiveness and~     tolerability of the 3RPT/INH to prevent tuberculosis (TB) compared with those who do not~     receive preventive treatment among silicotic patients.~   "
47902|NCT02430246|"~     Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be~     tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV)~     by taking vaginal smear. Treatment will be given according to the results.~   "
47903|NCT02430233|"~     Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational~     weeks will be randomly allocated to receive either vaginal micronized progesterone 400~     mg/day or placebo.~   "
47904|NCT02430207|"~     Temporary pacing via femoral vein is used widely in mainland China, because of its~     feasibility and simplicity. However, pulmonary embolism often occurred after the procedure.~     It is not known that whether there was any difference in incidence of pulmonary embolism~     between via different approaches. This randomized and multi-center study was designed to~     verify whether temporary pacing via subclavian vein has lower incidence than via femoral~     vein.~   "
47905|NCT02430194|"~     An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib With~     Ritonavir Boosting in Patients Chronically Infected With Delta Hepatitis (HDV) (LOWR-2).~   "
47906|NCT02430181|"~     To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in~     Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).~   "
47907|NCT02430168|"~     Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus~     percutaneous nephrolithotomy in 2 to 4 cm kidney stones.~   "
47908|NCT02430155|"~     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide~     reaching as high as 60% in some countries.PPH can also be a cause of long-term severe~     morbidity, and approximately 12% of women who survive PPH will have severe anemia.~      Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth~     and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has~     the potential to produce hemodynamic instability should be considered a PPH. However,~     clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within~     the first 24 hours after delivery and approximately 70% of these cases are due to uterine~     atony. Furthermore, uterine tony is defined as the failure of the uterus to contract~     adequately after the child is born.~      Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach~     including the exclusion of retained products of conception and genital tract trauma. Uterine~     atony, which is the most common cause, the management of uterine atony is an established~     stepwise protocol that in many international guidelines.~      Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as~     excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the~     recommended uterotonic drug for the treatment of PPH.~      If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin,~     intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including~     sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade~     is recommended for the treatment of primary PPH due to uterine atony in women who do not~     respond to uterotonics or if uterotonics are not available.~      Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus~     and inflating it with water could achieve tamponade, case series and other studies have~     suggested that various uterine balloon tamponade(UBT) devices may be effective in treating~     PPH. The studies used various types of UBT devices, including a condom catheter, a Foley~     catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine~     Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success~     rate of UBT does not significantly vary from surgical treatment outcomes.The World Health~     Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the~     American College of Obstetricians and Gynecologists(ACOG), the Royal College of~     Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM)~     recognize balloon tamponade as a method that could significantly improve the management~     intractable PPH, especially in low-resource areas.~      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to~     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH~     due to uterine atony. This recommendation is now stronger than the previous guidelines. It~     can be used for women who do not respond to uterotonics or if uterotonics are not available.~     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a~     higher-level facility.Furthermore, FIGO included UBT as a recommended second-line~     intervention for the treatment of PPH in their updated guidelines issued in 2012.~      Bakri first published the concept of intrauterine balloon technology in the management of~     hemorrhage secondary to placenta praevia-accreta during caesarean section with or without~     bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by~     the American College of Obstetricians and Gynecologists, made mention of the Bakri~     postpartum balloon for its specifically tailored design that enables conservative management~     of uterine bleeding in cases of uterine atony and other causes of PPH.~      The idea of using a condom as a balloon tamponade was first generated and evaluated in~     Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially~     available UBT devices.~   "
47909|NCT02430142|"~     Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry~     system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for~     prognostic value and for associations with tissue hypoxia markers and high central venus~     saturations.~   "
47910|NCT02430129|"~     This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to~     unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee~     osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate~     retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford~     (Warsaw, IN) mobile bearing unicompartmental knee arthroplasty.~      Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index~     (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis~     from the investigating gait lab.~      The investigators hypothesize that post-operative UKA patients will display higher clinical~     scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The~     investigators further hypothesize that the biomechanics data will assist in the~     understanding of the outcome score differential both pre- and post-operatively in both~     groups, as well as between-groups.~      Total follow up period will be two years.~   "
47911|NCT02430116|"~     Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the~     most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve~     replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can~     inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes~     and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.~      Methods: A total of 36 New York Heart Association class II or III patients with rheumatic~     heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac~     valve replacement with CPB in the investigators' hospital from February 2014 to May 2015,~     were randomly divided into the following three groups (n=12 each): negative control group~     (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the~     procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and~     cross-clamping for 30 s for three cycles, after which the ascending aorta was completely~     opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for~     arrhythmia and recovery of myocardial contractile function after reperfusion by~     electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of~     the right atrial appendage were obtained at 3 min before CPB was established in the NEG~     group, and at 45 min after opening the aorta in the POS and Treat groups. In all three~     groups, the myocardial tissues of the right atrial appendage were obtained and preserved at~     −80°C for further experiments. The right atrial appendage of three patients randomly~     selected in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge~     tube overnight at 4°C, and then preserved at −20°C for RNA extraction. Human 12×135K Gene~     Array profiling of mRNA expressions was undertaken in human cardiac muscle cells.~     Differentially expressed mRNAs verified by quantitative real-time RT-PCR were subjected to~     pathway analysis. The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9,~     caspase-6, caspase-7, BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western~     blot analysis. The levels of myocardial apoptosis induced by I/R were investigated by TUNEL~     assays. The changes in MIRI induced by myocardial apoptosis were investigated by pathologic~     examination of the myocardium.~   "
47912|NCT02430103|"~     The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist~     (goserelin) on the preservation of ovarian reserve function in breast cancer patients of~     reproductive age treated with (neo)adjuvant chemotherapy by serial measuring the biochemical~     marker AMH pre and post chemotherapy~   "
47913|NCT02430090|"~     45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to~     march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15~     µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal~     administration. Hemodynamic parameters, characteristics of sensory and motor blockade,~     peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the~     first analgesic requirement and adverse effects were recorded.~   "
48038|NCT02428257|"~     The study evaluates the potential beneficial effects on hemodynamics when hypobaric~     bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for~     surgical repair of hip fracture in elderly patients. Half of the patients will receive~     hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic~     data will be compared.~   "
47914|NCT02430077|"~     Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and~     predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a~     common complication in patients with partial and generalized lipodystrophies.Despite~     aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its~     complications present a therapeutic challenge in many patients. Due to this large disease~     burden, it is important to assess the efficacy and safety of novel therapies for hepatic~     steatosis in patients with lipodystrophies.There are, however, no systematic studies~     evaluating various therapeutic interventions for reducing hepatic steatosis in patients with~     lipodystrophies. A variety of drugs have been investigated in nonlipodystrophic patients~     with non-alcoholic hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver~     disease (NAFLD). Recent data support the activation of the farnesoid X receptor (FXR,~     NR1H4), a nuclear hormone receptor regulated by bile acids, for treatment of NASH and NAFLD.~     FXR activates transcription of several genes particularly the atypical nuclear receptor~     small heterodimer partner (SHP, NR0B2) and thus can influence triglyceride metabolism within~     hepatocytes.Both cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR,~     however, UDCA which is the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic~     acid (OCA) is a first-in-class selective FXR agonist which has approximately 100 fold~     greater FXR-agonistic activity in the nanomolar range, as compared to CDCA .It therefore~     appears that FXR modulation offers interesting therapeutic possibilities in treating hepatic~     steatosis. This study is primarily designed to study efficacy of OCA, a strong FXR ligand,~     in reducing hepatic triglyceride levels in patients with hepatic steatosis and Familial~     Partial Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and~     mortality as a result of sequelae of hepatic steatosis in patients with lipodystrophies.~   "
47915|NCT02430064|"~     This study aims to investigate the effects of diets enriched or depleted in foods at high~     risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and~     cardiometabolic risk in healthy men. The study design is an interventional diet study, with~     7 days dietary advice to avoid processed foods, followed by 4 days in which lunch and~     evening meal are provided to volunteers. Anthropometric and blood markers of cardiovascular~     disease risk are measured at the start and end of each dietary phase. The aim is to gain an~     improved understanding of how processed foods modify risk of cardiometabolic disease.~   "
47916|NCT02430051|"~     The goal of this project is to examine the efficacy of a sensory adapted dental environment~     (SADE) for children who have difficulty tolerating oral care in the dental clinic. The~     investigators hypothesize that adapting the sensory environment in the dental office by~     modifying the sounds, sights,and tactile experiences will result in decreased anxiety,~     increased cooperation, and fewer behavior problems for children with Autism Spectrum~     Disorders (ASD), as well as for typically developing (TD) children especially those who have~     dental anxieties or sensory sensitivities. This has the potential to contribute to increased~     child comfort as well as safer, more efficient, and less costly treatment for a large~     population, as potentially more than one-fourth of all children may benefit from a sensory~     adapted dental environment.~   "
47917|NCT02430038|"~     This is a prospective observational study of transperineal ultrasound between 24-42 weeks~     gestation and a prospective longitudinal observational study in all term (37-42 weeks)~     labouring women.~   "
47918|NCT02430025|"~     This proposal delineates a research plan to collect blood from the patients with~     cardiovascular diseases for the purpose of establishing a molecular biological bank~     registry. The Fujian provincial hospital will enroll 8,000 patients.The blood collected will~     be processed to create a repository of molecular biological plasma. Along with a sample of~     blood collected from individual patients, a concise general medical history, demographic~     data, electrocardiographic data, echocardiographic data, and laboratory data will be~     collected. A short interview will take place after enrollment during the outpatient visit or~     hospital stay, or may be conducted via phone call after enrollment. All the clinical data~     gathered will be compiled in Fujian provincial hospital center database, and would be stored~     in a format where a culmination of clinical findings, i.e. representing a disease of~     interest, can be used to search the database to identify the blood samples of all patients~     with such characteristics for further study.~   "
47919|NCT02430012|"~     The investigators have identified underuse of secondary prevention medications at discharge~     of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study~     is to develop series of quality improvement strategies focusing on secondary prevention~     medications for patients underwent CABG, and to evaluate their effectiveness and safety via~     a hospital-level cluster randomized clinical trial. The investigators established a network~     of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and~     submitted 50 or more CABG surgeries already. The participating sites will be divided into~     intervention and control groups in a 1:1 ratio. The intervention group will undertake~     intervention of quality improvement strategies, while the control group will maintain the~     routine practice pattern. All hospitals will consecutively enroll and submit data of CABG~     during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin~     converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers,~     statins and aspirins will be compared between 2 groups.~   "
47920|NCT02429999|"~     Infertility in not a health problem and that infertile couples are not really ill. However,~     this narrow interpretation of the problem is refuted by the world community. The WHO defines~     health as a state of complete physical, mental and social wellbeing and not merely the~     absence of disease or infirmity. It has also been argued that overpopulation is the main~     problem in the developing countries and that helping infertile couples contradicts the~     interests of the countries and the world at large. However, this narrow approach contradicts~     human rights in general and reproductive rights in particular.~      In 1994, the United Nations International Conference on Population and Development in Cairo~     mentioned issues on future actions on 'prevention and appropriate treatment of infertility~     where feasible'. However, no guidelines or concrete actions and programmes were given for~     developing countries.~      Worldwide, more than 80 million couples suffer from infertility; the majority of this~     population are residents of developing countries.~      In September 2001, a meeting on 'Medical, Ethical and Social Aspects of Assisted~     Reproduction' was organized by the WHO. For the first time, major attention was paid to~     ongoing developments in assisted reproduction technology together with their social and~     ethical implications in developing countries . It was the first time that the WHO~     highlighted the issue of assisted reproduction in developing countries.~      ART in developed countries is highly expensive one of steps is ovulation induction the most~     common protocol for induction is the long gonadotrophin-releasing hormone (GnRH) agonist~     pituitary suppression regimen combined with relatively high doses of exogenous~     follicle-stimulating hormone (FSH) remains the most frequently used stimulation protocol~     which is expensive. in our study we will use a mild ovarian stimulating protocol letrozole~     adjuvant to gonadotrophins which is less expensive~      The use of aromatase inhibitor have only recently been introduced in infertility treatment,~     especially for ovulation induction.~      An aromatase inhibitor blocks the conversion of androgens to estrogens in the ovarian~     follicles, peripheral tissues, and in the brain. This result in two things: (a) Fall in~     circulating and local estrogens and (b) Rise in intraovarian androgens. Fall in estrogen~     levels, releases the hypothalamopituitary axis from the negative feedback of estrogens.~     Thus, there is a surge in follicle stimulating hormone (FSH) release, which results in~     follicular growth. Since, the feedback mechanism is intact; normal follicular growth,~     selection of dominant follicle, and atresia of smaller growing follicle occurs; and thereby~     facilitating monofollicular growth and ovulation.Another mechanism of action of the~     aromatase inhibitors is by the increasing intraovarian androgens. This increases the~     follicular sensitivity to FSH. Recent data shows the role of androgens in early follicular~     developments. by augmenting FSH receptors and stimulating insulin-like growth factor~     (IGF)-I; FSH and IGF-I act synergistically to promote follicular growth. This~     pharmacodynamics of letrozole ensures improved endometrial thickness, cervical mucus,~     monofollicular, and better folliculogenesis. So , these factors may lead to higher pregnancy~     rates and greater likelihood of singleton pregnancy.~      Letrozole has been tried for ovarian stimulation for assisted reproduction. With the concept~     of mild stimulation in IVF to improve implantation rate, letrozole is a potential agent.~     Letrozole has two potential uses in IVF: First, where it is used in the follicular phase~     usually with FSH/human menopausal gonadotropin (HMG) for ovulation induction; second, it has~     also been used in luteal phase of stimulated IVF cycle and to reduce circulating E2 levels;~     thus, potentially reducing ovarian hyperstimulation syndrome (OHSS) risk.~      A significant reduction in the total dose of gonadotrophins was found when aromatase~     inhibitor was added in controlled ovarian hyperstimulation (COH) cycles.~      Some studies evaluated the addition of letrozole in patients with normal ovarian response~     undergoing IVF or Intracytoplasmic sperm injection( ICSI). They showed higher implantation~     and ongoing pregnancy rates in the letrozole cotreatment group.~   "
47921|NCT02429986|"~     Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be~     reimbursed according to the French Social Security rules, the patient treated with an ASV~     needs to be examined each year. In this observational transversal single-visit study, the~     investigators aim to describe the clinical characteristics of patients treated with ASV and~     the associated device settings.~   "
47922|NCT02429973|"~     Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of~     metastatic osteosarcoma. The study includes 6 cycles of the combination~     gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.~   "
47923|NCT02429960|"~     Until today there is no standard-monitoring to specifically reflect the analgesic component~     of general anesthesia. Quality and safety of general anesthesia are of major clinical~     importance and can be improved by limiting the administration of opioid analgesics to the~     minimum dose needed. This study therefore examines the quality of three different monitoring~     techniques (PhysioDoloris, MetroDoloris, Lille, France, SPI (Surgical Plethysmographic~     Index), GE Healthcare, Helsinki, Finland and AlgiScan, IDMed, Marseille, France) in~     assessing the level of analgesia during general anesthesia. Therefore a standardized painful~     stimulus is applied under different levels of analgesic drugs. The monitor's indices are~     compared to clinical signs such as an increase in heart rate and blood pressure.~   "
47924|NCT02429947|"~     The purpose of this study is to identify the issues that have greatest impact on QOL for~     patients with Charcot Marie Tooth (CMT) Disease. Patients who have -registered in the~     Inherited Neuropathies Consortium Contact Registry will be invited to participate.~   "
47925|NCT02429934|"~     This research trial is for patients who have been diagnosed with systemic lupus~     erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis)~     because of the SLE.~      The purpose of this clinical research study is to evaluate the safety and effectiveness of~     treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly~     for 16 weeks versus placebo injections(a substance with no active ingredients and therefore~     may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The~     effectiveness will be assessed primarily by the number of swollen, tender joints (called a~     joint count) at each of study visits.~      Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by~     prescription and has not been approved by the U.S. Food and Drug Administration for treating~     SLE yet.~      In this study, subjects will receive treatment with either abatacept or placebo once a week~     for 16 weeks (a total of 16 injections).~   "
47926|NCT02429921|"~     About 45 million people in Bangladesh are chronically exposed to unacceptable levels of~     arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular~     diseases.~      This dietary trial intends to test the potential of high-selenium lentils, consumed as~     lentil soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and~     in improving the overall health status.~      Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils~     (50g/person/day) that are naturally high in selenium, the other group will receive lentils~     with low selenium content. This 6 months trial is randomized and double-blinded.~   "
47927|NCT02429908|"~     This study is a post-market clinical follow-up study to fulfill the post-market surveillance~     obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The~     data collected from this study will serve the purpose of confirming safety and performance~     of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective~     in reducing patient disability.~   "
47928|NCT02429895|"~     A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic~     Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized~     Controlled Trial (RCT).~   "
47929|NCT02429882|"~     The purpose of this study is to assess the safety and efficacy of brodalumab compared with~     placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1~     ratio to brodalumab or placebo for the first part of the study. Subjects will then receive~     open label brodalumab for the remainder of the study. The entire study will be 312 weeks in~     duration for each subject.~   "
47930|NCT02429869|"~     Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR~     inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR~     inhibition may favorably impact the HIV viral reservoir, and we hypothesize that adding~     everolimus to the transplant immunosuppressive regimen of HIV positive transplant recipients~     will decrease HIV persistence in CD4+ lymphocytes.~   "
47931|NCT02429856|"~     This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior~     Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee~     Arthroplasty (TKA) as the primary outcome.~   "
47932|NCT02429843|"~     This is a single center, open-label, nonrandomized, phase 1b study of TRC105 in combination~     with standard dose treatment in patients with stage IV non-squamous non-small cell lung~     cancer.~   "
47933|NCT02429830|"~     The purpose of this study is to evaluate the LINX device in patients who have previously~     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic~     gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux~     symptoms.~   "
47934|NCT02429817|"~     Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in~     routine use in intensive care unit. However, jet nebulizers remain the most frequently used~     nebulizers.~      On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased~     using a vibrating-mesh nebulizer as compared to a jet nebulizer.~      Lung distribution of nebulized particles delivered through a HFNC has never been~     investigated in vivo. The aim of this study was to compare aerosol lung distribution with~     both nebulizers through a HFNC by SPECT-CT.~   "
47935|NCT02429804|"~     This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/~     fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging~     (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating~     patients with prostate cancer that has not responded to hormone therapy and has spread to~     other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors~     accurately measure how well patients respond to treatment with radium Ra 223 dichloride.~   "
47936|NCT02429791|"~     The aim of this study is to determine if virologically suppressed human immunodeficiency~     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside~     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon~     switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will~     primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily~     compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch~     visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR~     will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse~     transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a~     148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52)~     and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study~     eligibility criteria will participate in the Early Switch Phase where they will either~     switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end~     of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all~     participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until~     Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the~     Continuation Phase. The study is planned to be conducted in approximately 476 participants.~   "
48095|NCT02427516|"~     To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations,~     consultations, medications, and tests) of adequately controlling a patient (i.e. INR between~     2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous~     thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.~   "
47937|NCT02429778|"~     The PI developed a self-directed program to treat late-life anxiety called Breathing,~     Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This~     program consists of weekly video lessons that participants watch on digital video disc (DVD)~     along with weekly telephone check-ins. In BREATHE participants will learn two behavioral~     interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose~     of the study is to examine whether the self-directed BREATHE program is superior to a wait~     list control in reducing anxiety in older adults with anxiety disorders. For those assigned~     to wait list control, they will be offered opportunity to participate in BREATHE treatment~     after 8 weeks of wait list.~   "
47938|NCT02429765|"~     A number of studies have documented poor sleep quality and troublesome symptoms~     (breathlessness, cough and sputum production) upon awakening in patients with COPD. However,~     the investigators know very little about measurements of respiratory mechanics (i.e., lung~     volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The~     investigators also know little about how modern bronchodilator therapies, or the timing of~     when they are taken, affect respiratory mechanics during sleep or the severity of early~     morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications~     which are used to open up airways and make it easier for air to get in and out of the lungs.~     The investigators are studying the effects of a new inhaler that contains two different~     types of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and~     aclidinium bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial~     studies have shown that this combination therapy taken twice daily can improve some lung~     function measurements and respiratory symptoms in patients with moderate to severe COPD.~     There are also reports that evening administration of this medication may provide important~     advantages in patients with dominant nighttime and early morning symptoms. It is thought~     that sustained bronchodilation and lung deflation during the night may improve respiratory~     mechanics, diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce~     severity of morning symptoms. This study will be the first to explore the effects of a~     nighttime dose of aclidinium/formoterol combination therapy on detailed measurements of~     respiratory mechanics and early morning symptoms in COPD. This study will also give us a~     better understanding of the mechanisms of early morning respiratory symptoms and their~     improvement with bronchodilators.~   "
47939|NCT02429752|"~     The goal of this study is to identify if there is a significant prevalence of abnormal~     respiratory patterns in a sample of patients with low back pain (LBP), and if the presence~     of abnormal respiratory patterns are predictive of rehabilitation outcomes in this~     population. In addition, the investigators will assess the response to inspiratory muscle~     training (IMT) for a subgroup of subjects that maintain abnormal breathing patterns after 1~     month of physical therapy. Patients seeking physical therapy for LBP within the Uhealth~     system will be recruited. The first phase of this study will be observational. A~     comprehensive assessment of their respiratory function will be performed at the beginning of~     their therapy and after 1 month of therapy. Subjects that demonstrate abnormal respiratory~     patterns after 1 month of therapy will be offered the opportunity to participate in the~     second phase of the study in which they will receive 1 month of inspiratory muscle training~     (IMT). The respiratory assessment will then be repeated at the end of the IMT training~     program.~   "
47940|NCT02429739|"~     The main aim of this interventional study is to investigate whether the effects of~     computerized working memory training improves reading abilities for children, i.e. ages 9 -~     16 years, diagnosed with dyslexia.~   "
47941|NCT02429726|"~     Objective of this study is to investigate of efficacy and safety of recombinant adenoviral~     human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin.~     This is a phase 2, double blinded, randomized, active controlled study.~   "
47942|NCT02429713|"~     Tourniquets are still widely used in total knee arthroplasty, but are associated with~     several adverse effects. Most of previous studies did not randomize the participants so the~     baseline difference of the patients might have influenced the outcome. Therefore,~     investigators conducted a randomized controlled trial, in which all the patients received~     staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to~     quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of~     tourniquet use on functional and clinical outcome.~   "
47943|NCT02429700|"~     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has~     the same curative effects and less adverse effects than bleomycin, etoposide and~     cisplatin(BEP) among newly diagnosed ovarian malignant sex cord-stromal tumor patients after~     surgery.~   "
47944|NCT02429687|"~     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has~     the same curative effects and less adverse effects than bleomycin, etoposide and~     cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after~     surgery.~   "
47945|NCT02429674|"~     The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents~     (IPT-A) with depression works to change sleep and related biological markers found in~     saliva, namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this~     project is to understand the biological mechanisms of recovery from depression in order to~     assist in selecting and guiding personalized psychotherapeutic interventions with the~     highest likelihood of success for individual adolescents with depression.~   "
47946|NCT02429661|"~     The purpose of this study is to determine the social, emotional, physical, and educational~     effects of Girls First, a combined resilience and adolescent health program, vs. its~     components and a control group, among adolescents in India.~   "
47947|NCT02429648|"~     The purpose of this study is to compare which strategy is superior in patients with~     persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current~     cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein~     isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if~     the patient remains in atrial fibrillation.~   "
47956|NCT02429531|"~     Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency~     characterized by a deficient antibody production to capsular polysaccharides with normal~     total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections~     and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting~     other components of the immune system. Diagnosis of SPAD is hampered by difficulties with~     the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to~     assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers~     as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody~     deficiency.~   "
47957|NCT02429518|"~     This study is a Phase 4, open-label, single group study in which at least 40 adult patients~     undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be~     assessed by 12-lead ECG for prolongation of the corrected QT interval~   "
47948|NCT02429635|"~     The aim of this research study is to assess the effectiveness of an intervention on exercise~     and health, and to contribute to the understanding of how team-based worksite health~     promotion programs should be designed in order to increase and maintain exercise among~     employees. The study design is a randomized controlled trial.~      There are a number of different theories on the subject of how to affect motivation for~     health behavior change. This study is based on the tenets of Self-Determination Theory (SDT)~     in combination with elements from Motivational Interviewing and in accordance with the~     Health Promotion Guidelines developed by the National Institute of Health and Clinical~     Excellence, NICE.~      It is assumed that if such a program is designed and offered in a manner that satisfies the~     participants' sense of autonomy, competence and relatedness, this will affect the quality of~     the participants' self-regulated motivation and perceived competence for exercise and~     lifestyle changes. As a consequence, a large proportion of the participants will adhere to~     the program and increase their exercise both in the short (5 months) and long term (8~     months).~      The following research questions will be:~        1. Would a team-based health and exercise promotion intervention designed to be needs~          supportive, relative to a control group:~             1. Influence increases in exercise levels, improved aerobic fitness, reduced blood~               pressure, and decreases in waist circumference, and Body mass index (BMI), in~               addition to changes in body composition in terms of reduced percentage of fat and~               increased percentage of muscles?~             2. Influence increases in psychological well-being?~             3. Influence increases in perceived investment in employees' health competence, which~               would positively predict affective organizational commitment and job performance,~               and negatively predict turnover intentions?~             4. Influence decreases in sickness absenteeism?~        2. If so, would changes in psychological needs support, autonomous motivation for~          exercise, perceived competence and self-efficacy in exercise mediate these effects?~   "
47949|NCT02429622|"~     This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT~     simultaneous integrated boost technique with or without concurrent chemotherapy for locally~     advanced esophageal carcinoma.~   "
47950|NCT02429609|"~     The measurement of visual acuity is made using black letters of varying size superimposed on~     a uniform white background. The objective is to determine the smallest letter, or optotype,~     that can be correctly identified. One limitation of current tests is the variability of~     measurements, this making it difficult for clinicians to determine if changes in visual~     acuity are related to ocular disease. This variability has been attributed to the design of~     current optotypes, in particular their differing legibilities. Our group has recently~     demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters~     with a black core and a white border presented on a grey background, reduces the variability~     of visual acuity measurements. In this study the investigators wish to determine if changes~     in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular~     shape, may be detected more easily using the Moorfields Acuity Chart compared with~     conventional letter charts.~   "
47951|NCT02429596|"~     Background. Anecdotal reports and uncontrolled studies have described an association between~     generic substitution of antiepileptic drugs (AEDs) and adverse events, including loss of~     seizure control. Although these results are likely to be influenced by methodological bias,~     they have led to a strong opposition, among physicians and patients, to the use of generic~     products in epilepsy.~      Objectives. The primary objective is to assess potential risks associated with substitution~     of the currently taken AED product with an equivalent product, using as endpoint changes in~     serum drug levels at steady-state after substitution compared with baseline. Secondary~     objectives will be the assessment of inter-subject variability in serum drug concentration~     on an unchanged treatment schedule, and evaluation of potential short-term changes in~     seizure control and adverse events rate.~      Methods. The study will use an experimental randomized open-label non-inferiority design.~     The population will consist of 200 adults stabilized on chronic treatment with~     carbamazepine, valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine and~     admitted to hospital for diagnostic evaluation or other indications, with no expected~     treatment changes during the subsequent 5 to 6 days. Patients will be randomized to two~     groups. One group will continue to receive the AED products used before enrollment (brand or~     generic), whereas the other group will be switched to an alternative equivalent product.~     Dosing schedules of the AEDs being tested as well as comedications will be unaltered~     throughout the 6- to 7day period of the study. Serum AED levels (mean of two values obtained~     at peak and trough, respectively in the evening and the next morning) will be measured on~     day 1 (baseline) and 5 days post-randomization (6 days for patients receiving AEDs with~     half-lives above 12 h). The primary outcome endpoint will be the proportion of patients who,~     post-randomization, show a greater than 25% change in serum drug concentration compared with~     baseline. Secondary endpoints will include comparison of distributions of rough serum~     concentration changes between groups, other pharmacokinetic parameters, time to first~     seizure, total number of seizures, and adverse events.~   "
47952|NCT02429583|"~     This study will investigate the effects of chronic HCV infection and corresponding innate~     immune activation on the immune response to HBV vaccination. We will recruit chronic HCV~     patients and healthy control patients for HBV vaccination. We will use RNA Sequencing~     (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all~     genes, to determine patients' innate immune status, and learn how this innate immune~     signature is related to HBV vaccine response. We will then explore the mechanisms by which~     chronic HCV infection affects different immune cells and functions that are known to be~     important for an effective HBV vaccine response. These studies will enhance our~     understanding of the immune effects of chronic viral infection, establish factors that~     determine effective vaccine responses, and help guide vaccination strategies for HCV~     patients and other individuals with chronic inflammatory disease.~   "
47953|NCT02429570|"~     Cancer that has spread to the brain, or brain metastasis, is difficult to treat.~     Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the~     laboratory. This medicine has been used in the past to treat pain. But, in this study, it~     will be used to prevent new brain metastasis. This is the first time that meclofenamate will~     be used in patients with brain metastasis.~      This is a pilot study which means that the purpose of this study is to determine if a larger~     clinical trial of meclofenamate is possible in patients with brain metastasis. This study~     also aims to find out what effects, good and/or bad meclofenamate has on the patient and the~     cancer that has spread to the brain. The investigators also want to learn more about~     potential effects that this drug may have in the digestive system.~   "
47954|NCT02429557|"~     Compression garments have been shown to be effective in the treatment of orthostatic~     hypotension in autonomic failure patients. The purpose of this study is to determine the~     hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing~     blood pressure and orthostatic tolerance in these patients, and to compare them with those~     of the standard of care midodrine. The investigators will test the hypothesis that abdominal~     compression will blunt the exaggerated fall in stroke volume and the increase in abdominal~     vascular volume during head up tilt.~   "
47955|NCT02429544|"~     The goal of this behavioral research study is to compare 2 different types of residential~     group programs to help researchers learn if and how well these groups may help to improve~     physical and emotional well-being in patients with stage IV breast cancer.~   "
47958|NCT02429505|"~     This study is a prospective observational study in which patients undergoing treatment for~     leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to~     provide information about their clinical response to treatment up to 6 months after the~     start of treatment.~   "
47959|NCT02429492|"~     Amyotrophic lateral sclerosis (ALS) is due to neurodegeneration of upper and lower motor~     neurons, leading to muscle atrophy, paralysis and death. However, there is growing evidence~     that interneurons involved in the gain regulation of spinal motoneuron (lower motor neurons)~     and in sensorimotor integration may participate in the pathogenesis of ALS. While sensory~     afferents in the peripheral nerve are traditionally thought to be unaffected at the~     beginning of the disease, diffusion MRI has revealed degeneration and demyelination of the~     posterior columns in the spinal cord of patients recently diagnosed with ALS, and there are~     sporadic reports of sensory involvement. Early alteration of the sensorimotor integration~     could participate to the degeneration of motor neurons and interneurons. The goal of the~     project is to further investigate sensorimotor integration at spinal level in human patients~     recently diagnosed with ALS, and to study whether an interneuron pathology could participate~     in ALS pathogenesis.~      Our project has first an interest for the fundamental research aiming at increasing basic~     knowledge of pathophysiology of ALS, and specifically on the functional effects of the~     underlying neurodegenerative mechanisms. By testing the excitability of spinal interneurons~     in patients recently diagnosed, and by doing so for clinically uninvolved muscles, we will~     be able to evaluate whether an interneuron pathology could be involved in ALS. Our results~     will help to understand better the chain reactions in the neurodegenerative processes that~     dramatically evolve until the death of all motor neurons. Our project has also an interest~     for the development of therapeutic approaches for ALS. Indeed, our methods will help to~     determine specific electrophysiological biomarkers that will help to evaluate quantitatively~     spinal and corticospinal neural processes: their changes during the course of the disease~     (follow-up study), the effect of therapeutic agents and/or rehabilitation methods on their~     excitability, and their repercussions on motor neuron activity (evaluation of therapeutics).~     Lastly, our methods could be tested in other neuromuscular diseases to determine possible~     differences in spinal neural activity. Indeed, the motor dysfunction common to several~     neuromuscular diseases can make it difficult to make a definitive diagnosis. The development~     of specific biomarkers is crucial for an early diagnosis, and to evaluate the best treatment~     for the patients as rapidly as possible.~   "
47960|NCT02429479|"~     The overarching goal of the project is to improve the process and experience of surrogate~     decision-making by family caregivers. Since feeling unprepared to make surrogate decisions~     is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy~     --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a~     surrogate decision-maker.~   "
47961|NCT02429466|"~     This is an open-label, single arm, Phase I dose escalation study in subjects with refractory~     germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in~     combination with cisplatin in subjects with rGCT. The primary objective is to determine the~     maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15~     subjects will be enrolled in this study at the Indiana University Simon Cancer Center.~   "
47962|NCT02429453|"~     The goal of this study will be to determine whether PCC confers any benefits over FFP in~     traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including~     time to correction, absolute international normalized ratio correction amount, cost, need~     for surgical intervention, and radiographic bleed expansion through a prospective,~     randomized control trial.~   "
47963|NCT02429440|"~     Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic~     adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage~     colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer~     (RCC).~   "
47964|NCT02429427|"~     It has been found that the chemical changes that take place in a patient's body during the~     development of inflammation may provide an environment which stimulates cancer cells. One~     step in the development of inflammation is the production of certain chemical substances~     which are important in the formation and spread of tumours. These are called prostaglandins.~     Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the~     body) involved in the production of these prostaglandins and although it is not usually~     present in most tissues it is made at the sites of inflammation. Celecoxib is a selective~     Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2~     enzyme, leading to a decrease in the production of prostaglandins and a reduction in~     inflammation.~      The purpose of this study is therefore to find out if celecoxib can be used after breast~     cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce~     the ability of new tumours to grow and survive.~      2590 women with primary breast cancer will be recruited in this study from several locations~     in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment~     group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg~     daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor~     positive patients will receive endocrine treatment as per local practice. Patients will~     prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed~     or if patients experience unacceptable toxicity.~      Patients will be seen every 6 months for the first 3 years and then off treatment follow-up~     is carried out annually. Participating patients will also be given the option to take part~     in the pathology sub-study by donating a sample of the tumour tissue collected at the time~     of the primary surgery.~   "
47965|NCT02429414|"~     The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy~     (FOB -- also known as a fiberoptic scope procedure) needs to be used with a video double~     lumen tube (VDLT) during surgeries that require lung isolation. On this study, you will have~     one of 2 types of commonly-used breathing tubes used, either a VDLT or a non-video double~     lumen tube (called a non-video DLT). An FOB may or may not be performed, as described below.~      The level of effectiveness of the VDLT and non-video DLT will be compared.~   "
47966|NCT02429401|"~     In this comparative-effectiveness study, investigators will recruit 400 English-speaking,~     Spanish-speaking, or bilingual heavy-drinking Mexican-origin men admitted to a community~     hospital for medical treatment of an alcohol-related injury or heavy drinking. Participants~     will be randomized to receive a culturally adapted brief motivational intervention (CA-BMI)~     or a non-adapted brief motivational intervention (NA-BMI). The primary outcomes of interest~     include alcohol use, alcohol problems, and treatment utilization. Secondary outcomes include~     therapeutic alliance ratings and social support. Telephone follow-up assessments will be~     completed at 3, 6, and 12 months post-treatment.~   "
47967|NCT02429193|"~     This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with~     castration-resistant prostate cancer. Sixteen patients will be enrolled over 18 months.~   "
47968|NCT02429180|"~     A pilot study that will evaluate the feasibility and acceptability of procedures to inform~     the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and~     cost effectiveness of ReTrain for stroke survivors).~   "
47969|NCT02429154|"~     The purpose of this study is to show that a permissive hypercapnia during mechanical~     ventilation in children under general anaesthesia will improve cerebral perfusion.~   "
47970|NCT02429141|"~     In the transarterial technique for axillary brachial plexus block, the axillary artery is~     intentionally punctured to indicate placement of the needle within the neurovascular sheath;~     local anesthetic is then injected deep and superficial to the axillary artery.~   "
47971|NCT02429128|"~     The aim of this project is to investigate the pathophysiology of PCOS in regards to the~     metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose~     tissue, and to investigate the effects of exercise training on these parameters.~   "
48415|NCT02423343|"~     The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     study drug known as galunisertib in combination with nivolumab in participants with advanced~     refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC),~     hepatocellular carcinoma (HCC) or glioblastoma.~   "
47972|NCT02429115|"~     Receiving supportive mentoring from well-adjusted individuals who share similar experiences~     has had a positive influence on adjustment with some chronic diseases. In this study,~     patients with advanced chronic kidney disease and caregivers of such patients will be~     randomly assigned to one of three groups: (1) face-to-face PFPP—individuals will receive six~     months of PFPP peer-mentoring, along with an informational text; (2) online PFPP—individuals~     will receive six months of online peer-mentoring modeled after the PFPP program, along with~     an informational text; and (3) information-only control group—individuals will receive the~     text of the material provided to the other two groups. The study team's decision to include~     an online version is based on suggestions by previous participants who indicated that this~     would be convenient for individuals for whom distance and geographic location are major~     considerations of participation.~      The investigators expect that both face-to-face and online peer-mentorship programs will~     result in improved quality of life among patients with advanced kidney disease and decreased~     feeling of burden among caregivers of these patients. The investigators also expect that~     mentorship will lead to improved engagement of patients in their own care.~   "
47973|NCT02429102|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     MT-8554 in healthy Caucasian subjects.~   "
47974|NCT02429089|"~     In this trial, the investigators would like to investigate the activity of LEE011 associated~     with cetuximab (standard of care for the SCCHN patients at this stade of the disease).~   "
47975|NCT02429076|"~     The aim of this study is to test the hypothesis that methylphenidate actively induces~     emergence from propofol and sevoflurane general anesthesia in healthy volunteers.~   "
47976|NCT02429063|"~     Fatigue is one of the most consistent and distressing symptoms reported by pediatric~     oncology patients. The investigators' work has demonstrated that in the period from~     diagnosis through the initial 8 weeks of treatment, adolescents and young adults with solid~     tumors experience substantial fatigue that is not related to sleep disruption. Fatigue can~     contribute to many adverse outcomes including poor treatment adherence, reduced social~     activities, depressive symptoms, behavior problems, and poorer quality of life.~     Unfortunately, no definitive intervention to reduce fatigue has been developed for pediatric~     oncology patients. Investigators propose a study to estimate the feasibility and~     acceptability of bright light therapy as an intervention to decrease fatigue in adolescents~     and young adults who are newly diagnosed and receiving treatment for solid tumors, including~     lymphoma.~   "
47977|NCT02429050|"~     Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary~     Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is~     recommended in clinical practice guidelines, but questions concerning benefits and concerns~     about respiratory adverse effects remain. For example, the effect on health-related quality~     of life and functional capacity is unknown. In one-third of the patients oral sustained~     release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether~     severity and descriptors of breathlessness may predict a response to morphine. Finally,~     cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription~     of morphine to patients with COPD is limited.~      Objectives of this double blind randomized controlled trial are to study the effect of oral~     administration of morphine SR on health-related quality of life, respiratory adverse~     effects, and functional capacity; to explore whether description and severity of~     breathlessness are related with a clinically relevant response to morphine and to analyse~     the cost-effectiveness of morphine SR. The study population will consist of 124 clinically~     stable outpatients with COPD and severe dyspnea despite optimal pharmacological and~     non-pharmacological treatment.~   "
47978|NCT02429037|"~     The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene~     combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of~     unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and~     active-controlled study.~   "
47979|NCT02429024|"~     Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with~     patients with Type I and Type II diabetes.~   "
47980|NCT02429011|"~     The purpose of this study is to research the effects of ketamine on brain function in~     patients with Major Depressive Disorder (MDD). To study brain activity related to emotion,~     the study team will use a technology called functional MRI (fMRI), which is a method for~     evaluating the flow of blood in the brain using a powerful magnet. fMRI does not involve~     exposure to radiation.~      Patients will be shown a sample of images on a computer screen designed to bring about an~     emotional reaction. The MRI machine will then take a number of pictures of your head. By~     computer analysis, this machine is able to create a picture of your brain's activity. There~     are several tasks during scanning that involve looking at various images that represent~     different emotions, and the study team will be monitoring brain activity during these tasks.~      Patients will be scanned before and 24 hours after receiving ketamine to analyze treatments~     effects. These scans are compared to depressed patients who did not receive ketamine, as~     well as to healthy controls.~   "
47981|NCT02428998|"~     Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and~     comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce~     body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve,~     fatigue, and determine the impact on biological age.~   "
47982|NCT02428985|"~     The primary objective in this study is to collect post-marketing information on Riociguat~     safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that~     occur within the first 12 months and in the following 6 -year observation at most, after~     starting Riociguat treatment under the routine clinical practice will be collected.~      The secondary objectives are collecting information on Riociguat effectiveness, such as~     6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term~     use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be~     surveyed once a year.~   "
48039|NCT02428244|"~     It is well known that smoking has deleterious effects to fracture/broken bone outcomes.~     Complications associated with smoking can be mitigated by smoking cessation. Initiating~     smoking cessation programs while patients are in the inpatient hospital setting has shown to~     be an opportune time to enroll patients in a smoking cessation program. The goal of this~     study is to determine if inpatient smoking counseling with/without follow-up is superior to~     the standard smoking cessation information associated with admission to a hospital facility.~   "
47983|NCT02428972|"~     Primary brain tumors are highly associated with neurocognitive deficit and poor quality of~     life. There are number of studies indicating that brain tumors and their treatment~     modalities are often related to cognitive dysfunction. Apart from primary brain lesions,~     deficit can also occur because of Surgery, Radiotherapy, Chemotherapy, Antiepileptic and~     Corticosteroid treatment.Anaesthesia can also add to cognitive deficit in these patients.~     According to Ali et al. propofol provides better cognition scores compared to sevoflurane~     than isoflurane. The primary aim of their study was to compare the effects of 3 anesthetic~     regimens on hemodynamics and recovery characteristics of the patients. However in another~     study by Magni et al., the authors found that there is no difference in early cognitive~     function between sevoflurane and propofol. The aim of this prospective, randomized,~     open-label clinical trial was to compare clinical properties of sevoflurane-fentanyl with~     propofol-remifentanil anesthesia in patients undergoing supratentorial intracranial surgery.~     However both these studies evaluated the early cognitive function. The primary endpoint was~     to compare early postoperative recovery and cognitive functions within the two groups. They~     also evaluated hemodynamic events, vomiting, shivering, and pain. The literature is scarce~     on the severity, incidence and effect of anaesthetics on cognition and quality of life of~     these patients. Since most of the patients of brain tumor cannot be cured with surgery~     alone, improvement of quality of life and palliative care of the symptoms and cognitive~     function are important part of the treatment. Now the cognitive function has also been~     considered as an independent prognostic factor in the survival of patients of brain tumor.~     Cognitive function can also be related to tumor laterality. Patients with tumors in left~     hemisphere will have lower scores on verbal tests, whereas tumor in right hemisphere will~     have lower scores on facial recognition tests. Patients with tumors in the left hemisphere~     report more difficulty concentrating and those with right-hemisphere lesions,report more~     tension. Patients with primary brain tumors also experience serious challenges to their~     quality of life (QOL). These patients may face motor deficits, personality changes,~     cognitive deficits, aphasia, or visual field defects.~   "
47984|NCT02428959|"~     This research is being done to see if a study drug called amyl nitrite can be helpful with~     diagnosing different disorders affecting the lower esophageal sphincter in patients with~     dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry~     (HRM).~      Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia~     is a disorder of the esophagus, the tube that carries food from the mouth to the stomach.~     This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia~     is a secondary form of achalasia, which has very similar symptoms but is caused by different~     reasons. Because the treatments for achalasia and pseudoachalasia are different, it is~     important to correctly diagnose each condition. At this time, there is no way to distinguish~     the two with the current tests used at Johns Hopkins.~      Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential~     means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and~     Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in~     motility testing and its use in this study is considered investigational. Investigators hope~     that the results from the proposed study could have significant clinical implications for~     patient management by helping doctors distinguish between achalasia and pseudoachalasia and~     allow them to choose appropriate treatment.~      Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high~     resolution esophageal manometry (HRM) may join this study.~   "
47985|NCT02428946|"~     In this study the investigators will examine the effect of dopamine (bromocriptine) on~     insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine~     whether the timing of bromocriptine administration has influence on insulin sensitivity.~      To do so, the investigators will include lean and obese subjects who will use 2 times 2~     weeks bromocriptine. In randomized order, they will use it in the morning or in the evening.~      The investigators will examine insulin sensitivity by performing a 7-point oral glucose~     tolerance test.~      Furthermore, the investigators will examine energy expenditure and subjects will keep track~     of their eating behaviour in the 3 days before each study visit.~   "
47986|NCT02428933|"~     In this study the investigators will investigate the effect of dopamine (bromocriptine) on~     Brown Adipose Tissue in lean, young, healthy males.~      The investigators will also examine energy expenditure, body temperature and insulin~     sensitivity as measurements of Brown Adipose Tissue activity.~   "
47987|NCT02428920|"~     The Grenada Heart Project (GHP) conducted an observational study within a randomly selected~     adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical,~     biological and psychosocial determinants of the cardiovascular health in Grenada, in order~     to develop and implement a nationwide cardiovascular health promotion program.~      The sample of 2,827 adults was randomly selected from the national electronic voter list.~     The main outcome measures were self-reported cardiovascular disease and behavioral risk~     factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and~     lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity,~     hypertension and diabetes significantly exceeding those seen in the U.S.~      Since the completion of this assessment, an additional effort has contributed significantly~     to the current project. A parallel community health-promotion project was carried out in~     Cardona, Spain called the Cardona Integral Fifty-Fifty project with 80 subjects. The~     preliminary results of the Cardona study have a shown that peer motivation may significantly~     improve healthy behaviors and thus modify cardiovascular risk.~      The GHP CHANGE community -based intervention aims to promote positive behaviors and focus~     more on what creates health, rather than what prevents sickness. It is built on the~     foundations of social support, assessing whether people going through similar challenges~     will support each other, work together to identify and address barriers to success, and~     motivate each other to move forward. In this program we test for the impact of promotion of~     healthy lifestyle behaviors through peer motivation on blood pressure, physical activity,~     eating behavior, weight, and smoking.~   "
47988|NCT02428907|"~     Some patients experience a degree of pain and discomfort during endoscopic examination of~     the large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage~     or intense pain may lead to hypotension and impaired level of consciousness. The purpose of~     the present study was to determine if simulation training of endoscopy staff in preventing~     pain and handling acute complications through effective teamwork could improve the quality~     of colonoscopy from the patients' perspective.~   "
47989|NCT02428894|"~     The purpose of this study is to characterize changes in the plasma proteome over time~     following left ventricular assist device (LVAD) implantation.~   "
48009|NCT02428634|"~     The objective of the study is to evaluate the effects of Program SI! for Elementary in~     different times of exposure for childrens and their immediate environment (teachers and~     parents). For this purpose, 48 public schools from the Community of Madrid-South Area~     (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention~     group) or keep their normal curriculum (control group). The main outcome is 3-year, and~     6-year changes from baseline of questionnaire scoring of children, their parents and~     teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year~     changes of cardiovascular markers derived from blood pressure and anthropometry.~   "
47990|NCT02428881|"~     Hypothesis / aims of study~      Urinary retention is uncommon in young women, and one cause is a primary disorder of~     urethral sphincter relaxation, characterised by an elevated urethral pressure profile and~     specific findings in the urethral sphincter EMG (Fowler's Syndrome). Women may present with~     symptoms of obstructed voiding or complete urinary retention. Clean intermittent~     self-catheterisation is often painful to perform and currently, the only treatment to show~     benefit is sacral neuromodulation. This aim of this pilot study is to assess the efficacy of~     urethral sphincter injections of botulinum toxin, defined as improvement of flow rates by~     more than 50%, improvement in residual volume and scores on the IPSS questionnaire, and~     safety, in women with Fowler's Syndrome.~      Study design, materials and methods In this open label pilot institutional review board~     approved study, ten women with a primary disorder of urethral sphincter relaxation (elevated~     urethral pressure profile (UPP), sphincter volume and abnormal EMG) presenting with~     obstructed voiding (n=5) or in complete urinary retention (n=5) are recruited from a single~     tertiary referral centre. Baseline symptoms are being assessed using the IPSS questionnaire,~     and urinary flow and post-void residual volume were measured. After 2% lidocaine injection,~     100U of onabotulinumtoxintypeA is being injected into the striated urethral sphincter,~     divided on either side, under EMG guidance. Patients are being reviewed at weeks 1, 4 and 10~     post-treatment and symptoms are reassessed using the IPSS questionnaire, and urinary flow~     and post-void residual volume are being measured. The UPP is being repeated at week 4.~   "
47991|NCT02428868|"~     It is a prospective randomized controlled study aiming to test if tranexamic acid combined~     to intravenous iron before and after surgery for hip fracture in elderly can decrease~     peri-operative red cell transfusion.~   "
47992|NCT02428855|"~     This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.~   "
47993|NCT02428842|"~     Prospective Multicentric European trial for Cervical cancer, not previously treated, with~     tumour biopsies, and blood collection for molecular analysis at predetermined time points.~   "
47994|NCT02428829|"~     This study looks to examine the effect of attempting initial postoperative walking with a~     patient following a total hip replacement. Currently patients rest in bed for approximately~     24 hours following their operation before walking. The intervention group would aim to~     commence walking at between 4-6 hours after their operation.~      Outcome measures to be examined would be: length of hospital stay, patient experience of~     physiotherapy treatment, the time taken for patients to reach functional milestones and~     number of postoperative medical complications.~      The study is designed as a randomised controlled trial where participants would be separated~     randomly into two groups. One group would form the intervention group and start~     physiotherapy and attempted walking 4-6 hours after their operation. The other group would~     form the control group and would remain on the current standard rehabilitation protocol.~   "
47995|NCT02428816|"~     Based on previous promising results, the next step for the validation of a multimodal MRI~     method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to~     test whether the multimodal neuroimaging is able to discriminate at the individual level,~     patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic~     Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure~     changes over time for the two diseases, according to imaging, neuropsychological and other~     clinical data.~   "
47996|NCT02428803|"~     Home dialysis patients must be seen in a face to face visit on a monthly basis. For patients~     who live remotely these visits may impact their quality of life due to the amount of time~     needed to attend these visits. The central hypothesis is that implementation of telemedicine~     visits as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period~     will improve quality of life as judged by the quality of life (QoL) indices Kidney Disease~     Quality of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to~     QoL scales taken during a time period when the patient is on standard of care.~   "
47997|NCT02428790|"~     Empirically patients with acquired brain injury (ABI) are often constipated. This is a major~     clinical issue. Nevertheless, this has only been sparsely studied.~      The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI,~     and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in~     these patients, and associations between HRV and GITT are investigated.~   "
47998|NCT02428777|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during operative outpatient hysteroscopy. Women undergoing operative~     hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1~     hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the~     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue~     scale~   "
47999|NCT02428764|"~     The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin~     followed by surgery to see how well it works in treating patients with unresectable stage~     III squamous cell lung carcinoma.~   "
48000|NCT02428751|"~     The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone~     (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse~     large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe~     cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern~     among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with~     a prolonged circulation time and unique toxicity profile. Previous single arm studies of~     elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional~     doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone~     (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone~     marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the~     efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head~     compared in a randomized study. The aim of this study is to compare the efficacy and safety~     of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and~     prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and~     prednisone) in previously untreated elderly patients with DLBCL.~   "
48416|NCT02423330|"~     This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to~     treat anal fistulas.~   "
48001|NCT02428738|"~     Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year~     worldwide and affects people of all ages. These epidemics typically occur in the winter~     months, and can result in substantial morbidity and mortality in persons at risk. Pregnant~     women may be more susceptible to morbidity and mortality associated with influenza~     infection. This increased risk may result from several factors including increased heart~     rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in~     immunologic function. Immunization of women during pregnancy can help to prevent infection~     in the woman herself and may also offer protection to the infant in two ways: by the passage~     of antibodies from mother to the fetus during pregnancy, and by preventing infection in the~     mother and therefore decreasing the infant's exposure risk after birth. In Canada, the~     National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women~     who are expected to deliver during influenza season because they will become household~     contacts of their newborn. Ideal timing of vaccination occurs in October or November since~     influenza outbreaks typically occur throughout the winter months. Despite the Canadian and~     American guidelines for influenza vaccination during pregnancy, it is unclear how many women~     are offered and/or actually receive the vaccine while pregnant. There is, however, evidence~     that women will accept the vaccine if offered. Specifically, in the Women's Health Care~     Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also~     received the influenza vaccination when offered. Innovative techniques will be required to~     continue to increase vaccination rates among vulnerable populations, including pregnant~     women. The purpose of the present study is to determine if the use of electronic reminders~     (text messages) increases the likelihood of receiving the influenza vaccine among pregnant~     women.~   "
48002|NCT02428725|"~     This study will try to determine if the measure of the platelet reactivity of the patients~     receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary~     angioplasty allows to predict the hemorrhagic risk.~   "
48003|NCT02428712|"~     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated~     dose/recommended Phase 2 dose, and efficacy of PLX8394.~   "
48004|NCT02428699|"~     This study is designed to compare the incremental area under the curve from 0 to 24h~     (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid~     (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a~     non-emulsified reference control of free flowing cod liver oil at the lowest appropriate~     dose that is practically acceptable, and as near as possible to the test products'~     recommended daily dose.~   "
48005|NCT02428686|"~     Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic~     syndrome. It generates an increased rate of morbidity and mortality in this population of~     patients whose median age is high and the rate of co-mobidities important. The historical~     treatment is limited to transfusion support with a significant impact on quality of life and~     the incidence of secondary haemosiderosis, which contributes to the emergence of~     co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall~     erythroid response in 40-60% of patients treated.~      In this trial, the investigators intend to study the interest of a treatment with epoetin~     beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with~     IPSS score <1.~      In addition to studying the erythroid response, the investigators will measure the impact on~     quality of life and functional performance.~      Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and~     24 weeks of treatment.~   "
48006|NCT02428673|"~     Children with neuromuscular disabilities and limited ambulation are at significant risk for~     decreased bone mineral density (BMD) and increased incidence of fracture. This is caused, in~     part, by low levels of load experienced by the skeleton due to a child's functional~     limitations. Low BMD has been shown to be predictive of fracture, and in fact, fractures~     usually occur without significant trauma in children with neuromuscular conditions. The~     discomfort and distress from fractures in this population are considerable, and the~     associated costs to the family and healthcare system are substantial. Numerous interventions~     have been devoted to improving BMD in these children. Stationary assisted standing devices~     are widely used and represent the standard-of-care. However, evidence supporting this~     approach is limited due to inadequate study designs with insufficient numbers of patients.~      This study will use load-sensing platforms in patients with neuromuscular conditions.~     Successful completion of this pilot study will assist in the development of a future~     multicenter clinical trial to definitively determine relationships, if any, between passive~     standing and measures of BMD, fracture incidence, pulmonary function, and health-related~     quality-of-life measures in children with a variety of neuromuscular disabilities (e.g.,~     spinal muscular atrophy, cerebral palsy, muscular dystrophy, spina bifida, Rett syndrome).~      Hypothesis: Assisted standing treatment program will gradually increase their duration of~     standing by up to 75% after the baseline phase.~   "
48007|NCT02428660|"~     This randomized controlled trial will evaluate whether the use of pharmacogenetic testing~     through a Medication Therapy Management (MTM) program has a beneficial impact on drug~     therapy problems. More specifically, cytochrome DNA testing, which provides information with~     regards to participant specific metabolism of medications, will be used in the evaluation of~     participant medication regimens. The overall aim of the project is to evaluate if the~     addition of genetic CYP testing to a standardized MTM Program provides increased clinical~     value. To answer this question, the investigators will look at the drug therapy problems~     (DTPs) identified by the genetic test compared to those DTPs discovered without the test.~   "
48008|NCT02428647|"~     The study will be conducted as a community-based, randomized, placebo-controlled, trial with~     four study groups. The overall objective of the study is to determine the optimal method for~     delivering zinc to young children, both for the prevention of zinc deficiency and treatment~     of diarrhea. In particular, the investigators plan to compare the impact on physical growth,~     morbidity, micronutrient status, immune function, environmental enteric dysfunction,~     parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation~     as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc~     supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible~     tablets given in relation to episodes of diarrhea.~      In addition to the major outcomes mentioned above, the investigators will monitor adherence~     to the interventions, neuro-behavioral development, and the occurrence of any adverse~     events.~   "
48010|NCT02428621|"~     The aim of this prospective, multicentric, randomized, open-label study is to assess the~     efficacy of the removable Twicare® as mandibular propulsive appliance in children aged from~     7 to 12 years old in the course of their orthodontic treatment, showing its noninferiority~     with the removable Herbst. One untreated group will be included to control the internal~     validity of the study as recommend in noninferiority trials. Patients will have a follow-up~     every two months during 6 to 12 months as planned in routine care.~   "
48015|NCT02428556|"~     OBJECTIVE: To learn how people understand language used by the FDA to describe certain newly~     approved medications called breakthrough drugs.~      BACKGROUND: FDA allows drugs to be designated as breakthrough if there is preliminary~     evidence that it may offer a substantial improvement over available therapies. But consumers~     (and prescribers) may mistake the word — which in this context means very preliminary~     promise and lots of uncertainty - to mean the drug is proven to be much more effective or~     much safer than existing drugs.~      METHODS: Internet survey (with colleagues from Carnegie Mellon University) using Amazon~     Mechanical Turk - a web tool that recruits people willing to do surveys~     (https://www.mturk.com/mturk/welcome). Participants will be asked to read a short scenario~     about a new drug (facts are based on a real drug but the investigators use a fictional name)~     and answer questions about how well they think the drug works, how safe it is, etc. People~     will be randomized to one of 5 versions of the scenario differing in how explicitly they~     explain what breakthrough means. The information in the scenario is drawn from FDA's own~     press release about the drug.~   "
48016|NCT02428543|"~     This project is part of a joint ALFA and GOELAM strategy aiming to improve the survival of~     patients with newly diagnosed Acute Myeloid Leukemia (AML) aged 18-70 years. The basis of~     this strategy is to evaluate intensified conventional chemotherapy and targeted drugs in~     selected disease-risk subgroups of adult patients with non promyelocytic AML. Participation~     will be proposed to almost all adult patients in France aged 18-70 years and diagnosed with~     AML.~      FLT3 genetic alterations include FLT3 somatic point mutations within the second tyrosine~     kinase domain and internal duplications of the juxta-membrane domain. This alteration is~     refered to as FLT3-ITD. The FLT3-ITD mutation is found in around 30% of patients with~     cytogenetically normal AML. Patients with the FLT3-ITD genotype have been reported to have a~     poor outcome when treated with conventional chemotherapy with an estimated 4-year~     relapse-free survival of 25% (Schlenk et al. N Engl J Med 2008). More recently, the~     prognostic relevance of FLT3-ITD has been studied in the context of integrated genetic~     profiling. This confirmed the genetic complexity of AML and also that FLT3-ITD was~     associated with reduced overall survival in intermediate-risk AML. A multivariate analysis~     of several genetic alterations revealed that FLT3-ITD was the primary predictor of patient~     outcome. FLT3-ITD mutations were classified in 3 categories: 1) FLT3-ITD with +8, TET2,~     DNMT3A or MLL-PTD mutations (3-year OS 14.5%); 2) FLT3-ITD with wild type CEBPA, TET2, DNMT3~     and MLL-PTD (3-year OS 35.2%) and 3) FLT3-ITD with CEBPA mutations (3-year OS 42%) (Patel JP~     et al. N Engl J Med 2012). However, FLT3-ITD was not a predictor of response to induction~     therapy, allowing the introduction of targeted therapies after the induction course.~      Several FLT3 inhibitors have been evaluated or are currently being tested in the setting of~     relapsing AML. In most trials to date, patients were only eligible if the FLT3-ITD mutation~     was present. Disappointing results were reported with the first generation of FLT3~     inhibitors, including lestaurtinib (CEP-701), midostaurin (PKC-412) and sorafenib. Second~     generation FLT3 inhibitors such as quizartinib (AC220) are currently under investigation~     with promising results. However, the hematologic toxicity of AC220 will likely present a~     major limitation in evaluating AC220 combined with standard or high-dose chemotherapy.~      Ponatinib (AP24534) is a third generation tyrosine kinase inhibitor targeting the BCR-ABL~     tyrosine kinase domain. Ponatinib was rationally designed with an extensive network of~     optimized molecular contacts and triple bonds to accommodate the T315I mutation, a major~     cause of resistance to tyrosine kinase inhibitors in chronic and advanced phase chronic~     myelogenous leukemia (CML). Ponatinib also inhibits SRC (IC50: 5.4 nM) and members of the~     VEGFR, FGFR, and PDGFR families of receptor tyrosine kinases (O'Hare T, Cancer Cell 2009).~     Despite low activity against FLT3 based on the IC50 value (FLT3 IC50: 12.6 nM compared to~     BCR IC50: 0.37 nM), ponatinib has recently been reported to have significant cellular~     activity against the MV4-11 cell line which harbors an FLT3-ITD activating mutation.~     Ponatinib-induced apoptosis was maximal at 10 nM in vitro and a single dose of 5 and 10~     mg/kg had a strong inhibitory effect in vivo in mice bearing MV4-11 xenografts. Primary~     blast cells from 4 FLT3-ITD AML patients were also tested and ponatinib reduced their~     viability (IC50: 4 nM) whereas no activity was shown on FLT3-ITD-negative blast cells~     (Gozgit JM et al. Mol Cancer Ther 2011).~      Preliminary data from the phase I clinical trial showed that 15 mg ponatinib was associated~     with a Cmax of 51.1 nM. Cmax was increased to 111 nM and 149 nM in the 30 mg and 45 mg~     cohorts respectively. The trough concentrations were 55.3 nM and 61.9 nM for the 30 mg and~     45 mg doses respectively (Ariad clinical investigator's brochure, version 3). Results from~     the ongoing phase II trial in CML patients suggest that the hematological toxicity profile~     of ponatinib is comparable with that of nilotinib or dasatinib, both of which have been~     successfully combined with conventional chemotherapy.~      Investigators thus aim to combine ponatinib with cytarabine in FLT3-ITD AML patients in~     first complete remission.~   "
48017|NCT02428530|"~     This study assessed the relationship between pregnant women, partner support, and cigarette~     and alcohol use in pregnancy.~   "
48018|NCT02428517|"~     This study is a prospective multicenter observational study to evaluate the feasibility and~     the efficacy of the conditioning regimens which are modified by the donor differences and~     the age of recipients among patients who will receive allogeneic hematopoietic stem cell~     transplantation in their 1st or 2nd hematologic complete remission (CR).~   "
48019|NCT02428504|"~     It is not universal that terminally ill patients choose surrogate in the event of~     disagreement between the treating physician and the surrogate at the end of their lives.~     There are several factors that influence the terminally ill patient's decision to choose a~     decision maker at the end of his / life.~   "
48020|NCT02428491|"~     The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's~     DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2,~     3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a~     dose of Hep B vaccine at birth or within 1 week after birth.~      Primary Objective:~        -  To describe the safety profile after each and all doses of Sanofi-Pasteur's~          DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers~      Secondary Objective:~        -  To evaluate the immunogenicity of the study vaccine one month after the third dose~          primary series.~        -  To demonstrate the non-inferiority of the immune response to all antigens induced by~          the study vaccine in Vietnamese infants one month after the third dose in a 3 dose~          primary series with the immune response to all antigens induced by the same study~          vaccine outside Vietnam~        -  To describe the persistence of all antibodies before receipt of the booster~          vaccination.~   "
48021|NCT02428478|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator~     muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA~     compared to normal subjects. Until recently, the search for medicines to activate pharyngeal~     muscles in sleeping humans has been discouraging. However, exciting new animal research has~     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic~     effects) on genioglossus muscle activity (EMG GG) during sleep in healthy control subjects.~   "
48022|NCT02428465|"~     Pediatricians' provision of parenting-focused anticipatory guidance often does not meet~     parents' needs; the few studies that have investigated primary-care based strategies to~     promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting~     their generalizability. Therefore, the Purposeful Parenting was developed as a universal~     program of enhanced anticipatory guidance. At each well-child visit in the first year of a~     child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance~     and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills,~     brain development and the importance of responsive parenting; and 2) a reminder item~     (e.g., a Smile at Me onesie) that allows for in-office role modeling and promotes~     practicing of an age-specific, nurturing parent-child interaction. If an in-office~     intervention is missed (e.g. parent cancels visit, interventionist out sick) the~     intervention will be delivered by telephone if possible by the site-based clinical~     interventionists and the reminder items will be mailed.~   "
48023|NCT02428452|"~     The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or~     suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about~     core, early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment~     (PRT) and associated parent training programs for enhancing development in children with~     ASD. Completion of a comprehensive pilot study set the stage for a randomized control trial~     (RCT) of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social~     ABCs intervention program on improving spoken language skills and positive parent-child~     emotion sharing in toddlers with signs of or a diagnosis of ASD.~   "
48024|NCT02428439|"~     The objective of this study is to identification of genetic markers and predictors of~     antidepressant-induced suicidality in youth depression. Participants who take the~     standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for~     8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4)~     and visit 4 (week 8)~   "
48025|NCT02428426|"~     To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal~     tissue.~   "
48026|NCT02428413|"~     The purpose of this study is to evaluate anesthetic gas in the PACU within patient and~     caregiver breathing zones.~   "
48027|NCT02428400|"~     Methodology:~      This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in~     patients that are currently being treated for chronic HBV infection. For all cohorts,~     patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate~     (TDF) or entecavir (ENT) for at least two years, and have their HBV infection~     well-controlled~   "
48430|NCT02423148|"~     This research study is studying a new imaging method that will show lymph nodes in the lung~     during lung cancer surgery. The name of the study intervention involved in this study is:~      -- The combination of the FluoSCOPE device and Indocyanine Green~   "
48028|NCT02428387|"~     With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing,~     supporting family care partners of persons with ADRD is critical. Family caregivers provide~     about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due~     to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and~     multiple chronic conditions (MCC) experience significant, complex, distressing transitions~     such as changes to their environment, roles and relationships, physical and mental health,~     isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was~     developed for family caregivers of persons with ADRD and MCC living at home, to support~     caregivers through transitions and increase their self-efficacy, hope, and quality of life~     (QOL).~      Through this pragmatic mixed methods randomized controlled trial the investigators expect to~     find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater~     improvement in hope, self-efficacy and QOL, at no additional cost from a societal~     perspective, compared with those in an educational control group. Following baseline data~     collection 180 participants will be randomly assigned to one of the groups with repeated~     measures at one, three and six months.~   "
48029|NCT02428374|"~     The fascinating role of lymphocyte subtypes in the development of coronary artery disease~     may be a new strategic target for understanding and therapy of acute myocardial infarction.~     The determinants of cell viability are unknown, postulating that they arise from factors not~     only related to microcirculation or energy expenditure, but also to inflammatory and immune~     responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial~     infarction triggers large lymphocyte proliferation that colonizes plaques in development,~     contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and~     metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary~     disease progression.~   "
48030|NCT02428361|"~     This is a prospective, open label pilot study in which patients with symptoms of acute or~     chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators~     hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims~     our:~        1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial~          Transplantation.~        2. To determine if endoscopic appearance of ileal pouch improves following treatment by~          Fecal Microbial Transplantation.~   "
48031|NCT02428348|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate~     clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so~     that hospital admission in the EMU can be avoided for some patients and an increasing number~     of patients can be examined.~      Phase 3 of this Project will be divided into Phase 3a and Phase 3b.~      In Phase 3b of the project epilepsy patients and their family will be interviewed about~     different EEG-cap models in development. This interview is anticipated to take approximately~     1 hour.~      Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.~      The results of the interviews will be analysed by the design company pilipili nv.~   "
48032|NCT02428335|"~     Sunitinib is a chemotherapy approved by the FDA as a standard of care treatment for renal~     cell carcinoma (RCC). Fatigue is a very common side effect of sunitinib that frequently~     causes dose reductions. The cause of this fatigue remains unclear. This study will use a~     special type of scan to study sunitinib-induced fatigue in relation to exercise.~   "
48033|NCT02428322|"~     Epidemiological and observational studies have linked vitamin D deficiency with increased~     asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with~     increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated~     with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and~     lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D~     and allergy and asthma appears to be stronger in children than adults, with some even~     suggesting that childhood asthma may may be caused by VDD.~   "
48034|NCT02428309|"~     The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and~     effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of~     their lupus. Targeting cutaneous disease offers the ability to control background therapy,~     readily detect clinical effects, and perform research analyses not only in blood but also~     skin. Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to~     support dose selection for a future larger efficacy trial in lupus.~   "
48035|NCT02428296|"~     Background:~      - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This~     gene makes a protein that communicates with other proteins in the body to cause cells to~     grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in~     fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one~     of the proteins in this chemical signaling pathway. Researchers want to learn whether the~     drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS~     experience.~      Objectives:~      - To measure how the overgrowth of patients with PROS changes over time and whether taking a~     drug called sirolimus can reduce or stabilize a person s overgrowth.~      Eligibility:~      - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene~     in the person s affected tissues (a somatic mutation).~      Design:~        -  Participants will be screened with medical history and genetic counseling.~        -  First 6 months: Participants will have their overgrowth monitored.~        -  Next 6 months: Participants will take sirolimus once or twice a day.~        -  Participants will have to visit the clinic several times, and stay in the area for 4 5~          days each time.~        -  Participants will have a one month-long visit to the clinic.~        -  During clinic visits, participants will have:~        -  Blood and urine tests.~        -  Photographs of their physical features.~        -  Scans, including an MRI and DEXA, and possibly x-rays and CT scans.~        -  For the MRI and CT scans, participants will lie in a machine that takes pictures of~          their body.~        -  The DEXA involves a small amount of radiation.~        -  They may have:~        -  Non-invasive heart function tests.~        -  Lung function tests.~        -  Participants will have several blood and urine tests between visits.~        -  Participants will complete surveys and keep a diary of their treatment and side~          effects.~        -  Participants may visit other health specialists or undergo other tests based on side~          effects.~        -  One month after stopping the study drug, participants will have 1 clinic visit.~   "
48036|NCT02428283|"~     Emergence agitation is a common problem in children during recovery from sevoflurane~     anesthesia. Pain is considered as a cause of postoperative emergence agitation and~     compounding factor of agitation assessment in children. The purpose of this study was to~     investigate the effect of scalp nerve block on the emergence agitation in children~     undergoing nevus surgery during sevoflurane anesthesia.~   "
48037|NCT02428270|"~     This is a phase 2 study (the second phase in testing a new drug or combination to see how~     effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.~      The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib~     in patients with advanced pancreatic cancer.~   "
48040|NCT02428231|"~     The primary objective of the study is to assess whether a 6-week titration (compared with a~     1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF)-related~     gastrointestinal (GI) Adverse Events (AEs) in subjects with Multiple Sclerosis (MS). The~     secondary objective of this study is to assess whether a 6-week titration (compared with a~     1-week titration) is effective in reducing the average severity and duration of GI symptoms~     over 12 weeks of dimethyl fumarate treatment in this study population.~   "
48041|NCT02428218|"~     The primary objective of the study is to assess the efficacy of oral BG00012 as compared~     with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The~     secondary objectives of this study are to evaluate the safety and tolerability of BG00012~     and to compare the effect of BG00012 with placebo on additional clinical and radiological~     measures of disease activity.~   "
48042|NCT02428205|"~     The purpose of this study is to explore the effects of propranolol in combination with early~     intensive behavioral intervention on social interaction, and secondarily on language,~     anxiety, adaptive behaviors, and global function in children with autism in a~     double-blinded, placebo-controlled pilot trial.~   "
48043|NCT02428192|"~     This phase II trial studies how well nivolumab works in treating patients with uterine~     cancer that has spread to other places in the body and usually cannot be cured or controlled~     with treatment. Monoclonal antibodies, such as nivolumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
48044|NCT02428179|"~     Surgical site infection (SSI) is the most frequent complication in patients that undergo~     abdominal surgery. A previous prospective observational study in 167 patients undergoing~     elective open abdominal procedures showed that case-relevant communication protects from~     organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the~     procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical~     applicable intervention structured briefing using the StOP protocol has been developed and~     was tested in pilot experiments. This intervention aims at improving case-relevant~     communication during the procedure and to reduce excess case-irrelevant communication at the~     end of an operation.~      The hypothesis is: structured briefings during an operation reduce the incidence of SSI~     after surgery.~   "
48045|NCT02428166|"~     The purpose of this retrospective study is to assess corneal changes (keratometry,~     pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral~     crosslinking treatment compared to the untreated fellow eye. The corneal measurements~     obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating~     scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and~     ocular surgeries as potential factors involved in treatment outcome are also evaluated.~   "
48046|NCT02428153|"~     The purpose of this study is to investigate the acute effects of two different types of~     muscle stretching (static and dynamic) on muscle-tendon unit of gastrocnemius muscle by~     ultrasound and to follow how long the stretching effects are sustained.~   "
48047|NCT02428140|"~     The overall aim of this trial is to determine the most cost effective approach to diagnose~     paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.~      A summary of the rationale for this study is as follows:~        1. Recently completed randomized trials of cardiac monitoring following stroke have~          established that PAF is more common than previously recognized in cryptogenic stroke.~        2. The majority of TIA/stroke patients will have at least one potential stroke mechanism~          identified by the time etiologic investigations completed.~        3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel~          atherosclerosis) is clinically important since appropriate anticoagulation for AF~          reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic~          strokes.~        4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no~          cost effectiveness data~        5. The rates of PAF in strokes with known causes (SKC) have not been well characterized.~      PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first~     line investigations to detect PAF in patients with recent stroke and TIA. The study will~     also assess whether a pivotal trial is feasible and warranted.~      The principal research questions to be addressed in this study will be:~        1. What is the relative cost-effectiveness as a first line investigation of long-term~          implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external~          event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically~          actionable AF in following TIA/stroke.~        2. What is the feasibility, patient compliance, diagnostic accuracy and rates of AF~          detection (>30 seconds) of ILR compared to the ELR strategies.~   "
48048|NCT02428127|"~     The purpose of this study is to investigate the impact of a beverage containing carbohydrate~     powder fortified with micronutrients on agility, speed, and power in school going children~   "
48049|NCT02428114|"~     In patients with early-stage breast cancer, chemotherapy has substantially improved survival~     rates for breast cancer patients. Improvements in outcomes, however, are compromised by the~     considerable toxicities associated with chemotherapy, most notable being neutropenia.~     Neutropenia is the presence of abnormally few white blood cells, leading to increased~     susceptibility to infection and can require hospitalization and need for intravenous~     antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with~     treatment delays and dose reductions, potentially compromising treatment efficacy. Patients~     can receive medication to reduce the risk of febrile neutropenia, such as Neupogen~     (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty~     amongst healthcare professionals as to which administration schedule of Neupogen is better,~     investigators are performing a randomized study in which patients are put into a group by~     chance to give participants one of three standards of Neupogen daily injection. Neupogen can~     cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of~     treatment this can cost $16,000 compared to a 5 day prescription which would cost half this.~     In addition to cost savings, many patients are not able to give themselves injections on a~     daily basis and require nursing resources which are utilized at high-cost. This study will~     use an integrated consent model that involves an oral consent rather than a written~     informed consenting process in order to increase the number of patients who may participate~     while performing a study at a lower cost. While determining the optimal treatment will~     improve patient comfort and acceptability, using the minimal safe duration of administration~     may also offer cost savings.~   "
48050|NCT02428101|"~     This study will examine DNA from Gastrointestinal Tract of cancer patients treated with~     oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to~     drug-induced peripheral neuropathy in certain patients.~      The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2~     gene(G34A ,C421A genotypes) and correlated with peripheral neuropathy grades.~   "
48051|NCT02428088|"~     This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with~     ADHD.~   "
48052|NCT02428075|"~     Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and~     middle-income countries; however responses to CVDs are inadequate particularly due to lack~     of conclusive evidence on population based approach to hypertension control. This is a~     community based cluster randomized trial involving family based health education through~     female community health volunteers in Nepal. People ≥25 years of age and who are listed in~     the voter list 2006 of Electoral Commission of Nepal who were either hypertensive,~     pre-hypertensive or normotensive are eligible for eligible for participation in the study. A~     computer generated random codes will be used to divide clusters into treatment and control~     arm. FCHVs will conduct family based health education and blood pressure measurements in the~     treatment arm vs not any interventions in control arm. Independent assessors will conduct~     the baseline and end line assessment of the intervention. Intention to treat analysis and~     per protocol analysis will be used in analysis to detect significant differences between~     treatment and control group participants at baseline and follow up. Student t-tests for~     normally distributed variables and chi-squared tests for categorical variables will be used.~     In the event that randomization do not control for differences between the treatment and~     control groups on baseline characteristics, the investigators will statistically control for~     those differences in subsequent analysis of program effects. The final outcome will be~     modeled by using multiple linear regressions analysis. The investigators hope that if the~     intervention outcomes shows positive effects in treatment arm, this approach can be adopted~     into the existing health care delivery system in Nepal. Assessing the FCHVs' ability may~     further contribute to developing a policy that can be scaled-up to a national level. The~     lessons learned from this project may also be replicated in rural areas and similar settings~     elsewhere in the world.~   "
48053|NCT02428062|"~     BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss~     of brain functions observed in elderly patients after surgical operations under general~     anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70~     years and more, and the only recognized risk factor for this condition is increasing age.~     Importantly, the incidence of POCD at 3 months has been associated to an increased~     disability and mortality.~      OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing~     general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at~     maintaining intra-operative arterial blood pressure close to patient's preoperative blood~     pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three~     months.~      METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for~     elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be~     evaluated preoperatively and at 3 months and 1 year postoperatively, together with the~     occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of~     postoperative delirium and cardiovascular, respiratory and infectious complications will be~     evaluated.~      EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD~     at 3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1~     postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3~     months, a reduction in the incidence of delirium. Hospital length of stay and 90 day~     mortality will also be assessed. This present study could have a high socio-economic impact,~     reduce healthcare costs and patient morbidity and mortality with a simple not expensive~     intraoperative intervention.~   "
48054|NCT02428049|"~     The investigators want to:~        1. Assess whether curative radiotherapy for lung cancer leads to permanently reduced lung~          function~        2. To assess the predictive value of pulmonary function tests for the development of a~          permanent reduction in lung function after curative radiotherapy~        3. To assess the predictive value of genetic markers for permanently reduced lung function~          after curative radiotherapy~   "
48055|NCT02428036|"~     The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated~     mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of~     solid tumors with superficial lesions.~   "
48056|NCT02428023|"~     Our purpose is to investigate whether thallasaemia trait offers protection against~     cardiovascular events and whether this can be applied to specific characteristics of these~     people ( better lipid profile , better blood pressure profile) as scientific literature~     suggests.~   "
48057|NCT02428010|"~     Study to evaluate the safety and performance of the Twelve TMVR System~   "
48058|NCT02427997|"~     A prospective, randomized controlled single-blind trial will test the hypotheses that a 6-~     week intervention that combines treadmill training (TT) with virtual reality (VR)~     significantly improves real-life, functional mobility and cognitive abilities, keys to~     health-related quality of life in patients with MS.~   "
48059|NCT02427984|"~     During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been~     implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately~     60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is~     very good, as widely demonstrated in the literature. On the basis of data produced by the~     only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic~     Implants in the Region Emilia-Romagna) survival rate of primary total hip prosthesis is~     95.6% at 9 years. Reasons for revision are mainly aseptic loosening of one or both~     components (40% of the total) and dislocation (26%), being the latter much more frequent in~     the first two years. Less frequently revision is due to sepsis (7% of the total),bone~     fracture (11%), prosthesis fracture (3%) or pain (3%). Revision is relates, among the~     others, to prosthesis-related factors, such as fixation to bone and articular coupling. In~     our experience, during the last ten years 32% of implants had both articular component in~     ceramic , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both~     components in metal.~      Each solution has strengths and weakness and they have been identified and clinically~     applied in order to overcome step by step limitations observed in the previous one. The most~     recent are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These~     two solutions, beside very promising results on wear resistance, show some peculiar~     failures: respectively fracture of the ceramic component and hypersensitivity induced by~     metal ions.~      Aim of research proposal is to investigate two uncommon and less investigated early symptoms~     of failure:~        -  'noising hip' in ceramic on ceramic total hip arthroplasty~        -  pain without radiographic signs of loosening in metal on metal total hip arthroplasty~          These two situations are extremely relevant, as they prelude to a failure of the~          prosthesis. If clearly identified they could represent a powerful tool in early~          diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total~          hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic~          procedure.~      The first group will be studied through CT scan of the patients to evaluate impingement or~     instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be~     examined to identify ceramic wear debris, according to a method of separation and analysis~     in scanning electron microscopy that was set in our Lab.~      Sound will be recorded by means of a wearable sensor set capable of recording the articular~     noise produced during level walking. This instrumentation will be coupled to motion analysis~     technology.~      This would make possible a diagnostic approach able to correlate the involved factors to~     clinical occurrences, on the basis of the recorded frequencies.~      -Second group will be studied through the dosage of circulating ions, deriving from the~     articular surfaces and through the histological classification of vasculitis in periimplant~     tissues. There is increasing evidence, indeed that locale release of submicron particles~     worn out from articular surfaces can release metal ions (mainly Chromium and Cobalt)~     responsible for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and~     CD3 positive T lymphocyte and sometimes CD68 positive plasma cells are present. The cells~     could justify the development of pseudotumors in metal-on metal hip prosthesis.~      Data collected from patients matched to in vitro results will allow us to to avoid or at~     least propose a more appropriate timing for revision surgery.~   "
48060|NCT02427971|"~     The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic~     concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the~     maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.~      The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and~     end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered~     fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it~     possible to maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a~     steady Fe curve.~      The goal of this work was to compare the maniability of the intraoperative administered~     concentrations and the consumption of Desflurane between these 2 modalities of~     administration.~   "
48061|NCT02427958|"~     The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the~     treatment of Central Precocious Puberty (CPP).~   "
48062|NCT02427945|"~     The investigators are seeking to overcome the dual challenges of under-nutrition and~     diarrhea using an existing safe water supply platform to deliver nutrition information to~     targeted groups in Western Kenya. Using a randomized evaluation, investigators will~     determine the impact on nutrition status and practices of delivering nutrition information.~     The evaluation results will enable Evidence Action to make strategic decisions regarding the~     potential scale-up of the combined program across Kenya.~   "
48063|NCT02427932|"~     This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women~     to that of non-pregnant women; the placental transfer over time; and the subsequent~     metabolism of the transferred drug(s) in the neonate.~   "
48071|NCT02427828|"~     Failure to recognise deterioration early is a major cause of preventable deaths amongst~     hospital patients. The investigators wish to study whether continuous monitoring of 'vital~     signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled~     alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care~     readmissions from the wards by alerting staff to clinical deteriorations more effectively~     than current paperbased systems.~      Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of~     'vital signs' has traditionally been restricted to the bedside because of the need for the~     patient to be connected by wires to the monitor.~      More recently, advances in telemetry (wireless technology) have allowed the development of~     wearable devices which allow patients to mobilise freely, whilst constantly monitoring these~     'vital signs'.~   "
48106|NCT02427373|"~     A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in~     which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d~     eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish~     oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to~     compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at~     the end of the 4 week study.~   "
48064|NCT02427919|"~     Granulocyte Colony Stimulating Factor (G-CSF, filgrastim) is now widely used after~     chemotherapy which complicates hematological toxicity involving neutropenia. As prolonged~     neutropenia leads to neutropenic fever due to bacteremia or fungal infection, the use of~     G-CSF prevents severe infectious complication in various cancer patients.~      In acute myeloid leukemia (AML), leukemic blasts have been expected to have G-CSF receptor~     which may be stimulated by G-CSF, and refractory patients were not treated with G-CSF in~     salvage chemotherapy in Catholic blood and marrow transplantation (BMT) Center for a long~     time. This strategy induced prolonged neutropenia and a lot of infectious complications some~     of which led to deaths.~      Although there are some data which remind us G-CSF may proliferate leukemic blasts, the~     investigators also identified several reports which suggested that subgroup with G-CSF use~     showed acceptable CR rate and improved survival outcomes compared to a subgroup without~     G-CSF use.~      Therefore investigators are now trying to identify the effects of G-CSF for refractory AML~     patients in salvage chemotherapy setting regarding the duration of neutropenia and~     admission, incidence of infectious complications and the duration of antibiotics~     application. Furthermore, overall response rate (CR+CRi) after salvage chemotherapy and~     survival outcomes will be calculated according to G-CSF use.~      Also, investigators will detect G-CSF receptor using cluster of differentiation 114 (CD114),~     and analyze the clinical outcomes according to the subgroups with or without using G-CSF~     during neutropenic period.~   "
48065|NCT02427906|"~     The purpose of this study is to determine the effect of transjugular intrahepatic~     portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic~     patients.~   "
48066|NCT02427893|"~     This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib~     (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF~     V600E/K mutant melanoma.~   "
48067|NCT02427880|"~     The purpose of this study is to determine whether using furosemide following acetazolamide~     is effective in treating refractory edema associated with nephrotic syndrome.~   "
48068|NCT02427867|"~     Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in~     cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.~      Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote~     organ or vascular territory provides protection from injury by myocardial ischemia and~     reperfusion. In the translation of remote ischemic preconditioning from bench to bedside,~     the first proof of principle and small randomized controlled trials have shown a decreased~     release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary~     artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into~     better survival in a recent randomized trial performed in cardiac surgery. No clinical trial~     on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.~      The investigators study wants to test, for the first time, the hypothesis that remote~     ischaemic preconditioning is effective in reducing cardiac damage in high risk patients~     undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by~     inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by~     5 minutes reperfusion while the cuff will be deflated. Cardiac troponin will be used as~     marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin~     release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac~     surgery setting, the investigators could improve a strategy to prevent perioperative cardiac~     complication easy to apply, safe and low cost.~   "
48069|NCT02427854|"~     In this study the investigators want to assess complications associated to pregnancy and~     delivery, and interventions used during labor.~      Pregnancy and delivery related complications are a major health problem globally. Events~     during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other~     instrumental deliveries and anesthesia problems are situations that potentially may lead to~     severe outcomes for the mother and child.~      Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and~     delivery.~      Between 60-80% of women delivering their first baby need suturing due to perineal tears~     (tears located to the area between the vagina and anus). Superficial perineal tears rarely~     cause long-term problems, but often lead to pain and discomfort immediately after birth.~     Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's~     quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction,~     and the fact that obstetric anal sphincter tear is the main cause of anal incontinence.~     Recent clinical intervention studies have shown that the incidence of severe obstetric~     perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the~     perineum. In these studies all midwives and gynecologists were trained in the bimanual~     support technique. When it comes to training in new medical techniques in general, some~     studies have shown that use of animated instructions on mobile phones may be a good~     alternative to the more traditional hands-on or bedside teaching methods. In a global~     perspective, it is important to study the efficacy of mobile units for transferring of new~     knowledge, especially for use in resource constrained settings.~   "
48070|NCT02427841|"~     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation~     and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating~     patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy,~     such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving paclitaxel~     albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and radiation~     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
48081|NCT02427698|"~     This is a prospective randomized controlled study comparing the efficacy of cryolipolysis~     versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite.~     The treatment sites are both outer thighs. One outer thigh will be randomized to receive one~     treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the~     combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist~     will evaluate the treatment and control areas using a cellulite severity scale at week 0~     (before treatment) and at the 3-month follow up visit.~   "
48072|NCT02427815|"~     Reducing sleep health disparities was recognized as a priority area for intervention by the~     National Institutes of Health. Sleep apnea, which disproportionately affects minorities, is~     an important preventable and treatable disease that should be targeted as it is associated~     with increased cardiovascular risk and disease outcomes, including obesity, diabetes,~     hypertension, stroke, cardiac arrhythmia, and chronic heart failure. Evidence from previous~     research suggests that most minorities are unaware of general sleep problems, such as sleep~     apnea symptoms and the negative effects on cardiovascular disease. Only 26% of minorities~     participating in the investigators prior research followed up on recommended sleep apnea~     screening, although 39% were at high risk for sleep apnea. While few followed the~     physician's recommendations, 90% of those assessed received a sleep apnea diagnosis. The~     investigators research will assess the effectiveness of peer-based sleep health education~     and social support in increasing sleep apnea screening and treatment rates among minorities~     with sleep apnea risk. Participants will receive quality-controlled and culturally tailored~     peer education using a sleep health education manual. They will each receive up to 4~     sessions promoting sleep apnea screening during a 6-month period. Those with a diagnosis~     will receive 2 additional sessions promoting sleep apnea treatment adherence, in conjunction~     with telephone interventions. The investigators research will also assess the rate of sleep~     apnea among minorities using home recordings. The long-term goal of the investigators study~     is to apply this intervention in community-based settings (barbershops, beauty salons,~     churches, and health centers), thereby linking community health promotion to the healthcare~     system.~   "
48073|NCT02427802|"~     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3~     parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be~     randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard~     ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application~     of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1.~      Patients will be treated for approximately 28 days and return to the clinic weekly for~     safety and efficacy assessments. After completing treatment, patients will return to the~     clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment~     is stopped.~   "
48074|NCT02427789|"~     Depression is a disorder that causes major harm to physical health and social life. It~     induces isolation, reduced physical and work capacity and increasing the risk of death. In~     contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive~     functions, stimulation of brain plasticity and resilience, in addition to promoting~     self-esteem and social interaction. The precise mechanisms by which exercise improves~     symptoms of depression are not fully clear, but it is probably multifactorial. In this~     project, the investigators aim to investigate variables that provide additional information~     about biomarkers involved in the pathophysiology of depression and therapeutic response to~     exercise. The investigators expect to find changes in biomarkers associated with potential~     mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived~     neurotrophic factor (BDNF), cortisol) after exercise program and the role in the~     therapeutics of depression. To evaluate functional assessment indices will be used~     ergospirometry, a test that determines the respiratory, cardiovascular and metabolic~     activity. Overall, this project will help to investigate alternative adjunctive treatments~     for depression and their associated biomarkers with response.~   "
48075|NCT02427776|"~     The purpose of this study is to assess the safety and the preliminary efficacy of a single~     infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple~     Sclerosis.~      The study duration for the patients (from start of baseline to end of follow-up) is 270~     days.~   "
48076|NCT02427763|"~     Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly~     invisible, removable aligners. However, every device used in the mouth can change the buccal~     flora and increase the number of bacterias. This is a risk factor for enamel~     demineralization. The treatment can vary in time of use per day. The patient under~     orthodontic treatment has to use the device for 22 hour each day. When the period of~     retention comes, it is reduced to 8 hours. The investigators want to know if the~     concentration of bacterias in saliva and dental plaque will increase, and if the material~     can cause damage on gingiva.~   "
48077|NCT02427750|"~     The present study is designed to evaluate the safety and immunogenicity of trivalent,~     surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61~     years.~      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will~     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI)~     at approximately 21 days post vaccination.~      The vaccine composition will be based on the WHO recommended influenza strains for the 2015~     Southern Hemisphere vaccine, and the data from this study are intended to support the use of~     this vaccine in future influenza seasons if the recommended vaccine composition remains the~     same.~   "
48078|NCT02427737|"~     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of~     claustrophobia or inability to hold still. Training staffs working in MRI facilities to~     provide Comfort Talk® will enable patients to complete high quality imaging without~     medication, which will increase satisfaction and comfort while reducing sedation risks for~     patients, and increase efficiency and reduce loss of revenue for facilities. The effect of~     such training will be tested at 12 MRI sites in a randomized design. Outcome data will be~     collected for one year.~   "
48079|NCT02427724|"~     This study will conduct a split-face and -body randomized control trial to compare lidocaine~     2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical~     anesthetic (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched~     532nm laser for the treatment of lentigines and/or photorejuvenation.Subjects will fill out~     a pain score on a visual analog scale (VAS) with 0 being no pain and 10 being most pain~     after each treatment area is completed.~   "
48080|NCT02427711|"~     To investigate if the use of a bipolar sealer for skin and capsula incision results in~     decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.~   "
48082|NCT02427685|"~     The study verifies accuracy of a new pulse co-oximeter in the presence of elevated~     carboxyhemoglobin levels.~   "
48145|NCT02426866|"~     The purpose of this study is to determine whether there is an increased risk of~     cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in~     patients with HIV.~   "
48083|NCT02427672|"~     This study investigates the effect of upregulating prefrontal cortex activity on antisocial~     and aggressive behavior and risk factors for such behavior. In the double-blind, randomized~     controlled trial, participants will undergo anodal transcranial direct current stimulation~     bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after~     stimulation, they will complete survey and laboratory measures assessing antisocial and~     aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and~     skin conductance will also be measured.~   "
48084|NCT02427659|"~     Using virtual reality as a form of distraction for pain during wound care. Virtual reality~     involves looking into a set of goggles and then moving through a computer-simulated world.~   "
48085|NCT02427646|"~     The present study attempts to fill a critical knowledge gap of BoNT A in tremor management~     by studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in~     essential tremor and idiopathic Parkinson disease using data regarding composition of tremor~     obtained through sophisticated, yet clinically accessible multi-sensor based kinematic~     information.~   "
48086|NCT02427633|"~     In resource limited settings, access to one-on-one nursing care and airway protection by~     intubation may be unavailable. Patients with coma but adequate oxygenation are frequently~     cared for on medical wards, and nursed by their family members. The investigators previously~     audited the use of the recovery position in patients with cerebral malaria and found that~     its usage was greatly increased by an educational intervention aimed at patient's~     caregivers. A trend to reduction in coma duration and aspiration pneumonia was also found.~     Since there is no evidence that placing comatose, non-intubated patients in a recovery~     position improves outcome, the investigators plan to conduct a randomised controlled study~     comparing standard care with an educational intervention targeting patients' relatives,~     teaching them to maintain their relative in one of two different recovery positions. With~     the preliminary efficacy and safety data and feedback that this study will provide, the~     investigators would then move to conduct a large multicenter study powered to detect a~     difference in mortality.~   "
48087|NCT02427620|"~     The goal of this clinical research study is to learn if a combination of ibrutinib and~     rituximab plus the combination of 2 different intensive chemotherapy regimens can help to~     control MCL. The safety of this drug combination will also be studied.~   "
48088|NCT02427607|"~     To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in~     participants with epilepsy. This study will be continued until perampanel is commercially~     available.~   "
48089|NCT02427594|"~     The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure~     and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary~     supplement similar to baking soda. This may be important for patients with kidney disease~     because they may have difficulty removing all of the dietary acid load from the body in the~     urine. Participants with and without kidney disease will be recruited. Each participant will~     be fed a controlled diet for one week with sodium bicarbonate and for one week without~     sodium bicarbonate to evaluate these changes. The investigators will also determine if the~     effect of dietary acid load reduction is different in patients with kidney disease compared~     to those without kidney disease.~   "
48090|NCT02427581|"~     The most important consideration in the design of this clinical trial is to ensure the safe~     translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug~     Administration (FDA) dictates that initial studies of biologic therapies be performed in~     such a way that there is a balance between the potential risks and benefits in individual~     patients. Consistent with these recommendations, the investigators will target patients with~     triple-negative breast cancer who do not have a pathologic complete response after~     neoadjuvant chemotherapy. These patients typically have no gross evidence of disease~     following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy)~     but are at extremely high-risk for disease recurrence. Targeting this patient population~     provides a window-of-opportunity to design and manufacture the personalized cancer vaccines,~     maximizes the potential benefit from the vaccine as the regulatory networks associated with~     metastatic disease are not present, and balances risk in this patient population with~     extremely high risk for disease recurrence but no other treatment options.~   "
48091|NCT02427568|"~     This small study is designed to provide information on whether MDMA-assisted psychotherapy~     is safe and helpful for people with anxiety related to a life-threatening cancer or~     neurological illness. The research is to see if psychotherapy combined with MDMA in a~     therapeutic setting can ease anxiety in the face of a life threatening illness. Once~     enrolled in the study, people will either receive two day-long psychotherapy sessions with~     MDMA or placebo, with five people getting placebo and 13 getting MDMA. Anxiety, depression,~     sleep quality, attitudes toward death, posttraumatic growth, mindfulness, self-compassion,~     and overall quality of life will be measured at the start of the study and after these two~     sessions. People close to the participant will also complete questionnaires about the~     participant during the study on their mood and behavior. Participants who received placebo~     can enroll in Stage 2, during which they will receive three psychotherapy sessions with~     MDMA, and participants who received MDMA will have a third MDMA-assisted experimental~     session. Anxiety and other symptoms will be measured again six and 12 months after each~     participant's final experimental session.~   "
48092|NCT02427555|"~     The main objective is to investigate gut microflora composition in relation to~     cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a~     barley kernel based product on these variables.~   "
48093|NCT02427542|"~     This is a feasibility trial designed to test the feasibility and acceptability of a brief~     form (six sessions) of Cognitive Behavioural Therapy (CBT) for~     Depersonalisation/Derealisation (DP/DR) in those individuals who also have a diagnosis of a~     psychotic disorder. Participants will be randomised to receive either six sessions of CBT~     targeting DP/DR symptoms or to a treatment as usual control condition.~   "
48094|NCT02427529|"~     Subjects are female patients, randomized to HCG group or placebo group, during a prospective~     trial, in order to determine the significance, if any, of HCG on maintaining muscle mass~     during a very low calorie diet in order to demonstrate the potential significance of HCG~     administration on preserving lean body mass while losing weight.~   "
48431|NCT02423135|"~     The aim of the proposed project is to perform a clinical study in which volunteers will~     receive autologous blood transfusions in DEHP-free blood bags.~   "
48096|NCT02427503|"~     Inflammation of the nasal and bronchial mucosa characterizing rhinitis and asthma are~     probably manifestations of the same disease. Multiple functional observations, pathogenic~     and clinical support that assertion. It is noteworthy that most asthma patients, who~     underwent a nasal endoscopic polypectomy, improve your asthma after surgery. This~     improvement would be related to the administration of oral steroids that these patients~     usually receive after surgery, or the disappearance of nasal discomfort caused by nasal~     polyps to improve ventilation. But this does not explain why this improvement, in some cases~     lasting for months after the operation, and without receiving oral steroids. It is~     speculated that severe nasal inflammation due to nasal polyps stimulate the bone marrow to~     produce more eosinophils, an increased supply of blood eosinophils, and consequently, a~     major bronchial eosinophilic inflammation, aggravating asthma. However, it is noteworthy~     that studies have evaluated the clinical impact in asthma after endoscopic nasal~     polypectomy, are scarce or performed on a small number of cases, the results are~     inconsistent and do not allow categorically whether or not such positive association. And~     more importantly, none of them included measurements of airway inflammation and hypothesized~     relationship between bronchial eosinophilic inflammation and nasal polyposis, aclarar.La~     remains finding that provides nasal endoscopic polypectomy objective improvement of severe~     asthma it could be a future therapeutic option to consider in patients with asthma and~     rhinosinusal polyposis.~   "
48097|NCT02427490|"~     In congruence with the National Cancer Institute's commitment to supporting families of~     individuals with cancer across the full disease trajectory, the investigators seek to~     examine the feasibility of a technologically-mediated problem-solving intervention designed~     to improve the quality of life and decrease the psychological distress of family caregivers~     of cancer patients receiving outpatient palliative care. Investigators involved in this~     mixed methods pilot study will collect and analyze both quantitative and qualitative data,~     which will subsequently inform a large-scale randomized clinical trial of the~     problem-solving intervention.~   "
48098|NCT02427477|"~     Approximately 120 subjects will be comparing two soft contact lenses for one week each.~   "
48099|NCT02427464|"~     The purpose of this study is to determine the safety and efficacy of bilateral intramuscular~     injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.~      A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:~      Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects~      Randomization will be stratified by current use of gabapentin and/or pregabalin.~   "
48100|NCT02427451|"~     This phase Ib/II trial studies the best dose and safety of Bcl-2 inhibitor GDC-0199 in~     combination with obinutuzumab and ibrutinib and to see how well they work in treating~     patients with chronic lymphocytic leukemia that has returned (relapsed), does not respond to~     treatment (refractory), or is previously untreated. Bcl-2 inhibitor GDC-0199 and ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as obinutuzumab, may block cancer growth in different ways by~     targeting certain cells. Giving Bcl-2 inhibitor GDC-0199 together with obinutuzumab and~     ibrutinib may be a better treatment for chronic lymphocytic leukemia.~   "
48101|NCT02427438|"~     The primary purpose of this study is to assess the effect size of the change in Oswestry~     Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video~     based instruction or standard of care hand-out with pictures and written instructions for~     subjects meeting the clinical prediction rule for lumbar stabilization.~      The second purpose will be to determine if there is a subset of physical examination and~     self-reported variables that are associated with having a successful result (ODQ improvement~     by at least 6 points) and if the subset of variables are affected by whether or not the~     subject was in the intervention (video) or control (handout) group.~   "
48102|NCT02427425|"~     Introduction: Low back pain is one of the most common complaints in doctors' offices, and~     acute low back pain is characterized by episodes of pain with less than three weeks~     duration. The transcutaneous electrical nerve stimulation (TENS), based on the gate control~     theory of pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy~     in the control of back pain, being a non-invasive, low cost, safe and easy to apply. No~     studies were found regarding the effectiveness of TENS in acute low back pain.~      Objective: To evaluate the effectiveness of TENS in pain management of patients with acute~     low back pain.~      Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled.~     Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP)~     according to the following criteria: acute low back pain, both genders, aged between 18 and~     65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate~     in the study. After signing the informed consent patients were randomly allocated into one~     of the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS~     with frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width~     of 60μs and intensity adjusted according to the individual baseline for each patient without~     causing muscular contraction. The electrodes were arranged in a cross shape in the~     paravertebral region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted,~     but did not occur electrical stimulus. Patients were informed that they could or could not~     feel electric shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each~     session lasting 30 '. Assessments were made at the following times: T0 (baseline), T1 to T10~     (the beginning and end of each session), T11 (after the last session), T30 (30 days after~     the last session) and T60 (60 days after the last session). Assessment tools: PNS for pain,~     short-form 36 (SF-36), Roland-Morris, self-assessment of improvement (Likert scale) and~     drug consumption (daily).~   "
48103|NCT02427412|"~     A randomized, prospective, placebo-controlled study which aims to evaluate the effect of~     combined intraarticular and intravenous Tranexamic acid on total blood loss following~     unilateral knee replacement versus only intravenous tranexamic acid.~   "
48104|NCT02427399|"~     The purpose of this project is to determine whether outreach to HIV-negative women who are~     overdue for a Pap smear at a New England urban community health center can increase cervical~     cancer screening rates among these women. It additionally seeks to determine which form of~     outreach - via letter, email, phone, or a mixture of those modalities- is most effective.~   "
48105|NCT02427386|"~     Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat.~     In view of this, many patients seek assistance in complementary and alternative medicine,~     including homeopathic treatment. The absence of evidence in the literature raises~     controversy about the effectiveness of homeopathic treatment in endometriosis. The aim of~     this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to~     placebo in the treatment of chronic pelvic pain of endometriosis.~   "
49304|NCT02411760|"~     In a single MRI exam on a research scanner, each lesion will be categorized using the~     BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified~     BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each~     approach will be determined using pathology as the gold standard.~   "
48107|NCT02427360|"~     This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with~     uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum~     species). The review of patients' records and blood samples will be performed for patients~     treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to~     December 2013.~   "
48108|NCT02427347|"~     To evaluate the effectiveness of acupuncture therapy combined with healthy education for~     patients with abdominal obesity.~   "
48109|NCT02427334|"~     Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal~     groups using computer generated random numbers. Group 1 will receive oral dienogest~     (visanne® Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group~     2 will receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo~     foe 14 days starting from the 15th day of menstruation.~   "
48110|NCT02427321|"~     This study will collect video recordings of routine flexible cystoscopy examinations,~     medical history and diagnosis information, from up to 100 participants who have a history of~     bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer~     system for recording and reviewing images of the bladder, and to assess the utility of this~     system.~   "
48111|NCT02427308|"~     The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR)~     2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar~     2015-Mar 2024.~      This study is a prospective observational study in which female patients undergoing Impavido~     who become pregnant during treatment or within 5 months after completing treatment can~     volunteer to provide information about their pregnancy and the outcome of the pregnancy.~   "
48112|NCT02427295|"~     Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with~     treated surgery with or without long acting somatostatin analogues.~   "
48113|NCT02427282|"~     This study aimed to compare the effectiveness and efficiency of miniscrew-supported and~     standard frog molar distalizing appliances.~   "
48114|NCT02427269|"~     Aim 1: To develop a prospective tissue and blood biorepository from patients with a history~     of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for~     routine care upper endoscopy for their condition.~      Aim 2: To collect clinical data from patients with a history of Barrett's Esophagus (BE) or~     esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and~     pathology data.~      Aim 3: To integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional~     flow of clinical information and specimens between laboratory and clinical scientists in~     order to foster innovative translational research.~      Aim 4: To create a biorepository for future IRB approved studies that have a tissue and/or~     blood specimen component.~   "
48115|NCT02427256|"~     The primary objective of this clinical study is to collect additional clinical data to~     support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary~     objective is to evaluate any adverse events found during the clinical study.~   "
48116|NCT02427243|"~     To assess the relative bioavailability and tolerability of two different formulations of~     crenezumab in approximately 60 healthy volunteers.~   "
48117|NCT02427230|"~     The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and~     intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary~     incontinence and improving quality of life in women with spinal cord injury (SCI).~   "
48118|NCT02427217|"~     This is a multicenter, non interventional, retrospective cohort study with a prospective,~     observational follow-up component to investigate the safety and efficacy of FCH use in~     subjects with congenital fibrinogen deficiency. Data will be collected on the safety and~     efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis~     and perioperative bleeding in these subjects. All subjects have received FCH and may~     continue to receive FCH at the discretion of the treating physician / Primary Investigator~     according to the standard of care at the participating study site.~   "
48119|NCT02427204|"~     The main questions being addressed are (1) how patient reported outcomes change during~     treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how~     much treatment costs from the payer's perspective and the patient's perspective. The~     hypothesis being tested is that treatment has a negative effect on the quality of life~     during treatment. The negative effect is expected to be temporary. Successful treatment,~     which is equated with a virological cure of the infection, is expected to result in an~     improvement in quality of life compared to baseline and to improvement in markers of liver~     function and liver status. Costs of treatment are expected to be $80,000-$200,000 per~     virological cure.~   "
48120|NCT02427191|"~     Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection~     as compared to the saline placebo injection in the treatment of plantar fasciitis~   "
48121|NCT02427178|"~     The purpose of this study is to find out if a stem cell transplant is safe for patients with~     a very rare disease. The stem cell transplant is called AHSCT (for allogeneic hematopoetic~     stem cell transplantation). The rare disease is called MNGIE (for Mitochondrial~     NeuroGastroIntestinal Encephalomyopathy). Patients with MNGIE will be transplanted with~     stem cells from an individual who is human leukocyte antigen (HLA) 10/10 matched. The~     purpose of the transplant is the production of thymidine phosphorylase.~   "
48122|NCT02427165|"~     The number of people with of asthma and allergy is still increasing and a large number of~     patients still do not have their asthma well controlled. There is therefore a need for new~     asthma treatments that work well and have less side effects. The study compares a new~     experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.~   "
48146|NCT02426853|"~     The goal of this research study is to learn how students react to seeing a photograph of any~     skin damage they may have on their face. This skin damage may be caused by sun exposure or~     use of tanning beds. Researchers also want to learn about students' sun protection, tanning~     behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin~     cancer.~      Researchers will use the results of this study to design programs for students about sun~     protection and tanning avoidance.~   "
49317|NCT02411591|"~     This is medical research evaluating the safety and efficacy of two new medicines~     (necitumumab and abemaciclib), administered in combination in participants affected by a~     defined type of advanced lung cancer (stage IV non-small-cell lung cancer).~   "
48123|NCT02427152|"~     Obesity is considered to be caused by an imbalance between energy expenditure and energy~     intake. A major determinant of our daily energy intake is the size of the meals that we~     consume. It has been suggested that decisions about portion sizes are often made in advance,~     before a meal begins. This pre-meal planning is considered to especially depend on the~     estimated 'expected satiety' and 'expected satiation' of different foods. Further, also~     factors like weight concern and palatability of the food might have their influence on meal~     size selection. In general, it is not clear how these factors are integrated during pre-meal~     planning and which brain networks are involved in these decisions/this process. Thus, the~     investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese~     individuals with functional magnetic resonance imaging under different cognitive~     instructions including pleasure, expected satiety and self-control in terms of health~     consequences. The investigators will explore the neural networks involved in pre-meal~     planning and expect them to be modulated by the before mentioned factors. Further, the~     investigators plan to explore gender differences and expect that female subjects will select~     smaller portion sizes especially in the self-control condition as they are often more~     concerned about their weight/health. Finally, the investigators will explore differences~     between lean and overweight subjects to elucidate factors that might lead to increased meal~     sizes in overweight subjects.~   "
48124|NCT02427139|"~     The specific aim of the study is to do comparison between ANSiStim and Placebo for pain~     relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active~     labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative~     patients with good pain relief .~   "
48125|NCT02427126|"~     Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active~     controlled, efficacy study (phase III)~   "
48126|NCT02427113|"~     The purpose of the study will be to examine the effectiveness of an innovative use of music~     on TMD. Music and rhythmic vibrations can alter the basic processes related to sensation of~     pain in the brain. As well, music can block the neurological pathways that transmit pain~     sensations and thereby reduce pain. Music and vibrations are relaxing, reduce stress, and~     thereby reduce sensitivity to pain.~   "
48127|NCT02427100|"~     The proposed study will utilize a randomized controlled trial design to pilot-test a 4-week~     shelter-based diet and physical activity intervention in a sample of homeless adults~     residing in the transitional shelter at The Bridge Homeless Assistance Center in Dallas, TX~     (N = 50). Participants will be randomly assigned to a diet/physical activity intervention~     group (n = 25) or a paid assessment-only control group (n = 25). Three intervention~     strategies will be employed: 1) computer-tailored newsletters adapted from a program~     supported for use in other populations, 2) the distribution of fruit and vegetable snacks~     directly to individuals, and 3) the provision of pedometers and walking goals. Thus, the~     primary aim of the proposed study is to 1) evaluate the feasibility and effectiveness~     (relative to an assessment-only control group) of a shelter-based intervention designed to~     improve dietary intake and increase physical activity among homeless individuals. The main~     study outcomes will be average daily fruit and vegetable consumption and objective~     pedometer/ accelerometer assessment of physical activity (assessed weekly) over the 4-week~     study period, and at a follow-up assessment 4 weeks after the conclusion of the~     intervention. Secondary aims will focus on: 2) identifying intervention-related differences~     (relative to the control group) in indicators of physical health including blood pressure,~     weight, body mass index (BMI), waist circumference, and other dietary variables (i.e.,~     caloric intake, meals consumed outside of the shelter, daily fat and fiber intake) and 3)~     identifying psychosocial variables associated with dietary quality and physical activity.~   "
48128|NCT02427087|"~     Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver~     Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of~     the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to~     75 years, diagnosed with NAFLD and were followed for a period of six months. All patients~     underwent anthropometric and body composition, as well as analysis of clinical, laboratory~     before and after 6 months of exercise training protocol established.~      The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It~     is expected that the intervention of physical activity causes a decrease or no weight,~     decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis~     model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.~   "
48129|NCT02427074|"~     Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are~     analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and~     salivatory functions are analysed as well.~   "
48130|NCT02427061|"~     Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents~     and associated with poor health. Global health organizations highlight engaging men and boys~     in preventing violence against women as a potentially impactful public health strategy. This~     study aims to test, via a two arm cluster randomized controlled trial, a gender~     transformative SV/ARA perpetration prevention program among African American adolescent~     males ages 13-19 (target is high school age) implemented in a community-based setting.~     Gender transformative refers to a theory- and evidence-based approach to alter gender~     norms that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to~     interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the~     acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA~     perpetration, this program integrates analysis of social norms that condone violence against~     women, sexual health promotion, and skills in bystander intervention -- an approach that has~     been implemented in multiple non-U.S. settings among young adult males with reductions in~     violence, development of more equitable gender attitudes, and less risky sexual behaviors.~     This will be the first test of such a gender transformative program among adolescent males~     in the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters,~     N=840 adolescent males ages 14-19), this study will assess the effectiveness of Manhood~     2.0 (proposed name for this gender transformative program) compared to a job skills~     curriculum. Three months after the end of the program (Time 2), compared to controls, youth~     will demonstrate increased positive bystander intervention behaviors (secondary outcome).~     Intermediate outcomes are: condom use self-efficacy; contraception use attitudes;~     recognition of abusive behaviors; gender-equitable attitudes; and intentions to intervene~     with peers. Nine months after intervention completion (Time 3), youth will report less~     perpetration of SV and ARA toward females (Primary Outcome) compared to controls. This study~     will provide urgently needed information about the effectiveness of a gender transformative~     program that combines healthy sexuality skills, gender norms change, and bystander skills to~     interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among~     adolescent males.~   "
48131|NCT02427048|"~     This study will develop and test an intervention given to emergency medicine providers to~     improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.~   "
48132|NCT02427035|"~     This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose~     study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult~     subjects with moderate renal impairment and in healthy adult subjects with normal renal~     function.~   "
48133|NCT02427022|"~     Clinical social workers and other staff providing direct care to individuals experiencing~     homelessness face multiple challenges in obtaining training and implementing evidence-based~     practices in diverse community settings. Critical Time Intervention (CTI) is an increasingly~     popular evidence based practice with these agencies.~      With funding from a Phase II Small Business Innovation Research grant from the National~     Institute of Mental Health, the Center for Social Innovation developed an online multi-media~     training on CTI which incorporates a Community of Practice approach to encourage peer-based~     learning.~      The primary aim of this longitudinal, randomized-control study is to compare and contrast~     this online training modality with a face-to-face training on implementation of and fidelity~     to the CTI model over time. Nearly two-hundred direct service providers from 20~     homeless-service agencies were randomly assigned to complete either an online or~     face-to-face training in CTI. Pre-post training and knowledge-retention surveys, interviews~     with trainers, agency administrators, and providers were conducted to track satisfaction~     with the training and experiences in implementing CTI. CTI-specific chart forms are used to~     assess fidelity to the CTI model, and administrative data from the agencies capture~     client-level outcomes.~   "
48134|NCT02427009|"~     The main objective of this study is to assess the rate of recurrence of headache following a~     first blood patch where patients will be positioned in the prone position for an hour after~     each blood patch needed during this study.~   "
48135|NCT02426996|"~     The main objective of this study is to evaluate, after surgery for chronic anterior shoulder~     instability using a Latarjet technique with positioning of the bone block via an SEM~     positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery~     in the decision to return to activity early as conditioned by the quality of the bone block~     consolidation.~   "
48136|NCT02426983|"~     Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation~     which uses a very weak constant current to temporarily excite the brain area of interest via~     small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate~     mental processes (cognition) and motor function (movement) in healthy controls and to treat~     neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has~     been found to improve motor processes and cognitive performance, including attention and~     memory functions. This study will attempt to examine the effects of tDCS on a specific~     aspect of short term memory to sounds measured from electrical activity (EEG) from the top~     of the scalp. This study will also assess the effect of a drug, dextromethorphan (DMO),~     commonly found in cough syrup, which is thought to regulate tDCS treatment through brain~     receptors. The study involves four laboratory test sessions. EEG assessments will be done in~     two sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity~     locally), one session with DMO treatment and one with placebo treatment, and two sessions~     involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo~     treatments. These findings will contribute to our understanding of the brain chemistry~     involved in tDCS treatment and its effects on cognitive abilities.~   "
48137|NCT02426970|"~     The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II~     questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability~     Index, ODI) at 6 months.~   "
48138|NCT02426957|"~     The study will use a two group randomized controlled trial to compare a brief motivational~     interviewing (MI) intervention to TAU with 50 adolescents psychiatrically hospitalized for a~     suicide plan or attempt who have co-occurring alcohol use. Data will be collected via~     in-person interviews and self-administered questionnaires at baseline and 3 month follow-up~     assessments to explore outcome changes in negative alcohol expectancies, confidence in~     ability to handle situations where alcohol is present, likelihood of receiving alcohol~     treatment, frequency of alcohol use, and suicidal ideation, suicide planning, and suicide~     attempts for adolescents receiving the intervention relative to TAU.~   "
48139|NCT02426944|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%.~     Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The~     source of a cardioembolic event is a thrombus, which usually forms in the left atrial~     appendage (LAA). The prevention of cardioembolic events involves treatment with~     anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g.~     warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some~     of which can be life threatening. Recently, two new options for thrombus prevention have~     been developed. The first is the novel anticoagulants (NOAC), which were associated with~     slightly better safety profiles due to a lower frequency of intracranial bleeding in large~     randomized trials . The second option involves interventional occlusion of the LAA. The aim~     of this project is to compare the LAA occlusion intervention to NOAC pharmacological~     treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic~     event.~   "
48140|NCT02426931|"~     This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid~     ureterorenoscope for the treatment of renal calculi using a prospective, randomized~     multicentre trial design. Half of participants will receive retrograde intrarenal surgery~     using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will~     receive retrograde intrarenal surgery using the classic flexible ureteroscope.~   "
48141|NCT02426918|"~     The primary objective of this study is to evaluate the efficacy of 2 different doses of~     intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in~     the treatment of patients with staphylococcal ABSSSI.~   "
48142|NCT02426905|"~     A study to review Wilson disease patients who have previously been prescribed d-~     Penicillamine but were changed to trientine as treatment for their disease, and to follow~     them for a further 12 months.~   "
48143|NCT02426892|"~     The goal of this clinical research study is to learn if nivolumab combined with ISA101 can~     help to control cancer that has spread. The safety of the study drugs will also be studied.~   "
48144|NCT02426879|"~     There is no world-wide consensus on the oncological benefit versus increased morbidity~     associated with three field lymphadenectomy in patients with esophageal cancer and cervical~     lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three~     field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes.~     However, in Western countries patients with cervical lymph node metastases are generally~     precluded from curative treatment.~   "
48147|NCT02426840|"~     Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long.~     Some of the HIV medications can negatively impact the health of the bone and is even more~     exacerbated in perinatally HIV-injected children and adolescents because this is the period~     when the bone peaks. Bone loss during this period can be devastating and increase the risk~     for developing weak bones later in life. Supplementation of calcium and vitamin D have not~     been well studied in HIV-infected children and adolescents in developing countries.~     Therefore it is not clear whether higher doses of these supplementations can thwart the~     damages or not.~   "
48148|NCT02426827|"~     The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS)~     for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence~     of cerebral vasospasm.~   "
48149|NCT02426814|"~     The purpose of this study is to assess the use of a mobile health intervention to improve~     adherence to asthma medication among adolescents. The intervention consists of an inhaler~     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and~     incentivize patients to use their medication. This study will assess medication use~     throughout a 12 week study in patients who receive a mobile app with reminders, asthma~     control as measured by the ACT [asthma control test], and lung function as measured by~     spirometry.~   "
48150|NCT02426801|"~     The purpose of this study is to assess the feasibility of using a mobile health intervention~     to improve adherence to asthma medication among adolescents in an urban clinic setting. The~     intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile~     phone application to remind and incentivize patients to use their medication. This study~     will assess the feasibility and acceptability of this intervention to patients.~   "
48151|NCT02426788|"~     Brief Summary: Persistent Physical Symptoms (PPS; also known as medically unexplained~     symptoms - MUS) is a term used to describe a range of physical health difficulties that~     people can experience and for which the exact cause is unclear. Between 20 and 40% of~     patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS~     common, but the overlap across different patient groups may indicate that these phenomena~     are transdiagnostic. PPS are associated with profound disability and high health care costs,~     and if left untreated the prognosis of these patients is poor. There is an accumulating body~     of evidence demonstrating that cognitive behavioural interventions can reduce levels of~     symptoms and improve functioning in patients with PPS. A pragmatic RCT was designed to~     evaluate the clinical and cost-effectiveness of cognitive behavioural therapy (CBT) +~     Standard Medical Care (SMC) versus Standard Medical Care alone, in the treatment of patients~     with PPS. The trial will focus on patients with a variety of symptoms (e.g., non-cardiac~     chest pain, fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and~     rheumatology). Patients who have been referred to secondary care in the past six months will~     also be recruited from General Practice (GP) surgeries.~   "
48152|NCT02426775|"~     A Phase IIIb (Three b), Randomized Multicentre Comparative Trial to Evaluate the Long Term~     Effectiveness & Safety of the use of Carglumic Acid (Carbaglu®) in Patients with Propionic~     Acidemia (PA) or Methylmalonic Acidemia (MMA). Carbaglu® clinical experience in Organic~     Acidemia (OA) is limited to a non-comparative retrospective collection of data from patients~     who had received Carbaglu® for 1 to 15 days.~      There is no current evidence supporting the use of carglumic acid for the chronic management~     of patients with OA. The investigators are proposing a randomized multicentre prospective~     clinical trial to evaluate long-term effects of the use of Carbaglu® (50mg/kg/day) combined~     with standard chronic therapy in patients with PA and MMA compared to standard chronic~     therapy alone.~   "
48153|NCT02426762|"~     The purpose of this study is to evaluate the short-term effect of sealant-assisted skin~     closure in prevention of surgical site infection after laparoscopic surgery.~   "
48154|NCT02426749|"~     This proposal aims to investigate the effect of a promising treatment for persistent post~     Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective~     technique along with standard clinical assessments. The treatment tool is the application of~     repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex~     (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be~     objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with~     clinical and standard assessments.~   "
48155|NCT02426736|"~     In this factorial design study, 280 participants having outpatient, arthroscopic shoulder~     surgery will be randomized into 4 equal sized groups. All participants will receive a~     standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the~     intravenous or perineural (by the nerve with the nerve block) route just prior to their~     surgery. The purpose of this study is to determine which dose and route of dexamethasone~     provides the longest duration of pain control and the fewest side effects after surgery. The~     investigators hypothesize that giving dexamethasone by the perineural route, and by higher~     doses, will result in the longer durations of pain control, without increased side effects.~   "
48156|NCT02426723|"~     This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or~     refractory MM:~        -  Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the~          maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review~          Committee (SRC).~        -  Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding~          followed by cohort expansion at the combination therapy MTD or optimal dose as~          determined by the SRC.~   "
48168|NCT02426567|"~     Current evidence suggests that the gut microbiota and dietary influences are as important as~     genetics in the aetiology of Crohn's disease (CD). We have recently shown that disease~     improvement, following treatment with Exclusive Enteral Nutrition (EEN), coincided with~     changes in the gut microbiota.~      The main purposes of this study are: a) to explore whether the gut microbiota changes we~     observed in this previous study in children with CD during EEN are disease specific or not,~     and b) to develop a novel food-based diet (Crohn's Disease TReatment-with-EATing/CD-TREAT~     diet) which will induce changes to the metabolic activity and bacterial composition of the~     gut microbiota of healthy people, similar to those seen on EEN, the first-line treatment for~     active paediatric CD.~      This study will produce high quality scientific evidence to move the CD-TREAT diet towards a~     preliminary clinical trial in patients with CD which is currently inappropriate and~     unethical to carry out in people with active CD undertaking contemporary medical treatment.~   "
48157|NCT02426710|"~     Background: Radiofrequency ablation of typical atrial flutter present the most effective~     treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant~     anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the~     achievment of complete bidirectional block across the CTI is sometimes chalenging.~     Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the~     anatomy of the atria and also for the location of catheter position on CTI during ablation.~     If the routine use of ICE is associated with easier atrial fluter ablation is not clear.~      Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will~     be enrolled into the study. The patients will be randomized into group (A) ablation with use~     of ICE and (B) ablation without ICE. The ablation will be done in both groups by two~     diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter~     positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the~     ablation is the achievment of the bicidrectional block across the CTI. The end-points of the~     study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation~     time. The safety end-point is clinically significant bleeding from the groin due to~     additional puncture for ICE catheter.~      Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery,~     fluoroscopy time and the length of the procedure without increasing the bleeding.~   "
48158|NCT02426697|"~     The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the~     prevention of pain induced by mobilization in patients receiving a bone metastasis radiation~     for bone metastasis irradiations~   "
48159|NCT02426684|"~     IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG~     with strict specificity. Alloantibodies are a major deterrent to access to and success of~     life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS~     patients will represent a more robust and complete technique to eliminate DSA from the sera~     of HS patients. A single dose administration of IdeS® in the pre-operative period to HS~     patients with positive DSAs and flow cytometry crossmatches will durably eliminate~     circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with~     standard desensitization therapy, result in a durable suppression of DSA levels thus~     eliminating the risk for ABMR.~   "
48160|NCT02426671|"~     The investigators propose that a novel experimental device 'MuteButton' can affect the~     awareness of tinnitus. Sound that arrives at the ears naturally will be presented in the~     form of touch patterns on the tongue. By learning to associate the sounds in the ears with~     the sound patterns on the tongue, the investigators aim to demonstrate that the brain will~     learn to discriminate the real sounds from legitimate external sounds from the imaginary~     tinnitus sounds that are created inside the brain. Tinnitus is an audiological condition~     most commonly described as 'ringing in the ears' that affects an estimated 40 million people~     globally (American Tinnitus Association; Royal National Institute for Deaf). More~     accurately, tinnitus is the perception of illusory sound that has no legitimate external~     source and normally arises from a small number of underlying neuropathologies. There are~     broadly two categories of tinnitus Somatic Tinnitus and Hearing Loss Related Tinnitus.~      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The~     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The~     objective of the study will be to determine the impact of acoustic and tactile multi-modal~     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and~     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking~     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale~     (VAS).~   "
48161|NCT02426658|"~     This pilot phase II trial studies how well pemetrexed disodium works in treating patients~     with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG)~     performance status of 3. Performance status means how well patients are able to perform~     daily activities and care for themselves. Patients with a performance status of 3 have a~     limited ability to move around. Currently, only patients who are able to perform most of~     their daily activities may receive chemotherapy, due to the side effects it may cause.~     Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help~     treat patients with stage IV non-small cell lung cancer and a lower performance status.~   "
48162|NCT02426645|"~     The aim of this study is to investigate associations between early structural cellular~     injury and microvascular alteration with progression of septic organ dysfunction according~     to total SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score).~     Patients will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma~     i-FABP) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis~     assessed by contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis~     of patients' immunological status will be conducted using an established, on-site immune~     monitoring panel.~      The ultimate goal of this study is an early identification of septic patients developing~     multiorgan dysfunction which may facilitate a timely novel intervention in the future to~     improve outcome.~   "
48163|NCT02426632|"~     The primary objective is to evaluate in a double-blinded (neither physician nor participant~     knows the treatment that the participant receives), fashion the taste of different~     JNJ-53718678 oral liquid formulations as compared to the reference formulation~     (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).~   "
48164|NCT02426619|"~     This randomized clinical trial aims to compare the effectiveness of three topical fluoride~     application protocols, namely three applications of a 30% SDF solution at yearly or weekly~     interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental~     caries in the primary teeth of preschool children over 30 months.~   "
48165|NCT02426606|"~     The purpose of this study is to assess the effects of consuming various lentil varieties in~     mixed-meals (containing either white rice or white potato) on post-prandial blood glucose~     and insulin as compared to white rice or white potato alone.~   "
48166|NCT02426593|"~     This study will be conducted to collect anatomical data in an ambulatory healthy population~     to aid in the development of a novel non-invasive technology to assess changes in lung~     hydration status. It will also help in developing reference ranges of lung hydration status~     in healthy subjects and their associated changes with time.~   "
48167|NCT02426580|"~     This study is a prospective randomized controlled pilot trial. The investigators will use~     wechat intervening dietary protein intake in patients treated with peritoneal dialysis.~   "
48171|NCT02426528|"~     This cluster randomized trial will test the affect of individual participation in~     culturally- and socially-related activities on health and well-being, in comparison also~     with the classic individual determinant, in relation to urban renovation schemes.~     Investigators will using a questionnaire based on several areas such as individual~     psychological well-being (PGWBI), individual happiness positioning (Keyes Scale) and health~     status perception (SF-12 Health Survey). Secondary outcomes will be related to social~     capital density (relationships and trust), culture (participation) and religion. The survey~     will be undertaken in a mid-size Italian metropolitan area, namely the Metropolitan City of~     Bologna.~   "
48172|NCT02426515|"~     This study is looking to see whether cooling the face using a special cooling device~     (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and~     discomfort patients feel after the procedure. The surgical removal of lower third molars~     (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this~     study shows that application of cold before and throughout the procedure is a simple way to~     reduce post-operative symptoms, it could benefit thousands of patients every year.~   "
48173|NCT02426502|"~     Patient failure to take medications as prescribed (medication non-adherence) is now~     identified as an important cause of kidney transplant failure. The availability of new drugs~     that are taken once daily may improve patient adherence compared to older drugs that had to~     be taken twice per day. In this study, patients will be converted to a medication schedule~     where all medications are taken once daily with the goal of improving patient adherence and~     satisfaction.~   "
48174|NCT02426489|"~     The purpose of the study is to assess whether the addition of positron emission mammography~     will add diagnostic value to magnetic resonance imaging of the breast, in patients with~     lesions of the breast that are suspicious enough to warrant biopsy, or which have been~     confirmed as containing cancer cells.~   "
48175|NCT02426476|"~     Pain initiates a stress response that increases sympathetic output and leads to autonomic~     imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic~     function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn~     to restore autonomic balance by developing 'HRV Coherence'. Patients in HRV Coherence have~     improved mood and cognition. The investigators' pilot study showed that HRV-B alleviated~     chronic pain and stress among Veteran Pain Clinic patients. HRV-B thus has a pivotal role in~     managing pain. The proposed project is a randomized, sham-controlled, biobehavioral~     intervention with HRV-B to test the hypotheses that HRV-B increases HRV coherence and~     reduces pain, stress, fatigue, insomnia and depression and improves sleep, activity, and~     cognition in Veterans with chronic neuromuscular pain. The investigators hypothesize that~     HRV-B will (1) reduce self-reported pain and stress ratings, (2) improve objective measures~     of actigraphic sleep parameters (sleep latency, duration, efficiency, fragmentation),~     rest/activity rhythms (dichotomy index, interdaily stability) and cognitive function~     (reaction time, attention); and (3) alleviate self-reported fatigue and depression symptoms.~     Patients from two groups will be randomized to the investigators' previously established~     HRV-B or sham protocol (n=40 each), and will complete a baseline assessment, 6 weekly~     training sessions, a post-training assessment, and 4-week and 8-week follow-up evaluations~     post-training. Portable, hand-held, data-logging devices will be used to practice attaining~     HRV coherence at home by the active HRV-B training group, while those in the sham training~     group will get a 'stress squeeze ball'. Standard methods will quantify HRV coherence and~     other HRV measures, and validated instruments will be used to assess pain, stress, fatigue,~     insomnia, depression, and cognitive function. Wrist actigraphy will be used to objectively~     characterize insomnia via continuous recordings collected 24-hrs/day over three 1-week~     periods (pre-training, post-training, and at the 4 week follow-up assessments. Tests~     measuring attention and reaction time will assess changes in cognitive performance. Data~     analyses will apply linear models for repeated measures to evaluate the effect of HRV-B on~     study outcomes, and on treatment persistence, after adjusting for confounding factors. This~     study will be the first to examine HRV-B for pain management among Veteran chronic pain~     patients.~   "
48176|NCT02426463|"~     Children differ from adults with respect to growth and development but also immaturity of~     various pharmacological mechanisms. Dosing schemes in children are usually derived in an~     empirical manner from clinical trials in adult patient groups. All this poses neonates to an~     increased risk for therapeutic failure and adverse drug reactions.~      Medicinal products studied during this project are among the ones with the highest needs for~     research in the pediatric intensive care. This project focuses on the necessity to integrate~     subject's individual characteristics to assist clinical decision-making in drug therapy. The~     investigators explore the mechanisms defining the dose response in pediatric populations.~     The results obtained with these studies will help to find safer drug dosing regimens in this~     delicate patient population.~   "
48177|NCT02426450|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy and liver transplantation are considered to be standard curative therapies for~     HCC. When surgery is not possible, percutaneous ablation is usually considered to be~     alternative treatments for HCC. Recurrence is the most frequent serious adverse event~     observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an~     effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%.~     Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients~     with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or~     because of widespread recurrence. Radiofrequency ablation has been considered to be one of~     the most effective percutaneous ablations for early-stage HCC in patients with or without~     surgical prospects. Studies using RFA to treat HCC recurrence after hepatectomy have~     reported a 3-year survival rate of 62% to 68%, which is comparable to those achieved by~     surgery. RFA is particularly suitable to treat HCC recurrence after hepatectomy because~     these tumors are usually detected when they are small, and because RFA causes the least~     deterioration of liver function in the patients. However, according to our previous study,~     investigators found the recurrent rate after RFA was higher than 60%. Systemic chemotherapy~     is considered to be one of the main treatments for malignant tumors. HCC is known to be~     highly refractory to conventional systemic chemotherapy because of its heterogeneity and~     multiple etiologies. Before the advent of the molecular-targeted agent sorafenib, which has~     subsequently become the standard of care, no standard systemic drug or treatment regimen had~     shown an obvious survival benefit in HCC. Nowadays, there is no systemic chemotherapy~     regimen had been definitively recommended as the standard for treating HCC. Clinical~     activity of several regimens containing oxaliplatin (OXA) in advanced HCC had been~     demonstrated in phase II studies. In a phase II study of the FOLFOX4 (infusional~     fluorouracil [FU], leucovorin[LV], and OXA) regimen in Chinese patients with HCC, median~     overall survival (OS) was 12.4 months, mean time to progression was 2.0 months, and the~     response rate (RR) was 18.2%. The safety profile was acceptable. Recently, the results of a~     phase Ⅲ randomize study showed that FOLFOX4 served as palliative chemotherapy can induce~     higher overall survival, progression-free survival and response rate comparing to~     doxorubicin in patients with advanced hepatocellular carcinoma from Asia. The safety data~     was also acceptable. Therefore, investigators considered RFA to be an effective treatment~     for HCC recurrence after curative treatment. So our hypothesis is that RFA combined with~     FOLFOX4 can reduce high recurrence rate after RFA for recurrent HCC after hepatectomy. The~     aim of this open-lable, single prospective study is to evaluate the efficacy and safety of~     RFA combined with FOLFOX4 systemic chemotherapy for recurrent HCC after partial hepatectomy.~   "
48213|NCT02425982|"~     The study aims to investigate the natural course and the results of operative treatment of~     chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a~     year. The investigators will also study the effect of pain catastrophising on the subjective~     outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE.~     The study will also ascertain the feasibility of a multi-center randomised, controlled trial~     (RCT), and test and refine the co-operation and interaction of the planned RCT centers.~   "
49318|NCT02411578|"~     The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon)~     is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes.~   "
48178|NCT02426437|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data has shown that COPD is associated with substantial cardiovascular~     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in~     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk~     with stable COPD, and the exaggerated CV risk during exacerbations of the disease are~     unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up~     of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a~     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies~     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.~     Disease management programs, such as pulmonary rehabilitation and patient self-management~     education, are part of guideline therapy for COPD; however, these are not regularly~     implemented following a hospitalization, and how these interventions affect patient~     outcomes, behavior, physical activity, inflammation and CV risk have not been well studied.~     The proposed long-term project will examine how early referral to chronic disease management~     programs after hospital discharge, affect patient outcomes. This study will provide~     invaluable information about outpatient management for a disease which has a tremendous~     impact on healthcare.~   "
48179|NCT02426424|"~     This is a prospective randomized open label trial with control-to-treatment cross-over. The~     investigators wish to assess the effectiveness and safety of immediate detection and~     treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients~     with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better~     neurological outcome and more successful rehabilitation.~      The study will enroll 140 subjects which will be randomized into one of two arms:~        -  Investigational - The sleep study will be performed during the index hospitalization~          with acute stroke. Following the diagnosis of sleep apnea, patients will be treated~          with C-PAP both during the hospital stay and after discharge.~        -  Control group -Will receive standard medical care. Patients will undergo sleep study at~          3 months following discharge and patients diagnosed with sleep apnea will be treated~          with C-PAP.~   "
48180|NCT02426411|"~     The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two~     dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with~     postherpetic neuralgia.~   "
48181|NCT02426398|"~     This is a non-invasive study investigating whether EEG, which is used in routine clinical~     care can be useful in diagnosing dementia. Novel in house developed software will analyse~     EEG data for this purpose from people with Alzheimer's disease and healthy volunteers.~   "
48182|NCT02426385|"~     The study is an observational non-randomised controlled study comparing the visual acuity~     after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC~   "
48183|NCT02426372|"~     The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety,~     tolerability, compliance, mechanism of action and efficacy of QBECO site specific~     immunomodulation for the induction of clinical response and remission in subjects with~     moderate to severe ulcerative colitis~   "
48184|NCT02426359|"~     This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to~     evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate~     to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day~     for 8 consecutive weeks.~   "
48185|NCT02426346|"~     Community-based programs are needed to improve dissemination of efficacious treatment for~     adolescent obesity. The current study aims to modify a community-based program, delivered~     through the YMCA, to increase its effectiveness with adolescents. Adolescents will be~     randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored~     for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured~     physical activity, and self-efficacy, assessed at 4 months and 10 months following~     randomization.~   "
48186|NCT02426333|"~     The purpose of this study is to explore whether early abiraterone exposure is related to~     treatment response in patients with metastatic castration resistant prostate cancer.~     Furthermore to explore the relation between biomarkers and treatment response and drug~     exposure.~   "
48187|NCT02426320|"~     The purpose of this study is to estimate the hypothesized benefit of sedation interruption~     protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate~     recruitment rates, and adherence rates of such protocol.~   "
48188|NCT02426307|"~     TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However,~     recent clinical experience has suggested that subclinical aortic valve bioprosthesis~     thrombosis may occur early after valve replacement. The frequency of this potentially~     ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown,~     as this condition is difficult to detect.~      The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise~     for the evaluation of valve leaflet mobility and morphology.~      The purpose of this study is in an observational design to assess the frequency of~     subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or~     surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon~     as well as its relation to medical treatment and MACCE will be assessed.~   "
48189|NCT02426294|"~     The purpose of this study is to compare the treatment effect at week 26 between the two~     groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD,~     Pioglitazone) administration, as the third-order drug among patients whose treatment is not~     sufficient after the combined administration of Metformin and Alogliptin.~   "
48214|NCT02425969|"~     In this randomised controlled trial of patients with stable angina and documented~     intermediate coronary disease with indeterminate or grey-zone Fractional Flow Reserve~     (FFR) we will randomise patients to either optimal medical therapy alone versus optimal~     medical therapy with PCI and they will be followed up for the primary endpoint of anginal~     control as measured by the Seattle Angina Questionnaire at 3 months.~   "
49319|NCT02411565|"~     The main purpose of this Pilot Study is to test the safety, tolerability and quality of life~     in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of~     FWGE can be detected in the blood, and determine whether short-term therapy with FWGE has~     any effect on the tumor marker, cancer antigen 125 (CA-125).~   "
48190|NCT02426281|"~     Nab-paclitaxel (interchangeable with ABRAXANE and ABI-007) is a unique protein formulation~     of a noncrystalline, amorphous form of paclitaxel in an insoluble particle state.~     Nab-paclitaxel was designed to improve the chemotherapeutic effects of paclitaxel by~     exploiting endogenous transport pathways to deliver higher doses of paclitaxel to the tumor~     and to reduce the solvent-related hypersensitivity and other toxicities associated with~     Taxol® (paclitaxel) injections, the solvent Cremophor EL, and ethanol vehicle.~     Nab-paclitaxel provides more rapid tissue distribution and increased tumor accumulation~     compared to cremophor-EL paclitaxel. Mechanistically, albumin receptor-mediated transport~     across the endothelium, binding to interstitial proteins, and macropinocytic or~     receptor-mediated uptake into tumor cells as well as sequestration of paclitaxel by~     cremophor-EL may contribute to the observed differences. Furthermore, nab-paclitaxel~     synergizes with gemcitabine in preclinical models. The Cremophor EL-free medium enables~     nab-paclitaxel to be given at a higher dose and in a shorter duration without the need for~     premedication to prevent solvent-related hypersensitivity reactions. As of March 2014,~     nab-paclitaxel is approved under the trade name of ABRAXANE in over 45 countries/regions,~     including the US, Canada, India, European Union/European Economic Area, South Korea, China,~     Australia, Bhutan, United Arab Emirates, Nepal, New Zealand, Japan, Russia, Sri Lanka,~     Argentina, Hong Kong, and Lebanon for the treatment of patients with metastatic breast~     cancer. ABRAXANE is also approved for the first-line treatment of locally advanced or~     metastatic non small cell lung cancer (NSCLC) in the US, Japan, Argentina, Australia, and~     New Zealand, for treatment of advanced gastric cancer in Japan, and for first-line treatment~     of metastatic adenocarcinoma of the pancreas in the US, EU/EEA, Australia, New Zealand and~     Argentina.~   "
48191|NCT02426268|"~     The purpose of this study is to measure cerebral and lower extremity oximetry on patients~     during cardiac surgery.~   "
48192|NCT02426255|"~     The purpose of this observational epidemiological study is to investigate the management and~     the complications associated with severe trauma. Data will be analysed to answer pre-defined~     scientific projects and to improve management of these conditions.~   "
48193|NCT02426242|"~     Severe brain-injured patients require prolonged mechanical ventilation. Weaning these~     patients from mechanical ventilation is challenging. During neurologic recovery, brain~     injured patients usually present satisfactory respiratory autonomy. However, the exact~     timing of extubation is unknown and is frequently delayed because of potential inhalation.~      To date, there are no clinical signs available in the current literature that can help the~     attending physician in the decision-making process of extubation in brain-injured-patients~   "
48194|NCT02426229|"~     This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma~     and Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice~     a day for 6 months.~   "
48195|NCT02426216|"~     This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably~     alter biomarker expression, whether serum carotenoids levels are associated with biomarkers~     levels, and whether the alterations of biomarker expression may reflect the cancer risk as~     shown by cancer incidence at the end of the clinical trial.~   "
48196|NCT02426203|"~     Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy,~     dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although~     only carried out in a single UK centre, provides an excellent model for assessing right~     ventricular function. Right heart function is most commonly assessed using echocardiography,~     either transthoracic pre- and post-operatively, or transoesophageal intra-operatively.~     Measurement of tricuspid annular plane systolic excursion is the best validated and most~     commonly performed measurement for right heart function, however it may be inaccurate after~     sternotomy and pericardial opening, making accurate assessment difficult immediately after~     surgery. Therefore, we aim to compare established methods of assessing right heart function~     with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel~     reconstruction mechanism. Right ventricular function will be assessed in 51 patients who~     undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened,~     following the surgical procedure, using transoesophageal echocardiography, and at six-month~     outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid~     using both modalities. This comparison should allow the investigators to determine whether~     such a method could replace current measurement parameters for assessment of right~     ventricular function, which is important for clinical management of patients in a variety of~     settings.~   "
48197|NCT02426190|"~     The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed~     protocols and a current standard of care protocol for the purpose of identifying better~     practice for outpatient rehabilitation among patients with single total knee replacement.~     The 3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned~     electrical neuromuscular stimulation (PENS). Both medical modalities have been cleared by~     the FDA to be used in medical rehabilitation, including total knee replacement.~   "
48198|NCT02426177|"~     To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum~     hypertension.~   "
48199|NCT02426164|"~     Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief.~     Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more~     expensive than other local anesthetic alternatives. The primary aim of this investigation is~     to examine whether or not liposomal bupivacaine provides superior pain relief or clinically~     significant opioid-sparing effects versus a control to justify its cost.~   "
48200|NCT02426151|"~     To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male~     Subjects~   "
48201|NCT02426138|"~     Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes~     patients. To address this, the investigators are conducting a pilot randomized controlled~     trial of medically tailored meal delivery (MTM). The pilot study has two specific aims:~      Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure~     diabetes patients with hyperglycemia Aim 2: To determine the feasibility and acceptability~     of the program as a medical intervention and refine the program as needed for testing in~     larger studies.~      This study is a crossover randomized controlled pilot trial, where approximately 50~     participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin~     immediately, or waitlist control. After 12 weeks, the groups will crossover, with the~     waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks,~     the participants will complete assessments of their dietary quality (HEI score),~     psychosocial measures such as diabetes distress and food insecurity, along with measures of~     body mass index, blood pressure, hemoglobin A1c, and lipids.~   "
48202|NCT02426125|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     ramucirumab in combination with docetaxel in participants with urothelial cancer who failed~     prior platinum-based therapy.~   "
48203|NCT02426112|"~     Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children,~     accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD,~     affecting more than 30% of African HIV-infected older children was described by Ferrand et~     al in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways~     disease consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has~     anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of~     generalized immune activation.~      This specific aims of this project are to:~        1. Primary objective: To investigate whether adjuvant treatment with azithromycin results~          in improvement in lung function in HIV-infected children with chronic lung disease, who~          are stable on antiretroviral therapy.~        2. Secondary objectives:~             1. To investigate the intervention effect on mortality, exacerbations of lung~               disease, quality of life, morbidity.~             2. To investigate adverse events related to azithromycin treatment~      In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be~     enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central~     Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or~     placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD~     will be enrolled as a comparison group for laboratory sub-studies.~      Lung function will be assess using spirometry and the Forced expiratory volume in the first~     minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be~     compared between trial arms after 12 months of initiation of azithromycin treatment.~   "
48204|NCT02426099|"~     This is a four-week randomized controlled single blinded trial of subjects presenting with~     resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly~     assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to~     routine intensification of antihypertensive regimen , all added to previous regimen with~     unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four~     following add-on therapy initiation. The primary outcome is change in office and~     self-measurement blood pressure recorded at each visit, and secondary outcomes are~     variations in serum potassium, sodium, and creatinine levels.~   "
48205|NCT02426086|"~     The purpose of this study is to evaluate the percentage of spleen (largest lymph organ in~     the body) response and symptom response of 2 dose regimens of imetelstat in participants~     with intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to~     Janus Kinase (JAK) inhibitor treatment.~   "
48206|NCT02426073|"~     A thorough characterization of glucose metabolism and inflammaging in elderly subjects~     will help determine to what extent each of these factors affects muscle mass/function and~     contributes to age-related muscle wasting. The investigators will correlate patterns of~     insulin secretion/sensitivity with muscle quality/quantity in diabetic and non-diabetic~     elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic,~     diabetic/sarcopenic), the investigators expect to identify an oxidative/inflammatory~     signature (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific~     for the sarcopenic phenotype and related to muscle insulin resistance.~   "
48207|NCT02426060|"~     The objective of this study was to determine the effects of Imrecoxib, an~     anti-infiammatory/analgesic agent that primarily inhibits COX-2 and not COX-1 at therapeutic~     doses, on the steady-state pharmacokinetic profile and hypoprothrombinemic effect of~     warfarin in healthy volunteers.~   "
48208|NCT02426047|"~     The modified Atkins diet (MAD) has been shown to be effective in treating intractable~     epilepsy. Approximately 55% of the patients started on the diet are women of childbearing~     age and women with epilepsy often have a pattern of seizures that correlates with their~     menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an~     overall reduction in seizure frequency, some women on the MAD continue to have breakthrough~     seizures in a catamenial pattern. The investigators hypothesize that women with a history of~     intractable epilepsy who have been on the modified Atkins diet for at least 3 months and~     have a catamenial seizure pattern will tolerate and be compliant with the addition of a~     daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day~     time interval starting 2 days prior to and encompassing the primary catamenial pattern.~   "
48209|NCT02426034|"~     The purpose of this single arm study is to assess the safety and efficacy of ATAN (Apatinib)~     in patients with Chemo-refractory Advanced or Metastatic Adenocarcinoma of Stomach or~     Gastroesophageal Junction in clinical practice. ATAN will be given to patients who had~     failed at least two lines of prior chemotherapy. Eligible patients will receive ATAN~     treatment (850 mg qd p.o.) continually until disease progression or intolerable toxicity or~     patients withdrawal of consent, and the target sample size is 2000+ individuals.~   "
48210|NCT02426021|"~     The objective of the study is to investigate the safety, pharmacokinetics, and~     pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.~   "
48211|NCT02426008|"~     The investigators suppose that adding growth factors that had been found in the female tubal~     fluid and uterus to In Vitro single step culture media for human embryos might improve the~     the embryogenesis In Vitro and the clinical outcome of the resulting off spring.~   "
48212|NCT02425995|"~     Peroperatively observative study in pediatric orthopedic center in Lyon, France.~      50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of~     the medial meniscus associated with lesions of the anterior cruciate ligament.~      All the patients need a reconstruction of the ACL because of chronic knee instability.~      All the patients underwent a multi portal arthroscopy during the ACL reconstruction :~     anteromedial and anterolateral and after intercondylar and posteromedial.~      The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of~     the posterior horn of the medial meniscus which could be missed in MRI and anteromedial and~     anterolateral arthroscopy.~      Statistics of this lesions are used to study prevalence and diagnosis capacity of this~     procedures.~      First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar~     portal and after a posteromedial portal.~   "
48245|NCT02425566|"~     The purpose of this study is to better understand the role of the abdominal veins~     (splanchnic capacitance) and the sympathetic nervous system in human hypertension. The~     investigators will test the hypothesis that constriction of abdominal veins due to~     sympathetic activation contributes to human hypertension. Splanchnic capacitance will be~     assessed in normotensive and hypertensive subjects at baseline and during acute blockade of~     the autonomic nervous system.~   "
48215|NCT02425956|"~     This study is being conducted to build a library of prospectively collected clinical data~     from subjects with iron overload examined with commercially available MRI devices. This data~     library is intended for use in future engineering development and other research activities,~     including future regulatory submissions. Data from human subjects is required to develop and~     test Magnetic resonance (MR) reconstruction techniques that can provide quantitative~     information about tissue properties, such as volumetric fat and iron concentrations.~     Collection of MR data and corresponding quantitative liver iron concentration (LIC) data is~     necessary for development of MR techniques that can show both overall and regional iron~     concentrations of in vivo tissues. These techniques may provide viable alternatives to~     invasive and expensive conventional liver biopsy and to less accurate serum biomarker~     testing, potentially benefiting future clinical patients with iron overload.~      MR image data and corresponding quantitative data about serum and liver iron levels will be~     collected from each subject in this study. These datasets are considered suitable for future~     development and testing of MR reconstruction software, including MR reconstruction~     algorithms developed by General Electric Healthcare (GEHC) to use Longitudinal relaxation~     rate equal to the reciprocal of T2 relaxation time (1/T2) (R2) techniques to assess LIC. To~     achieve a sufficiently diverse library for future testing, MRI data of the liver and~     surrounding tissues will be acquired using 1.5T and 3.0T GEHC IDEAL IQ scans and~     commercially available 1.5T MRI scans conducted according to the FerriScan® Specialized~     Reconstruction Service guidelines (Resonance Health, Claremont, AU). Quantitative~     hematologic (serum ferritin) based on blood testing and FerriScan® Analysis Service LIC~     reports will be collected for each subject.~   "
48216|NCT02425943|"~     Study is designed to~        1. to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a~          single regimen for correction of wrinkle assessment score (WAS) 2 to 4 nasolabial fold~          (NLF) contour deficiencies and other facial wrinkles in which deep dermal grid pattern~          (cross-hatch) injection technique is appropriate.~        2. to evaluate the time to onset, duration, severity, relationship to Sculptra Aesthetic~          and/or injection procedure, and outcome of all adverse events during the course of the~          study, by Fitzpatrick skin type.~        3. to evaluate the change in the WAS from baseline to post-treatment follow-up time points~          at Months 6, 13, and Years 2, 3, 4, and 5 in NLFs and other facial wrinkles.~        4. to evaluate Investigator/subject global assessments at Months 6, 13, and Years 2, 3, 4,~          and 5.~   "
48217|NCT02425930|"~     This study is designed to investigate whether complement C3 depletion is associated with~     poor short-term outcomes in postoperative patients with gastric cancer.~   "
48218|NCT02425917|"~     This study is designed to compare the effect of IPC on post-operative circulation in lower~     limbs with gekoTM device after total hip replacement procedure.~   "
48219|NCT02425904|"~     This research study is evaluating a drug called clofarabine as a possible treatment for~     Langerhans Cell Histiocytosis( LCH )~   "
48220|NCT02425891|"~     This study is being conducted to determine the efficacy and safety in using Atezolizumab in~     combination with nab-paclitaxel in treating participants with metastatic breast cancer. The~     safety of single-agent nab-paclitaxel has been determined in previous studies of~     participants with metastatic breast cancer, and preliminary data shows the use of~     Atezolizumab is safe to use in combination with chemotherapy.~   "
48221|NCT02425878|"~     Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable~     intramural fibroids not distorting the uterine cavity within a program OVD, after~     administration of uPA in a dose of 10 mg orally daily for 12 weeks~   "
48222|NCT02425865|"~     PHASE: IV~      TYPE OF STUDY: With direct benefit~      DESCRIPTIVE: multicenter, open-label, uncontrolled trial~      INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed~     corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All~     included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment~     initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.~      OBJECTIVE: To determine the proportion of patients with continued clinical response (CCR)~     and endoscopic remission at week 108, after discontinuation or de-escalation of golimumab~     treatment at year 1 in the subgroup of patients in continuous clinical response (CCR) and~     with mucosal healing (MH) (endoscopic Mayo score of 0 or 1) at week 54.~      STUDY DESIGN:~      Induction Phase :~      Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg~      Phase I : Week 10-Week 54 • Patients with primary clinical response* : Standard regimen with~     golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)~      • Patients without primary clinical response* : Optimization to 100 mg Q4W (or combination~     therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already~     on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)~      • Early escape at Week 18: Primary non-responders who are still not responding at week 18 to~     dose optimization at Weeks 10 and 14 will be considered treatment failures and will be~     followed up (call or visit) at week 54 for safety.~        -  Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3~          points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from~          baseline in the rectal bleeding sub score ≥1~      Phase II : Week 54-Week 108~      • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab~     and continuation of thiopurines or methotrexate if on combination therapy~      • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation~     to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination~     therapy~      • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I~     dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)~   "
48223|NCT02425852|"~     PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open~     label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare~     the efficacy and safety of early administration of the combination therapy with infliximab~     and azathioprine with steroids and azathioprine in patients with acute severe ulcerative~     colitis treated with intravenous steroids.~      STUDY TREATMENTS : All patients :~      Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.~      Combination therapy arm:~      Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.~      Azathioprine arm:~      Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.~   "
48224|NCT02425839|"~     Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory~     dysfunction and follow up of treatment effectiveness is currently based only on clinical~     features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic~     imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in~     order to study its viscoelastic properties.~      In this study, the investigators study the correlation between changes of shear wave~     elastography modulus and surface electromyogram features of the masseters between rest and~     maximal voluntary contraction.~   "
48225|NCT02425826|"~     This study will evaluate the clinical efficacy, patients quality of life, satisfaction, and~     safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in subjects with~     moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year~     in the Extension Phase of the trial.~   "
48226|NCT02425813|"~     This phase II trial studies how well methylprednisolone sodium succinate works in treating~     patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun~     within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces~     inflammation. Giving corticosteroid drugs, such as methylprednisolone sodium succinate,~     directly into the arteries of the gastrointestinal tract may help treat inflammation caused~     by GVHD. Giving methylprednisolone sodium succinate in addition to standard treatments may~     be more effective in treating GVHD.~   "
49320|NCT02411552|"~     This initiative is a prospective study evaluating the effects of implementing physical~     activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.~   "
48227|NCT02425800|"~     This pilot research trial studies the use of a human prostate tissue model to maintain and~     study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that~     was removed during surgery from patients with non-cancerous enlargement of the prostate~     (benign prostatic hyperplasia) and may create an environment similar to the natural~     environment of the human body. Prostate cancer stem cells are cells that cause cancer to~     grow. Using real tissue to create an environment to study stem cells may help doctors learn~     more about how they work and how they respond to treatments.~   "
48228|NCT02425787|"~     Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several~     limitations in our understanding of how parents' relationships with care staff help and~     hinder their grief experience. Additionally, there is a gap in the bereavement literature~     regarding the psychological effects professional caregiver relationships have on parents~     whose children died of cancer. To bolster our knowledge base and benefit Bereavement Care~     Services at SJCRH, as well as benefit other professionals by filling the gap in the~     literature, we have designed a qualitative study that will conduct individual interviews~     with bereaved parents whose children died at SJCRH.~   "
48229|NCT02425774|"~     Hypothesis:~      Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an~     anti-inflammatory effect.~      Aims:~      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect~     of prucalopride. The following aims are formulated:~        1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve~          stimulation (VNS)~        2. to evaluate whether prucalopride leads to accelerated post-operative recovery~   "
48230|NCT02425761|"~     The purpose of the study is to compare the survival time (time to first shunt failure) of~     ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted~     through a posterior entry site in children. Shunt entry site is the location on the head~     that the shunt catheter enters the brain on its path to the fluid-filled spaces in the~     brain, the ventricles. Entry sites can be anterior or posterior.~   "
48231|NCT02425748|"~     In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation)~     in combination with tumor reducing surgery, for example cryosurgery going to be~     investigated.~   "
48232|NCT02425735|"~     In this study, effects of γδT cells on human hepatocellular liver cancer in combination with~     tumor reducing surgery, for example cryosurgery going to be investigated.~   "
48233|NCT02425722|"~     The objective of this study is to investigate dose-responses of efficacy and safety of~     ASP0456 in patient with chronic constipation (diagnosed by Rome III criteria of FC, not~     including constipation due to organic diseases) compared to placebo and to investigate the~     appropriate dose range for P3 study.~   "
48234|NCT02425709|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during outpatient hysteroscopy in postmenopausal women. Postmenopausal women~     undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the~     first group will receive Tramadol 50 mg 1 hour before the procedure, the second group will~     receive diclofenac 50mg 1 hour before the procedure and the third will receive a placebo.~     Pain will be assessed by a visual analogue scale.~   "
48235|NCT02425696|"~     The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt~     (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in~     migraineurs.~   "
48236|NCT02425683|"~     This study, for patients who have Stage IIIC colorectal cancer and who underwent~     5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to~     see if regorafenib given after the completion of FOLFOX improves treatment, compared to~     standard of care (SOC), which is no further treatment.~   "
48237|NCT02425670|"~     The purpose of this study is to determine whether patients with subacute ischemic stroke~     will benefit from infusion of patient's own bone marrow derived stem cells.~      Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30~     to 500 million in patients with subacute ischemic stroke results in reduction of infarct~     volume and improvement of neurological function compared to those without the injection.~      Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem~     cells (BMSC) will have better outcome than those receiving fewer dosages of cells.~   "
48238|NCT02425657|"~     Specially educated trainers will be responsible for colonoscopy training of junior doctors.~     The educated trainers will have attended seminars held by Valori et al.~      The following fast track colonoscopy training program for junior doctors will consist of: 1)~     Endoscopy simulation training and theory course 2) supervised and partly supervised lower~     endoscopy. 3) Directly observed practical skills according to JAG (joint advisory group)~     guidelines.~   "
48239|NCT02425644|"~     International clinical trial to compare ponesimod and teriflunomide in relapsing multiple~     sclerosis~   "
48240|NCT02425631|"~     This study will evaluate long-term follow-up of subjects implanted with the SImmetry~     Sacroiliac (SI) Joint Fusion System (SImmetry).~   "
48241|NCT02425618|"~     The purpose of this study is to investigate whether the pressure controlled ventilation can~     reduce gastric insufflation compared to the volume controlled ventilation in patients who~     were mechanically ventilated with the i-gel.~   "
48242|NCT02425605|"~     This is a single-center, single-arm, open-label, prospective phase 2 trial to assess the~     efficacy of localized concurrent chemoradiation therapy (CCRT) and sorafenib sequential~     therapy in subjects with advanced HCC. Approximately 47 subjects will be enrolled and will~     receive CCRT and sorafenib sequentially until all-cause mortality.~   "
48243|NCT02425592|"~     The objective in this study is to determine if MRI-identified progression can decrease~     frequency or need for repeated prostate biopsy in men on active surveillance (AS).~      Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men~     on active surveillance (AS) after a MRI-US fusion prostate biopsy.~   "
48244|NCT02425579|"~     The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in~     intubated patients with sepsis-induced ARDS.~   "
48264|NCT02425319|"~     The purpose of this study is to describe and to compare the motion analysis parameters, i.e.~     motion and stability of proximal interphalangeal joints, which were treated with a~     CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion~     analysis of untreated healthy hands.~   "
48246|NCT02425553|"~     Reflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular~     basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid~     or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal~     gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to~     distension during the meal.~      The effects of diet on gastrointestinal function are debated and the efficacy of dietary~     management for digestive symptoms has not been established. Epidemiological studies suggest~     an effect; however, it is not possible to distinguish the effects of fat intake and total~     energy (i.e. calorie) intake in this work. This issue has been addressed by small~     physiological studies. The results show that esophageal acid exposure was related to total~     calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40%~     higher after the high-fat than the low-fat meals. Similar findings were found for the~     relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic~     Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but~     heightens sensitivity to visceral events and so increases the number and severity of~     symptoms reported by patients. As yet, these findings have not been confirmed in larger,~     more representative surveys.~      Similar to the effects of food, there are inconsistent findings regarding the effects of~     alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have~     noted delayed gastric emptying and an increase in reflux events when alcohol is taken with~     food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic~     symptoms.~      The proposed observational, dietary study with cross-over design will assess the independent~     effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number~     and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms~     after the high calorie, high fat meals will also be documented. The study population of~     senior academics attending a conference are likely to have a relatively high prevalence of~     risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an~     older age and a larger waist circumference than average in the general community. This will~     increase study power and relevance of the findings.~      The results will provide new information concerning the impact of dietary factors and~     alcohol on digestive symptoms after meals. This data will inform future guidelines for the~     dietary management of patients with reflux and dyspeptic symptoms after meals which will be~     relevant in both primary and secondary care.~   "
48247|NCT02425540|"~     The aim of the study is to prospectively evaluate the value of pelvic MRI including~     diffusion- and perfusion-weighted sequences in the selected group of patients that have an~     undetermined ovarian mass at ultrasound.~   "
48248|NCT02425527|"~     The purpose of this feasibility study is to determine whether digital games are effective~     and acceptable in the treatment for patients with traumatic brain injury.~   "
48249|NCT02425514|"~     The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior~     Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.~   "
48250|NCT02425501|"~     The objectives of this study are to investigate the safety and effectiveness of EYLEA~   "
48251|NCT02425488|"~     Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias~     for which international guidelines suggest the implantation of an implantable cardiac~     defibrillator (ICD). The educational nursing program would improve clinical outcomes in~     patients with HF and ICD like control their sickness, known and acknowledge symptoms,~     improve their skills to self-care.~      The main aim of this study is to assess how much the nursing-therapeutics skills and an~     educational intervention, in patients with HF during the follow-up period after the~     implantation of ICD reduces clinical costs, re-hospitalizations, and mortality at 180 days.~      Methods: The investigators start a multicenter randomized clinical trial. The sample is made~     of 128 subjects (64 patients treatment group and 64 control group). The investigators~     measured the self-care level administering to HF patients the Self-Care of Heart Failure~     Index (SCHFI) v. 6.2, and the self-perception of own life quality using a Numeric Rating~     Scale from 0 to 100. Secondary outcomes recorded are i) the numbers of accesses to the ED~     (Emergency Department) and/or hospitalizations during the follow-up period, ii) mortality~     rate due to HF, and iii) infection rate of the device pocket.~      Data Analysis: Categorical variables will be presented in terms of frequencies and~     percentages. The statistical power was fixed at the 80%. Data will be considered significant~     for a p-value ≤ 0.05. The Cox proportional hazards model will be used to analyze mortality~     in subjects involved in the educational program.~   "
48252|NCT02425475|"~     All patients will undergo dermoscopic diagnosis and be documented with a video image~     storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second~     diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a~     dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the~     medical device LIMES will also be documented immediately. Afterwards, the lesion will be~     excised and undergo histopathologic examination by the respective histopathologist of the~     participating centers. The histopathologic diagnosis will serve as gold standard for~     subsequent evaluations of the diagnostic accuracy.~   "
48253|NCT02425462|"~     This study is a prospective observational cohort study. The study will be conducted in~     routine clinical practice settings. It is planned to enroll 870 patients with endometriosis~     for whom a decision has been made by the physician to treat with dienogest according to~     local health authority approved label. It is the aim of this observational cohort study to~     further characterize the effectiveness of dienogest in improving quality of life and~     long-term safety in routine clinical practice setting. Endometriosis is chronic and~     progressive disease and there is unmet need for long-term treatment. Visanne® with proven~     efficacy and safety, can be good option for long-term treatment, however, experience with~     Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and~     safety of Visanne would support the long-term treatment strategy for Endometriosis~     management in the clinical practice.~   "
48254|NCT02425449|"~     Muscle relaxants are medications used during surgery to facilitate surgical access. The~     effect of the muscle relaxant medications is measured by stimulation a motor nerve and~     measuring the force of the resultant muscle contraction. Based on the mechanism of action,~     two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the~     second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be~     distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or~     TOF). The nondepolarizing muscle relaxants produce fade ie successive muscle contractions~     are less forceful than the preceding ones. Whereas the depolarizing muscle relaxants are~     generally believed to produce four contractions of equal strength. However, there is some~     indication that this may not be entirely correct. There is evidence that depolarizing muscle~     relaxants also may produce fade. The investigators are conducting the following study to~     determine if indeed depolarizing muscle relaxants produce fade. The investigators would also~     like to characterize the fade ie differences during onset and offset of the block and the~     effect of the dose on the degree on the fade.~   "
48283|NCT02425072|"~     The hypothesis of this study is that the addition of NovoTTF-100A System treatment to~     salvage chemotherapy will significantly increase time to treatment failure in the brain of~     small cell lung cancer patients.~   "
48284|NCT02425059|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Rectal Neoplasms.~   "
48255|NCT02425436|"~     The use of herbal medicinal products is increasing enormously in recent years, mainly among~     women, who use them for the most varied purposes, such as in menstrual problems, menopausal~     symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to~     the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral,~     antioxidant and antiinflammatory activities, as well as being used in the treatment of~     osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from~     the consumption of flavonoids, little is known about their safety and potentially harmful~     toxic effects, such as mutagenicity and genotoxicity which might occur if taken in large~     doses . Safety of Ginkgo biloba during pregnancy or lactation was not criticized in~     literature. Roasted and raw ginkgo seed were not reported in the evidence-based medicine~     literature as being either safe or contraindicated in pregnancy or lactation. A higher~     incidence of postpartum hemorrhage was reported in the literature when associated with a~     3-month ingestion of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L.~     (Ginkgoaceae), a medicinal plant widely used by the population . G. biloba has its origin in~     China, Korea and Japan where its fruits and leaves have been used as food and medicine for a~     long time.~      The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e.,~     ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols~     . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose~     metabolites were found in the blood of rats and in human urine after oral administration of~     EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used~     in the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular~     insufficiency and peripheral arterial occlusive disease . In folk medicine, EGb is used as a~     vermifuge, to induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains,~     arthritis and edema . The aim of this study was to evaluate the effect of oral~     supplementation of Ginkgo Biloba extract on the fetal weight as well as feto-maternal blood~     flow in cases of intrauterine growth restriction.~   "
48256|NCT02425423|"~     The aim of this study is to evaluate the efficacy of a new thickened formula on~     regurgitation.~   "
48257|NCT02425410|"~     The purpose of this study is to investigate viral factors determining the early onset of~     T1D. Thanks to the quantification of viral exposures of T1D patients before the disease~     onset with questionnaires and environmental databases analyses, and through whole genome~     association studies of these patients, investigators could attempt to identify gene-virus~     interactions determining the age of T1D onset.~   "
48258|NCT02425397|"~     A limited number of relatively contradictory studies have suggested that the development of~     serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be~     partly related to genetic risk factors affecting detoxification enzymes and membrane~     transporters of platinum derivatives. The objective of this study is therefore to identify~     genetic variants associated with the development of platinum ototoxicity in patients treated~     with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following~     diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour,~     osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A~     total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120~     controls with no signs of ototoxicity (separate complete audiograms for each ear) will be~     included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value~     of this study will be to define a population at high risk of developing ototoxicity in order~     to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant~     medications~   "
48259|NCT02425384|"~     The primary objective of this protocol is to test whether an activity monitor with an online~     motivational rewards component will increase physical activity levels of middle school-aged~     students. The secondary objective is to learn about the functionality and utilization of the~     activity meter device among this age group.~   "
48260|NCT02425371|"~     Growing recognition of the importance of co-morbidities in Heart Failure with Preserved~     Ejection Fraction (HFPEF) has led to the realization that rather than being a distinct~     disease entity, HFPEF may represent a spectrum of co-morbidities in elderly breathless~     patients. Accordingly, progress in managing HFPEF in the elderly requires improved~     understanding of HFPEF pathogenesis with a focus on the impact of co-morbidities. However,~     the available evidence is insufficient to determine the true prevalence and severity of~     co-morbidities as well as their impact on both diagnosis and treatment in HFPEF. Therefore~     there are widespread diagnostic uncertainty without proven therapy!~      The purpose of this project is twofold:~        1. The investigators will study how to improve diagnostic accuracy for HFPEF in elderly~          patients, despite frequent comorbidities and higher age? How useful is it to add~          exercise testing and contrast echocardiography as well as biomarker as additional~          diagnostic tools in elderly HFPEF patients?~        2. The investigators will test the hypothesis that HFPEF in the elderly is dominated by~          multiple co-morbidities that are a major part of the syndrome itself that contribute to~          the development of HFPEF. This hypothesis implies that the treatment of co-morbidities~          will improve prognosis.~      The investigators' overall goal is to bring about a paradigm shift in managing elderly~     patients with HFPEF by not only improving diagnosis but also effectively treating~     co-morbidities that are currently considered predisposing factors to HFPEF. This contrasts~     with trials during last two decades that only target the heart.~      The investigators will pursue the following specific aims:~        1. Validate the diagnostic criteria for HFPEF proposed by European Society of Cardiology~          2012, and determine the added diagnostic values of exercise testing and contrast~          echocardiography as well as biomarker for HFPEF in a multi-center study.~        2. Determine if systematic screening and optimal management of co-morbidities associated~          with HFPEF improves the outcomes of patients with HFPEF in a randomized study.~   "
48261|NCT02425358|"~     Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute~     myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary~     intervention (PCI); however, the optimal timing is unknown. The present study assessed the~     therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).~   "
48262|NCT02425345|"~     The WHISH trial applies state-of-the science behavioral principles and currently available~     technologies to deliver a physical activity intervention without face-to-face contact to~     ~25,000 older U.S. women expected to consent. It includes an algorithm-driven interactive~     voice response (IVR) system, built to complement the National Institute of Aging (NIA)~     Go4Life® Exercise & Physical Activity materials 3, which provides tailored advice on how to~     achieve nationally recommended levels of PA and overcome barriers to exercise, with a means~     for self-monitoring and setting personal goals. The intervention builds upon evidence-based~     behavioral science principles and intervention components that have proven to be effective~     in increasing PA in older women, with innovative adaptive approaches to tailoring the~     delivery to meet individual (personal) needs.~   "
48263|NCT02425332|"~     The aim of this study is the validation of a novel gait assessment method implemented in the~     Lokomat gait trainer with respect to established clinical gait assessment methods. The~     walking assessment method is based on the progressive reduction of the support of the~     device. The outcome measures of this algorithm will be the support needed in the different~     gait phases (guidance force of hip and knee joints) and the support required to the body~     weight support system (unloading). The hypothesis is that the guidance force and the support~     of the device will converge to a profile individual for each subject that is representative~     of one's impairment in the different gait phases. The reliability of the method will be~     tested collecting data from two sessions of Lokomat training. The validity of the method~     will be tested comparing the outcome of the assessment task with established clinical~     walking assessment measures.~   "
48265|NCT02425306|"~     This study evaluates whether it is safe to administer a peptide vaccine in combination with~     different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In~     this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study~     will also evaluate the effects of the combination of the peptide vaccine and the adjuvants~     on the immune system. The investigators will monitor these effects by performing tests in~     the laboratory on participants' blood, a lymph node, and tissue from the sites of~     vaccination.~   "
48266|NCT02425293|"~     The aim of this study was to investigate the effect of standardized patient education on~     asthma control. In collaboration with two health insurance companies, pharmacists and~     pneumologists, patients with asthma were recruited. They completed the Asthma Control Test~     (ACT) and the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire to~     assess asthma control and patients' satisfaction with the health care service they received.~     Additionally, patients were offered the possibility to participate in a patient education~     seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year,~     patients were asked to complete the questionnaires again. Comparisons of intraindividual~     changes and differences regarding ACT and PACIC 5A between patients with and without patient~     education were made.~   "
48267|NCT02425280|"~     This study aims to understand how war trauma affects children's and adolescents' memory~     functions and mental health, and whether Narrative Exposure Therapy is effective in~     enhancing optimal memory functions and alleviating mental health problems. The study~     analyzes the mental health and cognitive and emotional healing mechanisms of therapeutic~     intervention among war-affected children and adolescents.~   "
48268|NCT02425267|"~     The main objective of the study is to compare the clinical effects of the innovative~     telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC~     group) for patients treated for a proximal humerus fracture.~   "
48269|NCT02425254|"~     The purpose of this study is to test whether a dose of paracetamol given before surgical~     incision is more effective at reducing postoperative pain and analgesic consumption in~     cervical spine surgery versus a dose given at the end of surgery.~   "
48270|NCT02425241|"~     This is a clinical proof-of-concept (PoC) study of DNA vaccination after SAP depletion. The~     investigators will measure the immune responses to DNA vaccination against HIV-1 in healthy~     adult male volunteers, comparing a group in whom SAP has been completely depleted at the~     time of DNA vaccination and a control group vaccinated without SAP depletion.~   "
48271|NCT02425228|"~     This is a pilot study to determine cancer detection rate of conventional/systematic versus~     targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a~     diagnostic trial using each patient as his own control.~   "
48272|NCT02425215|"~     Background: Radiotherapy is a common treatment for many malignancies. Radiation-related~     complications developing months or years after radiation treatment are known as late~     radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors~     who have received radiation.~      Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the~     studies evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue~     damage and improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on~     pain in LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in~     3 cases of refractory pain in oncological patients with radiation soft tissue injury. Other~     studies showed significant improvement in pain intensity in patients with breast cancer and~     pelvic malignancies treated with HBOT for LTRI. In patients that had developed radiation-~     induced brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a~     reduction in lymphoedema. A prospective case study of 16 patients with gynecological cancer~     found no changes with respect to pain and depression outcomes. A trial in patients with~     radiation induced proctopathy showed that 75% of patients with rectal pain had some~     improvement, although none experienced a complete resolution of pain symptoms.~      There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing~     body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and~     endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph~     (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all~     demonstrated a modification in the pain response following HBOT. In animal studies HBOT~     decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory~     pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in~     non-injured tissues.~      In human studies, HBOT decreased pain and edema and improved function in patients suffering~     from the complex regional pain syndrome, and improved pain scores and range of motion in~     patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis~     demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In~     patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in~     symptoms and these effects were lasting for 6 months following treatment. HBOT was also~     found to be an effective treatment for cluster headaches and migraines and alleviated muscle~     and bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related~     osteonecrosis of the jaw.~      Based on the evidence presented above and HBOT's known analgesic effect in many conditions,~     the investigators designed this study with the objective to evaluate if HBOT reduces pain,~     improves depression and impacts on patients quality of life in patients suffering from late~     radiation tissue injury.~      Study Design: Prospective observational study (n=300). Patients that have had radiation~     therapy for malignancy, developed late radiation injury and suffer from chronic pain.~   "
48273|NCT02425202|"~     The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side~     effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.~   "
48274|NCT02425189|"~     The NLQTS Research Network team aims to build a Canadian collaboration of dedicated~     investigators that will create a new paradigm in the modern investigation of patients with~     LQTS and in the description of a new disease modifier.~      The project aims to describe the natural history of familial Long QT Syndrome to identify:~        1. Low risk patients that do not require protective beta-blocker therapy~        2. High-risk patients that require protective beta-blocker therapy and may benefit from a~          primary prevention ICD. This cohort would contain treated pre-symptomatic individuals~          effectively protected from harm.~   "
48275|NCT02425176|"~     The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied~     and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea~     treatment. This research is aimed to find the dose of Dysport® that would be efficacious~     without treatment-related adverse events and the duration of effectiveness of the drug for~     sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse~     effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24~     weeks post injection in this double-blinding, randomized trial.~   "
48276|NCT02425163|"~     Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and~     Prostate Cancer detection.~   "
48277|NCT02425150|"~     The purpose of this study was to determine whether mechanical compression of the cornea~     during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve~     the optical outcomes of the treatment.~   "
48278|NCT02425137|"~     Primary Objective:~      To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients~     with advanced biliary tract cancer~      Secondary Objectives:~        -  To evaluate overall response rate (ORR)~        -  To evaluate progression-free survival (PFS)~        -  To evaluate overall survival (OS)~        -  To assess the safety profile~   "
48279|NCT02425124|"~     A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care~     clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to~     assess mental health and health outcomes for depressed adults receiving hypertensive~     treatment by measuring the real-world effectiveness of a facility-based stepped care~     intervention combining stress and depression case detection and management by non-physician~     clinicians and referral pathways for anti-depressant medication and/or group/individual~     counselling delivered by lay-health workers for patients with depression. The control~     condition is enhanced usual primary health care where non-physician clinicians have been~     equipped with the basic skills to identify stress and depression/anxiety but with limited~     access to doctors authorized to prescribe antidepressant medication, and with no specific~     psychosocial interventions.~   "
48280|NCT02425111|"~     The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by~     ileocolonoscopy.~   "
48281|NCT02425098|"~     The purpose of this study is to assess the post-vaccination neutralizing antibody response~     against each dengue serotype by treatment arm.~   "
48282|NCT02425085|"~     Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is~     feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled~     eyes of adults over a 3-month observation.~      Here, the investigators conduct this randomized and multicenter clinical trial to compare~     the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.~   "
48285|NCT02425046|"~     Low-income children and children of obese parents are at high risk of obesity. Effective~     interventions are needed to target these families to improve the health of the parents and~     prevent obesity in the children. The hypothesis is that an intervention that combines~     engagement of community organizations, motivational interviewing (MI, a technique proven to~     help people set goals that are personally meaningful), and resource mobilization will change~     diet and physical activity habits among disadvantaged families. This proposal grew from an~     established community-based participatory research (CBPR) partnership between the research~     team and community organizations that serve high minority (45-55%), low-income populations.~     Partners include a community health center, a food pantry network, a work-force training~     program, and other agencies. These partners designed and implemented a successful pilot~     project on which this proposal is based. The specific aims of this proposal are 1) To~     evaluate the efficacy of a family-targeted obesity intervention based on MI and~     resource-mobilization. Hypotheses: In comparison to control families, families participating~     in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in~     minutes of moderate physical activity and decreased sedentary time for both adults and~     children accelerometer), and c) a reduction in the number of obesity risk behaviors and an~     increase in obesity prevention behaviors among children. 2) To examine the mediators of~     intervention effects. 3) Identify the types of resources needed most often by intervention~     families to support lifestyle change. This randomized controlled trial includes 260~     low-income families that contain at least one obese adult and one normal or overweight child~     between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI~     to help families explore ambivalence toward and motivations for change and set goals for~     improving diet and physical activity. 2) To support goals, families will be connected with~     community agencies that can assist with general (e.g., financial) and goal specific~     resources (e.g., food, physical activity opportunities). Collaboration between organizations~     will streamline referrals, maximize resources, and facilitate access. Control families will~     get a basic screen for needs and information about available community resources. Outcomes~     are measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it~     1) focuses on lifestyle changes for the entire family and measures outcomes in adults and~     children, 2) combines MI focused on the entire family and community resource referrals~     specific to family needs and goals for change, 3) partners community organizations to~     coordinate resources for families, and 4) involves partners in all research phases via a~     CBPR approach. This contribution will be significant because the proposed intervention, if~     successful, can be replicated elsewhere and adapted to the local resource environment to~     address adult obesity and prevent childhood obesity in a high-risk population. The study~     will also identify the types of resources low-income families need to change diet and~     physical activity.~   "
48286|NCT02425033|"~     This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM)~     technique for lower esophageal sphincter myotomy in patients suffering from spastic~     esophageal disorders such as achalasia at a Canadian institution.~      The investigators hypothesize that POEM is a safe and effective technique for the surgical~     management of such disorders at our institution.~   "
48287|NCT02425020|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     meat hydrolysates extract with a regular resistance training programme on (a) body~     composition (b) performance (c) muscle structure (d) general markers health and immunity in~     athletes. As a second objective the investigators will analyse potential differences~     obtained from the ingestion of the new hydrolysates meat protein extract compared to the~     ingestion of others commercially available protein sources such as whey or casein.~   "
48288|NCT02425007|"~     The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly.~     Outcomes are lung function and chest expansion.~   "
48289|NCT02424994|"~     The aim of this project is to study the association of a number of demographic and~     cardiovascular risk factors with death, health care utilisation and systemic embolisation by~     examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based~     cohort identified from linked electronic health records.~   "
48290|NCT02424981|"~     Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function,~     muscle strength and chest expansion.~   "
48291|NCT02424968|"~     This phase II trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work~     as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant~     in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and~     anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth~     of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells (called graft-versus-host disease). Giving cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening. Once the donated~     stem cells begin working, the patient's immune system may see the remaining cancer cells as~     not belonging in the patient's body and destroy them. Giving an infusion of the donor's~     white blood cells, such as CD8+ memory T-cells, may boost this effect and may be an~     effective treatment to kill any cancer cells that may be left in the body (consolidative~     therapy).~   "
48292|NCT02424955|"~     Primary Objective:~      The primary objectives of this prospective pilot study is to:~        1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound~          imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and~        2. evaluate whether there are treatment induced early changes in imaging metrics derived~          from 3D contrast enhanced ultrasound. This study will provide valuable insight as to~          the potential of baseline and/or early post-treatment 3D ultrasound perfusion~          characteristics (measurements of blood-flow) of primary and metastatic liver tumors to~          predict tumor response to Stereotactic Ablative Radiotherapy. The investigators'~          underlying goal is to assess whether early perfusion changes at 1-7 days after SABR~          initiation can be used as a non-invasive early biomarker for treatment response~          assessment.~      Secondary Objectives:~      Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting~     three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic~     tracking of the ultrasound probe on patients with liver cancer that will undergo CT for~     treatment planning and/or response evaluation.~   "
48293|NCT02424942|"~     Primary Objective:~      To assess the safety and tolerability of ascending single intraarticular doses of GZ389988~     in patients with painful osteoarthritis (OA) of the knee.~      Secondary Objectives:~      To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of~     GZ389988 in patients with painful OA of the knee.~      To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of~     GZ389988 in patients with painful OA of the knee.~   "
48304|NCT02424799|"~     This First Time in Human (FTIH) study, which will be performed in three parts, is designed~     to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after~     single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding~     placebo within the same subject, in healthy adult subjects (Part A), subjects with cold~     urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The~     study will also measure short term effects of GSK2646264 on the number and size of weals in~     subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.~   "
48294|NCT02424929|"~     The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS)~     surgery in patients who are deeply sedated, asleep, or not sedated, awake, during~     surgical implantation of the DBS electrode. The investigators hypothesize that the clinical~     outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3~     specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep~     and awake groups using microelectrode recording, to see how this affects clinical~     outcomecapability of microelectrode recordings and macrostimulation to identify the~     subthalamic nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS~     electrode is sufficient for accurate DBS electrode placement. 3) Compare the clinical~     outcome on their Parkinson's disease between awake and asleep DBS patients.~   "
48295|NCT02424916|"~     This study evaluates the safety as well as the potential clinical efficacy of an adoptive~     transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and~     MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages~     IIIc and IV).~   "
48296|NCT02424903|"~     The purpose of the study is to compare different approaches for the treatment of prosthetic~     joint revisions and to optimize the outcomes in patients with prosthetic joint infections~     (PJI) by improving the treatment concept of PJI.~   "
48297|NCT02424890|"~     The objective of this randomized trial is to study the effect of stress on performance and~     the effect of repetition of simulation sessions on performance and stress. This study is a~     randomized controlled trial including 48 participants who composed 12 multidisciplinary~     teams (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a~     nurse, and an ambulance driver who usually compose an emergency team of the French Emergency~     Medical Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm~     Group). 6 MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the~     existence of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and~     psychological stress questionnaires. The impact of stress on overall team performance, on~     technical procedure, and on teamwork, is evaluated by specific validated scales. Detection~     of post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one~     month. The perspective is to concomitantly evaluate technical and non-technical performance,~     and the impact of stress on both. This is the first randomized trial studying repetition of~     simulation sessions and its impact on both clinical performance and stress as explored by~     objective and subjective assessments. The investigators expect that stress decreases team~     performance and that repeated simulation increases team performance. The investigators~     expect no variation of stress parameters regardless of level of performance.~   "
48298|NCT02424877|"~     The purpose of this study is to determine whether automated remote monitoring of patients~     with early rheumatoid arthritis by the SandRA software and short message service of cell~     phones increases patient compliance and helps to identify patients needing re-assessment of~     medication before scheduled visits. This might result in better clinical outcome and~     cost-effectiveness.~   "
48299|NCT02424864|"~     FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ~     motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph~     nodes. The investigators hypothesize that the metabolic signal obtained with motion~     compensation results in higher SUV-max values and clearer demarcation of the esophageal~     tumor and lymph nodes.~   "
48300|NCT02424851|"~     The purpose of this study is to compare the effectiveness of bortezomib versus thalidomide~     in reducing free light chains in the blood of myeloma patients. In addition participants~     will receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the~     effectiveness of both bortezomib and thalidomide. The trial will also study whether an~     earlier reduction of free light chains increases the chances of the kidneys recovering.~   "
48301|NCT02424838|"~     After patients have been screened and have signed informed consent, they will be taken to~     the endoscopy suite. Once the decision has been made to proceed with FNA, the subject will~     be randomized to 1 of 4 groups:~        -  22gauge (G) needle with suction~        -  25G needle with suction~        -  22G needle without suction~        -  25G needle without suction~      Follow-up Phone Call Phase:~      Unit staff will call patients 1 week after the procedure to check if patients had any~     adverse events from the procedure and this will be recorded onto the dataset.~   "
48302|NCT02424825|"~     The purpose of this protocol is to collect data from approximately 15 multiple sclerosis~     (MS) patients who are participating in a pilot cooking course. This online cooking training~     program is currently available to general public through the company Rouxbe for a fee.~     Data gathered from this cooking course will be used to develop novel ways of promoting~     healthy eating habits in people with MS. The investigators will use the data from blood~     tests, questionnaires, and demographics to assess the feasibility and effectiveness of this~     program. This is an outpatient program designed for people with MS that would occur~     regardless of whether participant data is collected.~      This pilot cooking course will run for approximately four weeks. The investigators intend~     start to the training course in mid-March 2015. Subjects will be followed prior to course~     initiation for baseline data gathering, at four weeks from baseline, twelve weeks from~     baseline, and twenty-four weeks from baseline.~   "
48303|NCT02424812|"~     The effect of large scale handwashing and hygiene promotion campaigns on handwashing~     behaviour, diarrhoea and respiratory infections is not known. While Intensive small scale~     interventions have achieved improvements in handwashing behaviour and reductions in~     diarrhoea and respiratory infections, it is not clear whether realistic and scalable~     interventions delivered across large areas achieve effects large enough to be of public~     health interest. The Unilever School of 5 Lifebuoy campaign is such a scalable~     intervention that is being rolled out across the state of Bihar during 2015 to 2017. The~     proposed study aims at evaluation the effect of this campaign on handwashing behaviour in~     school aged children and their mothers, and on diarrhoea and respiratory infections in the~     same children and their younger siblings.~   "
48432|NCT02423122|"~     This study will assess the effects of administration of VX-745 for 12 weeks on amyloid~     plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo~     11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at~     baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted~     at baseline and day 45.~   "
48305|NCT02424786|"~     The study aims to investigate adherence and polypharmacy in elderly patients with chronic~     kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into~     possible factors or predictors that may affect adherence and reduce polypharmacy. Factors~     could be: quality of life, anxiety and depression, beliefs about medicine and cognitive~     impairment.~      The investigators are planning an intervention with the screening tool Screening Tool of~     Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right~     Treatment (STOPP/START ) criteria to evaluate medication lists of the participating~     patients.~   "
48306|NCT02424773|"~     In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high~     case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the~     most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has~     been reported as an alternative to the venturi mask. The aim of this study is to compare~     HFNC and venturi mask on early respiratory deterioration and patient's comfort in that~     setting. The investigators planned a prospective randomized study in 4 Intensive Care Units~     (ICUs). As respiratory deterioration occurs early after ICU admission, patients are~     randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The~     primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period.~     Secondary endpoints include comfort, dyspnea and thirst.~   "
48307|NCT02424760|"~     The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a~     Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve~     severe pain or significant disability caused by degenerative pathologies. The rotator cuff~     must be functional.~      The aim of this study is to prospectively collect data from consecutive series to implement~     a Post Marketing Surveillance plan.~   "
48308|NCT02424747|"~     The study evaluates how outcome varies among critically ill patients with and without acute~     kidney injury. Data from the Swedish Intensive care register and other Swedish national~     registers is used to compare how survival and post discharge renal function differ between~     critically ill patients with and without acute kidney injury.~   "
48309|NCT02424734|"~     The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the~     treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days.~   "
48310|NCT02424721|"~     To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the~     evaluation of patients admitting to the emergency department with suspected infection.~   "
48311|NCT02424708|"~     Glutathione is an important nutrient for brain function and loss of glutathione has been~     implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of~     three amino acids, the nutrients that make up protein. This study will determine whether~     administration of either dose of glutathione, as a nasal spray, improves PD symptoms over~     time in a population of individuals with Parkinson's disease (PD).~   "
48312|NCT02424695|"~     This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess~     objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG~     responsivity in patients with RLS. The study will include 8 visits over a period of up to 8~     weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week~     placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be~     administered within 1 to 3 weeks after Screening/Washout. The total duration of the study~     from the first subject enrolled to the last subject completed will be approximately 1 year.~   "
48313|NCT02424682|"~     This study was designed to evaluate safety and tolerability of Herceptin as treatment for~     patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast~     cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse~     events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2~     positive metastatic breast cancer.~   "
48314|NCT02424669|"~     Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is~     considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in~     mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that~     leads irrevocably to death within 2 or 5 years of clinical onset.~      Since there is no cure for ALS, the management of the disease is supportive and palliative.~     Riluzole is the only drug that has been shown to extend survival by about three months. The~     identification of biomarkers sensitive to the progression of the disease might enhance the~     diagnostic and provide new drug targets.~      Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of~     interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS~     patients. However, the cell origin as well as the pathogenic influence of this peripheral~     source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS~     and might be a potential biomarker of the disease.~   "
48315|NCT02424656|"~     This study explores the changes in whole-brain connectivity that occur during recovery from~     severe Traumatic Brain Injury and how these changes are related to the recovery of~     consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion~     while patients are undergoing neurorehabilitation and after one-year of the TBI episode.~   "
48316|NCT02424643|"~     The purpose of this study is to test the efficacy of alternative methods to improve survey~     completion.~   "
48317|NCT02424630|"~     The investigators compared the results of sono-guided interscalene brachial plexus block~     (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB~     alone within the first 48 h after arthroscopic rotator cuff repair.~   "
48318|NCT02424617|"~     A Phase I/2 multi-center open-label study of BGB324 in combination with erlotinib in~     patients with Stage IIIb or Stage IV non-small cell lung cancer.~   "
48319|NCT02424604|"~     Aim The overall aim with this study is to improve outcome after inguinal hernia repair~     (IHR). It is not known today if a re-operation due to recurrence after bi-layer mesh IHR is~     more complicated than compared with the golden standard method.~      Method This project is a registry study. The National hernia register (Svenskt~     bråckregister, SBR) which started in 1992 include data that cover nearly 100% of all the~     country's hernia operations.~      Patient data are collected from SBR. Patients who at the time of surgery were between 18-75~     years of age and operated on due to primary inguinal hernia with any of the two mentioned~     techniques between 1992-2012 are eligible~   "
48320|NCT02424591|"~     Postoperative pain is severe after major spine surgery. Opioids such as morphine and~     hydromorphone are routinely used for postoperative pain control. These drugs have~     significant side effects, most importantly respiratory depression, nausea, constipation and~     tolerance. Moreover, many spine surgery patients have used opioid pain medication for back~     pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain.~     This has led to a search for adjuvant medications to reduce the use of opioids and reduce~     opioid mediated side effects and tolerance.~      Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses.~     Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA~     receptors are involved in central pain sensitization via wind-up phenomenon and altered pain~     memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent~     the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to~     decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of~     administration.~      Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life~     of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause~     respiratory depression.~   "
48321|NCT02424578|"~     The purposes of this study are to evaluate the safety and tolerability and to model the~     single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in~     children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.~   "
48322|NCT02424565|"~     The rationale of this study is to map out changes in temperature distribution brought about~     by topical application of our test product, and use this physiological phenomenon to~     visualize the onset of action involved in overall mechanism of action of the product.~   "
48323|NCT02424552|"~     The purpose of the EVITA trial is to compare the effects of vitamin D therapy with placebo~     on reducing the dose of inhaled or oral corticosteroids in patients with severe asthma and~     vitamin D insufficiency.~   "
48324|NCT02424539|"~     This Phase IV interventional study is a multi-center, randomized, double-blind,~     placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55~     mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages~     2 to 12 years with AR.~      This study comprises screening and run-in period (4 to14 days), double-blind treatment~     period (28 days) and follows up period (3 to7 days). Subjects entering the study will~     participate for maximum of 50 days, including five clinical visits and a follow-up contact.~      The study is planned to enroll approximately 360 subjects.~   "
48325|NCT02424526|"~     This study is designed to find the optimal dosage of home-based treadmill training needed to~     accelerate walking onset and to examine the long-term effects on the child's walking~     activity.~   "
48326|NCT02424513|"~     This is a prospective, multicenter, open-label, non-randomized study evaluating the ability~     of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by~     pathology.~   "
48327|NCT02424487|"~     The purpose of this study is to evaluate the initial pressure and changes of the intracuff~     pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.~   "
48328|NCT02424474|"~     The purpose of this study is to evaluate the performance of non invasive screening in a~     population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to~     regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold~     measurement and serum screening.~   "
48329|NCT02424461|"~     This study will investigate the treatment of urinary tract infection (UTI) in men. The~     investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior~     to a longer duration of antibiotics (14 days). The investigators will also study whether~     longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota~     or an increase in drug side effects.~   "
48330|NCT02424448|"~     This is a biopsy feasibility study in which patients with castration resistant prostate~     cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival~     and de novo), blood samples, a urine specimen and clinical data for research.~   "
48331|NCT02424435|"~     This study will explore whether methylprednisolone treatment is safe, well-tolerated, and~     beneficial in patients that are diagnosed with Friedreich Ataxia (FRDA). The study will also~     explore if methylprednisolone has any effects on biomarkers associated with FRDA. All~     subjects in the study will receive the same steroid treatment.~   "
48332|NCT02424422|"~     The aim of this study to test the immediate effect of rapid maxillary expansion on~     craniofacial sutures in children using cone beam computed tomography.~      Materials and Methods: Subjects consisted of 15 growing patients between the ages of 8 and~     12 with Skeletal transverse maxillary deficiency with unilateral or bilateral posterior~     cross bite.~      All patients will be treated with A bonded Hyrax (a rapid palatal expander with an acrylic~     occlusal splint). The planned activation protocol consisted of 2 turns per day (0.25 mm per~     turn) until the resolution of posterior cross bite with 2 to 3 mm overcorrection of~     expansion then tying off the jackscrew with a ligature wire and placing a smooth composite~     material over it. The initial CBCT scan (T0) will be taken before cementation of the~     maxillary expander and again immediately after the end of the active expansion (T1). First,~     all CBCT images will be oriented then the craniofacial sutures(Intermaxillary Suture,~     Midpalatal Suture, Transpalatal Suture, Internasal Suture, Frontonasal suture,~     Zygomaticotemporal suture, Frontomaxillary suture, Zygomaticomaxillary suture, Nasomaxillary~     sutures, Spheno-occipital synchondrosis) will be examined. Where the linear measurements~     will be carried out directly on the CBCT image using the OnDemand 3D Imaging software~     program.~   "
48355|NCT02424123|"~     Seizures represent an important clinical problem, accounting for at least 40% of adult onset~     epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is~     difficult due to the lack of prognostic biomarkers. Recent evidence has indicated that~     blood-brain barrier (BBB) dysfunction constitutes an etiological factor to seizures. In~     particular, it has been shown that modification of BBB permeability is associated with~     seizure activity. In addition, it was demonstrated that BBB permeability can be assessed by~     measuring serum level of the protein S100B. Based on these data and considerations the~     investigators will test whether the extent of BBB damage at time of first seizure is~     predictive for seizure recurrence.~      The main objective of this study is to evaluate the association between the absolute (ng/ml)~     serum S100B levels (measured at time of the first seizure) and the experience, or not, of~     seizure recurrence within one year of follow-up.~   "
48333|NCT02424409|"~     For over ten years, the French group ASUR (ASthme aux URgences) has studied the asthmatic~     disease. The first epidemiological study enrolling 3.772 patients, in 37 emergency services,~     showed that the treatment protocols during the acute asthma attacks were not homogeneous and~     that oral corticosteroids were prescribed in only 50% of the cases. The second major French~     study in the emergency department by the same group enrolled 3.049 patients. The results~     showed that 38% of patients have a new acute asthma relapse in the month following their~     consultation in the emergency department. In the same study, a multivariate analysis of~     predictors of relapse showed that there are controllable factors (absence of written~     recommendations at discharge, only 50% of prescriptions for oral corticosteroids at~     discharge from the emergency department, limited follow-up by a general practitioner (GP) or~     pneumologist ...).~      The emergency physician has a responsibility in educating the patient during the period~     between an acute asthma attack and return to the stability of long term therapy. To date,~     the impact of patient education on the rate of further consultations in the emergency~     department has not been proven, although it seems to be a positive trend on its effect. In~     France, half of the patients coming to the emergency department for asthma attack will not~     be hospitalized. More than a third will return to the ED within the first 30 days for a new~     attack. The impact of post-interventional education on relapse should be explored. A first~     major study on a strict formalized protocol designed to reduce the relapse rate is essential~     and could allow a major improvement.~      Our main objective is to assess the impact of a strict formalized protocol of care of~     asthmatic patients discharged from the Emergency Department on the recurrence rate of asthma~     attacks, one month after an asthma attack.~      The expected benefit for the patient is the short-term reduction of relapse after asthma~     exacerbations, thus avoiding the problems of readmission. The strict formalized discharge~     protocol would also improve education in terms of self-medication in this gray zone of~     post-therapeutic monitoring. The benefit is even more important in terms of public health~     due to the important prevalence of asthma in the world and in our country. The advantage of~     this protocol is to strengthen the links between the hospital and the GPs. Education of~     asthmatic patients is essential in reducing morbidity. Thus, the potential benefits of this~     protocol are: reducing the cost of health and re-hospitalization, improved education of~     asthma patients, strengthening their link with the required GP, decreased absenteeism~     usually frequent in this type of disease in the workplace.~   "
48334|NCT02424396|"~     Interleukin‐2 (IL‐2) was initially discovered and used as a stimulator of effector T~     lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the~     capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff~     balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced~     proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose~     IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to~     stimulate Treg and define potential clinical benefits~   "
48335|NCT02424383|"~     The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB~     PTA Catheter in a heterogeneous patient population in a real world and on-label clinical~     application.~   "
48336|NCT02424370|"~     Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat~     symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve~     replacement, it is still restricted to high surgical risk patient who are frail. The aim of~     the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and~     functional recovery after TAVR~   "
48337|NCT02424357|"~     1. To establish the culture positivity rate in adjustable suture strabismus surgery~        2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms~          cultured from suture material~        3. To compare suture contamination rates with techniques to reduce the suture~          contamination rate~   "
48338|NCT02424344|"~     The present study is planned to evaluate the effect of the aclidinium bromide/formoterol~     fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity~     in patients with moderate to severe COPD. Additionally, the effect of the behavioural~     intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed~     both on the exercise endurance and the physical activity.~   "
48339|NCT02424331|"~     This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility,~     the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise~     tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study~     randomized cross-over clinical trial and blind, in subjects with Chronic Obstructive~     Pulmonary Disease (COPD) according to criteria of the Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the~     Clinical Hospital of the Federal University of Pernambuco (UFPE) and Otavio de Freitas~     General Hospital (HGOF). The investigators recruited 13 patients COPD (according to previous~     sample calculation) aged between 40 and 80 years, of both sexes. The first day was held~     evaluation of lung function, respiratory muscle strength, body composition, dyspnea index~     and functional capacity. On the second day was held evaluation of thoracoabdominal complex~     kinematics by plethysmography Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips~     breathing (PLB). Lung volumes with 2 minutes with QB and 6 minutes PLB or only 6 minutes by~     QB as randomization were observed. Before and after performing the requested breathing~     pattern diaphragmatic mobility was observed by Ultrasonography (US) and requested the~     patient an Inspiratory Capacity maneuver (IC). The evaluator who performed the ultrasound~     was blinded as to the beginning of the breathing pattern of order performed by the patient.~   "
48340|NCT02424318|"~     The purpose of this study is to evaluate the effect of topiramate on cerebrovascular~     reactivity and mean flow velocity to photic stimulation in migraineurs.~   "
48341|NCT02424305|"~     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel~     groups will be enrolled. The trial includes three active treatment groups. To be eligible~     for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and~     discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area~     of approximately 250 cm2 of sun-damaged skin.~      There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the~     full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the~     arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once~     daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.~   "
48356|NCT02424110|"~     The objective of the study is to make up the technique blind spots of the bipolar~     radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic~     heart disease by using argon beam coagulator. And to improve the rates of cardioversion of~     atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial~     fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency~     ablation and bipolar radiofrequency plus argon beam coagulator ablation.~   "
48523|NCT02421926|"~     This study is an extension study (prospective observational study) of 'IDEAL' study (A Study~     to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular~     Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase,~     NCT02204722) to evaluate the duration of treatment response, disease progression, and~     survival status up to 5 years after the inclusion.~   "
48342|NCT02424292|"~     Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated~     average survival rates of 73% and five year survival rates of 89% in developed countries.~     However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a~     worse breast cancer related and overall survival, as compared to their normal weight~     counterparts. In addition, weight gain after diagnosis might be negatively associated with~     prognosis.~      Weight gain is a common phenomenon among breast cancer patients receiving adjuvant~     chemotherapy as well as receiving adjuvant anti-hormonal therapy. While sufficient physical~     activity and limitation of the amount of weight gain is important for all breast cancer~     patients, it surely is for overweight and obese patients. The recently published national~     guideline oncological rehabilitation provides exercise goals, for physical training based on~     the Dutch PA guideline Nederlandse Norm Gezond Bewegen (NNGB). It recommends to engage in~     moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least~     5 days a week. For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended~     to exercise at least 60 minutes at a moderate-intensity level, equal or more than 3~     Metabolic Equivalent Task Hours (> 3 MET/h), on at least 5 days a week. However, only 61% of~     the general population, meets these guidelines (8) and among cancer patients this percentage~     is even less. This study aims to increase the percentage of overweight breast cancer~     patients treated with adjuvant anti-hormonal therapy that reaches the goal of the NNGB by~     the oncological rehabilitation program with 20%.~   "
48343|NCT02424279|"~     Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is~     made usually in the late stage of this condition. One of the treatment methods of pain~     accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a~     safe procedure with a small percentage of complications, nevertheless it is often use as the~     last stage in pain management what significantly decreases its effectiveness.~      The aim of this study is to determinate the effect of invasive pain treatment~     (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception~     at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT~     questionnaires), and suffering (measured with PRISM projection test), the use of painkillers~     during the disease and patients' overall survival. Moreover the investigators want to check~     if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is~     combined with better therapeutic effect of this treatment.~   "
48344|NCT02424266|"~     The purpose of this study is to investigate the ability of an imaging device, developed by~     AdOM Advanced Optical Technologies Ltd. (AdOM). The device allows a three-dimensional~     imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The~     device is based on the use of white light.~      In this initial study, the device will be used to assess the tear film which coats the~     corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis~     Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal~     layers will be evaluated in the second phase of the study.~   "
48345|NCT02424253|"~     This will be a randomized, double blind, placebo controlled, parallel group study in~     approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12~     and ≤ 48 (0-72 scale). Following a run-in subjects will be randomized to receive either oral~     30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).~   "
48346|NCT02424240|"~     A 35-month cross-sectional observational study was conducted at an outpatient university~     hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for~     134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial~     growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7~     ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance~     tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.~   "
48347|NCT02424227|"~     This is a prospective, multicenter, observational study of kidney transplant subjects where~     blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn~     after transplant~   "
48348|NCT02424214|"~     Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality~     Oocytes and Teratozoospermia patients.~   "
48349|NCT02424201|"~     Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active~     management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage.~     Hence the need for an effective oxytocic in third stage of labour.~   "
48350|NCT02424188|"~     This study will determine whether an 18-month practical tobacco smoking cessation program~     integrating weight management counseling and exercise will be superior to treatment as usual~     in achieving prolonged smoking abstinence in persons with serious mental illness.~   "
48351|NCT02424175|"~     This is an open-label single-arm pilot study to measure the microbiological and clinical~     impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing~     Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2~     who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will~     be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides~     hospitals with screened, filtered, and frozen material ready for clinical use~   "
48352|NCT02424162|"~     This study will compare cataract patients with implantation of diffractive multifocal IOL~     with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2).~     Evaluations will be performed 1 and 3 months following cataract surgery, including~     measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest~     refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3~     months, internal aberrations and contrast sensitivity will be evaluated and subjects will~     complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.~   "
48353|NCT02424149|"~     In this prospective, randomized trial subjects will be randomized to receive phenazopyridine~     or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm~     ureteral patency intraoperatively.~   "
48354|NCT02424136|"~     Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy~     have high sensitivity, but not high specificity. This clinical trial will test the validity~     of a novel blood biomarker (compared with current testing) as a diagnostic predictor of~     anaphylaxis to peanut.~   "
48357|NCT02424097|"~     The objective of this clinical study is to evaluate the efficacy of multiple applications of~     MI Varnish in combination with MI Paste Plus in caries protection and remineralization in~     comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse~     recommendation) in orthodontic patients in a randomized, single blind, prospective,~     controlled clinical trial over 12 months.~      The effect will be measured by white spot lesion regression and prevention as lesion count.~     Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme~     (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries~     lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and~     Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE~     fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior~     teeth with orthodontic brackets in treatment and control groups.~   "
48358|NCT02424084|"~     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim~     at replacing pseudarthrosis by well vascularized bone and improving microcirculation.~     Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can~     accelerate bone healing in case of non-union, only a few studies focused on the elucidation~     of its mechanisms of action. Therefore, the aim of this study is to evaluate the~     microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and~     metacarpal and metatarsal in a human in-vivo setting for the first time.~   "
48359|NCT02424071|"~     Melatonin has sedative, hypnotic, analgesic, antiinflammatory, and chronobiologic properties~     that make it a good premedication agent before anesthesia and surgery. Patients undergoing~     surgery in our establishment usually receive benzodiazepines as premedicants to reduce~     anxiety before the surgery. For bariatric patients benzodiazepines are usually avoided due~     to side effects which could be deleterious in obese patients.~      In this study the investigators intend to randomise 60 patients undergoing bariatric surgery~     into two groups. The participants will receive either melatonin or placebo on the evening~     prior to the surgery, and the same agent two hours before the surgery.~      The patients recovery from the surgery and anesthesia will be assessed using the Q0R15~     questionnaire. The patients will be asked to take the questionnaire once in the~     pre-operative clinic, again after the second melatonin or placebo pill before entering the~     operating room, and once more on the first post-operative day.~   "
48360|NCT02424058|"~     The purpose of this study is to investigate the sagittal thoracic spinal curvature and~     mobility in subjects with and without chronic neck pain, cut-off points and pain~     relationship~   "
48361|NCT02424045|"~     BCD (Bendamustine, carboplatin and dexamethasone)chemotherapy regimen is proposed as the~     salvage treatment for relapsed or refractory PTCLs in this study protocol, which would be~     expected to show more promising clinical outcomes than that of bendamustine single therapy.~     Platinum combination with bendamustine is a theoretically ideal salvage regimen for the~     patients of PTCLs because these both agents are highly effective drugs in lymphoma treatment~     and have rare cross-resistance. Carboplatin was selected as a platinum agent for combination~     with bendamustine, which is a second generation platinum agent and has a less neurotoxicity~     than that of cisplatin, considering use for previously treated patients with vinc alkaloid~     agents.~      In a prior phase I study of carboplatin in combination with bendamustine for previously~     untreated small cell lung cancer patients, the recommended dose for phase II studies was~     bendamustine 100 mg/m2 on day 1 and 2, carboplatin AUC 5 on day 1, respectively [16]. In~     consideration of previously treated subjects, however, the dose of bendamustine was decided~     on 80mg/m2 in this study protocol with concerning about the toxicities, especially to severe~     cytopenia.~      Dexamethasone is one of the corticosteroids using a key drug for lymphoid malignancy and has~     a strong antiemetic effect. Therefore, dexamethasone could enhance the therapeutic efficacy~     and antiemetic effect, using with bendamustine and carboplatin.~   "
48362|NCT02424032|"~     The aim of this study was to investigate and compared the effects of cervical and~     scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for~     patients with chronic mechanical neck pain.~   "
48363|NCT02424019|"~     This study will assess the safety in patients treated with ILUVIEN, with primary focus on~     IOP.~   "
48364|NCT02424006|"~     In this study safety and effectiveness of bioengineered cornea comprising of~     interpenetrating networks of recombinant human type III collagen and synthetic phospholipid~     - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after~     infection, trauma or keratoconus. Control group will consist of patients with the same~     condition who will undergo corneal transplantation - current standard of care.~   "
48365|NCT02423993|"~     The purpose of this study is to assess the effectiveness of structured group education on~     glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin~     infusions (CSII).~   "
48366|NCT02423980|"~     This is an open-label, exploratory pilot study in patients with T1D. The study will involve~     two daytime clinical research center visits 7-14 days apart. Subjects will receive a single~     injection of G-Pen™ (glucagon injection) at each visit.~   "
48377|NCT02423837|"~     -  To evaluate the efficacy of bendamustine in combination with rituximab as first line in~          patients with follicular lymphoma, 1-3A cytological type.~        -  To evaluate the safety, tolerability and feasibility of bendamustine in combination~          with rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type.~        -  To evaluate the impact of the regimen modification (bendamustine dose modification~          and/or extension of inter-cycle interval) into duration of complete and partial~          responses.~        -  To evaluate estimated treatment duration, reasons of treatment withdrawal.~        -  To evaluate the possibility of unification and standardization of therapy protocol BR~          (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2).~        -  To evaluate factors affecting overall and progression-free survival.~   "
48524|NCT02421913|"~     Background: The use of low-dose continuous infusion of S(+)-ketamine combined with~     target-controlled intravenous anesthesia with remifentanil and propofol may be related to~     the control of postoperative pain and of opioid-induced hyperalgesia. The present study~     aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given~     intraoperatively in the control of postoperative pain compared to placebo.~   "
48367|NCT02423967|"~     The primary goal of this study will be to assess whether stool collected and frozen from~     anonymous screened unrelated donors can be as effective as stool freshly collected from~     recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent~     Clostridium difficile infections in children. In the current protocols, which are more than~     90% effective, each child who is receiving a fecal transplant has to provide their own donor~     stool, usually from a parent or close relative. This requires considerable screening costs~     for each case and is logistically complicated as the donor must be present and must stool~     just prior to the transplant. The investigators hope to show that a small number of healthy~     donors can provide stool samples which can be frozen and banked and then thawed for use in~     numerous patients. The primary goal is to show that Clostridium difficile will be eradicated~     as effectively (Greater than 90% success) when using the stool from the frozen donors.~      The study will also evaluate the inflammatory response and intestinal microbiome in young~     children aged 1-3 years with Clostridium difficile infections to better predict which ones~     will respond to fecal transplantation and which ones have incidental infections. For this~     question the investigators will gather stool samples to check for lactoferrin, calprotectin,~     and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal~     transplants. The goal is to see if there is an intestinal microbiome that predisposes some~     children to getting sick from Clostridium difficile versus just having it incidentally.~   "
48368|NCT02423954|"~     Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab~     in subjects with advanced cancer.~   "
48369|NCT02423941|"~     To evaluate whether retrograde caval reperfusion of liver graft could be superior over~     antegrade portal reperfusion in regard of incidence and severity of early allograft liver~     dysfunction.~      All eligible enrolled liver transplant candidates will be randomized to receive either:~        1. retrograde caval, followed by sequential portal-arterial, reperfusion or~        2. antegrade, sequential portal-arterial reperfusion.~   "
48370|NCT02423928|"~     20 patients with invasive castration resistant prostate cancer and radiologically verified~     metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell~     based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and~     elutriation and stimulation by cytokines. The induced dendritic cells will have to pass~     viability, immunophenotyping and sterility criteria and will be injected into a cryoablated~     region of the primary prostate cancer tumor. The treatment is supplemented by~     immunomodulatory regimens.~   "
48371|NCT02423915|"~     T-cells are white blood cells that are important to the immune system. The T cells for this~     study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you.~     Before the Tregs are given to you, they may be changed in the laboratory to make use of~     sugar that is found in small amounts in blood cells through a process called fucosylation.~     They are then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is~     designed to help the Tregs find their way faster to the bone marrow, which may help low~     blood counts to recover faster.~      The goal of this clinical research study is to learn if it is safe and practical to give~     fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched~     unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these~     Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result~     from a reaction of the transplanted cord blood cells against certain tissues in the body.~   "
48372|NCT02423902|"~     This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary~     efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer~     and pre-study SD or PR after completion of a minimum 12 week course of standard first- or~     second-line chemotherapy. The patient population will include patients with locally advanced~     or metastatic breast cancer of all subtypes.~   "
48373|NCT02423889|"~     This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and~     late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All~     participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per~     fraction.~   "
48374|NCT02423876|"~     This randomized clinical trial studies epidural anesthesia within an enhanced recovery~     pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural~     analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and~     stops the feeling of pain. It stays in place for several days after surgery and may be~     helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of~     specific steps used before, during, and after surgery by health care providers to care for~     patients after surgery. ERPs include patient education, not using laxatives before surgery,~     increasing activity after surgery, and scheduled use of medications for pain and nausea.~     Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing~     gynecologic surgery.~   "
48375|NCT02423863|"~     The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus~     intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and~     carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with advanced~     accessible solid tumors~   "
48376|NCT02423850|"~     Diabetic foot ulcers and venous leg ulcers constitute an increasing health problem in~     Denmark concurrent with an ageing population and an increase in diabetes prevalence.~     Diabetic foot ulcers belong to the most serious and costly complications. Several studies~     have found that the size and depth of the ulcer is one of the major etiologic factors for~     delayed healing. Wound measurement is important in the monitoring of the wound healing~     process. For the last decade different 3D techniques for measuring ulcers have been proposed~     in order to measure ulcer volume, but none of the technologies have been widely used. A 3D~     photo-optical camera has been developed, which is able to measure ulcer area and volume.~      The investigators hypothesize that volumetric measurements of diabetic foot ulcers and~     venous leg ulcers are feasible in the assessment of ulcer healing. A prospective cohort~     study is conducted in which newly admitted patients with a diabetic foot ulcer or venous leg~     ulcer are included at the first visit at the polyclinic. The patients are followed for one~     year or until complete ulcer healing, amputation or death. Ulcer area and volume are~     measured by the 3D camera with frequent intervals. Patient anthropometrics and ulcer data~     are collected during the study and correlated to the ulcer healing.~   "
48378|NCT02423824|"~     Cognitive deficits are a core feature across disparate brain disorders, being highly~     prevalent and pervasive. Impairments in executive function are one of the most consistent~     findings in clinical and meta-analytical studies and were reported to be a principal~     mediator of psychosocial impairment and disability. Cognitive dysfunction is thought to be~     underlied by abnormalities in distributed brain circuits, at the cellular and molecular~     levels. Nonetheless, the neural mechanisms underlying the dysregulation in these circuits~     are poorly understood. Emerging evidence indicates that metabolic abnormalities are highly~     relevant for the domain of cognitive function and indicate that alterations in metabolic~     pathways may be relevant to neurocognitive decline across different populations. The~     incretin glucagon-like peptide-1 (GLP-1) is a hormone secreted by intestinal epithelial~     cells. GLP-1 receptors are widely expressed in the central nervous systems. Pre-clinical~     trials have demonstrated significant neuroprotective effects of GLP-1. Ongoing clinical~     trials measuring cognition and mood in populations with various psychiatric disorders lend~     further impetus to explore the effects of GLP-1R agonists on brain structure and cognitive~     function. We hypothesize that GLP-1 and the GLP-1R are relevant for molecular and cellular~     processes that are thought to underlie the formation and maintenance of brain circuits. A~     derivative of this hypothesis is that the administration of GLP-1 agonists may result in~     enhanced neuronal survival and consequential increase in gray matter volume. We therefore~     propose to explore the cellular and molecular abnormalities within and between neural~     circuits subserving cognition using the GLP-1R agonist liraglutide.~      The overall goal of this study is to explore the relationship between a metabolic molecular~     target (i.e. the GLP1 system), the neural circuits of interest and the behavioral phenotype~     cognitive function.~   "
48379|NCT02423811|"~     Esophageal cancer is a common and fatal malignancy. It is the eighth most common incident~     cancer and the sixth leading cause of cancer death in the world. In Taiwan, esophageal~     cancer was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011.~     Squamous cell carcinoma is the predominant histological tumor type, accounting for about 90%~     of the cases. Esophageal squamous cell carcinoma (ESCC) is an aggressive disease,~     characterized with extensive local growth and frequent metastases. Concurrent~     chemoradiotherapy (CCRT) with or without surgery is the treatment option for locally~     advanced ESCC. Further, target therapy is used in conjunction with CCRT and surgery in ESCC~     since several years ago. However, the therapeutic outcomes are not satisfactory due to the~     emergence of chemo-radioresistance. It is imperative to investigate new biomarkers and to~     find novel treatment targets in ESCC.~      A small population of tumor-initiating cells or cancer stem cells (CSCs) possess some~     biological functions like normal stem cells, including self-renewal, asymmetric cell~     division, slowly proliferation rate and drug-resistance. CSCs from many primary tumors and~     cell lines express specific stem cell markers, including Oct4, Sox2, Nanog, CD133~     (promimin-1), Nestin, CD44 ,CD24, ALDH (Aldehyde dehydrogenase) and c-Kit. There are many~     evidences that CSCs are responsible for tumor initiation, progression and metastasis. CSCs~     are also believed to have important roles in cancer recurrence due to their resistance to~     anti-cancer drugs and radiation. CSCs express high levels of ATP-binding cassette (ABC)~     transporters. ABC transporter can pump cytotoxic drugs out of cells and is one important~     mechanism of multidrug resistance in CSCs. In addition, CSCs have high reactive oxygen~     species (ROS) scavenger expression to remove ROS produced from irradiation therapy.~      Fursultiamine (also known as thiamine tetrahydrofurfuryl disulfide, TTFD) is a derivative of~     vitamin B and currently used for nutrition supplement. The investigators have identified~     that Fursultiamine suppressed OCT-4, SOX-2, NANOG expression and decreased ABCB1 and ABCG2~     in tumor sphere of ESCC cell lines. In this project, the investigators will conduct a~     prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in~     ESCC patients. Stem cell markers in clinical specimens collected before and after CCRT will~     be evaluated.~   "
48380|NCT02423798|"~     The trial will investigate the accuracy and performance of a new sensor for continuous~     glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction~     with the new Medtronic 640G system components.~      To evaluate the accuracy and performance of the new generation Enlite sensor. This is a~     postmarket, interventional, open-label, non-randomized, single center clinical research~     trial.~      The trial will adopt a prospective single-sample design using the Yellow Spring Instruments~     (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood~     glucose (SMBG) plasma glucose reference sampling procedure at home.~   "
48381|NCT02423785|"~     In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of~     treatment regimens in the metastatic setting. Addition of bevacizumab to conventional~     chemotherapeutic combination regimens has improved the median overall survival of advanced~     colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit~     from anti-angiogenic approaches, would be highly desirable in order to optimize treatment~     strategies. Changes in ocular blood flow may be an attractive biomarker for predicting~     treatment response. In light of the given alternative first line treatment options such a~     predictive biomarker would be of clinical benefit. In the proposed study the investigators~     will assess potential changes in the ocular blood flow of mCRC patients after treatment with~     standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of~     treatment response as assessed by standard CT-scan~   "
48382|NCT02423772|"~     Chronic pain and misuse of opioids is a major public health problem, particularly in~     military veterans. The major goal of this project is to test the efficacy of an innovative~     behavioral treatment for chronic pain patients who are misusing prescription opiates. This~     project supports the strategic goals of National Center for Complementary and Integrative~     Health (NCCIH) and National Institute on Drug Abuse by examining a difficult and~     understudied problem with the ultimate goal of impacting scientific knowledge and human~     health.~   "
48383|NCT02423759|"~     The aim of the study is to evaluate whether changing antibiotic prophylaxis from~     fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted~     antibiotic prophylaxis according to rectal swab culture would influence infectious~     complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.~   "
48384|NCT02423746|"~     Purpose:~      This study is a feasibility trial of an existing evidence-based behavioral parent training~     program with parents of preschool-aged children who were born deaf or hard of hearing (DHH).~      The hypotheses of this study are (a) that a randomized control trial of the Family Check Up~     with this population will be feasible, (b) parents will rate the intervention as acceptable,~     and (c) a signal of effect will be observable among intervention group parents compared to~     controls for the following outcome variables: child behaviors, parenting behaviors, and~     parenting sense of competence.~   "
48410|NCT02423408|"~     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to~     evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a~     single qualifying Tension-Type-Headache (TTH).~   "
48411|NCT02423395|"~     Muscle cramps are common in patients with liver disease and associated with significantly~     diminished quality of life. Patients with cirrhosis often experience muscle cramps with~     varied frequency and severity. The exact mechanisms by which they occur remain unclear,~     although a number of pathophysiological events unique to liver disease may contribute.~     Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,~     and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent~     central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and~     other similar conditions. The combination of anticholinergic effects and CNS penetration~     make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles,~     and headaches. [3,4]~   "
48385|NCT02423733|"~     Depression is common and disabling but access to specialist treatment is often delayed with~     waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug~     therapies because of long waiting lists to see psychological therapists face to face despite~     recommendations by NICE (The National Institute for Health and Clinical Excellence) and~     others about the importance of non-drug therapies. One way to address this problem is to use~     computerized e-therapies which deliver structured cognitive behavioral treatment where the~     therapy can be accessed in a location and at a time that is convenient for patients and~     where there is no waiting list. Previous randomized controlled trials of e-therapies for~     depression have mainly been in people recruited through the internet or in clinical~     populations with mild disorders where many participants do not complete the on-line course.~     Despite this there is some evidence that clinician-assisted computerized cognitive behavior~     therapy can result in significant improvements in depression with reduced demands on~     clinician time. To date there have been no trials of clinician assisted e-therapy in~     secondary care.~      Therefore the aim of this clinical trial is to answer the question In patients on the~     waiting list for the mood program does a computerized therapy with an e-therapy coach~     compared to written information about depression and the availability of computerized~     treatments result in better outcomes, quicker improvements and the use of fewer resources~     after 12 weeks. The study will be a randomized controlled trial with health service use and~     PHQ-9 as the main outcome measures.~   "
48386|NCT02423720|"~     This is a audio based mindfulness meditation intervention for colorectal cancer patients and~     caregivers. A 8-week single arm study will be conducted among UCSF patients with metastatic~     colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants~     total).~   "
48387|NCT02423707|"~     Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic~     rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the~     long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT~     requires numerous subcutaneous allergen injections and takes several years to complete.~     Hence, there is a need to develop more convenient protocols for induction of allergen~     tolerance.~      Emerging evidence suggest that by targeting of antigen presenting cells within the lymph~     nodes the immunogenicity of the allergen can be enhanced and the number of injections can be~     reduced.~      The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a~     safe and effective treatment for patients with pollen-induced allergic rhinitis. The long~     term goal is to provide a base for a more efficient administration of ASIT, which will~     reduce both the dose necessary and the number of clinic visits associated with the~     conventional subcutaneous ASIT.~      The investigators will make an attempt to reproduce the results of a recent human study of~     intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.~      The first part of the study is completed and published (PMID: 23374268)~   "
48388|NCT02423694|"~     Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate~     tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of~     electroacupuncture stimulation.~   "
48389|NCT02423681|"~     To compare a group of patients with our standard treatment of continuous positive airway~     pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The~     therapy cost and the successfulness of the treatment will be measured. A humidifier is a~     water chamber that is currently added to CPAP only if the patients needs it.~   "
48390|NCT02423668|"~     To study the effective lens position concept in second eye refinement (SER) cataract~     surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD)~     measured in Pentacam and SER refractive outcomes.~   "
48391|NCT02423655|"~     This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese~     population. 16 tertiary hospitals across China will be randomly assigned into routine and~     deferred dialysis groups.~   "
48392|NCT02423642|"~     The purpose of this study is to study the effect of anticoagulation in immune response with~     Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).~   "
48393|NCT02423629|"~     Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral~     defects.~   "
48394|NCT02423616|"~     This study aimed to examine the possible relationship between hand grip strength (HGS) and~     maximum inspiratory pressure (MIP) in healthy individuals.~   "
48395|NCT02423603|"~     Normally, cells in human body divide in an orderly way. However in cancer cells, some~     important proteins, which help control cell growth, start to behave abnormally resulting in~     faster growth and multiplication. In this study, we are looking at a protein called AKT that~     helps the cancer cells to develop. Blocking the action of AKT with a drug like AZD5363 may~     slow down or stop the cancer growing. The development of AZD5363 is intended to provide a~     new treatment option for patients with cancer. The standard chemotherapy agent, Paclitaxel,~     is given to destroy cancer cells. AZD5363 may also make the cancer more sensitive to~     Paclitaxel and so make this agent more effective.~      A gene called PIK3CA has an important relationship with AKT. In tumours where this gene has~     been altered, or said to have 'mutated', the response to AZD5363 may be better. PIK3CA~     mutations are found commonly in breast cancers, and we will test for the presence of these~     mutations in both blood and tumour tissue samples that we ask you to provide. This study~     will also look at the relationship between tumours with PIK3CA mutations and the effect of~     the treatment.~   "
48412|NCT02423382|"~     The purpose of this study is to evaluate the effects of long-term tamponade with silicone~     oil on retinal saturation with Oxymap.~   "
48413|NCT02423369|"~     The purpose of this study is to assess whether peri-operative period in neonates and infants~     is associated with an increase in blood biomarkers, specific for neuronal injury, and to~     correlate them with clinical variables and sedative/analgesic agents. Patients, who meet~     inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for~     measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are~     drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During~     surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic~     and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and~     postoperative treatment, including analgesia and sedation, are given as per standard of~     care.~   "
48396|NCT02423590|"~     This study is being carried out to see if a new drug called Apatorsen in combination with~     standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung~     cancer.~      This study is part of a research project for collecting information about the effectiveness~     and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main~     purpose of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is~     an effective treatment for squamous cell lung cancer.~      Recent research has found that a protein called Hsp27 can help cancer cells protect~     themselves against the effects of cancer treatments. Hsp27 is only found in some lung~     cancers but when it is present, cancer drugs might not work as well as they would without~     Hsp27 being present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with~     Apatorsen may slow down or stop the cancer growing. This study will therefore look at the~     relationship between the Hsp27 levels in tumour and blood and the effect of the treatment.~      The development of Apatorsen is intended to provide a new treatment option for patients with~     cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and~     so make this chemotherapy treatment more effective.~   "
48397|NCT02423577|"~     The purpose of this study are to determine the effect FF-3 in comparison to placebo in~     subjects who are experimentally inoculated with a live, challenge strain of influenza A~     virus.~   "
48398|NCT02423564|"~     This investigation will evaluate the effect of Digesta-Lac in adults with occasional~     constipation in a single-center, randomized, double-blind, placebo-controlled, parallel~     group 2-arm study for 3 weeks.~   "
48399|NCT02423551|"~     The objective of this study is to determine the impact of consuming MREs as the sole source~     of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80~     free-living adults will be randomized to consume their usual diet or only MREs for 21~     consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research~     Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be~     collected periodically before, during and after the intervention to measure gut barrier~     integrity, gut bacteria community composition, and markers of gut health, inflammation, and~     nutritional status.~   "
48400|NCT02423538|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending~     (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and~     pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if~     applicable, the maximum tolerated dose determined.~   "
48401|NCT02423525|"~     The purpose of this study is to try to determine the maximum safe dose of afatinib that can~     be administered to people with brain cancer. Other purposes of this study are to:~        -  find out what effects (good and bad) afatinib has;~        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for~          use in pharmacokinetic (PK) studies;~        -  learn more about how afatinib might affect the growth of cancer cells;~        -  look at biomarkers (biochemical features that can be used to measure the progress of~          disease or the effects of a drug).~   "
48402|NCT02423512|"~     Vedolizumab is a new medication being used for the treatment of Crohn's disease and~     Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7~     lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous~     studies have shown that patients who have previous exposure to another type of medication~     for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to~     vedolizumab as well as those who have never been exposed. This study will investigate~     biologic markers in the blood and tissue the help identify possible reasons for this~     difference.~   "
48403|NCT02423499|"~     The objective of this study is to identify the specific characteristics of Autism Spectrum~     Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD)~     characteristics.~   "
48404|NCT02423486|"~     The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy~     and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary~     Incontinence patient.~   "
48405|NCT02423473|"~     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered~     parameters of connective tissue graft associated or not with composite resin for the~     treatment of gingival recession.~   "
48406|NCT02423460|"~     The daily requirement of threonine, an essential amino acid, will be evaluated in healthy~     adult males and in adult males with Crohn's Disease or ulcerative colitis using the~     indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated~     diets with varying levels of threonine.~   "
48407|NCT02423447|"~     It is the goal of the proposed study to compare the efficacy, as assessed primarily by~     sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter)~     for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable~     lung health and perform AC at home as part of their routine therapeutic regimen.~   "
48408|NCT02423434|"~     Through the multinational pooled dataset approach, this trial will aim to derive and~     validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the~     identification of diabetic polyneuropathy, and - more importantly - the identification of~     individuals at future risk. Results of the study will permit application in clinical~     practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification.~      The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes~     with and without neuropathy, who had CCM performed in the past as a part of their~     neurological examination, to assess concurrent and predictive validity of different CCM~     parameters in individuals . These subjects will be invited to the study to be re-examined by~     CCM along with other neurological tests (physical exam, nerve conduction studies,~     quantitative sensory testing, blood test and in some centres also skin biopsy) during the~     single study visit. Additionally CCM data will be analyzed both manually and by recently~     developed automated analytical software to evaluate accuracy of the automated method.~     Evaluation of automated image analysis will influence likelihood of successful knowledge~     translation of this surrogate biomarker for DPN into clinical practice - in which the~     procedure could be harmonized with annual retinal examinations - and into intervention~     trials.~      Secondary aim of the study is to determine the factors associated with CCM parameters and~     their longitudinal change and collect bio-samples for future research in this field.~   "
48409|NCT02423421|"~     The purpose of thus study is to determine if faecal microbiota transplantation will result~     in improvement in clinical outcomes in patients with irritable bowel syndrome.~   "
48417|NCT02423317|"~     The Airtraq optical laryngoscope has recently been available in pediatric sizes. The~     investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation~     devices in paediatric patients. This prospective, randomized study was conducted in a~     tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade~     I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal~     intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq~     (n = 30) laryngoscope. The primary outcome measures were time of intubation, ease of~     intubation, number of attempts and POGO score. We also measured hemodynamic changes and~     airway trauma.~   "
48418|NCT02423304|"~     50 periodontitis 50 healthy individuals serological evaluation will done to see association~     of 77A/G AND 11A/12A gene polymorphisms of MMP-13~   "
48419|NCT02423291|"~     Study Objectives Primary:~      • To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg~     administered intravenously every 3 weeks) as measured by the overall objective response rate~     in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.~      Secondary:~        -  To assess duration of tumor control, including duration of response and~          progression-free survival~        -  To assess survival~        -  To assess the safety and tolerability of Brentuximab vedotin~      Additional:~      • To assess disease-related symptoms~      Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study~     The study duration is 18 months for enrollment and 2 years for the follow-up.~   "
48420|NCT02423278|"~     The main purpose of this study is to evaluate the effect of extensive lymphadenectomy~     procedure in treatment of gastric cancer. This study is designed as a open-label,~     multi-centers, randomized controlled trial. The overall survival and free disease survival~     are primary outcomes, with postoperative complication, hospital charges, and life quality as~     secondary outcomes.~   "
48421|NCT02423265|"~     Anti-anginal drugs relieve ischemia and symptoms by reducing myocardial oxygen demand by~     reducing heart rate and or contractility (beta-blockers, phenylalkylamine and~     benzothiazepineate classes of calcium antagonists) or vasodilatation of the venous system~     (fall in pre-load) and coronary vessels.~      Late sodium channels remain open for longer in the presence of myocardial ischaemia.~     Ranolazine, a novel anti-anginal agent, acts by inhibiting the inward late inward sodium~     current (INaL), reducing intracellular sodium accumulation and consequently intracellular~     calcium overload via the sodium/calcium exchanger. It is currently thought that this~     reduction in intracellular calcium reduces diastolic myocardial stiffness and therefore~     compression of the small coronary vessels. There is considerable animal data to support this~     theory.~      There are good theoretical reasons to postulate that patients with chronically occluded~     vessels may derive less benefit from conventional anti-anginal agents, particularly~     vasodilators. The ischemic myocardium, subtended by the occluded vessel, will already be~     subject to significant concentrations of paracrine vasodilators such as adenosine.~     Ranolazine, therefore, may on the basis of its mechanism of action, provide greater relief~     of ischemia in such patients than conventional anti-anginal agents.~   "
48422|NCT02423252|"~     The purpose of this study is to investigate whether a psycho-cognitive nursing intervention~     including relaxation, guided imagery, touch and music listening can improve the clinical and~     psychological outcome of critically ill patients. The investigators hypothesize that,~     patients who receive the proposed psycho-cognitive nursing intervention will report lower~     stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower~     levels of inflammatory molecules, less complications and better self reported lived~     experience than patients who receive standard care alone.~   "
48423|NCT02423239|"~     This study is a trial of dexanabinol in patients with advanced tumours. The purposes of the~     protocol are to study different doses of the study drug to determine the maximum safe dose~     of the drug given in combination with standard chemotherapies and to further understand the~     safety of the study drug and to measure any reduction in size of patients' cancer tumour(s).~      Dexanabinol is a synthetic cannabinoid which has previously undergone clinical trials for~     traumatic brain injury (TBI) and in subjects undergoing coronary artery bypass surgery.~     Currently dexanabinol is under investigation for potential anti-tumour activity in patients~     with advanced tumours.~   "
48424|NCT02423226|"~     The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds~     implant plus systemic chemotherapy for locally recurrent rectum cancer.~   "
48425|NCT02423213|"~     Optical coherence tomography (OCT )provides high resolution information regarding the~     anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view.~     Much of this information is not able to be visualized by a clinician. Utilizing this~     information during surgery will allow for the ophthalmic surgeons to better understand how~     surgical procedures impact the anatomic structure of the eye.~      In this study an OCT device that has been built into the microscope (rather than mounted on~     the side or held in the surgeon's hand) and will be utilized to take images at various~     milestones during surgery to assess feasibility and potential utility of this technology.~     Since it is built into the microscope, there are potential significant advantages over a~     separate system including increased efficiency, improved working distance, and the ability~     to visualize tissue-instrument interactions.~   "
48426|NCT02423200|"~     This study will assess the effects of VX-745 on markers of disease in the central nervous~     system of patients with MCI due to AD or with mild AD. The study will also evaluate the~     safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the~     plasma and cerebrospinal fluid concentrations of VX-745 during dosing.~   "
48427|NCT02423187|"~     To investigate the safety and efficacy of long-term combination therapy with rabeprazole and~     low-dose aspirin.~   "
48428|NCT02423174|"~     The objective of the clinical trial is to determine the suitability of the FMwand~     Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.~   "
48429|NCT02423161|"~     OCT provides high-resolution information regarding the anatomic structure of the tissues of~     the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to~     be recognized by a clinician. Utilizing this information during surgery will allow for~     ophthalmic surgeons to better understand how surgical procedures impact the anatomic~     structure of the eye.~   "
48433|NCT02423096|"~     Background: Schizophrenia is a serious mental illness. The diagnosis and severity~     evaluations of schizophrenia are generally based on patient behaviors. Biomarkers are~     objectively measured and used as indicators for diagnosis confirmation, symptom assessment,~     and evaluation of pharmacologic responses to therapeutic interventions. Neuroendocrine and~     metabolite substrates are potential biomarkers of the pathogenic processes in schizophrenia.~      Aims: The aims of this study are to determine (a) the differences in neuroendocrine and~     metabolite substrates between patients diagnosed with schizophrenia and healthy controls;~     and (b) the associations among the neuroendocrine and metabolite substrates, cognitive~     function, clinical symptoms, and treatment responses of patients diagnosed with~     schizophrenia.~      Methods: (a) The investigators plan to recruit 100 patients diagnosed with schizophrenia and~     100 healthy controls as participants. (b) At the baseline and Week 12, patient blood samples~     will be obtained to measure the levels of neuroendocrine substrates and metabolite markers.~     Clinical symptoms and cognitive function will be evaluated. (c) For the healthy control~     participants, blood samples will be obtained once to measure neuroendocrine and metabolite~     marker levels.~      Expected Results: The results of this study may contribute to identifying potential~     neuroendocrine and metabolite biomarkers of schizophrenia, and clarify the associations~     among the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms,~     and treatment responses of patients diagnosed with schizophrenia. Such information is~     crucial for clinical evaluations and future research.~   "
48434|NCT02423083|"~     Background:~      - People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These~     cause neurological symptoms and sometimes disability. Researchers want to see if a blood~     pressure drug called guanabenz can repair lesions and help people with MS.~      Objective:~      - To see if guanabenz is safe and well tolerated in people with MS.~      Eligibility:~      - People 18 55 years old with MS who have taken glatiramer acetate for the past year.~      Design:~        -  Participants will be screened in a separate protocol. For 2 months, they will be~          examined and have magnetic resonance imaging (MRI) scans. This will decide if they are~          in the Stable or Active MS study group.~        -  The study will last 5 months. There will be up to 11 visits, 5 overnight.~        -  Visit 1: overnight stay at the clinic:~        -  Medical history and physical exam.~        -  Health questionnaire~        -  Bladder ultrasound scan~        -  Brain MRI~        -  Electrocardiogram (EKG) to measure heart electrical activity~        -  Blood will be drawn through an intravenous (IV) line.~        -  Participants may have tests of strength, muscle tone, and movement.~        -  They will get their first dose of the study drug, a tablet taken once a day.~        -  Participants will take the study drug at home and keep a medicine diary.~        -  The dose will slowly increase. Each time, participants will stay overnight at the~          clinic. They will have a physical exam, EKG, MRI, and IV blood draw.~        -  Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a~          schedule to slowly lower their drug dose and stop taking guanabenz.~        -  Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV~          blood draw.~   "
48435|NCT02423070|"~     Background:~      - Some people with advanced heart and lung disease have heart and lung transplants. But the~     organs are often rejected. When this happens, the organ recipients must have repeated~     biopsies. These are invasive and expensive. Researchers want to see if a blood test can~     predict rejection and take the place of biopsies. The test shows how much donor DNA is in a~     recipient s blood.~      Objective:~      - To see if a new blood test can be used instead of biopsies to diagnose rejection after~     transplant.~      Eligibility:~      - Adults 18 years and older who are on the lung or heart transplant waitlist.~      Design:~        -  Participants will have about 4 teaspoons of blood drawn from the arm before having~          their transplant.~        -  Researchers will collect demographic data about participants. They will also collect~          basic medical information about their condition.~        -  After surgery, while still in the hospital, participants will have 2 teaspoons of blood~          drawn twice a week until they go home.~        -  At each biopsy visit after the transplant, participants will have 4 teaspoons of blood~          drawn for testing for up to 5 years.~   "
48436|NCT02423057|"~     Background:~      - Genes are made up of DNA and are the instruction book for cells. When people have cancer,~     some of the genes that might have slowed the growth of tumor cells were turned off.~     Researchers think a drug called TdCyd might help to turn these genes back on. This may slow~     the growth of tumors in people with cancer.~      Objectives:~      - To test the safety of TdCyd and to find out how it works. Also, to find out the dose of~     the drug that can be safely given to humans.~      Eligibility:~      - Adults 18 years and older who have advanced cancer that has progressed after standard~     treatment, or for which no effective therapy exists.~      Design:~        -  Participants will take TdCyd by mouth. The drug is given in 21-day cycles. TdCyd is~          taken once a day during week 1 for 5 days. Then for 2 days participants do not take the~          drug. Then they take it for 5 days during week 2. No TdCyd is taken during week 3.~        -  Participants will keep a diary of their study drug doses.~        -  Participants will have tests about every 3 weeks to see how the study drugs are~          affecting their body. They will have blood and urine tests, a medical history, and~          physical exams. They may have computed tomography (CT) scans to measure their tumors.~          They may have an electrocardiogram, which measures the heart electrical activity.~        -  If participants develop any side effects, they may be asked to visit more often.~        -  Participants will stay in the study as long as they are tolerating TdCyd and their~          tumors are either stable or getting better. One month after stopping the drug, they~          will have a follow-up phone call.~   "
48478|NCT02422511|"~     The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a~     research study exploring the use of genomic sequencing in newborns. The National Institutes~     of Health is funding this study.~      The investigators will enroll 240 healthy infants and their parents from the Brigham and~     Women's Hospital (BWH) Well Newborn Nursery and 240 sick infants and their parents at Boston~     Children's Hospital (BCH) or the BWH Neonatal Intensive Care Unit (NICU). A small blood~     sample will be collected from each infant and genome sequencing may be performed. Six weeks~     later, results are returned and explained. Over 12 months the investigators are studying the~     experiences of parents and pediatricians of infants who receive sequencing to help~     understand how best to use genomics in pediatric care.~   "
48479|NCT02422498|"~     The study is being done to find out if the results of a pre-treatment biopsy can predict~     response to cisplatin and radiation treatment for patients with metastatic or recurrent~     triple negative breast cancer.~   "
48437|NCT02423044|"~     Background:~      - Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people~     with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study~     how people become fearful of situations. They want to understand how the brain learns when~     it is helpful to feel fear and when it is not.~      Objective:~      - To better understand brain processes related to fear and anxiety.~      Eligibility:~        -  Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder,~          social anxiety disorder, or post-traumatic stress disorder.~        -  Right handed volunteers ages 18-50 without psychiatric disorders.~        -  And free of psychiatric medication for 2 weeks~      Design:~        -  Participants will first be screened under another protocol.~        -  Participants will play a video game inside a magnetic resonance imaging (MRI) scanner.~          The scanner is a metal cylinder It is surrounded by a strong magnetic field.~          Participants will lie on a table that can slide in and out of the scanner. A device~          called a coil will be placed over the head.~        -  During the scan, participants may play a virtual reality video game. Game instructions~          will be explained before they enter the scanner.~        -  While playing the game, participants will wear 2 electrodes on their fingers. These~          measure sweat on the skin. They will also have 2 small electrodes attached to the left~          hand. These can give brief mild electrical shocks.~        -  Participants will be asked questions when playing the game during the scan.~        -  Before and after the scan, participants will fill out questionnaires about their~          emotions. They may complete questionnaires online while at the clinic.~   "
48438|NCT02423031|"~     Background:~      - Medical problems and treatments can cause stress in some people. Researchers want to learn~     more about how to measure distress in young people with medical illnesses. A screening tool~     called Checking In will be developed in order to help researchers find ways to identify~     concerns and stresses common to this group.~      Objective:~      - To create a screening tool that will help health care providers identify psychological and~     social distress in young people with serious illnesses.~      Eligibility:~      - Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time~     of the study.~      Design:~        -  Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks~          about mood, pain, fatigue, peer relationships, and sleep. During this phase,~          participants will be asked about the wording of the questions in Checking In. They will~          also talk about what they thought of the questions and if they understood them.~        -  Phase 2 will not involve participant enrollment. During this phase the researchers will~          be working with technologists to develop the software for an electronic version of~          Checking In.~        -  Phase 3 participants will complete an electronic version of Checking In. Researchers~          will ask questions about the ease or difficulty of using an electronic screen.~        -  Phase 4 participants and one of their caregivers will complete an electronic version of~          Checking In. They will also complete other questionnaires related to mood, pain~          fatigue, peer relationships and sleep. They will be asked their thoughts about using~          Checking In. On the same day, their NIH doctor will get summary data about their~          questionnaire answers. The doctor will also provide feedback about the summary form.~        -  Researchers will compare data from Checking In with data from the other questionnaires.~   "
48439|NCT02423018|"~     The purpose of this study is to determine if a single dose of pregabalin 300mg in patients~     receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful~     differences in measures of drug liking and drug high as compared to placebo.~   "
48440|NCT02423005|"~     A prospective, randomised, controlled, single-blind, multi-site clinical study employing~     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women~     suffering from stress urinary incontinence.~      Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary~     incontinence will be enrolled in this study. All patients who are considered eligible to~     participate in the clinical study and give consent will be randomised to complete either a~     12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment~     programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will~     be completed by the subjects at home with treatment with the device in accordance with the~     device Instructions for Use.~   "
48441|NCT02422992|"~     This is a case/control epidemiology study to identify what are the iron-metabolism~     abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD~     predisposition.~   "
48442|NCT02422979|"~     This is a Phase 1, two part, study of patients with recurrent Head and Neck Cancer (HNC),~     who in the opinion of their physician, cannot be satisfactorily treated with surgery,~     radiation or platinum chemotherapy. Part I is a drug dose-escalation, fixed low fluency~     light application study to determine the drug dose that can be safely given to saturate the~     epidermal growth factor receptor (EGFR) at the tumor.~      Part II is a light treatment dose-escalation, fixed drug dosing infusion study to determine~     the optimal light application, in combination with the Part I drug dose, needed to achieve~     clinical response with an acceptable safety profile.~   "
48443|NCT02422966|"~     The purpose of the study is to assess the efficacy and safety of paracetamol in comparison~     to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.~   "
48444|NCT02422953|"~     Widespread food insecurity and malnutrition are largely the main impairing factors for human~     capital development in Pakistan. Rates of chronic malnutrition are very high, and acute~     malnutrition is critical: 44% of children under five are stunted and nationwide global acute~     malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of~     15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting~     rates were at 36%.~      This study evaluates the effectiveness of food based interventions to prevent stunting among~     children under-five years with focus on window of opportunity (1000 days from conception to~     2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months~     will receive supplements on monthly basis in intervention areas, while participants in~     control areas will receive routine public health services available in the study area.~   "
48445|NCT02422940|"~     This is an extension study to evaluate the long-term safety, tolerability, and efficacy of~     two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12~     months to subjects with chronic post-ischemic stroke walking deficits who have completed the~     controlled, double-blind Study DALF-PS-1016.~   "
48446|NCT02422927|"~     The investigators tested if a nutraceutical combination with red yeast rice, berberine and~     policosanol (NC) can significantly modify inflammation, lipid profile and markers of~     endothelial injury (endothelial microparticles) in subjects with elevated levels of~     high-sensitivity C-reactive protein (hsCRP).~   "
48480|NCT02422485|"~     This is a multi-center, open label, pilot futility clinical trial of the safety,~     tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10~     patients with PSP.~   "
48596|NCT02420977|"~     This research is being done to see if an investigational radioactive imaging agent~     (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the~     prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate~     cancer before surgery.~   "
48447|NCT02422914|"~     Background. Smoking is considered a global public health problem. For this reason, the~     smoking dependence was called by experts as a global epidemic.~      Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has~     been an important expansion in many countries. Nevertheless, there is poor evidence that TFC~     are beneficial for smoking cessation. In particular, even though it has been proved that the~     nicotine replacement devices helps many individuals to give up smoking and to tolerate the~     withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested~     its contribution in tobacco reduction. This protocol in particularly innovative, since it~     aims to test the efficacy of electronic devices in a screening program (the lung cancer~     prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in~     order to lower individual's risk.~      Methods and Design. This experimental protocol has been designed with the main aim to~     investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping~     smokers to improve their lung health and to quit or reduce tobacco consuming. In particular,~     the investigators aim at investigating clinical (physical symptoms, with particular focus on~     breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked),~     and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.~      The investigators will also analyze, as a secondary aim, the psychological and lifestyle~     component of smokers involved in order to fine correlation data that might be used to~     compute a predictor index able to suggest the probability of success, with respect to the~     reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The~     study will be organized as a nested randomized controlled study with two arms: one~     experimental group and one control group. The study will be nested in the screening program~     for lung cancer, where subjects will be recruited.~      All subjects will be entered in a psycho-cognitive low-intensity counseling program (6~     months), but in the experimental group a TFC (with or without nicotine) will be used as~     replacement device for three months, while in the control group only low-intensity~     counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the~     FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep~     quality and physical activities.~   "
48448|NCT02422901|"~     The aim of this long-term observational study is the documentation of the use of PASCORBIN®~     7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the~     investigators focus on the acquisition of data of the underlying diseases and the reduction~     of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this,~     exact assessment of medical tolerance and details of treatment requirements are further~     aims. Here the investigators take into account acute and chronic underlying medical~     conditions. Further health economic data are collected.~   "
48449|NCT02422888|"~     The current trial will compare the protective effect of ticagrelor and prasugrel on~     microvascular dysfunction in patients with revascularized ST elevation myocardial~     infarction.~   "
48450|NCT02422875|"~     The purpose of this study is to compare immune phenotype, function, and specificity of B~     lymphocytes from different developmental stages in autoimmune patients to B cells from~     infectious disease patients and healthy controls.~   "
48451|NCT02422862|"~     Frequently, headache is associated with disorders of the cervical spine, specially on the~     upper cervical spine. Therefore, restoration of the upper cervical mobility is considered~     fundamental for the treatment of headache.~      Manual therapy interventions seek to restore upper cervical mobility through a wide range of~     therapeutic procedures, including mobilization or manipulation techniques. Previous~     systematic reviews reported preliminary evidence for the application of upper cervical~     manual therapy techniques for the management of headache.~      The objective of this study is to study the effects of upper cervical translatoric spinal~     mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold~     in subjects with headache. For this purpose, the investigators will conduct a randomized~     controlled trial. Volunteers with headache will participate in the study and will be~     randomly divided into control or treatment group. Treatment group will receive UC-TSM and~     the control group will receive no treatment.~      Headache intensity, cervical mobility, temporomandibular mobility and pressure pain~     thresholds (PPT) will be measured before and immediately after each treatment session (3~     treatment sessions in one week period) and after one month follow-up. At this moment, global~     perceived effect will be assessed.~   "
48452|NCT02422849|"~     the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to~     hospital admissions in this age group. However hospital admission is linked to adverse~     events. like confusion, medication errors or new infections.~      the ACCESS project aims to examine alternatives to acute admissions for senior medical~     patients.~      the aims are:~        1. How many patients will be admitted to hospital due to acute medical conditions if cared~          for by their own General Practitioner (GP) versus a hospital intern specialist ?~        2. how many patients will be admitted to hospital due to acute medical conditions if cared~          for by acute team in their home versus in specialised care centres ?~   "
48453|NCT02422836|"~     The subjects will use the test skincare products. This is a full face, twice daily~     application study, with digital photos and expert grader evaluations at Baseline, 4 and 8~     week periods. If the subject meets the study criteria and is enrolled, they will be~     instructed at screening visit to discontinue the use of any facial products (except dry~     mineral foundation and eye make-up) for seven (7) days before beginning the study (referred~     to as the washout period). They will return to the site for the baseline visit 2 after the~     required 7 day washout period (visit can occur within 1 week after screening visit).~   "
48454|NCT02422823|"~     Ninety patients with irreversible pulpitis diagnostic will participate in this clinical~     study. The participants will be divided into 2 groups of 45 patients, who will receive the~     inferior alveolar nerve block injections of 1.8 mL of 4% articaine (Articaine 100; DFL, Rio~     de Janeiro, RJ, Brazil) with 1:100,000 epinephrine or 3.6mL of the same solution. Two~     consecutive negative responses to the maximum pulp stimulus (80 µA) at the electric pulp~     test were the criterion to determine a pulpal anesthesia as successful. Ten minutes after~     the IAN block, subjective lip anesthesia will be evaluated by asking the patient whether~     his/her lip was numb. Thereafter and immediately before the pulpectomy, the electric pulp~     stimulations will be repeated to determine pulpal anesthesia. During the pulpectomy~     procedure, the patients were instructed to report any painful discomfort. To evaluate the~     intensity of pain during the pulpectomy, a verbal analogue scale will be used. The~     anesthesia will be defined as successful when the dentist accessed the pulp chamber without~     pain being reported by the patient. In these cases, the pulpectomy will be continued. If~     report pain will classified the IAN block as unsuccessful.~   "
48455|NCT02422810|"~     The purpose of this study is to characterize a new test to assess the rate and time it takes~     to form a blood clot in people who either do or do not take aspirin.~   "
48481|NCT02422472|"~     The purpose of this study is to compare ultrasound guided peripheral IV placement with and~     without the use of a guidewire. Patients in the Emergency Department with difficult~     peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented~     and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided~     peripheral IV placement with modified seldinger technique using a guidewire.~   "
48456|NCT02422797|"~     The aim of this study is to determine if virologically suppressed, human immunodeficiency~     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside~     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon~     switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will~     primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily~     compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch~     visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR~     will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse~     transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a~     148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52)~     and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study~     eligibility criteria will participate in the Early Switch Phase where they will either~     switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end~     of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all~     participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until~     Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the~     Continuation Phase. The study is planned to be conducted in approximately 476 participants.~   "
48457|NCT02422784|"~     This is a cross-sectional study designed to compare plasma/serum and urine vitamin D~     metabolite profiles of vitamin D sufficient and insufficient individuals.~      There are two phases of this study.~      Phase 1 - Consented study participants will attend a screening visit and provide a fasting~     blood and urine sample. Those individuals who are vitamin D insufficient based on serum~     25(OH)D concentrations will be invited to participate in Phase II~      Phase II - is a double-blind, randomized, control study designed to examine vitamin D status~     in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible~     participants will be asked to consume one of three beverages: i) rooibos iced-tea (control);~     ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos~     iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of~     iced-tea consumed daily for 6 weeks. Participants will attend 6 weekly visits following~     baseline and provide a fasting blood sample for assessment of serum 25(OH)D concentrations.~      Objectives: 1) To investigate plasma/serum and urine vitamin D metabolite profiles in~     vitamin D sufficient and insufficient individuals; and 2) To determine the effects of~     vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers~     of vitamin D and calcium metabolism, and vitamin D metabolite profile in plasma/serum and~     urine of vitamin D insufficient individuals.~   "
48458|NCT02422771|"~     In response to high injury rates in soccer, the Fédération Internationale de Football~     Association (FIFA) developed an injury prevention program called the 11+. It is designed~     to replace a standard warm-up and takes about 20 minutes to complete. The program has proven~     remarkably effective in decreasing the rate of injury in soccer players. However, uptake of~     the 11+ has been less than desired. Adoption of the program may be increased if additional~     benefits can be demonstrated and the program is introduced at a younger age. The goals of~     this study are to (1)establish that young athletes can tolerate the program, and (2)measure~     the effects of the 11+ program on the physical performance of 10-12 year old girls. Three~     teams will be randomly assigned to the intervention group and carry out the 11+ program for~     the duration of the indoor soccer season. Another 3 teams will continue with their usual~     warm-up. Pre- and post-intervention, balance, agility, core strength and movement control~     will be assessed in all athletes. The investigators hypothesize that the athletes will~     tolerate the program well and that the intervention group will improve on the performance~     tests significantly more than the control group.~   "
48459|NCT02422758|"~     Perioperative hypothermia brings numerous and recognized postoperative complications. Active~     warming intraoperatively helps to maintain body temperature in the postoperative period, but~     there are few studies in Brazil, assessing the effect of prewarming in maintaining~     normothermia. It is believed that prewarming with forced air warming system keep the body~     temperature during intra and post-operative. This study aims to evaluate the effect on~     prewarming maintaining body temperature of patients undergoing elective surgery of~     Gynecology specialty using the forced air warming system. The study is experimental design,~     controlled type randomized clinical trial, with simple blinding for patients. Eighty adult~     patients undergoing gynecological surgery in the art, with a surgical time of at least an~     hour will be randomized and allocated into experimental groups - prewarming system with~     forced air warming system for 20 minutes, and control - Prewarming with sheet and blanket~     for 20 minutes. The patients will be kept warm during the anesthetic-surgical procedure. The~     measurement of temperature will be using a tympanic thermometer. Participants will be~     followed from receiving the surgical center to the end of surgery. Data will be recorded in~     validated instrument. Data analysis will be used the Model Linear Mixed Effects and the~     Structure Error Auto-Regressive.~   "
48460|NCT02422745|"~     The purpose of this study is to determine whether taking daily, dietary supplements of cocoa~     extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard~     multivitamin reduces the risk of developing cardiovascular disease (including heart attack,~     stroke, coronary revascularization, and cardiovascular mortality) and cancer.~   "
48461|NCT02422732|"~     A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol~     in children with NF1 with or without reading disabilities.~   "
48462|NCT02422719|"~     The purpose of this study is to determine whether radotinib is effective and safe for~     patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to~     prior 2 or more tyrosine kinase inhibitors.~   "
48482|NCT02422459|"~     The purpose of this study is to determine whether the combination of self-management~     support, pain science education, and individualized, goal-oriented exercises helps people~     with chronic pain to increase their function.~   "
48483|NCT02422446|"~     This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid~     (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention~     among adults with elevated triglycerides and type 2 diabetes.~   "
48484|NCT02422433|"~     The purpose of this research is to test the feasibility, sensitivity, and specificity of the~     marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus~     (BE).~   "
48463|NCT02422706|"~     Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor~     (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one~     of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used~     instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .~      However, a recent study based on the Maastricht III guidelines, indicated that treatment~     with a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an~     intention-to-treat (ITT) basis, and will fail in ~ 50 % of patients who treated with~     PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue~     warranting the investigation of other agents. Helicobacter pylori infection has become~     increasingly resistant to traditional first-line treatment regimens because of emerging~     antibiotic resistance coupled with poor patient compliance with completing the treatment~     course that decrease H. pylori eradication rates. So there is a considerable interest in~     evaluating new antibiotic combinations and regimens .~   "
48464|NCT02422693|"~     The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic~     exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain~     in patients with specific chronic low back pain.~   "
48465|NCT02422680|"~     The study aim to capture key quality indicators and patient satisfaction for at least 500~     patients referred for a colonoscopy at Aalborg University Hospital. The patient population~     is mix of screening and non-screening colonoscopies seen at our out-patient clinic.~      Each Colonoscopy is registered using a specially designed registration form and a more~     detailed form relating to the colonoscopy itself. The data collected includes: Endoscopy~     experience and education, Medicine use, Colonoscopy duration, Caecum Intubations rate and~     documentation, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse~     assisted Gloucester Comfort score. Each patient were given a questionaire with 6 questions~     answering satisfaction, pain, discomfort etc on a 10 cm analog scale.~   "
48466|NCT02422667|"~     The goal of this registry is to review the data collected and research ways to improve~     patient safety, quality of care, and medical decision-making, reduce medical spending, and~     help advance orthopedic science and bioengineering.~   "
48467|NCT02422654|"~     Primary Objective:~      The purpose of this study is to assess the palatability of eliglustat prototype liquid~     formulations in healthy subjects.~   "
48468|NCT02422641|"~     Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an~     area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity~     against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the~     blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky~     leptomeningeal disease, and provide treatment to systemic disease burden. While two~     retrospective studies have suggested activity of HD-MTX in LMD in patients with breast~     cancer, no prospective data are available to inform its inclusion in treatment regimens.~     Thus, while HD-MTX is included in the NCCN Guidelines for LMD and while it is used to~     varying degrees in cancer centers across the nation, this is more representative of the lack~     of available therapies for LMD as opposed to strong evidence-based data. This phase II,~     prospective study will evaluate systemic, intravenous HD-MTX in breast cancer patients with~     leptomeningeal metastasis with or without brain parenchymal metastasis.~   "
48469|NCT02422628|"~     Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient~     and clinical outcome.~   "
48470|NCT02422615|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial in men and~     post-menopausal women with advanced breast cancer.~   "
48471|NCT02422602|"~     This study is multicentric, single-blind, and interventionnal with a randomization into two~     parallel arm, between a standard of care information and an additionnal information of the~     patient, with a 12 month follow up.~      The aim of this study is to evaluate the effectiveness of a personalized information~     programm versus information provided from standard of care in patients taking Xarelto for~     Stroke Prevention in Atrial Fibrillation.~   "
48472|NCT02422589|"~     The purpose of this study is to evaluate the potential inhibitory effects of ceritinib on~     the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin,~     respectively, when administered simultaneously as a cocktail. The results obtained from this~     drug interaction study will provide guidance that will enable an update to the ceritinib~     labeling and will help guide recommendations for administration of co-medications in future~     clinical trials.~   "
48473|NCT02422576|"~     Assessment of the improvement of the safety of the swallowing function under 3 natural~     ingredients known to be agonist of sensory receptors.~   "
48474|NCT02422563|"~     Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with~     pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in~     patients with cervical cancer FIGO IB2 and IIB.~   "
48475|NCT02422550|"~     Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods~     used to diagnose tumor stage before treatment in Radiology Oncology Department. It is also~     used to check responses to radiation after treatment. However, MRI isn't traditionally used~     in planning for radiation treatment or in checking treated tumor and tissue changes during~     radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques~     in these settings of radiation treatment. Participating in this study would NOT change the~     current treatment plans, this will allow the investigators to use the MRI methods in~     research and future patient care.~   "
48476|NCT02422537|"~     During this project the effect of 3 different bran-based dietary platforms on the~     fermentation on a readily fermentable substrate will be investigated using stable isotope~     techniques.~   "
48477|NCT02422524|"~     This is a Phase 1, single dose, open-label, sequential group study comparing the~     pharmacokinetics and safety of PA-824 in subjects with mild, moderate, and severe hepatic~     impairment to matched, non-hepatically impaired subjects. Primary objective: To evaluate the~     pharmacokinetics of a single oral dose of PA-824 in subjects with mild, moderate, and severe~     hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically~     impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of~     PA-824 in subjects with mild, moderate, and severe hepatic impairment (as assessed by~     Child-Pugh score), relative to matched non-hepatically impaired subjects.~   "
48485|NCT02422420|"~     The objective of this study is to test whether two different participant financial incentive~     structures are more effective and cost effective than minimal financial incentives in~     increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing~     diabetes. The incentives are tied to participation and weight loss in the evidence-based~     group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a~     group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class~     for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if~     successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk~     among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions,~     (b) demonstrate that prevention of chronic disease risk factors using patient incentives is~     cost-effective, and (c) provide a patient incentive model that can be widely used among~     Medicaid beneficiaries at risk for developing diabetes.~   "
48486|NCT02422407|"~     The main objective of the study is to characterize the gene expression in immune and~     epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's~     syndrome) and non-pSS participants including healthy volunteers.~   "
48487|NCT02422394|"~     Inherited thrombocytopenias are a heterogeneous group of disorders characterized by a~     reduced number of blood platelets and a consequent bleeding tendency that ranges from mild~     to life-threatening. Thrombocytopenia is caused by genetic mutations and therefore is~     present throughout patients' life and can be transmitted to the progeny. Some patients with~     severely reduced platelet count present spontaneous bleedings, which represent a major~     clinical problem: in fact, bleeding diathesis exposes these subjects to the risk of severe~     hemorrhages, affects their quality of life and often requires hospitalization and/or~     transfusions. Conversely, other patients with inherited thrombocytopenias have absent or~     mild spontaneous bleeding tendency. However, even these patients are at risk of major~     bleedings on the occasion of surgery or other invasive procedures. Therefore, the potential~     for hemorrhages on the occasion of invasive procedures represent a clinical problem for all~     patients affected by inherited thrombocytopenias.~      Eltrombopag is a drug, available in tablets, which stimulates the production of platelets by~     the bone marrow. A previous study demonstrated that a short course of eltrombopag was~     effective in increasing platelet count in most patients with the MYH9-related disease~     (MYH9-RD), one form of inherited thrombocytopenia. Eltrombopag was given for 3 to 6 weeks to~     12 patients with MYH9-RD and platelet counts lower than 50 x10e9/L. Eleven patients~     responded to the drug and 8 of them obtained platelet counts higher than 100 x109/L or three~     times the baseline value. Remission of spontaneous bleeding was achieved by 8 of 10 patients~     and treatment was well tolerated in all the cases. Based on these findings, short-term~     eltrombopag courses have been successfully used for preparing for major surgery two patients~     with MYH9-RD and less than 20 x10e9 platelets/L.~      The present study has two main objectives.~      - To verify if eltrombopag is effective in transiently increasing platelet count over 100 x~     109/L and abolish bleeding tendency in patients with different forms of inherited~     thrombocytopenia.~      To this end, eltrombopag will be given for 3-6 weeks to patients with different forms of~     inherited thrombocytopenia. Eltrombopag will be administered at the dosage of 50 mg/day for~     3 weeks. After 3 weeks of treatment, the patients who will obtain a platelet count higher~     than 100 x10e9/L will stop therapy. The patients who will achieve a platelet count lower~     than 100 x10e9/L will be treated with eltrombopag at a higher dosage (75 mg/day) for 3~     additional weeks. This treatment schedule is called Phase 1 of the study.~      If the study will achieve this goal, short-term eltrombopag could be potentially used in the~     future to prepare these patients for surgery or other invasive procedures~      - To verify if eltrombopag can be used to stably reduce spontaneous bleeding tendency for~     long periods of time in patients with clinically significant spontaneous bleedings.~      To this end, patients with clinically significant spontaneous bleedings and who had their~     bleeding tendency reduced during the Phase 1 of the study without severe side effects, will~     be admitted to the Phase 2 of the study. During the Phase 2, patients will be treated with~     eltrombopag for 16 weeks. In order to determine the lowest dose of eltrombopag that is able~     to reduce or abolish their bleeding tendency, patients will start treatment with eltrombopag~     25 mg/day for 4 weeks. Then, every 4 weeks, patients will be re-evaluated and the dosage of~     eltrombopag will be adjusted according to the bleeding tendency of the 7 days before~     evaluation. The dosages of eltrombopag that can be used in the Phase 2 range from 12.5 to 75~     mg/day.~      Other objectives of the study are:~        -  to evaluate safety and tolerability of Eltrombopag in patients with inherited~          thrombocytopenias.~        -  to identify the dosages of Eltrombopag required to obtain the objectives of Phases 1~          and 2.~        -  to study the effect of treatment on some laboratory parameters related to platelet~          production and function.~      All patients will be undergo a follow-up visit 30 days after completion of treatment.~      Patients will be treated as outpatients.~      The evaluation of patients at enrollment includes: medical history; physical examination;~     peripheral blood examinations to count blood cells, to examine blood cells by microscope, to~     measure some parameters related to liver/kidney function and platelet production; standard~     urine analysis; ophthalmic assessment. Studies for dose adjustment includes the same~     examinations performed at enrollment with the exception of ophthalmic assessment. Evaluation~     of patients at the end of the Phases 1 or 2 and 30 days after the end of treatment includes~     the same examinations performed at enrollment: moreover, in patients who will obtain a~     platelet count higher than 100 x10e9/L, the in vitro platelet function will be studied.~   "
48488|NCT02422381|"~     This is a study for patients with previously-treated advanced non-small cell lung cancer~     (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to~     standard treatment with gemcitabine. The study will also try to identify the best dose of~     MK-3475 to give in combination with gemcitabine.~   "
48489|NCT02422368|"~     ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized,~     triple masked, clinical trial of a selected combination of vitamins and minerals versus~     placebo in patients with moderate to severe thyroid eye disease. The trial has a~     parallel-arm design.~   "
48490|NCT02422355|"~     In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by~     the competent authorities (CE mark). It is designated to stabilize medial femoral neck~     fractures in a minimal invasive technique. The implant combines an angular stable device~     with screw in screw technology for rotational stability. Therefore the purpose of this~     focused registry is to investigate how the newly developed and approved implant called FNS~     is performing clinically and radiologically in terms of surgical technique, intra- and~     postoperative complications and short term outcome.~   "
48491|NCT02422342|"~     The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure~     and Cardiac Output) generated by an application coupled with an off-the-shelf pulse~     oximeter. The validation will be done by comparing the generated information to data~     gathered while performing Stress Echocardiography. The first phase of the study will be done~     on 10 patients undergoing a Stress Echocardiography test at the cardiology department at~     Meir Hospital~   "
48492|NCT02422329|"~     The goal of this research study is to learn how patients' think about constipation before~     and after receiving education about the subject.~   "
48493|NCT02422316|"~     Background:~      Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will~     have Acute Myocardial Infarction. However, several studies indicate that patients where ACS~     had been excluded by conventional methods sustain a higher cardiac morbidity and mortality~     than the background population. Not all of these patients can be identified by traditional~     risk factors such as cholesterol, hypertension, and diabetes or with conventional methods~     such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of~     calcification in the coronary arteries and might be a useful addition in predicting future~     cardiac events in this patient group. The aim of this study is through a double-blinded~     study to determine whether non-contrast CT scan with calcium score can be used to identify~     patients at increased risk of death and cardiac event within the following 12 months after~     an acute admission where troponin measurements were normal.~      Methods:~      The study will investigate patients with suspected Acute Coronary syndrome who have been~     examined and subsequently sent home from an emergency- or cardiology department without ACS~     or another obvious explanation. 750 patients, age 30-70 years who are included in the study:~     Identification of risk factors in non-cardiac chest pain patients will be offered a~     non-contrast CT scan with calcium score within 14 days after the hospital contact. The~     participants will be included in a 12 months follow up, where the result of the calcium~     score is not revealed neither for the patient nor the investigator. After 12 months the~     results of the scan is compared with the rate of cardiac events. This project is a~     multicenter study and recruits patients from 6 emergency - and cardiology departments in the~     region of Southern Denmark.~      The study commences at September 2014 and results of this project are expected to contribute~     to the risk stratification of Non-cardiac chest pain patients.~   "
48494|NCT02422303|"~     Ketamine has been shown to have an antidepressant effect when given intravenously in doses~     of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is~     known in this instance to decrease postoperative pain. No one has studied whether or not~     ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an~     antidepressant effect on surgical patients who suffer from depression. The study is designed~     to determine whether or not a small dose of ketamine when given at the induction of~     anesthesia could have an antidepressant effect on surgical patients with depression.~   "
48495|NCT02422290|"~     This pilot study is proposed to determine the acceptability, feasibility and potential~     efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid~     treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults~     with OCD. This study will recruit 5 youth (ages 14-20) who are diagnosed with clinically~     significant OCD and have failed at least two adequate trials of Serotonin Reuptake Inhibitor~     (SRI) medications and a course of Cognitive-Behavioral Therapy (CBT) for OCD in the past.~     Participants will receive a single infusion of intravenous ketamine and be assessed at~     regular intervals post-infusion for up to 14 days. At the end of the 14-day treatment phase,~     all participants will be offered three months of open treatment for OCD with medication~     and/or CBT.~   "
48496|NCT02422277|"~     The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock~     wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.~   "
48497|NCT02422264|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women~     who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if~     the presence of transplacentally transferred maternal antibodies interfere with the immune~     response to primary vaccination with Infanrix hexa and a co-administered pneumococcal~     conjugate vaccine given as a part of this study in infants.~   "
48727|NCT02419274|"~     Deep Phenotyping of adult asthma patients:~        -  severity from mild to severe~        -  both atopic and non-atopic~        -  both childhood and adult onset~        -  both smokers and non-smokers~        -  corresponding pediatric cohort (KIRA) with equivalent SOPs regarding collection of~          biomaterial and clinical data incl. lung function, further processing of biomaterial~          and further analyses~   "
48498|NCT02422251|"~     The aim of the project is to compare the biomechanics of three different bearing designs~     used in total knee replacement (TKR) implants. The bearing is the part in the middle of the~     knee implant that allows the metal tray attached to the shin bone (tibia) to move in~     relation to the metal part attached to the thigh bone (femur) and is usually made of plastic~     (high density polyethylene). There will be three different bearing types in the study, which~     all give different movements. This study will see which bearing is most like a natural knee~     and so which design gives the best function and feeling to patients with a TKR. 90 TKR~     patients from the Golden Jubilee National Hospital will be recruited and randomised to~     receive one of the three study bearings (30 in each group). In addition, a control group of~     30 healthy individuals of similar age will be recruited for comparison. Before surgery and~     at 4 to 8 weeks and 1 year after their operation patients will attend biomechanical~     assessment sessions at the University of Strathclyde. The control group will attend the~     assessment session only once. In each of these sessions they will carry out a number of~     everyday tasks such as walking, moving from sitting to standing and going up and down~     stairs. These tasks will be measured using motion capture techniques. Reflective markers~     placed on each participant will be tracked by cameras so that their movements can be~     recorded. Force plates in the floor will record the forces during the tasks.~      Movement and force data will be analysed to see if any differences exist between the groups~     and show which bearing gives the most natural movement.~   "
48499|NCT02422238|"~     The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with~     proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the~     development of NASH in patients with simple steatosis and to identify and validate~     non-invasive markers for the diagnosis of NASH.~   "
48500|NCT02422225|"~     The primary objective of this study is to investigate whether the dual transcranial direct~     current stimulation(tDCS) improves the swallowing function of stroke patients.~   "
48501|NCT02422212|"~     Introduction: According to the National Health and Nutrition Examination Survey 2009-2010,~     78 million American adults are obese. Bariatric surgery can provide for a sustained~     long-term weight loss and the metabolic change caused by the surgery seems to be the main~     cause of this loss. Cross-sectional, prospective and experimental studies, carried out~     during the post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an~     increase of over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a~     specific component of energy expenditure) when compared with obese patients. However,~     despite this metabolic improvement, 20-50% of the patients can suffer weight regain about 2~     years after surgery. So one question whether such metabolic benefits remain active following~     post-operative weight regain, or if the disappearance or decrease of these metabolic~     benefits may be seen as causes of this weight regain.~      Objective:To evaluate whether there are DIT differences between patients who maintained~     weight loss and those who regained weight in the late postoperative (postop) period of RYGBP~     and those who continue with preoperative (preop) obesity.~   "
48502|NCT02422199|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.~     This study is a randomized, multi-center, multinational, open-label, active-controlled,~     parallel design study of the combination of pyrotinib plus capecitabine versus the~     combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received~     anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use~     of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:~        -  Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)~        -  Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients~          will receive either arm of therapy until the occurrence of death, disease progression,~          unacceptable toxicity, or other specified withdrawal criterion.~   "
48503|NCT02422186|"~     The purpose of this study is to evaluate the efficacy and safety of switching elderly~     participants with treatment-resistant depression (TRD) from a prior antidepressant treatment~     (to which they have not responded) to either intranasal esketamine plus a new oral~     antidepressant or switching to a new oral antidepressant plus intranasal placebo.~   "
48504|NCT02422173|"~     Transcranial direct current stimulation (tDCS) has shown promising results in the modulation~     of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose~     of this study was to compare the effectiveness of three different montages of tDCS (anodal,~     cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in~     acute stroke patients.~   "
48505|NCT02422160|"~     The investigators have developed an image analysis method that can predict the likelihood~     that a patient with age related macular degeneration (AMD) will progress within 1 year,~     based on computerized analysis of optical coherence tomography (OCT) images that are~     routinely acquired in clinical practice on each patient visit to the ophthalmologist. The~     investigators' goal is to evaluate whether this method will improve the ability to detect~     AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories~     and having patients come back for follow up based on those categories.~   "
48506|NCT02422147|"~     This is a registry that will maintain prospective data on the clinical outcomes of all~     patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.~   "
48507|NCT02422134|"~     It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been~     found naturally in reproductive tract so our target is to test its effect if added to embryo~     transfer medium.~   "
48508|NCT02422121|"~     The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1~     will be measured after an inhaled allergen challenge at baseline and again after 21 days of~     treatment.~   "
48522|NCT02421939|"~     The purpose of this study is to determine the clinical benefit of ASP2215 therapy in~     patients with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are~     refractory to or have relapsed after first-line AML therapy as shown with overall survival~     compared to salvage chemotherapy.~      This study will also determine the overall efficacy in event-free survival (EFS) and~     complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.~   "
48728|NCT02419261|"~     Assessment of sensory and motor blockade of adductor canal blockade performed for anterior~     cruciate ligament repair in comparison with femoral nerve blockade.~   "
48729|NCT02419248|"~     Check the safety under normal conditions of use through the verification of emergence signs~     of irritability and sensitisation of the genital mucosa.~   "
48509|NCT02422108|"~     The receptor activator of NF-kB ligand (RANKL) system is considered important for bone~     homeostasis and comprises three important factors. RANKL exist in three isoforms but the~     predominant function is mediated by the transmembrane ligand that binds to a specific~     receptor (receptor activator of NF-KB (RANK)) on a neighbour cell that subsequently~     activates NFKB and regulates cell cycle OPG is an endogenous secreted protein that binds~     RANKL and inhibits its signalling.~      Thus, the RANK/RANKL system is vital for activation of the bone resorbing cells~     (osteoclasts). In bone the bone synthesizing cells (osteoblasts) express RANKL that signals~     to RANK on the immature osteoclasts. This induces proliferation and activation of the cells~     they start to proliferate and resorp bone. OPG is produced by somatic cells in the bone and~     this production is regulated by sex hormones, TGF-B and various other substances. Today a~     human made recombinant antibody against RANKL, Denosumab is used to treat osteoporosis as it~     inhibits RANKL signalling and thus causes less bone resorption in humans.~      RANKL, RANK and OPG are expressed in the testis and this pathway appears to be a novel~     regulator of germ cell proliferation. Decreased semen quality is a major factor of male~     infertility. Semen quality is a measure of the ability of the sperm to accomplish~     fertilization. Evaluation of male fertility potential is today basically conducted through~     semen analysis. There is no treatment for men with no sperm in the ejaculate and there exist~     no drug that can increase sperm counts.Therefore, drugs that can lower RANKL~     expression/activity for instance an antibody against RANKL such as Denosumab may be used for~     this new indication: A new treatment option of infertile men with impaired semen quality.~   "
48510|NCT02422095|"~     This registry is developed to assess the outcomes of patients undergoing EUS of pancreatic~     cyst lesions as is provides data that will enable quality control of the examination~     performed.~   "
48511|NCT02422082|"~     Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has~     probiotic, health-promoting effects in both adults and children, and is safe for human~     consumption. Animal models indicate that treatment with L. reuteri has positive effects on~     bone metabolism and bone density. In other animal models of diabetes and the metabolic~     syndrome, positive effects on blood glucose and weight have been reported. The present~     double-blind, placebo-controlled, randomized study is designed to investigate if dietary~     supplementation with L. reuteri twice daily for 12 months has any effect on bone density,~     body composition, inflammation, or metabolic and endocrine markers in elderly women with~     osteopenia.~   "
48512|NCT02422069|"~     This observational study will provide an opportunity to document local patterns of~     susceptibility, patient profile, and usefulness of screening in postmenopausal patients~     coming to gynecology outpatient clinics in Pakistan. This will also capture the initial~     management of PMO in diagnosed patients. The information gathered will serve as a foundation~     for developing national guidelines on screening and management of PMO in Pakistan.~   "
48513|NCT02422056|"~     Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding~     in palatoplasty.~   "
48514|NCT02422043|"~     The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to~     make the teenager to self manage their disease and its treatment. Based on social cognitive~     theory Bandura, the effects of educational activities for TVE should lead to the~     strengthening of self-efficacy, coupled with other socio-cognitive factors favoring~     adherence of teenager and a better quality of life. However, socio-cognitive determinants~     and mechanisms to achieve this, implemented by adolescents during and after the ETP program,~     are not sufficiently documented.~   "
48515|NCT02422030|"~     The purpose of this study is to evaluate the pharmacokinetic interaction between~     Atorvastatin and Fenofibric acid.~   "
48516|NCT02422017|"~     Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their~     management. At the origin of high health costs and strong repercussions on quality of life~     for patients, they require long management and may be subject to possible complications.~      In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.~      Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The~     purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous~     ulcers with topical timolol.~   "
48517|NCT02422004|"~     The overall aim of this project is to investigate the healing processes of human tendon~     after suturing a ruptured Achilles tendon, and more specifically to determine the optimal~     loading pattern of the tendon during the rehabilitation period to ensure complete and good~     recovery of tendon structure and function. The investigators hypothesize that restricting~     early weight bearing and only allowing for passive stretching in the early phase of tendon~     healing will ensure better tissue regeneration and thereby prevent chronic tendon elongation~     and improve tendon tissue recovery and the clinical outcome.~   "
48518|NCT02421991|"~     The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT)~     implementation outcomes are at least as good as those of traditional cognitive behavioral~     therapy (CBT).~   "
48519|NCT02421978|"~     The purpose of this study is to try and provide data linking the impact of increased~     inflammatory cytokines as a result of chemotherapy and their relationship with increased~     levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer~     patients. The investigators will use neuropsychiatric assessments, blood sampling and~     Magnetic Resonance Spectroscopy (MRS) to collect study data.~   "
48520|NCT02421965|"~     The study is a three year research project whose aims are to evaluate the willingness of~     individuals with serious mental illness to initiate the two illness self-management~     interventions- WRAP or FOCUS, to examine and compare participant engagement, satisfaction,~     and outcomes (symptoms, recovery, quality of life) in the two interventions.~   "
48521|NCT02421952|"~     Pediatric research in the management of nausea has been limited by the absence of a reliable~     method to quantify the intensity of this subjective symptom. In adults, the visual analog~     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young~     children. By default the most common objective outcome measure used in pediatric studies has~     been the incidence and number of emetic episodes. This measure, however, correlates poorly~     with the somatic subjective symptom of nausea.~   "
49321|NCT02411539|"~     The purpose of this study is to evaluate the safety, tolerability, and effect of an~     experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults~     infected with HIV who are receiving antiretroviral therapy (ART).~   "
48525|NCT02421900|"~     The purpose of this study is 1) to characterize T-cell response in patients with atrial~     fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency~     catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling~     of T cells from patients with atrial fibrillation will performed. Next the difference of~     T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally~     the changes of T-cell response and cytokines after radio-frequency catheter ablation of~     atrial fibrillation will be assessed.~   "
48526|NCT02421887|"~     The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether~     treatment of infertile males with an antioxidant formulation improves male fertility. The~     central hypothesis is that treatment of infertile males with antioxidants will improve sperm~     structure and function, resulting in higher fertilization rates and improved embryo~     development, leading to higher pregnancy and live birth rates. Findings from this research~     will be significant in that they will likely lead to an effective, non-hormonal treatment~     modality for male infertility. An effective treatment for men would also reduce the~     treatment burden on the female partner, lower costs, and provide effective alternatives to~     couples with religious or ethical contraindications to ART (Assisted Reproductive~     Technology). If antioxidants do not improve pregnancy rates, but do improve sperm motility~     and DNA integrity, they could allow for couples with male factor infertility to use less~     intensive therapies such as intrauterine insemination. Male fertility specialists currently~     prescribe antioxidants based on the limited data supporting their use. A negative finding,~     lack of any benefit, would also alter current treatment of infertile males.~   "
48527|NCT02421874|"~     The purpose of this Phase II Small Business Technology Transfer (STTR) project is to~     complete development and evaluate usability and effectiveness of the Wraparound Team~     Monitoring System (Wrap-TMS), a web-based, electronic behavioral health information system~     (EBHIS) for the most widely implemented care coordination model in children's behavioral~     health, the wraparound process. Though wraparound is now considered evidence-based,~     implementation in the real world often fails to conform to standards of fidelity and/or use~     objective data to guide management, supervision, and clinical decision making. Availability~     of such a system will support efficiency, implementation quality and fidelity, and outcomes~     for youths enrolled in wraparound. Wrap-TMS features functionality for data entry,~     management, and basic reporting for the full array of data and information elements needed~     to manage an integrated care coordination initiative for youths with serious emotional and~     behavioral disorder (SEBD). In light of our success in Phase I, subsequent partnerships with~     federal agencies, and inquiries of interest from several states and over 20 provider and~     managed care organizations, in this Phase II STTR the investigators will complete~     development of Wrap-TMS, followed by a randomized controlled effectiveness study comparing~     n=25 wraparound facilitators who use Wrap-TMS serving n=100 families to 25 non-user~     facilitators serving 100 families on practitioner, implementation, and youth/family~     outcomes. The evaluation will test two primary hypotheses:~        1. Compared to facilitators in the control group, wraparound facilitators trained to use~          Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b)~          greater fidelity to the wraparound process; (c) higher self-reported teamwork, working~          alliance, and satisfaction with the intervention; and (d) more positive attitudes~          toward standardized assessment.~        2. Compared to the control group, parents of youths receiving services from facilitators~          trained to use TMS will report (a) greater goal clarity, (b) more data collection and~          use (c) greater satisfaction with services and progress, (d) better fidelity to~          wraparound, (e) more effective team functioning, (f) greater treatment alliance, and~          (f) better youth outcomes including greater progress and improved symptoms and~          functioning.~   "
48528|NCT02421861|"~     The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety~     management approach with patients who are critically ill and/or traumatically injured during~     intensive care hospitalization and (2) test whether this approach reduces anxiety and~     improves engagement in rehabilitation therapies, shortens duration of hospitalization, and~     improves psychological and quality of life outcomes.~   "
48529|NCT02421848|"~     Malnutrition due to liver disease is common, however, their detection is difficult. The~     parameters used for nutritional assessment in clinical practice have limited use in this~     patient population.~      From this perspective, this study proposes to develop predictive equations for body~     composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast~     and risk free, the BIA offers the additional advantage of low cost compared to other methods~     that assess body composition (BC).~      Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic~     of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.~      This pioneering study is of great clinical importance because malnutrition is a relevant~     factor in the prognosis of liver disease and there is not efficient method in clinical~     practice to properly assess the body composition in this population.~   "
48530|NCT02421835|"~     Hypertension affects about 30% of the United Kingdom population and is causally implicated~     in the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a~     poor diet and low levels of physical activity are all risk factors. Studies have shown that~     adherence to a Mediterranean diet is protective against hypertension and its associated~     morbidities; olive oil is believed to be a key beneficially bioactive component of that~     diet. As a source of lipids olive oil is an unremarkable blend of monounsaturated,~     polyunsaturated and saturated fatty acids; it is however rich in phenolic compounds,~     principally oleuropein and hydroxytyrosol, which may be of benefit to health. A recent~     randomised intervention trial in predominantly hypertensive volunteers showed that adherence~     to a Mediterranean diet supplemented with extra virgin olive oil, reduced blood pressure and~     other measures of cardiovascular disease risk. Olive phenolics can be extracted cheaply from~     the waste products of olive oil manufacture, such as the plant leaf and these are used as~     dietary supplements. In intervention studies in hypertensive or borderline hypertensive~     patients, olive leaf extract consumption has been shown to reduce blood pressure.~      Another intervention with established efficacy for improving blood pressure is to increase~     physical activity. The 'Start Active, Stay Active', Chief Medical Officers report on~     physical activity recommends that adults achieve 150 minutes of moderate intensity physical~     activity per week, while data in that report suggest that fewer than 40% of adult men and~     30% of adult women achieve these targets. Adherence to the physical activity guidelines may~     in fact be much worse in sub-sections of the population at higher risk of hypertension.~      From a public health perspective, holistic guidelines for the prevention of hypertension, or~     its early diagnosis and management, based around a healthy diet and lifestyle are preferable~     to pharmaceutical intervention. Lifestyle interventions are economically favourable and they~     come with fewer side effects and perhaps wider health benefits than antihypertensive drugs.~      The aim of the study is to evidence the synergistic benefits of consuming plant (and~     specifically olive) phenolics alongside achieving the recommended guidelines for physical~     activity in individuals with elevated blood pressure.~   "
48531|NCT02421822|"~     The purpose of this study is to test the Fitwits office tool and games with 6-9 year old~     children and their parents to: 1) assist parent-child dyad with correct BMI status~     identification and understanding; 2) address nutrition, portion size, and activity cues;~     and, 3) track BMI trajectory over 12-month period.~   "
48650|NCT02420275|"~     After a brain injury (BI) , patients complain in particular about sequel fatigue. This~     symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of~     life, reeducation and occupational reintegration, and persists often at a distance of the~     accident. The investigators' hypothesis is that patients who presented a severe BI could~     benefit from a treatment by withe blue enriched bright light in order to improve fatigue and~     quality of life.~   "
49322|NCT02411526|"~     This is an open-label, multiple dose, PK and safety study in patients with chronic, stable~     schizophrenia or schizoaffective disorder.~   "
48532|NCT02421809|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of oral~     lesions in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients~     and search for correlations with other clinical characteristics. This prospective~     observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like~     symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine~     and at the Gastroenterology Units of the University of Palermo. Elimination diet and~     double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All~     subjects underwent oral examination to assess the presence or not of oral soft and hard~     tissue lesions potentially associated to NCWS and CD.~   "
48533|NCT02421796|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of low bone~     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of malnutrition in~     NCWS patients and search for correlations with other clinical characteristics. This~     prospective observation study will include 90 NCWS patients with irritable bowel syndrome~     (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the~     Internal Medicine and at the Gastroenterology Units of the University of Palermo.~     Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS~     diagnosis. All subjects underwent nutritional parameters measurement, duodenal histology,~     Human Leucocyte Antigen (HLA) DQ typing and body mass index (BMI) evaluation.~   "
48534|NCT02421783|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of low bone~     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS~     patients and search for correlations with other clinical characteristics.~      This prospective observation study will include 90 NCWS patients with irritable bowel~     syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at~     the Internal Medicine and at the Gastroenterology Units of the University of Palermo.~     Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS~     diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA),~     duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI)~     evaluation and assessment for daily calcium intake.~   "
48535|NCT02421770|"~     Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by~     outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is~     unknown, the pathogenesis of OLP is known to involve an immune disorder, with epithelial~     damage caused by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by~     different types of lesions - papular, reticular and in the form of plaques - that can~     alternate with erosive and/or ulcerative areas. A variety of treatments have been proposed~     for OLP: topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine,~     tacrolimus, pimecrolimus, photochemotherapy and surgery. Patients with symptomatic OLP often~     require intensive therapy to reduce the signs and symptoms. The disease can produce~     considerable morbidity and alter patient quality of life, particularly in the presence of~     ulcerative lesions.~      There is no fully resolutive and effective treatment - the management strategy focusing on~     the use of drugs that counter tissue inflammation and the underlying immunological~     mechanisms. The main inconvenience of these treatments is represented by the side effects~     they usually produce.~   "
48536|NCT02421757|"~     This is a single-site, randomized, Single-blinded, placebo-controlled, trial of~     Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will~     be applied locally to the back in the location of a patient's pain.~   "
48537|NCT02421744|"~     Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training~     followed by a structured 3 months home exercise program would have higher benefits compared~     to a delayed-treatment group as control in people with multiple sclerosis and mild to~     moderate gait impairment.~      Our secondary hypothesis is that there could be retention of clinical gains in subjects that~     underwent TOCT plus structured 3 months home exercise program.~   "
48538|NCT02421731|"~     Gait disabilities affect personal activities and quality of life of progressive multiple~     sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of~     walking movements and imitation of a nearly normal gait pattern during treadmill training at~     a higher speed has been developed and recently introduced in clinical settings. However,~     until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a~     group of stroke, spinal cord injury and MS subjects.~      In addition, the training-induced neural and biological changes potentially related to the~     mechanisms of recovery remain undefined.~      The primary aims of this study are:~      to test the feasibility of RAGT in a group of progressive severely disabled MS patients and~     to test the hypothesis that this intensive intervention could have higher benefit, compared~     with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot~     Walk (T25FW)~      The secondary aims of this study are:~      to determine whether fatigue, Quality of life, balance and locomotor function are improved~     by RAGT; to determine whether gait training influences markers of plasticity including~     clinical and circulating biomarkers to search for a possible correlation between clinical~     outcomes and clinical and circulating biomarkers~   "
48539|NCT02421718|"~     Motive:~      In order to improve the treatment technique, a comprehensive follow-up program is needed to~     obtain all relevant patient, treatment and toxicity data from lung cancer patients.~      Goal:~      To set-up and maintain a database containing treatment results in terms of tumor control,~     side effects, complications and patient-reported quality of life.~      A standard database of patients receiving photon treatment will be created. These data are~     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for~     both tumor control and toxicity after radio (chemo) therapy that can later be used for~     selecting patients for proton treatment.~   "
48540|NCT02421705|"~     Aim:~      More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European~     research project.~   "
48651|NCT02420262|"~     This trial is conducted globally. The aim of this trial is to compare efficacy and safety of~     insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with~     metformin in subjects with type 2 diabetes mellitus.~   "
48541|NCT02421692|"~     Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing~     facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care~     to maximize rehabilitation potential for return to prior level of function and reduce the~     risk of adverse events in older adults. However despite a substantial increase in spending~     on SNF services and minimal change in complexity of the caseload, 68% of patients are below~     their pre-hospitalization level of function at discharge, 25% return to the community, and~     18% are hospitalized. This may be partially explained by current SNF approaches to patient~     care which foster inactivity and participation in low intensity rehabilitation interventions~     (preliminary data). Both inactivity and low-intensity interventions may perpetuate further~     functional decline or impede maximal recovery. The serious implication of risk with~     functional decline is exemplified by studies which have shown declines in physical function~     can increase the risk of being re-hospitalized six-fold and may infer other long term~     effects such as increased risk for mortality, morbidity, and institutionalization. Muscle~     weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed~     to this acute decline in function. However current rehabilitation strategies in SNFs do not~     promote adequate dose and mode of interventions to induce beneficial systemic adaptations,~     perhaps due to the lack of evidence on effective rehabilitation protocols for this~     medically-complex population. Therefore, the investigators have designed an rehabilitation~     program, which uniquely integrates principles of physiologic tissue overload with~     strengthening and functional interventions for greater gains in physical function. Data will~     be collected on the first cohort of patients who cycle through a SNF during Stage 1, in~     which usual care occurs (5 months). Then, staff training on progressive rehabilitation~     interventions will occur over 2 months. Finally, data will be collected on a second cohort~     of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is~     implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average~     length of stay ~21 days), 2 different cohorts of patients will be studied and the analysis~     will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical~     function will be assessed on all eligible patients at admission and discharge from SNF.~     Therapists will be assessed on adherence to the protocol through documentation audits and~     use of on-site observational checklist. Acceptability of the intervention by the patients~     will be assessed by a patient satisfaction survey. Any adverse events will be obtained from~     the medical record and documented. The discharge location of all patients will be~     documented.~   "
48542|NCT02421679|"~     This is a 12-week, multicenter, open-label extension study to evaluate the safety and~     efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD~     or related condition. Patients recruited into this trial are those who have successfully~     completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made~     aware of the therapy they received during the double-blind study.~   "
48543|NCT02421666|"~     Asian Americans have the highest rates of chronic hepatitis B virus (HBV) infection (CHB) in~     the United States.Those with CHB often report that they feel well even though they are at~     high risk for complications. Because of the high incidence and prevalence of CHB, patients~     at high risk need to be tested every 6 to 12 months for early signs of liver problems.This~     study will answer critical questions for Asian Americans with CHB about improving timely~     testing. Using a randomization process, 500 of these patients will receive either the~     Patient Navigator plus Mobile Phone Text Messaging Intervention (PNMI) or standard care. At~     patients' entry into the study, 6 months, and 12 months, information will be~     collected.Patient navigators representing Asian cultures will receive a thorough HBV~     training. PNMI patients will receive three patient navigator led education sessions and text~     messages over mobile phone. Patients, patient advocates, physicians, and researchers of~     Center for Asian Health (CAH) will be active study partners.~      Patient Outcomes: The investigators expect to find better health outcomes and lower HBV~     health gaps, as measured by the number of patients:~        1. getting doctor-recommended tests at 6 and 12 months;~        2. getting doctor-recommended HBV care;~        3. improved HBV knowledge, a better quality of life, social support, and coping skills;~          and~        4. having fewer barriers and less anxiety.~   "
48544|NCT02421653|"~     In this study, two intervention strategies to address iodine deficiency and prevent iodine~     deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate~     iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.~   "
48545|NCT02421640|"~     This is a Phase II trial to study the effectiveness and security of cisplatin concurrent~     chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in~     treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.~   "
48546|NCT02421627|"~     To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel~     syndrome and evaluation by Magnetic Resonance Imaging (MRI).~   "
48547|NCT02421614|"~     This study aimed to investigate the effect of enteral feeding's macronutrient composition on~     inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients~     with acute respiratory failure. In this double-blind randomized control trial, 42 patients~     of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral~     feeding, will be randomly assigned to three groups of 14 each. First Intervention group;~     high-protein low-carbohydrate diet with high olive oil, the second intervention group;~     high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen~     formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP),~     Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well~     as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be~     evaluated.~   "
48548|NCT02421601|"~     The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in~     patients with lumbar disc herniation.~   "
48549|NCT02421588|"~     Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the~     activity and safety of PM01183 versus PLD or topotecan as control arm in patients with~     platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the~     experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).~   "
48550|NCT02421575|"~     This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with~     prostate cancer who are undergoing surgery or active surveillance. Autophagy is a process in~     which cells break down some parts of themselves to stay alive during times of stress, such~     as starvation. This may allow cancer cells to survive damage from chemotherapy.~     Hydroxychloroquine may block this process from happening.~   "
48551|NCT02421562|"~     Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia~     techniques, and this new tool will translate into a reduction of procedural distress and~     pain in their patients, thereby opening the way to larger clinical trials in various~     pediatric settings.~   "
48679|NCT02419898|"~     The aim of this feasibility study is to test recruitment of participants into Phase 1 of the~     study and then the re-recruitment and retention of participants in Phase 2 of the study. The~     investigators will also be assessing the acceptability of recruitment strategy and data~     collection to participants.~      The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and~     psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological~     outcomes will all be examined.~   "
48552|NCT02421549|"~     A retrospective, multi-center, proof-of-concept study to evaluate the use of remote~     monitoring in rural emergency departments to decrease time to treatment decision for~     pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The~     purpose of the study is to determine if utilization of remote monitoring technology in a~     rural emergency department may improve patient care.~      Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in~     the remote monitoring group comprised of patients with SJM devices compatible with the~     unpaired transmitter and 100 patients will be in the usual medical care group comprised of~     patients with SJM devices that are not compatible with the unpaired transmitter or that have~     a competitor's device.~   "
48553|NCT02421536|"~     This research is being done to evaluate whether or not a customized version of the VibrentTM~     (formerly FitNinjaTM) mobile app is a feasible way to help people manage and control the~     pain from radiation sores (also referred to as mucositis) when treating head and neck~     cancers with radiation. The mobile app will be designed to help people better understand the~     pain from the radiation sores and how to better use their medications especially when they~     are away from the hospital.~   "
48554|NCT02421523|"~     Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle~     breakdown, weakness, and eventual death. Over the last 40 years parents have received little~     guidance on the potential of exercise as a therapeutic strategy to maintain muscle function.~     It is well known that high intensity exercise and eccentric contractions can result in~     muscle damage in dystrophic muscle, yet the absence of muscle loading will conversely result~     in muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy~     supports earlier studies that resistance exercise may have beneficial effects for~     maintenance of muscle mass in dystrophic muscle. However, careful and systematic~     investigation into the safety and feasibility of resistance exercise is needed to consider~     its implementation in boys with DMD.~      The goal of this project is to assess the safety and feasibility of a home based mild to~     moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy~     (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests~     that strengthening exercise may be beneficial for these children, but this area has not been~     adequately explored using human subjects. The results of this study should provide~     information to assist in the development of scientifically based recommendations concerning~     optimal exercise parameters for patients with DMD.~   "
48555|NCT02421510|"~     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin high dose~     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when~     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate~     glycemic control with insulin therapy.~   "
48556|NCT02421497|"~     Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has~     the potential to improve patient health care and management. The overall objective of~     proposed project is to:~        1. develop, customize, and optimize anatomic and functional MRI methods,~        2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and~        3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the~          progression of renal dysfunction.~      In addition to direct studies of the kidney, brain MRI studies will also be performed to~     identify the cerebrovascular and cognitive effects of chronic renal function deficiency and~     medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have~     similar vascular bed, and both are susceptible to vascular injury, which provides the~     pathological basis for the widely recognized association of reduced renal function with~     prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in~     the brain will be applied to explore the origins for widely observed CVDs and prevalent~     cognitive impairment (CI) in kidney disease patients.~   "
48557|NCT02421484|"~     This is a Phase I open label dose escalation trial of human allogeneic bone marrow derived~     mesenchymal stromal cells (MSCs) for the treatment of septic shock. The main purpose of the~     study is to assess the safety of MSCs in patients with septic shock.~   "
48558|NCT02421471|"~     This study is a mandatory post launch observational study in South Korea of 3.000 patients~     receiving treatment for the first time with a new medicinal product, ingenol mebutate gel~     (Picato®), approved for topical treatment of actinic keratosis.~      Each patient is observed for 8 weeks after treatment completion.~   "
48559|NCT02421458|"~     RCT to compare two radiation schemes for palliative HeadNeck cancer~   "
48560|NCT02421445|"~     This is an observational study to characterize human milk of mothers delivering term SGA and~     term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6~     months postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be~     randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment~     period for the study in India is for 6 months.~   "
48561|NCT02421432|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision in difficult case.~      Difficult case is defined as below;~      - If any one of the following (1 or 2 or 3)~        1. BMI: 30 or more~        2. Tumor size: more than 7cm in long diameter~        3. CRM: mesorectal fascia involvement or less than 1 mm on MRI~   "
48562|NCT02421419|"~     This research is being done to compare pain relief and efficacy of trigger finger injection~     using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus~     corticosteroid/saline combination.~   "
48563|NCT02421406|"~     The goal of this project is to determine whether an Internet-based weight loss program will~     lead to weight loss and improvements in cardiovascular disease risk factors in people living~     with HIV.~   "
48564|NCT02421393|"~     Type 2 diabetes mellitus (T2DM) is associated with increased fracture risk despite normal to~     increased bone mass, thus suggesting poor bone quality. This study is aimed at weighing the~     effect of an exercise intervention program on parameters of bone quality in patients with~     type 2 diabetes mellitus. Two hundred patients with T2DM will be randomized to supervised~     exercise training on top of standard care (exercise, EXE, group; n=100) versus standard care~     (control, CON, group; n=100) for 24 months.~   "
49323|NCT02411513|"~     The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as~     an acute treatment for a migraine attack. This open clinical trial will study the acute~     treatment of migraine using the Cefaly® device, prior to development of a sham-controlled~     trial.~   "
48565|NCT02421380|"~     The purpose of the study is to test a new approach to see if the test results can be~     reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient.~     The study will explore the use of an imaging agent called hyperpolarized [1-13C] pyruvate~     (HP) with MRI scans. (MRI) is a technique that takes pictures of the body's organs using a~     magnetic field and radiofrequency waves that cannot be felt. In order to accomplish the goal~     of the study the patient will have two hyperpolarized MRI scans to assess if scans can be~     reproduced. The hyperpolarized MRI scans will be compared with the pathological results of~     the surgery to see if the hyperpolarized MRI provides additional information regarding~     disease metabolism.~   "
48566|NCT02421367|"~     This study is being conducted to evaluate the safety and immunogenicity and antibody~     persistence of the candidate dengue vaccine.~   "
48567|NCT02421354|"~     The goal of this clinical research study is to learn if nivolumab can help to control MF.~     The safety of this drug will also be studied.~   "
48568|NCT02421341|"~     This study is being done because the investigators are trying to understand how feedback~     from the muscles can influence your blood pressure and breathing during exercise, and if the~     investigators can reduce this response in heart failure patients. The investigators are also~     trying to determine ways to improve tolerance to exercise in heart failure patients.~   "
48569|NCT02421328|"~     This is a prospective, randomized crossover study to recognize the effects of nasal~     continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula~     (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm~     infants.~   "
48570|NCT02421315|"~     The purpose of this study is to examine the brain functioning of children and adolescent~     with OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.~   "
48571|NCT02421302|"~     This will be cohort study design with both qualitative and quantitative methods of data~     collection. The investigators are aiming to study 64 HIV positive children as healthy~     controls either initiating ART or already on ART and 86 malnourished HIV infected children~     on ART or naïve initiating ART and RUTF aged between 6 months to 12 years. Primary carers~     will be asked to provide informed consent whereby the children and primary carers will be~     enrolled into the study and followed up for 12 weeks.~   "
48572|NCT02421289|"~     Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV~     metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse~     event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the~     proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between~     patient who did CYP 2B6 guided EFV dose and who did not.~   "
48573|NCT02421276|"~     This study plans to learn more about Down syndrome. The investigators think there is a~     different level of the AIRE gene in individuals with Down syndrome. The investigators think~     that the AIRE gene level can provide more insight about depressed immune cell function in~     individuals with Down syndrome. Patients are being asked to be in this research study~     because the investigators want to see if their blood contains more of less of the AIRE gene.~   "
48574|NCT02421263|"~     The current protocol is a pilot study of the effects and possible utility of~     psilocybin-facilitated experiences for professional religious leaders. We hypothesize that~     religious professionals, given their interests, training, and life experience, will be able~     to make nuanced discriminations of their psilocybin experiences, thus contributing to the~     scientific understanding of mystical-type experience. As we better characterize the~     phenomenology of psilocybin-induced mystical experiences, we may apply this knowledge to~     improve potential treatment studies in the future. A primary objective is to investigate~     changes in psychological functioning, spirituality, health, well-being, prosocial attitudes~     and behavior in professional religious leaders that may occur after receiving psilocybin~     under supportive conditions. A secondary objective is to determine whether participants who~     report having had the strongest mystical-type effects during psilocybin sessions will show~     the largest positive changes in the Interim Questionnaire.~   "
48575|NCT02421250|"~     The study is a clinical trial to determine whether more efficient medical and operational~     outcomes can be achieved with using the new SpHb monitoring during triage in the emergency~     room setting. The investigators also evaluate the accuracy of the measurements of the SpHb~     device by Maximo versus the gold standard of central hospital laboratory value. In addition,~     the investigators will assess patient satisfaction with the tool.~   "
48576|NCT02421237|"~     The purpose of the present study is to build upon the investigators' previous exploratory~     intervention development study by conducting an adequately-powered, randomized controlled~     trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with~     schizophrenia-spectrum disorders.~   "
48577|NCT02421224|"~     The investigators will conduct a cluster randomized controlled trial of several behavioral~     interventions for smoking cessation among a sample of employees at large workplaces in the~     Bangkok metropolitan area. The study aims to test the impacts of different incentive~     structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The~     interventions are designed to elucidate certain principles from the field of behavioral~     economics.~   "
48578|NCT02421211|"~     The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir~     and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and~     ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV)~     genotype 1 infection.~   "
48597|NCT02420964|"~     The study will be a prospective randomized trial involving human subjects. The study~     population will consist of all infertility patients presenting to the Carolinas Medical~     Center Women's Institute who will require injectable use.~      Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded~     from the study.~      Independent Variables: The independent variable is the random assignment of each participant~     to receive either web-based or one on one teaching.~      Outcome Variables: The primary outcome variable is the level of knowledge after the~     intervention. Secondary outcome variables include level of satisfaction with education,~     preference of educational method, and time required to teach.~      Confounding Variables: Potentially confounding variables include age, race, and prior~     experience with web-based teaching.~   "
49324|NCT02411500|"~     The primary objective of this study is to evaluate the pharmacokinetics of various TRV734~     formulations in healthy male subjects.~   "
48579|NCT02421198|"~     Over one-third of children and adolescents are overweight and nearly 1 in 5 of them are~     obese. Metabolic syndrome, a strong predictor of Type 2 diabetes (T2D) and cardiovascular~     disease (CVD), occurs in up to 44% of obese youth, foreshadowing greater prevalence and~     earlier onset of T2D. Without effective interventions, diabesity will worsen, T2D~     prevalence will increase, and adults will face its consequences at younger ages. Given the~     strong association between obesity and chronic disease risk factors in youth, the~     investigators contend T2D prevention (and CVD prevention) is akin to weight control and~     obesity prevention. The objective of the proposed project is to develop a family-centered,~     community-based program for T2D prevention in peripubertal (9- to 12-year-old) youth. Using~     participatory methods, the investigators intend to adapt the successful adult-focused YMCA~     Diabetes Prevention Program (YDPP) for youth and families and assess the feasibility,~     participant acceptance of and adherence to the YFDPP using two delivery formats: a 12-week~     YMCA-based face-to-face program and a 12-week combined face-to-face plus mobile device-based~     program. The proposed study will test the investigators premise that delivery with~     technology can reduce participant perceived burden, improve adherence, and lead to improved~     anthropometric (height, weight and BMI and waist circumference), behavioral (diet and~     physical activity) and physiological outcomes (fasting insulin, glucose, lipid, blood~     pressure). The investigators will use the resulting data to design an appropriately powered~     full-scale trial. The importance of the proposed study is underscored both by the statistics~     cited above and the recent call for proposals to translate efficacious clinical~     interventions into effective community programs for youth. The potential impact of the~     proposed intervention is great in that the program will be delivered by paraprofessionals~     from the community without university researchers; significant in that it targets a major~     public health challenge in children and includes assessment of objective behavioral and~     clinical data; and innovative in that it focuses on an at-risk population, takes place at a~     popular, accessible community venue, and uses mobile technologies to extend reach and~     increase engagement of youth and families with intervention content. The long-term goal is~     to create a scalable, replicable, and sustainable program that overcomes existing barriers~     to implementation and dissemination of evidence-based, research-proven diabetes prevention~     programs to youth and families, thereby improving population health.~   "
48580|NCT02421185|"~     The purpose of this study is to determine recommended Phase 2 dose [RP2D]) and the objective~     response rate of JNJ-42756493 (erdafitinib) in advanced hepatocellular carcinoma (HCC)~     participants with fibroblast growth factor (FGF) 19 amplification.~   "
48581|NCT02421172|"~     This is a randomized, double blind, multicenter study in patients with moderate to severe~     chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of~     multiple doses of CJM112 in comparison to placebo. The study has two periods to explore~     preliminary dose effects.~   "
48582|NCT02421159|"~     The Brooklyn Community United (BCU) study is a supplement to the main research study titled~     Peer Driven Intervention to Seek, Test, & Treat Heterosexuals at High Risk for HIV. The~     main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#:~     11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection~     (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation~     (CTTN-RDS)).~      HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7%~     in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%,~     35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with~     HIV in the VBS sample.~      The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with~     undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central~     Brooklyn.~      The supplement study hypotheses are:~      (H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key~     socio-demographic characteristics across the samples, RDS-ASTN participants will have less~     HIV testing experience.~      (H2) Controlling for potential differences on key socio-demographic characteristics across~     the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS~     and RDS-CTTN.~      (H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will~     engage in the Treat and Retain intervention phase.~      (H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%),~     all of whom will be HIV infected, will be linked to care within 3 months.~   "
48583|NCT02421146|"~     The purpose of this project is to examine brain function before, during, and after the~     administration of tDCS (Transcranial Direct Current Stimulation). The brain can perform its~     job well or poorly depending on many things. The investigators will be using computer tasks~     and paper and pencil questionnaires to measure the relationship between brain performance~     and the administration of tDCS. In addition, the study team will be using functional~     magnetic resonance imaging (fMRI) and related imaging techniques to see how your brain works~     and compare it with the results we collected from the paper and pencil questionnaires. This~     study will enroll both schizophrenia patients as well as healthy volunteers without any~     major psychiatric disorder or physical illness.~   "
48584|NCT02421133|"~     In France, it has be estimated that the hospital readmission rate within 30 days of patients~     aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is~     evidence that interventions bridging the transition from hospital to home involving a~     dedicated professional (usually nurses) would be most effective in reducing the risk of~     readmission, but the level of evidence of current studies is low. Our study aims to assess~     the impact of a program of transitional care from hospital to home for people of 75 years~     old or more admitted to acute care.~   "
48585|NCT02421120|"~     There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered~     antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly~     approved broad spectrum intravenous antibiotic, which has potent in vitro activity against~     multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF~     pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of~     ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one~     of 4 participating hospitals in the US. Patients will remain on standard of care IV~     antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood~     will be sampled after the final dose to determine concentrations and pharmacokinetics of~     ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day~     study.~   "
48611|NCT02420782|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy~     male and female subjects. 1 cohort (elderly) receives also a midazolam dosing.~      This study will also explore the effect of itraconazole (another drug) on the PK of ASP6282,~     as well as to evaluate the safety and tolerability of ASP6282 alone and in combination with~     itraconazole in healthy male and female subjects.~      Also, this study is to evaluate the PD and PK effects of single oral doses of ASP6282 on~     pilocarpine-induced salivation and pupil diameter in healthy nonelderly male and female~     subjects.~   "
48586|NCT02421107|"~     The company who have developed the GlySure product have previously carried out a study to be~     able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels.~     This was done with patients in the intensive care unit (ICU) after heart surgery.~      The company now want to confirm that the GlySure product is accurate at measuring blood~     glucose levels on all patients who stay in the ICU.~      This clinical study requires 40 patients and is to check the safety of a continuous Glucose~     Monitoring System (GlySure) and it's performance in comparison to separate individual blood~     glucose testing using a hand held blood tester called i-STAT. Each patient must be in the~     study for at least 36 hours.~      The main benefit of continuous blood glucose monitoring is that it gives a true picture of~     the glucose status of a patient and this can potentially help avoid the glucose level~     dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can~     intervene based on `real-time` data on the glucose levels.~      In this study patient treatment is not dictated by the data measured during the study.~     Clinicians are blind to the results on the GlySure monitor.~   "
48587|NCT02421094|"~     A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial~     to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the~     Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced~     Fibrosis~   "
48588|NCT02421081|"~     The radial and ulnar artery injuries related with the wrist cut are frequently encountered.~     There are many factors which are effective on the improvement of these arterial structures~     was repaired with microsurgical techniques. Recently has begun to focus on neointimal~     thickening and endothelialization of the role in vascular healing and maturation made on~     histopathological study. In this study, the radial and ulnar artery laceration repair~     healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of~     the effect of the distribution of lymphoid cells has been investigated. The investigators~     think that; thus by demonstrating the positive impact that may arise; autologous endothelial~     progenitor cells which are obtained in patients; continuation of anastomotic patency~     undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also~     ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The~     investigators believe could be used for the reimplanted tissue in the limb breakage ensuring~     that survive.~   "
48589|NCT02421068|"~     This study will provide information on the pharmacokinetics, safety and effectiveness of~     off--label drugs used in critically ill premature infants: doxapram, fentanyl, midazolam,~     paracetamol, phenobarbital, sildenafil, levetiracetam, ibuprofen and fluconazole. PK/PD~     analysis with NONMEM (non-linear mixed effects modelling) will result in (adapted) dosage~     guidelines, thus contributing towards an improvement in the quality of care and cost~     efficiency. Furthermore the development of Dried Blood Spot (DBS) analysis is investigated~     for these drugs as a minimally invasive method for conventional patient care and to perform~     pharmacological studies in children. The adapted dosage guidelines will be implemented~     directly into clinical practice in collaboration with the NKFK. Therefore the study is~     designed as an observational multicenter study to be able to collect sufficient data for the~     drugs of interest.~   "
48590|NCT02421055|"~     Recent studies have shown that bacteria within the gut play an important role in diabetes~     improvement after bariatric (weight-loss) surgery. Bariatric surgery fundamentally changes~     the environment within the gut, which results in changes to the makeup of the trillions of~     bacteria living within it. These changes in the gut bacteria can affect the body in a number~     of complex ways, which we are only just beginning to understand. For example, gut bacteria~     breakdown food we are unable to absorb ourselves, leading to altered sugar levels and can~     release molecules that act to reduce appetite.~      In this study we aim to find out how bariatric surgery changes the gut bacteria and how this~     leads to weight loss and improvement of diabetes. With this understanding we hope to~     discover potential targets for future treatments, such as identifying beneficial bacteria~     that could be supplemented with probiotics in patients.~      Additionally, although highly successful, up to 30% of obese patients do not undergo~     improvement of their diabetes after bariatric surgery. We aim to identify molecules within~     the patient's blood or urine that are able to predict the likely chance a patient will~     undergo improvement in their diabetes after bariatric surgery to help clinicians select~     patients most likely to benefit.~   "
48591|NCT02421042|"~     This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in~     subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh~     system, who will be matched with normal healthy subjects as controls.~   "
48592|NCT02421029|"~     The researchers propose to investigate the prevalence of gadolinium in the urine of patients~     with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge.~     Moreover, will investigate if there is any correlation of gadolinium urine levels with~     levels of endogenous (e.g zinc) and xenobiotic metals.~   "
48593|NCT02421016|"~     The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in~     patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES~     is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic~     efficacy as assessed by angiography at 6-8 months.~   "
48594|NCT02421003|"~     The recovered blood into the surgical site at the border of the fields, is very rich in red~     blood cells, due to the adjacency of the bone marrow and the sternum.~      The blood recovered from the surgical site at the border of the fields, is richer in red~     blood cells than the bloodstream of the patient.~      The recovered blood into the surgical site at the border of the fields, is not contaminated~     and bacteriological cultures are negative.~      Consequences: The recovered blood in the surgical site at the edge of fields, can be~     recovered in the Saver® Cell for reprocessing and re-injected into the patient.~      There isn't in our knowledge of published clinical data on the volume and composition of the~     recovered blood in the surgical site after cardiac surgery.~      The analysis of the available literature does not allow to estimate the expected outcomes~     us. Therefore, this study will be exploratory in nature and will aim to estimate the volume~     and the content of red blood cells from blood recovered, and generate clinical data to be~     used in subsequent confirmatory tests.~   "
48595|NCT02420990|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) exists in 20-50% of the 3 million~     adolescents annually enrolled in outpatient mental health and substance use treatment.~     Adolescents with ADHD present deficits in attention, self-regulation, and social competence~     that significantly impede achievement of developmental and educational milestones. Currently~     there are only two evidence-based treatment options for this age group: academic training~     and stimulant medications. Both options remain vastly underutilized. Academic training is~     not available in most school settings and rarely implemented in clinical care. Similarly,~     ADHD medications are rarely utilized with adolescents in primary or specialty care for a~     host of reasons related to stigma, misinformation about effects and side effects, and~     adolescent autonomy issues. Moreover, the widespread fragmentation of pharmacological versus~     behavioral services prevents families from making informed treatment selections.~      The primary objective of this randomized parametric trial is to compare the effectiveness of~     behavioral only versus integrated (behavioral plus medication decision-making) interventions~     for adolescents with ADHD in outpatient behavioral services. The behavioral intervention,~     Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA), contains three~     components: ADHD psychoeducation, family-based motivational interventions, and academic~     training. The medication decision-making intervention, Medication Integration Protocol~     (MIP), contain three components: psychoeducation about ADHD medication, family~     decision-making, and medication management. The study will compare the effects of two~     legitimate treatment options for adolescents with ADHD on service utilization, behavioral~     symptoms, and quality of life. It will generate new evidence on patient-centered treatment~     selection that aligns with family-specific principles and treatment goals.~      This parametric comparative trial will randomly assign 140 inner-city adolescents with ADHD~     to (1) CASH-AA Only or (2) CASH-AA + MIP. Treatment will occur in community behavioral~     health clinics. All participants will receive behavioral interventions (CASH-AA): family~     psychoeducation in ADHD symptoms, executive functioning, and developmental impacts;~     family-based motivation and ADHD accommodation interventions; and academic training focused~     on home environment support and organizational skills. Half of the participants will also~     receive medication decision-making interventions (MIP): ADHD medication psychoeducation,~     family decision-making interventions, and (for those who elect to start medication)~     coordinated medication management. Half of the sample will have comorbid substance use~     problems. Treatment will occur in three community clinics; therapists will be randomly~     assigned to study condition. Caregivers and adolescents will complete assessments at~     baseline, 3, 6, and 12-month follow-up. Multilevel modeling will compare the effectiveness~     of each condition on key patient and service use outcomes. Patient-centered analyses will~     explore differential treatment effects based on (a) Medication decision (yes/no); (b)~     Substance use comorbidity (yes/no); (c) Race/Ethnicity (Hispanic, African American).~      Quantitative outcome analyses will test for service use effects, symptom reduction, and~     quality of life improvements that are primary reasons for seeking clinical services.~     Qualitative interviews will document family-specific rationale for decisions about~     medication, compliance with behavioral and medication interventions, and suggestions for~     improving services and service integration. Note that families assigned to CASH-AA Only will~     retain the option of pursuing ADHD medication through treatment-as-usual procedures at their~     respective clinic. Similarly, families assigned to CASH-AA + MIP will not be required to~     start ADHD medication. Instead, they will receive informed-choice interventions and can~     choose when and if to start medication; the study will assess the impact of these decisions~     on clinical outcomes.~      If proven efficacious, the CASH-AA and MIP protocols could be rapidly disseminated~     individually or as an integrated protocol into routine behavioral healthcare settings. The~     protocols can also be readily combined with other behavioral treatments to form a~     multicomponent treatment package for adolescents with co-occurring behavior problems. In~     addition, the family-based, patient-centered CASH-AA and MIP protocols could be delivered in~     conjunction with other family-based treatments or with individual approaches that flexibly~     include caregivers in multiple treatment sessions. This makes CASH-AA and MIP highly~     efficient clinical resources for addressing ADHD-related problems in any outpatient setting~     that serves adolescents and their families.~   "
48598|NCT02420951|"~     The purpose of this study is to determine if an additional injection of local anesthetic~     immediately prior to removal of the local anesthetic infiltration catheter on postoperative~     day one is effective in increasing pain reduction, patient satisfaction or outcome measures~     following total knee replacement (TKR). It is hypothesized that an additional injection of~     30ml of .5% bupivacaine solution immediately before infiltration catheter removal will~     provide pain reduction, patient satisfaction and outcome measures equal or superior to~     catheter removal with no additional injection.~      Patients who are undergoing unilateral total knee replacement (TKR) and choose to~     participate will be randomly assigned to a treatment group.Patients in group one (treatment~     group) will receive a 30ml dose of .5% bupivacaine solution injected into the local~     anesthetic infiltration catheter immediately prior to its removal on postoperative day one.~     Patients in group two (control group) will receive no additional medication during local~     anesthetic infiltration catheter removal.~   "
48599|NCT02420938|"~     The goal of this clinical research study is to learn if urelumab given in combination with~     rituximab can help to control CLL or SLL. The safety of the drug combination will also be~     studied.~   "
48600|NCT02420925|"~     The investigators hypothesize that in patients with gastroparesis, gastric emptying will~     improve with celiac plexus block. By improving gastric emptying, symptoms related to~     gastroparesis including nausea, vomiting, bloating, abdominal pain, and weight loss, will~     also improve.~      In order to study this hypothesis, the investigators will enroll patients with gastroparesis~     who are non-responsive to the current treatments available. Patients will fill out a~     questionnaire to assess the severity of their symptoms then undergo Ansar testing (a~     non-invasive test) to measure their autonomic function respectively. Then, patients will~     undergo a celiac plexus block which is performed via an upper endoscopy. One week after the~     procedure, patients will be asked to undergo a gastric emptying study as well as repeat the~     Ansar testing to evaluate for any improvement in the gastric emptying and autonomic function~     respectively. Patient will be asked to repeat the questionnaire, one, two, three, and eight~     weeks after their procedure.~   "
48601|NCT02420912|"~     The goal of this clinical research study is to learn if nivolumab in combination with~     ibrutinib can help control CLL, NHL, or SLL. The safety of this drug combination will also~     be studied.~   "
48602|NCT02420899|"~     The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks~     can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute~     Coronary Syndrome (ACS) patients.~   "
48603|NCT02420886|"~     Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF~     5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on~     embryogenesis and implantation outcomes.~   "
48604|NCT02420873|"~     The goal of this clinical research study is to learn if lorvotuzumab mertansine can help to~     control blood cancers that have the CD56 tumor marker. The safety of this drug will also be~     studied.~   "
48605|NCT02420860|"~     The goal of this clinical research study is to learn if the combination of elotuzumab and~     revlimid (also called lenalidomide) can help to prevent MM from coming back after patients~     have had an autologous stem cell transplant. The safety of this drug combination will also~     be studied.~   "
48606|NCT02420847|"~     This clinical research study is made up of 2 phases.~      The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination~     of ixazomib, gemcitabine, and doxorubicin that can be given to patients with urothelial~     cancer.~      The goal of Phase 2 of this study is to learn if the combination of ixazomib, gemcitabine,~     and doxorubicin can help to control urothelial cancer.~      The safety of the drug combinations will be studied in both phases.~   "
48607|NCT02420834|"~     Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear~     quality and insufficient quantity. Treatments are traditionally in the form of artificial~     tears applied to the ocular surface. However, there is little evidence in the scientific~     literature that demonstrates their efficacy relative compared to each other, nor how to~     decide which one might be most effective for an individual patient. Therefore the~     investigators aim to examine the efficacy of different classes of artificial tears (those~     designed to increase viscosity, reduce evaporation or to mimic the component balance of the~     natural tears). In addition, the investigators also aim to determine how the treatment~     preferred by an individual could potentially have been predicted from their baseline~     condition.~   "
48608|NCT02420821|"~     This randomized, open-label study is designed to evaluate the efficacy and safety of~     atezolizumab (anti-programmed death ligand 1 [PD-L1] antibody) plus bevacizumab versus~     sunitinib in participants with inoperable, locally advanced, or metastatic renal cell~     carcinoma (RCC) who have not received prior systemic active or experimental therapy, either~     in the adjuvant or metastatic setting.~   "
48609|NCT02420808|"~     A nationwide registry of patients with acute coronary disease to evaluate epidemiological~     patient characteristics, medical management, implementation of invasive strategy, patient~     outcome and impact on quality of life in Greece.~   "
48610|NCT02420795|"~     This clinical research study will be done in two parts.~      The goal of the first part is to find the highest tolerable dose of ONC201 that can be given~     to patients with relapsed or refractory MCL, DLBCL, and TLCL. Groups of subjects will~     receive increasing doses of ONC201 by mouth on day 1 of each 21 days cycle or on Day 1 of~     every week until there are side effects that are not tolerated or a maximum of 625 mg has~     been found to be tolerable.~      As a result of new information, it has been decided that subjects in Arm A will continue~     receiving their dosing every 3 weeks. All other subjects will be dosed weekly. The dose you~     receive may be too low to have an effect or so high it causes bad side effects. In the~     second part of this study the highest dose of NC201 will be given to learn if ONC201 can~     help to control the disease. Please note that this is the first time ONC201 will be given to~     human subjects.~   "
48612|NCT02420769|"~     The purpose of this study is to determine whether assessing color doppler of corpus luteum~     and uterine artery is useful in predicting patients who will complete pregnancy. The~     investigators will add to this the usefulness of serum progesterone and CA125 in prediction.~   "
49325|NCT02411487|"~     To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland~     dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular~     surface parameters after cataract surgery according to the preoperative MGD grade.~   "
48613|NCT02420756|"~     The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will establish an~     open-label, longitudinal cohort study to assess the impact of amyloid PET on patient~     outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid~     Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries~     who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our~     hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the~     underlying cause of cognitive impairment, that this will translate into earlier counseling~     and interventions in these domains, and that these interventions will lead to improved~     outcomes.~   "
48614|NCT02420743|"~     Pregnant women with iron deficiency anemia during third trimester will be assessed for serum~     ferritin and peak systolic value for fetal middle cerebral artery to find out their~     correlation with preterm delivery.~   "
48615|NCT02420730|"~     This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3~     different concentrations of AGN-232411 topical ophthalmic solution in healthy participants~     and participants with dry eye.~   "
48616|NCT02420717|"~     The goal of this clinical research study is to learn if ruxolitinib or dasatinib in~     combination with chemotherapy can help to control Ph-like ALL. The safety of these drug~     combinations will also be studied.~   "
48617|NCT02420704|"~     Although many studies have evaluated the relationship between endometrial thickness and IVF~     outcome, the results are still controversial. We notice that, during our daily work, for~     patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a~     huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome~     seems to have little association with endometrial thickness. Thus, the aim of this~     prospective observational study is to explore the relationship between endometrial thickness~     and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers,~     respectively.~   "
48618|NCT02420691|"~     The goal of this clinical research study is to learn if LEE011 can help to control advanced~     neuroendocrine tumors of the foregut. The safety of this drug will also be studied.~   "
48619|NCT02420678|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause~     of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC,~     the prognosis of HCC is still poor even after curative treatment.~      Performance status has shown to be associated with long-term survival and prognosis in~     patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver~     Cancer (BCLC) staging system. Recently, the researches on health-related quality of life~     (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL~     of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European~     Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire~     (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were~     developed.~      The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary~     cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed~     to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National~     Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18)~     is a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However,~     there is no consensus whether it would be appropriate to adopt HRQL as a prognostic variable~     in HCC staging system. Moreover, there is limited information available about the impact of~     patients' HRQL on long-term outcome in patients with HCC.~      Thus, in this study, the researchers will investigate whether HRQL can be an important~     factor in HCC staging system by testing the reliability and clinical validity of FACT-Hep,~     EORTC QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL~     with treatment efficacy, recurrence and survival outcome. Lastly, the investigators will~     suggest the suitable questionnaire module for patients with HCC.~   "
48620|NCT02420665|"~     The goal of this clinical research study is to compare a type of imaging called~     high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the~     standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy~     procedure. Researchers also want to learn if HRME images can show the difference between~     cancerous tissue and normal cervical tissue.~   "
48621|NCT02420652|"~     This randomized phase II trial studies how well metformin hydrochloride and aspirin work in~     treating patients with hormone-dependent prostate cancer that has progressed after surgery~     or radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether giving~     metformin hydrochloride and aspirin together can slow the growth of prostate cancer.~   "
48622|NCT02420639|"~     The aim of this prospective, interventional study is to assess the feasibility and safety of~     the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the~     treating physician is treating with targeted temperature management. Comparison of outcomes~     will be made to historical controls. The primary outcome is the feasibility of inducing,~     maintaining, and rewarming patients from targeted temperature management using the~     Esophageal Cooling Device (cooling rate, rewarming rate, and the percent of time within goal~     temperature during the goal-temperature maintenance period). Evaluation of adverse events~     (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction,~     dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal~     injury, and esophagitis) will be closely monitored during the whole period of targeted~     temperature management (secondary endpoint).~   "
48623|NCT02420626|"~     The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano~     Corporation, to evaluate the short and long term performance and clinical outcomes of the~     Crux Vena Cava Filter System.~   "
48624|NCT02420613|"~     The goal of this clinical research study is to learn the highest tolerable dose of~     temsirolimus that can be combined with a stable dose of vorinostat and/or radiation therapy~     and given to patients with DIPG. The safety of this treatment combination will also be~     studied.~   "
48645|NCT02420340|"~     This pilot study will collect information about the the potential to use an evidence-based~     skills training program designed for older people with serious mental illness (SMI), the~     Helping Older People Experience Success (HOPES) program, to help nursing home residents with~     SMI gain the skills needed to successfully live in the community.~   "
48646|NCT02420327|"~     The aim of this study is to test whether the attention-enhancing effects of low-dose~     nicotine can be enhanced by the drug galantamine, FDA-approved for the treatment of~     Alzheimer's disease. This proof-of-principle study is performed in healthy non-smokers and~     involves two single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to~     galantamine (4 mg). The dose of galantamine is substantially lower than the clinical dose~     range of 16-24 mg/day. The hypothesis is that performance-enhancing effects of nicotine are~     greater in the presence of this low dose of galantamine.~   "
48625|NCT02420600|"~     Head and neck squamous cell carcinomas (HNSCCs) are mainly caused by tobacco, alcohol~     consumption and betel nut chewing and the sixth most common cancer in the world. Despite~     significant advances in the treatment modalities involving surgery, radiotherapy, and~     concomitant chemoradiotherapy, the 5-year survival rate remained below 50% for the past 30~     years.~      The worse prognosis of these cancers must certainly be linked to the fact that HNSCCs~     strongly influence the host immune system. During this process, mesenchymal tumor-like cells~     are highly mobile and enter quickly adjacent structure (intravasation), from where they~     travel through lymphatic and blood vessels as circulating tumor cells (CTC), which are~     single cells with malignant potential detected in the peripheral bloodstream and essential~     for establishing metastasis.~      Programmed death 1 (PD-1) and its ligand (PD-L1) play pivotal roles in regulating host~     immune responses. Substantial evidence has demonstrated that PD-L1 can deliver an inhibitory~     signal to PD-1 expressing T cells, leading to suppression of the immune response by inducing~     apoptosis, energy, unresponsiveness and functional exhaustion of T cells. However, the~     inhibitory effects of this pathway on the function of cytotoxic T lymphocytes, the main~     effector cells in HNSCC patients, are not well defined.~      In this study aims to solve two main problems: one is to improve and try to optimize current~     protocols of CTC isolations based on the investigator previous work, which is one of most~     challenging problems in CTC field to date; the other is to understand the status of immune~     system in HNSCC patients, especially focusing on PD-1-PD-L1 pathway and its expressions.~     After series basic experiments of immune cell analysis and conditional adjustment of CTC~     isolation protocols, the investigateor are willing to isolate CTCs and immune cells at a~     single blood drawing at the same time. A prospective trial will be conducted to elucidate~     the roles of PD-1 expression lymphocytes and CTC numbers on the clinical outcomes of HNSCC~     patients.~   "
48626|NCT02420587|"~     The goal of this clinical research study is learn how AMG208 may help to control prostate~     cancer that has spread to the bone. The safety of the drug will also be studied.~   "
48627|NCT02420574|"~     Infections with soil-transmitted helminthes (STH) occur throughout the developing world and~     remain a major public health problem in the poorest communities. Preventive chemotherapy~     (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg -~     the drugs of choice for STH - are administered at the population level, is the main strategy~     for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline~     (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In~     addition to this, there are a wide variety of ALB and MEB tablets available on the local~     market. Although little is known about the quality of anthelmintics sold for human use,~     several publications have reported variability in the quality of generic anthelmintics used~     in veterinary medicine. The main objective of the present study is to compare the efficacy~     of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical)~     and BENDEX (India, Cipla)~   "
48628|NCT02420561|"~     The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug~     use and depression symptoms, improve functional status and promote appropriate health~     services utilization, in a sample of 300 adults seeking treatment for depression who also~     report hazardous drinking or drug use with depression.~   "
48629|NCT02420548|"~     The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the~     factors that contribute to the behaviors and health of teen girls, such as girl's~     friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about~     how to make healthy choices. This study will inform us on ways to help teen girls engage in~     safe and healthy relationships and adjustment.~   "
48630|NCT02420535|"~     Behavioral symptoms that commonly occur with dementia are associated with increased health~     care utilization and can lead to challenges for the person living with dementia and their~     caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify~     what triggers them, and to learn how to use proven, practical medication-free strategies to~     prevent and manage the behaviors. The purpose of this study is to develop and test the~     WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps~     them to assess, manage and track behavioral symptoms and their contributing factors (e.g.,~     pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free~     behavior management. This study is a collaboration between researchers at the University of~     Michigan and Johns Hopkins University.~   "
48631|NCT02420522|"~     This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation~     (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The~     main objective of this study is to investigate the ability of rTMS to produce cognitive~     improvement in individuals with MCI. A secondary objective is to determine whether~     individuals with MCI following mild brain trauma respond differently to rTMS treatment~     compared to individuals with non-trauma related MCI.~      All participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and~     psychological assessments will be administered before and after each week of rTMS therapy,~     for both active and sham conditions. Cognitive testing will include verbal, semantic, logic,~     visual, conceptual, and memory tasks.~   "
48632|NCT02420509|"~     The purpose of this study is to find out if postoperative chemotherapy in patients with~     high-grade appendix cancer after surgery improves outcomes.~      The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with~     bevacizumab. These drugs are approved for use in people with colon cancer, and they are used~     at UCSD for some patients with appendix cancer.~      The purpose of this study is to explore the safety and efficacy of the postoperative~     chemotherapy treatment on cancer.~   "
48633|NCT02420496|"~     To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution~     and other markers of parenteral nutrition-associated liver disease.~   "
48647|NCT02420314|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care~     treatment of non-small cell lung cancer (NSCLC) in adults. All subjects will receive~     high-dose ascorbate in addition to the standard treatment.~   "
48648|NCT02420301|"~     Objective: To study the effects of self-administered exercises based on tuina techniques on~     the pain intensity caused by playing related musculoskeletal disorders (PRMD) of~     professional orchestra musicians, using numeric visual scale (NVS).~      Method: The investigators performed a prospective, controlled, single-blinded, randomized~     study with musicians suffering from PRMD. n= 69 musicians were randomly distributed into the~     experimental and into the control group. After an individual diagnostic assessment, specific~     tuina self-administered exercises were developed and taught to the participants. Musicians~     were instructed (educated) to repeat the exercises every day during 3 weeks. Pain intensity~     was measured by NVS before the intervention and after the 1st, 3rd, 5th, 10th, 15th and 20th~     days of self-exercising. The procedure was the same for the control group, however the Tuina~     exercises were executed in non-acupuncture points~   "
48634|NCT02420483|"~     The authors to measure passive tidal volumes generated during external chest compressions in~     order to determine whether chest compressions alone without any mechanical ventilatory~     support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will~     study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II,~     candidates for surgical operation, who will receive general anesthesia. Patients who will be~     operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular~     acute or chronic diseases, who had history of pneumothorax, of thromboembolism,~     osteoporosis, menopause, history of current rib or sternal or clavicle fractures, will be~     excluded. All eligible patients will enter the study and will receive general anesthesia and~     intubation according to treating doctors' decision.~      Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A~     pneumotachograph will be then connected to the ventilatory circuit so that respiratory~     efforts (volume, airway pressure and flow) can be continuously monitored at real time.~      An esophageal catheter will be then inserted to monitor esophageal pressures and to provide~     data for lung mechanics calculation. Following the above procedures and before any surgical~     procedure, chest compressions will be performed to the patient by a senior anesthesiologist~     according to ERC guidelines of 2010 for 30 seconds.~      Following chest compressions, patients will be evaluated for possible complications and~     after the establishment of stable conditions surgical procedures will follow. After the end~     of the surgical operation clinical and chest ultrasound evaluation will be performed.~      Written inform consent will be obtained by all patients before procedures.~   "
48635|NCT02420470|"~     Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function~     impairment, especially the mild cognitive impairment that increased the risk of progression~     to dementia.The primary objectives are defined according to a hierarchical design: i) to~     tailor and apply multi-parametric, functional MRI techniques to identify cerebral~     abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes~     mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive~     decrements;iii) to follow up with the putative prediabetic condition patients to verify~     whether they can transform into diabetes.~   "
48636|NCT02420457|"~     The investigators are assessing the validity of fitness devices as surrogate measures of~     chronic pain survey outcomes.~   "
48637|NCT02420444|"~     70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized~     to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose~     (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231,~     and followed through Study Day 259.~   "
48638|NCT02420431|"~     Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and~     quality of life, and reduce the risk of further cardiac events. Depression and anxiety~     (distress) are common among CR patients: 37% of patents have significant anxiety and/or~     depressive symptoms. Distressed patients are at greater risk of death, further cardiac~     events and poorer quality of life than those without distress and they use more healthcare.~     Available drug and psychological treatments have only small effects on distress and quality~     of life, and no effects on physical health. Therefore, it is essential that more effective~     treatments for depression and anxiety are integrated into CR services. Extensive evidence~     shows that a particular style of thinking dominated by rumination (dwelling on the past) and~     worry maintains emotional distress. A psychological intervention (metacognitive therapy)~     that reduces this style of thinking alleviates depression and anxiety in mental health~     settings. The investigators aim to conduct a pilot trial of the group intervention and in~     work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding~     the group intervention to standard CR is more effective at alleviating anxiety and~     depression than standard CR alone.~   "
48639|NCT02420418|"~     Background: . Bipolar disorders and tobacco use disorder are top of the causes of disability~     and mortality worldwide Objective: The aim of this study was to evaluate N-acetyl-cysteine~     (NAC) as an adjunctive treatment in patients with bipolar .disorders and tobacco use~     disorder (TUD)~      , to determine whether NAC reduces alterations in biomarkers of inflammatory and oxidative~     stress Methods: This study will be conducted as a double-blind, randomized, placebo~     controlles add NAC or placebo for .bipolar disorders and tobacco use disorder at Londrina~     State University, Brazil.~   "
48640|NCT02420405|"~     The objective of the study was to compare the value of routine gene testing and~     next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by~     endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge~     of how many EBUS-TBNA samples were adequate for NGS.~   "
48641|NCT02420392|"~     To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic~     beta cell.~   "
48642|NCT02420379|"~     This is an open-label study to assess the safety, tolerability, efficacy and~     pharmacokinetics of eteplirsen in patients with early stage Duchenne muscular dystrophy~     (DMD) who are amenable to exon 51 skipping.~   "
48643|NCT02420366|"~     A multi-center, retrospective study of cases of serious bacterial infections including~     complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired~     Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or~     bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)~   "
48644|NCT02420353|"~     Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries~     that occur in physically active individuals. Despite advances in minimally invasive surgical~     reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength~     can persist even after patients return to full activity and can place them at considerable~     risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic~     interventions to prevent muscle atrophy is needed to advance the care of patients who suffer~     from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays~     an important role in promoting muscle growth and protecting muscle from atrophy. While GH~     therapy has shown promise in protecting immobilized muscle from various models of disuse~     atrophy, it remains unknown whether GH can help to restore strength and protect against the~     loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe~     return to play of patients that suffer ACL tears, and help to prevent the long-term OA and~     reduction in quality of life that occur after these traumatic knee injuries.~   "
48652|NCT02420249|"~     Objectives: (1) To investigate the effects of Qigong training on upper limb oedema,~     circulatory status, shoulder flexibility and muscular strength, body balance, and quality of~     life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the~     relationship between the impairment outcomes and QOL outcomes.~      Hypothesis: (1) The experimental participants will have less impairment and a better QOL~     after Qigong training compared with the no-training control group; and (2) the impairment~     parameters will be related to the QOL indexes in the Qigong participants.~      Design and subjects: This will be a prospective, randomised, single-blinded controlled~     trial. Approximately 60 breast cancer survivors will be randomly assigned to either the~     Qigong training group (n~30) or control group (n~30).~      Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal~     Qigong training for 3 months with two supervised 1-hour sessions per week.~      Main outcome measures: The primary outcome measures are upper limb circumference, arterial~     blood flow velocities and resistance index, shoulder joint passive range of motion, muscular~     strength (peak force) and body balance. The secondary outcome measure is quality of life as~     measured by the Functional Assessment of Cancer Therapy - Breast scale.~      Data analysis: Data will be analysed via repeated-measures analysis of variance followed by~     post-hoc tests (α = 0.05).~      Expected results: The investigators pilot studies produced encouraging results on the~     efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors.~     Therefore, the investigators expect that participants in the Qigong group will have fewer~     upper limb impairments and a better quality of life after Qigong training. If the results~     are positive, this Qigong training regime is readily transferrable to clinical practice, and~     could have positive socioeconomic effects such as reduced healthcare costs.~   "
48653|NCT02420236|"~     The purpose of this study is to investigate if high-intensity resistance training can induce~     additional beneficial effects, for patients with moderate to severe long term pain in the~     low back, when added to a multidisciplinary treatment program.~   "
48654|NCT02420223|"~     This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic~     antagonist propranolol is effective in decreasing gene expression of stress-mediated~     beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic~     stem cell transplant (HCT) for multiple myeloma.~   "
48655|NCT02420210|"~     This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and~     dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used~     in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab,~     may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab,~     and dexamethasone may kill more cancer cells.~   "
48656|NCT02420197|"~     The purpose of this study is to investigate if high-intensity resistance training can induce~     additional beneficial effects, for patients with moderate to severe long term pain in the~     neck, when added to a multidisciplinary treatment program.~   "
48657|NCT02420184|"~     This study is being conducted to determine whether treatment of obstructive sleep apnea~     (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the~     participants will receive continuous positive airway pressure (CPAP) treatment for their OSA~     in addition to their regular CKD treatment, while the other half will only receive their~     regular CKD treatment.~   "
48658|NCT02420171|"~     Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of~     In Vitro culture and detect the the effect upon embryo quality and implantation potential.~   "
48659|NCT02420158|"~     This pilot study plan to investigate the sympathovagal balance in women affected by~     Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous~     vagal nerve electrical stimulation on digestive physiology (intestinal transit time,~     intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of~     life.~      The safety of the electrical stimulation of the left vagal nerve will also be evaluated.~      Ten women, age between 18 and 60, will be included.~   "
48660|NCT02420145|"~     The aim of this randomized trial is to investigate the effects of a 12-week yoga~     intervention compared to no specific intervention on weight-related outcomes, well-being,~     and health behaviour in 60 females with abdominal obesity.~   "
48661|NCT02420132|"~     Study to Evaluate Home Vision Testing in Patients Receiving Ranibizumab~   "
48662|NCT02420119|"~     Intravenous iron therapy is common and effective, with few side effects. Two formulations~     are used, venofer or iron sucrose and ferrlecit, or ferric gluconate.~      The association between intravenous iron use and decrease in serum phosphorus and vitamin D~     levels, with increased fractional excretion of phosphorus, has been observed with older iron~     preparations, such as saccharated ferric oxide. However, hypophosphatemia and osteomalacia~     have been reported with iron carboxymaltose, a newer iron formulation. There is no~     information in the literature about phosphorus and vitamin D levels after treatment with~     venofer or ferrlecit. We intend to check phosphorus and vitamin D serum levels in our~     patients prior to and after treatment with these iron formulations.~   "
48663|NCT02420106|"~     The purpose of the proposed research is to determine if Osteopathic manipulative medicine~     (OMM) used alone or in combination with the standard treatment of botulinum toxin~     intramuscular injections improves motor function and quality of life amongst people with~     cervical (neck) dystonia.~   "
48664|NCT02420093|"~     The aim of this study is to examine the clinical effects of supporting the human pelvis in a~     neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral~     sitting posture will be supported by a portable and adjustable pelvic support device or~     pelvic support assembly per US Patent number US 8,857,906 B2 that is used in the seat of~     the user's desk chair.~   "
48665|NCT02420080|"~     The objective is data collection to determine background rates of adenovirus (AdV)~     progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.~   "
48680|NCT02419885|"~     Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of~     the hands and have an aesthetic function. Fingertip injuries are defined as injuries~     occurring distal to the insertion of the flexor and extensor tendons. These injuries are one~     of the most common trauma injuries presented in acute care settings, accounting for~     approximately 4.8 million emergency department visits per year in the United States.(1)~     Fingertip amputations may not constitute the majority among these fingertip injuries but can~     have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on~     preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail~     structure, achieving a well-contoured and painless fingertip, and restoring durable and~     sensate skin.~      There are so many factor that influence the result of composite graft in distal finger tip~     amputation. Investigators will collected the data including the size of amputee , shape,~     level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation~     procedures.~   "
48666|NCT02420067|"~     The purpose of the study is to investigate how best to screen for Endolymphatic sac tumors~     (ELSTs) in von Hippel-Lindau (vHL) patients in order to diagnose the ELSTs while they are~     still small so that hearing loss can be prevented.~      Up to 16% of vHL patients are known to develop endolymphatic sac tumors in the inner ear~     that can cause permanent hearing loss. However, the ELSTs are often not found before hearing~     loss has already occurred. The challenge for doctors is to diagnose the ELSTs at early~     stages before they cause often irreversible deafness. In order to find ELSTs before they~     cause hearing loss, it is important to screen for the tumors prophylactically, that is~     screen all vHL patients regardless of whether or not they have symptoms.~      Who can join? Persons diagnosed with vHL who are at least 15 years old. The investigators~     include patients WITH OR WITHOUT a diagnosed ELST.~      What does it involve? You need to have a hearing test and an MRI of the brain, where the~     inner ear can be seen, most vHL patients have already had this done as part of their~     surveillance program.~      Participants will be asked to participate in follow up examinations (hearing test and/or MRI~     of the brain) after 2, 5, and 10 years.~      How can I join? A doctor has to be responsible for the study in each country where vHL~     patients participates.~      Ask the doctor who manages your vHL examinations to contact us or contact us yourself and~     the investigators will help you find a doctor in your country who will participate in the~     study.~   "
48667|NCT02420054|"~     The purpose of the study is to determine the effect of intermittent fasting on insulin~     sensitivity in skeletal muscle and fat distribution.~   "
48668|NCT02420041|"~     The purpose of this research project is to compare two different techniques for performing~     an injection of the sacroiliac joint. Although both techniques are safe and accurate, the~     goal of the study is to determine if one technique is better than the other with respect to~     improvement in a patient's pain, function, and his or her satisfaction. Additionally, the~     investigators want to determine if one technique is quicker and more efficient than the~     other.~   "
48669|NCT02420028|"~     A prospective, single-center, open-label, randomized controlled trial to assess the safety~     and efficacy of the OptiVein IV Catheter in an oncology population. The study hypothesis is~     that OptiVein IV Catheter use will be superior to the control in successful venous access~     after first attempt.~   "
48670|NCT02420015|"~     This study is designed to evaluate if a treatment the investigators call iCOMMIT is~     effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation~     treatment that combines mobile technology with behavioral strategies, counseling, and~     medications.~   "
48671|NCT02420002|"~     This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain~     control via MEOPA (equimolar mixture of nitrous oxide and oxygen) in one arm versus~     Hypnosis + MEOPA if needed in the second arm.~      The primary objective is to compare the two study arms in terms of efficacity for pain~     control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool)~     behavioural scale.~   "
48672|NCT02419989|"~     No nontuberculosis mycobacteria (NTM) treatment protocol has been validated in the setting~     of cystic fibrosis (CF). This trial tests the feasibility of a standardized treatment~     algorithm for confirmed disease by either M. avium complex or the M. abscessus complex that~     is also based on forthcoming guidelines from the CF Foundation (CFF) and the European CF~     Society (ECFS). The primary endpoint is 12 months of negative NTM cultures following~     completion of therapy.~      The investigators' near-term goal is to validate both protocols by extending the trial to 5~     additional CF Centers. The long-term goal is to make the validated protocols available to~     the entire CFF Care Center Network.~   "
48673|NCT02419976|"~     The investigators will study a noninvasive no risk process by which the investigators can~     quickly screen and assess for fasting and non-fasting states in individuals scheduled for~     routine endoscopy.~   "
48674|NCT02419963|"~     Microbiota from fecal samples from IBS-D patients, in combination with vitamin D~     supplementation added to our 3-D immunocompetent intestinal models will establish a high~     fidelity disease model to achieve our long-term goal to understand the relationship between~     gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could~     ultimately be used as a testing platform for treatment and prevention.~   "
48675|NCT02419950|"~     Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim~     was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF)~     of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of~     patients were studied for pain interfering with sexual activety. The hyopthesis is that~     fixation causes pain.~   "
48676|NCT02419937|"~     Introduction: Interleukin 6 (IL-6) is a cytokine that has a pro-inflammatory effect on the~     immune system. In acute MI IL-6 levels rapidly increase in response to ischemia and~     inflammation. Tocilizumab is a humanized monoclonal antibody against the interleukin-6~     receptor (IL-6R). The use of tocilizumab within the first 24 hours of admission for acute MI~     could reduce 30 day mortality.~      Methods: This randomized, placebo controlled trial will assign subjects within 24 hours of~     admission to treatment with either 162 mg of tocilizumab subcutaneously once or placebo in~     addition to usual pharmacologic and interventional standard of care for acute MI (ST segment~     elevation MI or non-ST segment elevation MI).~      Outcomes: The primary outcome is difference in 30 day (plus/minus 5 days) occurrence of~     major adverse cardiac events (as defined later in this protocol) between placebo and~     Tocilizumab treated groups. Secondary outcomes to be assessed include length of~     hospitalization, readmission rates by day 30, CRP levels at 0 hours, 24 hours, 48 hours, and~     30 days following treatment, and safety of Tocilizumab with focus on rates of known side~     effects.~   "
48677|NCT02419924|"~     Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory~     constipation due to pelvic floor laxity and excessive perineal descent by means of a~     modified toilet seat, known as the Bottom's Up.~   "
48678|NCT02419911|"~     This is a post market, prospective, comparison study of the use of the FloShield Air System~     versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.~   "
48681|NCT02419872|"~     The study is to evaluate the percentage of patients with asthma or COPD achieving disease~     control~   "
48682|NCT02419859|"~     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported~     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2~     diabetes mellitus (T2DM).~   "
48683|NCT02419846|"~     This clinical trial studies an informed decision making intervention of screening for~     prostate cancer in predominantly African American participants. It also evaluates~     participants' knowledge about prostate cancer screening and to improve understanding. Using~     decision aids such as culturally sensitive written material, verbal information, and videos~     to educate patients about screening may increase patient participation and knowledge. This~     may increase confidence in participants' decisions. Raising awareness about prostate cancer~     in the communities may increase the participants' willingness to be screened for prostate~     cancer once they have learned about it.~   "
48684|NCT02419833|"~     In patients with acute myocardial infarction without ST-segment elevation on ECG~     (non-STEMI), previous studies have indicated that routine invasive treatment confers more~     benefit as compared to selective invasive approach. The benefits of routine invasive~     coronary intervention have been the most evident in patients with higher baseline risk~     profile. However, the question of optimal timing of routine invasive intervention remains~     unsolved.~      Immediate invasive intervention early after admission for non-STEMI may limit myocardial~     necrosis by securing the patency of the culprit coronary artery. Nevertheless, several~     previous studies reported higher levels of biomarkers of myocardial injury in patients~     undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients~     may thus amount to whether the risk of intervening on an unstable plaque is greater than the~     risk of new ischemic events while waiting for the invasive procedure.~      The purpose of the present study is to compare effects of immediate coronary intervention,~     within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission,~     in patients witn non-STEMI.~   "
48685|NCT02419820|"~     Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral~     Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791~     (Temanogrel) Co-administered with Aspirin and Clopidogrel.~   "
48686|NCT02419807|"~     This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical~     stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or~     mastectomy and planned axillary sentinel node biopsy procedure. Patients will undergo~     lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine~     clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to~     planned next morning surgery or on the morning of surgery. Patients will undergo~     lymphoscintigraphy in accordance with standard clinical practice.~      Immediately prior to operation, after the induction of anesthesia in the operating room, up~     to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the~     tumor or into the subareolar region after disinfection of the breast skin. ICG movement will~     be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence~     will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made~     evident by the fluorescent dye, will be monitored in real time on a monitor. The~     fluorescence will be followed towards the armpit region (axilla) and time for the~     fluorescence to reach the axilla will be recorded. Following standard practice, an incision~     will be made in the armpit region. Fluorescent lymph nodes (ICG positive) will be localized~     and removed and analyzed by a pathologist. Node removal will continue until no residual~     fluorescence is visible in the axilla. Removed nodes will be tested for radioactivity using~     a standard gamma-detecting probe and the counts per minute will be recorded. Finally, the~     armpit region will be inspected with the gamma probe to determine if there are any residual~     radioactive nodes. Residual sentinel nodes (the first node to receive lymph from a tumor)~     will be removed. For the purposes of this study, the sentinel status of a node will be~     defined as being flagged as sentinel by either one or both of the ICG or 99mTc methods. The~     goal of the project is to confirm that axillary lymphatic mapping with ICG leads to similar~     nodes being labeled as sentinel as lymphatic mapping with 99mTc-labeled radiotracer.~   "
48687|NCT02419794|"~     The aim of this study is to clarify treatment status and clinical results of acute cerebral~     ischemia after approval of clot retriever in Japan, and also to obtain a basis for~     comparative studies.~   "
48688|NCT02419781|"~     The aim of this study is to clarify the efficacy of the endovascular treatment for acute~     ischemic stroke patients with large vessel occlusion and are not respond to intravenous~     recombinant tissue plasminogen activator (rt-PA) therapy.~   "
48689|NCT02419768|"~     Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The~     parkinsonian gait is characterized by reducted stride length and gait speed, postural~     disorders (with a high risk of falling) and a modification of stride duration variability.~     This variability can be assessed by its magnitude (SD and CV) and its temporal organization~     (long-range autocorrelations). Healthy human gait presents with an interdependency between~     consecutive cycles that can span over hundreds of strides (long-range autocorrelations).~     Numerous observations plead for a relation between long-range autocorrelations and~     functional abilities of the system. Complementary to drugs, rehabilitation becomes an~     important way to treat PD.~      The aim of our study is to assess by a controlled, randomized, single blinded clinical~     study, the effect of physical exercise on stride duration variability, neurological~     impairments and walking abilities of parkinsonian patients.~      Physical exercise program will include 30 sessions spread over 15 weeks following the~     guidelines. Long-range correlations analysis, including the study of Hurst and α exponents,~     will be performed on a minimum of 512 consecutive cycles. Finally, the functional assessment~     of the parkinsonian patient will be done according to International Classification of~     Functioning Disability and Health (ICF).~   "
48690|NCT02419755|"~     This study will test the safety and effectiveness of adding bortezomib and vorinostat to~     other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs~     have been approved by the Food and Drug Administration (FDA) to treat other cancers in~     adults, but they have not yet been approved tor treatment younger patients with leukemia.~      PRIMARY OBJECTIVE~        -  To estimate the overall response rate of patients with MLL rearranged (MLLr)~          hematologic malignancies receiving bortezomib and vorinostat in combination with a~          chemotherapy backbone.~      SECONDARY OBJECTIVES~        -  Estimate event-free and overall-survival.~        -  Describe toxicities experienced by participants during treatment.~      OTHER PRESPECIFIED OBJECTIVES~        -  To identify all genomic lesions by comprehensive whole genome, exome and transcriptome~          sequencing on all patients.~        -  To compare minimal residual disease (MRD) results by three modalities: flow cytometry,~          polymerase chain reaction (PCR) and deep sequencing.~   "
48691|NCT02419742|"~     This is a prospective, phase IV, multi-center, single arm, open-label, interventional study~     in patients with Human Epidermal growth factor Receptor 2 (HER2)-positive node positive or~     High risk node negative breast cancer.~   "
48692|NCT02419729|"~     Forty-five women will be included in a double-blind randomized trial in order to compare~     fractional CO2 laser treatment, local estrogen therapy and the combination of both~     treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse~     effects CO2 laser treatment.~   "
48693|NCT02419716|"~     This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at~     3 years in average risk patients.~   "
48695|NCT02419690|"~     This study aims to use a text messaging intervention to prevent unintended teen pregnancy~     and transmission of sexually transmitted disease. The study will be informed by a formative~     qualitative phase (February 2014 - January 2015) which will include individual qualitative~     interviews and focus group with teens to elucidate and explore the barriers to effective~     contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback~     on the developed intervention. The second efficacy phase will randomize subjects to the~     texting intervention or to usual care.~   "
48696|NCT02419677|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     colorectal cancer liver metastases (CRCLM).~   "
48697|NCT02419664|"~     Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of~     pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of~     administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the~     detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer~     expression to somatostatin receptor (sst) occurrence Study design: Prospective~     non-randomised case-control study with open design with GA-PET before and after pituitary~     surgery in patients with pituitary tumours Study population: patients with acromegaly~     (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours~     (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45~     Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary~     tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or~     NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists.~      Exclusion criteria: Patient who may not attend to the protocol according to the~     investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours.~     Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF)~     production. Known or suspected allergy to the trial product or related products.~      Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid~     infusion (part of another study see this protocol)- Study variables: Tumour detection,~     Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in~     regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study~     termination 3 years later~   "
48698|NCT02419651|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in~     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg~     1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before~     the procedure and the third will receive a placebo. Pain will be assessed by a visual~     analogue scale~   "
48699|NCT02419638|"~     To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week~     (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or~     enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who~     are prescribed these medications and receive a 6 month MRI scan as standard of care.~   "
48700|NCT02419625|"~     Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately~     7.2kb in length. The HEV genome is capped at the 5' end followed by a small untranslated~     region of 27 nucleotides and polyadenalated at the 3' end preceded by another UTR of 65~     nucleotides . HEV has three open reading frames: ORF1, ORF2 and ORF3 that encode structural~     and non- structural proteins. ORF1 is the largest one, approximately 5,000 nt in length,~     located at the 5 ' end and encodes important proteins for the replication process~     (methyltransferase, papain-like cysteine protease, helicase, and RNA-dependent RNA~     polymerase). A noncoding, hypervariable region within ORF1 displays substantial genetic~     diversity; this region seems to modulate the efficiency of HEV replication. Notably, the~     differences in the genome size among different HEV strains are confined mainly to this~     region .ORF2 is located at the 3' end, encodes structural capsid proteins of 660 amino acids~     and contains three potential glycosylation sites. The ORF2 protein contains multiple~     immunogenic sites and neutralizing antibodies are directed against it al., .The essential~     region in the protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have~     recently been shown to be conformational .ORF3 is located between the other two reading~     frames and encodes a small phosphoprotein of 123 amino acids. Its exact function has not~     been yet determined, however, multiple functions have been proposed. It is thought to~     interact with cellular mitogen-activated protein kinase phosphatase and other extracellular~     kinases, promoting cell survival through activation of intracellular signaling pathways~     .Moreover, the binding of the ORF3 encoded protein to host-specific proteins seems to~     influence the pathogenesis of HEV infections .A schematic drawing of the HEV genome is~     described in Figure 1 .~   "
48701|NCT02419612|"~     This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,~     in addition to metformin, results in better glycemic control, as measured by HbA1c, over a~     treatment period of 52 weeks, compared to the addition of glimepiride to metformin in~     subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin~     Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in~     co-administration with dapagliflozin, added to current background therapy with metformin~     compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week~     52.~   "
48702|NCT02419599|"~     This study is a pilot trial investigating the effects of a high energy drink for children,~     in comparison to standard energy drink for children.~   "
48703|NCT02419586|"~     Gum chewing group will have less ileus and early resume of bowel motion than control group.~   "
48704|NCT02419573|"~     The primary objective of the trial is to determine if 72-hour survival after out-of-hospital~     cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial~     laryngeal tube (LT) airway management strategies.~   "
48705|NCT02419560|"~     The purpose of this study is to determine the optimal dosing scheme for the combination of~     ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma~     (MCL).~   "
48706|NCT02419547|"~     This research study is being done to see whether general anesthesia (GA) affects our ability~     to start ventricular tachycardia (VT) during an VT ablation procedure.~      Data collected during this research study will help electrophysiologists and~     anesthesiologists to make the best decisions about the best anesthetic conditions to use to~     perform VT ablations.~      This research study is a pilot study. Pilot studies are done on a small group of subjects~     to learn if a larger study would be useful.~   "
48707|NCT02419534|"~     To evaluate whether effectively treating anal fissure-associated constipation using oral PEG~     alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies~     have shown the topical agent are more effective in treating anal fissure when combined with~     less effective laxatives~   "
48710|NCT02419495|"~     Objectives:~      Primary Objective:~      To establish the safety and tolerability of Selinexor when given in combination with~     standard chemotherapy regimens.~      Secondary Objectives:~      To determine disease control and progression free survival of Selinexor administered with~     standard chemotherapy treatments.~      Exploratory Objectives:~      To determine the correlation of translational biomarkers To compare serial assessment of~     mutation status in biopsies obtained at baseline and progression after clinical response to~     combination therapy~   "
48711|NCT02419482|"~     The aim is to investigate whether 16 weeks of high intensity interval training, followed by~     36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic~     Ovary Syndrome (PCOS) compared with a non-exercising control group.~   "
48712|NCT02419469|"~     The goal of this clinical research study is to learn if a chemotherapy combination called~     augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab,~     can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety~     of these drug combinations will also be studied.~      Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG~     asparaginase, and methotrexate.~   "
48713|NCT02419456|"~     Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to~     prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs~     containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176)~     and MK-2048, in healthy, HIV-uninfected women.~   "
48714|NCT02419443|"~     A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain~     lasting longer than 3 months. Gabapentin is an anticonvulsant that is also of benefit in the~     treatment of neuropathic pain. We propose a randomized, double-blind, placebo controlled~     study of the effect of gabapentin on CGP after IHR. Their pain will be assessed with a~     visual analogue scale. For those reporting pain, the need for pain medication, or other~     treatment, and the effect of pain on their quality of life will be recorded.~   "
48715|NCT02419430|"~     The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT)~     intervention for Mayo Clinic employees in order to provide evidence for improved ability to~     cope with stress and decreased work-related burnout and stress-related symptoms as a result~     of MBRT training. In addition, the investigators aim to compare the effects of MBRT +~     smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback,~     or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of~     75 Mayo Clinic employees.~   "
48716|NCT02419417|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of BMS-986158 in subjects with select advanced solid tumors.~   "
48717|NCT02419404|"~     The investigators hypothesize that analysis of blood pressure will allow doctors to predict~     whether or not blood flow from the heart (cardiac output) increases after intravenous fluids~     are given.~   "
48718|NCT02419391|"~     A total of 63 subjects will be recruited into three groups (18 subjects per group will~     receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen~     suspension of MVA BN RSV.~      Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per~     0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.~   "
48719|NCT02419378|"~     Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada®~     is approved for the treatment of a particular form of multiple sclerosis (the so called~     relapsing remitting form). The excellent efficacy of the drug justifies its administration~     albeit a high risk of considerable side effects. In this context, so called secondary~     (occurring after the administration of Lemtrada®) autoimmune diseases are of particular~     importance. In these diseases the immune system acts against structures of the body itself;~     the reasons are still unknown. Autoimmune diseases may even occur several years after~     treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo~     intensive long term health monitoring.~      This study aims to elucidate which mechanisms cause to the positive and negative effects of~     Lemtrada®.~      The study includes patients only, who suffer from multiple sclerosis and are indicated to be~     treated with Lemtrada®. All patients receive the drug according to the official~     recommendations.~   "
48720|NCT02419365|"~     The purpose of the international prospective PCD Patient Registry is to systematically~     measure, survey and compare different aspects of PCD manifestation, course and treatment, to~     provide data for epidemiological research and to identify special patient groups suitable~     for multi-center trials.~   "
48721|NCT02419352|"~     Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after~     both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim~     of this study is to examine the possible effect of the novel reversal agent sugammadex~     versus neostigmine/ atropine combination on cognitive function of adult patients after~     elective surgery during the early post operative period as well as at discharge.~   "
48722|NCT02419339|"~     Prospective multicenter observational study of early infancy ureteral reimplantation for~     distal ureteral obstruction.~      The study is an observation study since the investigators will not assign specific~     interventions to the subjects of the study.~      The purpose of the study is to describe the surgical outcomes of early infancy ureteral~     reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no~     other urologic pathologic and a normal contralateral kidney who have been recommended a~     ureteral reimplant by their pediatric urologist are eligible for the study. Patients that~     consent for the study will be prospectively followed for 1 year to record the outcomes of~     the surgery.~   "
48723|NCT02419326|"~     The purpose of this study is to test the feasibility, acceptability, and preliminary~     efficacy of a novel couple-based intervention for binge-eating disorder (BED).~   "
48724|NCT02419313|"~     The scientific aim of this study is to investigate the efficacy and safety of~     incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson‟s disease. Our~     hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases~     the tremor amplitude and frequency leading to improvement of the patient‟s function.~   "
48725|NCT02419300|"~     Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of~     conception after second trimester miscarriage to select who will benefit from surgical~     evacuations or conservative management.~   "
48730|NCT02419235|"~     Refractory hypertension is defined as failure to reach goal blood pressure control in~     patients who are adherent to full doses of the appropriate drug regime. Hypertension results~     in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it~     the number one attributable risk for death throughout the world. Conventional treatment~     involves lifestyle modification and antihypertensive drug therapy; however blood pressure~     can remain uncontrolled despite these treatment options. Previous studies have demonstrated~     a reduction in blood pressure in adults with essential hypertension with the use of various~     homoeopathic complexes. There has been no research done to date on the effect of the~     homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum~     muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.~      The aim of the study is to investigate the effect of a homoeopathic complex Amylenum~     nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora~     6cH on blood pressure in adults with refractory hypertension, by means of blood pressure~     readings.~   "
48731|NCT02419222|"~     This research project is a study designed to address both motor and cognitive changes after~     stroke. Treatment for SN is elusive however there is support for prism adaptation treatment~     (PAT). Therapists need to know more about the effects of this treatment and if it is~     feasible in a group of stroke survivors with multiple lesions because these are the patients~     they are treating in the clinical setting. Also, it has not been investigated that using PAT~     to remediate SN will then as a result increase spontaneous UE movement of the weak limb.~   "
48732|NCT02419209|"~     Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in~     females. Menopause is defined as the physiologic cessation of menses brought on by a~     decrease in ovarian function and is established once menses have been absent for at least~     twelve months. Perimenopause refers to the period shortly before as well as the twelve~     months after the last menstrual period. The duration of perimenopause varies greatly and~     signs and symptoms usually begin appearing during a woman's forties. A longitudinal study~     conducted in Seattle showed that women experienced a significant reduction in sexual desire~     during the late perimenopausal and early postmenopausal stages, with the biggest decline in~     sexual desire occurring from three years prior to two years after the final menstrual~     period. Despite being a prevalent female complaint, currently no standard treatment for low~     sexual desire exists. Homeopathy may offer a safe and effective solution for this common~     problem, however limited research has been conducted to date.~      The aim of this study is to explore the effect of individualised homeopathic treatment on~     low sexual desire in perimenopausal females using detailed case studies, the desire and~     arousal subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the~     Female Sexual Distress Scale - Revised (FSDS-R).~   "
48733|NCT02419196|"~     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography~     and spirometry will be investigated in patients at risk for postoperative pulmonary~     complications. Those patients undergo abdominal and limb operations. In a pilot study arm~     electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib~     fractures.~   "
48734|NCT02419183|"~     The purpose of this study is to evaluate the psychometric properties of a Self-administered~     Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory~     Verbal Learning Test (RAVLT) in normal control (NC) participants and participants with Mild~     Cognitive Impairment (MCI) against a standard version of the RAVLT test, administered by an~     examiner under the same conditions.~   "
48735|NCT02419170|"~     The purpose of this research study is to study the safety and immune response of people who~     receive a personalized dendritic cell vaccine with the intention of stimulating the immune~     system to react to lung cancer cells.~   "
48736|NCT02419157|"~     The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical~     lesions (NCCLs) restored with two self-etching adhesive systems applied with or without~     selective enamel etching.~   "
48737|NCT02419144|"~     This study will test an intervention designed to change oral health norms and reduce~     disparities in oral health among vulnerable adults residing in publicly funded senior~     housing in Central Connecticut. The intervention model is based on Fishbein modified theory~     of reasoned action operationalized through Adapted Motivational Interviewing and Practice to~     Mastery. The intervention includes two components: 1) a face to face administration of the~     Adapted Motivational Interviewing and Practice to Mastery, a participatory counseling model,~     and 2) a targeted building level campaign consisting of three half-day oral health events~     with skills development through practice to mastery to parallel the individual intervention,~     all based on the study's conceptual model. The study uses a modified fractional factorial~     design to evaluate the face to face and campaign components separately and in different~     additive sequences. Six buildings will be paired in three dyads. The buildings in each dyad~     will be randomized to either having the Adapted Motivational Interviewing and Practice to~     Mastery intervention first followed by campaigns or to having the campaigns first followed~     by Adapted Motivational Interviewing and Practice to Mastery. Seventy-five residents will be~     recruited in each building for a total of 450 participants. There will be four assessments:~        1. T0 will include a survey, oral hygiene skills assessment and clinical assessment of the~          Gingival Index and Plaque Score. The survey will provide data on the conceptual domains~          that are the target of the tailored intervention~        2. T1 will follow the AMI-PM or CA+PM (depending on condition) and will include the~          survey, oral hygiene skills assessment and clinical assessment of the Gingival Index~          and Plaque Score. This assessment will occur 1-2 months after the initial intervention~        3. T2 will follow the AMI-PM or CA+PM and will include the survey, oral hygiene skills~          assessment and clinical assessment of the Gingival Index and Plaque Score. This~          assessment will occur 6 months after the initial intervention~        4. T3 will include oral hygiene skills assessment and clinical assessment of the Gingival~          Index and Plaque Score. This will occur 15-18 months after study entry. We will use~          general linear mixed models (GLMM) or general estimating equations (GEE), respectively,~          to fit a model with intervention and period effects using the MIXED procedure in SAS.~   "
48738|NCT02419131|"~     The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive~     Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of~     posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope~     to learn if a non-medication, cognitive-behavioral treatment can result in noticeable~     reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.~   "
48739|NCT02419118|"~     Daratumumab is a new treatment for patients with myeloma. While many patients benefit from~     this treatment some do not and the mechanism(s) of failure are poorly understood. This study~     aims to clarify aspects of resistance to treatment with daratumumab in order to improve~     patient outcomes in the future.~   "
48740|NCT02419105|"~     The overall purpose of this study is to test the individual and combined effect of~     transdermal testosterone and/or Vitamin D in reducing fall risk and improve function in~     pre-frail hypogonadal senior men.~   "
48935|NCT02416557|"~     Intraoperative hypothermia is associated with many clinical adverse outcomes. Many~     techniques were applied to prevent intraoperative hypothermia, and positive end-expiratory~     pressure (PEEP) has been known to blunt intraoperative hypothermia by increasing~     thermoregulatory vasoconstriction threshold. The investigators assessed the effect of PEEP~     on the prevention of intraoperative hypothermia during spine surgery in prone position.~   "
48741|NCT02419092|"~     UPDATED May 2016:~      Originally the study design included investigation of the effects of the bioactive compound~     resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having~     OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the~     investigators have found it necessary to descale the study design. Hence, we have~     discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional~     investigation of metabolic changes in subjects with and without OSA and the effect of weight~     loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial~     stiffness.~      Obstructive sleep apnea (OSA) is a common disorder especially among obese individuals and~     patients with type 2 diabetes. OSA is associated with an increased morbidity and mortality.~      Continuous positive airway pressure (CPAP) is the standard treatment. Also weight loss is~     known to reduce the severity of OSA, especially bariatric surgery has proven effective~     because of the massive weight loss.~      The investigators hypothesize that OSA via pro-inflammatory responses in various tissues~     causes low-grade inflammation which ultimately induce the associated co-morbidities. The~     investigators hypothesize that massive weight loss after bariatric surgery have beneficial~     effects on severity of OSA, inflammatory status and improves insulin sensitivity.~   "
48742|NCT02419066|"~     Determine the level, patterns, and correlates of objectively measured ART adherence in early~     and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the~     need and nature of interventions to support early ART adherence in Uganda and South Africa~   "
48743|NCT02419053|"~     The purpose of this study is to see if the surgical safety checklist is associated with a~     reduction in perioperative complications for children undergoing surgery in Ontario, Canada.~   "
48744|NCT02419040|"~     The purpose of this study is to determine whether the combination of removal of the~     calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus~     tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection~     is more effective than corticosteroid or sham injection alone.~   "
48745|NCT02419027|"~     A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the~     Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel~     Syndrome.~      Regimen: 6 probiotics mixture >10^9/D for 8 weeks~      Primary variable: visual analogue scale(VAS) assessment for abdominal pain~      Secondary variable:~        1. change of VAS score for abdominal pain/discomfort after 4/8-week treatment~        2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete~          evacuation), flatulence , feces shape, frequency of bowel movements~   "
48746|NCT02419014|"~     The purpose of this study is to assess the feasibility and effectiveness of Cranial~     Electrical Stimulation (CES) therapy in treating symptoms of Restless Legs Syndrome (RLS).~     Participants will be randomly assigned to one of three groups, a usual care (control group),~     an active CES device group and a sham (inactive) CES device group. Those who are enrolled in~     one of the device groups will not know which type of device they have (blinding). Those~     enrolled in the usual care group and sham groups will ultimately have the option to use the~     active device after they complete the study. Study length for participants is 8 weeks.~   "
48747|NCT02419001|"~     A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the~     Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult~     Subjects with a Functioning Ileostomy.~   "
48748|NCT02418988|"~     Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients'~     poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance~     to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter~     chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC.~     But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many~     advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has~     multiple anticancer functions and does not have any of the immune-inhibitory effects of~     chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and~     safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of~     advanced HCC.~   "
48749|NCT02418975|"~     Pre-operative weight loss can reduce the risk intra- and post-operative complications but no~     optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets~     (VLCDs) were proven to results in higher metabolic improvements in the short-term than~     balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a~     VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet.~     However, to achieve a optimal compliance in patients having experienced multiple dietary~     intervention failures, administration of the intervention will be performed by the enteral~     route using a naso-gastric feeding tube.~   "
48750|NCT02418962|"~     This is a single center, randomized, placebo-controlled, double-blind trial to assess the~     safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).~      The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be~     to establish whether three doses of the higher regimen - three doses of 2.7x10^5 PfSPZ of~     the PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in~     malaria exposed African adults as the five dose regimens. Specifically, the trial will~     address the following objectives: is the three dose regimen:~        1. Safe and well tolerated in Equatoguinean (EG) adults.~        2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10^5 PfSPZ in Tanzanian~          and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 PfSPZ being~          tested in Tanzanian, Malian and U.S. adults.~      In addition, as an exploratory objective, the volunteers in the EG trial will be followed~     longitudinally to measure the incidence of malaria during the initial six months following~     immunization, providing a preliminary assessment of efficacy.~   "
48751|NCT02418949|"~     This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase~     of recovery in which the combination of drug therapy (cyproheptadine) and active movement~     practice (AMP) is used to encourage increased voluntary muscle control and strength.~   "
48752|NCT02418936|"~     The purpose of this study is to develop and applicate two new genetic deafness gene~     diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.~   "
48753|NCT02418923|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine~     blood draws in neurosurgery patients.~   "
48754|NCT02418910|"~     The goal of this project is to complete the development of a patient-centered software~     system and mobile app to assist in managing bipolar disorder. In Phase I, the investigators~     developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems~     (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of~     a BD patient. Once the patient's state is identified and the trajectory of the patient is~     established, KIOS produces advice specific to the patient's condition to help manage the~     course of the disease. To demonstrate the usability of the software, KIOS was converted to~     an online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week~     field trial. No technical problems with the software were observed and results showed that~     patients had significantly more reductions in symptom severity than increases. The~     development of this innovative tool to help patients self- manage BD has the potential to~     have a profound impact on public health and achieve significant commercial success.~   "
48755|NCT02418897|"~     This pilot study will evaluate for the presence of neuromuscular junction (NMJ) defect in~     women with motor fatigue in multiple sclerosis by Single Fiber Electromyography (SFEMG)~     using the concentric needle electrode.~   "
48756|NCT02418884|"~     This study is designed to validate the hypothesis that the treatment of rosuvastatin could~     increase the score of Calcification of Coronary artery(CAC) density in coronary artery~     disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC~     will receive rosuvastatin (20mg/d) therapy for 24 months.~   "
48757|NCT02418871|"~     The objective of this study is to evaluate the clinical outcomes of an accommodating~     intraocular lens (AIOL) designed to provide distance, intermediate, and near vision in~     patients undergoing cataract extraction and intraocular lens implantation using an improved~     injector system.~   "
48758|NCT02418858|"~     Recently, there has been increasing interest in performing DBS under general anesthesia,~     where the stimulated targets are located anatomically (i.e. on MRI) rather than~     physiologically via microelectrode recordings and intra-operative test stimulation. This~     technology has been termed asleep DBS and is performed with the patient under general~     anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS~     electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical~     safety) is the surgical endpoint, there is no need for the patient to be awake during the~     procedure.~   "
48759|NCT02418845|"~     The purpose of this clinical trial is to test the safety and efficacy of the oral~     investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.~   "
48760|NCT02418832|"~     Needle aspiration of the epididymis causes rupture and irreversible damage to the duct.~     Recurring punctures and needle aspirations of fluid and tissue during Testicular Fine Needle~     Aspiration (TEFNA) procedure cause irreparable injury and loss of part of the testis'~     tubules. The hypothesis of this research is that production of sperm from the testis will be~     improved due to ultrasonically guided Rete Testis needle aspiration. In cases of Obstructive~     Azoospermia, the Rete Testis is expected to contain a large number of sperm cells. In cases~     of Non-Obstructive Azoospermia, the investigators can expect to produce sperm cells from~     aspiration of the Rete Testis, which drains all of the testis' tubules. Furthermore,~     catheterization of the Rete Testis will allow for the drainage of all testes tubules and for~     the production of sperm cells created locally in some of the tubules or in parts of them.~      The potential advantage of needle aspiration from the Rete Testis is that the procedure will~     allow for the aspiration from all the testes tubules, as opposed to the standard method of~     sperm cells production from the testis which samples only some of the tubules. Therefore, it~     is expected that the procedure suggested in this research will be more efficient than the~     standard procedures currently in practice. An additional advantage to this procedure is that~     puncture and aspiration of the tubule network is not expected to block the drainage from the~     testis, as is the case in aspiration of the epididymis, and it is also not expected to~     damage the tubules, as is the case in TEFNA and in TESE.~   "
48761|NCT02418819|"~     This study is designed to investigate the safety, tolerability pharmacokinetics and~     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets~     in subjects with schizophrenia.~   "
48762|NCT02418806|"~     An experimental study designed to test the effectiveness of a psychological intervention~     based on group therapy for the caregivers of Alzheimer's disease patients. The intervention~     consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study~     aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of~     burden after been involved in a group therapy.~   "
48763|NCT02418793|"~     The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the~     acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in~     adult subjects with moderate/severe congenital hemophilia A or B. This will be a~     single-dose, open label, dose-escalating study. Each dose cohort will be concluded by a~     safety review, following which escalation to the next dose cohort will be approved.~   "
48764|NCT02418780|"~     The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi -~     a mind-body exercise - on motor and cognitive function as well as quality of life in~     individuals recently diagnosed with Parkinson's disease (PD).~   "
48765|NCT02418767|"~     The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three~     dose levels study in healthy Caucasian and Japanese male volunteers.~      Following a 4-week screening period, eligible male subjects will be stratified by ethnic~     group and will be randomized to one of six groups. On dosing day, designated as Day 1, each~     subject will receive single SC injection of study medication according to group allocation~     and will be followed up for a month for safety monitoring.~   "
48766|NCT02418754|"~     The primary objective of the study is to explore the effect of REGN2176-3 on the Early~     Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients~     with neovascular age-related macular degeneration (AMD), compared to intravitreal~     aflibercept injection (IAI) monotherapy.~   "
48767|NCT02418741|"~     The purpose of this study is to investigate whether degree of neck flexion affect on~     laryngeal view and discomfort during endotracheal intubation in adult patients.~   "
48936|NCT02416544|"~     The aim of this study is to evaluate the effectiveness of Low Calorie Low Salt Lunch for~     Weight Reduction in overweight or obese workers of a health promoting hospital.~   "
48768|NCT02418728|"~     In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to~     co-morbidities and as a result, obesity significantly shortens life expectancy and lowers~     quality of life. To prevent this, participation in exercise or training programs is~     absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose~     tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine~     regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However,~     large variations in adipose tissue mass loss and gain are likely in obese subjects, possibly~     due to a decreased lipolytic effect of these hormones (as was shown for catecholamines in~     the subcutaneous adipose tissue of obese subjects). However, the relative contribution of~     atrial natriuretic peptide in the lipolytic process remains elusive, particularly in~     subjects with obesity, which show an increased plasma expression of atrial natriuretic~     peptide.~      The aim of the present study is to observe the contribution of atrial natriuretic peptide in~     the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of~     extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ~     at rest and during endurance exercise under local beta- and alpha-blockade.~      Eventually, the knowledge gained from this research will contribute to the optimization of~     exercise programs for people with obesity.~   "
48769|NCT02418715|"~     The aim of this study was to investigate the effects of water-based exercises on lipid~     profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.~      It was hypothesized that a water-based aerobic interval-training period would decrease~     plasma concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL~     levels, as well as maximal oxygen uptake (VO2max) values.~   "
48770|NCT02418702|"~     Depression treatment typically is slow acting. Patients presenting with acute suicidality~     have few immediate treatment options. However, sub-anesthetic doses of ketamine have been~     now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale~     showed this could be applied to suicidal patients, with 14 of 15 participants showing~     remission of suicidal thinking within 40 min of the administration of ketamine, with 13~     showing lasting remission out to 10 days. No serious side effects were reported. This~     project proposes to conduct a randomized, placebo-controlled trial of this, same~     intervention in military patients recently hospitalized for suicidal thinking. After being~     assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or~     placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely~     for 240 min after drug infusion, and the for lasting changes the next day, at hospital~     discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the~     electronic medical record for up to a year.~   "
48771|NCT02418689|"~     The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor,~     NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who~     received at least 2 prior HER2-directed regimens.~   "
48772|NCT02418676|"~     The coprecipitation method was used to prepare hydroxypropyl-beta-cyclodextrin complexed~     with insulin (HPβCD-I) by mixing insulin with hydroxypropyl-beta-cyclodextrin (HPβCD) in the~     molar ratio of 1:5 with the addition of 10 mL of purified water for every 100 mg of the~     complex. After complete dissolution of the material, the mixture was stirred for 30 min at~     room temperature (25°C), then left to rest for 60 min and lyophilized.~      The gel was prepared by dispersing the Carbopol 940® polymer in a known amount of purified~     water. Under mild heating the methylparaben (0.02%, w/v), propylparaben (0.01%, w/v) and~     propylene glycol were dissolved and incorporated in the dispersion of Carbopol 940® and left~     to rest for a period of 12h. After this time, the prepared gel was stirred and pH corrected~     to a range of 5.0 to 7.0 with triethanolamine. A set amount of insulin and the HPβCD-I~     complex were incorporated into the control gel for the preparation of other formulations.~      A randomized, double-blind, prospective clinical trial was conducted from March 2013 to~     April 2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order~     to determine the safety and efficacy of gel in patients hospitalized in the Intensive Care~     Unit.~      Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded~     from the study. Grade II pressure ulcers were selected as they are a superficial lesion,~     with little tissue loss, and allow easy visualization of healing.~      A letter of free and informed consent was obtained. The study was conducted with each~     patient for a period of 15 days.~      The volunteers were divided equally into three groups A, B and C, with each group being~     formed by five volunteers (n=5). Group A was randomly selected for treatment with gel with~     HPβCD-I complex, group B for treatment with gel with insulin, and group C with the control~     gel.~      Blood glucose tests were performed in order to assess whether the insulin complexed or~     otherwise with HPβCD could cause an increase in the rate of insulin in the blood in~     patients, leading to hypoglycemia.~      An identical standardized procedure for gel placement was used for all patients. Initially,~     the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was~     measured and photographed, as the ruler included the date and the initials of the patient.~     After measuring, a quantity of 5 grams of gel was placed on the pressure ulcer and covered~     with sterile gauze and a transparent film.~      The curative was changed once a day during the treatment period, unless there was leakage of~     fluid, contamination, or signs of infection. Every three days the pressure ulcers of all~     patients were measured and photographed again, resulting in a total of six measurements per~     patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and~     any kind of irritation. At the end of this stage, the properly gathered study data was~     interpreted using the analysis software Mobile Wound Analyzer® (MOWA).~      Data was evaluated by variance analysis (ANOVA), and means were compared with the Tukey test~     (p < 0.05) using the software Statistica 8.0/2008 (Stat Soft Inc., Tulsa, USA).~      Mixed model repeated measures methodology with some covariance structures was adopted for~     statistical analysis of the clinical trial (p < 0.05). The Statistical Analysis System (SAS)~     for Windows, version 9.3 (SAS Inc., Chicago, IL) program was used for statistical analysis.~   "
48773|NCT02418663|"~     The aim of this study is to determine the prevalence of Fluid Responsiveness (FR) (SV~     increases by at least 15% after Volume Expansion, VE) in postoperative patients admitted on~     a surgical ward after elective abdominal, thoracic and esophageal surgery~   "
48774|NCT02418650|"~     A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance~     and routes of excretion of ODM-201 in healthy volunteers.~   "
48775|NCT02418637|"~     Test the feasibility of performing worksite screening of Hypertension, Diabetes and~     Hyperlipidemia for six months~   "
48776|NCT02418624|"~     A phase I trial to determine the recommended phase two dose of the combination of~     carboplatin and olaparib.~   "
48777|NCT02418611|"~     The Zenith® Dissection Endovascular System is indicated for the treatment of patients with~     acute, complicated type B aortic dissection.~   "
48778|NCT02418598|"~     The purpose of this study is to evaluate the safety, efficacy of intra-putaminal infusion of~     AAV-hAADC-2 (adeno-associated virus encoding human aromatic L-amino acid decarboxylase) by~     stereotaxic surgery in patients with advanced Parkinson's disease.~   "
48779|NCT02418585|"~     The purpose of this study is to compare the efficacy and safety of switching~     treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to~     which they have not responded) to either intranasal esketamine plus a new oral~     antidepressant or switching to a new oral antidepressant plus intranasal placebo.~   "
48780|NCT02418572|"~     Previous work indicates that 2 months androgen pre-treatment may equip preantral follicles~     with more FSH receptors and increase the cohort of follicles surviving to the recruitable~     antral stage. In this regard it may result in an increase in the oocyte yield and the~     reproductive outcome in women with poor ovarian response. These findings provide a strong~     rationale for a definitive large RCT. The TTRANSPORT study will include 400 women with poor~     ovarian response randomized to receive pre-treatment with transdermal testosterone gel or~     placebo in order to provide conclusive evidence regarding the superiority or not of~     transdermal testosterone pre-treatment for the management of poor ovarian responders~     fulfilling the Bologna criteria.~   "
48781|NCT02418559|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     JNJ-63623872 following oral administration of single ascending dose of JNJ-63623872 in~     healthy Japanese adult participants.~   "
48782|NCT02418546|"~     This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an~     e-Health application versus in-person nutritional counseling to maintain or increase weight~     in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS),~     Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the~     feasibility, safety, tolerability and efficacy of an e-Health application to maintain or~     increase body weight compared to in-person nutritional counseling. Secondary Objectives are~     to measure the number of calories required to maintain or increase body weight in~     neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the~     effects of an e-Health application compared to in-person nutritional counseling on disease~     progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using~     the PROMIS SF v1.1 scale.~   "
49035|NCT02415257|"~     The purpose of the study is to determine whether vestibular and postural compensation~     following schwannoma surgery is improved by ablating vestibular function prior to surgery,~     even if vestibular function is absent according to modern assessment techniques~   "
48783|NCT02418533|"~     This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic~     screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to~     study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone~     (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters~     include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse~     parameters, and chromosomal aneuploidy rates after PGS.~      This pilot study is expected to significantly contribute to optimization of treatment~     regimens and stimulation protocols to optimize embryo quality.~   "
48784|NCT02418520|"~     To elucidate the relationship of chewing miswak sticks on the H. Pylori infection in the~     oral cavity.The study would be conducted at the College of Dentistry, KSAU-HS, Riyadh, KSA.~      Oral plaque samples would be obtained from those patients who are willing to participate. As~     a part of the initial screening the plaque samples would be collected and sent for screening~     of oral microbiota to the Microbiology and Biochemistry Department of College of Medicine,~     KSAU-HS, NGHA, Riyadh. Here, the basic microbial culturing (rapid urease test) would be~     performed for detecting the presence of oral H.Pylori. Volunteers who are tested positive~     for H. Pylori infection through the rapid urease test would be invited to participate in the~     study.~   "
48785|NCT02418507|"~     The primary objective for this study is to monitor the change in patient assessed symptoms~     of constipation in subjects taking the proprietary probiotic blend compared to those taking~     the placebo. The secondary objective for this study is to additionally monitor changes in~     stool consistency, stool frequency, quality of life and microbial composition of feces from~     baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood~     safety parameters as well as incidence of adverse events throughout the entire study for all~     subjects.~   "
48786|NCT02418494|"~     This research trial studies health-related symptom questionnaires in measuring quality of~     life in human immunodeficiency virus (HIV)-infected participants treated with or monitored~     for anal lesions. Collecting information and symptoms from patients diagnosed with anal~     lesions may help reduce the risk of anal cancer.~   "
48787|NCT02418481|"~     In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination~     with tumor reducing surgery, for example cryosurgery going to be investigated.~   "
48788|NCT02418468|"~     This study will compare the efficacy of indacaterol versus placebo in COPD patients~     classified as GOLD 2014 Patient Group B.~      This is a 2-arm parallel group study that will recruit COPD patients classified by GOLD~     Patient Gorup B. On successful completion of run-in period, patients will be randomized in~     the ratio 1:1 to receive prn salbutamol plus:~        1. Indacaterol 150ug or~        2. Placebo for indacaterol all od for 26 weeks. The primary objective (trough FEV1) will~          be assessed after 12 weeks.~   "
48789|NCT02418455|"~     UX003-CL203 is an open-label, multi-center, Phase 2 study to assess the safety and efficacy~     of UX003 in pediatric MPS 7 subjects.~   "
48790|NCT02418442|"~     Continuation of the CARRA Registry as described in the protocol will support data collection~     on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis~     for future CARRA studies. In particular, this observational registry will be used to answer~     pressing questions about therapeutics used to treat pediatric rheumatic diseases, including~     safety questions.~   "
48791|NCT02418429|"~     Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat~     catabolism and resting energy expenditure and decreases plasma insulin and glucose responses~     as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP).~     Consumption of whey protein has also been shown to increase energy expenditure and favorably~     affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on~     energy expenditure and gut hormones in lean and obese women and men.~   "
48792|NCT02418416|"~     Novel approach for Oocyte fertilization failure for difficult cases not respond to~     traditional methods of assisted reproduction as intracytoplasmic sperm injection.~   "
48793|NCT02418403|"~     This is a study of the effect of consumer-directed financial incentives on completion of~     advance care planning among Medi-Cal patients.~   "
48794|NCT02418390|"~     The aim of this study is to investigate the efficacy and safety of prophylactic central~     lymph node dissection in papillary thyroid carcinoma.~   "
48795|NCT02418377|"~     Obesity is a complex multifactorial disease where genetics play an important role in~     predisposing children to early onset obesity. Though many obesity susceptible genes and~     variants have been identified with obesity, the most common obesity gene, MC4R only accounts~     for 5% of all early onset obesity cases. This implies that there may be more obesity related~     genes and variants that need to be unravelled to further delineate the relationship between~     obesity and genetics. The investigators propose in screening the exonic regions of all the~     genes in obese subjects using whole-exome sequencing (WES) to discover novel obesity related~     variants and genes.~      Primary hypothesis The investigators hypothesized that our paediatric subjects with~     early-onset severe obesity will have strong genetic predisposition and therefore the cohort~     would be enriched with obesity susceptibility genetic variants.~      Secondary hypothesis The investigators hypothesized that there is increasing prevalence of,~     and possibly worsening, obesity-related complications (namely glucose intolerance,~     hypertension, metabolic syndrome, non-alcoholic fatty liver disease) in our severely obese~     children, as compared to 15 years ago, due to an increasingly obesogenic environment~     promoting unhealthy lifestyle and eating habits.~   "
48809|NCT02418195|"~     The purpose of this study is to examine whether neural-derived exosomal miRNAs are~     differentially expressed that are specific to suicidal ideation or behavior, and which by~     affecting specific miRNA targets and pathways, are associated with suicidal behavior and~     response to ketamine. The following groups of subjects will be examined: 1) major depressive~     disorder (MDD) with a recent suicide attempt (in past 2 weeks), 2) MDD with serious ideation~     (in the past 7 days) without recent suicide attempt (in the past 6 months), 3) MDD without~     clinically significant suicidal ideation (in the past 7 days) or recent suicide attempt (in~     the past 6 months), and 4) healthy controls. Both suicidal and non-suicidal MDD will be~     given ketamine (0.5 mg/kg, IV) and blood will be drawn at predose, 30 min, 180 min, 24~     hours, and 14 days post-infusion to measure changes in miRNAs.~   "
48796|NCT02418364|"~     Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the~     end. It is often said that the couple suffers from infertility if for a year they could not~     get a normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30%~     are attributed to men, while the other 40% of cases are attributed to the combination~     between men and women and for unknown reasons. In women, the source of most of the problems~     of infertility are associated with different failures in ovulation (early ovulation, lack of~     ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to~     endometriosis, infection or surgery), problems in the uterus and endometrium. There is a~     group of women that apparently does not have the failures described above, and they have~     infertility that does not include pathological findings. Apparently chronic stress is a~     potential cause among couples who could not get pregnant (despite 6 months of focused sex)~     so there is a request for various techniques for reducing stress including yoga and~     meditation. One common option in various conditions of infertility is in vitro~     fertilization. This technique is also known as artificial insemination and is the most~     common technique used in Israel. Data from the Ministry of Health from the last years,~     indicate that the rate of successful pregnancies after embryo transfer is more than a third~     (in average), this is from an average of 20 treatment cycles.~      Researches in alternative medicine are not easy to carry out. The placebo group which is~     usually the control group tend to be a treatment group by itself and gives effective results~     than a group that does not receive treatment at all. Carrying out a strict study with a good~     control group such as reflexology research in multiple sclerosis, has brought significant~     results in various statistical measures examined in this study (movement, sensory mode and~     urinary tract symptoms).~      In the control group the calf was chosen as a place of a massage as a dummy treatment~     (gynecological place), which prevented contact with specific points of the feet like in~     patients in the treatment group. This study wishes to answer the research question: Does~     reflexology treatment increase the chances of pregnancy implantation in women without~     pathological findings that are treated with IVF. Other questions related to measures that~     could lead to the implant of pregnancy, are whether reflexology treatment affect the~     endometrial thickness, number of oocytes and embryo quality. Literature indicates the~     potential of reflexology treatment on ovulation induction (But requires a good control group~     and large sample size).~   "
48797|NCT02418351|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI).~   "
48798|NCT02418338|"~     Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain~     evaluation in Duchenne muscular dystrophy children versus a control group.~   "
48799|NCT02418325|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI)~   "
48800|NCT02418312|"~     Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains~     unclear.~   "
48801|NCT02418299|"~     The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser~     therapy in treating female stress and mixed urinary incontinence.~   "
48802|NCT02418286|"~     The Purpose of this trial is to define the characteristics of the patients with low back~     pain in oriental rehabilitation clinic. This information will create a registry that will~     help us to compare similarities and differences in patients and their symptoms. The more~     patients the investigators are able to enter into the registry, the more the investigators~     will be able to understand the low back pain and learn better ways of caring for patients.~   "
48803|NCT02418273|"~     The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in~     children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2,~     randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone~     resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age~     4 to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid~     regimen. Primary outcomes include suppression of bone turnover markers and safety~     assessments. Secondary outcomes include changes in bone density as measured by dual energy~     X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT)~     densitometry at the radius and tibia.~   "
48804|NCT02418260|"~     This study intends to determine the best surgical treatment for humeral shaft fractures. One~     third of the patients will be treated with open reduction and internal fixation with plate;~     one third, with bridge plate technique and the remaining third with locked intramedullary~     nail.~   "
48805|NCT02418247|"~     The researchers investigated the rate of biochemical remission in patients without~     radioactive iodine therapy compared to patients with low dose radioactive iodine treatment~     in differentiated thyroid cancer patients who underwent total thyroidectomy.~   "
48806|NCT02418234|"~     The purpose of this study is to compare the frequency and abundance of T790M mutation among~     the different Clinical modes of EGFR-TKI failure.~   "
48807|NCT02418221|"~     This study aims to define a provocation test for histamine intolerance (aka. biogenic amine~     intolerance syndrome) and test the capability of an oral enzyme supplementation to~     ameliorate this condition.~   "
48808|NCT02418208|"~     Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked~     response potentials in adolescents, young adults and Adults.~      Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to~     1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be~     followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient~     population: Adolescents, young adults and Adults of both genders.~      Age range:~        -  10-11.99~        -  12-13.99~        -  14-15.99~        -  16-17.99~        -  18-24.99~        -  25-29.99~        -  30-34.99~        -  35-39.99~        -  40-44.99~        -  45-49.99~        -  50-54.99~        -  55-60~        -  60 and above~      Objective: Establishment of normative data of BNA.~   "
48823|NCT02418013|"~     This study aims to carry out a safety evaluation of human cord blood and frozen plasma as~     treatment for pre-frailty , to assess whether the treatment can prevent and improve the~     aging process, and to identify useful clinical markers of frailty.~      The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial~     conducted at CHA clinical trial institute.~   "
48810|NCT02418182|"~     Current standard of care is no pretreatment medications before the egg retrieval, and the~     investigators would like to evaluate if preoperative Tylenol improves procedure and post~     procedure pain control over the current practice (no pre-treatment). Specifically, this~     study will compare Tylenol with a placebo when given before retrieval procedures. The~     investigators believe that if Tylenol can offer better analgesic relief than no pretreatment~     medications, then it may reduce the amount of narcotics needed by patients during and after~     the procedure and contribute to better patient satisfaction. . This study will enroll 100~     participants all from UAB.~   "
48811|NCT02418169|"~     This study evaluates the association between traumatic brain injuries and craniofacial~     or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve~     primary diagnostics of trauma patients.~   "
48812|NCT02418156|"~     Objective is to actively gather information on the use of CorMatrix ECM for vascular repair~     in the reconstruction of the femoral artery.~   "
48813|NCT02418143|"~     Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a~     post market observational study.~   "
48814|NCT02418130|"~     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy~     and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.~   "
48815|NCT02418117|"~     The investigators' aim is to evaluate the accuracy of the stereolitographic template~     comparing the final implant insertion to the planned implant position at coronal and apical~     level.~      Clinical relevance:~        -  To identify factors influencing the surgical template imprecision.~        -  To overcome risk factors for surgical template imprecision.~        -  To suggest improvements for highly accuracy of the surgical template especially for~          immediate loading and avoiding the injury of anatomical structures.~   "
48816|NCT02418104|"~     This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess~     immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701~     compared with two sequential 6 mg SC injections of Neulasta®.~   "
48817|NCT02418091|"~     This study will build a population management system Simultaneous risk factor control using~     Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP~     and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition,~     the study will evaluate the feasibility of future large-scale intervention to slow diabetic~     kidney disease (DKD) DKD progression.~      Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using~     existing electronic health record data in an integrated data warehouse (Southeastern~     Diabetes Initiative- SEDI) to screen all patients within SEDI.~      Aim 2: Implement an intervention designed to slow progression of DKD and treat associated~     conditions in a high-risk population with moderate DKD and uncontrolled HTN using the~     STOP-DKD APP~        -  Primary Outcome: Test the hypothesis that patients who receive the intervention will~          have greater improvements in blood pressure as compared to a control group after 6~          months~        -  Secondary Outcomes: Exploratory analyses to determine whether patients who receive the~          intervention will have less progression (defined as a smaller decrease in kidney~          function), and improved behaviors that affect HTN control and cardiovascular risk~          (medication adherence, diet, physical activity, and weight control) as compared to a~          control group after 6 months~      Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation & dissemination~        -  Impact Evaluation: Assess the potential population impact of our intervention using the~          Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework~        -  Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by~          estimating projected costs and quality-adjusted life-years~   "
48818|NCT02418078|"~     The aim of this study is to compare the geriatric patients with the non-geriatrics~     undergoing outpatient unilateral herniorrhapy in terms of local anesthesia, sedation,~     recovery and early morbidity.~   "
48819|NCT02418065|"~     The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach~     including exercise training program with ergocycle during dialysis sessions, oral~     nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life~     of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.~   "
48820|NCT02418052|"~     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of~     cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and~     effective management for resectable EC. Gastric tube is considered to be an ideal substitute~     for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive~     tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored~     and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a~     standard post-operative posture after tracheal resection and reconstruction, and aimed to~     relieve the anastomotic tension. In this study, the investigators attempt to adopt the~     maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing~     the incidence of CAL.~   "
48821|NCT02418039|"~     A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy~     will be recruited. They will be randomized to receive high protein diet ( n = 40) and a~     normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an~     external monitor and will keep the secret codes until the end of the study. All patients~     will be provided with structured menus and two snacks a day as an amaranth protein~     supplement. The supplement will content the same amount of fiber but the protein content~     will vary depending on the group to which the patient is assigned.~   "
48822|NCT02418026|"~     Cesarean section rates continue to increase worldwide, particularly in middle- and~     high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section~     is a particular way of giving birth, sometimes desired, but sometimes feared. If some women~     do not feel affected by this way of giving birth, it is more difficult for others to live~     with. In this way, not being able to give birth trough natural way may be disturbing in~     motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained~     according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia~     department and a committee oversees the hypnotherapist activities in pain management. The~     objective of the present study is to assess the benefit of hypnosis session for improving~     experience and reducing anxiety in women giving birth through surgery.~   "
48824|NCT02418000|"~     This is a Phase 1/2a dose-escalation study of E6201, a dual MEK1 and FLT3 inhibitor, in~     subjects with advanced hematologic malignancies with documented FLT3 mutation. The Phase1~     portion of the study will be a safety run-in (up to 30 subjects) to establish a recommended~     Phase 2 dose (RP2D). The Ph. 2a portion of the study will evaluate two specific patients~     groups: Cohort 1 will enroll up to 26 patients with relapsed or refractory AML and confirmed~     FLT3 mutation (with or without a Ras mutation) without prior exposure to a FLT3 inhibitor~     while Cohort 2 will enroll up to 26 patients with relapsed or refractory AML and confirmed~     FLT3 mutation (with or without a Ras mutation) with prior exposure to a FLT3 inhibitor.~     Cohort 3 will enroll up to 10 patients with relapsed or refractory AML with a confirmed Ras~     mutation and no FLT3 mutation. Cohorts 1 and 2 of the expansion phase will incorporate a~     Simon 2-stage optimal design. A total of up to N=92 subjects will be enrolled in the study.~   "
48825|NCT02417987|"~     The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to~     compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in~     combination with eccentric training to placebo treatment (sham treatment combined with~     eccentric exercises).~      Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5%~     bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4~     mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training~     program and examinations will be done at baseline (before treatment) with follow-ups after 6~     weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and~     differences between groups (HVI, ACP and Plc)~   "
48826|NCT02417974|"~     The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the~     risk of endoscopic recurrence of CD in patients after intestinal resection. The specific~     outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3)~     safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT~     will prevent establishment of pro-inflammatory microbiome after surgery, leading to a~     reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that~     FMT will be safe and well-tolerated in these patients.~   "
48827|NCT02417961|"~     The purpose of the study is to assess functionality, performance, and reliability of an~     accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in~     an at-home setting reported by the patient or caregiver, and to confirm the safety and~     clinical benefit of benralizumab administration in asthma patients with severe asthma.~   "
48828|NCT02417948|"~     This randomized clinical trial uses an educational brochure and online tutorial program to~     assess sun-protective behavior and skin self-examination among African Americans. Skin~     cancer is very common among African Americans, with a disproportionately high mortality~     rate. Providing a brochure and an online educational program about sun-protective behaviors~     may encourage African Americans to take preventative measures against skin cancer, help~     improve early skin cancer detection, determine how far the disease has spread, and plan the~     best treatment.~   "
48829|NCT02417935|"~     The main purpose of this study is to evaluate the effectiveness and safety of the study drug~     known as duloxetine in participants with diabetic peripheral neuropathic pain.~   "
48830|NCT02417922|"~     The purpose is to see if Autologous Conditioned Plasma (ACP) promote and accelerating tendon~     tissue healing in Conservative treated total Achilles Tendon Tears.~      40 healthy males were randomized to either receive ACP or Placebo (saline) around the~     ruptured achilles tendon at baseline, 2 weeks, 4 weeks and again after 6 weeks during the 8~     weeks immobilization period with an orthosis. Ultrasound and symptoms scores (ATLS) was~     performed at baseline, after 8 weeks immobilization and again after 3 month, 6 month and 12~     month. Scoring and functional tests was performed after the 8 weeks immobilization and again~     after 12 weeks, 24 weeks and 52 weeks from injury date.~   "
48831|NCT02417909|"~     Obesity is a major public heath issue. It may have various impacts on a patient's life by~     causing psychological problems, altering a patient's quality of life,etc. These led to the~     investigators' hypothesis which is examining the psychological dimensions of a teenager~     suffering for obesity.~   "
48832|NCT02417896|"~     Our aim is to test whether short term perioperative administration of oral spironolactone~     could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical~     patients.~   "
48833|NCT02417883|"~     In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the~     glomerulus was considered to have the main importance. Kidney's tubular atrophy and~     interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate~     the function of the kidney's tubule-interstitium through furosemide excretion after~     intravenous administration of this drug, and correlate the rate of excretion of furosemide~     with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic~     kidney disease.~   "
48834|NCT02417870|"~     To investigate the safety and tolerability of treatment with low dose rIL-2 in renal~     transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal~     transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant~     recipients.~   "
48835|NCT02417857|"~     The aim of this study is to compare outcomes of quality-of-life measures and evaluate the~     body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and~     Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30~     underwent LC.Fifty-eight patients were included the study and divided into two groups. The~     results of the questionnaires were statistically compared.~   "
48836|NCT02417844|"~     Two tamsulosin HClformulations will be tested in fed state~   "
48837|NCT02417831|"~     A bio-equivalence of 2 different capsule formulations in fasted subjects~   "
48838|NCT02417818|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and~     improving microcirculation. Although previous studies indicate that Plasma Therapy can~     accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of~     action. Therefore, the aim of this study is to evaluate the microcirculatory effects of~     Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic~     wounds in a human in-vivo setting for the first time.~   "
48839|NCT02417805|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds and chronic wounds aim at reducing infection and improving~     microcirculation. Although previous studies indicate that remote ischemic preconditioning~     (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its~     mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory~     effects of remote ischemic preconditioning on second-degree burns, superficial and chronic~     wounds in a human in-vivo setting for the first time.~   "
48840|NCT02417792|"~     At least 20 psoriasis patients will be compared to at least 20 participants without~     psoriasis Bacterial genomic DNA will be extracted from stool samples of participants. The~     intestinal bacterial populations will be compared in order to examine whether there are~     differences between the groups.~   "
48841|NCT02417779|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing~     infection and improving microcirculation. Although previous studies indicate that~     extracorporeal shock wave therapy (ESWT) can accelerate wound healing, only a few studies~     focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is~     to evaluate the microcirculatory effects of extracorporeal shock wave therapy on~     second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds~     in a human in-vivo setting for the first time.~   "
48842|NCT02417766|"~     Background:~      - There are many types of immune disorders. These range from rare immune deficiencies to~     allergies to autoimmune disease like rheumatoid arthritis. Genes are the instructions our~     body uses to work and develop. A new technology called whole exome sequencing may help find~     the cause of these disorders. Whole exome sequencing is a way to look at many genes at once~     for errors. Researchers hope to find new gene changes that lead to immune disorders.~     Additionally, researchers are interested in finding the best way to manage unexpected but~     important findings by whole exome sequencing.~      Objectives:~      - To better understand genetic causes of immune system disorders. Also, to better understand~     people s thoughts and feelings about immune system disorders and new genomic testing.~      Eligibility:~      - People ages 0 100 with an immune disorder or a relative with an immune disorder. People~     must be at least 2 to be evaluated at the NIH clinical center. People must be at least 12 to~     do the survey/interview portion of the study.~      Design:~        -  Participants will have their genes sequenced. They may be asked for a new sample of~          blood.~        -  If participants cannot come for a study visit, they can have a blood sample collected~          by their local lab or doctor and sent by mail.~        -  Researchers may or may not find the cause of the participant s immune disorder.~          Participants will learn that information. Some participants may be asked to return to~          NIH to get results and have more tests.~        -  Researchers may share information with other studies. The data will be anonymous.~        -  For the survey part of the study, participants will answer questions about their or~          their relative s immune disorder. They will also answer about their thoughts and~          feelings about genomic testing.~        -  Some participants will be asked for a brief interview to ask more about the survey~          topics. There may be more follow-up after several months.~   "
48843|NCT02417753|"~     Background:~      - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid~     built up in the abdomen. Researchers want to see if a new drug can affect some of the immune~     cells in the ascites. This may also treat the cancer.~      Objective:~      - To look at the immune markers the ascites of people with gastrointestinal or ovarian~     cancer.~      Eligibility:~      - Adults age 18 and older with a malignancy of the GI tract or metastatic ovarian cancer. As~     a result, they have ascites in the abdomen.~      Design:~        -  Participants will be screened with:~        -  Medical history, physical exam, and blood tests.~        -  Echocardiogram: sound waves make images of the heart.~        -  Electrocardiogram: measures electrical activity of the heart.~        -  Paracentesis: a needle will be inserted in the abdomen and will remove some of the~          ascites fluid.~        -  They may have a tumor biopsy.~        -  Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in~          cycle 1 and 4 times all other cycles. Each cycle is 28 days.~        -  Each cycle, participants will:~        -  Have a physical exam.~        -  Have blood tests weekly.~        -  Be asked about how they feel and any medicines they are taking.~        -  After every 2 cycles (about every 2 months), participants will have scans and x-rays of~          their tumor.~        -  Participants will have paracentesis 2 more times during the study. They will have~          another echocardiogram.~        -  At the end of therapy, participants will have a physical exam and blood tests. They~          will be asked about how they feel and any medicines they are taking.~   "
48844|NCT02417740|"~     Background:~      - Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure~     in the blood vessels of the liver. It seems to start slowly and not have many warning signs.~     Many people may not even know that they have a liver disease. There are no specific~     treatments for NCPH.~      Objectives:~      - To learn more about how NCPH develops over time.~      Eligibility:~      - People age 12 and older who have NCPH or are at risk for getting it. In the past year,~     they cannot have had other types of liver disease that typically result in cirrhosis, liver~     cancer, or active substance abuse.~      Design:~        -  Participants will have 2 screening visits.~        -  Visit 1: to see if they have or may develop NCPH.~        -  Medical history~        -  Physical exam~        -  Urine and stool studies~        -  Abdominal ultrasound~        -  Fibroscan. Sound waves measure liver stiffness.~      <TAB>- Visit 2:~        -  Blood tests~        -  Abdominal MRI~        -  Echocardiogram~        -  Questionnaire~        -  Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This~          is done with a small tube inserted in a neck vein.~        -  They may have a liver biopsy.~        -  All participants will visit the clinic every 6 months for a history, physical exam, and~          blood tests. They will also repeat some of the screening tests yearly.~        -  Participants with NCPH will also have:~        -  Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and~          stomach.~        -  At least every 2 years: Esophagogastroduodenoscopy.~        -  At least every 4 years: testing including HVPG measurements and liver biopsy.~        -  Participants without NCPH will also have:~        -  Liver biopsy and HVPG measurements to see if they have NCPH.~        -  Every 2 years: abdominal MRI and stool studies.~        -  The study will last indefinitely.~   "
48845|NCT02417727|"~     Background:~      - Some people with movement disorders are in another NIH protocol. They will have electrodes~     placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers~     want to learn more about how brain cells and networks work while people learn and remember.~     They want to use the data from the other NIH study to do this.~      Objective:~      - To share data from before and during deep brain stimulation surgery. The data will be used~     in a study of how the brain learns and remembers.~      Eligibility:~      - People at least 18 years old who are in protocol 11-N-0211 and have certain movement~     disorders.~      Design:~        -  As part of protocol 11-N-0211, data on participants brainwave activity is collected. In~          this protocol, they will have that data stored and shared.~        -  Researchers will access imaging data from deep brain stimulation surgery.~        -  Researchers will access other medical records.~   "
48867|NCT02417441|"~     The purpose of the trial is to record the use of the medical device EEVA™ (Early Embryo~     Viability Assessment) by comparing the rate of implantation of transferred embryos selected~     using the scores from the device EEVA™ plus morphology grading versus transferred embryos~     selected using the morphology grading only.~   "
49036|NCT02415244|"~     The aim of this prospective observational study is to assess whether transesophageal~     echocardiography (TEE) can be used to identify the structures within the vertebral foramen~     of the spinal column and to determine the range of spinal segments which can be visualized.~   "
48846|NCT02417714|"~     Background:~      - Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses~     radiation to do that. In 2011, about 85.3 million CT scans were done in the United States.~     But there is growing concern about the health effects of radiation. There are new and~     different ways to make CT pictures that use less radiation. Researchers want to learn~     whether these new methods create images that are similar to images from a traditional CT.~      Objective:~      - To learn if new CT imaging methods with less radiation make images that are similar to~     traditional ways.~      Eligibility:~      - Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and~     pelvis with contrast.~      Design:~        -  Researchers will review participants medical records to see if they can be in this~          study.~        -  Participants may have blood drawn from an arm vein by a needle stick. The blood will be~          used to make sure they can be in this study and that it is safe for them to have~          contrast.~        -  During the participants CT scan appointment, one extra scan will be done using low~          radiation methods.~        -  During a CT scan, the participant lies on a table. A large x-ray machine takes pictures~          of the body.~   "
48847|NCT02417701|"~     This phase II trial studies how well target of rapamycin complex 1/2 (TORC1/2) inhibitor~     MLN0128 works in treating patients with lung cancer that is stage IV or has come back~     (recurrent) and has a mutation in the nuclear factor, erythroid 2-like 2 (NFE2L2) or~     kelch-like ECH-associated protein 1 (KEAP1) gene. Damage to these genes may cause the cancer~     to grow. TORC1/2 inhibitor MLN0128 may stop this from happening by blocking enzymes.~   "
48848|NCT02417688|"~     To demonstrate feasibility of imaging Cu[64]-25%-CANF-Comb uptake in the atherosclerosis of~     the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in~     comparison to the carotid artery for which intervention is not planned.~   "
48849|NCT02417675|"~     The Western Cape province of South Africa (SA) is changing the way it treats pregnant women~     with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are,~     will receive antiretroviral treatment (ART) for life (Option B+). However, there are few~     well-developed models of service delivery to support this change to Option B+ in the~     Western Cape and many parts of the continent.~      The parent study -- Strategies to Optimize ART Services for Maternal & Child Health~     (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To~     complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are~     an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs~     have been used to free up space at ART clinics by moving stable HIV+ patients to~     community-based services, but they have not been studied as an effective strategy among~     breastfeeding women after delivery. PACER seeks to address this gap.~   "
48850|NCT02417662|"~     The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard~     chemotherapy in patients with oligometastatic non-small cell lung cancer. Patients will be~     randomised to receive either standard treatment alone (platinum-based doublet chemotherapy)~     or standard treatment with conventional radiotherapy (RT) and SABR.~   "
48851|NCT02417649|"~     Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often~     resulting from common bacterial infections. Enhancing the immune response in these patients~     may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial~     Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore~     help significantly to the control of relapse in these patients.~      In the current study the effect of the administration of the PBML to patients older than 40~     years, with moderate, severe or very severe COPD, in good or discrete physical condition on~     the number of relapses in an observation period of 12 months. In addition, the effect of the~     PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of~     other drugs, on the number of days of absence of work, on the number of hospitalizations and~     duration thereof and on potential toxicity of the treatment.~   "
48852|NCT02417636|"~     PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on~     Patient and Process Outcomes in Uganda~   "
48853|NCT02417623|"~     AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss~     smartphone application targeted to young people aged 18 to 40 years.~      DESIGN: Randomisedclinical trial.~      SETTING: Primary Health Care centres (PHCCs) in Catalonia.~      PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting~     PHCCs for any reason and who provide written informed consent to participate in the trial.~      INTERVENTION GROUP will receive a 12-month weight loss programme that implements~     recommendations of a Clinical Practice Guideline, complemented with a smartphone app~     designed specifically for this programme.~      CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12~     months.~      EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group~     than in control group.~   "
48854|NCT02417610|"~     The purpose of the study is to assess the validity of the polynucleotide within the intra~     articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic~     acid, the most commonly used.~   "
48855|NCT02417597|"~     This phase IV clinical study was designed to evaluate the safety and immunogenicity of the~     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,~     in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will~     receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month~     schedule.~   "
48856|NCT02417584|"~     The aim of the study was to determine the long term effects of compliance with positive~     airway pressure therapy on blood pressure in both hypertensive and normotensive patients~     with obstructive sleep apnoea hypopnoea syndrome.~   "
48857|NCT02417571|"~     Control of blood pressure (BP) is the first thing to do in the management of chronic kidney~     disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to~     assess BP correctly during the office visit. Often there is a discrepancy between office BP~     and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as~     many as 34% of Korean CKD patients had masked hypertension, which means high BP by~     ambulatory BP monitoring but normal BP by conventional office BP measurement.~      This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical~     outcome of CKD, compared to the conventional management using office BP.~   "
49037|NCT02415231|"~     The study is to see if watching humor and laughing can affect CRP levels in healthy~     individuals. This is a randomized controlled trial.~   "
48858|NCT02417558|"~     The study involves a novel Virtual Reality Interface that offers full-body immersion~     Alterniity AR and more specifically computer exercises blended with game activities. It~     was hypothesized that Alterniity AR facilitated, game blended cognitive and/or physical~     exercise improves global cognition when compared to control groups; moreover, these~     improvements may be manifested by brain activity changes. The investigators explore here the~     impact of potential moderators on combined exercise-induced cognitive benefits, as well as,~     individual/separate training schemes.~      In addition, the proposed study will provide Alterniity AR in a closed feedback loop with a~     direct, reliable, and non-invasive method for assessing changes in brain activity associated~     with elderly in risk of dementia. The paradigm for the current study will combine~     neurophysiological knowledge with mathematical signal processing and pattern recognition~     methods to temporally and spatially map brain function, connectivity and synchronization.~   "
48859|NCT02417545|"~     The aim of this study is to assess the differences in gaze and gait during the stair and~     ramp negotiation (+transition to normal level walking) between healthy controls and~     vestibular patients (fallers and non-fallers).~   "
48860|NCT02417532|"~     Prospective, Open label, single arm, non-randomized, non-comparative registry study of~     Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in~     patients with Spinal cord or other injury preventing unsupported patient ambulation.~   "
48861|NCT02417519|"~     Chlorogenic acid (CGA) in coffee may lower the postprandial glucose response. CGA is~     destroyed by dark roasting. In a controlled crossover trial, 11 healthy fasted volunteers~     consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30~     min later by a 75-g oral glucose tolerance test (OGTT). Plasma glukose and insulin,~     appetite, and plasma and urine metabolic profiles will be analysed. The primary aim is to~     investigate whether roasting affects the postprandial glucose area under the curve (AUC).~   "
48862|NCT02417506|"~     The repetitive motions associated with active life and many sports can increase the wear and~     tear to the joints that leads to decrease in flexibility and joint pain finally heading its~     way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that~     supports and cushions the joints of hands and knees, causing bones to rub against each~     other. Injuries stemming from repetitive motions can also cause and worsen the joint pain.~      Joint pain is discomfort that arises from any joint . Irrespective of the underlying~     mechanisms, joint pain usually originates in activation of nociceptors, or free nerve~     endings. Complex neuronal activation occurs, which involves not only local sensitization of~     joint nociceptors but also modifications in central pain pathways.~      Even though, the numerous pharmacological interventions are available for joint pain, there~     is much debate amongst clinicians about the best approach to the treatment of joint pain.~     NSAIDs which is frequently used for treatment in such cases, carries concerns related to~     gastro-intestinal system, cardiovascular system as well as central nervous system .~      Hence there is a need of a safer alternative treatment option for relieving acute joint pain~     which is comparable to the modern medicines, without posing concerns to the subject's~     general well being.~      Herbs are known to be used since ages in traditional literature and do not pose any~     potential health concern. Inspite of such positive attributes herbs are not employed in~     treatment of acute pains as there is lack of evidence proving the same.~      In order to address the need of the hour Enovate Biolife has invented a novel poly herbal~     formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with~     osteoarthritis has been proven efficacious . It has a good history of marketing and is sold~     in the United States, with no reported adverse event related to the product. However there~     is no concrete evidence proving the product's acute pain relieving dynamics, hence the~     current study has been employed to comprehend the effect of lanconone in joint acute pain.~   "
48863|NCT02417493|"~     The purpose of the present study is to determine if asking adolescent patients (ages 13-17)~     to self-inject an empty syringe into their thigh during routine clinic visits results in~     increased reported comfort with self-injection, reduced anxiety regarding self-injection and~     food allergy management for both patient and caregiver(s), and in greater perceived~     likelihood of epinephrine self-injection, in the event of an emergency.~   "
48864|NCT02417480|"~     This study will pilot test the use of two mHealth devices. One is called the Bite Counter~     and one is called a MisFit. The study will be among a sample of participants (n = 50) to~     monitor their eating and sleeping habits. The Bite Counter is a wearable watch-like device~     that detects and records when an individual has taken a bite of food. The benefit of using~     the Bite Counter is that it places a low-burden on participants to self-monitor their~     dietary intake. The MisFit is a commercial device that tracks an individual's sleeping and~     activity.~      The purpose of this study is to (1) find out how the Bite Counter calculates daily bites~     taken on a vegan diet compared to an omnivorous diet, (2) examine differences in sleep and~     activity between individuals following a vegan diet compared to an omnivorous diet and (3)~     get feedback from users before the device is tested in larger studies.~   "
48865|NCT02417467|"~     Smoking-related diseases contribute to the death of more than 37,000 Canadians annually. Of~     that number, almost one-third die of cardiovascular-related causes. Smoking cessation can~     decrease the additional risk of heart disease by 50% after 1 year. However, even using~     smoking cessation therapies, only 10-20% of smokers will be able to successfully quit~     smoking long-term. Therefore, new and alternative treatments are needed.~      The e-cigarette is a battery-powered device approximately the size and shape of a cigarette~     that creates a smoke-free vapour which is inhaled by the user. Since it feels like smoking a~     cigarette, using the e-cigarette may help some smokers quit. Some e-cigarettes also contain~     nicotine, which can reduce withdrawal symptoms from quitting smoking. However, e-cigarettes~     have not been approved for use for smoking cessation by Health Canada or the FDA. Despite~     this, these devices are rising in popularity. A recent US Centers for Disease Control survey~     found that of smokers who were motivated to quit within the next 6 months, 48.5% had tried~     e-cigarettes.~      The Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial will be the~     first large trial to address the important issue of e-cigarettes for smoking cessation in~     Canada. The trial will randomly assign participants to receive nicotine e-cigarettes and~     minimal counseling, non-nicotine e-cigarettes and minimal counseling, or only minimal~     counseling for 12 weeks. Participants will then be followed for one year to see which (if~     any) group is more likely to have quit or reduced their smoking. Information about potential~     side effects and safety will also be collected. The E3 Trial will provide law-makers and the~     public with important information about the use of e-cigarettes for smoking cessation.~   "
48866|NCT02417454|"~     The purpose of this study is to investigate the effects of a probiotic blend on qualitative~     (subjective interviews and self-reporting) and quantitative (changes in brain activity,~     heart rate, cortisol, and reactivity) measures of stress in healthy undergraduate students.~   "
48932|NCT02416596|"~     The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the~     IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary~     infertility.~   "
48868|NCT02417428|"~     The main objective of this study is to determine if oral supplementation of Citrulline, when~     combined with HIIT, can produce significant changes in body composition, muscle quality,~     muscle metabolism and functional capacity in older obese men and women .~      The investigators hypothesize that Citrulline combined with HIIT will be more beneficial~     than HIIT alone which will be more beneficial than citrulline alone which will be more~     beneficial than placebo alone in obese elderly men and women .~   "
48869|NCT02417415|"~     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low~     blood pressure on standing), and at least half of them also have high blood pressure while~     lying down (supine hypertension). Exposure to heat, such as in hot environments, often~     worsens their orthostatic hypotension. The causes of this are not fully understood. The~     purpose of this study is to evaluate whether applying local heat over the abdomen of~     patients with autonomic failure and supine hypertension would decrease their high blood~     pressure while lying down. This will help us better understand the mechanisms underlying~     this phenomenon, and may be of use in the treatment of supine hypertension.~   "
48870|NCT02417402|"~     The aim of this trial is to investigate if patients treated by physical therapists who~     received an update on clinical practice guidelines and pain management have better outcomes~     than patients treated by physical therapists who did not received such training.~   "
48871|NCT02417389|"~     To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus~     alendronate in controlling bone loss induced by primary hyperparathyroidism.~   "
48872|NCT02417376|"~     The purpose of this study is to determine whether scaling and root planing as a periodontal~     intervention helps in improving the overall health of patients suffering from coronary heart~     disease.~   "
48873|NCT02417363|"~     Analysis of inflammatory markers in periodontitis and patients with early and middle stage~     renal disease.~   "
48874|NCT02417350|"~     The investigators planned study is a randomized, controlled exploratory study of a ketogenic~     and a NFA (National Food Administration) recommended diet. Study participants will be female~     nutrition students with both knowledge and interest in dietary surveys, in order to increase~     motivation and adherence. They will be provided with cooked food. The women should be weight~     stable and maintain their physical activity during the study, in order to evaluate how the~     diet itself affects various health parameters. The investigators intend to investigate diet~     specific biomarkers (small molecules involved in metabolism) in the blood, as well as blood~     lipids, body composition, gut microbiota, energy substrate utilization, exercise~     performance, resting metabolic rate, hormones, cognition and sweet cravings. In addition,~     the investigators intend to qualitatively study the experience of following both of these~     dietary regimes. The investigators intend to make a short and controlled study. The study is~     expected to reveal whether the ketogenic diet is a healthy or unhealthy diet in the short~     term. The investigators also expect that data from this study will be a helpful tool to~     measure diet adherence in future long-term studies.~   "
48875|NCT02417337|"~     Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics~     are needed to diminish the pain [1]. Development of pain after completion of root canal~     treatment may undermine patients' confidence in the procedure and the clinician [2].~     Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic~     medications for dental pain. Their popularity attributed to their efficacy in relieving pain~     and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a~     low effect on dental pain. Improvement was performance by combining analgesics with~     different mechanisms of action without raising any adverse effects [4], was effective in~     controlling moderate to severe pain. The combination of a non-steroidal anti-inflammatory~     drug (NSAID) and paracetamol has shown additive analgesia for treating dental pain in~     several studies [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is~     usually the treatment of choice. There have been no controlled dental studies evaluating the~     additive effects of combining a non-steroidal anti-inflammatory drug with paracetamol.~     Breivik et al [6] & Menhinick et al [7] found that a combination of acetaminophen and~     ibuprofen was more effective than ibuprofen alone in managing postoperative pain. Aim of the~     present study, to evaluate the efficacy of the paracetamol when used alone and in~     combinations with three groups of drugs to control postoperative endodontic pain.~   "
48876|NCT02417324|"~     The I-HIT-MED registry registers clinical of children and adults with medulloblastoma,~     ependymoma, pineoblastoma, or CNS-primitive neuroectodermal tumour (CNS-PNET) in Germany and~     other countries that fulfil national ethic requirements for participation in this registry.~     These tumours are rare diseases, and many patients are treated outside of clinical trials.~     The I-HIT-MED registry allows collection of data und biological material from those~     patients, and provides a basis for standard treatment recommendations and counselling. It~     aims to improve the international cooperation and the medical knowledge in these rare~     diseases. Within the I-HIT-MED registry, it is a goal to maintain and improve networks for~     quality assurance in national groups where they are already established, and to support the~     implementation in national groups, where there is no quality assurance network yet.~   "
48877|NCT02417311|"~     Heart failure (HF) is the common end-stage of different medical conditions. It is the only~     growing cardiovascular disease and its prognosis remains worse than that of many~     malignancies. The lack of evidence-based treatment for patients with diastolic HF (HFpEF)~     exemplifies that the current one for all therapy has to be advanced by an individualized~     approach. Inherited cardiomyopathies can serve as paradigmatic examples of different HF~     pathogenesis. Both gain- and loss-of-function mutations of the same gene cause disease,~     calling for disease-specific agonism or antagonism of this gene´s function. However,~     mutations alone do not predict the severity of cardiomyopathies nor therapy, because their~     impact on cardiac myocyte function is modified by numerous factors, including the genetic~     context. Today, patient-specific cardiac myocytes can be evaluated by the induced~     pluripotent stem cell (hiPSC) technology. Yet, unfolding the true potential of this~     technology requires robust, quantitative, high content assays. The researchers' recently~     developed method to generate 3D-engineered heart tissue (EHT) from hiPSC provides an~     automated, high content analysis of heart muscle function and the response to stressors in~     the dish. The aim of this project is to make the technology a clinically applicable test.~     Major steps are (i) in depths clinical phenotyping and genotyping of patients with~     cardiomyopathies or HFpEF, (ii) follow-up of the clinical course, (iii) generation of hiPSC~     lines (40 patients, 40 healthy controls), and (iv) quantitative assessment of hiPSC-EHT~     function under basal conditions and in response to pro-arrhythmic or cardio-active drugs and~     chronic afterload enhancement. The product of this study is an SOP-based assay with standard~     values for hiPSC-EHT function/stress responses from healthy volunteers and patients with~     different heart diseases. The project could change clinical practice and be a step towards~     individualized risk prediction and therapy of HF.~   "
48878|NCT02417298|"~     Pain associated with sickle cell disease is a common emergency department visit. It is also~     frequently associated with a high emergency department recidivism rate for pain control and~     admissions to the hospital. Opiates are considered the first line therapy for acute flares~     and to manage chronic pain. This often times leads to a stigma of being opiate seekers or~     frequent fliers. With this study, we wish to explore whether adding ketamine to standard~     acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates~     while improving the patient's perception of pain. In addition, we will be exploring whether~     ketamine as an adjuvant therapy can help reduce hospital admissions for the management of~     acute sickle cell crisis pain.~   "
48879|NCT02417285|"~     CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and~     expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of~     CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary~     efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory~     objectives. In the dose escalation part, the safety and tolerability of increasing doses of~     CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the~     maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a~     CC-122 dose selected from the escalation part of the study in combination with fixed dose~     obinutuzumab to further study safety and efficacy.~   "
48880|NCT02417272|"~     Background : Cervical degenerative disc disease is frequent and the consequence of aging.~     Degeneration may lead to disc herniation. Surgery is indicated in the presence of root~     compression with cervicobrachial neuralgia and/or myelopathy.~      Purpose: The main objective of the study is the comparison of efficacy between total disc~     replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical~     treatment of symptomatic cervical degenerative disc disease in term of Success rate,~     defined as preservation of adjacent segments, 24 months after surgery.~      In our knowledge, there are no published data about randomized clinical trials comparing~     these radiological parameters (worsening of degeneration signs on static cervical spine~     radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery,~     between these 2 surgical approaches in patients suffering from cervical degenerative disc~     disease.~   "
48881|NCT02417259|"~     We are conducting a prospective cohort study of 20 children with cyanotic congenital heart~     disease who are admitted for cardiac surgery. We will record cerebral and somatic near~     infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien~     INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively~     (baseline) and continue until 48hours post-operatively. We will also take measurements prior~     to discharge from hospital. Baseline demographics, physiological and laboratory variables~     will be recorded. Clinical outcome variables including mortality, duration of intensive care~     unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance~     will also be recorded.~   "
48882|NCT02417246|"~     Recently, the quality of generic metoprolol extended-release (ER) (Toprol XL,~     Activas,Wockhardt) products has been called into question with reports of inconsistent~     effects when switching from the brand name product to a generic formulation. Problems with~     how the body processes these drugs could have serious and widespread consequences given the~     high frequency of metoprolol ER use in the management of various cardiovascular disorders,~     including high blood pressure, coronary heart disease, heart failure, and cardiac~     arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead~     to variability in the way the body breaks down the drug (pharmacokinetics) and clinical~     response to generic versus name brand metoprolol ER formulation. Investigators will study~     the brand name and generic metoprolol ER formulations in subjects with high blood pressure~     to compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses~     of each product.~      The study objective is to provide information on how the body breaks down generic and brand~     name metoprolol ER products (pharmacokinetics) and how the body responds to generic and~     brand name metoprolol ER products (pharmacodynamics) to better understand if generic~     metoprolol ER products are as good as the brand name product.~   "
48883|NCT02417233|"~     This study will evaluate the efficacy of two strategies for enhancing overall preventive~     behaviors, retention in HIV care, and adherence to medication for HIV positive individuals~     in South Africa: SMS text messing and peer navigation services.~   "
48884|NCT02417220|"~     The purpose of this study is to conduct a randomized controlled trial to compare the weight~     losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015~     plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015~     Enhanced), over a 6-month period.~   "
48885|NCT02417207|"~     The purpose of this study is to observe a new scheme can achieve is the same as the~     traditional scheme of the effect of preventing hepatitis B recurrence.~   "
48886|NCT02417194|"~     The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC)~     outcome remains controversial. Thus, the investigators aim to examine the association of~     preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy.~     The investigators will prospectively collect the relevant data including preoperative HbA1c~     in 238 patients of RCC patients undergoing nephrectomy. The associations between clinical~     variables and risk of adverse pathological features and disease recurrence will be tested~     using a multivariate logistic regression and multiple Cox-proportional hazards model,~     respectively.~   "
48887|NCT02417181|"~     The aim of this study is to explore the effect of substituting General Practitioners (GPs)~     by Physician Assistants (PAs) in out-of-hours primary care. Effects are measured in terms of~     the implication for the care model, quality of care delivered by PAs in comparison to GPs;~     the complaints treated by PAs in comparison to GPs; safety, efficiency and patient~     satisfaction. Lastly, this study will provide insight in the changes in costs of healthcare.~   "
48933|NCT02416583|"~     To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor~     induction for nulliparas at term with an unfavorable cervix~   "
48934|NCT02416570|"~     This study aims to identify if clarithromycin (CLM) has potential as a widely available and~     inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell~     lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive~     a placebo.~   "
48888|NCT02417168|"~     Fevers raise the concern for serious bacterial infections in pediatric oncology patients~     receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of~     the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there~     can be a false negative result.~      Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to~     identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in~     differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology~     patients. A reliable predictor of bacteremia infections in pediatric oncology patients~     should decrease hospitalizations for fever and unnecessary antibiotic treatment.~      In our study we will measure procalcitonin levels in pediatric oncology patients presenting~     with fever. We will measure procalcitonin at the time of admission which is part of our~     standard of care for febrile pediatric oncology admissions. For the purpose of our study, we~     will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission.~     We will examine procalcitonin levels at these three timepoints to determine if elevated~     procalcitonin levels predict bacteremia in pediatric oncology patients with and without~     neutropenia.~   "
48889|NCT02417155|"~     Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative~     non-pharmacological therapies aimed at limiting cytokine production are highly warranted.~     Adrenaline, a neurotransmitter of the autonomic sympathetic nervous system, attenuates~     cytokine production. Along these lines, endogenous modulation of sympathetic activity could~     limit inflammation and therefore represent a treatment modality that would empower RA~     patients to exert self-control over disease activity. However, both the autonomic nervous~     system and the inflammatory response are regarded as systems that cannot be voluntarily~     influenced. Nevertheless, results from two recent studies demonstrate that this is possible~     through techniques developed by 'iceman' Wim Hof, namely meditation, exposure to cold, and~     breathing exercises. Hof himself and healthy volunteers trained by him were able to~     voluntarily activate the sympathetic nervous system, resulting in adrenaline release and~     subsequent suppression of the inflammatory response during experimental human endotoxemia (a~     model of systemic inflammation elicited by administration of lipopolysaccharide [LPS] in~     healthy volunteers). Interestingly, while having been taught all three techniques, during~     the endotoxemia experiment the trained subjects (like Hof himself) predominantly practiced~     the breathing exercises consisting of two different techniques. A `hyper/hypoventilation`~     technique, characterized by cycles of hyperventilation followed by breath retention and a~     `strength ventilation` technique consisting of deep inhalations and exhalations followed by~     breath holding. These techniques resulted in intermittent hypoxia and cyclic shifts in~     acid-base balance. Based on these observations and previous studies, the investigators~     hypothesize that these breathing techniques account for the increased production of~     adrenaline and thus for the suppressed inflammatory response but it is unclear which of~     these two techniques is most important.~   "
48890|NCT02417142|"~     This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly~     injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine~     exenatide's effects on negative symptoms and cognition.~   "
48891|NCT02417129|"~     This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator~     trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in~     patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2~     of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4~     dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the~     End of Study (EOS) Visit at Week 30.~   "
48892|NCT02417116|"~     Millions of people suffer from dry eye disease, causing symptoms such as redness, burning,~     feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your~     eyes do not produce enough tears or produce poor quality tears. This can happen for a number~     of reasons, including aging, hormonal changes in women and side effects of diseases or~     medications.~      It is now possible to objectively measure the degree of dry eye disease by collecting a tiny~     sample of tears from the corner of the eye and then measuring the amount of salt in the~     tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear~     osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate~     this to other factors such as symptoms, topical and nutritional medication and dry eye~     treatment.~   "
48893|NCT02417103|"~     The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon~     Liraglutide on the lipid metabolism an inflammation in adipose tissue.~   "
48894|NCT02417090|"~     Metformin in widely used as the treatment of gestational diabetes. However, it is not known~     whether exposure to metformin in utero has late metabolic effects on the child.~      In this study the investigators investigate metabolism (oral glucose tolerance test,~     insulin, plasma lipoproteins, inflammation markers as well as body composition by DEXA (dual~     energy X-ray absorption) and MRI) in 9 year-old children whose mothers used either metformin~     of insulin during pregnancy.~   "
48895|NCT02417077|"~     This study will examine the perception of facial expressions among individuals with and~     without crow's feet lines.~   "
48896|NCT02417064|"~     The purpose of this study is to compare the efficacy and safety of switching~     treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to~     which they have not responded) to either intranasal esketamine plus a new oral~     antidepressant or switching to a new oral antidepressant plus intranasal placebo.~   "
48897|NCT02417051|"~     The goal of this project is to adapt and test the efficacy of the National Institute of~     Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program~     for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to~     improve resilience for stress reactions in active emergency responders. A total of 120~     participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a~     waitlist control condition. A three-month assessment period will be utilized to enable us to~     evaluate the effects of the intervention. Participants assigned to the waitlist condition~     will be offered the option to participant in the course following completion of the 3 month~     wait period. It is hypothesized that, participants attending the DWRT program, as compared~     to those in the waitlist condition, will show increased resilience at three months~     post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more~     positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and~     depression symptoms. It is predicted that participants attending the DWRT program, as~     compared to those in the waitlist condition, will demonstrate greater awareness of the~     mental health effects of disasters, including the symptoms of PTSD and depression. It is~     predicted that, participants attending the DWRT program, as compared to those in the~     waitlist condition, will endorse more positive attitudes towards mental health care,~     including willingness to seek treatment if needed.~   "
48898|NCT02417038|"~     Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are~     given.Pathophysiological respiratory depression -failure to respond to hypercapnia or~     hypoxia - is challenging to measure clinically.American Society of Anesthesiologist~     guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery~     (CD).~      Use of capnograph will enable us to assess breath-by-breathe respiration in a population~     receiving neuraxial opioids - potentially at risk for respiratory depression.~      Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a~     cohort following opioid neuraxial administration for CD.~   "
48899|NCT02417025|"~     The purpose of this study is to determine whether a scientifically validated treatment for~     Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered~     effectively to Veterans with Military Sexual Trauma (MST) related PTSD using~     videoconferencing technology, which allows a therapist and patient who are not in the same~     room as one another to communicate. The investigators are interested in learning if this~     form of mental health service delivery is an acceptable alternative to traditional~     face-to-face therapy delivered with the therapist in the same room as the patient. This~     study is being conducted at the Charleston VA Medical Center and surrounding Community-Based~     Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.~   "
48900|NCT02417012|"~     This study evaluates the effect of a lifestyle intervention maintenance of glycemic control~     while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The~     intervention group receives an intensive lifestyle intervention including exercise and diet~     lifestyle modifications. The reference group receives diabetes educational advice. Both~     groups will have their pharmacological treatment regulated across the study. The primary~     hypothesis is that lifestyle change is sufficient to maintain glycemic control while~     decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.~   "
48901|NCT02416999|"~     This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide~     for recurrent high-grade gliomas.~   "
48902|NCT02416986|"~     The goal of this study is to evaluate the effects of exposure to standard smoking~     environments on ability to resist smoking as measured with a Delay to Smoking Task. The~     results of this study will inform whether the Delay to Smoking Task is a sensitive measure~     for evaluating environment-provoked craving and smoking behavior.~   "
48903|NCT02416973|"~     To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to~     sham treatment in patients with persistent pain following lumbar surgery when treatment is~     administered twice daily over a 60 day period.~   "
48904|NCT02416960|"~     Infertility has been currently recognized as a disorder related to obesity. Among several~     metabolic changes associated with obesity, insulin resistance appears to be linked to~     hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved~     in energy balance regulation and are also associated with reproductive system regulation,~     but its relationship with infertility is scarce. The aim of this study is to determine the~     effect of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels,~     hormonal, metabolic and reproductive parameters in infertile overweight or obese women~     candidates to in vitro fertilization. The patients who meet the inclusion criteria and~     accept to participate in the study, will be allocated in one of the following groups:~     Hypocaloric Low Glycemic Index diet group; Hypocaloric Conventional diet group or Control~     group (maintenance of usual diet) and follow the study protocol for 12 week. Immediately~     after the end of the diet protocol, the patients will be submitted to the in vitro~     fertilization treatment.~   "
48905|NCT02416947|"~     This study is designed to study the dose response effect of continuous Soluble Corn Fiber~     (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using~     the 41Calcium methodology. To further understand the dose response effect of SCF bone~     biomarkers will be studied.~      Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent~     manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as~     bone biomarkers of resorption.~   "
48906|NCT02416934|"~     This prospective, randomized, double blind, controlled study evaluates the effect of~     perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.~   "
48907|NCT02416921|"~     The purpose of this research study is to evaluate the effect of a Facebook-delivered~     weight-gain prevention program versus a Facebook-delivered program with general women's~     health information.~   "
48908|NCT02416908|"~     Selinexor has shown single-agent activity in a current phase I study enrolling patients with~     relapsed/refractory AML with durable complete remissions (CR), complete remissions with~     incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD)~     observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were~     manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity~     in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen~     without significant non-hematologic toxicity. Given the established role of CLAG~     chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities,~     the investigators propose a phase I/II open label study of selinexor in combination with~     CLAG for the treatment of patients with relapsed/refractory AML.~   "
48909|NCT02416895|"~     The purpose of this study is to examine the relationship between Vitamin D status and~     immunity.~   "
48910|NCT02416882|"~     This study tests whether different physical activity patterns are linked an individual's~     genes.~   "
48911|NCT02416869|"~     The aim of this randomized double-blind cross over clinical trial is to investigate~     effectiveness of different routes of applications (intramuscular and submucous at the site~     of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and~     quality of life after lower third molar surgery.~   "
48912|NCT02416856|"~     The integrity of structural connectivity supporting cortical regions in the left brain~     hemisphere is hypothesized to enable treatment-induced naming recovery in persons with~     language difficulties after a stroke (aphasia). We will map whole brain connectivity (i.e.,~     the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1)~     and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be~     used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve~     as a guide for speech-language pathologists and neurologists when facing patient management~     decisions.~   "
48913|NCT02416843|"~     Overweight and obesity are major problems and their complications such as cardiovascular~     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is~     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in~     part by the expansion of adipose (fat) tissue.~      Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged~     that in addition to storing energy as fats; adipose tissue secretes and responds to various~     chemical messengers in the body that are related to metabolism and inflammation. After a~     meal has been consumed, changes in metabolic (and some inflammatory) markers are seen in the~     blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose~     tissue itself.~      The investigators therefore plan to investigate these changes in adipose tissue before and~     after a meal and compare them to changes occurring in the blood. They also plan to~     investigate whether these responses are different in people who are overweight compared to~     'normal' weight.~      Participants will include males aged between 35-55 years who fit the criteria for inclusion.~     After taking some preliminary measurements and monitoring of normal daily activities,~     participants will attend one day of Laboratory testing in the Physiology Laboratories at the~     University of Bath.~      By investigating differences in metabolism and inflammation in adipose tissue and the~     circulation it is hoped that more will be learnt about the development of diseases~     associated with being overweight and ultimately help to develop more effective methods for~     prevention and treatment.~   "
48914|NCT02416830|"~     The purpose of this cohort post market registry is to collect data and create a global~     database on use of embolization devices and embolization procedures outcome. The data~     collected in the cohort will serve a scientific purpose to acquire better insight in~     embolization procedures. This will be achieved by publications in Scientific Journals and by~     presentations at scientific meetings. Additionally it will support the industry on creating~     a better overview of the products used to maintain and enhance the clinical efficacy of the~     used devices. The cohort post market registry represents a novel approach in a way of~     allowing Clinicians to generate reports based on an evolving controlled and well organized~     database~   "
48915|NCT02416817|"~     The purpose of this study is to compare two already validated methods for massive~     transfusion in trauma patients admitted to the emergency room of a large reference hospital.~   "
48916|NCT02416804|"~     Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine~     transdermal system (MTDS) among the patients with lumbar spinal disease who was performed~     the single-level posterior lumbar fusion.~      After surgery, all the patients apply the patient-controlled analgesia. After three days of~     surgery, patients are divided into two groups.Group A is an experimental group that~     administer the BTDS after surgery, and Group B is a control group that take tramadol~     analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional~     rescue medicine, acetaminophen.~      After the surgery, patient's pain score and quality of life would be recorded sequentially.~     The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3~     months, respectively.~   "
48917|NCT02416791|"~     Stroke is the second cause of death worldwide and represented the first cause of death in~     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop~     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.~     This study addresses this important issue, by combining two different interventions in the~     early phase post-stroke: robotic therapy associated or not with transcranial direct current~     stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor~     upper limb rehabilitation.~   "
48918|NCT02416778|"~     Disordered iron metabolism characterizes an important determinant of impaired exercise~     tolerance and work capacity. Iron-deficiency anemia commonly features impaired aerobic~     capacity caused by decreased oxygen carrying capacity, and has been associated with a~     negative effect on dyspnea and walking distance.~      Apart from that, iron deficiency without anemia was shown to affect endurance and energetic~     efficiency via decreased tissue oxidative capacity. Consequently, depleted iron stores could~     be capable of causing fatigue, breathlessness and impaired exercise tolerance, which are~     common features of chronic cardiopulmonary diseases like chronic heart failure (CHF) and~     COPD (Chronic Obstructive Pulmonary Disease). Indeed, a current surge of interest aimed at~     potential underlying determinants in CHF and COPD independent of the primarily disordered~     organ.~      Recent studies identified iron deficiency without anemia as an independent factor of reduced~     exercise intolerance in CHF as well as in COPD. Moreover, intravenous iron application~     significantly improved exercise capacity in CHF patients with iron deficiency in presence as~     well as in absence of anemia. Comparable to CHF, the daily living of patients with COPD is~     compromised by impaired exercise tolerance.~      However, airflow limitation, as the foremost characteristic of COPD shows only weak~     associations with exercise capacity. In line with that, exercise capacity showed no~     remarkable improvement in lung transplant recipients, underlining the presence of systemic~     determinants of limited exercise tolerance like iron deficiency. The investigators showed~     that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is~     according to recently published data.~      The investigators presume that iron deficiency contributes to limited exercise capacity in~     COPD patients. Thus, the aim of this study is to determine whether iv iron is associated~     with increases exercise capacity in COPD.~      Therefore the investigators hypothesize that filling up depleted iron storages will increase~     exercise capacity, measured by the 6-MWT (Minute Walking Test).~   "
48919|NCT02416765|"~     Postprandial meal glucose control with closed-loop systems (CLS) still needs some~     improvements. In the postprandial period, sensor delay in detecting blood glucose rise after~     a meal together with delays in insulin absorption expose patients to early risk of~     hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone~     CLS has the potential to improve post-meal control as compared to single-hormone CLS~     allowing a better glucose excursion related to a more aggressive insulin infusion while~     minimizing hypoglycemic risk. Several approaches have been tested for the determination of~     prandial boluses during closed-loop operation.~      The objective of this study is to test in outpatient unrestricted settings whether, in the~     context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to~     a simplified qualitative meal size estimation without a significant degradation in overall~     glycemic control in adult patients with type 1 diabetes.~      The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS~     with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean~     glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with~     full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with~     partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with~     partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented~     pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better~     than sensor-augmented pump therapy in terms of mean glucose.~   "
48920|NCT02416752|"~     Opioid tolerance in the perioperative period is inevitable especially with ultra-short~     acting agents such as remifentanil. Existing evidence had shown that opioid induced~     hyperalgesia due to neuroplastic changes in the central as well as peripheral nervous system~     leads to sensitization of pro-nociceptive pathways. However there has been a controversy of~     occurrence of such tolerance following the use of remifentanil and the quality of recovery~     as compared to conventional opioids. The investigators evaluated the occurrence of opioid~     tolerance and other significant adverse effects with remifentanil in subjects undergoing~     head and neck surgeries. The investigators studied ASA physical status I and II adult~     subjects undergoing elective head and neck procedures, under general anesthesia with minimum~     expected duration of 2 hours. The remifentanil infusion was used in one group and~     intermittent boluses of morphine or fentanyl administered in another group. They were~     evaluated for immediate post-operative pain by using numerical rating scale (NRS), the~     opioid consumption, post-operative nausea, vomiting, other significant adverse effects of~     remifentanil and the time to discharge from PACU.~   "
48921|NCT02416739|"~     Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate~     epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer~     cells. Nicotinamide was found to be effective in several animal cancer models including~     lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is~     also effective in the treatment of human lung cancer.~   "
48922|NCT02416726|"~     The objective of the study was to compare the gene mutation status among the primary tumor,~     matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small~     cell lung cancer (NSCLC) using next-generation sequencing (NGS).~   "
48923|NCT02416713|"~     Research participants will be recruited to take part in a randomized control trial.~     Participants' cellphone use will be observed during an initial baseline period. Participants~     will then be randomly assigned to one of four conditions: education only (control), opt-in~     blocking, opt-out blocking, and opt-out blocking with parental notification.~   "
48924|NCT02416700|"~     The main objective of this prospective, controlled, and randomized clinical study is to~     evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded~     implants with a single prosthesis. A split-mouth experimental design will be used, and the~     success rate of the installed implants will be determined. Twelve selected patients~     (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental~     implants. The protocol for preparing the surgical sites will be based on the manufacturer's~     recommendations and bone density. Patients with an initial torque less than 30 N·cm and an~     implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes,~     indicating which site is the test site, will be opened after the implants are installed.~     Transfer impressions of the implants receiving immediate loading will be produced so that~     temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after~     the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal~     adjustment will be made to ensure minimal contact at maximum intercuspation and absence of~     contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of~     implant installation) and 3, 6, 9, and 12 months after implant installation, the following~     aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell~     ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility~     of the implant, crestal bone loss around the implant (as determined by x-ray evaluation),~     probing depth around the implant, and periodontal pain.~   "
48925|NCT02416687|"~     The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy~     recurrence, especially in vulnerable populations. A limitation to recommending this practice~     universally is the low quality of evidence on the effect of the ENG implant on breastfeeding~     when inserted immediately postpartum. This study is the first assessing the impact of~     inserting the ENG implant immediately postpartum on the amount of milk using the gold~     standard method for this purpose.~   "
48926|NCT02416674|"~     Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a~     deceased human donor to a patient with a large abdominal wall defect. Abdominal wall~     transplantation is an innovative reconstructive procedure that has the potential to~     significantly improve the lives of patients with large abdominal wall defects. The purpose~     of this study is to develop the best practices for abdominal wall transplantation that will~     improve the outcomes of future abdominal wall transplant recipients.~   "
48927|NCT02416661|"~     This study should demonstrate the correlation and predictive value of lyso-Gb1 concentration~     with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during~     the study ERT/SRT-newly started Gaucher type 1 patients~   "
48928|NCT02416648|"~     The purpose of this study was to determine the effectiveness of a clinician client centered~     counseling on knowledge on HIV transmission and prevention, attitudes towards HIV/AIDS, and~     sexual behaviors of adult HIV patients enrolled in care in Yola, Nigeria.~   "
48929|NCT02416635|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     liver cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
48930|NCT02416622|"~     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus~     vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis.~     Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose~     escalation format.~   "
48931|NCT02416609|"~     Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect~     of a chemotherapy regimen with Gemcitabine and Oxaliplatin administered sequentially with~     stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined~     treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).~   "
48937|NCT02416531|"~     Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can~     cause intense itching as well stenosis, hindering the evacuation and urination. It can also~     limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual~     intercourse). The standard treatment for this disease is the use of topical corticosteroids~     to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic~     therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent~     and low-level laser therapy (LLLT) are therapies that can promote effective immunomodulatory~     responses at the application site by means of photophysical and photochemical phenomena from~     the molecular to the systemic level, which promote their use in chronic dermatoses. The aim~     is to study and compare the effects of PDT, LLLT, and topical corticosteroid in VLS~     evaluating clinical, histological, immunohistochemical and spectroscopic responses. The~     study will be prospective, randomized, and controlled, in a population of 60 women with~     histological diagnoses of VLS, enrolled on the outpatient clinic of Genitoscopy Department~     of the Pérola Byington Hospital in São Paulo. There will be 3 treatments groups: PDT, LLLT~     and topical corticosteroid, where will be allocated by randomization 20 patients in each~     one. The clinical course will be monitored by measuring local temperature, itching, clamping~     (atrophy), and the appearance of the lesion. Histologically, the slides will be classified~     according to the Hewitt grading and will have the ordering of collagen fibers quantified.~     Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1,~     p53 and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance.~     Descriptive and inferential statistical analyses will be conducted to compare the groups and~     for associations between different responses.~   "
48938|NCT02416518|"~     Genetic Exploration of the Molecular Basis of Malignancy in Adults.~   "
48939|NCT02416505|"~     This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control~     Trial.~      In this study, the investigators aim to evaluate the impact of a visual aid on patient~     comprehension an orthopedic informed consent discussion in low socioeconomic populations.~      The primary outcome is patient comprehension measured by a Validated Knowledge-Based~     Multiple Choice Questionnaire.~      The secondary outcomes include: Patient satisfaction and Time efficiency.~      The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic~     informed consent discussion will improve patient comprehension, satisfaction and~     time-efficiency of orthopedic care.~   "
48940|NCT02416492|"~     The primary purpose of the clinical study is to evaluate the clinical efficacy of~     intracranial administration of SB623 cells on patients with chronic motor deficit from~     Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of~     intracranial administration of SB623 cells on disability parameters and 2) to evaluate the~     safety and tolerability of intracranial administration of SB623 cells. Patients with stable,~     chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.~   "
48941|NCT02416479|"~     With kidney transplant (KT) recipients as our exemplar population, our goal is to develop~     and test interventions that increase medication adherence (MA) in chronically ill adults.~     Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the~     leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming~     one-third of KT patients experience MNA even though the problem is preventable. Adherence~     intervention studies have proven marginally effective for those with acute and chronic~     illnesses and ineffective for adult KT recipients. Using a randomized controlled trial~     design with an attention-control group, this R01 will test an innovative 6-month~     SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT~     recipients. This intervention shows great promise for increasing MA with a large effect size~     of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to~     systematically improve MA behaviors by identifying and shaping routines, involving~     supportive others in routines, and using medication taking feedback through small~     patient-lead experiments to change and maintain behavior. The Medication Event Monitoring~     System cap, which contains microelectronics that record the date and time of the cap~     removal, will be used to measure MA. Persistence of the MA behavior change will be examined~     by evaluating the difference in MA between the two groups during the 6-month maintenance~     phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and~     a cost-effectiveness analysis will be conducted.~   "
48942|NCT02416466|"~     This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions~     and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.~   "
48943|NCT02416453|"~     The purpose of this study is to evaluate the safety and tolerability of 3 vaccination~     schedules of Ad26.ZEBOV and MVA-BN-Filo administered IM as heterologous prime-boost~     regimens.~   "
48944|NCT02416440|"~     Type 2 diabetes (T2D) is an emerging epidemic in sub-Saharan Africa, with an estimated~     prevalence of 6%. With around seven million cases of T2D in 2000, it is anticipated that~     over 18 million Africans will have the disease by 2030. In South Africa the prevalence of~     T2D in people of African descent has been reported to be between 3-10%. However, there have~     been limited studies on diabetes epidemiology in South Africans using currently employed~     World Health Organization (WHO) criteria.~      To assess the burden of T2D and associated risk factors in South Africa, we are establishing~     the Durban Diabetes Study (DDS) - a population-based cross-sectional study in the city of~     Durban (the eThekwini municipality) to be undertaken in 1,200 participants of African~     descent. In-depth health questionnaire responses, biophysical measurements and blood and~     urine samples will be gathered from these participants. These data will allow researchers to~     estimate the population prevalence of T2D and associated risk factors in the region. The~     infrastructure created for this cross sectional study has the potential to serve as a strong~     framework for future research initiatives and public health interventions within the region.~   "
48945|NCT02416427|"~     This pre-surgical, window-of-opportunity study is designed to investigate whether~     atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer~     TAZ.~   "
48946|NCT02416414|"~     To compare the performance of the QuantiFERON Monitor assay against existing methodology.~   "
48947|NCT02416401|"~     Healthy aging is associated with a decline in multiple cognitive domains, as well as motor~     control function. The long-term consequences of cognitive and functional impairment~     resulting from age-related cognitive decline are well documented in the scientific and~     clinical literature, with significant evidence of related problems with independent~     functional abilities. This study aims to understand how the experimental computer program~     can affect cognition and attention in participants with age-related cognitive decline.~   "
49326|NCT02411474|"~     Investigate the profiles of tear cytokines in patients who underwent stem cell~     transplantation (SCT) and attempted to determine the applicability of tear cytokines in the~     diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers~     of chronic ocular GVHD severity.~   "
48948|NCT02416388|"~     This open label, multicenter phase III study with multiple randomization phases at~     differents stages of AML treatment (induction, consolidation and HSCT where applicable) is~     designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted~     patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis~     following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity~     (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial~     can test up to 3 molecules if new AML agents of interest were to come out in the near~     future.~   "
48949|NCT02416375|"~     The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a~     number of parameters on a daily basis at home which might predict respiratory infections~     before they have symptoms and which might also predict treatment failures before this is~     obvious with conventional measures.~   "
48950|NCT02416362|"~     The purpose of this study is to analyze the immediate effects of two exercise protocols on~     the vibration platform, on the strength of the thigh muscles, joint position sense of the~     knee and balance in healthy subjects.~   "
48951|NCT02416349|"~     The purpose of study is to evaluate the acute effects of respiratory muscles stretching on~     ventilator pattern and volume distribution of chest wall in patients with right hemiparesis~     post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the~     respiratory function.~   "
48952|NCT02416336|"~     The aim of this study is to investigate whether the Sentinella camera improves~     intraoperative detection and removal of sentinel lymph nodes (SLNs) when used in conjunction~     with standard detection methods. Of primary interest is whether the Sentinella camera~     identifies additional tumor-positive SLNs that are missed using traditional imaging~     techniques. Other outcomes related to the standard of care use of the Sentinella camera may~     also be assessed.~   "
48953|NCT02416323|"~     The purpose of this study is to test the effectiveness of training community mental health~     therapists to deliver a mental health intervention for ASD (AIM HI) and study the process~     of implementing AIM HI in community mental health programs.~   "
48954|NCT02416310|"~     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS)~     during perioperative could alleviate the postoperative gastrointestinal complications after~     cesarean section under combined spinal epidural anesthesia compared with control and~     non-acupoint group.~   "
48955|NCT02416297|"~     The purpose of this research study is to assess the clinical effectiveness of a minimally~     invasive alveolar microperforation procedure to achieve accelerated tooth movement in~     patients undergoing orthodontic treatment for orthognathic surgery. Accelerated tooth~     movement means that Microperforation technique may help complete orthodontic treatment~     sooner than would be expected in conventional orthodontic treatment~   "
48956|NCT02416284|"~     The Norwegian Directorate of Health recently published the Norwegian food-based dietary~     guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main~     aims of these guidelines are to promote public health and prevent chronic degenerative~     diseases. Reaching the healthy population is crucial as only small proportion of the general~     population comply to the current public dietary advice in Norway. Thus, the objective of~     this study is to investigate whether a multi-faceted dietary intervention could increase~     compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy~     population.~   "
48957|NCT02416271|"~     The main purpose of this study is to evaluate the effects of teriparatide with those of~     alendronate on spine bone mineral density (BMD) and other osteoporosis factors in~     postmenopausal women with osteoporosis.~   "
48958|NCT02416258|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray~     compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol~     spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.~   "
48959|NCT02416245|"~     The aim of the current study is to investigate the beneficial impact of 4 month consumption~     of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins~     and minerals on short term memory as assessed using standardised cognitive test battery.~   "
48960|NCT02416232|"~     This is a single arm open label, multicenter, non randomized, access study of trametinib for~     subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive~     mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV).~     Trametinib may be given as monotherapy or in combination since first line metastatic~     melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be~     included if they have not progressed under such treatment or if they have presented limited~     progression as per eligibility criteria. It is estimated that between 250 and 400 subjects~     with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that~     is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be~     enrolled.~   "
48961|NCT02416219|"~     Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric~     patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to~     prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different~     disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients~     by anatomical landmark palpation.~   "
48962|NCT02416206|"~     High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the~     up-front treatment of patients with multiple myeloma has been associated with improved~     disease-free and overall survival in multiple large randomized controlled trials. Following~     3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose~     Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to~     70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the~     standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical~     studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have~     yielded similar results to single-agent Melphalan with higher toxicity.~   "
49038|NCT02415218|"~     The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal~     epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for~     which no effective approaches has thus far been available, for the purpose of establishing~     this therapy as an effective strategy for this disease with an aim of improving visual~     acuity and corneal transparency.~   "
48963|NCT02416193|"~     Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to~     2.5 times higher in persons with diabetes than the general population. There is evidence~     that cognitive decline significantly impacts the ability to self-manage diabetes. Strategies~     to prevent cognitive decline in persons with diabetes has not been well studied. A recent~     study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia~     and Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of~     vitamin D has been reported to negatively affect the development of brain. Therefore,~     providing vitamin D supplementation to improve cognitive function is worthy of study. The~     investigators propose a small, randomized controlled trial to determine the effects of~     vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive~     impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation~     (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study~     aims are to determine (1) the effect of vitamin D3 supplementation on cognitive function and~     (2) the effect of vitamin D3 supplementation on diabetes self-management. A sample of~     persons with type 2 diabetes (n=62), who have a subjective complaint of a cognitive~     dysfunction or scoring at least one standard deviation below normal on a cognitive~     functioning screening test, have vitamin D levels less 30 ng/ml, are not depressed (as this~     impacts cognitive function), and do not have severe diabetes complication will be recruited.~     Participants will be phone screened and complete two baseline visits prior to randomization.~     They will then have phone call and follow-up visits to assess (1) cognitive function using~     standardized tests to assess for executive function (2) serum measurements (HBA1c, fasting~     glucose, vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive~     function as well as self-management behaviors.~   "
48964|NCT02416180|"~     This study aims to explore the potential impact of switching inhalers by assessing the~     handling error rate (critical and non-critical) in controlled asthmatics currently treated~     with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving~     SERETIDE via the Metered Dose Inhaler (MDI) (EVOHALER) without training by a Healthcare~     Professional (HCP).~      This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing~     MDI technique in subjects with controlled asthma (Asthma Control Test [ACT] score >= 20 at~     Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler.~     All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI.~     Subjects will need to use the MDI inhaler in accordance the accompanying patient information~     leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or~     comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be~     assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert~     back to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up~     by telephone for approximately 1 week after Visit 2.~      A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects~     complete the study. The total duration of the study for each subject will be approximately~     21 days.~      SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group~     of companies~   "
48965|NCT02416167|"~     The purpose of this study is confirmatory investigation of safety and efficacy (dose~     response and optimal dose according to the percent reduction from baseline in serum urate~     level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and~     without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance~     period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled,~     double-blind, parallel group comparison.~   "
48966|NCT02416154|"~     The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female~     genital tract, which has never been mapped before in humans. High expression in other~     mammalian female reproductive tract (FRT) has been suggested to be important in~     anti-sexually transmitted infection (STI)/HIV immunity and its expression decreases with~     progestogen treatment. Future studies are planned to understand if hormonal contraceptives~     affect the presence of interferon in the healthy female genital tract, potentially changing~     the risk of for STI and HIV.~   "
48967|NCT02416141|"~     If a termination of pregnancy procedure is performed by vacuum aspiration our patients~     receive a paracervical block. Nevertheless these patients are not free of pain. We~     randomised our patients: one group will receive additional orodispersible tramadol, the~     other group will receive a placebo.~   "
48968|NCT02416128|"~     The investigators plan to use an herbal eye drop, Euphrasia, aka Eyebright, for~     post-operative inflammation for Peripheral Laser Iridotomy for the treatment of narrow angle~     glaucoma. A peripheral Laser Iridotomy is a simple laser procedure with few complications if~     the patient follows the post-operative instructions. In this procedure, a blue-green Argon~     laser is used to create an orifice in the iris to open the angle by allowing the aqueous~     from behind the iris to enter the anterior chamber. Rarely the procedure needs to be~     repeated. The main complications from this surgery are postoperative inflammation, bleeding,~     and postoperative pressure spikes.~      The investigators will be using Weleda's Euphrasia D3 eye drops. The investigators plan to~     do a double blinded randomized control trial to objectively measure ocular inflammation in~     the same process that was used for the steroid eye drops that are currently out on the~     market. Some patients will be receiving steroids, prednisolone acetate, others, the herbal~     eye drop.~   "
48969|NCT02416115|"~     Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after~     general anesthesia, and may lead to increased hospital stay and health care costs. The risk~     factors for PONV include sex (female population), nonsmoking status, past history of motion~     sickness and/or previous PONV, duration of anesthesia and surgical type (particular~     gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has~     been reported to be 30% with considerable variability, but can increase up to 69%- 80% in~     women undergoing gynecologic surgery with general anesthesia and morphine-patient controlled~     analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first~     line therapies for preventing PONV because of their efficacy and few side effects compared~     with other antiemetics. However, despite the use of this treatment, the incidence of PONV~     has been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects~     of opioid. It was found that administration of low dose naloxone prevents opioid side~     effects such as nausea and pruritus without affecting analgesia or opioid requirements in~     patient receiving morphine PCA. It was reported that the use of two antiemetic acting at~     different mechanisms is better to prevent PONV than monotherapy.~      Therefore, this prospective, randomized, controlled study was designed to investigate the~     antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine~     PCA after gynecologic surgery.~   "
49039|NCT02415205|"~     The study will measure the effects of eye exams on markers of stress in the urine. In~     addition, measurements will be taken to show the effects of stress on brain activity, O2~     sats, and blood flow.~   "
48970|NCT02416102|"~     This is a proof of concept, open label protocol to evaluate the effect of losartan on~     cigarette smoke-induced lung injury in smokers, ex-smokers with and without chronic~     obstructive pulmonary disease (COPD), giving 50 mg and subsequently 100 mg losartan for 4~     weeks~      Aim: To test that inhibition of T-cell growth factor (TGF-ß) with losartan in ex-smokers~     with COPD and active and passive smokers without COPD will lead to an increase chloride~     conductance through calcium-activated chloride channel (CACC), as measured by nasal~     potential difference (NPD).~      Study design: The Investigators will assess the consequences of active and passive smoking~     and the treatment with losartan on CaCC-mediated chloride conductance in human beings using~     NPD measurements.~      NPD is a direct measure of ion transport. It measures CaCC-mediated Cl- secretion and thus~     serves as an indirect measure of voltage-dependent potassium (BK) channels function. In~     addition, improvement of NPD measured ion transport was indirectly linked to lung function~     improvements and clearance in trials with cystic fibrosis patients. Therefore, NPD lends~     itself as a good surrogate for Mucociliary clearance (MCC), in a proof of concept clinical~     trial.~      The investigators will also measure TGF-ß levels in nasal secretions and cells to correlate~     these with the level of CaCC-mediated Cl- conductance.~   "
48971|NCT02416089|"~     The purpose of the study is to evaluate the safety, feasibility and applicability of a new~     device 'Tampostat' in the management of primary postpartum hemorrhage and compare the~     efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional~     condom catheter.~   "
48972|NCT02416076|"~     Up to 40 subjects will be enrolled, randomized and treated. Enrolled subjects will receive~     one, split-face Ulthera® treatment on the face and neck using a standard transducer on one~     side of the face and a simulines transducers on the other side of the face. Follow-up visits~     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,~     immediately post-treatment, and at each follow-up visit.~   "
48973|NCT02416063|"~     The aim of this prospective randomized double-blind study was to compare the analgesic~     efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with~     bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical~     surgery.~   "
48974|NCT02416050|"~     Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three~     month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated~     with relapse to cocaine use.~   "
48975|NCT02416037|"~     Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using~     PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration,~     prevention of opening and closing of terminal respiratory units at minimal hemodynamic~     compromise. The challenge is to carry out these objectives in a patient-centered approach~     based on individual characteristic of lung pathophysiology. Recently, it has been proposed~     to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp)~     is obtained from the difference between airway pressure and measured esophageal pressure~     (Pes). Measured Pes values have been found positive in the supine position in ARDS patients,~     leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to~     adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival~     is under investigation. Prone position ventilation significantly improves survival in severe~     ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.~      The purpose of present project is to investigate Ptp at end-expiration in the prone position~     in severe ARDS. The project is centered on the question about what are the values of~     measured Pes in prone position. The hypothesis is that they are lower than in the supine~     position due to the relief of the weight of heart, mediastinum and lung and also to~     recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp,~     end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional~     recruitment by using electrical impedance tomography. will be assessed in supine then in the~     prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor~     proposal.~   "
48976|NCT02416024|"~     Induction of general anesthesia to the patient could be a challenging period of anesthesia~     management. Due to autonomic system suppression, hemodynamic fluctuation, such as~     hypotension or hypertension, is commonly seen during this period. Furthermore, it has been~     observed that a fraction of patients who develop hypotension may be refractory to vasoactive~     medications to attempt to restore the systemic arterial blood pressure back to an acceptable~     level.~      Previous studies have shown that patients chronically taking angiotensin converting enzyme~     (ACE) inhibitors have a higher incidence of developing hypotension under general anesthesia~     as well as being refractory to adrenergic vasoconstrictor medications given to help restore~     systemic blood pressure. Interestingly, not all patients taking ACE inhibitors have shown~     the described hemodynamic response after induction of general anesthesia. Therefore,~     investigators are attempting to identify what changes in vascular physiology in those~     patients may contribute to acute refractory systemic hypotension. Specifically,~     investigators wish to explore whether differences in baseline levels of arterial stiffness~     potentially contribute to this phenomenon. Arterial applanation tonometry is a non-invasive~     technique that has been shown to reliably provide indices of arterial stiffness. In the~     proposed project, applanation tonometry will be performed on the right carotid and femoral~     arteries to assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness.~     (SphygmoCor system, AtCor Medical, Sydney, Australia) The measurement will be obtained~     before induction of general anesthesia in the pre-surgical area. During induction of general~     anesthesia with standard induction agents, brachial blood pressure will be measured by a~     cuff every minute up to 10 minutes after tracheal intubation. A hypotensive response to~     anesthesia will be defined by a systolic arterial blood pressure below 90mmHg upon~     induction. Hypotensive patients that do not respond to vasoconstrictor medications (i.e.~     requires more than 200 mcg phenylephrine to maintain systolic arterial blood pressure above~     90 mmHg) will be classified as 'refractory hypotensive. Using non-invasive applanation~     tonometry, we will be able to examine if aortic stiffness has a propensity to become~     refractory hypotension after induction of general anesthesia. This information will~     potentially help identify future patients that might be at greater risk of developing~     refractory hypotension in response to induction of general anesthesia.~   "
48977|NCT02416011|"~     The purpose of this study is to develop and test a series of booklets designed to assist~     smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting~     smoking and remaining smoke-free.~   "
48978|NCT02415998|"~     The aim of this study is to assess whether transesophageal echocardiography (TEE) can be~     used to successfully guide an epidural catheter to a targeted thoracic level in pediatric~     patients. The catheter will be placed in the epidural space under real-time TEE imaging and~     assistance by a trained TEE operator (this could include an anesthesiologist or~     cardiologist).~   "
48979|NCT02415985|"~     To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg~     thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients~   "
48980|NCT02415972|"~     Stroke, a personal, familial, and social disaster, is the first cause of acquired~     disability, the second cause of dementia, and the third cause of death worldwide. Its~     associated socio-economic costs are astronomic. The burden of stroke is likely to increase,~     given the aging of the population and the growing incidence of many vascular risk factors.~     Therefore, apart from further development of stroke prevention and treatment strategies,~     rational and effective tools for diagnosis, monitoring, and follow-up for stroke patients~     have potential high long-term clinical and economic consequences.~      For neuroradiological work-up, computed tomography (CT) or magnetic resonance imaging (MRI)~     are used as gold standard techniques to detect presence or absence, effective state, and~     extent of stroke. However, these techniques achieve simply a baseline study of ischemia~     occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, their~     rapid and actual availability, especially in primary hospitals, and their dynamic~     capabilities and predictive values for further infarction are poor with critically ill~     patients have to be repeatedly transferred to the scanning unit for each measurement.~     Whereas CT examination is associated with x-ray radiation and may miss early detection of~     stroke, MRI is associated with higher costs and not generally routinely and around-the clock~     available in all the hospitals. Therefore, a simple, fast, repeatable, non-hazardous, and~     non-invasive dynamic bedside tool for the detection of acute brain tissue hypoperfusion and~     monitoring for potential further infarction or efficacy of thrombolysis either by systemic~     intravenous thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or by~     selective intraarterial fibrinolysis and mechanical recanalization, both combined with or~     without bridging after acute ischemic stroke, is strongly needed.~      A promising alternative method of diagnosing stroke represents contrast-enhanced ultrasound~     perfusion imaging (UPI). What makes UPI so valuable is the advantage of repeatedly and~     non-invasively detecting brain tissue at risk for infarction by dynamic direct brain tissue~     perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel~     diameter. Because of the possibility to screen and repeatedly measure the state of~     perfusion, the chances increase to diagnose and monitor ischemic stroke and to define the~     appropriate window for treatment. The perfusion analysis would also allow determination of~     treatment results and guidance of rapid and adequate further therapy.~      Therefore, the present pilot study in 40 patients is initiated. The objectives of this~     observational diagnostic cohort trial are to evaluate feasibility and practicability of~     repeated bedside assessments by contrast enhanced UPI in acute ischemic stroke patients and~     to assess whether UPI can detect alterations in brain tissue perfusion before and after~     recanalising therapy of strokes. Assessment of cerebral perfusion by CT or MRI serves as~     reference and its results are compared to UPI data.~   "
48981|NCT02415959|"~     The objective of this study is to assess the efficacy and safety of different doses of Creon~     Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant~     (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis~     (CF).~   "
48982|NCT02415946|"~     BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of~     edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants~     the possibility to place implants of desired length and diameter could be limited. lSFE and~     tSFE represent two surgical options to vertically enhance the available bone in the~     edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and~     long times needed for the finalization of the prosthetic rehabilitation, however, strongly~     limit the indications of lSFE and support the need for less traumatic procedures with~     similar clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a~     user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely~     the Smart Lift technique.~      AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift~     technique as a simplified and minimally-invasive procedure for the implant-supported~     rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.~      METHODS In a multicenter RCT study design, the reconstructive (clinical) and~     patient-centered outcomes of tSFE performed according to the Smart Lift technique will be~     compared with those of conventional lSFE.~      EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of~     treatment time, post-surgery complications and costs and an increase in the satisfaction~     perceived by the edentulous patient with implant-supported rehabilitation, while maintaining~     a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to~     lSFE. In other words, the investigators expect that more favorable risk-benefit and~     cost-utility ratio, as well as a better performance in terms of pain, comfort, physical,~     social and psychological effects of oral health, and issues concerning the OHRQoL, will be~     observed for the Smart Lift technique compared to lSFE.~      List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE:~     sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus~     floor elevation with transcrestal approach~   "
48983|NCT02415933|"~     This study tests the effects of family-based economic empowerment intervention, alone and in~     combination with child rights sensitization component, on child protective outcomes among~     ultra-poor families in Nord Region, Burkina Faso.~   "
48984|NCT02415920|"~     This study investigates whether oxytocin, a neuropeptide known for its role in social~     bonding, influences the outcomes of persuasive communications. Participants will be given~     either oxytocin or a placebo. Then, participants will view several videos discussing~     opinions that they agree and/or disagree with. Participants' physiological and psychological~     responses to the videos in the different conditions will be compared.~   "
48985|NCT02415907|"~     The purpose of this study is to investigating the absorption, metabolism and excretion of~     radio labelled single doses of idalopirdine in healthy men.~   "
48986|NCT02415894|"~     The goal of this study is to examine the effectiveness and feasibility of a~     mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in~     Ukraine.~   "
48987|NCT02415881|"~     Phase I trial to evaluate the safety of escalating dose levels of conjugated~     panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that~     undergo surgery with curative intent.~   "
48988|NCT02415868|"~     This purpose of this study is to collect vaginal microbial samples of postmenopausal women~     to assess the optimal conditions for cultivation and storage of the vaginal microbiota.~     These samples will subsequently be used to develop a high-throughput assay that mimicks the~     vaginal microbial community of postmenopausal women. This assay will be used to select and~     screen compounds that can affect the vaginal microbiota and subsequently affect related~     symptoms such as vaginal dryness.~   "
48989|NCT02415855|"~     Study Design:~      This is a multicentre, prospective, open-label, single arm, phase IV registry study. No~     additional procedures are included in the study. Standard clinical data will be collected.~     This will include a physical examination and NIHSS score assessment at baseline. In~     addition, all neuro-imaging will be collected. Standard imaging includes a non-contrast CT~     brain at baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of~     the 7 day CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will~     also be collected when performed as part of standard care.~      Study Objectives:~        1. Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in~          patients with atrial fibrillation.~        2. Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of~          dabigatran treatment following stroke/TIA~        3. Determine the effect of asymptomatic hemorrhagic transformation on functional and~          neurological outcome at 30 days.~   "
48990|NCT02415842|"~     The purpose of this exploratory, retrospective laboratory study is to assess the humoral~     immune response to H1 hemagglutinin stalk domain and other influenza A virus protein~     epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted~     and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously~     completed clinical trials.~   "
48991|NCT02415829|"~     The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX)~     in patients with local advanced colorectal cancer.~   "
48992|NCT02415816|"~     Children with sarcomas are routinely assessed with a variety of imaging techniques that~     involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone~     scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many~     imaging studies at the time of diagnosis, during therapy and for years following completion~     of therapy. Because children are in a stage of rapid growth, their tissues and organs are~     more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore,~     compared to adults, children have a longer life expectancy and, therefore, a longer period~     of time in which to develop the adverse sequelae of radiation exposure, such as the~     development of second malignancies.~      Alternative experimental methods of measuring tumor response will be compared to current~     standard of care measures to determine if the experimental method is equivalent to methods~     currently being used. Investigators wish to determine if they can reduce patient's exposure~     to the harmful effects of ionizing radiation by replacing imaging studies that use radiation~     with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use~     any radiation. They also want to know if DW-MRI measurements of the tumor can tell how well~     the tumor is responding to therapy. There have been studies in adults with cancer that have~     shown that DW-MRI provides useful information about how tumors are responding to therapy.~     There have only been very small studies of DW-MRI in children with tumors in the body.~     Therefore, the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still~     experimental. This study might give us important information that could help us treat other~     children with bone or soft tissue sarcomas in the future.~   "
49075|NCT02414737|"~     We would like to propose that it may be possible to use a solitary dose of Elonva~     (corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of~     women undergoing IVF, assuming that it is possible that coasting (withholding short acting~     rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a~     significant number of mature oocytes being produced and an acceptable pregnancy rate.~   "
48993|NCT02415803|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)~     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to~     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment~     elevation. These recommendations are primarily based on large, randomized, Phase III~     clinical trials. However, few East Asian patients (or those of East Asian descent) have been~     included in these trials to assess the use of these drugs. In addition, a growing body of~     data supported that East Asian might have different adverse event profiles (thrombophilia~     and bleeding) and therapeutic window compared with white subjects. Furthermore, East~     Asian paradox phenomenon has been described that East Asian patients have a higher~     prevalence of platelet reactivity during DAPT, but an ischaemic event rate following PCI or~     ACS is similar or even lower than white patients. Therefore, the antiplatelet treatment~     strategy that is most appropriate for East Asian patients is increasingly urgent. Therefore,~     we performed the current study to observe the different effects of low-dose ticagrelor (45~     mg twice daily), conventional-dose ticagrelor (90 mg twice daily) and clopidogrel (75mg once~     daily) on high platelet reactivity (HPR) and IPA, and investigated the safety and efficacy~     of low-dose ticagrelor further in Chinese patients with non-ST-elevation ACS (NSTE-ACS).~   "
48994|NCT02415790|"~     This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics~     (PK) of single oral ascending doses of E2027, will be administered to healthy adult~     participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic~     (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic~     guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a~     broad dose range, to establish the PK/PD relationship.~   "
48995|NCT02415777|"~     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy~     and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction~   "
48996|NCT02415764|"~     Our team will develop a prototype game (OnTrack>The Game) in which users play the role of a~     person who has experienced First Episode Psychosis and move through animated role-playing~     scenarios, learning practical tips for engaging in care, playing mini-games to develop self-~     advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game~     is designed in an engaging comic book style in which the player is presented with realistic~     situations designed to promote engagement and the development of trusting relationships.~      Following development of the prototype, the investigators will conduct a pilot study to~     develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness~     study. This pilot study aims to demonstrate proof of concept for OnTrack>The Game. The~     investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that~     offer services for those experiencing their first psychotic episode. Quantitative data will~     be collected through baseline and follow up surveys that utilize instruments to measure~     knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and~     sense of hopefulness. The investigators will also conduct semi-structured interviews with a~     subset of participants to explore engagement in treatment and attitudes toward the game.~   "
48997|NCT02415751|"~     This study is assessing the effects of a new heart failure self-care education program in~     the Nebraska Heart Institute Heart Improvement Clinic. The new education program will~     consist of an initial intensive self-care education session with the Principal Investigator~     or her nurse practitioner. Topics to be discussed include medications, sodium and fluid~     consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs~     and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on~     an annual basis as studies have shown that the impact of HF education is not always durable~     and must be a continual process. This study will assess the impact of this review on their~     medication knowledge, disease state knowledge, quality of life, disease state progression~     and clinical outcomes such as ejection fraction and number of hospitalizations.~   "
48998|NCT02415738|"~     Hypoxemia may be refractory to protective ventilation during the acute respiratory distress~     syndrome (ARDS), justifying the use of other therapies that improved oxygenation and~     decreased mortality, including prone position (PP).~      During ARDS, the majority of patients are responders to PP with increased PaO2 due to~     homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and~     intra-abdominal pressure, hemodynamic parameters are not changed.~      Besides the fact that the PP improves systemic oxygenation is it the same on cerebral~     oxygenation? No study has investigated the cerebral oxygenation during PP in patients with~     ARDS. The cerebral oxygenation may be altered due to the position of the patient and high~     levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for~     cognitive impairment when patients awake.~      NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information~     on cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for~     the management of resuscitation in Intensive Care Unit (ICU) patients. This study is to~     investigate cerebral oxygenation during prone position in the investigators' patients of~     ICU.~   "
48999|NCT02415725|"~     Many clinical situations in oncologic surgery imply the need to dissect more or less~     extensively lymph node stations which are in direct relation with the lymphatic drainage of~     the anatomical region affected by cancer.~      The dissected lymph nodes drain generally several regions, and their dissection reduces then~     the drainage capacity of all these regions, increasing the risk for the patient to develop a~     secondary lymphedema, shorter or longer after surgery.~      Efficient treatments exist, but are difficult to implement and to continue for a long~     time.The later the treatment of the lymphedema begins, the heavier it is, both on the~     medical and socio-economic level.~      The lymphofluoroscopy, shows that some oncologic patients, operated and free of apparent~     secondary lymphedema, present abnormalities of the lymphatic network.~      The present study aims to confirm that it is now possible to detect secondary lymphedema at~     a subclinical stage.~   "
49000|NCT02415712|"~     The objective of this survey is to evaluate the safety and efficacy of fomepizole~     intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in~     daily medical practice.~   "
49001|NCT02415699|"~     Stage III colorectal cancer constitutes more than half of the colorectal patients, and the~     prognosis does not improve much recently although varies of adjuvant drugs have been tried.~     DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in~     stage III colorectal cancer patients stains unclear. The investigators study will focus on~     the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment~     of stage III colorectal cancer, compared with chemotherapy alone.~   "
49002|NCT02415686|"~     SUMMARY~      Rationale:~      People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden~     Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium~     channel mutation (SCN1A) not only alters cortical excitability but also increases the~     propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced~     arrhythmias in human DS subjects.~      Objective:~      To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of~     cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.~      Study design:~      Observational study.~      Study population:~      Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥~     1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of~     self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the~     EEG databases of the participating centres. Only those controls with two or more recorded~     seizures will be matched to the cases.~      Intervention:~      Main study parameters/endpoints:~      Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising~     discomfort. If this nevertheless may occur, the study can be terminated. This study provides~     specific tools to investigate the seizure-related heart rate response. Subjects may thus~     benefit from participation by identification of otherwise unknown arrhythmias. The rationale~     of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of~     sudden death) specifically applies to DS, a rare epileptic syndrome including minors and~     incapacitated persons. The investigators believe that the lack of risks, the potential~     diagnostic benefit, the minimal intervention with novel and wearable sensors and the~     possibility to terminate the study in case of discomfort, justifies the study in this~     patient group.~   "
49003|NCT02415673|"~     The aim of the present study was to compare the effectiveness of two alignment sequences~     with thermal activated archwires with different Af temperatures applied for the correction~     of mandibular anterior crowding~   "
49004|NCT02415660|"~     This study will assess the short term response of thoracic spinal manipulation with or~     without trigger point dry needling in 58 subjects with a primary complaint of mechanical~     neck pain.~   "
49005|NCT02415647|"~     The purpose of this research is to study new ways of classifying mental disorders in~     children based on observable behavior and genetics to ultimately diagnose these disorders~     better.~   "
49006|NCT02415634|"~     The complexity of critical illness can result in both physical and psychological~     consequences for survivors, which can extend past the intensive unit care stay and after~     hospital discharge. A need for information and empowerment in the recovery process are~     highlighted for developing treatment strategies. It is suggested that there is a~     relationship between physical problems and psychological symptoms, but this has not been~     researched. This pilot study aims to test the effectiveness of a physiotherapy directed~     Rehabilitation after Critical illness Assisted discharge Pack (RECAP) on the physical and~     psychological function of patients recovering from critical illness in the first three weeks~     post discharge from ICU to the general ward area. The study will rely on a randomized~     controlled clinical trial design, with patients assigned to either a usual care control~     group vs. the treatment group. It is expected that engaging patients in their rehabilitation~     plan will focus physiotherapy treatment and improve physical recovery. It is hypothesized~     that the RECAP will reassure, support and empower patients to directly affect their~     psychological recovery in the first three weeks after critical illness.~   "
49007|NCT02415621|"~     Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA)~     to treat metastatic prostate cancer at 1000 mg daily.~      The purpose of this study is to find out if an on and off schedule of taking abiraterone~     would prolong the participant's cancer's response to this drug and maintain their~     functionality to perform their daily activities.~   "
49008|NCT02415608|"~     This phase II trial studies ibrutinib to see how well it works in treating patients with~     systemic (affecting the entire body) mastocytosis that has spread to other parts of the body~     and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis~     is a disease in which too many mast cells (a type of immune system cell) are found~     throughout the body. Mast cells give off chemicals such as histamine that can cause flushing~     (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low~     blood pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of~     the enzymes needed for cell growth.~   "
49009|NCT02415595|"~     The purpose of this study is to find at least one dose of BMS-955176 that will be safe,~     effective and tolerable for HIV-1 infected treatment naive adults.~   "
49010|NCT02415582|"~     The purpose of this study is to compare the effects of two exercise protocols on~     post-exercise blood pressure versus a control group in elderly hypertensive men.~     Participants are allocated to all groups: control group and two experimental exercise~     protocols, in a random order. In the control group, participants remain resting sitting,~     and, in the exercise protocols, participants practice exercise bouts of aerobic exercise or~     a combination of resistance and aerobic exercises. In order to standardize baseline~     conditions, before the sessions subjects remain sitting quietly for 20 minutes. After each~     exercise protocol, participants have 60 minutes for recovery and, simultaneously, they have~     BP measured every 5 minutes. After the exercise sessions or control, an equipment for 24~     hours ambulatory BP monitoring is installed in every participant.~   "
49011|NCT02415569|"~     The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful~     to improve bowel cleansing quality before colonoscopy.~   "
49012|NCT02415556|"~     The main purpose of this study is to find the long-term effects of daily administration of~     40 IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and~     memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks~     with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI;~     DM group treated with placebo; control group treated with INI and the control group treated~     with placebo. The INI or placebo will be delivered into the nose. The investigators are~     interested to see whether INI can improve memory and cognition and blood flow in the brain~     in the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term~     period.~   "
49013|NCT02415543|"~     This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total~     Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total~     Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve~     the surgical-related technical details and the device design.~      In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery~     item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the~     SIL-TEP technology in the investigators country.~   "
49014|NCT02415530|"~     This is randomized controlled trial investigating the effect of early intervention in very~     low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than~     control group of VLBW infants, study population includes term infants to compare~     neurodevelopmental outcome.~   "
49015|NCT02415517|"~     The daily routine in clinical settings often showed cognitive impairments in patients with~     congestive heart failure, particularly in terms of executive functions, episodic memory,~     perceptual speed and attention. It is assumed that cognitive impairments in patients with~     congestive heart failure may lead to deficits in medication-adherence and self-care~     abilities, resulting in increased healthcare costs. Recent studies reported performance~     improvements after cognitive training that transferred to new, untrained tasks and abilities~     in healthy subjects across a wide range of ages. This study investigates the effects of~     cognitive training in patients with congestive heart failure.~   "
49016|NCT02415504|"~     This pilot study examines the impact of an enhanced care transition process vs. usual care~     for persons with dementia admitted to a transitional unit (hospital or LTC) for management~     of behavioural and psychological symptoms of dementia (BPSD) with a planned discharge to~     long term care (LTC) facilities or other hospital units. Deficiencies in discharge processes~     can contribute to poor outcomes (e.g., readmissions), and there is a dearth of research on~     how to improve care transitions for persons with BPSD. The investigators aim to improve the~     care transition process for persons with dementia and BPSD utilizing an enhanced care~     transition process that will contain up to 6 elements: integrated behavioural care plans,~     videos, patient specific briefcase containing activities to reduce BPSD, in-person care~     transition meeting, in-person care demonstration (when possible), and follow up visits with~     a transition team. The ability to determine the effect of enhanced care transitions on the~     clinical course of patients with planned discharge to LTC or hospital may allow for improved~     outcomes and an overall increased efficiency of post discharge care.~   "
49017|NCT02415491|"~     Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the~     cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition~     of the great arteries.~   "
49018|NCT02415478|"~     For patients with emphysema, lung volume reduction by insertion of endobronchial valves~     could be an expedient approach to improve the diaphragm function and the strength of~     breathing muscles. Therefore in the present study investigators intend to examine, whether~     the lung volume reduction by valves might improve the physical capacity and the quality of~     life.~   "
49019|NCT02415465|"~     Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE)~     for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.~      Hypothesis: CACB will provide better mobility than CSE post operatively.~   "
49020|NCT02415452|"~     This study is to investigate the relationship between staging of retinal artery lesions and~     the prognosis of acute coronary syndrome (ACS) in a Chinese population. All the patients~     were divided into four groups according retinal artery lesions.The endpoints were main~     adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death,~     myocardial infarction (MI), and stroke after 3 to 6 years of follow-up.~   "
49021|NCT02415439|"~     The purpose of this study is to examine the safety, tolerability, and PK of various~     increasing single and multiple doses of VBP15 in healthy adult subjects.~   "
49022|NCT02415426|"~     The participants of this study have been diagnosed with mild to moderate depression with no~     evidence of suicidal actions prior to recruitment. All recruited subjects receive standard~     therapy and participate in a metacognitive training program (D-MKT) independently of study~     participation. Diagnostic and therapeutical interventions are not part of this study. As~     part of this study, the change of cognitive and psychosocial achievement/behavior in~     patients with mild to moderate depression after taking part in the training program is being~     investigated. The training program seeks to enable group members to recognize and correct~     the often automatic and unconscious thought patterns that accompany depression, in part by~     viewing this depressive thought process at a distance (i.e., depersonalizing). In addition,~     dysfunctional assumptions about one's thought processes, as well as dysfunctional~     coping-strategies (i.e., thought suppression, rumination as problem-solving) are targeted~     (Lena Jelinek & Steffen Moritz,~     http://clinical-neuropsychology.de/metacognitive_training_for_depression.html). Within this~     study the cognitive and psychosocial behaviour changes are being investigated by~     neuropsychological assessment as well as questionnaires.~   "
49023|NCT02415413|"~     Patients included in the study will receive induction treatment during 6 months, followed by~     receive high-dose therapy followed by peripheral blood stem cell transplantation.~      Approximately 3 months after peripheral blood stem cell transplantation patients will~     receive consolidation treatment during 2 months.~      Subsequently patients will start maintenance treatment during 24 months. Therefore, the~     total duration of the treatment will be approximately 36 months.~   "
49024|NCT02415400|"~     The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist~     given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial~     fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in~     the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors~     (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a~     comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K~     antagonist, such as warfarin, with or without aspirin.~   "
49168|NCT02413528|"~     The purpose of this study is to assess the use of a mobile health intervention to improve~     adherence to asthma medication among adolescents. The intervention consists of an inhaler~     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and~     incentivize patients to use their medication. This study will assess medication use~     throughout the study in patients who receive a mobile app with reminders and asthma control~     as measured by the ACT [asthma control test].~   "
49025|NCT02415387|"~     This randomized clinical trial uses a typhoid vaccine to cause an immune response in~     patients with stage I-IIIA breast cancer who received chemotherapy and studies whether~     patients' fitness levels affect how well their bodies handle a challenge to their immune~     system. A vaccine is a substance or group of substances meant to cause the immune system to~     respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may~     cause excess inflammation in the body and behavioral changes, such as depression, fatigue,~     pain, and problems with thinking and reasoning. Studying immune responses in patients with~     breast cancer who have undergone chemotherapy may help doctors learn whether physical~     fitness can protect the body from effects of immune system stress and whether it may be able~     to reduce health problems in patients with breast cancer who have undergone chemotherapy.~   "
49026|NCT02415374|"~     The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in~     oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of~     AVAs and their potential metabolites after ingestion. The blood and urine concentrations~     will be quantified at several different time points after the oat flour cookies are consumed~     to characterize the concentration-time profile.~   "
49027|NCT02415361|"~     In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents~     of infants with CLP need information and support, especially with feeding immediately after~     birth. These needs are often not met. The purpose of this study is to investigate the effect~     of systematic follow ups of parents with infants with CLP performed by a special trained~     nurse. Parental information needs, parental coping and stress and infant growth and feeding~     will be explored and compared to a control group receiving standard care. 26 parents~     (mothers and fathers) or more shall be included in each group according to specific~     criteria. The control should be examined first. Both groups will answer questionnaires 3~     times during the child's first year.~   "
49028|NCT02415348|"~     This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive,~     ultrasound-based device used to estimate fibrosis in patients with chronic liver disease,~     interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators.~     Recruitment consists of a total of 200 outpatients undergoing routine pacemaker~     interrogation at a teaching-hospital pacemaker clinic.~   "
49029|NCT02415335|"~     For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the~     incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration~     of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been~     established. The investigators wish to see if preoperative administration of 8 mg~     dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected~     appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the~     investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid~     consumption, postoperative fatigue, duration of time until resumption of work and resumption~     of normal daily activities, and enhanced the quality of recovery.~   "
49030|NCT02415322|"~     The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission~     rates of online and/or smartphone game addiction among elementary and secondary school~     students in Korea. In addition the investigators are going to identify risk and protective~     factors, to determine whether online and/or smart phone game addiction is a primary or~     secondary problem, and to identify outcomes for individuals who become or stop being online~     and smart phone game addiction.~   "
49031|NCT02415309|"~     Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated~     chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy~     suite. During this procedure, a physician inserts the needles to deliver local anesthetics~     such as lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many~     patients experience anxiety before and during the lumbar medial branch block procedure and~     require intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation~     requires one-to-one nursing care, monitoring, and recovery. In order to minimize the costs~     and time requirements of intravenous sedation, a suitable oral medication which is readily~     available and non-controlled would be ideal. Several randomized double-blinded, controlled~     trials have investigated the anxiolytic effects of melatonin before a surgery; however no~     studies to date have studied the anxiolytic effects of melatonin before less invasive~     interventional pain procedures. This study is designed to evaluate the efficacy of melatonin~     for reducing anxiety in patients undergoing a lumbar medial branch block procedure.~      The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each~     group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction~     in patients before undergoing the procedure. The primary outcome is measured by visual~     numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information~     Scale. Based on the results of previous studies, the investigators hypothesize that~     melatonin may reduce anxiety in patients undergoing the procedure and be a suitable~     alternative to intravenous sedation in the pain clinic for patients undergoing lumbar medial~     branch blocks.~   "
49032|NCT02415296|"~     The Internet medium is particularly vector for gambling problems. Since the opening of the~     online gambling sector in France, no screening for excessive gambling behaviours is provided~     for by the law, although it is known that preventive actions are more effective if they are~     implemented early in the gambler's career.~      The investigators propose to develop a model for screening excessive gambling practices~     based on the gambling behaviours observed on French gambling websites, coupled to a clinical~     validation. The objective is to lead to early preventive measures directed towards the more~     vulnerable gamblers and adapted for each type of gambling.~      This study will therefore contribute to setting up an innovative measure of prevention, to~     inform and protect gamblers as early as possible.~   "
49033|NCT02415283|"~     The Exalenz clinical investigation is a multicenter, non-randomized, study of the~     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to~     evaluate the capability of the OBT to differentiate between presence and absence of HCC~     determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.~   "
49034|NCT02415270|"~     The overall objectives of this clinical study are to determine in smokers the short term~     effects of switching to tobacco products that deliver low levels of nicotine or reactive~     oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke~     exposure and oxidative stress.~   "
49040|NCT02415192|"~     Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination~     drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium~     channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus,~     there's no enough safety data and efficacy data defined from the clinical study.~      Also, many combination drugs of valsartaa and amlodipine are widely used in the market.~      LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy~     (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this~     study.~   "
49041|NCT02415179|"~     The purpose of this study is to investigate the effectiveness of inhaled~     mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in~     treatment of asthma.~   "
49042|NCT02415166|"~     The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals~     with major depressive disorder (MDD) as well as to elucidate the nature of the immunological~     abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan~     to induce transient, mild inflammation in medically-healthy study participants using the~     influenza vaccine. Initially the investigators will conduct a pilot project with up to 20~     individuals in order to evaluate the time-point at which the peak inflammatory response to~     the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood~     samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both~     depressed and psychiatrically-healthy participants will be randomized in a parallel group,~     double-blind design so that they receive either influenza vaccine (seasonal vaccine) or~     saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating~     scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning~     with or without simultaneous EEG recording. Two-days post vaccination, they will provide a~     second blood sample, complete more clinical ratings and may complete another identical MRI~     session with or without simultaneous EEG. Four weeks later, participants will be asked to~     return to provide a third blood sample and complete additional clinical ratings. The blood~     samples will be used to measure both innate and adaptive immune function and may be used to~     correlate the vaccine-induced immunological changes to neurophysiological changes in the~     brain measured by MRI and/or EEG.~   "
49043|NCT02415153|"~     This phase I trial studies the side effects and best dose of pomalidomide in treating~     younger patients with tumors of the brain or spine (central nervous system) that have come~     back or are continuing to grow. Pomalidomide may interfere with the ability of tumor cells~     to grow and spread and may also stimulate the immune system to kill tumor cells.~   "
49044|NCT02415140|"~     Depression adversely affects quality of life in COPD patients, associated with higher rate~     of exacerbations, admissions and mortality. However, local prevalence rate of depression in~     geriatric COPD patients remains unknown.~      Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear~     which domain of BODE correlates best with depression. Furthermore, with multiple confounding~     factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for~     depression among COPD patients.~      The objective of this study is i.) to study the local prevalence rate of depression in~     geriatric COPD patients, ii.) to identify risk factors for depression especially looking at~     the any independent relationship between frequent exacerbations, various domains of BODE~     index and depression.~   "
49045|NCT02415127|"~     The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study~     is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of~     Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of~     ACTIMMUNE® in FA patients.~   "
49046|NCT02415114|"~     The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy~     subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of~     the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10~     when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include~     assessment of safety evaluations as determined by:~        -  laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT,~          and bilirubin~        -  vital signs - heart rate and blood pressure~        -  adverse events~   "
49047|NCT02415101|"~     This study compares outcomes with regard to the timing of resective surgery after~     neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients~     are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT.~     The study hypothesis is that a longer delay improves histological response and decreases the~     risk of postoperative morbidity and mortality.~   "
49048|NCT02415088|"~     This is a randomised, observer-blinded trial to compare selective shoulder block with~     interscalene block. Both blocks will be placed using an ultra-sound guided technique.~      Primary outcome measures will be postoperative pain scores and use of rescue opioids.~     Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the~     arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric~     rating scale and overall satisfaction with pain therapy as measured by the International~     Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very~     satisfied).~      Primary and secondary outcome measures will be assessed during the first 24hours after~     surgery (assessment in the postanesthetic care unit (PACU) directly after admission and~     before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).~      Overall satisfaction with pain therapy will be assessed 48hours after surgery.~      An interscalene block is a block of the plexus brachialis in the interscelene triangle (by~     injecting a local anesthetic around the nerve plexus).~      A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting~     a local anesthetic around these nerves).~   "
49049|NCT02415075|"~     The purpose of the study is to determine which factors on a personal, social and contextual~     level will help rehabilitation patients on returning to or continuing to work as well as to~     stay employable.~   "
49050|NCT02415062|"~     The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg)~     in Parkinson's disease with dementia compared to standard dose donepezil.~   "
49169|NCT02413515|"~     To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8~     weeks in Chinese hypertensive subjects who failed to achieve BP control with the~     starting-dose antihypertensive monotherapy.~   "
49051|NCT02415049|"~     There are several choices to consider when determining the timing of initiation of enteral~     feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as~     the infant awakens from anesthesia. Some authors have suggested a period of withholding~     feedings for several hours postoperatively, while others have recommended a significantly~     longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises~     over whether a physician chooses a standardized, incremental feeding regimen versus an ad~     libitum feeding schedule which allows the infant to decide when and how much to eat. Neither~     has been studied effectively in a randomized controlled setting. A recent review of the~     literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be~     the best postoperative regimen. This however, has not been studied in a randomized,~     controlled trial.~   "
49052|NCT02415036|"~     This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and~     safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or~     Intra Hepatic Cholangiocarcinoma (ICC) confined to the liver.~   "
49053|NCT02415023|"~     An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II~     dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric~     cancer who did not respond to first-line standard chemotherapy.~   "
49054|NCT02415010|"~     The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance~     and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil~     embolization of ruptured or non-ruptured intracranial aneurysms.~   "
49055|NCT02414997|"~     The purpose of this study is to determine the effect of remote ischemic preconditioning~     (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy~     adults and primary hypertensive patients stage I.~   "
49056|NCT02414984|"~     The purpose of this study is to describe adherence to golimumab in Colombian participants~     with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world~     clinical settings.~   "
49057|NCT02414971|"~     Project Study: Pilot Human Study Specific Aims: 1. describe levels of mitochondrial~     respiratory enzymes 2. examine relationships between levels of mitochondrial enzymes,~     fatigue, and health-related quality of life; and 3. compare levels of mitochondrial enzymes~     in men with a clinically-significant change in fatigue from those with no change in fatigue.~      Significance of Study: Cancer related fatigue is a common side effect of cancer. Cancer~     related fatigue is poorly understood. Many different biological mechanisms have been~     theorized, including mitochondrial dysfunction. Self-reported descriptions of reduced energy~     and muscle weakness lend support for a possible relationship of cancer related fatigue to~     mitochondrial dysfunction.~      Main Research Variables: Mitochondrial Enzymes, Cancer related fatigue, and health related~     quality of life Design: Descriptive, longitudinal study Sample/Setting: Men with~     non-metastatic prostate-cancer who are scheduled to receive radiation therapy Methods:~     Questionnaires, mouth swabs and blood will be collected at four study visits: prior to~     treatment, midpoint of treatment, completion of treatment and within 90 days of finishing~     treatment. Four mouth swabs will be collected per participant at each study visit.~      Implications for Practice: Understanding the role of mitochondrial enzymes in cancer related~     fatigue has major clinical implications in the development of targeted interventions and in~     providing specific knowledge for patients and their families to make informed treatment~     decisions.~   "
49058|NCT02414958|"~     Comparison of 2 doses of empagliflozin vs placebo in patients already using either an~     insulin regimen of MDI or CSII. Randomisation to 3 treatments arms (equal assignment)~     following a screening period, an optimisation period and a run-in period. 52 week~     double-blind treatment period, and 3 week follow-up period.~   "
49059|NCT02414945|"~     This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a~     type of cancer affecting the lining of the lung). Patients will receive an infusion (given~     by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood~     cells that recognizes tumor cells and enter them which causes the tumor cells to break down.~      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and~     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will~     receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen~     is in treating malignant pleural mesothelioma.~   "
49060|NCT02414932|"~     Depression affects up to 20% of people in their lifetime and can be a severe debilitating~     illness. Indeed, the World Health Organisation has estimated that depression will soon be~     the second leading contributor to the burden of disease worldwide. One of the big problems~     for patients and doctors is that currently available antidepressant drugs and~     psychotherapies do not work for 30% of people. However, about 60% of such~     treatment-resistant patients will recover fully with electroconvulsive therapy (ECT). Even~     though it was developed over 75 years ago, ECT continues to be the most powerful treatment~     for severe, often life-threatening, depression. Despite that, we have recently reported that~     severe depression symptoms return (called a relapse) in nearly 40% of such responders~     within six months of completing a course of ECT. Actually, such high relapse rates are seen~     for all patients with treatment-resistant depression, irrespective of what treatment they~     have received. There is thus an urgent need for better treatments to prevent relapse and one~     such possibility is an old drug called ketamine. Ketamine blocks the activity of glutamate,~     one of the major chemical messenger systems in the brain. Because of this effect it is~     sometimes used as an anaesthetic but it can also make you feel a bit high and so is~     sometimes abused as a recreational drug. Fortunately, in small doses it is quite safe.~     Recently, it has been found that ketamine has a remarkably rapid, but brief, antidepressant~     effect, including reducing suicidal thoughts. We wish to evaluate ketamine as a way to~     reduce relapse rates in people who have just been treated successfully with ECT for severe~     depression. Developing such a new treatment, and understanding how it works, would be of~     tremendous benefit to persons with severe depression, their families, and the wider society.~   "
49061|NCT02414919|"~     To assess the proportion of women who use HERC for ≥2 years of duration~   "
49062|NCT02414906|"~     Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to~     intensive care unit (ICU) and it is associated with increased morbimortality.~      There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI~     in the post operative phase in high-risk patients. We aimed to evaluate if the use of a~     goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury~     can decrease the prevalence of patients with acute renal failure.~   "
49170|NCT02413502|"~     The objective of this protocol is to obtain biological samples through leukapheresis and~     cryopreservation of cells for the future study, by in vitro assay, of immune responses after~     one dose of BCG in BCG-naïve healthy adults.~   "
49063|NCT02414893|"~     The mechanisms that regulate appetite in the morbidly obese are multifactorial and not~     well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an~     important role in the central regulation of appetite and hunger. Postprandial ghrelin and~     cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an~     effect on satiety sensation.~      On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also~     promotes changes in gastric emptying which are not clearly defined.~      Aim: To better understand the physiologic mechanisms involved in the regulation of hunger~     and satiety in morbidly obese individuals, especially those related with gallbladder and~     gastric emptying, as well as those related with the response of the gastrointestinal~     hormones ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric~     surgery (sleeve gastrectomy). Methodology: Three groups of individuals will be studied and~     compared: group A) non obese healthy subjects, group B) morbidly obese subjects and group C)~     morbidly obese subjects who had had a previous sleeve gastrectomy. In all subjects a~     standard meal test after a fasting night will be administered and appetite, satiety and~     hormonal response (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed,~     as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the~     paracetamol absorption technique.~   "
49064|NCT02414880|"~     Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes~     that substantially affects drug pharmacokinetics. Rocuronium onset time is longer and~     recovery time from it is prolonged in cirrhotic patients than in those with normal liver~     function.~      This randomized controlled study is designed to compare the pharmacodynamic profiles of~     sugammadex and neostigmine when used for the antagonism of moderate degree of~     rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and~     in patients with preoperative normal liver functions undergoing liver resection.~   "
49065|NCT02414867|"~     The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old~     children.~   "
49066|NCT02414854|"~     Primary Objective:~      To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent~     asthma.~      Secondary Objectives:~      To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in~     improving patient-reported outcomes including health-related quality of life.~      To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.~   "
49067|NCT02414841|"~     This research study is designed to assess the safety and effectiveness of an experimental~     drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive~     dialysis who have chronic kidney disease and who are undergoing surgery to create a new~     access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been~     shown in previous research studies to help keep vessels patent when applied to the outside~     surface of the blood vessels (arteries and veins) in patients who undergo surgery to create~     an arteriovenous fistula (AVF). The purpose of this study is to determine whether~     vonapanitase when applied to a limited segment of your blood vessel (about 2 inches)~     immediately after surgery is safe and improves the patency of your AVF.~   "
49068|NCT02414828|"~     This was a double-blind, randomized, placebo-controlled dose-escalation study in adults~     recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose~     groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time~     from the start of TB treatment. The on-TB-treatment stratum started TB treatment between 1~     and 4 months (30 to 120 calendar days) prior to Study Day 0. The post-TB-treatment stratum~     started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects~     were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects~     were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects~     were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or~     placebo.~   "
49069|NCT02414815|"~     Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of~     rate-dependent action potential duration(APD) adaptation is one of the characteristics of~     atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to~     utilize the monophasic action potential recording data from human patients in three groups,~     control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method~     to quantify the extent of electrical remodeling of ionic channel parameters using a~     mathematical model of atrial cell. Our approach will be useful in developing drug targets~     for ion channels in atrial fibrillation patients.~   "
49070|NCT02414802|"~     The purpose of this study is to determine whether the novel aspiration thrombectomy device~     combined with catheter-directed thrombolysis is effective in the treatment of acute~     iliofemoral deep venous thrombosis (IF-DVT).~   "
49071|NCT02414789|"~     Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass~     spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with~     the early skin manifestation (erythema migrans).~      This new proteomic method will be compared to the two existing method: culture of Borrelia~     and PCR detection of Borrelia (DNA detection of the bacteria).~   "
49072|NCT02414776|"~     To determine the safety and tolerability of orally administered hydroxychloroquine with~     hormonal therapy.~      To assess the response rate of hydroxychloroquine in combination with hormonal therapy.~   "
49073|NCT02414763|"~     The current study proposes to study the feasibility and acceptability of a brief~     psychosocial intervention delivered to suicide attempt survivors hospitalized on a~     medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center.~     The proposed study will involve training of care providers affiliated with Vanderbilt~     University Medical Center to deliver the brief intervention. Additionally, the participants~     will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including~     readiness to change problematic behaviors, engagement in outpatient mental health services,~     suicidal ideation, self-harming behavior, and reasons for living.~   "
49074|NCT02414750|"~     This is a single arm explorative phase II clinical trial in 90 subjects with advanced stage~     melanoma harbouring a BRAFV600 mutation. PET imaging and molecular diagnostics are combined~     in order to monitor response to treatment with vemurafenib plus cobimetinib, examine~     development of resistance and correlate changes in metabolic/proliferative activity with~     extend of target inhibition.~   "
49076|NCT02414724|"~     This phase I trial studies the side effects and best dose of ribociclib and gemcitabine~     hydrochloride in treating patients with solid tumors or lymphoma that have spread to other~     places in the body and usually cannot be cured or controlled with treatment. Ribociclib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving ribociclib together with gemcitabine~     hydrochloride may work better in treating patients with solid tumors or lymphoma.~   "
49077|NCT02414711|"~     Depression has emotional consequences, social and important business. Reaching at least 7.5%~     of French aged 15 to 85 years. General Practitioners are the first professional consulted in~     terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with~     depression that General Practitioners are often alone to support and follow. But General~     Practitioners are faced with diagnostic difficulties facing the diagnosis of depression,~     because if the patient does not engage itself, no tool is validated in France to help them~     in their diagnosis. However, standardized questionary exist that allow to overcome this~     difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was~     selected by a systematic review of literature and a RAND UCLA type of consensus procedure.~     This HSCL25 scale is the most efficient for the diagnosis of depression in terms of~     efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm~     its validity in terms of the French translation and in terms of efficiency.~   "
49078|NCT02414698|"~     To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet~     Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with~     lumbar radiculopathy due to contained disc herniation with symptoms that persist following a~     treatment course of conservative management including physical therapy and anti-inflammatory~     medication.~   "
49079|NCT02414685|"~     TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor~     markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until~     progression, unacceptable toxicity, complete response or inability of the subject to comply~     with study requirements.~   "
49080|NCT02414672|"~     The CareSTEPS intervention fills an important service gap by providing education, skills~     training, and support to the caregivers of advanced lung cancer patients on active~     treatment. The home-based delivery format will facilitate future dissemination and outreach.~     By empowering families with the skills they need to provide care and meet the challenges of~     lung cancer, this intervention holds great promise for improving caregiver quality of life~     (QOL), patient QOL, and the quality of palliative and supportive care services offered to~     patients with advanced cancer and their families.~   "
49081|NCT02414659|"~     Umbilical cord blood (UCB) collection and storage is a rapidly advancing field in hematology~     due to UCB's use for treatment of many hematological diseases, including but not limited to,~     Fanconi anemia, thalassemia, leukaemia and metabolic storage diseases. Primarily, there are~     two ways for UCB harvesting, first in-utero collection and second ex-utero collection.~     Depending on the amount of UCB collected, in-utero harvesting practice prolongs the~     operative time of cesarean delivery and speculatively increases intraoperative blood loss.~     The aim of this study is to determine UCB collection's effect on intraoperative bleeding in~     women undergoing elective cesarean delivery.~   "
49082|NCT02414646|"~     This phase II trial studies how well trastuzumab emtansine works in treating older patients~     with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer.~     HER2 is a protein found on the surface of cancer cells that helps them to grow and spread.~     Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of~     the tumor cells and blocking their ability grow and spread.~   "
49083|NCT02414633|"~     A special investigation (post marketing observational study (PMOS)/non-mandatory) of HUMIRA®~     will be performed for correlation between baseline and follow-up by clinical observation 24~     weeks (planned visit time; before the start of treatment, and at 4, 12, 16, and 24 weeks, 4~     data collection points) in Japanese psoriatic arthritis patients who are engaged in paid~     work.~   "
49084|NCT02414620|"~     The purpose of the research was to test the efficacy of the Dental Vibe Injection Comfort~     System. The study was conducted by faculty to have students as subjects to see if there are~     any differences in the comfort level of an ASA injection given on one side with topical~     anesthesia and lidocaine 1:100,000 with epinephrine using a standard syringe, and the other~     side uing the Dental Vibe, topical anesthesia and lidocaine 1:100,000 with epinephrine and a~     standard syringe. The Dental Vibe emits strong pulsed vibration which is transmitted via a~     silicone mouth piece to mucosal tissue. This in turn interferes with, blocks or reduces the~     perception of pain from the injection for the patient. It is stated that this phenomenon is~     achieved due to the gate theory of neuronal activity. There are also likely, distraction~     and placebo effects that contribute to the devices' efficacy.~   "
49085|NCT02414607|"~     Elderberries (Sambuci fructus) have been shown in a number of studies to have significant~     anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported~     the anti-inflammatory and antioxidant effects of elderberry preparations and it has been~     used in natural medicine for hundreds of years. Studies examining factors that may decrease~     the risk of Alzheimer's disease have revealed that drinking juices with similar properties~     to elderberries is one of the most reliable way to decrease risk. As such the investigators~     wish to determine the effects of elderberry juice on cognitive decline in a group of~     subjects at high risk for Alzheimer's disease, those with mild cognitive impairment.~     Elderberry juice is a commercially available nutritional supplement and easily available to~     this population.~   "
49086|NCT02414594|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.~   "
49087|NCT02414581|"~     Clinical triple-blind randomized controlled trial to assess the use of two different~     mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with~     chemotherapy~   "
49088|NCT02414568|"~     This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin~     Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in~     this study.~   "
49089|NCT02414555|"~     Background Intraoperative hypotension is a common problem that significantly contributes to~     perioperative mortality and morbidity. At the moment the gold standard for perioperative~     fluid management is the so called goal-directed therapy that features fluid resuscitation~     followed if necessary catecholamines if needed for perioperative cardiocirculatory support.~      Worldwide the so called physiological sodium chlorid (0.9% NaCl) solution is the most~     often used infusate for perioperative fluid management. Despite its widespread use~     physiological saline has its major disadvantages such as the increased incidence of~     metabolic acidosis. Nevertheless catecholamines have their significant side effects as well~     (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore~     should be used with caution.~      In a prior study by group members on patients undergoing renal transplantation receiving~     either physiological saline or an acetate-buffered infusate showed a 50% decrease in~     catecholamine necessity in the acetate-buffered infusate group. The investigators therefore~     would like to evaluate the effects of the perioperative fluid choice on the necessity of~     catecholamine use.~      Aim~        -  Evaluation of the perioperative fluid choice on the necessity of catecholamines for~          cardiocirculatory support.~        -  Description of the relationship between perioperative fluid choice and minimal blood~          pressure as well as the time to catecholamine use and their dosage.~      Methods The investigators plan a prospective randomized-controlled trial of all patients~     undergoing major abdominal surgery at the Vienna General Hospital and Medical University of~     Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based~     treatment scheme.~   "
49090|NCT02414542|"~     Post-marketing clinical study,international, multi-centre, prospective, observational. The~     investigation will be carried out in 2 sites in Europe for a maximum total number of 160~     patients.The aim of this study is to assess clinical, radiographic and subjective outcomes~     after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the~     survivorship of the implant and identify possible risk factors that may lead to failure.~   "
49091|NCT02414529|"~     The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D~     deficient obese children and adolescents will decrease the risk of getting diabetes (Disease~     in which the person has high blood sugar).~      The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically~     over the past 30 years. There are some reports suggesting that vitamin D supplementation in~     adults with pre diabetes (blood glucose higher than normal) and vitamin D treatment will~     prevent diabetes.~   "
49092|NCT02414516|"~     This Phase 1a, single center, open-label, repeat dose study will evaluate the safety,~     efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid~     tumors.~   "
49093|NCT02414503|"~     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate~     lactation in breastfeeding women. The intranasal administration of OT has recently attracted~     attention as a potential novel treatment in several psychiatric disorders in autism.~     However, given the anatomy of the nasal cavity, the current design of nasal sprays would be~     expected to provide an inadequate delivery of medication to the areas of the nasal cavity~     where direct transport into the brain via the olfactory nerve could potentially occur.~     OptiNose has developed an intranasal delivery device that provides improved reproducibility~     of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity~     where the olfactory nerve innervates the nasal cavity.~      The primary objective of this study is to identify any differences between a single dose of~     8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with~     the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be~     measured in terms of performance on cognitive tests and physiological markers.~   "
49094|NCT02414490|"~     This is a prospective observational study of 30 adult CIDP patients who receive home IVIg~     infusion services from AxelaCare Health Solutions, LLC. The decision to treat with IVIg will~     be entirely at the discretion of the patient's treating physician.~   "
49095|NCT02414477|"~     The purpose of this study is to better understand how people break down a tobacco specific~     cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco~     and cigarettes. Some people are able to get rid of this chemical as a harmless agent better~     than others. Through this research, the investigators hope to develop a better understanding~     of how people process potentially harmful chemicals and identify tobacco users who are in~     danger of developing cancer. Participants will complete questionnaires regarding their~     health and smoking history. The investigators will take blood samples, saliva samples, cheek~     cells and urine to measure exposure to toxins and harmful chemicals present in smokeless~     tobacco. Participants will be given smokeless tobacco study product and be asked to use only~     it for the entire time they are in the study. The study product contains deuterated NNN.~     Deuterated NNN is just like the NNN found in commercially available smokeless tobacco~     products, but is labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and~     safe. Using smokeless tobacco containing deuterium allows us to follow NNN as it is broken~     down in the body.~   "
49096|NCT02414464|"~     The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in~     young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.~   "
49097|NCT02414451|"~     The purpose of this study is to explore the effects of propranolol on social interaction,~     and secondarily on language, anxiety, adaptive behaviors, and global function in high~     functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot~     trial.~   "
49098|NCT02414438|"~     The study uses a randomized controlled study design of pediatric neurologists and~     developmental pediatricians and front-line (primary care) pediatricians to determine if use~     of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less~     variability in clinical practice, and lower costs from decreased resource utilization. The~     Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical~     encounter for individuals with an atypical phenotype and clinical presentation indicative of~     a possible genetic disorder. We will measure the difference in combined diagnostic and~     treatment CPV® domain score post-intervention versus baseline comparing intervention and~     control groups~   "
49215|NCT02412917|"~     This is a multicenter, randomized, double-blind, parallel-group, active controlled~     comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus~     valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes~     zoster).~   "
49099|NCT02414425|"~     Fecal incontinence is a frequent pathology which concerns 10% of the general population and~     severely alters patients quality of life. The cost of urinary and faecal incontinence has~     been estimated to be $16 billions a year. Several treatments exist depending on the~     aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve~     stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and~     are not without side effects, particularly the sacral nerve stimulation (pain, infection,~     electrode displacement..).~      The intravesical injections of botulinum toxin have been used for several years for the~     treatment of urinary incontinence with overactive bladder. Several randomized trials have~     demonstrated the efficacy of these injections in patients with neurological disorders and~     overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the~     detrusor muscle increase the compliance and the bladder capacity and delay the initial~     appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the~     urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor~     uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve~     afferents.~      The botulinum toxin should play a role on motor afferents as well as on the sensory function~     of efferent nerves.~      The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency~     episodes with improvement in quality of life, without any major side effects, in the~     patients included in this study. Nevertheless, the benefit of toxin injections are known to~     be temporary because of nerve re-growth. If we obtain similar results for fecal~     incontinence, it would be possible to schedule one to two injections a year because of the~     limited side-effects and invasiveness of the rectal injections.~   "
49100|NCT02414412|"~     This randomized, placebo-controlled, double-blind study evaluates the efficacy and~     tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively~     healthy adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a~     placebo for 4 weeks.~   "
49101|NCT02414399|"~     Children hospitalized with severe illness in sub-Saharan Africa are at high risk of~     morbidity and mortality following discharge from hospital. These children represent an~     accessible high-risk population in which targeted interventions to prevent morbidity and~     mortality could have dramatic impact. A large cluster randomized trial of azithromycin~     delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan~     Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated~     communities. However, mass drug administration of azithromycin leads to the rapid emergence~     of macrolide resistance within treated communities and is expensive. The targeted delivery~     of azithromycin to children at hospital discharge may be a novel and practical intervention~     to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized,~     double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at~     discharge, compared to placebo, in reducing mortality and re-hospitalization rates in~     children age 1-59 months in Kenya. The study will also investigate potential mechanisms by~     which azithromycin may reduce morbidity and mortality in this population and will assess the~     emergence of antibiotic resistance among treated individuals and their primary caregivers. A~     cost-effectiveness analysis of the intervention will also be conducted.~   "
49102|NCT02414386|"~     Several studies point at a potential relationship between vitamin D deficiency and worse~     outcome in critically ill patients admitted to the intensive care unit. It is linked with~     the lack of vitamin D pleiotropic effects in the state of hypovitaminosis D. The~     pleiotropism of vitamin D is dependent on a specific feature of vitamin D receptor (VDR)~     namely polymorphism and its universal existence in the human body. Vitamin D pleiotropism is~     linked with cancer cells inhibition, a modulation of the immune system, an influence on~     cardiovascular system and neuroprotection.~      In 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney~     injury (AKI) is diagnosed. Acute kidney injury increases significantly the probability of~     death. The standard therapy of a severe AKI in many intensive care units is the regional~     citrate anticoagulation continuous renal replacement therapy by means of continuous~     veno-venous hemodiafiltration (CVVHDF). The specificity of the regional citrate~     anticoagulation by means of precise ionized calcium and citrate dosing evokes questions~     regarding its influence on vitamin D and entire calcium-phosphate metabolism in the state of~     a severe AKI treated with regional citrate anticoagulation continuous renal replacement~     therapy.~      The intention of that trial is to measure vitamin D plasma levels and other parameters~     (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked~     with calcium-phosphate metabolism in the human body. We would like to assess potential~     relationships between the regional citrate anticoagulation continuous renal replacement~     therapy and these parameters.~   "
49103|NCT02414373|"~     Acute urinary retention is one of the most common complications after surgery and~     anesthesia. Micturition depends on coordinated actions between the detrusor muscle and the~     external urethral sphincter. Under the influence of epidural analgesia, patients may not~     feel the sensation of bladder filling, which can result in urinary retention and bladder~     overdistension. Overfilling of the bladder can stretch and in some cases permanently damage~     the detrusor muscle. Because epidural anesthesia can be performed at various levels of the~     spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade).~     Thoracic epidural analgesia with bupivacaine significantly inhibits the detrusor muscle~     during voiding, resulting in clinically relevant post void residuals which required~     monitoring or transurethral catheterisation. This bladder muscle inhibition is comparable to~     a motor blockade. The epidural administration of ropivacaine during labour results in a~     clinically relevant reduction of motor blocks.~      The hypothesis is that thoracic epidural analgesia with the local anesthetics ropivacaine~     leads to less significant changes in bladder function than bupivacaine as a control group,~     in patients undergoing lumbotomy incision for renal surgery.~   "
49104|NCT02414360|"~     The purpose of this pilot study is to determine the feasibility of running a full-scale~     trial that compares two formats of a shortened systematic review to a full-length systematic~     review to be used in clinical decision-making.~   "
49105|NCT02414347|"~     This project will collect quantitative pilot data that will allow the characterization of~     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound,~     in individuals with and without brain tau fibrils. The primary goal is to develop tau~     imaging technique as an antecedent biomarker of cognitive decline. The investigators propose~     to obtain preliminary data that will support the possibility of detecting cognitive decline~     in its earliest stages, before the occurrence of dementia.~   "
49118|NCT02414178|"~     The purpose of this research study is to evaluate a new radioactive compound used in~     positron emission tomography (PET) scans in identifying tau tangles (a certain protein that~     might be associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the~     amount of tau tangles in the brain has a relationship to cognitive status.~      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of~     tau deposition. This radioactive compound is not approved by the United States Food and Drug~     Administration (FDA). An MRI may also be conducted.~   "
49106|NCT02414334|"~     Rationale:~      SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides~     surgical resection for limited lung metastases (oligometastases) from colorectal cancer.~     High efficacy in terms of local control of metastatic lesions treated has been shown.~     Nevertheless, the precise effect of SABR upon progression-free- and overall survival in~     these patients is unknown. To further evaluate and develop local treatment options in~     metastatic disease, more information is necessary regarding the impact upon - and the~     pattern of - disease progression of local treatment options such as SABR.~      Objective:~      To determine the effect upon progression free survival and upon tumorload relative to~     baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a~     scan-and-personalise policy). Secondarily, patterns of progression, patient-reported~     symptoms and quality of life will be monitored.~   "
49107|NCT02414321|"~     This study aims to explore the structural and functional characteristics of the pulmonary~     vasculature in adult Fontan patients.~      Objectives:~        -  Determine the effect of pulmonary vasodilatation on indexed cardiac output during~          simulated exercise.~        -  Characterization of structural properties of small pulmonary arteries.~   "
49108|NCT02414308|"~     Erectile dysfunction is growing in prevalence all over the world and one of the most~     existing disease in old age patients There is many lines of treatment concerning the status~     of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is~     common now among people especially diabetics, and the role of treatment still controversial~     in results We can start conservative treatment and then surgical treatment if fail but the~     outcome still not convinced Many patients refuse to fix penile prosthesis and to make~     operation like nesbite for probability of shortening of penis We start to use stem cell in~     patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be~     at corpora cavernosa and intra dorsal penile artery under Doppler device guidance~   "
49109|NCT02414295|"~     Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical~     findings are nonspecific during childhood; thus, the diagnosis commonly is made during~     adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism~     and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.~      Approximately one in 1,000 boys is born with an additional X chromosome—47,XXY, the~     karyotype that causes Klinefelter syndrome. This karyotype is detected at or before birth in~     10 percent of affected boys, and it is found during adulthood in 25 percent of affected men.~     Almost all men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for~     3 percent of male infertility.~      Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10~     percent).~      Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count.~     If sperm are present, cryopreservation is useful for future family planning with~     intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued.~     Although there have been multiple reports of successful fertilization by men with~     Klinefelter syndrome.~      Mesenchymal stem cell injection in testicular tubules and intra testicular artery using~     surgical microscope.~      The period for follow up last from three months to twelve months including semen analysis to~     detect sperm and hormonal profile .~   "
49110|NCT02414282|"~     This project will collect quantitative pilot data that will allow the characterization of~     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound,~     in individuals with Progressive Posterior Cortical Dysfunction (PPCD). The primary goal is~     to develop tau imaging technique as an antecedent biomarker of cognitive decline. The~     investigators propose to obtain preliminary data that will support the possibility of~     detecting cognitive decline in its earliest stages, before the occurrence of dementia.~   "
49111|NCT02414269|"~     The purpose of this Phase I study is to test the safety of different doses of specially~     prepared immune cells (called T cells) collected from blood. The Investigators want to~     find a safe dose of these modified T cells for patients who have malignant pleural disease.~     They want to find out what effects these T cells have on the patient and the cancer (MPD).~   "
49112|NCT02414256|"~     We will enroll patients submitted to breast surgery (in and outsettings) with regional~     anesthesia.~      The blinded observers, in the first 48 hours post-operative, will evaluate (telephone~     interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain,~     10 = worst possible pain) thereby recording the treatment procedures in accordance with~     usual clinical practice. At the same time we will evaluate the presence of intraoperative or~     postoperative complications related to regional anesthesia, the PONV rate (post-operative~     nausea and vomiting) and the analgesic/antiemetic therapy.~   "
49113|NCT02414243|"~     This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of~     the new amino acid-based formula in infants and children aged< 12 years with documented~     cow's milk protein allergy (CMPA).~   "
49114|NCT02414230|"~     The purpose of this research study is to evaluate tau distribution in the brain of subjects~     with: ALS caused by different genetic mutations, any mutation carriers (with or without~     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.~   "
49115|NCT02414217|"~     The objective of this project is to test two interventions designed to improve~     diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People~     with diabetes use numbers in a variety of ways in managing their condition (e.g.,~     understanding blood sugar values, counting carbohydrates, taking medications at the right~     dose and time). As part of this project, the investigators will develop and pilot test two~     interventions to improve diabetes-related numeracy: (1) a series of in-person education~     classes and (2) a one-time, online diabetes education class. The investigators will look to~     see whether participants in the education classes show improvements in their~     diabetes-related numeracy skills, self-care behavior and attitudes, and clinical outcomes~     (i.e., body mass index, blood pressure, blood sugar [A1c]).~   "
49116|NCT02414204|"~     Patients with stage IV and V chronic kidney disease and end stage renal disease requiring~     hemodialysis at UAB Dialysis Clinics will be recruited from the UAB Vascular Access Clinic,~     which has been the site for recruitment of patients requiring new vascular access for the~     last 10 years.~   "
49117|NCT02414191|"~     The investigators aim to assess the impact of benchmarked and ranked feedback on~     anesthesiologists' perioperative temperature management and subsequent patient outcomes.~   "
49119|NCT02414165|"~     This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus~     standard of care that comprises Investigator's choice of single agent chemotherapy~     (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for~     first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of~     the inclusion and none of the exclusion criteria will be randomized prior to surgery in a~     1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control~     treatment with one option of standard of care (Arm SOC). Due to the prognostic influence of~     molecular subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified~     based on this determination from the primary pathology or subsequent biopsy known locally or~     otherwise determined centrally. A second stratification factor is based on the patient's~     Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential~     differences in treatment choices for the control arm in regions, the trial will be~     stratified by geographical region during the randomization process. The study will be~     conducted in 2 parts; enrollment in the phase 3 will begin after phase 2 results are~     available.~   "
49120|NCT02414152|"~     The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist)~     can improve hearing thresholds in patients with sudden sensorineural hearing loss that did~     not respond to oral steroid therapy. The patients to be enrolled will have recently~     completed a course of oral steroids and demonstrated no change in their audiometric~     thresholds following corticosteroid therapy.~      The investigators will be measuring hearing thresholds (Pure tone average and word~     recognition scores) before and after anakinra and correlating these findings with~     circulating IL-1 levels in the patient's blood.~   "
49121|NCT02414139|"~     A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult~     patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by~     overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of~     INC280.~   "
49122|NCT02414126|"~     Adult patients with heart failure (HF) have an increased work of breathing and are at~     increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous~     positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing~     and improving sleep-disordered breathing in these patients.~      The aim of the study is to analyze the work of breathing and objective and subjective sleep~     quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the~     work of breathing and improve cardiac output during wakefulness.~   "
49123|NCT02414113|"~     Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine~     clinical practice, this blinded prospective study will be carried out for assessment of~     severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors~     for allogeneic hematopoietic peripheral blood stem cell transplant. The objective of this~     prospective study is to show: (a) that GVHD reductions and donor availabilities as observed~     in the retrospective studies also apply to prospective samples that are collected and~     processed from on-going matched unrelated transplants, and (b) that high-GNOS donor~     selection readily fits into today's donor selection process, such as to facilitate access to~     the benefits of GVHD reduction. The prospective study is designed to be blinded, and will~     not involve specific donor selection nor any influence on clinical management or decision~     making by application of the GNOS technology.~      To determine if some GNOS models perform better than others across different clinical~     centers, or across different recipient / donor attributes, 4 different specific GNOS models~     will be evaluated. Bootstrap computational analyses have been carried out on the~     retrospective data for the 4 GNOS models and will be tested and validated in this~     prospective study.~   "
49124|NCT02414100|"~     This pilot research trial studies patient derived cancer cell lines in identifying molecular~     changes in patients with previously untreated pancreatic cancer and are receiving~     gemcitabine hydrochloride-based chemotherapy. Cell lines refer to samples taken from the~     patient's tumor to grow for many months or years in a laboratory, and can therefore be~     studied scientifically. Studying cell lines in the laboratory may help doctors understand~     the genetic changes that occur to the tumor during chemotherapy that allows the tumor to~     resist or grow despite treatment.~   "
49125|NCT02414087|"~     Using double blind, randomized controlled design to study the short-term therapeutic effects~     of customized arch-support shoe insoles to children with flat foot.~   "
49126|NCT02414074|"~     This pilot study conducts feasibility research to develop adaptive intervention strategies~     for conduct problems prevention. The adaptive model will stipulate for whom only brief~     prevention strategies are sufficient and for whom more intensive strategies are necessary.~     The research will involve youth (10-17 years of age) identified by law enforcement as early~     offenders and who are referred for pre-court juvenile diversion programming.~   "
49127|NCT02414061|"~     The purpose of this study is to investigate whether the addition of whey protein to a~     breakfast high in carbohydrate content will influence acute metabolic and appetite~     responses, as well as responses to a subsequent lunch meal.~   "
49128|NCT02414048|"~     The primary objective is the prospective determination of disease-specific and overall~     survival in head and neck cancer patients who have undergone surgery, correlated to~     non-invasive methods of measuring tumour hypoxia.~      The secondary objective is to define tumour hypoxia using non-invasive methodology.~   "
49129|NCT02414035|"~     The purpose of this study is to determine whether dabigatran is associated with higher risk~     of bleeding in Asia area especially in China clinical practice and whether it need to set up~     a monitor system.~   "
49130|NCT02414022|"~     The planned analysis is a prospective cost-effectiveness (cost-utility) analysis from the~     perspective of the Canadian public healthcare system, examining the costs and outcomes~     (quality-adjusted life years gained) of ibrutinib-based therapy compared to a standard~     therapy (bendamutine-rituximab). Collection and management of the data required for the~     economic analyses (including resource utilization and outcomes) will be fully integrated~     into the clinical data. Health state utilities will be derived directly from the study~     population.~   "
49142|NCT02413866|"~     The purpose of this study is to examine whether chronic moderate sleep restriction effects~     the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are~     participating in a dietary weight loss program.~   "
49131|NCT02414009|"~     Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of~     CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC~     patients who have progressed on or after first-line oxaliplatin containing chemotherapy for~     metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione~     IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained~     sections on charged slides of tumor will be required and methylation status will be provided~     within a maximum of seven days to the Study Centers. Presence of RAS mutation will be~     assessed at each local participating center. Eligible patients will be randomized in a 1:1~     ratio to one of two treatment arms:~        -  Arm A (experimental arm): CAPTEM~        -  Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28~          days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine~          at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus~          temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B~          will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of~          Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only;~          5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2,~          respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting~          dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles~          in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable~          toxicity or informed consent withdrawal. Randomization will be stratified across the~          treatment arms by the following predefined stratification variables: disease~          progression within 9 months from the start of first-line oxaliplatin-containing~          chemotherapy (< vs. ≥9 months); prior bevacizumab in combination with oxaliplatin-based~          chemotherapy (yes vs. no). Efficacy assessments will be performed every 2 cycles in Arm~          A and every 4 cycles in Arm B until progression. The study is expected to enrol~          approximately 82 patients who meet the eligibility criteria.~   "
49132|NCT02413996|"~     The aim of this study is to assess the efficacy of virtual rehabilitation through the~     Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the~     functional outcomes after primary Total Knee Arthroplasty (TKA).~   "
49133|NCT02413983|"~     Living donor liver transplantation (LDLT) is an important option for patients with end-stage~     liver disease requiring liver transplantation. When performing LDLT, the safety and well~     being of donors is of the utmost importance. The conventional incision for donor hepatectomy~     is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive~     liver surgery throughout a single 10 cm upper midline incision without laparoscopic~     assistance has been widely applied and considered to be safe and effective. Recently,~     laparoscopic and minimally invasive living donor hepatectomy via transverse incision has~     been suggested to reduce morbidity and the invasiveness of living donor hepatectomy.~     Although minimally invasive approach has become the surgical method of choice for many~     transplant centers, little data on comparing the impact of all three different type incision~     in living liver donors. In our center, the investigators have adopted three different~     incision according to surgical teams. The investigators undertook this study with the aims~     of comparing the pain and quality of life of donors according to type of three different~     incisions and assessing any benefits to the donor due to the smaller midline incision during~     the early postoperative period.~   "
49134|NCT02413970|"~     The purpose of this study is to obtain additional long-term safety and efficacy data on the~     use of Inspire therapy.~   "
49135|NCT02413957|"~     The purpose of this study is to determine wether an extensive medication safety check has a~     greater impact on the incidence of adverse drug events than medication reconciliation or no~     intervention.~   "
49136|NCT02413944|"~     Study objectives: First, to determine whether intravenous injection of 1 mcg~     adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides~     reliable results of cortisol response, and whether this method would replace the~     conventional technique of injecting ACTH by a needle directly into a peripheral vein.~     Secondly, to determine salivary free cortisol concentration during the test in healthy~     controls.~      Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous~     short cannula appears to be feasible and simple method. On the other hand, injection of~     ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by~     technical problems in subjects with challenging veins. The investigators suppose that, both~     methods would have the same yield in predicting cortisol response.~      Salivary free cortisol test has an evolving importance in assessing the adrenal function.~     This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The~     investigators will examine the concentration of salivary free cortisol during ACTH~     stimulation test, in order to determine level range in normal controls.~   "
49137|NCT02413931|"~     Single-center, observational, prospective cohort study including patients hospitalized on~     the multidrug-resistant tuberculosis ward at Marius Nasta Institute.~      The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great~     concern. The current study that will be conducted at the Marius Nasta Institute, one of two~     nationwide excellence treatment centers for MDR-TB in Romania, is aiming to prospectively~     investigate the population structure of patients with MDR-TB admitted for treatment and the~     M. tuberculosis strains isolated from these patients. Transmission of MDR- strains of~     Mycobacterium tuberculosis among patients hospitalized there will be also ascertained.~     Additionally biomarkers for treatment response during the course of the tuberculosis therapy~     will be evaluated.~      The study will be conducted in a co-operation between the Marius Nasta Institute and the~     German Center for Infection Research (DZIF).~   "
49138|NCT02413918|"~     1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct~          to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any~          combination of the three thereof, in a group of patients with an index episode of a~          mixed state in BD.~        2. To assess background, baseline features, and behavioral components which characterize~          treatment response/non-response in the acute and long term management of MS~   "
49139|NCT02413905|"~     The investigators performed two case-control studies in Niger and Senegal analysing fecal~     microbiota to characterize the specificity of the gut microbiota alteration associated with~     severe acute malnutrition (SAM).~   "
49140|NCT02413892|"~     Echinocandins are the drug of choice in severe candida infections. Efficacy of echinocandins~     is related to concentration and area under the curve (AUC) of the drug.~      Available pharmacokinetic studies found that concentration of echinocandins mainly~     caspofungin is sub-optimal in severe candida infections in intensive care unit (ICU)~     patients.~      Higher dose of caspofungin has been proven to be safe in critically ill patients but its~     impact on the ability to reach PK/PD target is unknown.~      The aim of this study is to evaluate the impact of a loading dose of caspofungin on PK/PD~     parameters within the first 24-hours.~   "
49141|NCT02413879|"~     This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound~     Retraction and Protection System in Protecting Surgical Incisions from Intraoperative~     Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at~     the wound incision site when the CleanCision is used during surgery.~   "
49143|NCT02413853|"~     This randomized phase II trial studies how well combination chemotherapy and bevacizumab~     with or without CBP/beta-catenin antagonist PRI-724 (PRI-724) works in treating patients~     with newly diagnosed colorectal cancer that has spread to other places in the body. Drugs~     used in chemotherapy, such as leucovorin calcium, oxaliplatin, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells. PRI-724~     may help stop the growth of cancer cells by blocking the specific signaling pathway that~     cancer cells need to grow and spread. It is not yet known whether combination chemotherapy~     and bevacizumab works better with or without PRI-724 in treating patients with metastatic~     colorectal cancer.~   "
49144|NCT02413840|"~     This study expect to investigate psychological intervention (Baduanjin qigong) in COPD~     patients combined with anxiety and/or depression.~   "
49145|NCT02413827|"~     This is a study to determine the clinical benefit (how well the drug works), safety and~     tolerability of combining a) varlilumab and ipilimumab and b) varlilumab, ipilimumab,~     CDX-1401 and poly-ICLC. The study will enroll patients with unresectable Stage III or Stage~     IV melanoma.~   "
49146|NCT02413814|"~     Problematic anger is a strong predictor of failed attempts at smoking cessation. The~     investigators proposed study seeks to evaluate whether a novel 8-session computerized~     anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait~     anger will be administered transdermal nicotine patch therapy and either anger-reduction~     treatment or a control intervention. They will be assessed throughout treatment and up until~     three months after a scheduled mid- treatment quit date. The investigators propose to test~     whether, compared to the control condition, the anger-reduction treatment will lead to: 1)~     greater reductions in anger and 2) greater abstinence rates at post-cessation and at~     follow-up assessments. The investigators will also test whether changes in anger-related~     symptoms account for group differences in abstinence rates.~   "
49147|NCT02413801|"~     The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not~     well understood. This conversion occurs 30% of the time within the first 10 years of~     psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within~     the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in~     psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in~     psoriasis patients and provide a better understanding of the underlying molecular~     pathogenesis that may lead to development of new therapeutic targets in PsA.~   "
49148|NCT02413788|"~     Inflammatory markers have been analyzed in several diseases of unknown etiology, in the~     expectation of increasing therapeutic perspectives. This possibility arises from the~     different levels of tissue injury with low-grade chronic inflammation that have been~     observed in studies in which the markers were not evaluated traditionally, and today have~     influenced clinical management.~      The investigators aimed, therefore, to evaluate the inflammatory markers in patients with~     AIS before and after aerobic and combined exercise training.~   "
49149|NCT02413775|"~     One goal of the investigators of the Department of Anesthesiology and Intensive Care~     Medicine CVK/CCM, Charité - University Medicine Berlin is a continuous improvement in the~     quality of care to the patients. One focus is the freezing preoperatively during surgery,~     and on the follow-up study to assess the perceived waiting times in the anesthesiology~     outpatient clinic.~      The project aims to quality assurance and quality improvement of the Department of~     Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin .~   "
49150|NCT02413762|"~     This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron~     regulatory hormone hepcidin as biomarkers for progression to complications in diabetes~     mellitus.~   "
49151|NCT02413749|"~     Biologics such as anti-Tumor Necrosis Factor or TNF inhibitor (TNFi) for treatment of~     Psoriatic Arthritis (PsA) has greatly reduced bone damage. This collaborative study will~     provide insights into key mechanisms that underlie inflammatory arthritis and bone damage in~     psoriatic joints and will catalyze biomarker discovery, identifying early biologic~     responders to facilitate optimization of therapy.~   "
49152|NCT02413736|"~     In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)~     and have been treated with adjuvant imatinib for 3 years after surgery will be randomly~     allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop~     imatinib (Arm B). The study participants are required to have histologically verified GIST~     with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at~     surgery and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one~     of the following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the~     microscope, non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study~     participants allocated to Arm A will receive imatinib 400 mg/day for 24 months after the~     date of randomization. All study participants will be followed up using blood tests and~     computerized tomography (or MRI) of the abdomen. The computerized tomography examinations~     will be performed at 6 month intervals. A total of 300 patients will be entered to the~     study. The study hypothesis is that adjuvant imatinib given for a total of 5 years may~     prevent some of the GISTs to recur as compared to patients who receive adjuvant imatinib for~     3 years, and there may be a difference in the rate of GIST recurrence between the two~     groups.~   "
49153|NCT02413723|"~     The aim of this study is to demonstrate that the rate of successful orotracheal intubation~     at first laryngoscopy will be higher in patients intubated with McGrath Mac~     videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in~     patients requiring an orotracheal intubation in ICU.~   "
49154|NCT02413710|"~     The aim of this clinical trial is to assess the effects of daily consumption of soy protein~     foods on body composition, general health status and dietary intake outcomes in generally~     healthy children.~   "
49167|NCT02413541|"~     This research project is a study to immunology changes in critically ill patients with~     severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B~     Hemoperfusion.~   "
49327|NCT02411461|"~     Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and~     learning difficulties. This study will investigate eating behaviors and perform cognitive~     testing on children with PHP1a. The investigators will compare their results to those of~     healthy siblings and other obese children.~   "
49155|NCT02413697|"~     Objectives: To assess whether embryo transfer guided by three-dimensional ultrasound (3DUS)~     produces a significantly higher clinical pregnancy rate than embryo transfer guided by~     two-dimensional ultrasound (2DUS).~      Hypothesis: 3DUS guided embryo transfer will produce a significantly higher clinical~     pregnancy rate compared with 2DUS guided embryo transfer. Design and subjects: Prospective~     randomised control trial (RCT) at the Prince of Wales Hospital. Inclusion criteria include~     women undergoing embryo transfer in fresh and frozen cycles. Exclusion criteria include~     women aged >42 years and women whose endometrial cavity cannot be visualised adequately via~     US. Power calculations indicate that 232 patients per arm are required to demonstrate an~     increase of 12% in clinical pregnancy rates.~      Study instruments: US examinations will be performed using a General Electric(GE) Voluson~     series US machine with a standard 3D transvaginal probe. For embryo transfer, the Cooks~     Guardia Access EchoTip catheter will be used.~      Interventions: 3D versus 2DUS for guidance during embryo transfer. Main outcome measures:~     clinical pregnancy. Secondary outcome measures: implantation rate, multiple pregnancy,~     miscarriage, ectopic pregnancy and live birth rates.~      Data analysis: Data processing and analysis will be performed using the Statistical Packages~     of Social Sciences for Windows (SPSS, Inc). Descriptive and comparative statistical methods~     will be used to analyse the primary outcomes. P-values of <0.05 will be considered~     significant.~      Expected results: The study arm undergoing 3DUS guided embryo transfer are expected to have~     an improved clinical pregnancy rate compared with the control arm undergoing 2DUS guided~     embryo transfer.~   "
49156|NCT02413684|"~     The purpose of this study is to test the impact of an innovative patient engagement solution~     on patient's quality of life and asthma-related outcomes, and evaluate the correlation~     between a patient reported outcome measure and clinical outcomes.~   "
49157|NCT02413671|"~     The study compared the acute effects of the supplementation of a standardized meal with~     either lupin or whey protein or no protein on the whole-body glucose and insuline~     metabolism.~   "
49158|NCT02413658|"~     The purpose of this study is to investigate the potential healing properties of phenytoin.~      The investigators will use the donor site of a split skin thickness graft (SSTG) to model a~     basic wound in a randomized controlled trial of topical phenytoin against current best~     clinical practice. The investigators aim to demonstrate a dose dependent effect. The~     investigators hypothesis, based on previous clinical experience at our center and on current~     available literature, that phenytoin will reduce wound healing time.~   "
49159|NCT02413645|"~     The mai purpose of the study is to evaluate the safety and to establish the recommended dose~     of iHIVARNA-01 as a new therapeutic vaccine against HIV~   "
49160|NCT02413632|"~     Comparison of two screening strategies of asymptomatic sexually transmitted infections :~     routine screening versus screening as reported by the risks taken by the patient, in a~     cohort of HIV outpatients men who have sex with men. The aim of this study will be create~     and validate a simple tool for clinicians. A digital tool will be developed will allowed~     empowerment of HIV-positive men who have sex with men.~   "
49161|NCT02413619|"~     Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually~     developed, which requires a cataract surgery.~      The aim of this study is to investigate the refractive consequences of surgery for~     Epiretinal membrane and cataract.~      Investigators investigate the sequence of surgery in patients having surgery for Epiretinal~     membrane and cataract in a prospective clinically randomized intervention trial. Patients~     are randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined~     surgery. Investigators want to find the sequence of surgery that gives the most optimal~     refractive result, the most stabile intraocular lens, and the minimal loss of corneal~     endothelial cells.~   "
49162|NCT02413606|"~     Background: It has often been hypothesized that the frequency of follow-up for patients with~     early-stage endometrial cancer could be decreased. However, studies evaluating effects of a~     reduced follow-up schedule among this patient group are lacking.~      Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up~     schedule compared to the schedule according to the Dutch guideline.~      Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up.~     Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3~     years, and a control group with 10-13 follow-up visits during 5 years, according to the~     Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and~     60 months. Patient inclusion will take two years (if 60% of the patients participate).~      Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.~      Secondary: health care use, adherence to schedule, health-related quality of life, fear of~     recurrence, anxiety and depression, information provision, recurrence, survival~      Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant~     radiotherapy is not indicated~      Statistics: linear regression analyses to assess differences in patient satisfaction with~     follow-up care between intervention and control group adjusted for potential pre-defined~     confounders.~      Expected results: Patients in the intervention arm have a similar satisfaction with~     follow-up care and overall outcomes, but lower health care use and costs than patients in~     the control arm. No effects are expected on QALY differences (losses) and satisfaction, but~     the reduced schedule is expected to save 144.000 per year in the Netherlands.~   "
49163|NCT02413593|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in~     treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.~   "
49164|NCT02413580|"~     This is a multicenter, prospective, open-label, non-controlled study to assess the efficacy~     and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.~   "
49165|NCT02413567|"~     The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR)~     Procedure for the treatment of Type 2 Diabetes.~   "
49166|NCT02413554|"~     Delirium is a common and serious condition and is associated with adverse outcome. The~     elderly who have cognitive dysfunction are expected to show delirium more frequently. It is~     most likely that delirium represents a response to impaired cholinergic neurotransmission.~     Investigators aimed to establish the preventive effect of the cholinesterase inhibitor,~     rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation~     in patients at risk of dementia.~   "
49171|NCT02413489|"~     The purpose of this study is to assess overall response rate [ORR, including complete~     response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's~     lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between~     ORR and CD38 expression level in order to determine a threshold for CD38 expression level in~     each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed~     or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.~   "
49172|NCT02413476|"~     The study aims to compare the clinical outcomes between robotic-assisted and~     laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and~     safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who~     are more suitable for robotic gastrectomy.~   "
49173|NCT02413463|"~     Prospective randomized interventional comparative study~   "
49174|NCT02413450|"~     Human induced pluripotent stem cells (hiPSCs) have driven a paradigm shift in the modeling~     of human disease; the ability to reprogram patient-specific cells holds the promise of an~     enhanced understanding of disease mechanisms and phenotypic variability, with applications~     in personalized predictive pharmacology/toxicology, cell therapy and regenerative medicine.~     This research will collect blood or skin biopsies from patients and healthy controls for the~     purpose of generating cell and tissue models of Mendelian heritable forms of heart disease~     focusing on cardiomyopathies, channelopathies and neuromuscular diseases. Cardiomyocytes~     derived from hiPSCs will provide a ready source of disease specific cells to study~     pathogenesis and therapeutics.~   "
49175|NCT02413437|"~     The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound~     in percutaneous biopsy for liver occupied lesion.~   "
49176|NCT02413424|"~     The purpose of this research study is to examine whether sugar-replacement sweeteners that~     are currently on the market (ex. Sucralose, which is in Splenda) change how well the body~     works to control blood sugar.~   "
49177|NCT02413411|"~     A randomized, controlled design will be utilized to examine and compare the effectiveness of~     the proposed educational intervention, which includes a combination of an educational~     decision aid and motivational interviewing with attention control on select key~     patient-centered and process of care outcomes. The study sample will consist of~     approximately 450 African-American patients with osteoarthritis of the knee. Patients will~     be recruited from the University of Pennsylvania Health System and the Philadelphia VA~     Medical Center and will be randomized to one of the two study arms.~      The immediate goal of this randomized controlled trial is to assess the effect of a~     high-quality, evidence-based, patient-centered educational intervention supplemented with~     targeted counseling (motivational interviewing) on African American patient preferences,~     expectations, and the likelihood of achieving a referral for surgical evaluation. The~     long-term goal of this research is to widely implement a patient-centered educational~     intervention targeting African Americans who are potential candidates for joint replacement,~     in a national effort to reduce and ultimately eliminate racial disparities in the~     utilization of this effective treatment option.~      Study Aim:To examine the effect of the knee osteoarthritis Decision Aid (DA)/Motivational~     Interviewing (MI) intervention on orthopedic surgery referral rates for African American~     (AA) patients. Hypothesis: Compared to attention control, the DA/MI intervention will lead~     to higher orthopedic surgery referral rates for AA patients.~      Secondary aim: To examine the effect of the DA/MI intervention on the rate of knee~     replacement receipt among AA patients. Hypothesis: AA patients randomized to receive the~     intervention will have higher rates of knee replacement compared to those in the attention~     control group.~   "
49178|NCT02413398|"~     The purpose of this clinical research study is to determine whether dapagliflozin can~     improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal~     impairment.This study will be conducted at approximately 100 centres from countries across~     North America and European regions. It is planned to randomize a total of 302 patients.~   "
49179|NCT02413385|"~     The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle~     prescription (Rx) program, supported by in-person coaching and innovative health~     technologies. The program improves the health of Canadians and reduces their risk for~     chronic disease by tackling three major risk factors that are shared across a number of~     chronic diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS~     participant receives an individualized healthy living Rx for exercise, physical activity~     (step counts) and healthy eating, supported by coaching and technology tools to promote~     long-term health behaviour change. For this study, the investigators will undertake a~     6-month pilot pragmatic randomized controlled trial (RCT), conducted within 5 clinic~     settings in Southwestern Ontario. The primary aim is to conduct an outcome evaluation to~     determine the effectiveness of the HeS program in helping at-risk individuals increase~     physical activity levels, improve eating habits, and improve other health behaviours and~     health indicators.~   "
49180|NCT02413372|"~     The purpose of this study is to determine whether BMS-986036 is effective in the treatment~     of subjects with Non-alcoholic Steatohepatitis (NASH).~   "
49181|NCT02413359|"~     The patients with complications of COPD and asthma have features mixed with two diseases,~     COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have~     symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating~     the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to~     clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main~     secondary objectives are To explore the features of history of COPD exacerbations, symptoms,~     eosinophilic inflammation and patient background in patients with ACOS, to clarify the~     history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic~     inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in~     patients with COPD. This is a cross-sectional study targeting COPD patients receiving~     outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and~     DBL would be locked by 3Q 2015.~   "
49182|NCT02413346|"~     Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral~     sarecycline in the long-term treatment of subjects with moderate to severe facial acne~     vulgaris.~   "
49183|NCT02413333|"~     The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean~     residual peroxide in used lens cases collected at Day 30 after neutralization at recommended~     storage time.~   "
49184|NCT02413320|"~     Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of~     breast cancer cells in women with Stage I, II, or III triple negative breast cancer.~   "
49216|NCT02412904|"~     rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF.~     However, there is a debate in the literature which one is better to induce ovulation in~     patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.~      The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences~     among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.~   "
49185|NCT02413307|"~     **PLEASE NOTE** this study is currently open only to clients on the waiting list at the~     Centre for Trauma Resilience and Growth, UK.~      The project will involve adapting and implementing a five minute daily self-practice~     compassion-focused intervention and evaluate its impact on psychological and physiological~     factors associated with trauma. It aims to offer a novel intervention which may facilitate~     further benefits from trauma specific therapy. This would be a unique use of self-practice~     Compassion Focused Therapy (CFT) specifically for trauma clients. Previous research has~     found that many factors can impact on client's benefitting from therapy, including~     depression, anxiety and self-criticism. These things also get in the way of being~     compassionate towards oneself, and this can be a difficulty for people who have experienced~     traumatic events. Service users have identified that additional support before trauma~     specific therapy can be useful and this may offer a positive use of time whilst on therapy~     waiting lists.~      Hypotheses:~      i. A brief CFT intervention will decrease levels of depression, anxiety, stress and increase~     baseline Heart Rate Variability.~      ii. The compassion focused intervention will increase experiences of self-compassion, social~     safeness, and reduce levels of self-criticism.~      iii. High 'fear of compassion' will moderate the impact of the intervention and result in~     smaller changes in depression, anxiety, stress and post traumatic change.~      Clients of the Centre for trauma, resilience and growth will be approached to participate in~     the study. All participants will have experienced trauma for which they are seeking~     psychological support. The current compassion focused intervention will be offered to~     participants on the waiting list for trauma specific therapy at the trauma centre. Each~     participant will be asked to practice the intervention in their own time over a period of~     three weeks. There will be initial assessments, repeated assessments following the~     intervention, and repeated assessments pre and post trauma specific therapies engaged in.~   "
49186|NCT02413294|"~     The investigators are aiming to examine the acceptability and feasibility of a portable~     bright light therapy instrument to improve sleep disturbance in a preventive intervention~     for depression. The investigators will conduct an intervention that trials the use of bright~     light glasses called re-timers as a preventive intervention in older adults with sleep~     disturbance and subsyndromal symptoms of depression.~   "
49187|NCT02413281|"~     This study will evaluate the abuse potential of ALKS 5461.~   "
49188|NCT02413268|"~     A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial~     artery occlusion after transradial catheterization.~   "
49189|NCT02413255|"~     The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics~     of ascending single- and multiple-doses of TAK-020 in healthy participants.~   "
49190|NCT02413242|"~     Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is~     a frequently occurring health-care associated infection, which causes considerable~     morbidity, mortality and health care costs. Important pathogens causing ICU pneumonia are~     Staphylococcus aureus and Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and~     patient-related and contextual factors is not fully described, but is urgently needed to~     support the development of effective interventions.~   "
49191|NCT02413229|"~     The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and~     a Placebo in patients with moderate to severe scalp psoriasis.~   "
49192|NCT02413216|"~     Tic Disorders (including Tourette Disorder) are relatively common in school-age children and~     for some children can lead to significant psychosocial and physical impairment and~     diminished quality of life. Non-pharmacological treatments have been shown to be effective~     for reducing tics in some children. These treatment options are desired by parents, but are~     not widely available. The investigators recently developed an online, computerized,~     self-administered version of CBIT called TicHelper.com. The current study will test the~     efficacy of TicHelper.com in a randomized clinical trial.~   "
49193|NCT02413203|"~     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated~     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.~     Global deletion of mPGES-1 in mice suppresses PGE2 and augments PGI2 by PGH2 substrate~     rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a~     predisposition to thrombogenesis and hypertension. However, cell-specific deletion of~     mPGES-1 reveals that the predominant substrate rediversion product amongst the~     prostaglandins varies by cell type, complicating drug development. The research team has~     developed an ultra performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS)~     technique that allows the quantification of a wide range of lipids beyond the prostaglandin~     pathway (leukotrienes, anandamide and the 2-arachidonylglycerol cascades).~      This study is designed to examine different pathway interventions from the arachidonic acid~     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human~     blood in vitro (Part A) and ex vivo (Part B). In Part B, healthy volunteers will be asked to~     take a single, therapeutic dose of celecoxib and blood and urine samples will be collected~     before and after drug administration. Collected blood will be stimulated ex vivo, and lipids~     and their metabolites will be measured in blood and urine, respectively. The investigators~     expect that lipid profile from ex vivo hWBA done on celecoxib-treated subjects will~     recapitulate findings from the in vitro hWBA received with celecoxib-treated human blood~     (Part A).~   "
49194|NCT02413190|"~     This is a cross-sectional single visit study to determine bone health in individuals with~     FSHD.~   "
49195|NCT02413177|"~     The overall goal of the proposed study is to develop and test real time neurofeedback~     (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is~     based on the theoretical model that (1) mind-wandering and self-referential processing are~     associated with stress, (2) meditation redirects the wandering mind toward present-centered~     awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN)~     involved in mind-wandering and self-referential processing, and thus (4) meditation leading~     to decreased activity in these hubs should lead to reduced stress and improved health and~     well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation~     augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to~     real-world outcomes in reduced stress and improved attention.~   "
49196|NCT02413164|"~     The aim of the investigators' study would evaluate the effectiveness of a multimodal~     exercise program on health related quality of life, symptoms and cardiometabolic parameters~     in patients with schizophrenia.~      DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who~     receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive~     statistics, measuring central tendency and dispersion of the variables study. Inferential~     statistics will be made between intervention of key variables and outcome.~   "
49230|NCT02412722|"~     The purposes of this study are to: evaluate the safety and tolerability of MLN0128 milled~     active pharmaceutical ingredient (API) capsules administered both as a single agent and in~     combination with paclitaxel, to characterize the effect of a high-fat meal on the~     pharmacokinetics (PK) of MLN0128 milled API capsules, and to characterize the PK of MLN0128~     milled API capsules when administered on an empty stomach approximately 24 hours after~     paclitaxel infusion.~   "
49197|NCT02413151|"~     Cardiac resynchronization therapy(CRT) is recommended to reduce mortality and morbidity in~     chronic heart failure(CHF) patients New York Heart Association(NYHA) class III-IV who are~     symptomatic despite optimal medical therapy, with a reduced left ventricular(LV) ejection~     fraction(LVEF) and prolonged complex QRS. CRT improves the prognosis however, despite the~     improvement, all major trials have demonstrated that one third of the patients are~     non-responders to CRT. Three months after the CRT implant, the responders have a significant~     increase in endothelial function(EntF), a decrease in the LV end-systolic volume, and~     increase in LVEF, 6 minute walk test(6MWT), improvements in NYHA class and quality of life.~     It is currently unknown if adding an exercise training(ExT) program following CRT provides~     better clinical outcomes than CRT alone. Prior studies on CRT and ExT have been preliminary~     in nature, but suggest small improvements in functional capacity(FC). The correction of~     endothelial dysfunction is associated with a significant improvement in exercise capacity~     evidenced by a 26%increase in peak oxygen uptake. These findings are important because CHF~     patients with the greatest sympathetic activation and the most reduced EntF have the poorest~     prognosis. Our experience with coronary artery disease patients, and most recently data in~     patients with CHF show that an ExT program that combines aerobic exercise(AE) and resistance~     exercise training are more effective than an AE program alone, and the aerobic interval~     training showed better improvements than continuous endurance training. It is unknown how~     CHF with more severe functional limitations responds to ExT and, more important, the~     explanation of the physiological mechanism that can explain the improvements as a~     consequence of ExT. This lack of scientific information is urgent since this is the group of~     patients that normally is targeted for CRT. The investigators propose to use a stratified~     randomized longitudinal study to determine the additional effects of a 6 month ExT in~     addition to CRT in NYHA stage III-IV HF patients. The aims of the study are:1-to determine~     whether a long-term ExT program follow the CRT provides better clinical outcomes than CRT~     alone and 2-To identify the mechanisms of the hypothesize improvement. The results of this~     project will represent an important contribution by understanding the role of ExT after CRT~     NYHA stage III-IV heart failure(HF) patients, an understudied population with poor clinical~     outcome. Understanding the potential mechanisms associated with clinical improvement and~     outcome is essential for the rehabilitative process to develop new innovative therapies in~     this high risk population. The investigators will use state-of-art methods including an~     integrated assessment autonomic nervous system(ANS) and arterial function using 123I-MIBG~     scintigraphy.~   "
49198|NCT02413138|"~     The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of~     somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy~     stage. Upon completion of the PK/PD stage, the PK/PD profiles for the GHD children in this~     study will be compared to the PK/PD profiles for the GHD children treated in the Western~     study Phase 1b/2a study (Protocol 12VR2) and identify the somavaratan dose to be used in the~     Phase 3 stage in Japan. The Phase 3 stage will continue dosing for 12 months to obtain~     safety and efficacy data on 48 subjects.~   "
49199|NCT02413125|"~     Rhinosinusitis is one of the most prevalent diseases within the United States and leads to~     decreased quality of life for patients suffering from this condition. A foundation in~     treatment for rhinosinusitis is nasal saline irrigations, which are administered through an~     irrigation bottle. The irrigation bottles are prone to contamination by bacterial and fungal~     species despite proper maintenance.~      A new commercially available irrigation solution has been created using chitosan, a natural~     polysaccharide with antibacterial and antifungal properties. This research project will~     examine the ability of chitosan to decrease or prevent contamination of irrigation bottles~     after 1 month use by adult patients with rhinosinusitis.~      Participants in this project will use either saline or chitosan irrigation solution for 1~     month and then switch to the other solution for 1 month. Following 1 month of use, the~     irrigation bottles will be cultured to determine if chitosan irrigation solution decreased~     the contamination of the irrigation bottles.~   "
49200|NCT02413112|"~     It is well accepted that physical activity in the form of resistance training produces a~     wide variety of neuromuscular-skeletal and health benefits. It is recommended in Finland~     that older individuals (over 65yr) should perform resistance training twice per week.~      Unfortunately, only approx. 5% of older individuals fulfill this recommendation. As Finnish~     society grows ever older, research should focus on the specific needs of this group and how~     to improve participation in physical activity, which may ultimately lead to modification of~     physical activity recommendations - resistance training recommendations are currently the~     same for young and older adults and do not include specific recommendations on the type of~     resistance training. However, these recommendations appear to have been developed for best~     possible improvements in maximum strength and muscle size.~      Therefore, it is of great importance to identify the number of resistance training sessions~     per week required to induce improvements in physical fitness, metabolic and bone health~     status, and importantly the reasons for adherence to/drop-out of resistance training~     interventions (e.g. motivation to train) in a multi-discipline study. This knowledge would~     benefit policy makers to update current recommendations for resistance training and to~     devise strategies to advise realistic targets for resistance training in the older,~     particularly the less-educated, age group (e.g. TELI-strategy for 2020).~      The present study will include a 12-month resistance training intervention with a 12-month~     follow-up period. Interviews and questionnaires will assess psychological/sociological data~     and will be collected from both drop-out subjects and those that complete the intervention.~     Neuromuscular performance and functional capacity will be tested using conventional methods,~     along with body composition, bone density, and blood tests for metabolic markers of health.~     Diet and other physical activity will be controlled throughout the intervention period.~     Measurements are to be performed every 3 months.~      It is expected that 5 international peer-reviewed articles will be published in 2016-2017.~     The data will be presented at international and national conferences in 2015-2017. Finally,~     results of the entire research will be published in national peer-reviewed journals (e.g.~     The Age Institute's Raportteja). All subjects will be invited to attend an information~     meeting where group results will be presented and explained.~   "
49201|NCT02413099|"~     Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra,~     Dioscorea tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna~     Linn, Honey, improved the erectile function by preserving the smooth muscle content and~     inhibiting the fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this~     study, the researchers investigated the efficacy and safety of the herbal formula (KBMSI-2)~     in the treatment of ED.~      Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g~     or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy~     variable was the change in the EF domain scores of the IIEF questionnaire from baseline.~     Secondary efficacy measures included change in all domain scores of the IIEF from baseline,~     change in question 2 and 3 of the SEP2,3, from baseline.~   "
49202|NCT02413086|"~     Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors~     leading to limb amputation, it was reported that the amputation rate is 15 times of the~     non-diabetic patients. Common surgical amputation is not only about high plane amputation~     but also bring a tremendous mental stress to patients which may affect the quality of life~     seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia ,~     and septic shock which could be the main cause of death before amputation. It become an~     important topic that how to control the infection, reduce the amputation plane, save the~     function as possibility, and improve the life quality of the patients as well.~      This study is based on years of clinical experience of and brings out early-stage~     amputation concept firstly in China with a systematic exposition, experimental research and~     clinical research. Early-stage amputation refers to cut in the normal tissue from the~     inflammatory tissue at the junction line of limbs, in order to achieve more retained stump,~     block endotoxin absorption and improve the quality of life of patients. External therapy of~     herbs chitosan can promote granulation tissue regeneration and control of local infection,~     it solved the problem of difficult wound healing and it is a reliable guarantee of~     early-stage amputation.~   "
49203|NCT02413073|"~     There are no studies in the literature evaluating the vibration of the whole body in~     patients with chronic renal failure. The study aims to assess the effectiveness of whole~     body vibration in patients with renal disease in the final phase in the interdialytic~     period. It will be a randomized, triple-blind, controlled and randomized. The pilot study~     will be 20 individuals initially. In intervention patients will be randomly divided into two~     groups: sham platform and platform. As a result it is expected that the training of whole~     body vibration may promote patient compliance, since it requires less physical effort for~     implementation and greater comfort in the application, thus allowing the sedentary and / or~     less active patients can benefit by to minimize the harmful effects of physical inactivity~     associated with pre-existing kidney problems.~   "
49204|NCT02413060|"~     The purpose of this study is to determine whether the long-term effects of high-intensity~     progressive resistance training could improve glucose and lipid metabolism in chinese type 2~     diabetes.~   "
49205|NCT02413047|"~     The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory~     bowel disease (IBD) is an important cause of loss of response to therapy that may lead to~     escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI)~     or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of~     response. An alternative approach is the addition of immunomodulator (IM) therapy to~     counteract the antibody response and regain efficacy of the biologic medication. The~     investigators' goal is to treat patients' who have lost response to adalimumab or infliximab~     with an immunomodulator with the goal of eliminating the circulating antibodies to the~     anti-TNF and restoring efficacy.~   "
49206|NCT02413034|"~     Total joint replacement is a common clinical practice for patients suffering from disabling~     arthritis, since it provides significant pain relief and functional recovering.~     Nevertheless, its outcome is compromised by complications such as periprosthetic joint~     infection (PJI), which is reported to occur in 1 to 4% of primary total knee arthroplasties~     (TKA), and approximately 1% of primary total hip replacements (THR). Despite all efforts to~     restrain PJI, its prevalence may reach even higher proportions if patients undergo a~     resection arthroplasty or irrigation and débridement for infected prosthesis. That said,~     timely diagnosis and early isolation of the infected microorganism is utterly important, if~     proper care is to be delivered.~      The gold standard for the diagnosis of PJI is the isolation of a microorganism from the~     intraoperative cultures, combined with the sonication from retrieved joint implants1. This~     technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias~     to the bone cement, which has been proved to be a more sensitive method than conventional~     intraoperative cultures. False-negative percentages were reported to be 15% in patients who~     did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was~     administered.~      Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an~     organism is not always successfully isolated from the intraoperative cultures, which~     increases false negatives results. This fact has been trying to be explained by several~     authors, some of which postulate that antibiotic prophylaxis could interfere with the~     isolation of the microorganism from the intraoperative cultures. As a result, and acting~     accordingly to this hypothesis, preoperative antibiotics are often withheld until~     intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics.~     Nevertheless, one should be aware of the adverse consequences of this practice that may~     result in systemic dissemination of infection.~      Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not~     interfere with the isolation of the microorganism from intraoperative cultures, despite~     being studies that lack statistical power.~      Therefore, it is clear that reported studies in this field support both preoperative~     antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures~     are obtained.~      This decision in the department study depends exclusively on the treating surgeon judgment.~     In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative~     antibiotic prophylaxis, which could be related to higher false-negative intraoperative~     culture and sonication results. Thus, the investigators add substances with chelation~     properties to hemoculture containers and then inoculate sonication samples. This practice~     offsets antibiotic interference with intraoperative cultures and has proved to enhance~     microorganism detection rates.~      That said, and given the lack of scientific evidence about this clinical practice the~     investigators are willing to engage a prospective randomized double-blind clinical trial,~     that will allow us to determine whether intraoperative cultures and sonication samples are~     affected by antibiotic prophylaxis.~   "
49207|NCT02413021|"~     The purpose of this study is to determine whether deferasirox is effective in the treatment~     of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).~   "
49208|NCT02413008|"~     This is a phase II, prospective, randomized, double-blind, placebo-controlled, international~     (Spain and Sweden) and multicentre study.~      In the setting of postmenopausal hormone receptor positive breast cancer, treatment with~     aromatase inhibitors (AIs) is the most effective and well-studied therapy. Vaginal dryness~     is one of the most frequently reported symptom caused by this adjuvant therapy which may~     lead to a reduced adherence in breast cancer women.~      This study will explore the safety of 0.005% estriol vaginal gel in this oncological~     context, to demonstrate that this medicinal product is a safe option to treat the vaginal~     atrophy caused by AIs, without a clinically relevant influence in gonadotropins or systemic~     estrogen levels.~      The main objective is to evaluate the levels of Follicle Stimulating Hormone (FSH) after~     treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women~     with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs)~     in the adjuvant setting and symptoms of vaginal atrophy.~   "
49209|NCT02412995|"~     The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as~     well as on metabolic profiles were examined in overweight or obese male subjects. The study~     was conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen~     subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test~     meals contained either sea buckthorn, strawberry or no berries and added sucrose to match~     with respect to sucrose content. Blood samples were collected at baseline and several times~     postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min~     until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also~     collected at baseline and at several time intervals until 24 hours. Blood and urine were~     subjected to metabolic profiling to investigate potential biomarkers of berry intake.~   "
49210|NCT02412982|"~     This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ~     between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed~     on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare~     two enoxaparin dosing strategies.~   "
49211|NCT02412969|"~     This study is to examine the onset of pain relief with two different methods of labor~     epidural. The traditional labor epidural involves the placement of numbing and anti-pain~     medicine in the epidural space which surrounds the spinal cord. In order to take effect, the~     medication has to cross a layer of tissue called the dura. In the current study, the same~     medications are placed in the epidural space after the dura is punctured with a fine needle.~     This research, will help evaluate whether this technique will result in earlier onset of~     pain relief.~   "
49212|NCT02412956|"~     Despite the great health benefits associated with smoking cessation in pregnancy to both~     mother and baby, few studies to date have examined the applications of text messaging or~     other communication technologies for smoking cessation in this population. This project is~     the first step in developing a new dissemination strategy for reaching pregnant smokers.~     This research will explore how a state-of -the-art, interactive and intensive, text~     messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers.~     This program may have the potential to reach pregnant smokers who are not currently being~     reached with traditional smoking cessation services. The study Aims are: 1) to elicit~     qualitative feedback from pregnant smokers and recent quitters (in the past month) about the~     concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed~     messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of~     SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To~     conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent~     quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes~     will join an SMS program by responding to different types of recruitment messages.~   "
49213|NCT02412943|"~     This study evaluates the transfusion of fresh frozen plasma containing the enzyme PAPP-A2~     into the a female adult. This female adult has a mutated version of PAPP-A2 that prevents~     the unbinding of IGF-1 from IGF binding proteins. The investigator's hypothesize that~     transfusion of plasma with donor PAPP-A2 will lead to the unbinding of IGF-1 from its~     binding proteins and that they will be able to measure free IGF-1 in the blood of this~     female adult.~   "
49214|NCT02412930|"~     Paravertebral block has been widely used for analgesia. The aim of this study,comparison of~     the effect of ultrasound-guided paravertebral block versus intravenous tramadol for~     postoperative pain control in percutaneous nephrolithotomy.~   "
49264|NCT02412280|"~     Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver~     transplantation.~   "
49217|NCT02412891|"~     Evaluation of UroShield device impact upon side effects and complications of urinary~     catheter usage.~      The use of urinary catheters is a common medical practice in the perioperative setting.~      As such, it exposes the patient to certain comorbidities, including urinary tract~     infections.~      The infectious process is known to begin with a development of a biofilm on the catheter's~     surface. This fact makes it an attractive target for UTI prevention technology.~      Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the~     efficacy of this method in vivo.~   "
49218|NCT02412878|"~     The purpose of the study is to compare once-weekly carfilzomib dosing in combination with~     dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in~     subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib~     and an immunomodulatory agent (IMiD).~   "
49219|NCT02412865|"~     The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program~     to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.~      In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers~     who have been recruited from users of text4baby - the first large scale mobile health~     application in the United States. Developed and operated by Voxiva and Healthy Mothers,~     Healthy Babies (HMHB)—collaborators in this program -text4baby is a free national service~     that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and~     delivered more than 150 million health messages to them including messages encouraging them~     not to smoke during pregnancy and referring them to quit lines.~      Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher~     levels of knowledge about the dangers of second hand smoke and the benefits of smoking~     cessation for mothers and their infants than text4baby only users.~      Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly~     higher rates of calling a quit line, discussions with their health provider and/or use of~     cessation counseling than those who receive Text4baby alone.~      Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly~     more favorable quitting outcomes compared with text4baby alone.~   "
49220|NCT02412852|"~     In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks~     with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.~     Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications~     affects on pain following treatment will also be recorded.~   "
49221|NCT02412839|"~     This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39~     (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males~     and 15 females). The sublingual microcirculation will be examined with the incident dark~     field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims~     to compare the differences of microcirculation among the three groups and between genders.~   "
49222|NCT02412826|"~     The purpose of this study is to conduct a pilot test of an abdominal acoustic sensor on~     patients with acute pancreatitis to determine the correlation of acoustic signals with~     symptoms reported by the patient.~   "
49223|NCT02412813|"~     This is a prospective, randomized, multi-center, metal hypersensitivity study comparing~     OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty~     (TKA).~   "
49224|NCT02412800|"~     Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation~     is not uncommon. Injury may occur because liver transplantation is often associated with~     prolonged operative time, large volumes of fluid administration and transfusion, as well as~     inflammatory responses related to ischemia-reperfusion injury. For more precise~     perioperative fluid and hemodynamic management, modern monitoring systems, such as the pulse~     contour cardiac output (PiCCO) system, have been devised and reported in recent years. The~     PiCCO system uses the thermodilution technique to determine the cardiac index (CI) and~     thoracic fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular~     lung water index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may~     reflect pulmonary fluid and injury status. However, perioperative changes in thoracic fluid~     indices in liver transplantation and their associations with postoperative ALI are not yet~     clear. In this study, the investigators aimed to determine patterns of change in~     perioperative thoracic fluid indices and compare these changes in recipients who did or did~     not develop postoperative ALI. Furthermore, the investigators will also try to determine the~     potential risk factors following liver transplantation.~   "
49225|NCT02412787|"~     This extension study will allow participants that completed Study HGT-HIT-094 to continue~     receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving~     Elaprase treatment and begin concurrent IT treatment for those that did not received~     idursulfase IT treatment in Study HGT-HIT-094.~   "
49226|NCT02412774|"~     The purpose of the present study is to evaluate the effect of replacing diet beverages with~     water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic~     risk factors of diabetic obese and overweight female adults when they are in a~     multidisciplinary weight loss plan.~   "
49227|NCT02412761|"~     Children are increasingly being diagnosed with essential hypertension and the absence of~     comparative effectiveness research in antihypertensive therapies has contributed to~     considerable differences in prescribing practices among physicians treating children with~     essential hypertension.~      This study will consist of a series of systematically-administered n-of-1 trials among~     children to verify the need for ongoing antihypertensive treatment and if so, to identify~     the preferred single drug therapy.~   "
49228|NCT02412748|"~     The number of children living apart from their fathers has grown nationally, and the~     greatest percentage is evident among African American (AA) families; two-thirds of all~     African American children live in households without their biological father. Research~     supports the importance of positive fathering in the lives of children. But in order for~     children to benefit from their fathers' involvement, the father-child relationship must be~     timely and sustained. This study will test culturally relevant interventions aimed at~     increasing non-resident (not living with the child) AA fathers' involvement with their~     children.~   "
49229|NCT02412735|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3~     study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or~     combined with hyaluronic acid (HA) in subjects with chronic low back pain (> 6 months)~     associated with moderate radiographic degenerative changes of a disc~   "
49231|NCT02412709|"~     The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to~     detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in~     Phase I of this project.~      In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns~     and to obtain prevalence data on LQTS in California.~      The 4 main objectives are:~        1. To validate the capacity of QTScreen for LQTS screening in newborns.~        2. To determine the extent to which parents are able to use QTScreen on their babies at~          home.~        3. To survey end-user experience and opinions.~        4. To estimate the LQTS prevalence in California.~   "
49232|NCT02412696|"~     This study is testing the hypothesis of whether continuous positive airway pressure (CPAP)~     therapy improves placental histopathology and secretory function. The main aims of the study~     are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both~     common highly morbid conditions.~   "
49233|NCT02412683|"~     Subgroups of patients with radically operated colorectal cancer can have a better prognosis~     by over six months are treated with chemotherapy. This beneficial effect may be enhanced~     somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is~     known that this treatment additions increase the risk of neurotoxic side effects such as~     sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste~     disorders and swallowing difficulties.~      The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant~     chemotherapy experience neurotoxic effects and if the experience of the symptoms change over~     time during treatment and how symptoms affect patients' daily lives and quality of life.~   "
49234|NCT02412670|"~     This phase II trial studies how well giving chemotherapy before surgery works in treating~     patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as~     methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride,~     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Removing the~     affected upper urinary tract by surgery is the recommended treatment for upper urinary tract~     cancer, but can cause loss of kidney function and prevent patients from being able to~     receive chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are~     working at their maximum, may allow less tissue to be removed during surgery and may be more~     effective in treating patients with high grade upper urinary tract cancer.~   "
49235|NCT02412657|"~     Interscalene brachial plexus block provides excellent but time limited analgesia.~     Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene~     block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of~     two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic~     duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4~     mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a~     single-shot interscalene block with ropivacaine.~   "
49236|NCT02412644|"~     12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla®~     (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy~   "
49237|NCT02412631|"~     Some individuals smoke with the perception that smoking helps control body weight. Smokers~     gain an average of as much as 10 pounds in the months following smoking abstinence, with~     heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research~     Program will randomize 100 nondiabetic, overweight or obese adult smokers to active~     lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline~     for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of~     lorcaserin for decreasing weight gain after stopping smoking.~   "
49238|NCT02412618|"~     A randomized double--‐blinded comparison of same--‐day mifepristone and misoprostol with~     misoprostol only for cervical preparation in second--‐trimester surgical abortion in 100~     women at 14 0/7--‐19 6/7 weeks gestation.~   "
49239|NCT02412605|"~     Records of women who had trophectoderm biopsy for sex selection over the last 3 years will~     be reviewed and its outcome will be compared to other records of women who had IVF/ICSI~     without embryo biopsy.~   "
49240|NCT02412592|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the~     satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients.~     However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur~     in some patients who achieved HBeAg seronconversion by interferon treatment. In this study,~     the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg~     seronconversion after interferon treatment and the factors associated with viral and~     clinical relapse will be observed.~   "
49241|NCT02412579|"~     The purpose of this study is to determine whether genetic markers unique to liver cancer are~     present and to assess usefulness as a diagnostic tool.~   "
49242|NCT02412566|"~     While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition~     (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early~     PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the~     calories that are lost from this relative decreased dose of lipids can be provided by~     adjusting the dextrose content of the PN solution and providing a higher glucose infusion~     rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is~     inadequate. Inadequate growth is a direct cause of poor outcomes including poorer~     neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of~     their often already damaged intestine. These outcomes can lead to severe disability and~     death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing~     must have a greater intake of lipids to meet their needs for weight, length, and head~     circumference growth.~      SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid~     sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated~     fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty~     acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain~     triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in~     what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being~     limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids.~     Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of~     the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty~     acid requirements. Its use in situations in which growth is inadequate in babies who must be~     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly~     increase their chances of both a good neurological outcome and survival.~      Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help~     promote good growth while reducing the severity (or seriousness) of liver disease or help~     put an end to liver disease in infants.~   "
49301|NCT02411799|"~     Establish a data repository of patients who have undergone thoracic and/or lumbar~     instrumented arthrodesis procedure supplemented by the Implanet Jazz System.~   "
49243|NCT02412553|"~     The study is proposed as a 2-year single site, open-label clinical trial of enteral~     nutrition or the specific carbohydrate diet in patients with active CD or UC. Patients~     seeking care in the outpatient clinics of the Division of Gastroenterology at Massachusetts~     General Hospital will be approached for participation in the trial during their routine~     outpatient appointments. All patients are required to have a diagnosis of CD or UC confirmed~     using standard clinical, endoscopic, and histologic criteria. Eligible patients will~     complete an office visit to confirm eligibility for the study and informed consent will be~     obtained. They will then be scheduled for a routine colonoscopy as part of their standard~     clinical care to objectively confirm active disease and obtain biopsies for microbiome and~     gene expression. The investigators will obtain prior authorization from the subject's~     insurance company for such colonoscopy, or if it is not covered by the insurance, the~     investigators will use study funds to pay for the procedure. They will then be assigned to~     one of two dietary intervention arms based on their preference and will meet with the study~     registered dietician at the MGH Clinical Research Center (CRC) metabolism and nutrition~     unit. There, they will receive instruction on the components of the assigned dietary therapy~     arm - partial elemental diet (enteral nutrition) or specific carbohydrate diet, and will~     complete a baseline food record (FR). They will adhere to the dietary therapy for 6 weeks~     after which they can resume normal diet. Clinical, biochemical, nutritional, and~     microbiological parameters will be measured during and for 6 weeks following the study. They~     will have 5 study visits during this time.~   "
49244|NCT02412540|"~     The goal of this study is to determine effective treatment and identify diagnostic~     biomarkers for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study~     will be participating in either a weight loss surgery (WLS) group or a comprehensive~     lifestyle intervention (CLI) group. People in the WLS group will receive vertical sleeve~     gastrectomy (VSG). The CLI group will receive dietary, activity and behavioral interventions~     provided by trained study staff.~   "
49245|NCT02412527|"~     Objective: Computerized sleep staging has been verified in a normal population. This study~     attempts to investigate and verify the interpretation of this computerized sleep staging~     program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm~     for sleep duration and postures.~        1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality~          indicators: through actigraphy and heart rate sensors, compare the computerized~          sleep-wake analysis program with polysomnography, and verify its clinical reliability~          and validity in sleep disorder patients.~        2. Establish the sleep posture detection system: through three-axis accelerometer, develop~          algorithms for position recording and monitoring during sleep, and upgrade its accuracy~          according to photography.~      Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in~     sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine~     polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as~     well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor~     patch will be used for sleep posture detection and further computerized sleep-wake analysis.~     Results will be verified the consistency by comparison with sleep-wake analysis from~     polysomnographic data and sleep-related questionnaires.~   "
49246|NCT02412514|"~     This is a phase IV open-label randomized clinical trial that will compare intestinal and~     humoral immunity in infants receiving inactivated poliovirus vaccine (IPV) and two or three~     doses of bivalent oral poliovirus vaccine (bOPV).~   "
49247|NCT02412501|"~     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx~     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native~     coronary arteries that allows the use of a 2.0 mm diameter stent.~   "
49248|NCT02412488|"~     The purpose of the RIO 2 International study is to provide clinical and economic evidence to~     support moving the LINQ™ insertion procedure outside these traditional locations within the~     hospital, referred to as out-of-cathlab.~   "
49249|NCT02412475|"~     Successful treatment for children and young adults with relapsed acute myeloid leukemia~     (AML) continues to be a significant challenge. Despite relative improvements in survival for~     patients with newly diagnosed AML, an estimated 40-60% will relapse with the majority~     eventually dying of their relapsed disease. Attaining a subsequent remission in patients who~     relapse is the initial critical step toward achieving a potential cure. As chemotherapy~     resistance is one of the primary drivers of poor treatment response and subsequent relapse~     in AML, identifying methods to reverse this resistance are desperately needed. This clinical~     trial is aimed at improving the remission re-Induction rates for children and adults with~     relapsed or refractory AML through epigenetic modifying agents that have the ability to~     reverse chemotherapy resistance. Decitabine, a DNA methyltransferase inhibitor (DNMTi) and~     Vorinostat, a histone deacetylase inhibitor (HDACi), are two epigenetic modifying drugs that~     act on the methylation of proximal promoter regions of genes and on proteins involved in the~     wrapping of DNA around histones, respectively. Both processes play a critical role in~     regulating gene expression, and frequently these genes are involved in chemotherapy~     resistance. These agents are FDA-approved for treatment in adult hematologic malignancies,~     making this an opportune time to begin testing these novel therapies in pediatric leukemia~     trials. This study will investigate chemotherapy priming of relapsed/refractory AML using~     Decitabine and Vorinostat given for 5 days prior to standard re-Induction with Fludarabine,~     Cytarabine and G-CSF for children and adults.~   "
49250|NCT02412462|"~     This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and~     pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a~     humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin~     (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible~     subjects will have a disease that has been refractory to prior therapy and is unlikely to~     benefit from known therapies.~   "
49251|NCT02412449|"~     The primary purpose of this study is to compare the PK parameters of a single dose of a test~     tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet~     formulation, both treatments administered without food, and to compare the PK parameters of~     the test tablet formulation given under fed and fasted conditions.~   "
49302|NCT02411786|"~     The purpose of this study is to determine if a vaccine called pTVG-AR can enhance patients'~     immune response against prostate cancer.~   "
49252|NCT02412436|"~     This study is being done to evaluate the effect of HIV and TB treatment on a commonly used~     birth control method. This study is being done on women who are infected with HIV and TB and~     are taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB~     medication) and isoniazid (INH; an anti-TB medication). The purpose of this study is to find~     out the best schedule to give depot medroxyprogesterone acetate (DMPA; a hormonal birth~     control method that is given as a shot every 3 months) in women with HIV and TB who are also~     taking EFV and RIF. This study will also try to find out if a 150 mg injection of DMPA is~     effective in preventing ovulation, the process by which the ovaries (the ovaries are part of~     the female reproductive system) release an egg for fertilization, for 12 weeks in women who~     are taking EFV and RIF. Another purpose of this study is to find out if it is safe to take~     RIF, EFV and DMPA at the same time.~   "
49253|NCT02412423|"~     In beijing model for haploidentical transplant, the rate of acute graft-versus-host~     disease (GVHD) from maternal or collateral donors was significantly higher than that from~     other kins. To reduce the GVHD incidence from maternal or collateral donors,~     post-transplantation cyclophosphamide is planned to be added into the protocol in beijing~     model.~   "
49254|NCT02412410|"~     This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive~     efficacy of laborists involved in shift work at Mayo Clinic Rochester.~   "
49255|NCT02412397|"~     To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite~     Shoulder System~   "
49256|NCT02412384|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     lung cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of lung cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
49257|NCT02412371|"~     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in~     combination with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy (Phase 1 portion)~     and to assess whether the addition of oral veliparib versus placebo to~     Paclitaxel/Carboplatin-based chemoradiotherapy with Paclitaxel/Carboplatin consolidation~     will improve progression-free survival (PFS) in subjects with Stage III non-small cell lung~     cancer (Phase 2 portion).~   "
49258|NCT02412358|"~     -  Objective: To compare clinical results of three types of manual tooth brushes on~          gingivitis and plaque removal efficacy.~        -  Material and Methods: This study is a single blind randomized trial with crossover~          design which involved 30 periodontally healthy individuals. At baseline professional~          plaque removal and oral hygiene instruction are performed for all the students, then~          they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores~          are measured using plaque and gingival indices (PI and GI). Then subjects are~          instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices~          are assessed again. After passing one-week period for wash out, subjects don't brush~          for 1-2 days and indices are recorded again. The same procedure are done for Cross~          action, and Butler 411 tooth brushes respectively.~   "
49259|NCT02412345|"~     The primary objective of this study is to determine the impact of the shock wave application~     in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives~     are to assess the effects of therapy on quality of life and depression.~      It is expected that with the study is defined the usefulness of the therapy and the~     dissemination of knowledge generated for change in clinical management in renal transplant~     patients with erectile dysfunction.~   "
49260|NCT02412332|"~     The purpose of this study is to determine whether cell therapy with autologous adult stem~     cells (from bone marrow and/or fat) is safe in the treatment of advanced Chronic Obstructive~     Pulmonary Disease (COPD).~   "
49261|NCT02412319|"~     Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in~     the treatment of HBeAg positive chronic hepatitis B.~   "
49262|NCT02412306|"~     Open-label combined two-part multi-center clinical study to evaluate the efficacy, safety,~     and tolerabillity of blinatumomab in adult and pediatric Japanese subjects with R/R~     B-precursor ALL.~      The Phase 1b part will investigate the safety, efficacy, PK and PD of blinatumomab in adult~     Japanse subects with R/R B-precursor ALL to determine the MTD (maximum tolerated dose) in~     both adult and pediatric subjects. Once a dose has been selected in the Phase 1b part, the~     Phase 2 part will assess the safety and efficacy of the recommeded dose level of~     blinatumomab identified in the Phase 1b portion of the study in the adult study population.~   "
49263|NCT02412293|"~     There is limited evidence from community-based interventions to guide the development of~     effective maternal, perinatal and newborn care practices and services in developing~     countries. Investigators planned to evaluate the impact of a low-cost package of~     community-based interventions implemented through government sector lady health workers~     (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on~     perinatal and neonatal outcomes in a sub-population of the remote mountainous district of~     Gilgit, Northern Pakistan.~      A community-based package for use by LHWs and CHWs geared towards prevention and promotion~     of maternal and newborn health practices and services will be developed based on formative~     research in the study district. The package will include promotion of antenatal care,~     adequate nutrition, skilled delivery and healthy newborn care practices at household level.~     The health workers will be trained in recognition of danger sign that warrant referral to~     health care service. LHWs and CHWs will delivered the package via community awareness~     sessions and two one-to-one counselling sessions to pregnant women during third trimester~     and five newborn assessment visits in the neonatal period. In addition to this, community~     mobilization activities included formation of CHCs and creation of support for the uptake of~     the interventions. Control areas will continue to receive the routine standard health~     services of governmental and non-governmental organizations in the area. The intervention~     areas will receive the intervention package in addition to the routine standard health~     services. Outcome measures will include changes in maternal and newborn-care practices and~     perinatal and neonatal mortality rates between the intervention and control areas.~   "
49265|NCT02412267|"~     The purpose of this study is to determine the efficacy and safety of ofatumomab in~     combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following~     failure to combination rituximab and anthracycline based chemotherapy. Participants with the~     option of potentially curative stem cell therapy may proceed to high dose chemotherapy and~     stem cell rescue. Participants with disease not considered curable with stem cell therapy,~     ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study~     drugs.~   "
49266|NCT02412254|"~     The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old~     adults with hearing loss to best-practices hearing rehabilitative treatment (hearing~     assessment, counseling, fitting of amplification devices) versus a successful aging~     intervention (one-on-one counseling/education sessions on successful aging topics).~     Participants will be followed for 6 months, and outcomes will focus on communication,~     quality of life, cognition, and other functional surveys. This pilot study is in preparation~     for a larger planned trial to investigate if hearing loss treatment can reduce cognitive~     decline and dementia in older adults.~   "
49267|NCT02412241|"~     This four-year, prospective, longitudinal study will evaluate and validate a~     patient-reported outcome measure, clinician-reported outcome measures, and imaging~     techniques in assessing characteristics, trajectory, and progression of lymphedema and~     fibrosis (LEF) in oral cavity and oropharyngeal cancer patients.~      This clinical trial studies patient-and-clinician-reported measures as well as standard~     imaging methods to see how accurate they are in identifying and evaluating lymphedema~     (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients~     receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer.~     Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and~     chewing, as well as psychological and emotional symptoms, such as negative body image and~     avoiding social interactions. Finding an accurate test to identify and evaluate LEF may~     allow doctors to treat LEF more quickly and control symptoms more effectively, and thus~     provide patients with a better quality of life.~   "
49268|NCT02412228|"~     The goal of this proposal is to develop a more effective and better tolerated regimen.~     Ixazomib appears to have greater activity than bortezomib with less peripheral neuropathy.~   "
49269|NCT02412215|"~     This study aims to assess the rotational stability of the new collameric Nanoflex toric~     intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.~      The purpose of this study is also to determine whether the use of a toric intraocular lens~     (T-IOL) improves visual acuity.~   "
49270|NCT02412202|"~     Switching from positive airway pressure ventilation to spontaneous ventilation during~     weaning from mechanical ventilation, pulmonary edema may occur and in this case, doppler~     echocardiographic (U/S) indices of cardiac dysfunction correlates with the concentration of~     fluid in interstitial space.~      Forty consecutive mechanically ventilated critical ill patients who fulfill criteria for~     weaning from mechanical ventilation, will be included in this study. All patients will be~     evaluated daily and when the patients fulfill weaning criteria them they will undergo a~     2-hour spontaneous breathing trial (SBT) through a T-piece.~      Before and after SBT cardiopulmonary function will be assessed by thermodilution and~     echocardiography. In patients with preserved LV systolic function, an echocardiographic~     index of diastolic dysfunction (E/Em ratio) before preforming SBT may identify high risk~     patients for increasing extravascular water in weaning.~      In addition, the investigators expect to find positive correlations (p<0.05) between~     pulmonary extravascular lung water and echocardiographic indices (such as E/Em ratio) during~     SBT.~   "
49271|NCT02412189|"~     The arterial blood pressure affects the ratio between filtration and reabsorption of fluids~     in the circulating blood volume and thereby the hematocrit. During induction of anesthesia~     blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to~     evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction~     reduces the decrease in hematocrit.~   "
49272|NCT02412176|"~     Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony~     of left ventricular contraction. The pacing from the septum of the RV can present an~     advantage in terms of less expressed dyssynchrony and reduced negative impact on left~     ventricular (LV) function. However, results of randomized studies comparing apical and~     septal pacing are not uniform. All these results have been affected by improper implantation~     of the septal lead, with many apparently septal leads being, in fact, implanted off-septum.~     The aim of the study is to compare true septal pacing with other RV pacing locations.~      Methods/Design This is a prospective, randomized, single center study. Patients with~     standard indications for cardiac pacing with the expectation of high percentage RV pacing~     will be enrolled. They will be randomized into apical and septal pacing. The real location~     of leads in patients randomized to septal pacing will be confirmed using cardiac CT. After~     cardiac CT, three groups of patients will be created: 1) apical pacing, 2) true septal (in~     which the position of the lead has been verified to be in the septum), and 3) apparent~     septal (in which the position of the lead was found to be off-septum). Primary end-point are~     changes in standard echocardiographic parameters (LV ejection fraction, LV end-systolic~     volume, and LV end-diastolic volume) and the concentration of N-terminal pro brain~     natriuretic peptide (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary~     end-points are changes in echo-parameters of LV synchrony.~      Discussion It is hypothesized that correct septal pacing will be associated with reduce~     negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and~     smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.~   "
49273|NCT02412163|"~     This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail~     system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will~     receive treatment with the Ellipse IM HTO Nail System and followed for six months.~   "
49274|NCT02412150|"~     The purpose of the present study was to compare the effect of dexmedetomidine which is~     administered during emergence in adult patients undergoing elective thyroidectomy on smooth~     emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or~     tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital~     staying).~   "
49303|NCT02411773|"~     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have~     poor exercise capacity and what causes an increase in blood pressure during exercise (i.e.~     increased adrenaline levels, or decreased ability of blood vessels to dilate).~   "
49275|NCT02412137|"~     To measure the effectiveness of counseling on brace-wear compliance and curve progression in~     patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance~     is increased when it is measured and used to counsel patients, and therefore those patients~     will have less curve progression and fewer would need surgery.~      A second purpose is to evaluate whether there is a correlation between BMI and brace~     effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI~     have included decreased compliance due to discomfort and decreased force exerted on the~     curve due to the larger habitus.~   "
49276|NCT02412124|"~     This pilot clinical trial studies a peer-to-peer support program in improving quality of~     life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support~     and mentoring may help improve quality of life and reduce symptoms of distress in~     gynecologic cancer patients and their families.~   "
49277|NCT02412111|"~     This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,~     multicenter study in subjects aged 12 years and older with CF who are heterozygous for the~     F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically~     demonstrated to be ivacaftor responsive.~   "
49278|NCT02412098|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single~     oral dose of eleclazine in participants with normal and impaired hepatic function.~     Participants in the healthy control group will be matched to participants with impaired~     hepatic function by age (± 5 years), gender, and body mass index (± 10%).~   "
49279|NCT02412085|"~     This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid~     dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive~     subcutaneous golimumab treatment, according to EU marketing authorization from baseline~     through week 14.~      At week 16, patients achieving clinical and endoscopic remission will continue with~     Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.~      Patients not achieving clinical and endoscopic remission will be treated with infliximab,~     according to marketing authorization, and followed through week 52. This is not considered~     as an interventional arm but, since infliximab in Italy is considered as the first-line~     treatment for UC patients, as the usual clinical practice.~   "
49280|NCT02412072|"~     A prospective multicenter trial has been started in Korea to evaluate the diagnostic~     accuracy of endometrial aspiration biopsy compared with D&C in patients treated with~     progestin for endometrial hyperplasia (EH). For conservative treatment of EH, oral~     progestins are most commonly used method with various treatment regimens and more recently,~     the levonorgestrel-releasing intrauterine system (LNG-IUS) also has been used successfully~     to treat EH. However, there is no report about the accuracy of endometrial sampling during~     hormonal treatment for follow-up evaluation of EH. Patients with histologically confirmed EH~     are offered hormonal treatment, one of the following 3 options: oral medroxyprogesterone~     acetate(MPA) 10mg/day for 14days per cycle, continuous oral MPA 10mg/day, or insertion of~     LNG-IUS. Histological surveillance is performed at 3-months or 6-months following initial~     treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a~     pipelle and D&C. In case of using LNG-IUS, endometrial aspiration biopsy will be done with~     LNG-IUS in uterus and then, after removal of LNG-IUS, D&C will be done. The biopsy findings~     will be compared. The primary endpoint is the consistency of the results of the endometrial~     aspiration biopsy and D&C. The secondary endpoint is the response rate with 3 types of~     progestin treatment at 6 months.~   "
49281|NCT02412059|"~     In this prospective randomized controlled double blind pilot clinical study, we aim to~     assess whether administration of a topical corticosteroid would attenuate epiretinal~     membrane formation following development of retinal tears treated with laser retionpexy.~   "
49282|NCT02412046|"~     The aim of this study is to correlate the intensity and the duration of a mechanical strain,~     applied over the skin of a bedridden paraplegics, with the microvascularization parameters~     (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We~     want to detect the early stage of irreversible damage for each patient. To achieve this~     goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital~     for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups.~     First the interface pressure between the patient body and the air mattress is recorded~     continuously for 3 hours (= the repositioning patient frequency): we have the pressure over~     each point of the patient body in contact with the mattress on this time lap. Then, we will~     measure the microvascularization parameters, using an O2C medical device over a trochanter~     on a specific anatomical area which will be thereafter biopsied. Finally, depending on the~     group in which they were randomly distributed, the patient will undergo a muscle biopsy on~     his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way,~     we will be able to determine the effect of the mechanical strain duration on the physiologic~     parameters. The following day, the patient is undergoing his or her surgery for removing the~     necrotic area of the bedsore. At the same time, we will recover some of the sample near the~     bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy~     will be performed on an innervated area to be able to determine a basal concentration of~     biomarkers.~      The inclusion period for this study will be 3 years. All the patients are followed for 24~     hours then they will be followed by medical staff in their bedsore resection setting.~      The data gained for this study will hopefully help the scientific world to achieve a better~     understanding of the pressure ulcer aetiology. They will also be helpful to achieve a~     mobilization of the patient specific of his or her inherent characteristics with a high~     sensitivity level. This way we will have a more efficient bedsore prevention.~   "
49283|NCT02412033|"~     Intrauterine devices (IUDs) are widely used as reversible contraceptives. Both copper- and~     levonorgestrel (LNG)-releasing IUDs (LNG-IUDs) are safe,cost-effective in the long term and~     equally effective compared with tubal sterilization.~      In addition, the LNG-IUD (Mirena®) provides non contraceptive benefits, such as treatment~     for menorrhagia, dysmenorrhea and anemia. The current use of IUDs among reproductive-aged~     women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are~     8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope~     and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among~     women who have never delivered vaginally.~      Cervical stenosis, an immature or small cervix and a significantly ante- or retroverted~     position of the uterus, has been described as factors associated with a difficult sounding~     of the cervical canal or even failure to insert the IUD.~      Misoprostol is an inexpensive prostaglandin E1-analogue, which is associated with few side~     effect. More over several have shown the benefit of misoprostol as a cervical ripening agent~     in non pregnant women. Priming with misoprostol prior to hysteroscopy and dilatation and~     curettage (D&C) in perimenopausal women resulted in increased cervical dilatation and lower~     rate of cervical laceration.~      The effect of misoprostol on the cellular matrix causes dissolution of collagen fiber~     increasing the amount of fluid in the stroma and consequentially causes cervical effacement.~     Fear of pain during insertion, however, might prevent some women from choosing IUD and fears~     of painful and/or difficult placements may lead them to recommend or counsel women on other,~     less effective methods.~      Women's perception of pain is multifactorial and likely to be influenced by cultural~     differences and personal experiences; insertion-related pain is therefore difficult to~     predict. Nevertheless, factors associated with greater pain include nulliparity, not~     currently breastfeeding and longer time since last pregnancy; of these factors, nulliparity~     is the strongest predictor of pain.~      The proportion of women of reproductive age who are nulliparous is increasing, with women~     delaying childbirth and having fewer children or choosing to remain childless. The~     proportion of Caesarean section births has also increased and women who have only ever had a~     Caesarean section are often viewed as nulliparous with respect to IUD placement. Anticipated~     pain is often greater than the actual pain experienced, and the majority of nulliparous~     women experience no more than moderate pain during IUD insertion. However, among nulliparous~     women there is a subset (about 17%) for whom the insertion of IUD is associated with severe~     pain.These women need effective pain relief.~      For most nulliparous, nulligravid or parous women, IUD insertion can be performed~     successfully without cervical priming and with a minimum amount of discomfort. Whether~     selective use of misoprostol has a role in management of pain in certain subsets of women~     (e.g. nulliparous women and those in whom the insertion is non-routine/difficult) has yet to~     be adequately studied.~   "
49284|NCT02412020|"~     This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study~     in adult patients with refractory chronic cough.~      The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via~     eFlow high efficiency nebulizer for treating refractory chronic cough.~   "
49285|NCT02412007|"~     Activity based therapy is gaining interest for rehabilitation of children with cerebral~     palsy (CP). A home-based comprehensive programme structured on the principles of activity~     based therapy seems to hold promise in the field of rehabilitation of children with diplegic~     CP.This may reduce morbidity as well as promote better quality of life in these children .~     In this backdrop our study has been planned with an aim to evaluate the efficacy of a~     comprehensive home-centred activity based programme for children with diplegic CP.~   "
49286|NCT02411994|"~     The purpose of this study is to determine the efficacy of pyronaridine-artesunate and~     artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in~     Kenyan children.~   "
49287|NCT02411981|"~     This study will investigate the effects of on technique of chest physiotherapy on pulmonary~     function. Effects of pulmonary function will be measured by the spirometry, body~     plethysmography and by the multiple breath nitrogen washout technique.~   "
49288|NCT02411968|"~     Currently there is no consensus on post procedural follow up imaging following percutaneous~     cryoablation of renal tumors. Interpretation of conventional contrast enhanced imaging (CT~     and MRI) during follow up can be very challenging. The objective of this study is to~     evaluate the feasibility of early evaluation of the therapeutic effect by performing early~     follow up imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma~     using 111In-Girentuximab-DOTA SPECT CT imaging.~   "
49289|NCT02411955|"~     The purpose of this study is to evaluate the therapeutic equivalence and safety of~     Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).~   "
49290|NCT02411942|"~     The objectives of this study are to evaluate the therapeutic equivalence and safety of~     Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).~   "
49291|NCT02411929|"~     This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of~     ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and~     intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male~     participants.~   "
49292|NCT02411916|"~     This document defines the Clinical Investigation Protocol for a study designed to determine~     whether blood loss after spontaneous vaginal delivery is altered by the addition of~     misoprostol administration to the standard use of intravenous oxytocin after delivery. The~     protocol is an open-label randomized prospective trial to be carried out at Queens Hospital~     Center.~      Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit~     levels on admission in labor to those obtained within 24 hours after delivery.~   "
49293|NCT02411903|"~     The investigators team had found that the presence of dynamic changes of Clopidogrel~     resistance are not associated with genetic factors. Currently, study on moderate doses of~     statins and dynamic Clopidogrel resistance has not been reported, therefore this study will~     observe 160 cases of open prospective secondary prevention in patients with cerebral~     infarction. Excluded: those patients occurs Clopidogrel resistance because of slow~     metabolism caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of~     the cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4~     （CYP3A4）—metabolized statins dynamically on Clopidogrel resistance in the next 9 months,~     adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of~     cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome~     P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome~     P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance~     easily ,H4 levels will decline, and Clopidogrel resistance is not related to the~     polymorphism of cytochrome P450 isoenzyme 3A4 （CYP3A4）.~   "
49294|NCT02411890|"~     The aim of this study is to compare the efficacy in pain relief within 24 hours between~     adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction~     with hamstring graft.~   "
49295|NCT02411877|"~     The purpose of this study is to determine whether reducing a patient's body temperature~     (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain~     injury (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered~     a significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).This will be achieved by comparing patients who have undergone~     hypothermia to those who have not.~   "
49296|NCT02411864|"~     Our research aims to reveal whether the low b-values distribution and the number of NEX for~     each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in~     brain.~   "
49297|NCT02411851|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active~     compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment~     has been approved for the treatment of AKs. Ingenol mebutate gel 0.015% has shown to not~     only have a high clearance rate but also a transient localized inflammatory skin response~     that resolves quickly without sequelae. However, these localized skin responses (eg~     erythema, erosion/ulceration, edema, etc.) can often be unpleasant and unsightly. Currently,~     there are no clinical studies evaluating combination therapies (eg topical steroids,~     emollients) with ingenol mebutate 0.015% that would decrease irritation and improve wound~     healing while maintaining efficacy.~   "
49298|NCT02411838|"~     The investigators hypothesize that adipokine (soluble molecules produced by the adipose~     tissue) levels are altered in MS compared to control subjects. Additionally, the~     investigators hypothesize that calorie restriction (CR) will improve clinical recovery from~     an MS relapse, ameliorate the adipokine and metabolic-inflammatory profile in MS, and~     enhance immune-regulatory mechanisms.~      This is a pilot study to determine the effects of CR in MS patients during an acute MS~     relapse (Acute CR phase) and for 6 months afterwards (Chronic CR phase). Calorie restriction~     will be achieved by following a regimen of alternate day fasting. The investigators will~     evaluate clinical outcomes and blood biomarkers at different time points.~   "
49299|NCT02411825|"~     Primary Objective:~      To assess in healthy adult male subjects:~        -  The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899~          including two up titration steps.~        -  Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in~          plasma.~        -  Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin,~          biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).~      To assess in overweight to obese T2DM mellitus patients:~        -  The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up~          titration steps.~        -  PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.~        -  PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin~          panel (total and active ghrelin, total peptide YY [PYY], total and active glucagon-like~          peptide -1 [GLP-1], glucagon and total gastric inhibitory polypeptide-1 [GIP]), body~          weight, FGF21, biomarkers of lipid metabolism and HbA1c.~   "
49300|NCT02411812|"~     The purpose of this study is to determine if the Herbst appliance with indirect skeletal~     anchorage in mini-implants is capable of preventing excessive inclination of the lower~     incisors at the end of the treatment when compared to the Herbst appliance with dental~     anchorage in patients with Class II malocclusion and overjet ≥ 6 mm.~   "
49305|NCT02411747|"~     Simulation training in surgical education in Urology specialist training in flexible~     cystoscopy has been demonstrated a valid and efficient learning instrument. The classical~     setup with a medical expert introducing the novices to the theoretical background and~     technics of the procedure is time-consuming and expensive. Directed self-regulated~     simulation training (DSR) is a validated method in simulation training. The power of testing~     in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which~     the novices started by training in a directed self-regulated simulation training environment~     and informed them that they would be tested by a medical expert afterwards. The intervention~     group novices were given only written theoretical information and anatomical pictures. The~     control group were first given a classical oral theoretical introduction by a medical expert~     and secondly did DSR training. We tested the outcome of the intervention by a validated~     rating scale for flexible cystoscopy. The novices in both the control and intervention group~     were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in~     Urology.~      The main hypothesis was that testing in relation to DSR would result in higher scores on a~     validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist~     in Urology compared to a group having a oral lecture before DSR.~   "
49306|NCT02411734|"~     Executive function will be tested in patients admitted for rehabilitation and correlated~     with rehabilitation success~   "
49307|NCT02411721|"~     Studies have shown that about two thirds of the children undergoing MRI suffer from feelings~     of anxiety ranging from mild apprehension to severe distress. Especially in young children,~     the unfamiliar surroundings, new faces, strange equipment and the noise generated during the~     scan, can cause feelings of stress and anxiety so severe that the test either cannot be~     started or cannot be performed properly due to the child's movements. For older children and~     adults claustrophobia is the main reason of poor image quality because of motion artifacts~     and/or early termination of the scan. Several studies have demonstrated the potential~     calming effects of companion animals on children but, to date, no formal studies on the~     relationship between dog intervention and children's anxiety before MRI procedures have been~     reported. The current study is designed to determine if dog intervention lessens children's~     anxiety prior to MRI~   "
49308|NCT02411708|"~     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a~     vaso-occlusive crisis~   "
49309|NCT02411695|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric~     Disorders.~   "
49310|NCT02411682|"~     Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2~     diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and~     overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of~     skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner~   "
49311|NCT02411669|"~     A national context for patient centered care development exists in France at hospital with~     strong support for the implementation of operational patient centered care tools. Patient~     centered care is a global vision of patient or family management promoting the respect of~     patient freedom, of patient listening and of patient needs. Patient centered care is an~     important issue of quality and security of care. The FORAP (Fédération des Organismes~     Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la~     HAS (High Authority of Health) have developed and validated five tools promoting patient~     centered care at hospital.~      They can be implemented one by one or in association according to hospital situation.~     Hospitals should identify the association of tools fitting the most to their objectives and~     the actions already done.~      The objectives of the project are to analyse the effectiveness of the implementation of HAS~     - FORAP tools on the development of patient centred care at hospital and to analyse the~     individual and organisational determinants of their effectiveness. It focuses on acute care~     hospitals that have the choice of the combination of tools and that are followed during two~     years with combined quantitative and qualitative analyses. Quantitative assessment are based~     on validated indicators on patient satisfaction, patient centred care development and~     organizational context. Qualitative data collection are realised in each included hospital~     and combine individual interviews and focus groups including Physicians, nurses and~     managerial staff.~   "
49312|NCT02411656|"~     The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475~     and Keytruda) can help to control metastatic IBC. The safety of this drug will also be~     studied.~   "
49313|NCT02411643|"~     This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene~     ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea~     lesions before and after treatment with topical calcipotriene 0.005% ointment will be~     analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be~     obtained and used for a control. This is an initial study to look at the molecular effects~     of topical calcipotriene on human morphea-involved skin. This study will look at the~     differences between affected and unaffected skin. This study also will look at clinical~     outcomes in morphea patients and determine if there are any clinical predictors for~     improvement with the medication.~   "
49314|NCT02411630|"~     The purpose of this study is to test a new way to take a questionnaire that asks about~     adherence (whether the person is taking the medicine correctly). This new questionnaire is~     called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on~     HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another~     study, either ATN 110 or ATN 113.~   "
49315|NCT02411617|"~     Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage~     is used routinely to reduce incidence of seroma. Usually two drains are used in patients who~     underwent MRM to reduce post operative seroma. It is often associated with significant~     patient discomfort and prolonged fluid drainage.~      The aim of this study is to evaluate effect of number of drains on seroma formation rate,~     postoperative pain and hospital stay during the immediate postoperative period after~     mastectomy for breast cancer.~   "
49316|NCT02411604|"~     Open label, multi-center, expanded access study for renal transplant patients with once~     daily Envarsus XR (Tacrolimus).~   "
49328|NCT02411448|"~     The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in~     combination with erlotinib as compared to placebo in combination with erlotinib in~     participants with stage IV non small cell lung cancer (NSCLC) harboring an activating~     epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability~     of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A)~     before proceeding to the second portion of this study (Part B).~   "
49329|NCT02411435|"~     CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment~     and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used~     for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known~     inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4~     (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction~     between CAB and RIF is possible. This study will be a phase I, single-center, open label,~     fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg)~     when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg~     administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable~     subjects for this study.~   "
49330|NCT02411422|"~     The investigators will compare conventional intubation using Macintosh laryngoscope, blind~     endotracheal intubation using i-gel for conduit and bronchoscopic intubation using~     Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest~     compressions continuously without interruption.~      Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has~     more soft tube tip, so the investigators think it is more acceptable for intubation using~     i-gel as conduit.~   "
49331|NCT02411409|"~     The CommunityRx system generates patient-centered e-prescriptions for community services~     (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive~     community resource database. Based on a patient's diagnoses, a HealtheRx will be printed~     automatically at the end of the ambulatory care visit and will provide patients with a~     customized map and/or list of places in their community that provide health and social~     services as well as contact information for a local community health worker who can provide~     limited case management support. The CommunityRx program aims to promote: 1) better~     healthcare, 2) better health, and 3) lower cost. The purpose of this research is to~     systematically evaluate the impact of CommunityRx on health outcomes as well as health care~     service utilization and total cost of care for Medicaid, Medicare and other beneficiaries.~     The investigators hypothesize that beneficiaries who participate in the CommunityRx~     intervention will experience better healthcare, better health and lower total cost of care.~   "
49332|NCT02411396|"~     The Emergency Department has been the standard location where patients with Sickle Cell~     Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive~     Crisis (VOC) is the most common complication of SCD,~      The purpose of this study is to compare patient centered outcomes for patients being treated~     for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four~     locations around the US.~   "
49333|NCT02411383|"~     This study is a prospective, single-center feasibility study to acquire more knowledge~     regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with~     this system during the weaning period from mechanical ventilation in the Intensive Care Unit~     in patients after bilateral lung transplant.~   "
49334|NCT02411370|"~     Communication is essential for patients quality of life because it impact on patients care~     quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal~     communication of the patient. Therefore, speech must to be functional.~      However, correlation between respiratory failure and voice quality is not very well known.~     The aim of the study is to search a link between respiratory failure and speech impairment~     in patients with neuromuscular diseases.~   "
49335|NCT02411357|"~     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was~     unintended and the majority of non-pregnant opioid-maintained women do not use contraception~     or use less effective methods like condoms. This proposal aims to further test a novel~     contraceptive management program to increase use of more effective contraceptives among~     opioid-maintained women at risk of unintended pregnancy.~   "
49336|NCT02411344|"~     The purpose of this study is to evaluate the activity of molecular response in endocrine~     sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus~     Ietrozole.~   "
49337|NCT02411331|"~     Implantable venous access port infections are mainly due to coagulase negative staphylococci~     and may be managed by antibiotic lock therapy with retention of the port. Most of the time a~     vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in~     eradicating the staphylococcal biofilm in the port. Another disadvantage of~     Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of~     catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does~     not expose to the risk of emergence resistance.~   "
49338|NCT02411318|"~     This study will determine how common lifestyle practices affect the behavior of neutrophils~     (a type of immune cell) at shorter time scales than previously possible.~   "
49339|NCT02411305|"~     Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative~     care exist. Such infrastructure is needed to understand current clinical practices, inform~     quality improvement projects, and research which links adherence to specific quality~     measures and improved patient-centered outcomes. This infrastructure, if proven feasible,~     can then become integrated into usual palliative care delivery across the PCRC. Then,~     palliative care can conduct the same types of collaborative quality improvement activities,~     based on data collected at point of care, as other medical disciplines like general surgery~     and cardiology.~   "
49347|NCT02411201|"~     The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of~     children aged less than 2 years thanks to several blood samples (3 ml in total) taken~     following the administration of DOTAREM®.~      DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging~     (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged~     less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region~     may take part in the study. In this case they will receive DOTAREM®, a solution injected at~     the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.~   "
49340|NCT02411292|"~     Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is~     an important patient safety issue in plastic surgery. Previous work in plastic surgery has~     shown that enoxaparin prophylaxis can prevent many post-operative VTE events, and current~     American Society of Plastic Surgeons guidelines support enoxaparin prophylaxis for high-risk~     patients. However, the Plastic Surgery Foundation-funded Venous Thromboembolism Prevention~     Study showed that one in 25 highest risk patients still had a breakthrough VTE event~     despite receipt of guideline-compliant enoxaparin prophylaxis. Highest risk patients often~     have cancer or trauma reconstruction. These surgeries may have surgical injury that is equal~     in scope to patients with traumatic or thermal injury. Previous work in patients with~     traumatic or thermal injury has shown that enoxaparin metabolism, measured by anti-factor Xa~     (aFXa) level, is substantially increased: a higher degree of injury is associated with~     higher enoxaparin dose requirements to achieve prophylactic levels. Breakthrough VTE~     events may occur in plastic and reconstructive surgery patients due to inadequate enoxaparin~     dosing. The investigators will examine enoxaparin pharmacokinetics and will test whether a~     clinical protocol for real-time enoxaparin dose adjustment can favorably alter the~     proportion of patients with in-range aFXa levels. Primary outcomes will include 1) peak and~     trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin~     and 2) the proportion of patients with appropriate aFXa levels before and after initiation~     of a clinical protocol for enoxaparin dose adjustment. The investigators expect that~     standard dosing will result in inadequate aFXa peak and trough levels, and that the clinical~     dose adjustment protocol will significantly improve the proportion of in-range aFXa levels.~     The investigators will also develop a linear regression-based equation to calculate, based~     on patient-level factors, the required dose of enoxaparin to generate in-range aFXa levels.~     This research may show that the current one size fits all approach to enoxaparin~     prophylaxis is insufficient. In the trauma and orthopaedic populations, patients with low~     initial aFXa levels are significantly more likely to develop DVT. Thus, this research has~     important implications for appropriate enoxaparin dose magnitude and frequency, and may~     ultimately help to decrease the substantial morbidity and mortality associated with~     post-operative VTE.~   "
49341|NCT02411279|"~     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which~     can be prevented by early action. The management of HF is complex: long, often difficult and~     costly. In France, nearly one million people suffer from HF and 120,000 new cases are~     diagnosed every year. With the aging population, this number will continue to evolve and~     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart~     failure in either the 3 most common diseases in industrialized countries.~      The objective of the project is to test an intelligent platform for monitoring at home,~     using non-intrusive sensors, patients with heart failure, particularly those with stage II~     and III NYHA. It will assist the medical automating the processing of information from these~     sensors to detect and report an early stage risk situations.~      Patient monitoring, by a system of telemedicine tools associated with motivation and~     education helps significantly reduce the number of days of hospitalization becomes important~     when the patient is hospitalized for acute HF.~   "
49342|NCT02411266|"~     In remote preconditioning, ischemia in one organ protects distant organs from ischemic~     insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe~     stroke. The investigators propose a study of limb preconditioning in subjects with~     subarachnoid hemorrhage who are at high risk of cerebral ischemia in the first 2 weeks after~     hemorrhage. The investigators have previously shown that 3x 10min leg conditioning cycles~     are tolerated and appear safe. The investigators are now continuing to assess the safety of~     the intervention by enrolling an additional 60 patients.~   "
49343|NCT02411253|"~     Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells,~     leading to an absolute deficiency in insulin.~      In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and~     likewise prevent autoimmune diseases. Tregs are insufficient in T1D.~      The investigators previously showed that administration of low doses of IL-2 induces~     selective expansion and activation of Tregs in mice and humans.~      The investigators hypothesize that Tregs expansion and activation with low doses of IL2~     could block the ongoing autoimmune destruction of insulin producing cells in patients with~     recently diagnosed T1D.~   "
49344|NCT02411240|"~     Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated~     with increased morbidity and mortality related to respiratory and cardiovascular disease.~     Proposed biological pathways imply that particle-induced inflammation plays a role in~     activating the vascular endothelium and altering vascular function. Accumulating evidence~     suggests that outdoor air pollution has a significant impact on central nervous system~     health and disease and living in conditions with elevated air pollution has been linked to~     decreased cognitive function.~      Only recently was shown that reductions in ambient levels of PM2.5 were associated with~     improvements in life expectancy. However, studies of the beneficial effects of improved~     indoor air quality on healthy humans are lacking.~      With this project the investigators intend to study the effects of rooms with clean air in~     the elderly with the emphasis on cardiovascular and cognitive function. The investigators~     hypothesise that by means of air cleaning, controlled and reduced exposure has a positive~     effect on cardiovascular parameters such as blood pressure, heart rate variability, macro-~     and microcirculation and on neurobehavioral function. The investigators substantiate these~     outcomes with potential mechanisms of action at the transcript and epigenetic level as with~     hematological parameters, markers of inflammation, lipid and protein oxidation products and~     mitochondrial DNA damage. To achieve these goals there is a specific need to study the~     elderly, as they appear to have elevated susceptibility and have the largest attributable~     risk related to indoor PM, as they spend more time indoors. Suited concepts for study~     location are elderly homes (service flats) and retirement homes.~      The ELiFA-cohort stands for Elderly Living in Filtered Air consisting of an intervention~     study during 2-week periods of a pre-purification (baseline), active purification and a post~     purification period.~   "
49345|NCT02411227|"~     Background:~      - People with traumatic brain injury (TBI) can have problems with thinking and everyday~     activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality~     driving simulator. Researchers think it can help test and improve how people think and drive~     after TBI.~      Objective:~      - To test how NeuroDRIVE affects brain performance and driving safety.~      Eligibility:~      - People at least 18 years old with a history of TBI and who had a driver s license at some~     point. They must speak, read, and write English and be physically able to drive.~      Design:~        -  Participants will be asked to release their driving records, but they do not have to do~          this to be in the study.~        -  Visit 1: Screening physical exam.~        -  Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that~          slides into a cylinder with a strong magnetic field. A device will be placed over the~          head. Participants may do computer tasks during the scan.~        -  Participants will have tests of memory, attention, and thinking. They may be asked~          questions, take tests, and do simple actions.~        -  Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving~          assessment.~        -  Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or~          Group 2 to start 10 weeks later.~        -  Visits 4 9, over 4 weeks:~        -  Participants will practice driving skills and mental exercises in the simulator.~        -  They will complete a driving questionnaire online each week.~        -  Visit 10: Repeat of Visit 3, with some small changes.~        -  Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam;~          questionnaires; and tests of thinking, memory, and attention..~        -  After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.~   "
49346|NCT02411214|"~     The survey analyses how to improve the decision-making process for fertility preservation in~     the pediatric population based on~        1. patient and parent feelings about fertility preservation counselling~        2. influence of the emotional state of patients and parents on fertility preservation~          acceptance~        3. support of medical staff and family The study revealed that attention to the fertility~          preservation pathways was important for the satisfaction of patient's and parent's~          expectations~   "
49397|NCT02410551|"~     The goal of this clinical research study is to learn if giving pacritinib before standard of~     care drugs followed by an allogeneic stem cell transplant can help to control~     myeloproliferative neoplasms. The safety of this therapy will also be studied.~   "
49348|NCT02411188|"~     The goal of the proposed project is to determine if providing an intervention for women who~     decline the invitation to participate in standard cardiac rehabilitation programs (CRPs)~     will ultimately result in an increase their participation in CRPs.This study will evaluate~     outcomes of patients randomized to the FHHS STEP Program versus by non-STEP Program~     participants. The overall goal is to provide an alternate, introductory program that will~     engage, educate, and empower women following a cardiac event. Providing these women with the~     necessary personal resources will encourage and enable these women to take the step towards~     a cardiac rehabilitation program, which, in turn will ideally lead to a life-long commitment~     to heart health.~   "
49349|NCT02411175|"~     Constipation is an umbrella term encompassing either infrequent bowel movements, difficult~     evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15%~     of the global population. Constipation may negatively impact physical health, moods and~     social life. There exists a 50% dissatisfaction with traditional approach of laxative use.~     Conventional laxatives only offer a temporary solution and may cause dependency.~     Side-effects of conventional laxatives include nausea, vomiting, flatulence, diarrhoea,~     abdominal pain, electrolyte imbalance and skin eruptions. Homeopathy is a potential~     treatment option for constipation, however further research is needed in this regard.~      The aim of this study is to determine the efficacy of individualised homeopathic treatment~     on constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool~     Form Scale.~   "
49350|NCT02411162|"~     This will be an open-label, non-randomized, single-center study to assess the residency of~     GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The~     study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will~     assess the residence time in human skin . The primary objective is to evaluate the residency~     time in skin following topical application of two formulations of GSK2894512 Cream. The~     total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14~     days of post treatment period and 1 day of follow up. The screening period will be up to 28~     days prior to Baseline (Day 1).~   "
49351|NCT02411149|"~     This study aims to compare the functional recovery of patients undergoing Total Knee~     Arthroplasty based on the administration of an adductor canal block during their anesthesia~     treatment~   "
49352|NCT02411136|"~     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus~     erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period,~     and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.~   "
49353|NCT02411123|"~     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on~     clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as~     depression and anxiety, as compared to a group of subjects with the same attributes without~     the guidance of PGx testing for their treatment.~      This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug~     events, hospitalization rates, hospital length of stay, emergency room visits, disability,~     death or other serious drug side effects.~   "
49354|NCT02411110|"~     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder~     pain syndrome.~   "
49355|NCT02411097|"~     To investigate whether preemptive analgesic of femoral nerve block could prevent deep venous~     thromboembolism due to inhibiting the excessive release of neutrophil elastase and~     inflammatory cytokines.~   "
49356|NCT02411084|"~     The objectives of this study are to determine the efficacy and safety of BEGEDINA® in~     subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and~     complex immunological disease occurring in some recipients of allogeneic hematopoietic stem~     cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI)~     tissues. The disease is life threatening and may be acute or chronic and the first choice~     treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive~     corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to~     this treatment leading to disease progression and a high rate of morbidity and mortality,~     primarily from infections and/or multi-organ failure. There are currently no other~     satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and~     binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells~     and inhibits the immune response leading to improvement in patients that have shown steroid~     resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and~     effective treatment for steroid-resistant GvHD patients where no other such treatments are~     currently available.~   "
49357|NCT02411071|"~     Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in~     Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for~     routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and~     immune cells.~   "
49358|NCT02411058|"~     In this experiment, the investigators will test the effectiveness of a two week 20x~     incentive multiplier on the investigators' corporate partner's users who are (a) not~     notified about the incentives in advance, and (b) notified about the incentives and their~     purpose. The investigators will test which group shows the largest boost in walking during~     the two week intervention and the most lasting behavior change.~   "
49359|NCT02411045|"~     In this study, the investigators ask the question: can incentivizing smaller, less costly~     behaviors—like just getting yourself dressed to go to the gym—be more effective (and~     palatable) than incentivizing the larger goal directly?~   "
49360|NCT02411032|"~     The investigators are proposing an experiment to help Humana investigate when to launch~     programs or send messages that are designed to improve customers' engagement. The~     investigators' past research has shown that certain life events and calendar events (e.g., a~     job change, a birthday, a holiday, Monday) feel like a fresh start to people and have the~     potential to motivate them to begin pursuing their health goals (e.g., exercising, starting~     a diet, quitting smoking).~   "
49361|NCT02411019|"~     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6~     and E7 specific T cell response and lesion condition in subjects who have administered in~     DNA-based therapeutic vaccine.~   "
49362|NCT02411006|"~     The investigators seek to increase medication adherence of subjects. The investigators will~     send mailings to customers of an insurance company, asking them to predict or commit to a~     certain level of behavior. The investigators will measure whether this increases medication~     adherence.~   "
49363|NCT02410993|"~     According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was~     recommended for three-vessel coronary artery disease and left main coronary artery disease~     in the patients with stable ischemic heart disease as class I. 2-VD with proximal left~     anterior descending artery stenosis was also indicated for CABG surgery as class I~     recommendation. However, many patients have been recommended for PCI by catheterization~     laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI~     candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance~     between real practice in catheterization laboratory and guideline would be adjusted by~     recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in~     real practice have been getting toward more PCI and less CABG surgery. In this study, we~     will identify the rate of CABG candidates who were treated with PCI or medical treatment~     instead of CABG surgery in different from current guideline. We are also going to compare~     two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical~     outcomes.~   "
49364|NCT02410980|"~     The researchers will assess the effects of treatment with tretinoin cream on human skin by~     using non-invasive optical imaging technologies.~   "
49365|NCT02410967|"~     This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic~     referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and~     related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of~     participants will receive 8 sessions of computer administered ABMT and the other half of~     participants will receive a 8 sessions of a computer administered control task.~   "
49366|NCT02410954|"~     Locus coeruleus (LC) norepinephrine (NE) neuron activity has been convincingly linked to~     regulation of acute fear. This study will address whether LC NE activity examined through~     pupil measures will reflect carbon dioxide (CO2) induced fear-responses in humans and if~     transcranial direct current stimulation (tDCS) can mitigate these effects. A 2 year R21~     phase establishing feasibility, tolerability, safety, and proof-of-concept (POC) in terms of~     capacity to engage LC NE neurons with tDCS, followed by a 3 year R33 parallel-group,~     double-blind, randomized, controlled trial will determine the degree to which engaging LC NE~     neurons with tDCS improves clinical symptoms.~   "
49367|NCT02410941|"~     Utilization of diagnostic imaging in the Emergency Department has increased dramatically~     over the past two decades, driven by an increased availability of advanced imaging, legal~     pressures to exclude serious diagnoses in low-risk patients, patient expectations, and the~     tendency to associate more testing with a higher quality of care. However, this rise in the~     use of diagnostic imaging, particularly in low-risk patients, may not be taking into account~     the risk of radiation exposure to patients, or the impact on finite health system resources.~     The objective of this project is to improve the appropriateness of CT imaging in Alberta~     Emergency Departments by advancing awareness of, and adherence to, evidence-based guidelines~     for CT imaging of patients with mild traumatic brain injury (MTBI) and suspected pulmonary~     embolism (PE). These two clinical scenarios have been selected because of evidence of~     significant variation in imaging practices across Alberta, and the robust evidence base that~     exists to guide CT imaging decisions such as the Canadian CT Head Rule and the Pulmonary~     Embolism Rule Out Criteria.~   "
49368|NCT02410928|"~     Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize~     the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy,~     videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy,~     duration and hemodynamic responses during the procedure.~   "
49369|NCT02410915|"~     Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on~     short- and long-term functioning, disability and health compared to conventional gait~     training as part of an inpatient rehabilitation program early after stroke.~   "
49370|NCT02410902|"~     The purpose of this study is to determine whether CM-AT is safe and effective in treating~     the core symptoms of autism in children with all levels of fecal chymotrypsin.~   "
49371|NCT02410889|"~     The purpose of this project is to develop the method of combined recording of~     electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) in order to~     improve understanding of the relationship between electrical (EEG) and blood flow (fMRI)~     responses to epileptic discharges as a necessary step towards clinical use. One factor that~     currently limits the use of EEG−fMRI in patients with epilepsy is that a relatively large~     proportion of patients do not show any fMRI response despite epileptic activity having been~     detected on the EEG recorded during scanning. The reasons for this are unclear, which makes~     it difficult to predict in advance whether useful information will be gained from the~     scanning session. What is it about some epileptic discharges that results in a detectable~     change in the fMRI signal, while others which are no less obvious or frequent do not? This~     question will be addressed by determining the factors that are responsible for the~     occurrence of robust fMRI signal changes via detailed morphological, topographical and~     spectral analysis of the EEG signal on an event by event basis.~   "
49372|NCT02410876|"~     Patients with obstructive or neurogenic lower urinary tract disease will be invited to~     participate. Upon agreement they will undergo an assessment of bladder function~     (questionnaires) and bladder biopsies at 2 time-points. Bladder biopsies will be evaluated~     for molecular changes in the laboratory and compared to the functional findings.By~     uncovering the molecular similarities and differences between BLUTD and NLUTD, the~     investigators will elucidate some of the causative factors in the development of these~     disorders and highlight the impact of myogenic and neurogenic components postulated to be~     involved. The project involves close collaboration between clinical and basic research.~   "
49373|NCT02410863|"~     This is an open-label, multi-center, clinical phase II study to explore the correlation of~     the genetic make-up of the treated tumor before start of therapy and to correlate clinical~     response at 8 weeks as well as metabolic response at 2 and 8 weeks with genetic features of~     the tumor.~      It will be conducted as a rationale optimization of targeted therapy in BRAF naïve and~     pretreated patients.~      Prerequisite for all patients is the availability of tumor sample at start of treatment in~     order to determine the underlying driver mutation (BRAF mutational status) as well as~     molecular composition by next generation sequencing (NGS) and assessable lesions for biopsy~     at week 2. Melanoma patients in stage III (non-resectable) and stage IV are sorted into~     Cohort A,B or C according to their previous BRAF-treatment and treated with dabrafenib and~     trametinib (cohort A and C) or dabrafenib (cohort B).~   "
49374|NCT02410850|"~     Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during~     sleep. OSA have been associated with the obesity epidemic in developing countries;~     additionally, high OSA prevalence rates are present in populations with cardiovascular and~     metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy~     and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical~     treatment and few studies have analyzed their long-term effectiveness for patients with OSA.~     The purpose of this study is to assess the long-term effectiveness of OA therapy in patients~     with OSA and to explore any changes on cardiovascular related morbidity and mortality~     related to this therapy.~   "
49375|NCT02410837|"~     The purpose of this study is to evaluate outcomes following electromagnetic navigation~     bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.~   "
49376|NCT02410824|"~     Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.~   "
49377|NCT02410811|"~     The purpose of this study is to use cardiac magnetic resonance imaging (CMR) and~     echocardiographic tissue Doppler imaging to demonstrate a unique restrictive cardiomyopathy~     of sickle cell disease. The investigators will characterize its frequency and how it might~     change (e.g., presence/absence and severity) over a 2-year period.~   "
49378|NCT02410798|"~     The overall goal of this feasibility study is to advance the development of NeuRx DPS for~     the intended use of stimulating the diaphragm to provide respiratory assistance in patients~     at risk of prolonged mechanical ventilation in the ICU. This is the first step to determine~     the technical feasibility of the short-term TransLoc DPS electrode in humans.~   "
49379|NCT02410785|"~     The polyglucosamine, specification L112 is a medical device and in this clinical trial used~     for weight reduction of overweight and obese participants. The rationale for this study is~     to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals~     with the highest fat content.~   "
49380|NCT02410772|"~     The purpose of this study is to determine whether one or two four-month regimens of~     tuberculosis treatment are as effective as a standard six-month regimen for treatment of~     pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each~     week, with direct observation of each dose by a health-care worker at least five of the~     seven days of each week.~      The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and~     pyrazinamide followed by four months of isoniazid and rifampin.~      The first short regimen is a single substitution of rifapentine for rifampin: two months of~     isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid~     and rifapentine.~      The second short regimen is a double substitution of rifapentine for rifampin and~     moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and~     pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.~      Target enrollment is 2500 participants. Each study participant will remain in the study for~     18 months in order to include at least 12 months of evaluation of whether the participant's~     TB recurs.~   "
49381|NCT02410759|"~     200 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).~   "
49382|NCT02410746|"~     Effective postoperative pain control is an essential component of surgery. Adequate~     analgesia improves patient comfort and satisfaction, thereby permitting earlier~     mobilisation, faster recovery and less likelihood of complications.The majority of surgeons~     will place 10ml of local anaesthetic into the breast pocket or inject it into the breast~     skin following breast surgery. A more specific technique is to identify the nerves supplying~     the breast and put the local anaesthetic directly around them (Pec block). This nerve block~     has recently been described and is increasingly being used by anaesthetists for surgery~     under local anaesthetic or for post-operative analgesia. It has been shown to provide better~     and more specific pain relief in several studies.~      Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves~     and they inject into the vicinity. They do not have direct vision and there is a risk of~     causing morbidity or the block not being effective. It is much easier for a surgeon to apply~     the block, as they can see the anatomical landmarks. Despite this, very few surgeons are~     aware of the technique.~      The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI~     Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and~     Worcester. If a patient consents to being involved in the research, they will have one~     breast randomised to receiving a pec block and the contralateral (opposite) breast will~     receive the same amount of local anaesthetic placed in the breast pocket in a non-targeted~     fashion. The patients and researcher will be blinded as to the allocation. Patients will~     complete a verbal numeric pain score for each breast at set intervals until they are~     discharged.In addition, the investigators will specifically ask which breast is the most~     painful at each time point.~      The results of the study may improve patient care.~   "
49383|NCT02410733|"~     The purpose of this study is to determine the safety and tolerability of intravenous~     administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated~     antigens in patients with advanced melanoma.~   "
49384|NCT02410720|"~     Colonoscopy is the preferred procedure to investigate any large-bowel disease in adults and~     children. In addition, colonoscopy is the current gold standard for colorectal cancer~     screening due to its high diagnostic capabilities and its unique feature that permits~     sampling and removal of pathology. For optimal performance and visualization of details,~     however, an adequate bowel preparation is essential. Inadequate bowel preparation is~     associated with cancelled procedures, prolonged procedure time, incomplete examination,~     increased cost and possibly complications, physician frustration and patient anxiety, but~     most importantly serving to impede colorectal cancer screening and surveillance.~      A good bowel preparation would need a solution with a reasonable volume, acceptable taste,~     minimal diet restrictions, and easy to follow instructions; and would also need patients'~     adherence to the instructions and diet restrictions. Noncompliance of patients to the diet~     restrictions, the starting day of diet, the timing of drinking the solution, and other~     instructions play an important role in rendering the colon preparation inadequate.~      Aim: The investigators aim, at assessing the influence of having a reminder mobile~     application on the compliance and adherence to instructions and diet and consequently on the~     quality of colon preparation.~      Hypothesis: The investigators' hypothesis is that patients having a customized mobile App~     reminding them systematically about instruction and time of intake of the preparation will~     have a better adherence to the prep protocol and likely on the quality preparation than~     those given written and verbal instructions in clinic.~   "
49409|NCT02410395|"~     The aim of this trial was to compare two different uterotomy surgical techniques on the~     occurrence of a uterine niche and the risk of a number of short- and long-term gynecological~     complications associated with the presence and size of the niche.~   "
49385|NCT02410707|"~     The purpose of this study is to describe the safety and efficacy of nitrous oxide~     administration for pain and anxiety before propofol in patients requiring any procedure~     under sedation in the Emergency Department. Procedural sedation is the use of sedative,~     analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic~     and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but~     provides no analgesia. Short acting opioids may be used for pain relief, but come with the~     risk of respiratory depression. An optimum analgesic to relieve pain in patients who need~     procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may~     be a suitable agent, but literature supporting or rejecting its use in adults is lacking.~     This study aims to fill this gap. Adult patients capable of consenting, coming to the~     Emergency Department with painful condition requiring procedural sedation are the targeted~     population. Eligible patients who consent to the study will receive Nitrous Oxide gas~     delivered through a hand held mask before they receive propofol for the procedure.~     Information regarding their vitals, pain scores and medical condition will also be~     collected.~   "
49386|NCT02410694|"~     Overview of Study Design:~      This is an open phase II, single-arm, multi-center study to evaluate progression free~     survival in patients receiving ixazomib in combination with thalidomide and dexamethasone~     (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.~      The patient population will consist of adult male and female patients with multiple myeloma~     (MM) with relapsed and/or refractory disease after at least one prior treatment line.~      In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide~     100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in~     patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number~     of cycles is 8. Treatment will be discontinued in case of progressive disease or in case of~     no response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of~     treatment visit (EOT) will be performed within 14 days after the last dose of the last~     combination treatment cycle.~      After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients~     aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be~     administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed~     less than 8 cycles of ITD treatment do not qualify for maintenance phase.~      Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib~     maintenance therapy has concluded or discontinued the maintenance phase.~      A safety analysis will be conducted after enrollment of the first 6 patients and completion~     of at least two cycles in every patient.~   "
49387|NCT02410681|"~     Excessive mechanical forces can cause complications of dental implants and their~     suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft~     tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during~     sleep) is considered as an important source of mechanical forces in the oral environment.~     Therefore, in this study, the investigators will investigate whether sleep bruxism is~     associated with implant and peri-implant complications.~   "
49388|NCT02410668|"~     To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory~     factors in subjects with over weight and obesity, 50 patients will be randomly allocated to~     receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to~     adherence the investigators' diet and exercise program too. At the first and the end of the~     intervention, weight, waist and hip circumference, lipid profile and some inflammatory~     markers will be assessed and compared between groups.~   "
49389|NCT02410655|"~     The purpose of this study will be to evaluate a standardized, evidence-based protocol versus~     a conventional approach for the dosing of oxytocin in vaginal delivery.~   "
49390|NCT02410642|"~     NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker~     of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical~     significance, pattern of excretion and links to perioperative factors are poorly described.~     We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary~     bypass, and explore possible associated variables.~   "
49391|NCT02410629|"~     The investigators are trying to determine the therapeutic effect of the music glove and~     conventional hand exercise program to the subacute stroke patients. All participants will be~     randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3~     weeks with a minimal 3 hours exercise time per week. Participants will receive the other~     intervention at 3-month post stroke date. Clinical evaluations will be performed at~     baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month~     post stroke, post therapy after second intervention, 3-week post second intervention follow~     up, and 6-month post stroke follow up visits.~   "
49392|NCT02410616|"~     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy~     (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss~     patients in secondary care~   "
49393|NCT02410603|"~     The purpose of this study is to explore the detection of circulating tumor DNA, soluble~     immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).~   "
49394|NCT02410590|"~     The primary objective of this trial is to compare the preference between two strategies of~     neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic~     abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium +~     Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS)~     scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is~     that the strategy Rocuronium + Sugammadex provides a better surgical visual field in obese~     participants undergoing laparoscopic abdominal surgery than the strategy Succinylcholine +~     Cisatracurium + Neostigmine/Atropine as measured by VNS scores.~   "
49395|NCT02410577|"~     The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for~     humanized antibody called J591, that is attached to a radioactive material called~     Zirconium-89) in patients with glioblastoma multiforme.~   "
49396|NCT02410564|"~     To determine the efficacy of a CBT-I intervention in improving sleep and other quality of~     life outcomes during cancer treatment. To assess the feasibility and acceptability of a~     CBT-I intervention among newly diagnosed cancer patients.~   "
49398|NCT02410538|"~     The intervention consists of the delivery of a list of 21 questions to the relative of each~     patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of~     the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The~     information comprehension at Day 5 (± 1) will be compared between families that received the~     list of FAQ and families that received information as usual (without providing the list of~     FAQ~   "
49399|NCT02410525|"~     In this study, radioactive PF-06427878 will be administered, through a vein, alone and with~     2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects.~     Positron emission tomography will be used to characterize tissue distribution. The study~     will also characterize how the study drug behaves in the body, its safety, and how the body~     tolerates it.~   "
49400|NCT02410512|"~     This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and~     pharmacokinetics of the combination of MOXR0916 and Atezolizumab with or without bevacizumab~     in participants with locally advanced, recurrent, or metastatic incurable solid malignancy~     that has progressed after available standard therapy, or for which standard therapy has~     proven to be ineffective or intolerable, or is considered inappropriate; or for which a~     clinical trial of an investigational agent is a recognized standard of care.~   "
49401|NCT02410499|"~     The purpose of this study is to characterize the effects of 85 days treatment with MLN1202~     on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced~     kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on~     average of 3 consecutive first morning voids sample collection.~   "
49402|NCT02410486|"~     This prospective surveillance study will be conducted over a 2 year period to determine~     current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated~     pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.~   "
49403|NCT02410473|"~     Neonates, children with single ventricle congenital heart disease, and those undergoing~     multiple complex cardiac surgeries are at high risk of increased perioperative blood loss,~     and blood product transfusions. In addition, some of these patients will present an~     increased risk of postoperative thromboembolic complications. For a long time, bleeding~     management has been based on the empiric administration of different blood products (e.g.~     platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic~     agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g.~     thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better~     assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While~     TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical~     impedance and related changes during clot formation, T2MR, a miniaturized, magnetic~     resonance-based diagnostic platform, measures how water molecules react in the presence of~     magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will~     prospectively collect demographic data, surgical characteristics, the amount of~     perioperative bleeding and blood product transfusion, results of laboratory assays, and~     postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our~     current practice, and develop an algorithm-based approach for the administration of targeted~     blood product and pro-coagulant therapies. Our goals are: the reduction of blood product~     utilization, the reduction of the incidence of massive bleeding and postoperative~     thrombosis.~   "
49404|NCT02410460|"~     This study is a prospective, double-blind, randomized comparison study of different~     anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether~     post-operative side-effect profiles in patients undergoing elective cosmetic facelift~     surgery can be decreased through the use of propofol/ketamine anesthesia with bispectral~     monitoring (PKA-BIS) rather than general anesthesia, without increasing intra-operative~     time, side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift~     surgery performed by the principal investigator will participate.~   "
49405|NCT02410447|"~     Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that~     significantly reduce the quality of life of the patient. They often do not respond to~     conservative treatments or advanced wound managements. Focused and defocused extracorporeal~     shock wave therapy can be a viable alternative therapeutic strategy.~      The purpose of the study was to examine the effects of defocused extracorporeal shock wave~     treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound~     healing and pain control.~   "
49406|NCT02410434|"~     The specific objectives of this study are reduce stigma towards lesbian, gay, bisexual, and~     transgender persons in Swaziland and Lesotho, using performance ethnography at community~     roundtables.~   "
49407|NCT02410421|"~     Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for~     resistant depression, it still fail to remit up to 70% of these patients. We hypothesize~     that personalizing the procedure using functional MRI to better select dysfunctional regions~     and robotic coil placement to stimulate these regions homogeneously, will increase its~     efficacy. Individualized rTMS will be compared to traditional rTMS procedure and to~     trans-cranial direct current stimulation (tDCS).~      In this small proof of principle study our primary outcome measure will be the correction of~     the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary~     outcome measurements.~   "
49408|NCT02410408|"~     Adverse events are also the cause of suffering in health professionals involved (second~     victims). This study has the aim of design and evaluates two applications for staff of~     hospital and primary care settings with the intention of improving their capacity to conduct~     Root Cause Analysis (RCA) and to help them introducing patient safety certification (PSC).~      A single-blind randomized controlled trial shall conduct with a control and an experimental~     group (N=84) in both cases. The characteristics of both apps shall specify based on the~     suggestions of health professionals and shall design for Android and IOS (for iPhone or~     Ipad).~      The randomly subjects in the control group shall receive oral and written information and~     the experimental group used App for two months. Pre- and post- measures shall include:~     patient safety knowledge and culture and self-perceived capacity to enhance RCA or follow-up~     PSC. In the experimental group, data shall also collect on their previous experience with~     information and communication technologies, their rating of each App. The inter-group~     intervention effects shall calculate by univariate linear models and ANOVA, with the pre- to~     post-intervention differences as the dependent variables.~   "
49414|NCT02410330|"~     In acute coronary artery disease, pre-clinical studies have indicated that, during a~     continuous infusion of intravenous perfluorocarbon containing microbubbles, the ultrasonic~     power delivered from a diagnostic ultrasound transducer is capable of restoring~     microcirculatory flow and improving epicardial recanalization rates obtained by conventional~     therapy, a process known by Sonothrombolysis. The investigators proposed to examine the~     feasibility, safety and efficacy of such an ultrasound guided approach in 100 patients with~     ST segment elevation myocardial infarction (STEMI).~   "
49415|NCT02410317|"~     The cesarean section is one of the most commonly performed surgeries in the world and it~     represents 20% of the births in France. Postoperative pain is moderate-to-severe during the~     first 48 hours after this procedure. Thereby its control is prominent for the medical team~     in order to shorten the duration of hospital stay as well as to permit an early return to~     daily activities for these surgical patients.~      Pain control after cesarean section is usually based on non-opioids and epidural~     administration of morphine if an epidural catheter has been previously placed for the~     procedure. However epidural morphine is associated with a number of side effects. Wound~     infiltration with local anesthetics has been widely used in the multimodal management of~     postoperative pain and it may reduce postoperative morphine consumption.~      In patients enrolled for emergency cesarean delivery with epidural catheter, the objective~     of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours~     infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia~     (epidural morphine bolus). Quality of pain control will be assessed with the measurements of~     morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3~     months, patients will be interviewed to assess their residual pain and their satisfaction.~      It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural~     morphine analgesia to control pain after cesarean section, and be associated with a~     reduction of side effects related to the analgesics.~   "
49416|NCT02410304|"~     This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D)~     concerning the rheumatoid arthritis in order to monitore the treatment. This study will~     provide the exact number of patients in remission according the 3 methods.~      It could allow to assess the concordance between the 3 evaluated methods. This study will~     permit to define the best method which limit the evolution of structural damages ( principal~     criteria).~   "
49417|NCT02410291|"~     Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate~     cancer. The dose volume constraints that predict for rectal toxicity require minimizing~     prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and~     internal organ motion during prostate IMRT increases risk of PSA failure in patients with~     large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial~     .The literature is limited regarding the effectiveness of educational intervention with~     behavioral reinforcement for patients, and a gap if exists literacy level is considered.~     Patients often cannot comprehend verbal or written instructions and have difficulties~     following through with recommended regimens.23 Using multimedia such as Internet,~     audio-visual media such as DVD and even the telephone can enhance patients' knowledge and~     understanding about importance of preparation for IMRT for prostate ca. Thomas's study~     showed that in patients undergoing radiotherapy and chemotherapy, the video group had lower~     anxiety scores compared with the non video group. At SOCC patients have been provided with~     verbal information about bladder and rectum preparation for prostate planning CT scan and~     IMRT. Patients should have a fullish bladder and empty rectum at the time of CT~     simulation. If the rectal diameter is > 4cm, the patient will be asked to empty his~     stool/gas and re-scanned. The 3- months review of patients preparedness for prostate IMRT~     showed that only 13/55 patients were adequately prepared but 42/55 (76%) of patients needed~     to be re-scanned due to inadequate bladder (21/42, 50%) or rectum filling 28/42, 67%) .~     Also, 2/13 (15%) patients were still not prepared at the second resimulation despite that~     they received a phone call with the instructions. The investigators plan to investigate if a~     multimedia education strategy will decrease costly resimulation rate for patients with~     prostate cancer.~   "
49418|NCT02410278|"~     The primary objective of this study is to evaluate whether montelukast can reduce the~     severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating~     Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with~     relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as~     follows: To evaluate whether montelukast after oral administration of DMF in participants~     with relapsing forms of MS decreases discontinuations due to GI events and reduces the~     number of participants taking symptomatic therapies for GI events; To investigate the effect~     of montelukast on the incidence of flushing events after oral administration of 240 mg DMF~     in participants with relapsing forms of MS.~   "
49419|NCT02410265|"~     This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy,~     feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and~     unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian~     university students. The investigators aim to assess if these novel electronic health~     (eHealth) interventions can be integrated into Indian university systems to increase access~     to efficacious, less stigmatized, and cost-effective mental healthcare.~   "
49420|NCT02410252|"~     This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous~     temperature monitoring device, as a clinical support and patient self-management tool in the~     management of pediatrics patients on myelosuppressive therapies for acute leukemia and other~     childhood cancers.~   "
49421|NCT02410239|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal~     stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).~   "
49422|NCT02410226|"~     The study will assess the benefit of using spinal ultrasound before epidural catheter~     insertion compared to the conventional palpation technique in women undergoing cesarean~     section.~   "
49423|NCT02410213|"~     This is a Phase II, open-label, non-randomized, multi-center, single arm study to~     characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric~     Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or~     15 mg/kg dose of Ferric Carboxymaltose.~   "
49424|NCT02410200|"~     The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate)~     on brain magnetic resonance imaging (MRI) lesions in pediatric subjects with~     Relapsing-Remitting Multiple Sclerosis (RRMS). The secondary objectives of this study are as~     follows: To characterize the pharmacokinetics (PK) of BG00012 in pediatric subjects with~     RRMS; To evaluate the safety and tolerability of BG00012 in pediatric subjects with RRMS.~   "
49432|NCT02410096|"~     The purpose of this study is to investigate the bronchial inflammation and~     hyperresponsiveness after oil supplementation. Before and after oil supplementation the~     investigators measure decrease in lung function after exercise-challenge in a cold chamber~     and increase of inflammatory markers in the blood.~   "
90817|NCT01868490|"~     Cytokine-induced killer (CIK) cells exhibit high proliferation rate and cytotoxic activity~     in vitro. The major effector cells are the CD3+CD56+ subset. The cytolytic activity of CIK~     cells being independent of MHC restriction implies feasibility in using CIK cells allogeneic~     to the tumors. Experiments to block the MHC class-I and -II pathways on tumors-RNA~     transfected DCs showed that only MHC class-I blocking led to a significant reduction of~     heterogeneous CIK cells cytotoxicity after the co-culture. The safety of CIK cells was~     demonstrated by the lack of cytotoxicity toward autologous as well as allogeneic normal~     cells. Co-culture of CIK cells with dendritic cells (DCs) has been reported by us and others~     in a myriad of cancer (e.g., cholangiocarcinoma, osteosarcoma, glioblastoma multiforme,~     multiple myeloma, hepatocellular carcinoma, pancreatic carcinoma, renal & colon carcinoma,~     murine leukemia & lymphoma showing enhancement of anti-tumor cytotoxicity of CIK cell in~     all. The co-culture of CIK cells with DCs were reported to decrease the number of~     professional regulatory/ suppressor T cells (Treg, CD4+CD25+ cells) and decrease the~     secretion of IL-10, an immune suppressor cytokine, whereas the cytotoxic activity against~     target cells increased.~      We have recently brought CIK cells through the preclinical phase (animal study) of human~     cholangiocarcinoma treatment. Cholangiocarcinoma (CCA), is a bile duct epithelial cancer~     endemic in the Northeast of Thailand, with an increasing incidence discernible in Europe and~     North America. Conventional treatments including surgery, chemotherapy, and radiation do not~     bring satisfactory survival due to anatomic location, presence of metastases, and high~     recurrent rates. These unsatisfactory outcomes urge to search innovative treatments such as~     immunotherapy. We reported the safety and efficacy of CIK cells in SCID mice model for~     cholangiocarcinoma. Several conditions of human CIK cells were examined using ex vivo~     cytotoxic assay and SCID mice pre-inoculated with human cholangiocarcinoma cells. We~     monitored the ex vivo cytotoxicity, tumor sizes and immunohistochemistry. Optimal tumor~     suppression was observed when CIK cells were pre-exposed to dendritic cells (DCs).~     Tumor-infiltrating human CD3+ cells were observed from day 2 - 14, but not in normal tissues~     elsewhere. These altogether indicated the specific homing of CIK cells to tumor mass. All~     animals did not exhibit any noticeable adverse reaction from the CIK treatments. The~     CD3+CD56+ cells are logical candidates for clinical trial while the DC-co-cultured CIK cells~     produced similar efficacy and more feasible for clinical application.~      With a complete array of in vitro and in vivo study, the next rational step is moving~     forward to phase I/II clinical trials for a number of specified solid tumors (i.e.,~     cholangiocarcinoma, osteosarcoma, and glioblastoma multiforme, nueroblastoma) using the~     optimized autologous CIK cells. Subjects without prior exposure to or weaned for at least 3~     months from chemotherapy can be recruited to maintain the integrity of their immunological~     system, a critical factor for a successful immunotherapy.~   "
49425|NCT02410187|"~     Clinical experience has shown that metastasis can often be limited in number and location,~     and thus amenable to local treatment. The term oligometastasis describes an intermediate~     state of cancer spread between localized disease and widespread metastasis. The implication~     of such an intermediate state is that the disease can be cured by using metastasis-directed~     therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical~     resection was often indicated, as abundant evidence suggested it could improve~     progression-free or overall survival. Recently, several studies have reported promising~     outcomes of >80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with~     lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver,~     non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have~     limitations of a retrospective nature and small sample sizes.Because allmost studies are~     based on single-arm studies without appropriate controls, the level of evidence to support~     SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for~     oligometastatic disease.~      This study is designed as a randomized phase II study. Patients will be randomized between~     current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known~     disease.~   "
49426|NCT02410174|"~     The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic~     body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma~     (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard~     treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available,~     but are highly invasive and are associated with significant side effects. SBRT is a~     non-invasive, non-surgical treatment that requires tumor immobilization and image guidance~     in order to deliver a very precise, high-dose treatment. This trial will assess the use of~     SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity.~     Subjects enrolled in this study will then be followed and evaluated for toxicity, serum~     chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans~     to assess the functionality of their renal tissue.~   "
49427|NCT02410161|"~     Background: As the main alternative fuel to glucose for the brain, increased plasma ketones~     could potentially help compensate for brain glucose hypometabolism occurring during aging.~     The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is~     normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in~     humans.~      Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in~     young and older healthy adults.~      Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2~     g/d of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin~     will be measured over 6 h during two metabolic study days, one before and one at the end of~     the supplementation.~      Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.~   "
49428|NCT02410148|"~     Glaucoma remains a disease with an unclear and complex underlying pathophysiology. Recently,~     researchers have emphasized not only intraocular pressure (IOP) or vascular dysregulation,~     but also translaminar pressure's (TPG) role in glaucoma (TPG=IOP-ICP). A higher TPG may lead~     to abnormal function and optic nerve damage due to changes in axonal transportation,~     deformation of the lamina cribrosa, altered blood flow, or a combination thereof leading to~     glaucomatous damage. However only invasive ICP measurements are available within the~     contemporary medicine. The ideas for non-invasive ICP measurement have been approached since~     about 1980. Most of the proposed technologies were based on ultrasound and were capable of~     monitoring blood flow in intracranial or intraocular vessels, cranium diameter, or acoustic~     properties of the cranium. Broad research has extended into sonography of optic nerve sheath~     and its relation with elevated ICP. However, most of these correlation-based methods had the~     same problem—the need of individual patient specific calibration. Seeking to measure~     absolute ICP values, researchers from Kaunas University of Technology created a non-invasive~     method, which does not need a patient specific calibration. The method is based on direct~     comparison of ICP value with the value of pressure Pe that is externally applied to the~     tissues surrounding the eyeball. Intracranial segment of ophthalmic artery (OA) is used as a~     natural sensor of ICP and extracranial segment of OA is used as a sensor of Pe. The special~     two depth transcranial Doppler (TCD) device is used as a pressure balance indicator when ICP~     = Pe.~      The aim of our study is to assess TPG in patients with primary open open-angle glaucoma~     (POAG). In addition the investigators want to measure ICP in patients with papilledema (PE)~     in order to compare them with glaucoma patients.~   "
49429|NCT02410135|"~     The objective of this exploratory pilot study is to assess whether Mirabegron (Myrbetriq™)~     will improve the quality of sleep and Lower Urinary Tract Symptoms (LUTS) in men and women~     presenting with LUTS and disordered sleep.~   "
49430|NCT02410122|"~     While a fair amount of clinical data on Stargardt disease type 1 (STGD1) have been~     published, very little is known about Stargardt disease type 4 (STGD4). The ProgStar 04~     study is an important opportunity to leverage the infrastructure, clinical trials sites,~     methods, and central reading center of the ProgStar program to investigate the progression~     of STGD4 and will help to establish patient cohorts worldwide for future clinical trials.~   "
49431|NCT02410109|"~     Perinatal depression is a significant concern, particularly for low-income women. Many cases~     of perinatal depression are complicated by comorbidities such as post-traumatic stress~     disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health~     services to women in home visiting programs could have considerable public health~     significance. This study will develop and test an integrated model of mental health services~     embedded within home visitation (HV) programs. This model will (1) incorporate a protocol~     for systematic screening and referral; (2) strengthen formal linkages between HV programs~     and other components of service systems; (3) promote the capacity of service systems to~     provide evidence-based early intervention and treatment for depression; and (4) facilitate~     the receipt of early intervention and treatment services for perinatal depression and~     comorbid conditions. This will be the first model to our knowledge that systematically~     integrates screening, referral, and early intervention and treatment for perinatal~     depression and associated comorbidities within HV programs.~      The specific aims are:~        1. To develop an integrated model of perinatal depression care within HV programs. This~          integrated model (SCRIPT) will incorporate screening, referral, and individualized~          prevention and treatment services.~        2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV~          programs. One HV program—DRUM Healthy Families—will use paraprofessionals as~          interventionists while the other program—M&I Nursing—will use nurses and social workers~          as interventionists.~        3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive~          episodes.~   "
49433|NCT02410083|"~     The purpose of this study in to evaluate efficacy and tolerability of Clopirin and~     clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery~     intervention.~   "
49434|NCT02410070|"~     The objective of this study is to compare a minimal invasive approach with the conventional~     flexor carpi radialis approach for volar plating of distal radial fractures.~   "
49435|NCT02410057|"~     Formula composition has developed to resemble breast milk as close as possible, but there~     are still considerable differences between formula and breast milk composition, probably~     resulting in higher risk of overweight in childhood and higher incidences of infections in~     formula-fed infants. Protein levels are still higher and constituents such as~     alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to~     formula, rich in tryptophan, the resulting amino acid composition will allow further~     reduction of protein in formula. The investigators intend to include 320 infants, where 80~     will be exclusively breastfed and the remainder assigned in a double blind, controlled,~     randomized manner to one of three formula groups; two experimental, protein reduced formula~     with two different levels of alpha-lactalbumin and one group given standard infant formula.~     The intervention period is from 4-8 weeks until 6 months of age. The infants will be~     followed by growth parameters, blood-, urine- and fecal biomarkers and health parameters~     until 5 years of age. The experimental formula will possibly result in growth, metabolism~     and gut microbiota as well as health parameters more similar to those of breastfed infants~   "
49436|NCT02410044|"~     Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life~     patients with bone metastases treated with osteoprotective agents.~   "
49437|NCT02410031|"~     The study will be an observational, cross-sectional study of knowledge, understanding, and~     self-reported behavior among a sample of physicians with recent experience in prescribing~     Diane-35 or its generics in a total of five European countries. The primary objective of~     this study is to measure physician knowledge and understanding of the key information~     contained in the Diane-35 educational material: Patient information card, and Prescribers'~     Checklist.~      Specifically, the following objectives will be addressed:~        -  Investigate whether physicians have received any educational material related to~          Diane-35 or its generics~        -  Assess physicians' knowledge and understanding of key safety information pertaining to~          the patient information card~        -  Assess physicians' knowledge and understanding of key safety information pertaining to~          the following areas:~        -  Contraindications relevant to thromboembolism~        -  Risk factors for thromboembolism~        -  Signs and symptoms of thromboembolism~   "
49438|NCT02410018|"~     This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of~     uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for~     hysterectomy.~   "
49439|NCT02410005|"~     This study is a single center open-label randomized controlled trial designed to evaluate~     the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and~     macroalbuminuria.~   "
49440|NCT02409992|"~     The proposed research will focus on the development of a brief emotion-coaching (EC)~     parenting program (which directly targets child emotion awareness/recognition and affective~     empathy), that will be combined with a well-established parent management training program~     (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in~     children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous~     use of others).~   "
49441|NCT02409979|"~     Room air insufflated during colonoscopy cannot be completely suctioned, is not easily~     absorbed and remains in the bowel for quite some time, resulting in prolonged bowel~     distension with the discomfort of bloating. Sufferers often experience a sensation of~     fullness and abdominal pressure, relieved only after expulsion of the residual gas, often~     accompanied by colic pain. This can be a lengthy process, and some patients continue to~     report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy~     is an adverse event commonly reported by patients, and definitely associated with the~     procedure. Published reports show that the use of carbon dioxide (CO2) insufflation~     significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results~     of the investigators' previous study about on-demand sedation colonoscopy in diagnostic~     patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion~     of water to distend the lumen during insertion; suction of infused water, residual air~     pockets an feces predominantly during insertion) achieved significantly lower real-time~     insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating~     scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.~     Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher~     bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences~     were significant only at discharge. The investigators decided to conduct a prospective~     randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test~     the hypothesis that patients examined by the combination of WE-CO2 will have significantly~     lower bloating scores at specific time points after colonoscopy than those examined using~     WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on~     patients comfort and activities in the post-procedure period.~   "
49442|NCT02409966|"~     There are different protocols to treat gum diseases. One relevant differential aspect is~     related to time. There are protocols that usually takes one to two months to be completed~     while other are completed within 24 hours. Although both protocols seem to provide~     clinically similar improvements, there are some positive aspects related to the short-term~     one. Among them lower number of clinical sessions, easier schedule and costs advantages.~     However, there are many other relevant aspects that can be helpful for patients and~     clinicians decisions regarding type of treatment.~      This study evaluates if and how clinically effective protocols used to treat periodontitis~     affect quality of life related to individual's oral statuses. In addition, the experiences~     of fear, anxiety and pain before and after these specific protocols are monitored.~   "
49443|NCT02409953|"~     Like in the full immersion, studied in the context of diving, immersion in water causes a~     cascade of events with hemodynamic and hormonal consequences.~      First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60~     minutes later, hypovolemia by stimulating diuresis.~      Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.~      However, when the labor progresses, the dilatation bath is no longer sufficient and epidural~     analgesia remains the only effective method to control pain.~      Used before the realization of an epidural analgesia, dilatation bath could affect blood~     volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked~     to the installation of sensory block of the epidural analgesia in the parturient (severe~     prolonged maternal hypotension that can cause a decrease of the placental perfusion and~     fetal distress).~      Before beginning a study in pregnant women, it seems essential to study the hemodynamic~     consequences of the dilatation bath in a comparable population of volunteers healthy young~     women and out of the obstetrical context.~   "
49653|NCT02407210|"~     To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in~     patients with grade I or II essential hypertension~   "
51135|NCT02387801|"~     To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque~     psoriasis and to document the same using sequential photographic images.~   "
49444|NCT02409940|"~     Despite being a miracle of modern medicine, solid organ transplant recipients are always at~     risk of rejection, and remain dependent on lifelong immunosuppression. Currently used~     immunosuppressive drugs suppress the potential of immune system and interfere with the~     metabolism of medications. Cellular therapies currently being investigated for this purpose~     require the use of ablative radiotherapy. The investigators are using a less toxic strategy~     by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx)~     recipients and studying immunomodulation mediated by these cells in the KTx patients.~      Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and~     Dendritic cells which leads to improve graft survival of renal transplant patients.~      Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated~     response.~      The investigators aim to collect peripheral blood from 30 patients (10 patients for~     autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time~     intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but~     without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear~     cells and performing various immune assays on these cells in a donor specific response.~   "
49445|NCT02409927|"~     Lower brain glucose uptake is present before the onset of cognitive deterioration and may~     increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main~     alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized~     and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due~     to incomplete absorption so the investigators examined whether homogenisation into a skim~     milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT~     taken without homogenisation into a matrix (bulk MCT [MCT-B]).~      Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in~     higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and~     MCT-H on ketogenesis will be dose-dependent.~   "
49446|NCT02409914|"~     The purpose of this study is to investigate whether higher insulin resistance in young women~     with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of~     glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative~     cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained. The~     potential relationships between anatomical and functional cerebral parameters and insulin~     resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).~   "
49447|NCT02409901|"~     This randomized controlled trial (RCT) will examine the effect of a novel 12 month~     personalized exercise rehabilitation program compared to standard care following kidney~     transplantation. Return to work or find work rates, markers of subclinical atherosclerosis,~     functional capacity, body composition, quality of life, kidney function, and adherence to~     exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise~     rehabilitation program will increase the return to work or find work rate in kidney~     transplant recipients. The investigators additionally hypothesize that a 12 month exercise~     rehabilitation program will prevent a decline in subclinical atherosclerosis, increase~     functional capacity, and increase lean muscle mass.~   "
49448|NCT02409888|"~     The purpose of this study is to investigate how behavioral treatments for alcohol use~     disorders affect behavior change.~   "
49449|NCT02409875|"~     This is a cohort study where families with infants are followed closely for three years. It~     aims to assess if parental weight status (normal weight vs. overweight/obesity), their~     physical activity and eating habit will influence their young children's growth and be~     helpful in childhood obesity reducing.~   "
49450|NCT02409862|"~     The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine~     contractions has been shown to be involved in many of the social capacities that seem to~     change with age, such as emotion detection and identification, enhanced social memory,~     empathy, and trust. Thus, age-related changes in the OXT system may underlie differences~     between young and older adults in socioemotional functioning. Research on the effects of~     oxytocin in aging is very scarce; therefore, the purpose of this research project is to~     determine the effects of oxytocin on socioemotional aging. The aim of this research is to~     examine the behavioral and neural effects of OXT on decisions of trust in social~     interactions, perceptions of facial trustworthiness, the ability to read faces, and levels~     of empathy with other people in samples of young and older adults.~   "
49451|NCT02409849|"~     This is phase II study on the efficacy of octreotide lar as maintenance treatment after~     first-line chemotherapy for patients with unresectable or metastatic~     gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.~   "
49452|NCT02409836|"~     The objective of this study was to examine the amount of dentifrice ingested and used by~     various age groups of children.~   "
49453|NCT02409823|"~     Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been~     found to be effective and safe for the treatment of schizophrenia, bipolar disorders,~     depressive episodes associated with bipolar disorder, or psychotic symptoms in the context~     of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors,~     at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among~     others. Quetiapine extended-release has the same clinical efficacy as the immediate-release~     formulation, but reduces the amount of daily doses, possibly contributing to increased~     treatment adherence.~      The purpose of this registry is to explore adherence to treatment, the occurrence of adverse~     drug reactions and the clinical outcomes in a sample of patients under treatment with~     atypical antipsychotics in several Central American countries. For this study, clinical data~     will be extracted from the medical records of 1000 patients with schizophrenia, depressive~     disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions,~     namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic~     hypotension; adherence to treatment; and changes in quality of life and clinical status will~     be assessed during the first 8 weeks of treatment.~   "
49531|NCT02408809|"~     The investigators of this study aim to evaluate the impact of a new orthopaedic related~     smoking cessation discussion on smoking behavior. Considering the high prevalence of~     patients who smoke and receive orthopaedic management, we are interested in determining~     whether an orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy~     over time compared to a general smoking cessation discussion.~   "
51589|NCT02381886|"~     A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132~     mutations.~   "
49454|NCT02409810|"~     The primary aim of this pilot study is to establish the safety and feasibility of~     patient-controlled administration with dexmedetomidine for anxiolysis (PCA-DEX) during burn~     care dressings for patients with burn injury. The secondary aim is to determine the~     acceptability of PCA-DEX for anxiety symptom management by patients with burn injury and~     nursing staff caring for these patients. Objectives Primary Aim #1 Safety: To examine the~     safety of PCA-DEX as determined by the proportion of patients successfully completing the~     pilot trial without adverse effect which include significant hypotension, bradycardia, or~     agitation from uncontrolled anxiety. Primary Aim #2 Feasibility: The primary objective of~     this study is to establish feasibility of subject recruitment and protocol adherence in a~     pilot study of PCA-DEX in patients with burn injury requiring dressing changes. Feasibility~     will be defined by the following criteria: a) number and proportion of patients who consent~     to enrollment, b) proportion of eligible subjects enrolled prior to first dressing change,~     c) number of days on protocol that patients successfully use the PCS device, d) ability of~     burn nurses to adjust the pump and adhere to the infusion rates of the PCA-DEX protocol.~     Secondary Aim #1 Patient Acceptability: A secondary objective of this pilot study is to have~     patients evaluate PCA-DEX in regards to patients' willingness to use PCA-DEX prior to and~     during burn dressing changes to self-manage anxiety and their satisfaction ratings with~     anxiety self-management. Secondary Aim #2 Nurse Acceptability: Another secondary aim of this~     pilot study is to evaluate the nursing staffs' acceptability of the PCA-DEX protocol for~     patients' to self-manage anxiety surrounding burn care dressing changes. Hypotheses #1:~     PCA-DEX protocol will be safe to administer during burn care dressing changes. #2: PCA-DEX~     will be feasible to implement on the Burn Center at OSUWMC. #3: Patients will favorably~     appraise PCA-DEX for the self-control of anxiety associated with burn care dressing changes,~     and be satisfied with PCA-DEX for the management of anxiety. #4: Nursing Staff will~     favorably appraise PCA-DEX while performing burn care dressing changes.~   "
49455|NCT02409797|"~     The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during~     the delivery of a specific, manually based chiropractic treatment for participants with low~     back pain.~   "
49456|NCT02409784|"~     Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of~     aging-related cognitive impairment in humans. Ketones are the main alternative energy~     substrate to glucose for the brain. Several studies show that brain ketone uptake and~     metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease~     (AD). Nutritional ketosis is reported to have a positive impact on cognitive performances in~     mild cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone~     uptake in adults are poorly understood during diet-induced experimental ketosis. The~     investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be~     directly correlated with the elevation of blood ketone levels and inversely correlated to~     brain glucose uptake.~   "
49457|NCT02409771|"~     The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON~     Presbyopic.~   "
49458|NCT02409758|"~     The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive~     Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.~   "
49459|NCT02409745|"~     Many studies have demonstrated that endometrial scratch significantly increase pregnancy~     rate in patients undergoing in vitro fertilization and embryo transfer. However, only a~     limited number of studies have been conducted in frozen thawed transfer (FET) cycle.~     Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time~     points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current~     cycle. However, few studies have compared the effectiveness of those two different~     endometrial scratch methods performed in different timing. The aim of this study is to find~     the best timing of endometrial scratch in FET cycles.~   "
49460|NCT02409732|"~     To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the~     treatment of actinic cheilitis.~   "
49461|NCT02409719|"~     The investigators include patients attending the outpatient clinic in the area of~     Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee~     osteoarthritis, which treatment requires surgery. Patients will be divided into two groups.~     In both groups, they will be given verbal, clear and detailed information on the approach to~     follow, the exercises given in brochures, and in the study group a schedule will be given in~     order to record rehabilitation exercises in patients after total knee replacement (TKA).~     Both groups will be assessed before and after surgery, together with outpatient follow-up~     by, WOMAC, Visual Analogue Scale and SF-12.~   "
49462|NCT02409706|"~     This study aims to explore the frequency and types of micronutrient deficiencies in a sample~     of UK children with CHD using standard and novel markers in blood. The study will also~     explore whether micronutrient deficiencies increase the risk of complications after heart~     surgery. This study will identify any nutrient deficiencies that need monitoring in clinical~     practice.~   "
49463|NCT02409693|"~     This is a retrospective chart review. The purpose of this study is to retrospectively~     examine the use of perioperative analgesics on the incidence of postoperative pain and~     emergence delirium in patients undergoing bilateral myringotomy with tube insertion (BTI),~     as well as events associated with treatment including postoperative vomiting and time to~     discharge.~   "
49464|NCT02409680|"~     Available data suggest that low dose aspirin may be a safe, widely available and inexpensive~     intervention that may significantly reduce the risk of preterm birth. However, this~     possibility needs to be proven in a properly designed randomized controlled trial (RCT) with~     preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and~     geographically diverse population could best be accomplished by the established~     infrastructure of the Global Network for Women's and Children's Health Research (GN).~   "
49465|NCT02409667|"~     To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg~     s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg~     s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.~   "
49466|NCT02409654|"~     Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In~     'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be~     difficult because AF may be present without symptoms and intermittent in nature.~     Furthermore, utilization of adequate oral anticoagulation therapy (OAC) for stroke~     prevention is suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence~     of stroke. The latest European guidelines recommend opportunistic screening for people >=65~     years by pulse palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained~     technician, time consuming, requires the patient to lie on an examination couch and is not~     readily available in most outpatient clinics in Hong Kong. A practical screening test is~     needed. Our study aims to evaluate the feasibility, acceptability and incremental cost of an~     outpatient based AFscreening program using the AliveCor device. Newly diagnosed AF patients~     will be randomized to routine care versus individualized stroke prevention strategy which~     consists of patient education, stroke and bleeding risk assessment, evidence-based OAC~     recommendation, patient audit and follow-up to improve OAC utilization for stroke~     prevention. We envisage this study will provide timely evidence to inform policy decisions~     concerning population-based AF-screening for AF for stroke prevention.~   "
49467|NCT02409641|"~     The WHO, states that age related cataracts account for 51 percent of worldwide blindness and~     affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the~     first line treatment for cataracts, thus there is an on going effort to improve IOL design~     and performance.~      It is planned to compare three different IOL designs in a psychophysical test setting. Most~     IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study~     (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow~     testing a more real-life situation.~      As various downsides of different IOL designs have been reported, testing of IOLs before~     surgical implantation is a promising approach to maximise patient satisfaction. Known~     deficiencies include amongst others reduced contrast sensitivity or light intensity.~      To test three different IOL designs, it is planned to have 2D healthy young subjects look~     through a stable, table mounted spectacle frame, in which the different IOLs can be~     inserted. This allows for subjective testing of IOL's in a 2D and 3D scenario.~   "
49468|NCT02409628|"~     The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair~     Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical~     removal of non-melanoma skin cancers.~      EktoTherix™ is a medical device developed by Neotherix Limited, described as a tissue~     scaffold, that is placed into the surgical wound to help the patients' own cells repair the~     wound, enhancing healing and improving quality (including cosmetic outcome). The tissue~     scaffold is completely absorbed by the body during the healing process, which means that~     there is no need to remove it when the wound is healed.~      All patients recruited into this study are treated with EktoTherix, are seen weekly until~     they heal and seen again at the final follow-up visit three months post-surgery.~      The investigators hypothesise that the use of EktoTherix will increase incidence of complete~     healing and result in an overall better cosmetic result of the healed wound.~   "
49469|NCT02409615|"~     In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing~     touch as adjunct therapies to the standard of care, will improve analgesic use for post~     operative pain. In this pilot study the investigators will randomize 45 adolescents~     undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain~     Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of~     Care, and a control group (Pain Management Standard of Care only).~   "
49470|NCT02409602|"~     Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery~     ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women~     were performed regularly in the postoperative period, in order to evaluate possible effects~     of BIIAL on clitoral blood flow.~   "
49471|NCT02409589|"~     The purpose of this study is to compare a new intracavitary ECG guiding method for real-time~     positioning the tip of three-way valve type peripherally inserted central catheters versus~     conventional surface prediction length method in terms of single-time target rate.~   "
49472|NCT02409576|"~     Progress in the treatment of children with leukemia and lymphoma results in high cure rates~     but progress in the treatment of children and adolescents with solid tumors has been slow.~     Despite aggressive therapy with multimodality treatment involving surgery, radiation and~     chemotherapy, about two thirds of the patients with metastatic Ewing sarcoma (EWS),~     metastatic osteosarcoma (OS) and intermediate and high risk rhabdomyosarcoma (RMS) will~     relapse. The available second line therapies for relapse are limited and often not~     effective. There is a dire need to look for treatment options beyond conventional means for~     the treatment of these patients.~      Infusions of allogeneic natural killer (NK) cells in leukemia patients have shown to be~     tolerated well without inducing graft versus host disease (GVHD). There is also mounting~     evidence that NK cells have activity against solid tumors.~      In the lab the investigators tested NK cell activity against cell lines from different~     paediatric solid tumors. Among paediatric solid tumors, EWS and RMS are exquisitely~     sensitive to killing by expanded NK cells; NK cells also have activity against OS cells.~     Preliminary clinical data suggest that donor NK cells may exert antitumor activity in~     children with solid tumors undergoing allogeneic hematopoietic stem cell transplantation.~      Taking into account the safety of adaptive NK cell infusion, and their efficacy against EWS,~     RMS and OS, NK cells could be a powerful new tool in the treatment of paediatric solid~     tumors.~      The great anti-tumor activity of expanded and activated NK cells, together with the~     feasibility of infusing haploidentical NK cells in a non-transplant setting form a~     compelling rationale for the clinical testing of these NK cells in patients with sarcoma.~   "
49473|NCT02409563|"~     In clinical trials for treatment of allergic rhinitis a significant reduction of the total~     symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous~     results in adults show that the assessment and monitoring del nasal fractional exhaled~     nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.~      Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous~     solution) on the nasal inflammation marker (nFeNO).~      Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total~     Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported~     sleep quality (Pittsburgh Sleep Quality Index, PSQI).~   "
49474|NCT02409550|"~     This project is an observational study for the Italian language validation of the CARATKids~     questionnaire investigating the asthma and coexisting allergic rhinitis control in children.~     113 patients with concomitant asthma and allergic rhinitis followed up from at least 3~     months will be enrolled for the validation process at outpatient clinic of Pediatric~     Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the~     Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council~     (CNR) of Palermo (RDRC-IBIM CNR), Italy.~      The study will be completed in two medical examination, within 3-6 weeks of each other.~      CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control~     Test) will be filled by each patient.~      The main outcome is the Italian language validation of the CARATKids questionnaire~     investigating the coexisting asthma and allergic rhinitis control in children.~   "
49532|NCT02408796|"~     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with~     either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible~     subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is~     designed to characterize safety, procedural factors and clinical effect of OTO-201~     administered in subjects with AOMT.~   "
49475|NCT02409537|"~     Background & Aims: The role of red wine in cardiovascular risk prevention has been~     documented by several epidemiological studies in patients and normocholesterolemic healthy~     individuals. However, it is unclear whether hypercholesterolemic individuals free of~     cardiovascular disease would equally benefit from moderate red wine consumption to prevent~     atherosclerosis and the development of cardiovascular disease.~      Methods: Forty (40) healthy volunteers males and females were recruited, divided into 2~     age-adjusted groups according to their total cholesterol levels; in asymptomatic~     hypercholesterolemics (AHC ), and normocholesterolemics (NC ). Total Antioxidant Capacity~     (TAC ), Lipid profile, Vitamin E, and cardiovascular risk indexes ( LDL /HDL and Vitamin~     E/TC ) were evaluated in the blood serum of all subjects prior to and 1 month after once~     daily red wine consumption as well as prior to and after being given a placebo drink~     following a 1 month wash out period and resveratrol for 1 month after wash out period..~   "
49476|NCT02409524|"~     This is an open-label, single site, Phase II clinical trial to investigate the safety and~     efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients~     after a minimum of 90 days on sorafenib.~   "
49477|NCT02409511|"~     Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and~     non-diabetic subjects.~      However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either~     early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no~     biomarkers that permit us to discriminate between these two conditions.~   "
49478|NCT02409498|"~     The purpose of this study is to determine the effectiveness of perineal pain control via~     injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly~     used for this block is called marcaine. This is called a pudendal block it has been used in~     obstetrical and gynecologic surgeries for several decades. The goal of this study is to~     reduce the amount of pain medications taken post operatively after pelvic reconstructive~     surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the~     pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to~     document their pain score days 1 and 2 post op. They will also be asked to keep a medication~     log for 14 days post op.~   "
49479|NCT02409485|"~     By teaching skills to improve the coordination of care and support in couples coping with~     head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise~     for improving self-management, reducing costly hospitalizations and treatment interruptions,~     and improving both partners' quality of life. Home-based delivery will enhance future~     dissemination and outreach to those who do not have access to psychosocial services or live~     far away from their care centers. If found effective, the intervention may also have~     salutary downstream effects on the health and well-being of HNC patients and their partners.~   "
49480|NCT02409472|"~     Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their~     front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible~     for the trial and randomized to two different surveillance programs. These programs differ~     greatly in the frequency of diagnostic imaging. They have similar schedules of physical~     examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline~     and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are~     overall survival and QoL.~   "
49481|NCT02409459|"~     This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of~     iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1~     ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be~     followed for efficacy and safety for 42 days.~   "
49482|NCT02409446|"~     The purpose of this study is to examine weather treatment with anthocyanins will affect~     lipid profile, markers of inflammation and oxidative stress in addition to antioxidative~     level in serum to the better in persons with increased risk of dementia.~      The purpose of this study is to examine weather treatment with anthocyanins will increase~     the score of relevant tests of cognitive function.~      The investigators will do an open pilot study where patients receive anthocyanin for 16~     weeks.~   "
49483|NCT02409433|"~     The Investigator plans to perform a prospective, randomized, single blinded, study that will~     compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive~     Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident~     and sub-clinical seizures, and to compare long-term outcomes between patients treated with~     lacosamide and those treated with Phenytoin.~   "
49484|NCT02409420|"~     Chronic low back pain (CLBP) is very common and causes much pain and disability. It costs~     the NHS billions of pounds in treatment every year and is the second leading cause of time~     off work. There are various treatments for CLBP, but the most effective are still only~     moderately helpful. Most people with CLBP receive physiotherapy, with varying results.~     Cognitive behaviour therapy (CBT) may offer more long term help than current treatments~     because it enables people to self-manage their condition. A new type of CBT, called~     Acceptance and Commitment Therapy (ACT), has produced particularly good results for chronic~     pain. However, a shortage of clinical psychologists means that most patients never receive~     CBT. Physiotherapists can successfully use CBT techniques with extra training, but this is~     not standard practice and ACT-based physiotherapy treatment has never been tested.~      The investigators have developed a short ACT-based treatment (PACT) for physiotherapists to~     deliver and aim to compare it with usual physiotherapy care. The investigators will recruit~     240 people with CLBP from three hospitals in South East London. They will be randomly~     divided into two groups, with half receiving PACT and the other half ordinary physiotherapy.~     PACT consists of two hour long sessions and one follow-up phone call, meaning fewer hospital~     visits for patients and more time during sessions for individualised treatment. It aims to~     encourage people to focus less on getting rid of their pain and more on moving forward with~     what is most important in their lives. The investigators will compare PACT with usual~     physiotherapy to see which is most successful at improving people's ability to function and~     their quality of life and which approach helps them to manage their back pain best in the~     long term. If PACT is effective, the investigators believe it could reduce the considerable~     burden of CLBP to patients, the NHS and society.~   "
49530|NCT02408822|"~     Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia.~     Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial~     disease.~      This randomized controlled trial is designed to prove the superiority of a drug-eluting~     balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment~     of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.~      The hypothesis is that use of drug-eluting balloon will improve post-interventional patency~     of the access, and therefore, limit numbers and days of hospitalization for maintenance of~     hemodialysis vascular accesses.~   "
49586|NCT02408081|"~     The purpose of this study is to determine whether Family Focused Nursing are effective in~     the treatment of elderly medical patients with respect to prevalence of depression~   "
49485|NCT02409407|"~     The role of hysteroscopy in infertility investigation is to detect possible intrauterine~     changes that could interfere with implantation or growth or both of the conceptus, with the~     invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office~     setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention.~     It is currently acknowledged as the 'gold standard' investigation of the intrauterine~     abnormalities.~      Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force~     needed for dilation, thereby potentially reducing the probability of procedural complication~     such as uterine perforation, cervical laceration, failure to dilate, and creation of a false~     track that can occur during cervical entry.~      Misoprostol is a prostaglandin El analogue, that can be administered either orally or~     vaginally, that can cause cervical ripening by inducing collagenolytic activity and~     synthesis of proteoglycans.~   "
49486|NCT02409394|"~     This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag~     fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on~     the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.~   "
49487|NCT02409381|"~     Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288~     (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will~     be randomly allocated to one of two treatment groups , and treatment group 01 will be the~     dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment~     group 02 will ibuprofen (Alivium®).~   "
49488|NCT02409368|"~     The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades~     3-4), treatment-related, select adverse events in patients with advanced or metastatic~     Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or~     after at least 1 systemic therapy.~   "
49489|NCT02409355|"~     This randomized, open-label study is designed to evaluate and compare the safety and~     efficacy of Atezolizumab (MPDL3280A) compared with treatment with gemcitabine + cisplatin or~     carboplatin in patients with chemotherapy-naive, Stage IV squamous non-small cell lung~     cancer (NSCLC).~   "
49490|NCT02409342|"~     This randomized, open-label study will evaluate the efficacy and safety of atezolizumab~     compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per~     investigator discretion) combined with either pemetrexed (non-squamous disease) or~     gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected participants~     who are chemotherapy-naive and have Stage IV Non-Squamous or Squamous NSCLC.~   "
49491|NCT02409329|"~     Approximately one in three persons with diabetes are nonadherent to their medications.~     Nonadherence is more common among low income, racial/ethnic minorities with type 2 diabetes~     (T2DM), and is a strong, independent predictor of having poor glycemic control, being~     hospitalized, pre-mature mortality, and higher healthcare costs. Theory-based adherence~     promotion interventions are more effective than atheoretical, adhoc approaches, and are~     needed for patients at highest risk of nonadherence. A well-validated theoretical model, the~     Information—Motivation—Behavioral Skills (IMB) model, has informed effective medication~     adherence promotion interventions for patients with HIV and hypertension, and should inform~     adherence interventions in diabetes. Moreover, widely available technologies, such as mobile~     phones, offer a means to deliver adherence interventions to a broad range of patients,~     including low income, racial/ethnic minorities at high risk of nonadherence.~      The goal of this research is to use the IMB model to inform the content and functionality of~     a mobile phone-delivered medication adherence promotion intervention, ensure intervention~     content is clearly communicated (i.e., uses simplified text and plain language), and~     evaluate intervention effects on adherence and glycemic control among low-income adults with~     T2DM receiving primary care at Federally Qualified Health Centers (FQHCs).~      This interdisciplinary research will greatly enhance our understanding of how to address~     social-cognitive barriers to adherence among high-risk patients with diabetes, how to~     leverage mobile devices to support high-risk patient populations in general; and how to~     better design interventions to improve services for low-income, diverse patients, as well as~     other high-risk groups. Knowledge gained form this work may also inform interventions to~     reduce disparities in adherence, glycemic control, and other diabetes outcomes.~   "
49492|NCT02409316|"~     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate~     estrogen receptor (ER) activity in sites of metastatic disease using the investigational~     radiotracer [18F]fluoroestradiol (FES).~   "
49493|NCT02409303|"~     This project will implement and evaluate an innovative healthcare service delivery model~     designed to promote earlier access to specialized intervention for toddlers with ASD. The~     Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early~     identification and intervention by involving both medical and EI providers, and represents a~     practical and sustainable strategy for bridging the gap between ASD concerns and ASD~     intervention.~   "
49494|NCT02409290|"~     Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected~     person transmits their saliva through the air by coughing or sneezing. Despite the~     availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the~     worldwide control of this disease is currently being impacted by the emergence of multidrug~     resistant TB (MDR-TB).~      MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the~     two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while~     a person is taking TB treatment due to either inappropriate treatment or failure of patients~     to comply with their treatment. This strain of drug-resistant bacteria can also be spread to~     other people through the air.~      MDR-TB leads to a considerable reduction in the effectiveness of standard short-length~     treatments and currently the standard treatments for MDR-TB can last as long as 24 months.~     With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy~     duration of current treatments there is a need to investigate whether a shorter-length~     treatment using effective drugs is a global possibility.~      Three short course regimens of drugs will be evaluated alongside the World Health~     Organisation recommended 24 month regimen for the treatment of MDR-TB.~      A total of at least 1155 participants with MDR-TB will be recruited and followed for a total~     of 132 weeks.~   "
49522|NCT02408926|"~     Young infants are most vulnerable to severe disease and even death when infected with~     Bordetella pertussis. The current vaccines and vaccination programs do not guarantee~     protection of neonates from this disease. Maternal acquired pertussis-specific antibodies~     show low concentrations with short persistence in newborns creating a susceptibility gap for~     infection between birth and the first vaccinations. A possible strategy to protect infants~     from birth is pertussis vaccination during pregnancy, which will increase the amount of~     passively transferred maternal antibodies.~      However, little is known regarding the effect of high titers of maternal antibodies on the~     infants immune responses to different pertussis vaccines (whole cell versus acellular).~     Humoral immune responses will be assessed in infants receiving whole cell versus infants~     receiving acellular pertussis vaccines. Functionality of the antibodies will also be~     analyzed.~   "
49495|NCT02409277|"~     The investigators have developed a tool to facilitate asthma self-management in children,~     the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a~     new model that is continuous and proactive, focusing on prevention and control, rather than~     reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly~     monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning~     signs of asthma attacks in order to prompt appropriate interventions and timely visits to~     Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective~     patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a~     preliminary study of the paper-based version of the AT, frequent users had significantly~     fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot~     testing revealed that the tool was useful in helping them manage their child's asthma and~     were interested in assessing the tool's effectiveness and in identifying and addressing~     barriers to their sustained use of the e-AT.~      Improving asthma control in children will be facilitated by broad e-AT dissemination, and by~     identifying and addressing critical factors that contribute to parent sustained~     participation in self-management. The investigators propose to assess the effectiveness of~     the new ambulatory care model supported by the e-AT and conduct an e-AT process evaluation,~     assessing barriers and facilitators of sustained parent use. The investigators will engage~     parents throughout this study to identify and address themes that matter to them. The target~     population is children with persistent asthma, ages 2-17 years. The investigators have~     engaged 10 parents since conception of this project, from the planning to design and~     validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents~     was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and~     facilitated discussions to inform the development of this proposal including research~     objectives and outcome measures. In addition, the investigators have recruited other key~     stakeholders for whom the results of the research will be relevant.~   "
49496|NCT02409264|"~     In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia~     may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties,~     and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for~     insomnia includes both psychological and drug therapies. These conventional medications~     potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic~     treatment is a process in which a homeopath selects the most appropriate remedy for the~     treatment of a condition in accordance with the fundamental principles of homeopathy. This~     treatment protocol may offer safe and effective treatment for insomnia disorder, however,~     more research is required on the subject. The aim of this study is to determine the effect~     of individualised homeopathic treatment of insomnia disorder in females using detailed case~     studies and the Insomnia Severity Index.~   "
49497|NCT02409251|"~     The aim of this study is to assess the effect of a simple intervention (a combination of~     education and feedback) on Antinuclear Antibody (ANA) testing.~      This aim was chosen because of the known overuse of many laboratory tests, of which ANA~     testing is one. As overuse of ANA tests can have negative consequences (both for patients~     and society), the investigators designed an intervention to see how this would influence~     Antinuclear Antibody testing by rheumatologists.~   "
49498|NCT02409238|"~     Dementia (Alzheimer's Disease) is sometimes called Type 3 Diabetes because of the strong~     connection between Type 2 diabetes (a function of insulin resistance) with Dementia.~      The investigators therefore hypothesize that Reducing Insulin Resistance using Intensive~     Lifestyle Intervention (Exercise and Weight loss) + Metformin Treatment in Prediabetic &~     diet-control-only Diabetic overweight and mildly cognitively impaired individuals 55 years~     or older would lead to better Cognitive Function (compared to standard care) after 2 years.~      Subjects will be monitored and assessed using a battery of Cognitive and psychological tests~     and PET scans to demonstrate glucose utilization in the relevant areas of the brain.~      This 3-year open-label study aims to recruit 360 subjects with 50% (180 subjects) randomized~     to receiving Intensive lifestyle intervention with Metformin (if diabetic) vs the other 50%~     who would receive only the usual standard level of care in the primary care setting.~   "
49499|NCT02409225|"~     Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical,~     Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and~     technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting~     unnecessary visits in outpatient clinic, shortening time to medical intervention and~     therefore help to decrease hospitalization rate among those patients.~      The RESULT study primary endpoint of the trial will be a composite of all-cause death or~     hospitalization due to cardiovascular reasons.~      The primary technical endpoint is to construct and evaluate a unified and integrated~     platform for data collected from RM devices manufactured by different companies: Carelink™~     (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and~     Home Monitoring™ (Biotronik®, Berlin, Germany).~   "
49500|NCT02409212|"~     Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1)~     comparing an aerobic exercise training intervention to usual care plus exercise advice. The~     primary outcome is the feasibility of the intervention as novel primary therapy in men with~     localised prostate cancer.~   "
49501|NCT02409199|"~     This multicenter, randomized study will evaluate the efficacy and safety of apatinib~     compared to docetaxel treatment in patients with advanced gastric cancer. At the start of~     the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every~     3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks~     according to RECIST 1.1. The primary endpoint is progression free survival (PFS).~   "
49502|NCT02409186|"~     Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2~     decades, well-designed clinical trials have documented the clinical benefits of combination~     of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or~     in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent~     activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for~     the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of~     esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor~     Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR~     expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both~     normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor~     (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models~     have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our~     phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the~     combination of cetuximab and chemoradiotherapy has demonstrated both response and survival~     benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy~     (CCRT) was safe and provided statistically significant objective response (47.8%) and~     disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan~     to study phase III trial.~   "
49836|NCT02404792|"~     The primary objective of this proposal is to compare a moderate or high intensity exercise~     intervention to improve physical function in persons aging with Human Immunodeficiency Virus~     (HIV).~   "
49503|NCT02409173|"~     Obesity is currently one of the most serious public health problems. Its prevalence is~     increasing sharply in recent decades, even in developing countries, leading to global~     epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and~     cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and~     hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical~     condition in more than 60% patients with MS. It is still controversial in the world~     scientific literature whether treatment of OSA with Noninvasive Positive Pressure~     Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV~     effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that~     NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a~     group of severely obese individuals with and without MS undergoing bariatric surgery.~     Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on~     inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of~     life in severe obese patients with and without metabolic syndrome undergone to bariatric~     surgery.~   "
49504|NCT02409160|"~     Obesity is a major public health problem in developed and developing countries, causing a~     range of respiratory and metabolic changes. There is a strong correlation between obesity~     and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and~     improves the quality of life, but clinical treatment it is not effective for a long period.~     In this context, currently bariatric surgery is an option for the real weight loss in the~     long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients~     with obesity. The primary aim of this protocol are to assess the inflammatory profile of~     severe obese patients undergone to bariatric surgery, through systemic and adipose markers~     of inflammation. A secondary objective is study the impact of this surgery on sleep~     variables and quality of life. Investigators hypothesized that weight loss induced by~     bariatric surgery reduces systemic inflammatory profile, improve sleep quality and quality~     of life of subjects with severe obesity. Will participate in this study, patients with~     severe obesity (BMI > 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of~     bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São~     Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to~     participate in the study. Are excluded patients with BMI > 55 kg/m2, clinical instability,~     mental instability or significant and unrealistic expectations of surgery. Patients will be~     assessed before and after bariatric surgery, 90, 180 and 360 days. The evaluation protocol~     will consist of clinical history, vital signs, neck and waist circumference, clinical~     analysis of blood inflammatory markers, lung function tests, maximal ventilatory pressures,~     full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular~     risk, quality of life and personal satisfaction questionnaires.~   "
49505|NCT02409147|"~     This study will explore the feasibility of initiating a uterine transplant program at UNMC.~     Using the procedural templates established by a successful Swedish team, the investigators~     will identify emotionally and socially stable females of reproductive age with intact~     ovaries who are unable to gestate a child due to congenital or acquired uterine factor~     infertility (UFI). Women will be 21 to 35 years of age upon entry into the protocol, with~     normal ovarian reserve and otherwise healthy for pregnancy. After careful screening,~     participants will undergo egg harvest, in-vitro fertilization, and embryo cryopreservation~     using standard methods. Women who successfully complete in vitro fertilization and~     cryopreservation of at least six embryos will be eligible to receive implantation of a~     deceased donor uterus. After a period of observation to ensure normal menstrual cycling and~     graft viability, embryo implantation will be undertaken. Gestations will be carefully~     monitored by our high-risk pregnancy specialists. Medical research interventions include~     uterine harvest from a deceased donor, surgical implantation of the organ utilizing standard~     transplant techniques, careful post-transplant follow-up including immune suppression~     therapy tailored to minimize fetal compromise, and careful management of pregnancy. After~     childbearing is complete (at most two gestations), the donor uterus will be removed. In~     addition, open-ended interviews and written surveys will be conducted to elicit ethical and~     psychosocial concerns arising from the experience of subjects and their families, health~     care providers, and the wider community. The investigators intent is to monitor outcomes~     lifelong for transplant recipients and live-born infants.~   "
49506|NCT02409134|"~     Psychological well-being and cognitive function will be measured in patients enrolled on the~     primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate~     to prevent graft versus host disease following unrelated donor hematopoietic stem cell~     transplantation. Validated questionnaires will be administered to assess patients' level of~     depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality.~     Cognitive testing will include reliable and valid measures of processing speed, attention,~     executive function, episodic memory, and visual learning and memory. The purpose of this~     study is to determine whether these measures are feasible to administer in patients before~     and at early time points after bone marrow transplantation .~   "
49507|NCT02409121|"~     Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow~     transplantation (BMT), is a potentially life-saving therapy for many malignant and~     non-malignant conditions. Despite advances over the past decade, which have led to improved~     outcomes, BMT remains an intense treatment modality often requiring prolonged~     inpatient-based care. While many patients endure the acute complications of the procedure,~     it is common for BMT patients and their caregivers to experience increased risk of financial~     and emotional burden, hospital readmission, and health service utilization. This highlights~     the importance of active involvement of BMT patients in their own health care~     (self-efficacy). For pediatric BMT patients, parents are the primary caregivers. As such,~     parental activation on behalf of the child (patient) plays a critical role in effective~     patient-parent-provider partnerships, which is increasingly recognized as the optimal model~     for health care delivery, particularly for those facing life-altering medical treatments. It~     is essential to develop effective strategies to enhance this partnership. Health information~     technology (IT)-mediated tools offer the potential to overcome constraints in health care~     delivery limited by provider time, complicated health information, and financial pressures.~     Significant gaps in knowledge exist on the use of health IT tools using low-cost and~     well-accepted delivery platforms in routine inpatient care, especially for high-risk or~     critically ill populations. The investigators hypothesize that a tablet-based tool~     displaying personal health information could provide a platform to promote caregiver~     (parent) activation and enhance health communication. In this clinical research study, the~     investigators will conduct a pilot study of an educational health IT system developed on a~     tablet (Apple iPad®) that the investigators refer to as a Personalized Engagement Tool (PET)~     or the BMT Roadmap. The Apple iPad® was selected as the platform for delivery of the~     educational intervention given its ergonomic features. The implementation and evaluation of~     the BMT Roadmap information system in caregivers of children undergoing BMT have been based~     on the generation of user (caregivers and patients) needs that incorporated well-established~     user-centered design processes including qualitative and quantitative research methods~     (published and unpublished data). The assembled investigators represent a strong~     multidisciplinary team with complementary and integrated expertise who are well-poised to~     carry out the proposed research. The Protocol or Study Team includes pediatric BMT~     physicians, Center for Health Communications Research (CHCR) staff, health informaticist,~     biostatistician, and psychologist. This research study is innovative because it addresses a~     gap in the literature on the role of health IT in parent activation on behalf of the child~     in the inpatient setting of a high-risk BMT population. The BMT Roadmap information system~     provides a robust experimental framework for further testing the utility of other care~     components that relate to parent activation or participation and for potential adoption in~     other complex medical conditions. The new knowledge gained herein will thus contribute to~     the evidence base of how health IT improves health care quality and provide the basis of~     further study in a full-scale clinical trial.~   "
49508|NCT02409108|"~     The purpose of this study is to gather information on how safe the hyperthermia treatment~     delivered via the Exatherm-TBH (the device that will heat your blood and deliver it back to~     you), added to the best supportive care is to patients who have advanced persistent or~     recurrent, unresectable Non Small Cell Lung Cancer.~   "
49509|NCT02409095|"~     This is a study planned to determine and compare immunogenicity and reactogenicity of~     DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or~     disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of~     enrollment.~      It will provide information to aid managers, device regulatory control officials,~     immunization programs, and clinicians who make decisions on safe clinical practice~     standards.~   "
49510|NCT02409082|"~     The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma~     to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is~     performed prior to operation. Blood samples and CSF samples are collected at surgery and~     blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days,~     3 months and 1 year. Morbidity is assessed at , 3 months and >1 year. Neuromarkers~     specifically addressing the inflammatory component are to be analyzed and correlated to~     outcome together with AD markers, as above.~   "
49529|NCT02408835|"~     This study investigates the use of a negative pressure wound therapy device (PICO™, Smith &~     Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing~     inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.~   "
49587|NCT02408068|"~     The purpose of the study is to find out whether food has an effect on the way the body deals~     with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate~     release hydrocortisone (fasted). This information will be used to help doctors with dosing~     in clinical practice.~   "
49511|NCT02409069|"~     The goal of this study is to investigate the influence of transcutaneous vagus nerve~     stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy~     volunteers.~      Preclinical and clinical studies indicate that noradrenaline plays a role in the working~     mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive~     vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.~      The release of noradrenaline in the brain will be measured non-invasively by the P300~     component of event-related potentials in the electro-encephalogram (EEG) via an auditory~     oddball paradigm.~      Research to elucidate the working mechanism of non-invasive neurostimulation can help to~     identify subpopulations who will respond well to a treatment and can provide insights that~     could contribute to the optimalisation of the stimulation parameters, with as possible~     consequence a better clinical outcome.~      Some studies indicate that stimulation of the vagus nerve can optimally influence memory,~     possibly via the noradrenergic system. This study will investigate if the effects of~     invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve~     stimulation.~      The influence of transcutaneous vagus nerve stimulation on memory will be measured via a~     neuropsychological memory task that investigates the ability to focus attention. The~     correlation between the performance on the memory task and the signal analysis of the~     auditory oddball task could give an indication about the underlying working mechanism of~     transcutaneous vagus nerve stimulation on memory.~      This will be the first step to investigate whether transcutaneous vagus nerve stimulation~     can be used as innovative intervention for cognitive decline.~   "
49512|NCT02409056|"~     This project is the test of the effectiveness of the Chronic Disease Self-Management Program~     which will be translated to a worksite setting.~   "
49513|NCT02409043|"~     The purpose of this research study is to determine if there are molecules in the blood that~     indicate when a person has had a stroke, and what type of stroke they have had, so that~     appropriate treatment may be begun as soon as possible. This study is also being conducted~     to determine whether these molecules can help to predict long-term health following stroke.~     Some of these potential molecules, also called biomarkers, include Neuronal biomarker~     ubiquitin C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic~     protein (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2),~     which has activity that has been shown to be helpful cardiovascular disease and shown to be~     altered in animal models of acute stroke, where it is also shown to provide neuronal~     protection.~   "
49514|NCT02409030|"~     The purpose of this study is to validate a diagnostic test that combines different blood~     markers to identify and correctly classify patients with Alzheimer's disease (AD) compared~     to individuals with behavioural variant frontotemporal dementia (bvFTD, patient control)~     versus cognitively healthy individuals (healthy control).~   "
49515|NCT02409017|"~     To assess which of two commonly utilized insulin drip protocols has better outcomes when~     used during the labor process.~   "
49516|NCT02409004|"~     This will be a single centre, Phase I, open-label, one cohort, one dose level,~     fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is~     to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting~     conditions.~   "
49517|NCT02408991|"~     The purpose of this study is to measure the concentration of cells and proteins in the~     patient's blood during administration of Nuopogen (Filgrastim), a medication that is FDA~     approved for stem cell mobilization, in combination with a programmed pneumatic compression~     device (PPCD) (Art-Assist Device). The Art-Assist Device is an FDA approved device that~     promotes blood flow in the patient's legs. A patient will be prescribed this device and this~     drug to help improve the poor circulation in his/her leg. The use of Nuopogen along with the~     Art-Assist Device has not been approved by the FDA and is considered experimental.~      This study is not designed to find out how well the Art-Assist Device works, nor how well~     the drug works in mobilizing stem cells. Instead, it is a study of how well cells lining~     blood vessels in calf respond to increases in shear stress, and how well the increase in the~     population of certain cells in the blood stream effect how the new blood vessels will form.~     It is important for clinical reasons, and for the purposes of this study, that the patient~     uses the Art-Assist Device as prescribed on a daily basis as discussed with the patient's~     doctor~   "
49518|NCT02408978|"~     Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the~     study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The~     study will compare the study drug to an already marketed formulation of prescription~     strength naproxen (Naprosyn® the reference product) by looking at the relative impact of~     both products on gastroduodenal (GD) irritation by performing a specialist procedure called~     an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study~     drug will also be assessed.~   "
49519|NCT02408965|"~     Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common,~     occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic~     prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common~     practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to~     decrease excessive bleeding after D&E has the potential both to improve patient safety and~     to reduce costs of provider-initiated interventions. The investigators propose a randomized,~     controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing~     excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24~     weeks.~   "
49520|NCT02408952|"~     This study evaluates the implementation and effectiveness of two modalities of Screening,~     Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other~     drug (AOD) use in a large pediatrics clinic.~   "
49521|NCT02408939|"~     Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal~     insufficiency, and circulatory failure. Such severe pathology may be associated with~     increased susceptibility to infectious complications and increased risk of death due to~     postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In~     this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will~     use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 &~     NCT00729794), in order to determine the effect of stress-dose steroids on the severity of~     postresuscitation infectious complications, and more specifically, on the risk of septic~     shock-associated death.~   "
49523|NCT02408913|"~     Background:~      - Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to~     death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved~     treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (~     MVA-EbolaZ g) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune~     response against Ebola.~      Objectives:~      - To see if the two new vaccines are safe and if they cause any side effects. Also, to study~     immune responses to the vaccines.~      Eligibility:~      - Healthy adults ages 18-50.~      Design:~        -  Participants will get one or two study vaccine injections depending on the study group~          they are assigned to. Each injection will repeat the same schedule:~        -  A needle and syringe will inject the vaccine into an upper arm muscle.~        -  1-2 days later, participants must call the clinic to report how they feel.~        -  For 7 days they will check their temperature with a thermometer given to them. They~          will look at the injection site, and measure any redness or swelling with a ruler. They~          will write down any symptoms they have.~        -  In the first 2 months, participants will have at least 6 clinic visits and 1 phone~          contact. At each visit, participants will be checked for health changes or problems.~          They will tell how they feel and if they have taken any medications. Blood and urine~          samples may be collected.~        -  Participants might need to have extra clinic visits and laboratory tests if they have~          health changes that need to be checked.~   "
49524|NCT02408900|"~     Background:~      - Primary lateral sclerosis (PLS) is a rare disease. It leads to weakness in the muscle of~     the arms, legs, and face. People with PLS develop muscle stiffness called spasticity.~     Researchers want to find a better way to measure this. They want to see if ultrasound, which~     uses sound waves to look at parts of the body, can measure spasticity and stiffness in~     muscles.~      Objective:~      - To see if ultrasound can detect and measure muscle spasticity in people with PLS.~      Eligibility:~        -  People ages 18 75 who have a diagnosis of PLS and are enrolled in protocol 01-N-0145.~        -  Healthy volunteers ages 18 75.~      Design:~        -  Participants with PLS will have 1 study visit. Healthy participants will have upto 5~          visits. Each visit will be about 2 hours.~        -  Participants will have tests of muscle strength. They will be examined. They will push~          their arms and legs against researchers in different positions.~        -  Participants will have tests of muscle stiffness. Their arms and legs will be moved~          while they relax.~        -  Participants will have a muscle ultrasound test. They will lie on a table. Gel will be~          placed on the skin over the muscles of the arms and legs. A probe, like a microphone,~          will be moved over the skin. Researchers will look at several muscles.~        -  Participants should try to stay still during the ultrasound. It may be done several~          times and may be done by different examiners.~   "
49525|NCT02408887|"~     Background:~      - Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard~     to detect. People often have lymph nodes removed anyway, and researchers want to study if~     this is a good idea.~      Objective:~      - To compare the effectiveness of removing lymph nodes in the neck that show no evidence of~     cancer along with the thyroid, or removing only the thyroid.~      Eligibility:~      - Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence~     that the disease has spread in the body.~      Design:~        -  Participants will be screened with medical history, physical exam, blood tests, scans,~          and x-rays.~        -  Participants will:~        -  Answer questions. They may have a tumor biopsy.~        -  Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal~          cords.~        -  Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be~          removed if the cancer has spread.~        -  Group 2: have surgery to remove the thyroid and lymph nodes in the neck.~        -  At all post-surgery visits, participants will answer questions and have blood drawn. In~          addition:~        -  1 day: laryngoscopy.~        -  2 weeks: possible laryngoscopy.~        -  3 months: ultrasound of the thyroid and neck.~        -  Discuss whether to try hormone treatment and/or radioactive iodine.~        -  Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a~          capsule or liquid and lie under a camera.~        -  6 months: ultrasound and maybe laryngoscopy.~        -  1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating~          hormone.~        -  Participants will have annual follow-up visits for 10 years. They will have a physical~          exam, blood drawn, scans, and may complete a questionnaire.~   "
49526|NCT02408874|"~     Background:~      - Nanosilver is tiny silver particles. Many products contain nanosilver, like antimicrobial~     cleaning supplies and antimicrobial fabrics. Some products also contain nanosilver in a~     solution that people inhale. The companies that make these products claim they can help~     boost the immune system.~      Objective:~      - To learn if inhaling nanosilver affects the lung s immune system. In addition, to see if~     nanosilver affects lung function and if it gets absorbed into the bloodstream after it is~     inhaled.~      Eligibility:~      - Healthy, non-smoking adults ages 18 60.~      Design:~        -  Participants will be pre-screened by phone.~        -  Participants will then be screened with a medical history and physical exam. They will~          give blood and urine samples.~        -  Participants will have lung function tests. They will breathe into a spirometer. It has~          a mouthpiece attached to a tube that is connected to a computer.~        -  Participants will have a methacholine challenge test. They will blow into a spirometer.~          Then they will inhale methacholine.~        -  Eligible participants will have 3 study visits over 2 5 weeks. At each visit, they will~          repeat some of the screening tests.~        -  At visit 1, participants will have a bronchoscopy. For this, an intravenous line is~          placed in an arm vein. Electrodes are placed on the chest. A tube is placed through the~          nose and into the airways. The airway is washed. A sample of cells is taken.~        -  At visit 2, participants will get the study treatment. They will inhale a nanosilver~          solution mist. They will have lung function tests before and after treatment.~        -  Participants will collect their urine from the time they get the treatment until they~          return to the clinic the next day.~        -  At visit 3, participants will turn in their urine. They will have another bronchoscopy.~   "
49527|NCT02408861|"~     This phase I trial studies the side effects and best dose of nivolumab when given with~     ipilimumab in treating patients with human immunodeficiency virus (HIV) associated solid~     tumors have spread to other places in the body or cannot be removed by surgery. Monoclonal~     antibodies, such as ipilimumab and nivolumab, may block tumor growth in different ways by~     targeting certain cells. Ipilimumab is an antibody that acts against a molecule called~     cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by~     shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell~     death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving~     ipilimumab with nivolumab may work better in treating patients with HIV associated solid~     tumors.~   "
49528|NCT02408848|"~     There are few studies evaluating the value of 3D echocardiography in children undergoing~     congenital cardiac surgery. The aim of this observational study is to describe common and~     uncommon congenital malformations with the help of 3D echo and compare the findings and the~     measurements with those obtained with conventional 2D echo.~   "
94747|NCT01816958|"~     application of external neuromodulation along with ketamine infusion.~   "
49533|NCT02408783|"~     A large number of mothers are uncertain of the date of their last menstrual period and where~     there is a high incidence of small-for-dates babies, there is a real need for a method of~     estimating gestational age that is both rapid and accurate for early referral and management~     of preterm newborns to reduce their mortality and morbidity. The National Family Health~     Survey 2005-06 reports that the proportion of low birth weight babies (LBW) in India is 22%.~     Of these LBW babies, the proportion of prematurity is not known in the survey as it is~     difficult to measure gestational age of the newborn due to lack of reliable and valid scores~     with ease of use at the primary health centers. Different scores to assess maturity have~     been developed namely New Ballard score, Dubowitz score and Meharban Singh score. It is not~     known whether these scores have regional, geographical, racial or ethnic robustness. It has~     also been found that these scores tend to overestimate newborns > 37 weeks and underestimate~     those >32 and < 37 weeks. The investigators conducted a cross sectional study to validate~     three neonatal gestational age (GA) assessment scores namely New Ballard, Dubowitz and~     Meharban Singh with the reference standard i.e. GA assessed by LMP using Naegeles rule and~     validated by gestational ages also assessed by at least one ultrasound (GA-LMP), in Indian~     newborns delivered at a tertiary hospital. The investigators derived a new Simplified~     Gestational Age Score (SGAS) using the best applicable items from the three validated~     scores and assessed its accuracy with the reference standard (GA-LMP). This score has only 4~     items (posture, skin texture, breast and genital assessment) and community health workers~     can be trained in implementing SGAS due to its simplicity. The investigators propose a study~     in the GN sites to validate this simplified method of assessment of the GA using our SGAS~     protocol.~   "
49534|NCT02408770|"~     The primary objective of this study is to determine the effects of the antiprogestin~     ulipristal acetate (UA) on the epithelial and stromal compartments of the normal breast in~     women at increased risk of breast cancer (BC) and to relate these effects to quantitative~     changes on multiparametric magnetic resonance imaging (MRI). The goal is to define~     predictive imaging biomarkers for subsequent testing in randomised prevention trials of~     antiprogestins.~   "
49535|NCT02408757|"~     As elaborated above only one study reported ultrasonographic changes of the width of the~     lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might~     be suitable. No firm data exists about the change of the width of the third ventricle, the~     diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the~     width of these structures has been shown to depend on intracranial pressure.~     Ultrasonographic measurements of changes of the width of the third ventricle or the diameter~     of the optic nerve would have some advantages compared to the ultrasonographic assessments~     of the lateral ventricles. First, the width of the third ventricle can be measured easier~     and more reliable than the width of the lateral ventricles (better defined insonation plane~     and therefore higher repeatability of measurements) 3. Second, whereas assessments of the~     width of the side and third ventricles with ultrasound depend on the temporal bone windows~     (10 to 15% of patients have insufficient temporal bone windows), the measurement of the~     diameter of the optic nerve does not have this limitation and can therefore be performed in~     almost all patients. Hence, measurement of the diameter of the optic nerve would allow to~     overcome one major limitation of transcranial ultrasound. The latter limitation for~     transcranial ultrasound could also be minimized by the use of an ultrasound contrast agent~     (SonoVue®), but this was also not yet studied. The use of an ultrasound contrast agent would~     in addition allow to study changes of brain perfusion during clamping of EVD/LD.~   "
49536|NCT02408744|"~     The aim of this study was to evaluate the impact in safety and efficacy of a new formulation~     of prolonged-released Pirfenidone in the progression of renal damage in patients with~     Chronic kidney Disease (CKD).~   "
49537|NCT02408731|"~     Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of~     oxygen and nutrients that are necessary for cellular function. The current resuscitative~     agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low~     doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and~     proved to be a highly effective resuscitative agent. The investigators are conducting a~     phase I clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of centhaquin citrate in normal healthy volunteers.~   "
49538|NCT02408718|"~     The purpose of this study is to determine whether a training program in the use of~     ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase~     functional mobility and neural connectivity in people with Multiple Sclerosis.~   "
49539|NCT02408705|"~     Each subject will be allocated to 2 periods of 3 months of once daily dosing with either~     liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive~     insulin treatment. Wash-out period between treatments will be 1 month.~      The trial can be divided into the following periods:~        -  Screening~        -  Treatment period 1~        -  Washout period~        -  Treatment period 2~        -  Follow up Visit~      Mixed Meal Tolerance Test (MMTT) enriched with paracetamol:~      At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol~     will be performed to assess the remaining beta-cell function via obtained maximal plasma~     C-peptide levels as well as the gastric emptying.~      Experimental / Hypoglycaemic clamp :~      At the end of each period (Visit 8, 15) a hypoglycaemic clamp will be performed. After the~     subject completed the MMTT on day 1, the subject will stay in the clinical unit to prepare~     for the hypoglycaemic clamp with an variable insulin infusion intravenously in order to~     obtain a steady state of a plasma glucose (PG) level of 5.5 mmol/L overnight until~     approximately 08:00. At 05:00 hours 10%-[6,6-2H2] glucose solution will be given i.v. as a~     primed (9.6mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last~     blood sampling of the plateau 4.0 mmol/L will be performed.~      At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min~     for each subject and the PG will be kept at a plateau of 5.5 mmol/L by a controlled variable~     intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for~     one hour. Afterwards, PG is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of~     2.5 mmol/L, then to a blood glucose of 4.0 mmol/L and finally back to a level of 5.5 mmol/L~     for safety reasons. Blood sampling for measurement of [6,6-2H2] glucose, glucagon, insulin,~     counterregulatory hormones, lactate, free fatty acids, glycerol, vital signs, hypoglycaemic~     symptoms questionnaire and hypoglycaemic awareness will be performed at each PG plateau.~   "
49540|NCT02408692|"~     The purpose of this research study is to determine how body weight changes the drug level of~     an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This~     emergency contraceptive is available to women without a prescription, but has recently been~     found to not work as well to prevent pregnancies in women of higher body weight. The overall~     goal of this research is to improve the effectiveness of contraception for women, no matter~     their weight.~   "
49541|NCT02408679|"~     The purpose of this clinical study is to evaluate the metrological properties of a~     questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood~     dosage.~   "
49588|NCT02408055|"~     A study to measure the absorption, metabolism and excretion of a single dose of~     radiolabelled TA-8995 (10mg) in healthy male subjects.~   "
49589|NCT02408042|"~     To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab~     in subjects with advanced lymphoma and determine the complete response rate.~   "
49931|NCT02403557|"~     The purpose of this study is to determine whether tailored internet-administrated cognitive~     behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and~     comorbid depressive symptoms in older adults.~   "
49542|NCT02408666|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate~     clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so~     that hospital admission in the EMU can be avoided for some patients and an increasing number~     of patients can be examined.~      In Phase 1 of the project epilepsy patients and their family will be interviewed about their~     personal experiences with the condition, EEG registrations, daily life, ... . In addition~     EEG-technologists and neurologists will be interviewed about their experience with EEG~     registrations and what features their dream EEG-cap would have. The purpose is to gain~     insight in the wishes and expectations of the end users so we can take this into account~     when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.~      Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50~     EEG-technologists or neurologists will be interviewed.~      The results of the interviews will be analysed by the design company pilipili nv.~   "
49543|NCT02408653|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate~     clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so~     that hospital admission in the EMU can be avoided for some patients and an increasing number~     of patients can be examined.~      In Phase 2 of the project will comprise of an EEG-registration with the different types of~     electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes~     will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and~     cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential~     (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations,~     for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP~     measurement with conventionally used wet electrodes (bridge and cup electrodes). Each~     EEG-registration will take between 5 and 10 minutes.~      Minimum 2 - maximum 10 healthy volunteers will be included.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience will also be collected.~   "
49544|NCT02408640|"~     The aim of this randomized controlled trial is to investigate the effects of a Swedish~     Internet-based treatment program for individuals from the general population with a regular~     cannabis use.~      The primary hypothesis to be tested is that the use of the Internet-based treatment program~     will be associated with more cannabis-free days in comparison to only access to information~     about cannabis use and its harmful effects.~      The secondary hypotheses to be tested are:~        1. That the use of the Internet-based treatment program will be associated with a larger~          decline in cannabis consumption (frequency and quantity) among individuals with regular~          cannabis use in comparison to only access to information about Cannabis use and its~          harmful effects.~        2. That the use of the Internet-based treatment program will be associated with a larger~          decline in alcohol consumption, depression and anxiety and increased sense of coherence~          in comparison to only access to information about Cannabis use and its harmful effects.~        3. That the proportion of individuals who seek professional help or talk to their~          relatives or friends about reducing or stopping cannabis use will be greater among~          those who use the Internet-based treatment program than among those who only have~          access to information about cannabis use and its harmful effects.~      Recruitment procedure and baseline measures Study participants will be recruited through an~     advertisement on Cannabishjalpen.se. Interested individuals will answer questions about~     gender, age, country of birth, educational attainment, employment, marital status, living~     situation, and cannabis use.~      The intervention group Individuals randomized to the intervention group will directly after~     randomization answer questions about alcohol use, use of drugs other than alcohol and~     cannabis, depression, anxiety, a sense of context and whether they during the last 12 months~     has received professional help to reduce or quit their cannabis use or during the same~     period have raised this issue with their relatives or friends.~      Further, they will fill out a survey on Internet-based services for individuals who wish to~     reduce or quit their cannabis use. The study participants will then be informed that they,~     within two days, will gain access to an internet based treatment program designed to help~     them quit their cannabis use and that they through the program will have the opportunity to~     communicate with a therapist. Within the next two days, they will gain access to the~     internet-based treatment program, they will have access to it for two months and they will~     be contacted again after three months to answer questions about their cannabis and alcohol~     use, as well as about other previously mentioned issues.~      The control group Individuals randomized to the control group will undergo exactly the same~     procedure as the intervention group. The difference is that the control group will be~     informed that they in about three months will gain access to an internet based treatment~     program designed to help them quit their cannabis use (i.e. when the data collection for~     follow-up is completed).~      Otherwise, participants in both groups will have the opportunity to use factual information~     that is available to everyone on Cannabishjalpen.se.~      Follow-up procedure Study participants who were randomized to the intervention group will~     have access to intervention in two months. Three months after recruitment to the study,~     study participants from both groups will get an automated email invitation to participate in~     the three-month follow-up. The email will include a personalized link that when clicked on~     will redirect the participant to follow-up page where they will be asked to once again~     answer questions about their cannabis and alcohol use, depression and anxiety, seeking~     professional help for cannabis use as well as the help of family or friends and questions~     about whether they have used any other internet or telephone services to reduce or quit~     their cannabis use. The entire follow-up procedure will be completed via the internet.~   "
49545|NCT02408627|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate~     clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so~     that hospital admission in the EMU can be avoided for some patients and an increasing number~     of patients can be examined.~      Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.~      Phase 3a of the project will comprise of an EEG-registration with the different types of~     electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on~     EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the~     EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each~     EEG-recording will take approximately 10 minutes.~      Minimum 2 - maximum 10 epilepsy patients will be included.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience will also be collected.~   "
49546|NCT02408614|"~     The study objectives are the following: 1) To examine the acute vascular responses to~     continuous low- and moderate-intensity exercise and interval training; and 2) To examine the~     influence of age and gender on these responses.~   "
49547|NCT02408601|"~     Background and study aims:~      The investigators are carrying out a clinical trial of two different sealant materials to~     compare the retentivity and decay inhibiting properties of the above said materials. it is a~     split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite~     placed molars of 180 healthy school children in the age group between 7 - 10 yrs of age.~      who can participate? school children in the age group between 7 - 10 yrs of age with non~     decayed contra lateral permanent 1st molars at a school in the southern part of India.~      what does the study involve? over a period of 18 months, the retentivity and the decay~     preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS)~     will be clinically assessed by us.~      possible benefits/ risks of participating in the trial the participants will be not be~     exposed to any kind of risks as it is a non invasive procedure the possible benefits may be~     preventing decay to the permanent molar in the long run~      study start date/duration of the study? MARCH 2015 is the month wherein the sealant~     applications have started and expected to last till the Sept of 2016~      funding? self funded study~   "
49548|NCT02408588|"~     Using a pulse oximeter, the investigators have developed an algorithm that assesses central~     volume status. Pregnant women present some unique opportunities for us to investigate the~     algorithm under different circumstances. The investigators want to specifically investigate~     an algorithm with women who undergo regional anesthesia such as epidurals, with women who~     undergo fetal surgery, and with women in labor and giving birth (and the recovery time~     following delivery). This will help the investigators understand the central volume status~     changes that women experience in these unique circumstances. The Investigators also want to~     put the pulse oximeter on the fetal hand when possible during certain maternal fetal~     interventions. The Investigators would like to examine the algorithm with data from the~     fetuses.~   "
49549|NCT02408575|"~     Pilot study on safety, tolerability and clinical performance/randomized double-blind~     active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus~     Center of Regensburg and groupwise randomized. Control groups are being treated with hearing~     aids without notch-filter. Patients and raters are blinded, only the coworker, who is~     programming the hearing aids, is informed about the group assigned.~      A Hearing aid with notched amplification filters frequencies in a specific manner, depending~     on the individual tinnitus frequency. Through this special filtering the neuronal functional~     changes of the auditory cortex are supposed to be affected therapeutically.~   "
49550|NCT02408562|"~     This is a phase I, randomised, placebo-controlled study to assess the safety and~     tolerability of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to~     patients with PD of moderate severity with persisting on-off symptoms in spite of other PD~     medications.~   "
49551|NCT02408549|"~     Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive~     therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4~     years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects~     from the LCM SP0982 (NCT02408523) study.~   "
49552|NCT02408536|"~     The purpose of this study is to retrospectively evaluate treatments and outcomes of patients~     with low grade serous ovarian carcinomas in Italy.~   "
49553|NCT02408523|"~     Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on~     Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age with~     idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum~     duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the~     open-label extension study after completion.~   "
49554|NCT02408510|"~     The goal of this proof of concept/feasibility study is to use rigorous methodology to~     explore links between daytime energy status and nocturnal fat metabolism in healthy adults.~   "
49555|NCT02408497|"~     A single arm phase I study of prostate motion for prostate cancer to primarily compare~     prostate motion between different treatment duration for IMRT and VMAT.~   "
49556|NCT02408484|"~     This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the~     on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients~     less than 12 years of age.The planned study duration is up to 5 years. The study will be~     considered completed when a minimum of 6 subjects (i.e., at least 3 subjects aged between 0~     and <6 years and 3 subjects aged between 6 and <12 years) have at least one documented~     bleeding episode and when in total a minimum of 2 surgical procedures have been performed.~      All patients will undergo a pharmacokinetic (PK) study after screening. This will have a~     duration of 14 days, after which a patient can be treated for a bleeding episode or planned~     surgical procedure when they occur.~   "
49557|NCT02408471|"~     This study is a non-randomized, consecutive enrollment, one-year post-approval study of~     patients who are treated with the Ascension® MCP.~   "
49558|NCT02408458|"~     This study is being conducted to gather long-term data of the performance of the Miromatrix~     Biological Mesh.~   "
49559|NCT02408445|"~     This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about~     body composition (muscle and fat) and male hormones and look at the effect of testosterone~     shots on body composition. We know that older boys and men with Klinefelter syndrome often~     have more fat compared to muscle than adults without Klinefelter syndrome, but we do not~     know if this difference is present at birth or develops over time. We will learn if body~     composition and motor skills are improved with testosterone treatment in infants with~     Klinefelter syndrome.~   "
49560|NCT02408432|"~     The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)~     to standard of care drugs can help control heart failure that may have been caused by~     anthracyclines. The safety of the MSCs will also be studied.~      MSCs are a type of stem cell that can be removed from bone marrow and grown into many~     different cell types that can be used to treat cancer and other diseases, such as heart~     failure. The MSCs used in this study were collected from healthy donors and are stored and~     grown in a laboratory at MD Anderson.~   "
49561|NCT02408419|"~     About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a~     femoral nerve block. One of the possible causes of this failure to provide analgesia from a~     single nerve block could be the that other nerves occasionally are involved in transmitting~     the pain signal. One of the nerves that is believed to give off branches to the hip is the~     obturator nerve.~      With ultrasound it is possible to make a selective proximal nerve block of the obturator~     nerve.~      The aim of this trail is to give patients with hip fracture and only insufficient effect of~     a femoral nerve block a supplementary obturator nerve block in a randomized manner with~     either local anesthetics or placebo in order to access the preoperative analgesic effect.~   "
49562|NCT02408406|"~     This partially randomized pilot clinical trial develops and studies a software program,~     called PatientCareAnywhere, to see whether it can help patients communicate with their~     doctors and other healthcare providers, and educate themselves about their cancer and~     treatment options. A program that can help patients learn about their cancer and treatment~     options, and allows the patient's healthcare providers to receive their questionnaire~     results, may help patients identify and get help to treat their symptoms.~   "
49563|NCT02408393|"~     Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence~     of chronic pain 3 months after breast cancer surgery.~   "
49564|NCT02408380|"~     This study investigates whether there is a link between disease activity/progression in~     patients receiving Gilenya and expression of a putative biomarker signature in patients with~     multiple sclerosis.~   "
49565|NCT02408367|"~     Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to~     the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis~     (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve~     cardiovascular and cognitive functions in pwMS have become important aspects of standardized~     rehabilitation programs. Recent findings show that the achieved adaptations through exercise~     are associated with the intensity dependent lactate increases during exercise. This~     dose-response relationship between the mode and the exercise intensity implicates the~     relevance of the exercise protocol as higher exercise intensities seem to facilitate greater~     benefits, also in pwMS.~      This pilot study evaluates the influences of acute bout of moderate physical exercise~     (cycling) and relaxation on cognitive functions at three time points.~      Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via~     the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised~     (BVMT-R) T1-3 of the BICAMS battery.~      Results should into a randomised controlled Trial that investigates the specific influences~     of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin~     Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central~     neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive~     functions.~   "
49566|NCT02408354|"~     The purpose of this project is to study the efficacy of triheptanoin oil in patients with~     Alternating Hemiplegia of Childhood (AHC) due to ATP1A3 gene mutation.~   "
49567|NCT02408341|"~     Background: Propofol effects dose-dependent myocardial depression, but there is little~     clinical data available regarding the direct impact of propofol induction on myocardial~     function.~      Objectives: The purpose of this study was to examine the impact of propofol-based anesthesia~     induction on cardiac function in low-risk patients.~   "
49568|NCT02408328|"~     Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it~     is relatively more common in extremely premature infants, it also occurs frequently in late~     preterm and even full term infants. Since the majority of all births include late preterm~     infants and full term infants, the absolute number of late preterm and full term infants~     with apnea remains significant. Evidence-based guidelines for the management of apnea in~     such infants do not exist. Current management falls into two distinct but very different~     categories. This study will compare these two distinct management strategies.~      Our study will be a prospective, randomized pilot trial to provide data regarding (a)~     feasibility for recruitment and study protocols and (b) provide preliminary data regarding~     efficacy of both treatment arms.~      Our primary objective will be to test the hypothesis that early discharge and outpatient~     monitoring of late preterm and term infants with apnea of prematurity results in decreased~     length of hospital stay, is safe, and results in improved patient satisfaction, as assessed~     by the PedsQL questionnaire and Impact on Family Scale.~      Our study population will include infants who meet the following criteria: (1) Born at~     greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea,~     bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all~     other discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that~     apnea/bradycardia/desaturation remains the final discharge issue for at least 7 days.~      Infants enrolled in this research study will be randomized to in hospital observation versus~     early discharge home with caffeine and a home monitor. Neither strategy is experimental as~     both are currently utilized by neonatologists locally and nationally. A direct comparison of~     the two treatments, however, has never been undertaken in a study. If an infant is assigned~     to the in hospital group, they will remain in the hospital until an apnea free period of at~     least 5 consecutive days has been established. Outpatient follow up will occur per unit~     standard and typically includes a nursing visit and a doctor visit within 2-3 days of~     discharge. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1~     month after hospital discharge, and at 6 months of age. Each questionnaire will ask about~     topics such as satisfaction with hospital stay, quality of life, and numbers of acute care~     visits and/or rehospitalizations. Alternatively, if an infant is assigned to the early~     discharge group, caffeine will be given to the infant and if after a 3 day period no further~     apnea is noted the infant will be discharged home with continued daily caffeine therapy by~     mouth as well as a home monitor. Caffeine is a very commonly used drug in neonates and has~     an excellent safety profile. Side effects are minimal and may infrequently consist of~     gastroesophageal reflux. All caregivers will receive training on the use of a home monitor.~     Initial outpatient follow up will occur per unit standard and typically includes a nursing~     visit and a doctor visit within 2-3 days of discharge. Additionally, caregivers will be~     contacted via telephone within 2 days to answer any questions or address any concerns~     pertaining to apneic events, home monitor use, or caffeine therapy. Follow up in the~     pulmonary clinic will be arranged at 42-43 weeks gestational age at which time caregivers~     will be taught to determine the baseline frequency of monitor alarms on caffeine. At 43~     weeks corrected gestational age, caregivers will be instructed to discontinue caffeine~     therapy and advised to contact the pulmonary clinic should alarm frequency increase. An~     outpatient recorded oximetry study will be arranged at least 1 week after discontinuation of~     caffeine therapy. Home pulse oximetry monitoring will be discontinued if no significant~     events are recorded. Caregivers will be asked to complete 3 brief questionnaires at~     enrollment, at 1 month after discontinuation of the home monitor, and at 6 months of age.~     Each questionnaire will ask about topics such as satisfaction with hospital stay, quality of~     life, and numbers monitor alarms, acute care visits and/or rehospitalizations.~   "
49569|NCT02408315|"~     The primary objective of this study is to compare the efficacy and safety of vaginal and~     buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0~     completed weeks gestation. Thus, the investigators have both efficacy and a safety primary~     outcomes.~      The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with~     these two routes of administration in a sub-cohort of this trial. The long term objective of~     this line of research is to inform providers' clinical decision making for the large number~     of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation,~     clinical outcomes data for these two routes of administration, clinicians will be informed~     for evidence-based decisions about the preferred route of administration of misoprostol.~   "
49570|NCT02408302|"~     Currently Midazolam sedation is the standard of care for minor invasive procedures in~     pediatric patients; its use is restricted to two routes of administration for this purpose~     oral and intranasal.~      A third route of administration (buccal) is tested and approved for seizure management. In~     the investigators' study the researchers investigate the buccal route of administration~     versus oral or intranasal administration for sedation. The investigators' hypothesis is that~     buccal route of administration is more convenient than intranasal and better absorbed than~     oral.~   "
49571|NCT02408289|"~     The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite~     in humans. In addition the study is designed to test epicatechin, a compound found in cocoa~     and procyanidins, a class of compounds found in cocoa, for their ability to decrease~     appetite in humans.~   "
49572|NCT02408276|"~     Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the~     development of early cartilage and labral damage in the non-dysplastic hip. Anatomic~     abnormalities of the proximal femur and/or acetabulum result in repetitive injury during~     dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction~     against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding~     capsular structures predispose the patient to developing hip pain and early osteoarthritic~     changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of~     presentation from pain to instability that may or may not be related to activity. To date no~     studies have identified specific prognostic indicators associated with successful surgical~     treatment of FAI, leaving surgeons without adequate criteria to determine which patients are~     best suited for arthroscopy. The investigators propose to address this critical knowledge~     gap by identifying the patient characteristics and morphological features of the hip that~     are associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or~     non-operative management for treatment of suspected FAI in order to establish a treatment~     algorithm for FAI patients.~   "
49573|NCT02408263|"~     Pain has been defined as a subjective experience. Various pain assessment tools, (such as~     NRS) have been developed and validated to objectively monitor and treat pain. There are~     certain patient populations, in whom, the current pain assessment tools cannot be used~     effectively due to communication problems such as cognitively impaired patients. In the US,~     the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it~     mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that~     would objectively measure pain, there is also risk of under treatment and overtreatment of~     pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain~     levels objectively, will help to achieve above goals. The investigators are using Skin~     Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.~   "
49574|NCT02408250|"~     Practice guidelines recommend early physical therapy in intensive care unit. Feasibility,~     safety and efficacy are confirmed by growing evidence based data. However, the scientific~     literature emphasizes the heterogeneity of targeted populations, lack of precisions~     concerning eligibility criteria, program modalities, timing initiation, progressions and~     stopping criteria. However, all these results remain to be precised and confirmed. So, the~     investigators hypothesize that an early exercise program in intensive care unit formalized~     from a decisional algorithm is well tolerated in clinical practice.~   "
49590|NCT02408029|"~     This study is being performed to obtain data about the CORA System when used in a trauma~     clinical setting. The CORA analyzer is a new device that is currently being tested in trauma~     clinical applications and is not yet cleared for this purpose by the Food and Drug~     Administration (FDA) for sale in the United States.~   "
50311|NCT02398578|"~     Phase I/II study to assess the safety and performance of the Amphora OAB system for~     treatment of urgency and frequency with or without urge incontinence caused by an overactive~     bladder.~   "
49575|NCT02408237|"~     Neuromodulation is characterized as a technique whose principle neurostimulation to produce~     inhibition or cortical arousal. The tDCS (transcranial direct current stimulation) is a~     noninvasive brain stimulation method used to modulate cortical excitability using low~     intensity direct current (1-2mA) directed to the scalp via cathodes and anodes electrodes;~     the current reaches the cortex, producing hyperpolarization or depolarization of the axonal~     membrane potential. Evidence has shown that this method is presented as a technique that can~     alter cortical and subcortical neural networks. This technique has been used to treat~     psychiatric disorders such as depression, acute mania, bipolar affective disorder panic,~     hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation~     after-stroke and pain syndromes such as neuropathic pain, migraine, pancreatitis chronic~     pain and fibromyalgia. It is low-cost technique, with virtually no side effects and carries~     the therapeutic effect by neuromodulatory pathways by distinct pathways activated by the~     drugs. In this scenario falls within the importance of developing devices for home use,~     inexpensive, and easy to use so as to maintain the benefits observed in previous studies.~     The tDCS is presented as a non-pharmacological option that may be offered in this context in~     society. It is noteworthy that, if the benefit is demonstrated, the impact will be of great~     importance to patients and to society, since these are focal techniques and low cost.~     Because they have no focal adverse effects of conventional drug treatments. Additionally,~     can be constituted as technical additive to pharmacotherapy in so much pain as in the~     treatment of other neuropsychiatric disorders. Therefore, further studies should be~     encouraged to increase knowledge of their effects and mechanisms involved. If the~     effectiveness of this method for home use is confirmed, the therapeutic impact will~     undoubtedly be of great importance. However, to make this project come true, the~     investigators depend on support for the development and validation of tDCS device for home~     use, so allowing the qualified knowledge can be applied to the clinical setting, as well as~     advance the development of this area of neuroscience in Brazil. Therefore, the aim of this~     study is to develop tDCS device for home use.~   "
49576|NCT02408224|"~     The TREASURE observational study is designed to address the need to understand the usage~     pattern of Ticagrelor in real life scenario in large number of ACS (Acute Coronary Syndrome)~     patients in India. The aim of this national study is to understand the usage pattern~     (including the duration of treatment) of Ticagrelor in various ACS patient population~     undergoing PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Graft) or~     medical management in a real-life setting in India.~   "
49577|NCT02408198|"~     This study aims to evaluate a novel group psychological intervention targeting anxiety~     triggered by urban environments for people with paranoia.~   "
49578|NCT02408185|"~     Phase II clinical trial, open-labelled, prospective and single-center study directed to~     obtain blood samples in experimental detailed conditions in order to compare and optimize~     the dose of colistin in critically ill patients suffering from infections on which the~     indication of colistin would be accepted according to normal local protocols for severe~     infections treatment.~   "
49579|NCT02408172|"~     Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3%~     to 7% in middle aged individuals and increases with age. OSA has been identified as the most~     common secondary cause associated with resistant hypertension. There is evidence that~     compared with older patients, the risk of hypertension in OSA patients may be particularly~     pronounced in younger adult ones (less than 50 years).~      Traditionally, cardiovascular risk stratification in hypertensive patients was based on the~     average blood pressure (BP) measured in the clinic. Accumulated data has shown that~     target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP~     variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated~     that BPV has considerable prognostic value for all-cause mortality and cardiovascular~     outcomes, independent of average BP. In addition, it has been found that hypoxia condition~     in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP.~     However, the selections of antihypertensive drugs remain yet not very clearly for~     hypertensive patients combined with OSA.~   "
49580|NCT02408159|"~     This study will evaluate the ability of the vaccine to produce antibodies against herpes~     zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients~     with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after~     vaccination.~      Varicella Zoster Vaccine will be administered 4 to 6 weeks prior to receipt of biological~     therapy and will be compared against placebo.~      This double-blind study will enroll approximately 50 adult patients with moderate-to-severe~     plaque psoriasis in approximately 3 centers in Canada. Study products will be assigned~     randomly at a 4:1 ratio.~      For each patient who is included, the study may last up to 22 weeks, including the screening~     and the follow-up period. During the study, subjects will come to the dermatology clinic up~     to 4 occasions: for a screening visit, Baseline visit, Day 42 as well as 84 days after they~     started taking the biological treatment for a last visit. If patients develop a~     varicella-like or shingles-like rash at any time after they received the vaccine, they will~     be requested to come back to the clinic within 72 hours of rash onset (preferably within 24~     hours) for examination. Subjects will be asked to provide a lesion swab/vesicular fluid in~     this case.~   "
49581|NCT02408146|"~     The investigators hypothesized that using new intravenous infusion pump of~     patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly~     improve postoperative pain control compare to conventional intravenous infusion pump of~     patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16~     mg/8 mL + normal saline). This prospective randomized controlled trial was designed to~     evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia~     (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic~     liver resection.~   "
49582|NCT02408133|"~     The purpose of this study is to evaluate the effectiveness of home exercise on quality of~     life and physical fitness of elderly women with breast cancer patients undergoing cancer~     treatment.~   "
49583|NCT02408120|"~     The purpose of this study is to test whether using extra doses of aspart insulin to correct~     blood sugars before meals improves the care of patients with type 2 diabetes in the hospital~     who are already receiving the standard of care treatment with glargine and aspart insulin~     injections to control blood sugar levels. Studies done in the past indicate that blood sugar~     levels are controlled on the standard treatment of insulin and that most patients do not~     need the small extra dose of insulin at bedtime. The investigators want to test if there is~     any benefit to giving patients extra doses of insulin during the day to correct the high~     blood sugars.~   "
49584|NCT02408107|"~     The aim of this current study was to investigate the effects of a pragmatic home-based~     physical activity programme on primarily physical activity levels and secondarily weight~     maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid~     concentrations in post-adjuvant therapy breast cancer survivors.~   "
49585|NCT02408094|"~     The purpose of this study is to explore the protein markers and to applicate those protein~     markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.~   "
49591|NCT02408016|"~     This phase I/II trial studies the side effects and best dose of genetically modified T cells~     in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma.~     Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells,~     have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune~     cell from patients, called T cells, and modifies their genes in the laboratory so that they~     are programmed to find cells with WT1 and kill them. The T cells are then given back to the~     patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack~     cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may~     help the body build an immune response to kill tumor cells.~   "
49592|NCT02408003|"~     The investigators want to compare the effects of two drugs, levosimendan and milrinone, on~     cardiac muscle, both in terms of contractility and relaxation. Half of the participants will~     be randomized to each drug.~   "
49593|NCT02407990|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-A317 in patients with advanced tumors.~   "
49594|NCT02407977|"~     This is an observational study. This protocol will determine the feasibility of using a~     novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than~     1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during external~     beam delivery of radiation therapy treatments.This new protocol is similiar in design to~     Pro00050297 with the significant difference being the monitoring will be performed during~     external baem radiotherapy.~   "
49595|NCT02407964|"~     This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic~     study without any clinical treatment. Its primary objective is to understand 1) incidence of~     drug-induced liver injury, including incidences among all the hospitalized patient, among~     patients in department of hepatic diseases, digestive diseases, oncology, hematology etc.,~     individually; 2) epidemiologic characteristics of drug-induced liver injury, including~     suspected medications, clinical types, histological characteristics, severity and outcomes.~   "
49596|NCT02407951|"~     Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied~     and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral~     Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not~     been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention~     compared with Psycho-Educational-Supportive group in terms of tic severity.~   "
49597|NCT02407938|"~     Normal values for measurements of high resolution manometry in a protocol which includes~     isolated liquid swallows in upright and recumbent position, free drinking of water, a solid~     test meal and a postprandial observational period will be determined.~   "
49598|NCT02407925|"~     In this study, Dutch gastroenterologists who are certified for performing colonoscopies on~     FIT-positive patients in the Dutch population screening program are trained in optical~     diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads~     to accreditation and endoscopists will be observed in their optical diagnosis for 1 year.~     During this year, half of the endoscopists will be randomized towards 3-monthly feedback and~     the other half will receive feedback on their results after 1 year. The endoscopic~     prediction of endoscopists on polyp histology will be compared to histopathological outcome.~   "
49599|NCT02407912|"~     To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for~     malignant pleural effusion in patients with non-small-cell lung cancer.~   "
49600|NCT02407899|"~     The main purpose of this study is to evaluate whether saxagliptin (and vitamin D3) with~     insulin therapy can better protect islet β cell function than insulin alone.~   "
49601|NCT02407886|"~     Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in~     nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans,~     retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to~     occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in~     adults is considerable rare. It is, however, well established that retrograde transsynaptic~     degeneration affects other neural systems in humans even when the injury occurs during~     adulthood. Some histopathological evidence points to the possibility of transsynaptic~     degeneration of the retinogeniculate pathway in humans even when the lesion occurs in~     adults, but the clinical significance is unknown.'~      Purpose:~      To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due~     to intracerebral processes. To correlate GCL with the localization and type of intracerebral~     lesion.~      To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2~     parameters is more sensitive to show retinal layer abnormalities.~      To correlate GCL with visual field defects and electrophysiological parameters.~   "
49602|NCT02407873|"~     The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75~     years or more and undergoing elective cardiac surgery. In those patients the investigators~     will also record the ITU length of stay, the hospital length of stay, the incidence of~     complications, the ability to be discharged home and to live independently at postoperative~     day 30.~      The ability of the Edmonton score to predict complication, prolonged hospital and ITU length~     of stay as well as loss of autonomy at discharge and day 30 will be assessed.~   "
49614|NCT02407717|"~     Patients with cancer hospitalized for an acute medical illness have an increased risk of~     venous thromboembolic events. Although international guidelines suggest the use of~     thromboprophylaxis in these patients, the recommendations are based on studies which~     included a percentage of patients with cancer without primarily focusing on this high risk~     group.~      Since patients with cancer present an increased risk of bleeding complications it is~     critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies~     suggest a limited use of thromboprophylaxis in these patients.~      The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in~     medical cancer patients hospitalized for an acute medical disease.~      Design: observational, prospective study Primary end-point: incidence of major and~     clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency~     of use, doses and contraindications for pharmacological thromboprophylaxis; venous~     thromboembolic events up to three months after discharge~   "
50312|NCT02398565|"~     We will examine the outcome of ventral hernia repair with subsequent pregnancy~   "
49603|NCT02407860|"~     Breastfeeding is the physiological and recommended way of feeding newborns as indicated by~     the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in~     Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to~     Statistics Canada, the first month of life is the most at risk time to wean because of~     technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite~     a supportive network of health care professionals including lactation consultant, many~     babies are weaned. Lactation consultant are often feeling helpless when facing these~     mechanical difficulties.~      The purpose of this study is to determine the efficiency of an osteopathic treatment for~     newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is~     that an osteopathic treatment integrating in the usual care is more efficient than usual car~     alone to help healing mechanical breastfeeding issues.~      The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each~     group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The~     control group will receive usual care with a lactation consultant and the intervention group~     will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial:~     the osteopath finds out, prior to evaluating the patient, what intervention should be~     delivered to the baby (assessment alone or standardized osteopathic treatment for infant).~      The results will ultimately lead to improvements in the existing knowledge on the fields of~     osteopathy and lactation support, allowing implementation of osteopathic care in the~     perinatal network.~   "
49604|NCT02407847|"~     The aim of this study is to explore the effects of substitution in out-of-hours primary~     care. In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse~     Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms~     of feasibility and cost-efficiency.~   "
49605|NCT02407834|"~     This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in~     different concentrations for denture cleanliness, regarding biofilm removal capacity,~     remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial~     action against specific microorganism. Sixty-four denture wearers with absence (n=40) or~     presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a~     specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day,~     in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3;~     Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a~     randomized, double blind and cross form with washout periods. To quantify biofilm with~     software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at~     the end of each period. The Candidiasis remission was assessed by scores before and after~     the use of solutions. Patient satisfaction was assessed by questionnaire. Antimicrobial~     activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans,~     Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of~     each maxillary complete denture was brushed with saline solution, and the biofilm suspension~     obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes~     containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting~     S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation,~     colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as~     a split-plot with two variation factors: inflammation and solutions. The candidiasis~     remission was analyzed after adjustment using multinomial logistic regression. Logistic~     regression analysis and compound symmetry was adopted for patient satisfaction. The~     antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were~     processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α =~     0.05).~   "
49606|NCT02407821|"~     In this study the investigators hypothesize that antidepressant therapy may improve the~     overall welling of patients with acute or chronic kidney disease when given around the time~     of starting chronic dialysis therapy. This study is a pilot, randomized controlled trial~     that aims to examine whether prescribing oral escitalopram to all incident dialysis patients~     is safe and feasible.~   "
49607|NCT02407808|"~     The overarching goal of this study is to characterize the effects of cannabinoids on working~     and episodic memory.~   "
49608|NCT02407795|"~     A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with~     stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal~     metastases.~   "
49609|NCT02407782|"~     Scabies remains a frequent condition that affects adults and children. The aim of this study~     is to compare the efficacy and safety of two drug treatments against scabies in children and~     their close contacts. One group will apply topical permethrin 5% and the other group will~     receive oral ivermectin.~      Both groups will be treated twice, once at inclusion and the second time 10 days later. Both~     treatment regimens have been used widely and are safe to use.~   "
49610|NCT02407769|"~     Assess the impact in body composition and handgrip strength of the nocturne supplementation~     by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)~   "
49611|NCT02407756|"~     The primary objective of the study is to characterize the safety and pharmacokinetics (PK)~     of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for~     adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).~      The secondary objective of the study is to explore the immunogenicity and efficacy of~     dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years~     of age) or severe AD (for children ≥6 to <12 years of age).~   "
49612|NCT02407743|"~     The purpose of this research study is to determine what causes pain after surgery to~     increase or decrease over time.~   "
49613|NCT02407730|"~     Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage~     and pregnancy complications. Thrombophilia could favor the development of thrombosis of the~     maternal vasculature and obstacle placentation. Some studies have suggested a role of~     thrombophilia in the failure of assisted reproductive techniques although this association~     has been recently questioned. The scope of this study is to evaluate the effect of~     thrombophilia on the implantation rate and live birth rate in women undergoing ART.~      Design: prospective, observational study Primary end-point: live birth rate. Secondary~     end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks~     post-partum~   "
49627|NCT02407548|"~     In previous study the investigators found that CoQ10 can improve cholesterol efflux from~     macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In~     addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria~     electron transport chain. So the investigators hypothesize that CoQ10 may have some health~     promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular~     diseases. On this purpose, the investigators are going to recruit 180 dyslipidemia patients~     to supply CoQ10+vitamin E or vitamin E alone or CoQ10 alone in different doses for 24 weeks~     to explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.~   "
59788|NCT02274610|"~     Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC~     and Cmax~   "
49615|NCT02407704|"~     This pilot study aims to test a model that predicts that enhanced neurotransmitter~     gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous~     system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art~     magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and~     inflammatory biomarkers will be acquired through the coordination of efforts from several~     established research programs at Western Psychiatric Institute and Clinic. This pilot study~     will be used as a platform for testing a causal/mediating role of GABA interneurons in~     reward processing and affect regulation in humans. This pilot study is not powered for~     testing a full causal model, but rather is intended to test overall feasibility of the~     intervention and acquisition of measures (see specific aim 1 below). This is a necessary~     prerequisite for designing a larger more definitive study of the model, which will be a~     component of a future grant application. Additionally, the data from this study will be used~     to test the clinical efficacy of exercise as an adjunctive treatment for late life~     depression (LLD; Specific Aim 2), as well as imaging, cognitive, and sleep aims (Specific~     Aims 3 and 4).~   "
49616|NCT02407691|"~     With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned~     from a terminal illness to a long-term condition. It is likely to be accompanied by higher~     levels of disability and other chronic non-communicable diseases, resulting from the HIV~     itself, as well as adverse effects of medication. This requires an expansion of the purview~     of HIV care beyond direct HIV clinical care to also include a more comprehensive and~     integrated package of treatment and care for physical and mental conditions and their~     consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public~     sector primary care clinics in the North West Province of SA. It will assess mental health~     and HIV outcomes for depressed adults receiving ART by measuring the real-world~     effectiveness of a facility-based stepped care intervention combining depression case~     detection by non-physician clinicians with group counselling intervention delivered by~     lay-health workers.~   "
49617|NCT02407678|"~     The assessment of the efficacy (with respect to preservation of visual function and retinal~     structure) and safety of a single subretinal injection of AAV2.REP1 in participants with a~     confirmed diagnosis of choroideremia, as evaluated by various functional and anatomical~     outcomes measured over a number of time points up to 24 months post-treatment.~   "
49618|NCT02407665|"~     This exploratory study proposal is the first pilot brain imaging study to determine if Tai~     Chi can modulate brain resting state functional connectivity (rsFC) and brain morphometry~     among fibromyalgia (FM) patients and healthy controls.~   "
49619|NCT02407652|"~     The purpose of this study is to explore the effectiveness of an internet-delivered cognitive~     control training as a preventive intervention for remitted depressed patients.~   "
49620|NCT02407639|"~     Studies in adults have shown that post-procedural abdominal pain is reduced with the use of~     CO2 instead of air for insufflation during colonoscopy. The aim of our study is to compare~     post-procedural abdominal pain and girth in children undergoing colonoscopy using CO2 or air~     for insufflation.~   "
49621|NCT02407626|"~     This study evaluates the myocardial protection against perioperative ischemia comparing two~     standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half~     of the patients will receive volatile anesthesia while the other half will receive total~     intravenous anesthesia. Primary and secondary outcome parameters will be assessed after~     induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.~   "
49622|NCT02407613|"~     This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with~     early-stage breast cancer with a maximum diameter of 3 cm undergo MR-HIFU ablation, followed~     by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is~     to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective~     is safety assessment.~   "
49623|NCT02407600|"~     This study evaluates the addition of fosaprepitant to currently available antiemtic~     treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small~     cell lung cancer patients. Half of the patients will receive fosaprepitant in their first~     chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the~     patients will begin their first chemotherapy cycle.~   "
49624|NCT02407587|"~     Investigators hope to study patients with 1 cochlear implant and who have had hearing~     preservation surgery and compare the changes in the brain of these patients with normal~     hearing patients by doing a scan of the brain when listening to speech. The information~     investigators collect may help investigators to understand how the brain learns to hear with~     a cochlear implant and whether it uses the same areas in the brain to listen as in normal~     hearing patients as well as predict which patients will do well with a cochlear implant as a~     very specialised operation is needed to insert the cochlear implant in to the ear and is~     done by very few surgeons in the country. After the operation, patients need several months~     of teaching to help them learn how to hear through the implant. Having a cochlear implant~     requires a lot of cooperation and time from the patient and if investigators could~     understand how the brain learns to hear with a cochlear implant and predict which patients~     do well and why then we may be able to avoid unnecessary procedures.~   "
49625|NCT02407574|"~     The aim of the study is to determine whether increasing the heart rate by epicardial atrial~     pacing after surgery improves the contractile force of the myocardium. After complete~     weaning from CPB, several pressure-loops of the LV will be recorded at different levels of~     preload using transoesophageal echo, invasive blood pressure monitoring. The preload will be~     manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.~   "
49626|NCT02407561|"~     Patients with locally advanced rectal and esophageal carcinomas typically undergo~     neoadjuvant chemoradiation therapy prior to surgical resection. While response rates to this~     treatment differ among these three cancers, generally 20-25% of patients exhibit minimal or~     no response to preoperative chemoradiation therapy while 20-30% exhibit a complete~     pathologic response, and the remainder receiving a partial response.~      This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or~     anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to~     surgery. The tumor from these patients will be tested to determine whether response to~     neoadjuvant chemoradiation can be accurately predicted.~   "
50338|NCT02398227|"~     This is a study comparing a new treatment (HOPE) to supportive therapy in the treatment of~     PTSD in residents of battered women's shelters.~   "
49628|NCT02407535|"~     In this study the investigators aim to assess the diagnostic performance of intraoperative,~     ultrasonographic assessment of the surgical extracted uterus for determining myometrial~     invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection~     and final pathological report (gold standard). The investigators hope that intraoperative~     gross inspection of the extracted uterus might offer an additional intraoperative tool for~     assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least~     as good as pathological exam.~   "
49629|NCT02407522|"~     The purpose of this study is to thoroughly investigate how the interaction between black~     rice and human gut microbiota affects metabolic diseases, this study will recruit patients~     with Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50~     g/day) for 3 months to observe its effect on the development of MS. The focuses of this~     project are to elucidate how black rice consumption affects the composition and metabolism~     of intestinal bacteria as well as the development of MS, and to further analyze whether the~     changes in intestinal bacteria are associated with the changes in MS improvements.~   "
49630|NCT02407509|"~     RO5126766 will be administered initially as a single daily dose of 4mg using either a twice~     weekly dosing schedule (Monday-Thursday) or a 3 times per week dosing schedule~     (Monday-Wednesday-Friday). The daily dose will be given orally according to the dosing~     schedule. A cycle of treatment will comprise 28 days. In Part I of the study both the twice~     weekly and the three times per week schedules will be assessed. In the absence of dose~     limiting toxicities 6 patients will be recruited to each dosing schedule cohort. In the~     event of a DLT being observed in Part I of the study, a single dose reduction to 3.2 mg will~     then be instigated and up to 6 patients will be recruited to that dosing schedule at the~     lower dose. The optimal dosing schedule determined in Part I will be taken forward to Part~     II and 20 patients with tumours harbouring BRAF, KRAS and NRAS mutations will be enrolled.~   "
49631|NCT02407496|"~     The purpose of this study is develop a new assessment tool for Attention~     Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to~     discriminate between individuals with ADHD and healthy controls).~   "
49632|NCT02407483|"~     Laparoscopic simulation training with or without laser visual guidance -A randomised study~     which investigates if the use of laser visual guidance can help the novices to learn the~     laparoscopic skills.~   "
49633|NCT02407470|"~     RATIONALE: It has been shown that about 30% of patients do not respond to immunosuppressive~     therapy or experience recurrence, and graft rejection and graft-versus-host-disease (GVHD)~     decrease event-free survival to 30% to 50% in the alternative donor (matched unrelated,~     partially matched family member) transplantation. Although an overall and disease free~     survival of 85% to 100%, can be obtained in allogeneic blood or bone marrow stem cell~     transplantation using an human leukocyte antigen (HLA) matched sibling donor, only about 25%~     of patients have such a donor.~      PURPOSE: In an attempt to avoid GVHD, reduce earlier infection rate and decrease~     regimen-related toxicity while maintaining better engraftment, this study is to evaluate the~     effectiveness and safety of patient's own adipose-derived mesenchymal stem cell (AD-MSC) or~     AD-MSC transdifferentiated HSC (AD-HSC) transplant after an immunosuppressive regimen in~     treating patients who have severe aplastic anemia.~      The patient will be in the study for one year for observation and active monitoring. After~     treatment and active monitoring are over, the patient's medical condition will be followed~     indefinitely. The principle measures of safety and efficacy will be :~        1. Patient survival probability at 3 months, 6 months and 1 year.~        2. Engraftment at 3 months, 6 months and 1 year~        3. Incidence of graft versus host disease (GVHD), incidence of acute and chronic GVHD and~          Incidence of earlier infection rate as well as other complications within 6 months and~          1 years.~   "
49634|NCT02407457|"~     The objective of this post-market study is to evaluate Endologix AFX endovascular AAA system~     with anatomical fixation against other approved Endovascular systems with proximal fixation.~     Multiple U.S clinical centers will be involved in the study to include a broad range of~     experience. Imaging data will be evaluated by an independent core lab.~   "
49635|NCT02407444|"~     This study aims to evaluate whether a combination of cycling training as part of~     physiotherapy treatment will contribute more than conventional physiotherapy treatment for~     elderly patients after hip fracture surgery in their subacute phase of rehabilitation.~   "
49636|NCT02407431|"~     The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical~     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer~     questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers,~     and other stakeholders.~   "
49637|NCT02407418|"~     The purpose of this study was to investigate the effects of chiropractic low back~     adjustments on thigh muscle strength. Force production was measured during different types~     of muscle contractions with a device called an isokinetic dynamometer. The study included 21~     college-aged subjects who did not have any pain and had never received chiropractic~     treatment with spinal manipulation. During two separate sessions, subjects' thigh muscle~     forces were recorded while performing maximal muscle contractions on the isokinetic~     dynamometer. Baseline measurements of muscle force were acquired before either treatment~     form of spinal manipulation or a sham spinal manipulation, followed by identical muscle~     force measurements within five and twenty minutes post-treatment.~   "
49638|NCT02407405|"~     This phase II trial studies how well selumetinib works in treating patients with~     neurofibromatosis type 1 and plexiform neurofibromas (tumors which arise from the nerves)~     that cannot be removed by surgery (inoperable). Selumetinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
49651|NCT02407236|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab as~     intravenous (IV: into the vein) infusion in induction study in participants with moderately~     to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in~     maintenance study in participants with moderately to severely active Ulcerative Colitis (UC)~     who have demonstrated a clinical response to Induction treatment with IV ustekinumab.~   "
49652|NCT02407223|"~     The purpose of this study is to assess the efficacy and safety of ustekinumab in adult~     participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the~     reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).~   "
73864|NCT02090530|"~     Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing~   "
49639|NCT02407392|"~     Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people~     in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which~     only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the~     stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the~     current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from~     the Barrett's oesophagus every two years. The large number of biopsies required is time~     consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the~     non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early~     detection of cervical dysplasia and cancer, and has also been used with success in a high~     risk Barrett's population (patients with suspected dysplasia or previously treated~     dysplasia), but not been studied in the lower risk Barrett's surveillance population. A~     diagnostic study of non-targeted mapping biopsies (current practice) versus targeted~     biopsies (acetic acid) in a surveillance population is needed before widespread adoption of~     this technique is possible.~   "
49640|NCT02407379|"~     The purpose of this study is to compare the efficacy of photoablative and photodynamic diode~     laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of~     periodontitis.~   "
49641|NCT02407366|"~     The current standard of care for unresectable locally advanced non-small-cell lung cancer~     (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard~     regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the~     first self-developed small molecular drug in China for targeted therapy of lung~     cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in~     Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised,~     multi-center, controlled trial is designed to assess the efficacy and safety of icotinib~     with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in~     inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is~     progression-free survival.~   "
49642|NCT02407353|"~     This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo~     controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of~     single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling~     methodology.~   "
49643|NCT02407340|"~     This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new~     medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and~     women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial.~     Participants will complete an 7-day inpatient protocol. During the first 3 days of the~     inpatient protocol, participants will complete alcohol abstinence in which withdrawal~     symptoms are measured,and urine will be collected to determine withdrawal symptom severity~     and urine levels of the stress hormone cortisol. Participants will then complete 3~     laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and~     3) subjective and physiological effects of alcohol. Finally, because participants are~     individuals with AUD, we will administer a brief intervention to address their risky alcohol~     drinking and problems before discharge.~   "
49644|NCT02407327|"~     The purpose of this study is to determine the percentage of CTC-positive patients and total~     CTC numbers in patients with advanced Non Small Cell Lung Cancer .~   "
49645|NCT02407314|"~     This is an interventional study assessing the effectiveness of Ticagrelor on the reduction~     of thrombus burden using optical coherence tomography in patients undergoing peripheral~     artery stenting.~   "
49646|NCT02407301|"~     This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF)~     adduction and abduction angles during voluntary cough to examine the effects of changes in~     glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study~     is that the incomplete glottal closure due to reduced vocal fold mobility will result in~     changes in true vocal fold adductory and abductory angles during cough and will result in~     changes to voluntary cough airflow parameters. This study results will contribute to the~     existing knowledge of the laryngeal contribution to cough airflow dynamics.~   "
49647|NCT02407288|"~     The purpose of this study is to determine whether tDCS is effective as an add-on treatment~     in SSRI-resistant patients with obsessive and compulsive disorder~   "
49648|NCT02407275|"~     To analyse and describe sinus microbiota, during hard to treat (or refractory)~     rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different~     medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA~     contained in samples).~      Samples are middle meatus swabs or pus aspiration, done during usually patient following.~   "
49649|NCT02407262|"~     Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal~     product that has a wide range of medical claims (including asthma) that originate from~     different historical backgrounds. Today in the era of Evidence-based medicine, it is hard to~     accept those traditional medical claims of medicinal plants without valid scientific~     experiments. Thus, randomized clinical trials is important to rational the uses of herbal~     products.~      Asthma is a common chronic disorder of the airways, characterized by variable reversible and~     recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and~     underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic~     diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014~     considered Asthma as an epidemic disease probably affecting about 334 million people~     worldwide and becoming a global health priority.~      This project investigates the use of herbal products to enhance asthma control in Saudi~     Arabia. In this context, Black Seed is one of the common herbal products used traditionally~     for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10%~     of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some~     pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed~     in Asthma and its underlying causes~   "
49650|NCT02407249|"~     This is a control registry to the E-FIRM registry to track conventional atrial fibrillation~     (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for~     the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as~     pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard~     routine of the center.~      Data items will be collected, if available, consistent and applicable with routine and~     standard clinical care at each participating site.~   "
49654|NCT02407197|"~     Myocardial fibrosis is the fundamental substrate for the development of heart failure.~      Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial~     fibrosis based on late gadolinium enhancement (LGE) and T1 mapping.~      Patients: Prospective longitudinal observational multicenter study of consecutive patients~     with suspected or known non-ischemic cardiomyopathy.~      Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume~     fraction (ECV) and LGE.~      Primary endpoints: all cause and cardiovascular mortality.~      Secondary endpoints: arrhythmic composite and HF composite endpoints.~   "
49655|NCT02407184|"~     Understanding the microbiome's important role in human health, the investigators wish to~     determine how the development of the infant microbiome is impacted by delivery mode,~     comparing natural vaginal birth to scheduled C-sections. Investigators will look at the~     oral, nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to~     age 1.~   "
49656|NCT02407171|"~     This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation~     Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients~     who progress on this antibody. Patients with metastatic melanoma will be enrolled after they~     have progressed on anti-PD-1 therapy. Patients with metastatic NSCLC (previously untreated~     with anti-PD-1 or anti-PD-L1 therapy) will be enrolled and treated with MK-3475 until they~     exhibit progression of disease. At this point (when patients have demonstrated progression~     of disease) a single target lesion will be selected and treated with SBRT, and then MK-3475~     will be restarted and continued until there is further progression of disease. The first~     phase of the study is a radiation dose escalation with a constant dose of MK-3475. The~     second part of the study includes expansion cohorts of NSCLC and melanoma patients.~   "
49657|NCT02407158|"~     The investigators will compare the response to oral endotracheal tube repositioning as~     measured by chest x-ray and measured by the air-wave device.~   "
49658|NCT02407145|"~     This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene~     fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of~     stress urinary incontinence in women. Women who are having a retropubic PVDF midurethral~     sling for urodynamic stress incontinence will be followed up for 24 months to address its~     efficacy and rate of complications.~   "
49659|NCT02407132|"~     The investigators will conduct a comparative effectiveness evaluation using a randomized~     control trial design of the adapted Family Model of Diabetes Self-Management Education~     (DSME), and compare results of the Family Model of DSME with traditional DSME within the~     Marshallese population. The family model will cover the same concepts as the traditional~     format. However, the family model will incorporate culturally-adapted education and~     recommendations aimed at engaging family members in the management of the primary~     participant's diabetes, and family members will be invited to fully participate in the~     study. By contrast, the traditional model provides diabetes self- management education to~     the diabetic participant only, and the participant's family members do not participate in~     the classes or any other part of the study. Biometric and survey data will be collected~     pre-intervention, post-intervention, 6 months post-intervention, and 12 months~     post-intervention. A qualitative debriefing session will be held for each family between the~     final DSME session and the 6 month post-intervention to obtain qualitative data regarding~     the participant's perceptions of the intervention and implementation process.~   "
49660|NCT02407119|"~     This study evaluates whether Helicobacter pylori eradication improves precancerous lesions~     including glandular atrophy and intestinal metaplasia as well as new cancers or dysplasias~     after endoscopic mucosal resection for gastric cancer.~   "
49661|NCT02407106|"~     The purpose of this study is to determine whether daily treatment with Streptococcus~     Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an~     episode of rheumatic fever.~   "
49662|NCT02407093|"~     Although soldiers must be ready to respond to occupational and war theatre demands at a~     moment's notice, there is an epidemic of overweight and obesity and a need for improved~     fitness and health in the military. Using a cluster randomized clinical trial we propose to~     test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention~     to improve the body composition and fitness of active duty military personnel. The~     effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness~     Training. Main outcomes will include changes in body composition and traditional fitness~     measures, a test of combat-preparation, and measures of cardiovascular health risk for both~     groups.~   "
49663|NCT02407080|"~     This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera~     (PV). ET causes people to produce too many blood cells called platelets and PV causes too~     many platelets and red blood cells to be made. Platelets are particles which circulate in~     the blood stream and normally prevent bleeding and bruising. Having too many platelets in~     the blood increases the risk of developing blood clots, which can result in life threatening~     events like heart attacks and strokes. When the number of red blood cells is increased in PV~     this will slow the speed of blood flow in the body and increase the risk of developing blood~     clots.~      The purpose of Part A of this study is to test the safety and tolerability of drug RG7388~     patients and identify the recommended phase II dose in a single agent dose escalation study.~     The investigators want to find out what effects, good and/or bad it has on the disease.~      The purpose of Part B of this study is to test the safety and tolerability of the~     combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from~     Part A who did not achieve at least a partial response by the end of three cycles of single~     agent RG7388.~      Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to~     treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative~     control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and~     apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous~     Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for~     patients who have Chronic Hepatitis B (CHB).~      RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the~     treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug~     that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in~     combination with Pegasys is experimental.~   "
49664|NCT02407067|"~     This study will compare two types of assistive devices for communication (a voice amplifier~     and a personal communication system) in individuals with a speech disorder related to~     Parkinson's disease. The performance of these two devices will be examined with measures of~     speech intelligibility and patient questionnaires and rating scales.~   "
49665|NCT02407054|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY3023414 in combination with enzalutamide in men with prostate cancer.~   "
49666|NCT02407041|"~     Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to~     severe plaque psoriasis~   "
50360|NCT02397941|"~     Purpose of the study is the assessment of interrectal distance and dimensions of the muscles~     of the lateral abdominal wall in pregnant and non-pregnant women~   "
49667|NCT02407028|"~     The purpose of this innovative adaptive phase II trial design is to determine the optimal~     hyperbaric oxygen (HBO2) treatment paradigm to be instituted in terms of atmospheric~     pressure, frequency of treatment and whether normobaric hyperoxia (NBH) following HBO2~     treatments enhances the treatment effect.~   "
49668|NCT02407015|"~     This study aims to examine the specific effect that 3D game play has on the control of the~     eyes horizontal movements. It will examine the youngest group of consumers this technology~     is marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to~     this study as per Nintendo's hardware guidelines, which recommends that children under 7~     years of age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes~     on horizontal fusional amplitudes compared with a control group playing in 2D for 30~     minutes.~   "
49669|NCT02407002|"~     The purpose of this study is to quantify the risk of hypotension due to field treatment with~     nitroglycerin in patients with ST-elevation myocardial infarction, particularly right~     ventricular infarcts, and secondarily to evaluate the benefit to pain relief..~   "
49670|NCT02406989|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of~     MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics.~     Subjects are dosed for 14 days.~   "
49671|NCT02406976|"~     This objective study to verify the effect of physical training with and without behavioral~     cognitive therapy, compared with controls, in functional capacity and cardio-metabolic~     profile in individuals with morbidly obese~   "
49672|NCT02406963|"~     A pilot research study is planned to occur within the pediatric urology service the spring~     of 2015. All pediatric urology patients in the immediate post-operative period of 0-14 days~     will be eligible for this study. This study will compare the current standard of care for~     managing post-operative complications (a telephone conversation with the NP) versus an~     experimental intervention (telephone call and an electronic photograph of the surgical~     site). Before the surgical patient is discharged from the hospital, consent will be obtained~     for participation. Once a family initiates contact with the NP with a post-operative concern~     they will be randomized to either the control or the experimental group. Those in the~     control group will receive the current standard of care, which is telephone advice only.~     Those in the experimental group will speak to the NP on the telephone and will be requested~     to send an electronic photograph of their child's surgical site to the NP for assessment and~     advice. Photographs will be assessed using a standardized tool by both NPs and this~     information will be entered into a database. The investigators will be measuring the number~     of emergency department (ED) and/or unplanned clinic visits in both groups. An unplanned~     clinic visit is defined as a visit that is required due to an unexpected complication or~     concern before the original scheduled post-operative follow-up as determined by the surgeon.~     The investigators will be tracking the number of follow-up phone calls for both groups, as~     well as requiring participants to complete a family/patient experience survey after speaking~     to the NP.~   "
49673|NCT02406950|"~     Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal~     ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects~     against endothelial dysfunction induced by IR injury in humans.~   "
49674|NCT02406937|"~     180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed~     in study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3~     groups, including breast feeding, commercial and new formula group. Study intervention is 12~     weeks.~   "
49675|NCT02406924|"~     Twenty four patients with bone resorption on the anterior maxilla will be divided into two~     groups with different kinds of grafting: bone block associated with particulated biomaterial~     and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane~     and pins. The techniques will be compared according to volume gain, quality of graft~     osseointegration, implant survival and maintenance of the level of soft tissues.~   "
49676|NCT02406911|"~     Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD)~     is still challenging because of bleeding and thrombotic complications. The investigators~     hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects~     compared with ticagrelor twice a day dose in ESRD patients on HD.~   "
49677|NCT02406898|"~     Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma.~     Limit of this technic is duration of procedure which is correlated to operative~     complications. So, for patient with large fibrome or several fibromas, this technic is not~     indicated or performs in several times. A new technic of hysteroscopic surgery is available~     which is quicker than conventional technic. This technic is poorly evaluated. Aim of this~     study is to evaluate both technics on procedure duration.~   "
49678|NCT02406885|"~     The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of~     apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE)~     prophylaxis and treatment) in the obese adult population to determine if bariatric surgery~     influences apixaban exposure. More interesting would be to see how the dose may need to~     change pre- vs. post-bariatric surgery (this will be important for physicians as more and~     more patients undergo this procedure worldwide and many may require anticoagulation in their~     future healthcare).~      Physicians and surgeons are very interested in oral anticoagulants for this special patient~     population. To date, there is no approved dosing for the obese patient (especially when~     considering surgical intervention such as bariatric surgery).~      Primary outcome variable.~      To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban~     in patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two~     bariatric surgical procedures (pre-operative versus post-operative vertical sleeve~     gastrectomy or Roux-en-Y gastric bypass patients).~      Secondary outcome variables.~        1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric~          surgical patients who have undergone RYGB vs. VSG.~        2. To determine how the pharmacokinetics of the drug may differ when there is significant~          post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months~          following surgery versus those patients who have suboptimal weight loss following~          bariatric surgery (< 40% of estimated excess body weight).~   "
49679|NCT02406872|"~     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an~     intravenous general anaesthetic drug in operations and to determine its efficacy and safety~     profile comparing to propofol.~   "
49680|NCT02406859|"~     An injury to the spinal cord results in a number of secondary medical problems, including~     the inability to voluntarily control the bowels. Depending on the severity and location of~     the injury, remaining bowel function differs, and can include any combination of the~     following: constipation (prolonged stool retention), difficulty with evacuation (difficultly~     moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move~     the bowels). Most of the current medications and treatment options address problems of~     constipation and difficulty with evacuation, but there are few options for individuals who~     suffer from incontinency. In this study, the investigators propose to study, in detail,~     anorectal muscle function in individuals with spinal injury - the investigators will do so~     using new technology called high resolution manometry - which will present the investigator~     with a 3 dimensional representation of the pressure profile of the anorectal muscles as the~     subject attempts different maneuvers. A subgroup with representatives of all levels and~     completeness of injury and anorectal muscle function will be enrolled to participate in six~     weeks of biofeedback training to see if their bowel function can be improved. During these~     six weeks, the subjects will be asked to visit the laboratory twice a week in order to be~     trained by the research team on how to improve their anorectal strength and function in~     response to visual cues. After the six weeks, another manometry study will be performed.~     Subjects will then be sent home and asked to perform a series of home exercises for another~     6 weeks, after which they will asked to return for a third and final manometry study.~   "
49681|NCT02406846|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     pancreatic cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers.In view of these facts, We wanted~     to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of~     pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic~     cell(DC)-cytokine-induced killers(CIK) treatment, and we also compared the specificity with~     reverse transcriptase polymerase chain reaction (RT-PCR) method.~   "
49682|NCT02406833|"~     This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2,~     to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery~     outcome by prevention of excessive scarring and trabecular meshwork transformation.~   "
49683|NCT02406820|"~     HF001 is a prospective observational study utilizing non-invasive medical devices that may~     be able to discriminate changes in heart failure while acutely decompensated patients~     undergo routine interventional therapies in a hospital setting. Subjects will be monitored~     using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric~     handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to~     standard assessments of heart failure including pulmonary artery catheter (PAC) pressures,~     blood pressure (BP), patient symptoms, and physical exam findings. The results of this study~     will be used to develop a powered study to determine if a new configuration of non-invasive~     monitoring devices can be used to monitor heart failure status more sensitively than current~     non-invasive techniques.~   "
49684|NCT02406807|"~     High-Velocity Low-Amplitude (HVLA) manipulation is a known technique of the Osteopathic~     Manipulative Treatment (OMT) for somatic dysfunction (SD), and heart rate variability and~     H-reflex response are possible variables to assess its neurophysiological effects. Somatic~     dysfunction is an impairment or altered function of related components of the somatic~     system.~      Studies show a transient attenuation of α-motor neuron excitability after HVLA manipulation~     in asymptomatic participants. According to studies, HVLA spinal manipulation increases joint~     mobility by blocking afferent impulses in the muscle spindle and the small-diameter free~     nerve, decreasing the γ-motor neuron activity.~   "
49685|NCT02406794|"~     Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than~     tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the~     side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study~     aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia~     and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve~     their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various~     points in order to improve symptoms and increase adherence.~      Methods/Design: The study includes 156 breast cancer survivors treated with endocrine~     therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la~     Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such~     treatment. Clinical and patient data were obtained from medical histories, genetic and~     proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of~     interest, their VAS. NMT is applied in four possible locations, according to the symptoms of~     each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several~     more interventions before repeating the readings from the last five weeks of the start of~     the study.~   "
49686|NCT02406781|"~     This is a multicenter study assessing efficacy of the MK 3475 (Pembrolizumab) in combination~     with metronomic cyclophosphamide in patients with advanced sarcomas.~   "
49687|NCT02406768|"~     To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to~     use this group to compare the neurodevelopmental changes over time to the HIV-infected~     children with and without HAART (main study).~   "
49688|NCT02406755|"~     Randomized clinical trial about self-care mediated by the senses in female health~     professionals and their influence on stress, self-esteem, mood states, life satisfaction and~     levels of salivary cortisol.~   "
49689|NCT02406742|"~     Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with~     ibrutinib and obinuzutumab.~      CC-122 has multiple activities, including immune modulation of several immune cell subsets~     and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety~     profile with some preliminary signs of efficacy with early human experience.~   "
49700|NCT02406599|"~     The study objective is to determine the MarginProbe® System's diagnostic accuracy at the~     margin level and impact on Positive Margin* Presence originating from the Main ex-vivo~     lumpectomy specimen after the initial lumpectomy surgery.~      *A positive margin is defined in this study as a margin microscopically measured and~     reported in the histology report to have cancer within 1 mm or less of the inked surface~   "
49690|NCT02406729|"~     This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that~     will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue~     vaccine produced by Butantan Institute.~      The study will be carried out in multiple sites in Brazil. The study will be community-based~     in select urban areas where there's dengue transmission.~      Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a~     ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days~     post-vaccination in the entire population of 16944 participants.~      For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys~     and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The~     age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21~     days after vaccination is analysed for 450 participants in 7-to17-ys age group, the~     following group, of 2 to 6 ys, will start.~      The study's hypothesis is that the vaccine under investigation and produced by Butantan~     Institute is safe and provides protection against dengue symptomatic disease of 80% or more~     with a lower bound of the 95% confidence interval of 25%. This way, the expected number of~     dengue cases virologically confirmed is 24 or more which will provide a response in terms of~     vaccine efficacy.~      All participants will be followed up for five years to verify dengue incidence, regardless~     severity.~   "
49691|NCT02406716|"~     This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients~     with heart failure. Study protocol:~      Hospitallized patients with new onset or previously diagnosed heart failure will be~     recruited to the study. Control group will include healthy people with no medical records or~     chronic treatment at the same age range. After signing an informed constent form, full~     medical history and blood samples will be collected. A second blood sample will be collected~     8 weeks later, assuming the patient was discharged and not hospitalized since than. The~     blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above~     semaphorins levels in the heart failure group and control group. Statistical analysis will~     then commence for possible correlatoion with different clinical parameters.~   "
49692|NCT02406703|"~     Background and Objectives Short acting regional anesthetics have already been successfully~     employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact~     on direct and indirect perioperative costs comparing two different short-acting local~     anesthetics has not been performed, yet.~      Methods In an observational study including 50 patients per group, patient undergoing~     popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery~     were compared. The primary outcome was the saving of both direct and indirect perioperative~     costs. Secondary outcomes were block success, onset time and block duration, patient~     satisfaction and unplanned outpatient visits or readmissions after discharge.~   "
49693|NCT02406690|"~     The purpose of this study is to determine the differences that exist in RNA molecules, the~     biochemical process of methylation, and estrogen receptor binding in patients that have~     failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to~     patients whose endometrium thickness is within normal limits.~   "
49694|NCT02406677|"~     Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test~     the impact of copayment reduction on clinician choice of medication, patient adherence, and~     clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized~     clinical trial that will assess the impact of copayment reduction by equalizing the~     copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient~     medication adherence, and clinical outcomes up to one year. We hypothesize that reducing~     out--of--pocket cost for P2Y12 receptor inhibitor will lead to improved adherence.~     Additionally, copayment reduction of both generic and brand antiplatelet agents may lead to~     a reduction in MACE risk. This is in part due to greater adherence to an evidence--based~     secondary prevention medication. Additionally the reduction in MACE may reflect greater~     selection of a more potent antiplatelet agent that has been shown to reduce MACE in~     randomized clinical trials, as provider choice of antiplatelet therapy will be primarily~     driven by risk- benefit assessment rather than the cost burden to the patient.~   "
49695|NCT02406664|"~     The purpose of this study is to determine the change in kidney function and blood pressure~     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly~     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24~     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical~     treatment.~   "
49696|NCT02406651|"~     A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of~     F-652 in combination with systemic corticosteroids in subjects who have undergone~     Hematopoietic Stem Cell Transplantation (HSCT) and have newly diagnosed grade II-IV lower GI~     acute Graft Verses Host Disease (aGVHD). Treatment with F-652 will be once a week for 4~     weeks, with post treatment follow up visits on days 28, 56, 180 and 365.~   "
49697|NCT02406638|"~     Compare through 3D USG the tape spatial orientation, in three different techniques of~     insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results~     in an average of three years follow-up.~      Methods: This is a transversal study of a cohort women surgically treated for stress urinary~     incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision~     sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit,~     from April 2013 to June 2014, .~   "
49698|NCT02406625|"~     Suicidal behaviors among adolescents represents a public health problem due to its high~     prevalence and its low predictability. It is also known that brain development continues~     during adolescence, therefore, a therapeutic intervention during this period might~     propitiate neural changes that might favor the emotional regulation involved in suicidal~     behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem.~      For this reason, the investigators aimed to study the clinical, neuropsychological and~     neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.~   "
49699|NCT02406612|"~     The study is designed to prospectively collect data on and confirm the safety and~     effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and~     time to ambulation for patients who have undergone diagnostic or interventional~     catheterization procedures using up to 6F sheaths when compared with standard compression~     techniques using data from literature surveys.~   "
51840|NCT02378584|"~     This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in~     natural or artificial cycle.~   "
49701|NCT02406586|"~     The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated~     inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty~     acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and~     oxidative stress, and autonomic dysfunction in obese normotensive subjects.~   "
49702|NCT02406573|"~     This pilot study will evaluate the use of nominal stimuli to assess dentinal~     hypersensitivity response relative to a clinically-controlled stimulus.~   "
49703|NCT02406560|"~     Each subject will be given tafamidis after either a high fat meal or while fasted. After~     swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one~     week. After about 14 days, subjects will take either a different dose of tafamidis or the~     same dose under the opposite meal condition. Tafamidis concentrations from the three~     different conditions will be compared to determine if they are approximately the same.~   "
49704|NCT02406547|"~     This study is designed to evaluate the utility of Narrow Band Imaging (NBI) compared with~     High Definition White Light colonoscopy (WLE) in subjects with serrated lesions who do not~     fulfill the diagnostic criteria of Serrated Polyposis Syndrome (SPS).~   "
49705|NCT02406534|"~     This is an observational study to evaluate the relationship between pulmonary function and~     the patient reported health-related quality of life (HRQoL) and chronic obstructive~     pulmonary disease (COPD) related admissions. Patients with COPD will be approached to~     participate in the study. Pulmonary function will be measured on consented, eligible~     patients. The pulmonary function measurement collected will be used for cohort assignment.~     The prospective follow up period will monitor the cohorts for evidence of readmission and to~     assess HRQoL.~   "
49706|NCT02406521|"~     This research study is comparing different drug combinations as a possible treatment for~     metastatic renal cell carcinoma (mRCC) and bone metastases.~      The names of the study interventions involved in this study are:~        -  Combination of Radium-223 and Sorafenib~        -  Combination of Radium-223 and Pazopanib~   "
49707|NCT02406508|"~     This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and~     efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with~     unresectable hepatocellular carcinoma (HCC) confined to the liver.~   "
49708|NCT02406495|"~     Open label, 1-week daily disposable, dispensing study~   "
49709|NCT02406482|"~     This study will examine the efficacy of a combined HIV and microfinance intervention to~     reduce biologically confirmed sexually transmitted infections (STIs), and new incidence of~     HIV and HCV, as well as reported sexual and drug risk behaviors among 520 women who have~     injected drugs in the past year and who engage in sex trading in Temirtau and Pavlodar,~     Kazakhstan. The proposed study builds on findings from an R34 by the investigative team~     testing a combination HIV prevention and microfinance intervention. Building on successful~     protocols and significant results, we will randomly assign 520 women who inject drugs and~     engage in sex trading from Temirtau and Pavlodar, Kazakhstan to either (1) a 4 session HIV~     prevention intervention combined with a 6 session financial literacy intervention,~     enrollment in an existing vocational training program and receipt of matched savings~     (HIVRR+MF); or to the 4 session HIV prevention intervention alone. The HIVRR intervention is~     guided by social cognitive theory. The HIVRR+MF intervention integrates asset theory with~     social cognitive theory. The MF includes: 1) financial literacy; 2) vocational training; and~     3) micro-savings to support transition to a more permanent employment status. We hypothesize~     that increasing financial literacy, enhancing vocational skills required to fill marketable~     positions in the local economy, and beginning a personal savings program, combined with HIV~     risk reduction, will lead to significant reductions in study outcomes compared to an HIVRR~     intervention without a microfinance intervention.~   "
49710|NCT02406469|"~     This is a single-site, double-blinded, randomized, controlled, 2X2 cross-over study aiming~     to compare effects of milk containing only A2 type beta casein versus milk containing both~     A1 and A2 beta casein proteins on the gastrointestinal physiology, symptoms and cognitive~     behaviour for the health people who are intolerant to traditional cow's milk.~   "
49711|NCT02406456|"~     Participants will undergo a single session of functional magnetic resonance imaging~     (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their~     ability to regulate motivational networks of the brain during the exposure to alcohol cues~     and evaluate immediate effects on craving and cognitive bias for alcohol by administering a~     questionnaire and a Stroop task before and after the session.~   "
49712|NCT02406443|"~     Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4~     inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the~     mechanisms mediating the renal effects of DPP-4 inhibitors in humans.~      Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following~     short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in~     patients with type 2 diabetes and systolic hypertension.~      Design: double-blind, randomized, placebo-controlled trial, Phase IV.~      Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood~     pressure ranging from 120-160 mmHg.~      Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to~     placebo (1 tablet daily) for 28 days.~      Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.~   "
49713|NCT02406430|"~     Retrospective interventional case series study reporting preoperative clinical and~     anatomical factors associated with visual recovery 1 year after combined cataract and~     idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best~     corrected visual acuity appeared to be reliable prognostic factors. Combining these factors~     with analysis of the photoreceptors' inner and outer segments junction in spectral-domain~     optical coherence tomography provides a predictive score to estimate individual chances of~     good visual recovery~   "
49714|NCT02406417|"~     Early detection and management of pituitary dysfunction reduces the morbidity that ensues as~     a consequence of missed or delayed diagnosis of this condition, and which may result in~     life-threatening events and increased mortality.~      The investigators study will explore the use of reflex strategies within the laboratory in~     capturing suspicious pituitary function test results from Primary Care patients and~     following these up with appropriate reflective testing. Subsequently patients identified~     from these results to have a possible underlying piuitary dysfunction will have an alert~     sent to their family physician prompting referral to the Endocrine team for further~     investigation and management.~   "
49715|NCT02406404|"~     This study was designed to examine the effect of incentive spirometry in pulmonary~     rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can~     help improve breathing and strengthen inspiratory muscles. If the patient assigned to~     training group, the subjects started to respiratory muscle strengthening exercise using~     incentive spirometry. The training was performed ten sessions daily, for 4 weeks.~     Respiratory function tests including forced vital capacity, forced expiratory volume in 1~     second, Peak cough flow, maximal phonation time were compared before interventions and at~     the end of exercise.~   "
49716|NCT02406391|"~     In the United States, the highest incidence of cervical cancer occurs in inner city urban~     centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of~     this study is to study predictors of adherence among patients seeking care at an inner city~     medical center in New York City and the U.S. Mexico border for cervical cancer prevention,~     namely, Pap smears and colposcopy exams.~   "
49717|NCT02406365|"~     A handheld digital colposcope which utilizes flurorescent light is being tested for the~     rapid detection and management of cervical lesions. The handheld research device captures~     cervical images which with the fluorescent light show the regions of cervical tissue that~     autofluoresce. The investigators will study the relationship between the level of~     fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her~     routine care. The investigators will also compare the efficacy of the hand held device with~     the data being collected from the other research devices being tested by the team, i.e. the~     multispectral digital colposcopes.~   "
49718|NCT02406352|"~     Although cervical cancer is a preventable cancer, every year more than one-quarter of a~     million women die worldwide from this disease. Internationally and nationally, cervical~     cancer is a disease that affects predominantly women who are poor and who live in resource~     poor settings. With the device the investigators are developing, known as the Multispectral~     Digital Colposcope with probe, our goal is to make detection of precancerous cervical~     lesions easier for the patient and for her provider. For the patient, our goal is to reduce~     the number of clinical visits needed to obtain a diagnosis and treatment and consequently to~     reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For~     the provider and the health care system, our goal is to obtain a more accurate diagnosis~     than the currently available diagnostic methods.~   "
49719|NCT02406339|"~     This study evaluates the effect of training with neuromuscular electrical stimulation (NMES)~     associated with vascular occlusion of the lower limbs, for increased strength and~     hypertrophy of the quadriceps muscle of professional basketball athletes.~   "
49720|NCT02406326|"~     This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10~     patients per centre involving approximately 25 centres). Patients will be followed up~     clinically for twelve months post-procedure at 1 month, 6 months & 12 months. All patients~     will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years~     3 & 5 post-implant.~   "
49721|NCT02406313|"~     The study evaluates the efficiency, in terms of quality of life improvement, of a patient's~     therapeutic education program (ETP), based on long term commitment in adapted physical~     activities carried out during a standardized thermal cure (CTS) for fibromyalgia among~     patients continuing regular drug treatment or not~   "
49722|NCT02406300|"~     This study evaluates the effect of anesthesia on mortality after surgical repair of proximal~     femur fracture.~      Patients will receive either a subarachnoid block or a combination of peripheral nerve~     blocks and light general anesthesia (PNB/GA).~      The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid~     free light anesthesia may have more favourable outcomes.~      Both groups will be followed up for assessment of post-operative morbidity and mortality.~   "
49723|NCT02406287|"~     To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor~     dynamics relative to its placebo.~   "
49724|NCT02406274|"~     Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is~     performed after injection of contrast or dye into a vein in the arm. This dye is the same~     dye that is used for CT scans. This type of mammogram includes a regular mammogram as well~     as additional pictures with the dye.~      This particular study is being done to determine if by adding the dye in the veins the~     investigators are better able to identify the cause of the lump than if they just did the~     regular mammogram alone.~   "
49725|NCT02406261|"~     The purpose of this study is to study the effect of AZD3293 on how the body absorbs and~     processes 3 other medications, midazolam, simvastatin and donepezil and how these 3~     medications affect AZD3293 when they are taken together. This study is in 2 groups, group A~     is approximately 44 days long and group B about 70 days only. The screening visit is~     required within 30 days prior to the start on the study~   "
49726|NCT02406248|"~     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the~     cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with~     non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles~     are depolarized) elevation myocardial infarction~   "
49727|NCT02406235|"~     The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic~     counselling quality and satisfaction with a new onco-genetic BRCA testing model.~   "
49728|NCT02406222|"~     This study is determining whether the addition of cyclophosphamide to pomalidomide and~     dexamethasone improves progression free survival in patients with relapsed refractory~     myeloma (RRMM) compare to pomalidomide and dexamethasone alone. Patients will be randomised~     on a 1:1 basis to receive CPD or Pd. Treatment will be continued until disease progression~     or unacceptable toxicity.~   "
49729|NCT02406209|"~     This is a randomized, multi-center, investigator masked, comparator controlled study. The~     purpose of this study is to determine the efficacy and safety of NS2 in patients with~     non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple~     doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.~      Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a~     small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.~   "
49932|NCT02403544|"~     This is a phase I study to evaluate the safety of concurrent chemoradiation combining~     radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with~     advanced or inoperable hepatocellular carcinoma.~   "
49730|NCT02406183|"~     The prognosis of advanced metastatic melanoma remains poor although a breakthrough has been~     achieved with the novel anti-CTLA-4 treatment (ipilimumab) for a subset of patients.~     Unfortunately, due to immune resistance, the majority of patients do not obtain long-lasting~     clinical benefit. Radiotherapy is able to interfere with immune resistance by inducing~     immunogenic cell death. Preclinical evidence indicates that combining radiotherapy with~     anti-CTLA-4 treatment increases response rates compared to single agent treatment. These~     data are supported by several spectacular clinical cases and one retrospective study. The~     investigators hypothesize that combining ipilimumab with radiotherapy will result in a~     higher response rate compared to ipilimumab or radiotherapy in monotherapy. Given the~     complexity of the interaction in anti-tumor immunity, the first goal of this project is to~     assess the safety of the combined treatment.~   "
49731|NCT02406170|"~     Patients with advanced oesophagogastric cancer (OCG) have a very poor prognosis. After~     progression on first line therapy, second line chemotherapy with paclitaxel and a VEGF-R2~     targeting antibody has a proven benefit on survival. However, no data are available on the~     combination of paclitaxel with kinase inhibitors in advanced OGC. Here the investigators~     propose a Phase 1b study to assess the tolerability of regorafenib (an oral multi kinase~     inhibitor) in combination with paclitaxel and to assess the uptake of paclitaxel in OCG~     metastasis.~   "
49732|NCT02406157|"~     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic~     efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema~     compared with 532 subthreshold laser photocoagulation.~   "
49733|NCT02406144|"~     This protocol is a randomized, open-label, national, multicenter trial studying maintenance~     treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708~     after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed~     symptomatic multiple myeloma.~      A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study.~      The pre-treatment period includes the screening visit in which participants provide informed~     consent in writing in order to take part in the study. The patient is then assessed to~     determine his/her eligibility. The selection process will begin 21 days before the first~     dose of medication is administered (days -21 to 0). All procedures during the pre-treatment~     period will be carried out after completion of the two cycles of post-transplant~     consolidation with VRD which coincide with the end-of-study visit of clinical trial~     GEM2012MENOS65.~      During the treatment period, eligible patients will be included in the study and receive~     maintenance treatment with lenalidomide/dexamethasone versus~     lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will~     consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day~     of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B~     of the maintenance treatment will be the same as arm A, with the addition of MLN9708 during~     the two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle.~      At two years, patients with negative MRD will finish maintenance treatment. Patients with~     positive MRD will continue treatment with lenalidomide/dexamethasone until they have~     completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will~     only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be~     adjusted. (unless necessary to treat adverse events)~      Once this phase of active treatment is complete, patients will begin the long-term follow-up~     phase, during which they will be visited every three months to evaluate progression and~     survival.~   "
49734|NCT02406131|"~     The investigators will established relation between restenosis and inflammatory response to~     shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory~     response can consequently affect the restenosis rate. There is accumulated evidence that~     remote ischemic precondition has modifying suppressive effect on inflammatory response and~     the investigators hypothesized that RIPC may lead to reduction in post angioplasty~     restenosis rate.~   "
49735|NCT02406118|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision.~   "
49736|NCT02406105|"~     Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife~     based functional radiosurgery for Parkinson disease patients suffering from tremor.~   "
49737|NCT02406092|"~     Safety Study of Rituximab in Patients with Non Hodgkin Lymphoma (DLBCL & FL)~   "
49738|NCT02406079|"~     Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed~     to determine whether tracheotomy influences PCT concentrations in patients without sepsis,~     and to assess whether operative duration and procedure affect the peak PCT level.~   "
49739|NCT02406066|"~     This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and~     oxazepam) in otherwise healthy adults who are regular cigarette smokers. There will be 3~     groups of 8 subjects; in each group, 6 subjects will get the drug combination and 2 will get~     placebo. Neither the subjects nor the study personnel will know who got drug and who got~     placebo (double-blind). In the first group the drug doses will be low, and they will be~     increased in the second and third groups. Subjects will receive a single dose on Day 1,~     followed 24 hours later by the start of doses twice daily for 7 days, and then a final~     morning dose on the last day. The levels of the drugs in the blood will be assessed by~     repeated blood draws after the first day and after the end of dosing. Safety will be~     assessed after the single dose and repeated dosing. Effects of study drug on smoking and~     craving cigarettes will be assessed at the end of repeated dosing. The hypothesis is that~     this drug combination will be safe, with relatively few side effects.~   "
49740|NCT02406053|"~     The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory~     cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is~     a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive~     pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current~     evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and~     progression of respiratory diseases. The major exposures that cause OS can be summarized as~     smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic~     diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall~     outcome of pulmonary OS is increased mortality due to increased incidence of respiratory~     diseases [9].~   "
49741|NCT02406040|"~     Weight loss through energy restriction results in the loss of both fat and muscle mass.~     Muscle mass is important for mobility, strength, glucose control and energy expenditure, and~     therefore the retention of muscle mass during energy restriction is an important goal. The~     retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and~     muscle protein breakdown (MPB). It is well known that MPS is reduced during weight loss,~     however the effect of weight loss on MPB is currently a topic of debate. The purpose of this~     study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on~     both MPS and MPB in order to gain insight into the mechanisms causing muscle loss during~     energy restriction. In addition, the effect of resistance exercise and protein (both known~     to preserve muscle mass) on MPS and MPB will be examined~   "
54484|NCT02343978|"~     The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic~     Constipation (CC) patients.~   "
49742|NCT02406027|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease~     that slowly destroys memory and thinking skills, and eventually even the ability to carry~     out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial~     with JNJ-54861911, who are willing to continue their assigned treatment.~   "
49743|NCT02406014|"~     This is a phase 4, multi-centre, randomized, two group, open label, active controlled,~     parallel group, 17 week trial.~   "
49744|NCT02406001|"~     The purpose of this randomized trial was to compare reconstructive surgery of advanced~     peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap~     debridement (OFD/Control) in a non-submerged technique over 6 months.~   "
49745|NCT02405988|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is~     required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics~     of naloxone in healthy volunteers under opioid influence.~   "
49746|NCT02405975|"~     This study will assess, by means of a randomized controlled trial, the impact of an online~     educational tool, on doctors' knowledge and confidence with regards to prescribing for older~     patients.~   "
49747|NCT02405962|"~     The purpose of this study is to examine whether a parental training program using~     group-based Acceptance and Commitment Therapy for childhood asthma care, is effective in~     reducing the number of children's unplanned health care services utilization and asthmatic~     symptoms.~   "
49748|NCT02405949|"~     Obesity is directly related to an increased risk of diabetes mellitus, hypertension,~     dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in~     decreasing these risks and to reduce disease severity. Bariatric surgery is an effective~     therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the~     morbidly obese patients. But there is also a significant number of individuals with an~     inappropriate response to bariatric surgery. Two recent retrospective studies assessed the~     role of genetic load as a predictor of this response, but the results are still~     unelucidated. The aim of this study is to assess whether a selection of genetic variants may~     allow us to identify individuals who will have a satisfactory response after bariatric~     surgery in terms of weight loss and T2D remission.~   "
49749|NCT02405936|"~     The aim of this prospective study is to collect data on patients undergoing gynecologic~     surgery at Kangbuk Samsung Hospital.~   "
49750|NCT02405923|"~     This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind~     intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice~     hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula~     for the management of Cow's Milk Protein Allergy (CMPA).~   "
49751|NCT02405910|"~     Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered~     in combination with gemcitabine, at two different dose combinations as first line therapy in~     patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer~     (NSCLC).~   "
49752|NCT02405897|"~     Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves~     multiple body organs. The diagnosis requires the presence of compatible clinicoradiological~     features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph~     nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that~     can be sampled by, performing various bronchoscopic techniques. In a recent study the use of~     alligator forceps had a better yield in comparison to cup forceps. The investigators~     hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup~     forceps will yield larger samples, thereby improving the diagnostic yield and reducing the~     number of biopsy samples irrespective of the stage of sarcoidosis.~   "
49753|NCT02405884|"~     Objective: To evaluate the variation in intraocular pressure in patients with chronic kidney~     disease, according to the time interval between hemodialysis sessions and to the influence~     of weight and blood pressure on intraocular pressure.~      Methods: This was a cross-sectional study in which 78 eyes of 39 patients on hemodialysis,~     at the Santa Casa de Misericordia de Goiânia hospital, were analyzed in June 2014. Patients~     were divided into groups according to the days on which they underwent hemodialysis. The~     mean, standard deviation, and median of the intraocular pressure, blood pressure, and weight~     were calculated. P-values <0.05 were considered statistically significant.~   "
49754|NCT02405858|"~     The purpose of this study is to evaluate the percentage of participants achieving~     prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to~     Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.~   "
49755|NCT02405845|"~     Hardened plaque located in the carotid arteries can cause stroke or transient ischemic~     attack (TIA). This type of plaque is linked to unstable free-floating thrombi (FFT). FFT are~     blood clots that form in a blood vessel, and are at the highest risk for travelling within~     the bloodstream and causing strokes. Physicians are able to see this type of plaque with~     computed tomographic angiography (CTA) but FFT look very similar to stable types of plaque~     that do not require urgent treatment.~      Distinguishing between these plaques is important because it affects the choice and urgency~     of treatment that patients receive.~      The researchers have found a promising visual marker on CTA scans. The goal of this study is~     to determine if this visual marker seen on CTA scans will help to distinguish FFT plaque~     from stable plaque.~   "
49770|NCT02405650|"~     Obesity and chronic kidney disease (CKD) are major public health problems. In contrary to~     observations in general population, higher body mass index in those with pre-existing CKD is~     associated with lower mortality. Chronic Renal Insufficiency Cohort (CRIC) is an ongoing~     observational study to examine the consequences of CKD with a particular focus on~     cardiovascular illness like myocardial infarction (heart attack) and stroke. Among CRIC~     study participants, the investigators propose to obtain visceral and subcutaneous adiposity~     and physical fitness measures and study its associations with patient-centered outcomes.~     This study will help the investigators understand the independent and combined effects of~     visceral adiposity and physical fitness on cardiovascular disease, renal disease progression~     and death among those with CKD. Further, it will identify mechanisms that could be targeted~     to reduce the detrimental effects of visceral adiposity in those with kidney disease.~   "
49756|NCT02405832|"~     The objective of this study is to assess the effect of preoperative administration of oral~     zinc lozenges on the incidence of postoperative sore throat syndrome.~      When patients undergo surgery with general anesthesia, they require ventilation of their~     lungs with the help of a flexible tube (called an endotracheal tube) that is placed through~     the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps~     oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to~     prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most~     common consequences is a sore and inflamed throat after the tube is taken out. This is~     termed postoperative sore throat (POST). Though the intensity and severity of sore throat~     varies from person to person, the reported incidence is as high as 90% of patients~     undergoing general anesthesia.~      Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold~     symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can~     act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal~     membranes (which cover the inside of the mouth and throat). The aim of this study is to~     evaluate the effects of giving zinc lozenges before tube placement on postoperative sore~     throat.~      After written informed consent is received in pre-op, a sealed and coded envelope with~     either the zinc lozenge or the placebo lozenge will be given to the patient to be~     administered orally, with the instruction to dissolve the lozenge by sucking on it 30~     minutes prior to surgery. Upon completion of surgery and emergence from general anesthesia,~     the patient will be extubated and transferred to the post-anesthesia care unit (PACU). Once~     in the PACU, the patient will be assessed regarding the incidence and severity of POST by~     the study investigator using a standardized scale. The severity of POST will be graded on a~     4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort~     (complains only upon questioning), 2 being moderate sore throat (complains on his/her own),~     and 3 being severe sore throat (change in voice, hoarseness, and throat pain). This~     evaluation will be performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery,~     with the assessment at 4 hours being the primary outcome of the study.~   "
49757|NCT02405819|"~     Objective: to describe and compare the implementation of two cancer survivorship care tools:~     (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a~     provider-initiated tool. The results of this study will be used to (1) provide an initial~     assessment of the two survivorship care planning tools and (2) inform the design and conduct~     of a larger study.~   "
49758|NCT02405806|"~     The overall aim for this study is to evaluate the clinical effects of a modified diet on~     metabolic risk factors such as diabetes mellitus and obesity, and the mechanisms this~     nutrition composition exerts on gastrointestinal physiology, inflammatory responses, and~     quality of life, where the subjects are their own controls.~      Within this study, the investigators will be able to relate the nutritional composition to~     metabolic disorders, the gut microbiota, secreted intestinal neuropeptides, and bio- and~     inflammatory markers in serum, plasma and urine.~   "
49759|NCT02405793|"~     The purpose of this study is to evaluate the safety and efficacy of a low dose and a high~     dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain~     due to osteoarthritis of the knee or hip.~   "
49760|NCT02405780|"~     The purpose of the study is to compare the safety, effectiveness and immunogenicity of~     FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study~     FKB327-002 and have inadequate disease control on methotrexate.~   "
49761|NCT02405767|"~     The BIPPED study seeks to determine whether wound healing, in particular diabetic foot~     ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the~     resistance of biological tissue to the passage of a very small electric current applied with~     electrodes. Different types of tissue, due to cell structure, hydration and vascularization,~     have specific electrical characteristics. The BIPPED study aims to provide experimental data~     for the development of a BIA sensor for monitoring of wound healing in chronic wounds.~   "
49762|NCT02405754|"~     This is a retrospective study, designed to be conducted at a single-center in the US. The~     study will conduct a one-time data abstraction from approximately 500 patient medical charts~     who received Corus CAD testing, by order of the Principal Investigator. Limited demographic~     data and patient data pertaining to cardiology referral or advanced diagnostic testing will~     be collected. All data will be collected anonymously.~   "
49763|NCT02405741|"~     Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in~     the tissues and has been proven to be beneficial in treating different ischemic wounds, and~     acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients~     yet.~   "
49764|NCT02405728|"~     The use of peripherally inserted central catheters (PICCs) represents a major advance for~     hematological patients, enabling the effective delivery of chemotherapy and/or blood~     products particularly for prolonged infusions or in situation of difficult venous access. In~     modern medical practice their use has increased rapidly for several reasons, including ease~     of insertion, many uses (e.g., drug administration and venous access), perceived safety, and~     cost-effectiveness compared with other central venous catheters (CVCs).~   "
49765|NCT02405715|"~     This study evaluates the addition of intranasal oxytocin to the treatment of Major~     Depression using interpersonal psychotherapy. Half of the participants will receive a~     placebo adjunct to interpersonal psychotherapy, and the other half will receive oxytocin.~   "
49766|NCT02405702|"~     The infection of a total knee replacement often imposes changing implants. The change in two~     step is currently considered the gold standard. The change in one step is a much debated~     attitude: strictly contra-indicated for some professionals, but others agree to reserve~     these for favorable suspected cases selected. Several criteria have been proposed in the~     literature: age, condition, duration of infection, known bacterium responsible, not virulent~     and sensitive to antibiotics, no fistula, no significant bone destruction. But these~     criteria are poorly validated, standing over an experience of surgical teams rather than~     high-level scientific studies. Some authors have proposed to achieve change in one step~     systematically. The results of these cohorts on healing the infection does not seem very~     different from the changes in two steps. But it is most often single-center series,~     uncontrolled, with small numbers.~   "
49767|NCT02405689|"~     The aim of this study was to investigate the myocardial protective effects of remifentanil~     and dexmedetomidine in cardiac surgery.~   "
49768|NCT02405676|"~     The purpose of this study is to test whether adding 4 injections of rituximab and increasing~     the intensity of chemotherapy regimens in advanced patients can improve the EFS compared~     with the historical study CCCG-NHL-2009.~   "
49769|NCT02405663|"~     To compare between the effect of controlled cord traction and manual removal of the placenta~     on blood loss among women undergoing caesarean sections~   "
49821|NCT02404987|"~     Post-marketing observational study of a nutritional care plan, including a higher calorie,~     higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free~     living and residing and nursing homes, who have been identified as malnourished. The~     objective is to assess the impact of the ONS on body weight, activities of daily living and~     quality of life.~   "
49771|NCT02405637|"~     The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and~     such swallowing is essential for normal small bowel development.Growth factors found in the~     amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As~     feeding intolerance is a common problem among premature neonates, the investigators will~     study the role of enteral administration of simulated amniotic fluid solution in prevention~     of feeding intolerance and NEC in premature neonates.~   "
49772|NCT02405624|"~     Patients with infantile onset Pompe disease will be trained with continuous positive airway~     pressure to see if hypernasality can be improved.~   "
49773|NCT02405611|"~     This study is a longitudinal controlled trial that is designed to investigate the~     effectiveness of a multi-component intervention on improving fruit and vegetable consumption~     in teenagers and their mothers.~   "
49774|NCT02405598|"~     evaluate if beta 2-adrenergic agonist can have adjuvant effect to patients with~     infantile-onset Pompe disease under enzyme replacement therapy~   "
49775|NCT02405585|"~     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most~     patients diagnosed with pancreatic cancer continue to die from the rapid progression of~     their disease. One primary reason for this is that the disease is typically without symptoms~     until significant local and/or distant spread has occurred and is often beyond the chance~     for cure at the time of the diagnosis. The lack of any treatment to substantially increase~     long term survival rates is reflected by the poor outcomes associated with this disease,~     specifically time to disease progression and overall survival.~      However, another important part of the body is now being looked at as a target for therapy~     against this disease - the immune system. Scientists have clearly shown that pancreatic~     tumor cells produce a number of defective proteins, or express normal proteins in highly~     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can~     cause an immune response to the cancer cells much in the way one responds to infected~     tissue. In progressive cancers however, the immune system fails to effectively identify or~     respond to these abnormalities and the cancer cells are not attacked or destroyed for~     reasons not yet fully understood. This clinical trial proposes a new way to stimulate the~     immune system to recognize pancreatic cancer cells and to stimulate an immune response that~     destroys or blocks the growth of the cancer.~      This new method of treatment helps the immune system of pancreatic cancer patients to~     identify the cancerous tissue so that it can be eliminated from the body. As an example,~     patients with certain diseases may require an organ transplant to replace a damaged kidney~     or heart. After receiving their transplant, these patients receive special drugs because~     they are at great danger of having an immune response that destroys or rejects the~     transplanted organ. This rejection occurs when their immune system responds to differences~     between the cells of the transplanted organ and their own immune system by attacking the~     foreign tissue in the same way as it would attack infected tissue. When the differences~     between foreign tissues and the patient's body are even larger, as with the differences~     between organs from different species, the rejection is very rapid, highly destructive, and~     the immunity it generates is longlasting. This is called hyperacute rejection and the~     medicine used to immunize patients in this protocol tries to harness this response to teach~     a patient's immune system to fight their pancreatic cancer just as the body would learn to~     reject a transplanted organ from an animal.~      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that~     contain a mouse gene that marks the cancer cells as foreign to patient's immune systems. The~     immune system therefore attacks these cancer cells just as they would attack any truly~     foreign tissue, destroying as much as it can. Additionally, the immune system is stimulated~     to identify differences (aside from the mouse gene) between these cancer cells and normal~     human tissue as foreign. This education of the immune system helps treat the patient~     because pancreatic cancer cells already present in a treated patient are believed to show~     some of the same differences from normal tissue as the modified pancreatic cancer cells in~     the product. Due to these similarities, the immune system, once educated by the~     Algenpantucel-L immunotherapy, identifies the patient's cancer as foreign and attacks.~      Historically, external beam radiation has been part of the treatment of pancreatic cancer,~     both before and after surgical resection. Recent breakthroughs in technology now allow for~     more intensive doses of radiation to be delivered to the body with greater precision. These~     newer, more precise radiation treatments, called stereotactic body radiation, deliver more~     intensive radiation to a locally advanced tumor and are now being employed in the treatment~     of pancreatic cancer. Stereotactic body radiation may increase the chances that surgery will~     successfully remove a pancreatic cancer.~      In this experimental study, all patients will be given a strong combination of antitumor~     chemotherapy while receiving injections of an immunotherapy drug consisting of two types of~     pancreatic cancer cells that have been modified to make them more easily recognized and~     attacked by the immune system. The investigators propose to test this new treatment paradigm~     along with stereotactic body radiation in patients with borderline resectable pancreatic~     cancer to demonstrate that treatment with this combination of therapies increases the time~     until the tumor progresses as well as overall survival.~   "
49776|NCT02405572|"~     Crossover study of 2 infant formulas~   "
49777|NCT02405559|"~     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In~     analogy with the arterial systolic pressure, the lymphatic pressure can give us information~     about the functioning of the cardiovascular system and fluid exchange. Actually, knowledge~     about this physiological parameter is incomplete because of the lack of technology. Former~     measurement techniques of the lymphatic pressure in the living healthy man were invasive and~     too complex to be interpreted.~      The lymphatic occlusion pressure has to be clarified because lymphedema treatment,~     concerning the pressure to be applied on the edematous tissue is still based on~     controversial concepts.~      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a~     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other~     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply~     relatively high pressure to obtain a decongesting effect. These completely opposite opinions~     triggered us to study lymphatic pressure more thoroughly.~      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since~     3 years by the promoters of this study to visualize the architecture of the superficial~     lymphatic network and the progression of the lymph inside the highlighted vessels. This~     technique will be used in the present (prospective and multicentric) study to observe the~     effect of a pressure applied on the lower limb on the displacement of the lymph, and then to~     determine the occlusion pressure of the lymphatic vessels. The investigators already studied~     the occlusion pressure of the superficial lymphatic vessels of the upper limb in a previous~     study. The investigators would like to complete our results with the lower limb.~   "
49778|NCT02405546|"~     A nasal endotracheal tube (ETT) is routinely placed in children and a fiberoptic scope (FOS)~     is commonly used for this purpose. Resistance to the passage of ETT is frequently~     encountered as it is advanced over the FOS for placement into the trachea, since it gets~     hung up on structures of the laryngeal inlet. The aim of the investigators study performed~     on forty children divided in two groups was to study in the pediatric population, whether a~     90° counterclockwise rotation (CCR) of the ETT prior to advancing through the larynx, by~     nasal approach, prevents it from getting hung up at the laryngeal inlet.~   "
49779|NCT02405533|"~     This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary~     outcome of this trial is achieving durable eradication persistent high risk HPV infection~     determined by HPV negative test results achieved while on active treatment with AHCC and~     maintained for 6 month post supplementation and 12 months post completion of AHCC treatment~     compared to placebo.~   "
49780|NCT02405520|"~     This phase I clinical study was designed to evaluate the safety and immunogenicity of the~     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech~     CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study~     volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo~     administered intramuscularly according to a 0-1-6 month schedule.~   "
49781|NCT02405507|"~     Wheat germ is a by-product of the wheat-milling industry with high nutritional value and~     therefore could be used as a raw source for the preparation of food products such as bread,~     cookies, muffins, etc.~      The aim of this study is to assess the effects of ingesting wheat breads supplemented with~     wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic~     response in healthy human volunteers.~   "
49782|NCT02405494|"~     Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective~     of this study is to test the individual contribution, and possible interaction, of the~     liquid volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x [gas~     volume/liquid volume]) of a beverage to its satiating properties.~   "
49783|NCT02405481|"~     The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado;~     Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to~     reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by~     community agency personnel. The study recruits Hispanic women between the ages of 18 and 50~     who are sexually active and are randomized to either SEPA or a Wait-List Control condition.~   "
49784|NCT02405468|"~     The investigators want to compare blood microbiota profile between patients with documented~     coronary lesions and patients free of coronary disease.~   "
49785|NCT02405455|"~     Cervical incompetence is a relatively complex disorder from the diagnostic and therapeutic~     point of view. Despite established diagnostic criteria, it is not easy for the specialist in~     clinical practice to establish limits in complicated cases. Cervical cerclage is the~     technique classically used to avoid pregnancy loss or preterm birth in patients with~     cervical incompetence. Although numerous studies support its efficacy, it remains a~     controversial method, given what the technique implies for the clinician and patient.~     Difficulties and potential risks of its insertion and inconveniences and side effects for~     the patient still exist. The recently published promising results of the use of the pessary~     to prevent preterm birth in women with a short cervix offer new prospectives for the~     management of prematurity prevention. The short learning curve, good cost-effectiveness and,~     most importantly, low side effects, render the pessary a tool of great potential.~   "
51975|NCT02376829|"~     To demonstrate that growing teenagers which present up to full cusp Class II malocclusions~     can be treated using the Invisalign System.~   "
49786|NCT02405442|"~     This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active~     Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by~     an Open Label Extension. Participants who complete the Blinded Treatment Period will be~     eligible to enroll in the optional Open Label Extension for an additional 44 weeks.~     Participants who complete Week 52 assessments will be eligible to enter the Extended~     Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.~   "
49787|NCT02405429|"~     The aim of this study was to evaluate the temporal artery thermometer by comparing temporal~     artery and axillary thermometer temperature measurements with rectal thermometer temperature~     measurements in neonatal patients. The investigators measured temporal artery, axillary, and~     rectal temperatures of 49 infants. Temporal artery temperature was measured using an~     infrared temporal artery thermometer, and the results with this device were compared with~     axillary temperature (clinical standard) and rectal temperature (gold standard). The~     difference between rectal and temporal artery temperatures was compared with the difference~     between rectal and axillary temperatures for each infant, and the data were analyzed based~     on weight, postmenstrual age and bed type - open crib or incubator.~   "
49788|NCT02405416|"~     This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with~     selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in~     complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another~     equivalent group patients will be operated using SHVE and PTC.~   "
49789|NCT02405403|"~     Neuroinflammation, characterized in particular by microglia activation, is an essential~     component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO)~     is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease~     activity. An experimental radiopharmaceutical specific of TSPO expression, namely~     [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography~     (PET) imaging.~      The purpose of this study is to longitudinally correlate the spatial distribution of~     neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in~     ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary~     approaches in 20 ALS patients:~        -  in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines~          secreted by microglial cells in the cerebrospinal fluid (CSF).~        -  in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of~          the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months~          latter.~   "
49790|NCT02405390|"~     The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will~     result in less head motion and therefore less cervical motion when compared with direct~     laryngoscopy (DL).~      The aim of the study is to determine the amount of head motion (extension, flexion and~     rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily,~     the study will also measure the number of attempts to properly intubate and the time~     required for intubation with either technique.~   "
49791|NCT02405377|"~     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive~     sufficient hydration before application of contrast to prevent CIN, but hydration could~     obviously increase the preload for congestive heart failure (CHF) patients. It is important~     to make an individual hydration protocol for patients with dysfunction of heart and renal to~     reduce the incidence rate of CIN. This prospective, randomized, double-blind, comparative~     clinical trial randomly selected 264 patients with estimated glomerular filtration rate,~     (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the~     convention hydration (n=132) or the central venous pressure (CVP) guided hydration (n=132).~   "
49792|NCT02405364|"~     The purpose is to determine whether induction and consolidation treatment with Carfilzomib,~     Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further~     investigation in clinical trials.~   "
49793|NCT02405351|"~     The investigators propose to develop a Telerehabilitation approach to working memory~     training for patients experiencing working memory deficits post stroke. The investigators~     have currently developed a game-like computerized working memory training program that can~     be accessed via the internet for research purposes. The investigators propose to refine the~     website to focus more on clinically based training, and to evaluate the feasibility and~     initial effectiveness of this approach in a pilot study with participants after stroke.~   "
49794|NCT02405338|"~     This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20~     patients including a safety-run in phase I part comprising 6 patients.~      Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs),~     presenting two leukemia-associated antigens.~   "
49795|NCT02405325|"~     Older adults are the least active population group in the US. Yet, research has shown that~     an increase in physical activity (PA) can have immediate and profound effects on~     cardiovascular health. Older adults who are active use significantly fewer health care~     resources, and with the increasing number of older adults in the US it is imperative to curb~     health care expenditure in this group. PEP4PA (Peer Empowerment Program 4 Physical Activity)~     is a multilevel intervention aimed at increasing physical activity levels in a population of~     low income and ethnically diverse older adults. It will be delivered in centers by trained~     older adults. Participants will work towards a daily increase of 2000 steps per day through~     self-paced incidental walking, peer led group walks, and attendance at existing center PA~     classes. They will also work on projects to increase opportunities to be physically active~     at their center or in the surrounding neighborhood.~   "
49822|NCT02404974|"~     The purpose of this pilot study is to assess the feasibility, acceptability, and potential~     effectiveness of identifying people with osteoarthritis (OA) who are interested in~     individualized exercise programs through a web-based osteoarthritis application; assessing~     their exercise barriers, facilitators, motivators and preferences; and engaging them in an~     exercise program tailored to meet their needs by a Certified Fitness Trainer.~   "
49837|NCT02404779|"~     Severely brain injured patients are at high risk of intracranial hypertension. Among medical~     treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but~     not english speaking societies.~      Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA~     versus placebo in the treatment of intracranial hypertension, and the underlying~     physiopathologic effects.~   "
49796|NCT02405312|"~     This year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will~     legitimately be raised as to whether terminal treatment and location of death adequately~     represented their preferences. These concerns are linked by a failure on the part of~     patients and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of~     hospice use among patients dying with ESRD is half that of the national average and~     one-quarter the rate for patients with terminal cancer. In other patient populations when~     meaningful EOL conversation occurs this is associated with increased hospice referral and~     improved quality of the dying.~      Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about~     prognoses, know little about availability of community hospice resources, or how to complete~     advance directives. Nephrologists are not trained to have these conversations, and although~     accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating~     with community hospices. Our preliminary research began by using focus groups, created and~     validated the first clinically useful HD prognostic tool, and developed a prototype for~     Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal~     intervention that familiarizes patients, families, and dialysis staff with community hospice~     resources, emphasizes dialysis social work support, conveys information about terminal care~     issues, and encourages advance care planning.~      The proposed study tests the central hypothesis that EOL care can be improved by relying on~     patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It~     will test whether an intervention that targets communication deficiencies can alter EOL~     outcomes and achieve the goal of matching patient preferences with terminal treatments.~   "
49797|NCT02405299|"~     This research aims to assess the cognitives rehabilitations in attention deficit disorder~     (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive~     factors for rehabilitative to improve the inhibition of disorders in ADHD.~   "
49798|NCT02405286|"~     This study aimed to Assess the validity of the Rockall score for the prediction of~     rebleeding and death in patients with upper gastrointestinal bleeding.~   "
49799|NCT02405273|"~     Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up~     to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most~     lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy~     for initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical~     candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces~     this number and patients undergo medical treatment or marginal lung resection, with minor~     functional impact but possible ineffective control of disease.~      Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer~     in-hospital stay, need for additional treatments, and a rise in sanitary costs.~      The investigators planned a randomised trial on surgical candidates to assess the effect of~     comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and~     Quality of Life (QoL).~   "
49800|NCT02405260|"~     This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active-~     controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of~     TTP399 on HbA1c following administration for 6 months.~   "
49801|NCT02405247|"~     The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients~     without the T790M mutation, both independently and when compared indirectly with NSCLC~     patients with the T790M mutation in the T STAR non interventional study (D5160R00001).~      The patient population in the TAURAS study will consist of patients who fail screening for~     AURA3 (D5160C00003) due to a T790M mutation not detected using the central cobas® EGFR~     Mutation Test (Roche Molecular Systems).~   "
49802|NCT02405234|"~     The proportion of patient successes with the Carbon Modular Radial Head at the 2-year~     evaluation is no lower than the proportion of patient successes with the Metal Radial Head.~   "
49803|NCT02405221|"~     This study will be looking at what dose of the TA-CIN/GPI-0100 vaccine is safe and effective~     in patients with a history of HPV16 associated cervical cancer.~   "
49804|NCT02405208|"~     This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded,~     prospective clinical outcomes investigation to evaluate the short, mid and long term~     performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.~   "
49805|NCT02405195|"~     Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary~     bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion,~     filtration and oxygenation.~   "
49806|NCT02405182|"~     Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative~     disorder. There is no treatment that significantly slows progression. Increasing age is an~     important risk factor for developing ALS; thus, the societal impact of this devastating~     disease will become more profound as the population ages. A significant hurdle to finding~     effective treatment has been an inability to accurately measure brain degeneration in~     humans. Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect,~     and may assist in aiding diagnosis and the efficient testing of new drugs.~      Different MRI features of brain degeneration will be measured in a large sample of patients~     with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC).~     CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical~     and neuroimaging protocols.~   "
49807|NCT02405169|"~     The primary objective of the present study is to evaluate the marginal bone level changes~     occurring in total edentulous patients treated with six or four implants.~      Secondary objective~        -  overall survival rate~        -  soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth~          (PPD) at baseline and after 1,3,5 years~        -  prosthetic survival rates including screw or abutment loosening, framework or veneer~          fractures~   "
49808|NCT02405156|"~     To compare the success rate of letrozole and misoprostol versus misoprostol alone for~     medical termination of pregnancy in second trimester abortion.~   "
49809|NCT02405143|"~     Occipital stroke is associated with homonymous visual field defects (occurring on one side~     of the visual field). Despite spontaneous recovery, some degree of defect is often~     permanent. Currently, no treatment exists for such visual field defects.The purpose of this~     study is to test the efficacy of a type of electrical brain stimulation method, transcranial~     alternating current stimulation, in reducing these type of visual field defects in their~     chronic stage.~   "
49835|NCT02404805|"~     The investigator believes simeprevir concentrations are unchanged when administered in~     combination with dolutegravir relative to administration alone. The investigator believes~     dolutegravir concentrations are unchanged when administered in combination with simeprevir.~     Additionally, the investigator believes simeprevir and dolutegravir are safe when~     administered alone and in combination.~   "
52282|NCT02372838|"~     This study assesses the long-term functional outcomes of upper extremity long bone defects~     treated with the free fibula bone transfer.~   "
49810|NCT02405130|"~     Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for~     treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to~     restore epicardial infarct-related artery patency and to achieve microvascular reperfusion~     as early as possible. No-reflow is the term used to describe inadequate myocardial perfusion~     of a given coronary segment without angiographic evidence of persistent mechanical~     obstruction of epicardial vessels and it refers to the high resistance of microvascular~     blood flow encountered during opening of the infarct-related coronary artery.~      Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of~     the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital~     and long-term prognosis. Several strategies have been tested to revert the no-reflow~     including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of~     intracoronary adenosine, but none has been demonstrated to effectively counteract the~     phenomenon.~      The trial aims to show the effect of the administration of intracoronary adrenalin on~     myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI~     and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI)~     0-1 flow during the interventional procedure after failure of standard therapy.~   "
49811|NCT02405117|"~     This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient~     self-management of bipolar disorder and facilitate more efficient, timely care delivery by~     mental health providers. The intervention uses a mobile application to collect daily~     self-report and continuous behavioral data and adapts intervention content to create a~     highly tailored and user-responsive treatment system. Patient data collected by the phone~     will also be provided to clinicians to allow for better evaluation and targeting of~     treatment. The goal is to reduce symptoms and prevent relapse in patients with bipolar~     disorder.~   "
49812|NCT02405104|"~     The purpose of this study is to elucidate whether patients operated with THA and TKA can~     benefit from treatment with chlorzoxazone.~   "
49813|NCT02405091|"~     Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered~     once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately~     150 medically stable male and female subjects with clinical diagnoses of schizophrenia or~     schizoaffective disorder with neuroleptic-induced TD or mood disorder with~     neuroleptic-induced TD.~   "
49814|NCT02405078|"~     The goal of this clinical research study is to learn if performing blood tests and imaging~     scans at different time points during chemotherapy can help researchers predict if patients~     with DLBCL will respond to treatment.~   "
49815|NCT02405065|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) and~     recommended phase 2 dose of HM95573.~   "
49816|NCT02405052|"~     Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable~     condition, is the most prevalent condition associated with unexplained chest pain in the~     emergency department. Panic-like anxiety may be responsible for a significant portion of the~     negative consequences of unexplained chest pain, such as functional limitations and~     chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the~     time of discharge from the emergency department. The 4-item Panic Screening Score~     questionnaire was derived in order to increase the identification of panic-like anxiety in~     emergency department patients with unexplained chest pain.~      The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2)~     validate the revised version of the Panic Screening Score; (3) measure the reliability of~     the revised version of the Panic Screening Score and (4) assess the acceptability of the~     instrument among emergency physicians.~   "
49817|NCT02405039|"~     This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL~     topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a~     one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be~     enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and~     Canada.~   "
49818|NCT02405026|"~     The purpose of this study is to determine the prevalence and severity of asthma in patients~     with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.~   "
49819|NCT02405013|"~     Primary Objective:~      To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment~     [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and~     weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in~     treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa~      Secondary Objectives:~        1. To estimate the study treatment SVR24 rate~        2. To evaluate the clinical and biological tolerance of study treatment~        3. To describe HCV kinetics under HCV treatment, and identify associated factors~        4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected~          patients~        5. To describe the changes of liver fibrosis based on non-invasive tests between treatment~          initiation, week 24, and week 36 after treatment, and estimate its association with~          SVR12 or SVR24~        6. To identify factors associated with SVR12 and SVR24 (including HIV status)~        7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and~          genotypying and for assessing response to treatment (SVR12 and SVR24)~        8. Facilitate the detection and treatment of those infected with HCV by supporting~          national initiatives for access to strategies without interferon~        9. To set up a HCV clinical research network across French and English-speaking African~          countries, able to run large-scale comparative randomized clinical trials in a near~          future.~   "
49820|NCT02405000|"~     The objective of this research is to perform a pilot study on patients undergoing~     laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer)~     in which intraoperative CT imaging will be performed both prior to (but after induction of~     general endotracheal anesthesia) and during placement of the laryngoscope in order to better~     understand anatomic changes that occur during instrumentation of the oral cavity and~     oropharynx. The goals of the study are:~        1. Develop a suite of de-identified images and surface renderings that qualitatively show~          how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic~          evaluation.~        2. Create deformation models of the upper aerodigestive tract.~      This data to be used for future retractor development as well as for virtual image guided~     surgery.~   "
57103|NCT02309671|"~     This trial investigates the effects of several doses of FE 999049 in Japanese women~     undergoing IVF/ICSI treatment.~   "
49823|NCT02404961|"~     The investigators plan to study the etiology of vulvodynia, a condition characterized by~     chronic vulvar discomfort, most often described as burning pain, occurring in the absence of~     relevant visible findings or a specific, clinically identifiable, neurologic disorder. Our~     hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response~     mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or~     psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as~     potential modifiers of the effects of interest. Therefore, the investigators propose to~     collect information about reproductive, gynecological and environmental exposures,~     psychological trauma and psychiatric morbidity, and biological markers of~     immuno-inflammation and nerve fiber proliferation.~   "
49824|NCT02404948|"~     This is a validation study comparing a pulse wave based algorithm for the detection of~     coronary artery disease with parameters from coronary angiography, echocardiography and~     cardiogoniometry.~   "
49825|NCT02404935|"~     National multicentric phase II trial evaluating whether single agent cetuximab is effective~     as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients~     with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after~     start of maintenance therapy.~   "
49826|NCT02404922|"~     This study will assess in healthy male and female subjects the safety, tolerability and~     pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days~     of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.~   "
49827|NCT02404909|"~     The aim of this study was to evaluate whether IVC index measured intraoperatively was~     affected by fluid administration and could add any helpful information about the~     hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC~     index was somehow correlated with the risk of postoperative complication.~   "
49828|NCT02404896|"~     Metreleptin was approved in the United States as adjunct to diet as replacement therapy to~     treat the complications of leptin deficiency in patients with congenital or acquired~     generalized lipodystrophy in February 2014. The approval was based on results obtained in 2~     open-label, investigator-sponsored studies (Studies 991265 and 20010769) conducted at the~     National Institutes of Health (NIH) to evaluate the safety and efficacy of metreleptin~     treatment in patients with lipodystrophy and 1 treatment IND (FHA101/MB002-002/MB002-002)~     conducted by Bristol-Myers Squibb on behalf of AstraZeneca (BMS/AZ) in patients with~     diabetes mellitus and/or hypertriglyceridemia related to lipodystrophy. These studies~     enrolled patients with lipodsytrophy including both generalized and partial lipodystrophy.~     Although the marketing authorization restricted the indication to patients with generalized~     lipodystrophy, meaningful clinical benefit was achieved in a subset of patients with partial~     lipodystrophy, and these patients from FHA101/MB002-002 form the basis of the request for~     ongoing treatment under expanded access.~   "
49829|NCT02404883|"~     Women who are diagnosed with cancer during their reproductive lifespan might be confronted~     with impaired fertility. Nowadays a number of fertility preservation options are available.~     Decisions about whether and how to protect fertility have to be made in a very short time~     period, right after cancer diagnosis and before start of treatment. The psychological impact~     for patients is considerable. This project aims at developing a standardized decision-aid~     tool to support the decision-making process about fertility preservation in young cancer~     patients. It is designed as an online decision-aid tool. A web-based tool is perfectly~     designed for this target group and offers new possibilities providing flexible and~     individually tailored information.~      The aim of the study is to examine the benefits of the online decision-aid tool compared~     with standard counseling (usual care). Decisional conflict is measured immediately after~     counseling as well as one month later. One year after counseling, decisional regret is being~     evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online~     design allows making it available for a wide range of concerned patients.~   "
49830|NCT02404870|"~     Background:~      - Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase~     the bone fracture risk in people with diabetes.~      Objective:~      - To see if Invokana has negative side effects on bone health.~      Eligibility:~      - Healthy men ages 18 45.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests. A~          nutritionist will discuss their dietary history and the study dietary requirements.~          Participants will get a food diary to record what they eat and drink on 3 separate~          days.~        -  Participants will have a DEXA scan x-ray test of bone health. Participants will lie~          still on a table while a small camera passes over the body.~        -  Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6~          overnights starting on a Sunday.~        -  Before each stay, participants will:~        -  Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks.~          They must eat only the food provided during these times.~        -  Collect their urine twice.~        -  During the stays, participants will:~        -  Be evaluated by a doctor and have blood drawn.~        -  On each Monday, participants will:~        -  Skip breakfast~        -  At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.~        -  Drink 6 ounces of water every 2 hours for 4 hours.~        -  An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2~          hours from 8 a.m. until noon.~        -  Get lunch.~        -  Have blood testing again at 8pm and midnight.~        -  Repeat the testing days 2 5.~        -  Have urine collected.~   "
49831|NCT02404857|"~     The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface)~     connected to a non-invasive pneumatic glove for rehabilitation of hand-movements~     post-stroke.~   "
49832|NCT02404844|"~     This is a clinical trial with a molecularly stratified parallel cohort, single arm design to~     explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with~     ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and~     different biomarker profiles, two of them potentially indicative of constitutive PI3K~     pathway activation.~   "
49833|NCT02404831|"~     The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation~     programme with traditional hospital-based pulmonary rehabilitation classes for people~     affected by COPD.~   "
49834|NCT02404818|"~     The purpose of this study is to evaluate if radiation and chemotherapy treatment cause~     cardiac abnormalities among survivors of Hodgkin's lymphoma.~   "
49838|NCT02404766|"~     C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated~     to cervical pain and headache. However, serious neurovascular adverse effects have been~     documented through direct treatment of C1-C2 segment. Although indirect treatment via~     adjacent segments and avoidance of end range of rotation and extension have been recommended~     for a safer and effective cervical treatment, there is no scientific evidence of the~     effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2~     hypomobility.~      Due to that, the investigators designed a randomized controlled trial to compare the~     short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of~     C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2~     hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the~     neutral cervical position can recover the C1-C2 rotational range of movement in subjects~     with upper cervical hypomobility.~   "
49839|NCT02404753|"~     The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2~     gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to~     determine whether LDG can be a test arm for a future Phase III trial to evaluate the~     non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant~     chemotherapy.~   "
49840|NCT02404740|"~     Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure~     (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus~     are typically treated with a shunt in order to reduce ICP. At times the shunt can~     malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's~     shunt has malfunctioned.~   "
49841|NCT02404727|"~     The aim of this project is to investigate prosthesis fixation in the bone, respectively~     cemented and uncemented operation method of Avantage® dual-mobility acetabular cup in~     elderly patients, wear of the plastic in dual-mobility hip prosthesis and evaluate the~     clinical function, patient satisfaction and possible complications.~      Patients included in this study suffer from osteoarthritis of the hip.~   "
49842|NCT02404714|"~     This is an observational comparative study to compare the standard-of-care methods for sweat~     testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat~     testing called the CF Quantum Sweat Test System. The results of the new device in this study~     are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's~     condition.~   "
49843|NCT02404701|"~     The purpose of this study is to ascertain whether certain supplements promote excessive~     urinary oxalate excretion and increase the risk for calcium oxalate kidney stones.~     Supplements that enhance urinary oxalate excretion, as a result of their oxalate~     concentration or from some other mechanism (e.g., providing substrate for oxalate~     biosynthesis) will be identified by the investigators.~   "
49844|NCT02404688|"~     The overarching goal of this study is to characterize the effects of ethanol and~     cannabinoids on simulated driving and related cognition.~   "
49845|NCT02404675|"~     This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in~     treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.~   "
49846|NCT02404662|"~     Most patients who present with problem drinking also present with mood problems. Problem~     drinking and mood problems co-occurring together in individuals lead them to have more~     severe symptoms, greater disability and poorer quality of life than individuals with only~     problem drinking, and they pose a greater economic burden to society due to their higher use~     of health services. This study aims to assess the efficacy of a new, innovative and cost~     effective treatment strategy aimed at reducing the burden that these co-occurring conditions~     impose on the suffers and their families as well as the community and health systems.~      In a recent pilot study of supportive text messages for patients with problem drinking and~     co-occurring depression, the investigators established that patients who received twice~     daily supportive text messages for three months had significantly less depressive symptoms~     than those who did not receive such messages. There was also a trend to finding that~     patients who received the supportive text messages were more likely to have higher alcohol~     free days than those who did not receive any supportive text messages.~      This study seeks to extend the knowledge gained from the pilot study. A larger group of~     patients with alcohol use disorder and a depressive disorder will be randomly assigned to~     two groups. One group will receive supportive text messages for six months duration whilst~     the other group will receive no supportive text messages. The patients will be followed up~     at 3, 6, 9 and 12 months to determine which of the two groups have less alcohol and mood~     problems. It is anticipated that patients receiving supportive text messages will report~     significantly greater alcohol free days as well as significantly less relapses,~     hospitalizations and mood symptoms than those not receiving such messages.~   "
49847|NCT02404649|"~     This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants~     (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will~     enroll 30 active subjects who will receive two dental implants in the edentulous maxillary~     molar region. This 24-month research study will examine the clinical stability of TMDI in~     both sinus elevation and sinus augmentation environments. The proposed research lays the~     foundation for improved health care by providing surgeons and restorative dentists with data~     for determining the effects TMDI have on clinical success in less than optimal osseous~     environments. The rationale that underlies the investigation is that identification of the~     influences of trabecular surface design on implant stability in varying bone types will~     allow routine, predictable use of early loading, which, in turn, will translate into more~     rapid, economical health care, and improved psychosocial well-being of the patient. If these~     hypotheses are correct, the results are expected to provide evidence based research data to~     support early loading and immediate loading of single implants in sites of adequate bone~     volume, and density with or without the use of graft materials in sinus lift procedures. In~     addition, it is expected that these results will fundamentally advance the field of implant~     dentistry and bioengineering by providing information on the principles of the bone~     density-mechanical environment-implant stability interaction.~   "
49868|NCT02404376|"~     Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before~     primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment~     elevation myocardial infarction), but the reduction is limited. This study investigates~     whether a combination therapy including both therapies is more effective.~   "
49848|NCT02404636|"~     ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview~     is used to quantitatively estimate:~        1. Alcohol use~        2. Dietary intake~        3. Drug use (legal and illegal)~      in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are~     followed up for 12 months with regard to response to therapy and survival.~      The study is intended to explore potential precipitants of alcoholic hepatitis.~   "
49849|NCT02404623|"~     This trial objective is to assess whether doubling the daily intake of vitamin D improves~     serum vitamin D levels and serves as primary prevention of respiratory infections and asthma~     in premature infants.~      This is a prospective randomized (1:1) double-blinded trial.~      The study population will be randomized into two groups (1:1):~        -  Intervention Group - 800 IU of Vitamin D once daily~        -  Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one~          year after randomization for serum Vitamin D levels and respiratory morbidity.~   "
49850|NCT02404610|"~     This study is a clinical trial of moderate sedation versus deep sedation with propofol for~     procedural sedation in the Emergency Department. The purpose of this study is to compare the~     rate of amnesia and respiratory depression rate in patients who receive moderate sedation to~     those that receive deep sedation.~   "
49851|NCT02404597|"~     The purpose of this study is to describe the use of non-invasive cardiac output monitors~     (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.~   "
49852|NCT02404584|"~     The primary objective of this study is to determine the percentage of patients with a plasma~     concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml~     (effective concentration according to the current literature).~   "
49853|NCT02404571|"~     This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and~     cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline~     treatment.~   "
49854|NCT02404558|"~     Primary Objective:~      To describe the safety and tolerability, including laboratory abnormalities following a~     single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in~     Japanese patients with rheumatoid arthritis (RA).~      Secondary Objectives:~      To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts,~     total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL]~     cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or~     tocilizumab administered SC as monotherapy in Japanese patients with RA.~      To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.~   "
49855|NCT02404545|"~     Total cystectomy (surgical removal of the bladder) is performed in a number of settings,~     including invasive bladder cancer and radiation cystitis. This requires a urinary diversion~     to be performed. The most common type of urinary diversion in this setting is an ileal~     conduit, where a section of small intestine is fashioned into a conduit that drains urine~     through a stoma into a pouch appliance, which is adhered at the level of the abdominal wall~     skin.~      There are multiple risk factors associated with the development of parastomal hernia after~     ileal conduit formation, including obesity, stoma site and size of the abdominal wall stoma~     opening.~      Up to 30% of patients with parastomal hernia will undergo surgical correction, mainly due to~     discomfort, urine leakage, skin excoriation, difficulty in maintaining a watertight ostomy~     appliance, increased frequency of ostomy pouch changes, or rarely due to bowel~     strangulation. Parastomal hernia repair is a challenging procedure which is not without~     significant risks. Furthermore, the outcomes of parastomal hernia repair surgery are highly~     variable.~      Prevention of parastomal hernia resulting from ileal conduit formation will help to decrease~     the incidence of hernia related complications, including pain, bowel complications, and~     urinary leakage due to poor stoma appliance. It will also decrease the significant cost~     associated with frequent stoma pouch changes. Prevention of parastomal hernia is expected to~     improve the quality of life of patients undergoing ileal conduit, and will reduce the need~     for secondary operations.~   "
49856|NCT02404532|"~     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System~     by completing a series of Patch applications and IEM ingestions in the clinic.~   "
49857|NCT02404519|"~     Vitamin K is required for the activation of the inhibitor of vascular calcification: Matrix~     Gla Protein (MGP). In an earlier study the beneficial effect of menaquinone-7 (MK-7), a~     vitamin K2 form, was observed on the stiffness of the vessel wall in postmenopausal women.~     It decreased the circulating form of inactive MGP and improved the vascular elasticity~     (local) and aortic pulse wave velocity (regional). The decrease of circulating inactive MGP~     was observed after 2-3 months MK-7 supplementation and the effect of MK-7 on the clinical~     endpoints was observed within 3 years of supplementation. It is demonstrated in several~     studies that cardiovascular risk increases with decreasing vitamin K intake and increasing~     levels of inactive MGP. In this study the investigators select subjects in the highest~     tertile of circulating inactive MGP. This study group will consist of subjects with~     increased cardiovascular risk and it is expected that effects of MK-7 on clinical endpoints~     in this group will be measurable within 1 year of supplementation.~   "
49869|NCT02404363|"~     Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine~     tumor.~      In a pilot study, the rate of microparticles was correlated with response rate of pancreatic~     adenocarcinoma.~      The aim of the study is;~        -  to compare the phenotypes of coagulation, the tumor progression and metastasis~          formation with and without clopidogrel treatment in association with chemotherapy in~          advanced pancreatic cancer patients~        -  to correlate the decrease of microparticles levels after one month of chemotherapy with~          tumor response (ancillary study)~   "
49870|NCT02404350|"~     The purpose of this study is to demonstrate efficacy including effect on inhibition of~     progression of structural damage, safety and tolerability up to 2 years with primary focus~     at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled~     syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in~     subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD~     therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years will be based on~     signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical~     function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well~     as skin and nail improvement for psoriasis signs.~   "
49858|NCT02404506|"~     Breast cancer is the most frequent malignancy in women, world-wide the leading cause of~     cancer mortality. One of the strongest risk factors for developing breast cancer is age,~     with a prevalence approaching 7% in women >70 years; more than 40% of breast cancer patients~     are older than 65 years. Although the survival rate has increased in the last years, about~     one third of patients will relapse with distant metastases. Treatment for patients with~     metastatic breast cancer is palliative, therefore maintaining or improving quality of life.~      The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic~     breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side~     effects, especially in elderly patients.~      Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the~     sea sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is~     registered as palliative chemotherapy in advanced breast cancer after anthracyclines and~     taxanes. Studies with eribulin treatment have shown similar efficacy compared to~     anthracyclines and taxanes, but less toxicity. Those studies showed that often the dose of~     eribulin had to be reduced during treatment due to toxicity without compromising the~     efficacy of the treatment.~      The main objective of the trial is to explore the efficacy of a reduced starting dose of~     eribulin as first-line treatment in elderly metastatic breast cancer patients. The secondary~     objective of the trial is to investigate the safety of eribulin in those patients.~      Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1~     and day 8 until progressive disease.~   "
49859|NCT02404493|"~     The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC)~     skin balm in infants and toddlers with mild to moderate dry, itchy skin.~   "
49860|NCT02404480|"~     This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in~     patients with advanced cancer.~   "
49861|NCT02404467|"~     The hypothesis behind this study is that there is a proportion of patients considered high~     or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged~     early after the procedure (within the first 2-3 days) without additional risks. Therefore,~     when performed in safety, an early discharge may cut periprocedural TAVI costs~     significantly.~   "
49862|NCT02404454|"~     The septate uterus is the most common structural uterine anomaly. It results from failure of~     the partition between the two fused Müllerian ducts to resorb;it is associated with the~     highest incidence of reproductive failure and with first- and second-trimester pregnancy~     loss and infertility.~      Hysteroscopic division of the uterine septum is performed using microscissors,~     electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome~     after hysteroscopic metroplasty.~      Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of~     autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine~     adhesions, through second look office hysteroscopy after three months.~   "
49863|NCT02404441|"~     The purpose of this first-in-human study of PDR001 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001~     administered i.v. as a single agent to adult patients with solid tumors.~      By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits~     the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by~     activating effector T-cells and inhibiting regulatory T-cells.~      This study has been designed as a phase I/II, multi-center, open-label study starting with a~     phase I dose escalation part followed by a phase II part.~      PDR001 will be administered every 2 weeks until patient experiences unacceptable toxicity,~     progressive disease per immune related Response Criteria (irRC) and/or treatment is~     discontinued at the discretion of the investigator or the patient.~   "
49864|NCT02404428|"~     Prostate cancer is a major public health problem and there is a strong need of new~     preventive strategies based on drug and lifestyle interventions. It is now well-established~     that healthy eating patterns and increasing physical activity can prevent or delay prostate~     cancer progression. Intake of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower,~     Brussels sprouts, kale) has been associated with decreased risk of prostate cancer~     progression; however the underlying biological mechanisms remain unknown. The investigators~     propose to undertake a pilot study on a group of men with early prostate cancer on active~     surveillance to determine whether a diet rich in broccoli will induce changes in tumor size~     and blood flow measured by conventional Magnetic Resonance Imaging (MRI) techniques. Men~     with early prostate cancer on active surveillance who have visible cancer lesions on MRI~     will be recruited onto this double-blinded randomized intervention and they will be asked to~     eat one portion of broccoli soup per week for 6 months. The investigators will test two~     varieties of broccoli (standard and 'Beneforte extra' broccoli) that are able to deliver two~     different levels of sulforaphane (SF), an active compound extensively studied for its~     potential anticancer properties. This study will involve MRI scans, blood and urine~     collection before and after a 6 month intervention period. This study design will not only~     allow us to observe diet-induced changes within the prostate but also at the systemic level.~     In addition, participant's lifestyle (habitual diet and physical activity) will be assessed~     by food diaries and exercise questionnaires.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
49865|NCT02404415|"~     The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and~     genetic biorepository that systematically enrolls patients undergoing atrial fibrillation~     (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation~     records with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical,~     genetic, and serological predictors of response to AF ablation in order to improve patient~     selection, and 2) to provide a resource for translational research investigating the~     electrophysiologic mechanisms of AF pathogenesis.~   "
49866|NCT02404402|"~     This study investigates the efficacy of a novel neuromodulation treatment, light emitting~     diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with~     traumatic brain injury (TBI).~   "
49867|NCT02404389|"~     This is a randomized, vehicle controlled, active comparator, parallel group, study with a~     total duration of 24 weeks including screening and follow-up. Study drug is applied~     topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of~     study endpoints are blinded to treatment allocation.~   "
74029|NCT02088372|"~     Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population~   "
49871|NCT02404337|"~     Oral treatment with betaine is conventionally used for patients with inherited~     homocystinurias.~      These conditions include a first group of patients with a cystathionine β-synthase (CBS)~     deficiency and a second group of patients with remethylation defects.~      The aim of betaine therapy is to reduce level of total plasma homocysteine. Daily dosages~     and rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d~     in 2 to 4 doses. These dosages are not based on validated data and several publications~     mention much higher dosages particularly when total homocysteine is not controlled. These~     practices may be unnecessary or even detrimental given the fact that high doses of betaine~     could for example lead to secondary folate deficiency.~   "
49872|NCT02404324|"~     The objective of this prospective study is the treatment of esotropia by prescribing the~     full precise optical correction of refractive errors in children up to 3 years old.~   "
49873|NCT02404311|"~     The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine~     combination. HIV is the virus that causes AIDS.~      About 252 people will take part in this study at multiple sites. The US National Institutes~     of Health (NIH) is paying for the study.~      The investigators are doing this study to answer several questions.~        -  Are the study vaccines safe to give to people?~        -  Are people able to take the study vaccines without becoming too uncomfortable?~        -  How do people's immune systems respond to the study vaccines? (Your immune system~          protects you from disease.)~   "
49874|NCT02404298|"~     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated~     disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy~     for CIDP. The investigators used a transcriptomic approach to compare the gene expression~     profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before~     and after IVIg treatment, in order to identify their mechanism of action in this condition,~     to lead to a better understanding of CIDP pathophysiology, and potentially determine factors~     associated with the response to the treatment.~   "
49875|NCT02404285|"~     This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild~     to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or~     vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes~     at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.~   "
49876|NCT02404272|"~     Poor oral motor development in preterm neonates is common. Feeding problems lead to longer~     hospital stay and higher hospital cost. Different interventions have shown their efficacy to~     accelerate transition and move faster to full oral feeding autonomy. Our study aimed to~     evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay~     of preterm neonates.~      This is an interrupted time series study placed in Intensive Care and Neonatal unit of an~     university hospital located in Lyon, France. All preterm neonates are included in the study,~     from April 2013 to January 2016.~   "
49877|NCT02404259|"~     This study will assess the pharmacokinetics of TDF in Thai HIV-infected children~   "
49878|NCT02404246|"~     This pilot effectiveness trial will evaluate the feasibility, acceptability, and~     effectiveness of a structured peer support program based on the Certified Peer Specialist~     Program of the Depression and Bipolar Support Alliance (DBSA).~   "
49879|NCT02404233|"~     Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside~     reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse~     transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral~     (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART),~     patients with HIV are living much longer. With the increasing lifespan of persons with HIV,~     long-term complications from therapy as well as the occurrence of co-morbidities with aging~     have prompted HCPs to re-think the current treatment paradigm and consider novel~     combinations of ARVs. All of the currently approved HIV antiretrovirals have been implicated~     in causing long-term toxicities; however the greatest body of evidence for long-term~     metabolic effects has implicated the nucleoside reverse transcriptase (NRTI) class. By~     utilizing a non-NRTI treatment regimen, it is hypothesized that many of these long-term~     metabolic effects (renal toxicity, bone loss, body fat changes) can be delayed or avoided~     altogether. The clinical data on novel combinations is currently limited but rapidly growing~     and has included several combinations that have utilized darunavir. This study will be the~     first of its kind using the unique combination of darunavir/cobicistat and rilpivirine.~     Currently, this drug combination is not a recommended option for first time treatment of HIV~   "
49880|NCT02404220|"~     This study will evaluate the safety, efficacy, tolerability, and pharmacokinetics of~     entospletinib (GS-9973) in combination with vincristine (VCR), and dexamethasone in adults~     with previously treated relapsed or refractory B-cell lineage acute lymphoid leukemia (ALL).~      This study consists of two parts: Dose Escalation and Dose Expansion. After 2 induction~     cycles during either parts of the study, participants may be put on maintenance for up to 36~     cycles if they have obtained clinical benefit from the treatment.~   "
49881|NCT02404207|"~     The study will determine the effects of different types of soybean oils on biomarkers of~     risk for cardiovascular disease and diabetes. There will be four 4-week diet periods in~     which participants will consume the following oils, within the context of a controlled diet:~     soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated~     soybean oil, and blend of palm olein & palm stearin.~   "
49889|NCT02404103|"~     The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved~     inhaled medication to treat asthma) affect the small airways in children with asthma.~   "
49890|NCT02404090|"~     Evaluation of the subchondral mineralization plate after excess weight loss in patientes~     undergoing bariatric operation by means of CT-osteoabsorptiometry.~   "
49891|NCT02404077|"~     The investigators' clinical practice makes use of oral clonidine as a means of transitioning~     from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days).~     Although this is common clinical practice, there is limited clinical data to demonstrate the~     efficacy of this technique and to provide clonidine dosing guidelines. The purpose of this~     study is to retrospectively review the investigators' experience with the use of oral~     clonidine to prevent withdrawal following the prolonged administration of dexmedetomidine.~   "
49960|NCT02403180|"~     The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D~     MF daily disposable contact lenses in an established presbyopic population.~   "
49882|NCT02404194|"~     This project is a randomized-controlled trial to test the efficacy of computer-based~     targeted cognitive training (TCT) versus a placebo intervention of commercial computer games~     in adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to~     optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim~     is to test the hypothesis that this neuroscience-guided TCT intervention will improve neural~     function, and that these neural improvements will improve cognition and functional outcome.~     CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games~     completed within 10 weeks. TCT consists of 20 hours of training in cognition, including~     processing speed, memory, attention, and cognitive control followed by 20 hours of training~     in social cognition including affect recognition and theory of mind. Neuroimaging,~     cognition, social cognition, clinical symptoms, and functional status will be assessed at~     baseline, after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20~     hours/5 weeks of social-cognitive training (post-intervention). Cognition, social cognition,~     symptoms, and functioning will also be assessed at a 9 month follow-up (i.e. 9 months after~     intervention completion). We predict that TCT will lead to improvements in neurocognitive~     function and functional status. The results of this study will provide important information~     about a benign, non-pharmacological intervention for improving cognition and functional~     outcome in CHR individuals.~   "
49883|NCT02404181|"~     Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized~     by physicians and nurses, even when screening instruments are used. Electroencephalography~     (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG~     recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG~     registration with three electrodes and automatic processing can distinguish patients with~     delirium from patients without delirium very well. However, these findings need to be~     validated in an unselected population.~      The primary objective of this validation study is to investigate the sensitivity,~     specificity, and predictive values of the EEG-based delirium monitor (including three~     electrodes and a reference electrode) compared to delirium quantification in frail elderly~     patients after surgery.~      In an international multicenter study, 154 frail elderly patients will be included who will~     undergo elective surgery and are expected to remain admitted for at least two postoperative~     days. Patients are excluded if communication is not possible or admitted for neurological~     surgery.~      A five minute EEG registration with the delirium monitor with four electrodes will be~     performed prior surgery and three consecutive days after surgery or until discharge. Within~     one hour of the EEG recording, the delirium assessment will be performed and recorded on~     video, which will be evaluated by delirium experts. The relative delta power (calculated~     from one minute of artifact-free EEG segment) will be compared with the conclusion of the~     delirium experts.~   "
49884|NCT02404168|"~     The prior BEEP study involved patients being switched between brand and generic in a very~     structured manner. Other secondary comparisons were also made (i.e. any differences in~     adverse effects and seizure control). Some subjects were more disparate than other, in terms~     of generic being similar to brand. In this follow up study, BEEP subjects that showed~     disparate results will be tested again to assess reproducibility of disparate results.~   "
49885|NCT02404155|"~     Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia~     (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed~     in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant~     SZ, especially for African-Americans (AA). Recent evidence suggests that low Absolute~     Neutrophil Counts (ANC), either at baseline or during treatment are a significant barrier to~     CLZ use in AA patients in the US, where guidelines mandate CLZ discontinuation if ANC drops~     below 1500 cells/mm3. The investigators group has found that discontinuation of CLZ in AA~     patients is over twice that in European-American (EA) patients (N~400; 42% vs.19%, P=0.041)~     and initiation rates are 50% lower. In a Statewide study (N=1875), the investigators~     reported that discontinuation was more frequently due to neutropenia in the AA sample,~     though no AA had developed agranulocytosis (8 cases in EA). Benign Ethnic Neutropenia (BEN)~     in people of African ancestry, including AAs, identifies a group (50% of AA) with low ANCs~     but no increased risk of agranulocytosis or infection. Low baseline or in-treatment~     fluctuations requiring CLZ discontinuation under current prescribing guidelines are common~     in CLZ-treated persons with BEN. In the investigators recent pilot study of N=12 AA patients~     with BEN, treatment was safely and successfully continued with CLZ despite low baseline ANC~     (outside current guidelines). Recent evidence implicates a polymorphism in the Duffy Antigen~     Receptor Chemokine (DARC) gene in the pathophysiology of BEN. In homozygotes (FY-/-) for the~     DARC null allele, mean within-subject neutrophil counts are reduced, resulting in sporadic~     ANC <1500 cells/mm3 in 10-15% of people with the allele. In population studies, the FY-/-~     genotype is found in 0.01% of EAs, 99.3% of sub-Saharan Africans (SSA), and 68% of AAs.~     Further, a missense DARC mutation has been reported to interact with the DARC FY-/- in~     determining low WBC in AAs. Normal patterns of week-to-week fluctuation in ANC levels in~     individuals of African ancestry with BEN and the DARC null genotype are not known, and no~     published research has examined variation in ANC in African ancestry CLZ-treated SZ patients~     with BEN and the DARC null genotype (FY-/-). Such data are also lacking on individuals with~     BEN without the DARC null genotype. Conducting such research will generate genetic marker~     and safety data that could be used to expand access to CLZ for AA patients who otherwise are~     eligible to receive this superior treatment option.~   "
49886|NCT02404142|"~     In this prospective, randomized study, the investigators assess the intubation conditions~     during videolaryngoscopy with Glidescope Titanium whether patients receive (curare~     (Atracurium) group) or no (control group) within elective surgery patients with no difficult~     intubation prediction~   "
49887|NCT02404129|"~     As the geriatric population continues to rise, the consequences of falls and fall-related~     injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more~     likely to result in hip fracture than a fall while walking straight. Hence, turning carries~     a significant risk for hip fracture. Turning is ubiquitous during activities of daily~     living, yet most gait research has focused on straight ahead walking.~      Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears~     to be a greater challenge for individuals with mobility problems. Turning ability is~     affected by age changes and balance confidence. TURN180 test was built to assess the~     parameters of turning. It has four major categories which are the most readily identified~     indictors of difficulty in turning while walking. These categories are: (1) the type of turn~     (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn,~     (3) the time taken to accomplish the turn, and (4) staggering during the turn.~      The purpose of this study is to explore the TURN180 test ability to evaluate the risk of~     falling in the elderly population and compare it to the known gold standard clinical test.~     This is a validation study of balance and mobility tests using a three-group sample of~     convenience. The independent elderly subjects (n=75) will be divided into three groups~     according to their falls history and undergo four balance tests: Timed Up and Go test~     (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be~     videotaped while performing the TUG test. Basic temporospatial aspects of turning during~     walking such as the number of steps taken during the turn and the time taken to accomplish~     the turn will be measured using both the slow-motion and stop-action capabilities of the VCR~     system and a time-code processor.~   "
49888|NCT02404116|"~     The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT)~     which has shown promising results in the treatment of health anxiety to no treatment at all-~     a waiting list.~   "
82052|NCT01983488|"~     This study is aimed at investigating the long term clinical outcome of patients with~     uveitis.~   "
49892|NCT02404064|"~     To compare surgical site infection (SSI) rate in patients undergoing laparoscopic~     appendectomy for acute uncomplicated appendicitis and treated with single dose regime of~     antibiotics versus group of patients undergoing laparoscopic appendectomy without~     antibiotics treatment. Patient will be given either single dose of perioperative antibiotics~     or no antibiotics before surgery.~   "
49893|NCT02404051|"~     This is a multi-center, randomized, open-label, parallel group study designed to evaluate~     efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus~     versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal~     women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or~     metastatic setting.~   "
49894|NCT02404038|"~     This study will enrol sexually active, healthy girls aged 16-17 to assess and compare the~     acceptability and preference for a monthly vaginal ring, bi-monthly injectable contraception~     or daily dose oral contraception, as proxy for female-controlled ARV-based HIV prevention~     methods.~   "
49895|NCT02404025|"~     This is an open label, non-randomized, phase II study of eltrombopag in combination with~     rabbit ATG/CsA in subjects with moderate or more severe AA who have not received prior~     ATG/ALG-based immunosuppressive therapy. The objective is to assess additive effects of~     eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA.~     Subjects will be assessed at least weekly for safety during the period from the start of~     ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects~     will visit every 2 weeks until Week 26. Subjects in whom the treatment is assessed as~     effective at Week 26 may continue treatment with eltrombopag after 6 months when clinically~     indicated at the discretion of the investigator. There are five follow-up visits: at~     discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment~     discontinuation. As this study is the first Japanese phase II study in which this product is~     administered in combination with ATG/CsA to subjects with naive moderate or more severe AA,~     the subject number of this study is determined to be 10 based on the feasibility survey.~   "
49896|NCT02404012|"~     There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and~     effective therapies are lacking. Thus, there is a critical need for an effective,~     non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and~     improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric~     surgery patient population. Often, patients do not participate in bariatric programs, are~     not compliant, and/or are lost to follow-up. If there is a more effective and evidence-based~     guideline for repletion of iron deficiency, patients are more likely to be compliant.~     Therefore, in a randomized controlled study, the investigators propose to test the~     effectiveness of HIP versus ferrous sulfate for oral iron supplementation of iron deficient~     patients who have had RYGB or SG bariatric surgery. By randomizing patients into the two~     groups, the investigators will be able to determine the most effective regimen to improve~     blood biomarkers of iron status, cognitive function, and quality of life. Other outcomes~     will include adverse effects and compliance to the supplementation. The investigators will~     also analyze three-day food records to determine the contribution of dietary factors to~     changes in iron status. To test for improvement of iron status, serial blood draws will be~     performed during a time period of ~10 weeks. Serial blood draws from iron deficient patients~     have routinely been performed in past studies and have not been found to be harmful. Because~     this is a relatively short study (10 weeks), subjects will be able to recover quickly from~     the blood loss during the study. the investigators expect to find that iron supplementation~     with HIP will be more effective than ferrous sulfate for repletion of iron deficiency. This~     project will address a significant health issue in individuals who have had bariatric~     surgery, which is a growing population in the United States. It is estimated that almost 1.5~     million individuals have undergone bariatric surgery since the year 1990.~   "
49897|NCT02403999|"~     This will be a single centre, evaluator blind, randomized, parallel group, stratified, two~     week study in healthy participants. The clinical study is designed to provide reassurance~     that the formulations developed for children and babies with mild to moderately dry skin and~     for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the~     target population, babies and young children with dry skin.~   "
49898|NCT02403986|"~     A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and~     three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.~      Approximately 50 female subjects shall be treated with two or three initial treatment~     sessions including long-term follow-up 18 months after the initial treatment regimen.~   "
49899|NCT02403973|"~     To explore the possible benefit of a patient hotel, a study was undertaken to test the~     hypothesis that perioperative care at a patient hotel would be valued better than care in a~     general ward. The study focuses solely on the patients' perspective and satisfaction of the~     care provided.~   "
49900|NCT02403960|"~     Aim: to evaluate the additional effects of the 12 weeks usage of a Streptococcus containing~     probiotic tablet after scaling and rootplaning compared to a placebo tablet.~      Materials and methods: 48 periodontitis patients were included in this double-blind,~     placebo-controlled trial. After scaling and rootplaning, they were given patients used~     either a placebo (SRP) or probiotic tablet (SRP + P), 2 times a day for 12 weeks. Clinical~     and microbiological parameters were studied recorded up to 24 weeks after scaling and~     rootplaning.~   "
49901|NCT02403947|"~     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system~     (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and~     multifactorial, but the key pathogenic event appears to be an uncontrolled response of~     components of the immune system (T and B lymphocytes) to myelin proteins. No definitive~     treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as~     disease-modifying agents (DMDs).~      Unfortunately, the current treatments demonstrate partial efficacy in targeting the~     deleterious immune reactions. According to the present knowledge of the pathophysiology of~     MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune~     process, to protect axons and neurons from degeneration, and to enhance repair and~     facilitate remyelination.~      A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown~     remarkable ability to modulate the immune response. This study will evaluate the safety of~     injecting MSCs in people with MS.~   "
49928|NCT02403596|"~     This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood~     loss using two dosage regimens (standard and extended) after a surgery during total hip~     arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for~     prophylaxis of thrombosis.~   "
49929|NCT02403583|"~     The purpose of the study is to develop and pilot-test a home-based intervention to~     facilitate sate HIV testing and disclosure within pregnant couples in order to increase use~     of prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya.~   "
49981|NCT02402985|"~     This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes~     investigates the nutrition influence of animal protein in comparison to plant protein on the~     glucose metabolism.~   "
82088|NCT01982929|"~     Patients at Mbarara Regional Referral Hospital (MRRH) in Uganda who present for routine~     caesarean sections often go without a set post-operative pain control regimen. Due to lack~     of established protocols and supplies of essential pain control medications are not~     reliable, upwards of 90% of women receive no postoperative pain control. There are regional~     techniques that are effective, easy to perform, low risk, and inexpensive. One of these~     techniques is a tranversus abdominis plane (TAP) block.~      A TAP block is a regional anesthesia technique that provides analgesia to the parietal~     peritoneum as well as the skin and muscles of the anterior abdominal wall [1, 3-7]. First~     described just over a decade ago, it has undergone modifications in technique, and has been~     shown to be useful in providing 12-24 hours of significant post-operative pain relief for a~     wide array of surgical procedures [2]. It is best used as the cornerstone of a multi-modal~     approach to pain control and combines well with oral and intravenous opioid and non-opioid~     medications.~      This is a technically straightforward procedure that involves injection of local anesthetic~     within the fascial plane located between the two deepest muscle layers (transversus~     abdominis and internal oblique muscles) of the lower abdominal wall. Given the simplicity of~     the TAP block and its long-lasting diminution in post-operative pain after many abdominal~     and pelvic surgeries, the incorporation of TAP blocks into post- caesarean section pain~     management should be considered as an achievable and simple remedy to the lack of reliable~     pain mediations after surgical delivery at MRRH.~      This is a study that examines the efficacy of tranversus abdominis plane (TAP) blocks in~     providing post-operative analgesia after caesarean section under spinal anesthesia at~     Mbarara Regional Referral Hospital (MRRH) in Uganda, Africa. We will look at the value of~     TAP blocks in supplementing a routinely used (when available) post-operative non-opioid oral~     analgesic regimen.~      Primary Hypothesis:~      The administration of a TAP block on completion of caesarean section will decrease the level~     of pain as measured by a visual Numerical Rating Score (NRS) at 8, 16 and 24 hours, both at~     rest and with movement.~      Secondary Hypotheses:~        1. The administration of a TAP block on completion of caesarean section will increase the~          satisfaction score at 8, 16, and 24 hours; and~        2. The administration of a TAP block will decrease or prevent the need for postoperative~          nurse- administered pethidine (meperidine) as a rescue medication.~      This is a prospective, randomized, double-blind, sham controlled, single-center trial. A~     total of 240 patients will be enrolled in the study.~      Following completion of the caesarean section, all patient will be screened for enrollment~     into the study. Enrollees will be randomly assigned to an arm via a predetermined~     undisclosed random number generator that will not be known by the staff at the MRRH. The~     anesthesiologist performing the TAP or sham block will be given a sealed envelope with the~     study arm which the patient has been randomized.~      The study procedure is a TAP block and it will be placed on 50% of the enrollees.~      TAP BLOCK:~      Physicians who have been fully trained on the performance and potential risks of the~     technique will place TAP blocks under ultrasound-guidance. Briefly, under sterile~     conditions, ultrasound will be used to identify the targeted abdominal fascial plane. Once~     located, a predetermined amount of local anesthetic will be injected. This will be~     performed, bilaterally. The patient will be monitored during the block and for 30 minutes to~     follow.~      SHAM BLOCK:~      Sham blocks will consist of a non-invasive ultrasound scan over the abdomen. To mimic the~     injection of medicine, a dull/blunt object will be gently pressed on either side of the~     abdomen. The patient will be monitored during the sham block and for 30 minutes to follow.~   "
49902|NCT02403934|"~     Maintaining a patent airway is a constant concern to any anesthesia provider performing deep~     sedation cases. The doses of sedative medications often required for the desired level of~     sedation in a patient often result in occlusion of the airway and the patient becoming~     apneic. Opening the collapsed or occluded airway requires the use of an invasive airway~     device, (e.g. laryngeal mask airway (LMA), oral airway or nasal airway) or the application~     of a jaw thrust maneuver. When the provider provides jaw thrust while attending to the other~     duties, the patient may not have adequate ventilation and the patient's oxygen saturation~     can fall producing hypoxemia. Airway management devices currently available require deeper~     levels of sedation to be tolerated by patients. In order to avoid the need for internal~     airway devices, providers attempt to carefully adjust the level of sedation so that no~     airway support is required. For safety, providers usually try to stay on the light side of~     the sedation scale. Unfortunately, this often results in an uncomfortable patient or one who~     is moving too much to successfully carry out the procedure. Until the availability of the~     Jaw Elevation Device (JED) there was no external device providers could utilize to assist in~     opening a patient's airway. By duplicating the jaw thrust maneuver, the JED maintains a~     patent airway. Once applied, it frees the anesthesia provider to attend to other duties~     associated with administration of anesthesia without requiring the provider to manually~     maintain a jaw thrust maneuver. The advantages with such a device would allow a level of~     sedation deep enough for the patient to tolerate the procedure as well as maintain a patent~     airway. To date, there have not been any studies evaluating the JED in clinical practice.~     The investigators wish to evaluate the JED in a standardized fashion during deep sedation or~     monitored anesthesia care (MAC). Our study would involve 50 patients who became apneic~     during deep sedation or MAC. A jaw thrust maneuver will be initially performed to~     demonstrate that each patient's airway can be adequately supported by this maneuver. The JED~     will then be placed in order to maintain a patent airway, while leaving the level of~     sedation unchanged. Intraoperative monitoring, continuous ECG, pulse oximetry, blood~     pressure, capnography, will be routine, and determined by the anesthesia team. The~     investigators will also track how often the provider was required to adjust the JED to~     maintain a patent airway, and if the need to convert to an alternate method of airway~     management was required. The investigators will pursue publication of the results as the~     first study demonstrating the efficacy of the JED.~   "
49903|NCT02403921|"~     The investigators aim to investigate the association between hair, serum, urine and saliva~     to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.~   "
49904|NCT02403908|"~     The aim of research proposal is to assess and compare the safety and efficacy of~     radiofrequency denervation of pulmonary arteries on decrease in pulmonary vascular~     resistance and mean pulmonary artery pressure (MPAP) in 20 patients with IPAH (mean~     pulmonary artery pressure >25 mmHg) and in 20 patients with secondary pulmonary hypertension~     due to pulmonary disease or due to left heart disease not responding optimally to medical~     therapy.~   "
49905|NCT02403895|"~     Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of~     AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)~   "
49906|NCT02403882|"~     The investigators run a series of behavioral economic interventions at client-choice food~     pantries to encourage clients to choose targeted foods.~   "
49907|NCT02403869|"~     Post-authorization, prospective follow-up, multi-centre, national study to estimate~     definitive deterioration in the quality of life in patients with metastatic breast cancer~     treated with second-line monochemotherapy.~   "
49908|NCT02403856|"~     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.~     Needling and lavage of the calcification is one of the therapeutic options after failure of~     conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually~     followed by a corticosteroid injection in the subacromial bursae in order to prevent acute~     pain reaction due to the intervention. However, the relevance of this injection has never~     been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the~     needling and thus the body's natural calcium resorption processes. Finally, corticosteroids~     could have deleterious effect on the tendon structures and favour local infection. Our~     hypothesis is that corticosteroid have no significant effect on acute pain after needling~     and therefore should not been performed systematically after needling.~   "
49909|NCT02403843|"~     The purpose of the study is to follow patients with partial onset seizures prospectively~     over 5 years in the real-world environment to gather data on the long-term safety and~     effectiveness of the RNS System at qualified CECs by qualified neurologists,~     epileptologists, and neurosurgeons trained on the RNS System.~   "
49910|NCT02403830|"~     Ticagrelor is associated with more prompt and potent antiplatelet effects compared with~     clopidogrel, leading to better clinical outcomes, including reduced cardiovascular~     mortality, across the spectrum of patients with acute coronary syndrome, including those~     with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary~     intervention (PCI). However, in this latter setting a delay in the onset of its antiplatelet~     effects has been shown. Morphine has been identified as a cause of delayed P2Y12 inhibition~     in patients with STEMI. Methylnaltrexone is a parenteral peripheral opioid receptor~     antagonist which has the potential to prevent or reverse opioid-induced peripherally~     mediated side effects without affecting analgesia. However, whether the use of intravenous~     methylnaltrexone may overcome the effects of morphine administration on the pharmacokinetic~     (PK) and pharmacodynamics (PD) profiles of ticagrelor has not been investigated yet. The~     proposed investigation will include patients with coronary artery disease and will have a~     prospective, randomized, cross-over design.~   "
49911|NCT02403817|"~     Current therapies for autism target social and language behaviors, but due to the high-level~     nature of these skills any improvement rarely extends beyond the targeted behavior. This~     project uses new technology to implement a novel concept for behavioral intervention to~     improve basic attention and eye movement skills in ASD. Because these basic skills form the~     foundation for good social communication, training these abilities has the potential to~     improve a broad spectrum of clinical symptoms, and in young children may affect the course~     of development.~   "
49912|NCT02403804|"~     The goal is to assess whether, in adult women during the luteal phase of their menstrual~     cycle, supplementing their diet with either phosphatidylcholine or betaine increases their~     serum choline levels.~   "
49913|NCT02403791|"~     The purpose of this study was to evaluate the availability and diagnostic accuracy of~     point-of-care bedside lung ultrasound examination in management of mechanical ventilation in~     neonatal acute respiratory distress syndrome.~   "
49914|NCT02403778|"~     The purpose of this study is to assess the safety and efficacy of combined treatment with~     Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.~   "
49915|NCT02403765|"~     The study aims to identify genetic variants associated to Parkinson's disease through the~     analysis of exome-sequencing data of familial cases and controls. The identified variants~     will be used to generate a diagnostic tool for the identification of genetic risk profiles.~   "
49930|NCT02403570|"~     The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols~     suitable for patients with multiple sclerosis using advanced MRI such as rotating frame~     relaxation imaging. In addition, the investigators want to study the correlation between~     advanced MRI parameters and clinical disease progression.~   "
49916|NCT02403752|"~     Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for~     ambulatory individuals with dementia and caregivers living at home based on recruitment,~     adherence and retention. Investigators will conduct a pilot randomized controlled trial~     (RCT) with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise~     classes and regular home practice or wait list in a cross-over design. Investigators will~     assess feasibility of enrollment and retention, the proportion of completed outcome~     measures, and adherence by class attendance logs, caregiver-reported home practice logs and~     qualitative interviews to assess ease of implementation in the home environment.~     Investigators will explore feasibility of weekly phone calls to (potentially overwhelmed)~     caregivers and Fit-bit accelerometers as a measure for tracking home practice.~      Specific Aim 2: To collect preliminary effect size data for sample size calculation for a~     larger trial. Investigators will assess standard outcomes (such as the Short Physical~     Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary~     outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly~     used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks~     and calculate effect sizes (Cohen's d) for between-group differences in outcome changes in~     the 20 dyads of the RCT described in Specific Aim 1.~      Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy~     (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change.~     Investigators will compare brain oxygenation variations before and after the exercise~     intervention during a memory task for the seniors with dementia.~   "
49917|NCT02403739|"~     Simulated growth data will be shown to clinicians in two formats - (1) as weight vs.age~     charts, (2) as weight Z-score vs. age charts. Clinicians will be asked to identify whether~     growth is too fast, too slow, or normal. The test will take a total of 10 minutes.~   "
49918|NCT02403726|"~     The purposes of this study were to analyse demographic, medical, gender and socio-economic~     aspects of osteoporosis associated vertebral fractures.~   "
49919|NCT02403713|"~     A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a~     pressurised metered dose inhaler (pMDI) with and without spacer.~   "
49920|NCT02403700|"~     Bone modeling after tooth extraction has a major consequence on implant therapy, in~     particular in the esthetic zone. In esthetic sites, no tissue loss should occur if an~     optimal esthetic outcome is expected. Recent experimental studies in dogs have shown that~     neither an immediate implant insertion nor ridge preservation techniques can prevent this~     bone modeling process.~   "
49921|NCT02403687|"~     A 24-week observational prospective study on the efficacy of topical non-steroidal~     anti-inflammatory drugs for the relief of pain.~   "
49922|NCT02403674|"~     The purpose of this study is to compare the antiretroviral activity of MK-1439A, a~     single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg +~     lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC~     containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg,~     in treatment-naive participants infected with HIV. The primary hypothesis is that MK-1439A~     q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with~     HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48.~   "
49923|NCT02403661|"~     The primary goal of this study is to quantify the functional deficits caused by injuries to~     the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible~     benefit of electrical stimulation of the injured nerve following surgery. The investigators~     will test whether electrical stimulation will improve hand function and nerve regeneration~     after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common.~     In severe cases, functional outcomes even with surgery remain poor. Recently, electrical~     stimulation has been applied to injured nerves in rats. This was shown to improve nerve~     regeneration. These studies showed that as little as one hour of electrical stimulation was~     effective. Therefore, the investigators plan to test this new method of treatment to~     determine whether it is also helpful in humans. These will be done by using a symptom~     severity questionnaire, nerve conduction studies and by testing pressure sensations, hand~     dexterity and strength. The patients will be randomized to either the treatment or control~     group. Following the treatment, all baseline measurements will be reevaluated every three~     months for the first year and every 6 months during the second year. The timing and nature~     of the evaluation process will be identical in both groups.~   "
49924|NCT02403648|"~     BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes~     (reconstitutes) the powder with liquid to make it easier for users to treat patients with~     severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into~     the bloodstream, how much it raises glucose concentrations (the intended effect) and compare~     to two glucagon products already on the market.~   "
49925|NCT02403635|"~     CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo~     the induction effect of ASP2151 on that enzyme to determine the extent of any possible drug~     interactions. The aim of this trial is to investigate the potential for interaction of~     ASP2151 with the CYP3A4 probe substrate midazolam.~   "
49926|NCT02403622|"~     The overarching objective of this study is to address the knowledge gap regarding the~     short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a~     prospective, open-label, multi-center longitudinal cohort study to assess the short- and~     long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients~     with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools~     over 24 hours for 2 consecutive days and either a positive stool test for CDI or~     pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred~     to one of the study centers after at least three recurrent episodes of CDI and previous~     treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by~     colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored~     for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical~     assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT.~     Subjects who recur will be offered a second FMT by colonoscopy with a different donor.~     Microbiome analysis will be conducted from stool samples at baseline and each of the 5~     follow-up intervals.~   "
49927|NCT02403609|"~     The purpose of this study is to evaluate test-retest reliability of each subtest~     (correlation coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs,~     Inc.).~   "
49933|NCT02403531|"~     The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown.~     The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy~     followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with~     inoperable thoracic esophageal squamous cell carcinoma.~   "
49934|NCT02403518|"~     This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of~     chronic back and leg pain. Patients who have been diagnosed with failed back surgery~     syndrome (FBSS) will receive a stimulator device for treatment of their pain.~   "
49935|NCT02403505|"~     That current oncology drugs on USA market have the universal problems about low~     effectiveness of pharmacology to cancer cells and high risk of toxicology to normal cells~     can demonstrate following most significantly and most reasonably: it is not enough so far~     that just only oncology drug targets directly like as cancer patient-specific biomarkers; it~     must be that oncology drug targets' SNPs via patient-specific haplotype blocks like as real~     personalized or individualized cancer patient-specific biomarkers.~   "
49936|NCT02403492|"~     Heart disease is a major cause of ill-health and death in adults. The risk factors for heart~     disease, if present in children, carry over into adult life. Childhood obesity has reached~     epidemic proportions in Canada and is associated with many heart disease risk factors such~     as high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep~     apnea is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in~     up to 60% of obese children, but it is diagnosed in less than 20% of obese children.~     Importantly, sleep apnea in children, like obesity, is linked with high blood pressure and~     heart disease. Thus, children with sleep apnea who are obese are likely to have an increased~     risk for high blood pressure and heart disease. Currently, there is little knowledge of the~     extent of heart disease in obese children with sleep apnea.~      The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies~     are generally not very successful and since 75% of obese children will become obese adults,~     urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea~     in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated~     with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a~     breathing machine while asleep. It is unknown how effective CPAP is in reducing heart~     disease in obese children.~      The investigators will recruit children with sleep apnea who are obese and test for heart~     disease risk. The investigators will then treat these children with CPAP. After 6 months of~     CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart~     disease. At the end of the 6 months, those receiving CPAP will be randomized to either~     continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the~     participants will repeat the tests again to determine the magnitude of the effect of CPAP.~      The investigators expect that CPAP treatment for sleep apnea in obese children will reduce~     blood pressure and lower heart disease. These results will increase awareness of the dangers~     of sleep apnea in obese children, which will facilitate early diagnosis and treatment,~     ultimately reducing heart disease long-term.~   "
49937|NCT02403479|"~     Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when~     the lining of the sinuses becomes persistently irritated. Standard management options~     include topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is~     frequently encountered. Bacterial biofilms are routinely detected within the nasal mucosa of~     CRSsP patients and are now thought to play an important role in the protracted nature of the~     disease. Colloidal silver is a widely used naturopathic agent that has recently been shown~     to eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies.~     Although silver is currently used in a variety of chronic wound therapies, it has not yet~     been formally studied in people with CRSsP. It is our intention with this project to~     determine whether colloidal silver is a useful treatment strategy for patients with~     refractory CRS.~   "
49938|NCT02403466|"~     Because communication and handoff failures are a root cause of two-thirds of sentinel~     events- serious, often fatal preventable adverse events in hospitals improving handoffs has~     been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to~     improve patient safety. Comparative Effectiveness Research on handoff tools and processes~     has identified specific strategies to improve handoffs and reduce medical errors: 1) team~     training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal~     sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient~     safety, the investigators are implementing the three inventions above as a Resident Handoff~     Bundle (RHB) in eight pediatric hospitals in the United States and Canada.~   "
49939|NCT02403453|"~     A Prospective, open label, multi-center observational study of patients requiring surgical~     treatment at one or two (contiguous) cervical spine levels. The primary objectives of the~     RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments~     and surgical technique; confirm device performance in terms of clinical and radiographic~     outcomes; confirm device performance in terms of safety and to collect original data to be~     compared to published reports of the performance of comparable motion-sparing devices, as~     well as clinical outcomes of fusion devices.~   "
49940|NCT02403440|"~     The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics~     (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.~   "
49941|NCT02403427|"~     The purpose of this study to conduct the preliminary investigation on the efficacy and~     safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert~     VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump~     therapy.~   "
49942|NCT02403414|"~     Acromegaly is associated with increased risk of difficult intubation and its management. The~     overall incidence of difficult intubation in patients suffering from acromegaly is four to~     five times more than those without acromegaly.The difficult intubation scenario in these~     patients can be managed by various methods ranging from awake fiberoptic intubation to~     tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries~     and results in significant morbidity and mortality in general population. In patients with~     acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia~     related deaths. Therefore, the need and importance of airway assessment in patients with~     acromegaly cannot be overemphasized. Various tests of airway assessment have to be used to~     assess difficult airway and tracheal intubation in acromegalics.~      The investigators aim to assess the various tests of airway assessment affecting the outcome~     of patients with acromegaly undergoing pituitary surgery and identify which was best suited.~   "
49943|NCT02403401|"~     Purpose of the study is to investigate safety and contraceptive efficacy of an~     LNG-containing intravaginal ring.~   "
49982|NCT02402972|"~     To investigate whether intraoperative intraportal chemotherapy combined with adjuvant~     chemotherapy as treatment could improve disease-free survival (DFS) in patients with~     curative colorectal cancer resection compared with adjuvant chemotherapy alone.~      This is a prospective, blind (doctors who done outcome measures were masked), multi-center,~     2-arm randomized controlled trial.~   "
50089|NCT02401464|"~     The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2~     different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536~     commercial tablet in healthy Japanese adult male participants.~   "
49944|NCT02403388|"~     Avoidable care associated incidents are relatively frequent in primary care. In France for~     example, avoidable incidents rate is estimated to 22/1000 medical acts from general~     practitioners. Patient safety is now a growing issue in primary care. One tool to increase~     patient safety is incident reporting and analysis. It could reduce some important~     consequences for patients and could allow implementing substantial corrective actions.~      The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk~     management program implemented in the french pluridisciplinary offices in primary care in~     association with a centralized incident reporting system, versus a centralized incident~     reporting system only.~   "
49945|NCT02403375|"~     This study is to compare metabolic control, treatment satisfaction, and quality of life~     during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump~     system with multiple daily injections (MDI) therapy. Furthermore, this study will add~     clinical data originating from clinical investigation in a special population, i.e. children~     and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK~     Insight insulin pump.~   "
49946|NCT02403362|"~     The purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic~     kidney disease (CKD) Who are not on dialysis~   "
49947|NCT02403349|"~     Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and~     compare correlation with the measured peripheral (central blood pressure, pulse wave~     velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler~     findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.~   "
49948|NCT02403336|"~     Objective: To evaluate the efficiency of a grupal intervention opposite to the usual care to~     improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55~     years to the primary health care centres.~   "
49949|NCT02403323|"~     This two-part, open-label extension and safety monitoring study will examine the safety and~     efficacy of continued etrolizumab treatment in patients with moderate to severely active~     Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.~   "
49950|NCT02403310|"~     The main purpose of this study is to determine the safety of combining selinexor with~     daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin~     and cytarabine will also be established.~   "
49951|NCT02403297|"~     The purpose of this study is to learn if a chair-side testing device will accurately measure~     levels of a salivary biomarker and thus indicate if a patient has periodontal health,~     gingivitis or periodontal disease.~   "
49952|NCT02403284|"~     In this research study, investigators will test the effects of an approved medication for~     diabetes,Liraglutide, to reduce insulin resistance that develops from eating a diet high in~     saturated fats.~   "
49953|NCT02403271|"~     This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in~     combination with durvalumab (MEDI4736) in subjects with relapsed or refractory solid tumors.~   "
49954|NCT02403258|"~     To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.~   "
49955|NCT02403245|"~     The aim of this study is to evaluate the direct impact of one session of social stimulation~     on social interactions of people with moderate dementia living in nursing home in comparison~     of one session without direct social stimulation.~   "
49956|NCT02403232|"~     Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported~     incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea,~     respectively. Uncontrolled chronic inflammation finally causes various complications in~     intestine such as bowel obstruction, fistulas, abscesses, and anal fissures.~      The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease.~     Medical treatment for Crohn's fistulae initially focused on surgical intervention~     accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most~     serious problem after surgical intervention is the relatively high incidence of~     postoperative anal incontinence caused by sphincter injury during the procedure. Conversely,~     available pharmacological therapies for Crohn's fistulae based on biologic agents such as~     infliximab do not generally reach ideal goal of treatment (e.g., complete closure of the~     fistula). A high recurrence rate after treatment with infliximab has also been reported,~     even after long-term maintenance therapy, which suggests that infliximab monotherapy does~     not provide adequate healing.~      The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a~     better clinical outcome, combination treatment with infliximab and surgical intervention is~     highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does~     not result in a satisfactory healing for many patients.~      The ideal therapeutic goal of treatment is not only complete closure of the fistula without~     recurrence but also preservation of anal sphincter function. Unfortunately, currently~     available medical or surgical treatment is not likely to offer a cure for perianal fistulae~     and, as noted above, recurrence is frequently reported.~      Together with active research in the field of bone marrow-derived mesenchymal stem cells~     (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem~     cells (ASCs) have been studied for management of Crohn's disease and other disorders.~      Of particular relevance to this study, ASCs could be considered to be safe and efficacious~     therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause~     fecal incontinence after injection into the lesion site in Crohn's disease patients. A phase~     I dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul,~     Korea) demonstrated the safety and therapeutic potential of these cells for the treatment of~     Crohn's fistulae. A phase II study demonstrated a good rate of cronh's related fistula~     closure using a ASCS injection.~      Actually the best accepted treatment of Crohn related perianal fistula, is the surgical~     procedure in association whit medical therapy.~   "
49957|NCT02403219|"~     This is a prospective, comparative, contralateral eye study. Patients older than 18 years~     who have had treatment with topical lubricants for at least 1 month and persist with~     symptoms of dry eye and corneal staining with fluorescein were included. Patients with dry~     eye attributable to abnormalities of the eyelids, nasolacrimal obstruction and active~     corneal infection, as well as patients with severe dry eye were excluded from the study. One~     eye randomly received a subcutaneous injection of botulinum toxin in the medial part of the~     lower eyelid, and the other eye received a similar procedure with placebo. The subjective~     evaluation was achieved with a questionnaire assessing symptoms of dry eye and~     conjunctivitis, quality of vision and ocular comfort level each eye separately. The~     objective evaluation included the measurement of the tear film break up time, Schirmer's~     test and with a modification of the Oxford grading scheme for corneal and conjunctival~     staining.~   "
49958|NCT02403206|"~     The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual~     capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as~     a cataract with a pressurized capsular bag.~   "
49959|NCT02403193|"~     The purpose of this study is to determine the safety, tolerability, feasibility and~     preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as~     single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1~     Ab)) to NSCLC patients.~   "
61184|NCT02256358|"~     Compare the effects of intravenous midazolam and ketamine on emergence agitation after~     sevoflurane anesthesia~   "
49961|NCT02402101|"~     Transcranial direct current stimulation (tDCS) is a technique that is emerging as a~     prospective therapy for neurologic, psychiatric and addictive disorders. Specifically,~     anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with~     improvement of cognitive functions and mood. Despite an increased use in clinical settings,~     tDCS suffers from limitations, especially regarding the strength and the duration of~     therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from~     the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly~     used in private settings through commercial apparatus and tutorials to make a~     do-it-yourself device delivering tDCS now available on the Internet. This private use~     worries neuroscientists and health authorities. Even if the general impression is that, in~     controlled conditions, tDCS is safe with only mild and transient adverse effects, whether~     and how tDCS could be used for enhancing cognition in healthy subjects are needed to~     investigate in more detail. The investigators believe that a better understanding of some~     neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and~     therapeutic applications and to define recommendations for a private use.~      As the cortex is densely connected with basal ganglia areas, including dopaminergic areas,~     tDCS is probably not only capable to target cortical but also subcortical structures remote~     from the stimulation sites. Some studies suggest that cortical stimulation by other~     approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased~     dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been~     investigated only indirectly in pharmacological studies. Thus, the direct effect of the~     DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.~      The aim of this project is to reveal the online impact of a single-session of tDCS applied~     bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by~     PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.~   "
49962|NCT02402088|"~     The purpose of this study is to examine the role of stress in food craving and food~     consumption in obesity. Using experimentally validated guided imagery procedure, the~     investigators propose to examine the stress response using subjective, physiological and~     neurobiological measurements.~   "
49963|NCT02402075|"~     During neurosurgical resection of brain tumors within brain areas for motor control, it is~     important to monitor motor function. For this muscle motor evoked potentials are used. Those~     are elicited by transcranial and direct cortical stimulation. Motor responses are recorded~     from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used,~     but additionally motor activity is recorded from the spinal cord. This is called spinal~     motor evoked potentials. It is known that the relation between spinal and muscle motor~     evoked potentials helps to extent the resection of spinal cord tumors. This study implements~     the spinal motor evoked potential into brain tumor surgery and analyses the relationship~     between spinal and muscle motor evoked potentials. With this, detection of injury to the~     brain area for motor control might be discovered earlier and thus tumor resection can be~     performed safely.~   "
49964|NCT02402062|"~     The purpose of this study is to determine the safety and the efficacy of the combination of~     the drugs TH-302 and sunitinib in metastatic neuroendocrine tumours.~   "
49965|NCT02402049|"~     The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women~     diagnosed as suffering from the syndrome with the DRSP questionnaire.~      The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be~     evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The~     questionnaire will be completed daily by women for 2 months prior to receiving the treatment~     and for 3 months following treatment with a single dose of the homeopathy treatment.~   "
49966|NCT02402036|"~     This is an exploratory biomarker study. Patients with metastatic colorectal cancer will~     receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive~     28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after~     starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after~     starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.~   "
49967|NCT02402023|"~     The purpose of this clinical trial is to determine the feasibility and efficacy of an~     intervention designed to increase rates of tobacco abstinence for cancer patients before~     their cancer surgery.~   "
49968|NCT02403154|"~     The purpose of this research is to compare patient outcomes of two treatment methods that~     are currently used as standard of care to treat anterior pelvic ring injuries that require~     stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and~     external fixation (EXFIX). Patients will be given the opportunity to opt out of~     randomization and participate in one of the observational arms. The first observational arm~     is comprised of those patients who do not want to randomize and they will undergo anterior~     pelvic ring stabilization according to the treating surgeon's discretion. The second~     observational arm will be comprised of patients who consent to be in the study but whose~     pelvic ring fractures do not require any form of anterior pelvic internal fixation based on~     the treating surgeon's opinion.~   "
49969|NCT02403141|"~     Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing~     awareness, remains under-diagnosed. There is a close association between OSA and obesity;~     60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very~     common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached~     epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain~     through sleep disturbance [2]. Several mechanisms have been proposed for the associations of~     OSA with diabetes and obesity [3]. At present there is little available information~     regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the~     impact of OSA on health outcomes in the Emirati population. This research will explore these~     relationships and inform public health decisions regarding diagnostic pathways, service~     provision and treatment protocols.~   "
49970|NCT02403128|"~     Phase 1, non-randomized, open label, noncomparative trial to study the effect of~     intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal~     artery macroaneurysms.~   "
49971|NCT02403115|"~     The purpose of this study is to clarify the mechanisms involved in the formation and~     glomerular deposition of immune complexes in lupus nephritis.~      The determination of an antibody pattern specific for systemic lupus erythematosus and lupus~     nephritis may also have a role in predicting disease progression in patients with systemic~     lupus erythematosus without renal impairment. As for the patients enrolled in the study, the~     determination of their antibody patterns may contribute to a more targeted and personalized~     treatment, allowing a prediction of disease progression and the introduction of early~     targeted treatments, in order to block the onset and/or progression of renal damage.~   "
50033|NCT02402283|"~     The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400~     mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg~     metronidazole per film coated tablet)/Zentiva.~   "
49972|NCT02403102|"~     Theranostics is the use of a diagnostic test to decide which patients will benefit from a~     certain treatment.~      The current standard treatment for patients with myeloma is induction chemotherapy followed~     by peripheral stem cell transplant. Although there are options for timing of treatments,~     patient outcomes are variable and the investigators do not currently know which patients~     benefit from which treatment schedule. There is evidence to suggest that residual disease on~     imaging after treatment is an indicator for a worse prognosis, however the best time point~     for this imaging is currently not known. This study is designed to show if there is an~     optimum time point for correlation between imaging and prognosis.~      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and~     the investigators will confirm this when patients are first diagnosed, by performing both~     FDG PET/CT and whole body diffusion weighted MRI.~      Patients will then be followed up with whole body diffusion weighted MRI after induction~     chemotherapy and 3 months post autograft. The investigators will look at the amount of~     disease present on these scans and correlate this with outcomes.~      There are likely to be other factors which influence patient outcomes (such as genetics) and~     the investigators will also look at some of these. Patients who undergo autograft have~     regular blood tests and marrow samples taken as part of routine care, the investigators will~     use some of these samples (without compromising the patients treatment) to analyses some of~     these other factors. If the investigators are able to determine a correlation of genetic~     factors with outcome this information could be used in future research.~      Theranostics is the use of a diagnostic test to decide which patients will benefit from a~     certain treatment.~      The current standard treatment for patients with myeloma is induction chemotherapy followed~     by peripheral stem cell transplant. Although there are options for timing of treatments,~     patient outcomes are variable and the investigators do not currently know which patients~     benefit from which treatment schedule. There is evidence to suggest that residual disease on~     imaging after treatment is an indicator for a worse prognosis, however the best time point~     for this imaging is currently not known. This study is designed to show if there is an~     optimum time point for correlation between imaging and prognosis.~      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and~     the investigators will confirm this when patients are first diagnosed, by performing both~     FDG PET/CT and whole body diffusion weighted MRI.~      Patients will then be followed up with whole body diffusion weighted MRI after induction~     chemotherapy and 3 months post autograft. The investigators will look at the amount of~     disease present on these scans and correlate this with outcomes.~      There are likely to be other factors which influence patient outcomes (such as genetics) and~     the investigators will also look at some of these. Patients who undergo autograft have~     regular blood tests and marrow samples taken as part of routine care, the investigators will~     use some of these samples (without compromising the patients treatment) to analyses some of~     these other factors. If the investigators are able to determine a correlation of genetic~     factors with outcome this information could be used in future research.~   "
49973|NCT02403089|"~     The objective of this study is 1/ to determine the rate and kinetics of MAIT cell expansion~     and maturation in neonates in relation with gestational age, and in HSCT recipient children~     in relation with the source of donor stem cells, 2/ to correlate gut microbiota diversity~     and function with MAIT cell maturation and function in neonates and HSCT recipients; and 3/~     to link MAIT cells and gut microbiota composition with microbial infections and severe~     intestinal inflammatory events in term and preterm neonates, and in HSCT recipients~   "
49974|NCT02403076|"~     Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a~     few data exists for the emergency management of patients with acute gastrointestinal~     bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms~     for the management of acute upper and lower gastrointestinal bleedings.~   "
49975|NCT02403063|"~     It was recently shown that neostigmine reversal was associated with increased atelectasis~     and that high-dose neostigmine was associated with longer postoperative length of stay and~     with an increased incidence of pulmonary edema and reintubation. These study results were~     consistent with findings from a previous epidemiological study which revealed an absence of~     beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our~     previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the~     electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This~     could be explained by a possible effect on neuromuscular transmission at the muscle level,~     but can also be explained by a neostigmine-induced decrease in total nerve activity. In a~     study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The~     investigators aim to show a difference in phrenic nerve activity between neostigmine and~     sugammadex, administered alone or in combination, in healthy male volunteers.~   "
49976|NCT02403050|"~     Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated~     with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy,~     a Computerised tomography (CT) scan is performed and is the dataset used for planning~     radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine~     staging, is used to help localize the tumor, as tumors of the esophagus are poorly~     visualised on CT. This information is subjective and dependant on the clinician performing~     the procedure. The tumor is described in relation to common anatomical landmarks.~     Interpretion of this information can lead to over-compensation when attempting to cover the~     tumor with a radiation field, to avoid a miss. It is thought that using fiducial markers~     called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of~     EUS, will lead to better definition of the tumor in the planning process and hence,~     improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.~   "
49977|NCT02403037|"~     To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial~     using a standard auricular acupressure protocol for managing nausea and vomiting in a~     homogenous group of female breast cancer patients undergoing chemotherapy.~      The null hypotheses of this study are: (1) There will be no significant difference in the~     occurrence, frequency and severity of acute/delayed nausea and vomiting among groups during~     the intervention period; (2) There will be no significant difference in the occurrence,~     frequency and severity of anticipatory nausea and vomiting among groups before the second~     cycle of chemotherapy; (3) There will be no significant difference in quality of life status~     among groups at the end of the first cycle of chemotherapy.~   "
49978|NCT02403024|"~     Background: The level physical exercise is strongly associated with colorectal cancer risk~     in the general population, and recent data shows that physical activity after a colorectal~     cancer diagnosis is inversely associated with mortality risk, indication the physical~     exercise can protect against disease progression. However, few studies have successfully~     performed exercise interventions in patients with colorectal cancer, and the potential~     mechanisms responsible for the tumor suppressing effects of exercise remain poorly explored.~      Purpose: To investigate interval-walking, delivered by the InterWalk smart phone application~     as exercise-modality in patients with colorectal cancer. Specifically it is the aim to~     explore if InterWalk is safe and feasible as well as effective to improve cardio-metabolic~     health profile.~      Subjects: Colorectal cancer patients, stage I-III, who are at least one month post-surgery~     and have concluded any adjuvant chemotherapy treatment, are eligible for inclusion.~     Exclusion criteria are: age <18; any major surgical procedure planned within 6 months after~     inclusion; pregnancy; ongoing treatment for any known malignancy; performance status > 1;~     unable to read and understand Danish~      Methods: 40 colorectal cancer patients are included and randomized to I) InterWalk or II)~     waiting list control for 24 weeks. Patients are evaluated at baseline, week 12 and week 24~     by assessment measures to determine cardio-metabolic health profile and other relevant study~     outcomes, including: cardiopulmonary exercise test (VO2peak); anthropometrics; blood~     pressure; resting heart rate; body composition; health related quality of life~     questionnaires; plasma concentration levels of cholesterol, triglycerides, insulin, glucose~     and inflammatory cytokines; insulin sensitivity; and cognitive function.~   "
49979|NCT02403011|"~     This study investigates the effect of soft tissue mobilization in babies with neck muscle~     problem. Babies received soft tissue mobilization or home exercises program~   "
49980|NCT02402998|"~     A clinical study to evaluate the efficacy of a drug called eltrombopag in adult patients~     affected of primary immune thrombocytopenia as first treatment to address the disease.~   "
49983|NCT02402959|"~     The primary purpose of this study is to discover, establish and refine the individual~     treatment protocol of each TCM expert for insomnia, and to explore what characteristics of~     the patients are considered with the corresponding treatment in clinical practices.~      The secondary purpose is to determine the effectiveness of TCM pattern differentiation~     treatment for the patients with insomnia.~   "
49984|NCT02402946|"~     Rumination syndrome is characterized by effortless recurrent regurgitation of recently~     ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a~     previous study we showed that rumination is produced by an unperceived, somatic response to~     food ingestión. After having identified the key mechanisms of rumination, we developed an~     original EMG guided biofeedback technique with specific targets for correction, based on~     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed~     the potential effectivity of this treatment. In a subsequent study this technique was~     validated by a formal placebo-controlled, randomized trial. The current aim is to test the~     efficacy of a simplified biofeedback technique not requiring EMG-guided control.~   "
49985|NCT02402933|"~     Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at~     time of enrolment will be selected for inclusion in the study. The target is to obtain~     treatment response and user-experience data following use of AMG504-1 in treating episodes~     of hypoglycemia.~   "
49986|NCT02402920|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pembrolizumab (also called MK-3475) and radiation therapy (either with chemotherapy or~     alone) that can be given to patients with SCLC.~   "
49987|NCT02402907|"~     The objective of this study is to determine if the use of chlorhexidine gluconate cloths~     prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site~     infections, endometritis).~      The study will be offered to women who present for a scheduled primary or repeat cesarean~     section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2%~     chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the~     night before and the morning of their scheduled procedure. Participants will be blinded to~     the arm in which they have been assigned. This study intends to show that the use of 2% CHG~     cloths prior to cesarean section will reduce the rate of surgical site infections.~   "
49988|NCT02402894|"~     The purpose of the study is to study how a person-centered structured team caretaking of~     young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA)~     and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and~     ability to manage their everyday lives. Also included in the project is a long-term~     follow-up (up to 50 years) where the investigators want to investigate factors predicting~     good general health, low disease activity, good physical function, and comorbidity.~   "
49989|NCT02402881|"~     The investigators have recently developed a registry of missed doses of VTE prophylaxis that~     includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE~     prophylaxis refusal, the group has developed a patient-centered education bundle that will~     be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting~     education materials include a 2-page education sheet and an educational video.~      The investigators hypothesize that patient refusal of VTE prophylaxis is associated with~     significant knowledge gaps among patients regarding their risk of developing VTE and the~     benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse~     VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.~   "
49990|NCT02402868|"~     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard~     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in~     the paediatric population. The aim is to assess if IN administration is equivalent to the~     current standard of care, IV. The population to be studied is children 5-17 years of age who~     require a simple orthopaedic reduction. Following a double dummy approach to overcome the~     difficulty in masking interventions, each participant will recieve both IV and IN~     interventions, only one of which will be the real drug. Procedural conscious sedation (PCS)~     will be assessed using the University of Michigan Sedation Scale (UMSS).~   "
49991|NCT02402855|"~     This study aims to evaluate the impact of financial support on improving the management of~     prenatal care in pregnant women with low incomes. The judgment criterion is clinically~     pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this~     approach through a qualitative survey.~      It is planned to include 4000 women distributed into two arms of 2000 each. One group will~     receive financial support (prepaid payment card credited for each consultation attended~     according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the~     other group will not. The management of the pregnancy for both groups will not be modified.~   "
49992|NCT02402842|"~     Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at~     an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and~     5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure~     (including salvage surgery), cisplatin-5FU combination is the standard option but complete~     response is a rare event and the prognosis remains poor with most patients' death occurring~     in the first 12 months. Decision making for physicians in this setting is only based on~     retrospective studies or small phase II clinical trials including less than 20 patients.~     Hence, no efficient standard of care is currently available for relapsing SCCA patients who~     are currently treated with a palliative intent.~      Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were~     treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer~     Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved~     a complete response. Three patients underwent surgery of all involved metastatic sites. A~     pathological complete response was observed for all of them including in metastases~     occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an~     effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8~     patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete~     responders were HPV 16, and high levels of specific T cell responses against Human~     Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete~     responders suggesting the potential restoration of cancer immunosurveillance by this~     regimen.~      Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of~     taxane-based chemotherapy in SCCA patients.~   "
49993|NCT02402829|"~     The purpose of this research study is to see if factor levels and inhibitor levels in~     Hemophilia A and B subjects are accurate when they are drawn from a central venous line~     (CVL) instead of from a peripheral stick.~   "
49994|NCT02402816|"~     The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in~     the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD~     implant.~   "
49995|NCT02402803|"~     Cardiovascular disease (CVD) is the number one cause of mortality for men and women in the~     United States. Dyslipidemia, particularly a high low-density-lipoprotein cholesterol (LDL-C)~     level, is a well-established cardiovascular risk factor and the current American Heart~     Association guideline for CVD risk assessment recommends a lipid panel to be checked. In~     addition, guidelines recommend statin therapy in all patients with clinical atherosclerotic~     CVD, all patients with LDL-C = 190 mg/dL, patients age 40-75 years with diabetes and LDL-C~     70-189 mg/dL, and patients with an estimated 10-year atherosclerotic CVD risk = 7.5%. For~     all of these patients, a fasting lipid panel should be drawn prior to statin initiation as~     well as during follow-up to assess medication and lifestyle adherence. These fasting lipid~     panels are obtained via conventional phlebotomy via venopuncture in an office-based or~     hospital laboratory setting. However, research protein quantitation with mass spectrometry~     and enzyme-linked immunosorbent assay (ELISA) are technologies that allow for sensitive~     quantitation of protein biomarkers and targets, including lipoproteins. Most importantly,~     multiple reaction monitoring (MRM) mass spectrometry is able to assess samples from a dried~     blood spot (DBS), whose advantages include minimal volume requirements, ease of sample~     attainment by finger stick with minimal training required, ease of transport, and sample~     stability.~      The purpose of the proposed analysis is to 1) measure changes in CVD biomarkers before and~     after initiation of statin therapy and 2) compare lipid measurements by conventional~     phlebotomy blood samples to research protein quantitation measurements in DBS and plasma.~   "
49996|NCT02402764|"~     The main purpose of this study is to see whether the combination of selinexor (KPT-330) can~     help people with triple negative breast cancer (TNBC). Researchers also want to study the~     safety and tolerability of Selinexor in TNBC patients.~   "
49997|NCT02402751|"~     The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU)~     obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a~     hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop~     new diagnostic approaches.~      The purpose of this study is to develop, implement and validate new MRI quantitative~     parameters derived from ultra high field MRI in order to characterize non-invasively with an~     unprecedented resolution and sensitivity, anatomy as well as certain physiological,~     hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart~     in healthy subjects~   "
49998|NCT02402738|"~     Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness. The perinatal~     period dramatically increases risk for mood episodes in women with BD, but pregnancy~     complicates pharmacologic treatment decisions and efficacy. This study will be the first to~     systematically develop and pilot test an adjunctive psychosocial intervention to assist in~     treatment of BD during the high-risk perinatal period.~   "
49999|NCT02402725|"~     This is a phase II, open label, single-center study of ultra-high dose dexamethasone~     administered intravenously and orally as monotherapy for the treatment of relapsed multiple~     myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively~     both alone, and in combination with other agents, in the treatment of multiple myeloma.~      This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled.~     Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately~     followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day~     cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more~     of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an~     additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur~     after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience~     a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until~     progression, intolerable side effects, or death.~      The purpose of the proposed phase II study is to determine the overall response rate,~     progression free survival, and tolerability of ultra-high dose dexamethasone.~   "
50000|NCT02402712|"~     This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and~     tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female~     patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients~     are to receive study medication until disease progression, unacceptable toxicity, withdrawal~     of consent, death, or predefined study end, whichever occurs first. The anticipated time on~     study treatment is approximately 24 months. The target sample size is 400.~   "
50001|NCT02402699|"~     This protocol is being conducted to comply with the direct request from the Taiwan Food and~     Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients~     with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on~     antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable,~     recurrent or metastatic) Melanoma.~   "
50002|NCT02402686|"~     The aim of this non-interventional study in Hungarian patients is to gather real life data~     about the efficacy and safety of tocilizumab subcutaneous (SC) monotherapy in rheumatoid~     arthritis and to assess data about pattern of usage of tocilizumab monotherapy in rheumatoid~     arthritis (RA) disease management.~   "
50003|NCT02402673|"~     Problem: Adolescent patellofemoral pain (PFP) is a major problem worldwide and affects 7% of~     adolescents. Adolescents with PFP have long-lasting severe pain and low quality of life.~     Current treatment is ineffective for more than 60% and new treatment approaches are needed.~      Solution: A novel multidimensional diagnostic approach combining imaging, physical activity~     level and pain sensitisation in adolescents with PFP. This approach will enable the~     identification of adolescents with PFP who benefits from a new treatment strategy using~     activity modification to reduce loading of the patellofemoral joint and graded exercises to~     improve loading capacity.~   "
50004|NCT02402660|"~     The purpose of this study is to determine the long term safety and tolerability of ALK-001~     (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of~     Stargardt disease in patients between the ages of 12 and 60 years old.~      Funding Source - FDA OOPD~   "
50005|NCT02402647|"~     This project will utilize a novel behavioral intervention for hoarding disorder that takes~     into account age and neurocognitive factors. The goal of this project is to gain knowledge~     on how treatment components may or may not work for Veterans with hoarding disorder.~     Further, the investigators hope to increase understanding of functional and long term~     outcomes in response to hoarding treatment.~   "
50006|NCT02402634|"~     Mechanical ventilatory lung care is essential for postoperative care in liver~     transplantation recipients, for such patients are under massive fluid challenge and~     hemodynamic alterations perioperatively. Some of the recipients experience difficulty in~     weaning off from the mechanical ventilator due to various causes. This study is to~     investigate the relationship between the inflammatory gene polymorphism, known for acute~     lung injury, and the duration of mechanical ventilatory care for such liver transplantation~     recipients.~   "
50007|NCT02402621|"~     Comparing postoperative analgesics requirements and complications between conventional and~     model-based infusion strategy of intravenous patient-controlled analgesia in patients who~     undergoing robot assisted laparoscopic radical prostatectomy~      Group A: conventional intravenous patient-controlled analgesia, Group B: model-based~     infusion strategy of intravenous patient-controlled analgesia~   "
50008|NCT02402608|"~     This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the~     hypothesis that nutritional supplementation with whey protein, essential amino acids and~     vitamin D concurrent with regular, controlled physical activity would increase muscle mass,~     strength, physical functional, quality of life, and decrease the risk of malnutrition and~     inflammation in sarcopenic elderly.~   "
50009|NCT02402595|"~     The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor,~     itraconazole, on the steady-state PK of AVP-923 and AVP-786.~   "
50010|NCT02402582|"~     Implementing the Family-centered Empowerment Model (FCEM) as a new Cardiac Rehabilitation~     program for Myocardial Infarction patients with four-stage including perceived threat with~     group discussion method, self-efficacy with problem solving method, self-esteem with~     educational partnership and outcome and process evaluations~   "
50011|NCT02402569|"~     This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a~     multi-electrodes set.~   "
50012|NCT02402556|"~     The purpose of the Mother Child Education Program (MOCEP)—a group-based early childhood~     development parenting education program—is to provide school-readiness and parenting skills~     to mothers of young children who do not have access to preschool education services. The~     MOCEP intervention also provides a setting in which caregivers can model pro-social~     behaviors and practice conflict resolution techniques directly with young children.~   "
50013|NCT02402543|"~     The perianal region is the region around the anus. Administering a pain medication before a~     surgery starts is called preemptive analgesia. In some studies, this technique has been~     shown to be an effective way to reduce the pain that a patient experiences in the~     post-operative timeframe to a greater extent than would be expected simply from the pain~     medications alone. One theory of why this occurs suggests that the preemptive analgesia~     desensitizes brain and nerves to pain, thereby decreasing the response to painful stimuli,~     like surgery when they occur. This leads to a decrease in the amount of narcotic pain~     medication required after the procedure, which leads to less side effects and a quicker~     return to normal functioning. As perianal surgeries do not usually include a long stay in~     the hospital, controlling post-procedure pain is a priority.~      The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well~     established, but as the perianal region has not been well studied, its use is not the~     standard of care. This type of analgesia uses a combination of medications that are already~     in use for post-operative and non-operative pain control and administers them orally prior~     to the patient undergoing general anesthesia. The side effects of the medications are the~     same as if they had been given after surgery or for non-surgical pain.~      The concept of preemptive analgesia is established in other types of surgeries and it has~     solid basic science to support its use. The purpose of this randomized, double-blind,~     placebo controlled study is to determine if patients undergoing perianal surgeries could~     benefit from preemptive pain control. The primary outcome will be whether patients~     experience less post-operative pain. Patient post-operative consumption and latency until~     use of narcotic pain medication will be the secondary outcomes. The investigators believe~     that the patients receiving pain medications before their operation will require less pain~     medication after surgery, with minimal increased risk to the patient.~   "
50014|NCT02402530|"~     This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the~     treatment of pain associated with complex regional pain syndrome type I (CRPS-I).~      The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and~     an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended~     follow-up period will be terminated for all participants after the last participant enrolled~     completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the~     12-week trial period and extended follow-up period.~   "
50015|NCT02402517|"~     The objectives are to test the acute effects of different extruded pulse snacks on: 1)~     aerobic endurance and substrate oxidation during exercise 2) response of blood glucose,~     insulin and appetite on an aerobic exercise session, and 3) food intake two hours following~     the exercise session. The investigators hypothesize that consumption of food products~     containing pulse ingredients 60 minutes before exercise will increase aerobic endurance~     (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient),~     and a reduction in lactate production during compared to the same exercise session following~     the ingestion of a non-pulse food. The investigators also hypothesize that consumption of~     extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake,~     suggesting lower calorie compensation, following a 60-minute aerobic exercise session~     compared to the same exercise session following the ingestion of a non-pulse food.~   "
50016|NCT02402504|"~     The objectives are to test the acute effects of different extruded pulse snacks on: 1)~     post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two~     hours following consumption of pulse products.~      The investigators hypothesize that snack products containing pulse ingredients will lead to~     lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack~     products.~   "
50017|NCT02402491|"~     Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis~     (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months~     of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all~     patients continue receiving aspirin indefinitely. The primary efficacy end points of this~     study are the incidence of a composite end point including all cause deaths, myocardial~     infarction, the incidence of Academic Research Consortium defined definite or probable stent~     thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of~     GUSTO moderate or severe bleeding.~   "
50034|NCT02402270|"~     The purpose of this study is to learn about a new bowel preparation that uses food to clean~     the colon.~      In order to learn about this new food preparation, some people in this study will get the~     food preparation, and others will get the standard liquid bowel preparation.~      Patients will be randomized (like flipping a coin) to one of five groups:~      Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B~     Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains~     bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY~   "
50018|NCT02402478|"~     The purpose of this study is to advance research through collaboration, 4C was established~     in the United Kingdom (UK) in 2009 as a resource in which deoxyribonucleic acid (DNA) and~     biomarker samples were obtained at time of presentation with chest pain linked to detailed~     phenotypic data obtained from electronic health records and participant self-completed~     questionnaires. The investigators sought to explore and assess the current potential of~     setting up a comparable consented research platform by collecting DNA samples and to~     quantify the extent to which diverse NHS hospital information systems are accessible for~     extracting secondary care data (structured and unstructured) for research purposes at scale.~   "
50019|NCT02402465|"~     Dymista, a combined product containing the antihistamine azelastine and the intranasal~     steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and~     azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of~     efficacy not only occurs at the initiation of treatment, but persists for its duration. The~     mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on~     examining the effects of Dymista on the dynamics of the allergic response in man using nasal~     provocation with antigen. The investigators will study the relationship between symptoms,~     physiology, cells and mediators.~   "
50020|NCT02402452|"~     This study will evaluate the pharmacokinetics, safety, and tolerability of GS-9857 in adults~     with severe renal impairment and matched healthy control adults.~   "
50021|NCT02402439|"~     The goal of this trial is to gain initial clinical experience regarding the safety and~     efficacy of treating type I diabetes in people who have received a kidney transplant by~     transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa).~     A total of 6 patients will be enrolled in the study and followed for a period of 3 years~     after the last islet transplant.~   "
50022|NCT02402426|"~     The overall goal of this project is to identify, assess and longitudinally monitor subjects~     who are interested in participating in brain research. Participants will enroll through the~     website, BrainHealthRegistry.org, and provide informed consent prior to any study~     activities. The website will collect a variety of information, including participants'~     overall health, memory complaints, family history of dementia and Alzheimer's disease (AD),~     mood status, sleep, diet, and exercise—all through self-reported online questionnaires.~     Participants will also be ask to take online cognitive tests, and to return to the website~     at regular intervals, to complete follow-up questionnaires and neuropsychological~     assessments. Everyone over the age of 18 is welcome to participate. To join the Brain Health~     Registry, please visit www.BrainHealthRegistry.org.~   "
50023|NCT02402413|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in~     women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is~     characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual~     cycles, hyperandrogenism, and polycystic ovarian morphology.~      An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume,~     evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the~     ovary. It has been shown that when this ratio is higher than a third the levels of~     circulating androgens and high. Aim of the present study is to assess whether this ratio,~     determined with three-dimensional ultrasound, is correlated to the increase of androgens.~   "
50024|NCT02402400|"~     Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in~     ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.~   "
50025|NCT02402387|"~     The purpose of this study is to investigate the changes of the oropharyngeal leak pressure~     of the air-Q self-pressurizing masked laryngeal airway in the different head and neck~     positions. Moreover, the adequacy of ventilation will be assessed in the different head and~     neck positions.~   "
50026|NCT02402374|"~     Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the~     treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore,~     a larger randomized, placebo-controlled clinical trial will be useful to determine whether~     platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).~   "
50027|NCT02402361|"~     Understanding risk factors and determinants for neuropathic pain.~   "
50028|NCT02402348|"~     The study researchers want to look at the overall effects that Metformin may have on the~     tumor characteristics of Head and Neck cancer cells as well as the interactions that~     Metformin has on the growth or death of tumor cells.~   "
50029|NCT02402335|"~     The purpose of this study is to examine whether there are relations between different types~     of pain in groups of patients with different diagnoses of degenerative diseases of the~     spinal column and their related surgeries.~   "
50030|NCT02402322|"~     The aim of this study was to compare two ways of administrating the complementary~     psychological support (scheduled vs. non-scheduled) in an online self-help program for panic~     disorder. In order to do so, the investigators studied: a) If there were differences in the~     intensity and frequency of the symptoms of panic disorder. b) If there were differences in~     the therapeutic adherence between the subjects receiving both kinds of complementary~     support. c) If the more time spent by a psychologist in therapeutic interventions produced~     the best results of therapeutic adherence / symptom improvement.~      Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had~     the support of a therapist via phone when they required it, 25 subjects had the support of a~     therapist weekly and 25 subjects were in the waiting list as a control group.~   "
50031|NCT02402309|"~     This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study~     designed to evaluate the safety, PK, and exploratory activity of topically-applied NS2~     dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to~     Sjögren- Larsson Syndrome (SLS).~      NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby~     diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated~     with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.~   "
50032|NCT02402296|"~     combining the non-surgical therapy with a well-tolerated substance that can stimulate~     protective immune responses like B-glucan, might effectively mount resolution pathways~     contributing to resolving of the chronic lesion observed in aggressive forms of periodontal~     disease.~   "
52660|NCT02367885|"~     The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular~     injection of TAK-850 in healthy pediatric Japanese participants.~   "
50035|NCT02402257|"~     The investigators previously successfully implemented a central venous catheter (CVC)~     simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result,~     trainee skill improved, complications, including central line associated bloodstream~     infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the~     Veterans Administration Medical Centers (VAMC) decided to implement this training at some of~     their sites as a quality improvement project. The investigators will train faculty at these~     locations to implement the same curriculum at their individual sites. Outcome data will be~     collected to evaluate the outcomes of the quality improvement (QI) project (complications,~     infections, skills).~   "
50036|NCT02402244|"~     This research trial studies the Project: Every Child for younger patients with cancer.~     Gathering health information over time from younger patients with cancer may help doctors~     find better methods of treatment and on-going care.~   "
50037|NCT02402231|"~     Severe peanut allergy is different from other allergic reactions because it can lead to~     fatal reactions and is an invisible disability. There is no cure today. The purpose of this~     study is to treat children and adolescents with severe peanut allergy with oral~     immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies~     (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by~     basophil cell stimulation (CD-sens).~   "
50038|NCT02402218|"~     This study is being done to compare three ways to give the study drug Harvoni (a tablet that~     includes two drugs also called Sofosbuvir/Ledipasvir) for 12 weeks in people who are~     infected with both Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Subjects~     will receive this drug as part of the study. Subjects will be randomized into one of three~     treatment groups:~        1. Usual care in the clinic. This treatment group will receive the standard of care for~          HCV treatment from their health care team.~        2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational~          strategy in which participants assigned to this group will be asked to interact with a~          peer-mentor who is someone who has been cured of their HCV infection.~        3. Usual care plus incentives. In addition to the usual care, this is an investigational~          strategy in which participants assigned to this group will be given incentives after~          completing certain treatment goals during the course of the study.~      HCV treatment with Harvoni is considered the standard of care for HCV and is recommended by~     experts in liver disease and infectious diseases.~   "
50039|NCT02402205|"~     Adjudicated youth often have traumatic stress responses but rarely receive treatment for~     these problems. This study is a randomized controlled trial to evaluate two alternative~     implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused~     Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18~     residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1)~     web-based TF-CBT implementation strategy (W), consisting on only web-based training and~     consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus~     face-to face training and phone consultation with TF-CBT experts (W+L).~   "
50040|NCT02402192|"~     The study is proposed to determine the effect of three types of gonadotropins that are~     currently used in protocols of controlled ovarian stimulation in women undergoing in vitro~     fertilization techniques on the kinetics of embryonic development.~   "
50041|NCT02402179|"~     Our objective is to determine the metabolic availability of Tryptophan in white maize using~     the indicator amino acid oxidation (IAAO) technique in adult men.~   "
50042|NCT02402166|"~     The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and~     efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with~     ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD~     population.~   "
50043|NCT02402153|"~     To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia~     alarm device~   "
50044|NCT02402140|"~     Primary end-point~      The primary end-point was the influence of pharmaceutical intervention in tacrolimus~     intra-subject variability during the first 3 months after kidney transplant. Coefficients of~     variation were calculated from the average of dose-corrected tacrolimus blood~     concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60~     and 90 post kidney transplant.~      Secondary end-points~        1. Secondary outcomes included evaluate percentage of patients who achieved target levels~          of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney~          transplant;~        2. Tacrolimus bioavailability profile during the period of 3 months,characterized by mean~          and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);~        3. Assess patient adherence through validated questionnaire Portuguese version of Basel~          Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale. It consists of a~          four-item questionnaire measuring nonadherence to immunosuppressives over the past four~          weeks. This questionnaire assesses omission of single doses or successive doses, timing~          deviations >2h and dose reductions. Responses are given on a six-point scale: never,~          once per month, every second week, every week, more than once per week and every day.~          Patients that answer different from never in any of the four questions are considered~          as nonadherent;~        4. We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);~        5. We evaluated Incidence of Infections;~        6. We evaluated Treated acute rejection episodes;~        7. We evaluated Death cases;~        8. We evaluated Graft loss cases;~        9. We evaluated Discontinuation of immunosuppressive treatment;~       10. We evaluated Hospital readmissions.~      Study Design~      This was a single-center, prospective, randomized and controlled study to evaluate the~     influence of pharmaceutical intervention in tacrolimus intra-subject variability during the~     first 3 months after transplantation. The authors designed the protocol, acquired and~     maintained the data, and conducted the statistical analysis. The protocol was approved by an~     independent ethics committee. All subjects signed a written informed consent before~     enrollment and the study was conducted according to good clinical practices and declaration~     of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December~     2014, 128 randomized and were followed for 3 months after transplantation.~   "
50045|NCT02402127|"~     The purpose of this study is to measure the coefficient of friction of three silicone~     hydrogel, daily disposable contact lenses after 16 hours of wear.~   "
50065|NCT02401776|"~     -  The primary objective of this study is to assess the effect of an energy drink on~          ventricular repolarization as measured by the interval between the cardiac Q wave and~          the cardiac T wave (QT interval)obtained from the body surface ECG.~        -  The secondary objective is to assess the effects of an energy drink on heart rate and~          blood pressure (hemodynamic effects).~      To place the observed changes in context, comparison will be made to a commonly consumed~     drink, coffee: Starbuck's K-cup Breakfast Blend.~   "
50066|NCT02401763|"~     Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its~     biomarker is important for understanding the mechanism of its pathogenesis.~   "
50379|NCT02397694|"~     This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +~     emtricitabine/tenofovir alafenamide (FTC/TAF) fixed dose combination (FDC) versus~     dolutegravir (DTG) + FTC/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This~     study will also evaluate the pharmacokinetic (PK) profile of BIC, FTC and TAF.~   "
50046|NCT02402114|"~     Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after~     exposure to a dangerous or life-threatening event. It is characterized by persistent fear-~     and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.~     These symptoms can interfere significantly with patients' lives and in some cases can be~     debilitating. One of the most frequent causes of PTSD is being a victim of a violent,~     interpersonal assault.~      PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded~     too strongly in a patient's long term memory, remaining too accessible and present to the~     patient long after the actual threat has passed. In recent years evidence has emerged that~     it may be possible to prevent PTSD by moderating the process of memory consolidation that~     occurs in the hours and days after a traumatic event.~      Early research has suggested that enhancing the body's natural cortisol response to a~     stressful event may be a safe and effective way of moderating the process of memory~     consolidation and promoting adaptive, non-pathological memory encoding. In particular, the~     administration of hydrocortisone, a safe and widely used drug that mimics the body's own~     cortisol hormone, appears to reduce the risk of developing PTSD in patients who have~     sustained a traumatic event. However, this research is still in relatively early stages, and~     requires larger trials to confirm its efficacy. In addition, the research thus far has not~     adequately targeted assault victims, whom we feel are some of the patients most likely to~     benefit from such an approach.~      We propose a prospective, placebo-controlled, double-blinded trial of administering~     single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein~     Medical Center Philadelphia Emergency Department to determine if this approach has efficacy~     in preventing PTSD. This study is designed as a pilot study, with the hopes that the data~     gathered in it can be used to design a larger and more robust trial in the future.~   "
50047|NCT02402010|"~     As a practice that incorporates elements of physical exercise, controlled breathing, and~     meditation, yoga is gaining increasing acceptance as an adjunctive intervention for many~     psychiatric disorders. Although yoga has been frequently recommended as a symptom management~     strategy for bipolar disorder (BD), and although there is some preliminary evidence that~     yoga may be helpful in alleviating depressive symptoms, there are no systematic studies on~     the benefits - and potential risks - of the practice of yoga in BD. The primary aim of the~     proposed study is to develop and evaluate the feasibility, acceptability, and safety of an~     adjunctive yoga intervention for bipolar depression in a 10 week pilot randomized controlled~     trial (RCT).~   "
50048|NCT02401997|"~     To determine the ideal sexual abstinence time for producing high quality sperm~   "
50049|NCT02401984|"~     Mental disorders are common in youth and adults. Symptoms of mental are aggravated by~     unemployment. Compared to the working population, the unemployed have higher rates of poor~     health, a tendency toward negative emotionality and depression, show symptoms of exhaustion~     more frequently, and experience disturbed sleep or have a sleep disorder. It can be~     reasonably expected that unemployment in adolescents and young adults causes the same~     symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an~     untreated one, the transfer from school to the employment market can be hindered. At the~     same time, the investigators notice an increase in early disability pensions due to mental~     health issues among adolescents. Thus, the early recognition and treatment of mental~     disorders and psychological strain is crucial in promoting the employment of young people~     and supporting their connection to the employment market.With this project the investigators~     want to implement an early intervention and reach out to unemployed youth. The investigators~     identified the period between graduation and first employment as the ideal moment of~     intervention, because this time period is a critical period in which young people are~     exposed to increasing personal challenges. Conducting an intervention before a psychological~     stress transforms into a mental disorder, can prevent harm and suffering to the afflicted~     person. In addition, early intervention could help prevent the need to enroll in the early~     disability pension program.~   "
50050|NCT02401971|"~     Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11)~     gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide~     in patients with diagnosis of gastric cancer. The main purpose of this study is to~     investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer.~     The investigators will also manage to find out the possible interactions between CPT-11~     pharmacokinetics and thalidomide to explain the previously described gastrointestinal~     toxicity reduction.~   "
50051|NCT02401958|"~     ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and~     progressive disease that can lead to joint destruction and important functional disability.~     Chronic inflammation, with a substantial increase in the amount of pro-inflammatory~     cytokines in synovial joint, is one of the biggest challenges in controlling RA. Resistance~     exercise has been recognized for positively modulate inflammation in healthy subjects.~     Objective: To evaluate the effect of an acute bout of resistance exercise on serum~     concentrations of tumor necrosis factor alpha (TNF-α), interleukin 1 receptor~     antagonist(IL-1ra), interleukin 1 beta (IL-1β), C reactive protein (CRP), interleukin 6~     (IL-6), interleukin 10 (IL-10), and cartilage oligomeric matrix protein (COMP) in~     postmenopausal women with RA and women without the disease. Methods: 17 volunteers with RA~     and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise~     session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8~     repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip~     abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes~     before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session. Serum~     glucose concentrations prior to exercise were also measured. The investigators used the~     Student's't test, the model of analysis of variance with repeated measures and Bonferroni~     method of multiple comparisons to analyze the data, being considered statistically~     significant levels of p <0.05.~   "
50052|NCT02401945|"~     The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT)~     administration of DE-120 in subjects with treatment-naive active subfoveal choroidal~     neovascularization (CNV) secondary to age-related macular degeneration (AMD).~   "
50053|NCT02401932|"~     Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.~   "
50067|NCT02401750|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3~     study to evaluate the efficacy and safety of the administration of multiple doses of~     Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus~     Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal~     first metatarsal bunionectomy with osteotomy and internal fixation.~   "
50068|NCT02401737|"~     This Phase 1b trial will assess the dose-related safety and PK profile of different doses of~     NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV~     DNA levels and other virologic efficacy parameters will be assessed.~   "
50054|NCT02401919|"~     COMMUNICATION - Feasibility and effectiveness 'Tell-us Cards' in hospital patients~        -  Objective - To investigate the feasibility and effectiveness of 'Tell-us Cards' on~          patient participation in basic care in hospital settings.~        -  Design - Cluster randomised controlled early trial design (Phase 2B, MRC Framework).~          Patients of two surgical and two medical wards (n=140) will be included in this study.~          Before and after the introduction of the intervention, assessments will take place in~          patients and nurses at these wards.~        -  Intervention - The 'Tell-us card' is a tool to elicit patients preferences and needs in~          basic care. Patients are invited to write down their specific questions and concerns.~          The cards are handed out to patients admitted to the hospital (daily). Patients and~          informal caregivers are invited to use the cards to state their preferences. Nurses are~          instructed to use the cards as a tool in their dialogue with the patient in making care~          plans, during ward rounds or for discharge information sessions.~        -  Comparison - Usual care~        -  Primary outcome - Patient perception of participation in care (Individualized Care~          Scale (ICS)~        -  Secondary - Use and content of the 'Tell-us Cards' actions taken by nurses as a~          consequence of what patients 'tell them' by means of the 'Tell-us Cards', Quality from~          the Patients' perspective (QPP), EQ-5D, and CQ satisfaction with communication & care~          in general~   "
50055|NCT02401906|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      The MRI assessment performed routinely in a patient with an orbital mass includes~     morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This~     exploration requires, regardless of the performed research, a contrast agent injection (0.1~     mg / kg weight of Gadobutrol®).~      In this research protocol, during the injection of the contrast agent performed during the~     MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated~     acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition~     will be preceded by two short series for calibration. The post treatment will include~     parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more~     regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being~     the reference. It will also be added a magnetic susceptibility EPI sequence type. All the~     qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in~     susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent~     diffusion coefficient) parameters will be collected.~      The result of the pathological exam of the biopsy or of the surgical specimen, which is the~     gold-standard, will be collected.~   "
50056|NCT02401893|"~     Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI)~     antibodies after influenza vaccination in older adults so the investigators enrolled adults~     ≥50 years.~   "
50057|NCT02401880|"~     The primary aim of this exploratory mechanistic study is to investigate the effects of~     Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.~      This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to~     placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell~     function, as well as several markers of metabolic control.~   "
50058|NCT02401867|"~     The purpose of this study is to assess the acceptability and effectiveness of utilizing~     vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for~     HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections~     (STIs) among sexually active female-to-male (FTM) transgender adults.~   "
50059|NCT02401854|"~     The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial~     fibrillation (AF) among elderly patients with hypertension and at least one other risk~     factor for AF. This will be accomplished by monitoring with a wireless external loop monitor~     for 30 to 60 days.~   "
50060|NCT02401841|"~     It is a observational prospective study. The aim of this study is to compare neostigmine vs~     sugammadex in the resolution of neuro-muscular blockade in great obese patients.~   "
50061|NCT02401828|"~     48-week open label randomized phase IV investigator initiated intervention study. The~     purpose of this study is to evaluate whether HIV-1 suppression can be maintained by DTG~     monotherapy in HIV-1 infected, virologically suppressed patients on cART.~      104 adults fulfilling the in and exclusion criteria and on stable cART will be randomized~     over 2 investigational arms.~      The first arm will contain the direct switch population. This population will switch~     directly from stable cART to Dolutegravir mono-therapy on baseline visit.~      The second arm will contain the delayed-switch population. This group will switch from~     stable cART to Dolutegravir monotherapy 24 weeks after baseline visit.~      The main goal is to investigate if Dolutegravir mono-therapy could be non-inferior to cART~     in virological suppressed HIV-1 infected adults.~      If a interim analysis (performed when 40 patients on dolutegravir monotherapy have passed~     week 12) shows that it is safe to continue the study, an additional 30 patients will be~     included on top of the 104 patients needed for the primary endpoint analysis. In contrast to~     the primary endpoint population, these additional 30 patients will have a CD4 nadir <200 but~     a CD4 >350 at the time of the screening visit. Besides that, these 30 patients will have to~     fulfill all other in and exclusion criteria of the primary endpoint population (specifically~     a viral load never >100.000). These 30 patients are part of a pilot study looking at the~     possibility to broaden the eligible population in a future larger randomized clinical trial.~   "
50062|NCT02401815|"~     The goal of this clinical research study is to learn how PLX9486 may affect cancer cells~     with certain mutations in the KIT gene, specifically in patients with types of advanced~     solid tumors including Gastrointestinal Stromal Tumor (GIST).~      PLX9486 is designed to block KIT gene mutations. These mutations can cause cancer and cancer~     cell growth. By blocking these mutations, the drug may kill the cancer cells with the~     mutation and/or stop the tumor from growing. By combining PLX9486 with PLX3397, the~     investigators hope to block most gene mutations in KIT.~   "
50063|NCT02401802|"~     This trial will compare the efficacy of 2 different sets of dietary recommendations to be~     followed before colon cleansing for colorectal cancer screening colonoscopy.~   "
50064|NCT02401789|"~     The objective of the present study is to evaluate if loss of multiple adjacent teeth will~     cause proportionally greater tissue diminution than the loss of single teeth the possibility~     of counteracting unfavourable ridge modeling after multiple tooth extractions by placing~     implants in the fresh extraction sites soft tissue alterations at implants and adjacent~     teeth~   "
50069|NCT02401724|"~     After a stroke affecting the right side of the brain, many patients are affected by spatial~     neglect: the damage to the brain causes them to ignore the left side of their surroundings.~     At its most extreme they may be unaware that they have a left side, or believe that it is~     moving normally when it is in fact paralysed. In milder cases, people may be unable to~     recognise touch on the left side if their right side is also being touched, or objects in~     their left visual field if something is visible to their right. Neglect alters peoples'~     quality of life profoundly, often renders them more dependent on others to undertake basic~     activities of daily living, and makes effective rehabilitation much more difficult.~      The limited success of current treatment approaches indicates gaps in understanding of the~     underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in~     responding to the left side are a result of an imbalance of activity in those parts of the~     brain responsible for deciding which side to pay attention to. It might therefore be~     possible to help people with neglect by rebalancing the brain either by increasing~     activity in the damaged side, or alternatively by reducing activity in the undamaged side.~     In this pilot study, the investigators will test whether they can help by doing the second~     of these things.~      The investigators propose to conduct a pilot clinical trial to explore whether using~     electric currents to temporarily modify the activity of specific areas of the intact side of~     the brain, influences recovery from neglect, when used either alone, or in combination with~     a training method that has previously appeared promising as a treatment. Brain activity will~     be modified using a technique called transcranial direct current stimulation (tDCS), in~     which small electric currents are applied to the scalp with a wire covered in damp cotton~     pads. This will be done over the specific parts of the brain that are responsible for~     focusing attention to one side.~      The investigators will compare the clinical outcomes of four interventions (1: behavioural,~     2: tDCS, 3: a combination of both and 4: control).~      The investigators hope that these studies will advance their understanding of what~     treatments may help people with neglect, and how they might work.~   "
50070|NCT02401711|"~     The purpose of this study is to compare the effectiveness of two methods, safety curriculum~     in addition to online training alone, for teaching patient safety to surgery residents.~     Despite multiple studies evaluating educational safety curricula, the best methods for~     teaching residents about patient safety is unknown. It is hypothesized that empowering~     surgery residents to actively engage in behaviors to increase patient safety may lead to a~     higher quality perioperative care and communication.~   "
50071|NCT02401698|"~     The past 10 years of research in post stroke patients have shown certain types of~     rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation~     (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring~     brain activity). Recent research suggests that TMS can be used for both prognosis~     (determining future function) and to determine what type of rehabilitation therapy will work~     best after stroke. The purposes of this research study are to: 1) determine changes in~     cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor~     function with changes in cerebellar - motor cortex connections; 3) determine the ability of~     TMS to predict functional outcome after stroke. The primary hypotheses are: 1) functional~     recovery will be correlated with TMS changes (as measure of motor threshold (MT),~     intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials~     (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.~   "
50072|NCT02401685|"~     POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.~      Aim For women with early stage breast cancer and one or two sentinel node macrometastases,~     to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary~     treatment, in terms of axillary recurrence within 5 years.~      Stratification: Institution, Age (<50, ≥50), Breast-conserving surgery (BCS) or mastectomy,~     Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2),~     Intra-operative sentinel assessment using OSNA (yes, no).~      Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus~     axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).~      Sample Size: 1900 participants~      Follow-up: Participants will be followed up for 5 years.~      Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy~     and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy.~     Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant~     therapy alone.~   "
50073|NCT02401672|"~     Cigarette smoking remains a significant public health concern. A magnetic field applied to~     the outside of the skull can produce electrical activity in the brain without significant~     pain or the need for anesthesia. Sessions of magnetic stimulation or superficial stimulation~     that does not reach the brain will be used to determine if magnetic stimulation can reduce~     cue-induced craving and cigarettes consumption in adult nicotine-dependent cigarette~     smokers. This project may lead to a new therapy for smoking cessation.~   "
50074|NCT02401659|"~     Valiosa is a national, multicenter and prospective post market study. The objectives of the~     study are to generate and validate an instrument to evaluate patient and clinician's~     satisfaction with remote monitoring and to create awareness of the importance of remote~     monitoring among patients, physicians and decision makers.~   "
50075|NCT02401646|"~     The aim of this study is to identify the effect of Polygoni Multiflori Radix complex extract~     on memory improvement using Rey-Kim scale for healthy people.~   "
50076|NCT02401633|"~     Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the~     industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is~     a positive predictor of survival. During the last decade, the best form of bystander CPR has~     been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method~     in situations where the bystander has no previous knowledge in CPR, both because its~     believed to be equally efficient but also a simplified form of CPR that could lead to a~     higher incidence of bystander-CPR.~      The purpose of this study is to perform av run-in period with focus on safety and~     feasibility prior to the launch of a larger randomized trial which has a primary end-point~     of survival. This study will compare OHCA with standard CPR (S-CPR; chest compressions and~     rescue breaths in a 30:2 fashion) compared to CO-CPR.~   "
50077|NCT02401620|"~     The purpose of the present study is to assess the measurement properties of a tolerability~     questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated~     will be robust and will assess the patient's tolerability to the treatment. Patients with~     greater tolerability will be more satisfied with their treatment.~   "
50086|NCT02401503|"~     The CLL2-BAG-trial is a prospective, open-label, multicenter phase-II trial to evaluate the~     efficacy and safety of a sequential regimen of a debulking with Bendamustine followed by an~     induction with GA101 (obinutuzumab) and ABT-199 (venetoclax, GDC-0199) followed by ABT-199~     and GA101-maintenance in CLL patients~   "
50087|NCT02401490|"~     To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade~     II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death~     and/ or liver transplantation).~   "
50078|NCT02401607|"~     The Karasek Job Content Questionnaire includes 2 dimensions: the psychological demands at~     work, and the latitude decision. The combination of these two characteristics explains the~     degree of exposure of a worker to stress. Indeed, a worker is under pressure (job-strain)~     when workload is important and autonomy is poor. The Sumer study was conducted in France on~     25,000 employees and classified occupations taking into account psychological demands and~     latitude decision of occupations. No publication on emergency physicians' responses to~     Karasek questionnaire is referenced, even though theirs exposures to burnout is known. A~     preliminary study on 19 emergency physicians of the CHU of Clermont-Ferrand illustrates~     concretely this extraordinary situation, with the lowest decision latitude and the highest~     psychological demands ever recorded. Moreover, there are no data on results at the Karasek~     questionnaire under different conditions within the same participant, i.e. responses to the~     Karasek questionnaire is supposed similar and reflect a constant perception of work.~     Additionally, several biomarkers of stress have been proposed, in particular DHEAS due to~     its long half-life of 16 hours. To our knowledge, the relationship between biomarkers of~     stress and tension at work with Karasek model has never been studied, like this relations~     with other wellness questionnaires. Comparisons between emergency health care workers are~     also lacking.~      Our study proposes to evaluate the perception of emergency medicine with Karasek~     questionnaire, and to assess possible changes of its perception and in biological response~     between two conditions: after a night shift and on a control day (workday), in emergency~     health care workers.~   "
50079|NCT02401594|"~     PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind~     non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000~     UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material~     removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic~     surgeries for femoral neck and trochanteric fractures, THR, TKR)~      Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24~     hours. However, only a single pre-randomization dose of LMWH is allowed. After~     randomization, patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg~     once-daily started 6-10 hours provided haemostasis has been established after surgery or 24h~     hours after LMWH injection if needed for the intended treatment duration of 2 to 12 weeks~     based on medical judgment (according to immobilization). Patients allocated to the~     comparator arm will receive enoxaparin once daily for the same intended treatment duration.~     All patients will have a 30-day observational period after cessation of treatment.~   "
50080|NCT02401581|"~     Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract~     of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to~     reduce the risk of hemorrhage known to be associated to the transurethral resection of~     prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the~     GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce~     the length of catheterization to facilitate outpatient surgical management of prostate~     adenoma.~      In the investigators study, the investigators propose to evaluate the failure rate of an~     early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS~     in selected patients on general anesthesia or spinal anesthesia. To this end, the~     investigators realize a national multicenter prospective study including 300 patients. The~     effectiveness of this model of management is defined by absence of a need for~     re-catheterization in the post -operative period of 24 hours.~   "
50081|NCT02401568|"~     Compare various dynamic biomechanical markers (distances and angles) in the wrist during~     dynamic CT studies in three groups of patients: Normal subjects, with scapholunate~     instability and with other types of wrist instability.~   "
50082|NCT02401555|"~     The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2~     Supplemental Assay, a single-use immunochromatographic assay for the confirmation and~     differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2~     (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples~     (EDTA, heparin, and sodium citrate).~   "
50083|NCT02401542|"~     This is a phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group~     study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment of locally~     advanced or metastatic urothelial cell carcinoma in subjects who have relapsed after, or are~     refractory to standard therapy.~   "
50084|NCT02401529|"~     This study aims to evaluate the effect of postoperative systemic rapid onset and short~     acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy~     morbidities. Half of the patients who comply with the inclusion criteria were selected to~     receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;~     the second group received placebo.~   "
50085|NCT02401516|"~     ASH has a high prevalence rates and considered one of the major modifiable risk factors for~     cardiac vascular diseases (CVD) and brain vascular diseases (BVD) and one of the most~     important public health problems. Researches estimated 62% of BVD can be attributed to ASH.~     In Brazil, prevalence of hypertension ranged from 21.6% in 2006 to 42.4% in 2011. CVD are~     responsible for high frequency of hospitalization, and in 2009, 91,970 hospitalizations due~     to CVD cost public treasury more than 165 million reais. ASH neurological pathophysiology~     studies has shown that excessive activation of sympathetic autonomic nervous system (SANS)~     seems to have an important role in genesis and maintenance of ASH, with current studies~     aimed to understand this relationship.~      Pathways used by SANS for immediate control of BP (wich are reticulate formation, bulb and~     cortex) appear to be similar to pathways used for postural control reflex (reticulate~     formation, bulb, cortex, among others), which are also used by Postural Reprogramming~     Insoles (PRI) for posture adequacy. Due to this similarity in reflex activation areas, it is~     believed that PRI may have some effect on BP regulation.~      There are many ways to treat postural changes and one of them is posturology, which is based~     on therapeutic use of postural reprogramming insoles (PRI). PRI activates tonic-postural~     system, rebalancing muscles, joints and bony structures of body segments, and returning~     individual to an appropriate posture.~      The PRI is composed of a central artifact, situated in reflex zone full of somatosensory~     stimuli captors, which generates a frequency of vibration that promotes postural adaptation.~   "
50088|NCT02401477|"~     This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID~     and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.~   "
50090|NCT02401451|"~     The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the~     potential to improve the diagnostic yield of arrhythmias, whilst improving the patient~     experience.~      The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the~     patient to undress.~      The aim of the study is to assess the ability of the device to diagnose cardiac rhythms.~      Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as~     the standard 12-lead ECG.~      The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to~     each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device.~      Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and~     diagnosis of arrhythmias. Additionally, as calls for a national screening programme to~     detect atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the~     RhythmPad has the potential to revolutionise how we screen our patients.~   "
50091|NCT02401438|"~     5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery~     to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D~     ultrasound will be compared to the actual birth weight to determine accuracy of 5D~     ultrasound in predicting actual birth weight .~   "
50092|NCT02401425|"~     The purpose of this study is to compare the success rate of letrozole and misoprostol versus~     misoprostol alone for medical termination of first trimester pregnancy.~   "
50093|NCT02401412|"~     Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin~     barrier that is designed to maintain adhesive properties and good peristomal skin health~     compared to other currently marketed barriers.~   "
50094|NCT02401399|"~     Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular~     diet , preoperative balanced energy high protein formula and Immunonutrition~     formula.Postoperative pain and acute phase reactants at 24hours after surgery are~     investigated.~   "
50095|NCT02401386|"~     This trial aims to evaluate the effectiveness of Lu Eight Brocades(LEB) on improving quality~     of life in patients with fibromyalgia (FM). Sixty patients with fibromyalgia will be~     enrolled, and will be randomized into 2 groups with a ratio of 1:1 in this study. Thirty~     participants in LEB group will be asked to learn and practice LEB 30 minutes daily for~     12-weeks; while the other 30 participants will be on a waiting list through 12-weeks. Seven~     questionnaires will be measured at baseline, 4 weeks, 8 weeks and 12 weeks (end of study),~     and a more 12-weeks follow-up.~   "
50096|NCT02401373|"~     This is a single center, open, dose-escalation phase 1 clinical trial. This study will~     determine the safety and side-effect profile, and immunogenicity of an investigational~     Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.~   "
50097|NCT02401360|"~     This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed~     toothpaste and manual toothbrush.~   "
50098|NCT02401347|"~     The aim of this single-arm phase II clinical trial is to evaluate the anti-cancer activity~     of Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific~     genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative~     breast cancer are eligible.~   "
50099|NCT02401334|"~     This prospective clinical study will evaluate the safety and efficacy of the Cook®~     Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue~     during ventral or incisional hernia repair in clean-contaminated, contaminated, and~     dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients~     will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be~     followed for 12 months.~   "
50100|NCT02401321|"~     This pilot clinical trial studies the Taking Care of Her program in patients with stage III~     or IV ovarian cancer and spouse caregivers. This counseling program may equip the spouse~     caregiver with skills to support and nurture the patient through initial diagnosis and~     treatment. It may also help patients and spouse caregivers improve communication and coping~     skills.~   "
50101|NCT02401308|"~     The purpose of the proposed study is to demonstrate that the functional outcomes of DBS~     surgery utilizing the asleep technique are not inferior to those reported for traditional~     awake DBS technique.~   "
50102|NCT02401295|"~     The purpose of this study is to evaluate the safety and tolerability associated with the~     combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous~     stem cell transplant in relapsed multiple myeloma patients.~   "
50103|NCT02401282|"~     This study examines the way attention may be linked to temperamental risk for anxiety,~     social behavior and brain processes. The study aims to see if temperamentally at risk youth~     display an attention bias towards threat, and if anxiety symptoms can be reduced through~     attentional bias modification training.~   "
50104|NCT02401269|"~     CVD accounts for 15% of all deaths in Malawi. Both HIV and ART are risk factors for CVD~     through direct toxic and inflammatory cardiovascular effects. (44,45). At the moment, one~     out of every 10 Malawian is HIV positive and roughly 8 out of 10 of those infected are now~     on ART (2). Therefore, HIV and ART may be contributing to the burden of CVD in Malawi.~     Currently, there are only a few studies assessing CVD risk in the HIV patient population on~     ART. In Malawi, no such studies exist. Therefore, the investigators propose a novel study~     assessing baseline cardiovascular disease risk using two novel ultrasound technologies in~     HIV patients on ART. Cardiovascular disease risk will be assessed using surrogate~     cardiovascular markers of disease. These surrogates include markers of endothelial function~     and cardiovascular modulating inflammatory biomarkers. The inflammatory biomarkers measured~     will be TNF-alpha, IL-6, and CRP. Aspirin, by way of its antiplatelet and anti-inflammatory~     effect has been demonstrated to inhibit atherosclerosis by way of decreasing TNF-alpha,~     IL-6, CRP and improving endothelial function. Therefore a second aim of the study will be to~     demonstrate that aspirin improves surrogate markers of atherosclerosis.~   "
50138|NCT02400827|"~     For prepubertal patients, cryopreservation of ovarian tissue is the only option available to~     preserve their fertility before cancer treatment. But ovarian autograft raises the issue of~     the risk of reintroduction of potentially malignant cells. The aim of our study is to~     develop a specific and sensitive method for residual disease detection in the ovarian tissue~     from patients treated for a solid tumor during infancy, whose fertility may have been~     compromised by treatments and who benefited of ovarian tissue cryopreservation.~   "
50105|NCT02401256|"~     The CYP2B6 enzyme metabolizes a growing number of clinically important drugs such as the~     anti-HIV drug efavirenz, but its activity in the liver is highly variable, which may lead to~     failure of therapy or toxicity and unpredictable drug interactions. Genetic and several~     nongenetic factors affect the activity of CYP2B6. The goal of this study is to determine the~     impact of simultaneous autoinhibition/autoinduction and CYP2B6 genetics on CYP2B6 activity,~     efavirenz exposure and efavirenz-mediated drug interactions. The pharmacokinetics and drug~     interactions will be determined on three occasions in a total of 60 healthy volunteers. The~     whole study will have 4 phases. A) Phase 1 (baseline control): using selective probe~     substrates, the baseline activities of CYP2B6 (bupropion), CYP2C8 (montelukast) and OATP1B1~     (rosuvastatin) are determined. B) Phase 2 (inhibition): the metabolism and pharmacokinetics~     of a single 600 mg oral dose of efavirenz) and the activities of CYP2B6, CYP2C8 and OATP1B1~     (inhibition) are determined. C) Phase 3 (treatment phase): After completing phase 2,~     subjects take 600 mg/day efavirenz at home for 17 days. C) Phase 4 (induction and~     inhibition): At the end of phase 3, steady state metabolism and pharmacokinetics of~     efavirenz and the activities of CYP2B6, CYP2C8 and OATP1B1 will be determined. Efavirenz~     serves as a model substrate, inhibitor and inducer of CYP2B6 (and other drug disposition~     proteins). Bupropion 4-hydroxylation is an alternative in vivo probe of CYP2B6 activity and~     will be studied here in addition to the metabolism and pharmacokinetics of efavirenz.~   "
50106|NCT02401243|"~     Primary Objective:~      The primary objective of this study is to obtain efficacy and safety descriptive data on 2~     different titration algorithms: the INSIGHT titration algorithm (self-titration of 1~     unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as~     basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with~     or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.~      Secondary Objective:~      The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin~     [A1C], fasting plasma glucose [FPG], 7-point self-measure plasma glucose [SMPG], insulin~     dose and weight) and determine patient related outcome and health care professional~     satisfaction as it pertains to each titration regimen.~   "
50107|NCT02401230|"~     The purpose of this study is to determine whether the use of rectal lubricants can affect~     how well the medication, Truvada, will work to prevent infection with HIV when someone is~     exposed to HIV in the rectum.~   "
50108|NCT02401217|"~     The primary objective of this study is to assess the comparative gastrointestinal tolerance~     of normal term infants to two experimental milk-based powdered formulas compared with a~     standard milk-based powdered formula.~   "
50109|NCT02401204|"~     Infections with multiply antibiotic-resistant bacteria represent a major cause of~     preventable morbidity and mortality amongst hospitalized neonates worldwide. In Southeast~     Asia, where antibiotic-resistance is a major problem, Gram-negative bacteria account for the~     majority of such infections. The most common pathogens are Acinetobacter spp., Pseudomonas~     aeruginosa, Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority~     of infections with these pathogens represent asymptomatic carriage, though in the absence of~     routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of~     transmission between patients, and rates of importation from the community are lacking.~     Moreover, current understanding of the degree and manner in which different antibiotics act~     to select for such resistant organisms is rudimentary.~   "
50110|NCT02401191|"~     Primary Objective:~      To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10)~     combination tablet in patients with allergic rhinitis.~      Secondary Objective:~      To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal~     symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.~   "
50111|NCT02401178|"~     The incidence of atopic dermatitis has increased dramatically in this years. Atopic~     dermatitis occurs due to complex interactions between genetic and environmental factors. One~     of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene).~     Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which~     serves to form protein-lipid, thereby disrupting the skin permeability to water and outside~     particles such as allergens.8-14 Several attempts have been made to prevent the occurences~     and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and~     meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life~     gives more consistent and protective results. In this study investigators would like to know~     about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the~     composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to~     see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from~     buccal swab in early life and at the time AD occurs, to know about the diet at the time of~     AD occurrence, and to know the role of the ratio of DHA towards AA level in the development~     of AD due to their antagonistic effects, and to see the interactions between FLG gene, FADS~     gene and LCPUFA level in the development of AD.~   "
50112|NCT02401165|"~     GADD34 is an inducible cofactor of protein phosphatase 1, which has an important role in the~     Unfolded Protein Response (UPR). UPR is a cellular response to ER stress which is implicated~     in several autoimmune diseases. GADD34 has been shown to be necessary for proinflammatory~     cytokine production in response to viral infection in murine models. Nevertheless, the role~     of GADD34 in cytokine production in humans remains to be elucidated. Here, we investigate~     the interest of GADD34 in rheumatoid arthritis (RA), in which proinflammatory cytokines have~     an important pathogenic role.~      A case-control study on GADD34 gene expression in PBMC of patients (n=75) with RA and age-~     and sex-matched healthy controls (n=25). GADD34 gene expression levels in PBMC were measured~     by quantitative PCR.~   "
50148|NCT02400697|"~     The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the~     World Health Organization have recently published recommendations related to placental~     transfusions in preterm infants. This project will review outcomes of preterm infants~     following a quality improvement implementation process in several delivery centers in~     Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford~     Network (IRB#1003-84). Data is recorded for that network and the investigators site will be~     reviewing that data every 3 months from infants who have completed the Vermont Oxford~     Network collection. This project will specifically look at the incidence of intraventricular~     hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death~     following the implementation of the ACOG recommendations.~   "
50113|NCT02401152|"~     The objective of this study is to investigate whether two newly developed sports drink will~     affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control~     drink both in a short and longer distance run. Furthermore, the effect of the newly~     developed sports drinks on gastric emptying will be investigated.~      The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the~     short distance run and the effects on GD and RP. Secondly, a parallel design is used to~     study the effects of the drinks on GD and RP during a longer distance run. Thirdly, the~     gastric emptying tests will be performed in a randomized cross-over design. Participants~     will be asked to fill in questionnaire on the gastric distress they experience. 40~     participants will be enrolled to participate in part 1 and part 2. 10 out of 40 will~     participate in part 3 of the study.~   "
50114|NCT02401139|"~     This study is a Randomized Controlled Trial, investigating the safety and efficacy of~     administration of ketamine as a potential treatment for depression.~   "
50115|NCT02401126|"~     The main purpose of this study is to determine whether dietary nitrate supplementation via~     concentrated beetroot juice improves central and peripheral cardiovascular control and~     physical capacity in patients with systolic heart failure.~   "
50116|NCT02401113|"~     This randomized, placebo-controlled, double-blind study was designed to investigate the~     efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function~     improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per~     day or a placebo for 12 weeks.~   "
50117|NCT02401100|"~     The purpose of this study is to determine whether reduced rectal blood flow is associated~     with the extent of surgery when performing an operation to remove rectal cancer. The~     investigators also aim to describe any relation of reduced rectal blood flow, as well as~     raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic~     leakage. The patients will be recruited at Umeå University Hospital and all patients who are~     planned to undergo anterior resection for rectal cancer and able to consent are eligible for~     this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology~     using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as~     postoperative drain fluid collection will take place. Perianastomotic tissue will also be~     collected. In the postoperative period, any occurrence of surgical complications especially~     anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation~     to type of mesorectal excision (total or partial) and correlated to anastomotic leakage.~     Standard statistical tools will be utilized, such as parametric, non-parametric tests and~     logistic regression, as appropriate. The study will recruit approximately 90 patients during~     three consecutive years.~   "
50118|NCT02401087|"~     The aim of this observational study was to evaluate, based on the intraoperative anesthetic~     that is routinely carried out at the Department of Day Surgery, the difference in timing of~     the patient's discharge from the hospital (ie when the patient has autonomous demabulation~     and urination spontaneous) in patients undergoing correction of varicocele according Marmar.~   "
50119|NCT02401074|"~     Airway irritation, cough and bronchial spasm are common symptoms in patients with airway~     inflammatory diseases such as asthma. The primary focus of this exploratory study is to~     determine if there is an increase in tissue temperature in airway mucosa during asthma~     exacerbation. The results of this study will bring a better understanding of the potential~     involvement of an increase in airway mucosa temperature in the pathogenesis of various~     symptoms in these patients. The finding should help to advance the development of new~     therapeutic strategies for these debilitating diseases.~   "
50120|NCT02401061|"~     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may~     lead to improved platelet levels where these are decreased due to immunological pathologies~     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been~     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The~     primary objective of the study is to assess the efficacy of PRTX-100 in terms of platelet~     response in patients with chronic/persistent ITP.~   "
50121|NCT02401048|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of the~     combination treatment of ibrutinib and MEDI4736 in patients with relapsed or refractory~     lymphomas.~   "
50122|NCT02401035|"~     The purpose of this study is to characterize the pharmacokinetics (PK) and safety of~     intravenous (iv) pantoprazole in patients 1 to 16 years old who are candidates for acid~     suppression therapy.~   "
50123|NCT02401022|"~     To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.~   "
50124|NCT02401009|"~     The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness~     of hematopoietic cell (HC) transplantation for both donors and recipients.~   "
50125|NCT02400996|"~     A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.~   "
50126|NCT02400983|"~     The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm~     algorithm in the automatic management of atrial capture.~   "
50127|NCT02400970|"~     For prepubertal patients, cryopreservation of testicular tissue is the only option available~     to preserve their fertility before cancer treatment. But testicular autograft raises the~     issue of the risk of reintroduction of potentially malignant cells. The aim of our study is~     to develop a specific and sensitive method for residual disease detection in the testicular~     tissue from patients treated for a solid tumor during infancy, whose fertility may have been~     compromised by treatments and who benefited of testicular tissue cryopreservation.~   "
50128|NCT02400957|"~     Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic~     Transbond XT in preventing enamel demineralization adjacent to brackets.~   "
50129|NCT02400944|"~     The purpose of this study is to learn how different lifestyle factors, such as cigarette~     smoking and body weight, change after a diagnosis of bladder cancer, and how they influence~     who gets a bladder cancer recurrence and who does not.~   "
50273|NCT02399072|"~     This study seeks to better characterize relationships between visual function and the~     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration~     (AMD). The study also will generate new information on the relationship between genetics and~     GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling~     patients with GA secondary to AMD. The study visits are scheduled to occur every 6 months.~     The anticipated duration of the study is up to 60 months.~   "
50130|NCT02400931|"~     The mask ventilation is a necessary procedure to provide oxygenation before the tracheal~     intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex,~     which is recently introduced, enables the use of high-dose muscle relaxant without~     concerning the delayed recovery of neuromuscular blockade. It seems that there is no need to~     perform the mask ventilation in adults with normal airway if the investigators use high-dose~     muscle relaxant for the anesthetic induction because adequate muscle relaxation can be~     achieved within 1-2 minutes. Therefore, the investigators hypothesized that routine mask~     ventilation is not needed in adult patients with normal airway. The investigators will~     compare the incidence of desaturation and gastric insufflation between the patients with~     mask ventilation and the patients without mask ventilation.~   "
50131|NCT02400918|"~     Social anxiety disorder (SAD) is the most common anxiety disorder, affecting up to 10% of~     the population and causing significant distress. Fortunately, there are effective~     interventions including cognitive behavior therapy (CBT) and acceptance and commitment~     therapy (ACT). However, only about a third of people with SAD seek treatment. There are a~     number of barriers to seeking treatment, including cost, availability, and stigma. Self-help~     may be one way to reach people who may not otherwise present for treatment. Research on~     self-help books for SAD based on CBT has yielded promising results. However, no research to~     date has examined the efficacy of ACT-based self-help for SAD. The primary purpose of the~     present study is to evaluate The Mindfulness and Acceptance-based Workbook for Social~     Anxiety and Shyness (Fleming & Kocovski, 2013), an ACT-based self-help book. Socially~     anxious participants will be randomly assigned to receive the workbook or be placed on a~     waitlist. It is hypothesized that workbook participants will report significantly reduced~     social anxiety at the end of eight weeks compared to waitlist participants. The secondary~     purpose is to evaluate how the treatment works. Increases in mindfulness and acceptance have~     been shown to lead to reduced social anxiety. These same variables will be examined in the~     present study. Finally, this research aims to examine variables that can predict who may do~     well in treatment. Given that two-thirds of people who meet criteria for this disorder will~     not seek traditional treatments, it is important to develop and evaluate alternative~     treatments, including those based on self-help.~   "
50132|NCT02400905|"~     To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by~     VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the~     treatment of symptomatic disease of the femoropopliteal artery. It is a prospective,~     single-arm, multicenter clinical trial.~   "
50133|NCT02400892|"~     This study will involve patients who are planned to have hip or knee replacement surgeries.~     They will undergo a Transthoracic Echocardiogram study (an ultrasound of the heart) to look~     for a Patent Foramen Ovale (PFO). A PFO is a hole in the heart that everyone is born with~     and in most cases eventually closes by adulthood. However, it does not always close in all~     people. The investigators will compare the participants as two groups - those with a PFO,~     and those without, and look for differences in delirium in their postoperative stay. This~     will help us look for an association between postoperative delirium and the presence of a~     PFO.~   "
50134|NCT02400879|"~     Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac~     anesthesia, its recovery profile in cognitive function has not been investigated. Authors~     determined postoperative Bispectral index (BIS) score as well as extubation time after~     remifentanil-based propofol-supplemented anesthesia and compared them with those after~     conventional balanced sevoflurane-sufentanil anesthesia.~      Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary~     bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented~     (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For~     anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil~     (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect~     concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and~     sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS < 60 (< 1.5 MAC) in~     Group C, respectively.~      Authors will analyze postoperative recovery of cognitive function by using BIS after the use~     of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare~     them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.~   "
50135|NCT02400866|"~     This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of~     chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic~     chemotherapy by a randomized, double-blind, placebo-controlled trial.~   "
50136|NCT02400853|"~     The most frequent complications in premature infants are neurological complications:~     intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of~     severe intraventricular hemorrhages remains stable. Severe hemorrhages are associated with~     neurological sequelae.~      A recent study in humans and in animals shows the role of the complex formed by plasminogen~     activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via~     stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex~     t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced~     by t-PA is associated with the vascular embrittlement. Among the few genetic factors~     associated with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of~     endothelial NO synthase.~      The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high~     risk of intracranial hemorrhage in preterm infants and provide predictive of their~     occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of~     PAI-1 gene and eNOS could separately or associated with the main criterion to identify~     predictive of hemorrhages.~      The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of~     preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage~     coming in the first days of life.~      The secondary objectives are~        -  Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC~        -  Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the~          PAI-1 gene and -922 (A / G) of the eNOS gene.~           120 preterm infants will be included before 30 weeks of gestation with precise~          inclusion and exclusion criteria during a period of 3 years.~      Patients will be divided into two groups according to whether they will or not showed~     intracranial hemorrhage (detected by ultrasound J5-J7).~      The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison~     between the two groups will be carried out using statistical tests. Comparison of the~     presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two~     groups will be performed.~      The demonstration of this hypothesis would permit to identify children from birth in whom~     the immediate implementation of preventive treatment of bleeding is desirable.~   "
50137|NCT02400840|"~     Acute heart allograft rejection is a common complication after orthotopic heart~     transplantation. Primary objective of this study is to assess cardiac MRI as a tool for~     acute heart graft rejection screening, by detecting changes in myocardium structure~     especially extracellular volume.~   "
50274|NCT02399059|"~     Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI~     leads to an immunocompromised situation, leaving unattended the neoplasm. It has been~     described that SSI may result in a worse oncologic outcome.~   "
50139|NCT02400814|"~     This pilot phase I trial compares administration schedules of anti-programmed cell death-1~     ligand 1 (PD-L1) monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in~     treating patients with stage IV non-small cell lung cancer. Monoclonal antibodies, such as~     anti-PD-L1 monoclonal antibody MPDL3280A, may block tumor growth in different ways by~     targeting certain cells. Stereotactic ablative radiotherapy, also known as stereotactic body~     radiation therapy, is a specialized radiation therapy that delivers a single, high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to~     normal tissue. Giving anti-PD-L1 monoclonal antibody MPDL3280A with stereotactic ablative~     radiotherapy may be a better treatment for non-small cell lung cancer. However, it is not~     yet known what the best administration schedule is for these treatments.~   "
50140|NCT02400801|"~     Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in~     postoperative endometriosis patients? (A single centre randomised controlled trial)~   "
50141|NCT02400788|"~     The purpose of this study is to assess efficacy and safety in combination of resminostat and~     sorafenib in Asian patients with advanced HCC previously untreated with systemic~     chemotherapy.~   "
50142|NCT02400775|"~     The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32~     weeks on coronary artery plaque in essential hypertensive patients with stable angina and~     dyslipidemia.~   "
50143|NCT02400762|"~     The purpose of this study is to collect on-label safety and efficacy data where InQu Bone~     Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior~     lumbar interbody fusion (PLIF).~      It is expected that this study will contribute to the compilation of clinical data required~     to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in~     patients who undergo PLIF or TLIF surgery. The results of this study will lead to further~     analysis (i.e. comparison to historical data of other marketed bone graft products, as well~     as, to local bone alone).~   "
50144|NCT02400749|"~     This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects~     with moderate to severe plaque psoriasis involving palms and/or soles.~      Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared~     against placebo (dummy drug with no active ingredient).~      This study will enroll approximately 100 adult subjects with moderate to severe plaque~     psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be~     eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles,~     with lesions covering at least 10% of the surface of palms and soles at the baseline visit.~     Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning~     that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the~     first 16 weeks. Subjects will not know which of the two treatments they receive. The study~     doctor, the study staff will not know which treatment they receive either. All subjects will~     receive Apremilast from Week 16 to Week 32.~      Subjects will be asked to complete questionnaires about their hand and feet pain, their~     quality of life, their general health and the impact of psoriasis on their work.~      Medical photographs of palms and soles will be taken for subjects at selected study sites~     only.~      At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies~     can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or~     certain cellular messengers that can be quantified. It is also possible to study the skin~     cellular structure and organization.~      A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms~     or soles and one biopsy from normal skin of palms or soles will be collected. At Week 16~     visit, only one biopsy from psoriasis on palms or soles will be collected.~   "
50145|NCT02400736|"~     In response to the Rehabilitation Research and Development (RR&D) Deployment Health~     Research, this study addresses the delivery of an evidenced-based vocational rehabilitation,~     specifically Individual Placement and Support (IPS), for Veterans who often face~     unemployment and mental illness as they try to recovery from illness and re-establish~     civilian life. This study provides the requisite evidence needed to guide VHA as to whether~     to expand the target population for IPS to all Veterans with a mental disorder, delivered~     directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such~     modifications in VHA practice could substantially improve Veteran vocational rehabilitation~     access and outcomes, moving a significantly greater number of disabled Veterans back to full~     and productive lives in the community.~   "
50146|NCT02400723|"~     Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement,~     functional decline, and disability in older patients. This study will compare two~     self-directed treatments delivered via DVD videos that can be viewed in one's own home. The~     two treatments being compared are: psychoeducation, which refers to information and~     education about anxiety, and a behavioral treatment program, called BREATHE (Breathing,~     Relaxation and Education for Anxiety Treatment in the Home Environment). BREATHE teaches~     diaphragmatic breathing and progressive muscle relaxation. Participants will be randomly~     assigned to either treatment. The study is 12 weeks long. There are 4 weeks of treatment via~     DVD and 8 weeks of follow-up. Participants will be asked questions about anxiety symptoms,~     mood, health and functioning.~   "
50147|NCT02400710|"~     PTSD Coach is a mobile application (app) that aims to teach individuals self-management~     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use~     of evidence-based cognitive behavioral strategies there is still a need to test the~     effectiveness of the app in managing PTSD symptoms. There is research evidence that~     self-management programs are often underutilized, but that clinician contact can increase~     patient involvement. The addition of clinician support may enhance the utilization and~     effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder~     interviews with primary care (PC) and mental health (MH) leadership staff to investigate~     barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase~     the uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the~     development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2~     the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans~     with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive~     Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1)~     investigate the feasibility of recruiting and retaining participants and delivering the SM~     and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS.~     The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes~     will be generated for the following outcomes: a) reductions in PTSD, depression, and general~     distress, and increases in health-related functioning, b) increases in knowledge about PTSD~     symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in~     initiation of tradition PTSD treatments.~   "
50275|NCT02399046|"~     A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.~   "
50380|NCT02397681|"~     The purpose of this study is to determine the effects of procedural differences during the~     Valsalva maneuver and deep breathing test in autonomic nervous system testing.~   "
50149|NCT02400684|"~     Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be~     ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according~     to severity, and the stage is established on the basis of intra-operative observations. The~     AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most~     associated with endometriosis are subfertility and pelvic pain.~      In the surgical management of deep endometriosis, the issue of fertility is pivotal. There~     is a higher rate of infertility in a population of women with endometriosis as compared to~     the general population, even though the mechanisms are not yet elucidated. Patients with~     deep endometriosis can be referred to the surgeon for subfertility, but even when they are~     referred for chronic pain, future fertility considerations are taken into account in the~     planning of the surgery, as the patients are often young.~      It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian~     reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian~     reserve is the functional potential of the ovaries, reflecting the quantity and quality of~     remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian~     hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently~     the most reliable marker to assess ovarian reserve. A significant difference was found~     between AMH before and following cystectomy in several studies. The deleterious effect of~     deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis~     in many cases, even when no cystectomy has been performed, is therefore not entirely ruled~     out. To the best of our knowledge, there are no studies on the effect of deep endometriosis~     surgery, apart from ovarian surgery, on ovarian reserve.~      Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with~     more than 200 cases every year. The objective of this trial is to assess the effect of deep~     endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by~     measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.~   "
50150|NCT02400671|"~     The investigators are conducting a 3-arm randomized trial comparing the effects of~     unidirectional SMS (ie: push messaging to participant) vs. bidirectional SMS dialogue~     between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in~     Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.~   "
50151|NCT02400658|"~     The purpose of this study is to evaluate an investigational way to provide radiation therapy~     to treat early-stage breast cancer at the time of surgery.~   "
50152|NCT02400645|"~     In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain~     relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal~     bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in~     patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.~   "
50153|NCT02400632|"~     The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late~     lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary~     Angiography / Intravascular Ultrasound examination for the treatment of coronary artery~     lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.~   "
50154|NCT02400619|"~     Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with~     cerebral palsy, having a significantly effect on their mobility and quality of life. There~     is much controversy about what is the most appropriate treatment of spasticity The objective~     of the present study is to evaluate the effects of radial extracorporeal shock wave therapy~     (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with~     cerebral palsy~      The number needed of patients is 70 (35 per group). Leaving a period of washout between one~     therapy and the other~   "
50155|NCT02400606|"~     The aim of the study was to explore the effect of actively constructing Virtual patient (VP)~     cases compared with solving VP cases using 'Web-SP', Stockholm University, Stockholm, Sweden~     on knowledge gains and skills transfer in a group of pre-clerkship medical students.~   "
50156|NCT02400593|"~     Growing up in a low-income household has been shown to increase risk for, and susceptibility~     to many illnesses.The purpose of the study is to test an affective intervention for~     reversing biological risk factors, as related to childhood adversity, in midlife.~      Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation~     classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys,~     and two 30-minute surveys prior to each lab visit. During the lab visits, participants will~     have their psychophysiology monitored for heart rate, blood pressure, respiration, and~     pulse. Participants will also have their blood drawn.~      All surveys and questionnaires inquire about participants' current demographics, family~     history, perceptions about life and well-being, physical health, and monetary choices.~   "
50157|NCT02400580|"~     The objective of this study is to quantify the change in post-operative pain scores and~     narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to~     placebo in women undergoing laparoscopic hysterectomy.~   "
50158|NCT02400567|"~     The investigators propose in the present study an innovative approach, combining the most~     recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and~     innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response~     evaluation method. In line with the most recent recommendations on targeted anticancer~     therapies, the investigators have designed a parallel phase II randomized trial with early~     stopping rules 26, which will able in the meantime to build a unique prospective collection~     of tumor tissue, pre- and post-treatment.~   "
50159|NCT02400554|"~     This is an obesity and alcohol, tobacco, and other drug (ATOD) use risk prevention and~     health leadership program. This project will include 150 at-risk adult Native women across 5~     communities (30 women from each community) in the Choctaw Nation of Oklahoma. The~     intervention targets individual behavioral change relative to ATOD and obesity prevention~     and simultaneously provides behavioral skills for health promotion leadership.~      Investigators will conduct a longitudinal study using a cluster randomized stepped-wedge~     design to evaluate the intervention impact on ATOD and obesity prevention primary aims of:~     (1) substance use harm reduction and ATOD use and intentions to use; and (2) reduction in~     weight/body mass index (BMI) and increase in leisure-time physical activity/physical~     activity (LTPA/PA) and healthful food habits. Specifically, investigators will ask~     participants to participate in up to eight group sessions (based on a curriculum drawing on~     cultural teachings around health and behavioral change); attend up to three Motivational~     Interviewing individual sessions (to identify individual behavioral change goals); attend a~     two-day overnight culture and Trail prep camp; participate in camping and walking for up to~     10 days on the Trail; and attend up to six post-walk meetings (to develop community health~     events). All five communities will also be asked to complete a baseline health assessment as~     well as three follow up assessments over the course of the year. Additionally, communities~     2-5 will participate in three pre-intervention health assessments. This intervention~     integrates components of motivational interviewing, information-motivation-behavior, and a~     leadership development framework for adults. It targets individual behavioral change~     relative to ATOD and obesity prevention and simultaneously provides behavioral skills for~     health promotion leadership within their respective communities.The project addresses a~     critical public health issue among a group experiencing considerable health disparities and~     strengthens the research infrastructure in partnership with the Tribe. If efficacious, it~     has the potential for widespread dissemination and could be generalizable to other chronic~     co-occurring mental health and physical health conditions.~   "
50160|NCT02400541|"~     The aim of research is to test in a randomized clinical trial with active sessions, the~     efficacy of cognitive remediation therapy in children anorexia nervosa compared to a~     controlled group. The investigators want to confirm the efficacy of cognitive remediation~     treatment in children's flexibility problems.~   "
50161|NCT02400528|"~     The studies conducted so far concerning the medical and paramedical cares provided to~     patients with profound and multiple disabilities (PMD) often show important limitations:~     samples are too small or very heterogeneous, generally constituted of children only; studies~     are mainly cross-sectional and retrospective, focusing on very specific issues instead of~     assessing health and quality of life from a more global perspective… So far, the~     investigators found no published data from a prospective cohort study involving a~     representative sample of patients with PMD. The present project aims to set up such a cohort~     so as to describe for the first time the natural history of French patients with PMD as well~     as the cares they receive at home or within the different dedicated structures in France.~     This cohort will also make it possible to identify the factors responsible for differences~     in the cares patients are provided, the consequences of these differences on their health~     and their quality of life (and those of their relatives) as well as the evolutions of these~     data over time. It will then allow for assessing the effectiveness of the French healthcare~     system to care for patients with PMD as well as building a frame of reference regarding the~     best cares to provide to these patients.~      The primary goal of this study is to identify the determinants of health among patients with~     PMD.~   "
50162|NCT02400515|"~     This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on~     glucose and lipid metabolism as well as the scales of anxiety and depression and levels of~     salivary cortisol in women with type 2 diabetes.~   "
50163|NCT02400502|"~     Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining~     strategies to improve stress reactivity and increase meaningful coping, as well as a range~     of possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal~     measures (e.g. relapse, quality of life).~   "
50164|NCT02400489|"~     To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or~     2800TFX) from three hospitals in China.~      To track the patients'situations during one year after surgery and to collect the relevant~     clinical data.~   "
50165|NCT02400476|"~     An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with~     Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis~   "
50166|NCT02400463|"~     This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic~     syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice~     daily in patients with HPS. The primary endpoint is overall survival at two months.~   "
50167|NCT02400450|"~     This is a multi-site, double-blind, randomized, controlled food intervention study being~     conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in~     Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of~     functional foods on blood glucose and lipids, and blood vessel function in individuals with~     prediabetes.~      A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 & <7.0 and no~     glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a~     12-week clinical trial to determine the effect of eating 2 items containing functional~     ingredients daily compared to 2 similar items lacking the functional ingredients. Study~     foods provided are to be incorporated into participant's usual diet.~   "
50168|NCT02400437|"~     This research study is evaluating a drug called ixazomib (also known as MLN9708) in~     combination with dexamethasone and rituximab (the regimen is called IDR) as a possible~     treatment for Waldenstrom's Macroglobulinemia (WM).~   "
50169|NCT02400424|"~     The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy~     after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma~     (NSCLC) with peripheral primary tumor.~      Evaluate in terms of local control rate at 6 months the addition of stereotactic~     radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal~     non-resectable stage III NSCLC having a peripheral primary tumor.~      The number of patients required in this multicenter prospective study is 70.~      This is a prospective, multicenter, non comparative and non randomized study.~   "
50170|NCT02400411|"~     This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses~     elicited by meals containing either whole grain rye bread or white wheat bread as such or~     combined with margarine and ham and vegetable soup are compared. Blood glucose~     concentrations are monitored from finger prick blood samples collected before the meal and~     at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at~     time-points 0, 30 and 60 min.~   "
50171|NCT02400398|"~     Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia~     defined as greater than 5% unintentional weight loss within 6 months prior to screening~     visit. Patients must be greater than 18 years of age; and have greater than 3 months life~     expectancy.~      This study will observe a standard of care intervention (tube feeding) for potential~     benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and~     dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily~     for the duration of the protocol.~   "
50172|NCT02400385|"~     This will be a phase II trial of the combination of sunitinib and nivolumab in patients with~     advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their~     tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and~     nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.~   "
50195|NCT02400086|"~     Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to~     improve their respiratory function. Bacterial flora and bacterial drug resistance in the~     respiratory tract have never been studied until then for this type of patient in spite of~     their frequent hospital stay, their regular exposition to antibiotics and their~     susceptibility to swallowing disorders due to their pathology. This study is based on a~     single tracheal aspirate within the 48 first hours of the patient stay for a ventilation~     check up beside any infectious context to describe the basal bacterial respiratory flora.~   "
50285|NCT02398916|"~     Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic~     procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The~     procedure usually performed in the outpatient setting under local anesthesia. However, it~     could be associated with significant pain and anxiety.~      The aim of this study is to examine the effects of listening to music during the procedure~     in reducing pain and anxiety.~   "
50173|NCT02400372|"~     The study, Evaluation of the effect of antibacterial medical honey dressing for healing of~     implants donor area, is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment~     groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of~     antibacterial medical honey dressing in the therapy of donor area of implants. In our~     Research Will participate in 135 new patients over the age of 18, with a wound in the donor~     area of hip implants, Hospitalized in the Plastic Surgery Unit of the Haemek Medical~     Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned~     randomly to one of three treatment groups:~        1. The research group: Medihoney antibacterial wound dressing.~        2. The control group: Paraffin gauze with saline- The basic treatment in the donor site,~          accepted the literature.~        3. Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic~          Surgery Unit of the Haemek Medical Center.~      Participants in the three study groups will be performed, each visit, Medical monitoring and~     examination by a team of medical indices of Plastic Surgery Unit, as is customary. The~     treatment will be performed, twice a week until recovery and the complete closure of the~     wound.~   "
50174|NCT02400359|"~     The purpose of this protocol is to investigate, using functional magnetic resonance imaging~     (fMRI), the effect of treatment with lorcaserin on centers of the brain that control~     appetite and food intake, as well as lorcaserin's downstream metabolic effects.~   "
50175|NCT02400346|"~     The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as~     adjunctive treatment in an elderly population with major depressive disorder and an~     inadequate response to antidepressant treatment~   "
50176|NCT02400333|"~     This study will be an open-label, randomised, four-period, four-treatment, crossover study~     in healthy male and female of non-childbearing potential subjects, performed at a single~     study centre.~      The objective of the study is to assess the bioavailability of ticagrelor orodispersible~     (OD) tablets when administered with water, without water and suspended in water to be~     administered through nasogastric tubes, compared to ticagrelor immediate-release (IR)~     tablets~   "
50177|NCT02400320|"~     The purpose of this study is to determine local skin safety of a topical analgesic spray~     containing a combination of diclofenac, methyl salicylate, menthol and compare it with a~     topical analgesic gel containing a combination of diclofenac, methyl salicylate, and~     menthol.~   "
50178|NCT02400307|"~     This study will evaluate the pharmacokinetic (PK) profile, safety, and tolerability of oral~     GS-9883 in adults with impaired renal function relative to matched, healthy controls with~     normal renal function. Each participant in the renal impairment groups will be matched for~     age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a~     participant in the control group.~   "
50179|NCT02400294|"~     Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on~     prevention of ventilator associated pneumonia~   "
50180|NCT02400281|"~     This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with~     standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine,~     FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine~   "
50181|NCT02400268|"~     The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria~     are becoming more and more frequent, and available antimicrobial agents are usually scarce.~     Reducing the duration of antimicrobial treatments is one of the most efficient measures to~     control the antibiotic pressure and to optimise the use of these agents.~      Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal~     duration of antibiotics to treat them is unknown, as long as no clinical trials have been~     specifically developed to answer this question.~      Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the~     bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days.~     This represents a variability of up to 100%. No recommendations have been published~     regarding the duration of treatment of bacteremia from other sources.~      The objective of this project is to prove that the 7-day course of treatment for EB~     bacteremia is more efficient and equally safe than the 14-day scheme.~   "
50182|NCT02400255|"~     This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3~     mutations who have achieved complete remission (CR) after allogeneic stem cell~     transplantation. Oral crenolanib will be administered daily post-transplant for up to two~     years.~   "
50183|NCT02400242|"~     This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to~     determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor~     activity of ACY-241 for oral administration as monotherapy and in combination therapy with~     orally administered pomalidomide and low-dose dexamethasone in eligible patients with~     relapsed or relapsed-and-refractory multiple myeloma (MM).~   "
50184|NCT02400229|"~     The primary hypothesis is that computertomography (CT) is superior to invasive coronary~     angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular~     event; defined as at least one of the following: cardiovascular death, nonfatal myocardial~     infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that~     CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE~     = minor cardiovascular events), procedural complications, cost-effectiveness, radiation~     exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.~   "
50196|NCT02400073|"~     Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of~     suffers. Recent literature has shown that females may be particularly susceptible to adverse~     the quality of life effects, and that female obstructive sleep apnea manifests differently~     than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device~     has been designed specifically to treat female OSA. In this Cohort study, female patients~     who are newly diagnosed with OSA will be asked to complete various questionnaires relating~     to their quality of life. Patients will then use the AutoSet for Her for three months. At~     the completion of the three months the questionnaires will be repeated. Before treatment and~     after treatment quality of life will be compared to determine if treating female specific~     OSA in these patients improves quality of life.~   "
50381|NCT02397668|"~     To demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM~     Tricuspid Valve and increase the efficiency of the device development process by identifying~     appropriate modifications to the implant procedure or the device.~   "
50185|NCT02400216|"~     Background:~      - Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the~     intestines may spread to the liver and blood during liver disease. This is called bacterial~     translocation (BT). Researchers think BT may cause liver disease to worsen.~      Objectives:~      - To study the mechanisms involved in BT in early and advanced liver disease. To find out~     whether BT causes liver disease to worsen.~      Eligibility:~      - People over age 18 with HCV and clinically stable liver disease.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood tests and imaging studies.~        -  Participants will have 2 outpatient visits and a 3-day stay at the clinic.~        -  At visit 1, participants will have urine and blood tests. They will have a magnetic~          resonance imaging (MRI) scan. A solution will be injected into a vein. The MRI scanner~          is a metal cylinder surrounded by a magnetic field. The participant will lie on a table~          that slides in and out of the cylinder.~        -  At visit 2, a substance will be injected into a vein and swallowed. Participants will~          then have blood drawn 5 times over 90 minutes.~        -  During the inpatient stay, serial blood tests will be drawn.~        -  Participants will give 2 stool samples and have another MRI.~        -  A needle will be inserted through the chest wall into a vein inside the liver, guided~          by ultrasound. The blood pressure inside this vein will be measured and blood will be~          drawn from it. About 1 inch of liver tissue will be removed.~        -  A study investigator will call participants to discuss all test results.~   "
50186|NCT02400203|"~     The objectives of this trial are to assess the effects of hemp product consumption,~     specifically hulled hemp seeds and hemp oil on blood fatty acid profiles and cardiovascular~     disease risk factors, in healthy overweight volunteers after 4 weeks of consumption.~   "
50187|NCT02400190|"~     This study will collect rates of local/regional recurrence in select patients who do not~     receive radiation treatment after lumpectomy surgery. These women must be postmenopausal;~     have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal~     to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect~     prospective data supporting the idea that this is a population at sufficiently low risk of~     local/regional recurrence that omission of adjuvant radiation might be a reasonable option.~   "
50188|NCT02400177|"~     The purpose of this study is examine emotional regulation and reflective functioning in~     parents of children with Autism Spectrum Disorders (ASD) before and after an educational~     training (four sessions workshop). Our experimental aims are the following: 1) examine~     parental emotion regulation and reflective functioning in daily life, 2) examine children~     emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents.~     This research study will help to formulate innovative treatment methods to reinforce~     positive emotion regulation of both ASD children and their parents.~   "
50189|NCT02400164|"~     The study is a multi-center, prospective, open label, uncontrolled feasibility study~     enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites.~     Patients will be enrolled during a 6 month enrollment phase after which data will be~     collected for 12months with an initial analysis after 3 months. Extended follow-up for~     safety monitoring purposes will continue for the lifetime of the patient or until the device~     is explanted.~   "
50190|NCT02400151|"~     The main objective of this study is to analyze in a population of obese adolescents, the~     effect of vitamin D3 supplementation in addition to lifestyle and dietary management on~     vascular function assessed by the change between M0 and M3 of endothelium-dependent~     vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).~   "
50191|NCT02400138|"~     Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate~     important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory~     and expiratory muscles is required, mainly when performing physical activities,~     rehabilitation interventions for stroke subjects should include respiratory training. This~     study will test the hypothesis that home-based combined training of the inspiratory and~     expiratory muscles is effective in improving strength and endurance of the inspiratory and~     expiratory muscles, fatigue, exercise capacity, and quality of life with stroke subjects.~     For this clinical trial, people after stroke will be randomly allocated into either~     experimental or control/sham groups. The experimental group will undertake training of the~     inspiratory plus expiratory muscles with the Threshold device regulated at 40% of the~     subjects' maximal inspiratory and expíratory pressure values, five times/week over eight~     weeks during 30 minutes/day. The control group will undertake the same protocol, but the~     participants will receive the threshold devices without the resistance valves. At baseline,~     post intervention, and four and 12 weeks after the cessation of the interventions,~     researchers blinded to group allocations will collect the following outcome measures:~     maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation,~     exercise capacity, and quality of life.~   "
50192|NCT02400125|"~     China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary~     artery bypass grafting (CABG) and valve surgery performed in 87 hospitals with~     cardiovascular surgery volume > 100 per year. The aims of CCSR Study are: (i) report the~     characteristics of patient, the quality and evolvement of CABG and valve procedures in~     China, (ii) build and valid surgical risk assessment tools for Chinese population, (iii)~     provide databases for clinical studies, and quality improvement initiatives.~   "
50193|NCT02400112|"~     The purpose of this study is to determine if local administration of vancomycin powder at~     the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method~     to lower infection rates in open fracture treatment and to elucidate any detrimental effects~     of applying vancomycin powder at the site of open fractures.~   "
50194|NCT02400099|"~     Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is~     more effective than a control low calorie diet in improving the metabolic and histologic~     abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric~     surgery.~   "
50197|NCT02400060|"~     This pilot trial studies a telephone-based intervention to see if it increases adherence to~     adjuvant hormonal therapy in patients with breast cancer. Increasing communication between~     doctors and patients with breast cancer may help patients to better follow recommendations~     on taking adjuvant hormonal treatment medication. A telephone-based intervention may help to~     increase doctor-patient communication and patients' adherence to their prescribed~     medication.~   "
50198|NCT02400047|"~     Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory~     care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in~     intraoperative care is recommended for effective postoperative analgesia in children.~     However, intravenous ketoprofen doesn't have the marketing authorization for use in children~     less than 15 years old and its use is mainly justified by the absence of therapeutic~     alternatives. Recently, findings from published studies suggest that dexamethasone (DXM),~     which is actually recommended to prevent PONV for children at risk, at a dose of 0.1mg/kg,~     would have analgesic properties above 0.15 mg/kg comparable to non-steroidal~     anti-inflammatories (NSAI).~      Main objective :~      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of~     postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).~      Secondary objectives :~      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen~     (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the~     consumption of rescue analgesics and the side effects in the first 24 hours after surgery.~   "
50199|NCT02400034|"~     Urinary incontinence is a prevalent health and quality of life concern affecting almost half~     of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of~     many surgeons who perform midurethral sling surgery. All patients after outpatient~     midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to~     be discharged without a catheter. The purpose of this study is to compare two different~     types of postoperative voiding trials to determine which leads to less post-operative~     issues, such as urinary retention requiring catheterization. You are being asked to~     participate because you are having midurethral sling surgery, either with or without vaginal~     prolapse repair.~   "
50200|NCT02400021|"~     In pregnancy, cART is considered optimal for maternal health and for preventing the~     emergence of resistance that could compromise further care. In Canada, the majority of~     HIV-positive pregnant women receive a PI-based cART regimen. In the past, therapy was~     generally deferred until after the first trimester (if not required for maternal health) to~     minimize any unknown risk of teratogenicity. However, as treatment is now started earlier in~     HIV infection and as perinatal transmission rates are lowest in those with prolonged~     suppression of viral load during pregnancy, women are increasingly commencing cART either~     before conception or earlier in pregnancy.~      Multiple reports and cohort studies provided data suggesting an association between PI-based~     cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies,~     although conflicting data exist.~      In the general population progesterone supplementation is widely used, is well tolerated, is~     considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth~     weight. The investigators experimental findings suggest that PI use during pregnancy is~     associated with declines in progesterone levels that correlate with fetal growth, and that~     progesterone supplementation can improve PI-induced fetal growth restriction. The~     investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated~     with declines in progesterone levels, which correlate with birth weight percentile. Since~     HIV-positive women have higher rates of pre-term delivery and low birth weight that may be~     magnified by the use of PIs, then progesterone supplementation could be of benefit to~     neonatal health in the context of HIV-positive pregnancy.~   "
50201|NCT02400008|"~     Selective laryngeal bilateral reinnervation as a secondary treatment in patients with~     bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids~     ankylosis.~      The surgical procedure is : functional reinnervation with the upper root of one phrenic~     nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory~     muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right~     and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.~      Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid~     abduction, and residual dysphonia, a secondary vocal fold medialization is done by an~     endoscopic approach 12 months after reinnervation (included in the protocol).~      Improvement is expected in voice and breathing, without aspiration.~   "
50202|NCT02399995|"~     This study is being done to learn more about health related quality of life factors in~     people having surgery for colorectal liver metastasis. The investigators will look at how~     these factors may change over time. The information gained from this study will help the~     investigators to understand the long-term effects that cancer treatments have on the health~     related quality of life of patients. This information is of high value and will help doctors~     talk to patients about the possible effects of their operations. While many patients live a~     long time after such operations, the studies that have been done do not tell the full story~     of what patients go through after surgery. This study will help us to understand cancer~     treatment from the patient's perspective. It will also help cancer patients make better~     decisions about their treatment options and will help them know what to expect after the~     operation.~   "
50203|NCT02399982|"~     This study aims to utilize emerging mobile application technology, as a tool for increasing~     the potency, accessibility, and efficacy of a guided self-help version of~     cognitive-behavioral therapy (CBT-GSH) for binge eating. The feasibility and efficacy of the~     adapted smartphone application created by Noom Inc., Noom Monitor, will be examined through~     a randomized control trial comparing CBT-GSH + APP with CBT-GSH conducted at the Mount Sinai~     School of Medicine's Eating and Weight Disorders Program. The investigators hypothesize that~     CBT-GSH with the addition of the Noom Monitor, will be significantly more acceptable, have~     greater uptake of self-monitoring, greater adherence to treatment, and greater reduction in~     objective binge episodes (OBEs) than standard CBT-GSH.~   "
50215|NCT02399826|"~     This is comparison trial comparing human amniotic membrane to standard wound care for non~     healing diabetic foot wounds over a 12 weeks period~   "
50216|NCT02399813|"~     This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations~     of ADXS11-001 in 31 and 24 subjects, respectively with persistent/recurrent, loco-regional~     or metastatic SCCA of the anorectal canal that have received at least 1 regimen for the~     treatment of advanced disease~   "
50286|NCT02398903|"~     The aim of our study is to assess the concentrations of different oral contraceptive agents~     in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve~     gastrectomy) in order to study the role of the surgery and the role of body weight on drug~     concentrations, and to compare these concentrations with those of normal-weight women.~   "
50204|NCT02399969|"~     The purpose of this study is to study acupuncture for the treatment of low back pain in the~     emergency department. Current treatments for low back pain in the emergency department~     generally include pills or injections of medications to treat pain and relax muscles.~     However, it is known that many of these medications have risks and toxicities which may~     limit their safe use in some patients. Therefore, new types of treatments are needed.~      Acupuncture is an ancient form of healing that has been practiced in some form for~     centuries. In modern times, acupuncture has been studied for the long-term treatment of low~     back pain and some research suggests it may be effective. However, very little research has~     examined the use of acupuncture for immediate pain relief in the emergency department.~      This research will study a type of acupuncture called Battlefield Acupuncture (BFA).~     Battlefield acupuncture was designed by a physician in the US military with the purpose of~     providing immediate pain relief. It involves the placement of 5 small needles in each ear.~     The needles may be removed at any time. The hypothesis of this study is that battlefield~     acupuncture may improve mobility and pain of patients with low back pain in the emergency~     department.~   "
50205|NCT02399956|"~     While the majority of women in the general population can breastfeed successfully, the~     investigators have limited knowledge about the correlates and sequelae of lactation success~     among women treated for pediatric malignancies. Childhood cancer treatments are known to~     cause late effects that frequently involve the endocrine system. Because normal lactation is~     dependent upon interplay of multiple endocrine factors, the investigators anticipate more~     breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies,~     thyroid disorders and obesity. In order to more fully inform clinicians and female~     survivors, the study of the burden of lactation failure is needed to begin to address the~     impact of pediatric cancer therapy on lactation success/failure and to examine the~     association of specific endocrine disorders on lactation outcomes.~   "
50206|NCT02399943|"~     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see~     how useful the combination of two drugs, panitumumab and trametinib, are in patients with~     advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).~      Panitumumab is a drug that is approved by Health Canada for the treatment of advanced~     colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the~     protein, epidermal growth factor receptor (EGFR) from working.~      Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a~     mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated~     protein kinase kinase (MEK) 1 and MEK2 from working.~      Previous studies have shown that the combination of panitumumab and trametinib may be more~     useful in KRAS, NRAS, or BRAF wild type colorectal cancer.~   "
50207|NCT02399930|"~     Currently, breathing rate and heart rate are checked by nursing staff manually every few~     hours and entered into a patient's medical record. The investigators are doing this study to~     see if a device that will automatically record breathing rate and heart rate every 15~     minutes is as accurate as the manual measurement. The investigators will also see if these~     measurements, taken every 15 minutes, will help us predict adverse events more quickly and~     accurately than the measurements taken every few hours.~   "
50208|NCT02399917|"~     The goal of this clinical research study is to find the highest tolerated dose of the~     combination of lirilumab and 5-azacytidine that can be given to patients with AML or~     high-risk MDS. Researchers also want to learn if the drug combination can help to control~     the disease. The safety of the drug combination will also be studied.~   "
50209|NCT02399904|"~     This study was conducted to check the effect of California tri-pull taping method on post~     stroke shoulder subluxation, prior to conduct a large randomized clinical trial this study~     was conducted, and the result of the study was promising for the treatment of shoulder~     subluxation.~   "
50210|NCT02399891|"~     Cohort study aimed at evaluating the incidence of left ventricular (LV) dysfunction after~     myocardial infraction (MI) and assessing the prognostic utility of change in ejection~     fraction (EF) over the initial 12 months after MI.~   "
50211|NCT02399878|"~     Respiratory complications represent the second most frequent type of postoperative~     complications with an incidence estimated to range from 2.0% to 7.9%~      It has been shown that intra-operative protective ventilation is associated with a reduced~     risk of respiratory complications. The effects of intra-operative inspiratory oxygen~     fraction (FiO2) remain to be investigated.~      In this study, the investigators aim to investigate the association between intra-operative~     FiO2 and respiratory complication as well as surgical site infection and ICU admission in~     patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that~     high intra-operative FiO2 increases the risk of postoperative respiratory complications~     independent of predefined risk factors.~   "
50212|NCT02399865|"~     Research evidence shows that there is a high prevalence of substance use among young people~     in the UK. Early onset and high levels of use are associated with a range of negative~     outcomes, including increased risk of later problematic use and dependence. A growing body~     of research has identified family interventions to be effective in treating young people's~     substance use problems. However, despite this evidence, takeup of family based approaches,~     at least in the UK, has been low. A key factor appears to be the resource intensive nature~     of many family interventions, making them difficult to implement and deliver in many service~     settings, especially in the context of substantial cuts to drug and alcohol services for~     young people (1). Another potential barrier may be the cultural adaptation of approaches~     developed in the USA to a UK setting. There is growing awareness of the need to adapt~     evidence-based treatments to different cultural groups and settings in order to ensure~     successful implementation (2,3,4).~      Following on from developmental and adaptation work, this study aims to demonstrate the~     feasibility of recruiting young people to specifically developed family and network based~     intervention. In addition the feasibility of training staff from existing young people~     addiction services to deliver this intervention will be explored and treatment retention~     will be assessed. Qualitative interviews will elicit the participants' views on the~     acceptability of the intervention and their experiences of both it and the study process.~   "
50213|NCT02399852|"~     Study to assess changes in carotid and aortic atherosclerosis in patients being treated with~     lomitapide.~   "
50214|NCT02399839|"~     To evaluate the outcomes of pregnancy in women treated with lomitapide.~   "
50217|NCT02399800|"~     Rationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which~     results in debilitating abdominal pain, decreased productivity and increased health care~     costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to~     treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic~     cancer has significant efficacy, the benefit of CPB for chronic pancreatitis pain is~     controversial and has not been studied in a rigorous manner.~      Objective: To assess whether EUS guided celiac plexus block decreases suffering,~     hospitalization, and opiate requirements related to chronic pancreatitis pain.~      Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic~     pancreatitis.~      Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual~     analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will~     be eligible.~      Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic~     ultrasound with celiac plexus block~      Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed~     by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior~     to the block. The ability to work and conduct normal activities, opiate medication~     requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to~     the block.~      Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo~     response in patients with pain related to chronic pancreatitis we anticipate that 83~     patients will need to participate to demonstrate a difference. We aim to enroll 90 patients~     in this study.~   "
50218|NCT02399787|"~     The aim of the post doc project is investigate which genes regulate implantation in order to~     analyze specific proteins and microRNA in the spent culture media with the long-term goal of~     developing a non-invasive method of embryo assessment and selection. This will be achieved~     by conducting a targeted NGS analysis, based on list obtained from a non-published pilot~     study. When further validated by q-PCR, the expression of specific microRNAs known to~     influence the final list of genes will be analyzed in the spent culture media and the~     protein products of the genes recovered from the media will be quantified. The level of~     specific microRNAs and proteins will be related to aneuploidy and implantation potential. If~     the level of specific microRNA and/or proteins correlates with pregnancy, the study will~     form the basis for developing a clinical applicable precise method of improved embryo~     selection and thus improved IVF treatment.~   "
50219|NCT02399774|"~     Leboride is a dental support device that was developed for reducing pain during active~     labor. It is made of an inert material, placed in the woman's mouth and does not disturb~     breathing, talking, or any other activity expected during labor. It is a single-use device,~     each user receives a new one.~      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that~     improve women's breastfeeding experience, and increase breastfeeding rates.~   "
50220|NCT02399761|"~     Parents of newborns will be invited to test if their newborns are affected with Aromatic~     L-amino Acid Decarboxylase (AADC) deficiency.~   "
50221|NCT02399748|"~     Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.~   "
50222|NCT02399735|"~     The purpose of this study is to explore the safety of NK cells from Sibship in patients with~     recurrent hepatocellular carcinoma after liver transplantation.~   "
50223|NCT02399722|"~     In surgical units negative pressure wound therapy (NPWT) is often used to facilitate wound~     healing. The recommended frequency of change every third to fourth day causes an immense~     workload.~      The purpose of this study is to evaluate the effect of an additional polymeric membrane~     interface dressing (PolyMem® WIC) as primary wound contact layer in NPWT in comparison to~     NPWT alone on the number of required dressing changes until wound closure as the primary~     endpoint. Secondary endpoints are: time to heal and wound associated pain.~   "
50224|NCT02399709|"~     Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately,~     there are few smoking cessation agents and their effectiveness has been shown to be~     relatively limited and is associated with potential unwanted effects. Therefore, the~     discovery of new medications that can facilitate abstinence and reduce relapse to cigarette~     use represents a pressing necessity. In the attempt to find molecules that could reduce~     drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not~     food, seeking behavior in rats. This discovery of a new therapeutic application for an~     already marketed class of compounds may greatly facilitate the translation from preclinical~     to clinical setting. In this project, we aim at investigating whether simvastatin is an~     effective smoking cessation agent in humans.~      The study design is a multicenter, randomized, double blind 2 parallel groups, clinical~     trial with an intention-to-treat analysis. Smokers will randomly be assigned to receive~     simvastatin or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100~     receiving placebo) will be recruited through already established networks of general~     practitioners. The primary outcome of the efficacy of simvastatin will be the rate of~     smoking abstinence during the last month of the 3-month treatment period, defined as~     reported continuous abstinence from smoking and confirmed by expired air carbon monoxide and~     urinary cotinine concentration. The last assessment will be done 6 months after the~     predefined quit date.~      The results of this proof-of-concept study may open new perspectives in the treatment of~     tobacco use and dependance.~   "
50245|NCT02399436|"~     Most of the nation's serious chronic health challenges and causes of death, including~     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both~     poor diets and associated disease are disproportionately common in the Appalachian counties~     of eastern Kentucky, a region with stark health inequities, including elevated rates of~     obesity, overweight, and premature mortality. The purpose of this pilot study is to evaluate~     a multi-component intervention developed through community-based participatory research~     methods for improving access to healthy foods and enhancing dietary intake in eastern~     Kentucky. The intervention components evaluated in this study consist of a social marketing~     campaign delivered to middle and high schools to promote healthy snacking and water~     consumption, and a series of group cooking classes for adults.~   "
50309|NCT02398604|"~     This study is intended to evaluate the safety and feasibility of intramyocardial injection~     of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA)~     surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.~   "
69507|NCT02147561|"~     This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with~     chronic migraine.~   "
50225|NCT02399696|"~     Primary care patients typically do not receive adequate PTSD treatment because of their~     reluctance to engage in empirically-supported treatments offered in specialty care settings.~     Effective treatments for PTSD are also typically not provided in primary care. Brief~     skill-based treatments offered in primary care may alleviate symptoms and prepare patients~     to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited~     for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP)~     to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from~     the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP~     condition demonstrated significantly greater decreases in PTSD and depressive symptoms from~     pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12~     week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD,~     averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses~     revealed that the describing, non-judging, and acting with awareness facets of mindfulness~     may account for decreases in PTSD. Our data support preliminary efficacy of a brief~     mindfulness-based intervention for Veterans with PTSD in primary care. Further research is~     needed to investigate how PC-bMP may facilitate engagement into full length~     empirically-supported treatment for PTSD.~   "
50226|NCT02399683|"~     Mucosal immunology during helminth infection~   "
50227|NCT02399670|"~     The femoral-offset (FO) is one of the important perioperative parameters in THA. A~     prospective cohort study was conducted between September 2010 and December 2013. All~     patients with unilateral primary osteoarthritis (OA) treated with THA were considered for~     inclusion. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or~     fractures were excluded. Global FO was measured in each patient within 3 months before the~     THA and at the second postoperative day using a standardized protocol. According to the~     postoperative measurement, patients were divided into three groups: 1) the decreased FO~     group, where the FO of operated side was reduced more than 5mm compared with the~     contralateral side, 2) the restored FO group, where the FO of operated side was within 5mm~     restored compared with the contralateral side, and 3) the increased FO group, where the FO~     of operated side was increased more than 5mm compared with the contralateral side.~      Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and~     EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip~     and measurement of the abductor muscle strength.~   "
50228|NCT02399657|"~     A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant~     (Ozurdex®) on hard exudates of diabetic macular edema.~   "
50229|NCT02399644|"~     Only to a limited extent has been compared the effectiveness of physical exercise and~     psychological interventions in subjects with chronic pain. Knowledge about this is necessary~     in order to compose optimal multimodal rehabilitation programs at different health care~     levels. Moreover, assuming that both types of interventions have effects, these effects may~     necessarily not concern the same outcome variables. Therefore it may be important to~     understand to what extent the effects overlap and the extent to which the effects are~     isolated to an intervention.~      The overall strategic purpose of the present study is to develop effective multimodal~     rehabilitation programs. In this study the effectiveness of following three interventions~     are compared.~        -  Group-based rehabilitation according to a concept based on an Acceptance and Commitment~          Training -Stress Management Intervention (ACT-SMI)~        -  Group-based rehabilitation compromised of physical exercise (Exercise).~        -  Group-based discussion concerning pain and its consequences (i.e., the control group,~          CON) The effectiveness is investigated with respect to long-term effects on pain and~          its consequences, including perceived health and return to work / sick leave.~      The overall hypothesis is that the former intervention means better long-term results~     because it clearly helps the individual to process the psychological aspects of itself~     likely to have long lasting effects.~   "
50230|NCT02399631|"~     An enhanced recovery program has been developed to provide for colon cancer patients faster~     and more personalized postoperative treatment. Most of the previous studies have showed that~     the efficacy of the enhanced recovery program on both subjective and objective physical~     recovery of patients. However, such studies are rarely conducted in South Korea. The purpose~     of this study is to evaluate the feasibility and efficacy of a postoperative enhanced~     recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary~     hospital in Korea.~   "
50231|NCT02399618|"~     Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased~     incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal~     Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is~     prudent to consider less invasive and more convenient means of administering FMT. The~     majority of reported FMT procedures have been performed with fresh or frozen stool~     suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose~     capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed~     the need for invasive gastrointestinal procedures. However, to avoid undesirable~     disintegration, those capsules containing stool suspensions must be kept frozen all the~     time, which extremely limits their widespread application. The purpose of this study is to~     evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.~   "
50232|NCT02399605|"~     Assess whether the application of electrical stimulation in patients undergoing subcutaneous~     colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of~     postoperative ileus, improving the results of morbidity and mortality, hospitalization and~     health care costs.~   "
50233|NCT02399592|"~     The purpose of this study is to to investigate the effect of tocotrienol as a nutritional~     supplement in combination with bevacizumab in patients with advanced ovarian cancer.~   "
50234|NCT02399579|"~     The purpose of this study is to better standardize the symptom recording of cat allergic~     persons under real-life conditions. A new self-assessed, home-based symptom score will be~     tested.~   "
50235|NCT02399566|"~     The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance~     therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS).~     Based on prediction of different potential benefit groups, this study may help the~     oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.~   "
50236|NCT02399553|"~     The number of turf fields has experienced an important increase in public and private~     facilities during the last years. This artificial surface will be predominant in any soccer~     field in the next years. Among turf fields there are many different types depending on their~     construction characteristics (with and without asphalted base, elastic base, rubber filling,~     etc.). Officially all types of artificial turfs should have similar stability and impact~     absorption characteristics. On the other hand there is a great variety of soccer-boots,~     especially for youth soccer players, similar to the football stars.~      Many evidences support the fact that when a person exercises many different type of~     impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems.~     However, it is not known yet whether this effect can be extended or shortened depending on~     the type of artificial surface and soccer-boots used, or even more whether it could be more~     or less dangerous and/or provoke injuries/disagreement among the users. Little information~     is available in youth soccer player pointing in the same direction but still controversial.~     Furthermore, bone strength do not only depends on bone mass but on bone structure and~     microarchitecture. The cross sectional area, cortex thickness or trabecular density are~     important aspects of bone health. There are few studies on the effect of interaction between~     turf field and soccer boots on bone architecture of youth soccer players. This information~     is relevant for present and future health of adolescents practicing football and for all the~     organizations promoting this sport.~      Due to the fact that turf fields are preferentially used by youth populations, it is~     important to know the real effects of the interaction between of different type of~     artificial surfaces and soccer boots on children bone mass development. Nowadays, there are~     no data and/or defined guidelines that can answer those unresolved questions, thus the main~     aim of the present project is to identify which turf field and soccer boots are the most~     adequate to optimize the acquisitions of bone mass in children soccer players.~   "
50237|NCT02399540|"~     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have~     limited effects on motor recovery. Therefore, investigating new potential therapeutic~     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of~     non-invasive electrical stimulation where a weak current is applied through electrodes over~     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which~     can last up to one day with late LTP-like plasticity protocols- in a polarity and~     site-specific manner, and (2) facilitate motor learning and stroke recovery. However, it is~     unknown how the motor cortex excitability changes that follow tDCS relate to the increase in~     motor learning and recovery potential. The currently upheld hypothesis is that motor~     learning needs to be synchronized in time with electrical stimulation (paired stimulation),~     but recent results from our lab suggest that tDCS also increases skill learning after~     stimulation has ended (unpaired stimulation). If this is true, tDCS has a much larger~     therapeutic window and is a more valuable clinical tool than currently believed. Therefore,~     the investigators want to investigate how late LTP-like plasticity tDCS affects the increase~     in skill learning normally seen with tDCS when applied 24 hours before training. The outcome~     of this study can provide important guidelines on effective motor therapy during stroke~     rehabilitation.~      Objective: Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients~     on skill learning 24 hours later.~      Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic~     stroke patients. Main study parameters/endpoints: The main objective of the study is to~     determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a~     motor learning paradigm, the investigators will use a circuit tracking task which chronic~     stroke patients perform better if tDCS is applied concurrently. During this task, patients~     have to trace a cursor over a circuit as fast and accurately as possible by moving a~     computer mouse. Skill will be quantified by calculating a combined speed/ accuracy score and~     skill improvement compared to baseline (LI; the learning index) will be compared between the~     sham, conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like~     plasticity tDCS groups.~   "
50238|NCT02399527|"~     Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the~     understanding of the natural history, long-term outcomes, risk factors for morbidity and~     mortality, and the relative benefit of medical therapies and procedures is limited.The goal~     of this project is to better understand these diseases and improve the care of theses rare~     patients. To do this, the investigators are conducting an observational study of patients~     with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective~     data on mortality, morbidity, treatments, and functionality as well as quality of life.~   "
50239|NCT02399514|"~     Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of~     patients treated with RePneu coils. This monocenter prospective study investigates the~     effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced~     disease stages of pulmonary emphysema.~      Patient's sleep will be studied in three Polysomnography measurement nights, one prior to~     Coil Treatment, one six months after, and one twelve month after.~      Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil~     Treatment.~      Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function~     parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).~   "
50240|NCT02399501|"~     Prospective comparative study including 100 infertile patients with suspected uterine~     lesion. 2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to~     evaluate uterine cavity.~   "
50241|NCT02399488|"~     Continuous haemoglobin determination could improve the outcomes of several patients in risk~     of bleeding during surgery. An in vivo calibration has been introduced to the device after~     our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous~     haemoglobin monitor has been made in various papers, although it has been compared to point~     of care devices, thus introducing an error as such point of care devices although validated~     for haemoglobin determination, are not as accurate as the gold standard. The validation of~     the gold standard calibrated device has not been described yet.~      When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy~     and precision of the continuous haemoglobin monitor could be good enough to be used~     interchangeably with the gold standard.~   "
50242|NCT02399475|"~     Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid~     hormone levels, is a common diagnosis in the elderly. The purpose of this study is to~     examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older~     with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition,~     participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits:~     baseline and while taking two different thyroid hormone preparations, levothyroxine and~     liothyronine. The investigators will also assess physiologic responses to these two~     different thyroid hormone medications to help us understand how the thyroid works in~     advanced age.~   "
50243|NCT02399462|"~     This is an open label safety and feasibility trial using Acthar® in addition to~     center-specific standard therapy including plasma exchange, for treatment of post transplant~     recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects~     will receive Acthar® 40 units subcutaneously twice weekly for two weeks then 80 units~     subcutaneously twice weekly for 24 weeks.~   "
50244|NCT02399449|"~     An approved treatment for anemia or low blood count due to chronic kidney disease is IV~     (intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in~     the blood. Many IV iron therapies are now available in both brand name and generic forms.~     One common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.~     Recently, a generic version of Ferrlecit was approved but was felt to be possibly more toxic~     than the brand product. The purpose of this research project is to see if the brand and~     generic IV iron products produce the same amount of iron in the blood in healthy volunteers,~     including an iron form that more toxic than other iron forms.~   "
50246|NCT02399423|"~     South Asians have a much higher risk of diabetes compared to Europeans and investigators~     don't know why this is. Investigators think that South Asians' capacity to store fat safely~     under the skin is lower than Europeans, so they start to store fat around internal organs~     and in liver and muscle, and at lower body weights than Europeans. These increased levels of~     internal fat storage are thought to increase risk of diabetes.~      The purpose of the study therefore is to investigate whether there are differences with~     weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in~     South Asians compared with Europeans. Investigators will compare South Asian and European~     men at the start of the study, after they have gained about 7% body weight, and again after~     they have lost 7-15% body weight (from peak weight) to see how gaining and losing weight~     affects fat storage within the body and the function of fat cells. Investigators will also~     assess the effect of weight gain and weight loss on metabolism, fitness and risk factors for~     diabetes and heart disease.~   "
50247|NCT02399410|"~     The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment~     consisting of perioperative combination chemotherapy with the vascular endothelial growth~     factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.~   "
50248|NCT02399397|"~     This study aims to evaluate the influence of age and sepsis on in vivo activity of OATP1A2~     using rocuronium (ROC) as a probe and evaluating the pharmacokinetics and pharmacodynamics~     in ASA I-III surgical patients. Thus, adult patients without sepsis (control group, n= 12),~     adult patients with sepsis (sepsis group, n= 12) and elderly patients without sepsis~     (elderly group, n= 12), all submitted to small to medium-sized surgeries who were induced~     with individual doses of rocuronium, fentanyl and propofol are being investigated.~   "
50249|NCT02399384|"~     The investigators propose to correlate 1) cardiac MRI pericardial adipose volume, 2) the~     presence of pericardial monocytes and 3) circulating immune biomarkers in persons with and~     without CHD and HIV infection compared to seronegative controls with known CHD. The~     investigators aim to test the hypothesis that higher amounts of pericardial fat deposition~     and increased presence of monocytes within this adipose tissue are associated with~     underlying coronary artery disease in persons with HIV infection as measured by cardiac MRI.~   "
50250|NCT02399371|"~     This phase II trial studies how well pembrolizumab works in treating patients with malignant~     mesothelioma, a cancer of the linings around the lungs (pleura) or abdomen (peritoneum).~     Monoclonal antibodies, such as pembrolizumab, work by blocking a protein called programmed~     cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.~   "
50251|NCT02399358|"~     Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize~     screening of hyponatremia development in the follow up period.~   "
50252|NCT02399345|"~     This open-label study will evaluate the safety and efficacy of co-formulated~     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or~     without ribavirin administered for either 4 or 6 weeks in treatment naive adults with~     chronic HCV-genotype 1 infection without cirrhosis~   "
50253|NCT02399332|"~     This project is an initiative to bring physicians, nurses, community pharmacists and~     patients together in collaborative planning in the management of diabetes, which aligns with~     the collaborative, team based aspects of family medicine as a community based discipline.~     Alberta funds both physicians and community pharmacists to complete a comprehensive~     assessment and plan for patients with qualifying medical conditions. Our research hypothesis~     is that a collaborative approach between healthcare providers involved in delivering care~     will improve individual patient outcomes with the primary outcome being improved glycemic~     control. Health care utilization and medication adherence will also be assessed. This~     project will compare the results of comprehensive annual health care plans implemented over~     a period of twelve months with or without involvement from community pharmacists. It is~     hypothesized that involvement of community pharmacists and their collaboration with~     physicians will lead to improved outcomes.~   "
50254|NCT02399319|"~     The purpose of this study is to compare subcutaneous internal fixation and open plating of~     the symphysis in patients with a disruption of the symphysis requiring stabilization.~   "
50255|NCT02399306|"~     This is a randomized, prospective, multicenter study. The aim of this study was to compare~     the changes of body weight,survival,toxicity,quality of life and opportunistic infection~     frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after~     chemoradiotherapy with or without enteral nutrition therapy.~   "
50256|NCT02399293|"~     Investigates computer based cognitive rehabilitation and training using the N-back task with~     a Visual Search task as an active control. The overall purpose is to provide (further)~     evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of~     convergence and divergence between patients with acquired brain injury and non-impaired~     subjects.~   "
50257|NCT02399280|"~     The purpose of the present study is to evaluate the effect of consuming higher caloric~     intake at lunch in contrast to dinner on weight loss of obese and overweight female adults~     when they are in a multidisciplinary weight loss plan .~   "
50258|NCT02399267|"~     The requirement for invasive mechanical ventilation is a defining feature of critical~     illness. Liberation or weaning is the process during which the work of breathing is~     transferred from the ventilator back to the patient. Approximately 40% of the time spent on~     mechanical ventilation is dedicated to weaning. Limiting the duration of invasive~     ventilation has been identified as a key research priority in critical care. Studies support~     the use of screening protocols (once daily vs. usual care) to identify weaning candidates~     and the conduct of tests of patient's ability to breathe spontaneously (SBTs). While once~     daily screening is the current standard of care in national intensive care units (ICUs), it~     is poorly aligned with the 24/7 ICU care environment wherein a critically ill patients'~     status can change from hour to hour. Only one large trial has compared alternative SBT~     techniques [T-piece vs PS (Pressure Support)]. No trial has compared a strategy of more~     frequent screening to once daily screening or alternative SBT techniques. The presence of~     respiratory therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to~     screen more frequently, conduct more frequent SBTs, and determine the optimal strategy to~     liberate critically ill adults from invasive ventilation.~      The investigators propose to conduct a pilot randomized trial in 100 critically ill adults~     comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs~     in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability~     to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of~     several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability~     to implement the trial as designed, (iii) assess current practices in sedation, analgesia~     and delirium management and timing of patient mobilization prior to conducting screening~     assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v)~     characterize trial participants based on weaning difficulty, and (vi) obtain preliminary~     estimates of the impact of the alternative screening and SBT strategies on clinically~     important outcomes.~   "
77582|NCT02041871|"~     To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity~     after liver resection for cancer.~   "
50259|NCT02399254|"~     Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical~     activity in the home and community settings is less clear. It may take a longer time for~     this increase in physical activity to occur. It has been stated in an editorial that it~     takes 3 months to train the muscles but 6 months to train the brain. The Investigators will~     first evaluate the change in physical activity following pulmonary rehabilitation using~     state-of-the-science motion detectors, then Investigators will follow the trajectory of~     physical activity over the next several months.~   "
50260|NCT02399241|"~     Lung Health research study (Development of a predictive model) - To determine whether the~     I-neb breathing parameters (flow data) can act as a surrogate marker for lung function~     (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung~     function in cystic fibrosis patients.~   "
50261|NCT02399228|"~     The initial proposed clinical study will be conducted in adult head and neck cancer~     subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy,~     safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of~     care. Santalis believes that the proposed study is a prudent and appropriate approach to~     investigate the potential of their product to prevent or improve oral mucositis symptoms~     commonly seen in subjects undergoing radiotherapy with or without chemotherapy.~   "
50262|NCT02399215|"~     This phase II trial studies how well nintedanib works in treating patients with~     neuroendocrine tumors that have spread from where they started to nearby tissue or lymph~     nodes (locally advanced) or have spread from the primary site (place where they started) to~     other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by~     slowing or stopping a certain type of receptor called vascular endothelial growth factor~     receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine~     tumors by blocking the growth of new blood vessels necessary for tumor growth.~   "
50263|NCT02399202|"~     To characterize the pharmacokinetics of LCI699 following a single oral dose in adult~     subjects with various degrees of impaired renal function.~   "
50264|NCT02399189|"~     The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R~     followed by autologous stem cells transplantation in newly-diagnosed primary central nervous~     system lymphoma.~   "
50265|NCT02399176|"~     The study measures change in bone mineral density by the DEXA scan before and two or more~     years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips~     and femur.~   "
50266|NCT02399163|"~     The study will evaluate and compare the potential anti-caries efficacy of a test regimen:~     placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily~     use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to~     remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness~     Recovery (%SMHR).~      This will be a single center, randomized, laboratory analyst blinded, placebo, four~     treatment, cross-over study in healthy participants. Participants will be assessed at~     baseline and at the beginning and end of each treatment visit to monitor clinical efficacy~     and safety.~   "
50267|NCT02399150|"~     Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as~     pain is a subjective measure, and serious causes needing surgical intervention do not always~     meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid~     in identifying surgical emergencies, but there are many influencing factors that have to be~     taken into account.~      Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility~     in measuring pain, and to evaluate potential influencing or confounding factors.~      Design: Prospective observational study in 200 patients presenting to the emergency~     department with acute abdominal pain.~      Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the~     Hôpital Universitaire Pitié-Salpétrière, Paris, France.~      Study population: 200 patients presenting to the ED with acute abdomen~      Eligibility criteria:~        -  Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18~          years~        -  Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance~      Procedure:~      Patients presenting to the ED with acute abdominal pain will be included after informed~     consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and~     baseline data assessed. All diagnostic procedures results and diagnosis made by the treating~     physicians as well as initiated treatment will be recorded Final diagnosis and outcome will~     be assessed by 2-week-telephone interview.~      Measurement of candidate biomarkers will be performed in collected material. Copeptin and~     SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained.~     Other biomarkers will be in consideration, depending upon availability and financial~     aspects.~      Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical~     Practice will be adhered to throughout this trial.~      Sample size considerations: The number of patients of this pilote study is based on the~     estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.~      Significance of the study: If a biomarker is found that safely discriminates between~     surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often~     young patients and will aid in optimized allocation of health care resources.~   "
50268|NCT02399137|"~     The purpose of this study is to determine whether the combination of MM-141 plus~     nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone~     based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients~     with high serum levels of free IGF-1.~   "
50269|NCT02399124|"~     This experiment is designed for post marketing data collection of a cryosurgical system~     [ICESENSE™3 of IceCure Medical], for the treatment of renal cell carcinoma (RCC).~   "
50270|NCT02399111|"~     The purpose of this research study is to investigate if a new negative pressure incision~     (surgical cut) management system, could reduce the occurrence of groin wound infections~     after vascular surgery. This is a single use, sterile dressing that is applied to the~     patient's skin. It has an attached battery-powered unit that provides negative pressure (a~     vacuum environment) to the dressing and a disposable canister for the collection of wound~     fluids. The patient is being asked to participate in this study because the patient is~     planning to have a vascular surgery procedure that involves groin incision.~   "
50271|NCT02399098|"~     Focusing attention is pertinent to the performance of closed self-paced motor tasks. The~     following study will examine the effectiveness of internal and external focus of attention~     instructions on the performance of a dart throwing task under rested and fatigue (after~     performing intense exercise) conditions. As well as the relationship between attentional~     focus instructions and gaze behavior under these two conditions.~   "
50272|NCT02399085|"~     This is an open-label, multicentre study to characterize the safety and efficacy of the~     human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with~     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no~     more than three prior systemic regimens and who are not eligible for high dose chemotherapy~     (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.~   "
50276|NCT02399033|"~     Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of~     recurrence in patients with hepatocellular carcinoma after hepatectomy.~      Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label,~     Parallel-Group Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group~     or the control group by the proportion of 2: 1.~      The total sample size: 1000 cases. Study Process: The study is divided into three phases:~     the screening phase, treatment phase, follow-up phase.To complete screening in two weeks,~     patients who fit the criteria were randomly assigned to Xihuang Capsules group or the~     control group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang~     Capsules (2g,bid), Continuously taking to cancer recurrence or death.Control group was not~     received Xihuang Capsules. In the first month to three years after treatment, Conducting~     visits for once every three months,to evaluate the efficacy and safety with hepatocellular~     carcinoma recurrence rate in the three years after hepatectomy as the primary outcome. When~     entering the follow-up phase, Keeping in touch with patients withdrew from the study for a~     clinic or telephone follow-up every three months.~      From signing informed consent till the end of the study, inspecting the adverse events and~     concomitant medications for all subjects in each visit.~   "
50277|NCT02399020|"~     33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of~     Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the~     intervention. Main outcome was improvement in social cognition according to specific~     measures of facial emotion identification, Theory of Mind, attributional bias, social~     cognitive accuracy and metacognitive overconfidence.~   "
50278|NCT02399007|"~     A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.~   "
50279|NCT02398994|"~     This multi-center randomized controlled trial evaluates if the addition of intravenous~     immunoglobulin to standard treatment of corticosteroids improves outcome in children and~     adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of~     participants will receive corticosteroids alone, whilst the other half will receive~     corticosteroids plus intravenous immunoglobulin.~   "
50280|NCT02398981|"~     In the developed world critical illness is routinely treated in an intensive care unit (ICU)~     by highly specialized physicians, nurses and support staff. This model of intensive care is~     spreading rapidly to low and middle income countries and as it spreads, challenges and~     limitations to this model arise. In resource-poor settings, inadequate human resources,~     training, and equipment all present barriers to safe and effective use of life-saving~     procedures. The advances in medical informatics and human factors engineering have provided~     tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools~     that can be applied in a complex and busy hospital setting. Real-time data feeds and~     standardized patient care tasks in a simulated acute care environment have been proven to~     have a significant advantage of a novel interface (compared to a conventional) in reducing~     provider cognitive load and errors. Currently researchers within the investigator's research~     group have developed and are pilot testing a simple electronic decision support tool:~     CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been~     successfully tested and validated in simulated settings and is being implemented as pilot~     study in 18 countries. Worldwide infant and early childhood mortality continues to be very~     high partly due to the inability to recognize and respond aggressively to critical~     illnesses. Investigators expect that adaptation of the algorithms from CERTAIN has potential~     to be a powerful tool to improve on the medical care of children in developing countries.~     Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN~     (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and~     evaluate the impact of the tool on the processes and patient outcomes.~   "
50281|NCT02398968|"~     Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An~     adequate iron status might reduce their prevalence. The aim of the study is to assess the~     percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron~     deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and~     severity of upper respiratory tract infections .~   "
50282|NCT02398955|"~     Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd.,~     Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer~     licensed for the treatment of de novo coronary lesions. However no data regarding the~     efficacy and safety of this stent in an all-comers patient population treated with~     percutaneus coronary interventions (PCI) have been published so far. In this registry the~     investigators aimed to collect clinical and angiographic information about an extensive~     all-comers employ of this novel stent.~   "
50283|NCT02398942|"~     Aim:~      The aim of this study is to analyze the clinical and radiological outcomes of patients with~     a proximal pole fracture of the scaphoid~      Primary null hypothesis:~      There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.~      Secondary null hypothesis:~      Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities~     of the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the~     Norway and 10.9 in the United States), 2 to 6 months after injury.~   "
50284|NCT02398929|"~     This is an open-label, placebo run-in study to investigate the genetic and biomedical~     predictors of blood pressure response to bisoprolol. After informed consent is obtained,~     subjects will be withdrawn from previous antihypertensive therapy and given placebo for at~     least 2 weeks. Compliance will be assessed using pill counting, and any subject will a~     compliance less than 80% during the placebo run-in period will be excluded from the study.~     Bisoprolol 2.5 mg will be given once daily for 6 weeks. At baseline and after 6 weeks on~     bisoprolol 2.5 mg the clinic sitting blood pressure, 24-hour ambulatory blood pressure (if~     the patient is willing to do this), clinical characteristics and biochemical profile will be~     measured. Central aortic blood pressure will be measured with the A-PULSE device at baseline~     and after 6 weeks treatment.~      After completing 6 weeks treatment with bisoprolol 2.5 mg daily, the patient will continue~     treatment with bisoprolol for a total of 24 weeks unless there is any adverse event that~     requires discontinuation of bisoprolol.~   "
50310|NCT02398591|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics~     of three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ~     53718678 when administered as single dose in fasting conditions in healthy Japanese adult~     participants in 3 cohorts.~   "
50287|NCT02398890|"~     Purpose: The overall prognosis of oncology patients admitted to intensive care has improved~     greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality~     in intensive care, more and more patients returning oncological circuit for the continuation~     of treatment of the underlying disease The existence of sequelae after the ICU (Intensive~     Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the~     continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery~     or evolution without tumor progression. However, no studies have evaluated the effects of~     resuscitation on subsequent cancer treatment strategies. It would thus become better~     appreciate the long-term oncology patients discharged alive from the hospital after a stay~     in intensive care.~      Main purpose of research :~      Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors,~     after an intensive care stay for other reason than elective surgery monitoring or securing~     an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated~     by the treating oncologist and classified total, partial or absent from that defined before~     or during the ICU stay~      Secondary objective of the research :~      Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.~      Evaluate survival, lifestyle and physical and psychological effects of these patients after~     discharge from the hospital over a period of one year. It is understood that all these~     secondary endpoints will interfere with the existence of an evolutionary neoplasia not only~     with the ICU stay. They will therefore be interpreted with caution.~      Study Type: observational Study Design: Prognostic study of routine care, national,~     prospective, cohort type ~   "
50288|NCT02398877|"~     This study evaluates the association between early trauma, depression and metabolic~     symptoms.~   "
50289|NCT02398864|"~     To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and~     safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy~   "
50290|NCT02398851|"~     The overall aim of this study is to create a trans-disciplinary chronic disease continuity~     of care model with health information technology, utilizing mobile devices such as tablets,~     iPads and smartphones.~   "
50291|NCT02398838|"~     This study examined the acceptability and feasibility of using a simplified regimen of~     medical abortion in the eastern and western regions of the country of Georgia. It was~     hypothesized that home use of mifepristone and buccal administration of misoprostol would be~     both acceptable and efficacious.~   "
50292|NCT02398825|"~     This study aims at evaluating the efficacy of treatment with ponatinib in patients with~     chronic myeloid leukemia who are in a chronic phase and who previously received treatment~     with imatinib but resulted to be resistant to it.~   "
50293|NCT02398812|"~     The objective of this pragmatic multi-center randomized controlled trial is to test the~     effectiveness of interprofessional medication assessment in older patients needing home care~     due to their diseases or decreased functional capacity in primary care. The main hypothesis~     is that intervention has a positive impact on functional capacity and for rational and safe~     use of medicines.~   "
50294|NCT02398799|"~     The aim of this randomized controlled trial was to evaluate the effects of an integrated~     dyad care program with education and psychosocial support to patients with chronic heart~     failure and their partners during a post-discharge period after acute deterioration of heart~     failure.~      Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or~     a psycho-education intervention delivered in three modules through nurse-led face-to-face~     counseling, computer-based education and other written teaching materials to assist dyads~     develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24~     months to assess perceived control, perceived health, depressive symptoms, self-care,~     knowledge, caregiver burden and health care utilization.~   "
50295|NCT02398786|"~     The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that~     collects information on myotonic dystrophy (DM) to aid researchers in developing new,~     effective treatments and help identify participants for research studies and clinical~     trials.~   "
50296|NCT02398773|"~     This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography~     (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with~     newly diagnosed breast cancer that has spread to other parts of the body. FES is a~     radioactive form of the hormone estrogen and may light up where cancer is in the body.~     Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help~     doctors predict how well the cancer will respond to treatment.~   "
50297|NCT02398760|"~     Nowadays, the research priority in low back pain area have been find subgroup of patients~     with the same characteristics that might achieve better outcomes in a specific intervention.~     However, even though the studies in this area have increased, questions of this nature~     remaining without an adequate answer, or with limited evidence. Therefore, the investigators~     propose to examine the ability of clinical tests, developed to assess alterations related to~     clinical lumbar instability, to identify subgroups of patients with non specific chronic low~     back pain that may have better outcomes after a motor control exercises intervention.~   "
50298|NCT02398747|"~     The primary objective of this study is to investigate the safety and tolerability of~     continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced~     solid malignancies.~   "
50299|NCT02398734|"~     SONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a~     demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler~     monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain~     infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic~     energy on the reduction of risk of brain infarctions by the activation of endogenous~     fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic~     or asymptomatic internal carotid artery stenosis.~      The sample size is based on an expected 2.5% reduction of stroke or TIA during the 30-day~     postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the~     control group (estimated prevalence, 4 %). Pre-study calculations showed that a minimum of~     704 patients in each group is needed to reach a significant difference with an alpha value~     of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10 % would be lost to follow-up~     or refuse to participate in the study.~      Consecutive patients will be assigned to the sonolysis or control group by a~     computer-generated 1:1 randomization. In patients randomized into sonolysis group, middle~     cerebral artery segment in a depth of 55 mm will be continuously monitored during~     intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic~     energy.~      In patients randomized into control group, the transcranial Doppler probe will be fixed in a~     required position using a special helmet as in sonolysis group patients, but middle cerebral~     artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz~     transcranial Doppler probe with a maximal diagnostic energy and the TCD monitoring will be~     stopped afterwards.~      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate~     endogenous fibrinolytic system during CEA with consecutive reduction of stroke or TIA, and~     the number and volume of brain infarcts, can lead to the increase of the safety of CEA in~     patients with internal carotid artery stenosis. The investigators can presume that up to 50%~     of patients indicated for CEA can be treated using these methods in the future.~   "
50300|NCT02398721|"~     Ideally randomized controlled trials should be carried out to compare the cost-effectiveness~     between FNAC and watchful waiting but such studies are very difficult to conduct in practice~     because they require following up very large number of subjects for a long period of time.~      The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference~     (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to~     determine the cost-effectiveness of two strategies in managing small incidental thyroid~     nodules for the Chinese population in Hong Kong.~   "
50301|NCT02398708|"~     The purpose of this study is to examine the gut bacteria, levels of peripheral blood~     inflammation markers, and symptoms in patients with and without chronic graft-versus-host~     disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The~     hypothesis is that individuals with cGVHD will have lower levels of microbial diversity,~     higher levels of inflammatory metabolites in stool and peripheral measures, and higher~     levels of symptoms than individuals without cGVHD.~   "
50302|NCT02398695|"~     The fact that dental caries remains a major public health problem mandates that oral-health~     researchers explore new strategies for assessment of caries risk, as well as for caries~     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis~     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of~     caries research has been on identifying and characterizing acid-generating bacteria and the~     mechanisms of acid resistance. The purpose of this study is to investigate over time the~     relationship between alkali production and caries.~   "
50303|NCT02398682|"~     The study pilots an outreach service for Acute kidney injury (AKI) patients, based on~     electronic alerts. Using the alerts we will contact the primary clinician caring for the~     patient with AKI in the Intervention group. The study has a control group of patients~     receiving good standard care, but without Outreach. The aim is to reduce morbidity and~     mortality in the syndrome, and also to reduce healthcare costs.~   "
50304|NCT02398669|"~     Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg~     dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.~   "
50305|NCT02398656|"~     This trial will enroll patients that have been diagnosed with a transient ischemic attack~     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a~     minor stroke faces the possibility of long-term disability and even death, regardless of~     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve~     or worsen over the hours or days immediately following a stroke. TEMPO-2 is a minor stroke~     trial for patients presenting within 12 hours of their symptom onset. Patients will be~     randomized to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a~     single, intravenous bolus (0.25mg/Kg) immediately upon randomization. Maximum dose 50mg. The~     control group will receive antiplatelet agent(s) as decided by the treating physician.~     Antiplatelet agent(s) choice will be at the treating physician's discretion.~      TEMPO-2 Coordinating Centre is located in Calgary, AB, Canada. There will be approximately~     50 sites participating worldwide.~      Dr. Shelagh Coutts is the Principal Investigator.~   "
50306|NCT02398643|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data has shown that COPD is associated with substantial cardiovascular~     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in~     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk~     with stable COPD, and the exaggerated CV risk during exacerbations of the disease are~     unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up~     of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a~     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies~     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.~     Disease management programs, such as pulmonary rehabilitation and patient self-management~     education, are part of guideline therapy for COPD; however, these are not regularly~     implemented following a hospitalization, and how these interventions affect patient~     outcomes, behavior, physical activity, inflammation and CV risk have not been well studied.~     The proposed long-term project will examine how early referral to chronic disease management~     programs after hospital discharge, affect patient outcomes. This study will provide~     invaluable information about outpatient management for a disease which has a tremendous~     impact on healthcare.~   "
50307|NCT02398630|"~     Abstract:~      Recent advances in reproductive medicine have generated a demand for more accurate imaging~     methods for identifying the specific cause of female infertility and other gynecologic~     disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the~     established technique of hysterosalpingography are combined with the cutting-edge technology~     of multidetector computed tomography (CT) to allow a comprehensive and highly accurate~     evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike~     ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of~     depicting both the external and internal surfaces of the uterus, fallopian tubes, and other~     pelvic organs, providing high-resolution data that are suitable for two- and~     three-dimensional reconstructions and virtual endoscopic views. Thus, virtual~     hysterosalpingography may prove to be superior to other noninvasive modalities for~     evaluating tubal patency. Moreover, in comparison with conventional hysterosalpingography,~     which may involve cervical clamping, virtual hysterosalpingography is painless. Because of~     the health risks associated with ionizing radiation, the use of another modality (eg, MR~     imaging, US) may be preferred if the presence of a focal uterine lesion is strongly~     suspected. However, virtual hysterosalpingography with multidetector CT may provide a~     diagnostic advantage in complex cases.~   "
50308|NCT02398617|"~     Heart failure is a chronic and frequently terminal illness associated with poor quality of~     life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent~     guideline updates have highlighted the need for improved focus on end-of-life and palliative~     care of advanced heart failure patients, in whom symptom burden can be high and treatment~     options are often limited. The aims of this study are to evaluate the feasibility of~     implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive~     care intervention concerning multiple domains of end-of-life care not often included in~     regular, outpatient clinic visits.~   "
50313|NCT02398552|"~     Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the~     standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule~     was reported with a high rate of dose reduction and dose discontinuation because of the~     safety profile. So investigators conducte this randomized, multi-center phase II study to~     determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the~     same efficacy in terms of progression-free survival, objective response, and overall~     survival, while reducing drug-related toxicity.~   "
50314|NCT02398539|"~     This protocol describes a randomized, two arm clinical trial comparing two topical~     treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects~     are randomized to either group 1or group 2 treatments:~      Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at~     the discretion of the investigator or if there is resolution of the of the hypergranulation~     tissue.~   "
50315|NCT02398526|"~     This observational prospective single arm cohort study is designed to assess pain and bone~     pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC)~     patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition,~     overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal~     event (SSE), course of blood counts, and safety will be assessed.~   "
50316|NCT02398513|"~     The primary objective of this study is to define the pharmacokinetic of Regorafenib~     administered orally as a single agent in Chinese patients with advance solid tumors.~      The second objective include the evaluation of safety, tolerability, and efficacy of Chinese~     patents treated with Regorafenib~   "
50317|NCT02398500|"~     The purpose of this first-in-human study is to evaluate the safety and tolerability of~     single ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in~     neovascular age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded~     at a safe and tolerated dose in treatment naïve nvAMD subjects to compare a single~     intravitreal (IVT) dose of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for~     change from baseline in best-corrected visual acuity (BCVA) at Week 12 (Day 85).~   "
50318|NCT02398487|"~     This is a pilot study to compare efficiency and tolerability of a personal vaporizers (PV)~     new generation electronic cigarette loaded with nicotine e-liquid with cigalike new~     generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of~     well characterized regular smokers unwilling to quit.~   "
50319|NCT02398474|"~     Iliac crest bone graft harvest is associated with acute pain that can lead to chronic~     postoperative pain. Local anesthetic infiltration and regional anesthesia could be of~     interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the~     associated risk of chronic postoperative pain. In this surgery, local anesthetic~     infiltration of the iliac crest is associated with a pain reduction compare with placebo.~      Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative~     analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane~     block) has been recently described. Considering the nerves trajectories, the TFP block is~     probably anatomically the most appropriate block for analgesia after iliac crest bone graft~     harvest.~      The aim of this study is therefore to assess the benefit of an ultrasound TFP block for~     analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration~     Design is prospective, randomized, double blind, controlled study~   "
50320|NCT02398461|"~     This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled,~     dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary~     outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS~     subjects.~   "
50321|NCT02398448|"~     The purpose of this study is to determine whether defined and limited changes in in vitro~     dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of~     allopurinol and the active metabolite oxypurinol.~   "
50322|NCT02398435|"~     The objective of this study is to assess safety, tolerability and early signs of efficacy of~     the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic~     auto-inflammatory disorder for which treatment remains empirical.~      This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin~     rashes with frequent components of sore throat, lymphadenopathies and neutrophilic~     leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features,~     the diagnosis includes some laboratory components that reflect the systemic inflammation:~     high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of~     interleukin 18 (IL-18).~      Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein~     (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and~     rheumatoid arthritis patients in phase I studies. It demonstrated good safety and~     tolerability profile with only mild adverse events in the injection site.~   "
50323|NCT02398422|"~     A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM)~     will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness~     of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and~     behavior regulation in the classroom. The LPP is designed as a neural exercise to reduce~     auditory hypersensitivities, to improve auditory processing of speech, and to improve~     behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural~     regulation of the middle ear structures to rehabilitate and to normalize the acoustic~     transfer function of the middle ear structures. The current study is being conducted to~     evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning~     challenged young people and will use objective measures to evaluate changes in acoustic~     transfer function of the middle ears structures, auditory processing skills, physiological~     state regulation, sensory symptoms, and academic pre and post testing.~   "
50324|NCT02398409|"~     The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention~     (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also~     determining it's cost effectiveness in the stroke and traumatic brain injury (TBI)~     populations.~   "
50382|NCT02397655|"~     The purpose of this multicenter study is to investigate the extra-/intra-cranial~     atherosclerosis distribution pattern in chinese populations with transient ischemic attack~     and ischemic stroke and analyze the influencing factors of atherosclerosis distribution~     pattern.~   "
50325|NCT02398396|"~     This study will be an open label, exploratory immunogenicity study conducted by the Oxford~     Vaccine Group, University of Oxford. This study will investigate the breadth of protective~     activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®)~     vaccine as well as investigating the nature of the B-cell and T-cell responses induced by~     vaccination.~      The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized~     with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule.~     Blood samples will be obtained at baseline and after each dose of vaccine.~   "
50326|NCT02398383|"~     This project is designed to begin to characterize the abnormalities of glucagon secretion in~     subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance.~     Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related~     diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal~     tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return~     12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.~   "
50327|NCT02398370|"~     Prospective, open-label, non-randomized, study to be conducted at a single center. Ten~     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells~     (PMD-MSCs) into the penis for the treatment of mild to moderate erectile dysfunction. Follow~     up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be~     evaluated for re-injection beginning at 3 months. Eligibility is determined by the clinician~     based on patient reported treatment satisfaction.~   "
50328|NCT02398357|"~     To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic~     patients with portal vein thrombosis and to explore whether it can decrease the short-term~     rebleeding rate.~   "
50329|NCT02398344|"~     Previous studies found important function of brain in exercises regulation on healthy and~     athlete patients and this studies showed not invasive stimulation on temporal cortex brain,~     induces electrics field to insula cortex, in addition modulate autonomic nervous system~     cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure~     immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left~     temporal cortex in the cardiorespiratory parameters (functional capacity, perception of~     efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke.~     Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult~     patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as:~     Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the~     Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on~     right and left temporal cortex region (T3 area) and cathodic position in contralateral~     supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during~     stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator~     turns on for 30 seconds. Results: The primary results will analyze cardiac frequency before~     and after tDCS and second step will assess the travelled distance on walking test for 6~     minutes with and without tDCS and compare these respiratory reviews results with stroke~     gravity.~   "
50330|NCT02398331|"~     The purpose of this study is to assess the impact on sexuality in women with a spinal cord~     injury, twelve months after their first return to home, of a program including structured~     information and education on sexuality, delivered 6 months after their first return to home.~   "
50331|NCT02398318|"~     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain~     stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for~     refractory OCD. However, large scale randomized controlled trials to evaluate the~     effectiveness of this approach are rare.~   "
50332|NCT02398305|"~     To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary~     intervention (PCI) the cardiologist can choose between the femoral artery and the radial~     artery. In the University Medical Center Groningen the femoral artery is commonly used.~     After intervention the puncture site is closed with an arteriotomy closure device (ACD).~     Patients after radial access receive a pressure bandage at the puncture site, usually the~     Terumo (TR) wrist bandage.~      The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac~     catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1~     hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding~     complications after the procedure. In patients with radial access, the TR bandage will be~     removed according to current protocol after 4 hours and additionally 1 hour observation is~     required. Several cardiologists have the intention to use the radial artery more frequent~     for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73%~     decrease in major bleeding complications compared to femoral access. Also there are no~     significant differences in MACE. Even so there are no differences in success percentage for~     cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J.~     2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the~     short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients~     after radial access post procedural admission time is approximately 5 hours. To guarantee~     patient throughput, uniformity of care and more efficient use of capacity of the short-stay~     unit, patients after radial access should not have a longer hospital admission time than~     patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5)~     have shown that it is safe to deflate the TR wrist band faster than four hours.~      Objective of the study:~      To describe the differences in safety, patient comfort and admission period after diagnostic~     cardiac catheterization through radial access, between the current protocol and the protocol~     of fast desufflation by Carrington et al.~   "
50333|NCT02398292|"~     The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a~     6-week nutrition, movement, and mindfulness program for youth with recent diagnosis of~     psychosis.~   "
50334|NCT02398279|"~     This study evaluates the addition of L-Arginine to the usual regimen in the treatment of~     schizophrenia in adults. As a requisite of crossover design, half of the participants~     started with L-Arginine and the other half with placebo and switched over after a three~     weeks use and one week of a washout period.~   "
50335|NCT02398266|"~     The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is~     an approach that can assess the total impact of the complex pathophysiologic processes in~     patients with limb ischemia, particularly in those with diabetes in whom distal arterial~     disease and abnormal microvascular functional responses are common. This trial is designed~     to: (a) optimize methods for assessment of limb perfusion at rest and during stress using~     contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able~     to provide non-linear signal without destruction at medium acoustic pressures, and (b) to~     test whether perfusion imaging provides incremental information on the severity of disease~     in patients with peripheral artery disease.~   "
50336|NCT02398253|"~     The purpose of this study is to assess the effects of CBT after a successful weight loss by~     a comprehensive weight loss plan on weight maintenance in obese female adults.~   "
50337|NCT02398240|"~     The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well~     tolerated and effective in children, adolescents and young adults with all stages of newly~     diagnosed Hodgkin lymphoma (HL).~   "
50339|NCT02398214|"~     Sleep problems during infancy are associated with behavior and emotional problems, poor~     language development , parental distress and mood disturbances, and overweight and obese~     children. The investigators proposed that children who receive the light, activity, and~     sleep training (LAST) intervention program in this study will have less parent report of~     problem sleep behaviors and longer duration of nighttime sleep compared to children with no~     intervention provided.~   "
50340|NCT02398201|"~     The purpose of this study is to gather preliminary data on whether bezafibrate can improve~     cellular energy production in mitochondrial disease.~      Mitochondrial diseases are rare inherited disorders that arise due to deficient energy~     production within the cells of the body. Consequently, the typical clinical features arise~     in organs with high energy requirements. Mitochondrial disorders exhibit highly variable~     clinical effects, both between individuals and within families. Characteristic symptoms~     include muscle weakness (myopathy), hearing loss, migraine, epilepsy and stroke like~     episodes in addition to diabetes and heart problems. Mitochondrial disorders can therefore~     impact considerably on both quality of life and life expectancy. Despite this, no proven~     disease modifying treatments are available.~      Pre-clinical studies have identified that several existing medications improve mitochondrial~     function. Of these, bezafibrate has the best supportive data and, because it is already~     licensed as a treatment for high blood fats, has a well characterised side effect profile.~      The investigators will therefore conduct a feasibility study of bezafibrate in people with~     mitochondrial myopathy. Ten affected participants will be recruited and will receive a~     titrating course of bezafibrate three times daily for 12 weeks.~   "
50341|NCT02398188|"~     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to~     subcutaneous fat in non-obese subjects.~   "
50342|NCT02398175|"~     The present study predicts that concomitant chest injuries in polytraumatized pediatric~     patients are a potential source of substantial morbidity and mortality.~   "
50343|NCT02398162|"~     This is an observational study of the natural immune response to scrub typhus in patients~     recruited from Chiangrai Prachanukroh Hospital, N-Thailand. Febrile patients with a positive~     IgM rapid diagnostic test will be asked if they wish to take part in a study to improve the~     understanding of how the body responds to scrub typhus. Blood samples will be collected from~     each participant (STP, n=60) at baseline (the day of presentation to hospital), 2 weeks~     later in hospital, 12 weeks after baseline at the clinic visit and 1 year later. Data on~     clinical presentation and relapses will be recorded. Control subjects are scrub typhus~     exposed patients from a rural village in the caption area of Prachanukroh Hospital (STE,~     n=80; approx. 40 children and 40 adults), and healthy adults blood donors from Bangkok~     (STH n=30) - these subjects will be enrolled for one single blood sample. The study team~     will also collect eschar swab specimens from STP group and a non-invasive specimen of the~     dark crust on the day of enrollment.~   "
50344|NCT02398149|"~     Upper extremity (UE) function is critical to maintaining independence. Better understanding~     of UE involvement in MS will provide necessary information to prioritize the design and~     selection of future interventions. The goal of the proposed project is to characterize UE~     involvement in a population of community-based persons with MS across the International~     Classification of Functioning, Disability & Health (ICF) domains and constructs.~   "
50345|NCT02398136|"~     The purpose of this study is to see whether ketamine, when given repeatedly via the nose~     (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher~     doses, ketamine has been used for many years as an anesthetic for medical procedures, and at~     lower doses may be an effective treatment in patients with major depression and PTSD.~   "
50346|NCT02398123|"~     The transversus abdominis plane (TAP) block is a relatively simple technique that provides~     myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in~     the prevention and treatment of parietal postoperative pain.~      Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided~     technique in different surgical procedures such as cesarean section, appendicectomy,~     laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients.~     Recently published clinical trials suggest that TAP block may represents an effective~     alternative to epidural anesthesia but further studies in larger population are necessary.~      Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low~     thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal~     laparotomy (2). Others found comparable results between continuous transversus abdominis~     plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction~     after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing~     effects, technical simplicity, and long duration of action. Some disadvantages include the~     need for bilateral block for midline incisions and absence of effectiveness for visceral~     pain (4). TAP block has been associated with good pain relief and decreased intraoperative~     and postoperative opioids requirements after laparoscopic surgery (5). The analgesic~     efficacy of the TAP block has been demonstrated in prospective randomized trials compared~     with placebo, in different surgical procedures such as abdominal surgery, hysterectomy,~     retro pubic prostatectomy, Caesarean section, laparoscopic cholecystectomy, and~     appendicectomy (6, 7, 8, 9, 5 and 10 respectively). All these studies have reported~     superiority of the TAP block in terms of reduction in visual analogue scale scores and~     morphine consumption. In this study the investigators try to compare Transversus Abdominis~     Plane (TAP) blocks versus caudal block for postoperative pain control after lower abdominal~     surgeries in pediatrics.~   "
50347|NCT02398110|"~     Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet~     comparative studies are lacking. The aim of this study was to compare the surgical outcomes~     of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.~   "
50348|NCT02398097|"~     Several studies have shown poor immune response to conventional influenza vaccines in~     HIV-infected individuals. This study was conducted expecting the more potent immunogenicity~     of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected~     adults.~   "
50349|NCT02398084|"~     The investigators want to understand how oral processing (chewing) of nuts affects particle~     size and the presence of lipid (fat) on the cut surfaces.~      The main objective of the study is to:~      Measure the size of nut particles that have been chewed sufficiently to be swallowed.~      The secondary objective of this study is to:~      Measure any changes in lipid content due to chewing and compare it to a prediction from a~     theoretical model.~      The investigators have developed a theoretical model for determining the release of~     nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used~     to calculate the amount of lipid released from chewed almonds. The model shows that only~     about 10% of the lipid is immediately released. The investigators require information on the~     particle size distribution (number of particles of each size) for other chewed nuts to~     calculate the amount of lipid released for other nuts. This will allow us to check the~     validity of our model for other foods.~   "
50350|NCT02398071|"~     Most daily activities involve alternating periods of exercise and rest. If recovery is slow~     following exercise it means that the next period of activity may be more difficult and the~     COPD patients becomes restricted in their daily life. Therefore, the investigators are~     interested to study the effectiveness and physiological effects of breathing with a PEP~     device during post-exercise period and hypothesize that~        1. Post-exercise breathing with PEP device will increase the rate of recovery more than~          breathing without PEP device.~        2. Post-exercise breathing with PEP device will not create harmful effects on~          cardiopulmonary function in COPD patients.~   "
50351|NCT02398058|"~     This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the~     safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin~     in patients with unresectable advanced/metastatic sarcomas. Patients will continue to be~     treated on this combination regimen in the absence of disease progression, intolerable~     toxicity or patient's decision.~   "
50352|NCT02398045|"~     The study aims to pilot a new computerised cognitive behavioural therapy programme for a~     small case series of adults with obsessive-compulsive disorder. The investigators~     hypothesise that the findings will demonstrate improvements in symptomatology following the~     programme. The programme will have longer-term aims of being rolled out over a number of~     IAPT services within the NHS, reducing waiting lists and increasing therapist time.~   "
50353|NCT02398032|"~     Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity~     in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with~     isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP)~     effect on these parameters.~      Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area.~     Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with~     SAHS without previous treatment. At least 30 patients are needed.~      Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during~     three months. Explorations will perform before and immediately after sleep at 0-, 3-, and~     6-months of trial.~      Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and~     aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal~     test, and ventilatory and inspiratory neural drive responses to progressive isocapnic~     hypoxia.~   "
50354|NCT02398019|"~     Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic~     inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to~     circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise~     (vasodilatation plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction~     is a major adverse complication after CPB surgery. Investigators hypothesize that the use of~     an increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical~     complexity. The safe use of OXIRIS® will reduce both cytokine circulatory levels and~     lipopolysaccharide (LPS) circulatory levels therefore decreasing SIRS and its systemic~     effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®)~     could potentially present less postcardiac surgery acute kidney injury (pAKI), lower~     intensive care unit (ICU) and hospital length of stay, and lower production of renal injury~     biomarkers (cell-cycle-arrest-proteins) tissue inhibitor of metalloproteinase-2 (TIMP-2) and~     insulin growth factor binding protein-7 (IGFBP-7).~   "
50355|NCT02398006|"~     Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures,~     with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle~     fractures occur in the middle third of the clavicle. There is a lack of evidence of~     randomised controlled trials assessing the best treatment of these fractures. The objective~     of this study is to evaluate the effects (benefits and harms) of conservative interventions:~     figure-of-eight bandage versus sling for the treating middle third clavicle fractures.~     Methods/Design: this project has been designed as a single-centre, parallel-group randomised~     controlled trial that will compare figure-of-eight bandage versus sling. The investigators~     aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle~     third clavicle fracture. Primary outcomes will be function or disability measured by DASH~     questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure,~     adverse events and numbers returning to previous activities. Data analysis: the chi-square~     test will be used to analyse the results of categorical variables, and Student t-test will~     be used to compare groups with respect to the numerical variables. The Student t-test is~     used to compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12~     months after the intervention. The significance level of 5% (alpha = 0.05) is used for all~     statistical tests such that tests have a value of less than 0.05 are considered~     statistically significant. Discussion: According to current evidence there is very limited~     evidence from two single trials only regarding the effectiveness of different methods of~     conservative interventions for treating clavicle fractures. This study is one of the first~     randomised controlled trials following the CONSORT statements designed to compare two~     conservative methods for treating clavicle fractures (figure-of-eight versus sling).~   "
50356|NCT02397993|"~     Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal~     pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in~     clinical routine.~      The aim of this study is to determine the levels of serum lipase, serum amylase and the~     tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of~     all three parameters was observed after surgery on the pancreas. For humans, these~     clinically important data are not yet available .~      It is assumed that the probability of pancreatitis with increased activity of lipase and~     amylase will rise with the number of puncture procedures as well as the size of the puncture~     needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could~     result in a false positive assumption of malignant neoplastic pancreatic lesion.~   "
50357|NCT02397980|"~     The purpose of this study is to investigate if behavioral intervention for dementia~     caregivers will decrease caregiver burden in caregivers of patients with dementia. This~     multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be~     randomized into two groups. One group consists of 40 participants who will receive~     behavioral intervention and 40 who will not receive intervention (waitlist control). The~     waitlist control group will be also provided the same intervention after the intervention~     group has completed the intervention. The behavioral intervention consists of 90-min-session~     a day with an interval of two weeks for 2 months. The primary outcome measures are the~     changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral~     Scale (PGCMS).~   "
50358|NCT02397967|"~     A national, multicenter, randomized, transverse clinical trial, estimating the existence of~     phonological deficits in children with NF1 children compared with control children without~     NF1 with the same reading level.~   "
50359|NCT02397954|"~     The objectives of this study are to evaluate the safety and tolerability of Zimura®~     intravitreous injection in combination with anti-VEGF therapy in subjects with Idiopathic~     Polypoidal Choroidal Vasculopathy (IPCV).~   "
50361|NCT02397928|"~     The study is a prospective, single arm, non-randomized, open label phase II trial, designed~     to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with~     Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The~     device is an experimental, portable, battery operated device for chronic administration of~     alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor,~     by means of surface, insulated electrode arrays.~   "
50362|NCT02397915|"~     The purpose of this study is to provide information on whether subjects with allergic~     rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or~     mometasone furoate (MF) nasal spray based on how the products feel to the subjects when~     administered.~      This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose,~     cross-over subject preference study to evaluate and compare patient preference for FF~     [(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects~     with allergic rhinitis. These two commonly used nasal sprays use different actuation systems~     (FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will~     evaluate whether this difference is reflected in the patient-assessed attributes of the two~     nasal sprays. The attributes or properties which are being assessed by the subjects for~     these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the~     nose, urge to sneeze, and irritation.~      The single-day study per subject comprises screening and all treatments and procedures.~     Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all~     subjects receive both products. One group of subjects will have two sprays of FF~     administered in each nostril whilst a second group will have two sprays of MF administered~     into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two~     groups will switch. The first group will then have two sprays of MF administered into each~     nostril and the second group will then have two sprays of FF administered into each nostril.~     After each treatment the subject will complete two sets of attributes questionnaires~     ('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be~     completed immediately following each treatment and a subject-rated 'delayed' attributes~     questionnaire will be completed approximately 2 minutes after each treatment. Upon~     completion of the second set of these two attributes questionnaires (immediate and delayed),~     a preference questionnaire will be completed by the subject. In the preference~     questionnaire, the subject states their preferred treatment, if any, for each of the product~     attributes, and finally states their overall preferred treatment, if any.~      There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after~     administration of the last treatment. The study is planned to enroll about 300 subjects.~   "
50363|NCT02397902|"~     The specific aim of the proposed study is to address the efficacy of conventional full-fat~     dairy products as part of the normal routine diet for improving vascular function and~     reducing blood pressure in middle-aged and older adults with elevated blood pressure. The~     investigators hypothesize that dietary intervention including whole milk and full-fat milk~     products will induce significant decreases in systolic blood pressure and arterial~     stiffness. The investigators also test the hypothesis that the reductions in blood pressure~     will be associated with the corresponding decreases in arterial stiffness and/or increases~     in endothelial vasodilatory function as well as improvements in arterial baroreflex~     sensitivity. If our hypotheses are supported by the results, the information could be used~     as a basis for recommendations for the use of whole milk and full-fat milk products in the~     secondary prevention of elevated blood pressure and vascular dysfunction.~   "
50364|NCT02397889|"~     The purpose of this study is to study new ways to treat post-traumatic stress disorder~     (PTSD). Current treatments for PTSD do not work for everyone and it can take time to~     determine whether a person responds to a chosen treatment. The purpose of this study is to~     see whether ketamine, when given repeatedly intravenously can produce a quick and persistent~     improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an~     anesthetic for medical procedures, and at lower doses may be an effective treatment in~     patients with major depression and PTSD. Ketamine given for PTSD is investigational, which~     means that the FDA has not yet approved the drug for treating this condition. In this study,~     the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute~     anesthetic effects compared to ketamine but has not been shown to treat or alleviate any~     symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine~     can treat or alleviate PTSD symptoms thereby acting as what we call an active control.~   "
50365|NCT02397876|"~     Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of~     infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based~     infant formulas are typically recommended. These formulas are expensive and not palatable.~     For older patients with CM allergy, the standard of care is avoidance of all CM products.~     The investigators cared for a CM allergic patient who was able to tolerate partially~     hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively~     hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly~     tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of~     CM. The investigators aim to identify characteristics of CM allergic subjects who can~     tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.~   "
50366|NCT02397863|"~     This open-label, multi-center study is open to patients 1 to 18 years of age at time of~     enrollment with medication resistant epilepsy.~   "
50367|NCT02397850|"~     There is a high risk for relapse in people suffering from depression. Studies indicate that~     the continuation of an acute psychotherapeutic treatment can reduce the likelihood of~     relapse. Therefore, this pilot study is aimed to investigate the feasibility of a~     continuation psychotherapy over 6 months, to support people suffering from chronic forms of~     depression in their daily life. The investigated continuation therapy itself includes about~     one telephone call per month (therapist - patient), focussing on the integration of~     strategies into the patient's daily routine. The patients receive either 30 minutes or 50~     minutes phone calls. On the one hand, these phone calls are supported by a workbook for~     patients containing psychoeducative elements, strategies and exercises. On the other hand,~     the therapist's work is based on a manual containing several modules and strategies. Both~     tools (workbook, manual) are understood as a framework, using the appropriate sections~     according to the patient's needs. As a result, the patients receive a continuation treatment~     which is appropriate and adapted to their individual situation.~      The main purpose of this pilot study is to evaluate the feasibility of a telephone based~     psychotherapeutic continuation treatment with a small sample of 20 patients suffering from~     chronic depression. In case of promising results the effectiveness of this kind of treatment~     is going to be investigated within a comparative trial (including face-to-face intervention,~     no intervention).~   "
50368|NCT02397837|"~     Converging evidence suggests that patients with bipolar disorder suffer from deficits in~     neurocognitive functioning that persist, despite remission of acute affective symptoms.~     These impairments contribute directly to functional disability, highlighting the need for~     interventions above and beyond standard treatments in order to achieve a full inter-episode~     recovery. The current study aims to investigate the safety and efficacy of a dopamine~     agonist (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar~     patients using a placebo-controlled, adjunctive, 12-week trial design.~   "
52832|NCT02365610|"~     To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects~     with inadequately controlled focal seizures.~   "
50369|NCT02397824|"~     OroDental anomalies are one of the phenotypical aspects of at least 900 rare diseases or~     syndromes affecting by definition less than 1 in 2000 individual within the population~     (almost 25 million persons in Europe).~      They are often described in association with other organs or system malformations, which is~     understandable, because the same genes and signalling pathways regulate the oral cavity~     formation or odontogenesis and the development of other organs. The various dental and~     orofacial anomalies can be classified by type (anomalies of tooth number, shape, size,~     structures of mineralized tissues, eruption, resorption, tumors; anomalies of oral mucosa;~     anomalies of tongue…), by signalling pathways and by syndrome families.~      These anomalies (for example hypodontia/oligodontia, amelogenesis imperfecta, dentinogenesis~     imperfecta…) become increasingly identified as diagnostic and predictive traits. Not only is~     it important to recognise, name appropriately and integrate these dysmorphic clues into the~     patient dysmorphology analysis but it is essential to synthesize the observations and~     confront them to existing data about similar orodental anomalies encountered in some of the~     corresponding mutant mouse models.~      Translational approaches in development and medicine, are relevant to gain understanding of~     molecular events underlying clinical manifestations and to enhance diagnostic accuracy.~      The aim of this study is to improve the knowledge, diagnosis and care of oral cavity~     pathologies encountered in rare diseases via the identification and gathering of national~     and international patient cohorts and to structure the molecular diagnosis behind these~     conditions via targeted next-generation sequencing assays. Data collection is implemented on~     validated accredited tools (databases) complying with the legal regulations about patient~     data protection and medical record collection. All information is anonymized.~      New effective diagnosis and therapeutic tools are being developed.~   "
50370|NCT02397811|"~     Human crossover pharmacokinetic study involving 12 subjects to determine the relative~     bioavailability of astaxanthin in six commercially available oral formulations.~   "
50371|NCT02397798|"~     The purpose of this study is to examine whether person-centered high-intense aerobic /~     strength training during five months reduces inflammation and disease activity, improve~     immune cell function, and increases muscle strength, fitness and ability of the individual~     independence in elderly patients with rheumatoid arthritis.~   "
50372|NCT02397785|"~     The goal of the study is to evaluate the use of a personal intravaginal, non- implanted~     electrical stimulation device in the treatment of chronic pelvic pain. The investigators~     propose a randomized controlled trial comparing the investigated device to a sham device.~     The primary outcome is pain control using the visual analog scale and brief pain inventory~     (18). Hypothesis: Subjects will report increased pain relief with the electrical stimulation~     device compared to those using the sham device alone.~   "
50373|NCT02397772|"~     The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but~     recent modelling has highlights that in all but low very transmission settings, the~     treatment of school-aged children is unlikely to interrupt transmission, and that new~     treatment strategies are required. This study seeks to answer the question: is it possible~     to interrupt the transmission of STH and if so, what is the most cost-effective treatment~     strategy and delivery system to achieve this goal? In this study, two paired community~     cluster randomised trials in different settings in Kenya will evaluate the impact and~     cost-effectiveness of annual school-based deworming, annual community-based deworming, and~     biannual community-based deworming. The interventions are (i) annual mass anthelmintic~     treatment delivered either to pre-school and school-aged children, as part of a national~     school-based deworming programme, or to the entire community delivered by community health~     workers. The primary outcome measure is the prevalence of hookworm infection (the most~     common STH species), assessed by periodic cross-sectional, age-stratified parasitological~     surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of~     Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of~     participants who will be followed longitudinally, worm burden and proportion of eggs~     unfertilised. A nested process evaluation, using semi-structured interviews, focus group~     discussions and a stakeholder analysis will investigate the community acceptability,~     feasibility given the local and regional health system structures and processes, and~     scale-up of the interventions.~   "
50374|NCT02397759|"~     The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is~     life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day~     after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of~     patients. It occurs in 40% of patients with severe SAH.~      Despite knowing this, the clinician has no biomarker for identifying patients at risk.~      The project presented is original and includes a screening method without a priori to~     identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In~     secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and~     blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.~      This study will take place over a year prospectively. The inclusion of patients will be in~     the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the~     establishment of an external ventricular derivation (EVD) will be divided into two groups~     and compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.~        -  Group 1: Patients with vasopasm~        -  Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a~          consensual definition. CSF samples (through EVD) and blood will be made upon arrival of~          the patient in intensive care and then between the 3rd and 4th day.~      As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a~     priori assumption by metabolomics. Analysis will be by chromatography system coupled to a~     high resolution mass spectrometer. This method does not justify effective calculation~     because it is a step of generating hypotheses requiring further biological validation based~     on the identified targets.~      The secondary criteria, we will study in the blood and CSF association between matrix~     metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.~      RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will~     define a metabolic profile that could identify predictive biomarkers vasopasm.~   "
50375|NCT02397746|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study~     to evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU)~     . These types of studies are required by regulatory authorities for all THA devices that do~     not have clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
50376|NCT02397733|"~     The main objective of this study i sto evaluate the impact of prophylactic cranial~     irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of~     life of small cell lung cancer patients.~      In addition, the trial assesses the potential changes in hippocampal volumetry due to~     cranial irradiation using magnetic resonance imaging.~   "
50377|NCT02397720|"~     There are 2 parts to this study: Part A (dose escalation) and Part B (dose expansion).~      The goal of Part A of this clinical research study is to find the highest tolerable dose of~     nivolumab and azacitidine that can be given to patients with AML. The goal of Part B of this~     study is to learn if the dose found in Part A can help to control AML.~      The safety of this drug combination will also be studied.~   "
50378|NCT02397707|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single~     dose of GS-9857 in adults with normal and impaired hepatic function. Adults in the healthy~     control group will be matched to adults with impaired hepatic function by gender, age (± 10~     years), and body mass index (± 15%).~   "
50383|NCT02397642|"~     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles~     triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus~     1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day~     of ovum pickup.~   "
50384|NCT02397629|"~     This is a cross sectional study to examine the relationship between serum calcium and PTHrP~     and serum PSA in men referred for prostate biopsy at Wake Forest University.~   "
50385|NCT02397616|"~     Retrospective analysis for HRM measurements using liquid swallows and a test meal for the~     presence of hiatal hernia. The investigators will correlate hernia descriptions with~     presence of acidic reflux and clinical complaints.~   "
50386|NCT02397603|"~     This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in~     patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral~     space.~   "
50387|NCT02397590|"~     A phase I clinical trial to compare the pharmacokinetics and safety of~     fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and~     Atorvastatin in healthy male volunteers.~   "
50388|NCT02397577|"~     Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air~     will be followed. Normal values will be calculated data of these tests.~   "
50389|NCT02397564|"~     The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional~     Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3~     months. Then follow up for the next 2 months.~   "
50390|NCT02397551|"~     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles~     triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with~     three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of~     ovum pickup.~   "
50391|NCT02397538|"~     An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction~     and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy~     Male Subjects.~   "
50392|NCT02397525|"~     Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients~     who have central abdominal bulging. Efficacy measurements will also be collected.~   "
50393|NCT02397512|"~     This study will test the influence of lactulose of the human gut microbiota. Healthy~     volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2~     days and 14 days after the test. Using sequencing and metabolomics techniques the~     investigators will identify changes in microbiota composition upon lactulose exposure.~   "
50394|NCT02397499|"~     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to~     subcutaneous fat in non-obese subjects.~   "
50395|NCT02397486|"~     The purpose of this study is to determine whether pentoxifylline and vitamin E are effective~     in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated~     with concurrent chemoradiotherapy.~   "
50396|NCT02397473|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as LY2951742 in participants with episodic cluster headaches.~   "
50397|NCT02397460|"~     This is a double-blind, randomized, 4 period, crossover study in up to 30 male and female~     healthy and chronic cough subjects.~   "
50398|NCT02397447|"~     The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in~     patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose,~     glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this~     improvement is due to an improvement in insulin sensitivity and insulin secretion. The~     purpose of this study is to evaluate the effect of the administration of Momordica Charantia~     on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.~   "
50399|NCT02397434|"~     A radical cystectomy + extended pelvic lymph node dissection is considered to be the~     treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this~     aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3~     tumors develop a pelvic recurrence. One- and 2-years survival for patients developing a~     local recurrence after cystectomy is only 8% and 3% respectively, with a median survival of~     <4 months. For patients with lymph node recurrence prognosis is somewhat better, but~     nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11%~     respectively. The investigators hypothesize that an earlier implementation of external beam~     radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node~     recurrence and improve disease free- and overall survival as local recurrence is linked to~     the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized~     trial and resulted in a 20% increase in 5-year disease free survival. Despite those~     impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant~     EBRT, till now. In the last decade, great technological advancements in EBRT planning, such~     as intensity modulated arc therapy (IMAT), and positioning have been realised. This has~     resulted in a better coverage of the target volume while sparing normal tissue (mainly small~     bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider~     the use of adjuvant EBRT in selected MIBC patients.~   "
50400|NCT02397421|"~     Patients with diabetes are at increased risk of developing heart failure (HF) which can lead~     to increased shortness of breath, reduced ability to exercise and in some cases premature~     death as the heart becomes less efficient at pumping blood around the body. However the~     treatment options for such patients remain limited.~      This study will test the safety and benefits of using a new class of drug, the SGLT2~     Inhibitor (Dapagliflozin), in treating HF and diabetes.~      Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the~     efficiency and the extent of thickening of the heart muscle before they start on treatment~     of dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise~     bike (if capable) and a walking test plus fill in some questionnaires on how their heart~     failure affects their quality of life. Participants will then continue as normal with~     currently prescribed medication for their diabetes and heart failure. After a year the tests~     will be repeated to determine if patients receiving Dapagliflozin benefited more than those~     who weren't on the drug.~      This study is funded by the European Foundation for the Study of Diabetes (EFSD)~   "
50401|NCT02397408|"~     This is a phase 2 study to assess the ability of 11C- and 18F-choline to detect and localize~     prostate cancer within the prostate gland in patients with unfavorable intermediate to~     high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C-~     and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in~     patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to~     assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of~     metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical~     prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C-~     and 18F-choline PET imaging in the detection and localization of local and metastatic~     disease with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI,~     advanced body NaF PET/CT), and to determine the temporal distribution of 11C- and~     18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be~     determined. An exploratory objective comparing regions of uptake from the 11C- and~     18F-choline PET/MR and sentinel lymph node imaging will be performed.~   "
50402|NCT02397395|"~     The purpose of this study is to evaluate the percentage of participants with sustained~     virologic response 12 weeks after the actual end of study treatment (SVR12)~   "
50403|NCT02397382|"~     The purpose of this study is to evaluate the potential effects of a single dose of 200~     milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe~     substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in~     participants with moderate to severe psoriasis.~   "
50404|NCT02397369|"~     Tobacco use is the single most preventable cause of premature adult death globally. It is~     one of the major causes of death and disease in India, accounting for nearly 0.9 million~     deaths every year.~      Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking~     in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor~     Vehicle Act has empowered the drivers and bus conductors to take suitable action against~     commuters found to be using tobacco. However in addition to commuters using tobacco in the~     BEST premises, large number of bus drivers and conductors are known to use tobacco on the~     job. There are various approaches to a tobacco cessation programme, like behavioural~     therapy, pharmacotherapy, providing self help material, telephone counseling, quit lines~     etc.~      Hence in terms of the workplace environment, understanding the factors leading to tobacco~     use maintenance and the effective approaches for cessation is of critical importance for~     formulating workplace tobacco prevention and cessation interventions that are applicable to~     transport work employee settings. The success of these methods needs to be comparatively~     evaluated among the different forms of tobacco users. Hence, the present study will be~     undertaken with the following objectives:~   "
50405|NCT02397356|"~     Ketamine has been administrated via the intravenous, intramuscular, subcutaneous, rectal,~     oral, transdermal, intranasal, sublingual, transmucosal, epidural, intrathecal, and~     intra-articular routes. Pharmacokinetic properties of inhaled ketamine have not been studied~     officially, but one of the investigators researchers has tested nebulized ketamine on~     himself with repeated painful stimulus and monitoring applied. Based on this experiment,~     analgesic effect is roughly estimated to begin in 3 minutes.Ketamine has been used~     successfully to treat acute pain in intranasal form. The primary purpose of this study is to~     evaluate whether nebulised S(+)-ketamine carries potential as a an analgesic bypassing first~     pass metabolism and without the need for intravenous access. Secondary aim is to assess the~     duration of analgesia obtained by nebulized S-ketamine. Thirdly, the aim is to evaluate~     whether inhaled nebulized ketamine decreases the need for rescue analgesia during PACU care.~     The subjects are recruited among patients coming in for a surgical intervention (orthopedic,~     gastrointestinal, plastic or urologic surgery) and needing further observation in~     postoperative care unit (PACU).~      It was calculated that sample size of 8 subjects per group would be required to achieve~     statistical power of 80% and detect a difference of 3 units in NRS-values with standard~     deviation of 2 units and type I error of 5%. To prepare for possible dropouts, total of 20~     subjects will be recruited (10 in each group).~      Patients will receive either nebulized placebo (i.e. saline) or ketamine (Ketanest-S) when~     they require pain alleviation in the PACU. Dosage of ketamine is 1 mg/kg. Patients will be~     randomized into two groups so that other group's first inhalation contains ketamine and~     second inhalation placebo and in the opposite order.~   "
50406|NCT02397343|"~     Hyperbaric oxygen may reduce neurophatic pain and promote wound healing. Established anti~     inflammatory effects of HBO may contribute to this effect. In a previous publication the~     investigators studied the effects of HBO on secondary hyperalgesia using a well established~     heat injury model. In a new - blinded study design, the investigators wish to investigate~     and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and~     improving therapy of severe pain conditions.~   "
50407|NCT02397330|"~     Interscalene brachial plexus block is the gold standard for perioperative pain management in~     shoulder surgery. However, this technique would have side effects and potential serious~     complications. The aim of this study is to compare between the combination of ultrasound~     guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene~     brachial plexus block for post operative analgesia after shoulder instability surgery with~     latarjet procedure.~   "
50408|NCT02397317|"~     The SPARK trial is testing the use of Kilovoltage Intrafraction Monitoring in prostate~     cancer patients being treated with Stereotactic Prostate Adaptive Radiotherapy. The~     researchers expect this trial to result in better targeted prostate cancer patient outcomes~     with lower toxicity. The potential application of Kilovoltage Intrafraction Monitoring to~     other tumour sites will pave the way for additional trials with Australasian radiation~     oncology leading the world.~   "
50415|NCT02397226|"~     200 patients with insufficient great saphenous veins will be randomized to either~     radiofrequency ablation or high ligation/stripping (open surgery). They will be examined~     according to standardized examination protocol Venous Clinical Severity Score (VCSS), with~     duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years).~     They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen~     Varicose Vein Questionnaire (AVVQ).~   "
50416|NCT02397213|"~     The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and~     degree of acute kidney injury after cardiac surgery.~   "
50409|NCT02397304|"~     Obesity is a major public health issue and its association with insulin resistance greatly~     increases risks for cardiovascular disease and type 2 diabetes. Exercise training is~     recommended for obese populations, but longitudinal studies indicate aerobic exercise~     training in obese individuals in the absence of weight loss has minimal impact on insulin~     resistance. High turnover of fat stored within muscle cells (i.e., intramyocellular~     triglyceride) during exercise and elevated muscle fitness (i.e., muscle oxidative capacity)~     are key features of the enhanced insulin sensitivity observed in endurance-trained~     individuals. It could be that longitudinal studies of exercise training in obese individuals~     failed to sufficiently stimulate intramyocellular triglyceride turnover during exercise and~     muscle oxidative adaptation as a result of failure to consider the impact of recent~     nutrition within their study designs. Performing exercise in the fed vs. fasted state can~     blunt these exercise responses in non-obese individuals. The researchers will investigate~     the hypothesis that an acute bout of aerobic exercise performed in the overnight-fasted~     versus fed-state can stimulate greater intramyocellular triglyceride utilization during~     exercise and enhanced expression of genes related to muscle oxidative adaptation in obese~     individuals. The expected outcomes will help to determine if exercising in the fasted state~     could be used to optimise metabolic adaptation to training in obese individuals. The future~     impact of this research could be the recommendation of a simple nutritional strategy~     considering meal timing to enhance the effects of aerobic exercise training in obese~     individuals, with potential long-term benefits for reducing insulin resistance and~     cardio-metabolic disease risk.~   "
50410|NCT02397291|"~     The purpose of this study is to determine whether the transplacental gradients for 6 polyols~     and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to~     normal pregnancies and b) to determine the relative contributions of transplacental~     transport vs production by the conceptus of both inositol (the major polyol) and mannose in~     IUGR and normal pregnancies using stable isotopic methodology.~   "
50411|NCT02397278|"~     This study plans to learn more about ways to treat a joint problem in the knee called~     Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting~     platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try~     to determine whether the injections lead to improvements in pain, performance of activities~     of daily living, improvements is sports activities and overall function and symptoms~     reduction. The investigators will compare PRP treatment to conservative therapy.~   "
50412|NCT02397265|"~     The diabetes technology group at Imperial College have developed a bio-inspired artificial~     pancreas (BiAP) system which uses a control algorithm based on a mathematical model of~     beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a~     portable handheld device, which interfaces the components of the artificial pancreas.~      Development of closed-loop insulin delivery devices to intensify control without~     hypoglycaemia has been extensively reviewed and have shown encouraging results . However,~     they have not yet proven to be robust when challenged with uncertainty and the external~     challenges (such as mixed meal contents, physical exercise, physiological stress and~     intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to~     outside the clinical environment.~      The principal research objective is to assess the safety and efficacy of a closed-loop~     system for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome~     from the studies will be % time spent with a glucose concentration in the target range~     (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or~     high glucose excursions and is the principal measure of efficacy for closed-loop insulin~     delivery systems in the scientific literature. Other measured outcomes will be % time spent~     in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in~     hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as~     measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic~     Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily~     Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean~     Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High~     Blood Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve.~     All measures have been previously published and validated.~      This clinical trial protocol assesses the artificial pancreas system in three separate~     sub-studies:~        1. In a bi-hormonal (insulin and glucagon) configuration~        2. During and after exercise with bi-hormonal closed loop, and standard insulin opened~          loop~        3. During and after meals of mixed composition with bi-hormonal closed loop, and standard~          insulin opened loop~   "
50413|NCT02397252|"~     The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV)~     testing in self-collected samples via the Eve Medical self-collection system© (Eve) with~     standard physician-collected samples for the detection of cervical intraepithelial neoplasia~     grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The~     performance of the Eve sample will also be compared with that of a second self-sample via a~     cobas® PCR Female swab.~      Approximately 1000 adult women with an abnormal Pap test at the level of an atypical~     squamous cells of undetermined significance or worse squamous or glandular abnormality~     (i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited~     over a period of 12 months via colposcopy clinics located at the Jewish General Hospital,~     St-Mary's Hospital, and the McGill University Health Centers (Royal Victoria Hospital).~      Participating women will undergo three cervical or cervicovaginal sampling techniques: 1)~     self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas®~     PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a~     questionnaire on their experience with the convenience and acceptability of the Eve system,~     relative to the other two sampling approaches. The decision as to which self-sample is to be~     collected first will be dependent on randomization~      HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the~     cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media~     with the two self-collected samples will be used to suspend the cellular material prior to~     HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the~     Department of Clinical Microbiology at the McGill University Health Centre for the HPV~     genotyping work.~      Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity,~     specificity, and predictive values (along with their respective 95% confidence intervals)~     will be calculated for each sample type to evaluate the clinical performance of the various~     sampling techniques. We will use CIN1+ as definition of disease but analyses will also be~     performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.~   "
50414|NCT02397239|"~     Protocol title:~      Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of~     pemetrexed versus pemetrexed until disease progression for metastatic non-squamous~     non-small-cell lung cancer (NSCLC)~      Study design:~      An open-labelled, randomized, phase 2 trial~      Indication:~      Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG)~     performance status of 0-1, and have received first-line or second-line chemotherapy with~     pemetrexed plus platinum for 4 cycles~      Treatment:~      Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease~     progression~      Objectives:~      Primary endpoint:~      1. Cost-effectiveness in the intention-to-treat population~      Secondary endpoints:~        1. Progression-free survival~        2. Overall survival~        3. Quality-of-life (QoL)~        4. Quality-adjusted progression-free survival (QA-PFS)~        5. Quality-adjusted life expectancy (QALE)~        6. Tumor response rate~        7. Adverse events~      Planned sample size:~      61 patients in each arm; total 122 patients~      Total number of sites:~      1 site~      Duration of patient enrollment:~      3 years~   "
50456|NCT02396680|"~     The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the~     initial dose.~   "
50417|NCT02397200|"~     Study design:~      Double blind, randomized, placebo controlled study. Participants will be randomly assigned~     either to the intervention group or the placebo control group. Randomization for the two~     study groups will be made in a ratio of 1:1.~      The primary objective of the study is to assess the effect of 6-12 months treatment with~     nutritional supplementation standardized formula, in short and lean female adolescents on~     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study~     are to assess the effect of 6-12 months treatment with nutritional supplementation~     standardized formula, in short and lean female adolescents on BMI SDS, growth velocity, time~     to puberty, quality of life and self-esteem The study will continue for 6 months of~     intervention versus active placebo, with additional optional 6 months (an extension period),~     in which participants at both groups, the intervention and the placebo, will be offered to~     continue their participation in the study with the study supplement.~   "
50418|NCT02397187|"~     The assessment of the efficacy of a structured, dimension-based, STI (Short Term~     Intervention) in de-compensated Personality-disorder, hospitalized, patients~   "
50419|NCT02397174|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged~     women that manifests itself with chronic anovulation, hyperandrogenism and insulin~     resistance. Available guidelines recommend lifestyle intervention although they do not~     suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study~     is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and~     Hypocaloric Diet in PCOS women.~   "
50420|NCT02397161|"~     Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular~     training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention~     training (AT) alone, and no intervention for improving reactive balance performance among~     children with developmental coordination disorder (DCD).~      Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with~     DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes:~     Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor~     control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings~     during MCT will measure the mental attention level, and surface electromyography recordings~     during MCT will indicate the lower limb muscle onset latency.~   "
50421|NCT02397148|"~     This study compares the morphological concordance between CT (computed tomography) and cone~     beam in sinus on 26 validated items. CT and cone beam is performed on each patient.~     Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of~     the ionizing radiations is lower with the cone beam.~   "
50422|NCT02397135|"~     IVF (in vitro fertilization) cycles fails more often than they succeed. Surprisingly very~     little effort is invested in defining the reasons for failure and possibly finding ways to~     improve the success on the next cycle. The investigators believe that the main reasons for~     failure are related to oocyte quality and indirectly to the follicle response for a~     particular patient. The investigators have developed a panel of biomarkers to assess the~     faulty follicular conditions leading to lower oocyte quality. Using these markers would~     indicate if a given cycle was characterized by over growth, over-luteinization, early or~     late trigger. Indeed our transcriptomics analysis has identified biomarkers of follicles~     still in their growth phase at trigger or follicles that have already begun luteinisation~     compare to follicle that are at the optimal level of differentiation. Measuring these~     biomarkers would allow making a better diagnostic for a given patient and potentially~     explaining reasons for failure. The system would also become adjustable to variable COS~     (control ovarian stimulation) and individual clinical practices. It is important to realize~     that this is applicable to almost all cycle failure and can be done on a pool of follicular~     cells when none of the oocytes obtained has led to a pregnancy. This does not resolve~     uterine problems but often these are caused by hormonal conditions established by the ovary~     or the ovarian treatment. This technology can be applied in all IVF clinics as no special~     equipment is required. It would be particularly valuable in clinics where a number of cycles~     is limited due to funding, or in clinic where a package of 3 cycles is proposed to the~     patient. The patient interest to have a custom treatment increases at each failing cycle as~     well as the doctors' interest to succeed. This technology is not clinically validated yet~     and would require a period of testing where participating clinics will collect the samples~     for a retrospective analysis (presence of biomarkers of follicular problems vs outcome) then~     in a prospective analysis where the diagnostic is used in a sub-set of patient to modulate~     the second/third cycle compared the outcome to patient with no diagnostic. The increase in~     pregnancy rate or cumulative pregnancy rate should reach a minimum of 10 and 25 %~     respectively to indicate a significant value.~   "
50423|NCT02397122|"~     The aim of the trial is to evaluate the effectiveness of coronally advanced flap~     (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II~     recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either~     with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque~     index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment~     level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization~     (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2)~     post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized~     tissue change (KTC) were also calculated.~   "
50424|NCT02397109|"~     The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a~     hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor~     muscles and the orbital fat.~      If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional~     contribution to the clinic, guiding the therapeutic management by detecting inflammatory~     lesions not found on clinical examination in 1/3 of cases.~      The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal~     analysis oculomotor abnormalities as well as the orbital fat.~      Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In~     addition, DIXON type of imaging overcomes most of these artifacts and to obtain a~     homogeneous fat removal.~   "
50425|NCT02397096|"~     The study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439~     [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected~     participants virologically suppressed on a protocol-specified antiretroviral regimen. The~     primary hypothesis is that a switch to MK-1439A will be non-inferior to continuation of the~     regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining~     HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study will last up to 50 weeks. An~     optional Extension Study will evaluate long-term efficacy and safety of the switch to~     MK-1439A for an additional 2 years.~   "
50426|NCT02397083|"~     The goal of this clinical research study is to learn if the Mirena intrauterine device~     (levonorgestrel IUD), alone or in combination with everolimus, is effective for the~     treatment of endometrial hyperplasia and/or early-stage endometrial cancer.~   "
50558|NCT02395354|"~     This study will be a multicentre randomized controlled trial to assess the efficacy between~     balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of~     stenosis in Crohn´s Disease.~   "
50427|NCT02397070|"~     This study evaluates the effect of jaw exercise therapy in the treatment of~     temporomandibular disorder patients (TMD). An eligible group of patients will be treated~     with that therapy (experimental group) and another group will be treated with counseling and~     occlusal splint (control group), considered the standard therapy for TMD.~   "
50428|NCT02397057|"~     This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled~     study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo~     on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12~     months. The subject's participation in the study will be for approximately 1 year from Day~     0.~   "
50429|NCT02397044|"~     The purpose of this study is to compare the success rates of two surgical protocols. One~     protocol will have the implants placed at the time of tooth extraction and placed into~     function. The other protocol will have the implants placed into healed extraction sites and~     placed into function.~   "
50430|NCT02397031|"~     The purpose of the study was to determine whether mindfulness training could be more~     effective than another active intervention in reducing borderline personality disorder (BPD)~     symptoms. The main hypothesis was that patients allocated to the mindfulness group would~     show a greater improvement on global BPD symptomatology. As a second objective, we explored~     some of the possible underlying mechanisms of both active treatments. For that purpose,~     changes in decentering, mindfulness facets and cognitive processing of social interactions~     were also evaluated.~   "
50431|NCT02397018|"~     This is a phase one study investigating the safety of a single, intravenous infusion of~     banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The~     cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will~     occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on~     post-stroke rehabilitation and functioning. A follow up clinic visit at 90 days will include~     a neurological exam, MRI, and blood tests.~   "
50432|NCT02397005|"~     The first-in-man study are designed as below to assess safety, tolerability, and preliminary~     pharmacokinetics of ZL-2102.~        -  Double-blind randomized, placebo-controlled ascending single oral doses (Part 1,~          ZL-2102-SAD);~        -  Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2,~          ZL-2102-FED);~        -  Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days~          (Part 3, ZL-2102-MAD).~      A total of 104 subjects will be enrolled.~   "
50433|NCT02396992|"~     The purpose of this study is to apply a minimal-massive intervention (minimal~     recommendations to maximal number of patients) to elderly (>70 years) hospitalized patients~     with oropharyngeal dysphagia (OD). The intervention will consist of early screening and~     assessment of OD, malnutrition and oral hygiene. Patients will be given recommendations for~     adaptation of volume and viscosity of fluids, nutritional support and good oral hygiene~     practices and followed at 3, 6, 9 and 12 months after discharge. In every point of the~     follow-up period, patients will be re-evaluated to adjust recommendations and to verify~     their compliance with the treatment.~      The objectives of the intervention are to have an impact on complications related to OD~     (avoid impaired safety alterations and improve nutritional and oral health status and~     reduce) and to reduce readmissions, readmissions for pneumonia and morbimortality.~   "
50434|NCT02396979|"~     The purpose of this study is to evaluate the relative impact a medical drug (methadone) or~     behavioral counseling program (Holistic Health Recovery Program) or both (methadone and~     Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit~     drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180~     days prior to leaving prison.~   "
50435|NCT02396966|"~     The purpose of the protocol is to evaluate and describe QoL, in the population of Polish~     acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term~     observation).~   "
50436|NCT02396953|"~     The objectives of the protocol is to determine the maximum tolerated dose and to investigate~     the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.~   "
50437|NCT02396940|"~     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD~     resolution in inguinal hernia repair in terms of error rating, performance time and~     subjective assessment.~   "
50438|NCT02396927|"~     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD~     resolution in cholecystectomy in terms of error rating, performance time and subjective~     assessment.~   "
50439|NCT02396901|"~     This is an randomised controlled trial to investigate an strategy based in a protocol in~     prevention of acute kidney injury after cardiac surgery.~   "
50440|NCT02396888|"~     Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface~     was applied daily with insulin and the other half with saline solution as placebo. Biopsy~     specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be~     evaluated as main outcome.~   "
50441|NCT02396875|"~     Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in~     patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve~     with the treatment which is both expensive and not without complication. Despite much~     research, we cannot accurately predict who will not respond. Furthermore, most heart failure~     patients gets symptoms on exercise and most studies have examined patients at rest. We~     propose to investigate the effect of exercise on different parts of the left ventricle by~     sampling various biomarkers of metabolism, myocardial injury and gene expression. We will~     then repeat the protocol following device insertion to look for changes. This novel work~     will require a small cohort of patients with heart failure and no electrical dyssynchrony~     and normal patients to act as controls. We will also measure novel biomarkers at different~     venous sites relating to different parts of the myocardium to determine whether they can be~     used to prognosticate or even predict response to CRT.~   "
50442|NCT02396862|"~     The purpose of the study is to improve the understanding of key patient reported outcomes~     such as quality of life as well as clinical outcomes in hemophilia A, in a global real world~     setting.~   "
50443|NCT02396849|"~     The purpose of this study is to see if the use of a machine called CPAP will help children~     with asthma breathe better. CPAP is a machine that produces airflow to help people with~     breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine.~     We believe that use of CPAP may be a treatment for children with asthma.~   "
50444|NCT02396836|"~     The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand~     rub technique in hand coverage and in reducing bacterial contamination on the hands of~     healthcare workers in practice.~      Research questions~        1. What is the effectiveness of the 6 step technique in hand coverage compared to the 3~          step technique?~             1. What are the most frequently missed sites in hand surface coverage using 6 steps~               compared to 3 steps?~             2. What is the reduction in bacterial contamination of the hand with the 6 step~               compared to the 3 step technique?~        2. Does site missed or coverage relate to bacterial load?~        3. What is the time taken for 6 step technique versus 3 step technique?~   "
50445|NCT02396823|"~     The proposed study is designed to answer a novel research question: Can resistive~     respiratory muscle training designed to improve respiratory motor control also improve blood~     pressure regulation impaired by spinal cord injury? Resistive breathing exercise, or~     respiratory muscle training, has been applied to rehabilitate breathing after spinal cord~     injury, but has not been evaluated as a method for increasing resting blood pressure and /~     or improving its regulation under stress as is planned in the proposed project. For the~     first time, respiratory muscle training intervention will be used as a tool to investigate~     the physiological relationships between pulmonary and cardiovascular function in individuals~     with Spinal Cord Injury (SCI). Thus, it will foster a new direction from which to address~     neglected issues surrounding the cardiovascular complications of spinal cord injury.~   "
50446|NCT02396810|"~     The investigators are studying the utility of intra-operative magnetic resonance imaging~     (iMRI) during transsphenoidal pituitary surgery by randomizing patients to either an~     intra-operative MRI after resection, or no intra-operative MRI. The investigators will then~     count the number of gross total resection in each group of patients and also the~     complications related to surgery.~   "
50447|NCT02396797|"~     Mental disorders is one of the most frequent causes of long-term sick leave and disability~     pensions in Norway, and there is a need for a comprehensive, coordinated response from~     health and social sectors at the country level to address the burden of mental disorders.~     The aim of this project is to investigate if a workplace intervention with the aim to~     increase coping of common mental health complaints and social support can reduce sick leave~     and improve health.~   "
50448|NCT02396784|"~     Early STOPP project promotes good health in children from early age by supporting good~     habits for the whole family. Our aim is to see if we can prevent overweight and obesity in~     children in families where parents are overweight or obese. Normal weight parents will also~     be needed in this study.~      Background: Several daily habits lead to less favorable health factors. For example, using~     the car instead of cycling or walking - leads to less activity in everyday life. Individuals~     also eat more unhealthy foods in larger portions. In combination with genetics, social in~     heritage and surrounding factors this contributes to increase overweight and obesity among~     children not only in adults but also in children.~      Good treatment for childhood obesity are lacking, making prevention very important. The~     earlier good habits are introduced to a child the better it is.~      In Early STOPP project we study food, physical activity and sleep habits in the families~     with a child of one year of age. The height, weight, waist circumference and blood pressure~     will be recorded in both child and parents. The parents will answer questionnaires about~     food, physical activity and sleeping habits for both the child and themselves. During the~     study, the child's physical activity will be measured. Based on our observations we aim to~     develop the preventive strategies for the families with very young children.~   "
50449|NCT02396771|"~     The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine~     compression after vaginal delivery with respect to blood loss and maternal pain. It is a~     randomized controlled trial that will be conducted at the American University of Beirut~     Medical Center - Delivery Suite.~   "
50450|NCT02396758|"~     The objective of the study is to determine the optimum dose of thrombolytic and duration of~     the ultrasound procedure as a treatment for acute submassive pulmonary embolism.~   "
50451|NCT02396745|"~     This study will test the safety and effectiveness of esophageal transoral endoscopic~     circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat~     Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential~     resection using ECM placement has been introduced as a less invasive, externally~     incision-less approach to treat patients with esophageal high grade dysplasia; a~     pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa~     (esophagus lining) will be removed using an endoscope that will be inserted through the~     mouth. The ECM will be placed over the area that is being removed with a temporary,~     expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the~     ECM in place as the body begins the healing process. This stent will be removed 14 days (±4~     days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow~     x-ray tests, and questionnaires will take place for 12 months following the procedure. The~     result of this study may help doctors determine if this procedure would be a more effective~     treatment option for HGD in the future.~   "
50452|NCT02396732|"~     The purpose of this study is to determine if the addition of antiplatelet therapy (i.e.~     aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of~     venous thromboembolism (VTE) in high-risk critically injured patients. The investigators~     further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and~     enoxaparin for decreasing the incidence of VTE after trauma.~   "
50453|NCT02396719|"~     The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond~     laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.~   "
50454|NCT02396706|"~     Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety~     of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough~   "
50455|NCT02396693|"~     Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome~     in an attempt to assist failure extubation. The investigators investigated failure~     extubation in infants gestational age less than or equal to 34 weeks and weights less than~     or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101~     newborns were included in this study in three groups , group 1: Nasal Intermittent Positive~     Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure~     Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble~     Ventilator (NCPAP ventilator) (n=32)~   "
50457|NCT02396667|"~     5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine~     estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by~     ultrasound will be compared to actual birth weight.~   "
50458|NCT02396654|"~     5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation~     and fetal weight will be estimated using the hadlock formula using biometry measured by both~     ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.~   "
50459|NCT02396641|"~     The primary objective of this study is to formalize the delivery of BSC in advanced cancer~     trials. The first aim (to develop expert-derived consensus statements regarding components~     of supportive care in cancer clinical trials) and the second aim (to compare the extent to~     which documentation of current supportive care delivery in trials compares to the consensus~     statements) have been completed. The final aim of this study is to test the feasibility of~     thorough documentation of BSC delivery. That work is proposed as the primary aim of this~     study.~   "
50460|NCT02396628|"~     The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory GvHD.~     The investigators therefore intend to launch a clinical phase 2 trial. In this multicenter~     phase 2 trial the investigators will evaluate the efficacy of Ruxolitinib in~     Steroid-refractory acute GvHD in up to 15 transplantation centers. The investigators will~     evaluate the response by monitoring the clinical GvHD grade, requirement of alternative GvHD~     active agents and serum levels of pro-inflammatory cytokines. Until now, there is no report~     of GvHD patients treated with JAK1/2 inhibitors and the investigator don't have the evidence~     for a coexisting trial that investigates the activity of JAK1/2 inhibitors in GvHD~   "
50461|NCT02396615|"~     The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red~     ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the~     short-term.~   "
50462|NCT02396602|"~     Using our experience in digital media, behavior theory, client-centered interventions, and~     family planning, we have prototyped a digital application (app)—miPlan—to be used in the~     clinic waiting room prior to a contraceptive visit. The goal of this research is to refine~     the app and conduct a randomized controlled trial of the miPlan intervention vs. standard~     care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC~     uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge,~     self-efficacy and decisional balance for highly effective contraception post-app use,~     contraceptive satisfaction, and intention to continue method use. The research will consist~     of baseline activities as well as a three-month follow-up call.~   "
50463|NCT02396589|"~     Stroke is one of the most serious, disabling health conditions in the United States.~     Patients who undergo rehabilitation treatment for stroke have a high rate of disability.~     Poor outcomes for many persons with stroke may be low because of incomplete treatment. The~     investigators will conduct a randomized controlled trial and a process evaluation to examine~     the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition~     program, Community Participation Transition after Stroke (COMPASS), designed to bridge~     inpatient rehabilitation and the home to support the performance of everyday activities.~   "
50464|NCT02396576|"~     In partnership with a multi-site, Los Angeles-area community clinic consortium, North East~     Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate~     pediatric developmental, behavioral and mental health (DB/MH) services into primary care for~     low-income, publicly insured children. During Project Year 1, the investigators used~     qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at~     NEVHC to assess their perspectives on the delivery of child DB/MH services and on a~     potential telehealth-based patient visit, coordination, and clinician education system for~     the provision of DB/MH specialty care in primary care settings to children ages 5-12. This~     data was used in a stakeholder-engaged process to customize a telehealth-based delivery~     system for pediatric DB/MH services that can be integrated into primary care settings.~      During Project Years 2-3, the investigators will conduct a cluster randomized controlled~     trial (RCT) to compare the customized telehealth-based patient visit, coordination, and~     clinician education system to the usual in-person, community- based referral system at~     NEVHC. This study will examine whether a telehealth developmental, behavioral and mental~     health delivery model can be an effective, efficient, and family-centered way to provide~     integrated DB/MH services to children in low-income communities.~   "
50465|NCT02396563|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first and second stage of labor in nulliparous women , with or without epidural analgesia.~     The investigators hypothesize that the duration of the first stage of labor will be no~     different in nulliparous patients, while the duration of the second stage will be longer in~     patient with analgesia.~   "
50466|NCT02396550|"~     Lateral epicondylalgia affects people of both gender between 1 and 3% of the world~     population, with up to 15% in the working population reaching an average of 12 weeks off~     work for this reason. One of the conservative treatments that have shown effective is the~     mobilization with movement, whose mechanisms of action are not known. According Bialosky et~     al., possible effects of manual therapy are based on the neurophysiological mechanisms at~     peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the~     placebo effect, which is influenced by psychological factors such as conditioning and~     expectations.~      Changing expectations to determine the influence on the treatment has been studied in~     healthy subjects, showing improvement with positive expectations and worsening to negative~     and neutral expectations.~      However the result of modifying the previous expectations for treatment in patients with~     pain has not been studied.~      The aim of our study is to test the influence that positive expectations have on the~     effectiveness of treatment with mobilization with movement in patients with lateral~     epicondylalgia.~   "
50467|NCT02396537|"~     The purpose of this study was to establish whether premedication with topical lidocaine~     would reduce the pain associated with IN midazolam administration in children. The study was~     designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban,~     academic pediatric emergency department.~   "
50543|NCT02395549|"~     This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in~     subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice~     daily (bid) for 12 weeks and compared against a vehicle control.~   "
50468|NCT02396524|"~     The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical~     fitness, eating habits and health-related lifestyle choices through a lifestyle modification~     program in collaboration with two Ontario Hockey League teams. In this pilot pragmatic~     randomized controlled trial, the investigators plan to explore the potential for Hockey FIT~     to reduce a clinically important amount of weight, increase physical activity levels, and~     lead to improvements in other health-related outcomes.~   "
50469|NCT02396511|"~     The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is~     effective in the treatment of one patient with metastatic and refractory choriocarcinoma.~   "
50470|NCT02396498|"~     The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic~     intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy~   "
50471|NCT02396485|"~     After institutional review approval, pregnant women that are scheduled for elective cesarean~     delivery will be approached for participation in the study. The study informed consent will~     be obtained. The study's time frame inclusive will be from 2013 till 2016.~      Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus~     remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced~     as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the~     investigators' institution.~      Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length~     of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be~     performed using a computer generated random list of numbers assigning patients to the 2~     groups of the study. This list of random number assignments will be kept secure in an opaque~     envelope until the end of the study. Patients in the Early group will be started on regular~     diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO~     12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as~     tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will~     be started on solid foods. If diet not tolerated, a full liquid diet will be given instead.~     Consequently if patient tolerated full liquid diet, a regular diet will be then initiated.~     Patients will be discharged home only if they tolerate solid food with absence of emesis,~     have flatus or bowel movement. Time Zero is defined as time of skin incision.~   "
50472|NCT02396472|"~     People facing serious health threats increasingly use Internet health support communities to~     obtain informational support, emotional support and other resources. This study introduces~     software algorithms similar to those used by social media sites to put people in touch with~     helpful information and social interactions. Participants from the American Cancer Society's~     Cancer Support Network will have access to this online support group using the default~     interface that orders content by broad content category and date or with a new interface~     that highlights communication content and people that match users' interests and needs.~   "
50473|NCT02396459|"~     Triac Trial II will assess the effects of Triac therapy on several neurocognitive end-points~     in patients with the Allan-Herndon-Dudley Syndrome (AHDS).~      Patients with the AHDS suffer from severe psychomotor retardation. A mutation in the TH~     transporter protein Monocarboxylate transporter 8 (MCT8) results in reduced thyroid hormone~     (TH) levels in de brain, leading to an impaired neuronal differentiation. The severe~     neurological phenotype is accompanied by increased T3 levels in the blood, resulting in a~     variety of thyrotoxic symptoms such as tachycardia, increased metabolism, weight loss and a~     low muscle mass.~      Currently, Triac Trial I (NCT02060474) investigates if Triac treatment in AHDS patients~     reduces the toxic effects of the high T3 levels. In addition, the safety of Triac~     administration in AHDS patients is assessed.~      In Triac Trial II we will focus on the effects of Triac on the neurocognitive development.~   "
50474|NCT02396446|"~     This study is being conducted to determine whether providers who have access to their~     patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that~     continuously monitors bowel sounds (AbStats) will be more likely to advance their patients'~     diets to a solid diet sooner than those who do not have access to this rate. AbStats~     calculates intestinal rates by using two small sensors placed on a patient's abdomen to~     measure and analyze their abdominal sounds.~      Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting~     daily during their inpatient visit. The sensor will measure the sounds within their abdomen.~     This data will be interpreted by the AbStats device, which will provide an intestinal rate~     measurement based on the sounds recorded by the sensors.~      This intestinal rate will be provided to the patient's treating physician together with~     other vital signs. The doctor, at his/her discretion, may choose to use this information to~     make decisions about the patient's feeding status.~   "
50475|NCT02396433|"~     Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the~     combination of carboplatin, eribulin, and E7449.~   "
50476|NCT02396420|"~     The purpose of the study is to evaluate improvement in symptoms related to benign prostatic~     hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere~     Microspheres.~   "
50477|NCT02396407|"~     The purpose of this study is to measure whether a combined water, sanitation, and hygiene~     intervention leads to improved health of children who did not receive the intervention~     themselves and who live within a close vicinity of intervention recipients.~   "
50478|NCT02396394|"~     WiseMama is designed to improve our understanding of interventions that are feasible and~     effective in helping HIV-positive pregnant and postpartum women to maintain high adherence~     to antiretroviral medications. The study will involve: a) assessing the feasibility and~     acceptability of the use of an innovative pill container equipped with real-time electronic~     data monitoring capacity by HIV positive pregnant and postpartum women in Uganda; b)~     generating preliminary effectiveness data of a 2-step feedback intervention on retention in~     care, antiretroviral therapy adherence, and clinical outcomes (CD4 and HIV viral load (VL));~     c) exploring patient and provider perspectives on barriers and facilitators to retention in~     care and adherence to antiretroviral therapy in our study population.~   "
50479|NCT02396381|"~     The aim of the study is to demonstrate clinical, biological and functional health changes in~     smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2~     (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over~     a 26-week period.~   "
55665|NCT02328521|"~     The investigators aim to investigate the effect of oral nicorandil on neointima after~     coronary drug-eluting stent implantation in patients with diabetic mellitus.~   "
50480|NCT02396368|"~     This is a Phase I/Ib study of Radium-223 in combination with Tasquinimod for patients with~     bone metastases from castration-resistant prostate cancer (CRPC).~      The investigators propose to determine the spectrum of tolerability of the combination of~     tasquinimod and radium-223 and determine a dose for a subsequent randomized phase II study~     (first cohort) and the proportion of men with bone-specific alkaline phosphatase response~     (second cohort).~   "
50481|NCT02396355|"~     The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the~     immune status of patients with, or suspected of developing, immune deficiencies such as~     AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use~     in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes,~     and hemoglobin (Hb) concentration in human whole blood.~      This is a prospective study to determine the relative bias between the investigational BD~     FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their~     determination of absolute CD4, % CD4, and Hb concentrations.~   "
50482|NCT02396342|"~     This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients~     with severe or moderately severe hemophilia B and severe bleeding type.~   "
50483|NCT02396329|"~     There is no difference between using chlorhexidine-based antisepsis protocol versus~     povidone-iodine protocol in reduction of surgical site infection in women undergoing~     cesarean section.~   "
50484|NCT02396316|"~     To assess the efficacy and safety of the administration of aflibercept by intravitreal~     injection in comparison to sham to control intraocular pressure in patients with neovascular~     glaucoma.~   "
50485|NCT02396303|"~     Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly~     one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the~     causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and~     caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be~     prevented. But, the incidence and especially its magnitude can be reduced by assessing the~     risk factors and following the guidelines. The intelligent anticipation, skilled~     supervision, prompt detection and effective institution of therapy can prevent a normal case~     from undergoing disastrous consequences. This study will be carried out at Bangabandhu~     Sheikh Mujib Medical University (BSMMU) within six months after approval. This is a~     Randomized Control Trial which will compare efficacy of Carbetocin and Oxytocin for the~     control of PPH. Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient~     chart, operation notes, surgeons visual estimation of blood loss etc will be used as study~     tool. Ethical clearance will be obtained from Institutional Review Board of BSMMU. Written~     informed consent will be obtained from the patient or from her legal guardian. Patient~     confidentiality will be strictly maintained. No name, address or contact details of the~     patient will be divulged.~   "
50486|NCT02396290|"~     Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar~   "
50487|NCT02396277|"~     Immobilization after radius fracture seems to increase the risk of developing a Complex~     regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity~     and reduced epidermal nerve density.~      The purpose of the study is to determine whether 5-week immobilisation leads to functional~     and structural sensory changes, and whether the changes are associated with persistent pain.~     The investigators plan an explorative, pilot study on six consenting patients immobilised~     after a distal radius fracture.~      The baseline measurements will be recorded at the day of or the day after trauma:~     Demographics, psychological and physical comorbidity, pain characteristics and intensity,~     hand function, health related quality of life (HRQOL), quantitative sensory testing will be~     recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following~     variables such as pain characteristics and intensity, hand function, health related quality~     of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is~     removed and two months later.~   "
50488|NCT02396264|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged~     women characterized by chronic anovulation, hyperandrogenism and insulin resistance.~     Available guidelines recommend lifestyle intervention although they do not suggest the best~     dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare~     the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized~     normocaloric Diet in normal weight women with PCOS.~   "
50489|NCT02396251|"~     A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study~     is designed to assess efficacy with regard to aesthetic midface augmentation and safety~     after treatment with HA product.~   "
50490|NCT02396238|"~     The primary objective of this study is to assess the safety and efficacy of the Celution~     Device in the processing of an autologous graft consisting of adipose derived regenerative~     cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.~   "
50491|NCT02396225|"~     Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are~     compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of~     voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day,~     respectively.~   "
50492|NCT02396212|"~     This is a phase III study designed to provide efficacy and safety data for canakinumab~     administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in~     Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)~     data at Week 28 and 48 from this study will support a registration submission of canakinumab~     in the indication of SJIA in Japan.~   "
50493|NCT02396199|"~     The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety~     and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium~     iCAST™ covered stents in the treatment of abdominal aortic aneurysms.~   "
50494|NCT02396186|"~     The purpose of this study is to collect data from real-world use with the Glider~     Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the~     effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.~   "
50518|NCT02395874|"~     To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech~     therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients~     will be randomized by a computer-generated lot. Assessment will be performed at study onset,~     after six weeks at the end of the specific intervention and 4 months after stroke onset for~     follow-up.~   "
50495|NCT02396173|"~     Background: Orthopaedic trauma are a leading cause of long-lasting sick-leave and persistent~     disability. People suffering from persistent sick-leave often need vocational rehabilitation~     (VR). Vocational programs are planned to improve the likelihood of returning to work (RTW).~     Physical conditioning, professional evaluation and training, as well as psychological and~     social interventions are the core of the treatments. Efficiency of these programs is~     moderate and there is scope for improvements. For instance, rehabilitation programs tailored~     to the individual needs and potentials are called for. However, the allocation remains~     difficult. Decision-supportive tools may be convenient to achieve this goal. Recently, the~     WORRK model was proposed to assess early on the risk of non-returning to work for those~     patients. The main goal of this research is to measure if the WORRK model improves patients'~     allocation to different vocational programs according to their non-return to work risk.~   "
50496|NCT02396160|"~     This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control~     over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being~     recruited, randomized and administered treatment or placebo for the period of 8 weeks after~     initial eligibility screening. Outcome measures include previously validated tools such as~     the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and~     incontinence episodes. Quality of life improvements are being measured using the~     Incontinence Impact Questionnaire, Urinary Distress Inventory and the short version of the~     OverActive Bladder survey.~   "
50497|NCT02396147|"~     The purpose of this study is to evaluate the oral bioavailability of two new tablet~     formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed~     conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the~     pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4~     Formulation C tablet.~   "
50498|NCT02396134|"~     This randomized phase II trial studies how well vaccine therapy works in reducing the~     frequency of cytomegalovirus severe infections (events) in patients with hematologic~     malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help~     the body build an effective immune response and may reduce cytomegalovirus events after~     donor stem cell transplant.~   "
50499|NCT02396121|"~     The purpose of this study is to evaluate the micronutrient status of malnourished elderly~     after oral nutritional supplementation.~   "
50500|NCT02396108|"~     The current standard of care for stage I-III HER2-positive breast cancer is adjuvant~     chemotherapy combined with 1 year of adjuvant trastuzumab. Neoadjuvant chemotherapy in early~     stage breast cancer has the advantages of i) tumour downsizing, ii) higher breast~     conservation rates, and iii) enabling the evaluation of tumour biology. Pathologic complete~     response following neoadjuvant chemotherapy has been shown to be an independent, strong~     predictor of outcome in operable HER2-positive breast cancer. The addition of neoadjuvant~     anti-HER2 therapy to chemotherapy results in a 2-3 fold increase in pCR rates in operable~     HER2-positive breast cancer. However, the optimal neoadjuvant regimen has not been defined~     in HER2-positive breast cancer. The investigators recently completed a phase II study of~     neoadjuvant lapatinib combined with weekly paclitaxel/ carboplatin in stage I-III~     HER2-positive breast cancer. Preliminary analysis suggested that the utility of the regimen~     might have been limited by its unfavourable efficacy/ toxicity ratio. ASLAN001 is a small~     molecule tyrosine kinase inhibitor against HER1, HER2, and HER4. Preclinical data have shown~     ASLAN001 to be more potent than lapatinib and neratinib in inhibiting HER1 and HER2, and~     early phase clinical studies have demonstrated superior pharmacokinetics and pharmacodynamic~     target inhibition compared to lapatinib. Furthermore, ASLAN001 has demonstrated a better~     safety profile than lapatinib in early phase studies.~      • The investigators hypothesize that ASLAN001 combined with paclitaxel/carboplatin will~     induce favorable pathological complete response (of at least 30%) in stage I-III HER2~     positive breast cancer, with a more favourable safety profile than lapatinib combined with~     paclitaxel/carboplatin.~   "
50501|NCT02396095|"~     Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be~     eligible to participate in a study investigating pregnancies that result from frozen eggs.~   "
50502|NCT02396082|"~     This is a 24-month, prospective, single- blind, randomized controlled trial evaluating the~     MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort~     of 300 community-living persons with dementia and their family caregivers in the Greater~     Baltimore area. Participants receiving MIND-S will get 18 months of care coordination by an~     interdisciplinary team comprised of trained memory care coordinators (non-clinical), a~     psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components:~     identification of needs and individualized care planning (persons with dementia (PWD) and~     care giver (CG) needs); dementia education and skill building; coordination, referral and~     linkage of services; and care monitoring.Participants in the comparison group will receive~     an initial in-home needs assessment and will be given the written results along with any~     recommendations for care that are indicated.~   "
50503|NCT02396069|"~     Double blind, randomized, placebo control, multiple dose, dose escalation study~   "
50504|NCT02396056|"~     Guided bone regeneration (GBR) procedures have significantly evolved over the last 20 years.~     Significant advances have been made with various barrier membranes with or without the use~     of bone grafts and other materials. Some of the main limitations of non-resorbable barriers~     included cytotoxicity and need for removal, which can adversely affect the regenerated bone~     volume. Similar GBR success has been documented extensively with cell occlusive resorbable~     barriers membranes. Recently, the investigators demonstrated supracrestal bone regeneration~     in guided tissue regeneration procedures in humans with the use of novel perforated barrier~     membrane (MPM). The perforation allows mesenchymal stem cells and other progenitor cells~     present in the gingival tissues to migrate into the osseous defect and contribute to the~     osseous regeneration potential.~      The objective of this study is to investigate the GBR potential of MPM in alveolar ridge~     defects, relative to a similar occlusive barrier. Ten non-smoking patients that need~     localized alveolar ridge augmentation prior to implant placement will be included into the~     study. Patients will be divided into two groups, as follows: occlusive bovine collagen~     membrane (OM control group, 5 patients) and modified bovine perforated collagen membrane~     (MPM test group, 5 patients). All sites will be grafted with mineralized cortical bone~     allograft and when needed cortical bone pins will be use for site stability. A Cone Bean~     (CT) will be obtained prior to surgery and 6-8 months post treatment from which volumetric~     width changes will be quantify. A bone biopsy will be obtained at the time of implant~     placement (~6-8 months) to determine residual graft particles and new bone formation.~     Dimensional width changes will be assess at 6-8 months during re-entry for implant~     placement. Soft tissue healing will be assessed at 2, 4, 8, 16 weeks and 6 months.~      This study can potentially impact current bone augmentation techniques and may lead to the~     modification of existing commercial membranes that will enhance site development prior to~     implant placement. The contribution of progenitor cells to the osseous defect might lead to~     greater bone formation and possible faster wound healing.~   "
50505|NCT02396043|"~     This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma~     (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.~   "
50506|NCT02396030|"~     Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures,~     there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are~     still questions regarding its use and dose. The scheme and the optimal time of~     administration remain to be elucidated. The objective of this trial is to compare the~     effectiveness and safety of intravenous magnesium sulfate in the maintenance phase 1g / h~     versus 2 g / h to prevent eclampsia in pregnant and postpartum women with severe~     preeclampsia (pure or superimposed).~   "
50507|NCT02396017|"~     To compare the small bowel cleanliness for wireless capsule endoscopy using two different~     Polyethylene Glycol administration schedules (before the wireless capsule endoscopy~     ingestion versus in a split-dose fashion).~   "
50508|NCT02396004|"~     Aim of study:~      To conduct an observational study to collect cerebral and renal perfusion data through NIRS~     before and after treatment of PDA by medication or by PDA ligation. The data post treatment~     would form the basis for normative baseline data in VLBW preterm newborn babies,~     particularly in the Asian population.~      Study population/inclusion criteria:~      VLBW newborn babies with hemodynamically significant PDA by echocardiography.~      Exclusion criteria:~      Major malformations Moribund patients~   "
50509|NCT02395991|"~     The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA~     administration by obtaining continuous dynamic T1 weighted image data.~   "
50510|NCT02395978|"~     The purpose of this study is to evaluate the safety and efficacy in patients with major~     depressive disorder.~   "
50511|NCT02395965|"~     The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and~     safety of osteopathic manipulative treatment (OMT) using data collected from patients~     receiving OMT in the clinical setting within the established practice-based research network~     DO-Touch.NET.~      . The HYPOTHESES of this research study are the following:~        -  OMT is primarily used in the treatment of musculoskeletal pain disorders.~        -  Patients receiving OMT will have decreased symptoms and improved quality-of-life.~        -  The most common side effect reported by patients receiving OMT will be muscle soreness.~   "
50512|NCT02395952|"~     The purpose of this study is to compare the relative efficacy of four different treatment~     modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane,~     Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following~     retina surgery.~   "
50513|NCT02395939|"~     Obtaining a tissue sample to diagnose a PPL suspected of cancerous origin is of utmost~     importance. The current gold standard; Transthoracic CT guided needle biopsy approach with a~     success rate of >90% comes at the expense of an increased side effect profile.~      Given that most lung cancers originate in the bronchus, hence named bronchogenic~     carcinoma, it would be rational to think that endobronchial route should provide the best~     route of sampling with the least amount of side effects. Radial EBUS has become popular~     during the last decade as an endobronchial modality in diagnosing PPL with minimal side~     effects. However, the yield is still not satisfactory in comparison to CT guided biopsy with~     only 73% success rate in a meta-analysis. There is also with wide variation in different~     centres.~      Use of a new biopsy method called cryo-biopsy using the R-EBUS guide sheath may bridge the~     gap and increase the diagnostic yield of PPL.~      Cryo biopsy had been proven to give larger sample sizes and reduced crush artefact compared~     to the conventional radial EBUS biopsies.~      However, there have been no head to head trials comparing Cryo-probe biopsy vs. the gold~     standard: CT guided biopsy.~      Cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence. If~     the yield were to be non-inferior to CT guided biopsy this would certainly be the preferred~     choice of biopsy for PPL in the future.~      Methodology All patients with a PPL requiring a diagnostic biopsy will be eligible for~     recruitment to the trial. The recruited patients will be randomly allocated to either CT~     guided core biopsy or radial EBUS guided cryobiopsy.~      Study design Multi centre intervetional,randomised control trial.~      Study population:~      Patients diagnosed with a PPL that requires a biopsy.~      If the patient is randomised to the cryo biopsy arm:~      The procedure will be done under the usual guidelines and practice of the centre as for a~     flexible bronchoscopy procedure.~      Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is~     inserted covered by the GS.~      Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.~      The cryoprobe is then inserted through the GS to the desired location. Flexible Cryoprobe~     (outer diameter 1.9mm) will be applied for 4 seconds for each biopsy. The cryogen gas used~     will be Co2.~      The probe will be retracted together with the GS and the bronchoscope en masse after each~     biopsy. A minimum of 1 and maximum of 3 samples will be taken.~      A CXR is taken within 1 hour post procedure to access for pneumothorax. Adverse events~     during the procedure will be recorded. If a chest tube placement, other investigations due~     to side effects or overnight hospital stay were to be required; all costs will be calculated~     retrospectively. Minor bleeding will not be considered an additional cost as this occurs~     with routine bronchoscopy.~      If the patient is randomised to the CT biopsy arm:~      A CT guided core biopsy will be performed as per usual practice of that centre. 2-6 passes~     will be performed for each PPL.~      A CXR 1hour post procedure will be performed to assess for pneumothorax or procedure related~     bleeding.~      If a chest tube placement, other investigations due to side effects or overnight hospital~     stay were to be required all costs will be calculated retrospectively.~      At the pathology:~      All samples will be assessed for the size of the sample and the suitability for molecular~     testing. An independent pathologist will assess samples.~      Economic analysis:~      For both procedures: Both direct and indirect costs will be calculated. The main aim of cost~     analysis is to calculate the cost of side effect management in each arm to determine the~     most cost-effective method of sampling a PPL.~   "
50514|NCT02395926|"~     Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the~     brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure~     and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine~     glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell~     membrane play and acetylcholine receptor function secondary symptoms caused by~     cerebrovascular deficiency and indirectly through activation of metabolism, has a~     degenerative effect on the brain organic mental syndrome.~      Currently marketed oral choline alfoscerate received a geriatric cognitive impairment,~     secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for~     degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin~     soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when~     considering optimal convenience and efficiency of the drug in patients with the development~     of sustained release formulations that can be maintained for a long period of time, a~     certain concentration is required. Accordingly, the modern drug by reducing the frequency of~     administration a day circuit is to develop a sustained release formulation of choline~     alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a~     time (600 mg x 2) can be taken one day to 1200 mg is required by taking.~      Therefore, for the development of sustained release formulation, the test in healthy adult~     male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1~     day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and~     safety of a single dose should be evaluated when compared.~   "
50515|NCT02395913|"~     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when~     orally administered as a salt composed of an acid-base as a compound that was synthesized by~     and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively~     applied to the bronchial or lung tissue and inhibit the activity of phospholipase~     bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar,~     leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent~     anti-inflammatory activity, bronchial was celebrated by reducing the bronchial~     hyperreactivity to normal state is allowed to recuperate or extended.~      It was developed to improve compliance improve pharmaceutically Surfolase~     capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline~     200mg) that intake once daily 200mg~   "
50516|NCT02395900|"~     To study the effects of Flaxseed supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50~     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be~     randomly allocated to receive placebos or 30 grams Flaxseed powder for 12 weeks; both groups~     will be advised to adherence the investigators' diet and exercise program too. At the first~     and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers,~     and liver fibrosis will be assessed and compared between groups.~   "
50517|NCT02395887|"~     High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of~     'neurogenic claudication' which effects postural balance and stability. If conservative~     treatment fail to improve symptoms, an invasive treatment which includes spinal~     decompression can be done.~      The research is an observational prospective one, pre and post operational intervention. The~     aim is to examine whether an operational intervention improves quality of life, pain,~     postural balance an stability among patients.~      It's important to clarify, that although there is operational intervention, the research is~     observational. The decision weather to operate or not, is not a part of the research. The~     investigators assume that since there is a population that independently going through an~     operation, the investigators can observe this population and evaluate different aspects of~     the operation outcomes.~   "
50539|NCT02395601|"~     First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in~     patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.~   "
50519|NCT02395861|"~     Severe diseases in intensive care unit (ICU) patients are associated with a high mortality~     rate which nevertheless remains difficult to predict. Recently, the abolition of some~     brainstem reflexes at clinical examination of ICU patients within the first 24 hours after~     has been shown of prognostic value in ICU patients requiring sedation. Early abolition of~     the cough reflex was associated with an increase in mortality and that of the oculocephalic~     reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of~     the brainstem may account for these results and be present in other patient subpopulations,~     particularly those who do not receive iv sedation or the brain injured patients, who were~     eluded from the previous study. This dysfunction could take place in the muti-organ failure~     characteristic of the severe ICU patient. On the other hand, a preliminary study performed~     on somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16~     ms between day 1 and day 3 after admission was associated with death at 28 days. The primary~     goal of this project is to confirm this hypothesis. By studying the clinical and~     electrophysiological responses of the brainstem in ICU patients, with or without brain~     injury, with alteration of consciousness in relation or not with sedation. The other~     objectives are to determine the correlations between neurophysiological clinical~     neurological, or neuroradiological data with delirium occurrence.~      The main objective of this study is to determine, in ICU patients with or without brain~     injury and with alteration of consciousness in relation or not with sedation, if abolition~     of the cough reflex at Day 1 after admission is predictive of mortality at 28 days,~     independent from cause for admission and severity.~   "
50520|NCT02395848|"~     This is a medical research study designed to look at the safety and efficacy of 30-day~     course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI~     is an infection that results when the normal flora (resident bacteria) of the colon is~     substantially altered by antibiotic treatment. The decrease in this normal flora allows for~     the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by~     Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode~     of recurrent CDI have been studied using a 10-day course of fidaxomicin.~   "
50521|NCT02395835|"~     The main objective of this study was to assess whether clinical, anthropometric, and~     biochemical variables of the mother were associated with changes in the methylation of the~     PPARg promoter region (-351 to -260). Methodology: This was a matched cohort study with two~     groups: a) normal weight (NW) pregnant women (n = 21) and their offspring, and b) overweight~     (OW) pregnant women (n = 20) and their offspring. DNA was extracted from leukocytes~     (4000-10,000 cells) in the MagnaPure (Roche) using the MagNAPure LC DNA Isolation Kit 1~     (Roche, Germany). The treatment of DNA (2 µg) was performed with sodium bisulfite (EZ DNA~     Methylation-Direct Kit, ZymoResearch). Real-time polymerase chain reaction (qPCR) was~     performed in a LightCycler 2.0 (Roche) using the SYBR® Advantage® qPCR Premix Kit~     (Clontech).~   "
50522|NCT02395822|"~     A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in~     adults and subcutaneous IL-15 given after a preparative regimen for the treatment of~     relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study~     the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining~     safety.~   "
50523|NCT02395809|"~     Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are~     compared with a healing rate over 92%. However, the most serious complication of this~     procedure is anal incontinence. To overcome these problems, continued efforts are being~     tried to find less invasive treatments modalities for anal fissure that is as effective as~     surgical therapy with lower morbidity.~   "
50524|NCT02395796|"~     Epidural analgesia is highly effective for labor pain relief and is widely chosen by~     pregnant patients. However, placement of the epidural needle can be challenging in pregnant~     patients due to lax tissue ligaments and edema so that the traditional loss of resistance~     method (LOR) used to find the space may be subtle leading to retries which may delay onset~     of analgesia as well as increase the risk of complications. The ability to transduce a~     pulsatile pressure waveform from epidural needles placed in non-laboring patients correlates~     highly with successful placement of the epidural needle. We wish to evaluate the efficacy of~     obtaining a pulsatile pressure waveform with correct epidural needle placement in laboring~     women.~   "
50525|NCT02395783|"~     Neurocognitive sequelae observed in preterm represent a major health problem for which there~     is no preventive treatment approved to date. These effects are the result of a~     multifactorial brain damage occurring in developing prenatal and perinatal period.~     Melatonin, the principal hormone secreted by the pineal gland has neuroprotective properties~     in various experimental animal models of perinatal brain damage level. This hormone readily~     crosses the placental barrier, its antenatal administration would have a neuroprotective~     effect in the case of preventive preterm birth before 28 weeks of amenorrhea.~      The objective of this study determine the dose of melatonin administered parenterally in~     prenatal maternal in preterm labor to reduce brain damage in the white matter detected by~     diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical~     term of 40 weeks in children born prematurely.~   "
50526|NCT02395770|"~     Objectives: Evaluate the effects of a rehabilitation program based on movement training on~     symptoms, functional limitations and acromiohumeral distance (AHD) in individuals with SPS.~      Methods: Twenty-five participants with SPS participated in a 6-week program. Outcomes of~     both groups were evaluated at baseline and 6 weeks. Changes in symptoms and functional~     limitations were assessed. Changes in AHD for both groups were assessed using~     ultrasonographic measures.~   "
50540|NCT02395588|"~     This study will test if standardized care helps patients feel better, if it can be~     implemented in rural hospitals, and find out which healthcare processes and outcomes are~     most important to heart failure patients.~   "
50541|NCT02395575|"~     The primary objective of this study is to evaluate the impact of the result of the Prosigna~     Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone~     therapy) in patients suffering from early-stage breast cancer.~   "
50542|NCT02395562|"~     Several studies show that the incidence of skin cancer parallels the length and depth of~     immunosuppression. This study will analyze the correlation of viral reactivation and skin~     cancer in organ transplant recipients.~   "
50557|NCT02395367|"~     The aim of the study is to construct a register system of oral and maxillofacial malignant~     tumors based on a prospective, observational, real-world study in north Chinese population.~   "
50527|NCT02395757|"~     Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the~     central region of the retina responsible for discrimination between high spatial frequencies~     (reading), colour vision and the central visual field. The loss of visual acuity which~     occurs with the onset of AMD significantly affects patients' quality of life. In developed~     countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its~     prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million~     people suffer from this disease.~      In the first stage of the disease it is known as age-related maculopathy (ARM). This early~     form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification)~     and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of~     exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's~     progression.~      It is therefore vital to adopt a strategy to assess the stage of the disease and provide the~     appropriate care management at the earliest possible stage. This is even more important for~     patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of~     the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%.~      Microperimetry is a promising new diagnostic method which combines measurements of light~     sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the~     functional assessment of retinal damage in patients with AMD, as it precisely correlates~     anatomical and functional modifications by measuring the loss of sensitivity and macular~     fixation. It has been shown that the more advanced the patient's AMD is, the further the~     parameters measured by microperimetry are from the norm.~      The investigators want to assess the MAIA™ as a means of screening for AMD progression in~     patients with a high risk of progressing to a more advanced stage (patients presenting one~     eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS~     classification). The research hypothesis for our proposed study is that the parameters~     measured using microperimetry will already show abnormal results in the study eye prior to~     progressing to a more advanced stage of the disease. The use of these microperimetric~     parameters as predictor of progression would therefore make it possible to screen eyes~     likely to develop from intermediate to advanced AMD at an earlier stage, and subsequently~     provide patients who need it with earlier follow-up, preventive treatment or adapted,~     personalized rehabilitation as appropriate.~   "
50528|NCT02395744|"~     The purpose of the COPPER - B study is to assess the feasibility, safety, and initial~     efficacy of paclitaxel administration using the OPC for the prevention of restenosis in~     infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the~     OPC.~   "
50529|NCT02395731|"~     This Center for Medicare and Medicaid funded health care innovation award will implement the~     MIND at Home dementia care coordination program (called MIND at Home-Plus) through two~     community-based service agencies (Jewish Community Services, Johns Hopkins Home Care Group)~     to rapidly improve the ability of 600 dually eligible older adults with dementia in the~     Baltimore region to remain at home while improving care quality, enhancing quality of life,~     and reducing total health care costs. MIND at Home participants receive an in-home needs~     assessment followed by up to 18 months of care coordination aimed at filling unmet needs.~   "
50530|NCT02395718|"~     To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated~     in a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A~     QDU is a medical Short Stay Unit (SSU).~   "
50531|NCT02395705|"~     The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal~     squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for~     esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy~     with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total~     2-field lymph node dissection improves the overall survival of thoracic esophageal cancer~     patients.~   "
50532|NCT02395692|"~     This phase II trial studies how well methoxyamine works when added to standard temozolomide~     in treating patients with glioblastoma that has come back. Drugs used in chemotherapy, such~     as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
50533|NCT02395679|"~     Malignant mesothelioma is an aggressive pleural disease, related to asbestos exposure. At~     present, cytotoxic chemotherapy is the only evidence based treatment for the disease, but~     efficacy is limited. The investigators have shown both in a murine model, as for the first~     time in patients, that dendritic cell-based immunotherapy induces tumor specific T-cell~     responses. However the quality and quantity of the autologous tumor cell lysate to load the~     dendritic cells was a major impediment for these trials. The investigators have now~     developed a clinical grade allogeneic tumor cell lysate which can be used to load dendritic~     cells of patients.~   "
50534|NCT02395666|"~     The purpose of this research study is to evaluate a new investigational drug to prevent~     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The~     objectives of this study will be to monitor for safety and look at efficacy of DFMO.~      The safety of the proposed dosing regimen in this trial will be tested by an on-going~     risk/benefit assessment during the study. A patient benefiting from treatment, not~     progressing on therapy, and in the absence of any safety issues associated with DFMO may~     continue on treatment up to 27 cycles with the expectation that there will be an overall~     clinical benefit.~      The procedures involved in this study include Medical history, Physical exam, Vital signs~     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the~     tumor(s), meta-iodobenzylguanidine (MIBG) scans, and Bone marrow aspirations. All of these~     tests and procedures are considered standard of care for this population. Drug~     administration is also part of this protocol, including an investigational new drug called~     DFMO.~      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day~     while on study. There will be 27 cycles. Each cycle will be 28 days in length.~   "
50535|NCT02395653|"~     The objective of this study is to evaluate the safety and clinical utility of the active,~     SSEC fentanyl 40 mcg for the management of acute, postoperative pain in pediatric patients.~   "
50536|NCT02395640|"~     This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen~     in the first-line treatment of advanced gastric cancer patients.~   "
50537|NCT02395627|"~     The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+~     patients with therapy resistant breast cancer to test the optimal sequence and dosing of~     epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C)~     will include ER-negative patients who will follow the concurrent priming, but exclude~     tamoxifen. The two arms all include vorinostat, TAM and pembrolizumab to evaluate~        -  Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and,~        -  Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin~          pembrolizumab on day 1 in Cycle 2 (Arm A)~   "
50538|NCT02395614|"~     The investigators intend to perform a prospective randomized study and compare the incidence~     of surgical wound infection between mastectomy wounds irrigated with triple antibiotic~     solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast~     reconstruction. Each patient will receive triple antibiotic solution on one breast and the~     CHG on the other breast.~   "
50544|NCT02395536|"~     The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™~     insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure~     performed in the in-office setting is as safe as LINQ™ insertions performed in the~     traditional hospital setting (operating room, cardiac catheterization or electrophysiology~     (EP) laboratory).~   "
50545|NCT02395523|"~     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy~     (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.~   "
50546|NCT02395510|"~     The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult~     population with a diagnosis of PD. PD is generally treated with benzodiazepines which are~     very effective but have a high risk for addiction, fall, and cognitive impairment. There is~     still a need for better treatment for PD for longer term use. There are other drugs within~     the SSRI/SNRI class which have proven to be effective in treating patients with this~     diagnosis.~   "
50547|NCT02395497|"~     Injuries to the external genitalia are of great concern to the military with emphasis being~     placed on the surgical reconstruction and psychological health of these Wounded Warriors.~     However, despite significant surgical advances in microvascular surgery and autologous free~     tissue transfer, conventional reconstructions cannot truly replace the complicated~     structures and functions of the penis including the urethra, erogenous sensation, and~     erectile corporal bodies. Conventional reconstruction poses several challenges: patients may~     not have sufficient donor tissue (i.e., the forearm or thigh) due to other injuries or~     previous surgery; multiple operations are often needed to restore the neophallus; the final~     reconstruction only approximates the penis' native form; recreating the urethra is~     challenging and the new urethra is prone to stricture and fistula formation; the erectile~     function necessary for sexual intercourse is often lacking; and insufficient protective~     sensation can lead to penile implant extrusion, infection, and subsequent explantation or~     loss of the reconstruction.~      For these reasons, the investigators propose the current clinical trial to determine~     functional outcomes and quality of life (QOL) for Wounded Warriors and civilians who choose~     to undergo penile allotransplantation. The investigators will combine extensive experience~     performing total penile reconstruction in a large population affected by congenital,~     traumatic, and therapeutically extirpated GU deformities and expertise in reconstructive~     transplantation using an immunomodulatory protocol to implement this study. The~     investigators anticipate that penile transplantation can potentially replace like with~     like, restoring the appearance, anatomy, and function of the recipient in a manner far~     superior to autologous reconstruction. This project will establish the ability to perform~     penile allotransplantation using an immunomodulatory protocol and will compare outcomes with~     conventional phalloplasty patient results.~      Study Design: This is a non-randomized subject self-controlled clinical trial to implement a~     cell-based immunomodulatory protocol for penile allotransplantation. An intermediate~     deliverable is achieving allograft survival and functional return with reduced~     dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus)~     immunosuppression. The long-term deliverable and goal is to demonstrate equivalent or~     superior outcomes when compared to satisfaction and QOL in conventional phalloplasty~     patients 12-60 months post-transplant.~   "
50548|NCT02395484|"~     Constipation is a heterogeneous and multifactorial disease, influenced by a number of~     different genetic and environmental factors. By applying the standard two-stage GWAS~     strategy to design and carry out a metagenome-wide association study (MGWAS) to find the~     relationship between gut microbiota and constipation, to identify disease-associated~     metagenomic markers.~   "
50549|NCT02395471|"~     This study will assess the Minimally Invasive Esophageal Cytology Collection System in~     Patients with Barrett's Esophagus or GERD Symptoms.~   "
50550|NCT02395458|"~     Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic~     strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with~     metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14~     days.~   "
50551|NCT02395445|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due~     to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) has been designed specifically for the airway management. However, despite~     its use in clinical practice, there are no comparative studies regarding direct laryngoscopy~   "
50552|NCT02395432|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due~     to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) has been designed specifically for the airway management. However, despite~     its use in clinical practice, there are no comparative studies regarding direct~     laryngoscopy.~   "
50553|NCT02395419|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due~     to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed~     specifically for the airway management. However, despite their use in clinical practice,~     there are no comparative studies.~   "
50554|NCT02395406|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due~     to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed~     specifically for the airway management. However, despite their use in clinical practice,~     there are no comparative studies.~   "
50555|NCT02395393|"~     Bronchoscopy-guided tissue sampling is a central technique in many diseases including~     diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or~     chronic rejections following lung transplantation. Confocal fluorescence microscopy is a~     novel technique used for real-time microscopic imaging of proximal and distal airways,~     microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy~     images of airways and alveolar structures during standard bronchoscopy could help recognize~     and classify the presence or absence of acute or chronic rejection in lung transplant~     recipients.~   "
50556|NCT02395380|"~     Colic and rectal resection represents a majority of hospitalizations in visceral surgery.~     The objective of this study was to evaluate the prognostic of inflammatory markers dosage~     (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal~     surgery and on the length of stay.~   "
50559|NCT02395341|"~     Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this~     study to assess changes in existing and novel surrogate measures of fertility potential~     before, during and after chemotherapy. Measures of fertility potential to be tested include~     ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and~     assessment of oxidative stress.~   "
50560|NCT02395328|"~     This study consists of a one-year randomized controlled trial investigating the impact of~     mobilized care workers trained and supported by Futures Families, a South African non-profit~     organization, that provide biweekly home visits to families with orphans and vulnerable~     children (OVC) in Tshwane (aka Pretoria) townships, South Africa. Future Families takes a~     family-based approach to addressing the needs of OVC by providing caregivers with~     information, psychosocial support, and access to external services. Caregivers will~     participate in a survey providing information on their personal wellbeing as well as key~     indicators reflecting the wellbeing of each child under their care. Newly enrolled~     caregivers will be randomly assigned to either program participation beginning in late 2014~     or to delayed participation following the impact survey about one year later. The data will~     be used to test for changes in a set of key program indicators pertaining to child~     protection, HIV prevention, psychosocial wellbeing, education and early childhood~     development. This study aims to strengthen the evidence base for effective family centered~     programming to address the needs of HIV-affected children and their caregivers.~   "
50561|NCT02395315|"~     Type 2 Diabetes Mellitus (DM) is a very prevalent metabolic disorder in the adult population~     affecting roughly 17.7 million people in the US alone. The harmful effect of DM on implant~     integration and survival has been attributed to vascular complications in the alveolar bone~     that lead to compromised blood supply and decreased bone density. Nonetheless, the specific~     detrimental effects of DM in the alveolar bone have not been investigated in humans.~      People with DM generally lose more teeth than persons without diabetes, but implant~     placement in not well controlled diabetics is not routinely performed due to the lack of~     relevant evidence and the risk for implant failure and associated complications. Chemically~     modified, micro-rough, hydrophilic (SLActive®) titanium implant surfaces have been shown to~     accelerate osseointegration of dental implants placed in diabetic animals. It has been~     hypothesized that this enhanced biologic response is due to the biocompatibility and~     hydrophilicity of the surface that actively attracts blood and is populated by progenitor~     cells, and growth factors that improve stromal cell differentiation.~      Hypotheses:~      It is hypothesized that hyperglycemia results in compromised vascularity in the mandible.~     Thus, hydrophilic TiZr implant surfaces (Roxolid®) that actively attract fluids and possess~     excellent osteoconductive properties, may enhance peri-implant bone response in diabetic~     patients to levels comparable to well-controlled diabetics.~   "
50562|NCT02395302|"~     The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after~     4 weeks of treatment using a dual action pneumatic compression device.~   "
50563|NCT02395289|"~     The purpose of the study is to examine the effects of cognitive-based compassion training~     (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being~     and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).~   "
50564|NCT02395276|"~     Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most~     common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live~     births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII)~     as result of hemodynamic instability in the perioperative period. Similar insults in adults~     with cardiac arrest or infants with neonatal asphyxia, was successfully treated with~     hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely~     an effective treatment for HII in children with cardiac anomaly, it also carries a risk for~     bleeding or infection of the surgical wound. In this randomized control trial, hypothermia~     treatment will be compared to normothermia treatment of patients in the pediatric cardiac~     intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect~     will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG,~     neurological evaluation coagulation and infection evaluation in the acute phase and by~     developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with~     minimal risks may open the door for the implementation of hypothermia as a standard care in~     PCICUs.~   "
50565|NCT02395263|"~     The purpose of this study is to determine whether Yuxintine Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in~     the Chinese Patients with Depression.~   "
50566|NCT02395250|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric~     antigen receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for~     patients with relapsed or refractory hepatocellular carcinoma (HCC).~   "
50567|NCT02395237|"~     The purpose of this study is to assess, after single oral administration under fed~     conditions, the bioequivalence between the two batches of the same glimepiride/metformin~     hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release~     combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.~   "
50568|NCT02395224|"~     The main objective is to provide original research results that may change clinical practice~     related to metastatic colorectal cancer. The study will evaluate treatment and patient care~     at different stages of the disease trajectory and the use of health care for this large~     group of patients. It will be possible to compare the effectiveness of chemotherapy,~     radiotherapy and symptomatic treatment given to real life patients with the efficacy~     reported in randomised clinical trials. By using longitudinal information on imaging,~     biomarkers, clinical staging and place of care it will be possible to improve patient~     classification at various stages of the disease. Based on this, a more appropriate,~     individualized treatment for colorectal cancer may be recommended during the phases of the~     disease trajectory. Participation in this project will not influence the treatment for~     colorectal cancer. All patients will be treated and followed-up according to current~     regional and national guidelines.~   "
50569|NCT02395211|"~     The aim of this study is to evaluate feasibility of a proprioceptive stimulation under~     visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy~     treatment in sub-acute stroke patient with Complex regional pain syndrome.~   "
50570|NCT02395198|"~     The aim of the present study is to estimate the national annual prevalence and incidence of~     current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid~     substitution treatment (OST) based on a representative sample of approximately 2,500~     outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to~     describe factors influencing HCV therapy initiation and seroconversion during OST.~   "
50571|NCT02395185|"~     While it has been shown that sucrose or milk ingestion decreases pain responses in heel~     sticks, no study up to this point has determined the best intervention for decreasing the~     pain response during casting for clubfoot deformity.~      The goal of this study is to investigate the effect of three different non-pharmacologic~     interventions (sucrose, milk, water) on pain response during clubfoot casting.~      This study will allow us to discern the best non-pharmacologic intervention for pain control~     during clubfoot casting and to provide a more pleasant, comfortable experience for patients~     and families.~   "
50572|NCT02395172|"~     To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in~     subjects with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC)~     after failure of a platinum-based doublet.~   "
50573|NCT02395159|"~     Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster~     in vascular surgery patients.~   "
50574|NCT02395146|"~     Thyroid surgeons place an enormous amount of importance and rightly so to the preservation~     of the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the~     anatomy of the nerve and meticulous dissection technique and intraoperative identification~     of the nerve are crucial to the anatomic and functional integrity of the nerve. The use of~     intraoperative neural monitoring to aid the surgeon in the identification of the RLN has~     gained acceptance and is considered standard practice in several units. However, lesser~     emphasis has been placed historically on the identification and preservation of the external~     branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies~     the cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the~     recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative~     damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is~     not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or~     complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper~     voice or an inability to produce high pitched sounds.~      Patients may also complain of weakness, tightness of the voice, and require extra effort to~     speak. Of note, voice changes with EBSLN injury are subtle in the general population but can~     be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury~     is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve~     injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend~     routine intraoperative neural monitoring of EBSLN. The Investigators have a functional~     system in use currently for monitoring recurrent laryngeal nerve intraoperatively and~     propose to study the impact of monitoring the EBSLN using the same neural monitoring device~     to improve voice results following thyroid surgery.~   "
50575|NCT02395133|"~     The primary objective of the study is to assess the ability of different dupilumab dose~     regimens, administered as monotherapy, to maintain the treatment response achieved after 16~     weeks of initial treatment with dupilumab monotherapy compared to placebo.~   "
50576|NCT02395120|"~     The study is a multi-site, double blind, parallel arm, community-based randomized controlled~     trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase~     receipt of dental care among inner-city urban and rural elementary school children who were~     screened at school and have restorative treatment needs. The study has 5 arms: The~     experimental intervention is the use of a theoretically driven CSM referral letter alone,~     the letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a~     reduced CSM referral letter plus a reduced Dental Information Guide. The control strategy is~     the use of a standard referral letter. All participating K-4 grade children will receive a~     screening at the beginning of the school year and at the study end point 7 months later to~     determine if the child received dental care.~      The primary aim is to evaluate the effectiveness of experimental (new) versus standard~     referral approach given to parents/caregivers in increasing receipt of dental care among~     their children in grades K-4. The secondary aim is to assess changes in parent/caregiver~     illness representation/perception and behavioral intention between enrollment (beginning of~     school year) and follow-up (end of school year) to understand the underlying mechanisms of~     the new vs. standard referral approach that result in receipt of dental care.~      The hypothesis is that CSM-based interventions will increase receipt of dental care compared~     to the standard referral letter.~   "
50577|NCT02395107|"~     Aortic stenosis results in increased filling pressures of the heart. Size and function of~     the left atrium may be a marker for more advanced heart disease (heart failure) in patients~     with severe aortic stenosis, not presenting any apparent symptoms.~      The goal of this study is to establish the importance and possible implications of left~     atrial dilation in asymptomatic patients with aortic valve stenosis.~   "
50578|NCT02395094|"~     Children can experience high levels of anxiety immediately prior to surgery. In fact, this~     can be the most stressful part of the whole surgical experience for children. Anxiety before~     surgery is associated with problems after surgery; such as short-term increased need for~     pain medication and long-term sleep disturbances or behaviour change. Child Life, a program~     run in some North American children's hospitals has developed ways to reduce children's~     anxiety prior to surgery. These techniques can include role-play or story books amongst~     others.~      In this study, the investigators aim to look at the benefits of the Child Life techniques on~     anxiety levels of children and their caregivers just prior to receiving anesthesia in the~     operating room. The study will include children between the ages of 3 and 10 years old,~     needing day case surgery lasting less than 2 hours, and having never had surgery before.~     They will be randomly allocated to either not receive any intervention by Child Life or to~     receive Child Life intervention in the period prior to their surgery, when they are waiting~     in the Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be~     measured as they arrive in the hospital and immediately prior to anesthesia, to see if there~     is a lower level of anxiety in the group receiving the Child Life intervention.~   "
50579|NCT02395081|"~     A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU,~     or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The~     Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16~     weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also~     be determined. The investigators will generate preliminary data regarding Vitamin D intake~     and hypertensive disorders, blood pressure, and arterial function measured by tonography.~     The investigators will independently test blood pressure and proteinuria to identify~     preeclampsia cases.~   "
51136|NCT02387788|"~     Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778~     administered twice daily for 84 days in subjects with macular edema due to RVO.~   "
50580|NCT02395068|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting~     tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head~     and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the~     registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small~     cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are~     ongoing all over the investigators' country. The main purpose of this study is to evaluate~     the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with~     solid tumors.~   "
50581|NCT02395055|"~     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar~     candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous~     injection in healthy volunteers.~   "
50582|NCT02395042|"~     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with~     Hunner's lesions.~   "
50583|NCT02395029|"~     Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten~     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells~     (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be~     conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for~     re-injection at 3 months and/or 6 months as determined by the clinician based on patient~     reported treatment satisfaction.~   "
50584|NCT02395016|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ~     trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered~     concurrently with Gemcitabine in patients with RAS wild type of locally advanced or~     metastatic pancreatic cancer~   "
50585|NCT02395003|"~     The purpose of this study is to test whether the reduced transcription of key~     lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese~     adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio~     translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte~     proliferation, which in turn will contribute to ectopic fat accumulation and insulin~     resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level~     of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat~     intake (palmitate intake), alters ceramide concentration in both plasma and adipose tissue~     (AT) and the Inflammasome complex in the different fat distribution phenotypes and their~     associations with IR.~   "
50586|NCT02394990|"~     This study is a randomised controlled trial of a new brief intervention with young (16-29)~     adult male patients who have a facial injury sustained as a result of interpersonal violence~     (fighting or assaults). It will be undertaken at the Maxillofacial outpatient trauma clinic~     at the Southern General Hospital, Glasgow. The major risk factors associated with facial~     injury in Scotland are male gender, young age, interpersonal violence and alcohol. Previous~     research with facial injury patients attending this clinic has shown that an Alcohol Brief~     Intervention (ABI) is effective in helping reduce alcohol consumption, so all patients are~     now offered ABI as standard practice. ABI is delivered by trained nurses from Addiction~     Services. This will not be withdrawn. In addition we wish to offer some patients a Violence~     Brief Intervention (VBI). This will be delivered by the same nurses who deliver the ABI. The~     study is randomised so only those selected at random will receive this extra intervention~     and all others will receive treatment as normal (ABI only). VBI is a short psychological~     intervention which uses Brief Motivational Interviewing (BMI) to encourage reflection of~     involvement in violence and consideration of strategies to avoid future violence. The~     intervention also compares participants' attitudes towards violence to those of their peers.~     The intervention takes about 15 minutes, and patients will be involved for an additional~     30-45 minutes longer than normal when they attend the clinic, including consent and baseline~     data collection. Patients will be followed up by telephone at 1, 3 and 6 months, and asked a~     suite of questions which will take approximately 15 minutes on each occasion. We wish to~     determine whether a VBI of this type has any effect on attitudes to violence or propensity~     for involvement in violence or on reinjury, examined through self report measures and~     routinely collected health and criminal justice data at 12 months post intervention.~   "
50587|NCT02394977|"~     The investigators conducted a randomized, controlled, single-blinded study of patients~     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic~     teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. The intervention and~     control groups were labeled group 1 and 2 respectively. The assessment tool was scored by~     the principle investigator and an ICU nurse. The data analyzer was blinded to group~     randomization and was not present during CPR.~   "
50588|NCT02394964|"~     The immune system is influenced by the commensal microbes that live in the gut and on the~     skin. This study aims to characterize the microbiota of subjects with autoimmune disease in~     order to determine whether certain microbial species may cause or worsen immune-mediated~     diseases~   "
50589|NCT02394951|"~     The investigators seek to investigate certain patient characteristics that would predict the~     response to a currently approved analgesic, pregabalin, in patients with chronic pain due to~     nerve damage caused by chemotherapy. Patients with this painful condition, called~     chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of~     chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The~     investigators will recruit potential subjects from both the Siteman Cancer Center and the~     Washington University Pain Management Center. Those patients who meet the inclusion and~     satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and~     thermal sensitivity testing on their extremities, will provide quality of life information~     by completing questionnaires and will receive pregabalin followed by placebo, or placebo~     followed by pregabalin [crossover design] in order to assess how well the sensory tests~     predict the analgesic effect of pregabalin (compared to placebo).~   "
50590|NCT02394938|"~     Aims. To describe a new conceptual framework and to test the effectiveness of a recorded~     music listening protocol on symptom burden and quality of life in heart failure patients.~   "
50591|NCT02394925|"~     The primary objective of this study is to determine the retention rate over a two month~     period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.~   "
50655|NCT02394080|"~     The purpose of this study is to collect safety and performance data on the use of the~     Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and~     alignment for the treatment of acute humerus fractures.~   "
78000|NCT02036437|"~     To test the safety and efficacy of titrated oral misoprostol compared to vaginal~     dinoprostone for labor induction.~   "
50592|NCT02394912|"~     The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with~     Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux~     VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical~     results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment~     into a roll in phase consisting of 2 study subjects per site prior to enrollment into the~     primary treatment phase for primary analyses. The purpose of the roll in phase is to assure~     compliance with site training on the use of the investigational device and protocol~     workflow.~   "
50593|NCT02394899|"~     There are all significant risk factors for poor early cognitive development and, as such,~     neurocognitive deficits have been demonstrated in pre-school children with sickle cell~     disease (SCD). This project assesses the efficacy of using an evidence-based early~     stimulation program, combined with components to help parents cope with stress, delivered~     during six routine monthly clinic visits to parents of children with sickle cell disease. It~     is hoped that this innovation will improve parental psychological outcomes, as well as child~     developmental outcomes.~   "
50594|NCT02394886|"~     This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot~     ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived~     mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release~     growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth~     factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may~     provide an new option in treating a diabetic foot ulcer.~   "
50595|NCT02394873|"~     This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep~     second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic~     adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors~     such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which~     can enhance wound healing and regeneration of new tissue, finally may provide a new option~     in treating a burn.~   "
50596|NCT02394860|"~     The aim of this study is to assess the influence of the severity of chronic periodontitis on~     hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to~     identify evolution of several biomarkers and correlate the clinical situation with oral~     microflora.~   "
50597|NCT02394847|"~     Electroconvulsive therapy has been used for many years for different types of physiatric~     diseases. General anesthesia is used during the procedure. Different anesthesiologists use~     different regimens. The duration of seizure is important in this procedure. The~     investigators evaluated the relationship between the dose of propofol and the number of~     electroconvulsive therapy and duration of the seizure.~   "
50598|NCT02394834|"~     The purpose of this study is to investigate biomarkers which may be predictors of efficacy~     and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy~     in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.~   "
50599|NCT02394821|"~     For odor control malignant wounds (MW), use is 0.8% metronidazole solution - second~     recommendation scientific and clinical practice. But no this formulation available in Brazil~     , and its application to nursing steeps metronidazole tablets , diluted in saline and~     applied to the bed of (MW) . Thus , it is used off label for metronidazole ( tablets orally~     applied via  topical  - but it is not intact skin or mucosa ) , nursing and eventually~     manipulate the solution at bedside , and by law this power is pharmacist bedside and can not~     be taken .~      Family antiseptic chlorhexidine was developed with the purpose of use in infected wounds~     called polihexanide ( PHMB ) . In Brazil is now available for hospital and home care ( 0.2 %~     Aquasept ® ) use. Evidence reported positive results in controlling infection of chronic~     wounds such as pressure ulcers . Although not tested its efficacy in odor control. Thus the~     study aims to compare metronidazole solution 0.8 % versus 0.2 % PHMB in odor control , where~     , if the results are favorable to PHMB we have a treatment option in odor control with ready~     to use formulation and easy access . Evaluate and compare the effectiveness of metronidazole~     solution 0.8% and polihexanide solution (PHMB) in odor control in MW. Aims: Evaluate and~     compare the time needed for odor control (reduction in days), using metronidazole and PHMB~     in MW (primary endpoint); Evaluate and compare the perceptions of patients, nurses and~     researcher on the odor MW, using metronidazole and PHMB in the MW; Evaluate and compare the~     pain reported by patients during dressing changes, using metronidazole and PHMB in the MW;~     Evaluate and compare the quality of life of patients before and after the use of~     metronidazole and PHMB in MW. This is a randomized, double -blind study with patients~     diagnosed with cancer and patients with MW with odor clinical trial . The sample consisted~     of 24 subjects divided into 2 groups (control - metronidazole group and experimental group -~     PHMB ) , recruited in one cancer hospital in the city of São Paulo (AC Camargo Cancer~     Center), which has as protocol description in odor control MW metronidazole . After~     acceptance by the subject and return the Statement of Informed Consent signed ,~     randomization will be done .~      For blinding , 0.8 % metronidazole solution will be provided by a compounding pharmacy~     (after stability testing of tablet diluted - and then stipulated expiration date) , and PHMB~     be bought from the supplier , delivered to the same compounding pharmacy which stores the~     PHMB in identical bottles to metronidazole ( only the responsible researcher will know to~     which group the subject was randomized ) .~      The evaluation of the odor will be taken by 3  employees  and the patient through 3 scales~     at zero , four, eight and twelve days ( or earlier if classified as  odorless  by 3~     reviewers and the patient ) . Two scales about painful sensations in exchange for healing ,~     one on quality of life will be applied to the patient and a specifically on the impact of~     odor on the subject's life.~      To meet the proposed objectives, the data will be analyzed by: Friedman test to assess the~     odor reduction with respect to time; Mann-Whitney (or t test) for comparison of groups and~     the Fisher exact test to compare proportions. Data will be presented in the form of~     frequency tables for categorical variables and means, standard deviations and position~     measurements for quantitative variables. Will also be performed non-parametric analysis of~     ordinal data, or parametric analysis with Generalized Estimation Equation for binomial~     variables, depending on the data distribution and the sample size.~   "
50600|NCT02394795|"~     The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination~     therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of~     chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable,~     advanced/recurrent colorectal cancer.~   "
50601|NCT02394782|"~     This is a 24-month, observational, prospective, multinational, multicenter study to~     determine the relationship between the relapse (percentage of relapse free subjects) and~     adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the~     RebiSmart®2.0 and MSdialog™.~   "
50602|NCT02394769|"~     This research study is investigating the use of aspirin as a potential chemopreventive agent~     to reduce risk of colorectal cancer~   "
50603|NCT02394756|"~     The objective of this study is to assess how various silicone hydrogel lenses perform when~     worn by subjects who are heavy digital device users.~   "
50604|NCT02394743|"~     Vascular inflammation is a key factor in both the pathogenesis and outcome of~     atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and~     cardiovascular mortality.~      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for~     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,~     the purpose of the study is to demonstrate the correlation between eGFR and vascular~     inflammation detected by 18F FDG-PET.~   "
50605|NCT02394730|"~     ADVICE is a randomised, international, double-blind, placebo-controlled trial. The purpose~     of the ADVICE study is to compare the safety and efficacy of vorapaxar in reducing d-dimer~     expression and markers of cellular immune activation over a period of 12 weeks among people~     with HIV infection who are successfully treated with combination antiretroviral therapy~     containing an HIV integrase inhibitor. A secondary objective of the study will be to~     demonstrate that following cessation of vorapaxar in patients with well controlled HIV~     replication there will be an increase in the levels of d-dimer over a 6 week period. 60~     participants from 4 clinical sites in Australia and the USA will be recruited and followed~     for a minimum of 18 weeks.~   "
50606|NCT02394717|"~     The investigators long term-goal is to help YMCA programs across the nation successfully~     acheive the Y of USA Healthy Eating and Physical Activity Standards. Our objective here is~     threefold. First, the investigators will work with South Carolina YMCA leadership to achieve~     the Healthy Eating and Physical Activity Standards and implement our HEPA Strategies in~     YMCA programs across the state, evaluate the uptake of and adherence to the standards and~     strategies, and identify factors that influence their implementation. Second, the~     investigators will evaluate the impact of acheiving the standards on children's MVPA and the~     serving and consumption of FV and water during the programs. Third, the investigators will~     evaluate the costs associated with and the cost-effectiveness of meeting the standards in~     terms of improvements in activity and healthy eating.~   "
50607|NCT02394704|"~     Intrusive negative thinking styles such as rumination are typical of many psychiatric~     disorders, are difficult to treat, and predict poor treatment outcome. The investigators~     propose to evaluate a new intervention for negative thinking that capitalizes and builds on~     the preserved ability to attend to physical sensation. The investigators will examine~     changes in physiological mechanisms and symptoms.~   "
51537|NCT02382640|"~     The purpose of this study is to assess the effect of antacid administration, and its timing,~     on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.~   "
50608|NCT02394691|"~     In this study, researchers will show to caregivers of patients how to use a tDCS device~     (this device was designed to be easy to use, with fixed parameters and only one button to~     press to run the stimulation). They will be asked to apply a stimulation every day, 5 days~     per week during for 4 weeks, in chronic patients in minimally conscious state (MCS).~      2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a~     randomized order. Before and after each session, behavioral improvement will be assessed~     with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after~     the end of the sessions to assess the long term effect of tDCS.~   "
50609|NCT02394678|"~     Intraventricular haemorrhage (IVH) - bleeding into the normal fluid spaces (ventricles)~     within the brain - is associated with a high risk of death or significant long-term~     disability. IVH leads to an increase pressure within the head and triggers inflammation and~     swelling in the surrounding brain. The ideal treatment for IVH would both rapidly relieve~     pressure and safely remove as much blood as possible to prevent any further injury to the~     brain. Currently, patients are managed by inserting a tube into the ventricle that drains~     fluid to the outside and helps reduce pressure, but does not address the blood clot itself,~     which naturally dissolves only over several days or weeks.~      Furthermore, these drains frequently block because of blood clots that for within them. If~     that occurs a repeat operation is required to replace them. Experimental treatments include~     infusing drugs to accelerate clot breakdown but this can nonetheless still take a number of~     days and the process introduces a risk of infection and fresh bleeding. Surgery to remove~     the blood clot is hazardous, technically challenging, and generally not very successful.~     Therefore, at the present time, none of the available options achieve all the stated goals~     of IVH treatment and there is an unmet need for better interventions.~      In this study the investigators propose to pilot a novel instrument that employs a high~     pressure but very localised microjet of water to mechanically disrupt blood clots and then~     sucks the debris away. This technique has been highly successful in reopening blocked~     arteries in the heart and, importantly, does so without damaging the underlying vessel~     lining. In the context of IVH, this should allow rapid removal of blood from the ventricles~     while causing minimal trauma to the brain. Clearing the blood early will prevent the~     build-up of pressure and inflammation, and improve the chances of patients making a good~     recovery.~   "
50610|NCT02394665|"~     In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although~     clinical gains have been achieved in the past, these have been modest, with a majority of~     patients succumbing to local disease progression within 2 years. New strategies for~     treatment need to be identified which enhance local control above the current treatment~     regimen in order to achieve further clinical gains in this disease. Favorable early~     experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic~     imaging can identify active tumor beyond standard MRI as well as high risk regions at risk~     for local failure. There is also clinical evidence that limited field dose escalation with~     either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible~     and safe. Coupling these findings provide the rationale for this proposed Phase II trial~     designed to define efficacy and toxicity of the novel treatment approach of whole brain~     volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM~     patients.~   "
50611|NCT02394652|"~     Cervical cancer remains an important health problem worldwide. Poor tumor oxygenation~     (hypoxia) is associated with inferior survival in cervical cancer and resistance to~     radiation treatment. Hypoxia-modifying therapies improve survival, but existing therapies~     are impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to~     decrease tumor hypoxia in animal studies and its use is associated with better survival in~     diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor~     hypoxia and thereby improve tumor response to radiation and survival in patients with~     locally advanced cervix cancer.~      This is a randomized, multicenter phase II study of standard chemoradiation in combination~     with metformin versus standard chemoradiation alone in women with locally advanced cervix~     cancer. Women randomized to the metformin group will take metformin starting 1 week prior to~     standard chemoradiation and throughout the duration of external radiation treatment. Tumor~     hypoxia will be measured by a special X-ray test called positron emission test (PET)~     performed with a hypoxia dye called FAZA. The main purpose of this study is to see if~     metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side~     effects will also be collected.~   "
50612|NCT02394639|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate~     clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so~     that hospital admission in the EMU can be avoided for some patients and an increasing number~     of patients can be examined.~      In this stage of the project video-EEG recording with the prototype will be compared to the~     conventional way (cup-electrodes and collodion) of recording in the EMU.~      Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional~     recording is completed, the patient will undergo a recording of maximum 5 hours with the~     prototype.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience and experience of the EEG-technologists will~     also be collected.~   "
50613|NCT02394626|"~     Patients with glioblastoma face a grim prognosis. Despite recent advancement in~     neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or~     recur after a median of 4-8 months. The strategy to repeat tumor resection at recurrence in~     order to minimize tumor load and thus to facilitate subsequent second-line therapy has been~     shown to be feasible and safe.~      However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and~     relies entirely on retrospective analyses. While most retrospective analyses report an~     apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival~     difference in patients with or without surgery at recurrence. With regard to the risks and~     costs inherent to surgery for glioblastoma, a randomized controlled trial is required.~      The purpose of the study is to compare the effect of craniotomy and tumor resection followed~     by adjuvant second-line therapy to no surgery followed by second-line therapy on overall~     survival, neurological status, and quality of life. Analysis of overall survival will be~     used to improve sample size estimation of a subsequent phase III trial for craniotomy and~     tumor resection of glioblastoma recurrence in cooperation with the EORTC.~   "
50656|NCT02394067|"~     This prospective study will use magnetic resonance imaging of patients with Idiopathic~     Intracranial Hypertension (IIH), to determine if the common radiological finding of~     transverse venous sinus stenosis can be reversed with standard of care medical treatment of~     IIH.~   "
50614|NCT02394613|"~     Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell~     (RGC) death. This is currently identified only after significant vision loss has already~     occurred with an early event in, and a potential marker of, this process being RGC~     apoptosis (a form of cell death).~      This study aims to investigate the tolerability and safety of ANX776, as part of the new~     Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the~     laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary~     aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis~     of glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive~     patients. As a positive control for this secondary aim of this study, patients with~     Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.~      During the study, each patient will undergo several ophthalmological examinations, imaging~     of the back of the eye using established clinical devices, and blood sampling for studying~     the safety and toxicology profile of ANX776.~      The understanding of the safety profile of ANX776 is crucial for the use of DARC in~     patients, and its application as a potentially powerful new clinical tool with which to~     identify patients with early glaucoma before their vision is lost. If successful, it opens~     the door to directly observing effects of glaucoma treatments, including the assessment of~     new, breakthrough therapies.~   "
50615|NCT02394600|"~     This pilot study is a Phase IV, single center, placebo-controlled, parallel study design~     conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine~     whether there are any benefits from Grastek® for the treatment of birch-pollen induced~     allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual~     immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis.~     The EEU provides a closed environment in which participants are exposed to a predetermined,~     controlled, constant level of airborne pollen. 96 participants will complete this study and~     will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a~     screening visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek®~     or placebo, two treatment visits and a follow-up pollen exposure visit.~   "
50616|NCT02394587|"~     Significance: The purpose of this exploratory study is to test the feasibility,~     accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on~     reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain.~     One of the most difficult symptoms for SCD patients to manage is chronic pain. Approximately~     one-third of SCD patients experience chronic pain, which is associated with pain~     catastrophizing. Pain catastrophizing is a negative mental state toward pain stimuli and~     pain experience, and is associated with increased pain severity, pain interference, and~     lower social functioning, physical functioning, and mental health. There have been no~     psychobehavioral intervention studies that have attempted to alter the experience of pain~     catastrophizing in persons with SCD. MBSR is a complementary group-based therapy that~     emphasizes nonjudgmental awareness of thoughts, feelings, and bodily sensations. With no~     pharmacological or non-pharmacological treatment for catastrophizing in persons with SCD,~     MBSR offers a potential solution to this highly significant problem for both SCD patients~     and providers. This project will be the first randomized controlled trial (RCT) of MBSR to~     reduce pain catastrophizing, and improve quality of life for SCD patients with chronic pain.~      Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke~     Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control~     group. The MBSR group will complete a 6- week, group-based telephonic MBSR program that is~     administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility,~     acceptability, and effects on pain catastrophizing will be assessed by questionnaires at~     baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR~     participants will complete semi-scripted telephone interviews to help assess intervention~     acceptability, and the wait-listed control condition will be offered the same MBSR~     intervention.~   "
50617|NCT02394574|"~     Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an~     estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life~     years (DALY) every year in developing countries.52-54 Of all environmental risks, such as~     unsafe water, poor sanitation, climate change and lead exposure, HAP accounts for the most~     mortality and DALY.55 Despite the magnitude of the problems associated with HAP, research on~     its health effects has been hindered by lack of accurate data on exposure and health~     outcomes. There are few studies available that report HAP exposures and development of~     adverse pregnancy outcomes from households using biomass fuels.~   "
50618|NCT02394561|"~     A study to evaluate the differences in the efficacy and safety of secukinumab between~     Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis~   "
50619|NCT02394548|"~     This research study is examining the benefit of a novel radiation planning approach on the~     likelihood of developing severe esophagitis (irritation and inflammation of the esophagus)~     during the course of radiation therapy with concurrent chemotherapy which is associated with~     very painful and difficult swallowing.~   "
50620|NCT02394535|"~     The goal of this clinical research study is to find the highest tolerable dose of Abraxane™~     (nab-paclitaxel) that can be given in combination with capecitabine and radiation therapy to~     patients with pancreatic cancer. The safety of this drug and drug combination will also be~     studied.~   "
50621|NCT02394522|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence~     between intervention and control arms.~   "
50622|NCT02394509|"~     The purpose of this study is to determine the feasibility and efficacy of the home-based~     cognitive self-management program HOBSCOTCH delivered at four New England medical centers.~     It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be~     delivered from a distance utilizing e-health tools for parts of the program.~   "
50623|NCT02394496|"~     Based on these results it can be envisioned that the majority of endocrine-responsive~     post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy~     (front-line, switching or extending) and/or as first-line management of metastatic breast~     cancer.~   "
50634|NCT02394353|"~     Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs~     gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by~     the transient elastography in the first year. Methods: This is a randomized clinical trial~     with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of~     Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB~     (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml~     pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated~     gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube~     with a bougie number 32 (70 ml). The variables were compared one week before surgery and in~     the postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry,~     laboratory tests and the transient liver elastography.~   "
50624|NCT02394483|"~     Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty~     subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8~     subjects. Each subject will be on study for approximately 6 weeks. Each subject will~     participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from~     Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in~     a leading edge design in which two subjects will receive study drug (1 active and 1 placebo)~     on the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on~     the second dosing day.~      All subjects will return for a post-study visit 8 to 10 days after the dose of study~     medication.~      Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after~     the first two subjects have been dosed and before dosing of the subsequent six subjects.~     There will be a complete review of safety and pharmacokinetic data of each cohort prior to~     each dose escalation.~   "
50625|NCT02394470|"~     The purpose of this study is to validate non-invasive and user-friendly methods to monitor~     systemic and pulmonary congestion in heart failure patients.~      The primary objective is to validate the role of bioimpedentiometry, pulmonary and~     subcutaneous ultrasound, to assess changes in total body water in patients with heart~     failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are~      - to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound~     to monitor systemic, pulmonary and peripheral district congestion in relation with clinical~     and laboratory variables; 2)to analyze the organizational issues related to the use of these~     methods.~   "
50626|NCT02394457|"~     PDPH is a common problem after either intentional or unintentional Dural puncture. It is~     especially common in young female patients and in patients undergoing Lumbar Puncture using~     the typical kit containing large 20 gauge needles (1).~      Hypothesis is that Cosyntropin therapy is at least as effective as current conservative~     therapy (caffeine/fluid) and/or Epidural Blood Patch.~      Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or~     (2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to~     the procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD)~     day 1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study~     may request crossover to EBP at anytime after a 24 hour assessment period is completed per~     Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on~     the patient in order to complete this study.~      Current treatments consist primarily of non-invasive treatment with intravenous fluids and~     caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg~     IV bis in die (BID) x 1d doses is approximately 70% (2). However this therapy has been~     linked to post-treatment seizures. EBP was originally thought to be 90% effective with~     repeat treatment efficacy approaching >96%. However more recent studies by Taivainen et al~     (3) have shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in~     patients with signs of increased intra-cranial pressure (ICP), coagulation issues,~     signs/symptoms of Central Nervous System (CNS) /systemic infection or local infection at the~     site of the EBP, thus resulting in decreased utility. Complications are also quite serious~     ranging from meningitis, spinal hematoma, repeat dural puncture, localized infection and~     vagal response to the procedure. EBP are not typically performed until after conservative~     measures have failed which leads to further prolongation of the patients decreased~     functional status and pain. Additionally, the cost of both treatments is substantial~     considering prolonged ED visits for conservative treatments often followed by the time and~     expense of an EBP.~      The goal of this investigation is to aid in the confirmation of case reports advocating the~     economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment~     of PDPH (4,5,6,7,8,9).~   "
50627|NCT02394444|"~     The aim of this study was to assess the impact of an early psychological intervention,~     Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental~     health, and preterm infant development in the motor, cognitive, emotional and behavioral~     domains at a corrected age of 18 months.~   "
50628|NCT02394431|"~     Sickle Cell Disease is a serious disease that is life-threatening for patients being~     homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann~     hospital currently regularly treats about 70 homozygous adult patients and this number is in~     constant augmentation.~      Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the~     haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.~      The hypervolemia in patients with sickle cell disease causes an overestimation of the~     ejected left ventricular fraction measured by echocardiography, this parameter being very~     dependent of the blood volume.It has already been shown that the left ventricular ejection~     fraction was normal in most patients with sickle cell disease, but that its evaluation by~     parameters independent from the blood volume showed the existence of a dysfunction.~      Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of~     the cardiac function, independent of the blood volume. This technique hasn't been used much~     in sickle cell disease patients. A study using 3D speckle tracking on a limited number of~     sickle cell disease patients failed to show a strain anomaly. Moreover, the study~     highlighted a higher global longitudinal strain in this patient population. The~     investigators find these data hard to explain and in contradiction with previous studies~     using other cardiac function evaluation techniques, independent from the blood volume.~      The primary goal of this study is thus~        -  to study the longitudinal strain by 2D echography~        -  to determine if anomalies of the longitudinal strain exist in sickle cell disease~          patients with a normal ejected left ventricular fraction, compared to a control group~          of healthy patients.~      The secondary goal of this study is to correlate, inside the sickle cell disease group, the~     possible strain anomalies with biological gravity parameters of the disease.~   "
50629|NCT02394418|"~     Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical~     course of delirium and neuroinflammation in mechanically ventilated patients using CAM-ICU~     scale and protein S100b in serum.~   "
50630|NCT02394405|"~     Assessment of the severity of oxidative stress caused by the on-pump and off-pump CAGB using~     mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.~   "
50631|NCT02394392|"~     1. Investigate the clinical characteristics, medication satisfaction and quality of life~          of anti-hypertensive drugs in Korean hypertensive patients~        2. Observe the changes of medication satisfaction and compliance in patients after~          switchting to Fimasartan~   "
50632|NCT02394379|"~     To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL~     following cataract surgery.~   "
50633|NCT02394366|"~     Delayed wound healing leads to increased risk for infection, and thus increased risk for~     morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound~     healing. The investigators will conduct a double-masked, placebo-controlled cross-over~     clinical pilot trial in order to evaluate the effects of a topical, homeopathic/herbal salve~     (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow.~   "
50635|NCT02394340|"~     This is an open-label, maximal use study evaluating the drug interaction potential of~     luliconazole cream 1% in subjects with tinea pedis and tinea cruris~   "
50671|NCT02393872|"~     The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based~     intervention aiming to create a more supportive social and physical environment to promote~     lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle~     income countries and from vulnerable groups in high income countries in Europe.~   "
50934|NCT02390440|"~     This study is looking at a novel therapy of numbing medication injected directly around the~     fracture site. The purpose of this study is to determine if the study medication, EXPAREL®,~     is a viable alternative to current therapies for rib fractures.~   "
50636|NCT02394327|"~     Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis,~     but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route~     can be required to alleviate inflammatory process and reach an appropriate time for elective~     surgery in patients with high operative risk or marked local inflammation or organ~     dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is~     often needed because common bile duct (CBD) stone is accompanied in patients with acute~     cholecystitis at reported rate from 7-20%.~      Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice~     versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone~     who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB~     through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or~     plastic stent has alternatively been attempted in patients who have contraindications for~     PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its~     relatively low technical success rate and specific concern about post-ERCP adverse event but~     it minimizes catheter keeping duration, and provides effective clinical improvement via~     physiologic route.~      Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are~     comparable in terms of clinical efficacy and safety.~   "
50637|NCT02394314|"~     A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the~     safety and pharmacokinetics of MEDI0382 in healthy volunteers.~   "
50638|NCT02394301|"~     ENDURE is a prospective, observational study aimed to document clinical response and side~     effects associated with compounded psoriasis medications when prescribed as routine care. As~     a secondary initiative, this study will assess methotrexate systemic absorption and toxicity~     in patients prescribed a methotrexate-containing compounded formulation.~   "
50639|NCT02394288|"~     This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release~     in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study~     will provide important evidence on how to interpret postoperative cardiac troponin~     elevations.~   "
50640|NCT02394275|"~     The primary goal of this proposal is to study the outcome of patients with recurrent~     Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation~     (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the~     safety of FMT and to determine the clinical response, treatment failure and relapse rate in~     patients treated with frozen-and-thawed FMT; to assess the functional health and well-being~     of patients in each arm using the validated tool, and to determine the feasibility of~     providing standardized FMT in multiple centres across Canada, including community hospitals.~     The metagenomics will also be conducted from the stool samples collected from select~     patients from each arm: pre and post treatment and the matching donors. The metagenomics~     data will be used to determine the bacteria which may have contributed to the cure of CDI.~   "
50641|NCT02394262|"~     Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive~     diagnostic imaging modality in patients with stable chest pain. Besides conventional~     CT-reading, CCTA is also capable to identify several morphologic and geometric~     characteristics of atherosclerotic plaques. Recently, the investigators showed that the use~     of semi-automated plaque quantification algorithm identified parameters predictive for acute~     coronary syndrome on top of clinical risk profiling and conventional CT-reading. In~     addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are~     described as related to coronary artery disease and cardiovascular events. Prospective data~     with sequential analysis of atherosclerotic plaques combined with different atherothrombosis~     biomarkers are currently lacking, but will provide important clues about the pathophysiology~     of plaque progression and atherothrombosis.~   "
50642|NCT02394249|"~     Background of the study:~      A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major~     focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical~     activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical~     activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be~     spent. Several recent epidemiologic studies suggest that excessive sitting, independent of~     moderate to vigorous physical activity, has detrimental health effects. Another possibility~     to sit less is by increasing low intensity physical activities as slowly walking and~     standing. A recent published study of Duvivier and colleagues suggests that sitting less and~     replacing it by slowly walking and standing has a better effect on insulin action and~     cardiovascular risk factors than the combination of one hour MVPA per day and sitting the~     rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research~     is not performed in subjects with overweight/obesity.~      Objective of the study:~      To assess the effect of low intensity physical activity on plasma insulin levels, cognition~     and mood in subjects with overweight/obesity~      Study population:~      21 subjects between 40-80 years old with overweight/obesity~      Intervention:~      2 activity regimes of 4 days: a sitting regime and a sit less regime~   "
50643|NCT02394236|"~     Thus, the purpose of the present study was to evaluate the effects of continuos exercise~     training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope~     (OUES) in patients with coronary artery disease.~   "
50644|NCT02394223|"~     Primary objective :~      The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection~     in patients undergoing TRUS prostate biopsy, as compared to standard pathological~     evaluation.~      Secondary objective:~        -  Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores~        -  Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores~        -  Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate~          biopsy cores~        -  Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores~        -  Evaluate FFOCT procedure time~   "
50645|NCT02394210|"~     Post-authorisation prospective follow-up study to assess the clinical impact on time to~     progression (TTP) from the start of anti- multiple myeloma treatment at the onset of~     asymptomatic relapse/biological progression versus start of treatment at the time of~     symptomatic relapse.~   "
50654|NCT02394093|"~     To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing~     dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin~     tablets and aspirin effervescent tablets in healthy adults.~   "
50646|NCT02394197|"~     In the context of malaria elimination in the Americas, solid evidence is necessary of the~     effectiveness of anti-malarial control measures delivered to the affected individuals. In~     the Americas, most P. vivax infections are sensitive to Chloroquine (CQ) and Primaquine~     (PQ), and the most effective treatment worldwide comprises administration of a total dose of~     25 milligrams (mg)/Kilogram (kg) weight of CQ distributed in three days and 3.5 mg/kg body~     weight of PQ administered during 14 days (T14). In Mexico, CQ and PQ have been administered~     since the late 50´s to treat malarious patients. In 1999 the National Malaria Control~     Program implemented an intermittent single doses treatment (ISD) as part of the overall~     strategy. After the blood sample was obtained for diagnosis of symptomatic patients, a~     single combined dose of CQ and PQ was administered, and after malaria infection~     confirmation, additional doses were administered monthly alternating each three months,~     during 3 years. Although, the number of malaria cases were reduced in most affected regions,~     in Southern México, many patients under ISD present recurrent blood infections, presumably~     relapse episodes were observed.~      Working hypothesis: the administration of ISD is low effective to eliminate relapse episodes~     and its effectiveness depends on the coincidence of the relapse episodes and the~     administration of the medication), while the T14 is highly effective to eliminate P. vivax~     primary and relapse infections.~      Objective: To determine the antimalarial drug effectiveness of the ISD and T14, based on CQ~     and PQ for the treatment of uncomplicated P. vivax infection (primary and recurrent blood~     infections) in Southern Mexico.~      Methods: The study was carried out in malaria affected communities of Southern Mexico,~     following the WHO recommendations for clinical studies. Symptomatic patients diagnosed with~     P. vivax infection that meet the inclusion criteria, were invited to participate. After they~     accepted by informed consent, patients were semi-randomized and treated with either T14~     (14-day treatment) or ISD (18 intermittent single doses of CQ-PQ). Clinical,~     parasitological, molecular and serological parameters were monitor over a 12-month follow up~     period to evaluate the treatment outcomes to cure blood infection and relapsing episodes.~     The study was conducted from February-2007 to October-2010. The results of this study will~     be used to assist the Ministry of Health of México in assessing the current national~     treatment guidelines for uncomplicated P. vivax malaria~   "
50647|NCT02394184|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     replacement (TAVR) in patients with bicuspid aortic valve stenosis.~   "
50648|NCT02394171|"~     Health Is Power (HIP) was a community based health intervention designed to increase~     physical activity among women of color. It was funded by a grant from the National Cancer~     Institute of the National Institutes of Health. The purposes of the study were (1) to~     determine whether a 6 month, group cohesion intervention is more effective for increasing~     physical activity compared to a 6 month, group cohesion comparison targeting improving~     dietary habits (2) to determine whether residence in a neighborhood supportive for physical~     activity helped women maintain their physical activity from 6 to , and (3) to determine~     whether this effect was transculturally replicable.~   "
50649|NCT02394158|"~     Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent~     gestational diabetes mellitus recurring in previously affected pregnancies.~   "
50650|NCT02394145|"~     Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet~     reactivity to clopidogrel than did those with normal renal function. We recently reported~     platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with~     onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted~     genetic influence in high platelet reactivity in patients with ESRD on HD.~   "
50651|NCT02394132|"~     The purpose of this study is to investigate the effectiveness of using either radiotherapy~     (RT) or Imiquimod (ImiQ) to treat the Lentigo Maligna (LM), when surgery is not possible, is~     refused, or fails.~      Surgery is the standard treatment for people diagnosed with LM. However for some people, it~     may not be possible due to the location of their LM lesion(s).~      Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend~     radiotherapy for the treatment of LM however there is no clinical trial evidence for this~     and a trial is needed to prove which treatment is safer and more effective. Some clinicians~     may also recommend the use of a cream called Imiquimod. It is approved and widely used in~     Australia to treat solar keratosis, superficial basal cell carcinoma, external genital~     warts, and perianal warts. Although not currently licensed for treatment use in LM, there is~     some evidence to suggest that it is both safe and effective in treating LM.~      This trial will scientifically evaluate and compare these two treatments in a controlled~     clinical setting.~   "
50652|NCT02394119|"~     Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority~     of Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease~     remission in SD-INS.~      Eligible participants will enter a 1-month run-in period, during which instruction on urine~     collection and dipstick readings will be carefully reviewed, compliance assessed, and~     therapy with RAS inhibitors withdrawn and, in hypertensive children replaced by other~     anti-hypertensive drug.~      After run-in period, children will be randomized to either the intervention arm (Ofatumumab)~     or the comparator arm (Rituximab).~      After infusion of intervention or comparator, steroids will be maintained at initial dose~     for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.~      One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and~     withdrawn within 2 additional weeks.~      All patients will be followed for up to 24 months. In case of relapses during the study (see~     outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in~     order to achieve remission. At remission, patients will be treated with another infusion of~     either Oftumumab or Rituximab, according to the initial randomization.~      After infusion of intervention or comparator, steroids will be maintained at initial dose~     for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.~      One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and~     withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses~     during the study.~   "
50653|NCT02394106|"~     Double-blind, two-parallel-arm, placebo-controlled randomized clinical trial testing the~     superiority of Ofatumumab versus placebo in the treatment of children with DR-INS.~     Participants will be stratified according to eGFR at enrollment.~      Eligible participants will enter a 3-months run-in period, during which instructions on~     urine collection and dipstick readings will be carefully reviewed, compliance assessed and~     any immunosuppressive therapies withdrawn according to the following schemes:~        -  prednisone will be tapered off by 0.3 mg/kg per week until complete withdrawal;~        -  calcineurin inhibitors and mofetile mycophenolate will be decreased by 50% and~          withdrawn after 2 additional weeks In order to minimize the risk of complications of~          uncontrolled INS a treatment with ACE-inhibitor at 6 mg/m2 will be maintained or~          started in all patients.~      After run-in period, children will be randomized to the intervention arm (Ofatumumab) or~     comparator arm (placebo). Randomization will be stratified by eGFR at randomization: ≥90 and~     <90 ml/min/1.73 m2.~      All patients will be followed up to 12 months and they will leave the study at time of~     relapse.~      Relapse will be defined as uPCR ≥2000 mg/g (≥200 mg/mmol) or ≥ 3+ protein on urine dipstick~     for 3 consecutive days.~   "
50657|NCT02394054|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, the investigators are still learning about the complex~     biological processes that contribute to positive social interactions and the ability to~     develop and maintain social relationships. Recent research has begun to focus on~     vasopressin, a neuropeptide that is naturally produced in the hypothalamus, because~     administration of this neuropeptide has been associated with empathy, cooperation, memory of~     social stimuli (e.g., faces), and brain activity in neural regions associated with social~     and emotional processes. To date, several aspects of vasopressin's effects on social~     behavior have been unexplored. As such, the overarching goal of this project is to examine~     the effects of intranasal vasopressin on several tasks involving learning and social~     processes. In addition, the investigators will explore associated neural activity through~     functional magnetic resonance imaging (fMRI). Results from the study will inform our~     understanding of the neurobiology of socioemotional processes.~      The investigators hypothesize that compared to placebo, vasopressin will improve deception~     detection, increase empathy and altruism, enhance responses to photo stimuli of primary~     caregivers, and improve learning when the subject has a prosocial goal of teaching another~     person. These effects will manifest in behavioral and neural activity. It is also~     hypothesized that main effects will not be found for vasopressin, but rather, analyses of~     relevant moderators will elucidate these findings.~   "
50658|NCT02394041|"~     The principal objective of the trial is to demonstrate that acupuncture could reduce the~     caesarean section rate for cervical dystocia.~      Secondary objectives:~      To demonstrate that acupuncture can:~        -  reduce morbidity, fetal mortality and duration of childbirth;~        -  reduce the cost of care, due to diminution of caesarean sections and duration of~          obstetric labor;~        -  to evaluate the tolerance.~   "
50659|NCT02394028|"~     This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the~     safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to~     severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF)~     naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor~     inhibitors.~   "
50660|NCT02394015|"~     Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated~     Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent~     Ovarian Cancer (ROC), According to SmPC.~   "
50661|NCT02394002|"~     The relation between burst and suppression periods in transcranial and direct cortical~     recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is~     studied.~      60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine~     surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures~     (Helios Klinikum Wuppertal).~   "
50662|NCT02393989|"~     Background: This 3-year clinical trial compared the performance and post-operative~     sensitivity of a posterior resin composite with that of bonded-amalgam in large sized~     cavities. Additionally, it was evaluated whether resin composite could be an alternative for~     bonded amalgam.~      Methods: This was a randomized clinical trial. Patients in need of at least two posterior~     restorations were recruited. Authors randomly assigned one half of the restorations to~     receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams~     and composites were evaluated for their performance on modified Ryge criteria and~     post-operative sensitivity using VAS for 36-months.~   "
50663|NCT02393976|"~     Compare the results in terms of morbidity, mortality and hospitalization among patients with~     input from immunonutrients and patients with enteral nutrition intake of high calorie and~     high protein undergoing colorectal surgery within a multimodal rehabilitation program.~   "
50664|NCT02393963|"~     This is a randomized, double blinded, controlled trial in patients undergoing elective Total~     Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive~     intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline~     placebo.~   "
50665|NCT02393950|"~     The study is a dose escalation study with 8 planned dose levels. The study is a 4-period~     crossover design where each healthy volunteer will be randomised to receive three dose~     levels of ODM-106 (single doses) and one dose of placebo. The study will look at the~     pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects~     the body) of ODM-106.~   "
50666|NCT02393937|"~     The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the~     treatment of Rosacea.~   "
50667|NCT02393924|"~     This study is to observe the different anti-cancer treatment regimens and their sequencing~     throughout the course of the disease in patients with unresectable locally advanced (LA) or~     metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment~     regimen measured as progression-free survival (PFS).~   "
50668|NCT02393911|"~     Currently, the pathogenesis of Localized Provoked Vulvodynia (LPV) has not been elucidated.~     Few observations may point to involvement of the microbiome: the association of LPV with~     preceding chronic recurrent candidiasis, and the reports of the beneficial effect of a diet~     avoiding oxalate on Vulvodynia.~      Studies in the new field of microbiome research focus on the composition of overall~     microorganisms in our body and their impacts on our health. Changes in the composition of~     the vaginal microbiota (dysbiosis) have been linked with different health and disease~     states. We have also shown recently that women can be divided into 2 groups according to the~     composition of their vaginal microbiome.~      The proposed study will compare the vaginal microbiome of women with severe LPV, not treated~     by diet and otherwise healthy, to women without LPV (we will also compare our results to the~     NIH HMP data). Vaginal pH and date of menstrual cycle will be checked. We propose that~     dysbiosis in the vaginal microbiota may trigger the development of LPV.~   "
50669|NCT02393898|"~     The purpose of this study is to evaluate the safety and efficacy in the frontline treatment~     of ovarian cancer in participants 70 years of age and older in routine clinical practice in~     Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by~     bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).~   "
50670|NCT02393885|"~     The objective of this study is to establish the safety and effectiveness of a dual~     epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial~     Fibrillation or Longstanding Persistent Atrial Fibrillation~   "
50672|NCT02393859|"~     B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according~     to risk characteristics to ensure that appropriate treatment is administered to patients~     with high-risk of relapse. In general, pediatric treatment regimens are more intense than~     those employed in adults and include courses of combination chemotherapy. Standard of care~     chemotherapy is associated with considerable toxicity. There is a lack of novel treatment~     options for subjects who relapse or are refractory to treatment. Therefore, innovative~     therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain~     antibody construct designed to link B cells and T cells resulting in T cell activation and a~     cytotoxic T cell response against CD19 expressing cells. This study will evaluate the~     event-free survival (EFS) after treatment with blinatumomab when compared to standard of~     care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of~     minimal residual disease compared to SOC chemotherapy will also be investigated.~   "
50673|NCT02393846|"~     The aim of this study is to analyse the effect of ketoprofen gel in patients presented with~     ankle sprain to the emergency department.~   "
50674|NCT02393833|"~     The serum protein research study is a substudy of the core study 'Maintenance Chemotherapy~     in Hormone Non-responsive Breast Cancer'. This substudy is an evaluation of blood proteins~     and their relationship to breast cancer treatment. It will assess the levels of Vascular~     Endothelial Growth Factor (VEGF), Soluble HER2 Protein (NRP, neu-related protein) and~     Vascular Cellular Adhesion Molecule-1 (VCAM-1) in serum samples of patients' blood at~     different time points. The goal is to evaluate differences in serum levels between patients~     receiving the maintenance chemotherapy and those who do not. The serum levels will be also~     examined to determine if they vary during the three year period of evaluation. In addition,~     the serum levels of patients who have a recurrence of their breast cancer will be compared~     with those who remain disease free. The information obtained from these studies will enable~     breast cancer physicians to better tailor therapies for future patients.~   "
50675|NCT02393820|"~     Open-label, multicenter, single arm phase II study, set up in collaboration with the REFCOR,~     evaluating the activity and safety of single agent pazopanib in recurrent or metastatic~     tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the~     activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).~   "
50676|NCT02393807|"~     The current study will investigate the relative bioavailability of a spray dried dispersion~     solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF~     06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a~     nanosuspension under fasted or fed conditions in healthy adult subjects.~   "
50677|NCT02393794|"~     Investigate the use of romidepsin as combination therapy with cisplatin in locally recurrent~     or metastatic triple negative breast cancer or BRCA1 or BRCA2 mutation associated locally~     recurrent or metastatic breast cancer.~   "
50678|NCT02393781|"~     The aim of this prospective study is to assess the prognostic value of bioactive plasma~     adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international~     multicenter study and to validate the findings concerning the association of ADM~     concentration and the use of vasopressor therapy, organ failure and outcome.~   "
50679|NCT02393768|"~     In this study, the investigators will determine whether patients with documented~     atherosclerosis are characterized by specific epigenetic changes in circulating cells of the~     innate immune system, compared to patients without atherosclerosis.~   "
50680|NCT02393755|"~     This phase I/II trial studies the side effects and best dose of nintedanib when given~     together with capecitabine and to see how well they work in treating patients with~     colorectal cancer that has not responded to previous treatment (refractory) and has spread~     to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It may also block the growth of new~     blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving nintedanib with~     capecitabine may be a better treatment for colorectal cancer.~   "
50681|NCT02393742|"~     Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes~     reductions in vascular, movement (motor) and cognitive functions. This study will~     determine if daily oral supplementation (3 months) with a compound that increases NO in the~     body, i.e., sodium nitrite, improves vascular, motor and cognitive function in older adults.~     The project also seeks to provide insight into the biological reasons (mechanisms) by which~     supplementation with sodium nitrite improves physiological function in older adults.~     Overall, this research will provide scientific evidence supporting the use of sodium nitrite~     for preserving physiological function and preventing clinical disease and disability with~     aging.~   "
50682|NCT02393729|"~     All the studies underlined the high frequency of co-morbid associations in specific learning~     disorders. Understanding the reasons for these associations could enable us to determine the~     cerebral bases that underlie each disorder. Their frequent association suggests the~     etiological bases are partly common, it seems logical to turn to explanatory models of~     various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007)~     suggests a specific disorder of procedural learning. But the brain networks involved in this~     learning could be achieved separately. We intend therefore to study the neural networks~     involved in learning procedural and compare networks recruited among children with specific~     learning disorder alone or in combination (co-morbidity). The children included in the study~     have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The~     procedure includes a neuropsychological evaluation and a brain MRI study with a~     morphological and a functional part. During fMRI the child realizes a automated motor task~     contrasting with a task involving learning procedural.~   "
50683|NCT02393716|"~     The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is~     safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac~     aneurysms.~   "
50711|NCT02393352|"~     This study evaluates the benefits of dry needling in trigger points on autonomic nervous~     system, photoelectric plethysmography, body composition in patients with fibromyalgia~     syndrome.~   "
51565|NCT02382276|"~     The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with~     alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.~   "
50684|NCT02393703|"~     The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of~     important proteins and nucleic acids that serve as messenger systems in the blood and~     tissue. Blood and tissue from patients with pancreatic cancer will be compared with blood~     and tissue from patients with noncancerous pancreatic disease. Including patients without~     cancer will allow the investigators to establish normal values, which currently do not~     exist. The investigators will then look to see whether exosome activity has a connection to~     disease recurrence and outcomes in patients. The results of this study will be the basis for~     future studies exploring this area.~   "
50685|NCT02393690|"~     This randomized phase II trial studies how well iodine I-131works with or without~     selumetinib in treating patients with thyroid cancer that has returned or has spread from~     where it started to other places in the body. Many thyroid cancers absorb iodine. Because of~     this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as~     part of standard practice. It is thought that the more thyroid tumors are able to absorb~     radioactive iodine, the more likely it is that the radioactive iodine will cause those~     tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose~     tumors still absorb radioactive iodine. It is not yet known whether iodine I-131 is more~     effective with or without selumetinib in treating thyroid cancer.~   "
50686|NCT02393677|"~     80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years~     old,scheduled for elective upper limb orthopaedic surgery under supraclavicular brachial~     plexus block, were included in this prospective study. The patients were randomly assigned~     to group R (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients~     in each group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received~     Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.~   "
50687|NCT02393664|"~     Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the~     advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable~     option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally,~     current lung cancer screening policy recruits increasing number of candidates requiring~     thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated~     general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an~     endobronchial blocker has been considered mandatory in thoracoscopic surgery. However,~     adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated~     thoracoscopic technique has developed to reduce the adverse effects of intubated general~     anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in~     thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As~     an enhanced recovery is the major goal of modern minimally invasive surgery, the~     investigators hypothesize that nonintubated thoracoscopic technique can facilitate and~     improve the recovery quality after surgery. To this end, the investigators will recruit 300~     patients in subgroups including patients undergoing segmentectomy/lobectomy, wedge resection~     and geriatric patients in this two-year project. Patients will be randomly allocated in~     nonintubated and intubated groups and quality of recovery of all patients will be evaluated~     according the protocol of Postoperative Quality of Recovery Scale. In the meantime, the~     preoperative and postoperative cytokines will be compared between the groups as well as~     patients with different recovery scales.~   "
50688|NCT02393651|"~     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have~     limited effects on motor recovery. Therefore, investigating new potential therapeutic~     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of~     non-invasive electrical stimulation where a weak current is applied through electrodes over~     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which~     can last up to one day with late LTP-like plasticity protocols in a polarity and~     site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several~     pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke~     patients, but it's still unclear how tDCS should be repeated over multiple days to optimally~     enhance recovery and training effects. Using a late LTP-like plasticity protocol could~     increase effectiveness of standard clinical care rehabilitation sessions and thus enhance~     the effects of rehabilitation. Therefore, the investigators want to investigate how late~     LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of~     this study can provide important guidelines on effective motor therapy during stroke~     rehabilitation.~      Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during~     the subacute phase after stroke.~      Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute~     stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper~     limb motor function during the subacute phase after stroke.~   "
50689|NCT02393638|"~     This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical~     simulator for training endoscopic sphincterotomy.~   "
50690|NCT02393625|"~     This is an open label multi center trial to determine the safety and efficacy of ceritinib~     in combination with nivolumab in ALK-positive NSCLC patients~   "
50691|NCT02393612|"~     Sarpogrelate hydrochloride, a selective 5-HT2A antagonist, has been widely used as an~     anti-platelet agent for the treatment of PAD. DP-R202 is a new Sarpogrelate hydrochloride~     product improved patient's convenience and disadvantage of dosage regimen of previous drug.~     The aim of this study was to compare the efficacy and safety of DP-R202 and Anplag® Tab in~     patients with PAD~   "
50692|NCT02393599|"~     The primary objective of this study is to determine if there are significant interactions~     between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine~     infusions by measuring adverse events (AEs) and cardiovascular responses including heart~     rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).~   "
50693|NCT02393586|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK)~     and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following~     single doses of faropenem plus amoxicillin/clavulanic acid.~   "
50742|NCT02392949|"~     Previous studies have shown that peripheral muscles weakness or inhibition is related to~     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle~     weakness for patients with spinal pain. The purpose of the study was to assess the effect of~     spinal mobilization on the maximal muscle strength of the shoulders.~   "
50694|NCT02393573|"~     Major surgery results in a stress- induced catabolic response, marked by post-operative~     insulin resistance, hyperglycemia and loss of body protein, which is associated with~     increased morbidity, mortality and adverse outcomes. There has been a great deal of research~     on different approaches to optimize post-operative insulin sensitivity including hormonal~     and nutritional interventions, minimally invasive surgical techniques and epidural~     anesthesia. However, the correlation between insulin resistance and body protein loss is not~     well understood. Metformin is the most widely used insulin sensitizing and blood~     glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate~     the correlation between insulin resistance and body protein loss in pre-diabetic~     lung/colorectal resection patients; 2) investigate whether the post-operative metabolic~     state can be improved by the pre-operative administration of metformin; and assess the~     impact of metformin on surgical complications and hospital length of stay. The results of~     this study will provide insight into the relationship between insulin resistance and~     post-operative adverse events and potentially suggest a novel approach to improve outcomes~     using Metformin, a drug already in wide clinical use.~   "
50695|NCT02393560|"~     The purpose of this study is to determine presence and volume of monosodium urate (MSU)~     crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout~     subjects treated with allopurinol with and without visible tophi.~   "
50696|NCT02393547|"~     This will be an open label clinical trial with all subjects receiving both lorcaserin and~     varenicline with a primary aim of reducing post cessation weight gain.~   "
50697|NCT02393534|"~     Doctors frequently speak with their patients over the telephone. Having a visit with a~     doctor over the telephone rather than face-to-face can be convenient for patients and allow~     them to save time and money on transportation and missed time from work. However, some~     patients may prefer seeing the doctor in person. In this study, we will study two groups of~     patients - some who have their visits with their doctor over the telephone and some who have~     them face-to-face. Using surveys and interviews, we will study if the groups differ in their~     satisfaction with their visit with their doctor after participating in the study for 6~     months. We will also look at doctor satisfaction with telephone visits, use of clinic~     resources and if patients received recommended care such as laboratory tests and vaccines~     during the study period.~   "
50698|NCT02393521|"~     The aim of this study was to investigate the efficacy of a self-administered vibration~     therapy treatment on neck pain, disability and pressure pain thresholds in patients with~     non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized~     that patients receiving vibration therapy would report less perceived neck pain, disability~     and present higher PPTs after receiving vibration therapy when compared to a control~     no-treatment group.~   "
50699|NCT02393508|"~     In this study, the investigators will be evaluating the impact of red blood cell age in~     patients receiving chronic blood transfusions in the outpatient setting. This study will~     have a double-bind, randomized trial design, meaning that the investigators and participants~     will not be told the group assignment at study enrollment.~      Study participants will be randomly divided into two groups (50% of participants in each~     group) by a computer generated block randomization schema. The 'fresh blood' group will~     receive blood units that are 7 or less from the time of donor collection, and the 'aged~     blood' group will receive blood units that are greater than 21 to 42 days from the time of~     donor collection. The number of units of blood transfused will be decided based on the~     participant's hemoglobin level before blood transfusion.~      The primary goal of our study is to compare annual red blood cell product use (the number of~     units given per patient in a year). The investigators will also be comparing groups to~     evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in~     the blood), overall transfusion and care cost difference, and participant time spent in~     outpatient departments.~      Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a~     decrease the in red cell transfusion rate, with subsequent clinical benefits including~     reduction of transfusion reaction frequency and systemic iron burden.~      This study will be taking place within the Calgary Zone of Alberta Health Services only.~   "
50700|NCT02393495|"~     Different studies have been made in an attempt to reduce the pain and the duration of the~     process of outpatient insertion of the intrauterine device. in this trial, the investigators~     aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain,~     decrease the process of insertion, in addition, it reduces the incidence of malposition of~     IUD as well as the risk of complications.~   "
50701|NCT02393482|"~     The purpose of the study is to evaluate the impact on quality of life, psychological health,~     sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with~     endometriosis, through the administration of self reported questionnaires. Amenorrhea in the~     first group is caused by balanced assumption of estroprogestins, in the second group is~     caused by GnRHa-induced hypoestrogenism.~   "
50702|NCT02393469|"~     The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of~     morbidity and mortality, suggesting that the lung as a single therapeutic target, has not~     contributed in the past 20 years, significant changes to the natural evolution of the~     disease. Direct treatment for systemic changes and comorbidities, in fact, the most~     responsible for high rates of treatment failure could mean a new hope of life for~     individuals with COPD. This research project characterized as interdisciplinary and~     multidisciplinary program will be headquartered in Pulmonary Rehabilitation of the Santa~     Cruz Hospital which has partnerships with local companies . Its main objective will be to~     analyze cardiorespiratory and functional capacity in COPD patients not rehabilitated and~     rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary~     Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be~     included in this survey of COPD patients who were referred to a rehabilitation program with~     a clinical diagnosis of disease. In research activities to assess cardiorespiratory and~     functional capacity of COPD, pre and post-program (02 and 12 months) are provided for~     Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise~     protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where~     their vital signs are measured before, during and after each session. Thus, it is believed~     that it will be possible to refine the knowledge of mechanisms by which the judicious use of~     pulmonary rehabilitation can control the progression of COPD.~   "
50703|NCT02393456|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, the investigators are still learning about the complex~     biological processes that contribute to positive social interactions and the ability to~     develop and maintain social relationships. Recent research has begun to focus on oxytocin, a~     neuropeptide that is naturally produced in the hypothalamus, because administration of this~     neuropeptide has been associated with increased trust, generosity, empathy, cooperation,~     memory of social stimuli (e.g., faces), and brain activity in neural regions associated with~     social and emotional processes. To date, several aspects of oxytocin's effects on social~     behavior have been unexplored. As such, the overarching goal of this project is to examine~     the effects of intranasal oxytocin on several tasks involving social processes. In addition,~     the investigators will explore associated neural activity through functional magnetic~     resonance imaging (fMRI). Understanding how oxytocin influences these aspects of social~     functioning will help to inform research that has begun to establish the potential for use~     of this neuropeptide in education as well as psychiatric disorders such as autism spectrum~     disorders and schizophrenia that are characterized by social deficits.~      The investigators hypothesize that compared to placebo, oxytocin will improve deception~     detection, increase empathy and altruism, and enhance responses to photo stimuli of primary~     caregivers. These effects will manifest in behavioral and neural activity. It is also~     hypothesized that main effects will not be found for oxytocin, but rather, analyses of~     relevant moderators will elucidate these findings.~   "
50704|NCT02393443|"~     One well-established cognitive theory propose a divide between social and non-social (i.e.,~     cognitive) systems. However, recent work suggests that traditionally social systems can be~     utilized to enhance cognitive performance. In this study the investigators aim to explore~     this cooperation between oft-competing systems by instructing participants to learn~     information because they will be subsequently tested (the nonsocial learning-for-testing~     condition), or because they will be teaching the information to someone else (the prosocial~     learning-for-teaching condition). This latter condition relies upon the mentalizing system,~     which is used to contemplate another person's mental state, rather than traditional memory~     systems. This implies that the mnemonic powers of the mentalizing system can be leveraged in~     the learning of a broad array of non-social topics. Furthermore, there is also an emerging~     literature on the role of oxytocin, a neuropeptide naturally produced in the hypothalamus,~     in memory that parallels the social/nonsocial split. Oxytocin may benefit the~     learning-for-teaching group both in terms of enhancing initial social motivation and~     efficient use of the mentalizing system and then also in terms of memory consolidation for~     this information learning under socially-motivated conditions.~      The investigators expect to replicate the basic learning-for-teaching effect such that those~     in the teaching condition will remember more than those in the testing conditions. They also~     expect an interaction between oxytocin administration and learning condition such that~     oxytocin administration should enhance learning for socially-motivated learning exclusively.~   "
50705|NCT02393430|"~     To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients~     with chronic gastritis were randomly divided into the experimental group and the control~     group. The experimental group were treated with rebamipide 0.1g tid and optimization of life~     style, and the control group were only optimized their life style for 26 weeks. Upper~     gastrointestinal endoscopy was performed in all patients to evaluate the severity of~     gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system~     before and after treatment.~   "
50706|NCT02393417|"~     This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the~     exception of unblinded dedicated staff to handle study medication), phase 2a study with 3~     dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20~     weeks (10 doses administered every other week) or until a subject has complete resolution of~     all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a~     local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the~     length of the study to 29 weeks. Subjects will be followed for 4 months after final~     injection(s) for evidence of new or reoccurring warts and for safety evaluation.~   "
50707|NCT02393404|"~     Objective: To compare the effectiveness of functional movement-power training (PT-FMT),~     functional movement training (FMT) alone and no intervention in improving balance strategies~     and performance among children with developmental coordination disorder (DCD).~      Design: A randomised controlled clinical trial. Sample: 87 children with DCD. Interventions:~     12 weeks of PT and FMT or FMT alone in the two intervention groups.~      Major outcomes: Sensory organisation test - balance strategy and composite scores; Movement~     Assessment Battery for Children - total impairment score and balance subscore; hand-held~     dynamometer measurements of lower limb muscle strength and time to peak force.~   "
50708|NCT02393391|"~     Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous~     system, rather than stimulation of pain receptors. Diagnosis is suggested by pain out of~     proportion to tissue injury, dysesthesia (eg, burning, tingling), and signs of nerve injury~     detected during neurologic examination. Although neuropathic pain responds to opioids,~     treatment is often with adjuvant drugs (eg, antidepressants, anticonvulsants, baclofen,~     topical drugs). Neuropathic pain (e.g. phantom limb pain, CRPS, postherpetic neuralgia,~     postsurgical pain syndromes, CLBP etc.) remains a challenging condition to treat because it~     is commonly refractory to classical pharmacological and to surgical treatment approaches.~     Chronic low back pain (CLBP) is a widespread and costly problem for which few interventions~     are effective. An increased focus on the study of the nervous system and its involvement in~     pain disorders has documented complex neuronal activity and structural changes at a~     peripheral, as well as at spinal cord and cortical levels indicating a neuropathic element~     in CLBP. Accumulated evidence suggests that neuropathic pain in general and CLBP~     specifically might be associated to brain cortical plastic changes. Thus an ideal~     rehabilitative approach should aim to reverse them. In line with this idea, the~     investigators suggest an innovative noninvasive intervention aimed at alleviating~     neuropathic pain. New rehabilitative approaches have been proposed to try and reverse this~     cortical reorganization. Results of several studies have shown that motor cortex stimulation~     with epidural electrodes or repetitive transcranial magnetic stimulation (rTMS) or~     transcranial direct stimulation (tDCS) are effective in reducing pain in patients with~     central pain refractory to treatment. Transcranial direct current stimulation (tDCS) is an~     easily applied and safe technique by which brain activity can be modulated noninvasively and~     can decrease pain in patients with refractory central pain. The investigators hypothesized~     that focal-tDCS treatment personally customized to each patients basal neuronal network~     properties would result in both acute and long term pain relief for neuropathic pain~     patients.~   "
50709|NCT02393378|"~     The purpose of this study is to evaluate the efficacy and safety of namilumab in combination~     with existing methotrexate (MTX) over 24 weeks in patients with moderate to severe early~     rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX~     alone.~   "
50710|NCT02393365|"~     Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver~     that can lead to diminished liver function or liver failure.~      The number of chronically infected persons worldwide is estimated to be about 170 million~     that is 2.35% of the world population. Most people infected with the hepatitis C virus have~     no symptoms of the disease until the advanced stages of liver disease have occurred, which~     may take several years. The long-term impact of HCV infection is highly variable, from~     minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma~     (HCC).~      Advanced liver disease (ALD) can lead to significant clinical and economic consequences,~     including liver transplantation. HCV can reduce life expectancy and impair quality of life.~     HCV-related complications as well as the highly debilitating effects on patients represent a~     significant item of expenditure for the National Health Service. Because of the latency of~     infection, numerous country-specific population analyses suggest that HCV will cause an~     increasing number of liver-related deaths despite the dramatic drop in incidence and~     prevalence. These deaths will be related to prevalent HCV infection especially during and~     after World War II through indiscreet and widespread treatment with intravenous injection~     using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection~     can prevent the complications of HCV-related liver and extrahepatic diseases, including~     liver necroinflammation, fibrosis, cirrhosis, HCC, and death.~      Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA)~     like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C.~     Those new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment~     and fewer side effects. In a near future all patients should qualify for future all-oral~     therapies.~      However recent analysis have shown that increasing efficacy of treatment alone will not be~     able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and~     mortality can be obtained when higher efficacy therapies is combined with increased~     diagnosis and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90%~     decline in total infections by 2030. This would require a 3-5 fold increase in diagnosis~     and/or treatment for most countries.~      The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth~     cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to~     advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve~     quality of life.~      Robust data from public health surveillance, surveys of the general and risk populations are~     required to make decisions in allocating public health resources to diagnose, assess and~     treat HCV infection.~      In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV~     prevalence is 0.87% based on a study in the Flemish population published in 1997 but~     collected in 1994. In a French Belgian population there was an overall seroprevalence of~     0.6%. However, the population under study was not representative for the whole French~     community, because the recruited subjects were significantly younger.~      A survey among cirrhotic and hepatocellular patients in the French community revealed that~     20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis~     rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients~     remains undiagnosed.~      Several studies have already mentioned that aged population especially those born after~     Second World War are carriers of hepatitis C virus infection. Early detection of HCV~     infection and treating before progress to advanced liver disease (ALD) is an excellent~     opportunity to rationalize resource allocation and to improve patients' quality of life.~      Recently birth cohort screening recommendations were developed in the United States. In~     Belgium, no formal screening strategy exists. However the Belgian association of the study~     of the liver (BASL) recommends targeted HCV screening for high-risk populations (including~     individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal~     or IDU and dialysis patients) in addition to nontargeted screening among pre-operative~     patients and pregnant women. A birth cohort analysis based on a model suggests a birth~     cohort between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic~     population.~      In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium~     in 2014 and to confirm the proposed targeted birth cohort and other risk factors. These data~     could provide an efficient source of identifying newly diagnosed patients as part of a~     national screening strategy.~   "
50712|NCT02393339|"~     The aim of the study is to compare the efficacy of the pre-operative administration of~     Paracetamol and placebo in reducing postoperative pain after routine dental treatment in~     children. This study will be a prospective, placebo-controlled, randomized, double-blind~     trial. Patients in need of dental treatment with local anesthesia will take part in the~     study.~      Study group will receive syrup paracetamol 15 min before the dental treatment. Control group~     will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment.~     the patient, the treating dentist, and the interviewer will be blind to the medication.~      Main outcome measure: one of the main investigators will interview the patient at three time~     points: immediately at the end of the treatment, one hour after taking the pre-operative~     analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and~     his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no),~     needed a different kind of analgesics after the treatment (yes/no). In addition, each child~     will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial~     Rating Pain Scale~   "
50713|NCT02393326|"~     Objective: To compare success rates of biodentine partial pulpotomy versus formocresol~     pulpotomy treatment of pulpally exposed lower primary molars.~      After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated~     to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained,~     an assistant drew lots to randomly allocate the case to either the biodentine partial~     pulpotomy (PP) or the formocresol pulpotomy (FP) group.~      The follow-up for clinical and radiographic evaluation will be carried out at 6-month~     intervals.~   "
50714|NCT02393313|"~     This study evaluates the Rayner T-flex Toric IOLs for spherical and astigmatic correction,~     and rotational stability in cataract surgery. 50 patients with cataract and corneal~     astigmatism >= 2 diopters will undergo cataract surgery, with implantation of Rayner toric~     intraocular lens. Post-operative examination will include IOL axis measurements and~     refraction.~   "
50715|NCT02393300|"~     Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid~     (TXA) reduces blood loss and post-operative blood transfusion rate largely without major~     complications . In addition, many meta-analyses have confirmed these results . However,~     there is little information about comparison among the different routes of TXA~     administration in TKA. Therefore, this study has been designed to determine which~     administration route of TXA is more effective and safety.~   "
50716|NCT02393287|"~     The objective of this observatory is to evaluate the effecacy of Eribulin in patients with~     metastatic breast cancer on a recent prescription period.~      Part of the data collection will be retrospective and the other part will be prospective for~     patients started treatment by Eribulin between November 2014 and September 2015. It will~     allow a better assessment on the safety profile of this drug.~   "
50717|NCT02393274|"~     Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and~     respiratory support to patients with heart and respiratory failure. It can save time for~     these organs to recovery or for these patients to receive further management. However, many~     patients will die in spite of ECMO support. One of the key factor is whether the blood flow~     provided by the ECMO can meet the requirement of organ perfusion. The adequacy of~     macrocirculation may be determined by arterial pressure and minute blood flow of ECMO.~     However, the adequacy of microcirculation remains as a major unresolved clinical problem.~     This is a prospective observational clinical trial. The sublingual microcirculation will be~     examined with the incident dark field video microscope within 6 hours after venoarterial~     ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ~     injury and clinical data will be recorded as well. The major parameters of microcirculation~     include total small vessel density, perfused small vessel density, and microvascular flow~     index. The sublingual microcirculation will also be examined before weaning off ECMO, within~     6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial~     cell specific molecule-1 at specific time points will be examined. The data of 14-day~     mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be~     recorded. This study aims primarily to investigate the relationship between microcirculation~     and prognosis of these patients. This study will also investigate the relationship among~     serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of~     these patients. Wish the results of this study can be applied in further research to help to~     improve the quality of ECMO care.~   "
50718|NCT02393261|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml~     peritoneal dialysate.~   "
50719|NCT02393248|"~     The purpose of this study will be to evaluate the safety, tolerability, and pharmacological~     activity of INCB054828 in subjects with advanced malignancies. This study will have three~     parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).~   "
50720|NCT02393235|"~     Factors affecting the success of the treatment of infertility can evaluate before and after~     embryo transfer in two stages. Most of the patients reach the embryo transfer stage.~     Unfortunately, the investigators are able to intervene very few of the factors that will~     affect the success of the post-transfer. All factors and treatments that affect the~     implantation is vital to identify. Basically, healthy vasculature is essential for a~     successful implantation. The investigators will try to understand relationship between~     vascular resistance and type of infertility. The investigators will examine whether the~     effect of the ovarian uterine and spiral artery resistance over infertility.~   "
50721|NCT02393222|"~     Stroke disease and cognitive impairment are common in patients established on haemodialysis~     (HD) for end-stage renal disease (ESRD). Further, initiation of HD appears to transiently~     increase the risk of stroke. The mechanism by which this occurs is not known.~      Using ultrasound, patient questionnaires and brain MRI our study will observe changes in~     cognition and cerebral blood flow whilst receiving HD compared to a non-dialysis day.~     Transient clinical and ultrasound alterations will be correlated to radiographic changes in~     cerebral perfusion and structure on MRI to determine the underlying mechanism for the~     increased stroke risk. The investigators will observe this effect in the immediate and~     longer term (12 months observation).~      A greater understanding will allow development of effective preventive strategies.~   "
50752|NCT02392819|"~     This project evaluate effects of a commonly used food supplement on glucose metabolism and~     cognitive function.~   "
50722|NCT02393209|"~     The purpose of this study is to determine the recommended phase 2 dose (RP2D) of MLN1117~     when administered in combination with docetaxel in patients with non-small cell lung cancer~     (NSCLC) and to evaluate efficacy, safety, and tolerability of MLN1117 administered alone and~     in combination with docetaxel at the RP2D in patients with locally advanced or metastatic~     non-small cell lung cancer.~   "
50723|NCT02393196|"~     The investigators aimed to compare the methods colloid preloading and colloid coloading in~     terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second~     aim while planning the present study is to identify the method of the lowest adverse event~     for mother and infant and the simplest approach for the clinician.~   "
50724|NCT02393183|"~     This randomized clinical trial is designed to evaluate the effect of selected antioxidant~     vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit.~     Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg)~     +Mangeneschloride (1.8 mg) in patients with mild Graves' orbitopathy according to EUGOGO~     classification.~   "
50725|NCT02393170|"~     On-going rehabilitation is needed to maintain and improve the weaker upper extremity~     following stroke. Community rehabilitation programs for stroke individuals in the chronic~     stage are often difficult to be implement. Consequently, many individuals remain without~     structured interventional programs. Self-training programs, where individuals can~     independently continue to exercise at home, might answer this challenge. However, since~     exercising alone is boring and not motivating, individuals often stop the prescribed~     exercises and remain inactive. The use of video-games for self-training might answer this~     challenge.~      Therefore, the investigators aimed to assess the feasibility of using video-games for~     self-training after stroke. Specifically the investigators aim to compare the (1) training~     time, (2) satisfaction and (3) effectiveness of a self-training program using video-games~     compared to a traditional self-training program.~   "
50726|NCT02393157|"~     The purpose of this study is to determine the safety of administering obinutuzumab as a~     single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE)~     chemotherapy and determine the response rate of this treatment for children, adolescents and~     young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).~   "
50727|NCT02393144|"~     Primary aim of this study is to analyse contemporary labor patterns by measuring rate of~     dilatation and head descent via transperineal ultrasonography. Labor curves will be~     generated using data regarding rate of dilatation, head-descent obtained via transperineal~     ultrasonography. Factors which are known to effect duration of labor will be taken into~     account.~   "
50728|NCT02393131|"~     Brain metastases are the most common brain tumors in adults. It is estimated that around~     10-30% of cancer patients would develop brain metastases during the course of their illness.~      Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with~     brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in~     rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function~     decline caused by intracranial lesions. By using conventional fractionation, 33% of patients~     developed late neurocognitive toxicity while memory impairment was the most common symptom.~     The incidence is even higher when a formal and sensitive neurocognitive assessment was~     prospectively evaluated. With more long-term survivors nowadays, it has become increasingly~     important to minimize neurocognitive function decline and maintain quality of life in~     patients with brain metastasis.~      The function of hippocampus is cooperation in learning, consolidation and retrieval of~     information and essential for formation of new memories. Bilateral and unilateral radiation~     injury of the hippocampus is known to alter learning and memory formation. Several~     preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by~     ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is~     associated with subsequent neurocognitive function impairment in adult and pediatric~     patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG)~     0933 suggested hippocampal avoidance significant reduce the mean relative decline at 4~     months from 30% in historical cohort with WBRT to 7% in experimental cohort.~      Previous studies showed brain structures other than hippocampus are also associated with~     radiation-induced decline in neurocognitive function. There is presence of placebo effect~     for interventions seeking improvement in neurocognitive function. In present study, a single~     blind randomized phase II trial is designed to investigate the effectiveness of~     neurocognitive function preservation using conformal WBRT with or without hippocampal~     avoidance.~   "
50729|NCT02393118|"~     The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people~     who are profoundly blind. The BrainPort V200 translates images captured by a digital camera~     into electro-tactile stimulation presented on the user's tongue to perceive shape, size,~     location, and motion of objects within the environment. The purpose of this study is to~     evaluate the safety and functional performance of the BrainPort V200 device in individuals~     who have been medically documented as blind, light perception or worse, due to a traumatic~     injury (cortical or ocular).~   "
50730|NCT02393105|"~     This study explores the relationship between the sense of hope and fatigue in breast cancer~     survivors and provides a reference for future planning improvements for breast cancer~     survivors experiencing fatigue.~   "
50731|NCT02393092|"~     This study will evaluate the effectiveness of a hospital-community based violence prevention~     pilot study designed to increase protective factors and reduce negative risk factors~     associated with violence of children aged 10-15. Behaviors and attitudes that relate to~     violence and behavior change will be assessed through a series of questionnaires~     administered in an interview format. Assessments will occur every nine weeks. Additionally,~     objective long term measures for violence related hospital visits, delinquency, and~     educational development will be obtained.~      The study will include the following interventions:~        1. Brief violence prevention (BVP): a case manager administered psycho-educational~          intervention that will include an interactive discussion with youth regarding resources~          for remaining safe and preventing violence. The intervention will address the concerns~          and questions of youth and youth will be given information on how to access community~          based resources if needed.~        2. Brief violence awareness (BVA): a packet of information about violence prevention and~          local community resources.~        3. Emerging Leaders: East End: a semester (17 weeks) long curriculum based positive youth~          development education program held at the Boys and Girls Club of Metro Richmond, Martin~          Luther King Middle School site that includes case management to ensure continued~          engagement and participation.~      Specifically, it is hypothesized that:~        1. Participants will report more positive youth behaviors as compared to their initial~          assessment.~        2. Participants will report lower levels of risky youth behaviors compared to their~          initial assessment.~        3. Participants will report increased interest in and knowledge of health professions.~        4. Participants will report reduced levels of delinquency compared to their initial~          assessment.~        5. Participants will report a reduction in the number of violence related hospital visits~          compared to the general 23223 population.~        6. Hospital data will show a reduction in violence related activities that led to hospital~          visits, or delinquent behavioral involvement.~   "
50732|NCT02393079|"~     The purpose of this study is to evaluate the early and late effects of Transcranial Led~     Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI~     history in the initial phase (3-6 months).~   "
50753|NCT02392806|"~     Multiple different devices are available to provide Bubble CPAP to preterm and newborn~     infants. The most significant difference between these devices is the size of the bubble~     produced by the exhalation limb. This study will determine if one Bubble CPAP device~     (BabiPlus vs B&B) is more effective in improving oxygenation and decreasing extubation~     failure in the extremely low birthweight population.~   "
58144|NCT02296086|"~     The study will assess the difference in functionality between early vs. standard~     mobilization after hip fracture in the Chinese population.~   "
50733|NCT02393066|"~     This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor~     surgery were recruited to participate in the study. Apart from routine treatment in the~     surgical intensive care unit, the subjects were randomly divided into two groups: Propofol~     group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous~     infusion of Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion~     dosage range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic~     status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac~     Output and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h~     and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results,~     fluid volume and drugs used were also recorded.~   "
50734|NCT02393053|"~     Background: This randomized controlled clinical study of split-mouth aimed to compare~     non-pedicled buccal fat pad graft (BFPG) with subepithelial connective tissue graft (SCTG)~     in the treatment of Miller Class I or II gingival recessions.~      Methods: Twelve patients with Miller Class I or II (≥ 2 mm) bilateral recessions in~     maxillary premolars or canines were selected. The recessions were randomly assigned to~     receive SCTG (Control Group) or BFPG (Test Group). The clinical parameters of Gingival Index~     (GI), Plaque Index (PI), Probing Depth (PD), Gingival Recession (GR), Clinical Attachment~     Level (CAL), Width of Keratinized Tissue (WKT), Thickness of Keratinized Tissue (TKT) and~     Gingival Margin to the Acrylic Guide (GM-AG) were evaluated at baseline, and in the~     postoperative periods of 1, 3, and 6 months. The percentage of root coverage was also~     evaluated. Data were submitted to repeated measures ANOVA, Bonferroni method and t-test~     (p<0.05).~   "
50735|NCT02393040|"~     The purpose of this study is to determine the efficacy of treatment with Platelet-rich~     plasma on Androgenetic alopecia (compared with placebo), between six months and baseline.~   "
50736|NCT02393027|"~     Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic~     system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of~     striatal dopaminergic terminals (specially putaminal terminals).~      The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of~     presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the~     initial stages of the disease would lead to an early detection of nigral cell loss.~      Currently, only one DAT's radioligand has obtained marketing authorization in France, the~     123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).~      Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT~     with higher resolution has become for a few years the new gold standard for visual analysis~     and quantification of neurotransmission systems (including the dopaminergic system).~      A DAT tracer labelled with Carbon 11 ([11C] PE2l) have been developed and is currently used~     as a reference in various research centers.~      However, in order to enable a clinical use of this tracer (which currently can't be because~     of the too short period of Carbon 11), the unit INSERM U930 Imaging and Brain in~     collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals)~     developed a new version of this tracer, labelled with 18-fluor: the [18F] LBT-999.~      The main goal of this study is to compare the [18F] LBT-999 uptake between a group of~     patients suffering from a Parkinsonien syndrome to a group healthy volunteers.~   "
50737|NCT02393014|"~     This study aims to evaluate the feasibility and the impact on physical performance and falls~     occurence among geriatric inpatients hospitalized in acute care unit.~   "
50738|NCT02393001|"~     The purpose of this research study is to determine if a very sensitive chemistry lab~     analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.~   "
50739|NCT02392988|"~     In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in~     surplus pregnancies. It was found that after 41 weeks, there is a significant increase in~     pregnancy complications including meconium liquor, shoulder dystocia and fetal death in~     uterus.~      Induction at 41 weeks was found to reduce the risk of complications described above, without~     taking the risk of cesarean section and, therefore, the recommendation of the Israel Society~     of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of~     pregnancy.~      Induction is performed mechanically by entering a balloon to the cervix or by medicated~     prostaglandins and later, intravenous Pitocin to most women. The process takes two to three~     days with about 60-70% success rate.~      In recent years there has been a growing awareness to use natural methods to start labor.~      Many women tend to turn to natural medicine in order to reduce the need for conventional~     drugs to start labor.~      Given the lack of research on the issue and considering the rising demand of the involvement~     of alternative medicine in labor induction process, the investigators decided to carry out~     research on this subject.~   "
50740|NCT02392975|"~     This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young~     children with Traumatic brain Injury (TBI).~      In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency~     department visits in the US each year, making it a leading cause of pediatric disability and~     death. Currently 20-50% of these children undergo computed tomography (CT) scanning,~     exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are~     especially increased in children because the neurologic exam is less reliable, because~     growing tissues are more vulnerable to radiation, and because children have more years to~     accumulate harmful mutations.~      Fast MR is a short, motion-tolerant protocol that has been used in children with shunted~     hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast~     MR has not been validated in children with TBI, a critical gap. The investigators will~     measure feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old~     who undergo head CT for TBI.~      The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting~     subjects will undergo fast MR shortly after CT and results will be compared to determine: 1)~     whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR~     without sedation can be performed quickly and successfully.~   "
50741|NCT02392962|"~     All the athletes should perform a warm-up consisting of five minutes of jogging and static~     stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the~     beginning of the study and right after performing the stretching protocol, the investigators~     evaluated the unipedal postural stability, the acustic reaction time, the joint position~     sense of the knee and the countermovement jump of the athletes.~   "
79650|NCT02014883|"~     The purpose of this project is to study the efficacy of triheptanoin oil in patients with~     GLUT1 deficiency syndrome.~   "
50743|NCT02392936|"~     There is a recent increase in incidence of surgical site infection after cardiac surgery in~     our hospital, in spite of specific measures taken concerning some aspects of the surgical~     procedures, targeting a better control of the classically known major risk factors of~     infections, in routine procedures involving a sternotomy such as coronary artery bypass~     graft, valvuloplasty, aortic surgery, or combined procedures.~      The first objective of this monocentric prospective cohort study, is to evaluate~     underestimated specific risk factors of surgical site infection, during the perioperative~     period, for patients undergoing cardiac surgery with sternotomy.~      Secondly, to estimate the specific risk associated with each class or micro-organisms~     responsible, and their profile of resistance.~      The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in~     charge of the patient, one month and three months after surgery; it may concern the pre~     operative period, the procedure itself, or the early post operative period, characterized by~     a high density of cares, or even the late rehabilitation, after discharge of the surgical~     unit.~      Secondary outcome evaluate the profile of agents identified regarding the susceptibility of~     the prophylaxis recommended to prevent wound infection; it may suggest that an adequate~     antibiotic prophylaxis is often insufficient to take into account the responsible agents,~     and that decolonisation is not always that helpful, in view of emerging cases of failure due~     to developing resistance.~      Considering the low incidence of that type of complication, the investigators estimated that~     a period of two years might be necessary to include a sufficient number of patient, at least~     one thousand, in order to find a dozen of factors that might be significantly associated~     with an increased risk of surgical site infection.~      The evaluation is permitted by the collaboration between the anesthesiologists, surgeons,~     intensivists, hygienists, all along the presence of the patient in the department, until~     discharge out of the hospital and after readmission eventually for infectious complication.~   "
50744|NCT02392923|"~     Cohort descriptive study of quality of life and body functions in a reference population of~     Swedish inhabitants from age 30 to age 89. The population was selected to be representative~     for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.~      The population is contacted and asked for informed consent, whereafter a questionnaire of~     about 200 questions, used in a number of studies in clinical studies and trials, are sent~     out.~      The results will be used as reference values to our patient cohorts~   "
50745|NCT02392910|"~     Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well~     as impairing health-related quality of life in chronic heart failure (CHF), and these~     effects are compounded when patients also experience chronic kidney disease (CKD). This~     study was designed to determine the effects of intravenous iron treatment on morbidity and~     mortality following an initial 6-month period and a longer period of up to 5 years.~   "
50746|NCT02392897|"~     Eating frequency may play an independent role in appetite regulation, overall caloric~     consumption and measures of long-term health or disease risk. Some literature recommends~     frequent eating, but pilot data suggest that this type of eating pattern may be harmful to~     health since it leaves the body in a perpetual fed state and increases systemic~     inflammation. Therefore, the investigators will conduct a clinical trial in 50 healthy~     adults to compare a low frequency eating pattern to a high frequency eating pattern in~     relation to blood-based markers of inflammation, metabolic health and appetite. Study~     results will be applied to recommendations for eating frequency in the context of an overall~     healthy diet.~   "
50747|NCT02392884|"~     The purpose of this study is to determine whether cognitive rehabilitation or~     psychoeducation impacts medication adherence in HIV-1 seropositive individuals.~   "
50748|NCT02392871|"~     The purpose of this study is to investigate the side effects and safety, and effectiveness~     of combining dabrafenib and trametinib with radiotherapy.~      Previous and ongoing clinical trials have demonstrated the effectiveness and safety of~     combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the~     approval for the use of both drugs in combination in people with metastatic melanoma with~     the BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from~     radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that~     melanoma may be sensitive to radiotherapy and that it can help to improve quality of life.~      The intention of the CombiRT study is to establish if dabrafenib, trametinib and~     radiotherapy combined is a safe and effective treatment for metastatic melanoma.~   "
50749|NCT02392858|"~     Influenza is a major cause of morbidity and mortality. The investigators first goal is to~     evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death~     from Influenza respiratory illness in adult and pediatric patients hospitalized in~     reanimation. Secondly, the investigators collected respiratory samples in order to study the~     transcriptomic profiles of influenza-infected patients with severe symptoms.~   "
50750|NCT02392845|"~     To determine the maximum tolerated dose of a densified regimen of the association of~     docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of~     hematopoietic growth factors in patients with metastatic breast cancer in first-line,~     optimizing in each patient the administration schedule using a formal procedure based on~     mathematical models in order to manage the severity of induced neutropenia.~      The models used in this project allow:~        -  an optimal administration schedule of the planned total dose per cycle (number of~          infusions and calculating their rates and durations)~        -  an individualization of the administration schedule from the second cycle (based on~          observations from the first cycle), and~        -  an assessment of the risk of a dose-limiting toxicity event combining several severe~          non-hematological toxicities (conditioning the decision for dose escalation).~      Using formal mathematical models the investigators expect controlling the hematological and~     non-hematological toxicities in order to realize the full series of six cycles of densified~     DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is~     considered feasible if it is possible, in the absence of tumor progression, to consider 6~     cycles of treatment without observing any serious adverse events and without:~        -  patient death that may be related to the treatments;~        -  decision of the patient to interrupt treatment for physical or psychological tolerance~          reasons;~        -  decision of the investigator to discontinue treatment, in the absence of disease~          progression.~   "
50751|NCT02392832|"~     In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual~     spraying (IRS), together with the introduction of artemisinin-combination treatments, have~     led to substantial reductions in malaria prevalence and incidence in African highlands.~     However, rising insecticide resistance and increased outdoor transmission have greatly~     hampered the effectiveness of ITN and IRS because the current indoor-based interventions do~     not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can~     tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The~     central objective of this study is to determine the efficacy and cost-effectiveness of~     EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical~     malaria incidence in western Kenya highlands.~   "
50754|NCT02392793|"~     The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing~     DNA repair in damaged cells leading to their death. Investigators do not know if talazoparib~     combined with irinotecan will work in humans. Talazoparib has been used in only a small~     number of adults and children, and there is much not yet known about it.~      In Arm A of this study, investigators seek to find the safest dose of irinotecan to give~     with talazoparib to children and young adults. In a phase I study, different dose levels of~     drug may be tested. The first 2 or 3 patients will be given a dose, and if none of them has~     a bad side-effect, the next 2 or 3 patients will be given a higher dose. No temozolomide~     will be given in in Arm A.~      The experimental drug combination of talazoparib and irinotecan will be tested in the hopes~     of finding a treatment that may be effective against recurrent or refractory solid tumors.~     The goals of study Arm A are:~        -  To determine whether the combination of talazoparib and irinotecan is a beneficial~          treatment for your cancer;~        -  To learn what kind of side effects talazoparib can cause;~        -  To learn what kind of side effects talazoparib in combination with irinotecan can~          cause;~        -  To learn more about the biology of talazoparib in children diagnosed with solid tumors.~      The purpose of Arm B is to to find the safest doses of irinotecan and temozolomide to give~     with talazoparib to children and young adults with a solid malignancy.. Talazoparib belongs~     to a family of drugs called poly ADP ribose polymerase or PARP inhibitors. Irinotecan and~     temozolomide belong to a family of drugs called DNA damaging agents.~      There are two arms of this trial, A and B. In this study, investigators hope that irinotecan~     (administered in Arm A) and irinotecan plus temozolomide (administered in Arm B) will damage~     the DNA of the cancer cells. Then, talazoparib (which is a PARP inhibitor) will block the~     repair of the cancer cell's damaged DNA, causing the cancer cell to die (a process called~     apoptosis).~      There are different types of cancers found in children and young adults which appear to be~     vulnerable to the combination of chemotherapy agents that will be given in this study. Work~     carried out in the lab show that these agents may be very promising in the treatment of~     ewing sarcoma, germ cell tumors, wilms tumor, medulloblastoma and possibly neuroblastoma.~   "
50755|NCT02392780|"~     Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic~     cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis~     sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent~     phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of~     acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results~     the investigators propose a phase 2 study to explore the efficacy of oral CBD in the~     treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.~   "
50756|NCT02392767|"~     The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2,~     R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double~     blind placebo-controlled cross-over study. Volunteers with hypertension and~     hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.~   "
50757|NCT02392754|"~     Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to~     detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring~     technologies have the potential to improve early detection of AF. This trial investigates AF~     screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor~     that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home~     blood pressure monitor that has built-in AF screening capability.~   "
50758|NCT02392741|"~     This study aims to determine the effect of a physical exercise program on microcirculation~     and maternal and perinatal outcomes in obese women. A randomized clinical trial will be~     performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral~     Professor Fernando Figueira (IMIP) prenatal service.~   "
50759|NCT02392728|"~     The mood disturbances that lung cancer patients experience during and after chemotherapy~     have a debilitating effect on their quality of life. The goal of the proposed project is to~     develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to~     combat the adverse psychological/emotional consequences of receiving treatment for lung~     cancer. Although VR has been used with success to treat various psychological conditions~     (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood~     and hence better quality of life has not yet been tested. In this project the investigators~     will first develop the virtual content (e.g., natural scenes) that patients will experience~     within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The~     investigators will then carry out a randomized, double blind, crossover trial with 50~     hospitalized lung cancer patients to test whether they can benefit psychologically and~     emotionally from their interaction with an immersive environment compared to those who will~     experience a guided imagery intervention. A positive result will open the route for the~     future development of affordable self-administered VR solutions for treating the~     psychological side-effects of lung cancer treatment.~   "
50760|NCT02392715|"~     Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing~     prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner~     stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases~     dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary~     benefit in the rehabilitation of COPD patients is however uncertain.~   "
50761|NCT02392702|"~     This two-part study will assess, in healthy volunteers, under both fasted and fed~     conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK)~     profile of single doses of C-10355 and C-10358 and single ascending doses of the selected~     compound compared to a single dose of Kalydeco®.~   "
50762|NCT02392689|"~     Patients presenting to the Emergency Department with shortness of breath and (suspected)~     heart failure will be screened and randomized to either a standard of care or a~     procalcitonin-guided arm.~      Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support~     decision on antibiotic therapy initiation.~      Standard of care arm: the decision on antibiotic therapy will be based on the physicians~     intent to treat.~      The patients will be followed up 30 and 90 days after randomization to evaluate the survival~     status, re-hospitalizations and further antibiotic therapies.~   "
50763|NCT02392676|"~     Olaparib administered as monotherapy in the maintenance setting improves progression free~     survival compared to placebo in patients whose tumours carry loss of function (deleterious~     or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or~     suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR)~     -associated genes who have a complete or partial response to platinum-based chemotherapy.~   "
50764|NCT02392663|"~     This study aims to analyze whether the hypertonic saline nebulization enhances sputum~     clearance effects, reduces the impact on cough severity and their level of safety and~     tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition,~     this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic~     saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).~   "
50779|NCT02392468|"~     Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate~     the ocular and systemic safety and pharmacokinetics during 14 day treatment period in~     patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.~   "
50765|NCT02392650|"~     Hominids and hominins serve as remarkable hosts to microbes, and we have co-evolved over the~     past 4.5 million years as highly plethoric communities. Human-associated microorganisms (the~     microbiome) are present in numbers exceeding the quantities of human cells by at least~     10-fold beginning in the neonatal period. The collective genome (the metagenome) exceeds~     our human genome in terms of gene content by more than 150-fold. With respect to microbiota~     and preterm birth, it has generally assumed that the majority of intrauterine infections~     originate in the lower genital tract, with microbiota ascending into the otherwise sterile~     intrauterine environment to infect the placenta (preterm birth), fetal membranes~     (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and~     others have recently demonstrated that the vaginal and gut microbiome communities are~     distinctly structured in pregnancy, and the placenta is in fact not sterile, but rather~     harbors a low-abundance microbiome which is likely acquired through hematogenous~     transmission of the oral microbiome.~      Based on our prior studies and preliminary data, our central hypothesis is that a distinct~     and largely commensal resident microbiome in pregnancy renders risk for preterm birth. By~     utilizing our state-of-the-science technology and analysis tools in a longitudinal~     case-cohort of preterm birth subjects, we will be able to transform discovery based~     metagenomics and multi'omics science into readily translatable mechanistic studies at a~     previously unparalleled level.~   "
50766|NCT02392637|"~     The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to~     gemcitabine and cisplatin can help to control metastatic (has spread) or unresectable~     (cannot be removed by surgery) biliary cancer. The safety of this drug combination will also~     be studied.~   "
50767|NCT02392624|"~     This randomized, double-blind, placebo-controlled study will evaluate efficacy and safety of~     subcutaneous omalizumab as an add-on therapy through 48 weeks. After completing an initial~     24-week open-label treatment period with omalizumab 300 mg every 4 weeks, participants~     responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either~     continue omalizumab or be transitioned to placebo for a further 24 weeks.~   "
50768|NCT02392611|"~     This study will evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of GS-5829 in adults with advanced solid tumors and lymphomas and in~     combination with exemestane or fulvestrant in adults with estrogen receptor positive breast~     cancer.~   "
50769|NCT02392598|"~     This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of~     patients with chronic hepatitis B.~   "
50770|NCT02392585|"~     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss~     at open myomectomy.~   "
50771|NCT02392572|"~     The goal of Phase I of this clinical research study is to find the highest tolerable dose of~     ONC201 that can be given to patients with relapsed or refractory AML, ALL, or MDS.~      The goal of Phase II of this study is to learn if the dose of ONC201 found in Phase I can~     help to control the disease. The safety of the study drug will be studied in both phases of~     this study. This is the first study using ONC201 in humans. ONC201 is in a very early stage~     of development for use in humans. Providing direct medical benefit to you is not the purpose~     of this study. While Phase II will look at the effectiveness of the study drug, the main~     purpose of this study is to learn about the safety of the drug.~   "
50772|NCT02392559|"~     A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged~     10-17 years diagnosed with heterozygous familial hypercholesterolemia.~   "
50773|NCT02392546|"~     This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic~     constipation. The purpose of the study is to compare the effects of daily single-dose oral~     elobixibat and placebo for 7 days on colonic motor effects.~   "
50774|NCT02392533|"~     Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the~     fetus, making patients familiar and comfortable with its usage. Ultrasonography does not~     result in adverse effects to the mother or fetus and is readily available at most~     facilities, yet is not routinely used to identify lumbar interspaces prior to providing~     neuraxial anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar~     intervertebral spaces and is more accurate than simple palpation of obscure anatomic~     landmarks. The investigators are interested to know the accuracy of anatomic landmark~     palpation in predicting the lumbar interspace of neuraxial anesthesia administration~     compared to identification of the interspace by ultrasound. The investigators are also~     interested in presenting anesthesia providers with feedback regarding their accuracy and~     then investigating whether this feedback causes a change in provider practice (i.e. use of~     ultrasound) or improved identification of the interspace prior to providing neuraxial~     anesthesia.~   "
50775|NCT02392520|"~     The study aims to compare the novel method of GnRH antagonist administration in the luteal~     phase versus conventional treatment in IVF patients who develop severe early ovarian~     hyperstimulation syndrome and have all their embryos cryopreserved.~   "
50776|NCT02392507|"~     The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus~     necitumumab is effective and safe in participants with stage IV squamous non-small cell lung~     cancer.~   "
50777|NCT02392494|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to~     determine the ability of MK-1075 to reduce HCV viral load, following administration of a~     single dose in HCV-infected participants.~   "
50778|NCT02392481|"~     The main objective of the trial is to explore if any of the biomarkers assessed are~     sensitively linked to the asthma phenotypes. This would potentially alone or in addition to~     other clinical or biofluid markers indicate if and how asthma endotypes are linked to~     phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further~     exploratory markers will be analysed for better understanding of physiological levels of~     proteins and markers playing a role in regard to disease characterization in asthma. As a~     basis for further development of a biomarker for asthma, The sponsor plans to conduct this~     exploratory biomarker trial to determine levels and reference ranges of biomarkers~     potentially associated with asthma phenotypes. The trial aims at generating a panel of serum~     biomarkers that can be evaluated in subsequent interventional studies. The longitudinal~     design will be used to ascertain stability and test-retest reliability.~   "
51154|NCT02387554|"~     The purpose of this study is to investigate the pharmacokinetic interaction and safety~     between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy~     male volunteers~   "
50780|NCT02392455|"~     This observational study will investigate the efficacy and tolerability of Vargatef~     (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally~     advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC~     patients, for whom the treating physician has decided to initiate treatment with Vargatef in~     second line according to the local label, will be observed for up to 24 months. Survial~     follow-up will be done until the end of the study.~   "
50781|NCT02392442|"~     Background:~      - When bacteria enter the lungs, serious infections can occur. Researchers want to learn~     more about the process of inflammation in the lungs by studying lung cells and the products~     that they make. Lung cells are influenced by infections, smoking, and molecules made within~     the body. Researchers also want to learn more about one of these molecules, called microRNA~     (or micro ribonucleic acid).~      Objective:~      - To better how the body responds to infection. Also, to understand which cells in the lung~     secrete microRNA and how they may influence other lung cells.~      Eligibility:~      - Healthy, non-smoking adults ages 18-45.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests and an electrocardiogram.~        -  Participants will have blood drawn from an arm vein. They will have an intravenous~          catheter (small plastic tube) placed in a vein.~        -  All participants will have bronchoscopy with bronchoalveolar lavage. They will be~          numbed with medicine. A thin flexible tube will be placed through the nasal passages or~          the mouth into the airways of the lung.~             -  Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the~               airways with salt water) in order to obtain cells from lung. The water will then~               be suctioned out.~             -  Some participants will have two bronchoscopies; during the first procedure,~               endotoxin, a molecule found in bacteria is squirted into a small portion of the~               lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6~               to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at~               the lung s response to endotoxin.~        -  Participants heart rhythm and rate, temperature and blood oxygen level will be~          monitored during the procedures.~        -  Participants will be called the next day to see how they are feeling.~   "
50782|NCT02392429|"~     This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography~     (PET)/computed tomography (CT) in measuring response in patients with previously untreated~     acute myeloid leukemia. FLT is a radioactive substance that may light up where cancer is~     in the body. FLT is injected into the blood and builds up in cells that are dividing,~     including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's~     response to earlier treatment.~   "
50783|NCT02392416|"~     Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart~     Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias)~     These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation~     and taking into account specific parameters in the patient's profile.~   "
50784|NCT02392403|"~     The aim of this study is to investigate the clinical benefit for patients implanted with the~     Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode~     design.~      Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the~     cochlea through a straightening sheath.~   "
50785|NCT02392390|"~     The main objective of this study is to estimate the change in the relative numbers of~     commensal or low virulence potential bacteria before and after one session TDP.~   "
50786|NCT02392377|"~     This randomized pilot phase II trial studies how well molecular phenotyping works in~     predicting response in patients with stage IB-III esophageal cancer who are receiving~     carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying~     the genes in a patients tumor cells before, during, and after chemotherapy may help in~     understanding if there are specific features of the tumor cells that make a person more or~     less likely to respond to treatment and how these features may be affected by treatment.~   "
50787|NCT02392364|"~     The purpose of this study is to compare the safety and efficacy of intravitreal Eylea~     injections at a set interval, versus a variable dosing schedule (likely longer than one~     month), based on a specific individual's disease progression. There will be approximately 50~     men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking~     part in this study at 5 locations in the United States.~   "
50788|NCT02392351|"~     The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™~     Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment~     office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8~     weeks when compared to a masked procedure (renal angiogram).~   "
50789|NCT02392338|"~     In this study, the investigators therefore comparatively analyzed the mid-term results (at 1~     year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term~     electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid~     procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic~     medication, discontinuation of anticoagulation medication, and echocardiographic findings~     were also analyzed.~   "
50790|NCT02392325|"~     Dengue viruses infect millions of people throughout the tropics and subtropics each year.~     The development of a dengue vaccine is an important health priority. This study will~     evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart,~     in healthy adults with no history of previous flavivirus infection.~   "
50791|NCT02392312|"~     A multicenter, prospective, observational study to evaluate the safety and efficacy of~     individual batches of ATG-F in kidney transplant recipients.~   "
50792|NCT02392299|"~     The purpose of this study is to explore the relative importance of the frailty and~     cardiovascular function as potential exercise-modifiable risk factors for falling in~     patients receiving haemodialysis.~   "
50793|NCT02392286|"~     Prospective randomized comparative effectiveness trial designed to compare fixed dosing and~     weight-based dosing of corticosteroids in patients with Crohn's disease flares.~   "
50794|NCT02392273|"~     This study is an observational study with the primary objective to assess the safety and~     tolerability of Ausanil in the treatment of primary headache disorders. The secondary~     objective is to assess headache pain, functional outcome, time loss to headache and patient~     satisfaction with Ausanil treatment.~   "
50803|NCT02392156|"~     The primary objective of the study is to evaluate the effectiveness of prophylactic~     treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor~     IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health~     economic outcomes while maintaining disease control in males with hemophilia A or B.~   "
50804|NCT02392143|"~     The purpose of this study (Healthy Colon Project II) is to evaluate different educational~     approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach~     urban minority population with health insurance.~   "
50805|NCT02392130|"~     The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin~     thickness in healthy skin treated with steroid.~   "
50795|NCT02392260|"~     This project is part of the EU funded project NISTAS. NISTAS aims at the development of a~     new medical device for non-contact, non-invasive screening of the health status of the~     vascular system of adult subjects. The instrument, called VascuLight, is intended to be~     deployed at out-patient points-of-care and hospitals, and it provides output parameters~     related to the PWV as measured at local and/or at regional level.~      NISTAS brings together four European SMEs in four different, but complementary, technology~     areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV,~     OSM, CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical~     device which will have significant commercial benefits for all of the SME partners.~      VascuLight responds to an unmet need in the medical diagnosis practice: the request for a~     fast and sustainable method for the screening of the health of the vascular system in large~     series, capable of providing a reliable indicator of the cardiovascular risk of the screened~     subjects.~      The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical~     field measurement techniques that are to date confined to the industrial environment. NISTAS~     will develop new non-contact distance/displacement/vibration sensors based on a variant of~     the well-known and reliable laser triangulation technique.~      JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to~     demonstrate that the concept is realistic and attainable. Results have been obtained using~     Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of~     light interference, and an area where both JUL and UNIPV have made important contributions.~     In the tests it was possible to use TWO small LDV optical heads to simultaneously measure~     the pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation~     of the time-delay between the pulse waves, and thus providing a direct local measurement of~     the PWV.~      The aim of the study is to test the implemented contactless optical technique for the~     measurement of the PWV and the arterial stiffness at the carotid artery level.~      To evaluate the validity of the measure method, the investigators will compare Vasculight~     v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main~     idea is to compare the distribution of measures (comparable mean and standard deviation) in~     the same mixed adult population, using the two different methods.~   "
50796|NCT02392247|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine~     blood draws in cardiac surgery patients.~   "
50797|NCT02392234|"~     The purpose of this study is to evaluate the efficacy of VX-661 in combination with~     ivacaftor and ivacaftor monotherapy in subjects with Cystic Fibrosis (CF).~   "
50798|NCT02392221|"~     Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease~     (IBD) and may affect all segments of the digestive tract. These are diseases of~     multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD~     registry, the world's largest epidemiological register for IBD, identifying all incident~     cases in the four departments of the North West of France showed between 1988 and 2007, an~     increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p~     <0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC~     decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation~     remained stable. The increase in the incidence of CD will contribute to increase its weight~     in the health system, particularly in the pediatric CD frequently associated with an~     aggressive phenotype causing specific complications such as malnutrition, pubertal delay or~     thrive. These complications have a important impact on the quality of life with a long-term~     risk of functional disability. They may be associated with increased mortality.~     Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from~     the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new~     therapeutic classes have profoundly changed the management of pediatric IBD. Although there~     is little data on the impact of these new treatments, early introduction of~     immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in~     pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission.~     With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal~     healing and more recently the deep remission combining clinical remission, biological and~     endoscopic, appears. However there is no data in the general population assessing the impact~     of new treatments and new therapeutic strategies in the pediatric population. Potential~     risks associated with the increasing use and early use of biological treatments in this~     particular population remain to be determined in the general population.~      The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed~     before 17 yeras old could influence the cumulative incidence of surgical resection and~     complications specific to this population as failure to thrive and delayed puberty,~     insertion socio-professional, the extension of the disease, hospitalization rates, and the~     rate of cancer.~   "
50799|NCT02392208|"~     Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an~     increased risk for developing bloodstream infections. Vancomycin is traditionally used as~     first-line therapy for treating these infections, but the emergence of less-susceptible~     bacterial strains necessitates the consideration of alternative antibiotic therapy.~     Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against~     gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While~     dosing recommendations for telavancin are available for patients with normal kidney~     function, there are no published recommendations for CKD5 patients receiving hemodialysis. A~     pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin~     in these patients to determine the extent of drug removal by hemodialysis and to establish~     dosing recommendations for CKD5 patients on maintenance hemodialysis.~   "
50800|NCT02392195|"~     This study will enable investigators to find out if brain structure and characteristics are~     affected by the shape of the infant's head, and if changes in the brain occur with helmet~     therapy.~   "
50801|NCT02392182|"~     In its original phase, this cohort study recruited subjects who were either HIV-positive or~     HIV-negative healthy controls, to analyze the community structure of the lung microbiome.~     Original recruitment was planned to occur both at the University of Michigan Medical Center~     and clinics, and at VA Ann Arbor Healthcare System.~      Enrollment for the original cohort is completed, and all current activity of this project is~     occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible~     to participate. This study is currently recruiting only healthy HIV-negative subjects.~     Participation, described below, involves a research bronchoscopy procedure.~   "
50802|NCT02392169|"~     Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and~     adolescent psychiatric disorders. In recent years, some researchers have become interested~     in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone~     (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in~     ADHD has established a strong heritable component to the phenotype. The STS gene, SULT2A1~     gene and TH gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is~     associated with the regulation of cortisol. Therefore, the relationship between these genes~     and the etiology of ADHD warrants investigation. Moreover, compared to the phenotype, the~     endophenotypes of ADHD may be more capable of detecting the underlying neurobiological and~     hereditary mechanisms. Therefore, this study aims to investigate the relationships between~     neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS~     gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease~     subtypes, neurocognitive function and response to treatment) of ADHD.~      To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological~     parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline,~     saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive~     drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo~     assessment for their clinical symptoms and neurocognitive function. Methylphenidate will~     then be administered to the patients and the usual practice followed. At week 4 and week 52,~     procedures similar to those performed at baseline will be repeated.~      The results of this study may further elucidate the complexity of the pathophysiology of~     ADHD. We may determine whether the neuroendocrine system, which contains levels of~     neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and~     endophenotypes of ADHD. The information may serve as an important reference for the~     direction of future study and clinical treatment for patients with ADHD.~   "
50806|NCT02392117|"~     This study is conducted in Europe. The aim of this non-interventional study is to~     investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world~     population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.~   "
50807|NCT02392104|"~     The purpose of this study is to determine the feasibility, safety, and acceptability of~     implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin~     in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.~      All participants will be provided usual care from the anticoagulation clinic, except for the~     interval between INRs. If the participant continues to be on a stable dose of warfarin and~     the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will~     be scheduled following an extended interval protocol. Patient satisfaction will be evaluated~     at various points throughout the study. Additionally provider satisfaction, confidence, and~     knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic~     events will be evaluated to ensure the safety of an extended follow-up interval.~   "
50808|NCT02392091|"~     The aim of this study was to investigate the prevalence, type, and possible risk factors of~     RTA in critically ill patients using a physical-chemical approach.~   "
50809|NCT02392078|"~     The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that~     is being manufactured by Monteris Medical. Since it received FDA clearance in April 2013,~     the NBS has been used in over 300 procedures conducted at approximately 20 leading~     institutions across United States. This is a prospective, multi-center registry that will~     include data collection up to 12 months to evaluate procedural success, local control~     failure rate, and QoL in up to 1,000 patients and up to 50 sites.~   "
50810|NCT02392065|"~     To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery~     population and establish links between COPD status, as assessed through pulmonary functional~     tests, and 2-year mortality~   "
50811|NCT02392052|"~     Spinal cord injury (SCI) may result in physical deficits that require assistance from others~     in order to stay healthy and live independently in a community. The assistance provided by~     caregivers to a family member with SCI often involves a wide range of activities from~     helping with basic activities, like toileting and bathing, to managing more complex tasks,~     such as keeping up with household finances, shopping, and transportation. Caregiving puts~     demands on an individual's ability to cope and deal with day-to-day stresses, and may be~     influenced by personal beliefs about one's ability to cope with stress. Beliefs about our~     ability to perform tasks that affect our lives have been termed self-efficacy. A strong~     sense of self-efficacy has been shown to positively impact life choices, motivation, quality~     of functioning, resilience to adversity, and vulnerability to stress and depression. People~     with low self-efficacy tend to avoid challenges, discontinue tasks that are difficult, and~     be at risk for more depression and stress, resulting in less satisfaction with life.~      This study uses a psychological strategy, called cognitive behavioral therapy (CBT), to~     enhance self-efficacy skills for caregivers of family members with SCI, with a focus on~     changing thinking styles to help people make emotional and behavioral changes. The~     investigators hypothesize that by providing family caregivers with a six week group~     educational intervention, their self-efficacy skills as well as general life satisfaction~     can be improved, and minimize depression, stress and anxiety that often accompany the~     caregiving role. The innovation of the proposed intervention is its integration of positive~     psychotherapy concepts into structured group CBT to develop optimistic self-efficacy~     beliefs, strengthen the caregiver's ability to deal with day-to-day stress, and enhance a~     sense of well-being in the caregiver which, in turn, may benefit the family member with SCI.~   "
50812|NCT02392039|"~     The goal of this clinical research study is to learn if loratadine can control bone pain~     caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell~     counts).~   "
50813|NCT02392026|"~     Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal~     Gel in females 12 to <18 years for the treatment of bacterial vaginosis.~   "
50814|NCT02392013|"~     This study evaluates the effectiveness and implementation of a home-hazard removal program~     to reduce falls in older adults through a community program delivered through the aging~     services network. The investigators will conduct a hybrid effectiveness/implementation trial~     of 300 older adults at risk for a fall who will be randomized to a home-hazard removal~     program or usual care and then followed for 12 months.~   "
50815|NCT02392000|"~     Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia~     (trouble falling or staying asleep). Most current interventions for insomnia are~     time-consuming, making it difficult for this younger, working group of Veterans to use and~     benefit from these interventions. The investigators will assess whether Veterans find it~     helpful to use two health information technology tools, one for measuring participant sleep~     (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will~     measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile~     health application used on the Veteran's mobile phone or tablet to teach skills that can~     reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so~     Veterans can self-manage insomnia at home. Participants will record their physiological~     sleep and self-report on their sleep at home during a 6 week self-management program. The~     investigators will measure if Veterans find the tools helpful and easy to use, and which~     Veterans find the tools most helpful.~   "
50816|NCT02391987|"~     This study evaluates the effectiveness of remote tele-monitoring and health coaching in~     helping to reduce hospitalizations in heart failure patients. Half of participants will~     receive tele-monitoring and health coaching, while the other half will receive standard~     health care provided by their chosen provider.~   "
50817|NCT02391974|"~     This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.~      In addition to the standard periodontal treatment procedure on all teeth that need to be~     treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to~     either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.~      The pocket depth will be measured at six sites around each tooth, and only the deepest~     pocket sites of each tooth will be taken into account.~   "
50818|NCT02391961|"~     Primary fatigue represents a major cause of disability in patients with multiple sclerosis~     (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning~     but, unfortunately, little is known about its mechanisms. The investigators propose a~     characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly~     encountered in MS, as a simple model for primary motor fatigue. The investigators described~     worsening of ocular performance in MS patients with INO following visual tasks (ocular motor~     fatigue), which is likely due to decreased neural conduction along brain pathways injured by~     MS. This mechanism could represent a major component of MS-related primary motor fatigue.~     Relevant to Veterans' care, INO is a significant cause of visual disability, especially when~     complicated by ocular fatigue, and limits daily activities such as reading and driving. The~     investigators propose a medical treatment to improve ocular performance/fatigue in INO,~     which can reduce visual disability and improve quality of life in Veterans with MS.~   "
50819|NCT02391948|"~     The On Track Study is a large multi-site collaboration involving researchers, therapists,~     families, and children with cerebral palsy (CP) from across Canada and the United States.~     The researchers need to better understand how young children who have difficulties with~     movement activities progress and develop in their balance abilities, fitness, strength,~     health, range of motion, self-care, everyday play, and activity participation.~      This study will determine how young children with cerebral palsy or gross motor delays~     progress in many aspects of their physical development and participation in daily life. The~     information collected from this study will help therapists and parents monitor if a child is~     developing as expected in his or her physical development and participation. Then, the~     health care professionals working with children can use the results of this study, in~     combination with the previously completed Move & PLAY study results, to provide the services~     that are most beneficial and meaningful for each child and their family members.~   "
50820|NCT02391935|"~     The primary purpose of this study is to assess the safety profile of RCS-01 injections as~     compared to placebo injections. This study will also measure the impact these injections~     will have on skin markers related to aging through evaluation of gene expression profiles.~      30 participants will be selected for this study based on their health status, current/past~     medications, and ability to adhere to protocol-related requirements. At the first visit and~     after providing informed consent, participants are evaluated against the study~     inclusion/exclusion criteria and provide blood samples for screening assessments (including~     virology). If suitable for study participation, participants will provide a biopsy from the~     scalp from which RCS-01 will be prepared and will have four treatment evaluation sites~     identified on their buttocks, two on each side.~      Study participants will be randomized to one of two treatment subgroups. Participants in the~     RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a~     needle penetration without injection of liquid). Participants in the the Placebo Subgroup~     (n= 6) will be randomized to receive only injections of placebo or sham injections.~      Baseline evaluations of subjects' overall health and skin condition at treatment sites on~     their buttocks will be performed before receipt of injections at Day 0. In addition to~     injections delivered at Day 0, the pre-selected treatment evaluation sites will receive~     intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and~     eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3)~     injections per treatment site.~      All participants will return to the clinic for at least 10 visits during the 104-week~     follow-up period to monitor long-term safety. At the 12-week time point, 18~     randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all~     injection sites for analysis of skin markers related to aging. At the 26-week time point,~     the remaining participants will provide biopsies of all injection sites for~     histopathological analysis.~   "
50821|NCT02391922|"~     The study evaluates the effect of a first aid course on first aid skills compared to no~     training. The study also evaluates the effect of first-aid instructions given by emergency~     dispatch central over mobile phone on first aid performance to no instructions.~      Half the participants will perform first aid in two scenarios prior to first aid training.~     Half the participants will perform first aid in two scenarios 4 to 5 months after attending~     a first aid course. Half the participants (overall) will receive first aid instructions by~     mobile phone during the scenarios.~   "
50822|NCT02391909|"~     This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in~     healthy adult male and female travelers for whom typhoid vaccination with Vivotif is~     recommended, as per standard practice.~   "
50823|NCT02391896|"~     Computed tomography (CT) is the most accurate test for evaluating patients with thoracic~     disease. However, access to CT is limited due to long wait times and for the sickest~     patients in Hospital who cannot be transported from the ward to the CT scanner. The~     investigators propose to modify a standard X-ray unit to provide more detailed information~     of the chest such that a CT scan is not required for all patients.~   "
50824|NCT02391883|"~     Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual~     Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the~     dilemma of putting the patient at risk of a major blood loss during and after surgery, or~     putting the patient at risk of a thromboembolic event after surgery. The investigators~     hypothesize that the risk of a major blood loss in patients that are still under the effect~     of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The~     investigators have conducted a retrospective observational study on hip-fracture patients to~     test this hypothesis.~   "
50825|NCT02391870|"~     Pregnant women with histories of depression are at high risk of depressive relapse during~     the perinatal period, and options for relapse prevention are limited. Mindfulness-based~     cognitive therapy (MBCT) has strong evidence among general populations but has not been~     studied among at risk pregnant women.~      This study is the first phase of a multi-phase project adapting MBCT for perinatal women~     (MBCT-PD). It is being conducted in a collaboration between the University of Colorado,~     Emory University, and Kaiser Permanente at Colorado and Georgia.~   "
50826|NCT02391857|"~     This study aimed to identify the effect of early gastric decompression on the improvement of~     circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting~     of emergency department.~   "
50827|NCT02391844|"~     This is a pilot trial using this product in patients for the management of pain after~     outpatient arthroscopic knee surgery. This is an open-label study and the two active~     ingredients are well known pharmacologic entities.~   "
50828|NCT02391831|"~     NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of~     patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to~     characterize the disease course over 2 years and identify prognostic variables of the~     disease and biomarkers of SMA progression, as well as determine the best outcome measures~     for further therapeutics approaches.~   "
50829|NCT02391818|"~     The purpose of this study is to quantify the balance impairments during and after taxane~     chemotherapy. Disability due to balance impairments caused by chemotherapy induced~     peripheral neuropathy (CIPN) can cause falls, injury, and a decline in independence. This~     results in poor treatment outcomes such as greater morbidity and mortality, inability to~     complete treatment protocols, self-limitation of activity, and diminished quality of life.~   "
50830|NCT02391805|"~     This randomized, multicenter, partially double-blind, placebo-controlled study is designed~     to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral~     effects of treatment with RO6864018 in virologically suppressed participants with chronic~     HBV infection.~   "
50831|NCT02391792|"~     Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell~     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with~     merging role in pathophysiology of immune and cardiovascular diseases. MPs have been~     characterized during septic shock and may contribute to dissemination of pro-inflammatory~     and procoagulant mediators. This a prospective observational study of circulating MPs and~     blood coagulation in septic shock patients admitted in medical intensive care units (ICUs)~     of four tertiary hospitals at baseline (D1, D2, D3, D4, D7).~   "
50832|NCT02391779|"~     Current recommendations today suggest that use of therapeutic lifestyle changes, such as~     supplementation with specific dietary components and moderate exercise, are appropriate~     interventions for individuals with borderline high blood pressure. Dietary intervention with~     natural products, such as flaxseed, is associated with decreased prevalence of~     cardiovascular disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed~     to mediate the cardiovascular health benefits following flaxseed consumption (Peterson~     2010). Clinical trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax®~     from Archer Daniels Midland, a natural product derived from flaxseed composed of 34-38%~     lignan) for reducing blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure~     (Cornish 2009). Furthermore, a recent study in atherosclerosis patients showed significant~     clinical benefit of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a~     therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly~     patients, the effectiveness of FLC supplementation alone or in combination with moderate~     exercise merits investigation.~   "
50833|NCT02391766|"~     After diagnosis of a dementing illness, patients and their spouses have many concerns~     related to the disease and their future. This often leads to poor psychological well-being~     and reduced health-related quality of life (HRQoL) of the family. Support for Empowerment~     has been proven to be an effective method to improve prognosis of asthma, heart failure,~     osteoarthritis.and diabetes. However empowering interventions have not been studied in~     dementia. Therefore, the investigators aim was to examine, in an objective-oriented group~     intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia~     patients and their spousal caregivers as well as on the sense of competence and~     psychological well-being of caregivers.~      Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be~     recruited from memory clinics or day centers and randomized into two arms: 90 patients for~     group-based ESP sessions including topics selected by the participants and the use of the by~     us for us guides, 90 patients will serve as controls in usual community care. Sessions may~     include topics on dementia, active lifestyle and prevention for cognitive decline, spousal~     relationship, future planning and emotional well-being. The patients and spouses will have~     their separate group sessions (ten participants per group) once a week for eight weeks.~   "
50834|NCT02391753|"~     The aim of the study was the define changes LAM morphology, biometric measurements of the~     LAM and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery~     was evaluated. We also sought to define the optimal time for evaluation of pelvic floor~     after childbirth~   "
50835|NCT02391740|"~     Describe the expectations of therapeutic education for patients in management of cancer~     pain.~   "
50836|NCT02391727|"~     A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor~     on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by~     inhibiting the growth of cancer cells thereby prolonging the life of patients who have~     received it. SYN004 is a closely related monoclonal antibody also binds to the EGF receptor~     in the same way. SYN004 might also inhibit cancer cells and prolong life but has been~     engineered to avoid some of the hypersensitivity reactions known to provoked by cetuximab.~   "
50837|NCT02391714|"~     The purpose of this study is to determine whether Nitrous Oxide is effective in achieving~     pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).~   "
50838|NCT02391701|"~     BACKGROUND:~      The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and~     Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of~     non-fatal acute myocardial infarction. Possible mechanisms of this association may be~     related with a lower concentration of markers of inflammation and with reduced~     triglycerides, insulin, insulin resistance, and systolic blood pressure.~      Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of~     inflammation, and iii) anthropometric indices in a population-based study~      METHODS:~      This is a non-pharmacological clinical trial study which is performed on a family-oriented~     basis. 250 families (~ 750 children and adults, older than 3 years) were selected to~     participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control~     (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3~     months in 120-minute diet sessions and freely receive AD food, characterized by a high~     intake of vegetables, cheese, olive oil, mussels and by wine consumption during meals.~     Control group subjects do not participate in any regular diet activity during this period~     and did not receive additional food. Exclusion criteria are alcoholism, lipid treatment,~     dementia, and terminal disease.~      Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food~     frequency questionnaire, physical activity, blood pressure, metabolic function (fasting~     blood glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers~     (c-reactive protein, interleukin 6 and tumor necrosis factor-alpha) are measured at~     baseline, 3 and 6 months. Mixed effect models will be performed to assess the significance~     of changes in the cardiometabolic parameters.~      The primary end point is the change in lipid profile compared with baseline and the control~     group arm at the end of Month 6. The secondary exploratory end points were change in~     anthropometric indices and inflammation markers at Month 6.~   "
50839|NCT02391688|"~     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes~     and transporters in vivo. It consists of the administration of probe substances metabolised~     by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by~     the determination of a metabolic ratio or the evaluation of the plasmatic or urinary~     concentrations of the probe substances. The administration of a cocktail containing several~     probe substances allows the simultaneous evaluation of the activity of several cytochromes~     and P-gp in a single test.~      When a cocktail approach is used it is important to make sure that no drug-drug interactions~     occur between the probes within the cocktail. The validation of the lack of interactions,~     which is the aim of the study, consists of demonstrating that there is no difference in the~     pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as~     part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen,~     omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of~     CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.~      Probe and metabolite concentrations will be measured in capillary blood using a dried blood~     spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to~     ensure the precision of capillary blood collection.~   "
50854|NCT02391480|"~     This is a Phase 1, first-in-human, dose escalation study of ABBV-075 in participants with~     advanced cancer to determine the maximum tolerated dose and the recommended Phase 2 dose of~     ABBV-075. In addition the study will evaluate the safety. tolerability and the~     pharmacokinetics of ABBV-075 and will evaluate differing schedules of administration.~   "
51155|NCT02387541|"~     To investigate the effects of total knee replacement is harmful to Postoperative cognitive~     dysfunction~   "
50840|NCT02391675|"~     The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at~     characterizing factors that influence the development and severity of acute appendicitis. In~     a cohort of 300 patients and 300 controls, environmental factors as well as genetic make-up~     of the innate immune system, focusing mainly on pattern recognition, will be analyzed in~     order to gain insight in their relative importance in the pathology of appendicitis.~     Furthermore, populations of micro-organisms present in the gut of patients will be~     characterized, and the interaction between relevant micro-organisms and the innate immune~     system will be analyzed.~   "
50841|NCT02391662|"~     Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer~     is 1:3. Although many clinical trials include elderly patients, no results for this subgroup~     of patients are available. Since there is no specific recommendations for treatment of~     elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment~     of choice for these patients.~      Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and~     targeted agents to gemcitabine has almost invariably provided no significant survival~     improvement.~      Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic~     cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in~     overall survival, but due to in this clinical trial was included patients between 27 and 88~     years, it is considered necessary to conduct a specific study for patients over 70 years.~      The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel~     associated with gemcitabine can be extended to elderly patients with pancreatic cancer.~   "
50842|NCT02391649|"~     This proposed randomized controlled trial will test the effectiveness of a problem-solving~     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum~     disorders. A repeated-measures, three-group design will be used to evaluate and compare the~     effects between two treatment groups(PSBBP and psycho-education group) and routine~     outpatient service and family support (control group) for 129 randomly selected family~     caregivers of outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.~   "
50843|NCT02391636|"~     Double blinded randomized controlled study~   "
50844|NCT02391623|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple oral doses of PF-06427878 in healthy adult subjects.~   "
50845|NCT02391610|"~     The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative~     and interactive effects of maternal environmental exposures on birth outcomes and children's~     development. The C-ABCS recruited pregnant women from six major cities of Anhui province,~     China, between November 2008 and October 2010. A range of data (including demographic,~     obstetric, occupational, nutritional and psychosocial factors) were collected by both~     interviews and laboratory tests. In each trimester, women's blood samples were drawn, and~     pregnancy complications were abstracted from physician's medical records. By the end of~     2011, birth outcomes/birth defects were observed/identified by clinicians within 12 months~     after the delivery of 11 421 singleton live births of six cities and those outcomes among~     the remaining 2033 live births are still being observed. In addition, 4668 children from~     Ma'anshan city will be further followed up during the pre-school period till they reach~     adolescence to obtain the data on familial environmental exposures as well as children's~     physical, psychological, behavioural and sexual development. The interview data and~     information on laboratory examinations are available on request from archives in the Anhui~     Provincial Key Laboratory of Population Health & Aristogenics.~   "
50846|NCT02391584|"~     Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube~     dilation.~   "
50847|NCT02391571|"~     This single-center study is a randomized, double-blind, active-controlled, multiple-dose,~     parallel group study to evaluate the potential withdrawal effects, safety and tolerability,~     and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact~     Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent~     subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase~     (including a methadone stabilization period, a placebo administration period, a treatment~     administration period and a safety/washout period), and a Follow-up Phase.~   "
50848|NCT02391558|"~     Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace~     fluorescein angiography.~   "
50849|NCT02391545|"~     A Two-arm, Phase 1b/2 Study of IPI-145 Administered in Combination with Rituximab or~     Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.~   "
50850|NCT02391532|"~     The aim of this study is to investigate the effect of daily intake of the probiotic~     Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living~     in nursery homes.~   "
50851|NCT02391519|"~     Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high~     altitude and may contribute to the observed 3-fold increase in intrauterine growth~     restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial,~     cord blood, and placental tissue samples from women at high altitude (Summit County) and low~     altitude (Denver) in Colorado in order to determine if residence at altitude during~     pregnancy changes the vasoreactivity of myometrial arteries (MA). If altered MA~     vasoreactivity is found, further studies may be able to link these changes to the increased~     rates of PreE and IUGR at altitude and contribute to the understanding of these two~     disorders.~   "
50852|NCT02391506|"~     This study will evaluate whether Cartiva is an effective treatment for individuals with~     osteoarthritis of the CMC joint in the hand.~   "
50853|NCT02391493|"~     For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping~     studies have shown that different languages may be localized, at least partially, in~     distinct microanatomical systems located within the same gross anatomical areas.~      The present investigation involves both types of healthy bilinguals with carefully~     controlled proficiency levels, as well as bilingual patients suffering from low-grade~     glioma.~      Functional magnetic resonance imaging data will be collected while the participants perform~     a picture naming task in blocked conditions for both languages (either English or French) or~     in switch condition (English and French). A stimulation mapping study will be conducted in~     the patients during awake surgery with the same tasks.~   "
58145|NCT02296073|"~     To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to~     the pediatric intensive care unit after surgery.~   "
50855|NCT02391467|"~     Non invasive methods are the only available methods to stage liver fibrosis during~     pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision~     of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore,~     this method is sometimes used in pregnant women with recent diagnosis of chronic viral~     hepatitis infection, whereas its validity in pregnant women has never been studied. This~     lack of data justifies our study.~   "
50856|NCT02391454|"~     Rationale: Cancer treatment is increasingly successful, resulting in a rising number of~     cancer survivors. A substantial number of survivors may experience long-term and late side~     effects from their cancer treatment. In addition, evidence is accumulating that an active~     lifestyle positively influences cancer treatment outcome and changes the recurrence rates of~     the disease. Therefore, physical activity (PA) programs are urgently needed and should be~     incorporated in current treatment regimens. It is noted though that cancer patients and~     survivors experience difficulties in remaining physically active. A 'smartphone application'~     (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by~     Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and~     well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring~     PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this~     study the investigators aim to determine if the RunKeeper app use improves PA by~     self-monitoring and empowering PA during or after cancer treatment in comparison with usual~     care in a 12-week follow-up.~      Objective: The primary objective is to identify an improvement in PA as measured by the PASE~     questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during~     or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist~     in stimulating and improving PA behavior. Secondary objectives are to explore the usability~     of the RunKeeper app.~      Study design: The present study is a single-centre prospective two-armed randomized~     controlled feasibility study.~      Study population: Adult patients diagnosed with cancer currently being treated or under~     surveillance at the department of Medical Oncology at the UMCG.~      Intervention: Patients who give informed consent will be randomized in one of the two study~     arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15).~     Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and~     requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to~     self-monitor PA.~      Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the~     RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical~     Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the~     RunKeeper app might assist in stimulating and improving PA behavior.~   "
50857|NCT02391441|"~     The investigators will evaluate ventricular reversed remodelling after double lung~     transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with~     cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control~     patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.~   "
50858|NCT02391428|"~     Attention deficit hyperactivity disorder (ADHD) is a major problem in children and~     adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated~     fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with~     important physiologically active functions.~      Aim: Study the relationship between omega3 blood values and ADHD clinical status.~      Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a~     child psychiatrist. In addition the investigators will recruit a control group of 30~     children without ADHD and related neuropsychiatric syndromes. Blood will be taken from all~     children.~      The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6~     months, all children will undergo clinical examination and blood tests will be taken for~     omega3 index analysis. Blind frozen samples of isolated red blood cell (RBC) will be~     analyzed according to the omega3 index methodology.~   "
50859|NCT02391415|"~     Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease~     C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated~     and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons~     at risk in non-endemic areas. The new vaccine should be at least as potent as the current~     strain and should be safer than BCG.~      The preceding phase-IIa trial was the first investigation of VPM1002 in newborn infants in a~     high burden setting in South Africa. The vaccination of HIV-unexposed infants with VPM1002~     indicated again safety, tolerability and immunogenicity sufficient to proceed in HIV-exposed~     infants.~      The current study is a multiple site trial in South Africa to evaluate safety and~     immunogenicity in HIV-unexposed and -exposed newborn infants.~   "
50860|NCT02391402|"~     The primary objective of this study is to evaluate the efficacy of Cognitively Augmented~     Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid~     mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's~     specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with~     mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with~     mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning,~     and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for~     Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized~     treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health~     Administration (VHA) treatment settings.~   "
50861|NCT02391389|"~     Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for~     preterm infants. Initiation of breathing before cord clamping is also thought to be~     beneficial. Since some preterm infants do not breathe well on their own immediately after~     birth, assisting ventilation during delayed cord clamping might have additional benefit~     beyond DCC alone. VentFirst Pilot will assess feasibility and safety of assisting~     ventilation of preterm infants during 90 seconds of DCC which is essential before proceeding~     to a randomized clinical trial.~   "
50862|NCT02391376|"~     The purpose of this study is to compare the effects generated by the application of three~     different packs on the flexibility of the lower back of sedentary students. Method: Three~     sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed~     pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and~     erythema were registered every 5 minutes. Schober test was performed before first session~     and after the third session.~   "
50863|NCT02391363|"~     The purpose of this research study is to see how helpful two different interventions offered~     through the Calmer Life program are in reducing worry and improving mood. The investigators~     also want to understand how a program like Calmer Life can be offered in underserved~     communities.~   "
50864|NCT02391350|"~     Low back pain and sciatica is a common condition resulting in high costs and disability for~     society and affected individuals. Presently there is a lack of evidence for what treatments~     may help this condition early in the course of care. Improved early management could reduce~     risks for persistent disability and high costs. The goal of this project is to examine the~     clinical outcomes and costs associated with adding a physical therapy program to early~     management of patients with low back pain and sciatica within primary care.~   "
58146|NCT02296060|"~     To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT~   "
50865|NCT02391337|"~     Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for~     patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in~     death. The number of patients with this condition are expected to double in the next 20~     years. Medications to control heart-rate are used in the majority of patients, although the~     choice of agent is often guided by local preference rather than evidence from controlled~     trials. Despite the fact that patients with atrial fibrillation have high rates of other~     cardiac conditions such as heart failure, clinicians have insufficient evidence to~     personalise the use of different therapies. This feasibility study will allow us to develop~     a range of methods that can characterise patients according to the pumping and relaxing~     function of the heart, the burden of symptoms and to identify new blood markers. In this~     way, the investigators hope to improve clinical practice guidelines, allowing doctors to~     prescribe appropriate treatments for the right patients.~      The research will be focused around a randomised trial of two medication strategies,~     providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used~     drugs in patients with atrial fibrillation). It will also allow us to identify the best way~     to record patient-reported quality of life and develop robust techniques to determine heart~     function using non-invasive imaging, facilitating the conduct of a large-scale clinical~     trial. The key objectives of the research programme are to define the optimal medications~     for patients with atrial fibrillation and identify the most valid, reproducible and~     cost-effective methods to examine patients. The ultimate aim of the project is to improve~     clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service~     and the global community.~   "
50866|NCT02391324|"~     Robot assisted gait training is seen as a promising intervention for improving the walking~     abilities of children with cerebral palsy, but research to support its effectiveness~     compared to best practice physical therapy is lacking. This research consists of a~     randomized controlled trial (RCT) and a qualitative descriptive study that is linked with~     the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat®~     robotic device (LOK), 2) a functional physical therapy program (fPT) that includes~     activities to enhance balance/co-ordination/endurance and advanced motor skills conducted~     over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program,~     and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with~     CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute~     sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to~     compare the four groups with respect to walking-related motor skills as measured by the~     Gross Motor Function Measure. The secondary objectives are to compare each intervention's~     impact on walking abilities, individualized goals, fitness, balance, physical activity~     levels, child's belief in ability to do physical activity, participation and quality of~     life. The investigators will also evaluate the extent of carryover or progress 3 months~     after the intervention. The qualitative part of the study will consist of interviews of~     children and parents after they have finished the study intervention. The information from~     the interviews will assist us with interpretation of the outcome results (areas of impact~     and amount of change) from the RCT. In particular, the interviews will 1) provide insight~     into their experiences with the trial interventions, 2) identify the mobility-related~     outcomes that are important to families and the factors that influence their preferences,~     and 3) explain the family values, experiences and contextual factors that influenced~     participation in the study. This research will provide information needed to allow~     clinicians and families to make informed choices about Lokomat therapy and physical therapy~     options in relation to their child's functional goals and abilities.~   "
50867|NCT02391311|"~     The goal of this study is to conduct a small, self-contained project to test the hypothesis~     that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The~     investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours~     in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30)~     and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis~     1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the~     SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate~     generalization to secondary neurocognitive domains compared to the sham tDCS condition.~   "
50868|NCT02391298|"~     The aim of this study is to examine whether meditation delivered by the internet improves~     mood and attention as well as increases levels of dopamine in individuals who have been~     diagnosed with Multiple Sclerosis.~   "
50869|NCT02391285|"~     To assess the potential clinical utility of measuring pelvic floor muscle tone after~     childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting~     first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and~     imaging assessment routinely offered women at this clinic, the investigators will measure~     their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer.~     The investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset~     of 10 women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of~     the pelvic hiatus. The investigators will then determine the predictive capacity of vaginal~     elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR~     scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry~     can prove an objective and accurate frontline assessment tool for the management of PFMD~     following childbirth. Our observations will generate vital data for powering and designing a~     large clinical trial evaluating the potential use of the vaginal elastometer as a first line~     assessment tool of PFMD in the postnatal period. Data will also inform the design of a~     personalised model for predicting and managing pelvic floor muscle damage during childbirth.~   "
50870|NCT02391272|"~     The project was undertaking by Qilu Hospital of Shandong University and other well-known~     hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in~     pregnancy.~   "
50871|NCT02391259|"~     This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising~     single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing~     cohorts~   "
50872|NCT02391246|"~     Gliomas are the most common malignant primary central nervous system (CNS) tumours. When~     high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional~     sequences is required.The Positron Emission Tomography (PET) radiotracer~     [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes~     seen on MRI which can be a reflection of pseudoprogression, radiation necrosis, or~     recurrence.~   "
50873|NCT02391233|"~     The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the~     effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention~     (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other~     sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as~     Black) women drug users in probation sites in New York City (NYC), compared to streamlined~     HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post~     intervention. The primary outcomes will be to reduce cumulative incidence of biologically~     confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex~     acts.~   "
50874|NCT02391220|"~     This study evaluates the effect of a symbiotic fermented milk on health-related quality of~     life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant~     IBS.~   "
50929|NCT02390505|"~     Vitamin C with its antioxidant role has many indications. The objective of this study is to~     demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of~     complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the~     upper limb.~   "
50875|NCT02391207|"~     Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the~     caval confluence (CC). As alternative, HV reconstruction has been proposed. The present~     study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by~     intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal~     liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large~     majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction:~     this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically~     provides an adequate local control.~   "
50876|NCT02391194|"~     This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent~     breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.~   "
50877|NCT02391181|"~     A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection~     Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The~     Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance~     Availability in the Blood Circuit.~   "
50878|NCT02391168|"~     A multi-center, prospective cohort study on the natural history of fatty liver disease in~     China~   "
50879|NCT02391155|"~     In this study, the investigators aimed to evaluate to the efficacy of the needle type used~     in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.~   "
50880|NCT02391142|"~     The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on~     Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac~     structure, systolic function, electrical activities and concentration of B - type~     natriuretic peptide precursor in patients with Chronic Heart Failure.~   "
50881|NCT02391129|"~     The purpose of this study was to compare the clinical (range of motion, weight bearing,~     quality of life) and radiographic outcome (boney consolidation) between open reduction and~     internal fixation using locking compression plates with revision prosthesis using a~     non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C~     periprosthetic fracture after primary total hip replacement.~   "
50882|NCT02391116|"~     To assess the potential efficacy (in terms of objective response) of single agent copanlisib~     in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the~     relationship between efficacy and a potentially predictive biomarker~   "
50883|NCT02391103|"~     The purposes of this study are 1) to determine whether neuromuscular electrical stimulation~     (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the~     time variation of MLT and strength from preoperative day to hospital discharge.~   "
50884|NCT02391090|"~     Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic~     chamber simulating 2800m above sea level. Study participants will be blinded to the~     treatment given and divided into a hypoxic and a sham group (about 360m above sea level).~      Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be~     measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before~     and after the study. Secondary endpoints include blood parameters, lung function testing and~     questionnaires.~   "
50885|NCT02391077|"~     There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space,~     therefore we would like to investigate possible techniques to reduce this potential.~   "
50886|NCT02391064|"~     Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly~     information processing speed (IPS) which also influences with other cognitive functions such~     as attention, working memory and executive functions. The investigators validated a~     computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect~     disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for~     multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT),~     a test of the IPS, and two measures of episodic memory. On the same principle, the~     investigators propose to validate a short computerized battery to improve the feasibility~     (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized~     test of visual episodic memory.~      Purpose: to establish the screening value of a brief computerized cognitive assessment~     (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized~     episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as~     compared to a reference battery (MACFIMS).~   "
50887|NCT02391051|"~     This trial examines the feasibility and toxicity of focal brachytherapy in patients with~     low-risk prostate cancer.~   "
50888|NCT02391038|"~     The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian~     patients with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent~     Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C~     (GCC).~   "
50889|NCT02391025|"~     This is a single center cross-sectional imaging study investigating the use of gallium-68~     citrate PET in patients with metastatic castration-resistant prostate cancer who are~     planning to undergo a metastatic tumor biopsy on protocol CC# 125519.~      The study population will consist of patients with metastatic castration-resistant prostate~     cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol CC# 125519,~     with evidence of resistance to androgen signaling inhibition.~      The study will involve gallium-68 PET scan obtained at single time point, followed by~     radiographically-guided metastatic tumor biopsy within 14 days of PET scan.~   "
50890|NCT02391012|"~     Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy~     intestine as a probiotic preparation. The feces of a healthy individual is fluidized and~     than inserted into the intestinal tract of a sick individual, assuming that the healthy~     flora will colonize and cure the intestine. There are reports of the efficacy of this~     treatment for inflammatory bowel disease but currently the numbers are small.~      aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients .~     Methods: The patients will undergo full colonoscopy, the stool preparation will be infused~     through the colonoscope during withdrawal of the instrument.~   "
50931|NCT02390479|"~     The primary objective of this case-control intervention study to explore the effectiveness~     of non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of~     sclerostin in patients with chronic periodontitis (CP) so as to get a more detailed insight~     into its diagnostic and prognostic potential as a biomarker of periodontal disease.~   "
50891|NCT02390999|"~     3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic~     hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest~     patients. The investigators are challenged in our attempt to predict outcome of these~     patients by both low body temperature in itself and the sedative and relaxing drugs used to~     keep the patient in a coma.~      This study is a substudy in a large international multicenter randomized trial that~     investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays~     standard of 24 hours.~      In this substudy the investigators will approach early prediction of neurological outcome~     using a combination of new examinations backed up by well established ones to engage this~     challenge from different angles and find a battery of combined examinations, that together~     will enable us to accurately predict outcome at an earlier stage.~      Our examinations have been chosen from the three fields of neurophysiology, biochemistry and~     neurology and consist of electroencephalography (EEG), somatosensory evoked potentials~     (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their~     prognostic reliability.~   "
50892|NCT02390986|"~     The purpose of this clinical trial is to evaluate the long term safety and efficacy of~     LON002.~   "
50893|NCT02390973|"~     Bariatric surgery procedures induce weight loss through restriction and/or malabsorption.~     The mechanisms underlying type 2 diabetes remission and others metabolic improvements after~     Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with~     duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a~     longitudinal study with the overall objective of measuring the long-term impact of these~     three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in~     patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric~     procedures generate hitherto unrecognized effects on many disease-related outcomes, which~     greatly contributes to their beneficial impact in diabetic patients. The investigators~     propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the~     metabolic recovery and quality of life in groups of diabetic patients treated with insulin,~     hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on~     renal and cardiovascular functions in subgroup of patients with these conditions; 3) to~     compare metabolic impact of surgeries to those of best medical care for diabetes in a~     non-surgical control group. For most severely obese patients, lifestyle interventions,~     perhaps effective in inducing short-lived weight losses, are ineffective for long-term~     weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity~     surgeries calls for a better understanding of the underlying mechanisms. This is especially~     true and urgent when considering that knowledge on the relative impact of each procedure~     (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of~     the procedures will allow stronger scientific rationale for selecting the right surgery for~     the right patient and improve care for the severely obese individual.~   "
50894|NCT02390960|"~     This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in~     men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver~     100 mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and~     glans. There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site~     4-Week Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the~     SST-6006/Placebo Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary~     outcomes will be be evaluated at Weeks 7 and 8 of the study~   "
50895|NCT02390947|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical~     tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found~     in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On~     the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies.~      The purpose of this study is to determine whether Famitinib can improve Overall Survival~     (OS) compared with placebo in total 540 patients with advanced colorectal cancer who have~     failed in previously received at least two lines of standard chemotherapy.~   "
50896|NCT02390934|"~     The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in~     treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on~     the results of the phase III trial, the protocol using an injection of Radium-223 activity~     of 50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this~     study will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e.~     at 3 months after the first injection. If disease progression at that time is excluded,~     patients will be treated with 3 further injections for a total of 6 administrations of~     Radium-223. The principal response criterion at 3 and 6 months will be the metabolic~     response on FDG PET/CT, but other imaging techniques will also be performed: axial skeleton~     MRI, 99mTc-HMDP bone scan and FNa PET/CT. Axial skeleton MRI is the reference for soft~     tissue study. 99mTc- HMDP bone scan is the most used and available routine tool to detect~     bone metastases in cancer patients, but its sensitivity in patients with bone metastases~     from thyroid cancer is low, because most lesions are lytic [23]. 18FNa PET/CT shows higher~     sensitivity than 99mTc-HMDP bone scan to detect bone lesions in cancer patients and is able~     to detect micrometastases that are not seen on bone scan [24] [25]. Preliminary results show~     some interest of using this tracer to evaluate the sclerotic component of bone metastases~     from thyroid cancer [26]. Furthermore preliminary data show that FNa PET/CT can be useful to~     quantify response to Radium-223 in prostate cancer. In only five patients evaluated by FNa~     PET/CT at baseline, 6 weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative~     analysis by SUV max showed a relationship between PSA and SUV max level decrease in 3~     patients (-44%, -31%, -27% vs -52%, -75, and -49% respectively) [27].~      Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are~     frequently submitted to local treatment modalities, and this may induce fibrosis and~     recalcification. Therefore, already treated metastases and not treated metastases will be~     studied separately as two separate subgroups of target lesions.~   "
50897|NCT02390921|"~     Bariatric surgery is the most effective long-term treatment of morbid obesity treatment, so~     you can maintain weight loss enduringly with improvement or resolution of comorbidity and~     mortality reduction. All bariatric surgery techniques in postoperative induce a significant~     reduction in food intake and / or absorption of nutrients and therefore may be associated~     with a risk of nutritional deficiency, which increases over the years after surgery. One of~     the nutrients whose absorption is affected significantly is iron, women of childbearing age~     segment most vulnerable being. A significant percentage of these women require oral~     supplementation with high doses of iron and often parenteral treatment is needed for~     digestive intolerance or therapeutic failure.~      Hypothesis: The liposome orally administered iron could represent a therapeutic alternative~     in women of childbearing age, previously undergone bariatric surgery that currently require~     parenteral iron therapy.~      Objectives: To evaluate the tolerability and efficacy of oral iron liposome female patients~     previously undergone bariatric surgery that currently require parenteral replacement~     therapy, as well as the impact on quality of life.~      Methods: a single center, open, prospective, interventional, in 40 women of childbearing~     age, previously undergone bariatric surgery, which currently require intravenous iron~     therapy chronically. Subjects will be divided into 2 parallel groups: 20 cases and 20~     controls matched for age, level of Hb, year after surgery and percentage of weight lost.~      Relevance: This study will allow us to identify an alternative treatment with oral iron in~     the case of patients with severe iron deficiency after bariatric surgery, which currently~     require parenteral iron therapy due to intolerance to current oral products or therapeutic~     failure. At the same time it could help reduce healthcare costs and improve the quality of~     life of these patients, who will not have to enter periodically in solitary day hospital for~     administration of parenteral iron.~   "
50930|NCT02390492|"~     This 2-period, open-label, nonrandomized study will be conducted to determine the absolute~     bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its~     metabolite(s). Healthy male participants will receive a single 200-mg oral dose of~     ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of~     [14C]-ipatasertib. After a 4-day observation period and 10-day washout, participants will~     receive a single 200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data~     collection for an additional 7 to 14 days until discharge criteria are met.~   "
50898|NCT02390908|"~     Alcohol use is increasingly recognized as a key factor in morbidity and mortality among~     HIV-positive individuals and represents an important public health concern, given its~     associations with medication non-adherence, increases in viral load, poor immunologic~     outcomes (lower CD4 counts), drug resistance, lower health care utilization, comorbidities~     (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV~     medications has a double public health benefit, both in terms of slowing disease progression~     and improving health outcomes among HIV-positive individuals and in helping to curb the~     sexual transmission of HIV. The objective of this study is to implement a multisite~     comparative effectiveness trial in real-world clinical settings with three intensities of~     treatment to test the clinical and cost effectiveness of an efficacious, theory-based~     behavioral intervention (PLUS) in improving ART-adherence and alcohol-related outcomes among~     HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is~     being conducted in collaboration between the Center for HIV Educational Studies and Training~     (CHEST) at Hunter College, CUNY and the Spencer Cox Center for Health at the Institute for~     Advanced Medicine, Mount Sinai Health System.~   "
50899|NCT02390895|"~     The purpose of this study is to determine the feasibility of prenatal minimally-invasive~     fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under~     amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with~     one patch or the suture of the skin edges by stitch~   "
50900|NCT02390882|"~     The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412~     and HIP1402 in patients with Benign Prostatic Hyperplasia~   "
50901|NCT02390869|"~     A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of~     Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after induction's~     chemoimmunotherapy with Rituximab-Bendamustine for relapsed/refractory FL patients not~     eligible for autologous transplantation (ASCT).~   "
50902|NCT02390856|"~     Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed~     using a variety of fixation techniques. The most common method is fixed angle volar plate~     application. The investigators plan to compare the outcomes of fixed angle volar plating~     with a novel FDA approved intramedullary fixation device, Conventus DRS.~   "
50903|NCT02390843|"~     This is a Phase I trial with new experimental drugs such as simvastatin in combination with~     topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors~     that have come back or that have not responded to standard therapy. This study will define~     toxicity of high dose simvastatin in combination with topotecan and cyclophosphamide and~     evaluate for cholesterol levels and IL6/STAT3 pathway changes as biomarkers of patient~     response.~   "
50904|NCT02390830|"~     Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS)~     Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance~     disorders and frequency of falls.~      Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups~     received 20 treatment sessions. Participants in the intervention group received treatment~     aimed at improving control of the position and movement of the centre of mass and body~     segments. Participants in the control group received treatments to reduce limitations at~     activity and body function level.~      Group allocation was done by an independent clinician by a randomization list made before~     the beginning of the study. Group allocation was kept concealed throughout the study and~     participants were not aware of group assignment.~      Data was analyzed according to a preplanned protocol by using an intention to treat~     approach.~   "
50905|NCT02390817|"~     The study will be performed to evaluate motor response and awareness with using sugammadex~     during wakeup procedure in spine surgery. The investigator's goal is to investigate the~     effect of sugammadex on the state of consciousness and motor-somatosensorial evoked~     potentials.~   "
50906|NCT02390804|"~     The objective of this study is to compare postoperative pain between single-port access~     total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and~     conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A~     prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign~     gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients~     and postoperative pain and operative outcomes were examined.~   "
50907|NCT02390791|"~     Cluster randomized controlled trial to evaluate the general effectiveness of intervention~     compared to control on medication continuity as measured by prescriptions written and other~     more proximal outcomes during the first six months of treatment.~   "
50908|NCT02390778|"~     The objectives of the study were: To (1) describe the epidemiology of emotional distress~     experienced by Ugandan violence researchers; to (2) assess the effectiveness of group~     debriefings in mitigating secondary distress; to (3) assess risk and protective factors.~     Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS,~     NCT01678846) to interview children and adults who experienced violence. Recruited~     participants were randomly assigned to group debriefings (intervention) or film viewing~     (control). The primary outcome was change in levels of emotional distress.~   "
50909|NCT02390765|"~     Background:~      - Studies show that many factors affect children s eating behavior and health. These include~     sleep, mood, thinking skills, and genetics. Studying children over time may identify~     children at higher risk for eating-related health concerns.~      Objective:~      - To understand how genes and environment influence eating behavior and health over time.~      Eligibility:~      - Children ages 8 17 in good general health.~      Design:~        -  Screening visit 1: Medical history, physical exam, body measurements, and questions.~        -  14 days: Participants will wear a wrist monitor and answer smartphone prompts about~          eating and mood. They may give a stool sample.~        -  Screening visit 2:~        -  Body measurements.~        -  Saliva, urine, and blood samples.~        -  Heart tests.~        -  Meals provided (after fasting overnight).~        -  Questionnaires and interview.~        -  Behavior, thinking, and exercise tests.~        -  X-ray of left wrist and full body.<TAB>~        -  Some parents may have medical history, physical exam, and questions at screening~          visits. They may answer questions at the yearly visits.~        -  Participants will have up to 6 yearly visits. They will give a urine sample and body~          measurements, and repeat the X-rays. They will have questions and behavior and thinking~          tasks. They may give stool samples. Visits will range from 3 to 8 hours.~        -  Participants may choose to participate in other studies:~        -  Stress and Hormones, 1 visit: While resting, participants will give saliva samples and~          have their heart monitored. Then they will do math. They will repeat the resting part,~          then do a computer task.~        -  Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on~          their head then answer questions. Once, they will have an MRI, lying still in a scanner~          with a coil on their head.~        -  Sleep, 2 visits: Participants will have food provided, answer questions and do tasks.~      Participants will be compensated for the time and inconvenience involved with completing~     study procedures.~   "
50932|NCT02390466|"~     The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled~     HIV patients receiving standard of care antiretroviral treatment.~   "
50910|NCT02390752|"~     Background:~      - Some people with cancer have solid tumors. Others have refractory leukemia. This doesn t~     go away after treatment. Researchers want to see if a drug called PLX3397 can shrink tumors~     or stop them from growing.~      Objectives:~      - To find the highest safe dose and side effects of PLX3397. To see if it helps treat~     certain types of cancer.~      Eligibility:~        -  People ages 3 22 with a solid tumor or leukemia that has returned or not responded to~          cancer therapies.~        -  For Phase II, people ages 3 31 with a Neurofibromatosis Type 1 (NF1) Associated~          Plexiform Neurofibroma (PN) that cannot be removed with surgery.~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart tests~        -  Scans or other tests of the tumor~        -  Participants will take PLX3397 as a capsule once daily for a 28-day cycle. They can do~          this for up to 2 years.~        -  During the study, participants will have many tests and procedures. They include~          repeats of the screening tests. Participants will keep a diary of symptoms.~        -  Participants with solid tumors will have scans or x-rays.~        -  Participants with NF1 PN will have MRI scans.~        -  Participants with leukemia will have blood tests. They may have a bone marrow sample~          taken.~        -  Some participants may have a biopsy.~        -  When finished taking PLX3397, participants will have follow-up visits. They will repeat~          the screening tests and note side effects.~        -  Phase II will follow the same procedures as Phase I above, but participants will also~          fill out questionnaires about their pain and quality of life.~   "
50911|NCT02390739|"~     Background~      The NCI Surgery Branch has developed an experimental therapy for treating patient with~     metastatic thyroid cancer that involves taking white blood cells from the patient, growing~     them in the laboratory in large numbers, genetically modifying these specific cells with a~     type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to~     the patient. This type of therapy is called gene transfer. In this protocol, we are~     modifying the patient s white blood cells with a retrovirus that has the gene for~     anti-thyroglobulin incorporated in the retrovirus.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the thyroglobulin molecule on their surface can cause~     thyroid tumors to shrink and to see if this treatment is safe.~      Eligibility:~      <TAB>Adults 18 and older with thyroid cancer that has the thyroglobulin molecule on tumor~     surfaces~      Design:~      <TAB>Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~     undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~     needed~      <TAB>Leukapheresis: If the patients meet all of the requirements for the study they will~     undergo leukapheresis to obtain white blood cells to make the anti- thyroglobulin cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      <TAB>Treatment: Once their cells have grown, the patients will be admitted to the hospital~     for the conditioning chemotherapy, the anti-thyroglobulin cells and aldesleukin. They will~     stay in the hospital for about 4 weeks for the treatment.~      Follow up:~      Patients will return to the clinic for a physical exam, review of side effects, lab tests,~     and scans about every 1-3 months for the first year, and then every 6 months to 1 year as~     long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
50912|NCT02390726|"~     The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant~     (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the~     expanding choices of medication for UC, physicians and patients are still in search of~     highly effective and safe medications with minimal side effects. FMT has been approved for~     the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT~     has been proven to be an effective and safe alternative therapy with zero reported serious~     adverse events from patients that have had this treatment.~      The providers that are conducting this study hypothesize that delivering microbes from a~     healthy human gut can help treat the damages caused by UC. This is done by transplanting~     fecal material, which contains a highly complex and dense community of healthy microbes,~     including bacteria, fungi and viruses. This collection of microbes is referred to as a~     microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.~   "
50913|NCT02390713|"~     This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during~     and after major hepatectomy (48h) to protect the liver during the initial phases of liver~     regeneration. Morphological features of MID-AVRTM allow its intra corporeal opening and~     percutaneously removal after an balloon inflation with 5 ml of physiological serum.~     MID-AVRTM had been developed in pig where it had proved its efficiency to improve liver~     function after 75% hepatectomy and its capacity to be removed percutaneously. Aim of this~     feasibility study (Phase I/II) is to prove in series of 3 evaluable patients (Phase A) then~     6 evaluable patients (Phase B) that MID-AVRTM could be used in human without deleterious~     consequence. In phase A, MID-AVRTM is dispose around the portal vein before and during a~     major hepatectomy performed on healthy liver and removed before abdominal closure. If phase~     A results confirmed that MID-AVRTM well modulates portal pressure and is easily opened and~     removed by acute inflation, the phase B will be started. In phase B, MID-AVRTM will be~     dispose around the portal vein before major hepatectomy on healthy liver and conserved 48~     hours before to be removed percutaneously at the operating room.~   "
50914|NCT02390700|"~     The purpose of this study is to evaluate the incidence and management of infusion reactions~     with Golimumab intravenous infusion.~   "
50915|NCT02390687|"~     Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory~     response and alter the diversity of periodontal disease. In recent years, various~     host-response modulation therapies have been developed to block the pathways responsible for~     periodontal tissue breakdown.~      There have been significant changes with respect to the effectiveness of, and attitudes~     towards conventional antimicrobial therapy to combat disease. With the threat of widespread~     antibiotic resistance rendering many antibiotics useless against important diseases, there~     is an increased necessity not only to minimise antibiotic use and develop novel~     non-antibiotic-based treatments, but also to raise the profile of disease prevention. One~     approach that has gained interest over recent years is the use of probiotic bacteria for~     oral applications. The rationale for their use in oral health care stems from the increase~     in evidence that supports their claims for benefit for a range of diseases. Lactobacilli~     play an important role in the maintenance of health by stimulating the natural immunity as~     well as by contributing to the balance of the microflora, by interacting with the other~     members of the flora. The application of health promoting bacteria for therapeutic purposes,~     is one of the strongest emerging fields. Time has come to shift the paradigm of the~     treatment from specific bacteria elimination to alteration of the bacterial ecology by using~     probiotics.~      So the purpose of this study is to discover a more promising approach for the treatment of~     chronic periodontitis .~   "
50933|NCT02390453|"~     This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise~     training versus control condition on executive cognitive function in older adults with mild~     cognitive impairment (MCI).~   "
50916|NCT02390674|"~     Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves~     opening a blocked artery with a balloon then inserting a metal scaffold (stent) to hold the~     artery open. During this procedure inflammation can occur causing further damage to the~     heart. The objective of this trial is to determine whether administration of the drug~     ciclosporin prior to PPCI reduces the amount of damage to the heart relative to treatment~     with placebo. The damage to the heart is assessed after 12 weeks by an magnetic resonance~     imaging (MRI) scan. Patients are followed-up after 12 months participation in the study.~      This is a single centre study looking to recruit 68 patients.~   "
50917|NCT02390661|"~     The proposed study is randomised controlled trial where informed and consenting patients who~     have a Mammosite/SAVI device placed, are randomized into two groups: a control group that~     has the device removed in the traditional manner without having a drain placed, and an~     experimental group that will have a penrose drain placed under sterile conditions at the~     time of removal of their device. The drain will be placed in the same site used for the APBI~     device and no additional surgery will be performed. The drain will remain for 2-3 days and~     it will be removed by the patient at home. They will return for their routine follow-up~     appointments and be monitored for development of a seroma with the use of standard~     ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no~     difference in the rate of seroma formation after the APBI device removal if a drain is~     placed.~   "
50918|NCT02390648|"~     Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who~     has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy~     is recruited. The patient who meets the eligibility criteria and provides informed consent~     is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by~     mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the~     subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice~     versa). The primary outcome is the nausea score and vomiting during the first 5 days of each~     chemotherapy cycle when receiving the study drug.~   "
50919|NCT02390635|"~     The goal of this clinical research study is to learn if positron emission tomography/~     computed tomography (PET/CT) and whole body magnetic resonance imaging (MRI) can be used to~     detect extramedullary myeloid leukemia (EML). EML is a type of cancer found outside of the~     bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone~     marrow aspirations.~   "
50920|NCT02390622|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial~     infection. Along with the widely application of antibiotics around perioperative period,~     MRSA infection is increasing by years.Fecal microbial transplantation (FMT),infusion of~     fecal preparation from a healthy donor into the GI tract of a patient is being proposed as a~     novel therapeutic approach to modulate diseases associated with pathological imbalances~     within the resident microbiota, termed dysbiosis.It has been used to treat intestinal~     disease such as inflammatory bowel diseases and Clostridium difficile infection, but no~     reports are available on its role in treating MRSA enteritis yet. vancomycin is the first~     choice to treat MRSA but can also lead to an increase in antibiotic resistant organisms such~     as vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and~     transfer of antibiotic resistance genes among the microbial community. So FMT seems a more~     harmless and reasonable measure to treat similar diseases.~   "
50921|NCT02390609|"~     The purpose of this study is to assess the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of ibrutinib in healthy adults~     following single oral dose administration of suspension and sprinkle formulations under fed~     and fasted conditions compared with capsules under fasted conditions.~   "
50922|NCT02390596|"~     The study is designed to assess the efficacy and safety of anakinra, an interleukin 1~     receptor antagonist, in patients with Kawasaki disease who failed to respond to standard~     treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.~   "
50923|NCT02390583|"~     This is an open label randomized controlled trial, comparing two modes of treatment for~     internet addiction (gaming or gambling online) with sleep disorders associated.~   "
50924|NCT02390570|"~     This study is designed to answer why patient capacity (i.e. patient available abilities~     and resources to enact self-care and access healthcare) is not regularly documented in the~     Electronic Medical Record (EMR) in a way that is useful for clinicians.~      Through the implementation of communication tools designed for patient capacity assessment~     and engagement of stakeholders in a process of user-centered design, the study team~     hypothesizes that the study can help clinicians elicit this information in conversation and~     regularly document it in the medical record for future healthcare discussions.~   "
50925|NCT02390557|"~     No standard way exists to measure the quality of medical care or independent living~     long-term services and supports provided to persons with disabilities. This project will:~     provide a broader picture of how consumers with disabilities define care and care quality;~     measure the value of using consumers' expertise in developing, collecting, and assessing~     quality measures; and use this information to assist One Care providers in improving care~     delivered to their enrollees~   "
50926|NCT02390544|"~     The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children~     undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important~     component of HSCT preparative regimens, but can be associated with significant toxicity. PK~     data is a powerful clinical tool that, when used to develop individualized treatment plans~     for a specific patient, may ultimately increase the likelihood of selecting the right dose~     for the right patient and/or of reducing the number of adverse drug events. The~     investigators' goal is to establish baseline pediatric melphalan PK data. These data may be~     used for patient specific dosing of melphalan in the future to minimize toxicity and improve~     transplant outcomes.~   "
50927|NCT02390531|"~     The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than~     currently used for severe ROP, is effective in this study, and can be tested in future~     larger studies.~   "
50928|NCT02390518|"~     This is a Phase I dose escalation trial. The purpose of this study is to determine the~     maximum tolerated dose of radiation received during stereotactic radiosurgery in patients~     with brain metastases who have never received radiation to the brain before.~   "
58815|NCT02287324|"~     The purpose of the study is to see if manipulation of the neck will change the way people~     who may or may not have neck pain, walk under differing conditions.~   "
50935|NCT02390427|"~     This research study is a way of gaining new knowledge about the combination of Taselisib~     with other drugs in the treatment of metastatic breast cancer. Taselisib is an~     investigational drug which works by blocking a protein called PI3K (phosphoinositide~     3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments~     and information from these studies suggests that this drug may help to prevent or slow the~     growth of cancer cells. The main purpose of this study is to find the appropriate dose of~     Taselisib to be used with other drugs in further clinical studies. This is an open-label,~     3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to~     identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4~     separate arms. (A-D).~   "
50936|NCT02390414|"~     The purpose of this observational study is to compare overall survival in older adults with~     myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic~     stem cell transplant (RIC HSCT) versus those who do not receive HSCT.~   "
50937|NCT02390401|"~     To study if incisional vacuum-assisted closure can decrease the risk of infection in~     cesarean section incisions in the obese compared with standard sterile dressing.~   "
50938|NCT02390388|"~     The aim of this prospective randomized study is to assess the analgesic efficacy and~     duration of Pudendal block compared with Caudal block for pediatric patients undergoing~     hypospadias surgery concerning intraoperative analgesic and also postoperative total~     analgesic consumption within 24 hours.~   "
50939|NCT02390375|"~     The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients~     with primary hypercholesterolemia~   "
50940|NCT02390362|"~     We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than~     MMF in maintaining remission in children with frequent relapsing or steroid dependent~     nephrotic syndrome who have had one relapse while receiving MMF.~      We will conduct a randomized study comparing two Rituximab infusions and continued MMF~     treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).~   "
50941|NCT02390349|"~     This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and~     Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will~     receive Curamin and one group will receive placebo.~   "
50942|NCT02390336|"~     The concept of mobilization with movement, also referred to as a Mulligan mobilization, has~     not been studied in patients with hip osteoarthritis, subsisting questions about the~     possible effects in this population. The aim of this randomized controlled study is to~     compare the immediate effects of Mulligan mobilization with movement technique of pain,~     range of motion and physical function in patients with osteoarthritis of the hip.~   "
50943|NCT02390323|"~     This study is intended to evaluate a monitor that will facilitate ascertainment of an~     effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor~     with a rapid response and easy clinical applicability which can demonstrate effective~     sympathetic block would increase efficiency within the procedure suite and also serve to~     function as an objective endpoint for the evaluation of sympathetic blockade in future~     research.In current clinical practice, the most commonly used monitoring methods are~     clinical observations of sympathetic blockade, skin temperature monitoring, pulse pressure~     monitoring and any combination of these monitoring methods. The skin temperature and pulse~     pressure may increase after sympathetic block. However, changes in the skin temperature and~     pulse pressure often demonstrate an unpredictable or delayed response. Confounding~     variables, such as ambient temperature, coexisting vascular disease, use of other vasoactive~     medications may contribute to inconsistencies in the temperature or pulse pressure~     responses.~      Normal sympathetic activity stimulates muscarinic receptors in the periphery that~     subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and~     other electrolytes. The electrolytes present in the sweat increase the electrical~     conductance while decreasing the electrical resistance at the skin level.~      The real-time changes in skin conductance indices can be monitored at the skin level, by use~     of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer~     program analyzes the data and produces a real-time graphic and numeric data demonstrating~     the skin conductance response. The initiation of successful sympathetic blockade can cause~     rapid cessation of the skin sympathetic activity that leads to a decrease in skin~     conductance within seconds.~   "
50944|NCT02390310|"~     This is a research study in Kenya that will examine the outcomes of participants aged 10-15~     and 16 and older; and provider acceptability of the Shang Ring technique for male~     circumcision that would simplify use. The study will be in two phases:~      Phase 1 will explore the no-flip technique that has been used in China but will be used for~     the first time in Africa.~      Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.~   "
50945|NCT02390297|"~     Long term safety follow-up of Cal-1 recipients~   "
50946|NCT02390284|"~     Glaucoma is a progressive disease resulting in blindness. Determining the onset of the~     disease, predicting its severity and the benefit of pressure lowering eye drops is key to~     clinical management aimed at maintaining useful vision with advancing age. This study will~     longitudinally monitor a population of glaucoma suspects (with positive factors for the~     disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other~     standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells~     (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before~     dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with~     abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG~     will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography~     (OCT) and other ancillary tests every 6 months over 4 years.~   "
50947|NCT02390271|"~     Introduction: Health care that addresses the emotional regulation capacity of patients with~     schizophrenia confronted with daily stress may contribute to a less anxious life. A~     psycho-physiological training (cardiac coherence training; CCT) focusing on emotion~     regulation is known to decrease anxiety for non-clinical individuals.~      Methods: the investigators performed a pilot cross sectional survey to explore the benefits~     of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the~     program consisting in height to twelve weekly one hour session program during a 2-month~     follow-up. Standardised questionnaires were used before and after the intervention assessing~     anxiety, well-being outcomes, and how patients deal with stress and stressors.~   "
50948|NCT02390258|"~     This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects.~     Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of~     XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also~     without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be~     assessed following dosing for 10 days in Part 3.~   "
51180|NCT02387216|"~     The purpose of this study is to determine whether the combination of MM-121 plus docetaxel~     or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to OS in~     patients with heregulin-positive NSCLC.~   "
50949|NCT02390245|"~     Our goal is to conduct a 5-year prospective, randomized controlled trial to test an~     innovative, community-based intervention using posterior and anterior fundus photography of~     the optic nerve and macular images to improve access and utilization of eye care to detect,~     treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye~     diseases. Research shows that subject failure to attend follow-up eye care appointments~     diminishes any previous benefits of community screenings for glaucoma. Greater adherence to~     follow-up visits can reduce glaucomatous blindness.~   "
50950|NCT02390232|"~     In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the~     investigators will compare the composition of the gut microbiota from patients with simple~     steatosis with that with steatohepatitis.~      The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group~     and producing the genotoxin colibactin is a factor for developing NASH.~   "
50951|NCT02390219|"~     The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination~     therapy in subjects 12 years and older with CF and advanced lung disease and who are~     homozygous for the F508del CFTR mutation~   "
50952|NCT02390206|"~     The purpose of this study is to document the effectiveness of treating chronic post-stroke~     spastic patients with Botulinum Toxin type A.~   "
50953|NCT02390193|"~     Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public~     health problems, becoming a global epidemic. It is also known that the amount of~     displacement of overnight rostral fluid, from the lower limbs, is related to increased neck~     circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal~     disease. Method / Design: A clinical trial study aiming to assess the degree of~     collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been~     proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be~     performed before and after the hemodialysis session. Discussion: The incidence of CKD has~     increased, due to the increased number of cases of diabetes mellitus and hypertension. Our~     hypothesis is that the weight gain due to volume overload, observed in the interdialytic~     period, will exert a negative influence on the degree of collapsibility of the upper airways~     predispose to OSA in CKD patients.~   "
50954|NCT02390180|"~     Recent research indicates that fatty acids in food may have a taste. There is no lexicon to~     describe the sensation of the fatty acids, but participants frequently describe the~     sensation as bitter or sour. The proposed study will ask participants who have been screened~     for their ability to detect fatty acids to sort a variety of taste stimuli, including sweet,~     sour, salty, bitter, umami, and fatty acid tastes. Observing how the participants sort the~     stimuli will allow us to determine if the fatty acid taste is unique from other taste~     sensations.~   "
50955|NCT02389127|"~     Cirrhosis and advanced liver disease have been associated with an increased risk for~     hyperglycemia and type 2 diabetes mellitus (T2DM). The diagnostic yield of common tests used~     to define diabetes and insulin resistance in the general population differs significantly~     from the one observed in patients with liver disease. Glycosylated hemoglobin A1c (HbA1c), a~     reliable test to assess chronic glycemia and recommended both for the diagnosis and~     monitoring of T2DM, is neither accurate nor reliable in patients with cirrhosis. A~     validation study has not been performed to define its true usefulness in the setting of~     cirrhosis. The study aims to determine the level of HbA1c that better corresponds to the~     diagnosis of T2DM - as determined by an oral glucose tolerance test (OGTT) - and to~     correlate the levels of HbA1c with the average glucose over a 12-week period in patients~     with cirrhosis and known T2DM, in cirrhotic patients with different degrees of liver~     impairment as compared to patients with T2DM and no liver disease.~   "
50956|NCT02389114|"~     The primary hypothesis of this study is that the higher concentration of soy protein intake~     will increase satiety and decrease the energy intake at the subsequent meal.~      The secondary hypothesis is that the synergistic effect of soy protein and polydextrose will~     further increase satiety and reduce energy intake at the subsequent meal.~      The third hypothesis is that the ingestion of protein and polydextrose will differentially~     impact on satiety-related metabolism, i.e. blood glucose, insulin, urea, plasma amino acids,~     gut hormones and gastric emptying.~   "
50957|NCT02389101|"~     Lymphomas are classified as Hodgkin's or non-Hodgkin's lymphomas, of which especially the~     latter represent a heterogeneous group with varying patterns of prognosis, biological~     behaviour and response to treatment. 18F-FDG PET/CT is useful for staging and response~     monitoring but has the disadvantage of associated radiation exposure which may not be~     desirable for young patients. Advanced MRI techniques including diffusion weighted imaging~     (DWI) are increasingly used for improved lesion detection and characterisation of lymphomas~     and in the whole-body mode offer a promising radiation-free alternative to CT. Molecular~     imaging in turn is important in theranostics medicine where detection of therapeutic target~     is essential. The concept of theranostics has been successfully adapted to management of~     neuroendocrine tumors (NET) where peptide receptor radiotherapy (PRRT) is offered to~     patients progressing on treatment with long-acting somatostatin analogues.~      Recently in the investigator's hospital a case of diffuse large B-cell lymphoma (DLBCL) was~     initially misdiagnosed as NET because of high uptake of 68Ga-DOTANOC in pancreatic tumor at~     PET/CT. A PubMed search revealed a similar case report in bronchial tumor which turned out~     to be DLBCL (Jain et al. Clin Nucl Med 2014;39:358-359). Bearing these two cases in mind the~     investigators now aim to systematically study somatostatin receptor status (ssr) by~     measuring uptake of 68Ga-DOTANOC with PET/CT in patients with newly diagnosed non-Hodgkin's~     and Hodgkin's lymphoma. The imaging findings will be compared to immunohistochemically~     determined ssr-subtypes 2,3 and 5 obtained from pre-treatment fresh tumor samples and~     18F-FDG PET/CT which is part of standard diagnostic evaluation. Furthermore, whole-body MRI~     with DWI will be performed before, during and after chemotherapy to define the most~     sensitive and specific imaging method appropriate for routine diagnosis and follow-up. This~     study has potential implications for future response monitoring and follow-up imaging~     techniques in patients with malignant lymphoma and provides additional biologic~     characterization which may be useful for novel therapeutic approaches such as PRRT.~   "
50958|NCT02390154|"~     The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the~     body in a so called mass-balance study. This means to investigate how the study drug is~     absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from~     the body.~   "
50959|NCT02390141|"~     The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending~     doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety,~     tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are~     planned. Within each cohort, the subjects will be randomly assigned to five repeated doses~     of ZP4207 or placebo in a 3:1 treatment allocation at trial site.~   "
50960|NCT02390128|"~     This is an observational study in pregnant mothers and their newborn babies. The rationale~     of the study is to examine early markers of the effects of iodine insufficiency during~     pregnancy on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.~   "
50961|NCT02390115|"~     The stroke is the second cause of death and the first of disabilities in the world. Although~     a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper~     extremity present alterations of upper extremity, limiting the performance of daily~     activities even after 2 to 4 years of strokes. More recently used in neurological~     rehabilitation, the ability to promote sensory-motor facilitation is given to the Elastic~     Tape (ET). However, its safety and efficacy in the treatment of post-stroke individuals~     still require further investigation. Thus, the objective of this project is to evaluate the~     immediate effects of ET, applied to the paretic shoulder on proprioception during movements~     of abduction and flexion of the shoulder and muscle activation and kinematic variables for~     the reaching in chronic hemiparetic. Fifteen subjects with chronic hemiparesis will~     participate these crossover sham-controlled trial. Participants will be randomized into two~     condition: elastic tape (ET) followed by sham tape (ST- strapping) or ST followed by ET. One~     month of washout period was considered. The motor impairment and the dominance before stroke~     will be evaluated by Fugl-Meyer scale and the Inventory Side dominance of Edinburgh,~     respectively. ET will apply deltoid (anterior, middle and posterior). Assessment before and~     after the application of ET will be performed. For proprioception assessment (joint position~     sense) will be evaluated using a dynamometer. Absolute error for shoulder abduction and~     flexion at the 30° and 60° was calculated. For the assessment of motor performance in a~     functional task (reach a glass of water), spatio-temporal parameters (total duration of the~     motion, peak velocity, time to peak velocity) and three-dimensional joint kinematics of the~     trunk, scapula, shoulder, and elbow (total range of motion, joint angle maximum and minimum)~     will be used. Concomitantly, bilateral activation of the deltoid (anterior, middle and~     posterior), trapezius (upper and lower), serratus anterior and pectoral major will be~     assessed by electromyography during reach. The following electromyographic variables will be~     analyzed: activation amplitude, muscle onset and maximum and minimum activation. For~     statistical analysis, the normality and homogeneity tests will be applied. If the variables~     have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures~     gift will be applied. Otherwise it will be applied to non-parametric statistics Friedman.~     Will be considered a 0.05 significance level for all statistical tests.~   "
50962|NCT02390102|"~     The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in~     reducing the rate of red blood cell transfusion requirements in patients with aortic~     stenosis undergoing transcatheter aortic valve replacement.~   "
50963|NCT02390089|"~     Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD)~     versus healthy adults. This is of particular public health concern given that death~     secondary to aspiration pneumonia and lung infection is a leading cause of death in persons~     with PD. Swallowing and cough function are affected in PD, putting people with PD at~     significant risk for uncompensated aspiration (aspiration without adequate cough response).~     One challenge in the management of airway protective deficits related to PD is the chronic~     and progressive nature of the disease, where swallowing dysfunction appears subtly in the~     form of microaspiration, reducing the perceived urgency of the swallowing disorder by both~     clinicians and patients. The long-term goal of this research is to advance the management of~     airway protection deficits in patients with neurodegenerative disease in order to decrease~     morbidity and mortality due to aspiration related lung infection. The objective here is to~     further specify deficits leading to uncompensated airway compromise in PD in order to~     advance the clinical management of these patients, leading to an immediate positive impact.~   "
50964|NCT02390076|"~     The goal of this project is to use low-level light therapy (LLLT) to enhance neural~     metabolism in the prefrontal cortex of humans, and measure the effects of LLLT on~     attentional bias change following a single session of attention bias modification (ABM).~     LLLT is non-invasive, therapeutically beneficial, and promotes a wide range of biological~     effects including enhancement of energy production, gene expression and prevention of cell~     death. Previous research has indicated that human participants show a beneficial~     psychological effect, including improved mood and greater sustained attention, following a~     single treatment of LLLT to the forehead. ABM is a computer-based cognitive task designed to~     decrease the mood-congruent negative attentional bias frequently observed in depressed and~     dysphoric individuals. Previous ABM studies have led to decrease in clinical symptoms~     relative to a control condition. This study will explore whether the effects of LLLT on mood~     and attention could improve the potency of ABM, leading to greater attention change and~     greater improvement of mood relative to sham LLLT.~   "
50965|NCT02390063|"~     This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine~     that could be a new way to treat cancer. A vaccine that could alert the immune system to the~     presence of cancer cells in the body may enable the immune system to target and kill those~     cells effectively. This vaccine is intended to work by making the immune system kill cells~     that have a special protein (called 5T4) that is present on the surface of cancer cells. The~     vaccine is made up of two recombinant viruses (ChAdOx1 and MVA) that have been designed~     to produce the 5T4 protein and have been modified so that they are weakened and cannot~     reproduce themselves within the body like normal viruses. Once injected into the body, these~     viruses make the 5T4 protein and help the body's immune system to learn to target this~     protein and destroy cancer cells.~      This is a first-in-human study to evaluate the safety and immunogenicity of~     ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and~     intermediate risk localised prostate cancer patients who have either decided to have their~     prostate removed or are stable on active surveillance.~   "
50966|NCT02390050|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).~     Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as~     a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study will enroll both treatment~     naive and those subjects previously treated with one oral hypoglycemic agent (OHA).~     Approximately 320 subjects eligible for randomization will receive bexagliflozin tablets, 5,~     10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.~   "
50967|NCT02390037|"~     The objective of the study is to assess the incidence of safety outcomes in patients treated~     with Pipeline™ Flex embolization device with Shield Technology™.~   "
50968|NCT02390024|"~     Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it~     may present several adverse effects, such as the development of cognitive and~     psychopathological alterations. Patient-ventilator asynchronies occur frequently since the~     beginning of the MV. These asynchronies are associated with poor clinical outcome and could~     be responsible for the neuronal changes causing these alterations. The objective of this~     project is to analyze the influence of patient-ventilation asynchronies in the development~     of long-term cognitive/psychopathological impairments and to explore the molecular~     mechanisms that could explain of these alterations. An exploratory, observational,~     multicenter, non-interventionist study will be performed in 150 ICU patients. The continuous~     recording of asynchronies and other clinical variables during ICU stay and the results of~     neuropsychological assessments will enable to identify clinical clusters associated with~     cognitive/psychopathological impairments.~   "
50969|NCT02390011|"~     This is a single center pilot study testing the use of novel coil arrays with MR liver~     imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative~     adjustment of coil array geometry and design to optimize imaging characterstics. In Part B~     of the study, 40 patients with advanced solid tumors and at least one liver metastasis~     measuring > 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with~     the newly designed coil array, with the use of gadolinium contrast. Patients with liver~     tumors will have the option of undergoing a second MR liver scan during the course of~     subsequent systemic therapy.~   "
50970|NCT02389998|"~     This study is aimed at investigating the efficacy of placebo for symptom relief in children~     with abdominal pain related functional gastrointestinal disorders.~   "
50971|NCT02389985|"~     The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when~     administered in combination with weekly paclitaxel in women with recurrent or persistent,~     epithelial ovarian, fallopian tube or primary peritoneal cancer.~      Determine through pharmacokinetic evaluation(sometimes described as what the body does to a~     drug, refers to the movement of drug into, through and out of the body-the time and course~     of its absorption, bioavailability, distribution, metabolism, and excretion) whether or not~     the disposition of paclitaxel is affected by the concurrent administration of CRLX101.~   "
50972|NCT02389972|"~     The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML~     patients in China in the real-world clinical practice setting.~   "
50973|NCT02389959|"~     This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal~     Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis~     when used in conjunction with bipolar electrocautery.~   "
50974|NCT02389946|"~     The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus~     Eluting Coronary Stent System in the treatment of subjects with up to three native de novo~     or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary~     stent system.~   "
50975|NCT02389933|"~     Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide~     access to life-saving treatment with LCZ696 for patients that were not previously exposed to~     LCZ696 but have no other option to receive LCZ696 in their country prior to market~     authorization OR commercial availability, based on local regulatory and legal requirements.~   "
50976|NCT02389920|"~     Describe the purpose of the study: This study aims to evaluate the improvement of~     Dasatinib-related adverse events and to evaluate the treatment effect and safety by~     measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in~     Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.~   "
50977|NCT02389907|"~     Assessing the association between patients' perceptions of success with post-operative pain~     management and overall experience with care.~   "
50978|NCT02389894|"~     To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain~     injury in patients undergoing surgical aortic valve replacement (AVR).~   "
50979|NCT02389881|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple doses of TAK-058 in healthy non-elderly and elderly participants.~   "
50980|NCT02389868|"~     The purpose of this study is to evaluate the effects induced by the cholesterol-reducing~     drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to~     recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current~     study aims to characterize the biological and inter-individual variation of platelet's~     proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the~     exploration of changes induced by Lovastatin on the platelet's proteome may allow the~     discovery of modifications relative to the effects of statins on hemostasis and the lipid~     profile.~   "
50981|NCT02389855|"~     The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It~     employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused~     by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in~     nearly 300 procedures conducted at approximately 20 leading institutions across the United~     States. This post-market, multi-center retrospective study is designed to collect long-term~     follow-up data on patients who were treated previously with NBS.~   "
50982|NCT02389842|"~     Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K~     inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation~     phase where patients will receive either taselisib OR pictilisib in combination with~     palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with~     food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with~     the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part~     B).~      Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to~     palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off~     schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given~     intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles.~      Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will~     be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on~     and 7-days-off schedule.~   "
50983|NCT02389829|"~     Opioids are commonly used to treat migraine in North American Emergency Departments. We are~     comparing efficacy and adverse events of hydromorphone, an opioid, to that of~     prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine~     will be combined with diphenhydramine to prevent adverse events.~   "
50984|NCT02389816|"~     The purpose of this study is to evaluate the efficacy of two fixed doses of Lu AA21004 (10~     or 20 mg/day) after 8 weeks of treatment in patients with MDD in Japan~   "
51005|NCT02389543|"~     This is an open-label, randomized clinical study with two stages to assess the maximum~     tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone~     (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose~     escalation (Phase 1) and expansion (Phase 2).~   "
51080|NCT02388529|"~     This study is a single-center, randomized, double-blind, placebo-controlled study in~     patients with stable heart failure to evaluate the safety, tolerability, pharmacokinetics,~     and efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.~   "
50985|NCT02389803|"~     Study design:~      Double blind, randomized, placebo controlled study. Participants will be randomly assigned~     either to the intervention group or the placebo control group. Randomization for the two~     study groups will be made in a ratio of 1:1.~      The primary objective of the study is to assess the effect of 6-12 months treatment with~     nutritional supplementation standardized formula, in short and lean boys adolescents on~     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study~     are to assess the effect of 6-12 months treatment with nutritional supplementation~     standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time~     to puberty, quality of life and self-esteem The study will continue for 6 months of~     intervention versus active placebo, with additional optional 6 months (an extension period),~     in which participants at both groups, the intervention and the placebo, will be offered to~     continue their participation in the study with the study supplement.~   "
50986|NCT02389790|"~     The primary objectives of the study are:~      -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to~     severe active Crohn's Disease（CD）~   "
50987|NCT02389777|"~     This phase II clinical study will include fifteen healthy light skinned adult volunteers. At~     screening subjects will be given a sunburn test. This procedure involves exposing eight 1~     square cm areas of skin over increasing doses of simulated solar radiation (SSR). SSR is~     delivered by a 1,000-Watt xenon arc lamp, which emits ultraviolet wavelengths from 290-400~     nm, closely resembling natural sunlight. The Minimal Erythema Dose (MED) will be determined~     approximately 24 hours after initial exposure by using a chromometer. The MED is calculated~     by linear regression. Each test site is a one inch square area on the buttock or lower back.~     Sites 1, 2, 3, 4, 5 will be irradiated with 2 MED of SSR. Site 1 will not receive any ACCS~     treatment. Sites 2 and 3 will be treated with ACCS immediately after irradiation. 8-12 hours~     later or at bedtime, Sites 2,3,4,5 with ACCS at home. ACCS will also be applied 24 hours~     after SSR. Between 24-36 hours after SSR, subject returns to the Skin Study Center for~     Minolta chromometer assessment of erythema at all test sites, as well as for high resolution~     digital photography (Canfield). These assessments will be repeated at 48 hours and 72 hours~     post SSR. Data will be graphed to quantify rate of erythema resolution. Punch biopsies will~     be obtained at Site 1 (control) and Site 2 (SSR + immediate ACCS Rx). If a difference in~     erythema is observed between Site 1 and Site 4, a biopsy will also be obtained from Site 4~     (SSR + delayed ACCS Rx). Biopsy samples will be tested using Reverse Transcriptase~     -Polymerase Chain Reaction (RT-PCR) and/or immunohistochemistry for markers of UV~     inflammation such as Interleukin (IL)-6, Tumor Necrosis Factor (TNF) -alpha, etc. Subjects~     will continue to apply the ACCS twice daily on Sites 3 and 5 until study visit 5. An~     additional normal control skin biopsy may be performed in a subset of volunteers (4-5) to~     serve as reference control for the tissue analysis.~   "
50988|NCT02389764|"~     The goal of this clinical research study is to learn if Ofev® (nintedanib, also called~     BIBF1120) can help to control IBC. The safety of this drug will also be studied.~   "
50989|NCT02389751|"~     The goal of this clinical research study is to find the highest tolerable dose of ganetespib~     that can be given in combination with standard chemotherapy (paclitaxel and carboplatin) and~     radiation therapy in patients with esophageal cancer.~   "
50990|NCT02389738|"~     The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps,~     a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial~     cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree~     of permeability is regulated by the capillary endothelial cells in response to astrocytic~     signals. The strength of intercellular junctions (ex. tight junctions, adherins) amongst~     endothelial cells also plays a major role in permeability. Therefore, modulation of all~     these paracellular properties may decrease BBB integrity and thus improve drug penetration~     to the tumor bed. Previous studies utilizing the vasoactive peptide, Regadenoson,~     demonstrated transient increase in BBB permeability, allowing a 70kD dextran molecule to~     enter the brain of rodents. Thus, the investigators propose to evaluate brain interstitium~     concentrations of temozolomide pre and post Regadenoson using brain microdialysis. If~     Regadenoson successfully demonstrates effectiveness in disrupting the BBB, it could be of~     major importance in improving the outcome of patients with a variety of brain tumors and~     other neurologic illnesses.~   "
50991|NCT02389725|"~     What is the effect of two common tourniquet techniques on the first attempt success rate of~     peripheral intravenous cannulation?~   "
50992|NCT02389712|"~     The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or~     fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the~     trial is to have a better understanding of whether individuals with a particular gene type~     and other inherited biological markers will have a good response to fluoxetine or~     lamotrigine, or alternatively, would be more likely to have side effects to this medication.~   "
50993|NCT02389699|"~     Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during~     surgery followed by external-beam radiation to the entire breast may kill more tumor~     cells.The clinical trial is conducting to compare the effectiveness of radiation therapy~     during surgery and whole-breast radiation therapy in treating women who have undergone~     breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast~     cancer.~   "
50994|NCT02389686|"~     The role of NSM is still controversial, mainly because of concern about the oncologic safety~     of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most~     widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to~     assess the value of the INTRABEAM system for breast cancer.~   "
50995|NCT02389673|"~     Whether the patients with low grade ductal carcinoma in situ breast cancer should accept~     radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor~     cells. Giving radiation during surgery followed by external-beam radiation to the entire~     breast may kill more tumor cells.The clinical trial is conducting to find out the~     effectiveness of radiation therapy during surgery in treating women who have undergone~     breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.~   "
51006|NCT02389530|"~     Fluorescein is a dye agent that can be injected through an intravenous line. It has been~     shown to help tell the difference between brain tumor tissue and normal brain tissue when it~     is used together with a specialized filter on a microscope in the operating room. The~     investigators plan to study the use of fluorescein in the removal of brain tumors at a low~     dose.~   "
51079|NCT02388542|"~     The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri~     Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these~     worksites, quantify risk factor level in worksite populations and identify and train peer~     mentors to deliver an educational intervention to improve life style and enhance medication~     adherence among those at moderate to high risk of cardiovascular disease (CVD).~   "
50996|NCT02389660|"~     Effective, accessible, and affordable depression treatment is of high importance considering~     the large individual and economic burden of depression. There is ample support for the~     effectiveness of Internet-based Cognitive Behavioral Therapy (CBT) for depression which is~     considered a promising alternative to routine depression treatment strategies. Most evidence~     comes from randomized controlled trials, however, and not from research in routine practice.~      The European Comparative Effectiveness Research on Internet-based Depression Treatment~     (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT~     for adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial~     will be conducted in routine mental health care in Poland, and is a part of the bigger~     project funded by European Commission (Grant Agreement No: 603098). In this randomized~     controlled trial, a total of 150 patients with MDD will be assigned to one of two~     conditions: 1) blended CBT, 2) TAU. Respondents in both conditions will be followed until 12~     months after baseline (measures will be taken at baseline, 3 months, 6 months and 12~     months).~   "
50997|NCT02389647|"~     The purpose of this study is to use an iatrogenic model of stroke, meaning those strokes~     inadvertently caused by endovascular coiling of elective aneurysms, to study the biology of~     stroke in humans.~   "
50998|NCT02389634|"~     The purpose of the study is to identify novel genetic and protein markers for the process of~     cerebral vasospasm following aneurysmal subarachnoid hemorrhage.~   "
50999|NCT02389621|"~     The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo~     for the treatment of thrombocytopenia in patients with chronic liver disease who are~     undergoing elective invasive procedures.~   "
51000|NCT02389608|"~     Background: Transcranial direct current stimulation (tDCS) is currently considered a~     beneficial method for patients with neurological problems due to the modulation of cortex~     activity as well as the enhancement and prolongation of functional gains achieved during~     physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate~     effects of a session of tDCS over the primary motor cortex combined with functional~     electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance~     and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke.~     A further aim is to determine whether the effects of the combination of both stimulation~     methods are better than those achieved when each method is employed alone. Methods/design: A~     randomized, double-blind, crossover, cross-sectional study will be conducted involving 30~     stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will~     involve an identification and screening chart, the classification of motor impairment using~     the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified~     Ashworth scale), electromyography of the tibialis anterior muscle, static balance and~     cognitive dual-task balance (stabilometry) and plantar pressure. After the initial~     evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES~     + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis~     anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction;~     and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will~     be administered over the primary motor cortex and FES will be administered over the tibialis~     anterior muscle. The order of the different protocols will be randomized and both the~     evaluator and patients will be blinded to which protocol is being administered.~   "
51001|NCT02389595|"~     The purpose of this research study is to develop a vaccine against Human immunodeficiency~     virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at~     viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood~     from humans who have been exposed to HIV will be tested to see if the immune system will~     recognize the HIV and prevent infection.~      HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are~     parts on the AIDS viruses that help the virus infect these cells and other parts that help~     the immune system prevent viral infection by activating protective T-cells that fight HIV.~     Different T-cell populations are very important in most vaccines as they act as effectors~     that work as part of the immune system to recognize and fight off HIV infection. When~     effector T cells are activated by appropriate protective part(s) of the virus they either~     block HIV from reproducing or kill HIV infected cells. By finding these common protective~     parts of each of these human and animal AIDS viruses, the investigator hopes to make a~     vaccine that helps the immune system prevent HIV infection by avoiding parts that attack~     CD4+ T cells and may worsen HIV infection and selecting for parts that stimulate effector T~     cells that fight HIV infection.~   "
51002|NCT02389582|"~     Anticoagulation with heparin is indicated in several situations, such as acute coronary~     disease (in combination with antiplatelet therapy) for the prevention and treatment of~     venous thromboembolism and situations with high risk of thromboembolism. Recently, the~     latest trials on anticoagulation for stroke prevention on atrial fibrillation have shown an~     increased risk for acute mycardial infarction on patients submitted to new oral~     anticoagulants, such as dabigatran. The mechanism is still unclear, however, in this~     context, some previous studies about interaction between anticoagulants ( mainly heparin)~     and platelet aggregation have shown conflicting results: while some suggest an inhibitory~     effect of heparin on platelet function, others suggest that heparin could promote an~     increase in platelet activation. The present study aims to assess the effects of the LMWH~     Enoxaparin and direct thrombin inhibitor, Dabigatran, on platelet aggregation, studied and~     compared by different methods in patients with chronic coronary artery disease (CAD).~   "
51003|NCT02389569|"~     Objective: The purpose of this study is to evaluate clinical performance of resin-based~     composite Class I and II restorations in association with Biosilicate. Methods: Eighty~     patients with carious lesions will be receive restorations in premolars and molars, which~     will be randomly allocated in four experimental groups: G1 (Biosilicate, Adper Single Bond 2~     and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress Direct~     composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and IPS~     Empress Direct composite) — (n= 20 per group). Two trainer and calibrated evaluators fully~     blinded to the restorative technique used will be evaluate the restorations at 1 week~     (baseline), at 6, 12 and 18 months after placement using World Dental Federation (FDI)~     criteria. Data will be statistically analyzed.~   "
51004|NCT02389556|"~     ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo~     study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit~     lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4~     was identified as a novel adipokine modulating adipocyte differentiation. Thus, the~     investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and~     glypican 4 might affect progression of obesity in children. The investigators measure these~     molecules in Korean children, and investigate the association between these molecules and~     development of obesity.~   "
51103|NCT02388217|"~     The objective of the current study is to prospectively assess the effect of cannabis on pain~     and functional outcomes in a large group of patients with chronic pain.~   "
51007|NCT02389517|"~     This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide,~     ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that~     remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system~     kill abnormal blood cells or cancer cells and may also prevent the growth of new blood~     vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer~     cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy,~     such as dexamethasone, work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is~     not yet known whether lenalidomide is more effective with or without ixazomib citrate and~     dexamethasone in treating residual multiple myeloma.~   "
51008|NCT02389504|"~     An Investigation of Return to Play Exertion Protocol in Concussed Adolescents~   "
51009|NCT02389491|"~     The purpose of this study is to explore the effects of high density formula in early~     postoperative infants with congenital heart disease and to assess its safety.~   "
51010|NCT02389478|"~     The purpose of this study is to explore the effects of Oropharyngeal administration of~     colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the~     protect immune function of colostrum to very low birth weight infants, to improve the~     utilization of breast milk and reduce infection rates of very low birth weight infants.~   "
51011|NCT02389465|"~     Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that~     there is a link between depression and inflammatory disease. This study investigates the~     relationship between inflammation in the brain and depression. Comparing biological and~     psychological differences in depressed and non-depressed people allows researchers to find~     better ways to treat and prevent depression. All participants will have: neuropsych tests,~     an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant or~     placebo for eight weeks. The investigators are trying to correlate brain function with~     depression levels and biomarkers from the blood and spinal fluid.~   "
51012|NCT02389452|"~     Primary Objective:~      To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of~     Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).~      Secondary Objective:~      To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.~   "
51013|NCT02389439|"~     This study is a prospective, single arm, open-labelled clinical trial. The total number~     subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days.~     Dosing will be according to the body weight.~      All patients will have a blood smear examined daily during the first week by microscopy~     until parasite clearance (2 consecutive negative slides on two consecutive days; both~     asexual and sexual stages). A negative blood slide will be defined as parasite count~     negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as~     possible to 72h after the initial blood smear.~      Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14,~     21, 28, 35 and 42).~   "
51014|NCT02389426|"~     The aim of this study is to investigate the potential of Transcranial doppler (TCD) and~     Near-Infrared Spectroscopy (NIRS), more simple and non-invasive bedside methods than~     magnetic resonance imaging (MRI), to evaluate changes in the cerebral circulation between~     patients with MS and control subjects.~   "
51015|NCT02389413|"~     The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of~     PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or~     mild dementia due to AD.~   "
51016|NCT02389400|"~     Study Type: Interventional~      Study Design:~      Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking:~     Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying~     efficacy and tolerance of combination chemotherapy with methotrexate and cytosine~     arabinoside in newly diagnosed adult with Langerhans cell histiocytosis.~   "
51017|NCT02389387|"~     The purpose of this study is to facilitate coordination of transplant centers in North~     Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients~     with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.~   "
51018|NCT02389374|"~     This is a study assessing safety and efficacy of current national guidelines for the~     treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among~     the enrolled patients.~   "
51019|NCT02389361|"~     Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a~     classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol~     with Zaldiar (combination of paracetamol and tramadol).~   "
51020|NCT02389348|"~     This is a single-centre, open-label, dose finding study using induced blood stage malaria~     (IBSM) infection to characterize the pharmacodynamic interaction between OZ439 and DSM265,~     administered around 120 minutes apart for treatment of early Plasmodium falciparum blood~     stage infection. The study will be conducted in up to three cohorts (n=8 per cohort) using~     different doses of OZ439 and DSM265. The doses of OZ439 and DSM265 that will be investigated~     in the first cohort will be 200 mg of OZ439 and 100mg of DSM265, both administered as single~     doses around 120 minutes apart. Subsequent doses in subsequent cohort(s) will be determined~     following a review of observed OZ439 and DSM265 safety, and pharmacokinetic and~     pharmacodynamic interaction outcomes, particularly the antimalarial activity of the drugs~     given in combination as defined by parasite clearance kinetics. The doses used in Cohort 2~     and 3 may be adjusted but will not exceed the maximum acceptable doses predefined for this~     study (which are 400 mg for DSM265 and 500mg for OZ439) as determined in previous safety and~     pilot efficacy studies. The dose will be determined by the funding sponsor and the principal~     investigator (PI) following Safety Review team (SRT) and scientific evaluation. If no safe~     alternative dose can be determined the option exists to curtail the study to less than three~     cohorts.~      Each participant in the cohort will be inoculated on Day 0 with ~1,800 viable parasites of~     Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. On an~     outpatient basis, participants will be monitored daily via phone call and then daily (AM)~     from day 4 (until PCR positive for presence of malaria parasites). Once PCR positive they~     will be monitored twice-daily morning (AM) and evening (PM) until treatment, for adverse~     events and the unexpected early onset of symptoms, signs or parasitological evidence of~     malaria. On the day designated for commencement of treatment, as determined by qPCR results,~     participants will be admitted to the study unit and monitored. The threshold for~     commencement of treatment will be when PCR quantification of all participants is = 1,000~     parasites/mL. If the PCR quantification of any participant is = 5,000 parasites/mL and is~     accompanied by a clinical symptom score >5, or if clinical or parasitological evidence of~     malaria occurs in any participant before all participants have reached the treatment~     threshold (PCR quantification of = 1,000), then treatment of that participant will begin~     within a 24 h period.~      Following treatment with OZ439 and DSM265, participants will be followed up as inpatients~     for at least 48 hours to ensure tolerance of the treatment and clinical response, then if~     clinically well on an outpatient basis for safety and clearance of malaria parasites via~     PCR.~      Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) will occur on~     study day 16 ±3 days post OZ439 and DSM265 treatment unless required earlier. Early standard~     anti-malarial drug intervention can occur if either poor responses or fast responses are~     seen following OZ439 and DSM265 treatment. This is to ensure participant safety and to avoid~     participant inconvenience if useful data cannot be obtained. A poor response is defined as a~     decrease in parasitaemia of less than 20% from baseline by 3 days post OZ439 and DSM265~     treatment. A fast response occurs when, within the seven day period following the treatment,~     two consecutive PCR assessments in 48 hours are negative. However, pre-emptive treatment~     with Riamet® can commence whenever deemed necessary by the investigator. Participants will~     be monitored, either in clinic, or by telephone for three days to ensure adherence to~     Riamet® therapy.~      Participants will be treated with a single dose (45 mg) of primaquine as described in~     section 4.3 in this protocol at the end of their Riamet® treatment if gametocytes are~     identified, to ensure complete clearance of any gametocytes present.~      Adverse events will be monitored via telephone monitoring, within the clinical research~     unit, and on outpatient review after malaria challenge inoculation and antimalarial study~     drugs administration. Blood samples for safety evaluation, malaria monitoring, and red blood~     cell antibodies will be drawn at screening and/ or baseline and at nominated times after~     malaria challenge.~   "
51021|NCT02389335|"~     The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis~     is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant~     roles in β cell destruction.~   "
51022|NCT02389322|"~     The investigators select 500 subjects who meet the standard and are considered as study~     population I. Do specific gamma-interferon detection before the skin test， then inject~     intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative~     (TB-PPD) at different arm of the same subject and get 192 participants whose three kinds of~     detection result are all negative and are considered as study population II.Then,they are~     immune to the Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific~     gamma-interferon detection before the skin test， then inject intradermally with two dosage~     ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative~     rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of~     different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.~   "
51023|NCT02389309|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of dasatinib, cyclophosphamide, and temsirolimus that can be given to patients~     with advanced solid tumors. The safety of this drug combination will be studied. As~     secondary aim the study will evaluate treatment response to this combination and biological~     markers.~   "
51024|NCT02389296|"~     The aim of this study is to determine whether the work environment influences the role~     perception of nurses in psychiatric wards. This will be a comparative study. Questionnaires~     will be distributed to nurses working in psychiatric wards in 10 medical centers in Israel.~   "
51025|NCT02389283|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and~     peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones,~     joint capsule, tendons and ligaments leading to the consequential functional joint~     deterioration.~      The main goal of RA treatment is to achieve disease remission. The treatment of RA consists~     of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected~     when low disease or remission is not achieved with the first ones. Therapeutic response~     monitoring in RA should be closely managed. It is classically based on clinical exploration~     and laboratory tests. During the last decade, the resolution improvement of musculoskeletal~     ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the~     evaluation and monitoring of patients with RA, mainly due to its better capacity to detect~     synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive,~     reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects~     pathological synovial flow, which reflects synovial inflammation and has a demonstrated~     sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients~     with RA includes the detection of synovitis in B and Doppler mode in the joints accessible~     by ultrasound. There has been high variability in the literature regarding the number of~     joints that should be evaluated for an appropriate monitoring of the RA patients. The~     validity for monitoring the therapeutic response in long standing RA has been demonstrated~     in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution~     RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been~     studied~   "
51026|NCT02389270|"~     The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine~     samples will be collected at 3 different times of day (morning, noon, and evening) at urge~     sensation from all age groups of children who gained bladder control, i.e. from 3-18 years~     of age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor~     (BDNF) normalised to urinary creatinine will be analysed. Age and daytime related variations~     will be reported for both boys and girls. These results will contribute to understanding the~     role of neurotrophins in the physiology of lower urinary tract and pathophysiology of~     idiopathic and secondary hyperactive bladder in children.~   "
51027|NCT02389257|"~     Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields~     measurement.~   "
51028|NCT02389244|"~     INDICATION:~      Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone,~     intermediate or high-grade chondrosarcomas and chordomas~   "
51029|NCT02389231|"~     The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory~     T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI)~     in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of~     interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate~     that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs~     in patients with active wAHAI.~   "
51030|NCT02389218|"~     Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to~     standardized medication for treatment of early onset persistent atrial fibrillation (AF)~     without structural heart disease. The value of CBA in these patients has never been studied;~     the endpoints for persistent patients are much easier than for paroxysmal patients.~     Reduction in left atrial (LA) size will be compared versus patients on drug therapy and~     versus failing patients.~   "
51031|NCT02389205|"~     Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is~     bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity~     (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will~     produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding,~     and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle~     articular joint disease will affect lower limbs activities, and the functional activities~     will impaired.~      Review studies, in addition to physical therapy, Kinesio taping is a common intervention to~     improve other subjects' static balance, proprioception, functional ankle stability, correct~     poor posture.~      The main intervention of this study is physical therapy and Kinesio taping, expect to~     improve the stability and muscular strength of lower extremities, and balance, correcting~     gait and lower extremity functional activities of subjects with hemophilia.~   "
51032|NCT02389192|"~     Background:~      - Ebola is a virus that can spread quickly and causes serious disease. It is currently~     causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a~     new drug made of natural infection-fighting substances. Researchers want to see if it can~     treat Ebola.~      Objective:~      - To assess the safety of ZMappTM and how the body processes it. To measure the immune~     system response to ZMappTM.~      Eligibility:~      - Healthy people 18 50 years old.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and~          urine tests. They will have an electrocardiogram (ECG) to measure heart electrical~          activity. Small pads will be stuck to the arms, legs, and chest.~        -  Participants will be admitted to the hospital. They will have a physical exam,~          medication review, and blood samples.~        -  Two intravenous (IV) lines will be placed into separate arm veins. A needle will be~          used to guide plastic tubing into the veins. One will be used to take blood samples.~          The other will be used to give the study drug.~        -  Participants will be given drugs to help prevent side effects.~        -  Participants will be given the study drug by IV over 10 12 hours. Participants will be~          monitored closely and vital signs taken frequently. They may have another ECG.~        -  Blood samples will be taken before, during, and after the infusion.~        -  Participants will stay in the hospital 1 or 2 nights after receiving the drug.~        -  Participants will have several study visits over 90 days after getting the study drug.~          They will be asked about side effects. They may have a physical exam, and blood may be~          drawn.~   "
51078|NCT02388555|"~     Currently there is paucity of information on the prevalence of pre-operative coronal~     imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical~     outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to~     propose a novel classification system and to investigate whether pre-operative coronal~     imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were~     recruited.~   "
51118|NCT02388022|"~     The purpose of the study is to gather clinical and radiographic outcome data from patients~     who have undergone treatment with an expandable interbody spacer.~   "
51033|NCT02389179|"~     Much research on vitamin D status has focused on seasonal variations in serum 25(OH)D levels~     in populations living at high altitudes and those of light-skinned Caucasian extraction,~     with little work done in multi ethnic populations living closer to the equator with regards~     to Vitamin d supplementation, prevalence, predictors and associations of hypovitaminosis D -~     the assumption, perhaps being vitamin D deficiency is unlikely in locations of plentiful~     sunshine. There is a dearth of studies on Vitamin D status in a group of subjects at~     especially high risk of falls/fractures i.e. post-menopausal women with osteoporosis living~     in South-East Asia. It is possible that differences in geography and ethnicity/culture~     amongst women with post menopausal osteoporosis (PMO) in Malaysia may necessitate~     supplemental Vitamin D doses that differ from those prescribed to North American Caucasians.~      There is no unified consensus on the dose of Vitamin D supplementation. Neither is there~     agreement on definitions of sufficiency with some researchers targeting levels of serum~     25(OH)D of >20ng/ml and others aiming for levels above 30ng/ml. The Institute of Medicine~     (IOM) 2010 guidelines, aiming for a lower serum 25(OH)D target of 20ng/ml, advocates~     maintenance doses of 600 IU/day in Postmenopausal women aged 51-70 and 800 IU/day for those~     aged >70 years. On contrary, the Endocrine Society 2011 guidelines state that maintenance~     doses up to 1500-2000 IU/day may be required to attain a higher optimal target of >30ng/ml.~     On addition, the 2014 National Osteoporosis Foundation Guidelines recommended that the~     Vitamin D level should be brought up to approximately 30ng/ml, and to maintain at this level~     taking into account those with limited sun exposure, obese and dark skin individuals, the~     daily requirement ranges from 800-2000 IU/day.~      The investigators therefore designed a prospective randomized controlled trial comparing~     efficacy and safety of a low (900 IU/day) and high (1800IU/day and 3300IU/day) maintenance~     dose of Cholecalciferol (Vitamin D3) amongst community dwelling Indian and Malay with PMO~     living in Kuala Lumpur, Malaysia.~      Hypothesis of the study is despite abundant exposure to sunlight, which is the main Vitamin~     D supplier, those who dress conservatively and individuals with darker skin may require a~     higher dose of Vitamin D to maintain sufficiency (>30ng/ml).~   "
51034|NCT02389166|"~     Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV~     session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial~     Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when~     NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high~     flow oxygen delivery system used a heated humidifier and heated breathing circuit. In~     observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory~     failure. Oxygenation is better than under high-concentration mask and work of breathing is~     reduced.~      The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to~     oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions~     (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the~     session), during the first two NIV sessions~      Study design : Prospective, randomized, controlled, multicentric, open clinical trial with~     two groups:~        -  control group with conventional clinical management, oxygen therapy and sequential used~          of NIV~        -  Optiflow group with high flow oxygen delivery system, conventional clinical management~          and sequential used of NIV for a period of 36 hours at least.~      Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for~     hypoxemic respiratory failure.~   "
51035|NCT02389153|"~     The main focus of the pilot study is to evaluate the feasability and effectiveness of a~     collaborative care intervention for patients suffering from a coronary heart disease (CHD)~     with insufficient controlled health related risk factors in their lifestyle. The design of~     the study is a wait list control design. 30 patients will receive treatment immediately~     after submission, the other 30 after 6 months. An interdisciplinary team, including a care~     manager for each patient, will offer an individualized treatment plan, based on shared~     decision making for each patient to reduce risk factors and improve quality of life.~   "
51036|NCT02389140|"~     The physiological response at the myofascial trigger point (MTrP) to massage is not known,~     yet would provide important objective evidence for a treatment effect and clarify the~     resolution process of a MTrP.~   "
51037|NCT02389088|"~     The purpose of this study is to evaluate the effect of increased circulating androgens on~     estradiol production by the granulosa cells in response to FSH stimulus.~   "
51038|NCT02389075|"~     This study plans to learn more about the relationship between systemic autoimmune disease,~     such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon,~     and the changes in colon tissue.~   "
51039|NCT02389062|"~     This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten~     ingestion in celiac disease patients who are following gluten free diet for at least a~     period of one year. These noninvasive markers may be helpful to monitor the silent~     intestinal damage, possibly resulting from the accidental consumption of gluten due to cross~     contamination of gluten free diet.~   "
51040|NCT02389049|"~     This study is designed to study DNA sequencings for mutations in a research genetic test~     panel of genes (which contains all 32 known and/or published genes associated with PCD). The~     study aims to show that about 70% of PCD patients have biallelic mutations in one of these~     genes. This project will enroll patients who have already had a clinical evaluation, and~     have clinical features consistent with PCD.~   "
51041|NCT02389036|"~     Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and~     mortality and increase health care costs. Critically ill patients are particularly~     susceptible to these infections and have an even higher mortality. One intervention that has~     gained much interest in the medical literature for reducing infection rates and deaths from~     HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application~     of antibiotic paste to the mouth, throat, stomach and a short course of intravenous~     antibiotics. The evidence supporting the use of SDD for saving lives and preventing~     infections is actually quite strong. However, health care professionals in many parts of the~     world have refrained from using SDD due to fears of the effects of overuse of antibiotics on~     the frequency of infections with resistant bacteria such as multi-resistant Gram negative~     organisms, MRSA and Clostridium difficile.~      SuDDICU-ANZ is a cross-over, cluster randomised trial comparing the effect of using~     selective decontamination of the digestive tract (SDD) plus standard care, to standard care~     alone on hospital mortality in patients receiving mechanical ventilation in the intensive~     care unit (ICU).~      Secondary outcomes include an ecological assessment and a long-term health economic~     analysis.~   "
51042|NCT02389023|"~     The purpose of this study is to evaluate the effectiveness of negative pressure incision~     management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™~     Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications~     including surgical site infection (SSI) and non-infectious complications in patients~     undergoing vascular surgery with groin incisions.~   "
51181|NCT02387203|"~     The purpose of this study is to determine the impact of antibiotic therapy on the disease~     progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).~   "
51043|NCT02389010|"~     A novel method (PCT n. WO 2010/007502 A2, 2010) has been developed to obtain platelet gel~     from umbilical cord blood (CBPG). The main advantages so far identified in CBPG as compared~     to platelet gel derived from adult platelets relate to the lack of microbiological~     contamination in the former and to a different profile of growth factors concentrations,~     such as a higher content of VEGF and lower content of TGF in CBPG. Recent developments have~     led to a procedure in which CBPG can be prepared, stored in a cryopreservation bag and~     applied to the skin ulcer without breaking the sterility chain. In spite of promising~     results on allogeneic CBPG, a randomized clinical trial of sufficient statistical power to~     detect significant advantages (clinical and economical) will be performed in patients~     affected by diabetic foot ulcers and randomly treated with CBPG versus standard local~     medications (SLM).This study is a multicenter (8 centers) controlled randomized clinical~     trial. Outcomes: (1) primary objective is to evaluate the number of closed skin ulcers~     within 4 weeks of treatment with CBPG vs standard local medications; (2) secondary~     objectives are percent skin ulcer closure area, number and type of adverse events and cost~     of treatment. Sample size calculation: 95 + 5 (dropout) test and 95 + 5 (dropout) control~     patients ensure 80% power to detect as statistically significant (p<0.05) >60% healing in~     test vs 40% healing in control.Each clinical centre has been invited to enrol 15 treated and~     15 control patients, according to local availability in 12 months. CB units are routinely~     collected after mother's informed consent before and after placenta delivery in accredited~     public cord blood banks belonging to the Italian Cord Blood Network (ITCBN) coordinated by~     the Centro Nazionale Sangue (CNS). After storage and transportation at monitored room~     temperature, the units will be processed for the preparation of CBPG within 48 hours of~     collection. CBPG will be prepared according to standard procedures with a defined final~     platelet concentration (0.8-1.2 x 109/L). The CBPC units will be finally cryopreserved in a~     -80°C freezer in view of the clinical use of the CBPG, which will require thawing at 37°C in~     a waterbath and activation with Calcium gluconate. For SLM, each clinical center will use~     their validated standard procedures.~   "
51044|NCT02388997|"~     Population surveys have shown a positive correlation between increased levels of total serum~     IgE and bronchial hyperreactivity. However, it is also clear that exacerbations of asthma~     are frequently triggered by viral respiratory tract infections, especially those caused by~     human rhinovirus (RV), also known as the common cold virus. This protocol explores the~     relationship between rhinovirus and allergen/IgE provoked inflammation. Experimental~     challenges with human (RV) result in more persistent upper respiratory tract symptom scores~     in asthmatics than in controls. Asthmatics with high levels of IgE also show greater~     sensitivity to methacholine and higher levels of eNO than those with low levels of IgE.~     These data suggest that patients with asthma and high levels of IgE are more likely to have~     pre-existing inflammation of the airways before virus challenge. This study is being done to~     determine whether anti-IgE therapy (with omalizumab) will lead to a significant decline in~     inflammatory biomarkers prior to virus inoculation, and thus reduce the severity of clinical~     manifestations after an experimental human RV challenge.~   "
51045|NCT02388984|"~     The purpose of this study is to evaluate the efficacy and safety of Compound Danshen~     Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood~     Stasis).~   "
51046|NCT02388971|"~     The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in~     participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving~     standard-of-care (SOC) therapy.~   "
51047|NCT02388958|"~     Gestational diabetes mellitus (GDM) is associated with short-term and long-term~     complications for infants and mothers. The management of GDM during pregnancy focuses on~     reducing risks to the infant associated with hyperglycemia. The postpartum management of GDM~     focuses on reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM~     identifies up to 31% of parous women who will eventually develop T2DM and approximately 50%~     of women diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived~     risk of developing short-term and/or long-term complications of GDM may influence women's~     likelihood of engaging in diet modification, the mainstay of treatment of GDM, both during~     and after pregnancy. If sustained after delivery, diet modifications introduced as treatment~     for GDM could affect maternal weight changes during and after pregnancy, which could in turn~     affect T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of~     developing T2DM, dietary choices, or weight gain (and retention) during versus after~     pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the~     perceived risk of developing T2DM among women with GDM during and after pregnancy, (2)~     characterize dietary choices of women with GDM during and after pregnancy, and (3)~     characterize weight changes of women with GDM during and after pregnancy as compared to~     women without GDM.~   "
51048|NCT02388945|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     validity and security of domestic APD machine compared with the patients followed CAPD.~   "
51049|NCT02388932|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy in treating patients with head and neck cancer that has spread from where it started~     to nearby tissue or lymph nodes and is at high risk for continuing to spread because the~     patient cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a~     specialized radiation therapy that delivers radiation directly to the tumor in smaller doses~     over several days, which may kill more tumor cells and cause less damage to normal tissue.~   "
51050|NCT02388919|"~     Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with~     advanced non-small lung cancer, with placebo control.~   "
51051|NCT02388906|"~     The purpose of this study is to determine whether nivolumab is better than ipilimumab to~     prevent recurrence of melanoma.~   "
51052|NCT02388893|"~     As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective~     endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team~     including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry~     is a prospective, national registry of patients with IE. From January 2013 data from~     endocarditis board were prospectively recorded using standard definitions during the~     hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of~     IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.~   "
51053|NCT02388880|"~     The purpose of the study is to evaluate the physiological response to application of the~     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.~     The study will evaluate the physiological response to intrathoracic pressure regulation~     (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who~     are on ventilatory support.~   "
51054|NCT02388867|"~     In the present study the investigators will evaluate MMPs. serum levels variations in~     patients affected by critical limb ischemia, before and after lower limb surgical~     revascularization through venous or prosthetic bypass.~   "
82089|NCT01982916|"~     The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean~     patients with AGR tablet.~   "
51055|NCT02388854|"~     Endometriosis, defined as the presence of endometrial tissue outside the uterine cavity,~     affects 6-10% of the general population of women in childbearing age.~      The pathogenesis of the disease is unknown. The purpose of this study is to evaluate the~     influence of certain polymorphisms of genes Transforming growth factor beta 1~     (TGFB1),Vascular endothelial growth factor (VEGF), Epithelial growth factor receptor (EGFR)~     and Platelet-Derived Growth Factor (PDGF) knowns to be involved in angiogenesis, tissue~     remodeling and proliferation, phenomena necessary for the growth of ectopic foci of~     endometrial tissue , and genes X-ray repair cross-complementing protein 1 (XRCC1), X-ray~     repair complementing defective repair in Chinese hamster cells 3 (XRCC3) and xeroderma~     pigmentosum group D (XPD) involved in DNA repair systems, needed in case of damage from~     oxidative stress, another potential factor involved in the pathophysiology of endometriosis.~     The study focus on the Sardinian population, known to have unique genetic characteristics~     due to geographical isolation.~   "
51056|NCT02388841|"~     ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic~     thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to~     determine the association between thrombus localization and risk factors, accompanying~     disorders, D-dimer and the red blood cell distribution width (RDW) in patients with~     pulmonary embolism.~   "
51057|NCT02388828|"~     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received~     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol~     have received lentiviral modified T cells engineered to express an anti-mesothelin scFv~     Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses~     are a subfamily of retroviruses. This protocol is designed in adherence with the November~     2006 Food and Drug Administration (FDA) Guidance for Industry, Monitoring for Delayed~     Adverse Events and Supplemental Guidance on Testing for Replication Competent Retrovirus~     in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in~     Clinical Trials Using Retroviral Vectors  and involves up to 15 years of monitoring of~     subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo~     biannual visits for a blood test evaluating persistence of cells with retroviral vector~     sequences, chemistry, hematology and tumor markers (as applicable). On annual visits,~     subjects will further undergo a physical exam and medical history (including concomitant~     medications and adverse events) with careful attention to features possibly related to~     retrovirus-induced diseases~   "
51058|NCT02388815|"~     To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when~     used at home by children with diabetes.~   "
51059|NCT02388802|"~     Ten patients will undergo uterine transplantation.~   "
51060|NCT02388789|"~     The purpose of this study is to investigate whether mechanoreceptor sensitivity of the sole~     of the feet increases with increased foot temperature and how a heightened sensation may~     improve characteristics of balance control and gait. As an extension, the investigators also~     want to determine whether lower limb movement is an efficient activity of increasing foot~     temperature. There are several objectives of this study. The investigators want to determine~     the effect of active recovery (via lower limb movements) on increasing plantar temperature,~     determine the effect of increased plantar temperature on plantar sensation and determine the~     effect of increased plantar sensation on balance control and gait characteristics.~     Participants will be asked to complete various tasks under different conditions. Conditions~     include decreased feet temperature via ice bath emersion, baseline feet temperature~     (participant's normal temperature after a ten minute equilibration period), and increased~     feet temperature via active movement of the lower limb. Tasks include walking across the~     room, performing active movement of the lower limb and a 10 minute treadmill walk. Gait~     movement will be collected with a three-dimensional motion capture system (Optotrak) and~     force plates. Feet temperature and sensation information will be collected with a~     temperature probe (infrared) and monofilaments.~   "
51061|NCT02388776|"~     This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed~     pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in~     severe burn patients to provide preliminary information on the nature of coagulation~     abnormalities and compare subject ROTEM coagulation profiles within 24 hours of burn injury~     (day 1) and on days 2, 3, 5, 7, 14 and 21 after burn injury.~   "
51062|NCT02388763|"~     The purpose of this study is to evaluate the functional vision of 2 daily disposable~     silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at~     high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced~     humidity environment.~   "
51063|NCT02388750|"~     This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis~     or rescue of single or multiple fraction radiation induced nausea and vomiting. This~     prospective study employs a parallel arm design, allowing for inclusion of patients with~     pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients~     receiving radiotherapy known to have a low or moderate emetogenic risk will receive every~     other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use~     of rescue medication, and impact on quality of life will be monitored during and after~     radiation treatment completion.~   "
51064|NCT02388737|"~     This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom~     endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate~     treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of~     vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as~     to determine the clinically recommended dose for vonoprazan for maintenance therapy in~     erosive esophagitis.~   "
51065|NCT02388724|"~     The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus~     lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8.~   "
51066|NCT02388711|"~     The goal of the project is to conduct a prospective, randomized-controlled clinical trial to~     determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts~     transitional care quality, patient cognition/function, caregiver stress and 30-day~     rehospitalizations in patients with documented diagnoses of dementia discharged from the~     hospital to the community.~   "
52661|NCT02367872|"~     The purpose of this study is to examine the effects of renal and hepatic impairment on~     TAK-272 pharmacokinetics with a single oral administration of TAK-272 in patients with renal~     or hepatic impairment.~   "
51067|NCT02388698|"~     The addition of concurrent chemotherapy to definitive radiation has improved the 5-year~     survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV~     DNA predates clinical recurrence and/or improves the accuracy of metabolic response on~     FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally~     advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival~     and overall survival. In addition plasma HPV can be used to monitor response and detect~     early recurrence. Prospective study will recruit 20 patients with locally advanced cervical~     cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the~     accuracy response on post-therapy FDG-PET scan at 3 months.~   "
51068|NCT02388685|"~     The goal is to test the ability to detect improved calf muscle perfusion and energetics in~     PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will~     be randomized to a 12 week home exercise program or no program (control).~   "
51069|NCT02388672|"~     Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals with~     health benefits. Most investigations have so far focused on the beneficial effects of~     caffeine but knowledge about non-caffeine coffee compounds such as chlorogenic acid (CGA) is~     scarce. The reducing risk of a variety of diseases following CGA consumption has been~     mentioned in recent basic and clinical studies. However, there is a lack of studies that~     examine the behavioral effects of CGA. This study aims to fill this gap.~      In a randomized double-blind study, the investigators test the acute effects of coffee~     enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood~     glucose, and heart rate, and on psychological functions such as mood and cognitive~     performance in 30 healthy adult subjects (18-40 years).~      Participants will be allocated to an intervention plan using computer-generated random~     numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with~     high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224~     mg), or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee~     bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal~     total CGA and placebo, or (5) no treatment group. Upon arrival in the laboratory,~     participants will complete a 24-hour food recall, a psychometric test battery, and mood and~     cognitive performance tests. The tests will be repeated 40 min following CGA application,~     which coincide with the approximated peak of CGA blood concentrations and at 120 min post~     treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to~     treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched~     coffee will be compared to GCE supplement for each of the groups of variables.~   "
51070|NCT02388659|"~     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma~     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in IDH~     mutated gliomas and IDH wild type gliomas.~   "
51071|NCT02388646|"~     The goal of this study is to explore the effectiveness of a commercially available,~     over-the-counter knee brace in the conservative treatment of knee osteoarthritis.~     Participants will either be fitted with a brace and told to wear it every day during normal~     activities, fitted with the brace and given instructions on a set of quadriceps~     strengthening exercises to complete twice daily, every day, or be given the exercise~     instructions, but not fitted with a brace. Functional and subjective outcomes will be~     collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the~     effectiveness of bracing alone versus a home exercise program, and whether the combination~     of those provides the most therapeutic benefit to participants.~   "
51072|NCT02388633|"~     Severe hypercholesterolemia produced by conditions such as heterozygous familial~     hypercholesterolemia is associated with multiple complications including premature~     atherosclerotic disease. There is evidence that microvascular perfusion, particularly flow~     reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal~     RBC deformability, and an imbalance between vasodilators and vasoconstrictors. There is~     little is currently known about acute changes in microvascular blood flow and microvascular~     rheology that occur in response to plasmapharesis which is used in some patients to lower~     critically elevated cholesterol levels. Our research group has pioneered CEU methods for~     assessing myocardial and skeletal muscle perfusion, and has previously demonstrated in~     pre-clinical models that acute hyperlipidemia produces a reduction in microvascular RBC~     transit rate. In this study, the investigators will assess acute changes in microvascular~     perfusion in patients undergoing clinically-indicated plasmapharesis.~   "
51073|NCT02388620|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability~     of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic~     function (based on Child-Pugh classification) as compared to demographically-matched control~     subjects with normal hepatic function.~   "
51074|NCT02388607|"~     Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It~     is characterized by clinical symptoms combining positive and negative symptoms and thinking~     disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play~     an important part in adaptation of these patients in their every-day life, and to affect~     their clinical symptomatology. Among them, there are deficits in sustained attention which~     are associated with a difficulty for these patients to maintain efficiently their cognitive~     activity on a source of stimulation or task. This basic attentional process is fundamental~     for the efficiency of the overall of cognitive processes, and so for all behaviors directed~     on an aim. The question of whether or not patients with schizophrenia have difficulty~     sustaining attention is of high relevance, in the sense that it could undermine performance~     on nearly any task and so provide a compelling causal explanation of many other impairments~     observed in these patients. Yet it has not been conclusively answered in over four decades~     of research. Consequently, the main objective of the protocol is to evaluate sustained~     attention abilities in schizophrenic patients and to better understand the specific~     functioning of cognitive and neural mechanisms underlying these abilities (attentional~     resources and cognitive control mechanisms).~   "
51075|NCT02388594|"~     This is a triple cohort, open-label pilot study of the safety and antiviral activity of a~     single infusion of autologous CD4+ T cells genetically modified at the CCR5 gene by Zinc~     Finger Nucleases SB-728mR (ZFN Modified CD4+ T Cells) using electroporated mRNA with or~     without the prior administration of two different doses of cyclophosphamide.~   "
51076|NCT02388581|"~     Aims: A nationwide study to prospectively validate~        1. The complete histological and molecular remission rate for antibiotics as 1st-line~          therapy for early-stage Hp-positive gastric pure (de novo) DLBCL~        2. The durability of complete histological remission after antibiotics~        3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in~          prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL~        4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in~          Taiwan.~        5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp~          infection after antibiotics.~   "
51077|NCT02388568|"~     The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle~     counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss~     achieved during a prior 14-week dietary run-in.~      14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight~     in the 14-week dietary run-in. This loss will be achieved with the provision of weekly,~     group lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that~     combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a~     frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are~     expected to achieve the 5% criterion loss during the 14-week run-in.~      A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30~     and ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in~     the 4-month run-in period. Prior to enrollment, all participants will have a history,~     physical exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly~     group sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check~     their health and blood tests will be repeated. The investigators anticipate that 136 (75%)~     participants will lose 5% or more of initial weight and qualify for randomization.~     Participants who do not lose 5% will be provided a list of weight loss resources (e.g.,~     other programs) to facilitate their continued weight management.~      12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or~     more of initial weight in the run-in period will be randomly assigned, in double-blind~     fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must~     have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or~     equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational~     Drug Service at the Hospital of the University of Pennsylvania. Prior to randomization, all~     participants will complete a second brief history and physical examination, as well as an~     EKG and blood tests. Medication will be dispensed at the randomization visit and at brief~     medical visits that follow. Over the 1 year, all participants will participate in 16 group~     lifestyle modification classes designed for weight loss maintenance, approximately half of~     which will be delivered by group conference call.~      Primary outcome measure. The primary endpoint is change in body weight (in kg), as measured~     from randomization to month 12. The co-primary end-point is the percentage of participants~     in the two groups that, at month 12, maintained the ≥5% reduction in body weight achieved~     during the 14-week dietary run-in period. Secondary efficacy endpoints include changes in~     CVD risk factors, glycemic control, and quality of life, as measured from randomization to~     month 12. Exploratory endpoints include changes in these CVD and related outcomes, as~     measured at the start of the 14-week run-in period to month 12. The investigators also will~     examine the percentage of participants in the two groups who at month 12 achieved losses of~     ≥5%, ≥10%, and ≥15% of initial weight, as measured from the start of the run-in period.~      Safety endpoints will include physical examination, electrocardiogram, adverse events (AEs),~     standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity~     Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).~      Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization~     ratio, assumes a 20% drop-out rate (at month 12) and was estimated to be adequate to~     evaluate the primary endpoint with power ≥90% (P=0.05, two-sided test). The investigators~     predict a difference in weight change between the two groups (from randomization to month~     12) of 4 kg (SD=3.5). Pre-specified data analysis will be performed on the full analysis~     set, comprising all randomized individuals exposed to trial drug with at least one~     post-randomization weight assessment.~   "
51081|NCT02388516|"~     There is a growing body of data suggesting that vitamin D modulates the host's immune~     response to acute respiratory infection (ARI). The primary aim of this study is to determine~     whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of~     microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh.~     Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B)~     incidence of clinical ARI (without the need for positive microbiology), and C) quantitative~     density of pneumococcal carriage. Infants will be followed from birth until 6 months of~     life. Among infants who meet at least one of the specific case definitions for ARI (see~     'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples~     will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel~     (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and~     parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.~   "
51082|NCT02388503|"~     This study is designed to identify the minimal effective tested dose of fruit extract~     consumed with a bread which provides a reduction in venous post-prandial blood glucose~     compared to a reference bread.~   "
51083|NCT02388490|"~     This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin~     to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.~   "
51084|NCT02388477|"~     The purpose of this study is to examine healing after rotator cuff repair in subjects either~     treated with Doxycycline or placebo post-operatively.~   "
51085|NCT02388464|"~     This is a Phase 1, single-center, randomized, double-blind, single ascending dose,~     placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart~     failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability,~     and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).~   "
51086|NCT02388451|"~     15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis~     of MCI and who provide informed consent will undergo cognitive and functional assessment to~     confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive~     Impairment Computerized Assessment Battery will be performed. Subjects will then participate~     30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams~     testing will be repeated after 15 sessions and at completion of the study.~   "
51087|NCT02388438|"~     This study evaluates the demineralized bone matrix in Hallux valgus.~   "
51088|NCT02388412|"~     Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising~     results for detecting vulnerable plaques in some pilot studies.~      In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for~     non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).~   "
51089|NCT02388399|"~     In this study, the investigators sought to evaluate the feasibility of estimating external~     hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from~     pressure wire pullback tracing.~      In addition, the investigators will also evaluate detailed plaque geometry and vulnerability~     using optical coherence tomography along with the hemodynamic stress.~   "
51090|NCT02388386|"~     The investigators aim to develop a novel and wireless method for monitoring medication~     adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus~     Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to~     monitor medication compliance. The edible sensor has at its core a silicon-based integrated~     circuit measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is~     activated by gastric acid resulting in an electrochemical redox reaction and an electrical~     charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable~     device such as a smart phone. This strategy of medication adherence differs from~     conventional adherence monitoring including pill counting and patient-recall by precisely~     tracking medication ingestion.~   "
51091|NCT02388373|"~     The aim of this study is to compare two licensed asthma inhalers and to then evaluate the~     safety of reducing treatment when patient's asthma is in control. The inhalers used in this~     study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed~     inhaler called Flutiform®. National guidelines recommend that asthma medication should be~     increased when patients are experiencing worsening of their asthma, and reduced when asthma~     is in control. However, it is likely that in daily clinical practice some patients are~     over-treated. It is therefore necessary to conduct more studies which demonstrate that~     reducing treatment dosage can be done safely.~      This study has two phases. In the first phase the investigators aim to recruit 224 patients~     through approximately 40 clinics in the UK and Ireland. One third of these patients will be~     selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use~     high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will~     compare how well asthma was controlled between the two groups.~      After phase 1 those patients who used Flutiform and did not have any problems with their~     asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage~     Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the~     end of phase 2 the investigators will compare asthma control between the two groups.~      This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial~     funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18~     months and each patient will spend a maximum of 6 months in the study.~   "
51092|NCT02388360|"~     The purpose of this study is to determine the influence of topical prostaglandin analog~     (PGA) medication on corneal biomechanical properties in patients undergoing PGA treatment~     for open-angle glaucoma.~   "
51093|NCT02388347|"~     To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects~     and healthy adult female subjects of non-childbearing potential.~   "
51119|NCT02388009|"~     This is a phase I, single-blind, randomized, placebo-controlled, single-center study in~     healthy subjects using a staggered approach to dosing.~      30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without~     adjuvant or placebo.~   "
51120|NCT02387996|"~     The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor~     size in subjects with metastatic or unresectable bladder cancer.~   "
61155|NCT02256735|"~     Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the~     ECG in comparison to placebo and moxifloxacin~   "
51094|NCT02388334|"~     Half the MS patients require a natural (non professional) caregiver's support for daily~     living activities and this level of investment increases with the degree of disability.~      The caregiver's role is an essential key factor in the therapeutic alliance between the~     patient and heath professionals. The impact on the natural caregivers' Quality Of Life (QOL)~     and their expectations for the global quality of management are not documented, notably~     because of the lack of adapted tools.~      The aim of the investigators' project is to develop, from the caregivers' point of view, a~     standardized questionnaire evaluating 1) their QOL as related to the disease of the assisted~     and 2) their expectations concerning the global quality of professional management (care,~     coordination, information...).~      1) their quality of life (QOL) as related to the disease of the assisted and 2) their~     expectations concerning the global quality of professional management (care, coordination,~     information...).~      The original tool validated will complete the palette of those that the investigators are~     developing to evaluate the quality of care of MS patients according to different dedicated~     organizations (formal networks or not, focused on the patients or professionals).~   "
51095|NCT02388321|"~     Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for~     the treatment of moderate to severe pain in pediatric patients in the emergency department.~   "
51096|NCT02388308|"~     Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men~     receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate~     to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as~     the bladder or the rectum. Radiation is delivered in a number of daily treatments which are~     called 'fractions'. The position of the prostate varies each day and during the radiation~     delivery. To accurately aim the radiation the prostate needs to be located before daily~     treatment. Clarity is an ultrasound image guidance system that locates the prostate and~     monitors its position during treatment. Ultrasound does not give a radiation dose, is~     non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is~     implemented the investigators wish to ensure that it can accurately locate and monitor the~     prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive~     markers as part of other trials which are currently recruiting at The Royal Marsden (for~     example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers~     and patients in the PROSPARE trial have received electromagnetic markers). Patients who have~     received or will be receiving markers as part of other studies will be asked to also to take~     part in this study. This means that there will be no additional intervention for patients as~     a result of this study. Clarity will be considered a safe and effective imaging system if~     the mean and standard deviation of the differences between Clarity measurements and marker~     measurements, of prostate position, are less than 1mm. It is possible that markers will~     influence the Clarity measurements. To find out if this happens, the mean and standard~     deviation of Clarity measurements in a group of 24 patients without markers to the group~     with markers will be compared.~      Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for~     prostate motion estimation during treatment (intra-fraction), by comparison with implanted~     marker-based image guidance techniques.~      Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within~     1mm) treatment margins to those that would be employed if fiducial markers based image~     guidance techniques were used.~   "
51097|NCT02388295|"~     AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability,~     randomized trial, in patients with Multiple System Atrophy.~   "
51098|NCT02388282|"~     Dinamic intrinsic PEEP is~   "
51099|NCT02388269|"~     A randomized, sham-controlled, single-centre pilot investigation designed to compare two~     parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in~     subjects with FGIDs.~   "
51100|NCT02388256|"~     Background:~      Patients who undergo laparoscopic surgical resection of colorectal cancer may experience~     various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and~     limitation of daily activities (e.g., walking capacity). There is also a risk of~     post-operative complications and a prolonged hospital stay due to complications. Patients~     who underwent surgical resection may have experienced chronic pain, anxiety/depression, or~     diminished quality of life. The physical, psychological, and functional aspects of patients'~     disorders imply the necessity of multidisciplinary care, including complementary or~     traditional medicines such as acupuncture. This study aims to assess whether acupuncture~     treatment, combined with an enhanced recovery program after surgery in an inpatient care~     setting is effective than only an enhanced recovery program after surgery.~      Objective:~      To assess the effectiveness and safety of acupuncture combined with an enhanced recovery~     program after surgery to reduce postoperative symptoms and improve functional recovery and~     the patients' quality of life.~   "
51101|NCT02388243|"~     The purpose of the two RCT registered here is to determine whether clinicians trained on the~     Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention~     (BI) through the NextGenU.org model of training are able to deliver effective brief~     intervention for risky level of alcohol use. It is one study part of a larger program of~     research.~      The investigators hypothesize that the NextGenU.org model of online training with mentor and~     peer activities is an effective way to train clinicians to deliver the ASSIST-linked brief~     intervention. The investigators hypothesize that eligible participants receiving the brief~     intervention will decrease their alcohol consumption and experienced improved health and~     social outcomes more than those receiving only screening results and written information~     (p<0.05). The investigators hypothesize the level of decrease in alcohol consumption will be~     similar to that of trials conducted in high-income countries (HIC).~   "
51102|NCT02388230|"~     Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe~     breast hardening and shrinkage. These side-effects have been shown to be important factors~     influencing quality of life after breast radiotherapy. It is thought that the likelihood of~     developing these side-effects is related to the presence of underlying genetic differences~     in patients. In order to identify these genetic differences, the severity of side-effects~     needs to be accurately measured. Currently, clinical assessments are conducted by a~     clinician but this is not specific enough to be able to relate development of breast~     shrinkage and hardening to genetic differences. For example, clinical assessment often fails~     to distinguish between hardness due to swelling (known as oedema) and hardness due to~     generalised radiation-induced scarring (known as fibrosis). Ultrasound techniques, however,~     may be able to help quantify and characterise radiotherapy-associated changes in breast~     tissue allowing for better correlation with genetic abnormalities. Once genetic changes can~     be identified, adjustment of breast RT treatments (or add drugs) to help reduce side-effects~     in women at higher genetic risk of side-effects may be possible.~      This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and~     ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and~     firmness with a view to using these techniques to measure the late side-effects of breast RT~     to study the underlying causes of radiotherapy toxicity.~      Principle research question: Can a new ultrasound technique (shear wave elastography)~     measure radiation-induced side-effects in women who have received breast radiotherapy?~   "
51104|NCT02388204|"~     Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by~     addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still~     worsen over time. Postural problems, frequent falls, freezing of gait impairment and other~     locomotion difficulties still remain as important causes of disability and incapacity. Novel~     therapeutics approaches are needed to restore quality of life (QoL).~      This study aims to explore the effects of spinal cord stimulation in locomotion, falls and~     freezing of gait in advanced PD patients.~      Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a~     prospective study for six months.~      Changes in locomotion capacity and freezing of gait rating will be the primary out come.~     Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always~     comparing the status before, one, three and six months after stimulation was initiated. A~     double blind trial will be performed within three months of follow up (high X low frequency~     stimulation).~   "
51105|NCT02388191|"~     The purpose of this study is:~        1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on~          a 0-10cm visual analogue scale compared to placebo (primary outcome).~        2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum~          placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale~          compared to placebo (secondary outcomes).~        3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD~          insertion.~      Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD~     insertion will lead to a reduction in pain scores associated with IUD insertion compared to~     placebo.~   "
51106|NCT02388178|"~     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults~     to evaluate remineralization of early caries lesions.~   "
51107|NCT02388165|"~     The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent~     postoperative Staphylococcus aureus infections in patients who are undergoing elective~     spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing~     elective spinal surgery.~   "
51108|NCT02388152|"~     The purpose of this study is to determine if multiple immunizations with Lu AF20513 is~     tolerable and safe in patients with mild Alzheimer's disease.~   "
51109|NCT02388139|"~     Aims~        -  assessment of renal artery stenosis incidence in consecutive AMI patients included in~          the Romanian National Programme of Primary Percutaneous Revascularisation;~        -  generating a cardio-renal-metabolic profile in patients with renal atherosclerotic~          disease;~        -  creating a local registry (based on European CARDS percutaneous interventional~          registries) which also includes renal, metabolic and vascular data;~        -  reporting long-term follow-up data on major cardiac adverse events (MACE) in the study~          group.~   "
51110|NCT02388126|"~     Prostate cancer has been the most common neoplastic disease in men in Finland over the last~     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate~     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer~     detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography~     (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually~     performed instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided~     biopsies may be false negative and biopsies carry a risk of increase in complications, there~     is an increasing interest in developing more accurate non-invasive imaging modalities.~      This study will enroll 150 men with previous negative biopsies and clinical suspicion of~     prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal~     examination (DRE) or patients in active surveillance due to low risk prostate carcinoma.~     Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla~     (T) magnetic field using surface coils will be used to non-invasively predict the presence~     or absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS~     guided biopsy based on MRI findings will be performed.~   "
51111|NCT02388113|"~     This study will compare two interventions with the same exercise intensities and caloric~     expenditure but with different exercise frequency, on metabolic control and other risk~     factors in individuals with type 2 diabetes.~   "
51112|NCT02388100|"~     This pilot study is planned to validate the comparability of HbA1c results obtained from~     whole blood collection via venous phlebotomy versus a capillary collection of whole blood.~     The participant will self-collect capillary blood into HbA1c prep vials containing a buffer;~     these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS)~     mail. The feasibility of self-collection of these capillary samples by GRADE participants~     will also be evaluated.~   "
51113|NCT02388087|"~     The purpose of the study is to investigate the efficacy of the ROX coupler in treating~     patients with tilt test proven Neurally mediated syncope.~   "
51114|NCT02388074|"~     This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer~     Assay to detect lung cancer cells from deep lung sputum.~   "
51115|NCT02388061|"~     Patients presenting to the emergency department with acute ischemic stroke, who are are~     eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be~     assessed for dual target major vessel occlusion and mismatch to determine their~     eligibility for randomization into the trial. If the patient gives informed consent they~     will be randomised 50:50 using central computerised allocation to intravenous alteplase or~     tenecteplase before all participants undergo intra-arterial clot retrieval. The trial is~     prospective, randomised, open-label, blinded endpoint (PROBE) design.~   "
51116|NCT02388048|"~     A clinical study to evaluate a treatment with two drugs, named Ofatumumab and Ibrutinib, in~     patients with lymphoblastic acute leukemia who have been already treated with other~     therapies.~   "
51117|NCT02388035|"~     Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and~     the changes in the microbiological characteristics reported in the last years are impacting~     the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively~     studied antibiotic for this infection. It is considered to be one of the first choice~     antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous~     cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms~     have been increasingly reported especially to cefotaxime and its effect on the clinical~     outcome in treating SBP.~   "
51121|NCT02387983|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of oral~     posaconazole tablets in Chinese participants at high risk for invasive fungal infections.~     Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or~     myelodysplastic syndromes will be enrolled in the study.~   "
51122|NCT02387970|"~     Dental implants are a widely used treatment option for the replacement of lost teeth due to~     trauma or oral diseases. The original protocol for placement of dental implants in~     edentulous spaces in the maxilla or the mandible was introduced more than thirty years ago~     and called for a two-stage approach, i.e., surgical placement of submerged dental implants~     and subsequent uncovering with abutment connection, prosthesis fabrication and functional~     loading approximately 6 months after. Today, the time between surgery and loading in a~     two-stage protocol has been commonly abbreviated to 3-4 months, while immediate implant~     provisionalization has emerged as a reliable and predictable option in cases of adequate~     osseous support, having similar survival and success rates to the two-step procedure.~     Comparison of histological healing has demonstrated no significant differences in bone to~     implant contact between implants surgically placed according to a two-stage protocol and~     those immediately provisionalized. However, substantial variability was noted among the~     clinical protocols used in the studies carried out so far, and additional well-designed~     randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of~     immediate and early loading protocols.~      The design of dental implants is a subject of continuous improvement, and implant~     manufacturers regularly introduce new products the use of which may result in accelerated~     soft and hard tissue healing, increased initial implant stability, and enhanced esthetic~     outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes~     when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a~     two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®)~     and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an~     internal conical connection. The implant is marketed under the premarket notifications~     K050406 and K073142 (510 (k), Food and Drug Administration).~   "
51123|NCT02387957|"~     To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with~     anti-VEGF therapy.~   "
51124|NCT02387944|"~     The purpose of this study is to assess coagulation and platelet function in children with~     congenital heart disease, measured with a bedside device (thromboelastometry and impedance~     aggregometry).~      The investigators also aim to determine if this device detect post-cardiopulmonary bypass~     clotting derangements and may help to manage bleeding in this population.~   "
51125|NCT02387931|"~     The purpose of this study is to determine whether dietary supplementation with Vitamin D or~     Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with~     endometriosis.~   "
51126|NCT02387918|"~     Tonsillectomy is one of the most frequently performed surgical procedures in children. It~     remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk~     of bleeding, and dehydration due to impaired oral intake. Current medications for POV have~     limited efficacy and may even be associated with potential side-effects. Non-pharmacological~     techniques such as acupuncture has been investigated as alternatives to antiemetics and as~     additional treatment modalities for POV.~   "
51127|NCT02387905|"~     The goal of this clinical research study is to learn whether using body cement on the~     largest part of the vertebra (a procedure called vertebral body cement augmentation) can~     help to prevent a fracture following stereotactic spinal radiosurgery. Researchers also want~     to learn if the procedure can lessen pain and improve quality of life in patients receiving~     this surgery.~   "
51128|NCT02387892|"~     This study is being done to test if adding vitamin D to cheese and yogurt products will help~     children further improve their vitamin D intake. All children will be given a six month~     supply of the milk products. One group will receive yogurt and cheese products already sold~     in stores, while the other group will receive yogurt and cheese products with added vitamin~     D. This will show if milk products with added vitamin D help maintain vitamin D intake and~     child health.~      The investigators are asking children 2 through 8 years old to participate. Children must~     not have any medical conditions that affect their bones or vitamin D levels. They must not~     be taking vitamin D supplements or medications that affect bone. This study will last for 6~     months. The investigators expect 60 children from the Montreal area will participate in this~     study.~      Children will be randomly placed in one of the two study groups. There will be an equal~     number of children in each group. All groups will go through the exact same procedures~     during the study; the only difference between groups will be the amount of vitamin D in the~     milk products they will consume each day. Families will not know which group their child is~     in until the study is complete. Children will continue to drink their regular milk at home~     and the investigators will provide flavoured yogurts and cheese to eat every day for the~     entire 6 month study. Families will be given a fresh supply of the yogurt or cheese products~     every 4 weeks along with instructions.~      There are 3 study meetings for the parent and child to attend which take place at the Mary~     Emily Clinical Nutrition Research Unit. The clinic is located on the Macdonald Campus of~     McGill University in Ste. Anne-de-Bellevue, QC. The first visit is at the start of the~     study, the second is at the end of 3 months and the last visit is at the end of the 6 month~     study.~   "
51129|NCT02387879|"~     CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety~     study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in~     Turkey.~      The study is anticipated to last for approximately 8 years. Recruitment period will continue~     until 500 subjects have commenced the third cycle of treatment with lenalidomide.~   "
51130|NCT02387866|"~     This is a single ascending dose, open-label study that will evaluate the pharmacokinetics~     and safety of the AG-221 compound in normal, healthy volunteer male subjects (both Japanese~     and Caucasian).~   "
51131|NCT02387853|"~     An international, multi-centre, prospective, open-label, non-controlled, single-group,~     4-week trial in adolescent subjects with plaque psoriasis.~   "
51132|NCT02387840|"~     This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in~     children, adolescents and young adults (AYA) with and without brain tumors. This study will~     also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder~     that affects the growth of nervous system cells. Further, it will explore potential ways of~     using of MRF signal measurements in children, adolescents, and young adults with brain~     tumors, including tissue characterization, looking at whether the treatment was effective,~     and finding metastasized tumors of unknown origin (occult tumors). To explore the~     feasibility and potential applications of MRF, this study will recruit up to 80 subjects but~     will stop once 10 subjects have usable data in each of six groups.~   "
51133|NCT02387827|"~     The purpose of this present study is to determine if a daily walking program of 50~     continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on~     body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and~     obese women receiving a low calorie diet for 24 weeks.~   "
51134|NCT02387814|"~     The study involves a single dose of a study drug called abemaciclib taken by mouth. The~     purpose of this study will be to measure how much study drug gets into the blood stream and~     how long the body takes to get rid of it when given to participants with mild, moderate, or~     severe liver impairment compared to healthy participants. In addition, the tolerability of~     the study drug will be evaluated.~      This study will last approximately 3 weeks for each participant, including check-in and~     follow-up.~   "
82786|NCT01973790|"~     The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID~     in European subjects with FD.~   "
51137|NCT02387775|"~     This is a prospective, interventional study aiming to assess the effectiveness of the~     Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest~     patients. In addition, observed adverse events during ECD use, ease-of-use, nurse~     satisfaction and patient outcomes will be examined.~   "
51138|NCT02387762|"~     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and~     efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.~   "
51139|NCT02387749|"~     A debilitating consequence of diabetes mellitus (DM) is neuropathy which globally affects~     between 20 -30% of diabetic patients and up to 50% in other studies. The incidence of~     diabetic neuropathy (DN) is estimated to be up to 45% for type 2 diabetic patients and 59%~     for type 1diabetic patients in USA.(DN) is the most common complication of DM. The risk of~     DN rises with age, duration of DM, and vascular disease. It is Characterized by damages in~     the arms and legs. The pathophysiology of DN is promoted by several risk factors: micro~     vascular disease, neural hypoxia, and hyperglycemia-induced effects At the molecular level,~     the primary cause of diabetic complications is known to be hyperglycemia, which disrupts~     cellular metabolism by the formation of reactive oxygen species (ROS).In the aspect of nerve~     functions, ROS formation increases neuron's susceptibility to damage. In addition,~     hyperglycemia impedes production of angiogenic and neurotrophic growth factors, which are~     necessary for normal function of neurons and glial cells and maintenance of vascular~     structure .The most common presentation of nerve damage due to the effects of hyperglycemia~     is neuropathic pain. (DN)may cause foot deformities such as hammertoes and unnoticed sores~     and infections in the numb areas of the foot. Improperly treated infection frequently~     extends to the bone and requires amputation of the foot.No definitive disease-modifying~     treatments have been to reverse DN. The current treatment focuses on tight glycemic control~     which can reduce potential risk factors for further nerve damage and DN-associated pain~     management. In many studies, deficiency of neurotrophic factors and lack of vascular support~     have been regarded as key factors in the development DN .Mesenchymal stem cells (MSCs) are~     particularly attractive therapeutic agents because of their ability to self-renew,~     differentiate into multi lineage cell types , and locally secrete angiogenic cytokines,~     including basic fibroblast growth factor (bFGF) and vascular endothelial growth factor~     (VEGF) .These factors were reported to prompt neovascularization and have support for neural~     regeneration.MSC transfusion was reported to be a therapeutic agent in the treatment of~     Cardiovascular disease. Similarly, it was plausible that MSCs may also be an effective~     therapeutic agent for the DN treatment through the paracrine effects of bFGF (Shibata et~     al., 2008) and VEGF and their potential to differentiate into neural cells such as~     astrocytes, oligodendrocytes , and Schwann cells.The adherent nature of MSCs makes them easy~     to expand in culture and an attractive candidate to use in cell therapy. Also, MSCs are~     particularly attractive therapeutic agents because of their ability to self-renew,~     differentiate into multi lineage cell types, and locally secrete angiogenic cytokines,~     including (bFGF) and VEGF. Therefore, cell therapy has recently emerged as an attractive~     therapeutic strategy to meet the needs of both neurotrophic and vascular deficiencies of~     DN.In electrodiagnostic studies, nerve conduction velocity and magnitude are measured by~     electrically stimulating nerves. Proper diagnosis of DN depends on the pattern of sensory~     loss, reflex test, electrodiagnostic studies, and imaging~   "
51140|NCT02387736|"~     Standard one-year dialectical behaviour therapy (DBT), which has four components, is an~     effective treatment for people with borderline personality disorder. However, such DBT~     programs are in short supply and costly, resulting in long wait lists. In practice, DBT is~     often reduced in length or intensity. This study will determine whether shorter DBT~     treatment is clinically effective and cost-effective. In total, 240 self-harming BPD~     patients will be randomly assigned to receive either 1 year or 6 months of DBT, with~     follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care~     and general psychological functioning will be examined.~   "
51141|NCT02387723|"~     The present aim is to perform at small clinical safety trial in heart failure patients with~     allogeneic adipose tissue derived mesenchymal stem cells.~   "
51142|NCT02387710|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep~     (called slow wave sleep), potentially via an increase in the stimulus required to arouse~     from sleep. Here the investigators test the idea that the medication called tiagabine~     improves slow wave sleep and reduces OSA severity. The investigators will also test whether~     tiagabine raises the arousal threshold (more negative esophageal pressure), and whether~     detailed OSA phenotyping characteristics can predict the improvement in OSA severity with~     this intervention.~   "
51143|NCT02387697|"~     The purpose of this study is to assess the efficacy and safety of implanting an Edwards~     Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein)~     on clinical variables, exercise tolerance and well being in patients with severe tricuspid~     regurgitation and signs of right heart failure.~   "
51144|NCT02387684|"~     The most important method to slow down and stop the liver disease progression in patients~     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral~     response during treatment or obtain sustained viral response after treatment. The aim of the~     therapy with interferon is make patients obtain immune control to HBV defined as sustained~     viral response after treatment, however, most patients can't get this target after 48 weeks~     of interferon treatment, and some patients need extended treatment in clinical practice to~     enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In~     this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic~     hepatitis B patients will be evaluated.~   "
51145|NCT02387671|"~     The long-term goal of this research is to develop, evaluate and implement effective mHealth~     technology interventions that improve cancer management outcomes by changing lifestyle~     behaviors among urban health- disparity facing populations. To accomplish this goal, the~     investigators will need to determine the feasibility and preliminary efficacy of an~     intervention in which breast cancer survivors receive counseling about lifestyle behaviors~     (weight, nutrition, and physical activity) from a health counselor trained in~     evidenced-based behavioral counseling methods.~   "
51146|NCT02387658|"~     1. To perform an observational analysis to determine if mean translesional gradient~          measurements (TLG) are associated with differences in clinical outcomes in patients~          with femoropopliteal arterial disease and claudication.~        2. Hypothesis: Patients stratified by a residual translesional gradient </= 11 mmHg after~          peripheral revascularization or angiography alone will have better clinical outcomes~          than patients with TLG > 11 mmHg as assessed by six minute walk (6MW), walking~          impairment questionnaire scores (WIQ), ankle brachial index and need for repeat~          procedure at 6 months.~   "
51147|NCT02387645|"~     The current pilot study aims at answering the scientific question, whether exfoliated cells~     from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity~     and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based~     cervical cytology. If this turns out to be the case, earlier detection, particularly of type~     II EC should be possible.~   "
51148|NCT02387632|"~     Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for~     children with respiratory failure. Despite its extensive use in pediatric and adult~     population, the exact mechanism of work of HHFNC is not fully explained.The objective of the~     investigators' research project is to determine the relationship between the amount of~     airway pressure that can be delivered at specific flow levels of HHFNC. This information~     will allow the investigators to use HHFNC in a much more informed and safe manner.~   "
51149|NCT02387619|"~     A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic~     drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers~   "
51150|NCT02387606|"~     The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ~     53718678 compared to placebo in healthy adult participants infected through inoculation with~     respiratory syncytial virus (RSV)-A Memphis 37b virus.~   "
51151|NCT02387593|"~     Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The~     cumulative risk of developing CRC is about 6% lifelong.~      The benefit of screening colonoscopy depends on the detection and removal of all adenomas,~     however, some of these may be difficult to detect.~      The endocuff (EC) is a polymer sleeve which joins the tip of the colonoscope to improve~     the image viewing of the mucosa during colonoscopy procedure.~      There is insufficient evidence of the usefulness of endocuf~   "
51152|NCT02387580|"~     This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy~     male subjects and female subjects of non-childbearing potential.~   "
51153|NCT02387567|"~     The purpose of this study is to investigate the effects of a treatment involving the~     application of lidocaine injected on the low back area for pain control. The study will~     compare this form of treatment with other options such as physical exercises or pain killer~     medication, different measurements are going to be used to quantify the response to each of~     these treatments.~   "
51156|NCT02387528|"~     High demands put on workers nowadays have contributed for an increase on the vulnerability~     and the stress levels, with severe consequences for the health (Sandim, 2008). One of the~     main health conditions today is the Burnout Syndrome - or professional exhaustion (Salanova~     and Llorens, 2008), with harmful consequences for individuals and organizations. The level~     of dedication to the tasks in which the frustrations are faced more strongly can determine~     what type of burnout would be developed ( frenetic, under-challenged or worn-out),~     affecting the health condition. In late 1970s, mindfulness began to be studied as a~     behavioral intervention in mental health. Current evidence suggests that the state / mental~     trait mindfulness is positively associated with a variety of mental health indicators. The~     potential applicability of mindfulness in health services is great. Besides the effects for~     patients, health professionals also can have benefits. The consensus is that a greater~     number of mental health interventions need to be evaluated and implemented and it is~     possible that mindfulness can fit this need as a new technology in health care. There is a~     gap in the literature on the relationship of different clinical types of burnout and its~     association with different psychological constructs related to health, particularly in~     relation to the mental state of mindfulness and, in particular , addressing health~     professionals. Better understand this association will enable the improvement of existing~     and development of new interventions, geared to the specific needs of the population of~     health professionals, especially for professionals of Primary Health Care (PHC) , the object~     of this study. Thus, the general objective of this study is to assess the effect of a~     mindfulness-based intervention for primary health care professionals in the city of Porto~     Alegre, evaluating the behavior of a questionnaire for clinical subtypes of burnout (BCSQ~     -36), other variables of psychological well -being, depression and anxiety symptons,~     activity and sleep patterns, measuring before and after the intervention, from a randomized~     controlled trial.~   "
51157|NCT02387515|"~     This clinical pilot trial will investigate the effects of technology-supported exercise~     therapy for chronic non-specific low back pain. Patients will follow an intensive~     rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that~     is supported by technology. The technological system consists out of motion tracking sensors~     that register the movements and position of the lumbar spine.~   "
51158|NCT02387502|"~     Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three~     axes are not aligned, intubation becomes difficult. In the researchers' study, the~     investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This~     neck collar renders intubation difficult not only by restricting neck movement, but also~     reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and~     Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.~   "
51159|NCT02387489|"~     The purpose of the study is to examine the comparative effectiveness of a computerized brief~     intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana,~     alcohol, and sex risk behaviors in adolescents receiving services in school-based health~     centers.~   "
51160|NCT02387476|"~     This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to~     characterize the clinical performance during a single night of therapy with a FRESCA mask~     compared with a single night of therapy with their existing nasal Continuous Positive Airway~     Pressure (CPAP) mask.~   "
51161|NCT02387463|"~     The most important method to slow down and stop the liver disease progression in patients~     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral~     response during treatment or obtain sustained viral response after treatment. The aim of the~     therapy with interferon is make patients obtain immune control to HBV, in clinical practice,~     it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg~     positive patients. However, those targets can't be get in most patients by 48 weeks of~     interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg~     seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of~     interferon in HBeAg positive chronic hepatitis B patients will be evaluated.~   "
51162|NCT02387450|"~     Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of~     the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil~     in term of morbi-mortality in patients with arterial claudication on a multicenter~     prospective double blind study.~   "
51163|NCT02387437|"~     Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which~     pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one~     of the important therapy for improvement of this phenomenon. The previous research focuses~     on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS.~     Seldom investigators try to find the intuitive change of heterogeneity when recruitment~     maneuver is implemented. In this study, the investigators compare three recruitment~     maneuvers on the lung heterogeneity of ARDS.~   "
51164|NCT02387424|"~     Pregnant women with histories of depression are at high risk of depressive~     relapse/recurrence during the perinatal period, and options for relapse/recurrence~     prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among~     general populations but has not been studied among at risk pregnant women.~      This study is the second phase of a multi-phase project adapting MBCT for perinatal women~     (MBCT-PD).~   "
51165|NCT02387411|"~     Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac~     deterioration as well as peripheral vascular and muscular abnormalities, resulting finally~     to reduced exercise tolerance, quality of life and mortality rates. Exercise training is a~     major component of rehabilitation / secondary prevention interventions, inducing significant~     beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity~     and quality of life, while a positive impact on hospitalization and mortality reduction~     should not be also excluded. There has been growing interest in the characteristics and~     modalities of exercise training able to induce optimal benefits. High intensity and interval~     mode have been shown to induce greater benefits than moderate intensity and continuous mode~     regimes. Additionally, there has been sound rationale for the inclusion of strength~     training, which has been also shown able to yield benefits in terms of exercise capacity and~     quality of life. However, there haven't been much data on the so called combined regimes,~     which include both aerobic exercise and strength training. This study aims at investigating~     the effects of combined high-intensity interval and strength training compared to~     high-intensity interval exercise alone in CHF.~   "
51178|NCT02387242|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood~     Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose~     of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).~   "
51179|NCT02387229|"~     This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the~     efficacy and safety of rivaroxaban as compared to acetylsalicylic acid in reducing stroke,~     transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF~     and with low risk of stroke.~   "
51166|NCT02387398|"~     This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and~     efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac~     arrest patients without ST segment elevation. Safety will be assessed by evaluating the~     association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension,~     acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be~     assessed by a composite endpoint of improved left ventricular regional and global function~     (both regional wall motion analysis and left ventricular ejection fraction) as measured by~     echocardiography prior to hospital discharge and favourable neurological function (Cerebral~     Performance Categories 1 or 2) at discharge.~   "
51167|NCT02387385|"~     Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral~     blood flow and oxygen supply to the foetal brain at the time of birth. Every year,~     approximately one million babies die from neonatal encephalopathy in low and middle-income~     countries and a quarter of these deaths occur in India.~      In the past decade, a number of clinical trials in high-income countries has shown that~     cooling therapy along with optimal neonatal intensive care reduces death and neurodisability~     after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after~     neonatal encephalopathy in all high income countries, including the UK.~      Although the burden of neonatal encephalopathy is far higher in low and middle-income~     countries, the safety and efficacy data on cooling therapy from high income cooling trials~     cannot be extrapolated to these settings, due to the difference in population co-morbidities~     and sub-optimal neonatal intensive care.~      The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6~     hours of birth and continued for 72 hours reduces death or neurodisability at 18 months~     after neonatal encephalopathy in public sector neonatal units in India.~      A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from~     the participating centres in India over an 18 to 24 month period. The babies will be~     randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved~     using an approved cooling device (Tecotherm) that is already in clinical use in the UK and~     in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the~     brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary~     outcome measure is death or moderate/severe neurodisability at 18 months.~   "
51168|NCT02387372|"~     The purpose of this study is to evaluate the pharmacokinetics and lung penetration of~     intravenous Ceftolozane/tazobactam in critically ill participants.~   "
51169|NCT02387359|"~     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,~     parallel-group clinical trial with 12 weeks of study drug therapy.~   "
51170|NCT02387346|"~     The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait~     impairments and postural instability has been made evident. The current study will use a~     Magstim Rapid 2 to deliver rTMS with the aim of modulating the activity in the~     vermal/paravermal region of the cerebellum, and consequently the cerebello-thalamo-cortical~     pathway. Analysis of the effects of an acute session of stimulation will be made to~     determine the therapeutic potential of the protocol. Motor symptom improvement will be~     assessed immediately following stimulation to detect motor symptom improvement up to one~     hour following stimulation, providing insight into the effectiveness of the protocol to~     produce benefits which outlast the period of stimulation.~      Participants will each receive one session of stimulation in the ON state of medication. A~     pre-assessment will be performed before beginning the session and a post-assessment will be~     performed immediately following stimulation. There will be two groups, which will both~     undergo the exact same protocol, however one group will receive real stimulation, and one~     group will receive sham stimulation.~   "
51171|NCT02387333|"~     The aim of this clinical trial is to investigate the safety and efficacy of prophylactic~     mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a~     randomized controlled fashion.~   "
51172|NCT02387320|"~     This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to~     determine the effectiveness of a self-care toolkit on specific symptoms associated with~     surgery as compared to a standard care group.~   "
51173|NCT02387307|"~     This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via~     subcutaneous injection for 21 days, with 1 week of washout per cycle).~   "
51174|NCT02387294|"~     Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent,~     seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children~     and Adolescents.~   "
51175|NCT02387281|"~     Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD)~     and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30~     seconds) episode of absence or a greatly reduced forward movement of the feet despite~     intention to walk. It typically occurs when patients initiate gait (so-called start~     hesitation) and when attempting to turn. It is a leading cause of falls and often results~     in a wheelchair-dependent state. FOG greatly interferes with activities of daily living,~     causes social isolation and poor quality of life.~      FOG is one of the least understood features of PD. It possibly may develop independent of~     the other motor features of the disease, and be caused by specific pathological changes in~     the brain. Previous studies on FOG have shown conflicting information and have not lead to~     clear understanding of the pathophysiology. One key reason for this is that there appears to~     be multiple subtypes which have rarely been taken into account.~      The purpose of this study is to show that different types of FOG exist and to see if there~     is a connection to cognitive differences or gait patterns.~   "
51176|NCT02387268|"~     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a~     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.~   "
51177|NCT02387255|"~     The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to~     determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE~     is a more sensitive and superior method of determining the risk for rupture of AAA based on~     stiffness estimates when compared to the current, crude method of assessing risk based on~     measurement of the diameter of the aneurysm. The investigators will also validate the~     stiffness estimates against gold standard i.e. mechanical testing and histopathology only~     AAA patients undergoing AAA surgery.~   "
83573|NCT01963468|"~     The purpose of this study is to evaluate the effects of early intervention on language~     skills for children with hearing loss.~   "
51182|NCT02387190|"~     Pulmonary dysfunction presented in patients with heart failure is observed as a decrease of~     maximal aerobic capacity compared to healthy people. Lung function deterioration manifests,~     in the presence of muscle fatigue and dyspnea on exertion, loss of functional capacity, and~     activities limitation of daily living. Those manifestation influence the perception of~     quality of life of patients1.~      Patients with heart failure need to develop changes in lifestyle and daily activities aiming~     to maintain clinical control and prevent the onset of complications and disabilities. If~     these changes are not often performed, they might carry bigger burden to for the individual~     and their family and for the healthcare system due to increasing of morbidity and mortality~     between those patients2.~      Systematic reviews conducted in developed countries (USA3, UK4 and Canada5) and developing~     countries (Colombia6) have shown that telehealth can produce positive effects in individuals~     with chronic diseases as heart failure. This kind of intervention seems to be effective in~     preventing hospitalizations and non-elective emergency visits.~      In Brazil, telenursing is still a non-standardized and non-diffused intervention. In this~     perspective, telenursing represents soft new tools to provide quality care. It certainly~     allows the orientation and training of patients, the permanence of them at home, reduces~     unnecessary hospitalization. Additionally, this intervention, allows the management of~     nursing time and strengthens their professional autonomy7.~      The principal aim of this study is to describe the protocol to be used in MRE study. The~     objective of MRE trial is to test the hypothesis that telenursing contributes to the~     improvement in lung function over the medium term, in patients with heart failure under~     continuous education.~   "
51183|NCT02387177|"~     The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use~     with adolescents, and to test its feasibility, acceptability, and preliminary effect in~     improving quality of life, and in decreasing stress and psychological distress.~   "
51184|NCT02387164|"~     The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD~     (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process~     leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell~     autoimmunity as indicated by positive islet autoantibodies.~   "
51185|NCT02387151|"~     This study will test whether selected allogeneic bone marrow derived MSCs are safe by~     assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12~     months.~   "
51186|NCT02387138|"~     This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities~     (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule)~     and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).~   "
51187|NCT02387125|"~     This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered~     LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305~     [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian~     cancer, or non-small cell lung cancer that express NY-ESO-1.~      CMB305 is a novel in vivo approach designed to stimulate the body's immune system to fight~     the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein.~     LV305 will be given in a prime-boost approach with G305 to induce a synergistic~     immunotherapeutic response.~   "
51188|NCT02387112|"~     The aim of the study is to assess whether, in patients who are listed for cardiac~     transplantation in transplantable (T) status, early implantation of a left ventricular~     assist device is superior to the current therapeutic strategy of medical heart failure~     therapy and assist device implantation only after serious deterioration of the patient's~     condition.~   "
51189|NCT02387099|"~     The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition~     to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor;~      Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis~     especially during the first 12 weeks of treatment leading cause for treatment~     discontinuation not related to tumor progression;~      GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment~     in combination with paclitaxel for patients without response to 4 cycles~     epirubicin/cyclophosphamide with/without bevacizumab.~      A dose-escalation schema was successfully used to improve tolerability of everolimus~     together with the cytotoxic Agent.~      Everolimus plus exemestane has improved the prognosis of metastatic breast cancer~     significantly. Desiree-study aims to improve the tolerability, which is necessary in order~     to achieve an adequate dose intensity for the patients in Routine care.~   "
51190|NCT02387086|"~     The purpose of this study is to determine whether thalidomide can improve the effectiveness~     of the gefitinib in NSCLC patients with EGFR mutations.~   "
51191|NCT02387073|"~     Recently the importance of electrical PRO system is increased for the accuracy, convenience,~     and efficiency for both patients and physicians. For the evaluation of quality of life,~     various self-reported questionnaires is filled-out by the patient, mostly in front of~     outpatient clinic, and doctor usually take times to calculate the score. If there is~     electrical PRO which is available with mobile device, the efficacy of clinic would be~     improved. The investigators developed such a system and applied the system for patients with~     spinal disease. The investigators assessed the effectiveness of application of~     electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in~     paper version.~   "
51192|NCT02387060|"~     Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly~     effective, their use is not without problems. One is the increasing requirement of these~     address the same nociceptive stimulus.~      Opioid induced hyperalgesia could be an explanation studies in animal models. Through~     mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and~     changes in intracellular calcium regulation involved.~      The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose~     a model study in patients undergoing cesarean section to study the secondary hyperalgesia~     induced based on the study of nociceptive thresholds with two methods opioids: Von Frey~     filaments and digital algometer.~      If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an~     increase in sensitivity will occur. This increase can be measured by von Frey filaments,~     expressed in increased requirement clinically opioids.~   "
51274|NCT02385994|"~     The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten~     dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of~     melasma and lentigines on the face in Asian skin.~   "
51193|NCT02387047|"~     The aim of this study is to determine the validity of a self-questionnaire detecting seniors~     phobia of falling living at home. A prospective monocentric observational study compares in~     a blind way the presence of Diagnostic and Statistical Manual of Mental Disorders fourth~     edition (DSM-IV) criteria for specific phobia, considered as the gold standard to the score~     obtained at the detecting questionnaire for ≥70 years old seniors suspected of phobia of~     falling and attending geriatric day hospital at the Bretonneau hospital (APHP, Paris).~   "
51194|NCT02387034|"~     The purpose of this study is to determine whether an intervention with Physical activity on~     prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would~     result in effects on physical activity level, physical capacity and quality on life.~      The hypothesis is that patients with osteoarthritis in hip or knee will increase their level~     of physical activity significantly more with a PAP intervention compared to patients who~     only get general advice about physical activity.~   "
51195|NCT02387021|"~     The purpose of the study is to determine whether the association of sciatic nerve block to~     continuous adductor canal block is effective in the treatment of total knee arthroplasty~     post operative pain .~   "
51196|NCT02387008|"~     Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient~     dimension to permit dental implant placement. While a wide variety of bone graft and barrier~     membrane products are commercially available, limited evidence exists supporting the use of~     one technique over another. The purpose of this study is to radiographically define the~     dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR®~     (Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of~     inflammation, infection, or other wound healing complications.~      Participants: A total of 60 patients requiring bone augmentation of a single bound~     edentulous site prior to dental implant placement will be selected for this study. This is a~     multicenter study with 30 patients receiving treatment at each study site.~      Procedures (methods): Patients will be randomly allocated to receive horizontal bone~     augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA),~     synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. CBCT imaging will~     be obtained at baseline and 6 months post-operatively to assess dimensional alveolar ridge~     changes. Additionally, post-operative appointments at 1, 2, and 4 weeks post-grafting will~     be completed to assess the presence of inflammation, infection, wound dehiscence, or~     membrane exposure.~   "
51197|NCT02386995|"~     The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring~     such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological~     conditions such as Parkinson's disease by comparing these monitoring with standard clinical~     monitoring like heart rate, blood pressure and respiratory rate.~   "
51198|NCT02386982|"~     This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and~     tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.~   "
51199|NCT02386969|"~     The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for~     several years. The aim of the study is to assess, in a rigorous scientific protocol,~     analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic~     painful subjects. The crossover study is randomized, double blinded and controlled (sham~     rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.~   "
51200|NCT02386956|"~     Randomized clinical trial to evaluate the elongation of the hamstrings after making~     different types of stretching. One group receives a stretch of global postural reeducation~     (RPG), another group receives a mobilization of sciatic nerve, and a third group received a~     placebo treatment. The evaluation of these treatments are done previously, immediately after~     and 20 min later. The test used to evaluate elongation are the Sit and Reach and active knee~     extension (AKE test).~   "
51201|NCT02386943|"~     The objective of this study is to explore the effects of two DPP-4 inhibitors(Sitagliptin,~     Saxagliptin) on β- and α-cell function, as well as the incretin effect.~   "
51202|NCT02386930|"~     The primary purpose of this study is to develop a behavioral lifestyle intervention and~     evaluate its effectiveness in improving the glycemic control in patients with type 2~     diabetes in real life setting. This is because ambiguity still exists on the effectiveness~     of behavioral lifestyle interventions in routine clinical practice despite of the efficacy~     of large randomized controlled trials, suggesting the need for more research in this area.~   "
51203|NCT02386917|"~     Drug bioavailability and disposition vary according to body weight and weight loss after~     bariatric surgery. This study evaluates the impact of body weight and weight loss on the~     pharmacokinetics of various probe drugs, and compares these effects in three groups of~     patients receiving either a gall bladder operation, gastric bypass or a very low calorie~     diet.~   "
51204|NCT02386904|"~     The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for~     bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the~     safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy~   "
51214|NCT02386774|"~     In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed~     with two reflectance microscopes attached on a mounting with limited movement along the XYZ~     axes. Consequently, ocular diseases in the central area have been described (mostly cornea~     and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a~     multifluorescent one) present significant innovations that the investigators want to assess~     in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract~     diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter~     objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva,~     eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM~     allows the use of a wide range of fluorescent markers liable to increase the specificity of~     the diagnosis by revealing staining patterns corresponding to a specific disease and not to~     others (part 2 of the study)~   "
51215|NCT02386761|"~     A phase I randomised, double-blind, placebo-controlled study of single and repeated~     ascending doses in healthy volunteers to investigate the safety, tolerability and~     pharmacokinetics of inhaled chf 6001.~   "
51275|NCT02385981|"~     H-1: tcpO2U2 > tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1~   "
53067|NCT02362503|"~     The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)~     is effective in the treatment of heavily treatment experienced HIV-1 patients with~     multi-drug resistance.~   "
51205|NCT02386891|"~     Based on preliminary data and previous studies, the investigators hypothesize that the~     ambient temperature experienced by an individual influences his or her food intake in males~     and females aged 19 to 30. Specifically, exposure to temperatures above the thermoneutral~     zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers~     will execute a randomized control trial specifically testing thermal exposure and its effect~     on an individual's food consumption. Participants will receive and wear a t-shirt. They will~     have a thermal image taken of the inner canthus of their eye and middle finger nail bed,~     representing a baseline of core and peripheral temperatures, respectively. They will be~     randomized to either a colder environment (65°F) or a warmer environment (75°F) under the~     artifice of monitoring routine office work with abnormal temperature conditions. Their~     knowledge of the experiment will be limited until the end. They will experience this~     temperature while filling out paperwork and performing basic office tasks. After one hour,~     another thermal image will be taken. Each participant will be presented with a large, Mellow~     Mushroom cheese pizza and directed to eat at their leisure and subsequently finish the~     office tasks over the next hour. The participants will then be debriefed on the parameters~     of the experiment and body measurements will be taken at the end so as to prevent bias of~     the subject by limiting their food intake. The investigators will quantify energy intake by~     weighing remaining food and comparing to known caloric content by weight from bomb~     calorimetry tests. The infrared thermal images will determine whether the temperatures~     experienced were extreme enough to initiate a change in thermoregulation.~   "
51206|NCT02386878|"~     The PHE study is a two-year longitudinal study evaluating two interventions for reducing~     depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of~     South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV~     infection relative to their peers; however, evidence on how best to address HIV prevention~     and psychological health among this population is lacking. This study examines the efficacy~     of both a psychological and behavioral intervention, alone and in combination, on related~     outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a~     community-randomized controlled trial with a factorial design, a cost-effectiveness~     analysis, and a qualitative component. At baseline data collection in January 2012, more~     than 1000 adolescents and their caregivers were interviewed; these participants were invited~     to take part in two more survey rounds designed to examine both the immediate and long term~     effects of the interventions. Support for this research was provided by USAID under Grant~     No. GHH-I-00-007-00069-00.~   "
51207|NCT02386865|"~     Although several prognostic models have been developed to predict outcome for patients with~     severe traumatic brain injury (TBI), currently no study describes the impact of respiratory~     failure during Emergency Department treatment on mortality in a population of elderly~     patients. The purpose of the present study was to evaluate factors predicting poor outcome~     with special emphasis on the impact of respiratory failure on mortality in elderly patients~     with isolated severe TBI.~      All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this~     Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were~     identified from the trauma registry. Stepwise logistic regression analysis was used to~     identify risk factors for a poor prognosis and outcome.~      The logistic regression found the following variables influencing the mortality: respiratory~     failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score~     (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for~     patients with a midline shift >15 mm.~      The present study predicts a strong correlation between respiratory failure, pathological~     pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly~     patients sustaining an isolated severe TBI.~   "
51208|NCT02386852|"~     There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive~     performance, however, very little is known about the mechanisms associated with such~     improvement. Here, we tested whether cardiovascular reactivity to a task is associated with~     cognitive improvement.~   "
51209|NCT02386839|"~     This observational study will compare safety and efficacy treatment outcomes in infants that~     received study drug treatment with infants that received standard neonatal care in Study~     ROPP-2008-01 (NCT01096784).~   "
51210|NCT02386826|"~     The purpose of this study is to determine whether the combination of two agents, INC280 and~     bevacizumab, are safe and effective when administered to patients who have received prior~     therapy for Glioblastoma Multiforme (GBM), metastatic colorectal cancer (mCRC), or~     metastatic renal cell carcinoma (mRCC) and who have progressed after therapy.~   "
51211|NCT02386813|"~     This study is to explore risk factors for poor progression-free survival (PFS) and overall~     survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with~     non-anthracycline based treatment.~   "
51212|NCT02386800|"~     This roll-over protocol allows patients who are still receiving clinical benefit to continue~     to be treated from multiple protocols in one program spanning multiple indications during~     the completion of the parent study/(ies). The population for the roll-over study should be~     consistent with the population defined in the program parent study/(ies). The primary~     eligibility criteria for a patient to enter the roll-over protocol is the participation and~     completion of a Novartis OGD&GMA/Incyte study with ruxolitinib. Efficacy parameters would~     not be measured; however safety data will be collected.~      Patients who have completed a prior study with ruxolitinib and who are assessed by the~     Investigator to continue to benefit from ongoing treatment with the investigational~     ruxolitinib will be eligible.~   "
51213|NCT02386787|"~     Aspiration of gastric content is a rare but serious complication of anesthesia. In this~     context, preoperative fasting for elective surgery is well defined. In an emergency~     situation, international guidelines recommend rapid sequence of anesthesia to reduce the~     risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic~     procedure even if a preoperative fasting has been observed due to uncertainty of gastric~     emptying related to stress or painful condition. The choice of anesthesia induction~     technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool~     that can provide reliable quantitative information about the volume of gastric content.~   "
51590|NCT02381873|"~     This exploratory study will quantify and describe patient-reported and objective measures of~     sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities~     and levels of habitual physical activity prior to and around the time of surgery.~   "
51216|NCT02386748|"~     The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the~     recovery of intestinal movement after cesarean section.~      All women undergoing elective cesarean section in King Faisal military hospital will be~     candidate for this trial after full explanation of the trial and informed consent to be~     taken from the women. Exclusion criteria will include emergency cesarean section, multifetal~     pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa~     and/or accreta), past history of bowel injury or operation, any complications that will~     increase operative duration such as uterine artery injury or uterine extension.~      450 consented women for being enrolled in this clinical trial and candidates for elective~     cesarean section will be divided into 3 groups:~        -  Group A, 150 women will receive sugarless gum after their operating room discharge by 2~          hours for at least half an hour at two hours interval.~        -  Group B, 150 women will receive the traditional management of starting oral fluids~          after operating room discharge by 6 hours and hearing intestinal sounds on second day~          before initiating full regular diet.~        -  Group C, 150 women as control group, they will not receive neither gum nor oral fluids.~          They will be in intravenous fluid.~      All demographic data of these women, indication of operation, operation time, type of~     anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.~   "
51217|NCT02386735|"~     Background~      Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative~     treatment. In Switzerland estimated 5-7% of the total population are suffering from this~     chronic disease. According to current guidelines corticosteroids are part of treatment of~     acute exacerbations in COPD patients. Several studies suggest that corticosteroids~     accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of~     hospitalization, reduce treatment failure rate and improve clinical outcome. The additional~     therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The~     investigators recently published a hospital-based study showing that in patients presenting~     to emergency departments with acute exacerbation of COPD, a short five day treatment with~     systemic steroids was not inferior to a conventional 14 day treatment with regard to~     re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the~     investigators knowledge no data is available about the minimal necessary corticosteroid dose~     in an outpatient treatment setting so far.~      Aim~      The primary aim of this study is to investigate in an outpatient setting, whether a three~     day treatment with orally administered systemic corticosteroids is non-inferior to a five~     day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be~     reduced by shorter therapy.~      Hypothesis~      The investigators postulate, that in an outpatient setting, where generally less severe~     exacerbations are being treated, a three day treatment duration of systemic corticosteroids~     should be non-inferior to a five day treatment duration with regard to treatment benefits~     but decrease cumulative corticosteroid exposure.~      Design and Setting~      This study is going to be performed as a prospective, randomized, double-blind,~     placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be~     performed as block randomization with a 1:1 allocation. The investigators are going to~     recruit GPs in northwestern and central Switzerland.~      Methods~      The investigators are going to include patients presenting to GP's with acute exacerbation~     of COPD. When matching the investigators eligibility criteria and written informed consent~     is given, patients included in the study are receiving systemic corticosteroid treatment~     (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days~     (interventional arm) followed by two days of placebo for the interventional group.~     Pre-randomized, identically looking, numbered blisters are given to all patients included in~     the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is~     given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as~     well as patients presenting with all three of the following symptoms: change of baseline~     dyspnea, change of sputum quantity and sputum purulence. Further initial treatment and~     steroid treatment after inclusion is determined and documented by the GP. Patients will~     undergo follow-up visits at day three and seven by their GP as well as follow-up phone calls~     executed by the study center at day 30, 90 and 180.~   "
51218|NCT02386722|"~     Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the~     important progresses achieved in treatments, the majority of affected patients suffer from~     severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for~     uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor~     following of the prescribed treatment plan is observed, which is called non-adherence.~      The primary aim of this study will therefore be to measure medication adherence in patients~     with chronic obstructive lung diseases, and to investigate the impact of an audio reminder~     on disease outcomes and quality of life.~      The investigators hypotheses will be that an adherence reminder, improve medication~     adherence and that a good medication adherence elongate the time to next exacerbation in~     patients with chronic obstructive lung diseases.~      A prospective single-blind randomized controlled study is planned, where the investigators~     are going to analyse the adherence over a period of six months of in- and outpatients, who~     have experienced at least one exacerbation during the last year. The adherence of~     intervention- and control group will be measured by specific electronic data capture devices~     which can save each actuation with date and time. Patients assigned to the intervention~     group will be reminded for the inhalation by an audio reminder and will receive support~     calls if medication will not be taken as prescribed or if rescue medication will be used too~     often. In contrast, the control group, will not be reminded and will not receive any calls,~     if do not comply with the prescribed medication schedule or if they use their rescue~     medication too frequently.~      During study period, participants will be assessed every two months. Each assessment will~     include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon~     monoxide. Moreover participants will demonstrate their inhalation techniques by using~     placebo devices and fill out questionnaires regarding quality of life.~      Statistical significance will be acquired if a p value of less than 0.05 is attained. Time~     to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional~     hazard model. Results will be reported as HR (hazard ratio) with corresponding 95%~     confidence interval (CI) and p-value.~      Time to next exacerbation is subject to the investigators power calculation. A previous~     study has shown that 30% of COPD patients are readmitted again within six month because of~     an exacerbation. The investigators expect that 12% of patients in the intervention group~     will have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample~     size of 70 subjects for each study group, there is a power of 80% to detect a HR of 0.36~     based on a one-tailed test. Additional 14 subjects (7 for each study group) have been added~     to account for drop outs. Therefore, 154 subjects will be investigated in this study.~   "
51219|NCT02386709|"~     Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The~     aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete~     Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The~     rate of pCR is about 20%, although there are important variations according to tumor subtype~     and the type of treatment. The objective of the new therapeutic strategies is to increase~     this response rate.~      The purpose of this study is to investigate the possibility of early evaluation of~     neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron~     emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.~   "
51220|NCT02386696|"~     Recently, ultrasound artifacts mimicking lung sliding have been described in absence of the~     visceral pleura, in a group of patients who underwent pneumonectomy. In these patients, lung~     sliding was clearly absent during mechanical ventilation in the operated hemithorax. During~     spontaneous breathing, although of lower intensity compared to the unoperated hemithorax,~     some artifacts mimicking lung sliding and seashore sign were found during each deep~     spontaneous breath. These findings have led to the hypothesis that these artifacts may be~     due to the contraction of the intercostal muscles.~      The objective of the present study is to reproduce such artifacts during contraction of the~     inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers): in~     this condition each subject is not ventilating and the two pleural layers are not sliding~     one over each other.~   "
51221|NCT02386683|"~     The purpose of this study is to explore the effectiveness of lung-protective ventilation~     during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome,~     compared with traditional ventilation.~   "
51222|NCT02386670|"~     This 5-year randomized controlled trial will compare the efficacy of non-invasive brain~     stimulation (trans-cranial Direct Current Stimulation - tDCS) combined with cognitive~     remediation (CR) versus sham (placebo) tDCS combined with sham (placebo) CR in slowing~     down cognitive decline and preventing Alzheimer's Dementia in older persons with mild~     cognitive impairment or major depressive disorder with or without mild cognitive impairment.~   "
51223|NCT02386657|"~     Sickle Cell Disease is a serious disease that is life-threatening for patients being~     homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann~     hospital currently regularly treats about 70 homozygous adult patients and this number is in~     constant augmentation. The age average of the patients is below 30. The hospital developed a~     close collaboration with the Queen Fabiola Kids University Hospital to optimize the~     transition of young sickle cell patients from the pediatric to the adult network.~      The emergency care of sickle cell patients remains a source of worry. Even with a correct~     treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle~     cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable~     and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The~     crisis are more frequent with poor compliance to the treatments.~      There are several obstacles to the rapid and optimal management of these patients:~        -  fear of causing addiction to heavy pain releaf products (high dosis of morphine)~        -  lack of biological parameters for the determination of the crisis severity.~      The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was~     recently stressed while activation of the coagulation, translated by the elevation of~     various parameters including the rate of DD dimers, seemed associated with clinical~     complications. The deleterious role of increased oxidative stress has also been recently~     demonstrated in patients with sickle cell disease, opening new therapeutic avenues.~      This study aims to prospectively evaluate the management of sickle cell patients being~     admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction~     of the patients will be measured.~      The investigators will also evaluate the predictive value of several routine biological~     parameters regarding the severity of the crisis, including the values of nitrous albumin~     (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the~     team of Dr Wayenberg and Pr Bottari in Grenoble.~   "
51224|NCT02386644|"~     This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment~     compared with speculum examination, nitrazine and placental micro globulin-1 tests.~   "
51225|NCT02386631|"~     Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal~     joint and lateral deviation of the hallux. This common foot condition is associated with~     altered gait patterns. Specifically reduced forward propulsion, leading to gait instability.~     Research has shown that foot problems and pain play a major role towards the contribution of~     falls in the adult population. There are currently two main interventions for the treatment~     of hallux valgus: surgery and orthotic prescription. There has not been a lot of research~     performed evaluating the effects of custom orthotic prescription on hallux valgus.~      Therefore, this study will investigate adults with moderate hallux valgus and the effects of~     orthotic intervention on the efficacy of forward propulsion during walking. It is~     hypothesized that implementation of an orthotic will lead to decreased foot pain, an~     increase in step length, an increase in the forward moment about the ankle and hallux, and a~     more medial center of pressure tracking through the great toe instead of the lesser~     metatarsals.~      This study will consist of 10 adults. The participant will go through three rounds of~     testing in the lab. The first session will consist of initial baseline testing in which each~     participant will be evaluated for severity of Hallux Valgus and range of motion of the first~     metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the~     participant will be set up with markers, so as to record motion while they perform 15~     walking trials across a 10m runway with a force plate embedded in the middle whilst wearing~     standard footwear (no orthotic). The second lab session will consist of the standard~     footwear (no orthotic) walking as well as the addition of standard footwear with custom~     orthotic walking. The third session, after having worn the orthotic for two weeks, will~     repeat both conditions measured in the second lab session. Data about the center of pressure~     trajectories, step length, foot pain, and the moments about the ankle and first~     metatarsophalangeal joints will be collected and calculated.~   "
51226|NCT02386618|"~     Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of~     colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread.~     According to the investigators previous study, local residual neoplasia (LRN) after~     conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic~     therapy of LRN was not sufficient in 53 % and has not been standardized yet.~   "
51227|NCT02386605|"~     Negative symptoms significantly interfere with daily functioning among individuals with~     schizophrenia. They are strongly related to functional impairments [1] and contribute to the~     poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms~     interfere with obtaining and maintaining employment [2], forming social relationships[3] and~     living independently [4]. Developing treatments to effectively reduce negative symptoms is~     important to achieve improvements in daily functioning. Recent empirical studies report that~     psychosocial interventions for negative symptoms can have a moderate to large effect size on~     community functioning and negative symptom severity. However, the treatments that have been~     utilized so far are either cognitive-behavioral therapy interventions that require over a~     year of weekly individual sessions and thus are very resource- and time-intensive, or they~     are skills-training groups that do not address any of the cognitive and motivational aspects~     of negative symptoms. Although group treatments are increasingly hailed as the gold standard~     for schizophrenia, there is currently no group intervention explicitly for motivational~     negative symptoms and functional deficits. Furthermore, treatment development and clinical~     trials are increasingly reliant on neurophysiological measures of clinical severity and~     treatment response and so far there are not identified negative symptom biomarkers.~      The current CDA proposal will test a group-based treatment based on established motivational~     enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an~     active control group treatment, for improving motivational negative symptoms in Veterans~     with schizophrenia. I will assess the efficacy of MI with measures from two outcome domains:~     1) negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements~     in social, instrumental, and independent living). I will assess the relationship between~     these outcomes and neurophysiological biomarkers (pupillometry and electroencephalography~     (EEG)). Participants will be randomly assigned to the MI treatment or a control treatment~     for weekly 1-hour sessions for 12 weeks. The assessment battery will be administered at~     baseline, at completion of treatment, and at 6-month follow-up. The investigators will~     enroll 60 Veterans with schizophrenia that are low functioning and have high negative~     symptoms across the 4 years of the study.~      This proposal is designed to examine group-based MI for reducing negative symptoms and~     improving functioning in key domains (i.e., interpersonal, instrumental, and independent~     living skills). Moreover, it will thoroughly investigate biomarkers of negative symptoms~     with pupillometry and EEG. The development and evaluation of this recovery- oriented group~     MI treatment for Veterans with disabling negative symptoms will yield results that can~     inform larger treatment trials and neurophysiological measurement of negative symptoms in~     Veterans with schizophrenia.~   "
51228|NCT02386592|"~     The purpose of this study is to estimate the burden of disease, identify risk factors~     associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost~     measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the~     investigators propose to study the impact of a novel package of infection control~     interventions on nosocomial bacteremia and mortality among neonates at a tertiary care~     center in sub-Saharan Africa.~   "
51229|NCT02386579|"~     The study is designed to investigate biomarkers related to bone turnover in diabetics with~     charcot foot. This is done by measuring local blood samples in the feet, and systemically in~     a vene and an artery. Measurements are done before and after cooling the feet in icewater to~     lower the bloodflow.~      Patients will be compared with healthy diabetic controls.~   "
51230|NCT02386566|"~     The primary objective of the study is to determine the association between prospectively~     measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple~     Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to~     1 year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab.~     The secondary objectives of this study are as follows: To evaluate the cumulative~     probability of sustained EDSS changes at 1 year following natalizumab treatment initiation;~     To evaluate the association between disability (EDSS), fatigue (Fatigue Scale of Motor and~     Cognitive Function [FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality~     Questionnaire-19 [MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS])~     and neurocognitive function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D~     Questionnaire (EQ-5D) at 3 to 6-months intervals up to 1 year after initiation of~     natalizumab treatment; To assess the relationship between clinical disease-free status (no~     EDSS increase of 1.0 and no relapse) and MusiQoL at 1 year following natalizumab treatment~     initiation; To record the number of clinical relapses and relapses requiring steroid~     treatment at 3-months intervals up to 1 year after initiation of natalizumab treatment; To~     describe changes in work impairment (Work Productivity and Activity Impairment in MS~     [WPAI-MS]) at 3-months intervals up to 1 year after initiation of natalizumab treatment; To~     describe any change in the percentage of disability pension and occupation after 1 year of~     natalizumab treatment; To record the incidence and number of Serious Adverse Events (SAE)~     and Suspected Unexpected Serious Adverse Reactions (SUSAR) throughout the study~   "
51231|NCT02386553|"~     The primary objective of the study is to examine the efficacy of multiple doses of~     Nusinersen administered intrathecally in preventing or delaying the need for respiratory~     intervention or death in infants with genetically diagnosed and presymptomatic spinal~     muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of~     Nusinersen in infants with genetically diagnosed and presymptomatic SMA.~   "
51232|NCT02386540|"~     The purpose of this study is to determine whether health coaching initiated in the emergency~     department (ED) reduces subsequent ED visits, increases primary care visits, and positively~     impacts health outcomes in patients with diabetes and/or hypertension.~   "
51262|NCT02386150|"~     This study seeks to determine the safety and immunogenicity of a series of 3 primary~     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA~     1-33/44-198) vaccine (RVEc) at 10 or 20 μg intradermally (ID). This study is evaluating if~     RVEc will display an acceptable safety profile as determined by adverse event (AE) data and~     if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in~     vaccine recipients.~   "
51233|NCT02386527|"~     Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it~     is estimated that as many as 3 million adults may suffer from the disease. Fortunately in~     the last few years, a shift in strategy toward the earlier institution of disease modifying~     drugs and the availability of new classes of medications have greatly improved the outcomes~     that can be expected by most patients.~      The goal of treatment now aims toward achieving the lowest possible level of arthritis~     disease activity and even remission, if possible as early on as possible. Research has shown~     that this translates into minimized joint damage and enhanced physical function and quality~     of life for the RA patient. This also requires that a diagnosis of RA be made as early on as~     possible, and herein lies the challenge, i.e. identifying the RA patient early on in the~     course of their disease.~   "
51234|NCT02386514|"~     To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to~     the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency~     Department.~   "
51235|NCT02386501|"~     This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the~     maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of~     ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.~   "
51236|NCT02386488|"~     The purpose of this study is to determine the pharmacokinetic (PK) parameters of~     vortioxetine after single and multiple oral dosing to healthy Chinese men and women.~   "
51237|NCT02386475|"~     Cortical plasticity plays a pivotal role in functional recovery after a stroke.~     Neurotransmitter release, facilitates the creation of new synapses and promotes brain~     plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the~     release of neurotransmitters in patients with first stroke.~   "
51238|NCT02386462|"~     Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway~     (LMA) insertion with minimal effect on respiratory function. The purpose of the study was to~     determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion~     during anaesthesia induction with propofol 2.0 mg/kg.~   "
51239|NCT02386449|"~     This is a randomized, controlled, parallel group, assessor-blinded study to compare two~     colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion~     criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or~     Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before~     colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take~     Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.~   "
51240|NCT02386436|"~     GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is~     being developed for the treatment of inflammatory and fibrotic diseases. This first time in~     human study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic~     (PD) and immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811,~     in healthy subjects.~      This study will be a randomised, double-blind (sponsor open), placebo-controlled, single~     centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy~     subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each~     cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive~     GSK2330811 and 2 subjects will receive placebo.~      The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose~     and the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the~     clinical unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a~     s.c. dose of GSK2330811 or placebo. Subjects will then remain as an in-patient until~     discharged on Day 8, after assessments have been performed. The duration of the study,~     including screening, is approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.~   "
51241|NCT02386423|"~     The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap~     that produces adjustable targeted pressure on specific muscles in the feet, to reduce the~     symptoms of moderate to severe primary Restless Legs Syndrome.~   "
51242|NCT02386410|"~     Anxiety is the most frequent psychiatric problem in children. Untreated anxiety often has a~     chronic course, or may be a recurring condition. Anxiety in children predicts a variety of~     psychiatric disorders later in life, and involves problems regarding school performance and~     social relations. The literature provides a number of factors, which are suggested to~     increase the risk of developing an anxiety disorder. In particular, it has been shown that~     children of parents with anxiety disorders are at much greater risk of developing an anxiety~     disorder. Several studies have found a correlation between anxiety in the child, and parent~     behavior characterized by criticism, control and overprotectiveness. The present study aim~     to preliminary evaluate whether a eight week parent training intervention can reduce the~     incidence of anxiety disorders in children and to evaluate the feasibility of the parent~     training. Three central factors has been the basis in developing the parent training, all of~     which are considered to be involved in the development and maintenance of anxiety disorders~     in children (1) criticism and rejection, (2) control and overprotectiveness, and (3)~     parental modeling and reinforcement of anxiety. The goal of the parent training is therefore~     (1) to increase warmth and acceptance, (2) to increase autonomy for the child, and (3)~     modeling and reinforcement of brave behavior. The investigators intend to include 60 anxious~     parents in the study, who will be randomly allocated to either group parent training,~     Internet delivered parent training, or wait-list condition. The inclusion criteria are as~     follows: The parent states that he/she experiences anxiety or worry, the parents' child is~     6-12 years old, and do not fulfill criteria for an anxiety disorder or major depressive~     disorder, the parent possesses everyday access to the Internet, and there is no presence of~     very aggravated family situations, such as parent substance abuse or severe depression, or~     domestic violence.~   "
51243|NCT02386397|"~     This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib~     administered in combination with mGEMOX in patients with advanced biliary tract cancer.~   "
51244|NCT02386384|"~     Question: Can implantation failure (IF) be predicted prior to in vitro fertilization (IVF)?~     A pilot, non-interventional, clinical study Prospective, controlled, cohort study~   "
51245|NCT02386371|"~     The investigators propose a prospective, multicenter, single arm Phase II design to evaluate~     the feasibility of repeated breast-conserving surgery combined with re- irradiation using~     IORT after local recurrence of breast carcinoma.~   "
51246|NCT02386358|"~     The purpose of this study is:~        1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution~          of chronic Chagas disease in adult patients by means of a randomized, double-blind~          clinical trial (RCT).~           Also:~        2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of~          Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared~          with conventional serology (CS)~        3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite~          load as an early therapeutic effect.~        4. to determine the potential of such serological and parasitological methods as~          predictors of therapeutic effect or failure.~   "
51247|NCT02386345|"~     This is a registry to assess the safety and effectiveness of FIRM guided procedures for the~     treatment of symptomatic any type of atrial fibrillation.~      FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors~     identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView®~     mapping system. In addition to the FIRM guided ablation any other ablation method could be~     applied.The acute success of FIRM ablations is defined as elimination of rotors defined by~     absence of rotors.~      Data items will be collected, if available, consistent and applicable with routine and~     standard clinical care at each participating site.~   "
51248|NCT02386332|"~     This is an open-label, prospective, observational, multicenter, randomized study to compare~     the efficacy between unrelated umbilical cord blood transplantation (UCBT) and~     HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative~     conditioning for adult patients with hematologic malignancies.~   "
51249|NCT02386319|"~     ﻿The study's main objective is to investigate melatonin's analgesic, anxiolytic and~     sleep-regulating effects in patients undergoing cosmetic breast surgery. Moreover, the~     investigators intend to investigate the pharmacokinetic parameters of melatonin in this~     patient population.~   "
51250|NCT02386306|"~     This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study~     designed to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects~     with mild to moderate Alzheimer's Disease (as determined by 2011 National Institute on~     Aging- Alzheimer's Association [NIA-AA] criteria and Mini Mental State Examination [MMSE]).~     The Investigator, study site staff, (with exception of a designated pharmacist/pharmacy~     technician) and all study subjects will be blinded to randomized study medication assignment~     until database lock. Treatment assignments may be unblinded for select pre-authorized~     individuals involved in the safety and PK data reviews in order to accurately determine how~     to proceed with dose escalation.~   "
51251|NCT02386293|"~     The purpose of this study is to test the hypothesis that hypertension increases the~     anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in~     overweight/obese African-American's who retain sodium during mental stress.~   "
51252|NCT02386280|"~     To investigate whether brief motivational intervention is associated with the change of~     parenting style in parents of teenagers seeking to prevent drug use among their children.~   "
51253|NCT02386267|"~     Diamond-Blackfan anemia (DBA) is a rare congenital syndrome associated with physical~     anomalies, short stature, red cell aplasia, and an increased risk of malignancy.~      Mutations affecting genes encoding ribosomal proteins cause DBA. Genetic studies have~     identified heterozygous mutations in at least one of eight ribosomal protein genes in up to~     50% of cases.~      25% of patients carry a mutation in the ribosomal protein (RP)S19 gene, whereas mutations in~     RPS24, RPS17, RPL35A, RPL11, and RPL5 are rare.~      p53 activation has been identified as a key component in the pathophysiology of DBA after~     cellular and molecular studies. Other potential mechanisms that warrant further~     investigation include impaired translation as the result of ribosomal insufficiency, which~     may be ameliorated by Leucine supplementation.~      Despite significant improvements in understanding of the pathophysiology of Diamond Blackfan~     anemia (DBA), there have been few advances in therapy. The cornerstones of treatment remain~     corticosteroids,chronic red blood cell transfusions, and hematopoietic stem cell~     transplantation, each of which is fraught with complications. Other treatments have been~     shown to be effective in only a few patients or in individual case reports : IL-3,~     cyclosporine (alone or in combination with steroids), metaclopramide. Gene therapy is still~     a part of research programs.~      There are some indications that the Amino Acid (AA) L-leucine, a translation enhancer, may~     have some efficacy in DBA and 5q-syndrome, which has the same altered ribosome functions as~     the DBA. L-leucine is an essential AA that is unique among the branched-chain AA acting as a~     nutrient regulator of protein synthesis in skeletal muscle and adipose tissue.~      Several preclinical studies with DBA lymphocytes exposed to various L-leucine doses, have~     demonstrated that protein synthesis can be increased by using high doses L-leucine.~      Recent clinical data on L-leucine therapeutic use have demonstrated increase the hemoglobin~     level and transfusion independence in patients with DBA and 5q-syndrom.~      These data support the rationale for clinical trial on L-leucine use as a therapeutic agent~     for DBA patients.~   "
51254|NCT02386254|"~     To evaluate whether a premorbid functioning scoring system such as the ECOG system can be~     adapted to predict ICU morbidity and mortality.~   "
51255|NCT02386241|"~     This study will compare genomic alterations between the parents and the patients with~     high-grade glioma.~   "
51256|NCT02386228|"~     A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under~     6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.~   "
51257|NCT02386215|"~     This randomized controlled trial will explore whether the provision of oral HIV self-test~     kits to women can increase HIV testing among their male partners. The study will recruit~     adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be~     randomized to either receive two HIV self-tests or to receive counseling referring their~     partner to HIV testing (standard of care). Over a 3 month period, we will obtain information~     from study participants on how many sexual partners they offered the tests to, the~     receptivity of their sexual partners to using self-tests, and the incidence of any adverse~     events. We will compare partner testing rates in intervention and control groups.~   "
51258|NCT02386202|"~     To determine the incidence and predictors of augmented renal clearance (ARC) in patients~     with hemorrhagic stroke.~   "
51259|NCT02386189|"~     The purpose of this study is 1) to learn how VA patients can help share their health~     information between their VA providers and providers outside the VA and 2) if sharing this~     information is useful to providers and improves care received.~   "
51260|NCT02386176|"~     The investigators are interested in assessing the value of and comparing the use of~     automated breast ultrasound (ABUS) (either as a primary screening approach or as a~     supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this~     project is to perform a preliminary prospective study on women who are most likely to~     benefit from the use of ABUS and/or DBT (or a combination of both) in the screening~     environment.~   "
51261|NCT02386163|"~     According to many researches, mesenchymal stem cells (MSC) isolated from synovial membrane~     and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and~     ability to undergo chondrogenesis.~      Based on this concept, the investigators plan to get two removed tissues (synovial membrane~     and infrapatellar fat pad) from patients who have an operation of TKR (Total Knee~     Replacement). The investigators are going to isolate and expand MSC from these two tissues~     respectively, and then compare their characterization and potential for clinical~     application. In the other hand, the investigators plan to build techniques and procedures~     which comply with Good Tissue Practices (GTP).~   "
53481|NCT02357082|"~     Registry intends to prospectively collect data regarding the safety of magnetic resonance~     imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter~     defibrillators.~   "
51263|NCT02386137|"~     Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is~     increasingly being used worldwide to treat symptomatic uterine fibroids because of its~     excellent therapeutic efficacy in controlling symptoms and its excellent safety record.~     Despite the benefits, it should be recognized that MR HIFU ablation does not always yield~     good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume~     transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most~     well-known risk factors for poor ablation outcomes as measured with the non-perfused volume~     (NPV) ratio (ie, NPV divided by fibroid volume).~      The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and~     contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion~     imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine~     fibroid treatment by MR-HIFU.~   "
51264|NCT02386124|"~     In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50~     years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%,~     respectively, due to more effective therapies and lower mortality of many diseases. Yet,~     chronic diseases are nowadays more important, and often coexist as comorbidity or~     multimorbidity, depending on whether an index condition has been considered. These~     conditions increase the risk of death and reduce functional autonomy in the elderly and,~     therefore, should be carefully considered within comprehensive geriatric assessment. The~     epidemiology of cardiovascular disease, as demonstrated among others by the Oxford Vascular~     Study, shows a clear trend in age-dependent, as the number of events and their incidence~     increases with age, and about half are concentrates over 75 years.~      In addition, some observational studies in elderly patients have suggested an association~     between frailty and cardiovascular disease: fragility and cardiovascular disease share a~     common biological pathway, and cardiovascular diseases may accelerate the onset of frailty.~     The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease,~     according to the rating scale used and the population studied. Frail patients with~     cardiovascular disease, in particular those undergoing invasive procedures or suffering from~     coronary artery disease and aortic valve disease, have a much higher adverse events and~     complications, suggesting the need for a more accurate functional stratification and a more~     careful evaluation of the risk/benefit ratio of some invasive procedures.~      Among the numerous tests proposed in the literature for the functional evaluation and~     objective measures of physical capability in elderly patient, the Short Physical Performance~     Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those~     characterized by an improved prognostic ability and an easy administration.~      The present study is performed to assess if SPPB and handgrip are helpful to better stratify~     the prognosis (all-causes death and hospital admission for all causes) in elderly patients~     admitted to hospital for cardiac causes.~   "
51265|NCT02386111|"~     This is a study to determine the clinical benefit (how well the drug works), safety, and~     tolerability of combining varlilumab and sunitinib. The study will enroll patients with~     metastatic clear cell renal cell carcinoma.~   "
51266|NCT02386098|"~     The purpose of this study is to evaluate whether the combination of BMS-955176 with~     atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,~     safe, and well-tolerated in HIV-1 infected treatment experienced adults.~   "
51267|NCT02386085|"~     Currently, there is a significant deficiency in evidence regarding the safety of osteopathic~     manipulative treatments (OMT). To address this deficit, this study is designed to~     systematically evaluate the incidence and severity of OMT adverse events and examine the~     relationship of these adverse events to the technique(s) used and the body region(s)~     treated. The study is being conducted at the clinics of participating members of~     DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic~     manual medicine research. Eligible patients who receive OMT at one of the participating~     clinics will be asked to complete either a paper or online survey regarding any adverse~     events they experience within 1, 3, and 7 days following their treatment. Information~     regarding their diagnoses, which osteopathic techniques were used in their OMT, and which~     body regions were treated will be obtained from participant medical records. This data will~     be used to answer the following research questions:~        1. What is the incidence of adverse events from osteopathic manipulative treatment?~        2. What types of adverse events occur following osteopathic manipulative treatment?~        3. Are there individual osteopathic techniques in particular body regions that have higher~          incidences of adverse events than other techniques or body regions?~        4. Is the incidence of adverse events higher for some patient conditions than others?~   "
51268|NCT02386072|"~     A study to identify factors that are associated with improved effectiveness in pharmacologic~     therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF~     (Overactive Bladder Questionnaire Short Form)~   "
51269|NCT02386059|"~     Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea~     and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence~     may be the long duration of surgery and anesthesia and the high degree of manipulation of~     the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset~     of several complications, such as suprachoroidal hemorrhage, with disastrous visual~     consequences.~      To date there is no evidence as to the possible protective effect of anti-emetic therapy~     with regard to interventions of vitrectomy performed under local anesthesia.~      In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy~     of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and~     vomiting in patients undergoing vitrectomy under local anesthesia.~   "
51270|NCT02386046|"~     This study aims to determine normative values of oxygen saturation in late preterm infants,~     and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and~     those not requiring it.~   "
51271|NCT02386033|"~     ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A~     reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The~     aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an~     adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II~     furcation defects.~      Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP~     plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD),~     relative vertical clinical attachment level (RVCAL) , relative horizontal clinical~     attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque~     index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment~     of bone defect fill was done at 6 and 9 months, using a computer-aided software.~   "
51272|NCT02386020|"~     The present study is designed to investigate the effectiveness of AV gel local drug delivery~     as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic~     periodontitis (CP) and type 2 diabetes mellitus (DM).~   "
51273|NCT02386007|"~     The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and~     safety of each dosage group in Korean patients with acute and chronic gastric inflammation.~   "
51276|NCT02385968|"~     The aim is to investigate if herniated nucleus material in lumbar disc herniations is~     infected with bacteria, and if so, to determine their prevalence (control group), and to~     determine if patients with pre-existing Modic changes type 1 have a higher incidence of~     bacterial growth in relevant lumbar disc samples than patients without Modic changes.~      A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery~     will be examined.~   "
51277|NCT02385955|"~     This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical~     cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two~     myeloablative conditioning regimens will be used in this study: (1) total body irradation~     (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.~   "
51278|NCT02385942|"~     The purpose of this study is to analyse utility and compatibility of U-health solution~     service based on mobile for chronic wound management.~   "
51279|NCT02385929|"~     The purpose of this study is to explore whether early initiated physical exercise concurrent~     with a swallowing and mouth opening exercise program will have a positive effect on~     swallowing function and other quality of life aspects in patients treated with radiotherapy~     for head and neck cancer. The investigators hypothesize that patients who complete the~     program will have improved swallowing function and physical function one year after~     completing their treatment compared to patients who do not participate in the training~     program.~   "
51280|NCT02385916|"~     According to the Canadian Cancer Society, 1 in 9 Canadian women will develop breast cancer~     in her lifetime and 1 in 30 will die. The single greatest risk factor of breast cancer is~     poor estrogen metabolism. EstroSense®/MD is a natural health product that promotes and~     supports healthy estrogen metabolism. It may increase the ratio of good estrogen to bad~     estrogen and potentially reducing the risk of breast cancer. For this proposed study, the~     investigators will be examining the effect of EstroSense®/MD compared to placebo, on~     estrogen metabolism in 120 women.~   "
51281|NCT02385903|"~     Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in~     diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization~     procedure cannot be provide in all cases. Flammacerium, by a crust training and its~     anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination~     and then improve some incapacitating symptoms like odor or pain. This product may allow to~     delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the~     investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of~     the lower limb in patients where no revascularization can be provide. The investigators~     observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution,~     wound size decrease.~   "
51282|NCT02385890|"~     The objectives are to test the acute effects of different bagels containing pulse~     ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2)~     food intake two hours following consumption of pulse products.~      The investigators hypothesize that bagels containing pulse ingredients will lead to lower~     blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.~   "
51283|NCT02385877|"~     The purpose of this study is to perform first-in-human PET imaging studies of two new~     cardiac sympathetic nerve imaging agents, 4-[18F]fluoro-meta-hydroxyphenethylguanidine~     ([18F]4F-MHPG) and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG).~   "
51284|NCT02385864|"~     Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite~     the current use of three or more antihypertensive drugs at full doses, including a diuretic.~     Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly~     prevalent in patients with resistant hypertension.~      The prospective observational POP-ART study will assess the efficacy of continuous positive~     airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect~     data from usual care.~   "
51285|NCT02385851|"~     This is a randomized, double-blind, single-dose, 2-period crossover study in healthy~     subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg~     subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.~   "
51286|NCT02385838|"~     The purpose of this interventional study is to compare the impact of four different~     Front-Of-Pack (FOP) nutrition labels on purchasing intentions. This study is nested in the~     ongoing web-based prospective observational NutriNet-Santé cohort study, including on~     December 2014 around 150,000 participants. The investigators will perform a five-arm~     randomized trial where participants will be subjected to different FOP nutrition label~     formats: Guidelines Daily Amount (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition~     Label (5-CNL), Green Tick (Tick) and a 'no label' condition. The impact of front-of-pack~     nutrition labels on the nutritional quality of the shopping cart will be assessed.~     Participants from the NutriNet-Santé cohort study will be randomly assigned to one of these~     five experimental conditions according to their sociodemographic characteristics.~      Purchasing intentions will be assessed using an experimental web-based supermarket designed~     to look like a regular online grocery store. The supermarket includes 269 unique products~     divided into 4 categories: dairy products, processed meat/delicatessen, savory and~     breakfast/sugary products. Each category is then separated into specific products families~     like yogurt, milk, cheese, etc. for the dairy products category. Inside a food family, the~     selection of foodstuffs will be made to obtain a representative sample of the products~     commonly sold in French supermarket. For each type of products, at least two variants are~     proposed. Products are retailers or manufacturers branded. Categories of products that are~     not usually bought each week, or which are likely to be bought from different sources are~     not included on the web-based supermarket.~      Participants are asked to simulate a shopping situation: they have to select a week worth of~     food for their family among proposed products. If the user is not able to find a product~     he/she usually buy, the instruction is to select similar product among proposed ones.~      Information provided for each product is: name, price and the picture with the FOP label/or~     not according to the experimental condition to which the participant is allocated. A brief~     explanation of the FOP label used is also given.~   "
51287|NCT02385825|"~     This study seeks to determine the safety and immunogenicity of a series of 3 primary~     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA~     1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will~     display an acceptable safety profile as determined by adverse event (AE) data and if RVEc~     will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine~     recipients.~   "
51288|NCT02385812|"~     Asbestos defines a group of naturally occurring mineral silicate fibers which are easily~     inhaled, resulting in a variety of diseases of the respiratory system including lung cancer~     and malignant mesothelioma. Despite some advances in treatment, there has been little impact~     on overall survival for both lung cancer and mesothelioma in the past 20 years in great part~     because patients usually present with disease at an advanced and incurable stage. This study~     aims to develop and implement a low-dose computed tomography (LDCT) screening approach for~     lung cancer and mesothelioma in asbestos-exposed workers in Alberta.~   "
51289|NCT02385799|"~     This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old~     inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant~     will receive a series of tests at both the beginning and end of the study. The researchers~     hope to show improvements in language and social deficits.~   "
51290|NCT02385786|"~     This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive~     Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from~     baseline to completion of treatment at 8 weeks in terms of depression severity using the~     Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure~     of inflammation, over the same time period.~   "
51291|NCT02385773|"~     This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in~     Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will~     enroll children between the ages of 6 months and 3 years and will assess the impact of the~     study nutrition product on the duration and severity of diarrhea and on weight recovery in~     the 4 weeks following the diarrheal episode. The investigators will be determining the~     etiology of the diarrhea episode to ascertain if the nutritional product works better for~     certain etiologies or has a non-specific benefit.~   "
51292|NCT02385760|"~     A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and~     safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.~   "
51293|NCT02385747|"~     100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to~     transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional~     curettage followed by histopathological examination and immunohistochemical analysis for~     estrogen and progesterone receptors.~   "
51294|NCT02385734|"~     This study hypothesized that Concentrated Growth Factors'(CGF) placement together with~     Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of~     this study was to determine the clinical effect of CGF combination with CAF compared to CAF~     alone in the treatment of adjacent multiple gingival recessions.~   "
51295|NCT02385721|"~     Evaluated the incidence and characteristics of adverse events during the treatment for~     Kanarb tablet.~   "
51296|NCT02385708|"~     Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line~     to toes will decrease surgical site infections (SSI) by 30% when compared to patients who~     receive routine standard of care (use of chlorhexidine cloths night before surgery and~     morning of surgery).~   "
51297|NCT02385695|"~     The purpose of this study is to compare outcomes of (i) surgical treatment with posterior~     dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in~     patients with multilevel lumbar degenerative disk disease.~   "
51298|NCT02385682|"~     The purpose of this registry is to evaluate long-term clinical events in patients with acute~     myocardial infarction who were treated with percutaneous coronary intervention.~      Although numerous articles have been published by using nationwide Korean myocardial~     infarction registries, such as the Korea Acute Myocardial Infarction Registry (KAMIR),~     limitation of previous registries is that these have little data beyond the first year of~     MI. Therefore, current registry was designed to assess long-term clinical events in patients~     with acute myocardial infarction.~      Because most of myocardial infarction patients were treated by revascularization in real~     world of Korea, this registry limits the inclusion criteria to patients who were treated~     with percutaneous coronary intervention to reduce the bias.~   "
51299|NCT02385669|"~     This study evaluates whether it is safe to administer a peptide vaccine with ipilimumab.~     This study will also evaluate the effects of the combination of the peptide vaccine and~     ipilimumab on the immune system. The investigators will monitor these effects by performing~     tests in the laboratory on participants' blood, a lymph node, and tumor samples.~   "
51300|NCT02385656|"~     Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and~     somnolence in cancer-patients.~   "
51301|NCT02385643|"~     Background: Interactive and mobile technology to manage alcohol use problem potentially~     provide continuing care by offering emotional and instrumental support anywhere and in time,~     but the effectiveness for maintaining abstinence has not been examined. the investigators~     will evaluate in this study whether the smartphone-based support system would improve~     outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring~     and self-management, the phone support system prompts subjects to take Breath Alcohol~     Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system~     also offers instantaneous feedback, self-management strategies, and anonymous mutual social~     support from other subjects.~      Methods: This three-year project will be conducted in three stages, including pilot study,~     efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants~     will be given a smartphone (if the subject does not have one), breathalyzer and training~     session. In the pilot study stage,10 subjects will be enrolled to validate the system. In~     the efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100~     post-detoxification alcohol dependent patients who are randomized to (1) standard treatment~     (ST) group or (2) standard treatment plus phone-based support group (technology~     intervention, TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to~     record the frequency and quantity of alcohol consumption, visual analogue for craving, Beck~     Depression Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale~     (SWLS), and Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the~     12-week trial, the investigators will take back the support system and follow the all~     subjects in both groups for another 12 weeks, i.e. post-intervention stage, to further~     understand the sustaining benefit from intervention. In addition, the investigators will~     identify the clinical variables or system factors that are associated with outcome measures.~      Expected results: In this study, the investigators expect that in treatment-seeking alcohol~     dependent patients, a smartphone-supported self-management program, adding on to~     conventional treatment, will be beneficial in improving the drinking outcomes such as a~     higher abstinence rate, a lower relapse rate, and a lower drinking frequency and quantity.~   "
51310|NCT02385526|"~     Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability~     and clinical outcomes study to determine the number of patients achieving their final~     assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being~     treated with adjunctive VNS Therapy using new titration protocols.~   "
51319|NCT02385409|"~     Preoperative anemia is an independent risk factor for the need for allogeneic transfusion~     during surgery and increased postoperative morbidity.~      Treatment of preoperative anemia is recommended. However the type of preoperative anemias in~     elective hip- and knee surgery has only been sparsely studied.~      This observational study aims to investigate the incidence and type of anemias prior to~     elective hip- and knee arthroplasty.~   "
51320|NCT02385396|"~     The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate,~     embryo development dynamics and oestradiol and progesterone concentration in blood serum and~     Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with~     Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).~   "
51302|NCT02385630|"~     Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but~     while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best~     chance of cure, these are major operations associated with specific long term complications.~     Weight loss and poor nutrition are relatively common problems among patients who attain~     long-term cancer remission and cure after surgery. The mechanisms underlying these problems~     are not well understood and therefore treatment options are limited.~      The investigators research has demonstrated increased levels of chemical messengers (gut~     hormones) released from the gastrointestinal tract after meals in patients who have~     previously undergone upper gastrointestinal surgery. These chemical messengers play a role~     in signalling the feeling of fullness during and after a meal (satiety). Understanding the~     mechanisms involved in increased gut hormone secretion after these operations may allow us~     to use certain medications to block gut hormone release and hence reduce satiety allowing~     patients to eat more, regain weight and prevent nutritional complications after surgery.~      Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have,~     however, only been established cross-sectionally and therefore the time course for~     development of increased gut hormone secretion is unknown. Data collected from this study~     will provide important information about optimal timing of therapeutic intervention in this~     patient group, while offering mechanistic insights with regard to the pathophysiologic~     process underlying post-operative early satiety.~   "
51303|NCT02385617|"~     Improvements to treatment strategies for patients upper gastrointestinal cancers have~     produced an increasing population of people who remain free from disease recurrence in the~     long term. Weight loss and nutritional problems are common among patients who attain~     long-term remission and cure after surgery for upper gastrointestinal cancers. However, the~     mechanisms underlying these problems are not well understood. In this study the~     investigators aim to determine whether reduced food intake after upper gastrointestinal~     surgery is caused by early satiety related to exaggerated post-prandial gut hormone~     responses.~      This is a randomized, double-blind, placebo controlled, crossover study of the effect of~     100μg octreotide SC on ad libitum food intake in patients free from complications or~     recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A~     comparator group of age, weight and gender matched subjects will be studied concurrently,~     and caloric intake and subjective symptom scores after administration of octreotide versus~     placebo among surgical and comparator subjects will be assessed.~   "
51304|NCT02385604|"~     A major focus of research in oncology is to identify patients who, following induction~     therapy, have a complete pathologic response, presenting opportunities for novel trials,~     including extended therapy or non-operative approaches, in addition to identifying cohorts~     who are resistant to the neoadjuvant therapy. The current gold standard for determining~     response to CRT is pathological evaluation following surgical resection, in particular the~     Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however,~     there is no preclinical early response or post-treatment biomarker, nor endoscopic or~     radiologic assessment that predicts pathologic response prior to surgical resection.The aim~     of this study is to determine the accuracy of CT-PET for prediction of histopathologic~     response and/or oncologic outcome for patients with esophageal cancer.~   "
51305|NCT02385591|"~     This research aims to investigate the effectiveness of an automated Simple Message Service~     (SMS, also known as text messaging) advisor system relative to a proven human advisor~     program to promote regular, sustained physical activity among inactive, overweight Latinos.~     The SMS Advisor program represents a potentially lower-cost and high yield alternative to~     person-delivered health promotion programs that could be more rapidly disseminated with~     greater and faster uptake.~   "
51306|NCT02385578|"~     AIM Verified if the first stage of the Train the trainer (TTT)plan could improve the young~     endoscopist's ability to detect the early gastric cancer（EGC）.~      METHOD~        1. a retrospective analysis of the ten young endoscopist's painless gastroscopy~          examination from January 1, 2014 to December 31, 2014. According mainly to the~          endoscopic report and pateint's History, quantity of gastroscope, gastric cancer and~          the early gastric cancer.~        2. the first step of the train the trainer plan(TTT) activised in March 19-20,2015,which~          including the diagnosis and operation hand in hand teach by Professor Yano~          Takeshiin,and the case discussion,and so on. Five young endoscopist accepted the TTT~          plan and the other five not accepted.~        3. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT~          content (for the T1 period),.(1) the patient's name, (2)gender, (3)age,(4)past medical~          history (Helicobacter pylori<HP>, gastritis, gastric ulcer, oral drug operation,~          etc.),（5）gastroscope operation time,(6)the location of the lesion- longitudinal (upper,~          middle and lower),(7) the location of the lesion -circumferential (lessor curvature,~          Greater curvature, anterior wall, posterior wall),(8) lesion size, (9)conventional~          white-light imaging (red, white, no change), (10)magnifying endoscopy with narrow-band~          imaging (EM-NBI) microvascular and mirosurface pattern VS classification system(VSCS)~          (boundaries, microvascular pattern and microsurface pattern; don't do it),~          (11)microscopy types (uplift type, flat type, concave type or IIc I/IIa or IIb),~          (12)histological type (differentiated and undifferentiated type) and (13) pathological~          (low grade neoplasia, high-level neoplasia etc.). For the treatment of endoscopy~          submucosal dissection (ESD) patients, further pathological results were recorded after~          ESD, including the pathology, edge and basal conditions. The other five doctors do the~          gastroendoscopy as they do before. (300 cases / person)~        4. 2-4 TTT activity ;The five doctors who accepted the TTT do the gastroendoscopy in~          accordance with the TTT content (for the T2-T4 period),.The other five doctors do the~          gastroendoscopy as they do before.~        5. Statistics the number of early gastric cancer have been found by the five young~          doctors, and how mang gastroscopy they have done.pay attention to The rates of EGC~          detection.~   "
51307|NCT02385565|"~     The aim of the present study is to compare Resting Energy Expenditure (REE) between normal~     fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial~     cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced~     thermogenesis (DIT) and body composition between NFD vs HFD.~      This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids,~     45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 %~     lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation~     criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry~     ). 36 included MID subjects will be included in this study. Main evaluation criteria and~     second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.~   "
51308|NCT02385552|"~     The purpose of this study is to determine clinical factors affecting quality indicators of~     colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be~     elevated by improving related factors.~   "
51309|NCT02385539|"~     To find the optimal dose and combination of small dose of Levobupivacaine (LB)~     coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest~     probability for not developing hypotension and the lowest opioid side effect that would be~     sufficient to achieve and maintain a sensory block to the tenth thoracic dermatoma (T10) in~     elderly patients for surgery lasting > 45 minutes as compared with large dose of~     Levobupivacaine alone.~   "
51311|NCT02385513|"~     A single centre open-label, parallel group, randomised controlled trial, recruiting healthy~     Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital,~     Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10)~     at either;~        1. 6+10 weeks and 9 months OR~        2. 6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each~          treatment arm (304 in total). Demographic and clinical data will be collected on an~          electronic case report form to allow monitoring remotely. Participants will receive the~          study vaccine according to their allocated treatment arm in addition to their other~          routine vaccines. The investigators will collect 3 blood samples for analysis of serum~          antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The~          data collected will be analysed in order to determine whether the 6+10 schedule is~          non-inferior to the 6+14 schedule in generating immune responses against the vaccine~          serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform~          decision-making around augmenting the currently recommended 6+14 schedule to a 6+10~          schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time~          points to look at carriage of pneumococcus over time and to assess differences between~          the 2 groups. This is of critical importance because much of the programmatic impact of~          PCV is ultimately conferred by reductions in carriage at the community level and~          indirect effects resulting from that NP protection.~   "
51312|NCT02385500|"~     Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary~     tract dysfunction. Their symptoms can be managed with antimuscarinics with variable~     efficacy. Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary~     frequency, urgency and nocturia in this patient population. The purpose of this protocol is~     to compare the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep~     problems in a heterogeneous population of PD patients in a cross-over fashion.~      A representative number of patients with baseline overactive bladder (OAB) symptoms and~     Parkinson's disease will be recruited to receive either the active drug or placebo for the~     first phase of eight weeks. The groups will then be crossed-over during the second phase of~     eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding~     diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale~     (PDSS).~   "
51313|NCT02385487|"~     Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an~     imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in~     patients with critical illness and strongly associated with mortality, the pathophysiology~     remains poorly understood. Inflammation is central to the development of atherosclerosis,~     plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and~     myocardial necrosis has not been defined. The investigators aim to to delineate the~     mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical~     medical illness.~   "
51314|NCT02385474|"~     Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood~     disease. Poor dentition significantly affects the nutrition, growth, development and general~     health of children. Conventional dental care for ECC is neither affordable nor accessible,~     particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe,~     cost-effective caries-arresting agent that appears to conform to the World Health~     Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically~     used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an~     evidence base. Therefore it is necessary to find the most suitable SDF concentration and~     application interval to arrest ECC. The purpose of this randomised controlled trial is to~     compare the efficacy of two commercially available SDF solutions at pre-prepared~     concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months~     in arresting caries in primary teeth.~      Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4~     years with caries. The sample size is sufficient for the appropriate statistical analyses.~     The children were classified into high and low caries rates and equally allocated into four~     groups for the caries treatment:~      Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group~     C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The~     children will be followed for 36 months in their kindergartens until they enter primary~     school. Clinical examinations at 6-month intervals will be conducted to assess whether the~     caries are arrested. Information on confounding factors, such as oral hygiene habits and the~     use of other fluoride agents, will be collected through a parental questionnaire at the~     baseline and follow-ups.~      Discussion: This study will help determine the most suitable SDF concentration and~     application interval to arrest caries in children. Because SDF use for caries arrest is~     painless, simple, and low-cost, it can be widely recommended and promoted for caries control~     in young children or those with difficulty accessing and affording conventional dental care.~     The applicability of the findings and their impact on public health would be immense.~   "
51315|NCT02385461|"~     The occurrence of a spontaneous fetal loss (FL) is a rather frequent event: it has been~     estimated that up to 15% of pregnancies result in a fetal loss. However, recurrent events,~     defined as >2 or >3 loss, depending on the guidelines used (American College of~     Obstetricians and Gynecologists or Royal College of Obstetricians Gynaecologists~     guidelines), occur in 1 % of all pregnancies and it is noteworthy that Recurrent Fetal Loss~     ( RFL) in about 30-40% of cases remain unexplained after standard gynaecological, hormonal~     and karyotype investigations. Furthermore, it is important to consider that chromosomal~     abnormalities are responsible for at least 60% of FL in the first trimester, thus an~     abnormal karyotype in the fetus should be excluded prior to consider testing women for~     genetic susceptibility to placental vascular complications (inherited thrombophilia).~      Common inherited conditions, the factor V Leiden (FV) and the factor II G20210A (FII)~     mutations have been recognized as risk factors for FL.~      The efficacy of treatment with antithrombotic drugs during pregnancy in women with a history~     of RFL/ Intra Uterine Fetal Death (IUFD) and thrombophilia is still debated, due to scarcity~     of available data. Italian guidelines suggest the use of Low-Molecular-Weight Heparin (LMWH)~     in women with FV or FII mutations and previous otherwise unexplained obstetric~     complications, while guidelines released by RCOG suggest that heparin therapy during~     pregnancy may improve the live birth rate in women with second trimester loss associated~     with inherited thrombophilias. Hence, the idea to propose this prospective observational~     study comparing clinical data and outcomes in women with common inherited thrombophilias and~     in women without.~      During this study the investigators will collect and evaluate clinical data from~     examinations and visits by patients, eligible for the study as carriers of thrombophilic~     defects. This observation will begin before pregnancy and continue until the puerperium,~     allowing us to study all possible factors influencing these conditions. The study will add~     knowledge for improving feto-maternal prognosis and preventing spontaneous and recurrent FL.~      Plan of the study: multicenter observational study~   "
51316|NCT02385448|"~     The purpose of the study is to compare the recurrence of endometriotic cyst in patients~     taking Dienogest or Microgynon after conservative surgery.~   "
51317|NCT02385435|"~     The aim of this prospective randomized double-blind study was to compare the analgesic~     efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1)~     co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children~     undergoing infra-umbilical surgery.~   "
51318|NCT02385422|"~     To compare the efficacy and safety of Carvedilol and Propranolol in patients with~     cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary~     prophylaxis.~   "
51771|NCT02379481|"~     This study aims to elucidate the effects of deer bone extract NS on cognitive function~     improvement and its safety in healthy adults aged 40 to 65 years who report decline in~     subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.~   "
51321|NCT02385383|"~     This observational study follows a cohort of patients scheduled for elective hip- or knee~     surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to~     surgery according to a recently introduced standardized treatment protocol at 6 high-volume~     surgical centres.~   "
51322|NCT02385370|"~     Patients with advanced glaucoma that are candidates for trabeculectomy will be included.~      Thorough ophthalmic examination including best corrected visual acuity, slit lamp~     examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly~     microscopy will be performed for all participants. Patients will be assigned randomly to 2~     groups. In one group they will undergo fornix based trabeculectomy with conventional MMC~     0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected~     into the tenon at the beginning of the surgery. The rest of the operation is the same for~     both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement~     will be performed at one, 3 and 6th month post surgery. Specular microscopy will be~     requested at final follow up visit. Bleb morphology will be scored according to Indian~     grading system at 3rd and 6th months post surgery.~   "
51323|NCT02385357|"~     There is no conclusive evidence about the effect of intake of protein-enriched drink after~     and acute high intensity exercise bout on muscle function and damage. The investigators~     aimed to study the effect of a protein-enriched drink on muscle function recovery following~     an acute high intensity exercise bout. The present counterbalanced, crossover, and double~     blind study will involve a total of 12 active men.~   "
51324|NCT02385344|"~     The purpose of the registry is to collect information regarding the number and type of~     coronary artery bypass (CAB) surgical procedure changes that are made based on~     intraoperative guidance information using transit time flow measurements (TTFM) and~     ultrasound image capabilities provided with the Medistim device.~   "
51325|NCT02385331|"~     Neutrophils play a central role in innate immunity and are rapidly recruited to sites of~     infection and injury. Neutrophil apoptosis and necroptosis are essential for the~     inflammatory.This study is designed to investigate the cells and the molecular mechanisms of~     neutrophil necroptosis and apoptosis.~   "
51326|NCT02385318|"~     The purpose of this study is to compare safety and efficacy of Perrigo's drug product~     compared to an FDA approved drug product in the treatment of actinic keratosis.~   "
51327|NCT02385305|"~     The aim of this prospective study is to determine the effect of pressure support ventilation~     (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in~     anesthetized spontaneously breathing subjects by observing alterations of respiratory rate~     (RR), expiratory tidal volume, MAV and ETCO2 at variable levels of pressure support.~   "
51328|NCT02385292|"~     The objectives of this study are:~        -  To compare the change in levels of tear proteins and inflammatory mediators pre and~          post administration between the intranasal and extranasal applications~        -  To compare the goblet cell count following application between the intranasal and~          extranasal applications~        -  To compare fluorescein tear clearance with the application of the device intranasally~          and extranasally applications~   "
51329|NCT02385279|"~     The primary objective of this study is to compare the performance of MISTENT to that of~     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The~     patients will be followed through 3 years for major clinical events.~   "
51330|NCT02385266|"~     The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo~     treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).~   "
51331|NCT02385253|"~     This is a four-phase educational intervention for primary care practitioners (PCPs) to~     perform opportunistic melanoma surveillance. Based on prior research, the investigator will~     develop an interactive melanoma early detection skills training program for PCPs according~     to the principals of mastery learning. The proposed educational intervention will improve~     practicing PCPs' knowledge, competence, confidence, and diagnostic performance regarding~     pigmented lesions and attitude concerning importance of skin surveillance. In addition, this~     research aims to examine the clinical proficiency of PCPs regarding pigmented lesions. The~     proposed educational intervention will reduce the percentage of benign lesions referred to~     dermatology.~   "
51332|NCT02385240|"~     To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved~     rosacea drug product in the treatment of facial erythema of rosacea.~   "
51333|NCT02385227|"~     This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess~     exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu~     e-cigarette products. The primary objectives of this study are to:~        1. Compare changes in selected urine and blood biomarkers of tobacco exposure within~          cohorts following a 5-day forced-switch from usual brand conventional combustible~          cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the~          subject's usual brand combustible cigarette, or smoking cessation.~        2. Compare changes in selected urine and blood biomarkers of tobacco exposure among~          cohorts following a 5-day forced-switch from usual brand conventional combustible~          cigarettes to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the~          subject's usual brand combustible cigarette, or smoking cessation.~      The secondary objectives of this study are to:~        1. Compare changes in selected physiological endpoints affected by tobacco exposure within~          cohorts during a 5-day forced-switch from usual brand conventional combustible~          cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the~          subject's usual brand combustible cigarette, or smoking cessation.~        2. Compare changes in selected physiological endpoints affected by tobacco exposure among~          cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a~          blu e-cigarette and the subject's usual brand combustible cigarette, or smoking~          cessation.~        3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of~          blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand~          combustible cigarette over a 5-day period.~        4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu~          e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to~          smoke.~        5. Assess subject opinions of various characteristics of blu e-cigarettes.~        6. Assess the safety and tolerability of short-term use of blu e-cigarettes.~   "
51334|NCT02385214|"~     Patients with a primary invasive melanoma are recommended to undergo excision of the primary~     lesion with a wide margin. There is evidence that less radical margins of excision may be~     just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision~     of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm~     thick to determine differences in the rate of local recurrence and melanoma specific~     survival. A reduction in margins is expected to improve quality of life in patients~   "
51335|NCT02385201|"~     This is a prospective, multi-center feasibility study of effectiveness and safety of the~     Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data~     at follow-up visits will be compared to Baseline data collected at the beginning of the~     study.~   "
51336|NCT02385188|"~     The purpose of this study is to evaluate the efficacy, safety and immunological response of~     topical 5% imiquimod cream for non-invasive vulvar Paget's disease.~   "
51389|NCT02384499|"~     -  Purpose: The investigators aimed to investigate the safety and efficacy in the~          treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.~        -  Method~             1. Safety test of allogenic ASCs injection~             2. Efficacy test of allogenic ASCs injection~   "
84807|NCT01947335|"~     This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during~     the procedure.~   "
51337|NCT02385175|"~     The Eustachian tube links the middle ear to the back of the nose and is designed to open to~     allow the pressure in the air-filled middle ear to be equal to external (atmospheric)~     pressure. In some people this system fails to work properly leading to abnormal pressure in~     the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear~     drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'.~     An affected person may feel pressure, pain or other symptoms in their ear, and their hearing~     can be temporarily or permanently reduced.~      This study is designed to find out which of a number of simple tests is best at detecting if~     the Eustachian tube is performing normally. Both patient-completed questionnaires and~     clinical tests using specialist machines will be compared as a way of diagnosing Eustachian~     tube dysfunction.~      A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a~     similar group of people that are already known to have Eustachian tube dysfunction, will~     both take six different tests and complete four different questionnaires. The differences in~     the results between the group with ETD and the healthy group will be compared. The results~     for each test or questionnaire will be compared to see which is best at telling the healthy~     and Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube~     dysfunction. The investigators will also look to see if a combination of one or more of the~     tests or questionnaires is best at diagnosing the disease.~      The results of this study hope to provide a test or combination of tests that can be used on~     a daily basis by ENT doctors. The assessment technique would also be helpful in researching~     and comparing new treatments for ETD.~   "
51338|NCT02385162|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Glycogen~     Storage Diseases from plasma and saliva. Testing for clinical robustness, specificity and~     long-term stability of the biomarker.~   "
51339|NCT02385149|"~     This study investigates the health benefits of whole grain wheat on cardiovascular/~     cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal~     challenge. This study also investigates the health benefits of whole grain wheat (WGW) on~     liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices~     in quantifying health effects in a nutritional intervention study.~   "
51340|NCT02385136|"~     The purpose of this study is to evaluate the safety profile and efficacy of whole brain~     radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases~     (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant~     TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).~   "
51341|NCT02385123|"~     This is an open label single arm observational study of longitudinal immunologic responses~     to influenza vaccine in healthy adult subjects. This study will enroll males and~     non-pregnant females, 18-49 years old. The subjects will be screened at enrollment with a~     history and physical exam and laboratory testing to ensure they are healthy enough to~     participate. Qualifying subjects will be vaccinated with an FDA approved seasonal~     inactivated influenza vaccine (IIV) according to the package insert. The study will enroll~     10 healthy volunteers per vaccination season in years 1, 2 and 4 through 6 of this study,~     for a total enrollment of 50 subjects. The primary objective of the study is to characterize~     HA-specific plasmablasts and memory B cells after influenza vaccination.~   "
51342|NCT02385110|"~     The goal of this clinical research study is to learn the if the drug combination of~     alemtuzumab, etoposide and dexamethasone can help to control HLH. The safety of the drug~     combination will also be studied.~   "
51343|NCT02385097|"~     This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference~     product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for~     distal upper limb surgeries, without any supplementation in the first 45 min (see~     definitions below), calculated from the time of readiness for surgery (complete sensory~     block). Successful block: anaesthesia adequate for the surgery (complete sensory block),~     without any supplementation in the first 45 min (even if surgery lasts for > 45 min),~     calculated from the time of readiness for surgery (complete sensory block). Supplementation:~     i.v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or~     additional local anaesthetic infiltration~   "
51344|NCT02385084|"~     The purpose of this study is to measure how much of the new LY2409021 tablet formulations~     get into the blood stream and how long it takes the body to get rid of them, compared to the~     current LY2409021 capsule formulation. In addition, the safety and tolerability of both the~     new and current formulations will be evaluated. Information about any side effects that may~     occur will also be collected. The study has two parts. Each participant may enroll in one~     part only. The study will last up to 8 weeks for each participant. Screening is required~     prior to the start of the study.~   "
51345|NCT02385071|"~     The purpose of this study is to assess the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of simeprevir (SMV) following single~     dose administration of age-appropriate oral formulation candidates compared to the 150~     milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV~     following single dose administration of a selected age-appropriate oral formulation~     candidate.~   "
51346|NCT02385058|"~     The purpose of this study is to assess the efficacy and safety of the combination of~     mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in~     Mexican population.~   "
51347|NCT02385045|"~     This study aims to assess whether iScan, an intra-endoscopic imaging technique is an~     accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori)~     and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow~     band imaging (NBI) and histology.~   "
51348|NCT02385032|"~     The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.~   "
51349|NCT02385019|"~     Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host~     disease after an allogeneic transplant of hematopoietic progenitors with donor~     CliniMACS-selected regulatory T cells~   "
51400|NCT02384356|"~     The purpose of the study is to gather baseline surveillance data about the current health~     status of adults with chronic health conditions in La Paz and El Alto, Bolivia and identify~     barriers to the management of NCDs during face-to-face outpatient encounters as well as via~     novel mobile health services.~   "
51772|NCT02379468|"~     The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in~     the healing of foot ulceration in diabetic patients.~   "
51350|NCT02385006|"~     Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization,~     no modifications of the usual care, study results are not available for the physicians in~     charge of the patient.~      Objectives:~        -  The main objective of this study is to evaluate the ability of the thromboelastogram~          (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation,~          comparing ROTEM ® profiles during the perioperative period of two different types of~          transplantation (kidney alone and simultaneous pancreas-kidney)~        -  The secondary objectives are:~             1. To assess the incidence and type of coagulation disorders during the perioperative~               period of these two types of transplantation~             2. To study correlation values between thrombolelastogram and standard coagulation~               parameters~      Population study:~        -  Evaluated group: 40 pancreas-kidney recipients~        -  Control group: 80 kidney recipients~        -  Recruitment periods: 24 months~        -  Patient Monitoring: 48 hours~        -  Total duration of the study: 36 months.~        -  Ethics: Study of routine care. Oral and written information given to patients.~          Validation of the study protocol by the local ethics committee (CPP Sud Est II:~          Protocol No. HCL / P 2012.727)~   "
51351|NCT02384993|"~     The purpose of the aeRobic Exercise and Cognitive Health (REACH) study is to understand how~     an aerobic exercise intervention might help promote brain health and cognition, thereby~     delaying the onset of clinical symptoms of Alzheimer's disease.~   "
51352|NCT02384980|"~     This study will take the first step to improve public health for millions of Americans with~     Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The~     investigators will assess a proof of concept, home administered, functional electrical~     stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.~   "
51353|NCT02384967|"~     Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in~     HIV-1 infected patients virologically suppressed under a once daily regimen including~     darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain~     the viral load lower than 50 copies / mL at 48 weeks of treatment.~   "
51354|NCT02384954|"~     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in~     conjunction with rituximab.~   "
51355|NCT02384941|"~     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin High dose~     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when~     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate~     glycemic control with insulin therapy.~   "
51356|NCT02384928|"~     This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for~     severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with~     usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty~     patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6~     months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture,~     acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2~     sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care~     group will receive conventional medication 2 times/day and 2 sessions/week of physical~     therapy. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after~     randomization.~   "
51357|NCT02384915|"~     The aim of the study is to compare the time of home discharge in day-case patients receiving~     either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy~   "
51358|NCT02384902|"~     low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared~     with conventional diet.~      low GL may have more favorable effect than low GI diet.~   "
51359|NCT02384889|"~     This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase~     1 clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study~     enrolling patients with new onset type 1 diabetes with documented continued residual~     C-peptide production. After a 4 week screening and run-in period during which eligibility~     will be determined and glycemic control optimized, subjects will have a 3-month~     double-masked treatment period with either DFMO or placebo. After a 3 month wash-out period~     the durability of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3~     to placebo in each cohort) to 1 of 4 sequential dose cohorts.~   "
51360|NCT02384876|"~     The incidence of arterial hypotension under general anesthesia using sevoflurane is~     particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the~     initial mean blood pressure (mBP) is the definition of significant arterial hypotension in~     adults and children. In adults, intraoperative arterial hypotension is associated with an~     increase of intraoperative mortality and a certain neurological morbidity. In infants under~     6 months of age, neurological disorders have been reported following general anesthesia.~     Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial~     hypotension.~      Current management of hypotension uses vascular filling with crystalloids and vasopressive~     amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also~     be used. Ephedrine is particularly interesting because of its action on both α and β~     receptors and its mode of administration: one dose and peripheral access.~      Only one study is available in children from birth to adulthood; it demonstrates a lower~     hemodynamic response in infants than in adults, when administered a low dose of Ephedrine~     (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses~     and the use of higher doses than those recommended.~      The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine~     associated with a difference of proportion of newborns/infants in therapeutic success of~     55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative~     arterial hypotension.~      Secondary objectives:~        -  Return to a mBP superior to 38mmHg post Ephedrine administration.~        -  To assess occurrence of hypoxemic events during anesthesia.~        -  To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6~          months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24~          months.~   "
51361|NCT02384863|"~     The purpose of this study is to describe the characteristics, evaluation, management and~     outcomes of acute chest pain, and to provide opportunities for future initiatives to improve~     the emergency care for patients experiencing acute chest pain in China.~   "
51362|NCT02384850|"~     This trial will evaluate the combination treatment of established chemotherapy regimen~     mFOLFOX6 with Selinexor, an oral Selective Inhibitor Of Nuclear Export, in patients with~     metastatic Colorectal Cancer. The purpose is to determine the maximum tolerated dose (MTD)~     of selinexor in combination with mFOLFOX6.~   "
51401|NCT02384343|"~     The purpose of this study is to determine whether dexmedotomidine is effective in the~     treatment of shivering associated with neuraxial anesthesia during cesarean delivery.~   "
61924|NCT02246686|"~     The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in~     patients with mild to moderate ulcerative colitis in an acute flare.~   "
51363|NCT02384837|"~     Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared~     with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this~     technology, has emerged as a major concern. Researches indicated incomplete neointimal~     coverage of stent struts as the most important morphometric predictor of LST. Pathological~     research showed stenting disruption of adjacent vulnerable plaques can precipitate LST,~     Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse~     Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which~     are prone to LST in vivo.~      Optical coherence tomography (OCT)is a high-resolution (<10 µm), catheter-based imaging~     modality capable of investigating detailed coronary plaque morphology in vivo.This study~     aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts~     on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable~     polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT~     and FFR~   "
51364|NCT02384824|"~     The purpose of this study is to characterize the plaque morphology in patients with acute~     STEMI by OCT after aspiration thrombectomy.~   "
51365|NCT02384811|"~     The primary object of this trial is to evaluate the 2-year local control rate adding~     extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell~     carcinoma.~   "
51366|NCT02384798|"~     Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced~     functional capacity, evidenced during usual daily activities and exercises. The Cardiac~     Rehabilitation with emphasis on resistance and aerobic exercises performed in the same~     session (concurrent training), can be added to pharmacological treatment as improvement~     strategy in functional capacity and quality of life.~   "
51367|NCT02384785|"~     Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In~     recent years many studies had proved the effectiveness of electrical stimulation in pain~     management, tissue healing and muscle strengthening. Today there are devices with many types~     of currents. Each current comes with different statements for its effectiveness and its~     penetration depth yet there is no consensus on the most effective current in the dimension~     of penetration depth.~   "
51368|NCT02384772|"~     Survey to assess perspectives of patients prescribed IOP-lowering eye drops at a single~     office visit.~   "
51369|NCT02384759|"~     This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for~     strategic studies evaluating the usefulness of including targeted therapeutics from the~     first line with aflibercept +/- LV5FU2.~   "
51370|NCT02384746|"~     Participants in this study will have been diagnosed with advanced breast cancer that has~     become worse while being treated with fulvestrant. Participants will have estrogen-receptor~     positive disease, and have completed menopause.~      There is information from research labs which suggests that drugs that work like MLN9708~     help kill breast cancer cells that have been treated with fulvestrant. The purpose of the~     study is to determine the proper dose as well as the good and bad effects of MLN9708 when it~     is given in combination with fulvestrant. The Investigators also want to learn more about~     how the drug combination affects tumor cells.~      The amount of MLN9708 participants receive will be determined by when they enter this study.~     Three different doses will be given to different participants. The Investigators expect to~     enroll a total of 12-18 people.~   "
51371|NCT02384733|"~     The purpose of the study is to investigate the difference in late radiation morbidity~     between hypofractionated and normofractionated loco-regional breast irradiation irrespective~     of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be~     provided as a simultaneous integrated boost.~   "
51372|NCT02384720|"~     The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship~     between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG,~     EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.~   "
51373|NCT02384707|"~     Reintroduction of small doses of food in allergic children to lightening the elimination~     diet.~   "
51374|NCT02384694|"~     The aim of this study is to examine the effects of a 12-week Zumba dance intervention on~     fitness, anthropometric and psychometric parameters and eating behavior.~   "
51375|NCT02384681|"~     Auditory monitoring of employees is currently based on pure-tone audiometry. However, this~     clinical examination does not prevent from deafness but established it a posteriori. From a~     preventive standpoint, it is important to detect hearing professional pain before the~     development of irreversible(s) clinical(s) symptom(s). The investigators' hypothesis is that~     auditory fatigue results from damages of primary and secondary central auditory pathways~     involving cognitive processes.~      The assessment of auditory fatigue includes the evaluation of speech intelligibility,~     short-term memory, working memory and perceived mental task load. The main objective of this~     study is to identify, among regulating medical assistants working with headset, a central~     auditory fatigue.~   "
51376|NCT02384668|"~     The purpose of this study is to investigate the effects of vitamin D supplementation on~     morbidity and risk of relapse in patients with Graves' disease.~   "
51377|NCT02384655|"~     Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal~     intensive care unit acquired morbidity such as NEC and the late onset sepsis.~      It is often difficult to obtain sufficient quantities of human milk from mothers of preterm~     infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use~     galactogogues in an attempt to increase milk production. Fenugreek (Trigonella~     foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the~     pea family. Our experience at the NICU is that around 30% of preterm mothers desperately~     looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe)~     as food supplement. Although widely recommended, there is limited evidence to support the~     effectiveness of fenugreek as a galactogogue.~      The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has~     any effect on macronutrients composition of breast milk and whether fenugreek is transferred~     to the infant via mother milk. In addition any changes in mother and infant health status~     will be assessed.~   "
51440|NCT02383836|"~     Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD)~     performed and a comparison of timing, sensitivity and intensity of intravenously injected~     bubbles will be determined.~   "
51378|NCT02384642|"~     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls~     in Eastern Democratic Republic of Congo. The study design will employ a two-arm randomized~     controlled trial where girls will be enrolled at the same time and randomized to receive a~     basic package of services, which includes life skills education and access to mentors in~     safe spaces, or the basic package plus a structured parenting intervention for girls'~     caregivers. An experimental design will be used to evaluate the relative impact of the~     parenting initiative in addition to the safe space program for girls. In addition,~     qualitative research will address additional questions of acceptability, processes of change~     and best practice.~      Groups in North and South Kivu will be randomized so that every group is randomly designated~     as a group that will either roll out the core intervention or the intervention plus~     caregiver component. Groups that do not receive the parental intervention during the study~     will receive the intervention when the study is complete to reduce communal jealousies.~      The intervention, the COMPASS program, will involve a structured intervention for girls~     between the ages of 10-14 that is intended to engage adolescent girls, those who are~     influential in their lives, service providers and other stakeholders, with the ultimate goal~     of co-creating environments in which girls are valued and safe. The program is centered on~     establishing or supporting community-supported safe spaces for girls where they can come and~     gather among themselves and participate in a structured life-skills curriculum. In addition~     to the safe spaces for girls, the COMPASS project will also implement structured activities~     for the parents and caregivers of participants.~   "
51379|NCT02384629|"~     1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients~          with coronary artery bifurcation disease~        2. To assess the impact of optical coherence tomography (OCT) guidance on clinical~          outcomes following the stent type~   "
51380|NCT02384616|"~     This study is aiming at assessing the effect of inspired oxygen fraction during general~     anesthesia on children's lung mechanics and volume. More specifically, the temporal change~     in end-expiratory lung volume (EELV) and respiratory system resistance and elastance during~     the perioperative period will be characterized in order to define the the effect of high~     inspired fraction of oxygen on lung function.~   "
51381|NCT02384603|"~     The aim of this study is to compare the effects of two physiotherapeutic treatments of~     fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and~     segmental muscle stretching exercises associated with cognitive behavioral therapy.~   "
51382|NCT02384590|"~     Patients with sickle cell disease (SCD) experience significant depressive symptoms that~     currently go unrecognized and under-treated. Further, depression in this patient population~     has the potential to contribute to high health care utilization and poor disease outcomes;~     however, there are currently no comparative effectiveness studies of evidenced-based mental~     health treatments for depression in SCD.~      The primary objective of this study is to test the effectiveness of an online computerized~     cognitive behavioral therapy intervention to address psychological and behavioral needs of~     patients with sickle cell disease, namely depression and pain symptoms. The investigators~     will implement an existing computerized cognitive behavioral therapy (CCBT) program called~     Beating the Blues into routine clinical care at the University of Pittsburgh Medical~     Center (UPMC) Adult Sickle Cell Clinic to determine the effectiveness of this intervention~     in decreasing depression and pain versus treatment as usual. Patients with significant~     distress—depression and/or anxiety symptoms—will be randomized to either eight sessions of a~     CCBT program and weekly follow-up with a care manager or treatment as usual where the~     treating physician is notified of the patient's symptoms. The investigators will evaluate~     patient acceptability, implementation and practicality of the online mental health~     intervention through patient use of the site (frequency and duration of visits), qualitative~     interviews, and surveys. The investigators hypothesize: 1) the CCBT will be an acceptable~     mental health treatment for patients and easily integrated into routine clinical care; 2)~     patients in the treatment arm will show a greater decrease in depression/anxiety symptoms~     and average daily pain than patients in usual care.~   "
51383|NCT02384577|"~     The main aim of the study is to investigate patient satisfaction in the treatment of asthma~     and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible~     difficulties in the use of the device under real-life conditions in clinical practice are~     investigated.~   "
51384|NCT02384564|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct~     Laryngoscopy in Children.~   "
51385|NCT02384551|"~     4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on~     gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.~   "
51386|NCT02384538|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to compare the~     safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.~   "
51387|NCT02384525|"~     Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of~     critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI~     are widely treated with Continuous renal replacement therapy (CRRT). However, previous~     studies have hardly documented improvement of mortality in septic AKI patients. Otherwise,~     Fluid overload in septic shock patients who are undergoing CRRT is proven to be a~     significant predictor for mortality. Recent studies showed efficacy of bioelectrical~     impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus,~     hypothesis of the study is that fluid assessment and control of fluid status using BIA and~     Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In~     this study, the investigators measure the fluid status of the patients by bioelectrical~     impedance analysis and lung ultrasound for experimental group, while for control group,~     fluid status would be determined clinically by the physician. Ultrafiltration rate of~     experimental group is adjusted to be equal to the value of overhydration measured by BIA.~   "
51388|NCT02384512|"~     End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and~     non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with~     the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for~     therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations~     significantly in combination therapy with L-dopa and other parkinsonian medication.~   "
51390|NCT02384486|"~     This study aims to reduce stress in mothers of children with autism in Saudi Arabia. The~     researcher has designed a training programme for mothers whose children are young and just~     in their early stage at the autism organisations they are attending. The programme will~     include stress reduction tips, behavioural modification strategies for children with autism,~     and financial resources available to parents (how they can access government funding). The~     study will have two parts. Part one involves conducting an experiment by dividing the~     participants into two groups, one group will receive the training and the other group will~     wait until the end of the study then they will also receive the same training. Both groups~     will fill questionnaire at the beginning of the study, then after the first group finishes~     training, and then again 6 weeks later. Part two of the study will involve interviewing~     mothers of the first group who attended the training session. They will be interviewed by~     the researcher asking them about their experience with the training programme and their~     suggestions for future improvements. Mothers will be given a training manual at the~     beginning of the training. Training involves attending five sessions, one of which is a face~     to face session at the autism organisation their children are attending and the other four~     sessions will be through a Smartphone application called whatsapp which is widely used in~     Saudi Arabia.~   "
51391|NCT02384473|"~     This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave~     elastography in predicting treatment response in patients with soft tissue sarcomas.~     Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make~     pictures of the body without using radiation (x-rays). Real-time contrast-enhanced~     ultrasonography and shear wave elastography may help measure a patient's response to~     treatment given before surgery in patients with soft tissue sarcoma.~   "
51392|NCT02384460|"~     The aim is to assess the efficacy and safety of SD-101-6.0 cream versus SD-101-0.0 (placebo)~     in the treatment of patients with Epidermolysis Bullosa.~   "
51393|NCT02384447|"~     The investigators are proposing to conduct this study to compare the ultrasonographic~     appearance of the sciatic nerve with their corresponding histologic architecture. Patients~     that are scheduled to undergo above knee amputation due to complications associated with~     diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at~     its bifurcation (about 4 inches above the knee). The investigators would mark the area on~     the skin where the image is obtained. Following surgery we will conduct a histologic~     examination of the nerve at the same site.~      Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and~     does not add any risk to the subject. Histologic examination of the nerve is also not~     standard of care, but is conducted on a pathology specimen~   "
51394|NCT02384434|"~     This single-arm phase I/II study establishes the safety and efficacy of low level laser~     therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing~     radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives~     include assessment of patient-reported quality of life data, pain parameters and~     dermatologic quality of life responses. The target population is patients with~     histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or~     larynx who are candidates for either definitive or adjuvant therapy consisting of a~     chemotherapy regimen and concurrent radiation therapy.~      Patients are required to have a favorable performance status (KPS greater than or equal to~     70), have had no prior head and neck radiotherapy and be at least 18 years of age and able~     to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients~     will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least~     nine treatment sites in the head and neck region for a duration of 60 seconds to each site.~     LLLT will be given three times in a week prior to, daily during the first week of, and at~     least twice weekly thereafter during radiotherapy.~      Information collected includes toxicity scoring and quality of life surveys. A retrospective~     matched-pair design will be used to assess the rate of grade III complications compared to~     patients treated previously without LLLT support, with an anticipated 20% reduction in the~     risk of grade III dermatitis.~   "
51395|NCT02384421|"~     Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs~     in Parkinson's disease. Currently, cDBS is limited to open-loop stimulation, without~     real-time adjustment to the patient's state of activity, fluctuations and types of motor~     symptoms, medication dosages, or neural markers of the disease. The purpose of this study is~     to determine if an adaptive DBS system,responding to patient specific, clinically relevant~     neural or kinematic feedback, is more effective than continuous DBS on the motor Unified~     Parkinson's Disease Rating Scale (UPDRS III) and specific phenotypic measures in Parkinson's~     Disease.~   "
51396|NCT02384408|"~     Healthy postmenopausal women, amenorrheic for 1-10 years, aged 45-60 years and in use of~     follicle stimulating hormone > 30 mille-International unit/milliliters (mIU/mL), will~     participate in the study.~      All women will be informed by a physician of the risks and possible benefits of Hormone~     Replacement Therapy (HRT).~      The continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg or tibolone~     1.25 mg will be administered for a 24-week period.~      Transvaginal ultrasound was performed to evaluate the thickness of the endometrium at~     baseline. At study end-point, an endometrial biopsy will be performed with a Pipelle~     endometrial sampler to examine histological and immunohistochemical parameters.~      Immunohistochemical detection of Bcl-2 protein, estrogen and progesterone receptors will be~     performed in stroma and glandular epithelium.~   "
51397|NCT02384395|"~     This is a multicenter, single arm, 96-week open-label study of the safety and virologic~     efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC)~     initiated during acute HIV infection (AHI).~   "
51398|NCT02384382|"~     The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography /~     computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response~     in metastatic bone lesions in patients who are receiving enzalutamide for~     castration-resistant prostate cancer.~   "
51399|NCT02384369|"~     This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects~     with cPTSD, added to pre-existing treatment that includes prazosin with or without other~     psychotropic drugs.~      Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8~     weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress~     disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared~     with the response to placebo.~   "
51402|NCT02384330|"~     This study aims to estimate the costs of botulinum toxin A utilization in standard practice~     for the treatment of upper limb spasticity post-stroke in Portugal.~      It will consider the three most used locally available brands of botulinum toxin A which~     show similar efficacy and safety profiles thus making it relevant to understand if choosing~     between one or another brand can depend directly on economic factors.~      The study will estimate direct and indirect drug-associated costs as determinant variables~     for the price of each drug and the standard drug dose used in clinical practice.~   "
51403|NCT02384317|"~     This is a pilot study to test safety, tolerability, and efficacy of CCX168 in reducing~     proteinuria in patients with Immunoglobulin A nephropathy and persistent proteinuria despite~     supportive therapy with a maximally tolerated RAAS blocker.~   "
51404|NCT02384304|"~     The purpose of this study was to determine whether a 10-week internet-based program based on~     cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if~     having therapist guidance leads to greater effects.~   "
51405|NCT02384291|"~     This clinical study is designed to compare the regenerative outcome of using separately two~     different Xenografts during sinus floor augmentation.~      Aim of this prospective randomized-controlled clinical trial is to compare the regenerative~     results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft~     after two-step sinus floor elevations by clinical and histological analysis.~      Clinical Parameters are wound healing parameters, radiological volume stability and implant~     survival rates. Histological parameters are based on a histomorphometrical analysis of~     trephine cores harvested in progress of implant bed preparation.~   "
51406|NCT02384278|"~     The purpose of this study is to determine whether internet based cognitive behavior therapy~     might be effective in the treatment of alcohol problems.~   "
51407|NCT02384265|"~     Diabetes is a major public health problem that is associated with substantial health~     disparities for African American women compared to African American men or white men and~     women. This project will incorporate a) new technology whose use is high among African~     Americans (cell phone text message reminders), b) support from social networks, and c)~     strategies from the emerging field of behavioral economics to encourage and support self~     care behaviors that lead to improvements in diabetes control.~      In Stage I of the study, the investigators conducted focus groups with women with diabetes~     and their family members and friends. The investigators used information from these groups~     to work with a team of community partners to develop recruitment protocols, prepare study~     documents (including flyers, Frequently Asked Questions sheets, and informed consent forms),~     and finalize participant surveys.~      In the next phase of the study the investigators will evaluate ways that friends and family~     members can use direct support and text messages to improve control of blood sugar for~     African American women with type 2 diabetes. A team of three people--the Person With~     Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members~     (STMs)--will be assigned at random to one of two groups to compare approaches to improving~     control of blood sugar. Each team will receive information and resources on improving~     diabetes control and will be linked by a text messaging program. The intervention team will~     receive additional text messaging support that may help them improve the PWD's diabetes~     control.~   "
51408|NCT02384252|"~     The investigators aim to explore obese cardiomyopathy by studying contractile twitch force,~     sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of~     patients grouped according to their body mass index, i.e. normal weight, overweight and~     obese.~   "
51409|NCT02384239|"~     Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients~     will receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or~     tamoxifen (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical~     menopause.~      Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive~     palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks.~     Therapy will be continued until PD or unacceptable toxicity.~      Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of~     palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by~     our collaborating statistician at Dana-Farber Cancer Institute.~   "
51410|NCT02384226|"~     Refine content and delivery of the mHealth delivered lifestyle intervention program through~     iterative testing with small groups of users who provide feedback through on-line~     asynchronous focus groups.~   "
51411|NCT02384213|"~     The main objectives of this study are: i) to investigate the incidence and prevalence of~     fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its~     evolution over time in men and in women; ii) to identify prognostic factors for developing~     HF in patients who had an MI.~   "
51412|NCT02384200|"~     When patients are going to have surgery to remove large kidney stones (percutaneous~     nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of~     prophylactic preoperative oral antibiotics; currently both the use of prophylactic~     preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be~     within standard-of-care.~      This study will randomize patients to preoperative prophylactic antibiotics or no~     antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the~     postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that~     started in the urinary tract (sepsis or urosepsis).~   "
51413|NCT02384187|"~     The frequent incidence of postoperative vomiting and severe pain in children undergoing~     adenotonsillectomy, may delay postoperative oral intake and increase the risk of~     dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this~     group of patients, with a reported incidence ranging from 23% to 73%.~      There is growing evidence that the perioperative administration of gabapentinin in adults is~     beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative~     nausea and vomiting, and delirium.~      Only few studies in literature explored the analgesic effects of preoperative gabapentin as~     premedication in pediatric population. However, the antiemetic effect of gabapentin in~     pediatric patients was not systematically investigated before.~   "
51538|NCT02382627|"~     This study plans to learn more about the thickness of the choroid in patients with optic~     neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to~     the outer layers of the retina. Patients are being asked to be in this research study~     because they have optic neuropathy and are receiving care at the University of Colorado~     Hospital.~   "
51414|NCT02384174|"~     The development of preventative nutritional strategies to promote healthy ageing is becoming~     increasingly important. Elevated thresholds for taste and smell, coupled with swallowing~     difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets~     among the elderly. This can induce great changes in the composition and metabolic activities~     of the gut microbiome, leading to decreased intestinal motility and impaired bowel function.~     This can result in constipation or diarrhoea, increased basal levels of inflammation,~     immunosenescence and morbidity. The objectives of this study are to use dietary modification~     to improve gut health in older people. Diets high in resistant starch or dietary fibre will~     be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised~     double-blind cross-over study. The aim is to investigate the effects on microbiome~     composition and functionality through fermentation, reduced putrefaction, and modification~     of blood markers associated with obesity and diabetes.~   "
51415|NCT02384161|"~     Isometric handgrip exercises are used to explain the effects of fatigue on the strength and~     activation of the muscles involved. Blood flow available at the time of exercise can~     influence this fatigue process, as some studies demonstrate changes in the pattern of muscle~     recruitment and strength recovery when the exercise is performed in combination with an~     external total obstruction (through a pressure cuff or tourniquet ) blood flow. Low~     intensity exercises associated with external partial obstruction of blood flow has been~     widely used and studied, mainly due to its effect on increasing strength and muscle~     hypertrophy, often comparable to those observed in conventional exercises (ie, without~     external obstruction of blood flow) High intensity. Despite the vast literature on this~     method, some topics need to be better informed about the underlying neuromuscular physiology~     to such effects (strength and hypertrophy) and the process of fatigue during isometric~     exercises associated with partial obstruction of blood flow. The aim of this study is to~     evaluate the acute effects on neuromuscular response in healthy adults undergoing an~     intermittent isometric exercise protocol with different levels of external compression. In a~     study of the crossover male volunteers will be submitted to three intermittent isometric~     exercise protocols (with a load of 45% of maximum voluntary isometric strength) associated~     with three different levels of obstruction (held by a pressure cuff) blood flow (total~     obstruction, partial obstruction and free blood flow). The protocols will be performed on~     three different days (with a minimum of 48 hours between them). Will be considered as acute~     neuromuscular responses spending time to failure in the task, the electromyographic activity~     of the flexor muscles of the wrist and fingers, and the recovery curve of maximum voluntary~     isometric strength after exercise. The main hypothesis of this study is that exercise is~     performed when associated with partial obstruction of blood flow, the time spent until the~     failed job is similar to that seen when exercise is performed with free blood flow, and the~     recovery of strength and electromyographic activity will be similar to that observed in the~     exercise associated with total obstruction of blood flow.~   "
51416|NCT02384148|"~     The investigators aimed to characterize human circadian clockwork in healthy individuals in~     comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental~     approach allowing the study of circadian profile in human individuals.~   "
51417|NCT02384135|"~     Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis~     (DVT)~   "
51418|NCT02384122|"~     The purpose of this study is to determine whether long-acting octreotide is effective in the~     treatment of patients with refractory anaemia due to angiodysplasias.~      The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron~     infusion requirements in those patients.~   "
51419|NCT02384109|"~     This proposed project will translate evidence-based strategies for diabetes prevention~     within the framework of an existing and highly utilized pharmacist-led diabetes care~     program. Our team includes investigators and practitioners with experience in implementing~     the DPP (Diabetes Prevention Program) as well as in community-based research. This proposal~     represents an opportunity to rapidly implement an innovative project addressing a critical~     area of significant unmet need, as the required key health system and community~     infrastructure are already in place. The intended outcome is the creation of a practical,~     effective and sustainable approach to increase evidence-based diabetes prevention strategies~     that can readily be adopted in other systems.~   "
51420|NCT02384096|"~     The study is a prospective, on-label, multi-center, blinded, randomized controlled trial~     with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's~     programming features and lead options.~   "
51421|NCT02384083|"~     Phase I/II, Multicenter, Open Label, Clinical Trial to evaluate safety and efficacy and~     determine the Maximum Tolerated Dose (MTD) of Filanesib in combination with pomalidomide and~     dexamethasone in relapsed/refractory (R/R) Multiple Myeloma (MM) patients~   "
51422|NCT02384070|"~     Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR~     calculation, no study has evaluated the optimal anti-thrombotic regimen in patients~     undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy~     for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a~     simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with~     aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in~     patients with intermediate coronary artery stenosis undergoing FFR calculation during~     elective coronary angiography.~   "
51423|NCT02384057|"~     C8 sciences program is a cognitive training program mainly developed for the students, and~     the effectiveness is well established. The aim of this trial is to assess clinical efficacy~     of the program for cognitive rehabilitation of the patients with stroke or brain injury.~   "
51424|NCT02384044|"~     This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip~     on existing dentinal hypersensitivity compared to a marketed sensitivity pen.~   "
51425|NCT02384031|"~     Post-dural puncture headache (PDPH) is the most common complication following lumbar~     puncture (LP). The frequency varies widely depending on a number of factors, among which~     patient characteristics, case ascertainment, gauge and type of needle used are of~     significant importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who~     were subjected to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle~     suffered post-dural puncture headache, while over 24 % of 115 who were given a lumbar~     puncture with a 22 gg traumatic needle suffered a headache. This finding provided the basis~     for an American recommendation to use a 22 gg atraumatic needle for diagnostic lumbar~     puncture. A later study with 58 patients has shown an even greater difference (36 % versus 3~     % post-dural puncture headache) when an atraumatic needle is used. Despite these findings,~     European Neurologist continue to hold on to the cutting needle. Here the investigators~     propose a prospective randomized study design with double masking; neither patient nor~     evaluator of PDPH aware of the needle design used, and with an active ascertainment of the~     occurrence of PDPH in accordance with updated headache classification guidelines. The~     investigators also intend to investigate whether specific neuroinflammatory substances and~     metabolites (different outcome variables) in the cerebrospinal fluid (CSF) will affect the~     explanatory variable.~   "
51989|NCT02376647|"~     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a~     driving pressure limited mechanical ventilation strategy compared to a conventional strategy~     in patients without acute respiratory distress syndrome (ARDS).~   "
51426|NCT02384018|"~     The purpose of this study is to show safety and tolerability to our mesenchymal stromal~     cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic,~     human component expansion media (pooled human platelet lysate) and delivered fresh.~     Subsequently, the investigators intend to test whether infusion of MSCs immediately after~     islet autograft can reduce onset of diabetes and improve glycemic control after total~     pancreatectomy and islet autotransplantation.~   "
51427|NCT02384005|"~     There is no standard screening protocol for anal cancer even as disease incidence increases.~     This single-visit study will clarify if single persons can do a self-digital anal exam, or~     perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for~     reasons of safety, accuracy, or acceptability.~      The investigators hypothesize that men having sex with men's digital anal exam (DAE)~     findings will have moderate or substantial agreement with a nurse practitioner DAE for~     detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant~     tumors). As a secondary hypothesis the investigator believe a partner-assisted DAE conducted~     within a couple will have better agreement with the nurse practitioner DAE than will a~     self-DAE conducted by a single person.~   "
51428|NCT02383992|"~     The primary objective of this study is to compare the efficacy of hydrogen peroxide versus~     normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to~     standard of care hydrogen peroxide or standard of care normal saline in postoperative care~     of sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will~     be collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating~     (0-4) with 0 being none/absent and 4 being severe/extreme.~   "
51429|NCT02383979|"~     Mirror therapy will consist of observing the unaffected limb reflected in a mirror~     positioned in the midline to block the view of the affected limb. All therapy sessions will~     be supervised by a physical therapist with the exception of weekends when the patients will~     continue therapy on an independent basis. In an effort to objectively demonstrate cortical~     reorganization associated with mirror therapy, patients can elect to participate in a~     functional MRI (fMRI) portion of the study. The fMRI would be evaluated prior to initiating~     the experimental or control therapy (Due to the sensitive timeline in this population and~     its effect on recruitment, we have amended the protocol to allow recruitment and enrollment~     to take place even if the timeline does not allow for the fMRI to be executed 2 weeks prior~     to amputation. Though this would be ideal, we will accept subjects that are only available~     for day before amputation scans), just before the operative procedure, at four weeks~     post-operation and then again at one year. All subjects will be evaluated at 4 weeks, 8~     weeks (functional physical therapy (PT) tests only) 12 weeks, and 12 months postoperatively~     to determine 1) the incidence, severity and functional impact of phantom limb pain 2)the~     ability to meet various specialists' endpoints, to include participation in physical~     therapy, and 3) overall quality of life which the patients can describe subjectively. This~     therapy could have a dramatic impact on the long term prognosis of amputees whether due to~     trauma, metabolic conditions, tumor, or peripheral vascular disease.~      This protocol will include performing fMRIs on a cohort of healthy, active duty, age~     matched, male personnel to create reference data to compare the fMRI data of study~     participants.~   "
51430|NCT02383966|"~     This trial aims to assess efficacy and safety of cetuximab when given in combination with~     chemotherapy compared with chemotherapy alone in Chinese subjects with recurrent and/or~     metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.~   "
51431|NCT02383953|"~     This study aims to investigate the role of non-genetic factors in the pathogenesis of~     inflammatory bowel disease.An exploratory study to investigate differences between the~     epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel~     disease.~   "
51432|NCT02383940|"~     This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on~     A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on~     their current insulin regimen.~   "
51433|NCT02383927|"~     Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in~     subjects with advanced tumors that carry HRAS mutations and for whom there is no standard~     curative therapy available.~   "
51434|NCT02383914|"~     The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as~     the circumstances require to found a new classification.~      The prime objective is a comparison of the conclusive of the clinic check-up, the~     sonographic and magnetic resonance tomography findings.~      The secondary objective is to detect the correlation of the outcome with the age , the~     gender, the pathogenesis and attendant injuries.~   "
51435|NCT02383901|"~     The purpose of this study is to investigate to which extend osteosarcoma patients do NOT~     meet the criteria for successfully advancement to next planned chemotherapy course.~   "
51436|NCT02383888|"~     To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy~     Chinese and Japanese male subjects following the administration of single rising oral doses~     and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809~     after single dosing of product.~   "
51437|NCT02383875|"~     The Opticourses project aims to improve the nutritional quality/price (NQP) ratio of the~     food purchases of people claiming to be facing financial problems. Following one of the main~     principles of the French National Nutrition and Health Program (PNNS), the project starts~     from the principle that to modify food consumption favourably and durably, one must act on~     both the demand and the supply (see figure). The demand part of the project is based on~     participatory workshops, and the supply part relies on intervention of social marketing in~     shops.~   "
51438|NCT02383862|"~     The purpose of this study is to determine the effectiveness of providing PROMIS Profile~     Scale scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on~     patients' symptoms.~   "
51439|NCT02383849|"~     P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are~     receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis,~     tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment~     containing lopinavir/ritonavir (LPV/r). The study is designed to describe the~     pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the~     drug(s) as part of clinical care.~   "
87746|NCT01908816|"~     The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare~     VEGF driven ocular diseases.~   "
51441|NCT02383823|"~     The study examines the effect of hormone replacement in postmenopausal women compared to~     men, 55 years of age, and in the elderly without hormone replacement of both sexes. The~     lipid and glucose metabolism is evaluated during treatment and placebo with a meal with~     mashed potatoes and different types of fat. Glucose, insulin, triglyceride, total~     cholesterol, LDL and HDL cholesterol, free fatty acids and coagulation parameters are~     measured.~      During menopause the women reduce their levels of estrogen and their risk of cardiovascular~     disease rises to the men's level. This effect on mortality and morbidity can probably be~     reduced by hormone therapy.~   "
51442|NCT02383810|"~     This is a randomized, stratified, double-blind, double-dummy, parallel group,~     placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with~     colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI).~     Patients will receive, starting from the day of chemotherapy administration, a single daily~     dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days.~     Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment~     period for each patient will be 4 consecutive days at each of the first 2 chemotherapy~     cycles.~      The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.)~     placebo and vs. each other dose in the prevention of CID in colorectal cancer patients~     treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal~     antibody.~   "
51443|NCT02383797|"~     The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to~     varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will~     be selected on the basis of disease severity and the degree of immunodeficiency (including~     CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be~     discussed with the patients/caregivers beforehand and acyclovir will be used to treat any~     VZV related symptoms, consistent with the current practices. The investigators will verify~     the development of immune response to vaccination by testing for VZV antibodies and~     cell-mediated immunity.~   "
51444|NCT02383784|"~     Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on~     inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged~     42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI~     (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30~     consecutive days. The other meals were consumed under free living condition and subjects~     were instructed to select foods presenting GI values corresponding to the allocated group.~     Body composition (body mass index, body fat percentage, waist circumference and waist-hip~     ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha,~     high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and~     metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids,~     triglycerides and fructosamine) were assessed at baseline and after intervention. Food~     intake was monitored during the study. The criterion for statistical significance was~     P<0.05.~   "
51445|NCT02383771|"~     The purpose of this study is to determine the proportion of untreated donor platelets~     required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in~     healthy persons and patients with coronary artery disease undergoing percutaneous coronary~     intervention (PCI) and receiving ticagrelor.~   "
51446|NCT02383758|"~     The purpose of this study is to try to treat bowel movement (BM) accidents differently with~     children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC)~     medications to evoke predictable bowel movements. This will make it possible for~     investigators to use certain strategies to reward BMs in the toilet. Independence will be~     increased by fading out the use of medications. The investigators will also train caregivers~     to implement the procedures.~   "
51447|NCT02383745|"~     In Kuopio University Department of Clinical Neurophysiology there have been designed a fast~     EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high~     quality EEG and can detect the most important EEG abnormalities comparable to conventional~     EEG. This study will address the clinical use of acute EEG with fast electrode set in~     in-hospital patients who have been consulted by Medical Emergency Team because of seizure or~     altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG~     monitoring will continue for 24 hours.~   "
51448|NCT02383732|"~     The purpose of this study is to demonstrate the feasibility of the Elopement Prevention~     Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in~     eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come~     up with a safety plan to prevent their children from running away or wandering off.~   "
51449|NCT02383719|"~     Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive~     ventilation (non-intubated) with a feasibility study.~   "
51450|NCT02383706|"~     Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and~     current screening tools for OSA have not been shown to be reliable in pregnant women. The~     primary aim of this study is to develop a valid screening tool to identify at-risk pregnant~     women, so that they can be further evaluated and treated. Women with OSA may also be at risk~     for respiratory complications related to opiate administration for post-cesarean delivery~     pain. A secondary aim of this study is to evaluate post-operative minute ventilation in~     women who undergo cesarean delivery using a novel method of non-invasive minute ventilation~     monitoring.~   "
51451|NCT02383693|"~     number of center : 1~        -  duration of study : 24 months~        -  recruitement time : 23 months~        -  Aim :Principal~      Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled~     study for TRD patients.~      Secondary~      Evaluate the impact of rTMS on cognitive functions.~   "
51452|NCT02383680|"~     Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking~     travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva,~     Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to~     the Swiss Federal Office of Public Health's vaccination recommendations are invited to~     participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF~     antibody production in patients taking low-dose MTX and HC will be compared after YF~     vaccination. It will be analyzed whether the percentage of people with protective antibodies~     differs between the two groups and (iii) vaccine side effects will be compared between the~     groups.~   "
51453|NCT02383667|"~     The objective of the study is to compare electrocardiograms using ambulatory holter monitor~     with dry electrodes in a harness versus using an ambulatory holter with standard sticky~     electrodes (Red Dot) on monitored patients within the hospital. Patients will be~     simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be~     not less than one hour. One holter will use standard electrodes in a standard electrode~     distribution. The second holter will use dry electrodes in a derived.~   "
51454|NCT02383654|"~     The purpose of the study is to determine the safety and possible effectiveness of Autologous~     Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.~   "
51455|NCT02383641|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman~     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
51456|NCT02383628|"~     The main objective of the study is to evaluate the efficacy of indocyanine green (ICG)~     endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes~     patients with pituitary and intracranial tumors and treatment of vascular abnormalities such~     as aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the~     additional visual information supplied during the treatment of these pathologies.~   "
51457|NCT02383615|"~     Saphenous nerve blocks can be technically challenging. Recently described ultrasound~     techniques have improved the success rate of saphenous nerve blocks, but randomized~     controlled trials comparing these techniques are lacking. The investigators compared two~     common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the~     adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.~   "
51458|NCT02383602|"~     HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants~     Same-day result HIV testing along with pre-test and post-test counseling, including risk~     reduction counseling, will be provided according to the standard practice at each study site~     at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can~     also access non-occupational post-exposure prophylaxis service and symptomatic STD service~     if these are available at study sites. HIV-positive participants will also receive risk~     reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.~   "
51459|NCT02383589|"~     This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm~     multicenter study to evaluate the efficacy and safety of rituximab compared with~     mycophenolate mofetil (MMF) in patients with moderate-to-severely active pemphigus vulgaris~     (PV) requiring 60-120 mg/day oral prednisone (or equivalent). Patients must have a confirmed~     diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and~     immunohistochemistry) and evidence of active disease at screening.~      Approximately 124 patients will be enrolled at up to 60 centers worldwide. Patients will be~     randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo~     plus MMF. Randomization will be stratified by duration of illness.~      The study will consist of three periods: a screening period of up to 28 days, a 52-week~     double-blind treatment period, and a 48-week safety follow up period that begins at the time~     of study treatment completion or discontinuation.~   "
51460|NCT02383576|"~     This study aims to understand better the effective results from the IMELDA MO22223 P-trial~     (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after~     study treatments were terminated possibly had an effect on efficacy results.~   "
51461|NCT02383563|"~     This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques~     and calcified plaques assessed by coronary CT angiography, and on whether these changes can~     be explained by metformin-induced phenotypic and secretory changes of monocytes.~   "
51462|NCT02383550|"~     This study is designed to demonstrate that Tysabri is effective in maintaining cognition in~     MS patients after 5 or more years of continuous treatment.~      During a second period of 36 months, the extension study will assess the evolution of~     cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test~     (SDMT) and a CogState battery of tests.~   "
51463|NCT02383537|"~     The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance~     on the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical~     cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman~     over going a C-section. Healthy pregnant women will serve as a control group.~   "
51464|NCT02383524|"~     The Investigators have designed this exploratory study in patients suffering from~     zygapophysial joint mediated pain to investigate if a correlation exists between~     inter-individual genetic variability (genotype) with treatment response (phenotype). More~     specifically, the investigators aim to identify any form of correlation between a specific~     SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency~     facet joint neurotomy. The study population is patients suffering from chronic low back pain~     who have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint~     mediated pain (using medial branch block test). The investigators will evaluate if a common~     variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain~     relief following RF treatment, and whether the result of such a procedure can be predicted~     from a specific genetic profile.~   "
51465|NCT02383511|"~     Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is~     to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with~     Duchenne Muscular Dystrophy (DMD) who follow a balanced diet.~   "
51466|NCT02383498|"~     TRIAL SUMMARY~      Researchers at the National Cancer Institute (NCI) are now enrolling patients in a phase 2~     clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the~     effectiveness of radiation for patients with localized chordoma. Chordoma patients with~     inoperable or residual tumor who do not have metastases and are planning to be treated with~     definitive (>70Gy) radiation are eligible to participate. Patients will initially be~     randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. Those~     randomized to receive radiation plus placebo will have the option to receive vaccine if~     their tumor grows while on the study. The study will compare the outcomes of patients~     treated with radiation with and without the vaccine to determine whether the vaccine can~     increase the chances of shrinking the tumor and/or preventing further tumor growth.~      WHY THIS TRIAL IS BEING DONE~      The primary treatment options for chordoma currently consist of surgery and high dose~     radiation. Radiation has been shown to improve patient outcomes following surgery. Radiation~     is also sometimes used instead of surgery when surgery would carry unacceptable risks.~      The chance of tumor growth after radiation is significantly higher for patients who have~     residual tumor than for those whose tumor is completely removed. Unfortunately for patients~     with a tumor that cannot be completely removed, there tends to be a short time until the~     tumor grows back and eventually causes death. For this reason, our team at the NCI seeks to~     identify a therapy that can reduce the risk of recurrence and improve survival after~     radiation for patients who have residual tumor.~      One approach we are pursuing is treating patients with a therapeutic vaccine that is~     intended to stimulate the immune system to fight cancer cells that express the brachyury~     protein. Brachyury is present at very high levels in nearly all chordomas but is not present~     in the vast majority of normal tissues, making it a promising target for immune therapy.~     Research in other cancers suggests that radiation in combination with immune therapy can~     provide powerful antitumor effects.~      We have recently completed a phase 1 clinical trial of a therapeutic vaccine targeting~     brachyury called GI-6301 in which 11 chordoma patients participated. Through that phase I~     trial, we learned that this vaccine can be given safely without serious adverse reactions.~     In that study, the vaccine was also capable of inducing immune responses against brachyury~     and one patient had his tumor shrink more than 30% while on study. Some other patients (7 of~     10 evaluable) also had stable disease for more than 5 months while on study. However, these~     clinical findings are not definitive and further clinical testing is required to determine~     the benefit of this vaccine in chordoma. To that end, we have designed a larger phase 2~     clinical trial intended to determine if this vaccine, when given in combination with~     radiation, improves outcomes for patients with chordoma compared to those who only have~     radiation.~      WHO CAN PARTICIPATE~      We have designed this trial for patients who have residual tumor remaining after surgery,~     who are unable to have surgery, or who have a local recurrence following previous treatment.~      To be eligible for enrollment on this study, patients must:~        -  Have a confirmed diagnosis of chordoma~        -  Have only localized tumor (no metastases)~        -  Be able to receive at least 70 Gy of radiation to their localized tumor~        -  Be willing to travel to Bethesda, MD for treatment and follow-up visits~      HOW THE TRIAL WILL WORK~      The trial is taking place at the National Institutes of Health Clinical Center in Bethesda,~     MD. The NCI will pay for transportation costs (including airfare) and a portion of lodging~     costs for patients after enrollment in this study.~      The process of participating in the trial is as follows:~        -  Patients travel to NIH to receive injections of the vaccine (or placebo) every other~          week for three doses prior to starting radiation (approximately 4 weeks)~        -  Patients then complete their radiation treatment with their home radiation oncologist~          (typically over a 1-2 month timespan)~        -  Following completion of radiation treatment plan, patients travel back to NIH to resume~          vaccine (or placebo) injections every 2 weeks until 6 total doses have been given (3~          doses after radiation, another 4 weeks)~        -  At that point, doses spread out to every 4 weeks for 4 doses, and then 1 dose every 3~          months until disease progression.~        -  Between all doses of vaccine, patients may return home and travel back for the next~          visit. There is no requirement to stay locally in Bethesda at any point in the study~          outside of clinic visits and dosing days.~        -  Repeat imaging studies will be performed about 3 months after completion of radiatio...~   "
51467|NCT02383485|"~     Nonalcoholic fatty liver disease is a serious health condition in overweight children which~     can lead to heart disease. This project will examine the links between liver health and~     cardiovascular risk factors in overweight and obese children, and will test the effect of a~     long-term after-school exercise program.~      Provision of comprehensive evidence for the benefits of exercise on children's health may~     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.~   "
51587|NCT02381912|"~     The purpose of the study is to investigate sexual function in patients suspected of non~     muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual~     function is underdiagnosed in patients with non-muscle invasive bladder cancer and that~     active examination and treatment may worsen the sexual function.~   "
51468|NCT02383472|"~     A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering~     from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with~     cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo~     therapy (controls) or treatment with LED therapy (cases). Both cases and controls would~     complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and~     ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms~     resolve before the end of the 6 week period.~   "
51469|NCT02383459|"~     Food habits form early in infancy and are likely to track into childhood until the beginning~     of adulthood. Understanding the factors driving the acceptance of foods in the early years~     is therefore of particular importance, since these foods will form the basis of a child's~     future food repertoire. This is especially important for vegetables, which consumption is~     recommended at all stages of life but is below the recommended levels and which acceptance~     is difficult to promote during late childhood.~      The objective of the present study was to unravel the respective contribution of maternal~     feeding practices, of children's rate of exposure to vegetables and of children's sensory~     reactivity factors over the course of the first two years, to explain the development of~     liking for vegetables at the age of 2 years. This analysis took advantage of data recorded~     in a prospective cohort of children recruited before birth and followed up longitudinally~     until the age of 2 years.~   "
51470|NCT02383446|"~     Background:~      Trauma is the second most common factor for transtibial amputations, just after vascular~     background. Traumatic amputees generally function better than amputees due to vascular~     background. The type of prosthetic foot fitted to the patient depends on his mobility and~     functional level, and significantly influences his stability and gait symmetry. A prosthetic~     foot with a hydraulic ankle provides significant advantages for high level functioning~     amputees: decrease of loads in the residuum, improvement in symmetry and generally gait~     pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded~     to include computerized control over the ankle movement, using input from an array of~     sensors inside the foot. Studies have demonstrated decrease in energy consumption and gait~     pattern that is more similar to healthy people. However, hydraulic feet with and without~     computer control have not been compared. Furthermore, the effects of a computerized foot on~     various important factors have not been investigated yet, e.g. loads in the residuum, the~     movement of the center of pressure and the patient's satisfaction.~      Research objectives:~      To compare between hydraulic prosthetic feet, with and without computerized control. The~     comparison will be made while walking on flat or inclined surfaces (positive or negative~     inclination). Differences in gait parameters, loads inside the residuum, center of mass~     movement and patient's satisfaction will be quantified.~      Research hypothesis: Using a computerized prosthetic foot will provide better mobility~     performances: improved gait factors and center of pressure movement, decrease internal loads~     in the residuum and increase patient's satisfaction.~      Research design:~      Clinical controlled research with research group(amputees) and control group (healthy).~   "
51471|NCT02383433|"~     This phase II trial studies how well regorafenib and gemcitabine hydrochloride work as~     second-line therapy (treatment given when initial treatment doesn't work) in treating~     patients with pancreatic cancer that has spread to other parts of the body. Regorafenib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving regorafenib together with gemcitabine hydrochloride may~     kill more tumor cells.~   "
51472|NCT02383420|"~     The purpose of this clinical study is to evaluate the imaging performance of the Carestream~     PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the investigational~     devices) as compared to the currently marketed Carestream DRX-1 Detector (referred to as~     the predicate device). Both detectors are flat panel digital imaging devices. The results~     of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to~     market the new detectors in the US. The study was designed in accordance with the FDA~     Guidance titled Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging~     Devices, issued on August 6, 1999.~   "
51473|NCT02383407|"~     The primary aim of the current proposal is to evaluate safety and tolerability, in terms of~     neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in~     participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims~     include evaluation of psychiatric changes, seizure frequency, and quality of life during~     LFSF.~   "
51474|NCT02383394|"~     Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy~     loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.~   "
51475|NCT02383381|"~     •Background and study aims : The investigators conducted this study to evaluate the movement~     of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.~        -  Who can participate? patients who underwent typical lateral rectus recession surgery~          for correcting intermittent exotropia~        -  What does the study involve? Volunteers will attend a clinic for four visits over six~          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is~          non-invasive test to evaluate operation site. The test only requires their cooperation~          when they undergo AS-OCT.~        -  What are the possible benefits and risks of participating? This is non-invasive test~          for your postoperative follow up. Therefore, there will be no risks about this test.~        -  Where is the study run from? Samsung Medical Center~        -  When is the study starting and how long is it expected to run for? From Feb 2014 to Dec~          2014~   "
51476|NCT02383368|"~     The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to~     determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will~     also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor~     activity.~   "
51507|NCT02383030|"~     Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of~     all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some~     patients will present metastatic recurrence.~      Treatment of breast cancer is determined by the extent of the disease. Early or localized~     breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic~     therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone~     responsive, can prolong the disease-free interval and improve overall survival. However,~     approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with~     either local recurrence or distant metastases, and require further systemic treatment for~     advanced disease.~      Since breast cancer that recurs or progresses after initial treatment is considered~     incurable, the therapy options available for advanced disease are concerned with disease~     control and palliation of symptoms.~      Hormonal therapy has become the treatment of choice in postmenopausal women with hormone~     sensitive breast cancer. Even though the treatment of advanced breast cancer in~     postmenopausal women has improved with the introduction of agents such as aromatase~     inhibitors, these agents still have limitations, and disease management continues to be~     sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new~     biological treatment is to reduce tumour masses, improve survival and preserve quality of~     life. Whatever the initial efficacy of the treatment undertaken in metastatic setting,~     almost every patient will relapse. The main goal is to improve progression free survival~     (PFS). To achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the~     benefit of maintenance chemotherapy, the benefit of maintenance hormonal treatment are~     debatable.~   "
51477|NCT02383355|"~     Cardiovascular disease (CVD) has emerged as a leading cause of morbidity and mortality in~     HIVinfected individuals. The precise mechanisms underlying this increased cardiovascular~     risk remain to be elucidated. Platelet hyperreactivity and increased platelet-monocyte~     aggregation (PMA) are found in HIVinfectedpatients and may contribute to the excess~     cardiovascular risk as platelets play a key role in the onset and progression of~     atherosclerosis and in acute cardiovascular events. In addition, HIV-infected individuals~     frequently suffer from persistent immune activation and inflammation. In a crosssectional~     study the investigators recently showed that individuals using a regimen containing the~     integrase inhibitor raltegravir have reduced platelet hyperreactivity and PMA compared to~     other antiretroviral regimens. Other recent studies showed that raltegravir is associated~     with decreased immune activation. Due to the inherent limitations of cross sectional~     studies, the investigators aim to expand our findings in an intervention study. The~     investigators will conduct a randomized control trial where the investigators switch~     patients to a integrase containing treatment regimen to assay possible changes in platelet~     function and persistent immune activation. Knowledge gathered in the proposed study can help~     understand and prevent cardiovascular disease in patients treated for a HIV infection by~     reducing platelet hyperreactivity and persistent immune activation.~   "
51478|NCT02383342|"~     Pain is the most frequent cause of suffering and disability in society. Despite considerable~     involvement of genetic factors in pain sensation and sensitivity, the individual genes~     involved remain largely unidentified.~      Knowledge of genetic factors,their phenotypic expression in pain processing, and their link~     to neuronal correlates can improve our understanding of pain aetiology and the processes~     involved in pain perception and chronification. In addition, they can serve as biomarkers to~     predict chronic pain development and progression in individual patients and help early~     individual treatment adaptation.~   "
51479|NCT02383329|"~     The purpose of this study is to test whether the provision of ONS to malnourished children~     across Europe, in addition to standard counselling, will improve weight gain and other~     outcomes.~      The hypothesis to be tested is:~      • Supplementation with ONS in malnourished paediatric patients will lead to increased WFH~     gain, as well as less malnutrition related complications (e.g. infections).~      Primary outcome • The change in BMI z-score over the intervention period of 3 months~      Secondary outcomes~      • The change in WFH-weight for height (z-scores) over the intervention period of 3 months~   "
51480|NCT02383316|"~     Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized~     by the association of craniofacial manifestations, cardiopathies, short stature, and tumor~     predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the~     Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine~     phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy~     metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that~     are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose~     tolerance) have been recently identified in an original mouse model carrying Shp2 mutation.~     Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected~     from developping overweight and obesity when compared to the general population. However,~     the metabolic status associated with Noonan Syndrome condition has not been explored to~     date.~   "
51481|NCT02383303|"~     The U.S. Department of Health and Human Services, Administration for Children and Families~     (ACF) is conducting an experimental evaluation of the Assets for Independence (AFI) Program.~     This evaluation—the first experimental evaluation of Individual Development Account (IDA)~     projects operating under the Assets for Independence Act—will contribute importantly to~     understanding the effects of IDA projects and IDA project features on participants. IDA~     programs provide matching funds to participants when the savings are withdrawn to spend on~     qualified asset purchases, most commonly homeownership, business-related expenses, or~     education.~      This study will build on the prior quasi-experimental AFI evaluation, as well as studies of~     other non-AFI funded Individual Development Account (IDA) projects. While some evaluations~     suggest that IDAs help low-income families save, rigorous experimental research is limited.~     No experimental evaluation of AFI-funded programs has been conducted to date. Of the quasi-~     or non-experimental studies, few have focused on AFI-funded IDAs.~      The evaluation is being conducted in two sites, with the random assignment of 299~     AFI-eligible cases in one site and 509 cases in the other, for a total of 808 cases. Each~     site randomly assigned sample members to one of two groups: a control group and a treatment~     group receiving conventional AFI services. The primary research questions the study seeks to~     answer are:~        1. What are the impacts of AFI program participation on the outcomes it is designed to~          address (e.g., savings and asset purchases)?~        2. What are the impacts of AFI program participation on other outcome domains that the~          program might influence (e.g., material hardship, alternative financial product use,~          economic well-being)?~        3. How do the impacts of AFI program participation vary over time and by participant~          characteristics?~      The study uses a two-armed (treatment vs. control) experimental design. This design allows~     the first two questions above to be addressed using a rigorous randomized approach.~      In addition to the impact study, the evaluation includes an implementation study to describe~     and document how the AFI program is designed, implemented and operated in the participating~     grantee sites during the time of the study. This information will be used to provide context~     for interpreting the findings of the impact study.~   "
51482|NCT02383290|"~     Certain parts of the gene can predict how an individual person will respond to medication~     (pharmacogenetics). We will invite 250 individuals to give a sample of saliva. This sample~     will be sent to a laboratory for limited genomic analysis relating to pharmacogenetics. When~     personal data held by the participants, family physician, or pharmacist is joined with the~     genetic data personalized prescription recommendations are formed. The family~     physicians/pharmacists can view these recommendations through their electronic record. This~     should result in prescriptions that may be more beneficial and cause fewer adverse events.~   "
51483|NCT02383277|"~     Investigate the effects of stretching the muscles of the rib cage in individuals with COPD~     during exercise.~   "
51508|NCT02383017|"~     This study will examine how the supplement Shroom Tech Sport (STS) affects body composition~     and different performance and health measures over the course of 12 weeks. The supplement~     will be combined with a concurrent training regime consisting of resistance and high~     intensity interval training. Subjects will be tested for percent body fat to determine body~     composition. Further, they will also be tested for maximal strength (squat and bench),~     maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption~     (VO2max). And finally, subjects will be tested for health and hormone markers in the blood.~     All of these measures will be compared against a placebo group participating in the same~     exercise intervention.~   "
51539|NCT02382614|"~     VAST is a multicenter, prospective, randomized, controlled study designed to evaluate~     treatment of persistent air leak with the SVS as compared to standard chest tube drainage~     management and other standard-of-care interventions in the control group. Eligible subjects~     will be randomized to receive either Spiration Valves (investigational arm) or continue~     standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves~     should be removed.~   "
51484|NCT02383264|"~     Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a~     challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm~     infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis~     (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence~     of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the~     establishment of an adequate early enteral nutrition is frequently hampered. Early~     identification of preterm infants at high risk for gastrointestinal complications could help~     clinical decisions on the introduction and the advancement of enteral feeding.~      Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen~     saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the~     first week of life and subsequent NEC development has been reported. To date, however,~     splanchnic oxygenation patterns in response to the first bolus feed and possible~     correlations with subsequent FI development have not been yet established.~      This observational prospective study aims:~        -  to assess abdominal rSO2 patterns in response to the first bolus feed;~        -  to evaluate possible correlations with subsequent development of gastrointestinal~          complications.~   "
51485|NCT02383251|"~     Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory~     ovarian cancer who relapse during bevacizumab maintenance.~   "
51486|NCT02383238|"~     Dapagliflozin leads to improved vascular function in the micro- and macrocirculation by~     action on various cardiovascular risk factors, in particular by effectively controlling~     hyperglycemia, arterial hypertension and reducing whole sodium content amongst others.~   "
51487|NCT02383225|"~     This study involves adaptation, implementation, and rigorous evaluation of a family-based~     program designed to prevent early initiation of substance use on a Northern Plains Indian~     reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa~     Strengthening Families Program for Parents and Youth 10-14. Youth and their~     parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre-~     and post-intervention surveys assessing a variety of risk and protective factors and youth~     outcomes. The evaluation design will allow the assessment of the effectiveness of different~     components within the program.~   "
51488|NCT02383212|"~     This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810,~     alone and in combination with other anti-cancer therapies in patients with advanced~     malignancies.~   "
51489|NCT02383199|"~     The purpose of this study was to report the long-term objective and subjective outcome after~     prolapse surgery with polypropylene mesh. The complications and the effect of the learning~     curve of the surgeons to the outcome is also reported.~   "
51490|NCT02383186|"~     The purpose of this study is to determine whether a single layer dermally sutured wound~     results in superior outcomes to a layered closure.~   "
51491|NCT02383173|"~     The overarching goal of this research program is to improve the quality of end-of-life care~     provided to Veterans dying in VA Medical Centers, by transferring the best practices of home~     hospice and palliative care for the last days and hours of life into the inpatient setting.~     This trial will examine two methods of delivering a Comfort Care Education Intervention~     utilizing the established infrastructure of VA Palliative Care Consult Teams (PCCT): a Basic~     Implementation Approach using a teleconference to review educational materials and activate~     PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing~     in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers~     at their home sites. Findings will provide a robust evaluation of the implementation~     process, and will be used to refine the Comfort Care Education Intervention and~     implementation strategies in preparation for nationwide dissemination of best practices for~     end-of-life care within the VA Healthcare System.~   "
51492|NCT02383160|"~     This is a prospective, double-blind, randomized controlled trial to determine the~     effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid~     non-unions after operative fixation as measured by serial CT scanning. Multiple centers~     within the Calgary zone will be involved in the study in order to recruit enough patients to~     power the study. Blinding will include patients, surgeons, research assistants, as well as~     all data handlers and analysts until trial completion or mid-term analysis.~   "
51493|NCT02383147|"~     Chronic tinnitus affects about 10-15% of the population in industrialized countries.~     Investigations of the brain activity by using electroencephalography (EEG) showed that in~     localized regions of the hearing system brain activity was decreased. This reduction of~     activity is thought to be one of the reasons that keep the perception of the tinnitus going.~     Recent studies have shown that neurofeedback is a viable option for treatment of chronic~     tinnitus. By using neurofeedback it is possible to train brain functions by the simple~     principle of rewarding wanted changes and punishing unwanted ones. The purpose of the~     investigators study is to show the efficacy of specific localized neurofeedback training in~     comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus~     symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned.~     Before and up to 6 month after the training EEG-recordings are performed.~   "
51494|NCT02383134|"~     The achievement of peripheral nerve block requires several needle passes, with each of them~     being at risk of causing nerve injury either by direct trauma or intraneural injection even~     with the use of the ultrasound.~      The ultrasound guided supraclavicular brachial plexus block is known to be at risk of~     pneumothorax and / or nerve injury.~      This study is designed to determine the maximal effective distance away from the nerve for~     the injection to be effective.~   "
51495|NCT02383121|"~     Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading~     cause of long-term disability. Early neurological deterioration after AIS typically occurs~     within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher~     rate of death or poor outcome. Several mechanisms account for early neurological~     deterioration, including hemorrhagic conversion, systemic illness, cerebral edema, and~     seizure, but the most common cause is extension of the stroke into the penumbra, a region~     of salvageable brain tissue surrounding the core of irreversible ischemic infarct. The~     penumbra is tenuously perfused by collateral blood vessels. AIS management is primarily~     focused on recanalizing the occluded artery causing the stroke, but an alternative and~     relatively unexplored approach is optimization of collateral blood flow.~      Over 60% of AIS patients present with a transient acute hypertensive response, which is~     theorized to be the result of either increased sympathoadrenal tone, poorly controlled~     underlying hypertension, or an unknown stroke-specific mechanism related to augmenting~     cerebral perfusion through collateral blood flow. Epidemiological data suggests worse stroke~     outcomes are associated with extremes of sustained hypo- or hypertension, which has led to~     dozens of clinical trials involving over 20,000 patients to determine if pharmacologically~     lowering blood pressure after AIS is beneficial. The results have been persistently neutral~     or negative. In contrast, there have been no major clinical trials on the efficacy of using~     vasopressor medications to maintain or increase baseline blood pressure after AIS, despite~     promising preclinical data and pilot studies that showed no increase in cerebral hemorrhage~     or edema. The only randomized trial of vasopressor use after AIS demonstrated an improvement~     in clinical outcomes, but there was no difference in mean blood pressure between the control~     and intervention arms, suggesting the beneficial effect was not exclusively related to~     induced hypertension. One possibility is that the vasopressor reduced blood pressure~     variability, which preliminary data has shown to be detrimental after AIS, although that~     aspect of neurovascular coupling has not been adequately studied in the acute phase after~     AIS.~      The reliance on IV vasopressors, which are only administered in the intensive care unit, is~     a fundamental limitation of prior research. An alternative, but untested, approach is to use~     the oral vasopressor midodrine hydrochloride. We hypothesize that frequent midodrine dosing~     after AIS can optimize collateral blood flow and help salvage the ischemic penumbra. The~     objective of this study is to develop tools to quantify midodrine's effect on blood pressure~     and the ischemic penumbra. To achieve this objective within the period of early neurologic~     deterioration, we propose a 72-hour protocol of fixed-dose midodrine administration in 20~     AIS patients, with detailed hemodynamic and cerebral perfusion measurements recorded before~     and during the treatment period.~   "
51496|NCT02383108|"~     A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and~     antiviral effect of current standard antiretroviral therapy compared to elvitegravir (EVG)~     administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed~     paediatric participants.~   "
51497|NCT02383095|"~     The main purpose of the protocol is to test the efficiency of art-therapy versus~     metacognitive rehabilitation on the visual perception disorders observed in patients with~     schizophrenia.~   "
51564|NCT02382289|"~     Expecting using bipolar RF at six points, in spite of potentially consuming more~     intraoperative time, to be more effective and long lasting in the management of pain~     resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the~     monopolar RF even if using six points.~   "
51498|NCT02382042|"~     Background Participation in continuing care is one of the two most significant factors in~     preventing relapse after intensive Substance Use Disorder (SUD) treatment.1 A primary~     component of continuing care, social support, is a protective factor for SUD treatment~     relapse.2 Social support provided by community self-help groups (e.g. 12-step programs such~     as Alcoholics Anonymous) improves Substance Use Disorder (SUD) treatment outcomes.1,4~     Post-treatment referral to self-help groups was recently described as an effective,~     low-cost option,3 but counselors vary in their referral methods, often simply telling~     patients to find and attend meetings in their community.~      In a study of urban veterans leaving treatment, researchers increased 1-year SUD abstinence~     rates by more than 24% through a three-step intensive referral intervention.5 First,~     counselors discussed the importance of social support and meeting attendance. Second,~     counselors identified accessible self-help meetings near the SUD treatment site and arranged~     for a meeting liaison to accompany the patient to a meeting. Third, counselors followed up~     on attendance and addressed obstacles. A follow-up study found patients with co-morbid SUD~     and psychiatric problems significantly benefitted from the intervention.6~      The investigators have adapted this intervention so that it can be utilized in a rural as~     well as urban setting. The investigators have trained clinical staff, measured their~     fidelity to the intervention and successfully implemented it across three Veteran's Affairs~     (VA) Substance Use Disorder (SUD) treatment programs (Omaha, Lincoln and Grand Island). In~     2012 an intriguing study showed that peer referral to 12-step support groups was~     significantly more effective than clinician referral.7 This is of particular interest given~     the scarcity of addiction counselors in rural communities and enhances the intervention's~     applicability to rural settings and other disciplines.~      Specific Aim The investigators propose implementing this intervention in a correction~     population (Intervention Group) and comparing outcomes between the Intervention Group and a~     group who are receiving standard correction services (Standard Group).~      Methods Phase I: Adapt Intensive Referral Intervention for correction population Phase II:~     Train correction staff in Intervention Research staff will train and continue to monitor~     trained correction staff to ensure fidelity to intervention and provide feedback to staff~     and leadership regularly.~      Phase III: Comparison between Intervention Group and Standard Group The two groups will be~     compared on measures of interest to the Nebraska Department of Correctional Services and on~     measures of substance use, support group attendance and involvement at standard time points.~   "
51499|NCT02382029|"~     Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning~     symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy~     might be the underlying cause of the condition. There are still insufficient data regarding~     successful therapy. The aim of this study was to compare efficacy of acupuncture and~     clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years.~      Methods: Patients were randomly divided into two groups. Acupuncture was performed in group~     I during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on~     both sides of the body as well as GV 20, each session lasted half an hour.Group II patients~     took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5~     mg) in the morning and in the evening during the next two weeks. Prior to and one month~     after either therapy, participants fulfilled questionnaires: visual analogue scale, Beck~     depression inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and~     Montreal Cognitive Assessment (MoCA). Statistical analysis was performed by use of Student t~     test and Pearson's correlation test. P values lower than 0.05 were considered significant.~   "
51500|NCT02382016|"~     24-week study to evaluate the efficacy and safety of macitentan for the treatment of~     portopulmonary hypertension.~   "
51501|NCT02382003|"~     The study aims to develop a web-based Cognitive Bias Modification infrastructure to train~     interpretations, and evaluate the usability, acceptability, and feasibility of the program~     to reduce anxiety symptoms.~   "
51502|NCT02381990|"~     Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by~     Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome~     measure is 5 year oncological control. Secondary aim is lack of progression beyond the~     prostate gland. The aim of intervention is to eradicate prostate cancer disease in the~     treated area while imposing no or minimal deleterious effects in quality of life.~   "
51503|NCT02381977|"~     PANGEA is an international prospective point prevalence study to describe the epidemiology,~     interventions, and outcomes in children with acute critical brain disease.~   "
51504|NCT02383069|"~     Asthma is one of the main chronic diseases in childhood and it is characterized by the~     inflammation of airways. Individuals with chronic lung disease are more susceptible to~     present reduction in exercise tolerance due to pulmonary limitations. The pulmonary~     rehabilitation may improve the physical capacity in asthmatic patients, as observed in other~     chronic lung diseases.~   "
51505|NCT02383056|"~     The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in~     promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg~     heal more slowly than wounds on the head and neck; they can also remain deep red for six~     months to one year. Doctors usually allow a lower leg surgical wound to heal by itself,~     without stitches or other additional treatment. This is because leg wounds do not hold~     stitches well and stitches could cause other problems. A major drawback of allowing a~     surgical wound on the lower leg to heal by itself is the long healing time that can often~     take months. The investigators wish to evaluate if the LED light treatment of the surgical~     wound will improve the healing of your wound.~      In order to test if leg wounds heal faster after treatment with LED, half of the patients in~     the study will receive the LED (Group 2) and half will not receive treatment with LED but~     will receive a sham light treatment (Group 1). Essentially, a sham light treatment refers~     to regular light (not LED) exposure for 20 minutes. The sham light comes from the same~     device as the treatment light (Omnilux machine) however, this light has no anticipated~     effects on wound healing and is used simply to reduce the amount of bias that sometimes~     complicates the results of these studies. There is no added risk or benefit for the patients~     in the control group exposed to the sham light. Both groups will receive the standard care~     of wounds on the lower extremity.~   "
51506|NCT02383043|"~     Cocaine-use disorders continue to be a significant public health concern, yet no effective~     medications have been identified. The goal of this study is to establish a research platform~     for the development of medications for treatment of cocaine abuse and dependence. This study~     will incorporate choice self-administration procedures between drug and a non-drug~     alternative reinforcer presented during maintenance on d-amphetamine, which has been~     previously shown to reduce cocaine use.~   "
51520|NCT02382861|"~     The NAVA, by its more physiological aspect and a better adaptation of the patient to the~     ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration~     of weaning and so decrease the duration of invasive mechanical ventilation and the~     morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory~     assist versus the usual management of weaning from mechanical ventilation, in term of~     duration of weaning, at the patients in period of difficult weaning from the invasive~     mechanical ventilation.~   "
51521|NCT02382848|"~     This research is being done to find out how effective Prazosin is in the treatment of~     bulimic patients experiencing distressing nightmares using subjective and objective~     measures.~   "
51509|NCT02383004|"~     Myringotomy tube placement is one of the most commonly performed operations in children.~     Emergence delirium after such procedures is common. During emergence delirium children can~     become both a danger to themselves and others around them, including family members and~     hospital staff.~      The primary objective of this study is to determine if acupuncture, when used in combination~     with standard anesthetic management, decreases the incidence of emergence delirium in~     pediatric patients following myringotomy tube placement. Patients with and without~     premedication of midazolam will be included. A secondary objective of this study is to~     determine our institution's actual incidence of emergence delirium for this operation using~     a validated scale, the Pediatric Anesthesia Emergence Delirium (PAED) scale. We will also~     compare rates of emergence delirium in patients that received a premedication of midazolam~     versus (V) those that did not (NV).~      This is a randomized double-blinded trial. We will enroll 100 children aged 1-6 years old.~     Premedication with midazolam will be decided by the anesthesiologist. If needed, the patient~     will receive a standard does of oral midazolam plus acetaminophen (V). If the patient does~     not require premedication with midazolam, oral acetaminophen will be given alone (NV).~      Patients will then be randomized to receive either acupuncture with standard general~     anesthesia care (A) or to receive standard anesthetic care alone (S). Patients, their family~     members and recovery registered nurses (RNs) will not know if acupuncture was performed.~     Intraoperative anesthetic techniques will be standardized and include inhaled inductions~     with nitrous oxide and sevoflurane. Anesthesia maintenance will be inhaled sevoflurane and~     the usual pain medication ketorolac will be given intramuscularly prior to emergence.~     Acupuncture needles will be placed after anesthesia induction and removed prior to leaving~     the operating room. A total of 4 needles will be placed, one in each wrist at the Heart 7~     (HT7) point and one in each ear at the Shen Men point. The needles will be inserted~     bilaterally to a depth of 1.8 mm.~      In the PACU, a blinded study observer will evaluate the patient at four time points using~     the PAED scale: time of awakening and 5, 10 & 15 minutes after awakening. Follow up phone~     calls will be made one day and one week after surgery. Families will be asked about behavior~     after discharge, sleep and bed-wetting.~   "
51510|NCT02382991|"~     Moderately active amputees may have lost their limb due to diabetes, vascular conditions,~     trauma, tumour or congenital causes. These amputees currently cannot benefit from having a~     computerised knee because of the performance criteria associated with being given one.~     However, these amputees have a very high risk of falling because they use a non~     microprocessor controlled knee joint (NMPK) and because their physical ability, associated~     disability and persistent contralateral leg weakness do not allow them to compensate for a~     balance deficit. These amputees restrict how much they move around and their participation~     because of their instability and elevated risk of falling.~      The objective of the study is to evaluate the effect of the 3C60 knee, a~     microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the~     risk of falling after three months in moderately active persons with leg amputation above~     knee or knee disarticulation.~   "
51511|NCT02382978|"~     This study will test whether or not nurses can provide well child care in a~     multi-disciplinary primary health care team without physicians also seeing the children at~     pre-scheduled well child care visits.~   "
51512|NCT02382965|"~     It is the purpose of this proposal to apply tFUS to the ventral posterior lateral (VPL)~     nucleus of the thalamus in humans.~   "
51513|NCT02382952|"~     The primary purpose of this study is to evaluate the quality of blunt dissection during~     abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels~     and neurovascular structures while preserving the integrity of these structures.~   "
51514|NCT02382939|"~     This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of~     once weekly dosing of somapacitan (administered with an investigational pen) with daily~     Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in~     previously human growth hormone (hGH) treated adults with growth hormone deficiency.~   "
51515|NCT02382926|"~     In this trial contactless heart rate, electrocardiography and breathing rate measurements~     are elevated during car simulation in cardiac rehabilitation via automotive sensors and~     camera.~   "
51516|NCT02382913|"~     The purpose of this study is to evaluate the persistence of immune response against the~     three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA)~     and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study~     vaccines or Boostrix® during V113_01 study.~      There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw~     after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood~     was withdrawn.~      No vaccine was administered and no safety data was collected in this study.~   "
51517|NCT02382900|"~     In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital~     warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most~     common oncogenic high-risk genotypes and cause approximately 70% of all cervical cancers~     despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and~     penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are~     HPV associated. A large number of studies, including both adult and young females, have~     demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection~     against infection. Immunogenic vaccination results in young men and boys are equally~     satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men.~     The recommended vaccination scheme includes three shots giving the second at two months and~     the third at six months after the initial shot. Recently, it has been shown that the use of~     a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this~     study is to determine that the immunogenicity is non-inferior in boys using a two shot~     scheme compared with young women and girls.~   "
51518|NCT02382887|"~     Patients who present with an unstable cervical spine following an accident need a general~     anesthesia for the necessary surgery.~      Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.~      However, changes in equipment availability and quality may challenge the fiberoptic~     intubation technique.~      The investigators wish to compare the tracheal intubations performed with the Airtraq in~     comparison with the fiberscopic technique.~   "
51519|NCT02382874|"~     Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important~     manifestation of kidney disease.~      FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS).~      Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients~     eventually still require dialysis.~      Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the~     cells that useful in the treatment of glomerulus disease.~      Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be~     done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then~     monthly until a year following injection day.~   "
51522|NCT02382835|"~     This study aims to determine whether subjects who underwent large-diameter metal-on-metal~     hip arthroplasty are more likely to have developed heart failure or other conditions as~     compared to subjects with conventional hip replacements.~      We plan to link the National Joint Registry for England, Wales and Northern Ireland to the~     National Heart Failure Audit and GP records.~   "
51523|NCT02382822|"~     Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy~     remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular,~     pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors~     probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV~     infection rely on cross-study comparisons of HIV-infected persons with published population~     rates and few prospective studies in U.S. cohorts. Using well characterized participants~     from the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500~     HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or~     develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular,~     2) pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two~     cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related~     factors on development of co-morbidity.~   "
51524|NCT02382809|"~     The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine~     mouthwash in the prevention of alveolar osteitis following third molar extraction and to~     evaluate the safety and local tolerability.~   "
51525|NCT02382796|"~     The purpose of this study to permit continued access to dacomitinib for patients who~     participated in other dacomitinib monotherapy treatment protocols in Japan and have the~     potential to derive clinical benefit without unacceptable toxicity from continued~     dacomitinib treatment.~   "
51526|NCT02382783|"~     The purpose of this study is to determine how best to monitor for flares in patients with~     rheumatoid arthritis (RA).~   "
51527|NCT02382770|"~     To evaluate the different indications to Open Abdomen, the different techniques used to~     perform it, it's management, it's definitive closure and mortality rates linked to the~     different variables. Moreover to evaluate the 1 month and 1 year follow up in patients~     underwent to Open Abdomen.~   "
51528|NCT02382757|"~     This study is conducted in Asia. The primary objective of the CDiC programme is to improve~     access to comprehensive diabetes care among the children with diabetes from the economically~     underprivileged section of the population and to establish a registry for this group of~     children with type 1 diabetes in India.~   "
51529|NCT02382744|"~     Patients undergoing foot and ankle surgery have the option of having a nerve block~     administered by their Anesthesiologist. The nerve block numbs the foot and results in less~     post-operative nausea and vomiting, and better pain control. Two different techniques for~     blocking the saphenous nerve to the foot have been described and are both commonly used at~     St. Paul's hospital. The goal of this study is to compare the success rates of these two~     techniques.~   "
51530|NCT02382731|"~     Proven treatments exist that improve quality of life and reduce the risk of repeat heart~     attacks or death amongst persons who have already had one heart attack. These treatments~     include medications and supervised cardiac rehabilitation programs. Unfortunately, research~     shows that many people who have had a heart attack do not stick with these treatments and~     therefore cannot benefit. This quality improvement research program seeks to understand the~     impact of interventions that could be readily implemented at scale by entire health systems~     or organizations wishing to improve adherence to proven treatments. Specifically, the trial~     will test whether providing Ontario-based patients (and their health professionals) with~     repeated educational reminders delivered via post and phone will help improve the use of~     medications or attendance at cardiac rehabilitation. During the project, the types of~     patients who are most responsive will be identified as will the most cost-effective strategy~     for delivering reminders. The trial team are partnering in this project with health system~     decision makers who have an interest in using the results to create standard operating~     procedures that could benefit patients across the province.~   "
51531|NCT02382718|"~     This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous~     immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy~     to subjects allergic to fish.~   "
51532|NCT02382705|"~     Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common~     indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel~     disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.~      While CE has high diagnostic value for small bowel lesions, a significant limitation of this~     technology is the finite battery life which results in incomplete examination of the small~     bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g.~     prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer,~     chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to~     mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is~     not recommended.~      This study aims to determine whether longer battery of the newer generation capsule~     endoscopy system improves study completion rate and diagnostic yield.~   "
51533|NCT02382692|"~     Sinus surgery is a common procedure. A potential complication is injuring the membranes of~     the brain. This can lead to leakage of brain fluid through the nose. We would like to~     estimate the incident rates of that complication. At the end of the operation, a thin gauze~     is inserted into the nose on both sides in addition to the usual tampon. This gauze will be~     analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.~   "
51534|NCT02382679|"~     The purpose of this study is to assess the efficacy of vitamin therapy in concussion when~     compared to placebo with respect to multiple endpoints including symptom severity, cognitive~     performance on computer based neuropsychological testing, post-concussion balance~     assessment, and post-concussion vestibular-oculomotor function.~   "
51535|NCT02382666|"~     The purpose of this study is to assess the safety and tolerability of single increasing~     doses of intravenously administered rolapitant in healthy male and female subjects.~   "
51536|NCT02382653|"~     100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP)~     (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two~     equal groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group,~     comprising of 50 patients each.~      Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about~     the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain).~     frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or~     over 16 min), time required for dose titration, patient satisfaction and adverse effects~     were assessed at 3, 7, 15, and 30 days after starting the treatment.~   "
51540|NCT02382601|"~     The investigation will employ a longitudinal approach in which every fetus diagnosed to be~     SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated~     imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta~     over time. These findings will be correlated with neurological and cardiovascular function~     in the newborn and early childhood. This research initiative should yield diagnostic and~     therapeutic templates that will improve the quality of life of IUGR babies in addition to~     providing important information that will better inform current diagnostic practices.~   "
51541|NCT02382588|"~     The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the~     treatment of herpes zoster keratitis. Half the patients will receive the study drug while~     the other half of the patients will receive the placebo~   "
51542|NCT02382575|"~     The vast majority of children with idiopathic nephrotic syndrome respond well to~     corticosteroid treatment. However, as many as 20% experience a more complicated course with~     steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children~     often result in long-term complications. The goal of treatment is to reduce the rate of~     relapses, the cumulative dose of corticosteroids, and the incidence of serious~     complications. In order to minimize the side effects of steroid therapy, different steroid~     sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and~     mycophenolate mofetil (MMF) have been used in SRNS. Whereas CNI are usually considered the~     steroid sparing drug class of first choice, rituximab is increasingly used as alternative to~     minimize CNI toxicity. Various prospective studies suggest that Rituximab, a B cell~     depleting monoclonal antibody, could be a safe and effective alternative to steroid or~     immunosuppressants to achieve and maintain remission in this population. Rituximab infusion~     have been shown to be efficacious for 6 to 12 months and the side effect profile observed to~     date is very benign. Studies comparing the usefulness of these agents are lacking. In this~     proposed randomized controlled trial, the investigators want to compare the efficacy and~     safety of CNI to that of Rituximab in treating children with SRNS.~   "
51543|NCT02382562|"~     Depression and other unhealthy behaviors, such as not taking medication as prescribed and~     not attending doctor visits have been suggested to increase the worsening of allergic~     diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral~     intervention is effective in helping with depression and controlling disease symptoms. We~     will measure this using pre- and post-intervention surveys.~   "
51544|NCT02382549|"~     This study evaluates whether it is safe to administer a helper peptide vaccine with~     dabrafenib and trametinib. This study will also evaluate the effects of the combination of~     the peptide vaccine and dabrafenib and trametinib on the immune system. We will monitor~     these effects by performing tests in the laboratory on participants' blood, a lymph node,~     and tumor samples.~   "
51545|NCT02382536|"~     The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid~     going through the tubing) and leakage (observation of fluid on and around the device) during~     and after subcutaneous infusion using two types of infusion sets. One infusion set is~     investigational, developed by BD, and the other is the Quick-set (Medtronic), which is~     commercially available. These infusion sets will be used with a commercially available~     insulin pump to deliver insulin diluent (an inactive liquid with no medication) for~     approximately 4 1/2 hours. During this time pressure and leakage will be continuously~     monitored.~   "
51546|NCT02382523|"~     IgA nephropathy occurs when IgA—a protein that helps the body fight infections—settles in~     the kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the~     urine. Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage.~     Current treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE)~     inhibitor medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the~     angiotensin converting enzyme so that blood vessels can be relaxed.~      This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely~     given for high blood pressure).~      In previous clinical studies, some subjects with IgA nephropathy have experienced reductions~     in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug~     Administration (FDA) and used to treat patients with proteinuria.~      The purpose is to study the safety and effectiveness of the study drug Acthar given at~     different doses.~   "
51547|NCT02382510|"~     This multiple ascending dose study is to determine the safety and bronchodilator activity of~     TRN-157 in 59 mild and moderate asthmatics.~   "
51548|NCT02382497|"~     The present study grounds on the possible role of hemispheric lateralization in Eating~     disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa~     (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food~     craving behaviors.~      Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal~     cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric~     balance in AN patients, re-establish control over eating behaviors. On the contrary, active~     excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting~     inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing~     cravings/appetite binge eating behaviors.~   "
51549|NCT02382484|"~     The purpose of this study is to test whether the A-V sequential pacing strategy shown to~     effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure~     acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg)~     despite medical treatments.~   "
51550|NCT02382471|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with~     cardiovascular disease.~   "
51551|NCT02382458|"~     Diet plays a central role in the regulation of chronic inflammation. However, until the~     investigators developed the dietary inflammatory index (DII) there had been no~     scientifically valid way to relate what individuals eat to the capacity of foods consumed to~     modulate inflammation. The DII provides a tool that will form the basis of a~     counseling/instructional system aimed at helping patients and their providers to control~     chronic, systemic inflammation by improving the diet with specific, actionable dietary~     recommendations, counseling, and expert instruction. The goal of this study is to test the~     applicability of a DII mobile tool and associated counseling measures in clinical practice.~   "
51552|NCT02382445|"~     Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent~     cognitive deficits with or without evoking postoperative delirium. In animal trials various~     anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular~     substance of pathophysiologic brain tissues of demented patients. The amount of those~     markers seems to correlate well with the degree of dementia [1]. In contradiction, a single~     study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if~     hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic~     drug load, since this would have clarified if the amount of anesthetics used is associated~     to POCD and dementia. Another possibility is that stress and noxious stimulation induced by~     light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits~     implicit memory.~      The investigators' prospective randomized trial is underway to verify the impact of~     anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative~     cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a~     90 day period.~      The investigators' hypothesis is that the incidence of POCD and delirium and the degree of~     early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the~     BIS- guided anesthesia group with the superficial but sufficient anesthesia level.~   "
51553|NCT02382432|"~     This study evaluated the effect of dexmedetomidine iv in three different doses in the~     treatment of shivering in patients undergoing minor elective abdominal surgery under spinal~     anesthesia, in comparison with intravenous pethidine.~   "
51554|NCT02382419|"~     This randomized phase II trial studies how well carrageenan-containing gel (vaginal gel)~     works in reducing the rate of human papilloma virus (HPV) infection in healthy participants.~     Carrageenans, which are naturally derived from seaweed, are enhancements to natural~     lubrication and may be effective in blocking HPV infection.~   "
51555|NCT02382406|"~     This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study~     will take place in two phases. First, a cohort of twelve participants will be enrolled in~     phase I and will be treated with carboplatin, nab-paclitaxel and MK-3475 and evaluated for~     safety and tolerability after 2 cycles of therapy. If needed, a second cohort of twelve~     participants will be enrolled. Following successful completion of the dose-finding/safety~     run-in cohort, the study will proceed to phase II.~      Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for~     all participants (only if adequate archived samples are unavailable). Mandatory tumor~     biopsies will be obtained in the phase II part of the study after 4 cycles or at the time of~     progression, whichever comes first.~      The phase II part of the study is a single arm study. All participants will be treated with~     carboplatin, nab-paclitaxel, and MK-3475 at the recommended phase II dose (RP2D) in 21-day~     cycles for up to 4 cycles. Participants will be evaluated for response every 2 cycles (6~     weeks).~      For participants without progression of disease after Cycle 4, MK-3475 will continue every 3~     weeks for up to 2 years or until unacceptable toxicity.~   "
51556|NCT02382393|"~     The purpose of this study is to evaluate the concurrent validity (correlation coefficient of~     scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a~     validated third party computerized assessment.~   "
51557|NCT02382380|"~     This study is for individuals with decreased kidney function whose doctor has ordered~     Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients~     usually do not receive the intravenous contrast material that can improve the accuracy of~     the MRI findings. The purpose of this study is to evaluate the safety and benefit of using a~     contrast material called Gadoterate in patients with decreased kidney function.~   "
51558|NCT02382367|"~     The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin~     quantitative and functional deficiency in an adult French population presenting with~     pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative~     and/or functional deficiency will be displayed.~   "
51559|NCT02382354|"~     Structural differences of supraglottic airway devices could influence the different~     compressive forces in the oropharyngeal cavities, and require different depth of anesthesia.~     The addition of remifentanil during propofol anesthesia facilitates the insertion of~     laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was~     designed to determine the effect-site concentration of remifentanil in 50% of patients~     (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA~     insertion during propofol target-controlled infusion (TCI).~   "
51560|NCT02382341|"~     The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as~     measured by CT scans. Patients' improvement in pain and function will also be followed~     through various outcome measures.~   "
51561|NCT02382328|"~     The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid~     before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.~   "
51562|NCT02382315|"~     Fear of cancer recurrence (FCR) is one of the most frequently cited unmet needs among~     survivors, and affects 22 to 87% of cancer patients. The objective of this study is to test~     the effectiveness of a six weekly, 1-hour manual-based individual therapy to reduce FCR~     among cancer survivors. A total of n=20 cancer survivors will be recruited from the Ottawa~     Hospital Cancer Centre (TOHCC) in Ottawa, Ontario. Participants will be randomly selected to~     receive either the psychotherapy intervention or standard care at TOHCC. All participants~     will be asked to complete a series of questionnaire packages at 3 time points. Ultimately,~     decreasing FCR can improve quality of life and reduce distress.The objective of this RCT~     study is to test the effectiveness of a six weekly, 1 hour manual-based~     cognitive-existential (CE) individual intervention to reduce FCR among cancer survivors. It~     is hypothesized that:~        1. Participants in the intervention group will have lower scores on the primary outcome~          measure of FCR after treatment, as compared to a standard care control group~        2. Participants in the intervention group will have lower scores on the secondary outcome~          measures of uncertainty, cancer-specific distress, intolerance of uncertainty, and~          faulty beliefs about worrying, will demonstrate enhanced coping skills, and report~          better quality of life after treatment, as compared to a standard care control group,~          and these changes will be maintained at a 3-month follow-up.~   "
51563|NCT02382302|"~     This trial is a prospective research to evaluate efficiency in U-health solution service~     based on Mobile for the chronic wound management.~   "
51566|NCT02382263|"~     In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the~     6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000~     deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the~     USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%,~     respectively. Most patients are diagnosed in advanced stages that are no longer operable, so~     that treatment goals are often the prolongation of survival and palliation of symptoms.~      The aim of the study is to explore whether the new combination nab-paclitaxel plus~     gemcitabine is a therapeutic advance for this fragile population for which it is assumed~     that some modifications in dose and schedule of administration may be necessary in patients~     with good performance status. It is ultimately to find out the clinical benefit of this~     combination, but first making sure that dose and schedule of the combination are tolerable~     for these fragile patients.~      For this, the investigators have chosen a design that includes two stages: the first step~     aimed at choosing the safest treatment regimen for these patients among a group of treatment~     regimens used in other clinical trials. The second step will evaluate the effectiveness of~     the two regimens with the better results in the previous step.~   "
51567|NCT02382250|"~     This study is a prospective study of patients referred for coronary angiography at Bellevue~     Hospital Center and NYU Langone Medical Center. Subjects enrolled in this study will~     complete two one-page questionnaires, including information about diet, lifestyle,~     perceptions of health and perceived barriers to healthy lifestyles. Patients will be~     contacted at one and six months following their procedure to complete follow-up~     questionnaires to assess changes in diet and perceptions of their health after knowing the~     results of their coronary angiogram. The primary outcome measure will be change in dietary~     patterns/perception of lifestyle between baseline and one- month and six-month follow-up.~     Secondary measures will include association between dietary patterns/perception of lifestyle~     and degree of CAD and socioeconomic status.~   "
51568|NCT02382237|"~     Evaluate the feasability to determine the difference of tumoral metabolism before and after~     artificial nutrition.~   "
51569|NCT02382224|"~     The purpose of this study is to examine the efficacy of a worry exposure intervention, a~     form of cognitive behavioral therapy (CBT), in comparison to a waitlist condition for the~     treatment of Generalized Anxiety Disorder. There will be a total of 60 subjects enrolled at~     the University of Texas at Austin. Patients will be randomized (like a flip of a coin) to~     either 12-sessions of WE therapy or a 12-week waitlist before being offered entry into~     therapy.~   "
51570|NCT02382211|"~     The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T~     cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT~     platform technology can be applied to diagnose and monitor any major disease process driven~     by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the~     T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).~   "
51571|NCT02382198|"~     Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in~     25% of PD patients. Currently, there is no intervention approved for sialorrhea in~     Parkinsons and evidence is only available for a 30-day effect or less. We hypothesize that~     glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.~   "
51572|NCT02382185|"~     Improving or maximising cardiac output in the perioperative setting through the use of goal~     directed fluid therapy has been shown to reduce complications and length of hospital stay in~     patients undergoing major abdominal surgery. The evidence for patients having surgery to~     repair a fractured neck of femur is less robust but many of these latter patients are~     elderly and often at high risk of complications.~      Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia~     have not had access to goal directed fluid therapy because of the invasive nature of the~     existing monitoring technology such as oesophageal doppler. The availability of a non~     invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a~     possibility for this group of patients.~      This is a randomised controlled, observer blinded trial to assess the effects of goal~     directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral~     fractures.~      The aim of the trial is to test the hypothesis that maximising circulating volume~     intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk~     patients undergoing urgent surgical repair of proximal femoral fractures.~   "
51573|NCT02382172|"~     Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to~     and following a group based clinical therapy program to determine the effectiveness of the~     therapy approach. The therapy program is aimed at improving social cognitions and skills of~     individuals who find social situations difficult, stressful and/or uncomfortable and with a~     desire to enhance skills required for social interactions.~      Participants: Cohorts of individuals aged 10-69 years old with symptoms of a~     neurodevelopment disorder, who have general difficulty with social interactions.~      Procedures: Participants enrolled in a clinical therapy program for improvement of social~     cognitions and skills will complete eye tracking tasks, several questionnaires and rating~     scales, and a diagnostic interview prior to and following the 8 week therapy program. The~     post treatment assessments will be conducted within a week of the therapy completion and~     then again approximately 2 months after the last therapy session. The entire study duration~     is expected to be approximately 17 weeks. These outcome measures will measure the~     effectiveness of the treatment.~   "
51574|NCT02382159|"~     1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who~          has done exogenous visit or hospitalization from Jan 2010 to June 2014.~        2. Study objective:~             1. The objective of this study is to Identifying the lipid parameter variation when~               treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.~             2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months,~               identifying the reason why changing method of drug dosage and pharmacotherapy.~             3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid~               parameter variation when treating patients by altered drugs for 3±1 months,~   "
51575|NCT02382146|"~     We designed this randomized, double- blind, single-center study to compare the efficacy of~     the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate~     undergoing plastic surgery.~   "
51576|NCT02382133|"~     Continuous pulse oximetry monitoring is the standard of care in critically ill patients in~     emergency departments, operating rooms and intensive care units. In patients with poor~     peripheral perfusion (low blood flow) due to peripheral vascular disease, low body~     temperature, or shock and the use of medications to raise the blood pressure, clinicians~     have difficulty obtaining an accurate measurement. This study compares the accuracy of~     forehead oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of~     device related pressure ulcers with both.~   "
51577|NCT02382120|"~     Cardiac output monitoring is mandatory in most surgical and critical care patients. Many~     techniques to assess cardiac output are invasive and/or have many limitations,~     contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal~     is an interesting option due to the simplicity and non-invasive nature of its calculation.~      The present study was designed to compare the cardiac output measurement using a~     capnodynamic formula versus the reference thermodilution method.~   "
51578|NCT02382107|"~     The diagnosis of tuberculosis (TB) and especially the detection of drug resistance of~     tuberculosis mycobacteria can be time consuming and costly. New and rapid diagnostic tests~     are needed to improve early case detection and correct initiation of treatment.~      In the planned cross-sectional diagnostic evaluation study the investigators are aiming for~     the assessment of several new TB diagnostics (e.g. new AID strip assays and TrDNA assay in~     urine) in TB suspects who are presenting themselves to the pulmonary ambulance (TB~     dispensary for sector 4) at the Marius Nasta Institute (MNI). The study will be conducted in~     a co-operation between the MNI and the German Center for Infection Research (DZIF).~   "
51579|NCT02382094|"~     Phase III clinical trial to study quality of life in prostate cancer patients by randomizing~     anti-androgen versus total androgen blockage prior to curative intended radiation therapy.~   "
51580|NCT02382081|"~     The primary objective of this research protocol is to evaluate the health related quality of~     life and efficacy of patient-initiated hospital follow-up for patients with moderate to~     severe psoriasis.~   "
51581|NCT02382068|"~     This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in~     patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum~     before chemotherapy may help protect against cisplatin-associated hearing loss.~   "
51582|NCT02382055|"~     The investigators are examining what types of psychotherapy are most helpful for patients as~     they undergo weight restoration treatment for anorexia nervosa. In this study, patients who~     are receiving care on our inpatient unit will also receive 4 weeks of one two types of~     psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.~   "
51583|NCT02381964|"~     When completing difficult tasks, the brain requires faster delivery of energy sources~     (oxygen and glucose) via the blood. There is evidence to suggest that some nutritional~     supplements may increase blood circulation in the brain which can result in improved task~     performance. The purpose of the study is to evaluate the effects of a multivitamin/mineral~     preparation (containing a range of vitamins and minerals as contained in commonly consumed~     multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood~     flow and energy expenditure during cognitive task performance.~   "
51584|NCT02381951|"~     Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy~     (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial~     'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing~     gait and walking.~      Spinal cord stimulation is currently an important therapeutic option in the treatment of~     neuropathic pain. Experimental and limited clinical data suggest that this technique might~     also be used to alleviate motor symptoms and improve walking in Parkinsons patients.~      This exploratory study aims at measuring the benefits of spinal cord stimulation on the~     walking capacity of a small number of Parkinsons patients who are not adequately improved by~     drug therapy alone.~   "
51585|NCT02381938|"~     This study will evaluate the efficacy of a 6-month child care-based intervention to improve~     workers' physical activity and other health-related behaviors compared to an attention~     control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a~     cluster randomized design and a sample of 104 child care centers and 416 child care workers~     (4 workers/center). The intervention arm will receive a 6-month child care-based~     intervention designed to improve workers' moderate to vigorous physical activity (MVPA) and~     other health-related behaviors (Healthy Lifestyles). The control arm (attention control)~     will receive a similarly structured program about financial health (Healthy Finances). The~     primary outcome is workers' MVPA; and secondary outcomes include workers' dietary intake,~     weight, smoking, sleep, and stress, as well as the centers' health supportive~     policies/structures for staff wellness and the overall physical activity environment for~     children. All primary and secondary outcomes will be assessed at baseline, post-intervention~     (6 months), and maintenance (18 months).~   "
51586|NCT02381925|"~     The study aims are:~        1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT),~          scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary~          hyperparathyroidism.~        2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused~          parathyroidectomy, and for rates of persistent hyperparathyroidism and complications~          from parathyroid surgery.~      Methods The investigators will create a multicenter registry consisting of patients having~     parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial~     participating centers include Duke University Medical Center, University California Los~     Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).~      There will be no intervention in the patient's treatment or imaging. The management will be~     determined by the surgeon or clinician supervising the patient's care.~      The registry will consist of patient data regarding basic demographics, history of prior~     neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative~     surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months~     (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be~     entered into REDCap with no PHI. The investigators expect to include 3000 patients in the~     registry (1000 from Duke).~   "
51588|NCT02381899|"~     The purpose of this observational study is to provide additional data to confirm the safety~     profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic~     leukemia patients treated in routine clinical practice.~   "
51591|NCT02381860|"~     Scientific studies in humans suggest that diets high in fruit and vegetables may be able to~     improve some aspects of mental performance such as improving memory and reaction times. One~     reason that that these improvements may occur is that these compounds contain phytochemicals~     which may increase blood flow and, therefore, the delivery of oxygen and nutrients to the~     brain. If this is the case it is possible to measure this increased blood flow by a~     non-invasive technique called Near Infrared Spectroscopy. The purpose of this study is to~     examine the effect of a fruit juice on cerebral blood flow and cognitive function~   "
51592|NCT02381847|"~     Patients with histological proven advanced gastric cancer (including cancer of the~     esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the~     inclusion and exclusion criteria, can be recruited in this study. There are two treatment~     groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients~     randomized into group B will be treated with an intraperitoneal (in the abdominal cavity)~     chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group~     A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles~     of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure~     and are followed up for 24 months.~   "
51593|NCT02381834|"~     Urinalysis and urine culture are commonly employed laboratory tests in the Emergency~     Department (ED), particularly for the purposes of investigating febrile infants in whom~     bacterial etiologies must be ruled out. The standard of care for obtaining sterile urine~     specimens in this age group remains transurethral bladder catheterization, an invasive~     procedure that is painful and has the potential for causing specimen contamination and~     iatrogenic urinary tract infection (UTI). A recent study by Herreros Fernández et al (2013)~     described a novel bladder stimulation technique for newborns that facilitates midstream~     urine collection. The success rate for this procedure was 86.3%. It remains unknown however~     as to whether this technique is reproducible amongst infants who present to the ED with a~     potentially greater severity of illness. The primary objective of this study is to determine~     the success rate of this technique in children ≤ 90 days old in the ED.~   "
51594|NCT02381821|"~     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These~     patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a~     3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed~     up after treatment to determine the rate of implantation.~      Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the~     junctional zone at day 21 of the cycle.~   "
51595|NCT02381808|"~     To understand 286 gene mutation mutation rates (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect)~     by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships~     with the patients' clinical features (including sex, age, smoking history and adenocarcinoma~     subtype), specify the predictive significance of the genes mutations for new targeted~     therapies in NSCLC patients, and better understand the molecular mechanism drug resistance~     to EGFR-TKIs.~   "
51596|NCT02381795|"~     This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate~     in the study and meeting the eligibility criteria assessed at the screening visit will be~     enrolled in the study. The length of time between screening and treatment will last between~     0 days to a maximum of 12 weeks. Subjects who enter the screening phase during a cluster~     headache episode and meet the study eligibility criteria can immediately enter the treatment~     phase and may opt to treat their cluster headache episode in the clinic. Subjects who are~     not in a cluster headache episode, who meet initial screening eligibility criteria, can~     remain in the screening phase for up to 12 weeks until their next cluster episode begins.~     Upon initiation of a cluster headache episode, subjects will enter the treatment period.~     Subjects will be trained on the proper use of the hand-held dispenser containing carbon~     dioxide (CO2 )calibrated to deliver 0.5 standard liters per minute (SLPM). This dispenser~     will be provided for use in the clinic or home. Subjects will be instructed to use the nasal~     CO2 dispenser, 10 seconds/nostril, as needed up to 6 times to treat one attack. Each dose~     must be separated by 3-5 minutes. Subjects should treat only one attack in a 24-hour period.~     Subjects may treat up to three cluster headache attacks during the treatment phase of this~     study. One hour after the first dose, subjects can choose to treat with~     investigator-approved rescue medication. Subjects will be asked to complete an online diary~     after the completion of the dosing. Diary assessments will collect pain severity, nasal CO2~     usage, acute medication usage, satisfaction of treatment, number of cluster attacks, and~     unusual symptoms. Subjects will be contacted by phone within 3 days of the first use of the~     nasal CO2 dispenser to assess adverse events (AEs) and medication usage. A total of 25~     subjects will enter the treatment period and be instructed to treat up to 3 cluster~     headaches with nasal CO2. Within 7 days of treating their last cluster headache episode,~     subjects will return for an end of study visit.~   "
51597|NCT02381782|"~     Over the last few years, there has been a considerable interest in the development of~     screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer~     treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment~     of co-morbid conditions that are likely to interfere with cancer treatment and tolerability.~     As presbyacusis is common in an older population, elderly cancer patients are at high risk~     for social isolation and a reduced quality of life. Therefore, in this project the~     investigators aim to validatie uHear™ as a quick and reliable screening tool to screen for~     presbyacusisf in routine clinical oncology practice.~   "
51598|NCT02381769|"~     The study will be an experimental pre-post trial in which patients with ethanol related~     liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute~     from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would~     receive polymeric blenderized kitchen based liquid diet while those tolerating orally would~     receive soft/ solid diet as tolerated as per requirement. All the patients would receive~     same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein.~     35-40% of non protein calorie would be provided as fats and rest of the calories will be~     provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day~     for 3 consecutive days, over and above the feed provided to them to be taken enterally~     (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours~     after infusion.~   "
51599|NCT02381756|"~     The aim of this study is to evaluate, in an intensive care unit, the reproducibility between~     two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson~     method and of the calculation of GLS for the evaluation of the systolic function of the left~     ventricle in critically ill patients intubated and ventilated.~   "
51629|NCT02381366|"~     PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord~     blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular~     therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an~     open-label, single-center, dose escalation study to evaluate of safety and efficacy of~     PNEUMOSTEM® in premature infants at high risk for BPD.~   "
53565|NCT02355990|"~     The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy~     (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.~   "
51600|NCT02381743|"~     Community health workers (CHWs) provide essential basic medical care to hundreds of millions~     of people across the globe. CHWs offer a myriad of services including community sanitation,~     breast feeding counseling, family planning, management of febrile children, and malaria~     control and prevention, to name but a few. In fact, CHWs are often the only source of~     primary health care available to some of the most disadvantaged populations in the world.~     However, to be effective, CHWs must be trained - and retrained - at regular intervals, and~     the costs for such trainings can be substantial. In the US, clinicians are required to stay~     current and maintain their competence through continuing medical education (CME).~     Increasingly, CME activities are delivered via internet-based, self-teaching modules. A~     typical example would be a set of topical readings followed by multiple-choice questions,~     with the answers, and CME credit, provided to the user upon satisfactory completion of the~     module. This content is typically delivered over the Internet. However, there is no~     intrinsic reason why this approach could not be adapted so that CME activities are delivered~     using standard cell phones via SMS text messaging. This would significantly expand~     professional training opportunities to a far greater range of CHWs than possible through~     computer/tablet/smart phone platforms, and would be particularly valuable in poorer~     countries with limited training budgets. In the mCME project, the investigators propose to~     test the effectiveness and cost effectiveness of a mobile phone-based CME delivery strategy~     among Vietnamese community-based physician assistants (CBPAs), a cadre of CHW mandated to~     provide primary health care to rural and disadvantaged populations. The investigators~     hypothesize that providing CME activities over a mobile platform will significantly improve~     their professional knowledge, and may also improve their job satisfaction and self-efficacy.~   "
51601|NCT02381730|"~     Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is~     often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV~     response to anti-vascular agents differs from the response of typical AMD.~      This study aims at describing the evolution of the best corrected visual acuity (BCVA) in~     PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).~   "
51602|NCT02381717|"~     The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided~     Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of~     parenteral injection of opioid pain medication in patients presenting to the emergency~     department (ED) with hip fracture.~   "
51603|NCT02381704|"~     The overall purpose of the study is to determine prospectively the cost effectiveness of~     bariatric surgery following partial coverage by a large healthcare system.~   "
51604|NCT02381691|"~     Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates~     Design : A prospective, randomised, controlled, double blinded, monocentric trial.~      Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were:~     neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea~     and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th~     percentile according to Olsen curves et al. They also had to be: clinically stable, with 48~     hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in~     the last 48 hours and without any underlying disease. The two legal representatives must~     have signed an informed consent. The study excluded the neonates for whom no video was~     recorded during the venipuncture.~      In the first group breast milk, venipuncture was performed to the neonate while his~     mother's milk odor was being diffused. In a second control group, the same gesture was made~     with an odorless diffusor. The primary outcome was the clinical score assessment PIPP~     (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of~     Newborn) and the salivary cortisol level.~   "
51605|NCT02381678|"~     The objective of the study is to obtain the clinical data from patients who had the~     Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital~     during 2001-2007 in order to evaluate the performace of this heart valve prothesis and~     collect the patients' post-operation infomation including the current living status,~     mortality rate, and the possibility of re-operation，bleeding and thrombosis.~      This is a retrospective , observentional clinical study to be conducted in Guangdong General~     Hospital in China. This study will enroll up to 200 patients.~   "
51606|NCT02381665|"~     Chronic constipation is a strong public health problem. Its prevalence is about 15% in~     Western countries with a significant impact on quality of life and health care costs . Two~     subtypes of constipation can be identified: slow transit constipation (STC), characterized~     by impaired propulsion of stool and due to dysfunction of colonic smooth muscle (myopathy)~     or its innervation (neuropathy), or both; and evacuation disorders, characterized by~     difficulty or inability with stool expulsion. They include disorders of the anorectal~     function such as dyssynergic defecation, as well as structural disorders such as rectocele,~     descending perineum syndrome and rectal prolapse .~      The first line therapy of chronic constipation is based on medical treatment combined with~     laxatives and dietary rules. However, these treatments are often disappointing. In case of~     failure, few treatment options are currently available. Surgery can sometimes be discussed~     for intractable chronic constipation. Sub-total colectomy can be proposed in case of STC but~     is associated with a significant morbidity. In case of pelvic floor disorders, a specific~     surgical treatment can be indicated. However, surgery is invasive, has a significant~     morbidity and the results are inconsistent. Recently, some studies have assessed the~     efficacy of sacral neuromodulation in the treatment of chronic constipation with some~     success, but this technique is expensive and requires the surgical implantation of a medical~     device . More recent works, including a randomized trial have showed, in children, the~     efficacy of interferential current stimulation in the treatment of chronic transit~     constipation . This treatment is used daily, at home, and uses four adhesive surface~     electrodes, two abdominal (placed below the costal margin) and two paraspinal (placed~     between T9 and L2) producing two sinusoidal currents crossing the body, 1 hour per day for~     1-3 months. To date, only one open-label study has evaluated this technique in adults and~     has shown encouraging results in three months with an efficiency on 7/11 patients (63.6%) in~     the number of stools, severity score of constipation, quality of life's score associated~     with improved bowel transit time measured by radio-markers.~      Interferential therapy is a new treatment that has demonstrated its efficiency in the~     treatment of chronic constipation in children. Our team has published the first and only~     pilot study in adults that also demonstrated encouraging results. These data are of~     particular interest since laxative treatments are often disappointing, are expensive and may~     have adverse events.~      This study would be the first randomized study to evaluate a non-invasive and~     non-pharmacological treatment of chronic constipation in adults.~      If its effectiveness is demonstrated, it will provide, for the first time, a new~     non-invasive step for patients with laxative treatment failure before considering surgical~     treatment.~   "
51607|NCT02381652|"~     The objective of this study is to evaluate the safety of a repeat injection of Cingal® in~     subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01. This will be~     done through examination of the incidence of adverse events and physical examination of the~     knee.~   "
51608|NCT02381639|"~     The current etiological pathological model of anorexia nervosa is poly-factorial involving~     individual genetic and psychological factors, in close interaction with environmental,~     family and socio-cultural factors.~      Among these factors, this study focuses on the central coherence process (cognitive ability~     to integrate complex information into a comprehensive meaning), in the active phase of the~     disease. Therefore, patients followed in the addiction service of the Nantes University~     Hospital will perform neuropsychological tests assessing executive functions involved in the~     process of central coherence.~      Impairment of central coherence process could act as a maintenance factor of the disease,~     particularly in connection with body dysmorphic disorder. The therapeutic perspectives~     acting on the central coherence process like cognitive remediation deserve to deepen~     knowledge on the cognitive profile of patients with anorexia nervosa.~   "
51609|NCT02381626|"~     The purpose of this study is to look at air quality in cabs and see if the air quality~     inside taxi cabs is connected to increased risks for lung and heart health problems. Another~     purpose of the study is to see if putting an air filter inside the car may help improve the~     air quality and lower health risks.~      This is important because air pollution can be harmful to health. Air pollution is made up~     of very tiny particles (things) floating in the air around us, called particulate matter.~     Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our~     bodies as we breathe. It has been linked to risk for lung cancer and heart disease. It is~     important because taxi drivers spend many hours of their day inside their cars.~      The investigators hope that this study will help them find out if using air filters inside~     cabs will help lower the levels of pollution in cabs and reduce its effects on the health of~     taxi drivers. They will use these results to educate the taxi driver community.~   "
51610|NCT02381613|"~     While observational studies often find that diets rich in fish reduce the risk of disease,~     and that diets including a high intake of red meat are associated with increased risk of~     cardiovascular disease and cancer, the difference in health effects between red meat and~     fish are rarely researched in intervention studies.~      The investigators hypothesise that the post-prandial plasma response of lipids and markers~     of cardiovascular disease risk will be more favourable after intake of herring compared to~     beef.~      In addition, while pickling herring in a brine/sugar solution is a common form of~     preparation, little is known if there is a difference in potential health effects based on~     the preparation of herring. The investigators will compare baked and pickled herring to~     understand if preparation is potentially an important factor to be considered when looking~     at intake of fish and health.~   "
51611|NCT02381600|"~     Background: Ageing is associated with an increased risk of cognitive decline and depression.~     Vitamin D plays an important role in many of the symptoms and conditions related to advanced~     age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological~     effect on the function of the central nervous system, and studies have suggested a~     relationship between this vitamin and changes in affect and cognitive function in the~     elderly. The investigators propose a pilot study to examine the relationship between~     below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in~     the elderly.~      Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH~     Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the~     treating family physicianfor screening. Subjects will be required to provide written~     informed consent for inclusion in the study. Exclusion criteria will include any active or~     unstable medical condition as determined by the treating physician, known neurocognitive~     disorder, known affective disorder, the use of any class of antidepressant drugs, the use of~     supplements containing vitamin D in any dose, significant visual or hearing impairment not~     corrected by spectacles or hearing aids, and a level of literacy that limits cognitive~     ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized~     cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive~     assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo~     repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed~     patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered~     by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for~     level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax~     Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).~   "
51612|NCT02381587|"~     sjogren syndrome is an autoimmune disease that mainly affects the Salivary glands and~     Lacrimal gland In addition to the effects of this disease is characterized by overall~     systemic Muskals injury, pulmonary disease, peripheral neuropathy and vasculitis. In~     addition recent studies have shown that patients are at increased risk of the disease up to~     2 cardiac events and stroke events Hydroxychloroquine is an RHEUMATIC DISEASE PROCESS~     SUPPRESSANTS-ANTIMALARIALS used to treat anti-inflammatory rheumatic diseases in many~     first-line treatment is sjogren syndrome.~      A recent study of the treatment in Hydroxychloroquine effect on lipid profile sjogren~     syndrome patients showed a reduction in total cholesterol levels and increase in HDL.~     Further studies of the impact made Hydroxychloroquine systemic lupus patients erythematosus~     (SLE) showed in Atherosclerosis and morbidity and mortality reduction in cardiovascular.~     Studies of patients with rheumatoid arthritis (RA) demonstrated reduced risk of developing~     diabetes and improved lipid profile Research Goals valuate The effect of HCQ treatment in~     cardiovascular patients with primary sjogren syndrome~   "
51613|NCT02381574|"~     Primary Objective:~      To evaluate the rate of re-operation during the first 5 years following the fitting of~     lumbar total disk replacement at the operated level and / or floors above and / or~     underlying, whatever the reasons~   "
51614|NCT02381561|"~     This phase I trial studies the side effects and best dose of ropidoxuridine in treating~     patients with gastrointestinal cancer that have spread to other places in the body and~     usually cannot be cured or controlled with treatment undergoing radiation therapy.~     Ropidoxuridine may help radiation therapy work better by making tumor cells more sensitive~     to the radiation therapy.~   "
51615|NCT02381548|"~     This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 and~     belinostat when given together in treating patients with myeloid malignancies that have~     returned after a period of improvement or have not responded to previous treatment or~     patients with untreated acute myeloid leukemia. WEE1 inhibitor AZD1775 and belinostat may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
51616|NCT02381535|"~     This phase I trial studies the side effects and best dose of heat shock protein-90 (Hsp90)~     inhibitor AT13387 when given together with intensity-modulated radiation therapy (IMRT) and~     cisplatin in treating patients with squamous cell carcinoma of the head and neck that has~     spread from where it started to nearby tissue or lymph nodes. Hsp90 inhibitor AT13387 works~     by blocking a protein called HSP90. HSP90 helps protect cells from stress and supports many~     other proteins that cause cell growth. When HSP90 is blocked, tumor cell growth may be~     slowed or stopped and may die more easily when treated with chemotherapy and radiation.~     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. IMRT is a specialized radiation therapy that delivers beams of~     radiation of different intensities aimed at the tumor from many angles and may kill more~     tumor cells and cause less damage to normal tissue. Giving Hsp90 inhibitor AT13387 with~     cisplatin and IMRT may kill more tumor cells.~   "
51617|NCT02381522|"~     The purpose of the study is to investigate if briefly stopping blood flow to the patient's~     leg will lead to the patient's body being better able to tolerate possible decreased blood~     flow to regions of the brain which otherwise frequently happens after subarachnoid~     hemorrhage.~      Previous studies show that various organs such as the heart, brain or kidney can tolerate~     longer periods of decreased blood flow if prior to that insult shorter periods of decreased~     blood flow were experienced.~   "
51618|NCT02381509|"~     PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of~     commercially available IVC filters from 6 manufacturers placed in subjects for the~     prevention of pulmonary embolism (PE). This study will enroll approximately 1,800 IVC filter~     subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure,~     3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The~     primary objective of this investigational device exemption (IDE) clinical investigation is~     to evaluate the safety and effectiveness of the commercially available IVC filters~     (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE~     with an IVC filter.~   "
51619|NCT02381496|"~     This is a three-part study to assess the tolerability, safety, pharmacodynamics, and~     pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in~     healthy male subjects, of ascending multiple doses of ACT-453859 in healthy male and female~     subjects, and of multiple doses of setipiprant (ACT-129968) in healthy male and female~     subjects.~   "
51620|NCT02381483|"~     Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical~     studies, however the role of retinoids in human brown fat physiology and energy metabolism~     remains elusive. This study aims to identify a possible association between retinoid~     metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using~     FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic~     profile of white and brown neck fat biopsies at room temperature and cold conditions in a~     subset of the study participants. More detailed molecular studies (involving other potential~     browning markers) will also be performed in adipocytes derived from human SVC.~      The optimal duration of cold exposure will be determined in a pilot study. Therefore~     subjects will be repeatedly exposed to cold and circulating retinoid levels and other plasma~     parameters will be measured at various time points.~   "
51621|NCT02381470|"~     Faropenem is an oral penem, closely related to the carbapenem class that is used for the~     treatment of bacterial infections. It has in vitro activity against Mycobacterium~     tuberculosis and this trial aims to determine the activity of faropenem with~     amoxicillin/clavulanic acid in patients with pulmonary TB.~   "
51622|NCT02381457|"~     This multi-center prospective observational study is designed to track birth outcomes and~     perinatal correlates to the Panorama prenatal screening test in the general population among~     ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy~     screening as part of their routine care. The primary objective is to evaluate the~     performance of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing~     (NIPT) for 22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women.~     This will be done by performing a review of perinatal medical records and obtaining~     biospecimens after birth to perform genetic diagnostic testing for 22q11.2 deletion. Results~     from the follow-up specimens will be compared to those obtained by the Panorama screening~     test to determine test performance. Specific test performance parameters will include: PPV,~     specificity, and sensitivity.~   "
51623|NCT02381444|"~     The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on~     HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality~     of Life between participants continuing to levodopa-carbidopa intestinal gel treatments~     versus participants continuing on oral therapy for Parkinson's Disease.~   "
51624|NCT02381431|"~     The purpose of this study is to see if thermal images can be used instead of a chest x-ray~     to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur,~     India. More specifically, the objectives of the study are: 1) to determine if thermal~     imaging, using a commercial thermal camera can accurately detect the presence of bacterial~     pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use~     of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed~     with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of~     infection that are suspected to be related to the pneumonia.~   "
51625|NCT02381418|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. The current study is a phase III A clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The~     objective of this study is to investigate the immunogenicity and safety and tolerability of~     the changed influenza vaccine virus composition in two groups of subjects in good health:~     subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).~   "
51626|NCT02381405|"~     This is an open label, randomized investigation of a proprietary blend of amino acids,~     called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy~     and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or~     continue standard of care. Two patients will be enrolled on the treatment arm for each~     patient on the control arm.~   "
51627|NCT02381392|"~     Obtaining intravenous (IV) access in children under the age of 2 years is difficult,~     especially in the emergency department (ED) where the children can be frightened, dehydrated~     and ill. Often it requires multiple needle sticks and nurses to place an IV in a difficult~     child. In our ED the recently acquired an Accuvein AV400 device. This infrared light, like a~     barcode scanner, makes the veins on a child appear like roads on a map. This ideally shows~     the nurse where to place and direct the needle. This device is approved by the FDA to work~     with children and has not been shown to have any harmful effects. However, there are no~     studies showing whether this device helps in the difficult less than 2 year olds seen in the~     emergency department.~      This study will be to directly compare placing an IV in a child under 2 years of age with~     the AV400 versus not using the device. A physician, medical student, or nurse practitioner~     who has been trained on how to observe nurses place IVs will enroll children who require an~     IV for their ED clinical care (as determined by their ED doctors). This person will consent~     the parents, ask the parents questions regarding the child's past medical history, and have~     the nurse look at the veins of the child ahead of the IV access attempt to rate the level of~     difficulty expected (easy, moderate, difficult). Whether the child has the IV attempt~     performed with or without the AV400 will be computer randomized. The nurse will attempt to~     place the IV, and the study staff will observe and record the number of attempts, size of~     the IV catheter, and location of the IV. If 2 attempts are failed, the patient will cross~     over to the other condition, that is if AV400 was being used then it will not be used, and~     if AV400 was not being used then it will be used. If there are 4 failed attempts at IV~     placement, then the child will be treated as per our department's difficult IV access~     protocol, which is applied to all children with difficult IV access regardless of~     participation in the study. After the IV placement, both the parents and the nurse will be~     asked several questions regarding satisfaction with use of the AV400.~      No patient identifiers will be collected.~      The investigators will be recruiting 260 children to determine if using the AV400 device~     improves the first time needle stick success from 40% to 60%.~      Nursing approval for the study was obtained prior to the study.~   "
51628|NCT02381379|"~     To compare administration of peginterferon-α-2a for 1 year versus observation after stopping~     tyrosine kinase inhibitor (TKI) in chronic myeloid leukemia (CML) patients with deep MR ≥ 2~     years.~   "
51630|NCT02381353|"~     After surgery to remove the eye, either by enucleation or evisceration, patients have~     variable levels of pain for several postoperative days. Some patients have almost no~     discomfort while others require significant amounts of oral narcotics and report pain of 10~     out of 10 on a numerical rating scale. The current operative standard is to infiltrate the~     eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative~     analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable~     suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving~     postoperative pain control for up to 72 hours. This medication has been used in numerous~     surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast~     reconstruction, and orthopedic surgery, and the literature reports improved pain control,~     decreased use of oral opioids, and increased patient satisfaction. There are no reports of~     the use of Exparel in the ophthalmic literature. The investigators propose a randomized,~     controlled trial to compare the postoperative pain control offered by sustained release~     bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.~   "
51631|NCT02381340|"~     Obesity and its associated conditions have reached epidemic proportions. Estimates are that~     about one third of the adults in the United States have obesity. At this moment there are~     many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment~     options are limited and so far surgical intervention has been proven to be the only strategy~     to overcome severe obesity. However, bariatric surgery has limitations and risks, which~     might be minimized by non-incisional endoscopic procedures.~      BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM)~     Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which~     intends to reduce the ability of the stomach to expand by creating plications in the region~     of the fundus and greater curvature. In contrast with other bariatric surgery it is~     endoscopically performed, reversible and if it fails most future surgical options are still~     open.~      The main study ('Open, prospective study to evaluate the safety and preliminary~     effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study~     (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and~     efficacy of this plicating system for patients with severe obesity.~      In this sub-study we want to unravel the exact mechanism and provide more information about~     the efficacy of the BaroSense ACE™ Stapler. Therefore we will measure changes in various~     parameters that are known to affect weight loss and metabolism, before and after gastric~     plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters~     will only be measured in patients at MUMC+). These parameters are post-prandial satiety,~     food-reward and related brain signalling, gastric emptying, behaviour towards food, food~     intake, satiety hormone release, microbiota composition and inflammatory markers.~      Objectives:~      Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on~     postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour~     towards food, food intake, hormone release, microbiota composition and inflammatory markers.~   "
51632|NCT02381327|"~     Patients diagnosed with Binge Eating Disorder (BED) overeat food but, as opposed to patients~     with bulimia nervosa, they do not compensate for their increased food intake and therefore~     their body weight increases. It is hypothesized that the speed of eating has increased in~     BED and that body weight will decrease if the speed of eating is decreased. The speed of~     eating is measured using Mandometer, an eating disorder conditioning tool, class 2 device~     cleared by the FDA for the treatment of eating disorders. Mandometer is a scale connected to~     a computer, patients eat food from a plate on the scale and the computer stores the weight~     loss of the plate, thus recording the speed of eating. Patients decrease their speed of~     eating by following training curves on the computer screen while eating. The emergence of~     their own speed of eating on the screen makes this possible. Patients use Mandometer for~     lunch and dinner over one week at home to estimate their speed of eating and their food~     intake as the first step of clinical pratice. Mandometer is then programmed with how much~     and how quickly to eat and patients practice eating using Mandometer at home over the~     subsequent treatment. Data from 166 BED-patients using Mandometer at home and from a total~     of 354 patients who have been treated have been collected. 30 normal weight, healthy~     subjects will be recruited to test the hypothesis that their speed of eating is lower than~     that of the BED-patients. These control subjects will eat lunch and dinner using Mandometer~     at home over one week, but they will, obviously, not participate in treatment.~   "
51633|NCT02381314|"~     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination~     with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous~     cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC) and other~     B7H3 expressing cancers. The study will also evaluate what is the best dose of enoblituzumab~     to use when given with ipilimumab. Assessments will also be done to see how the drug acts in~     the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor~     activity of enoblituzumab in combination with ipilimumab.~   "
51634|NCT02381301|"~     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed~     countries. In addition, many patients suffer from valvular and aortic disease. Although~     various tools are available to identify patients with cardiovascular (CV) disease at risk~     for major adverse cardiac events (MACE), the identification of these patients remains a~     clinical challenge.~      One promising avenue is the use of different serum biomarkers involved in atherothrombosis~     which could provide an easy and cost-effective step in risk stratification.~   "
51635|NCT02381288|"~     The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6~     weeks of subcutaneous (SC) administration of different doses and dosing frequencies of~     TAK-448 to middle-aged and older men with low ST levels.~   "
51636|NCT02381275|"~     Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the~     University Köln (Cologne) would like to set up a cohort to study baseline characteristics~     and long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at~     the Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming~     to the Lighthouse to newly initiate ART will be approached to enroll in the cohort.~      The results will be disseminated both nationally at the Ministry of Health Technical Working~     Group (TWG), at the annual Research Dissemination and Best Practices conferences of the~     College of Medicine and National AIDS Commission as well as internationally. The results~     will also be written up for publication in appropriate peer-reviewed journals.~   "
51637|NCT02381262|"~     Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve~     gastrectomy surgery, the investigators would like to determine if the Fitbit is associated~     with health outcomes in this population.~      Primary Outcome~      • Percentage of excess weight loss - Does the use of a Fitbit positively affect the~     percentage of excess body weight loss in vertical sleeve gastrectomy patients?~      Secondary Outcomes~        -  Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive~          lifestyle and exercise pattern changes in post-operative VSG patients?~        -  Resolution of comorbidity - Does the use of a Fitbit positively affect patient health~          via reduction of co-morbid conditions associated with morbid obesity following VSG~          surgery?~   "
51638|NCT02381249|"~     Improvements to treatment strategies for patients with cancers of the upper gastrointestinal~     tract have produced a large population of people who remain free from cancer recurrence in~     the long term following treatment.~      Surgery is the cornerstone of treatment for patients with these cancers, but while surgical~     removal of the tumour may offer the best chance of cure, these are major operations~     associated with specific long term complications. Weight loss and poor nutrition are common~     problems among patients who attain long-term cancer remission and cure after surgery. The~     mechanisms underlying these problems are not well understood and therefore treatment options~     are limited.~      Our research has demonstrated increased levels of chemical messengers (gut hormones)~     released from the gastrointestinal tract after meals in patients who have previously~     undergone this type of surgery. These chemical messengers play a role in controlling~     appetite and interest in food, and increased levels after surgery may reduce interest in~     eating. Understanding the role of gut hormones in the control of appetite may allow us to~     use certain medications to block gut hormones and hence increase appetite, allowing patients~     to eat more and regain weight, preventing nutritional problems after surgery.~      In this study, the investigators aim to determine whether exaggerated gut hormone secretion~     causes reduced appetite and interest in food after surgery. The information gained from this~     study may help us to develop treatments for patients with weight loss and nutritional~     problems after surgery.~   "
51639|NCT02381236|"~     A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the~     perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic~     resonance imaging (mpMRI).~   "
51640|NCT02381223|"~     This study aims to collection additional data on the safety and acceptability of medical~     abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.~   "
51641|NCT02381210|"~     A cross sectional study design will evaluate the diagnostic value of the CRD test to the~     pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil~     Inguarán, tertiary level facilities in Bangladesh and Mexico City.~   "
51642|NCT02381197|"~     A population-based prospective cohort design will evaluate the progression of urine~     congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally~     across gestation in Bangladesh and Mexico City.~   "
51643|NCT02381184|"~     One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly~     into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days)~     for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary~     outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial~     thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical~     pregnancy and abortion.~   "
51644|NCT02381171|"~     To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS)~     stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture)~     treatments are more effective in pain relief than placebo-sham in patients with myofascial~     chronic pain.~   "
51645|NCT02381158|"~     This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone~     dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg~     nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in~     children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of~     symptoms and exacerbations, will be assessed.~   "
51646|NCT02381145|"~     In this double-blind, randomized, placebo-controlled study, we aim to investigate the~     effects of a long-term supplementation on insulin sensitivity, mitochondrial function and~     substrate metabolism in healthy overweight men and women.~      In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg~     Epigallocatechin-gallate (EGCG), respectively Placebo capsules, twice daily over a period of~     12 weeks. The subjects receive the capsules after the last pre-measurement and continue to~     take them throughout the post-measurements.~      Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp~     with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity.~     Simultaneously, substrate oxidation is measured throughout the clamp by indirect~     calorimetry. Furthermore, we perform a high-fat mixed meal test, in which we collect blood~     and measure substrate oxidation during fasted and postprandial conditions. During the meal~     tests, extra plasma is collected at the start (t=-30) and the end (t=240), of which the~     supernatant is stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for~     analyzing polyphenol concentrations in the blood.~      In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the~     subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and~     blood flow by means of ethanol infusion.~      Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken~     under fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis~     muscle. These samples are stored at -80C. Part of the adipose tissue samples is collected to~     measure adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and~     used for the oxygraph to measure mitochondrial function.~      At last, feces samples are collected before and after the intervention in order to assess~     energy content, microbial composition and short-chain fatty acid content.~      Based on previous human studies in our and other departments, we hypothesize that after 12~     weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial~     function improve. Furthermore, based on results of a short-term study performed by our~     group, that demonstrated an increase in energy expenditure, a positive effect on the~     regulation of body composition might be expected.~   "
51647|NCT02381132|"~     The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco®~     7.5mg/325mg when used for the treatment of moderate to severe post operative pain.~   "
51648|NCT02381119|"~     This study addresses the challenge of increasing compliance with dietary recommendations and~     guidelines among diabetes type 2 patients by introducing professional dietary advice based~     on individual requirements.~      The objective of this study is to assess the effect of the Personalized Dietary Advice~     Services (PDAS) after a three month intervention on established markers of nutritional and~     health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of~     the PDAS on perceived health status of diabetes type 2 patients will be assessed.~   "
51649|NCT02381106|"~     The primary overall objective of this study is to characterize the levels of and compare~     levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at~     different time points in pregnancy, in normal and dysfunctional labor and also to measure~     levels and expression of these receptors in placental arteries at different maturation~     statuses of placenta and in pre-eclampsia/hypertension~   "
51663|NCT02380924|"~     This is a randomized, single-blind, single-center, concurrently controlled, exploratory,~     Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50~     survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient~     volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to~     one of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).~   "
51650|NCT02381093|"~     The current method of teaching Basic Life Support (BLS) courses involves a practice schedule~     where learners rotate through each station once, without repetition. Laypeople learning~     within this blocked schedule may experience poor skill retention, resulting in suboptimal~     delivery of Cardiopulmonary Resuscitation (CPR). Implementing a Contextual Interference (CI)~     practice scheduling method to BLS training would involve presenting each station multiple~     times within the same timeframe. CI is known to lead to better retention in other domains,~     such as sport and engineering. Our project will test the effect of CI on the long-term~     retention of BLS skills. We hypothesize that participants trained in BLS using CI techniques~     will have superior skill retention at 3 months compared to those trained with the~     conventional BLS course.~   "
51651|NCT02381080|"~     The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A~     inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state~     pharmacokinetics (PK [the study of the way a drug enters and leaves the blood and tissues~     over time]) of repeated oral doses of ibrutinib in participants with B-cell malignancy~     (cancer or other progressively enlarging and spreading tumors).~   "
51652|NCT02381067|"~     The study is intended to demonstrate that the NuCel® allograft is effective and safe in~     promoting bone growth and fusion rate when used in cervical fusion in patients with one, two~     or three-level diseases of the cervical spine.~   "
51653|NCT02381054|"~     The purpose of this study is to see if the Italian language version of a questionnaire about~     symptoms that patients may have during cancer treatment is understandable to Italian~     speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed~     at the U.S. National Cancer Institute to help get information about patients' symptoms~     directly from the patients themselves. The Italian version of the questionnaire will be used~     in future studies to gain a better understanding of patient symptoms.~   "
51654|NCT02381041|"~     This study aims to compare two vasoconstrictive agents topically applied in cosmetic~     rhinoplasty: cocaine HCl 5% and adrenaline 1:1000. Blood loss during surgery as well as~     systemic effect of the studied agents are evaluated.~   "
51655|NCT02381028|"~     The aim of this small pilot study is to assess the potential effects and risks of applying~     fresh human milk locally on eczema spots in children with atopic eczema. This is a split~     body, controlled, randomized and physician blinded pilot study, of children with atopic~     eczema with two similar contralateral eczema spots having a mother breastfeeding the child~     or a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot~     and emollient alone on the control area, three times a day for four weeks. Severity and area~     of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed~     weekly with respect to bacterial colonisation.~   "
51656|NCT02381015|"~     This study was designed to compare the efficacy, perception, decision making, and~     cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate~     cancer and for chemoprevention of prostate cancer.~   "
51657|NCT02381002|"~     Background: Obesity is associated with alterations in iron metabolism leading to iron~     deficiency.~      Aim: to study the prevalence of obesity among primary school students, assess iron status~     among overweight/obese children with age ranging between 6 and 12 years and the effect of~     weight reduction program on iron status.~      Patients and Methods: The study will be conducted on 2 groups. Group 1 will include 1025~     primary school children recruited from 2 urban schools in Cairo with age ranging between 6~     and 12. Anthropometric measures and prevalence of overweight/obesity will be assessed. Group~     2 will include 100 obese children according to the CDC definition and 50 age and sex matched~     children with normal weight. All will be subjected to history taking, anthropometric~     measures, complete blood picture, iron profile and soluble transferrin receptor. Weight~     reduction program for 6 months will be done for obese children and all parameters will be~     re-ckecked.~   "
51658|NCT02380989|"~     Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common~     painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs~     (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.~      Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain~     extent. In practice, there are different treatment modalities for injuries, uses of drugs &~     dietetics as well as practices of rehabilitation. Although, previous evidences support the~     efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint~     swelling, mobility restriction and early morning joint stiffness. But there is no treatment~     studies have been performed to evaluate the clinical outcome for specific sports injuries.~      This study assessed the efficacy and safety of ayurveda gel and patches applied to the~     painful injury site for the treatment of acute minor sports injury pain.~   "
51659|NCT02380976|"~     A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative~     bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.~   "
51660|NCT02380963|"~     Dietary protein is a key element of most effective weight loss regimens. This study will~     investigate the effects of consuming soy protein on body composition and cardiometabolic~     health within the context of an effective weight loss and maintenance program called the~     Colorado Diet.~   "
51661|NCT02380950|"~     Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster~     resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol~     effects after gastric bypass we suggest that also general cognitive function is stronger~     impaired.~      Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8~     normal weight subjects) in the study. Each participant had to drink 250 ml white wine.~     Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions~     were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm.~     During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes~     with breathalyser Dräger Alcotest 7510.~   "
51662|NCT02380937|"~     The Radio Frequency Ablation for Atrial Flutter with Magnetic Resonance Guidance and~     Tracking Pilot Study (hereafter referred to as pilot study) is a prospective, non-~     randomized, single-center, pilot study. The purpose of this clinical study is to evaluate~     the safety and performance of the Imricor Medical Systems, Inc. (Imricor) Vision Ablation~     Catheter when used with related accessories for the treatment of type I atrial flutter. The~     Vision Ablation Catheter and its accessories have been designed for use under fluoroscopic~     or magnetic resonance guidance.~   "
51664|NCT02380911|"~     Hypercholesterolemia, a major cause of disease burden in both the developed and developing~     world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third~     of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the~     prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%,~     whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was~     37.3 % and the proportion of those who are under pharmacological treatment was dismally low:~     only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of~     coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on~     statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and~     low-dose aspirin were available free-of-charge at the primary care clinics of the public~     sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg)~     were incorporated into the package of drugs provided free-of-charge for patients with high~     cholesterol, according to CVD risk stratification. The goal of this study is to test whether~     a multifaceted educational intervention targeting physicians and pharmacist assistants,~     improves detection, treatment and control of hypercholesterolemia among uninsured patients~     with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will~     test whether a multifaceted educational intervention program lowers LDL-cholesterol levels~     and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance~     with clinical practice guidelines, and improves patient care management and adherence to~     medication. A cost-effectiveness study will be conducted to compare the intervention to the~     usual standard of care. This randomized cluster trial will enroll 350 patients from 10~     public primary care clinics who will be assigned to receive either the intervention or the~     usual care. This study is timely and will generate urgently needed data on effective and,~     practical and sustainable intervention programs aimed at the prevention and control of CVD~     risk that can be directly used in other primary care settings and health care systems in~     LMICs.~   "
51665|NCT02380898|"~     Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of~     intraoperative shoulder tip pain and improve discomfort during Caesarean section.~   "
51666|NCT02380885|"~     The study evaluates the effectiveness of the social cognition and interaction training~     (SCIT), in comparison to both therapeutic alliance focused therapy (TAFT) and treatment as~     usual (TAU) among persons with severe mental illness. Study purpose: 1) Assess the~     effectiveness of the SCIT and TAFT interventions, 2) Assess the processes that putatively~     contribute to the SCIT and TAFT outcomes. Method: A Randomized Controlled Trial (RCT) with~     approximately one hundred and fifty persons with severe mental illness will be carried out~     in different psychiatric rehabilitation units and clinics in Israel. To assess the relative~     effectiveness of the SCIT and TAFT interventions with persons with severe mental illness,~     both interventions will be compared to treatment as usual (TAU). Clinicians will be trained~     in both interventions, and outcome measures, including social quality of life and social~     functioning, as well as mediating processes, including the identification of affective~     states, ToM, attribution errors and therapeutic alliance, will be assessed. Cognitive~     functioning and symptom severity will be treated as covariates. Statistical analyses will~     include analysis of variance which takes into consideration attrition, effect size,~     mediation processes and covariates.~   "
51667|NCT02380872|"~     The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and~     -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival~     crevicular fluid during the early and late stages of healing for gingival recession sites~     treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus~     connective tissue graft. As PRF consists of several growth factors, it may enhance the~     healing potential of soft tissues, the investigators hypothesized that using PRF in the~     treatment of gingival recessions might regulate inflammation and promote wound healing.~   "
51668|NCT02380859|"~     Subjects diagnosed with Idiopathic Parkinson's Disease, between ages of 40-85 inclusive, who~     have been referred for gait training. Since there can be subtle differences in the brain~     organization of left- and right-handed people that may influence some of the measurements,~     right handed participants are preferred. However, a left handed participant may be~     considered. Participants will be randomly assigned to one of two groups to undergo two weeks~     of twice-daily sessions. Group A receiving goggles fitted with lenses that distort vision~     and Group B patients receiving sham goggles~   "
51669|NCT02380846|"~     This study aims to find out how consuming different proteins with rice affect metabolism.~     Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e.~     rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming~     different proteins with commonly eaten carbohydrates affect metabolism. Previous studies~     have shown that proteins stimulate hormones such as insulin, glucagon and gut hormones.~     However, the extent of the response depends on protein type. The metabolic responses to~     carbohydrates have also been shown to be greatly affected when they are eaten with proteins.~     However, most of the previous studies have used glucose as the carbohydrate and it is still~     unknown how eating proteins with carbohydrate foods such as rice affect metabolism.~     Therefore, this study has been initiated to determine the metabolic effects of eating~     different protein types with rice. Using the most common carbohydrate eaten in Asia (rice)~     and four commonly eaten protein foods (egg, chicken, fish and beancurd), this study aims to~     observe the metabolic effects of co-ingesting proteins and carbohydrate. The resulting data~     will provide valuable insights into the metabolic effects of protein-carbohydrate meals and~     will be useful in the development of practical advice and dietary guidelines for those with~     chronic diseases (such as diabetes and obesity).~   "
51670|NCT02380833|"~     The purpose of this study is to determine the effectiveness of recommending either a~     Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines~     with or without exercise on physical conditioning, hormones related to energy metabolism,~     body composition, resting energy expenditure, blood biomarkers, and urine in young, adult~     females.~   "
51671|NCT02380820|"~     The main objective of this study is to compare the Softform Premier mattress (in static~     mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.~   "
51672|NCT02380807|"~     This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in~     Patients with Fibromyalgia Syndrome.~   "
51685|NCT02380638|"~     The main aims of the present project include 1) to study the longitudinal effects of~     whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2)~     to evaluate whether a low frequency vibratory training program consisting of 3 sessions per~     week for 9 months (each vibratory session last approximately 10 minutes and includes 5-6~     bouts of 1 min with 1 min rest between bouts) can improve bone development in these~     populations. Finally, and additional aim of the project is 3) to determine how long these~     effects may last after the end of the intervention.~   "
51686|NCT02380625|"~     The purpose of this study is to determine whether multiple therapeutic regimens are~     effective in the treatment of Ebola Virus Disease (EVD)~   "
51673|NCT02380794|"~     Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant~     proportion of the population with an age-adjusted prevalence of approximately 12%.~     Claudication induced walking impairment can be debilitating and adversely affects social,~     leisure, and occupational activities in many patients and is associated with higher~     mortality among PAD patients.~      Unfortunately, very few effective therapies are available to improve leg symptoms and~     exercise performance in PAD patients. Surgery is the last resort but results vary.~     Therefore, there is a large unmet need for medical therapies that can improve long-term~     walking performance and functional capacity in PAD patients.~      Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of~     cardiovascular diseases. D&G study has been extensively researched and continued at The~     Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties,~     modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized~     trials were completed at the CUHK showing D&G improved lipid profile, vascular function and~     thinned down the internal layer of the carotid artery. One may expect the same with lower~     limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that~     D&G are well tolerated and safe.~      This project is a randomized control trial to determine the efficacy and Safety of D&G in~     improving the functional capacity & QoL in patients with symptomatic PAD. The results of~     this study have the potential to change local and international practice in providing a much~     needed therapeutic option in the treatment of PAD.~   "
51674|NCT02380781|"~     This is a prospective randomized control trial in which we propose an intervention in the~     immediate post-partum period to educate women about contraceptive options, particularly long~     acting reversible contraception (LARC) methods with an aim of increasing the amount of women~     who choose a LARC method.~   "
51675|NCT02380768|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA)~     Supreme.~   "
51676|NCT02380755|"~     Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy~     exists regarding if its a condition that needs to be treated. The standard Testosterone~     Therapy is associated with increase in cardiovascular risks, according to some studies, and~     leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as~     an alternative treatment option is not well studied. The aim of this protocol is to evaluate~     the cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized~     placebo trial.~   "
51677|NCT02380742|"~     The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce~     pain and discomfort at the time of vaginal pessary removal and insertion. Half of the~     participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will~     receive a placebo cream.~   "
51678|NCT02380729|"~     The MENDEL-study will investigate whether the use of gene panel or whole genome sequencing~     (WGS) will:~        1. improve the rate of diagnosis and through this compare the performance of the two~          diagnostic approaches (gene panel vs. WGS),~        2. investigate whether use of said sequencing approaches early in the diagnostic process~          results in reduced health care spending, and~        3. result in an improved quality of life for the patients and their parents.~   "
51679|NCT02379884|"~     This is a prospective observational study evaluating all patients requiring mechanical~     ventilation. Data will be gathered regarding the events prior to ventilation and the~     indication for mechanical ventilation. In-hospital and post-admission outcome will be~     monitored.~   "
51680|NCT02380703|"~     This study will evaluate whether a home-based targeted education and skill training~     (Agression Prevention Training or APT) will reduce aggression in persons with dementia (PWD)~     and pain/pain-related features more than usual care plus supportive telephone calls. Half of~     the participants will receive APT and half will receive supportive telephone calls.~   "
51681|NCT02380690|"~     To maximize implementation potential of pain self-management in the VA, alternative delivery~     methods are needed to provide Veterans with education and support needed to self-manage~     their pain, without requiring additional resources from healthcare teams. A novel and~     promising approach is a peer coaching model, in which Veterans with chronic pain who are~     successfully managing their pain offer information, support, and mentorship to other~     Veterans with pain.~   "
51682|NCT02380677|"~     A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until~     determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and~     then enrollment into Phase 2a expansion cohorts will be initiated.~   "
51683|NCT02380664|"~     Swimming training is associated with decreased bone mass and lower bone mass acquisition~     during growth periods, mainly when compared to other weight-bearing sports. Little~     information is available in adolescents pointing in the same direction but still~     controversial.~      On the other hand, bone strength do not only depends on bone mass but on bone structure and~     microarchitecture. The cross sectional area, cortex thickness or trabecular density are~     important aspects of bone health. There are few studies on the effect of swimming on bone~     architecture of adolescents. This information is relevant for present and future health of~     adolescents practicing swimming and for all the organizations promoting this sport. Jumping~     and whole body vibration training programs seem to elicit important osteogenic effects;~     however, there is little information on this regard in adolescent population, even less in~     these adolescents with potentially decreased bone acquisition such as swimmers.~      The main aims of this research project are therefore, to analyze the effect of swimming~     training on bone mass, metabolism, structure and architecture in adolescents analyzing~     possible relationships among them. Secondly, to test whether including short boots of~     jumping or whole body vibration may be able to palliate the possible deleterious effects of~     swimming and facilitate a normal or even healthier bone development. And finally to study~     the durability of training-related bone gains over time.~   "
51684|NCT02380651|"~     This study aims to assess the functional ability and health-related quality of life (HRQoL)~     of upper extremity sarcoma patients who have undergone limb salvage surgery.~   "
51751|NCT02379741|"~     The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal~     IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated~     injections directly into the tumor tissue) or intravenously (as repeated doses directly into~     a vein) in patients with advanced solid tumors.~   "
51687|NCT02380612|"~     This is a randomized, within-subject controlled study to compare the clinical performance of~     the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin~     grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1)~     confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a~     blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio~     of measured treated area to the measured donor site area, achieved for the ReCell-treated~     and control treatment areas. Safety will be evaluated in terms of long-term durability, scar~     outcomes and treatment-related adverse events.~   "
51688|NCT02380599|"~     Spinal mobilization and spinal manipulation are common techniques utilized in the field of~     physical therapy. Despite their common utility, little is known about the physiological~     mechanisms underlying the changes experienced following the interventions. Recent research~     suggests that neurological mechanisms may be involved in the post interventional changes,~     but research supporting this view is still evolving. Therefore, this study will explore~     whether there is a neurophysiological difference between spinal manipulation and spinal~     mobilization techniques. The neurophysiological difference will be measured by monitoring~     heart rate variability, a cardiovagal indicator of autonomic nervous system activity. The~     primary hypotheses of this study are three-fold, first that spinal manipulation will result~     in a change in heart rate variability that is different then sham intervention. Second,~     spinal mobilization will result in a change in heart rate variability that is different then~     sham intervention. Finally, the investigators hypothesize that spinal mobilization and~     spinal manipulation will produce different changes in heart rate variability.~   "
51689|NCT02380586|"~     A national survey of current practices, preferred drug and technique choices for obstetric~     anesthesia and analgesia in Czech Republic and Slovak Republic.~   "
51690|NCT02380573|"~     A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and~     12-week administration of USP methylene blue (MB) on cerebral blood flow, functional~     connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in~     healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.~   "
51691|NCT02380560|"~     100 women divided into 3 groups:~        -  Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50)~          with gestational age from 24 to 34 weeks.~        -  Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37~          to 41 weeks.~        -  Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age~          from 24 to 34 weeks.The myometrial thickness at 4 different sites9:~           a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary~          bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing~          the scan probe perpendicularly above the uterine fundus so that the entire curvature of~          the uterus was visualized.~           (d)The posterior wall: through using the maternal abdominal aortic pulsation as an~          anatomic marker.~      At least 3 measurements were obtained at each site and averaged. The latency interval is~     determined in each of the 3 groups.~   "
51692|NCT02380547|"~     Usefulness of non invasive ventilation in patients extubated after more than 48 hours of~     invasive ventilation is still in debate except for specific patients (chronic pulmonary~     disease and chronic heart failure).~      Many experimental and clinical studies have shown that diaphragmatic function is depressed~     by mechanical ventilation in intubated patients.~      The investigators will test the hypothesis that non invasive ventilation after extubation~     may improve diaphragmatic function~   "
51693|NCT02380534|"~     To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some~     inflammatory adypocytokines in patients with high cardiovascular risk.~   "
51694|NCT02380521|"~     The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in~     patients with type 2 diabetes mellitus (T2DM), which also seems to have some important~     non-glycemic effects. Yet, these non-glycemic effects are still largely unknown.~      The effect of exenatide once weekly was investigated in controlled, blinded and open-label~     clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in~     combination with oral antidiabetic agents, but also in multi-dose controlled studies and~     such studies resulted in significant reductions in glycemic parameters (mean glycated~     hemoglobin (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose~     levels), but also in body weight, over 24 to 30 weeks. Meaningful reductions were observed~     as early as week 4 of treatment, and maintained through 6 years of treatment.~      The study investigating cardiovascular effects of exenatide once weekly is currently~     undergoing. The results available are not numerous (such as DURATION-2, DURATION-3,~     DURATION-4 studies) and cannot lead to definitive conclusions.~      In this study the investigators will evaluate the effect of exenatide once-weekly on~     multiple cardiovascular risk markers. These markers are related to subclinical~     atherosclerosis, endothelial dysfunction, oxidative stress and atherogenic lipoproteins.~      The investigators will perform an open label, single-arm, prospective, intervention study~     using exenatide once weekly for a period of 8 months on 60 patients with T2DM.~   "
51695|NCT02380508|"~     TB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a~     better understanding of how the body's immune system reacts to BCG and in turn potentially~     prevents infection from other bacteria.~   "
51696|NCT02380495|"~     Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on~     Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio~     Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that~     contains all standardized tools (medical-healthcare web form, ACT, Asthma control test;~     PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for~     adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the~     registration to the web platform. Downloaded questionnaires will be delivered to~     case-patient, asking him/her to fill them during the waiting time of the visit.~   "
51734|NCT02379975|"~     Some clinical and epidemiological studies have revealed a high prevalence of periodontitis~     and tooth loss in patients with rheumatoid arthritis. The aim of this study was to evaluate~     the efficacy of periodontal scaling and oral hygiene instruction for patients with mild~     chronic periodontitis and rheumatoid arthritis through clinical periodontal parameters and~     laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).~   "
51697|NCT02380482|"~     Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and~     mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy~     to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a~     myocardial dysfunction might occur at the early phase of the traumatic brain injury. This~     myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In~     such case, improving myocardial dysfunction may help to increase cerebral blood flow and~     improve patient prognosis. In clinical practice the easiest and non invasive way to explore~     myocardial dysfunction is with transthoracic echocardiography. The objective of this trial~     is to investigate myocardial dysfunction at the early phase of traumatic brain injury,~     compared with a controlled group without TBI.~   "
51698|NCT02380469|"~     The purpose of this study is to investigate whether a systematic early assessment of~     uncovered needs for information, supplemented by an interview about the needs with the~     patient's nurse who seeks to provide the information requested, will improve the caregivers'~     and the patients' satisfaction with information and communication and potentially also~     decrease anxiety and depression.~   "
51699|NCT02380443|"~     This is a single center, open label dose frequency escalation study of InSituVax~     personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic~     lesion with intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer~     vaccine step combines killing a single metastatic tumor lesion by use of cryoablation in~     order to cause the release of tumor-specific markers to the immune system and then injecting~     bioengineered allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to~     modulate the immune response and educate the immune system to kill other tumor cells where~     ever they reside in the body.~   "
51700|NCT02380430|"~     In France, there are no precise data regarding perioperative organization of medical~     structure and care management of ambulatory surgical patients. Particularly, data on~     management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and~     treatment are needed, in several groups of patients.~   "
51701|NCT02380417|"~     This is a prospective observational trial of patient undergoing lung transplantation who~     have a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients~     pain scores and opioid use were evaluated for 7 days after placement as well as any~     complications, opioid adverse events, and length of stay.~   "
51702|NCT02380404|"~     1. Hypothesis/Specific aims~      The aim of the present study proposal is to validate an implant treatment concept in the~     edentulous upper maxilla using four implants-supported locators abutments to retain~     removable prosthesis.~      Specific aims:~        -  The primary objective of the study is to evaluate the implant and prosthodontics~          success rates of the proposed implant treatment approach after a follow-up period of 1,~          3 and 5 years as well as the biological and prosthodontics complications.~        -  The secondary objective is to assess the evolution of patient centered outcomes with~          the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL)~          and patients' satisfaction relating to their prostheses will be considered.~        -  The third objective will be to compare the implant, prosthodontics and patient-centered~          outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT)~          versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).~      Hypothesis:~        -  Implant survival rate using this treatment concept is similar to restoration with~          implant-supported fixed prosthesis, based on published data. No difference of implant~          survival rates is found between ANT and POST implant distribution.~        -  Prosthodontics survival rate using the following treatment concept is similar to the~          ones found with a bar, based on published data. The ANT implant distribution causes~          fewer prosthodontics complications compared to the POST implant distribution.~        -  There is a significant improvement in OHRQoL and patient satisfaction compared to the~          baseline OHRQoL observed with a conventional removable denture. The levels of~          improvement OHRQoL and patient satisfaction are similar for ANT and POST implant~          distributions.~   "
51703|NCT02380391|"~     Elevated on-treatment platelet reactivity is an independent risk factor of major adverse~     cardiovascular events following percutaneous coronary intervention or ACS. People living~     with HIV patients have a higher risk of recurrent events after ACS than people without HIV.~      The investigators hypothesized that this increased risk is driven by higher platelet~     reactivity.~      Using a nested case-control study design, HIV-infected and HIV-uninfected patients with a~     first episode of Acute Coronary Syndrome (ACS) treated with percutaneous coronary~     intervention were matched for age, sex, known diabetes mellitus and anti-platelet therapy.~      The primary end-point was the residual platelet reactivity (RPA) on dual antiplatelet~     therapy assessed by light transmission aggregometry (LTA, 20µM ADP).~      The study was conducted in a two large public university hospitals in central Paris, France.~   "
51704|NCT02380378|"~     This study was developed to document current diagnosis and treatment patterns, clinical~     outcomes, and health care resource use associated with Philadelphia-Negative~     Myeloproliferative Neoplasms, in the different risk classifications for each disease.~   "
51705|NCT02380365|"~     Experimental intervention: electrocardiography. Control intervention: none~      Duration of intervention per patient/subject:~      5 min, observation 6 months~      Key inclusion criteria:~        -  outpatients after lung transplantation (single, double or combined)~        -  outpatients on the wait list for lung transplantation~      Key exclusion criteria:~      • no informed consent~   "
51706|NCT02380352|"~     Randomized controlled double-blind non-inferiority clinical trial to determine whether five~     days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with~     10 days of high-dose amoxicillin for previously healthy children with mild~     community-acquired pneumonia.~   "
51707|NCT02380339|"~     Uncontrolled diabetes is associated with increased risk for micro-vascular complication.~     Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is~     associated with a range of unpleasant symptoms including palpitations, tremor, hunger,~     sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear~     of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH~     may increase behavioral attempts to avoid hypoglycemia including decreased consumption of~     insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control~     and an increased risk of diabetic complication. In this study, the investigators present a~     novel system, which simultaneously employs BioFeedback and Virtual Reality in order to cope~     with fear of hypoglycemia.~   "
51708|NCT02380326|"~     Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB),~     confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic~     path of pulmonary lesions in the non-oncological patient.~   "
51735|NCT02379962|"~     The purpose of this study is to collect date related to public knowledge and attitude~     towards biospecimen-based research and their willingness to participate in biobanking in~     China.~   "
51736|NCT02379949|"~     This randomized clinical trial compares virtual reality exposure therapy to exposure group~     therapy to a waiting list control group.~   "
51709|NCT02380313|"~     This study is being conducted to characterize the safety and recommended phase 2 dose (RP2D)~     of combining afuresertib, independently with 2 approved drugs: enzalutamide (Xtandi®,~     Xtandi is a trademark of Astellas Pharma, Inc. ) and abiraterone (Zygita®, Zytiga is a~     trademark of Janssen Biotech, Inc.). The study will be conducted in two parts. Part 1, a~     dose escalation phase, will establish RP2D of afuresertib when administered with~     enzalutamide or abiraterone. Part 2, a dose expansion phase, will further evaluate long-term~     safety of the combinations at the RP2Ds in additional subjects. Dose-finding cohorts will be~     studied in parallel and will evaluate safety and pharmacokinetic to guide selection of the~     dose regimens for further evaluation. Part 2 will begin once the RP2Ds have been established~     in Part 1. Additional doses and/or schedules may be explored if warranted, based upon the~     pharmacokinetic (PK) and pharmacodynamic (PD) assessments or emerging preclinical evidence.~     Overall, approximately 60 chemotherapy-naïve subjects with mCRPC and who are receiving~     either enzalutamide or abiraterone will be enrolled into the study.~   "
51710|NCT02380300|"~     The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance~     Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).~   "
51711|NCT02380287|"~     This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety,~     pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel~     monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male~     volunteers.~   "
51712|NCT02380274|"~     The purpose of this study is to describe patterns of care in CRPC patients, as well as~     health-related quality of life (HRQoL) outcomes associated with CRPC and its management.~      This study will also describe factors influencing treatment decisions including reason(s)~     for treatment choices and triggers for treatment changes for CRPC as well as describe~     clinical outcomes based on patient characteristics.~   "
51713|NCT02380261|"~     The purpose of this study is to verify the skin and ocular tolerance of the product Systane®~     Lid Wipes.~   "
51714|NCT02380248|"~     The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in~     dry eye subjects following 90 days of QID (4 times/day) dosing. This study will be conducted~     in India.~   "
51715|NCT02380235|"~     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)~     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of~     population of children.~   "
51716|NCT02380222|"~     The purpose of this study is to explore the key symptoms of individuals with systemic~     mastocytosis. Interviews of enrolled individuals will be conducted to learn about the~     disease symptoms and condition. The interview will last approximately 60 minutes and will be~     conducted by a trained interviewer, be audio-recorded (with patient consent), and all~     information provided by the patient will be treated confidentially and made anonymous so~     that it is non-identifiable. The interview may be conducted face-to-face, over the phone, or~     virtually via Skype, a free video conferencing program, depending upon the patient's~     geographic location. Patients will be compensated for their participating time.~      This is not a medication-related study, and no medication will be distributed or tested~     during this study. Participation in this study will not affect any treatment or assistance~     that a patient currently receives or may receive in the future.~   "
51717|NCT02380209|"~     Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer~     (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI~     scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.~   "
51718|NCT02380196|"~     The primary objective of this study is to determine whether circulating tumor cells (CTCs)~     can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage~     I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention~     will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to~     final pathologic diagnosis based on surgical specimens to assess the sensitivity of using~     CTCs alone to make a definitive diagnosis.~   "
51719|NCT02380183|"~     This is an openly randomized controlled parallel group study evaluating the effectiveness of~     using a guided approach and free-hand approach in performing upper extremity regional~     blocks. Potential subjects for this study are the patients who are scheduled for upper~     extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at~     Montefiore Medical Center.~      Rotating residents who are participating in the study will be randomly assigned either to~     perform block under guided approach (with the help of needle guidance) or free-hand without~     the needle guidance. All the blocks will be single injection blocks utilizing the in-plane~     technique for needle insertion which is the usual protocol in our institution. Each resident~     will be performing one interscalene block with the device and one without the device and one~     supraclavicular block with device and one without the device. An independent observer will~     be present during the case and will be responsible for recording the time taken to perform~     the block, number of times the needle has been redirected and the number of times the needle~     is reinserted. This observer will also administer the satisfaction questionnaire. Number of~     time needle is redirected and number of times reinserted is also a self reported assessment~     by the physician who is performing the block. Efficacy of the block will be assessed by the~     standard of care practiced at our center.~   "
51720|NCT02380170|"~     The study aims to get an insight on the causative bacteria of sepsis derived from the~     urinary tract. Furthermore, it is the intention to understand the outcomes of these~     patients. For this purpose a non-interventional, observational study will be conducted.~   "
51748|NCT02379780|"~     The investigators aimed to compare the effects of perioperative anesthesia consumption of~     ultrasound guided subcostal transversus abdominis plane and paravertebral block in~     laparoscopic cholecystectomy.~   "
51749|NCT02379767|"~     This study aims at evaluating the effect of electroconvulsive therapy in treatment-resistant~     depressed patients on the major serotonin degrading enzyme in the human brain using~     neuroimaging methods, the monoamine oxidase A. Electroconvulsive therapy is an effective~     treatment option in severe cases of depression. However, the mechanisms underlying its~     effect remain uncertain, though variations within the serotonergic neurotransmitter system~     seem to be crucially involved.~   "
51750|NCT02379754|"~     The purpose of the study is to determine whether vestibular and postural compensation~     following schwannoma surgery is improved by ablating remaining vestibular function prior to~     surgery, through gentamicin injections in the middle ear.~   "
51721|NCT02380157|"~     Project titel: Oral potassium supplementation in healthy men - interactions with the~     renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number:~     KARAASS-1 EudraCT number: 2013-004460-66~      Introduction The global burden of hypertension is huge. This project focuses on the role of~     potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure~     and some studies have shown an increase in blood pressure during potassium depletion. Thus~     an inverse correlation between potassium intake and blood pressure exists. In this trial the~     objective is to test how an oral potassium supplementation, administered in form of the drug~     Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic~     nervous system.~      Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A~     group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®,~     750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.~      On day 26 in the first treatment period the participants meet at the hospital to start a~     24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood~     sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done.~     The fat biopsy is expected to contain resistance vessels, which are to be investigated~     further in the laboratory.~      On day 28 in the first treatment period the participants meet at the hospital again and are~     tested with an intravenous Angiotensin II infusion followed by continuous measurement of~     blood pressure and the following aldosterone response (using blood samples). Blood pressure~     will be measured with Finger Plethysmography and vascular tonus will be evaluated with the~     use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of~     blood flow before, during and after the Angiotensin II infusion.~      After this first period of treatment and testing a washout period of two weeks is~     inserted. After washout, the participants crossover and starts the second treatment~     period.~      Feasibility All necessary authorities have approved the trial and all cooperation is~     established.~   "
51722|NCT02380144|"~     The study was designed as a randomized 2-way cross-over study to assess the bioavailability~     of carotenoids and flavonoids from sweet oranges and orange juice. Volunteers followed a~     wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange~     juice. The amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin~     (740 µg). After a consecutive wash-out period of 2 weeks, the procedure was repeated and the~     volunteers ingested the complementary test food. Blood samples were collected at 8 time~     points up to 9.5 h after test meal consumption. Additionally, 24 h-urine was collected to~     evaluate flavonoid recovery.~   "
51723|NCT02380131|"~     Stage I：preoperative therapy~        -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients~          with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage~          II: Perioperative therapy~        -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant~          Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2~          positive gastric cancer with liver metastasis;~   "
51724|NCT02380118|"~     The purpose of this study is to determine whether IM olanzapine is safer (fewer adverse~     events) and more effective (shorter time to sedation) than conventional haloperidol or~     midazolam when used in the management of acute agitation in the emergency.~   "
51725|NCT02380105|"~     This study aims to evaluate the effectiveness of counseling on pain, function and well-fare~     outcomes for the management of patients with temporomandibular disorder (TMD).~   "
51726|NCT02380092|"~     LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study~     serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™~     bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial~     insert).~      All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing~     surface and the results will be analysed against historical data from patients who received~     a Genesis II knee replacement.~   "
51727|NCT02380079|"~     The purpose of this study is to determine the safety and clinical effects of SCD-101 when~     given to adults with sickle cell disease. SCD-101 inhibits sickling of red blood cells~     containing Hb S (sickle hemoglobin) under low oxygen conditions, the underlying cause of~     sickle cell disease. SCD-101 may inhibit red blood cell sickling in patients with sickle~     cell disease and reduce symptoms and slow disease progression.~      This study will evaluate the safety and antisickling activity of SCD-101 in up to 24 adults~     with sickle cell disease.~   "
51728|NCT02380066|"~     The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in~     the Chinese Patients with Depression.~   "
51729|NCT02380053|"~     What are the differential effects of beta-blockers on lung and heart function during~     exercise in chronic obstructive pulmonary disease (COPD)? COPD is a major cause of illness~     and death. Not only do these individuals suffer from lung disease, but COPD often leads to~     other illnesses, particularly heart disease. Beta-blockers very successfully treat heart~     disease. It is therefore logical that one would want to use this treatment in COPD patients~     with heart disease too. However, there has always been concern that beta-blockers could~     cause significant problems in COPD by worsening lung function, as these can have the~     opposite effect to inhalers used to treat COPD that open up airways. Pointedly, there is~     increasing evidence that despite this problem, COPD patients who have been prescribed~     beta-blockers have been shown to gain benefit particularly in terms of preventing death.~      In this study, the investigators therefore want to examine which beta-blocker might be the~     safest for COPD patients, as each work slightly differently. Some beta-blockers may have a~     more beneficial effect on airways than others, whilst still benefitting the heart. The~     investigators will study two different beta-blockers; one that potentially narrows airways~     and one that potentially opens airways. The investigators will be using cardiopulmonary~     exercise testing (an exercise bike that measures both heart and lung function during~     exercise) to look for differences between both beta-blockers primarily in terms of lung~     function but also with information about the heart. The investigators will recruit people~     with moderate to severe COPD who are able to complete a cycle exercise test through their~     respiratory research department. The study will last for 10-12 weeks with 5 main visits to~     the department for serial exercise tests, breathing tests, simple heart function tests and~     simple blood tests that will tell the investigators what other effects these beta-blockers~     are having on the heart and lungs.~   "
51730|NCT02380040|"~     Photoplethismography will be measured and compared in newborns suffering from patent ductus~     arteriosus and normal controls.~   "
51731|NCT02380027|"~     This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy~     compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each~     participant will be randomly allocated to one of the biopsy tests.~      We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers~     than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS~     biopsy.~   "
51732|NCT02380001|"~     The purpose of the present investigation is to evaluate the effectiveness of the~     preoperative administration of Dexketoprofen Trometamol, employing the third molar surgery~     model, when compared to postoperative administration of the same drug. It was hypothesized~     that preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30%~     after 8 hours of the surgery, when compared with post-operative administration.~   "
51733|NCT02379988|"~     This is a pilot study to determine whether the addition of inspiratory hold (breath holding)~     can decrease the radiation dose that the heart and lung receive for patients being treated~     for left sided breast cancer.~   "
62586|NCT02238119|"~     Study to evaluate the lung function response to the free once-daily combination of~     tiotropium + formoterol compared to formoterol BID and tiotropium QD~   "
51737|NCT02379936|"~     The immediate newborn period is the period of highest morbidity in life. Early signs of~     serious disease are often vague and difficult to interpret for the non- specialist.~     Screening lists of clinical signs are useful but have unsatisfactory specificity or~     sensitivity, cover only one or two diseases, and are complicated to handle in low resource~     settings.~      In critically ill newborns, organ failure to one or multiple organ systems is frequently~     seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia~     ischemia of the cells in the affected organs followed by energy deficiency. Independently of~     the condition causing the energy deficiency this will start a series of events, which~     initially cause a leaking cell membrane leading to that intracellular components, i.e. the~     enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in~     newborns suggests that LDH is a clinically interesting early predictor of serious illness~     and may thus serve as an important complement to the clinical examination. If the LDH level~     is elevated the health care personnel will realize that something is wrong and call for~     appropriate measures.~      Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and~     accurate method. However, this method needs relatively large blood volumes and the delay~     between blood sampling and results is rather long, often several hours. In addition LDH is~     sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is~     detected at the laboratory a new sample will be needed, thus delaying the result even more.~     Also, smaller health care facilities rarely have the laboratory equipment needed for the~     analysis of LDH.~      The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH~     analysis called Hilda Neo. LDH is analyzed on an easy-to-use consumable test card together~     with an App on an ordinary smartphone (in the planned study, iPhone 4S). The result is~     presented within minutes and presence of hemolysis will be simultaneously detected on the~     device.~      The investigators speculate that the use of such a LDH test could serve as a diagnostic help~     for health-care staff in Vietnam in making the decision when to send a potentially sick~     newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)~   "
51738|NCT02379923|"~     The primary objective of this trial is to evaluate confirmation of placement of any~     guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in~     which at least one Asahi series of guidewires and/or Corsair microcatheter were used.~      Procedure success will be defined as angiographic visualization of any guidewire in a~     position either distal or proximal to the occlusion depending on the route of access and the~     absence of in-hospital MACE incorporating the MI Task Force Third Universal Definition of~     Myocardial Infarction.~   "
51739|NCT02379910|"~     This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of~     AM1030-CREAM in patients with Atopic Dermatitis.~   "
51740|NCT02379897|"~     Controversy exists about the role of dietary glycemic index (GI) and fat content and~     cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI,~     carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein~     (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index~     values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks,~     then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with~     calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight~     conditions, and in the free-living state for 48 weeks.~   "
51741|NCT02379871|"~     The topic of spinal manipulation (SM) has been a source of increasing research over the past~     decade. Research has focused primarily upon the functional and clinical outcomes associated~     with SM. The physiological mechanisms underlying the clinical changes experienced following~     SM are still largely unknown. Current thought suggests that SM may have an effect upon the~     neurophysiological system, specifically the autonomic nervous system. The purpose of this~     study will be to explore the effects of SM upon the autonomically regulated cardiovagal~     response.~   "
51742|NCT02379858|"~     The purpose of this study is to determine whether Alvimopan (Entereg) in ventral hernia~     surgery patients is associated with accelerated gastrointestinal recovery and reduced length~     of hospital stay compared to placebo controls.~   "
51743|NCT02379845|"~     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size~     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and~     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering~     surgery more feasible or easier and achieve better local control of the tumor.~      PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active~     controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the~     extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor~     injection, activated by external beam radiation therapy or external beam radiation therapy~     alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor~     surgery will be performed in all patients.~   "
51744|NCT02379832|"~     Preeclampsia may have several causes leading to different characteristics of the pathology.~     Differentiation between the type of preeclampsia would help to treat patients more~     accurately. This project aims to identify early markers that are specific to each type of~     preeclampsia (early or late, with or without growth restriction). Through a case-control~     study, many data will be collected prospectively (serum markers, ultrasonographic markers,~     maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first~     trimester) and nulliparous women with preeclampsia (at diagnosis).~   "
51745|NCT02379819|"~     This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24~     Implant in a group of newly implanted adults.~   "
51746|NCT02379806|"~     Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every~     year. Admission to hospital is one of the main risk factors for VTE, and could account for~     up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to~     reduce VTE global burden.~      The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight~     heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the~     latter accounting for the vast majority of events.~      Publication of these trials led to the implementation of thromboprophylaxis policies in~     hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis~     has been challenged after the publication of 1) a negative trial that used 'death from any~     cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the~     risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4)~     the last version of the American College of Chest Physicians Guidelines, focusing on~     symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical~     patients to a 1B recommendation, restricting its use to patients 'at increased risk of~     thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk~     of thrombosis, patients bleeding or at high risk of bleeding.~      However, a limitation of this interpretation of the data is that in most trials, patients~     with screened asymptomatic events were treated with anticoagulants, preventing the~     occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that~     elderly patients were at high risk of thrombosis in these trials, and that LMWH could be~     particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is~     also higher than in younger patients and the current trials were not powered to detect a~     difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic~     management of VTE is more challenging in the elderly. Therefore, we planned a randomized~     controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly~     patients.~   "
51747|NCT02379793|"~     The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and~     Liquid Paraffin in healthy Japanese male subjects.~   "
51752|NCT02379728|"~     Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low~     birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.~      Sleeping on the back during pregnancy has recently emerged in scientific literature as a~     potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate~     this link was conducted in Ghana by investigators on this protocol.~      When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of~     the major veins that delivers blood back to her heart and may completely obstruct it. This~     may result in less blood being returned to her heart and less blood being pumped to her~     developing fetus. Such changes may negatively impact the growth of her fetus and, along with~     some other risk factors, may contribute to the death of her baby.~      The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount~     of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple,~     safe, effective, and well-established modality called positional therapy.~      The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and~     assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their~     home setting via an antenatal care clinic and local health-care staff. Data from this study~     will be used in effect size calculations for the design of a large-scale, epidemiological~     study targeted at reducing LBW and SB in Ghana and globally.~   "
51753|NCT02379715|"~     Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence~     from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia~     (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to~     adult or children, so there were many studies about reducing the airway reflex combined with~     desflurane.~      Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in~     the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for~     reducing airway reflex or cardiovascular response for intubation combined with desflurane.~     But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this~     point could be a limitation because desflurane concentration over 1 MAC increase airway~     irritation significantly. This study this study was designed to determine a median effective~     effect-site concentration (EC50) of remifentanil to prevent airway irritation during~     desflurane anesthesia over 1 MAC.~   "
51754|NCT02379702|"~     Following the first study conducted to investigate the prevalence of metabolic syndrome and~     its components in Turkey, it was aimed to demonstrate the change in general health condition~     of available patients after the period of time lapsed. This study will provide important~     information on the social and economic dimensions of metabolic syndrome and will contribute~     to development of preventive programs.~   "
51755|NCT02379689|"~     Dr. Parker (the Investigator) and Semmes Murphey Foundation (Foundation) are conducting~     a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic,~     P.C. (Semmes-Murphey). This study will look at a product that is derived from human~     tissue, that will be injected into the affected disc. With this study, the investigators~     hope to find a safe and effective way to treat degenerative disc disease.~   "
51756|NCT02379676|"~     The purpose of this study is to compare the effects of ticagrelor and clopidogrel on~     endothelial dysfunction and vascular inflammation~      Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with~     clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary~     intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month~     after the index event. Ticagrelor treatment will improve percent flow-mediated dilation~     (FMD) values and reduces inflammatory gene expression on peripheral blood mononuclear cells.~   "
51757|NCT02379663|"~     This prospective study compares an oral direct factor Xa inhibitor with LMWH for~     thromboprophylaxis in the patients undergoing THA.~   "
51758|NCT02379650|"~     Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most~     cases of RPL are unexplained and have no effective treatment to improve the likelihood of a~     pregnancy resulting in a live birth. This leads to significant patient and provider~     frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in~     pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus~     erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has~     anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in~     couples with unexplained RPL. Although some providers are already prescribing HCQ for~     unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy~     and safety of this treatment. This study has the potential to establish support for a new~     treatment option for unexplained RPL.~   "
51759|NCT02379637|"~     This study is designed to improve knowledge regarding the initial effectiveness of~     N-acetylcysteine (NAC) on cold and cough symptoms.~   "
51760|NCT02379624|"~     Acute lower gastrointestinal dysfunction is a kind of much common complication which~     occurred in critically ill patients. Once it developed, enteral nutrition would be~     disturbed. In this study, investigators suppose that early application of a sufficient~     amount of pectin ahead of enteral nutrition, may promote recovery of acute lower~     gastrointestinal dysfunction in critically ill patients, and exert its good effect on early~     EN support.~      Investigators designed this prospective randomized controlled trial to test and evaluates~     the effect whether EN feeding with or without a pectin start would be safe or with advanced~     clinical outcomes.~   "
51761|NCT02379611|"~     Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear~     implanted profound congenital deaf infant would be different to the development of a~     normally hearing infant.~      At 24 months of age, the neurologic development of TVA of deaf infant implanted before the~     age of 18 months would be similar to the development of a normally hearing infant.~      Main aim The main aim of the research is to study, by means of functional near infrared~     spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1~     month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound~     congenital deaf children implanted before the age of 18 months.~      Main outcome Measure and localization of an increase of brain blood flow during an auditory~     stimulation voice type compared to a stimulation non-voice type. Comparison of the~     results between groups at 24 months of age +/- 1 month allows to analyse eventual~     differences.~      Secondary aims and outcomes To study by means of functional near infrared spectroscopy the~     neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a~     group of normally hearing infant and in a group of profound congenital deaf infant wearing a~     standard hearing device between the age of 11 and 13 months and who will receive a cochlear~     implant between 12 and 18 months of age.~      To study the association between fNIRS data and clinical data of the evaluation of~     comprehension of the spoken language at 24 months of age.~      Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months~     old children will be included during a medical consultation in the ENT department of Necker~     hospital after complete information of both parents. Written consent of both parents will be~     required. An audiophonological checking will be done.~      Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital~     and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). This fNIRS~     examination measures the modifications in brain blood flow during the listening of human~     voice sound and environmental sound.~   "
51762|NCT02379598|"~     Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In~     industrialized countries there is an incidence of 2-3% in children younger than 2 years.~     Cow's milk allergy may present with different clinical pictures and symptoms often~     nonspecific. Among the most common are certainly food refusal and failure to thrive until~     frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a~     negative impact on the quality of life of the patient and his family.~      The treatment of this condition provides the setting of a diet that is free of the allergen~     to the base of the adverse reaction.~      There are some types of formulas for the treatment of this condition. The formulas based on~     amino acids are currently used in all cases non-responsive to treatment with the above~     formulas or in all those characterized by severe allergic reactions. Being made from amino~     acids such formulas are by definition non-allergenic. They have also proven to ensure a~     rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as~     lead to a rapid improvement in the quality of life of the patient and his family. However,~     the studies currently available to us concerning the effects of nutritional formulas based~     on amino acids affect short observation periods (usually less than 6 months) and were~     directed to a comparison only with hydrolysates of whey protein or casein and not with~     healthy subjects. To date thus lack consistent data on the nutritional effects in the medium~     to long term.~   "
51763|NCT02379585|"~     This study is to see how safe the use of short-term fasting is in breast cancer patients who~     will receive chemotherapy before undergoing surgery and to examine if the use of short-term~     fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while~     receiving chemotherapy.~   "
51764|NCT02379572|"~     Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by~     concomitant chemoradiation. The extent of resection is one of the most important prognostic~     factors with significant influence on the survival of patients. State of the art technique~     to achieve the most radical resection possible in conventional surgery is~     fluorescence-guidance with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI~     (iMRI)-guided tumor resection enables an intraoperative resection control and subsequent~     continuation of surgery if contrast enhancing tumor remnants are found. Therefore a more~     radical resection and longer survival of patients might be possible. To date no comparison~     of these two leading technologies for GBM-surgery is available to identify the best surgical~     therapy of this fatal disease and to justify significant healthcare-economic differences~     between both technologies.~      Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in~     comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total~     resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48~     hours after surgery) in each group. Secondary endpoints are perioperative clinical data,~     progression free survival, patients' clinical condition and overall survival.~      The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA~     centers (n=13) to exclude possible bias which might be found by randomizing patients within~     individual iMRI centers and to have surgeons with the most experience possible in use of~     each respective technology.~   "
51765|NCT02379559|"~     The main purpose of this study is to examine the feasibility of an exercise intervention on~     metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men~     with MetS who are at increased risk of prostate cancer.~   "
51766|NCT02379546|"~     This study was designed to determine the effect of the depth of anesthesia on the~     oculocardiac reflex (OCR) during pediatric strabismus surgery.~   "
51767|NCT02379533|"~     Patients will be randomly assigned to perform the training program in center or home-based .~     The training program will be conducted in accordance with the recommendations of the~     American College of Sports Medicine. All training sessions will be preceded by stretching of~     large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5~     minutes). The program will consist of 24 weeks with three sessions per week on alternate~     days. The aerobic training will be continuous, with an increment of 10 minutes in duration~     every 4 weeks. The intensity will be prescribed according to ventilatory threshold,~     characterized by the highest intensity of physical exertion fully maintained by aerobic~     energy pathways. The intensity control was done by means of the heart rate value obtained at~     ventilatory threshold.~      Both groups receive the same intervention. However, a group exercise held in the center on a~     treadmill with the direct supervision of a physical education teacher. The other group will~     exercise at home with telephone follow-up weekly and once a month will be held at the~     training center under the supervision of a physical education teacher.~      It will also constituted a control group remain without performing any activity during the~     study period. After 24 weeks patients receive the same advice the team conducting the~     training at home.~   "
51768|NCT02379520|"~     Subjects have a type of cancer that has been associated with an infection with a virus~     called human papilloma virus (HPV). The cancer has come back, has not gone away after~     standard treatment or the subject cannot receive standard treatment.~      This is a research study using special immune system cells called HPVST cells, a new~     experimental treatment.~      Investigators want to find out if they can use this type of treatment in patients with~     HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from~     the blood of patients with HPV-cancers. They want to see if these special white blood cells,~     called HPVST cells, that will have been trained to kill HPV infected cells can survive in~     the blood and affect the tumor. They will also see if they can make the T cells more active~     against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that~     these HPV-cancers produce. They will grow these HPVST cells from the patient's blood.~      The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how~     long they last in the body, to learn what the side effects are and to see if the HPVSTs will~     help people with HPV associated cancers.~      If the treatment with HPVST cells alone proves safe (Group A), additional group of patients~     (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment.~     Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved~     for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion~     will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby~     giving them room to expand. The purpose of this part of the study is to find out if TGF-beta~     resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body~     and if they are more effective than HPVST cells alone in controlling the tumor.~   "
51769|NCT02379507|"~     This open-label, adaptive design study was designed to determine the efficacy of the study~     product in the treatment of eczema which would be assessed by the reduction of the~     appearance of skin lesions and symptoms associated such as itching, scaling and redness.~   "
51770|NCT02379494|"~     To evaluate the feasibility of screening for preeclampsia and fetal growth restriction~     between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler,~     maternal blood pressure, maternal characteristics, placental volume, and maternal serum~     factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.~   "
51773|NCT02379455|"~     Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related~     problems, and several studies indicate that inappropriate drug use is a major reason for~     poor health and impaired function in the elderly. A majority of interventions for~     improvement of drug treatment in the elderly have been evaluated by the use of surrogate~     outcomes such as drug-related problems, number of prescribed drugs or prevalence of~     potentially inappropriate prescriptions - and it is so far unclear whether such~     interventions can result in clinical significant improvements. The primary objective of this~     trial is therefore to evaluate the effect upon patients, relatives and local health care~     service of a structured cooperation between a hospital-based geriatrician and family~     physicians on complex drug regimens in home-dwelling frail elderly patients.~   "
51774|NCT02379442|"~     Background:~      - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and~     cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want~     to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can~     travel in the body and help repair tissue. The BMSC in this study were grown from bone~     marrow from healthy volunteers.~      Objectives:~      - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body~     s immune system responds to BMSC.~      Eligibility:~      - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD.~     People who have had certain previous immunosuppressive therapy may be ineligible.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~          They will have a GVHD exam, including skin and stool tests. They must have a~          functioning central line.~        -  Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the~          rest of the weeks.~        -  Up to 12 cell infusions:~        -  Participants will come to the clinic twice weekly.~        -  They will get medicine to prevent side effects (like Tylenol and Benadryl).~        -  BMSC will be given through a small plastic tube in an arm vein or through an IV~          catheter. It will last 20 60 minutes.~        -  Participants will be monitored for 1 hour.~        -  Follow-up visits: Up to twice a week, participants will have physical exam and blood~          tests. They may have a GVHD exam.~        -  Participants who have a tissue biopsy outside the study will be asked to send a sample~          to the study.~   "
51775|NCT02379429|"~     Background:~      Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better~     understand what changes in a person s cells and genes cause this cancer to form. This may~     help them find new ways to treat it.~      Objective:~      - To perform DNA sequencing to help researchers learn the differences between normal tissue~     and tumor tissue. Also, to learn how molecular changes - including gene changes - might help~     predict the course of disease and how people respond to therapy.~      Eligibility:~      - Adults age 18 and older who have or are suspected of having urothelial cancer or an~     inherited disorder that raises their risk of getting bladder cancer.~      Design:~        -  Participants will be screened with a physical exam. Their medical records and tissue~          samples will be reviewed.~        -  Eligible participants will give tissue blocks of their original tumor. The blocks will~          be put in a tissue bank.~        -  Participants medical records may be reviewed.~        -  Participants may have a medical history and physical exam.~        -  Participants may have blood and urine tests. They may have imaging scans. They may give~          urine, blood, and saliva samples. These samples may be used in future research.~        -  If participants need surgery for their cancer, researchers will keep some of the tissue~          (both tumor and normal tissue). The tissue may be used in future research.~        -  Participants will go back to the Clinical Center in 6 months. They may give saliva,~          urine, and blood samples. After 6 months, they will be seen by their local doctor for~          standard post-surgical visits.~        -  Participants will be called every 6 months to give health updates.~   "
51776|NCT02379416|"~     Background:~      - Researchers want to find better ways to treat cancer. One drug that treats cancer is~     paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if~     another drug, nilotinib, helps paclitaxel work better.~      Objective:~      - To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can~     be given safely to people.~      Eligibility:~      - Adults at least 18 years old with advanced cancer that has progressed after receiving~     standard treatment, or for which no effective therapy exists.~      Design:~        -  Participants will be screened with tests they usually get in their cancer care: medical~          history, physical exam, blood and urine tests, heart test, and scans.~        -  Participants will take the two study drugs in 28-day cycles. They will keep a medicine~          diary.~        -  Nilotinib will be taken by mouth twice every day except day 1 of the first cycle.~        -  Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will~          usually be done at the clinic.~        -  Most participants will have a weekly study visit every week for cycle 1, then the first~          3 weeks of other cycles. They will have:~        -  Physical exam at every visit.~        -  Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles.~        -  Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or~          they may be ultrasounds, where a wand is pressed on the skin with gel on it.~        -  Around 30 days after stopping the study drugs, participants will be called to discuss~          any side effects.~   "
51785|NCT02379299|"~     The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully~     automated system for intensive insulin treatment. Such system will ease the burden of~     constant treatment decision-making and at the same time it has the potential to safely~     intensify insulin therapy such that more patients can reach treatment goals. Currently, no~     off-the-shelf closed-loop system exists but research efforts in this field have been~     intensified and resulted in great progress in recent years. Most closed-loop systems consist~     of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that~     continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For~     daytime blood glucose control, however, we believe that the system needs to be further~     advanced. Consequently, we have extended our single-hormone closed-loop system such that it~     now includes a second pump for glucagon delivery and correspondingly we have further~     developed our control algorithm to compute both insulin and glucagon dosages.~      We hypothesize that we have developed a safe and effective dual-hormone closed-loop system~     for patients with type 1 diabetes and that this system is superior to single-hormone~     closed-loop therapy. The aims of this two-phase project are to 1) demonstrate~     proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose~     control.~   "
51777|NCT02379403|"~     Background:~      - Heart disease is the leading cause of death and disabilities in the United States. Diets~     high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red~     tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to~     know how tart cherry and aroniaberry extracts affect heart health.~      Objective:~      - To study the benefits of tart cherry and aroniaberry extract on vascular function and~     other measures. These include inflammation, oxidation, and cholesterol.~      Eligibility:~      - Men and post-menopausal women ages 55 70 in good health and with normal or slightly high~     blood pressure or cholesterol.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  Participants will have 6 visits. They will have blood taken at every visit.~        -  Visit 1:~        -  Blood vessel tests. Participants will lie down. Heart rhythm will be monitored. A~          device will be placed on the upper arm, and pictures of blood vessels will be taken.~        -  A blood pressure cuff will be tightened around the lower arm for 5 minutes.~        -  Cardio-Ankle-Vascular Index (CAVI). Blood pressure cuffs will be placed on both arms~          and legs. They will be tightened with air at the same time for a few minutes.~        -  Participants will be assigned to one of three groups. For 3 weeks each, in random~          order, they will take: aroniaberry capsules, tart cherry capsules, placebo capsules,~          and no capsules.~        -  Participants will answer questions online about their eating and exercise.~        -  Participants will be keep a record of what they eat for a few periods. They will come~          for a study visit every 3 weeks through week 15.~   "
51778|NCT02379390|"~     Primary Objective:~      To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of~     cabazitaxel versus either enzalutamide or abiraterone plus prednisone in patients with~     metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while~     receiving AR targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months~     of treatment initiation (≤12 months).~      Secondary Objective:~        -  To compare efficacy for:~        -  Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).~        -  Progression Free Survival (PFS).~        -  Overall Survival (OS).~        -  Tumor response rate and duration of tumor response.~        -  Pain response and time to pain progression.~        -  Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.~        -  To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice~          variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).~        -  To evaluate safety in the 2 treatment arms.~   "
51779|NCT02379377|"~     This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)~     positron emission tomography (PET) in imaging patients with liver cancer before undergoing~     surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and~     diagnose liver cancer and find out how far the disease has spread.~   "
51780|NCT02379364|"~     The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis~     technique on pain, range of motion (Patellofemoral joint mobility test and muscle length~     test), strength and function in patients with Patellofemoral Pain Syndrome and muscle~     shortening.~      Muscle imbalance is one of most important factor associated with Patellofemoral Pain~     Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella~     position and tracking and patellofemoral pain. The scientific evidence for effectiveness of~     any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.~      Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences~     and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is~     applied by a set of metallic hooks having the advantage of allowing a deeper and more~     precise application, which could not be achieved manually.~      The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied~     in the soft tissues more related with patellofemoral pain.~   "
51781|NCT02379351|"~     Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These~     tests are currently conducted in clinics and hospitals. This requires travel to a clinic or~     hospital, sometimes multiple times per week, in order to receive these tests. Technology has~     been developed that now allows for NSTs to be done in other locations, including home or~     work. The Airstrip® Sense4Baby™ NST device has been FDA-approved for use by obstetricians in~     clinical and hospital settings. The investigators are evaluating the use of the Airstrip®~     Sense4Baby™ NST device in out-of-hospital settings. The investigators would like to know if~     this type of monitoring is feasible and acceptable to patients and physicians.~   "
51782|NCT02379338|"~     In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to~     determine the biodistribution, metabolism and excretion of a novel radiotracer~     [18F]Fluortriopride ([18F]FTP).~   "
51783|NCT02379325|"~     Smoking cessation is a priority for preventing smoking-attributable disease and reducing its~     burden. Quitting smoking at any age confers substantial and immediate health benefits,~     including reduced risks of stroke, cardiovascular disease and smoking-related cancers, and~     quitting smoking by the age of 30 reduces the risk of dying from tobacco-related diseases by~     almost 90%. The World Bank suggests that if adult cigarette consumption were to decrease by~     half in the year 2020, approximately 180 million tobacco-attributable deaths could be~     avoided. Therefore, promotion of smoking cessation has been proposed as a primary focus of~     tobacco control efforts, especially in developing countries where smoking prevalence and~     cigarette consumption are both still relatively high~   "
51784|NCT02379312|"~     To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very~     low energy aerated beverage with normal energy aerated beverages in healthy subjects.~   "
51786|NCT02379286|"~     The main objective is to assess the relationships between French teenagers' attitudes and~     beliefs towards alcohol and tobacco products and the degree to which they watch and relate~     to television series and music videos.~   "
51787|NCT02379273|"~     This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid~     L24 Implant System in a group of already implanted recipients.~   "
51837|NCT02378623|"~     Patients with a patent foramen ovale in the setting of endocardially placed cardiac~     implantable electronic devices such as pacemakers, defibrillators, or resynchronization~     therapies are likely at higher risk for paradoxical embolic events from device lead~     thrombus. The investigators are conducting this study to determine if the anticoagulant~     medication Apixaban is more effective at reducing MRI detected brain lesions compared to~     placebo.~   "
51788|NCT02379260|"~     The aim is to built a Therapeutic Education Program for patients treated with radical~     prostatectomy in order to improve their sexuality.~      This study is carried out in two steps :~        -  Identification of specific educational objectives through a sociological study, with~          interviews and focus groups conducted and analyzed by a sociologist. Patients from the~          urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL)~          will be included~        -  Development of the program by a caregiver education expert (Centre Hygée), adapted~          partly from results of the qualitative study and partly from concepts and tools from~          the Education Sciences.~   "
51789|NCT02379247|"~     Investigate the use of BYL719 as combination therapy with Nab-Paclitaxel in locally~     recurrent or metastatic HER-2 negative breast cancer.~   "
51790|NCT02379234|"~     Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy~     in intensive care units for patients with acute renal failure. In theory, this therapy~     should be continuous, 24 hours/day.~      However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled,~     with frequent circuit down-times (between 1 to 6 hours/day). There are many reasons for~     premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low~     anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the~     CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions,~     particularly in case of alarms.~      High-fidelity simulation has been recently proposed for health care provider education. It~     has been consistently associated with large effects for outcomes of knowledge, skills, and~     behaviors but with moderate effects for patient related outcomes. Indeed, few studies have~     assess the impact of simulation on patient outcome following complexe procedures, that~     implies team work in addition to individual skills.~      In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in~     addition to the dialysis that we already used). Before implementing this new technic in the~     ICU, investigators designed this study in order assess wether a high-fidelity based~     ICU-nurses education program would improve the outcome of CVVH sessions, compared to the~     conventional education program, proposed by the CVVH manufacturer.~   "
51791|NCT02379221|"~     The purpose of the study is to compare two modalities of local anesthetic administration~     prior to the placement of cosmetic facial injectable fillers. Both short and long term pain~     perceptions for the facial filler procedure will be compared in patients receiving 4%~     Topicaine gel on half their face and 2% lidocaine 1:100k epinephrine nerve block injections~     on the other half of their face. The objective is to quantify the subjective pain~     experienced by these two modalities of local anesthetic during the procedure of Juvederm XC~     filler injections.~   "
51792|NCT02379208|"~     The purpose of this study is to evaluate rate of progression in newly diagnosed open angle~     glaucoma with different types of perimetry. Would it be possible to find the rapidly~     progressing individuals sooner by doing perimetry more often? Is there a difference between~     different types of perimetry in early glaucoma? What would be the optimal timing of~     perimetry in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients~     will be evaluated with two types of questionnaires in three different time points. The~     enrolled patients will receive appropriate treatment according to glaucoma management~     guidelines.~   "
51793|NCT02379195|"~     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive~     clinical results with durable complete responses in patients with metastatic melanoma. The~     TILs are isolated from the patients own tumor tissue followed by in vitro expansion and~     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of~     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion~     Interleukin-2 are administered to support T cell activation and proliferation in vivo.~      In this trial the therapy is combined with peginterferon (the pegylated form of interferon~     alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA~     expression on melanoma cells and are hypothesized to synergize with TIL therapy.~   "
51794|NCT02379182|"~     Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients~     admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion~     and exclusion criteria will be consented into the clinical investigation. Patients who meet~     the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to~     either active (motor or sensory) or standard treatment (control group) arms.~      Subjects included in this clinical investigation will be evaluated at screening, 1-week,~     3-months and at 12-months post treatment.~      The main aim of the study will be to assess the effect of VitalStim therapy on improving the~     safety of swallow according to the VFS, after the treatment and at 1-year follow up, on~     patients with chronic post-stroke OD.~   "
51795|NCT02379169|"~     Low macular pigment optical density has been associated with increased risk of age-related~     macular degeneration, an important cause of vision problems in the elderly population. Dry~     eye is multifactorial disease of tears and the ocular surface associated with symptoms of~     dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age.~     The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye~     health, specifically on the macula.~   "
51796|NCT02379156|"~     The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons~     with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability~     of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia~     to impair mental function in able-bodied (AB) persons, there has been no work to date~     addressing these issues in persons with tetraplegia.~      Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes~     Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a~     decrease in cognitive function.~      Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of~     the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with~     tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop~     Interference scores (a measure of executive function).~      Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate,~     and (3) thermal sensitivity.~      Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average~     distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings~     compared with AB controls.~      Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine~     (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the~     decline in cognitive performance in the group with tetraplegia compared to the exact same~     procedures performed on the day with no medicine (Visit 1) in that same group.~      Tertiary Hypothesis: Through administering a one-time dose of midodrine, the~     medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and~     prevent or delay the associated decline in cognitive performance compared to the changes in~     Tcore and cognitive performance during cool temperature exposure without midodrine in the~     same group with tetraplegia.~   "
51835|NCT02378649|"~     A randomized, placebo controlled, single center clinical trial for evaluation of efficacy~     and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV)~     Surgery in patients with pre-operative Significant Pulmonary Hypertension.~   "
51797|NCT02379143|"~     Various national & international bodies like FDA, CSP has laid down the guidelines for the~     reasonable use of SWD electro therapeutic agent (EPA) ensuring safety & effectiveness.~      However, it remains uncertain, whether the practicing physiotherapists are aware of the very~     existence of this guidelines and implementing them in daily practice. Any lack of knowledge~     about this background can endanger the patient safety leading to serious health hazards.~      In the present survey, 49 physiotherapy practitioners were interviewed with a self-report~     measure to investigate their knowledge base, mode of application of SWD (6 items) & the~     awareness about recommended guidelines (5 items) etc.~   "
51798|NCT02379130|"~     The purpose of this study is to determine the effects of Family Nurture Intervention in~     preschool aged children between 2.5 and 4.5 years of age who were born prematurely and~     exhibit developmental deficits. The new approach is based on improving aspects of maternal~     nurturing behaviors as well as mother-child co-regulation, which are important to early~     development. Since young children with developmental deficits are often easily upset,~     mothers will be taught how to co-regulate with their child through comfort and calming~     interactions during 11 clinic visits. Assessments in the follow-up clinic will test the~     immediate and long-term effects of this new approach to the nurture of children who were~     born early and demonstrate developmental problems and behavioral problems.~   "
51799|NCT02379117|"~     Food intake is mainly controlled through interactions between the gut and brain (the~     homeostatic control) and through our environment, with food exposure, mood and past~     experiences (the hedonic control) playing a major role. The link between the gut and the~     brain is mainly controlled through enteroendocrine cells (EC). These cells in the bowel~     sense nutrients in the food and link with the brain to control how much we eat. They make a~     number of hormones that link with the brain to control one's eating habits.~      Crohn's disease (CD) is an inflammatory disease of the bowel which can present with a number~     of symptoms including weight loss and loss of appetite. We thought some time ago that an~     increase in the number and function of these EC could play a central role. Since then we~     have carried out work which has shown that in CD these EC increase in number and produce~     more hormones after a meal. This finding could have a negative effect on food intake. This~     would be one explanation to the symptoms so commonly experienced by these patients.~      In CD we thus feel that there might be an imbalance in the appetite control. We expect an~     increasingly sensitive gut to food intake and a subdued mood and perception to food reward~     and that this imbalance will lead to a decrease in food reward and consequently a decrease~     in food intake.~      This study will be carried out using Healthy Volunteers and CD patients. We plan to measure~     food intake though telephone interviews and plan to analyse eating behaviour through 5~     questionnaires.This study will help us to improve our understanding of what it is that~     controls food intake. This will be particularly important to patients with CD who routinely~     lose weight and appetite.~   "
51800|NCT02379104|"~     ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is~     fully automated allowing for a simple and safe operation compared to its predecessor model~     ROTEM® delta.~      Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of~     equality.~      Confirmation of reference intervals of the ROTEM® systems.~   "
51801|NCT02379091|"~     The purpose of this study is to establish proof of concept and identify the optimal~     efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate~     (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor~     (TNF)-inhibitor (TNF-IR).~   "
51802|NCT02379078|"~     Diabetes care is complicated for people with diabetes as well as for health care providers:~     they have to watch their diet, exercise, take medications, checking blood sugars and blood~     pressure, get tests and see multiple doctors. On top of that, many with diabetes have other~     health problems, such as high blood pressure or arthritis, that make care even more~     complicated. Guidelines for improving the care of people with diabetes try to help by~     summarizing the best practices for care, but because diabetes care is so complicated, it is~     hard for them to be put into practice. One solution to this is a tool that can help people~     with diabetes set health care goals that are important to them, and participate actively in~     decisions about their own health care, together with health care providers. This tool would~     have an information booklet for patients with facts that can help them make a decision, a~     worksheet to help spell out what their goals are and how they want to get there, and a~     cheat-sheet for health care providers that gives them tips on how to do this. The purpose of~     this project is to find out if a tool like this would be helpful, how to make it more~     helpful and usable, and what the best way would be to make sure that people use it.~      An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including~     a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be~     implemented successfully in clinical practice and will reduce decisional conflict and~     diabetes distress and improve chronic care delivery and quality of life in patients with~     type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators~     hypothesize that patients in the intervention arm of the study will have reduced decisional~     conflict and diabetes distress, and improved decision-making satisfaction, chronic care~     delivery and quality of life.~   "
51803|NCT02379065|"~     The investigators are looking at whether a new type of nebuliser (a machine used to deliver~     drugs to the airways) is better at delivering drugs to the lungs of people with Chronic~     Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency~     Departments. The investigators will randomly allocate patients who come into the Emergency~     Department with an acute episode of the COPD into either the standard nebuliser group or the~     new nebuliser group.~      Both groups will receive the same medications, it is only the method of delivering them~     which will be different.~   "
51804|NCT02379052|"~     The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous~     (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with~     active, moderate to severe eosinophilic esophagitis (EoE). The study comprises 2 sections~     with double-blinded, randomized, placebo-controlled study and an open label extension (OLE)~     to evaluate long-term safety.~   "
51805|NCT02379039|"~     The study's aim is to define imaging and molecular bio-markers for prediction of~     radiotherapy response of squamous cell carcinomas, in an early treatment phase.~   "
51806|NCT02379026|"~     This study evaluates the addition of a high-protein energy-restricted diet to exercise in~     the treatment of sarcopenic obesity in people aged 65 and over. Half of participants will~     follow a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight)~     diet alongside an exercise regime, while the other half will follow the same exercise regime~     alongside their habitual diet . All participants will consume a Vitamin D3 tablet~     (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of~     the intervention will be 16 weeks.~   "
51836|NCT02378636|"~     This will be a prospective, open-label, 125 subject (maximum), two-year multicentre~     investigation to assess the safety, effectiveness and rotational stability of the modified~     600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.~   "
51807|NCT02379013|"~     The purpose of this study is to determine more objective, central and peripheral indices of~     fatigue state by exploring the neural and behavioral correlates of the alert process while~     keeping the idea to corroborate these results with those obtained during the performance of~     physical exercises and neuropsychological tests classics of attention, motivation, and~     functions evaluation. The interest of this study is to manipulate and compare the phasic and~     tonic alert mechanism through the activation of an extrinsic motivational system during~     fatigue. The investigators have chosen the alert since it is a basic cognitive process~     defined as the ability to increase attentional resources with the expectation of a target~     stimulus resulting in reduced response time. It can be phasic (extrinsic), favored by the~     presence of a warning signal preceding the target (preparation time) or tonic (intrinsic)~     occurring without warning signal (wakefulness). The evaluation of the alert is classically~     realized by a simple reaction time task with the presence or not of warning signal~     soliciting wether the tonic alert or the phasic alert.~      The investigators suppose to revisit the healthy population with brain model alert issued in~     2010 which highlighted the predominant role of the regions of the dorsolateral prefrontal~     cortex, parietal, cingulate and thalamus (non-motor) in maintaining attention and temporal~     preparation alert task.~      The investigators identify also functional, motor and cognitive components of basal ganglia~     of thalamus. Cognitive-motor paradigm and neurological dysfunctions observed in multiple~     sclerosis population will help to identify and separate the cognitive role and motor brain~     regions, particularly the thalamus and basal ganglia. New neurological hypotheses are~     proposed~   "
51808|NCT02379000|"~     Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after~     irradiation the exudation increases resulting in an exudative retinal detachment requiring~     vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is~     capable to decrease the exudation. If there is any advantage in a combined treatment this~     study will investigate.~   "
51809|NCT02378987|"~     The aims of this study:~        1. to investigate the difference in motor speech functions among children with cerebral~          palsy (CP) of different motor severities.~        2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase~          among children with CP of different motor severities.~        3. the correlation between motor severity, personal factors, family factors, language~          ability and motor speech in children with CP.~        4. to identify the variables that can predict motor speech functions in children with CP.~   "
51810|NCT02378974|"~     The objective of the study is to evaluate the safety and the potential therapeutic effects~     per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects~     comprised of 2 treatment cohorts:~      Cohort 1 : Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0~      Cohort 2: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7~   "
51811|NCT02378961|"~     This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir~     (SOF)/velpatasvir (VEL) fixed dose combination (FDC) in adults with chronic non genotype 1~     hepatitis C virus (HCV) infection.~   "
51812|NCT02378948|"~     The aim of this study is to investigate the effects of early start versus delayed start of~     oral intake on postoperative functional recovery after an esophagectomy.~   "
51813|NCT02378935|"~     This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir~     (SOF)/velpatasvir (VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with~     chronic genotype 1 hepatitis C virus (HCV) infection.~   "
51814|NCT02378922|"~     This clinical trial studies gene-modified, human immunodeficiency virus (HIV)-protected stem~     cell transplant in treating patients with HIV-associated lymphoma. Stem cells, or cells~     which help form blood, are collected from the patient and stored. They are treated in the~     laboratory to help protect the immune system from HIV. Chemotherapy is given before~     transplant to kill lymphoma cells and to make room for new stem cells to grow. Patients then~     receive the stem cells that were collected from them before chemotherapy and have been~     genetically modified to replace the stem cells killed by the chemotherapy.~   "
51815|NCT02378909|"~     Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect~     nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense~     of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin~     resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged~     tissues especially if the patients have diseased blood vessels causing a lack of blood to~     areas of the body including the feet (called ischaemia).~   "
51816|NCT02378896|"~     This study will evaluate the effects of a computerized training program coupled with~     cognitive behavioral therapy (CBT) for OCD.~   "
51817|NCT02378883|"~     The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Micro~     Catheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous~     malformation (AVM) embolization procedures.~   "
51818|NCT02378870|"~     This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study~     evaluating efficacy and tolerability of Osteodex of patients with metastatic castration~     resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known~     substances; dextran, alendronate and guanidine.~      The objective of the study is to evaluate the relative change of response markers to bone~     metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall~     survival, PSA response, other response markers related to bone metabolism (S-CTX and~     osteocalcin), safety, tolerability, pain and quality of life.~   "
51819|NCT02378857|"~     Cross-sectional study of a national cohort of adolescents with univentricular congenital~     heart defects and Fontan type palliation.~   "
51820|NCT02378844|"~     A prospective, double-blind, randomized, sham-controlled, multicentre investigation.~   "
51821|NCT02378831|"~     The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological~     recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG~     data, performed by a trained and authorized scorer, according to the AASM (American Academy~     of Sleep Medicine) guidelines, serves as a gold standard for all determinations of~     efficacy.~   "
51838|NCT02378610|"~     The relationship between the gut microbiota and stress is poorly studied in humans. In this~     study we aim to look for if stressed persons have different levels of key bacterial groups~     compared to the levels in non-stressed persons.~   "
51822|NCT02378818|"~     This research focuses on disorders of motivation, responsible for a disability that patients~     experience daily. It is a disorder that affects behavior, especially social. Mechanisms,~     which result in these disorders, are poorly understood. This ignorance is responsible for~     the lack of effective therapy. The investigators realize this work in order to better~     understand the motivational deficits. The objective of the study is to characterize the~     cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the~     question posed in the research, it is planned to include 35 people with schizophrenia, 35~     people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .~   "
51823|NCT02378805|"~     The hereditary type IV collagen disease Alport syndrome inevitably leads to end-stage renal~     disease. Currently there are no therapies known to improve outcome. Our non-interventional,~     observational study investigates, if medications such as ACE-inhibitors can (1) delay time~     to dialysis and (2) improve life-expectancy within three generations of Alport-families in~     Europe.~   "
51824|NCT02378792|"~     Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator~     to patients with refractory epilepsy.~   "
51825|NCT02378779|"~     Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59~     have admitted suffering from a decrease in, or loss of control of, their ejaculation. The~     quality of life of patients and their partners is impaired compared to men not suffering~     from premature ejaculation. Economically, the impact of the disease are significant. In the~     year preceding the detection of premature ejaculation patients visit twice their physician.~     The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting~     room, considered it important to talk with their GP about their sexual concerns. Almost half~     of them preferred that their GP initiate any discussions about sexuality. More than two~     thirds of the respondents would have liked their GP to signal his or her open-mindedness by~     directly addressing sexual topics during the consultation. In 2008 a qualitative study~     brought to the fore the strategies used by GPs to initiate the discussion on premature~     ejaculation . GPs who mentioned premature ejaculation with their patient described three~     attitude-related strategies and three investigative strategies.~   "
51826|NCT02378766|"~     The purpose of this study is to evaluate the efficacy of a web-based tailored intervention~     to support persons living with HIV (PLHIV) manage the demands inherent to their health~     condition, particularly as regards to the adoption of health behaviours such as being~     physically active, following a healthy diet and quitting smoking.~      This randomized controlled trial is currently conducted entirely online at~     www.lhivehealthy.ca~   "
51827|NCT02378753|"~     The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread~     and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood~     and secretions, lack of appropriate personal protective equipment (PPE) and challenges in~     following infection control and prevention protocols put healthcare workers at high risk~     during outbreaks, and direct contact with the bodies of deceased Ebola victims can also~     sustain community transmission. This study will accelerate introduction and use of~     monovalent recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among~     healthcare workers and frontline personnel involved in the Ebola outbreak response in Sierra~     Leone, while concurrently evaluating the safety and efficacy of the vaccine.~      This is an unblinded, randomized trial with phased vaccine introduction in the target~     population. Participation in the study will be voluntary and open to adults 18 years of age~     and older who are at high risk of exposure to Ebola infection through their daily work and~     who work in a selected study area.~   "
51828|NCT02378740|"~     Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to~     reduce pain while also decreasing intraoperative and postoperative opioid requirements when~     used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive~     antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is~     believed to block the development of central sensitization and wind-up phenomenon,2,3 which~     may be helpful in preventing acute and chronic pain after repetitive insults. In a~     systematic review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was~     found to be a useful addition to standard postoperative pain management practice with~     opioids in 54% of studies.1 The studies that did not show a significant effect were in~     patient populations with low opioid requirements. Therefore, it has been suggested that~     future clinical trials be focused on patient populations with significant post-operative~     pain, such as spine surgery and major orthopedic surgery not amenable to regional analgesia,~     and postoperative pain in patients on chronic preoperative opioid therapy.1~      There are few studies examining outcomes after ketamine in the perioperative period after~     spine surgery. Loftus et al randomized patients with a history of chronic preoperative~     opioid use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus~     placebo and found a 30% reduction in morphine consumption at 48 hours and an approximately~     25% reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and~     at 6 weeks.4 Although this study provided evidence that there may be reduction in long-term~     postoperative pain, additional studies are needed to provide evidence that this effect is~     sustained beyond the 6-week period.~      We are interested in examining ketamine more closely in spine surgery because this patient~     population experiences significant postoperative pain that may be difficult to control due~     to preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF~     patients specifically because it is a common spine procedure throughout the United States~     and the patients have significant opioid requirements postoperatively. In a study examining~     the effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and~     lumbar surgery, patients in the placebo group (and thus only receiving fentanyl PCA)~     reported mean VAS scores of 4-5 with movement while receiving opioids.5~      Further, while previous studies have shown an opioid-sparing effect of ketamine as measured~     by opioid consumption and a decrease in pain as measured by VAS scores, no study to our~     knowledge has examined quality of recovery after intraoperative ketamine infusion. The~     Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of~     recovery after anesthesia based on forty questions in five dimensions,6 and this score has~     been shown to be a reliable and valid outcome for patients undergoing both spine and cranial~     surgery.7 QoR-40 is also of interest because it should be able to provide a global~     assessment of the possible benefit or harm of using ketamine in patients by simultaneously~     characterizing the detrimental side effects as well as the positive benefits of ketamine~     when used as an infusion at subanesthetic levels (studies thus far have shown that there are~     minimal side effects such as hallucinations).1,4~      Significance:~      Previous studies have shown an opioid-sparing effect of ketamine, however further research~     is warranted in patients whose pain may be difficult to control and whether this effect is~     sustained. ACDF patients experience significant pain post-operatively, and ketamine may~     improve their quality of recovery due to its opioid-sparing effects and prevention of~     chronic pain. Further, patient centered outcomes as measured by the QoR-40 have not been~     reported in the literature when ketamine, or other opioid sparing anesthetics, have been~     administered. This study will not only determine if the moderate dose of ketamine is~     beneficial or detrimental to the recovery of patients but also whether it can improve long~     term patient function, presumably by decreasing central pain sensitization. In addition,~     this study will set the stage for further RCT's examining other analgesic strategies in~     cervical spine surgery patients (i.e., intraoperative lidocaine infusions, volatile~     anesthetic vs. propofol as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The~     overall goal would be to develop a multi-faceted regimen that decreases the postoperative~     inpatient opioid requirements of these patients and may facilitate long term recovery.~      The research questions:Does ketamine improve the quality of recovery at 24 hours after~     anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators~     hypothesize that ketamine will improve the quality of recovery after ACDF surgery~   "
51829|NCT02378727|"~     The purpose of this pivotal study is to demonstrate safety and effectiveness of the~     CompuFlo® Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural)~     for the epidural space verification.~      The CompuFlo® Epidural System is limited by federal law for investigational use only in~     United States of America and has received CE mark in European Union.~   "
51830|NCT02378714|"~     Persons who struggle with depression smoke at high rates and experience low quit rates in~     treatment. The best way to improve cessation treatment for this underserved population~     remains unknown. The proposed trial tests whether the combination of varenicline and~     behavioral mood management treatment enhances long-term abstinence for depressed smokers~     and, if so, whether this treatment achieves its effects through addressing the unique~     psychological factors that appear to maintain tobacco dependence for these smokers.~   "
51831|NCT02378701|"~     The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1~     in patients with MDS.~   "
51832|NCT02378688|"~     The primary objectives of the study are:~        -  To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe~          active Crohn's Disease（CD）~        -  To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active~          CD.~   "
51833|NCT02378675|"~     Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue~     as well as placental tissue and have been shown to be potential mediators of insulin~     resistance. In each pregnancy, a physiological Insulin resistance syndrome occurs to ensure~     that the fetus is sufficiently supplied with glucose. Due to their impact on glucose~     transport mechanisms adipocytokines play an important role for the development of insulin~     resistance.~      Gestational diabetes mellitus (GDM) is one of the most common pregnancy - associated~     diseases with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. It~     is associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy,~     premature delivery and intrauterine death. Furthermore, up to 50% of women with GDM develop~     Type 2 Diabetes Mellitus (DM2) within the following ten years after pregnancy. GDM seems to~     be a potent risk factor for the development of DM2 in later life by sharing a number of~     epidemiological, physiological and genetic characteristics with DM2. Therefore, alterations~     in adipocytokine levels in women with GDM, if present, may resemble those observed with DM2.~      Furthermore, the exact pathogenesis of GDM is not completely understood, however, increased~     insulin resistance is a well demonstrated mechanism.~      Adipocytokines are known to alter insulin resistance through several mechanisms described in~     the literature. The investigators therefore expect a possible relationship between the above~     described adipocytokines and gestational diabetes mellitus.~      Results of the HAPO-Study have shown a significant association between fetal outcome and~     mean blood glucose levels in women suffering from GDM. The HAPO Study group supposed a~     possible relationship between GDM and fetal insulin levels and used C-Peptide to quantify~     fetal hyperinsulinemia.~      A recent study suggests that not only hyperglycemia but also altered maternal lipid~     metabolism may constitute a risk factor for macrosomia in GDM.~      In summary, the investigators aim to illuminate a possible association between the~     adipocytokines Apelin, Omentin, Resistin and Visfatin, lipid metabolism and gestational~     diabetes mellitus.~   "
51834|NCT02378662|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment in Peritoneal Dialysis patients~   "
51839|NCT02378597|"~     To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.~   "
51841|NCT02378571|"~     The overall purpose of this project is to determine the feasibility of conducting a large~     scale randomized clinical trial that compares remote monitoring of adherence to loop~     diuretics using a wireless electronic pillcap with usual care among recently hospitalized~     heart failure patients. The long-term goal of this program of research is to determine the~     effect of the adherence telemonitoring intervention on medication adherence and hospital~     readmissions among recently hospitalized heart failure patients.~   "
51842|NCT02378558|"~     This small pilot will allow surgeons to perform wireless breast lumpectomies using a new~     magnetic technology. This is a continuation of a previous project testing the technology,~     and the breast surgeons comfort level using this new technology.~      The aim of this project is to develop a new technique for surgical excision of lesions~     either through surgical biopsy or lumpectomy. The current standard of care involves placing~     a needle then slender wire through the lesion under image guidance by a radiologist. The~     surgeon then removes the lesion using the wire as a guide. This new technique would place a~     magnet through the lesion under image guidance by a radiologist. The surgeon would then use~     the MagneProbe in the operating room to locate the magnet and remove the lesion. This new~     technique would eliminate the use of a wire that protrudes from a patient's breast. This~     wire is usually placed on the day of surgery, prior to the procedure. The goal of this new~     technique is to eliminate wire placement and increase patient comfort throughout the day of~     her surgery.~   "
51843|NCT02378545|"~     The motivation for this study comes from a desire to improve the mortality of patients with~     sepsis. Oxygen is cheap, readily available and is included in current United Kingdom~     Emergency Department guidelines, but it may also be harmful to patients with sepsis - it is~     important to know if this is the case.~      This study is a pilot study to also assess the feasibility of delivering a larger adequately~     powered study.~   "
51844|NCT02378532|"~     Patients with a glioblastoma (GBM) have a poor prognosis with a median survival of 14.6~     months after maximal treatment with a resection and chemoradiation. Since the pivotal trial~     evaluating the effect of temozolomide (TMZ), overall survival has not increased.~      Treatment of GBM xenografts in vivo with chloroquine (CQ), an antimalarial agent, has been~     shown to reduce the hypoxic fraction and sensitizes tumors to radiation. Epidermal growth~     factor receptor (EGFR) amplification or mutation is regularly observed GBM and is thought to~     be a major contributor to radioresistance. The most common EGFR mutation in GBM (EGFRvIII)~     is present in 50-60% of patients whose tumor shows amplification of EGFR. EGFR provides~     cells with a survival advantage through autophagy when exposed to stresses such as hypoxia~     and nutrient starvation. This effect is even more pronounced in EGFRvIII overexpressing~     tumors. Previously, the potential effect CQ has been demonstrated in a small randomized~     controlled trial in GBM treated with radiotherapy and carmustine, which showed a trend~     towards increased overall survival. However, as the intracellular effects of chloroquine are~     dose-dependent the maximum tolerated dose for CQ in combination with concurrent radiotherapy~     with daily temozolomide needs to be established.~   "
51845|NCT02378519|"~     The aim of the study is to evaluate the effects of a the multimodal treatment with a~     web-based self-help program with cognitive behavioral therapy coaching and individual~     tailored physiotherapy on workability, health behavior and pain symptoms for persons with~     persistent pain.~   "
51846|NCT02378506|"~     Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the~     high capacity process. Descriptive results will be provided however a formal hypothesis will~     not be tested in this trial.~   "
51847|NCT02378493|"~     This is an observational study that does not change routine care.~      The primary objective of this study is to investigate the role of~     antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed~     antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of~     antibiotics.~   "
51848|NCT02378480|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to linezolid in the treatment of adults with acute bacterial skin and skin structure~     infections.~   "
51849|NCT02378467|"~     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice~     daily for 48 weeks improves the lung clearance index by multiple breath nitrogen washout in~     comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 5)~     with cystic fibrosis.~   "
51850|NCT02378454|"~     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children~     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each~     participants will perform the test (LCI) in duplicate on each device.~   "
51851|NCT02378441|"~     This study is designed to evaluate safety and pharmacokinetic properties of the two~     treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg~     and metformin SR 750mg, in healthy volunteers.~   "
51852|NCT02378428|"~     This is a Phase II study for patients with MIBG avid tumors. The study is to determine the~     response rate to <131>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma~     or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating~     the tolerability and safety of the study agent by evaluating the hematopoietic and~     non-hematopoietic toxicity of <131>I-MIBG therapy. Tumor response will be evaluated by~     comparing the patient's disease pre-treatment against the patient's day +42 post <131>I-MIBG~     treatment. The evaluations may include the following: <131>I-MIBG scan, CT or MRI, urine~     catecholamine, bone marrow analyses and any other tests considered standard of care for~     cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG~     avid. Patients must also have a stem cell source for autologous rescue in the event of~     protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as~     the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an~     alternative. This study will provide data for future clinical trials utilizing <131>I-MIBG~     therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety~     components to accomodate this treatment. <131>I metaiodobenzlguanidine (<131>I-MIBG) is a~     radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially~     used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and~     other neuroendocrine tumors. <131>I-MIBG was subsequently used as an therapeutic agent for~     these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported~     response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with ~50% of~     patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic~     toxicities have been mild. Most recently, trials have been conducted combining the study~     agent with myeloablative chemotherapy and stem cell reinfusion have been performed with~     initial response rates of ~50%.~   "
51887|NCT02377973|"~     The overall aim is to provide a detailed description of growth, development and risk factors~     for later disease, especially obesity and metabolic disease in infants born by obese mothers~     and to compare them with a group of infants born by mothers without any restriction in~     prepregnancy BMI (SKOT I).~   "
63178|NCT02230319|"~     The purpose of this study is to determine if cryotherapy can effectively decrease the rate~     of neuropathy in patients undergoing weekly paclitaxel treatments.~   "
51853|NCT02378415|"~     The objective of this double-blinded placebo-controlled pilot study is to determine whether~     a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed~     patients with or without suicidality has a significant rapid antidepressant effect in the~     acutely depressed population. The study will pursue as a primary outcome measure whether a~     significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly~     after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome~     measure will be assessed to determine whether this single infusion of ketamine has a~     sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in~     BDI score. Suicidal ideation will also be assessed for determination of any reduction and~     sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS),~     Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.~   "
51854|NCT02378402|"~     The objective of this 3-year project is to develop myocardial MRS, in particular lipid~     (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart~     failure (HF). Investigators will elucidate how and, to what extent, lipid and creatine~     levels of the heart contribute to heart failure. The first year is a cross-sectional study.~     Investigators aim to compare the MRS of normal subjects and that of stable HF patients in~     recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled,~     with 20 subjects in each group. In the 2nd and 3rd years, investigators plan a prospective~     longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at~     three time points, i.e., disease onset, 6 months and one year after treatment, and will be~     followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will~     be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine~     and lipids, will be correlated with the disease course, patient biochemistry data and~     clinical outcome. Investigators expect to make MRS to become an integral part of a clinical~     cardiac MR protocol.~   "
51855|NCT02378389|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in~     combination with Docetaxel in patients with HER2 positive advanced gastric cancer.~   "
51856|NCT02378376|"~     During this project the amount of SCFA produced in the colon after consumption of 2~     different 13C-labelled wheat fiber fractions will be quantified.~   "
51857|NCT02378363|"~     The main objective is to develop an educational program and to measure the impact on social~     representations identified as acting in the prevention of cancer. Child should write, draw~     and speak about cancer signifiance to identify individual conceptions and representations of~     health and cancer in children aged 9 to 12 years in school.~   "
51858|NCT02378350|"~     This is a multicenter, randomized, open-label study to compare QoL in subjects with~     end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.~      Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal~     dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1~     year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire~     domain of burden of kidney disease.~      Secondary Objectives: The secondary objectives are to observe and summarize the following~     parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL~     instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items,~     which will be compared between the 2 treatment groups:~        -  Mortality rates~        -  Switch (PD to HD or HD to PD)~        -  Transplantation rate~        -  Cause of death~        -  Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the~          volume of distribution of urea [Kt/V urea] to determine the proportion of subjects~          meeting standards of care for dialysis adequacy).~        -  24-hour urine volume~        -  Change in hemoglobin and S-phosphate levels, and the percentages of subjects with~          values within the target range~        -  Change in serum albumin~        -  Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory~          test findings with clinical significance~   "
51859|NCT02378337|"~     Identify the best combination of predictive variables that influence ionizing radiation dose~     and improved image quality through analysis and quantification of PET-CT images in~     simulators and patients.~   "
51860|NCT02378324|"~     Several reasons can explain non-attendance in cervical cancer screening. In low resource~     settings the attendance is even lower. The effect of fee as contributing reason of non~     attendance has not been studied before why the investigators decided to study this in a low~     resource setting as a randomised trial.~   "
51861|NCT02378311|"~     Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle~     injuries have remained one of the commonest causes of paediatric abdominal trauma for over~     60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of~     those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major~     paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently~     minor falls; they are not unique to riders performing stunts[5].~      One small study found that the metal handlebar ends were often exposed on bikes of children~     sustaining severe abdominal injuries[6]. Most European safety standards do not test grip~     durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal~     handlebar tube.~      This feasibility study aims to test the research methods that will be used in a subsequent~     nationwide multicentre study. The main study will investigate the association between~     injuries and handlebar grip condition.~      Children attending study hospitals with any bicycle or kick scooter injury will be invited~     to participate. Parents of injured children will be invited to complete questionnaires~     regarding circumstances surrounding the injury and condition of the handlebar ends on the~     bike or scooter involved. Clinical information regarding the injury will also be collected.~     The handlebar end condition will be compared between children sustaining a handlebar end~     injury [Cases] and riders whose injury did not involve the handlebar [Controls].~      If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries,~     injury prevention strategies can focus on methods to prevent damage occurring to grips~     through day-to-day use. If no such association is found, prevention strategies can be~     focused elsewhere, such as on design of effective protective clothing.~      Data collection for this feasibility study will occur between March 2015 and September 2015.~      The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.~   "
51862|NCT02378298|"~     Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients~     with Graves disease. Its combination of protrusion affecting the looks of the patient and~     pain is often severely affecting the quality of life among these patients.~      The standard treatment for this illness today is intravenous glucocorticoids together with~     methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients~     that do not respond to or relapse after conventional therapy.~   "
51863|NCT02378285|"~     The purpose of this study is to assess efficacy of two intra-tendinous injections of~     platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared~     compared to two intra-tendinous injections of saline solution (placebo).~   "
51864|NCT02378272|"~     The aim of the project is to explore if a complementary addition of a care manager for~     depression treatment in the primary care setting has positive effects concerning reduction~     of the patients' depressive symptoms as well as improvement of daily function and quality of~     life in a short- and long-term perspective compared with the traditional Swedish primary~     care organization. The aim is also to evaluate the care manager function in a health~     economic perspective.~      The specific aims are to develop and evaluate an evidence-based care manager program for~     patients with mild to moderate depression and to compare the evidence-based care manager~     program to treatment as usual (TAU) in terms of their short- and long-term effects on~     symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to~     perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the~     effects of the program on patients' health in relation to the running costs of the program.~   "
51865|NCT02378259|"~     Severe childhood obesity is associated with both immediate and chronic health problems and a~     severe impact on psychosocial development. Medical and behavioural interventions rarely~     result in the significant, durable weight loss necessary to improve health outcomes.~      This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be~     randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense~     conservative treatment and possibly surgery as they have become 18 years.~   "
51866|NCT02378246|"~     Aims~        -  To compare milk iodine concentration (MIC) in colostrum, urinary iodine concentration~          (UIC) and TSH in the newborn child to pregnant women receiving 150 µg iodide or placebo~        -  To compare UIC, thyroglobulin (Tg), free tetraiodothyronine (FT4) and TSH in pregnant~          mothers on 150 µg iodide or placebo Background Iodine deficiency results in~          hypothyroidism and goiter and during the pregnancy increases the risk for abortion or~          cognitive and other abnormalities. According to the WHO recommendations, UIC for~          pregnant women should be 150-249 ug/L. A study confirmed in 2007 iodine sufficiency in~          Sweden. It is debated whether or not iodide shall be given to pregnant women in iodine~          sufficient populations: In Japan, the median UIC in pregnancy was 195-220 µg /L, in~          Switzerland 116-166 µg /L and in US 125 µg /L. Our hypothesis is that an iodine~          supplementation of 150 µg/day is needed during pregnancy in Sweden in order to ensure~          normal iodine and thyroid hormone status in mothers and newborn children.~      Project description This is a prospective, double-blinded placebo-controlled trial of 200~     pregnant women and their children. Mothers are randomized to 150 µg/day iodide~     supplementation or placebo for 26 weeks. In parallel 90 healthy female controls are~     recruited from the same community stratified for age and smoking habits. Patients are~     included after the first mother health care (MVC) visit by the midwife at Skövde. UIC,~     U-creatinine, thyroid hormones, Thyroid stimulating hormone (TSH), Thyroglobuline (Tg) and~     thyroperoxidase antibodies (TPO-ab) are collected and a simple questionnaire is filled in~     week 10±2 weeks of pregnancy and placebo/iodide is started. Selenium and iron will also be~     measured. The same measurements are collected in week 25±1 week and week 36±2weeks. Directly~     after delivery (within 5 Days), MIC and UIC in the mother as well as UIC and TSH in the~     newborn child are collected and a simple questionnaire is filled in. Weight, length and~     APGAR in the child and pregnancy complications are registered. Blood is also frozen for~     future analyses.~      Controls are collected from a randomized sample attain by the Swedish Tax Agency of~     premenopausal women from the same community stratified for age and smoking habits. UIC,~     u-creatinine, FT4, TSH, Tg, TPO-ab, selenium, iron and samples to be frozen are collected~     and a questionnaire is filled in. The primary purpose for having a control population is to~     ascertain that the normal population in the area of Skövde is iodine sufficient.~   "
51867|NCT02378233|"~     The aim of the study is to measure urinary milk iodine concentration (MIC), iodine~     concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in~     breast-feeding women, and UIC in their nursing infants to determine if the levels are~     adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in~     breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this~     sub-population - lactating women and nursing children-, and that this can be influenced by~     iodine supplementation. Adequate thyroid hormone and iodine levels are very important for~     small children, when the plasticity of the brain is greatest.~      This is as a prospective, double-blind, placebo-controlled study of 221 mothers and their~     infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are~     randomized to 150 µg/day iodide supplementation or placebo.~      Pregnant women are asked for participation on a visit in pregnancy week 37, at the mother~     health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 3 months for~     each individual and begins by sampling A (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy,~     when mothers also get randomized to 150 µg iodine or placebo. New sampling B (UIC, TSH, FT4,~     MIC ) is collected when the baby is 3 months old. Thereafter the study is completed. In~     parallel, 90 healthy non-pregnant, non-lactating women in the same age range are recruited~     and followed with UIC, TSH, FT4, TPOab for 6 months as a control group. In each case a~     simple questionnaire is filled and blood is also frozen for future analyses.~   "
51868|NCT02378220|"~     Patients meeting eligibility criteria will be randomized into two groups, one receiving~     pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this~     open-label trial, a pharmacist will make medication therapy recommendations using YouScript®~     Personalized Prescribing System for patients who receive genetic testing and standard drug~     information resources per usual for patients who do not undergo pharmacogenetic testing.~   "
51869|NCT02378207|"~     The aims of the phase 1b trial described here are to facilitate identification of assays and~     immune responses that could then be evaluated as correlates of risk and correlates of~     protection in efficacy studies and ultimately to provide leads for biomarkers of protection~     against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating~     the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).~   "
51870|NCT02378194|"~     Chronic renal failure is a syndrome that renal function is decreased, and the patient number~     is increasing. In addition, patients on dialysis have also increased. Depending on the~     chronic renal failure aggravated, the deterioration of life caused by the conduct of~     dialysis patients is caused. In addition, a problem in dialysis treatment is ongoing~     economic burden surface to increase the life of the patient and family. A solution to this~     problem is, or stops the progression of chronic renal failure prior to dialysis, it is~     necessary to delay. As a treatment for inhibiting the progression of chronic renal failure~     is present, along with diet and blood pressure-lowering drugs or a drug therapy used by~     kremezin. However, the effect is not enough, new drug development is required.~      HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found~     during the search active substance that appear when the inflammation in animals. The~     investigators confirmed that the substance is present in the urine of a person during the~     study, and later established a link between kidney disease hypotheses. When performing the~     test in animal model renal failure, chronic renal Through the non-clinical testing of the~     HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity~     test and antigen tests) showed that a very low toxicity. When going through the review of~     the safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory~     safety and tolerability. And pharmacokinetic results from the body's absorption in healthy~     subjects had been done well, a linear correlation was observed. Finally, it was confirmed~     that the most rapidly excreted into the urine.~      This study is a Phase 2a clinical trials performed in patients with chronic renal failure in~     3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal~     failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure~     progression and dose setting, and to determine the safety.~   "
52287|NCT02372773|"~     This study is being done to learn more about normal thinking and behavior, mild thinking and~     behavior problems, Frontotemporal Dementia and other forms of dementia in families in which~     one or more relatives have a mutation associated with Frontotemporal Dementia.~   "
51871|NCT02378181|"~     This study deploys a strategy to develop and evaluate a training-efficient, multimedia~     patient-centered Health Education Toolkit to promote shared decision making between~     counselors and patients. An existing evidence-based toolkit intervention will be adapted and~     redesigned by a patient and provider team into an engaging, narrative graphic novel~     curriculum useful in group and individual counseling. The proven behavioral interventions~     will be augmented with health education material focused on medication assisted treatment~     (MAT) and HIV risk reduction. We will test whether exposure to the Toolkit (TK) can reduce~     substance use and HIV risk, while increasing engagement with MAT.~   "
51872|NCT02378168|"~     Retrospective analysis of a 6-month follow up within a randomised controlled study in~     cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with~     sevoflurane)~   "
51873|NCT02378155|"~     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation~     in a non-invasive manner. Through the use of near infrared light, the difference between~     oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a~     numeric result can be calculated.~      Since atrial fibrillation (AF) has been linked with an increased risk for the development of~     neurocognitive deficits, a longer period of AF might be associated with a higher risk for~     neurocognitive deficits.~      It is hypothesized that there is an increase in the regional cerebral oxygen saturation~     (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.~   "
51874|NCT02378142|"~     The purpose of this study is to test any good and bad effects of the study drug pazopanib.~   "
51875|NCT02378129|"~     The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and~     compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT~     (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White,~     Gloucester, UK) at 2-year follow-up.~   "
51876|NCT02378116|"~     Because atrial fibrillation occurs frequently in heart surgery patients, our overall~     hypothesis is that systematic closing the left atrial appendage during surgery will reduce~     cerebral embolism coming from the thrombus formation in the left atrium.~      The specific hypothesis which sought tested is that closure of the left atrial appendage in~     connection with elective CABG and / or valve surgery will lead to fewer strokes and micro~     cerebral infarcts measured by MRI.~   "
51877|NCT02378103|"~     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese~     XinJiang Province patients.~   "
51878|NCT02378090|"~     The purpose of this observational study is to characterize individuals in Mexico who seek~     medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI),~     describe seasonal pattern of the pathological agents associated with ILI and SARI and to~     identify changes in severity of disease caused by a specific agent.~   "
51879|NCT02378077|"~     This study is being done to better understand the relationship between inflammation and~     insulin resistance in your Adipose (fat) Tissue .~   "
51880|NCT02378064|"~     The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker~     versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG~     PET/CT imaging of carotid artery.~   "
51881|NCT02378051|"~     The purpose of this study is to examine whether Staying Strong With Schools, a school-based~     intervention to support military-connected children, will be helpful for school~     professionals and military parents in supporting specific needs of this population of~     children. As part of the partnership between three school districts in Massachusetts and the~     Red Sox Foundation and Massachusetts General Hospital Home Base Program, the investigators~     will examine the efficacy of a training delivered to these schools. The schools will be~     randomly divided into two groups (like a toss of a coin). Half of the schools will receive~     the training in 2014-2015, and the other half will be waitlisted and receive the training~     the following year (2015-2016). All participants (school teachers, military-connected~     children, and their parents) will be asked to complete questionnaires the first year. The~     investigators hypothesize that, compared to the control schools, at the end of the school~     year, SSWS schools will be associated with: (1) greater sense of competence and quality of~     relationships with military-connected children (MCC) among school professionals; (2) lower~     parental distress and increased parental sense of competence and general family functioning;~     and (3) increased social support, and fewer academic, emotional, and behavioral problems~     among MCC. The investigators hypothesize that an increase in school professionals' sense of~     competence in identifying and handling MCC's needs, increased quality of relationships with~     MCC, lower parental distress, increased parental sense of competence, and increased general~     family functioning will mediate the efficacy of SSWS on MCC's social support and~     psychosocial functioning.~   "
51882|NCT02378038|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a~     multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to~     characterize anti-tumor activity and collect safety data on patients with Richter's~     Transformation.~   "
51883|NCT02378025|"~     The purpose of this study is to determine whether yoga is effective for the treatment of~     chronic pain in Gulf War Illness.~   "
51884|NCT02378012|"~     This randomized clinical trial studies iPad use in reducing anxiety and depression in~     patients undergoing bone marrow transplant. A tablet device like the iPad can provide access~     to music, television, movies, books, and the Internet. It also contains a video conferencing~     system that can allow patients to communicate with family members and other members of their~     social support team. With these capabilities, an iPad distribution program may help lessen~     patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may~     help doctors better understand how patients use their computers and tablets while in the~     hospital so that the software and applications of the iPad can be made more useful.~   "
51885|NCT02377999|"~     An exploratory open label, single treatment trial of anogenital warts with Picato® repeated~     up to 2 times with two weeks intervals.~   "
51886|NCT02377986|"~     Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve~     symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an~     intervention to add in-home decluttering practice to the BIT workshop.~   "
53995|NCT02350361|"~     Here we are going to find a method by using available multiple drugs including angiogenesis~     medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but~     have responsed to it before.~   "
51888|NCT02377960|"~     The purpose of this pragmatic multi-centre, cluster randomized controlled trial is to test~     the effectiveness of tailored SMS-text message support combined with an~     information-motivation-behavioral skills (IMB) model-based initiation of medication in~     helping outpatient care patients with hypertension to achieve blood pressure target and to~     enhance medication adherence.~   "
51889|NCT02377947|"~     This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West~     Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the~     treatment of deep grade HE (West Haven Criteria). The study will be conducted~     retrospectively in a single center of a multispecialty tertiary care hospital in India, in~     which lactulose retention enema is the mainstay of management of cirrhotic patients with~     grade 3 or 4 HE (West Haven criteria). Dosing of lactulose retention enema in this study~     will be done according to the dosing described for rectal administration of lactulose~     (India): 300ml of lactulose mixed with 700ml of potable water to be used as a retention~     enema; the enema is to be retained for 30-60 minutes and repeated every 4-6 hours until the~     patient is able to take oral medication. This treatment regime is also the standard protocol~     of management of deep grade HE (West Haven criteria) in the study center. The standard~     treatment protocol of deep grade HE (West Haven criteria) of the study center will also~     ensure that all known contraindications of lactulose will be respected before administration~     of lactulose retention enema to the study patients. The retrospective hospital records of~     the patient population of interest within the past 6 months will be identified, and these~     records will be used to collect data required for analysis.~   "
51890|NCT02377934|"~     In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the~     tumour is limited by the risk of radiation induced lung damage. This damage is characterized~     by parenchymal damage and vascular damage. In rats, we have found that radiation-induced~     vascular damage results in increased pulmonary artery pressure. Interestingly, the~     consequent loss of pulmonary function could be fully explained by this increase in pulmonary~     artery pressure. We hypothesize that also in patients a radiation induced increase in~     pulmonary artery pressure can be observed after radiotherapy, which may contribute to the~     development of radiation pneumonitis.~      The objective is to test the hypothesis that radiotherapy for lung cancer induces an~     increase in pulmonary artery pressure.~   "
51891|NCT02377921|"~     UX001-CL301 is a randomized, double-blind, placebo-controlled study to assess the safety and~     efficacy of 6 g/day sialic acid - extended release (SA-ER) treatment as compared with~     placebo in subjects with GNE Myopathy.~   "
51892|NCT02377908|"~     The objective of the study is to give a structured update on geriatric postgraduate~     education throughout Europe. The study will be performed as a cross-sectional structured~     quantitative online survey with qualitative comments. The survey content covers structural~     items, content and educational aspects of geriatric specialty training in European~     countries.~   "
51893|NCT02377895|"~     Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and~     safety study using the Allergen BioCube (ABC).~   "
51894|NCT02377882|"~     The investigators tried to explore an alternative non-depolarizing muscle relaxant~     (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid~     surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection.~     Specific time points at which the will be assessed and for EMG signals will be presented.~   "
51895|NCT02377869|"~     Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which~     enables improvement in paraprotein detection and monitoring in multiple myeloma and other~     plasma-cell dyscrasias.~      The prognostic and biological role of the HLC assay has as yet not been studied in CLL.~      Aims of the proposed study:~        1. To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL~          patients. (In addition to FLC)~        2. To study the different patterns of Immunoglobulin's subclass antibodies in the serum of~          patients with CLL and compare them to those of to healthy volunteers.~        3. To perform a sub-analysis in patients with CLL who have autoimmune phenomenon (AIHA and~          ITP)~   "
51896|NCT02377856|"~     Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia~     persists after 6 months of infection. The result of using pegylated interferon plus~     ribavirin combination therapy upon these patients remains to be explored~   "
51897|NCT02377843|"~     Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A~     central reason for low coverage is infrequent and inadequate healthcare provider~     recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide~     effective recommendations for the vaccine using participatory or efficient communication~     strategies.~      This study will evaluate the effectiveness of two communication trainings to increase HPV~     vaccination coverage among adolescent patients. We will compare HPV vaccination for~     pediatric and family medicine clinics receiving a participatory communication training,~     efficient communication training, or no training. Ten clinics will be randomly assigned to~     each study arm for a total of 30 clinics. The primary outcome of this study is to compare~     the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old~     adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the~     change in HPV vaccination initiation coverage in 13-17 year old adolescents.~   "
51898|NCT02377830|"~     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need~     advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in~     4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU~     discharge. In-bed cycling involves use of special equipment that attaches to a patient's~     hospital bed, allowing them gentle exercise while in the ICU.~      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to~     survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed~     cycling each day they are in the ICU or routine physiotherapy, both delivered by specially~     trained physiotherapists.~      Outcomes: Feasibility: The investigators will study whether patients can cycle on most days~     of their ICU stay, whether patients and their families agree to be a part of the study, and~     whether investigators can systematically assess patients' strength.~      Relevance: Effective methods of physiotherapy are needed for critically ill patients to~     minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized~     study is the second of several future larger studies about in-bed cycling in the ICU.~   "
51899|NCT02377817|"~     Back and right-sided sleeping position in pregnant women has recently emerged as a potential~     risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.~     Assuming that sleep position in pregnant women is modifiable, the same literature has~     indicated that this risk factor is modifiable; however, there is no evidence that this risk~     factor is truly modifiable.~      The proposed link between back and right-sided sleeping position in a pregnant woman and LBW~     and SB of her baby is multifactorial; however, it ultimately implicates the woman's body~     position in causing compression of one of the large veins that brings blood back to her~     heart. This compression, along with other factors relating to the woman, her placenta, and~     her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her~     developing baby, which, depending on the extent and duration, could result in LBW or SB of~     her baby. If the back sleeping position during pregnancy has a causative role in LBW and~     subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB~     could potentially be prevented by changing position to avoid back sleep. Note that 20~     million LBW and 2.6 million SB occur each year worldwide.~      Positional therapy (PT) is a safe and effective intervention for preventing people who snore~     or people who's breathing pauses during sleep from sleeping on their back - a position that~     makes their condition worse. The most basic form of PT modifies a person's sleeping position~     by either:~        -  Preventing them from sleeping on their back through restricting their movement, or~        -  Rather than restricting movement, significantly reducing the amount of time they spend~          sleeping on their back by applying pressure points to their body while they are on~          their back, which eventually causes them to shift into a different position and avoid~          lying on their back.~      The purpose of this study is to evaluate the ability of a PT intervention to modify the~     position of pregnant women from their back and right side to their left side while they~     sleep in late pregnancy.~      This study will help determine whether this potential risk factor is modifiable by way of a~     PT intervention, and whether it is feasible to intervene to reduce or prevent back and~     right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of~     pregnant women can be modified through use of a simple, inexpensive PT intervention may be~     one of the keys to achieving significant reductions in LBW and late SB rates in Canada and~     worldwide.~   "
51900|NCT02377804|"~     Stroke is the leading cause of physical disability due to the presence of spasticity.~     Different needling techniques, including Botulinum Toxin A are proposed for management of~     spasticity; however results are conflicting. The presence of spasticity in the upper~     extremity implies several impairments for daily life activities. No study has investigated~     the effects of deep dry needling inserted into the targeted spastic musculature of the~     shoulder region in patients who had suffered a stroke. The investigators will conduct a~     randomized controlled trial investigating the effects of the inclusion of deep dry needling~     into a rehabilitation program over the musculature of the shoulder region, pressure pain~     hyperalgesia and range of motion in individuals with chronic stroke. The investigators~     hypothesize that patients receiving dry needling into the spastic shoulder musculature would~     exhibit greater improvements in spasticity, pressure sensitivity and range of motion than~     those who will not receive the intervention.~   "
51901|NCT02377791|"~     Tacrolimus is a drug used commonly in kidney transplant patients to prevent graft rejection.~     Tacrolimus acts in a very narrow range in the blood for its optimum activity. If the levels~     are too high, there is a risk of kidney injury, whereas, if the levels are too low there is~     a higher risk of rejection and graft loss. Genetic differences in the gene coding for the~     enzyme cytochrome P450 (CYP3A5), which is responsible for breaking down active tacrolimus~     can contribute to variations in blood levels of tacrolimus among different individuals~     taking the same dose of the drug. Certain genetic types lead to low concentrations, whereas~     certain genetic types can lead to high levels. The proportion of individuals with different~     types of genetic variations differ among different ethnic populations. Limited data are~     available in Thai subjects or on the risk have having certain types of genetic variations on~     the risk of rejection.~      This study aims to compare the effects of different types of CYP3A5 gene variations on~     Tacrolimus drug levels and risk of acute rejection in Thais.~   "
51902|NCT02377778|"~     In this study the aim is to compare the effect of the type of anaesthetic drug used during~     oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for~     in-vitro fertilization.~   "
51903|NCT02377765|"~     This study will help to determine the effectiveness of a self-supervised, home-based~     Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining~     Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve~     Stimulation (PTNS)~   "
51904|NCT02377752|"~     This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to~     evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese~     participants with a group of rare cancers (advanced solid tumors, especially advanced soft~     tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets~     into the blood stream of Japanese participants with advanced solid tumors and how long it~     takes the body to get rid of it.~   "
51905|NCT02377739|"~     The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic~     obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous~     studies. There is only a limited number of therapeutic options for patients with severely~     progressed interstitial lung disease (ILD). The question whether chronic hypercapnic~     ILD-patients are able to profit from nocturnal NIV and thus increase their performance in~     physical training has been left unknown. Therefore, this study aims to evaluate the~     feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary~     rehabilitation.~   "
51906|NCT02377726|"~     Internet based self help program with or without support of a counselor is tested among~     anonymous Internet help seekers at an open access website.~   "
51907|NCT02377713|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's~     Disease.~   "
51908|NCT02377700|"~     Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be~     used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The~     prosthesis is immediately mechanically functional, while its physiochemical characteristics~     should enable cell infiltration and tissue formation.~      The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical~     outcomes by reducing synthetic material related complications and improving hemodynamic~     characteristics.~   "
51909|NCT02377687|"~     To study the impact of emergency high risk GI surgery on HRQOL in elderly patients,~     seventy-five years or above and to explore the patients' experience with the informed~     consent process and the status 6 months after surgery.~   "
51920|NCT02377544|"~     Hopefully this research can help to provide the optimal nutrition management from pregnancy~     so that the babies wiil born with better quality of health and reduce the morbidity and~     mortality.~      Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of~     probiotics supplementation on pregnant women to the baby especially from inflammation~     pathways. The investigators hope the result of this research can help reducing infant~     morbidity and mortality rate in Indonesia, also has a benefit for future research.~   "
51910|NCT02377674|"~     The extracardiac Fontan surgery/procedure involves diverting the venous blood from the~     inferior vena cava to the pulmonary arteries without passing through the morphologic right~     ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is~     connected to the inferior vena cava and the other end to the pulmonary artery confluence.~      Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to~     be used as an extracardiac conduit between right atrium and the pulmonary arteries. The~     prosthesis is immediately mechanically functional, while its physiochemical characteristics~     should enable cell infiltration and tissue formation.~      The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan~     surgery outcome by reducing synthetic material related complications and improving~     hemodynamic characteristics.~   "
51911|NCT02377661|"~     The aim of this prospective, randomised, open-label, multicentre clinical trial is to~     enhance blood pressure control in primary care by introducing a standardised and simplified~     titration regime with single pill combinations (SPC), comprising an angiotensin receptor~     blocker, calcium channel blocker and hydrochlorothiazide.~   "
51912|NCT02377648|"~     The CART Pilot study was designed to provide preliminary observations (about performance and~     safety) and generate hypotheses for future studies . The primary goal of the study is to~     evaluate the performance at one year of second-generation ABSORB Bioresorbable Vascular~     Scaffold (BVS)(Abbott Vascular, Santa Clara, CA , USA), the Everolimus Eluting Bioresorbable~     Vascular Scaffold, in heart transplant recipients affected by cardiac allograft vasculopathy~     (CAV) and significative coronary stenosis.~      The secondary objectives are:~        -  to collect data about the procedural and clinical outcomes post-procedure , 30 days,~          180 days and at 1,2 and 3-year follow-up, of patients who underwent ABSORB BVS~          implantation in order to investigate the safety of the device in CAV population;~        -  to evaluate the progression of the disease and the its interactions with the study~          device by using data derived from multi-imaging invasive techniques.~      The vascular reparative therapy and in particular the BVS technology showing important~     advantages in terms of endothelial preservation, adequate vasomotion, and restoration of the~     media and adventitia of the vessel wall, could represent a new and more effective~     therapeutic option, compared to bare-metal and drug-eluting stent technologies, for~     transplanted patients, since all these mechanisms may, at least in part, counteract the~     detrimental changes leading to CAV, namely constrictive remodeling and rapid atherosclerosis~     progression.~      Subjects enrolled into the clinical study will be male or female derived from the heart~     transplant recipients population of every participating center. The clinical study will~     enroll 30 subjects. Subjects, who underwent the yearly expected coronary angiography~     follow-up after heart transplant surgery, meeting the general and angiographic inclusion and~     exclusion criteria (eligibility will be assessed by Heart Team consensus) will be asked to~     sign an informed consent form. Subjects who do not meet inclusion and exclusion criteria are~     subject to the standard follow-up of heart transplant (HTx) recipients and will undergo to~     an invasive evaluation after 365 ± 28 days.~      The study comprises two distinct phases:~        -  the enrollment phase which starts with the recruitment of the first subject and it is~          planned to last one year;~        -  the follow-up phase which is planned to last three years from the enrollment of the~          last patient.~      The total duration of the study will be of four years, including both the enrollment and the~     follow-up phases~   "
51913|NCT02377635|"~     This clinical trial should prove that selenium can treat arsenic exposure in humans by~     promoting excretion. The new trial differs from previous trials in that participants will be~     maintained in a local clinic and provided with food and water from their home villages. The~     purpose of this study to determine the fate of selenium supplements in feces, urine and~     blood of volunteers living in conditions of high arsenic load in drinking water. The use of~     a clinic will enable monitoring of all intake and excretion of both arsenic and selenium,~     and will ensure that participants take their selenium doses or placebo as appropriate. This~     proof of concept is absolutely essential groundwork for any remediation strategy involving~     selenium supplements.~   "
51914|NCT02377622|"~     The study investigates the performance of a new dialyzer (Theranova 400) containing a~     membrane with increased pore sizes. The performance will be determined by the removal of~     middle molecules (with different molecular size) from the blood compartment. Two different~     Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a~     Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated~     in high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate~     will be monitored~   "
51915|NCT02377609|"~     The principal aim of this study is to define the relationship between tacrolimus~     concentrations determined from the finger prick DBS (Dry Blood Spot) method and those~     determined from blood samples collected by venepuncture in transplant recipients.~   "
51916|NCT02377596|"~     Our long term objective is to enhance the pediatrician's management of children with feeding~     difficulties in a primary care office-based pediatric practice setting. A prerequisite is to~     rapidly reach an accurate diagnosis so that appropriate therapy can be applied. To improve~     the efficiency and accuracy of the diagnostic interview the investigators have designed a~     Feeding Difficulty Diagnostic Tool (FDDT) consisting of a set of questions that fit beneath~     a 'diagnostic cover' and prompts for basic information. Depending on the answers rendered on~     the questionnaire particular diagnoses noted on the cover are flagged for consideration.~      In this study our specific objectives are 1) to assess the feasibility and acceptability of~     using the FDDT in the pediatrician's office and 2) to obtain preliminary data on the~     reliability of using the instrument in the diagnosis and management of children with feeding~     difficulties.~        -  Feasibility and acceptability are often interrelated and will be assessed in a broad~          sense by questionnaires that ascertain, for example, the amount of time needed by~          parents and staff to fill in and use the FDDT questionnaire, the ease and difficulties~          encountered in filling out the FDDT questionnaire and the understanding of the~          questionnaire by the parents.~        -  Reliability relates to the usefulness of the FDDT questionnaire for the pediatrician in~          obtaining and organizing the information obtained from the history and physical~          including anthropometric data to reach a correct diagnosis, the latter being judged in~          this study against the diagnosis reached independently by trained experts in pediatric~          feeding difficulties using a modification of their standard diagnostic interview. The~          frequency of presentation of the various diagnostic sub-categories and the extent of~          the discrepancy between the conclusions suggested by the FDDT, the pediatrician, and~          the feeding disorder experts is unknown. Therefore' this pilot study is needed to help~          determine the sample size necessary to power a more definitive study of the diagnostic~          tool's accuracy, if necessary. The investigators anticipate that at least three of the~          categories (children with excessive selectivity, children with demonstrably poor~          appetite who are vigorous and free of organic disease, and those misperceived to have~          feeding limitations) will be well represented in this preliminary study.~   "
51917|NCT02377583|"~     The general objective is to precise the role of HPA axis activity in neuropsychological~     consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA~     axis is associated with higher scores of depression and changes in hippocampal volume and~     mean diffusion.~   "
51918|NCT02377570|"~     The study investigates the performance of a new dialyzer (Theranova 400) containing a~     membrane with increased pore sizes. The performance will be determined by the removal of~     middle molecules (with different molecular size) from the blood compartment. Three different~     Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with~     a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into~     the dialysate will be monitored~   "
51919|NCT02377557|"~     To assess incidence of adverse drug reactions and use pattern of topical steroids among~     patients who are prescribed or purchase over the counter (OTC) topical steroids for skin~     conditions in Korea~   "
51961|NCT02377011|"~     A randomized controlled trial to test the whether remote delivery of cognitive based therapy~     (CBT) is clinically and cost effective when compared to treatment as usual in adolescents~     and young adults with depression who self-harm.~   "
51921|NCT02377531|"~     In the current study we aim to determine if early glucose screening and treatment among~     women at high risk for GDM improves perinatal outcome and decreases gestational weight gain.~     Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and~     treatment if necessary and the other half to a standard 24-28 weeks glucose screen.~   "
51922|NCT02377518|"~     Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous~     contrast media in order to study the in vivo ventilation.~      Two different clinical situations will be tested :~        -  Prediction of postoperative pulmonary function for oncologic patients~        -  Detection of Bronchiolitis Obliterans in lung transplant recipients.~   "
51923|NCT02377505|"~     This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for~     treatment of patients with treatment resistant schizophrenia, by means of a random,~     controlled and crossed study.~   "
51924|NCT02377492|"~     The goal of the investigators study is to evaluate the effectiveness of paracervical~     injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The~     investigators will continue to use intramyometrial vasopressin as this has previously been~     shown to be effective. The study will not exceed the safely documented dose of vasopressin.~   "
51925|NCT02377479|"~     The goal of the study is to measure serial hormonal levels in patients undergoing~     clomiphene, letrozole, and a combination clomiphene and letrozole cycle. This information~     may help us to optimize less expensive medications for ovulation induction, reduce the~     number of treatment cycles to achieve a successful pregnancy, and use a medication regimen~     that may result in fewer multiple gestation pregnancies.~   "
51926|NCT02377466|"~     The study's primary objective is to demonstrate the superiority of retosiban to prolong~     pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III,~     randomized, double-blind, parallel-group, multicenter study and will be conducted in~     approximately 900 females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy~     and intact membranes in preterm labor between 24^0/7 and 33^6/7 weeks of gestation. Eligible~     maternal subjects will be randomly assigned in a 1:1 ratio to receive either retosiban IV~     infusion or placebo IV infusion over 48 hours. If not previously administered, antenatal~     corticosteroid treatment should be administered as either (1) two 12-mg doses of~     betamethasone given intramuscularly 24 hours apart or (2) four 6-mg doses of betamethasone~     administered intramuscularly every 12 hours. A single rescue course of antenatal~     corticosteroids is permitted if the antecedent treatment was at least 7 days prior to study~     enrolment. Investigators have discretion to use a standardized regimen of magnesium~     sulphate, as well as intrapartum antibiotic prophylaxis for perinatal group B streptococcal~     infection. Prior to randomization, each subject will be stratified by progesterone treatment~     and gestational age. The progesterone strata will consist of subjects on established~     progesterone therapy or subjects not on established progesterone therapy at Screening. The~     study will comprise 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion~     Assessment, Delivery, Maternal Post-Delivery Assessment, and Neonatal Medical Review. The~     duration of any subject's (maternal or neonatal) participation in the study will be variable~     and dependent on gestational ages (GA) at study entry and the date of delivery.~   "
51927|NCT02377453|"~     A longitudinal study of function and participation in patients with stroke: An integrated~     brain imaging and biomechanical analysis~   "
51928|NCT02377440|"~     The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN~     control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii)~     decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not~     using RAS-related medications~   "
51929|NCT02377427|"~     Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits~     dose proportional and time-independent pharmacokinetics. This pharmacokinetic (PK) and~     pharmacodynamic (PD) study is conducted to support the use of mepolizumab in children aged 6~     to 11 years with severe eosinophilic asthma and characterize the PK/PD of mepolizumab 40~     milligrams (mg) or 100 mg administered subcutaneously depending on participant body weight.~     Participants with bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and~     participants with body weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously~     in upper arm or thigh at Visit 2 (Week 0). Approximately 40 male or femaleparticipants aged~     6 to 11 years will be screened to achieve approximately 28 eligible participants entering~     the treatment phase to allow availability of 20 evaluable participants, with a minimum of~     six participants enrolled in the <40 kg bodyweight group. The total duration of the study~     will be 22 weeks and will include a run-in period of 1-2 weeks, a treatment period of 12~     weeks and a follow-up phase of 8 weeks. A participant will be considered having completed~     the study if the participant completes all phases of the study including the follow-up phase~     (Week 20 [visit 8]).~   "
51930|NCT02377414|"~     This study in healthy, adult Japanese women will characterize the PK, safety and~     tolerability of retosiban at the therapeutic doses planned to be evaluated in Phase 3. The~     PK data will be compared to a sub-set of Caucasian women given the same dose of retosiban.~     This study has two cohorts, cohort 1 will be a double-blind sponsor-open (subjects and~     investigator blinded and sponsor unblinded), randomized, continuous 48 hours (h) infusion~     study in healthy, adult Japanese women of child-bearing potential. Cohort 2 is an open label~     and continuous retosiban 48 h infusion study in Caucasian, adult, healthy women of child~     bearing potential. So, the PK can be compared with those of Japanese women. Approximately 32~     subjects will be enrolled. In cohort 1, approximately 24 subjects will be enrolled and~     randomized to retosiban and placebo (2:1 ratio) to have 18 women with 12 active, 6 placebo~     completed subjects. In Cohort 2, 8 subjects will be enrolled to have 6 competed subjects.~     The total duration of a subject's involvement in this part is anticipated to be up to 6~     weeks (including the 28 day screening period).~   "
51962|NCT02376998|"~     Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute~     transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is~     associated with high rates of morbidity and mortality and in this view endovascular~     treatment seems to be a valid and safer alternative. Aim of this study is to review the~     experience of a single center with endovascular approach for the treatment of acute~     traumatic rupture of descending thoracic aorta~   "
52662|NCT02367859|"~     This pilot clinical trial studies dabrafenib in treating patients with ameloblastoma and a~     specific mutation (change) in the BRAF gene. Dabrafenib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
51931|NCT02377401|"~     Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.~     Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with~     influenza, especially for those patients who may be in greatest need of parenteral influenza~     antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the~     safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600~     mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600~     mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.~     Subjects will be contacted or will return to study center for a follow-up visit, 7 days~     after the last dose or withdrawal from the study. Total number of subjects planned for~     enrollment will be 24 such that approximately 10 subjects complete dosing and critical~     assessments in each dose cohort. The total duration of the study will be approximately 6~     weeks from screening to follow-up.~   "
51932|NCT02377388|"~     Cardiovascular events are the main cause of mortality in diabetic patients ,on the other~     hand,during an acute myocardial infarction(AMI),hyperglycemia increases mortality and is~     related to different pathophysiologic processes.~      More important evidence regarding the effect of glycemic control on AMI patients prognosis~     is contradictory,and the potential benefits of dipeptidyl peptidase-4 inhibitors(DPP4i) in~     this setting is unknown.~      The aim of this study is to assess the presence of pleiotropic effects of saxagliptin(DPP4i)~     and their relationship with glycemic control during the in-hospital phase of AMI.~   "
51933|NCT02377375|"~     When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an~     unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al.,~     2013). The objective of this trial is to investigate whether the use of a micro-electrode~     assisted technique improves targeting precision in DBS at the BNST.~   "
51934|NCT02377362|"~     This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese~     healthy participants after single doses (in Part A), and in participants with type 2~     diabetes mellitus after multiple doses during a 28-day period (Parts B and C).~   "
51935|NCT02377349|"~     The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when~     compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45~     years. Infants born to mothers enrolled in this study will be followed-up in two separate~     clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST:~     048].~   "
51936|NCT02377336|"~     This study will evaluate the effect of GS-6615 in adults with chronic stable angina and~     coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal~     medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a~     Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of~     the Treatment Period, participants will undergo exercise tolerance testing.~   "
51937|NCT02377323|"~     The purpose of this study is to determine whether Rebif has an impact on employment status,~     quality of life and cognition.~   "
51938|NCT02377310|"~     Instantaneous wave-free ratio (iFR™) is a novel non-hyperaemic index of the functional~     significance of a coronary stenosis. Previous studies have shown variable levels of~     correlation with the established hyperaemic index FFR. In addition it has been proposed that~     iFR™ has superior diagnostic accuracy when compared to mean whole cardiac cycle Pd/Pa which~     can also be used to predict FFR.~      We plan to undertake a prospective clinical study in consecutive patients already undergoing~     FFR assessment in the cardiac catheterisation laboratory to compare the ability of iFR™ and~     Pd/Pa (both measured using the proprietary Volcano system) to predict FFR. We will explore~     the level of misclassification of flow limiting disease that results from use of iFR™ and~     resting Pd/Pa employed using either binary cut-off algorithms or in a hybrid decision making~     protocol. We plan to analyse 260 vessels over a 18 month period. Hyperaemia will be induced~     by intravenous adenosine (140 ug/kg/min) administered wherever possible via an antecubital~     vein. Intra-coronary nitrates will also be given in line with the standard care procedure~     for FFR measurement. Final clinical decisions following coronary physiology will be based on~     steady state FFR.~   "
51939|NCT02377297|"~     The aim of this study is to evaluate the survival rate and the cost-effectiveness of~     occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro~     Molar, DFL) in primary molars.~   "
51940|NCT02377284|"~     This pilot study will test the use of visual cues to engage food service workers in~     protecting patrons with food allergies. Food service workers from Philadelphia quick-service~     restaurants were recruited to participate in a survey of attitudes that includes an embedded~     randomized experiment testing an experimental cue (photograph of an allergic child) to~     increase workers' engagement and empathy.~   "
51941|NCT02377271|"~     Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after~     glaucoma in the population aged over 50 years. The visual prognosis of the condition is~     unfavorable in the great majority of cases, with significant effects on the visual field and~     vision. The severity of the unilateral condition is also associated with bilateralization in~     15% at 5 years. There is no effective treatment for the acute phase of the disease or to~     reduce the rate of bilateralization. In this context, it is essential to develop new~     therapeutic strategies in the acute phase of the disease to reduce the anatomical optic~     nerve damage.~   "
51942|NCT02377258|"~     The primary objective of I-CARE is to assess prospectively the presence and the extent of~     safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF~     alone or in combination with thiopurines among IBD patients.~      We will stratify the risk of cancers and serious infections according to IBD phenotype and~     disease activity (clinical, radiologic and endoscopic).~   "
51943|NCT02377245|"~     The investigators created a cohort of patients with juvenile inflammatory rheumatisms with~     the purpose to follow them prospectively, and investigate the tolerance and efficacy of~     immunosuppresive and biological agents.~   "
51963|NCT02376985|"~     To examine whether the occurrence of oral mucositis can be reduced by dental oral management~     in patients by comparing the use of dental oral management through instruction by dental and~     oral surgeons (dental oral management group) and an observation group (brushing instruction~     only group) in a randomized, controlled study in females that are using everolimus for~     estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.~   "
51944|NCT02377232|"~     At the University of Colorado Hospital primary care clinics, only 59% of eligible patients~     are up to date with current colorectal cancer (CRC) screening. This is below the national~     average of 65% and well below the healthy people 2020 goal of 70.5%. Several screening~     methods exist to screen patients for CRC ranging from invasive (i.e., colonoscopy) to less~     invasive (i.e., testing the stool for blood). Although choice between screening methods is~     recommended, patients are not currently offered an unbiased choice and physicians generally~     recommend only colonoscopy. Further, the investigators know from research that choice~     increases screening rates. Unfortunately, many people do not follow through when only~     colonoscopy is offered. However, participants in one study were nearly twice as likely to be~     screened if they were offered a choice between colonoscopy and fecal occult blood testing~     rather than being offered colonoscopy alone. Thus, in this project, the investigators aim to~     examine the feasibility of incorporating a patient decision aid (DA) for patients in CRC~     screening surveillance with the Ambulatory Health Promotion (AHP) using a pre/post design.~     The investigators will answer the following questions: 1) Is it feasible to incorporate a DA~     in the AHP protocol?; 2) Is it feasible to incorporate mailing patients a stool blood test?;~     3) Does the DA change CRC screening decision quality, using proxy measures such as knowledge~     and intent; and 4) Does the DA change the proportion of participants that complete a CRC~     screening test? To answer these questions the investigators will compare survey responses~     and CRC test type completed between two AHP CRC surveillance patients groups - those that~     received usual care versus those that received the DA.~   "
51945|NCT02377219|"~     Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as~     its free and conjugated forms in blood and urine) and embryo implantation rate (measured as~     the ratio between the number of gestational sacs and the number of transferred embryos)~     after assisted reproductive technology. In order to reduce the confusion factors, the~     population study is limited to young women (aged 28 to 34), with regular menstrual cycles~     and without any medical event that could affect the implantation process~   "
51946|NCT02377206|"~     The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease~     subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its~     relationship with the kinetics of cognitive decline over a 24-month follow-up period (as~     assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and~     Mini-Mental State Examination (MMSE) scores).~   "
51947|NCT02377193|"~     Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte~     globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies~     (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially~     in highly sensitized patients. Both induction therapy regimens have a different tolerance~     profile. Infections and haematological side-effects are more frequently reported in patients~     receiving ATG.~      The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo~     sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor~     specific antibodies (DSAs) detected by Luminex.~   "
51948|NCT02377180|"~     There is currently no specific diagnostic test for primary muscular pain. The present study~     investigates whether selective blockade of the suprascapular nerve can effectively abolish~     experimental pain arising from the supraspinatus muscle. Experimental muscle pain is induced~     by intramuscular injection of capsaicin, an alkaloid from red chili peppers. The study~     consists of three parts:~        1. to describe the development, time course and intensity of capsaicin-induced muscle pain~        2. to evaluate the effectiveness of suprascapular nerve block against capsaicin-induced~          muscle pain~        3. to compare suprascapular nerve block and direct intramuscular local anesthetic~          infiltration for their effectiveness in capsaicin-induced muscle pain~   "
51949|NCT02377167|"~     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,~     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal~     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal~     tube below the larynx. This so called tracheostomy might be associated with advantages such~     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth~     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for~     tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early~     tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may~     also have improved survival and long-term functional outcomes, but a large, multicenter~     clinical trial is needed to confirm these findings.~   "
51950|NCT02377154|"~     The purpose of this study is to determine if the keratometric functions of the VERION Image~     Guided System are comparable to those of established keratometric devices (IOLMaster 500,~     Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical~     consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image~     Guided System.~      In addition the comfort and duration of examination in the different devices is evaluated.~   "
51951|NCT02377141|"~     Gastro-oesophageal varices (swollen veins in the gullet and stomach) are present in 50% of~     patients with liver cirrhosis and are its most serious complication as their rupture results~     in potentially life threatening bleeding. Bleeding from these veins occurs in up to one~     third of patients with varices. This is associated with 20% mortality at 6 weeks.~      In the event of bleeding from these veins the current UK guidelines recommend certain drugs~     followed by early endoscopic treatment with variceal band ligation (rubber bands placed over~     the veins to stop them bleeding). The use of a shunt inside the liver (TIPSS transjugular~     intrahepatic portosystemic shunt) is largely reserved for cases of uncontrolled bleeding~     from these swollen veins. A recent randomised multicenter study carried out by Garcia Pagan~     and colleagues reported improved survival with early TIPSS in patients with bleeding from~     these swollen veins in advanced liver disease. From these guideline international guidelines~     now recommend consideration of early TIPSS for all high-risk patients presenting with~     variceal bleeding. This practice clearly has significant cost implications. To validate the~     findings a further randomised control trial is needed.~      This is a multi-center parallel-group randomized controlled trial. Both hospitals taking~     part in the trial will have a TIPSS service. Patients who consent to enter the trial will be~     randomized to either: (1) Endoscopic treatment (standard care) or (2) early TIPSS.~      Potential participants will be all patients with a diagnosis of liver cirrhosis presenting~     with an acute variceal bleed to a participating hospital who do not fulfill an exclusion~     criteria. All causes of cirrhosis will be included.~      Participants will be reviewed during their regular hepatology clinic appointments at their~     respective hospitals on 3 occasions over a one-year period.~   "
51964|NCT02376972|"~     THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF~     RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS~   "
53996|NCT02350348|"~     To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive~     factors that can be responsible for poor outcome.~   "
51952|NCT02377128|"~     The aforementioned study was designed to evaluate short term ovarian reserve as assessed by~     anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation,~     as part of cesarean sections performed in women requesting future sterilization. The~     investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at~     the investigators' institution, 2 of which request sterilization (allocated to tubal~     ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups~     will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks~     following. This is preformed in light of validated data offering better sterilization and~     possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been~     proved to be just as safe as tubal ligation. This will be performed as a randomized~     controlled trial.~   "
51953|NCT02377115|"~     Postoperative delirium (PD) - a temporary state of confusion - is a frequent complication of~     surgery, which most commonly occurs in elderly patients. A computer program that may assist~     in preoperative screening for postoperative delirium was developed at the University~     Hospital Basel in 2014. This study will be conducted with the aim to investigate if the~     computer program may assess the risk of a patient to develop PD.~   "
51954|NCT02377102|"~     Purpose: For the target population of adult patients with end stage osteoarthritis, this~     randomized clinical trial will be used to evaluate the benefit of three months of physical~     therapy compared to no treatment in patients indicated for total knee arthroplasty.~      Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for~     total knee arthroplasty.~      Procedures: Patients will be randomized to either receive physical therapy or no treatment.~     They will be scheduled to return in 3 months for discussion of operative versus continued~     nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS~     (Patient Reported Outcome Measurement Information System) score and prevention of surgery.~   "
51955|NCT02377089|"~     The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS)~     to examine the efficacy of TNS as a new treatment for PTSD in veterans. Recruitment will~     take place at the PTSD Outpatient Clinic at the VA GLA. Study participants will be asked to~     complete, at most, 9 assessments/questionnaires regarding their PTSD symptoms and quality of~     life, use the TNS device every night for 8 hours, log their use of the device, and attend~     weekly visits to monitor safety and complete assessments. Each subject will be asked to~     attend 8 visits over the course of 8 weeks. Subjects who receives the sham-controlled~     treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to~     examine symptom improvements.~      Enrollment and subject-related procedures are projected to take approximately 36 months.~     Preparations for clinical trial, clinical trial/study procedures and data analysis will~     occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration~     of this project is approximately 4 years.~   "
51956|NCT02377076|"~     Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of~     type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and~     increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of~     dietary calcium supplementation in permeability and intestinal microbiota in overweight type~     2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study.~     Patients (n=20) with low habitual calcium intake will be allocated in control group~     (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be~     prescribed containing 800 mg of calcium from dietary sources / day. During intervention~     period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700~     mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body~     composition (total body fat and fat free mass) and anthropometric measures (waist~     circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal~     diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity~     level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone,~     25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin,~     HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide,~     inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical~     analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008,~     version 17.0). Parametric or non-parametric tests will be applied, according to the~     distribution of variables (level of statistical significance of 5%).~   "
51957|NCT02377063|"~     This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects~     will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool~     samples will be collected at baseline, day 4 and day 17. The purpose of the study is to~     determine the effects of fruit/vegetable supplementation on colonic flora.~   "
51958|NCT02377050|"~     The primary hypothesis is that preterm infants who are less than or equal to 32 weeks~     gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a~     feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160~     ml/kg/day~   "
51959|NCT02377037|"~     There is already a lot of scientific evidence supporting the benefits of public health~     recommendations regarding physical activity (the accumulation of at least 150 minutes of at~     least moderate intensity physical activity per week). However, these 30 daily minutes~     represent only about 3% of the waking period. Recent data suggest that most of the~     population spends on average 8-9 hours / day of sedentary behavior (SB). SB is characterized~     by any activity with a metabolic cost (MC) below 1.5 METs, mainly actions in the sitting~     position. In fact, there is evidence that the more time spent sitting higher the risk of~     disease and mortality, with sitting directly associated with diseases such as type II~     diabetes, cardiovascular diseases and even cancer. The average life expectancy may increase~     by ~ 2 years if the investigators reduce sitting about 3h/ day. Additionally, how people~     accumulate sitting time seems to be a major factor, with prolonged sitting associated with a~     higher risk of disease. Short-term experimental studies indicate that sedentary lifestyles~     affect energy balance enhancing weight gain. While there is some research regarding the MC~     associated with sitting and standing behaviors, the results are contradictory. Besides~     these conflicting results, the impact of transitions between these two types of behavior and~     how these transitions can contribute to MC increase have never been investigated.~      Our hypothesis is that, in both men and women, the simple replacement of sitting for~     standing may not substantially increase MC, but instead, the largest contribution may~     reside on the transitions between these two states of behavior. Therefore, the investigators~     will perform a study with the following purposes:~      Examine MC and HR associated with sitting, standing, and transitions between these two~     types of behavior in adults of both gender, apparently healthy with variable body~     composition profiles.~   "
51960|NCT02377024|"~     The objective of this study is to demonstrate the cognitive enhancement effect and safety of~     Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention,~     and psychomotor speed) and the latest brain imaging methods for healthy adults suffering~     subjective cognitive impairment.~   "
51965|NCT02376959|"~     Background: The use of alternative therapies in medicine has been increasing worldwide.~     Among these therapies are energy therapies such as Reiki , Johrei, and Spiritist passe.~     Experimental studies have confirmed the action of the energy therapies in animal models or~     in cell cultures. These therapies appear to have positive effects, particularly in the~     reduction of anxiety and pain. Objective: To evaluate the effectiveness of the passe~     energy therapy in reducing anxiety in subjects presenting anxiety symptoms after 8 weeks of~     study. Methods: The recruited volunteers will be randomized into two groups: the Control~     Group (application of 8 passe simulation sessions by people without spiritualist training~     at the same time and in the same environment as the treatment group) and the Treatment Group~     (application of 8 sessions of passe by spiritists with over 2 years of experience in~     controlled environments for the same period as the control group). The sample will consist~     of 60 patients selected by interviews with the expectation of a 20% reduction of anxiety in~     the control group and 60% in the treatment group with alpha of 0.05 and beta of 0.8.~     Results: Using the STAI scale for evaluation, the reduction in anxiety is expected to be~     significantly higher in the treatment group than in the control group. The investigators~     expect approximately 20-30% reduction of the anxiety in the control group by the placebo~     effect. Other objectives to be assessed are quality of life, spirituality, and depression by~     specific standardized scales (WHOQOL-BREF, DUREL, and BECK).~   "
51966|NCT02376946|"~     This study is a prospective, randomized, double-blinded, controlled, clinical trial that~     evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and~     pain after extraction of impacted third molars. The study group will be comprised of~     subjects that will receive PEMF Actiband treatment for postoperative management of pain and~     edema. The control group will be comprised of the subjects that will receive a placebo patch~     as treatment for postoperative management of pain and edema.~      Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until~     60 qualified subjects have been recruited. Eligibility criteria will be based on the~     standards for conducting oral surgery procedures on third molar extractions, in addition to~     safety considerations and contraindications for the Actiband and other agents to be used.~     Moreover, the selected subjects will have the same surgical difficulty and surgical trauma~     anticipated standardized by classification system of impacted third molars. All inclusion~     and exclusion criteria will be thoroughly explained in the relevant section of this~     proposal. Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale,~     respectively. Different measurements will be obtained immediately before the surgery and in~     standard periodic intervals as described in the Materials and Methods section of the~     proposal. Any difference in postoperative edema, pain, and site responsible for request of~     rescue pain medication will be compared and analyzed between the two groups.~   "
51967|NCT02376933|"~     Vertebral augmentation with radiotherapy to increase the functional status and quality of~     life for patients with vertebral body metastatic cancers.~   "
51968|NCT02376920|"~     Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every~     year. Nearly half of these experience spread of their cancer outside the eye. The~     DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or~     high risk (class 2) of spreading. This study is being done to collect information about how~     physicians are using the DecisionDx-UM results to design individual treatment plans. It will~     also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.~   "
51969|NCT02376907|"~     This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage~     according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric~     outlet obstruction (GOO) and the location of GOO.~   "
51970|NCT02376894|"~     The aim of this study is to examine the prevalence, severity, impacts and managements of CRF~     among Taiwanese cancer patients.~   "
51971|NCT02376881|"~     Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally~     optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin~     (EPO) has recently emerged as a drug that may help retinal ganglion cell loss and improve~     optic nerve function in some acquired types of optic neuropathy including traumatic optic~     neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer~     some protection to the optic nerve and retina when they are injured and apoptosis process~     starts in retinal ganglion cells. The standard treatments of methanol poisoning are~     reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist~     agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However,~     after established optic neuropathy and visual loss there is little chance, if any, for~     visual recovery and no definitive treatment exist for treatment in these cases. The~     investigators recently reported the investigators preliminary results on 16 cases with~     methanol poisoning and found a beneficial effect of systemic erythropoietin in methanol~     associated optic neuropathy. Now, the investigators aim to investigate the effect of this~     agent in a clinical trial.~      The purpose of this study is to determine if EPO could improves optic nerve function and~     help patients to improve visual recovery after methanol poisoning. Primary outcome measure~     would be best-corrected visual function and secondary outcome measure is ocular coherence~     tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this~     study could be very valuable in formulating an evidence-based management of Methanol~     Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the~     practice on management of methanol poisoning . Also it could provide valuable data for~     neuroprotective effects of erythropoietin specifically in neuroscience and ophthalmology.~      The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter~     blinded mono-center pilot trial with two parallel groups and a primary endpoint of best~     corrected visual acuity during 120 days after enrollment into treatment groups.~      All patients with methanol poisoning referred to Farabi hospital will be examined and~     evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent~     pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of~     anterior segment and fundus exam with 78 D lens.~   "
51972|NCT02376868|"~     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber~     Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the~     Maestro and iVue OCT devices.~   "
51973|NCT02376855|"~     The purpose of this study is to evaluate the implementation of an electronic consultation~     model for specialty services (eConsults) to improve quality of care and reduce health system~     costs. An eConsult is a non-face-to-face consultation between a primary care provider and a~     specialist that takes place via secure messaging.~   "
51974|NCT02376842|"~     The investigators hypothesize that implementing an electronic health record-based early~     warning system for severe infections (severe sepsis) will decrease the time to antibiotic~     order. The study will consist of an algorithm which will monitor lab values, vital signs,~     and nursing documentation for signs of severe sepsis. When these criteria are met, an alert~     will be delivered via the electronic health record to a nurse and doctor and simultaneously~     an alert via pager to another nurse. The investigators plan to randomize which patients will~     generate these alerts and analyze the data after collecting information for approximately 6~     months which will be sufficient to detect a 10% difference in the two patient groups.~   "
51976|NCT02376816|"~     The proposed phase I clinical trial is a pilot study to evaluate safety and biological~     activity of the rAAVrh74.MCK.micro-Dystrophin vector administered by an intramuscular route.~     This study will evaluated the micro-Dystrophin vector as a potential dystrophin replacement~     mechanism for Duchenne Muscular Dystrophy. Two cohorts will undergo gene transfer in a~     standard three-six dose escalation scheme to establish maximum tolerated dose (MTD) using~     toxicity. A minimum of three subjects will be enrolled into each cohort. The first cohort~     will receive a total dose of 3E11 vg. The second cohort will receive 1E12 vg total dose.~   "
51977|NCT02376803|"~     Warfarin is an anticoagulant medication that is highly effective at preventing clotting~     disorders but which has a narrow therapeutic window. If warfarin is under effective patients~     are at risk of stroke, if it is over effective patients are at risk of bleeding~     complications. Physicians routinely and regularly measure a blood test (called the INR)~     that determines the effectiveness of warfarin and have a range of test values (the~     therapeutic range) in which they try to keep the patient. By convention warfarin is taken~     at dinnertime, however this is the same time of day that highly variable consumption of~     dietary vitamin K occurs (found largely in green leafy vegetables) and vitamin K alters the~     effectiveness of warfarin. Given vitamin K has a very short half-life (i.e. it is only~     active for a short period of time after it is ingested) it may make more sense to take~     warfarin in the morning (when very little vitamin K is ingested) to produce a more~     consistent drug effect. The purpose of this study is to determine whether switching current~     warfarin users from evening to morning dosing decreases time spent outside the therapeutic~     INR range.~   "
51978|NCT02376790|"~     The purpose of this study is to learn more about the role of etanercept alone or in~     combination with methotrexate on disease activity in subjects with psoriatic arthritis.~      To do this, etanercept alone will be compared to methotrexate alone or to combination~     etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an~     individual subject.~      Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of~     receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the~     subject nor the study doctor can choose the group to which the subject will be randomized~     into. Subjects will take one study medication by injection under their skin and a second~     medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates~     the subject and determines that their condition has not improved, the subject may qualify to~     receive etanercept plus methotrexate.~   "
51979|NCT02376777|"~     Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K~     antagonist (VKA) in real practice remain uncertain.~      The few existing ambulatory studies did not answer all NOAC specific issues, such as~     prescription habits and motives, patients characteristics, biological monitoring, as well as~     the occurrence of major and minor thromboembolic events, especially in France where warfarin~     is less frequently prescribed.~      Therefore, in order to describe clinical and follow up characteristics of patients receiving~     oral anticoagulants, the investigators will set up a national prospective cohort to compare~     the occurrence of thromboembolic events between VKA and NOAC in primary care.~   "
51980|NCT02376764|"~     This study aims to deepen the investigators knowledge of Post Thrombotic Syndrome and MMPs~     (and other related molecules such as TIMPS, NGAL and cytokines) to find a predictive~     molecular system to better classify the risk of patients to develop a PTS after a DVT~     episode, in order to monitorate more strictly the patients at high risk for developing this~     complication.~   "
51981|NCT02376751|"~     This is an open-label, multicenter expanded access protocol to allow patients with a~     confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US),~     access to sebelipase alfa (recombinant lysosomal acid lipase [rhLAL]) until commercial~     product is available.~      Patients enrolled in the expanded access protocol will receive 1 mg/kg intravenous infusions~     of sebelipase alfa every other week.~   "
51982|NCT02376738|"~     This study aims to evaluate the role of leukocyte activation in coronary artery disease~   "
51983|NCT02376725|"~     The purpose of this study is to determine if phacoemulsification with intraocular lens~     implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling~     intraocular pressure in subjects with primary angle closure.~   "
51984|NCT02376712|"~     The study aims to evaluate the diagnostic value of urinary indices in differentiating~     pre-renal and renal acute kidney injury among critically ill patients.~   "
51985|NCT02376699|"~     This study will examine the safety profile of SEA-CD40. The study will test increasing doses~     of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find~     the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable~     side effects. Different dose regimens may also be evaluated to see if more SEA-CD40 can be~     given within a treatment cycle while maintaining an acceptable safety profile. The~     pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of~     SEA-CD40 will also be evaluated.~   "
51986|NCT02376686|"~     The purpose of this study is to determine whether music hearing in the evening before going~     to sleep can improve sleep quality, depressive symptoms and quality of life in patients with~     affective disorders.~   "
51987|NCT02376673|"~     This randomized controlled trial compares a specially-designed children's book to standard~     brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk~     in a high-risk population of young, first-time mothers enrolled in a home visitation~     program. Roughly half of the mothers will receive safe sleep education via the book, the~     other half via brochures, during prescribed home visits. Our study will assess differences~     in safe sleep knowledge, adherence to recommendations, satisfaction with materials used, and~     attitudes towards reading with their baby. Our hypothesis is that these will be higher in~     the group receiving the book, due to simpler language, appealing illustrations, emotional~     connection, and repeated exposures via shared reading.~   "
51988|NCT02376660|"~     A randomized control trial to assess the effect of oats on lipid profile of mildly~     hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g /~     day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams~     of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks.~     In total 3 assessment visits of the subjects planned for the study period.~   "
63179|NCT02230306|"~     The purpose of this study is to evaluate the effectiveness of the combination of vemurafenib~     with cobimetinib in patients with active melanoma brain metastases.~   "
51990|NCT02376634|"~     The purpose of this randomized controlled study is to test the feasibility of clinical~     hypnotherapy as a perioperative intervention for the reduction of pre-operative anxiety,~     post-operative pain, and other-related symptoms (nausea, vomiting, spasms, length of stay,~     self mastery) in children undergoing scoliosis repair or Nuss procedure.~   "
51991|NCT02376621|"~     The study will evaluate the bioavailability of omega-3 based dietary supplements under~     fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment~     periods. The order of treatments will be in accordance with the randomisation schedule.There~     will be a minimum of 4 treatment-free days between each treatment period. On each dosing~     occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of~     dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.~   "
51992|NCT02376608|"~     The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum~     PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride~     containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.~   "
51993|NCT02376595|"~     The purpose of this study is characterize the dose-effect relationship of rocuronium bromide~     at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic~     (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the~     neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the~     adductor pollicis muscle.~   "
51994|NCT02376582|"~     The primary objective of the proposed phase I trial is to evaluate the safety and~     tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123~     and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and~     have shown to be safe and well tolerated, this is the first time the combination regimen is~     being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The~     secondary objective of the trial is to evaluate the effect of S. mansoni infection on the~     immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen.~     Successful vaccination against most viruses requires efficient Th1 response. There is~     evidence that helminth infections skew the host immune system of human and animals to~     T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that~     helminth infected populations may not generate the desired immune responses to vaccines~     designed to drive Th1-type and cytotoxic T-cell responses.~      Furthermore, the influence of helminth infections on the development of protective antibody~     responses remains unclear. Limited data in animal models suggests that worm infections~     reduced efficacy of vaccines.~      The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a~     vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine~     (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV~     vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and~     immune responses to HIV vaccines.~   "
51995|NCT02376569|"~     This study intends to collect self-reported information with multiple surveys about~     lifestyle habits, food and drink, state of mind (happy, sad, etc.) and traits (decision~     making, general personality, etc.) The purpose of this study is to understand relationships~     between self-reported information, game performance, and passive physiology measures~     throughout a daily cycle.~   "
51996|NCT02376556|"~     The investigators aim to assess the effect of blepharoplasty with or without muller muscle~     resection on the symptoms of dry eye syndrome. this will be an observational study in which~     patients undergoing the aforementioned surgeries will be followed up and monitored for dry~     eye symptoms.~   "
51997|NCT02376543|"~     Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in~     Pancreatic Fiducial Placement To Treat Pancreatic Cancer~   "
51998|NCT02376530|"~     The purpose of the research is to examine the association between price changes, nutrient~     profiling, and grocery food purchases among household grocery shoppers.~   "
51999|NCT02376517|"~     The purpose of this study is to test the effectiveness of a sun protection education program~     for children of all ethnic and racial backgrounds. Practicing sun protection in childhood~     can reduce the likelihood of developing skin cancer as an adult. The educational program~     consists of a read-along book in English and Spanish for the child to read with the parent~     or caregiver, text message reminders to practice sun protection, and a sun protective swim~     shirt for the child.~   "
52000|NCT02376504|"~     The primary objective of this project is to determine the effects of decreasing sedentary~     behavior at work by at least 3hrs/day using treadmill (walking and standing) and~     sit-to-stand (standing only) workstations on the health of overweight office workers.~   "
52001|NCT02376491|"~     This trial will compare innovating stimulation parameters, intermittent Theta Burst~     Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral~     prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both~     treatment conditions. The study seeks to determine if there is a superiority in therapeutic~     efficacy with iTBS protocol compared to conventional one.~   "
52002|NCT02376478|"~     In this prospective, open, controlled, cross-sectional observational study patients with~     psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-,~     folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease~     were included.~      Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk~     (HPV6) and high-risk HPV (HPV16, HPV18) were determined.~   "
52003|NCT02376465|"~     To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a~     bowel preparation prior to colonoscopy in adult patients.~   "
52004|NCT02376452|"~     This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with~     FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line~     setting.~   "
52005|NCT02376439|"~     This research studies the energy balance behaviors (usual eating, physical activity,~     sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean~     the other is overweight).~   "
52006|NCT02376426|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult~     participants.~   "
53296|NCT02359526|"~     To provide treating physicians with experience with ILUVIEN as well as monitoring its safety~     (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged~     insufficiently responsive to available therapies.~   "
52007|NCT02376413|"~     Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast~     cancer patients. There are evidences indicating that oncoplastic-BCS (displacement~     technique) could improve cosmetic outcomes and/or quality of life, and has similar~     oncological safety as traditional BCS does. However, there are no prospective trial~     comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological~     safety. In this study, the investigators are going to address this issue by assigning~     patients into traditional and oncoplastic-BCS group, based on their preference.~   "
52008|NCT02376400|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult~     participants.~   "
52009|NCT02376387|"~     The proposed research will provide evidence-based strategies for the evaluation and~     acceptance of donor hearts for transplantation. This is relevant to public health because~     judicious expansion of donor hearts used for transplantation will make this life-saving~     procedure available to a larger number of patients living with end-stage heart disease.~   "
52010|NCT02376374|"~     The investigators propose to study both inter- and intra-household Oral Polio Vaccine (OPV)~     transmission in a primarily inactivated-polio vaccine (IPV)-vaccinated community in Mexico.~     The investigators will enroll 3 distinct clusters of households in a municipality in~     Orizaba, Veracruz, Mexico prior to the February 2015 National Immunization Week (NIW.) These~     clusters will be physically separate from one another and differ only in the proportion of~     OPV-eligible children who will receive OPV during the February 2015 NIW (10%, 30% and 70%~     vaccinated.) The investigators will look at inter-household and intra-household~     transmission. The investigators will then determine if epidemiologic (i.e.: degree of~     contact), anthropometric (i.e.: nutritional status) or clinical covariates (i.e.: IPV/OPV~     immunization history) are associated with intra-household transmission.~   "
52011|NCT02376361|"~     The purpose of the study is to learn if monitoring dialysis access blood flow during~     dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or~     reduce) the development of dialysis access thrombosis (clotting).~      Investigators would like to study if monitoring with a specific technique called ultrasound~     dilution technique can help prevent problems with access when compared to what is the~     current standard of care for patients.~   "
52012|NCT02376348|"~     Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in~     2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's~     Maternal and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary~     medical male circumcision (VMMC) program which has circumcised over 110,000 males in Njombe~     and Iringa regions by June 2012. In line with the national strategy, the target age for the~     program was 10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need~     to increase the proportion of older men (aged 20 years and above) who become circumcised, to~     have greatest impact on the HIV epidemic.~   "
52013|NCT02376335|"~     Primary Biliary Cirrhosis (PBC) is a liver disease that predominantly affects females, can~     present for the first time at any age and which develops over many years. It is caused by~     the immune system attacking the body's own tissues. People with PBC frequently experience~     profound fatigue or tiredness which they liken to their batteries running down and~     although people still want to undertake normal activities they often lack the energy to be~     able to do them. This reduces quality of life, makes it difficult for people to work and can~     end up with them becoming isolated in the community. At present the investigators have no~     treatment for fatigue in PBC. Finding a treatment for fatigue in PBC is one of the highest~     research priorities identified by patient groups.~      The aim of this study is to undertake a clinical trial to examine the effects of a treatment~     (Rituximab) on severe fatigue in PBC to help us understand whether this will be a~     potentially useful treatment. The information that this will give us about how energy~     generation changes in patients with PBC with and without the treatment will also help us to~     develop new treatments for fatigue in other diseases. The study has the potential to improve~     the quality of life of many patients with PBC, for whom there is currently no hope of~     improvement.~      The investigators will perform a randomised controlled study of Rituximab therapy in PBC~     compared to placebo (1:1 ratio).~      The study will be performed in a specialised clinical research environment at Clinical~     Research Facility Royal Victoria Infirmary. The investigators have, for many years, worked~     closely with PBC patient groups to focus on the problems that are important to our patients.~     This study is fully supported by Liver North, a liver disease charity and patient support~     group.~      The study will take place over one year and will involve between 9 and 20 visits although a~     number of these will be telephone visits. Blood tests and quality of life questionnaires~     will be performed at the start of the study and after three, six, nine and twelve months. At~     baseline and 12 weeks follow up physical activity will be monitored using monitors, and an~     exercise test and MRI scan will be performed.~   "
52014|NCT02376322|"~     Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients~     with complicated bone metastases and have a low potential for severe treatment-related~     toxicities. There is a clear need for hypofractionated schedules in the complicated bone~     metastases population, especially when considering the overarching aim of palliative~     radiotherapy and the clinical features of this patient population. As well, current research~     examining hypofractionated approaches in bone metastases patients with impending or~     pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly~     scarce.~   "
52015|NCT02376309|"~     A decrease in muscle mass can have a profound impact on quality of life, as it can lead to~     decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this~     study we investigate whether ingesting leucine or getting a ND injection will reduce the~     loss of muscle mass and strength.~   "
52016|NCT02376296|"~     In this observational study, blood samples for pharmacokinetic (PK) testing will be~     collected from subjects with metastatic prostate cancer during their treatment with~     docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel~     exposure levels, determined as an area under the curve (AUC), will be retrospectively~     correlated with reports of toxicity, tumor response, quality of life, time to disease~     progression and overall survival to provide guidance on what the appropriate target range~     for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel~     therapy for their disease.~   "
52024|NCT02376192|"~     This is a study of pregnant women undergoing a cesarean delivery. It will compare their~     microcirculation before and after the anesthetic. Microcirculation means blood flow to the~     extremely small blood vessels in the body. It will also look at the differences in~     microcirculation of participants who receive an infusion of phenylephrine compared to~     participants who don't. The investigators hypothesize that spinal anesthesia will reduce the~     vascular density and proportion of perfused vessels.~   "
52579|NCT02368938|"~     The Northern Shanghai Study is a prospective community-based study, which is aimed to~     investigate the prognostic factors, including conventional cardiovascular risk factors and~     asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000~     elderly Chinese.~   "
52017|NCT02376283|"~     Major heart attacks are caused by a numerous factors, including sudden clot formation in a~     coronary artery leading to a blockage and heart muscle death. The clots are largely made of~     sticky clotting blood cells (platelets). A patient having a major heart attack is treated~     with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon~     are used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep~     the artery open.~      Aspirin, and one of two other antiplatelet drugs (prasugrel or ticagrelor) are given prior~     to PPCI to prevent further clots formation. Both antiplatelet drugs are taken in tablet form~     and in healthy stable patients these drugs take at least 30 min to 2 hours to exert an~     adequate effect. Often PPCI procedures are performed well within this timescale. It is~     possible that having a major heart attack limits the bodies ability to absorb the drugs~     also.~      In this study, patients with major or minor heart attacks will be given either prasugrel or~     ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample~     will be taken at first balloon inflation to reopen the blocked artery, then after 20~     minutes, 60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected~     to a variety of tests to determine antiplatelet drug activity.~      This study will identify which of the two agents used are working effectively during PPCI,~     given the very short timescales involved. It will also show if patients with major heart~     attacks absorb the drugs less well than patients with less severe heart attacks. In the~     future it might be that an intravenous agent will be more valuable in the setting of PPCI.~   "
52018|NCT02376270|"~     The population is aging worldwide, which requires more attention to health needs and leads~     to a dramatic increase in health care costs. Prevention or delay of onset of disorders~     associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have~     beneficial effects on gut health parameters, i.e. intestinal barrier function, immune~     function and microbial composition. As intestinal barrier function may be compromised in the~     elderly we will investigate whether the effects of pectin on selected parameters of gut~     health differ between young vs. older individuals. The primary objective of this study is to~     investigate the effects of aging on pectin-induced changes in intestinal permeability.~     Furthermore, this study has seven secondary objectives. This study conforms to a randomized,~     double-blind and placebo-controlled design including two parallel arms.The study population~     consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30~     kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A~     second group will receive 7.5 grams of placebo supplements twice daily for four weeks.~     Before and after the supplementation period, several measurements will take place. The main~     study parameter is the change in urinary sugar excretion ratio before and after the~     intervention period.~   "
52019|NCT02376257|"~     Despite advances in both pharmacotherapy and psychotherapy for major depression,~     non-response and partial-response remain relatively common outcomes, motivating the search~     for new treatments. This study is concerned with the development of one such novel~     treatment, the augmentation of exposure-based cognitive-behavior therapy (CBT) with~     d-cycloserine (DCS).~   "
52020|NCT02376244|"~     Cardiac rehabilitation is a program designed to help patients regain good health through~     lifestyle change after a heart attack, heart surgery or other heart problems. Patients will~     take part in exercise sessions and education lessons, tailored to meet their personal needs.~     The exercise training component of cardiac rehabilitation may be delivered as intervals of~     short intense sessions (also known as high intensity intervals) or the current standard care~     of longer but less intense sessions (moderate intense intervals). Both exercises have been~     shown to increase fitness levels and also prevent future risk of heart disease.~      The purpose of this study is to determine the efficacy and safety of high intensity interval~     exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or~     recovering from a heart attack, in comparison to current standard of moderate intensity~     exercise training in terms of their physical fitness and psychological well-being.~   "
52021|NCT02376231|"~     Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of~     pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix)~     and any other tissues involved with cancer. Several studies worldwide have reported that~     women survive longer and enjoy a longer disease free interval before their disease returns~     if all visible disease is removed at the time of their surgery. Achieving this is not easy~     and often there is widespread disease and the surgeons are unable to remove every tumour~     nodule present as it is attached to the surface of the bowel, diaphragm and other important~     Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is~     commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is~     heated, it partially or wholly ionizes resulting in high energy particles like ions,~     electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine~     jet of neutral argon plasma from the handpiece that has been shown to have the ability to~     vaporise nodules close to sensitive organs like the bowel. It may offer the potential to~     treat the tumour nodules close to sensitive areas like the bowel. There have been no studies~     exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be~     used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of~     tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation~     and ablation. It is similar to conventional surgical devices that are routinely used (called~     diathermy) to achieve these effects. The PJ however is slightly different in that it may~     also be used on tissue to vaporise tumour nodules in women with ovarian cancer during~     surgery though the full extent of this role remains unclear.~   "
52022|NCT02376218|"~     It is common practice to leave a chest drainage catheter after lung surgical resections to~     manage air leaks. The air leakage will usually stop in the initial postoperative days, but~     in a few patients, it will last for a longer period of time, preventing the removal of the~     chest tube that can lead to patient discomfort, increased likelihood to develop~     postoperative complications and longer length of hospital stay. Pleurodesis is an effective~     method to address postoperative air leak which consists in injecting an irritating solution~     into the chest cavity. This is not performed regularly after lung resections for different~     reasons including associated pain, costs, and fear of infections. Pleurodesis with~     hyperosmolar glucose solution have been used for years with good results in some Asian~     countries because of its simplicity and low cost. Its effectiveness for pleurodesis has been~     reported in cases of spontaneous pneumothorax and chylothorax, but its efficiency to stop~     air leaks in the postoperative period remains to be defined.~   "
52023|NCT02376205|"~     The main objective of this study is to analyze the effects of local anesthetic application~     into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or~     occurrence rates in patients undergoing anterior cervical discectomy and fusion.~   "
53309|NCT02359357|"~     To determine the safety and tolerability of single and multiple escalating doses of FDL169~     in healthy male subjects.~   "
52025|NCT02376179|"~     We have devised a simple method to continuously measure the endotracheal tube cuff pressure~     (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the~     operating room to monitor arterial or central venous pressures. We have previously confirmed~     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable~     agreement of the IPMS readings with the values obtained from a standard manometer (gold~     standard). In the current study, we will prospectively evaluate the relationship between the~     patient's head position and CP in patients undergoing otolaryngological surgery and also~     measure the oxygen and nitrous oxide saturation in the oropharynx.~   "
52026|NCT02376166|"~     Clinical trials are critical to informing the care of patients with cancer. However, only~     3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major~     implications with regards to the pace of progress, the cost of clinical cancer research, and~     the generalizability of results. The investigators have recently shown in an analysis of~     7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of~     cancer clinical trials fail to complete enrollment at all; the most often cited reason was~     poor accrual.~      Prior research has identified barriers to cancer clinical trial accrual that can be~     generally categorized in the domains of availability, awareness, and acceptance. Much~     attention has been paid to the barriers involvement awareness and acceptance - however,~     trial availability is likely a rate limiting step. This pilot study is the first in a~     series of planned steps to attempt to shift the current paradigm of bringing patients to~     trials to bringing trials to patients. With the integration of telemedicine visits, the~     investigators aim to decrease the burden of participation for patients, begin to address~     geographic barriers, and ultimately improve trial accrual. In this study, men with~     biochemically recurrent prostate cancer (a rising PSA after definitive local therapy) will~     receive the antidiabetic drug, metformin. Patients will require a single on-site visit for~     study enrollment. The remainder of the 6 month study will be conducted via a HIPPA secure~     telemonitoring system (monthly visits conducted via telemedicine with tablet computers~     provided to each patients).~   "
52027|NCT02376153|"~     This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier~     System device reduces the incidence of surgical site infection after total hip replacement,~     acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.~   "
52028|NCT02376140|"~     Sorghum is the primary source of food for more than 300 million people in arid and semi-arid~     regions of Africa. The grain is one of the few crops that grow well in arid climates, but~     has a low content in most essential nutrients and is difficult to digest. The African~     Bio-fortified Sorghum (ABS) Project, a consortium of nine institutions led by Africa Harvest~     Biotech Foundation International, is working to develop new varieties of sorghum that are~     easier to digest and contain lower levels of phytates to improve the bioavailability of~     micronutrients.~      In order to determine their target levels, the ABS project needs reliable information on~     current levels of micronutrient deficiency and consumption patterns of sorghum and nutrients~     of interest, e.g. iron, zinc, and vitamin A in women and preschool children, which are not~     currently available in Burkina Faso.~      A background nutrition survey among children and women, comprised of two rounds, one in the~     lean season (July - August) and one in the harvest season (November - January), has been~     conducted to provide quantitative estimates of sorghum, vitamin A, iron and zinc intakes by~     women and young children from two rural provinces of Burkina Faso. The survey also had a~     biochemical component which included blood collection and analysis for indicators of~     deficiency for vitamin A, iron and zinc. Other important components of this study included~     anthropometric measurements, household and child morbidity questionnaires, and collection of~     sorghum samples for analysis of phytate, vitamin A, iron and zinc content.~   "
52029|NCT02376127|"~     The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced~     Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the~     spine. The study aims to see if using these methods will help better see response to~     treatment with radiation in patients with spine metastases from any solid cancer.~   "
52030|NCT02376114|"~     Glaucoma is one of the leading causes of blindness. Ginkgo biloba may be part of an~     effective treatment strategy for glaucoma because it has been shown to improve blood flow,~     it has antioxidant properties, it can relax smooth muscle, and it can protect neurons from~     damage. The goal of our study was to determine whether Ginkgo biloba would result in~     increased ocular blood flow which may protect against glaucoma damage.~   "
52031|NCT02376101|"~     The purpose of this current study is to evaluate whether the size of the endotracheal tube~     (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If~     there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be~     inherent risks associated with the use of a cuffed endotracheal tube that is less than the~     appropriate size. The investigators believe that the size of the tube chosen has an impact~     on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing~     pressure are variable.~   "
52032|NCT02376088|"~     Patients with GD often present with glucose dysregulation, which, according to most studies,~     is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin~     resistance (IR). Current studies focus mainly on IR, and a few that investigate islet β-cell~     functions show inconsistent results. This study examined the characteristics of glucose~     dysregulation in Chinese patients with GD, and furthermore evaluated the effects of thyroid~     dysfunction on islet β-cell functions and subsequently the carbohydrate metabolism.~   "
52033|NCT02376075|"~     A recent study with the DPP-IV inhibitor Linagliptin showed an improvement in the urinary~     albumin creatinine ratio in patients with diabetic nephropathy. Gutzwiller et. Al. have~     shown that GLP-1 increases renal Na secretion and inhibits renal H secretion, further~     indicating some direct renal effects of GLP-1.~      Therefore, it seems likely that treatment with the DPP-IV inhibitor Linagliptin evolves~     several beneficial effects on microvascular and endothelial function beyond glucose control~     which most probably have an impact on the progression of renal and retinal microvascular~     disease.~      The objective of this trial is to investigate the effect of Linagliptin in comparison to~     placebo on the UACR in patients with high blood pressure and an increased albumin excretion.~     Numerous, equivalent endothelial, renal, and retinal parameters serve as objectives of the~     study. All study parameters will be handled in an exploratory sense for the generation of~     models to further discuss the role of DPP-IV inhibition on renal and retinal physiology.~   "
52034|NCT02376062|"~     Mental healthcare is severely neglected in resource-limited countries, including Nepal.~     Nepali clinicians typically spend little time during their clinical education on mental~     diseases. The authors conducted a needs assessment of Primary Care Providers (PCPs) at a~     district level hospital in Nepal using focus group discussions, which revealed clinical~     deficiencies in providing mental healthcare. The authors will develop and implement~     computer-based educational modules to provide training in mental health for Nepali PCPs.~     Effectiveness of PCPs' comfort level, knowledge and skills in evaluating, diagnosing and~     managing mental illness will be assessed by administering pre- and post-tests.~     Acceptability, feasibility and PCPs' comfort-level with the educational modality will also~     be assessed. Data from the tests will be analyzed using paired t-tests. Additionally, data~     from the focus group discussions will be further analyzed to assess for themes that might be~     common among PCPs in other parts of rural Nepal, or regions where access to psychiatrists is~     very limited.~   "
52035|NCT02376049|"~     An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical~     Agents in Adults with Mild to Moderate Atopic Dermatitis.~   "
52036|NCT02376036|"~     The primary goal of this Phase 1 study is to assess the safety and tolerability of one~     MGD010 intravenous (IV) infusion in healthy adult volunteers.~   "
52037|NCT02376023|"~     The purpose of this study is to evaluate the implementation and effectiveness of text~     messages as a means for improving adherence to cervical cancer screening.~   "
52038|NCT02376010|"~     Current oral anti-coagulation for atrial fibrillation is most commonly performed with~     warfarin. Warfarin is a vitamin K antagonist that has been shown in non-randomized trials to~     increase vascular calcification. Increased vascular calcification has been tied to increased~     cardiovascular events (CVE). This study will randomize patients currently taking warfarin to~     either continue on warfarin or be switched to rivaroxaban. Rivaroxaban is an oral~     anti-coagulant that works by inhibiting Factor Xa, and has no interaction with vitamin K.~     This study is a randomized, open label study that will randomize 120 patients and have them~     undergo blood tests and a calcium scan at baseline, and again after 12 months. Patients will~     be seen quarterly for examinations, safety checks and supply of rivaroxaban, as well as~     follow up INR testing for warfarin.~   "
52039|NCT02375997|"~     The majority of patients with newly diagnosed metastatic ESCC and gastric cancer patients~     experience a number of physical and psychosocial symptoms related to their cancer. Those~     patients endure the greatest level of distress from their disease relative to other cancer~     populations in China. Although new drugs have been applied in recent years, the median~     overall survival time of metastatic ESCC and GC patients are still around 12 months.~     Therefore, it is essential to maximize their quality of life (QOL) from the time of~     diagnosis. Multiple studies demonstrate that symptoms such as pain, fatigue, and anorexia~     are prevalent at diagnosis and worsen over time. As a result, suffering increases throughout~     the course of the illness. To be most effective, palliative care with intensive symptom~     management and psychosocial support should begin at the time of diagnosis, not once~     life-prolonging therapies have failed. And some studies have revealed that early palliative~     can even prolong the overall survival time in advanced lung cancer. The investigators then~     initiated a randomized phase III clinical trial with standard oncology care plus early~     palliative care or not in metastatic esophageal carcinoma and gastric cancer to observe~     whether the early palliative can improve the QOL and even prolong the overall survival time~     in those patients~   "
52040|NCT02375984|"~     The purpose of this protocol is to determine whether autologous TIL infused in conjunction~     with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and~     fludarabine can cause consistent and durable objective responses in patients who have~     metastatic melanoma at the John Wayne Cancer Institute (JWCI).~   "
52041|NCT02375971|"~     The purpose of this study is to determine if intravitreal ranibizumab is superior to laser~     ablation therapy in the treatment of retinopathy of prematurity (ROP).~   "
52042|NCT02375958|"~     A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.~   "
52043|NCT02375945|"~     Swelling is a common problem after knee arthroplasty often leading to delayed wound healing,~     lasting functional impairment and hematoma.~      Due to this complications, sometimes the risk for deep venous thrombosis is raised. This~     study investigates a new self adjustable device to reduce swelling more effective~     postoperatively. The investigators compare the new device to the current general practice by~     using a standard class 1 elastic stocking~   "
52044|NCT02375932|"~     Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient~     and provider priorities during primary care visits represents a barrier to effective primary~     care. The investigators propose to design, implement, and evaluate in a randomized clinical~     trial a web-based tool linked to the electronic health record (EHR) that will enable complex~     patients to easily define care priorities for their upcoming visit.~   "
52045|NCT02375919|"~     The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and~     tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED)~     amongst low risk patients. Even though meta analyses have confirmed the safety of its~     utilization, equipoise remains - especially in European country where the prevalence of PE~     is higher than in the US- on whether this rule could be safely applied to all low risk~     emergency patients with a suspicion of PE.~      The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit~     patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of~     PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months,~     and PERC based strategy for 6 months.~      In the control group (usual strategy), patients will be tested for D-dimeres, followed if~     positive by a Computed Tomography of Pulmonary Artery (CTPA).~      In the intervention group (PERC Based), patients will be first assessed with PERC score. If~     PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If~     PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.~      The primary outcome is the failure percentage of the diagnostic strategy, defined as~     diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom~     PE has been initially ruled out.~   "
52058|NCT02375750|"~     The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and~     Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to~     peri-implantitis disease.~   "
52046|NCT02375906|"~     Hepatitis delta is a major health problem, not only because of the severity of the disease,~     but also due to the lack of effective antiviral treatment. To improve the current~     therapeutic options, a better understanding of the pathophysiology is essential. Reliable~     research in this direction is only possible with large patient study groups. However, given~     the geographic distribution of hepatitis delta, larger patient cohorts would only be~     possible through multicenter collaboration.~   "
52047|NCT02375893|"~     The purpose of this study is to describe the composition of bile acids and the gut~     microbiota comparing two populations: patients with coronary atheroma and the healthy~     subjects.~      Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory~     effect of certain bile acids, and the role of the gut microbiota in the metabolic~     regulation.~   "
52048|NCT02375880|"~     DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and~     is being developed as an anti-neoplastic agent. This study is designed to evaluate the~     safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination~     with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or~     exta-hepatic biliary system or gallbladder.~   "
52049|NCT02375867|"~     Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The~     mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is~     considered to be mainly immune mediated with augmentation of cytolytic pathways of infected~     hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the~     disease by suppressing the immune system. As FHF results from liver cell death with~     insufficient hepatocellular regeneration, so we postulates that administration of agents~     that help liver cell regeneration as growth hormone may help to overcome this life~     threatening condition.~   "
52050|NCT02375854|"~     The objective of this protocol is to investigate the impact of prematurity, with or without~     associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by~     establishing a patient registry and biorepository. Serum and urine samples will be collected~     serially from premature infants admitted to the neonatal intensive care unit (NICU) at~     Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU~     follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will~     be linked to a comprehensive clinical database.~   "
52051|NCT02375841|"~     The purpose of this study is to learn more about the way physicians communicate with brain~     tumor patients. This study will look at how oncologists provide information about brain~     tumors, brain scan results, and treatment options. This study will look at how oncologists~     provide information about brain tumors, brain scan results, and treatment options.~     Ultimately, the investigators hope to use these findings to improve communication between~     patients, caregivers and their doctors.~   "
52052|NCT02375828|"~     The understanding of the molecular mechanisms of neonatal diabetes has deeply changed the~     therapy of patients carrying mutations in the K-ATP channel. Indeed, those patients are not~     treated anymore by insulin injections but by glibenclamide an oral anti-diabetic drug widely~     used in type 2 diabetes. Anyway, its galenic form (pills of 5 mg) is not suitable for~     children and difficult to administrate to infants or young children. The purpose of this~     study is to determine if a new galenic form of this durg is more suitable and as efficient~     as pills in children with neonatal diabetes.~   "
52053|NCT02375815|"~     This study is designed to answer a key question in the field of implementation science.~     Specifically, it seeks to determine if a proposed model for the implementation and scale-up~     of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the~     potential of this model, the investigators will conduct a multi-year study comprising 3~     phases. This proposal represents the first of these phases.~   "
52054|NCT02375802|"~     This pilot study of 12 patients (6 control, 6 experimental) will test the safety and~     efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a~     Stage III or IV pressure ulcer. Patients in both groups would undergo a minimal risk~     liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed~     to extract the stromal layer of cells that contain stem cells. The ASCs would be injected~     into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to~     assess wound healing and tolerance of the treatment.~   "
52055|NCT02375789|"~     This study will be a randomised placebo controlled trial examining the effectiveness of~     using an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms~     of acute migraine. It will involve using two nasal catheters to cool the nasal cavity which~     provides localised cooling of the local nasal tissue and the blood vessels which supply~     blood to the brain. This cooling effect will cause the blood vessels to constrict as well as~     stimulating special cold receptors that are thought to be involved in the relief of~     migraine, thereby providing both pain and associated symptomatic relief. Ninety patients~     will be randomised in a 1:1 fashion, clustered to three different recruitment sites. The~     patients will have a 30 day period of data collection for their current migraine frequency,~     treatment and response to medication (with a minimum of 2 migraine attacks recorded) before~     starting the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine~     attacks. Only a single treatment is allowed for the first attack, but on the second attack~     the patient may deliver 2 treatments with a gap of at least 2 hours between treatments.~   "
52056|NCT02375776|"~     This study evaluates a smart phone based mobile application designed for patients with Renal~     Cell and Prostate Cancer taking oral anti-cancer medications. (OAMs) All participants will~     be patients at the Dana Farber Cancer Institute in Boston, Massachusetts. Half of the~     participants will use the mobile application for a 3 month period along with their usual~     care. Half of the participants will just receive usual care.~      The investigators hope to show that cancer patients taking OAMs who use the mobile~     application will be better connected to their care team and will develop increased~     competency for self-care which will primarily increase medication adherence.~   "
52057|NCT02375763|"~     Children will be recruited from the pediatric dentistry clinic of Marquette University at~     their first or recall appointment and will be asked to fill a questionnaire regarding their~     dietary habits. Afterwards a dietary analysis will be performed using a computer software,~     developed for this study and dietary instructions will be given to the children.~   "
63180|NCT02230293|"~     The purpose of this study is to determine if multidisciplinary care improves the health~     condition of hypertensives.~   "
52059|NCT02375737|"~     The investigators propose to evaluate the implementation of an efficacious medication~     adherence program in a group at high risk for CVD. The program involves patients~     receiving/responding to e-reminders to take CVD medications via patient-selected technology~     [mobile/web-based applications, short message service (SMS; text messaging), interactive~     voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program~     administered by either research staff or a case manager staff member from the Duke~     Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.~   "
52060|NCT02375724|"~     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID~     compared with placebo on COPD symptoms in a symptomatic patients population with moderate~     COPD and chronic bronchitis, and particularly assess the effects in cough by using specific~     tools to assess the occurrence and impact of this relevant COPD symptom.~   "
52061|NCT02375711|"~     The aim of this study is to investigate the role of immunosenescence in the HBV vaccination~     response in patients with renal insufficiency.~   "
52062|NCT02375698|"~     This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity~     study in adults who have recently been successfully treated for drug-susceptible pulmonary~     Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in~     HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be~     investigated. The study will be conducted at one or more sites in South Africa.~   "
52063|NCT02375685|"~     The objective of this study is to evaluate long-term safety of gevokizumab in patient with~     chronic non-infectious uveitis who previously well tolerated the study drug and may benefit~     from longterm treatment with gevokizumab.~   "
52064|NCT02375672|"~     This is a multi-institutional, single arm, open-label, phase II study, including a safety~     run-in cohort. No randomization or blinding involved.~   "
52065|NCT02375659|"~     Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing~     medical care and supporting research related to patients with skin of color. There have been~     no formal studies evaluating why patients seek medical care at SOC clinics or treatment~     outcomes. Reasons may include past experiences with other providers, the perception that~     providers working in these clinics have a special interest or knowledge in caring for~     patients with skin of color and thus may provide better care, the expectation of cultural~     sensitivity, the hope that their provider may have a similar ethnic background, and/or ease~     of communication with their provider. Through focus group discussions we aim to identify the~     factors influencing a patient's choice to seek medical care at a SOC clinic and to gain~     insight into the presence and impact of racial concordance between provider and patient. The~     current study will focus on self-identified African American patients with interest in~     conducting similar sessions with patients of other ethnicities and races in the future.~   "
52066|NCT02375646|"~     One of the well-known of complications post colonic polypectomy is bleeding usually occuring~     in the 2-week period following the procedure. Patients treated with oral anticoagulation~     (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand~     to prevent thromboembolic events, and on the second hand to minimize the risk of~     post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment~     while bridging with LMW Heparin while resuming Warfarin treatment following the procedure.~     This practice was found to be associated with a much higher rate of bleeding compared with~     continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The~     fact that most post-polypectomy bleeding occurs within the 2-week period further questions~     the current practice of periprocedural bridging therapy. the investigators therefore~     hypothesize that patients with continuous Warfarin treatment may have similar~     post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW~     Heparin.~      This is a multicenter single-blinded prospective randomized trial comparing small~     post-polypectomy (polyps<10mm) bleeding rates between two groups of patients: Continuous~     therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current~     practice).~   "
52067|NCT02375633|"~     A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical~     Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain~     Patients.~   "
52068|NCT02375620|"~     The study was evaluated as the optimal dose for the treatment of SGA short stature children~     by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of~     SGA short stature children and provided scientific, reliable basis for phase III clinical~     trials for dose selection.~   "
52069|NCT02375607|"~     The purpose of this study is to determine the correlation between preoperative algometer~     score and the amount of postoperative analgesic consumption. The algometer score of the~     patients will be recorded in the preoperative period. In postoperative period, the analgesic~     consumption rate will record and compare with the algometer score.~   "
52070|NCT02375594|"~     Exercise park equipments for the elderly are designed taking into account the physical and~     cognitive capabilities and needs of elderly individuals. These equipments are usually built~     in public spaces, and may be part of public health initiatives to promote active lifestyles~     in the elderly.~      Previous research has provided clear evidence on the short-term efficacy of exercise~     programs in improving physical function and level of physical activity in community-dwelling~     elderly. The goal of this randomized clinical trial is to assess whether an exercise~     intervention conducted in an exercise park equipment is able to achieve sustained~     improvements in physical function and level of physical activity, that are maintained for at~     least 3 months after the end of the intervention. The target population are~     community-dwelling elderly that are insufficiently active.~   "
52071|NCT02375581|"~     To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with~     concurrent radiotherapy in older patients with esophageal cancer.~   "
52085|NCT02375399|"~     Echocardiography parameters for cardiac dyssynchrony had no predictive value in current~     multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive~     echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been~     analyzed, but their definite value has not been proven yet.~   "
52601|NCT02368652|"~     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination~     therapy on patients of essential hypertension who are not properly controlled by candesartan~     cilexetil monotherapy.~   "
52072|NCT02375568|"~     According to many recent research, mesenchymal stem cells (MSC) isolated from synovial~     membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency~     and ability to undergo chondrogenesis.~      Based on this concept, the investigators plan to get two removed tissues (synovial membrane~     and infrapatellar fat pad) from patients who have an operation of total knee replacement.~     The investigators are going to isolate and expand MSC from these two tissues respectively,~     and then compare the chondrogenesis ability for clinical application. In the other hand, the~     investigators plan to build techniques and procedures which comply with Good Tissue~     Practices (GTP)~   "
52073|NCT02375555|"~     This research study is evaluating a combination of four drugs -- lenalidomide, bortezomib,~     dexamethasone and elotuzumab -- as therapy for newly diagnosed multiple myeloma.~   "
52074|NCT02375542|"~     This study will analyse factors contributing to cardiac re-operation to determine causative~     effects~   "
52075|NCT02375529|"~     Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used~     as a minimally invasive surgery with potential benefits over 4-port laparoscopic~     cholecystectomy (LC) in terms of postoperative pain and faster recovery.~      Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC~     (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative~     pain and analgesic requirements, success of the ambulatory process, return to normal~     activity and return to work, cosmetic results and quality of life score.~   "
52076|NCT02375516|"~     The planned research aims to delay the onset of drug use and reduce harmful use and abuse~     among Hispanic youths. The culturally-tailored prevention program will be delivered to~     youths by computer. Over 5 years, the program will be developed and tested in a randomized~     clinical trial. The intervention program will include 10 initial sessions, followed by~     annual booster sessions. Outcome measurements will involve baseline, post-intervention, and~     three annual follow-up data collections.~      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower~     among participants assigned to receive the intervention. If proven to be efficacious, the~     program will be revised and disseminated nationally.~   "
52077|NCT02375503|"~     The primary objective of this randomized, double-blind, placebo controlled trial is to~     determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified~     food product on bone turnover markers, including parathyroid hormone (PTH) and~     microarchitecture during Army basic military training (BCT). The investigators hypothesize~     that consumption of a once daily calcium and vitamin D fortified food product will stabilize~     PTH and contribute to improved bone microarchitecture compared to placebo. The results will~     determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover~     markers as well as provide novel data regarding microarchitectural changes during BCT as~     assessed by high resolution peripheral computed tomography (HRpQCT) scanning.~   "
52078|NCT02375490|"~     Childhood obesity is one of the greatest challenges facing public health and recent evidence~     shows it begins in preschool aged children. It has been suggested that interventions be~     carried out to improve physical activity and healthy eating behaviour among young children.~     This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy~     eating intervention for preschool aged children. It is hypothesized that the Healthy Start~     intervention will improve both eating and physical activity behaviors of children attending~     early childcare centers because of its influence on multiple factors.~   "
52079|NCT02375477|"~     This clinical trial studies how well inter-disciplinary educational methods work in~     improving adherence to isolation protocols in patients with Clostridium (C.) difficile~     infections. An inter-disciplinary educational method may help to prevent the spread of~     infection.~   "
52080|NCT02375464|"~     Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron~     emission tomography (PET scan). The material has already been shown to be better than the~     currently available imaging agents. This study is designed to evaluate the clinical impact~     of PET CT scanning using this agent in the evaluation and management of patients with NETs.~   "
52081|NCT02375451|"~     Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in~     adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The~     investigators goals are to answer this question by measuring salivary gland function before~     and after I-131 administration in children who receive radioiodine therapy at our hospital~     for thyroid disease.~   "
52082|NCT02375438|"~     The aim of this study is to assess nutritional intake (quantitatively and qualitatively),~     nutritional state and body composition of patients suffering from mitochondrial cytopathy,~     compared to healthy controls. The energy intake will be calculated through dietary~     protocols, the energy expenditure by indirect calorimetry and body composition will be~     performed with bio-impedance analysis. Further on, the investigators expect to be able to~     provide nutritional counselling to this population in order to increase energy and protein~     intake, which may improve health and well-being.~   "
52083|NCT02375425|"~     The development of surrogates to predict HIV prevention product safety and efficacy is a~     high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue~     exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab~     showed significant reduction in HIV replication when compared to tissue exposed to placebo~     gel. Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under~     development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA.~     Currently the Reproductive Infectious Disease Research Group is conducting a study designed~     to answer important questions about the ex vivo challenge model:which HIV virus is the best~     to use in the laboratory and what is the best indicator of HIV infection. The proposed study~     delineated here will investigate the effect of BV, HSV and contraceptive use on the model .~     There will be two arms to the study; the first will investigate the impact of HSV and BV~     status and the second, contraceptive use. Vaginal and cervical biopsies will be collected~     from participants for the ex vivo challenge model.~   "
52084|NCT02375412|"~     The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic~     nervous system could complicate the postoperative course in the patient undergoing surgery.~     Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the~     autonomic nervous system.~   "
63747|NCT02222883|"~     The aim of this prospective registration and translational research study is to evaluate the~     praevalence of BRCA regarding germline and somatic mutations.~   "
52086|NCT02375386|"~     This is study testing the feasibility of collecting neurophysiological measures of outcome~     related to body-based interventions for low back pain. The investigators will collect fMRI~     and psychophysical data about pain sensitivity before and after the interventions.~     Participants will be randomly assigned to either spinal manipulation or therapeutic touch~     groups. Participants will attend two practice sessions prior to the first data collection.~     There will be two follow-up assessments.~   "
52087|NCT02375373|"~     This prospective study will assess the effects of adding legumes, especially chick peas, to~     the diet of healthy adults on the commensal bacteria from feces of human subjects and~     resulting self-reported GI symptoms as well as markers of immune function.~   "
52088|NCT02375360|"~     Patients with food allergy and their parents will answer a food allergy quality of life~     questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled~     also by patients undergoing oral immunotherapy (OIT).~   "
52089|NCT02375347|"~     This prospective study will assess the effects of adding legumes, especially chick peas, to~     the diet of healthy adults on the commensal bacteria from feces of human subjects and~     resulting self-reported GI symptoms as well as markers of immune function.~   "
52090|NCT02375334|"~     This research trial studies an adherence monitoring system in managing myelosuppression in~     patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation~     therapy. The development of an adherence monitoring system may help doctors more effectively~     utilize electronic medical records to manage myelosuppression during standard treatment with~     temozolomide and radiation therapy in patients with malignant gliomas.~   "
52091|NCT02375321|"~     Many researches have shown that patients with Obstructive Sleep Apnea (OSA) and often also~     the family members have a decreased quality of life, problems related to the sexual sphere,~     depressive disorders and anxiety problems. To date still remains controversial the~     relationship between OSA and quality of life, also the link between sleep apnea syndrome and~     depression is unclear.~      In adult patients with OSA the treatment of choice is the application of a continuous~     positive airway pressure (CPAP: Continuous Positive Airway Pressure) at the opening of the~     airways. With the CPAP treatment the sleep normalizes and daytime sleepiness fades or~     disappears.~      Many studies have shown that this treatment determines improvement of the medical and~     psychological status. However, the rate of non-adherence to treatment reported in the~     literature is about 46-83%, considering as adherence the use of CPAP for at least 4 hours~     per night. A recent study has shown that CPAP used as a single treatment in patients with~     OSA and depression, has reduced the depressive symptoms but in a significant percentage of~     patients (42%), the depressive symptoms remained unchanged or worsened. At the present time~     have not been published, to our knowledge, studies concerning the effectiveness of the~     combined treatment of CPAP and psychological support on the mood and on the quality of life~     OSA patients.~      Therefore the aim of this study is to evaluate the effects of the combined treatment with~     CPAP and psychological intervention with cognitive behavioural therapy on the mood and on~     the quality of life of OSA patients.~   "
52092|NCT02375308|"~     The purpose of the study is to compare the efficacy of an Hypnotherapeutic Treatment of~     Depression to Cognitive Behavioral Treatment of Depression in patients with mild to moderate~     Major Depressive Episodes.~   "
52093|NCT02375295|"~     The aim of this research is to determine an effective antibiotic regimen following~     definitive surgical therapy of kidney stones caused by bacterial infection (struvite~     stones).~   "
52094|NCT02375282|"~     Ambulation following surgery has been found to be beneficial for patients; however, nurses~     and doctors struggle with getting post-operative, hospitalized patients to walk on their~     own. One promising strategy to address this might be an ambulation orderly, an employee~     whose single responsibility is to assure that patients walk 3-4 times per day. However, the~     effect of the ambulation orderly on post-operative physical activity has not yet been~     described. It is important to quantify what the ambulation orderly does in order to assess~     if this is an effective method for helping patients walk. As a result, the investigators~     will perform a pilot randomized controlled trial to test the effects of an ambulation~     orderly in patients hospitalized with recent cardiac surgery. Half of the patients will be~     assigned to walk with the ambulation orderly 3-4 times/day and the control group will be~     given standard nursing encouragement and assistance and encouragement to walk. The~     investigators will evaluate the average total daily step counts (over the hospital course,~     usually 4-7 days) and the change in walking distance between a baseline and a final 6 minute~     walk test. The investigators will also evaluate exercise physiologic parameters (heart rate,~     oxygen saturation) during ambulation, patient functional independence, and patient~     satisfaction.~   "
52095|NCT02375269|"~     Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10~     minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose~     in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes~     and deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate~     platelets and factors platelet dependent factors such as Serotonin and VEGF. These humoral~     factors have a systemic effect and have the potential to protect target organs (i.e. heart,~     kidney, liver) remote to the ischemic limb.~      The purpose of this randomized controlled study is to investigate the influence and impact~     of RIPC on postoperative complications in patients undergoing visceral surgery~   "
52096|NCT02375256|"~     Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to~     receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on~     Study Days 0 and 28. Subjects were followed for a total of 98 days.~   "
52097|NCT02375243|"~     The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for~     sedatives and analgesics in the immediate post-operative period in children who underwent~     surgical correction of complex congenital heart disease~   "
52109|NCT02375087|"~     Up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from~     arrhythmias. Sleep apnea is prevalent in myotonic dystrophy (DM1) patients. Among the~     serious complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac~     death (SCD). Diagnosis of sleep apnea using simple tools in ambulatory cardiology practice~     may improve therapy of cardiac arrhythmias in patients with DM1~   "
55726|NCT02327728|"~     To evaluate the efficacy of different botulinum toxin A injection patterns in treating~     benign essential blepharospasm and to compare their influence on condition of eye surface .~   "
52098|NCT02375230|"~     Establishing breathing after birth is vital for survival and long-term health of premature~     babies. 10% of all preterm babies fail to breathe after birth and require help with~     breathing. When infants need help with breathing the clinical team will place a small mask~     on the babies face to give some breaths to help the baby breath (what the investigators call~     mask ventilation).~      This procedure is done million times a day around the world and several times a day here at~     the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most~     difficult step in helping a baby breath at birth. If this is provided wrongly then baby does~     not receive enough oxygen, which could damage the brain and even cause death.~      To keep the skill level of every staff member up-to-date every staff member is required to~     re-train this rescue breaths via mask ventilation once every two years.~      The investigators believe this is not enough and that daily trainings are necessary to keep~     your skills up-to-date.~      The investigators aim to compare to different teaching techniques using daily trainings to~     see if either improves the skills of the resuscitator providing mask ventilation~      The study will last 7 month (baseline observations (2 months), intervention period (3~     months), After trial period (2 months)~      The investigators will use our routinely used equipment to record neonatal resuscitation and~     the investigators also routinely make video recordings to evaluate performance during~     resuscitation.~   "
52099|NCT02375217|"~     Prospective Randomized non inferiority Trial involving adult patients undergoing elective~     surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose~     sugammadex vs half dose sugammadex for reversal of NMB.~   "
52100|NCT02375204|"~     This randomized phase III trial studies how well standard-dose combination chemotherapy~     works compared to high-dose combination chemotherapy and stem cell transplant in treating~     patients with germ cell tumors that have returned after a period of improvement or did not~     respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin,~     carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. Giving colony-stimulating factors, such as~     filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the~     bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to~     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to~     the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It~     is not yet known whether high-dose combination chemotherapy and stem cell transplant are~     more effective than standard-dose combination chemotherapy in treating patients with~     refractory or relapsed germ cell tumors.~   "
52101|NCT02375191|"~     The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to~     ropivacaine in pediatric orthopedic surgery~   "
52102|NCT02375178|"~     This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of~     chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the~     oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to~     control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile~     saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed~     to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to~     polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth~     with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of~     saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples~     will be plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples~     will be processed by a blinded microbiologist.~   "
52103|NCT02375165|"~     Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is~     frequently under-recognized or misdiagnosed. This study is designed to lead to the~     development of an accurate, noninvasive, blood test to allow testing for lymphedema.~   "
52104|NCT02375152|"~     Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a~     worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of~     pharmacological and behavioural treatment methods for most OCD patients, roughly one third~     do not demonstrate significant symptom improvement, even after aggressive treatment (Foa et~     al, 2007). The effectiveness of neurosurgical treatment methods (including ablative surgery)~     for those with severely disabling treatment resistant OCD is substantiated by clinical~     research (Greenberg, Rauch & Haber, 2010). The brain target of this procedure is usually the~     area between the anterior and middle third of the anterior limb of the internal capsule.~   "
52105|NCT02375139|"~     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of~     DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).~   "
52106|NCT02375126|"~     In this study, the investigators will collect EEG data in normal, healthy volunteers without~     a history of prior brain injury. This data will be analyzed by computer (quantitative, or~     qEEG) and stored in a normative database so that, in the future, the investigators can~     better understand and characterize the brain damage that can result from carbon monoxide~     (CO) poisoning and other types of brain injury.~   "
52107|NCT02375113|"~     This is a pilot study examining the effect of dietary supplements that contain soy products.~     The purpose of this study to find out if soy supplementation can help to reduce the storage~     of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the~     abdomen; it has the potential to increase the risk of certain health problems.~   "
52108|NCT02375100|"~     This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve~     block for postoperative pain in patients undergoing inguinal herniorraphy with spinal~     anesthesia. One-third of the patients will receive standard postoperative pain~     regimen(control group), one-third will receive a transversus abdominis plane block (with~     ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with~     ultrasound guidance) in addition to standard postoperative pain regimen. This study is a~     Randomized prospective open-label controlled study.~   "
52283|NCT02372825|"~     Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a~     formidable challenge for the reconstructive surgeon. These defects can be treated with the~     vascularized iliac crest transfer. The purpose of this study is to assess the reliability~     and the long-term outcomes of free iliac crest flap transfer for these indications.~   "
52110|NCT02375074|"~     Long-lasting sickness absence is a risk factor for permanent disability, and the share of~     young workers falling into early disability is an increasingly important problem in Norway.~     Early withdrawal or exclusion from the labor market leads to large individual and societal~     costs. The SEED-trial is a randomized controlled trial aiming to provide evidence-based~     knowledge about different approaches to prevent permanent disability and increase labor~     market participation in this important and vulnerable group. The trial includes unemployed~     individuals aged 18-29 years, and the participants will be randomly assigned to 1 of 2~     interventions, both aimed at facilitating participation in working life:~        1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the~          labor market in a sheltered environment~        2. Supported Employment (SE), focusing on competitive employment in real-life settings~          without long-lasting preceding training~      Both interventions are currently provided by The Norwegian Labor and Welfare Administration~     (NAV). Supported Employment was introduced recently and is currently being implemented,~     while traditional vocational rehabilitation with sheltered employment has been around for~     years. However, no Norwegian controlled studies have been conducted on these practices in~     this population. The current study will therefore provide new knowledge of the effect of~     traditional as well as new and promising interventions to increase labor market~     participation and prevent early disability.~   "
52111|NCT02375061|"~     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best~     Possible Self, BPS) over optimism, future expectancies and positive affect at mid-term, in~     comparison to a control group, in fibromyalgia patients. The principal hypothesis is that~     the BPS intervention will enhance significantly the levels of optimism, positive future~     expectancies and positive affect in comparison to the Control group at short and mid-term.~   "
52112|NCT02375048|"~     Selected patients with early stage breast cancer undergone conservative surgery were~     randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial~     Breast Irradiation.~   "
52113|NCT02375035|"~     To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of~     undertaking prostate biopsy as part of their clinical management.~   "
52114|NCT02375022|"~     This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin~     (Endostar®) works in treating patients with advanced stage non-small cell lung cancer~     (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the~     ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib~     is more effective when given with rh-endostatin in NSCLC patients with EGFR activating~     mutations.~   "
52115|NCT02375009|"~     This proposal aims to evaluate selective laser trabeculoplasty (SLT) as a safe and effective~     therapy to control open-angle glaucoma and reduce the risk of progression to visual~     dysfunction or blindness in the African-derived developing world. If funded, this work will~     complete the characterization of SLT's safety and efficacy profile as a means of long-term~     disease control in this population. This work will support the translation of SLT into a~     structured public health initiative to reduce glaucoma-related vision loss throughout the~     African-derived developing world.~   "
52116|NCT02374996|"~     Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a~     state when the body is not using insulin correctly, and more insulin is needed to maintain~     normal blood sugar. Insulin resistance is common in bipolar patients and even more common in~     bipolar patients treated with antipsychotics. Insulin resistance from antipsychotics can~     lead to type 2 diabetes, metabolic syndrome and cardiovascular disease and is known to lead~     to worse psychiatric outcomes (less mood stability) and lower life expectancies in bipolar~     disorder. Abnormal regulation of the folate cycle is known to play a role in~     antipsychotic-induced insulin resistance and the main endpoint to the folate cycle is the~     production of methyl donors for DNA methylation. DNA methylation is critical as it regulates~     how genes are expressed. Thus, changes in DNA methylation may play a role in the disease~     process of antipsychotic-induced insulin resistance. The purpose of this study is to examine~     the differences in the DNA methylation of candidate tissues known to have a role in the~     development of insulin resistance. The three groups of bipolar patients to be studied are 1)~     antipsychotic treated patients with impaired glucose tolerance, 2) antipsychotic treated~     patients with normal glucose tolerance and 3) lithium treated patients with normal glucose~     tolerance. Group 1 will be compared to groups 2 and 3 in order to assess how DNA methylation~     in the skeletal muscle and fat tissue changes due to medication effects (group 2 vs. 3) and~     medication side effects (group 1 vs. 2). Secondary analyses include the analysis of how fats~     are processed in skeletal muscle and fat tissue in relation to antipsychotic-induced insulin~     resistance and the correlation of DNA methylation across different tissues. The~     investigators hypothesize that antipsychotic-induced insulin resistance is to due changes in~     the way DNA is expressed (through epigenetic changes) which causes further changes in the~     way fats are processed in the body eventually leading to insulin resistance. This work is~     based on preliminary findings however further work is needed to identify the true mechanisms~     behind antipsychotic-induced insulin resistance and in particular, the main tissue in which~     this mechanism occurs.~   "
52117|NCT02374983|"~     Gamma Knife Radiosurgery (GKR) is a well established treatment modality for brain tumors and~     functional disorders of the brain. It relies on mathematical algorithms to predict dose~     distribution and to calculate the dose at arbitrary points in the head. For the last 25~     years, doses applied using Gamma Knife Radiosurgery have been calculated using a simple~     algorithm, called the Tissue Maximum Ratio algorithm (TMR). Dose planning using this~     algorithm, relies on a number of approximations to enable fast isodose computation during~     treatment planning. One of the most significant of these is the approximation of the head to~     water-equivalent density. The increased electron density of brain and bone (relative to~     water) and the near-zero density of air cavities in the skull may make significant~     perturbations to isodose and beam-on time calculations.~      With the advent of faster workstations, the effect of tissue in-homogeneities can finally be~     calculated in reasonable time during the treatment planning process; a newer, more modern~     algorithm known as convolution algorithm is now commercially available. It uses the values~     of density indicated in the CT scan to predict the dose distribution and is expected to more~     accurately calculate radiation dose, although it needs further investigation before clinical~     implementation. Inter- and intra-indication differences between the old and new algorithms~     need to be understood before this method can be confidently employed in a clinical setting.~     It is the aim of this study to understand the dosimetric differences between these dose~     calculation algorithms and to evaluate the implications of using the convolution algorithm~     for GKR. A large number of treatments will be re-planned using the convolution algorithm and~     compared to the TMR plans used to treat the patients. Beam-on-time, which is proportional to~     dose and a number of commonly used metrics for the targets such as coverage, selectivity,~     gradient index, and mean and maximum dose, will be estimated with both algorithms. Subgroup~     analysis will be done to assess whether any factor such as diagnosis, size of the head or~     location of the target could impact on the relative difference between the methods. The~     treatment plans will be compared and the potential implications on treatment planning will~     be elucidated.~   "
52128|NCT02374840|"~     The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help~     healthcare providers manage patient medication regimens and assess if the testing has an~     effect on reducing medication side effects, hospitalizations and emergency department~     visits.~      The way an individual processes a drug is in part determined by their genes, and there is~     known to be genetic variation between humans in the way drugs are metabolized. The study of~     the way genes affect a person's response to drugs is known as Pharmacogenomics.~   "
52129|NCT02374827|"~     To compare the feasibility and surgical outcomes between complete salpingectomy and standard~     postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women~     with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.~   "
52118|NCT02374970|"~     Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the~     lumbar vertebral or paravertebral region without any reference to the structure or cause of~     the process. It is one of the most widespread diseases and one of the most common reasons~     for visits in primary care setting.~      Exercises to improve lumbar stability involving co-contraction of the transversus abdominis~     have proved to be effective in reducing pain and improving function. It has been stated by~     ultrasound images that specific stabilization exercises cause contraction of the deep~     abdominal muscles, but it remains unclear whether training produce thickness muscle~     improvement and if this improvement is related to clinical findings.~      To try to resolve this issue a project of an experimental trial, double-blind (patient and~     evaluator) with two groups randomly assigned is presented. All participants will be~     recruited in an primary care center of the Catalan Health Institut and will sign informed~     consent. All will receive a protocolized treatment with therapeutic exercises and~     thermotherapy and, additionally, those assigned to the intervention group were instructed in~     performing lumbar stability exercises.~      Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus~     abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end~     of treatment protocol (12 sessions) and three months after the end of treatment will be~     assessed.~      Results in pain, function, and its correlation with the mean changes in the thickness of~     transversus abdominis will be analyzed.~   "
52119|NCT02374957|"~     Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm~     (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the~     treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to~     collect quality of life data on patients undergoing peripheral revascularization in order to~     determine the sample size required to adequately power a trial of Cilostazol versus usual~     care without Cilostazol and its effect on quality of life.~   "
52120|NCT02374944|"~     This study is a multicenter prospective randomized control trial comparing hardware~     retention (HR) to removal of hardware (RH).~   "
52121|NCT02374931|"~     This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES)~     positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid~     tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives~     off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that~     may show where tumor cells with estrogen receptors can be found in the body.~   "
52122|NCT02374918|"~     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury~     in the investigators society. Patients with post-concussion syndrome have been shown to have~     deficits on tests of short term memory, divided attention, multi-tasking, information~     processing speed, and reaction time, as well as alteration in mood and emotional~     functioning. Many patients have other vague complaints including fatigue, dizziness,~     irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of~     one of the most common complaints in patients suffering from traumatic brain injuries, with~     as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these~     patients are associated with poorer outcome, while resolution of the sleep disturbance is~     associated with improvement in cognitive functioning.~      Despite recent evidence of the correlation between sleep quality and recovery from traumatic~     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,~     there have been virtually no direct studies of the causal effects of sleep on recovery~     following mTBI. However, it is quite likely that sleep plays a critical role in recovery~     following brain injury.~      A particularly promising non-pharmacologic approach that shows potential in~     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright~     light therapy. For the proposed investigation, the investigators hypothesize that bright~     light therapy may be helpful in improving the sleep of patients with a recent history of~     mTBI and may also have other mood elevating effects, both of which should promote positive~     treatment outcome in these individuals. Bright light therapy may increase the likelihood~     that they will recover more quickly, benefit more extensively from other forms of therapy,~     and build emotional and cognitive resilience.~      This study will also have a healthy control (HC)/effect localization arm that will assist in~     identifying and mapping the brain systems before and after light exposure so that~     researchers may develop further insights into the relationship between concussion, light~     exposure, sleep, and brain function. This healthy control arm will also provide brain~     targets for study in the analysis of the Main Study Arm.~   "
52123|NCT02374905|"~     The investigators wish to investigate the feasibility of using a web based drinking app~     (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient~     clinic in a dental setting.~   "
52124|NCT02374892|"~     The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation~     Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led~     transition intervention in combination with usual care, versus usual care alone, on~     preparing adolescents with congenital heart disease (CHD) to successfully transition from~     pediatric to adult cardiology care. The Canadian Pediatric Society and American Academy of~     Pediatrics have recommended that transition interventions begin in early adolescence.~     Therefore, the investigators propose to conduct a nurse-led intervention that addresses the~     educational needs of 13-14 year olds.~   "
52125|NCT02374879|"~     This is an open-label, non-randomised pilot study, to evaluate user performance and system~     accuracy in blood Glucose monitoring system with glucose adjustment. Twelve male and female~     volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will~     be enrolled in this study.~   "
52126|NCT02374866|"~     The literature data show that long-term monitoring has an effect on weight loss, comorbidity~     and on improving the quality of life. However, there are still no studies on monitoring~     obese patients after taking initial multidisciplinary approach. The recommendations of the~     HAS 2011 advocated continuous monitoring needed to prevent weight regain, monitor the~     consequences of overweight and treat comorbidities. This requires a long-term support. The~     frequency of follow-up consultations is not specified and must be adapted to achieve a~     weight loss target and maintain. Having no specific recommendations on the frequency of~     monitoring, the investigators chose to experiment closer monitoring than our current~     monitoring to assess what is the best frequency monitoring, in terms of: weight loss,~     quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities~     associated with obesity. The recommendations of the HAS 2011 advocate support of a~     multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce~     comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with~     osteoarthritis).~   "
52127|NCT02374853|"~     The purpose of this research is to determine if using the antibiotic vancomycin as a~     preventative topical (on the surface of the skin) treatment during open-heart surgery will~     reduce the risk of developing a sternal wound infection.~   "
52130|NCT02374814|"~     The purpose of this study is to compare the effectiveness of a two dose versus a three dose~     schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.~   "
52131|NCT02374801|"~     The objective of the Continued Access study is to gather confirmatory evidence on the safety~     of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and~     interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac~     Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient~     population that is reflective of current heart failure treatment practice.~   "
52132|NCT02374788|"~     The aim of the study is to investigate the effects of two levels of primary care physical~     activity interventions on metabolic control and cardiovascular risk factors, compared to~     usual care in patients with pre- and type 2 diabetes.~      The hypothesis is that both levels of interventions have effect on HbA1c with the more~     intense Group intervention having superior effects.~   "
52133|NCT02374775|"~     The EMERALD trial is a multinational, multicenter study. The patients presented with~     AMI/definite evidence of plaque rupture and had underwent coronary CT angiography from 1~     month to 2 year prior to the event will be retrospectively searched. Plaques in the~     non-culprit vessels will be regarded as internal control to the ruptured plaque in the~     culprit vessel.~   "
52134|NCT02374762|"~     The goal of this study is to find the best techniques to take non-invasive images of the~     arteriovenous fistula (AVF) in hemodialysis patients.~   "
52135|NCT02374749|"~     Giving both the gap existing between the current recommendations to prevent/detect~     comorbidities and the clinical practice in patients suffering from spondyloarthritis and~     also the specificity of some recommendations to rheumatic diseases, it seems logical to~     check these recommendations in a rheumatologic environment.~      This study with its two parts should be able to demonstrate:~        -  The importance of a systematic evaluation of comorbidities in Spondyloarthritis,~        -  The utility of a nurse-led program of self-assessment and self-management of the~          disease~   "
52136|NCT02374736|"~     The principal objective of this pilot study is to determine whether the progression of~     chronic antibody-mediated rejection (ABMR) could be minimized by the post-transplant~     administration of high dose of Intravenous Immunoglobulins (IVIg).~      We test the hypothesis that repetitive IVIg administration reduces or stabilize the~     progressive loss of transplant function and the evolution to chronic ABMR in stable kidney~     transplant patients with HLA-DSA developed post-transplantion (de novo HLA-DSA) and~     concomitant humoral graft injury.~   "
52137|NCT02374723|"~     Constructs made from cross-linked Human Recombinant Collagen type III are being used instead~     of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients~     serve as controls and are receiving human donor corneas using the same surgical technique.~     The twelve patients will be recruited from the local waiting list for patients to be~     undergoing corneal grafting. If the patients meet the inclusion criteria and agree to~     participate following oral and written consent, they will be randomized to either group. The~     patients will be followed for 12 months and documented with OCT, In Vivo Confocal~     Microscopy, slit lamp photography a o. The study is planned as a safety study with initial~     efficacy documentation.~   "
52138|NCT02374710|"~     Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral~     tunnel placement, very little attention has been given to the tibial tunnel. Researchers~     have suggested that the tibial tunnel be placed in the center of the ACL footprint, which~     they described as being approximately 43% of the way (anterior-to-posterior) across the~     proximal tibia at its widest extent. However, others have suggested that a more anterior~     placement may yield improved biomechanical and clinical results. The center of the ACL~     footprint and the posterior aspect of the anterior horn of the lateral meniscus does not~     yield tibial tunnel placement a consistent percentage of the way across the tibial plateau;~     therefore, guidelines should be based on intraoperative fluoroscopic measurements. However,~     the question remaining is what percentage of the anterior-to-posterior distance across the~     tibia is the ideal location for the tibial tunnel in ACL reconstruction. This study will~     help answer that question.~      Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction~     will be considered for enrollment. Eligible patients will be allocated to one of two groups~     based on the location of the tibial tunnel (anterior vs. posterior) during the surgical~     procedure. In addition to a baseline (pre-operative) evaluation, participants will return~     for follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24~     months.~      The primary objective of this study is to collect subjective and objective measures of~     knee-related function in patients with an anterior vs. posterior placed tibial tunnel~     through 24 months postoperative care.~   "
52139|NCT02374697|"~     The purpose of this study is to determine whether digitalizing pathological slides and let~     it accessible on a server for a second medical opinion (tele-expertise) would reduce the~     time to diagnosis.~   "
52140|NCT02374684|"~     The purpose of this study is to determine the safety and tolerability, and to evaluate the~     pharmacokinetic characteristics and food effect of Methosulide after oral administration in~     healthy adult subjects.~   "
52141|NCT02374671|"~     The purpose of this study is to evaluate the safety and effectiveness of the VisAbility~     Implant System for the improvement of near visual acuity in presbyopic patients.~   "
52142|NCT02374658|"~     The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative~     process might impact inpatients in rehabilitation centres. Participants in this random~     control trial study will be recruited from a slow-stream rehabilitation patient population.~     The study intervention will consist of The Royal Conservatory's Living Through the Arts~     program. Data will be collected using structured and semi-structured questionnaires along~     with observational logs and focus groups. This study will explore the effects of the~     program, comparing the intervention and control group participants' sense of hope and~     optimism for returning to their daily lives, as well as their sense of engagement in their~     physical recovery.~   "
52143|NCT02374645|"~     This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib~     in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and~     progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment.~   "
52160|NCT02374424|"~     Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association~     with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with~     relapsed/refractory DLBCL.~   "
57522|NCT02304198|"~     This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial~     Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).~   "
52144|NCT02374632|"~     After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined~     as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem~     important for appetite reduction and subsequent weight loss after gastric bypass, however it~     is not clear whether different gut hormone responses are responsible for different~     postoperative weight loss responses. The purpose of the study is to investigate gut hormone~     secretion, vagal integrity and the effect of octreotide on ad libitum food intake in~     patients with suboptimal weight loss after gastric bypass and compare results to a matched~     group of gastric bypass operated patients with high postoperative weight loss but similar~     age, sex and preoperative BMI.~   "
52145|NCT02374619|"~     Iron supplementation is very common in athletes, probably due to its catalytic role on the~     oxygen transport and optimal function of oxidative enzymes and proteins during exercise.~      Iron is also characterized as a potent pro-oxidant, as it can lead to increased production~     of reactive oxygen and nitrogen species (RONS) that are involved in critical biological~     processes, such as gene expression, signal transduction and enzyme activity. In exercise,~     low levels of RONS are essential for optimal force production, whereas excessive production~     of RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the~     other hand, RONS are involved in signaling pathways and up-regulation of the expression of~     several genes, and therefore, RONS can provoke favorable effects such as training~     adaptations.~      The purpose of the present study is to investigate the effect of iron supplementation on~     redox status, muscle damage and muscle performance after an acute bout of a valid muscle~     damaging eccentric exercise model in adults and children.~   "
52146|NCT02374606|"~     A strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was~     developed to precisely and conveniently measure static limb strength in patients with ALS.~     The investigator will compare ATLIS data with data from the commonly used ALS outcomes~     measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory~     measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both~     outcomes measures will be performed on 100 subjects collected preferably at bi-monthly~     clinic visits during the study period.~   "
52147|NCT02374593|"~     This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as~     visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric~     levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the~     study for targeted dosing will be compared to controls obtained by retrospective chart~     review. The main outcome is to determine if there is a difference in the frequency of~     over-treatment and under-treatment during the first 6 months of therapy.~   "
52148|NCT02374580|"~     For more than a decade, Uganda's Ministry of Health has led a community health worker~     program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are~     assigned the task of delivering preventative health services and education to their local~     communities. Studies have demonstrated the effectiveness of Uganda's VHTs in improving~     certain health outcomes; however it is known that VHTs are not optimally supported, and~     there has been VHT attrition in recent years. The Ministry of Health has recognized the~     inadequate support of VHTs thus far and is aiming to expand VHTs to all local governments~     and explore ways of sustaining VHTs. The objective of this study is to evaluate the extent~     to which material support is a deciding factor in the efficiency and durability of Uganda's~     VHT initiative. Material support may take the form of monetary stipends, regular payment,~     transportation assistance, or nonfinancial materials such as bicycles or mobile phone~     airtime. This study will review existing literature and gather novel data through surveys of~     VHT members and VHT stakeholders. The quantitative and qualitative survey data will be~     analyzed for trends that may point to a conclusion in the context of existing health policy~     discourse on community health worker remuneration. The purpose of this study is to~     strengthen the knowledge base on whether or not the current absence of material support~     significantly limits the potential for Uganda's VHTs to be sustained and expanded. This~     information can be used by governmental and non-governmental organizations in their work to~     strengthen and sustain VHTs throughout the country.~   "
52149|NCT02374567|"~     The purpose of this multicenter-study is to investigate safety of psychopharmacological~     treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly~     people are at higher risk for developing side effects under pharmacological treatment due to~     an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore~     gerontopsychiatric patients can often not articulate their symptoms clearly, for example due~     to pronounced cognitive impairment.~      The aim of the study is to gain valid data of possible adverse drug reaction rates, their~     potential risk factors and outcome, as well as medical prescription practises.~      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the~     five participating study sites.~      At Baseline demographic data, previous and present disorders, use of drugs, previous and~     present medication, quality of life, cognitive function, physical examination results,~     laboratory results and ECG will be assessed.~      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All~     adverse drug reactions will be coded in the MedDRA-system.~      In case of a possible serious adverse drug reaction serum levels of all psychotropic~     substances applicated will be assessed. Drug combinations will be analysed using an~     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible~     adverse drug reactions are documented continually.~      2 weeks after discharge from the ward, patients will be contacted by phone to assess~     catamnestic data.~   "
52161|NCT02374411|"~     The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy)~     surgeons is to determine their knowledge of and attitudes towards the nutritional support~     needs of HIPEC patients and what their practice patterns are with this patient population.~   "
52162|NCT02374398|"~     The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the~     postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the~     simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit.~     The assumption is that the combination of iv TXA and Aquamantys system will enable an~     improvement in the postoperative hemoglobin and hematocrit equal or larger than the~     improvement generated by the use of Aquamantys system alone.~   "
53566|NCT02355977|"~     To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO)~     and surface and root planning (SRP) by assessing both clinical parameters and the loads of~     four main periodontal pathogens in treating chronic periodontitis.~   "
52150|NCT02374554|"~     Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient.~     Various devices using different techniques are available to measure RR. One technique,~     capnography, uses continuous monitoring of expired gases, via a nasal cannula to assess end~     tidal CO2 concentration. This long-established technique is frequently used for patients in~     intensive care. Both RR and the shape of the capnogram waveform, which has a wave pattern~     marked by alternating inspiratory and expiratory phases, are used to help monitor the~     patient. Clinician Over-scored End Tidal C02 (COSC) waveform (whereby an expert identifies~     and scores each breath on the waveform and counts the number of breaths per minute) is~     considered to be a gold standard for measuring RR.~      Being able to record RR, without contact or interference with the patient is appealing~     because it requires minimal patient co-operation, enables measurements even during acute~     respiratory conditions, and may be more representative of real life physiology. Based on a~     principle originally described in the 1980s, a novel instrument that uses a completely~     non-contact system based on structured light plethysmography (SLP) has recently been~     designed by Cambridge University Hospitals Foundation Trust. The device has been refined~     with the development of the Thora-3Di by Pneumacare Ltd, Cambridge. A grid of visible light~     is projected onto the thoraco-abdominal wall and two digital video cameras record changes in~     the grid pattern due to breathing motion. A waveform is produced by the anterior excursion~     of the thoraco-abdominal wall (SLPVol) over time, and a numerical output of RR is provided .~     The present study aims to simultaneously measure tidal breathing with the Thora-3Di and a~     BCI Capnograph 9004 device to compare the Thora-3Di RR output against that of the gold~     standard clinician over-scored end-tidal C02 (COSC) and to assess equivalence of the two~     devices with the aim to establishing the validity of SLP for RR measurement.~   "
52151|NCT02374541|"~     The SaLSA (Screening and Linkage to Services for Autism) study will test whether patient~     navigation can help disadvantaged families obtain earlier diagnosis and treatment for their~     children who have had a positive screening test for autism spectrum disorder. Half of the~     families will be offered help from an autism patient navigator. The other half will receive~     standard care.~   "
52152|NCT02374528|"~     The repairing of various wounds is always a great challenge in burn surgery and plastic~     surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to~     secure the graft to the wound bed, however, there is some evidence to show that irregularly~     contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting~     with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound~     therapy has been advocated as a potential solution to some of these issues. To further test~     the healing rate and safety of this new method, the investigators propose a prospective~     randomized controlled trial to compare this method with traditional bolster dressings~     application in skin-grafting.~   "
52153|NCT02374515|"~     This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection~     rate at colonoscopy. This study involved patients undergoing elective screening or~     surveillance colonoscopy.~      Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before~     undergoing a second colonoscopy by the alternate method. The primary outcome measure was the~     detection rate for adenomas between patients who underwent Endocuff first and patients who~     underwent regular colonoscopy first.~   "
52154|NCT02374502|"~     Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine.~     This results in back pain and stiffness, and causes difficulty with daily activities.~     Physical activity and exercise are key components of the management of ankylosing~     spondylitis, however many adults with ankylosing spondylitis do not meet physical activity~     recommendations. This study aims to investigate the effects of a twelve week intervention~     designed to increase physical activity and exercise in adults with ankylosing spondylitis.~   "
52155|NCT02374489|"~     Primary objective:~      To investigate the objective response rate in patients with ROS1 or ALK over-expressed~     locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378~     Secondary objectives:The progression-free survival ,The disease control rate ,The overall~     survival ,The toxicity profiles , The correlation between clinical outcomes and the~     potential predictive biomarker for tumor response~   "
52156|NCT02374476|"~     This non-randomized study will examine the safety and efficacy of irrigated bipolar~     radiofrequency (RF) ablation in the treatment of ventricular tachycardia (VT) in patients~     for whom standard VT unipolar RF ablation has been unsuccessful. VT is a serious abnormality~     of the heart's electrical system. Ablation is a procedure that cauterizes heart tissue using~     catheters (long tubes that can be moved within or along the outside of the heart).~     Cauterizing the heart tissue is accomplished by using heat to damage the abnormal heart~     tissue that is not working well so that it can stop affecting the rest of the heart.~     Usually, heat is delivered using a unipolar catheter, in which energy travels from the~     catheter tip to a grounding pad. This research study seeks to find out if a bipolar ablation~     catheter, in which the energy travels between two catheter tips on either side of the heart~     muscle, can be used to eliminate the arrhythmia when the unipolar ablation is unsuccessful.~     The hypothesis is that the increased current density and improved rates of transmural lesion~     creation seen with bipolar RF ablation will lead to successful arrhythmia termination with~     minimal or no increased risk of complication.~   "
52157|NCT02374463|"~     Falls are dangerous leading to injuries and even death. The VA has made fall prevention a~     priority, but effective programs only reduce falls by 30%. Tai Chi, a standing exercise~     program, has been effective at improving balance but may not prevent falls. Most falls occur~     during walking when an individual experiences a slip or a trip. Programs that focus on~     walking, stepping, and recovery from a slip may be more effective at fall reduction. This~     study will compare Tai Chi to a novel multimodal balance intervention (MMBI). MMBI focuses~     on standing balance, walking, stepping, strength training, and recovery from a slip. The~     Investigators believe that the MMBI program will be more effective than Tai Chi at improving~     balance and preventing falls in older Veterans and the Investigators will use the results of~     this study to develop a larger study on fall prevention in older Veterans.~   "
52158|NCT02374450|"~     This pre-licensure cohort study will estimate the incidence of protocol-defined potential~     adverse events of special interest (AESI), meningitis and other serious adverse events~     (SAEs) in sub-Saharan African children under 3 years of age. The outcomes of this study will~     provide the baseline data for the post-licensure EPI-MALARIA-003 VS AME (115056) study that~     will evaluate the safety and impact of the RTS,S/AS01E vaccine.~   "
52159|NCT02374437|"~     This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol~     in sixty six (66) healthy male volunteers.~      In each part of the study subjects will be enrolled in the study within 28 days before drug~     administration(s).~      The study will consist of three parts and the subjects will be assigned to three Parts.~   "
52204|NCT02373852|"~     The objective of this study is to collect data on the use of the WIRION system in Patients~     undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).~   "
52163|NCT02374385|"~     Background:~      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it.~      Objectives:~      To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how~     it affects people's immune system.~      Eligibility:~      - Healthy men and women ages 18-65. They must not have a chronic medical condition that~     requires medicine. They must not be a healthcare worker, an animal care worker, or a~     childcare worker, and they must not have a household contact that has a compromised immune~     system, is pregnant, or is under the age of 5 years.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will be randomly assigned to get the vaccine or the placebo.~        -  At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The~          vaccine or placebo will be injected into the upper arm muscle.~        -  Participants will return to the clinic 11 times over the next 6 months. Participants~          will have blood drawn at every study visit. Their mouth will be swabbed and urine~          tested at least four times after vaccination.~        -  For 14 days after vaccination, participants will write down their temperature, any~          symptoms, and any redness at the injection site. They will bring the booklet to each~          study visit.~      All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK~     Health Centre, Halifax, NS.~   "
52164|NCT02374372|"~     The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM.~     This is a prospective randomized study that will compare the two treatment modalities, HD~     and HDF, through economics and pharmaco-economics parameters.~      Patients, who had previously been randomized in the CONTRAST study, will remain in their~     respective group and monitoring will continue. The next patients will be randomized in the~     same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients~     will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare~     cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to~     be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).~      Length and frequency of sessions will be the same in the 2 groups. Blood tests will not~     change and will be the same than those used as routine assessments. Metabolic control of~     patients will be maintained according to the guidelines. Patients will be monitored for a~     minimum of 3 years. A set of demographic and clinical data will be collected from patient~     medical records and throughout the study.~      Biochemical data as part of the usual blood tests of dialysis patients will be collected~     each month as well as will be stored and analyzed information about the annual cardiac~     ultrasounds.~      All events will be scored (hospitalizations, patterns, duration) and the list and cost of~     drugs will be compiled every three months. These data will be useful in the economic~     analysis comparing the two treatment modalities.~   "
52165|NCT02374359|"~     There is few information about the association between supraventricular arrhythmia different~     from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the~     investigators hypothesized that the presence of atrial tachycardia would lead to atrial~     fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.~      The investigators study the association of atrial tachycardia (AT), defined as four or more~     consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in~     192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12~     months for all population~   "
52166|NCT02374346|"~     To evaluate the association of anaesthesia and surgery with postoperative headache in~     elective surgery patients By multiple logistic regression analysis of data collected during~     a six-month period from 446 patients undergoing elective surgery, a prospective single~     centre cohort study in a university hospital. Participants were interviewed preoperatively~     and for five days postoperatively regarding the appearance of headache; while demographics,~     life style, type of anaesthesia and surgery, the anaesthetic drugs administered and~     intraoperative adverse effects in elective surgery patients are recorded.~   "
52167|NCT02374333|"~     This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19~     cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was~     previously treated with cell therapy. This study is targeting pediatric patients aged 1-24~     years with CD19+ B cell malignancies with no available curative treatment options (such as~     autologous or allogeneic stem cell transplantation) who have a limited prognosis with~     currently available therapies and were previously treated with a B cell directed engineered~     cell therapy product.~   "
52168|NCT02374320|"~     The purpose of this study is to investigate whether the use of the study drug (Exparel) is~     safe and effective for treating circulation problems and pain in the hand or fingers.~   "
52169|NCT02374307|"~     The aim of this study is to investigate the effect of a falls-prevention program on quality~     of life, fear of falling, falls and physical function in older people receiving home-help~     services. The participants in the intervention group will perform conduct the Otago exercise~     programme. The participants in the control group will continue with their usual activities.~   "
52170|NCT02374294|"~     In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in~     the surgical site) has been shown to decrease infection rate. Several pressure wounds in the~     coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy~     (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic~     locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the~     infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal~     continuous oxygen therapy. The primary objective of this study is to compare the number of~     surgical site infections associated with perineal surgery within 28 days between subjects~     randomized to receive EPIFLO or Standard of Care~   "
52232|NCT02373488|"~     The aim of this study is to investigate the effect of connective tissue manipulation and~     abdominal massage on severity of constipation and health related quality of life in patients~     with chronic constipation. According to literature, there are studies that investigate the~     effects of abdominal massage on bowel movements. But there is no randomized controlled~     trial, explore the short and long-term effects of different massage technics on chronic~     constipation. Hypothesis of this study is that connective tissue manipulation and abdominal~     massage improves symptoms of constipation and health related quality of life in patients~     suffering with constipation.~   "
52171|NCT02374281|"~     The management of the pain is a constant care concern in neonatal and maternity units. Many~     studies show an interest in the use of sugar solutions to reduce nociception during painful~     events in infants. However, these studies are based mainly on behavioral observation of the~     newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose~     solutions.~      Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a~     subcortical reactivity notably by action via the brain stem. To explore the intensity of~     pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate~     variability (frequency indices whose HFnu) as a peripheral witness of subcortical~     functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of~     crying baby, 3) a composite pain score (DAN score).~   "
52172|NCT02374268|"~     Sarcopenia represents the loss of skeletal muscle and strength that occurs with aging. It is~     a major component of frailty and its effect on daily functioning, falls, and fractures has~     been well documented. Along with the population aging worldwide, the number of people with~     sarcopenia is expected to increase and, thus, contributing to dependency and the anticipated~     increase in health and social care costs. The cause of sarcopenia is multifactorial. Recent~     evidence suggests that some reversibility exists, highlighting the importance of~     intervention modalities. However, the role of nutritional supplementation and exercise~     programs, either individually or in combination, is still uncertain, and further randomized~     controlled trials (RCTs) have been recommended by the International Sarcopenia Initiative.~     Therefore, the investigators plan to conduct a 24-month RCT to compare the effectiveness of~     12-week exercise program alone, combined exercise program and nutrition supplement, and~     non-exercise control group on improving muscle mass, strength and power and physical~     performance in Chinese older people who have sarcopenia defined using the Asian Working~     Group Criteria (AWGC). The investigators hypothesize that compared with the non-exercise~     control group, there will be improvement in muscle strength, power and mass, and physical~     performance in the exercise alone group, and that there will be an additive effect with the~     combined exercise and nutrition supplement group. Chinese older people aged 65 years and~     over will be recruited for a brief screening of sarcopenia and cognitive status. Potential~     subjects will further undertake detailed body composition and biochemical measurements to~     check for their eligibility. Eligible subjects will be randomized to one of the three~     groups: exercise program alone, combined exercise program and nutrition supplement, or~     waitlist control group with the same exercise program offered after 24-week of study~     enrollment. Each group will have 45 subjects. Outcome measurements including muscle~     strength, power and mass, physical performance, instrumental activities of daily living and~     related biochemical measurements will be made at baseline, 12 and 24 weeks.~   "
52173|NCT02374255|"~     The goal of this study is to increase and improve Goals of Care discussions for advanced~     cancer patients by training medical oncologists to conduct these discussions. The~     investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of~     treatment in line with preferences, use of aggressive treatment, and oncologist~     communication skill.~   "
52174|NCT02374242|"~     The purpose of this research project is to test the effectiveness of nivolumab versus~     nivolumab together with ipilimumab for the treatment of melanoma brain metastases.~      Patients are eligible to join this study if they are aged 18 years or above and have been~     diagnosed with melanoma with brain metastases.~   "
52175|NCT02374229|"~     The aim of this prospective randomized study was to evaluate the effectiveness and safety of~     the original ablation procedures ganglion plexus pulmonary artery with simultaneous~     correction of valvular heart disease, complicated by high pulmonary hypertension.~   "
52176|NCT02374216|"~     The purpose of this prospective clinical trial is to investigate and identify factors~     associated with the failure of dental implants within the population rehabilitated with~     dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27,~     Malmö).~   "
52177|NCT02374203|"~     The investigators first aim is to compare the EE and BEE in critically ill patients in~     Taiwan. The second aim of this study is to examine protein requirements in different age~     groups in critically ill patients, and their relationship to factors causing inadequate~     enteral nutrition, duration of mechanical ventilation, newly diagnosed infection and~     duration of intensive care unit (ICU) stay.~   "
52178|NCT02374190|"~     Globally, there is increasing focus on optimization of health system quality. International~     austerity, concerns regarding health care safety and effectiveness, and underlying~     aspirations to continually improve patient experience and outcomes are among the factors~     driving interest in measuring, rewarding, and optimizing quality of care. Care for~     cardiovascular diseases is of particular importance as a leading cause of premature death in~     the UK and across the world. With this as a backdrop, recent studies reveal the persistence~     of significant variations in risk‐adjusted health outcomes across English AMI populations,~     suggesting widespread application of ineffective care. In spite of this evidence, little is~     known on the extent to which modifiable, care‐related factors explain observed variations in~     risk‐adjusted AMI mortality rates. Set in this context, a recent conceptual model -~     emphasizing the influence of in‐hospital care on health outcomes - offers a new opportunity~     to 1) re‐examine the quality of acute treatment for AMI, and 2) reveal the extent to which~     care delivery influences and explains variations in mortality following acute admission.~     This study seeks to use data from the Myocardial Ischaemia National Audit Project (MINAP)~     within a retrospective, observational paradigm to examine the relationship between primary~     care, pre‐hospital patient status, acute clinical management and patient outcomes. Findings~     are expected to give a new perspective to quality of integrated AMI care in England.~   "
52179|NCT02374177|"~     The purpose of this study is to prove the correlation between the post-operative delirium~     (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics~     would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump~     CABG.~   "
52180|NCT02374164|"~     The purpose of this study is to assess the effect of food on the bioavailability of~     febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the~     pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.~   "
52181|NCT02374151|"~     This is a case control prospective study aiming to investigate the accuracy of the~     electrohysterography (EHG) compared to the intrauterine pressure catheter ( IUPC) that is~     commonly used in delivery room. Women in second phase of labor - indicated for insertion of~     IUPC will be asked to participate . Patients that will give their informed consent will be~     connected both to IUPC and EHG. Medical history and demographic parameters will be taken.~     The graphs will be compared and analyzed for its frequency and intensity. Delivery mode and~     fetal well-being will be recorded~   "
52268|NCT02373020|"~     Despite the characterization of many aetiologic genetic changes. The specific causative~     factors in the development of sporadic colorectal cancer remain unclear. This study was~     performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in~     developing colorectal carcinoma.~   "
52182|NCT02374138|"~     Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients~     remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when~     indicated for persistent or uncontrolled asthma, is a critical component of most asthma~     management plans, and other self-management practices such as trigger avoidance are~     similarly related to improved asthma outcomes. Adherence to self-management practices is~     mediated by multiple factors, including psychosocial stress of parents and their children.~      A targeted, culturally appropriate intervention to manage psychosocial stress among the~     parents of young, African American, and socioeconomically disadvantaged urban children with~     asthma who are receiving guideline-based care may improve asthma self-management, and~     therefore asthma outcomes.~      Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional,~     culturally appropriate and community-based asthma intervention to augment existing~     guideline-based best practice. The intervention will target the parents of at-risk, urban,~     African American youth, and will employ individualized psychosocial stress management and~     peer support.~   "
52183|NCT02374125|"~     There is not a clear understanding of the origin of symptoms perceived by patients with~     impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon~     rupture or other pathologies, are present in asymptomatic subjects and subjects with~     symptoms and structural integrity can also be found.~      Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger~     points in the teres major muscle. Travell and Simons reported that the symptoms caused by~     trigger points in this muscle are similar to those experienced by patients diagnosed with~     impingement syndrome, but a literature search provides few results regarding relationship~     between subacromial impingement syndrome and presence of myofascial trigger points in the~     teres major muscle.~      This study aims to provide evidence of the results that can be obtained with a specific~     approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and~     Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that~     still representing both a diagnostic and therapeutic challenge. Secondary objective is to~     compare the outcomes between both techniques to select for each patient the most appropriate~     to their needs and characteristics.~   "
52184|NCT02374112|"~     This study evaluates the effectiveness of medium-term supplementation with creatine to~     improve clinical outcomes in well-defined adult CFS population. Half of the participants~     will receive creatine while the other half will receive placebo.~   "
52185|NCT02374099|"~     The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying~     Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women~     with ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor.~   "
52186|NCT02374086|"~     Angina in the absence of obstructive coronary artery disease is highly prevalent in women,~     and leads to increased risk for major cardiovascular events, including myocardial~     infarction, stroke, and heart failure. Annual mortality rates are ten-fold higher than~     mortality from breast cancer, and the lifetime cost of health care for women with~     non-obstructive chest pain is close to $1 million. Coronary microvascular dysfunction is a~     major etiological feature of this disease, and may contribute to disease progression.~     Despite our general understanding, effective treatment remains elusive. This pilot study~     will test whether regular exercise training can improve/reverse coronary microvascular~     dysfunction in women with angina but no obstructive coronary artery disease.~   "
52187|NCT02374073|"~     Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial~     trigger points in teres major muscle can be associated with this syndrome. The investigators~     objective is to find out if adding manual therapy specifically for teres major trigger~     points can produce better results in these patients.~      Method: A randomized controlled pilot study was carried out. Fifty people were randomly~     assigned to one of two groups: intervention group or control group. Both groups received a~     protocolized physical therapy treatment while the intervention group additionally received~     manual therapy for teres major trigger points.~   "
52188|NCT02374060|"~     To evaluate the relative efficacy of three commonly utilized regional corticosteroids for~     the regional treatment of uveitic macular edema: periocular triamcinolone acetonide;~     intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary~     efficacy measure will be percent change in central subfield thickness as measured by OCT at~     8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative~     effects of the 3 treatment strategies on the duration of treatment effects, requirement for~     additional injections, and adverse effects.~   "
52189|NCT02374047|"~     This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple~     ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)~     or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single~     dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a~     second dose of the study drug after a high-fat meal. Additionally, at 1 dose level,~     CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects~     will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054~     will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days.~     In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to~     assess safety in anticipation of future clinical trials.~   "
52190|NCT02374034|"~     The primary purpose of this experimental study was to determine the acute effect following~     one treatment and the short-term effect after a two-week program of Egoscue corrective~     exercises on chronic knee and hip pain.~   "
52191|NCT02374021|"~     In a randomized controlled clinical trial, investigators will compare the effects on~     [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from~     two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate~     responders (MTX-IRs). Two common RA treatments will be compared: triple therapy~     (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF)~     inhibitor (etanercept or adalimumab, plus background methotrexate).~   "
52269|NCT02373007|"~     The purpose of this study is to show that the modified technique Scopinaro surgery allows a~     better control or reduction of complications often found in nutritional pancreatic and~     biliary derivations, starting from the assumption of a modified technique is as effective as~     Scopinaro classical technique for reducing overweight and control of comorbidities in obese~     patients with grade II and III.~   "
52192|NCT02374008|"~     Purpose:~      The purpose of this study is to evaluate the postoperative analgesic effect of a combined~     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the~     tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a~     mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and~     Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and~     Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and~     reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and~     lethargy compared to the current treatment with local infiltration analgesia.~      Background:~      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven~     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the~     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous~     nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve~     block causes both stunning of the sensory nerves to the knee region and the thighs inward~     leading muscles, and does not affect the patient's mobilization capacity.~      Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a~     well-known local anesthetic. Adrenaline have also been used in other studies, in addition to~     the local anesthetic agent, and has been shown to prolong the effect of the nerve block.~     Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined~     with high dose systemic Dexamethasone has not been systematically investigated in knee~     replacement surgery, and it is not known whether this method will provide better pain~     treatment.~      Method~      The patient can receive one of two treatments, determined randomly:~        -  A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine,~          Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local~          infiltration around the knee joint with placebo medicine (normal saline).~        -  B. Both blocks with placebo medicine (normal saline) and local infiltration around the~          knee joint with activ local anesthetic.~      Neither patient, investigator or staff around the patient will have knowledge of which~     treatment the patient has received.~      The blocks will be placed before the operation and local infiltration around the knee joint~     will be given by the surgeon during the operation.~   "
52193|NCT02373995|"~     Graves' orbitopathy (GO), also known as thyroid eye disease, affects approximately 3 million~     people in Europe with an estimated socioeconomic burden of 6.4 billion euros per annum. GO~     is a complication of Graves' disease which is an autoimmune disease and the commonest cause~     of an overactive thyroid gland. The treatment of GO remains unsatisfactory and the majority~     of patients report long-term impairment of quality of life. The effects of gut derived~     antigens, from micro-organisms and nutrients, on the autoimmune response will be tested in~     the animal model by probiotic and contra-biotic intervention. In the Indigo interventional~     trial the investigators will add to the standard anti-thyroid drug treatment (ATD) a~     specifically designed probiotics (LAB4, Cultech Ltd., West Glamorgan, UK) to assess whether~     it is possible to modify the microbiome in GD patients and improve their immunological~     status.~   "
52194|NCT02373982|"~     This is a Multicenter Observational 1-year retrospective cohort study evaluating the~     predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation~     after pulmonary vein ablation procedure.~      Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of~     the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when~     procedural/follow-up data was prospectively collected.~   "
52195|NCT02373969|"~     Verify the changes in coagulation system during total knee replacement surgery with~     tranexamic acid single bolus infusion.~   "
52196|NCT02373956|"~     The main objective of this study is to document the effectiveness of a honey-based medical~     device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical~     device will be judged according to the evolution of the surface of the wound at the end of~     12 weeks of treatment.~   "
52197|NCT02373943|"~     The main objective of this human trial is the demonstration that β-carotene in fortified~     maize has good bioavailability as a plant source of vitamin A and that when humans ingest~     the biofortified product retinol levels are higher than when they ingest non biofortified~     white maize.~   "
52198|NCT02373930|"~     Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration~     of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir~     (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1~     reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection.~     This study is aimed to evaluate the relative bioavailability and food effect of single doses~     of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams~     (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single~     dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult~     subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label,~     3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of~     up to 4 test formulations relative to the reference single entity products administered in~     fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3~     distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of~     up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2,~     DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the~     reference treatment from Part 1 co-administered under fasted conditions. This study will~     consist of a screening visit, three treatment periods each with a single dose of study drug~     separated by a washout of at least 9 days and a follow-up visit. The total duration of~     participation of a subject in this study will be approximately 10 weeks.~   "
52199|NCT02373917|"~     In this study the investigators will collect Blood,sputum and saliva samples for~     Characterization of Methylation Patterns in lung Cancer.~   "
52200|NCT02373904|"~     The purpose of this study is to collect safety and performance data of the Photodynamic Bone~     Stabilization System (PBSS) when used for the treatment of painful impending and actual~     fractures of the humerus secondary to metastatic cancer.~   "
52201|NCT02373891|"~     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when~     orally administered as a salt composed of an acid-base as a compound that was synthesized by~     and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively~     applied to the bronchial or lung tissue and inhibit the activity of phospholipase~     bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar,~     leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent~     anti-inflammatory activity, bronchial was celebrated by reducing the bronchial~     hyperreactivity to normal state is allowed to recuperate or extended.~      It was developed to improve compliance improve pharmaceutically Acebrophylline that intake~     twice daily 100mg to Surfolase CR that intake once daily 200mg~   "
52202|NCT02373878|"~     The purpose of this study was to evaluate the impact of telecoaching conducted by a~     counselor trained in motivational interviewing paired with a portion control device for~     obese patients receiving care in a certified patient-centered medical home. The~     investigators will conduct a randomized, controlled clinical trial evaluating the~     effectiveness of a telecoaching intervention with a portion control device.~   "
52203|NCT02373865|"~     This exploratory double blind randomized active controlled study is designed to assess the~     effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage~     of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients~     inadequately controlled on metformin monotherapy.~   "
52205|NCT02373839|"~     Preeclampsia is an important disease that develops during pregnancy and it is one of the~     main contributors to maternal and fetal complications.~      The only known definitive treatment is delivery. Although delivery is always appropriate for~     the mother, it might not be the best for a very premature neonate.~      In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It~     is also well established that before 34 weeks an expectant management confers perinatal~     benefit with minimum amount of additional maternal risk. There is then an area of~     uncertainty between 37 and 37 weeks. This is why in this period it is a clinical need to~     select high risk patients of complications that will benefit from labor induction, and~     differentiate them from low risk patients that can be manage expectantly until 37 weeks.~      Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with~     preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome~     and requirement of delivery.~      Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit~     from labor induction and those where delivery can be delayed until 37 weeks with low risk~     for maternal complications.~   "
52206|NCT02373826|"~     During coronary angiography, the lumen of the arteries is imaged but intravascular~     ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion~     length and luminal reference diameter. We aimed to investigate the accuracy, feasibility,~     safety and value of a novel method for co-registration of IVUS and coronary angiographic~     images.~   "
52207|NCT02373813|"~     The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to~     methotrexate monotherapy on maintenance of remission in subjects with Rheumatoid Arthritis~     who were on etanercept plus methotrexate therapy.~      This is a multicenter, randomized withdrawal, double-blind controlled study in subjects with~     Rheumatoid Arthritis on etanercept plus methotrexate therapy who are in very good disease~     control for 6 months prior to study entry. The study will consist of a 30-day screening~     period, a 24-week open label run-in period, a 48-week double-blind treatment period and a~     30-day safety follow-up period.~      Approximately 720 subjects will be enrolled and approximately 500 subjects will be randomly~     assigned in a 2:2:1 ratio to one of three treatment groups: etanercept 50 mg weekly by~     subcutaneous injection plus oral placebo for methotrexate (n = 200), oral methotrexate 10 to~     25 mg weekly plus placebo for etanercept (n = 200) and etanercept 50 mg weekly by~     subcutaneous injection plus oral methotrexate 10 to 25 mg weekly (n = 100).~   "
52208|NCT02373800|"~     The primary objective of this study is to determine if a cervical hardness score (determined~     by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian~     for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction~     mode (ocytocin alone or with an intravaginal device releasing PGE2).~   "
52209|NCT02373787|"~     A 5-year clinical investigation on creos xenoprotect~   "
52210|NCT02373774|"~     The purpose of this study is to determine if performing an ultrasound to identify the space~     to insert the needle before performing a lumbar puncture will improve success of the~     procedure and patient safety.~   "
52211|NCT02373761|"~     This study seeks to find out if the tibial and patellar components of the Stryker Triathlon~     Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.~   "
52212|NCT02373748|"~     The purpose of this study is to evaluate the movements performed according to the BioGaming~     YuGo software, and verify that they are rehabilitation movements.~   "
52213|NCT02373735|"~     The purpose of this study is to investigate the effect of stroke volume variation (SVV)~     guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.~   "
52214|NCT02373722|"~     This randomized clinical trial studies how well website application (web app) based~     education and text messaging works in improving skin wound care in patients undergoing Mohs~     surgery (a surgical procedure used to treat skin cancer). Website application and text~     messaging based education may help patients stick to wound care instructions before and~     after surgery, lower anxiety level, and may help monitor their activity.~   "
52215|NCT02373709|"~     To elucidate the disease pathway of perinatal depression by identifying genetic variants~     which could play a role in predisposing to the condition and/or lead to better understanding~     of the pathogenesis of the condition. This is achieved by investigating for associations~     between oestrogen receptor genetic variants and perinatal depression.~   "
52216|NCT02373696|"~     Incidence and risk factors for persistent post surgical pain after Caesarean section are~     investigated. Demographic, psychophysical testing and genetic screening factors are~     performed in the perioperative period. Phone survey is performed to investigate the~     incidence of persistent post surgical pain after Caesarean section.~   "
52217|NCT02373683|"~     The aim of this prospective pilot study is to determine the effect of heliox delivered via a~     proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system~     (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.~   "
52218|NCT02373670|"~     A feasibility study randomizing participants (parents of children age 2-5 years old) to~     receive either education or a parent mentor with the aim of improving health behaviors and~     improving their body mass index z-score.~   "
52231|NCT02373501|"~     To evaluate the effects of extra-abdominal repair of the uterine incision compared to~     intra-abdominal repair, and to study is there superiority of one technique over the other in~     terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post~     operative ( until day 4 after operation ) measurements , secondary outcomes, long-term~     outcomes and subjective outcomes.~      PRIMARY OUTCOMES:~      Intra - operative ( during the operation up to 4 hours from anesthesia )~        -  nausea and vomiting~        -  intraoperative hypotension~        -  intraoperative pain~      Post operative ( 4 hours from anesthesia and until release from hospital )~        -  Blood transfusion~        -  Venous thromboembolism~        -  Febrile Morbidity~        -  Endometritis~        -  Wound Infection~        -  Death~      Subjective measures:~        -  complain of pain 1-10 on day 1 post operative~        -  time until walking~        -  number of Days until having bowel movement~        -  overall satisfactory~      SECONDARY OUTCOMES:~        -  Operative time~        -  Estimated blood loss ( ebl ) - hemoglobin levels~        -  Hospital stay~   "
53580|NCT02355795|"~     The aim of the current study is to evaluate the effects of diets with three levels of~     dietary fat on weight change and related cardiometabolic risk factors in a 6-month~     randomized controlled-feeding trial.~   "
52219|NCT02373657|"~     Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter~     Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha~     Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We~     have found that repeated mass administration of oral azithromycin can greatly reduce the~     prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate~     infection. The World Health Organization recommends not only antibiotics for control of~     trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial~     hygiene promotion, and Environmental improvements such as latrines and water points).~     Trachoma is more common in villages and households with poor access to water and latrines,~     so improving the public health infrastructure is thought to be important for limiting~     transmission of trachoma. However, there is very little evidence to support the efficacy of~     installing new water points for trachoma. There has been only one previous attempt to study~     the role of hand dug well installation for trachoma control, and this study, conducted in~     Niger, found that installing wells was not effective. We now propose a project to improve~     the public health infrastructure of Goncha Siso Enese woreda by helping with the~     construction of water points (e.g., hand-dug wells) and providing hygiene education, in~     order to determine whether improving access to water and hygiene information will be~     effective for control of trachoma and soil-transmitted helminths.~   "
52220|NCT02373644|"~     The purpose of the research project is to compare the effectiveness of non-thrust~     mobilization and exercise versus thrust manipulation and dry needling in patients with~     sacroiliac dysfunction. Physical therapists commonly use both approaches to treat sacroiliac~     joint dysfunction, and this study is attempting to determine if one approach is more~     effective than the other.~   "
52221|NCT02373631|"~     The purpose of this research is to compare the effectiveness of conventional physical~     therapy (manual physical therapy, exercise, range of motion, and stretching) versus~     conventional physical therapy combined with dry needling in patients with knee~     osteoarthritis (OA). Physical therapists commonly use conventional physical therapy~     techniques and dry needling to treat knee OA, and this study is attempting to find out if~     the addition of dry needling to conventional physical therapy has an equal, greater, or~     lesser effect than conventional physical therapy alone.~   "
52222|NCT02373618|"~     The purpose of this research is to compare patient outcomes following treatment of plantar~     fasciitis with conventional physical therapy (stretching, strengthening, ultrasound, manual~     therapy, and cryotherapy) and conventional physical therapy plus dry needling. Physical~     therapists commonly use conventional physical therapy techniques and dry needling to treat~     plantar fasciitis, and this study is attempting to find out if the addition of dry needling~     to conventional physical therapy is more effective than conventional physical therapy alone.~   "
52223|NCT02373605|"~     The purpose of this research is to compare two different approaches for treating patients~     with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation~     and dry needling. Physical therapists commonly use all of these techniques to treat~     cervicogenic headaches. This study is attempting to find out if one treatment strategy is~     more effective than the other.~   "
52224|NCT02373592|"~     This study aims to implement daily temperature measurements of feet complemented by SMS and~     voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at~     high risk of ulceration.~      Design: Physician-blinded, randomized, 18-month trial.~      Setting: Diabetes outpatient clinics from two public hospitals~      Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes~     mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in~     both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system~     as specified by the International Working Group on the Diabetic Foot, (5) have an operating~     cell phone or a caregiver with an operating cell phone, and (6) have the ability to provide~     informed consent.~      Hypothesis: The investigators hypothesize that implementation of an enhanced intervention~     that combines daily temperature measurement for the reduction of diabetic foot ulcer with~     SMS and voice messaging will improve patient measurement compliance and reduce diabetic foot~     ulcers in a middle income country.~   "
52225|NCT02373579|"~     Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible~     protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical~     and biochemical parameters.~   "
52226|NCT02373566|"~     In this study the efficacy of an acellular dermal template (Novomaix), combined with split~     thickness skin grafts, for use in patients with full thickness skin defects, is tested.~     Results will be compared intra-patient with those obtained after conventional treatment with~     split thickness skin grafts. The investigators expect this treatment to provide better~     outcome regarding scar quality.~   "
52227|NCT02373553|"~     MB Children maintains the same postural pattern in preoperative and postoperative~     adenotonsillectomy? The age influences the incidence of more exacerbated postural changes?~     The proposed early physiotherapy intervention can minimize future functional deficits?~     Trying to answer some of these questions, the objective of present study is to investigate~     the initial kinematics of the shoulder girdle, cervical and thoracic spine in MB children~     pre and post adenotonsillectomy and then evaluate the effects of a physical therapy~     intervention program for MB children who persisted with postural changes.~   "
52228|NCT02373540|"~     The purpose of this study is to obtain real-world clinical outcome data for the Algovita~     Spinal Cord Stimulation system when used, on-label, according to the applicable directions~     for use.~   "
52229|NCT02373527|"~     The purpose of this study is to compare the safety and effects of fasting or not fasting~     overnight before a cardiac catheterization (heart procedure). The study will compare~     patients who have nothing to eat after midnight before the procedure to those who are~     allowed to eat or drink before the procedure.~   "
52230|NCT02373514|"~     Patients presented with dysmenorrhea composed the study population. One gram paracetamol and~     50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing~     dysmenorrhea in emergency department.~   "
52284|NCT02372812|"~     A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone~     on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing~     mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this~     dose were also assessed for.~   "
52233|NCT02373475|"~     Postoperative pulmonary complications are main cause of overall perioperative morbidity and~     mortality in the patients following general anesthesia. A protective ventilation strategy~     refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with~     positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective~     ventilation has been considered the optimal practice in patients suffering from the acute~     respiratory distress syndrome (ARDS). However, few human studies have assessed how to~     ventilate healthy lungs in patients undergoing general anesthesia, especially in prone~     position. Prior studies reported that in the patients undergoing major abdominal surgery in~     supine position, intraoperative lung protective ventilator settings had the potential to~     protect against pulmonary complications. Therefore, the investigators planned this study to~     better specify the effect of intraoperative protective ventilation in surgical patients in~     the prone position.~   "
52234|NCT02373462|"~     To study the effect of olmesartan on walking distance and quality of life in peripheral~     artery disease patients with hypertension treated For intermittent claudication.~   "
52235|NCT02373449|"~     Neuropathic or nerve injury related pain (NP), an extremely unpleasant condition that is~     difficult to treat, often has a severe, persistent, and unremitting course. Conventional~     treatments are often ineffective in relieving NP. Recently, the investigators have developed~     a cost-efficient regimen involving use of low dose infusions of ketamine for treating~     neuropathic pain in patients in whom oral medications have failed. We have observed~     excellent benefits in many of these patients. However, this treatment requires titration and~     monitoring during the infusion and currently it is not possible to predict which patients~     will benefit from this intervention. The investigators have shown that functional magnetic~     resonance imaging (fMRI) of the brain can be used as a tool to predict relief of pain and to~     assess the effect of treatment in some chronic pain conditions. This innovative project~     involves development of an fMRI-guided treatment with intravenous ketamine in patients with~     NP. This study aims to analyze patterns of changes in fMRI of the brain, before and after~     infusion of ketamine and to correlate the changes with pain intensity. The information from~     this study will help to deliver this therapy earlier to those patients who are most likely~     to benefit from ketamine.~   "
52236|NCT02373436|"~     The hemiparesis is one of the most important sequelae of stroke, and generally have greater~     impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater~     amount of use and most affected UL movement quality, studies have described as a~     rehabilitation technique constraint Induced Therapy (CIT). The objectives of this study will~     evaluate the effect of CIT in severe hemiparetics patients in the quantity and quality of~     movement UL and grip strength, and the relation between the scapular kinematics and trunk~     with the quality of movement measured clinically. Randomized crossover study with systematic~     reviews in AB mode, where A is the baseline to the evaluation of the period of 2 weeks~     without any intervention and B, the two-week period with intervention. One group will start~     with the intervention period (BA) and the other group with the period without intervention~     (AB). The intervention will be for 3 hours / day, 5x / week for two weeks and use of wrist~     and fingers restriction UL unaffected. To evaluate the quality and quantity of UL use in~     real environment will be used to Motor Activity Log (MAL), to quantify the motor skill the~     Wolf Motor Function Test (WMFT), the 3D movement of the scapula and trunk during arm~     elevation and functional activities of the UL will be measured by the electromagnetic~     tracking system and grip strength by hand dynamometer.~   "
52237|NCT02373423|"~     A clustered-randomized controlled trial in which 45 food companies are the unit of~     randomization. The intervention companies will receive an advocacy program which comprises~     of commonly used advocacy actions, incorporating a theory of change model. The control~     companies will have no specific intervention targeted at them. The aim of this study is to~     quantify the effects of advocacy delivered by a local non-government organization on the~     salt content of food products produced or marketed by companies in Australia.~   "
52238|NCT02373410|"~     The purpose of this study is to analyze the accuracy of needle insertion and the discomfort~     during different ergonomic conditions faced by anesthesiologists during spinal anesthesia.~     In particular,the investigators intend to compare the angles between the patients' back and~     the inserted spinal needle in the coronal plane at different operating table heights.~   "
52239|NCT02373397|"~     The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120)~     in improving wound healing and nerve regeneration in the anterior cornea, in a patient~     population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal~     erosions.~   "
52240|NCT02373384|"~     The aim of the study is to evaluate the predictors of success of oral dissolution therapy in~     radiolucent renal stones in a large series of patients from a tertiary referral center in~     order to define the optimum case scenarios where oral dissolution therapy could be~     implemented.~   "
52241|NCT02373371|"~     The main objective of this study is to compare efficacy and safety of Metvix® natural~     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in~     subjects with mild actinic keratoses (intra-individual comparison)~   "
52242|NCT02373358|"~     Neuroscience evidence indicates that trauma is stored in the body, that trauma impairs the~     language centers found in the brain, and that emotion centers in the brain tend to override~     cognitive centers in the brain following trauma. Most evidence-based models to date to treat~     trauma using cognitive therapy, which does not fully resolve symptoms, particularly in the~     case of complex trauma. This evidence has led to researchers to call for alternative,~     body-oriented treatments that target trauma from the lowest levels of regulation up to~     higher levels of regulation in the brain. Yoga has been proposed as one such intervention.~     Recent research has investigated the benefits of yoga to treatment adult females who have~     experienced PTSD, but only anecdotal, descriptive, and qualitative data is available for~     studies of yoga with adolescents. This mixed methods study seeks to generate quantitative~     data demonstrating whether or not the 6-week group yoga intervention leads to decreases in~     general mental health and trauma-specific symptoms and qualitative data regarding the~     components of the intervention the participants found both helpful and unhelpful.~   "
52285|NCT02372799|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major~     depressive disorder.~   "
52243|NCT02373345|"~     The purpose of the present study is to determine the association between factors known to be~     associated with the development of chronic low back pain (psychological and biological) and~     the evolution of functional disability in individuals with a history of low back pain. To do~     so, 100 individuals with a history of nonspecific low back pain will be followed over a~     period of 18 months. During this time frame, participants will be evaluated three times in~     the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance~     thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these~     participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for~     functional disability and pain intensity levels of their low back pain as well as for~     psychological symptoms usually associated with the development of chronic low back pain. It~     is hypothesized that high psychological symptoms measured initially will be associated with~     high functional disability throughout the study .~   "
52244|NCT02373332|"~     This study investigates the potential protective effects of altering fatty acid in the~     platelet as a method for prevention of platelet activation and thrombosis in type 2 diabetes~     mellitus. Fatty acids (omega-3 and omega-6) and their oxidized lipids will be evaluated for~     protection from agonist-mediated platelet activation in platelets from type 2 diabetics and~     healthy controls.~   "
52245|NCT02373319|"~     The aims of this study are (1) to validate a self-screening method for cardiovascular (CV)~     risk that does not require the supervision of a health professional (including~     self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and~     self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From~     these data, the investigators will generate personalized recommendations based on the best~     available evidence. The investigators will also analyze whether this innovative approach~     improves adherence to preventive recommendations for cardiovascular and other chronic~     diseases.~   "
52246|NCT02373306|"~     Implantable cardioverter-defibrillator (ICD) is a widely used and effective therapy which~     reduces the risk of cardiac death in many cardiac diseases, both implanted for secondary and~     primary prevention. It is known that recurrent arrhythmias and ICD discharges have adverse~     prognostic significance. Parameters that would identify patients who are at increased risk~     of arrhythmias and appropriate ICD interventions would be of clinical value. The aim of the~     study is to evaluate the usefulness of non-invasive programmed stimulation (NIPS) in~     determining the likelihood of life-threatening arrhythmic events in patients with ICD.~   "
52247|NCT02373293|"~     This is an epidemiological, observational, prospective, multicentric study in 400 adult~     patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value~     of the antithrombin III in the development of moderate or severe acute pancreatitis.~   "
52248|NCT02373280|"~     To compare the eradication success rate between 10-days sequential therapy and 7-days~     tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.~   "
52249|NCT02373267|"~     Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage~     and/or organ failure in different entities of thrombotic microangiopathies (TMA)~   "
52250|NCT02373254|"~     This study is being conducted to evaluate whether NSAIDS are more or less effective in bone~     healing than opioids in acute fracture pain. Participants will be randomized to one of three~     groups for first line treatment of pain related to the fracture.~   "
52251|NCT02373241|"~     Untreated hypertension and renal injury are risk factors for increased morbidity and~     mortality in sickle cell disease, yet early markers of progressive disease have not been~     identified and therapies to prevent the development of adverse cardiovascular outcomes have~     not been defined. Circadian blood pressure, as defined by 24 hour blood pressure monitoring,~     is more accurate than clinic blood pressure in defining secondary hypertension and abnormal~     nocturnal blood pressured dipping and nocturnal hypertension have been linked to progressive~     renal disease in other diseases.~      Methodology/Aims: A randomized feasibility trial of losartan will be conducted among~     adolescent HbSS and SB0 thalassemia patients (11-19 years) with abnormal nocturnal blood~     pressure dipping. During this six month feasibility trial, two dosing strategies of losartan~     (titrated to keep clinic BP <95th percentile vs. <75th percentile) will be analyzed for~     safety and effect on restoring normal circadian blood pressure.~      A prospective cohort study among HbSS and SB0 thalassemia patients (6-19 years) will also be~     conducted to evaluate the incidence of hypertension and role of monitoring potential~     biomarkers of kidney injury and hypertension. Cohort participants will undergo annual~     evaluations of hypertension(24 hour blood pressure monitoring for participants ≥ 11yrs,~     clinic BP in all participants) and markers of kidney injury/hypertension.~      Expected Results: At the completion of the feasibility trial, vital background information~     will be obtained to design a definitive multicenter trial of hypertension in sickle cell~     disease. At the completion of the cohort study, the incidence of pediatric hypertension will~     be identified and the role for monitoring blood and urine biomarkers will be better~     understood.~      As therapy for patients with renal failure is dismal, it is imperative that SCD patients at~     risk are identified early and that therapeutic trials are conducted that prevent~     progression.~   "
52252|NCT02373228|"~     Hearing impaired persons suffer from inferior music perception with and without hearing~     aids. Hearing aids, however, are primarily designed to improve speech intelligibility not~     music enjoyment. This study investigates the potential benefit of signal processing~     strategies that are optimized for music. The purpose of this study is to improve music~     compression for hearing impaired people.~   "
52253|NCT02373215|"~     This is a single-center clinical research study with the purpose to evaluate the safety,~     tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in~     end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting~     pruritus.~   "
52254|NCT02373202|"~     Primary Objective:~      To document the long-term safety of sarilumab added to non-methotrexate (non-MTX)~     disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.~      Secondary Objective:~      To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.~   "
52270|NCT02372994|"~     This project will pilot and test a new online communication tool, Loop, developed within a~     research framework with participatory and user-centred design. This pilot trial focuses on~     advanced cancer as an example of complex care. Cancer care involves many healthcare~     providers, spanning hospital to home. There is no organized way for them to communicate.~     Loop is a practical tool for ongoing collaboration in the patient's actual team of care that~     engages patients. The study will answer the questions: does Loop improve communication~     efficiency, engage patients and family physicians, and show early benefits in quality and~     health care costs?~   "
52286|NCT02372786|"~     The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream~     and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single~     laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.~   "
53594|NCT02355613|"~     Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife~     radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients~   "
52255|NCT02373189|"~     Nearly 50% of U.S. veterans report they experience pain on a regular basis. This chronic~     pain often co-occurs with other disorders including post-traumatic stress disorder (PTSD),~     depression, anxiety and insomnia. A common approach to treating chronic pain is opioid~     analgesics, which are not always effective, and increasingly associated with abuse and~     misuse. Thus, there is an urgent need to develop readily available, safe, and practical~     complementary nonpharmacological approaches to manage chronic pain in U.S. veterans. Chronic~     pain is a multidimensional phenomenon, inter-related with many factors, including negative~     mood and poor sleep. The central circadian clock, in the suprachiasmatic nucleus in the~     hypothalamus, is well recognized to regulate both mood and sleep, and even small delays~     (shifts later) in circadian/sleep timing are associated with depression and disrupted sleep.~     These results suggests that later circadian/sleep timing may be a modifiable risk factor for~     pain. Thus, a self-administered morning bright light treatment at home may be a potentially~     efficacious adjunctive strategy for managing chronic pain. This R34 grant will develop a~     morning bright light treatment to help manage chronic pain and improve PTSD symptoms,~     depression, anxiety and sleep in U.S. veterans. Patients will have 7 baseline days at home,~     followed by a baseline pain sensitivity assessment and home circadian phase assessment (dim~     light melatonin onset). Following an instructional home visit, patients will then~     self-administer morning bright light treatment for 6 days, followed by reassessments of pain~     sensitivity and circadian phase. Assessments will be repeated after another 7 days of~     morning bright light treatment. Pain, mood and sleep (wrist actigraphy) will be assessed~     daily throughout baseline and treatment. Pain, mood and sleep will also be rated by veterans~     daily during a 1 month follow up after cessation of light treatment. This study will~     determine the feasibility, acceptability and efficacy of bright light treatment in a sample~     of U.S. veterans experiencing chronic low back pain.~   "
52256|NCT02373176|"~     [14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and~     Excretion Following Oral Dosing to Healthy Male Subjects.~      Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and~     PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of~     [14C]PRC-4016 to healthy male subjects.~      To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal~     excretion of radioactivity.~      To examine the profile of metabolites in plasma, urine and faeces. To further assess the~     safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.~   "
52257|NCT02373163|"~     This trial is designed to:~        1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel~          blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among~          hypertensive subjects who live at sea level, at medium altitude above sea level and at~          high altitude above sea level.~        2. To test whether diferentes exist in the response to therapy among subjects who live at~          different altitude above sea level~        3. To assess the hemodynamic characteristics of hypertension in populations that live at~          sea level, at medium altitude above sea level, and at high altitude above sea level.~   "
52258|NCT02373150|"~     This study will assess the pharmacokinetics of single and repeated doses of imeglimin in~     healthy Japanese subjects, and the safety and tolerability of single and repeated doses of~     imeglimin in healthy Japanese subjects.~   "
52259|NCT02373137|"~     The purpose of this study is to compare visual acuity outcomes of two types of endothelial~     keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2)~     Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be~     randomized to have DSAEK and the other half will have DMEK.~   "
52260|NCT02373124|"~     This study evaluates the feasibility of a treatment paradigm that involves naturalistic~     cocaine use opportunities in the context of psychotherapy aimed at utilizing these~     opportunities therapeutically.~   "
52261|NCT02373111|"~     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the~     intrinsic aging process, and accounts for the majority of age-associated changes in skin~     appearance. Reactive oxygen species (ROS) play a key role in UV-induced skin damage and~     diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous~     skin antioxidants as well as plant-derived or synthetic compounds have been examined.~      Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were~     well-known photo-protective agents with strong antioxidant activity. Several studies have~     revealed that supplementation of astaxanthin effectively protect skin against UV damage~     through free radicals.~      In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step~     toward skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic~     and antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a~     kind of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1~     effectively.~      The present study is designed to take isoflavone combined with astaxanthin to maximize their~     anti-aging ability and objectively measure the effects of the mixture on facial wrinkles,~     hydration, and elasticity.~   "
52262|NCT02373098|"~     The main purpose of this study is to measure the serum levels of cytokines and chemokines~     that are known to increase during multiple sclerosis relapses.~      Cytokines are a broad and loose category of small proteins that are important in cell~     signaling.~      The second purpose of the study is to test the cytokine/chemokine changes measured in the~     3rd and 6th months on the efficacy parameters.~   "
52263|NCT02373085|"~     Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients~     (KTR) is controversial. The investigators performed a comparative, parallel-group,~     randomized, open-label study to assess, in a real clinical setting, the feasibility of and~     benefit derived from systematic search and antimicrobial treatment of all episodes of AB.~   "
52264|NCT02373072|"~     This is a study with two sequential cohorts, each with three treatment periods. Single doses~     of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose~     projected to be under the current limits for drug concentration. Each cohort will aim to~     achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary~     endpoint is MDS-UPDRS part III.~   "
52265|NCT02373059|"~     A research study to enhance clinical discussion between patients and pharmacists using a~     shared decision making tool for type 2 diabetes or usual care.~   "
52266|NCT02373046|"~     This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose,~     crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion~     (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets~     in healthy subjects under fasted conditions.~   "
52267|NCT02373033|"~     This study evaluates the effects of folate-rich foods regarding improvement of folate status~     compared with folic acid supplement. A randomized, parallel intervention trial with two~     active groups (folate-rich foods or folic acid supplement) and one control group (apple~     juice - 0 µg/d folate) was executed over 12 weeks.~   "
52281|NCT02372851|"~     The purpose of this study is to determine whether the use of a point-of-use water filtration~     technology can reduce the Arsenic content in drinking water and reduce the Arsenic body~     burden.~   "
52271|NCT02372981|"~     Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise~     the drawbacks of the golden standard of haemorrhoidal treatment, conventional~     haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal~     artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus~     prevent the haemorrhoidal zone from being part of the continence system. Apart from~     inappropriate application of this surgical alternative for higher grade haemorrhoids, high~     recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation~     technique itself. This is a prospective randomised controlled trial to evaluate the efficacy~     of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with~     symptomatic grade III haemorrhoids.~   "
52272|NCT02372968|"~     The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic~     profiles, body composition, food habits and physical activities on a large cohort of human~     volunteers. Analysis of collected data will serve to measure the variability of the data and~     to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor~     the metabolic and physiologic effects of foods.~   "
52273|NCT02372955|"~     Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in~     patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers~     clinic SBP is unknown. The primary objective of the study is to determine the effect of~     dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index~     (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion,~     and Intravascular volume status will be recorded. The study will involve 21 subjects for a~     duration of 16 weeks.~   "
52274|NCT02372942|"~     Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction~     of the 30% of preterm deliveries versus the use of progesterone, in specific selected~     patients, with consequent improvement in neonatal outcome.~      Secondary endpoint will be compare antibacterial and anti-inflammatory activity of~     lactoferrin by evaluation of systemic biochemical and urinary markers.~   "
52275|NCT02372929|"~     The primary objective of this study is to document all cases of EUS in patients with~     esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor~     correlates with locally advanced disease stage at Endoscopic Ultrasound.~   "
52276|NCT02372916|"~     Given the aging population who will be affected by wet AMD and lack of effective GA~     treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in~     AMD patients with GA, particularly the possible risk of GA development and enlargement. This~     potential adverse effect has significant implication in the discussions with patients~     regarding the risks and benefits of AMD treatment and injection frequency. While monthly~     injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the~     risk of GA enlargement may offset this benefit in visual acuity.~      Previous studies assessed the association between intravitreal ranibizumab injections and de~     novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012.,~     Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the~     best of the investigators knowledge, there has been no prospective study assessing the~     association between intravitreal ranibizumab injections and rate of GA progression in~     patients with pre-existing GA. There is also no prospective study comparing the~     morphological features of GA between patients who are receiving intravitreal injections and~     those who are not, nor the concordance of GA enlargement rate between the 2 eyes among~     patients receiving and not receiving treatment.~   "
52277|NCT02372903|"~     One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully~     understood. The detection of mast cells in the endometriosis lesions supports the hypothesis~     that mast cell degranulation may contribute to development of pain and hyperalgesia.~      N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation~     and pain, controlling mast-cell activation. The aim of the study is to investigate the~     efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic~     patients with endometriosis.~   "
52278|NCT02372890|"~     In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in~     addition to free resection margins following surgical resection of the primary tumor is an~     important prognostic factor, and may impact planning of surgery as well as of radiotherapy.~     Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially~     small lymph node metastases.~      Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and~     neck PET/CT acquisitions promise improved detection of lymph node metastases in head and~     neck squamous cell carcinoma (HNSCC). This prospective study aims to determine the~     sensitivity and specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating~     PET/CT with histopathology after neck dissection. HR PET/CT may have a relevant impact on~     the therapeutic concept, and the planning and dose prescription of radiotherapy.~   "
52279|NCT02372877|"~     The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell~     Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle~     cell disease.~   "
52280|NCT02372864|"~     Short Rationale: Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing~     ovarian cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective in~     detecting ovarian cancer in an early and curable stage. Women who underwent RRSO experienced~     bothersome menopausal symptoms and worsening of sexual functioning related to acute surgical~     menopause. Hormone replacement therapy (HRT) will mitigate some of the RRSO induced~     menopausal complaints, however it does not reduce the complaints to a premenopausal level~     and the sexual symptoms are not alleviated. Mindfulness interventions were found to improve~     sexual functioning and alleviate menopausal symptoms in various populations. It has not been~     investigated whether mindfulness-based stress reduction (MBSR) is effective in mitigating~     the RRSO-induced menopausal complaints in BRCA1/2 mutation carriers and if this effect is~     sustained over a longer period of time.~      Objective: To examine the effect of MBSR training on the menopause-specific quality of life~     in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints.~      Study population: Female BRCA1/2 mutation carriers who were younger than 52 years at the~     time of RRSO reporting two or more moderate to severe menopause related complaints after~     undergoing RRSO.~      Study design: Prospective randomized controlled trial with a follow-up time of twelve months~     conducted at the University Medical Center Groningen (UMCG)~      Intervention: Eight-week MBSR training consisting of a weekly class of two and half hours~     and a full retreat day. Furthermore participants are asked to practice mindfulness exercises~     at home for 45 minutes, six days a week.~      Main study parameters/endpoints: Menopause specific quality of life score measured by the~     Menopause-specific quality of life questionnaire (MENQOL). Nature and extent of the burden~     and risks associated with participation, benefit and group relatedness: There are no risks~     associated with taking part in a MBSR training or filling out the questionnaires that will~     be used in this study. The content of the questionnaires concerns intimate matters and could~     be considered burdensome. A possible benefit for the participants of the MBSR training is~     that participants will be more able to cope with their complaints after RRSO. The group~     relatedness is reflected in the fact that RRSO is specifically performed in women with a~     hereditary risk of ovarian cancer such as BRCA1/2 mutation carriers.~   "
52288|NCT02372760|"~     Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when~     indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory~     tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given~     the possible side effects of cough of varying severity this procedure can be uncomfortable~     to patients, some would even shy away from having a bronchoscopy even when it's medically~     indicated.~      Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as~     compared to the conventional way of injecting the anesthesia into the bronchoscopy working~     channel. The investigators aim to conduct this study with the hope of improving patient~     care, providing comfortable procedures, helping more patients opt in for bronchoscopy when~     indicated.~   "
52289|NCT02372747|"~     To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II~     anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).~   "
52290|NCT02372734|"~     The research study will investigate the longitudinal cognitive outcomes in subjects admitted~     as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be~     contacted 2-15 years after their incident admission in order to solicit responses to a~     functional and cognitive quality of life survey. Children admitted during the same time~     frame that did not have kidney injury will also be surveyed.~   "
52291|NCT02372721|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated~     in the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
52292|NCT02372708|"~     To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma~     by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and~     carry out monitoring on related immunological parameters of the patients.~      72 patients with stage III (b or c) or stage IV skin (which could not be excised by~     operations) malignant melanoma were treated by combining simple semiantigen DNP in situ~     immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg~     regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory~     cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was~     monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was~     observed, and results of clinical follow-ups were also examined.~   "
52293|NCT02372695|"~     To provide evidence based prospectives of the potential benefit effects of paricalcitol, an~     analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis~     (vessels), atherosclerosis and vascular calcification.~   "
52294|NCT02372682|"~     Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric~     population are limited and inconclusive. Liver biopsy remains the gold standard; however, it~     requires sedation in pediatric patients, has a risk of hemorrhage, and provides unreliable~     results secondary to sampling error. Sonoelastography is a new method of evaluating liver~     disease that eliminates these pitfalls. There are 3 types of quantitative sonoelastography~     currently in use.~      Transient elastography is a non-imaging based technique used in adults to measure liver~     fibrosis in which a mechanical vibrator creates a low-frequency wave causing shear stress in~     the liver at a fixed depth. This technique does not work in small livers and, therefore, is~     not appropriate for pediatric patients.~      Acoustic Radiation Force Impulse Imaging (ARFI) and Shear Wave Imaging (SWE) use real-time~     ultrasonography and administer focused high-intensity, short-duration pulses to produce~     shear waves in the liver tissue. ARFI calculates the degree of tissue displacement and~     creates an elastogram or measurement of the stiffness of the sampled liver tissue without~     corresponding images. It is limited since only a small sample or region of interest (ROI)~     can be obtained, and it is unable to provide a corresponding elasticity map of the tissue.~      SWE is the newest elastography technique. It measures tiny displacements of tissue in a~     larger ROI with corresponding ultrasound images which provides a side by side image of the~     liver and color-coded elasticity map of the sampled tissue. Advantages include a larger ROI~     and simultaneous viewing of the selected region of interest which provides better anatomic~     detail with a corresponding color map of the tissue elasticity which may result in more~     accurate scoring of the stage of fibrosis.~      There are a few studies of ARFI in the pediatric population. Studies using SWE for~     evaluation of liver fibrosis are also few, and, all but one in adults. However, these~     studies have shown it to be an accurate method for liver fibrosis staging. Use of SWE in~     assessing liver fibrosis in pediatric patients may represent an accurate noninvasive~     alternative to liver biopsy in evaluating liver fibrosis as well as avoid the use of~     sedation.~   "
52295|NCT02372669|"~     The objective of this study is to evaluate whether the additional use of a nerve tube in~     primary microsurgical repair of traumatic sensory nerve lesions of the hand has an effect on~     convalescence and functional results.~   "
52296|NCT02372656|"~     This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1%~     metformin in chronic periodontitis subjects.~   "
52297|NCT02372643|"~     Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler~     ultrasonographic parameters in a population of sexually healthy volunteer women in order to~     obtain reference values. Psychobiological correlates of female sexual function will also be~     studied through hormonal testing and psychological evaluation.~   "
52298|NCT02372630|"~     This is a single center, prospective randomized double blind, parallel and placebo~     controlled study to evaluate oxidative stress and inflammation before and after treatment~     with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin~     sensitizer.~   "
52299|NCT02372617|"~     Prospective study enrolling patients with cerebral palsy and with subluxation of the hips >~     40% and acetabular dysplasia. The patients will be stratified according the degree of~     subluxation and age. The treatment protocol is composed by femur variation osteotomy and~     periacetabular osteotomy. Patients will be divided in two groups according the type of bone~     graft used at periacetabular osteotomy (autologous or ceramic).~   "
52321|NCT02372331|"~     Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative~     hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve~     the restoration of,functional capacity after surgery on evidence-based medicine. The~     benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal~     surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation)~     is still one of most complex abdominal surgery, and there is no evidence that ERAS is~     beneficial on PD.~      This study investigate the clinical effectiveness of ERAS on PD.~   "
52833|NCT02365597|"~     The purpose of this study is to evaluate the objective response rate (complete response~     [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or~     surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.~   "
52300|NCT02372604|"~     Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily~     urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of~     the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in~     particular sleep, and generates numerous consultations and hospitalizations, with an average~     annual cost per patient close to 2000 euros in Europe. The treatment is based on the~     validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose~     effectiveness is satisfactory, however about half the time. In cases of severe CSU~     refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist,~     still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as~     immunosuppressants. Various studies have shown the important benefit of an expensive~     anti-IgE biological: the omaluzimab. Several open studies have also suggested superior~     efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple)~     including levocetirizine.~      The off-label use of these high dosages of anti-H1 is growing very rapidly in France,~     tending to replace the use of anti-H1 first generation or substitution to another 2nd~     generation anti-H1 recommended by the French Society of Dermatology.~      This study, under the aegis of the Urticaria Group of the French Society of Dermatology,~     intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the~     treatment of CSU resistant to anti-H1 licensed dosage.~   "
52301|NCT02372591|"~     Pain is very common in persons with a history of addiction, but few studies have examined~     the best treatment of pain in this population. This is a study to determine the pain relief~     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons~     maintained on stable doses of methadone or buprenorphine who have chronic musculoskeletal~     pain. Experimental sessions will require overnight stays on a residential research unit. In~     these sessions, persons will be exposed to standard experimental pain techniques at baseline~     and then rate the relief (if any) provided by the study medication when exposed to the same~     techniques. Persons will be asked to participate in 3 sessions, each separated by at least 7~     days.~   "
52302|NCT02372578|"~     The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in~     subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and~     tolerability of ASP3662 relative to placebo.~      The analgesic effect is evaluated by measuring percent responders, change in daily worst~     pain score, change in average daily pain score, Patient Global Impression of Change (PGIC)~     and Clinical Global Impression of Change (CGIC).~   "
52303|NCT02372565|"~     The purpose of this study is to evaluate the feasibility of a social media and~     text-message-delivered, Social Cognitive Theory-based, culturally relevant intervention~     designed to promote physical activity among African American women. An 8-week, 2-arm~     randomized trial will be implemented. Arm 1 will receive a culturally-relevant,~     technology-based physical activity intervention delivered via Facebook and text messages.~     Arm 2 (Comparison Group) will receive a standard print-based physical activity promotion~     materials consisting of high quality physical activity promotion brochures produced by the~     American Heart Association.~   "
52304|NCT02372552|"~     This is a single centre, prospective, non-randomised pivotal clinical investigation to be~     undertaken at St Mark's Hospital, Harrow, UK.~   "
52305|NCT02372539|"~     Dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea~     and vomiting (CINV). While effective, high dose dexamethasone is associated with numerous~     side effects, even when used for a short duration. One such effect is elevated blood~     glucose, or hyperglycemia. Current literature suggests increased risk of infection, poor~     wound healing, and increased mortality in non-cancer surgical patients with steroid-induced~     hyperglycemia. There is also evidence to support that elevations in blood glucose are~     associated with worsened outcomes in cancer patients. Much of this data comes from cancer~     patients that are treated in an inpatient setting where blood glucose is routinely checked.~     Limited data is available describing the fluctuations in blood glucose following~     dexamethasone administration in cancer patients being managed in an outpatient setting, such~     as the Anschutz Cancer Pavilion (ACP) Infusion Clinic. This study aims to characterize the~     effects dexamethasone has on blood glucose in cancer patients by utilizing Continuous~     Glucose Monitoring (CGM) devices. These devices are minimally invasive, are FDA approved,~     and can produce real-time data of blood glucose fluctuations over a course of 3-7 days. By~     inserting the devices under the skin of the abdomen, the investigators can evaluate the~     temporal relationship between glucose abnormalities and dexamethasone administration.~     Results from this study will not only increase the knowledge base of dexamethasone-induced~     hyperglycemia and identify patients at increased risk, but also allow future research to be~     conducted in order to determine if standard protocols can proactively minimize~     steroid-induced glucose fluctuations.~   "
52306|NCT02372526|"~     The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or~     protein) that most potently stimulates the endogen secretion of different gut hormones~     (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study~     also includes a comparison of the secretion of gut hormones after oral intake of lipid with~     or without a pancreatic lipase inhibitor.~   "
52322|NCT02372318|"~     The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure~     neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects~     following a single dose of the opioid receptor modulator nalmefene. The study will be done~     in a cross over design with nalmefene versus placebo.~   "
52323|NCT02372305|"~     FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue~     expanders and implants in place. There have been few chart review studies comparing outcomes~     between the two materials in breast reconstruction. These studies have determined there is~     no difference in complication rates between the two materials. However, there have never~     been any active studies to date. This study will serve as a randomized controlled trial~     comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and~     exclusion criteria to determine if either product is more suitable for use in breast~     reconstruction. This will be performed by randomly assigning patients to receive either~     FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes~     will be statistically analyzed to determine complication rates between FlexHD and Alloderm~     and thus which product is better to use in breast reconstruction.~   "
66052|NCT02192762|"~     This is a pilot study of a withdrawal regulation training program compared to relaxation~     training for individuals that are interested in smoking cessation.~   "
52307|NCT02372513|"~     Cholesteryl Ester Storage Disease (CESD) is an autosomal recessive lysosomal storage~     disorder (LSD) caused by mutations in the lysosomal acid lipase gene (LIPA) that markedly~     reduce lysosomal acid lipase (LAL) activity, leading to the accumulation of lipids,~     predominately cholesteryl esters and triglycerides, in various tissues and cell types. In~     the liver, accumulation of lipids leads to diffuse microvesicular steatosis, which~     progresses to fibrosis and ultimately, to micronodular cirrhosis. Patients typically present~     with hepatomegaly, liver dysfunction, hepatic failure and type II hyperlipidemia. Although~     hepatosteatosis is a typical finding, the liver biopsy diagnosis may be misclassified as~     non-alcoholic fatty liver disease, non-alcoholic steatohepatitis or cryptogenic liver~     disease. Biopsy and radiological findings are not considered diagnostic, but help to~     suspicion of CESD. The definitive diagnosis is based on deficient LAL activity and/or LIPA~     gene mutations.~      CESD is pan-ethnic, however, the disease incidence is unknown. The estimated incidence of~     the disease indicates that CESD should be largely underdiagnosed especially in European~     patients. Elevation of serum transaminases, and hepatomegaly are early indications of liver~     impairment. Therefore, CESD should be considered as a differential diagnosis in liver~     disease of unknown origin.~      To data, there is no study which evaluated the frequency of CESD in children with~     unexplained transaminase elevation and/or organomegaly and/or chronic liver disease. The aim~     of this prospective, multicenter and cross-sectional study is to investigate frequency of~     CESD in children with unexplained transaminase elevation and/or and/or chronic liver disease~     and to identify demographic and clinical features of CESD.~   "
52308|NCT02372500|"~     It is unknown whether post operative chewing gum will reduce post operative ileus. This~     study is a randomised controlled trial that will determine whether chewing gum three times a~     day following surgery will reduce post operative ileus. Time to passage of flatus will be~     used to determine that incidence of ileus.~   "
52309|NCT02372487|"~     The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate~     therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index~     measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to~     compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will~     remain Sildenafil-naïve.~   "
52310|NCT02372474|"~     The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal~     sc (MSC) therapy in women suffering from POF.~   "
52311|NCT02372461|"~     The relative benefits and risks of antibiotic therapy in WHO defined fast breathing~     pneumonia in pre-school children in resource limited settings are controversial both at an~     individual and public health level. Most infections are viral or self-limiting and~     non-selective drug treatment has contributed to the global epidemic of antibiotic~     resistance. There is no high quality trial evidence in managing children with fast breathing~     in community settings and the WHO itself has called for evidence on which to update~     guidance. The investigators proposed non inferiority trial comparing standard antibiotic~     treatment with placebo in poor urban slum settings in South Asia to address this deficit.~   "
52312|NCT02372448|"~     Patients eligibility to targeted therapies relies on a molecular test performed on a tumor~     sample collected by biopsy. This invasive procedure is associated with a relative high risk~     of morbidity and requires the intervention of a costly and important technical platform.~     Thus, inoperable patients can be deprived from potentially more efficient therapies. A~     liquid biopsy of Circulating Tumor Cells (CTCs) present in the blood and their molecular~     characterization is an appealing alternative to meet an urgent need for these patients.~     Moreover no CTC-based molecular test is currently routinely available.~      The 5-year survival rate of patients with non-small cell lung carcinoma (NSCLC) is low.~     Recent reports demonstrated that the detection of an ALK rearrangement in the tumor tissue~     allows patients with late-stages NSCLC to benefit from crizotinib treatment.~      However, 1) the detection of an ALK rearrangement is currently performed on small biopsies~     or fine-needle aspirates and can be hindered by the limited tissue quantities available.~     Tumor tissue is difficult to obtain in patients with advanced/metastatic lung cancer for~     whom surgery is rarely a component of treatment. Finding alternative and more effective~     means of diagnosing an ALK rearrangement are critical issues for identifying patients who~     may benefit from treatment with crizotinib; 2) some patients develop resistance to~     crizotinib due to de novo ALK mutations.~      In this setting, circulating tumor cells (CTCs), which have been shown to be detectable by~     ISET (Isolation by Size of Epithelial Tumor Cells) method in 80% to 100 % of late stages~     lung cancer patients represent a non-invasive and easily accessible source of tumor material~     for assessing ALK rearrangement and escaping mutations in a kinetic manner. The ISET method~     was first published in 2000 and several independent teams have now established its high~     sensitivity and specificity of ISET for NSCLC. With ISET, specificity can be achieved using~     the same methods and criteria used by cytopathologists to diagnose solid tumors.~      The high sensitivity and specificity of ISET are two essential starting points for the~     feasibility of this present project. Low-throughput molecular characterization of CTCs~     isolated by ISET has also been achieved. The remaining challenge consists in developing~     high-throughput ISET-based molecular tests for personalized medicine that are transferable~     to the clinics.~      The Team 1 at the CHU de Nice and the Team 2 at the Gustave Roussy Institute have~     demonstrated that the detection of an ALK rearrangement in CTC isolated by ISET is feasible~     and consistent with results obtained in corresponding tumor tissues. In this context, the~     aim of this project is to obtain 1) a definitive prospective clinical validation of the use~     of CTC as an alternative to tumor tissue for ALK analysis-based patients stratification; 2)~     a proof that escaping mutations can be detected early by kinetic analysis of CTC in patients~     treated by crizotinib. ALK rearrangement will be prospectively investigated in CTCs isolated~     by ISET at diagnosis and during follow up from patients with stage IIIb/IV lung cancer and~     de novo mutations will be searched in patients with resistance to crizotinib. This study~     will provide both clinical and economic benefit to targeted treatment of patients with~     advanced lung cancer.~      This project is strongly original as no CTC-based ALK rearrangement test has been~     independently validated up to now with clinical samples. The development of non-invasive~     theranostic test through the genetic analysis of CTCs is a clinically relevant goal for~     non-invasive stratification of cancer patients, avoiding morbidity related to lung biopsy~     and surgery. It would allow determining patient's eligibility to targeted therapies on a~     blood sample analysis. CTC-based ALK test could be useful to guide the choice of ALK~     targeted therapy in patients with lung cancer. Furthermore, developing biomarkers based on~     CTCs analysis would open the way to the non-invasive follow up of aggressive cancers, early~     detection of mutations associated with resistance to targeted therapies and tailoring~     treatment to a real time analysis of the evolving tumor cell populations. This test is~     expected to markedly improve patients' quality of life avoiding invasive diagnostic~     procedures.~   "
52313|NCT02372435|"~     Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange~     Revision.~      Patients will be randomized into 2 groups: the experimental Group will get a reimplantation~     after a short interval (2-3 weeks) while the control Group after a long standard interval.~      Primary objective of the study is Infection outcome. The infection-free status is defined~     as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and~     radiological signs of infection (e.g. no septic loosening).~      Secondary objective is Functional outcome.The functional assessment will be performed~     using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE,~     OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM),~     patient mobility / independency in daily life, subjective evaluation of pain using a visual~     analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).~   "
52314|NCT02372422|"~     The purpose of this study is to determine if the use of routine transvaginal cervical length~     ultrasound can be used to prevent preterm deliveries in twin gestations.~   "
52315|NCT02372409|"~     By employing a combination of advanced MRI techniques and correlative serum biomarkers of~     blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of~     its kind clinical algorithm in pediatrics whereby the investigators can measure and identify~     the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in~     incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the~     greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor~     progression from long-term MLA treatment effects. Preliminary data in adult imaging studies~     have shown that the BBB disruption lasts for several weeks following treatment before~     returning to a low baseline. This pilot therapeutic study will provide preliminary~     validation in pediatric patients.~   "
52316|NCT02372396|"~     The goal of this project is to refine an existing compassion meditation protocol for~     individuals with PTSD, to examine the safety and feasibility of this approach and to collect~     data to make initial estimates of efficacy.~   "
52317|NCT02372383|"~     The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and~     pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of~     nontuberculous mycobacterial (NTM) lung disease.~   "
52318|NCT02372370|"~     The study investigates the potential of a range of different physical pretreatments to~     enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to~     photodynamic therapy (PDT).~   "
52319|NCT02372357|"~     A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated~     pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.~   "
52320|NCT02372344|"~     The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of~     AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male~     Japanese subjects.~   "
52422|NCT02371070|"~     The investigators study aims to test the correlation between the Hemochron Signature~     point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently~     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to~     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in~     real-life stroke patients.~   "
52324|NCT02372292|"~     Although the traditional determinant of renal dysfunction in heart failure was suggested as~     decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the~     association of persistent systemic venous congestion and kidney dysfunction. Relief of the~     congestion has demonstrated to improve renal functions in decompensated heart failure. The~     current trial was set up to investigate the changes of renal venous impedance and renal~     arteriolar resistivity indices with diuretic therapy, in patients with congestive renal~     failure. The investigators asked whether measurement of renal venous impedance index or~     renal arteriolar resistivity index can guide the practice of diuretic therapy.~   "
52325|NCT02372279|"~     In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of~     embryos outside the incubator to assess their morphology and establish a selection process~     is performed. In this way it is possible to know which embryo or embryos have greater~     implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy.~     However, these observations can produce deleterious effects on embryo development due to~     changes in temperature, pH and osmolarity of the culture media, as well as a negative effect~     of direct light microscope for observation. This project aims to test the hypothesis that~     non-embryonic observation produces a beneficial effect on embryo quality until day 5 of~     development (blastocyst stage) and, therefore, on rates of implantation and ongoing~     gestation, compared with the conventional protocol of observations under the inverted~     microscope on days two, three and five of development.~   "
52326|NCT02372266|"~     To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours)~     with a home visit on admission to the Level II/III nursery and hospital admissions and~     readmissions.~   "
52327|NCT02372253|"~     The overall purpose of this trial is to assess the efficacy and safety of using oral~     verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the~     patients' endogenous beta cell mass and insulin production. The objectives are therefore to~     assess parameters of beta cell survival (including new biomarkers), insulin production and~     glucose control and the feasibility of this approach and thereby provide the basis for~     future, larger/expanded, longer-term verapamil studies and the off-label use of this~     approved drug for T1D.~   "
52328|NCT02372240|"~     This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV~     infusion administered with low dose dexamethasone in patients with relapsed or relapsed and~     refractory multiple myeloma.~   "
52329|NCT02372227|"~     The purpose of this study is to evaluate rising dose levels of VS-5584 administered in~     combination with a fixed dose of VS-6063 in subjects with relapsed malignant mesothelioma to~     determine a recommended Phase 2 dose (RP2D) for further development of this combination in~     this indication.~   "
52330|NCT02372214|"~     The purpose of this study is to produce a patient-specific simulator for endovascular~     infra-renal aneurysm repair training and than analyze the effect of simulator training on~     the performance of vascular surgery residents.~   "
52331|NCT02372201|"~     Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI~     microbiota and well being are analysed in subjects claiming GI inconveniences due to~     Irritable Bowel Syndrome or food intolerances.~   "
52332|NCT02372188|"~     The purpose of this study is to elucidate whether bitter taste induced by the bitter~     compound caffeine and the reduction of bitter taste by addition of the bitter masking~     compound Homoeriodictyol sodium salt (HED) influence gastric acid secretion, subjective~     feelings of hunger, ad libitum food intake and satiating hormones in healthy volunteers.~   "
52333|NCT02372175|"~     To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to~     develop an appropriate challenge model. To this end, this first-in-human study will examine~     the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)~     product and assess the ability of this virus strain to elicit an uncomplicated dengue-like~     illness.~   "
52334|NCT02372162|"~     This single center, open-label, uncontrolled, non-randomized observational study in patients~     with advanced HCC. The patients qualify either to a local treatment with transarterial~     chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor~     sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular~     fingerprint of individual tumors, with the intention to govern therapy decisions.~     Furthermore, to improve the care of patients that get progressive disease under treatment,~     the investigators have to improve the investigators understanding of the development of~     therapy resistance, which will improve patient care at the time point of progressive~     disease. Therefore, the data of 20 patients in each group will be used to identify molecular~     and / or image patterns, that can be used to predict treatment responses and thus govern an~     optimized individual cancer treatment for patients with advanced HCC.~   "
52335|NCT02372149|"~     The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an~     effective intervention for patients with diabetes, peripheral neuropathy, and demyelination~     on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months~     each, with a 3 month washout period in between.~   "
52336|NCT02372136|"~     In preterm infants fed human milk, milk needs to be fortified to meet nutrient~     recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on~     daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on~     growth rate and serum analyses).~      The first specific aim will determine whether individualized and optimized nutrition during~     hospitalization results in improved growth in the neonatal intensive care unit (NICU) in~     extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA,~     birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.~      The second specific aim will determine whether individualized and optimized nutrition in the~     NICU improves neurodevelopmental outcomes (acquisition of development milestones) and~     reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings~     suggestive of metabolic syndrome in the first 3 years of life.~   "
52337|NCT02372123|"~     The aim of this study is to investigate the effect of connective tissue manipulation on pain~     threshold in women with primary dysmenorrhoea. According to literature, there are studies~     that measure the pain threshold. But there is no randomized controlled trial which explore~     the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea.~     Hypothesis of this study is that connective tissue manipulation increases pain threshold and~     decreases severity of pain in women suffer with primary dysmenorrhoea.~   "
52338|NCT02372110|"~     The proposed study aims to investigate experimentally anxiety sensitivity and physiologic~     sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and~     a set of social stress challenges. Following informed consent, participants will be~     instructed to ingest either 400 milligrams of caffeine (an amount of caffeine roughly~     equivalent to that in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of~     hydrocortisone or two placebo capsules via stratified, random assignment. Physiologic and~     self-reported measures of stress and anxiety will be taken.~   "
52339|NCT02372097|"~     The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25~     milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.~   "
52340|NCT02372084|"~     To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in~     subjects with mild, moderate and severe hepatic impairment compared with subjects with~     normal hepatic function.~   "
52341|NCT02372071|"~     The primary objective of this study is to define the performance evaluation of BiliCare TcB~     device to the gold standard bilirubin tests.~   "
52342|NCT02372058|"~     The primary objective of this study is to define the performance evaluation of BiliCare TcB~     device to the gold standard bilirubin tests.~   "
52343|NCT02372032|"~     Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery.~     Open discectomy used to be a widespread procedure for surgical treatment for symptomatic~     LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous~     lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and~     ozone therapy combined other minimally invasive treatment could improve other minimally~     invasive treatment's clinical effectiveness. The effectiveness of which has been proved to~     be comparable to conventional open discectomy.~      In this study, a single-blind randomized controlled trial will be performed to evaluate the~     effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined~     with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.~      Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc~     herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc~     herniation undergoing PLD.~      The primary endpoints of the study will be changes in in pain and functional status by the~     Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability~     Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as~     measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include~     response evaluation by MacNab response evaluation criteria as measured at pre- and~     post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference~     in the mean change from baseline between the two groups.~      For the first time,the results of this trial will provide scientific evidence as to the~     relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical~     treatment for symptomatic lumbar disc herniation.~   "
52344|NCT02372019|"~     The purpose of this study is to determine whether briefly reactivating a fear memory 20~     minutes prior to administering a social anxiety treatment will enhance the durability of~     treatment effects.~   "
52345|NCT02372006|"~     Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion~     cohort~      The trial will consist of 2 parts:~        1. Dose finding part to determine the MTD~        2. Biomarker specific MTD expansion cohort to assess clinical anti-tumour activity in~          included tumour types~   "
52346|NCT02371993|"~     Asthma in the elderly is poorly understood, as most studies have not included this patient~     group. In a previous study of adults with asthma, choline supplementation had a positive~     effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The~     present study is a randomized, double-blind, placebo-controlled, cross-over study of choline~     supplementation. The investigators will study the effect of choline 650 mg taken orally~     twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and~     spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the~     effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E~     (IgE) and homocysteine levels.~   "
52347|NCT02371980|"~     The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg)~     versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the~     prevention of relapse in participants with major depressive disorder (MDD) who responded to~     acute treatment with vortioxetine 10 mg.~   "
52348|NCT02371967|"~     Previous clinical trials have demonstrated the efficacy of Erivedge® in patients with~     advanced Basal Cell Carcinoma (BCC) and Gorlin syndrome. This prospective, observational,~     cohort study is designed to assess the effectiveness and safety outcomes of Erivedge® and to~     assess actual day-to-day disease and patient management by the physician.~   "
52349|NCT02371954|"~     The study is a randomized pilot trial of a health promotion intervention in the prevention~     of anxiety and depression in older Hispanics.~   "
52350|NCT02371941|"~     This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when~     made into a viscous preparation for the treatment of eosinophilic esophagitis.~   "
52351|NCT02371928|"~     This study is designed to investigate the efficacy and safety of a supervised neuromuscular~     exercise program versus a standard home exercise program for patients with post-traumatic~     symptomatic anterior shoulder instability.~      Participants with at least one week of symptom duration are randomly assigned to either a~     12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program~     versus a standard HOMe EXercise (HOMEX) program.~      The H1-hypothesis is that the SINEX program results in a greater increase in quality of life~     and physical function than the HOMEX program at the primary endpoint at three months~     follow-up from baseline~   "
52352|NCT02371915|"~     This project will be conducted in two phases. Phase 1: RA patients will be recruited to~     participate in five repeated examinations occurring in one day to compare between and within~     specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients~     living > 100 km from Saskatoon will be randomized to the intervention or control group, with~     both groups having three follow-up appointments in 3-month intervals. The intervention group~     will be evaluated by a physiotherapist supported by a rheumatologist through~     videoconferencing, while the control group will continue to travel to Saskatoon for~     follow-up care.~   "
52353|NCT02371902|"~     Chronic lateral epicondylitis is usually managed conservatively. The purpose of this~     single-blinded, randomized, controlled study is to compare the clinical therapeutic effects~     of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US)~     therapy in chronic lateral epicondylitis (LE) during a period of 12 months.~   "
52511|NCT02369835|"~     This randomized phase III trial studies how well modified Dakin's solution works in reducing~     radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with~     head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce~     inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.~   "
52354|NCT02371889|"~     The purpose of this study is to advance the effort to develop personalized pharmacotherapy~     for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week,~     prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy~     of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5~     AUD. The investigators will stratify the randomization on genotype and oversample~     rs2832407*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of~     patients in the four medication x genotype groups. The investigators will use daily data~     collection to examine changes in relevant process variables (e.g., alcohol expectancies) and~     their interaction with genotype and medication group as predictors of HD. The proposed study~     is innovative in that it will be the first prospective test of a pharmacogenetic hypothesis~     involving TOP; it will use daily reports to examine expectancies and how they interact with~     medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is~     either to reduce or stop drinking, which will increase the study's external validity.~   "
52355|NCT02371876|"~     The purpose of this study was to determine if untrained subjects with diabetes can operate~     the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid~     glucose results.~   "
52356|NCT02371863|"~     Surgical treatment is the only approach with potentially defined clinical success for~     organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial~     successful MV repair is a clinical challenge in current practice. Especially when echo~     parameters at rest are within or near normal ranges and patients presenting~     disproportionately symptomatic in relation to the observed results. However, while MV~     regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic~     echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress~     echocardiography is a promising technique to complement nowadays rest TTE in order to~     improve interpretation of hemodynamic changes. However, normal values for exercise echo are~     lacking in this postoperative patients cohort. A prospective, observational trial to~     determine normal values in stress echocardiographic parameters in asymptomatic patients~     after successful MV repair for organic MV regurgitation, is therefore highly needed.~      Purpose of the SEP- study is to determine normal values in stress echocardiographic~     parameters in asymptomatic patients at least 6 months after successful MV repair for organic~     MV regurgitation. These normal values for stress echo are of utmost importance to correctly~     and accurate interpret stress echo results during postoperative follow-up and to improve~     clinical decision making in patients post MV repair.~   "
52357|NCT02371850|"~     This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to~     compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin~     patch) nicotine skin patches in adult smokers.~   "
52358|NCT02371837|"~     The intervention will consist in a 6 week of pilates practice in older population to check~     the prevention of fall effectiveness.~   "
52359|NCT02371824|"~     DCE-MRI were performed in sixty adults (hips and lumbar spine). For each region of interest~     studied, the investigators determined the morphology of each time-concentration curve (TCC)~     and calculated semi-quantitative and pharmacokinetic parameters: initial slope (IS), area~     under the curve (AUC), time to peak (TTP), Ktrans, Kep and Ve. Clinical data were collected~     anamnestically.~   "
52360|NCT02371811|"~     The investigators use v care during abdominal hysterectomy and evaluate its effect on~     duration of operation time, surgical complications and vaginal length.~   "
52361|NCT02371798|"~     The purpose of this research study is to see if magnetic resonance imaging (MRI) with a~     double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere~     Disease.~   "
52362|NCT02371785|"~     This study evaluates the performance of the CorPath 200 System to deliver guide wires and~     balloons to blockages in the arteries of the leg.~   "
52363|NCT02371772|"~     The aim of the study was to compare self-management of anticoagulant treatment with~     conventional anticoagulant treatment in Norway.~   "
52364|NCT02371759|"~     The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15~     mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral~     local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe~     (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate)~     intraoral local anesthesia in patients with Diabetes mellitus type 2.~   "
52365|NCT02371746|"~     This is a multiple cohort study that will evaluate the safety and efficacy of ENV515~     travoprost XR in patients with open-angle glaucoma or ocular hypertension.~   "
52366|NCT02371733|"~     Decreased exercise capacity, peripheral muscle strength and quality of life and increased~     dyspnea and fatigue perception is prevalent in patients with pulmonary arterial~     hypertension. It was demonstrated exercise training has beneficial effects in patients with~     pulmonary arterial hypertension. However, no study investigated the effects of upper~     extremity aerobic exercise training, therefore effects of upper extremity aerobic exercise~     training on outcomes in patients with pulmonary arterial hypertension.~   "
52367|NCT02371720|"~     The purpose of this research study is to learn about ways to help children and adults with~     sickle cell disease who are taking the medication, hydroxyurea.~   "
52368|NCT02371707|"~     This study aims to establish bioequivalence between two tablet formulations of idalopirdine~   "
52374|NCT02371629|"~     This study is a post-authorization commitment to the European Medicines Agency (EMA). The~     study serves to determine whether the treatment of patients with stable, symptomatic Chronic~     Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and~     safe. The efficacy and safety of the drug will be tested for twice daily dosing against once~     daily dosing. The primary criterion to assess efficacy will be the trough FEV1 (defined as~     mean evaluation at 23 h 15 min and 23 h 45 min post dose) measurements of patients who have~     been treated for 12 weeks with NVA237 b.i.d versus those that have received NVA237 o.d.for~     12 weeks.~   "
52375|NCT02371616|"~     An 8 week clinical study to evaluate the ability of an experimental dentifrice containing~     calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine~     hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate~     and sodium monofluorophosphate.~   "
53716|NCT02354027|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.~   "
52369|NCT02371694|"~     Background: Based on international evidence, current management of people with T1DM on~     intensive insulin therapy (IIT) use algorithms based on the meal carbohydrate content (MCC)~     to calculate the prandial insulin dose. Typically, these calculations do not take into~     account the protein or fat content of the meal. There is a lack of clinical advice for~     optimal management of high protein/fat meals due to a paucity of evidence regarding the~     impact of protein/fat on glycaemic control.~      Objective: To determine the mean glucose excursion from fasting (measured by continuous~     glucose monitoring, CGMS) at each 30 minute interval over the 8 hour postprandial period for~     each test condition. Protein effects will be looked at in a separate parallel study in~     Australia.~      Hypothesis: The fat content of a meal will cause a dose-response change in the postprandial~     glucose concentration in children with T1DM.~      Research Design and Methods: Randomised cross-over study involving thirty patients.~     Inclusion criteria: T1DM >1 year, aged 8-18 years, with HbA1c <8% and BMI <91st centile, on~     intensive insulin therapy. Participants will be given a test meal on 6 consecutive nights in~     random order; 4 test meals varying in fat content, and one 20g carbohydrate test meal with~     zero fat given as control meal. A CGMS will be used to assess glucose responses at 5 minute~     intervals for 8 hours after test meal consumption. The relationship between the fat loads in~     the test meals and the mean change in postprandial glucose concentration will be analysed~     and described.~      Conclusions: This study will determine whether fat causes dose dependent response in glucose~     concentrations leading to refining the guidelines and possible adjustment of insulin doses~     for the fat content of a meal.~   "
52370|NCT02371681|"~     Background:~      - Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they~     may spread these bacteria. Researchers are looking for new TB medicines. They want to find a~     faster way to tell if a drug might combat TB.~      Objective:~      - To learn the effect of different anti-TB drugs on microbiological, radiographic and~     immunologic markers in people with TB.~      Eligibility:~      - Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with~     common TB medicines.~      Design:~        -  Participants will be admitted to the hospital for screening. They will have medical~          history, physical exam, and chest radiograph. They will give blood, urine, and sputum~          samples.~        -  Participants will be put in 1 of 8 groups.~        -  Participants will get one or a combination of TB medicines daily for about 14 days.~        -  Each day, participants:~        -  Will discuss side effects.~        -  May have a physical exam.~        -  Will spit mucus into a cup. They may breathe in saline water through a nebulizer to~          make them cough.~        -  Participants will have blood taken 3-4 times during the study~        -  Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed~          Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure~          TB disease in the lungs. It will be injected into a vein. Participants will lie in a~          scanner that takes pictures.~        -  Around study day 14, participants will leave the hospital. They will be referred to a~          local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will~          already be on these medicines and will have another FDG-PET/CT on day 28.~        -  Participants will be in the study for up to 28 days.~   "
52371|NCT02371668|"~     Background:~      - Researchers want to see if a new drug reduces flu disease in people treated with this drug~     versus a placebo. The drug has an antibody that may help the immune system fight the flu.~     Placebo is only sugar and water. All participants will get the flu virus. They may or may~     not develop flu symptoms.~      Objective:~      - To see if the drug CR6261 reduces flu disease in people treated with this drug versus a~     placebo.~      Eligibility:~      - Healthy nonsmokers ages 18 45.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants must use contraception or abstinence for several weeks before and after~          the study. They must have no alcohol for 1 day before each visit. Any medicine must be~          approved by the study doctor until after follow-up.~        -  Participants will stay in a hospital isolation unit for at least 10 days.~        -  They will have:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart and lung test~        -  Tests for drugs and alcohol~        -  Throughout their stay, participants will:~        -  Be closely watched by a medical team~        -  Have nasal washes and swabs several times a day~        -  Participants will have the flu virus sprayed in each nostril.~        -  The next day, participants will get either study drug or placebo through a soft plastic~          tube placed in a vein by needle. It will take 2 hours. They will not know which they~          get.~        -  Participants can go home after 10 days if they test negative for the flu 2 days in a~          row.~        -  Participants will have daily questionnaires at home and 2 follow-up visits over 2~          months.~   "
52372|NCT02371655|"~     The aim of this study is to compare a new regimen of reduced bowel preparation that does not~     include low fiber diet with another reduced bowel preparation including low-fiber diet.~   "
52373|NCT02371642|"~     The purpose of this project is to evaluate the utility of left ventricular strain as part of~     the assessment of patients in the emergency department with acute heart failure (HF). The~     central hypothesis of the investigation is that left ventricular strain will prove to be a~     treatment response variable in patients with acute HF. Patients who are being treated for~     acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes)~     will be eligible for enrollment. Patients who give written consent will receive a focused~     bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images~     that are captured during this echocardiogram will be interpreted by a blinded cardiologist~     offline. 23 hours after this initial focused echocardiogram a member of the study team will~     perform a follow-up focused echocardiogram, capturing the same images that will then be~     interpreted by a blinded cardiologist offline.~      Offline analysis will be performed using a proprietary software package from General~     Electric called Automated Function Imaging (AFI). The AFI software will be used to calculate~     longitudinal strain of the left ventricle (LV). Regional and global strain values will be~     calculated for each focused echocardiogram for each subject. It is our hypothesis that LV~     strain will demonstrate improvements from the initial echocardiogram to the follow-up~     echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.~   "
52405|NCT02371226|"~     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This study is a~     safety and dose ranging study to obtain safety and exposure data, as well as information on~     the biological activity of the investigational drug.~   "
52376|NCT02371603|"~     This study will be a two-part with an open-label, single oral dose, two-way crossover study~     design. Part A and Part B of the study are independent and may be conducted in parallel. The~     Part A of the study will assess the effect of an oral dose of GSK1278863 on the~     pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in~     order to determine the potential for clinically-significant drug interactions with CYP2C8~     and OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8~     inhibitor (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant~     metabolites. Part A will be conducted in approximately 30 healthy subjects, having a~     randomized study design. There will be approximate 7-day washout period between each dosing~     period. Part B will be conducted in approximately 20 healthy subjects, having single~     sequence study design. Follow up will be conducted within 7 to 10 days after the last dose~     in both Part A and B. The total duration of a subject's involvement in the part A of the~     study will be approximately 8 weeks (Screening to Follow-up) and in part B will be~     approximately 7 weeks (Screening to Follow-up).~   "
52377|NCT02371590|"~     This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated.~     This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this~     setting and induce complete clinical responses.~   "
52378|NCT02371577|"~     This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential~     beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL)~     and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small~     lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune~     compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease).~   "
52379|NCT02371564|"~     Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor~     outcome, especially when intubation is required, thus underlining the importance of~     optimizing non-invasive ventilatory support to avoid intubation. Practically, because of~     treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day~     for a long period of time and alternative solutions must be found to deliver oxygen as~     efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy~     (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2~     21-100%) through a dedicated nasal cannula and can be interesting in this context. This well~     tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in~     patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using~     HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can~     conceptually be interesting. First, the high air-oxygen flow delivered well matches the~     patient's inspiratory demand and should decrease the work of breathing. Second, as during~     HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead~     space should occur and CO2 clearance should be enhanced. Despite this strong physiological~     rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of~     using HFHO instead of conventional oxygenotherapy in combination with non-invasive~     ventilation (NIV) in this context has never been explored.~      The main objective of the study is to explore the effects of using HFHO in combination with~     NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.~   "
52380|NCT02371551|"~     The primary concern in complex renal cysts (CRC) with malignant potential is the accurate~     diagnosis and characterization. Patients with CRC have to undergo frequent imaging~     surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The~     gold standard for establishing diagnosis and necessity for surgical intervention (i.e.~     partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is~     the radiation dose to the body and intravenous contrast media administration, which has a~     risk of nephrotoxicity.~      Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and~     contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion~     characteristics without ionizing radiation or nephrotoxic contrast media. To compare the~     diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold~     standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main~     hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and~     classification of CRC lesions.~   "
52381|NCT02371538|"~     Human Breast milk in young children with Norovirus Infection~   "
52382|NCT02371525|"~     To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention~     for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men~     (MSM).~   "
52383|NCT02371512|"~     Study to assess mitral valve reconstruction for advanced insufficiency of functional or~     ischemic origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily~     functional pathology and reduced left ventricular function considered to be at high surgical~     risk~   "
52384|NCT02371499|"~     The aim of the study is to collect data for the assessment of the Lactobacillus casei DG~     (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut~     microbiota composition in patients with Irritable Bowel Syndrome.~   "
52385|NCT02371486|"~     Cesarean scar defects (CSDs), i.e. deficient uterine scars following a cesarean section,~     involve discontinuity at the site of a previous Cesarean section scar. These anatomical~     defects have been reported to be associated with postmenstrual spotting, chronic pelvic pain~     and infertility. Few case series have suggested improved fertility (most probably by~     improving implantation of embryos) The aim of this study is to prospectively record~     embryonal implantation rate during IVF in patients with CSDs, and to evaluate the effect of~     hysteroscopic repair of CSDs on fetal implantation during IVF.~   "
52386|NCT02371473|"~     Acetazolamide improves central sleep apnea related to opium consumption.~   "
52387|NCT02371460|"~     The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or~     DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their~     infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36~     weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid~     (DHA), an omega-3 lipid, while the other half will receive a placebo.~   "
52406|NCT02371213|"~     The purpose of the study is to determine whether social networking on mobile phone in~     antenatal care health education is effective in the improvement of maternal and neonatal~     outcomes compared with usual antenatal care.~   "
52388|NCT02371447|"~     This phase I/II trial will assess the safety and efficacy of intravesical instillation of~     VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB~     (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the~     trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II~     dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D~     to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of~     VPM1002BC will be compared to results previously reported for BCG in a similar population.~     The quality of life will be also investigated as a secondary endpoint. Additional immunology~     assessments are foreseen as exploratory analyses to investigate the immunogenicity of~     VPM1002BC.~      The Phase II of the trial has been opened on 27.07.2016.~   "
52389|NCT02371434|"~     The aim of this trial is to collect evidence of the safety of administering autologous~     CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant~     recipients. In addition, the study will determine whether post-transplant nTregs infusion~     allows a tapering of conventional maintenance immunosuppression within 60 weeks after~     transplantation.~   "
52390|NCT02371421|"~     To pursue this objective, we will be measuring uric acid at baseline and post 14 days of~     twice daily allopurinol therapy in 30 Hmong participants with documented gout or~     hyperuricemia and known genotype for key renal transporters of uric acid.~   "
52391|NCT02371408|"~     The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in~     combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4~     patient populations:~        1. Treatment-naïve patients, with and without cirrhosis (Group 1)~        2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)~        3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)~   "
52392|NCT02371395|"~     Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity~     surpassing 250 million cases, with approximately 800,000 deaths, per year. Of the four~     species of malaria parasites that cause human infection, P. falciparum is responsible for~     the majority of severe malaria cases followed by P. vivax. Early and accurate diagnosis is~     essential for prompt and correct treatment, which can reduce the death rate and interrupt~     transmission. Currently, conventional methods for the diagnosis of malaria include~     microscopic examination of thin and thick blood smears and rapid diagnostic tests (RDTs).~     Light microscopy in practice typically detects parasitemia as low as 100 parasites/µl and it~     can differentiate species. The advantage of microscopy includes the ability to estimate~     parasitemia, the possibility to identify parasite stages, including gametocytes, and its low~     cost. However, this method is labor intensive, difficult to standardize, and requires~     well-trained microscopists. The majority of RDTs are based on detection of P. falciparum~     histidine-rich protein 2 (HRP-2) antigen and do not detect all malaria species. RDTs that~     detect lactose dehydrogenase (LDH) and aldolase generally broadly react with all four~     species of malaria parasites and therefore cannot differentiate among the species although~     efforts are underway to improve their performance for species detection. In settings where~     multiple malaria species co-circulate, molecular methods may be more reliable than~     microscopy and RDTs in accurately diagnosing the species of malaria parasites with low~     parasitemias. However, conventional molecular methods, such as nested polymerase chain~     reaction (nested PCR) or real-time PCR, are technically challenging and resource intensive~     and are generally restricted to reference laboratories due to the need for well-equipped~     laboratories. Recently, new molecular methods that can be used in field settings have been~     developed and this opens up new opportunities for exploring molecular tools for malaria~     diagnosis in endemic countries. With the objective of facilitating use of molecular tools~     for malaria control programs, the malaria laboratory at the Centers for Disease Control and~     Prevention (CDC) in Atlanta, USA developed a simple isothermal molecular method called~     Real-Time Fluorescence Loop-Mediated Isothermal Amplification (RealAmp) for the diagnosis of~     malaria. Currently, RealAmp primers exist for detecting the Plasmodium genus and the~     detection of P. falciparum and P. vivax species. The RealAmp method has great potential as a~     molecular tool for the diagnosis of malaria in the field (and other infections of major~     public health impact, such as HIV and tuberculosis). It can provide an alternative to~     conventional PCR-based diagnostic methods for field use in clinical and operational~     programs. The objective of this proposal is to validate the sensitivity of RealAmp for~     detection of malaria parasites in blood spots from patients with clinical diagnosis of~     malaria in two endemic states of Brazil with co-circulation of P. falciparum and P. vivax.~     In this evaluation, RealAmp and microscopic examination will be compared to a real-time PCR~     method as a reference test.~   "
52393|NCT02371382|"~     The purpose of this multicentre, prospective study is:~        -  Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3~          years, 5 years, 7 and 10 years.~        -  Report Safety and Survivorship up to 10 years F/up.~   "
52394|NCT02371369|"~     This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an~     investigational drug PLX3397 in the treatment of tumour of pigmented villonodular synovitis~     or giant cell tumor of the tendon sheath in subjects, for whom surgical removal of the~     tumour would cause more harm than good. The main purpose of this study is to gather~     information about the investigational drug PLX3397, which may help to treat these tumours.~      The study consists of two parts. In Part 1, eligible study participants will be assigned to~     receive either PLX3397 or matching placebo for 24 weeks. A number of assessments will be~     carried out during the course of the study, including physical examinations, blood tests,~     imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate~     the response of the tumour to the treatment which will be independently assessed by central~     readers blinded to the treatment assignment. Those subjects, whether assigned to PLX3397 or~     matching placebo, who have completed Part 1 (i.e, complete 24 weeks of dosing and the Week~     25 assessments) will be eligible to advance to Part 2, a long-term treatment phase in which~     all subjects will receive open-label PLX3397~   "
52395|NCT02371356|"~     Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal~     outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant~     confusion exists about if and how depression during pregnancy should be treated, given the~     unknown risk-benefit profiles of various treatments. We propose to conduct a two-stage~     prospective cohort study to determine if treating depression in pregnancy is effective in~     improving fetal outcomes, and which treatment is most effective: pharmacotherapy,~     psychotherapy or a combination. The risk-benefit of the treatments will be examined~     separately for two depression types: pregnant women with depression only and those with~     other psychiatric comorbidities to evaluate possible differences in treatment effectiveness~     between the two groups. Findings will provide answers to long standing stakeholder questions~     of how to treat depression in pregnancy and which treatment is most effective with the best~     risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could~     reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.~   "
52396|NCT02371343|"~     Gestational diabetes is the development of diabetes during pregnancy. Left untreated,~     gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications~     for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect~     women from two serious pregnancy complications -- gestational diabetes and preeclampsia.~     Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give~     her developing baby every advantage in life starting in-utero. Recent studies suggested that~     the biologic processes underlying the observed associations may involve epigenetic changes,~     specifically DNA methylation. In this study the investigators aimed to examine the effect of~     fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and~     insulin like growth factor 1 DNA methylation.~   "
52397|NCT02371330|"~     This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100~     (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding~     Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth~     weight <1500 grams and with different degrees of thrombocytopenia.~      The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary~     hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count~     alone. A bleeding risk assessment marker could help physicians more accurately determine the~     risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in~     neonates with thrombocytopenia.~   "
52398|NCT02371317|"~     The purpose of this research study is to examine the efficacy of two stress management~     interventions in reducing blood pressure (BP) in patients who have prehypertension (BP~     between 120/80 and 139/89). It is expected that participants will be better able to control~     their BP through reducing stress and increasing healthy lifestyle behaviors.~   "
52407|NCT02371200|"~     Prospective study of an electromyography (EMG) based seizure detection and warning system~     for detecting generalized tonic-clonic (GTC) seizures.~   "
52512|NCT02369822|"~     There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The~     investigators propose that vitamin C being an antioxidant will improve seizure frequency and~     EEG in children with idiopathic intractable epilepsy.~   "
52399|NCT02371304|"~     Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME).~     Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days~     mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch~     Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated~     with substantial loss of health related quality of life due to defecation disorders,~     incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are~     acceptable when radical surgery is the only option for cure. Advances in technology enabled~     the development of local excision of early rectal cancer with precise endoluminal~     microsurgery or local endoscopic excision resulting in a significant decrease in short- and~     long term morbidity. However current evidence is of inadequate quality to conclude on the~     oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and~     tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment~     of the excised tumor tissue provides the optimal information on tumor stage, tumor~     characteristics and tumor differentiation, thereby it enables to predict the risk of~     recurrence after local treatment alone. For early rectal cancers, with a low risk on~     recurrence based on favourable tumor characteristics local excision is seen as safe and~     these patients do not require an additional treatment. However, for patients with early~     rectal cancer with a higher risk on recurrence based on tumor characteristics there is no~     consensus on the additional treatment after local excision. According to the National~     guideline these patients receive a TME procedure. However, for this subgroup of patients~     local treatment followed by chemoradiotherapy might also be oncological safe. Current~     evidence is of inadequate quality to be conclusive. For this subgroup of patients with early~     rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which~     patiens will be randomised after local endoluminal excision between an additional~     TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will~     be local recurrence at 3 three year follow-up.~   "
52400|NCT02371291|"~     Our collection of memories for personal experiences plays an important role in shaping our~     sense of who we are as people. These memories, termed autobiographical memories, can also be~     helpful in social situations, for sharing the details of our experiences with other people,~     reminiscing about pleasant times and solving problems by remembering what has and hasn't~     worked in the past. Different types of autobiographical memory are helpful to us depending~     on the particular situation the investigators are in at the time. Recent research has shown~     that experiencing depressed mood can affect how we relate to our autobiographical memories,~     so that instead of providing a rich source of personal information in a helpful and flexible~     way, the types of memories that come to mind are more narrowly focused on difficult or~     negative experiences. This can cause low mood to persist over time.~      The purpose of this study is to test a newly-developed therapeutic training package for~     depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to~     autobiographical memories. The MemFlex programme consists of a one-to-one orientation~     session with the researcher to introduce the training package, followed by a workbook that~     is completed at home.~   "
52401|NCT02371278|"~     The loss of muscle mass with aging is associated with a dysregulation of muscle protein~     synthesis (MPS) that is generally characterized by a suppressed MPS response to protein~     ingestion. This 'anabolic resistance' to protein feeding can be overcome with the ingestion~     of larger protein servings (~0.4g/kg/meal, equivalent to ~ 30 - 40g/meal); however, older~     adults would likely find it challenging to consume such quantities of protein on a per meal~     basis.~      The amino acid leucine has a unique role as a key 'activator' of MPS. Some research shows~     that increasing the leucine content of a suboptimal dose of a protein supplement can enhance~     the MPS response in older adults. However it is currently unknown whether the co-ingestion~     of leucine with normal, mixed meals can increase MPS. Furthermore, it has been suggested~     that leucine supplementation may only benefit older adults consuming suboptimal daily~     protein intakes. Therefore, the purpose of the current study is to examine the impact of~     leucine co-ingestion with mixed macronutrient meals on the myofibrillar protein synthetic~     response in older men consuming daily protein intakes at or below the current~     recommendations. A further objective is to determine whether the myofibrillar protein~     synthetic response to a session of resistance exercise is enhanced by leucine~     supplementation with meals. The investigators hypothesize that, in both the exercised and~     non-exercised condition, leucine co-ingestion at meals will enhance integrative myofibrillar~     protein synthesis in older adults consuming lower daily protein intakes, but will not~     augment MPS in those consuming higher daily protein. The investigators further hypothesize~     that the influence of leucine supplementation on MPS will be greater in the exercise~     condition than the non-exercise condition.~   "
52402|NCT02371265|"~     The overall objective of the study is to develop and test a pilot intervention in central~     Mozambique to implement the new WHO Option B+ guidelines that seek to increase the~     proportion of HIV-positive pregnant women in six antenatal care clinics who start~     antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.~   "
52403|NCT02371252|"~     Osteoporosis is a common disease defined as a decrease in bone mass and strength which~     increases risk of fragility fractures. This disorder may affecting health in many adults~     which causing disability, morbidity, and mortality. Current first-line medical therapy is~     bisphosphonates which alendronate is one of the most widely used. However, expenditure on~     medicines is one of the major problem of inadequate access to treatment.~      The investigators hypothesized that generic alendronate will have the same clinical efficacy~     as the brand formulation. Therefore, the result of this study is extremely crucial. If~     adequate efficacy of generic alendronate could be established and if it affords the same~     safety profile as those of brand alendronate, the use of generic alendronate could then be~     recommended.~   "
52404|NCT02371239|"~     Introduction: Changes in lifestyle are responsible for an important part of the type 2~     diabetes epidemic of the last decennia. Current guidelines for physical activity focus~     mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical~     activity (most often physical exercise). Recent studies suggest that sitting has negative~     metabolic effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).~      Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to~     be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise,~     LIPA might be a more feasible strategy. But, it remains to be determined whether reducing~     sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less~     blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether~     these effects are independent of the increase in energy expenditure~      Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2)~     who perform no, or only little, exercise and who are treated with diet only or with oral~     blood glucose lowering medication. They will perform three regimes of each four days: 1) a~     sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of~     the exercise regime will be identical to that of the sit less regime. Sitting, walking and~     standing will be objectively measured by a 24 hour physical activity monitor. The energy~     spent during exercise will be standardised and quantified by using a bicycle ergometer;~     energy intake will be standardised as well. During each regime blood glucose will be~     measured with a 24 hour continuous glucose sensor.~   "
52408|NCT02371187|"~     Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse~     type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment,~     such as metformin. Recent data (animal and human) suggest that metformin may attenuate the~     favorable benefits of exercise training. In light of the physiological mechanism of~     Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that~     rather than inhibit, it will augment the favorable adaptations to exercise training.~   "
52409|NCT02371174|"~     The primary objective of the study is to clarify factors affecting the incidence of~     peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be~     enrolled in this study with 295 patients in the treatment group of primary or secondary~     chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.~   "
52410|NCT02371161|"~     A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility~     and activity of high-dose therapy with stem cell in elderly patients with aggressive~     lymphoma relapsed FIT or resistant to first line therapy.~   "
52411|NCT02371148|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory~     Waldenstrom's Macroglobulinemia.~   "
52412|NCT02371135|"~     The purpose of this study is to understand the role bacteria that normally live in the colon~     may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer.~     The investigators will collect stool specimens as well as additional colon biopsy specimens~     during the patient's scheduled colonoscopy procedure. The investigators will also collect a~     questionnaire about diet and lifestyle. The samples will be used to study the impact of diet~     on naturally-occurring oral and gut bacteria and their influences on human health including~     risk of cancer.~   "
52413|NCT02371122|"~     The purpose of this study is to evaluate the effect of different spinal cord stimulation~     settings in the treatment of leg pain. Subjects will receive a randomized order of four~     different programmed stimulation settings for 3 weeks each followed by a fifth and final~     setting.~   "
52414|NCT02371109|"~     Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken~     vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix~     (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat~     (both called extragenital sites), often with no symptoms. In some people infection will be~     found at more than one site, but in others it will only be in one, and if all anatomical~     sites are not tested some infections will be missed. In certain women one third of~     infections may be missed, in men who have sex with men (MSM) up to 90% may be missed, if~     extragenital swabs are not taken. Currently, routine community testing does not include~     extragenital sites. Until recently these samples could not easily be taken outside clinical~     settings (hospitals, clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs,~     now make this possible.~      However, they are expensive, and taking samples from extragenital sites would treble the~     costs. We propose that swabs from the three sites per person are pooled and analysed~     together rather than tested separately. This method would identify whether the person had~     the infection but not the anatomical site; this would not alter the management of the~     individual. Swabs from the rectum and throat have historically been taken by clinicians~     (doctors or nurses). The main attraction of community screening is that it is client led~     using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and~     throat are acceptable to clients and may be as good as swabs taken by clinicians, but the~     costeffectiveness of this approach has not been investigated. Our aim is to establish~     whether in MSM and females selftaken samples that are pooled and processed by NAATs are as~     effective as the individual tests taken by clinicians.~   "
52415|NCT02370134|"~     This study is aimed to study the feasibility and safety of parkinson's glove that combined 2~     module of tremor detection and tremor suppression with electrical muscle stimulation for~     using as device for rest tremor suppression in parkinson's disease patients~   "
52416|NCT02370121|"~     Gymnema sylvestre has demonstrated promising effects in the treatment of obesity,~     dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings~     show that Gymnema sylvestre has an excellent potential for the prevention and treatment of~     metabolic syndrome.~   "
52417|NCT02370108|"~     This study is aimed to study the safety and feasibility of electrical muscle stimulation~     (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's~     disease.~   "
52418|NCT02370095|"~     Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a~     number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung~     function and breathlessness. There are no pharmacological treatments approved for the~     treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil~     sodium by inhalation for preventing the progression of acute hypoxemic respiratory failure~     to positive pressure ventilation and/or ARDS in patients at high risk.~   "
52419|NCT02370082|"~     The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical~     Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time~     guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon~     locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The~     SAVI SCOUT has been 510K cleared.~      The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a~     non-palpable abnormality as localized by radiographic or ultrasound methods. In this study,~     the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead~     of the standard technique of wire localization.~   "
52420|NCT02371096|"~     Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be~     compared in patients suffering from Rheumatoid Arthritis.~   "
52421|NCT02371083|"~     This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A~     vaginal pessary is a silicone device that is placed in the vagina to support the pelvic~     organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove~     their own pessary on a regular basis. In women who are either unwilling or unable to remove~     their own pessary, complete pessary care is provided in the urogynecology office. Complete~     pessary care involves regular removal and cleaning of the pessary with a vaginal~     examination. In our practice, the investigators typically remove vaginal pessaries and~     examine the vagina every 3 months in patients for whom the investigators provide complete~     pessary care. Interval of pessary removal varies widely between practitioners. In the~     literature, removal intervals vary from weekly to yearly. In this study, the investigators~     will randomize participants to pessary care with removal every 12 weeks or every 24 weeks.~   "
52513|NCT02369809|"~     Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in~     daily clinical practice and obtain information about the quality of life in patients treated~     with Neovasculgen®.~   "
52423|NCT02371057|"~     Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone~     secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint~     destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the~     colon. To have a greater effect on long-term outcomes this disease needs to be detected~     early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be~     able to detect these patients earlier and prevent late complications of the disease. At LTHT~     the referral pathway for new referrals to the sleep apnoea clinic involves initial~     attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These~     readings show approximately 1:4 patients displays evidence of significant obstructive sleep~     apnoea to warrant referral to the treatment group for continuous positive airway pressure~     (CPAP), weight management, and occasionally mandibular adjustment.~      Patients attending the sleep apnoea clinic either as new referral or for review will be~     asked to participate in the proposed study. The study is cross-sectional in design~     incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises~     patients under follow-up known to have sleep apnoea, and the second cohort those patients~     prospectively attending the sleep apnoea clinic for assessment. If after an explanation of~     the study they agree to participate blood will be taken for assessment of IGF-I and they~     will be asked to complete a simple questionnaire.~      The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate~     five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are~     elevated patients will be investigated further for the possibility of acromegaly. The~     presence of biochemically proven acromegaly will be used to determine if the simple question~     has sufficient sensitivity to use as a screening tool.~   "
52424|NCT02371044|"~     The investigators study aims to test the correlation between the CoaguChek point-of-care~     testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently~     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to~     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in~     real-life stroke patients.~   "
52425|NCT02371031|"~     This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for~     improving surgical planning and providing non-invasive prognostic information in patients~     with gliomas that have substantial non-enhancing regions. The results will be used to~     develop larger adequately powered studies.~   "
52426|NCT02371018|"~     The purpose of this study is to examine the effect of nutritional supplementation during~     hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover~     design.~   "
52427|NCT02371005|"~     Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by~     three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological~     abnormalities. As all connective tissues can be affected, this condition has multiple~     effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc~     patients. Oral manifestations have a major impact on quality of life and require specific~     treatments that should be performed as early as possible.~      Widening of the periodontal ligament space, that seems to be linked to an increased collagen~     synthesis, is one of the most common dental radiographic finding. However, this radiologic~     sign has been mostly studied on two-dimensional radiographs. The investigators have recently~     described in a patient suffering from SSc the existence of calcifications within the~     periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al.,~     Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been~     observed before, could be part of the phenotypic spectrum of the disease, in particular when~     dystrophic calcinosis is associated. They could furthermore constitute a specific feature of~     SSc. However, this radiographic sign requires to be investigated in a largest number of~     patients.~      Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that~     elevated CXCL4 serum levels correlate with disease complications, suggesting that this~     molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate~     with SSc severity. Gingival crevicular fluid can be easily collected from the gingival~     crevice surrounding the teeth and constitute an indicator of local but also systemic~     inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the~     identification of specific SSc biomarkers and allow a better comprehension of oral~     manifestations pathogenesis.~      The aim of this case-control study is to characterize precisely the oral manifestations~     associated with SSc within the National Referral Center for Rare Autoimmune Diseases~     (Strasbourg, France) patient cohort in order to identify specific radiological, clinical~     and/or biological signs. Some of them could be correlated to the severity or to the~     prognosis of the disease. To the investigators knowledge it is the first study using~     tridimensional CBCT approach.~   "
52428|NCT02370992|"~     Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and~     intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this~     technique in patients who have had a previous transurethral resection of the prostate gland~     (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience~     when the technique was being developed in the 1980s suggested that there was a higher~     incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It~     is however clear that with increasing experience many centres offer this treatment to~     patients who have had previous TURP, using various parameters to select patients including~     time from the TURP and persence or absence of a significant cavity within the gland on MRI~     scanning. There has been no systematic study of I125 brachytherapy after TURP in the current~     era which might address and inform the practice for future patient. Hence this study is~     designed to formally assess the safety of I125 brachytherapy after previous TURP.~   "
52429|NCT02370979|"~     This is a multi-center prospective study. The primary objective of DRONE study is to~     investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48~     (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG~     pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.~   "
52430|NCT02370966|"~     The purpose of this study is to determine whether intake of berry powder effective in the~     treatment of systemic and oral inflammation.~   "
52431|NCT02370953|"~     OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and~     blindness if untreated. Cataract surgery is the most frequently performed surgical~     intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010~     amounting to a total number of over 160.000 surgeries per year in the Netherlands.~      Approximately 22% of patients with cataract have a substantial pre-existing corneal~     astigmatism. Toric IOLs provide the opportunity to correct pre-existing astigmatism,~     offering the patients optimum distance vision without the use of spectacles or contact~     lenses. Toric IOLs are increasingly used in cataract and refractive surgery.~      Since the introduction of toric intraocular lenses (IOLs) in the treatment of cataract in~     patients with pre-existing corneal astigmatism, numerous studies have shown the importance~     of accurate positioning of the toric IOL to the intended alignment axis. An error of 5º in~     toric IOL alignment will decrease the anticipated effect by 17% and thus misalignment will~     decrease the effectiveness of the astigmatism treatment. There are several methods used to~     align the toric IOL at the intended axis. Most of these use a 3-step ink-marking procedure~     and are performed manually. Clinical study showed an average error of 5º in toric IOL~     alignment when using this method.~      Two new tools that have recently been introduced to the market are the VERION Measurement~     Module and VERION Digital Marker. Together, these tools provide integrated digital guidance~     for alignment of toric IOLs and they have the potential to eliminate the error in horizontal~     axis marking and the alignment axis marking error. This will lead to an improved visual~     outcome. So far, there are no published studies using the VERION tools for toric IOL~     alignment in cataract surgery. Therefore, the investigators will perform this randomized~     control trial.~      MAIN HYPOTHESIS~      The investigators hypothesise that cataract surgery with the implantation of a toric IOL,~     when using the VERION-tools, compared to manual ink-marking, in patients with corneal~     astigmatism will lead to:~      - An increase in accuracy in toric IOL alignment~      OBJECTIVES~      Primary Objective:~      The primary objective of the study is to compare the accuracy in toric IOL alignment when~     using the VERION-tools for alignment of the toric IOL or the conventional manual ink-marking~     procedure.~      Other hypotheses and objectives are available in the detailed description.~   "
52432|NCT02370940|"~     The purpose of this study is to investigate whether regular consumption of phytate dampens~     its negative effect on nonheme iron absorption.~   "
52433|NCT02370927|"~     The objectives are to test the acute effects of different cereals containing pulse~     ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of~     blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two~     hours following the exercise session. The investigators hypothesize that consumption of~     cereals containing pulse ingredients 60 minutes before exercise will increase aerobic~     endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory~     quotient), and a reduction in lactate production during compared to the same exercise~     session following the ingestion of a non-pulse food. The investigators also hypothesize that~     consumption of cereals containing pulse ingredients will lead to lower blood glucose,~     insulin, appetite and food intake, suggesting lower calorie compensation, following a~     60-minute aerobic exercise session compared to the same exercise session following the~     ingestion of a non-pulse food.~   "
52434|NCT02370914|"~     The purpose of this study is to establish and evaluate a distinctive signal for concussion.~   "
52435|NCT02370901|"~     Babies 4-7 months of age with positional plagiocephaly will be treated with repositional~     techniques verse helmet therapy. The helmet therapy children will be fitted a helmet at~     Westcoast Brace and Limb and monitored during treatment to ensure proper fitting of helmet.~     The repositioning children's parents will given instructions on how to perform neck~     stretching exercises and repositioning techniques and monitored during treatment. The~     anthropometric measurements will be done by licensed orthotist at monthly intervals for a~     total of six months of treatment. Before treatment, 6 months, 12 months, and 24 months from~     treatment all of the children will be scanned by Star Scanner (Orthomerica) to provide~     objective measurement of the cranial vault asymmetry and index.~   "
52436|NCT02370888|"~     The purpose of this study is to determine the maximum tolerated dose, dose limiting side~     effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who~     have a small amount of detectable disease after allogeneic stem cell transplant.~   "
52437|NCT02370875|"~     Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum~     neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial~     magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown~     positive benefits in BEB. rTMS therapy can be easily combined with BoNT injections to~     enhance the effects of BoNT in BEB.~   "
52438|NCT02370862|"~     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most~     individuals with SCI. Previous studies have reported that the average time to complete a BC~     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1~     hour. In past studies, the investigators have shown that a medication called neostigmine~     (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and~     thus, promote bowel movement. The investigators have successfully used this medication with~     traditional and novel methods of colonoscopic preparations, and have shown that it improves~     the quality of these preparations. In this Phase I, proof of concept pilot study, the~     investigators propose to study the effectiveness of this medicine when it is delivered~     through the skin. In order to make delivery more efficient, the investigators will be using~     a technique called iontophoresis, which uses a mild electric current to drive the drug~     through the surface of the skin. The instrument includes an electrode containing the active~     agent (delivers charge) and an oppositely charged electrode (receives charge) which will be~     placed on the surface of the skin. The study design will consist of a screening visit to~     determine each individual's response to a previously established IV dose of NEO and GLY,~     followed by a dose titration study (two visits) of iontophoresed NEO and GLY. Study visits~     will be separated by no less than 2 days and no more than 14 days.~      If this delivery method is shown to be effective, it may represent a way to vastly improve~     the clinical utility of this medication by allowing for needle-free self administration, and~     expanding the clinical indication to routine, at home bowel care.~   "
52439|NCT02370849|"~     In this open-label, single-center, small sample size, randomised, parallel-group, controlled~     study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS~     chemotherapy in patients with previously untreated advanced gastric adenocarcinoma.~     Sixty-two patients are required and randomly assigned (1:1) to each group.~      The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for~     advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.~   "
52440|NCT02370836|"~     This study evaluates that effects of psycho-oncological education on distress and quality of~     life in solid tumor cancer patients who have completed chemotherapy with curative intent.~     Half of the participants will received a psycho-oncological educational intervention while~     the other half will receive usual care.~   "
52441|NCT02370823|"~     The primary objective of this study is to determine the levels of proteins and/or cellular~     components of the synovial fluid that are indicative of microenvironment phenotypes of the~     osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks~     post-Regenexx® SD treatment.~   "
52442|NCT02370810|"~     The purpose of this study is to determine the feasibility and effectiveness of a CBT-based~     internet intervention for adults with tinnitus in the United Kingdom~   "
52443|NCT02370797|"~     The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron~     Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as~     good or better results in preventing recurrence of local breast cancer, cosmetic appearance~     and early and late side effects.~   "
52444|NCT02370784|"~     The purpose of this study is to learn about the effect atorvastatin on blood vessel function~     and Raynaud symptoms in patients with early diffuse systemic sclerosis.~      Systemic sclerosis is a disease characterized by blood vessel injury, immune system~     activation and fibrosis. Blood vessel injury is thought to be important early in the~     disease. Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger~     and toe ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is~     recognized to have many effects beyond cholesterol reduction. These include improvement of~     blood vessel function and reduction of fibrosis. We hypothesize that treatment with~     atorvastatin over 16 weeks will improve blood vessel function and Raynaud symptom in~     patients with early diffuse systemic sclerosis. We hope that by targeting therapy early in~     the disease we may delay blood vessel changes and improve Raynaud symptoms.~   "
52445|NCT02370771|"~     Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the~     elderly population. Usually considered as a minor illness, it nevertheless leads to an~     important functional impairment. The mechanism of this disease is still poorly known.~     Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis~     from which mechanisms may differ.~      Methods:~      This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in~     consultation of rheumatology and plastic surgery in Rouen University Hospital.~      Two groups of patients will be studied: 20 patients with non erosive subtype of hand~     osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.~      A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic~     analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.~   "
52446|NCT02370758|"~     This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated~     immunity can be used to determine whether patients who complete a course of therapy for CMV~     viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will~     receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their~     prophylaxis stopped.~   "
52447|NCT02370745|"~     This study has two protocols the aims of which are:~        1. To identify age-related effects of AA on incretin secretion and whether and to what~          extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in~          younger individuals. (Protocol 1)~        2. To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like~          peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and~          microvascular blood flow. (Protocol 2)~   "
52448|NCT02370732|"~     The proposed project will help to understand the changes in reinforcement and impairment~     experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this~     study the investigators propose to investigate RYGB patients with a prospective,~     longitudinal design. Investigators will examine driving impairment before and after surgery~     as well as study cognitive changes and reinforcement changes that may occur in RYGB patients~     while consuming alcohol. Finally, investigators aim to better characterize the changes that~     occur in the pharmacokinetics of alcohol following bariatric surgery and examine key~     variables which may play a role in the development in alcohol use disorders.~   "
52449|NCT02370719|"~     The purpose of this study is to evaluate a patient-centered diabetes self-management mobile~     application (app), which was developed with feedback from both patients and healthcare~     providers. During the 12 month randomized control trial, participants in the intervention~     group will be provided with a mobile phone and commercial home medical devices, such as a~     weight scale, glucometer and activity monitor. The measurements taken from the medical~     devices will wirelessly transfer to the mobile phone, where the app will assess the data and~     provide patients with actionable self-management knowledge. The proposed intervention may be~     helpful in increasing adherence to recommended self-care practices, improving self-efficacy,~     and enhancing the overall patient experience.~   "
52450|NCT02370706|"~     This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the~     triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for~     the doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with~     myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics~     (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including~     changes in spleen volume, JAK2V617F allele burden, and hematologic response.~   "
52451|NCT02370693|"~     The purpose of this study is to look at whether bortezomib, mycophenolate or the combination~     of both is better to treat scarring of the lung caused by Systemic Sclerosis.~   "
52452|NCT02370680|"~     This study is being conducted to evaluate the safety and the length of effect on platelet~     build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg~     or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus~     and cardiovascular disease or multiple risk factors of developing cardiovascular disease.~   "
52453|NCT02370667|"~     Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain~     management, improved function, and chronic disease prevention. Exercise that decreases joint~     exposure to damaging loading while eliciting adequate muscular activation for strength~     improvements is ideal. The purpose of this 3-arm RCT is to compare mobility, strength, pain,~     and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional~     exercise program for knee OA (TE), and a control group completing meditation classes (M).~   "
52454|NCT02370654|"~     This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise~     in pulmonary rehabilitation for COPD patients. Half of participants will receive the~     Chen-style Tai Chi intervention, while the other half will receive the conventional exercise~     intervention. Both groups will receive the same eduction and support during pulmonary~     rehabilitation.~   "
52455|NCT02370641|"~     A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The~     excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine~     after one dose of POMx. A blood sample and stool sample will be obtained before~     administering the extract. Subjects will be asked to consume one capsule of 1000 mg POMx~     daily for 4 weeks. At day 28, a blood sample, 24 hour urine sample will be obtained, and the~     stool collected by the participant in the prior 24 hours will be returned to the Center.~     Blood and urine urolithin, ellagic acid levels and stool bacteria enumeration and~     identification (including pyrosequencing) will be measured with the samples collected. A~     stool DNA sample will be preserved and frozen for potential future measurement of~     gene-nutrient interaction in pomegranate metabolism.~      Throughout the study participants will be instructed not to consume pomegranate products,~     walnuts, or polyphenol-rich fruits ((strawberry, raspberry etc) or juices drawn from a list~     used in prior studies. The study will be carried out in accordance with the guidelines of~     the Human Subjects Protection Committee of the University of California, Los Angeles. All~     subjects will give written informed consent before the study begins. Participants will be~     recruited by advertisement in the local newspaper in the Los Angeles Area close to UCLA.~   "
52514|NCT02369796|"~     The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of~     subcutaneous dose administration, with different doses and dosing frequencies of TAK-448 to~     overweight/obese males with hypogonadotropic hypogonadism (HH).~   "
52456|NCT02370628|"~     The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing~     percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful~     vertebral compression fractures.~      The treatment offered for vertebral compression fractures (VCFs) in the interventional arm~     of the trial is vertebroplasty, which will be performed in accordance with the standardized~     protocol of the Canadian Association of Radiologists. Patients in the control arm will~     receive facet block, where a long-acting local anesthetic agent and corticosteroids are~     injected in the spinal articular facets at the affected level.~   "
52457|NCT02370615|"~     The purpose of this study is to evaluate the effect of repeated-dose administration of~     itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose~     administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy~     Japanese adult males.~   "
52458|NCT02370602|"~     The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain~     following a single dose of TAK-063.~   "
52459|NCT02370589|"~     This is a randomized, observer-blind, placebo-controlled trial in male and female subjects~     ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical~     examination, and baseline clinical laboratory testing.~      Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups.~      Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate~     deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with~     or without Matrix-M adjuvant), in a 0.5mL injection volume.~   "
52460|NCT02370576|"~     Determination of incidence and prevalence of PTSD and other types of psychopathology (such~     as anxiety and affective disorders) after traumatic birth experiences and elucidation of~     salient risk factors in the local population sample- by prospective follow-up.~   "
52461|NCT02370563|"~     The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or~     metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This~     is a single center, open labelled, non-randomized study. A total of 30 subjects with brain~     tumor or brain metastases will be enrolled. All different stages of malignancies will be~     recruited, including those with different types of pathologies and grades, and newly~     diagnosed or recurrent disease.~   "
52462|NCT02370550|"~     The purpose of this large multicenter, randomized, double-blinded, controlled clinical study~     is to investigate the efficacy and safety of Cyclosporin A for primary Sjogren's syndrome~     associated pneumonitis(pSS-IP), which has important implications for the establishment of~     standardized diagnosis and treatment of pSS-IP.~   "
52463|NCT02370537|"~     This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase~     II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients~     with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of~     EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott~     Healthcare Products Ltd) following a single oral dose in patients with different degrees of~     PEI.~   "
52464|NCT02370524|"~     The primary objective of this exploratory imaging study is to further characterize~     [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream~     biomarker indicative of neurodegeneration in conditions such as AD).~   "
52465|NCT02370511|"~     The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN~     XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific~     mitral valve disease with severe mitral annular calcification who are not candidates for~     standard mitral valve surgery.~   "
52466|NCT02370498|"~     This is a study for participants with advanced gastric or gastroesophageal junction~     adenocarcinoma who have had tumor progression after first-line treatment with platinum and~     fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab~     prolongs progression free survival (PFS) and overall survival (OS) for participants with~     tumors that show positive programmed cell death ligand 1 (PD-L1) expression.~   "
52467|NCT02370485|"~     The purpose of this study is to evaluate how much of the LY2801653 drug is available in the~     body when given in 2 different formulations with and without a meal to healthy participants~     who are not able to have children. In addition, this study will measure how much of the drug~     gets into the blood stream and how long it takes the body to get rid of it. Information~     about any side effects that may occur will also be collected. The study will last about 27~     days. Screening is required within 28 days prior to the start of the study.~   "
52468|NCT02370472|"~     The use of Ultrasound Guided Regional Anaesthesia (USRA) has increased over the last decade.~     Theoretically, ultrasound imaging may increase efficacy and safety by allowing visualization~     of the needle pathway and local anaesthetic spread around the nerve. In addition to~     knowledge of anatomy and general principles of ultrasonography, USRA requires learning new~     skills such as image interpretation, needle-beam alignment, and needle trajectory tracking.~     The hand-eye coordination required during needle advancement requires practice to master~     because the needle must be properly aligned with the ultrasound probe in order to maintain~     the needle path in the beam at all times. Adding to the difficulty, hand and needle~     movements can occur in three axes, but an ultrasound image is seen in only two dimensions.~     Since the ability to acquire the necessary skills to perform USRA is subjective and not yet~     validated, it is difficult to recommend a single, effective training pathway.~      Currently, the only method of supervised training before performing an USRA procedure on an~     actual patient involves practicing needle insertion in a phantom or cadaver. Studies~     assessing the impact of learning using these methods are lacking. It is possible that some~     practitioners may choose alternative one-off learning methods. Such methods are not~     standardized and are thus difficult to evaluate.~   "
52478|NCT02370342|"~     This clinical trial studies a type of ultrasound called robot-assisted laparoscopic~     high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave~     therapy, in treating patients with small kidney masses undergoing partial removal of the~     kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors~     locate the mass. The probe then uses high frequency sound waves to target and ablate (or~     destroy) the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then~     performed to remove the part of the kidney with the mass. Robot-assisted laparoscopic~     high-intensity focused ultrasound for thermal ablative therapy may be safer and help doctors~     see the tumor better when performing kidney surgery.~   "
52469|NCT02370459|"~     The University of North Carolina will test the effectiveness of the Centers for Disease~     Control and Prevention's AFIX model for increasing HPV vaccination coverage among~     adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality~     improvement consultations that immunization specialists from state health departments~     deliver to vaccine providers in primary care settings. Using immunization registry data, the~     specialist evaluates the clinic's vaccination coverage and delivers education on best~     practices to improve coverage. We will compare changes in HPV vaccination coverage before~     and after consultations for high-volume pediatric and family medicine clinics across three~     study conditions: traditional consultations (in-person group), virtual consultations~     (webinar group), or no consultations (control group). In each participating state, 30~     clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or~     270 clinics overall. The primary objective of this study is to compare the change in~     coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month~     follow-up. Secondarily, we will compare the change in coverage for other vaccines and age~     groups.~   "
52470|NCT02370446|"~     The purpose of this study is to see if using the MedLog is helpful to patients. Since the~     investigators do not yet know if this MedLog is helpful, some patients will receive it and~     some will receive our standard of care. The investigators want to know whether providing~     patients with this additional information is helpful and if having this additional~     information about their treatment schedule has an effect on their quality of life.~   "
52471|NCT02370433|"~     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most~     individuals with SCI. Previous studies have reported that the average time to complete a BC~     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1~     hour. In past studies, the investigators have shown that a medication called neostigmine can~     increase bowel activity and thus, promote bowel movement. The investigators have~     successfully used this medication with traditional and novel methods of colonoscopic~     preparations, and have shown that it improves the quality of these preparations. In this~     study, we would like to test the applicability of this medication to bowel care routines.~      The investigators believe that the addition of this medication to the beginning of regular~     bowel regiments will significantly decrease the time and effort needed to complete BC, thus~     improving patient perception of their BC routines and quality of life. SCI individuals~     followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted~     on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such~     inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient~     undergo BC routines assisted by the inpatient care team. BC routines are typically performed~     every other day, or thrice weekly (Monday, Wednesday, Friday) in Blue Rooms located on the~     inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure,~     use of assistive medications or devices, and completeness of bowel care are documented in~     the patients' electronic medical chart (CPRS) by care providers. The investigators propose~     to perform the described protocol in individuals who have been admitted to the hospital for~     routine care and are otherwise healthy. In doing so, the investigators can ensure that~     patients are vigilantly monitored during each BC session, and that any changes in BC pattern~     are accurately observed and documented. Furthermore, by performing these procedures on an~     inpatient basis, study investigators can ensure the consistency of care and daily routine,~     allowing for better control of study conditions.~   "
52472|NCT02370420|"~     The investigators include patients attending the outpatient clinic in the area of~     Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee~     osteoarthritis, which treatment is medical. Patients will be divided into two groups. In~     both groups, they will be given verbal, clear and detailed information on the approach to~     follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus~     rehabilitation exercises. In the first group will be held single application, while in the~     second group three applications will be made at an interval of two weeks each. Both groups~     will be assessed before and after application, together with outpatient follow-up by the~     SF-12, WOMAC and Visual Analogue Scale.~   "
52473|NCT02370407|"~     This is a randomized controlled trial that will randomize 40 surgical skill naive medical~     students to practice on a robotic simulator or laparoscopic simulator after first completing~     a baseline evaluation on both surgical simulation platforms. Medical students will be~     evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to~     assess transferability of skills between the surgical simulation platforms.~   "
52474|NCT02370394|"~     The study will develop and assess an innovative, high-reach, easily implementable, low-cost~     computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that will~     address known barriers in early identification and intervention with perinatal women with~     IPV seeking treatment for mental illness.~   "
52475|NCT02370381|"~     Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood~     loss and the current hemoglobin of patients. In patients with oral anticoagulation, it is~     important to measure the level of hemodilution. Several situations with the importance of~     the fast determination of these parameters have been identified in previous studies [1,2].~     The blood sampling from the venous punction is the standard in these investigations.~     However, this requires the corresponding painful puncture and also the time required at the~     laboratory.~      Since many patients present themselves with active bleeding, it is obvious that this blood~     could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose~     blood can be analyzed with commercial rapid test devices. If these devices could generate~     same or similar results and after further validation of the method, painful punctures could~     be waived.~   "
52476|NCT02370368|"~     This study will examine the effects of six week dance training, using the Xbox Kinect Just~     Dance 2014 programme, on the agility scores along with general and hamstring flexibility and~     extensibility of the hip flexor. The effects of the dance programme will be compared with~     those of proven agility training techniques (ladder drills).~   "
52477|NCT02370355|"~     This research trial studies molecular characterization of circulating tumor cells (CTCs) and~     circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients~     with prostate cancer that has spread to other places in the body and/or has not responded to~     previous treatment with hormones. Studying samples of blood and plasma collected from~     patients with prostate cancer before, during, and/or after treatment in the laboratory may~     help doctors learn more about changes that occur in DNA and identify the development of drug~     resistance.~   "
52479|NCT02370329|"~     This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon~     alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a~     substance that can improve the body's natural response and may slow the growth of~     myelofibrosis.~   "
52515|NCT02369783|"~     The main objective of the study is to validate a methodology with Psychometric tool to~     measure levels of patients social fragility.~      This tool will be dematerialized on a tablet. The answers will be then processed by a~     decision support algorithm, which automatically send an alert to detection of social~     fragility of the patient to the nurse navigators.~   "
52480|NCT02370316|"~     The present randomised clinical trial aims to assess the clinical and neurobiological~     changes following Metacognitive Interpersonal Therapy -standard approach (MIT-SA) compared~     with Clinical Structured Treatment (CST) derived from specific recommendations in APA~     guidelines for borderline personality disorder (BPD). The investigators will assess clinical~     changes in metacognitive abilities and in emotion regulation and changes in brain activation~     patterns at the resting state and while they view emotional pictures. A multidimensional~     assessment will be performed at the baseline, at 6, 12, 18 months. The investigators will~     take structural and functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N=30)~     and CST-treated BPD (N=30) at baseline and after treatment, as well as a group of 30 healthy~     and unrelated volunteers that will be scanned once for comparison. Furthermore, blood~     analyses will be done in order to assess level of BDNF and some hormone levels (oxytocin and~     vasopressin) before and after treatments.~   "
52481|NCT02370303|"~     The purpose of this study is to isolate and measure circulating tumor cells in the blood~     stream to advance detection of cancer and treatment monitoring. In this study, the~     investigators will utilize the novel technology for circulating tumor cell detection in~     order to evaluate their presence in patients with lung cancer.~   "
52482|NCT02370290|"~     This pilot research trial studies quantitative imaging metrics derived from contrast~     enhanced computed tomography (CECT) in enhancing assessment of disease status in patients~     with kidney cancer. Quantitative imaging is the extraction of quantifiable features from~     radiological images for the assessment of disease status. Collecting quantitative imaging~     metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade~     (tumor stage) and assess treatment response and prognosis in cancer imaging.~   "
52483|NCT02370277|"~     This pilot research trial studies the effects of chemotherapy on intestinal~     bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in~     intestinal microbiota may be associated with weight gain in patients treated with~     chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the~     types and quantity of bacterial composition in the stool of breast cancer patients treated~     with chemotherapy may help determine whether body weight and composition are associated with~     changes in the intestinal microbiota and allow doctors to plan better treatment to prevent~     weight gain and possibly disease recurrence.~   "
52484|NCT02370264|"~     This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck~     (upper extremity) function and quality of life after treatment in patients with breast~     cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect~     their functioning and quality of life after cancer-related treatment. Studying upper~     extremity function and quality of life in patients after breast cancer treatment may help~     doctors determine the prevalence and severity of long-term functional impairments and the~     relationship between the perception of impairments due to breast cancer treatment and its'~     impact on quality of life.~   "
52485|NCT02370251|"~     This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at~     treating liver disease in children on long-term IV nutrition.~   "
52486|NCT02370238|"~     Reparixin oral tablets are being tested as a CSC targeting agent in patients with metastatic~     non- human epidermal growth factor receptor (HER2)-amplified BC. An open label Phase 1b~     clinical study (REP0111) is ongoing (enrollment completed) in five US sites, under IND #~     112502, to test safety, tolerability, pharmacokinetics and detect early signs of antitumor~     activity of increasing doses of reparixin oral tablets in combination with a fixed dose of~     weekly paclitaxel. The study has demonstrated safety and tolerability of the combination~     across the three dose levels explored and recorded objective responses in the published~     range for single agent weekly paclitaxel in the target population. The highest dose level~     explored (i.e., 1200 mg t.i.d.) was identified as the recommended phase 2 dose. Durable~     responses have been recorded in patients with TNBC.~      The current phase 2 study thus aims to evaluate the Progression Free Survival of patients~     with metastatic TNBC [relapsed following (neo)adjuvant chemotherapy] receiving reparixin in~     combination with paclitaxel versus paclitaxel alone.~   "
52487|NCT02370225|"~     The purpose of this sudy is to investigate the effects of a regular aerobic exercise on~     aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease~     activity in women with pSS.~   "
52488|NCT02370212|"~     Recent evidence suggests that high -intensity interval training (HIIT) may be an effective~     strategy to improve cardiorespiratory fitness, exercise performance, and insulin~     sensitivity. In addition, creatine (Cr), a nitrogen- containing compound, is widely used to~     enhance high intensity exercise performance. A seminal study demonstrated that the muscle~     content of Cr and phosphocreatine (PCr) can be elevated by exogenous Cr. Oral intake of Cr~     increases the concentration in blood and muscle, and part of the increased muscle Cr is~     transformed to PCr (a process catalyzed by Cr kinase). Cr supplementation increases total Cr~     (TCr = Cr + PCr) by ~20%, with the PCr component accounting for 10% of the increase.~      Combining HIIT and Cr is intriguing for two reasons; first, Cr supplementation improves~     performance through increasing PCr, PCr recovery, and muscle buffering which may facilitate~     higher training intensities and therefore greater training adaptations. Secondly, both Cr~     and HIIT have individually been shown to increase GLUT 4 and insulin sensitivity, suggesting~     that Cr supplementation may be an adjunct to HIIT for improving glucose control. To date,~     there have only been two studies investigating the performance effects of Cr combined with~     HIIT with preliminary positive results. No studies have examined the impact of combined Cr +~     HIIT on outcomes related to insulin sensitivity. Therefore, the purpose of this research is~     to examine the combined effects of Cr and HIIT on performance and insulin sensitivity as~     determined via an oral glucose tolerance test (OGTT) in young healthy adults.~   "
52489|NCT02370199|"~     This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes~     in healthy adults. All participants will receive red light to their leg. They will also~     receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.~   "
52500|NCT02369991|"~     This study assesses the long-term results of compound tibial reconstruction treated with a~     microvascular latissimus dorsi flap and bone transport technique during the last 25 year in~     Helsinki University central Hospital.~   "
52834|NCT02365584|"~     The primary objective of the study is to evaluate the impact on quality of life of~     Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard~     care alone, in subjects affected by inoperable malignant bowel obstruction.~   "
52490|NCT02370186|"~     Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths~     annually in the US. Currently there are no effective drug therapies for sepsis. High density~     lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is~     protective in sepsis. Its functions in sepsis are primarily mediated by its main~     apolipoprotein, Apo-A1, that: 1) neutralize potent bacterial toxins, 2) protect blood vessel~     walls from damage, 3) prevent tissue damage through antioxidant properties, and 4) mediate~     thymocyte apoptosis (critical for survival) and endogenous corticosteroid release. However,~     recent literature presents inconsistent data on HDL functionality and shows that HDL becomes~     non-functional during acute inflammatory states called dysfunctional HDL (Dys-HDL). Several~     causes for Dys-HDL have been hypothesized including the presence of Apo A1 polymorphisms,~     which may worsen the pathologic inflammatory response in sepsis and have been demonstrated~     in early sepsis, making Dys-HDL an unstudied potential early marker. This project aims to:~     1) determine the presence of Dys-HDL in adult patients with early severe sepsis who present~     to the ED (Dys-HDL will be tested using a novel cell free assay and HDL Inflammatory Index~     will be measured), and 2) examine the relationship between Dys-HDL and cumulative organ~     dysfunction via Sequential Organ Failure Assessment (SOFA) score. Results of this study~     could establish Dys-HDL as an early disease marker for sepsis which is influential in the~     development of sepsis-induced organ dysfunction.~   "
52491|NCT02370173|"~     Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major~     problem among service members returning from combat deployments. The proposed study aims to~     test a novel, inexpensive, and easy to use approach to improving sleep among service members~     with PTSD.~      Primary outcome measures will include not only PTSD symptom improvement but also include~     neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The~     proposal is firmly grounded in the emerging scientific literature regarding sleep, light~     exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light~     therapy is effective for improving mood and fatigue, and our pilot data further suggest that~     this treatment may be effective for improving daytime sleepiness and brain functioning in~     brain injured individuals. Thus, this intervention, in our own research and in the work of~     others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a~     vital component of recovery in these service members. Our approach would directly address~     this issue. Our preliminary data have shown that this approach is extremely well tolerated~     and is effective for improving sleep, mood, cognitive performance, and brain function among~     individuals with brain injuries.~      Finally, the potential impact of this study is high because of the capability of~     transitioning the research to direct clinical application almost immediately. If the bright~     light treatment is demonstrated as effective, this approach would be readily available for~     nearly immediate large-scale implementation, as the devices have been widely used for years~     in other contexts, are already safety tested, and commercially available from several~     manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would~     be high and immediate.~   "
52492|NCT02370160|"~     To determine if the maximum tolerated dose (MTD) of DT2219ARL on an eight dose schedule.~   "
52493|NCT02370147|"~     A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be~     proposed in outpatient department clinics of People's Liberation Army General Hospital in~     Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief~     face-to-face individual smoking reduction intervention lasted about one minute, and five~     follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very~     brief face-to-face individual exercise and dietetic advices lasted for the same intervention~     time as SRI, and also five follow-up interventions lasted for one minute each with different~     intervention contents.~   "
52494|NCT02370069|"~     Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to~     their immune system being suppressed. Pneumococcal infection is particularly common and~     often results in death due to inflammation of lung (pneumonia) or the whole body (sepsis).~     This infection can be prevented using vaccines which help build protective immunity. The~     currently recommended pneumococcal vaccine (Pneumovax), however, is often inefficient in~     this group of patients. There is thus an urgent need to improve the existing vaccination~     policy.~      The goal of this research is to optimize pneumococcal vaccination of patients with severe~     CKD. Many patients suffering from CKD have already been vaccinated with Pneumovax. Because~     this vaccine has low immunogenicity in immunocompromised individuals, they may still develop~     infection. A new vaccine, Prevnar13, has superior immunogenicity and has been recently~     approved for immunization. There is, however, no specific policy regarding immunization of~     adult CKD patients, and it is furthermore unknown whether previous Pneumovax immunization~     negatively affects immune response to Prevnar13.~      In order to test whether previous immunization with Pneumovax affects the immune response of~     severe CKD patients to Prevnar 13, the investigators will immunize two groups of adult stage~     4 and 5 CKD patients with one dose of Prevnar 13 and will assess their initial immunological~     response, its longevity, and vaccine safety. The first group will consist of patients who~     had been previously immunized with Pneumovax, and the second group will include participants~     with no history of pneumococcal vaccination.~      Antibody levels and opsonophagocytic activity (OPA) will be quantified. The longevity of the~     immune response will be assessed. As a secondary objective, the immune response will be~     analyzed in the context of demographic and clinical characteristics of the vaccinated~     participants.~   "
52495|NCT02370056|"~     The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater~     accuracy and speed in manual skills, translating to decreased operative time, reduced~     learning curve, and superior safety.We aimed to determine the feasibility of the~     laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis~   "
52496|NCT02370043|"~     The purpose of this study is to assess the safety, tolerability, and the effect of food on~     KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different~     dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels~     may be studied, in two distinct groups or cohorts.~   "
52497|NCT02370030|"~     Triple blind placebo-controlled study to determine if administering citrulline in patients~     with sepsis and severe sepsis slows progression to multiple organ failure and death,~     measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or~     citrulline and followed up for 1 month.~   "
52498|NCT02370017|"~     The object of this study is to identify the combined effect of ANKL and doublet chemotherapy~     in advanced NSCLC. The investigators design the combination of ANKL and approved~     chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2~     induction as the first line chemotherapy. ANKL (2x10*9) from peripheral blood 32ml is~     administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK~     cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response~     evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more~     partial response (PR, increased by 15% or more from historical control 25%) is the expected~     target and Simon's two stage design will be applied through the study (power 80%, a= 0.95,~     N1= 33, N= 68)~   "
52499|NCT02370004|"~     The aim of the study is proof of concept and to establish the feasibility of performing a~     study of resistive flexibility and strength training (RFST) in patients with asthma, with~     the future goal of designing a larger randomized trial to test the hypothesis that RFST~     leads to greater improvement in asthma symptoms, pulmonary function tests, range of motion~     and connective tissue mobility compared with a control conventional physical therapy~     intervention.~   "
52501|NCT02369978|"~     This randomized, blind, parallel-group trial will evaluate the efficacy and safety of~     Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite~     Trypanosoma cruzi.~      The investigators will test whether NFX is an effective trypanocidal agent (by comparison~     with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related~     and safety outcomes.~      Individuals found seropositive and without clinical signs of dilated cardiomyopathy will~     receive either of the active treatments or matching placebo. Participants allocated to NFX~     or BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment,~     whereas the control group will receive placebo for 120 days. There will be thus four arms of~     active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving~     placebo (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days~     of study drug (the groups receiving full-dose will complete a 120-day masked treatment with~     placebo).~      The study plans to enroll 500 participants from Colombia (in two different geographical~     areas) and Argentina, in order to explore regional differences in the treatment effects.~   "
52502|NCT02369965|"~     The purpose of this study is to determine the efficacy and safety of albuvirtide plus~     lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.~   "
52503|NCT02369939|"~     Randomized study to investigate the efficacy of deep regional hyperthermia in patients with~     anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.~   "
52504|NCT02369926|"~     This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home~     implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial~     stage, participants are required to travel to the study site one day a week for three weeks~     to complete the MSFC. They are also required to complete the MSFC at home once weekly for~     three weeks using remote sensing technology and video conferencing.~   "
52505|NCT02369913|"~     This proposal is designed to test the hypothesis that humans shift to reliance on ketone~     bodies as a cardiac fuel source during the development of HF. The investigator also propose~     that this shift to ketone utilization can be detected by metabolomic profiling of blood.~      Specific Aim 1: To determine if the failing human heart exhibits increased extraction of~     blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and~     central venous blood samples to determine AV differences. The HF group will be comprised of~     patients undergoing cardiac resynchronization therapy with an implantable~     cardioverter-defibrillator. The Control group will be compromised of patients without~     evidence of structural heart disease who are undergoing catheter ablation for~     supraventricular tachycardia.~      Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic~     signatures indicative of increased myocardial ketone body utilization. Quantitative targeted~     metabolomics will be performed on the samples described in Aim 1 to determine if metabolite~     markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with~     increased myocardial ketone body oxidation in animal models are increased in the human HF~     group compared to the controls.~   "
52506|NCT02369900|"~     The main purpose of this study is to determine the effects of controlling the heart rate of~     patients with septic shock using an intravenous medication called esmolol.~   "
52507|NCT02369887|"~     This is a prospective observational cohort study that aims to enroll a total of 2000 Thai~     MSM and TG at five health facilities in four provinces of Thailand. Each participant will be~     followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4~     counts, retention in care, and ART adherence at the study clinics, at the study clinics~     combined, and national data (if available) will be compared with rates after implementation~     of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence~     and incidence. This study will use similar objectives, indicators, and procedures as those~     used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three~     tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations~     Implementation Science (KPIS) funding through United States Agency for International~     Development (USAID), in community-based centers, allowing comparison of uptake and follow-up~     of MSM and TG using the Test and Treat strategy in a variety of settings.~   "
52508|NCT02369874|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy~     versus SoC therapy in the target patient population.~   "
52509|NCT02369861|"~     Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history,~     ophthalmic examination to include the status of their ocular structure and function and~     evaluation of tear production. Blood will be blood drawn for complete blood count and~     chemistry panel. They will also have a urinalysis and pregnancy test in women of~     child-bearing potential.~      Subjects will have a two week run-in period in which they use artificial tears. If their~     Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will~     receive study drug.~      Safety evaluation includes assessment of the structure and function of the eyes including~     retina examination and corrected visual acuity.~      Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of~     two treatment arms, ACCS or artificial tears eye drops. The randomization scheme is 1:1~     ACCS:artificial tears. Subjects will self-administer their eye drops four times each day.~      Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week~     zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each~     visit. The baseline eye tests and lab work will be repeated after the treatment phase of the~     study at the end of week six. Following 6 weeks of treatment, the subjects will be followed~     for 4 additional weeks.~   "
52510|NCT02369848|"~     Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical~     study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System~     in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm~     reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated~     to generate sonic shockwave energy within the target treatment site and disrupt calcium~     within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low~     balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to~     yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up~     rate.~   "
52516|NCT02369770|"~     This research study will conduct a double-blind randomized clinical trial of an intensive~     motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation~     robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments,~     and improve balance and gait functions. This clinical trial will be conducted on the study~     and control groups of acute stroke survivors.~   "
52517|NCT02369757|"~     The main objective is to evaluate the impact of the recruitment and training of a~     peer-navigator on the participation rate of colorectal cancer screening among underserved~     area. The role of the navigator is to establish an intervention culturally-tailored to the~     inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the~     inhabitants to complementary exams, if needed.~   "
52518|NCT02369744|"~     Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency~     Department (ED) visits. These stones can get caught in the ureter (the tube connecting the~     kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as~     the obstructing stone meets certain conditions and the patient isn't too sick, the patient~     is usually sent home to try and pass the stone without surgery. This treatment is known as~     medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin,~     which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a~     drug in the same class of tamsulosin, but which is thought to have a more selective action~     and a quicker onset, which would theoretically make it better for aiding in kidney stone~     passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs~     to see how quickly they result in stone passage. Subjects are patients presenting to the ED~     with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study~     intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is~     that silodosin will have decreased time to stone passage compared to tamsulosin.~      Subjects who qualify and consent are randomized to a two-week course of either silodosin or~     tamsulosin. They are also given prescriptions for standard of care medications for pain and~     nausea, as well as a pain diary. They receive a follow-up phone call after one week to~     remind them of their follow-up appointment, ask about adverse events, and determine if their~     stone has passed. They have a follow-up visit with study staff at the end of their two week~     treatment to collect their pain diary, pill count, adverse events, and to determine if their~     stone has passed. Study participation ends after this follow-up visit.~   "
52519|NCT02369731|"~     This study is being performed as a post-approval safety study (PASS), per the~     Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA),~     to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in~     routine clinical practice.~   "
52520|NCT02369718|"~     Cochlear implant microphones are subject to aging and dirtying. The evolution may affect~     their efficiency. Several signal coding strategies are used in cochlear implants and their~     behaviour may be more or less affected by the aging process. In this work the investigators~     wish to assess this phenomenon.~   "
52521|NCT02369705|"~     Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional~     full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a~     synchronized manner.~      The PSG data will be scored manually by a trained polysomnographic scorer, according to~     standard criteria for this clinical routine.~      The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep~     stages, snoring (optional) and body position (optional), in addition to parameters specific~     to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT)~     and will be compared to the PSG's manual scoring which serves as a Gold Standard.~   "
52522|NCT02369692|"~     The purpose of this prospective study is to gather procedural use and safety data on the~     initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr and~     Vascular Accessories 6 Fr.~      This study will focus on, but not be limited to, endovascular embolization procedures in the~     peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine~     arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial~     chemoembolization (TACE).~      The data will be analyzed for medical education, societal presentation and/or publication by~     the investigator.~   "
52523|NCT02369679|"~     Treatment of lymphedema is based on a combined program called complex decongestive therapy.~     The components of the complex decongestive therapy are skin care, kinesiotherapy, manual~     lymphatic drainage and compression. The compression with multilayer bandage has proved to be~     the most effective of these therapies when analyzed separately.The multilayer bandage~     produces a gradient compression on the limb where distal pressure is higher than proximal~     pressure. Several materials are needed for the multilayer bandage, including tubular bandage~     lining, digit bandages, foam under-cast padding and multiple layers of short-stretch~     bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient~     through a Velcro system.~      The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid)~     with the multilayer compression bandages in the treatment of the upper limb lymphedema.~   "
52524|NCT02369666|"~     The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code~     40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by~     endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress~     during 24 hours recovery from a 2-h running bout.~   "
52525|NCT02369653|"~     The purpose of this study is to compare the effect of a blood thinning drug called Apixaban~     versus no administration of a blood thinning drug, in preventing blood clots in children~     with leukemia or lymphoma. Patients must be receiving chemotherapy; including Pegylated~     L-Asparaginase and have a central line (a catheter inserted for administration of~     medications and blood sampling).~   "
52526|NCT02369640|"~     During the past decades, simulation-based training has become essential for making trainees~     fit for clinical practice. Traditionally, trainees are instructed to practice with as few~     errors as possible during simulation-based training. However, recent evidence from the field~     of psychology suggests that transfer of learning may improve if trainees are encouraged to~     commit errors during training. The aim of this study is to assess on performances with real~     patients the effect of error-management instructions compared to error-avoidance~     instructions during simulation-based virtual reality ultrasound training.~      This study is planned as a randomized controlled trial. Participants include medical~     students with no prior simulation practice at the fifth or sixth year of medical school. All~     participants receive 3 hours simulation-based ultrasound training focusing on fetal weight~     estimation. The participants (N=60) are randomized into two groups: Participants in group 1~     are instructed to follow the simulator program step-by-step to achieve the highest possible~     simulator metric scores by making as few errors as possible. Participants in group 2 are~     instructed to experiment and explore and to deliberately make errors during training. A~     simulation-based pre- and post-test is administered before and after training.~      Participants are scheduled to perform a transfer test seven to ten days after simulation~     training. The transfer test consists of fetal weight estimation on a real patient. The~     primary outcome is weight deviation of participant measurements compared to expert findings.~     Secondary outcomes include performance assessments of pre-, post- and transfer test~     performances by blinded ultrasound experts using the Objective Structured Assessment of~     Ultrasound Skills (OSAUS) scale. Using an alpha level of 0.05, an effect size of 0.80, and a~     power of 0.80, 25 participants are needed in the two study groups. Loss to follow-up of up~     to 20% of study participants is anticipated, resulting in 30 participants in each study~     group.~   "
67294|NCT02176512|"~     Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose~     combination in comparison to the single unit formulations~   "
52527|NCT02369627|"~     The purpose of this study is to evaluate a new approach to increase HIV testing among young~     adult Black, Hispanic, and white men-who-have-sex-with-men (MSM). In this randomized,~     controlled trial, participants will be assigned to one of three HIV testing groups: (1)~     rapid HIV self-testing group (OraQuick® In-home HIV Test), (2) conventional home-based HIV~     testing group (Home Access Express), and (3) community/medical-based HIV testing group. Upon~     completion of testing, participants will receive a questionnaire to evaluate their HIV~     testing experience, and also inquire about recommendations for future testing. Study~     participants will also have the option to refer other study eligible males to the study via~     email.~   "
52528|NCT02369614|"~     This is a randomized placebo/sham controlled, double-blind study investigating the efficacy~     of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham~     rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.~   "
52529|NCT02369601|"~     Premature rupture of membranes refers to the rupture of the fetal membranes prior to the~     onset of labor. Premature rupture of membranes is associated with a number of neonatal and~     maternal complications including an increased incidence of perinatal mortality and~     intra-amniotic infection. There is a need for improved diagnostic testing because of~     limitations of the current methods.~      PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding~     protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.~   "
52530|NCT02369588|"~     This study tests the effect of serving larger portions of all foods in a meal on the outcome~     of food and energy intake. Using a crossover design, participants are served the meal once a~     week for four weeks and the portion sizes are varied at each meal. Some of the foods served~     at the meal are low in calorie density (calories per gram) and some are higher in calorie~     density. The aim is to determine whether intake in response to larger portions differs~     depending on characteristics of the subjects or of the foods.~   "
52531|NCT02369575|"~     The purpose of this study is to investigate new therapies for advanced lung disease.~   "
52532|NCT02369562|"~     The purpose of this retrospective study is to investigate and identify factors associated~     with the failure of dental implants within the population rehabilitated with dental implants~     at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).~   "
52533|NCT02369549|"~     An investigator initiated pilot trial: two arm, double blind, placebo controlled,~     randomized, parallel group of approximately 750 patients with chronic kidney disease, and~     who have evidence of overt proteinuria, will be treated with micro-particle curcumin versus~     placebo over 24 weeks from start of the investigational medication date (approximately 6~     months) to test whether curcumin can slow chronic kidney disease progression in patients.~     Three 30 mg capsules of micro-particle curcumin will be self-administered once daily in the~     morning to determine the the safety and efficacy of curcumin relative to placebo in reducing~     albuminuria, reducing urinary interleukin-18 and slowing the loss of eGFR.~   "
52534|NCT02369536|"~     The objective of this study is to provide clinical data to support the effectiveness of a~     mixture of ingredients of natural origin, suitably selected and packaged, in the protection~     from liver damage, in subjects with NAFLD.~      Study design: double-blind, randomized, multicentre trial, placebo-controlled on two~     parallel groups.~      The study participants are healthy volunteers, since they do not have nor had any~     liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for~     at least one of the liver parameters -aspartate aminotransferase AST, alanine~     aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic~     abnormalities of steatosic liver) tests altered as compared to normal ranges.~      Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and~     at the end of treatment - 3 months).~   "
52535|NCT02369523|"~     The investigators plan to evaluate the length of time to discharge readiness between the~     groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs.~     periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In~     addition, the investigators will compare quadriceps strength recovery over time and~     exploratory variables between the groups.~   "
52536|NCT02369510|"~     The purpose of this study is to investigate whether the addition of a medication called~     epinephrine to spinal medications prolongs the duration of the anesthesia. The medication~     standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain~     medication (morphine). These medications typically last about 2 hours. The investigators~     want to determine if adding epinephrine to the spinal medications prolongs the anesthetic~     without side effects. A longer duration of anesthesia may be useful in prolonged repeat~     cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but~     the investigators want to specifically study combining it with the medications the~     investigators use regularly for cesarean section.~      You may qualify to take part in this research study because you are having a repeat cesarean~     section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want~     to determine if epinephrine will prolong the anesthetic.~   "
52537|NCT02369497|"~     This is a prospective study on the Ascension HRA device to collect data to assess the safety~     and effectiveness of the HRA.~   "
52538|NCT02369484|"~     The purpose of this study is to investigate the control of disease in pretreated patients~     with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well~     as the safety and tolerability (how severe the side effects are) of the treatment with~     afatinib.~   "
52539|NCT02369471|"~     To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo,~     in the presence of other antiepileptic drugs (AEDs).~   "
52540|NCT02369458|"~     No agent is known to have efficacy in patients with incurable HNSCC that progressed with~     prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this~     trial. Based on the preclinical and clinical data presented, the investigators propose that~     mitomycin C will have anti-tumor activity in these patients.~   "
52555|NCT02369263|"~     Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the~     Emergency Department (ED) employing the two point compression method. This study endeavors~     to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT)~     in the ED by EM Residents by comparing the results of that exam against the gold standard of~     a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.~   "
52541|NCT02369445|"~     The purpose of this pilot study is to compare an innovative toilet training strategy with a~     standard behavioral intervention in children with autism spectrum disorder (ASD), as~     implemented by teachers in the school setting. Thirty classrooms with a total of 60 children~     with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly~     assigned to either the innovative strategy group or the standard behavioral group. The~     innovative strategy employs an electronic moisture pager that sends a signal when the child~     begins having a urine accident. Outcome measures include rate of urine accidents and rate of~     toilet use in the two groups.~   "
52542|NCT02369432|"~     This proof of concept study aims to assess in patients suffering from atopic dermatitis if~     polymeric microparticles reach the pilosebaceous follicles of inflamed skin.~   "
52543|NCT02369419|"~     Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms~     and outcome of patients with congestive heart failure (HF), and depressed left ventricular~     ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %.~     Yet, the impact of frailty on the response to CRT has not been studied, until now.~      Purpose : To assess the impact of frailty in the elderly, on the response to CRT.~   "
52544|NCT02369406|"~     The overall objective of this study is to determine whether very early antiretroviral~     treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs~     and maintains immune responses, potentially allowing future periods off ART.~   "
52545|NCT02369393|"~     To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical~     Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with~     depressive symptomatology with a wait list control group (WL) in Spanish population.~   "
52546|NCT02369380|"~     Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration~     of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal~     filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel~     shoes~   "
52547|NCT02369367|"~     The goal of this clinical research study is to find the highest tolerable dose of~     lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination~     can help control malignant gliomas.~      Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic~     MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to~     learn the effect of lenalidomide on tumor tissue in patients who need surgery for the~     disease.~      This record represents the Phase II portion of original Phase I/II study (see registration~     record NCT00671801).~   "
52548|NCT02369354|"~     Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of~     education, behavior, and financial support interventions to improve consideration of live~     kidney transplantation/live kidney donation among African Americans on the deceased kidney~     waiting list. We hypothesize that interventions to help potential kidney transplant~     recipients and their potential donors overcome barriers to live donor kidney transplant~     (including family discussions, financial, or logistical barriers) could improve potential~     recipients' receipt of live kidney transplants.The main outcomes of TALKS will include~     whether potential recipients (1) have potential live donors call into the transplant center~     on their behalves; (2) have potential donors evaluated for transplant; or (3) receive a live~     donor kidney transplant.~   "
52549|NCT02369341|"~     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'~     Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in~     adults (18 to 60 years of age) and in the elderly (over 60 years of age).~   "
52550|NCT02369328|"~     Stroke is the second most frequent causes of mortality in the word after cardiovascular~     disease and the most frequent cause of disability. The majority of strokes are ischemic~     (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not~     exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long~     term functional recovery is largely dependent from the ability of the brain to reorganize.~     Conventional magnetic resonance imaging represents the most sensitive tool to diagnose~     stroke at the acute phase. However, up to now, no imaging tool is available to determine the~     time of stroke onset. Moreover, no imaging tool is available to precisely quantify the~     functional and structural plasticity mechanisms occurring after stroke. The main objective~     of the present study is to test the accuracy of sodium MRI to determine the time of stroke~     onset. The secondary objectives of the study are to determine the ability of~     non-conventional MRI techniques to quantify the degree of tissue damage and brain~     reorganization after stroke. Thirty patients will be included during the first 24 hours~     after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state~     functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on~     at the inclusion, after 24 hours, at 3 months and at 12 months.~   "
52551|NCT02369315|"~     This study evaluates Venezuela's National System of Child and Youth Orchestras, better known~     as El Sistema.~   "
52552|NCT02369302|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between DWC20141 and DWC20142 in healthy adult subjects.~   "
52553|NCT02369289|"~     A vegan diet is more and more prevalent in the general population in Israel in recent years.~     There have been some concerens that a vegan diet may lack in bone-health related nutrients~     (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral~     density. The study aims to compare bome mineral density and other biochemical bone health~     parameters in vegan and omnivore non-menopausal Israely females.~   "
52554|NCT02369276|"~     The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder~     girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula~     and duration after SND. The aims of this study are: 1. To assess the functional disabilities~     of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft~     tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This~     study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC~     post SND within 3months, >3- 6months,> 6months -1 year, more than 1 year as four different~     groups, 20 patient in each group.~   "
52578|NCT02368951|"~     To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and~     pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with~     advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)~   "
52556|NCT02369250|"~     Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic~     statin, that stimulate bone formation in critical-size cortical bone defects adjacent to~     titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a~     platelet concentrate with sustained release of various growth factors, having regenerative~     potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material~     has clinically satisfactory response, when used to fill periodontal intrabony defects. This~     double-masked randomized study is designed to evaluate the potency of combination of RSV~     1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical~     treatment of mandibular degree II furcation defects when compared with autologous PRF and HA~     bone graft placed after open flap debridement (OFD).~   "
52557|NCT02369237|"~     Anemia and inflammation are very common in patients with renal diseases. The most common~     procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect®~     is a portable device for non-invasive hemoglobin determination that works with a sensor that~     is applicable in infants and adults alike.~      The objective of this trial is to collect spectra with the non-invasive Haemospect® device~     in children of different age groups with renal failure and different hemoglobin~     concentrations. In parallel, corresponding hemoglobin values shall be obtained invasively to~     form the basis for the development of an algorithm for the device.~      To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are~     measured non-invasively with the Haemospect®. Various blood parameters for iron and~     inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron,~     white blood cell count and CRP.~   "
52558|NCT02369224|"~     A Cross- Sectional study; To assess the intra-rater and inter-rater reliability of a~     hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with~     multiple sclerosis~   "
52559|NCT02369211|"~     To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its~     potential to improve hospital efficiency and patient outcomes. The investigators compare the~     addition of IV acetaminophen versus placebo on postoperative PACU recovery times, inpatient~     hospital length of stay (LOS), patient satisfaction scores, postoperative pain scores,~     consumption of opiates as rescue agents and side effects, and costs associated with~     postoperative medications among patients undergoing robotic-assisted laparoscopic~     prostatectomy (RALP).~   "
52560|NCT02369198|"~     The first testing of TargomiRs in the human setting: dose-finding studies in patients with~     recurrent malignant pleural mesothelioma and non-small cell lung cancer~   "
52561|NCT02369172|"~     CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo~     the effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of~     this trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe~     substrate bupropion.~   "
52562|NCT02369159|"~     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of~     IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of~     pediatric subjects with acute uncomplicated influenza. Two thirds of the participants will~     receive peramivir, while one third will receive oseltamivir.~   "
52563|NCT02369146|"~     The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of~     two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected~     adults with virological suppression.~   "
52564|NCT02369133|"~     The investigators designed a prospective randomized study to investigate the efficacy of~     intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction,~     total morfin consumption and the incidence of morfin‑related side effects in patients~     undergoing cesarean section.~   "
52565|NCT02369120|"~     Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about~     the origin and meaning of pain for developing a biopsychosocial web-based educational~     intervention. The other aim of this project is to assess the effectiveness of this web-based~     educational intervention for chronic low back pain patients on pain cognitions, pain~     intensity, and disability.~      Methods: Mixed methods design, combining both qualitative and quantitative methodologies.~     For the qualitative part of this study, the investigators will use qualitative in-depth~     semi-structured interviews. For the quantitative phase we will use an experimental study~     design.~      Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care~     setting in the city of Lleida.~      Expected outcomes: The investigators expect to change and modify chronic low back pain~     patients´ cognition by using our web-site educational intervention, with the further outcome~     of reducing pain and disability.~   "
52566|NCT02369107|"~     Nausea and vomiting are the most common symptoms experienced by cancer patients after~     chemotherapy. Some patients have to endure such unpleasant symptoms even after using of~     antiemetic or anti-vomiting medications.The purpose of this study is to assess the~     therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting~     on patients with malignancy~   "
52567|NCT02369094|"~     Acupressure has been used for thousands of years in China. Through applying pressure on the~     specific acupoints based on TCM theory, acupressure could promote relaxation and wellness,~     balance yin-yang and treat diseases.~      The PI has been using acupressure to treat various diseases in the clinics of the School of~     Chinese Medicine, HKU. Acupressure has demonstrated significant efficacy in treating~     geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various~     painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also~     help to improve insomnia, reduce pain, and regulate the mood of the patients.~      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of~     frailty increases with age. As our life expectancy increase, there will be more elderly~     suffered from frailty in the later stage of their life. Although there is still a lack of~     universally accepted clinical definition for frailty, the syndrome is now commonly~     understood as decreased reserves in multiple systems, and lowered resilience to negative~     stress. Frailty could be initiated by single or multiple conditions including malnutrition,~     chronic diseases, lack of exercise, stress and physiological or social changes caused by~     aging. Its manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional~     neuroendocrine system and a pro-inflammatory state. Frailty could affect the emotional state~     of the elderly, meanwhile, positive affect is protective against the functional and physical~     decline associated with frailty.[1] There is limited treatment or medication for frailty.~     The investigators believe that acupressure could be a possible non invasive means to improve~     the general health conditions, including the emotional conditions of the frail elderly. In~     the past 2 years, the school of Chinese Medicine has been promoting acupressure as a health~     maintenance technique to the elderly, mostly frail elderly living in the community dwelling~     through seminars. It is in our interest to run a prospective research to further understand~     the efficacy of acupressure in a wider range of frail elderly. The investigators would like~     to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if~     acupressure could help the frail elderly to improve their general quality of life.~   "
75863|NCT02064322|"~     The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for~     fusion and pain reduction of the SI joint.~   "
52568|NCT02369081|"~     This study was recommended by NICE, as part of its 2006 guidance for the treatment of~     hypertension, and is urgently required to provide evidence for the treatment recommendations~     in patients with resistant hypertension. The study will be a randomised placebo-controlled~     double-blind crossover comparison of an α-blocker (α), β-blocker (β), and K+-sparing~     diuretic (∆).~      Patients will have a BP at entry above target on ABPM or home monitoring despite supervised~     administration of maximum tolerated doses of A+C+D. Over 48 weeks they will then receive, in~     random order either placebo or two doses each of doxazosin (α), bisoprolol (β) or~     spironolactone (∆). Each treatment cycle will last 12 weeks, with a forced dose-doubling at~     6 weeks.~      The time course for the study will be similar to study one. 340 patients will provide 90%~     power, at α=0.01 to detect a 3 mmHg overall difference in home sBP between any one drug and~     placebo, with spironolactone hypothesized to be best overall. The study will be able to~     detect a 6 mmHg difference in sBP between each subject's best and second-best drug predicted~     by tertile of plasma renin, justifying routine use of the measurement in patients with~     resistant hypertension.~   "
52569|NCT02369068|"~     The goal of this study is to compare the effectiveness of two different medications used in~     intravaginal trigger point injections (injections into extremely painful areas of a muscle)~     to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug~     prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a~     synthetic corticosteroid used as an anti-inflammatory agent).~   "
52570|NCT02369055|"~     The aim of this study is to analyze and describe rehabilitation pathways of stroke patients~     in northern Norway and Denmark in relation to how patients describe their health-related~     quality of life one year post stroke.~      The study will consist of 1) Translate, cross-cultural adapt and validate a questionnaire 2)~     Describe the level of quality of life and rehabilitation pathway in the two countries 3)~     In-depth interviews of a smaller group of patients for a more complex understanding~      The study is part of a larger prospective observational multicenter-study of two patient~     cohorts with stroke.~   "
52571|NCT02369042|"~     External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory~     rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies~     while tracking clinical changes in acute in-hospital and chronic outpatient heart failure~     patients.~   "
52572|NCT02369029|"~     This is the first study where BAY1238097 is given to humans. Impact of the study is to~     evaluate if patients with advanced cancer show clinical benefit under the treatment with~     BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all~     comers) and lymphoma will receive the study drug treatment in an escalation scheme (no~     placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of~     BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be~     determined~      After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung~     cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be~     enrolled A separate escalation scheme will be applied to patients with leucemias, and at the~     maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.~      the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic~     parameters of BAY1238097 and tumor response to the treatment.~      BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the~     tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the~     patient decides to withdraw from the treatment.~   "
52573|NCT02369016|"~     Assess the efficacy and safety of copanlisib monotherapy~   "
52574|NCT02369003|"~     This pilot study is designed to follow up on a previous, preliminary study and test the~     long-term safety and feasibility of the implantation of autologous peripheral nerve grafts~     into the substantia nigra pars compacta (SNpc) or the basal nucleus of Meynert (NBM) in the~     basal forebrain of participants with PD undergoing deep brain stimulation (DBS) surgery.~     Peripheral nerve tissue contains Schwann cells which produce growth factors that have been~     demonstrated to support the survival and function of neurons.~      Participants will serve as their own donor for the tissue, which will be implanted at the~     time they undergo DBS surgery.~   "
52575|NCT02368990|"~     The aim of the study is to collect real world information on patients with locally advanced~     or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment~     with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and~     have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin~     /Carboplatin).~   "
52576|NCT02368977|"~     This study will evaluate the feasibility of using the Third Eye Panoramic device in~     conjunction with standard colonoscopes in a clinical setting.~      Patients will undergo a colonoscopy procedure during which the study device will provide~     video imaging of areas of the colon that are difficult to evaluate with the colonoscope~     alone.~      The utility of the device will be assessed from the impressions of the investigators and~     from telephone follow-up with subjects to assess for post-procedural complications.~   "
52577|NCT02368964|"~     In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the~     end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing~     hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually~     given between 12-24 hours before the hCG triggering dose.One protocol used at the~     investigators unit, after a cycle with low proportion of mature oocytes per number oocytes~     retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.~      Lately, new researches showed that dual triggering of final oocyte maturation with a~     combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders~     undergoing the GnRH-antagonist COH protocol~      Another treatment option is high dose hCG. Only few case reports have described the use of~     high dose hCG after aspiration of non mature oocytes at a previous cycle. At the~     investigators IVF unit, patients with previous history of high percentage of immature~     oocytes retrieved, are triggered at the following cycle, either with double trigger or with~     high dose of hCG decided by the physician consulting the patient. It is still not known with~     which way of triggering more mature oocytes is retrieved.~      The aim of this study is to perform a prospective randomized controlled study in patients~     with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved,~     despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles~     triggered with high dose hCG to those triggered with hCG+GnRH agonist.~   "
52580|NCT02368925|"~     Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to~     improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck~     scale score and Global Aesthetic Improvement Scale scores will be assessed at study~     follow-up visits.~   "
52581|NCT02368912|"~     This study consists of four parts:~      Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in~     healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and~     effect on certain hormones and if possible to determine the highest well-tolerated dose of~     ASP1707 in healthy young male subjects under fasted conditions.~      Part 2 is an open label, randomized crossover, single dose study to determine the effect of~     food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male~     subjects.~      Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to~     evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly~     men and healthy premenopausal females, and to determine the effect on certain hormones in~     males. Age and gender is also evaluated.~      Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to~     evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in~     healthy pre-menopausal female subjects.~   "
52582|NCT02368899|"~     This project expands upon the proof-of-concept work done under the pilot project in order to~     get Interventionaire© poised for more widespread use. Interventionaire© is designed to~     deploy a computerized interactive questionnaire to patients in a physician waiting room. The~     information gathered is intended to be a conversation starter for primary care providers and~     patients (who may feel more at ease with the computer in revealing health risk behaviors,~     like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost~     savings by delivering a wide reaching and highly acceptable prevention strategy for~     integrating risky health behavior screening and brief intervention into mainstream medical~     practice.The investigators overall hypothesis is that participants receiving the~     computerized intervention will have greater improvement than those receiving the attention~     control condition.~   "
52583|NCT02368886|"~     This randomized phase II trial studies how well lower-dose compared to standard dose~     regorafenib works in treating patients with colorectal cancer that has spread from the~     primary site (place where it started) to other places in the body and does not respond to~     treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of~     new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for~     cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more~     effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid~     cream that is commonly used to treat a variety of skin conditions and may help prevent~     hand-foot skin reactions in patients receiving regorafenib.~   "
52584|NCT02368873|"~     Study is a prospective, multicenter, randomized trial evaluating whether prophylactic~     laparoscopic placement of a dual-component IPOM mesh around a colostomy may prevent~     parastomal hernia compared with conventional colostomy after abdominoperineal resection.~     Eligible subjects will be recruited prospectively from five Finnish Hospitals (Oulu~     University Hospital,Vaasa Central Hospital, Helsinki University Hospital, Lahti Central~     Hospital, Jyväskylä Central Hospital). Patients were considered eligible for this study if~     undergoing laparoscopic abdominoperineal resection for rectal adenocarcinoma. Patients are~     randomized to prophylactic preperitoneal placement of a dual-component mesh (Dynamesh IPOM)~     around permanent colostomy or to conventional permanent colostomy. Estimating a parastomal~     hernia rate of 50%, a sample size of 26 patients per each study group is projected to~     provide 90% power (1-beta) with a alpha 0.05 (2-beta) to detect a 40% reduction in risk for~     parastomal hernia at 1-year. Since we expect a dropout rate of 20%, 37 patients per study~     group will be included in this study.~      All abdominoperineal resections are performed using laparosopic technique. At the and of the~     abdominal laparoscopic phase the straight permanent end colostomy is performed. In the~     intervention group the 10 x 10 cm Dynamesh IPOM mesh is cut in the middle according to~     volume of the bowel. Stapled bowel end is then pulled through the crosswise opened mesh,~     which is pushed to the abdomen and fixed to the peritoneum.~      Follow-up visits are scheduled at 1-, 3- and 12-month after surgery. Patients are evaluated~     for their clinical status and C-reactive protein, leukocytes and hemoglobin are assessed at~     each control visit. Computed tomography (CT) scan with and without Valsalva maneuver is~     performed 12 months after surgery for radiological evaluation of possible parastomal hernia.~      The primary end-point of this study is the incidence of clinically and radiologically~     detected parastomal hernias, and their extent 12 months after surgery. The secondary outcome~     end-points were colostomy-related morbidity such as stomal stenosis, necrosis and/or wound~     infection.The extent of parastomal hernia was graded at CT according to the Hernia Society~     criteria.~      Statistical analysis is performed using a SPSS statistical software. Continuous variables~     are reported as the mean and standard deviation, whereas nominal variables are reported as~     counts and proportions. Univariate analysis is performed with the Mann-Whitney U test and~     Fisher's exact test. P-values < 0.05 are considered statistically significant.~   "
52585|NCT02368860|"~     This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI~     regimen [oxaliplatin (O), xeloda (X) and irinotecan (I)] and to evaluate for preliminary~     evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma.~     The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype~     directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda)~     administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid,~     fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.~   "
52586|NCT02368847|"~     Urinary tract infections are one of the most common types of infections in older persons.~     The general aim of this study is to improve the epidemiological knowledge and develop a~     better diagnostic algorithm for urinary tract infections in older institutionalized~     individuals in order to reduce excessive prescribing of antibiotics and prevent~     antimicrobial resistance.~   "
52587|NCT02368834|"~     This study designed and evaluated a psychoeducation program for parents of ADHD children in~     terms of improving medication adherence and clinical benefits.~   "
52588|NCT02368821|"~     A deeper understanding of the syncytiotrophoblast development processes and its properties~     may allow a better understanding of the placenta pathological process for the development of~     treatment models for the relevant pregnancy complications.The aim of this study is to~     compare telomere length, aggregate formation, and senescence markers in placentas from~     complicated pregnancy with placentas from normal pregnancy.~   "
52602|NCT02368639|"~     This study will use a modified version of a positive airway pressure device to supply air to~     the participant, while undergoing supervised polysomnography. Positive airway pressures are~     typically applied to many patients with hypoventilation, in this study these pressures will~     be titrated by a qualified sleep technician. During the night these pressures will be~     altered to optimise comfort.~   "
52786|NCT02366208|"~     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1~     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from~     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with~     chronic hepatitis B.~   "
52589|NCT02368808|"~     Coping with Loss is a randomized controlled trial to assess the effectiveness of a~     bereavement intervention targeting female adolescents who have experienced the death of~     someone important in their lives. Adolescents aged 12 and older in the Free State province~     of South Africa will be invited to participate in an 8-session school-based peer support~     group focused on coping with loss. Interventions will be implemented by Social Workers from~     Child Welfare Bloemfontein and Childline Free State (CWBFN & CLFS) that have provided~     support services for orphans and vulnerable children (OVC) in the Free State Province since~     2013. The study population will be identified through the CWBFN & CLFS intake process and~     consist of bereaved female adolescents from up to 11 participating schools. Eligible~     adolescents will be randomly assigned to receive the intervention in 2015 or wait-listed for~     enrollment following the study period. Survey data will be collected from adolescents and~     caregivers before and two months following the completion of the interventions. Data will be~     analyzed to assess for pre- and post-test differences between the intervention and~     wait-listed group on key psychosocial outcomes, including measures of grief, resilience,~     mental health, social support, academic competence and adolescent-caregiver interactions.~   "
52590|NCT02368795|"~     Pancreatitis is the most important complication of ERCP. The severity of this condition~     varies from mild to severe and can lead to prolonged hospitalization, surgical~     interventions, and even death. Several patient-related and procedure related factors have~     been identified that are associated with a higher risk of post-ERCP pancreatitis. So far,~     several methods have been proposed to avoid pancreatitis in patients at higher risk of this~     complication.~      Several studies have shown that different drug therapies (indomethacin suppository, a~     sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may~     reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and~     easy to administer.~      Several other studies have shown that pancreatic duct stenting (placement of a plastic tube~     in the pancreatic duct) is an effective intervention in preventing and reducing the severity~     of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few~     drawbacks to consider with pancreatic duct stenting: there are some difficulties with~     insertion of a PD stent, it is associated with a need for radiological follow-up and/or~     repeat endoscopy for removal, higher cost and a small but important risk of complications~     (e.g. stent migration).~      Most of the clinical trials of pancreatic duct stenting were performed, before the results~     of trials of drug therapies were available. Moreover, no RCT (to the investigators~     knowledge) has compared the efficacy of pancreatic duct stenting in patients who already~     received a combination of drug therapies to prevent post-ERCP pancreatitis in high-risk~     patients. The purpose of this study is to determine the noninferiority of a combination of~     drug therapies in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in~     high-risk patients.~   "
52591|NCT02368782|"~     Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods~     which are widely used to determine the presence of hearing in audiology clinics. Under some~     circumstances and children, the study should be applied under general anaesthesia. The aim~     of this study was to find out the influence of propofol (P) and ketamine (K) on OAE~     measurements. .~      Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be~     included in this study after Institutional ethics committee approval and informed consent of~     parents. Children will be evaluated one day before surgery by tympanometry. Psychologically~     prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture~     of Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive~     blood pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and~     distortion product otoacoustic emissions (DPOAEs) will measured in both ears of each patient~     (n=20 ears) prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg~     or ketamine 2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five~     minutes later TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this~     measurement the routine general anaesthesia and surgical protocol will be commenced. Heart~     rate, blood pressures TEOAE and DPOAE measurements will be compared at pre and post stages~     by paired Student's t- test.~   "
52592|NCT02368769|"~     The purpose of the study is to assess whether performing a frozen section diagnosis off site~     with virtual slides would be as quick and accurate as usual technique.~   "
52593|NCT02368756|"~     The Endurance 2 Trial is to determine the need for ongoing intravitreal aflibercept~     injections for patients with diabetic macular edema who have previously completed the VISTA~     study.~   "
52594|NCT02368743|"~     This national, observational and multicentre study aims at establishing a picture of real~     clinical practices management among patients treated with Pentasa®, according to the current~     therapeutic strategy in ulcerative proctitis. This study should be able to provide data on~     patients' health related quality of life, compliance and efficacy in real clinical practice.~   "
52595|NCT02368730|"~     In this non-interventional multicentre, prospective, observational cohort study, the~     efficacy of desmopressin is evaluated in patients with platelet dysfunction due to~     acetylsalicylic acid or cox-1-inhibitors within the context of surgical procedures.~   "
52596|NCT02368717|"~     The purpose of this study is to investigate the efficacy and safety of 4-week double-blind~     treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to~     moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label~     extension phase with PENTASA enema and/or PENTASA tablets.~   "
52597|NCT02368704|"~     The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress~     pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic~     patients compared to healthy subjects normoglycemic matched for age and sex an to~     investigate whether ER stress pathway can be activated in response to insulin. Indeed, some~     preliminar on rates studies shows that ER stress pathway is activated by insulin in liver~     and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.~      For this, we propose a case control study of type 2 diabetic patients vs control subjects in~     which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue~     obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue~     subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.~   "
52598|NCT02368691|"~     The purpose of this study is to determine if GTx-024 is effective and safe in the treatment~     of patients with advanced, androgen receptor positive triple negative breast cancer (AR+~     TNBC).~   "
52599|NCT02368678|"~     The objective of this study was to evaluate whether short-term full mouth disinfection~     protocol could have a greater reduction in the levels of halitosis and volatile sulfur~     compound or not, when compared to quadrant-wise scaling and root planing~   "
52600|NCT02368665|"~     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination~     therapy on patients of essential hypertension who are not properly controlled by amlodipine~     besylate monotherapy.~   "
52603|NCT02368626|"~     The need for cosmetic facial enhancement procedures with minimal down time and low risk has~     led to the development of methods for non-surgical skin rejuvenation. Various ablative~     lasers were developed, which remove the full skin surface in a controlled manner. However,~     the prolonged recovery and the significant risks prompted the development of fractional~     lasers which ablate the skin in a fractional manner, leaving untreated areas to improve~     healing process. In the past few years, fractional RF systems have been introduced that~     enable controlled skin resurfacing accompanied with dermal collagen remodeling. System using~     focused ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting~     effect.8 Similar to these devices the EndyMed Pro™ System with RF Micro-Needles handpiece~     (INTENSIF) enables fractional skin coagulation with dermal heating for the reduction of~     wrinkles together with a lifting effect.~   "
52604|NCT02368613|"~     The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of~     hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each~     groups are composed by 16, will be participated in this trial.~   "
52605|NCT02368600|"~     The number of women with gestational diabetes mellitus (GDM) had been increasing. Maternal~     GDM has a great impact on both the health of the mothers and the offspring. Antenatal~     lifestyle interventions, in particular dietary intervention appear to be feasible to improve~     maternal GDM and weight gain. To the best of our knowledge, there has been no such trial~     examining the feasibility of a lifestyle intervention in pregnant women in Hong Kong.~     Therefore, we plan to conduct a randomized controlled trial comparing a lifestyle~     modification program (LMP) in early pregnancy and the usual antenatal care in high risk~     Chinese pregnant women in Hong Kong. Intervention group subjects (n=110) will participate in~     a dietitian-led LMP including dietary and exercise component from the first antenatal (AN)~     booking to 24 weeks gestation. 110 women in the control group will receive routine hospital~     antenatal care. The primary endpoint will be the prevalence of GDM measured using a 75 g~     oral glucose tolerance test at 24-28 weeks gestation. The secondary endpoints will be the~     proportion of infant born with large for gestational age (>=95th percentile of the~     customized birth weight) and macrosomia (>=4 kg at birth). The intervention group involves~     dietary and exercise advice and monitoring. No drug or invasive procedure is involved. The~     control group will receive routine antenatal care and will be provided with an educational~     pamphlet on diet and exercise during pregnancy.~   "
52606|NCT02368587|"~     The purpose of this study is to investigate the safety and efficacy of intracoronary or~     intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC)~     in patients with ischemic cardiomyopathy secondary to myocardial infarction.~   "
52607|NCT02368574|"~     Based on the value-based medicine, a randomized clinical trial was conducted to compare the~     role of class II and class III hysterectomy in patients with low risk early staged cervical~     cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).~   "
52608|NCT02368561|"~     A pilot study of the effects of 3 retro-calcaneal hyalin G-F 20 injection on the clinical~     and radiological changes in 20 adult patients with changes in insertional achilles~     tendinopathy.~   "
52609|NCT02368548|"~     The study aims to assess the clinical and economic impact of a pharmaceutical care program~     initiated in the Emergency Department versus conventional follow-up of patients with~     decompensated heart failure/COPD.~   "
52610|NCT02368535|"~     The investigators wanted to determine if the establishment of interdisciplinary rounds has~     made meaningful changes in the perceptions of teamwork and communication.~      The purpose of this study is to determine if the establishment of interdisciplinary daily~     rounding has improved teamwork in an academic, tertiary care labor and delivery unit.~   "
52611|NCT02368522|"~     The study aims to collect information on the current treatment patterns for Hepatitis C in~     participating countries. There is also a focus on patients receiving a~     daclatasvir-containing treatment regimen who will be followed prospectively for 12 months~     after treatment initiation to collect real-world data on effectiveness and safety of the~     treatment. Additional analysis will differentiate between selected subpopulations.~   "
52612|NCT02368509|"~     The aim of the present study was to evaluate the impact of chemotherapy on sensorial~     perception in lung cancer patients in comparison to a control group (individuals without~     lung cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44~     patients and 44 controls will be tested for olfactory and gustatory abilities before and~     after treatment (for patients) and for two sessions separated by the same duration for~     controls. Primary measure outcome will be to examine the impact of treatment on the~     perception of hedonic valence of odors. Secondary measure outcome will include odor and~     taste perceptual changes and questionnaires on eating habits and behaviors, in order to~     examine the impact of treatment on odor, taste and food perception.~   "
52613|NCT02368496|"~     Recent progress in parenteral nutrition has contributed to improve vital prognosis and to~     reduce morbidity in patients with severe intestinal failure.~      Currently, home parenteral nutrition is the only alternative to prolonged hospitalization~     for those patients. However, long-term parenteral nutrition can result in complications~     especially in bone, such as osteopenia or osteomalacia, then increasing the risk of~     fractures. Children are especially at risk because of bone growth and peak mineralization~     acquisition during puberty.~      Moreover, frequency and risk factors of those complications are not well documented for~     children.~      Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone~     mineralization measurement. In pediatrics, this technique has some limits such as the~     underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the~     BMD in tall children, and the inability to distinguish cortical from trabecular bone or to~     evaluate the bone microarchitecture.~      HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive~     assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA.~     However this technique has never been validated in patients with long-term parenteral~     nutrition.~      During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in~     addition to the routine medical tests.~   "
52639|NCT02368158|"~     In this study predictors of fitness to drive a car in cardiologic patients after acute~     intervention and discharge from hospital to home or rehabilitation are determined in~     addition to possible automotive monitoring of vital signs via contact less sensors.~   "
52614|NCT02368483|"~     This is a single-group, prospective, intervention study. A total of 30 participants with~     unilateral symptomatic femoroacetabular impingement will be included into the study. The~     intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2~     times/week supervised training, 2 times/week home training). The training includes physical~     exercises routinely used worldwide in clinical settings. No control intervention group was~     included into the study because nowadays there is no standard conservative treatment for~     patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1)~     baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical,~     functional, neuromuscular and self-reported parameters will be collected during assessments.~   "
52615|NCT02368470|"~     New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a~     broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been~     successfully introduced into the treatment of Helicobacter pylori infection. However, it was~     suggested that resistance to fluoroquinolones has been increasing in the Korean population~     and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin~     (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily,~     oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against~     Gram-positive organisms, whilst retaining good activity against Gram-negative organisms.~     Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with~     activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times~     greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro~     activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and~     other members of the quinolone class. This potent activity is believed to be due to the~     enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in~     S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and~     M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M.~     pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.~   "
52616|NCT02368457|"~     Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic~     and irreversible complication after head and neck radiotherapy with no medical treatment to~     limit or reduce symptoms.~      Different clinical trials have shown a significant scientific evidence that the treatment~     with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the~     tissue fibrosis. This study proposes to use this drugs to determine if there is healing of~     mandibular osteoradionecrosis and/or a symptomatic improvement as well.~   "
52617|NCT02368444|"~     The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral~     therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms~     and sleep quality in people who have experienced a traumatic event and are reporting trauma~     symptoms.~   "
52618|NCT02368431|"~     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication~     zonisamide for the treatment of heavy drinking alcoholic Veterans.~   "
52619|NCT02368418|"~     China Rural Health Initiative (CRHI), a large-scale, factorial, cluster-randomized,~     controlled trial was conducted in 120 villages selected from 5 Northern Provinces of rural~     China between 2010 and 2012. Two interventions were evaluated through CRHI. One is the~     standard disease management program of individuals at high risk of cardiovascular disease~     delivered by Primary Care Providers (village doctors). Another one is a community-based Salt~     Reduction program delivered by community health educators. CRHI study interventions had~     ended for two years now and provide a good opportunity for us to understand whether its~     effects could be prolonged to a longer term. This study wants to evaluate the effects of~     CRHI interventions at 2 years after the end of CRHI (from Sep 2014 to Feb 2015).~      In this follow-up survey, the baseline cohort of 5050 and post-intervention cohort of 4887~     CRHI participants who were randomly selected from the 120 villages from 5 northern provinces~     of rural China will be recruited for the follow up study from Sep 2014 to Feb 2015. A~     questionnaire derived from CRHI baseline and post-intervention surveys will be used to~     collect data on disease history, medication use, care seeking patterns, lifestyle factors~     and so on. Weight, height, blood pressure and heart rate will be measured in the standard~     ways.~   "
52620|NCT02368405|"~     This is a randomized controlled trial to study a nutrition education intervention in~     individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and~     the community setting (n = 100). Participants in the treatment group will receive six~     interactive nutrition lectures based upon a successful program that has been used in older~     adults titled Eat Smart, Stay Well. The goals of intervention are to improve whole-grain,~     fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake.~     Secondary outcomes will include improvements in waist circumference of body mass index and~     some biomarkers such as cholesterol and blood sugar.~   "
52621|NCT02368392|"~     The aim of this study is to describe incidence of in-hospital deaths and outcomes after~     attempted cardiac arrest resuscitation, availability of resuscitation equipment and medical~     staff training in state Hospitals of Sri Lanka.~   "
52622|NCT02368379|"~     The purpose of this study is to determine presence of central adrenal insufficiency in~     children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to~     results of overnight metyrapone test.~   "
52623|NCT02368366|"~     Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a~     source of significant morbidity and family burden. Novel behavior problems are among the~     most common and problematic consequences, yet many youth fail to receive needed~     psychological services due to lack of identification and access. Linking youth with TBI to~     effective treatments could improve functional outcomes, reduce family burden, and increase~     treatment satisfaction. The investigators overarching aim is to compare the effectiveness,~     feasibility, and acceptability of three formats of family problem solving therapy (F-PST)~     for improving functional outcomes of complicated mild to severe adolescent TBI:~     therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST.~   "
52656|NCT02367937|"~     The aim of the study is to evaluate the effect of PRC-4016 at steady state on the~     pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a~     CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female~     subjects.~   "
52624|NCT02368353|"~     The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years~     during which the psychotic symptoms are present at a subliminal level in severity or in~     frequency. The clinical criteria mental status with risk (AR) identifies patients among~     whom 10 in 40 % will make a psychotic transition in the year.~      Our hypothesis is that interventions to reduce reactivity to stress are effective in~     reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms.~     Our project is to evaluate a therapy for stress management in at risk patients, compared to~     a conventional monitoring, and implement a longitudinal follow-up concerning the reduction~     of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these~     interventions offer an alternative to antipsychotics all the more interesting since they~     should also reduce the risk of depression and suicide.~   "
52625|NCT02368340|"~     Hermansky-Pudlak Syndrome (HPS) is a rare genetic disease that is associated with~     oculocutaneous albinism, bleeding, granulomatous colitis, and pulmonary fibrosis in some~     subtypes, including HPS-1, HPS-2, and HPS-4. Pulmonary fibrosis causes shortness of breath~     and progressive decline in lung function. In HPS patients with at-risk subtypes, almost all~     adults eventually develop fatal pulmonary fibrosis unless they undergo lung transplantation.~      The purpose of this study is to identify the earliest measurable pulmonary disease activity~     in individuals at-risk for HPS pulmonary fibrosis. The study also aims to develop biomarkers~     that will aid in understanding of the causes of HPS pulmonary fibrosis and facilitate more~     rapid conduct of therapeutic trials in HPS patients with mild pulmonary disease in the~     future.~   "
52626|NCT02368327|"~     This clinical study is part of the BIOVACSAFE project which is funded by the Innovative~     Medicine Initiative. In this study we will take a small muscle biopsy in order to identify~     any differences in the response around the actual site of injection compared with responses~     we measure in blood at the same time.~   "
52627|NCT02368314|"~     The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and~     Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.~   "
52628|NCT02368301|"~     The objective of this expanded access program is to provide treatment with elotuzumab in~     combination with lenalidomide and dexamethasone for patients with relapsed or refractory~     multiple myeloma at U.S. sites where licensed physicians determine clinical need.~   "
52629|NCT02368288|"~     The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients~     obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and~     HBsAg loss with sustained viral response after treatment. However this target could not be~     get if patients keep HBV DNA positive during interferon treatment and offend relapse after~     withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients~     with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies~     of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss~     after 48 weeks of combined therapy, compared with control group.~   "
52630|NCT02368275|"~     The objective of these cohorts is to detect potential genetic, neurophysiological~     psychological and cognitive risk factors for the development of chronic postsurgical pain~     including neuropathic pain.~   "
52631|NCT02368262|"~     This study evaluates (risk)factors influencing (in)continence in children with and without a~     brain injury.~   "
52632|NCT02368249|"~     The investigators aim to address whether terlipressin improves the renal outcome after liver~     surgery. Therefore the investigators are planning to conduct a double-blinded randomized~     control trial. The investigators will randomize patients undergoing any kind of liver~     surgery and being at increased moderate to high risk for post-operative acute renal failure~     into a control group receiving post- operative a placebo or into a group receiving~     post-operatively terlipressin in combination with human albumin.~   "
52633|NCT02368236|"~     This study will adapt and test a touch-screen computer program to evaluate cancer risk and~     provide patient-tailored recommendations for appropriate risk-based testing. This~     individually tailored intervention delivered right at the point of primary care and just~     prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.~      The primary aim of this project is to test whether a tailored intervention promoting~     risk-appropriate cancer testing results increases participation compared with a simple~     non-tailored reminder or no reminder. The trial is designed to determine the extent to which~     the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate~     colorectal cancer testing, as documented by electronic medical record audit; (2) patient~     receipt of risk-appropriate colorectal cancer testing recommendations from their physicians,~     as documented by electronic medical record audit; and (3) changes in patients' intent to~     participate in risk-appropriate colorectal cancer testing, as documented by patient report.~      The Family and Community Medicine and General Internal Medicine clinic databases will be~     used to identify potentially eligible patients with upcoming scheduled appointments. Because~     physicians will be the unit of random assignment, patients will be coded before study~     invitation as potential participants in the intervention or the comparison group. A random~     sample of eligible intervention and comparison group patients will be selected for contact.~     Identified patients will be mailed letters from the practices and signed by their physicians~     requesting their participation. The letters will describe a study of beliefs and practices~     about cancer prevention and early detection and will provide a toll-free number to refuse~     contact. One week after the mailing, patients who have not called to refuse contact will be~     called by study staff to explain the study, verify eligibility and, if the patient agrees,~     to arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These~     calls will be made by trained research assistants who will follow standard calling~     protocols. After consent, participants will complete the computerized data collection (CRIS)~     immediately prior to a scheduled primary-care appointment. Intervention group patients and~     their physicians will receive a printout recommending risk-appropriate colorectal testing~     and ways to overcome perceived barriers to testing. A member of the research team will hand~     the patient his or her printout and will deliver the other printout to the physician.~     Comparison group patients and physicians will receive non-tailored printouts that are simple~     reminders about testing.~      The investigators will also establish a true no-contact control by conducting a~     retrospective chart review for randomly selected patients who did not receive an invitation~     to participate in the study. This no-contact control will establish a baseline screening~     rate. The investigators will then conduct analysis with the comparison and intervention~     group to see if individuals who participate in CRIS have a higher screening rate for~     colorectal cancer compared to the non-contact group. These additional data will help us~     better assess study Aims 1 and 2.~   "
52634|NCT02368223|"~     The aim of the study is to determine the feasibility of the portable version of the~     YouGrabber® system in children with central motor disorders.~   "
52635|NCT02368210|"~     This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and~     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with~     plaque psoriasis.~   "
52636|NCT02368197|"~     This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon~     (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of~     hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas~     in hemodialysis patients.~   "
52637|NCT02368184|"~     The purpose of this study is to obtain observational data allowing for the preliminary~     assessment of the utility of a noninvasive physiologic monitor for monitoring of patients~     with congestive heart failure.~   "
52638|NCT02368171|"~     Research design: This is a controled prospective study.~      Methodology:~      Patients with newly diagnosed and untreated OSA with total apnea-hypopnea index (AHI) >5/h,~     and control (AHI<5/h) will be recruited from the Long Beach VA sleep center. Controls are~     subjects without OSA or other sleep disorders and no sign of pulmonary hypertension based on~     echo. The investigators also measure pulmonary artery pressure by 2D Echo and exclude~     patient with any sign of left heart dysfunction. PH will be defined as RVSP > 35 mmHg or~     mean PA pressure>25 mmHg. The investigators will recruit subjects with and without PH and~     OSA in three separate groups:~        1. group one : OSA+ PH,~        2. group two: normal individual with no OSA and no PH,~        3. group three: OSA with no PH Pulmonary function test will be done to exclude patients~          with underlying lung disease.~      The inclusion criteria is: Age >20, AHI >5, AHI <5 (as control), RVSP > 35 mmHg OR Mean PA~     pressure>25 mmHg, RVSP < 35 mmHg OR Mean PA pressure < 25 mmHg (as control).~      Subjects will be excluded if they had known peripheral vascular disease, liver disease,~     hemolytic anemia, inflammatory disease, active infection, or if they were pregnant, on~     therapy for OSA, on chronic steroid treatment, or younger than 20 years of age, patients~     with left heart failure (systolic or diastolic), patients are on PH medications including~     sildenafil, active smokers, COPD and asthma, active infection or inflammatory disease and~     collagen vascular disease.~      Nocturnal polysomnography will be performed and scored according to the American Academy of~     Sleep Medicine.~      Exhaled Carbon monoxide (CO) will be measured with a calibrated fuel cell type~     electrochemical device with sensor sensitivity of 1 ppm. The mean of three reproducible~     measurements will be recorded and corrected for ambient CO.~      Exhaled Nitric Oxide (NO) will be measured. At each testing session, at least three~     flow-regulated FENO measurements will be performed.~      The investigators will repeat 2D Echo and measurements of above factors after 3 months of~     CPAP treatment. The investigators also check patient's compliance with the treatment by~     downloading data off of their CPAP device.~      Each subject will be informed of the experimental procedures, which is approved by the Human~     Investigation Committee of the VA-Long Beach.~      Finding:~      The investigators hypothesize that HO pathway causing perturbation of pulmonary endothelial~     function by inhibition of nitric oxide.~      Clinical significance:~      OSA is associated with PH, but exact mechanism is not well known. In the past, I have shown~     that increased endogenous CO in the setting of elevated NO concentration is associated with~     endothelial dysfunction in patient with OSA. Therefore, the investigators sought to~     investigate the roles of HO and NO pathways in patients with OSA associated with PH.~      Impact/significance:~      It addresses a fundamental gap in our understanding of how OSA results in increase the~     pulmonary artery pressure and if substantiated, will provide the basis for the design and~     testing of new approaches to prevention and treatment of OSA.~   "
76908|NCT02050776|"~     The purpose of this study was to study the effect of stem cell therapy on the course of the~     disease in patients with Limb Girdle Muscular Dystrophy.~   "
52640|NCT02368145|"~     This study is being done to see if there is a relationship between stroke, post-stroke~     depression, and measures of inflammatory and/or stress compounds in the blood. Brain injury,~     as caused by stroke, leads to an inflammatory response in the brain which in turn can~     influence inflammatory and stress responses in other parts of the body outside of the brain.~     These responses can be measured by analyzing various substances in the blood and in the~     white blood cells. The investigators will measure these substances (cytokines,~     glucocorticoids) and compare them to the absence, presence, or degree of depression that the~     investigators will determine by neurological and psychological testing. The investigators~     will be drawing blood for this study on admission, at or around day 3, at or around day 7~     and at or around day 90, which is not part of routine stroke care. The investigators will be~     asking subjects to participate in answering question/scales on these same days, some of~     these questionnaires are also not part of routine stroke care. Standard stroke care is being~     done other than blood drawing/participating in answering questions/scales. Approximately 25~     people will be enrolled over one year.~   "
52641|NCT02368132|"~     The proposed study seeks to compare usual care and two different interventions for~     caregivers (CGs) of Veterans with dementia that are brief and administered by telephone. In~     the first intervention, care management (i.e., assistance from a nurse or social worker who~     works with the CG and Veteran's primary care providers), support, psychoeducation, and~     skills training are tailored to each individual CG and delivered on an individual basis. In~     the second intervention, care management is tailored and delivered to each individual CG,~     but support, psychoeducation, and skills training are delivered (also by phone) in a group~     format. This study will allow us to examine the added benefit of participating in a CG group~     that provides mutual peer support and feedback. The investigators also will evaluate the~     extent to which spousal vs. adult child CGs respond differently to the two interventions.~     Findings will help refine patient/CG-centered care management and support programs designed~     to facilitate access to services and improve the quality of life of Veterans with dementia~     and their families.~   "
52642|NCT02368119|"~     Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection.~      This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate~     vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers,~     age 18-65 years (mostly health care workers and other front line workers [e.g., individuals~     who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x~     10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.~      Heterologous booster dose allocation - Each participant will be offered the opportunity to~     be included in the booster step of this study. After obtaining consent and the additional~     review of pertinent medical history, participants in each group will be randomized to~     receive the candidate booster vaccine, MVA-EbolaZ or placebo.~      This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the~     first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial~     in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z~     vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity~     of the bivalent vaccine will be compared to clinical and immunologic responses documented in~     in parallel studies in East African subjects (Uganda) and North American subjects (NIH,~     Bethesda, MD, USA).~      Objectives:~        -  To see if an Ebola vaccine is safe and to study immune responses to it.~        -  To study the effect of the MVA-EbolaZ booster on the immune response~      Eligibility:~      - Healthy adults ages 18-65.~   "
52643|NCT02368106|"~     This study will create a patient data registry to collect and analyze information on~     technology usage and outcomes among patients receiving a broad range of relatively new~     radiation treatments that have become standards of care in our practice. Review of this~     information will serve as a basis for development of better patient management plans, to~     inform decisions about acquisition of new technologies, to provide information about quality~     in our care delivery, and to create a database that will securely warehouse ongoing~     information about what treatments the patients we serve need most and the challenges they~     face in the treatment process. The information gathered is likely to not only improve our~     services at the University of Maryland and its community sites but to advance medical~     science and enhance the quality of care for cancer patients.~   "
52644|NCT02368093|"~     Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan~     hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic~     drugs (DMARDs). Disease activity were assessed.~   "
52645|NCT02368080|"~     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults~     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each~     participants will perform the test (LCI) in duplicate on each device.~   "
52646|NCT02368067|"~     The purpose of this study is to compare the Instillation Technique Using The Modified Intra-~     Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes,~     Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma.~   "
52647|NCT02368054|"~     Cervical conization is done for pre-cancer disease. The procedure is performed with local~     anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and~     several different local anesthetics is being used including bupivacaine with and without~     adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by~     reducing absorption, but might affect cardiovascular function. This study will examine this~     effect.~   "
52657|NCT02367924|"~     Efficacy and safety of trabectedin in real-life practice, routinely used for the management~     of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to~     receive these drugs in Germany.~      Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma,~     after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.~     Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.~   "
52658|NCT02367911|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
52659|NCT02367898|"~     The purpose of this study is to measure the efficacy of an online cognitive training program~     against an active control condition in a large, randomized trial.~   "
52648|NCT02368041|"~     This is a single-center, non-randomized study.The study staff will use the InSpectraTM~     tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure~     baseline StO2 levels after applying the noninvasive probe to the thenar eminence. After a~     stable reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the~     obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded.~     After 3 minutes or once the StO2 level comes to zero (whichever is earlier), the cuff~     pressure will be released and the rate of reperfusion (Rres; % × sec-1) will be measured.~     The investigators hypothesize that heart failure in children causes a baseline lower thenar~     tissue oxygen saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate~     of reperfusion (Rres). The investigators also hypothesize that these changes will correlate~     with the severity of heart failure. The results of this study will provide groundwork for~     studies looking at correlation of therapy modification based on the combination thenar StO2~     and clinical presentation.~   "
52649|NCT02368028|"~     The fact that dental caries remains a major public health problem mandates that oral-health~     researchers explore new strategies for assessment of caries risk, as well as for caries~     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis~     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of~     caries research has been on identifying and characterizing acid-generating bacteria and the~     mechanisms of acid resistance. The purpose of this study is to investigate the type of~     bacteria that grows in the mouth and on teeth.~   "
52650|NCT02368015|"~     Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually~     asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea.~     Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate~     symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection,~     or following aspiration sclerotherapy, presents a severe complication of hepatic cystic~     disease requiring frequent hospitalization, long-term antibiotic treatment, and in some~     invasive therapies. Evidence that antibiotics are able to reach adequate intracystic~     concentration is however lacking. To prevent procedure-related cyst infection in patients~     receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In~     this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing~     serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to~     penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing~     the risk of developing cyst infection following aspiration sclerotherapy.~   "
52651|NCT02368002|"~     The purpose of this study is to learn how to personalize weight loss programs. In this~     research we will study:~        1. Whether a weight loss counselor should decide if the traditional weight loss therapy is~          working either after 3 or 7 weekly sessions of therapy and~        2. For those who haven't lost the expected amount of weight, whether it is more effective~          to add packaged meals to the traditional weight loss therapy or to change to an~          enhanced version of behavioral weight loss therapy.~   "
52652|NCT02367989|"~     Lifestyle modifications that include a diet high in fibre may lower the risk of developing~     type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in~     carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose~     response (PPGR). Among these, oat and barley derived β-glucan have received tremendous~     attention for their biological effects, including their ability to reduce PPGR in a wide~     variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase~     market demand for food grade barley, and help those who want to limit the rise in blood~     sugar after a meal choose products to meet their goals, but there are several gaps in the~     literature that need to be filled before a submission to Health Canada can be successful: 1)~     test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3)~     include a reference product that matches in total fibre, macronutrient, and energy profile;~     4) perform dose response. The proposed study design will address all of these gaps in the~     current literature and take into consideration Health Canada's guidance document for health~     claims related to the reduction in PPGR, which sets out the criteria by which the validity~     of such claims will be assessed.~      Hypothesis:~      Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.~      Specific objectives:~        1. To determine the minimum and most effective dose of barley β-glucan in quick bread on~          PPGR and insulin response in a cross-over, randomized, controlled clinical trial.~        2. To assess the effect of barley β-glucan in a quick bread on appetite-related sensations~          using visual analog scales.~        3. To demonstrate whether the test and reference products were liked or disliked similarly~          by participants.~        4. To assess any gastrointestinal side effects from eating the test products~   "
52653|NCT02367976|"~     The purpose of the study is to evaluate the efficacy and safety of rh-prouk as~     pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is~     designed as a multicenter, active controlled, single blinded study. The primary endpoint is~     to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint~     is to evaluate the mortality rate at day 30.~   "
52654|NCT02367963|"~     Cardiovascular disease is the leading cause of death in Spain and worldwide. Interventions~     targeting dietary patterns, weight reduction and new physical activity habits often result~     in impressive rates of initial behavior changes, but frequently these are not translated~     into long term maintenance. We hypothesize that a peer-group intervention, addressing~     multiple facets of cardiovascular disease risk factor can be successfully implemented~     improving the adherence of participants to healthy habits.~      A multicenter, randomized control trial scheme was adopted. A peer-group based intervention~     approach in which community members support each other to promote health-enhancing changes~     was chosen. Around 600 participants from 7 Spanish municipalities received a 12h initial~     training and were randomly allocated to intervention or control groups for a 12-month peer~     intervention. Baseline measurements took place before and after the initial training.~     Follow-up measurements will be taken at the end of the intervention and 1 and 2 years after~     the end of the study. The primary outcome is the improvement in a newly defined score~     combining 5 individual variables. Secondary outcomes are 1, 2 and 3 years variations in~     anthropometric parameters and/or healthy behaviors.~      The project seeks the empowerment of subjects from 25 to 50 years of age to improve their~     overall health habits and self-control of risk factor through peer education. The initiative~     is being developed in cooperation with the Spanish Agency for Consumer Affairs, Food Safety~     and Nutrition (AECOSAN). This study will allow the economic and feasibility evaluation of~     the intervention, which will enable policy makers to consider its potential wider~     implementation for a real community-based intervention.~   "
52655|NCT02367950|"~     The purpose of the study is to evaluate the feasibility of introducing an exercise programme~     for endometrial cancer survivors.~   "
52663|NCT02367846|"~     This preclinical randomized crossover study will examine the effects of oral versus non-oral~     contraceptive therapy on bone turnover in young exercising women. In an effort to expose the~     route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the~     investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using~     the 41Ca technology and 2) the underlying physiological mechanisms associated with the~     effects of oral versus non-oral contraceptive therapy on net bone calcium balance.~   "
52664|NCT02367833|"~     This study will determine whether the negative effects of combined oral contraceptive (COC)~     therapy on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and bone turnover~     are dependent on the route of administration such that an attenuation of these effects is~     observed when a comparable dose of non-oral transdermal contraceptive (TDC) and~     contraceptive vaginal ring therapy (CVR) are also tested.~   "
52665|NCT02367820|"~     The purpose of this 52-week open label study is to determine the safety of a new opioid~     molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic~     non-cancer pain.~   "
52666|NCT02367807|"~     This is a 48-week prospective observational study that will allow testing of the hypothesis~     that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of~     color who have sex with men (yMSMc) in a community youth drop-in center in conjunction with~     a multifaceted behavioral intervention as well as standard HIV prevention interventions can~     achieve at least 70% retention, as well as a medication adherence rate significantly better~     than that previously reported in the literature. The proposed program evaluation can provide~     critical information for the enhancement and scale-up of successful PrEP programs at FIGHT~     and elsewhere in an effort to make PrEP available to a growing number of persons at risk of~     acquiring human immunodeficiency virus (HIV).~   "
52667|NCT02367794|"~     This randomized, open-label study will evaluate the safety and efficacy of atezolizumab~     (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel~     compared with treatment with carboplatin + nab-paclitaxel in chemotherapy- naive~     participants with Stage IV squamous NSCLC.~   "
52668|NCT02367781|"~     This randomized Phase III, multicenter, open-label study is designed to evaluate the safety~     and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin + Nab-paclitaxel~     compared with treatment with carboplatin + Nab-paclitaxel in chemotherapy-naive patients~     with Stage IV non-squamous non-small cell lung cancer (NSCLC).~   "
52669|NCT02367768|"~     The investigators were looking for resuscitation management, trauma mechanism, risk factors,~     and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma~     patients besides injury severity score (ISS) guiding the traumatologist. The medicare~     resource could be utilized efficiently along with increasing in the survival and quality of~     lifer (QoL) in major trauma.~   "
52670|NCT02367755|"~     Therapeutic hypothermia has been proven to significantly improve the survival and~     neurological prognoses in patients resuscitated from cardiac arrest. Propofol has been~     reported to exhibit potentials in mitigating ischemia-reperfusion injury via the~     antioxidative, anti-inflammatory and neuroprotective mechanisms. This study is to~     investigate the potentials of propofol in further improving the survival and neurological~     prognoses in this era of therapeutic hypothermia.~   "
52671|NCT02367742|"~     It has been demonstrated the essential role of physical activity in the prevention of~     overweight and obesity. Nevertheless, the effect of a program of physical activity on the~     maintenance of body weight in subjects who have previously followed a dietary intervention~     is still unknown. The aim of this study was to investigate this topic by evaluating the~     effect of two different programs of physical activity on subjects who have followed a~     dietary intervention but presented again NAFLD a year after the treatment.~   "
52672|NCT02367729|"~     This study evaluates the effectiveness of a neurostimulator applied to the outer ear for~     adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve~     stimulation to a branch of the vagus nerve which is thought to be involved in transmission~     of pain signals. Half of the study subjects will receive an active nerve stimulator while~     the other half will receive an inactive one.~   "
52673|NCT02367716|"~     The purpose of this clinical study is to observe the safety and efficacy of the multi-vector~     LV lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).~      This is a multi-center, non-randomized observational study.~      The total duration of the study is expected to be 2.5 years. The clinical study will be~     conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled~     in this study. Subjects will be followed up at 3, 6, 12months and every 6 months afterwards.~     All subjects need to be followed for at least 6 months.~   "
52674|NCT02367703|"~     Hysterectomy for benign uterine disease is often intended to young perimenopausal patients.~     Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if~     decreasing the diameter of laparoscopic instruments could reduce postoperative pain and~     improve esthetic result without increasing operative time. The purpose of the study is to~     improve patients' care.~   "
52675|NCT02367690|"~     Patients with eligible diabetic foot ulcers will be screened, treated, and followed for~     complete ulcer closure. This is a randomized trial. All patients will receive~     standard-of-care treatment. Additionally, some patients will receive treatment with topical~     Selinexor gel and some will receive topical placebo gel.~   "
52676|NCT02367677|"~     To compare measurements made by a computer software (ImageJ) made on photographs to the~     traditional clinical measures with a ruler in the evaluation of blepharoptosis~   "
52684|NCT02367560|"~     Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office.~     The chronic and variable course of the condition can lead to dissatisfaction with~     conservative management. Current standard of care at the Thunder Bay Regional Health~     Sciences Centre is referral for treatment by either needle decompression therapy by a~     radiologist or shockwave therapy by a physiotherapist. The purpose of this study is to~     compare the efficacies of these treatment options.~   "
52787|NCT02366195|"~     The study is a phase 2, multi centered, single arm study designed to evaluate the~     correlation between CD8+ cell density and objective response rate in subjects with~     unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and~     tolerability profile of talimogene laherparepvec.~   "
52677|NCT02367664|"~     Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of~     the disease range from subtle changes in behavior to serious problems, including blindness,~     ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs~     primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex~     tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season~     is from June to August and it mainly occurred in children. JE has ranked in top ten~     infectious diseases according to either incidence or mortality. JE vaccines are used to~     protect the population especially young children and infants from encephalitis diseases.~     Live attenuated JE vaccines are now widely used. They are directly produced from attenuated~     virus which may increase the possibility of virulence reversion. Many developed countries~     are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in~     China to develop a new generation of safer and more effective inactivated vaccine to prevent~     and control epidemic encephalitis.~   "
52678|NCT02367651|"~     Pazopanib monotherapy is approved by the Food and Drug Administration (FDA), European~     Medicines Agency, and other regulatory authorities worldwide for the treatment of patients~     with advanced renal cell carcinoma and patients with advanced soft tissue sarcoma (STS) who~     received prior chemotherapy. Based on the improved progression-free survival and sustained~     responses observed in a pivotal Phase 3, randomized, placebo-controlled study, it is~     hypothesized that pazopanib may have a role in a maintenance setting for STS in maintaining~     the initial response to chemotherapy and delaying the need for further treatment at relapse~     and its associated toxicity and impact on health-related quality-of-life. This Phase 2,~     randomized, double-blind, placebo-controlled study will evaluate maintenance therapy with~     pazopanib versus placebo in subjects with advanced or metastatic STS who have not progressed~     after 4 to 6 cycles of first-line anthracycline-based chemotherapy. Approximately 188~     eligible subjects will be randomized in a 1:1 ratio to treatment with pazopanib 800~     milligrams (mg) daily or placebo. Study completion will be the point at which 70% of~     randomized subjects have died. Once a subject has objective evidence of disease progression,~     the subject will be managed as per standard practice by their physician. Subjects will~     continue to be followed for second progression, health related quality of life, survival~     until study completion, withdrawal of consent, or early termination of the study.~   "
52679|NCT02367638|"~     The purpose of this study is to determine whether varicella live vaccine is safe and~     effective in the healthy adults.~   "
52680|NCT02367625|"~     Globally, cervical cancer is the second most common cancer for women and kills approximately~     250,000 women every year, with the annual number of deaths expected to increase to 410,000~     by 2030. The majority (88%) of these deaths occur in low- and middle-income countries~     (LMICs) where screening and prevention services are limited. Prevention of cervical cancer~     by identification and treatment of cervical cancer precursors is key, since treatment~     resources for invasive disease are scarce. A cervical cancer screening program cannot be~     effective unless it is linked with a proven intervention to prevent the development of~     cervical cancer. The World Health Organization (WHO) recently released the WHO guidelines~     for screening and treatment of precancerous lesions for cervical cancer prevention, which~     recommends a screen-and-treat approach for cervical cancer prevention, with cryotherapy~     being the first choice of treatment for women who have a positive screen. However, these~     programs are still slow to be implemented in part due to the current high cost and low~     efficiency of cryotherapy equipment that is often prone to breaking. Jhpiego, an affiliate~     of Johns Hopkins University, has developed a new cryotherapy device, CryoPop, that is one~     tenth the cost of current equipment while also ten times more efficient. Once proven safe,~     feasible and effective, CryoPop could save tens of thousands of lives in low- and~     middle-income countries each year by preventing cervical cancer.~   "
52681|NCT02367612|"~     Respiratory and gastrointestinal infections are common in children under the age of 4 years,~     especially after the start of schooling. These conditions are facilitated by a still~     incomplete functional maturation of the immune system and the anatomical structure and~     function of the respiratory and gastrointestinal tract still developing. The frequency and~     duration of these conditions involves a high discomfort and significant costs, in relation~     to medical appointments, taking medication, the need for hospitalization, days of absence~     from school and work days lost by parents. Functional foods derived from the fermentation of~     cow's milk with probiotic strains have been proposed for the prevention of infectious~     diseases in children. Several products have been investigated, with sometimes conflicting~     results. Diversity in experimental designs, populations evaluated, and bacterial strains~     used in the preparation of fermented products are probably responsible for these~     discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical~     Activities Carlo Romano of the University of Naples Federico II (protocol number 210/12)~     to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the~     prevention of common winter infections in school children aged between 12 and 48 months.~     Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the~     strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the~     cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with~     Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex~     vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of~     experimental colitis. A preliminary analysis of the data was found that subjects treated~     with fermented milk showed fewer infectious episodes, as well as a lower incidence of~     respiratory tract infections or gastrointestinal, with a statistically significant~     difference between the study groups. It was also observed a significant increase in the~     levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with~     fermented milk compared to subjects treated with fermented rice or placebo.~      Therefore, we decided to extend the period of study of five additional months, in order to~     perform an evaluation of the effectiveness of fermented milk (which was more effective)vs~     placebo.~   "
52682|NCT02367599|"~     CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs.~     standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection~     (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case~     control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week~     48. In CCTG 595, plasma from participants are being collected and stored at entry and every~     12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels~     in both cases and controls at entry, week 24, and week 48.~   "
52683|NCT02367573|"~     Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only~     two-dimensional view, which is somewhat challenging when operating in three-dimensional~     environment. The three-dimensional laparoscopic systems are gradually entering the operating~     rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions.~     However, no prospective randomized trials have been published in the clinical point of view.~     Therefore, the purpose of this study is to investigate is there something to gain in~     changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal~     hernia repair.~   "
77618|NCT02041403|"~     An observational trial aiming to verify whether does any relationship exist between renal~     resistive index and postoperative outcome in major high risk surgery~   "
52685|NCT02367547|"~     This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and~     aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in~     photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted~     using randomised prospective double blinded comparing design. Fluorescence is measured in~     A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is~     assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12~     months and 5 years.~   "
52686|NCT02367534|"~     Islet transplantation is one of the effective and promising options for type 1 diabetes~     mellitus treatment1-4. The liver is the primary target location for infusion and portal vein~     catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic,~     laparoscopically transmesenteric and laparoscopically transumbilical approaches were often~     utilized to access the portal. Current islet infusion approach via portal vein of liver has~     various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage~     and portal thrombosis. The laparoscopic entry techniques require longer surgical duration~     and have an increased rate of catheterization failure. Moreover, the catheters were not~     allowed to indwell for subsequent infusions.~      In the current study, the investigators aim to performed open surgery, catheterized the~     umbilical vein and infused islets into the portal vein. The catheter was indwelled for one~     month after surgery. Therapeutic effects, surgical parameters and complications were~     observed to evaluate feasibility and safety.~   "
52687|NCT02367521|"~     Traumatic brain injury (TBI) is frequently complicated by depression and other problems such~     as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and~     behavioral problems. Untreated depression can lead to reduced productivity and poor global~     outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of~     TBI-related depression. The overarching goal of this small study is to determine the~     effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and~     co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a~     brain stimulation technique. It involves generating a brief magnetic field in a coil that is~     placed on the scalp. The magnetic field passes through the skull and induces a weak~     electrical current in the brain that briefly activates neural circuits at the stimulation~     site. Adults aged 18 and older, with a history of head injury of mild or moderate severity ,~     who are currently experiencing symptoms of clinical depression may join the study.~   "
52688|NCT02367508|"~     The study evaluates the feasibility, acceptability, and preliminary efficacy of a~     mindfulness meditation-based intervention designed to provide a synergistic solution to the~     avoidant coping that often inhibits advance care planning discussions that are crucial to~     quality end-of-life care.~   "
52689|NCT02367495|"~     Hypothesis:~      Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with~     citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with~     iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of~     limus-analogue drug-eluting stents (DES)~   "
52690|NCT02367482|"~     In this research study, we will track the build-up of tryptophan, a radioactive tracer, in~     the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural~     state, is an amino acid (one of the building blocks of proteins) that is normally present in~     the brain, and is used by the brain cells to create various other compounds. This process is~     altered in the presence of a brain tumor. By using a form of tryptophan marked with a small~     amount of radiation, we will be able to track this process during the course of the PET~     scan. This research will help determine if AMT PET is a useful method to recognize and~     differentiate between various types of brain tumors. In addition, to study the mechanisms of~     altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and~     related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue~     (in case you will have surgery to remove the tumor). This will help us to find new~     approaches to treat brain tumors in the future by altering abnormal tryptophan metabolism.~   "
52691|NCT02367469|"~     The main purpose of this study is to determine the potential clinical utility of PET imaging~     using the radiotracer [C-11]alpha-methyl-L-tryptophan in the diagnosis, differentiation and~     monitoring of various brain tumors, both before and after initial treatment. We will also~     study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism~     using resected tumor tissues.~   "
52692|NCT02367456|"~     This multi center randomized (1:1), double blind, placebo controlled Phase 1b/2 study is~     designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD)~     of PF 04449913 or placebo when combined with azacitidine in patients with previously~     untreated Intermediate 2 or High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia~     (AML) with 20-30% blasts and multi lineage dysplasia, and Chronic Myelomonocytic Leukemia~     (CMML). This clinical study includes two components: (a) a Phase 1b safety lead in and (b) a~     randomized Phase 2.~   "
52693|NCT02367443|"~     This is a phase I/II trial on concomitant RT-full dose CHT using accelerated~     hypofractionation schedule as currently being in routine use in Poland for sequential~     combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE~     adverse effects related to treatment and to estimate tumor control, progression~     free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC~     patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8~     Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of~     Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is~     evaluated by scoring the toxicity during RT-CHT and therafter, as well as percentage of~     treatment completion; efficacity is evaluated by estimation of local control and survival.~     If toxicity and efficacity are similar or better than those observed in modern series of~     conventionally fractionated RT-CHT, the studied regimen will become a routine treatment~     schedule in our institution in order to spare RT resources. In the future, a randomized~     comparison of the studied schedule with conventionally fractionated RT-CHT for locally~     advanced NSCLC is also planned.~   "
52730|NCT02366949|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2~     dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using~     an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced~     malignancies.~   "
52694|NCT02367430|"~     The purpose of this study is to investigate whether a well-established case management model~     called Critical Time Intervention (CTI) can help individuals with hoarding disorder who are~     concerned about the risk of eviction. Each individual with hoarding disorder will be~     assigned to work with a CTI Specialist for 9 months, who will provide referrals for mental~     health treatment, legal consultations, and registration for entitlements. All participants~     will be offered a facilitated group intervention called the Buried in Treasures Workshop.~     The CTI Specialist will also facilitate reconnecting the individual with supportive~     family/friends and will monitor and support the de-cluttering of the patient's home.~      A second comparison group will be offered the same group intervention (Buried in Treasures~     Workshop) without the other parts of the CTI protocol.~   "
52695|NCT02367417|"~     The objective of this study is to collect outcome information on patients requiring Total~     Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK®~     Endo-Model® SL® under routine conditions.~   "
52696|NCT02367404|"~     Objectives:~      Primary: Comparison of proportion of patient achieving continence between the four arms at 6~     months.~      Secondary:~        -  Comparison of time to achieve continence between the four arms.~        -  Comparison of urinary symptoms and quality of life improvement between the four arms.~        -  Assessment of adverse events in Duloxetine arms.~      Primary outcome/ time frame: Proportion of patient achieving continence at 6 months.~     Continence is defined as using no pador only security pad.~      Secondary outcome:~        -  time to achieve continence~        -  Quality of life tested in relation to incontinence according to Visual Analog Scale~          (VAS) and King's Health Questionnaire (KQH).~        -  Urinary symptoms measured with International Prostate Symptom Score (IPSS).~      No. of subjects entered: 300 patients informed and included, 240 patients will be~     randomized.~      Statistical methods~        -  Proportion of patients who achieve continence and time to achieve continence will be~          compared between the four arms.~        -  Comparison of quality of life outcomes between the four arms~        -  Comparison of clinical variables that can affect the primary/secondary outcome -~          univariate and multivariate analysis (ITT).~   "
52697|NCT02367391|"~     This study is evaluating the feasibility and short term smoking cessation outcomes of an~     automated smoking cessation intervention delivered via mobile phone text messaging as an~     adjunct to Varenicline in a primary care setting.~   "
52698|NCT02367378|"~     The purpose of this study is to collect information on the effect of minimally invasive~     spine tumor decompression on treated patients. This treatment option is less invasive that~     the standard surgical decompression and is expected to result in better wound healing,~     decreased tissue trauma, and decreased pain after surgery.~   "
52699|NCT02367365|"~     Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision~     loss among people over 65. Intravitreal injections with drugs that block VEGF have~     revolutionized treatment of NV AMD. However, less than 40% of treated patients have~     clinically significant imporovement in vision. In this study, we will determine the relative~     frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD~     patient population, and 2) a population of patients who develop recurrent NV AMD activity~     while off treatment and assess the frequency of persistent disease activity (PDA) according~     to specific neovascular morphologic subtypes. This information will clarify the scope of the~     PDA problem and will identify patients with PDA who may benefit from additional therpeutic~     strategies.~   "
52700|NCT02367352|"~     The purpose of this study is to evaluate the safety and tolerability and determine the MTD~     to subsequently define an RP2D of alisertib in combination with weekly paclitaxel in East~     Asian patients with advanced solid tumors.~   "
52701|NCT02367339|"~     Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff~   "
52702|NCT02367326|"~     Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis~     (UC). Its prevalence is high representing approximately 0.4% of the population. The peak~     incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD~     recently reported at 60. These diseases develop over time into complications requiring in~     2/3 of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort~     data has recently shown that the early use of azathioprine from the first year would~     decrease the need for surgery. Aside from biologics, azathioprine is the most widely used~     immunosuppressant in IBD management. Its metabolism is highly variable in the overall~     population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This~     explains partly treatment failures and side effects with thiopurines. A lot of research has~     shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could~     be used clinically even if these results remain controversial. In fact, their positive~     predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot~     be done everywhere, is not reimbursed by national health services, and may not be used in~     some countries. It is, however, key in order optimize these drugs at a time when only two~     anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that~     MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American~     study provided a mathematic formula enabling to achieve over 80% PPV for the clinical~     response on AZA but this calculation needs to be confirmed and it is, moreover, patented~     (costly).~   "
52703|NCT02367313|"~     This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo.~     The objectives are to obtain safety and efficacy data in moderate to severe asthmatic~     patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human~     Rhinovirus infection.~   "
52704|NCT02367300|"~     A prospective, non-randomized trial to validate the database of brain electrical activity~     recordings and clinical information collected from patients who present to the ED following~     closed head injury.~   "
52731|NCT02366936|"~     The purpose of this study is to determine the effectiveness of the Tortle Midliner~     positioning system in prevention and/or treatment of dolichocephaly, which can develop in~     preterm infants during the hospital stay.~      Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and~     treatment strategy for dolichocephaly than current standard of care intervention in the Duke~     Intensive Care Nursery (ICN).~   "
52732|NCT02366923|"~     The study will explore in vivo lens dehydration rates across a 12hr wear period for the~     study lenses.~   "
52733|NCT02366910|"~     The study will explore in vivo lens dehydration rates across a 12hr wear period for the~     study lenses.~   "
52705|NCT02367287|"~     Although the diet of the US population meets or exceeds recommended intake levels of most~     essential nutrients, the quality of the diet consumed by many Americans is sub-optimal due~     to excessive intake of added sugars, solid fats, refined grains, and sodium. The foundations~     and outcomes of healthy vs. unhealthy eating habits and activity levels are complex and~     involve interactions between the environment and innate physiologic/genetic background. For~     instance, emerging research implicates chronic and acute stress responses and perturbations~     in the Hypothalamic-Pituitary-Adrenal axis in triggering obesity-promoting metabolic changes~     and poor food choices. In addition, the development of many chronic diseases, including~     cardiovascular disease, diabetes, cancer, asthma and autoimmune disease, results from an~     overactive immune response to host tissue or environmental antigens (e.g. inhaled~     allergens). A greater understanding is needed of the distribution of key~     environment-physiology interactions that drive overconsumption, create positive energy~     balance, and put health at risk.~      Researchers from the USDA Western Human Nutrition Research Center are seeking volunteer~     study participants for a cross-sectional metabolic phenotyping study of healthy people in~     the general population. Observational measurements include the interactions of habitual diet~     with the metabolic response to food intake, production of key hormones, the conversion of~     food into energy: the metabolism of fats, proteins, and carbohydrates, characteristics of~     the immune system, stress response, gut microbiota (bacteria in the intestinal tract), and~     cardiovascular health. Most outcomes will be measured in response to a mixed~     macronutrient/high fat challenge meal.~   "
52706|NCT02367274|"~     A prospective, non-randomized trial for the extension and replication of the development~     database of brain electrical activity recordings and clinical information collected from~     patients who present to the ED following closed head injury.~   "
52707|NCT02367261|"~     The current prospective clinical study's aim is to determine ABT's SPI implant survival~     rate, crestal interproximal bone resorption during 24 months post implant insertion and to~     assimilate the drilling sequence during the clinical use of SPI implants.~   "
52708|NCT02367248|"~     The main purpose of this study is to determine whether deferoxamine and xingnaojing~     injection is effective and safe as a treatment for intracerebral hemorrhage.~   "
52709|NCT02367235|"~     The purpose of this study is to evaluate the efficiency of the Colpassist vaginal~     positioning device during robotic-assisted sacrocolpopexy.~   "
52710|NCT02367222|"~     The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009~     pandemic was associated with an increased risk of multiple sclerosis (MS) in Manitoba,~     Canada.~   "
52711|NCT02367209|"~     In the recent years a novel method for functional lung imaging called Fourier decomposition~     MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung~     perfusion and ventilation-related information without exposure to ionizing radiation or~     administration of intravenous or inhalational contrast agent. In this project, the~     investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide~     similar clinical information on regional lung perfusion as the standard methods SPECT/CT and~     DCE MRI in patients with COPD.~   "
52712|NCT02367196|"~     CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in~     subjects advanced, refractory solid and hematologic cancers.~   "
52713|NCT02367183|"~     This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome~     and to evaluate its safety in subjects with active Crohn's disease.~   "
52714|NCT02367170|"~     Investigators will assess the effect of exercise on markers of inflammation and protein~     catabolism. This research study will further our understanding of how treating Chronic~     Critical illness (CCI) - related respiratory muscle weakness with strength training can not~     only improve muscle function, but also potentially blunt the inflammation and catabolism of~     Peristent Inflammation/Immunosuppression and Catabolism (PICS).~   "
52715|NCT02367157|"~     The purpose of this study is to determine how the applications of Kinesio Tape affect the~     morning stiffness in patients with rheumatoid arthritis.~   "
52716|NCT02367131|"~     Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese~     elderly patients with type 2 diabetes mellitus.~   "
52717|NCT02367118|"~     The purpose of this study is to determine whether prednisone is effective in the treatment~     of chronic rhinosinusitis without nasal polyps in adult patients.~   "
52718|NCT02367105|"~     The prevalence of obesity in Veterans is greater than in the general population, and even~     more so among users of the VA Health Care System. In addition, the population of obese older~     Veterans is rapidly increasing as more baby boomers become senior citizens. In older~     Veterans, obesity exacerbates the age- related decline in physical function and causes~     frailty which predisposes to admission to a VA chronic care facility. However, the optimal~     clinical approach to obesity in older adults is controversial because of the concern that~     weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and~     bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any~     guidelines for eligible Veterans if they are 70 or older. It is possible that the addition~     of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and~     reverse frailty in obese older Veterans and thus prevent their loss of independence and~     decrease demand for VA health care services.~   "
52719|NCT02367092|"~     The purpose of this study is to learn more about the effects of exercise on functional~     status and outcomes on patients with end-stage liver disease on the liver transplant waiting~     list and who have undergone liver transplantation.~   "
52720|NCT02367079|"~     To investigate the effect of hand massage, switched on diathermy or sham/switched off~     diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.~   "
52721|NCT02367066|"~     A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated~     Doses for 3 days in Subjects with Type 2 Diabetes Mellitus~   "
52744|NCT02366767|"~     The overall aim of this research proposal is to determine the safety, feasibility and~     efficacy of an automatic closed-loop insulin delivery system.~   "
52828|NCT02365662|"~     This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2~     dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of~     ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of~     Epidermal Growth Factor Receptor (EGFR).~   "
52722|NCT02367053|"~     The trial is a randomized, double-blind First in Human trial to evaluate the safety and~     tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D~     (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.~      Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects~     will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a~     single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c.~     in 4-5 cohorts and i.m. in 3 cohorts.~      Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be~     treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential~     cross-over design in a randomized treatment order.~   "
52723|NCT02367040|"~     The purpose of this study is to evaluate whether copanlisib in combination with rituximab is~     superior to placebo in combination with rituximab in prolonging progression free survival~     (PFS) in patients with relapsed iNHL who have received one or more lines of treatment,~     including rituximab. Purpose of the study is also to evaluate the safety and tolerability of~     copanlisib.~      Approximately 567 patients will be randomly assigned in in blinded treatment arms copanlisib~     plus rituximab or placebo plus rituximab.~      Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo dosing~     will be administered on the same days as copanlisib.~      Rituximab dose is administered weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on~     Day 1 of Cycles 3, 5, 7 and 9. The maximum administration of rituximab is 8 times.~      Copanlisib or placebo treatment will be continued until disease progression, unacceptable~     toxicity, or until another criterion is met for withdrawal from the study treatment.~      Following the end of treatment visit, patients will enter either the Safety follow-up or the~     Active follow-up period.~      The efficacy is measured by duration of progression-free survival (time between~     randomization and onset of a further progression of disease, or death from any cause).~     Progression of disease will be determined by radiologic tumor assessments to be performed at~     screening, as well as during the active follow up period tumor assessments every 8 weeks~     during Year 1, every 12 weeks during Year 2, and every 24 weeks during Year 3.~      Blood samples will be collected for safety analysis and pharmacokinetic analysis. Archival~     tumor tissue and blood samples will be collected for biomarker analysis and for central~     pathology review, fresh biopsy tissue and bone marrow will be collected but not mandatory.~   "
52724|NCT02367027|"~     Rivaroxaban is a substance developed for use in the treatment of blood coagulation~     disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity~     in the blood vessels. Excessive coagulation activity can occur in children as well, and~     rivaroxaban is therefore being developed for the treatment of thromboembolic events in~     children and adolescents. As small children are often unable to swallow tablets, an oral~     suspension (mixture of a liquid containing finely distributed solids) has been developed~     which allows dosing according to body weight.The objective of this trial is to compare the~     bioavailability (proportion of a substance that remains available unchanged in the blood~     circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension~     and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential~     influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after~     consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown~     products (metabolites) in blood), safety and tolerability will be assessed.~   "
52725|NCT02367014|"~     This study will be a Phase 1/2, multi-center, randomized, double-blind, multiple ascending~     dose, placebo-controlled study, enrolling an anticipated 36 subjects with mitochondrial~     myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety,~     tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient~     population.~   "
52726|NCT02367001|"~     Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the~     general practitioner involvement (signature) and a more personalized communication in~     invitation letters to organized screening of breast, colorectal and cervical cancers.~      The hypothesis on which this project is based is that communication is probably more~     effective if the receiver feels personally targeted by invitation letters (Dear Martin, I~     am writing ...) and if he knows the issuer (his general practitioner rather an unknown~     person).~   "
52727|NCT02366988|"~     Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and~     in these cases, endoscopy and surgery are the treatment modalities of choice.~     Morbid-mortality of these procedures is similar and physicians face the decision between~     endoscopy and surgery for this group of patients, with no randomized controlled trial~     available comparing these procedures.~      The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of~     surgical and endoscopic interventions in the management of bile duct stricture for chronic~     pancreatitis.~      The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary~     end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical~     procedures, length of stay. Eighty-six patients need to be included.~   "
52728|NCT02366975|"~     There are many evidences in the literature showing that the metabolic syndrome (MetS) is~     associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated~     with both conditions, thus being one of the most probable pathogenetic factor underlying the~     association between MetS & BPH / LUTS.~      Preliminary evidences from observational clinical studies have shown that treatment with~     testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower~     urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the~     investigators research group show in an experimental model of metabolic syndrome the~     occurrence of marked inflammation and tissue remodeling of the prostate gland, which is~     prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is~     therefore a need for a clinical trial to demonstrate the effect of treatment with~     testosterone replacement in reducing the inflammation of the prostate and its effectiveness~     in improving the symptoms related to inflammation in patients with prostatic BPH associated~     with metabolic syndrome and testosterone deficiency .~      The aims of the present study is to evaluate the effectiveness of testosterone replacement~     therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate~     and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates~     for radical prostatectomy simple.~      For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by~     questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and~     assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score,~     IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation:~     macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines~     in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis~     of samples prostate derived from patients enrolled in the study or not treated with~     testosterone) scores will be performed. Along with the symptoms and clinical signs of~     prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile~     erection will be also evaluated.~   "
52729|NCT02366962|"~     The purpose of this study is to confirm the safety until Day 29 after injection of a single~     dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older~   "
52734|NCT02366897|"~     The project is aimed at addressing the fundamental issue in antipsychotic therapeutics -the~     balance between mental state benefits and neurological risks.The latter cannot be~     overestimated and clinical skills in themselves are inadequately sensitive to refine~     practice. With all current and pipeline antipsychotics based on central dopamine blockade,~     there is little prospect that therapeutics can be improved by advances in pharmacology~     alone.~      The project uses, for the first time, technology that is not only simple, real-life and~     user-friendly but modern and socially held in high regards. The proposal depends on~     patients receiving antipsychotic medication where clinically indicated. At all times,~     subjects will receive clinically-indicated therapy. The major ethical issue will relate to~     the issue of informed consent in those suffering from major psychiatric disorder. This is a~     routine consideration in psychiatric practice and the investigators will seek guidance on~     this from the Consultant Psychiatrist responsible for potential participants and would not~     proceed with initial approaches in cases of doubt or absence of capacity.~      This is a pilot/feasibility study with no intention to utilise the data for~     commercialisation of the device or to expand the CE (Conformité Européenne) marking.~   "
52735|NCT02366884|"~     The cell behavior that the investigators regard as malignant, including: cell autonomy;~     invasion and digestion of surrounding normal tissues; migration and colonization of distant~     organs; ability to develop resistance to drugs, temperature, or radiation; and ability to~     kill the host, are not only characteristics of cancer cells, but of pathogenic and/or~     opportunistic unicellular organisms (bacteria, fungi and protozoa). Rudolf Virchow~     (1821-1902), the father of modern pathology, first pointed out the resemblance between the~     biological behavior of cancer cells and that of single-celled organisms when causing~     infections. He thought, incorrectly, that cancer cells were cells infected with bacteria and~     had acquired their pathogenic behavior from them. Others later postulated that the behavior~     of cancer cells was likely due to the re-expression of past traits and behaviors (atavism)~     derived from their past evolutionary experience as independent, single-celled organisms from~     which all cells in multicellular organisms originated. In other words, the behavior of~     pathogenic unicellular organisms, including: unlimited replicative potential; capacity for~     invasion, migration, and metastases; abilities to evade the host's immune system, to~     generate multi-drug resistance; and to kill a host, are what the investigators define as~     cancer when one of the investigators cells re-express these past ancestral traits. This~     reversion or de-evolution of a differentiated cell to its ancestral undifferentiated,~     unicellular form has been named Atavistic Metamorphosis.~      This does not imply that cancer cells are bacteria, protozoa, or yeasts. It means that~     cancer cells express functions and/or behaviors similar to their ancestral parents, the~     unicellular organisms from which our cells originated.~      If this is true, a combination of drugs that are effective to eradicate certain unicellular~     organisms may work in cancer treatment.~      The principal objective of this study is to determine whether there is a benefit for~     patients with advanced, metastatic and terminal cancers to be treated with combinations of~     selected drugs conventionally used in medical practice to kill bacterial, fungal and~     protozoal cells.~   "
52736|NCT02366871|"~     The study will evaluate the incidence of major bleeding (including clinically relevant~     non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with~     apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD~     for 28 days post surgery.~   "
52737|NCT02366858|"~     The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the~     need to use the 19 gauge needle for core tissue procurement.~   "
52738|NCT02366845|"~     This study plans to learn more about transfusion of a human blood component called plasma in~     patients who have liver problems. Patients are asked to be in this study because they have~     liver disease and therefore may require the transfusion of plasma.~      The dose of plasma required to reach certain blood clotting laboratory targets is usually~     determined by clinicians. Due to the complexity of the patient's blood clotting disorder,~     determining the appropriate dose of plasma is very difficult. The investigators have~     developed a dosing table based on information from other patients with liver disease and the~     investigators are testing it to see if it is a more accurate dosing tool then clinician~     chosen dosing of plasma in patients with liver disease who need one or more plasma~     transfusions~   "
52739|NCT02366832|"~     The purpose of this study is to determine if treatment with percutaneous cryoablation yields~     significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).~   "
52740|NCT02366819|"~     This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of~     modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin~     (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread~     from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as~     fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Leucovorin calcium may also help~     fluorouracil work better. Genetic analysis may help doctors determine what dose of~     irinotecan hydrochloride patients can tolerate.~   "
52741|NCT02366806|"~     This study is being conducted to investigate the effect of a more in-depth education plan~     for patients with breast cancer. Patients will be randomized to receive either the standard~     education plan during their breast cancer treatment or they will receive in-depth education~     about their breast cancer treatment. In order to see what kind of effect the different~     education plans have, patients will fill out three identical questionnaires during the~     course of treatment.~   "
52742|NCT02366793|"~     The potential consequences after breast cancer surgery are joint pain and sensitive~     disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy~     has been shown to be effective at increasing shoulder range of motion restriction. However,~     literature does not consider specific manual therapy techniques, which means peripheral~     nerves and articular capsule have not been taken into account. These two tissues are~     potentially damaged structures during surgery and they are main responsible for shoulder~     range of motion restriction The main objective of this study is to pilot the effectiveness~     of accessory joint and nerve mobilization techniques in order to get an overview of the~     articular capsule and nerve dysfunctions involvement in shoulder motion restriction.~   "
52743|NCT02366780|"~     Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive~     factors for the health and development of infants.Colostrum, which is produced in low~     quantities for the first 3 to 4 days after birth, is rich in immunologic components and~     developmental factors.~      Breastfeeding difficulties during the first days of life of an infant are common. Moreover,~     not all infants can be directly fed at the breast.~      Therefore, breast milk feeding at this early stage is initiated and promoted by the~     expression of breast milk either manually or by use of a pump. Whether the method of milk~     expression at this stage has a qualitative impact on colostrum is currently unknown.~      The purpose of this randomized controlled study is to compare the effect of manual~     expression with electric pump expression upon the macronutrient composition of breast milk.~   "
52745|NCT02366754|"~     The purpose of this study is to address the need for targeted treatments that induce~     functional and structural changes in the brain, ultimately improving neurobehavioral~     functioning, the investigators propose examining the therapeutic effectiveness of repetitive~     Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery~     for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months~     after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the~     relationship between neurobehavioral changes and net neural effects, and to identify and~     define the neural mechanisms related to neurobehavioral improvements by providing 30 active~     or placebo rTMS sessions.~   "
52746|NCT02366741|"~     Small cell lung cancer (SCLC) harbors a high risk for brain metastases. Prophylactic whole~     brain radiotherapy (PCI)) is the standard treatment for these patients after completing~     chemo-radiotherapy to the chest, with a 5% survival advantage. Recent data suggest minimal~     risk for hippocampal involvement in these patients. There is no published data thus far~     testing the effect of hippocampal sparing during WBRT on the patient's neuro-cognitive~     function, QOL, and survival.., The goals of the proposed study are to assess prospectively~     the neurocognitive changes in patients with LD SCLC who are candidates for PCI before, and~     periodically after PCI~   "
52747|NCT02366728|"~     This randomized phase II study will assess the impact of pre-conditioning on migration and~     survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive~     resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the~     impact of tetanus pre-conditioning and basiliximab together on survival. After completing~     standard of care radiotherapy with concurrent TMZ, patients will be randomized to 1 of 3~     treatment arms: 1). receive cytomegalovirus (CMV)-specific dendritic cell (DC) vaccines with~     unpulsed (not loaded) DC pre-coinditioning prior to the 4th vaccine; 2). receive~     CMV-specific DC vaccines with Tetanus-Diphtheria Toxoid (Td) pre-conditioning prior to the~     4th vaccine; 3). receive basiliximab infusions prior to the 1st and 2nd DC vaccines along~     with Td pre-conditioning prior to the 4th vaccine. A permuted block randomization algorithm~     using a 1:1:1 allocation ratio will be used to assign patients to a treatment arm.~     Randomization will be stratified by CMV status (positive, negative), with the assignment to~     arms I and II being double-blinded.~   "
52748|NCT02366715|"~     Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major~     cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and~     IV fluids, whereas other supportive therapies such as inhalations are of questionable~     benefit. Moderate to severe cases are a source of distress to patient, parents and medical~     staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High~     Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing,~     oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and~     intubation rates. We planned a prospective and retrospective study in order to check the~     feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well~     being, respiratory status and PICU admission.~   "
52749|NCT02366702|"~     The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal~     plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral~     transfemoral walking with passive prostheses versus powered prostheses. The pilot study will~     collect data from three subjects with bilateral transfemoral amputations. Differences in~     kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered~     components may indicate benefits for clinical application of powered devices for persons~     with lower limb amputation.~   "
52750|NCT02366689|"~     The objective of this clinical research study is to assess the efficacy of a commercially~     available triclosan/copolymer toothpaste compared to a commercially available oral hygiene~     multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing~     stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium~     chloride relative to a negative control regimen in reducing established dental plaque and~     gingivitis over three and six months of assigned product use.~   "
52751|NCT02366676|"~     The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With~     Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory~     to Escherichia Coli Extract~   "
52752|NCT02366663|"~     This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination~     chemotherapy compared with combination chemotherapy alone before stem cell transplant in~     treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a~     period of improvement. Radioactive substances linked to monoclonal antibodies, such as~     90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may~     help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate,~     cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether 90-yttrium ibritumomab tiuxetan and BEAM before a~     stem cell transplant are more effective than BEAM alone in treating patients with diffuse~     large b-cell non-Hodgkin lymphoma.~   "
52753|NCT02366650|"~     The purpose of this prospective, non-interventional clinical study is to assess the clinical~     validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin~     (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the~     presence of organ dysfunction, or outcome, of patients with organ dysfunctions following~     emergency department admission or hospitalization. Secondary objectives are to identify~     novel putative biomarkers and to identify risk factors for negative long-term effects of~     acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the~     quantitative determination of Heparin Binding Protein in human plasma.~   "
52754|NCT02366637|"~     This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with~     moderate to severe Chronic Obstructive Pulmonary Disorder.~   "
52785|NCT02366221|"~     The specific aim of the study is to obtain long-term follow-up information on patients who~     have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity~     Service. The study will help to qualify and quantify long-term recovery and outcomes from~     uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The~     hypotheses vary, but generally focus on the patterns of injury, the results of treatment and~     the complications encountered.~   "
52755|NCT02366624|"~     The purpose of this study is to evaluate the effect of bariatric surgery in bile acid~     homeostasis and its interrelationship with the metabolic changes induced by the surgery.~      This study contemplates the following hypothesis:~        -  Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile~          acid synthesis in association with increased bile acid content.~        -  The major effects of bariatric surgery on bile acid synthesis and is observed one month~          after surgery with a progressively decline during the first year of follow-up.~        -  Gastric bypass increases serum bile acid content, postprandial plasma bile acid~          response and fecal bile acid excretion.~        -  Serum bile acids changes induced by gastric bypass are positively correlated with~          changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration~          of insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with~          thyrotropic hormone (TSH) and postprandial concentration of glucose.~        -  Changes in postprandial plasma bile acid response induced by gastric bypass positively~          correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY~          (PYY) and inversely correlates postprandial response of ghrelin and glucose.~   "
52756|NCT02366611|"~     The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS)~     can reduce pain perception associated with the effects of receiving definitive radiation~     therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.~   "
52757|NCT02366598|"~     The objectives of this trial are to assess the health benefits of acute hemp protein~     consumption compared to soybean protein and a non-protein control on: 1) blood glucose,~     appetite and blood pressure for one hour following consumption, 2) food intake at an ad~     libitum meal one hour following consumption and 3) blood glucose, appetite and blood~     pressure following the ad libitum meal to determine the second meal effect of hemp~     protein.~   "
52758|NCT02366585|"~     The main purpose of the trial is to investigate the effect of locally delivered ciclosporin~     as an adjunct to non-surgical mechanical debridement in the treatment of chronic~     periodontitis and to compare it to mechanical debridement alone.~   "
52759|NCT02366572|"~     The objectives are to test the acute effects of different cereals containing pulse~     ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2)~     food intake two hours following consumption of pulse products.~      We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose,~     insulin, appetite and food intake responses compared to non-pulse cereals.~   "
52760|NCT02366559|"~     The primary objective of this study is to compare the efficacy and risk of adverse events of~     electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG)~     laser for the treatment of flat seborrheic keratoses.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
52761|NCT02366546|"~     Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene~     transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid~     tumors.~   "
52762|NCT02366533|"~     The goal of ATN 093 is to determine program-level factors associated with the effectiveness~     of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent~     Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the~     various LTC programs at the AMTUs and then examining the association between the LTC program~     characteristics (providers, practices, and systems) and the proportion of Human~     Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care~     and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit~     of analysis and not the youth themselves.~   "
52763|NCT02366520|"~     The purpose of this study is to determine whether a handheld mirror helps to reduce child~     behavior problems during dental treatment. It will be tested by randomized crossover design.~     Child participants will receive dental treatment under two conditions: during one of the~     treatment days the child will be given a handheld mirror; another treatment will be done~     without the child having the mirror. Each condition will be assign on separate days, and the~     day, which the child has the mirror, will be assigned by chance.~   "
52764|NCT02366507|"~     Traditional devices to measure blood pressure include automatic sphygmomanometer (pressure)~     cuff systems or manual blood pressures obtained by auscultation (listening with a~     stethoscope). Both these techniques fail to provide accurate and consistent blood pressure~     in the hypotensive (low blood pressure) state, which is often encountered in emergency~     departments and intensive care units. Alternately, invasive arterial pressure measurement is~     time-intensive, painful, expensive, and risks include bleeding, infection, and neurovascular~     injury.~      In clinical practice, the Doppler velocimetry system is occasionally used in hypotensive,~     critically-ill patients when an immediate systolic blood pressure measurement is vital for~     clinical and therapeutic management. With a technique similar to that used to obtain a~     manual blood pressure, the Doppler velocimetry system can be used in place of the~     auscultation of the brachial pulse to accurately determine the systolic blood pressure. It~     is currently unknown whether additional information can be obtained by evaluation of the~     Doppler waveform in healthy vs. critically-ill patients. The goal is this project is to~     digitally record Doppler waveforms of critically-ill patients in the Emergency Department~     (ED) via a standard 8MHz (fetal) Doppler probe, correlate the Doppler readings with current~     blood pressure and heart rate, and determine if waveform shapes and parameters are~     predictive of hemodynamic compromise.~   "
52765|NCT02366494|"~     Identify exosomal micro RNA that predict responses to ADT~   "
52766|NCT02366481|"~     Given that glutamate carboxylation or decarboxylation is key to the metabolic role of~     osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is~     critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and~     its subsequent effect on glucose metabolism in clinical trials. The purpose of this~     randomized, double-blind, placebo-controlled clinical trial in adults is to determine~     whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve~     markers in blood associated with diabetes risk.~   "
52767|NCT02366468|"~     The purpose of this study is to demonstrate that the change of best corrected visual acuity~     (BCVA) is comparable in patients treated with ranibizumab at the discretion of the~     investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).~   "
79718|NCT02013999|"~     Using the upper extremity rehabilitation program developed by virtual reality would help the~     recovery upper extremity function in patients with stroke.~   "
52768|NCT02366455|"~     The right-sided double lumen endobronchial tube (R-DLT) is seldom. The principal cause of~     reticence for using the R-DLT are the difficult positioning of its lateral orifice in front~     of the origin of the right upper lobe (RUL) and the variability of the length of the right~     main stem bronchus (RMSB). Both the angle between the right upper lobe (RUL) bronchus origin~     and the RMSB and the length of the RMSB can be measured with high resolution CT-scan. These~     measures can be useful in clinical practice as they help to determine when a R-DLT should~     not be used or used with caution when facing a large variation of the angle of the RUL or a~     proximal implantation of a RUL bronchus .~   "
52769|NCT02366442|"~     The overarching goal of the proposed study, named SYNERGY, is to explore relationships among~     balance performance, cognitive function, affective dysregulation, as they relate to the~     community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the~     development of a better outcome models for the clinicians in facilitating effective~     community re-integration in Veterans with TBI~   "
52770|NCT02366429|"~     Randomized controlled trial evaluating an Internet-delivered Cognitive Behavioral Therapy~     (ICBT) adapted for pregnant women suffering from antenatal depression. The ICBT-program will~     be added to treatment as usual (TAU) and compared to TAU only.~      Participants (n=60) are recruited from all over Sweden (only Swedish citizens can~     participate) and are assessed and treated on a distance via a secure web platform and~     telephone.~   "
52771|NCT02366416|"~     The aim of this study is to investigate the effects og physical exercise on bloodglucose and~     pain from the musculoskeletal system in patients with type 2 diabetes.~      The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long~     term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients~     will be stratified to patients with a high or a low degree of complications related to~     diabetes.~   "
52772|NCT02366403|"~     Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure~     to a traumatic event. The purpose of this study is to determine whether a breathing~     meditation technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as~     effective as the standard intervention. Patients' PTSD symptoms will be monitored before~     treatment, at the end of treatment, one month after treatment and 12 months after treatment.~   "
52773|NCT02366390|"~     The purpose of this trial is to determine whether a minimal homebased psychoeducative~     intervention is effective in management of anxiety and dyspnea in patients with severe~     chronic obstructive pulmonary disease.~   "
52774|NCT02366377|"~     The purpose of this study is to evaluate the efficacy and safety of 3 different doses of~     SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving~     treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate~     glycemic (blood sugar) control.~   "
52775|NCT02366364|"~     The purpose of this study is to assess the safety and tolerability of multiple oral (PO)~     ascending doses of NRX-1074 in normal healthy volunteers.~   "
52776|NCT02366351|"~     The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824~     over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the~     effect of SHR3824 to placebo when given in oral doses.~   "
52777|NCT02366338|"~     Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was~     shown to decline by oral anticoagulant therapy. The investigators intended to evaluate~     appropriate use of anticoagulants in non-valvular AF patients.~   "
52778|NCT02366325|"~     The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic~     kidney disease (CKD) who are on hemodialysis.~   "
52779|NCT02366312|"~     The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge~     (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety~     of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin~     cancer. However, the drug is experimental for patients with KCOT.~   "
52780|NCT02366299|"~     Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of~     delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b~     in serum.~   "
52781|NCT02366286|"~     The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States~     (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan~     Africa have substantially higher prevalence than the general population and are consequently~     at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence~     rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have~     changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but~     current estimates put the number at around 50,000 due to primary refugee arrivals as well as~     secondary immigration from other states. There is no available data for Somali immigrants in~     the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and~     immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development~     of HCC. Therefore. this study will fill these gaps in the Somali population to understand~     the relative importance of HBV and HCV infections in causation of HCC.~   "
52782|NCT02366273|"~     Patients with psoriasis will be evaluated. The investigators will collect personal history,~     concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired~     fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if~     there is a correlation among inflammation, insulin-resistance and psoriasis.~   "
52783|NCT02366247|"~     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1~     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from~     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with~     chronic hepatitis B.~   "
52784|NCT02366234|"~     AIM:~      The aim of this study is to assess whether patients with an acute distal tubercle fracture~     of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of~     symptoms and disability 6 months after injury as the average for the normal population.~      NULL HYPOTHESIS:~      Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH~     (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score~     of 13 in Norway and 10.9 in the United States) 6 months after injury when treated~     symptomatically with a removable brace.~   "
52788|NCT02366182|"~     Failed intubation and ventilation in obstetrics remains one of the most common causes of~     death directly related to anesthesia. The reported incidence of failed intubation in~     obstetrics is 1:300, which is significantly higher than that in the non-obstetric~     population. A clinical screening test with high sensitivity and specificity for prediction~     of difficult airway may help reduce morbidity and mortality from general anesthesia. Few~     studies have identified increased neck circumference as the best single predictor of~     problematic intubation. However the cutoff point of this test for identifying patients at~     high risk of difficult intubation is not clear.~      The aim of this study is to determine the optimal cutoff point, which validates prediction~     of difficult ventilation and/or intubation for obstetric patients. Preoperative airway~     assessment will be done including neck circumference. Intraoperative difficult ventilation~     and/or intubation will be recorded. Optimal cutoff point of neck circumference will be~     calculated by Receiver Operating characteristics (ROC) curve.~   "
52789|NCT02366169|"~     This registry is intended as an observational, post-marketing surveillance tool. The~     registry allows collection of baseline demographics and user experience of the commercially~     available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a~     large number of subjects during use outside the constraints of a prescribed clinical study.~   "
52790|NCT02366156|"~     This study will evaluate the effects of encapsulated botanical extracts, previously shown to~     inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and~     postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently~     healthy, overweight and obese adult men and women.~   "
52791|NCT02366143|"~     This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab~     (MPDL3280A) in combination with carboplatin and paclitaxel with or without bevacizumab~     compared with treatment with carboplatin plus (+) paclitaxel and bevacizumab in~     chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (NSCLC).~   "
52792|NCT02366130|"~     The goal of this clinical research study is to learn if Xofigo® (also called Ra-223~     dichloride) combined with hormone therapy and denosumab can help to control breast cancer~     that has spread to the bones and/or bone marrow. The safety of this study drug combination~     will also be studied.~   "
52793|NCT02366117|"~     The study design is that of a cluster randomised controlled trial~      The aims of the study were: 1) to assess the quality of care of the residential units for~     people with long-term mental disorders; 2) to design a training intervention for the staff~     of the units in the intervention group; 3) to assess the effectiveness of the intervention 4~     and 8 months after it ended.~      The main outcome variable was level of activity of the users. Secondary outcome variables~     were the QuIRC dimensions.~      The selection of the sample was by residential units for people with long-term mental~     disorders.~      The inclusion criteria were all the middle and high-support residential units in Portugal.~     Units that had only one type of service users (e.g., mental retardation, dementia) were~     excluded.~      The quality of care of the units was assessed with the QuIRC filled on line by the managers~     of the units and validated with Service Users Interview Schedule, a face-to-face interview~     with the users (users that could not give informed consent or collaborate in the interview~     were excluded).~   "
52794|NCT02366104|"~     BSHA is a cohort study of healthy elderlies enrolled voluntarily. It has been ongoing since~     December 2008. And the purpose of this study is to assess clinical and biological markers of~     cardiovascular risk in very elderly participants.~   "
52795|NCT02366091|"~     The investigators are studying whether anti-inflammatory agents can improve abnormal~     coronary artery function in patients with coronary artery disease (CAD) and abnormal~     coronary artery function.~   "
52796|NCT02366078|"~     The purpose of this study is to investigate the outcomes of the Stress Management and~     Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota.~     Feasibility of a blended in-person and online teaching approach of the program will also be~     evaluated.~   "
52797|NCT02366065|"~     - Lowering intraocular pressure is the only proven treatment for glaucoma. Medications,~     almost always in the form of eye drops, are a mainstay for lowering intraocular pressure.~     Eye drops have the disadvantage of being difficult to administer and can have adverse~     effects on the surface of the eye and the surrounding tissues. Lowering intraocular pressure~     can be accomplished with oral carbonic anhydrase inhibitors, but the many systemic side~     effects of these agents relegates them to drugs of last resort. Therefore, an effective,~     well-tolerated, oral agent would be an important addition to the treatment of glaucoma. The~     hypothesis is that oral acetaminophen can lower intraocular pressure to a clinically~     significant degree in a dosing regimen that is both safe and convenient. The research is~     important because acetaminophen is inexpensive, available over-the-counter, and has a well~     known safety and side effect profile.~   "
52798|NCT02366052|"~     The main aim of the study is to determine if an oral supplementation of the LCS has a~     beneficial effect by itself or even enhances the beneficial effects of a moderate life-style~     intervention on the progression of NAFLD in humans.~   "
52799|NCT02366039|"~     This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric~     Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and~     ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard~     histopathology~   "
52800|NCT02366026|"~     The primary objective is to compare & evaluate between the treatment groups the changes in~     decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax~     placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+~     & CD8+ T cell counts along with increased HIV immunity.~   "
52801|NCT02366013|"~     This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1~     vaccine.~   "
52802|NCT02366000|"~     The aim of this study is to identify parent-children communication in relation to health~     risk behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance~     better parental skills in preventing these behaviors in children.~   "
52803|NCT02365987|"~     The purpose of this study is to investigate whether there are differences in postprandial~     metabolic indices following interesterified fats used in commercial spreads versus the~     corresponding un-interesterified blend.~   "
80041|NCT02009761|"~     BI 655064 will be administered subcutaneously once weekly in patients with immune~     thrombocytopenic purpura (ITP) for up to 12 weeks.~   "
52804|NCT02365974|"~     Uncontrolled blood pressure represents the main factor in the development of target organ~     lesions and, consequently, cardiovascular events, which are the leading cause of morbidity~     and mortality worldwide. In most cases resistant hypertension is preceded by target organ~     lesions, and is strongly influenced by risk factors or associated diseases. To control this~     disease requires an adequate and intense therapeutic approach that includes lifestyle~     changes and the use of several antihypertensive drugs. However, the results are not always~     satisfactory despite intensive treatment. Of the different pathophysiological mechanisms~     involved in the pathogenesis of resistant hypertension (RH), two, sympathetic~     overstimulation and therapies that block the sympathetic system, have been widely studied.~     But, these approaches are invasive and expensive. Another possible approach is by~     transcutaneous electrical nerve stimulation (TENS), a non-invasive method that modulates~     activity by inhibiting primary afferent pathways using low-frequency transcutaneous~     electrical stimulation. Some studies have shown that TENS reduces blood pressure in patients~     with hypertension. The current study will evaluate the effect of applying TENS in the~     cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low~     cost and readily available therapy to treat this group of hypertensive individuals.~   "
52805|NCT02365961|"~     Patients undergoing a hip scope procedure will be recruited for this study. They will be~     randomized to either receive a nerve block or no nerve block (pain medicine only). Pain~     levels and clinical outcomes will be assessed through 3 months post-operatively.~   "
52806|NCT02365948|"~     This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and~     evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to~     receive one of 3 dose levels of CZP or placebo. The total study duration will be~     approximately 71-94 days for each subject.~   "
52807|NCT02365935|"~     The investigators primary outcome was to evaluate the effectiveness in term of Overall~     Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic~     regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB)~     previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS).~      The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of~     the two treatment options.~   "
52808|NCT02365922|"~     Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of~     rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes:~     frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration~     syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is~     to build a FTLD clinical research consortium to support the development of FTLD therapies~     for new clinical trials. The consortium, referred to as Advancing Research and Treatment for~     Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner~     with six patient advocacy groups to manage the consortium. Participants will be evaluated at~     14 clinical sites throughout North America and a genetics core will genotype all individuals~     for FTLD associated genes.~   "
52809|NCT02365909|"~     Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in~     approximately 1% of cases when performed in obstetric patients. The gold standard treatment~     for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back~     into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood~     through the needle and into the epidural space to form a clot over the insult in the tissue~     layer that causes the headaches. The investigators want to test the efficacy of using a less~     invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has~     been used for many years in the treatment of migraines and cluster headaches, and there are~     several case reports of its use to successfully treat PDPH as well. SPGB simply involves~     applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves~     that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH~     patients that require and EBP.~   "
52810|NCT02365896|"~     Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety~     Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal~     Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally~     Advanced Gastric Cancer~   "
52811|NCT02365883|"~     The purpose of this study is to image human prostate tissue using a new transrectal~     photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed~     once the specimen has been surgically removed. We hope to see what we can visualize with our~     device as this has never been done before. Eventually, we hope to use a similar device to~     image the prostate in men being seen by their doctor for prostate cancer.~   "
52812|NCT02365870|"~     This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing~     anxiety in people with Parkinson's disease.~   "
52813|NCT02365857|"~     A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and~     side effect profile of different dose levels of Dexmedetomidine added to subarachnoid~     bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal~     anesthesia. The investigators ultimate goal is to find out the least effective dose which~     will be associated with minimal or no side effects. The primary outcome will be the time to~     two sensory block segment regression.~   "
52814|NCT02365844|"~     The purpose of this study is to characterize the blood supply at the base of the tongue and~     within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will~     improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better~     assessment of tumor and thus providing better preoperative expectations to patients with OPC~     or tumor extent prior to radiation therapy.~   "
52829|NCT02365649|"~     To determine the efficacy and safety of multiple doses of ABT-494 in subjects with~     moderately to severely active Crohn's Disease with a history of inadequate response to or~     intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.~   "
52830|NCT02365636|"~     This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment~     compared with placebo ointment applied topically and twice daily to the area of PHN pain for~     4 weeks in patients with PHN~   "
52831|NCT02365623|"~     The purpose of this study is to explore safety and efficacy of TMC207 administered as part~     of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary~     multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207~     and its primary metabolite M2.~   "
52815|NCT02365831|"~     While therapeutic strategies for HER2-positive breast cancer are well defined, there is not~     a standard strategy for HER2-negative tumors.~      Because of lack of information related to the the factors affecting the choice of a~     particular treatment strategy, as well as the optimization of the correct sequence of~     treatments, the choice of the treatment for the advanced disease remains highly empirical~     and may differ significantly among the different cancer centers.~      The purpose of this study is the observation of a cohort of patients with metastatic~     HER2-negative in terms of:~        1. the choice of chemotherapy treatments starting from the first line of treatment;~        2. factors that may influence these choices;~        3. correlation among the characteristics of patients (age, menopausal status, etc.) and~          type of adjuvant and metastatic treatment ;~        4. clinical outcome (pattern of relapse, time from diagnosis, etc.);~        5. evaluation of the adherence to the literature's recommendations for therapeutic~          sequences in clinical practice.~   "
52816|NCT02365818|"~     To study the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high~     grade non muscle invasive bladder cancer patients who failed BCG therapy and refused~     cystectomy.~   "
52817|NCT02365805|"~     Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer.~     Response of breast cancer to NAC is correlated with survival: patients who obtain greatest~     survival advantage are those who attain complete response of their primary tumor. BReast~     Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA~     expression and sensitivity to platinum and/or resistance to taxanes has been previously~     documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to~     compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC~     chemotherapy, being pathological complete response the primary endpoint.~   "
52818|NCT02365792|"~     The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care,~     taking care on the one hand of patients suffering from time-sensitive critical conditions~     like STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients~     whose lives are not in immediate danger but suffer from acute exacerbation of chronic~     conditions or suffer from acute pain.~      In the current study the investigators will use a multistage approach to test the hypothesis~     whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence,~     2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without~     impeding the workflow of the prehospital team or impairing patient safety.~   "
52819|NCT02365779|"~     High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with~     an important mortality due to late diagnosis. However the prognosis is excellent in the~     early stages of the disease. Recently it has been described a new serous carcinogenic~     sequence from the fallopian tube with tubal precancerous lesions. Therefore the~     identification of these early preinvasive lesions would be of great interest in the~     population with hereditary predisposition for ovarian cancer (concept of oncofertility) and~     in the general population (to determine whether bilateral salpingectomy has to be performed~     during a hysterectomy for benign disease).~      The optical biopsy has been developed and validated in the detection of early precancerous~     lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective~     of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the~     study of fallopian tubes during laparoscopy with correlation between the histopathological~     and immunohistochemical analysis and the endomicroscopy image interpretation. The second~     objective is to describe the optical biopsy pictures in order to state a classification.~   "
52820|NCT02365766|"~     This is a pre-surgical study involving subjects with muscle invasive bladder cancer, or~     urothelial cancer, who are candidates for neoadjuvant therapy. It is is a two-part trial~     with a one-arm phase Ib portion followed by a two-arm phase II portion. The study treatment~     is stratified into two cohorts based on cisplatin eligibility.~   "
52821|NCT02365753|"~     A double-blinded randomized control study using a pulsed electromagnetic field therapy to~     establish whether this device decreases patient pain and decreases narcotic use in women who~     have undergone cesarean delivery.~   "
52822|NCT02365740|"~     This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients~     (DM1) free of chronic complications in comparison with a group of healthy control subjects.~     The investigators will also assess the relationship between GE and glucose control (HbA1c,~     postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and~     gastrointestinal symptoms.~      In addition, in patients with delayed GE the investigators will investigate the effect of~     tailored pre-prandial insulin bolus administered by means of insulin pump in reducing~     postprandial glucose variability, evaluated through continuous glucose monitoring system.~   "
52823|NCT02365727|"~     Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block,~     standard of care for this procedure, or Exparel alone for pain management after surgery.~     They will also be asked to complete questionnaires before surgery, during their stay at the~     hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess~     pain and/or function levels, as well as the amount of pain medicine patients have used after~     surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6~     and 12 months after surgery.~   "
52824|NCT02365714|"~     This study will prospectively evaluate the technical feasibility, acute toxicity, late~     effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast~     Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL)~     issues as they relate to treatment-related side effects and cosmetic results.~   "
52825|NCT02365701|"~     This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in~     patients with Functional Dyspepsia as measured by change in maximum tolerated volume and~     aggregate symptom score on the nutrient drink test.~   "
52826|NCT02365688|"~     The purpose of this study is to retrospectively evaluate the hemodynamic response to goal~     directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy~     is a standard of care after establishing a pre-incision baseline response to fluids.~   "
52827|NCT02365675|"~     The purpose of this study is to compare the efficacy of four dressings (covers) namely:~     gauze with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with~     silver and nanocrystalline silver to improve the new growth of skin, reduce pain and itch in~     persons suffering from pemphigus and pemphigoid.~   "
52835|NCT02365571|"~     This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on~     the body. There will be 3 parts to this study.~      Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks~     for each participant. Each participant will receive two doses of LY3154207, if part A is~     completed.~      Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each~     participant. Part B includes collecting fluid from the spinal column to measure levels of~     LY3154207.~      Part C will include a single dose of LY3154207 given alone and then a second dose given~     along with itraconazole to look for change in LY3154207 levels. Part C will last about 3~     weeks for each participant.~      Participants may only enroll in 1 of the 3 parts of the study.~   "
52836|NCT02365558|"~     The purpose of this study is to evaluate the effect of increased stomach pH on how much~     evacetrapib is found in the blood stream and how long the body takes to get rid of it when~     given to healthy participants. Information about any side effects that may occur will also~     be collected.~      There are two parts to the study. Participation in both parts will be required.~      The study will last approximately 30 days, not including screening.~   "
52837|NCT02365532|"~     This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with~     dofetilide-induced QTc prolongation.~   "
52838|NCT02365519|"~     The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the~     reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when~     administered topically for up to 42 days, in subjects with severe dry eye disease.~   "
52839|NCT02365506|"~     This study will evaluate the effect of oral eleclazine (GS-6615) on QTc interval, safety,~     and tolerability in adults with long QT2 syndrome.~   "
52840|NCT02365493|"~     The aim of this clinical trial is to determine whether a novel combination antibiotic~     treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic~     treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant~     Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam~     antibiotics (these are antibitoics from the penicillin family) to the standard therapy will~     lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from~     the blood stream and other areas of infection, thereby reducing the risk of the spread of~     infection and death.~      The study design is an investigator-initiated, multi-centre, open-label, randomised~     controlled trial. This will include 440 participants diagnosed with Methicillin Resistant~     Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019)~     from within Infectious Diseases inpatient units across 21 hospital sites including 18 from~     within Australia and 3 located in Singapore. Participation will be voluntary and subject to~     informed consent. The participants will be randomised 1:1 to either the standard therapy~     group or combination therapy group. The combination therapy will include a treatment of~     intravenous beta-lactam for the first 7 days of treatment, in addition to the standard~     treatment (either vancomycin or daptomycin). The primary outcome measure will be~     complication-free survival 90 days post randomisation.~   "
52841|NCT02365480|"~     This randomized, pilot phase I trial studies the side effects of berberine chloride in~     treating patients with ulcerative colitis and who are in remission (a decrease in or~     disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer.~     Patients with ulcerative colitis are at increased risk for colorectal cancer.~     Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition~     from forming or coming back. The use of berberine chloride may keep colorectal cancer from~     forming in patients with ulcerative colitis.~   "
52842|NCT02365467|"~     The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA~     Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the~     device acutely and at the 30 day visit in the identified subject population. This study will~     also evaluate the current instructions for use and may direct changes to the delivery and~     deployment steps.~      The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona~     LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the~     device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B~     dissections.~   "
52843|NCT02365454|"~     A multicenter, prospective, open-label, non-randomized, interventional clinical study,~     sponsored by Endospan Ltd. Patients will be followed-up for five years.~   "
52844|NCT02365441|"~     An open label randomised trial for adults with histologically confirmed measurable~     metastatic GIST who have received no other treatment for metastatic disease. The study aims~     to determine if an alternating regimen of imatinib and regorafenib has sufficient activity~     and safety in comparison to imatinib alone to warrant further evaluation as a first line~     treatment for metastatic GIST.~   "
52845|NCT02365428|"~     Fewer pregnant women achieve recommendations for physical activity (PA) (30 minutes of~     moderate PA 5 days of the week) as compared to non-pregnant women (15.8% to 26.1%~     respectively), and PA participation declines as pregnancy progresses. The benefits of PA~     during pregnancy are abundant to both the mother (e.g., reduced weight gain, lower risk of~     gestational diabetes) and the fetus (e.g., decreased fat mass, improved stress tolerance).~     Pregnancy represents a significant time in a woman's life in which she may be motivated to~     change her health behaviors due to concerns for the healthy development of the fetus and a~     quick return to pre-pregnancy weight. Hence, pregnancy represents a critical time to support~     women in PA participation.~      In our previous research, 94% of pregnant and postpartum women of varying socioeconomic~     statuses reported using the Internet for pregnancy and PA information. Despite some women~     increasing their PA participation as a result, most did not know if a website was reputable~     or reliable (i.e. evidence-based). Studies have reported that most online health information~     is unregulated and inaccurate. Further, women often receive inadequate PA information from~     physicians who are constrained by time and lack of knowledge about PA. Therefore, directing~     pregnant women to evidence-based websites via text messaging may provide a feasible approach~     to improve PA participation. PA participation in pregnant women is an ongoing challenge that~     warrants testing of innovative solutions.~      The purpose of this study is to determine the feasibility of using mobile phone text~     messaging to refer pregnant women to evidence-based websites for PA information to increase~     PA levels.~   "
52846|NCT02365415|"~     This is a research study to assess whether an oral medication can benefit some patients~     being treated for peripheral pulmonary stenosis (PPS). PPS, which can be associated with~     several different congenital heart diseases, is narrowing of the blood vessels that send~     blood to the lungs (pulmonary arteries) to pick up oxygen before returning the blood to the~     heart and the rest of the body. The right ventricle (RV) is the pumping chamber that pumps~     blood into the pulmonary arteries and the lungs.~      PPS can result in high RV pressure, reduced blood flow to one lung, or uneven blood flow~     within either lung. If left untreated these abnormalities place affected children at risk~     for abnormal RV function and failure of this pumping chamber which may be seen as decreased~     ability to do exercise, heart rhythm problems, fainting, or even death.~      In the cardiac catheterization laboratory, the investigators treat PPS by dilating the~     narrowed segments of pulmonary arteries using balloon catheters. Sometimes the investigators~     also place stents which are mesh tubes that help keep the narrowed vessel open. Some stents~     suffer from in-growth of tissue into the stents which causes recurrent obstructions inside~     the stent (i.e. making the opening inside the mesh tube narrow again), so called in-stent~     stenosis (ISS). This effectively causes recurrent PPS and recurrence of the associated risks~     listed above.~      The purpose of this study is to use a medication that is approved for use in children (for a~     different purpose) to decrease the amount of cell ingrowth inside the stents (i.e. decrease~     the problematic in-stent stenosis). The medication is called rapamycin, also known as~     sirolimus (trade name Rapamune), and has been used safely for many years in children and~     adults after organ transplantation to prevent rejection of the new organ. It has~     antiproliferative properties which means that it slows down cell division which the~     investigators believe cause the recurrent narrowing inside stents. By slowing down the cell~     division the investigators believe that the stents will stay open instead of becoming~     narrowed inside again. This medicine is found in many types of stents placed in adults with~     narrowed arteries around the heart (so called drug-eluding stents) and appear to help keep~     these blood vessels open after heart attacks (or to prevent heart attacks). Such stents are~     currently not available for pulmonary arteries; therefore the investigators give the~     medicine by mouth instead (which has also been used in adults with stents in narrowed~     arteries around the heart).~      Rapamycin is a medicine that can be taken by mouth as a liquid or pill or via a feeding~     tube. There will still be a need for interventions in the catheterization laboratory but the~     investigators hope that by taking this medicine some children would need fewer~     catheterizations in the future. The investigators believe it may help lessen the risk of~     recurrent in-stent stenosis and the associated problems listed above. Our early experiences~     with a few patients at BCH who have been treated with rapamycin due to in-stent stenosis in~     the pulmonary arteries suggest that it may be helpful.~      In this study, patients and families who are interested in possibly trying this new approach~     will be randomized to sirolimus or no sirolimus. The investigators will compare the~     developement of ISS over time between these groups, in a hope to learn whether oral~     sirolimus reduces ISS development.~   "
52847|NCT02365402|"~     The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients~     obtain immune control to hepatitis B virus defined as sustained viral response after~     treatment. However this target could not be get if patients keep HBV DNA positive during~     interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir~     will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha~     2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of~     sustained viral response after 48 weeks of treatment and 24 week follow up.~   "
52848|NCT02365389|"~     A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the~     conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in~     the in-situ gel group as compared with 47.4 in the conventional gel group.The current study~     aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus~     twice-daily conventional MTZ vaginal gel in treatment of BV.~   "
52849|NCT02365376|"~     The objective of this protocol is to enable collection of biospecimens to facilitate current~     and future multidisciplinary research in rare genetic disorders and medical conditions.~   "
52850|NCT02365363|"~     The objectives are to test the acute effects of different bagels containing pulse~     ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of~     blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two~     hours following the exercise session. We hypothesize that consumption of bagels containing~     pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen~     consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a~     reduction in lactate production during compared to the same exercise session following the~     ingestion of a non-pulse food. We also hypothesize that consumption of bagels containing~     pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake,~     suggesting lower calorie compensation, following a 60-minute aerobic exercise session~     compared to the same exercise session following the ingestion of a non-pulse food.~   "
52851|NCT02365350|"~     The primary objective is to demonstrate superiority of follicle flushing with the~     STEINER-TAN Needle® as compared to single lumen aspiration in terms of numbers of COCs~     retrieved.~   "
52852|NCT02365337|"~     The aim of this study is observing the relation between serum Vitamin D levels and~     morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women~     undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor~     infertility. Individuals will be divided into 2 groups according to serum vitamin D levels~     as normal or low , and the influence of those levels in morphokinetic parameters of embryos~     will be identified.~   "
52853|NCT02365324|"~     The proposed integrated project will evaluate the effects of an evidence-based extension~     education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory~     and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of~     delivery on balancing calories to manage body weight (BW), reducing certain foods and food~     components, increasing selected foods and nutrients, building healthy eating patterns [i.e.,~     fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT~     variables. Briefly, the 12-week program will target early adolescent children, ages 11-14~     years, test a peer-education approach to behavioral change and will be delivered as an~     after-school program in local middle schools in support of childhood obesity prevention.~     Data will be collected at baseline (preintervention), after the 12-week program~     (post-intervention) and 6 months after completion of the program (maintenance).~   "
52854|NCT02365311|"~     The investigators used transesophageal echocardiography (TEE) to assess the change of~     pulmonary blood flow and bi-ventricular function during lung isolation. The investigators~     hypothesized that changes in pulmonary venous flow with lung isolation may be related the~     shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also~     observed the cardiac function during two lung ventilation (TLV) and OLV in supine and~     lateral position by TEE.~   "
52855|NCT02365298|"~     In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel~     materials and that this protein remains largely active and promotes reduced cytokine~     response in an in vitro culture of human corneal epithelial cells. This study investigates~     whether these data transfer to the in vivo situation.~   "
52856|NCT02365285|"~     The investigators will test the hypothesis that acute central acetylcholinesterase~     inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.~   "
52857|NCT02365272|"~     The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients~     with severe sepsis and septic shock.~   "
52858|NCT02365259|"~     The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on~     vitamin D production in persons with MS.~   "
52859|NCT02365246|"~     Removal of IgE through adsorption of IgE on a specially designed column after apheresis of~     blood has the potential to improve the severity of atopic dermatitis.~      In this study the investigators will treat patients with a severe form of Atopic dermatitis~     not responding or having to much side effects to systemic imunosuppressive treatment with~     this modality.~   "
52860|NCT02365233|"~     The primary objective of this trial is to measure changes in hepatic lipid content using~     three common alternative therapeutic strategies to improve glycemic control in patients with~     type 2 diabetes who are not controlled with metformin alone.~   "
52861|NCT02365220|"~     The purpose of this study is to investigate the placebo effect in a smartphone-based~     training, ostensibly designed to improve mood and perceived stress by daily exposition to~     either mock sound or color.~   "
52862|NCT02365207|"~     Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment~     response) BCG intravesically followed by a cystectomy.~   "
52863|NCT02365194|"~     A pre-operative physical conditioning and weight loss intervention (prehabilitation)~     compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40~     kg/m2) at a safety-net hospital results in a higher proportion of patients being hernia- and~     complication-free 2 years after surgical consultation.~   "
53145|NCT02361489|"~     The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or~     basal insulin with oral agents can be efficiently and safely started with meal time insulin~     using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go)~     using one of two dose titration algorithms to achieve improved A1C at 4 months.~   "
52864|NCT02365181|"~     The control of perioperative pain is necessary to avoid worst surgical suites after shoulder~     arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in~     postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse~     events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter~     is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in~     shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early~     postoperative analgesia after shoulder arthroplasty.~   "
52865|NCT02365168|"~     Study hypothesis:~      Some children and adolescents with fish allergy can tolerate eating some species of fish~      Purpose of the study:~      The purpose of this study is to determine to which degree fish allergic children and~     adolescents can tolerate some species of fish and find the minimal eliciting allergen dose~     to which only 10% of participants get allergic reaction.~      Participants:~      Participants are 40 patients recruited from children and adolescents outpatient clinics at~     the University Hospital of North Norway with a history of fish allergy and sensibilisation~     of one or more fish species with either positive specific IgE in serum or skin prick test.~     Patients with sensibilisation to one or more fish species that never have eaten fish are~     also recruited.~      Method:~        -  All participants undergo a clinical examination including lung function test with~          spirometry before inclusion in the study.~        -  All participants are tested for allergic sensibilisation with measure of specific IgE~          against common food and inhalation allergens in addition to 10 different fish species.~        -  All participants are challenged with cod, salmon, mackerel and placebo, disguised in a~          chocolate mousse. The challenges are performed in randomized order with Double Blind~          Placebo Controlled Food Challenge (DBPCFC) on 4 different challenge days with minimum 6~          weeks in between each challenge day.~        -  Participant with allergy to pollen will not be challenged during pollen season.~        -  Test food is developed especially to this study in cooperation with The National~          Institute of Food Research in Norway and The University of Manchester. The National~          Institute of Food Research in Norway have produced a dried powder of cod, salmon and~          mackerel. The Molecular Allergology group at Manchester Institute of Biotechnology,~          the University of Manchester, have produced test kits based on chocolate mousse~          containing low and high doses of the fish powders. The National Institute of Food~          Research have measured protein content and microbiology in the fish powders. The~          Molecular Allergology group have provided quality measurements of the final product and~          tested the disguise in a sensoric test panel.~        -  Participants with no allergic reaction to one or more of the blinded challenges undergo~          open food challenge with larger doses of cooked fish than used in the DBPCFC, after the~          randomization has been broken.~   "
52866|NCT02365155|"~     There is enough scientific evidence of the benefits detection of frailty in patients with~     heart failure, which is an important prognostic factor. The usefulness of screening frailty~     as flattering tool making diagnostic and therapeutic decisions in patients with heart~     failure and now emerges in various recent studies. However, it is not found in the~     literature any study on the potential effectiveness of a comprehensive intervention on the~     fragility that includes the physical section (endurance, strength, flexibility and balance),~     nutritional, hormonal (supplementation deficit D vitamin) and pharmacological (adjusted to~     clinical guidelines according to requirements) in patients with heart failure after~     hospitalization for cardiac decompensation, to improve survival and reduce cardiac~     decompensation and hospital admissions resulting in a better quality of life for these~     patients. Therefore, the investigators designed the following study.~   "
52867|NCT02365142|"~     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)~     of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet~     richa plasma (PRGF) in patients with knee osteoarthritis.~      Patients and methods~      Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19~     patients for each group. The investigators compare the intraarticular injection of against~     the administration of two different doses of mesenchymal stem cells with hialuronic acid~     according to the following scheme:~        1. Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7~          days.~        2. Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7~          days and one with Mesenchimal stems cells. Intra-articular injection of 100 million~          autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension~          sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection )~          followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment~          is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one~          week.~      In addition the investigators assess the response to intra-articular infusion of CMM~     analyzing the following parameters:~        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since~          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.~        -  Radiographic (baseline and 12 months from treatment): Femorotibial space.~        -  Radiographic using MRI (baseline and 12 months from treatment): by assessing the number~          location of the lesions , cartilage thickness , signal intensity , subchondral bone~          alteration , volume and WORMS and dGEMRIC protocols.~   "
52868|NCT02365129|"~     The energy burning capacity of brown adipose tissue makes it an attractive target for~     anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown~     adipose tissue; however, recent findings show a pool of novel brown adipose tissue~     activators that sidestep the need for stimulating the SNS, including cardiac natriuretic~     peptides. Of interest is that both SNS and non-SNS brown adipose tissue activators are~     sensitive to physical exercise, which opens new horizons and opportunities to study the~     potential effect of exercise-based therapeutic interventions. Moreover, a new protein~     released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the~     browning program of white adipose tissue. Most of the available evidence comes from animal~     studies, which is sometimes difficult to infer to human physiology. The overall objective of~     the ACTIBATE randomized controlled trial is to study the effect of long-term exercise~     training (6 months) on brown adipose tissue activity and quantity (primary outcomes) in~     young overweight and obese adults. The clinical significance of activating and recruiting~     brown adipose tissue on resting metabolic rate and cardiometabolic profile in humans will be~     determined. The investigators will also study at the molecular level the benefits of~     exercise on the regulation pathways in two different tissues: white adipose tissue and~     skeletal muscle, as well as identifying possible cross-talk between the exercising muscle~     and heart, and fat. Information from exercise-induced signaling on brown adipose tissue,~     white adipose tissue and skeletal muscle will help on identifying potential molecular~     therapeutic candidates.~   "
52895|NCT02364778|"~     This is a prospective study to analyze the outcome of provisional main vessel stenting on~     side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain~     optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional~     main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of~     side branch impingement of the ostium of SB leading to acute loss in SB diameter area,~     carina shift and plaque shift will be also be performed.~   "
52896|NCT02364765|"~     The purpose of the present study was to compare some hematologic parameters and operation~     time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.~   "
52869|NCT02365116|"~     Every year in the United States about 1 million people make a suicide attempt and more than~     38,000 die by suicide. The risk of suicide is highest among individuals with mental illness~     who have been hospitalized due to suicidal thoughts or behaviors, yet there are few~     interventions known to reduce suicide risk in this population. This study will develop and~     pilot test a peer mentorship intervention by which trained peer professionals will use their~     own personal experience with recovery from mental illness to instill hope and belongingness~     in high-risk patients and provide additional support to prevent future suicidal thoughts or~     behaviors.~      The specific aims of the study are to: (1) develop a peer mentorship intervention to reduce~     suicide risk among patients psychiatrically hospitalized with suicidal ideation or following~     a suicide attempt; (2) Conduct a randomized controlled pilot study to assess the~     acceptability, feasibility, and fidelity of the peer mentorship intervention in preparation~     for a larger efficacy trial; and (3) an exploratory aim will be to measure potential~     mediators and moderators of intervention effectiveness in terms of belongingness,~     burdensomeness, and hopelessness according to the interpersonal theory of suicide.~   "
52870|NCT02365103|"~     The purpose of this study is to investigate the inhibition effect of tea consumption on non~     haem iron absorption with the use of an iron tracer. The study also aims to assess the~     effect of time variability of tea consumption on non haem iron absorption from a typical~     western breakfast.~   "
52871|NCT02365090|"~     1. To determine whether a binocular iPad game app is effective in improving visual acuity~          and reducing interocular suppression in amblyopic children~        2. To compare the amount of visual acuity improvement achieved with the binocular game app~          to the amount achieved with patching (standard treatment for amblyopia)~   "
52872|NCT02365077|"~     This is a observation clinical trial. We are collecting the patients with glucocorticoid.~     They were divided into the experiment group (with femur head necrosis) and control group~     (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide~     association study (GWAS). Our purpose is to find susceptibility loci for~     glucocorticoid-induced femur head necrosis in the Chinese population.~   "
52873|NCT02365064|"~     The study will determine which of two different types of positive airway pressure (PAP~     therapy) modes are more effective in reducing sleep breathing events in chronic insomnia~     patients and in decreasing insomnia severity.~   "
52874|NCT02365051|"~     This community-based translational trial tests the value of a proven non-pharmacologic~     intervention for older adults living with dementia and informal caregivers when this~     intervention is incorporated into a publicly-funded home and community based service~     program. Half the participants will receive customary publicly-funded services alone, and~     half will receive customary services plus the proven non-pharmacologic intervention.~   "
52875|NCT02365038|"~     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a~     driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical~     Network strategy (conventional strategy) in patients with acute respiratory distress~     syndrome (ARDS).~   "
52876|NCT02365025|"~     Amongst adolescents, there is a gap that widens with age between recommended sleep duration~     and actual sleep time. Due to this gap, bodily and mental functions such as those related to~     the metabolic and immune systems, performance, memory, school achievement and creative~     ability can be harmed. Moreover, lack of sleep involves an increased risk of accidents and~     injuries, behavior problems and reduced quality of life.~      Biological factors that explain changes in sleep patterns include delays in the circadian~     timing system and in the homeostatic system that regulate sleep and wakefulness. These~     changes cause a growing and continuous delay in sleep phase during adolescence. In addition,~     a number of environmental factors affect sleep patterns: variables such as early school~     start time, increased homework assignments, after-school activities, lack of parental demand~     for adequate sleep hours, and increased screen time, or use of electronic media, including~     television, computer games, internet and cellular phones.~      Based on the Parental Style model, the authoritative parenting style is characterized by~     parents setting high demands on their children on the one hand and displaying high levels of~     responsiveness to their children on the other. The authoritarian parenting style is~     characterized by parents setting high demands on their children on the one hand yet~     displaying low levels of responsiveness to their children on the other. The permissive~     parenting style is characterized by parents setting low demands on their children and~     displaying high levels of responsiveness to their children. In several investigations, the~     authoritative parenting style has been shown to have a positive influence on child~     development, academic achievement and psychosocial competency, and promoted healthy~     behaviors in adolescents, such as good eating habits, increased physical activity and a~     decrease in risky behaviors such as smoking, alcohol abuse, extreme diets and early sexual~     behavior.~      The Conceptual Model views parents as the sole agents of change in their children's life,~     and focuses on the power of personal example, environmental changes and promotion of the~     authoritative parental style. The main aim of this research is to evaluate the effectiveness~     of an intervention program that deals with increasing parents' awareness of the changes that~     characterize adolescents and encourages the authoritative parental style based on the~     Parenting Style Model.~   "
52877|NCT02365012|"~     This study will evaluate whether treatment with the α1-agonist, midodrine, reduces~     subjective orthostatic lightheadedness as measured by the Non-Motor Symptoms Scale for~     Parkinson's Disease (NMSS) questionnaire, in patients with (positive control group, OH) or~     without documented orthostatic hypotension(orthostatic intolerance, OI). It will also~     demonstrate the effect of treatment with an α1-agonist, midodrine, on beat-to-beat blood~     pressure and heart rate response during Valsalva maneuver (measured by Continuous~     Non-invasive Arterial Pressure, CNAP) in patients with OI or OH and evaluate the~     relationship to symptom improvement.~   "
52878|NCT02364999|"~     This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial~     evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin~     versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients~     with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.~   "
52892|NCT02364817|"~     Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD)~     was frequent among patients with alcohol-dependence. However, no investigation has ever~     addressed whether ADHD may impact the drinking outcome.~      Moreover, most of the different aforementioned studies assessed ADHD using the ADHD~     self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited~     diagnostic value, and the overrepresentation of high-score ASRS among patients with~     alcohol-dependence could be in part due to differential diagnoses such as antisocial or~     borderline personality disorders, executive function impairments, or isolated impulsiveness.~      The study aims to evaluate ADHD: Gaps between patients with Alcohol Dependence and Impact~     on early Relapse (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the~     end of a residential detoxification program. They are assessed for ADHD using the ASRS, but~     also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults~     (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The~     patients are followed-up during the 12 first post-detox weeks, through a standardized~     psychosocial treatment. ASRS is re-performed at the end of the follow-up.~   "
52879|NCT02364986|"~     There are two standard and a few second line treatments for RRMS. Since the disease cannot~     be cured by these existing treatments and all treatment options have significant~     limitations, there is the need to develop new treatment strategies to improve therapy of~     patients with RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients~     with MS. The RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but~     has advantages over therapy with recombinant IFN-b. Identification of suitable biomarkers to~     monitor treatment with RIG-I ligand and to guide the dose steps would help to increase the~     safety of the volunteers in the early clinical trials with RIG-I ligand.~      The RESI study is designed to analyse immune readouts and potential biomarkers such as type~     I IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or~     Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three~     times a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1~     and 8), as they are routinely used in RRMS-therapy. The immune readouts are assessed on day~     1, 3, 5 and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 /~     12 /24 hrs after Rebif/Avonex application by analysing blood samples. Since studies of the~     RIG-I ligand will start in healthy volunteers and will be continued in MS patients we need~     data from both populations since they could show significant differences in response to~     IFN-b. Thus, the RESI study includes healthy volunteers, RRMS-patients already under~     Rebif/Avonex treatment, and RRMS-patients who have to yet started a therapy with~     Rebif/Avonex.~   "
52880|NCT02364973|"~     The main purpose of the present study is to examine the diagnostic performance of combined~     PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by~     ulcerative colitis and Crohn's disease.~   "
52881|NCT02364960|"~     The purpose of this study is to create a registry to evaluate the use of intra-operative~     radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given~     intra-operatively as a single fraction after breast conserving surgery,~   "
52882|NCT02364947|"~     The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in~     patients with alcohol dependence will be evaluated in a multicenter, randomized,~     double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of~     nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of~     alcohol consumption.~   "
52883|NCT02364934|"~     To explore and compare the effects of propoful, sevoflurane, and a combination of both on~     the pharmacokinetics and pharmacodynamics of rocuronium.~      To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of~     rocuronium.~      To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of~     rocuronium.~   "
52884|NCT02364921|"~     The purpose of this study is to evaluate the effectiveness of a multilayer compression~     bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in~     patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.~   "
52885|NCT02364908|"~     This study is a biomedical, open label, therapeutic strategy, interventional,~     non-randomized, multicenter study to evaluate the non compliance to antimalarials in~     patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in~     two visits. These visits consist in obtaining blood sample, performing a clinical~     examination and filling in a questionnaire (Quality Of Life, Coping...).~      The goal for the noncompliants patients is to guide them towards the therapeutic education~     with professionals (nurses and physicians).~   "
52886|NCT02364895|"~     This study evaluates effectiveness of mailed invitations for colorectal cancer screening~     among screen-eligible Ontarians who are due for screening. The study will evaluate the~     effectiveness of mailed invitations in general (compared to no invitation) but will also~     determine if new invitation letters (2 letters for male, 1 letter for females) are more~     effective than current invitation letters used by the ColonCancerCheck program.~   "
52887|NCT02364882|"~     This is a Phase 1, single center, open-label, within-subject dose-escalation study~     evaluating the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women.~     Three dose levels of SST-6006 and a placebo regimen will be evaluated: 1 g (0 mg of~     sildenafil), 1 g (50 mg of sildenafil), 2 g (100 mg of sildenafil), and 4 g (200 mg of~     sildenafil). Doses will be administered sequentially and will be separated by a 14-16 day~     washout period. All 3 dose levels and the placebo will be applied both externally and~     internally.~   "
52888|NCT02364869|"~     This 12-week double-blind randomized controlled clinical trial aims to investigate the~     effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic~     toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and~     the impact of such intervention on cardiovascular markers, intestinal permeability,~     endotoxemia and inflammatory response.~   "
52889|NCT02364856|"~     This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and~     its variations after painful stimulations in children with cerebral palsy : acute procedural~     pain (botulinum toxin injections), and recurrent pain (physiotherapy).~   "
52890|NCT02364843|"~     This is the 5th in a series of physiological studies to determine the amino acid~     requirements of infants. There have been 4 studies to determine tyrosine, methionine,~     threonine and lysine requirements in infants when they are fed by parenterally~     (intravenously). Due to the new requirements of Health Canada for preparation of parenteral~     solutions, the investigators are starting the phase of the study that determines the enteral~     (oral) intake of threonine in 1 - 6 mo infants in the interim.~   "
52891|NCT02364830|"~     Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but~     Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of~     Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and~     bloating.~   "
52893|NCT02364804|"~     The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon~     the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer~     (NSCLC).~   "
52894|NCT02364791|"~     The purpose of this study is to explore whether the addition of Hemopatch to standard care~     can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in~     thoracic lung surgery patients at high risk for prolonged air leaks.~   "
53188|NCT02360930|"~     The trial is to determine if a difference exists in the way that adolescents and young~     adults metabolize the chemotherapy agent vincristine compared to younger children.~   "
52897|NCT02364752|"~     The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other~     circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels~     in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and~     other circulating biomarker levels, and performs imaging in participants with cardiac~     dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy~     participants, biomarker levels are elevated in participants with mild/moderate and severe~     cardiac dysfunction.~   "
52898|NCT02364739|"~     Fertility knowledge and awareness is considered insufficient in women of reproductive age~     from developed countries. The objective of this study is to evaluate if educational~     interventions in oocyte donors increase on their level of fertility knowledge and awareness.~   "
52899|NCT02364726|"~     The purpose of this study is to find out the effects of acupuncture on reducing nerve~     damage.~      Acupuncture is a medical technique of inserting very thin needles into the energy points~     on the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and joint pain. In this study the investigators will assess if~     acupuncture can be used to ease the pain, tingling and numbness that may be caused by~     chemotherapy and improve quality of life during chemotherapy.~   "
52900|NCT02364713|"~     This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal~     sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in~     treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has~     been changed in a certain way, may be able to kill tumor cells without damaging normal~     cells.~   "
52901|NCT02364700|"~     This is an interventional pilot study investigating the feasibility of using the hand of~     hope (HOH) device for individuals with decreased hand function after stroke.~   "
52902|NCT02364687|"~     Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart~     conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time~     consuming, contraindicated for some patients and not tolerated by others. Computed~     tomography (CT) imaging has the potential to provide a rapid comprehensive assessment of the~     heart. This study will assess CT imaging of the heart muscle of patients who have previously~     undergone MRI of their heart. Using a state of the art CT scanner the investigators will~     develop a low radiation dose protocol to identify scarred heart muscle. The investigators~     will use and develop software techniques to analyse these images. This will enable us to~     develop a new way to identify and measure scarred heart muscle that will benefit patients~     with heart disease.~   "
52903|NCT02364674|"~     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early~     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust~     and automated segmentation algorithms will be developed for these parameters, focusing on~     quantitative computed tomography (CT) image analyses to provide the physician a more~     sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid~     image registration methods.~   "
52904|NCT02364661|"~     Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus~     infects the liver and previous studies, done in tissue culture and in animals, have shown~     that viral replication is affected by metabolic changes occurring in the liver.~     Specifically, starvation induces HBV gene expression and replication, in parallel to the~     activation of the gluconeogenesis response, and feeding attenuates viral activity. In this~     study we are going to recruit HBV patients with detectable viremia and analyze their viral~     load after an over night starvation versus after a morning meal. Our hypothesis is that~     following an over-night starvation viral load will be higher than that in the fed state.~   "
52905|NCT02364648|"~     The purpose of this study is to examine the effect of mitochondria derived oxidative stress~     on vascular function in patients with moderate to severe Chronic Kidney Disease.~   "
52906|NCT02364635|"~     PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose,~     Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects~      Objective:~        -  To assess the safety and tolerability of single ascending oral doses of icosabutate in~          healthy subjects~        -  To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects~   "
52907|NCT02364622|"~     The purpose of this study is to determine whether using the flexible Trachway(R) intubating~     stylet could facilitate and promote the accurate placement of double-lumen endobronchial~     tube.~   "
52908|NCT02364609|"~     This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given~     together with afatinib dimaleate in treating patients with non-small cell lung cancer that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be~     an effective treatment for non-small cell lung cancer.~   "
52909|NCT02364596|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single~     vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy~     adults aged 18 to <65 years.~   "
52918|NCT02364479|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein~     injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary~     purpose is to assess the different maintaining treatment programme in SpA patients with~     controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and~     safety of Yisaipu® in axial SpAs. The trial will include 180 patients with stable NSAIDs~     therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the~     second stage the patients who achieve low disease activity (LDA, ASDAS<2.1) at 24th week~     will be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of~     Yisaipu® group and placebo group. And the blind stage will last for 24 weeks. Patients who~     complete the 48-week therapy or achieve disease-flare criteria during the blind stage would~     finish the study.~   "
52919|NCT02364466|"~     Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to~     investigate the complication including febrile neutropenia in the era of pegylated G-CSF~     prophylaxis.~   "
52910|NCT02364583|"~     This study specifically seeks to provide data on the safety, tolerability and pilot efficacy~     of short course, high dose primaquine treatment in Papua New Guinean children aged 5-10~     years, in a cross-sectional study design. Community screened asymptomatic cases and/or cases~     of clinically diagnosed malaria admitted to the out-patient units of the health center, will~     be screened for Glucose-6-phosphate dehydrogenase deficiency (G6PD) and malaria illness by~     rapid diagnostic test and P. vivax infection confirmed by light microscopy. Following~     treatment with artemether-lumefantrine (Coartem), G6PD normal children will be enrolled into~     the study and followed for 2 months. Primaquine treatment will be allocated to study~     participants in a step-wise design; firstly receiving the current 14 day treatment regimen~     of 0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose~     of 1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5~     days, should the 7 day treatment prove to be safe and well tolerated. In addition to this~     dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0~     mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years.~     The pharmacokinetic profiles obtained by this sub-study will be essential for modeling the~     population pharmacokinetic data obtained from the dose-escalation study. As there is~     currently no data on the safety, tolerability and efficacy of primaquine in children, the~     present study will validate previous observation and contribute to the knowledge of~     primaquine as a treatment for liver stages of Plasmodium vivax infection.~   "
52911|NCT02364570|"~     Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer~     of adults in the United States. Our work is aimed at understanding how short-term increases~     in blood sugar, like those that accompany eating a meal, affect blood vessel function and~     the risk of CVD. This research is aimed at understanding how meals composed of eggs affect~     short-term increases in blood sugar from eating, which are connected with increased risk of~     CVD. In particular, the investigators are trying to identify a specific meal composed of~     either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood~     sugar brought on by meals that consist of majority carbohydrate. At the same time, the~     investigators are trying to explore the protective affects that eggs may have on blood~     vessel function and the reduction of CVD risk.~   "
52912|NCT02364557|"~     This randomized phase II/III trial studies how well standard of care therapy with~     stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy~     alone in treating patients with breast cancer that has spread to one or two locations in the~     body (limited metastatic) that are previously untreated. Standard of care therapy comprising~     chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of~     tumor cells. Radiation therapy and/or surgery is usually only given with standard of care~     therapy to relieve pain; however, in patients with limited metastatic breast cancer,~     stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to~     send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be~     able to effectively remove the metastatic tumor cells. It is not yet known whether standard~     of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating~     limited metastatic breast cancer.~   "
52913|NCT02364544|"~     The goal of the Improving Care and Reducing Cost (ICRC) Program, is to improve disease~     management and the overall process of care in treating the chronic illness schizophrenia in~     order to reduce ER visits and hospital days while providing better care, better health and~     increased patient satisfaction. This will be done by fostering innovation in the use of~     technology and by training and deploying a new cadre of personnel in the behavioral health~     field: Mental Health/Health Technology (MH/HT) Case Managers.~   "
52914|NCT02364531|"~     The purpose of this study is to temporally evaluate the impact of abiraterone acetate~     (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the~     chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population. Safety~     data, levels of health care resource utilization associated with abiraterone acetate~     (ZYTIGA) therapy will also be prospectively collected and analyzed.~   "
52915|NCT02364518|"~     The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a~     suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for~     the treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty~     (QSS) is a procedure where the suture will be inserted into the soft palate tissues for the~     treatment of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in~     the back of the roof of the mouth.~      The research results will be used to provide data on feasibility (strengths and weaknesses),~     safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy~     for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the~     U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of~     surgery that involved deep tissues in the body.~      The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie~     receive financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the~     only place that this study will be conducted. For this research study the investigators plan~     to enroll a total of up to 20 subjects at the Medical University of South Carolina.~   "
52916|NCT02364505|"~     The aim of the project is to investigate the impact of a multiple sclerosis specific~     telemedicine mindfulness-based Intervention on the quality of life of people with multiple~     sclerosis and their caregivers.~   "
52917|NCT02364492|"~     The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained~     following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses~     of 30 µg, 100 µg or 300 µg IM every three weeks.~   "
52957|NCT02363959|"~     The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     airway complications in post-lung transplant recipients with evidence of restricted levels~     of blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage~     in the early post-transplant period will be randomized to HBOT or usual care and followed~     clinically for 12 months following randomization. The investigators hypothesize that HBOT~     will decrease the number of airway complications in the treated subjects.~   "
53310|NCT02359344|"~     A randomized, double-blind, placebo controlled, two period crossover study to investigate~     the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in~     healthy young versus elderly male and female subjects. Treatment periods will be separated~     by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.~   "
52920|NCT02364453|"~     The purpose of this study is to determine the effects of antihistamine (Clemastin) on~     migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well~     as on biochemical markers for mast cell degranulation in migraine patients. Also, to~     investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in~     lower dosages than previously investigated. As this has never been done before it is unknown~     how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the~     accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine~     attacks.~      Our three hypotheses are:~        1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of~          migraine in migraine patients.~        2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and~          tryptase after PACAP38-infusion.~        3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine~          patients.~   "
52921|NCT02364440|"~     Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands.~     Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained~     pre-treatment and at 90 days post-treatment~   "
52922|NCT02364427|"~     Acute Kidney Injury is a condition where your kidneys suddenly stop working properly and~     usually occurs if you are already unwell with an illness and can happen after having~     surgery. Having an episode of acute kidney injury increases the risk of progression to~     chronic kidney disease (CKD) later on and decreases long-term survival. It also has a major~     socioeconomic impact with regards to admissions and length of hospital stay. There is~     currently no universally accepted treatment or method of identifying patients that are at~     risk. The investigators aim to measure arterial stiffness in patients prior to them~     undergoing cardiac surgery to investigate whether this measurement is associated with an~     increased risk of patients developing acute kidney injury after surgery. The investigators~     are planning to measure arterial stiffness, and examine a blood sample, for kidney~     health-related levels to determine whether there is an association between those patients~     who have stiff arterial vessels and those patients who may develop acute kidney injury after~     surgery.~   "
52923|NCT02364414|"~     The purpose of this study is to compare the accuracy of measurements derived from a~     commercially available direct intra-oral scanning system with those taken from plaster study~     models, and to compare cost implications of both systems.~      The investigators will test the hypotheses:~        -  There is no systematic difference between measurements taken from the Trios scanner and~          study models.~        -  There is no difference in the cost of producing digital models.~   "
52924|NCT02364401|"~     The purpose of this study is to compare the efficacy of catheter ablation for atrial~     fibrillation between contact force-guided and impedance-guided annotation using automated~     annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly~     assigned in the same number to two groups with impedance guided ablation and contact force~     guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter,~     Biosense Webster, Inc., Diamond Bar, CA).~   "
52925|NCT02364388|"~     Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to~     concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and~     B-mode imaging). This medical device has CE-marking and is approved for use in Europe and~     other nations.~      This is a post-market, non-randomized multi-center surveillance study.~   "
52926|NCT02364362|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      This study assessed the safety and maximum tolerated dose of continuous daily treatment with~     Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous~     and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II~     trial.~   "
52927|NCT02364349|"~     This double-blinded randomized clinical trial investigates any differences in allergic~     responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).~   "
52928|NCT02364336|"~     Background:~      - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but~     the virus can be controlled with the use of antiviral medicines,. Researchers think that~     adding a second antiviral medicine might help.~      Objective:~      - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to~     see if peginterferon is safe to use with other antiviral medications.~      Eligibility:~      - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral~     medicines for hepatitis B for at least 4 years.~      Design:~        -  Participants will be screened with physical exam and medical history. They will~          complete health questionnaires about their levels of fatigue and pain. They will have~          blood and urine tests. They may have an eye exam.~        -  Participants also will have a Fibroscan. A test to measure how stiff your liver is.~        -  Eligible participants will have a liver biopsy. Blood will be drawn.~        -  Participants will be admitted to the NIH Clinical Center. They will be injected with~          the study drug. Then they will have a second liver biopsy. They will be discharged 24~          hours later.~        -  Participants will give themselves study drug injections under the skin weekly for 24~          weeks.~        -  Participants will have 5 clinic visits during the 24-week treatment period. Then they~          will have follow-up visits every 12 weeks for 48 weeks.~        -  During visits, participants may have a physical exam and medical history. They may have~          blood and urine tests. They may have a Fibroscan and complete questionnaires. At the~          final visit, they will also have a Fibroscan.~   "
52958|NCT02363946|"~     The purpose of the study is to determine the safety and tolerability of escalating doses of~     ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on~     circulating levels of alpha-1 antitrypsin. The study will consist of two parts, Part A~     (conducted in healthy volunteers) and Part B (conducted in AATD patients) at up to 9~     escalating dose levels with 6 participants per dose level.~   "
53094|NCT02362152|"~     This non-interventional, multinational study of topical field treatment of actinic keratosis~     (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other~     topical field therapies commonly used in the individual country. Physicians will report~     baseline characteristics, while the main study focus will be on patient reported outcomes~     3-4 weeks after treatment completion (treatment satisfaction, adherence, resource~     utilization and Health Related Quality of Life.~      Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and~     Canada will participate.~   "
52929|NCT02364323|"~     The risk of diabetic kidney complications includes non-modifiable risk factors such as~     genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension,~     hyperlipidaemia and proteinuria. Genetic testing for personalized medicine is increasing in~     popularity, though evidence that genetic testing can empower patients to modify behaviour~     and reduce clinical risk remains lacking. In this project, the investigators aim to utilize~     a personalized risk counseling with genetic testing to evaluate its impact on risk factor~     control in diabetic patients. The investigators hypothesize that knowledge of genetic +/-~     clinical risk will empower patients and lead to improvement in the number of treatment~     targets achieved. The investigators will recruit 400 patients with diabetes. All subjects~     will undergo a comprehensive assessment of the risk of diabetic complications based on~     clinical risk factors. Half of the patients will be randomized to receive additional genetic~     testing of a panel of genetic markers proven to predict renal complications in our~     population: ACE I/D, aldose reductase (CA)n and PRKCB1 gene polymorphisms. The results of~     personalized risk assessment will be communicated by a health counsellor in the intervention~     arm. The impact of testing and patient knowledge of the result of genetic testing on~     achievement of treatment targets (A1c, BP, LDL-cholesterol, TG, use of ACEI/ARB) and patient~     behavior will be evaluated after 12 months. The other arm will receive results of the~     genetic testing at the completion of the study period. The study will help towards~     developing a strategy to empower patients through structured and personalized risk~     assessment will provide a novel approach to identify high-risk subjects for early intensive~     management, and may lead to reduction in long-term complications.~   "
52930|NCT02364310|"~     Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation~     with Barostim NeoTM compared to usual care in patients with resistant hypertension~     (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long~     modeling.~   "
52931|NCT02364297|"~     In the last years, important advances have been done in the treatment and prevention of~     fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of~     pharmacological and endoscopic therapy (with tissue adhesives) should be the first line~     therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2~     gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic~     shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent~     variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy~     and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in~     esophageal variceal bleeding showed that an early TIPS, performed during the first 72h after~     patient admission resulted in a significant decrease in failure to control bleeding and~     early and late rebleeding. Moreover, survival was also significantly increased as well as~     other portal-hypertension related complications (ascites, spontaneous bacterial peritonitis,~     hepatorenal syndrome, etc).~      The present study is directed at comparing the outcome of patients with acute bleeding from~     fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic~     injection of tissue adhesives) with or without early TIPS (performed during the first 1-5~     days after admission). Main end-point will be survival free of variceal rebleeding at 1 year~     from inclusion.~   "
52932|NCT02364284|"~     Reporting patterns and results of initial antibiotic treatment in patients with complicated~     urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial~     pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study~   "
52933|NCT02364271|"~     The investigators hypothesize that coronary artery calcium score (CACS), heart-type fatty~     acid binding protein (H-FABP) concentration, high-sensitive troponin t (hs-cTnT)~     concentration and Thrombolysis in Myocardial Infarction (TIMI) score positively correlate~     with the rate of the major adverse cardiac events (MACE) at 30 days and 6 months in patients~     presenting to the ED with suspected acute coronary syndrome (ACS).~      The aims of the present study in patients with chest pain of uncertain cardiac cause and a~     non-ischaemic initial electrocardiogram (ECG) presenting to the ED are~        1. To investigate whether there is any correlation between CACS, H-FABP concentration,~          hs-cTnT concentration and modified TIMI score with the MACE rate at 30 days and 6~          months;~        2. To evaluate the predictive values of CACS, H-FABP, hs-cTnT, modified TIMI score and~          various combinations.~      Study design and participants This prospective observational study was conducted in the~     Prince of Wales Hospital in Hong Kong.~      Chest pain adult patients suspected with acute coronary syndrome were recruited.~     Point-of-care H-FABP and hs-cTnT tests, TIMI score and CT scan for coronary calcium score~     were performed on study subjects. Patients were followed-up at 30-day and 6 months for the~     occurrence of major adverse cardiac events.~      In 2014, a modified HEART score incorporating hs-cTnT was included as one of the predictors~     under study alongside with modified TIMI score, FABP and CACS. The HEART score was completed~     retrospectively.~   "
52934|NCT02364258|"~     This will be a single center, open label, randomized, cross-over study in patients with~     dyslipidemia comparing the pharmacokinetics of rosuvastatin and atorvastatin in patients~     with greater than or equal to one variant allele in the SLCO1B1 gene (-11187 and/or c.521)~     to patients with the wild-type/wild-type genotype.~      The studies goal is to establish the role of genetic variation and development in key~     transporters on the dose-exposure relationship of two commonly used statin drugs in~     children. This study is the first step in a series of investigations aimed to determining~     the mechanisms behind variations in physiologic response, clinical efficacy and significant~     adverse effect risk that surround the statin drugs in children and adolescents.~   "
52935|NCT02364245|"~     The purpose of this study is to design and evaluation the feasibility, effects of~     Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral~     Palsy.~   "
52936|NCT02364232|"~     The purpose of this study was to compare the treatment effects of home-based or clinic-based~     bilateral training with and without mirror feedback programon on physiological markers,~     sensorimotor, cognition, daily functions, and participation among patients with chronic~     stroke.~   "
52937|NCT02364219|"~     The primary purpose of this study is to determine whether a prewarming period of at least 30~     minutes during induction of general and combined epidural anesthesia reduces the core~     temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal~     surgery. In addition the effect of prewarming on intra and postoperative body core~     temperature will be evaluated.~   "
52938|NCT02364206|"~     Glioblastomas are extremely resistant to treatment, including radiotherapy and/or~     chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways~     involved in the regulation of normal cell proliferation, survival and differentiation.~     Activation of p38 MAPK has been associated with a poor prognosis among patients with~     glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by~     tumor cell to environmental stress such as radiation or chemotherapy.~      LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of~     its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good~     candidate to target malignant glioma resistance to the gold standard treatment combining~     radiation and TMZ by acting on both tumor and stromal cells.~      The primary objectives of this study were to determine the recommended dose of LY2228820 in~     combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to~     estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820~     when administered at the recommended dose in combination with radiotherapy and concomitant~     TMZ (phase II)~   "
52939|NCT02364193|"~     Heart failure (HF) is a major health problem, which is characterized by reduced cardiac~     function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned~     hospitalization are due to pulmonary congestion. There is an urgent clinical need for~     quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic~     fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging~     (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the~     investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus~     kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).~      Primary objectives: This study evaluates the correlation between change in BIS and change in~     bolus kinetic parameters in response to a fluid challenge.~      Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges~     and the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.~      Study design: Prospective nonrandomized pilot study.~      Study population: Healthy volunteers.~      Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI~     contrast agent. External pressure will be applied by means of a leg-compression device in~     order to induce a rapid increase of the preload by blood auto-transfusion.~      Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution~     curve which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV),~     changes in bolus kinetic parameters, and thoracic impedance in response to fluid challenges.~     The correlation between changes in bolus kinetic parameters and thoracic impedance in~     response to fluid challenges.~   "
52940|NCT02364180|"~     The investigators are intending to enroll Patients who are chronically treated with~     pyridostigmine for the treatment of any medical condition and presenting at the~     investigators' outpatient clinics for follow up appointment. Subjects taking pyridostigmine~     for the treatment of myasthenia gravis will be excluded. Both adults and children older than~     12 years of age will be approached. Those subjects that agree to participate will be asked~     to sign an informed consent. For the participation of minors a parental (or guardian)~     consent and subject assent will be obtained. Those that participate will answer a few~     questions pertaining to their medical history and will then undergo electromyograph (CMAP)~     measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the~     accessory nerve in the neck). Evoked electromyogram will be recorded on a computer hard~     drive. Eight percent or greater decrement in the CMAP response on repetitive stimulation~     will be considered positive.~   "
52941|NCT02364167|"~     The study entitled Acupuncture vs. placebo acupuncture and vs. standard therapy for pain~     control after elective caesarian section - a randomized controlled trial aims to~     investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic~     requirement as compared to placebo and standard therapy in patients after after elective~     caesarian section (CS) in the period from January 2015 to May 2016.~      For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia~     will be recruited according to eligibility criteria. 120 patients will be randomized either~     to verum or placebo acupuncture, 60 patients will be included in non-randomized standard~     therapy arm. The outcome measures are: postoperative analgesic requirement, pain intensity,~     incidence of side effects and physiological parameters.~   "
52942|NCT02364154|"~     The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to~     (i) discriminate between colorectal cancer patients and control subjects and (ii) identify~     new biomarkers for colorectal cancer. In order to test this hypothesis, the investigators~     will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic~     phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects.~     Multivariate statistics will be performed to assess the discriminative power of the applied~     methodology in distinguishing between both groups and to identify metabolites with potential~     as biomarkers for colorectal cancer.~   "
52943|NCT02364141|"~     The aim of this study was to evaluate the long-term effects of the task-specific training~     with trunk restraint comparing to the free one in post-stroke reaching movements. Twenty~     hemiparetic chronic stroke patients were selected and randomized into two training groups:~     Trunk restraint group - TRG (reaching training with trunk restraint) and Trunk free group -~     TFG (unrestraint reaching). Twenty sessions with forty-five minutes of training were~     accomplished. The subjects were evaluated in pre-treatment (PRE), post-treatment (POST) and~     three months after the completed training (RET). The measures administered were the Modified~     Ashworth Scale, Barthel Index, Fugl-Meyer Scale and kinematic analysis (movement trajectory,~     velocity, angles).~   "
52977|NCT02363686|"~     The purpose of this study is to learn more about problems with swallowing that could develop~     in patients who are very sick and need a machine to help them breathe.~   "
52979|NCT02363660|"~     1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine~          in women given low doses of vaccine by the ID route with the NFI (Group III) to those~          women given standard doses by the IM route with a needle and syringe (Group I) at 1~          month, 6 months and 18 months following completion of the vaccination series.~        2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine~          in women given standard doses of vaccine by the IM route with the NFI (Group II) to~          those women given standard doses by the IM route with a needle and syringe (Group I) at~          1 month, 6 months and 18 months following completion of the vaccination series.~   "
52944|NCT02364128|"~     At least 15 million Americans are morbidly obese, or more than 100 pounds overweight.~     Medical treatments including drugs and behavior modification have proven ineffective in~     producing significant and lasting weight loss in this group. While bariatric surgery is~     extremely effective for most patients, it also carries risks for both short and long-term~     complications. There are currently four different types of bariatric surgery available and~     the risks and benefits of these procedures vary widely and are strongly affected by patient~     and clinical characteristics.~      Decision making under these circumstances should reflect informed patient's values and~     preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more~     often driven by the beliefs and experiences of the bariatric surgeon that a patient happens~     to see. Variability in the type of surgery recommended to patients likely results from some~     combination of surgeons' subjective opinions and personal experiences with regard to the~     risks and benefits of the treatment options and delegated decision making on the part of~     patients.~      The goals of this research proposal are to develop, implement, and evaluate an informed~     decision support tool for treatment of morbid obesity. This project will be conducted within~     the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide~     clinical registry and quality improvement program that has the participation of virtually~     every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes~     externally audited clinical data for more than 35,000 consecutive bariatric surgery~     patients. MBSC outcome measures include complications occurring within 30 days as well as~     weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years~     after bariatric surgery.~   "
52945|NCT02364115|"~     The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy~     in patients with bone metastatic disease.~   "
52946|NCT02364102|"~     The investigators aim to study whether hypothyroidism negatively affects Brown adipose~     tissue (BAT) function in humans and whether BAT function can be restored to normal by~     thyroid hormone supplementation.~   "
52947|NCT02364089|"~     The general objective is to evaluate the consequences of surgical removal of SCSI on~     hypertension and cardiovascular risk factors in order to determine on an evidence-based~     basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients~     with hypertension.~   "
52948|NCT02364076|"~     This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior~     systemic therapy. All subjects will receive MK-3475 treatment intravenously once every three~     weeks until unacceptable toxicity, death, progressive disease or withdrawal.~   "
52949|NCT02364063|"~     This study evaluates the effectiveness of a voiding reeducation program as treatment for~     incontinence in children with a brain injury.~   "
52950|NCT02364050|"~     Prospective data collection of a consecutive series of elderly patients with large B-cell~     lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric~     Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of~     Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).~   "
52951|NCT02364037|"~     The investigators study is testing models of contraceptive care that were developed as part~     of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women~     designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which~     include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to~     contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4)~     reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that~     interventions such as comprehensive contraceptive counseling, increased access, and removal~     of financial barriers increase the uptake of LARC methods and reduce unintended pregnancy.~     The investigators objective is to determine whether the CHOICE model of contraceptive care~     can be equally successful in the real world of community clinics.~   "
52952|NCT02364024|"~     The purpose of this study is to confirm that linear quantification of CD3+ cells is a~     prognostic biomarker in localized colorectal carcinomas.~   "
52953|NCT02364011|"~     The purpose of this investigation is to determine both patient-reported and~     performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes,~     between four different surgical total knee prostheses in individuals following TKA. Change~     scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee~     extension strength/power, static/dynamic balance control, mobility measures and functional~     performance testing during functional tasks (i.e. walking, ascending/descending stairs,~     sit-to-stand). After evaluating the pattern of change in lower-extremity function, the~     investigators will be better prepared to address residual functional impairments and~     prognostic factors linked to maximal recovery over two years.~   "
52954|NCT02363998|"~     The purpose of this Phase 3 open-label treatment study is to evaluate the safety and~     effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute~     withdrawal from any opioid, including methadone and buprenorphine. This study will take~     place in a variety of clinical scenarios, both in-clinic and outpatient settings.~   "
52955|NCT02363985|"~     The combination of infectious diseases and malnutrition is the most prevalent, preventable~     public health problem in the world, responsible for millions of deaths annually,~     particularly in infants and children. Approximately 13 million children die each year in~     developing countries from infectious diseases, with the majority of these deaths related to~     malnutrition. The relationship between infections and malnutrition is synergistic, each~     further compromising the outcome of the other. Malnutrition compromises natural immunity~     leading to increased susceptibility to infections, more frequent and prolonged disease~     episodes, and increased severity of disease. Likewise, infections can aggravate or~     precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption,~     nutrient loss or increased metabolic needs. Another issue is that infections (as well as~     overweight and obesity status) affect nutritional biomarkers making it difficult to assess~     the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A~     deficiency is defined to be of severe public health importance if 20% or more of a defined~     population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating~     concentrations of serum retinol are reduced by infections and in such situations serum~     retinol concentration is not a good indicator of vitamin A status. Serum acute-phase~     proteins can indicate the severity and duration of an infection. Correcting vitamin A~     deficiency is addressed in Ethiopia through vitamin A supplementation of children, dietary~     diversity and using bio-fortified foods. However, assessing vitamin A status, and the~     effectiveness of government interventions, is challenging in settings where infectious~     diseases are endemic, as in most area of the country. Evaluation of vitamin A status is~     relatively insensitive when based on changes in serum retinol concentrations, which are~     homeostatically controlled and negatively affected by subclinical infections. Liver stores~     of vitamin A, the best indicator of vitamin A status, cannot be routinely evaluated. The~     isotope dilution technique is the preferred method for determining vitamin A status and~     assessing the efficacy and effectiveness of intervention programs aimed at improving vitamin~     A status. It is the only indirect assessment method that provides a quantitative estimate of~     vitamin A status across the continuum of deficient to excessive stores.~   "
52956|NCT02363972|"~     A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a~     less invasive means of establishing vascular access to facilitate dialysis in patients with~     end stage renal disease.~   "
53026|NCT02363049|"~     The present study is a multicentric randomized phase III trial designed to assess whether~     overall survival and quality of life are improved in patients with asymptomatic colon cancer~     and unresectable SLM treated with resection of the PT followed by chemotherapy versus~     chemotherapy alone.~   "
53027|NCT02363036|"~     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance~     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the~     host immune response are similar to those used by the developing placenta during normal~     pregnancy. In addition to the shared capacity for invading through normal tissues, both~     cancer cells and cells of the developing placenta create a microenvironment supportive of~     both immunologic privilege and angiogenesis.~      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that~     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived~     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow~     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells~     have been shown to play an essential role in mediating immune suppression in animal models~     of human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been~     found in peripheral blood, lymphoid organs and the tumor tissue itself. An increased~     population of IMCs was identified in patients with several tumor types. Accordingly, IMCs~     detected in the peripheral blood of such patients bearing express the common myeloid marker~     CD33 but lack markers of mature myeloid cells such as the MHC class II molecule HLADR.~      IMCs have been shown to actively promote tumor growth and metastasis by modulating the~     cytokine environment, and through vascular remodeling by promoting angiogenesis.~      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice~     and actively promote angiogenesis. These cells show striking similarity to IMCs that~     populate malignant tumors. Accordingly, human placentas are also infiltrated by a~     significant population of IMCs. Immunostaining of human placentas showed that IMCs comprise~     around 25% ( range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells~     and that this population is located close to blood capillaries. We also demonstrated that~     immature DCs, cells originally described to regulate the adaptive immune response, also~     promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors.~      This is a retrospective study on patient's blood samples of pregnant women who came to~     delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes~     and neutrophils in: 1. Term active labor. 2. Elective cesarean section.~      According to our previous findings, we hypothesize that monocytes in active delivery will be~     lower than in women without signs for labor. We also hypothesize that neutrophils will be~     more abundant in active delivery than in women without signs for labor.~      We plan to screen anonymous electronic data of women who delivered in our departement during~     2014 according to the following eligible criteria, stratified into 2 categories: 1. Women~     who were admitted in active labor. 2. Women who were admitted for elective Cesarean Section~     without signs of labor.~      We will compare the abundance of monocytes and neutrophils in blood counts that were taken~     on admission day between the two populations.~   "
52959|NCT02363933|"~     This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive~     anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory~     partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this~     study, patients will be started on a dose of 2 mg of perampanel daily taken orally at~     bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg~     increments per week up to 8mg daily, as long as it is well tolerated by the patient. The~     highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients~     will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is~     8mg, but the dose can be modified by the physician based on patient reported tolerability.~     Titration and taper periods will be determined by the physician in the case where patients~     do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the~     Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8~     weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination~     (H&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of~     seizure history, patient-reported outcomes of QoL, and computer based neurocognitive~     testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17,~     patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they~     will no longer take perampanel. Patients will be considered off treatment at the end of week~     20, once perampanel has cleared their system. Patients will then be monitored through Week~     24. Patients will continue to take their original AED regimen after they stop perampanel. If~     seizure control is achieved during the maintenance period or if seizures occur during the~     tapering period, patients can be continued on perampanel per the discretion of the treating~     physician. In this instance, perampanel will be prescribed by the treating physician and not~     provided within the confines of the study. Efficacy will be assessed using a log of~     patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch~     Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures~     that occur. Research team members will regularly contact patients for reminders and reports~     from the log. Safety will be assessed with the following laboratory evaluations: complete~     blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity~     assessment.~   "
52960|NCT02363920|"~     Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in~     hypoxic patients and ameliorate breathing pattern in hypercapnic patients.~      The aim of this study is to better understand the physiological mechanism underlying these~     results, assessing the respiratory mechanics in stable hypercapnic COPD patients.~   "
52961|NCT02363907|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4~     System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to~     17 years-old with diabetes mellitus.~   "
52962|NCT02363894|"~     The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to~     assess and estimate the long term effect of treating a vessel with plaque excision (PE) in~     combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with~     PTX PTA alone.~   "
52963|NCT02363868|"~     The purpose of this study is to examine the healthcare costs among patients with CML~     receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured~     population.~   "
52964|NCT02363855|"~     The primary objectives of this study are to investigate the safety and tolerability of BAY~     1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC)~     and the PK of BAY 1841788 and its major metabolite BAY 1896953.~   "
52965|NCT02363842|"~     The study is a multi-center, prospective, randomized, controlled, clinical study evaluating~     the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially~     available pressure redistribution surfaces compared to standard of care (SOC). The objective~     of this study is to evaluate if a commercially available pressure redistribution surface~     when combined with the Skin IQ™ MCM coverlet will significantly reduce pressure ulcer (PU)~     incidence as compared to use of a commercially available pressure redistribution surface by~     itself by decreasing the effects of excessive moisture and temperature at the skin and~     surface interface.~   "
52966|NCT02363829|"~     Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical~     carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV~     cisplatin in combination as radiosensitizers with daily whole pelvic external beam and~     intracavitary radiation brachytherapy.~   "
52967|NCT02363816|"~     Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are~     strongly linked and predict the risk of further complications and early death in adulthood.~     The newer antipsychotics, called the second generation antipsychotics are commonly used to~     treat mood disorders in adult and pediatric populations. Their use has substantially~     increased (up to 5-fold) in the past 15 years in children due to their approved use by the~     Food and Drug Administration and higher acceptance in the general medical community.~     However, second generation antipsychotics are known to have very damaging side effects that~     cause children to gain substantial amounts of weight, have high cholesterol, high blood~     pressure and high sugar levels. Despite the known risks their use is still needed and may be~     contributing to the high rates of obesity-related diseases in childhood and ultimately~     shorter life-spans in adulthood. How second generation antipsychotics cause these side~     effects is still not well known. Preliminary evidence has identified a novel pathway that~     may be associated with second generation antipsychotic side effects. This pathway has not~     been studied, is involved in vitamin A metabolism and is called the beta-carotene pathway.~     Beta-carotene is an important part of our diet because it acts as an anti-oxidant (fights~     harmful oxidative stress in the body) and it produces the active form of vitamin A which is~     essential for several processes in our body. The investigator's work has identified a backup~     in this pathway which the investigators hypothesize is due to genetic variation of the~     enzymes found within this pathway.~      The investigators hypothesize that genetic variation in the beta-carotene pathway is~     responsible for the side effects associated with second generation antipsychotics. The~     investigators want to complete a cross-sectional, pilot study in the pediatric population~     that will be used for future prospective, extramural applications.~      The investigators propose two aims for this study:~      Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For~     this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be~     due to genetic varition in the beta-carotene pathway.~      Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second~     generation antipsychotic induced insulin resistance. For this aim the investigators~     hypothesize that low beta-carotene levels will be associated with high oxidative stress~     levels and insulin resistance.~   "
52968|NCT02363803|"~     Diabetic nerve pain [painful diabetic peripheral neuropathy] is a common medical problem~     with few reliably effective treatments. There is some evidence that sensory testing may help~     determine how individuals will respond to analgesic therapy. In this study, the~     investigators are evaluating the relationship between sensory testing and subject response~     to lidocaine infusion therapy.~   "
52969|NCT02363790|"~     This study is comparing the outcomes patients undergoing LVHR, PFC as opposed to a bridged~     repair with assessment of patient reported satisfaction and function at 6 months of~     follow-up.~   "
52978|NCT02363673|"~     The aim of this study is to determine the effect of individualised homoeopathic treatment of~     children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design,~     with a structured interview and quantitative measurement components taking place over 12~     weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are~     invited to participate and their parent/guardian is required to be present during each~     consultation. Each consultation will consist of a homoeopathic case taking, conduction of~     the Childhood Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC)~     measures and a brief physical exam. After each consultation, the participant will receive an~     individualised homoeopathic remedy, according to their individual symptoms and~     characteristics, to take for the subsequent 4 weeks. This remedy will be determined using~     the Mercurius® repertory software.~   "
59558|NCT02277613|"~     This is a double-blind, sham-controlled clinical study to evaluate the safety and~     feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST~     elevation MI).~   "
52970|NCT02363777|"~     Design: Level I randomized prospective outcomes study comparing two groups of patients. One~     group will receive 0.2% ropivacaine plus 5 mcg/mL dilaudid thoracic epidural analgesia (PCA)~     post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks~     with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine~     post-operatively and a PCA.~      Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients~     presenting to the University of Minnesota Medical Center for elective open pancreatic~     surgery.~      Primary Objective: To determine if bilateral paravertebral catheters in patients with open~     pancreatic procedures result in decreased pain compared to patients treated with thoracic~     epidural for post-operative pain.~      Secondary Objectives:~        1. To determine whether the use of bilateral paravertebral catheters impacts the length of~          ICU and hospital stay for patients, compared to a thoracic epidurals in patients~          undergoing elective open pancreatic surgery.~        2. To determine whether the use of ultrasound guided bilateral paravertebral catheters~          leads to lower risk of complications, compared to use of a thoracic epidural in~          patients undergoing open pancreatic surgery.~   "
52971|NCT02363764|"~     Accurate identification of lower respiratory tract pathogens is standard of care in the~     management of CF patients and it is therefore recommended to perform regular bacterial~     cultures, at least once a year, but some even recommend monthly cultures. This can be done~     through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold~     standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore,~     the diagnosis of lower respiratory tract infections can be challenging in the~     non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and~     nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies~     have investigated the reliability of these different sampling methods, however, with~     controversial conclusions.~   "
52972|NCT02363751|"~     Open-label, non-randomized, multicenter, phase II, single arm non comparative trial~     evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with~     bevacizumab in first-line setting in metastatic collecting duct carcinoma.~   "
52973|NCT02363738|"~     Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar~     Disorders (BD). Increased levels of circulating proteins known as cytokines that promote~     inflammation have been consistently reported in individuals with bipolar disorders. A~     particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those~     cytokines that have been consistently identified across depressive, manic, and euthymic~     periods. Disturbances in inflammation however, are not seen in all individual with bipolar~     disorder. Those individuals with signs of inflammation also often present with higher~     prevalence of medical disorders that are also associated with inflammation. Those~     individuals with significant signs of inflammation may respond to anti-inflammatory~     treatments. In this study, individuals with bipolar depression who exhibit signs of high~     inflammation will be enrolled and treated with either an anti-inflammatory biologic known as~     infliximab or placebo (saline).~   "
52974|NCT02363725|"~     Background:~      Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.~      More recnetly it is regularly use in the treatment of pericarditis. It couls exert~     antiiflammatory effects targeting the adverse inflammation occuring incase of acute~     myocardial infarction, which is involved in poor outcomes or longer stay at hospital.~      Endpoints:~        -  Main endpoint: AUC CRP during the initial hospital stay~        -  Secondary endpoints:~             -  Clinical: oucomes~             -  Imaging: ETT, MRI~             -  Biological: various biomarkers~      Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal~     optimal treatment versus conventionnal optimal treatment + colchicine~   "
52975|NCT02363712|"~     Painful knee osteoarthritis is common and treatments, short of knee replacement, are~     limited. The investigators plan to test the efficacy of a novel promising device for~     treatment of knee osteoarthritis affecting the inner part of the knee, the most common~     location. There are no disease modifying treatments available and therefore there is an~     emphasis on conservative management techniques to benefit individuals. Many of these~     treatments (insoles, braces, physiotherapy etc) have been shown to have relative success in~     individuals but a new novel device is demonstrating better effectiveness in this patient~     group. APOS (All Phases of Step) therapy consists of a shoe oriented system of care that~     works by shifting the load across parts of the knee and retraining the lower extremity~     muscles. Preliminary data suggest impressive favourable reductions in knee pain and a~     commensurate decrease in knee loading during walking. However, APOS treatment has never been~     evaluated in a randomised controlled trial even though it is widely used among Bupa members~     and in other parts of the world. In addition, no study has fully investigated the mechanism~     in which this treatment is aiding knee pain, whether it is primarily a biomechanical~     (mechanics of movement) alteration, a muscle strength and control change, or a combination~     of the two. The investigators propose to conduct a randomised blinded controlled trial of~     APOS treatment among persons with painful knee osteoarthritis affecting the inside (medial~     or lateral) of their knees. The investigators will focus on pain outcomes and quality of~     life but to better understand how and in whom APOS treatment is working, the investigators~     will also obtain data on loading across the knee in the gait laboratory, along with measures~     of strength and function. In addition to the standard pain scales, changes in knee structure~     on treatment using MRI (Magnetic Resonance Imaging) will be analysed to determine whether~     bone marrow lesions (bone bruises) are reduced as these are strongly linked with pain in~     individuals with medial or lateral knee osteoarthritis, and are related to loading of the~     medial or lateral knee. APOS has committed to provide the shoe system and a matched sham~     device, that they have developed, and will also provide the technicians trained to calibrate~     the pertupods (balls under the sole of the foot) on the shoe without charge. The research~     will be undertaken in a University setting for the gait evaluations which has strong links~     with the Wellcome Trust Clinical Research Facility in Manchester for the MRI imaging.~     Running a randomised controlled trial is very labour and time intensive and therefore the~     team assembled has vast experience of carrying out randomised controlled trials of other~     treatments in knee osteoarthritis, and is experienced in both ethical requirements,~     recruitment and evaluation. The costs requested reflect the nature of this research with a~     large proportion on staff costs and also non-staff costs for the MRI imaging and other~     non-staff costs.~   "
52976|NCT02363699|"~     Ineffective treatment of postoperative pain may cause organic damage and chronic pain.~     Nevertheless, opioids, the leading drugs used for this purpose, present side effects that~     sometimes restrict their usability. In a multimodal context, new postoperative analgesia~     techniques have been developed focusing in the reduction of opioid use and their adverse~     effects, as well as postoperative chronic pain prevention. In this background, continuous~     intravenous infusion of lidocaine during perioperative period has shown to be promising.~     This trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus~     and length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients~     undergoing to laparoscopic cholecystectomies who received intravenous lidocaine in~     comparison to a control group. Intravenous lidocaine in the perioperative period of~     laparoscopic cholecystectomies was not able to reduce postoperative pain, opioid~     consumption, and duration of ileus or length of hospital stay. However, its~     anti-inflammatory effect was evidenced by the significant changes in the studied cytokines.~   "
52980|NCT02363647|"~     Medullary thyroid cancer (MTC) is an uncommon thyroid malignancy comprising of up to 5% of~     all thyroid cancers. The National Cancer Institute (NCI) estimates that 56,460 Americans~     will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. Early~     disease is usually only confined to the thyroid and can be cured with surgery.~     Unfortunately, more than 50% of cases are diagnosed with locally advanced or metastatic~     disease, and a 10-year survival for them is about 40%. In most tumors, as well as in MTC,~     single-agent inhibitor therapy has faced numerous problems and has often provided patients~     with only limited benefits. In this study, the investigators will be using the results of a~     previous study in which the Drosophila animal model combined with extensive pretesting~     genetic analysis of samples taken from patients' individual tumors was used to potentially~     develop personalized therapeutic plans for those enrolled. In this study, the investigators~     will offer to treat those patients with their personalized therapeutic plan (if they were~     able to develop one in the prior study).~      This is a therapeutic clinical trial in which the investigators will provide personalized~     therapy to patients with medullary thyroid cancer based on a Personalized Therapeutic Plan~     (PTP) developed under the separate Tumor Genomic Analysis and Molecular Testing for~     Personalized Cancer Therapy protocol (GCO# 14-0054 (0001) MSSM). This therapeutic protocol~     applies only to the treatment period of Personalized Medicine. The objective is to establish~     superiority of Personalized Medicine in terms of efficacy (Overall Response Rate) in MTC~     patients, or substantially similar efficacy but with reduced toxicity, when compared to the~     best standard of care option for recurrent/metastatic MTC (currently cabozantinib) as was~     demonstrated in a phase III trial.~   "
52981|NCT02363634|"~     A randomized double blind placebo controlled trial to evaluate the effects of a specialized~     magnesium on mood states and sleep quality in older adults.~   "
52982|NCT02363621|"~     This study is designed to compare the post injection inflammation and pain seen after~     intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.~      The investigators will be evaluating patients (1-7 days) post injections for:~      1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as~     measured on a standardized pain scale).~   "
52983|NCT02363608|"~     The purpose of this study is to describe the effects of canine-assisted activity visits on~     patients and staff in a hospital setting. The Caring Canines program uses dogs who have been~     trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the~     dog's handler) and the volunteer's dog that has been trained and tested to have a good~     personality and to follow commands. A visit typically lasts about 10-15 minutes with the~     patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan~     Kettering currently has Caring Canine dogs visit patients but the investigators don't yet~     know the impact of these visits on patients and staff. The investigators would like to see~     how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense~     of well-being. Two groups of patients will take part in this study - the first group will~     receive standard post surgery care and will not receive a visit from the Caring Canines~     program and the second group will receive daily visits (Tuesday -Friday) from the Caring~     Canines program while they are on M15. The purpose of this study is to look at differences~     in well-being between patients who have the visits with the dogs and patients who do not.~   "
52984|NCT02363595|"~     The purpose of this study is to identify specific clinical and molecular characteristics~     that are predictive of tumor progression in small thyroid cancers.~   "
52985|NCT02363582|"~     Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot~     of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that~     both prebiotics and lactoferrin play important roles in generating a~     bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the~     stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a~     starting infant formula supplemented with prebiotics and lactoferrin.~   "
52986|NCT02363569|"~     This is a prospective study, where the investigators will monitor pregnant women at 4-23~     weeks of pregnancy coming to the Women- E.R. at Meir Hospital due to spontaneous -or~     after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires~     regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo~     full examination including ultrasound. After discharge, the investigators will recommend to~     all the women who came due to bleeding or bleeding secretions to avoid intercourse for two~     weeks after the bleeding stops. Afterwards they will be monitored until their delivery date~     (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy).~     After they give birth the investigators will assess the rate of pregnancy, obstetric and~     embryonic complications in each of the study groups.~   "
52987|NCT02363556|"~     This randomized controlled trial will use a 2 by 2 factorial design to assess methods of~     cervical preparation prior to Dilation and Evacuations (D&Es) at 14 0/7 to 19 6/7 weeks~     gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with~     misoprostol and separately randomized to buccal or vaginal administration of 400-mcg~     misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40~     buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal~     and 40 buccal). Four to six hours later, the Dilation and Evacuation (D&E) procedure will be~     performed.~   "
52988|NCT02363543|"~     The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as~     effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive~     concurrent treatments with both products on their first and/or second degree burns located~     on both hands.~   "
52989|NCT02363530|"~     This randomized controlled subject- and examiner-masked study comprised patients scheduled~     for cataract surgery.The patients will be randomly assigned to receive either balanced salt~     solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject~     should undertake examination including - rupture time (TBUT), height of the river of tears,~     fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and~     self-conscious symptom assessment questionnaire for assessment.~   "
52990|NCT02363517|"~     This study will investigate the feasibility of treating people who inject drugs (PWID) with~     hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy~     combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a~     social network-based approach to reduce HCV incidence among PWID.~   "
53028|NCT02363023|"~     The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic~     bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic~     bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator~     associated pneumonia and their impact in morbimortality.~   "
56176|NCT02321813|"~     The purpose of the study is to determine whether a quality of life pathway with defined~     diagnostic and therapeutic options improves quality of life in colorectal cancer patients~     during follow-up.~   "
52991|NCT02363504|"~     The cause of Alzheimer's disease, the most common form of dementia, remains unknown.~     Neuropathological studies suggest that a small area in the brainstem, the locus coeruleus,~     might be the site of the onset of the disease. This area is the sole source of noradrenalin~     to the brain, a neurotransmitter involved in arousal, but also cognitive functions. Animal~     and pharmacological studies have hinted towards an important role of this area in memory~     functioning. However, these studies were hampered by the limited spatial resolution, making~     it hard to clearly localize the locus coeruleus in the brain. New developments in brain~     imaging allow now to visualize the brain with stunning precision. Furthermore, a~     non-invasive new stimulation method, transcutaneous vagus nerve stimulation, is believed to~     excite the locus coeruleus and thereby influencing neuronal networks and memory functioning.~      There are three aims in this project:~        1. To investigate how the functional interaction between the locus coeruleus and other~          brain areas, in particular the medial temporal lobe areas, during memory processes~          (encoding, consolidation and retrieval) change with development of Alzheimer's disease.~        2. To investigate associations between noradrenaline, memory performance and brain~          functioning. The investigators aim to investigate how acute noradrenalin levels change~          during the different memory processes and whether or not this is beneficial for~          performance. Furthermore, the investigators will investigate whether this interaction~          between noradrenalin, memory performance and brain functioning is different healthy~          older individuals (n =35) or patients with prodromal Alzheimer's disease (n =35).~        3. To investigate the underlying neural network changes during transcutaneous vagus nerve~          stimulation. The investigators will focus on differences in functional connectivity~          between the locus coeruleus and the medial temporal lobe areas in healthy older~          individuals and prodromal Alzheimer's disease patients. An experimental condition will~          be compared with a sham condition in a pseudo-randomized cross-over design.~   "
52992|NCT02363491|"~     The dose-confirming part of this study, comprising at least 10 patients is designed as a~     single center, prospective, single arm, open label in patients who have failed or are~     unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an~     Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with an additional~     30 patients; the objective of the whole study being to assess the safety, efficacy,~     pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in~     low and intermediate-1 risk myelodysplastic syndrome (Second line Lower risk MDS).~   "
52993|NCT02363478|"~     Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is~     compromised in about 75% of patients. Previous studies have shown that buspirone, an orally~     available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy~     volunteers. Recently, the investigators observed that a single dose of buspirone (10mg)~     improves lower esophageal sphincter (LES) function in patients with SSc and esophageal~     involvement .~      Objectives: To evaluate the effect of continuous administration of buspirone on esophageal~     dysfunction and related symptoms in SSc using high resolution manometry (HRM).~   "
52994|NCT02363465|"~     To optimize a medical device for intradermal injection, knowledge concerning the thickness~     of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is~     lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults~     using imaging technology (High Frequency Ultrasound). The investigators hypothesize that~     they are able to correlate the thickness of the (epi)dermis to a specific combination of~     parameters age, gender, and BMI.~      Based on these results, the investigators can define which needle type and length is needed~     to correctly perform injections into the dermal layer.~   "
52995|NCT02363452|"~     The purpose of this study is to determine if treatment with reverse transcriptase inhibitors~     returns the interferon signature observed in patients with AGS to normal levels.~   "
52996|NCT02363439|"~     An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.~   "
52997|NCT02363426|"~     The purpose of this study is to evaluate intravaginal culture using the medical device~     INVOcell to generate day 5 blastocysts in comparison to traditional IVF.~   "
52998|NCT02363413|"~     The study is based on the assumption that in the Overlap Syndrome, the introduction at home~     of the NIV is as effective in terms of compliance and clinical and gazometric improvement,~     and life quality, that setting hospital start up. The investigators will study the~     initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient~     groups. The main objective of the study is to demonstrate the non-inferiority of the~     initiation of the NIV at home versus hospital in terms of compliance.~   "
52999|NCT02363400|"~     Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus~     (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China~     and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high~     incidence of lymphatic and hematological dissemination. Because of the inherent anatomic~     constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary~     treatment for NPC patients.~      NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been~     used to treat NPC patients with advanced-stage diseases during recent 20 years. However,~     treatment outcome for locoregionally advanced NPC is still unsatisfactory.~   "
53000|NCT02363387|"~     The investigators propose to evaluate a novel incentive intervention to promote suppression~     of viral load in people living with HIV that will employ empirically-based parameters that~     have been proven critical to the effectiveness of incentive interventions. Participants (N =~     200) from medical clinics that serve adults living with HIV in Baltimore will be randomly~     assigned to an Incentive or a Usual Care Control group. Incentive group participants will~     receive incentives for maintaining suppressed and undetectable viral loads. The incentive~     program will employ high magnitude incentives, provide incentives for decreases in viral~     load early in treatment before a patient's viral load has reached undetectable levels,~     arrange frequent incentives early in treatment and reduce the frequency of incentives as~     participants achieve progressively longer periods of viral load suppression, arrange a~     schedule of escalating incentives for sustained suppression of viral load, and the~     intervention will be maintained for two years. Usual Care Control participants will only~     receive the standard HIV medical care offered in their clinic. Assessments will be conducted~     every 3 months throughout the two years of treatment and every 6 months throughout the year~     following treatment. The primary outcome measure will be the percentage of participants that~     have undetectable viral loads at the 3-month assessments conducted throughout the 2-year~     intervention period. Secondary measures will include adherence to HIV care and~     post-treatment outcomes. The investigators will also assess moderators and mediators of the~     effects of the incentives on the suppression of viral load, and conduct cost-effectiveness~     and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and~     is economically sound, it could be used to improve the health of adults living with HIV,~     reduce health care costs, and reduce HIV transmission in the community.~   "
53029|NCT02363010|"~     The major goal of this project is to evaluate an innovative approach to obesity. This study~     will determine if behavioral treatment can be improved by 1) implementing a primary focus on~     PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach~     to the promotion of PA.~   "
53030|NCT02362997|"~     This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using~     the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation~     therapy after autologous stem cell transplant (ASCT), in patients with relapsed or~     refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or~     peripheral T-cell lymphoma (PTCL) in 1st remission.~   "
53031|NCT02362984|"~     This is a prospective, randomized, double-blind, and controlled clinical study to~     investigate the effects of DLBS1033 in conjunction with standard therapy compared to~     standard therapy alone in acute ischemic stroke patients.~   "
53001|NCT02363374|"~     Preoperative 5-FU-based (5-fluorouracil) chemoradiotherapy (CRT), total mesorectal excision~     surgery, and 4 cycles of adjuvant 5-FU - as established by CAO/ARO/AIO-94 - is at present a~     standard of care for patients with locally advanced rectal cancer (UICC stage II and III).~     The phase III German CAO/ARO/AIO-04 trial showed, that the addition of oxaliplatin increased~     treatment efficacy in terms of early secondary efficacy endpoints (e.g. the pCR-rate). With~     a median follow-up of 50 months, the primary endpoint of this trial - disease free survival~     - was significantly improved in the oxaliplatin-containing treatment arm (3-year~     disease-free survival (DFS) 71.2% versus 75.9%, hazard ratio (HR) 0.79, 95% confidence~     interval (CI) 0.64-0.98, p=0.03). The hereby proposed randomized phase II trial~     CAO/ARO/AIO-12 aims at finding novel and innovative aspects of rectal cancer treatment, and~     will thus provide important information for defining the experimental arm in the upcoming~     large scale trial of the group. Compared to the current standard, in both study arms, the~     sequence of the three treatment modalities is modified, placing the chemotherapy block~     before surgery. The pre-operative sequence of chemotherapy -> chemoradiotherapy (arm A) has~     been shown to be feasible with no early tumor progression prior to definitive surgical~     resection in a small randomized phase II study from Spain. The sequence chemoradiotherapy ->~     chemotherapy (arm B) may be beneficial according to response kinetics considerations, and by~     maintaining a highly effective local treatment in the first place. Both approaches could~     avoid the problem of major compliance problems with post-operative adjuvant chemotherapy.~     CAO/ARO/AIO: German Rectal Cancer Study Group~   "
53002|NCT02363361|"~     This is a phase II, single center, open-label, non randomized clinical study to assess the~     uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients.~     The aim is to determine if Imatinib reaches sufficient blood levels when given to patients~     with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety~     and tolerability of this drug treatment.~   "
53003|NCT02363348|"~     Randomized double-blind controled clinical trial to assess the efficacy and safety of~     L-arginine to prevent preeclampsia.~      applied to pregnant women with risk factors for preeclampsia. the main result was the~     development of preeclampsia as well as side effects to taking l arginine besides perinatal~     outcomes~   "
53004|NCT02363335|"~     Background:~      The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease~     (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that~     this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is~     a medication presently used to treat diabetes. Researchers think that both of these drugs~     may decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is~     secreted in the small intestines and stomach and is also known as an incretin. Researchers~     want to study how these drugs affect blood sugar, insulin, and other hormones in the blood.~      Objectives:~        -  To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar~          and insulin.~        -  To better understand GLP-1 and other gut hormones. This may lead to new treatments for~          type 2 diabetes.~      Eligibility:~        -  Healthy volunteers age 21 55.~        -  Body Mass Index (BMI) less than 30~      Design:~      -This study will require one screening visit and four study visits, scheduled about 3-weeks~     apart.~      Screening visit requires participants to arrive after fasting for 10 hours and have the~     following:~        -  Medical history, physical exam, height, weight, blood pressure measurements and blood~          and urine tests.~        -  A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored~          drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior~          to drinking the beverage and 2-hours later.~        -  An electrocardiogram (EKG) to measure the electrical activity of the heart.~        -  Questionnaires about risk for depression or suicide.~      Study visits 1to 4:~        -  Participants will arrive the evening prior and blood work will be done to confirm~          eligibility. They will not eat or drink anything except water starting at 8:00 p.m.~        -  About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an~          arm vein and used to take 20 blood samples over a period of about 11 hours.~        -  Participants will receive one of the following study medication/placebo groupings in~          random order:~             1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill~             2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill~             3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill~             4. 2 placebo pills~        -  One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to~          drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10~          hours to measure blood sugar, insulin and other hormones. At the end of the test, they~          will be given a meal.~        -  Participants will answer questions about side effects and symptoms. They will receive a~          follow-up phone call within 10 days.~   "
53005|NCT02363322|"~     Background:~      - Ebola is a viral infection that can spread quickly and causes life-threatening disease.~     Right now there is an Ebola outbreak in many countries in West Africa. There are no approved~     treatments for Ebola. But possible treatments are being developed. Researchers need to study~     these treatments to see if they help people get better.~      Objective:~      - To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental~     drugs to advanced Ebola care can reduce the risk of death.~      Eligibility:~      - People who have recently been diagnosed with Ebola, usually by a test called the~     Polymerase Chain Reaction (PCR), and have been hospitalized in an isolation unit for~     treatment.~      Design:~        -  Participants will be randomly assigned to Group A or B. Both groups will get advanced~          level care. One group will also get an experimental drug.~        -  Participants may have blood tests. They may have another PCR test.~        -  Researchers will try to learn how the participant got Ebola.~        -  Participants put in the experimental drug group may start taking medicine within 24~          hours of enrollment. It may be given by mouth or intravenously. Additional doses may be~          needed.~        -  Participants may have a series of timed blood tests over the first 24 to 48 hours after~          they take the medicine.~        -  Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.)~          may also be collected.~        -  Participants will be followed for up to 60 days. They may be evaluated for any~          long-term effects of the experimental treatment(s). They may be asked to return for 1~          or more outpatient visits.~        -  For consenting participants, follow-up will be extended for up to one full year past~          Day 58 with contact/visits every 1-3 months to assess for a history of signs or~          symptoms potentially consistent with late onset of virologic relapse syndrome.~   "
53006|NCT02363309|"~     Background:~      - Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is~     closely linked to health problems like obesity and diabetes. Researchers want to use a~     breath test to measure the metabolism of fatty acids and learn more about the causes of~     disease. They will compare the results between people who do and do not have NAFLD. They~     will also repeat the test in people with NAFLD after treatment to see improvement.~      Objectives:~      - To measure the metabolism of fatty acids and compare them between people who do and do not~     have NAFLD, and people with NAFLD before and after treatment.~      Eligibility:~        -  People age 21 and older with NAFLD~        -  Healthy volunteers~      Design:~        -  Participants will be screened with medical history, physical exam, and fasting blood~          tests.~        -  Participants will fast overnight.~        -  Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a~          narrow plastic tube will be put under their nostrils. It will be connected to a breath~          test device.~        -  Participants will drink palmitate or acetate in a heated liquid meal (Ensure).~          Palmitate is a fatty acid and acetate is a small molecule that is a building block for~          fatty acids. Both palmitate and acetate are natural compounds that are in our body and~          our food.~        -  Participants will sit for 6 hours. They can read, watch television, work on a computer,~          or other relaxed activity. The air they breathe out from their nose will be collected~          and analyzed. They may take a bathroom break after 3 hours. They may drink water after~          3 hours.~        -  Participants will get a meal after the test.~        -  Participants will have another visit at least 1 week later. They will repeat the test~          with the other compound (acetate of palmitate).~        -  Participants may be asked to repeat a test to study the result of a change like weight~          loss or medicine. Thus, participation can last from 1 week to several years.~   "
53048|NCT02362763|"~     Randomized controlled trial designed to determine whether acupuncture is an effective~     treatment for vestibulitis.~   "
53095|NCT02362139|"~     In the investigators institution, there is a wide use of Papaverine in delivery room, but~     this use is optional, and is left to the discretion of the physician.~      The aim of the investigators study is to prospectively evaluate the influence of Papaverine~     administration in the latent phase of labor, on the duration of labor.~   "
53007|NCT02363296|"~     Background:~      - Brain activity changes with changes in body temperature. Brain activity can be studied~     with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool~     the brain through the scalp using a cooling cap. They want to see if cooling changes the~     brain and body s response to TMS.~      Objectives:~      - To look at the effects of cooling on the brain.~      Eligibility:~      - Right-handed adults age 18 50 who can abstain from caffeine and tobacco.~      Design:~        -  Participants will be screened with medical history and physical exam. They will be~          asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test.~          They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI,~          participants lie on a table that slides in and out of a metal tube that takes pictures.~        -  Participants will have 3 outpatient visits. The following procedures will occur at each~          visit.~        -  Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through~          the cap. It will feel like an ice pack in a towel. Their core temperature will be~          monitored. Their temperature will also be measured under their tongue and on scalp,~          stomach, forearm, and calf.~        -  Participants will have TMS before and after wearing the cap. A brief electrical current~          will pass through a wire coil held on their scalp. Electrodes that detect muscle~          movement will be placed on their hand. They will also have repetitive TMS, which uses~          repeated magnetic pulses. Their wrist will also receive a shock.~   "
53008|NCT02363283|"~     This phase II trial studies how well glembatumumab vedotin works in treating patients with~     middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the~     body (metastatic) or has returned at or near the same place after a period of time during~     which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink~     the tumor by binding to tumor cells and delivering tumor-killing substances to them.~   "
53009|NCT02363270|"~     Our recent research comparing the efficacy of intravenous ketamine to morphine has shown~     ketamine to provide equivalent relief of moderate to severe acute pain in emergency medicine~     patients. Secondary analysis of the research has also revealed ketamine to have~     statistically more side effects. The investigators believe that increasing the time of~     administration of the ketamine, from a push injection to a drip infusion, will minimize the~     side effects experienced by recipients of ketamine.~      During our Ketamorph trial the investigators saw that 70% of patients receiving ketamine~     experienced a known side effect of the medication, compared to 51% of the morphine group.~     The most common side effect was dizziness (22 of 45 pts), Feeling of Unreality (12 of 45),~     Mood Changes (6 of 45). During this trial there we NO adverse effects that we beyond the~     expected side effects profile of either medication and none of the participants required~     intervention as a result of the study medication.~   "
53010|NCT02363257|"~     Three years since the Smoke Free Mumbai campaign and six years since the ban on smoking in~     public places was implemented. It is necessary to review the situation at this point in time~     so that corrective actions if necessary can be taken. Hence, this study is planned to~     understand the perceptions and attitudes of commuters and bus employees (drivers, conductors~     and ticket checkers) regarding the law, its implementation, reactions from the commuters,~     violations observed, violations reported.~      This study will help evaluate the implementation of provision of prohibiting smoking in~     public places and help understand how to increase the compliance. The results will inform~     enforcement and public health agencies about where to target enforcement and public~     education resources.~   "
53011|NCT02363244|"~     This is a pilot study to assess the cell adequacy and quality of Pap smears and adequacy of~     samples for HPV DNA virus test done after application of 5%acetic acid in a VIA~     test.Normally a Pap test and HPV DNA test is performed before application of acetic acid. It~     is assumed that application of acetic acid may alter the cell adequacy of Pap test and HPV~     DNA test, if any of the above tests is done immediately after VIA test.The present study~     aims to see the effect of 4-5% acetic acid [vinegar] on the cell adequacy and quality of Pap~     smear and sample adequacy for HPV DNA test.~   "
53012|NCT02363231|"~     The process of weaning from mechanical ventilation was decided after clinical judgment and~     weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal~     Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of~     respiratory muscles in critically ill patients has not been established. The objective of~     this study was to assess the relationship on MIP at extubation on one-year mortality in~     critically ill patients.~   "
53013|NCT02363218|"~     Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall~     survival for HCC patients treated with CyberKnife SBRT at 2 years.~      Secondary Objective(s): 1) To determine overall survival for HCC patients treated with~     CyberKnife SBRT at 1 year 2) To determine local control using RECIST and EASL criteria at 1~     and 2 years 3) To assess progression-free survival at 1 and 2 years 4) To assess acute and~     late toxicities following CyberKnife SBRT.~      Hypothesis: Overall survival rate of HCC patients at one year after SBRT treatment is not~     less than 65%.~      Study Design: Single arm study. Patients will undergo a CT scan with and without contrast~     and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered~     on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be~     tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3~     fractions within a 7 day window at the discretion of the investigator.~      Sample size: The sample size required is 93 with a power of 90%, p=0.05, 50% response rate~     is considered not effective (p0) and 65% overall survival rate at 1 year (p1) is considered~     effectiveness of the treatment. The estimated drop-out rate is 20%, so the total sample size~     would be 117.~      Statistical Considerations: The set of Intention-To-Treat (ITT) will be analyzed. All~     patients will be censored at their last visit, including the patients lost to follow-up. All~     patients will be followed and counted in the therapy to which they were assigned, even if~     they decline that therapy. Only those patients who refuse (in writing) to have their~     outcomes count in the study's conclusions will not be included in the analyses from that~     time forward; however, the follow-up data for such patients will be included up until the~     time they withdraw consent. Such patients will be replaced.~      Baseline characteristics of patients will be presented with summary statistics.~     Time-to-event survival rates for OS and DFS will be estimated using the Kaplan-Meier method~     and presented at one and/or two years. The incidence of acute and late toxicities will be~     presented in tabular form on both a per-patient and per-event basis.~   "
53014|NCT02363205|"~     The purpose of this study is to determine whether tailored internet-administrated cognitive~     behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and~     comorbid anxiety symptoms.~   "
53065|NCT02362529|"~     The purpose of this study is to determine if translocator protein total distribution volume~     (TSPO VT) is elevated in major depressive disorder that is not responding to medication and~     if adding minocycline can affect TSPO VT. Many remain treatment resistant with common~     antidepressant treatments and the investigators think it may be due to poor targeting of~     brain pathologies.~   "
53066|NCT02362516|"~     To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as~     safety and tolerability, and to evaluate the effect of different doses of BI 425809 on~     biomarkers levels in cerebrospinal fluid.~   "
53015|NCT02363192|"~     Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe~     asthma that needs the maximum available treatments advised in national asthma guidelines~     (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network~     British Guideline on the Management of Asthma'). Despite this, asthma is still inadequately~     controlled in about half of these patients and they are classed as having 'difficult~     asthma'. There maybe potential for improvement of the care and health of these patients~     through better use of medicines and greater input from pharmacists, but more research is~     needed.~      The aim of the study is to measure the effects over six months of coordinated information~     and advice about medicines from hospital and community pharmacists on asthma control in~     patients with difficult asthma. The patients in the study (52 in total) will be recruited~     from adult patients attending a specialist difficult asthma clinic in a hospital.~      Patients will be randomly chosen to have either an appointment with the specialist~     pharmacist (intervention group), or usual medical care (control group). Usual care will~     involve seeing the Consultant or Specialist Registrar (doctor) in the clinic. Patients in~     the intervention group will receive i) assessment and education on asthma, and review of~     their inhaler technique, from a hospital Advanced Clinical Pharmacist and ii) will also be~     referred for a medicines use review from their usual community pharmacist (chemist), to take~     place 1-2 months after their hospital clinic appointment. The Advanced Clinical Pharmacist~     will be working closely with the Consultant.~      Results will be measured using methods that have been developed by experts in asthma and~     tested in previous research. Asthma control will be measured using Juniper's Asthma Control~     Questionnaire. Other measurements will cover quality of life, use of medication, use of~     healthcare resources, and inhaler technique.~   "
53016|NCT02363179|"~     The investigators will conduct a prospective quasi-experimental design study of patients in~     the University of Florida Health Emergency Department. Live preferential music will be~     performed for patients in the emergency department on alternating days over 20 weeks, and~     subjects exposed to the music intervention will be matched to a cohort that present to the~     emergency department on days with no music to assess impact on patient and healthcare~     provider satisfaction, pain medication utilization, length of stay, and cost of care.~   "
53017|NCT02363166|"~     Given that the Emergency Department (ED) has become the entry way for large populations of~     patients into the health care system, a strategy of sampling MRSA isolates in ED populations~     and merging this information with patient-level data may present a window to hypothesize and~     investigate CA-MRSA transmission within the community and its impact on hospital-acquired~     infections.~   "
53018|NCT02363153|"~     This study examines the effects of individualized diet and exercise plans on muscle~     strength, quality of life and respiratory function in Pompe disease. Subjects will be given~     a diet and exercise plan based on their individual needs, which will be followed for 16~     weeks. Participants will also be provided with an activity tracker, such as a FitBit or~     Apple Watch, in order to track their diet and exercise activities, and will also come to the~     University of Florida for exercise tests, respiratory tests and questionnaires.~   "
53019|NCT02363140|"~     The menisci in the knee joint are important for normal functioning of the knee. Meniscus~     tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the~     meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood~     supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the~     treatment option ie repair versus partial meniscectomy.~      This study aims to identify any changes that occur in the meniscus blood supply. The~     following are the main aims of the 'MOVE'study-~        1. Use of non-invasive methods ie MRImaging to assess meniscus vascularity to~          preoperatively plan treatment and advice patient on recovery.~        2. The study would assess changes in meniscus blood supply depending on age of the~          patient.~        3. The study aims to assess the alteration in meniscus blood supply following an~          arthroscopic(key hole) meniscal repair operation.~   "
53020|NCT02363127|"~     Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the~     impact on the ongoing pregnancy rate with the use of two progesterones with different~     administration routes, in recipients of fresh embryos from donor oocytes, undergoing~     endometrial preparation for fresh embryo transfer.~   "
53021|NCT02363114|"~     The primary objective of this study is to determine whether baseline DOC screening can add~     to clinical and demographic data to predict the occurrence of a composite negative outcome~     (any of: recurrent stroke, myocardial infarction, death, or admission to a long-term care~     (LTC) / complex continuing care (CCC) facility) within one year of screening, in stroke~     prevention clinic patients.~   "
53022|NCT02363101|"~     The purpose of this study is to evaluate the costs, health-related quality of life and~     preference values from lung cancer patients assisted in a Brazilian public health care unit.~   "
53023|NCT02363088|"~     Cervical cancer is the most common cancer in women under 35 years and is a major public~     health concern. Fortunately, the natural history of this malignancy can be beneficially~     improved through cytological screening. However, the success of screening programmes depends~     on their ability to attract the at risk population, as well as the analytical sensitivity~     and specificity of the screening test. In the UK, screening consistently falls short of the~     80% national target and recent evidence shows uptake is decreasing, in part due to the~     introduction of HPV vaccination programmes. In the under 30s London population, average~     coverage only reached 50% in 2013. Given this information, the cervical screening programme~     is under increasing pressure to improve uptake, and need an evidence based intervention.~      We aim to improve the uptake of cervical screening using SMS messaging through a randomised~     controlled trial. The trail will evaluate both the prevalent and incident rounds of~     screening and within the intervention group, analyse how the content of text reminders~     influences their effectiveness. Specifically we will evaluate a) neutral b) messenger c)~     social norms d) framed gain/loss reminders. Unlike our previous trial, this SMS reminder~     will encourage the booking of an appointment which has never been tested, rather than simply~     reminding women to attend. All women being invited for cervical screening, registered at~     participating GPs within Hillingdon will be eligible to participate. Women will also be~     provided with a 2 week window during which they can opt out of the research. Given the~     sample sizes we predict the trial will take 9 months.~   "
53024|NCT02363075|"~     The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine~     sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.~   "
53025|NCT02363062|"~     The major objective of the project is to map/identify new loci/genes, by a combination of~     whole exome sequencing and genome-wide linkage in autosomal dominant FTLD families excluded~     for known mutations.~      Several secondary goals will be attained in the course of during the project:~      For each novel gene identified in this project, we will determine the spectrum of mutations,~     evaluate their frequency and characterize the associated phenotypes. This will allow us to~     establish genotype-phenotype correlations in a large number of families, which will improve~     the nosology of these disorders and the diagnostic procedures;~   "
53032|NCT02362971|"~     The aim of this study is to evaluate the external validity of a randomized controlled trial~     comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced~     femoral neck fracture.~      The hypotheses are that patient reported hip function, quality of life are better and~     healthier in those included in the randomized controlled trial than those excluded. The~     external validity of the randomized controlled trial is acceptable.~      A prospective randomized controlled trial is planned and patients with a displaced femoral~     neck fracture will be included and randomized between either a hemiarthroplasty or total hip~     arthroplasty. All patients screened will be included in a prospective cohort study for~     evaluation of the external validity of the randomized controlled trial. The prospective~     cohort study will consist of 3 different groups.~      Patients included in the randomized controlled trial will form group 1. Patients eligible~     for the randomized controlled trial but did not give their informed consent and therefore~     excluded, form group 2.~      Patients with a femoral neck fracture which by any reason were excluded form group 3.~      Primary endpoint is patient-reported hip function (Harris hip score) and pain on the~     operated extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality~     of life evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of~     the complications, periprosthetic fracture, dislocation, revision surgery due to wound~     infection (deep and superficial) and loosening of the components. Baseline data, age, sex,~     comorbidity, cognitive status, weight, height, motor function, complications and~     reoperations. Follow up is performed 1-2 years after surgery.~      Group 1 is followed up in the ongoing randomized controlled trial by visits to the~     orthopedic department at Danderyd Hospital. Group 2 and 3 are followed up by telephone~     interview 1-2 year after surgery.~   "
53033|NCT02362958|"~     Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With~     Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.~   "
53034|NCT02362945|"~     Post-Partum Hemorrhage (PPH) is a common obstetrical complication. It may occur after both~     vaginal and cesarean delivery with a reported prevalence of 4-6% of deliveries [1].~     Prophylactic treatment with oxytocin after fetus extraction is a common practice.~     [1,2]Transexamic acid - Hexakapron is a potent antifibrinolytic, it prevents lysine adhesion~     to plasminogen molecules by blocking its binding site. It can lower fibrinolysis rate and by~     that reduce bleeding [9]. Systematic treatment of anti-fibrinolytic drugs is in surgical~     practice after procedures such as coronary artery bypass graft, orthopedic surgeries and~     liver transplantation [10-13]. Hexakapron is an FDA approved drug, it is defined as a class~     B drug for pregnancy and lactation [12], it is already being used in a non-routine fashion~     in the delivery room during PPH.In obstetrics Hexakapron given before vaginal or cesarean~     delivery has been presumed to decrease blood loss and PPH. 2 studies that included 453 woman~     reported decrease in PPH (RR 0.51, 95% CI 0.36 to 0.72) [13-15]. However specific protocols~     for prophylactic treatment with Hexakapron as available with oxytocin are lacking, and~     further research is necessary to determine such guidelines [16].~   "
53035|NCT02362932|"~     The purpose of this study is to determine the health impact of a basic sanitation~     intervention in Maputo, Mozambique.~   "
53036|NCT02362919|"~     The aims of the study are to a) identify individuals with a poor response to influenza~     vaccination and b) identify factors associated with a poor response to influenza~     vaccination.~   "
53037|NCT02362906|"~     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine~     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.~   "
53038|NCT02362893|"~     The purpose of the study is to access the change in mean daytime systolic blood pressure in~     participants with essential hypertension not adequately controlled (defined as mean systolic~     daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an~     intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by~     ABPM or a control group with standard ABPM.~   "
53039|NCT02362880|"~     The main purpose of the study is to assess safety of a single dose of FBB followed by PET~     scan in individuals at risk of genetic Alzheimer's disease.~   "
53040|NCT02362867|"~     The protocol will define the clinical study for Ortho Development's Balanced Knee® System~     (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This~     clinical study will compare the clinical outcomes of BKS to currently marketed devices.~   "
53041|NCT02362854|"~     The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to~     conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective~     clinical, radiographic and microbiologic split-mouth study was conducted to test the~     following null hypothesis; adjunct application of a diode laser, in the conventional~     treatment of peri-implantitis, are not associated with a statistically significant~     difference regarding the microbial counts, marginal bone loss and peri-implant parameters.~   "
53042|NCT02362841|"~     There are no available criteria for determining the optimal flow rate and mean arterial~     pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide~     tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for~     guiding hemodynamic optimization under CPB. The goal of this exploratory study was to~     determine the factors that influence PtCO2 variations during CPB.~      DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every~     10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital~     PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively~     included.~   "
53043|NCT02362828|"~     The aims of EPiMAP Obstetrics are:~        -  to identify risk factors for failure of epidural blood patch in the obstetric~          population for management of post dural puncture headache.~        -  to describe European practices in the management of accidental dural puncture in the~          Obstetric population.~   "
53044|NCT02362815|"~     We designed a two arms prospective, randomised, simple blinded trial to compare the impact~     of clear liquid intake on gastric content before delivery. We hypothesize that there will be~     no difference between the two groups, leading to safety of clear liquid intake during~     labour.~   "
53045|NCT02362802|"~     This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial~     tissue with respect to its potential micro damage measured by several myocardial markers,~     especially by high-sensitive TroponinT.~   "
53046|NCT02362789|"~     The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and~     lesional biomarkers during 16 weeks of treatment with 300 mg secukinumab in patients with~     moderate to severe psoriasis and a high pruritus involvement at baseline. For patients who~     achieve extensive remission defined as a PASI response of 98-100%, the kinetics of psoriasis~     and pruritus symptoms will be further explored during a randomized withdrawal phase of 16~     weeks. Biopsies will be taken to investigate lesional biomarkers related to the pathogenesis~     of pruritus in psoriasis patients.~   "
53047|NCT02362776|"~     This study aims to determine whether metabolic changes occur in blood plasma of cancer~     patients, and whether these changes can be used as a biomarker to detect cancer. These~     analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.~   "
53049|NCT02362750|"~     The Evaluating Cancer Survivorship Care Models project is an innovative 3-year study that is~     collecting data to help understand how to best deliver follow-up care to cancer survivors.~     Cancer is a complex disease requiring complex treatments that can cause lasting impacts~     after treatment ends. Some patients face physical, psychosocial, spiritual and/or practical~     challenges as they adjust to life after cancer. Fortunately, health care providers have~     begun to focus on the consequences of cancer and its treatment and are more actively working~     with cancer survivors to manage post-treatment needs and care.~      Led by the George Washington University and funded by the Patient-Centered Outcomes Research~     Institute, this project brings together representatives from the Commission on Cancer, the~     Cancer Support Community, LIVESTRONG and the American Cancer Society as well as cancer~     survivors and healthcare professionals to better understand how different strategies or~     models of care impact outcomes that are most important to cancer survivors. The project will~     focus on survivors of breast, prostate and colorectal cancers and will be relevant for~     understanding the needs and preferences of survivors of other cancers as well. The emphasis~     is on patient-centered outcomes, which are outcomes that are most significant to patients,~     such as patient satisfaction and quality of life.~   "
53050|NCT02362737|"~     This study will test ways to improve health behaviors using an intervention that has been~     specially designed for African-American men. The program, called Active & Healthy~     Brotherhood (AHB), will provide information on basic health, and healthy eating, physical~     activity, stress management, and how to get medical care when needed.The AHB intervention~     will be compared to a control group that will receive basic health information in videos and~     brochures.~   "
53051|NCT02362711|"~     The purpose of this long-term study is to determine whether NPC-16 is effective in the~     treatment of dysmenorrhea.~   "
53052|NCT02362698|"~     this research adopted multicentered, randomly and parallel control methods to observe the~     clinical effects of electro-acupuncture combined psychological intervention on internet~     addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.~   "
53053|NCT02362685|"~     Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of~     using functional tests when this diagnosis is suspected. Exercise increases the~     concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and~     ammonia) especially during recovery. The purpose of this study is to compare the results of~     exercise testing with to the data from muscle biopsy or genetic analysis.~   "
53054|NCT02362672|"~     The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is~     effective for the relief of moderate to severe chronic low back pain as compared to a~     placebo.~   "
53055|NCT02362659|"~     The purpose of this observational registry is to compare the safety and efficacy of an~     antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic~     versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This~     registry will assess whether the antithrombotic therapy intensity will vary positively with~     physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI),~     and whether an inverse association will be observed with perceived bleeding risk.~      This study will also evaluate the physician use of objective benefit-risk assessment scores~     and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF)~     patients undergoing PCI. Additionally the study will investigate whether patient perceived~     relevance and accessibility of anti-platelet and anticoagulant treatment regiments will~     predict treatment adherence and whether non-adherence will independently influence outcome.~      Approximately 2500 subjects with non-valvular AF undergoing all-comer PCI with stenting will~     be enrolled in North America and Europe, sites to be determined. Follow-up will be done via~     telephone by trained research coordinators at each participating site at 30 days, 6 months~     and 12 months.~   "
53056|NCT02362646|"~     The main purpose of this research is to determine whether injecting mesenchymal precursor~     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)~     is safe. MPCs are normally present in human bone marrow and have been shown to increase the~     development of blood vessels and new heart muscle cells in the heart. In addition, this~     research is being done to test whether injecting the MPCs into the heart is effective in~     improving heart function.~   "
53057|NCT02362633|"~     The purpose of this study is to investigate the long-term effect of Transcranial Direct~     Current Stimulation (tDCS) on appetite control related brain regions.~   "
53058|NCT02362620|"~     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer~     Treated With doceTaxel and Cabazitaxel (PROSTAC).~   "
53059|NCT02362607|"~     The investigators aim to assess whether using integrated diabetes management protocol using~     smartphone would increase glucose control among diabetes patients.~   "
53060|NCT02362594|"~     This study will assess whether post-resection adjuvant therapy with pembrolizumab improves~     recurrence-free survival (RFS) as compared to placebo for high-risk participants with~     melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether~     pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed~     cell death ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for~     stage of disease and region and then will be randomly assigned to receive either~     pembrolizumab or placebo.~   "
53061|NCT02362581|"~     Comparison of prophylaxis and on-demand treatment in children with moderate to severe~     hemophilia A.~      This study determines to compare the efficacy of prophylaxis and on-demand treatment in~     moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok,~     Thailand~   "
53062|NCT02362568|"~     The purpose of this study is to determine if cervical ultrasound exploration can predict~     difficult intubation better than main validated clinical criteria.~   "
53063|NCT02362555|"~     Ossification of nuchal ligament often observed in patient with chronic neck pain, previous~     study showed ossification of nuchal ligament was associated with cervical spondylosis and~     radiculopathy. Patient with chronic neck pain was divided into two groups according to the~     presence of ossification of nuchal ligament on cervical radiographic images.~      This study is to evaluate and compare the neck function including range of motion, neck~     strength and pressure pain threshold, radiography characteristics and functional disability~     between two groups.~   "
53064|NCT02362542|"~     The purpose of this study is to investigate the effect of Transcranial Direct Current~     Stimulation (tDCS) on appetite control related brain regions.~   "
53068|NCT02362490|"~     Antiviral therapy is the most important method to slow and stop the progress of the disease~     in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively~     suppress HBV replication, but it should be continue used and relapse would happen in most~     patients after withdrawal of therapy. However, long-term use of NA could induce viral~     resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and~     non-specific immune function in chronic hepatitis B patients, make patients get immune~     control to HBV infection and obtain sustained response after treatment. Thus the CHB~     patients on the treatment of NA should be stop NA treatment after interferon treatment. In~     this study, the effects of interferon treatment in CHB patients who were on the NA treatment~     and obtained HBsAg level≤250 IU/ml.~   "
53069|NCT02362477|"~     The immediate objective of this project is to evaluate the clinical effectiveness of a~     telemental health modality (video-teleconferencing) for providing an evidence-based group~     intervention to female rural veterans, Reservists, National Guardsmen, and civilians~     suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to~     an already CDMRP-funded study that completed in July 2014 treating male combat veterans with~     military-related PTSD. The long-term objective of this project is to disseminate an~     empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that~     will extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be~     as effective as the in-person mode of service delivery for providing CPT.~   "
53070|NCT02362464|"~     Background:~      - Few studies or literature are available about the long-term safety of repeated peptide~     vaccinations in people over a period of time. Long-term vaccination may be needed to control~     tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now~     they want to give those same men the new version of the vaccine. They want to see if it~     produces different types of immune responses and also ensure that repeated vaccinations are~     safe.~      <TAB>~      Objectives:~      - To find out the long-term safety of repeated TARP peptide vaccinations.~      Eligibility:~      - Men who took part in NCI protocol 09-C-0139.~      Design:~        -  Participants will be screened with blood tests, scans, physical exam, medical history,~          and an evaluation of how well they perform everyday activities.~        -  Participants will have apheresis. Blood will be removed with a needle from one arm. A~          machine will separate the white blood cells. The blood, minus the white cells, will be~          returned through a needle in the other arm.~        -  Participants will have 14 visits. At each visit, they will have a physical exam and~          blood tests. They will discuss any side effects.~        -  Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine~          will be made from the participants own cells.~        -  Participants will get a Vaccine Report Card to complete after receiving vaccine.~        -  The study lasts 96 weeks.~   "
53071|NCT02362451|"~     Background:~      - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after~     their primary prostate cancer treatment are at increased risk for their cancer to progress.~     The time it takes to progress is highly variable. One way to predict this progression is~     based on the change in PSA levels over time. This is called the PSA doubling time (PSADT).~     Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the~     PSA has become detectable again or has started to rise after primary treatment, but has not~     spread to other organs.~      Objectives:~      - To test a vaccine s effectiveness on the rate of PSA increase using PSADT and tumor growth~     rates.~      Eligibility:~      - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.~      Design:~        -  Participants will be screened with blood tests, scans, physical exam, and medical~          history. Their prostate cancer will be confirmed.~        -  Participants will undergo apheresis. Blood will be removed with a needle from one arm.~          A machine will separate the white blood cells. The blood, minus the white cells, will~          be returned through a needle in the other arm.~        -  Participants will have 14 visits. At each visit, they will have a physical exam and~          blood tests. They will discuss any side effects.~        -  Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12,~          15, and 24. Both will be made from the participants own cells.~        -  Participants will be selected randomly to receive either active vaccine or placebo. For~          every two participants assigned to active vaccine, one participant will be assigned to~          placebo vaccine.~        -  Participants will get a Vaccine Report Card to to complete after receiving vaccine.~        -  The study lasts 96 weeks.~   "
53072|NCT02362438|"~     Background:~      - The Gigaxonin gene lets the body make a protein chemical called Gigaxonin. Nerves need~     Gigaxonin to work properly. Giant Axonal Neuropathy (GAN) causes a shortage of functional~     Gigaxonin. Nerves stop working normally in people with GAN. This causes problems with~     walking and sometimes with eating, breathing, and many other activities. GAN has no cure.~     Over time, GAN can shorten a person s life. Researchers want to see if a gene transfer~     treatment may help people with GAN.~      Objectives:~      - To see if a gene transfer is safe and shows potential to help people with GAN.~      Eligibility:~      - People age 5 and older with GAN.~      Design:~        -  For 2 months participants must live full-time within 100 miles of the NIH.~        -  Participants will be screened by phone and in person. They will take many tests. Some~          are listed below. Their medical records will be reviewed. Their caregivers may be~          contacted.~        -  Participants will have a total of about 30 visits, weekly, monthly, and then yearly~          over 15 years. They will include many of the tests below.~        -  Physical and nervous system exams.~        -  Blood, urine, and stool samples.~        -  Nerve, lung, heart, and eye tests.~        -  Questionnaires.~        -  MRI scans, nerve biopsies, and spinal taps. Participants will be sedated for some~          tests.~        -  Speech, memory, muscle, and mobility tests.~        -  Skin biopsy (small sample removed).~        -  Participants will take many medicines. Some require intravenous lines.~        -  Participants will get the gene transfer through an injection by spinal tap into their~          cerebrospinal fluid, which flows around the brain and spinal cord. The genes are packed~          in a modified virus that carries the genes to cells in their body. Participants safety~          is not guaranteed.~   "
53096|NCT02362126|"~     Observational prospective multicenter study to investigate efficacy and safety of endoscopic~     full thickness resection in the lower GI tract using a novel over-the-scope full thickness~     resection device.~   "
54403|NCT02345018|"~     The goal of this registry study is to provide insight in the safety and efficacy of~     treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm,~     insufficient antero-lateral branches and insufficiency of the GSV below the knee.~   "
53073|NCT02362425|"~     Background:~      - Ryanodine receptor type 1-related myopathies (RYR1-RM) are the most common muscle diseases~     that people are born with in the U.S. They affect development, muscles, and walking.~     Researchers want to test a new drug to help people with these diseases.~      Objectives:~      - To see if the drug N-acetylcysteine decreases muscle damage in people with RYR1-RM. To see~     if it improves their exercise tolerance.~      Eligibility:~      - People age 7 and older with a confirmed genetic diagnosis of RYR1 or a clinical diagnosis~     of RYR1 and a family member with a confirmed genetic diagnosis.~      Design:~        -  Participants will be screened with a checklist of criteria. They will have a muscle~          biopsy. A needle will remove a tiny piece of muscle in the lower leg.~        -  Study visits will take several days.~        -  Visit 1:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and saliva tests~        -  Questions about symptoms and quality of life~        -  Heart, lung, and walking tests~        -  Muscle Oxygenation Capacity Test. A blood pressure cuff around the thigh will be~          tightened for up to 10 minutes.~        -  Biodex testing, stretching the leg against resistance~        -  Muscle ultrasounds. A probe will be moved over the skin.~        -  Participants may be photographed or videotaped during procedures.~        -  They may have a muscle biopsy.~        -  Six months later, visit 2 will repeat visit 1. Participants will start taking the study~          drug dissolved in water or placebo three times a day for 6 months.~        -  Participants will stay at NIH for 2 days after starting the study drug.~        -  Participants will keep an online pill diary daily and be contacted by phone during the~          study.~        -  Six months after starting the study drug, study visit 3 will repeat some or all of~          visit 1.~   "
53074|NCT02362412|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of~     switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet~     at the equivalent total daily dose in bipolar disorder patients with major depressive~     episodes.~   "
53075|NCT02362399|"~     To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from~     growth restriction to support its use later as prolonged therapy in those pregnancies at~     higher risk for such complication.~   "
53076|NCT02362386|"~     The objective of the study is to assess the logistical and biological feasibility of~     preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision~     using the Celution® System for autologous, same-day application to the burn wound.~   "
53077|NCT02362373|"~     The investigators will conduct a prospective, seven-month pilot study to explore~     pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the~     levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will~     enroll twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs~     (AED) therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and~     seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence~     of ovulation three weeks after insertion (serum progesterone >3ng/ml), bleeding and~     spotting, endometrial thickness, continuation, satisfaction and adverse events (removals,~     expulsions, side effects). The investigators will conduct a baseline month assessment,~     insertion visit, and follow-up visits at 21 days, three months and six months.~   "
53078|NCT02362360|"~     The purpose of this study is to investigate the influence of a new ostomy product on the~     peristomal fit for people with an ileo- or colostomy.~   "
53079|NCT02362347|"~     The purpose of this investigation is to determine the effect of a weighted compression vest~     in addition to usual medical care and exercise rehabilitation on cardiovascular,~     neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and~     being treated for, a mild traumatic brain injury.~   "
53080|NCT02362334|"~     This study evaluates the various ocular parameters which are necessary for ocular biometry~     and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence~     refelctometry.~   "
53081|NCT02362321|"~     Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas~     are mostly based on observational studies. Here we present data from a prospective~     randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with~     dexamethasone or placebo for 30 days.~      Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed~     CSDH were recruited from a single center and randomized in order to receive dexamethasone or~     placebo as a conservative treatment. Patients affected to the treatment group received oral~     dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed~     for 6 months and the rate of success of conservative treatment versus placebo was measured.~     Parameters such as hematoma thickness and global impression of change were also compared~     before and after treatment with chi-square tests. Adverse events and complications were~     documented.~   "
53082|NCT02362308|"~     The investigators will test the hypothesis that endogenous aldosterone impairs insulin~     secretion and insulin sensitivity in subjects with primary aldosteronism.~   "
53083|NCT02362295|"~     PARME study had 3 objectives:~        -  To identify the specific number of incarcerated individuals with terminal illness in~          need of palliative care.~        -  To describe the health and penal situation of these prisoners.~        -  To analyse the situation of these ill prisoners especially in the context of suspended~          sentence for medical ground~      In order to answer these questions, the investigators used a mixed method research.~   "
53084|NCT02362282|"~     Recent research in gait training for stroke survivors showed that coordinated gait~     components can be best restored using the following interventions together: coordination~     exercises, over ground gait training, and body weight supported treadmill training (BWSTT).~     These results are important because, to the investigators' knowledge, there have been no~     other reports of the restoration of coordinated gait components for those with persistent~     gait deficits (> 6 months after stroke). However, a remaining problem was that the restored~     coordinated gait movements measured in the laboratory did not generalize for many subjects~     to the everyday environment. The confluence of several factors can cause lack of~     generalization. First, dual task performance (gait and cognitive attention task) can degrade~     both gait and attention ability, even in healthy adults. Second, stroke can impair~     attention. Third, during walking in the everyday environment, attention is required in order~     to safely process normally occurring stimuli. Therefore, given the success of the new gait~     training protocol in the lab setting, it is important to address the problems remaining for~     generalization of the recovered coordinated gait pattern to the everyday environment. The~     primary hypothesis of this study is that greater gains in gait speed will be produced by~     combined motor and cognitive training versus motor training alone.~   "
53097|NCT02362113|"~     A total of 300 adults would be included in the present cross-sectional study. glycemic index~     (GI) and glycemic load (GL) would be assessed by using a validated self-administered~     dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of~     Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to~     assess anxiety, depression and psychological distress.~   "
53085|NCT02362269|"~     The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of~     six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334~     community-dwelling post-menopausal women of European and African descent (~167 from each~     ancestry) in a 1:1 ratio between the control arm and the dosing algorithm arm using~     stratified block randomization with a block size of six and stratification by site~     (ancestry). The sample size of 334 includes 10% over-recruitment to allow for loss to~     follow-up. The European ancestry women will be seen in the Madison clinic and the African~     ancestry women will be seen in the Milwaukee clinic. The proposed study will focus on~     post-menopausal women because this is the subset of the population that both Dr. Engelman's~     and Dr. Binkley's preliminary data are drawn from. Moreover, 25(OH)D concentrations are~     typically lower in women and in older individuals, since production of vitamin D in the skin~     following sun exposure decreases with age. Therefore, this group of individuals is likely to~     benefit the most from vitamin D supplementation, especially when personalized based on~     biology using the proposed dosing algorithm.~   "
53086|NCT02362256|"~     The aim of this study is to investigate which method of naltrexone induction during rapid~     opioid detoxification causes stronger stress response and has a higher influence on opioid~     abstinence caused by opioid induction.~   "
53087|NCT02362243|"~     Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back~     and core exercise interventions for low back injury prevention in firefighters. Aim 1.~     Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based)~     relative to control to reduce lost work days related to low back injury and illness in~     firefighters.~      Relevance: Low back injury is one of the most common and disabling disorders in~     firefighters. Thus, novel interventions are needed to counteract the adverse consequences of~     this disorder and its impact on firefighter safety.~      Methods: A cluster randomized controlled trial will be conducted in career, full active duty~     firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3~     intervention groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or~     3) control (n = 115). Participants in the supervised and web-based exercise groups will~     perform back and core exercises previously tested in our recent FEMA-funded grant~     (EMW-2009-FP-00418), twice per week for 12 months while on duty, in addition to their usual~     physical fitness routine - The supervised group will perform exercise under direct~     supervision of certified exercise specialists, and the web-based group will utilize a~     web-based exercise system. The control group will not perform back and core exercises, but~     will continue their usual physical fitness routine and receive brief education on general~     exercise and physical activity principles. Outcome measures include low back injury and~     illness data obtained and cross-checked from various sources, other standard clinical~     outcome measures for low back pain and disability, and validated physical fitness tests.~      Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will~     reduce lost work days related to low back injury and illness by 40% compared with control.~     Assuming positive results, this study will deliver an evidence-based exercise intervention~     for low back injury prevention specifically designed for firefighters and assessed in a~     full-scale randomized controlled trial.~   "
53088|NCT02362230|"~     Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in~     patients with metastatic triple-negative breast cancer that have received at least two prior~     treatments.~   "
53089|NCT02362217|"~     This study is aimed at assessing the safety of candidate Hepatitis C vaccines~     AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered~     separately or in combination to healthy volunteers. The study also aims to assess the~     cellular immune response generated by these vaccines when administered as mentioned above.~   "
53090|NCT02362204|"~     Lung cancer patients experience significant physical symptoms, psychological distress and~     have many supportive care needs that impact on quality of life. Implementing the role of a~     Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers.~      Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect~     longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the~     University Hospital of Lausanne.~      Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and~     unmet supportive care needs across three time points during the first line therapy and ii)~     to explore professional acceptability of the new LCN model evaluating the perceptions of~     barriers and facilitators of the model by the LCN and the other multidisciplinary members of~     the comprehensive lung cancer care team.~      An exact single-stage (no interim analysis) design will be applied to determine feasibility~     for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at~     each data collection (Baseline, Time1, Time2) time point and professional acceptability will~     be explored by focus groups with selected members of the interdisciplinary team.~   "
53091|NCT02362191|"~     Purpose: Using transcranial alternating current stimulation (tACS), the investigators will~     study and attempt to treat mood dysregulation in women with premenstrual dysphoric disorder~     (PMDD).~      Participants: Women between ages 18-45 with a diagnosis of PMDD confirmed by participation~     in a PMDD diagnostic study (IRB# 05-3000).~      Procedures (methods): After a re-screening and consent appointment, eligible participants~     will begin daily ratings and have baseline EEG performed during the follicular and luteal~     phases. Following the luteal phase EEG, the patient will receive, in a double blind~     cross-over fashion, 5 days of tACS, 40 minutes/session, performed in two successive months.~     On the first and fifth days of each treatment, EEG will be performed. Patients' symptoms~     will be assessed at the end of each session and with the daily mood ratings.~   "
53092|NCT02362178|"~     Blood products are commonly used before invasive procedures in patients with end-stage liver~     diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests~     (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before~     invasive procedures and in representing the real coagulation status of cirrhotic patients.~     Notwithstanding they are still used to guide blood products administration before invasive~     procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of~     hypo-hypercoagulability possibly being an alternative method to guide blood products~     transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG~     as a guide for blood products transfusion in cirrhotic patients undergoing invasive~     procedures.~   "
53093|NCT02362165|"~     Bortezomib-based triple-drug combination has greatly improved the response rate of multiple~     myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in~     clinical practice.Recent studies have found that cyclophosphamide, bortezomib,and~     dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized~     phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple~     myeloma patients.In this study, the investigators will compare the efficacy and safety of~     these two regimens using once-weekly subcutaneous injection of bortezomib.~   "
53399|NCT02358187|"~     The study will assess the immunogenicity, safety and preliminary clinical efficacy of the~     GAA/TT-peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas~     that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as~     one biologic regimen, but patients may not have received radiation to the index lesion~     within 1 year of enrollment.~   "
53098|NCT02362100|"~     The primary objective is to determine if a difference exists in functional outcomes, as~     measured by the Constant score, when comparing nonoperative management and locking plate~     surgical fixation of low-energy displaced proximal humerus fractures in the elderly~     population over a 2-year follow-up period. Secondary outcomes will include an assessment of~     the ASES score, the SF-36 quality of life score, complication rates, re-operation rates,~     radiographic time to union, radiographic malunion, hardware position and evidence of~     avascular necrosis or posttraumatic osteoarthritis .~   "
53099|NCT02362087|"~     The purpose of this study is to document what course of action physicians choose for their~     patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the~     greatest risk of TAPS by examining specific human genome markers such as single nucleotide~     polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic~     (hereditary) component.~   "
53100|NCT02362074|"~     The purpose of this study is to describe the impact of treatment with adalimumab on work~     related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated~     in Canada.~   "
53101|NCT02362061|"~     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These~     patients are then assigned to receive fertility treatment (ovulation induction, ICSI,~     intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to~     measure the junctional zone thickness and followed up after treatment to determine the rate~     of implantation.~   "
53102|NCT02362048|"~     ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic~     Pancreatic Cancer~   "
53103|NCT02362035|"~     This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib~     and pembrolizumab in hematologic malignancies.~   "
53104|NCT02362022|"~     Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic~     stability and analgesia for surgical prosedures. This prospective, randomized, double-blind,~     controlled study evaluates the effects of two different doses of morphine sulphate (0.1~     mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative~     analgesic requirements and side effects during total abdominal hysterectomy.~   "
53105|NCT02362009|"~     The purpose of the Fibroid Registry is to provide a comprehensive database that captures~     patient characteristics, clinical outcomes and pot-treatment quality of life measures for~     patients treated for uterine fibroids. This database will serve as a platform for future~     comparative effectiveness and other health services research studies.~   "
53106|NCT02361996|"~     It is a common understanding that patients with coronary heart disease are suffering, among~     others, from reduced myocardial perfusion. In order to increase (normalize) the reduced~     perfusion, when conventional approach failed, coronary bypass surgery, coronary vessel~     dilatation/stenting are performed. The similar situation with reduced myocardial perfusion~     may be found in patients with stenosis of the aortic valve, where aortic valve replacement~     may increase myocardial perfusion by left-ventricular remodelling. However, there is~     presently no method established to measure myocardial perfusion quantitatively and~     noninvasively before and after a therapeutic intervention.~      Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in~     ml/100g/min would strengthen the indication for specific therapeutic approach and enable an~     objective control of effectiveness of the applied therapy.~      Hypothesis:~      There is a measureable difference in quantitative myocardial perfusion values before (lower)~     and after (higher) interventional or surgical procedure.~      The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT~     256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:~        1. Before and after coronary bypass surgery~        2. Before and after coronary vessel dilatation/stenting~        3. Before and after aortic valve replacement.~      The investigators will not assign specific interventions to the subjects of these three~     groups. Therefore, the research is strictly observational.~      Design:~      Prospective study to measure quantitatively myocardial perfusion in the above mentioned~     three groups of patients with simultaneous control and registration of all essential,~     physiological determinants of myocardial perfusion immediately prior to each CT study. The~     CT myocardial perfusion measurements will be performed directly after the indication for~     intervention or surgery and on the last day before discharge from hospital.~      All the collected data (determinants) inclusively the CT-studies will be anonymised and~     archived on a local server. The investigators of the University of Medical Computed Sciences~     and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion~     measurements and all statistical analysis independently of the CT-studies performing~     physicians.~   "
53107|NCT02361983|"~     The aim of this study is to compare the success rate of lung isolation and time to~     accomplish a correct placement of the device between anesthetists with experience in~     thoracic anesthesia (defined as at least 4 years clinical practice experience as attending~     anesthetists in thoracic) and residents in training in thoracic anesthesia.~   "
53108|NCT02361970|"~     The purpose of the study is to evaluate the status and function of gamma delta T cells in~     peripheral blood of sepsis patients.~   "
53109|NCT02361957|"~     RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis~     is not yet fully understood. Studies suggest a relation between higher intestinal~     permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota~     might be the cause. Probiotics may restore the balance of the intestinal microbiota. In~     theory this could improve intestinal permeability and therefore reduce disease activity and~     maintain remission in patients with Ulcerative Colitis.~      OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture~     (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal~     permeability, microbiota composition, disease activity and inflammatory markers in~     ulcerative colitis.~      STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel~     arms.~      STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in~     remission or mild stage of the disease. For inclusion of the patients the Patient Simple~     Clinical Colitis Activity Index (P-SCCAI) will be used.~      INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two~     daily doses of 3 g of the placebo, containing only the carrier material (both produced by~     Winclove Probiotics).~      MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by~     several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood~     serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin~     and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure~     cytokine concentrations in serum and to analyse the microbial composition of the faecal~     samples using the HITchip. For the disease related quality of life the irritable bowel~     disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at~     three time points; t=0, t=6 and t=12 weeks.~   "
53110|NCT02361944|"~     The investigators will recruit and randomize 200 elective cardiac surgery patients to~     receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery~     to test the hypothesis that intraoperative physiologic oxygenation decreases the generation~     of reactive oxygen species, oxidative damage, and postoperative organ injury compared to~     hyper-oxygenation.~   "
53111|NCT02361931|"~     The investigative product, developed by Remedor, is a unique gel formulation that optimizes~     the administration of EPO to the wound bed. This novel formulation has been shown to~     stabilize EPO in the gel and to maintain its activity over long periods.~   "
53112|NCT02361918|"~     Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and~     TNF-alpha for anastomotic leakage in post-operative period.~   "
53421|NCT02357901|"~     This is a randomized, double-blind, placebo controlled, multisite study in male and female~     participants who are seeking treatment for opioid use disorder.~   "
53113|NCT02361905|"~     Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular~     than the surrounding myometrium, often with crowding and overlapping of nuclei. they often~     are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas.~     Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as~     hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer~     surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably~     related to degenerative changes induced by this treatment. Hypoechoic CLs should be more~     responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative~     ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to~     GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.~   "
53114|NCT02361892|"~     The uterine leiomyoma is the most common female benign disease.UPA seems to be most~     effective for the medical management of fibroids and could be place as preoperative adjunct~     to surgery but also as medical therapy to avoid surgery. No data have been published about~     the effect of UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral~     follicle count (AFC) or vascularization indexes during and after treatment. Considering that~     in young women of reproductive age (under 40 years old), desiring pregnancy, UPA has been~     proposed to avoid or postpone surgery, also in a long-term administration program, data~     about its effect on women ovarian reserve are urgently needed.~      For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow~     index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in~     terms of ovarian reserve modification.~   "
53115|NCT02361879|"~     The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about~     10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and~     infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH~     analogues are commonly used before hysteroscopic myomectomy to make surgery easier and~     safer, but they are expensive, have potential side effects and lack a robust evidence base~     to support this practice. Ulipristal acetate treatment was able and faster to control in 90%~     of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly~     improved quality of life and pain reduction.~   "
53116|NCT02361866|"~     The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of~     'GC1107' administered intramuscularly in healthy Adults.~   "
53117|NCT02361853|"~     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance~     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the~     host immune response are similar to those used by the developing placenta during normal~     pregnancy. In addition to the shared capacity for invading through normal tissues, both~     cancer cells and cells of the developing placenta create a microenvironment supportive of~     both immunologic privilege and angiogenesis.~      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that~     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived~     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow~     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells~     have been shown to play an essential role in mediating immune suppression in animal models~     of human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been~     found in peripheral blood, lymphoid organs and the tumor tissue itself. An increased~     population of IMCs was identified in patients with several tumor types. Accordingly, IMCs~     detected in the peripheral blood of such patients bearing express the common myeloid marker~     CD33 but lack markers of mature myeloid cells such as the MHC class II molecule HLADR.~      IMCs have been shown to actively promote tumor growth and metastasis by modulating the~     cytokine environment, and through vascular remodeling by promoting angiogenesis.~      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice~     and actively promote angiogenesis. These cells show striking similarity to IMCs that~     populate malignant tumors. Accordingly, human placentas are also infiltrated by a~     significant population of IMCs. Immunostaining of human placentas showed that IMCs comprise~     around 25% ( range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells~     and that this population is located close to blood capillaries. The investigators also~     demonstrated that immature DCs, cells originally described to regulate the adaptive immune~     response, also promote angiogenesis in models of choroidal neovascularization, endometriosis~     and tumors.~      Tho objective in this proposed study is to compare the abundance of IMC, DC, monocytes and~     neutrophils counts in blood samples of normal pregnancies: 1. in women in term active labor.~     2. In women not in labor. 3. In pre term labor.~      According to our previous findings, the investigators hypothesize that IMC's, monocytes and~     in active delivery (both term and pre term) will be lower than women without signs for~     labor. The investigators also hypothesize that DC's and neutrophils will be more abundant in~     active delivery (in term and pre term) than women without signs for labor.~      Experimental plan:~      Blood count will be collected from pregnant women who agree to participate in the research:~      The samples will be sent for the routine complete blood count in Hillel Yaffe hematologic~     lab and also will be analyzed for IMC's and DC's population in our lab using fluorescent~     immunostaining with specific monoclonal antibodies and flow cytometry.~      IMC's per total CD45 positive hematopoietic cells from the placental tissue will be analyzed~     using fluorescent immunostaining with specific monoclonal antibodies and flow cytometry .~     The specific location of these cells in the placenta will be identified within the placental~     tissue using Immunohistochemistry (IHC). The expression of pro angiogenic genes will be~     analyzed by RT PCR and Western blotting.~   "
53118|NCT02361840|"~     Shock is one of the five leading causes of income and mortality in emergencies. It generates~     a decrease in the availability of oxygen to the tissues, resulting in ischemia, pulmonary~     involvement and tissue reperfusion syndrome. This pathologies can trigger Syndrome of Acute~     Respiratory Distress (ARDS) and death.~      Troponin I (TI) has been reported as early marker for ischemia and mortality other than~     coronary syndromes in critical patients.~      Objective. Set the increase of TI as a predictor of ARDS in children with shock.~      Null hypothesis. Increase serum in children with shock predicts the onset of ARDS.~      Methodology. Prospective cohort type test diagnostic. Displays institutional. Sampling~     non-probability, consecutive inclusion. Calculation of the sample size: interval of~     confidence (IC) 95%, power - 80%; ratio non-exposed: exposed 2:1; n = 62.~      Inclusion criteria: informed consent signed by the parent; children admitted to pediatric~     emergency (PEU) 1 month to 14 years with shock requiring mechanical ventilation.~      Exclusion criteria: intake of toxic (TI value increment per will), ≥3 concentrated~     erythrocyte transfusion or plasma prior to entering PEU.~      The investigators call exposure to the increase of TI≥0 05ng/ml and event to the development~     of ARDS. Determine TI value in plasma serum in the first 24 h, through Enzyme Immunoassay~     for the Quantitative Determination of Cardiac-Specific Troponin-I in Human Serum (cTnI~     ELISA), (reported as cardiac triage). Monitoring for 7 days.~      Study was approved by Hospital Ethics Committee (Research record 003/12)~   "
53119|NCT02361827|"~     To date, several studies have been done to explore the relationship between Vitamin D level~     and IVF outcome; however, the results are controversial. Sample sizes in these studies~     mentioned above were relatively small. In addition, there are no prospective cohort studies~     in this field. Thus, here the investigators carry this prospective observational cohort~     study to demonstrate the relationship between vitamin D level and IVF outcome.~   "
53120|NCT02361814|"~     The objective of this pilot study is to gain observational insight into potential preventive~     features of amniotic membrane transplantation in the adhesion formation after flexor tendon~     repair.~   "
53121|NCT02361801|"~     Inotropic agents are usually administered in the postoperative period after cardiac surgery.~     In most cases, dobutamine is administered routinely, for the probable occurrence of~     myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal~     evidence of altered tissue perfusion.~      Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the~     perioperative period. However, the use of inotropic agents may be associated with adverse~     events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the~     imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus~     tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.~      This study is a non-inferiority clinical randomized study aiming to compare the use of~     dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a~     restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output~     syndrome associated with altered tissue perfusion). Our primary hypothesis is that the~     restrictive use of dobutamine is as safe and effective as the liberal one.~   "
53133|NCT02361645|"~     The purpose of this study is to assess vitreous concentrations of nonsteroidal~     antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before~     vitrectomy.~      A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the~     beginning of the surgery before infusion with balanced salt solution. Samples were~     immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked~     fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase~     liquid chromatography mass spectroscopy system. The minimum quantification limit for~     ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations~     were determined using a commercially available competitive enzyme immunoassay kit (R & D~     Systems, Minneapolis, MN).~   "
53134|NCT02361632|"~     The intention of this study is to determine wether coffee added milk change gastric volume~     in comparison with gastric volume after drinking black coffee~   "
53122|NCT02361788|"~     Background:~      Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period~     (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced,~     which is caused by a high level of bilirubin in the blood. In some neonates the level of~     bilirubin increases to a level that can cause braindamage or even death. There are different~     causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and~     prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with~     phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further~     investigations needs to be done.~      Objectives:~      Primary objective:~      To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age~     of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border.~      Secondary objective:~        -  Establishing the incidence of neonatal hyperbilirubinemia~        -  Determine the risk factors for the development of neonatal hyperbilirubinemia~        -  Determine the incidence of prolonged neonatal jaundice~        -  Determine the neurodevelopmental outcome, at the age of 6 and 12 months~        -  Determine the body composition, using air-displacement plethysmography, at birth, 1, 2~          and 3 months of age~        -  Determine the incidence of anaemia and illness episodes during the first year of life~        -  Determine the incidence of helminthic infection at the age of one year~        -  Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the~          mothers and SMRU health care staff~      Research design:~      The study will conduct an exhaustive prospective descriptive study, all eligible newborns~     will be enrolled after obtaining the informed consent from their mothers. During pregnancy~     and delivery we will collect clinical data about the mother. At birth we will take umbilical~     cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first~     week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml),~     weight and ask questions about feeding and other practices. Based on the bilirubin results~     we will determine whether the neonate needs phototherapy. After the first week we weekly~     follow-up will be conducted and in case of visible jaundice we will measure the bilirubin~     level. If the neonate is still jaundiced after the age of 21 days we will further~     investigate the cause. In the infant period, until the age of one year, we plan to have~     monthly follow-up to assess the health and growth of the child and at the age of 3, 6 and 12~     months we will do a neurodevelopmental test.~      An improved understanding of the pathological processes contributing to the development of~     neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop~     improved management.~   "
53123|NCT02361775|"~     Level I randomized prospective outcomes study comparing two groups of patients. One group~     will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will~     receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with~     an infusion of 0.2% Ropivicaine post-operatively and a PCA.~   "
53124|NCT02361762|"~     The goal of the project is to better understand executive control—how children manage~     complex or conflicting information in the service of a goal. This skill has been linked to~     social and academic functioning in typically developing children. Executive control is often~     reduced in children with autism spectrum disorders, but it has not been a focus of~     treatment. This project will have the goal of determining whether computer-training tasks~     developed to enhance the executive control skills of preschoolers and school-aged children~     without autism are appropriate for children with ASD. The investigators do not yet know if~     this training is beneficial for children with ASD. In addition, because executive control~     has been found to relate to social knowledge and problem solving, the investigators will~     collect information with this type of task to measure possible effects of training.~   "
53125|NCT02361749|"~     Chronic idiopathic constipation is most common cause of Constipation in childhood with~     numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical~     options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin.~     Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of~     Idiopathic Constipation~   "
53126|NCT02361736|"~     Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be~     nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that~     the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary~     and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old~     patients with normal renal function during orthopaedic surgery.~   "
53127|NCT02361723|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-290 in patients with solid tumors.~   "
53128|NCT02361710|"~     The aim of this study is determining the affects of serum vitamin D levels to implantation~     and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer.~     Two groups will be identified according to the serum vitamin D levels on eFET transfer day~     and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared~     between those groups~   "
53129|NCT02361697|"~     This is a prospective, non-randomised, non-blinded, single center study of children and~     adolescents with multiple sclerosis and clinically isolated syndrome to detect differences~     or early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).~   "
53130|NCT02361684|"~     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy~     (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in~     Spanish population.~   "
53131|NCT02361671|"~     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition~     arising from a variety of pathological conditions. The ability to monitor ICP is a crucial~     aspect in the management of these patients. Currently, the diagnosis of whether ICP is~     elevated or not is determined either with clinical signs (headache, nausea and vomiting or~     visual disturbances) or from the changes in the preoperative neuroimaging modalities such as~     computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).~      Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam~     that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in~     the optic nerve sheath diameter (ONSD).~      The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients~     with intracranial pathology and to compare the changes in the ONSD before and after surgical~     intervention as well as between patients with and without clinical or radiological signs of~     increased ICP.~   "
53132|NCT02361658|"~     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition~     arising from a variety of pathological conditions including traumatic brain injury (TBI),~     intracranial hemorrhage, subarachnoid hemorrhage and brain tumors. Monitoring the ICP is the~     most important aspect of the management of these patients. Recently, transorbital~     ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to~     be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath~     diameter (ONSD). Transorbital ultrasonographic measurement of ONSD appears to be a~     noninvasive, relatively inexpensive bedside examination for the diagnosis of raised ICP. The~     investigators aimed to determine the changes in ONSD with acute controlled changes in ICP in~     healthy volunteers. The controlled changes in ICP will be produced by manipulating the PCO2~     with the use of Respiract and jugular venous compression with the use of custom made neck~     collar.~   "
53422|NCT02357888|"~     The purpose of this study is to evaluate the reduction of craving and its time course after~     administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.~   "
53135|NCT02361619|"~     Four periods of oral dosing following overnight fasting (1. known metabolic probe drug~     cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2.~     dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail +~     dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between~     periods. Adverse events, haematology and clinical chemistry recorded.~   "
53136|NCT02361606|"~     Adolescents are often reluctant to receive psychological help. The investigators developed a~     web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes.~     The investigators aimed to examine the participation rate and outcomes on glycemic control~     and quality of life.~   "
53137|NCT02361593|"~     The aim of this study is to evaluate efficacy and safety of transparent cap-assisted~     endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.~   "
53138|NCT02361580|"~     Primary null hypothesis:~      • Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS~     [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after~     injury.~      Secondary null hypotheses:~        -  Keeping a personal diary has no effect on avoidance of painful activities (assessed w/~          PROMIS pain interference) 8 weeks after injury.~        -  Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS~          depression) 8 weeks after injury.~        -  There are no factors associated with upper-extremity disability 8 weeks after injury.~   "
53139|NCT02361567|"~     Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of~     discharge following mild to moderate pain risk surgery. The following will be assessed: 1)~     Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)~     Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat~     opioid prescription. It is expected that both groups will have similar pain outcomes but~     those patients in the Percocet group will be more likely to seek a second prescription.~   "
53140|NCT02361554|"~     The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of~     the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant~     schizophrenia. There is a subset of patients with schizophrenia who continue to have~     persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple~     adequate medication trials with antipsychotic medications including clozapine. There are~     currently no available treatments for such patients who generally have poor function and are~     chronically disabled, unable to work, live independently or have meaningful social~     relationships. Neuroimaging studies in patients with schizophrenia have revealed information~     about pathological neural circuits that could be suitable targets using deep brain~     stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase~     clinical trials in other psychiatric disorders.~      This pilot study will investigate the use of DBS in treatment-resistant schizophrenia~     subjects who have exhausted all other therapeutic alternatives but continue to have~     persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in~     patients with schizophrenia. The method will be similar to that used in subthalamic nucleus~     stimulation in patients with Parkinson's Disease. However, the electrode will be advanced~     slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the~     intention of causing local inhibition of SNr outflow resulting in disinhibition of the~     mediodorsal nucleus of the thalamus (MD). Hypofunction of the MDN has been implicated in the~     pathophysiology of schizophrenia in post-mortem as well as multiple structural and~     functional imaging studies. Evidence suggests that dysfunction of the MD is implicated in~     both positive and cognitive symptoms (such as working memory impairment) in schizophrenia.~     Frequent monitoring and clinical assessment with psychiatric scales will be used to monitor~     treatment response.~   "
53141|NCT02361541|"~     Hepatitis C (HCV) is an important global public health problem, disproportionately affecting~     HIV positive populations. Asia and Africa account for most of the co-infection burden, but~     access to HCV screening and treatment is still very limited. It is expected though, with the~     recent therapeutic advances and increasing global advocacy efforts, that HCV treatment~     should become a feasible option in the near future.~      Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest~     HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the~     prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the~     severity of liver disease. The researcher will also explore the performance of simple blood~     tests/panels as predictors of significant fibrosis and/or cirrhosis.~      Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH~     will be proposed HCV testing during their next HIV follow-up consultation, following the~     latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical~     examination will focus, additionally to routine practice, on presence of general and HCV~     liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and~     tests for liver function such as Hepatitis B surface antigen (HbsAg) .~      During the following routine HIV follow-up consultation, the results of HCV testing will be~     explained to the patient. If the patient is HCV negative, his/her study participation ends~     here. If currently infected with HCV, the clinician will repeat the HCV liver-disease~     (extra-hepatic & hepatic) related anamnesis and clinical examination, and prescribe~     additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests,~     liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and~     liver stiffness measurements.~   "
53142|NCT02361528|"~     The concept of acquired immunodeficiency after a first severe infection in the ICU is widely~     described in the literature. There is a dual risk: increased mortality and increased~     secondary infections. Several approaches of immunostimulatory treatments have been proposed~     in the literature. The treatment proposed by this study consists of the administration of~     Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely~     used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in~     Germany in 2009.~      The main objective is to measure the incidence of ICU-acquired infections in 2 groups of~     patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3~     from a severe sepsis or septic shock and presenting a sepsis associated immunodepression.~     The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human~     Leucocyte Antigen DR)with a threshold of less to 8000 sites.~      Our hypothesis is that the number of secondary infections (primary endpoint) will be~     significantly reduced in the treated group.~   "
53143|NCT02361515|"~     The present randomized, open, multicentric Phase II trial, in parallel groups with two arms~     of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to~     treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space~     between the prostate and the rectum to preserve the rectal-wall from high doses of~     irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2~     induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a~     stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after~     an injection of hyaluronic acid between the rectal wall and the prostate.~      Ninety-six patients and 9 centers are included in the protocol.~   "
53144|NCT02361502|"~     The proportion of male patients who participated in the phase III study of mirabegron was~     about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients~     have limits. For this reason, this study will assess the efficacy and safety of mirabegron~     in Korean male OAB patients.~   "
53146|NCT02361476|"~     Clonidine is widely used off-label in children for several indications. Clonidine is used~     for treatment and/or prevention of postoperative agitation in children anaesthetised with~     Sevoflurane. The investigators don´t have solid evidence for the effect and the~     investigators don´t have data for characterization of the pharmacokinetic profile among~     age-groups for children 1-6 years.~      In this study the investigators want to investigate if IV Clonidine administered at the end~     of surgery can prevent/reduce postoperative agitation. Secondary outcomes include~     measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.~   "
53147|NCT02361463|"~     Laparoscopy training programs with virtual reality simulators are widely used before new~     surgeons are allowed to operate on patients. Laparoscopic surgery results in shorter time to~     recover, less surgical trauma and thereby a shorter stay at the hospital compared with open~     surgery. However, it is more difficult to learn laparoscopic surgery, than open surgery, in~     part because surgeons have to work in a 3-dimensional space, through a 2-dimensional~     interface on a screen. This results in loss of depth perception and therefore a higher~     visual and cognitive load. This trial examines if using 3D vision instead of 2D vision on~     the laparoscopic virtual reality simulator reduces the time to reach proficiency, by~     decreasing the cognitive and visual load during practice on a Virtual Reality Simulator.~   "
53148|NCT02361450|"~     Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the~     embryonic neural tube, leading to serious malformations of the nervous system. Caudal~     neuropore malformations almost always lead to sensory-motor deficits (including complete~     paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological~     dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).~      The purpose of the study is to assess the efficacy of retrograde colonic irrigation~     associated with usual care (medical treatments, patient education) on anorectal dysfunction~     (incontinence and/or constipation), compared to usual care only.~   "
53149|NCT02361437|"~     This study is designed to evaluate if Vasculera, a marketed medical food product, will~     improve the rate and extent of healing of diabetic ulcers.~   "
53150|NCT02361424|"~     The purpose of this study is to assess the safety and efficacy on cognitive impairment and~     functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen~     at low dose) in patients with mild Alzheimer Disease.~   "
53151|NCT02361411|"~     The purpose of this study is to~        1. Early identify patients based on clinical manifestation, imaging, gene and histology,~          explore diagnostic tools~        2. get gene repertoire of Chinese~        3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease~          history, and exploring prognostic factors of hemorrhage in CAA patients~   "
53152|NCT02361398|"~     The investigators conducted a pilot study to compare the effect of Positive End Expiratory~     Pressure(PEEP) setting guide by the highest on oxygenation and by lung electrical impedance~     tomography(EIT) on survival in subjects with severe Acute Respiratory Distress~     Syndrome(ARDS).~   "
53153|NCT02361385|"~     The importance of the detection of early inflammatory arthritis is recognised as being~     essential to the prevention of permanent joint damage. Furthermore, drug development in~     inflammatory arthritis is in increasing need of imaging that is able to sensitively and~     accurately detect and quantify inflammation in a reproducible and objective manner. There is~     an increasing body of evidence to support the role of PET-CT for these indications. The PET~     tracer 11CPBR28 is specific to the translocator protein (TSPO) highly expressed on activated~     macrophages. In this proof of principle study, the investigators aim to ascertain whether or~     not the PET tracer 11CPBR28 is taken up in inflamed joints. The investigators also aim to~     explore the significance of TSPO to inflammatory arthritis, through blood and joint lining~     samples.~   "
53154|NCT02361372|"~     In a controlled, parallel, double-blind intervention study over 6 months, the investigators~     investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium~     bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and~     compared them with CaCO3 alone without kefir supplements. Bone turnover markers were~     measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD~     values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray~     absorptiometry (DXA) at baseline and at 6 months.~   "
53155|NCT02361359|"~     Psychologic status is associated with poor outcome after joint arthroplasty and perhaps~     chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific~     disorders or pain-related beliefs that contributed to chronic pain should be identified. We~     therefore determined whether specific psychologic disorders (depression, anxiety disorder)~     or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic~     pain after joint arthroplasty for osteoarthritis.~   "
53156|NCT02361346|"~     This Phase I, multiple ascending dose study will seek to enroll subjects with progressive B~     cell non-Hodgkin's lymphoma with measurable disease (lesion > 1.5 cm) (including SLL) OR~     relapsed/refractory B-cell CLL who have received standard treatment with at least one~     anti-CD20 antibody (e.g.; rituximab, ofatumumab)) containing front-line regimen that~     resulted in initial response, followed by relapse/recurrence and who are not eligible for~     any further approved biologic therapy, chemotherapy and/or autologous stem transplantation~     and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit~     from any therapy of higher priority by Investigator assessment.~   "
53157|NCT02361333|"~     The purpose of this study is to determine whether a teaching intervention can help increase~     the use of remote monitors in patients with implantable cardioverter defibrillators.~   "
53158|NCT02361320|"~     The goal of this study is to learn if computed tomography (CT) scans can help researchers~     predict how patients with pancreatic cancer may respond to chemotherapy.~   "
53159|NCT02361307|"~     The outcomes of ADL training in stroke patients depend on multifactors and essential~     practical point is cooperation plus effective communication between occupational therapist~     and nurse.~   "
53160|NCT02361294|"~     The study is designed to evaluate the role of platelets and immature platelets in the~     ethiopathology of deep venous thrombosis and pulmonary embolism.~   "
53423|NCT02357862|"~     The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on~     the geometry and the function of the tricuspid valve complex.~   "
53161|NCT02361281|"~     Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath,~     chest pain and reduced lung function. Suffering from these diseases has a very negative~     effect on the quality of life. When people are suspected of having sarcoidosis various~     markers in the blood are measured. Ultimate diagnosis, however, always requires invasive~     techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a~     new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for~     the patient.~      Such a new diagnostic tool might be found in examining the exhaled air of patients, which~     contains a complex mixture of so-called volatile organic compounds (VOCs) that are the~     result of damaging processes that occur in the lung. Determining the VOC profile in the~     breath can be used as a biomarker, or biological indicator, of those damaging processes. In~     other words, searching for unique VOC profiles in the breath of sarcoidosis patients might~     lead to the development of a diagnostic tool that only uses their exhaled breath.~      The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of~     this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a~     previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the~     current study.~   "
53162|NCT02361268|"~     The purpose of this study is to compare the effects of intra-dialysis yoga to an educational~     program among patients with end-stage renal disease. The investigators hypothesize that yoga~     as compared to the educational program will significantly improve quality of life.~   "
53163|NCT02361255|"~     Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically~     indistinguishable and DIP sometimes represents unmasking of underlying PD. The objective of~     this study is to determine the relationship of underlying Parkinson's disease (PD) to the~     incidence and clinical outcome in DIP using non-motor assessments as a marker for~     nigrostriatal degeneration.~      Research Design: This is a nested case-control design to investigate risk factors associated~     with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal~     (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.~      Methodology: We will examine objective olfactory function (via objective olfactory testing),~     other non-motor symptoms of PD (via standardized validated questionnaires), and motor~     findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30~     subjects) compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients~     with persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort~     followed prospectively after a change in AP treatment. Additionally, in patients where it~     was performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a~     marker of nigrostriatal integrity examining the ability of qualitative and semi-quantitative~     analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also~     measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and~     examine their relationship with clinical and radiologic status.~   "
53164|NCT02361242|"~     PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03~     protocol) and is designed for the descriptive analysis of patients with mild AD who are~     exposed to PXT00864 over an additional 24-week period.~   "
53165|NCT02361229|"~     It's known that organ transplant recipients with long-term drug-induced immunosuppression~     have a increase of the life-time incidence of squamous cell carcinoma. This study will~     analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the~     association with exposure to immunosuppressive and antiinfective drugs and other parameters~     like age or gender of organ transplant recipients.~   "
53166|NCT02361216|"~     The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for~     actinic keratosis applied to large treatment areas once daily for three consecutive days on~     face, scalp or chest.~   "
53167|NCT02361203|"~     The purpose of this study is to determine whether aerobic exercise can enhance the effects~     of exposure therapy treatment for fear of heights.~   "
53168|NCT02361190|"~     The proposed study will test the effects of a fast-acting testosterone nasal spray on the~     fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using~     a double-blind randomized experimental design.~   "
53169|NCT02361177|"~     The investigators are interested in the impact of intranasal oxytocin in unethical behavior.~   "
53170|NCT02361164|"~     The primary objectives are to evaluate relationship between nasopharyngeal microbial~     colonization and the occurrence of AOM or pneumonia in infants.~   "
53171|NCT02361151|"~     The high rates of childhood obesity in the US demand innovative and cost-effective weight~     gain prevention tools; mobile applications (apps) represent one such solution. Using a~     randomized design, the mFIT study tests the effectiveness of using commercially available~     apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared~     to the apps and PA device plus a mobile website and theory-based family intervention that~     encourages increased parent-child communication about PA and healthy eating as well as~     family behavior change (Tech+, n=50 parent-child dyads).~   "
53172|NCT02361138|"~     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an~     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose~     study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in~     healthy subjects.~   "
53173|NCT02361125|"~     The goal of this clinical research study is to evaluate the effectiveness of ritalin~     (methylphenidate) taken on an as needed basis for the management of cancer related fatigue.~     The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers~     will also evaluate the level of fatigue throughout the day and any possible causes of~     fatigue.~   "
53174|NCT02361112|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of Pyrotinib in combination with~     capecitabine in patients with HER2 positive metastatic breast cancer:~      To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD)~     To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of~     Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for~     phase II study~   "
53424|NCT02357849|"~     We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with~     aripiprazole in 48 patients with attenuated positive symptoms at a level of at least~     moderate severity.~   "
53175|NCT02361099|"~     This is a study that evaluates an optimization of the monitoring of patients with lung~     cancer in order to extend the survival of patients by improving their quality of life and~     decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of~     the follow-up imaging also helps to reduce the cost of such monitoring. The main objective~     of this study is to evaluate the overall survival of patients.~   "
53176|NCT02361086|"~     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics~     and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17,~     in patients with castration-resistant prostate cancer (CRPC).~   "
53177|NCT02361073|"~     The event-related potentials may be different in patients with Takotsubo cardiomyopathy than~     in patients without Takotsubo.~   "
53178|NCT02361060|"~     Pulmonary complications are relatively frequent after surgery, and can be associated with an~     increase in morbidity and mortality. Although there are several causative mechanisms that~     can lead to postoperative pulmonary complications, alterations in the shape and motion of~     the chest wall are of primary importance.~      In the investigator´s institution the incidence of postoperatory hypoxemia defined as~     pO2/FiO2 <300 is over 20% for patients after major abdominal surgery.~      Observational and randomized clinical trials have demonstrated that incomplete neuromuscular~     recovery during the early postoperative period may result in acute respiratory events~     (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary~     complications.~      A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular~     block reversal was done with sugammadex had less chest X-ray pathological changes than those~     from an historical cohort reversed with neostigmine.~      The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia,~     between patients reverted with sugammadex or neostigmine may be more apparent with more~     sensitive techniques like spirometry or lung ultrasound when they exist.~      Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to~     detect alveolar consolidation in critical ill patients while chest radiography data are~     known to be imprecise.The investigator would like to explore the utility of LUS in~     postsurgical patients and the relationship between degree of hypoxemia and consolidation~     area.~      Objectives:~        1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved~          in the absence of residual neuromuscular block. Objective is to assess differences~          after reversal with neostigmine versus sugammadex in:~           • Forced vital capacity (FVC)~        2. Secondary objectives: To assess differences after reversal with neostigmine versus~          sugammadex in:~             -  Atelectasis size determined by lung ultrasound (Plannimetry)~             -  pO2/FiO2 <300 1 hour after surgery~             -  Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative~               atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.~      Hypotheses:~        1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as~          compared to NMB reversal with neostigmine.~        2. Atelectasis is common after major surgery. Size of atelectasis determined by lung~          ultrasound planimetry is lower one hour after sugammadex reversal as compared to the~          neostigmine group.~        3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared~          to the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in~          20% of patients after major abdominal surgery).~        4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray~          after major surgery.~        5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and~          decrease of FVC after surgery~   "
53179|NCT02361047|"~     This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a~     parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers~     of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.~   "
53180|NCT02361034|"~     This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly~     Subjects.~   "
53181|NCT02361021|"~     Evaluation of lung aeration during weaning from mechanical ventilation determined by~     electrical impedance tomography and lung ultrasound~   "
53182|NCT02361008|"~     The purpose of this study is to investigate the security and validity of transesophageal~     echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in~     treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.~   "
53183|NCT02360995|"~     The objective of this clinical research study is to evaluate clinical efficacy of Colgate~     Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash,~     and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis~     and dental plaque in adults in a six-week clinical study.~   "
53184|NCT02360982|"~     The aim of this study is to compare the risk factors and the incidence of delirium following~     orthopedic surgery under the general or regional anesthesia in elderly patients.~   "
53185|NCT02360969|"~     Strabismus is a common condition (4-6% of the population) . The screening and treatment is a~     public health issue. Indeed, beyond the disfigurement, this disease is very supplier of~     amblyopia which is definitive if it is not detected and treated early (before 6 years old).~      Initial treatment of strabismus is medical with orthoptic reeducation through penalization~     of the better eye in case of amblyopia or wearing optical correction in case of associated~     refractive disorder.~      The second step is the treatment of strabismus is the surgery, when medical treatment has~     not resulted in a recovery of the visual axes. The principle of surgery is to weaken or~     strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint~     deviation. The main difficulty of surgical treatment is to assess the amount of~     strengthening or weakening muscles to do in order to obtain the best result and for a long~     time.~      The investigators know that the postmortem anatomical position of the eyes is generally a~     slight elevation and divergence, but is inferior to the angle of divergence of the orbital~     axes. Curare and similar products which inhibit the nervous transmission at the~     neuromuscular junction, can be used to reproduce this situation in normal subjects.~      The sign of general anesthesia is then to evaluate the angle of strabismus when the patient~     is under deep general anesthesia and with a complete muscle relaxation, obtained only when~     curarised it. If one or both eyes are recovering under general anesthesia, strabismus is~     mainly due to dynamic changes and surgery limiting muscle play (wire operation) and~     sometimes one eye is justified. A combination of both is possible (down + wireless), guided~     by the importance of the sign of general anesthesia on two prominent eyes or one eye. This~     sign of general anesthesia is however less known and most poorly quantified in healthy~     subjects. Yet it seems very important to determine what is deviation in normal subjects~     after neuromuscular blockade, as his eye movement is also subject to mechanical factors and~     spastic. This would indicate whether the state of rectitude (no strabismus) is the result of~     a deviation at complete rest (appearing under general anesthesia) and corrected by spastic~     elements wakefulness or, in another case this righteousness is already present in the state~     of general anesthesia (due to static factors) and slightly modified by enlightenment.~   "
53186|NCT02360956|"~     The purpose of this study is to determine whether olmesartan medoxomil is effective in the~     treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume~     reduction in patients with coronary atherosclerosis detected by coronary CT~     angiography(CCTA).~   "
53187|NCT02360943|"~     The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is~     based on anticoagulants. During the last decade, all the randomized clinical trials~     evaluating these anticoagulants have included PE patients with an average age below 60~     years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.~      So the investigators want to perform a french multicentre prospective cohort of consecutive~     patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the~     validated and available anticoagulant treatments are authorized in this cohort~     (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and~     direct oral anticoagulants).~      This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and~     regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these~     anticoagulants in this older population. Using population approach modelling , the~     investigators will pay particular attention to the sources of PK/PD variability PK / PD such~     as genetic polymorphisms of P-glycoprotein and cytochrome P450.~      Using all these data , the investigators will try to identify significant risk factors for~     bleeding and venous thromboembolic events.~   "
53189|NCT02360917|"~     At Cedars-Sinai Medical Center, we have developed a novel curriculum for a 6-week~     psycho-educationally-based, cognitive behavioral program to help patients with subjective~     cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each~     series meets once a week for 2 hours for 6 weeks. The leading neuropsychologist covers~     material such as guided relaxation, behavioral strategies for automatic/negative thoughts,~     compensatory strategies for attention and memory, executive functioning, pacing, and~     balance. Each Haze series will be electronically delivered in a live format to our satellite~     site, The University of Kansas.~   "
53190|NCT02360904|"~     The primary aim of this study is to assess and compare change in QOL during chemotherapy as~     measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between~     patients receiving yoga and those not receiving yoga. Secondary endpoints will include other~     measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory~     (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and~     adherence to yoga and to chemotherapy treatment.~   "
53191|NCT02360891|"~     Amyotrophic lateral sclerosis (ALS) is a complex polymorph and devastating neurodegenerative~     disease. Although the pathophysiological mechanisms underlying the development of ALS remain~     to be fully elucidated, there have been significant advances in the understanding of ALS~     pathogenesis, with evidence emerging of a complex interaction between genetic factors and~     dysfunction of vital molecular pathways. However, the numerous randomized clinical trials~     (RCT) for ALS have failed to generate improved drug treatments. Biomarkers able to bring~     prognostic value and to distinguish the different endophenotypes of this polymorphic disease~     could help to better select clusters of patients in order to improve the RCT outcomes.~     However, little progress has been made in the development of viable diagnostic, prognostic~     and monitoring markers. This could be explained by common shortcomings, such as relatively~     small sample sizes, statistically underpowered study designs, lack of disease controls and~     poorly characterized patient cohorts. It is yet crucial that the investigators further~     develop and validate ALS biomarkers and incorporate these biomarkers into the drug~     development pipeline for ALS.~      The aim of the present study is therefore to determine the clinical, biological, imaging,~     and electrophysiological biomarkers of prognosis of survival without events (i.e. severe~     comorbidity, 24 hours of non invasive ventilation, tracheotomy). This is a prospective~     observational multicentric French study of a cohort of 1000 ALS patients.~      This large multimodal database will be open for international fruitful scientific~     collaborations.~   "
53192|NCT02360878|"~     We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose~     metabolism as well as gut and pancreatic hormone secretion.~   "
53193|NCT02360865|"~     1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are~     associated with endothelial dysfunction, and the endothelium plays an important role in~     regulating vascular tone, tissue blood flow, coagulation and the inflammation process.~     Although the specific causes of endothelial dysfunction remain unclear, physical inactivity,~     chronic systemic inflammation and smoking are all known to be associated with endothelial~     abnormality.~      2. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of~     blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore~     contribute to the exercise intolerance and skeletal muscle depletion seen in patients with~     COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is~     thus adapted to meet energy requirements. During physical activity, the sympathetic nervous~     system is activated (exercise pressor reflex), resulting in increased ventilation, heart~     rate and a redistribution of cardiac output from inactive to active tissues. The~     redistribution of cardiac output to the body organs is heterogeneous. Blood flow to~     skeletal, respiratory and cardiac muscle increases as exercise intensity increases, whereas~     blood flow to gastrointestinal, renal and reproductive tissues decreases. As blood pressure~     during exercise remains largely unchanged, the redistribution of blood flow is caused by~     changes in vascular conductance. These conductance changes are caused by an overall~     vasoconstriction induced by the increased sympathetic outflow of noradrenaline (NA), and a~     vasodilation of vascular beds supplying the working skeletal -, cardiac- and respiratory~     muscle.~   "
53194|NCT02360852|"~     This study will evaluate the safety, tolerability and influence on itching, bile acids and~     liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250~   "
53195|NCT02360839|"~     Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine~     needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and~     intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma)~     are often well characterized by cytology assessment of FNA-samples while others are not~     (such as GIST-tumors).~      This study is a part observational (early study phase) and part interventional study (late~     study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during~     a 10-year period on a tertiary endoscopy centre.~   "
53196|NCT02360826|"~     Anticipating an increased use of statins in children and adolescents, it is imperative that~     we understand the genetic and developmental characteristics affecting the pharmacokinetics~     and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric~     dosing guidelines from adult dose-exposure-response relationships fails to recognize the~     potential impact of growth and development in pediatric patients, which may have important~     clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic~     variation in the SLCO1B1 transporter is important for statin disposition and toxicity in~     adults. The ontogeny of SLCO1B1 during human growth and development has not been well~     characterized, and limited pediatric data indicate that the genotype-phenotype relationship~     in children is the opposite of that observed in adults. Therefore, investigating the~     relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response~     is key to determining the age at which the statin dose-exposure-response relationship mimics~     adults, and has important implications for other medications transported by the SLCO1B1~     protein.~      As the first step in this process, our specific aims for the current investigation are 1) to~     determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin~     and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with~     2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine~     if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC~     and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary~     aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and~     adolescents for each genotype group. These results will be utilized to determine the sample~     size necessary to adequately power future studies characterizing the role of ontogeny on~     statin disposition.~      The ultimate goal of this proposed investigation is to establish the role of genetic~     variation in key transporters on the dose-exposure relationship of two commonly used statin~     drugs in children. This study is the first step in a series of investigations aimed at~     determining the mechanisms behind variations in physiologic response, clinical efficacy and~     significant adverse effect risk that surround the statin drugs in children and adolescents.~   "
53425|NCT02357836|"~     The purpose of this study is to determine the pharmacodynamics effects of itraconazole in~     early-stage non-small cell lung cancer.~   "
54418|NCT02344823|"~     The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and~     portal hemodynamics in patients with liver cirrhosis.~   "
53197|NCT02360813|"~     This clinical trial tests the feasibility, effectiveness and patient satisfaction with~     cognitive remediation therapy for patients diagnosed with schizophrenia or schizoaffective~     disorder within a forensic hospital. It is hypothesised that patients receiving cognitive~     remediation therapy will have an improvement in cognitive performance, real world~     functioning, symptoms, violence risk and benefit more from additional psychosocial treatment~     programmes over time relative to patients receiving treatment as usual. Furthermore it is~     hypothesised that it will be feasible to carry out such a study and that patients will~     report high rates of satisfaction with cognitive remediation therapy. Finally it is~     hypothesised that differences on the effectiveness measures will be maintained at 6 month~     follow up after the end of treatment.~   "
53198|NCT02360800|"~     Bleeding after ascending aorta surgery is a common, unresolved and consequences-heavy event~     as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut~     before closing seems a promising technique to radically diminish bleeding.~      This study aims to verify this efficacy (expected goal -50% blood volume in chest drains)~     and possibly the consensual blood transfusion lessening.~   "
53199|NCT02360787|"~     The purpose of this study is to determine whether inclusion of almonds in a weight loss~     regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio~     of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive~     function.~   "
53200|NCT02360774|"~     The purpose of this study is to investigate the effect of canagliflozin, a medication~     approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in~     people with type 2 diabetes who are overweight or obese.~      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than~     absorb, glucose. Canagliflozin is also often associated with weight loss.~      The study population will generally be type 2 diabetics, ages 18-75 years old, who are~     overweight or obese.~   "
53201|NCT02360761|"~     The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm)~     early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is~     being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these~     trials is under-represented, as in most of the ongoing clinical trials. This study focuses~     on the elderly population of early stage lung cancer, and aims to investigate the outcome of~     lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer~     (NSCLC) in elderly patients.~   "
53202|NCT02360748|"~     The study proposes that addition of high protein plant based diet will improve serum albumin~     as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Peritoneal~     Dialysis. Patient will be provided additional food items to help improve their nutritional~     status.~   "
53203|NCT02360735|"~     Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease~     various forms of edema. This technique promotes reuptake of interstitial fluid along the~     pathways of the lymphatic system. This technique promotes healing, decrease swelling, and~     decrease pain.~   "
53204|NCT02360722|"~     This is a single- country, interventional, double-arm study involving Chinese Elderly~     subjects.~   "
53205|NCT02360709|"~     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8~     sirolimus-eluting stent system in the treatment of patients with de novo coronary artery~     lesions.~   "
53206|NCT02360696|"~     Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators~     have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children~     undergoing diagnostic endoscopy. Previous studies in children have shown positive response~     to montelukast with approximately 50% finding complete relief and 20-30 percent showing no~     response.~      There are a number of factors that have the potential to contribute to the observed~     variability in response to montelukast. These include variability in:~        1. systemic drug exposure (drug absorption, biotransformation and/or elimination)~        2. regulation of leukotriene biosynthesis~        3. cysteinyl leukotriene receptors and downstream mediators~        4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease~          classification, psychologic profile)~      In this study, the investigators propose to utilize biopsy specimens stratified by drug~     response to identify candidate gene expression modules that will be validated in a~     prospective study design. The overall goal of this program is to develop a signature of~     montelukast response that can be applied not only to eosinophilic gastroenteritis, but more~     generally to other diseases, such as asthma, where the drug is widely used with variable~     success.~   "
53207|NCT02360683|"~     This study identify preoperative predictors of response to subthalamic stimulation at 1~     year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter~     study French with standardized collection of clinical data , imaging and genetic .~      The investigators want to identify factors that predict the improvement of quality of life~     for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that~     improvement would be less likely to become zero to 3 or 5 years and question the indication~     of the subthalamic stimulation (risks and costs). This is part of a process of~     personalization of the therapeutic care that is of any interest to the subthalamic~     stimulation. It is a therapeutic option that could be dangerous if patient selection is not~     optimal , and expensive, if the benefit is not large enough to reduce the number of~     medications and hospitalizations medium term . In addition, it will quantify the improvement~     of quality of life in the longer term and harmonize national assessments .~   "
53217|NCT02360553|"~     Adolescents nowadays is having most of their times other than school hours spending on~     screen by playing games, watching the movies and surfing the internet. Thus, it was~     suggested that Internet-based interventions have the potential for establishing healthy~     dietary style and physical activity that may persist in adulthood and reduce the risk of~     chronic disease. Preventing adolescent obesity requires an attitude of willingness by~     adolescents to implement healthy behaviors. By providing the health related activities in~     website, it would help the adolescents to spend time on screen by having something which can~     benefit them and improve their knowledge and attitudes.~   "
53459|NCT02357368|"~     This is a prospective cohort study focusing on HIV negative women. The investigators want to~     learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate~     (DMPA), Etonogestrel impant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD)~     impacts the vaginal immune environment~   "
53208|NCT02360670|"~     Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled.~     Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with~     clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours~     of onset. Currently only a small proportion of patients who arrive in hospital within 4.5~     hours are treated. This is largely due to uncertainty about diagnosis and concerns about~     risk of bleeding associated with clotbusting medication. Patients with mild or improving~     symptoms in particular are often not treated because of uncertainty about relative risks and~     benefits. However, around one third of these patients go on to be significantly disabled.~     Routine CT scanning often does not show abnormalities in acute stroke (which take hours to~     become easily visible), and cannot show the extent or severity of blood flow changes in~     ischemic stroke.~      We wish to investigate the value of additional CT scanning that gives information on the~     blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking~     a randomised trial. Extra scans are done in the same scanner and involve some extra~     radiation, injections of a contrast dye, and some extra time to acquire process and~     interpret. The extra scans may allow better treatment decisions for patients by increasing~     diagnostic certainty and by better assessment of stroke severity. However, we do not know~     whether the potential gains from better selection justify the resources and potential~     treatment delays that are involved. We will investigate whether the proportion of patients~     given clotbusting drugs differs between the two scanning protocols; and whether the outcomes~     differ, using standard measures of disability. We will also investigate whether use of~     different scanner manufacturers' software affect interpretation of scans.~   "
53209|NCT02360657|"~     The purpose of this study is to determine the safety, tolerability and effect of~     JNJ-54861911 on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4~     weeks of treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia~     (ARAD) at the intended target dose range.~   "
53210|NCT02360644|"~     This study investigates the effect of vitamin D deficiency on drug metabolism and transport~     in patients with chronic kidney disease (CKD) and in healthy controls.~      The central hypothesis is that vitamin D concentrations independently affect metabolism and~     transport function in CKD patients. An over-arching goal of this proposal is to make drug~     therapies safer and more effective to reduce the significant morbidity and mortality in~     patients with CKD.~   "
53211|NCT02360631|"~     The purpose of this study is to examine whether or not providing Chantix (varenicline) will~     help African American smokers quit smoking.~   "
53212|NCT02360618|"~     A single arm, single center window of opportunity trial of using a combination of metformin~     and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are~     to undergo cystectomy. The study will assess the feasibility of conducting window of~     opportunity trials in invasive bladder cancer the drug combination's affects on a variety of~     important clinicopathologic variables.~      The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at~     12 months, and the study will be prematurely closed if fewer than 10 patients have been~     enrolled at that time. Patients will be administered 850mg of metformin twice daily along~     with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of~     invasive bladder cancer or at first visit following referral to the London Health Sciences~     Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment~     until the night prior to their operation in the absence of safety or tolerability concerns.~   "
53213|NCT02360605|"~     In the proposed project the investigators will evaluate two different follow-up approaches~     to improve low income patients' completion of initial and annual colorectal cancer (CRC)~     screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of~     this study is to compare the effectiveness of two distinct follow-up strategies to promote~     CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder~     (ATR) system. The investigators will adapt a successful intervention tested in the Health~     Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy~     intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the~     effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2.~     Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC~     screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both~     follow-up strategies to investigate implementation and barriers 4. Determine if the effects~     of either strategy vary by patients' literacy skills. 5. Explore patient characteristics~     associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time~     between study arms.~   "
53214|NCT02360592|"~     This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to~     evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and~     hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B~     patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3~     groups to receive different antiviral treatment.~   "
53215|NCT02360579|"~     Prospective, single-arm interventional study evaluating autologous tumor infiltrating~     lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy~     preparative regimen for the treatment of patients with metastatic melanoma.~   "
53216|NCT02360566|"~     Prior research has shown that people with psychotic illnesses, like schizophrenia, who make~     sense of and meaningfully integrate their psychotic experiences into their life story are~     more likely to recover from their illness. This process of developing a coherent narrative~     seems especially relevant for young people who are experiencing their first episode of~     psychosis. There is a need for interventions that can help facilitate the formation of~     recovery-oriented narratives, particularly in the early stage of illness. Participatory~     video is a group process that involves the facilitated creation of short documentary-style~     videos in which individuals are supported to reflect on and tell their personal stories.~     Although it has been used to foster self-identity, self-empowerment and give voice to a~     variety of marginalized and stigmatized populations, its use and evaluation as a clinical~     intervention has been limited.~      The purpose of this study is to determine whether the novel use of participatory video~     facilitate narrative development and promote recovery for individuals with early psychosis~     is an effective, feasible, and acceptable means of treating youth in the early stages of~     psychotic illnesses. Although the current study is hypothesis generating in nature, the~     investigators are expecting that participating in the Participatory Video intervention will~     result in improvements in narrative development, symptoms, self-perceived recovery,~     self-esteem, self-stigma, social functioning and hope. Additionally, the investigators~     expect that Participatory Video intervention will prove to be acceptable to participants and~     a feasible intervention for early psychotic disorders.~   "
55727|NCT02327715|"~     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive~     pregnant HBsAg positive patients in prevention of HBV vertical transmission. Single group~     patients were enrolled to receive emtricitabine till 24 weeks after delivery.~   "
53218|NCT02360540|"~     PERC rule was created to rule out pulmonary embolism (PE) without further exams, with~     residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as~     north-American. In European high PE prevalence population, it has been showed that PERC rule~     used alone or associated with low clinical probability assessed by revised Geneva score~     (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule~     with implicit clinical probability (gestalt) could allow the use of the PERC rule.~      PERCEPIC, an observational prospective multicenter study performed in France and Belgium,~     will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary~     outcome will be the rate of thromboembolic events or death related or possibly related to PE~     in patients with low implicit clinical probability and negative PERC rule (8 criteria~     absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to~     consider PERC rule as safe in this combination.~   "
53219|NCT02360527|"~     A clear association between type 2 diabetes (T2D) and Alzheimer's disease (AD) has been~     reported. This association is independent of vascular impairment, and therefore, it could be~     attributed to neurodegeneration triggered or accelerated by diabetes itself. At present~     there are no methods to identify T2D patients at risk for developing AD. The retina shares~     many features with the brain and, therefore, has been suggested as an easily accessible way~     of examining pathology in the brain. In fact, many patients with AD present retinal~     abnormalities. However, the diagnosis of diabetes, a condition frequently associated with~     retinal neurodegeneration, has not been considered. On this basis, the final aim of this~     proposal is to identify diabetic patients at risk for developing AD based on the assessment~     of retinal neurodegeneration by means of non-invasive tests. Specific aims: 1) To compare~     the prevalence of morphological and functional abnormalities related to retinal~     neurodegeneration among three groups of T2D patients: patients with AD, patients with Mild~     Cognitive Impairment (MCI) and patients without AD or MCI. 2) To assess whether the retinal~     neurodegenerative features are related to severity of AD. 3) To explore whether the combined~     retinal neurodegeneration in diabetic patients with AD has a different functional and/or~     morphological pattern in comparison with neurodegeneration secondary to diabetes alone.~     Methods: Case-control study. Retinal neurodegeneration will be assessed by mutifocal~     electroretinogram (mfERG) and spectral domain optical coherence tomography (SD-OCT). The~     potential confounders will be considered in data analyses. Feasibility: A unique~     multidisciplinary consortium has been created in order to warrant the feasibility of the~     project Expected impact: This innovative approach will fill a gap that currently exist in~     the health care system and will reduce the economic burden associated with T2D patients with~     AD. In addition, this project would be the backbone for future prospective studies.~   "
53220|NCT02360514|"~     This study was aimed evaluate long-term immunity response by neutralizing antibody test of~     adults in high risk population of HFRS .~   "
53221|NCT02360501|"~     The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB)~     nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given~     to those patients in order to shrink the tumor volume and facilitate the following radiation~     therapy. Thus, in this study, the investigators use the combination of~     Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal~     carcinoma patients, in order to evaluate the efficacy and safety profiles.~   "
53222|NCT02360488|"~     The current study will test the effectiveness of a novel home-based telehealth system~     designed to improve motor recovery and patient education after stroke. A minimum of 124~     subjects (the number may be larger depending on the rate of subject dropout) with arm motor~     deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be~     randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic~     setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the~     subject's home via an internet-connected computer). The intensity, duration, and frequency~     of this therapy will be identical across the two groups, with subjects in both treatment~     arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a~     10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm~     motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor~     status is the focus here because it is commonly affected by stroke, is of central importance~     to many human functions, and is strongly linked to disability and well being after stroke.~   "
53223|NCT02360475|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     different formulations of a single intramuscular dose of GSK Biologicals' investigational~     RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.~   "
53224|NCT02360462|"~     This is a clinical trial that intend to determine if transcranial direct current stimulation~     (tDCS) is effective in the treatment of postoperative pain and in the anxiety level in the~     preoperative period of hallux valgus surgical treatment~   "
53225|NCT02360449|"~     The purpose of this study is to investigate whether a social initiation motivation~     intervention (SIMI) focused on training children with ASD to initiate to peers during~     structured play activities will result in more frequent initiations to typically developing~     peers during free play. The SIMI approach under investigation uses behavioral strategies~     based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with~     ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or~     a waiting list. Treatment will be provided for 8 weeks in the context of a weekly social~     skills group.~   "
53226|NCT02360436|"~     Analyis of the Glutathione Cycle in Children with Rett Syndrome~   "
53227|NCT02360423|"~     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8~     sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of~     patients with de novo coronary artery lesions.~   "
53228|NCT02360410|"~     The proposed study is a randomized controlled trial that compares the effectiveness of an~     electronic personalized health screening app incorporating motivational feedback (i.e.,~     Check Yourself) to usual care. The purpose of this study is to determine whether Check~     Yourself is more effective than usual care in reducing health risk behaviors and improving~     quality of care among adolescents receiving primary health care services.~   "
53229|NCT02360397|"~     The purpose of this study is to determine whether ranolazine has beneficial effects on~     cardiac ischemia through reduction of premature ventricular contraction burden.~   "
53311|NCT02359331|"~     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter~     pylori (H. pylori) therapies has been declined coincidentally.~      In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7~     days personalized therapy for H. pylori infection based on the results of antibiotics~     resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14~     days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the~     prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored~     therapy group.~   "
53230|NCT02360384|"~     Irritable bowel syndrome is common. Currently, it is a diagnosis of exclusion. There is~     increasing evidence of the importance of the microbiota in the pathophysiology of this~     disorder. However, it has been challenging to measure the activity of the microbiota in~     vivo as much of the GI tract is inaccessible. Fermentation by the microbiota occurs in the~     colon, a by product of which are short chain fatty acids. Measuring pH in the colon could~     potentially act as a surrogate marker of fermentation. The investigators are undertaking a~     randomised controlled trial in patients with IBS measuring the pH in the digestive tract~     using a wireless motility capsule at baseline and in response to dietary changes in patients~     with diarrhoea predominant IBS and in response to linaclotide in those with constipation~     predominant IBS to ascertain the effect of these interventions on the microbiota and~     clinical outcomes.~   "
53231|NCT02360371|"~     This study will evaluate the magnitude of individual differences that exist in human~     response to a blinded study medication.~   "
53232|NCT02360358|"~     A prospective, multicenter, randomised controlled phase II study in which patients with~     therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group)~     or with AS210 (control group) to determine the safety and relative efficacy of both~     products.~   "
53233|NCT02360345|"~     This is an open label, single-centre dose escalation phase 1 clinical trial of ONX-0801.~      The study will evaluate two schedules of ONX-0801 concurrently: once weekly and alternate~     week dosing, of repeated 28-day treatment cycles.~      The study will consist of two stages: the dose escalation phase, in which the recommended~     phase II dose will be determined; and the expansion phase, in which up to 30 patients will~     be treated at the recommended phase II dose and schedule to further support the design of~     subsequent trials of ONX-0801.~   "
53234|NCT02360332|"~     The aim of the research project is to conduct evidence-based research on a nationally known~     vocational rehabilitation (VR) service model (Project Search) for individuals with Autism~     Spectrum Disorders (ASD). This information may be useful to high schools and vocational~     rehabilitation agencies that endeavor to use evidence based practices to serve individuals~     with ASD.~   "
53235|NCT02360319|"~     The goal of this project is to show that the best possible option for preventing relapses in~     patients suffering from first episode (<1 year of anti-psychotic medication) or early phase~     (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing~     medication adherence. The study is designed to answer the question of whether the use of~     long-acting injectable (LAI) antipsychotics early in the course of treatment can break the~     cycle of frequent relapse that affects so many patients with early phase schizophrenia. The~     participating research sites (not individual patients) will be randomly assigned to either~     medication prescribed by their treating physician (with no restrictions) or to a regimen~     that involves a monthly long acting injectable antipsychotic. The sites will be assigned on~     a one to one basis to either of the arms taking into account types of patient population and~     geographical area. Patients enrolled in the study will participate in regular assessments~     either over the phone or in person and be followed for a period of 2 years. The primary~     outcome measure is time to first hospitalization.~   "
53236|NCT02360306|"~     Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used~     in the diagnosis of mediastinal and hilar adenopathy as well as in staging in lung cancer~     patients. Many studies have confirmed the utility of EBUS-TBNA with high sensitivity,~     specificity, and accuracy for the diagnosis of mediastinal and hilar adenopathy. 1-3 Less~     well reported has been the use of the EBUS bronchoscope to perform other procedures such as~     transbronchial biopsy (TBBx), endobronchial biopsy (EBBx), bronchoalveolar lavage (BAL) and~     airway brushings. While not well reported in the medical literature, anecdotal evidence~     supports these practices. The investigators propose a methodological evaluation of the full~     spectrum of procedures that have been performed and that are possible using an EBUS~     bronchoscope.~   "
53237|NCT02360293|"~     This project is Project three of a four project Prevention Coaching Lab CREATE grant~     entitled Transforming Prevention into Action aimed at effectively engaging patients and~     their families to improve their health and medical care.~      This project will test the feasibility and effectiveness of the prevention focused, internet~     mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and~     demographics of OEF/OIF Veterans.~   "
53238|NCT02360280|"~     About one-third of depressed patients will not get better after multiple antidepressant~     treatments. This situation put a high burden on patients with depression due to worsening~     quality of life and increasing health care costs. Difficult-to-treat depression might be~     even worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times~     higher than among the general US population. A breakthrough discovery happened in recent~     years when investigators found that one infusion from an old anesthetic named ketamine~     showed high efficacy and rapid antidepressant effect (sometimes within hours) but lasted~     only up to a week. The investigators propose to study if multiple infusions of ketamine can~     provide greater and longer antidepressant effects than one infusion. If that is the case,~     multiple infusions could be an alternative to relieve depressive symptoms that do not~     response to multiple antidepressant drugs.~   "
53239|NCT02360267|"~     The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment~     regarding the diagnosis and treatment of pediatric bipolar disorder to children and~     adolescents with any current mood state and/or children/adolescents who are offspring of a~     parent with bipolar disorder (BD) type I or II and their families.~   "
53250|NCT02360124|"~     This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects~     will be recruited from social centres for elders located in different districts in Hong~     Kong. Baseline clinical examination will be conducted by a single calibrated examiner in the~     social centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be~     randomly allocated into the three study groups and receive interventions accordingly.~     Follow-up examinations at 6-month intervals will be carried out to assess the clinical~     outcomes, i.e. whether new root caries has developed and whether the active root caries~     found at baseline have become arrested (remineralized and hardened) or not. Photographs of~     the arrested lesions will be taken to assess their colour. Results of this study will~     provide the much needed evidence to guide the dental professionals in Hong Kong and~     worldwide in deciding on the most appropriate intervention for the prevention and treatment~     of this common dental disease of the older adults.~   "
53240|NCT02360254|"~     Rationale. Degludec is a longer-acting insulin analog compared to glargine and detemir. In a~     fraction of type 1 diabetic patients, insulin glargine and insulin detemir may not achieve~     24h coverage, reflected by raising pre-dinner glucose levels when they are administered at~     bedtime. As up-titration of bedtime long acting insulin increases risk of nocturnal~     hypoglycaemia, this clinical problem can be addressed by an additional injection of in the~     morning. These type 1 diabetic patients may benefit from shifting from twice daily insulin~     glargine/detemir to once daily insulin degludec, which shows an extended activity over 24h,~     up to 48h.~      Objective. To evaluate the effects of shifting from twice daily insulin glargine or detemir~     to once daily insulin degludec on HbA1c and glucose profiles in type 1 diabetic patients~     during a period of 3 months.~      Study design. Observational analytic prospective study. Protocol. Type 1 diabetic patients~     on twice daily insulin glargine or detemir (because of pre-dinner hyperglycemia due to~     supposed glargine/detemir coverage <24h) will be identified and enrolled. During a run-in~     period of 1 week, the investigators will collect data on HbA1c values as IFCC/DCCT-aligned~     and on glucose profiles using glucose meters. Patients will undergo a 7-14 day continuous~     glucose monitoring before and eventually during (additional 7-14 days) the shift from twice~     to once daily basal insulin. Patients will be re-assessed 12 weeks after initiation of~     insulin degludec with determination of HbA1c and 7-14 day continuous glucose monitoring.~   "
53241|NCT02360241|"~     This study aim is to evaluate the needle positioning precision, compared to the real path~     planned by the physician on healthy voluntaries, by positioning a fictional needle, without~     inserting it.~      Additionally, this study will evaluate:~        -  the robot precision,~        -  the robot detection robustness,~        -  the software and device ergonomics,~        -  the device security.~   "
53242|NCT02360228|"~     Investigating the effects of non-invasive transcranial current stimulation as a treatment~     for auditory hallucinations in patients with schizophrenia.~   "
53243|NCT02360215|"~     This randomized phase III trial compares memantine hydrochloride and whole-brain~     radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in~     patients with cancer that has spread from the primary site (place where it started) to the~     brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis.~     Unfortunately, the majority of patients with brain metastases experience cognitive (such as~     learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive~     function by binding to and inhibiting channels of receptors located in the central nervous~     system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Using radiation techniques, such as intensity modulated radiotherapy to avoid the~     hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help~     limit the radiation-induced cognitive decline. It is not yet known whether giving memantine~     hydrochloride and WBRT with or without hippocampal avoidance works better in reducing~     neurocognitive decline in patients with brain metastases.~   "
53244|NCT02360202|"~     Clinical observation frequently shows a paradoxical effect of topical corticosteroids in~     charge of a sudden melting of edema in the first days of treatment, which could be due to~     mobilization of extracellular. No study has shown the value of this measure in patients~     treated with topical steroids. This uncertainty, coupled with the observation of the~     paradoxical effects of topical steroids on edema are some patients that despite the systemic~     absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.~   "
53245|NCT02360189|"~     Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR)~     attendance and uncover mechanisms of CR non-attendance.~      Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level,~     comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence~     are predictors of CR attendance.~      Hypothesis b: The expected social gradient in CR attendance is explained partly by~     differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and~     distance to the rehabilitation clinic.~   "
53246|NCT02360176|"~     Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the~     reference method in terms of complications using a score of morbidity and mortality at 6 and~     24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis,~     splenic lesions, hernia, residual gastric pouch and mortality~   "
53247|NCT02360163|"~     The purpose of this study is to reduce, by using the ultrasound guided technique, the minor~     surgical procedures that might be required to deliver fluids into the blood of critically~     ill patients simply because the patients' veins cannot be located through the manual~     technique.~   "
53248|NCT02360150|"~     The purpose of this study is therefore to show that associated with cardiac angiography~     echocardiography, in myocardial seen late, would provide the information necessary for the~     decision revascularization, in a timely manner.~      This would allow the patient to avoid duplication of tests including risk related to~     coronary angiography (bleeding complications, stroke ...) and those related to the~     implantation of coronary stent (stent) without expected earnings in case of non-viability .~     This would also reduce the length of hospital stay and costs due to numerous reviews.~   "
53249|NCT02360137|"~     Atherosclerosis is the most common cause of stroke. The aims of the project are to compare~     the visual and digital analysis of sonographic images of atherosclerotic plaque in carotids~     in vivo, in vitro and with a histological composition of the plaque obtained from patients~     indicated to carotid endarterectomy, to compare the characteristics of symptomatic and~     asymptomatic atherosclerotic plaques and, subsequently to verify a hypothesis that~     ultrasound can identify the sonographic plaque characteristics associated with an increased~     risk of plaque progression and of ischemic stroke (unstable plaque) in patients with carotid~     atherosclerosis. Identifying of the sonographic characteristics of unstable plaque will~     allow to improve indication criteria for carotid endarterectomy or stenting and also~     potential changing of a drug therapy in patients with unstable plaque in the future. Cost~     efficiency and availability of duplex ultrasound equipment may enable to improve diagnosis~     of unstable plaque using this new plaque characteristics evaluation in the majority of~     patients with carotid plaques.~   "
53251|NCT02360111|"~     This is a pilot study which will be done in a small number of patients. The purpose of this~     study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide~     - after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal~     kidney function. GVHD is one of the most common complications of a stem cell transplant .~   "
53252|NCT02360098|"~     Smooth emergence (wake up) from anesthesia is an important consideration in patients~     undergoing neurosurgical procedures as blood pressure changes associated with violent~     emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence~     should also be quick so that patients' neurological function can be assessed at a timely~     manner. Pattern of emergence from anesthesia is poorly investigated and understood. Epilepsy~     surgery involves resecting epileptogenic tissues including limbic structures which may be~     functionally normal. Hence the emergence process can be complicated in patients having~     diseased limbic structures or those having therapeutic removal of limbic structures as in~     epilepsy surgery. Limbic structures are responsible for memory, language and executive~     function and hence loss of some of these higher functions is to be expected in the~     postoperative period. Preoperative neuropsychological assessments are often used to predict~     their risk for postoperative loss of higher functions and behavior changes. In our~     experience the investigators have seen that there is a spectrum of emergence characteristics~     in patients undergoing temporal lobectomy that can vary from dangerously agitated patient to~     much sedated, unarousable patient. Delirium and agitation can be dangerous and have serious~     consequences for the patient such as injury, increased pain, hemorrhage, self-extubation and~     removal of catheters requiring physical or chemical restraint. On the other hand the~     unarousable patient may pose dangerous airway complications and limit neurological~     assessment in the immediate postoperative period. Hence it is essential to have a clue about~     post anesthesia emergence behavior in patients having epilepsy surgeries. The aim of this~     study is to look at the pattern of emergence from anesthesia after epilepsy surgery and to~     determine if preoperative neuropsychological assessment help predict the pattern of~     emergence in patients undergoing anterior temporal lobectomy and amygdalohippocampectomy.~   "
53253|NCT02360085|"~     Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of~     the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic~     dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is~     important to maintain adequate mean arterial pressure in order to perfuse the spinal cord~     and prevent cord ischemia. Heart rate variability, the physiological variations of the~     differences between heart beats, has been used to diagnose autonomic dysfunction. In~     patients with cervical myelopathy it may enable the anaesthetist to predict hypotension~     thereby allowing for early treatment and prevention of spinal cord ischemia.~   "
53254|NCT02360072|"~     This is a prospective observational study , to clarity the characteristics of airway~     inflammation, airway reactivity and airway resistance in rhinitic children with or without~     asthma and to explore the possible predictors in the progression of allergic rhinitis to~     asthma.~   "
53255|NCT02360059|"~     The goal of this clinical research study is to learn if metformin can help to control nerve~     damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel~     in patients with breast cancer.~      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug, but it is not designed to treat any disease or illness. It is designed~     to be compared with a study drug to learn if the study drug has any real effect.~   "
53256|NCT02360046|"~     This study aims at assessing the effect of today's standard of hydrocortisone dosage versus~     previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL~     and IHCL) after a standardised fat load followed by a short-term aerobic exercise in~     patients with corticotropic pituitary insufficiency.~   "
53257|NCT02360033|"~     Goals of the study:~      Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy~     (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the~     time, did not include anxiety disorders. According to the 2007 joint methods paper of the~     WBP and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be~     three randomized-controlled trials (RCT) for anxiety disorders. These studies are available~     now but lack explicit details about the clinical significance of the reductions they show in~     social anxiety symptoms. This project is funded by the German Association for Systemic~     Therapy, Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie,~     Beratung und Familientherapie: DGSF).~      Study design:~      The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility~     of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety~     Disorders (SAD) in 32 patients.~   "
53258|NCT02360020|"~     Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and~     >90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting~     coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses~     characterised by better mechanical properties than traditional DES. This is a prospective,~     non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS~     DES in severely complex coronary lesions in real-world clinical practice.~   "
53259|NCT02360007|"~     Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence,~     current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an~     alarming number of clinics have extensive waitlists for treatment slots. Patients can remain~     on these waitlists for years, placing them at elevated risk for illicit drug use, criminal~     activity, infectious disease, overdose and mortality during this period. These delays in~     treatment access represent a significant barrier to the widespread delivery of effective~     opioid treatment, and there is a critical need to develop creative new approaches for~     mitigating these delays. Our overarching goal in this application is to develop a novel~     Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our~     integrative treatment package includes five key components, each strategically chosen to~     maximize patient access to pharmacotherapy for opioid dependence while minimizing~     nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth~     clinical support delivered via Interactive Voice Response, Automated random call-backs for~     urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The~     Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is~     to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in~     which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to~     receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants~     who have not entered treatment by Week 12 will be offered the opportunity to cross over to~     IBT at that time, contributing additional within-subject data with which to evaluate the~     efficacy of the IBT intervention. The proposed research is innovative in several important~     ways: By facilitating the eradication of waitlists for opioid treatment, it represents a~     significant departure from the status quo and stands to produce a fundamental shift in how~     treatment of opioid dependence is conceptualized and delivered. The IBT components are~     highly novel, both individually and as an integrative interim treatment package for opioid~     dependence. This study will be the first to investigate the utility of IBT in the patients~     and settings that stand to benefit most from it. The investigators also propose a~     multi-pronged dissemination approach that will ensure that our work is readily transported~     to clinical practice and will have a direct impact on real-world treatment of opioid~     dependence. Taken together, the proposed project will produce a highly innovative~     technology-assisted pharmacotherapy protocol that can be widely disseminated to increase~     access to life-saving opioid treatment. The overarching and specific aims of this proposal~     are directly relevant to NIDA's mission of improving the accessibility, implementation and~     effectiveness of drug abuse treatment.~   "
53260|NCT02359994|"~     This is a prospective, multicenter, multidisciplinary, controlled clinical investigation~     evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis~     compared to a similar marketed hemostatic device.~      Three hundred and twenty four subjects across a maximum of 25 investigational sites~     undergoing open elective cardiac, general, or urological surgical procedures who meet the~     eligibility criteria will be intraoperatively randomized to receive no more than the entire~     contents of up to two 5 gram bellows of either the investigational device or a control~     hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm²~     and whose anatomic application site is smaller than or equal to 47cm², when bleeding is~     within the pre-defined bleeding severity range after any applicable conventional means for~     hemostasis are attempted as specified in the intraoperative procedures.~      Each investigational site is expected to enroll approximately 13-40 subjects. All~     investigational sites will be located in the U.S. Follow-up will occur at hospital discharge~     and 6 weeks post-device application. For oncologic subjects, an additional follow up will~     occur at 24 months post device application.~   "
53261|NCT02359981|"~     MyBehavior is a mobile application with a suggestion engine that learns a user's physical~     activity and dietary behavior, and provides finely-tuned personalized suggestions. To our~     knowledge, MyBehavior is the first smartphone app to provide personalized health suggestions~     automatically, going beyond commonly used one-size-fits-all prescriptive approaches, or~     tailored interventions from health-care professionals. MyBehavior uses an online multi-armed~     bandit model to automatically generate context-sensitive and personalized activity/food~     suggestions by learning the user's actual behavior. The app continually adapts its~     suggestions by exploiting the most frequent healthy behaviors, while sometimes exploring~     non-frequent behaviors, in order to maximize the user's chance of reaching a health goal~     (e.g. weight loss).~   "
53285|NCT02359669|"~     The objective of the study is to explore the impact of a combined intervention including a~     growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive~     abilities, mother-child- interaction and behavior in children of 3 to 5 years from less~     enriched home environments.~   "
53262|NCT02359968|"~     Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and~     chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy~     treatment is the FOLFOX. It is a combination of three drugs administered intravenously:~     fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.~      Another protocol of chemotherapy is widely used by certain European and American teams, due~     to promising results : a combination of two drugs administered intravenously: Paclitaxel and~     Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one~     treatment over the other.~      The objective of this Phase II study is to clarify clinical practice by comparing these two~     chemotherapy treatments.~   "
53263|NCT02359955|"~     This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture~     in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over~     to be treated with zero-degree teeth complete denture and anatomic teeth complete denture.~     For each patient, the masticatory efficiency and electromyography with different denture~     will be recorded and analysis.~   "
53264|NCT02359942|"~     1. To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric~          acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest~          and H. pylori culture).~        2. To compare the delta value of 13CO2 results between before and after ingestion of~          citric acid as test meal.~   "
53265|NCT02359929|"~     Subjects in this study have had an allogeneic (blood or marrow cells from another person)~     blood or marrow transplant to treat leukemia, lymphoma or other cancer of the blood, and~     have now developed Graft Versus Host Disease (GVHD) that is not responding to standard~     treatment. GVHD is when the graft (transplanted bone marrow or blood) attacks the~     recipient's body. GVHD occurs early after transplant (acute) and/or sometimes months after~     transplant (chronic). Both forms can be life threatening; chronic GVHD can be a lifelong~     disabling condition.~      Mesenchymal stromal cells (MSCs) exist in tissues throughout the body. One place they are~     found is in the bone marrow and from here they can be obtained by needle aspiration, the~     same way bone marrow samples are obtained to test for leukemia. This study uses autologous~     MSCs obtained from the recipient with acute and/or chronic GVHD, which have a lower chance~     of being rejected. These MSCs may promote tolerance, helping the donor immune cells accept~     the recipient's body.~      This trial is being conducted as a step toward testing the long-term hypothesis that freshly~     cultured autologous MSC grown in platelet lysate-containing medium will modulate donor~     T-cell immune responses and reduce GVHD in allo-HSCT recipients. As a phase I dose~     escalation trial of autologous MSC in patients with acute and chronic GVHD, the main aim is~     to evaluate the safety of this therapy and its effects on GVHD biomarkers and T-cell~     phenotype~   "
53266|NCT02359916|"~     The pervasiveness of high-calorie, nutrient-poor snacks in the environment is believed to~     have contributed to the epidemic levels of obesity and cardiometabolic disease in the U.S.~     This project tests whether a novel snack vending machine system that uses brief time delays~     to reduce the immediacy of reward from unhealthy snacks will improve the healthfulness of~     snack choices. If successful, this project will identify a new environmental intervention~     that could contribute substantially to obesity and cardiometabolic disease prevention~     efforts in schools, worksites, and other settings.~   "
53267|NCT02359903|"~     ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,~     Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing~     spondylitis.~   "
53268|NCT02359890|"~     This is a prospective safety assessment of the study device during radiofrequency (RF)~     ablation treatment of patients with drug refractory symptomatic atrial fibrillation~     (SMART-SF).~   "
53269|NCT02359877|"~     This is an international multicenter study of tolerability, pharmacokinetics and~     pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular~     and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec~     Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose~     administration and multiple estimated therapeutic dose administration of BCD-054.~   "
53270|NCT02359864|"~     This study is designed to assess the safety and toxicity/adverse events associated with the~     use of low dose fractionated whole brain irradiation in those patients who have been~     diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria. As a~     secondary goal it will establish whether or not the intervention with low dose whole brain~     irradiation might change the recognized progression of Alzheimer's Disease. The~     investigators will also collect information from the AMYViD ® PET Scans to determine if~     there is any correlation between neurocognitive/quality of life scores and changes in~     amyloid plaque size, number and location.~   "
53271|NCT02359851|"~     This phase II trial studies how well pembrolizumab works in treating patients with uveal~     melanoma that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor~     growth in different ways by targeting certain cells.~   "
53272|NCT02359838|"~     This research study is evaluating if co-management by a geriatrician embedded in the~     oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous~     pre-entry frailty assessment by a trained research assistant will be followed by~     randomization to geriatrician co-management versus usual care for patients found to be frail~     or pre-frail.~   "
53273|NCT02359825|"~     Current strategies for peripheral nerve repair are severely limited. Even with current~     techniques, it can take months for regenerating axons to reach denervated target tissues~     when injuries are proximally located. This inability to rapidly restore the loss of function~     after axonal injury continues to produce poor clinical outcomes. The investigators propose~     testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted~     axonal fusion technique to repair peripheral nerve injuries in humans.~   "
53286|NCT02359656|"~     The purpose of this study was to determine the clinical and radiographic long - term results~     in geriatric patients who had undergone surgical or non - operative treatment of odontoid~     non - unions, with particular regards to late bony fusion, cervical spine motion,~     neurological sequela, and patient's quality of life.~   "
53324|NCT02359162|"~     Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with~     those of the EPOCH regimen for stage IE to IIE ENKTL.~   "
53274|NCT02359812|"~     Sensorimotor impairments following stroke can lead to substantial disability involving the~     upper extremity. These impairments often involve complex pathological changes across~     multiple joints and multiple degrees-of-freedom (MJMD) of the arm and hand, thereby~     rendering them difficult to diagnose and to treat. Many potential mechanisms, such as~     weakness, motoneuronal hyperexcitability, and elevated passive impedance, can contribute to~     the impairment, thereby making it difficult to discern where best to focus treatment. The~     objectives of this study are to quantify the progression of neuromechanical properties~     throughout the upper extremity during recovery from stroke.~      The aim of this study is to examine neuromechanical properties throughout the entire upper~     extremity in stroke survivors over a period of 6 months and throughout the progression from~     the acute to the subacute to the chronic phases of recovery. The researchers hypothesize~     that excessive local and cross-coupled stiffness, heteronymous reflexes, and diminished~     individuation and proprioceptive acuity will be present among multiple DOFs in the upper~     limb. The stiffness and spasticity will increase with time post-stroke.~   "
53275|NCT02359799|"~     The purpose of this study is to investigate the effectiveness of home-based and lab-based~     stretching and active movement rehabilitation in reducing joint impairments in cerebral~     palsy using a portable rehabilitation robot. Children with spastic cerebral palsy and ankle~     impairments are divided randomly into two groups, participating in robot-guided passive and~     active movement training in a research lab setting (lab group) or in home setting (home~     group).~   "
53276|NCT02359786|"~     This is a retrospective data collection on treatment of various disorders. This registry~     will include a variety of different products, implants, technologies and procedures. The~     registry will also collect any adverse events/complications that occur during or following~     treatment of these conditions. The data may be utilized to develop strategic treatment~     pathways and/or benchmarking that will improve patient care. Ultimately, the goal of the~     registry is to enhance the understanding of healthcare and the treatment in these disease~     states.~   "
53277|NCT02359773|"~     The purpose of this pilot research study is to identify the characteristics of~     magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial~     infarction patient status. The study uses a non SQUID magnetocardiogram device.~   "
53278|NCT02359760|"~     INTRODUCTION: Dentoalveolar surgeries such as piezocision, have been developed with the aim~     to accelerate the tooth movement and therefore reduce the length of orthodontic treatment.~     Although this surgical technique seems to present several advantages, such as decreased risk~     of decalcification or orthodontic relapse, its use as a routine practice is not yet~     recommended. The main purpose of this study is to determine the duration of orthodontic~     treatment by using the piezocision. The secondary objectives are to evaluate the effect of~     this surgical technique on bone density, root resorption, osteoclast activity, inflammatory~     events and pain assessment. MATERIAL AND METHODS: The investigators will conduct a~     prospective pilot study. The experimental group will consist of 20 adults, subjects from 18~     to 40 years-old (10 women, 10 men +/- 2). The control group will consist of 40 matched~     patients, who have been already treated in the orthodontic clinic of the University of~     Montreal. Our research protocol requires a multidisciplinary collaboration. The~     reliabilities of Intra and Inter assesors will be measured for each doctor. After completion~     of the surgical guides from CBCT, the Piezocision will be performed by a piezoelectric~     insert (Piezosurgery) one week after bracket placement. To reduce bias, patients will be~     randomized to determine the surgeon and the surgical procedure will be standardized. The~     appointments will be every 2 weeks for 4 months, then every month. The investigators will~     make an assessment of pain by using a numerical visual scale, during the first 7 days after~     surgery and at the orthodontic appointment for the activation of the appliance. Analysis of~     inflammatory markers (IL-1) and osteoclast activity (RANKL, OPG) will be evaluated from the~     gingival sulcus fluid collected at day 0, day 7, day 21, second month, forth month and sixth~     month. At the end of the treatment, the overall quality evaluation of treatment using the~     American Board of Orthodontics' grading system would be realized by two blind external~     observers to limit bias.~   "
53279|NCT02359747|"~     try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also~     in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole~     Genome Amplification before PCR and sequencing of the samples to find the point mutation~   "
53280|NCT02359734|"~     To identify the key issues around use of computerized patient infusion devices (called~     smart pumps).~      To develop strategies that will improve the prevention of intravenous errors that will be~     broadly applicable.~      The investigators will conduct a national study using the general methodology developed by~     Husch et al. to allow a rapid assessment of the frequency and types of medication errors at~     an institution.~      The key questions the investigators will address are:~        1. What are the frequency and types of intravenous medication errors?~        2. How much variability is there by frequency and type among settings?~        3. After review of the initial data, what strategies appear to have the greatest potential~          for reducing intravenous medication error frequency?~        4. How effective is an intervention including a bundle of these strategies at multiple~          sites?~   "
53281|NCT02359721|"~     The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling~     and root planning at baseline, three months and six months intervals . Clinical,~     microbiological and immunological parameters were taken. Clinical parameters include~     gingival index , probing depth and clinical attachment level. In the present study, improved~     clinical and microbiological outcomes were attained using adjunctive clarithromycin,~     including GI, PD reduction, CAL gain and reductions in the frequency of detection of~     C-reactive protein, Pg, Aa. These results together with the recommended easy dosage and~     limited side effects make the use of this antibiotic in the treatment of periodontitis~     patients but only for a shorter period of time.~   "
53282|NCT02359708|"~     This study aims to investigate if recolonisation of the hand flora occur after surgical hand~     washing and is there a bacterial leakage at the glove cuff site in cardiac surgery? Also~     investigate if thera are differences in microbial flora and recolonisation between hospital~     and non-hospital persons.~   "
53283|NCT02359695|"~     The objective of this study is to assess whether a low dose of GH supplementation (0.5~     IU/day) increases clinical pregnancy rates in women with a history of POR who failed to~     become pregnant in two previous IVF cycles.~   "
53284|NCT02359682|"~     This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be~     examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam,~     The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites,~     and digitally stored the images with code numbers that did not reflect volunteers'~     information for later offline analysis by automated analysis software (AVA 3.0; Academic~     Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).~   "
53287|NCT02359643|"~     Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology~     occurring mostly in infants and children younger than 5 years of age. In developed~     countries, it is the leading cause of acquired heart disease in children. However, KD~     remains a mysterious disease.~      Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard~     treatment for KD. Aspirin have been prescribed in treatment of KD for decade even earlier~     than usage of IVIG. High dose aspirin mainly act as anti-inflammation, while low dose~     aspirin as anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage~     of KD. Hsieh et al. reported that KD without high dose aspirin had the same treatment~     response after IVIG. Therefore it is still unclear about the necessarily of high dose~     aspirin in acute stage of KD.~      This study was conduct to investigate the role of high dose aspirin in acute stage of KD via~     a multi-center randomized control trail, and we plan to achieve the followings till year~     2017:~        1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as~          group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift~          to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin~          during acute febrile stage, only use low dose aspirin (N=150).~        2. Compare data including fever days, admission duration, laboratory data (CBC/DC,~          GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation~          rate (followed at least 1 year).~   "
53288|NCT02359630|"~     Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during~     general anesthesia.~   "
53289|NCT02359617|"~     The study seeks to evaluate a novel treatment approach for performing continuous real-time~     glucose sensing and insulin delivery at the same subcutaneous tissue site.~   "
53290|NCT02359604|"~     Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it~     has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the~     pH may lead to changes in the intestinal microbiome. Small series published in adults~     suggest a predominance of streptococci, a possible reason for increased incidences of~     pneumonia under PPI therapy. Studies in children are yet scarce.~      This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance~     monitoring. All patients will have undergone conservative measures prior to initiation of~     PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks~     (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under~     PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal~     microbiome will be determined by 16S rDNA-based microbial community profiling by~     high-throughput pyrosequencing.~      Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be~     considered statistically significant.~   "
53291|NCT02359591|"~     【Background& Purpose】In order to early detect the problems a child might have during his/her~     development, an effective screening tool is of great needs. The [Taipei City Child~     Development Screening checklist] is often used to serve this process. This text version is~     mainly distributed to the parents to fill out during their child regular check-ups to the~     hospitals and clinics. The drawbacks of this checklist is that it lacks of active~     participation of the target population, and the text version limits its usage to people who~     are not familiar with Chinese characteristics, such as those new inhabitant. These lead to~     low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of~     this study was to design and develop the multi-media graphic version of the [Taipei City~     Child Development Screening checklist] based on its original text version.【Method】The~     developed muti-media system will be checked for is validity. Thirty parents/legal guardians~     of children in each target age groups will be recruited randomly for the clinical~     reliability evaluation.~   "
53292|NCT02359578|"~     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In~     analogy with the arterial systolic pressure, the lymphatic systolic pressure can give us~     information about the functioning of the cardiovascular system and fluid exchange. Actually,~     knowledge about this physiological parameter is incomplete because of the lack of~     technology. Former measurement techniques of the lymphatic systolic pressure in the living~     healthy man were invasive and too complex to be interpreted.~      The lymphatic occlusion pressure has to be clarified because lymphedema treatment,~     concerning the pressure to be applied on the edematous tissue is still based on~     controversial concepts.~      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a~     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other~     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply~     relatively high pressure to obtain a decongesting effect. These completely opposite opinions~     triggered us to study lymphatic pressure more thoroughly.~      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since~     3 years by the promoters of this study to visualize the architecture of the superficial~     lymphatic network and the progression of the lymph inside the highlighted vessels. This~     technique will be used in the present (prospective and multicentric) study to observe the~     effect of a pressure applied on the limb on the displacement of the lymph, and then to~     determine the occlusion pressure of the lymphatic vessels.~   "
53293|NCT02359565|"~     This clinical trial studies the side effects and best dose of pembrolizumab and to see how~     well it works in treating younger patients with high-grade gliomas (brain tumors that are~     generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas~     (brain stem tumors), or brain tumors with a high number of genetic mutations that have come~     back, progressed, or have not responded to previous treatment. Monoclonal antibodies, such~     as pembrolizumab, may block tumor growth in different ways by targeting certain cells.~   "
53294|NCT02359552|"~     This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of~     concept three-site study, to evaluate the effect of Rasagiline in the regional brain~     metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).~   "
53295|NCT02359539|"~     The use of autogenous graft materials has been recorded to be a gold standard in~     regenerative therapy. This study directed toward evaluation of two autogenous regenerative~     materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as~     membrane barriers for treating intrabony defects. In spite of its reported significant~     clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate~     other autogenous alternatives such as PRF that could offer predictable outcomes.~   "
53297|NCT02359513|"~     Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises~     followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an~     increasing prevalence and a serious prognosis, due to excess mortality by suicide but also~     somatic complications.~      Two types of treatments are validated : serotoninergic antidepressants (SSRI) and~     psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies~     also emphasize the important proportion of non-responders to SSRI, few of them analyze the~     reasons for this non-answer.~      To better understand the mode of action of SSRI, we should analyse the serotonergic activity~     in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor~     ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET)~     to characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF~     has the feature to be sensitive to the level of endogenous serotonin.~      A first pilot study using PET with [18F] MPPF realized between the University Hospital of~     Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F]~     MPPF in bulimic patients, suggesting a decrease in serotonin activity.~      The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate~     gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse,~     taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity~     of cortical binding of [18F] MPPF.~      In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic~     activity, it seems necessary to continues investigations, to determine if there is a link~     between brain serotonin profile and responding to SSRI in bulimia nervosa.~   "
53298|NCT02359500|"~     This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide~     ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of~     response to treatment in patients with Somatostatin receptor expressing tumors who undergo~     imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC~     as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.~     68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs~     for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either~     at staging or during follow up.~   "
53299|NCT02359487|"~     The overall purpose of this study is to evaluate an intervention that aims to reduce~     alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives~     of the study are to determine the effectiveness of an individual counseling intervention in~     reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and~     hazardous alcohol use among men.~   "
53300|NCT02359474|"~     This trial compares trabectedin alone to trabectedin in combination with regional~     hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to~     demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.~   "
53301|NCT02359461|"~     The purpose of the study is to demonstrate an improvement of vascular function, and~     particularly dependent vasodilation flow and micro-vasculature, by STENDO for diabetic~     patients compared to a control period in crossover.~      Action by shear stress causing vasodilation away from the microcirculation, STENDO should~     have a beneficial effect on vascular function in type 2 diabetics. These effects could be~     both treble just after the completion of a session with the device, and chronic with a~     potentiating effect of different sessions.~      The investigators propose to study the different vascular function evaluation parameters we~     have, to highlight these acute and chronic changes. The investigators will also study the~     physical abilities to change topics and behavioral changes (spontaneous physical activity in~     particular) and impact on subject quality of life.~   "
53302|NCT02359448|"~     This is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12~     weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up~     regularly at night > twice to pass urine. The primary objective of this study is to evaluate~     the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are~     to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night~     3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality~     of life 5) Sleep disturbance of partners 6)Safety~   "
53303|NCT02359435|"~     Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection~     with less cost than standard triple therapy. Whether reverse hybrid therapy can replace~     standard triple therapy as the recommended first-line treatment is unknown. The~     investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard~     triple therapy in first-line treatment.~   "
53304|NCT02359422|"~     The purpose of this study is to conduct a randomized controlled trial of a media literacy~     education program for middle school students with the goal of enhancing decision-making~     skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy~     relationships.~   "
53305|NCT02359409|"~     This study aims to look if use of goggle balloon can help to complete colonoscopy in~     patients with very redundant colons.~   "
53306|NCT02359396|"~     This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to~     investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and~     pharmacokinetics profile.~   "
53307|NCT02359383|"~     Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and~     reduces the formation of fibrous adhesions in patients with pleural infection, allowing a~     faster clinical, functional and radiological improve. The aim of the study is to determine~     if the CP associated with conventional medical treatment (CT) improves functional sequelae~     secondary to pleural infectious.~   "
53308|NCT02359370|"~     Justification and Objectives: The hemodynamic response to stimuli of the airways is a common~     phenomenon and its control is important to decrease systemic repercussions. The objective of~     this study is to compare the effects of intravenous administration of Magnesium Sulphate~     versus Lidocaine in the hemodynamics of this reflex after laryngoscopy and tracheal~     intubation. Methods: This double blind, randomized, single center, and prospective study~     evaluated 56 patients, ASA 1 or 2, aged between 18 and 65 years, scheduled for elective~     surgeries under general anesthesia with tracheal intubation. Patients were divided into two~     groups. Group M received 30mg/kg of Magnesium Sulphate, and group L 2 mg/kg of Lidocaine~     through continuous infusion, immediately before induction of anesthesia. The values for~     blood pressure (BP), heart rate (HR) and bispectral index (BIS) were measured in both groups~     at six distinct moments related to the administration of the drugs under study.~   "
53312|NCT02359318|"~     Background: Orthodontic bracket debonding is known to cause side-effects such as enamel~     cracks or fractures. There is a lack of information on potential benefits or side-effects of~     removing brackets from infiltrated enamel, in terms of enamel damages, in vivo.~      Purpose: To assess enamel damages following debonding in demineralised teeth with or without~     prior infiltration (Icon, DMG, Hamburg, Germany), compared to those following bracket~     removal from sound enamel, in order to provide guidelines for the right time point of~     infiltration of post-orthodontic lesions (during or following orthodontic treatment).~      Design: Single-center, randomized, single blinded, split-mouth controlled clinical trial~     Subjects: 30 subjects with fixed multi-bracket (MB) appliances treated at the orthodontic~     clinic of Dr. Roberto Vogel, Temuco, Chile: It is planned to include 20 consecutive patients~     with extensive decalcifications, and 10 patients without decalcifications. Random allocation~     of demineralized dental arch quadrants to the different treatment groups (debond with or~     without prior infiltration, and sound teeth).~      Investigated tooth groups: Upper and lower canines, and upper and lower incisors.~      Methods: Bracket bonding procedure (Transbond XT 3M, Unitek) is identical for all patients~     and also for the re-attachement of brackets. Teeth allocated to the infiltration group will~     receive bracket removal, infiltration and rebonding of new brackets 4 weeks prior to final~     debonding. De-bonding procedures are identical for all patients.~      Silicone replicas are made directly following bracket removal (prior to adhesive removal).~     Replica analysis is performed using a confocal microscope (Zeiss LSM780) at the Department~     of Cell Biology, University of Concepción, Chile.~   "
53313|NCT02359305|"~     This is a retrospective chart review. The objective of the current study is to determine the~     analgesic efficacy and side effect profile of intravenous acetaminophen when administered to~     infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were~     administered intravenous acetaminophen will be compared to infants who did not receive~     intravenous acetaminophen to determine if there were any appreciable differences with regard~     to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.~   "
53314|NCT02359292|"~     The study is performed to evaluate the total systemic exposure and lung bioavailability of~     CHF 5993 pMDI combination, in healthy volunteers subjects.~   "
53315|NCT02359279|"~     The proposed test is intended to enable dentists to differentiate between cavitated and~     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).~     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays~     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low~     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,~     pain, root canals, and possible later loss of teeth.~   "
53316|NCT02359266|"~     This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive~     symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with~     normal vitamin D levels will be monitored as controls, and they will not receive any~     intervention.~   "
53317|NCT02359253|"~     The purpose of this study is to address the allocation of therapy resources between the arm~     and the hand as well as to examine the benefits of combining passive stretching with active~     movement training.~   "
53318|NCT02359240|"~     The current project was designed to examine dynamic changes in muscle wasting during sepsis.~     Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the~     role of HO-1 in it. Researchers interested in identifying factors involved in the pathology~     of muscle wasting during sepsis.~   "
53319|NCT02359227|"~     Planned enrollment is approximately twelve subjects with stable chronic heart failure.~     Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose~     increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug~     Delivery System. Planned infusion rates of cenderitide will be administered to subjects~     continuously during four, 48-hour infusion periods.~   "
53320|NCT02359214|"~     Supplementation studies with vitamin D have been performed where cardiometabolic risk~     markers have been assessed but these are few, and results are inconsistent. Hence, the~     purpose of this study is to determine:~        1. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in~          overweight and obese adult participants for 8 weeks will significantly increase~          circulating concentrations of 25(OH)D or achieve optimal vitamin D status.~        2. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in~          overweight and obese participants for 8 weeks will significantly improve the~          cardiometabolic parameters measured.~        3. To evaluate the relationship between these variables and 25(OH)D concentration. We~          hypothesise that there will be a significant increase in plasma 25(OH)D following 8~          weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg);~          Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and~          obese participants for 8 weeks will significantly improve the cardio metabolic~          parameters measured, and there will be a relationship between these variables and~          25(OH)D concentrations.~   "
53321|NCT02359201|"~     The purpose of this study is to evaluate the reduction of craving after administration of~     V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.~   "
53322|NCT02359188|"~     Randomized, double-blind trial to investigate the influence of a single 4 hours episode of~     transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines,~     chemokines, neuropeptides, cerebral resting state and gastric motility in healthy~     volunteers.~   "
53323|NCT02359175|"~     Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic~     epidural analgesia is more effective than systemic opioids in terms of pain relief and~     preservation of postoperative pulmonary function, the efficacy of epidural analgesia in~     video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a~     beneficial effect might very well be present.~      On the other hand, the risks associated with placement of a thoracic epidural catheter are~     well known and if similar pain relief can be achieved without it with no or only~     insignificant alternative side effects, this would be preferable.~      The literature regarding the usefulness of epidural analgesia for reducing pain in~     Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some~     effect and two showing no difference, none of the studies being blinded randomized~     controlled trials of adequate size.~      The SEAVATS Study will try to answer this question.~   "
53325|NCT02359149|"~     Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last~     years indications for their use and consequently the number of patients needing treatment,~     have been increasing. Most patients require multiple injections. This has resulted in many~     eye departments administering thousands of injections per year, also at St Olavs University~     Hospital Trondheim. To cope with this increase in workload, it would be helpful if~     injections would be given not only by the physicians but also by the nurses. This study's~     objective is to compare efficiency, patient satisfaction and cost per patient of injections~     given by nurses and physicians.~   "
53326|NCT02359136|"~     Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce~     opioid requirements and improve the patient's mobilization after total hip arthroplasty~     (THA). However, the evidence for LIA in THA remains to be clarified.~      Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen~     reduces acute postoperative pain and opioid requirements after THA.~   "
53327|NCT02359123|"~     The main purpose in the treatment of patients with advanced cancer and cancer anorexia~     cachexia syndrome (CACS) is to prolong life and to improve quality of life (QoL) as far as~     possible. QoL in patients with CACS is directly related to loss of appetite and loss of~     weight. Cannabis pills are given in Israel to advanced cancer patients with various symptoms~     in order to improve their QoL. There is data on safety/toxicity of cannabis, and these pills~     are given under the regulations of the Israel Ministry of Health.~      The purpose of this study is to examine the influence of Cannabics capsules on improving~     loss of appetite and loss of weight.~   "
53328|NCT02359110|"~     The purpose of this study is to prospectively determine the influence of immediate~     pre-operative gabapentin administration on acute postoperative pain. The investigators~     hypothesize that immediate post-operative pain will be improved with pre-operative~     administration of gabapentin.~   "
53329|NCT02359097|"~     This clinical trial studies steady state blood volume maps using ferumoxytol~     non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma.~     MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used~     to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol~     non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor~     cells and the blood vessels in and around the tumors.~   "
53330|NCT02359084|"~     Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed~     by age two, and that early identification and intervention can improve outcomes. Low-income~     and minority children with ASD, however, are diagnosed later and experience greater delays~     in service provision than their white and more financially advantaged peers. Feasible,~     culturally appropriate interventions with broad scale-up potential are necessary to reduce~     this disparity. This project builds upon pilot studies of an adapted version of Patient~     Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient~     Navigation is a lay-delivered case management approach that focuses on overcoming logistical~     hurdles to care during a defined episode.~      This project has 2 components, both of which take place in urban, integrated care networks~     that provide healthcare to low-income children. This registration is for the clinical trial~     component of the study. The project is a multisite, randomized comparative effectiveness~     trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family~     Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD~     diagnosis is made. The basic structure of both intervention arms is a collaborative care~     system. The conventional care management arm (CCM) is consistent with the type of care~     provided within a traditional - but high quality - medical home. The FN arm provides more~     intensive, individually tailored, care coordination and theory-based family support.~   "
53331|NCT02359071|"~     The primary aim of our study was to analyze the independent factors affecting handover~     duration in Emergency Department. The secondary aim was to identify the factors affecting~     Emergency Department handover rates.~   "
53332|NCT02359058|"~     The main purpose of this study is to evaluate the safety and tolerability of ramucirumab in~     Japanese participants with advanced stomach cancer who have not received chemotherapy.~     Participants will take ramucirumab in combination with other anti-cancer drugs.~   "
53333|NCT02359045|"~     This study is a randomized, open-label, cross-over study in healthy subjects performed at a~     single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of~     the study is to compare the pharmacokinetics (PK) of three different prototype capsule~     formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg~     under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be~     used as basis for choice of formulation for further pharmaceutical development.~   "
53334|NCT02359032|"~     The purpose of this study is evaluate the safety and tolerability of single and multiple~     ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of~     ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study~     will also evaluate the pharmacodynamics of ASP6858.~   "
53335|NCT02359019|"~     This phase II trial studies how well pembrolizumab works in treating patients with extensive~     stage small cell lung cancer after completion of combination chemotherapy. Pembrolizumab may~     be effective in controlling small cell lung cancer for a longer period of time in patients~     with responsive or stable disease after completion of combination chemotherapy.~   "
53336|NCT02359006|"~     Opioids are the most commonly utilized pharmacological treatment for moderate to severe~     pain. However, their clinical value is hindered by the development of opioid-induced~     hyperalgesia (OIH). OIH manifests as heightened pain sensitivity, and is an increasingly~     challenging drawback to the efficacy of opioid treatment. Although the mechanism of action~     modulating OIH is not completely understood, previous animal studies suggest that this~     phenomenon is a result of proinflammatory responses. Thus, administering an adjunct~     anti-inflammatory agent may attenuate OIH. Minocycline is one such agent; it is a~     tetracycline derivative antibiotic that inhibits microglia activation, nitric oxide (NO)~     production, and the release of pro-inflammatory cytokines and chemokines. In fact, recent~     evidence suggests that minocycline may attenuate the neuroinflammatory effects of opioids~     while enhancing their antinociceptive effects. Therefore, the investigators will determine~     if minocycline will mitigate OIH in methadone-maintained patients.~   "
53337|NCT02358993|"~     The investigators will determine the efficacy of an innovative short regimen of methenamine~     hippurate on prevention of post-operative UTI in patients requiring short-term~     catheterization after pelvic reconstructive surgery through a single-blind, randomized~     controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of~     catheter removal. The investigators will study cost-effectiveness, antibiotic resistance~     profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.~   "
53338|NCT02358980|"~     Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal~     recovery in patients with cast nephropathy, severe renal failure and de novo multiple~     myeloma.~      This study will evaluate patients with multiple myeloma and severe renal failure treated~     with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.~   "
53339|NCT02358967|"~     Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease,~     attributed in part to increased oxidative stress, inflammation and dyslipidemia.~     Intervention with a naturally occurring dietary supplement may improve certain biomarkers of~     inflammation and oxidative stress and improve the lipid profile.~   "
53340|NCT02358954|"~     The goal is to establish the practical usefulness of vestibular stimulation for modulating~     pain perception and to describe the possible mechanisms that could underlie neural~     vestibular-somatosensory interactions.~   "
53341|NCT02358941|"~     Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset~     psychiatric disorders, with a negative and long-lasting impact on academic achievement,~     social integration and quality of life. In recent years, the efficacy of non-pharmacological~     treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training~     (CCT), has been at the centre of research. Although an increasing number of well-designed~     studies have shown that both methods may improve ADHD core symptoms according to parents'~     ratings, the underlying mechanisms are still a matter of debate. Teachers often report~     smaller improvements, if any. This has been explained by their lesser involvement in the~     training. It remains questionable, however, whether other factors may also account for this~     effect and whether methods other than placebo control may be applied in order to demonstrate~     the specificity and efficacy of NF and CCT.~      The main purpose of this project is to demonstrate and compare the efficacy of two different~     computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT,~     and to examine the impact of different treatment settings, with half of the participants~     being trained in a clinical setting and the other half at school. The investigators want to~     show that is feasible to implement NF and CCT in a school setting and that both methods,~     conducted either at school or in a clinical setting, may lead to significant improvements of~     ADHD symptoms as well as to specific and differential effects. Besides the differential~     impact of the settings on informant ratings, the investigators will evaluate the effects of~     the training methods on neuropsychological and electrophysiological outcome. Classroom~     behavior of the children before and after the training will be evaluated by trained~     observers not informed on treatment assignments and settings.~   "
53342|NCT02358928|"~     Concurrent with the rising prevalence of childhood obesity, the co-morbid condition of~     non-alcoholic fatty liver disease (NAFLD) has become the leading cause of chronic liver~     disease among children. NAFLD is characterized by accrual of excess triglycerides (TG) in~     the liver that leads to inflammation, fibrosis, and cirrhosis. One-third of the pediatric~     population has NAFLD, a disease strongly associated with insulin-resistance and~     metabolic-syndrome (Met-S). NAFLD is predicted to become the leading cause of liver~     transplantation in adults by 2030.~      Current understanding of NAFLD indicates that presence of excess TG in liver is an absolute~     requirement for disease progression. First-line therapy for NAFLD is focused on decreasing~     adiposity and improving insulin sensitivity through diet and exercise. Recent adult data~     indicate that dietary carbohydrate-restriction is more effective at reducing hepatic~     TG-content than traditional calorie-restriction. Few studies have been conducted to~     establish resolution of hepatic steatosis by any intervention. Such studies in pediatrics~     are primarily limited by a need for liver biopsy. However, hepatic proton magnetic resonance~     spectroscopy (H-MRS) is a new innovative tool used to quantitatively measure hepatic TG~     content in a non-invasive manner.~      The primary aim is to compare the impact of dietary weight loss via carbohydrate-restriction~     and calorie-restriction on hepatic TG-content quantified by H-MRS in obese children with~     biopsy-proven NAFLD and Met-S.~      This IRB approved protocol is a randomized control study. The investigators will recruit~     subjects from the Center for Obesity and its Consequences in Health and the pediatric~     gastroenterology clinics between the ages of 11-17 years who meet criteria for NAFLD and~     Met-S. A H-MRS will be obtained in each subject prior to the start of dietary intervention.~     Fifty-four subjects will be randomized to either a carbohydrate-restricted or~     calorie-restricted diet for 6 months with no change in baseline activity. A repeat H-MRS~     will be compared to baseline to determine the whether dietary carbohydrate-restriction is~     superior to calorie-restriction for reducing hepatic TG content. The investigators believe~     that subjects on the carbohydrate-restricted diet will have marked decrease in hepatic TG~     content compared to those in the calorie-restricted diet given the same degree of reduction~     in body mass index.~   "
53343|NCT02358915|"~     The current study intends to test the effectiveness of a two-step training paradigm for a~     set of skeletal muscles, which are above and behind the external portion of the ear~     (Peri-auricular muscles).~   "
53344|NCT02358902|"~     This study consists of a randomized, double-blind, clinical trial with two months' duration~     of follow-up. The variable used was the VAS for pain, considering the values of any~     difference between the data before and after stimulation.~   "
53345|NCT02358889|"~     The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic~     effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in~     combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating~     patients with choroidal neovascularization (CNV) secondary to age-related macular~     degeneration (AMD).~   "
53346|NCT02358876|"~     Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the~     clinic and the home, evaluate test-retest reliability of motion sensor algorithms for~     measuring bradykinesia compared to clinician raters, determine if participant-perceived~     symptom severities correlate with motion sensor measures, determine if speed, amplitude, and~     rhythm fluctuate differentially throughout the day in individuals with implanted deep brain~     stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia~     One compliance in the home.~   "
53347|NCT02358863|"~     The purpose of this study is to determine whether molecular profile-directed therapy~     (otherwise known as personalized treatment) can improve the effectiveness of standard~     chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of~     tests will be performed on a sample of tumor; based on the results of these tests, a patient~     will be assigned to a chemotherapy treatment.~   "
53392|NCT02358278|"~     The goal of this study is to determine the incidence and characteristics of Emergence~     Delirium (ED) in children aged 0 - 13 undergoing general anesthesia and being taken care of~     at the paediatric PACU of the Charité Campus Virchow-Clinic. Therefore the Paediatric~     Anesthesia Emergence Delirium Scale (PAED) is used. In order to measure the patient's pain~     level, age-appropriate pain scales (CHIPPS or FPS-R) are applied. Risk factors for the~     occurrence of ED are to be determined and therapeutic approaches in case of an occurring ED~     are to be evaluated. Finally the future implementation of ED-monitoring in the PACU is to be~     prepared.~   "
53393|NCT02358265|"~     To compare CSU disease activity at the end of the follow up phase between patients that had~     been treated daily continuously vs. on-demand in the treatment phase~   "
53348|NCT02358850|"~     This is a randomized prospective study to determine the optimal postoperative pain~     medication regimen for adults (18 years old and older) undergoing tonsillectomy with or~     without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea.~     All participants will undergo the same tonsillectomy surgical technique (with or without~     adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain~     control regimens (all of which are commonly used pain medications for post-tonsillectomy~     pain):~        1. Norco (Hydrocodone and Acetaminophen)~        2. Percocet (Oxycodone and Acetaminophen)~        3. Dilaudid and Tylenol (Acetaminophen)~      Participants will be discharged home the day of surgery and will be sent home with~     questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and~     amount of pain medications taken for the 14 days following their surgery. Data will be~     collected and analyzed to determine if there is a difference in pain levels or oral intake~     or nausea/vomiting in the different pain regimen groups. Secondary endpoints will include~     weight change from preoperative weight to weight at 2-3 weeks after surgery in addition to~     postoperative complications including visits to the Emergency Department and~     post-tonsillectomy bleed rates.~      Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and~     Throat) clinic per normal postoperative protocol and will not require any specific clinic~     visits related to this study.~   "
53349|NCT02358837|"~     With the proposed project we seek to advance the detection and diagnosis of breast cancer in~     an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim~     of this study will be to explore whether there is an advantage of ductosonography over~     conventional breast sonography in detecting and localizing breast lesions by comparing the~     diagnostic accuracy of ductosonography and conventional breast sonography in detecting~     suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of~     ductosonographic examination will be investigated. The second specific aim is to investigate~     the potential of tissue elasticity as a diagnostic marker in solid breast lesions~     (US-BI-RADS 3, 4 and 5) by elastosonography. The study design allows investigating the~     reproducibility of the method.~   "
53350|NCT02358824|"~     A randomized, open-label, single-dose, four-period, two-way, crossover study,~   "
53351|NCT02358811|"~     Sleep apnea is a common disease in the general population and more particularly in elderly~     subjects in whom prevalence can reach 30 % after 70 years old. In adults (<55 years old)~     cardiovascular consequences are well known and make sleep apnea treatment necessary. However~     elderly (>70 years old) apneic subjects are less symptomatic in terms of sleepiness, they~     usually present a lower index of respiratory events and cardiovascular consequences in this~     population are still discussed, driving some authors to consider sleep apnea in the elderly~     as a specific disease and making the need for a treatment questionable.~      In this study the investigators will focus on the comparison between adult and elderly~     apneic subjects in terms of cognitive and cardiovascular consequences. Adult apneic patients~     suffer from a decrease of cognitive performance as well as grey matter local atrophy,~     particularly in the hippocampus and in the frontal lobes. According to fewer studies, white~     matter can also be affected by a demyelinisation process. These structural modifications are~     sometimes associated with disorders of executive and memory functions. In the elderly, no~     clear association can be drawn between cognitive decline and sleep apnea. Moreover, to our~     knowledge, the cerebral state of elderly symptomatic apneic subjects has mostly not be~     investigated.~   "
53352|NCT02358798|"~     The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat~     children from birth. New treatments used for young children involve to assess efficacy~     criteria specific to this population. Standard respiratory function criteria for older~     children and adults is forced expiratory volume/second.~      This technique is not suited for preschool aged children (3 to 6 years old) because they are~     too old to be sedated and too young and immature to be able to make forced expiration~     technique that are correct, reproducible and prolonged during more than 1 second.~      For preschool aged children, in order to assess distal damage and her consequence, the~     evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic~     measure of specific resistance (sRaw), functional residual capacity by Helium dilution~     technique (CRF He), arterial blood gas measurement, pulmonary clearance index.~      All these methods have a better success rate and can be used in alternative or with forced~     spirometry. However, each of them gives only a part of information on airway and lung damage~     of detected children. It is necessary to combine them for a better information on overall~     respiratory damage.~      In France, each respiratory function test laboratory uses one or any of these methods in~     addition to flow-volume curve, in function of his practices and his equipment.~      So, respiratory function test of preschool aged children is going to diversify more and more~     to the detriment of an homogeneity of practices between different centers.~      A referent population during a longitudinal multicenter monitoring on large cohorts that~     describe the evolution of pulmonary function, obtained by a standardized methodology is~     necessary to assess the efficacy of any new treatment. And, with the homogenization of care~     of children detected of cystic fibrosis in different centers, the description of natural~     evolution of pulmonary function by a standardized methodology will improve the~     discriminative power of measure of respiratory function to assess the presence of a~     worsening in preschool-aged children.~   "
53353|NCT02358785|"~     This study will provide clinical data in an observational setting. Individuals undergoing~     LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed~     according to institutional standard-of-care (SOC) using the study stapler. All study~     subjects will be followed for approximately 4 weeks for safety and outcomes.~   "
53354|NCT02358772|"~     This is a comparison of clinical outcomes between a pre-hospital and an in-hospital~     thrombolysis patient registry.~   "
53355|NCT02358759|"~     In this newly developed protocol, and idea, is to manage those abnormally developed zygotes~     from different ART procedures.~      The investigators developed the plan and requirements needed to select the target extra~     nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing~     healthy normal embryo.~   "
53394|NCT02358252|"~     This research investigated the heart rate variability (HRV) and stroke patients' orthostatic~     hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting~     angle controlled by tilting table.~   "
53395|NCT02358239|"~     Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department~     (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular~     suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied~     with unavoidable side-effects. To the best of the investigators knowledge, no papers~     surveyed assess the feasibility of applying acupuncture as an emergent intervention means to~     the treatment of dizziness and vertigo. The investigators study targeted on filling in this~     gap by performing a clinical control trial to evaluate the efficacy and safety of~     traditional Chinese medicine - acupuncture - in treating patients with dizziness and vertigo~     in ED.~   "
56177|NCT02321800|"~     To determine the efficacy and safety of intravenous S-649266 in hospitalized adults with~     complicated urinary tract infections caused by Gram-negative pathogens.~   "
53356|NCT02358746|"~     Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is~     performed primarily by early referral; while at the same time we still struggle with the~     limited longterm ablation success of endocardial VT ablation. An underestimated number of~     VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict~     who is in need of epicardial ablation. The investigators hypothesise endo/epicardial~     substrate homogenization in a first approach to be superior to endocardial substrate~     homogenization alone, in terms of recurrence on follow-up.~      Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise~     approach in the ablation of ventricular tachycardia in a population with ischemic~     cardiomyopathy on VT recurrence.~      Study design: Multicenter prospective open randomized controlled trial. Study population:~     All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular~     tachycardia ablation.~      Intervention: One group undergoes endo/epicardial ablation and the other group has~     endocardial ablation only as a first approach.~      Main study parameters/endpoints: The main study endpoint is the difference in recurrences of~     ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator~     (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure~     success and safety.~   "
53357|NCT02358733|"~     This is a pilot study which aims to determine the role of IMSI in poor responders.~   "
53358|NCT02358720|"~     This study is a prospective, randomized, monocentre, controlled explorative study in the~     parallel-group design to determine the pain relief after RT of patients with spinal bone~     metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x~     24 Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the~     patients will undergo a staging of the vertebral column in connection with their~     radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After~     the baseline results have been recorded, the patients will be randomized into one of the two~     groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The~     target parameters will be measured and recorded at baseline, at the end of RT (t1) and~     twelve weeks (t2) and six months following the end of the irradiation period (t3).~   "
53359|NCT02358707|"~     The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen~     phonophoresis will be analyzed.~   "
53360|NCT02358694|"~     This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate~     (SBI) is safe and well tolerated in pediatric patients with IBS-D.~      Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant~     adverse events at 4 and 8 weeks and their quality of life will be better than the patients~     who receive placebo.~   "
53361|NCT02358681|"~     Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in~     the pediatric population; however, it is typically administered by the intravenous (IV) or~     intramuscular (IM) routes, both of which require a painful and distressing needle stick to~     administer.~      The intranasal (IN) route is a painless and effective way of administering analgesics,~     including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for~     painful conditions, including acute migraine headaches. However, IN ketorolac has been~     understudied in children, and it is not known how effective it is compared to IV ketorolac,~     which is currently the most common way of administering ketorolac to children. If IN~     ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable~     and painless alternative to effectively treat acute migraine headaches in children.~      Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV~     ketorolac for reducing pain in children with acute migraine headaches.~   "
53362|NCT02358668|"~     This is a single-centre, 16-week, randomized, double-blind, placebo-controlled, 3-treatment~     arm pilot study to evaluate the efficacy and safety of BTI320 in the treatment of high risk~     subjects with pre-diabetes.~      This is a pilot study aiming to test whether taking a medicine named BTI320 that slows down~     carbohydrate absorption in the gut, will lower blood sugar. The study aims to recruit 60~     individuals in Hong Kong. To take part in the study, subjects must have pre-diabetes, that~     is, they have blood sugar levels that are above normal but not reaching diabetes range. The~     medicine BTI320 is currently licensed as a health supplement in Hong Kong and is known~     alternatively as SUGARDOWN®. The investigators are comparing the effectiveness of BTI320~     against a dummy tablet. Both tablets look and taste identical and during the study, subjects~     will not know which of these tablets they are taking. There is a 4 in 5 chance of receiving~     active medication and 1 in 5 chance of receiving placebo. Subjects will be followed up~     closely every 2 to 4 weeks for a period of time up to 22 weeks.~      The study visits will take between 30 minutes to 3 hours, depending on additional checks~     that are required on a particular visit including oral glucose tolerance test and meal~     tolerance test. At visits involving meal tolerance test, subjects will be required to stay~     for approximately 3 hours. In addition, at Visit 2, Visit 4 and 3 days before Visit 7, a~     continuous glucose monitoring system device will be installed.~      Throughout the study period, subjects will return to the study center for check-ups~     including careful enquiry about whether they have developed any side-effects from taking the~     medication, physical examination, as well as blood tests.~   "
53363|NCT02358655|"~     Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by~     six times. There are several medications (blood thinners) that can prevent strokes in AF~     patients. Many AF patients present to the emergency department, but about half of AF~     patients leave without prescription of a blood thinner. The study aims to evaluate if adding~     options like giving a patient education kit, encouraging emergency room physicians to~     prescribe a blood thinner and providing a specialized AF clinic to patients will increase~     the number patients receiving blood thinners to prevent strokes.~   "
53396|NCT02358226|"~     The purpose of this study is to test the efficacy of randomizing all young men in a~     neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a~     control condition, as a means to engage young men in HIV prevention. The investigators~     hypothesize that the intervention will reduce young men's substance use and increase HIV~     testing.~   "
53397|NCT02358213|"~     This aim of this study is to compare the reproducibility of reading of five international~     experts concerning the anomalies of the salivary glands.~      The reproducibility is measure on patients and not on recorded data.~   "
56186|NCT02321683|"~     The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on~     cement-less femoral stems.~   "
53364|NCT02358642|"~     Background: Older people with neurological dysphagia are at risk of recurrent aspiration~     pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve~     swallowing and cough reflexes which may protect dysphagic patients from aspiration~     pneumonia.~      Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube~     fed because of dysphagia from cerebrovascular diseases.~      Design: Randomized placebo controlled trial~      Method: 302 older patients who have been tube fed for more than two weeks because of~     dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5~     mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical~     wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech~     therapy clinics, who have had hospital stay in previous three months. The subjects are~     followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as~     determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are~     mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by~     the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of~     public health care and personal health care costs will be performed. Intention to treat and~     log rank will be used to analyzed the group differences in outcomes. 60 subjects (30 in each~     trial group) recruited from medical inpatients at Prince of Wales Hospital will undergo~     swallowing videofluoscopy at baseline and week 12 follow-up.~   "
53365|NCT02358629|"~     Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect~     to providing additional guidewire support that is expected to allow easier crossing of~     femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will~     be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires~     revascularization.~   "
53366|NCT02358616|"~     This study is primarily exploratory and is designed to both identify factors that may have~     affected participant adherence to study product in VOICE, and describe how sexual behaviors,~     such as anal sex, may have had an effect on product efficacy. As such there is no specific~     hypothesis that is being tested.~   "
53367|NCT02358603|"~     This study is to collect human activity and ECG data from heart failure (HF) patients to aid~     in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose~     CI in patients with HF.~   "
53368|NCT02358590|"~     This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D~     adherence in older adult with osteoporosis. Half of participants will watch the videos while~     the other half will receive usual care (treating physician advice).~   "
53369|NCT02358577|"~     To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the~     efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual~     care physiotherapy, on functional recovery in critically ill children.~   "
53370|NCT02358564|"~     To better understand the relationship between gut barrier function and the symptomatology~     and pathophysiology of IBS.~   "
53371|NCT02358551|"~     The intrathoracic subclavian venous technique for pacemaker implantation may be associated~     with serious complications. Axillary vein puncture tends to reduce lead implantation~     complications such as pneumothorax and lead crush, but clinical adoption is not widely~     acknowledged, especially in China, although this approach has been proposed for 20 years.~     The major concern is the learning curve for axillary vein puncture and its success rate. The~     investigators try to prove that the success rate of axillary vein puncture is non-inferior~     to subclavian vein puncture, hence to promote the clinical application of axillary vein~     puncture to reduce pacemaker implantation complications.~   "
53372|NCT02358538|"~     To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled~     seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an~     open-label proof-of-concept study.~   "
53373|NCT02358525|"~     The aim of this descriptive study is to examine potential changes regarding inflammatory~     cytokine levels, depressive symptoms and quality of life over the course of the 4-week~     inpatient rehabilitation program which includes a cassette of modalities including~     counseling, psychosocial education and supervised exercise training as a main pillar, and to~     further investigate if there are correlations between changes in immune regulation,~     depressive symptoms and quality of life.~   "
53374|NCT02358512|"~     The purpose of this study is to determine whether intermittent nasogastric enteral feeding,~     rather than conventional continuous enteral feeding, will preserve muscle mass in the~     critically ill (Primary end-point). Such maintenance may translate into improved outcomes~     including reduced length of intensive care unit (ICU) and/or hospital stay, as well as~     number of days on a ventilator. In addition, long-term improvements in health-related~     quality of life and physical activity levels may result in these ICU survivors once they are~     back in the community. Indeed, such benefits could translate into reductions in primary~     healthcare usage and its related costs (secondary end-points).~   "
53375|NCT02358499|"~     The main goal of this study is to see how the body breaks down an antifungal drug named~     posaconazole in children with certain cancers, blood disorders, or transplantation of bone~     marrow or similar blood cells. This study will also help us learn whether a child's age,~     genetics, or disease affect how well the body breaks down posaconazole.~   "
53376|NCT02358486|"~     The aim of the study is to investigate the effect of acupuncture on functional dyspepsia~     compared with sham control. The study aims to clarify the mechanism of acupuncture by~     assessing functional magnetic resonance imaging and metabolomics.~   "
53377|NCT02358473|"~     The purpose of this study is to evaluate the safety of mogamulizumab in combination with~     docetaxel in adult subjects with previously treated locally advanced or metastatic non-small~     cell lung cancer.~   "
53378|NCT02358460|"~     A randomised controlled trial comparing volume-targeted ventilation to pressure-limited~     ventilation in infants born at or near term.~   "
53379|NCT02358447|"~     By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we~     want to show wich method has the better outcome.~   "
53398|NCT02358200|"~     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the~     safety of the combination of BMN 673 and carboplatin, and subsequently BMN 673 in~     combination with paclitaxel and carboplatin to determine the recommended Phase II dose of~     the combination.~   "
53380|NCT02358434|"~     The proposed study is a retrospective, observational study. A group of 5 subjects with the~     AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed~     during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair~     and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed~     tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and~     ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate,~     bring to market and advance the implant. Furthermore the information will be integrated in a~     model, which will be developed at the Center for Orthopaedic Engineering, University of~     Denver. By means of this model, different conditions such as the use of an advanced~     prosthesis design can be simulated and tested.~      The objective of this study is in a first step to demonstrate the capability of data~     collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing~     up from a chair and stair descent on a limited sample size of five subjects. Secondly to~     quantify and describe the three-dimensional kinematics for the cruciate retaining (CR),~     fixed bearing AttuneTM TKA during daily activities such as those mentioned.~   "
53381|NCT02358421|"~     Polycystic ovarian syndrome (PCOS) patients have an increased risk of ovarian~     hyperstimulation syndrome (OHSS) after assisted reproduction techniques (ART). In addition,~     these women have a high risk of develop further metabolic disorders. Rotterdam criteria~     defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for~     the diagnosis of PCOS.~      The aim of this study is both to determine the prevalence of PCOS in infertile patients who~     require ART in our Center and to evaluate the usefulness of each specific diagnosis~     criterium within Rotterdam criteria of PCOS as predictor of risk of OHSS. It also seeks to~     establish a cohort of patients identified according to specific Rotterdam criteria of PCOS~     to assess the incidence of long term complications.~   "
53382|NCT02358408|"~     The study consists of 2 parts:~      The objective of part 1 of this study is the performance of a short evaluation of system~     accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to~     be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure~     that the Karajishi meters are fully functioning, assure and document the accuracy of the~     comparison method, evaluate and validate the processes and procedures of the study~     methodology. The objective of part 2 of this study is the evaluation of system accuracy~     following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test~     procedures for blood glucose monitoring systems intended for self-monitoring of blood~     glucose by patients are stipulated.~      This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer:~     Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.~   "
53383|NCT02358395|"~     This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib.~     This study population is adult Japanese patients with advanced hepatocellular carcinoma in~     Sorafenib combination therapy.~   "
53384|NCT02358382|"~     The purpose of the study is to determine whether it is possible to manage the flow of blood~     through blood vessels using varying levels of carbon dioxide during cardiac surgery, and~     what effect this has on how well the major organs of the body work.~   "
53385|NCT02358369|"~     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to~     the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle~     glaucoma or ocular hypertension.~      This study will evaluate the safety and efficacy of two different doses of the Bimatoprost~     Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).~   "
53386|NCT02358356|"~     Two parallel phase II randomized open label trials of Lutetium-177 Octreotate~     (177Lu‐Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine~     (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of~     low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone~     in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).~   "
53387|NCT02358343|"~     Patients whose kidneys fail generally require dialysis treatments to sustain life. The~     ability of patients to make major adjustments in their lives for dialysis is hampered by~     depression that affects almost one-quarter of such individuals. There are no studies that~     have adequately tested whether treatment of depression is effective in dialysis patients and~     if there is any difference between the response to the two most commonly available forms of~     treatment, psychotherapy and anti-depressant drug therapy.~      To fill this important gap in the investigators knowledge, the investigators propose to~     undertake (1) a randomized controlled clinical trial of 400 patients to test whether an~     engagement interview will result in a higher proportion of dialysis patients accepting~     treatment for depression; and (2) a randomized controlled clinical trial of 180 patients to~     determine whether there is any difference in the likelihood of improvement of depressive~     symptoms with psychotherapy or drug therapy among dialysis patients with depression.~     Patients in these studies will be enrolled from among individuals receiving care in 50~     dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The~     research proposal has been developed with the support of patients, caregivers, and~     stakeholders to ensure that the findings from the study are relevant to them and can be~     readily implemented in day-to-day clinical practice. Hence, the engagement interview and~     psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and~     the dose of the study drug will be changed in partnership with the study participants. In~     addition to depressive symptoms, the effect of treatment on other meaningful outcomes such~     as fatigue and sleep will be determined.~      The two forms of treatment for depression being tested in this clinical trial are very~     different from each other and patients differ with regards to the treatment option~     preferable and/or available to them. Successful completion of the clinical trial will~     provide patients, caregivers, and other stakeholders with the information that they would~     need when faced with a diagnosis of depression in patients undergoing hemodialysis. This~     will allow patients to select evidence-based treatments to improve outcomes that are~     relevant to them.~   "
53388|NCT02358330|"~     Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound~     health and economic costs, smoking treatment is infrequently provided in healthcare~     settings, and when provided, it is not sufficiently effective. To address this, this project~     will develop and evaluate more efficient electronic health record (EHR) methods to identify~     smokers and engage them in evidence-based treatment.~   "
53389|NCT02358317|"~     The purpose of this pilot study is to determine whether a video-game based motor training~     can affect postural stability, daily living skills, autism symptoms, and white matter~     microstructure of the corticospinal tract in adolescents with Autism Spectrum Disorder~     (ASD).~   "
53390|NCT02358304|"~     The main objective of this randomised clinical trial is to is to compare the frequency of~     recurrence between patients who received nasal spray calcitonin after curettage of Central~     Giant Cell Granuloma and without it.~   "
53391|NCT02358291|"~     In our study, a multicenter randomized controlled，single blind trial will be performed to~     evaluate the effectiveness and safety of these three procedures for the treatment of~     symptomatic lumbar disc herniation.~   "
53400|NCT02358174|"~     An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been~     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.~     Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP~     activity. The aim of this work was to study the relationship between the levels of MMPs and~     NGAL and different stages hemorrhoids.~      The study provides potentially important insights to the understanding of the natural~     history of Hemorrhoids and MMPs and NGAL regulation.~   "
53401|NCT02358161|"~     The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is~     less than 5 %. Since the introduction of gemcitabine, further advances in therapy in the~     advanced/metastatic setting have been extremely slow. Numerous phase III studies have~     evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any~     observed benefits have been small and restricted to patients with a good performance status~     (PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine +~     nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine~     alone. Nab-paclitaxel is especially interesting because it is able to break-down the tumor~     matrix and increases the concentration of cytotoxic drugs in the tumor.~      Our study will explore the modification of the desmoplastic reaction seen in pancreatic~     cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog~     inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.~   "
53402|NCT02358148|"~     This prospective observational study will evaluate and compare the sensitivity and~     specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the~     presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during~     coronary angiography in the cardiac catheterization suite. In addition, we plan to determine~     if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from~     two or all three scores yields a new tool that exceeds the predictive performance of all~     three current models for determining the absence or presence of OCAD.~   "
53403|NCT02358135|"~     The investigators propose to evaluate whether an innovative collaborative connected health~     (CCH) model increases access to specialists and improves patient outcomes. CCH offers~     multiple modalities for patients and primary care providers (PCPs) to access dermatologists~     online directly and asynchronously to maximize effectiveness in a real-world setting. CCH~     also fosters team care and patient engagement through active sharing of management plans and~     multidirectional, informed communication among patients, PCPs, and dermatologists. The~     specific aims of the proposal are to (1) determine whether the CCH model results in~     equivalent improvements in psoriasis disease severity compared to in-person care, (2)~     determine whether the CCH model results in equivalent improvements in quality of life and~     mental health compared to in-person care, and (3) assess whether the CCH model provides~     better access to care than in-person care.~   "
53404|NCT02358122|"~     A dietary intervention study designed as a randomized, controlled, parallel intervention of~     6-weeks duration. A total of 75 participants will be included in the study and randomly~     allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye).~     Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood~     sampling, dietary assessment and a meal challenge will be done before (week 0) and after~     (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in~     concerning satisfaction with diet and gastrointestinal symptoms.~   "
53405|NCT02358109|"~     Spain is the second country in the world that consume more drugs. The average drug~     expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases~     during the perimenopausal period. According to the Study of the Economic Impact of Sport on~     Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro~     invested in sports promotion 50 euros are saved in health spending accumulated over 15~     years. The main objectives of this project are: i) To analyze the (cost-effectiveness)~     effect of an exercise program on the prescription of drugs in a sample of Andalusian women~     aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured~     objectively by accelerometry ) , functional capacity , quality of life and clinical profile~     of this population. iii ) To analyze the relationship between levels of physical activity /~     sedentarism and pharmaceutical expenditure. In the present project, an exercise program~     aimed at minimizing symptoms and health problems associated with the perimenopausal period~     will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of~     sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal~     women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual~     care group (n = 80). Participants in the intervention group will train 3 days / week ( 60~     min per session ) for 16 weeks.~      With the analysis of the results of this project new patterns of objective work as well as~     the most significant practical resources for the design of a master plan may be determined.~     Results are expected to be able to shed some light on the implementation of programs of~     health promotion that are both time beneficial for the Andalusian Public Health and for the~     family , institutional and community economy.~   "
53406|NCT02358096|"~     The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin~     to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic~     Kidney Disease (CKD) at 12 weeks compared to placebo.~   "
53407|NCT02358083|"~     The purpose of this study was to determine whether messages about 1. relative risk of~     vaccination vs. other activities and 2. strength of doctor's recommendation influenced~     parental intention to get own child vaccinated against human papillomavirus (HPV) or~     Influenza.~   "
53408|NCT02358070|"~     The purpose of this study is:~        -  to investigate the risk factors of HCC among Americans with focus on lifestyle factors~          and energy balance.~        -  to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated~          with HCC risk through a genome-wide search.~        -  to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle~          factors, and to explore if there are interplays or effect modifications between genetic~          factors and viral infection or lifestyle factors.~   "
53409|NCT02358057|"~     The main objective is to determine if dexmedetomidine combine with alfentanil allow a level~     of conscious sedation within maximum security conditions in an emergency department.~      Patients included in the study will receive an injection of dexmedetomidine via a TIVA~     Injectomat Agilia, specially programmed for the injection of dexmedetomidine.~      Patients will also receive a dose of alfentanil, 1 minute before the technical act.~   "
53460|NCT02357355|"~     Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body.~     The disease can result in difficulties with strength and balance as well as in foot~     deformities such as high arches, hammer toes, and tight ankles. Because of these~     difficulties, the disease may affect driving, especially because driving requires quick~     responses at times such as slamming on the brakes or turning the steering wheel quickly. The~     following study determines driving performance in individuals who have CMT 1A.~   "
53410|NCT02358044|"~     This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with~     sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in~     treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus~     (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy~     (assessed by the percentage of participants achieving sustained virologic response 12 weeks~     after ending study treatment [SVR12]) and safety between the grazoprevir plus elbasvir~     treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the~     percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is~     non-inferior to that in the SOF plus PR treatment arm.~   "
53411|NCT02358031|"~     Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck~     (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a~     platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a~     platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that~     pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free~     survival and overall survival compared to standard treatment.~   "
53412|NCT02358018|"~     The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan,~     instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor.~     68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the~     USA, with better tumor detection than with OctreoScan.~   "
53413|NCT02358005|"~     Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with~     extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical~     stimulation in the management of post-stroke spasticity of the upper limb. However, it was~     not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on~     the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the~     optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity~   "
53414|NCT02357992|"~     The goal of this clinical research study is to evaluate the outcome of a standard radiation~     treatment called stereotactic radiotherapy (SRT) for NSCLC.~      Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years~     after the procedure. The safety of the study treatment will also be analyzed.~   "
53415|NCT02357979|"~     The objective of this clinical study is to evaluate whether the use of the new CO2 - 9.3μm~     short-pulsed laser increases the caries resistance of occlusal pit and fissure surfaces in~     patients in addition to fluoride therapy. This will be quantified by visual exams with the~     International Caries Detection and Assessment System (ICDAS II), SOPROLIFE daylight and blue~     fluorescence, and DIAGNOdent Laser Light-induced Fluorescence. This is a randomized, single~     blind, prospective, split mouth controlled, clinical trial over 12 months.~   "
53416|NCT02357966|"~     This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3,~     in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of~     efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo~     plus antibiotics in approximately a 3 to 1 ratio.~   "
53417|NCT02357953|"~     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the~     surgery and the patient. The investigators currently use a local hemodynamic protocol based~     on the data of the literature. According to this protocol, specific patients may require~     cardiac index and central venous oxygen saturation monitoring. the investigators chose to~     monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD)~     (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection~     of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The~     variation of temperature is measured with an arterial femoral catheter and allows the~     assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed~     the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio~     thorac vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002,~     Godie O Ann Thorac Surg 1999).~      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral~     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the~     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be~     more difficult because of the port. It may be interesting to use the port for TPTD in order~     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by~     the port was as reliable as the classical measurement with a CVC.~      The aim of this study was to assess whether measurement of the CI by TPTD was possible and~     reliable via the port. The investigators conducted a prospective study comparing the~     measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.~   "
53418|NCT02357940|"~     The purpose of this 14-day, two phase clinical study is to test the tolerance of a new~     over-the-counter moisturizing balm on subjects with eczema.~   "
53419|NCT02357927|"~     This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in~     breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services~     (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by~     the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4~     item measure and the EORTC Intervention overall satisfaction scale.~   "
53420|NCT02357914|"~     Shoulder pain is very common in people with spinal cord injury (SCI). Persons with~     high-level paraplegia have higher chances to suffer shoulder pain and injury than those with~     lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the~     shoulder during routine daily activities, the onset of pain or injury lead to increased~     healthcare expenses, limitation in activity, depression, decreased participation, and~     reduced quality of life. One of the main reasons of shoulder pain is believed to have a~     altered scapular movement. To clarify the mechanism of the shoulder pain and injury,~     comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound~     is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder~     pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound~     with motion capture system to evaluate scapular movement was developed and presented~     favorable results in able-bodied population. The purpose of this study is to compare the FUS~     and widely used skin-based method against a radiographic based gold standard in people with~     paraplegia, and to elucidate the relationship among scapular movement and shoulder pain,~     pathology. This study will also allow us to gain more understanding of how level of injury~     influences the scapular behavior during functional activities. The investigators believe~     more severe shoulder pain and pathology will be associated with greater abnormal scapular~     movement. The investigators also believe that people with high-level paraplegia will have~     greater scapular abnormality than people with low-level paraplegia during arm elevation and~     weight relief raise tasks. By completing this study, the investigators will expect to~     deliver a reliable and valid tool to evaluate scapular movement and gain a better~     understanding how the altered scapular movement is related to shoulder pain and pathology.~     The investigators will also learn how the level of injury affects the scapular behavior~     during functional activities. The results of this study may help the shoulder pain~     management leading to the improvement in the quality of life of individuals with SCI.~   "
53426|NCT02357823|"~     Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive~     subjects, representing the leading etiological agent of severe bacterial pneumonia.~     International guidelines recommend that HIV positive patients aged >=19 years, who are~     13-valent conjugate vaccine (PCV13) naïve, should receive a single dose of PCV13.~     Pneumococcal polysaccharide vaccine 23-valent (PPV23) should be given >=8 weeks after~     indicated dose of PCV13, and a second dose of PPV23 should be given 5 years later. For those~     who previously received PPV23, PCV13 should be administered >=1 year after the last PPV23~     dose. HIV infection affects humoral immunity both through reduced T-cell help and changes in~     the B-cell compartment. Neither amount of circulating memory B cells nor their functions are~     restored by antiretroviral therapy: this may affect antibody mediated immunity, even in~     well-treated HIV patients. In asplenic childrens a single dose of PCV13 seems sufficient to~     restore the pool of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has~     been reported that a single dose of 7-valent pneumococcal conjugate vaccine induces~     significant increases in serotype-specific memory B-cell populations, conversely,~     immunization with PPV23 seems to decrease memory B-cell frequency. However, data on~     immunological response after PCV13 in HIV positive adults are still scanty and the optimal~     pneumococcal prophylaxis strategy needs further investigation. Number of PCV13 doses is~     actually demanded to clinical judgment for each patient; also current Italian indications~     recommend at least one dose, but till 3 doses seem to be suggested for immunocompromised~     patients. Present study aims to investigate short and long term immunological response after~     different standard vaccine schedule and to evaluate pneumococcal nasopharyngeal colonization~     in vaccinated patients.~   "
53427|NCT02357810|"~     The purpose of this clinical research study is to learn if pazopanib when given in~     combination with topotecan can help to control sarcomas. The safety of this drug combination~     will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
53428|NCT02357797|"~     This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study~     comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88~     stable patients with a research diagnosis of schizophrenia determined with the Structured~     Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness~     duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining~     whether earlier illness moderates greater negative and /or cognitive symptom reduction in~     response to vortioxetine.~   "
53429|NCT02357784|"~     Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence~     (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction~     than those with just UI or FI. In many situations, DI is the result of a failure of~     communication between the brain and the sacral nerve, which controls the bladder, bowel, and~     pelvic floor. The only currently available treatment with level 1 effectiveness data for the~     treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation~     is a standard of care treatment that involves surgically implanting a device in to a~     patient's body to target communication issues between their brain and bladder/bowel. Because~     the exact mechanism of action of SNM remains unclear, this study aims to better understand~     how SNM affects the nerves of patients with DI. Patients who are already planning on~     undergoing SNM device implantation will be recruited to this study. Study participants will~     undergo Current Perception Threshold (CPT) Testing and fill out questionnaires before SNM~     and 3 months after their SNM treatment. CPT Testing uses mild electrical stimulation in the~     urethra and rectum to measure and quantify the amount of physical stimuli required for the~     nerves in the pelvic floor to sense a stimulus. By learning more about nerve function in~     patients with DI, the investigators hope to find a way to screen patients before treatment~     with SNM to make sure the treatment will be effective for that individual.~   "
53430|NCT02357771|"~     Advances in orthodontics have improved the quality of appliances and treatment protocols,~     raising the standard of patient care. However, enamel demineralization is still a problem~     associated with orthodontic treatment, leading to the formation of white spot lesions; this~     is a grave concern to orthodontists and patients.~      The overall prevalence of white spot lesions among orthodontic patients has been reported to~     be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create~     areas of plaque stagnation, especially around brackets, bands, wires, and other attachments.~     Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S~     mutans), are higher in orthodontic patients than in non-orthodontic patients.~      This causes demineralization around the brackets and leads to white spot lesions. They are~     most prevalent around the cervical region of bands in the posterior region, whereas in the~     anterior region, the lateral incisors in both arches, followed by the canines, are most~     commonly affected.~   "
53431|NCT02357758|"~     Approximately, 3% of males and 8% of females will develop a urinary tract infection (UTI)~     during childhood, and most of these will be effectively treated by short-term antibiotic~     therapy. A subset of these children (20-48%), will develop recurrent UTI (RUTI), which may~     have long-term effects in the form of hypertension or renal damage.~      In an effort to prevent RUTIs physicians prescribe sulfamethoxazole-trimethoprim (Septra) or~     nitrofurantoin as low dose antibiotic prophylaxis. However, recent evidence suggests that~     during prophylactic therapy the body is exposed to antibiotic levels capable of increasing~     antibiotic resistance and bacterial virulence. This has been shown to be true in the~     uropathogens E. coli and Staphylococcus saprophyticus, yet it is not known if Enterococcus~     sp. demonstrate similar mechanisms. Additionally, antibiotics have been shown to disrupt the~     natural balance of the human microbiome, potentially leading to major long term problems.~      As a uropathogen, enterococci consistently rank in the top 3 causes of RUTI, especially in~     children under 3 years of age. Additionally, Enterococcus is notorious for developing~     antibiotic resistance and studies have shown that children with enterococcal UTIs exhibit a~     higher rate of recurrence than those with non-enterococcal UTIs.~      The investigators hypothesize the current practice of antibiotic prophylaxis in children~     with RUTI is detrimental and can change the bacterial and sensitivity profiles of these~     patients.~   "
53432|NCT02357745|"~     Neopterin has been identified as a marker of cellular immune system activation. It is~     synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is~     indicative of a pro-inflammatory immune status. Neopterin concentration increases with~     increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and~     Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal~     disease as well as other systemic diseases.~   "
53433|NCT02357732|"~     This study evaluates nivolumab in combination drug treatments involving 1) nivolumab and~     dabrafenib 2) nivolumab and trametinib and 3) nivolumab, dabrafenib and trametinib in~     patients with BRAF or NRAS-mutated metastatic melanoma.~   "
80348|NCT02005731|"~     This is a prospective, pilot study for assessing the safety and efficacy of the treatments~     performed with Renova (LI-ESWT) on symptomatic ED patients.~   "
53434|NCT02357719|"~     The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in~     adults is now well documented as well as its cardiovascular repercussions. Previous studies~     showed a conclusive link between SAHS and severe cardiovascular diseases such as~     hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health~     issue in adults.~      In this context, early detection of such a disease is crucial if the management is tailored~     to the patient, the practitioner's choice of therapy moving towards continuous positive~     airway pressure (CPAP) or mandibular advancement device. The detection is based on full~     nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold~     standard but it is a time consuming and costly examination. Polygraphic recording is a test~     that allows simplified the diagnosis of severe patients, but may not be sufficient for mild~     form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The~     validation of a technique for identifying patients most at risk to either limit the number~     of polysomnographic examination is requested.~   "
53435|NCT02357706|"~     Little is understood about how different auto-adjusting PAP devices operate. The purpose of~     this evaluation is to compare two devices in a randomised two night PSG trial.~   "
53436|NCT02357693|"~     The purpose of this study is to determine whether patients at high risk for postoperative~     nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the~     perioperative period.~   "
53437|NCT02357680|"~     This study will investigate the effect of diaries written by relatives for critically ill~     patients on the risk of posttraumatic stress symptoms.~      Utilizing a randomized controlled design pairs of one patient and one relative will be~     assigned to either diary intervention or standard care. The effect of the diary will be~     evaluated using a questionnaire 3 months post charge.~      The results of this study will add to the body of knowledge on how diaries may help critical~     care survivors and their relatives to proceed with their lives.~   "
53438|NCT02357667|"~     This study will evaluate the differences in cardiovascular parameters between women with~     severe preterm preeclampsia and those without preeclampsia using echocardiography and~     maternal blood. The investigators will also look at associations of abnormal cardiovascular~     findings and immediate complications among a high risk cohort of pregnant African American~     women.~   "
53439|NCT02357654|"~     During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days~     after fertilization. For a successful pregnancy to take place, that embryo must then implant~     in the properly primed and staged endometrium, which subsequently must continue to develop~     to accommodate the growing and maturing embryo and then fetus. This process is normally~     regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has~     been found that after IVF additional support for the endometrium with progesterone improves~     implantation and subsequent live birth rates in IVF cycle . Recent data has shown that~     additional supplementation with a single administration of a GnRH agonist around the time~     the time of embryo transfer may further enhance these rates .~   "
53440|NCT02357641|"~     Examination of probable distinction between cardiac or non- cardiac thoracal disorder via~     echocardiographic myocardial strain analysis~   "
53441|NCT02357628|"~     The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT)~     will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal~     soft tissue wounds.~   "
53442|NCT02357615|"~     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)~     with nifedipine controlled-release tablets (Adalat）in the treatment of Early Morning Blood~     Pressure and Central Arterial Pressure.~   "
53443|NCT02357602|"~     Purpose:~      The purpose of this study is to characterize the dose-proportionality in the distribution of~     tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and~     TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues~     of healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.~   "
53444|NCT02357589|"~     The 3D-systems have emerged also to the world of surgery, and the three-dimensional~     laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy~     there are only two-dimensional view, which is somewhat challenging when operating in~     three-dimensional environment. Even though the 3D-systems have been widely studied in~     laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical~     point of view and no prospective randomized trials have been published. Therefore, the~     purpose of this study is to investigate is there something to gain in changing into 3D~     laparoscopic system for cholecystectomy (LCC).~   "
53445|NCT02357576|"~     Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated~     with significant morbidity and mortality in neonates and is felt to be exacerbated by~     soybean-based lipid emulsions. Much research is currently being directed at identifying ways~     to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of~     parenteral nutrition is one possible strategy. In this study we will compare standard dosing~     of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for~     the development of cholestasis and adequate growth between the two groups. Longterm followup~     will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.~      Funding source - FDA OOPD~   "
53446|NCT02357563|"~     Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia,~     abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more~     surgeries due to their particular position in the myometrium. Surgery, moreover, should~     always be tailored, particularly in patients wishing to conceive, to preserve the integrity~     of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in~     patients with submucous fibroids, but are associated with several side effects. the eighty~     percent of patients treated by UPA showed a clinically meaningful reduction of more than 25%~     in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared~     to be maintained for 6 months after the end of UPA treatment~   "
53461|NCT02357342|"~     Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety~     and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related~     Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to~     neovascular AMD despite previous Anti-VEGF treatment.~   "
80998|NCT01997229|"~     The purpose of this study is to determine if eculizumab is safe and effective for the~     treatment of refractory generalized Myasthenia Gravis.~   "
53447|NCT02357550|"~     This project tend to investigate the affection of ketone bodies on brain metabolism. This~     will be done by measuring human cerebral uptake of energy substrates, together with~     functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia~     in healthy subjects by ketone infusion.~      Hypotheses~        1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake~          by brain cells contributing to hyperglycaemia.~        2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood~          flow.~        3. Altered oxygen consumption during hyperketonemia in healthy subjects.~   "
53448|NCT02357537|"~     This study is designed to assess differences in remote and on-site patient study~     participation in the State of Massachusetts, as well as the significance of dietary~     interventions and their impact on UC. The study will activate one site with a Principal~     Investigator who will utilize each subject's local care system (local Gastroenterologist) to~     collect study data, along with telemonitoring and video visits, to make key study~     assessments and decisions regarding subjects' progression in the study.~   "
53449|NCT02357524|"~     The study will determine the magnitude and duration (time to resolution i.e., returning to~     normal ranges) of elevations in the following coagulation test results after a single 1200~     mg dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated~     clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa~     Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).~   "
53450|NCT02357511|"~     The study aims to define the sensitivity and specificity of a novel continuous noninvasive~     blood pressure monitor.~   "
53451|NCT02357498|"~     The purpose of this research study is to compare the extent of resection (EOR) in patients~     with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a~     microsurgical technique to those patients who have undergone surgery with a fully endoscopic~     technique. Another goal is to compare surgical complications, endocrine outcomes, visual~     outcomes, length of surgery, length of hospital stay, and readmission rates between the two~     transsphenoidal surgery techniques. This is an observational data collection study with no~     experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a~     pituitary tumor is a unique procedure and there is little information comparing the two~     surgical techniques.~   "
53452|NCT02357485|"~     This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the~     stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade~     I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under~     Institutional Review Board (IRB) approved protocol.~   "
53453|NCT02357472|"~     The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for~     patients with previous poor ovarian reserve and response in an attempt to improve pregnancy~     outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the~     use,especially in Asian people. Whether the double dosage of DHEA in patients with poor~     ovarian reserve and response in China can improve the IVF outcome with little side effect is~     unknown.~      The aim of this randomized controlled study is to compare the effect of a higher dose (150mg~     daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor~     ovarian responders. The effect of DHEA action on the cumulus cells will be examined.~   "
53454|NCT02357459|"~     This study is a double-blind, randomized, single-dose study to assess the safety and~     efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.~      Approximately 450 patients with OA of the knee will be randomized to one of the three~     treatment groups (1:1:1) and treated with a single intra-articular (IA) injection of:~        -  40 mg of FX006~        -  40 mg of Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in~          protocol)~        -  Normal Saline~      Each patient will be evaluated for a total of 24 weeks following a single IA injection.~     Following screening, safety and efficacy will be evaluated at 7 out-patient visits (Days~     1[Baseline], Weeks 4, 8, 12, 16, 20, 24).~   "
53455|NCT02357433|"~     The study objective is to clarify whether the application of high doses CPFA (Coupled~     Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce~     hospital mortality in septic shock patients in intensive care unit (ICU).~   "
53456|NCT02357420|"~     The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on~     vomiting episodes, gastric emptying and gastroparesis symptoms in patients with Type 1 and~     Type 2 diabetes mellitus and gastroparesis. Study drug (RM-131 and placebo) will be~     administered subcutaneously in a blinded fashion.~   "
53457|NCT02357407|"~     Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat~     infections. Their efficacy has been shown to be linked to the ratio area under the curve~     (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the~     bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an~     AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30~     to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced~     recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar~     to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be~     related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ~     appears of potential interest, particularly in case of severe infections (intensive care~     unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected~     (OAI) patients), with an increasing level of evidence of its use.~      However, FQ TDM requires access to the full AUC of the drug with the need of many samples~     drawn to patients. This appears to be irreconcilable with clinical practice but can be~     achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating~     pharmacokinetic parameters of the drug by introducing covariates (demographic, biological,~     clinical…) and modelling inter-individual pharmacokinetic variability. The model created~     allows then accessing to individual parameters of patients and thus, estimating~     concentrations and AUC of the FQ. This approach may also be used in clinical practice to~     determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum~     of samples.~   "
53458|NCT02357381|"~     A multi-center, prospective, non-randomized, single arm, open label, post-market,~     observational study to evaluate the use of the eneura, springtms system in reduction of~     migraine headache symptoms.~   "
82090|NCT01982903|"~     The purpose of this study is to determine whether urinary connective tissue growth factor~     (uCTGF) can predict the onset of fibrosis in transplanted kidneys.~   "
53462|NCT02357329|"~     This study will investigate fat taste and if free fatty acids (FFA) in food function as a~     signal for fat content. FFA are quite unpleasant - the investigators want to measure if the~     concentration in different foods correlates with hedonic preference. FFA concentration from~     a variety of foods will be used to determine if people who have greater sensitivity for FFA~     find foods with higher FFA concentrations less acceptable. Further, this study with~     determine whether the relationship between fat taste and hedonic food preference is modified~     by sex and body mass index (BMI).~   "
53463|NCT02357316|"~     The investigators seek to determine how genetics and the environment influence the ability~     to taste and smell fat. The investigators believe that people who consume higher fat diets~     and people who have higher body fat levels are less able to taste and smell fat. The~     investigators expect to see that people who are less able to taste and smell fat will share~     certain genetic differences.~   "
53464|NCT02357303|"~     The upper endoscopy is one of the most common methods for the diagnosis and treatment of~     upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify~     early neoplastic lesions.~      Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this~     fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired~     by the presence of foam, bubbles or gastric mucus.~      To improve visualization of the gastric mucosa, it is possible to administrate an oral~     solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or~     N-Acetylcysteine previously to the procedure.~      The aim of this project is to determine if the use of premedication with simethicone, alone~     or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI~     endoscopy.~   "
53465|NCT02357290|"~     Children between the ages of 5-17 years old who have or display symptoms of emotional~     dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are~     invited to participate in a 12-week research study to determine the effectiveness and safety~     of the natural treatment N-acetylcysteine (NAC) for children with emotional and behavioral~     problems. After undergoing a comprehensive evaluation by medical doctors with a specialty in~     this area, children who are found eligible to participate in this research study will be~     treated with NAC. Following the evaluation period, this research study requires 12 weekly~     visits, either in our office or over the phone, in an effort to closely monitor each child's~     response to the medication. Eligible participants will receive study-related evaluations and~     weekly study visits with our study doctors at no cost.~   "
53466|NCT02357277|"~     There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in~     the United States. While oral GCs are recognized to have destructive skeletal effects, far~     less is known about the effects of IGCs. This gap in our knowledge is of critical~     importance, not only because of the prevalence, chronic nature and long duration of IGC use,~     but also because several studies have found that patients using IGCs are at increased risk~     of fracture. Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may~     augment negative effects of estrogen loss and aging.~      The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to~     decreased bone formation and uncoupling of bone turnover, a potential mechanism for the~     effect of IGCs on the skeleton.~      To test our hypothesis, the investigators will perform a randomized, controlled 4 week study~     of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover~     and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These~     studies are of high clinical significance because there are currently no guidelines~     regarding screening, prevention or treatment for osteoporosis in patients using IGCs, nor is~     IGC use taken into account when calculating fracture risk in PM women, the group at highest~     risk of fracture. High quality evidence for low volumetric bone mineral density (BMD) and~     abnormal bone quality in PM women using IGCs has the potential to change clinical practice~     by supporting specific interventions to prevent bone loss and fractures.~   "
53467|NCT02357264|"~     This project will study the use of ultrasound of the chest for the detection of fluid in the~     lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.~     Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which~     patients develop elevated blood pressure and may develop protein in their urine, neurologic~     abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and~     kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort~     and significant morbidity and mortality. It can be detected using chest x-ray, although this~     type of imaging offers significant disadvantages, including radiation, which is of~     particular concern in pregnant patients. In addition, previous studies have demonstrated~     that chest x-ray is not very accurate in the detection of fluid in the lungs. Multiple~     previous studies have demonstrated the utility of chest ultrasonography in detecting fluid~     in the chest, although the vast majority of these studies involved patients with acute~     decompensated heart failure. Our goal is to evaluate bedside ultrasound of the chest in~     patients with pre-eclampsia in comparison to normal pregnant patients to determine whether~     these patients have abnormal fluid in the chest.~      The investigators will divide our patients into two groups. In the study group, the~     investigators will include patients with pre-eclampsia with or without shortness of breath,~     and in the control group, the investigators will include pregnant patients without~     pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study.~     These patients will then undergo an ultrasound of the chest, performed by a member of the~     Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the~     ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by~     expert reviewers.~   "
53468|NCT02357251|"~     This is a single-blinded randomized control trial comparing the current perioperative care~     of the investigators gynecologic oncology patients with a standardized perioperative~     enhanced recovery pathway. Adult patients undergoing laparotomy by one of the gynecologic~     oncology surgeons will be eligible to participate. The primary outcome will be length of~     hospitalization including any days of readmission in the 30 days post-operatively. Secondary~     outcomes will include 30-day readmission rate, complications, quality of recovery, and pain~     control.~   "
53469|NCT02357238|"~     In order to improve the investigators knowledge about uveitis and the underlying mechanism~     of disease, the investigators propose collecting blood from patients with uveitis, isolating~     DNA and sequencing the DNA to identify genetic mutations or associations in these patients.~   "
53470|NCT02357225|"~     Pyridostigmine is an acetylcholinesterase inhibitor, which degrades acetylcholine at the~     neuromuscular junction. Based on recent studies, pyridostigmine may be an effective adjuvant~     treatment for people with Pompe disease, as it increases the functional impact of this~     neurotransmitter.~      Hypothesis: the use of pyridostigmine in Pompe disease will improve transmission of~     acetylcholine across the neuromuscular junction, skeletal muscle function, respiratory~     function, and quality of life.~   "
53471|NCT02357212|"~     The aim of this research is to evaluate the effect of early invasive therapy and appropriate~     revascularization compared with conservative management and selective revascularization~     among women with an acute coronary syndrome.~   "
53472|NCT02357199|"~     This study aims to investigate the prevalence of oral infection in chronic renal disease~     patients and to examine whether a focused oral hygiene intervention can reduce oral~     infection leading to reduced systemic inflammatory parameters in chronic renal disease~     patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation,~     and chronic renal disease patients who has been transplanted 1-1½ year previously. The~     results will be compared to a gender- and age-matched healthy control group.~   "
53473|NCT02357186|"~     Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are~     mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009,~     the Pediatric Emergency Care Applied Research Network has published a rule clinical decision~     support of mild head injury of the child with the aim to identify children at very low risk~     for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary~     exposure to radiation ionizing. This clinical decision rule constructed from a multicenter~     prospective cohort 42,412 American children allows on anamnestic and clinical elements to~     guide medical decision for conducting brain imaging, hospital monitoring or discharge home~     placing the child in three levels of risk of clinically severe intracranial lesions.~      Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild~     head trauma the child's use of the clinical decision rule provided that it is the subject of~     a validation study externally. Indeed, after the construction phase and before its daily~     application, a clinical decision rule must be subject to an broad validation process so that~     its predictive performance can be definitively established.~      The investigators' work aims to conduct this broad validation study prospective multicenter~     way in a French pediatric population, as recommended by the French Emergency Medicine~     Society, in order to confirm or deny its predictive performance and allow its application~     and generalization. The investigators will check and if the Rule Clinical Decision is~     adapted or not to the management of mild head injuries in the French pediatric population.~   "
53474|NCT02357173|"~     The purpose of this study is to examine cigarette smokers' use of electronic cigarettes~     (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.~   "
53475|NCT02357160|"~     The Value of Integrating Visual Arts (VIVA): Evaluating the Benefits of Hospital Room~     Artwork on Inpatient Wellbeing will use a large randomized controlled trial design to~     investigate how the inclusion of visual arts in the hospital rooms of cancer patients~     benefits their quality-of-life during treatment. This 18-month research study will provide~     hospitals with evidence of the therapeutic value of the visual arts as measured by patients'~     perceptions of anxiety, pain ratings, use of pain medications, need for nurses, and length~     of stay. Data also will be collected on patients' evaluation of hospital rooms, specifically~     on décor including artwork, so as to correlate patient wellbeing with the presence of~     artwork. Ultimately, this project aims to increase support of and appreciation for the arts~     from a major consumer—namely, healthcare providers—by justifying the value of integrating~     local visual art into inpatient rooms and providing patients with aesthetic choice during~     their stay.~   "
53476|NCT02357147|"~     This study was originally designed as a multicenter, double-blind, randomized,~     parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram~     (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in~     combination with pemetrexed and cisplatin in participants with unresectable Malignant~     Pleural Mesothelioma (MPM) who have not received prior systemic therapy.~      Per a business decision made by the Sponsor, participants who were randomized to amatuximab~     and are still on active treatment at the time of the protocol amendment may consent to~     continue to receive weekly treatment with amatuximab until disease progression or~     intolerable toxicity at the discretion of the principal investigator. Participants~     randomized to placebo or who were in follow-up at the time of the amendment have been~     discontinued from the study.~   "
53477|NCT02357134|"~     The goal of this clinical research study is to learn if high-flow oxygen, low-flow oxygen,~     high-flow air, or low-flow air, when given during structured exercise sessions, can help~     reduce difficulty breathing in cancer patients. Researchers also want to learn if these~     therapies can help to improve lung function and quality of life.~   "
53478|NCT02357121|"~     This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser~     interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue~     and to gather data for the design of future studies. Intra-procedure temperature and~     concurrent rectal wall thermistor monitoring will be performed for internal validation.~     Subjects will be monitored for adverse events, and health-related quality of life (HRQOL)~     questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to~     evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also~     be monitored.~   "
53479|NCT02357108|"~     The goal of this study is to learn what types of conversations patients prefer to have with~     their doctor about treatment options and how patients view their doctor's compassion.~   "
53480|NCT02357095|"~     The purpose of this study is to determine whether UACE(uterine artery chemo-embolization)~     followed by suction curettage under the guidance of ultrasonography or hysteroscopy can~     decrease complications in the treatment of Caesarean scar pregnancy (CSP).~      CSP is a special form of ectopic implantation within a fibrous tissue surrounding the~     previous delivery caesarean scar. The probability of CSP is 1:1800 to 1:2,226 in all~     pregnancies, and 6.1% in ectopic pregnancy after cesarean delivery. It's a long-term~     complication after cesarean delivery with very serious consequences,such as uterine rupture~     and massive uterine bleeding.There are more than ten methods to treat CSP,however, no~     universal management guidelines have been established up to now.~      Present methods for CSP treatment include:1)medical treatment,usually systemic or local~     methotrexate（MTX）;2）suction curettage;3)medicine combined with uterine curettage;3）surgical~     treatment（hysteroscopic,laparoscopic or vaginal surgery）;4) uterine artery~     embolization(UAE);5) The combined use of the above methods.~      Moreover, the rupture of the CSP and heavy bleeding may still occur following medical~     treatment.Suction curettage and excision of the CSP are associated with profuse bleeding.~     Surgical treatment is less micro-traumatic than nonsurgical interventions. For CSP, UAE~     followed by suction curettage appears to have more advantage than systemic MTX treatment and~     may be a priority option.So some author suggests that curettage and systemic methotrexate~     therapy and embolization as single treatments should be avoided if possible,combination of~     them is more effective. Plenty of evidences suggested that UACE followed by suction~     curettage under the guidance of ultrasonography or hysteroscopy is a priority choice.~      However,in our clinical practices,suction curettage of CSP is more difficult than usual~     induced abortion procedure of normal early pregnancy,because PCSD(previous cesarean scar~     defect)is very common in CSP.In random populations the incidence of PCSD is present in~     24%-69% of women evaluated with transvaginal sonography. Scar defects were seen in 61%~     (66/108), 81% (35/43) and 100% (11/11) of the women who had undergone one, two and at least~     three Cesarean sections by the transvaginal ultrasound examination.~      What is the incidence of complications of suction curettage combined with UACE for CSP~     treatment remains unknown.How to decrease the complications remains unknown too.So we~     designed this study.~   "
82608|NCT01976117|"~     Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from~     patients with COPD and bacterial infection~   "
53482|NCT02357069|"~     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in~     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.~   "
53483|NCT02357056|"~     The purpose of this research is to objectively compare various training modalities currently~     available in minimally invasive and robotic surgery to determine the most effective training~     methods specific to robotic cardiac surgery. We hope to recruit medical trainees with~     minimal robotic surgery training experience, randomly assigned to one of three groups (Dry~     wab, da Vinci Simulator and Wet lab). Trainees will be evaluated at baseline for a~     standardized tasks common in robotic cardiac surgery and then divided into one of the three~     training modalities. Trainees will be given sufficient time to become proficient with a~     variety of predetermined tasks unique to each training group. The trainees will then undergo~     a reevaluation with the cardiac surgery specific tasks at the end of a standard training~     period. We will then be able to compare our three groups to show if any have benefits over~     the others in regards to improvement in technical ability, understanding of the robots~     functions, efficacy of training, speed of technical skill development, accuracy and~     efficiency of movement. We will rate each modality on their reproducibility, accuracy of~     representation, and ease of set up and perform a cost analysis for each of the training~     methods.~   "
53484|NCT02357043|"~     The study aims to evaluate the accuracy of the blood glucose level results obtained from~     fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to YSI as well as~     to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons~     using only device labeling.~   "
53485|NCT02357030|"~     The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available~     medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy)~     to treat Gulf War Illness (GWI).~   "
53486|NCT02357017|"~     The purpose of the study is to test the hypothesis that persistent fluid retention and high~     sympathetic output contributes to the development of refractory hypertension (HTN). The~     investigators will determine, in a cross-over assessment of high and low salt diets, if~     dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN.~     Moreover, the investigators will determine if dietary sodium restriction lessens the~     severity of obstructive sleep apnea (OSA) in patients with refractory HTN.~   "
53487|NCT02357004|"~     The purpose of this protocol is test whether patients with hypertension refractory to~     antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system)~     activity.~   "
53488|NCT02356991|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).~   "
53489|NCT02356978|"~     Evaluating the efficacity of a new device phototherapy by comparing it with conventional~     phototherapy. Jaundice occurs in many newborns, and is, in most cases benign, However, owing~     to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to~     identify those who might develop severe hyperbilirubinemia an, in rare cases, acute~     bilirubin encephalopathy or kernicterus. Treatment of jaundice in newborn relies on~     phototherapy, exposing their skin to light of a specific wavelength . Fluorescent tubes or~     halogen lamps have been used as light sources for phototherapy for many years.~     Light-emitting diodes (LEDs) are more recent sources which are power efficient, have a~     longer life and are portable with low heat production. Several technologies and devices are~     developed using LEDs and specially a compact system.~   "
53490|NCT02356965|"~     The purpose of the study is to test two different doses of ketamine sub-lingual (under the~     tongue) wafer against placebo to see how effective the medication is to treat moderate to~     severe pain after wisdom tooth extraction.~   "
53491|NCT02356952|"~     Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin~     associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and~     other diseases, including some cancers. There has been an increased interest of researchers~     in the relationship between MetS and diet and, specifically, Mediterranean diet would be~     beneficial for people with high risk of developing MetS or individuals with established~     MetS.~   "
53492|NCT02356939|"~     Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the~     patients is made when enlisted for LT. Definitive inclusion and randomization is performed~     during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct~     diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a~     T-tube is placed into the bile duct, and removed endoscopically four to six months~     postoperative. The surgical technique is available on a movie during randomization on the~     website. The primary endpoint is the occurrence of biliary complications, including biliary~     fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are~     the incidence of complications related to the stent placement and its extraction by~     endoscopy.~      Discussion: Biliary complications following LT are significant causes of morbidity,~     retransplantation and eventually mortality. Although controversial, the use of a T-tube has~     been proven to be useless and even responsible for specific complications in many studies,~     including several randomized trials. However, several studies have identified a small bile~     duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be~     significantly associated to biliary stenosis. Our team published a preliminary study~     including 20 patients using a new technique of intraductal stenting. Only 4 complications~     were reported in the overall study population while no biliary complication occurred in the~     subgroup of patients who received a whole graft LT. Moreover, no technical failure and no~     procedure-related complications were noted before and during drain removal. Although~     intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a~     multicentric randomized controlled study is needed to validate it as a protective tool for~     biliary complications following LT.~   "
53493|NCT02356926|"~     Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical~     errors with implementation of systematic cross checkings between emergency physician.~   "
53494|NCT02356913|"~     The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess~     bioequivalence between three new nicotine gum formulations and a reference nicotine gum in~     healthy smokers.~   "
53495|NCT02356900|"~     This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric~     environment for exercise performance at altitude. Subjects will complete a short,~     high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and~     after this training phase, all subjects will be tested for maximum aerobic capacity at a~     simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers~     of mitochondrial oxidative capacity in a skeletal muscle biopsy.~      A group of individuals of similar characteristics completing this training program in a~     normoxic-normobaric environment will serve as a control.~   "
53496|NCT02356887|"~     During neurosurgical procedures, patients need to be placed in sitting position for surgical~     access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of~     sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common~     complication of sitting position craniotomy and carries high mortality and morbidity. Venous~     pressure decreases as the head of the patient is raised above the heart. Hence, negative~     venous pressure in the cerebral venous system promotes entrapment of air in accidental~     opening of the sinuses.~      Common methods to prevent VAE in sitting position include increasing the venous pressure by~     either jugular venous compression and/or increasing the venous pressure by adding positive~     end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead~     to brain swelling.. In addition, improper neck position can cause the kinking of the IJV~     which may lead to decreased venous drainage and increased ICP. This has been shown to be the~     contributing factor for intraoperative brain swelling and postoperative neck and tongue~     swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral~     position of the head, but surgery cannot always be performed with this.~      Currently, there are no studies that looked into the IJV flow in sitting position and effect~     of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with~     closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly~     used physiological methods that can cause venous outflow obstruction. A custom made neck~     collar can be used for compression of internal jugular vein and previous investigations have~     used a similar device in a rat model to demonstrate the protective effects on slosh-mediated~     brain injury by increasing intracranial blood volume . While the collars have not yet been~     studied on people for their effectiveness at preventing concussions, many studies have~     looked at the effect of neck collars on both jugular compression and ICP..~      The purpose of this study is to measure the venous blood flow of healthy volunteers by the~     use of an ultrasound and Doppler velocimetry in sitting position. the investigators will~     measure the IJV flow on both sides in sitting position at rest and at two conditions of~     venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30~     seconds Valsalva maneuver. This study will provide information on the cerebral venous~     drainage. This information will be very useful in planning and positioning of patients~     undergoing neurosurgical procedures and to prevent complications from the improper patient~     position.~   "
53497|NCT02356874|"~     The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if~     exercise can modify the disease course and prevent comorbidity in patient with~     spondyloarthritis (SpA).~   "
53498|NCT02356861|"~     The purpose of this study is to learn if an experimental treatment can help thinking~     ability, and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and~     post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial,~     light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The~     helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front~     of the head through the scalp. The participants receive a series of LED treatments which~     take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus.~     The LEDs contain near-infrared diodes. The FDA considers the LED device used here, to be a~     non-significant risk device. The LEDs do not produce heat.~   "
53499|NCT02356848|"~     This study will evaluate a comprehensive tailored behavioral intervention aimed to improve~     foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent~     ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy~     for improving self-care and early detection of foot abnormalities in this at-risk population~     using psychological theories to target multiple health behaviors simultaneously. This could~     be an efficient and cost-effective approach to improve diabetes-related foot health~     behavior, and other risk factors in patients who are vulnerable to devastating consequences~     related to amputation.~   "
53500|NCT02356835|"~     This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the~     APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.~   "
53501|NCT02356822|"~     This is an investigational multi-site outcomes registry intended to collect information~     about a patient's cancer care. Patients may enter the Registry at any time during the~     patient's current stage in the continuum of care. The registries main objectives will be to~     measure and evaluate the effects of patient care throughout the care continuum, resulting in~     the identification of the most effective treatment options. Objectives will encompass~     evaluations and analytics around safety, effectiveness, and improved efficiencies.~   "
53502|NCT02356809|"~     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in~     the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with~     systemic scleroderma~   "
53503|NCT02356796|"~     The purpose of this study is to evaluate the effect of a multidisciplinary group based~     treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The~     hypothesis is that multidisciplinary group based treatment is more effective than standard~     physiotherapy for women with CPP. The participants will be randomized to one of two~     treatment arms, and the treatment effect will be evaluated 12 months after start of~     intervention.~   "
53504|NCT02356783|"~     Our aim is to assess usability and compliance of a wireless pedometer for monitoring step~     count after a lumbar epidural steroid injection for the treatment of radicular pain in low~     back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can~     be used to measure efficacy of pain interventions.~   "
53505|NCT02356770|"~     The objective of this study is to investigate the safety and the function of the collagen~     Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of~     the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue~     augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and~     III.~      Study patients must have a single tooth gap with insufficient soft tissue volume after~     implant placement. Therefore a soft tissue augmentation will be necessary.~   "
53506|NCT02356757|"~     The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve~     foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose,~     blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at~     higher than normal risk for amputation. This novel intervention aims to improve self-care~     and early detection of foot abnormalities in at-risk patients with diabetes and poor foot~     self-care using advanced behavioral approaches to target adherence to multiple health~     behaviors, including foot self-care, self-monitoring, medication adherence, dietary~     adherence, and physical activity simultaneously. If this promising behavioral theory-driven~     approach delivered using common technology (phone) to the patient at home can work in a~     setting where improvements in foot care are so urgent, it will be an important scientific~     contribution.~   "
53507|NCT02356744|"~     Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and~     after 1 year of surgery.~   "
53546|NCT02356237|"~     This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal~     outcomes. Half of the participants will undergo selective episiotomy (according to routine~     delivery management at the particular hospital), while the other half will not undergo~     epitiotomy at all.~      Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated~     between these two groups.~   "
53508|NCT02356731|"~     Epilepsy is one of the most common neurological diseases.Approximately 53 million people~     suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million~     in 2005.~      The annual incidence of epilepsy varies considerably in different epidemiological studies,~     ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.~      To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe~     and effective, it has good daily administration frequency, easily administered from all~     roads, which has high bioavailability, which is not highly bound to proteins, and not~     holding inductive or inhibitory effect.~   "
53509|NCT02356718|"~     This study examines whether computer tasks can improve memory and other cognitive functions~     among patients receiving inpatient treatment for substance use disorders.~   "
53510|NCT02356705|"~     Midazolam is often given before surgery to sedate a patient before anesthesia is given.~     Children are often given a small dose either by mouth or squirted into the nose. Children~     will often spit out the oral midazolam, making it difficult to know how much medicine, if~     any, they have received. Giving midazolam into the nose is more reliable, but children may~     complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also~     occur when midazolam is squirted alone into the nose. The purpose of this study is to see if~     adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam~     easier and more comfortable without affecting how the midazolam works as a sedative. This is~     follow up to the pilot study, Project # 994. This will expand the previous study, with~     additional participants and revised xylocaine concentration~   "
53511|NCT02356692|"~     The purpose of this study was to investigate the overall clinical comfort performance of~     enfilcon A and senofilcon A lenses over 15-minutes of lens wear.~   "
53512|NCT02356679|"~     The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in~     Gastritis Patients.~   "
53513|NCT02356666|"~     Different definitions of nocturnal hypoventilation are used in the recent literature. The~     investigators aimed to compare the prevalence of nocturnal hypoventilation in a~     neuromuscular disease's population according to different definitions issued from the~     literature.~   "
53514|NCT02356653|"~     The goal of this protocol is to expand access for patients who lack a fully HLA (Human~     leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic~     stem cell transplant (HSCT). These patients have a serious or immediately life-threatening~     disease for which HSCT is indicated. These patients are not eligible for other Children's~     Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T~     depletion.~   "
53515|NCT02356640|"~     Patients suffering from pancreatic cancer are associated with a poor prognosis and survival~     of less than one year is expected in inoperable tumours. Management of these patients would~     be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this~     intractable pain is often difficult to treat. Different pharmacological agents have been~     used in the past to control this pain and these include non-steroidal anti-inflammatory~     drugs and narcotic agents. However, patients' responses are often variable and difficult to~     predict. Furthermore, these agents are associated with their own adverse effects and may~     further impair quality of life.~      Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches~     of performing the procedure have been described. The standard technique involves a~     percutaneous approach but CPN can also be performed by an intra-operative approach with open~     or laparoscopic means. Results from meta-analysis have shown that CPN was associated with~     superior pain relief as compared to analgesic therapy alone and reduces the need for opioids~     analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer~     adverse effects than opioid analgesics and it is the preferred method of improving pain~     relief in these patients.~      Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is~     safe and effective and was shown to be associated with long lasting pain relieve in patients~     suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon~     and are less than 2% in these series. Transient diarrhoea and hypotension are common after~     CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is~     being done by the EUS or percutaneous approach. The EUS approach offers several theoretical~     advantages over the percutaneous option. Most notably is the visualization of the celiac~     ganglia situated anterior to the aorta, allowing direct injection of the ganglia with~     alcohol resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN~     and may result in improved pain control. Furthermore, it could reduce complications~     associated with the percutaneous approach that includes lower extremity paresthesia and~     paralysis.~      Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound~     (EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis~     (CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct~     visualization and injection of the celiac ganglion, the investigators hypothesis that~     EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for~     opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.~   "
53516|NCT02356627|"~     The purpose of this study is to examine the effectiveness and cost-effectiveness of the~     Cancer Home Life Intervention compared to usual care on performance of and participation in~     everyday activities and quality of life in people with advanced cancer living at home.~   "
53517|NCT02356614|"~     This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical~     study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese~     population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up~     to 10 years after implantation.~   "
53518|NCT02356601|"~     Ultrasound is used increasingly to aid placement of neuraxial blocks. Good visibility of~     ligamentum duramater complex and posterior longitudinal ligament (LF, PLL) has a positive~     predictive value of 85% for successful neuraxial block. Dural puncture could still be~     feasible despite the absence of a good view, as reflected by a negative predictive value of~     30%.~      Poor neuraxial ultrasound view could be due to limitations of ultrasound or various other~     anatomical reasons which might include absent LF, calciﬁcation of ligaments, spinous process~     contact and presence or absence of epidural or subdural fat. This will be the first study of~     its kind to compare neuraxial ultrasound with MRI. The aim of this study is to look for~     anatomical correlation between neuraxial ultrasound and MRI at various lumbar interspinous~     levels and to look at factors that contribute to abnormal neuraxial imaging. Assuming the~     predicted abnormal ultrasound images to be around 30% and predicted abnormal MRI images to~     be 5%, 79 images should give a power of 0.9 and alpha 0.01 to analyse the association~     between the two. Sample Size Calculations were performed using statistical software R~     version 2.15.2~   "
53519|NCT02356588|"~     The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil~     Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of~     moderate-to-severe acute post-operative pain in patients after abdominal surgery.~   "
53547|NCT02356224|"~     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an~     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose~     study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in~     healthy subjects.~   "
56187|NCT02321670|"~     A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision~     and primary anastomosis or with an onlay grafting procedure using buccal mucosa.~   "
53520|NCT02356575|"~     The aim of this study is to determine which of two treatments (acupuncture or cognitive~     behavioral therapy) works better for treating insomnia in cancer survivors. The investigator~     also wants to study the factors that might impact why someone might prefer or do better in~     one treatment over the other.~      Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very~     thin needles inserted in the skin to treat different symptoms and illness, and to promote~     healing.~      Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to~     address behaviors and thoughts that are known to effect problems with sleep.~   "
53521|NCT02356562|"~     The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r and~     dasabuvir with or without Sofosbuvir and RBV in DAA treatment-experienced adults with~     Genotype 1 Chronic Hepatitis C Virus infection.~   "
53522|NCT02356549|"~     The purpose of this study is to determine if the use of tailored health messages and/or~     involving physicians are effective in increasing African American (AA) patient activation in~     a clinical trial consultation. The proposal will use a composite score for patient~     activation derived from the Street Patient Activation Coding system. This will help to~     determine the effectiveness of our intervention on patient activation and patient centered~     clinical trial decision.~   "
53523|NCT02356536|"~     The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment~     for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use~     of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the~     resumption of normal walking. It is designed for use in PD patients with FOG, in their home~     environment where FOG is most severe. Kinematic data will be logged by a memory card in the~     belt worn device recording FOG, and falls. The device will be used on 3 different settings~     in a gait laboratory environment, and then for 2 weeks in the patient's own home using the~     same 3 settings. A battery of psychometric instruments will be administered before and after~     the trial~   "
53524|NCT02356523|"~     The Purpose of this study is to evaluate the incidence of delirium in Cardiac Intensive Care~     Unit Patients.~   "
53525|NCT02356510|"~     The current guidelines still recommend emergent PCI of the culprit lesion and state that~     primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock~     and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is~     based on a high number of studies. However, several studies are present about the safety and~     efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly~     going on about the PCI of the non-culprit arteries during the index event with newer~     prospective randomized studies. Besides, it is still unclear for the culprit artery whether~     to treat only the culprit lesion or all the other lesions in the culprit vessel during the~     index event. The present report describes a retrospective comparison between the two~     strategies during primary PCI for STEMI, looking for their influence on the clinical and~     angiographic course of the patients.~   "
53526|NCT02356497|"~     Bone metastases are frequent distant manifestations of cancer, with pain as a common and~     devastating consequence. The primary treatment for painful bone metastases, external beam~     radiation therapy, is moderately effective: about 60% of patients who undergo conventional~     radiotherapy experience (partial) pain relief. Several factors associated with treatment~     failure have been identified, but no attempts have been made to collapse these factors into~     a clinically useful prediction tool to predict treatment response. In addition, to aid in~     therapy selection based on expected survival time, development of survival models is~     essential. Finally, we need innovative treatments as alternatives or additive to standard~     treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT~     cohort study, recruiting patients at the departments of radiation oncology and orthopedic~     surgery.~      We aim to provide detailed information about clinical data, create an infrastructure for~     efficient, fast and pragmatic evaluation and implementation of innovative interventions, as~     well as development of accurate new prediction tools.~   "
53527|NCT02356484|"~     The aim of this study is to evaluate the predictive value of albumine, C-reactive protein~     (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative~     complications. These biomarkers will be measured from the day before surgery until~     postoperative day four in patients undergoing major surgery. Major surgery was defined as~     esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures~     including an organ resection for benign or malignant disease and lasting more than 2 hours.~   "
53528|NCT02356471|"~     This pilot clinical trial studies how well consumer-based activity monitor works in~     evaluating and measuring activity of older patients with abdominal cancer undergoing~     surgery. Consumer-based activity monitor (CAM) may identify patients who are at-risk for~     increased post-surgery medical problems. With early identification of at-risk patients, CAM~     provide supervised exercise in the preoperative and postoperative periods to improve over~     mobility and potentially decrease preoperative complications among patients undergoing major~     abdominal surgery.~   "
53529|NCT02356458|"~     Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no~     standard therapeutic options in case of relapse. Prolongation of remissions or induction of~     longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal~     inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown.~     These findings, along with the reported single agent activities of both drugs and the~     non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in~     this trial~   "
53530|NCT02356445|"~     Retrospective review of the outcome of use of immunosuppressive drugs in treatment of~     sarcoidosis~   "
53548|NCT02356211|"~     Objective To reduce subsequent falls following Multifactorial Falls Assessment Design:~     Prospective Case Control~      Population: Frail elderly Veteran outpatient population referred for falls assessment~      Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic~     patients followed for 1 year and outcomes compared to Falls e-Consult Clinic (chart review)~     and Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control groups.~   "
53549|NCT02356198|"~     This study is prospective, randomized trial in which EXPAREL TAP block is compared to~     standard IT opioid administration, in relieving postoperative pain, decreasing length of~     stay, and use of narcotic medication.~   "
83574|NCT01963455|"~     This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for~     the treatment of stress urine incontinency (SUI) in women.~   "
53531|NCT02356432|"~     Anticoagulants are generally recognized as a necessary therapy to prevent the recurrence of~     ischemic stroke in patients with non-valvular atrial fibrillation (NVAF), but in some~     patients they also cause bleedings, particularly intracranial hemorrhage. One of the~     independent predictors of intracerebral hemorrhage is the presence of cerebral microbleeds~     (CMBs); a high incidence of intracerebral hemorrhage is reported in patients with multiple~     CMBs. Recent study suggested that patients who had CMBs at baseline developed more new CMBs~     after 2 years (26%), compared with patients (12%) who did not have CMBs at baseline.~     However, there has been no study on the progression of CMBs in patients receiving so-called~     novel oral anticoagulants (NOACs).~      This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in~     patients receiving NOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) than in those~     receiving warfarin, and this difference reflects the difference in the effects of warfarin~     and NOACs on the progression of CMBs. Towards this goal, we enroll 200 patients with at~     least one CMB detected by 1.5 T MRI (T2*WI) at baseline, who treated with NOACs or warfarin~     for 12 months. Primary endpoint is the proportion of subjects with an increased number of~     CMBs at Month 12 of treatment with NOACs or warfarin. If the results of this study support~     the efficacy of NOACs in preventing increase of CMBs, this would be of great interest to~     domestic and overseas clinicians, in view of the potential therapeutic impact, including~     that for primary prevention of ischemic stroke.~   "
53532|NCT02356419|"~     The study is a single center and open test, and the dose of successive incremental method~     was taken. In order to determine the tolerance and safety after a single intravenous~     injection of different doses of rESP in healthy subjects, the investigators had this trial.~     On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy~     subjects.~   "
53533|NCT02356406|"~     This prospective study evaluates celiac plexus radiosurgery for pain control in patients~     with upper abdominal malignancies.~   "
53534|NCT02356393|"~     Association between serum magnesium and clinical outcome in patients with acute MI (AMI)~     with 1 year follow-up in 300 patients in regions supplied by desalinated drinking water~     (DSW) (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW)~     (Nahariya MC).~   "
53535|NCT02356380|"~     To determine the affects of Physical Therapists clinical reasoning using thoracic spine~     mobilization for neck pain compared to a standard protocol.~   "
53536|NCT02356367|"~     The purpose of this study is to determine the predictive factors of poor compliance to sleep~     disordered breathing therapy in chronic heart failure patients treated for central sleep~     apnea. To characterize nocturia pathophysiology associated with SDB in this population. To~     use telemonitoring data to define predictive factors of poor compliance.~   "
53537|NCT02356354|"~     The aim of this study is to understand why the regeneration of the cutaneous sensory nerve~     fibers is poor in post-burn scar.~      The presence or the lack of several molecular factors known to regulate neuronal cell~     development will be evaluate and compared within biopsies from healthy skin and post-burn~     scar.~   "
53538|NCT02356341|"~     This observational study is intended to collect outcome data from a cohort of 90 patients~     suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are~     treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.~   "
53539|NCT02356328|"~     This observational study is intended to collect outcome data from a cohort of 30 patients~     suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who~     are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.~   "
53540|NCT02356315|"~     New advances in medical imaging have allowed for the measurement of brain activity related~     to chronic pain. In addition to the brain, the investigators aim to use functional magnetic~     resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy~     subjects and chronic neck pain patients. The information gained from this study will~     increase the investigators understanding of how chronic pain is encoded in the nervous~     system and assist in developing more effective treatment strategies.~   "
53541|NCT02356302|"~     Research is currently underway to develop new HIV prevention strategies. Intravaginal rings~     (IVRs) are one drug delivery method that is currently being studied. This study will~     evaluate the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a~     combination of vicriviroc/MK-2048, in healthy, HIV-uninfected women.~   "
53542|NCT02356289|"~     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and~     pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind,~     placebo-controlled, sequential group, single ascending (oral) dose study in healthy~     volunteers aged 18-55 years.~   "
53543|NCT02356276|"~     The purpose of this study is to study the efficacy of hyperthermic intraperitoneal~     chemotherapy in the treatment of patients with locally advanced gastric cancer after radical~     gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.~   "
53544|NCT02356263|"~     Stressors impair optimum function of an individual physiologically and psychologically.~     Overcoming stress is possible when one knows which aspects of life are the most troublesome~     to manage for individuals. There are certain tools available in Pakistan that can measures~     stress in selected populations but there are no validated tools that may quantify stress~     which results from events occurring in different aspects of life.~      Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals~     through life changing events. It has five categories; work, home and family, health,~     personal and social and financial. The objective of the study is to adapt RLCQ and validate~     it so that it may measure stress among people living in Karachi, Pakistan.~   "
53545|NCT02356250|"~     Rationale for the study:~      To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a~     correlation between HVPG result and PEF result in a way that the result of the PEF test will~     be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable~     office-based device that can produce immediate results in a non-invasive manner in cirrhotic~     patients and help in evaluating prognosis in these patients in a noninvasive manner.~      Aim:~      The aim of this study is to try and characterize the peripheral endothelial function (PEF)~     in patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every~     patient before evaluating his HVPG level in a hemodynamic study.~   "
53550|NCT02356185|"~     Background:~      Data are scarce concerning injecting drug use (IDU) and alcohol consumption among~     HIV-infected people on highly active antiretroviral treatment (HAART) in Cameroon. The aim~     of this study is to determine the prevalence of alcohol consumption and IDU among~     HIV-infected people on HAART; to determine sociodemographic factors associated with alcohol~     abuse and IDU among people on HAART; and to determine impact of alcohol consumption and IDU~     on adherence to HAART.~      Methods/Design:~      The investigators will conduct a cross sectional study at the Yaoundé Central Hospital in~     Cameroon, from February to August 2015. Using a self-report questionnaire, the investigators~     will include at least 1,000 HIV-infected adults (18 years or more) on HAART for at least one~     month coming for HIV care. The investigators will exclude pregnant women. Data collection~     will include sociodemographic and economic profile, alcohol consumption using Alcohol Use~     Disorders Identification Test, injecting drug use, adherence to HAART using visual analog~     scale and self-rate report. The investigators will perform sub-analysis for sex group and~     area of habitation. A p value < 0.05 will be considered statistically significant.~      Discussion:~      There is a critical need of accurate estimates of the amplitude and the distribution of IDU~     and alcohol consumption among HIV-infected adults, in order to inform health policies maker~     for curbing burden of both injecting drug use and alcohol consumption among people living~     with HIV.~   "
53551|NCT02356172|"~     Background:~      - Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go~     through puberty late. Some never reach puberty or don t complete it without treatment. They~     also may have an impaired sense of smell or other health problems. Research shows that~     disorders like this can have a negative effect on a person s psychological profile.~      Objective:~      - To understand the psychological outcomes in people with IGD. These can include depression,~     anxiety, poor health, and poor social function.~      Eligibility:~        -  Adults age 18 and over with IGD. They must be currently on a full dose of hormone~          replacement therapy for at least 3 months.~        -  Healthy adult volunteers.~      Design:~        -  Participants will get a username and password. This will give them access to questions~          online. They can do this from any computer connected to the Internet.~        -  Participants will log in and complete the questionnaires. There are 5 total, but they~          will appear as 1 continuous set of questions. Answering them takes about 1 hour or~          less.~        -  The first set is about the participant s disorder. The rest ask about depression,~          anxiety, global health, and social function.~        -  All answers will be used for research and to better understand reproductive disorders.~          Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from~          this study will know which answers belong to which participant.~   "
53552|NCT02356159|"~     Background:~      - In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given~     to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor~     immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This~     is less likely when the recipient and donor have similar human leukocyte antigens (HLA).~     Researchers want to see if the drug palifermin improves the results of allogeneic SCT from~     HLA-matched unrelated donors.~      Objective:~      - To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and~     improve immune function after transplant.~      Eligibility:~      - Adults 18 70 with blood or bone marrow cancer with no HLA-matched sibling, but with a~     possible HLA-matched donor.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have scans and heart and lung exams.~        -  Before transplant, participants will:~        -  Have many tests and exams. These include blood tests throughout the study and bone~          marrow biopsy.~        -  Get a central line catheter if they do not have one.~        -  Have 1 3 rounds of chemotherapy.~        -  Take more tests to make sure they can have the transplant, including medical history,~          physical exam, and CT scan.~        -  Get palifermin by IV and more chemotherapy. They will get other drugs, some they will~          take for 6 months.~        -  Participants will get the SCT.~        -  After transplant, participants will:~        -  Be hospitalized at least 3 4 weeks.~        -  Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and~          biopsies.~        -  Stay near D.C. for 3 months.~        -  Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.~   "
53553|NCT02356146|"~     Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be~     explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for~     patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing~     CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose~     administration prior to kidney transplantation.~      Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of~     tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients~     with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression~     were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage~     which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were~     recorded.~      The genotyping, TacC12, and target tacrolimus dosage have good correlations.~   "
53554|NCT02356133|"~     record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ~     disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in~     Endovascular Neurosurgery~   "
53555|NCT02356120|"~     The purpose of this study will be to evaluate the measurement of tricuspid annular plane~     systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with~     suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the~     pulmonary arteries (CTPA)~   "
53556|NCT02356107|"~     The investigators hypothesize that the administration of two widely available, naturally~     occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the~     severity of depression in individuals exposed to chronic hypoxia by living at altitude. The~     purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g~     creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms~     measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or~     SNRI-resistant depression.~   "
53557|NCT02356094|"~     Characterization of posterior corneal changes in primary open angle glaucoma patients, using~     Scheimpflug examination.~   "
53558|NCT02356081|"~     Chemotherapy may cause distressing symptoms which can impact on patients' quality of life.~     Chemotherapy is frequently given on an outpatient basis therefore patients are often~     required to manage the symptoms they experience at home without direct supervision from~     healthcare professionals. This study aims to evaluate the impact of a mobile phone based,~     remote monitoring, symptom management system (ASyMS) on the delivery of care to people with~     nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one~     year following treatment. The study aims to compare a number of outcomes of patients using~     the ASyMS intervention with outcomes of patients who receive normal care at their hospital.~     Throughout chemotherapy treatment, once a day and any other time they feel unwell, patients~     allocated to the mobile phone group will enter information on the phone regarding any~     symptoms they are experiencing, take their temperature and enter this on the phone. The~     information is sent via secure connection to a computer, which assesses the information and~     sends an alert to their health care professional in the hospital, who will call the patient~     at home if the patient has reported problematic symptoms. Patients in the normal care group~     will receive care as normal at their hospital. Both groups of patients will be asked to~     complete a series of questionnaires before they start treatment, after each chemotherapy~     cycle and at 3, 6, 9, 12 months after treatment completion (a subset of patients will also~     be asked to complete midcycle symptom assessments). The study will also evaluate the cost~     benefit of ASyMS, assess changes in clinical practice as a result of ASyMS and develop a~     predictive risk model (statistical model) for use in future care of patients receiving~     chemotherapy for these cancers. This multicentre study is taking place across a number of~     European countries.~   "
53559|NCT02356068|"~     Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests~     (INR, platelets count) can not predict bleeding or blood product requirements during liver~     transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole~     blood coagulation generation and lysis. TEM results are available more rapidly than~     conventional tests and give additional information regarding coagulation strengh, platelet~     function, and fibrinolysis.~   "
53560|NCT02356055|"~     People with Alzheimer's disease and related dementias present with changes in how they~     think, move and emotionally respond to daily life situations. While type of dementia will~     dictate how severe certain symptoms are, all people with dementia will report a gradual~     change in how they function in daily life skills. Losing the ability to do daily life tasks,~     such as using a cell phone, balance a checkbook or get dressed in the morning signifies loss~     for both the person with dementia and their caregiver. Caregivers that assist with daily~     life tasks report more depression and anxiety, as well as a higher burden of care. People~     with dementia that lose the ability to perform daily tasks report more depression and~     decreased satisfaction with life. Despite gains in research, researchers are still missing~     important pieces that will improve rehabilitation interventions for improving daily life~     skills.~      In order to address the needs of people with dementia, an intervention called Skill-building~     through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our~     team proposes that improvement in daily life skills is possible under certain circumstances.~     First, the daily life task a person is addressing in rehabilitation should be~     personally-meaningful and should also be the task practiced in therapy which is called~     task-oriented training. For example, a person that is having trouble making a sandwich~     should practice making a sandwich. Second, the investigators propose that people with~     dementia need a lot of correct practice so that the brain has time to rewire how to do~     the task correctly. Therefore, when patients practice tasks using STOMP, investigators do~     not allow our participants to make errors and patients practice for long periods of time.~     Investigators also incorporate and provide new technology into training such as medication~     reminder alarms and photo phones which allow you to dial a number by choosing a loved one's~     picture.~      In this pilot study, the investigators want to look more closely at the how the amount of~     time you practice influences study outcomes. The investigators believe that the findings~     from this study will support our belief that more time in therapy is needed to enhance how~     someone with dementia learns.~   "
53561|NCT02356042|"~     The study aimed to compare the changes in health and functional status between nursing home~     residents practicing GIA activity and a control group of residents, and to examine the~     changes in residents' abilities to participate in GIA activity.~   "
53562|NCT02356029|"~     The primary objective of this study is to determine how often cardiopulmonary resuscitation~     (CPR) is perceived as inappropriate by Healthcare Providers (HCPs) working in prehospital~     Ambulance Services and Emergency Departments. Perception of inappropriate CPR is defined as~     resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the~     patient in terms of survival or quality of life.~      When a HCP perceives CPR as inappropriate, this may cause moral and emotional distress. This~     perception may be modulated by the personal background and professional role of the HCP, but~     also by his/her working conditions. Apart from the workload, the resulting distress can be~     influenced by the way non-technical skills are developed within the team and the ethical~     environment in which the HCP functions. Frequent exposure to similar patient care situations~     and/or a professional environment not acknowledging the distress may lead to deficient~     coping mechanisms and accumulation of moral distress. This may be associated with job leave,~     burnout and a decreased quality of patient care. Acute distress may also influence the~     quality of care provided to actual and future patients.~      Secondary objectives of the study are to evaluate whether perceived inappropriateness of CPR~     is not only associated with patient related factors but also with personal characteristics~     and work related factors. Potential consequences for HCP's like moral distress and~     intentional job leave will be assessed.~   "
53563|NCT02356016|"~     The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS)~     and/or nutritional on body composition and functional tasks in elderly females with~     sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and~     older with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a~     WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS~     protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy~     based on a high protein supplement.~   "
53564|NCT02356003|"~     Tics are the core symptom of Tourette syndrome. These are repetitive, sudden, semi-voluntary~     movements or sounds. In some children, these tics can be especially bad and require~     treatment, however, options are limited. It is only with time and practice that youth with~     Tourette syndrome are better able to suppress their tics. For these reasons, new~     interventions are needed. The investigators will target a brain region involved in tics~     called the supplementary motor area. Using low frequency repetitive transcranial magnetic~     stimulation, the investigators will inhibit the activity, in a similar way to the tic~     suppression that develops with age. The investigators propose the following objectives: (Aim~     1) The investigators hypothesize that Tourette syndrome symptom severity (as measured by the~     Yale Global Tic severity Scale) will decrease with low frequency repetitive transcranial~     magnetic stimulation targeting the supplementary motor area. (Aim 2) The investigators~     further hypothesize that improvement in Tourette syndrome symptoms will be moderated by low~     frequency repetitive transcranial magnetic stimulation induced changes in GABA and glutamate~     in the supplementary motor area, and changes in the functional connectivity between the~     supplementary motor area and primary motor cortex. Eleven children (7-12 years of age) with~     Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation~     (five times a week for three weeks). After the three weeks, they will look for changes in~     tic severity and brain chemistry and function. By developing a novel avenue for treating~     Tourette syndrome, they can directly impact the care of children by reducing the severity of~     tics and improving quality of life.~   "
53567|NCT02355964|"~     This project aims to study the effects of lifestyle changes on asthma and systemic~     inflammation in a randomized clinical trial of diet and exercise. The project is a~     multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred~     on improving asthma control in non-obese sedentary asthmatics via simple means.~   "
53568|NCT02355951|"~     Objectives:~      Primary Objective:~      To identify and preselect patients with chronic HBV mono infection, who are undetectable for~     anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the~     TG1050.02 Phase1/1b First in Man (FIM) study.~      Secondary Objectives:~      To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.~      Methodology:~      Patients with chronic HBV mono-infection, who are currently being treated with~     nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb~     levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will~     be measured by a central laboratory using a newly validated assay.~   "
53569|NCT02355938|"~     The primary purpose of this study is to compare the clinical outcomes of cure and recurrence~     of Clostridium difficile infection in spinal cord injured patients who are treated with oral~     Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall~     costs of treatment of Clostridium difficile infection in the two study groups.~   "
53570|NCT02355925|"~     The present study is designed as a pilot study with 150 patients in each group. Data~     collection form will be filled by the researcher who does not know the type of intervention~     in each group. Data analysis will be done through descriptive and perceptive statistical~     methods by using SPSS software version 20 for windows~   "
53571|NCT02355912|"~     The purpose of this study is for transfemoral amputees to walk with an experimental robotic~     prosthesis. Electric signals will be measured from their muscles and used to help control an~     artificial leg. The investigators will record from sensors placed on a prosthesis and~     electric signals measured from muscles in the participants leg to see if the investigators~     can develop better computer programs to help predict subject actions and prostheses~     function.~   "
53572|NCT02355899|"~     This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in~     patients with distal subungual onychomycosis of the great toenail. Patients will receive~     four PDT treatments with PD P 506 A in weekly intervals.~   "
53573|NCT02355886|"~     This randomized clinical trial studies gabapentin in reducing the need for pain medication~     in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue~     and organs. Gabapentin may reduce the amount of pain medicine required after surgery,~     improve pain after surgery, and/or reduce the length of hospital stay after surgery.~   "
53574|NCT02355873|"~     CRRT patients are generally critical ill patients with unstable conditions, such as low~     blood pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even~     two or more organ failure. CRRT serves as an important supportive therapy.Continuous~     anticoagulation is needed to prevent treatment interruptions due to clotting of the~     extracorporeal circuit. Unfractionated heparin or low molecular weight heparin both increase~     the risk of bleeding and heparin induced thrombocytopenia in such cases.However, the problem~     of CRRT without anticoagulation is the early filter clotting. An alternative method is the~     use of heparin coated hemofilter. The AN69 ST hemofilter, a surface-treated~     polyacrylonitrile membrane hemofilter, allows irreversible fixing of heparin to filter~     membrane, is able to reduce thrombogenic properties of the membrane. In this study, we~     observe the efficacy and safety of heparin-coated AN69 ST hemofilter in CRRT patients, and~     compare to the original AN69 membrane hemofilter.~   "
53575|NCT02355860|"~     In an urban gynecology practice serving patients with publicly and privately funded~     insurance, female sexual dysfunction was associated with low income, depression, urinary~     incontinence, and sexual inactivity.~   "
53576|NCT02355847|"~     Additional educational training lectures were provided to healthcare workers. Outcome~     measure of cultural competency was completed to assess patient safety, risk management, and~     cultural competency of healthcare providers in an urban academic Labor and Delivery Unit.~   "
53577|NCT02355834|"~     Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and~     causes bouts of diarrhoea which are hard to control. Over a quarter of patients experience~     extremely distressing faecal incontinence (FI). Even when the disease is in remission, the~     majority of patients live in fear of not finding a toilet in time. This curtails their~     activities and quality of life. The National Institute for Clinical Excellence (NICE 2007)~     has issued national guidance on actively asking patients about FI and a step-wise care plan~     for managing FI. However, this has not been evaluated in people with IBD, the vast majority~     of whom do not ask for help, even when they have frequent FI.~      Across six expert centres in the UK, the investigators will perform 3 linked studies: [1]~     The investigators will screen people with IBD, offering the opportunity to obtain help with~     bowel control. The investigators will compare uptake of a postal approach versus response to~     a proactive face-to-face asking approach at a physical or telephone clinical appointment.~     [2] The investigators will conduct a randomised controlled trial (RCT) comparing two~     different approaches (IBD nurse specialist plus self-help booklet versus self-help booklet~     alone) to see which one produces the best results in terms of reductions in FI, other~     symptoms, costs and quality of life at 6 months after intervention. Booklet group~     participants may access the nurse intervention at 6 months if they wish, when the RCT is~     finished. [3] Interviews will be performed at the end of the intervention, gathering patient~     views and preferences and staff perspectives via Qualitative interviews and free text~     questionnaire comments, to enable a rich understanding and interpretation of our results.~      The investigators will disseminate the results widely to people with IBD and health~     professionals and take active steps to embed successful interventions in NHS services,~     having gained sound evidence on how many people want help, whether intervention is effective~     in improving FI, and patient and staff views on interventions.~   "
53578|NCT02355821|"~     This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1~     C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.~   "
53579|NCT02355808|"~     Lack of internet infrastructure, personal skills, and service provision have been identified~     as potential barriers to e-health but as yet there is no good evidence of the impact of~     interventions to improve them. This study aims to assess impact on e-health uptake of three~     interventions (i) superfast broadband, (ii) a tailored leaflet to help participants improve~     personal internet skills and support, (iii) GP interventions to improve health service~     provision of e-health. In a cluster randomised factorial controlled trial, 1388 households~     from 78 postcodes were randomly selected from the 20088 Cornish postcodes and allocated to~     the 8 (2X2X2) arms of the study. Comparison of 'e-health readiness' and 'miles travelled'~     from baseline to 18 month follow-up between the 8 arms of the study, will be used to assess~     the effects of interventions, singly and in combination.~   "
53581|NCT02355782|"~     The purpose of this compassionate use study, for two patients with thrombotic~     microangiopathy, is to provide expanded access to patients who have participated in the~     clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed~     while on treatment or to patients who could otherwise benefit from the treatment. This is a~     treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001~     deemed eligible by the investigator may participate.~   "
53582|NCT02355769|"~     Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine.~     The progress course of HF is with increasing frequency of subsequent hospitalizations~     (approximately 30% of hospitalizations are the repeated ones). It is estimated that the~     costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients.~     The difficulty in treatment of patients with HF deterioration is associated with numerous~     comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease,~     lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as~     operations, in particular emergency ones). Our study is aimed to evaluation the complex~     pathophysiological background related to heart failure deterioration with respect to the~     effect of applied in-hospital treatment.~   "
53583|NCT02355756|"~     This will be a single center, open-label study in healthy male subjects between 18 and 45~     years old to determine the dose response profiles of dermal blood flow in response to~     intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and~     time finding and Part II: reproducibility over time.~   "
53584|NCT02355743|"~     The primary research question is, in patients with short bowel syndrome requiring central~     venous access device (CVAD) for long-term total parenteral nutrition, is once weekly~     recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine~     care using heparin flushes in reducing the incidence of line-associated thrombosis and~     infection.~   "
53585|NCT02355730|"~     This study is to further develop and optimise the design and manufacturing process of a~     handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug)~     therapy. The device comprises of a handheld instrument and a disposable test strip and~     reports how blood coagulation is working in terms of standardised units called International~     Normalised Ratio (INR). A single drop of fresh whole blood and plasma will be added to the~     strip and the INR result displayed on the instrument. Blood samples are to be collected from~     patients attending a hospital based INR clinic who are on Warfarin Therapy. The samples are~     to be used in a series of experiments in the laboratory to test the Microvisk POC INR~     Monitors accuracy, precision, stability and robustness.~   "
53586|NCT02355717|"~     The proposed research brings together complementary expertise to systematically elucidate~     the longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment~     that accompanies obesity on bone development during growth. The contribution of this~     research will be significant because it will provide a solid foundation for understanding~     the influence of fat (total and regional distribution) on overall bone strength, and whether~     insulin resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be~     underpinning factors in the fat-bone strength relationship via effects on bone modeling~     activity. This knowledge will provide critical information needed to maximize potential~     therapeutic interventions to counter the linked risks of obesity and osteoporosis, both~     major public health concerns.~   "
53587|NCT02355704|"~     Renal Insufficiency is a priority disease in health system, which may require renal~     replacement therapy based on renal transplantation, which is considered as therapy of~     choice. During the procedure of renal transplantation, the graft could be damaged by~     ischemia-reperfusion which generates complications in its function.~      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,~     which could be beneficial in renal transplantation.~   "
53588|NCT02355691|"~     For the target population of adult patients following primary total hip arthroplasty, the~     randomized clinical trial will be used to evaluate the efficacy of the use of a mobile~     negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in~     the immediate postoperative period. We will apply two dressing types and evaluate the~     postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple~     variables of wound infection risk.~   "
53589|NCT02355678|"~     Tonsillectomy is one of the most frequent surgical operations performed in children [1-4].~     It is usually associated with postoperative nausea and vomiting (PONV) with an incidence~     ranging from 23% to 73% [2]. Dexamethasone has been shown to be effective in reducing PONV~     after tonsillectomy using standardized anesthetic technique [2, 5-7]. Previous studies~     utilizing a different technique, the pre-incision infiltration of local anesthesia, had~     shown to decrease post-tonsillectomy pain, reduce analgesic consumption and provide a rapid~     return to normal activity [8, 9]. Given the effectiveness of dexamethasone and the~     pre-incision infiltration anesthetic technique, it would be beneficial to compare the effect~     of each on PONV.~   "
53590|NCT02355665|"~     The purpose of this study is to assess the efficacy and safety of a novel nicotine product~     for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments~     of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.~   "
53591|NCT02355652|"~     The goal of this prospective randomized double-blind study is to compare clinical and~     radiological results of cemented and uncemented total knee arthroplasty (TKA).~      Two hundred and fifty patients will be randomized in two groups : cemented TKA and~     uncemented TKA.~      The primary outcome is the comparison of the International Knee Society (IKS) Score revised~     in 2011 at one year postoperative.~      The second outcome is the comparison of standard one year-postoperative x-rays looking for~     signs of loosening.~   "
53592|NCT02355639|"~     The purpose of this study is to assess steroid induced skin atrophy by sonography.~   "
53593|NCT02355626|"~     Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response~     to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the~     neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of~     anxiety in critically ill patients has never been done. Our hypothesis is that high levels~     of anxiety at ICU admission are associated with death or the occurrence of one or more organ~     failure during the first 7 days, and that anxiety should be considered as a warning sign~     in critically ill patients.~   "
53595|NCT02355600|"~     Survival in young patients with cancer has increased and also have increased the adverse~     long-term side effects of chemotherapy, there is a large number of women who experience loss~     of ovarian function without accomplishing their reproductive desire due to gonadotoxic~     treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation~     in fertility preservation treatments as well as in assisted reproduction techniques.~     Improving this reserve by avoiding its depletion during the process could result in increase~     fertility rates after cancer treatment.~      Collecting follicles during tamoxifen treatment would increase the number of cryopreserved~     oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due~     to age, chemotherapy and length of treatments.~      The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen~     in breast cancer patients to improve the probability of subsequent pregnancy.~   "
53596|NCT02355587|"~     The EXPAND Registry Study follows patients with cutaneous melanoma who have had the~     DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data~     will be collected through review of medical records from clinical visits with physician.~      The purpose is to document the clinical application of results obtained from the DecisionDx-~     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma~     testing has been completed. Additionally the study will assess the health economic impact of~     DecisionDx-Melanoma testing as it relates to the Melanoma population.~   "
53597|NCT02355574|"~     The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the~     DecisionDx-Melanoma gene expression assay performed. Data will be collected through review~     of medical records from clinical visits with physician.~      The purpose is to document the clinical application of results obtained from the DecisionDx-~     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma~     testing has been completed. Additionally the study will assess the health economic impact of~     DecisionDx-Melanoma testing as it relates to the Melanoma population.~   "
53598|NCT02355561|"~     The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on~     the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test~     formulation in healthy elderly participants.~   "
53599|NCT02355548|"~     This study is looking at the safety and effectiveness of treating Patients diagnosed with a~     low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard,~     in-patient hospitalization. Patients have several medical tests done during their Emergency~     Department visit. Based on those tests, those who are determined to have a low-risk PE are~     eligible to participate in the study. Those choosing to participate are discharged after 12~     hours of medical observation. Patients who choose to participate are followed up by~     telephone approximately 90 days later.~   "
53600|NCT02355535|"~     This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a~     small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer~     cells, in patients with advanced malignancies. PAC-1 is taken orally on days 1-21 of a~     28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined~     using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease~     progression, unacceptable toxicity, physician discretion, or patient refusal.~   "
53601|NCT02355522|"~     This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing~     saline infusion sonohysterography (SIS) will be recruited and randomized into three groups~     to receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline;~     (b) 3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY~     jelly on the cervix and 5mL of intrauterine normal saline prior to SIS. Pain levels will be~     recorded to evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion~     in reducing pain during the SIS.~   "
53602|NCT02355509|"~     Is a randomized, double-blind, placebo-controlled trial to determine the behavior of~     hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with~     carbohydrate intolerance treated with acarbose.~   "
53603|NCT02355496|"~     This is a clinical trial to evaluate the impact of presenting medicare fee data for~     inpatient laboratory tests in the electronic health record on provider ordering behavior at~     a tertiary care hospital.~   "
53604|NCT02355483|"~     The purpose of this study is to determine whether non-contrast abdominal computed tomography~     (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients~     admitted to the emergency department with abdominal pain.~   "
53605|NCT02355470|"~     This study will offer the first formal assessment for sexual violence (SV) in the college~     student health center setting, developed for a high risk group of college students, and is~     designed to facilitate patient and provider comfort in discussing sexual violence and~     related abusive experiences (including the role of alcohol) via semi-scripted screening~     tools. The intervention specifically involves the training of all clinical staff (health~     educators, counselors, medical assistants, nurses, and clinicians) to deliver a universal~     education and brief counseling intervention titled GIFTSS (Giving Information for Trauma~     Support and Safety) to all clients seeking college health services integrated into usual~     clinical practice, provide universal education about SV regardless of disclosure, counsel~     clients on harm reduction strategies to reduce risk for SV, and provide supported referrals~     to sexual assault advocates, with the goal of reducing SV among college students.~   "
53606|NCT02355457|"~     The primary aim of the study is to investigate new cardiac biomarkers and algorithms to~     diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.~   "
53607|NCT02355444|"~     Cardiovascular disease (CVD) is the most common cause of death in Ireland, accounting for~     33% of all deaths. Hypertension or elevated blood pressure, is also a significant health~     problem, however, it is one of the major controllable risk factors associated with CVD.~     While increased consumption of fruit and vegetables is associated with reduced risk of CVD,~     evidence is accumulating that consumption of berry fruits in particular, may promote~     cardiovascular health. Blackberries have a favourable nutritional profile, in that they are~     rich in dietary fibre, vitamins C, K and folate but low in dietary fat and kilocalories. In~     addition, blackberries are a rich source of antioxidants, and contain numerous~     phytochemicals including polyphenols. The aim of this study is to investigate the potential~     beneficial effects of blackberry consumption on cardiovascular health, in particular,~     effects on blood pressure.~   "
53608|NCT02355431|"~     The purpose of this study is to determine if INCB039110 in combination with erlotinib is~     safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that~     is Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.~   "
53609|NCT02355418|"~     This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops~     in response to chronic volume overload from severe degenerative mitral regurgitation. The~     investigators will investigate the functional (exercise) and symptomatic (PROMS) outcomes of~     patients with severe but asymptomatic mitral regurgitation who have the option of choosing~     surgical repair or watchful waiting.~   "
53610|NCT02355405|"~     Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing~     perioperative atelectasis and evaluating its severity in adult patients undergoing general~     anesthesia in the operating room.~   "
53611|NCT02355392|"~     The purpose of this study is to determine the prevalence of hypertension among citizens of~     Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the~     insufficiently treated, and to estimate the prevalence of white coat and masked hypertension~     using home blood pressure measurements with telemedical data transmission.~   "
53612|NCT02355379|"~     Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France~     more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more.~     Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall~     survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is~     poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is~     suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly~     patients in this study were highly selected and patients older than 80 represented only 0.7%~     of the total population. Thus, there is still a concern about the benefit of adjuvant~     5FU-based chemotherapy in very elderly unselected patients.~      The recommended treatment for stage III adjuvant chemotherapy is a combination of~     fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival~     advantage in elderly patients.~      Altogether there are still two matters of debate:~        -  First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit~          elderly patients?~        -  Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly~          patients? The aim of this randomized phase III study is to evaluate the benefit for~          disease-free survival of adjuvant chemotherapy in elderly patient and which~          chemotherapy.~      The elderly patient population will be dichotomized into two groups according to physician's~     choice after a multidisciplinary evaluation involving a geriatrician, with two different~     randomization assignments. The patients with an expected life-expectancy below 4 years~     according Lee score are excluded of this study.~      Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch~     repair deficiency), therefore an evaluation of specific biological prognostic factors is~     needed in elderly population.~   "
53613|NCT02355366|"~     The present study aims to examine the effects of a 4 month, family focused therapy (FFT)~     intervention on the 1 year course of mood symptoms in offspring of parents with bipolar~     disorder (BD). The study will also examine the level of expressed emotion among families and~     how this impacts on FFT treatment outcomes. This study seeks to replicate a previous study~     by Miklowitz, Schneck, Singh, Taylor, George and colleagues (2013), which demonstrated the~     efficacy of FFT among BD offspring. Importantly, the present study will introduce biological~     measures that predict and reflect improvement in symptoms and expressed emotion. These~     markers reflect stress-related biological systems and include saliva samples to ascertain~     cortisol, interleukin-6 (IL-6) and salivary alpha amylase (sAA).~   "
53614|NCT02355353|"~     The primary objective of this study is to correlate the percentage change in apparent~     diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor~     regression grade (TRG) measured in the surgical resection specimen.~   "
53615|NCT02355340|"~     This research study is evaluating bone mineral density in childhood cancer survivors who~     have a history of bone fracture.~   "
53616|NCT02355327|"~     This feasibility trial aims at assessing practical issues and feasibility of a future~     randomised controlled trial (RCT) to determine the effectiveness of vibrating vaginal pelvic~     floor training balls for postpartum pelvic floor muscle rehabilitation, at monitoring harms~     of the experimental intervention, and at exploring women´s perspectives on and experiences~     with the interventions and the trial.~   "
53617|NCT02355314|"~     Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains~     associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria~     (oliguria and serum creatinine elevation), which carry several important limitations.~     Additionally, the investigators lack biomarker that may predict short term renal prognosis.~      Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive~     investigative tool that may hold promise for early AKI detection in ICU patients or in~     differentiating transient from persistent AKI in selected critically ill patients. Although~     several studies have suggested adequate performance in predicting short-term reversibility~     of AKI, most of these studies were performed in limited patient samples. Additionally, a~     recent study has identified discrepant results regarding its diagnostic performance.~      The main objective of this large prospective multicentre study is to assess diagnostic~     performance of Doppler-based renal resistive index in diagnosing persistent AKI in~     critically ill patients requiring mechanical ventilation.~   "
53618|NCT02355301|"~     The main objective of the investigators is to improve the quality of care in patients with~     orthopedic disorders followed in St Luc hospital (Brussels Belgium). To do this, the~     investigators want to assess the impact of Orthopedic treatments at the structural level~     (bone structure, muscle, etc.), at the functional level (mobility, strength, stiffness...),~     on the restriction of activities of patients (walking, make its care daily..) and on the~     limitation of participation in the life of every day (sport, work, social life,~     cultural...). This functional evaluation of patients with orthopedic disorders by the ICF~     model is an original approach rarely used in muscular-skeletal impairments that can very~     improve the management of these patients and their quality of life. In addition, the~     investigators associate the harvesting of all medical and computer data collected by~     high-precision tools in the surgical treatments, to better define the surgical precision and~     improve the quality of surgical care.~   "
53619|NCT02355288|"~     The purpose of this study is to evaluate whether less invasive bypass surgery using the left~     chest wall artery is more or less effective than inserting a heart stent in patients with~     diabetes and a blockage of the main artery at the front of the heart. This will be a~     clinical trial study where the investigators will test the rate of recruitment into the~     study, as well as the feasibility of allocating each of the 2 treatments.~   "
53620|NCT02355275|"~     The purpose of this study is to determine the effectiveness of a Thera-Band based home~     exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.~   "
55728|NCT02327702|"~     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive~     pregnant chronic hepatitis B patients. Single group patients were enrolled to receive~     emtricitabine till 48 weeks after delivery.~   "
53621|NCT02355262|"~     This randomized research trial studies the Community-based Health Information Technology~     (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in~     increasing cancer screening and prevention care in uninsured patients at community health~     centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage,~     leading to improved cancer screening and prevention rates in community health care settings,~     and general recommended preventive care.~   "
53622|NCT02355249|"~     This study is a multi-center, randomized, and open-label trial to compare the safety and~     feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic~     esophagectomy for esophageal cancer.~   "
53623|NCT02355236|"~     Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID)~     and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce~     risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in~     the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The~     purpose of this study is to investigate whether naxozol protects the gastrointestinal tract~     effectively compared to celecoxib, a COX-2 inhibitor.~   "
53624|NCT02355223|"~     The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis~     (TB) infection control known as FAST (Find cases Actively based on cough surveillance,~     Separate temporarily, and Treat effectively). It is anticipated that this will decrease time~     to effective treatment initiation and also decrease transmission of TB to health care~     workers.~   "
53625|NCT02355210|"~     This study evaluates the effect of a dietary supplement to improve gut health. The~     participants will take one of six dietary treatments for three weeks, and the gut bacteria~     and the gut intestinal barrier will be assessed to determine if these dietary treatments~     beneficially change these markers of gut health.~   "
53626|NCT02355197|"~     Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32~     weeks and high blood sugar levels were found so Cases were controlled by both diet and~     insulin.~      The 200 pregnant women with Gestational diabetes mellitus were randomized using automated~     web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid~     (vitamin C )per day from the time of diagnosis until the time of delivery in addition to~     routine treatment of diabetes (diet & insulin). Group2 received only the treatment of~     diabetes~   "
53627|NCT02355184|"~     This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term~     efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral~     suppression in patients who were stable on combination antiretroviral therapy and completed~     12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing~     virologic failure.~      Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks.~     Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of~     existing retroviral regimen and PRO 140 at the end of the treatment extension phase in~     subjects who do not experience virologic failure.~   "
53628|NCT02355171|"~     The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer~     patients willingly consent to provide residual, clinical samples (surplus after diagnostic~     testing) of their tumors for cancer research, to give access to their medical record for~     data collection and then followed prospectively throughout the trajectory of their illness.~     They further willingly consent to be recontacted for being informed of other research~     projects, including clinical trials.~   "
53629|NCT02355158|"~     Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of~     Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed~     their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into~     this study and receive active study drug in an open-label manner.~   "
53630|NCT02355145|"~     A non-interventional, multicentre study to observe the main criteria used in clinical~     practice by physicians when selecting the second-line add-on therapy in patients with~     inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data~     will be collected by reviewing the medical records of patients with type 2 diabetes and~     add-on therapies at the time of presenting to endocrinologist according to clinical~     practice. The patients will participate in only one study visit, at the time of enrolment.~     Two study groups are to be defined at two time-points.~   "
53631|NCT02355132|"~     This study examines the impact of a randomized insurance experiment on preventive services~     receipt and healthcare utilization in safety net patients using linked public insurance~     claims and safety net clinics' electronic health record (EHR) data.~   "
53632|NCT02355119|"~     Patients with resected pancreatic cancer who fulfill the selection criteria will be~     randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine,~     the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin~     and Irinotecan), the experimental arm.~      A total of 310 patients will be enrolled in about 50 Italian centers.~   "
53633|NCT02355106|"~     The objective of the study is to demonstrate the safety and feasibility of the Adagio System~     in subjects with Atrial Flutter.~   "
53634|NCT02355093|"~     This study aims to compare continuous femoral nerve block with adductor canal block after~     anterior cruciate ligament reconstruction arthroscopically，especially in the effect on~     quadriceps strength; and to evaluate which regional anesthesia is more ideal for the~     patients postoperatively.~   "
53635|NCT02355080|"~     This is a randomized controlled clinical trial in which adults receiving drug abuse~     treatment will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The~     purpose of this study is to test the efficacy of two HIV/HCV testing strategies on~     increasing receipt of test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint~     offer of HIV and HCV at the point of encounter), and (2) standard of care for HIV and HCV~     testing.~   "
53636|NCT02355067|"~     This study is intended to compare the acceptability and feasibility and explore outcomes~     related to two different formats of a parenting program for mothers with postpartum~     depressive symptoms. One version will be a traditional, in-person group format, while the~     other will be a social media group format. The investigators will also explore the~     differences in outcomes of both formats, looking at depressive symptoms, parenting sense of~     competency, and parenting interactions with children.~   "
53637|NCT02355054|"~     The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11~     choline for evaluation of men with biochemically recurrent prostate cancer while awaiting~     approval of the Washington University Abbreviated New Drug Application for C-11 choline.~   "
53638|NCT02355041|"~     Adolescent obesity is associated with a number of serious health conditions and most obese~     adolescents become obese adults. Despite this fact, very few adolescent health centers offer~     clinical weight loss programs. This is likely because most weight loss programs require~     extensive resources and are not covered by most health insurance policies. However, this is~     expected to change since the American Medical Association's recent decision to recognize~     obesity as a disease. Therefore, it is important to identify simple and effective~     nonsurgical programs for weight loss, which can be used in adolescent health centers. The~     investigators are proposing to show that a meal replacement based diet program will be~     effective in reducing body mass index (weight adjusted for height). In this pilot study, 90~     adolescents will either participate in a meal replacement based weight loss program or watch~     an educational video. Body mass index and body fat will be recorded over time to see if~     adolescents participating in the meal replacement program lose more weight than those who do~     not participate in this program.~      In order to address this objective, the investigators will assess group differences in body~     mass index (BMI; kg/m2), body composition (% body fat), eating disorder symptoms and~     psychological/behavioral variables.~   "
53639|NCT02355028|"~     The purpose of this study is to evaluate the efficacy of 84 successive days of topically~     administered LHA510 compared to vehicle in reducing the number of patients requiring~     intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for~     recurrence of active choroidal neovascularization (CNV).~   "
53640|NCT02355015|"~     The study aims to address the following aims~        1. To provide an overview of the epidemiology of the patients who are managed in the~          Singapore General Hospital for NTM infections.~        2. To evaluate the medical care of patients in the institution with regards to the type of~          medical and/or surgical treatment received and specifically, the antibiotic regime and~          duration administered.~        3. A longitudinal follow up which will allow an assessment of our care and patient outcome~          in this population cohort~   "
53641|NCT02355002|"~     The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic~     stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive~     compulsive disorder. Additionally, this study aims to identify the mechanisms of action of~     TMS and potential biomarkers and predictors of treatment response.~   "
53642|NCT02354989|"~     The purpose of this study is to evaluate the effect on distance covered in a 6 minute~     walking test of Rate Responsive pacing in patients with permanent atrial fibrillation and~     reduced left ventricular ejection fraction treated with atrioventricular junction ablation~     and biventricular pacing.~   "
53643|NCT02354976|"~     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study~     performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and~     fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with~     over-weight and hypertriglyceridemia.~   "
53644|NCT02354963|"~     This study aims to assess whether activation of primordial follicles through ovarian cortex~     fragmentation may increase the number of antral follicles present in the ovary of patients~     with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and~     pregnancy rates after IVF.~      Hypothesis; Evaluate whether the proposed intervention increases the pool of antral~     follicles (potentially stimulable ones).~   "
53645|NCT02354950|"~     This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in~     adults with moderate and mild (if needed) hepatic impairment and matched, healthy control~     subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to~     subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean~     total plasma area under the concentration-time curve from time zero (pre-dose) extrapolated~     to infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately~     impaired subjects relative to matched controls, Part 2 will be conducted to evaluate~     GSK1265744 PK in subjects with mild hepatic impairment (n=8) and matched, control subjects~     (n=8). All subjects will receive a single 30 milligram (mg) oral dose of GSK1265744. The~     primary objective of the study is to compare plasma PK parameters of GSK1265744 in subjects~     with hepatic impairment to healthy controls matched in gender, age, and body mass index~     (BMI).~   "
53646|NCT02354937|"~     GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development~     for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal~     elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine~     after a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance~     on overall 744 elimination, renal impairment may potentially inhibit some pathways of~     hepatic and gut drug metabolism and transport, and as a result may impact 744~     pharmacokinetics. The current Food and Drug Administration (FDA) draft guidance for renal~     impairment studies suggests that a pharmacokinetic (PK) study in patients with renal~     impairment be conducted even for those drugs primarily metabolized or secreted in bile.~      The study will be comprised of two cohorts (severe renal impairment and normal renal~     function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study~     center and undergo serial PK sampling following a single dose of oral 744 30 milligrams~     (mg). Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744~     30 mg dose.~   "
53647|NCT02354924|"~     The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens~     could be prescribed as a supportive care for myopic persons.~   "
53648|NCT02354911|"~     The purpose of this study is to determine whether dendritic cells collected via~     leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into~     the same subject will serve as modulators of the immune system in a manner that disrupts the~     autoimmune process responsible for the destruction of pancreatic beta cells in subjects with~     new onset type 1 diabetes.~   "
53649|NCT02354898|"~     This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or~     BBI503 in combination with Sorafenib. This study population is adult patients with advanced~     solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in~     combination therapy.~   "
53650|NCT02354885|"~     Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic~     acid (TXA) seems to improve survival and outcome. Thus this study evaluates the~     administration of TXA on scene by the emergency medical services (EMS) or by the crew of a~     rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI).~     Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.~   "
53651|NCT02354872|"~     The ultimate goal of this research is to develop a chronic care treatment package for~     smokers that will address the challenges and opportunities of each phase of the cessation~     process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to~     develop treatments for smokers not yet ready to quit, those who are preparing to quit, those~     actively engaged in the quitting process and those who have tried to quit but relapsed. To~     achieve this goal, this research comprises three distinct research studies, each of which~     represent a phase in a comprehensive chronic care treatment model for clinical intervention~     with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the~     Long-term Quitting Study. The goal of each study is to test and identify effective~     intervention components for distinct phases of the smoking cessation process. These~     components will then be combined for future research on the effectiveness of this chronic~     care treatment package. This study is a 2x2x2x2 factorial design. Participants will be~     randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No~     Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral~     Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs~     Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No~     Behavioral Activation Counseling. These components have strong theoretical and empirical~     support, but their relative, additive, and interactive effects are unknown.~   "
53652|NCT02354859|"~     The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary~     function as measured by a 5% or greater relative improvement in forced expiratory volume in~     one second (FEV1) from baseline to Day 28.~      Funding Source - FDA OOPD~   "
53653|NCT02354846|"~     An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy~     with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving~     Rituximab-CHOP Chemotherapy (SPEED study)~   "
53654|NCT02354833|"~     The purpose of the study is to determine if a medication called phenylephrine, which helps~     to control blood pressure, is more effective as a continuous intravenous (IV) infusion~     compared to continuous IV norepinephrine in maintaining blood pressure during a spinal~     anesthetic for a cesarean delivery. Good blood pressure control has been shown to decrease~     nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective~     cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic~     and morphine (provides long term pain control after cesarean delivery). This study plans to~     enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned~     according to a computer generated system to be in one of two groups.~   "
53655|NCT02354820|"~     This project seeks to expand an existing computerized decision support system used in~     pediatric primary care. The expanded system will add a module that helps clinicians~     recognize constipated children and then provides evidence-based reminders for constipation~     management, as well as automates patient educational materials. The current system is~     deployed across multiple sites, and the constipation module will be randomized to deployment~     in different sites. The difference in constipation management and patient outcomes will then~     be compared between sites receiving the intervention and sites not receiving the~     intervention over a 12 month period.~   "
53656|NCT02354807|"~     To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue~     (BAT or Brown Fat) and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3~     agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure~     to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist~     Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism~     in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.~      The investigators anticipate that both methods to stimulate supraclavicular BAT and~     subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake~     on positron emission tomography (PET) images as well as oxidative metabolism. This would~     demonstrate that pharmacological stimulation of BAT is effective and could lead to further,~     more detailed clinical trials in obese subjects.~   "
53657|NCT02354794|"~     The purpose of this study is to determine whether oral supplementation with one form of~     arginine improves vascular endothelial function in healthy subjects with risk factors~     associated with the metabolic syndrome~   "
53658|NCT02354781|"~     The proposed clinical trial is an outgrowth of the safety record and functional improvement~     seen in the BMD follistatin gene therapy trial. In this study the investigators propose to~     inject AAV1.CMV.huFS344 at a total dose of 2.4E12 vg/kg to six DMD patients. This dose will~     be divided between gluteal muscles, quadriceps and tibialis anterior. This is a wider~     distribution of vector than given to BMD patients, who overall improved the distance walked~     on the 6MWT without adverse events related to viral transduction into a single muscle.~   "
53659|NCT02354768|"~     Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30~     days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and~     renal failure. Nowadays, there are no recommendations nor national nor international for~     high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current~     practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit~     to decrease significantly gastrointestinal secretions. Several teams use these analogs in~     order to decrease the flow of highly productive ileostomy.~      The aim of the study is to evaluate the efficacy first line treatment with lanreotide~     associated with current anti-diarrheal treatment for patients with high output ileostomy (or~     greater throughput 2l / 24h) with or without associated dehydration~   "
53660|NCT02354755|"~     The purpose of the current study is to examine whether changes in intraoperative ambient~     temperature has in impact on the clinical performance of the physicians in training which~     include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists~     (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT,~     Ambulatory Monitoring Inc., NY) device.~   "
53661|NCT02354742|"~     Echocardiography (cardiac ultrasound) is being used more often in the critical care setting~     for management of severe infection (septic shock). Early studies show echocardiography to be~     useful in these patients, but at this time, there are no good clinical trials to justify its~     use.~      Our study goals/objectives are as follows:~        1. To conduct an unblinded, two-group randomized controlled clinical trial to compare an~          echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy~          (EGDT) protocol in patients with severe sepsis or septic shock.~        2. Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and~          other non-invasive assessments of cardiac output will result in more rapid resolution~          of septic shock compared to invasive EGDT.~        3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive~          less administration of intravenous fluid.~   "
53662|NCT02354729|"~     Fifteen million Americans suffer from food allergies. Food allergies can be life~     threatening; the only known life-saving treatment is epinephrine. Adolescents/young adults~     are at increased risk of adverse events, because of increased risk-taking with food and~     decreased likelihood of carrying epinephrine. This is a pilot randomized trial to test text~     message reminders, with and without financial incentives, to encourage allergic young adults~     to carry epinephrine.~   "
53663|NCT02354716|"~     The purpose of this study is to investigate the use of a functional luminal imaging probe to~     characterize benign esophageal luminal strictures before and after dilation and identify~     predictors of response to therapy. Patients will be evaluated during endoscopy using~     functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to~     characterize the geometry of benign luminal esophageal narrowing before and after dilation.~   "
53664|NCT02354703|"~     The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice~     daily) administered orally for a period of 16 weeks in reducing risky drinking among~     currently drinking subjects with alcohol use disorder who have selected genotypes at the~     serotonin transporter and receptor genes. The secondary objective is to assess the safety~     and tolerability of ondansetron in subjects with alcohol use disorder who have selected~     genotypes at the serotonin transporter and receptor genes.~   "
53665|NCT02354690|"~     Background:~      Adoptive T cell therapy with tumor infiltrating lymphocytes (TILs) has been reported to~     induce durable clinical responses in patients with metastatic melanoma. From patients own~     tumor material T cells are extracted, expanded and activated in vitro in a 4-6 weeks culture~     period. Before TIL infusion patients are preconditioned with a lymphodepleting~     chemotherapeutic regimen. After TIL infusion, patients are treated with IL-2 to support T~     cell activation and expansion in vivo.~      The BRAF inhibitor is an approved treatment of metastatic melanoma and functions by~     selectively inhibiting the BRAF mutated enzyme, consequently halting the proliferation of~     tumor cells. Furthermore, in vitro tests have shown that vemurafenib has immunomodulatory~     effects that are hypothesized to synergize with TIL therapy, which has been confirmed in~     animal studies.~      Objectives:~        -  To evaluate safety and feasibility when combining vemurafenib and ACT with TILs.~        -  To evaluate treatment related immune responses~        -  To evaluate clinical efficacy~      Design:~        -  Patients will be screened with a physical exam, medical history, blood samples and ECG.~        -  Patients will start vemurafenib 960 mg BID and will continue during TIL preparation.~        -  7 days after start of vemurafenib, patients will undergo surgery to harvest tumor~          material for TIL production.~        -  Patient stops vemurafenib and is admitted day -8 in order to undergo lymphodepleting~          chemotherapy with cyclophosphamide and fludara starting day -7.~        -  On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion~          continually following the decrescendo regimen.~        -  The patients will followed until progression or up to 5 years.~   "
53666|NCT02354677|"~     COPD is characterized by exagerated decline FEV1 related to obstructive non reversible~     airflow. This could be the consequence of structural changes and inflammatory pattern of the~     bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD~     including a decrease in Club cells number and function.There is no treatment actually~     available targeted to a normal repair of the epithelium. The objective of this work is to~     identify potential targets for reprograming bronchial epithelial cells I order to achieve a~     good repair.~   "
53667|NCT02354664|"~     This study intends to evaluate dynamic respiratory motor performance as a valuable measure~     of pulmonary function in adults with late-onset Pompe disease. The investigators will adopt~     a strategy that includes comprehensive evaluations of respiratory volume, flow, and timing~     parameters during resting and loaded breathing. These evaluations will then be associated to~     the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle~     function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic~     descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease~     will be contrasted to the function of age- and gender-matched control subjects. This~     approach will enable the investigators to evaluate the relationship between dynamic~     diaphragmatic function and respiratory motor function.~   "
53668|NCT02354651|"~     The purpose of this study is to determine the effect of diaphragm pacing on respiratory~     function in subjects with Pompe disease by evaluating the duration and pattern of~     spontaneous respiratory function versus paced ventilation respiratory function in patients~     with Pompe disease who have received the NeuDx Diaphragm pacer (DPS).~   "
53669|NCT02354638|"~     In addition to the passengers smoking inside the cab, the taxi drivers,are themselves~     addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the~     cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness~     of the cab drivers with respect to the hazards of tobacco and significance of the smoke free~     legislation.~      It's been six years since the implementation of rules prohibiting smoking in public places~     and a re-look at the compliance to this regulation is necessary. The study will also help~     tobacco users to quit their habits. They will get screened for oral premalignant and~     malignant lesions.~      Also, the cab drivers may pass on some effective messages regarding importance of keeping~     oneself away from tobacco, to the customers while commuting. In view of the above~     background, the current study is proposed to look at all these aspects.~      The findings of the study will be certainly generating useful information with regards to~     lacunae in the existing system for appropriate implementation and for strengthening anti~     tobacco advocacy in our country.~   "
53670|NCT02354625|"~     The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)~     transplantation in participants with chronic SCI.~      This trial design is phase I, open label, unblinded, non-randomized, and non-placebo~     controlled multiple injury cohorts.~   "
53671|NCT02354612|"~     This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have~     completed a previous TRC105 study and are judged by the investigator to have the potential~     to benefit from continued TRC105 therapy.~   "
53672|NCT02354599|"~     The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of~     single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male~     participants.~   "
53673|NCT02354586|"~     This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of~     niraparib in ovarian cancer patients who have received three or four previous chemotherapy~     regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once~     daily continuously during a 28-day cycle. Health-related quality of life will be measured by~     Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will~     be assessed by clinical review of adverse events (AEs), physical examinations,~     electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.~   "
53674|NCT02354573|"~     What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes~     with each heartbeat. In some people with heart failure, the heart contracts normally but~     there is reduced relaxation of the heart. As a result, people notice a feeling of~     breathlessness, ankle swelling and fatigue especially on exertion.~      The investigators feel that patients with reduced or impaired relaxation of the heart have~     less heart filling time and poor energy utilisation during exercise. Therefore, the~     investigators are conducting a study to more thoroughly understand the disease condition by~     giving a drug called ivabradine to reduce the heart rate and hence to increase the heart~     filling time in these patients.~   "
53675|NCT02354560|"~     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world~     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly~     affects the risk. Around one third of all genetic disorders as well as most cases of~     Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur~     as a result of premature nonsense mutations (creating a stop codon) in an individual's~     adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in~     the DNA that prematurely halt the protein translation process, producing a shortened,~     nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the~     premature stop codon signal, the resulting protein may be able to ameliorate or stop the~     disease.~      Recently, members of the aminoglycoside family of antibiotics have been found to induce~     ribosomal read-through of nonsense mutations, leading to expression of a full length,~     functional protein. Investigators have recently shown that members of the aminoglycoside and~     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC~     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.~      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin~     to induce read-through of the nonsense mutations in the APC gene and to induce expression of~     a full length, functional APC protein in patients suffering from FAP and to tests its effect~     on adenoma number and size and on desmoid tumors in these patients. The future goal is to~     maximize the effect of stop-codon suppressors on APC while minimizing side effects.~      In this study investigators will select FAP patients which carry APC nonsense mutations,~     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as~     well as abdominal desmoid tumors, that will be documented before during and after treatment.~     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as~     blood samples from these patients for changes in expression levels of the APC protein and~     related oncogenic markers.~      Suppression of nonsense mutations within the APC gene should be of benefit for patients~     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or~     diffuse CRC. Furthermore, given the rapid progress being made in the identification of~     different nonsense mutations in human genes that lead to mostly un-curable disease, the~     identification of clinically approved compounds that suppress nonsense mutations and that~     can be administered long-term without significant side effects would open new venues in the~     treatment of genetic human diseases that arise from pre-mature stop codons in important~     coding sequences.~      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation~     in FAP patients. The read-through effect of erythromycin will be clinically tested by~     counting and measuring the number and size of both colonic and duodenal adenomas before and~     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas~     and desmoid tumors will be tested by western blot, immunofluorescence and~     immunohistochemistry for restoration of APC expression and changes in oncogenic markers.~     These experiments should be conducted within 6 month.~      Long term objective:~        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia~          and CRC in patients expressing a truncated APC protein due to nonsense mutations.~        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC~          nonsense mutation suppression using in-vitro methods. Investigators will focus on~          macrolide antibiotics that are currently in clinical use and are administrated for long~          terms. These objectives should take around 6 month and will be conducted in parallel.~   "
53676|NCT02354547|"~     The purpose of this study is to determine the dose limiting toxicities and recommended phase~     2 dose of SGT-53 alone and in combination with topotecan and cyclophosphamide in pediatric~     patients with recurrent or refractory solid tumors.~   "
53677|NCT02354534|"~     This phase I research protocol is designed to assess immunogenicity and clinical endpoints~     in patients with HPV16 CIN2/3. The protocol tests the use of artesunate in suppository~     formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).~      The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility~     of intravaginal administration of artesunate in health women with CIN2/3.~   "
53678|NCT02354521|"~     An observational, point-prevalence cohort study of nutrition therapies in critically ill~     children in PICUs across the world. Baseline information will be collected including PICU~     and hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score,~     weight, height) of critically ill children requiring mechanical ventilation in the PICU.~     Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed~     and received, interruptions, etc., will be collected on a daily basis from PICU admission~     onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical~     ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days~     after admission to the PICU. The main objective of the study is to examine the association~     between energy and protein intake adequacy (in relation to the prescribed goals for these~     nutrients) and 60-day mortality in mechanically ventilated children.~   "
53679|NCT02354508|"~     This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and~     safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled~     acromegaly with maximal approved doses of first generation somatostatin analogues. The study~     will enroll inadequately controlled patients by high doses (maximal approved) of~     first-generation somatostatin analogues given for at least 3 months. Patients will receive~     pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have~     completed all visits of core phase and have completed all the assessments at the core phase~     completion visit can move into the 32-week extension phase. Patients can continue with study~     treatment until pasireotide LAR is commercially available and reimbursed in their respective~     country or until the end of the extension phase whichever occurs first.~   "
53680|NCT02354495|"~     The investigators aim to examine the feasibility of individualized diet intervention in~     children dependent on long-term mechanical ventilator support at home. The investigators~     will use a multidisciplinary model that will allow for diet modification based on~     comprehensive nutrition, metabolic and respiratory assessments performed in the subjects'~     home. the impact of this intervention (for 12 weeks) on body composition and respiratory~     variables will be assessed.~   "
53681|NCT02354482|"~     Funded by the Patient Centered Outcome Research Institute (PCORI), nationally recognized~     leaders in health care and research methods are partnering with patients and caregivers to~     evaluate the effectiveness of current efforts at improving care transitions and develop~     recommendations on best practices for patient-centered care transitions and guidance for~     spreading them across the U.S.~   "
53682|NCT02354469|"~     Recently, researchers and clinicians have examined many different forms of concussion~     testing aimed to assess if a brain injury has occurred and to what degree it affects the~     individual being tested. Due to the multifaceted and complex presentation of concussive~     injuries and the unknown effects of repeated head trauma, it is unlikely that a single test~     of physiological or behavioral function will reflect the full range of injury-related~     damages from a concussive event or from a series of cumulative head traumas, as well as the~     injury response within brain tissue. However, by combining a variety of objective~     assessments which may detect structural and functional alterations following head trauma~     into a single study, a clearer understanding of the multi-faceted presentation resulting~     from head trauma may be identified. The identification of biomarkers and the utilization of~     objective and clinically feasible tools will provide a method to assess three domains across~     multiple systems affected by head trauma: 1) the prognostic value of initial concussion~     assessments to identify injury severity and factors responsible for prolonged recovery, 2)~     the temporal window of recovery and potential vulnerability of brain tissue post-injury, and~     3) the long-term alterations associated with repeated head trauma exposure.~   "
85654|NCT01936454|"~     A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the~     3rd and 4th years of use in Chinese women~   "
53683|NCT02354456|"~     Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and~     associated with increased cardiovascular morbidity and mortality. Our previous AFTER study~     demonstrated the general epidemiological data about the patients with valvular and~     nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants~     (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management~     modality in our country. In this multicenter trial the investigators aimed to analyze,~     follow and evaluate the epidemiological data in non-valvular AF patients.~   "
53684|NCT02354443|"~     The purpose of this study is to describe the safety profile of ProHema-CB as part of a~     single cord blood unit transplant after a myeloablative conditioning regimen in pediatric~     patients with inherited metabolic disorders. The safety profile will primarily be assessed~     by neutrophil engraftment.~   "
53685|NCT02354430|"~     To investigate the possible effect of an unsupervised water-exercise program, on the~     intensity of low back pain and the number of days spent on sick leave, among healthy~     pregnant women Our hypothesis is, that 45 minutes of water exercise twice a week for a~     period of 12 weeks during pregnancy, will reduce the intensity of low back pain and the days~     spent on sick leave.~   "
53686|NCT02354417|"~     This is an open-label, safety study of a single ProHema-CB product administered following~     myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.~   "
53687|NCT02354404|"~     Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety,~     tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and~     VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with~     the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2.~      Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1~     will include at least 60 volunteers who have never received an investigational Ebola~     vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include~     up to 30 eligible participants who previously participated in the RV 247 vaccine clinical~     trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine.~      Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine~     at the same dose level.~   "
53688|NCT02354391|"~     The objective of this study is to determine the efficacy, safety, and patient satisfaction~     of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy~     (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical~     treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test~     group and the control group. Each patient will have four distinct treatment areas of 25cm2~     on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato®~     0.015% gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a~     control and will receive none of the treatments.~   "
53689|NCT02354378|"~     The goal of this study is to determine the effects of dexmedetomidine on memory and recall~     of children who are receiving dexmedetomidine sedation administered for magnetic resonance~     imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for~     diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at~     Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in~     children has not been studied.~   "
53690|NCT02354365|"~     Typically doctors adjust the settings on the ventilator to ensure that children receive~     enough help to decrease the work they perform to breathe, receive enough oxygen through the~     machine to pass into the blood and to the organs, and remove acid that builds up in the~     blood. However, sometimes the settings we choose can result in damage to the lungs. We are~     trying to find a better way to determine the best ventilator settings, which can minimize~     potential damage to the lungs, and still provide children with enough support to decrease~     the work they have to do to breathe. We believe we can personalize these choices for each~     child by looking at the pressure that is generated in the chest while children breathe with~     the ventilator. This is accomplished by using a small tube which goes through the nose and~     into the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor~     pressure. This same tube can then also be used to monitor how much work children need to do~     to breathe as we are turning down the ventilator in preparation to remove the breathing~     tube.~   "
53691|NCT02354352|"~     The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving~     cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with~     Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be~     enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will~     use a drug diary to record daily compliance of taking the study medication as well as any~     concerns they may have during the study period. Subjects will undergo cardiac magnetic~     resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12~     months post enrollment. Subjects will also complete a quality of life questionnaire at~     baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at~     baseline and 12 months.~   "
53692|NCT02354339|"~     The metabolic syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers from the disease and predispose the onset of diseases like cardiovascular~     disease and diabetes mellitus type 2.~      The first line of treatment for metabolic syndrome is diet and exercise but patients have a~     low attachment to the treatment, so pharmacologic therapy is required. There is no a single~     drug that could help to the treatment of all metabolic syndrome components.~      Irvingia gabonensis, better known as African mango, is widely consumed in central and~     western Africa, mainly the fruit and seeds. Besides being part of the diet of African the~     seeds have been used for the treatment of diseases such as dysentery, diabetes and as an~     analgesic.~      Resent investigations have demonstrated that an extract of African mango seeds induce~     significantly weight loss in subjects with obesity, and also improves some biochemical~     parameters such as glucose and the lipid profile.~      The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic~     syndrome, insulin secretion and insulin sensitivity.~   "
53693|NCT02354326|"~     This clinical trial studies dual energy computed tomography (CT) in finding cancer that has~     spread from the original (primary) tumor to the bone (bone metastases) in patients with~     cancer. Diagnostic procedures, such as dual energy CT, may help find and diagnose bone~     metastases and may be more accurate compared to single energy CT alone.~   "
53694|NCT02354313|"~     A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus~     observation after intensified induction regimen containing rituximab followed by high dose~     chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult~     patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).~   "
53695|NCT02354300|"~     Flow diverters have been approved since 2012 for the treatment of large, wide neck~     intracranial aneurysms. These devices have been associated with embolic events which cause~     blockage in a blood vessel and can result in long term complications. One possible cause of~     these events is the formation of small emboli during placement of the device.~   "
53696|NCT02354287|"~     There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal~     polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the~     American Society of Gastrointestinal Endoscopy have guidelines for the removal of these~     polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy~     are diminutive to small.~      Multiple techniques are used for polyp removal, especially diminutive lesions. These include~     either forceps, both hot and cold, as well as snare with electrocautery or cold snare.~     Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a~     current through the grasper to essentially burn tissue. Snare is the use of a small metal~     loop placed and tightened at the base of polyps to cut through the tissue either straight~     away in a cold method or with electrocautery where a small current is passed through the~     loop to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in~     Australia and the United States show that the choice of method used for diminutive to small~     polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy~     techniques are limited and it is clear that additional data and the review of polypectomy~     methods needs to be undertaken in order determine the optimal method for the removal of~     diminutive and small colorectal polyps.~      A technique is used at the Gloucestershire National Health Service (NHS) trust involving a~     submucosal pre injection with a standard solution then the use of cold forceps for removal~     of polyps ≤7mm. This appears to be both very safe and highly effective method for the~     removal of these lesions compared to other techniques. No formal published studies have been~     completed to evaluate this method at national and international levels. We propose a study~     to evaluate the effectiveness, safety and costs of this method.~   "
53697|NCT02354274|"~     To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on~     an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a~     standard homogeneous dose spread~   "
53698|NCT02354261|"~     The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell~     Carcinoma Nevus Syndrome.~   "
53699|NCT02354248|"~     TST (Triple stimulation technique) helps to better quantify the proportion of motor units~     activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is~     proportional to the intensity of conduction disorders. The evaluation of these disorders is~     more precise with this technique than with the slowing of the central conduction time (CCT).~      The investigators propose to use this technique in CNS pathologies where this disorder is~     significant and essential, like multiple sclerosis and stroke.~   "
53700|NCT02354235|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and~     have inadequate glycemic control.~   "
53701|NCT02354222|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and~     have inadequate glycemic control.~   "
53702|NCT02354209|"~     The purpose of the study is to look at possible reasons why some HIV positive people who~     take their drugs properly and have no resistance to these drugs, still have low amounts of~     virus detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels~     of HIV virus are present, some can mutate and make the drugs less effective (i.e. some~     variants of the virus become more resistant). Currently, however, these resistance mutations~     may be difficult to detect using standard tests for resistance because the amount of virus~     in the blood is very low and the standard tests aren't sensitive enough to pick up the~     mutations. The investigators will use more sensitive mutation detection methods, known as~     Next Generation Sequencing (NGS), to look at whether see if there are any low levels of drug~     resistant HIV virus developing in the blood when LLV occurs. The investigators will look at~     the different treatment strategies that are used in routine standard practice when LLV is~     detected and evaluate which is most effective in preventing development of resistance. The~     investigators hope this research will help to inform guidelines on the best way to treat HIV~     in the future.~   "
53703|NCT02354196|"~     To determine the total plaque burden, plaque severity and composition of patients undergoing~     Cardiac CT who do not have any previous history of CVD. There are two cohorts:~        1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA >1 year~          ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2.~        2. A prospective observational registry of patients referred to undergo CCTA with a 1 and~          2 year follow-up.~   "
53704|NCT02354183|"~     Research suggests that individuals with Borderline Personality Disorder (BPD) experience low~     motivation for change (Skodal, Buckley, & Charles, 1983). Dialectical Behavior Therapy (DBT;~     Linehan, 1993) includes commitment strategies that are designed to improve motivation. No~     studies have examined the effectiveness of these strategies. The proposed study will~     evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus~     skills training for people who self-harm. Participants will be randomly assigned to either a~     single orientation session of (1) commitment strategies plus psychoeducation or (2)~     psychoeducation. Immediately following their orientation session, all participants will be~     enrolled in a 90 minute group skills training session. Primary outcomes include autonomous~     motivation and frequency of self harm behaviours. Assessments will be conducted at six time~     points: baseline, after the initial orientation session, after the skills training group~     session, and at one week, one month, and three month follow-up~   "
53705|NCT02354170|"~     The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg~     once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.~   "
53706|NCT02354157|"~     Control rules are common parental practices that use food as reward to encourage children to~     conduct parents' preferred behaviors. This field observational study aims to examine whether~     control rules are associated with children's increased fat, carbohydrate and total energy~     intake in everyday eating, and whether this effect is moderated by individual differences in~     sensitivity to reward, and by gender differences.~   "
55729|NCT02327689|"~     This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV~     related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related~     cirrhosis patients and decompensated HBV related cirrhosis patients.~   "
53707|NCT02354144|"~     The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed~     to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for~     preventing HPV acquisition. Individuals at high risk for infection (men who have sex with~     men, or MSM, and especially those with HIV) will be included in the trial. Participants will~     complete a self-administered baseline questionnaire during the enrolment visit, and~     follow-up questionnaires during all other six visits. The shorter follow-up questionnaires~     are intended to evaluate recent sexual behaviours and to corroborate the responses given~     during the baseline visit. These questionnaires will measure HPV risk factors, compliance,~     and monitor safety and tolerability of the gels. Between follow-up visits, participants will~     be asked to log into a secure web module at least once a week to answer questions on daily~     sexual activities, condom and study gel use, and adverse evens. Individuals will be screened~     for eligibility over the telephone or in person and eligible men will attend an enrolment~     visit, where the nurse will obtain informed consent and instruct the participant on gel use.~     They will receive a one month's supply of gel and provide the first specimen. Random number~     sets will be assigned to the treatment and control gel. Each participant will be assigned an~     individual code, which will be used to match him to the study arm. Lastly, the nurse will~     provide details about HPV infection and advice about condom use and sexual health. HPV~     infection status will be measured using anal specimens at baseline (enrolment/time 0), and~     at all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).~   "
53708|NCT02354131|"~     Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2~     (Randomized Phase 2): to compare Progression-Free Survival (PFS)~      PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer;~     the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well~     as in gBRCAwt, HRD population.~      In the same population there is level one evidence that bevacizumab is beneficial. And a~     phase two randomized study has indicated that combination of a PARP inhibitor with~     anti-angiogenic drug is superior to PARP inhibitor alone.~      The questions are:~      Is single agent PARP inhibitor, niraparib superior to bevacizumab? Is niraparib combined~     with bevacizumab superior to bevacizumab? Is niraparib-bevacizumab combination superior to~     sequential bevacizumab followed by niraparib? The comparison of tolerability and efficacy of~     niraparib-bevacizumab combination against sequential bevacizumab and niraparib.~   "
53709|NCT02354118|"~     The purpose of this study is to determine the safest and most effective flushing solution~     for maintaining patency (unobstructed flow) in implanted port catheters. The complication~     rate in patients whose ports are flushed with saline only will be compared to the~     complication rate in patients whose ports are flushed with a combination of saline and~     heparinized saline.~   "
53710|NCT02354105|"~     The primary purpose is to assess the effectiveness of certolizumab pegol in patients with~     axial spondyloarthritis under routine clinical practice.~   "
53711|NCT02354092|"~     Cervical dilators are frequently used for preparation prior to second trimester surgical~     abortion. While their use decreases complications associated with surgical abortion, their~     placement is often uncomfortable for the patient. Currently there are no proven methods for~     reducing pain during osmotic dilator placement. The use of numbing medication around the~     cervix (paracervical block) may decrease this placement pain.~   "
53712|NCT02354079|"~     The aim of this study is to identify new targets in cholesterol metabolism thanks to a~     genetically-based strategy.~   "
53713|NCT02354066|"~     Patients often seek advice from their treating doctor if they are able to drive with a foot~     orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an~     additional forefoot surgery. This challenging question is of obvious importance for the~     patient and other road users. Previous studies already issued driving ability after~     different orthopedic procedures and with knee and ankle devices on the brake reaction time~     but missed to address the same for foot orthoses after hallux valgus or forefoot surgery.~      This missing evidence made us evaluate the influence of wearing a foot orthosis after a~     first metatarsal osteotomy or forefoot surgery on driving ability (brake response time;~     BRT).~      The overall time frame is about nine weeks; each appointment for BRT measurement takes about~     fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery~     without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days~     (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a~     FRS and eight weeks postoperative without a foot orthoses (6).~   "
53714|NCT02354053|"~     Modern antiretroviral therapeutic regimens offer a vast array of choice that permits~     tailored therapy for HIV patients. While modern regimens have improved the rates of~     virologic suppression overall and reduced adverse effects of antiretroviral treatment, an~     important sub-group of HIV infected persons is unable to maintain adherence to their~     treatment regimens, fail to achieve long term virologic control and remain at risk for HIV~     related disease progression and transmission of HIV infection.~      Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with~     adherence support will improve the rate of HIV suppression in vulnerable populations~     non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50~     copies/mL at Week 24 post randomization.~   "
53715|NCT02354040|"~     Although most patients admitted with acute coronary syndrome or acute ischemic stroke in~     South Asian countries receive these evidence-based treatments, their overall continuation in~     the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in~     this respect because the overall literacy rates remain one of the lowest in Pakistan among~     South Asian Countries. In addition, a great majority of Pakistani patients often do not~     understand or follow health prescriptions (which are still written in English).~     Additionally, due to an unregulated health industry, they frequently take multiple opinions~     and prescriptions from different physicians. The investigators propose to develop a talking~     prescription for patients with stroke or myocardial infarction for secondary prevention.~     This will enable them to understand their medications better, improve health literacy and~     adherence. This is an IT enabled health literacy intervention. Physicians will prescribe~     statin and/or antiplatelet to the selected patients and enter the necessary details on an~     Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2~     arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post~     recruitment for behavioral knowledge assessment and adherence assessment.~   "
53717|NCT02354014|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics~     (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline~     (TMC207) in children and adolescents (0 months to less than [<] 18 years of age) diagnosed~     with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in~     combination With a Background Regimen (BR) of MDR-TB Medications.~   "
53718|NCT02354001|"~     The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in~     the treatment of young women with schizophrenia and schizoaffective disorder. Raloxifene is~     a Selective Estrogen Receptor Modulator (SERM),which means that it can affect the central~     nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,~     information processing and concentration), without adversely affecting reproductive~     tissue/organs such as breast, uterus and ovaries. The investigators are conducting a~     double-blind, placebo controlled, three month study comparing the psychotic symptom response~     of women with schizophrenia in both groups. One group will receive standard antipsychotic~     medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic~     medication plus oral placebo.~   "
53719|NCT02353988|"~     Growing studies demonstrated that Androgen Receptor (AR) has an oncogenic role for the~     patients with AR-positive Triple Negative Breast Cancer (TNBC). AR antagonists in therapy,~     such as bicalutamide, completely binds to the AR, increasing AR degradation, thus are~     investigated for the efficacy of the treatment of patients with AR-positive TNBC in the~     study.~   "
53720|NCT02353975|"~     This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted~     or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the~     pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.~   "
53721|NCT02353962|"~     The aim of this study is to evaluate the feasibility and usability of newly developed~     exergames on exploring the hemineglected space of left neglected stroke patients.~     Furthermore to understand the experience of living with visuospatial neglect and to explore~     the users' experiences (patients and clinic staff) with those new exergames.~   "
53722|NCT02353949|"~     The study examines subjects where there might be an indication for Amyloid-PET according to~     the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a~     Flutemetamol-Positron-Emission-Tomography -Scan (PET) on clinical management and disease~     course will be studied over 6 months.~   "
53723|NCT02353936|"~     As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the~     possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. In a~     phase III study LUX-lung 3 in patients with EGFR mutation-positive non-small-cell lung~     cancer, afatinib monotherapy showed longer progression-free disease survival time of 11.1~     months than that (6.9 months) of pemetrexed/cisplatin combination therapy. Based on such the~     results, it is currently recommended as the standard first-line treatment for EGFR~     mutation-positive lung cancer, and clinical studies are also being actively conducted in~     other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty~     (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a~     patient with esophageal cancer had partial response. Taken together, based upon the results~     from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients~     achieved clinical responses of 3 months or longer.~      Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and~     our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation~     EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer~     characterized by well-known EGFR overexpression. In this phase II trial, afatinib shall be~     administered to patients with squamous cell carcinoma of esophagus to evaluate its effects~     and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through~     further studies.~   "
53724|NCT02353923|"~     The purpose of this study is to determine whether supplementation with OcuStem, a~     nutritional supplement, will reduce the progression of mild to moderate diabetic~     retinopathy.~   "
53725|NCT02353910|"~     Prospective studies on the incidence of VTE during severe sepsis and septic shock remain~     absent, hindering efficacy assessments regarding current VTE prevention strategies in septic~     patients. The investigators will prospectively study consecutively enrolled ICU patients~     with severe sepsis and septic shock admitted at three hospitals. All patients will provide~     informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per~     standard of care and according to the patients' primary team, will be recorded for all~     patients. Patients will undergo bilateral lower (and upper, if a central venous catheter~     [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for~     symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The~     investigators will perform multivariate regression analyses to identify predictors of VTE.~   "
53726|NCT02353897|"~     This study aims to look at patient and physician satisfaction of long term Glabellar lines~     (GL) treatment with Dysport in a real life setting. It will also allow better understanding~     of what patients expect from the treatment, and the injection practices used by doctors.~   "
53727|NCT02353884|"~     The purpose of this study is to find the characteristics of mild cognitive impairment (MCI)~     using technology of Multi-Modality MRI , including structural MRI, functional MRI and~     diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp)~     and stable MCI (MCIs) and further construct the predictable classifier from MCI to~     Alzheimer's disease (AD) based on Multi-Modality MRI characteristics of MCI patients.~   "
53728|NCT02353871|"~     The purpose of the protocol is to demonstrate the safety and the efficacy of a single~     treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin~     complex (BTX A HAC; hereafter referred to as BTX A HAC Next Generation (BTX A HAC NG)), used~     for the improvement in the appearance of moderate to severe glabellar lines (the lines~     between the eyebrows).~   "
53729|NCT02353858|"~     The current trial is evaluating the impact of deep regional hyperthermia on the pathological~     complete response rate in locally advanced rectal cancer in the context of preoperative 5FU~     based radiochemotherapy.~   "
53730|NCT02353845|"~     One purpose of this study is to construct the diagnosis system for early Alzheimer's~     disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then~     further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI~     characteristics of aMCI patients.~   "
53731|NCT02353832|"~     The purpose is to determine if use of rectal spacers are effective at improving protection~     of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure~     of acute effects. It is also to determine whether it provides sufficient dosimetric benefits~     to warrant further clinical investigation in future SABR (Stereotactic Ablative Body~     Radiation) related clinical studies.~   "
53732|NCT02353819|"~     Since high risk prostate cancer requires higher radiation, this study is being done to~     determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also~     to determine the feasibility and safety of each treatment fraction by using cone-beam~     Computed Tomography(CT) information and high speed Graphics Processing Unit based~     computation treatment planning systems. We also plan to determine the safety of treatment to~     the prostate. Health-related quality of life will be measured as part of current clinical~     practice.~        -  Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic~          nodal using 90 day acute toxicity endpoint~        -  Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal~          region at each treatment fraction by using cone-beam CT (CBCT) information and high~          speed GPU based computation treatment planning systems~        -  Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy~          total dose) to the prostate~        -  To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS),~          distant metastasis (DM) free survival, and overall survival (OS)~        -  Health-related quality of life (HRQOL) will be measured as part of current clinical~          practice Patients in each dose cohort will all be treated as a single group for dose~          escalation. There will be two levels of dose escalation—to prostate lesions and to~          pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per~          fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences.~          The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per~          fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will~          receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting~          dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will~          receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).~   "
53733|NCT02353806|"~     This is a phase IV prospective trial to collect and analyze information about the maternal~     pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum~     lactation. The study will also evaluate amlodipine concentrations in the infants of~     breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.~   "
53734|NCT02353793|"~     Hypothermia is a common problem in traumatized patients leading to severe complications such~     as impaired coagulation, increased rate of wound infections and overall patient discomfort~     among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket~     device against the currently used cotton wool blanket in terms of effects on the prevention~     and treatment of hypothermia.~   "
53735|NCT02353780|"~     An Agency for Healthcare Research and Quality executive summary indicated that better~     comparative effectiveness trial designs are needed to determine the relative merits of~     existing versus new and expensive biologic drug therapies for rheumatoid arthritis (RA).~     There are now 9 biologic therapies approved for treating RA. Four classes of biologics (TNF~     antagonists, B-cell inhibitors, T-cell co-stimulator blocker, and Interleukin-6 receptor~     blocker) are approved for use in RA patients with moderate or severe disease activity.~     Several critical questions have arisen, such as 1) what therapy should be prescribed after~     failure of methotrexate and/or other oral disease modifying antirheumatic drugs (DMARDs) to~     adequately control disease activity; 2) what is the level of efficacy of the various~     biologic therapies when compared in head-to-head trials; and 3) what are the mechanisms~     associated with failure of methotrexate and/or other oral DMARD therapy and responsiveness~     to biologic therapies. The MAZERATI study will provide the foundation for answering these~     questions and determining the mechanisms associated with these biologic therapies.~   "
53736|NCT02353767|"~     This study aims to estimate the prevalence of bridging liver fibrosis and cirrhosis (METAVIR~     score ≥ F2) according to METAVIR score in HIV infected patients not chronically infected by~     viral hepatitis but exhibiting a metabolic syndrome according to the IDF definition~     (International Diabetes Foundation).~   "
53737|NCT02353754|"~     This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the~     transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in~     subjects undergoing elective Cesarean section (C-section).~   "
53738|NCT02353741|"~     This single-arm phase II study aims to study the efficacy of a possible first line treatment~     that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with~     concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with~     active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this~     new combinational therapy can benefit short-term and long-term survival of the patients with~     advanced NSCLC.~   "
53739|NCT02353728|"~     The study is an open-label phase 2 clinical and translational trial designed to evaluate the~     effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed~     chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat~     subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted~     National Cancer Comprehensive Network [NCCN] clinical guidelines for 24 months. After 24~     months, if continued therapy is needed subjects will be transitioned to commercial supply of~     study drug.~   "
53740|NCT02353715|"~     This is a pilot exercise physiology and quality of life study of subjects receiving standard~     of care therapy for their prostate cancer using FDA-approved drugs per their labeling~     (abiraterone, enzalutamide, or sipuleucel-T). Subjects with progressive, asymptomatic or~     minimally symptomatic mCRPC scheduled to be treated with either enzalutamide or abiraterone~     acetate for ≥3 months or a course of sipuleucel-T will be allocated to one of the treatments~     arms, according to the treatment chosen by the treating physician.~   "
53741|NCT02353702|"~     Upper abdominal surgery is known to induce such pulmonary complications as pneumonia,~     atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to~     these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a~     recognized tool for measuring the diaphragmatic function.The purpose of this study is to~     evaluate the effectiveness of parietal analgesia with continuous infiltration of local~     anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal~     incision. Our main outcome is to measure the diaphragmatic function with the sniff test in~     44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our~     secondary outcomes are the evaluation of the effect of continuous parietal analgesia with~     ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications~     and post operative recovery. This prospective study will determine if the pre peritoneal~     local infiltration of ropivacaine is useful to decrease post operative diaphragmatic~     dysfunction.~   "
53742|NCT02353689|"~     This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN)~     formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed~     patients through the randomized, double blind and placebo-controlled trial.~   "
53743|NCT02353676|"~     Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative~     recovery. Surgical removal of lower third molars is accompanied by postoperative pain that~     is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine~     hydrochloride for the surgical removal of lower third molars with a postoperative 0.5%~     bupivacaine supplementation would result in lesser postoperative pain and a decrease in~     ingestion of oral analgesics to control the pain when compared to a placebo.~   "
53744|NCT02353663|"~     Rheumatic heart disease remains a major challenge in low and middle income countries. Early~     detection of clinically silent valvular lesions by screening echocardiography allows timely~     implementation of secondary antibiotic prevention, and may prevent progression of disease to~     severe valvular damage and heart failure. The objective of the study is to assess the~     prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently,~     the investigators will evaluate progression of disease in children with early stages of~     subclinical rheumatic heart disease.~      The investigators will perform a population-based observational survey for rheumatic heart~     disease using portable echocardiography among schoolchildren aged 5 to 16 years from~     randomly selected public and private schools. Rheumatic heart disease will be documented~     both according to the modified World Health Organization definition and the~     echocardiographic criteria suggested by the World Heart Federation.~   "
53745|NCT02353650|"~     The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a~     naturally low Q10 level will be selected out of a preselected group of 160 screened out of a~     pre-existed database or patients which visited the ENT-consultation. The 40 patients with~     the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To~     evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus~     analysis and auditory evoked responses will be used as outcome measurements.~   "
53746|NCT02353637|"~     The aim of the study is to investigate, in severely obese adolescents, the effects of a high~     protein, restricted carbohydrates utilizing partial meal replacements diet (HPRC-PMR) on~     weight loss, body composition, and bio-chemical markers of lipid metabolism, insulin~     resistance, and inflammation over a 12 months period.~   "
53747|NCT02353624|"~     The aim of this study was to test the physiological response to a 2800 km cycling~     expedition, from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male~     recreational cyclists.~   "
53748|NCT02353611|"~     Bleaching protocol In each session, volunteers received prophylaxis with pumice powder and~     water. Then, gingival tissue was protected using a light-cured resin gum barrier applied~     according to the manufacturer's instructions (Lase Protect - DMC, São Carlos, SP, Brazil).~     Both bleaching agents were prepared by mixing hydrogen peroxide and thickening compounds~     according to the manufacturer's instructions (with 3 peroxide drops for 1 drop of~     thickener). The resultant gels were distributed uniformly on the upper hemiarcade surfaces~     of the teeth. A total of 8 teeth between the first premolars were bleached for each patient.~     In each bleaching session, the bleaching gels were applied twice for 12 minutes each. In~     each application, the surface of the gel was light activated with continuous irradiance for~     12 minutes using LED/laser light with a total power of 1800 mW (Whitening Lase Plus - DMC~     Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions were completed for the~     patients, and the interval between sessions was 7 days~   "
53749|NCT02353598|"~     This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the~     safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72~     participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination~     [MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered~     after the completion of initial double-blind stage.~   "
53750|NCT02353585|"~     The present study will monitor and explore acute neurovascular emergencies in patients~     treated with NOACs compared to those under treatment with VKAs. The primary aims of this~     study are: (1) To investigate characteristics, management and outcome of intracranial~     hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the~     management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.~   "
53751|NCT02353572|"~     This phase I/II trial studies the safety and best dose of melphalan and bortezomib when~     given prior to an autologous stem cell transplant and to see how well they work in treating~     patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Bortezomib may help melphalan work~     better by making cancer cells more sensitive to the drug. Giving chemotherapy before an~     autologous hematopoietic stem cell transplant helps kill any cancer cells that are in the~     body and helps make room in the patient's bone marrow for new blood-forming cells (stem~     cells) to grow. After treatment, stem cells are collected from the patient's blood and~     stored. More chemotherapy is then given to prepare the bone marrow for the stem cell~     transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy. Giving melphalan together with bortezomib~     prior to autologous hematopoietic stem cell transplant may be a better treatment for~     multiple myeloma.~   "
53752|NCT02353559|"~     The purpose of this study is to test the feasibility of an individual psychological and~     physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to~     reduce traumatic stress and physical symptom burden in individuals newly diagnosed with~     acute leukemia.~   "
53753|NCT02353546|"~     Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to~     alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was~     associated with reductions in depressive symptoms and death anxiety and an increase in~     spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale~     randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced~     cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month~     follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes~     included diagnosis of major depression (SCID), death anxiety, attachment security and~     spiritual wellbeing. Multilevel regression was used to compare change over time between~     groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer~     Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.~   "
53754|NCT02353533|"~     Adenomatous lesions of the colon are premalignant lesions which have the potential to~     develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa~     resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift~     the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or~     failed lifting after the injection of saline. This so- called non- lifting sign is a~     predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to-~     resect. A higher proportion of these lesions fail to be resected completely using the EMR~     technique.~      Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in~     order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et~     al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the~     performance of FTRD resection compared to standard EMR resection of difficult- to- resect~     colon adenomas.~      In this study the investigators aim to compare the success of FTRD versus EMR of difficult-~     to- resect adenomatous lesions (≤ 20 mm).~   "
53755|NCT02353520|"~     Initially, a written consent was obtained from each participant. Then they became familiar~     with the procedure. For intrarater reliability, the first rater assessed the strength of~     pinch grip, elbow flexion and shoulder abduction in three different sessions at short~     intervals on same day in same environmental conditions. All the assessments were performed~     on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.~      For inter-rater reliability, Before the beginning of Procedure both the raters were~     familiarized with the motricity index. The motricity index was administered by two different~     raters on the same subjects within 2 days who were blind to each others results and heir~     results were recorded separately.~   "
53756|NCT02353507|"~     The purpose of this prospective, randomized, comparative multi-center study is to compare~     the effective management of two silver-based dressings in managing exudative wounds in first~     and second degree burns.~   "
53757|NCT02353494|"~     This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in~     Timika, Indonesia with a 42 day follow up period.~   "
53758|NCT02353481|"~     The aim of the study is to develop and assess a prognostic model for patient's survival up~     to 1 year after unscheduled acute heart failure hospital admission in England and Wales.~   "
53759|NCT02353468|"~     This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone~     together works in treating patients with multiple myeloma undergoing stem cell transplant.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and~     dexamethasone together may kill more cancer cells.~   "
53760|NCT02353455|"~     Drug metabolism in the liver is subject to large fluctuations (differences between women and~     men, people of different ethnic backgrounds, children and adults). These large differences~     are responsible for very different drug effects and side-effects (and especially liver~     damage caused by drugs) between individuals. Recent scientific findings suggest that blood~     derived cells can be used to model individual effects of drugs on the liver reflect~     inter-individual differences. Since liver damage caused by drugs is a diagnosis of~     exclusion, the aforementioned cells can be used to identify patients that show higher~     sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify~     the causal agent or possible interactions.~   "
53761|NCT02353442|"~     To identify biomechanical and sensibility changes in people with posterior capsule tightness~     in people with and without shoulder pain.~   "
53762|NCT02353429|"~     This is a prospective study evaluating the activity and the safety of toremifene in patients~     with primary or recurrent sporadic DTs.~      Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will~     start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will~     be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale~     (VAS) every 3 months for the first and second year, twice yearly thereafter. Response will~     be evaluated either by RECIST and/or symptomatic relief.~   "
53763|NCT02353416|"~     Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl~     group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine~     and arginine being the main reactive amino acids on proteins. Following this first step, a~     molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of~     Maillard products.~   "
53764|NCT02353403|"~     The study aims to evaluate the glycaemic and insulinaemic response of short-chain~     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.~   "
53765|NCT02353390|"~     This is a randomized controlled open-label trial. During the study, adolescents and young~     adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either~     oral water hydration in addition to standard care or standard of care alone to evaluate the~     effect of water hydration on the primary outcome of presyncope. This study will also~     evaluate the acceptability of pre-vaccination hydration among adolescents and young adults.~   "
53766|NCT02352558|"~     This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to~     patients with relapsed, refractory hematologic malignancies, including multiple myeloma,~     lymphoma, and others.~   "
53767|NCT02352545|"~     Cough is a common symptom of respiratory medicine clinic patients, which has complex~     etiology and wide-ranging. Cough is usually divided into three categories by time: acute~     cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its~     main etiology is postinfectious cough, which is mostly secondary to viral~     infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene~     (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a~     significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in~     vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a~     role of controlling airway inflammation and decrease airway high activity by suppressing the~     biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by~     Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim~     is to research whether FENO can be used as a biomarker to optimized treatment regimen of~     sub-acute cough.~   "
53768|NCT02352532|"~     The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography~     (SWE) in individuals after routine low back injury and begin an initial investigation of~     it's ability to effectively guide physical therapy treatment with dry-needling as a relevant~     treatment intervention.~      Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with~     and without LBP. The investigators will also examine the interaction between tissue change~     and clinical improvement. The investigators hypothesize that individuals with LBP will have~     higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during~     contraction than individuals without LBP.~      Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle~     stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP~     that receive dry-needling will exhibit larger changes than both individuals with LBP that~     receive sham dry-needling and than individuals without LBP that receive dry-needling.~      Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and~     disability in individuals with LBP. The investigators hypothesize that individuals with LBP~     that receive dry-needling will exhibit larger improvements than individuals with LBP that~     receive sham dry-needling.~   "
53769|NCT02352519|"~     In this research study, the investigators are trying to find out which of the two methods of~     injecting local anesthetics (at the site of the belly button cut or by ultrasound guided~     rectus sheath block) will provide better pain relief and less need for pain medication after~     surgery in children undergoing single incision laparoscopic appendectomy.~   "
53770|NCT02352506|"~     Acute kidney injury (AKI) is a common complication in critical care patients. Currently no~     parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor~     (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate~     the time course of MIF concentrations in patients with AKI.~   "
53771|NCT02352493|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH~   "
53772|NCT02352480|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be~     treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving~     just UCC as provided in up to 100 U.S. wound centers~   "
53773|NCT02352467|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which pressure ulcers will be treated using~     Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary~     Care.~   "
53774|NCT02352454|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated~     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)~   "
53775|NCT02352441|"~     Many Service members (SM) experience executive dysfunction associated with mild traumatic~     brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation.~     Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive~     strategy instruction (MSI) to help patients self-regulate their behavior though a goal~     management process - identifying a goal, anticipating performance problems, generating~     possible solutions, self-monitoring performance during the activity, recognizing maladaptive~     task strategies, stopping and then modifying real-time task behavior by choosing an~     alternate strategy. MSI alone often does not result in improved daily functioning because it~     requires conscious cognitive oversight to employ (which is difficult for people with~     executive dysfunction) and it presumes that simply establishing goals propels goal-directed~     action, when for many people, this is not so. Social psychologists report that people who~     set implementation intentions (if-then statements that link specific situational cues with~     specific goal actions) are more likely to perform goal actions than those who only set goal~     intentions. Implementation intentions are believed to be effective because they enable~     people to switch from conscious-effortful reflective action control to automatic, reflexive~     action control associated with selected situational cues. A team of researchers from the~     Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY~     (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention~     to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC~     iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1)~     the practicality of instructional methods used to teach SM with mTBI-sc to perform the~     ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals~     and performance on a task that challenges executive function using a small randomized~     controlled trial. If the results are positive, a larger study would be conducted to~     determine the impact of ACTION sequence training on SM performance on military-relevant~     tasks and goals.~   "
53776|NCT02352428|"~     The overall aim of this population-based screening study is to assess whether the skin~     cancer screening training of family physicians and dermatologists leads to improved~     screening outcomes. The training course aims to increase the accuracy of detecting early~     stages of skin cancer. Screening outcomes of an intervention region (Calgary, Canada) in~     which physicians receive training will be compared with screening outcomes of a control~     region (Edmonton, Canada) where no physician training is administered.~      The investigators will determine whether:~        -  clinical screening outcomes are more favorable in the group of trained physicians~          compared to non trained physicians~        -  there is an increase of knowledge about skin cancer screening among trained physicians,~          compared to non trained physicians~        -  skin cancer screenings are associated with psycho-social harms~        -  population-based screening has an effect on the overall incidence and~          stage-specific-incidence of skin cancer in Alberta~      The investigators are aiming to recruit 100 physicians per region (total of 200 physicians)~     who will screen 40,000 to 80,000 individuals over a period of 20 months.~   "
53777|NCT02352402|"~     In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits~     blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous~     vein graft occlusion as assessed with coronary computed tomography angiography at 1 year~     after coronary artery bypass grafting surgery.~   "
53789|NCT02353234|"~     The consumption of wholemeal cereals has been associated with the reduction of several~     chronic diseases. The mechanisms behind these protective effects may be linked, besides~     dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly,~     hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the~     highest concentration of ferulic acid, principally contained as monomeric form and diferulic~     acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of~     the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary~     excretion of phenolic metabolites in humans fed with two different kind of a commercial~     bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the~     pharmacokinetics of the main phenolic compounds was also evaluated by measuring the~     circulating metabolites in plasma samples.~   "
53778|NCT02352389|"~     The purpose of the proposed study is to gather critical information that may be useful in~     designing effective prevention and treatment strategies for control of seasonal influenza~     and an influenza pandemic. In particular, the critical questions are related to the virus'~     ability to adapt to efficient replication and spread in humans.~      Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza~     infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United~     States. Children with cancer are more likely to have serious influenza and complications~     than those who have no underlying medical problems. They are also more likely to have~     prolonged influenza illnesses and to shed influenza viruses from their noses for long~     periods of time (sometimes for months). Recent studies suggest that influenza viruses may~     also be carried and shed from the gastrointestinal tract. New types of influenza viruses~     emerge frequently through mutations that occur when the viruses replicate. These mutations~     allow the virus to escape from killing by the immune system and are, in large part,~     responsible for seasonal epidemics of influenza that occur in the fall or winter months. It~     is possible that viruses can mutate when they are carried in the respiratory or~     gastrointestinal tracts for long periods, potentially giving rise to viruses that spread~     more easily to other persons, cause more severe disease, lead to new influenza epidemics or~     make the viruses resistant to drugs used to treat influenza.~      Researchers at St. Jude Children's Research Hospital want to learn about how influenza~     viruses mutate in immunocompromised children. They will investigate how long children with~     cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the~     characteristics of any mutations that are found in these viruses.~   "
53779|NCT02352376|"~     This is a prospective, quantitative, randomized, crossover study. Were included in this~     study 10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the~     first day of the postoperative coronary artery bypass graft (CABG). For data collection was~     performed randomization on the block (2: 4), to determine the first technique to be used and~     then a wash-out period of one hour was allowed for the research subject reaches the systemic~     arterial pressure, heart rate, respiratory rate and oxygen saturation baseline. And after,~     for cross-over, the second technique was performed. Non-invasive ventilation was performed~     for 30 minutes each ventilator. All subjects underwent noninvasive ventilation using two~     models of ventilators, they are conventional (designed for invasive ventilation but is also~     used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation).~     Hemodynamic, autonomic and respiratory variables are monitored. We use the hypothesis that~     non-invasive ventilation performed with two fan models can alter autonomic function and that~     there is hemodynamic changes related to autonomic function in different ventilators in~     postoperative coronary artery bypass grafting.~   "
53780|NCT02353364|"~     The study is designed to evaluate the effectiveness of pre-implantation genetic screening~     (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive~     treatment. Half of the patients will have their embryos tested by PGS and 1 or 2~     chromosomally normal embryos with the highest morphological grading transplanted back to the~     uterus. The other half of the participants will not have their embryos tested and 1 or 2~     untested embryos with the highest morphological grading transplanted back to the uterus.~   "
53781|NCT02353351|"~     Prospective, multicenter, case-cohort study.To identify potential risk factors associated~     with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)~   "
53782|NCT02353338|"~     Background: Wrist fractures are a common injury among people aged 55-70. The radius is one~     of the bones making up the wrist joint, and is typically the site of injury in a broken~     wrist. Methods of treating a broken radius include placing the wrist in a cast for 6 weeks~     (conservative management) or receiving surgery. Surgery allows for earlier movement of the~     wrist and return to activity, while being placed in a cast is less invasive than surgery.~      Surgery to fix these fractures has become more common; however there is little agreement~     about who should receive surgery and who should be placed in a cast to heal. The goal of~     this study is to compare outcomes between people aged 55-70 who have broken their wrist and~     had surgery, and those who received a cast.~      Procedures: Participants in this study will be randomly assigned to one of two study groups~     within 1 week of injury at their first clinic visit with the surgeon.~      Patients in Group A (surgical management) will continue with casting for a total of 6 weeks,~     as indicated by the surgeon.~      Patients in Group B (conservative management) will receive surgery, and the attending~     surgeon will determine the best fracture fixation method for the wrist.~      The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after~     the initial injury. At each assessment, the wrist will be examined and participants will be~     asked to fill in some questionnaires about health, pain, wrist function, and satisfaction~     with the wrist. An X-ray will also be performed on the wrist to assess bone healing.~     Information from each visit will be used to determine how participants are doing and to~     compare the 2 study groups.~   "
53783|NCT02353325|"~     Salt is one of the very few regularly purchased food item in all socioeconomic classes~     including poor remote areas with subsistence farming. Therefore, it is a promising vehicle~     for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the~     burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the~     sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as~     ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and~     impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce~     iron-mediated colour change in fortified salt without significantly compromise~     bioavailability. In the present project we aim to investigate the iron bioavailability from~     salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a~     polymer from the eudragit family (EPO).~   "
53784|NCT02353312|"~     To study the hypothesis that treating patients with underlying diastolic dysfunction with~     oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices~     will improve metabolic and echocardiographic diastolic function parameters.~   "
53785|NCT02353299|"~     This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study.~     The study will assess the effects of a single dose of Silenor 6 mg compared with matching~     placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the~     respective T-max in normal healthy adult male volunteers. The study will be conducted in~     approximately 52 male subjects~   "
53786|NCT02353273|"~     The objective of this study is to evaluate the systemic exposures of WH-1 ointment which~     includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers~     following topical application of WH-1.~   "
53787|NCT02353260|"~     The purpose of this study is to determine whether Ultrasound Hyperthermia is effective and~     safe in the treatment of Oral and Maxillofacial-Head and Neck Cancer.~   "
53788|NCT02353247|"~     The overall objective of this study is to confirm that oral progesterone is an effective way~     to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel~     contraceptive implant in adolescents.~   "
53790|NCT02353221|"~     The CPMC early arthritis registry will recruit participants from a population of new~     patients undergoing evaluation at the office of participating physicians. Patients enrolled~     in the registry will undergo longitudinal observation and sampling. The investigators will~     collect questionnaire data and create a biological sample repository. The information~     obtained will be use to generate hypotheses aimed at explaining how environmental and~     genetic factors are interrelated to influence UA disease outcomes. Analysis will be~     performed on the patient's data and biological samples in order to; A. Assess the~     epidemiological and clinical characteristics of patients with early arthritis in the~     referral pool at CPMC.~      B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from~     individual patients based on their chemokine/cytokine secretion, cell adhesion molecule~     expression, gene expression, DNA methylation and non coding RNA profiles.~      C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used~     in the diagnosis, prognosis, and therapeutic decisions for patients with early UA~   "
53791|NCT02353208|"~     Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited~     by the battery life. In 20% of cases, the recording stops before the entire length of small~     bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the~     brain sends signal to the bowel to speed up motility. In this study the investigators wish~     to determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility~     and improve the rate of complete small bowel examination.~   "
53792|NCT02353195|"~     The aim of this study was to evaluate the potential clinical benefits of Monopolar~     Capacitive Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial~     chronic neck pain.~   "
53793|NCT02353182|"~     Animal studies suggest general anaesthetics harm the developing brain. It is unclear if~     these findings are relevant to humans but the issue has become a major concern. Recent data~     have found that monkeys exposed to anaesthesia as infants grow up to have slower learning~     than those not exposed.~      The aim of the TREX pilot study is to determine the feasibility of an alternative~     anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of~     age.~   "
53794|NCT02353169|"~     Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain~     in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a~     potential change in how the heart muscles contract and changes in blood sugar and potassium~     levels, are poorly understood. The current study aims to examine these changes directly in~     healthy children undergoing elective surgery by measuring the heart beats (with an~     electrocardiogram) and blood sugar and potassium at specific times before and after~     dexmedetomidine is given. The investigators aim to establish a better understanding of this~     drug's safety profile.~   "
53795|NCT02353156|"~     The investigator will perform a randomized clinical trials to compare the effect of pain~     management and wound healing after hemorrhoidectomy between warm sitz bath and electronic~     bidet.~   "
53796|NCT02353143|"~     The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion,~     in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and~     potential immunogenicity of MEN1112 will be evaluated as well.~   "
53797|NCT02353130|"~     Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in~     response to treatment with Memantine extended release (XR)®, an agent that modulates~     n-methyl d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders~     (ASD) who clinically demonstrate treatment response.~      Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will~     exhibit changes in their cortical metrics, which will differ less from neurotypical~     children. Subjective ratings of improvement will be correlated with the change in cortical~     metrics.~      The completion of these aims will be essential to design a larger federally funded trial to~     validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD~     sample. Specifically, the feasibility data obtained may demonstrate the potential for~     detecting changes in cortical metrics over time, so that a larger grant could focus on~     determining how sensitive and clinically relevant changes in cortical metrics are or may~     indicate the need to explore different interventions to use in a validation study. We have~     chosen to use Memantine XR® because of its impact on NMDA neurotransmission, its current~     evaluation in a large multi-site randomized ASD clinical trial whose initial results are~     expected shortly, and our own observations of clinical improvements and good tolerability in~     the ongoing trial.~   "
53798|NCT02353117|"~     Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated~     that half of them will have adverse birth outcomes. Congenital syphilis remains a major~     public health issue, despite the fact that maternal syphilis is easy to detect and treat.~     Multiple barriers impair the elimination of congenital syphilis. Syphilis is often~     stigmatized and of low priority, and even women attending prenatal care early are~     potentially facing multiple clinical barriers. The study objective is to use implementation~     research methods to evaluate a multifaceted intervention to increase the use of~     evidence-based clinical procedures to prevent congenital syphilis. The investigators will~     perform a facility-based, two-arm parallel cluster randomized implementation trial in the~     Democratic Republic of the Congo and Zambia. The intervention will be multifaceted, tailored~     by formative research, and include: opinion leaders, reminders, monitoring, and feedback;~     point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is~     positive. Improving syphilis screening and treatment will be promoted as a key step toward~     improving the quality of all components of prenatal care.~   "
53799|NCT02353104|"~     This open-label, adaptive-design, pilot study was designed to evaluate the effect of~     Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in~     systolic and diastolic blood pressures. The effect of the product on glucose metabolism,~     lipid levels, and antioxidant levels would also be determined. Tolerability and safety of~     the study product would also be investigated.~   "
53871|NCT02351973|"~     The purpose of this study is to determine whether the routine combination of optimal~     thiazide and K+-sparing diuretic will both increase efficacy of BP reduction and reduce risk~     of glucose intolerance; and whether K+-sparing diuretics alone may have a neutral or even~     beneficial effect upon glucose tolerance.~   "
53872|NCT02351960|"~     The purpose of this study is to evaluate the effectiveness of symptom control in~     gastroesophageal reflux disease (GERD) participants following treatment with~     dexlansoprazole.~   "
53800|NCT02353091|"~     Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer,~     middle, inner) are normal but the person has difficulty identifying or discriminating sounds~     (Dawes & Bishop, 2009) and experiences listening difficulties in noise. Personal Frequency~     Modulation (FM) systems are wireless listening devices that pick up the speaker's voice and~     transmit it to a receiver in the listener's ear. In this way, the negative effects of~     ambient noise, distance from speaker and reverberation are reduced (Keith & Purdy, 2014).~      The principal research question is whether FM systems improve auditory attention, listening~     in noise performance and listening in spatialised noise in children with Auditory Processing~     Disorder (APD) in relation to just auditory training alone. We hypothesize that the FM~     system will lead to improved attention scores, improved speech in noise perception (aided~     and unaided) and improved ability to listen in spatialised noise that after prolonged FM use~     (6 months). Additionally, we hypothesise that these results will correlate with~     questionnaires (filled out by parents, teachers and children).~      Thirty (30) children with a diagnosis of an APD from the Great Ormond Street Hospital~     Audiology clinic will be recruited. The children need to fulfil the following criteria:~        1. Diagnosis of APD (based on routine clinical tests at GOSH):~             1. Abnormal performance on the auditory figure ground test (a speech in noise test)~               of the SCAN-C (i.e. at the 1st percentile score as per UK norms), or in the~               High-Cue or Low-Cue score of the LiSN-S test and~             2. Abnormal performance in one non-speech auditory processing test (frequency~               pattern, duration pattern, gaps in noise or random gap detection pattern tasks),~               and~             3. Parent reported speech in noise and other listening difficulties.~        2. No neurological disorder, pervasive or attention deficit disorder or developmental~          delay.~        3. Normal IQ.~        4. Age range 8-11 years.~   "
53801|NCT02353078|"~     Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic~     esophagitis?~   "
53802|NCT02353065|"~     Colles fractures are a common type of wrist fracture that often requires manipulation in the~     Emergency Department. Currently xrays are used to assess whether this has been successful,~     which are done once the plaster cast has been applied. This study will assess whether~     ultrasound can be used immediately after the manipulation to check the position, before the~     plaster cast is applied. This would then be followed by an xray as normal.~      The aim is to assess the feasibility of a full study to determine which method is faster,~     causes less pain, and also to assess if either approach reduces the need for repeat attempts~     at manipulation and surgical repair.~   "
53803|NCT02353052|"~     Evaluate the reliability of morphology standards for GIST pathologic type, staging and~     grading by retrospective analyzing clinical data; on this basis, establish a GIST~     standardized and individualized treatment mode to maximum benefit GIST patients, avoid~     under- and over-treatment.~   "
53804|NCT02353039|"~     The purpose of this study is to evaluate the efficacy and safety of the investigational~     products in the patients with gastritis during their participation in the study.~   "
53805|NCT02353026|"~     This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose~     of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will~     be used, in which single patients will be enrolled to escalating dose levels until a grade 2~     or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6~     patients at each dose level until a dose is reached at which 2 or more patients out of 6~     experience a treatment-related toxicity.~   "
53806|NCT02353013|"~     The investigators will compare weight gain based on fat accretion and change in body~     composition in preterm infants receiving different amounts of enteral protein.~   "
53807|NCT02353000|"~     Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal~     survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the~     gold standard for patients with more than 3 brain metastases, but has significant side~     effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients~     with 4 up to 10 BM.~   "
53808|NCT02352987|"~     This study is designed to find out the effectiveness of combination of ethanol extract of~     neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar~     arsenical keratosis.~   "
53809|NCT02352974|"~     The objectives of this study is to~        -  Evaluate the safety of giving GAD-Alum (Diamyd) directly into lymph glands in~          combination with an oral vitamin D regimen~        -  Evaluate how the above mentioned treatments influence the immune system and endogenous~          insulin secretion.~   "
53810|NCT02352961|"~     There are both supply and demand gaps in our understanding of how best to implement MMC~     services. In terms of supply of MMC services, there is a need to better understand what the~     best way is of efficiently accessing mature men(25-49 years old) . The investigators also~     want to understand the type of service delivery approach and environment that would make~     mature men(25-49 years old) feel more comfortable when attending an MMC clinic. Demand of~     MMC requires identifying messaging that works to address mature men's (25-49 years old)~     issues so that they might be willing to undergo MMC. To further advance HIV prevention and~     advocacy of male circumcision the investigators also need to consider the perspectives of~     women on what approach MMC messaging should take. A combination of male and female~     viewpoints could inform MMC outreach messaging where IEC materials are tailored to address~     the barriers to MMC. Identifying the specific barriers to MMC among males and including the~     perspectives~   "
53811|NCT02352948|"~     This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy~     and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1 positive tumours~     and the combination of MEDI4736 plus tremelimumab (MEDI4736+treme) versus Standard of Care~     in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients~     with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2~     prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC.~     Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating~     mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study~     (prospective testing is not planned within this study). The Standard of Care options are: an~     EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine~     (NAVELBINE®).~   "
53812|NCT02352935|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress~     Free Survival (PFS) and Over Survival (OS) will be recorded.~   "
53813|NCT02352922|"~     The investigators are studying ways to improve pain control after surgery. One way to~     decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the~     operating room. There is an FDA approved extended-release version of a commonly used local~     anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are~     studying whether using the extended-release medication (Exparel) will give better pain~     relief after laparoscopic and robotic-assisted hysterectomies.~   "
53814|NCT02352909|"~     From a rehabilitation point of view, while several approaches exist to retrain runners with~     PFPS, it is not clear which one is most effective, or why. The goals of this~     randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation~     programs on pain and functional limitations of runners with PFPS and 2) to explain why the~     programs are effective or not based on laboratory analyses. After baseline evaluation,~     runners will be randomly assigned to one of three treatment groups, each with a specific~     8-week rehabilitation program aimed at addressing the efficiency of a specific type of~     retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading~     during running.~      The investigators hypothesis is that the intervention targeting a reduction in knee loading~     will be significantly more effective in reducing symptoms and improving function of runners~     with patellofemoral pain syndrome.~   "
53815|NCT02352896|"~     EPI-743 in Leigh syndrome subjects that participated in previous EPI743-12-002 study.~   "
53816|NCT02352883|"~     This clinical trial studies magnetic resonance imaging (MRI) and gene expression in~     diagnosing patients with abnormal cells in the breast duct that have not spread outside the~     duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed~     pictures of areas inside the body. MRI may help find and diagnose patients with breast~     cancer. It may also help doctors predict a patient's response to treatment and help plan the~     best treatment. Genetic studies may help doctors predict the outcome of treatment and the~     risk for disease recurrence. Performing MRI with genetic studies may help determine the best~     treatment for patients with breast cancer in situ.~   "
53817|NCT02352870|"~     To explore whether it is feasible to recruit and retain haemodialysis patients into a~     randomised controlled trial of online cognitive-behavioural therapy to manage distress~   "
53818|NCT02352857|"~     The study aims to evaluate the glycaemic and insulinaemic response of short-chain~     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.~   "
53819|NCT02352844|"~     The purpose of this research study is to look at participants with solid tumor malignancies~     and specific mutations respond to treatment with everolimus.~   "
53820|NCT02352831|"~     There are two parts to this study: the goal of the first part of the study is to find the~     best dose of tosedostat when given in combination with capecitabine. The goal of the second~     part of the study is to look at how participants respond to treatment with tosedostat and~     capecitabine.~   "
53821|NCT02352818|"~     The aim of this CTO registry is to gather data including patient demographic date, cardiac~     risk factors, procedural technical data and procedural success/outcome rates. Furthermore,~     we aim to evaluate the safety and performance of various CTO specific guidewires, devices~     (such as the CrossBoss/Stingray dissection ren-entry device) and other recognised and~     approved techniques (retrograde wire escalation, retrograde dissection re-etry techniques).~     The incidence of recognized complications (dissections, perforations, cardiac tamponade,~     vascular complications, radiation injury, acute kidney injury) will also evaluated. We will~     assess clinical outcome at 1 year after succesful CTO procedures.~   "
53822|NCT02352805|"~     This observational clinical study investigates cellular and plasmatic activation markers as~     well as proteins involved in coagulation and inflammation in patients being connected to~     different extracorporeal circulation (ECC) and circulatory support devices under intensive~     care conditions.~   "
53823|NCT02352792|"~     Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a~     hypoxia scan either by magnetic resonance tomography, computed tomography or~     fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into~     standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus~     either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy)~     to the hypoxic volume applied via simultaneous integrated boost in addition to the standard~     treatment (Arm B).~   "
53824|NCT02352779|"~     This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related~     fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce~     cancer-related fatigue in breast cancer survivors.~   "
53825|NCT02352766|"~     Recently, targeted next generation sequencing (NGS) platforms have been introduced that~     allow inexpensive testing for hundreds of mutational hotspots at the same time. A number of~     additional mutational markers in thyroid cancer have been identified. Highly promising~     markers associated with tumor prognosis have also been found. This multi-institutional study~     aims to validate the diagnostic use of mutational markers in thyroid nodules with~     indeterminate cytology.~      The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a~     large panel of mutational markers applied to thyroid FNA samples can provide an accurate~     cancer risk stratification in thyroid nodules.~      The performance of the panel will be tested in a multi-institutional double-blind~     prospective study of FNA samples from thyroid nodules with indeterminate cytology and~     available surgical outcome~   "
53826|NCT02352753|"~     This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with~     OI to evaluate efficacy and safety of denosumab.~   "
53827|NCT02352740|"~     The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine~     in healthy subjects featuring metabolic syndrome related risk factors~   "
53828|NCT02352727|"~     To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients~     compares with their spouses by using multisite accelerometers for 1 night at their home. To~     determine whether the nocturnal movement of Parkinson's disease patients less than normal~     elderly people or not.~   "
53829|NCT02352714|"~     This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual~     analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a~     paracervical (n=46) block versus a sham paracervical block (n=46).~   "
53830|NCT02352701|"~     This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg,~     Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication~     treatment of H.pylori~   "
53831|NCT02352688|"~     This study evaluates the effects of enhanced geriatric input on elderly patients undergoing~     colorectal cancer surgery. Half of the participants will received additional pre, peri and~     post-operative care from the geriatric team, while the other half will receive standard~     surgical care.~   "
53832|NCT02352675|"~     Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are~     antifibrinolytic agents routinely administered in children undergoing different surgeries~     associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries).~     Although there is a growing literature regarding the pharmacokinetic characteristics of~     these drugs in children, the plasmatic concentration required to completely inhibit~     fibrinolysis remains to be determined. In this in vitro study, the investigators will use an~     experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to~     determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In~     addition, this study will be used to create and validate a new experimental assay to measure~     fibrinolysis and the effect of antifibrinolytic agents.~   "
53833|NCT02352662|"~     This prospective study will aim to globally assess the coagulopathy induced during cardiac~     surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators~     primary objective will be the understanding of CPB-induced coagulopathy based on demographic~     and surgical characteristics, and coagulation assays. Secondary objective will aim at~     determining the relationship between coagulation assays, postoperative blood loss, and~     transfusion requirements. The ultimate goal will be to design an algorithm using~     point-of-care monitoring that could be used to guide hemostatic therapies in neonates and~     children undergoing cardiac surgery.To do this, investigators will examine the coagulation~     in the laboratory based setting.~   "
53834|NCT02352649|"~     The purpose of this study is to determine safety and efficacy of pl-vegf165 (Neovasculgen)~     for regeneration of peripheral nerve. Pl-vegf165 (Neovasculgen) is the permitted in~     Russian Federation angiogenic medication that induce growth of new vessels and included in a~     complex therapy for patients with peripheral arterial diseases in Russia. It has also been~     shown to enhance nerve regeneration and muscle reinnervation in animals but these properties~     have not previously been studied in patients. Moreover, currently there is no method in~     clinical use to speed the rate of recovery after nerve injury. The objective of this study~     is to explore the ability of pl-vegf165 to benefit the treatment of patients with peripheral~     nerve injury. The investigators hypothesize that treatment with intraneural injections with~     pl-vegf165 after peripheral nerve reconstruction will accelerate nerve regeneration, reduce~     the period of denervation and improve muscle reinnervation and recovery in patients with~     peripheral nerve injury.~   "
53835|NCT02352636|"~     Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent~     condition in the ageing population. With disease progression, some clients may develop~     severe pain and profound limitations in ambulation, which may result in morbidity and~     impaired physical functions. Among the available treatments, pharmacological therapies~     primarily focus on musculoskeletal pain relief. However, adverse effects, such as~     gastrointestinal haemorrhage arising from non-steroidal anti-inflammatory drugs have led to~     an increasing number of concerns regarding the use of these treatments. Other non-invasive~     complementary methods for osteoarthritic knee (OA knee) should be explored because of the~     limitations of pharmacological therapy.~      Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a~     therapeutic method by which specific points on the auricle are stimulated to treat various~     disorders of the body. The present study is a four-arm randomised controlled study to~     determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve~     the conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT~     in terms of alleviating pain, relieving stiffness and promoting a range of motion, and~     enhancing functional abilities will be determined.~      Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of~     the ear during each treatment session. A deactivated laser will be used to achieve the~     effect of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy~     laser applied to selected acupoints of the ear, and a plaster centred with a portion of~     Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3'~     will receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will~     serve as placebo controls. Six auricular acupoints that are considered to have an effect on~     the OA knee will be selected. Only one ear at a time will receive treatment. Thus, the ears~     will be treated alternately. The total treatment period will be four weeks. The experimental~     objects will be replaced every other day. Therefore, treatment will be performed thrice a~     week. Subjects will be assessed at baseline up to 3 months after the therapy. This study~     could advance the knowledge on the complementary approaches than can be used to improve OA~     knee conditions in the elderly.~   "
53836|NCT02352623|"~     Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.~   "
53837|NCT02352610|"~     A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon~     Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an~     interference screw for thumb carpometacarpal arthritis~   "
53838|NCT02352597|"~     Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were~     randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50~     mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received~     2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50~     women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.~   "
53839|NCT02352584|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III~   "
53840|NCT02352571|"~     The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase~     2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous~     (IV) infusion to patients with stage IV solid tumors.~      The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118~     and explore prognostic biomarkers and pharmacodynamic biomarkers.~   "
53841|NCT02352363|"~     This study is a 12-month, open-label, randomized, multicenter study which will evaluate the~     safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in~     Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will~     include a concurrent observational cohort of PD patients managed using the usual standards~     of care.~   "
53842|NCT02352350|"~     Blood lactate levels will be measured using a simple handheld device at time of return of~     spontaneous circulation (ROSC) following out of hospital cardiac arrest (OHCA). Patient~     outcomes tracked will include rate of survival to hospital discharge, rate of 6 month~     survival, and neurological status. The hypothesis for this pre-hospital study is to confirm~     the previous in-hospital findings that very high blood lactate after ROSC is associated with~     very high mortality and severe neurological impairment.~   "
53873|NCT02351947|"~     The purpose of this research study is to improve methods for evaluation of brain changes~     during motor learning for patients with stroke, who have difficulty performing daily tasks~     with their arm and hand. The methods for evaluation of brain changes will consist of the~     combination of magnetic resonance imaging (MRI) and electroencephalography (EEG).~   "
53874|NCT02351934|"~     This study will assess if administration of a loop diuretic, specifically furosemide, to~     achieve euvolemia can safely reduce length of stay following colorectal surgery.~   "
53843|NCT02352337|"~     The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years~     is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease~     with the survival median of 2-4 months without chemotherapy.~      Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until,~     the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months~     with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3~     months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main~     toxicities of this treatment are hematological, gastrointestinal and neuropathy with~     apparition of sensitive neuropathy, reversible, related to oxaliplatin.~      These results are on a population under 76 years old. In this study, the median age of~     patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more~     than 65 years old. Given the increase of proportion of patients than more of 65 years old~     with pancreatic cancer and given the increase of life expected, it is important to know the~     effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.~      FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4~     cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross~     resistance known between this 2 treatments witch limit toxicities and preserve quality of~     life of patients. A Phase II trial testing this treatment regimen to classical regimen of~     gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall~     survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of~     progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this~     strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line~     of treatment.~      The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8~     cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without~     decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference~     regimen.~   "
53844|NCT02352324|"~     The main goal of our study is to assess the accuracy and reproducibility of continuous~     beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients~     undergoing off-pump coronary artery bypass grafting.~   "
53845|NCT02352311|"~     This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study~     to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and~     tadalafil) in healthy male volunteers.~   "
53846|NCT02352298|"~     The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor~     (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals~     and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings~     to readings obtained from the YSI 2300 STAT Plus glucose analyzer.~   "
53847|NCT02352285|"~     The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum~     Na levels in patients with worsening heart failure and hyponatremia.~   "
53848|NCT02352272|"~     Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive~     performances before, during total sleep deprivation (39 hours continuous awaking) and after~     a subsequent recovery sleep.~      Design: Subjects participated in two experimental conditions (randomized cross-over design):~     extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition,~     subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three~     experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of~     recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in~     laboratory.~      Setting: This cross-over and randomized study was conducted under standardized laboratory~     conditions with continuous polysomnographic recording Participants: 14 healthy men (age~     range: 26-37 years) participated in the study.~      Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr~     continuous awaking).~   "
53849|NCT02352259|"~     The study is prospective, phase II study, The primary objective of the study is evaluation~     of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver~     metastases. The secondary objective is to determine the efficacy of electrochemotherapy~     treatment, based on histological and radiological evaluation of treated metastases. The~     endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events~     (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST~     criteria.~   "
53850|NCT02352246|"~     Postmenopausal women, as men, are more prone to central or android obesity. Abdominal fat~     mass is associated with an increase of cardiovascular diseases (CVD). In type 2 diabetic~     (T2D) patients, the risk of CVD mortality is more than double compared with that in~     age-matched subjects.~      Most exercise programs designed for weight loss have focused on steady-state exercise (SEE)~     of around 30 min at a moderate intensity several times a week. Disappointingly, these kinds~     of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating~     evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be~     an effective exercise protocol for reducing fat of overweight individuals, especially at the~     abdominal level (Boutcher 2011, Kessler 2012). Despite these results, HIIE program has never~     been used in TD2 postmenopausal women to favor a specific decrease of abdominal fat mass.~      The aim of our study was to compare the effects of 16-week steady-state exercise (SSE)~     program with high intensity intermittent exercise (HIIE) program on total abdominal and~     visceral fat mass in T2D postmenopausal women.~      It is hypothesized that HIIE compared to SSE program would result in significantly greater~     reductions in total abdominal and visceral fat mass.~   "
53851|NCT02352233|"~     Colonoscopy is the gold standard technique for diagnosis and treatment of colonic lesions.~     Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown~     better results regarding adenoma and polyps detection when compared to standard non HD~     scopes. However, evidence shows that during standard colonoscopy many lesions could be~     missed, including polyps, cancer and other kind of lesions. This could be correlated to many~     factors and recently reports show evidence that lesions behind the folds could be missed~     because the limitation of a forward view examination. Until know, a new auxiliary imaging~     device called Third Eye Retroscope had demonstrated more lesions detection during~     colonoscopy using a retro view, but with some limitations as absence of HD vision, the need~     of additional equipment and the fact the device occupies the accessory channel, limiting~     therapeutic efficiency. Recently a new HD colonoscope called RETROVIEW (PENTAX Medical)~     has been developed. It permits visualization of colonic mucosa in forward view, in retroflex~     view and allows for performance of diagnostic and therapeutics in a single colonoscope.~   "
53875|NCT02351921|"~     This study will investigate how repetitive transcranial magnetic stimulation delivered as a~     protocol called 'continuous theta-burst stimulation (cTBS)' alters motor output and force~     control to a muscle in the forearm and touch perception in individuals with chronic,~     incomplete spinal cord injury. CTBS is a non-invasive technique that involved repetitive~     delivery of transcranial magnetic stimulation at a frequency of 30 Hz over the arm~     representation in the primary motor or sensory cortex. The purpose of this study is to~     determine whether cTBS is an effective intervention to increase motor output to a muscle and~     increase force control of that muscle and also improve the sense of touch.~   "
53852|NCT02352220|"~     COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in~     the patient's quality of life, high prevalence, growing incidence and socioeconomic~     implication. COPD natural history and first stages determinants are unknown. Knowing them~     will help to understand the natural history of the disease and to design interventions that~     can modify the prognosis of the disease.~      Study objectives: (1) To characterize an early COPD population from a multidimensional point~     of view including demographic, social, family and clinical data, lung function, exercise~     capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and~     sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung~     function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in~     the future to understand the complete natural history of the disease.~      Methods: Design: multicenter cross-sectional study that will allow establishing a~     well-characterized cohort of early COPD patients for later follow-up. Recruitment will be~     done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old~     with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be~     based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in~     the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy'~     smoker controls will be compared with the COPD cases. Variables that will be collected in~     the reference hospitals are: health questionnaires, lung function test, exercise capacity,~     blood and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's~     characteristics will be described and then, will be compared, with control subjects through~     a conditional multiple logistic regression analysis.~   "
53853|NCT02352207|"~     This research focuses on lung malformations detected in fetuses during prenatal ultrasound~     exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved~     knowledge is needed, to give families better information, and to better standardize~     treatment decisions The main goal is to better predict neonatal complications associated~     with these malformations, by identifying key predictive markers during the fetal period.~      To achieve this objective, it is planned to include 400 pregnant women with prenatal~     diagnosis of pulmonary malformation in 45 health centers in France. This is the largest~     study on this topic at the international level.~   "
53854|NCT02352194|"~     The purpose of this study is to assess the physical capacity of patients with multiple~     sclerosis and the effects of rehabilitation, encompassing physical therapy and physical~     activity as it is carried out in the day hospital of (the Physical and Rehabilitation~     Medicine department) at Garches Hospital. We will compare the results of assessments carried~     out before and after a standard rehabilitation program.~   "
53855|NCT02352181|"~     In current practice, management of coagulation during liver transplantation is performed~     either through standard coagulation status or with ROTEM® depending on practitioner choice~     and availability of materials. In this context, the ROTEM® is used since over 2 years by~     anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon,~     France.~      Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy~     developed by patients who are eligible, due to coagulation factor synthesis deficiencies in~     the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection~     of coagulopathy in such patients because the imbalance between pro- and anti-coagulant~     factors are not taken into account by PT and aPTT measures. Management of intraoperative~     hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which~     allows the detection of abnormalities in the balance between pro- and anti-coagulant~     factors.~      This technique was already evaluated in liver, cardiac, and obstetric surgery but also in~     traumatology. Randomized trials in liver transplantation surgery have shown changes in~     transfusion practices but did not focus on the consequences of such changes.~   "
53856|NCT02352168|"~     The purpose of this study is to determine whether treating upper airway with intranasal~     corticosteroids in children with allergic rhinitis and no asthma may bring favors in~     reducing lower airway inflammation and improving small airway function.~   "
53857|NCT02352155|"~     Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in~     those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion,~     surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them~     will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold~     higher. In the few who need surgery, mortality approaches 30%. Prevention of further~     bleeding is therefore a major treatment objective. Currently the investigators use a high~     dose infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a~     previous randomized trial, the investigators showed that the rate of bleeding in 30 days was~     around 7% with such an approach. In a small subgroup of high risk patients defined by~     presentation with shock and ulcers > 2 cm in size, 1 in 6 would re-bleed. An alternate~     strategy is to select those at especially high risk of further bleeding and repeat~     endoscopic treatment the next morning. The investigators have shown that persistence of~     major bleeding stigmata, i.e. a visible vessel, during a second endoscopy predicts further~     bleeding. It is therefore logical that by repeating endoscopic treatment the next morning,~     the investigators can prevent further bleeding and possibly surgery and deaths. The current~     study proposes to develop a score to identify those at risk of further bleeding after~     endoscopy. The investigators used a historical cohort with carefully collected clinical data~     to derive a risk score. In this derivation phase of 939 patients, the investigators have~     developed a 9 point risk score which consists of the following parameters (Age>60, Male sex,~     ulcer>2cm, posterior bulbar in location, spurting or Forrest Ia bleeding and admission~     hemoglobin of < 8 g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been~     shown to highly predictive of further bleeding. The score will then be validated in a~     prospective cohort of patients with bleeding peptic ulcers. In the final phase of this~     study, the investigators propose a randomized controlled trial to test the hypothesis that a~     second look endoscopy with treatment in selected high risk patients can further reduce~     bleeding and improve their outcomes. After endoscopic hemostasis to their bleeding peptic~     ulcers, patients are risk stratified based on the score. Those with a score of 5 or more are~     randomized to receive the standard treatment (a high dose PPI infusion) or a second look~     endoscopy with treatment in addition to PPI infusion. The primary outcome to the trial is~     further significant clinical bleeding.~   "
53858|NCT02352142|"~     The purpose of this proposal is to conduct a replication study of Family Nurture~     Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to~     early development. These include early and repeated mother/infant calming interactions~     during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal~     olfactory exposure and family practice in comforting, and systematically implemented skin to~     skin holding. This has already been studied at CHONY. Findings reveal that infants who~     receive FNI have significant increases in EEG power, a measure of brain activity, near to~     term age, when compared with those who receive Standard Care.~      There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot~     subjects will be enrolled to train the staff involved in the procedures used in this~     Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study~     patients and will be encouraged to participate fully. They will not be included in the~     analysis of the RCT.~      The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION~     group, in addition to the standard care, will receive the FNI intervention, which will be~     facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be~     a third non-randomized group of infants born at term age who will receive standard care for~     newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG),~     measures of maternal sensitivity through recorded mother-infant interactions and a variety~     of specimen collections (saliva, blood, and breast milk samples). The investigators will be~     conducting two follow up studies, at 4 months corrected age and at 12 months corrected age.~     The investigators will test the immediate and long-term effects of this approach to the~     development of preterm infants.~      The investigators hypothesize that this intervention will alter a wide range of indices of~     physiological regulatory capacities, and increase brain activity as measured by EEG (power~     and coherence) such that a brain activation pattern in the intervention group will be more~     similar to that of full term infants as opposed to the standard care group. Longer term~     indices of mother psychological and infant neurobehavioral outcomes will also be improved~     when assessed during the first few months of life.~   "
56297|NCT02320227|"~     To evaluate the safety of a personal lubricant when used as indicated as a personal~     lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks~     in a population of healthy females~   "
53859|NCT02352129|"~     : Fibrosis, in general, is a scarring process, which is characterized by fibroblast~     accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to~     distorted organ architecture and function. The contribution of fibrogenesis to impaired~     cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and~     induces pathological signaling within cardiomyocytes resulting in progressive cardiac~     failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and~     increases the risk of arrhythmias. But today patient treatment and prognosis is based on~     ejection fraction quantification, QRS duration, and symptoms.~      Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared~     with normal value, is of prognostic value in patient with dilated cardiomyopathies under~     optimal treatment.~      Methods: 330 patients are planned to be included and followed for 2 years~   "
53860|NCT02352116|"~     This study aims to assess the differences in overall pain severity, pain management, and~     satisfaction during recovery period between two groups of children who either receive or do~     not receive additional education related to expectation and management of postoperative~     pain.~   "
53861|NCT02352103|"~     To assess and compare the short-term post-operative continence recovery rate in two cohorts~     of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo~     RARP with Vattikuti Institute technique or Retzius sparing technique.~   "
53862|NCT02352090|"~     The main objective of the study is to compare the metabolic effects of natural estradiol and~     synthetic ethinylestradiol used in combined oral contraception in healthy women. A~     progestin-only preparation will be used in comparison. The main goal is to study the effects~     on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).~     Our hypothesis is that the natural estradiol preparation will influence blood glucose~     levels, markers of coagulation and chronic inflammation less than the ethinylestradiol~     preparation. The progestin-only preparation will not effect these parameters.~   "
53863|NCT02352077|"~     The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with~     bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with~     chronic spinal cord injury.~   "
53864|NCT02352064|"~     Allogeneic stem cell transplantation was developed to cure many patients with hematological~     malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of~     cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver,~     gastrointestinal tract) and / or the observation of typical clinical signs sufficient for~     diagnosis. However, the anatomical sites for biopsy including the digestive tract are not~     clearly identified (high or low biopsy) and may present risks in their realization in~     particular in patients weakened by blood disease or immunosuppression.~      PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as~     Crohns disease with good sensitivity and specificity. It interest in the graft against the~     host was studied in acute forms of digestive and allows lesion mapping and monitoring the~     effectiveness of treatment.~      Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view~     musculoskeletal uptakes localized to the affected areas identified with MRI.~      The investigators propose a study evaluating the sensitivity and specificity of the~     examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional~     diagnostic tools.~   "
53865|NCT02352051|"~     The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and~     osmotic release oral system-methylphenidate (OROS-MPH) therapies on executive functions,~     activities, treatment response time and adverse effects based on discernible clinical~     effects in children with combined type attention deficit-hyperactivity disorder (ADHD).~   "
53866|NCT02352038|"~     The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients~     with periodontitis during orthodontic-periodontal treatment for 12 months on the following~     aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3)~     Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.~      To eliminate any bias, the investigators will initially hypothesize that there is no~     difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of~     life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic~     treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.~   "
53867|NCT02352025|"~     The primary objective of this study is to determine if S-equol, an ER-beta agonist, is~     effective in decreasing the proliferation rate of triple negative breast cancer.~   "
53868|NCT02352012|"~     The purpose of this study is to determine whether injecting autologous blood or putting~     bronchial plug through bronchoscope is effective in the treatment of refractory~     pneumothorax.~   "
53869|NCT02351999|"~     The study is a prospective, multi-center, non-randomized single arm interventional~     investigation with the TSP Crosser Transseptal Access System, a new complete solution for~     transseptal puncture and left atrial access and catheter navigation, for patients with~     atrial fibrillation ablation referred for radiofrequency catheter ablation.~   "
53870|NCT02351986|"~     Background: Subacromial impingement syndrome (SIS) is a chronic and disabling disease,~     characterized by compression and mechanical abrasion of the tendons of the rotator cuff~     muscles, subacromial bursa and tendon of the long head of the biceps against the anterior~     surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm~     elevation movement. After the trauma, inflammatory processes initiate and may lead to loss~     of function when untreated. This inflammation leads the release of cytokines (IL-6, IL-10,~     IL-1β and TNF-α) whose acts as inflammatory mediators. Physical therapy works in treating~     SIS with the goal of reducing pain and inflammatory process. Cryotherapy is widely used in~     physical therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and~     easy application. Objective: The aim of the study is to evaluate the effects of a~     cryotherapy protocol, applied on shoulder of subjects with SIS, on serum inflammatory~     mediators (cytokines) and local pressure pain threshold. Possible changes in function and~     pain will also be evaluated. Materials and Methods: 30 subjects will be selected and share~     in two groups, 15 healthy subjects and 15 subjects with SIS. Function assessments and~     quality of life will be held using the DASH and WORC questionnaires. Cryotherapy will be~     applied for 4 consecutive days, lasting 20 minutes without interruption through ice pack~     over the shoulder of SIS carriers. For the blood samples, 20ml of blood will be collected at~     the first and last day of the intervention, and then stored at -80 ° C.~   "
53876|NCT02351908|"~     The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its~     impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or~     Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment~     for HIV infection for the first time.~      All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a~     single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by~     the national guide-lines and used in standard clinical practice.~   "
53877|NCT02351895|"~     This is a prospective Infection Control study comparing rates of antibiotic usage and~     infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens~     versus regular linens.~   "
53878|NCT02351882|"~     Alzheimer's disease (AD) is commonly associated with behavioural changes such as agitation.~     Severe agitation is important to treat because it not only increases progression of AD and~     physical health problems (increased falls and weight loss), but it also decreases quality of~     life and increases caregiver stress. Currently prescribed treatments (i.e., antipsychotics)~     for agitation in AD do not work in everybody and when they do work the effect is small and~     they increase the risk of harmful side effects, including death. As a result, there is an~     urgent need for safer medication options. The cannabinoid nabilone can now be prescribed in~     capsule form for appetite and pain killing effects. Nabilone's calming effects may benefit~     those with agitation, and help the weight loss and untreated pain frequently associated with~     agitation. Through a clinical trial, the investigators hope identify the benefits of~     nabilone in the treatment of agitation in AD.~      The investigators objective is to determine whether nabilone is an efficacious and safe~     treatment for agitation, as well as having benefits for pain, weight and behavioural~     symptoms. This will be a 14 week clinical trial (participants take nabilone for 6 weeks,~     placebo for 6 weeks (order randomized) with 1 week between treatments). The investigators~     will assess and compare agitation, weight, pain, memory, behaviour and safety.~      Nabilone is a new class of medication that may be a safe and effective treatment for~     agitation in AD, with added benefits on appetite and pain. Reducing these symptoms would~     increase quality-of-life and reduce caregiver stress.~   "
53879|NCT02351869|"~     This study is a 7-day randomized, double-blind proof-of-concept pilot study of nitrous oxide~     vs. midazolam in 40 adults (20-60 years) with bipolar disorder (BD) (type I or II). Ongoing~     pharmacological and psychosocial treatments may continue, provided that they have not been~     initiated or significantly modified in the preceding 2 weeks. Participants' current~     treatment as prescribed by clinical psychiatrists will not be modified or interfered in this~     study. The study involves 3 visits. During study visit 1, participants will complete~     screening to ensure study eligibility. This will be done using interview measures. During~     study visit 2, participants will complete anthropomorphic measurements, measurement of~     endothelial function, screening blood work, ECGs, and an anaesthesia screener. During study~     visit 3, participants will receive the treatment (nitrous oxide or midazolam), complete an~     MRI scan, and complete interview measures and self-reports. There will be anthropomorphic~     measurements taken as well. The participant will be required to complete phone interviews~     and self-reports over the subsequent 7 days. There are 4 main predictions: 1. Nitrous oxide~     will significantly reduce depression symptoms vs. midazolam. 2. Nitrous oxide will~     significantly increase frontal cortical perfusion vs. midazolam. 3. Lower perfusion in~     frontal cortical regions at baseline will be associated with greater improvement in~     depression symptoms following nitrous oxide treatment. 4. Poorer endothelial function will~     be associated with greater improvement in depression symptoms following nitrous oxide~     treatment.~   "
53880|NCT02351856|"~     This is a rollover study designed to investigate the safety and effectiveness of~     investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a~     study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and~     may, in the Investigator's opinion, derive benefit from continued treatment.~   "
53881|NCT02351843|"~     The purpose of this study is to demonstrate the clinical feasibility of low amplitude~     electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by~     lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low~     amplitude ECT could potentially reduce the risks associated with ECT while preserving its~     unparalleled efficacy. This novel development would remove key obstacles to allow for the~     wider adoption of ECT as a safe and effective therapy.~   "
53882|NCT02351830|"~     The EEU has proven effective in multiple studies evaluating various aspects of seasonal~     allergic rhinitis. All previous EEU clinical trials have utilized ragweed or grass pollen as~     the allergen of choice for dispersal, due to the local population, but many emerging~     treatments for allergic rhinitis are allergen specific, thus it is desirable to expand the~     repertoire of pollen selection for use in the EEU. Ragweed, grass and birch pollen have~     differing appearances and sizes but essentially, both have characteristics which promote the~     ability to keep the pollen grains suspended and hence, the ability to maintain proper~     concentrations within the EEU. Preliminary validation studies conducted in the EEU, absent~     of human volunteers, have confirmed our ability to release, disperse and maintain birch~     pollen concentrations in the EEU using the existing technology.~      This study aims to validate the use of birch pollen on a clinical scale. By adding non-~     allergic participants into the EEU, the investigators hope to determine if non-allergic~     persons exhibit differences at baseline in their epigenetic biomarkers from those who have~     pre-existing and established allergic airways inflammation.~   "
53883|NCT02351817|"~     The primary objective of the investigation is to explore the acceptance of a newly developed~     adhesive.~   "
53884|NCT02351804|"~     The purpose of this study is to investigate whether dexamethasone as an adjuvant to~     ropivacaine for adductor canal block increases duration of the sensory block, when~     controlling for a systemic effect using a paired design and bilateral blocks.~      The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block~     duration compared with ropivacaine + placebo.~   "
53885|NCT02351791|"~     The primary purpose of the study is to investigate the impact that feces mixtures have on~     the peristomal skin when using a standard adhesive.~   "
53997|NCT02350335|"~     All patients with acute aneurysmal hemorrhage are treated in accordance with our~     institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal~     hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and~     long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and~     smokers with NRT.~   "
53886|NCT02351778|"~     In study the investigators sought to~        1. Assess the quality of life experience in stable post stroke survivors in Pakistan and~          detail important factors influencing quality of life.~        2. Explore the association between primary care giver`s quality of life and stroke~          survivor's quality of life.~        3. To validate the quality of life tools and experience via in depth interviews and focus~          group discussion with the primary care giver of stroke patients to report the quality~          of life of the primary care giver.~   "
53887|NCT02351765|"~     The purpose of this study is to determine the recommended phase II dose, and to assess the~     safety of acelarin in combination with cisplatin in patients with locally advanced/~     metastatic biliary tract cancers.~   "
53888|NCT02351752|"~     IgA nephropathy is the most common type of primary glomerulonephritis and might caused by~     deposition of immune complex containing IgA in mesangium and causing local immune~     activation. Hydroxychloroquine reduces the activation of dendritic cells and the~     inflammatory process and showed the potential effect of treatment of patients with IgA~     nephropathy.~      The investigators study will recruite IgA nephropathy patients with proteinuria range from~     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were~     treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded~     every two months and total four months. Then, the drug will be stopped for two months for~     observation of change of proteinuria.~   "
53889|NCT02351739|"~     Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant~     Metastatic Urothelial Cancer~   "
53890|NCT02351726|"~     Prospective, non-randomized, multicenter post-approval study to collect long term clinical~     and echographic data on Mitroflow DL patients.~   "
53891|NCT02351713|"~     Therefore, the purpose of this study is to compare the effectiveness of two exercise~     training programs for improving cardiorespiratory fitness: the ACE three-zone training model~     (i.e., threshold based training) versus the more common ACSM recommended relative percent~     method (i.e., %HRR).~      It is hypothesized that:~        1. The ACE three-zone training model will elicit greater mean changes in cardiorespiratory~          fitness (as measured by VO2max) when compared to the relative percent method.~        2. Participants in the ACE three-zone training model group will be more likely to have~          favorable VO2max responses; while comparatively, participants in the relative percent~          method group would be more likely to experience a VO2max nonresponse to exercise~          training.~   "
53892|NCT02351700|"~     A randomized, double-blind, placebo-controlled intervention trial involving 100 treated~     subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion.~     Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50~     treated in the standard post-operative medication arm.~   "
53893|NCT02351687|"~     Children who recover from moderate acute malnutrition in Malawi remain at high risk for~     relapse or death in the year following recovery. This cluster-randomized trial will evaluate~     a package of affordable, safe, proven interventions specifically targeted to this population~     of children in an attempt to decrease their risk of relapse or death following recovery from~     moderate acute malnutrition. These children will be followed for a year following recovery~     to assess rates of relapse and mortality.~   "
53894|NCT02351674|"~     The trial is a single centre, retrospective cohort, non-interventional study to be conducted~     in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate~     the link between mean perioperative clinical heart rate and short-term composite outcomes~     during PCI among local CHD patients.~   "
53895|NCT02351661|"~     The Nutrition Care In Canadian Hospitals study, conducted by the Canadian Malnutrition Task~     Force had the primary purpose of determining the prevalence of malnutrition in Canadian~     acute care hospitals. Secondary objectives were to determine the independent association of~     malnutrition with patient centred outcomes (e.g. length of stay) and describe the nutrition~     care processes for malnourished and well nourished patients.~   "
53896|NCT02351648|"~     To find out if a transitional care model can reduce the rate of unscheduled readmission to~     the Department of Internal Medicine (DIM) in SGH~   "
53897|NCT02351635|"~     The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN~     fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD;~     Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel~     Syndrome (IBS).~      To estimate the predictive value of a positive test (positive predictive value (PPV)) and~     the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed~     test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for~     diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.~      To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.~      To provide exploratory observations of test results in patients between the age of 2 and 21~     years.~      To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal~     disease for use in Expected Value Testing.~   "
53898|NCT02351622|"~     The investigators are undertaking a multicentre, randomised controlled trial of 120 adults~     with newly diagnosed ITP from 5 medical centers in China. Part of the participants are~     randomly selected to receive caffeic acid tablets combining dexamethasone and the other part~     are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and~     other symptoms were evaluated before and after treatment. Adverse events are also recorded~     throughout the study.~   "
53908|NCT02351492|"~     Patients with gallstone disease should be checked whether a common bile duct (CBD) stone~     could be present. In case of a certain suspicion for CBD stones further investigations~     should be performed. This can either be done by magnetic resonance~     cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study~     investigates which pathway would be favorable in regard of an early hospital demission.~   "
53909|NCT02351479|"~     A six-month interventional program to determine the biological and psychosocial effects of~     hula as a form of physical activity for female breast, cervical, endometrial or ovarian~     cancer survivors living on Oahu.~   "
53975|NCT02350621|"~     A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with~     radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive~     posterior cervical foraminiotomy.~      80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications,~     health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively~     (foraminotomy group).~   "
53899|NCT02351609|"~     Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden,~     smoking rates must be reduced among populations where smoking is disproportionately~     concentrated: those with low socioeconomic status (SES). The investigators will apply two~     methods that are being used in the field of health disparities to the challenge of promoting~     smoking cessation among low SES smokers. These include: 1) Patient navigation; patient~     navigators are often lay persons, working as paid employees, who guide patients through the~     health care system and 2) Financial incentives; investigators propose to provide monetary~     incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for~     an additional 6 months of abstinence after the initial cessation. The investigators will~     recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of~     Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced~     Traditional Care control condition (smoking cessation brochure/list of cessation resources).~     The RCT will take place among adult daily smokers seen in the past year at BMC primary care~     practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone,~     for both groups, will occur 6, 12, and 18 months after enrollment.~   "
53900|NCT02351596|"~     This study aims to determine if participation in a core stability physiotherapy group~     programme can improve the balance of children with cerebral palsy. It is hypothesised that~     teaching the children how and when to activate their deep core stabilising muscles may help~     improve their body awareness and their ability to control their alignment and therefore~     positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who~     can walk independently, will be randomly selected to join either the control group or~     intervention group, after completion of their baseline balance assessments. Each group will~     be re-assessed after completion of their 4 week intervention or control period.~   "
53901|NCT02351583|"~     Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major~     cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation~     with subsequent release of inflammatory mediators leading to a generalized endothelial~     dysfunction. It is now accepted that endothelial dysfunction heralds the clinical~     manifestations of preeclampsia.~      The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth~     region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black.~     SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was~     used before in many situations especially in sepsis and septic shock patients.~      Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR)~     light by tissues perfused with oxygenated blood, and is capable of measuring changes in~     parenchymal volume tissues. It was used before in many situations (including pregnant~     patients) to reflect the tissue oxygenations.~      The investigators are planning to use the SDF and NIRS tools to study the microcirculatory~     change in preeclamptic subjects and normal pregnant subjects. If these two devices are able~     to determine any changes this should stand as a baseline for future studies in this field.~   "
53902|NCT02351570|"~     By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007~     in §20 SGB V the health insurance schemes have received an enlarged action frame in the~     primary prevention and the operational health support.~      Through these paragraphs arises the possibility for citizens to let refund health-supporting~     programmes or health training of the health insurance schemes.~      Doctor's recommendation is one of the most important predictors by therapy decisions of~     patients.~      At the same time, primary prevention takes a very small part of the working hours of general~     practitioners.~      Hence, is the aim of the present study to examine whether and how general practitioners~     could be incorporated in the mediation of prevention's offers.~      To reach this aim, must be grasped first, to what extent general practitioners are already~     integrated into in the mediation of the primary prevention courses. There is up to now no~     information about whether general practitioners know about the GKV-improved prevention~     programmes for GKV-insured person and whether they are involved in their mediation. This~     research project will close this gap.~      The aims of the study are:~        1. to explore the roll of primary prevention in the general practitioner's consultation~        2. to analyse which social institutions are responsible for primary prevention according~          to the general practitioner's opinion~        3. to explore which primary prevention's programmes do general practitioners in their~          consultation recommend~        4. to analyse which factors play a role in the mediation~        5. to explore whether general practitioners with §20 are familiar.~      This is a mixed methods study which combines a mail survey of all general practitioners in~     Berlin with focus groups of 25 general practitioners.~      In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for~     the focus groups are invited from the pool of teaching doctors of the Institute for General~     Medicine at the Charite.~      After both methods are analyzed on their own, the triangulation of the interpretation of~     both data sets will be done to find possible answers of the study questions.~     Bi-directionality of results will contribute to find possible interpretations of the survey~     responses in the results of the focus group discussions, as well as the results of the focus~     groups discussions could be explained by the results of the survey (Flick).~   "
53903|NCT02351557|"~     This study examines the effect of blood flow through the lungs and the body on the~     consumption and hence requirement of the anesthetic agent isoflurane.~   "
53904|NCT02351544|"~     According to the peripheral trigger theory of migraine headaches, nociceptive inputs from~     irritated or compressed cranial nerve branches can lead to neurovascular changes in the~     brain that cause migraine headaches. Advanced treatments aimed at deactivating the~     peripheral trigger points can be administered to patients who have failed medical management~     of migraines. Those accepted advanced treatments include botulinum toxin A injection in~     order to temporarily paralyze muscles causing nerve compression, and surgery to release~     those compression points permanently. An advantage of surgery is the ability to release~     non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.~      Botulinum toxin A injection into trigger sites has been shown in multiple studies to be~     effective at reducing the frequency and severity of migraine headaches, and is a very~     commonly administered treatment for refractory migraines. It is approved by the FDA for the~     treatment of chronic migraines.~      Similarly, surgical decompression of trigger sites has previously been shown to have~     superior clinical outcomes to medical management, through a randomized, blinded~     controlled-trial performed at Case Western Reserve in 2009. Patients either received actual~     decompression of the trigger sites, or sham surgery (exposure and visualization of the~     trigger sites, without decompression). At one-year follow-up, the group who underwent actual~     surgery demonstrated a statistically higher proportion with significant improvement in their~     migraines (83.7% vs. 57.7%, p=0.014), and with complete elimination of their migraines~     (57.1% vs. 3.8%, p<0.001). Several other reports have confirmed the good clinical outcomes~     of surgery demonstrated in this trial, and surgical decompression is now commonly performed~     by several surgeons around the United States.~      Prognostic factors predicting the success of surgical decompression in migraine headache~     treatment include older age of migraine onset, visual symptoms/aura, and 4-site~     decompression. Factors predicting failure of surgery include excessive operative blood loss,~     and surgery on only one or two trigger sites.~      One criticism of the studies on peripheral trigger decompression surgery for migraines has~     been that most of the results have originated from the same institution (Case Western~     Reserve), and from the same author (Guyuron). While several studies at other institutions~     have demonstrated positive outcomes of peripheral trigger decompression, these have only~     included a small number of patients.~      In addition, the sham surgery randomized-controlled trial has been criticized for not~     clarifying any prior treatments that patients had undergone before peripheral trigger~     deactivation, and for not showing how medication use patterns changed after surgery. Another~     criticism of that study was the fact that patients were examined by neurologists before the~     study but not after the study, and that surgery was performed on some patients with episodic~     migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine~     types are most likely to benefit from surgical decompression.~      The investigators' goal is to perform a multi-center, prospective trial to demonstrate the~     effectiveness of peripheral trigger decompression in the treatment of migraine headaches,~     which would address the criticisms mentioned above. The main aim is to demonstrate that the~     positive results demonstrated by Guyuron et al are reproducible at other institutions and by~     other surgeons using similar techniques on different patient populations.~   "
53905|NCT02351531|"~     The aim of the study is to assess the hypoallergenicity of a new thickened extensively~     hydrolyzed formula.~   "
53906|NCT02351518|"~     Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States,~     resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually.~     Approximately 90,000 of these patients will suffer permanent impairment and more than half~     will experience short-term disability.~      Secondary injury processes play a critical role in the development of ischemia after trauma~     to the central nervous system and occur hours-to-days after the primary insult. Ischemia can~     lead to cerebral infarction or stroke. Ischemia has been described as the single most~     important secondary insult and has been identified histologically in approximately 90% of~     patients who die following closed head injury. Several factors resulting in post-traumatic~     cerebral ischemia have been identified: increased intracranial pressure (ICP), systemic~     arterial hypotension, and cerebral vasospasm. Cerebral vasospasm has been described as a~     sustained arterial narrowing. Clinically, the onset of new or worsening neurological~     symptoms is the most reliable indicator of cerebral vasospasm following a ruptured cerebral~     aneurysm. However, cerebral vasospasm is often unrecognized in patients suffering from~     moderate to severe TBI. These patients frequently have altered mental status due to the~     primary brain injury. In addition, they require narcotics for their pain and paralytics~     and/or sedatives while on a mechanical ventilator for airway protection. Thus, relying on~     the neurological exam to observe deteriorating neurological signs consistent with~     post-traumatic vasospasm (PTV) is reliable. While the etiology and outcome of patients with~     vasospasm secondary to ruptured aneurysm is well documented, the clinical significance of~     PTV after TBI is unknown. A better understanding of the role of cerebral autoregulation in~     the development of cerebral vasospasm could provide the answer. This proposal is for a pilot~     observational study describing the association of the impairment of cerebral autoregulation~     as measured by near infrared spectroscopy (NIRS) with the development of clinically~     significant vasospasm in patients with moderate to severe TBI. The information will serve as~     preliminary data for further study.~   "
53907|NCT02351505|"~     This phase II trial studies how well selinexor work in treating patients with small-cell~     lung cancer that has returned after a period of improvement. One specific way cancer cells~     continue to grow is by getting rid of certain proteins called tumor suppressor proteins:~     that would normally cause cancer cells to die. Selinexor works by trapping tumor~     suppressing proteins within the cell and may cause the cancer cells to die or stop growing.~   "
55730|NCT02327676|"~     This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis~     B patients. Single group of child patients were enrolled, which include HBeAg positive and~     negative Chronic hepatitis B(CHB)group.~   "
53910|NCT02351466|"~     The investigators have previously studied a group of young children with T1D using brain~     MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for~     18 months. The investigators observed significant differences in gray matter volumes and~     white matter microstructure in the children with diabetes as compared to controls. These~     differences appeared to increase over time, with slower rates of brain growth in the T1D~     group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et~     al, Diabetes 2015). In this new protocol the investigators will include the same children~     with T1D and healthy controls previously studied and recruit new similar subjects to replace~     those lost by attrition. The investigators will be using structural and functional brain~     MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the~     brain persist or worsen over longitudinal follow up, and whether these changes are~     associated with measures of glycemic control and neurocognitive metrics as these children~     grow and progress through puberty.~   "
53911|NCT02351453|"~     The primary objective of AID study is to identify the medico-neuropsychological,~     socio-economic and environmental baseline characteristics of dyads associated with the~     institutionalization of AD patients.~   "
53912|NCT02351440|"~     The objective of this study is to determine the effect of preoperative duloxetine on~     postoperative quality of recovery after ambulatory surgery, specifically laparoscopic~     gynecological surgery.~   "
53913|NCT02351427|"~     The purpose of this study is to determine whether bortezomib is effective in the treatment~     of acute cellular rejection after kidney transplantation.~   "
53914|NCT02351414|"~     MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION®~     Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are~     required by regulatory authorities for all devices that do not have medium to long-term~     clinical evidence available at the time of gaining approval to market in the EU. This study~     has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
53915|NCT02351401|"~     Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through~     self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint~     swelling is poor. The objective is to evaluate the use of education by ultrasound feedback~     on the ability of patients to assess for clinical synovitis swollen joints in RA.~   "
53916|NCT02351388|"~     This project will investigate the safety and efficacy of transcranial direct current~     stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease.~     The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's~     disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal~     suppression on right supraorbital area. Active stimulation will be compare to sham condition~     in 20 patients (10 in each groups).~   "
53917|NCT02351375|"~     This study will explore whether the IntelliCap® system can be used to study the human~     microbiota composition in the small intestine. The IntelliCap® system is an oral drug~     delivery and patient monitoring system consisting of a capsule-shaped device and ancillary~     equipment. The IntelliCap® capsule is also able aspirate fluid from its environment. Here,~     we explore whether the capsule is able to take a fluid sample from the lumen of the~     gastrointestinal tract for microbiota analysis. To study this, a controlled dietary~     intervention that is expected to induce a temporary change in microbiota composition will be~     performed in healthy volunteers. Microbiota composition of samples collected from the small~     intestine using the IntelliCap® system will be compared to fecal samples from the same~     individuals collected at the same time point.~   "
53918|NCT02351362|"~     Given there is substantial loss to follow-up soon after delivery among HIV-positive pregnant~     women in South Africa, we will conduct a pilot study of an innovative approach to improve~     retention in care targeted to this specific population at high risk of drop-out. The problem~     of poor retention in care is well documented, but interventions to address the issue are~     lacking. In order to design an effective intervention that will be tested in a future~     randomized controlled trial, we will first complete preliminary research via a pilot study~     in order to determine the feasibility and acceptability of an incentive program (i.e., a~     supermarket voucher) to reduce loss to follow-up among HIV-positive women after delivery.~      The primary objective of this study is to determine the feasibility of a voucher incentive~     intervention aimed at improving retention in postpartum HIV care~      Secondary objectives include: a) to determine the efficacy of the intervention at increasing~     postpartum retention; b) to determine the acceptability of the intervention in terms of~     women's preferences for the intervention compared to other possible interventions; c) to~     assess differences in patient retention among women newly diagnosed with HIV vs. those who~     knew their HIV-positive status before pregnancy; and d) to assess differences in patient~     retention among women who initiated ART during pregnancy vs. those who were on ART before~     becoming pregnant.~      We will enroll up to 200 adult (≥18 years), pregnant, HIV-positive women attending antenatal~     care who have not previously enrolled in the study at Hikhensile Clinic, Johannesburg, South~     Africa. The study will be a prospective intervention cohort study with historical controls.~     Intervention subjects will receive a one-time supermarket voucher of R50 (about $5.00) for~     participants who return for at least one postpartum visit at the study clinic within 10~     weeks of delivery.~   "
53919|NCT02351349|"~     Chronic kidney disease is a common diagnosis in the elderly population and it is associated~     with significant morbidity and health care costs. The prevalence rates increase with age to~     about 40% for adults aged > 65 years. In the elderly population (age 65 and over), CKD is~     associated with a higher burden of comorbid conditions and frailty. The prevalence of~     frailty is higher in CKD patients with rated being double in early stages and nearly 6 times~     higher beyond stage 3b. Previously reported frailty mortality rates of 18% at 3 years and~     47% at 7 years comparing with mortality rates in non frail individuals of 3% and 12%~     respectively. In this study, the investigators investigate the effect of multidisciplinary~     interventions upon frail elderly patients with CKD not yet on dialysis. This interventions~     include best medical care, nutrition, physiotherapy, and social, psychological and spiritual~     support.~   "
53920|NCT02351336|"~     If the investigators could prove that three -dimensional ultrasound measurement of fetal~     adrenal gland volume can accurately predict the likelihood of preterm birth in patients~     having symptoms and signs of PTL , they would be able to use it as a valuable component for~     assessment and early management of high risk pregnant women for PTB which can be positively~     reflected on the risk of neonatal morbidity and mortality in those patients.~   "
53957|NCT02350855|"~     The main aim of the study is to assess the effectiveness of tailored nutritional~     intervention in delaying the progression of cachexia to refractory cachexia in adult female~     cancer patients.~      The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and~     physical activity counselling) for six months, improved the anthropometric and biochemical~     indices in free-living patients suffering from cancer cachexia.~   "
60829|NCT02261025|"~     The aim of present study is to examine the effect of low-dose aspirin on the incidence of~     cardiovascular events and mortality in patients undergoing chronic hemodialysis.~   "
53921|NCT02351323|"~     Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative~     obscurity to become one of the most serious complications of obesity in Hispanic obese~     populations, especially among those with a family history of T2DM. Few therapies have~     demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the~     emerging evidence that glutamine and leucine (building blocks of protein) may affect energy~     partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk~     has been further evaluated in one adult observational cohort study but data on leucine are~     lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to~     reduce insulin resistance, a diabetes risk factor.~      The primary specific aim of the research plan is to conduct a randomized, double-blind,~     placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine~     in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic~     adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history~     of T2DM. At the end of the grant period, we will have obtained preliminary data to plan~     pivotal clinical trials of glutamine coupled with or without lifestyle changes.~   "
53922|NCT02351310|"~     This is a randomized prospective clinical study that will evaluate the effects of antenatal~     corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening~     to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of~     improving composite neonatal mortality and morbidity.~   "
53923|NCT02351297|"~     This study aims at evaluating the consequences of a 3 weeks high protein diet on the large~     intestine ecosystem (microbiota, metabolites and gene expression in rectal mucosa). Those~     parameters will be analysed with technics including OMICs methods. After a run-in period, 42~     volunteers will receive either soy or milk protein or maltodextrin as a placebo control.~     This trial is double blind randomized placebo-controlled paralleled design (3 arms).~     Longitudinal sampling will allow the comparison of parameters during the study.~   "
53924|NCT02351284|"~     To determine the prevalence of hypovitaminosis D in HIV infected patients, and the~     consequences on secondary hyperparathyroidism, and bone mineral density (BMD). Also, to~     establish the improvement in vitamin D status, parathyroid hormone (PTH) and BMD, in case of~     receiving vitamin D supplementation, during a follow up period of at least 1 year.~   "
53925|NCT02351271|"~     The aim of the study is to demonstrate the performance and safety of the Femtosecond~     laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV~     Z8 compared to conventional technique in cataract surgery.~   "
53926|NCT02351258|"~     The overall goal of this Community Central Line Infection Prevention (CCLIP) trial,~     supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to~     determine whether use of a promising new intervention, namely 70% isopropyl alcohol embedded~     protective caps on central lines, in the home setting is associated with a reduction in~     ambulatory central line-associated bloodstream infections (CLABSI) in a high-risk population~     of pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for~     inpatients, it remains unknown what generalizable best practices should be with chronic~     central lines in the home setting and how effective involving patients and caregivers across~     multiple institutions in CLABSI reduction efforts will be. This research will involve a~     cluster-randomized, cross-over design, clinical trial. This proposal will focus on the~     caregivers integral to ambulatory pediatric central line care: patients and families. The~     specific aims of the proposed research program are:~      Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on~     central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology~     patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be~     associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric~     hematology/oncology patients.~      Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on~     central lines reduces the rate of all positive blood cultures in ambulatory pediatric~     hematology/oncology patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be~     associated with at least a 25% reduction in the positive blood culture rate at home for~     pediatric hematology/oncology patients.~      Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps~     on central lines changes the distribution of bacteria isolated from blood cultures of~     pediatric hematology/oncology patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will~     reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood~     cultures at home for pediatric hematology/oncology patients.~   "
53927|NCT02351245|"~     Lip hemangiomas are at higher risk than those located in other sites. However, studies about~     clinical characteristics of lip hemangiomas have not been enough. The investigators want to~     conduct a prospective study on the clinical features of lip hemangiomas.~   "
53928|NCT02351232|"~     A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as~     an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes~     patients in suboptimal glycemic control.~   "
53929|NCT02351219|"~     The study is conducted as a monocentric prospective phase II trial. Patients with~     unresectable stage III locally advanced pancreatic cancer (defined for extended encasement~     of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial~     involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are~     eligible.~      After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided~     for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4~     cycle.~      In case of tumors have deemed resectable surgery is considered. In case tumors remain~     unresectable, radiotherapy is evaluated after the end of chemotherapy.~      Primary objective of the study is the rate of patients who become resectable and undergo~     radical surgical resection after chemotherapy.~      Secondary objectives are: response rate, progression-free survival, overall survival,~     toxicity.~   "
53930|NCT02351206|"~     As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic~     intervertebral disc change in young adults holds high clinical relevance as a common~     structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray~     disc space height measurements as a predictive evaluation method of lumbar disc herniation~     (LDH) and degeneration in LBP patients in their early 20s.~   "
53931|NCT02351193|"~     While practicing the different assisted reproductive techniques, the investigators are faced~     daily by the problem of poor responder females, and the debate about predicting its results~     based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for~     ovarian response, the need to re-assess its role was essential in our community, which led~     us to conduct this prospective multi-center IVF study.~   "
53932|NCT02351180|"~     The purpose of this study is to determine if the use of inhaled beclomethasone after a~     community-acquired respiratory viral infection in a lung transplant recipient decreases the~     risk of the subsequent development of chronic lung allograft dysfunction.~   "
53933|NCT02351167|"~     Our goal is to identify the most appropriate smoking cessation treatments for smokers based~     on genetic information. Smokers try to quit smoking but relapses are common.~   "
53976|NCT02350608|"~     Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU~     the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG.~     The monitoring will continue to the ward for two days. The data will be compared with the~     routine monitoring methods.~   "
53934|NCT02351154|"~     Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover~     if severity AG is present. Sydney system classified AG as mild, moderate and severe, but~     with moderate interobserver agreement, due to this system is based in a visual analogic~     scale (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for~     diagnosis gastric diseases, but when grading AG still remains a qualitative measure.~     Recently, a new software called Cellvizio® Viewer (CV) permits to measure in micrometers~     (µm) the structures observed after confocal laser endomicroscopy probe studies. Based on the~     hypothesis that AG severity is correlated with crypts size diminution, the aim of this study~     is to determine a quantitative way to classify the severity of AG measuring the crypt area~     and inter-crypt spaces in patients with AG.~   "
53935|NCT02351141|"~     The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in~     120 asthma patient volunteers in order to characterize and probe the relationship between~     lung structure and function using imaging.~   "
53936|NCT02351128|"~     The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving~     and/or metastatic MCC in a national prospective multicentre phase II study (centres~     belonging to the skin cancer task force of the French Society of Dermatology namely Groupe~     de Cancérologie Cutanée de la Société Française de Dermatologie). This one-arm study, for~     which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in~     one step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med~     2001, 20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The~     investigators make assumption that a 40% success rate at 3 months would be desirable, but if~     it was 20% or less the treatment would be unacceptable. It gives a trial size of 35 patients~     with a cut-off of 12 patients. Over 12 patients lanreotide will be considered as effective.~      The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will~     be provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on~     somatostatine receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new~     data on this neuroendocrine tumour and potentially provide new therapeutic perspectives.~      The results of this study may :~        -  determine whether somatostatin analogues may help to treat locally advanced and/or~          metastatic MCC;~        -  address whether there is a correlation between positive SPECT-CT (octreoscan)~          assessment and therapeutic response to lanreotide;~        -  evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;~        -  evaluate in future studies, with the ancillary data, other analogues or hybrid~          molecules;~        -  consider, if positive results are obtained from this study, somatostatin analogues as~          adjuvant treatment after surgery of primary MCC.~   "
53937|NCT02351115|"~     The purpose of this study is to determine whether people who usually have photosensitive~     epilepsy will show a reduction in epileptic activity when they take a single dose of~     Staccato Alprazolam as compared to placebo. People with photosensitive epilepsy have changes~     on their electroencephalogram (EEG) when shown flashing lights. Three dose levels of~     Staccato Alprazolam will be compared to placebo.~      This study will also assess the level of sedation of Staccato Alprazolam compared to~     placebo.~   "
53938|NCT02351102|"~     The purpose of this study is to determine whether Valacyclovir treatment, administered~     during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces~     fetal transmission rates and prevents fetal injury in cases of fetal infection.~   "
53939|NCT02351089|"~     The aim of the current Project is to study the efficacy of a probiotic Product in reducing~     the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.~   "
53940|NCT02351076|"~     The aim of the study is to compare correlation for right to left shunts (mainly patent~     foramen ovale) detection for three methods-transesophageal echo as a gold standard,~     transcranial doppler with contrast agent (microbubbles) and new method- Flow detection~     system ( Cardiox TM) in young stoke patients ( age under 55 years).~   "
53941|NCT02351063|"~     HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure.~     B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure.~     Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II~     is to demonstrate that the results of daily patient self-testing of BNP at home will provide~     sufficient information to guide physicians to modify therapy and lower BNP levels over time.~   "
53942|NCT02351050|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis~     (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of~     risk of brain infarctions due to the activation of endogenous fibrinolytic system during~     angioplasty and stenting of coronary arteries. 120 patients indicated for coronary~     angioplasty and stenting will be enrolled into the study in order to demonstrate a~     twenty-percent risk reduction of number and volume of brain infarctions detected using MRI~     examination 24 hours after cardiac endovascular treatment in 5% level of significance.~     Patients will be randomized - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD~     monitoring during endovascular procedure, subgroup 2 will undergo interventions without TCD~     monitoring.~      Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous~     fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of~     the number and volume of brain infarcts, can lead to the increase of the safety these~     patients. We can presume that up to 50% of patients indicated for endovasular heart~     treatment can be treated using these methods in the future.~   "
53943|NCT02351037|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib~     alone or in combination with either cytarabine or azacitidine in the treatment of subjects~     with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without~     prior therapy who refuse standard chemotherapy.~   "
53944|NCT02351024|"~     The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential~     treatment of rheumatic and painful conditions. The study will compare the study drug to an~     already marketed formulation of prescription strength naproxen (Naprosyn® the reference~     product) by looking at how a single dose of the drug is taken up by the body. The safety and~     tolerability of the drug will also be assessed.~   "
53973|NCT02350647|"~     Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX~     Ultra HA, a similar comparative product, for use in the repair of their shoulder injury.~     They will be asked to complete questionnaires throughout the study and will receive an MRI,~     CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony~     ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator~     cuff. The clinical and radiological outcomes will be compared between the study and control~     groups. It is hypothesized that there will be 85% high quality ossification at anchor site~     for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24~     months.~   "
53945|NCT02351011|"~     Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition~     in which the material that cushions the joints, called cartilage, breaks down. This causes~     the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint~     movement. Currently, there are few effective treatments available for patients suffering~     from OA.~      Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which~     means they have the ability to make copies of themselves and to turn into other kinds of~     cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment~     of osteoarthritis, but much of the research is still in the early stages. In this study,~     researchers want to determine the safety of MSCs that a patient can tolerate without causing~     side effects. This will be done by starting at a low dose of MSCs and moving on to the next~     higher dose level provided there are no safety concerns. Researchers will also be looking at~     the function of the knee over time, which may give them some insight on the usefulness of~     MSCs as a treatment option.~   "
53946|NCT02350998|"~     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with~     bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will~     receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the~     middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The~     study is designed to characterize safety and any procedural issues associated with TTT drug~     administration of OTO-201.~   "
53947|NCT02350985|"~     The presented study aims to compare effectivity of propranolol with effectivity of~     venlafaxine in escalating dose in subjects with vestibular migraine (VM) over a period of 12~     weeks. The study population consisted of subjects diagnosed definite VM according to~     criteria of Bárány Society and Migraine Classification Subcommittee of the International~     Headache Society (IHS). Effectivity of therapy was measured by Dizziness Handicap Inventory~     (DHI), number of vertiginous attack of last month and visual analogue scale (VAS) reported~     dizziness related Quality of Life (QOL). Beck Anxiety Inventory (BAI) and Beck Depression~     Inventory (BDI) were also used to determine psychiatric improvement played role in response~     to therapy in venlafaxine treatment arm.~   "
53948|NCT02350972|"~     In patients with multiple metastatic nodules of melanoma, the investigators evaluated~     whether autologous cytokines injected into cutaneous metastases would induce a systemic~     immune response as evidenced by the accumulation of dense lymphocytic infiltrates in~     metastases that had never been injected. Such immune responses were observed, and often the~     never-injected metastasis regressed completely. 20% of patients remained free of disease for~     greater than 5 years.~   "
53949|NCT02350959|"~     The present study is intended to assess the vulnerability of plaques seen on CCTA by means~     of TVC Imaging System and to make comparisons between plaques with adverse plaque~     characteristics and ones without adverse plaque characteristics in terms of plaque volume~     and lipid core contents.~   "
53950|NCT02350946|"~     The purpose of this study is to shed light on the basic neurobiological mechanisms which~     underlie social information processing in healthy men. More specifically, we intend to~     examine whether a person's social competence level is related to the patterns of neural~     activity and his visual search strategies during evaluation of social scenes. Furthermore,~     it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant~     to the task will facilitate social information processing and thus enhance task performance.~     Additionally it will be examined whether oxytocin can facilitate response inhibition in an~     emotional context.~   "
53951|NCT02350933|"~     The purpose of this study is to determine whether possible damages of the trachea caused by~     a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and~     if cuffed tracheal tubes cause less damages than cuffed tubes.~   "
53952|NCT02350920|"~     Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's~     disease and ulcerative colitis. These illnesses often arise at a young age and can be~     associated with significant physical disability. In addition, there is considerable~     psychosocial disability associated with IBD. Previous studies have suggested that simple~     psychological interventions may be valuable in improving quality of life and may even~     improve disease activity. However, there has been no comprehensive trial to determine the~     precise effect of psychological interventions on quality of life (QOL), stress or disease~     activity. Our aim is to conduct a randomised controlled trial of a simple psychological~     intervention to determine it's effect on QOL and stress~   "
53953|NCT02350907|"~     The purpose of this study is to develop a laboratory-based assay that will be a real-time~     PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of~     antimicrobial resistance. This study will also determine factors associated with gonorrhoea~     and describe sexual behaviours of men who have sex with men, to inform parameters for a~     mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.~   "
53954|NCT02350894|"~     This study examines the possible microstructural changes in the brain during recovery after~     mTBI using diffusion MRI.~   "
53955|NCT02350881|"~     Foot silicone implants suffer from bad reputation on the market, due to poor results~     obtained with the first generations of implants. Allergies to silicone, infections due to~     silicone and implants breakage used to be common with previous generations of silicone~     implants. Publications relative to those implants showed that the survival rates after 5~     years of follow-up were unsatisfactory.~      Since 1998, Tornier has been selling a new generation of silicone implants made of~     Ultrasil™. The use of this new material in its manufacturing process together with its~     innovative geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting~     implant.~      The main objective of this study is to evaluate the clinical outcomes of the implantation of~     Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in~     terms of functional metrics from documented clinical data. Other objectives are to evaluate~     the outcomes in terms of radiological evaluation and of safety during all the follow-up.~   "
53956|NCT02350868|"~     The Dose Escalation Phase will determine the MTD of MPT0E028 and evaluate its safety and~     tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation~     Phase will be a cohort expansion at or below the MTD (i.e., an RP2D) of MPT0E028.~   "
53974|NCT02350634|"~     The study is designed to examine the relationship between imaging results detected on a~     18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.~   "
53958|NCT02350842|"~     Cardiac resynchronization is a recommended therapy for patients with advanced heart failure,~     under optimized medical treatment with reduced left ventricular ejection fraction and~     prolonged QRS, nevertheless, still 30% of the population do not respond to standard~     biventricular implantation.~      Non-response can be explained by a combination of factors including sub-optimal patient~     selection, placement of the pacing lead over a zone of slow conduction, insufficient~     correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data~     distinguish true non-responders from patients in which effective resynchronization was not~     delivered through standard biventricular implantation.~      Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has~     been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation~     Therapy) CRT recipients.~   "
53959|NCT02350829|"~     Diffuse fibrosis (or scarring) of the heart muscle is found in a variety of congenital heart~     diseases and in cardiomyopathies (heart muscle disease), and is considered a mediator of~     decreased cardiac function. The detection and quantification of diffuse myocardial fibrosis~     has recently become feasible non-invasively, using cardiac magnetic resonance (CMR),~     applying a new technique labeled T1 mapping. With this technique, the part of the heart~     tissue which is not made up of muscle cells (extracellular volume) can be quantified, as~     long as the individual's hematocrit (cellular volume in the blood) is known. The~     extracellular volume in the heart tissue is regarded as a quantifiable marker for the extent~     of diffuse myocardial fibrosis.~      In the proposed study this new T1 mapping technique shall be applied in patients with~     different forms of congenital heart disease (n=130), cardiomyopathies (n=40) and in control~     subjects (n=30). The additional scan time due to participation in the study will be~     approximately 5-10 minutes, without changing the clinical protocol.~      The main objective is to study the presence and extent of myocardial fibrosis by T1 mapping~     CMR in pediatric patients with congenital heart disease and cardiomyopathies, in comparison~     to cardiovascularly healthy controls.~   "
53960|NCT02350816|"~     This extension study will allow participants to continue receiving treatment with HGT-1410~     and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and~     will evaluate the long-term safety and efficacy of the study drug.~   "
53961|NCT02350803|"~     patients were enrolled by the inclusion criteria and were undergo lefort 1 maxillary~     osteotomy. after the latency phase the distraction was done in anterior- posterior vector.~     patients were divided by randomized allocation in 2 groups. in group 1 the distractor was~     removed after consolation phase, and in group 2 fixation devices were placed immediately~     after removal of distractors. data regarding relapse were analyzed by lateral cephalogram~     X-ray taken in 3 different phases of the trial. change of occlusal plane and the A point~     of the cephalometric analysis were determined as reference point of the study.~   "
53962|NCT02350790|"~     Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned~     to either ablation or excision of endometriosis. The investigators think that patients who~     have excision of endometriosis will have greater relief of pain.~   "
53963|NCT02350777|"~     The purpose of this study is to see if giving the patient stem cells their original donor~     (boost) after removing the T cells (T cell depleted- TCD boost) without further~     chemotherapy. The investigators want to see if this can improve bone marrow function. This~     would also improve the patients white blood counts, red blood counts and platelets. This may~     make the patients chances of improving and surviving better. The investigators will also be~     looking at the short term side effects and risks of the TCD boost.~   "
53964|NCT02350764|"~     The purpose of this study is to closely examine tumor and blood samples from patients~     treated with nivolumab and ipilimumab in order to try to identify why some patients with~     lung cancers respond and why some patients do not.~   "
53965|NCT02350751|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852~     compared to placebo when administered to healthy adult subjects.~   "
53966|NCT02350738|"~     This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for~     people with mild cognitive impairment and early stage dementia by a randomized, controlled~     (mock-therapy), double-blind, cross-over trial~   "
53967|NCT02350725|"~     The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic~     parameters of a novel furosemide formulation administered subcutaneously as compared to oral~     furosemide.~   "
53968|NCT02350712|"~     The purpose of this study is to test a study drug called patritumab. Patritumab may work~     when combined with other medications that are approved in the UK for treating Squamous Cell~     Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is~     hoped that patritumab may have some benefit in treating patients with cancer. This study~     will help identify how much patritumab can be given in combination with cetuximab, and~     cisplatin or carboplatin. This study will also show how safe and how well tolerated~     patritumab is when these medications are given together.~   "
53969|NCT02350699|"~     To use the Nautilus BrainPulse to compare and contrast the signal patterns from this~     cohort's signal patterns with those of concussed high school athletes.~   "
53970|NCT02350686|"~     Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with~     advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.~   "
53971|NCT02350673|"~     This is an open-label, multi-center, Phase Ib clinical study of RO6895882, in combination~     with MPDL3280A, to investigate the safety, pharmacokinetics, and therapeutic activity in~     patients with locally advanced and/or metastatic CEA-positive solid tumors, whose disease~     has progressed on or who are intolerant to the standard of care therapy. Enrolled patients~     who continue treatment will be treated until loss of clinical benefit, unacceptable~     toxicities, or withdrawal of consent. The anticipated treatment period is 24 months for both~     RO6895882 and MPDL3280A and may be modified if emerging data suggest a benefit. The target~     sample size is 75 patients.~   "
53972|NCT02350660|"~     Pilot study to assess the effect of oral immunotherapy on specific IgE levels and antigen~     consumption in two distinct food allergies.~   "
53977|NCT02350595|"~     The potential health effects of high intake of lean or fatty fish will be investigated in~     overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.~      Hypothesis:~      High intake of fatty or lean fish will beneficially affect glucose regulation and the immune~     system.~   "
53978|NCT02350582|"~     Patients with breast cancer undergo a series of psiclofisicas alterations during cancer~     treatment, chemotherapy phase being one of the more aggressive ete effect. These changes~     reduce the quality of life and result in a loss of physical health-related condition.~     Studies have shown that the practice of physical exercise and rehabilitation strategies~     enhance or attenuate the impact of chemotherapy on quality of life of patients. At present,~     technological development from telerehabilitación systems is a promising strategy that~     enables fast and efficient communication between health professionals and patients,~     especially at this stage of the disease where the patient may encounter difficulties in~     matching measures improving their lifestyle with aggressive medical treatment.~      To carry out this study a controlled study masked, parallel-group done were conducted usual~     care control group and an intervention based on a web system telerehabilitación to improve~     the physical condition associated with health and performed quality of life.~   "
53979|NCT02350569|"~     This study will evaluate the safety, tolerability, antiviral efficacy, and pharmacokinetics~     of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 4 weeks in~     adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary~     liver transplantation.~   "
53980|NCT02350556|"~     For several years, the postural disorders assessment in hemiplegic patients was conducted~     through force plate, using the center of plantar pressure displacement in a static position.~      These are widely used in physical therapy both for assessment and rehabilitation of patients~     with balance disorders.~      For hemiplegic patients, an asymmetric distribution support on each foot and an increased~     surface area of postural sways (more marked on the medio lateral axis) are observed.~      These studies, based on the study of plantar pressure ,are not enough to providea full~     description of the spatio-temporal organization of postural components in hemiplegic~     patients.~      Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton~     by considering it as a simple inverted pendulum swinging on his ankles.~      This simplified model can't be used in dynamic assessment because of the simultaneous~     contributions of several joints during movement. This restricts its clinical interest~     because patients are more exposed to imbalances and falls in dynamic situations. Thus, the~     hip angular movement results in a center plantar pressure displacementwhich is impossible to~     discriminate from the ankle axis movement using stabilometric signal only.~      Thus, it seemed interesting to study another variable valid in dynamic conditions : the~     displacement of center of mass during a dynamic balancing task. This variable is obtained~     through 3D motion capture of the different segments of the human body. The dynamic test is a~     dynamic postural assessment following ball avoidance from three different directions. The~     center of mass displacement will be compared with a functional test known to be~     representative of dynamic balance of the individual capacities: The Timed Up and Go test~     (TUG).~      All of this data aims to improve the hemiplegic postural assessment for physical therapy and~     to help develop new rehabilitative approaches.~   "
53981|NCT02350543|"~     This study evaluates the continuation (non-discontinuation) of Aspirin during TURBT. Half of~     participants will continue their usual low-dose Aspirin regimen during TURBT and throughout~     the perioperative period, while the other half will discontinue Aspirin use ten days prior~     to surgery (standard recommendation) and restart therapy two weeks post-discharge.~   "
53982|NCT02350530|"~     BACKGROUND:~      For patients with liver-limited metastatic colorectal cancer (mCRC), complete resection of~     liver metastases is the only potentially curative treatment. The current goal of medical~     treatment for colorectal cancer with initially unresectable liver metastases is to maximize~     the rate of secondary resection and prolong overall survival (OS). A strong correlation was~     found between response rate and secondary resection rate of metastases, and the triple drugs~     combination of infusional 5-fluorouracil/leucovorin (5-FU/LV), irinotecan, and oxaliplatin~     (FOLFOXIRI) was recommended can be used in selected patients with potentially resectable~     metastases in order to improve response rate and make resection more possible. The addition~     of a anti-VEGFs monoclonal antibody such as bevacizumab to chemotherapy has been shown to~     increase response rate, resection rate and improve OS in the first-line treatment of mCRC~     patients. The efficacy and safety of bevacizumab in addition to triplet drugs were~     previously tested in OLIVIA trial, the resection rate of liver metastases of 49% was~     reported, and the response rate was 81%; most common grade 3-4 adverse events was~     neutropenia. On the basis of such promising results, we conducted the present randomized~     study to explore whether FOLFOXIRI plus bevacizumab compared with FOLFOXIRI alone as~     first-line treatment could improve radical resectability in patients with RAS mutation-type,~     unresectable liver-only metastatic colorectal cancer.~      OBJECTIVE:~      The primary objective of the FOBULM study is to evaluate the efficacy of FOLFOXIRI plus~     bevacizumab compared to FOLFOXIRI alone in patients with initially unresectable~     liver-limited RAS mutation-type mCRC.~      Secondary objectives are safety and tolerability of the treatment, efficacy in terms of~     objective response rate (ORR), OS, progression free survival (PFS), quality of life and an~     assessment of biomarkers for predictive response and prognosis.~   "
53983|NCT02350517|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined~     with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or~     metastatic esophageal squamous cell cancer.~   "
53984|NCT02350504|"~     MRI has been recognized for many years as the safest and the most precise imaging method,~     particularly for children. However, the accuracy of MRI demands from the patient to avoid~     any movement while the examination is in process. This task is accomplished with difficulty~     by children and requires the assistance of an anesthetizing staff. In this research, our~     main goal is to investigate an introductory instruction as an assistive tool in performing~     MRI without the need in anesthesia.~   "
53985|NCT02350491|"~     Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in~     osteoarticular destruction and serious disability. When clinical symptoms (painful and~     swollen joints) occur, the innate and adaptive immune responses against self antigens have~     already been largely amplified. This might explain that even when RA patients are treated~     very early and aggressively, a remission of the disease can only be obtained in~     approximately half of them. This proportion of remission under treatment can only be~     achieved using treat to target strategies involving biologics, such as anti-TNF.~     Unfortunately, less than 20% of patients remain in remission after treatment~     discontinuation. Thus, despite the availability of 5 different types of biologics, there are~     still therapeutic unmet needs. However, a spontaneous, drug-free decrease of disease~     activity can be observed in a physiological condition, pregnancy. Although most of~     treatments of RA have to be discontinued during pregnancy, a marked improvement, and~     sometimes remission, can be observed during pregnancy, with frequent post-partum flares. The~     situation is the opposite with an increased risk of flares in systemic lupus erythematosus~     (SLE), a rare systemic autoimmune disease which generally progresses in flares-up and can~     affect nearly any organ (the skin, joints, kidneys, the brain, the heart, …). The course of~     the disease remains unpredictable for a given patient, and very few biomarkers are available~     to help clinicians to identify patients a risk of flares. Thus, safe therapeutic options~     remain limited, especially in patients with serious complications. A specific concern in SLE~     is the fact that the disease usually starts in women entering their sexual and reproductive~     life. Even with a stable condition (i.e : lupus without recent flares and no impaired renal~     or cardiac function) as it is medically recommended before getting pregnant, up to 40% of~     SLE patients flare up during pregnancy.~      We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those~     regarding the pattern and levels of microRNAs, could explain the clinical improvement and~     the risk of flares in RA and SLE, respectively. A better understanding of the underlying~     mechanisms could help to identify new biomarkers, notably those predicting flares in SLE,~     and therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in~     RA and targeting them in SLE.~   "
53986|NCT02350478|"~     This study is planned to evaluate if linagliptin can improve endothelial function in~     patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine~     bioavailability ratios and postchallenge glycaemic control will be studied.~   "
53987|NCT02350465|"~     The objectives of this study are to: 1) validate a rapid, portable, cost-effective method~     for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a~     novel approach to progressive resistance exercise involving eccentric muscle actions that~     will counter the local effects of myosteatosis and sarcopenia in African Americans.~   "
53988|NCT02350452|"~     Endometriosis is a benign chronic gynaecological disease that affects 10% of women of~     reproductive age and takes 40% of them to assisted reproduction techniques.~      The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular~     count (AFC) , with the most common serological markers of ovarian reserve. The investigators~     intend to confirm their clinical utility in the assessment of ovarian function, and to~     promote their use in predicting decreased ovarian reserve.~      The work therefore moreover arises the objective to validate the bibliographic data about~     using the laser for haemostasis after stripping endometriomas, to amplify knowledge~     available in the literature on the surgical treatment of ovarian endometriomas and on the~     diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH~     levels and the possible surgical implications on fertility .~   "
53989|NCT02350439|"~     Fractional flow reserve (FFR) is an established invasive method for assessing the~     physiological significance of coronary artery stenosis. However, in recent studies it has~     been observed and reported some degree of variation in the fraction of the coronary artery~     to the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose~     (140mg/kg/min). The observed variation may be attributed to a failure to achieve maximal~     hyperemia with the normal dose. The administration of adenosine at a higher dose (200μg/kg~     /min) may influence coronary flow reserve (FFR) eliminating Pd / Pa variation during~     adenosine infusion.~      This is a prospective study which will be conducted in patients after coronary angiography~     with at least one angiographic lesion ≥50% in coronary vessels.~      Patients after written consent will undergo assessment of lesion severity with FFR under a~     three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia~     (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g.~     difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with~     three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per~     3 beats will be offline analyzed. The FFR during steady hyperemia state is defined as the~     average of the minimum ratio Pd / Pa per three beats.~   "
53990|NCT02350426|"~     This is an adaptive Positron Emission Tomography/ Computed Tomography (PET/CT) and Dynamic~     Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) open-label study design for the~     investigation of inflammation in adult rheumatoid arthritis (RA) patients, not involving~     therapeutic intervention. Each study participant will undergo two half body PET/CT scans~     from the pelvis to the bottom of the feet (including hands and wrists) with an additional~     bed position centred on the shoulders. One scan will be conducted with 18F-FDG and the other~     with 18F-GE-180. The first PET/CT scan (PET1) will be performed 4 weeks (28 +/- 2 days)~     after the first screening visit, whereas the second PET/CT scan (PET2) will be carried out~     within 2 weeks (7 +/- 7 days) after PET1. The order of PET/CT scans for each subject will be~     based on a computer generated randomisation schedule after the screening visit. A sub-group~     of study participants will be invited to undergo an additional dynamic 18F-GE-180 PET scan~     of a selected joint (knee or wrist) prior to their 18F-GE-180 PET/CT half body scan. The~     primary objective of the study is to quantify inflammation in joints of RA patients by~     determining 18F-FDG and 18F-GE-180 uptake using PET, and DCE-MRI parameters.~   "
53991|NCT02350413|"~     The experience of the chronic illness negatively engraves on the quality of life of~     patients. Endometriosis is a disease that affects millions of women of childbearing age; it~     has repercussions on psychological health, as shown by numerous recent studies.~      The aim of the present study is to validate the italian version of EPH 30, a self reported~     questionnaire, already used internationally, in order to determine the quality of life in~     women with endometriosis, assess their psychological health and the effectiveness of~     therapies.~   "
53992|NCT02350400|"~     Background~      Hepatic metastases of colorectal cancer (MCC) is quite common and is a major source of~     morbidity and mortality. There has been evidence to show that hepatic arterial~     chemoembolisation using DC beads (drug eluting beads, 100-300μm) loaded with irinotecan~     (DEBIRI) showed improved overall survival when compared to systemic therapy (FOLFIRI), but~     being larger they have their limitations.~      New 70-150μm beads are recently available and currently there is limited data concerning its~     use. Safety of these beads have not been tested in local patients.~      Hypothesis / Aim To study the safety and pharmacokinetics of the smaller 70-150μm DEBIRI in~     a pilot study of 5 patients. The smaller 70-150μm beads will be able to deliver a more~     consistent and higher dose to tumoral tissue with a smaller systemic dose. Being smaller and~     less embolic, it will also be better tolerated. Patients will also be genotyped for their~     UGT1A1*28 and UGT1A1*6 polymorphism status as the latter genotypes are associated with~     decreased clearance of irinotecan and SN-38 in Asian patients.~      Methods Single centre, pilot study, prospectively recruiting 5 patients with unilobar~     disease, refractory to systemic chemotherapy~      The primary endpoints:~        1. establish safety and toxicity profile of the irinotecan loaded DEBIRI beads~        2. establish pharmacokinetics and systemic exposure of irinotecan and its active~          metabolite, SN-38.~      The secondary outcome measurements:~        1. the incidence and severity of adverse events, liver function parameters and laboratory~          abnormalities;~        2. response rate,~        3. progression free survival~        4. overall survival~      Clinical Significance~      This treatment modality has the advantage of directly delivering irinotecan to the liver~     metastases from colorectal cancer. This local mode of drug delivery may result in a higher~     intratumoral drug concentration and rapid tumour shrinkage leading to downstaging of the~     hepatic metastatic lesions. These therapeutic outcomes may also downstage patients to~     hepatic resection.~   "
53993|NCT02350387|"~     The purpose of this study is to determine if there are differences in balance, strength,~     functional performance and self-reported outcomes for subjects with knee osteoarthritis who~     complete a low intensity, long duration eccentric training program compared to those who~     complete a high intensity, short duration eccentric training program. This study will be~     utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all~     eccentric exercise.~   "
53994|NCT02350374|"~     The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic~     response in children and adolescents with type 1 diabetes. Carbohydrate counting is a~     technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal.~     Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend~     to improve. Carbohydrate counting is a recommended technique in the adult diabetic~     population. There is little data on the use of this methode in youth with diabetes. There~     are no studies on the change of carbohydrates content at meals in children and adolescents~     with diabetes practicing counting carbs, while it is the main interest of this technique.~     The aim of this study is to assess how children and adolescents with type 1 diabetes use the~     possibility to change their carbohydrate amount at each main meal when they use the counting~     carb method. The investigators hypothesize that children vary their amount of CHO greatly.~     This is an argument for using this technique in pediatrics~   "
60925|NCT02259777|"~     Study to investigate the effect of food intake on the bioavailability of a fixed dose~     combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast~   "
53998|NCT02350322|"~     The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a~     schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance~     (concentration and learning abilities), mental health statua and markers of nutritional~     status. In addition, to disentangle the effect of fatty fish eaten as food and the effects~     of omega-3 fatty acids taken as a supplement.~   "
53999|NCT02350309|"~     This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage~     strengths of E2006 (5 mg and 10 mg) in subjects with insomnia disorder.~   "
54000|NCT02350296|"~     The present bioequivalence phase I study is needed to compare the bioavailability and the~     concentration-time profile of the new immediate release formulation of KLS 40 mg with the~     reference compound OKi®, ketoprofen lysine salt 80 mg granules for oral solution (bipartite~     sachets).~      The objective of the study is to investigate the bioequivalence between two formulations~     containing ketoprofen lysine salt (KLS) when administered as single oral dose in two~     consecutive study periods to healthy male and female volunteers under fasting conditions.~   "
54001|NCT02350283|"~     To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute~     stroke within 12 hours of symptom onset.~   "
54002|NCT02350270|"~     The main objective of the GOOD initiative was to determine which spatio-temporal gait~     parameters and/or combination(s) of spatio-temporal gait parameters best differentiate~     between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI)~     and those with mild and moderate dementia.~   "
54003|NCT02350257|"~     The primary objective of this study is to test the effectiveness of internet-delivered and~     therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety~     disorders (including social anxiety disorder, separation anxiety disorder, generalized~     anxiety disorder, panic disorder and specific phobia) in a randomized trial where~     participants will be allocated to either ICBT or to a supportive control condition.~     Non-responders (defined as those participants who still uphold their primary anxiety~     disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT.~     Follow-ups are conducted at 3 and 12 months after treatment completion.~   "
54004|NCT02350244|"~     Evaluate the benefit of an intervention by a computer program comprising active breaks, in~     the form of a personalized self-program on functional impairment and / or pain, among~     employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in~     connection with the computer work environment.~   "
54005|NCT02350231|"~     Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of~     these multiple births being twin births . Preterm birth defined as birth occurring prior to~     37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in~     the United States.~      Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are~     at increased risk of developing respiratory distress syndrome, sepsis, intraventricular~     hemorrhage, and necrotizing enterocolitis.~      Twin pregnancy is considered one of the important risk factors of preterm birth. Over~     distension of uterus may be one of the etiological factors for preterm birth. However, no~     definite effective interventions have been shown to prevent preterm delivery in twin~     pregnancy.~      Three large randomized trials suggested that progesterone might prevent preterm delivery in~     high-risk singleton pregnancy especially those with previous preterm delivery or short~     cervix might be reduced by antenatal progesterone.~      Fonseca et al (2007) concluded that women with short cervix are less likely to deliver~     preterm ≤34 weeks if they are treated with vaginal progesterone.~   "
54006|NCT02350218|"~     The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared~     to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST~     levels followed by Eglandin administration were assessed.~   "
54007|NCT02350205|"~     This clinical trial is designed to assess the safety, effectiveness and benefits of Self~     Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of~     full-thickness burn wounds that require permanent coverage where the availability of donor~     sites is limited.~   "
54008|NCT02350192|"~     Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational~     programs have been proved to be effective support to CVD clients. However, most e-health~     programs lack personalization and this seldom results in exercise behavioral change.~     Considering the advantages of e-health programs, as well as the widespread internet use and~     the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized~     Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health~     educational intervention versus usual care for middle aged cardiac vascular (CV) patients on~     their total physical exercise, exercise adherence and quality of life.~   "
54009|NCT02350179|"~     The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss~     during and after elective C.S.~      The Research Question Is Tranexamic acid effective in reducing blood loss during and after~     elective Caesarean section?~      The Research Hypothesis The TXA could be able to reduce blood loss during and after elective~     Caesarean section.~      The null hypothesis will therefore state that:~      There will be no difference between TXA and placebo in reducing blood loss during and after~     elective Caesarean section.~   "
54022|NCT02350010|"~     There were lack of data and analysis about medical management, etiology, and long-term~     outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do~     acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk~     factors of ICH. Further the investigators will aim to develop and validate a risk score for~     predicting 1-year functional outcome after ICH.~   "
54046|NCT02349685|"~     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter~     pylori (H. pylori) therapies has been declined coincidently. In this study, the~     investigators evaluated the efficacy of H. pylori eradication between a personalized therapy~     for H. pylori infection based on the results of antibiotics resistance by using H. pylori~     culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens,~     and the investigators analyzed the prevalence of the antibiotic resistance after 1st~     eradication of H. pylori in the tailored therapy group.~   "
54192|NCT02347774|"~     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational~     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease~     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)~     guidelines.~   "
54010|NCT02350166|"~     Surgical resection is still recommended as the optional treatment for colorectal liver~     metastasis (CLM) patients. There are two main concerns for resectable colorectal liver~     metastasis which remain controversial: surgical time and surgical type. As for the former,~     synchronous resection of primary colorectal tumor and liver metastasis, with the reason of~     fare overall survival rate and absence of a second surgery, has gained wide population from~     gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to~     surgical type, Open liver resection is the optimum choice for CLM patients no matter what~     the metastasis profile is. And for management of primary tumor, laparoscopic procedure is~     mature in surgical skill and has been evidenced equivalent overall survival rate compared~     with open resection. So, primary colorectal tumor resection could be either open or~     laparoscopic procedure. Therefore, the investigators team conducted the controlled trial to~     compare two surgical procedures in treatment of resectable colorectal liver metastasis.~     Patients will be randomly assigned into conventional laparotomy group for simultaneously~     resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted~     small-incision group for resection of laparoscopic colorectal tumor combined with~     synchronously small-incision open resection of liver metastasis. The aim of this trial is to~     observing short-term operative effects after surgeries.~   "
54011|NCT02350153|"~     The purpose of this study is to study since 1987 all patients diagnosed with CD in Sweden~     and determine their outcomes including mortality. A secondary objective is to focus on~     patients in remission and identify determinants of their different outcomes.~   "
54012|NCT02350140|"~     Early accurate diagnosis is one of the first crucial steps in care for infants born to~     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early~     diagnosis and results in significant reductions in infant morbidity and mortality. The~     investigators recently concluded a successful randomized controlled trial in Kenya entitled,~     Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV~     transmission (PMTCT): a randomized trial of a text messaging intervention~     (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a~     behavioral theoretical framework significantly improved maternal attendance at post-partum~     clinic appointments and rates of testing to facilitate early infant diagnosis of HIV in a~     selected population and controlled setting. Understanding the effectiveness of this~     intervention (and its limitations) in a real-world, routine-care setting represents the next~     step in the translational pathway to public health impact. The investigators therefore now~     propose a cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan~     Ministry of Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption,~     Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the~     text messaging to improve testing (TextIT) intervention. Our specific aims are:~        1. To determine the effect of TextIT on maternal attendance at postpartum clinic visits~          during the randomized stepped-wedge rollout of the intervention.~           Hypothesis 1: A greater proportion of women at health facilities implementing TextIT~          will attend clinic within eight weeks postpartum compared to women at health facilities~          implementing standard care.~        2. To determine the effect of TextIT on virological infant HIV testing within eight weeks~          after birth during the randomized stepped-wedge rollout of the intervention.~           Hypothesis 2: Infants of women at health facilities implementing TextIT will be more~          likely to have virological HIV testing compared to infants of women at health~          facilities implementing standard care.~        3. To determine the costs and cost-effectiveness of TextIT. The investigators will~          estimate the cost per patient and per health gain achieved (disability-adjusted life~          year, DALY) comparing TextIT to current standard care.~      Hypothesis 3: The TextIT intervention will be more cost-effective than current standard~     care.~   "
54013|NCT02350127|"~     Nearly 1 in 10 older Veterans have dementia, which is a devastating condition that leads to~     a progressive loss of independence and functional status. Currently available dementia~     medications do not alter the disease course. Therefore, it is critically important to~     identify effective strategies for helping older Veterans living with dementia to enhance~     their functional status and quality of life. The investigators have developed a novel,~     integrative exercise program called Preventing Loss of Independence through Exercise (PLIE)~     that incorporates elements from Eastern and Western exercise modalities and is designed to~     build and maintain the capacity to perform basic functional movements while increasing~     mindful body awareness and enhancing social connection. Pilot study results suggest that~     PLIE is associated with meaningful improvements in physical function, cognitive function and~     quality of life as well as reduced caregiver burden. The goal of the current study is to~     perform a full-scale randomized, controlled trial to test the efficacy of PLIE in older~     Veterans with dementia.~   "
54014|NCT02350114|"~     This is an observational study of the functional capacity of patients with Heart failure~     with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical~     treatment.~   "
54015|NCT02350101|"~     In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was~     introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.~      Goal of this retrospective study is to evaluate the influence of this algorithm on~     coagulation, use of blood products, coagulation factors and ROTEM evolution.~   "
54016|NCT02350088|"~     To evaluate the safety and efficacy of Hirschsprung's disease~   "
54017|NCT02350075|"~     The aim of this study is to determine the clinical success of short implants (6mm) alone and~     standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.~   "
54018|NCT02350062|"~     Different neuromuscular monitors may be available in the same care structure. Two different~     monitors are available in the investigators' institution in the operative room and the~     recovery room. However, these two monitors have not been compared and may not be~     interchangeable. Starting the monitoring with one device and continuing with another device~     may be inaccurate and may lead to inadequate medical decisions. The investigators therefore~     conducted this observational study to compare the two devices available in our institution.~   "
54019|NCT02350049|"~     The purpose of this study is to evaluate the safety and effectiveness of the Cementless~     Oxford Partial Knee System.~   "
54020|NCT02350036|"~     50 pregnant females were divided in two groups, twenty five as a control group and twenty~     five as high risk group; they were subjected to uterine artery Doppler, measurement of~     maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14~     weeks of gestation, all pregnancies were followed until 40 weeks for development of~     pre-eclampsia~   "
54021|NCT02350023|"~     Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical~     corticosteroids are the established agents for treating this disorder. There are several~     case reports and case series which have demonstrated the efficacy of topical prostaglandins.~     The two agents have not been compared head-to-head in the published literature. The~     investigators attempt to compare the efficacy and safety of topical betamethasone and~     topical latanoprost in the treatment of localised alopecia areata.~   "
54045|NCT02349698|"~     The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen~     receptor T cells and to determine the proper dosage of CAR T cells infused.~   "
60926|NCT02259764|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL~   "
54023|NCT02349997|"~     Fluid retention in the legs due to chronic heart failure (CHF) during the daytime may~     redistribute to neck when with supine positioning at night. A portion of the shifted fluid~     accumulates in the neck, and narrows the upper airway, predisposing the patient to~     obstructive sleep apnea (OSA) and central sleep apnea (CSA). However, the mechanism of~     overnight fluid shift on OSA and CSA remains unclear. The investigators pre-experiment~     demonstrated there may be a different mechanism of overnight fluid shift on OSA and CSA. The~     accumulation of water content in neck soft tissue increases neck circumference and leads to~     pharyngeal resistance, upper airway collapse and causes OSA. The effect of nocturnal fluid~     shift on CSA may be because of increasing of chemosensitivity (fluctuation of PaCO2),~     circulation delay and hemodynamic disordered. This study is aimed to explore the different~     mechanism of overnight fluid shift on OSA and CSA by comparing the changes of upper airway~     (inside diameter, water content, and pharyngeal resistance), PaCO2, circulation delay~     (lung-to-finger circulation time) and hemodynamic (loop gain).~   "
54024|NCT02349971|"~     This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid~     Osteoma lesions in children and young adults.~   "
54025|NCT02349958|"~     To determine treatment response to surgical debulking and intra-operative Intraperitoneal~     Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:~      Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical~     cancers).~      Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon,~     appendix).~      To monitor the toxicities and complications of this treatment regimen. To measure treatment~     related QOL changes after IPHC.~   "
54026|NCT02349945|"~     CONDITION: Idiopathic male infertility In men with idiopathic infertility, the sperm DNA~     fragmentation index (DFI) within 12 weeks of FSH therapy and 12 weeks follow-up improves~     depending on the FSHR genotype as assessed by the non-synonymous SNP rs6166 (wild type or~     p.N680S).~      This is a phase II b, multicenter, prospective, open label, one arm, clinical trial~     stratified according to the patient's genotype.~      INTERVENTION: FSH therapy (150 I.U. sc every other day for 12 weeks) in infertile men who~     are homozygous for the wild-type FSHR or the p.N680S allele of the FSHR. Duration of~     intervention per patient: 12 weeks~      Primary efficacy endpoint: Sperm DFI. Number of patients with an improvement in DFI > 60%~     Key secondary endpoint(s): pregnancy, semen parameters, serum levels of inhibin B and AMH.~   "
54027|NCT02349932|"~     A person's blood type is defined by the types of sugars they express on their red blood~     cells, with antibodies being made to non-self sugars and excluding blood cells expressing~     these sugars (the basis of blood transfusion reactions). These same sugars can be expressed~     by commensal bacteria in our gut lumens. The investigators hypothesize that a person's~     antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria~     in our guts. Supporting our hypothesis, a person's blood type correlates with the overall~     composition of their gut flora. Because these sugars are also used by certain pathogens to~     initiate infection, this information could directly inform our understanding of host~     susceptibility to various infectious organisms.~   "
54028|NCT02349919|"~     The purpose of this study is to investigate the effectiveness of oral procaterol in~     treatment of non-asthmatic patients who suffer from persistent cough following upper~     respiratory tract infection (URTI).~   "
54029|NCT02349906|"~     The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan~     compared to the conventional (myeloablative) dose of i.v. Busulfan, each administered as~     part of a standardised Fludarabine-containing conditioning regimen and to contribute to a PK~     model which permits - in conjunction with data comparing Treosulfan and Busulfan in adults~     with malignant diseases - to extend the use of Treosulfan in the paediatric population by~     extrapolating efficacy.~   "
54030|NCT02349893|"~     The United States is currently experiencing an increase in the incidence and prevalence of~     obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the~     population, untreated OSA has been implicated in increased risk for cardiovascular disease,~     including hypertension and heart failure, daytime sleepiness, and increased risk of motor~     vehicle accidents.~      This study was design in order to evaluate the CelonProSleep plus for multi-level~     radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to~     moderate obstructive sleep apnea syndrome (OSAS).~   "
54031|NCT02349880|"~     Shared decision-making is being promoted as a promising approach for engaging patients~     with schizophrenia in medical decisions and improving satisfaction and adherence.~      To implement shared decision-making, both physicians and patients should commit to it and~     engage in a mutual decision process. Most research, however, has addressed interventions~     that either focus on the doctors' side (e.g. communication skills) or on informing~     patients about treatment options (e.g. decision aids). These approaches have been shown to~     be feasible in clinical practice but had no strong effects on treatment patterns or~     adherence, possibly because they were insufficient to motivate and enable patients to engage~     actively in decision-making. Moreover, these interventions still rely on the doctor's~     willingness to share decisions, which has been shown to vary considerably.~      To overcome these limitations and since many patients do not feel competent to participate~     in decision-making we developed an intervention that focuses on patients' communicative~     competencies. this intervention, a five session group-training, will be implemented for~     inpatients suffering from schizophrenia.~   "
54032|NCT02349867|"~     This is a phase 1 study of concurrent chemoradiation using a regimen of sorafenib and~     vorinostat with gemcitabine and radiation following chemotherapy in patients with pancreatic~     cancer to find the RP2D of the concurrent chemoradiation combination. A traditional 3+3~     dose-escalation design will be conducted for the sorafenib and vorinostat dose escalation.~     Adenocarcinoma of the pancreas without distant metastasis that has been treated with ≥ 1~     prior therapy (not including radiation) encompassing at least 2 months. Adequate~     hematologic, hepatic, and renal function. Ability to take oral medication. To determine the~     doses and schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent~     gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer~     following chemotherapy.~   "
54075|NCT02349308|"~     The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO~     catheter, during intermittent dialysis over a period of 6 months after placement.~   "
54076|NCT02349295|"~     The main purpose of this study is to evaluate how effective and safe the study drug known as~     ixekizumab is in participants with active psoriatic arthritis.~   "
54033|NCT02349854|"~     Seborrheic dermatitis is a common, inflammatory skin condition that causes flaky, white to~     yellowish scales to form on oily areas such as the scalp or inside the ear. These scales can~     occur with or without underlying reddened skin. In addition to causing psychological~     distress, low self esteem, and embarrassment, seborrheic dermatitis is associated with scalp~     pruritus (itch). Treatment modalities exist to control scalp flaking and itch associated~     with seborrheic dermatitis, although such therapies often lose efficacy over time. As~     seborrheic dermatitis is a chronic (life-long) condition, better treatments are needed. The~     investigators propose to better characterize in subjects with seborrheic dermatitis~     involving the scalp versus normal scalp controls: (a) the clinical characteristics of the~     associated itch and (b) the pattern of nerve innervation to the scalp. In this way, the~     investigators hope to get a comprehensive understanding of the factors causing scalp itch~     with the aim that this information will create new candidates to which treatment modalities~     can be designed. At least 12 (up to 20) subjects and similar number of control subjects~     without disease will have one clinic visit including questionnaires, testing of sensation on~     the scalp, and biopsy of the scalp.~   "
54034|NCT02349841|"~     To evaluate the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics~     of meropenem administered intravenously three times a day, plus amoxycillin/CA administered~     orally three times a day; and of faropenem administered orally three times a day, plus~     amoxycillin/CA administered orally three times a day; for 14 consecutive days, in adult~     participants with newly diagnosed, smear positive pulmonary tuberculosis, in order to help~     establish proof-of-concept for carbapenem antibiotics as antituberculosis agents and to~     select the appropriate agent and route of administration for later stage clinical~     development.~   "
54035|NCT02349828|"~     A prospective, randomized trial to calculate incidence of Herpes Simplex Virus in an~     in-patient burn population and determine efficacy of prophylactic antiviral therapy to~     prevent viral infection and/or reactivation. Hypothesis is that antiviral prophylaxis will~     be effective in reducing HSV infection/reactivation.~   "
54036|NCT02349815|"~     -  To describe characteristics (demographic, clinical, social) of first time users of~          Jaydess.~        -  To estimate the duration of use of Jaydess.~        -  To study switching patterns, e.g. what are the hormonal contraceptive methods used~          before and what are the methods after discontinuing Jaydess.~        -  To study off-label use of Jaydess~   "
54037|NCT02349802|"~     Phase I study to determine the device-related injection failure rate of the single-use,~     pre-filled autoinjector.~   "
54038|NCT02349789|"~     Gait and balance disturbances are one of the most incapacitating symptoms of Parkinson's~     disease (PD) (Boonstra et al. 2008). They can cause falls and are therefore associated with~     the negative spiral of (near) falls, fear of falling, fractures, reduced mobility and social~     isolation; hence, having a profound negative impact on quality of life (Lin et al. 2012).~     Originally, symptoms of PD were ascribed to dopamine deficiency and basal ganglia~     dysfunction (Wu et al. 2013). However, in the last decades it has become clear that other~     brain structures are also involved in the pathophysiology of PD (Snijders et al. 2011;~     Stefani et al. 2007). An intriguing, emerging insight is that the cerebellum may be involved~     in the pathophysiology of PD (Wu et al. 2013). That is, the cerebellum is hyperactive in PD~     patients during different motor tasks (Yu et al. 2007; Hanakawa et al. 1999; del Olmo et al.~     2006). However, whether cerebellar hyperactivity is pathological or compensatory and how it~     affects gait and balance in PD patients remain open questions. Here, the investigators aim~     to elucidate the role of the hyperactive cerebellum in gait dysfunction in PD patients by~     modulating cerebellar excitability with state-of-the-art non-invasive brain stimulation~     techniques and investigate the effects on gait.~   "
54039|NCT02349776|"~     Allograft transplants are offered to people with haematological cancers sometimes as the~     best chance of a cure. However, the survival rates for these procedures can be quite poor,~     as the transplant, in itself, can be lifethreatening.~      In addition, these procedures usually involve a period of lengthy hospitalisation~     accompanied by a host of debilitating conditions which patients must cope with in isolation~     due to their increased risk of serious infection. Perhaps unsurprisingly, there is~     considerable evidence that mood plays a role in the way people recover.~      I wish to investigate the psychological impact of providing testimonies from survivors of~     transplants to patients undergoing the procedure.~      The plan is initially to collect about 10-15 testimonials from past transplant patients~     using a videotaped structured interview then to collate these testimonials into a booklet~     format and DVD.~      This booklet and DVD would be used as an intervention where 40 consecutive patients who are~     going ahead for transplant are invited to receive the testimonial intervention.~      Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test~     (LOT), and a questionnaire about expectations of treatment in clinic once a decision to~     proceed to transplant has been made. Patients will receive the testimonies upon admittance~     to the transplant unit and then receive the HADS and a structured interview within the first~     week of being admitted to the transplant ward (just prior to receiving the transplant) and~     within the first two weeks following the transplant.~      Comparative analyses of the measures between the three time points would be performed and~     qualitative analysis of the structured interview data.~      Around 80 people undergo transplant each year, it is estimated that the project will be~     completed by September 2016. The intention would be to publish following completion.~   "
54040|NCT02349763|"~     Comparison of the efficacy and side effects of intravenous and oral regimens of~     dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary~     ovarian, fallopian tube and peritoneal cancer patients receiving first cycle of combination~     paclitaxel and carboplatin.~   "
54041|NCT02349750|"~     The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate~     for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150~     IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of~     hCG was injected intramuscularly. Patients were randomly allocated into two equal groups:~     Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and~     after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound~     and patients had failed trial underwent another trial of IUI for a maximum of three trials.~   "
54042|NCT02349737|"~     Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA)~     and implantable cardioverter defibrillators (ICDs).~   "
54043|NCT02349724|"~     The main purpose of this research is to verify the safety of CEA targeted chimeric antigen~     receptor T cells and to determine the proper dosage of CAR T cells infused.~   "
54044|NCT02349711|"~     In this randomized, double-blind, placebo-controlled study, participants with seasonal~     allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess~     health-related quality of life, stress, physical activity, gastrointestinal symptoms,~     adverse events, and compliance. In a subset of subjects, stool and blood samples will be~     collected at baseline and at week 6 of the intervention (estimated to be peak allergy~     season) to characterize microbial communities and immune function.~   "
54047|NCT02349672|"~     Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic~     asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature~     newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to~     25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral~     palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant~     financial impact on the health care system. In the state of Florida, the total cost for~     initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take~     into account the life-long costs.~      Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia~     treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance~     imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in~     identifying non-responders to hypothermia. MRI requires transport of the neonate with a~     requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the~     amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in~     these patients to assess candidates and predict outcomes prior to hypothermia, can be~     adversely affected by hypothermia itself and the patient may not appear to improve until~     re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid~     biochemical test is essential to identify candidates for therapeutic hypothermia, to~     distinguish responders from non-responders and to assess outcome. This research is the first~     step needed to treat neonates with HIE employing a personalized medical approach using serum~     proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic~     hypothermia. These biomarkers will aid in the direct care by providing a rapid test to~     predict outcomes and select candidates who are likely to benefit from therapeutic~     hypothermia and gauge a response to the neuroprotective intervention.~   "
54048|NCT02349659|"~     24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing~     Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM.~     Subject population is chronic inguinal pain refractory to previous surgical intervention~     (neurectomy).~   "
54049|NCT02349646|"~     10-SMI-2012 is a post market observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     peripheral neuropathy~   "
54050|NCT02349633|"~     Phase 1: The Phase 1 study is an open label, multi center, multiple dose, non randomized,~     safety, pharmacokinetic, and pharmacodynamics dose escalation study of PF 06747775 as a~     single agent in patients with advanced EGFRm NSCLC (del19 or L858R, +/ -T790M).~      Phase 2: an open label, multi-center, single arm study of PF-06747775 for the assessment of~     anti-tumor activity in patients with advanced EGFRm (del19 or L858R) advanced NSCLC with~     T790M (del 19 and T790M or L858R and T790M) and further pharmacokinetic characterization.~   "
54051|NCT02349620|"~     The main objective of this clinical trial study is to consider the effect of~     Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental~     implants.~   "
54052|NCT02349607|"~     This study will examine the activity of PF-05089771 and pregabalin, alone and in combination~     on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in~     healthy male subjects~   "
54053|NCT02349594|"~     To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production~     and other relevant immune functions. A soybean oil emulsion, rich in the omega-6~     polyunsaturated fatty acid linoleic acid, will serve as control.~   "
54054|NCT02349581|"~     This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain~     after breast cancer surgery.~   "
54055|NCT02349568|"~     Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the~     diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost~     effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in~     previous studies. The aim of our study was to assess the cost effectiveness of EUS based~     strategy versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate~     risks for CBD stones in a real working situation in a developing country.~   "
54056|NCT02349555|"~     This open label study seeks to study the effects of a nutritional supplement on inflammatory~     markers, metabolic parameters, and safety in subjects compared to baseline after taking~     supplement for 2 and 4 months.~   "
54057|NCT02349542|"~     The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine~     in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the~     use of a standardized periarticular injection containing free bupivacaine and liposomal~     bupivacaine.~   "
54058|NCT02349529|"~     Children and young people with epilepsy are at increased risk of poorer outcomes related to~     emotional and psychological adjustment, peer relationship problems, lower academic~     attainment and mental health problems across the lifespan. Despite the well understood~     risks, there continues to be a lack of psychological and psychosocial support for young~     people with epilepsy, and a corresponding lack of evidence regarding the effectiveness of~     psychosocial interventions. This study aims to evaluate a manualised psychosocial group~     intervention for adolescents with epilepsy. A cognitive behaviour therapy approach is used,~     aimed at increasing awareness of how epilepsy may impact upon thoughts, feelings and~     activities and to develop strategies for improved psychological adjustment. In addition, an~     epilepsy knowledge component aimed at improving a sense of control and epilepsy~     self-management is included. A group delivery format allows an opportunity for social~     modelling, and social problem solving, helping others and relating to other young people~     with similar experiences. The social learning context and availability of knowledgable~     facilitators (an epilepsy nurse specialist and clinical psychologist) are also key aspects~     of the intervention. The study will allow us to establish a standard manualised group~     intervention that can be used throughout the UK which aims to; establish the effectiveness~     and desirability of this approach; improve the overall quality of life, psychological health~     and social integration of young people with epilepsy; and to improve epilepsy knowledge and~     selfmanagement skills aimed at maximising seizure control and overall management.~   "
54059|NCT02349516|"~     A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in~     combination with Ranibizumab intravitreal injections in patients with diabetic macular~     edema. The study duration is 52 weeks and patients will be randomized to one of four~     treatment arms.~   "
54060|NCT02349503|"~     This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with~     congenital adrenal hyperplasia (CAH). The study will be conducted in approximately 15~     adolescent females (12-18 years of age) with a documented medical diagnosis of classic~     21-hydroxylase deficiency CAH. The study will include three independent dose cohorts of~     NBI-77860 (approximately 5 subjects per dose cohort). Ascending doses will be evaluated as~     part of a sequential-cohort design.~   "
54061|NCT02349490|"~     Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact~     (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human~     intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding~     site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal~     is applied after an initial failure of the institutional standard method. Homeostatic~     success is determined by 5 min without bleeding at gastrointestinal site. after application~     of Seraseal.~   "
54062|NCT02349477|"~     This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol~     dependence will get medication, which might help them to reduce or stop their drinking, or a~     placebo ( placebo is a capsule that looks the same as the investigational drug, but has no~     real medication. It is a sugar pill).~   "
54063|NCT02349464|"~     The purpose of this study is to determine whether a post-hospital discharge lactation~     support system increases preterm infant intake of mother's milk.~   "
54064|NCT02349451|"~     This study is a Phase 2 randomized, double-blind, double-dummy, active- and~     placebo-controlled, parallel-group study designed to assess the safety, tolerability,~     efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in subjects with~     active psoriatic arthritis (PsA) who are inadequately responding to methotrexate (MTX)~     treatment.~   "
54065|NCT02349438|"~     This study will test the feasibility that differences in contact lens wettability can be~     measured with a wavefront sensor.~   "
54066|NCT02349425|"~     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of AF-219~     in subjects with Refractory Chronic Cough.~   "
54067|NCT02349412|"~     The study intervention consists of the early integration of palliative care services into~     standard oncology care in an outpatient setting for patients with advanced lung and~     non-colorectal gastrointestinal malignancies who are not being treated with curative intent.~     The palliative care services provided to patients randomized to the intervention will be~     provided by board-certified physicians and/or advanced practice nurses and will focus on the~     following areas: (1) developing and maintaining the therapeutic relationship with the~     patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing~     support and reinforcement of coping with advanced cancer in patients and family caregivers;~     (4) assessing and enhancing prognostic awareness and illness understanding in patients and~     family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care~     planning.~   "
54068|NCT02349399|"~     The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol~     (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics,~     previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne~     treatment and (concomitant) use of hormonal contraceptives identified in Healthcare~     Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).~   "
54069|NCT02349386|"~     The objective of this clinical study is to evaluate the safety and efficacy of three~     different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the~     maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate~     cancer.~   "
54070|NCT02349373|"~     Running is a natural part of human locomotion and humans have been running for million of~     years. In modern society, running has become a popular way of exercise and is undertaken by~     many people worldwide, possibly because it provides a cheap and easily accessible form of~     exercise, and the positive effects of running on health and fitness are well known.~     Unfortunately, running is also associated with a high risk of injury.~      The purpose of this project is to investigate how a running schedule which focuses either on~     running distance or running speed influence the overall risk of injury and the types of~     injury sustained in recreational runners.~   "
54071|NCT02349360|"~     The purpose of this research study is to determine the effects of the probiotic,~     Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria~     and blood biomarkers in healthy individuals.~   "
54072|NCT02349347|"~     The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in~     combination with a transplant of patients' own blood stem cells for a maximum of three~     cycles.~      In a recently completed small Phase I study looking at the use of higher doses of~     intravenous Melphalan with the combination of lenograstim (a drug that stimulates bone~     marrow to produce white blood cells helping to fight infection) and patients' own blood~     infusion over 4 cycles of treatment has proved encouraging. The results of this study showed~     rapid improvement in pain and a fall in circulating tumour cells within two weeks of~     starting Melphalan. However, slow platelet recovery after the fourth cycle meant longer~     periods of platelet transfusion. For this trial we intend to assess the efficacy of an~     intensified intravenous Melphalan with transplant of patients' own blood stem cells over a~     shorter time period. This study will involve approximately 39 patients over a 3 year period.~   "
54073|NCT02349334|"~     Faecal incontinence occurs when a person passes faeces (stools) without the usual control.~     It is a distressing condition that is actually very common although under-reported because~     of embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs~     and bowel retraining, but many patients still resort to surgery to improve symptoms.~     Although several operations exist to treat incontinence e.g. those aiming to repair damaged~     anal sphincter muscles, it is now clear that these often have poor results.~      Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial~     nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the~     bowel and muscles of the anus (anal sphincter).~      SNS does this by inserting electrodes in the lower back just above the tailbone and~     connecting them to an implanted electrical stimulator which is buried in the buttock and~     acts a bit like a heart pacemaker. SNS is a relatively well-established treatment in~     specialist centres, which has been used for over 10 years. It has been shown in studies to~     be successful for faecal incontinence achieving some improvement in at least three quarters~     of patients. In Europe, this procedure is fast becoming first treatment offered when~     non-surgical treatments fail. Nevertheless, SNS is not a miracle cure for all, requiring 2~     operations, with potential complications and expensive equipment (> £10,000 approx).~      PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle,~     using a very small needle, as an outpatient (a bit like acupuncture). This sends signals~     back to the spine region to try and improve symptoms of faecal incontinence. Since this is a~     newer treatment, fewer studies have been performed to quantify how successful it is, but~     early results of PTNS suggest that it may be as good as SNS. If this is true, this is very~     important because it is much less invasive and considerably cheaper than SNS (equipment £500~     per patient).~      This project will for the first time determine how effective PTNS is in the treatment of~     patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is~     a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres..~     The results of this trial will lead to direct benefits for patients and the NHS.~   "
54074|NCT02349321|"~     Development and evaluation of a multi-faceted school-based intervention to prevent intimate~     partner violence among Grade 8 high school students in South Africa~   "
54077|NCT02349282|"~     In an ageing population, the need for interventions to help older people remain healthy,~     active and independent for as long as possible, increases. Although several studies suggest~     a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical~     functioning, particularly in vulnerable populations, results are contradicting. Randomized,~     placebo-controlled trials are needed to further establish the effect of vitamin D on muscle~     strength in the frail elderly population.The primary aim of this study is to determine the~     effect of daily supplementation with two different forms of vitamin D on muscle strength in~     frail elderly people over a period of 24 weeks.~   "
54078|NCT02349269|"~     The aim of the investigators trial was to evaluate association between new onset~     postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.~   "
54079|NCT02349256|"~     The study uses in depth interviews to understand their experience of somatoform disorder,~     possible explanations and their experience of somatoform disorder, possible explanations and~     their understanding of treatments, especially their ideas about psychosocial treatments.~   "
54080|NCT02349243|"~     This is a randomized, controlled, double blind clinical trial. The purpose of this study is~     to investigate the weight loss efficacy of entacapone. In this study, participants are~     randomly divided into entacapone and placebo groups. The percentage change in body weight,~     the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat,~     serum insulin, serum triglyceride and the adverse effects are compared between the two~     groups.~   "
54081|NCT02349230|"~     Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control -~     received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment -~     received Astym® treatment to the lower extremity. Subjects were blinded to whether they~     received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on~     a lower body ergometer the subjects were familiarized to the operations of a computerized~     leg press machine that measured the maximum force output (Newtons) during a unilateral~     isometric squat test. A baseline measure of maximal force output (pre-test) was determined~     by the average of 3 trials with a 30 second rest period between the trials. The subjects~     then received the designated treatment intervention. Immediately following the treatment~     intervention (0 minutes following treatment intervention) the subjects were retested~     (post-test) using identical testing procedures by an investigator blinded to the treatment~     intervention received by the subject. Maximum force output measured in Newtons for the~     post-test was subtracted from the maximum force output (Newtons) pre-test and then converted~     to a percentage of change [(post-test - pretest)/pretest X 100). The percent change of~     maximal force output from pre-test to post-test measures was compared using a one-way~     analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined~     statistical differences between the groups.~   "
54082|NCT02349217|"~     The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention~     on relationship satisfaction with quality of life and immune system function among breast~     cancer survivors and their partners.~   "
54083|NCT02349204|"~     Music is commonly heard in operating room. The goal of this study is to measure the effect~     of music on surgical performance using a intraocular surgery simulator. The music chosen is~     Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the~     simulator, both with and without music, in a randomized sequence. The results will be~     subtracted from the simulator and analyzed.~   "
54084|NCT02349191|"~     This study is a prospective, single arm, non-randomized, interventional study to evaluate~     the safety and effectiveness of Omental transposition (OT) in subjects with early stage AD.~      Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to~     baseline.~      The following assessments will be performed at baseline, then at 1, 3, 6, 12, and 24 months~     following surgery:~        -  Montreal Cognitive Assessment (MoCA)~        -  Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog)~        -  General Practitioner Assessment of Cognition (GPCOG)~        -  Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) Subjects who~          have early stage AD confirmed by a neuropsychological test (MoCA) and who are healthy~          enough to undergo surgery.~      The experimental procedure to be performed is omental transposition (OT) surgery. It will be~     performed as a laparoscopic or open procedure for omental lengthening and an open procedure~     for brain access, with a general surgeon performing the omental lengthening/tunneling and a~     neurosurgeon performing brain access/brain biopsy/omental placement on brain.~      Up to twenty-five (25) subjects, with the first 5 subjects being part of a learning curve~     group and the next 20 subjects being part of the experimental group.~      The duration of each subject's participation will be approximately 25 months from screening~     through the 24 month follow-up visit.~   "
54085|NCT02349178|"~     This is a Phase 2 study designed for the purpose of estimating various parameters~     surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating~     minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without~     causing significant delay of HCT due to treatment related toxicity.~      A single course of bridge chemotherapy is given prior to the transplant procedure as an~     approach to improved disease-free survival in a patient group who historically has had~     inferior outcomes.~   "
54086|NCT02349165|"~     The gold standard corneal crosslinking (CXL) technique involves the initial step of~     epithelial removal, in order to achieve a sufficient treatment effect (meaning:~     stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of~     transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is~     instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after~     which standard CXL is performed. This solution seems to facilitate riboflavin penetration~     into the corneal stroma through the intact epithelium. The investigators expect to achieve a~     similar effect of TE-CXL with the advantage of a faster healing time and less risk of~     infections.~   "
54087|NCT02349152|"~     This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery~     to supress the hyperglycemic response in perioperative period. Half of the participants will~     receive continuous intravenous remifentanil during surgery, while the other half will~     receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl~     administration is this institution's standard of care.~   "
57016|NCT02310802|"~     The primary objective of this study is to assess the increase in clinical pregnancy rate~     after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist,~     compared to placebo.~   "
54088|NCT02349139|"~     This study will be conducted in three parts. Part A is a dose-escalation study to determine~     two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate~     cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the~     ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified~     in Part A to determine which one is more effective, and collect additional pharmacokinetic~     data. Part C is an extension for subjects completing either Part A or B.~   "
54089|NCT02349126|"~     Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or~     tenofovir and be evaluated for safety and efficacy.~   "
54090|NCT02349113|"~     This study is being done to study age-related bone changes in women. The investigators know~     that the major cause of osteoporosis is a shortage of the female hormone estrogen. This~     study will look closer at how this shortage of estrogen works to cause a decrease in bone~     formation.~   "
54091|NCT02349100|"~     To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does~     uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false~     positive PET imaging?~   "
54092|NCT02349087|"~     In Kuopio University Hospital Department of Clinical Neurophysiology there have been~     designed a fast EEG electrode, that is suitable for acute emergency use. This study will~     address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients~     who have been resuscitated due to cardiac arest. After resuscitation patients will be~     treated in ICU and EEG will be recorded for 24 hours.~   "
54093|NCT02349074|"~     Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among~     the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest~     shock.~      The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in~     digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal~     damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions~     of GI tract and their potential involvement in the post-CA shock is therefore unknown.~      We propose an original clinical research program aimed at rigorously determining the~     incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of~     post-CA shock through a prospective, interventional, multicentric study~   "
54094|NCT02349061|"~     The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a~     reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus~     (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,~     kidney problems, and anemia, among other problems).~   "
54095|NCT02349048|"~     The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen~     containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not~     having received treatment with any approved or investigational drug) participants with~     chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early~     stages of liver fibrosis or with cirrhosis.~   "
54096|NCT02349035|"~     The purpose of this study is to improve prosthesis control for transradial amputees with~     combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.~   "
54097|NCT02349022|"~     The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT~     with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate~     cancer pre-prostatectomy as confirmed by pathology.~      Individuals participating in this study will have a [111In]-capromab pendetide scan, as well~     as a PET scan following the injection of [89Zr]-Df-IAB2M.~   "
54098|NCT02349009|"~     1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment~     period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and~     COMP) for the modified Rodnan skin score (MRSS). Study subjects will be randomized to apply~     the active study medication daily for 4 weeks to either the right or left forearm and~     placebo to the contralateral forearm.~   "
54099|NCT02348996|"~     Adequate control of extracellular volume is a major goal of renal replacement therapy in~     patients with chronic renal disease. Fluid overload is present in the early stages of~     chronic kidney disease and contributes significantly to hypertension, arteriosclerosis and~     high prevalence of left ventricular hypertrophy. These are associated with high rates of~     morbidity and mortality in this group of patients, rates on dialysis in Brazil is around17.9~     % per year. Dry weight during hemodialysis remains a delicate gap between hypervolemia and~     hypovolemic. Many studies have shown that tight control of post - dialysis weight is related~     to better outcomes in short term and higher long-term survival. Many methods have been~     proposed for estimating the hydration status of hemodialysis patients in an objective~     manner, including ultrasonography of the inferior vena cava and echocardiography. However,~     these methods are very time-consuming and cumbersome to use in daily practice. In most~     dialysis centers, the dry weight is evaluated on subjective clinical criteria, with trial~     and error and time consuming. It was recently introduced in Brazil to monitor body~     composition by multifrequency bioimpedance, called Body Composition Monitor ( BCM )~     manufactured by Fresenius Medical Care. The BCM is a piece of bioimpedance spectrometry~     using a three compartment model, able to quantify objectively and accurately the~     extracellular volume and hydration status of each patient by measuring body resistance to an~     electric current. The procedure is safe, simple and relatively inexpensive. The BCM uses~     multi-frequency currents (ranging from 5 to 1000 KHz ). The availability of this device~     evaluation of body composition which assesses the dry weight more efficiently and~     objectively determine a target to be achieved to prevent left ventricular hypertrophy,~     hypertension better manage and improve cardiovascular outcomes, motivates us to perform this~     study. So the goal is to compare the efficacy between bioelectrical impedance analysis and~     clinical evaluation for suitability of dry weight in hemodialysis patients. A prospective,~     randomized, crossover study, which will include all chronic renal failure patients on~     hemodialysis at St. Luke 's Hospital (PUC - RS), including patients with at least three~     months on HD and over 18 years of age. The expected primary outcome is to achieve greater~     accuracy in determining the state of hydration and dry weight of these patients.~   "
54114|NCT02348801|"~     Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle~     program while continuing usual treatment for diabetes. The lifestyle program will consist of~     teaching how to practice healthy diet and regular exercise at our facility and continued~     into the community and home. It is hoped that the results would provide convincing proof~     about the usefulness of lifestyle change in older patients with diabetes.~   "
54137|NCT02348502|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be~     the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and~     the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon~     treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring~     good long term outcomes in patients with chronic hepatitis B. it was not clear whether~     patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained~     viral response and the state of HBsAg level≤100 IU/ml.~   "
54100|NCT02348983|"~     Being obese can be a risk factor for many health problems, including high cholesterol, high~     blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to~     our economy, face challenges that put them at increased likelihood of being obese. The~     investigators want to come up with a program to help drivers get to a healthy weight and~     stay there.~      The WHEEL pilot study is a 12 week weight loss intervention in long-haul commercial truck~     drivers. The study involves two visits to the University of Utah's Rocky Mountain Center for~     Occupational and Environmental Health, one at the start of the study and a second one at the~     end of the study. Both visits include a general health history questionnaire, a 24-hour diet~     recall questionnaire, anthropometric measurements, as well as an assessment of blood~     pressure, hemoglobin A1c, and a cholesterol and lipid panel. Each truck driver is assigned a~     health coach who helps the driver create and achieve three health goals.~      The health coach works with the driver to set individualized goals specific to weight loss,~     and contacts the driver weekly to check in and tweak goals as needed.~      Drivers are also compensated for their participation in the study and get to keep all of the~     intervention materials that the investigators give them. All that the researchers ask is~     that they try their best to have a healthier lifestyle and give us feedback on what they~     liked and didn't like in the study.~   "
54101|NCT02348970|"~     To evaluate the efficacy (non-inferiority) in terms of response between patients using~     custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom~     made devices TALI, after 2 months of use. Sleeping tests were performed.~   "
54102|NCT02348957|"~     CML requires ongoing treatment and assessment of treatment milestones in order to manage the~     disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and~     CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to~     prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented~     efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on~     how CML is managed in real-life clinical practice settings. Therefore this~     non-interventional study is designed to collect real-life data on CML-treatment with~     Dasatinib in clinical routine with respect to first and second line treatment and/or switch~     setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on~     health care provided in registered doctor's practices as here most of CML patients who are~     not involved in clinical trials are treated.~   "
54103|NCT02348944|"~     The purposes of the study are to assess intra individual biological variability of serum and~     urinary cartilage specific biomarkers and define the best standardized conditions for blood~     and urine sampling in the frame of biomarkers dosage.~   "
54104|NCT02348931|"~     Investigation of the effect of customized nasal braces in the correction of nasal~     deformities with and without prior corrective surgery.~        -  Trial with medicinal product~   "
54105|NCT02348918|"~     A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical trial Designed to~     Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin®~     and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema~   "
54106|NCT02348905|"~     ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis~   "
54107|NCT02348892|"~     The large share of chronic diseases correlated with an aging population calls to develop~     necessary coordination between the hospital and non-hospital (professional of the city, home~     ...) to create new complementarities.~      Since July 2013, the Nantes University Hospital experiences the establishment of a~     coordinator route patient in Gerontology. The evaluation program of the benefit of~     coordinating the course in elderly patients in health establishment (PROCOPES) must allow to~     prove the efficiency of the intervention of a coordinator route patient, following elderly~     patients in complex situations, both within the hospital and outside the hospital (home,~     nursing home,...). The objective of PROCOPES is to show the added value of an innovative~     position that can make the link between the hospital and the city on deemed complex~     situations.The pilot study results present a strong interest for health care settings,~     nursing home and in the world of research. It will also permit to have preliminary data for~     bigest studies.~   "
54108|NCT02348879|"~     This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study~     consists of a 21 day screening period followed by administration of the investigational~     product and up to 154 day evaluation period.~   "
54109|NCT02348866|"~     This study will determine if there is a difference in bacterial contamination (CFU/cm2)~     between obstetric resident surgical scrubs donned at home and those donned at the hospital.~   "
54110|NCT02348853|"~     U.S. Army Medical Research & Materiel Command Telemedicine and Advanced Technology Research~     Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a~     randomized trial comparing two different interventions for sustainable weight loss.~     Specifically, the investigators will compare a current best practice(CBP) intervention~     that includes standard dietary advice with a new, Healthy Weight for Living (HWL)~     intervention that includes recommendations to eat a diet rich in protein, dietary fiber, low~     glycemic index carbohydrates and low calorie foods. The objective of this study is to~     compare the CBP and HWL interventions when delivered to adult dependents of active duty (AD)~     military personnel and measure weight loss effects in both the adult dependents and the AD~     military personnel they live with.~   "
54111|NCT02348840|"~     The purpose of the study is to explore ways to improve maternal and child outcomes in the~     ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities~     in health care access and outcomes when compared to other inhabitants of Guatemala who are~     not ethnically Maya and live in other parts of the country.~   "
54112|NCT02348827|"~     The aim of the present study is to compare an intervention consisting of Family~     Psychoeducation (FPE) to an active control intervention of social support for relatives of~     patients with a diagnosis of major depression.~   "
54113|NCT02348814|"~     The overall aim of this study is to validate a quantitative digital tool for staging liver~     fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in~     patients.~   "
54138|NCT02348489|"~     To compare efficacy and safety between SGI-110 and Treatment Choice in adults with~     previously untreated AML who are not considered candidates for intensive remission induction~     chemotherapy.~   "
60927|NCT02259751|"~     Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483~   "
54115|NCT02348788|"~     Both artemether-lumefantrine and chloroquine are currently used and recommended by Malaysian~     Ministry of Health as blood stage treatments for non-severe P. vivax and P. knowlesi~     malaria. Microscopic misdiagnosis between Plasmodium species remains a large issue in Sabah,~     Malaysia and elsewhere. In order to facilitate potential policy change to a unified ACT~     guideline for all malaria species in Sabah artemether-lumefantrine needs to be evaluated for~     P. vivax malaria.~      Preliminary data in a recently completed RCT evaluating artesunate-mefloquine vs chloroquine~     for P. vivax showed up to 36% P. vivax recurrence with chloroquine monotherapy by day 28~     post treatment without primaquine. Based on these data blood stage chloroquine treatment~     failure rates should also be evaluated in the context of standard concurrent (rather than~     delayed) liver stage primaquine dosing, due to both its potential blood stage synergistic~     effect in addition to known decreased recurrence rates. As artemether-lumefantrine is one of~     the current first line Ministry of Health ACTs used in Sabah with a lower adverse event~     profile compared to artesunate-mefloquine, this was recommended as the more appropriate ACT~     to evaluate against chloroquine.~   "
54116|NCT02348775|"~     We have recently reported that older patients with HIV are deficient in glutathione (GSH)~     due to decreased availability of cysteine and glycine, and that oral supplementation with~     cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and~     improves (but does not fully normalize) concentrations of red-cell GSH. We also found that~     when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved~     with an increase in intracellular GSH concentrations. These older HIV patients also had~     significant increases in muscle strength with improvement of GSH levels.The current proposal~     in older HIV patients will investigate study if cysteine and glycine supplementation for a~     duration of 12 weeks will result in changes in : (a) GSH levels; (b) body~     composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial~     energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and~     glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months,~     GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests~     will be measured for a further 2 months to determine the effects of washout.~   "
54117|NCT02348762|"~     The investigators have previously reported that older patients with HIV are deficient in~     glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral~     supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their~     own levels, and improves concentrations of red-cell GSH. The investigators also found that~     when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an~     increase in intracellular GSH concentrations. The current proposal will investigate if~     cysteine and glycine supplementation for a duration of 24 weeks will result in changes in :~     (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality~     of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and~     oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months~     after completing supplementation, measurement of GSH concentrations, strength, function,~     mitochondrial energetics and neurocognitive tests will be done to determine the effects of~     washout.~   "
54118|NCT02348749|"~     The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl~     Guanidine) behaves in the body after injection, how it spreads to all the organs and how it~     is removed from the body. We will also study how long 18F-MFBG lasts in the blood after~     administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a~     PET-CT scan.~   "
54119|NCT02348736|"~     A randomized controlled prospective study of laryngoscopy and intubation time comparing~     SensaScope and the McGrath® Series 5 video laryngoscope.~   "
54120|NCT02348723|"~     The primary objective of this trial is to assess the safety of an uninterrupted dabigatran~     etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen~     in NVAF patients undergoing AF ablation in a PROBE (Prospective, randomized, open label,~     blinded end point) active controlled study.~      Secondary objectives are to assess additional safety endpoints and efficacy in this clinical~     setting.~      It is not intended to assess confirmatory hypothesis, this is an exploratory study.~   "
54121|NCT02348710|"~     This randomized controlled trial will test a multicomponent intervention to increase~     exercise Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions~     and levels of exercise. Sixty early stage breast cancer survivors will be recruited from the~     Duke Cancer Institute. Participants will be randomized to the exercise OE intervention or an~     attention control group. Both groups will receive the American Cancer Society diet and~     exercise guidelines and an accelerometer. The intervention group will also receive an OE~     workbook containing self-directed activities to increase OEs by focusing on OE importance~     (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur);~     and accessibility (frequency with which the outcome(s) are thought of). The attention~     control group will receive a workbook containing the same activities focused on diet, rather~     than exercise.~   "
54122|NCT02348697|"~     Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and~     adolescent patients with full thickness cartilage defects after the treatment with NOVOCART~     3D.~   "
54123|NCT02348684|"~     The association between radiation exposure and cardiac disease is well recognized, it is not~     fully understood if there exists an optimal or safe radiation dose-volume relationship.~   "
54124|NCT02348671|"~     The purpose of this study is to investigate if wound dressings are capable in reducing the~     effects of shear- force at the skin. With our own shear- force model we are able to apply 19~     Newton shear- force combined with 9 newton pressure at the skin of the non- dominant~     forearm. After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow~     (Laser doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect~     of shear- force application at the skin.~      Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant~     fore-arm but this time we put a wound dressing between the skin and shear- force model.~     After half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and~     the erythema index.~      This research consists of three research day, each day we are going to investigate a~     different wound dressing~   "
54125|NCT02348658|"~     This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of~     single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.~   "
54126|NCT02348645|"~     The purpose of this study is to assess the feasibility of a full-scale multicenter~     randomized, controlled trial comparing the effectiveness of two surgical treatments for a~     condition associated with lumbar spinal stenosis called degenerative lumbar~     spondylolisthesis. Both treatments are currently used, but individual surgeons use different~     selection criteria for each treatment and use the procedures at different rates. The two~     procedures are decompression with fusion (the most common surgical procedure for~     spondylolisthesis) and midline-sparing decompression alone (which is also a standard~     treatment, but is not as widely used for treating spondylolisthesis). The investigators plan~     to collect the evidence on the following:~        1. The feasibility of the trial protocol, and~        2. Preliminary data on the effectiveness of each treatment.~   "
54127|NCT02348632|"~     This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of~     JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05~     201, or ADX-N05 202.~   "
54128|NCT02348619|"~     This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter~     study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult~     subjects with OSA.~   "
54129|NCT02348606|"~     This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm~     parallel group study of safety and efficacy of JZP-110 in the treatment of excessive~     sleepiness in adult subjects with OSA.~   "
54130|NCT02348593|"~     This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,~     4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of~     excessive sleepiness in adult subjects with narcolepsy.~   "
54131|NCT02348580|"~     The study uses experimental methods to evaluate the effectiveness of an educational~     intervention in Rwanda. The intervention, designed by Aflatoun and AMIR, involves training~     teachers on the use of active-learning methods to implement a social and financial education~     curriculum with students in primary and secondary schools. Teachers then implement the~     social and financial curriculum with students in order to improve their personal, social,~     and financial competencies.~      Teacher training will take place in November-December 2013 and the curriculum implementation~     will be evaluated in the 2014 school year.~      The study will examine the following hypotheses:~        1. Did teachers use of active learning methods in class increase due to the training~          received?~        2. Did students' levels of engagement and on-task behaviour increase as a result of the~          intervention's pedagogy and content?~        3. Did the following competencies of students improve due to the intervention?~             1. Self-efficacy~             2. Social skills~             3. Financial literacy~             4. Planning attitudes~             5. Savings attitudes~             6. Savings behavior~             7. Entrepreneurship~        4. Did the intervention change student's pass rates on the primary six (P6) and secondary~          three (S3) final examinations for the classes in which it was implemented?~        5. Did the intervention change student drop out rates in the classes which it was~          implemented?~   "
54132|NCT02348567|"~     Introduction: Accreditation programmes for healthcare systems have been implemented in more~     than 70 countries to stimulate high-quality organisational performance. Several Danish~     healthcare institutions are covered by the Danish Healthcare Quality Programme (DDKM) and~     all Danish public hospitals have been accredited according to the DDKM since 2010.~      The dates of each survey are currently being announced 8-10 months beforehand. Announcing~     surveys has been criticised for creating an arranged reality. It has therefore been~     suggested that a national intervention be conducted to evaluate the effect of unannounced~     hospital surveys.~      Methods and analysis: All public somatic and psychiatric hospitals in Denmark (n=30) were~     invited to participate in the trial. Twenty-three hospitals (77%) (3 university hospitals, 5~     psychiatric hospitals, and 15 general hospitals) agreed to participate and to be randomised~     to one of the trial clusters. Eleven hospitals will receive announced surveys (control~     group) and 12 hospitals will receive unannounced surveys (intervention group).We hypothesise~     that hospitals receiving unannounced surveys will be rated as less successful than hospitals~     receiving announced surveys, defined as meeting less compliance with accreditation standards~     and performance indicators. Nine experienced surveyors employed and educated by The Danish~     Institute for Quality and Accreditation in Health Care (IKAS) will be responsible for~     conducting the surveys according to an abbreviated version of the current Danish periodic~     survey. The outcome is compliance with indicators reflecting organisational performance.~     Compliance will be analysed using logistic or linear regression analysis with random~     effects, contingency tables, and Pearson's chi-squared test or Fishers exact test, whichever~     is most appropriate.~      Ethics and Dissemination: This trial is pending ethics approval from Research Ethichs Comite~     for North Denmark Region. The findings from this randomised controlled trial will be~     disseminated through peer-reviewed journals, national and international conferences and will~     be utilised as health care political decision making for the future national accreditation~     programme. In addition, the results will facilitate to validate the effect of unannounced~     hospital surveys; given the issues of currently meeting an arranged reality during~     hospital surveys, this seems extremely desirable.~   "
54133|NCT02348554|"~     The aim of this study was to validate functions for estimating energy expenditure in~     controlled and free-living conditions. This method was based on accelerometry data acquired~     from smartphones worn in a trouser pocket. The developed functions have been compared to the~     estimations provided by three research devices named Fitmate, Armband and Actiheart.~   "
54134|NCT02348541|"~     Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.~   "
54135|NCT02348528|"~     CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide~     plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who~     participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd~     treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide~     treatment for subjects who have shown therapeutic benefit.~   "
54136|NCT02348515|"~     Recent evidence of a potential role for cardiac progenitor cells (CPCs) in cardiac repair~     and the discovery of a vasoprotective axis of the renin-angiotensin system (RAS) offer such~     breakthroughs. Investigators have observed that an imbalance in the vasoprotective axis~     {angiotensin converting enzyme 2 (ACE2)/angiotensin-(1-7) [Ang-(1-7)]/Mas receptor} and the~     vasodeleterious axis [angiotensin converting enzyme (ACE)/angiotensin II (AngII)/AngII type~     1 receptor (AT1R)] of the RAS within the CPCs affects their functionality and regenerative~     potential. Investigators believe that restoring the balance between these two axes of the~     RAS is essential to improve CPC function and enhance their reparative capabilities. These~     observations have led to the hypothesis that genetic modification of CPCs by overexpression~     of ACE2/Ang-(1-7) will enhance their reparative function and improve their potential to~     attenuate myocardial ischemia-induced cardiac damage.~   "
54139|NCT02348476|"~     This study is a retrospective chart review to assess the tolerability and efficacy of~     treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.~   "
55731|NCT02327663|"~     This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B~     patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group~     and HBeAg negative Chronic hepatitis B(CHB)group.~   "
54140|NCT02348463|"~     Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was~     conducted in an attempt to investigate if treatment of bacterial vaginosis in early~     pregnancy could reduce the risk for preterm delivery.~      Women were screened for bacterial vaginosis during the first visits at the maternal health~     care unit with a vaginal sample that were taken by the midwife or by herself. After the~     vaginal samples was air dried it was sent to the gynaecological department and was~     investigated using Hay/Ison classification. Eligible women were those who had lived in~     Skaraborg and delivered at Skaraborg hospital.~   "
54141|NCT02348450|"~     This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP~     and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer~     and to explore the reasonable first-line therapy for Chinese population. An open-label,~     multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio~     with an estimation of 308 eligible participants.~   "
54142|NCT02348437|"~     The purpose of this study is to determine the functional outcome of repairing the pronator~     quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar~     locked plating.~   "
54143|NCT02348424|"~     This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal~     pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The~     primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal,~     cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.~   "
54144|NCT02348411|"~     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided~     focused ultrasound thermal ablation of a designated area in the brain of patients suffering~     from medication-refractory MDD, using the ExAblate transcranial system.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral~     Anterior Limb of internal Capsule.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of target to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in~     progress, and confirm that the ablation is proceeding according to plan, thus closing the~     therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      After informed consent and screening, eligible subjects will proceed to the treatment. All~     subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits,~     patients will be evaluated for general health, neurological changes (including MMSE~     exam),and efficacy measurements as well as for device/procedure related adverse events that~     may have occurred during the follow-up period. Six (6) month follow up visit will also~     include Full Battery Cognitive/Neurological Testing~   "
54145|NCT02348398|"~     The goal of this clinical research study is to learn if the combination of topotecan and~     pazopanib can help to control recurrent cervical cancer. The safety of the study drug~     combination will also be studied.~   "
54146|NCT02348385|"~     The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco~     smokers and nonsmokers.~   "
54147|NCT02348372|"~     GSK1278863A is a novel small molecule agent, which stimulates erythropoiesis through~     inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is~     being developed for the treatment of anemia. This study, PHI115385, will be the first~     administration of GSK1278863A to Japanese subjects to investigate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses in healthy Japanese adult~     subjects. Healthy Caucasian adult subjects will be included in order to compare~     pharmacokinetics of GSK1278863A and its metabolite(s), and pharmacodynamics of GSK1278863A.~   "
54148|NCT02348359|"~     The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of~     vision loss due to wet AMD.~   "
54149|NCT02348346|"~     Environmental cleanliness As antimicrobial resistance is a major and overall deteriorating~     public health problem international cooperation is necessary. Continued progress is needed~     to implement and improve programmes for the prevention and control of antimicrobial~     resistance and HAIs.~      Environmental cleanliness might be one of the most important initiatives to reduce HAIs.~     Hospital surfaces are heavily contaminated with bacteria with the highest numbers on~     surfaces closest to the patients. Bed rails, nurse call buttons, curtains, towel dispensers,~     door handles, sinks, floors, clinical information stations, medical devices, stethoscopes,~     staff toilets etc. Actually, general hospital wards and Intensive Care Units are loaded with~     an abundance of potential pathogens 8,9,10. Surviving days, weeks or even months in the~     environment 11. Colonizing patients with bacteria from the hospital environment and getting~     HAIs or even die.~      As most ventilator-associated pneumonias (VAPs) are the result of nosocomial microorganisms~     the environment plays an important role in the acquisition of pathogenic bacteria by~     contaminating health care workers hands and equipment 12,13. Furthermore, ICUs and wards~     struggle with colonized patients with ESBL-bacteria from sinks eventually leading to dead or~     outbreaks of group A streptococcus infections from contaminated curtains 14,15.~      As key healthcare-associated pathogens have the capacity to persist for weeks to months on~     hospital surfaces indirect transmission is a serious threat, especially as antimicrobial~     resistance increases. Hospitalization in a room in which the previous patient had been~     colonized or infected with nosocomial pathogens (e.g. MRSA, VRE, multidrug-resistant~     Acinetobacter, Pseudomonas or C. difficile) has been shown to be a risk factor for~     colonization of infection with the same pathogen for the next patient16. Furthermore, the~     most important risk factor for hand and glove contamination of healthcare workers with~     multidrug-resistant bacteria has been demonstrated to be positive environmental cultures 17.~     To decrease the frequency and level of contamination of environmental surfaces the Centre~     for Disease Control and Prevention recommends routine disinfection of medical equipment and~     environmental surfaces to prevent the spread of potential pathogens through the hospital~     ward or ICU 18. Improved room cleaning has shown to decrease the risk for MRSA, VRE and C.~     difficile acquisition. Unfortunately, environmental cleaning is frequently inadequate. Less~     than 50% of hospital room surfaces are adequately cleaned and disinfected even by~     environmental services personnel. Environmental services personnel have low wages, are under~     time pressure to clean rooms quickly with high turn-over rates of patients. Novel materials~     and cleaning technologies have been developed as ultraviolet germicidal irradiation (UVGI)~     or hydrogen peroxide vapor (HPV). However, both technologies are expensive and can just be~     used for terminal cleaning and not during routine daily care 16. Self-disinfecting surfaces~     may overcome these problems. Once applied antimicrobial surfaces will continuously reduce~     the bioburden of nosocomial pathogens preventing transmission and decrease HAIs.~      MVX One of these self-disinfecting products is MVX. MVX contains titanium dioxide which by~     the use of nanotechnology is now available for use in the health sector. Working as a~     photocatalyticum it generates, in the presence of light, hydroxy radicals and oxygen~     radicals for at least five years after coating hospital surfaces (durability test TUV~     Rheinland). Laboratory tests show that MVX is effective in killing bacteria, viruses and~     fungi (see attachment 1 for summary test results).~      The positive results reported on the effects of MVX from laboratory evaluations still have~     to be confirmed in the clinical setting. After getting the CE-marking Gelderse Vallei~     Hospital in Ede, the Netherlands, will be the first hospital in Europe to study the efficacy~     of MVX in the Intensive Care Unit (ICU).~   "
54150|NCT02348333|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male~     adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each~     step. After follow-up examination in the step of lower dose, the next dose is administered.~   "
54151|NCT02348320|"~     This is a phase 1 open-label study to evaluate the safety and immunogenicity of a~     personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines~     will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that~     personalized polyepitope DNA vaccines will be safe for human administration and capable of~     generating measurable CD8 T cell responses to mutant tumor-specific antigens.~   "
54152|NCT02348307|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in~     fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in~     each step. After follow-up examination in the step of lower dose, the next dose is~     administered. The effect of food on PK/PD of FYU-981 is also investigated.~   "
54153|NCT02348294|"~     1. The objective of this study is to acquire knowledge about the development of reactive~          hyperaemia and inflammatory responses of the skin after shear- force and pressure~          loading. We want to investigate if patients with diabetes type 2 will develop more skin~          damage, because of a decreased microvascular function.~        2. The second objective of this study is: to investigate if the cytokine production of the~          skin is increased in patients with type 2 diabetes with a history of Charcot~          osteoarthropathy in comparison with patients with neuropathy without a history of~          Charcot osteoarthropathy.~      The participant is asked to put his left arm on a support cushion. Then we mark an area of~     2.5 cm x 3 cm with a permanent marker at the plantar aspect of the left fore-arm and the~     adhesive side of a Sebutape is placed within this area for collection of IL-1α/ total~     protein concentrations in a non- loaded situation (event 1) for two minutes. Second, we~     measure the cutaneous blood cell flux within the borders of the marked area with a Laser~     doppler. Finally, we measure the erythema index in this area with a colorimeter. Then we~     place the shear- pad over the marked area we apply 9,8 Newton (N) pressure with 19 N shear-~     force for half an hour. After this period a new Sebutape is placed for two minutes, followed~     by cutaneous blood cell flux and the erythema index measurement within the borders of the~     marked area. We repeat these measures after 15 minutes, 30 minutes, 45 minutes and 60~     minutes, At the same time we performed the same experiment at the right arm, but instead of~     loading this arm with shear- force and pressure, we apply only 9,8 N pressure at this arm.~     The same measures with the sebutape, laser doppler and colorimeter are done before and after~     loading of the skin. The measures are repeated at 15 minutes, 30 minutes, 45 minutes and 60~     minutes.~   "
54154|NCT02348281|"~     This prospective, single center, phase II study is to evaluate the efficacy and safety of~     bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative~     breast cancer (mTNBC) patients.~   "
86518|NCT01924923|"~     This pilot study intends to investigate a new biopsy technique that will decrease the~     incidence of tumor cells in the biopsy tract.~   "
54155|NCT02348268|"~     Mechanical neck pain is a musculoskeletal disorder usually associated with work absenteeism.~     Myofascial release therapy (MRT) is currently under development and has the treatment of~     mechanical neck pain as one of its main focal points. However, there is a paucity of studies~     reporting its effectiveness. For that purpose a randomized single-blind parallel group study~     was designed to compare the effectiveness of MRT with manual therapy (MT) for treating~     occupational mechanical neck pain. The sample (n=59) was randomly assigned to two~     therapeutic intervention programs. Group I patients were treated with MT and Group II~     patients were treated with MRT. Variables studied were intensity of neck pain, cervical~     disability, quality of life (QoL), craniovertebral angle and ranges of cervical motion.~   "
54156|NCT02348255|"~     This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and~     carmustine and to see how well they work in treating patients with glioblastoma multiforme~     that has returned for the first time. NovoTTF-100A, a type of electric field therapy,~     delivers low intensity, alternating wave-like electric fields that may interfere with~     multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective~     treatment for glioblastoma multiforme.~   "
54157|NCT02348242|"~     60% of the patients hospitalized in intensive care and sedated suffer from insufficient~     inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to~     57%). The prevention of such corneal damage can be done using several techniques (artificial~     tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never~     been compared in a rigorous study. Therefore it is not yet possible to determine an~     evidence-based strategy to prevent corneal damage in intensive care patients.~      This study aims at assessing the efficacy of primary prevention of corneal lesions in~     intensive care patients, in order to elaborate an evidence-based nursing protocol.~   "
54158|NCT02348229|"~     The investigators designed a prospective randomized, controlled clinical trial then~     recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS~     group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was~     same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included~     clinical parameters and serum indicators.~   "
54159|NCT02348216|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).~   "
54160|NCT02348203|"~     This randomized phase II trial studies the effects of aspirin and zileuton on genes related~     to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to~     tobacco use and may be useful in preventing lung cancer in current smokers.~   "
54161|NCT02348190|"~     The overall objective of the current proposal is to strengthen the putative link between FFA~     induced insulin resistance and atherosclerotic vascular disease (ASVD). To this end, the~     investigators will test the following hypotheses: 1) that FFA induced activation of protein~     kinase C βII (PKC β II) and δ and other serine kinases such as IκB kinase (IKK) in human~     muscle is associated with a decrease in insulin stimulated tyrosine phosphorylation of the~     insulin receptor substrate-1 (IRS-1) and of IRS-1 associated phosphatidylinositol 3 (PI3)~     kinase; 2) that these changes precede the development of insulin resistance; 3) that the~     decrease in IκB-α results in activation of nuclear factor κB (NFκB) and the expression of~     adhesion molecules and cytokines; 4) that PKC and IKK are involved in producing insulin~     resistance and activation of the IκB/ NFκB pathway and lastly 5) that the same mechanisms~     operative in healthy volunteers are also operative in patients with T2DM.The investigators~     will test these hypotheses in normal (current) and diabetic volunteers (previously~     completed) . Euglycemic-hyperinsulinemic clamps will be performed with and without~     co-infusion of lipid plus heparin (to raise FFAs) and by obtaining serial muscle and fat~     biopsies and blood samples will be obtained for measurement of substrates, hormones, enzymes~     and metabolites.~   "
54162|NCT02348177|"~     The purpose of this study is to determine the lopinavir levels in blood of HIV and TB~     infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin~     containing TB regimen and its safety.~   "
54163|NCT02348164|"~     The goal of the research study is to measure and compare the absorption of equivalent~     amounts of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want~     to determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene,~     when both are supplied in comparable citrus fruits.~   "
54164|NCT02348151|"~     It is still not clearly known whether doing the walk test in a course is different from~     doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive~     outcome in this study, we will have an alternative for this test in places where there is~     not enough room, benefiting the assessment of COPD patients' functional capacity. In the~     literature, there are still some controversies about performing the test on a treadmill or~     in a corridor and whether there is interference with the distance walked. Our hypothesis is~     that there is no interference with the distance walked, and thus we have one more option to~     perform the test in case there is no 10-meter corridor available.~   "
54176|NCT02347995|"~     Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with~     implications for strength, function and general health. Although resistive exercise training~     effectively combats this problem, it is unknown whether sub-optimal protein intake limits~     the observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when~     resistive training (RT) is combined with nutritional therapy in the form of post- exercise~     protein consumption. This study would be the first to directly compare RT+protein~     supplementation to RT+placebo (same calories as protein supplement) in those with chronic~     hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in~     the clinical care of this population.~   "
54177|NCT02347982|"~     This study will compose a national database of cardiovascular diseases' risk factors,~     concomitant diseases and the drug usage among the elderly patients in Turkey.~   "
54178|NCT02347969|"~     The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary~     supplement on skin radiance (clinical assessment) for 8 weeks.~   "
54165|NCT02348138|"~     The main purpose this study is to analyze the effects of isometric handgrip training on~     cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under~     anti-hypertensive medication, will be selected and randomly distributed into three groups:~     home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST)~     and control group (CG).Subjects assigned to the HBT and ST will train three times per week~     for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of~     2-min isometric contractions (using alternate hands) at 30% of maximal voluntary~     contraction. However, the subjects of the HBT group conduct the training without daily~     supervision. Subjects randomized to the CG will be encouraged to increase the level of~     physical activity and make healthy eating, without, however, receive specific~     recommendations.Baseline and after 12 weeks of intervention, the following cardiovascular~     risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic~     modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition~     to microalbuminuria. For data analysis, in addition to descriptive statistics, two-way ANOVA~     for mixed model will be applied for within and between groups comparison. If the premises of~     this test are met. The level of significance that will be adopted is p<0.05.~   "
54166|NCT02348125|"~     In this study, 50 children between 3 and 12 years old with formally diagnosed autistic~     spectrum disorders (ASD) and also having significant mitochondrial dysfunction will be~     treated for a 3 month period with the Mitochondrial Cocktail, a combination of specific~     nutritional supplements and metabolite intermediates (including anti-oxidants) and~     bio-energy substrates. A series of neurological and psychological evaluations will be~     conducted by trained evaluators/clinicians to evaluate both the severity and the clinical~     presentation of the ASD/mitochondrial dysfunction with each subject at baseline prior to~     treatment, after the 3 month treatment and again at 6 months, after another 3 month~     non-treatment period. In addition, laboratory investigations will be conducted at the same~     time-points to assess the mitochondrial dysfunction and cellular biomarkers thought to be~     associated with autistic and mitochondrial disorders. These investigations will include the~     analysis of samples of blood and cheek/buccal swabs collected from each child to assess~     select biochemical markers of ASD. The Mitochondrial Cocktail treatment will be administered~     at home once a day continuously for a total of 3 months. All the children in the study will~     be treated with the same Mitochondrial Cocktail (an open label study).~   "
54167|NCT02348112|"~     The aim of this postmarket study is to compare the safety and effectiveness of the Altis~     Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36~     months.~   "
54168|NCT02348099|"~     This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as~     detected with ultrasound and its impact on glycemic variability.~   "
54169|NCT02348086|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on pain and functionality in people with rheumatoid arthritis (RA). SVF contains~     multiple cellular components, including stem cells, with both regenerative and~     anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms~     of RA. This study is designed to evaluate changes in pain and functionality in individuals~     with RA for up to 12 months following SVF treatment.~   "
54170|NCT02348073|"~     Our project aims to develop a new therapeutic approach in epilepsy-associated attention~     disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,~     containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a~     phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA~     supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in~     children with epilepsy. Secondary objectives include:~        -  To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.~        -  To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte~          lipid profiles.~        -  To assess the tolerance of a supplementation of PS-Omega 3.~        -  To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.~        -  To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,~             1. on attention disorders in children with epilepsy,~             2. on quality of life,~             3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects~               aged 6- 16 years, suffering from epilepsy (any type) and attention deficit~               hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V~               criteria in 12 clinical sites in France.~   "
54171|NCT02348060|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with chronic obstructive pulmonary disease~     (COPD). SVF contains multiple cellular components, including stem cells, with both~     regenerative and anti-inflammatory properties. This therapy has shown promise for~     ameliorating the symptoms of COPD. This study is designed to evaluate quality of life~     changes in individuals with COPD for up to 12 months following SVF treatment.~   "
54172|NCT02348047|"~     Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode,~     on intubated, ventilated and sedated patients, during their secondary transfer from an~     hospital to another, by a SMUR team.~   "
54173|NCT02348034|"~     The study will explore the ability of negative pressure wound therapy (Prevena dressing) to~     reduce post operative superficial surgical site infection rate in elective colorectal~     surgery. Half of the participants will receive Prevena dressing on closed incision~     immediately after the operation while other half will receive conventional surgical~     dressing.~   "
54174|NCT02348021|"~     Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients~     in Japan. All patients will receive a DCS and will be followed for 2 years.~   "
54175|NCT02348008|"~     This is an open label, multi-institutional, single arm study of dose escalation phase Ib~     cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with~     bevacizumab. No randomization or blinding is involved.~   "
54191|NCT02347787|"~     This is a multi-center randomized controlled trial comparing the effectiveness of community~     health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low~     socioeconomic status to improve their health outcomes.~   "
54179|NCT02347956|"~     Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the~     tumor is the only curative treatment for gastric cancer. However, surgical procedure~     accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma~     and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was~     accepted as safe and effective alternative to open gastrectomy. Furthermore, reduced port~     and single port laparoscopic gastrectomy are considered to minimize the surgical trauma~     during gastrectomy. However, limitations of laparoscopic approach using reduced port~     includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. To~     overcome these limitations, robot surgery using novel single-site technology enabled~     surgeons to perform the surgical procedure reducing the number of trocar from three to one~     for insertion of scope and two robotic arms. Previously, successful application of~     single-site technology for cholecystectomy and hysterectomy were reported. The aim of this~     study is to validate the safety and feasibility of reduced port robotic distal gastrectomy~     using single-site technology for the surgical treatment of gastric cancer.~   "
54180|NCT02347943|"~     This study evaluates long-term safety and effectiveness of primary sinus surgery in a~     real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute~     rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using~     commercially available sinus instrumentation (e.g. sinus balloon catheters, powered~     microdebriders, manual instruments).~   "
54181|NCT02347930|"~     Establish an integrated evaluation system of ultrasound technology for the prognosis of~     acute kidney injury, and in order to achieve non-invasive, reliable early diagnosis gold~     standard. Set up collabration with the expert in National Cheng Kung University Medical~     Center of Taiwan who did a lot of excellent work in basic research of prevention the~     progression of acut kidney injury. Study the experience about prevention progression of~     kidney disease in clinical and basic field. Establish cooperation with the professional in~     Hong Kong University of Science and Technology. To set up the system of natural products~     research and assess the Astragalus medicinal value.~   "
54182|NCT02347917|"~     This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed~     and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).~   "
54183|NCT02347904|"~     In this prospective single arm study the investigators will assess the feasibility of S-1~     and Oxaliplatin as adjuvant treatment in patients with esophageal cancer.~      The primary objective is to assess the feasibility of administering adjuvant S-1 and~     Oxaliplatin (SOX) in patients with esophageal cancer after neoadjuvant chemoradiotherapy~     with paclitaxel and carboplatin and esophagectomy. Primary end point is the percentage of~     patients completing the preplanned number of 6 cycles of SOX.~   "
54184|NCT02347891|"~     The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance~     therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with~     standard of care. This is a multicentre double-blind, placebo-controlled trial.~   "
54185|NCT02347878|"~     Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and~     often debilitating syndrome, which was reported to occur in about 40% patients who received~     lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH,~     although some physicians consider bed rest for at least 6 hours to be a useful methods (Some~     recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH).~     Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have~     played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R~     inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and~     lower the severity of PLPH.~   "
54186|NCT02347865|"~     The purpose of the study is to describe the characteristics and management of post~     menopausal women with osteoporosis treated with Prolia in France, and examine the use of~     Prolia in routine clinical practice in France~   "
54187|NCT02347852|"~     The purpose of this trial is to quantitatively assess the average amount of physical~     activity that patients are capable to perform while receiving regorafenib for the treatment~     of metastatic colorectal cancer. The assessment of this reference value, measured by CE~     (Conformité Européene)-certified pedometer and international physical activity~     questionnaire, will allow an estimation on the feasible amount of physical activity for~     patients in this therapeutic setting.~      This study is available for patients who are included in the global non-interventional study~     CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients;~     NCT01843400) in Austria.~   "
54188|NCT02347839|"~     The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed~     by adjuvant gefitinib to see how well it works in treating patients with unresectable stage~     III NSCLC harboring EGFR mutations.~   "
54189|NCT02347826|"~     An email questionnaire about subjective satisfaction and discomfort has been sent to 243~     patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1~     year after treatment.~   "
54190|NCT02347813|"~     This study is proposed based on our work showing that the diabetes drug Pioglitazone~     strongly inhibits growth of tissue cultured squamous cell carcinoma (SCC) of the skin. This~     occurs at concentrations readily achievable by oral administration of this drug using doses~     currently approved for the treatment of diabetes. In our study, we propose to enroll 40~     non-diabetic adult subjects (18-80 yrs of age inclusive) with a documented clinical history~     of frequent occurrence of skin squamous cell cancer to receive Pioglitazone (Actos®,Takeda~     Pharmaceuticals). Each subject will receive usual care for all new tumors they develop while~     on study (i.e, excision and plastic repair). The study protocol will randomize (1:1)~     patients for 6 months of observation followed by 6 months of treatment (group 1) or 6 months~     of treatment with drug followed by observation for 6 months (to examine washout effects).~     The biopsy specimens collected on and off therapy will be examined to determine if they~     express AKR1C3, an enzyme we believe increases resistance of SCC to prostaglandin~     inflammatory mediators. We will also examine the histologic grade of the removed tumors and~     study whether Pioglitazone treatment can decrease the number of aggressive versus well~     differentiated tumors in study patients. This pilot study is designed to detect a~     statistically significant change in SCC tumor numbers but is not sponsored by the drug~     manufacturer. The data obtained will not be used to effect a change in the product label.~   "
54193|NCT02347761|"~     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational~     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease~     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)~     guidelines.~   "
54194|NCT02347748|"~     Background: Pre anaesthesia anxiety in children is a strong predictor of postoperative~     behavior challenges and outcomes. In addition, intra-operative stress can precipitate~     post-traumatic stress symptomatology. Comfort Talk, consisting of rapport, relaxation, and~     reframing of potentially stressful experiences, applied pre-operatively in script form, has~     been highly successful in alleviating anxiety and positively affecting procedural outcomes~     in adult patients undergoing interventional procedures. No published literature exists~     evaluating its' impact in paediatric cardiac catheterization. Purpose: To investigate the~     impact of comfort talk on the level of pre-induction anxiety, procedural and recovery~     experience, as well as short-term post-procedural behaviour and satisfaction after discharge~     in pediatric patients undergoing cardiac catheterization procedures. Design: Prospective~     randomized, double blind controlled trial. Participants: 160 children, ages 7-18 years,~     having a cardiac catheterization procedure under general anaesthesia. Intervention: Group A~     will be read a pre-procedure comfort talk script in the pre-procedure work-up area; Group B~     will be read a pre-extubation (before the breathing tube is removed) script ; Group C will~     be read a pre-procedure plus a pre-extubation script; Group D will not be read any script.~     All groups will be treated according to the standard of care approaches usually provided for~     anaesthesia, catheterization, and recovery. Outcomes: We will compare the effect of the~     script strategy on preoperative anxiety. Procedural and recovery measurements will include~     room time in the catheterization suite, time to discharge from the recovery room; drug use,~     vomiting, rebleeds, and cardiorespiratory stability. Postoperative behaviour will be~     assessed by questionnaire. Postoperative anxiety and pain will be secondary outcome measures~     using queries on 0-10 verbal self-report scales Hypotheses are:~        1. Patients being read a preoperative Comfort Talk script will experience less anxiety~          prior to anaesthesia induction.~        2. The reduction of anxiety prior to induction is associated with better immediate and~          short-term recovery outcomes.~        3. Patients being read a pre-extubation script will recover better than controls.~        4. The combination of a pre-procedure script and a pre-extubation script will have the~          greatest positive effect on physical and emotional well-being in the immediate recovery~          period and at short term follow-up.~   "
54195|NCT02347735|"~     Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide,~     estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the~     predominant curative treatment type for colorectal cancer, but has a major impact on the~     patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the~     development of frequently observed and severe postoperative complications. The most~     important complication after colorectal surgery is anastomotic leakage (AL), which has an~     incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates~     of up to 40%. Even though many attempts have been made to reduce the incidence of this~     dreaded complication, none of these interventions have been successful so far. Despite~     proper patient selection and improvement in surgical techniques, the percentage of AL has~     been stable for years.~      Objectives: To investigate whether recently identified patient-specific factors can predict~     the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal~     cancer.~      Study design: Prospective observational study Study population: Adult colorectal cancer~     patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL~     within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample,~     I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood,~     VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis~     measurements on CT-scans, SNAQ & MUST scores~   "
54196|NCT02347722|"~     The purpose of this study is to evaluate existing biomarkers and see if they can be used to~     accurately diagnose the etiology of heart failure.~   "
54197|NCT02347709|"~     The primary purpose of this study is to determine the degree of loss of epidermal nerve~     fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will~     be to determine whether the degree of epidermal nerve fiber loss, the clinical examination,~     nerve conduction studies or the molecular profile correlates with appearance of lower~     extremity ulcers in patients with diabetes.~   "
54198|NCT02347696|"~     This study aims to evaluate the effect of two programs of different intensity level of~     physical activity, of low glycemic index Mediterranean Diet and of the interaction of both,~     on NAFLD score and on the lipid composition of the erythrocyte membrane.~   "
54199|NCT02347683|"~     The optimal timing to measure thyroglobulin(Tg) after thyroidectomy is unknown in patients~     with thyroid cancer. The ATA and NCCN guidelines are not specific on optimal timing of Tg~     levels in post-op state and suggest anywhere between 2-12 weeks.~      Hypothesis - Post -op Tg nadirs at 6-8 weeks .~      Primary Objective -Determine optimal timing of post thyroidectomy Tg nadir, so to determine~     the most accurate time to check post operatively.~      Secondary Outcome - Determine factors that will affect Tg levels post operatively.~      All adults age 19 and above already planning to undergo near total /total thyroidectomy for~     reasons unrelated to the study.~      Measure Tg , Tg Ab and TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, and 3 month in~     patients with pathology confirmed benign disease.~      Measure Tg , Tg Ab , TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, 3 month, 6 month, and~     12 month in patients with thyroid cancer.~   "
54200|NCT02347670|"~     The project aims to determine the effectiveness of a patient-centered health care delivery~     system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over~     the course of 1 year, a 6-person team comprised of one attending physician; project managers~     and community health educators, ophthalmic technician, and patient navigators will complete~     a baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will~     assist participants in community groups and a portion of the office-based participants with~     scheduling follow-up appointments~   "
54201|NCT02347657|"~     This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter~     study in people with CF who are homozygous for the F508del CFTR mutation.~   "
54212|NCT02347514|"~     Community health centers across the US are seeking to address the growing prevalence of~     diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians'~     Network (MWCN) to conduct a research study to train community health center staff and~     providers to implement and sustain diabetes group visits, also referred to as shared medical~     appointments, at their health center. The study's aims are to: 1) Develop, conduct, and~     evaluate a training program for health center staff to implement a diabetes group visit~     intervention in their health center; 2) Assess the implementation of diabetes group visits~     in the community health center setting and determine the cost of implementation; 3) Assess~     the feasibility and cost of implementing a text-messaging intervention in addition to the~     implementation of diabetes group visits in the CHC setting at one health center and 4)~     Assess the impact of the diabetes group visits alone and diabetes group visits plus~     text-messaging on diabetes process measures, patient outcomes, and patient satisfaction~     compared to control patients from the same health center with six months of follow-up once~     the six-month group visit program ends.~   "
54202|NCT02347644|"~     The objective of this study is to explore the efficacy of brief motivational interventions~     (BMIs) for treatment of youth with alcohol and other drug problems after at least 3 months.~     The results of previous studies indicate that brief interventions for unhealthy alcohol use~     have been shown to be effective in primary care settings, with most studies focusing on~     adults and few studies focusing on youth. To date, no BMI studies have been conducted in the~     Ukraine among youth with alcohol or other drug use. Of particular concern are emerging~     adults ages 18-25 who may be at particularly high risk for alcohol problems given historical~     events related to the fall of the Soviet Union and the subsequent economic down turn.~      This study will evaluate the efficacy of BMI by comparing BMI and no BMI conditions among~     two samples of youth screening positive on the prescreen survey for risky drinking. The~     subject pool will come from the Psychoneurological Department: the first location is located~     in the Railway Clinical Hospital, its clinical base, and the second in classes in the~     department at Kiev National Medical University.~      The total sample of 120 will be broken down to 1.) 60 patients from Railway Clinical~     Hospital; and 2.) 60 students from Kiev National Medical University. Participants will be~     stratified by recruitment site and randomized to condition: BMI and control, with follow-up~     assessment at 3 months. In addition to being the first of study to evaluate the efficacy of~     BMI on substance use problems among youth in Ukraine, this study will examine BMI~     intervention processes in relation to alcohol and other drug outcomes. Findings will inform~     research and clinical practice to enhance early identification and prevention of problematic~     alcohol use trajectories among emerging adults~   "
54203|NCT02347631|"~     This is a prospective, single center, randomized, bilateral crossover, dispensing clinical~     trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of~     corneal epithelium over two months of daily wear compared to wear of a control high oxygen~     permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to~     correlate these changes with alterations in the lid wiper, tear film and cellular changes at~     the limbus. The total proposed duration of this study is 12 months to ensure enrollment of~     up to 94 established contact lens wearers, with anticipated completion of 84. Data will be~     collected at baseline and following 2 months of daily wear for each lens type. Based upon~     data from the investigators previous contact lens clinical trials, a 1 month washout period~     is required prior to initiating lens wear to eliminate any potential residual solution or~     lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to~     commence upon Institutional Review Board approval.~   "
54204|NCT02347618|"~     The purpose of this study is to determine whether a short-course of stereotactic body~     radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and~     well-tolerated.~   "
54205|NCT02347605|"~     The purpose of this study is to determine if changing the timeframe (relative to cue~     presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms~     of tobacco craving and withdrawal that occur when smokers are presented with smoking cues.~     In this cross-over study, all subjects attend three laboratory sessions at which either~     nicotine lozenge or placebo is given prior to presentation of smoking cues or after~     presentation of smoking cues. The order in which the three conditions will be presented are~     randomized.~   "
54206|NCT02347592|"~     The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more~     expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The~     investigators used these catheters in parallel for several years. To clarify what catheter~     has least problems the investigators performed a comparative study to clarify if outflow~     problems differed between these catheters.~   "
54207|NCT02347579|"~     Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients~     experience dramatic decline of overall well-being, despite the absence of any apparent~     physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and~     experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral~     nerve damage. The debate on the aetiology of CRPS-I is still open.~      The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive~     interventions. Current (inter)national guidelines recommend physiotherapy as the best~     non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded~     Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be~     effective (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE~     study, articles in preparation). By reducing pain-related fear EXP might reconcile motor~     output and sensory feedback.~      Another type of pain is lower back pain (LBP), which affects 70% to 85% of general~     population, but usually heals within 12 weeks in 90% of patients. The rest of the patients~     suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows~     that also in these patients cognitive and behavioural aspects of pain are important and~     related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several~     studies have demonstrated the success of GEXP in this patient group: GEXP resulted in~     improvements in pain-related fear, catastrophizing, performance of daily relevant~     activities, and in pain intensity (Leeuw et al., 2008).~      This study aims to investigate the effect of GEXP on brain regions involved in the~     processing of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on~     tactile discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of~     tactile discrimination thresholds, 2) a functional reorganization of primary and secondary~     somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in~     LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation,~     4) changes in resting state connectivity between emotional and sensory brain areas, 5)~     changes in measures reflecting white matter integrity. No systematic changes are expected in~     the healthy controls.~      Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging~     (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that~     all patients receive as part of usual care. Anatomical as well as diffusion-weighted and~     T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a~     3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment /~     healthy controls) as between-subjects variable and time (pre-, during, post-treatment and~     follow-up) as within-subject variable.~   "
54208|NCT02347566|"~     Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary~     lifestyle. This contributes to increase the number of hospitalizations and mortality.~     Changing this lifestyle is a major objective of the management of these patients. Pulmonary~     rehabilitation helps patients to increase their fitness, but modifying a longstanding~     sedentary habit is more difficult to achieve. This project aims at modifying patients' long~     term physical activity with a physical activity coaching programme. This will help patients~     to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and~     contribute to reduce hospitalizations, increase quality of life and survival.~   "
54209|NCT02347553|"~     It is known that hypoglycaemia affects various domains of cognitive function. One aspect of~     cognitive function is 'social cognition', which is our ability to interpret facial~     expressions, gestures and speech. It is an approach to understanding human judgement and~     behaviour. There is anecdotal evidence for negative behavioural responses such as~     aggressiveness and argumentativeness during hypoglycaemia and while research has shown that~     hypoglycaemia can cause significant changes in mood, little information exists regarding its~     effect on social cognition. It is therefore not known whether hypoglycaemia affects this~     aspect of cognitive function but, if it did, it could explain why people with low blood~     sugar due to insulin treatment are often resistant to offers of help (for example, they may~     misinterpret a friendly gesture as being threatening). Knowledge of this effect of~     hypoglycaemia can be used to educate relatives and carers of people with diabetes who may~     suffer this problem.~      Hypoglycaemia is also known to have an effect on the electrical rhythm of the heart. This is~     thought to be secondary to adrenaline secretion during hypoglycaemia which provokes a fall~     in the blood level of potassium, a type of electrolyte. Other electrolyte imbalances are~     known to predispose to heart rhythm abnormalities or arrhythmias in other situations and it~     is not known if the levels of these other electrolytes are affected during hypoglycaemia.~      Using specific tests of social cognition and continuous electrocardiographic (ECG)~     monitoring, this study aims to find out whether social cognition is affected by an hour of~     hypoglycaemia and how hypoglycaemia affects blood electrolyte levels and the~     electrophysiology of the heart.~   "
54210|NCT02347540|"~     This study is a cross-sectional case-control study where classical as well as more~     innovative risk factors for CVD will be explored.~      In western countries, more women than men die of cardiovascular disease (CVD), making CVD in~     women an important public health issue. Misdiagnosis of CVD in women is frequently observed,~     posing the clinician for diagnostic and therapeutic dilemmas that can easily result in~     inadequate treatment and worse prognosis. Despite these challenges, CVD in women has been~     underexposed in scientific research.~      Women have gender-specific risk factors like a history of preeclampsia (PE) that contribute~     to their risk for CVD. PE complicates 5-10% of pregnancies, recurs in ~25% and is associated~     with a 2-4 fold increased risk for CVD. Moreover, pre-symptomatic heart failure (HF) stage B~     occurs in 40% of women with a history of PE. HF stage B is thought to precede the~     development of the, mortality related, clinical HF stages C and D (structural heart disease~     in combination with symptomatic disease). Early detection and tailored intervention of women~     with stage B HF decreases progression to the clinical stages and might therefore improve~     clinical outcome and cardiovascular related mortality.~      Phenotypic presentation of HF is currently split up between systolic HF also called HF with~     reduced ejection fraction (HFrEF) and diastolic HF or HF with preserved ejection fraction~     (HFpEF). Women more often have HFpEF in contrast to men. Different pathophysiology and~     disease progression in women compared to men seems to be an important underlying factor. The~     current clinical HF diagnostic tools (e.g. natriuretic hormones and high sensitivity~     troponins) fail to identify early changes that prelude adverse cardiac remodelling and HF,~     and do not discriminate between HFrEF and HFpEF. Moreover, there are sex-related differences~     in biomarker levels for detection of CVD. As a result, clinicians are forced to wait for the~     failing heart to become clinically evident before they can intervene. Therefore, there is an~     urgent need to assess novel biomarkers that could help select high risk women needing~     further follow up and intervention. Biomarkers may not only improve early diagnosis but may~     also unravel disease pathways of HFpEF. Especially when combined with measurements of~     subclinical, surrogate risk markers.~      Objectives~        -  To determine the impact of PE on incidence of macro-and micro-vascular dysfunction~          reflected by surrogate measures for coronary artery disease (CAD) and HFpEF.~        -  To perform a genome wide association study (GWAS) and associate novel biomarker~          expression levels with endothelial function, cardiac diastolic function and IMT~          measurement.~        -  To identify risk factors and surrogate measures for CVD in a) former PE patients~          without HFpEF, b) former PE patients with HFpEF and c) healthy parous controls.~      Study population Cases: women with a history of PE Controls: women with uncomplicated~     pregnancies in the history. Measurements will be performed in clusters at postpartum~     intervals of: ½-2, 5-10, 10-15 and 15-30 years. Number of inclusions will be: 425, 350, 282~     and 233 for each follow-up group respectively.~      Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE~     patients. Novel biomarker detection in former PE patients associated with HF in general and~     HFpEF in particular.~      Secondary endpoints~        -  Lifestyle (questionnaire)~        -  Cognitive ability (questionnaire)~        -  Depression score (questionnaire)~        -  Metabolic syndrome (MetS)~        -  Arterial endothelial function (Flow mediated dilation (FMD))~        -  Intima Media Thickness (IMT)~        -  Glycocalyx thickness (by means of the Glycocheck)~        -  Venous function (plethysmograph)~        -  Electrocardiogram (ECG)~        -  Ergometry~   "
54211|NCT02347527|"~     The overall goals of this project are to determine the impact of an implicit priming~     intervention, designed to alter food perceptions, on both brain responses to food and on~     food intake behaviors in overweight/obese individuals. The investigators hypothesized that~     this bottom-up sensory-level conditioning approach would effectively result in reduced~     preference for high-calorie foods.~   "
62215|NCT02242903|"~     The main purpose of this study is to evaluate the safety and how well the body will handle a~     single dose of study drug, LY3079514. This study will last about 12 weeks for each~     participant.~   "
54213|NCT02347501|"~     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves~     psoriasis severity after 24 weeks of treatment in 60 participants with psoriasis who do not~     have type 2 diabetes mellitus, and who are due to receive a course of narrowband~     ultraviolet-B phototherapy (NB-UVB). The investigators will compare the change in psoriasis~     severity in 60 participants treated with both sitagliptin and NB-UVB to 60 participants~     treated with NB-UVB alone. Participants will be recruited from two centres and after a 3~     week run-in period will be followed prospectively for 36 weeks. Participants will be~     stratified by centre, plasma glycated haemoglobin level (HbA1c), obesity status and previous~     response to NB-UVB, after which they will be randomly allocated to Arm A or Arm B.~     Participants will be treated with either sitagliptin for 24 weeks and NB-UVB (Arm A), or~     NB-UVB alone (Arm B).~      Both the research participants and the investigators will be aware of the trial arm to which~     the research participant has been allocated randomly (open-label study). Research~     participants are prohibited from using systemic psoriasis therapy for the duration of their~     trial involvement.~      Participants will be assessed at 8 study visits over 39 weeks. Participants will complete~     questionnaires, have a medical history recorded and physical examination, blood sampling and~     skin biopsies taken (in a small number of willing participants at 2 visits).~      The following endpoints will be analysed:~      Changes in psoriasis severity at 24 and 36 weeks; changes in validated quality of life~     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,~     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles;~     changes in cytokines, hormones, expression of immune proteins in blood and skin biopsies;~     and genetic profiles that predicts best response to sitagliptin therapy.~      The investigators hypothesize that sitagliptin therapy decreases psoriasis severity.~   "
54214|NCT02347488|"~     This study aims to test the effectiveness of a novel combined endotracheal tube holder and~     bite guard when compared with the current standard of care, tape and an oral airway.~   "
54215|NCT02347475|"~     This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion~     in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in~     premature neonates. These changes will be measured in relation to feeding, before and after~     a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for~     necrotizing enterocolitis (NEC) - a condition with significant mortality and long term~     morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes~     will allow for planning, studying and implementing risk avoidance and minimization~     strategies.~   "
54216|NCT02347462|"~     Bilevel Positive Airway Pressure (BiPAP) is increasingly being reported as an effective and~     safe method of respiratory support for children with severe asthma exacerbations~     unresponsive to standard therapies and with impending respiratory failure. Much of the~     evidence base supporting its use comes from retrospective observational studies, and there~     is currently a lack of data from randomized controlled trials to inform this practice.~      The investigators hypothesize that the use of BiPAP in children with moderate to severe~     asthma exacerbations could reduce the length of hospital stay, need for invasive~     ventilation, and use of intravenous bronchodilators. The investigators aim to test this~     hypothesis by randomizing children attending the Emergency Department with a moderate to~     severe clinical severity score refractory to inhaled bronchodilators to receive either BiPAP~     in addition to standard asthma care, or standard care alone.~   "
54217|NCT02347449|"~     The main goal of this study is to characterize whether the results of the Oncotype DX® assay~     affect the physician's treatment recommendations for the adjuvant treatment of women with~     ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential~     candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.~   "
54218|NCT02347436|"~     The known correlation between benign prostatic hypertrophy (BPH) and hypertension could be~     explained by 3 theoretical pathway models. Whether hypertension causes BPH, BPH causes~     hypertension or the two are caused by a common factor is currently unknown.~      In this study it will be investigated whether hypertension is due to the direct effects of~     infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia.~     The approach will be blood pressure measurement in patients who will have a resection of the~     prostate.~   "
54219|NCT02347423|"~     The background of the present clinical trial is the overall aim of the World Health~     Organization (WHO) to obtain eradication of polio in the world. As part of this overall~     plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable~     price, needs to be available in low resource third world countries. The intention of the~     present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in~     the target population and do not decrease the immunogenicity clinically significantly~     compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the~     trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10~     and 14 weeks of age.~      A total of 824 healthy infants will be included in the trial.~   "
54220|NCT02347410|"~     This study evaluates the safety and effectiveness of the Spineology Interbody Fusion System~     (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic~     single-level lumbar degenerative disc disease.~   "
54221|NCT02347397|"~     This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to~     compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head~     and SL-PLUS Stem in hemiarthroplasty of the hip~   "
54222|NCT02347384|"~     This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare~     the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte~     ball head and SL-PLUS Stem in total hip arthroplasty~   "
54223|NCT02347371|"~     The purpose of this registry is to determine the long term outcomes of heart~     transplantations performed at the Semmelweis University Heart and Vascular Center. All~     eventual interventional and non-interventional procedures will be accounted for and~     summarized.~   "
54224|NCT02347358|"~     This study is to test a hypothesis that temporary implantation of JRecanTM blood flow~     recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a~     major intracranial artery occlusion following IV r-tPA can provide a greater rate of early~     successful recanalisation than treatment of IV r-tPA alone.~   "
54272|NCT02346734|"~     The primary objective of this study will be to assess the feasibility and patient acceptance~     of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.~      Our hypothesis is that home telemanagement will be effective and useful in the~     rehabilitation of multiple sclerosis patients. Specifically, the investigators hypothesize~     that home telemanagement using a daily exercise diary, monitoring of compliance with a~     tailored exercise program and regular assessment of strength and motor functions will: 1. Be~     feasible and acceptable in patients with multiple sclerosis 2. Improve patient compliance~     with home exercise program 3. Increase patient mobility and motor functions 4. Be a feasible~     and effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve~     quality of life~   "
54225|NCT02347345|"~     The investigator's hypothesis is that active injectors will show a partial reduction in~     markers of immune activation with HCV therapy whereas non-injectors will show a more~     significant reduction in these markers, and will exhibit levels of immune activation that~     approach that seen in similarly studied healthy volunteers.This is based on observations~     that this group of investigators have made. They have shown that individuals who inject~     drugs have high level of immune activation in blood and tissue. Immune activation or chronic~     inflammation has been associated with accelerated aging, cardiovascular, renal and liver~     disease as well as CNS dysfunction. It remains unclear whether increased levels of immune~     activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C,~     chronic opiate use, or perhaps combinations of all 3. To understand the potential~     contribution of infection with Hepatitis C the investigators will compare levels of immune~     activation pre- and post treatment with an all oral, one pill once daily, interferon sparing~     treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting~     with drugs and the other free of injection for at least 4 months. Immune activation~     comparisons will also include non-injecting healthy volunteers.~   "
54226|NCT02347332|"~     For patients relapsing after platinum-based therapy, few data are available. The current use~     of cetuximab associated with radiotherapy in localized disease and associated with~     platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic~     options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine~     demonstrated superior antitumour activity to vinorelbine in preclinical animal models.~     Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN,~     based on a clinical review, show encouraging antitumour activity and an acceptable safety~     profile. Therefore the combination of vinflunine and methotrexate appears a promising~     salvage regimen after platinum failure.~      The present study has been designed as a multicenter, randomised phase III study which will~     compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN~     patients having failed platinum-based therapy.~   "
54227|NCT02347319|"~     Purpose~      - To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients~     with elevated transaminase chronic liver disease.~   "
54228|NCT02347306|"~     Cardiovascular disease remains the leading cause of death worldwide. Identifying individual~     patients at risk of a suture adverse events, including myocardial infractions (heart~     attacks), remains a major diagnostic challenge. Recent studies have shown that coronary~     plaques responsible for hear attack are composed of a large lipid core with a thin overlying~     fibrous cap. Although these features can be identified using invasive imaging modalities,~     non-invasive imaging options remain limited due to their poor spatial resolution. Recently~     the investigators have developed and validated a novel tool that will allow us to~     characterise coronary plaque composition based on dual source CT images. Our aim is to~     assess this tool within a cohort of patients who have already undergone a coronary CT as~     part of a previous study.~   "
54229|NCT02347293|"~     The experimental model is a semi-acute, over-night, study where the purpose is to evaluate~     food factors related to colonially derived regulation and satiety in healthy subjects.~   "
54230|NCT02347280|"~     LAY SUMMARY~      Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation~     of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe~     illness. The present treatment for fulminant colitis is a total abdominal colectomy with end~     ileostomy. This means, a surgery is performed which removes the entire diseased colon. The~     end of the small intestine is then brought out to the front of the abdomen as a stoma, and~     the patient wears a bag. Despite this invasive treatment, there remains a significant rate~     of death (38-50%). In addition, patients have a long recovery after this long operation and~     many (67%) will not be fit for a second big operation to remove the stoma (that is to~     reconnect the intestine).~      The purpose of our study is to determine if a loop ileostomy with colonic lavage will result~     in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the~     abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is~     washed with a warm solution (like the solution used in a colonoscopy preparation) and then~     treated with an antibiotic via this ileostomy. So far, one study has been done using a loop~     ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42~     patients that underwent the standard of care (complete removal of the colon with end~     ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in~     rate of death compared to the standard of care. Also, in the study, patients who underwent a~     loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma).~     The purpose of this study is to see if a loop ileostomy with colonic lavage can treat~     patients with fulminant colitis with less risk of death than the standard of care.~      Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria,~     he/she will be asked by the surgeon on-call if they would like to participate in this~     research study. If they agree to be in this study, they must first sign a consent form. They~     may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or~     the standard of care arm. After surgery, all patients will receive the same standard routine~     care. During the hospital stay, information will be taken from their chart for purposes of~     the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months~     after surgery. If the patient decides to be in the study, the patient will be expected to~     complete all the follow up study visits. The patient will not be required to do anything~     extra or have any extra tests if they decide to be in the study at any of these visits.~   "
54231|NCT02347267|"~     The impact of reduction in consumption of caloric and no caloric sweetened beverages on:~        -  weight~        -  body composition~        -  blood pressure~        -  young adults~   "
54232|NCT02347254|"~     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate~     Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's~     disease (LID PD).~      Safety:~      To evaluate the incidence and severity of adverse events associated with ExAblate~     Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.~      Effectiveness:~      To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID~     in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia~     (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months~     and 12-Months post-ExAblate treatment.~   "
54233|NCT02347241|"~     The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation~     Edu-cation intervention (INSPIRE-D) improves process of care associated with improved~     newborn survival and neurologic outcomes.~   "
54234|NCT02347228|"~     The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and~     to evaluate pharmacokinetics (PK), safety/ tolerability and - preliminary efficacy of OB318~     in patients with advanced solid malignancies.~   "
54235|NCT02347215|"~     Serial assessment of angina status and ischemia on stress echo over one year among patients~     with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.~   "
54236|NCT02347202|"~     A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling~     and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The~     NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides~     counseling and support for families involved in the care of a relative or friend with~     Alzheimer's Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially~     reduced caregiver's depressive symptoms, improved their physical health, and extended the~     time persons with ADRD remained at home by an average of 1.5 years (Mittelman et al.,~     AG14634, formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889).~      The intervention is now being widely implemented in-person, but there are barriers that~     prevent many caregivers from receiving its benefits, including geographic distance;~     impediments to older adults leaving their homes; and travel considerations for counselors~     which make it impossible to provide the NYUCI in person.~      The goal of this study is to evaluate the efficacy of an online videoconferencing version of~     the NYUCI. This innovative application has massive implications for social service delivery~     to older adults, because it will make it possible to deliver an in-person intervention, via~     the internet, which is already evidenced based to older adult caregivers who cannot~     currently be served. It will create the online reservation and management technology linking~     counselors with families as well as the evidence of effectiveness of providing such services~     via secure video teleconferencing vehicles. The proposed Telehealth Technology for Distance~     Counseling (TTDC) and related online educational training modules will connect skilled~     providers to the families of persons with dementia without regard to geographic location.~     Implications for rural healthcare delivery are particularly persuasive. To the investigators~     knowledge, this will be the first large-scale TTDC to be developed and rigorously tested~     with a randomized controlled trial. The investigators hypothesize that such a system,~     coupled with online training for providers and families on tele- counseling and distance~     caregiving, will have similar benefits to those achieved with in-person counseling during~     the original NYUCI RCT.~      This project includes an online reservation and management technology linking counselors~     with families via secure videoconferencing vehicles. The Telehealth Technology for Distance~     Counseling (TTDC), and online technology developed as part of this overall effort, will~     connect skilled providers to the families of persons with dementia without regard to~     geographic location. The related online clinical modules (i.e., interactive, computer-based~     educational materials) developed as a part of this grant effort will prepare counselors to~     provide the intervention, and caregivers to utilize the internet software, to be able to~     participate in counseling.~      The TTDC will include a scheduling system to link counselors to families at their mutual~     convenience and assure delivery in a cost-effective manner. The TTDC has the additional~     potential to transform ADRD care in ethnic and culturally diverse communities by connecting~     highly trained NYUCI counselors with specialized language and cultural skills to families~     who would not have access to these resources locally.~      In this study investigators will have 240 caregivers navigate the online educational module~     and the online reservation system for connecting caregivers with social workers. Half of the~     caregivers will then be paired with social service providers to receive counseling over the~     telephone, and the other half with be paired with social service providers to receive~     counseling via Zoom, a video conferencing program. Recruiting across the United States and~     Toronto, Canada.~   "
54237|NCT02347189|"~     Non-randomized, multi-center, prospective surveillance study to investigate and assess the~     residual risks, and to confirm the currently established safety and performance of the~     Melody TPV PB1016.~   "
54238|NCT02347176|"~     The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with~     atopic dermatitis~   "
54239|NCT02347163|"~     Recent evidences suggest that zoledronate (zol), one of the most used bisphosphonates (BPs)~     in the clinical setting for the prevention and treatment of bone metastasis in cancer~     patients, may have antitumor activity in early breast cancer in terms of improved disease~     free survival, overall survival and better response in BPs treated patients. BPs are~     mevalonate pathway inhibitors and one of the most intriguing hypothesis supporting their~     anticancer activity relies on the modulation of the mevalonate downstream metabolism.~     Biologically active mevalonate metabolites are involved in tumour cell proliferation and~     invasion and selected cancer subtypes may present a more pronounced mevalonate activity,~     able of maintaining an aggressive phenotype. The mevalonate pathway has deep impact on the~     function of YAP/TAZ, transcriptional regulators of tumour growth, and preclinical evidences~     suggest that BPs are able to interfere with YAP/TAZ expression, via mevalonate pathway. This~     study addresses the clinical role of BPs in triple negative breast cancer (TNBC) patients~     selected by the level of mevalonate pathway regulation, namely the p53 expression. This~     study is a multicenter single-arm, phase II study primarily aimed at assessing the~     anti-tumor activity of pre-operative zol measured through its effect on the Ki67~     proliferative biomarker, in TNBC patients classified according to the p53 expression (high~     vs low p53 expression). Patients with newly diagnosed, untreated, operable TNBC, intended to~     definitive breast surgery and suitable for pre-operative therapy with zoledronate will~     receive a pre-operative, single administration of zol (4mg i.v.), 7 days before definitive~     breast surgery. Ki67 levels will be assessed in tumor samples collected at the time of~     diagnosis and after zoledronate treatment at the time of definitive surgery. The secondary~     objective of the study is to investigate the effect of zoledronate on critical~     genes/proteins related to p53 and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed in the~     tumor tissue collected at the time of diagnosis and at definitive surgery. Zol safety~     profile will be evaluated by the NCI-CTCAE scale, version 4.0, and by the occurrence of~     serious adverse reactions. The total number of patients required is forty. The overall~     duration of the project is 32 months (30 months for accrual, followed by 2 months of~     follow-up after the recruitment of the last patient).~   "
54240|NCT02347150|"~     Several patients die in the intensive care unit (ICU) due to their acute disease and~     comorbid conditions. Moreover, after ICU discharge, some ICU survivors still die in the~     wards.~      Previous studies have shown that the clinical condition of the patient at the time of ICU~     discharge may influence in-hospital prognosis. Non-modifiable factors, such as age and~     comorbid conditions certainly play a role. But inflammatory status (especially C-reactive~     protein - CRP), Sequential organ failure score (SOFA) score and Therapeutic intervention~     scoring system (TISS) 28 score have also been related with the risk of hospital death.~      Admission to a high dependency unit may reduce the ICU length of stay (LOS). This strategy~     may also help to improve prognosis contributing to further stabilize the patient, facilitate~     his autonomy and the removal of invasive devices. However the benefit of a step-down~     strategy (from ICU to a high dependency unit) has never been evaluated.~      The development of a score to evaluate the risk of patients discharged from the ICU may help~     to improve the allocation of resources, either to prolong the ICU stay, or admission to a~     high dependency units or the ward.~   "
54241|NCT02347137|"~     As the loss of muscle mass with aging is associated with a dysregulation of muscle protein~     synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients,~     the primary outcome of the trial is to investigate the effect of a mixed macronutrient~     beverage on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may~     be predominantly influenced by the contractile activity of skeletal muscle; for example, the~     investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step~     count) induces anabolic resistance in otherwise healthy older adults. In contrast,~     resistance exercise is well-known to enhance muscle mass and can increase the sensitivity of~     skeletal muscle to dietary amino acids. Therefore, all participants will undergo a 2-week~     reduced step count intervention combined with a unilateral leg resistance exercise protocol~     to induce an 'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or~     'anabolically sensitive' leg, respectively; this within subject model will be utilized to~     investigate the effect of the mixed macronutrient beverage in both relatively 'healthy' and~     'unhealthy' older muscle. The investigators will also measure changes in muscle mass, muscle~     function, and cardiovascular health of both legs before and after the 2-week intervention to~     determine the effect of reduced activity and the protective effect of minimal, low-intensity~     exercise on these outcomes.~   "
54242|NCT02347124|"~     The current study will test the effectiveness of a multi-modal behavioral intervention (the~     Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking~     services through tobacco quitlines.~      The investigators hypothesize that, compared to people in the control arm, participants in~     the enhanced intervention will:~        1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates~          at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].~        2. Be more likely to see a dental care professional in the past 6 months at 6 month~          follow-up [primary outcome] or at least be more likely to have scheduled a future~          appointment [secondary outcome].~        3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes~          (e.g., self-efficacy, motivation) that could influence future behavior change.~   "
54243|NCT02347111|"~     In this pilot and feasibility study, the investigators will enroll patients with frequent~     symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different~     classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide~     preliminary data for a larger study in which the investigators will test the hypothesis that~     a common AF genetic risk allele modulates response to different AADs.~   "
54244|NCT02347098|"~     The purpose of this randomized, multi-site, clinical trial is to determine whether intensive~     therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood~     of low-density lipoprotein (LDL) cholesterol is more effective than statin therapy alone in~     reducing plaque volume in heart arteries of patients who have already suffered an acute~     coronary syndrome (ACS). The study will also investigate whether this intensive approach can~     help increase the presence of endothelial progenitor cells (EPC), stem cells that have been~     shown to reduce CV events in ACS patients. This study has two phases and FDA approval for~     phase II has been received and all information has been updated to reflect PREMIER Phase II.~   "
54245|NCT02347085|"~     Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover~     Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe~     COPD after 4 Weeks of Treatment with PT003 and Placebo MDI~   "
54246|NCT02347072|"~     Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover~     Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe~     COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium~     Bromide) as an Active Control, and Placebo.~   "
54273|NCT02346721|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) administered for 12 weeks in~     participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection that previously~     participated in the Gilead-sponsored study GS-US-342-1138.~   "
54247|NCT02347059|"~     Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment~     for patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic~     drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose.~     However, a considerable variation in the extent of dopaminergic drug reduction has been~     reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however,~     there are no formal studies examining which type of antiparkinsonian medication may be more~     effective and/or better tolerated following STN DBS.~      Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy~     versus DAs monotherapy after STN DBS over a 3-month follow up period.~      This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and~     DAs monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly~     assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients~     for each study arm). Treatment assignment will be unmasked for the patient but will be~     blinded for the neurologist programming DBS and evaluating the patient. Another neurologist~     will be in charge of medication adjustments. Primary outcome is the change in severity of~     non-motor symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up~     visit after surgery.~      In spite of an improvement of the motor condition many patients develop apathy and~     depression following surgery (Neurosurgery in Parkinson's disease: the doctor is happy, the~     patient less so). This study will shed light on the best way to manage patients after STN~     procedure, thus contributing to a further improvement of the surgical outcome in a~     population of young and motivated patients (those commonly receiving STN DBS), eventually~     bringing them closer to a normal personal and social life.~      Results of our study may provide new insights in the management of advanced PD after STN~     DBS, further leading to development of future larger trials.~   "
54248|NCT02347046|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety~     after single oral administration of FYU-981 to subjects with renal insufficiency and with~     normal renal function.~   "
54249|NCT02347033|"~     Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs~     people's functioning. It is often chronic and may be accompanied by depression and other~     anxiety disorders. It is not currently clear whether medication or psychological therapy~     provides better long term outcomes for those not responding to simpler low intensity~     treatments so we propose to compare the clinical effectiveness of a pharmacological~     treatment (the drug Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.~      Our hypothesis is that in people with GAD who have not responded to low intensity~     psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as~     measured using the GAD-7 scale at 12 month follow-up than Sertraline.~   "
54250|NCT02347020|"~     This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral~     pattern, with equal sleep duration, will promote positive energy balance and insulin~     resistance (IR).~   "
54251|NCT02347007|"~     The purpose of this study is to determine whether introducing almonds into the diet of~     overweight and obese Blacks and Hispanics improves body composition, decreases liver fat,~     and lowers cardiovascular disease profile.~   "
54252|NCT02346994|"~     The purpose of this study is to compare the effects of a cooking oil on metabolic rate,~     appetite, and metabolic risk markers.~   "
54253|NCT02346981|"~     The purpose of the present study was to analyze the effect of 12 weeks of resistance~     training on post-exercise blood pressure (BP) and to to correlate the acute and chronic~     decrease in blood pressure (BP) following resistance training in normotensive older women.~     Twenty-eight older women were randomly assigned to a training group (TG) or to a control~     group (CG). The TG underwent a resistance training program (8 exercises, 2 sets, 10-15~     repetitions), while the CG performed stretching exercises (2 sets, 20 s each, 2~     nonconsecutive days/week). Both groups performed the intervention for 12 weeks. At baseline~     and after intervention the subjects were submitted to two sessions: resistance exercise~     session and control session. In these sessions, BP was obtained in pre and post-sessions.~     Rest blood pressure were also measure at baseline and after 12 weeks of intervention.~   "
54254|NCT02346968|"~     Established markers of kidney function, such as creatinine, have considerable limitations in~     the diagnosis of delayed graft function (DGF) after kidney transplantation (KT). Indeed,~     creatinine does not accurately reflect minor changes of renal function as its levels change~     only upon significant fluctuations of the latter. CAF22 is a molecule which arises from the~     degradation of a larger protein and it is proposed to be a reliable and more sensitive~     marker of renal function. This study aims to further clarify this issue by measuring blood~     and urine concentrations of CAF22 and comparing them with creatinine levels before and after~     KT.~      The main assumption is that blood CAF22 levels could serve as a more sensitive kidney~     function biomarker than creatinine post-KT to detect DGF.~   "
54255|NCT02346955|"~     The purpose of this study is to evaluate the safety and tolerability of humanized IgG4~     (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered~     intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in~     participants with selected advanced or recurrent malignancies. Escalating multiple doses~     will be evaluated to determine the recommended dose for Phase 2 clinical studies.~   "
54256|NCT02346942|"~     The Primary objective of this study is to understand the rheumatoid arthritis (RA)~     population in national integrated delivery network who are treated with first- or~     second-line biologic disease modifying anti-rheumatic drug (bDMARD) therapy (with or without~     Methotrexate) and to evaluate switching patterns and reasons for switching to another~     bDMARD.~   "
54257|NCT02346929|"~     The purpose of this study is to determine the efficacy of ultrasound guided hematoma block~     versus traditional blind hematoma block for analgesia in distal radius fracture reduction.~   "
54258|NCT02346916|"~     The purpose of this study is to determine whether there is a positive correlation between~     the ability to sense chest pain in the context of myocardial ischemia and the ability to~     sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the~     active ingredient on hot chili peppers).~   "
54274|NCT02346708|"~     This study plans to learn more about the brain function related to thinking problems in~     individuals with Parkinson's disease.~   "
54275|NCT02346695|"~     Impaired myocardial deformation may determine cardiac diastolic dysfunction. The~     investigators will investigate the vascular determinants of myocardial deformation and~     twisting-untwisting and their interrelation with exercise capacity in patients with~     untreated arterial hypertension~   "
54399|NCT02345070|"~     Primary Objective:~      To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597~     administered subcutaneously during 52 weeks on lung function of patients with Idiopathic~     Pulmonary Fibrosis (IPF).~      Secondary Objectives:~      To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease~     progression.~      To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with~     IPF.~   "
54259|NCT02346903|"~     The purpose of this study is to determine whether there is a positive correlation between~     the ability to sense chest pain in the context of myocardial ischemia and the ability to~     sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the~     active ingredient on hot chili peppers). Patients undergoing clinical elective balloon~     angioplasty of a coronary stenosis will be asked to quantify the subjective intensity of any~     chest pain they feel during a standardized episode of myocardial ischemia produced by a~     one-minute coronary balloon occlusion, using a previously-validated numeric rating scale.~     The same patients will subsequently be asked to grade the subjective intensity of cutaneous~     discomfort resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an~     over-the-counter product approved for topical application to treat muscle and joint aches)~     to the forearm. The goal will be to determine whether an association can be demonstrated~     between the subjective perception of ischemic chest pain during coronary balloon occlusion~     and cutaneous capsaicin sensitivity. Such an association could have considerable clinical~     value, as it might allow physicians to prospectively assess an individual's ability to~     perceive myocardial ischemia/infarction by assessing his/her subjective response to the~     topical application of capsaicin.~   "
54260|NCT02346890|"~     The study is designed to evaluate safety, tolerability, pharmacodynamics and~     pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.~   "
54261|NCT02346877|"~     This study will evaluate whether the effect of personalized patient counselling tool,~     Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines~     Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in~     subjects with rheumatoid arthritis over the historical control as estimated by the standard~     of care.~   "
54262|NCT02346864|"~     The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on~     the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.~   "
54263|NCT02346851|"~     Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators~     use functional electrical stimulation in posterior deltoid and supraspinatus for prevention~     and treatment. But the investigators hypothesis self triggered myoelectric stimulation~     system has more effective for shoulder subluxation. The purpose of this study is to compare~     post-stroke shoulder subluxation treatment FES and triggered FES.~   "
54264|NCT02346838|"~     Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week~     feeding study in which they will randomized to receive either 10 g/day of inulin or placebo.~     All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,)~     controlled for micronutrient content for 6 weeks to avoid the potential confound of~     individual differences in diet on gut microbiota. Measurements of intestinal permeability,~     insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and~     following the controlled feeding period. Stool samples will be collected to assess gut~     microbial communities.~   "
54265|NCT02346825|"~     The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of~     Health that is examining the the use of constraint-induced movement therapy (CIMT) for~     infants and toddlers as a effective treatment, since there have been no randomized control~     trials (RCT) for the age range as well as monitor the stress levels as related by~     self-report of parents or biological indicators. Infants and toddlers who meet study~     eligibility requirements at one of the three clinical sites (Charlottesville, VA, Columbus,~     OH, and Roanoke, VA) will be invited to enroll, and their parents will be provided all~     necessary paperwork along with informational documentation.~   "
54266|NCT02346812|"~     Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3~     weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of~     typical American foods and will be free of Brassica vegetables and free of glucosinolates~     and isothiocyanates. The Brassica diet will contain the control diet plus~     glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between~     study periods. Blood, urine, and fecal samples will be collected at the end of each study~     period. Eligible participants will be selected based on genotype for glutathione~     S-transferase (GST), which has been shown to influence the potential protective role of~     dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half~     (n=9) will have the GSTM1-null genotype.~   "
54267|NCT02346799|"~     The purpose of this study is to determine whether healthy habits can be formed more~     effectively when people are rewarded for repeated engagement in a given healthy behavior at~     a specific, routinized time each day rather than at any time.~   "
54268|NCT02346786|"~     sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of~     good hydration, including days without training or competition could prevent their~     occurrence~   "
54269|NCT02346773|"~     Currently, there is considerable interest in the possibility that dietary supplementation~     with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain~     development. Epidemiological and clinical studies support the idea that relative~     disappearance of omega-3 diet from the diet in developed countries has been linked with~     increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive~     impairment, motor dysfunction and visual acuity problems. It is further known that families~     with lower socioeconomic status may have poorer diet and, consequently, may not realize~     their full potential regarding their cognitive abilities. The aim of this project is to~     evaluate effectiveness of a diet intervention rich in omega-3 acid in healthy children~     9-to-12 years old from less well-off families.~   "
54270|NCT02346760|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a~     single subcutaneous dose of UB-621 in healthy volunteers.~   "
54271|NCT02346747|"~     This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of~     maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV~     high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary~     peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil~     prepared and stored from ovarian tumor cells obtained at the time of primary surgical~     debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture~     must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of~     placebo doses will manufactured. Subjects will have achieved a clinically defined complete~     response following primary surgery and adjuvant chemotherapy.~   "
54276|NCT02346682|"~     There is heterogeneity in patients with depression. Many scholars propose that~     individualization of antidepressant achieves better outcomes. However, the scientific~     theoretical basis of individualized treatment is still quite weak. Different clinical~     subtypes of depression and their possible biomarkers are critically needed to provide the~     individualization with theoretical base. Diagnostic types of major depression disorder (MDD)~     based on the Theory of Traditional Chinese Medicine (TCM) and possible differentiations in~     neurobiochemistry, metabonomics and neuroimaging could be one of ways to explore the~     biomarkers and support the theory of the individualized treatment.~      The hypothesized results will be of help to clarify the biological basis of MDD with LDQS~     and with DBHS, to provide the TCM with further scientific evidence, to explore the~     pathogenesis of depression, to improve the objective diagnosis of depression, and to promote~     targeted interventions by Western medicine, TCM or both.~   "
54277|NCT02346669|"~     The incidence of obesity has dramatically increased during the last three decades, leading~     to a significant increase of obesity-related morbidity, including type 2 diabetes mellitus~     (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese~     patients may be treated by medications or by bariatric surgery. Both alternatives have~     limitations due to incomplete resolution of the diseases, high cost or potential procedural~     related morbidity. An increasing body of evidence points to a role of the enteric microbiota~     in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut~     microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human~     gut germs, demonstrated special interactions between the gut microbiota and the host,~     creating a typical microbiota composition which changes significantly following diet change~     from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid~     alternations in the microbiota composition has also shown in humans, after changing from~     western to high fiber diet. A change in diet life style may lead to an improvement in T2DM~     symptoms such as decrease in visceral adipose tissue.~   "
54278|NCT02346656|"~     15-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic post surgical groin pain~   "
54279|NCT02346643|"~     11-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     intractable, chronic pain~   "
54280|NCT02346630|"~     Stroke is the leading cause of acquired long-term disability in adults in developed~     countries. Despite aggressive rehabilitation, lasting upper extremity impairment remains in~     the majority of stroke survivors. It is hypothesized that enhancing neuroplasticity through~     the combination of drug therapy and physical therapy could enhance outcomes for stroke~     survivors. The combination of levodopa and intensive physical therapy shows promise in~     enhancing the functional motor recovery of stroke patients during the sub-acute and chronic~     period without reported significant side effects. Robotic-aided training is a promising tool~     that has the potential to deliver high-intensity, task-oriented, reproducible therapy that~     can decrease the burden on a therapist. Since the evidence behind dopaminergic potentiation~     of neuroplasticity and stroke recovery is promising, it is the investigators aim to combine~     dopaminergic drug therapy with highly intensive robotic-assisted therapy to provide superior~     upper extremity functional recovery over traditional stroke rehabilitation.~   "
54281|NCT02346617|"~     To evaluate the safety and efficacy for treatment of persistent CMV infection in~     hematopoietic cell transplant (HCT) recipients.~   "
54282|NCT02346604|"~     People with mild chronic obstructive pulmonary disease (COPD) can have significant~     physiological abnormalities and breathing inefficiency which become more pronounced during~     the stress of exercise, leading to intolerable breathing discomfort (dyspnea). To better~     understand the mechanisms of respiratory symptoms and exercise limitation in mild COPD, we~     will examine detailed lung function tests and other important measurements during rest and~     exercise in people with mild COPD compared with healthy non-smokers. This will be the first~     study to uncover the fundamental causes of breathing inefficiency and the related shortness~     of breath during physical exertion in patients with mild COPD. We hope to demonstrate that~     one simple measurement during exercise [the relation (ratio) between the total amount of air~     breathed (ventilation) and the amount of carbon dioxide breathed out] gives meaningful~     information about the extent of damage to the small airways and blood vessels in mild COPD~     and the overall gas exchanging function of the lungs, without the need for an arterial blood~     sample.~      This is a case-controlled observational study not involving an intervention. Participants~     will complete 2 visits approximately 1 week apart, each conducted at the same time of day.~     Visit 1 will consiste of screening for iligibility, symptom and activity assessments,~     pulmonary function tests and an incremental cycle cardiopulmonary exercise test (CPET) for~     familiarization purposes. Visit 2 will include spirometry followed by an incremental cycle~     CPET with detailed measures of ventilatory, gas exchange, sensory-perceptual and arterial~     blood gas responses.~   "
54283|NCT02346591|"~     The investigators developed a responsive mobile-web app, Jauntly, which was designed to~     take advantage of the known connections between positive emotions, stress reduction and~     stress resilience. The app's goal was to lead users through research-proven positive~     emotion-enhancing exercises and relevant educational materials. Intervention activities~     covered five well-being-generating content areas: 1) promoting the experience and~     recognition of gratitude; 2) encouraging positive social relationships and feelings of~     social support; 3) improving stress resilience via mindfulness and other relaxation-focused~     activities; 4) focusing and capitalizing on individual strengths (as opposed to limitations~     and weaknesses); and 5) general positive mood inducing activities. Program content was~     adapted from a variety of stress-relevant research areas including health~     psychology/psychosomatic medicine, social/personality psychology, positive psychology, and~     clinical psychology.~   "
54284|NCT02346578|"~     The objective of this study is to compare the efficacy and safety of enzalutamide or~     alternative AA therapy in CRPC participants who were previously treated with a combined~     androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of~     enzalutamide and alternative AA therapy will be evaluated, and effective therapy against~     CRPC after treatment with Bic-CAB will be investigated.~   "
54315|NCT02346175|"~     The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in~     Type 2 diabetes mellitus patients.~   "
54285|NCT02346565|"~     The overall question the investigators would like to help answer is whether SE with or~     without MCE data can be widely used as a first line investigation in women with no previous~     history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In~     order to answer this question the investigators will look at the following:~      i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of~     CAD?~      ii) What is the additive value of myocardial perfusion data to wall motion data for~     predicting significant CAD on angiography and future cardiac events in women?~      iii) What is the additive value of Carotid ultrasonography in a large population of women~     referred for stress testing?~   "
54286|NCT02346552|"~     The main objectives of this study are to evaluate the ease of use and performance of the~     AutoLap system compared to human camera holder during general and bariatric laparoscopic~     surgeries.~   "
54287|NCT02346539|"~     The investigators will determine whether an acute dose of nicotine, in the form of the~     nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in~     individuals with major depressive disorder.~   "
54288|NCT02346526|"~     The purpose of this study is to look for markers of how Ra-223 improves the lives of men~     with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but~     adds non-standard testing in an attempt to gain insight about how the drug works and how~     best to track patients who are receiving the drug.~   "
54289|NCT02346513|"~     Primary objectives:~        1. To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion~          concentration) in patients that received the Ceramic on Metal arthroplasty of hip and~          who have well functioning primary total hip arthroplasties during short and medium-~          term follow up time points.~        2. To compare blood ion levels of patient that received COM arthroplasty with the blood~          ion levels of patient receiving non-COM standard total hip arthroplasty (a Metal on~          polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and~          medium-term follow up time points .~      Secondary Objective:~      1) To determine whether these blood levels correlate with any device specific factors such~     as: component position, size and type, wear rate and/or patient specific factors such as~     gender, body mass index, age and activity level.~   "
54290|NCT02346500|"~     Benign prostatic hyperplasia (BPH) is a major cause of lower urinary tract symptoms (LUTS)~     affecting aging men. Medical therapy for BPH includes alpha adrenergic blockers and~     5α-reductase inhibitors. In men with moderate-severe LUTS due to BPH, surgical therapy~     should be considered for 1) those who failed medical therapy and/or 2) those with refractory~     urinary retention, renal insufficiency secondary to BPH, recurrent urinary tract infections~     (UTI's), or bladder stones. The gold standard for the surgical therapy of BPH has been~     transurethral resection of the prostate (TURP). However, TURP is associated with significant~     comorbidities such as bleeding, prolonged catheterization, and absorptional hyponatremia. To~     minimize these problems associate with TURP, alternative minimally invasive treatment~     techniques have been developed. Two of the most commonly used treatment modalities include a~     photoselective laser vaporization of the prostate (GreenLight PVP) using the potassium~     titanyl phosphate (KTP) laser and holmium laser enucleation of prostate (HoLEP). The major~     problem in all these minimally invasive treatment modalities is that they are generally~     associated with a higher retreatment rate. In addition, there is no intraoperative and~     objective measurement, other than a limited, transurethral visualization of the prostatic~     cavity, to assess the extent of the vaporization or enucleation.~      We propose to use the transrectal ultrasound (TRUS) and a novel robot, the TRUS robot, to~     hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation~     of the prostate gland intraoperatively. TRUS has been extensively used for the biopsy needle~     guidance during prostate biopsy. However, it has never been used during transurethral~     prostate procedure. The TRUS Robot has been used safely in the current clinical trial,~     NA_00027540, Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical~     Prostatectomy. We would like to study the feasibility and safety of using TRUS and the TRUS~     Robot to monitor the minimally invasive treatment of BPH, such as GreenLight PVP.~   "
54291|NCT02346487|"~     The study will be carried out to provide supportive clinical data on the feasibility,~     efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be~     based on the existing LPV/r pellets which already represent a clear advantage in comparison~     with the liquid formulation.~   "
54292|NCT02346474|"~     Background:~      - It is important for doctors to know how much fat a person has in his or her body. Machines~     called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this~     study have a new DXA machine, and they want to know if it measures body fat as well as the~     old machine. They also want to see how body fat readings from the new DXA compare to~     readings from a magnetic resonance imaging (MRI) scan.~      Objectives:~      - To see if two DXA machines give the same results when measuring body fat. Also, to know~     whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.~      Eligibility:~      - People 18 years and older who weigh less than 350 pounds.~      Design:~        -  Participants will be screened with a medical history and physical exam. Women will have~          a pregnancy test. Researchers will make sure participants are able to have an MRI if~          they volunteered to.~        -  Participants will have their body fat measured by each DXA scanner. They will lie~          quietly on a padded table while being scanned. The scan uses X-rays to take pictures of~          the body. Both scans will be done on the same morning and will take 10-15 minutes on~          both machines.~        -  Some participants also will have their body fat measured with MRI. They will lie in a~          long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to~          take pictures of internal organs. Participants will sign an additional consent form for~          this procedure.~   "
54293|NCT02346461|"~     Background:~      - People with GNE myopathy have muscle weakness and can have difficulty walking . The~     disease comes from a gene mutation related to the production of a sugar called sialic acid.~     Researchers think decreased sialic acid may cause the muscle problems. Researchers are~     testing the drug DEX-M74 (also known as ManNAc) which is a building block of sialic acid. It~     is a powder that is dissolved in water.~      Objective:~      - To evaluate the safety of 90 days of DEX-M74 given by mouth.~      Eligibility:~      - Adults ages 18 60 diagnosed with GNE myopathy.~      Design:~        -  Eligible participants will be admitted to the NIH Clinical Center for the first visit~          and will stay 10 14 days. Participants will have:~        -  Medical history and physical exam~        -  Electrocardiogram to measure heart function~        -  Blood and urine tests~        -  Muscle strength tests~        -  Magnetic resonance imaging (MRI) muscle scans. Participants will lie on a table that~          slides in and out of a metal tube that takes pictures~        -  Questionnaires~        -  Muscle biopsies. Samples of muscle will be taken, one each from the arm and leg.~        -  The study drug as a liquid twice a day~        -  Participants may wear a small activity monitor throughout the study. It can be worn on~          a waistband.~        -  After discharge from the initial visit, participants will take the study drug at home.~          Participants will need to record if they miss any doses.~        -  Visit 2 will be at 6 weeks for 1 2 days of medical evaluation. Blood samples will be~          drawn.~        -  Visit 3 will be at the end of the study. Participants will stay in the NIH Clinical~          Center for 5 6 days for medical evaluations, muscle tests, and scans. Another muscle~          biopsy will be taken. Blood samples will be drawn.~        -  Participants will be contacted by telephone or email about 4 times after leaving the~          clinic.~   "
54486|NCT02343952|"~     This is an open label, multi-institutional, single arm phase II trial of consolidation~     therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in~     patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or~     blinding is involved.~   "
54294|NCT02346448|"~     One of the major elements of successful endoscopic retrograde cholangiopancreatography (~     ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various~     factors may adversely affect the cannulation procedure of the CBD leading to complications~     (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic~     sphincterotomy is frequently required for interventional procedures (eg stone extraction).~     During sphincterotomy, incision of the orifice of the papilla will be performed by using a~     sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of~     acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the~     papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can~     be performed. As a result, bleeding complications and scarring as late effects might be~     prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP~     when using a balloon catheter.~      This study aims to evaluate the incidence of acute pancreatitis and other complications~     after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic~     sphincterotomy in a randomized multicenter setting.~   "
54295|NCT02346435|"~     Retrospective studies indicate that active surveillance for clinically localized, small~     renal masses (cT1a, <=4cm) is safe. It is our hypothesis that active surveillance is safe~     and efficacious when compared prospectively to patients undergoing immediate intervention~     for their small renal mass.~   "
54296|NCT02346422|"~     The purpose of this trial is to characterize the safety profile and preliminary activity of~     high-dose MYDICAR® in persons with advanced heart failure when added to their maximal and~     optimized therapy.~   "
54297|NCT02346409|"~     Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of~     postural tremor of the upper limbs that impairs most of the manual activities of every day~     life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not~     fully elucidated, tremor is associated with abnormal activity within different brain~     regions, in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the~     ventral intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but~     is an invasive procedure. Transcranial stimulation of the cerebellum may represent a~     non-invasive therapeutic option for ET patients. Here, the investigators propose to test the~     efficacy of cerebellar stimulation in 15 ET patients previously operated for DBS of the~     thalamus. To further understand how this treatment provokes tremor reduction, the~     investigators will analyse the brain neuronal activity in 13 others ET patients candidate to~     thalamic DBS by using combined electrophysiological recordings of the thalamus (with the~     electrodes implanted), the cerebellum and the cortex with magnetoencephalography.~   "
54298|NCT02346396|"~     The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic~     pain, to estimate the importance and the duration of this effect, and to improve its~     efficiency by the use at home.~      It is established that the repetition of the sessions of cortical stimulation over a week~     improves their analgesic efficacy. However, this effect does not exceed a few weeks and is~     much lower than that of the stimulation implanted surgically. Implanted stimulation operates~     periodically, several times a day, and this repetition of doses , akin to the regular~     taking of a medicine, may explain its longer efficacy for pain relief which, may extend over~     several years (André-Obadia and al 2014).~      No study at this date has estimated the long-term effect of non-invasive stimulation when is~     also periodically repeated on a daily basis, over several weeks.~   "
54299|NCT02346383|"~     To determine the best parameters with various leads to cover back and leg pain and provide~     best pain relief~   "
54300|NCT02346370|"~     A Phase 1b study for subjects with Stage IIIB/IV NSCLC to participate in 1 of 2 portions of~     this study. The first portion is Dose Escalation in which subjects are tested with PEGPH20~     at various doses (1.6, 3.0, 2.2 and 2.8 mcg/kg) in addition to dosing with the standard dose~     of docetaxel of 75 mg/m2 (PDoc) once every 21-day cycle. Based on observations on the safety~     and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0~     mcg/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 mcg/kg. Up to 30~     additional subjects may be enrolled to test these dose levels. The second portion of Phase~     1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in~     dose escalation is administered every 21 days to approximately 50 subjects with high~     hyaluronan (HA-high) prospectively measured in their tumor tissue.~   "
54301|NCT02346357|"~     Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The~     purpose of this study is to investigate the analgesic efficacy of preoperative obturator~     nerve block as measured by postoperative pain scores and postoperative analgesic~     requirements. The primary outcome will be the patient's first reported pain scores in the~     post anesthesia care unit (PACU).~   "
54302|NCT02346344|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
54303|NCT02346331|"~     Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia)~     secondary to severe infection. In high-income countries (HICs), early resuscitation of~     septic patients with protocol-driven therapy, including quantitative fluid administration~     guided by invasive monitoring, has resulted in improved outcomes for septic patients.~     Prevalence and mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than~     in high-income countries; however, most hospitals in SSA lack the technology and resources~     necessary to implement the resuscitation protocols used in HICs and therefore, mortality~     from sepsis remains high. The World Health Organization (WHO) has recently disseminated an~     algorithm for resuscitation of septic patients in low resource settings. This algorithm is~     based on expert consensus only, and its efficacy has never been tested.~      This study will be conducted in the Casualty Department of Moi Teaching and Referral~     Hospital (MTRH) in Eldoret, Kenya.~      The purpose of this study is to describe the epidemiology of patients presenting with severe~     sepsis, to examine the microbiology causing severe sepsis, to describe current management~     and outcomes for severe sepsis, and to test the effect of implementation of the WHO~     resuscitation algorithm at MTRH.~      The study design is a prospective before and after clinical trial. In an initial~     observational phase, adult patients presenting to the MTRH Casualty Department with sepsis~     and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled~     into a prospective observational cohort. Demographic data, medical characteristics, and~     microbiological studies will be obtained, then the management and outcomes of these patients~     will be observed. In a second phase, patients with sepsis will continue to be enrolled into~     a prospective observational cohort, while patients with severe sepsis will be enrolled into~     an intervention group. Patients in the intervention group will be managed according to the~     WHO resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided~     by vital signs and physical exam findings, rapid and early administration of empiric~     antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of~     lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour,~     in-hospital, and 30-day mortality.~   "
54487|NCT02343939|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of~     entospletinib (GS-9973) when administered as monotherapy or in combination with chemotherapy~     in adults with acute myeloid leukemia (AML).~   "
54304|NCT02346318|"~     The randomized controlled multicenter clinical study of compound Kushen Injection to reduce~     the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials，The~     main purpose is to evaluate the effect of compound Kushen Injection in preventing and~     reducing the radiotherapy related adverse reactions. The participants of the clinical trials~     are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group~     of participants is given compound Kushen Injection with chemoradiotherapy, while another~     group is only given chemoradiotherapy. The period of trials is 18 months.~   "
54305|NCT02346305|"~     The effectiveness of NIV is clearly demonstrated but no recent studies describe the~     prescription based on clinical data and the conditions of using NIV at home according the~     various respiratory diseases.~      The investigators' purpose is that a better knowledge of NIV practices could improve both~     the quality to support patients at home and the efficacy of the treatment.~      The main objective of this study is to analyze the clinical data justifying the prescription~     of NIV advice according respiratory disease. The secondary objectives are to study~     comorbidities, treatment failures, survival rate during the study period.~   "
54306|NCT02346292|"~     The study is an observational multicenter descriptive study. It is planned to enroll~     approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of~     COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in~     approximately 20-25 institutions of treatment and prevention in Russian Federation and will~     include about 50 to 60 subject at each clinical site.~   "
54307|NCT02346279|"~     The aim of this survey is the evaluation of the responsiveness and the estimation of the~     MCID of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a~     self-rating Patient Reported Outcome questionnaire. This multicenter project uses a combined~     anchor and distribution based approach with multiple anchors to provide a range of MCID~     estimates or a single MCID for the reliable and valid Items, Activity and Participation~     group and the Total Score of the MSQPT, which should to be used as guidelines in daily~     practice.~   "
54308|NCT02346266|"~     A stroke awareness program for school-aged children to learn the signs/symptoms of stroke,~     teach their parents and make healthy life-style choices.~   "
54309|NCT02346253|"~     This phase I/II trial studies the side effects and how well high-dose brachytherapy works in~     treating patients with prostate cancer that has not spread to other parts of the body.~     Brachytherapy is a type of radiation therapy in which radioactive material sealed in~     needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a~     better treatment in patients with prostate cancer.~   "
54310|NCT02346240|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol compared to active comparator and placebo in adults with moderate to~     severe chronic plaque psoriasis.~   "
54311|NCT02346227|"~     1. Introduction Cervical cancer (CC) is a major public health problem in Low-income~          countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the~          estimated number of cases is 3839 per year. (WHO, 2010).~           Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary~          cause for the development of CC. Thus, CC is a disease that is easily preventable~          primarily by vaccination against HPV and secondarily through screening and treatment of~          precancerous lesions of the cervix.~           In LICs, the high incidence of CC is due to both high rates of infection with HPV, a~          failure to initiate and sustain effective screening programs based on cytology and the~          non-availability of vaccination against HPV. These situations highlight the need to~          implement simple and inexpensive screening and treatment methods suitable for LICs.~          These methods include screening by visual inspection of the cervix after application of~          acetic acid (VIA) and treatment with a topical antiviral drug (AV2).~        2. Aims~           This study aims to:~             -  Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of~               the uterine cervix;~             -  Identify HPV genotypes found in Kinshasa;~             -  Determine the cost-effectiveness of an algorithm combining screening by VIA and~               AV2 and that combining VIA and cryotherapy treatment;~        3. Methods After basic training of local health workers on VIA, on collection of cervical~          samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based~          cytology (LBC) and on application of AV2, a screening and treatment program will be~          offered to women aged 25 and older who will give their informed consent.~      All women with lesions on VIA will be randomized into one of two groups to receive either~     treatment by AV2 or placebo.~      All women with lesions on VIA will be monitored and reviewed after two months and after six~     months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and~     reinfection rates).~   "
54312|NCT02346214|"~     The purpose of this study is to develop a novel, highly automated method of gestational age~     estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical~     parameters appropriate for use in low income countries. The specific aims of the proposed~     study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42~     weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of~     ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize~     that the accuracy of the predictive algorithm will be comparable to commonly used measures~     of gestational age dating (±2 days) and have better precision (±14 days) than commonly used~     measures of gestational age dating.~   "
54313|NCT02346201|"~     Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled,~     masked, 6 month, 10-center randomized clinical trial sponsored by National Institutes of~     Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to~     examine the efficacy and safety of methylphenidate as treatment for clinically significant~     apathy in AD participants. ADMET 2 will enroll participants from real world settings such as~     outpatient, nursing home, and assisted living facilities and will examine the effects of~     methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety~     monitoring.~   "
54314|NCT02346188|"~     Lead is negatively linked to nutritional status, behavior and cognition in children. Despite~     extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a~     problem in developed and developing countries. When lead exposure is unavoidable due to its~     pervasive nature, effective means of protecting or disrupting that exposure need to be~     developed. Nutritional interventions are one such option. We conducted a 2x2 factorial,~     placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed~     children in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity~     to a lead smelter and first-graders were individually randomized to daily treatment with 30~     mg iron, 30 mg zinc, both, or placebo. In addition to biochemical indicators, cognitive~     functions and behavior were evaluated at baseline, after the 6-month supplementation period,~     and again after another 6 months (without supplementation).~      At baseline, 602 children ages 6.2-8.5 years were enrolled.~   "
62887|NCT02234115|"~     The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of~     subjects with advanced prostate carcinoma, when administered as two injections six months~     apart.~   "
54316|NCT02346162|"~     The US obesity epidemic is being transmitted to the next generation. Growing evidence~     suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during~     pregnancy, are associated with increased risk of pregnancy-related complications such as~     gestational diabetes and pre-eclampsia, and an increased risk that her child will become~     obese and face obesity-related health issues in later life.~      Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index~     (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies~     of obese women who start a weight-management intervention program at 14 to 15 weeks of their~     pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic~     programming begin early in the first trimester, well before the first prenatal visit.~     Therefore, waiting to address mothers' weight, physical activity, and diet quality until the~     first prenatal visit is not optimal. Given the need to reach overweight and obese women~     prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on~     observational studies, that women should reach a healthy weight before conceiving, this~     randomized clinical trial will evaluate a comprehensive preconception weight loss program.~   "
54317|NCT02346149|"~     Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar~     levels in the blood. Although diabetic nephropathy is widespread, its underlying~     pathophysiological mechanisms remain poorly understood and, so far, little progress has been~     made to prevent the development of diabetic nephropathy and to delay kidney functions~     decline.~      Increasing amount of data based on animal studies support the pathogenic role of tissue~     hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level~     Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure~     cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two~     cross-sectional clinical studies, we have recently found a positive correlation between high~     circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This~     discovery suggests that an increase in glycemia might acutely decrease renal tissue~     oxygenation.~      The goal of this study is to investigate the impact of serum glucose on renal tissue~     oxygenation in healthy subjects and subjects with glucose intolerance.~   "
54318|NCT02346136|"~     The proposed study will determine whether Tai Chi is an effective and practical intervention~     to improve overall function and lower health care costs in an expensive, vulnerable~     population of seniors that is more representative of many US communities than those~     previously studied. If the results are favorable, our study will also provide the necessary~     training and protocol manuals to replicate Tai Chi programs in senior housing facilities~     across the nation to help prevent, better manage, and overcome frailty among seniors.~   "
54319|NCT02346123|"~     The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1~     (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine~     signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination~     of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.~   "
54320|NCT02346110|"~     This study focuses on optimizing the postoperative pain treatment after major foot and ankle~     surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently~     used single shot saphenous block only covers half of the pain intensive period from the~     saphenous territory, which results in a sharp, break-through pain requiring opioids. The~     hypothesis is that this protracted mixture will keep the patients free of pain without the~     use of opioids for the entire pain intensive period and thus increase rehabilitation and~     patients' satisfaction.~   "
54321|NCT02346097|"~     The purpose of this study is to investigate if optimal electrical resynchronization~     achieved by targeting left ventricular lead placement to the myocardial region with the~     latest electrical activation combined with post-implant pacemakersettings for narrowing the~     paced QRS width causes an excess improvement in the pumping function of the heart (the left~     ventricular ejection fraction) in Cardiac Resynchronization Therapy (CRT)~   "
54322|NCT02346084|"~     The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of~     maraviroc gel following rectal and vaginal administration. The study also includes oral~     exposure to maraviroc.~   "
54323|NCT02346071|"~     Background:~      An increasing number of adolescents report recurrent functional somatic symptoms. Some~     experience persistent symptoms and may receive functional somatic syndromes (FSS) diagnoses~     (i.e. symptoms not attributable to any known conventionally defined physical disease),~     characterised by severe disability and reduced quality of life.~      The aim of this study is to:~        1. Develop an Acceptance and Commitment Therapy (ACT)-based group intervention for~          adolescents with severe FSS (conceptualized as Bodily Distress Syndrome (BDS), see~          detailed description).~        2. Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe~          FSS.~      The ACT-based treatment, with 9 sessions of group therapy and one follow up meeting is~     compared to standard treatment/enhanced usual care, which is one single advisory~     consultation.~      The study includes approximately 120 patients.~   "
54324|NCT02346058|"~     Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency~     or varicose veins combine superficial vein thrombophlebitis.~   "
54325|NCT02346045|"~     A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have~     been developed to treat hypertension properly and reduce cardiovascular risk.~      B. However, there is a subgroup of hypertension which are resistant to treatment.~        1. Resistant hypertension is associated to sympathetic hyperactivity~        2. Renal sympathetic nerve is known to be associated with systemic sympathetic activity~        3. According to research of recent years, catheter based renal sympathetic denervation is~          a safe and effective treatment modality to treat resistant hypertension C. Resistant~          hypertension is observed in end stage renal disease (ESRD) frequently.~      D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal~     sympathetic denervation is expected to improve resistant hypertension in ESRD patients~      F. The aim the present study is to evaluate the effects and safety of catheter based renal~     sympathetic denervation on resistant hypertension in ESRD~   "
54326|NCT02346032|"~     Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary~     tract adenocarcinoma~   "
54327|NCT02346019|"~     The purpose of our study is to improve the fit and function of prosthetic sockets for above~     the knee amputees through the use of an outpatient thigh reduction surgical procedure.~   "
54328|NCT02346006|"~     An increasingly physical inactive lifestyle in the Western World has led to a higher number~     of lifestyle -related diseases. The consequences are now already present in childhood with~     an increased prevalence of overweight, obesity, and diabetes. Inactivity is also accompanied~     by cardiovascular iseases and is also thought to be associated with an increased incidence~     of nearsightedness (myopia).~      Myopia is the most frequent eye disease globally, and causes severe personal and societal~     expenses and may additionally lead to secondary eye disorders such as retinal detachment,~     glaucoma, and cataract.~      The retina is the only place in the human body where it is possible to directly inspect the~     blood vessels (microvasculature). Photography of the eye background allows a noninvasive~     examination of the retinal structure in which it is possible to make measurements on the~     retinal blood vessels.~      It is well known that early vascular chances can be detected with this method and that there~     are correlation between these changes and systemic diseases, such as hypertension, stroke~     and other cardiovascular diseases.~      This study is a new subproject in The Childhood Health, Activity, and Motor Performance~     School (CHAMPS) Study Denmark, also known as the Svendborg Project. The project has a~     well-defined cohort with originally 1515 school students who since 2007 have been divided~     into two groups: schools with extra exercise during school hours and matched traditional~     schools. CHAMPS-DK aims to investigate the effect of increased physical activity on current~     and future health of children and adolescents.~      Thanks to this unique child cohort it is possible to investigate the correlation between~     physical activity, myopia and retinal vascular diameters in a large group of Danish~     schoolchildren. We want to study the degree and reversibility of physical activity and its~     effect on the development of myopia and retinal blood vessel changes. However, there is~     still a lack of knowledge about the correlation between physical activity and retinal~     vascular diameters in children. Furthermore, it is still unclear whether physical activity~     can prevent the development of myopia; such a realization could have far-reaching~     consequences in form of a modified approach to the necessity for exercise and, furthermore,~     potentially a significant socio-economic benefit.~   "
54329|NCT02345993|"~     The purpose of this study is to determine whether extra fine formoterol/beclomethasona are~     more effective in the treatment of asthmatic crisis when added to conventional treatment~     compared with conventional treatment alone.~   "
54330|NCT02345980|"~     Despite its beneficial effect, ureteral stents may produce lower urinary tract symptoms~     (such as dysuria, frequency, urgency, urge incontinence and suprapubic pain) that affect the~     quality of life and sexual health in 70-80%.~      This study will be conducted to evalute the role of Phosphodiestrase 5 inhibitor~     (Sildenafil) in relieving these symptoms.~   "
54331|NCT02345967|"~     The purpose of this study is to verify safety and assess tolerance of a long-term, implanted~     glucose monitoring sensor. The study will also provide data to characterize the response~     properties and calibration of the implanted sensor and determine if such properties vary~     with implant duration.~   "
54332|NCT02345954|"~     The purpose of this study is to compare the operative, anatomic functional outcome as well~     as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared~     to laparoscopic hysteropexy (conserving the uterus).~      The investigators expect that both laparoscopic procedures are equal in regards to operation~     time, complication rate, anatomic and functional outcome as well as subjective outcome.~   "
54333|NCT02345941|"~     This project will utilize the first web-based program to provide tailored injury prevention~     education. The existing Safety in Seconds program was adapted into a smartphone platform.~     Parents are recruited from and engage in the program in the clinical setting (PED or PTS).~     Parents download the app onto their smartphone which is used to ask the questions, collect a~     parent's responses, assess the parents' safety needs and give tailored directions for proper~     car sear use. The control group parents will also engage with the smartphone app and receive~     immediate feedback. However, they will receive tailored educational messages about smoke~     alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have~     educational features (e.g., tips for keeping children content in their CSSs, links to~     helpful websites). The investigators will use emerging technology such as push notification~     and email to remind parents to visit the portal and have their child's car seat reassessed.~      The investigators plan to conduct a cost benefit analysis of the program's expected~     financial benefit from the perspective of a third party payer of medical claims and an~     in-depth examination of program adoption and implementation using qualitative data collected~     from key informant interviews, direct observations of the clinic environments, and document~     review.~   "
54334|NCT02345928|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose~     administered IV in participants with asthma and atopic dermatitis.~   "
54335|NCT02345915|"~     Taking into account the specificities of adolescent and young adult cancer patients led~     agencies (in particular the French National Cancer Institute INCa, through the last Cancer~     Plan), to initiate projects targeting this population. Acute leukemia is among the most~     common cancers in adolescents and young adults. Recent therapeutic advances now allow hope~     for a cure in about 50% of this population. The issue of post-cancer is therefore of~     particular importance for young adults with cancer. Our aim is to establish the health~     determinants in young adult leukemia survivors and to compare the frequency of these effects~     and their explanatory factors to the data collected in children or adolescent leukemia~     survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer~     center and Nice University Hospital have been identified and would be included in this~     study.Collected data will include information on the initial disease and its treatments,~     physical sequelae (fertility, thyroid function, heart function, visual function, secondary~     tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic~     syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational~     integration and relationship with care system.~   "
54336|NCT02345902|"~     Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This~     study will evaluate which is the best treatment for hypoactive delirium.~   "
54337|NCT02345889|"~     Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval~     colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices~     attached to the colonoscope tip may improve the ADR of doctors performing a screening~     procedure~   "
54353|NCT02345668|"~     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol~     (Emotion Regulation Protocol) for the treatment of unipolar mood disorders (major depression~     and dysthimia) four anxiety disorders (Panic disorder, agoraphobia, generalized anxiety~     disorder and social anxiety disorder) and obsessive-compulsive disorder in comparison with~     Treatment as Usual in specialized care (Spanish public mental health system).~   "
54400|NCT02345057|"~     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate~     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2~     Diabetes Mellitus and Microalbuminuria.~      The Primary endpoint is the change from baseline in urinary albumin to creatine ratio~     (UACR).~   "
54338|NCT02345876|"~     The hypothesis of central auditory processing disorders has been advanced to explain the~     anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders~     may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and~     of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to~     handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast,~     in the subject-handed dyslexic, the efferent system tends to be right-lateralized or~     non-lateralized. However, after an audio-visual training, normal lateralization can appear.~     This maturation of the efferent system lateralization during reading acquisition seems to~     have a particular profile in dyslexics with phonological disorder, especially if it is~     persistent. This finding allows to consider new prognostic evaluation and speech therapy~     rehabilitation in the dyslexic child.~   "
54339|NCT02345863|"~     A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of~     a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib~     and GA101 maintenance in CLL patients.~   "
54340|NCT02345850|"~     The study is designed as a three arm randomized Phase III, multicenter trial comparing two~     calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis~     to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies~     undergoing myeloablative conditioning hematopoietic stem cell transplantation.~   "
54341|NCT02345837|"~     The aim of this study is to detect whether or not performing an endometrial sampling in the~     cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes~     in the next cycle.~   "
54342|NCT02345824|"~     This is a single-institution, open-label, early-phase study to assess the ability of~     ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability~     in core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or~     anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant~     preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6~     inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient~     tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or~     anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the~     investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients~     with Rb-positive tumors.~   "
54343|NCT02345798|"~     This pilot clinical trial studies a video-assisted intervention in improving recovery of~     patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and~     their caregivers. The intervention uses educational videos to prepare patients and families~     for surgery and teach them how to manage the symptoms after surgery. Teaching patients and~     their families what to expect before and after surgery may help improve patient and~     caregiver quality of life, help patients recover better from surgery, and support families~     in their role as caregivers after surgery.~   "
54344|NCT02345785|"~     The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal~     block using ultrasonography in pediatric patient.~   "
54345|NCT02345772|"~     Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel,~     Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of~     surgery in ER-positive and HER2-positive patients with breast cancer.~   "
54346|NCT02345759|"~     Dietary management of CKD patients proved important to postpone dialysis. Long-term~     compliance to protein-restricted diets was discussed. Psychological aspects involved in~     certain dietary behaviour have never been studied.~   "
54347|NCT02345746|"~     In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients~     with liver-only or liver-predominant metastases who have failed at least one line of~     systemic chemotherapy.~   "
54348|NCT02345733|"~     The goal of the study is to evaluate strategies that target the microbiota for the treatment~     of Ulcerative Colitis , This study will involve a novel diet that the investigators~     developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain~     metabolic pathways and use of pathways that increase risk of inflammation . The~     investigators have postulated that manipulation of colonic bacterial metabolism with this~     diet will induce remission in UC without involving additional immune suppression.~   "
54349|NCT02345720|"~     The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)~   "
54350|NCT02345707|"~     This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design~     in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt~     tablet formulations relative to the current CAB sodium salt formulation being used in the~     phase IIb studies under fasting conditions. All treatments will be administered as single 30~     mg doses of CAB. Safety evaluations and serial PK samples will be collected during each~     treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study~     drug. Treatment period doses will be separated by a 14 day washout. Participation in this~     study will be approximately 12 weeks.~   "
54351|NCT02345694|"~     The purpose of this randomised controlled study is to determine the impact of continuous~     positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait~     upon severe sleep apnea patients, based on stride time variability.~   "
54352|NCT02345681|"~     Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid~     balance over a very short period of time. This positive fluid balance is the consequence of~     different organ failures (pulmonary, cardio-vascular, kidney…) or aggressive fluid~     resuscitation, which is mandatory in the early phase of ICU course. However recent data~     strongly suggest that an excessive fluid balance could be detrimental per se (increase of~     ICU morbidity or even mortality). There are controversies regarding the potential benefit of~     controlling this fluid balance with diuretics which are commonly used worldwide in various~     indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature~     data are lacking, regarding the possible advantages and drawbacks of diuretics in this~     indication. The aim of our study is to test an algorithm with furosemide to reduce fluid~     overload in severe ICU-patients.~   "
54375|NCT02345382|"~     To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and~     recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule~     in subjects with advanced acute leukemia~   "
54354|NCT02345655|"~     In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment~     (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and~     methadone. Number of treated patients is around 150,000 with 75% of them treated by~     buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for~     initiating methadone, whereas it is recommended for initiating buprenorphine and during~     follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative~     analysis of the recent drug consumption, with detection based on designated thresholds,~     allow a better appraisal of drug exposure, before initiating and during OMT. While intrinsic~     diagnostic value of these tests is already demonstrated, the consequences of carrying out~     these tests on OMT have not been clearly established. Some studies suggest that patients~     exposed to drug tests may have a better OMT retention and in patients treated by methadone,~     performing urine screening tests has been shown to be associated with a mortality risk~     reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the~     recommendations to perform these tests, few GP prescribe tests, and few patients are~     regularly screened. Availability of commercial kits for urine drug testing in the medical~     office should improve their utilisation.~      The widespread of urine drug screening tests use in ambulatory care is a reality for some~     GPs working in addictology networks. Despite a global benefit reported in the literature~     with a better control in prescribing OMT and a better patients' adherence, as far as the~     investigators know, no study has yet explored the impact of the use of urine drug screening~     test in decision making in general practice with an intervention study.~   "
54355|NCT02345642|"~     We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable)~     in both the supine an standing position. We will start supine and will take 3 baseline~     measurements of venous velocity and then apply a device and take 3 measurements of the~     increase in peak venous velocity. We will repeat this with the second device. We will then~     have the subject stand and repeat the above with each device. We will randomize the order of~     the devices in the supine and standing position. This study will involve 10 healthy subjects~     of various ages and 10 THR patients.~   "
54356|NCT02345629|"~     The goal of this clinical research study is to learn if a cordotomy reduces pain in patients~     with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography~     (CT) scans, that is performed on the spinal cord and is designed to reduce pain~     transmission.~   "
54357|NCT02345616|"~     The pulmonary hypertension (HTP) due to a left heart disease or a hypoxemiant lung disease~     is frequent in cardiac surgery. The HTP represents an independent risk factor of morbidity~     and mortality in cardiac surgery, entering to the criteria of Euroscore evaluation (European~     System for Cardiac Operative Risk Evaluation).~      An acute perioperative hemodynamic decompensation of these patients is frequent.~     Perioperative hemodynamic modifications, hypoxemia, hypercapnia, sympathetic stimulation,~     increase pulmonary vascular resistances (RVP) and might provoke right ventricular failure.~      The anesthetic induction and the beginning of mechanical ventilation are the most sensible~     times due to the risk of hemodynamic decompensation. The suppression of the sympathetic~     tonus which is consequence of the anesthetic induction, decrease the systemic vascular~     resistances and lead to decrease of blood pressure. In return, the anesthetic induction is~     associated with an increase of pulmonary vascular resistances, resulting in increase of the~     postcharge and the work of the right ventricle (VD). These systemic and pulmonary~     hemodynamic modifications can lead to equalization, or even an inversion of the systemic and~     pulmonary pressures. As consequence, a hemodynamic collapse or even a heart arrest can~     arise.~      The patients suffering from HTP are hypoxemic. They have very limited oxygen reserves due to~     decrease of the functional residual capacity (CRF). The apnea period, which follows the~     anesthetic induction, is often associated with a fast desaturation, even if a good~     pre-oxygenation was performed before. This desaturation causes an increase of the pulmonary~     vascular resistances with the hemodynamic consequences previously mentioned. A risk of~     hypoxic heart arrest is also present.~      Nitric Oxide (NO) is an endogenous mediator produced from the vascular endothelium. The NO~     is a powerful vasodilator and is used in intensive care in inhaled way as selective~     pulmonary vasodilator (iNO). NO decreases the RVP, the shunt effect and improves the~     oxygenation by optimization of ventilation-perfusion ratio. The short lifetime of iNO (6sec~     approximately) allows a fast metabolism without inducing any undesirable effects such as the~     systemic hypotension.~      No studies, until now, have investigated the use of iNO in pre-oxygenation before anesthetic~     induction in cardiac surgery.~      We hope to demonstrate that iNO used in oxygenation before anesthetic induction will have a~     beneficial effect on the respiratory and cardiovascular parameters.~      Our objective is to estimate the feasibility and the tolerance of iNO before anesthetic~     induction of the patients with a moderate or severe HTP programmed for cardiac surgery with~     extracorporeal circulation. The effect will be estimated in terms of efficiency (hemodynamic~     and respiratory optimization).~   "
54358|NCT02345603|"~     Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due~     to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected~     to about 60 seconds each of freezing by application of liquid nitrogen in dedicated~     catheters around the circumference of each artery. Another 5 patients that are not subjected~     to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure~     levels.~   "
54359|NCT02345590|"~     Weakening and expansion of the main abdominal artery (abdominal aortic aneurysm, AAA) is a~     common problem in older Australians. The majority of AAAs are small (<55 mm) and affect~     90,000 individuals in Australia and 4.5 million world-wide. Currently, the only treatment~     available for AAA is surgery. However, surgical therapies are not effective for small AAAs,~     and these patients undergo a program of repeat imaging and consultation to monitor the size~     of the aneurysm and symptoms.~      This proposal is aimed at addressing the urgent need to identify a medical treatment able to~     limit progression of AAAs.~      The study design and rationale are based on strong preclinical evidence supporting the value~     of eplerenone (an agent indicated for treatment of heart failure) in limiting AAA~     progression. If proved effective, this medication would:~        1. Reduce the number of patients requiring costly surgery~        2. Reduce the number of surgery related deaths and complications~        3. Provide a therapy suitable for the rapidly expanding elderly age group who have AAAs.~   "
54360|NCT02345577|"~     Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the~     early post-transplantation period and suffer from increasing abnormalities of neuromuscular~     functions.~      Stochastic whole body vibration (WBV) therapy is a relatively new form of movement~     physiotherapy that is used for strength training. Various clinical studies have shown that~     in addition to muscle function, WBV also improved body balance and bone mineral density. To~     study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal~     transplantation, kidney transplant recipients will be enrolled and undergo WBV. The~     investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and~     muscular performance~   "
54361|NCT02345564|"~     Osteochondral lesions in knee and ankle are injuries commonly seen in young patients.~     MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.~      This prospective study follows patients treated with MaioRegen implants from pre-surgery~     until 24 months post-surgery.~   "
54592|NCT02342522|"~     The purpose of this study is to determine whether remote ischemic conditioning can reduce~     cardiac death and hospitalization for heart failure in patients presenting with a~     ST-elevation myocardial infarction and treated by percutaneous coronary intervention.~   "
54362|NCT02345551|"~     This project will assess the feasibility of a 12-week physical activity program developed~     specifically for females exposed to a known occupational carcinogen - shiftwork. Physical~     activity has been shown to decrease cancer risk, but the investigators research has found~     that female shift workers face unique barriers to participating in physical activity. This~     project will use a combination of telephone-based behavioural counseling sessions with a~     physical activity coach, and innovative web-based physical activity tracking software using~     a Fitbit and website or smartphone app to address commonly reported barriers to physical~     activity in female shift workers.~   "
54363|NCT02345538|"~     The purpose of this study is to establish the range of pelvic floor pressure in groups of~     women, including women with and without pelvic pain, and compare the change in perineometer~     measurements between rest and maximum pelvic floor contraction in women with and without~     pelvic pain. Purpose is also to determine whether resting pelvic floor perineometer~     measurements correlate with the severity of pain symptoms in women with chronic pelvic pain.~   "
54364|NCT02345525|"~     The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced~     Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT)~     delivered in a outpatient setting on upper limb motor recovery in stroke survivors.~   "
54365|NCT02345512|"~     People with learning disabilities (LDs) experience high levels of health problems, including~     cerebral palsy, other problems associated with posture, movement and function, and injury~     (falls are the commonest cause of injury in this population, and poor balance/coordination~     are a contributory factor). The aim of this project is to investigate the clinical and cost~     effectiveness of lycra splinting garments (LSGs), worn to improve posture, movement and~     function, for adults (16 years and over) with LDs who fall. This project aims to investigate~     the clinical and cost effectiveness of LSGs to prevent future falls of adults with LDs, to~     inform practice and guidelines within local and national NHS adult services.~      Falls and fall injury are a serious problem for people with LDs (people with LDs experience~     similar rates of falls as the elderly in the general population but at a younger age),~     whereby interventions are warranted. Labbased 3D movement analysis will be conducted with~     adults with LDs who fall during two visits to perform simple tasks (e.g. walking) (once~     prior to being provided with LSG, and once 6 weeks after wearing the LSGs at home).~   "
54366|NCT02345499|"~     To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in~     the elderly patients, both in terms of functional and clinical outcome measures. A more~     meaningful comparison of the two modalities is that of a randomized controlled trial.~   "
54367|NCT02345486|"~     The administration of intravenous crystalloids is ubiquitous in the care of the critically~     ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte~     compositions including a range of chloride concentrations. Recent studies of associated~     higher fluid chloride content with acute kidney injury and mortality but no large,~     randomized trials have been conducted. In preparation for a large, cluster-randomized,~     multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic~     crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot~     study will enroll all patients admitted to the medical intensive care unit at a single~     tertiary center for a sixth month period. The primary objective will be to test the ability~     of an electronic order entry tool to ensure administration of assigned study fluid or record~     contraindications to assigned study fluid. The pilot study will also demonstrate the~     feasibility of collecting demographic, severity of illness, fluid management, vital sign,~     laboratory, acute kidney injury and renal replacement therapy, and outcome data in an~     automated, electronic fashion.~   "
54368|NCT02345473|"~     Very few factors may be identified as prognostic for patients with bladder cancer undergoing~     radical cystectomy. Recently, detection of circulating tumor cells has shown to be very~     promising in anticipating both the likelyhood of distant metastases and survival in patients~     with breast cancer, melanoma, prostate cancer and other malignancies. In the present study~     we both tested the detection rate of circulating tumor cells using a PCR based methodology~     in the peripheral blood of patients undergoing radical cystectomy, and we further correlated~     our results with their clinical outcome.~   "
54369|NCT02345460|"~     This phase II trial studies how well combination chemotherapy works in treating patients~     with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as~     irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX),~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed.~   "
54370|NCT02345447|"~     The purpose of this study is to study whether a herbal-based medication is superior to~     placebo for prevention of acute otitis media in pre-school children with upper respiratory~     tract infection.~   "
54371|NCT02345434|"~     Fraud and waste is estimated to cost the American health care system nearly $200 billion~     each year, and the public Medicare and Medicaid programs about $60 billion each year. This~     study will evaluate a new method for fighting fraud: mailing informative letters to outlier~     providers to notify them of their aberrant behavior. These letters are targeted at high~     prescribers of schedule II controlled substances in Medicare Part D. The investigators will~     look at the effects of these letters on the behavior of providers and their patients. These~     effects are of substantial policy interest as they suggest how to best design anti-fraud~     policies. They are also of academic interest, shedding light on the behavior of physicians~     and their patients.~   "
54372|NCT02345421|"~     The objective of this study is to determine the frequency of Lysosomal Acid Lipase~     Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are~     considered to be at risk.~   "
54373|NCT02345408|"~     This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in~     patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.~   "
54374|NCT02345395|"~     The study is designed to evaluate the efficacy and safety of minimally invasive~     neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior~     circulation in the Hospital das Clínicas of the University of São Paulo Medical School.~   "
86990|NCT01918761|"~     To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated~     as determined by the incidence of DLTs (dose limiting toxicities).~   "
54376|NCT02345369|"~     The purpose of this study is to look at the effect of locking or not locking a set screw~     when placing a rod and screws device in the thigh bone and hip to fix hip fractures. The set~     screw is an extra screw in the device that will not allow the screw that goes into the ball~     of the ball and socket joint in the hip to slide at all in relation to the rod in the thigh~     bone, which it goes through. It is not known whether it is better to lock the set screw (not~     allow sliding of the hip screw) or leave it unlocked (allow sliding of the hip screw).~     Participants in this study are patients with intertrochanteric hip fractures receiving~     standard care for this injury (lining the fracture up in a normal position and inserting a~     rod in the thigh bone with a screw that goes through the rod into the ball of the ball and~     socket of the hip). Patients who consent to participate will be randomized to one of two~     arms : 1. Set screw is unlocked or 2. Set screw is locked. Participants will all get~     standard postoperative care and standard postoperative xrays.~   "
54377|NCT02345356|"~     Caribbean Hispanics are a population with a disproportionately high prevalence of~     cardio-metabolic disorders but with a limited expectation of benefits from current~     pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The~     investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription~     guidelines for this population, who have arisen from European, West African and Amerindian~     genomic origins to produce a highly heterogeneous population. Our project combines admixture~     analysis and DNA-sequencing with development of more accurate rules for better~     predictability of warfarin dosing to immediately serve this medically underserved~     population.~   "
54378|NCT02345343|"~     The primary objective of the study is to report adverse events of on-treatment AEs by the~     treating physicians during a specified 24-month study period in patients with venous~     thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV)~     in Mexico.~   "
54379|NCT02345330|"~     This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12~     DNA injection (pIL-12) with electroporation (EP) in treatment-refractory metastatic and~     unresectable squamous cell carcinoma of the head and neck (HNSCC). Intratumoral pIL-12 EP is~     a gene therapy approach to directly induce a pro-inflammatory response within a tumor to~     initiate and/or enhance anti-tumor immunity.~   "
54380|NCT02345317|"~     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in~     industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional~     phenotypic characteristic frequently observed in patients with AMD. Several studies have~     proven that the prevalence of RPD is associated with AMD as well as a high risk of disease~     progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet~     still incompletely understood. Retrospective studies have demonstrated that the RPD affected~     retinal area increases over time. Potential factors influencing progression of RPD have not~     been intensely studied and potentially predictive markers are yet unknown. The primary~     objective of this study is to characterize RPD progression in more detail and to identify~     predictive markers of RPD progression and development of AMD late stages.~   "
54381|NCT02345304|"~     To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of~     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)~     and digoxin (P-gp probe drug)~   "
54382|NCT02345291|"~     A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled,~     parallel-group, dose-finding study designed to evaluate the efficacy, safety and~     tolerability of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with~     neuropathic pain. Potential study patients will sign informed consent prior to undergoing~     any study-related procedure.~   "
54383|NCT02345278|"~     Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an~     immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy~     and specific immunotherapy (IT). IT represents the only treatment that might alter the~     natural course of the disease. The amount of administered allergen is crucial for both~     efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for~     sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as~     allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM)~     allergens.~      According to the European Medicines Agency Guideline on the clinical development of products~     for specific IT for the treatment of allergic diseases, products should be tested at~     different dosages to provide preliminary data on safety and tolerability with regard to the~     maximum tolerated dose and suitable dose escalation scheme. This trial is designed to~     investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.~   "
54384|NCT02345265|"~     This phase II trial studies how well olaparib and cediranib maleate work in treating~     patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back~     (recurrent). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
54385|NCT02345252|"~     This study will evaluate the safety and efficacy of emtricitabine/rilpivirine/tenofovir~     alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) versus continuing~     emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) FDC in HIV-1 infected~     adults who are virologically suppressed on a stable regimen of FTC/RPV/TDF for ≥ 6~     consecutive months prior to screening.~   "
54386|NCT02345239|"~     The purpose of this study is to demonstrate the immediate impact of pantoprazole on 24-H~     glycemic control and on post-prandial glucose excursion in patients with type 2 diabetes.If~     our data support the previous animal, observational and clinical studies results, PPIs could~     become a new anti-diabetic agent with a good and safe profile for type 2 diabetes~   "
54387|NCT02345226|"~     This study will evaluate the efficacy and safety of emtricitabine/rilpivirine/tenofovir~     alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) versus continuing~     efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in HIV-1 infected~     adults who have been virologically suppressed (HIV 1 RNA < 50 copies/mL) on a stable regimen~     of EFV/FTC/TDF FDC for ≥ 6 consecutive months at screening.~   "
54388|NCT02345213|"~     The purpose of this study is to confirm the efficacy of Aricept in patients with dementia~     with Lewy bodies (DLB).~   "
54401|NCT02345044|"~     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate~     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese~     hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and~     diastolic blood pressure.~   "
54389|NCT02345200|"~     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by~     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer~     susceptibility. In addition to that, a high percentage of patients show dystrophy, growth~     retardation and poor weight gain. Nevertheless, there are only a few studies assessing this~     problem. Aim of the present proposal is to investigate the exact body composition, manual~     muscle strength and hormonal status in patients with A-T compared to healthy controls~     matched for gender and age. A pelvic sonography in females was performed in order to~     evaluate the sexual maturity of their inner genitalia. Tanner score was determined to define~     the physical development. Every subject received a nutritional diary to review its calorie~     intake and the quality of diet. The investigators expect that the A-T cohort shows an~     altered body composition, impaired muscle strength, changed hormonal status concerning the~     sexual hormones and a delayed physical development compared to healthy controls.~   "
54390|NCT02345187|"~     The study will aim to compare the effects of a beverage powder fortified with multiple~     micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric~     beverage powder (control product) on cognitive outcomes of attention and working memory.~   "
54391|NCT02345174|"~     Human epidermal growth factor receptor 3 (HER3) expression is seen across a wide variety of~     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression~     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330,~     a monoclonal antibody (mAb) targeting HER3, is a new agent for subjects whose tumors express~     HER3. This study aims to characterise the biodistribution and dose-receptor occupancy~     relationship of GSK2849330 in patients with advanced HER3 expressing solid tumours via the~     use of PET imaging. This study will be conducted in two parts. Part 1 will be the imaging~     phase where each subject will receive two doses of GSK2849330 containing both Zirconium-89~     (89Zr) labelled GSK2849330 and unlabeled GSK2849330. The amount of unlabeled GSK2849330~     present in each dose will be varied to explore the effect on target mediated uptake of 89Zr~     into HER3 expressing tissues and tumors. Subjects will then proceed to the continuation~     phase (Part 2) for continued treatment with unlabelled GSK2849330. The study is planned to~     enroll approximately 12-15 subjects.~   "
54392|NCT02345161|"~     This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter~     study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation~     powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of~     this study is to demonstrate improvements in lung function and health status for subjects~     treated with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily~     'closed' triple therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor~     Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5~     mcg/25 mcg) in a single device is being developed with the aim of providing a new treatment~     option for the management of advanced (GOLD Group D) COPD which will reduce the exacerbation~     frequency, allow for a reduced burden of polypharmacy, convenience, and increase the~     potential for improvement in lung function, Health Related Quality of Life (HRQoL) and~     symptom control over established dual/monotherapies.~      Subjects meeting all inclusion/exclusion criteria and who have successfully completed all~     protocol procedures at the Screening Visit will enter the two-week run-in period. Following~     the run-in period, eligible subjects will be randomised (1:1) to one of the following~     double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry~     powder inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily~     OR Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via~     the ELLIPTA DPI once daily in the morning.~      The target enrollment is 1800 randomised subjects at approximately 200 study centers~     globally. The total duration of subject participation will be approximately 27 weeks,~     consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up~     period. Subjects will run-in on their existing COPD medications for 2 weeks and in addition~     will be provided with short acting albuterol/salbutamol to be used on an as-needed basis~     (rescue medication) throughout the study. Subjects will discontinue all existing COPD~     medications during the randomised treatment period but may continue their study supplied~     rescue albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded~     study treatment for up to a total of 52 weeks to provide additional long term safety data.~      ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other~     company or product names mentioned herein may be the property of their respective owners~   "
54393|NCT02345148|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in elderly participants (greater than equal to [>=] 75~     years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).~   "
54394|NCT02345135|"~     Death in Ataxia telangiectasia (A-T) is usually due to cancer or chronic lung failure around~     20 years of age. Despite low lymphocyte counts (CD3, CD4, CD8 and CD19), IgA and IgG~     subclass deficiency opportunistic and acute severe respiratory infections are rare. The~     prevailing wisdom is that an immunoglobulin replacement therapy is not necessary in most of~     the patients. However no placebo controlled trials have been performed so far. The aim of~     this trial was to investigate the prevalence of mild and severe respiratory infections and /~     or chronic cough in classical A-T patients compared to healthy controls.~   "
54395|NCT02345122|"~     This four-year research study will evaluate an integrated care model of telephone-based,~     computer-aided care management using a new role of Mental Health Technician and specialized~     software to support primary care providers in providing mental health care. The study will~     compare the effectiveness of this model vs. enhanced usual care in improving initiation of~     specific treatment by the primary care provider, reduction in severity of symptoms, and~     improvement in quality of life or functioning.~   "
54396|NCT02345109|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2~          Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1~          Plus.~        4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.~        5. Study endpoints: DUT and the comparison device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~   "
54397|NCT02345096|"~     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on~     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is~     a randomized, double-blind, placebo-controlled study.~   "
54398|NCT02345083|"~     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous~     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in~     Indonesian elderly.~      This study was aimed to define the risk factors and clinical outcomes of frailty~     transitional status in Indonesian elderly.~   "
54402|NCT02345031|"~     This study aims to demonstrate that the investigational drug AUT00063 is effective and safe~     in the treatment of age-related hearing loss.~   "
63098|NCT02231372|"~     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for~     inhalation in patients with chronic obstructive airways disease in daily practice~   "
54404|NCT02345005|"~     This post market registry consists of a retrospective and a prospective part. The first part~     is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE~     mark was obtained, to get an initial insight on the feasibility and safety of this~     procedure. The second part is to prospectively register all data on implanted IBE Gore~     devices, in order to gain more robust data on the efficacy of the device in maintaining~     hypogastric artery patency.~   "
54405|NCT02344992|"~     The addition of BioChaperone to already marketed prandial insulin analogue accelerates the~     onset and shorten the duration of action of insulin lispro due to facilitation of the~     absorption of the insulin after subcutaneous injection.~      This trial is intented to compare the post-prandial blood glucose control of BioChaperone~     insulin lispro and Humalog® when injected after a standardized meal as well as the~     pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1~     diabetes mellitus.~      This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to~     compare the blood glucose control after ingestion of a standardized meal, with BioChaperone~     Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.~   "
54406|NCT02344979|"~     Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for~     chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and~     cisplatin or carboplatin chemotherapy.~   "
54407|NCT02344966|"~     The objective of this study is to evaluate the prognostic factors of acute leukemia patients~     and to invent the molecular genetic test for sensitive detection of minimal residual~     disease, and thereby this study would contribute to plan the risk adapted treatment.~     Patients will have samples of blood and/or bone marrow collected during diagnosis process,~     treatment and/or thereafter~   "
54408|NCT02344953|"~     The objective of this study is to evaluate the prognostic factors of acute leukemia patients~     received stem cell transplantation and to invent the molecular genetic test for sensitive~     detection of minimal residual disease, and thereby this study would contribute to plan the~     risk adapted treatment. Patients will have samples of blood and/or bone marrow collected~     during treatment or thereafter~   "
54409|NCT02344940|"~     To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with~     operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic~     abnormality,estrogen level and perimenopausal symptoms.~   "
54410|NCT02344927|"~     It is unclear whether the use of fluids given by a drip is beneficial to cancer patients~     in the last days of life, and as a result many individuals do not receive such treatment~     (although they do receive fluids by mouth, and regular mouth care). The researchers want to~     undertake a large study (main study) to determine the benefits of fluids given by a drip,~     but first need to undertake a small study (feasibility study) to ensure that the main~     study can be done.~      The feasibility study will be done in twelve units (hospitals, hospices) in England & Wales;~     each unit will be allocated a treatment at random, and all patients in the unit will receive~     that treatment (if appropriate). Standard treatment A consists of drinking fluids (if~     possible), regular mouth care, and treatment of any symptoms; standard treatment B consists~     of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of~     any symptoms.~      Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be~     recorded. The main symptom of interest is agitation (delirium), which has multiple causes,~     including dehydration and kidney failure. Uncontrolled symptoms will be appropriately~     treated, e.g. patients with pain will be given painkillers. Equally, problems relating to~     the fluids given by a drip will also be recorded. Involvement in the study will not~     interfere with the patient's general care, and there will be no additional blood or other~     tests.~   "
54411|NCT02344914|"~     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage~     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate~     pain.~   "
54412|NCT02344901|"~     The aim of this study is to evaluate the present status of stroke prevention strategies in~     patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have~     been the only available oral anticoagulant therapy for decades. Recently novel oral~     anticoagulants have emerged as an alternative for VKAs. This study is planned to evaluate~     the epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention~     strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in~     therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3)~     for warfarin patients. This is a national multicenter observational study in which Turkey is~     divided into seven regions. A proportional number of patients to the population of every~     region is planned to be included.~   "
54413|NCT02344888|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile~     lean women having CC resistant polycystic ovarian syndrome (PCOS).~   "
54414|NCT02344875|"~     The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics~     after single oral administration of FYU-981 to male and female elder subjects in comparison~     with non-elder subjects.~   "
54415|NCT02344862|"~     The purpose of this study is exploratory investigation of safety and efficacy (dose response~     and optimal dose according to the percent reduction from baseline in serum urate level at~     the final visit) of FYU-981 administered orally to hyperuricemic patients with and without~     gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4~     weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind,~     parallel group comparison.~   "
54416|NCT02344849|"~     This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal~     Stem Cells (MSC) injected intracavernously.~   "
54417|NCT02344836|"~     Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.)~     and provide social support which has the potential to play a powerful role in health~     promotion. The objective of this study is to refine and pilot test the Social POD app for~     personalized health monitoring and interaction founded on a combination of social networks,~     recommender systems, motivational research, and health behavior theory. The aim of our~     proposed project is to conduct a 3-month pilot RCT among overweight and obese adults (N=150)~     comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available~     calorie and weight tracking app (current most popular diet self-monitoring method) versus~     TBP plus self-monitoring and social support/incentive points for participating with the~     Social POD app (TBP+Social POD).~   "
54419|NCT02344810|"~     This partially randomized phase I/II trial studies the side effects and best dose of c-Met~     inhibitor AMG 337 when given together with oxaliplatin, leucovorin calcium, and fluorouracil~     and to see how well they work in treating patients with stomach or esophageal cancer that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment. C-Met inhibitor AMG 337 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as, oxaliplatin,~     leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving c-Met inhibitor AMG 337 with oxaliplatin, leucovorin calcium, and~     fluorouracil may kill more tumor cells.~   "
54420|NCT02344797|"~     Worldwide, more than 200 million patients have major non-cardiac surgery annually and a~     significant proportion of these patients suffer major cardiovascular complications (e.g.~     nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their~     surgery. Perioperative myocardial infarction is the most common cardiovascular complication~     and recent clinical studies have shown that even minor myocardial injury in relation to~     non-cardiac surgery is associated with 30-day mortality.~      Remote ischemic preconditioning is a procedure, which protects remote tissues and organs~     e.g. against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion~     by the inflation of a blood-pressure cuff for brief periods are the preferred method.The aim~     of this interventional clinical study is to determine whether remote ischemic~     preconditioning can reduce markers of myocardial injury in emergent or urgent non-cardiac~     surgery.~   "
54421|NCT02344784|"~     The purpose of this study is to show that Prepulse inhibition test of acoustic startle~     response is an indicator of objective diagnostic characteristics of attention deficit~     disorder in children and adolescents.~      by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in~     children and adolescents suffering from attention deficit disorder in the relation to the~     normal function described in the literature.~      The investigators will try to prove our hypothesis by an experiment that consists of two~     phases:~      Phase I (about 25 minutes):~      The patient will enter the room, will be asked to sit on a chair, and will be asked to look~     at a computer screen showing silent video of aquarium fish, then the patient will be~     connected to both the Prepulse inhibition test device and the Galvanic skin response device~     and pass the tests.~      Phase II (about 25 minutes):~      After completion of Phase I, each participant will receive his daily regular dose of~     methylphenidate and after an hour and a half from taking the drug, will repeat the tests,~     both the Prepulse inhibition test and the Galvanic skin response test.~      Duration of the entire experiment is 140 minutes (two hours and twenty minutes).~   "
54422|NCT02344771|"~     More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die~     within 30 days post-operatively, and of these patients 45% will die from vascular causes~     such as myocardial infarction. The pathogenesis of perioperative myocardial infarction is~     complex and to date not fully elucidated. The physiological stress response associated with~     the surgical procedure is believed to be central in the development of perioperative~     cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability~     and increases the production of catecholamines and cortisol. These drastic systemic changes~     lead to a state of myocardial oxygen supply-demand mismatch, which added to acute~     endothelial dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.~      The endothelium is a regulator of vascular homeostasis, vascular tone and structure and~     exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is~     characterized by a decreased vascular bioavailability of nitric oxide probably due to an~     increased degradation of nitric oxide via its interaction with locally produced reactive~     oxygen species. No clinical studies have investigated whether peri- and postoperative~     endothelial dysfunction is associated with an increased risk of perioperative myocardial~     injury. Endothelial dysfunction may be a key element in the development of perioperative~     myocardial injury.~      The aim of this observational clinical study is to closely examine the endothelial function~     and its dynamics in the early postoperative period.~   "
54423|NCT02344758|"~     The purpose of this study is to develope a novel method to determine gluten intake and to~     check gluten-free diet adherence in celiac patients by detection of gluten immunogenic~     peptides in urine.~   "
54424|NCT02344745|"~     Urodynamics are performed in the evaluation of urinary incontinence in women considering~     surgery or who have failed conservative therapies. Urodynamic testing requires the placement~     of small catheters into the bladder and the vagina or rectum. Many women experience anxiety~     around the procedure which can affect patient satisfaction. Lavender aromatherapy has been~     associated with decreased anxiety in a variety of clinical situations. The purpose of this~     study is to determine a difference in self-reported anxiety and pain levels before, during,~     and after multichannel urodynamics in patients given lavender aromatherapy versus placebo.~     This study design is a randomized control trial. Women scheduled for urodynamic testing at~     the Los Angeles County University of Southern California (LAC+USC) Urogynecology clinic will~     be invited to participate. Participants will be randomized to the aromatherapy or the~     placebo group after informed consent is obtained and immediately before undergoing~     multichannel urodynamics. The participants will complete the Hospital Anxiety and Depression~     Survey (HADS) at baseline. They will be asked to rate their level of anxiety and pain~     before, during, and 15 min after the study using the visual analogue scale and Wong-Baker~     pain scale. At the end the participants will also be asked to rate their satisfaction with~     the visit overall. The primary endpoint is defined as anxiety immediately after catheters~     are placed. Data will be entered into a coded database for analysis using the independent~     samples t test, the Mann-Whitney U test, and the chi square test. Intention to treat~     analysis will be used.~   "
54425|NCT02344732|"~     1. To compare the corneal epithelial defect healing time between diabetic patients~          receiving and not receiving supplementary oxygen after vitrectomy.~        2. To determine whether factors such as age, duration of diabetes, duration of surgery and~          level of glycemic control have any influence on corneal epithelial wound healing time~          in diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.~   "
54426|NCT02344719|"~     The investigators want to analyze the effect of Taurin on portal hemodynamics in patients~     with advanced liver cirrhosis.~   "
54427|NCT02344706|"~     A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain~     unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to~     diagnose, and impossible without the required instruments. Electroencephalogram is required~     in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and~     implementation of such a device in the prehospital field is little studied. The aim of this~     study is to evaluate the diagnostic value of the acquired electroencephalogram with a~     prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor.~     The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three~     channels are monitored, as this is deemed sufficient for the prehospital field, as well as~     for monitoring the epileptic seizures.~   "
54428|NCT02344693|"~     Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect~     the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes~     following a successful cardiopulmonary resuscitation is usually deemed imperative, if the~     patient is to survive. Monitors for evaluating the cardiac function during and after~     resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure~     monitoring, cardiac sonography), but no devices for registration of the cortical brain~     activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a~     prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator,~     in patients who regain spontaneous circulation following non-traumatic cardiac arrest.~   "
54429|NCT02344680|"~     In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV~     co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of~     antiretroviral drugs in the prevention and/or reduction of liver disease.~   "
54430|NCT02344667|"~     Recent studies support the use of Stereotactic Body Radiation Therapy (SBRT) for the~     treatment of localized prostate cancer (PrCa). SBRT is a way to deliver radiation very~     precisely allowing higher doses to be delivered with fewer treatments, potentially improving~     patient outcomes. Cyberknife and Volume Modulated Arc Therapy (VMAT) are accepted SBRT~     techniques. However, the effects of the specific SBRT treatment technique on patient~     outcomes have not been evaluated in randomized trials.~      Although such a trial would be of great interest, patients' willingness to participate is~     unclear. Multiple patient and clinician factors contribute to the decision to enter a~     randomized trial. This feasibility study will evaluate patients' willingness to participate~     in a trial comparing Cyberknife and VMAT SBRT for the treatment of early stage PrCa.~     Patients accepting enrolment will be randomized to one of the two types of SBRT delivery. Up~     to 66 patients will be approached, and up to 40 randomized. A questionnaire will help to~     identify the factors influencing the patient's decision to participate or not. This study~     will gather information on feasibility, PSA control, patient outcomes and side effects, and~     will inform the design of a future randomized phase II/III study.~   "
54431|NCT02344654|"~     The primary objective is to compare the success rates of intraoperative fluorescent~     cholangiography using indocyanine green versus conventional X-ray cholangiography for the~     identification of bile duct anatomy during laparoscopic cholecystectomy for complicated~     gallstone disease in a randomized design with 120 patients.~   "
54432|NCT02344641|"~     The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart~     failure patients with exenatide, and also investigates the mechanisms of exenatide improving~     heart function.~   "
54433|NCT02344628|"~     The study will be a single blinded, randomized, controlled open label non-inferiority phase~     III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The~     ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg~     dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws~     patients will be included in the study. Patients will be randomized to receive treatment~     with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20~     mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The~     follow-up period of patients will be 6 months. Assessments before, during and after the~     antibiotic treatment will include full medical history, clinical assessment of the lesion~     and, laboratory investigations. The primary efficacy parameters are healing of the lesion at~     4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.~   "
54434|NCT02344615|"~     The investigators compared the postoperative analgesia of nerve stimulator-guided and~     ultrasound-guided infraclavicular block for upper extremity surgery.~   "
54435|NCT02344602|"~     Patients with type 1 diabetes mellitus (T1DM) are at high risk of developing kidney~     complications potentially leading to end stage renal disease. Uric acid (UA), the end~     product of purine metabolism, emerged as an important determinant of renal and vascular~     injury due to its ability activate the renin-angiotensin-aldosterone system (RAAS) and~     increase production of harmful reactive oxygen species (ROS). ROS cause progressive~     endothelial cell dysfunction, inflammation, tissue fibrosis and eventually cell death. These~     processes are enhanced in DM because of the effect of hyperglycemia.~      Since existing preventive drug therapies fail to completely prevent kidney damage, an~     examination of the effect of UA lowering against initiation and progression of renal and~     vascular complications is therefore of the utmost importance. The purpose of this study is~     to examine the effect of UA lowering with febuxostat on renal and systemic vascular function~     in patients with uncomplicated T1DM. It was hypothesized that UA lowering will improve~     kidney and systemic vascular function through effects on blood vessel function and~     anti-inflammatory effect.~      Kidney and blood vessel function will be assessed under conditions of normal and high blood~     sugar levels before and after 8 weeks of treatment with the UA lowering drug febuxostat in~     patients with diabetes and during normoglycemia only in health controls.~      Current treatment for renal and vascular complications in DM patients includes blockade of~     the RAAS. Unfortunately, angiotensin converting enzyme inhibitors (ACEi) and angiotensin II~     (AngII) receptor blockers (ARBs) lead to incomplete RAAS suppression, and do not completely~     prevent renal or vascular complications. Moreover, dual RAAS blockade increases renal and~     cardiovascular risk. Recent experimental work suggests that UA lowering therapies can block~     the RAAS, suppress inflammation and promote renal and systemic vascular protection.~     Therefore, our study is critical in determining the possible role of early UA lowering on~     renal and systemic hemodynamic dysfunction in young patients with T1DM.~   "
54436|NCT02344589|"~     Our aim is to investigate which components of the quadriceps femoris muscle are affected~     following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by~     electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml~     lignocaine 1%) as an active comparative will be used for model control. Further, we want to~     investigate the effect of volume on motor block. This will be evaluated by measuring the~     Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.~   "
54627|NCT02342067|"~     A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of~     Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK~     of PGZ administered with and without CVC.~   "
54437|NCT02344576|"~     The left ventricular assist device (LVAD) is growing rapidly among people dying from~     end-stage heart failure who are unable to get a heart transplant. These patients elect to~     live out the remainder of their lives dependent on a partial artificial heart—so-called~     destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many~     risks, including stroke, serious infection, and bleeding. Most of these patients have other~     medical problems that are not fixed by the DT LVAD. Patients must be connected to~     electricity at all times. A caregiver is required, which often places stress on loved ones.~     Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one.~     Unfortunately, our research shows problems with the way this medical decision is currently~     being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do~     not follow a standard process. The forms, pamphlets, websites, and videos used to help~     patients and families are biased and too difficult for most people to understand. Lastly,~     this is an emotional and even scary decision for most patients and their families, but the~     process does not help them deal with these feelings.~      Using feedback from patients, caregivers, clinicians, the study team made a paper and video~     decision aid to help people who are offered DT LVAD make this most difficult of decisions.~     Unlike the information that is now available, our decision aid focuses on options, fears,~     and the needs of caregivers, is balanced, and is paired with training for doctors and nurses~     on how to best talk about DT LVAD. The investigators now propose to test the effectiveness~     and implementation of this intervention. The investigators will apply the Reach,~     Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a~     stepped-wedge, cluster-randomized, controlled trial across 6 medical centers.~      Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support~     intervention to improve patient and caregiver experiences.~      Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b:~     Post-implementation, patients and caregivers will have improved decision quality (greater~     knowledge and higher value-treatment concordance).~      Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision~     support intervention across multiple providers and settings.~      Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently;~     and maintained after trial completion.~   "
54438|NCT02344563|"~     A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two~     formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion~     in healthy volunteers.~   "
54439|NCT02344550|"~     The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole~     with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen~     treatment.~   "
54440|NCT02344537|"~     The investigators wish to conduct a preliminary study to examine the efficacy of meditation~     among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators~     will use the breathing, meditation, and stretching techniques common to Kundalini Yoga~     practice. The investigators plan to assess the degree in which this practice can reduce~     Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients~     with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes~     will include cognitive complaints, physical and mental functioning, medical utilization,~     somatic symptoms, and psychopathology.~   "
54441|NCT02344524|"~     The purpose of this trial is to study the role of small bore chest drains in draining~     traumatic hemothorax and pneumothorax.~   "
54442|NCT02344511|"~     Dalbavancin for Pediatric Osteomyelitis~   "
54443|NCT02344498|"~     Viral hepatitis kills nearly one million people each year, even though effective treatment~     exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is~     simple and cheap enough to be implemented in resource-limited settings.~   "
54444|NCT02344485|"~     The aim of this pilot study is to investigate the effect of Osteopathic Manipulative~     Medicine (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD).~     A second but optional aim is to determine if OMM changes the bacterial flora of the mouth~     and gut. OMM is a safe and gentle manual treatment provided by osteopathic physicians. All~     participants will receive OMM during the second half of the eleven week trial.~   "
54445|NCT02344472|"~     A multicenter, randomized phase III study to compare chemo- versus endocrine therapy in~     combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta®~     (pertuzumab) in patients with HER2 positive and hormone-receptor positive metastatic breast~     cancer.~   "
54446|NCT02344459|"~     The purpose of this study is to perform a randomized controlled trial to compare the~     efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for~     pre-induction cervical ripening by evaluating the change in Bishop score.~   "
54447|NCT02344446|"~     The purpose of this study is to investigate if skilled physical therapy treatment for~     dizziness after sports-related concussion, delivered after greater than 30 days~     post-concussion is effective to remediate physical symptoms. This will be the first study~     that explores differential PT treatment for dizziness in concussed athletes who have~     physical symptoms 30+ days after concussion. The findings of this important research have~     great potential to influence clinical practice and place increased emphasis on and~     acceptance of manual skills and neuromotor training in the treatment of concussed patients~     with dizziness.~   "
54448|NCT02344433|"~     A Relational Agent (RA) virtual counselor (VICKY: VIrtual Counselor for Knowing Your~     Family History) has been developed to collect family health history information for common~     health conditions including heart disease, stroke, diabetes, hypertension and various~     cancers. In this study, the investigators will conduct a randomized controlled trial (RCT)~     to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool~     for collecting family health history information among an underserved primary care patient~     population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus~     MFHP for collecting accurate family health histories and 2) determine whether accuracy~     varies as a function of health literacy. This project will obtain validation data on the~     efficacy of both VICKY and MFHP for collecting accurate family history data among an~     underserved patient population, in two languages (English and Spanish). The study will~     determine whether a virtual counselor can overcome many of the existing barriers to using~     traditional web-based family history tools.~   "
54449|NCT02344420|"~     BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response~     rate in a Heart Failure (HF) population with an equal distribution of men and women.~     Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF~     etiology…) and compared in order to demonstrate that women may respond even better than men.~   "
54470|NCT02344134|"~     The purpose of this study is to describe the immunogenicity and safety of the cell~     culture-derived influenza vaccine compared with the egg-derived influenza vaccine among~     subjects.~      To describe the immunogenicity, antibody levels are evaluated by hemagglutination~     inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.~      To describe the safety, the time of onset and duration of local and systemic solicited~     adverse events are assessed and reported. Unsolicited adverse events and serious adverse~     events are collected and categorized throughout the study period.~   "
54450|NCT02344407|"~     Background:~      - Ebola virus disease (EVD) affects many people in Liberia and other countries in West~     Africa. It is caused by the Ebola virus and makes people sick with fever, headache,~     vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no~     approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not~     cause Ebola.~      Objectives:~      - To study the safety and efficacy of two Ebola vaccines.~      Eligibility:~      - Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never~     had Ebola.~      Design:~        -  Participants will give information including birthdate, gender, occupation, and~          location of home. They will give contact information for themselves and 2 alternate~          contacts. They will give a history of their contact with people with Ebola. Some~          participants may have a physical. They may have blood taken.~        -  Participants will be injected with either an Ebola vaccine or a placebo with a needle~          in the upper arm. The placebo is a salt solution.~        -  Participants will have blood taken.~        -  Participants will be watched for 30 minutes.~        -  Participants will return to the clinic 1 week and 1 month after they get the shot. They~          will have blood taken.~        -  After that, participants will be contacted monthly to discuss how they are feeling.~          They may be contacted by phone, may visit the clinic, or may have a home visit.~        -  The study ends 8-12 months after participants get the shot. If one of the vaccines~          works against Ebola and does not have many side effects, participants can get the~          vaccine if they did not get it in the study.~   "
54451|NCT02344394|"~     The overall objective of the study is to compare and assess the clinical outcomes of the~     standard of care hybrid ablation using epicardial ablation in conjunction with endocardial~     PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with~     additional RF ablation in a randomized, prospective population of patients with persistent~     AF of at least 6 months duration. All devices that are used are being utilized under the~     approved labeling of the devices.~   "
54452|NCT02344381|"~     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and~     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles~     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)~     levels. Both liver and muscle glycogen are important for our ability to perform~     intense/prolonged endurance exercise. Therefore, it is important to replete these stores~     after an intense/prolonged endurance exercise session in order to recover and perform~     optimally during a subsequent exercise bout, especially if the next exercise session is~     within 24h (e.g. stage races such as the Tour de France, tournament-style competitions such~     as the Olympic games and ultra-endurance events).~      Carbohydrate intake has been shown to increase the availability of glycogen in the muscle~     and liver after exercise. The carbohydrates typically found in sports drinks are glucose and~     sometimes fructose. It has been observed that the ingestion of glucose will lead to a~     maximum rate of absorption of approximately ~1 g/min. However, if we also provide a~     different source of carbohydrate (fructose) then this is absorbed through a different~     pathway and therefore we can absorb up to ~1.75 g/min of carbohydrate. In addition, both~     carbohydrate sources are metabolised differently in the human body. By supplementing both~     glucose and fructose, we can potentially replenish the liver and muscle glycogen stores at a~     faster rate than ingestion of glucose only.~      Sucrose is a naturally occurring sugar that is made up of a single glucose and single~     fructose molecule. Therefore, theoretically, this can use the two different pathways of~     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact~     this has on our liver and muscle glycogen stores post-exercise when supplemented in~     relatively high amounts. Therefore the aim of this study is to assess whether relative high~     amounts of sucrose ingestion will improve liver and muscle glycogen repletion after~     endurance exercise.~   "
54453|NCT02344368|"~     Despite the fact that oral sucrose is the most frequently studied non-pharmacological~     intervention for procedural pain relief in infants, there is a paucity of data on the~     minimal effective dose. The aim of this study is to find the minimal effective dose of~     sucrose to reduce pain during a single venous blood sampling procedure.~   "
54454|NCT02344355|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care~     treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will~     receive high-dose ascorbate in addition to the standard treatment.~   "
54455|NCT02344342|"~     The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a~     home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure~     patients in the University of Michigan Health System (UMHS).~   "
54456|NCT02344329|"~     A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care~     and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized~     care and, if unsuccessful, use advanced modalities. This prospective clinical trial will~     compare healing rates between two treatment modalities in patients with DFUs in an~     ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with~     AmnioExcel® and TCC-EZ with standard treatment.~      Adult participants 18 years or older with a diabetic foot ulcer located on the plantar~     surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family~     Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in~     reduction in wound area after two weeks of standard treatment. For those potential subjects~     who do not have 3rd party reimbursement the cost of the product and application will be~     covered by the respective company. They must be cognitively intact as evaluated by wound~     clinic primary care providers. Participants must agree to use the study treatments as~     directed, and to keep clinic visits during the 12-week trial or until the ulcer closes,~     whichever comes first.~   "
54457|NCT02344316|"~     Migraine in adolescents is common and effective and safe preventive treatments are needed.~     This is a pilot randomized controlled trial of melatonin versus placebo for migraine~     prevention in adolescents 12-17 years old.~   "
54458|NCT02344303|"~     Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and~     supratherapeutic doses.~   "
54459|NCT02344290|"~     The study is funded by the National Heart, Lung, and Blood Institute, with additional~     infrastructure support provided by the National Institute of Allergy and Infectious~     Diseases.~      People infected with HIV are at risk for cardiovascular disease (CVD). This study will~     evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who~     are on antiretroviral therapy (ART).~   "
54471|NCT02344121|"~     Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor~     target volumes and surrounding normal organs in radiation therapy.~   "
54485|NCT02343965|"~     Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more~     than 6,000 of these requiring hospitalization in a protective, sterile environment. New~     methods, such as touch massage, have emerged in response to anxiety symptoms observed in~     patients in such sterile and isolated surroundings. We hypothesize that during the period of~     isolation, touch massage becomes a nursing care which can help the patient.~   "
87097|NCT01917370|"~     The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism~     in HCC growth, proliferation and apoptosis.~   "
54460|NCT02344277|"~     Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and~     sudden death resulting from episodes of polymorphic ventricular tachychardia and~     fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only~     treatment available is the implantation of an ICD. There is no discussion on the interest of~     the ICD implantation in secondary prevention and in patients who experienced syncope but the~     best therapeutic is more difficult to draw in asymptomatic patients. Recently we~     demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada~     syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of~     inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead~     failure remains the main problem in this young population very active and represent the main~     limitation to larger indication of ICD implantation in this population with a very long life~     expectancy as these patients had a normal life expectancy except the risk of ventricular~     arrhythmia.~      In this context the S-ICD System (Boston Scientific Inc.) which is an implantable~     defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse~     generator and electrode system rather than a transvenous lead system, represents a very~     attractive opportunity as it gives the possibility to protect the patients of the risk of~     ventricular arrhythmia with no risk of lead failure. However, as this is a new technology~     and as Brugada syndrome patients are a very specific population (very active patients,~     specific and changing over time ECG aspect that is at risk of T wave over sensing and high~     risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in~     this specific context.~   "
54461|NCT02344264|"~     The patients will be included the 1. or 2. day after surgery. All THA patients will be~     screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to~     participate.~      Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then~     ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be~     45 minutes between the two blockades. The blockades will be ultrasound guided.~   "
54462|NCT02344251|"~     In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a~     significant issue, as rates tend to be low and adherence to medication may predict improved~     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).~     However, methods commonly used to determine compliance may result in inaccurate measurement~     of adherence. In this study, we propose to assess the effectiveness and safety of the~     ID-Cap-M, a novel compliance measurement device, in a healthy population.~   "
54463|NCT02344238|"~     In pharmacotherapy trials in drug-dependent populations, medication compliance is a~     significant issue, as rates tend to be low and adherence to medication may predict improved~     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).~     However, methods commonly used to determine compliance may result in inaccurate measurement~     of adherence. It is therefore essential to develop measurement systems that not only~     accurately and objectively measure compliance, but can also have the potential to increase~     compliance in difficult to treat disorders such as addiction. In this study, we propose to~     assess the acceptability, tolerability, and efficacy of the ID-Cap, a novel compliance~     measurement device, in a healthy population.~   "
54464|NCT02344225|"~     Phase 2, open-label, randomized, multi-center studies in infants and premature infants are~     necessary to determine treatment and preventative strategies for ROP. This study was~     designed to: a) target infants at the highest risk of ROP in a large number of centers with~     variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether~     caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for~     ROP. The study is designed to determine whether the novel treatment regimens are safe and~     potentially effective for ROP prevention and to obtain requisite data for the development of~     a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in~     NICUs as standard of care for ELGANs, no placebo group is included.~   "
54465|NCT02344212|"~     The long-term objective of this study protocol is to develop and test a culturally~     sensitive, community-based intervention, ESENCIAL Para Vivir (Essential for Life) to promote~     weight loss and diabetes prevention among overweight or obese Latina immigrants. We chose to~     focus on Latinas because Latinas are at especially high risk for developing diabetes and~     currently there are not Spanish programs available in our area that provide education about~     weight management and diabetes prevention.~   "
54466|NCT02344199|"~     Beta-blockers should be administered to all patients with heart failure stage II to IV~     according to NYHA.Beta-blockers reduce mortality and hospitalizations and improve the~     operational phase for all categories of patients with heart failure. Since beta-blockers,~     only carvedilol, metoprolol, bisoprolol and recently nevimpololi have shown these benefits~     and so, only they have evidence to be provided.~      Eplerenone is indicated, in addition to conventional therapy, for reducing the risk of~     cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction~     (LVEF ≤ 40%) and clinically proven heart failure after recent myocardial infarction.~   "
54467|NCT02344186|"~     The main objective of the study will be to test the hypothesis that treatment with~     Liraglutide will decrease ER stress and adipose tissue in obese patients with type 2~     diabetes. Experimental Approach: The investigators will use a prospective, single blind,~     placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus~     (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12~     weeks. The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide~     for 24 weeks.~      Measurements: The investigators will determine glycemic control (with HbA1c), body~     composition (bioelectric impedance analysis), insulin sensitivity (with~     hyperinsulinemic-euglycemic clamps), insulin secretion (with oral glucose tolerance~     testing), energy balance (calories in vs. calories out), plasma lipid levels and obtain~     subcutaneous fat biopsies to determine ER stress response markers before and after placebo~     and before and after Liraglutide treatment.~   "
54468|NCT02344173|"~     The purpose of this registry is to assess the performance and clinical effectiveness of a~     combination of SJM mapping and ablation products in the treatment of subjects with atrial~     fibrillation (AF).~   "
54469|NCT02344160|"~     The objective of the study is to demonstrate non-inferiority of stem revision rate in~     subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5~     year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as~     outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.~   "
54472|NCT02344108|"~     Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is~     associated with adverse behavior and quality of life, as well as long term cardiopulmonary~     system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder,~     with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a~     higher incidence of OSA than the general pediatric population, with rates of 30-60%,~     resulting in increased morbidity and decreased quality of life for affected individuals. In~     children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and~     adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A~     for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns~     requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent~     obstruction is attributed to anatomic and physiologic differences in this population,~     including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil~     hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway~     Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved~     under P130008 for the treatment of obstructive sleep apnea, which has already been approved~     for use in adults with OSA, can be safely implanted and used in adolescents and young adults~     with Down Syndrome.~   "
54473|NCT02344095|"~     The investigators aimed to evaluate the safety of weekly paclitaxel with oncothermia and~     weekly cisplatin with oncothermia in patients with recurrent or persistent epithelial~     ovarian, fallopian tube or primary peritoneal carcinoma. This trial is a randomized phase 1~     trial. The investigators planned to perform it for 1 year. In this trial, a total of 12~     patients with recurrent or persistent epithelial ovarian, fallopian tube or primary~     peritoneal carcinoma are randomly assigned to either a paclitaxel or cisplatin group in~     ratio of 1 to 1. Paclitaxel group are treated with weekly paclitaxel and oncothermia.~     Cisplatin group are treated with weekly cisplatin and oncothermia. In each group, limiting~     toxicity is evaluated after treating 3 patients for 4-cycles. Primary endpoint is occurrence~     of limiting toxicity. Secondary endpoints are response rate, progression-free survival,~     overall-survival, quality of life, pain, fatigue and compliance rate.~   "
54474|NCT02344082|"~     This prospective study will include both an intervention and control arm. The control arm~     will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm~     will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a~     hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must~     have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore~     Medical Center (EBMC).~      Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the~     intervention group in which patients participate in telemedicine, to a control group in~     which they do not~   "
54475|NCT02344069|"~     Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage~     needing haemostatic resuscitation - a randomized, controlled, double-blinded~     investigator-initiated pilot trial~   "
54476|NCT02344056|"~     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study~     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch~     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive~     functions in the afternoon. The present Coco study connect this two previous studies and~     investigates the effect of having school lunch versus skipping it on children's basal and~     executive cognitive functions later in the afternoon.~   "
54477|NCT02344043|"~     Purpose of the Study Critical illness requiring life support affects over 150 000 people in~     Ontario every year. With aggressive support, the number of people who die from critical~     illness is decreasing. However, people who survive often have neurological problems. These~     neurological problems often include difficulties with memory, concentration, and attention.~     These problems are associated with poor quality of life among survivors of critical illness.~     The aim of this study is to identify the factors that contribute to these neurological~     deficits. Specifically, the investigators are testing whether changes in oxygen delivery to~     the brain during critical illness are related to both short- and long-term neurological~     complications.~      Procedures involved in the Research When patients are diagnosed with a critical illness such~     as shock or respiratory failure, they are treated with intravenous fluids, medications to~     raise their blood pressure, and can be placed on a ventilator to assist with their~     breathing. They are observed in an intensive care unit (ICU). This research protocol does~     NOT interfere with the normal treatment of patients with critical illness. The procedure~     involved in this research protocol requires the placement of two stickers to either side of~     the patient's forehead, and information about oxygen delivery to the brain will be recorded.~     When the patient has recovered from the critical illness, they will be asked to perform~     several neurological tests. Some of these tests will be done with a pencil and paper, while~     others will use a robotic device to test arm movements, reaction time, and concentration.~      Potential Harms, Risks or Discomforts:~      This research study involves the placement of a sticker sensor to either side of the~     forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor~     patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be~     removed. With regards to the neurological testing, rarely patients can have some mild muscle~     stiffness after moving their arms in the robot. The investigators do not expect any other~     further harms, risks, or discomforts.~   "
54478|NCT02344030|"~     Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal~     CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV~     channeled blade~   "
54479|NCT02344017|"~     The purpose of this first-in-man study is to evaluate safety, tolerability and~     pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate~     cancer.~   "
54480|NCT02344004|"~     A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added~     to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection~     caused by Mycobacterium Avium Complex (MAC).~   "
54481|NCT02343991|"~     The purpose of this study is to evaluate the safety of BBB disruption using transcranial~     MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent~     to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using~     the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic~     safety of this type of treatment as the basis for later studies to evaluate its clinical~     efficacy.~   "
54482|NCT02343055|"~     The overall objective of this study is to evaluate a collaborative self-management~     intervention in patients with moderate to severe COPD in a primary care population. To~     achieve this objective the investigators developed a diagnostic and treatment pathway for~     the management of COPD in primary care that is based on national guidelines and focused on~     patient self-management.~   "
54483|NCT02343042|"~     This study will independently assess the efficacy and safety of two combination therapies~     for the treatment of patients with relapsed/refractory multiple myeloma (RR MM): selinexor +~     dexamethasone + pomalidomide (SdP), selinexor + dexamethasone + bortezomib (SdB), and~     selinexor + dexamethasone + lenalidomide (SdL).~   "
54488|NCT02343926|"~     Primary Objective:~      To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to~     metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.~      Secondary Objectives:~      To compare the safety and tolerability of gemigliptin and vildagliptin:~        -  Number of patients who experience at least one episode of hypoglycemia.~        -  Number of patients experiencing adverse event (AE), serious adverse event (SAE).~        -  Assessment of patients compliance defined as number tablets returned by patients.~   "
54489|NCT02343913|"~     This study is an additional component of protocol 6005, titled Simplifying Menstrual~     Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for~     follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a~     self-assessment checklist that will help women, who receive medical services for incomplete~     abortion, correctly identify warning signs and symptoms and determine whether to return to~     the clinic. The checklist can serve as a useful resource to help with the timely~     identification of women who need additional care and can help streamline service delivery.~     In addition, this study will provide important data on the role of misoprostol at varying~     levels of health services offering an array of treatments for incomplete abortion.~   "
54490|NCT02343887|"~     Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients~     show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms~     impact the compliance of the treatment, though its performance and daily life quality. To~     this day, no therapy tested has proved its efficiency, including the strategy of the~     antiretroviral therapy (cART) optimization according to the Cerebral Penetration~     effectiveness Score (CPE).~      Description of the study: an open prospective comparative monocentric pilote study,~     randomised in three groups which investigates the efficiency of a 6 months-cognitive~     rehabilitation program on improving asymptomatic or minor cognitive disorder for~     undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART~     with a good cerebral penetration who develop asymptomatic or minor cognitive disorders~     connected to HIV infection. Those who have severe psychiatric disorder or who are on~     medication that could interfere with psychometrical tests will be excluded.~      Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months~     period on the evolution of minor cognitive disorders and asymptomatic patients to a control~     group and a group treated with psychological support.~   "
54491|NCT02343874|"~     The prevalence of alcohol-related disorders in the general population is around 10%. The~     relationship between the use of healthcare services, costs and the amount of alcohol~     consumed by the general population is unknown. Because alcoholism is a major public health~     problem, it is significant to determine the prevalence of consumption of primary users and~     the relationship between the dose of alcohol and health care costs. This information may~     allow the implementation of preventive strategies to reduce consumption with the aim to~     reduce morbidity and healthcare expenditure.~      A cross-sectional study will be carried out. Patients over 17 years old, treated at primary~     healthcare centers in Catalonia that have available data on alcohol consumption from January~     2010 to December 2012 will be included. Clinical and sociodemographic data will be~     collected. Health service use and health care costs from 2013 will be collected from SIDIAP~     (The Information System for the Development of Research in Primary Care) database.~      A positive relationship between grams of alcohol consumed per week and the use of resources~     and health expenditure will be expected and also the level of risk of alcohol consumption.~     There will be a descriptive analysis of the clinical data and sociodemographic variables. A~     multivariate analysis will be done to see the relationship between alcohol consumption and~     health care costs and health care service utilization.~   "
54492|NCT02343861|"~     Atopic dermatitis is the most common chronic inflammatory skin disease in children and~     severely affects quality of life (QoL) of patients and their parents. The application of~     topical medications and emollient is the mainstay of the treatment, but complexity of the~     treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic~     failure. Adequate education about the chronic disease and its treatment was known to improve~     the treatment adherence. There are a variety forms like generalized information leaflets and~     video clips for imparting information to patients and individualized tailoring education was~     considered more effective way to improve patients' adherence. The aim of this study is to~     determine the efficacy of tailored education in dermatology area, especially the emollient~     usage in patients with atopic dermatitis.~   "
54493|NCT02343848|"~     The association between physical activity and several complication of pregnancy will be~     evaluated .~   "
54494|NCT02343835|"~     This protocol will study the impact of Irreversible electroporation (IRE) on immune response~     in patients diagnosed with unresectable pancreatic cancers smaller than 5.0 cm. It will~     profile the immune response to IRE of unresectable pancreatic cancers. The intra-tumoral and~     systemic immune response to IRE will be determined and compared to pre-ablated pancreatic~     cancer specimens and historical control specimens.~   "
54495|NCT02343822|"~     To determine the ideal dose of PRP for lateral epicondylitis. To see if 2 PRP injections are~     better than a single PRP injection or a saline injection to improve function and pain in~     patients with lateral epicondylitis.~   "
54505|NCT02343692|"~     Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their~     abdomen without pancreatic symptoms are found to have an incidental pancreatic cyst, with~     the frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic~     cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are~     currently either observed or removed surgically according to international guidelines.~     Observation is associated with significant anxiety for patients and a growing cost to the~     National Health Service, while surgery for this usually benign condition is associated with~     not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for~     a number of years before malignant transformation, creating a window of opportunity for~     minimally invasive intervention and cure. New early treatment options for premalignant~     tumours are urgently required. This study will evaluate the safety and efficacy of a novel~     minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic~     ultrasound guided radiofrequency ablation (EUSRFA).~      If successful it will offer an alternative to long term observation or surgery for patients~     with this condition.~   "
63099|NCT02231359|"~     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for~     inhalation in patients with chronic obstructive airways disease in daily practice~   "
54496|NCT02343809|"~     Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to~     the mechanical pain of the locomotor system. In our clinical practice a favorable effect is~     observed in patients with chronic lateral epicondylitis, but there are no published studies~     evaluating the results of this technique.~      The objective of this trial is to evaluate if DF provides a further improvement in pain~     intensity, pain-pressure threshold, function and pain-free grip strength, in patients with~     chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct~     a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care~     Center.~      Sixty subjects will be randomized (computer application) into three groups: Intervention~     Group, Placebo Group and Control Group. All the three groups receive the same protocolized~     treatment of physiotherapy and additionally. Additionally, the Intervention Group receives~     six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group~     receives six sessions (two sessions in a week during three weeks) of sham DF. The Control~     Group receives the protocolized treatment of physiotherapy only.~      Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH~     questionnaire) and pain-free grip strength (digital dynamometer) will be measured at~     baseline, after treatment period, and three months after discharge from treatment. After~     discharge for treatment the patient subjective opinion about their evolution will be~     collected through the Global Rating of Change (GROC) scale.~   "
54497|NCT02343796|"~     The purpose of this study is to determine whether fibre-reinforced composite resin~     restorations are effective for single tooth replacement, elimination of tooth mobility~     following periodontal treatment and as an orthodontic retainer.~   "
54498|NCT02343783|"~     The purpose of this study is to characterize the cell (the basic building block of all~     living things) populations and inflammatory (pain and swelling) mediator responses in~     suction skin blister fluid after allergic skin reaction (ASR) [rash] induction with D.~     Pteronyssinus [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus~     allergens in participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma~     (AA) [breathing disorder in which there is a wheezing and difficulty breathing].~   "
54499|NCT02343770|"~     Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The~     etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular~     JIA with antinuclear antibodies affects about half of all children. There 's no specific~     markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human~     Protein Microarray allows rapid and efficient detection of protein interaction using a~     suitable protein or small molecule probe. The investigators hope so detect novel potential~     autoantigen biomarkers specific in JIA.~   "
54500|NCT02343757|"~     The early detection of a preclinical AD or early stage of AD with amyloid imaging could~     improve the diagnosis and provide knowledge for better therapeutical approach by combining~     the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid~     PET imaging, all these two techniques with their strengths in one machine.~      Specific Aims and Hypotheses can be summarized as follows:~        1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI,~          including direct comparison to corresponding PET/CT images of the same patients.~        2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to~          2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque~          burden correlate with degree of neuronal degeneration as depicted by FDG as well as~          with clinical severity?~        3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form~          PET/CT and from PET/MR) using novel software developed specifically for these brain~          application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid~   "
54501|NCT02343744|"~     The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in~     participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).~   "
54502|NCT02343731|"~     Studies show that family members share as much or more of the composition of their~     microbiota (the trillions of micro-organisms in our guts) with their dogs as they do with~     each other (Song et. al. 2013). This shows that the introduction of dogs into home~     environments has a profound impact on the human microbiota. Additionally, many studies show~     that children raised with dogs are less likely than others to develop a range of~     immune-mediated disorders, including asthma and allergies (Ownby, Johnson, and Peterson~     2002; Almqvist et al. 2003; Havstad et al. 2011). This suggests that dogs can serve as~     probiotics for children by appropriately training their immune systems not to produce~     inflammation in response to harmless stimuli. What is not known, however, is whether the~     same is true for elderly populations and dogs. Thus, this study seeks to explore whether~     dogs might also improve the physical and mental health of elderly adults by improving the~     structure and function of their microbiota. The investigators propose a pilot/proof of~     concept study to investigate whether dogs might improve the physical and mental health of~     elderly adults via changing (improving) the structure and function of their microbiota (gut~     flora). The investigators propose a pre-post study design that among 20 elderly individuals~     (aged 50 and older) to investigate the probiotic effect that dogs might have on these~     individuals. The investigators are particularly interested to know whether introducing a dog~     into a home where one has not lived in the recent past increases the positive~     microorganisms in the guts of the humans living with them. The investigators will also~     measure the changes in markers of inflammation (from blood samples) as well as the changes~     in self-reported scores of depression, frailty, physical activity, and general health and~     well-being mobility among human participants. In order to assess any effects in the animal~     study participants, the investigators will also collect and analyze fecal and blood samples~     as well as conduct home visits to observe canine and human interactions and bonding and~     conduct assessments of canine well-being using questionnaires/observational techniques that~     have been validated for these purposes in other studies. Additionally, the investigators~     will assess the interactions between of the participants with the dog and how having a dog~     in the home may influence an individual's relationship with the dog and his/her thoughts~     about the microbiota, human and canine health and human-animal interactions through monthly~     semi-structured interviews.~      The investigators have previously received IACUC approval for this study, approval number~     14-537.~   "
54503|NCT02343718|"~     The purpose of this study is to determine the best dose of vinblastine that can be given~     with a new drug, temsirolimus.~   "
54504|NCT02343705|"~     The objective of the Latella-2 study is to demonstrate the safety and efficacy of the~     Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.~   "
54518|NCT02343523|"~     The present study proposes to utilize a novel, wearable device, QI Device, which has~     multiple sensors embedded in a wrist-watch in order to explore its monitoring capabilities~     in individuals with congestive heart failure.~   "
54519|NCT02343510|"~     PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is~     compared to cases of high grade serous ovarian cancer and normal tubes .~   "
54520|NCT02343497|"~     The purpose of this study is to investigate whether astaxanthin supplementation can impact~     triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.~   "
64162|NCT02217475|"~     The purpose of this study is to determine whether Cenicriviroc is effective and safe in the~     treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.~   "
54506|NCT02343679|"~     This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref~     hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim~     analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at~     least one dose of study drug will be evaluable for safety. Only subjects who complete at~     least 1 cycle of study drug and have clear progression on physical exam or have had at least~     one restaging study will be considered evaluable for response. Each subject will receive the~     same dose of 750mg po daily at the study entry. Subjects with stable disease or better will~     be allowed to continue study drug until disease progression or until intolerable adverse~     events or patient or physician decision. Intrapatient dose reductions will be allowed for~     adverse events. This is a multicenter study with Duke as the lead site. Blood and tissue~     samples, will be collected and used for exploratory analysis.~   "
54507|NCT02343666|"~     This pilot phase I trial studies the side effects and best dose of human immunodeficiency~     virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are~     undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are~     collected from the patient and HIV-resistance genes are placed into the stem cells. The stem~     cells are then re-infused into the patient. These genetically modified stem cells may help~     the body make cells that are resistant to HIV infection.~   "
54508|NCT02343653|"~     The purpose is to investigate the effect of strength training on muscle strength, muscle~     mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic~     and inflammatory changes during this intervention. In addition the investigator examine if~     the intervention is associated with fewer hospital readmission and an improved quality of~     life.~   "
54509|NCT02343640|"~     The purpose of this study is to use ultrasound imaging to determine if there are certain~     frequencies, durations, and intensities of baseball pitching that expose a college baseball~     player to increased risk of injury to their ulnar collateral ligament of their elbow~     throughout one baseball season.~   "
54510|NCT02343627|"~     This study will examine the safety, tolerability and efficacy of NVXT in a new formulation~     in patients with mild-to-moderate fungal infection of the toe nail.~   "
54511|NCT02343614|"~     The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the~     variable natural history of the disease. Although contemporary treatment options are~     limited, new targets and new approaches are under investigation for preventing bladder~     cancer recurrence and progression. Among those, COX-2 is a promising target since plays an~     important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib,~     effectively inhibit tumor development and growth and enhances survival, in bladder cancer in~     vitro and in vivo models.~      Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in~     patients with intermediate risk NMIBC.~   "
54512|NCT02343601|"~     The purpose of this study is to determine whether hemodynamic optimization with~     photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal~     surgery could decrease the incidence of perioperative complications.~   "
54513|NCT02343588|"~     The study was designed as a national multi-centered cluster randomized controlled trial~     involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in~     China. In each center, about 12-16 primary and secondary schools, with totally at least~     10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected~     schools were randomly allocated to either intervention or control group (Intervention:~     Control=1:1).The multi-components school-based and family-involved scheme was conducted~     within the intervention group for 9 month, while students in the control group followed~     their usual health practice. The intervention consisted of four components: a) Create~     supportive school and family environment, b) Health lifestyles education and related~     compulsory physical activities, c) Instruct and promote school physical education, d)~     Self-monitor obesity related behaviors. Four types of outcomes including anthropometric,~     behavioral, blood chemical and physical fitness were measured to assess the effectiveness of~     the intervention program.~   "
54514|NCT02343575|"~     Delirium is the most often encountered psychiatric diagnosis in the general hospital, with~     incidence up to 85% in the intensive care unit (ICU) setting and with significant~     consequences on patients' morbidity and mortality. Currently, although not FDA approved,~     antipsychotics are often considered the first-line pharmacological treatment. However, there~     can be limitations to their use, including side effects or lack of efficacy. Valproic acid~     (VPA) is one of the alternatives at times used in such patients which from limited case~     series data appears to be helpful and tolerated. VPA can provide relief from agitation that~     poses a threat to the safety and recovery of the patient. Moreover, mechanistically it~     addresses the neurochemical and cellular abnormalities inherent in delirium (it has~     NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone~     deacetylase inhibitor properties, among others). The purpose of this study is to evaluate~     the efficacy and tolerability of the VPA in the first known to us randomized controlled~     trial.~   "
54515|NCT02343562|"~     Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The~     objective of the trial is to prevent postoperative HAEC by using Probiotics.~   "
54516|NCT02343549|"~     All patients will complete best standard of care radiation, temozolomide and bevacizumab (6~     weeks). Within two weeks of completion of this initial treatment period, study patients will~     be fitted with the NovoTTF-100A System and treated continuously. They will be treated with~     TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a~     treatment break for a total of 3 days per month, for each month and still be in compliance.~     This will consist of wearing four electrically insulated electrode arrays on the head. The~     patients will also continue with maintenance temozolomide/ bevacizumab.~   "
54517|NCT02343536|"~     The goal of the study is to identify a dose and schedule of CC-486 that can be safely~     administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the~     maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more)~     previously untreated DLBCL or Grade 3B FL.~      Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in~     combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007~     International Working Group (IWG) criteria.~   "
54521|NCT02343484|"~     Many different minimally invasive techniques have been used for the treatment of chronic~     discogenic low back pain refractory to conservative treatments, with various results. The~     aim of this study is to assess the efficacy of the combination of intradiscal pulsed~     radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of~     life of patients sufferring from chronic discogenic low back pain.~   "
54522|NCT02343471|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate the effect whey protein consumed as pre-meal prior~     to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects~     with type 2 diabetes compared to healthy subjects. Secondarily the aim is to study the~     responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate~     of gastric emptying and metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich~     isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects~     compared to healthy subjects.~      The investigators research will hopefully contribute to a better understanding of how PPL~     can be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular.~     Thus, the results of this project can impart knowledge of great importance both to the~     national and international food industry as well as the healthcare systems.~   "
54523|NCT02343458|"~     A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group,~     multi-center study to assess the efficacy and safety of glycopyrronium and formoterol~     fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF;~     PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very~     severe COPD, compared with placebo.~   "
54524|NCT02343445|"~     The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine~     whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater~     effect on lung function in patients with CF than placebo (0.17% saline).~   "
54525|NCT02343432|"~     This study was aimed to investigate the impact of using different epidural volumes.~      Patients with acute discogenic pain were included in the study.~   "
54526|NCT02343419|"~     The aim of the study is to compare standard spirometric evaluation of methacholine challenge~     test with plethysmographic, interrupter technique and forced oscillation technique (FOT)~     evaluation of the airways resistance.~      The study group will consist of patients referred for methacholine challenge test. All~     patient will undergo spirometric, plethysmographic, interrupter technique and FOT~     examinations - before and after inhalation of aerosols. Patients will also undergo the~     measurement of nitric oxide concentration in exhaled air and laboratory tests, including:~     blood count, measurement of serum C-reactive protein, sodium, potassium, creatinine,~     immunoglobulin E and N-Terminal pro-brain natriuretic peptide (NT-proBNP) concentration.~      The investigators intend to assess, if plethysmographic, and/or interrupter, and/or FOT~     measurement of bronchial reactivity can replace standard spirometric assessment.~     Plethysmography, interrupter technique and FOT are much more easier to perform for patients.~     Furthermore, those two techniques are less dependent on patient's motivation and cooperation~     ability. Thus, usage of FOT, interrupter technique and/or plethysmography in bronchial~     hyperreactivity testing could make methacholine challenge test more comfortable and~     available for more patients. The investigators are also going to analyze the relationship~     between exhaled nitric oxide and functional indices of bronchial hyperreactivity.~   "
54527|NCT02343406|"~     This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide~     versus temozolomide or lomustine alone in participants with recurrent glioblastoma~     multiforme.~      The study includes a Pediatric sub-study to evaluate safety, tolerability and~     pharmacokinetics of ABT-414 in a pediatric population.~      Adult enrollment has been completed and the study is now only recruiting for pediatric~     participants.~   "
54528|NCT02343393|"~     This is a single-blind, randomised, clinical trial assessing the efficacy of Hydralazine and~     Isosorbidedinitrate combination (oral agents) in HF patients with renal dysfunction.~   "
54529|NCT02343380|"~     The investigators aim at analyzing whether eating a standard meal in the evening (at 8:00~     pm) determines in the same individuals a lower diet-induced thermogenesis (DIT) and a~     different hormonal response than the consumption of the same meal in the morning (at 8:00~     am).~      The primary outcome is: the intra-individual variation in DIT after the evening and morning~     meal consumption.~      The secondary outcomes are the intra-individual variations in glucose, triglyceride,~     insulin, free fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin,~     noradrenalin, after the evening and morning meal consumption.~   "
54558|NCT02342964|"~     Non-invasive methods of the quantification of fibrosis may help to assess the development of~     fibrosis at a specific moment of the evolution of the disease, in the order to decide the~     initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic~     cirrhosis:~        -  FibroTest,~        -  The ultrasound impulse elastography, Fibroscan (FS)~        -  Ultrasound Elastography by ShearWave (SWE)~        -  Magnetic resonance elastography (MRE). The purpose of this study is to assess the~          contribution of these methods in the diagnosis of hepatic fibrosis during the evolution~          of the cystic fibrosis.~   "
54559|NCT02342951|"~     The purpose of this study is to determine the efficacy of a non invasive method of detecting~     the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as~     possible.~      Moreover this screening procedure permits to note the improvement following the treatment~     and to choose the optimal treatment in term of efficacy.~   "
54665|NCT02341573|"~     The purpose of this study is conducting a randomized, single blind, controlled intervention~     trial to observe the therapeutic effect of experienced chinese herbal formulas based on~     different stages and different symptoms in pediatric asthma.~   "
54530|NCT02343367|"~     The H4K Trial is a randomized controlled trial to improve children's body composition by~     testing a comprehensive, culturally and linguistically relevant, family-oriented~     intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric~     clinics in San Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric~     obesity management intervention (physician counseling plus telephone counseling, newsletters~     and text messages) compared to standard care (physician counseling only) on three outcomes:~     1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and~     cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and~     consumption of sugary beverages and fruits and vegetables. The investigators will recruit~     230 overweight and obese children—and a parent or guardian for each—and randomize them to~     the H4K intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent~     dyads). The investigators hypothesize that intervention children will significantly improve~     their body composition, increased their PA levels and diet quality (more fruits and~     vegetables and less sugary beverages), and decrease their sedentary activity, compared to~     children in standard care. If successful, this study will generate new scientific knowledge~     about effective Hispanic family-based approaches for obesity prevention with high potential~     for replication in underserved areas across the nation.~   "
54531|NCT02343354|"~     Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes;~     their children show more insulin resistance and diabetes compared to offspring of mother~     without diabetes in pregnancy. An increased diabetes risk is also observed among partner of~     adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for~     diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The~     investigators are now enhancing the program to engage directly the partner (MoMMii program).~      In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal~     diabetes prevention program that includes healthy meal preparation training, discussion of~     eating and physical activity behaviours and developing home environments that facilitate~     healthy habits, pedometer-based step count monitoring, and participation in family-based~     activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise~     equipment, floor resistance exercises). Participants will be encouraged to communicate~     between sessions with study personnel and with one another to create a between family~     support network. All mothers and fathers will participate in five sessions over six months.~     The investigators will examine changes in health-related behaviours, blood pressure, glucose~     levels, and insulin sensitivity/resistance in both mothers and fathers.~   "
54532|NCT02343341|"~     Project 1. Primordial/primary behavior change in children~      Problem: Childhood obesity has more than doubled over the past 30 years, with nearly~     one-third of children aged 6 to 11 years being obese. These children are more likely to~     become obese adults and are at a higher risk for the development of diabetes, hypertension,~     heart disease and cancer.~      Approach: This research tests the hypothesis that habits are formed very early in life and~     that children can help their parents live healthier lives. The investigators attempt to test~     this hypothesis by evaluating the impact of an educational program focusing on diet,~     physical activity, knowledge of the human body, and management of emotions for preschool~     children aged 3 to 5 years, their parents/caregivers and teachers. The investigators will~     first assess the environmental factors, facilitators, and barriers to implementation of a~     health promotion educational program tailored for preschoolers in Harlem, New York. This~     information will be used to tailor the educational program for the children in Harlem. The~     investigators will evaluate the effectiveness of the program in children aged 3 to 5 years~     by randomly assigning blocks of schools to an up to 5-month educational and playful health~     promotion intervention or to usual curriculum. The program will also have components for~     teachers and parents of these children in order to make their learning environment conducive~     to positive change. The impact of our program will be assessed on children's knowledge,~     attitudes, habits, weight, exercise and diet using simple questionnaires and measurements.~      Impact: The investigators expect to demonstrate a positive impact on knowledge, attitudes~     and habits in preschool children in an under-served population. Also aim is to demonstrate~     that this early educational program can increase the proportion of preschool aged children~     with normal weight. This approach has the potential to meaningfully modify the projected~     rise in obesity and cardiovascular disease by affecting an entire generation of children.~     The investigators believe that the healthy habits that the children will acquire through~     this program will lead them to be healthier adults. Thus, the mission aligns closely with~     the American Heart Association's mission of, Building healthier lives, free of~     cardiovascular diseases and stroke.~   "
54533|NCT02343328|"~     The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo~     capsules in subjects with TWO episodes of C. difficile. The investigators have numerous~     subjects and physicians requesting FMT at the time of a second relapse, in order to prevent~     further hospitalizations, obtain a faster and more durable cure, avoid costly medications~     like fidaxomicin and oral vancomycin, and fix the underlying dysbiosis. In some instances,~     subjects feel like they are being asked to get sick again before they can pursue the most~     effective option. The investigators propose to study these subjects with a rigorous placebo~     controlled design, which will contribute significantly to our understanding of the utility~     of FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who~     relapse with placebo will by definition have a third episode, meet consensus criteria for~     FMT, and will be offered standard FMT by capsule at that time. Additionally, this study~     will allow us to further capture safety data, in comparison to placebo capsules and further~     enhance our understanding of the microbiology of dysbiosis, earlier on in the illness~     course. Lastly, the investigators may decide to perform a cost analysis.~   "
54534|NCT02343315|"~     The purpose of this study is to compare the added effects of TENS and Supervised Motor~     Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain~     and other outcomes.~   "
54535|NCT02343302|"~     A very common complication following distal pancreatectomy is leakage from the pancreas, or~     what is called a pancreatic fistula. We hypothesize that operative drains which create~     suction may contribute to the development of leakage from the pancreas. This study evaluates~     the effect of using non-suctioning drains to prevent the development of this complication.~   "
54536|NCT02343289|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     esketamine administered by the intranasal (administered through the nose) and oral routes~     and to evaluate the effects of clarithromycin on the pharmacokinetics of intranasally~     administered esketamine.~   "
54537|NCT02343276|"~     Single-center study, randomized, double-blind, placebo controlled, with patients undergoing~     diagnostic or therapeutic catheterization via the transradial approach. Patients will be~     randomized into two groups: one group will receive the vasodilator nitroglycerin during the~     procedure (intervention group), and a second group will receive saline 0.9% in the same~     volume and time during the procedure (control group).~      Will be evaluated: incidence of spasms of the radial artery, ability to perform the~     procedure without the need to change the access site, pain presented by the patient, time~     and total radiation of the procedure.~   "
54538|NCT02343263|"~     The purpose of this study is to evaluate the effect of combining two interventions already~     in use at some institutions for reducing post-operative pain following tonsillectomy or~     adenotonsillectomy. The standard of care at most institutions is to leave the tonsillectomy~     wound bed exposed to heal on its own over one to two weeks. At many institutions, surgeons~     inject or topically apply local anesthetics such as bupivacaine hydrochloride to the~     tonsillectomy wound bed to help reduce post-operative pain. At other institutions, surgeons~     apply a layer of fibrin sealant, which is derived from the proteins that help form blood~     clots in blood, to the tonsillectomy wound bed in order to cover the site and reduce~     irritation and exposure of the wound bed. Use of fibrin sealant has the additional benefit~     of potentially reducing postoperative bleeding (hemorrhage) rates. Both the~     post-tonsillectomy use of bupivacaine (injection and topical) and the use of topical fibrin~     sealant application have been studied previously in the scientific literature; some studies~     show a clear benefit, others show no significant reduction in pain when they are used. No~     studies have documented harm. The purpose of this study is to evaluate the efficacy of~     infusing bupivacaine anesthetic into the fibrin sealant prior to application to the~     tonsillectomy wound bed. In this way, the combined product would function as a sort of~     medicated bandaid covering the painful wound bed and slowly delivering an entirely safe~     total dose of bupivacaine into the wound bed to reduce post-operative pain. Parents will be~     provided post-operative pain measurements to complete during the first 10 postoperative days~     and return to the researchers for data analysis.~   "
54539|NCT02343250|"~     A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the~     Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and~     Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers~   "
54540|NCT02343237|"~     The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic~     treatment on patients with fibromyalgia.~   "
54541|NCT02343224|"~     This is a phase II study of the drug, pegylated interferon alfa-2b (PEG-IntronTM), used to~     treat brain tumors in a pediatric population. Researchers want to see if treatment with~     PEG-IntronTM will stop tumor growth for patients with juvenile pilocytic astrocytomas or~     optic pathway gliomas.~      The purposes of this study are:~        -  To learn more about the response to pegylated interferon~        -  To learn more about the side effects of pegylated interferon~        -  To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or~          Optic Pathway Gliomas.~        -  To learn more about quality of life in patients treated with pegylated interferon~   "
54542|NCT02343211|"~     Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly~     attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic~     disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour~     treatment. Because of an initial inflammatory stage early in the evolution of the PNS~     several immunotherapy modalities have been tried. Intravenous human immunoglobulins could be~     expected to provide a stabilization or even improvement of PNS, if administered early enough~     to prevent permanent neuronal damage.~   "
54543|NCT02343198|"~     The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following~     total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range~     of motion, lower limb swelling, walking speed, quality of life, activities of daily living,~     device usability, device compliance, activity levels, and pain (VAS).~   "
54544|NCT02343185|"~     This study is a double-blind randomized clinical trial with two arms which aims to study the~     effects of diaphragmatic treatment in patients with nonspecific low back pain.~      Low back pain has a great importance in today's society, and it is therefore important to~     develop an effective treatment for this condition. People with chronic nonspecific low back~     pain, can present respiratory disorders and get anxiety states, affecting mainly the~     diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be~     part of the development of chronic low back pain. Although clinical practice guidelines for~     chronic low back pain have been developed, it hasn't been explored before a physiotherapy~     treatment especially aimed at a diaphragmatic treatment.~      A double-blind randomized clinical trial with two arms will be used for this purpose, 64~     patients with nonspecific low back pain referred from different hospitals of Castellón will~     be randomized into two groups:~        -  Diaphragmatic intervention with osteopathic manual therapy treatment (D).~        -  Diaphragmatic intervention with placebo treatment group (P).~      An osteopathic manual therapy protocol for the treatment of back pain including techniques~     for the diaphragm muscle will be applied to the patients in group D, in a total of 5~     sessions. For patients in group P, the same protocol will be performed on the diaphragm but~     with placebo treatment techniques.~      The study focuses on the analysis of the following variables: scores on the questionnaires:~        -  Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).~        -  Fear Avoidance: (FABQ)~        -  Disability: Oswestry Disability Index and Roland-Morris~        -  Anxiety: HADS: (Hospital Anxiety and Depression Scale)~        -  Catastropizing: PCS (Pain Catastropizing Scale)~        -  Satisfaction with treatment (Escala de Satisfacción con el tratamiento)~      The results of these pre-intervention and post-intervention variables will be compared~     between the two groups in the first session, in the fourth session and in the first and~     third month after the first intervention. The VAS score will also be assessed in the second~     and third session.~   "
54545|NCT02343172|"~     To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the~     combination is safe and has beneficial effects in patients with liposarcoma.~   "
54546|NCT02343159|"~     The primary objective of the study is to determine whether a MEMS® cap with a LCD reader (a~     smart cap) along with additional patient counseling intervention (Arm 3) can improve~     adherence to dimethyl fumarate (DMF) treatment in MS patients as compared to a MEMS~     (Medication Event Monitoring System) cap without a LCD reader (a standard cap) and no~     patient counseling intervention (standard of care, Arm 1) at Month 12.~      The secondary objectives of this study in this study population are: To determine if data~     display on a smart MEMS cap with a LCD reader (Arm 2) can improve adherence as compared to a~     standard MEMS cap without a LCD reader (Arm 1) at Month 12; To determine whether the~     addition of patient counseling intervention based on MEMS data (Arm 3), or data display from~     a MEMS cap with LCD reader (Arm 2) can improve adherence compared to standard MEMS cap~     without a LCD reader (Arm 1) at Month 6; To assess persistence and compliance at Months 6~     and 12 for all arms; To assess the association between adherence and patient reported~     outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the~     Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.~   "
54568|NCT02342834|"~     The purpose of this study is:~        -  to measure the size of the effect on glucose tolerance of a small mixed protein and~          lipid meal given as a pre-load in individuals with different glucose tolerance status~        -  to investigate the underlying mechanisms by accurately evaluating beta cell function,~          insulin sensitivity, insulin clearance and glucose kinetics (oral absorption,~          endogenous production, rate of utilization) together with gut hormones plasma~          concentration.~   "
54569|NCT02342821|"~     This Study will attempt to provide information / linkage to HBV care for persons at risk in~     the Greater Boston area.~   "
54547|NCT02343146|"~     The incidence of type 1 diabetes (T1D) in young children (age <5 years) is rising. The~     burden of responsibility for disease management rests on parents and caregivers to check~     blood sugar, administer insulin, and monitor diet and physical activity to maintain tight~     glycemic control. This occurs at a vulnerable time in life when children's behavior is~     unpredictable, their T1D is difficult to control, and parenting stress is elevated. Despite~     behavioral interventions that have demonstrated success in reducing rates of parent stress~     and improving child behavior, improvements in young children's glycemic control has not been~     sufficiently achieved. The investigators' research will attempt to achieve this goal through~     the development and pilot of an innovative behavioral intervention for T1D in parents of~     young children. The focus of the intervention is on improving young children's nutrition and~     physical activity through the use of parent consultants and delivery of intervention through~     phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary~     caregivers of young children (<5 years) diagnosed with T1D for at least 6 months will~     receive the intervention and then be assessed at 3- and 6- months post baseline on indices~     of behavior and glycemic control (including continuous glucose monitoring). Participants~     will also complete in-depth surveys to provide qualitative as well as quantitative data. At~     the end of Phase 1, the data will be analyzed and used to develop the intervention further~     for Phase 2. During Phase 2, 60 participants and their children will be randomized to either~     the revised intervention (treatment) or usual care (control) condition. Intervention~     components include: T1D management support delivered by trained lay parent consultants, and~     T1D parenting strategies specific to improving eating and physical activity behaviors~     delivered by bachelor's level behavioral assistants via telephone and text messaging.~     Biomedical and psychosocial measurements (including HbA1c, physical activity, nutrition,~     mealtime behavior, parenting stress, quality of life) will occur at baseline and 3- and~     6-months post baseline. The results of this work will ultimately lead to a program which can~     improve young children's T1D management and glycemic control that can be translated into a~     variety of clinical practice settings.~   "
54548|NCT02343133|"~     The purpose of this study is to determine whether HemaMax is safe and well tolerated to~     support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated~     with the hematopoietic syndrome of acute radiation syndrome.~   "
54549|NCT02343120|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-3111 in patients with B-Cell Lymphoid Malignancies.~   "
54550|NCT02343107|"~     Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require~     personalized nutritional monitoring. Today, it is not always possible to provide patients~     with appropriate care to both, the diet plan, physical activity, stress and sleep~     management. Emerging data have shown the effectiveness of remote support (e- coaching), in~     order to increase the level of physical activity and reducing calorie intake which causes~     weight loss similar to that obtained during a face to face consultation. Compared to a food~     survey conducted by a dietician, the dietary survey MXS computer software showed similar~     results on the collection of nutritional data. Furthermore, users preferred this method of~     remote collection compared to direct interview. The investigators recently developed a tool~     for e-coaching combining this computerized dietary survey and education and support modules~     on diet and physical activity (MXS- health program) for the patients. The aim of the~     investigators' study is to compare efficacy of this new software vs usual care.~   "
54551|NCT02343094|"~     The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2~     urinary expression in proteinuric patients.~   "
54552|NCT02343081|"~     The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and~     extent of absorption of Temozolomide after the administration of the study product~     (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in~     primary Central Nervous System patients.~   "
54553|NCT02343029|"~     Physical activity exerts a variety of long-term health benefits in older adults.This~     randomised controlled trial investigates the effect of a 12-week physical exercise program~     on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic~     Imaging. Follow-up lasts for 6 months.~   "
54554|NCT02343016|"~     The aim of the investigators work is to describe the agreement between NIRS and ecodoppler,~     as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative~     period in pediatric patients.~   "
54555|NCT02343003|"~     This study is designed to:~        -  Determine the effectiveness (primarily measured by pain relief) of Coolief when used to~          create radiofrequency lesions of the genicular nerves compared to pain relief following~          corticosteroid injection; and~        -  Confirm the safety of Coolief when used to perform radiofrequency lesions of the~          genicular nerves in subjects to manage knee pain compared to safety of corticosteroid~          injection~   "
54556|NCT02342990|"~     Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral~     ventricles of the brain occurring in the prenatal period, associated with a disorder of~     movement and posture, known as bilateral cerebral palsy. Children with PVL and bilateral~     cerebral palsy have spared verbal abilities, as measured by verbal Intelligence Quotient~     (verbal IQ) tests, while non-verbal intelligence and especially visuo-perceptual and~     visuo-spatial abilities are impaired. In addition some studies underline the impact of PVL~     also on executive function, especially in terms of working memory and in the ability to~     inhibit distraction.~      Working Memory is the ability to retain and manipulate information for brief periods of~     time. It is important in several complex cognitive functions, such as academic learning and~     in planning and organizing daily life activities. School-based activities, indeed, such as~     math and reading depend on a student's ability to pay attention to several instructions or~     information and to hold and integrate them in their mind.~      Recent behavioural and neurofunctional studies describes the effect of an evidence-based and~     computer-based training on working memory, the Cogmed Working MemoryTraining. Functional MRI~     show increase in parietal and prefrontal activity after this training, while the behavioural~     data demonstrate the generalization of this effect also on cognitive functions not directly~     trained, as attention, inhibition, learning and non-verbal reasoning. Cogmed Working~     MemoryTraining (RoboMemo®, CogMed-Cognitive Medical Systems, Stockholm, Sweden) is an online~     treatment comprising a number of visuo-spatial and verbal exercises that vary automatically~     depending on the individual child's performance in any given task. The training period is~     intensive and includes 25 home session for five weeks, 30-45 minutes each day. A~     Cogmed-trained coach monitors training progress and participants' commitment daily.~      Only one ongoing study has used the CogMed training in children with cerebral palsy, but~     without investigating the correlation between behavioural findings with neurofunctional~     data.~      The aim of this study is to analyze the effect of the working memory training with CogMed on~     trained and not directly trained cognitive abilities and on the changes in cortical~     electrophysiological reorganization during the sleep after training. The sleep analysis will~     be focused in particular on the slow waves activity [frequency range of 1-4.5 Hz] and on the~     sleep spindle [frequency range of 12-14Hz], which reflect the depth of sleep and are related~     to memory processes, learning and brain plasticity.~      The results of this project will shed light on the mechanisms of neuroplasticity, by~     enhancing knowledge on the neuropsychological effects of a specific working memory training~     and on the neurophysiological underpinnings of these behavioural effects in a clinical~     population of children with congenital brain lesions, as PVL.~   "
54557|NCT02342977|"~     The purpose of this study is to determine how effect lacosamide is in reducing the amount of~     pain medication needed following a total hip arthroplasty. The study team hypothesizes that~     a single dose of lacosamide will reduce the amount of pain medication required after~     surgery. The study team plans to evaluate the amount of pain medication needed and quality~     of pain control during a subject's hospital stay and at their three month follow-up visit~     following their surgery.~   "
54666|NCT02341560|"~     This study will determine the effect of QPI-1007 on visual function in subjects with~     recent-onset NAION and assess the safety and tolerability of intravitreal injections of~     QPI-1007 in this population. This study will also evaluate the structural changes in the~     retina following administration of QPI-1007.~   "
54560|NCT02342938|"~     The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with~     either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients~     suffering from drug-resistant partial epilepsy, and 2) define the functional organization of~     neural networks underlying human perception and cognition in order to prevent inadvertent~     deficits resulting from neurosurgical resection. In particular, high-frequency activity~     (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for~     both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and~     MEG require further investigation. This will be a pioneering effort in several respects, as~     the first to directly measure high-frequency neural activity in tandem with fMRI, and among~     the first to do so with MEG. In addition to their attractiveness as noninvasive imaging~     techniques, fMRI and MEG have the potential to examine whole-brain networks that are not~     accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of~     simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the~     two noninvasive techniques, providing compelling evidence for the links between all three~     measurements with respect to underlying high-frequency neural activity in both health and~     disease. This project will therefore lead to improved selection of epilepsy surgery~     candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and~     healthy brain networks. The same techniques will be immediately applicable to functional~     mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of~     neurological and psychiatric populations.~   "
54561|NCT02342925|"~     This single-center, non-randomized, open-label, two treatment, two period, fixed sequence~     crossover study will investigate the effect of RG1662 treatment on the activity of key renal~     transporters in healthy male and female participants using metformin. The effect of RG1662~     on other renal function parameters will also be explored.~   "
54562|NCT02342912|"~     This is a randomized trial designed to translate and deliver programs via social media for a~     healthy body weight to university students. Specifically, in this trial, we will randomly~     assign 450 overweight/obese (BMI between 25-45kg/m2) university students (ages 18-35)~     enrolled at two colleges (George Washington University and University of~     Massachusetts-Boston) to one of two social media weight loss treatments (personalized or~     generic) or a contact control. The social media treatments consist of Facebook groups to~     provide social support, connectedness and intervention content, as well as daily text~     messages. Assessments will be conducted at baseline, 6, 12, and 18 months post baseline,~     with the primary outcome being weight loss at 18 months. We hypothesize that: a) Tailored~     Social Media will lose significantly more weight at the above time points compared with~     Targeted Social Media. b) Both the Tailored Social Media and Targeted Social Media groups~     will have greater weight loss at the 6, 12, 18 month follow-ups than Contact Control. The~     secondary aim is to evaluate changes in metabolic risk factors among those participants who~     have maintained at least 5% weight loss at 18 months. We hypothesize that participants who~     achieve a 5% weight loss at 6 and 18 months will have significantly lower triglycerides,~     higher HDL cholesterol, and lower blood pressure than those who do not achieve and maintain~     that weight target. Finally, we will conduct additional formative work to evaluate the~     implementation feasibility of this intervention on college campuses, including an assessment~     of costs as well as the sustainability infrastructure using the PRISM (Practical, Robust~     Implementation and Sustainability Model) model as a guide. The results of this study have~     the potential to significantly impact the delivery of obesity treatment services on college~     campuses.~   "
54563|NCT02342899|"~     Obesity is an escalating issue, with an accompanying increase in referrals of patients with~     obesity-related respiratory failure. Currently, these patients are electively admitted to~     hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether~     outpatient initiation is as effective as inpatient set-up. The investigators hypothesise~     that outpatient set up using an auto-titrating NIV device will be more cost effective than~     nurse-led inpatient titration and set-up.~      The investigators will undertake a multi-national, multi-centre randomised controlled trial.~      Subjects will be randomised to receiving usual inpatient set-up, which will include~     nurse-led initiation of NIV or outpatient set-up with an automated NIV device. Subjects will~     be stratified according to trial site, gender and previous use of NIV or continuous positive~     airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required.~     Cost effectiveness will be evaluated using standard treatment costs and health service~     utilisation and using health related quality of life measures (SRI and EQ5D). Change in the~     severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance~     (ANCOVA) adjusting for the baseline measurements between the two arms of patients.~   "
54564|NCT02342886|"~     The purpose of this study is to assess the efficacy, safety and tolerability of a~     combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and~     treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB~     compared to standard HRZE treatment.~      This study will also assess the efficacy, safety and tolerability of a combination of~     moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects~     with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin,~     PA-824, and pyrazinamide treatments in DS-TB subjects.~   "
54565|NCT02342873|"~     The investigators compared the postoperative analgesia of nerve stimulator-guided and~     ultrasound-guided interscalene block after shoulder surgery.~   "
54566|NCT02342860|"~     The investigators will conduct a cluster-randomized trial to assess the impact of a~     school-based water, sanitation and hygiene program on health and educational outcomes of~     school children in Saravane Province, Laos. The intervention will include an improved water~     supply (borehole), a sanitation block that includes three pour-flush latrines with rainwater~     harvesting to be used for flushing and a urinal, and sinks for handwashing with soap. The~     school will also receive a facility for group handwashing (large pipe where many children~     can wash hands at once. United Nations International Children's Emergency Fund (UNICEF) will~     additionally provide behavior change education. Our key outcome of interest is pupil~     absence, which will be measured longitudinally using roll-call on days of schools visits.~     Secondary outcomes include self-reported absence, diarrhea and respiratory infection of a~     random selection of students. The investigators will also monitor the fidelity of the~     intervention and assess school conditions and pupil sanitation and handwashing behaviors~     using structured observation.~   "
54567|NCT02342847|"~     This is an observational, post-authorization, prospective follow-up, multi-centre, national~     study designed to describe the spectrum of health-related quality of life in patients with~     metastatic pancreatic cancer previously untreated with chemotherapy This study is designed~     to observe patients treated in routine clinical practice, without the exclusion limitations~     of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the~     decision to treat patients will be performed prior to the decision to include the patient in~     the study.~      Given the observational nature of the study, follow-up of patients will be performed~     according to standard clinical practice of each site.~   "
54570|NCT02342808|"~     This study will examine the effects of lifestyle intervention on fitness, dietary habits,~     and body weight in patients with resistant hypertension (RH). Patients will be randomized to~     either a 4-month adjunctive lifestyle intervention designed to lower BP that will be~     delivered in a center-based CR program (C-LIFE), or to standardized education and physician~     advice (SEPA) designed to promote the same healthy behaviors and reflecting the current~     highest possible standard of care for promoting a healthy lifestyle in RH.~   "
54571|NCT02342795|"~     The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the~     influence of novel tobacco products on biomarkers of toxicant exposure and disease risk,~     reports of adverse events, and concurrent use of other tobacco products. In this case, the~     novel products are one type of electronic cigarette and an imitation cigarette or cigarette~     substitute.~   "
54572|NCT02342782|"~     This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when~     given together with standard combination chemotherapy before a stem cell transplant in~     treating patients with mature T-cell non-Hodgkin lymphoma. Radioactive substances linked to~     monoclonal antibodies, such as yttrium Y 90 basiliximab, can bind to cancer cells and give~     off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as~     carmustine, cytarabine, etoposide, and melphalan (BEAM), work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving yttrium Y 90 basiliximab and chemotherapy before a stem~     cell transplant may help kill any cancer cells that are in the body and help make room in~     the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells that~     were collected from the patient's blood and stored before treatment are later returned to~     the patient to replace the blood-forming cells that were destroyed.~   "
54573|NCT02342769|"~     TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose~     combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring~     measures in the practice of HIV care in Germany. The primary study objective is a~     descriptive report of the incidence of therapeutic monitoring measures in HIV-infected~     patients under TRIUMEQ therapy in everyday routine practice in Germany. The study is~     designed to enroll approximately 400 patients. There are no protocol-mandated visits or~     procedures associated with the study. Each patient is expected to participate for a maximum~     of 3 years or until premature discontinuation (i.e., discontinuation of TRIUMEQ, due to~     death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the~     ViiV Healthcare group of companies.~   "
54574|NCT02342756|"~     The use of positive end-expiratory pressure (PEEP) has been shown to prevent the cycling~     end-expiratory collapse during mechanical ventilation and to maintain alveolar recruitment,~     keeping lung portions open, increasing the resting end-expiratory volume. On the other hand~     PEEP may also overdistend the already open lung, increasing stress and strain.~      Theoretically high frequency oscillatory ventilation (HFOV) could be considered an ideal~     strategy in patients with ARDS for the small tidal volumes, but the expected benefits have~     not been shown yet.~      PEEP and HFOV should be tailored on individual physiology. Assuming that the esophageal~     pressure is a good estimation of pleural pressure, transpulmonary pressure can be estimated~     by the difference between airway pressure and esophageal pressure (PL= Paw - Pes). A PL of 0~     cmH2O at end-expiration should keep the airways open (even if distal zones are not certainly~     recruited) and a PL of 15 cmH2O should produce an overall increase of lung recruitment.~      The investigators want to determine whether the prevention of atelectrauma by setting PEEP~     and mPaw to obtain 0 cmH2O of transpulmonary pressure at end expiratory volume is less~     injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a~     threshold of 15 cmH2O of transpulmonary pressure.~      The comparison between conventional ventilation with tidal volume of 6 ml/Kg and HFOV~     enables us to understand the role of different tidal volumes on preventing atelectrauma and~     inducing lung recruitment.~      The use of non-invasive bedside techniques such as lung ultrasound, electrical impedance~     tomography, and transthoracic echocardiography are becoming necessary in ICU and may allow~     us to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw~     settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV.~   "
54575|NCT02342743|"~     The purpose of this pilot study is to assess the efficacy of the Cefaly device in the~     treatment of chronic migraine prior to implement a control trial where the size and final~     protocol will be specified thanks to the outcomes of this pilot trial.~   "
54576|NCT02342730|"~     This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or~     patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see~     a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or~     obesity is one of the most common contributors to (causes of) endometrial cancer. Over~     two-thirds of women who have survived endometrial cancer are obese. Complications of~     obesity, such as heart disease are often more dangerous than the cancer itself. A weight~     loss of even 5-10% of excess body weight is associated with improved health. Often, meeting~     with a doctor or person who is an expert in weight loss (bariatric specialist) is the best~     way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical~     hyperplasia who go see a weight loss specialist recommended by their doctor may be able to~     achieve a healthier body weight.~   "
54577|NCT02342717|"~     To investigate whether and to what extent co-administration of multiple doses of~     itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects~   "
54578|NCT02342704|"~     The primary objective of this study is to assess the effect of natalizumab compared to~     fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to~     persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this~     study population are to assess the effect of natalizumab compared to fingolimod on: magnetic~     resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as~     measured by the number of new T1-Gd+ lesions; various other MRI measures of disease~     activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The~     change in information processing speed as measured by the Symbol Digit Modalities Test~     (SDMT).~   "
54590|NCT02342548|"~     This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following~     study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and~     tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from~     baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)~     assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of~     treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of~     treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding~     A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects~     will be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7~     days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to~     260 subjects may take part in this open label extension~   "
54579|NCT02342691|"~     The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME,~     topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed~     by the incidence of adverse events, including mucosal inflammation and irritancy and~     findings from safety labs. Subjects will be monitored for development of periodontitis, and~     oral flora will be analyzed to detect an increase in opportunistic organisms.~      The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring~     changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP)~     and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).~      The study comprises three groups in a randomized, placebo-controlled double-blind clinical~     trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group~     will each include 50 subjects. The no-rinse control group will consist of 25 subjects.~     Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or~     placebo) to be applied once daily after morning teeth brushing. Safety parameters will be~     assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will~     be assessed before and after 14 and 28 days of treatment.~   "
54580|NCT02342678|"~     The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy~     program versus physical conditionin control program for treatment of urinary incontinence in~     ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria~     for frequency of incontinence episodes, are not using other clinical treatments for~     incontinence, and meet minimum physical mobility requirements and other eligibility criteria~     will be recruited from the general San Francisco Bay Area.~   "
54581|NCT02342665|"~     The primary objective of this study is to assess the safety profile of copanlisib at the~     recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese~     patients will be determined in the dose escalation/safety evaluation part~   "
54582|NCT02342652|"~     This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2~     multiple dose cohorts of healthy elderly subjects.~      The purpose of the study is to determine the safety, tolerability and pharmacokinetics of~     ASLAN003 in healthy elderly male and female subjects.~   "
54583|NCT02342639|"~     The purpose of this study is to determine if Rifaximin decreases serum and urine levels of~     bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to~     evaluate changes in the bacterial content of the stool from these individuals.~   "
54584|NCT02342626|"~     The overall goal of this project is to test an interactive, multi-media decision aid in the~     form of an electronic clinical decision dashboard designed to improve the quality of~     clinical decision making for initial treatment of patients with newly diagnosed, low or~     intermediate risk prostate cancer.~   "
54585|NCT02342613|"~     This Phase 1 clinical study is designed to examine the safety and feasibility of using~     anti-CD3/CD28 activated marrow infiltrating lymphocytes (MILs) as treatment of relapse after~     allogeneic hematopoietic cell transplantation (alloHCT) for patients with hematologic~     malignancies with bone marrow involvement of their relapsed disease. These MILs will be~     derived from the bone marrow of the relapsed patient who had previously received~     post-transplantation cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis~     (PTCy-MILs). A bone marrow aspiration will be performed on the patient to collect ~200ml of~     marrow for ex vivo expansion. During this expansion process, T cells will be activated and~     expanded by co-stimulation with anti-CD3/anti-CD28 monoclonal antibodies covalently attached~     to super-paramagnetic microbeads. Patients will be treated with salvage therapy while this~     ex vivo expansion is ongoing. After the simultaneous salvage therapy and ex vivo expansion,~     the activated PTCy-MILs will be reinfused. Patients will be monitored with the primary~     objective being the feasibility of expanding to targeted dose levels activated PTCy-MILs~     that do not cause grade III-IV acute GVHD within the first 90 days after PTCy-MIL infusion.~   "
54586|NCT02342600|"~     This study evaluates the combination of trametinib and pazopanib in patients with advanced~     gastrointestinal stromal tumors (GIST).~   "
54587|NCT02342587|"~     Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved~     for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or~     amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and~     protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of~     tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium,~     germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.~      Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both~     ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor~     may provide improved therapeutic benefit compared with inhibitors that target only one or~     the other receptor.~      Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients~     with HER2-positive refractory cancer.~   "
54588|NCT02342574|"~     Double blind, placebo controlled, parallel group ascending dose study evaluating single and~     multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the~     objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and~     potent antifungal agent for the treatment of invasive aspergillosis, will be delivered~     intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real~     time. Safety and tolerability of those schedules will also be assessed.~   "
54589|NCT02342561|"~     This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on~     the quantity of skin bacteria, which is a known factor in the development of surgical site~     infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery~     (TKA) are recruited for participation in an intervention performed at the orthopedic ward of~     Odense University Hospital, Denmark.~      Right or left patient knee is randomized to receive draping with IIAD, while the other knee~     is not draped. Local standard preoperative procedure for knee surgery is then simulated.~      After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and~     samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are~     then compared using nonparametric statistics.~   "
54591|NCT02342535|"~     The goal of this study is to pilot-test a culturally-salient physical activity intervention,~     using a randomized design, among under served, overweight/obese South Asian women at high~     risk for developing Diabetes.~   "
54593|NCT02342509|"~     The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve~     volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In~     contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations.~     In this study the investigators compared feasibility, costs and recovery times after~     anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and~     spontaneously breathing patients.~   "
54594|NCT02342496|"~     The purpose of this study is to evaluate the ability of a blend of berries and probiotics in~     reducing low-grade inflammation and intestinal permeability in the elderly. The intervention~     period is one month. Blood and fecal samples will be collected for analysis at baseline and~     at the end of the intervention with the aim to analyse possible changes in different~     parameters at the two timepoints. The participants will also be asked to keep a study diary~     throughout the study period for the documentation of their intestinal health and as a means~     for checking compliance.~   "
54595|NCT02342483|"~     This randomized, double-blind, adaptive design study aims to prove that the~     Methylsulfonylmethane study product improves nasal breathing and stuffy nose symptoms~     after exposure to environmental allergens. Endpoints include percent change in Peak Nasal~     Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in~     response to allergen exposure.~   "
54596|NCT02342470|"~     The purpose of this study is to evaluate the efficacy and safety by comparing prevention of~     recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.~   "
54597|NCT02342457|"~     Children with chronic constipation, suspected of having hirschsprungs disease, who are~     admitted for rectal biopsy will be included in the study. During the procedure,~     electrophysiological reading from the site chosen for biopsy will be done. Correlation~     between electrophysiological data and histopathology will be analyzed.~   "
54598|NCT02342444|"~     The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many~     times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing~     clots in their legs or lungs. There are two standard doses of enoxaparin that are~     recommended by the drug companies. These two doses have never been directly compared in~     trauma, general, and vascular surgery patients. The purposes of this study are:~        1. to compare the development of blood clots in patients receiving 30mg twice daily of~          enoxaparin compared to patients receiving 40mg once daily of enoxaparin.~        2. to determine if there is higher risk of bleeding complications in patients receiving~          30mg twice daily of enoxaparin compared to patients receiving 40mg once daily.~      Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily~     or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of~     blood clots. At the time of discharge (or before, if medically indicated), an ultrasound~     test will be performed to look for blood clots in the patient's legs.~      The investigators will compare incidence of blood clots formed between the 2 groups of~     patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in~     critically ill patients. The investigators will also compare the incidence of bleeding~     complications between the 2 groups.~   "
54599|NCT02342431|"~     The study is a comparison of a patient warming system using a forced-air, non-compressible~     under-body mattress (Möck & Möck, Hamburg, Germany) versus a regular forced-air underbody~     mattress system during pediatric cardiac catheterization in 40 patients.~      The hypothesis is, that the non-compressible mattress provides better warming with less~     incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope~     (°C / time). The study is prospective, randomized, controlled and single-blinded.~      Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment~     of therapeutic hypothermia.~   "
54600|NCT02342418|"~     This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal~     body weight- matched non-obese subjects. Qualifying subjects who have completed an informed~     consent will receive a single intravenous dose of tedizolid with the collection of 11 blood~     samples over 72 hours post dose.~   "
54601|NCT02342405|"~     The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is~     much higher than previously assumed, with approximately 10 % of patients undergoing~     non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study~     furthermore showed that patients treated with a high inspiratory oxygen fraction during~     surgery had a higher 1 year mortality compared with patients treated with a low inspiratory~     fraction. This was especially significant among patients undergoing cancer surgery. A~     possible explanation, is that a high oxygen fraction results in oxidative stress and~     endothelial dysfunction.~      With this randomized cross-over study we wish to investigate the effect of a high~     inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The~     primary outcome is the endothelial function assessed by the EndoPat system. Secondary~     outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will~     serve as a measure for the effect of oxygen on the autonomic nervous system.~   "
54602|NCT02342392|"~     The purpose of this study is to evaluate the pterygium vascularity and size before and after~     intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium~     excision surgery.~   "
54603|NCT02342379|"~     Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy~     bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease~     progression.~   "
54604|NCT02342366|"~     The purpose of this study is to determine whether gamma-Hydroxybutyrate (GHB) has prosocial~     and prosexual effects in healthy male participants, and to characterize these putative~     effects via behavioral tests, functional magnetic resonance imaging (fMRI),~     electroencephalography (EEG), and neuroendocrine parameters. The investigators predict that~     GHB in fact has prosocial and prosexual effects which can be neurobiologically characterized~     using the assessed methods. Such effects would be of high interest for the treatment of~     mental disorders which involve impairments of social interaction and sexual function such as~     major depression or autism.~   "
54605|NCT02342353|"~     There are two parts to this study: the goal of the first part of the study is to find the~     best dose of pacritinib when given in combination with erlotinib. The goal of the second~     part of the study is to look at the response rate of pacritinib and erlotinib when given in~     combination.~   "
88175|NCT01903161|"~     The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in~     patients undergoing cardiac valve replacement surgery.~   "
54606|NCT02342340|"~     This is a single site, blinded, randomized, controlled study designed to examine~     phytochemical absorption, metabolism and excretion, as well as vascular health and satiety,~     after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Eligible~     participants will attend 6 in-person clinic visits for comparative testing of the 4 bean~     varieties versus lentils and rice.~   "
54607|NCT02342327|"~     The purpose of this study is to determine if in smokers of menthol cigarettes, switching to~     non-menthol cigarettes prior to a cessation attempt results in greater cessation success~     than attempting to quit without first switching~   "
54608|NCT02342314|"~     The study involves a single dose of LY3143753 or LY3185643, given as an injection into the~     abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The~     study is approximately 12 weeks for each participant, not including screening. Screening is~     required within 28 days prior to the start of the study. This study involves Part A~     (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose~     level.~   "
54609|NCT02342301|"~     We aim to determine if changing a person's workstation from a traditional seated desk to a~     height adjustable standing desk for a period of approximately 3 months is associated with~     alterations in traditional measures of cardiometabolic risk.~   "
54610|NCT02342288|"~     A rare but terrible complication of vision loss has been known to occur after surgery,~     including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is~     one of the reasons for this rare vision loss. It has been shown that the prone position can~     increase the IOP, and that tilting the patient with the head down can also increase IOP. The~     investigators will be measuring IOP before, during, and after a posterior spine surgery to~     see if the investigators can influence the intraocular pressure with elevated head position~     change. Two groups will be studied: one group of patients will receive standard care with~     the head in neutral position, while the other group will have the head slightly elevated 10~     degrees during prone spine surgery.~   "
54611|NCT02342275|"~     The purpose of this study is to compare the efficacy of orally administered propranolol~     versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.~   "
54612|NCT02342262|"~     RATIONALE: The prevalence of migraine is higher in patients with various intestinal~     diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased~     intestinal permeability that allows food particles to pass the gastrointestinal wall.~     Probiotics may be able to improve intestinal barrier function.~      OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and~     severity of migraine attacks by reducing intestinal permeability.~      STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected~     probiotics.~      STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION:~     Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the~     placebo, containing only the carrier material (both provided by Winclove Probiotics).~      MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by~     diaries and validated headache questionnaires will be measured at baseline and after 4, 8,~     and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be~     measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12~     weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed~     from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks).~     Fecal samples will also be used for microbial analysis.~   "
54613|NCT02342249|"~     The primary objective of the study is to evaluate the time to resolution of influenza~     symptoms in adults with acute uncomplicated seasonal influenza A following administration of~     VX-787, with and without concomitant oseltamivir.~   "
54614|NCT02342236|"~     Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old,~     especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still~     remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The~     incidence of such events in patients who underwent big joints arthroplasty can be as high as~     40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood~     flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or~     destroyed. After neuronal damage specific substances, such as S100B protein, glial~     fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the~     blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of~     blood flow will decrease regional cerebral saturation in affected parts of the brain.~      In this project the authors would like to analyze the correlation between the regional~     cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic~     patients scheduled to primary hip arthroplasty.~   "
54615|NCT02342223|"~     The purpose of this study is to test the safety of Voluma and see what effects it has on HIV~     facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively~     impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.~   "
54616|NCT02342210|"~     Recent research has suggested that mindfulness-based interventions for psychosis may be~     effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack~     of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices)~     and could lead to improvements in functioning and quality of life. However these findings~     are based on small studies that largely consist of patients with chronic illness. Little is~     yet known about the use of mindfulness interventions for young people recovering from their~     first episode of psychosis.~      The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC),~     a 12-week facilitated group intervention promoting mindfulness skills and the development of~     emotional and social competencies, is an effective, feasible, and acceptable means of~     treating youth in the early stages of psychotic illnesses. Although the current study is~     hypothesis generating in nature, based on previous investigations of Mindfulness Based~     Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC~     intervention will result in improvements in clinical, cognitive, functional, and health~     service utilization parameters. Additionally, we expect that the MAC intervention will prove~     to be acceptable to participants and a feasible intervention for early psychotic disorders.~   "
55955|NCT02324699|"~     Use of co-induction with corticosteroid therapies may accelerate the remission rate when~     used with vedolizumab. Further, this may lead to higher rates of response and remission at~     week 10 than would be seen with vedolizumab monotherapy.~   "
54617|NCT02342197|"~     Objective: To compare two stimulation protocols, the minidose long protocol and the~     microdose flare protocol designed for low responders undergoing ICSI.~      Design: Randomized prospective study. Setting: University hospital IVF unit. Patients: 60~     poor responder patients coming for IVF center for ICSI. Interventions: Minidose long~     protocol in which half the dose of agonist was administered from the mid luteal phase until~     the day of HCG administration was compared with microdose flare protocol in which half the~     dose of GnRH was administered from the second day of the cycle until the day of HCG~     administration. Both groups received Gn stimulation from the second day of the cycle~     (300-450 IU).~      Main outcome measures: Number of oocytes retrieved.~   "
54618|NCT02342184|"~     This study will carry out to assess the efficacy of GB-0998 (intravenous~     immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome~     based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition,~     to assess the safety of GB-0998.~   "
54619|NCT02342171|"~     This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will~     evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients~     with confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible~     products are available and all efforts will be made to maximize CP availability during the~     study. EVD patients recruited during the period before CP becomes available or for whom no~     compatible CP is available will be given SC and will be followed for study outcomes. Data~     from these SC patients will be the used as comparator in the analysis of the study. The~     primary objective of the study is to assess if CP + SC improves the 14 day survival of~     patients, compared to SC alone.~      The Investigators aim to enroll a total number of 130 - 200 patients who will be treated~     treated with CP assuming equal numbers of patients treated with SC alone. If there would be~     insufficient patients treated with SC, patients treated at the research site prior to study~     start may be included in the comparison group.~      Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres~     (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be~     informed about the study, and will be invited to provide consent at the time of admission~     inside the treatment centre. Only patients for whom ebola infection is confirmed with~     polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility~     to the intervention will be reassessed on regular intervals. If the eligibility criteria are~     not met by 48 hours after inclusion, only SC will be continued.~      In line with the guidance of the World Health Organization (WHO), two units of CP will be~     given. EVD patients will be transfused with ABO-compatible CP using standard procedures.~     Details on the modalities of transfusion can be found in the WHO guidance document and the~     MSF guidelines on blood transfusion. All patients will be under close observation for~     transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours~     after the start of transfusion, a blood sample will be collected for viral load assessment.~     All other aspects of patient management will be according to MSF clinical guidelines. The~     decision to discharge a patient should be taken on clinical grounds, but can be supported by~     the laboratory results. After discharge, the patient will be followed up by the study team~     until day 30.~   "
54620|NCT02342158|"~     PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number~     patients with locally advanced or metastatic cancer for whom identification of molecular~     alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will~     enroll 460 patients in 3 years.~   "
54621|NCT02342145|"~     The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host~     disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia~     major. The objective was to evaluate the effect and safety of basiliximab for acute~     graft-versus-host disease.~   "
54622|NCT02342132|"~     Children with neuromuscular diseases (NMDs) and weak chest muscles suffer frequent chest~     infections, hospital admissions and reduced life expectancy. Physiotherapy is widely used~     but there is limited research data to support choice of therapy. The investigators will~     study the clinical value of the three most commonly used chest physiotherapy devices in~     children with NMD's by measuring lung function tests before and after each of the three~     treatments. This is a pilot study. The best device will be selected for a long term study of~     early physiotherapy intervention in children with NMDs.~      The treatments that have been developed to break the cycle of decreasing lung volume and~     poor secretion clearance, in children with NMDs, are all based on the same logical but~     unproved theory of treatment:~        1. The loss of lung volume is reversed by applying positive pressure to the lungs via a~          face mask - literally reinflating the lungs with pressure. The three devices the~          investigators will test all provide positive pressure assistance during the inspiratory~          phase.~        2. The temporarily increased lung volume then allows higher expiratory flow rates which~          helps to clear secretions. The expiratory phase is assisted by manual chest compression~          or, in one device, helped by application of negative pressure during exhalation.~      All three devices that the investigators wish to compare follow this two-step approach. The~     hypotheses behind our study are:~        1. Treatments combining positive pressure inhalation with assisted coughing during~          exhalation, will produce measurable improvements in lung volume and expiratory cough~          flow rates when tested in children with NMDs.~        2. One of the three devices tested will be superior to the others. This will provide~          research-based justification for a long term study of the value of early intervention~          in children with NMDs.~   "
54623|NCT02342119|"~     Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney~     disease (ESKD). But, the evaluation process for a kidney transplant is lengthy, time~     consuming, and burdensome to the patient. Also, race disparities exist in rates of~     transplant evaluation completion, transplantation, and LDKT. Our previous and ongoing~     NIDDK-funded research indicates that cultural factors (i.e., perceived discrimination in~     health care, religious objection to LDKT), transplant knowledge, and demographic~     characteristics (e.g., age, education, income) independently and significantly predict time~     to complete transplant evaluation. In December 2012 the investigators' transplant center~     implemented a one-day streamlined evaluation process, dubbed Kidney Transplant Fast Track~     (KTFT), but it has not been evaluated for efficacy or cost effectiveness. Thus, the~     investigators propose a quasi-experiment to determine the efficacy and cost-effectiveness of~     the KTFT (n=1030) compared to historical controls (n=1140) who were recruited for the~     investigators' current NIDDK study to increase transplant rates. At the same time, the~     investigators will conduct a randomized controlled trial (RCT) targeting vulnerable patients~     with the educational component of the TALK intervention (Talking About Live Kidney Donation)~     to increase LDKT. For both components of the proposal, the investigators will target~     vulnerable populations because they are most at risk for extended evaluation times and lower~     rates of LDKT. Using CONSORT standards, participants will be randomly assigned to TALK~     (n=515) versus no-TALK (n=515) conditions and undergo two interviews at pre-transplant~     work-up and at completion of transplant evaluation in order to: (1) test whether KTFT and~     TALK will reduce transplant evaluation time, and increase rates of transplant and LDKT in~     members of vulnerable groups; (2) determine whether engaging in a streamlined and~     coordinated-care evaluation experience within the transplant center reduces negative~     perceptions of the healthcare system; and (3) test the cost effectiveness of the KTFT with~     TALK relative to standard practices. The results of this two-pronged approach will help pave~     the way for other transplant centers to implement a fast-track system at their sites,~     improve quality of care by transplanting a larger number of vulnerable patients, and may~     help address stark race/ethnic disparities in rates of LDKT.~   "
54624|NCT02342106|"~     The investigators will study the immune cell subpopulations in follicular fluid of patients~     undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will~     corelate the presence of immature myeloid cells to the ovarian stimulation response as~     indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level~     developed on the day of human chorionic gonadotropin (hCG) administration.~   "
54625|NCT02342093|"~     Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP);~     however, when associated with ethinylestradiol (EE), this effect does not seem to occur.~     This study has the objective to assess possible differences in BP associated with the use of~     COCs containing DRSP with different doses of ethinylestradiol.~      Materials and methods: This open-label parallel-group randomized clinical trial involved~     women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22).~     Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring~     (ABPM) at the beginning of the trial and six months after drug therapy.~   "
54626|NCT02342080|"~     Patients with incomplete spinal cord injury~   "
54628|NCT02342054|"~     High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more~     advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and~     in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in~     terms of biochemical control, patient survival and toxicity, but there are still certain~     limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical~     trial.~      The primary endpoint of this study is to evaluate the safety, tolerance and impact on~     quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with~     low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in~     terms of cancer control and satisfaction of the patients undergoing the experimental~     treatment.~      Forty nine patients will be recruited for the experimental procedure Quality of Life,~     tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized~     procedures and scales. Patient satisfaction with the procedure will be appraised using~     five-category predetermined Likert scale questions.~      Two different types of intermediate analyses will be performed: with 15 and 30 recruited~     patients.~      The experimental treatment tested in this study is very innovative. Since prostate cancer is~     the most frequent cancer in men in Spain, this trial results are very likely to have a major~     impact on the standard therapy for prostate cancer in our National Health Service, allowing~     for a higher number of Hospitals within our country and other countries starting protocols~     of HDR BT 19Gy in single fraction.~   "
54629|NCT02342041|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     SUVN-G3031 in healthy male subjects following single or multiple ascending doses.~   "
54630|NCT02342028|"~     To compare the number and function of regular T cell of patients with obstructive sleep~     apnea (OSA) versus that of age-, gender- and BMI (body mass index)-matched controls~   "
54631|NCT02342015|"~     Background: Circulating osteoprogenitors and RANKL expression in immune cells have been~     implicated in the pathogenesis of osteoporosis and vascular calcification. The role played~     by statin therapy in the bone-vascular axis is unknown.~      Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be~     treated with Atorvastatin 40 mg/day for three months. Blood samples will be collected at~     baseline and at the end of the treatment. Gene expression analysis will be performed to~     assess modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow~     cytometry analysis will be used to study changes in the levels of circulating~     osteoprogenitor cells.~   "
54632|NCT02342002|"~     The purpose of the proposed study is to compare - in a randomized, placebo-controlled,~     double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used~     alone for missed abortion.~   "
54633|NCT02341989|"~     One course of adjuvant carboplatin AUC7 is considered internationally to be a standard~     treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is~     based on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant~     radiotherapy. This study was done without registering data on possible risk factor for~     relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %.~     Data from a prospective, risk-adapted Spanish study showed that patients without risk~     factors had a very low risk of relapse, even without adjuvant treatment. This result is also~     confirmed by a recent analysis of SWENOTECA VII data, showing that this group of patients~     has a risk of relapse of less than 5 % without adjuvant treatment.~      Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients~     with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one~     course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %,~     indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant~     chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should~     be explored in this patient group. The results from SWENOTECA III/VI studies with one course~     of cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low~     rate of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate~     following one course of adjuvant BEP is expected to be very low, close to 1 %.~      The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse~     rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if~     there is a difference in health related quality of life as well as acute and long-term~     toxicities from treatment.~   "
54634|NCT02341976|"~     To study which position on the whole body vibrator machine would stimulate the pelvic floor~     muscles.~   "
54635|NCT02341963|"~     The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain~     after amputation surgery. The objective of the proposed research is to conclusively~     determine if oral ketamine is a safe alternative analgesic to opioid for acute pain in~     subjects undergoing elective amputation of the lower extremity. All participants will~     receive oral ketamine.~   "
54636|NCT02341950|"~     This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to~     enhance self-management skills, self-reported health behaviors, and quality of life among~     adolescents and young adults with spinal cord injury and disease (SCI/D). SCI HARD was~     designed by the project PI, Dr. Meade, in collaboration with the UM3D (University of~     Michigan three dimensional) Lab between 2010 and 2013 with funding from a NIDRR (National~     Institute on Disability and Rehabilitation Research) Field Initiated Development Grant to~     assist persons with SCI develop and apply the necessary skills to keep their bodies healthy~     while managing the many aspects of SCI care. The study makes a unique contribution to~     rehabilitation by emphasizing the concepts of personal responsibility and control over one's~     health and life as a whole. By selecting an innovative approach for program implementation,~     we also attempt to address the high cost of care delivery and lack of health care access to~     underserved populations with SCI/D living across the United States (US).~      H1: SCI Hard participants will show greater improvements in problem solving skills, healthy~     attitudes about disability, and SCI Self-efficacy than will control group members; these~     improvements will be sustained over time within and between groups.~      H2: SCI Hard participants will endorse more positive health behaviors than control group~     members; these improvements will be sustained over time within and between groups.~      H3: SCI Hard participants will have higher levels of QOL than control group members; these~     differences will be sustained over time within and between groups.~      H4: Among SCI Hard participants, dosage of game play will be related to degree of change in~     self-management skills, health behaviors and QOL.~   "
54637|NCT02341937|"~     Patients with cancer have a high risk of deep vein thrombosis which often develops in the~     veins of the lower limbs. The initial evaluation of clinically suspected deep vein~     thrombosis includes the estimation of the clinical probability by calculating risk scores~     such as the Wells score and the measurement of the D-dimer. However, the usefulness and~     accuracy of the clinical scores and d-dimer test are lower in patients with cancer who often~     undergo unnecessary (serial) ultrasonography.~      The aim of the current study is to analyze variables that predict the presence of thrombosis~     and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer~     will be evaluated with the goal of improving the sensibility and specificity of the test.~   "
54638|NCT02341924|"~     The objective of this research project is to investigate the ability to affect~     cardiovascular disease (CVD) risk factors through a novel, easily implemented functional~     food-based approach. The goal of the proposed project is to evaluate the effect of a range~     of proprietary products specifically formulated to deliver convenient pre-packaged~     condition-specific foods to positively impact blood cholesterol levels in statin intolerant~     and/or statin unwilling participants. The specific aim of this project is to evaluate the~     changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,~     insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen~     using healthy tasty foods which are self-selected by a statin intolerant patient group.~   "
54639|NCT02341911|"~     Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast~     Cancer (TNBC)~   "
54640|NCT02341898|"~     Background: Physical restraints as bedrails and belts are still regularly applied in German~     nursing homes despite clear evidence showing their lack of effectiveness and safety. In a~     cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent~     intervention has been shown with a significant reduction in physical restraints use without~     adverse events. The present study aims to apply different versions of the original~     intervention in nursing home residents in four different regions throughout Germany in order~     to evaluate the effectiveness of the programme.~      Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention~     groups ((1) updated original programme and (2) brief version of the updated programme) with~     a control group (3) receiving printed study materials (optimized usual care). Intervention~     (1) consists of an information programme for all nurses, additional training and structured~     support for nominated key nurses, and provision of printed study material and other~     supportive material. For intervention (2) nurses' training is only optional carried out~     facultatively by key nurses who have received an additional train-the-trainer module. The~     control group (3) receives printed study material only. Overall, 120 nursing homes including~     approximately 10800 residents will be recruited, randomized to one of the three groups and~     followed up for 12 months. The primary outcome is defined as proportion of residents with at~     least one physical restraint at 12 months. Physical restraint use will be assessed by direct~     observation. Secondary outcomes are residents` quality of life as well as safety parameters~     as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.~   "
54641|NCT02341885|"~     A prospective international, multi-centre, prevalence study on the epidemiology of the use~     of renal replacement therapy for ICU patients who have acute kidney injury and chronic end~     stage kidney disease.~   "
54642|NCT02341872|"~     The purpose of this study is to determine whether Fluoride varnish + calcium (Clinpro White~     Varnish) and polipeptide solution (Curodont Repair) are effective in the treatment of~     remineralization therapy. The investigators will diagnose their alone or in combination~     effects on white spot lesions. Aesthetics (tooth-colored), remineralization, microbiological~     effects will be evaluated separately. Spectrophotometer (Vita Easy Shade) , Quantitative~     Light Fluorescence (QLF), Diagnodent(Cavo Diagnodent) and culture methods in microbiology~     laboratories are used for aesthetic, remineralization and microbiological assessments. The~     measurements will be made baseline, 6 weeks, 3 months and 6 months later after the~     applications and recorded.~   "
54643|NCT02341859|"~     Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and~     DAILIES TOTAL1®~   "
54644|NCT02341846|"~     This interview and focus group study will explore patient, caregiver, and health~     professional opinions about the potential roles of digital technology to support effective~     cancer pain management. The views, opinions, and ideas expressed in this study will be used~     to design and develop a digital intervention which is likely to take the form of a~     measurement (pain and analgesic use) guided medication management intervention to improve~     cancer pain management in the community.~   "
54645|NCT02341833|"~     The aim of the investigators study is to investigate the effects of anaesthetic~     preconditioning with sevoflurane during organs harvesting in brain dead donors. More~     particularly, the investigators will investigate whether sevoflurane preconditioning~     protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged~     period of cold ischaemia and whether this protection translates in a better clinical~     functional recovery of these allografts.~   "
54646|NCT02341820|"~     This project which is fully funded by the European Union FP7 Program is designed to pull~     together all the information we obtain from scans and x-rays to design a personalised 3-D~     digital model of each patient, their anatomy and disease. We can then use this as follows:~     as (i) an aid to surgical planning to enable objective clinical decision making (ii) a~     decision support tool to communicate the available treatment options to the patient and~     facilitate shared decision making and provision of personalised care and (iii) to enable~     standardised objective evaluation of the aesthetic outcome of the treatment procedures. This~     study aims to demonstrate the ability of the Virtual Physiological Human concept to empower~     breast cancer patients and assess the impact on their care and quality of life.~   "
54647|NCT02341807|"~     This clinical study evaluates the safety and tolerability of AAV2-hCHM in subjects with~     Choroideremia gene mutations. Two dose groups will be evaluated.~   "
54648|NCT02341794|"~     The purpose of this study is to investigate the effects of rosuvastatin treatment on degree~     of intracranial arterial stenosis.~   "
54649|NCT02341781|"~     The objective of this study is to determine the effectiveness of lenalidomide in subjects~     with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL~     subjects who require treatment after receiving ibrutinib therapy are considered a population~     with high unmet medical need. It is therefore of benefit to have data on the outcomes of~     treatment options available in this patient population.~      An observational study design was chosen to collect the clinical data already existing or~     being collected for MCL subjects being treated with lenalidomide.~      MCL subjects who received lenalidomide either as monotherapy or as combination treatment~     after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant~     to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next~     subsequent treatment after ibrutinib.~   "
54670|NCT02341508|"~     The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in~     healthy volunteers. Additional endpoints include characterization of the pharmacokinetic~     (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in~     healthy volunteers.~   "
54650|NCT02341768|"~     The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve~     life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in~     terms of techniques and medical devices, based on the patient's condition.~      It is extremely important in the clinical practice to identify which patients' subgroup~     benefits the most from the ICD therapy, which comorbidity has a major impact on the~     patients' prognosis, or which pre-intra-post procedural behaviors provoke less~     complications, and affect the patient's outcome (including prolonged or unwanted~     hospitalizations).~   "
54651|NCT02341755|"~     This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in~     predicting the need for surgery in patients with Crohn's disease and intestinal lesions with~     obstructive symptoms.~      Patients with known Crohn's disease which were scheduled to perform abdominal CT for~     obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome~     of surgery. DE-CT parameters were then compared between patients who underwent surgery and~     those who did not.~   "
54652|NCT02341742|"~     This study is an observational study. The purpose of this study is to assess the~     relationship between bone health and daily physical activity in children and adolescents~     with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication~     in pediatric IBD. Physical activity is an important determinant of health throughout the~     whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important~     health benefits. Based on available evidence, the investigators hypothesize that daily~     moderate-to-vigorous physical activity could improve bone health (ie bone mineral density)~     in children and adolescents with IBD.~   "
54653|NCT02341729|"~     The first aim of the study is to prove that after starting the therapy with crushed tablets,~     the platelet inhibition will be as expected after starting therapy with intact tablets.~     Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from~     baseline platelet aggregation of >10% 4 hours after last maintenance dose. So the~     investigators expect that after 3 days of treatment, all of our patients will have a closing~     time of more than 106seconds.~      The investigators will observe two different clinical conditions of Acute Coronary Syndrome.~     First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients~     after cardiac arrest.~      Both are clinical situations in which crushed tablets are needed to give. The second~     objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active~     metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg~     start-dose. Determination of plasma concentrations is done after protein precipitation, by~     using liquid chromatography with mass spectrometry detection. Measurements will be~     determined before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h~     this will be a crushed tablet and 4 hours after the first intake at day 4 of therapy, this~     will be a non crushed tablet.~   "
54654|NCT02341716|"~     The purpose of this randomized clinical trial is to determine and compare the clinical and~     cost effectiveness of three methods for exercise therapy as treatment for patients with~     intermittent claudication. The methods tested are a hospital-based (SET) and a home-based~     (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are~     followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking~     with Nordic Poles (NP) at least three times per week and this basic treatment, including~     best medical treatment, is used in all three treatment groups. In addition to this basic~     treatment, the SET group patients during the first six months participate in group-based~     exercise therapy in the hospital for 50 minutes three times weekly, supervised by a~     physiotherapist. The HET group patients perform the same exercise in their home 50 minutes~     three times weekly during six months receiving feedback from a physiotherapist by a phone~     call every 14th day. The SET and HET group patients are recommended to continue the 50~     minutes three times weekly exercise therapy in their homes without supervision during the~     last six months. Primary outcome is change from baseline to 12 months in walking distance~     during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from~     baseline to 12 months in health-related quality of life (HRQoL) using the SF36~     questionnaire. Secondary outcomes include fulfillment of patient-specified goals with~     treatment (PSFS), change in health-related quality-of-life (HRQoL) with a disease-specific~     instrument (VascuQoL), walking impairment as measured by the Walking Impairment~     Questionnaire, physical activity (accelerometer) and compliance with physical exercise~     therapy (patient diary).~   "
54655|NCT02341703|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age.~     Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS.~     The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American~     College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer~     metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone.~     Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be~     associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may~     improve this condition. In this study we will compare the effect of combined~     letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in~     CC-resistant PCOS women~   "
54667|NCT02341547|"~     This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex~     who are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following~     recruitment, a baseline data collection of full routine laboratory test before switch to~     Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary~     endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse~     drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and~     Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate.~     Changes in continuous variables over time were evaluated using repeated-measures analysis of~     variance. Patients with iron-deficiency (ferritin <100 ng/ml or transferrin saturation <20%)~     will be analysed separately~   "
54668|NCT02341534|"~     The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the~     consequent treatment after detected arrhythmias in patients after acute myocardial~     infarction with preserved cardiac function, but other risk factors, decreases the risk of~     major adverse cardiac events.~   "
54669|NCT02341521|"~     An open label study in 9 male and 9 female healthy subjects to determine the~     pharmacokinetics of parent compound and metabolite after eight days of dosing.~   "
54656|NCT02341690|"~     Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with~     T2D experiences reduced quality of life and have a lower physical activity level. Physical~     activity is well documented treatment to the patient group. The effect of physical activity~     is shown to reduce co-morbidity, and better functional level and quality of life.~      Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking~     in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk~     the patient can to IWT independently and when used, the app has, as an exercise tool, the~     potential to better the individual functional level and to measure the physical activity~     level with the integrated personalised walking test.~      Motivation for change of habits and lifestyle is subjectively determined by the individual,~     his or hers individual resources and environment. It is important to get insight in these~     individual challenges in order to be better structure possible help.~      The combination of an exercise log, a measure of physical activity fromInterWalk and insight~     in motivational aspects on an individual level, is essential for successful individualised~     training.~      The primary objective of the study is to investigate if the InterWalk app is more effective~     in increasing the physical activity level compared to a standard care offer in a sample of~     newly T2D diabetes patients across 52 weeks.~      Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss,~     improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and~     reduce the use of diabetes medication.~      The study is designed to test the hypothesis that replacing a standard exercise program in~     the normal municipal standard care with the Interval Walking Training delivered by the IW~     app with and without a motivational support program, can increase the long-term physical~     activity level in patients with T2D for a period of 52 weeks.~      From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion~     centres in the municipality, will be offered to participate in the study. In total 513~     patients with T2D from different municipalities in Denmark will be included and randomly~     allocated into three groups. One group will receive standard care and the two other groups~     will do IWT with the InterWalk app. All three groups are followed by the promotion centre~     for 8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one~     of the IWT groups will receive motivational support up to 52 weeks.~      All patients, no mater group allocation, will be tested and fulfill questionnaires, three~     times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The~     interventions take place at the promotion centres in the municipalities two times a week and~     the patient will be encouraged train by them selves one time a week.~   "
54657|NCT02341677|"~     The purpose of this study is to determine how well SmartTarget guided prostate biopsies~     perform, compared with our current standard of visually directed biopsies in the detection~     of prostate cancer.~      The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease.~     Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the~     disease location. Transperineal mapping biopsies overcome this by systematically samples the~     entire gland but are very intensive and time consuming to perform.~      An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy~     can be used to inform doctors about the location of the disease. This is a difficult~     procedure to perform as it requires the surgeon to mentally translate the location of~     disease on MRI image to the live ultrasound seen in theatre.~      SmartTarget may help this procedure by providing guidance to the location of the disease by~     fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to~     biopsy.~      This trial will compare the outcomes of visually directed biopsies with those directed by~     SmartTarget~   "
54658|NCT02341664|"~     The purpose of the Patient and Provider Assessment of Lipid Management Registry (PALM) is to~     gain a better understanding of physicians' cholesterol medication prescribing practices,~     patient and physician attitudes and beliefs related to cholesterol management, and current~     utilization of cholesterol-lowering therapies given the new ACC/AHA guideline~     recommendations. The PALM Registry hopes to allow for the design of ways to improve~     cholesterol management and decrease the burden of cardiovascular disease (CVD) in the US.~   "
54659|NCT02341651|"~     High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD).~     In rural South Asia, hypertension remains to be a significant public health issue with~     sub-optimal rates of case finding and management. A trial to investigate integrated primary~     care strategies to control hypertension is planned. Packaged interventions for the planned~     full-scale study are varying combinations of 1) home health education (HHE) by trained~     community health workers (CHW), 2) trained government primary health centre mid-level~     providers (MLP) led care and 3) trained private practitioners. The goal of the full-scale~     study is to test which combination of the above interventions is the most effective in~     lowering blood pressure among adults with hypertension in rural communities. In addition,~     the full-scale study aims to quantify the incremental cost- effectiveness of each approach~     in terms of cost per projected cardiovascular disease (CVD) disability adjusted life-years~     (DALYs) averted.~   "
54660|NCT02341638|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.~   "
54661|NCT02341625|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,~     immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and~     in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer,~     ovarian cancer, pancreatic cancer and gastric cancer.~   "
54662|NCT02341612|"~     Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water~     immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at~     10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive~     recovery (control group). The single exposure groups performed cold water immersion~     immediately after exercise-induced muscle damage (EIMD) for 20 minutes. The multiple~     exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD~     (once a day) for 20 minutes. The WBC group remained in the cabin immediately after EIMD for~     3 min. The control group was not exposed to treatment after the EIMD protocol. The subjects~     were asked to visit the laboratory on seven occasions. The first visit was the~     familiarization of the subjects with experimental procedures and their anthropometric~     assessment. One week after familiarization, on visit two, volunteers performed the~     exercise-induced muscle damage (EIMD) protocol and they were allocated to one of~     experimental groups. Indirect markers of muscle damage and inflammatory responses were~     evaluated at baseline (pre), immediately post, 24h, 48h, 72h, 96h, and 168h following the~     EIMD protocol by measuring anterior thigh muscle swelling, isometric knee extensors peak~     torque, knee extensors muscle soreness, countermovement vertical jump and blood sample~     analyzes.~   "
54663|NCT02341599|"~     The purpose of this study is to characterize the effect of renal function on the plasma,~     urine, and dialysate pharmacokinetic profile of CB-238,618 in humans. The study will also~     assess the safety profile and tolerability of CB-238,618 in subjects with varying degrees of~     renal impairment and in healthy subjects.~   "
54664|NCT02341586|"~     The purpose of this research is to determine if cooking with an iron ingot called the Lucky~     Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah~     Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over~     a 12-month period will be as efficacious at increasing hemoglobin concentration as iron~     supplements (18 mg elemental iron) and will be more efficacious than the control.~   "
54671|NCT02341495|"~     The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia~     will go into complete remission (meaning the leukemia is completely gone), and to find out~     how long it stays away. The drugs used in this project are FDA approved and commercially~     available.~   "
54672|NCT02341482|"~     The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF~     04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.~   "
54673|NCT02341469|"~     In 2010, one in six children in Burkina Faso died before the age of five, mainly due to lack~     of access to quality health care services. Most of these deaths could have been avoided~     through cost-effective interventions. Ensuring that sick children receive adequate care in a~     country where 80% of the population lives in rural areas requires improved accessibility and~     high quality primary health care services. The Integrated Management of Childhood Illnesses~     strategy (IMCI) was developed by the World Health Organization (WHO) and the United Nations~     Children's Fund (UNICEF) in the 1990s and is an excellent way to improve the quality of~     country's child health services. However, in Burkina Faso IMCI suffers from a low level of~     adherence by health workers. According to a recent evaluation by the Ministry of Health~     (MoH), only 8.2% of children had benefited in 2012 from an consultation using IMCI~     guideline. Moreover, an analysis of children's records showed that only 15% of IMCI~     consultations were being correctly delivered and, for instance, only 34% of children with~     pneumonia who needed an antibiotic were prescribed the correct treatment. The obstacles to~     IMCI adoption in Burkina Faso are diverse and include inadequate training methods, shortage~     of material (papers, forms), lack of quality supervision by district executive teams, lack~     of integration between IMCI monitoring tools and the national health information system etc.~      The Integrated eDiagnosis Approach (IeDA) aims to address the poor quality of child health~     services in Burkina Faso by increasing the level of adherence to IMCI guidelines. IeDA is an~     innovative strategy combining information and communication technologies (using the Registre~     Electronique des Consultations [REC], an electronic IMCI patient record designed by Terre~     des hommes, Tdh) and a quality improvement approach. The approach has been piloted over~     three years in two different districts in the north of Burkina Faso, Tougan and Séguénéga.~     This medium scaling-up demonstration project will combine implementation and research~     components with a goal to enable national scaleup.~      Terre des hommes is in charge of the implementation of the project and the London School of~     Hygiene and Tropical Medicine (LSHTM) will coordinate the research component of the study in~     partnership with Centre Muraz.~      The primary hypothesis is that the Integrated eDiagnosis Approach will lead to improved~     adherence to IMCI guidelines and management of childhood illnesses in two regions (with a~     target of 75% of correct diagnoses and prescriptions).~   "
54674|NCT02341456|"~     This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in~     monotherapy and in combination with carboplatin and paclitaxel to Asian patients with~     advanced solid tumours.~   "
54675|NCT02341443|"~     Mandibular fractures represent approximately 50% of the total facial fractures and are~     commonly (more than half) presented in more than one location. A few simple fractures can be~     treated using a conservative approach. More often, however, mandibular fractures require~     stabilization using open reduction and internal fixation.~      Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on~     the load-sharing principle, by which stabilization is accomplished with both fixation~     devices and bone surfaces. On the other hand, more complex fractures with continuity defects~     or comminuted need to be handle using rigid fixation where the device assumes all the forces~     (load-bearing principle). These approaches are well established, whereas the level of~     evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce.~     In fact, which surgical treatment, or combination of treatments, leads to the best outcome~     and the lowest rate of complications in bilateral DMFs is an open question.~      The purpose of this study is to assess the complication rate in patients suffering from~     bilateral DMF treated either using non-rigid fixation on both fracture sides or a~     combination of rigid fixation on one side and non-rigid fixation on the other side.~   "
54676|NCT02341430|"~     This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh~     option in the repair of grade I and II ventral hernias.~   "
54677|NCT02341417|"~     This is a phase 3, 32-week, multicenter, single arm, open-label extension study. All~     enrolled subjects will be administered cinacalcet daily during the treatment period in~     addition to standard of care treatment which can include therapy with Vitamin D sterols,~     calcium supplementation, and phosphate binders.~   "
54678|NCT02341404|"~     The primary aim of the study was to characterize and quantify the histopathological changes~     in the surgical specimens obtained in patients undergoing prostatectomy in addition to~     imaging changes (MRI) following a single injection of Liproca Depot in patients with~     localized prostate cancer.~   "
54679|NCT02341391|"~     The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene~     therapy product that uses allogenic human chondrocytes expressing Transforming Growth~     Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and~     severity of the adverse events, the physical examination findings, and the laboratory test~     results after the intra-articular injection of TissueGene-C.~      And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion,~     functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the~     injection site.~   "
54680|NCT02341378|"~     To assess the efficacy and safety of the intra-articular injection of TissueGene-C in~     patients with degenerative arthritis of the knee~   "
54681|NCT02341365|"~     Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin~     D, ovarian reserve and ovarian response to controlled stimulation in egg donors.~   "
54682|NCT02341352|"~     Analysis different measures preventive effect on carious Lesions incidence and oral~     microecological system change of preschool children~   "
54683|NCT02341339|"~     Prospective Feasibility Study:~      Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during~     their surgical evaluation of infertility. Of note, these patients are already scheduled to~     undergo surgery as part of their standard of care.~   "
54684|NCT02341326|"~     Early changes associated with the development of smoking-induced diseases, e.g., COPD and~     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal~     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells~     necessary for generation of differentiated airway epithelium. Based on our preliminary~     observations on SAE BC cells and FGFR2 signaling, we hypothesized that suppression of FGFR2~     signaling in the SAE BC stem/progenitor cells by cigarette smoking renders these cells less~     potent in generating and maintaining normally differentiated SAE, shifting these cells~     towards a COPD associated phenotype. To test this, SAE basal cells will be isolated from~     cultured cells obtained through bronchoscopic brushings and analyzed through in vitro assays~     for their stem/progenitor capacities.~   "
54707|NCT02341027|"~     This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG)~     contraceptive implant within 5 days of delivery improves implant utilization at 6 months~     postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.~   "
54685|NCT02341313|"~     Low blood sugar levels are common in babies after birth. This may be normal as babies can~     use other sources of energy. However if a baby does not produce these fuels the brain can be~     starved of energy and be damaged. Measurement of these fuels is not done as part of clinical~     practice in the newborn. We aim to see whether at the same time as taking the blood sugar~     level from a heel prick we can measure these fuels in a small drop of blood. At the same~     time as blood needs to be taken for clinical reasons we want to take a drop of blood from 50~     babies to see how good the point of care (POC) meters are compared to the laboratory at~     measuring these fuels. If accurate these POC meters could identifying those at risk from~     brain damage as well as prevent separation of mothers and babies who are establishing breast~     feeding.~   "
54686|NCT02341300|"~     Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the~     first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of~     anemia are variable and depend largely on preexisting iron stores and supplementation.~     Estimates from the World Health Organization report that 35% to 75% of pregnant women in~     developing countries and 18% of women from industrialized countries are anemic. Maternal~     anemia is associated with an increased risk of preterm birth, low birthweight, and small for~     gestational age infants. Many studies have shown improvement in these outcomes with maternal~     iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates~     that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the~     first year of life.~      Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that~     anemic pregnant women are at greater risk of death during the perinatal period and that~     anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal~     deaths per year.~      The need for iron averages close to 1000mg in a typical singleton gestation. This amount~     considerably exceeds the iron stores of most women and will result in iron-deficiency anemia~     unless supplemental iron is taken. One problem with iron supplement use is compliance,~     secondary to adverse effects such as constipation and nausea. Research on the use of cast~     iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has~     been promising. These studies have demonstrated good compliance with no reported adverse~     effects. The aim of our study is to determine if providing anemic women in the first~     trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in~     pregnancy.~      Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.~   "
54687|NCT02341287|"~     The investigators plan to test the effectiveness of warm gel gloves in reducing the time it~     takes individuals to fall asleep (sleep latency). The investigators will have subjects track~     their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called~     an actigraph to measure the degree of the persons' difficulty falling asleep. It must take~     at least 30-minutes to fall asleep 3-days per week to qualify for the study. If a subject~     qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during~     sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. The~     baseline sleep latency data will be compared to the treatment period using a independent~     t-test. The investigators believe that wearing the warm gel gloves will reduce sleep~     latency.~   "
54688|NCT02341274|"~     Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical~     industry to develop poorly water-soluble drugs into effective oral dosage forms. Examples~     include the antifungal drug itraconazole, the HIV protease inhibitor combination,~     lopinavir/ritonavir and the immunosuppressive, tacrolimus. There is potential for~     significant variation in bioavailability of ASD and thus heightened concern regarding the~     therapeutic efficacy as generic versions of these poorly water-soluble compounds become~     approved. The variation in bioavailability is to be expected because of our limited~     understanding of the precise physical chemistry of drug polymer amorphous solid dispersion~     formulations.~   "
54689|NCT02341261|"~     The proposed study will randomize participants with diabetic peripheral neuropathy into two~     groups. One group of participants will receive standard-of-care counseling while the other~     group will undergo supervised exercise and counseling to increase physical activity.~   "
54690|NCT02341248|"~     Exclusive Enteral Nutrition (EEN) is the liquid diet given to children with active Crohn's~     Disease (CD). EEN has previously been shown to induce changes in major bacterial metabolites~     and dominant bacterial species which are more profound in children that clinically improve.~     This study aims to determine whether it is possible to maintain these bacterial changes with~     prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this~     can reduce risk of subsequent relapse for children with CD.~      New technologies will allow measurement of a broad range of bacteria and metabolites, to~     test if the clinical response to EEN and changes in gut inflammation are associated with~     bacterial composition and chemical products; and if maintenance of changes using SEN reduces~     the risk of relapse over a 12 month period.~      The study will aim to recruit all potential Crohn's disease children coming to a tertiary~     paediatric centre for colonoscopy. Once consented, an initial blood, urine and faecal sample~     will be requested along with 8 mucosal biopsies during the routine endoscopy session. If~     diagnosed with CD, and if the clinician prescribes treatment with EEN, an additional blood~     sample will be requested at the end of EEN, and 5 faecal and urine samples spread over 12~     months; as well as some dietary information.~      Samples will be collected from up to 42 children with CD and 42 age- and sex-matched healthy~     volunteers. Initial samples taken from children who were not diagnosed with CD will be~     compared with CD samples to look for potential metabolic disease markers. Characterisation~     of faecal bacteria and metabolites in both faeces and urine; as well as measurement of blood~     inflammatory biomarkers will be performed.~   "
54691|NCT02341235|"~     The purpose of this study is to compare an enhanced intervention that includes narrative and~     game components to a standard intervention that only targets self-monitoring. These~     approaches will be tested among postmenopausal breast cancer survivors who are sedentary and~     overweight.~   "
54692|NCT02341222|"~     The Buckypaper (BP) is an innovative material that has attracted the attention of many~     research groups engaged in the study of its possible applications in various technological~     fields. Our purpose is demonstrate the viability of the application of nanotechnologies to~     the General Surgery in human with thwe use of a new self standing prosthetic device for the~     reconstruction of abdominal wall defects.~   "
54693|NCT02341209|"~     This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell~     Lymphomas.~   "
54694|NCT02341196|"~     This study examines the risk of thrombogenicity of the carotid patches in polyurethane~     compared to carotid patches in polyester including death, any stroke, carotid thrombosis at~     30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.~      This study was run at the University of Roma, La Sapienza and at the University of Poitiers,~     randomisation was done in both enters after approval by the Ethical committee of the~     University of Roma (Record uploaded)~   "
90986|NCT01866462|"~     The purpose of the study is to determine if NM504 will prevent GI side effects that are~     associated with using metformin for the treatment of diabetes.~   "
54695|NCT02341183|"~     The primary objective of this study is to assess tolerability and effect of HS (hypertonic~     saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on~     mucociliary clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis~     (COPD/CB) subjects. The investigators hypothesize that HS delivery via tPAD will be safe and~     and while, and will improve MCC.~   "
54696|NCT02341170|"~     The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic~     cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally~     advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI~     to that of patients without this intervention. In addition, this study aims to investigate~     whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the~     patient's quality of life.~   "
54697|NCT02341157|"~     This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to~     the current disease management COPD discharge protocol subsequent to an admission for COPD~     exacerbation.~   "
54698|NCT02341144|"~     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of~     pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under~     direct visualization prior to closure of the incision for providing post-operative analgesia~     following umbilical hernia repair in children. The current management for reducible~     umbilical hernias is umbilical hernia repair under general anesthesia as an outpatient~     procedure.~      Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study~     inclusion. Eligible patients and their parents/guardians will be approached and, if~     agreeable, consented for the study pre-operatively. Patients will be randomized to receive~     either pre-incisional percutaneous rectus sheath block by the anesthesiologist or~     intra-operative rectus sheath block under direct visualization prior to closure of the skin~     incision by the surgeon. The patient, patient guardians, select research team members, and~     PACU staff will be blinded to the method of analgesic administration.~   "
54699|NCT02341131|"~     The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a~     putative biological marker of the cognitive recovery in schizophrenia following a Cognitive~     Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels~     and the Val66met polymorphism and data from functional and structural neuroimaging will be~     studied.~   "
54700|NCT02341118|"~     BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22%~     germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype,~     including those women who have no family history of breast or ovarian cancer. With the rapid~     advancement of therapeutics targeted this population, this protocol seeks to provide genetic~     BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information~     may help in selection of future treatment options and genetic testing for BRCA1/2 may be~     used to potentially prevent a proportion of cancer for the family members.~      This study will be an opportunity for patient to improve access at genetic and molecular~     testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this~     study will allow to prospectively assess the proportion of patients with BRCA mutation in~     ovarian cancer and describe the type of mutations identified in a large population.~   "
54701|NCT02341105|"~     Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older~     patients with persistent atrial fibrillation (AF).~      Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80~     years with symptomatic AF for the composite outcome of hospitalization for cardiovascular~     cause or emergency department visit for atrial arrhythmia~   "
54702|NCT02341092|"~     Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the~     close friends of people victims of traumatic brain injury.~   "
54703|NCT02341079|"~     The purpose of the study is to evaluate the efficacy of local infiltration of liposomal~     bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early~     postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate~     equivalency of treatment modalities to provide an alternative to the commonly used treatment~     of femoral nerve blockade.~   "
54704|NCT02341066|"~     To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving~     coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score~     (FRS) in rheumatoid arthritis population (RA).~   "
54705|NCT02341053|"~     Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy~     (SMA) are at significant risk for poor bone health as defined by low bone mineral density~     (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at~     least in part, to abnormally low levels of load experienced by the skeleton. A common~     physical approach for increasing bone density is to stimulate the musculoskeletal system by~     increasing the amount and duration of weight-bearing in the lower extremities. For~     non-ambulatory individuals, this takes the form of using an assisted standing device to~     enable the child to spend time in a standing position with some degree of weight placed on~     the lower limbs. Some of these physical interventions demonstrate variable improvement in~     BMD in children with neuromuscular conditions, and some do not. A serious limitation in the~     previous work in this area is a failure to objectively measure the magnitude and duration of~     the loading experienced by the lower extremities. Thus, a lack of change in BMD may be due~     to the extremities experiencing only a fraction of the body weight (due to load-sharing with~     the assistive device) for an inadequate duration of standing time.~      In order to investigate the efficacy of standing treatment for increasing BMD, the~     investigators will develop a simple, portable and inexpensive transducer that will measure~     the magnitude and time course of the load experienced by the lower extremities of~     individuals with SMA who use a stationary assisted standing device. The specific goal of~     this proposed project will be to develop, validate and establish the initial feasibility of~     such a measurement device.~   "
54706|NCT02341040|"~     The goal of the study is to determine accurate blood test levels that can predict whether or~     not subjects are truly allergic to certain foods. In this study, subjects that are~     clinically documented to be wheat-allergic will participate in a double blind oral food~     challenge. Blood will be collected from the subject to evaluate the potential allergenicity~     of proteins introduced into genetically modified crops and evaluate wheat-specific IgE~     antibody reactivity to biotech and conventional wheat varieties.~   "
54708|NCT02341014|"~     This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell~     lymphomas who are treated with carfilzomib, lenalidomide and romidepsin in a 3+3 design. The~     phase IIa portion of the study will involve a dose expansion at the MTD to better~     characterize the efficacy and to inform further disease specific studies.~   "
54709|NCT02341001|"~     The purpose of this study is to determine whether text message support after discharge from~     a bariatric service improves outcomes following bariatric surgery.~   "
54710|NCT02340988|"~     The purpose of this study is to assess the drug interaction potential and time course of the~     effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.~   "
54711|NCT02340975|"~     This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to~     evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and~     immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or~     tremelimumab monotherapy in subjects with metastatic or recurrent gastric or~     gastroesophageal junction adenocarcinoma~   "
54712|NCT02340962|"~     A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy~     and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve~     East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection.~   "
54713|NCT02340949|"~     This trial compares induction treatment with FOLFOX with or without aflibercept in a high~     risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine~     combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of~     pCR.~   "
54714|NCT02340936|"~     The purpose of the Phase I of the study is to evaluate the safety and the maximum-tolerated~     dose (MTD) of the combination R-ESHAP with lenalidomide as salvage therapy for patients with~     relapsed or refractory diffuse large B-cell lymphoma The purpose of the Phase II of the~     study is to evaluate ORR of LR-ESHAP in patients with relapsed or refractory DLBCL~     candidates to HDT and ASCT~   "
54715|NCT02340923|"~     The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on~     healthy children and children with duchenne muscular dystrophy so as to develop a new,~     convenient tool for the office based assessment of children with a wide variety of~     neuromuscular conditions.~   "
54716|NCT02340910|"~     This study will enroll people with SCI who are receiving physical therapy/exercise training.~     The goal is to understand if standing on a platform and receiving WBV prior to training~     results in decreased spasticity and improved walking ability compared to training alone.~   "
54717|NCT02340897|"~     The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis~     of nontuberculous mycobacterial lung disease based on chest computed tomography findings.~   "
54718|NCT02340884|"~     Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress~     Management (PRISM) Intervention for Adolescents and Young Adults with Cancer~      Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients~     with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those~     ages 13-17 (N=50); (2) those ages 18-25 (N=50).~      Study Design: Pilot randomized controlled trial (RCT).~      Primary Objective: To test the efficacy of the Promoting Resilience in Stress Management~     (PRISM) among Adolescents and Young Adults with cancer.~      Primary Outcome: Change in patient-reported resilience (based on score of standardized~     Connor-Davidson Resilience Scale) at 6 months.~      Secondary Outcomes:~        1. Patient-reported resilience at 2, 4, and 12 months~        2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of~          life, and health-behaviors at 6 and 12 months.~        3. Qualitative assessment of patient-reported goals at 6 and 12 months~        4. Development of a cohort of AYA cancer survivors for assessment of long-term~          psychosocial outcomes~      Study Duration: 3 years~   "
54719|NCT02340871|"~     In Israel, because of special qualification in neurogenetics, during a 30 year career ,we~     have found, characterized and treated at least 13 novel neurological diseases. The genetic~     basis was elucidated with geneticist colleagues both in Israel and worldwide. The diseases~     we have found encompass all the fields of pediatric neurology including intellectual~     disability, epilepsy, muscle-nerve disorders, malformations of the brain, microcephaly,~     macrocephaly, cerebellar ataxia, chorea. dystonia, cerebral palsy and many other symptoms~     and signs.~      We are especially interested in consanguineous families, in whom the parents are first or~     second degree cousins. These families often bear autosomal - recessive diseases. If the~     family is informative - with 2 or more affected children - then with current genetic~     techniques there is a good chance of finding the causative gene to this specific disease.~     This is not only a theoretical - academic accomplishment. In practice, after discovering the~     gene, the family is given genetic counseling and in their further pregnancies the~     geneticists will examine either by preimplantation genetic diagnosis (PGD) or amniocentesis~     if the embryo is affected or not. In the early stages of the pregnancy if the embryo is~     indeed affected by the disease caused by the gene we have found and the religious official~     consents, genetic counseling can offer termination of pregnancy to the couple.~      Needless to say, we know the immense burden of an affected child on the family, community~     and society. The parents are guilt-ridden, the affected child draws extensive resources from~     educational, health and rehabilitation authorities. We can contribute to the well-being of~     the family and the clan (because many times the relatives are affected).~      We can perform sophisticated genetic studies such as Whole Genome Sequencing and Whole Exome~     Sequencing.After an informative family is recruited to the study, we will explain the aims~     of the research. The parents and eligible patients will sign informed consent forms,~     according to the local Helsinki Board. Blood samples will be taken in Israel, DNA extracted~     in the Israeli lab and then shipped coded to the researchers in USA or Germany. If the~     researchers will find a new gene the family will be notified and given appropriate genetic~     counseling. We will continue to follow and treat the family onwards.~   "
54720|NCT02340858|"~     This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating~     patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore~     on the cell membrane and inducing target cell death.This may be an effective treatment for~     patients with unresectable breast cancer.~   "
54721|NCT02340845|"~     The Phase II randomized, two-armed clinical study will investigate the efficacy of high dose~     versus low dose Bromelain (Comosain) in human subjects diagnosed with advanced late stage~     cancers. The study subjects will be randomly assigned to each group by a coin toss.~     Bromelain (Comosain) extract, derived from the stem and fruit of Ananas Comosus will be~     administered orally each day.~   "
54722|NCT02340819|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also~     look at how teduglutide moves through the body (pharmacokinetics).~   "
54749|NCT02340468|"~     In the field of cancer treatment, it is generally accepted that the enhancement of oxygen~     delivery to tumors can augment the effect of anti-cancer therapies. In the case of~     chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment~     reaching the tumor and having an effect.~   "
54723|NCT02340806|"~     Administration of anesthetic solution into the epidural space is usually accomplished by a~     combination of continuous infusion, provider-administered boluses and patient-administered~     boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining~     labor analgesia is unknown. Several studies have demonstrated that timed-intermittent~     boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior~     maintenance of labor analgesia than maintenance with a continuous infusion with PCEA.~     Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA~     recently became commercially available. Several infusion rates are available for delivering~     the timed bolus, and the optimal bolus rate is unknown.~   "
54724|NCT02340793|"~     National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight~     loss maintenance can be achieved in around 33% of patients at 12 months.~      The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet~     Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and~     Weight Loss Maintenance programmes.~      The study will incorporate three work packages with the aim of:~        1. examining changes in body composition with substantial (target >15kg) non-surgical~          weight loss (work package 1, WP1)~        2. characterizing the metabolic adaptations during weight loss and maintenance (work~          package 2, WP2)~        3. examining Rescue Packages as a method of weight re-gain prevention (work package 3,~          WP3).~   "
54725|NCT02340780|"~     The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic~     lymphocytic leukemia.~   "
54726|NCT02340767|"~     The study will determine whether dentists who use a diagnostic device treat suspicious~     occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less~     frequently, than dentists not relying on a diagnostic device. The study will also determine~     -- among those SOCLs that are opened -- whether the proportion of lesions that extend into~     the dentin when dentists are using a diagnostic device is more than, the same, or less than~     when no device is used.~   "
54727|NCT02340754|"~     The primary purpose of this study is to assess the feasibility of mindfulness-based stress~     reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives~     are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life~     compared to an education control group; and 2) Explore the durability of the effects of MBSR~     over one year.~   "
54728|NCT02340741|"~     Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in~     the early postoperative period after open cardiac surgery.~   "
54729|NCT02340728|"~     The purpose of this study is to compare the effects good and/or bad of combining~     radiofrequency ablation with placement of a second stent, versus a second stent alone. The~     investigators will also look at the safety of the combination treatment, and see which~     treatment is better. In either case, the second stent will be placed inside the existing~     stent as is done in standard practice when treating a blocked stent for the first time.~   "
54730|NCT02340715|"~     The purpose of this study is to determine if it would be helpful to use advanced MRI imaging~     techniques to take additional views of the tumor target for radiation treatment planning or~     treatment follow-up MRI.~   "
54731|NCT02340702|"~     The presence of chronic obstructive pulmonary disease (COPD) would confer increased~     in-hospital mortality and length of hospital stay in patients with acute decompensated heart~     failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute~     decompensated heart failure and (2) the association between COPD and in-hospital mortality~     or length of stay in this cohort.~   "
54732|NCT02340689|"~     Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo~     RKSC research staff.~   "
54733|NCT02340676|"~     This research study is evaluating a combination of a therapy called Extra-corporeal~     Photopheresis (ECP) with a drug called Interleukin-2 (IL-2) as a possible treatment for~     chronic graft-versus-host-disease (GVHD) following allogeneic stem cell transplant.~   "
54734|NCT02340663|"~     Clinical trials of bite splint use and night time tooth grinding have not been performed.~     Consequently, there are no definitive outcome measures or efficacy standards that can be~     applied to large clinical trials. The present preliminary trial will determine what~     objective measures can be used to evaluate efficacy. The outcome variables will fall into~     four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4)~     user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night~     guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the~     acrylic 'bite splint' or 'orthotic', hereafter called the Michigan bite splint, to compare~     the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use~     the outcome variables identified in this study for broader clinical trials.~      Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint~     in clinical laboratory conditions. Hypothesis: There will be no significant differences~     between the devices in terms of fabrication efficacy, functional efficacy or user~     satisfaction.~      Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint~     under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will~     be no significant differences between the devices in terms of compliance or functional~     efficacy.~   "
54735|NCT02340650|"~     This is a pilot study involving 100 subjects. The primary aim will be to conduct image~     analysis with the use of High resolution micro-endoscope on the profile of normal bladder~     tissue, inflamed bladder tissue, suspicious bladder tissue and bladder cancer tissues . The~     secondary aim will be to examine the effectiveness of the new (HRME) device for early~     diagnosis of bladder cancer with less invasive procedure. This is a pilot study examining~     imaging analysis in patients with normal bladder tissue, inflamed bladder tissue, suspicious~     bladder tissue, and bladder cancer who are scheduled to have cystoscopy.~      This is a cross sectional study therefore, each patient will participate only once in this~     study. The study involves only 1 visit: Visit #1: schedules cystoscopy and biopsy procedure~     that are part of standard care and then capturing image with the use of HRME device as a~     part of research procedure.~      All the procedures performed in this study are normally done in the work-up of patients~     scheduled to have cystoscopy procedure and is considered a routine procedure for bladder~     cancer screening. The only procedure/treatment which is not routine is the use of High~     resolution microendoscope. Biopsy will be taken at the time of cystoscopy that involves~     standard of care. Images taken by HRME device will then be correlated with pathology results~     of the biopsied tissue. The samples will be coded and de-identified data will be sent to Dr.~     Kortum's laboratory for correlation.~      The blood and urine samples collected during the screening visit are routine tests for~     patients with bladder cancer and will be handled according to standard of practice. The test~     results will be included in the subject's research and medical charts. Additional research~     related information will be provided at the end of the study.~      Risks include those related to cystoscopy and HRME device may include infection, pain,~     difficulty with urination and blood in urine, perforation.~      Potential benefits may include to this subject class for early detection of bladder cancer~     with minimal invasive technique.~      Understanding the effects of HRME device on the bladder screening may improve screening and~     detection methodologies for future patients with bladder cancer.~   "
54736|NCT02340637|"~     The purpose of this study is to provide knowledge regarding the effect of early intervention~     and prevention on the development of anxiety and depression in children. The focus of the~     intervention is to reduce symptoms of anxiety and depression and help children develop~     skills to enhance self-esteem in order to improve life quality. Gender and ethnicity will be~     studied as moderating factors. Primary care givers will be trained in the use of evidence~     based methods for children with internalizing difficulties. Children in need will be~     identified and receive improved services, based on international standards. Active~     collaboration will be established nationally between three Centers for child and adolescent~     mental health (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple~     University in Philadelphia and Kevin Stark at University of Texas at Austin.~      Primary aims are to examine if an indicated group and school based program, Coping Kids, is~     more effective than treatment as usual (TAU) in reducing high levels of symptoms of both~     anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable~     over 12 months.~   "
54737|NCT02340624|"~     Tobacco smoking in pregnancy remains one of the most important and preventable cause of~     adverse pregnancy outcomes. Data from National Survey of Drug Use and Health (NSDUH)~     suggests, that the annual average rates of current cigarette use among women aged 15 to 44~     who were not pregnant decreased from 30.7 percent in 2002-2003 to 24.0 percent in 2012-2013.~     However, the prevalence of cigarette use among pregnant women in this age range did not~     change significantly during the same time period (18.0 percent in 2002-2003 and 15.4 percent~     in 2012-2013)Smoking cigarettes during pregnancy and nursing causes considerable health~     damage to the fetus and to the infant during the initial growth phase. An estimated 19.8~     million women in the United States smoke. Nationally, 23 percent of women report smoking in~     the 3 months before pregnancy, while 13 percent report smoking in the last 3 months of~     pregnancy. Overwhelming evidence suggests that maternal smoking during pregnancy is~     associated with an adverse pregnancy outcomes including IUGR, placenta previa, abruption~     placentae, preterm premature rupture of membranes, low birth weight, perinatal mortality,~     intrapartum stillbirth and ectopic pregnancy. Moreover, prenatal exposure to tobacco smoke~     also increases risk of attention deficit and hyperactivity disorder (ADHD) and sudden infant~     death syndrome (SIDS) in the offspring.Children born to mothers who smoke during pregnancy~     are at increased risk of asthma, infantile colic, and childhood obesity.~      Brief interventions are shown to be associated with small but clear increases in smoking~     cessation in pregnancy, but are rarely used. Technology may fill this void. For the present~     study, pregnant women reporting smoking during pregnancy will be recruited and randomly~     assigned to one of eight combinations of three technology-delivered intervention approaches:~     Brief intervention, Quitline referral, and SmokeFreeMoms text messages~     (http://women.smokefree.gov/smokefreemom.aspx).~   "
54738|NCT02340611|"~     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see~     how useful adding investigational drug cediranib to olaparib after disease progression on~     olaparib alone in patients with ovarian cancer.~   "
54739|NCT02340598|"~     Randomized trial of supplying a cold vest as compared with controls (no cold vest) on~     cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight~     and also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to~     being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as~     long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering.~     The remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are~     checked at baseline, after 2 months and after 1 year.~   "
54740|NCT02340585|"~     The primary objective of this study is to demonstrate effectiveness and safety of the~     Neuroform Atlas Stent System for use with bare metal embolic coils.~   "
54741|NCT02340572|"~     Anticalins® are engineered human proteins that are able to bind specific target molecules.~     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin~     and is intended for treatment of anemia of chronic disease. This phase I First-in-Human~     study shall investigate safety and pharmacokinetics in healthy human volunteers.~   "
54742|NCT02340559|"~     The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in~     people with a brief psychotic disorder, especially positive symptoms.~      The secondary objectives would be to assess the effect of EMC on metacognition (cognitive~     distortions and deficits in theory of mind), psychosocial functioning and quality of life,~     neuropsychological functioning and gender, as well as determine the changes produced by EMC~     in the insight of each session and the maintenance of the effects of EMC program at six~     months of treatment.~   "
54743|NCT02340546|"~     In chronic systolic heart failure patients submitted to cardiac resynchronization therapy,~     the study aims at assessing whether geometric variations in coronary sinus lead tip~     trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are~     predictive of the volumetric and clinical response to the treatment at six-month follow-up.~   "
54744|NCT02340533|"~     The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy~     for diagnosing adenomyosis.~   "
54745|NCT02340520|"~     This is a pilot study designed to evaluate the effects of theophylline and roflumilast on~     circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator~     effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive~     to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by~     measurement of circulating HDAC and the acute effect of oral prednisone on the~     bronchodilator response to inhaled beta agonist. Roflumilast tablets will be added to the~     theophylline for a further week and the studies repeated. The study will provide preliminary~     data on the effects of theophylline and roflumilast on circulating HDAC levels and the~     effects of corticosteroids on the beta agonist bronchodilator response in COPD.~   "
54746|NCT02340507|"~     This study is carried out to find out the inclusion of high and low glycaemic Index (GI)~     foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.~   "
54747|NCT02340494|"~     This project proposes to develop and test an internet resource - a supported self-management~     website - that will guide younger women to relevant knowledge and resources, and provide~     tools that will help YWBC become more skilled and confident in coping with the many~     challenges of breast cancer. The study will be conducted in collaboration with the newly~     funded, pan-Canadian Young Breast Cancer Cohort (CYBCC) program being led from Women's~     College Hospital. The resource is expected to reduce knowledge gaps experienced by YWBC, and~     help them be partners in decision-making about their care, which has been shown to reduce~     anxiety and depression years later.~   "
54748|NCT02340481|"~     The purpose of this study is to evaluate the efficacy and safety of combined loperamide~     hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating~     acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas~     accumulation.~   "
54750|NCT02340455|"~     Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA,~     an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting~     hyperalgesia. If the GABA level can be maintained at certain level, the progression into~     hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative~     opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the~     effective postoperative pain management and the prevention of hyperalgesia from pregabalin,~     GABA analogue, and the possible sex difference in such effects of pregabalin.~   "
54751|NCT02340442|"~     Maternal obesity, overweight and hypertensive disorders are among the most important risk~     factors for complications during pregnancy. Several lines of evidence indicate that~     overweight or obese women, as well as women with hypertensive disorders show increased risks~     of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic~     factor which allows for the early identifications of risk patients is still lacking.~     Recently, it has been reported that assessment of endothelial function may be a new~     promising tool for predicting the risk of adverse pregnancy outcome. As such evidence has~     been provided that endothelial dysfunction is prevalent among women with preeclampsia and is~     able to identify women at increased risk of preterm delivery and small-for-gestational-age~     (SGA) births. Several lines of evidence indicate that functional and structural changes of~     retinal vessels are altered in vascular related disease and may predict cardio-vascular~     events. Consequently, the current study seeks to investigate whether flicker induced~     vasodilatation, a well established parameter to test vascular function in-vivo is altered in~     women with low and high risk pregnancies when compared to a healthy control group. The data~     gained from this study may provide the basis for a larger longitudinal trial to assess~     whether vascular changes in the retina may predict the risk for complication during~     pregnancy.~   "
54752|NCT02340429|"~     Medical care today is moving towards patient centered care (PC) and patient empowerment~     (PE), both in practice and in medical staff training . Applying this methodology enhances~     patient autonomy in the clinical setting and allows shared decision making.~      Current mobile and video technology enables the caregiver(clinician) to share visual data~     with the patient, making him or her a more active participant in the medical procedure. It~     has been shown that higher patient satisfaction rate regarding the patient/physician~     encounter, has a positive effect on medical procedure outcome and patient compliance.~      Patient centered care and Patient Empowerment benefits are maximized using the proper tools.~     One such tool is the video otoscope. In this study we apply the PC/PE approach of medical~     care and introduce video otoscopy in the setting of a pediatric emergency room. We use an~     affordable (~300$), FDA approved, High Res. video otoscope. (DE500 Digital Video~     Otoscope,Firefly global Inc.) Patients will be randomized upon admission into two groups:~     video otoscopy and standard otoscopy. Upon discharge from the pediatric ER, parents will be~     asked to answer a short questionnaire regarding their satisfaction with the ER visit and the~     otoscopic examination.~      We aim to study the impact of affordable, high res. video otoscopy, on the general~     satisfaction of parents from their emergency room experience, vs their experience when~     undergoing a regular otoscopic examination.~      Inclusion criteria: children under 18y admitted to the pediatric ER for any reason,~     undergoing routine otoscopy, who's parents have signed an informed consent.~      Exclusion criteria: no parental informed consent,lake of compliance or inability to perform~     otoscopy.~      Number of participants: 60 (30 in each group) Study start: January 2015 Study ends:January~     2016 Study location: Ziv medical center, Zefat Israel~   "
54753|NCT02340416|"~     Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The~     primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound~     software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous)~     ME, detected as high-intensity transient signals (HITS) in both middle cerebral arteries~     (MCAs) before and after orthopaedic surgery.~   "
54754|NCT02340403|"~     Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling~     neuropathic pain that can last for months or even years after the end of chemotherapy.~     Currently, there is no effective neuroprotective treatment to prevent or relieve this pain.~     The only strategy is the reduction of oxaliplatin doses or premature discontinuation of~     therapy, with the risk of burdening the prognosis for remission. Thus, a better~     understanding of the pathophysiology of these iatrogenic neuropathies appears necessary in~     order to discover new potential therapeutic targets.~      Preclinical works were able to demonstrate important metabolic changes in certain brain~     structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of~     choline concentration has been found in the posterior insular cortex of neuropathic animals~     compared with control animals. Furthermore, the concentrations of choline were positively~     correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would~     involve the posterior insular cortex and would be associated with an increase in choline~     concentration at this level. Clinical translation of these preclinical results is feasible~     in practice since choline concentration can be determined in the brain by non-invasive~     magnetic resonance spectroscopy.~   "
54755|NCT02340390|"~     Evaluate the safety and effectiveness of patients who received G7 Acetabular system in~     conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem~     compared to patients who received the Exceed ABT Acetabular system with the same combination~   "
54756|NCT02340377|"~     The primary objective of the proposed study is to determine the use of a wireless method to~     monitor and record core body temperature during a Whole Body Hyperthermia treatment,~     compared to an indwelling rectal thermometer.~      This protocol is intended to study the differences between a rectal temperature probe and an~     approved wireless and indigestible thermometer during a WBH session. The current standard in~     monitoring core body temperature is the usage of an indwelling rectal thermometer. Many~     patients and potential study subjects, however, decline receiving the treatment, due to the~     discomfort of using this measuring method and a wireless measuring device would open the~     possibility for those patients to receive a treatment. The primary endpoint for example of a~     treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C.~     However, due to the proximity of the probe to the body's surface, the core body temperature~     will vary from the rectal temperature and the comparison between the two methods with a~     validation of the wireless device is necessary.~      The investigators will monitor subject's physiological outcome from a single Whole Body~     Hyperthermia treatment in an open fashion (no placebo/control condition). This study will~     include safety assessments 7 days several days prior to or same day as the WBH, and include~     follow-up assessments 1 day and 1 week later.~   "
54770|NCT02340195|"~     The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine~     following multiple dosing in patients with renal impairment and compare to those in healthy~     subjects~   "
56188|NCT02321657|"~     RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an~     iPad app with art, music and games to relax and distract children, reduce anaesthetic~     induction time and make drug cost savings prior to surgery.~   "
54757|NCT02340364|"~     The investigators are asking subjects to take part in the Patient NAVIgation to Reduce~     Readmissions among Black Men with Heart Failure (NAVI-HF) research study. This research~     study will test how well trained laypeople working as patient navigators will help patients~     recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new~     program sponsored by funding from the National Institute of Minority Health and Health~     Disparities. People who enter into the study will work with a patient navigator to undergo~     the full program or work with a trained layperson to receive general education on heart~     disease treatment and prevention. The purpose of the study is to determine whether a patient~     navigation program will be effective in reducing the number of hospitalizations in the~     future for program participants. This study will enroll 416 participants from UAB.~   "
54758|NCT02340351|"~     The purpose of this study is to determine whether auricular acupuncture (AA) according to~     the NADA protocol and progressive muscle relaxation (PMR) differ in their effectiveness of~     treating people with anxiety disorders or major depressive disorder. We hypothesized, that~     both treatments show significant effects in alleviating the examined items (tension,~     anxiety, anger/aggression and state ofr mood) and that there is no significant difference~     between these two treatments.~   "
54759|NCT02340338|"~     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from~     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy.~      The aim of this study is to demonstrate the safety and tolerability of the BioMed~     recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The~     second aim of the study is to measure antibodies in the blood of these healthy volunteers~     which have been produced in response to treatment with the BioMed rTSST-1 Variant Vaccine.~     These antibodies are expected to be important in resistance against the diseases. 46 healthy~     adults, male and female, age 18-64 years will be assigned to 6 dose groups of the vaccine at~     the Department of Clinical Pharmacology of the Medical University of Vienna. The patients~     will be monitored for vital signs, hematology, clinical chemistry, blood cytokine level and~     antibodies against TSST-1. Immunization will be repeated 4 weeks after the first with the~     same dose.~   "
54760|NCT02340325|"~     Background Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic~     scarring presents as raised, red and itchy lesions which variably respond to various~     treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of~     silicone sheets and radiotherapy.~      Kynurenine, or Fibrostop 1 (FS1), and its further breakdown products, such as kynurenic~     acid, or Fibrostop 2 (FS2), are endogenous products found in many systems and have shown~     potential in reducing scar formation in animal studies.~      The aim of study is to evaluate the safety and tolerability of FS2 cream applied to the skin~     of healthy human subjects.~   "
54761|NCT02340312|"~     Recurrent abdominal pain has long been acknowledged to be the most common chronic pain~     entities in children. The purpose of this study is to describe the microbiome in children~     with FD and to explore relationships between the microbiome and postprandial distress~     syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this~     study are to: 1) Determine the frequencies and relative proportions for specific bacteria or~     bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2)~     Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ~     between children with and without PDS. 3) Determine bi-variate correlations between~     bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal~     biomarkers, respectively.~   "
54762|NCT02340299|"~     To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately~     after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours~     after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in~     very low birth weight infants (VLBWs).~   "
54763|NCT02340286|"~     The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old~     children.~   "
54764|NCT02340273|"~     Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon~     injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase~     tendon strength, and improve quality of life for patients with tendon injury.~   "
54765|NCT02340260|"~     Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but~     few patients exercise according to guidelines. In this study the effect of two time~     efficient high intensity exercise protocols on glycemic control and other cardiometabolic~     risk factors are investigated in patients with type 2 diabetes.The investigators assume that~     glycemic control is improved more by low-volume high intensity interval training than by~     extremely low-volume sprint interval training.~   "
54766|NCT02340247|"~     The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after~     Roux-en-Y gastric bypass.~   "
54767|NCT02340234|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and~     efficacy of lebrikizumab administered subcutaneously (SC) in adult patients with moderate to~     severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids~     (TCS). The study includes a screening visit, a 12-week blinded treatment period, and an~     8-week safety follow-up period. During the treatment period, patients will be randomized to~     one of four treatment groups. The planned target sample size is 200 patients.~   "
54768|NCT02340221|"~     This international, multicenter, randomized, double-blinded, placebo-controlled study is~     designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo~     + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal~     growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or~     metastatic breast cancer after recurrence or progression during or after an aromatase~     inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the~     placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central~     testing. The anticipated duration of the study is approximately 3.5 years.~   "
54769|NCT02340208|"~     The primary purpose of this research study is to evaluate how safe, how well tolerated and~     how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung~     cancer when given as a monotherapy.~   "
54771|NCT02340182|"~     The objective of this study is to investigate the role of the gut microbiota in the systemic~     priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will~     be treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for~     seven days, in order to deplete the gut microbiota. Blood and faeces will be sampled before,~     24 hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include~     laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation~     assay) and gut microbiota composition.~   "
54772|NCT02340169|"~     The objective of this study is to evaluate the potential of Topicort® (desoximetasone)~     Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary~     objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event~     profile.~   "
54773|NCT02340156|"~     This Phase II clinical trial is an open label, single arm, multicenter study of the~     combination of intravenously administered SGT-53 and oral temozolomide in patients with~     confirmed glioblastoma who have proven tumor recurrence or progression. The objective of~     this trial is to assess 6 month progression free survival (PFS), overall survival (OS),~     anti-tumor activity, safety and possibly to evaluate, nanoparticle delivery to tumor site,~     and the induction of apoptosis in the tumor..~   "
54774|NCT02340143|"~     The study is intended to assess the amount of crying and fussiness in infants fed an infant~     formula containing probiotics.~   "
54775|NCT02340130|"~     This is an open-label, non-controlled, non-randomised, prospective safety study in patients~     with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically~     relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.~   "
54776|NCT02340117|"~     This clinical trial is an open label Phase II study of the combination of intravenously~     administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic~     cancer as a first-line treatment. The objective of the study is to evaluate the safety,~     tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month~     (PFS5.5mos)) of this combination therapy.~   "
54777|NCT02340104|"~     The pupose of this study is to compare how much baricitinib (study drug) gets into the blood~     stream when it is given as a single dose (in tablet form) and as an intravenous infusion~     (injection given directly into a vein via a small needle). Each participant in the study~     will make four visits to the investigator site over the course of about 6 weeks.~   "
54778|NCT02340091|"~     The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with~     lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).~   "
54779|NCT02340078|"~     The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with~     lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).~   "
54780|NCT02340065|"~     The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible~     additive contribution in the detection of important lesions, namely polyps and cancers,~     compared to standard colonoscopy, in a series of patients undergoing back-to-back screening~     or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible~     changes regarding post-polypectomy surveillance programs following Endocuff utilization.~   "
54781|NCT02340052|"~     This is a prospective observational cohorte study. The aim is to investigate actual pain~     treatment and outcomes in a large population of total hip arthroplasty patients at 5~     different hospitals in Denmark.~   "
54782|NCT02340039|"~     Raised blood glucose levels can lead to adverse modifications to functional proteins within~     the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may~     help to control glycaemia following a carbohydrate meal or beverage. The aim of this study~     is to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial~     glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a~     mixed carbohydrate test meal.~   "
54783|NCT02340026|"~     The purpose of this study is to determine the optimal treatment duration of a novel early~     mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of~     treatment; and to evaluate the clinical futility of this intervention compared to current~     rehabilitation practice.~   "
54784|NCT02340013|"~     This is a pilot study examining the feasibility of implementing a large randomized control~     trial looking at the effect of endometrial shedding with medroxyprogesterone acetate~     compared to no pre-treatment in women taking clomiphene citrate for ovulation induction for~     infertility due to oligo-ovulation or anovulation.~   "
54785|NCT02340000|"~     The aim is to determine if high-dose amoxicillin/clavulanate is more effective than~     standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen~     at a primary care office.~   "
54786|NCT02339987|"~     Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)~   "
54787|NCT02339974|"~     The goal of this study is to determine the short term safety (<30 days) and mid and long~     term efficacy (6 months and >1-year) of the heterotopic implantation of the Edwards-Sapien~     XT valve in the inferior vena cava for the treatment of severe tricuspid regurgitation in~     patients who are inoperable or at a very high surgical risk for tricuspid valve replacement.~   "
54788|NCT02339961|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package- the Transthoracic~     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung~     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in~     detecting PAH in SSc patients will be assessed in the study.~   "
54789|NCT02339948|"~     Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0,~     Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients~     (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy~     for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7)~     will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will~     then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.~   "
93465|NCT01833767|"~     The purpose of this study is to determine response rates by administering low dose~     cyclophosphamide on day 1, followed by 5 days of outpatient IL2.~   "
54790|NCT02339935|"~     This study aims to implement and test a specific brief Applied Behavior Analysis model for~     assessing and responding to severe challenging behavior during acute medical and behavioral~     hospitalization for children with ASD. The investigators will evaluate the impact of this~     program by conducting a randomized trial across both medical and psychiatric hospital~     settings.~   "
54791|NCT02339922|"~     This phase II trial studies how well ixazomib citrate and rituximab work in treating~     patients with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by~     targeting certain cells. Giving ixazomib citrate together with rituximab may work better in~     treating indolent B-cell non-Hodgkin lymphoma.~   "
54792|NCT02339909|"~     This trial is a randomised controlled trial to assess whether annual attendance rates at~     diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved~     by offering invitees a small financial incentive. The research questions are:~        1. Are incentives an effective strategy to encourage participation in the screening~          programme?~        2. Does the design of the financial incentive scheme affect its effectiveness in~          influencing participation in health screening?~        3. Does the choice of incentive scheme, if successful, attract patients who have a~          different demographic or socioeconomic status to those who attend screening regularly?~        4. Is offering these incentives a cost-effective strategy for enhancing participation?~   "
54793|NCT02339896|"~     To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New~     Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies~     intradermal regimen with or without Rabies Immunoglobulin in Children~   "
54794|NCT02339883|"~     Background:~      - Magnetic resonance imaging (MRI) creates high-quality images of the human body without~     x-rays. It uses a strong magnetic field and radio waves to take pictures. Researchers want~     to test a scanner that uses a high magnetic field strength.~      Objective:~      - To study how the body responds to being in a high field 11.7T MRI scanner.~      Eligibility:~      - Healthy people ages 22 65.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will~          complete a healthy volunteer questionnaire and an MRI safety screening form. They may~          have a 3T MRI scan of the brain.~        -  Participants will have an MRI scan. They will lie on a table that will slide in and out~          of the MRI cylinder very slowly. They will be asked to lie still.~        -  Participants will do simple tasks while inside the machine. These can include listening~          and responding to questions, tapping fingers, or moving a hand.~        -  While in the scanner, participants will hear loud knocking noises. They will get~          earmuffs.~        -  Right when they exit the scanner, participants will get a questionnaire to fill out.~          This will ask about how they felt inside the scanner.~        -  During the MRI, participants heart rate, respiratory rate, and skin temperature will be~          measured. Before and after the scan, these things plus blood pressure will be measured.~        -  Participants will be tested before and after being in the MRI scanner. They will answer~          questions, take pen-and-paper or computer tests, and do simple actions. Their sense of~          smell may be tested.~   "
54795|NCT02339870|"~     This randomized clinical trial studies expressive writing in improving the wellbeing or~     comforting capacity of caregivers of patients with cancer. Expressive writing is a type of~     intervention that asks people to write about important topics (in this case participants'~     experience with their spouses'/partners' cancer) and their emotions/feelings surrounding~     them. Expressive writing, including benefit finding and traumatic disclosure, may be a type~     of at-home-therapy that caregivers can utilize in an attempt to increase their own~     wellbeing, offer better comfort to cancer patients, and by association, help cancer patients~     cope with and manage the cancer experience.~   "
54796|NCT02339857|"~     The purpose of this study was to investigate whether the no-touch saphenous vein grafts that~     were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable~     to the left internal thoracic artery when the vein grafts were anatomised to the left~     anterior descending artery.~   "
54797|NCT02339844|"~     The study is a prospective 2 year multimodal follow-up study of initially~     antipsychotic-naïve first-episode psychotic patients involving a standardized intervention~     with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy~     controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with~     MR-scannings, neurocognitive tests, EEG, and PET-scannings.~   "
54798|NCT02339831|"~     The purpose of this study is to determine how well an active motion device, Camoped, works~     compared to a continuous passive motion device, CPM, for rehabilitation after partial or~     total knee replacement. It is hypothesized that the Camoped active motion device will~     provide outcomes equal to or superior than the CPM. Patients undergoing either partial or~     total knee replacement will be given the opportunity to participate. If they elect to~     participate, preoperative data will be collected including demographics, measures of~     strength, balance and knee bending, as well as surveys regarding current physical and mental~     health, as well as knee function. After surgery, patients will be randomly selected to~     receive either the Camoped or the CPM for use during their rehabilitation. After discharge,~     participants will be asked to maintain a daily diary tracking their use of the assigned~     device, as well as their daily pain levels. At a visit 4 weeks after surgery, participants~     will be asked to complete a series of surveys pertaining to their health and knee function,~     as well as to perform tests of strength, balance and knee bending. These results will be~     used to determine if one device produces superior rehabilitation results following total or~     partial knee replacement surgery.~   "
54799|NCT02339818|"~     The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber~     Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding~     associated with Eliquis treatment communicated by the RM tools.~   "
54800|NCT02339805|"~     This is a prospective descriptive monocentric study whose purpose is to describe the clonal~     evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large~     B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment~   "
54801|NCT02339792|"~     This randomized controlled pragmatic study is aimed to set-up, assess and implement an~     integrated e-learning program of medical education in an hospital setting, focused on~     teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve~     the quality of drug prescribing in elderly patients~   "
54802|NCT02339779|"~     This multicentre randomized controlled trial aims to evaluate a new breast reconstruction~     technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to~     receive a mastectomy (or having undergone mastectomy in the past) will be randomized to~     undergo breast reconstruction with either AFT (intervention group) or reconstruction with~     implants (control group). AFT will be evaluated in terms of quality of life, aesthetic~     result, complications, oncological safety and cost-effectiveness.~   "
54803|NCT02339766|"~     Most women having planned cesarean section receive spinal anesthetic for the procedure.~      Typically, spinal opioids are administered during the same time as a component of multimodal~     analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal~     opioids are frequently associated with adverse effects such as nausea, pruritus, sedation~     and occasionally respiratory depression.~      The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve~     branches and has an evolving role in postoperative analgesia for lower abdominal surgeries~     and is a potential alternative to spinal opioids. There is some evidence that it may provide~     visceral along with somatic pain relief. It is a simple and safe technique that has been~     studied in lower abdominal surgeries, but has not been studied for pain relief after~     cesarean section.~      If found effective, it will have the advantage of a reduction in opioid associated adverse~     effects while providing similar quality of analgesia. This block has evolved from the~     previously known transversus abdominis plane block.~      We propose to undertake a study that will compare the relative efficacy of QL block with~     local anesthetic to spinal morphine. We will also study if it provides any incremental~     benefit when administered in addition to spinal morphine.~   "
54804|NCT02339753|"~     Carboplatin is widely used for conditioning regimens of autologous hematopoietic stem cell~     transplantation for pediatric solid tumor, but the pharmacokinetics has not been evaluated~     in pediatric stem cell transplantation before. As carboplatin have renal toxicity, the~     pharmacokinetic study of carboplatin would help the safe and effective administration of~     carboplatin for transplantation patients. Especially, the dose of carboplatin is higher at~     conditioning chemotherapy, resulting in higher toxicity.~      Carboplatin is a drug mostly excreted by kidney, and the dose of carboplatin is recommended~     according to the body surface area and kidney function, represented by glomerular filtration~     rate. After analyzing the pharmacokinetics of carboplatin, analyses will also be done for~     the methods to determine the appropriate carboplatin dose.~   "
54805|NCT02339740|"~     This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly~     diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia~     involves high doses of a common class of chemotherapy drugs called anthracyclines, which are~     known to cause long-term side effects, especially to the heart. Tretinoin may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic~     trioxide may stop the growth of cancer cells by either killing the cells, by stopping them~     from dividing, or by stopping them from spreading. Completely removing or reducing the~     amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may~     be an effective treatment for acute promyelocytic leukemia and may reduce some of the~     long-term side effects.~   "
54806|NCT02339727|"~     It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are~     important in neurodevelopment of term and preterm infants. This study tried to determine the~     utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk~     formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature~     infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate~     values of fatty acids they have in blood and psychomotor development they achieve.~   "
54807|NCT02339714|"~     A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had~     significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture~     or no active treatment. The object of that study was to evaluate the effectiveness and~     safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was~     defined as the only intervention for treatment group and sham acupuncture, no active~     treatment as its control groups. Besides, acupuncture combined moxibustion showed better and~     longer effect than acupuncture on allergic rhinitis patients in our previous pilot study.~     According to this result, we are taking a pragmatic randomized controlled trial to further~     evaluate whether acupuncture combined moxibustion is more effective than conventional~     treatment.~   "
54808|NCT02339701|"~     The primary goal of this phase II study is to comparing the SBRT and IMRT. The hypothesis~     for each arm is that the probability of the change in EPIC HRQOL scores (1-year minus~     baseline) is less than (or equal to) an acceptable limit. If it can be shown that either arm~     is tolerable in terms of patient-reported outcome (PRO) then that hypofractionated regimen~     will be considered for further use in a phase III study.~   "
54809|NCT02339688|"~     Current study will investigate the quality (psychometric properties) and clinical utility of~     several mobility measures, according to disability level. Therefore, several aspects will be~     inquired:~        -  Was there an effect of rehabilitation~        -  Is the measure able to detect change over time? And thus the change exceed measurement~          error and is it clinically important (responsiveness)~        -  Does the measure assess what it claims to measure (validity)~        -  Is the measure able to differentiate all performances of the patients, inclusively the~          very good and very bad performances (floor and ceiling effects)~        -  Does the measure gives similar results under consistent test conditions on another~          testing day (reliability) Worldwide, theoretical approaches to physical therapy and~          rehabilitation in Multiple Sclerosis often appear significantly different. Since the~          present research protocol will be performed at different centers across European~          countries (and US sites), this multi-center study can additionally be applied for~          mapping the volume and content of rehabilitation, as well as the differential impact of~          diverse rehabilitation approaches and training volume on mobility, for several~          disability levels.~      Some health-economic analyses will be performed to examine what the approximate cost of~     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,~     staff).~   "
54822|NCT02339519|"~     This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and~     LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on~     hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and~     systemic complications.~   "
54810|NCT02339675|"~     Current study will investigate de quality (psychometric properties) and clinical utility of~     several measures of upper limb function, according to disability level. Therefore, several~     aspects will be inquired:~        -  Was there an effect of rehabilitation~        -  Is the measure able to detect change over time? And thus the change exceed measurement~          error and is it clinically important (responsiveness)~        -  Does the measure assess what it claims to measure (validity)~        -  Is the measure able to differentiate all performances of the patients, inclusively the~          very good and very bad performances (floor and ceiling effects)~        -  Does the measure gives similar results under consistent test conditions on another~          testing day (reliability) Worldwide, theoretical approaches to physical therapy and~          rehabilitation in Multiple Sclerosis often appear significantly different. Since the~          present research protocol will be performed at different centers across European~          countries (and US sites), this multi-center study can additionally be applied for~          mapping the volume and content of rehabilitation, as well as the differential impact of~          diverse rehabilitation approaches and training volume on mobility, for several~          disability levels.~      Some health-economic analyses will be performed to examine what the approximate cost of~     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,~     staff).~   "
54811|NCT02339662|"~     The purpose of the study is comparing two drugs efficacy for the treatment of pain~     originates from masticatory muscles. The two drugs are - Amitriptlyne (amitriptyline) and~     Gabapentin (gabapentin), both of them are common use in for the treatment of chronic pain~     Methods - patient that is diagnosed as suffering from myofacial pain, will receive one of~     the medications above (Gabapentin or amitriptyline) for one month only, after which he will~     be invited to pain clinic for control. Two weeks after that, the patient will start taking~     the other drug for 1 month and then invited again to the department for recall and continue~     standard treatment . The patient can choose whether to continue medication with one of the~     drugs or stop this medication treatment. Total duration of the experiment is two and a half~     months.~   "
54812|NCT02339649|"~     The main goals of this study are to provide a cognitive, neurological, brain morphological,~     and serological profile of sepsis survivors in order to make long-term prognosis of recovery~     and estimate the need for rehabilitation measures in order to help patients reintegrate into~     normal daily life.~   "
54813|NCT02339636|"~     A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis~   "
54814|NCT02339623|"~     If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland~     volume can accurately predict the likelihood of preterm birth in patients having symptoms~     and signs of PTL , we would be able to use it as a valuable component for assessment and~     early management of high risk pregnant women for PTB which can be positively reflected on~     the risk of neonatal morbidity and mortality in those patients.~   "
54815|NCT02339610|"~     This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from~     the time of surgery through the 6 month endpoint in patients with severely painful and/or~     severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).~   "
54816|NCT02339597|"~     Primary hypothesis:~      The objective compliance ( # of hours per night of APAP therapy) is higher in patients who~     get the APAP treatment initiation at home due to the fact that they get better support by~     telemetric control and the possibility of prompt interventions.~      Secondary hypothesis:~      Based on the higher support at the home APAP initiation the following parameters will be~     better in comparison to the standard supply in laboratory:~      Objective measures:~        -  mask leakage~        -  pressure~        -  Apnea-Hypopnea-Index (AHI)~      Subjective measures:~        -  quality of life~        -  sleepiness~   "
54817|NCT02339584|"~     The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL /~     Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide~     10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect~     to intraocular pressure (IOP)-lowering efficacy. This study will take place in China,~     Taiwan, and Russia.~   "
54818|NCT02339571|"~     This randomized phase II/III trial studies the side effects and best dose of nivolumab and~     ipilimumab when given together with or without sargramostim and to see how well they work in~     treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal~     antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to~     the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking~     specific tumor cells and stop them from growing or kill them. Colony-stimulating factors,~     such as sargramostim, may increase the production of white blood cells. It is not yet known~     whether nivolumab and ipilimumab are more effective with or without sargramostim in treating~     patients with melanoma.~   "
54819|NCT02339558|"~     This phase II trial studies how well nivolumab works in treating patients with~     nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has~     spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab,~     may block tumor growth in different ways by targeting certain cells.~   "
54820|NCT02339545|"~     This is an acute, observational, prospective, multi-center clinical study to evaluate~     Coronary Flow Reserve using the Volcano FloWire® after treatment with Orbital Atherectomy~     and stenting of de-novo severely calcified lesions due to Coronary Artery Disease. 15~     subjects will be enrolled in up to 3 active U.S. study sites. Subjects who undergo~     successful revascularization using Orbital Atherectomy and stenting will be eligible for~     enrollment. All enrolled subjects will be treated with the OAS and stenting and seen at 24~     hours or at discharge, whichever is earlier. The purpose of the study is to evaluate~     coronary artery flow reserve following successful treatment of severely calcified coronary~     lesions with the OAS and stenting.~   "
54821|NCT02339532|"~     The main objective of this multicenter study will therefore be to evaluate pathologic~     complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN®~     - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® -~     PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of~     breast cancer patients with HER2 overexpression.~      A very important objective of the study will be the evaluation of biomarkers that predict~     response to treatment.~   "
64818|NCT02208895|"~     Pleural fluid glucose levels measured with bed-side point of care methods such as finger~     stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.~   "
54823|NCT02339506|"~     Models of stress such as hypoglycemia have identified that stress results the next day in~     decreased baroreflex sensitivity. This project will test the hypothesis that these delayed~     changes in autonomic nervous system function are secondary to a rise in ACTH. The~     investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in~     healthy adults and measure the delayed effects on the autonomic system as measured by~     cardiovagal baroreflex sensitivity.~   "
54824|NCT02339493|"~     Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc~     scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter~     confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with~     warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of~     thromboembolic stroke in most patients with AF. However, despite widely available risk~     stratification tools, five options for anticoagulation, and evidence-based practice~     guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S.,~     Europe, and worldwide. The investigators have previously demonstrated the efficacy of an~     alert-based computerized decision support (CDS) strategy for prevention of symptomatic~     venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any~     thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS~     strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a~     randomized controlled trial.~   "
54825|NCT02339480|"~     This project is to penetrate and consummate the research mechanism of massage therapy on~     simple obesity. Latest researches indicate that the energy regulation network system of~     hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result~     in obesity. The research group have firstly conducted effect studies of massage therapy on~     model of simple obesity rats and observed some neurobiological mechanism (whole effect~     mechanism), meanwhile, the team have discussed influences on the development of preadipocyte~     and function of endocrine with dynamic mechanical stimulation in vitro (local effect~     mechanism). This research aims at centering on the hypothesis that massage therapy can act~     on energy regulation network system of hypothalamus specifically, thus regulating the energy~     metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore~     whether patients with simple obesity exist abnormality on energy regulation network system~     of hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders~     of simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity~     and enrich the clinical application's scientific connotation that massage therapy treat~     simple obesity.~   "
54826|NCT02339467|"~     Community walking is an issue that older adults with chronic conditions have described as~     important to participation in the community. Walking outside the home is a universally~     accessible form of physical activity that has multiple health benefits. Walking for 150~     minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,~     diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,~     slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible~     and can improve confidence, balance and walking ability. Being physically active outdoors in~     nature appears to improve mental health more than being active indoors. Despite these health~     benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers~     to walking outside include fear, physical disability due to chronic disease, the~     appropriateness of footwear and walking aids, and the physical environment, such as uneven~     pavement, weather and temperature. To date, the best strategy for getting people to walk~     outdoors regularly is unknown. The investigators propose to evaluate the effectiveness of a~     dynamic 1-day workshop, at which older adults who infrequently walk outdoors learn~     strategies to facilitate outdoor walking, such as appropriate use of footwear, ambulatory~     aids and equipment, goal setting, and practice skills related to increasing outdoor walking.~     The workshop will be compared to the workshop plus involvement in a walking group for 3~     months. Outcomes include outdoor walking activity, total physical activity, walking ability,~     participation, and health-related quality of life. Each participant will have three~     evaluations: before the intervention and 3 and 6 months later. The investigators will~     interview select participants at 6 months to ask them about their opinions of what worked~     and didn't work. Increasing outdoor walking is expected to improve health and well-being,~     and help people live independently in the community for longer.~   "
54827|NCT02339454|"~     Low intensity shockwaves have been proven in animal and pilot clinical studies to induce~     local growth of new blood vessels. Small single-center clinical trials with shockwave~     therapy showed promising results in reducing angina symptoms, improving perfusion and~     contractility in patients with refractory angina and stress-induced ischemia on imaging~     test.~      The hypothesis of this study is that shockwave therapy could improve angina symptoms and~     exercise tolerance in broader population of patients with stable angina regardless of~     imaging test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal~     Shockwave Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical~     treatment in patients with stable angina.~   "
54828|NCT02339441|"~     The aim of the study is to compare the effectiveness of commonly used immunosuppressant~     treatments for early diffuse cutaneous systemic sclerosis (SSc).~   "
54829|NCT02339428|"~     Patients will be randomized to receive diclophenac sodium or placebo two hours before~     diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the~     primary outcome. Patients will be followed until hospital discharge, an average of 10 days.~   "
54830|NCT02339415|"~     The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via~     edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.~   "
54831|NCT02339402|"~     Developing a new non-invasive prenatal test for single gene disorders from cell free fetal~     DNA, retrieved from the mothers blood.~   "
54832|NCT02339389|"~     Epidural techniques offer the advantage of being able to titrate the level, density, and~     duration of the blockade through the use of a catheter and are associated with relative~     maternal hemodynamic stability. One of the disadvantages, however, include a raise in~     maternal temperature that is attributed to labor epidural technique. This study will assess~     if decreased maternal ventilation following induction of labor analgesia causes a raise in~     temperature.~   "
54865|NCT02338947|"~     The purpose of this study is to determine whether off-pump coronary artery bypass graft~     (OPCAB) surgery is superior to conventional on-pump coronary artery bypass graft (CABG)~     surgery in the treatment of Pre-frailty and Frailty patients~   "
54868|NCT02338908|"~     Shoulder pain is highly prevalent in the society. The role of muscle tissues in this~     pathology has received increasing interest. Some studies have proposed the role of~     myofascial trigger points in this population. The purpose of the current clinical trial is~     to compare the effects of physiotherapy treatment consisting of an eccentric exercise~     protocol versus the same physical therapy program plus the addition of trigger point dry~     needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.~   "
54833|NCT02339376|"~     The overall goal of this study is to open up the promising treatment of repetitive~     transcranial magnetic stimulation (rTMS), which has been shown to be effective against~     seizures in patients with surface neocortical foci, to a much larger population of patients~     with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who~     are not currently considered good rTMS candidates.~      The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients~     with deep seizure foci by targeting its usage to accessible cortical partner regions. In~     this study the investigators aim 1) to map the functional connectivity of the epileptogenic~     mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy;~     and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic~     stimulation protocols applied to specific neocortical targets in mesial temporal lobe~     epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of~     the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).~   "
54834|NCT02339363|"~     The present study was a randomized controlled trial that explored the feasibility,~     acceptability, and effectiveness of short-term mindfulness training among adolescents. The~     primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress~     Reduction components—sitting meditation and hatha yoga—on working memory, stress, anxiety~     and mindfulness. The influence of daily home practice compliance on intervention outcomes~     was also examined.~   "
54835|NCT02339350|"~     Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall~     survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%,~     thus recent studies focus on treatment intensification according to the risk group.~     According to the previous reports, we designed a multicenter prospective trial for pediatric~     ALL.~   "
54836|NCT02339337|"~     This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected~     patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The~     definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV)~     and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects~     were randomized into 2 groups at treatment initiation. Subjects who were randomized into the~     genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for~     48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day)~     for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for~     6 months. For subjects who were randomized into the response guided therapy (RGT) group, the~     duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV~     genotype 1, a pre-treatment low viral load (LVL, < 400000 IU/mL) and RVR (defined asHCV RNA~     <50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype~     2/3 and RVR.~   "
54837|NCT02339324|"~     This study plans to to estimate the safety profile of the combination biotherapy regimen~     consisting of standard-dose interferon alpha-2b (HDI) and anti-PD1 monoclonal antibody,~     Pembrolizumab, for the neoadjuvant therapy of locally/regionally advanced/recurrent~     melanoma. Also, the objectives of this trial include the evaluation of prognostic and~     predictive biomarkers, radiologic preoperative response rate, pathologic response rate,~     progression free survival and overall survival. Up to 30 evaluable patients will be accrued.~   "
54838|NCT02339311|"~     One in three people will be diagnosed with diabetes by 2050, and the proportion will likely~     be higher among Native Americans. Diabetes control is currently suboptimal in underserved~     populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is~     a key determinant of diabetes control, but such empowerment can be difficult to achieve due~     to resource limitation and cultural, language and health literacy barriers. The~     investigators will conduct a home-based chronic disease (diabetes) educational intervention~     using Community Health Representatives (CHRs) to associate improvement in Patient Activation~     Measures scores (primary outcome) and clinical indicators of diabetes control (secondary~     outcomes).~   "
54839|NCT02339298|"~     The purpose of the study is to evaluate whether intraoperative music application has a~     positive impact on postoperative behavior in children and adolescents.~   "
54840|NCT02339285|"~     Investigating the effects of non-invasive transcranial alternating current stimulation~     (tACS) on patients with Major Depressive Disorder (MDD).~   "
54841|NCT02339272|"~     The aim of this study was to assess meiotic recombination in primary spermatocytes,~     synaptonemal complex length and the correlation with chromosomal abnormalities in testicular~     spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).~   "
54842|NCT02339259|"~     Background:~      The clinical features and prevalence of tropical rickettsial illnesses such as murine and~     scrub typhus in Bangladesh are unknown. Following testing for malaria, patients with~     undifferentiated fever are frequently treated empirically for typhoid or diagnosed~     clinically with a viral fever. Since murine and scrub typhus are common causes of fever in~     other countries in the region, it is likely they are prevalent in Bangladesh. Murine and~     scrub typhus may be treated cheaply and effectively with doxycycline.~      Primary aim:~      - Describe the clinical features of scrub and murine typhus in Bangladeshi patients~      Secondary aims:~        -  Assess the proportion of patients screened for malaria having rickettsial illnesses~        -  Understand the pathophysiology of severe scrub typhus and murine typhus~        -  Prospective evaluation of rapid diagnostic tests for scrub and murine typhus~      Methods:~      Scrub typhus and murine typhus rapid tests will be introduced to CMCH in conjunction with~     existing malaria testing facilities. Consenting febrile adult patients who have had malaria~     and typhus rapid tests and meeting the entry criteria will be enrolled. Samples will be~     saved for serology and real time polymerase chain reaction (PCR) testing for O.~     tsutsugamushi and Rickettsia spp. A thorough history and examination will be undertaken.~     Hemodynamic status will be assessed by ultrasound upon enrolment. Patients will be followed~     up for outcome and a second sample will be taken for convalescent serological testing on day~     14 where possible.~      Analysis The proportion of patients screened for malaria with an acute febrile illness due~     to scrub typhus and murine typhus will be calculated. The clinical features of scrub and~     murine typhus, malaria and patients negative for these conditions will be compared. Healthy~     subject samples will be used to provide normal ranges. The sensitivity and specificity of~     the rapid tests will be assessed as compared to the gold standard of PCR and serology~     combined.~   "
54843|NCT02339246|"~     The purpose of the study is to compare the pharmacokinetic parameters of three different~     formulations of tacrolimus.~      Eligible patients will be treated with all three formulations in a pre-defined sequence.~   "
54892|NCT02338596|"~     As clinical and radiographic performance of an ultra-short anatomic cementless stem have~     been investigated only two randomized controlled studies, well-designed trials should aim~     for a thorough comparison of the outcomes of ultra-short and conventional cementless stems.~     The purpose of this study was to compare the outcomes of ultra-short and conventional stems~     in the same young patients who underwent simultaneous bilateral sequential total hip~     arthroplasties.~   "
64819|NCT02208882|"~     The purpose of this study is to assess the safety, tolerability and effect on Midazolam~     pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.~   "
54844|NCT02339233|"~     The overall aim is to assess whether task specific locomotor training and spinal cord~     electrical stimulation (SCES) can induce neural reorganization of the functionally isolated~     human spinal cord to improve standing and stepping in individuals with functionally complete~     SCI. The investigators propose that locomotor training will result in generation of more~     effective standing and stepping efferent patterns by restoring phase dependent modulation of~     reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination.~     The investigators propose that the SCES will optimize the physiological state of the spinal~     cord interneuronal circuitry compromised by compensating for loss of supraspinal input for~     the retraining of these tasks.~      The proposed studies will allow us to gather critical information using commercially~     available electrodes to design the more advanced multi-electrode array technique that will~     be adaptive and conceivably be effective in a wider range of patient populations. The~     current electrodes used in this study will serve two objectives: 1) to improve standing and~     stepping with the combination of epidural stimulation and locomotor training in individuals~     with functionally complete SCI; and 2) to provide critical information for the development~     of more advanced electrodes.~   "
54845|NCT02339220|"~     The purpose of this study is to determine the value of Constraint-Induced Movement therapy~     (CIMT) for improving motor function and general fitness in adults with subacute and chronic~     traumatic brain injury (TBI), particularly TBI acquired during active military duty, in~     comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the~     effect of a set of enhanced versus standard procedures for transferring therapeutic gains~     from treatment setting to everyday life. Lastly, this study will determine whether any~     therapeutic effects observed are correlated with neuroplastic white matter or grey matter~     changes.~   "
54846|NCT02339207|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV)~     and subjects with CHC infection.~   "
54847|NCT02339194|"~     BACKGROUND: The literature has shown that simplified methods for complete denture~     fabrication can be as effective as the traditional techniques, but with less expenditure of~     time and resources, without prejudice to the patients. However, the effectiveness of these~     simplified methods for patients with more complex medical conditions haven't been deeply~     explored.~      OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete~     dentures fabrication for patients with severely resorbed mandibular alveolar bones.~      METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a~     university clinic will be rehabilitated following a simplified technical proposal, being~     divided randomly into two groups according to the mandibular arch molding technique. In~     group A, a single impression with alginate through pre-fabricated trays will be performed,~     while patients allocated in group B will receive a second molding with a more complex~     technique. After 3 and 6 months, besides important clinical parameters, it will be~     investigated aspects related to patient's perceptions about the success of treatment. The~     study will be conducted with a minimum of 30 participants per group, and comparisons between~     the two groups will be made by means of tests suitable for distribution of data.~   "
54848|NCT02339168|"~     This phase I trial studies the side effects and best dose of metformin hydrochloride when~     given together with enzalutamide in treating patients with prostate cancer that has not~     responded to previous treatment with hormones. Hormone therapy using enzalutamide may fight~     prostate cancer by lowering the amount of androgens the body makes and blocking the use of~     androgens by the tumor cells. Metformin hydrochloride, used for diabetes, may also help kill~     tumor cells. Giving enzalutamide together with metformin hydrochloride may kill more tumor~     cells.~   "
54849|NCT02339155|"~     This study, as a post-marketing commitment to the Food and Drug Administration, is designed~     to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a~     healthy volunteer population. This is a randomized, open-label, parallel group, two arm~     study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is~     administered alone or concomitantly with raxibacumab. The study is planned to enroll~     approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be~     approximately 26 weeks. The dates reflect cohort 1.~   "
54850|NCT02339142|"~     Thyroid eye disease is an autoimmune disorder affecting approximately 50% of individuals~     with autoimmune thyroid diseases resulting in enlargement of ocular muscles and may lead to~     congestion of the eyelids and ocular surface, ocular movement restriction and double vision,~     and optic nerve compression and loss of vision.~      First line medical therapy is oral or intravenous corticosteroids (CS), which several~     studies have shown results in reduction of soft tissue congestion, but some studies~     suggesting that ocular restriction or visual loss may still occur in spite of CS therapy.i~      External beam radiotherapy (XRT) is second line therapy but is controversial, with some~     studies suggesting benefit in preventing onset of double vision or optic nerve compression~     while other studies suggest it has no benefit. Most proponents of XRT for TED believe that~     it is most effective early in the disease evolution. XRT has been shown to be a safe therapy~     with few side-effects, although retinopathy changes have developed in a small percentage of~     diabetics and its use is avoided for diabetics.~      Combined oral prednisone and XRT has been shown to be more effective in reducing soft tissue~     inflammation and motility complications than either monotherapy in two different studies.~      To date there have been no trials comparing combined XRT and iv CS with iv CS alone for~     early progressive TED to identify potential benefit in reducing the severity of motility~     disorders or preventing the onset of dysthyroid optic neuropathy. That is the purpose of~     this study.~   "
54851|NCT02339129|"~     This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled,~     parallel-group study designed to determine the dosing interval, efficacy and safety of~     SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for~     the treatment of pain associated with DOMS.~   "
54961|NCT02337699|"~     25-SMI-2014 is a post market observational, questionnaire based study to assess the~     effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin~     pain. Within is also a nested feasibility study to assess the clinical utility of a~     Quantitive Sensory Testing (QST) protocol in the management of the described study group.~   "
54962|NCT02337686|"~     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to~     control glioblastoma. The safety of this drug will also be studied.~   "
54852|NCT02339116|"~     Bev improves the efficacy of first-line chemotherapy in unresectable mCRC. In the phase III~     TRIBE trial upfront FOLFOXIRI plus bev provided a significant advantage in terms of PFS and~     RR compared to FOLFIRI plus bev. A trend toward better OS was also evidenced. The~     second-line treatment was at investigator's choice. A manageable increase in diarrhea,~     mucositis and neutropenia was reported, while no differences in febrile neutropenia, serious~     adverse events and toxic deaths were evidenced.~      A growing amount of data support the clinical relevance of achieving an early and deep tumor~     shrinkage.~      Phase III TML and BEBYP trials demonstrated that the continuation of bev beyond disease~     progression combined with a switched chemotherapy regimen provided a significant advantage~     in terms of OS and PFS.~      Based on recent evidences, the partial interruption of the upfront induction chemotherapy~     before disease progression and the prosecution of bev until disease progression as~     maintenance treatment is a valid strategy in the treatment of mCRC.~      On the basis of these considerations, a first-line doublet plus bev followed by a~     second-line switched doublet (from oxaliplatin to irinotecan and viceversa) plus bev should~     be considered a standard option for mCRC patients. Only retrospectively collected data are~     currently available about the efficacy of first-line FOLFOXIRI plus bev followed by~     second-line rechallenge with FOLFOXIRI plus bev. We therefore designed the present phase III~     randomized trial of first-line FOLFOXIRI plus bev followed by reintroduction of FOLFOXIRI~     plus bev at progression versus FOLFOX plus bev followed by FOLFIRI plus bev at progression~     in first- and second-line treatment of unresectable mCRC patients.~   "
54853|NCT02339103|"~     The purpose of this study is to compare two novel active rewarming techniques in mildly~     hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14~     degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids~     (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize~     that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will~     prove to provide significantly superior rewarming rates than shivering alone.~   "
54854|NCT02339090|"~     The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of~     treatment effect against daily injections of rhGH.~   "
54855|NCT02339077|"~     This is a descriptive study to determine the role of fetal GBS disease as a cause for~     stillbirths~   "
54856|NCT02339064|"~     This is a Phase 3, multicenter, open-label, safety and efficacy study of continuous infusion~     apomorphine in subjects with advanced Parkinson's Disease (PD) who are unable to achieve~     adequate control despite optimized noninvasive therapy.~   "
54857|NCT02339051|"~     Osteoporosis is a large public health disease, characterized by low bone mass and micro~     architectural deterioration of bone tissue, resulting in enhanced bone fragility and~     consequent increase in fracture risk. Osteoporosis is present when bone mineral density~     (BMD) or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5~     SDs below the mean value of the young adult. BMD measured by DXA is a surrogate measure of~     bone strength and is the primary determinant of fracture risk in both men and women.~     However, the majority of fragility fractures occur in women and in individuals who do not~     have osteoporosis according to these standards, indicating that BMD is just one among~     several indicators of bone health and that assessment of fracture risk should also rely on~     other bone properties. Newer imaging methods, such as quantitative computerized tomography~     (QCT), can complement information from DXA-measurements due to its ability to assess~     volumetric BMD and bone geometry and to differentiate between cortical and trabecular bone~     compartments. Bones are composite materials made predominantly of living cells,~     extracellular matrix, water and lipids. This composite nature of the bone material enables~     it to absorb stresses by elastic deformation and to endure high loads before fracturing. A~     new in vivo measurements of bone material strength can be used to evaluate bone mechanical~     properties and thereby the fracture risk. It is well established that the skeleton benefits,~     in terms of increased density, from regular physical activity. However, changes in BMD are~     still the main surrogate for assessing improvements in exercise-induced bone health despite~     the experimental findings as well as findings in humans showing that improvements in~     mechanical bone properties are independent of changes in BMD. These improvements in~     mechanical bone properties may be due to changes in bone shape or matrix composition. It~     could then be argued that a decrease in BMD is only one of the possible manifestations of~     osteoporosis and that bone strength or fragility is multifactorial. The objective for this~     study is to investigate the role of mechanical loading on bone material strength and bone~     microarchitecture in middle-aged women. The overall hypothesis is that mechanical loading is~     a regulator of bone material strength and microarchitecture in middle-aged women. This is an~     intervention study where the participants will act as their own controls. The investigators~     intend to include 40 postmenopausal and healthy women 50-60 years of age in the study.~     Advertisements in local papers and at the hospital will be used to come into contact with~     suitable study subjects. The women will be asked to perform an intervention program,~     including jumping on one leg every day during a 3-month period according to a protocol with~     a gradually increasing load/number of jumps. The women have to choose one of their legs as~     intervention-leg and stick to the chosen leg throughout the study. The leg without~     intervention will be used as a control. Both bone material strength (BMS) and bone~     microarchitecture will be measured before and after intervention in both legs (tibia). The~     operators measuring BMS (OsteoProbe®) and bone microarchitecture (high resolution pQCT) will~     be blinded concerning each participant's choice of leg for intervention. In addition,~     subjects will be asked to register daily physical activity in a structured diary. The~     primary outcome measure will be changes in bone material strength (BMS) in the lower leg~     (tibia) with intervention compared to the leg (tibia) without intervention. Participants~     will attend two clinic visits, at baseline and after 3 months when the intervention period~     is completed. The secondary outcome measures will be changes in total volumetric density,~     cortical volumetric density, cortical cross sectional area and trabecular bone volume~     fraction in the lower leg (tibia) with intervention compared to the leg (tibia) without~     intervention.~   "
54858|NCT02339038|"~     Background:~      - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes~     from a combination of medicines that is yielding high cure rates. But its long-term effects~     are uncertain. One problem is that a lot of people need the treatment, but only a few~     specialists can give it. The success rate for Hepatitis C treatment by primary care doctors,~     nurse practitioners, or physician assistants is largely unknown. Researchers want to see how~     provider type affects treatment outcomes. They will conduct a large, community-based study~     in the District of Columbia.~      Objectives:~      - To see if people can be treated for Hepatitis C safely and successfully in community-based~     health centers.~      Eligibility:~      - Adults who need treatment for chronic Hepatitis C infection.~      Design:~        -  Participants will be screened with blood tests. Their current medicines will be~          reviewed.~        -  Participants will give researchers access to their medical records. Researchers will~          follow participants through these records.~        -  Participants will see a primary care or infectious disease provider. The provider will~          tell them about their treatment. They will be told how often they will visit the~          provider and how often they will have their blood drawn. They will get a calendar of~          study visits.~        -  Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care~          provider monthly.~        -  Participants will have monthly follow-up visits for up to 3 months after they finish~          their medicine.~        -  Participants will have yearly follow-up visits with their care provider for up to 10~          years.~   "
54859|NCT02339025|"~     Background:~      - Researchers at the National Cancer Institute and the Department of Defense are trying to~     learn more about what causes cancer, heart disease, and other health problems. To do this,~     they gather data on risk factors and biological markers. They get these data from large~     groups of people in long-running studies. As these groups of people age, researchers must~     form new groups. TRICARE is a health insurance program for uniformed service members and~     their families. It is a major part of the Military Health System. Researchers hope to form a~     new study group from TRICARE members. This study will test if TRICARE members will take part~     in a research study.~      Objectives:~      - To test if TRICARE members will take part in a research study.~      Eligibility:~      - TRICARE members aged 35 74 with military primary care providers at Walter Reed National~     Military Medical Center. They must not have a prior diagnosis of cancer other than~     non-melanoma skin cancer.~      Design:~        -  Participants will fill out a survey. It will ask about their risk factors for cancer~          and other chronic diseases. Their medical records will be reviewed. They will give a~          blood sample.~        -  If a larger study is formed, then participants data will be used in the larger study.~          They may be asked to give more samples.~   "
54866|NCT02338934|"~     This is a single arm, open-labelled study to determine the effectiveness of combination~     Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in~     patients with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD +~     PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per~     week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH~     has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below~     2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will~     be decreased.~      Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and~     Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit~     normal at 6, 12 and 24 months will be determined~   "
54867|NCT02338921|"~     To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in~     type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of~     two drug combination therapy with glimepiride and metformin.~   "
54860|NCT02339012|"~     Background:~      - Biomarkers are substances in people s blood and tissues. They help researchers understand~     diseases and signs of aging. Scientists want to do more research on biomarkers to find ways~     to improve quality of life in old age.~      Objective:~      - To learn more about biomarkers and their relationship to aging.~      Eligibility:~      - Adults at least 20 years old who weigh at least 110 pounds and have a body mass index~     below 30. They must agree that their genetic samples can be collected, studied, and stored.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have heart tests and nurse will assess their veins. They will fill out~          a questionnaire.~        -  Participants will have a 2-day baseline visit. Then they will return every 2 years for~          up to 10 years. These follow-up visits will repeat the baseline visit:~        -  Repeat of screening procedures.~        -  Physical performance tests like balance and walking tests.~        -  Leg and grip strength tests.~        -  Health and mental state questions.~        -  Memory and problem solving tests.~        -  Cytapheresis. Blood will be removed through a needle in the vein of one arm and run~          through a machine. The blood will be returned through a needle in a vein of the other~          arm.~        -  Visits may also include:~        -  Magnetic resonance imaging scans. Participants will lie on a table that slides in and~          out of a machine that takes pictures.~        -  Diabetes test. After fasting, participants will drink a sweet drink and give blood.~        -  Breathing and walking tests.~        -  Wearing a device that record physical activity.~        -  Scan of the abdomen and the right leg.~        -  A small amount of muscle tissue and/or skin removed.~   "
54861|NCT02338999|"~     Background:~      - Lupus causes a person s immune system to attack the body. It can cause blood vessel~     problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may~     help.~      Objectives:~      - To see how well pioglitazone improves blood vessel function and decreases blood vessel~     inflammation. To study its effect on lupus symptoms.~      Eligibility:~      - Adults at least 18 years old with lupus.~      Design:~        -  Participants will be screened with medical history, heart test, and blood and urine~          tests. They may have a bone density test.~        -  Visit 1:~        -  Participants will have:~        -  Physical exam and blood drawn.~        -  Peripheral Arterial Tonometry (Endopat). A cup will be placed on the finger and a~          pressure cuff on the arm.~        -  Cardio-ankle vascular index (CAVI) and/or Sphygmocor. Electrodes will be placed on both~          wrists, a microphone on the chest, and a blood pressure cuff on each arm and leg.~          Another test will involve placing a small device on a fingertip.~        -  18-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography~          (PET/CT) (some participants). A radioactive sugar will be injected into a small plastic~          tube in an arm vein. Participants will lie on a bed that moves in and out of a scanner~          that takes pictures.~        -  Participants will get a 3-month-supply of the study drug or placebo. After 1 week,~          their dose may increase.~        -  After those 3 months, they will not take either drug for 8 weeks. Then they will switch~          and take the other drug for 3 months.~        -  Participants will have 6 more visits over 8 months after Visit 1. Tests from Visit 1~          may be repeated. They may have a urine test.~   "
54862|NCT02338986|"~     Background:~      - There are more emerging infectious diseases recently. Some could affect many people. Some~     like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are~     caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola.~     Many of these diseases don t have good treatments available. Researchers may be able to~     develop a treatment by using antibodies against these infections.~      Objective:~      - To collect antibodies from people with high levels of antibodies to the diseases being~     studied.~      Eligibility:~      - Healthy men 18-70 years old who weigh at least 110 pounds. They may have been infected~     with or vaccinated for one of the new infections researchers are studying.~      Design:~        -  Participants will be screened with medical history and blood tests. Researchers will~          determine if the participant can have apheresis.~        -  Participants will have apheresis. First, they will be interviewed. Then, a needle will~          be placed in a vein. Blood will be drawn, and a machine will separate the blood cells~          from the antibodies and protein. The blood cells will then be returned to the~          participant through another vein. It takes about 60 minutes for the actual collection.~        -  Participants will be asked to have the procedure at least 3 times. They can participate~          in up to 20 sessions total as part of this study. There must be at least 7 days between~          sessions.~   "
54863|NCT02338973|"~     Background:~      - People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid~     under the retina of their eye. This can cause vision loss. The medicine interferon gamma-1b~     may help people with these diseases.~      Objectives:~      - To see if interferon gamma-1b eyedrops are safe for people with RCD or ESCS. To see if the~     medicine can decrease retina fluid and help prevent vision loss.~      Eligibility:~      - People at least 12 years old with RCD or ESCS. Those with ESCS must have two mutations in~     the NR2E3 gene.~      Design:~        -  Participants will be screened with medical history, physical exam, eye exam, and blood~          tests.~        -  Participants will stay at NIH for 2 days and get the first eyedrops.~        -  Participants will give themselves 4 study eyedrops 4 times daily for 2 weeks and keep a~          diary.~        -  Participants will have 2 phone calls and 5 outpatient visits over 8 weeks. They may~          have:~        -  Repeats of screening tests.~        -  Questionnaires.~        -  Small piece of skin removed.~        -  Eye exams, including eye dilation and tasks on computer screens.~        -  Fluorescein angiography. A dye injected into an arm vein will travel to the blood~          vessels in the eyes. A camera will take pictures.~        -  Electroretinography. Participants will sit in the dark wearing eyepatches. A small~          electrode will be taped to the forehead. After 30 minutes, researchers will remove the~          eyepatches and put in numbing eyedrops and contact lenses. Participants will watch~          flashing lights.~        -  Electrooculography. Electrodes will be attached outside of the eyes and eye function~          will be measured in the dark and the light.~        -  Participants will have a follow-up visit after 52 weeks.~   "
54864|NCT02338960|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an~     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered~     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without~     decreased arousal) in premenopausal females.~   "
93910|NCT01827917|"~     The objective of this study was to achieve the post-marketing protective effect research of~     Speeda® rabies vaccine for human use from Chengda Bio.~   "
54869|NCT02338895|"~     Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an~     intensive care unit and is a strong predictor of mortality.Therefore any management strategy~     that prevents progression of renal risk to injury or failure has the potential to improve~     outcomes in these patients.Conventional management of acute oliguria in shock has been to~     blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid~     loading has been considered as accomplished. However both volume overload and 'blind'~     attempts at fluid removal can worsen renal injury and have been associated with higher~     mortality by venous overcongestion and inappropriate hypovolemia. It seems reasonable to~     assume that a bedside test to visualize volume status and renal perfusion may assist in~     improving outcomes in this cohort.The investigators developed a goal-directed~     ultrasonographic protocol to provide immediate hemodynamic information in acutely oliguric~     patients with shock as well as a management algorithm for guiding therapy. The investigators~     incorporated IVC diameter measurement, respiratory variation and response to a passive leg~     raise to assess whether further fluid boluses were required and a measurement of renal~     perfusion to determine whether diuretics or renal replacement therapy were indicated. The~     investigators aim to measure the effects of this management protocol on the rates of AKI in~     the study participants as compared to prior to the implementation of the protocol.The study~     design is a prospective, observational. Since this is a proof of concept study, the~     projected sample size is 40 patients. An interim analysis will be carried out after 20~     patients are enrolled and a further 20 will be enrolled as necessary~   "
54870|NCT02338882|"~     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses~     are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs~     are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles~     for viewing near objects. This study has been designed to look at how well a multifocal IOL~     corrects distance and near vision in comparison with a conventional monofocal IOL. Both~     types of IOLs are commercially available and are commonly implanted. Using new non-invasive~     methods we hope to be able to better judge the visual performance of these IOLs. In addition~     the study will involve imaging and examining the IOLs to determine the prevalence of any~     post-operative complications.~   "
54871|NCT02338869|"~     Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based~     psychosocial intervention for stroke acute survivors in primary care one to six months~     poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28~     (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into~     intervention group or control group. Patients are followed up for 12 months.~   "
54872|NCT02338856|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after~     multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after~     multiple dose.~   "
54873|NCT02338843|"~     This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult~     patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple~     centers globally.~   "
54874|NCT02338830|"~     To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in~     asymptomatic twin pregnancies who have sonographic short cervix~   "
54875|NCT02338817|"~     Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia,~     putting them at risk for several complications, such as hepatomegaly, adenomas, and~     cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick~     glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive~     hypoglycemia detector designed like a watch, has been available for diabetic patients to~     non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The~     investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types~     0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as~     whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD~     patients in managing hypoglycemia, both clinically and at home.~   "
54876|NCT02338804|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
54877|NCT02338791|"~     The purpose of this study is to measure the amount of movement between the bones of the~     shoulder joint when mobilization techniques are applied by a physical therapist.~   "
54878|NCT02338778|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
54879|NCT02338765|"~     The purpose of the 12-week study is to determine if competing a physical activity program~     with a buddy helps increase daily physical activity when compared to completing the same~     physical activity program without a buddy.~   "
54880|NCT02338752|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
54893|NCT02338583|"~     This prospective, single-arm multi-center study will provide clinical data in an~     observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler~     Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS~     lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals~     undergoing VATS diagnostic wedge resection in accordance with their institution's Standard~     of care (SOC), and who meet study entry criteria, may be enrolled.~      Study procedures will include a wedge resection, wedge resection followed by lobectomy of~     the same lobe, or lobectomy.~   "
54894|NCT02338570|"~     Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer~     in treatment with everolimus and previously treated with a Vascular endothelial growth~     factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)~   "
57800|NCT02300571|"~     This observational study is proposed to observe the effect of high-dose,~     post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an~     HLA-identical or mismatched donor.~   "
54881|NCT02338739|"~     Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment~     often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A~     strategy to optimize retention within resource constraints is urgently needed. Sequential~     adaptive strategies - a novel class of public health approaches - may offer a solution. A~     candidate sequential adaptive strategy would start with a less expensive intervention (e.g.,~     SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only~     to patients who show early signs of poor retention. This study involves a sequential~     multiple assignment randomized trial to evaluate a family of such strategies. the~     investigators will randomize 2,500 adults newly initiating antiretroviral treatment (ART) at~     4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and~     counselling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early~     signs of weakening retention (defined as the first time a patient is 14 days late for an~     appointment) will be re-randomized to (1) a single episode of outreach (standard of care),~     (2) SMS combined with vouchers, or (3) a peer navigator. Patients not successfully contacted~     by 28 days after missed visit (and not verified to have left the area or transferred to~     another clinic) will also be rerandomized to of one the same three re-engagement~     interventions. Individuals randomized at first stage to SMS or voucher that do not miss a~     visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12~     months to stop first stage intervention or continue with that same intervention to 24~     months. The investigators primary objective is to assess the comparative effectiveness of~     sequenced intervention strategies to prevent initial lapses in retention and to treat those~     that occur. The investigators primary endpoint is alive and virologically suppressed two~     years after enrolment. In addition, the investigators will assess the comparative~     effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention,~     and the comparative effectiveness of second stage strategies (outreach, SMS + voucher,~     navigator) to re-engage patients after initial lapse. This study will also compare outcomes~     among patients who continue versus discontinue the SMS and voucher interventions, including~     a small complementarity component utilizing qualitative methods to examine the voucher~     approach and the effects of discontinuing this approach after success among a subset of~     participants. At study conclusion the investigators output will be a menu of adaptive~     strategies for retention, accompanied by estimates of cost and effectiveness, which policy~     makers in different settings can use to advance the impact of HIV care and treatment~     programs in Africa.~   "
54882|NCT02338726|"~     To assess pelvic floor symptoms and quality of life in elderly women.~   "
54883|NCT02338713|"~     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a~     novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 mg and vitamin~     D3 1000 IU) increases the amount of calcium excreted in urine and decreases parathyroid~     hormone (PTH) in serum as compared with Baseline.~   "
54884|NCT02338700|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
54885|NCT02338687|"~     The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is~     the effectiveness of low-dose (500 mg/day) calcium supplements associated with an~     educational intervention, compared to the educational intervention alone, in the prevention~     of preeclampsia and hypertensive disorders during pregnancy.~   "
54886|NCT02338674|"~     Chronic hepatitis B patients with normal ALT are not subjective to the therapeutic~     indication in EASL Clinical Practice Guidelines. However, growing consensus on long-term~     risk of HBV infection with normal ALT are reached as more solid evidences are accumulated.~     Moreover, a large proportion of hepatitis B patients with normal ALT are at child-bearing~     age. Concerns about the impact of HBV on fetal and neonatal health become a psychological~     burden for them.~      Therefore, it is necessary to explore a regimen that can generate a rapid virological~     response, and a promising e antigen conversion rate, and safeguard the fetus.~      The pre-clinical study at our center found that the group had a rapid decrease of HBV DNA~     and a low recurrence rate after discontinuation of antiviral therapy with combined tenofovir~     and telbivudine (LdT + TDF) treatment.~      The current study is to use tenofovir and telbivudine jointly in immune-tolerant patients~     with chronic hepatitis B, and observe seroconversion rates, DNA decrease, the proportion of~     drug resistance, and relapse rate after treatment, as well as adverse effects.~   "
54887|NCT02338661|"~     This study is a prospective, single-center, postmarket clinical observation to observe the~     clinical and radiographic long-term performance of the SBG hip stem.~   "
54888|NCT02338648|"~     The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as~     compared with placebo TDS in the treatment of chalazion based on the proportion of subjects~     that have complete response. Complete response is defined as the absence of any significant~     clinical signs of a chalazion with possible scaring or skin defects resulting from healing~     of the chalazion allowed.~   "
54889|NCT02338635|"~     Peritoneal fibrosis is one of the major causes of technical failure in patients on~     peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of~     peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER)~     stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA)~     is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis~     in the investigators in-vitro study. In this study the researchers investigated the~     hypothesis that URSA protect peritoneal membrane damage.~   "
54890|NCT02338622|"~     This is a phase I trial of the combination of the PARP inhibitor olaparib and AKT inhibitor~     AZD5363.~      There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.~      Part A will investigate the combination of 300 mg bd of olaparib with intrapatient ascending~     doses of AZD5363 administered for either 4-days-on, 3-days-off, and 2-days-on, 5-days-off.~      Once the Maximum Tolerated Dose (MTD) is reached for both arms (or under the advice from the~     Safety Review Committee (SRC) one of the schedules will be discontinued), the schedule with~     the optimum safety and PK/PD profile will be taken forward to a dose expansion phase (Part~     B).~      Part B will evaluate the optimized dose/schedule identified in Part A of the study in~     patients with (1) BRCA1/2 mutant cancers (with previous disease progression on PARP~     inhibitor monotherapy), or (2) advanced sporadic tumours (e.g. TNBC, CRPC, HGSOC and tumours~     with somatic mutations or other aberrations known to result in a hyperactivated PI3K-AKT~     pathway).~   "
54891|NCT02338609|"~     The primary objective of CRAD001M2305 is to report the long-term effects of everolimus~     treatment on height, weight and sexual development (using Tanner Stages) in children and~     adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell~     Astrocytoma (SEGA). The study will monitor the growth and development of pediatric patients~     with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they reach Tanner Stage~     V, or until age 16 for females or 17 for males whichever occurs first.~   "
54920|NCT02338232|"~     This is single-center, open-label, prospective study of telmisartan for the prevention of~     acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a~     hematologic malignancy.~   "
54895|NCT02338557|"~     Study was conducted Effectiveness of Motor Relearning Programme and Mirror Therapy along~     with Conventional Physiotherapy treatment for improving Hand Function In Patients with~     stroke. study was an experimental study conducted on 12 stroke patients using convenient~     sampling method .Subjects were divided into two equal groups (n=6). Group A was given~     conventional physiotherapy and Motor Relearning Programme exercises for the affected hand~     and Group B received conventional physiotherapy for the affected hand and mirror therapy for~     the unaffected hand. Chedoke arm and hand inventory (CAHAI) was used as primary outcome~     measure for evaluation of hand function before and after application of therapeutic~     Intervention~   "
54896|NCT02338544|"~     The purpose of this observational trial is to assess application and convenience of Epiduo®~     PUMP under daily clinical practice conditions in patients with moderate to severe~     inflammatory acne.~   "
54897|NCT02338531|"~     This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic~     triple-negative breast cancer patients with residual disease (cHEmoresistant) after~     completion of standard neoadjuvant chemotherapy.~   "
54898|NCT02338518|"~     Chemotherapy is an important therapeutic method for unresectable gastric cancer patients.~     However, there is currently no established standard chemotherapeutic regimen for gastric~     cancer. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX~     regimens. The investigators estimate that combined intravenous and intra-arterial~     intensified SEEOX neoadjuvant chemotherapy may be a safe and promising regimen in~     unresectable gastric cancer patients.~   "
54899|NCT02338505|"~     Phase II prospective single-institutional study.~   "
54900|NCT02338492|"~     The purpose of this study is to collect safety and performance data of the Photodynamic Bone~     Stabilization System (PBSS) when used for the treatment of painful impending and actual~     fractures of the humerus secondary to metastatic cancer.~   "
54901|NCT02338479|"~     This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric~     HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood~     and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow~     Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource~     for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The~     study will enroll pediatric patients who undergo myeloablative HCT for hematologic~     malignancies at PBMTC sites.~   "
54902|NCT02338466|"~     Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke.~     Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective~     treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to~     50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by~     rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no~     recanalization after rt-PA. A case series of 13 consecutive patients treated by this~     association has been published in 2011. A high rate of recanalization without hemorrhagic~     transformation increase has been reported. However, efficiency and safety of this~     therapeutic have to be assessed in a randomized multi-centric study. Such a study is of~     great interest since interventional neuroradiology has not already shown superiority~     regarding IV rt-PA. Moreover interventional neuroradiologists specialists are only available~     in major hospital and an IV sequential strategy could provide an interesting alternative.~      Main study objectives:~      Main Clinical Objective:~      Sequential thrombolysis should be associated with a significant better outcome at 3-month,~     assessed by the modified Rankin score (mRS).~      Main Radiological Objective:~      Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI~     2b/3) at 24-hour.~   "
54903|NCT02338453|"~     This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an~     augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in~     adults. It is expected that ABMT vs. control training condition would achieve better~     therapeutic outcomes as indicated reduction in symptoms.~   "
54904|NCT02338440|"~     Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains~     the major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up~     to 50%.~      Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by~     Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1~     and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts~     comparable effects by 1/4~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt~     lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by~     Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with~     preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).~   "
54905|NCT02338427|"~     Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid~     proteins involved in the formation of abnormal tissue deposits. There are approximately 30~     proteins involved in amylose's constitution. The therapeutic management varies depending on~     the type of amyloidosis observed.~      The application of conventional techniques immunolabeling of amylose does not allow the~     comprehensive characterization of amylose forms, due to failures of the technic, the false~     positivity of some results, or lack of frozen tissue available for typing light chain~     (lambda, kappa).~      In this study, the main objective is the comparison of two capacity of amylose~     characterisation: immunohistochemistry and proteomics analysis.~      The purpose of this study is to validate the superiority of proteomic analysis by~     demonstrating the improvement of the precision, the reduction of technical failure, as well~     as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.~   "
54906|NCT02338414|"~     The aim of this study is to evaluate the efficacy of romiplostim administered at every other~     week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive~     weeks after weekly doses of romiplostim.~   "
54921|NCT02338219|"~     The purpose of this study is t o evaluate levator ani morphology following normal vaginal~     delivery and cesarean section (elective and emergent), using three-dimensional (3D)~     ultrasound, and to study the effect of mode of delivery on female sexual function.~   "
54922|NCT02338206|"~     The long down regulation protocol is widely used in the in vitro fertilization cycles, now~     it will be assessed regarding its efficacy, in poor responder females undergoing in vitro~     fertilization cycles, alone and after the addition of growth hormone.~   "
54907|NCT02338401|"~     Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This~     reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy~     expenditure of tissues (Manini 2010).~      It has also been shown that as we age there is a:~        -  Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the~          decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and~          Gallagher 2010).~        -  A change towards a more saturated membrane of different tissues (Rabini et al 2002).~      Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into~     cell membranes may alter energy metabolism by:~        -  Increasing the rate at which proteins operate (Hulbert 2007).~        -  Promoting the release of EPA and DHA into the cytosol which will act as ligands for~          peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an~          important role in energy homeostasis by regulating genes involved in lipid metabolism~          (Kota et al 2005).~        -  Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo~          et al 2014).~      Supplementation with fish oil in older males and females:~        -  Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).~        -  Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)~        -  Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM)~          accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to~          speculate that these changes may occur by some of the mechanisms described earlier,~          with skeletal muscle being an important contributor.~      To date there are no studies that have examined the effect of n-3 supplementation (3g/day)*~     on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible~     mechanisms behind it.~      Therefore the purpose of this study is to determine whether in older adults (female and~     male), supplementation with n-3 alters:~        1. RMR and fatty acid oxidation.~        2. Membrane composition of whole muscle and sarcolemma.~        3. Content of skeletal muscle membrane fatty acid transport proteins.~        4. Dose response of NaKATPase~        5. Content of mitochondrial proteins~        6. Expression and content of PPARs and proteins involved in translocation of FA~          transporters (AMPK, ERK1/2, CamKII).~        7. Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).~        8. Proteomic profile of skeletal muscle.~        9. Body composition~   "
54908|NCT02338388|"~     The aim of this trial is the surgical method in cesarean deliveries, especially the~     uterotomy closure technique.~   "
54909|NCT02338375|"~     The purpose of this study is to evaluate the safety and efficacy of adding allogenic~     umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment~     of arthroscopic curettage and microfracture for osteochondral lesion of talus.~   "
54910|NCT02338362|"~     The purpose of this study is to determine whether a commonly prescribed orally inhaled~     corticosteroid treatment will induce a clinically meaningful elevation in intraocular~     pressure, when administered to patients with ocular hypertension (OHT) or open-angle~     glaucoma (OAG). Based on the response to high-dose corticosteroids, this patient group is~     more likely than the normal population to demonstrate this adverse effect.~   "
54911|NCT02338349|"~     The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy~     of RAD1901 in patients with advanced ER+, HER2-negative breast cancer.~   "
54912|NCT02338336|"~     To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine~     therapeutic activity against Plantar Warts~        -  Clinical Tolerance~        -  Clinical Recovery~        -  Evaluate Safety~   "
54913|NCT02338323|"~     The purpose of this study is to determine whether febuxostat and benzbromarone could protect~     renal function, and which one could be better.~   "
54914|NCT02338310|"~     To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI)~     followed by standard adjuvant therapy improves outcome compared with standard adjuvant~     therapy alone in postmenopausal women with hormone receptor positive breast cancer.~      To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC)~     in the excised cancer around 2 weeks after starting AI therapy will predict for time to~     recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67~     value.~      To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts~     for long-term outcome in postmenopausal women with hormone receptor positive breast cancer~     better than at diagnosis.~   "
54915|NCT02338297|"~     Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients~     with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate~     portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in~     poor Lipiodol deposition in the tumor, causing liver ischemia.~      Occlusion of APS is a vital and initial step for the following embolization of tumor.~     Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with~     hepatocellular carcinoma (HCC).~      The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in~     the procedure of TACE, and to analyze the prognostic factors for survival in this kind of~     patients.~   "
54916|NCT02338284|"~     Patients admitted to the ICU may have delayed awakening after their critical illness has~     resolved. Though most either are due to metabolic causes or delayed elimination of sedative~     medications, more serious pathologies such as intracranial hemorrhage, ischemic stroke, and~     vasogenic edema may also be the cause of coma. These pathologies all result in increases in~     intracranial pressure (ICP) with cerebral edema. Identifying elevated intracranial pressure~     elevations have so far, relied on invasive monitoring techniques requiring placement of an~     intracranial or intraventricular catheter.~      The optic nerve sheath diameter (ONSD) has been described as a highly sensitive (88-94%) and~     specific (85% - 94%) noninvasive technique of identifying increased intracranial pressures~     in patients with brain trauma, intracranial bleeding or stroke[1-4]. This method requires~     placement of an ultrasound probe on the patient's closed eyelid and then a direct~     measurement of the diameter of the optic nerve sheath at a pre-specified distance from the~     globe. A value greater than 58 mm has been shown to correlate significantly with an~     increased ICP (> 20 cm H20); r = 0.71, p<0.001 [5].~      The investigators hypothesize that bedside ultrasound measurement of the ONSD is a simple~     screening test for increased intracranial pressure and can be used to rapidly and~     efficiently identify patients in the ICU who have coma due to an increase in intracranial~     pressure. The investigators propose to carry out an observational trial to determine the~     predictive ability of the Optic Nerve Sheath Diameter for cerebral edema/ increased~     intracranial pressure and to compare it with the results of neuroimaging (CT and/or MRI).~   "
54917|NCT02338271|"~     1. Subject: 10 patients~           : Chronic low back pain patients with lumbar intervertebral disc degeneration~        2. Investigational Product~           : Autologous adipose derived mesenchymal stem cells plus hyaluronic acid derivatives~          (Tissuefill)~        3. Time frame~             -  1 year~   "
54918|NCT02338258|"~     The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion~     of the long tubular bone after treatment of Intramedallery nailing~   "
54919|NCT02338245|"~     This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical~     activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination~     with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on~     prior trastuzumab therapy.~   "
54923|NCT02338193|"~     Women with a history of gestational diabetes (GDM) are at substantially increased risk of~     type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more~     likely to be overweight or obese. Moreover, weight gain after GDM is significantly~     associated with T2DM, independent of baseline body weight. Weight gain, particularly~     increased central adiposity after delivery, is strongly associated with deterioration of~     β-cell compensation for insulin resistance. Taken together, our findings and other studies~     support increased abdominal fat as the strongest factor associated with declining B-cell~     compensation for insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin~     is a novel highly selective SGLT2 inhibitor that improves glycemic control by reducing renal~     glucose reabsorption leading to urinary glucose excretion. Its efficacy and safety has been~     studied in multiple randomized controlled trials including an add-on to metformin compared~     with a placebo. To the extent that glucotoxicity contributes to the demise in β-cell~     function in subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the~     treatment of prediabetes. An additional secondary benefit of SGLT2 inhibition is the~     elimination of calories in the form of glucose. The loss of glucose with attendant caloric~     loss contributes to weight loss; in addition, improvements in β cell function have been~     seen. Weight loss seen with SGLT2 inhibitors is similar to that seen with glucagon-like~     peptide 1 analogs, and may be more acceptable because they are oral agents. A consistent~     finding in all dapagliflozin studies has been a reduction in blood pressure. The~     investigators hypothesize that combination dapagliflozin -metformin treatment over a 24-week~     period will have a greater positive impact on body weight, anthropometric measurements and~     glycemic and cardiometabolic parameters than dapagliflozin or metformin monotherapy in~     overweight/obese at-risk women with a history of GDM.~   "
54924|NCT02338180|"~     It is of clinical importance to arrest the development of approximal caries at an early~     stage. The potential for initial caries to develop into manifest lesions has motivated~     studies on the use of sealants to arrest the progression of caries on both occlusal and~     approximal tooth surfaces.~      Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the~     efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars~     abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested~     here was that preventive and therapeutic sealants do not prevent the development or slow the~     progression of dental caries over a period of 3.5 years in comparison to non-sealed control~     surfaces.~   "
54925|NCT02338167|"~     Among patients with breast cancer the subgroup of patients with metastases are considered~     the group of patients with the worst prognosis. Not only with regard to therapy decisions~     but also with regard to quality assured healthcare and health economics this entity of~     patients remains a challenge.~      Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor~     entities and identification of patients, for whom the greatest therapy benefit and the least~     side effects are expected.~      However molecular assessment of the patient and the tumor in the metastatic situation is not~     performed on a routine basis and in many cases tumor characteristics from the primary tumor~     are considered reliable enough to make therapy decisions for the metastatic patients.~     Although molecular reassessment of tumor characteristics from tumor material of the~     metastasis is recommended in national guidelines, only a minority of patients is biopsied,~     because of the invasiveness of the procedure, even though biopsy related complications are~     reported to be rare.~      With modern analytic methods from blood based biomaterial there seems to be an opportunity~     to correlate blood based tumor assessments with actual characteristics of the tumor. These~     include expression analysis, tumor mutation analysis, tumor gene copy number abberations and~     others. One of the main aims of the PRAEGNANT study is therefore to establish an~     infrastructure for the comprehensive analysis of tumor and metastatic molecular~     characteristics of the patient and the tumor.~      Furthermore the impact of health care related outcomes such as health economics novel~     approaches for integration of patients in study conduct and health care awareness are study~     aims of the PRAEGNANT study.~   "
54926|NCT02338154|"~     The purpose of this active post-market surveillance study is to confirm the safety and~     effectiveness of the EDWARDS INTUITY Valve System in the study population.~      The objective is to evaluate cardiac performance characteristics and adverse events rates~     associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical~     approach is either full or partial sternotomy or a right anterior thoracotomy.~   "
54927|NCT02338141|"~     This study will evaluate the effectiveness of portable colposcopy when compared to~     conventional colposcopy (25x magnification of the cervix, the gold standard) and~     Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted~     low-resource method). Half the participants will be evaluated for cervical pathology by~     portable colposcopy after VIA assessment, while the other half will be evaluated by~     conventional colposcopy. This study also will use collected lab specimens for human~     papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among~     higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus~     (HIV)-positive women.~   "
54928|NCT02338128|"~     The purpose of this study is to determine whether Febuxostat could protect cardiovascular~     function of peritoneal dialysis patients by lowering serum uric acid.~   "
54929|NCT02338115|"~     The purpose of this prospective observational study is to understand the relationship~     between paclitaxel exposure and development of peripheral neuropathy during treatment.~   "
54930|NCT02338102|"~     The purpose of this study is to learn whether nasal saline irrigation is beneficial to~     patients undergoing radiation therapy for oropharyngeal cancer.~   "
54931|NCT02338089|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle (myometrium) tone after delivery. The~     first line agent used in the prevention and treatment of PPH is oxytocin.~      Women who require augmentation of labor with intravenous oxytocin because of inadequate~     labor progression have been shown to be at increased risk of PPH. Typically, for~     augmentation of labor, oxytocin is used as a continuous infusion, with no consensus on the~     initial dose, its increments or maximal limit. High concentration continuous oxytocin~     infusions are not without theirs risks, which include hyperstimulation, fetal distress, as~     well as uterine rupture.~      Studies have shown the clinical benefits of pulsatile oxytocin delivery for labor induction~     and augmentation with regards to requirement of less total oxytocin, similar uterine~     contractility and similar rates of caesarean delivery when used for labor induction and~     augmentation. However, the rate of PPH as a primary outcome measure has not been~     investigated. Therefore we currently do not know the effect of pulsatile oxytocin delivery~     on the rate of PPH.~      The investigators hypothesize that the effect of myometrial desensitization following~     pulsatile oxytocin exposure would be lower when compared to continuous oxytocin exposure.~     These results will help in establishing whether myometrial contractility and sensitivity to~     oxytocin can be better preserved by delivery of pulsatile oxytocin, rather than continuous~     oxytocin for labor induction and augmentation, and thereby result in less PPH.~   "
54932|NCT02338076|"~     Petrolatum is a very well-known emollient that has been used since the 1800's. Not only has~     it been used to help with dry skin, but it is also marketed as a substance that protects~     minor cuts and burns. In the past it was thought to be inferior to topical antibiotics in~     infection prevention for cutaneous wounds. However, in 1996 a large, multicenter trial~     including over 900 patients showed that petrolatum is as safe and effective as the topical~     antibiotic, bacitracin in preventing infections for patients undergoing dermatological~     surgery. In this trial, not only did the petrolatum group have similarly low rates of~     infection, this group also reported no cases of contact dermatitis. Aside from being more~     expensive than petrolatum, bacitracin and other topical antimicrobials (i.e. neomycin) have~     been known as common culprits of contact dermatitis. In a study done by the North American~     Contact Dermatitis Group between 2005-2006, 9.2 and 10% of the over 4,000 patients who were~     patch tested had an allergic reaction to either bacitracin or neomycin, respectively. For~     the above reasons, it is clear that petrolatum is an appealing alternative to topical~     antibiotics for infection prevention in patients undergoing dermatological procedures. This~     study however lacked any mechanistic analyses to provide molecular insight as to how~     petrolatum was effective at infection prevention.~      The aim of this research is to study the effect of petrolatum on innate immune reactions in~     the skin. In particular, petrolatum's effect on various antimicrobial peptides after contact~     with the skin for 3 days will be examined. This will be done through immunohistochemistry~     for various cellular infiltrates as well as mRNA gene expression via RT-PCR analysis for~     inflammatory and AMP genes. Tissue samples of petrolatum occluded skin will be compared to~     both healthy skin and skin under occlusion alone as controls. These comparisons will isolate~     the effect of the petrolatum on the skin.~   "
54933|NCT02338063|"~     The purpose of this study is to determine whether immersive virtual reality technology is an~     effective intervention tool for HIV Prevention with adolescents.~   "
54934|NCT02338050|"~     This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity,~     safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic~     hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute~     Lymphoblastic Leukemia (ALL) who are in a morphologic complete remission and have~     pre-transplant minimal residual disease (MRD) > 0.01% (detected by flow cytometry). The~     primary objective of this study is to determine if treatment with moxetumomab pasudotox in~     the MRD positive setting is able to lead to MRD negativity (< 0.01% by flow cytometry) or at~     least a 1-log10 reduction in MRD prior to allogeneic HCT.~   "
54935|NCT02338037|"~     This pilot trial studies the brain concentration of eribulin mesylate in treating patients~     with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin~     mesylate, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Collecting small~     samples of brain fluids may help determine how well eribulin mesylate concentrates into the~     brain tumor.~   "
54936|NCT02338024|"~     This study proposes to assess whether a modified Antiretroviral Treatment Access Study~     intervention, proved to be effective in the U.S. and based on the nurse case management~     approach, can impact the enrollment in HIV care of recently detected HIV-positive patients~     in specialized health care clinics in three regions in Ukraine, using the existing local~     infrastructure. The proposed study addresses a significant public health issue of non-/late~     enrollment of HIV-positive persons in HIV care and treatment.~   "
54937|NCT02338011|"~     1. Compare the effect and safety of gefitinib alone with gefitinib plus concomitant~          WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR~          mutation with multiple BM.~        2. Verify the failure pattern of NSCLC patients harboring an EGFR mutation with multiple~          BM.~        3. Explore the rescuable therapy after progression of disease.~   "
54938|NCT02337998|"~     Purpose: Quantify the relationship between brachial plexus deformations caused by backpack~     carriage and upper extremity performance.~      Significance of expected results:~      The study will allow to quantify the effect of load carriage on both neural and vascular~     function parameters.~      Study plan The effect of nerve strain on neural function: based on the strains obtained for~     each load from computational simulation, and from animal studies published in the~     literature, the expected neural function, (e.g., motor and sensory) dysfunction will be~     estimated.~      Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a~     military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at~     baseline, following 45 min exposure, and following 15 min of recovery:~        1. Index finger microvascular flow will be measured by photoplethysmography (PPG).~        2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical~          stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein~          Monofilament (SWM) type.~        3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm,~          cold and warm sensation thresholds will be measured with a computerized quantitative~          thermal sensory device.~           Immediately following the 45 min loading exposure, the fine motor function of the index~          finger will be tested by the following procedures (in an unloaded condition):~        4. Index finger motor function; Force application profile during a trigger press will be~          measured using a force sensor located on a trigger of a dummy weapon simulator. Force~          application rate, peak force, and press-to-press peak force variability will be~          measured based on 10 trigger presses.~        5. Accuracy of force application; Will be evaluated by the simulated shot accuracy,~          horizontal displacement (X) and vertical displacement (Y).~        6. Subjective parameters; in all time points, the volunteers will be asked to rate their~          level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS~          affective) in the shoulders and other load bearing sites, as well as ratings of~          perceived exertion (RPE). All subjective parameters will be assessed using visual~          analogue scales.~   "
54939|NCT02337985|"~     This pilot clinical trial studies gene therapy following combination chemotherapy in~     treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin~     lymphoma. Placing genes that have been shown in the laboratory to inhibit the growth and~     spread of the immunodeficiency virus (HIV) into the patient's peripheral blood stem cells~     may improve the body's ability to fight HIV. Drugs used in chemotherapy work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving gene therapy after combination~     chemotherapy may improve the body's ability to fight HIV and AIDS-related non-Hodgkin~     lymphoma.~   "
54940|NCT02337972|"~     The aim of this study is to investigate the conjunctival bacterial flora and antibiotic~     resistance patterns following serial intravitreal injections of anti-VEGF in diabetic~     patients, using a povidone-iodine preparation without preinjection or postinjection topical~     antibiotics.~   "
54941|NCT02337959|"~     The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus~     3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the~     currently marketed Carestream DRX-1 Detector. The results of this study will be included in~     a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the~     US. The study was designed in accordance with the FDA Guidance titled Guidance for the~     Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on August 6, 1999.~   "
54942|NCT02337946|"~     The purpose of this study is to exploratorily examine efficacy and safety in the patients~     with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of KRAS~     wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 +~     panitumumab combination therapy and then assigned to two groups i.e., a group receiving~     5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab~     combination therapy.~   "
54943|NCT02337933|"~     The metabolic syndrome is characterized by the presence of overweight/obesity, insulin~     resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which~     together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus~     type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower~     ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.~      In the search for a pharmacological agent that can attend more components of the metabolic~     syndrome and above all improve insulin sensitivity to effectively prevent the development of~     CVD and DM2, ursolic acid is a promising compound.~      Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some~     fruits like apple peel, and plants such as rosemary. There is scientific evidence of~     important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of~     lipids and glucose, as well as on the body weight and metabolic parameters. However, the~     results are not clear and the mechanisms are not fully elucidados.~      The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity~     and metabolic syndrome.~   "
54944|NCT02337920|"~     Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need~     complementary stenting of revascularization procedures within the 2 years after the primary~     surgery because of a poor blood supply in their lower limb extremity. The Near infrared~     spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and~     provide information on the quality of the local oxygen supply. The aim of our observational~     study is to correlate the intraoperative NIRS variations at the calf and the soles and the~     one-year evolution of the arteritis.~   "
54945|NCT02337907|"~     The study is designed to compare the effects of BI 409306 compared to placebo in patients~     with cognitive impairment due to Alzheimer's Disease~   "
54946|NCT02337894|"~     The purpose of this study is to assess the effect of an eight-week dietary supplementation~     with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat~     oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body~     composition in obese pre-pubertal children.~   "
54947|NCT02337881|"~     The aim of this study is to assess whether or not the emergency tocolytic effect of combined~     nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms~     of inhibiting eminent preterm labor and improving perinatal outcomes.~   "
54948|NCT02337868|"~     This trial will be a randomized, placebo controlled, double-blind (within dosing group),~     dose escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV~     vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50~     years of age. The primary objective is to assess the safety, reactogenicity, and~     tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose~     series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.~   "
54949|NCT02337855|"~     This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study~     will recruit 72 healthy adult males and non-pregnant females from a single clinical center~     to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using~     Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary~     objective is to assess the safety and reactogenicity of ascending doses of~     Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three~     doses administered on Days 1, 57, and 113.~   "
54950|NCT02337842|"~     This is phase I, double blind, placebo-controlled safety and infectivity study of~     experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of~     age. Subjects susceptible to the human norovirus GII.4 challenge strain. The challenge study~     will be conducted in 2-3 cohorts of approximately 20 subjects each.Subjects will remain in~     the inpatient facility for at least four days following challenge and assessed daily for~     clinical and virologic evidence of norovirus infection. The primary objectives are to~     evaluate the safety and reactogenicity of the norovirus GII.4 (CIN-1; 031693) challenge~     stock and to determine a safe and optimal challenge dose of Norovirus GII.4 Challenge Stock~     norovirus to achieve illness in > /=50% of subjects. Illness is defined as: diarrhea (>3~     loose or liquid stools or >300 gm of loose or liquid stool /24h), and/or vomiting during the~     inpatient period, in a participant with evidence of infection.~   "
54951|NCT02337829|"~     This study is to determine the response to acalabrutinib in patients with chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
54952|NCT02337816|"~     Endometriosis is one of the most common benign gynecological, affecting about 10% of~     premenopausal women. The pathophysiology of this disease is still not completely clear.~     Despite its prevalence, there is no blood test available for the diagnosis of endometriosis~     and the average delay time to diagnosis is 9.4 years.~      Metabolomics is a scientific discipline that studies changes in metabolites related to the~     pathophysiology of the disease.~      Aim of the study is to identify an alteration in the expression of the metabolites in women~     with endometriosis~   "
54953|NCT02337803|"~     The study will aim to determine the effectiveness of a strength training program using~     resistance bands to increase strength in adults ≥65 years old~   "
54954|NCT02337790|"~     This study is designed to validate the use of the CoVa Monitoring System in subjects with~     implanted devices.~   "
54955|NCT02337777|"~     The purpose of this study is to study the diagnostic efficiency of functional magnetic~     resonance imaging in Abdominal and Pelvic Diseases.~   "
54956|NCT02337764|"~     The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with~     levodopa in Japanese participants with Parkinson's disease.~   "
54957|NCT02337751|"~     The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in~     Japanese participants with early Parkinson's disease.~   "
54958|NCT02337738|"~     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1~     mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with~     wearing-off phenomenon.~   "
54959|NCT02337725|"~     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day)~     administered to Japanese patients with early Parkinson's disease.~   "
54960|NCT02337712|"~     This Phase II randomized study is to determine whether once-daily simultaneous modulated~     accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for~     patients with limited-stage small-cell lung cancer (LD-SCLC).~   "
54963|NCT02337673|"~     The purpose of this study is to determine whether Electrical Impedance Tomography can be~     used as sensitive and specific predictor in the detection of postoperative pulmonary~     complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural~     effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia,~     hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric~     surgery.~   "
54964|NCT02337660|"~     The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is~     associated with hepatic glucagon resistance and hyperglucagonemia.~   "
54965|NCT02337647|"~     The purpose of the research study is to evaluate how well the Distortion Correction Data~     Collection (DCDC) App works. The DCDC App is an experimental software application that is~     being developed at the University of Nebraska Omaha. The DCDC app will map and draw the~     visual distortions of patients with Age-related Macular degeneration.~   "
54966|NCT02337634|"~     The goal of the proposed study is to evaluate the efficacy and safety of silymarin in~     individuals with gambling disorder. The hypothesis to be tested is that silymarin will be~     more effective and well tolerated in subjects with gambling disorder compared to placebo.~     The proposed study will provide needed data on the treatment of a disabling disorder that~     currently lacks a clearly effective treatment.~   "
54967|NCT02337621|"~     Recovery following major surgical procedures can be influenced by both physical~     (optimization of cardiopulmonary function, pain control, activity) and psychological~     factors. Physical activity recommendations for post-operative patients is difficult, in part~     because little is known about the short- and long-term benefits of exercise and mobility on~     post-operative pain and return to normal functioning.~   "
54968|NCT02337608|"~     -  Approximately 60 patients suffering from moderate to severe ulcerative colitis will be~          evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or~          matching placebo once daily for 12 weeks in addition to their stable background~          treatment.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur (safety and tolerability), and the amount of GLPG1205 present in the~          blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism~          of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies~          will be determined.~   "
54969|NCT02337595|"~     The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early~     post-transplant is a safe way to improve immunity to common infections in recipients of~     TCR-alpha/beta depleted hematopoietic stem cell grafts.~   "
54970|NCT02337582|"~     A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to~     evaluate the effects of an opportunistic (hospital-based) screening program (intervention)~     vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or~     control arm (N=13). At intervention clinics general practitioners were instructed to perform~     clinical breast examination (CBE) on all women aged 50-69 years attending clinics for~     non-breast health related issues, and to refer them for mammographic screening. Physicians~     from control clinics were not specifically instructed to perform breast-screening or refer~     women for mammography, but could do so if they thought it appropriate ('usual care'). Women~     were followed for 2 years post-randomization.~   "
54971|NCT02337569|"~     The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with~     Zinc Deficiency.~   "
54972|NCT02337556|"~     To compare the nutritional effect on blood glucose of two commercially available enteral~     diets in overweight or obese patients in the Intensive Care Unit.~   "
54973|NCT02337543|"~     This study is a double blind, placebo controlled, ascending single and multiple oral dose~     study conducted in two parts, aimed at determining the safety and tolerability of single and~     multiple oral doses of NEO6860 in healthy subjects.~      Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and~     gender.~      The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked~     pain methods.~      Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an~     ascending multiple dose, with 2 dose levels.~   "
54974|NCT02337530|"~     The purpose of this study is to find out what effects a new drug, selumetinib, has on lung~     cancer when receiving standard chemotherapy with pemetrexed and platinum-based chemotherapy.~   "
54975|NCT02337517|"~     This pilot clinical trial studies how well vismodegib works in treating patients with~     chronic graft-versus-host disease that did not respond to previous steroid treatment.~     Chronic graft-versus-host disease can cause a build-up of scar tissue under the skin and~     lead to symptoms such as sclerodermatous skin changes, dry mouth, dry eye, narrowing of the~     esophagus, or vaginal graft-versus-host disease. Vismodegib may work against the build-up of~     scar tissue and be a better treatment for chronic graft-versus-host disease caused by a~     hematopoietic stem cell transplant.~   "
54976|NCT02337504|"~     Tremendous efforts and resources have been expended by the global community to ensure that~     antiretroviral therapy (ART) is available and accessible to all that need it. Despite these,~     less than a half of Human Immunodeficiency Virus (HIV)-infected patients requiring ART in~     sub-Saharan Africa (SSA) are receiving it. Some of the most significant barriers to~     attaining universal access to ART in this region include large distances that patients have~     to travel to clinic, time spent in accessing care and a significant shortage of human~     resources. In order to address these challenges the World Health Organization (WHO)~     advocates alternative care models especially those that incorporate task-shifting to lower~     cadre health care workers and lay persons. Unfortunately, few such alternative care models~     have been identified and very little data exist on their long-term outcomes.~      With this project we will develop and assess an alternative care model that is established~     on the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health~     workers (CHW's). This model of care is intended to decentralize ART services and bring them~     closer to the patients. Specifically, we will:~        1. Develop an acceptable and sustainable model for extending HIV care and treatment into~          the community.~        2. Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops~          program to those receiving standard of care.~        3. Determine the cost savings and cost effectiveness of ART Co-ops.~   "
56298|NCT02320214|"~     To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a~     personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for~     two weeks in a population of healthy females.~   "
54977|NCT02337491|"~     In this research study, the investigators are looking to determine the effectiveness of~     Pembrolizumab (MK-3475) when given with bevacizumab or when given alone for the treatment of~     recurrent glioblastoma multiforme (GBM). This study will also test the safety and~     tolerability of Pembrolizumab (MK-3475) when given alone or with bevacizumab.~   "
54978|NCT02337478|"~     This pilot phase II trial studies how well vincristine sulfate liposome works in treating~     patients with acute myeloid leukemia that has returned after a period of improvement or has~     not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate~     liposome, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Liposomal~     encapsulation prolongs bioavailability (proportion of drug that enters the circulation when~     introduced into the body) of vincristine sulfate, and may increase its delivery to cancer~     cells with fewer side effects.~   "
54979|NCT02337465|"~     This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and~     ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or~     pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors~     to create a 3-dimensional picture of the tumor may help in planning radiation therapy and~     may result in more tumor cells being killed.~   "
54980|NCT02337452|"~     Objectives:~      To develop a secure, web-based program for family outreach in Clinical Cancer Genetics~     (CCG).~      The long-term goals of this program are expected to include, but are not limited to the~     following:~        1. To enable families with inherited cancer susceptibility and/or at increased familial~          risk of cancer to provide personal and family history of neoplasia through a convenient~          and self-directed program.~        2. To enable communication of possible inherited cancer susceptibility with and among~          family members through the web-based portal.~        3. To facilitate genetic testing, screening and prevention strategies in those at risk.~        4. Establish high-risk cohort for optional participation in research and clinical trials.~   "
54981|NCT02337439|"~     In this study, participants with schizophrenia and schizoaffective are given computer~     exercises to complete. The goals of the study are to determine whether: 1) any of the~     computer exercises can improve information processing problems in schizophrenia, 2)~     improvements in information processing are related to other cognitive improvements, and 3)~     there are changes in brain activity associated with using the computer exercises.~      The study will involve clinical interviews, cognitive tests, and frequent computerized~     cognitive training over the course of 2 months. Some participants will also have~     electroencephalography, a non-invasive test that measures brain activity, to determine~     whether there are changes in brain activity with the computer training.~   "
54982|NCT02337426|"~     This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given~     together with temozolomide and radiation therapy(RT) in treating patients with newly~     diagnosed glioblastoma multiforme (GBM). Dimethyl fumarate may help radiation therapy work~     better by making tumor cells more sensitive to the radiation therapy. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving dimethyl fumarate with temozolomide and radiation therapy may work better in treating~     glioblastoma multiforme.~   "
54983|NCT02337413|"~     Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal~     enuresis (bed wetting at night). This study aims to explore if treatment of patients without~     overt constipation (As defined by the ROME III criteria) will also respond to stool~     softening and GI behavioral therapy with reduction of their urinary tract symptoms when~     added to standard urotherapy.~   "
54984|NCT02337400|"~     The aim of this study is to evaluate a new cognitive behavioral smoking reduction program~     for ambulant patients in a three-armed study design. Study participants will be randomized~     to one of the following three study groups: experimental group: 5-week lasting cognitive~     behavioral reduction program (smoke_less); active comparator: 15 minutes counseling~     interview; waiting group: no intervention.~      The three follow-up measures take place after the reduction program in week 6, 17 an 29.~     After the finalisation of the last follow-up, participants from the active comparator and~     waiting group get the chance to take part at the smoking reduction program at no charge.~   "
54985|NCT02337387|"~     The purpose of this study is to evaluate the tolerability of two different formulations of~     blosozumab in women who have reached menopause.~      This study will last approximately 12 weeks for each participant, not including screening.~     Screening is required within 28 days prior to starting the study.~   "
54986|NCT02337374|"~     Purpose The aim of this study is to investigate the contribution of preoperative urodynamics~     to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and~     easily accessible tools Methods Women with stress urinary incontinence and who desired~     surgical correction of their incontinence were included in the study. The selection of the~     procedure was according to an algorithm used in an institution developed by a chief of~     urogynecology department who had 25 years of urogynecology experience. Urodynamic and~     baseline factors that may be associated with surgery failure were analyzed in MUS failure.~   "
54987|NCT02337361|"~     An innovative, self-administered computerized screening and brief intervention (SBI) for~     drinking during pregnancy will be adapted for use with non-pregnant childbearing age women~     and its efficacy will be tested in a small trial. Study findings will inform a larger~     randomized control trial for a primary prevention tool with the potential for broad health~     impact.~   "
54988|NCT02337348|"~     Coronary artery intervention with stents is a routine procedure with several clinical~     indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some~     patients. Several different mechanisms have been suggested. Stentfailure may be caused by~     mechanical properties of the stent. This may be secondary to suboptimal stentimplantation,~     ie over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may~     be difficult to identify with conventional coronary angiography due to low image resolution.~     The hypothesis of the study is that high resolution imaging with optical coherence~     tomography (oct) will improve diagnosis and enable a more specific or tailored treatment~     with a subsequent reduction in later stentfailure.~   "
54989|NCT02337335|"~     Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and~     Iron adminsitration in hemodialysis patients.~   "
54990|NCT02337322|"~     There are few randomized clinical trials in advanced HIV patients. This is a multicenter,~     randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological~     reconstitution and the virological efficacy and safety of 2 different combinations of~     antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either~     dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1~     infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median~     increase in CD4+ T-cell count at 48 weeks after starting HAART.~   "
54991|NCT02337309|"~     SF1126 is a novel inhibitor of PI3 kinase and mTOR that includes an active moiety~     (consisting of LY294002) linked to an RGDS tetrapeptide that targets the active agent to~     integrin expressing tissues. In this first pediatric phase 1 trial of SF1126, dose~     escalation will follow a 3+3 dose escalation design. Once a recommended phase 2 pediatric~     dose is identified, an expansion cohort of 10 patients with tumors with MYCN amplification,~     Mycn expression, or Myc expression will be treated.~   "
54992|NCT02337296|"~     This study includes a novel intervention entitled ADHERE, which includes one~     semi-structured 30-minute face-to-face session and three 10-minute weekly phone sessions~     over 4 weeks, administered by an advanced practice nurse (APRN) to promote management of~     symptoms and adherence in patients prescribed oral anti-cancer agents. Innovations in cancer~     treatment are changing the treatment delivery landscape. It is projected that by 2015, 25%~     of treatment will be delivered in pill form. This shift in the treatment paradigm places~     greater responsibility on patients. However, patients with cancer are known to miss as much~     as one-third of the prescribed doses of oral agents required for treatment of their disease.~     Barriers to oral agent adherence include symptom severity, low self-efficacy, depressive~     symptoms, lack of motivation, or beliefs that the medicine will not help, age, and regimen~     complexity. The therapeutic outcome for those taking oral agents depends heavily on the~     ability of patients to adhere to the prescribed regimen. Thus, a critical need exists to~     test interventions that promote adherence and symptom management in patients taking oral~     agents.~      ADHERE provides systematic patient education (PE) with the investigators evidence-based~     Medication Management and Symptom Management Toolkit (Toolkit). This is combined with brief~     cognitive behavioral therapy (CBT) to focus thoughts and beliefs to influence action; and~     motivational interviewing (MI) to elicit reasons from patients to take action. The National~     Cancer Institute (NCI), American Society of Clinical Oncology (ASCO), and Oncology Nursing~     Society (ONS) have made adherence to oral agents a priority. Thus, the investigators are~     testing ADHERE's impact on symptom severity and adherence to the oral agent regimen and~     determining the acceptability and feasibility of the intervention among patients with~     cancer.~   "
54993|NCT02337283|"~     The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of~     multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and~     elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI~     425809 given in the morning and in the evening.~   "
54994|NCT02337270|"~     This is a phase 1 study, in healthy volunteers who have previously been immunized with~     bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in~     the blood and lungs following the administration by aerosol of a new experimental~     adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.~   "
54995|NCT02337257|"~     Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are~     shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely~     available and cheap supplement that has shown beneficialeffect in the immune system~     regulation and maintenance of the cardiovascular health. In this study The investigators~     hypothesize thatvitamin D supplementation for 16 weeks in African Americans with~     periodontitis will result in clinical improvement in theirgum health as well as their~     cardiometabolic risk profile~   "
54996|NCT02337244|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona knee implants used in primary total knee~     arthroplasty. The assessment will include:~        1. Implant survivorship based on removal of a study device.~        2. Safety based on incidence and frequency of adverse events.~        3. Clinical performance measured by overall pain and function, quality of life data,~          radiographic parameters and survivorship.~   "
54997|NCT02337231|"~     A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to~     determine whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids~     (MC-PUFAs) in botanical oil supplements are changed in relationship to specific genotypes in~     a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism.~   "
54998|NCT02337218|"~     This is a double‐blind randomized clinical trial. Both patients and the podiatrist that will~     evaluate and monitor study patients will be blinded to electrical stimulation application.~     The manufacturer of the units will be asked to not inform which patient received which unit.~     Each unit will be coded with a unique identification number, and the manufacturer units~     revealed their status, placebo or electric stimulation, only at the end of data collection~     for the last patient. Subsequently, the investigators could match the status of the~     identification numbers with the corresponding units to start analyzing the data. Patients~     that receive an activated electrical stimulation unit will receive a standard dose of 50~     volts as described above.~      The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral~     neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus~     will be based on World Health Organization criteria.(World‐Health‐Organization 1999). The~     inclusion and exclusion criteria are described in table III. The clinical assessments are~     described in table IV. The investigator will discuss the study design, duration, and its~     risks with potential subjects asked to participate. The participant will be provided with a~     consent form to read at their leisure. The investigator will be available to answer~     questions or provide more explanation as requested by potential participants and their~     family.~   "
54999|NCT02337205|"~     This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in~     subjects who have Actinic Keratosis. This study will also access the amount of KX2-391 drug~     that enters the blood stream through dermal application of the ointment.~   "
55000|NCT02337192|"~     We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral~     decontamination agent. It was also shown that SDS surfactant improves the antibacterial~     action of APDT when using Curcumin as the photosensitizer. The decontamination levels~     obtained with APDT are comparable with the levels observed with the use of Chlorhexidine.~     The clinical relevancy is the control of oral microbial load which will improve the~     patients' quality of life and will decrease the possibility of cross contamination in the~     dental office.~   "
55001|NCT02337179|"~     The purpose of this study is to determine the feasibility of introducing voluntary medical~     male circumcision as a form of HIV prevention in high HIV prevalence areas in the Dominican~     Republic.~   "
55002|NCT02337166|"~     BACKGROUND: Periodontal disease is an infection that results in progressive loss of dental~     support, which may lead to tooth loss.. The goal of the present study was to evaluate if~     recombinant human Fibroblast Growth Factor type 2 (rhFGF-2) applied in periodontal intrabony~     defects in a hyaluronic acid (HA) carrier would enhance the clinical paramenters of~     regeneration of the periodontal attachment apparatus and the long-term maintenance of the~     results obtained. METHODS: Thirty adult patients were evaluated. Initial treatment consisted~     in plaque control measures executed previously to the experimental phase. Two intra-bony~     defects in each patient were ramdomly allocated for each of the treatment methods employed.~     Control group (n=30) were treated by open debridement with the papilla preservation flaps,~     while the text group (n=30) also received a topical application of rhFGF-2/HA in the~     intrabony defect. The parameters evaluated were, probing depth (PD), gingival recession~     (REC), probing attachment level (PAL) and probing bone level (PBL). Clinical measurements~     obtained at baseline and 1, 5 and 10 years after the surgical procedure were compared.~   "
55003|NCT02337153|"~     Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of~     treatment and tooth movement.~   "
55004|NCT02337140|"~     Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change~     in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this~     intervention may induce heavy conduction disorder due to the proximity of the aortic annulus~     and the conduction pathways. So far, there is no clear recommandation for clinical~     management of conduction disorder after TAVI. Standard criterion cannot be applied due to~     the multiple comorbidity factors observed in these patients. As described in conventional~     aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may~     be involved in the first days. This is the reason underlying the systematic implantation of~     epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients.~      The primary end-point of this study is to confirm that standard criterion for pacing are~     reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic~     electrophysiological study (EPS).~      In TAVI patients, indications for pacing were persistent high-degree atrioventricular block~     (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours~     after the procedure.~      After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will~     be realized in patients without pacemaker and compared to data obtained from the devices in~     pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB~     episod).~   "
55005|NCT02337127|"~     Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic~     hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg~     seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months~     apart (primary treatment endpoint). Stopping treatment can be considered if undetectable~     HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative~     patients. However, oral antiviral drugs currently approved for the treatment of CHB have~     relatively limited sustained long-term efficacy and a large proportion of patients will~     suffer from HBV recurrence after stopping treatment.~   "
55006|NCT02337114|"~     Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe~     Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression,~     anxiety and low self awareness. A key factor in recovery is adjustment to the effects of~     injury. Psychological intervention may facilitate this change; however what works is~     unclear. ACT seeks to improve psychological flexibility; the ability to be present with~     difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we~     are, not what we believe we should be. Current research is limited, but what is published~     suggests it may be useful for this group.~      Due to the limited research this pilot study aims to conduct preliminary analysis on the~     acceptability and feasibility of ACT for people with sTBI whilst also examining the~     suitability of the study protocol in order to make recommendations for future studies.~     Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be~     recruited, one of which will serve as the intervention centre.~      Clients in the intervention group will be asked to complete questionnaires a week before and~     after participation in the 6 week ACT programme. Clients in the comparison group will be~     asked to complete questionnaires a week before and after receiving 6 weeks of treatment as~     usual (TAU). The treatment group will also receive TAU. All participants will be invited to~     participate in a focus group at the end of this 8 week period to discuss their involvement~     in the study.~      Staff will be asked to complete a parallel version of one of the client questionnaires~     within a similar timeframe. In addition staff at the intervention centre will be invited to~     attend a focus group and complete an additional questionnaire after the eight week period.~   "
55007|NCT02337101|"~     Background:~      Five - 15 % of patients with concussion continue to experience impairing physical, cognitive~     and emotional symptoms longer than 3 months post-injury. Currently, no standardised~     treatment is available for patients with persistent post-concussional symptoms (PCS) and~     systematic treatment studies remain limited.~      Aim:~        1. to develop an early intervention programme based on principles from~          cognitive-behavioural therapy and graded exercise for young patients with PCS lasting~          more than 3 months, and~        2. to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.~      Methods:~      Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region~     will be screened for persistent symptoms two months post-injury. Those with impairing~     symptoms will be invited to participate in a randomised controlled trial comparing the early~     intervention programme with enhanced usual care. We expect to include 120 patients from~     2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months~     after concussion. All patients will complete self-report measures at baseline and 3, 6 and~     15 months after randomisation. The primary outcome is severity of PCS.~   "
55008|NCT02337088|"~     The purpose of this study is to determine if there is a difference in neonatal outcomes with~     delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be~     intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.~   "
55049|NCT02336555|"~     This study aims to determine whether MK-8291 is effective in reducing pain in participants~     with post-herpetic neuralgia (PHN) with allodynia. The primary hypothesis is that when~     compared to placebo, treatment with MK-8291 reduces the change from baseline in~     participant-reported pain intensity by 1 on an 11-point numeric rating scale.~   "
55009|NCT02337075|"~     Being physically active is important for everyone's health, but it is often challenging for~     people to start and sustain an activity routine. The investigators will develop and pilot~     test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl~     District Council (KDC) Health on North Vancouver Island. The project idea was conceived~     through a partnership between the communities and University of British Columbia health~     researchers. The PATH program will include an education sessions on how to be active,~     physical activity coaching by community health workers, and the use of Fitbit Flex (a~     wearable activity tracker). The investigators will develop a culturally appropriate online~     application to pair with Fitbit, which will provide instant feedback to individuals about~     their activity level. 60 community members will be recruited to test the PATH program. Their~     physical activity level, health status and use of activity resources at KDC Health Centres~     will be assessed.~   "
55010|NCT02337062|"~     A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic~     in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting~     (PONV).~   "
55011|NCT02337049|"~     In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we~     will conduct a 10-year follow-up study comparing 40 women with a history of early onset~     preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history~     of normotensive pregnancies.~      Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital~     1998-2008.~      Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of~     gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.~   "
55012|NCT02337036|"~     Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its~     use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study~     is designed to assess the posology of tacrolimus in post-transplantation in the month after~     liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of~     biological and genetic factors on the pharmacokinetic parameters in paediatric liver~     transplant recipients.~   "
55013|NCT02337023|"~     The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy~     subjects.~      These results will be compared with data obtained out of episode in patients with~     Kleine-Levin syndrome (KLS).~      The investigators want to determine if brain functional imaging and cognitive abnormalities~     persist during asymptomatic period in a large series of patients with KLS, and to find~     predictors of these abnormalities.~   "
55014|NCT02337010|"~     Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy,~     pancreas resection, major vascular, total cystectomy will be recruited.To investigate~     effects of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid~     management on intraoperative haemodynamic parameters, volume and vasopressor requirement,~     and postoperative organ function and postoperative inflammatory response.~   "
55015|NCT02336997|"~     The purpose of this study is to evaluating whether autologous grafted fat transplantation or~     SVF transplantation is safe and/or effective to accelerating skin regeneration and soft~     tissue expansion.~   "
55016|NCT02336984|"~     The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a~     combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will~     assess the safety and immunogenicity of the combination therapy. The target population is~     women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.~     Participants will receive 6 vaccines along with 2 doses of trastuzumab.~      This study began at the Abramson Cancer Center of the University of Pennsylvania and will~     continue at H. Lee Moffitt Cancer Center and Research Institute.~   "
55017|NCT02336971|"~     This study seeks to enroll 76 couples in which one of the members is a combat-veteran with~     PTSD. Each couple will be randomized into one of two cognitive-behavioral therapies~     developed specifically as a treatment for PTSD—either Prolonged Exposure (PE) [1-4] or~     Cognitive-Behavioral Couples Therapy (CBCT) [5-7]. Whereas, PE was developed as a one-on-one~     therapy that focuses on treating the individual, CBCT for PTSD incorporates the partners~     into therapy and seeks to directly address relationship functioning while treating the PTSD~     symptomatology. Both partners in each couple will complete a battery of several assessments~     measuring various aspects of psychological distress (e.g., depression, PTSD) and~     relationship functioning at five time-points throughout the study. But, only the partners~     assigned to the CBCT group will be involved in the actual therapy sessions. Analysis will be~     carried out to identify whether any significant differences exist between PE and CBCT in~     treating PTSD and improving relationship functioning.~   "
55018|NCT02336958|"~     For ultrasound guided intermediate cervical plexus block this randomized comparison is~     testing the hypothesis, that an additional perivascular infiltration is associated with~     increased block quality.~   "
55019|NCT02336945|"~     This is a multi-center, prospective, non-pivotal, single arm, non-significant risk~     evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages~     of T2 diabetes management. This is a non-significant risk study.~   "
55020|NCT02336932|"~     The purpose of this study is to describe changes in vitamin D parameters before, during and~     after a well-defined elective surgical trauma (knee arthroplasty) and to compare these~     changes to other steroid hormones (testosterone and oestrogens). The hypothesis is that~     profound changes in free and total vitamin D will occur as a result of changes between~     intravascular vs extravascular protein compartments during surgical trauma.~   "
55021|NCT02336919|"~     Participants will be recruited during their hospitalization for either heart attack or~     unstable angina and will be randomly assigned to either a text message program (Txt2Prevent)~     or usual care. They will be texted for the first 60-days after discharge. Texts will include~     topics regarding self-management and discharge protocols such as reminders to make an~     appointment with their general practitioner or to refill medication prescriptions. After 60~     days, the two groups will be compared for hospital readmission rates, quality of life,~     medication adherence, and self-management.~   "
55054|NCT02336490|"~     This randomized pilot study proposes to field-test key logistical aspects of studying an~     intervention already available to patients on the pediatric ward, namely a discharge~     medication delivery service, called Meds-in-Hand, which has been refined via a quality~     improvement process, but not rigorously studied nor fully implemented.~   "
55022|NCT02336906|"~     Constipation treatment has been found to ameliorate symptoms in some patients with lower~     urinary tract dysfunction (including day time or combined day time/night time urinary~     incontinence). This study aims to explore if treatment of patients without overt~     constipation (As defined by the ROME III criteria) will also respond to anti-constipation~     treatment with reduction of their urinary tract symptoms. Assessment of severity and~     response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES~     questionnaire.~   "
55023|NCT02336893|"~     The purpose of this study is to assess whether a formal training strategy using an interview~     PACIENTE may improve physician's skills and quality of communication with family members at~     the ICU.~   "
55024|NCT02336880|"~     This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness~     of a guided internet-delivered cognitive behavioural therapy intervention in the treatment~     of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The~     control group will receive care-as-usual.~   "
55025|NCT02336867|"~     Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common~     and generally associated with pain, anal incontinence, impaired quality of life and work~     incapacity. The therapeutic management of this disease has a double objective: heal the~     suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000~     in the normal population, with a difference in prevalence between men and women (1.23 per 10~     000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et~     al., 2012).~      In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses'~     anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an~     abscess between the internal and external sphincters, which in turn can spread to other~     parts of the perianal region. The infection can follow many directions from this point in~     the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal~     fistula therefore has always an intraductal origin, cryptic, with a primary port at this~     level, and the disregard of which causes the recurrence of the fistula; and usually a~     secondary port in the skin.~      Fistulas are usually divided into two groups. The first group contains fistulas called~     simple, which are intersphincteric fistulas or trans-sphincteric involving only the lower~     third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group~     contains fistulas called complex. These are intersphincteric, trans-sphincteric, or even~     suprasphincteric, extrasphincteric fistulas.~      For many years, the treatment of choice was to open the fistula (fistulotomy), but this~     procedure was associated with a risk of incontinence, the consequences could be potentially~     devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and~     advancement flap technique to cover internal opening of the fistula. The success of these~     therapies remains variable.~      The advancement flap technique remains a strategy of choice in the treatment of anal~     fistulas and particularly in the case of complex fistulas. The success rate of the~     advancement flap technique remains variable across studies but a recent meta-analysis finds~     a success rate of around 60%.~      A new technique for closing anal fistula is currently in development with the use of a~     closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life~     Partners). This new technique has been validated in a porcine model of anal fistula,~     ensuring the safety of the device. A first case was published in a patient with complex anal~     fistula (high trans-sphincteric). After erosion fistula tract with a special brush, a~     nitinol clip (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight~     months after surgery, the fistula was healed and the clip was removed by cutting with~     special pliers. This technique is currently being broadcast and dozens of patients were~     treated with this clip without any further scientific validation of the process.~      To date, this innovative technique of the closure clip has not yet been assessed in a~     randomized controlled trial. It is therefore essential to carry out a prospective evaluation~     in order to determine the effectiveness and safety of this new device in the case of complex~     anal fistulas.~   "
55026|NCT02336854|"~     A randomized, open-label, two-way crossover study to assess the tolerability and~     pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy~     male volunteers.~   "
55027|NCT02336841|"~     The aim of this study is to test a novel guided self-help intervention for patients with~     Anorexia Nervosa. The 6-week intervention includes the use of self-help materials (i.e. a~     workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person~     recovered from Anorexia Nervosa). Self-reports will be completed at baseline, end of 6~     weeks, and 6- and 12 months follow-up. Participants interested in taking part will be~     randomly allocated to one of two groups.~   "
55028|NCT02336828|"~     This study is to validate the use of the modified early warning score (MEWS) in an adult~     oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It~     is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading~     will be associated with an increased risk of death or ICU admission, and should be regarded~     as a MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and~     aggressive management of life-threatening complications in oncology patients, results in~     dramatic improvements in overall survival rates.~      This is a prospective, single centre, observational, cohort study. Objective of this study~     is to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day~     mortality in adult clinical oncology ward patients.~      The alternate hypothesis of this study is a significant difference in 7 day mortality~     between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients~     without a MEWS alarm.~      The null hypothesis is a no significant difference in 7 day mortality between adult oncology~     ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.~      The primary outcome measure in this study is the number of patients who die within 7 days of~     a MEWS Alarm (7 day mortality).~      The secondary outcome measure in this study is the number of patients admitted to ICU within~     7 days of a MEWS Alarm.~   "
55029|NCT02336815|"~     This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus~     dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with~     penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).~   "
55030|NCT02336802|"~     Anxiety disorders are characterized by exaggerated levels of fear that are not proportional~     to the actual level of threat. More specifically, anxiety patients have marked deficits in~     the downregulation of fear reactions during situations of objective safety. Pre-clinical~     research on Pavlovian fear conditioning and extinction has discovered that fear~     downregulation stems from areas in the prefrontal cortex (the ventro-medial prefrontal~     cortex, vmPFC) that recruit intercalated cells in the amygdala to inhibit its central~     nucleus, which is responsible for a variety of behavioral expressions of fear (Milad &~     Quirk, 2012). Accordingly, functional magnetic resonance imaging studies (fMRI) revealed~     reduced vmPFC activity coupled with increased fear reactions during situations of objective~     safety in anxiety patients (Milad et al., 2009). Another core symptom of anxiety disorders,~     though much less investigated, is the excessive avoidance of situations that trigger the~     fears. These 'safety behaviors' often interfere with daily life activities and valued goals~     in life, and they are thought to perpetuate the exaggerated levels of fear by precluding~     opportunities to learn that the feared situations are actually not dangerous. Surprisingly,~     experimental research on avoidance behaviors in anxiety patients is virtually non-existent.~     This experiment modifies the Pavlovian fear conditioning procedure to include avoidance, and~     explores the behavioral and neural processes of this type of fear regulation in anxiety~     patients (trans-diagnostically) and healthy individuals.~   "
55031|NCT02336789|"~     The investigators propose to transplant feces from thin, disease-free donors into obese~     patients undergoing colonoscopy for screening for colorectal carcinoma.~      The investigators will obtain feces from healthy donors with a BMI of between 21-24. The~     investigators will perform colonoscopy on healthy patients with a BMI of 30-40 kg/m2 who~     have a clear indication for a screening examination.~      All patients will undergo a screening colonoscopy and will be allocated to receive either~     250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of~     normal saline (sham transplantation).~      The patients will be reviewed at 1 3 6 and 12 months. At this time note will be made of~     their weight, BMI and waist circumference. In addition note will be made of their fasting~     glucose and lipid profile.~   "
55050|NCT02336542|"~     96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are~     divided into different groups through a randomized, blind methods.Every subject inject~     intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ-~     IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity~     (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence~     rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung~     diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of~     tuberculosis.~   "
55051|NCT02336529|"~     Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer~     survivors and nerve damage has been implicated as the cause of this neuropathic pain~     condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve~     (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and~     treatment of PPBCS but has never been attempted. The aims of this study is to examine~     clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.~   "
55032|NCT02336776|"~     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney~     function and in its most advanced stage is called chronic renal failure.~      Although hemodialysis replace some kidney function, patients suffer some alterations~     characterized by uremic syndrome typically expressed by: motor neuropathy and/or autonomic~     neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among~     others. Thereby, the the adoption of physical exercise should be encouraged. However, it is~     known that the ability to exercise the subject in hemodialysis is low and keeping in mind~     the weakness of the muscular system in these individuals, the aim of this study is to assess~     the effects of functional electrical stimulation (FES) on muscle architecture of patients~     with chronic kidney disease hemodialysis.~      For this the following assessments will be performed before and after stimulation:~     ultrasonography to assess muscle architecture; six-minute walk test to functional capacity;~     Kidney Disease and Quality of Life - Short Form questionnaire for quality of life; sit and~     stand test for resistance of the lower limbs; dynamometric by load cell for muscle strength~     of the lower limbs; flow-mediated dilatation to endothelial function; blood collection for~     analysis of inflammatory markers and DNA damage.~      The subjects will be randomized into two groups, FESG (functional electrical stimulation~     group) and CG (control group). The first will receive the FES in the quadriceps muscle of~     both thighs, for eight weeks, three times a week during hemodialysis session. While the~     control group only will be evaluated and re-evaluated.~      Expected results at the end of the protocol with FES are: increased quadriceps muscle~     thickness; longest distance covered on the six-minute walk test; improved quality of life;~     increase in resistance of the lower limbs; increased muscle strength of the lower limbs;~     improved endothelial function; improved inflammatory status and DNA damage.~   "
55033|NCT02336763|"~     This clinical trial studies giving radiation therapy to the liver in patients with uveal~     (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2~     and therefore more likely to have their disease spread from the eye to the liver. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to~     the liver may reduce the development of tumors in the liver and the overall risk of disease~     recurrence.~   "
55034|NCT02336750|"~     Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in~     Delayed Emesis Control and Appetite Improvement~   "
55035|NCT02336737|"~     The purpose of this pivotal study is to provide prospective evidence that the~     SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node~     localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB)~     procedure and to summarize measures of product safety and performance.~   "
55036|NCT02336724|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with advanced or metastatic gastrointestinal stromal tumor who failed from imatinib~     therapy.~   "
55037|NCT02336711|"~     Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based~     Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.~   "
55038|NCT02336698|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of~     osteoarthritis of the hip or knee that are not adequately controlled by current pain~     therapy.~   "
55039|NCT02336685|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate~     to severe pain and functional impairment from knee or hip osteoarthritis that is not~     adequately controlled by current pain therapy.~   "
55040|NCT02336672|"~     In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various~     modalities as a way to decrease size and downstage the tumour leading to a re-sectable~     disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany)~     com-bines bipolar RF-ablation with cryogenic induced cooling. It is well known that a~     bipolar radiofrequency system creates ablation with less collateral thermal damage than~     standard monopolar systems but with the trade-off to lose overall efficiency.~   "
55041|NCT02336659|"~     The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones~     (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after~     Roux-en-Y gastric bypass surgery.~   "
55042|NCT02336646|"~     Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions~     using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study~     in treating 18 recipients with ischemic limb diseases.~   "
55043|NCT02336633|"~     The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the~     caudate volume in HD patients, using volumetric MRI.~   "
55044|NCT02336620|"~     The Purpose of this study is to determine the impact of balanced salt solution versus~     chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock~   "
55045|NCT02336607|"~     The purpose of this study is to evaluate the effects on blood pressure control, pulse wave~     velocity, as well as safety and tolerability of felodipine single or combine with other~     drugs in Chinese Hypertension patients.~   "
55046|NCT02336594|"~     This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and~     pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative~     bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)~     and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat~     and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.~   "
55047|NCT02336581|"~     To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced~     Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum~     disorders.~   "
55048|NCT02336568|"~     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the~     hypothalamus - is a mediator stress regulation and improves social bonding. Recently,~     several theoretical studies suggested that PTSD patients have abnormal functioning of the OT~     system. According to these theories, dysfunction in the oxytocin system may modulate the~     interpersonal impairment that characterizes PTSD, and therefore intranasal OT may~     potentially relieve these symptoms. In two current studies that were conducted in Rambam~     health care we found that a single dose of intranasal OT reduces anxiety and irritability~     symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main~     goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical~     symptoms and social function in these patients.~   "
55052|NCT02336516|"~     Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal~     failure in children less than 5 years old in France. Previous works highlighted a mortality~     rate of 2 % and a prevalence of renal sequelae at one year after D+HUS onset in 25 % of~     patients D+HUS is a consequence of a gastrointestinal infection with shiga toxin (Stx)~     producing E.coli (STEC). The most frequent straight is E.coli O157H7. The sequence of STEC~     induced HUS is now well known. Typically, digestive symptoms appear five days following STEC~     ingestion. STEC colonize the intestinal mucosa, adhere to the enterocyte and cause a typical~     attaching/effacing lesion and inflammation. Then, diarrhea and vomiting occurred. D+HUS~     occurs in about 10% of patients and is a consequence of Stx systemic absorption. Indeed, Stx~     are released in the gastrointestinal tract, then after transferred to the systemic~     circulation. At the cellular level, Stx binds the globotriosylceramide (Gb3Cer) localized at~     the surface of the endothelial and epithelial cells of target organs. Following binding to~     Gb3Cer, the A subunits of Stx are internalized and trigger the activation of the apoptotic~     program leading to cell death. In addition, Stx are also able to enhance the production and~     the release of pro inflammatory factor (IL-1, TNFα, IL-6). Cytokines locally produced by~     Stx-stimulated cells can amplify the inflammatory processes and the prothrombotic state~     leading to the constitution of the microangiopathic lesions of HUS. To this day, management~     of D+HUS involves supportive care mainly based on fluid management, dialysis and red blood~     cells transfusions. Specific therapies used in D+HUS (plasma infusion, antithrombotic and~     anti inflammatory agents) failed to improve the course of D+HUS. The use of antibiotics~     remains not recommended while meta-analysis clearly showed that the use of bactericidal~     antibiotics could worse the course of D+HUS. In vitro experimentations highlighted that some~     classes of antibiotics like fluoroquinolones dramatically increase the production and the~     release of Stx before bacterial lysis and worsen the outcome of D+HUS in animal models. By~     contrast, azythromycin, a bacteriostatic antibiotic of the macrolides family blocking the~     protein synthesis in bacteria, has a strong inhibitory effect on Stx production and release~     by STEC as well as it inhibits the in vitro growth of STEC strains. In addition,~     azithromycin is able to inhibit the Stx-induced production of inflammatory cytokines which~     are considered to be essential for the development of D+HUS. Consistently the use of~     azithromycin in animal models of D+HUS dramatically improved the survival rate. Preliminary~     data on humans with D+HUS treated with azithromycin highlighted a lower prevalence of severe~     gastrointestinal involvement than in control patients. All these data supported the~     hypothesis that azithromycin should have a beneficial effect on D+HUS and should improve the~     short and long term outcome and deserves to be formally demonstrated in human with D+HUS.~   "
55053|NCT02336503|"~     To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms),~     when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.~   "
55055|NCT02336477|"~     Treatment strategies in non-dystrophic myotonias are based on selective case reports,~     clinical experience and theoretical benefit. Presently, the most promising antimyotonic~     medication is mexiletine (MEX) but its manufacturing was stopped. The proposed randomized,~     double-blind, placebo-controlled, crossover trial is designed to:~        1. study the safety and efficacy of mexiletine for the treatment of non-dystrophic~          myotonias~        2. validate electromyographic tests as a standardized outcome measure of myotonia~        3. assess the reliability and validity of a new clinical rating scale for myotonia~   "
55056|NCT02336464|"~     Although pain has been extensively studied in ICU patients, only a few studies have focused~     on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of~     the present study is to determine whether dyspnea in intensive care unit patients is~     associated with a higher length of stay in the ICU and a higher incidence of post traumatic~     stress disorders.~   "
55057|NCT02336451|"~     This is a phase II, multi-center, open-label, five-arm study in which the efficacy and~     safety of oral ceritinib treatment will be assessed in patients with NSCLC metastatic to the~     brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA~     approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring~     algorithm (including positivity criteria). If documentation of ALK rearrangement as~     described above is not locally available, a test to confirm ALK rearrangement must be~     performed by a Novartis designated central laboratory. Patients must wait for the central~     laboratory result of the ALK rearrangement status before initiating treatment with~     ceritinib.~   "
55058|NCT02336438|"~     One of the emerging complications of RNY gastric bypass surgery is mild to severe~     refractory/ recurrent postprandial hypoglycemia. This complication can lead to a significant~     reduction in quality of life to severe disability. Unfortunately at this time there are no~     treatment guidelines or proven therapeutic options for the treatment of this complication.~     One of the proposed treatment options is the use of fiber supplements to help modify the~     absorption of glucose, slow the food bolus transit time more toward normal and restore the~     postprandial (after meal) glucose homeostasis. The investigators are proposing a pilot~     project for the use of Glucomannan soluble fiber as a treatment option for postprandial~     hypoglycemia in this cohort. This project will help the investigators to identify if~     Glucomannan soluble fiber can be used as an effective dietary supplement to eliminate or~     reduce this condition~   "
55059|NCT02336425|"~     This study will assess the effect on the reduction in rate of severe asthma exacerbations of~     different dose levels of QGE031 in asthma patients that are inadequately controlled with~     inhaled steroid plus beta-2 agonist medication with or without oral steroid. Safety will~     also be assessed. Comparison will be to placebo. Information from this study will inform the~     design of future studies.~   "
55060|NCT02336412|"~     Secondary preventative medications are prescribed to reduce the risk of recurrent stroke~     following ischaemic stroke. However, continuation rates can be as low as 50% and are likely~     to be multifactorial. One factor will be patients forgetting to take the medication or a~     reduced appreciation of the importance of the medication as the time from the stroke passes.~     Numerous approaches to improve persistence to secondary preventative medications have been~     tried. One simple approach is use of mobile phone text messages as a reminder for patients~     to take their medications. In this study, we will introduce an educational and motivational~     strategy to inform patients about their medications and explore whether a reminder~     intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs,~     antihypertensive medications and lipid lowering drugs. We will also explore whether this~     improves blood pressure and cholesterol levels in the first 3 months after stroke.~   "
55061|NCT02336399|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be~     the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and~     the ultimate treatment goal in CHB. However, some patients achieved HBsAg loss would reverse~     back to HBsAg positive, even occur HBV reactive. in this study, the viral and HBsAg response~     in patients achieved HBsAg loss by interferon treatment will be observed for two years after~     completed IFN treatment.~   "
55062|NCT02336386|"~     The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and~     Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.~   "
55063|NCT02336373|"~     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle~     cell disease with typically higher hemoglobin and milder or later disease complications.~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped.~     This can result in painful episodes, serious infections, and damage to body organs. One~     medication used to treat sickle cell disease is hydroxyurea.~      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with~     sickle cell anemia. These include a reduction in the frequency of pain crises and acute~     chest syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients~     but HbSC patients were not included in the large clinical trials used to test hydroxyurea in~     SCD, so less is known about how HbSC patients respond to hydroxyurea.~      The purpose of this research study is to see if hydroxyurea, a medication given to many~     children with the most common type of sickle cell, those who are homozygous for the sickle~     mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by~     giving a questionaire when the medication is started, and then every two months at a clinic~     visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle~     Cell Disease Module version 3.0, measures quality of life. The investigators will also see~     how hydroxyurea changes laboratory test numbers, and blood thickness.~   "
55064|NCT02336360|"~     This study will obtain data from urine in subjects administered 18F-AV-1451 in an~     Avid-sponsored study to augment the calculation of radiation dosimetry estimates.~   "
55065|NCT02336347|"~     To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide~     [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady~     state.~   "
55066|NCT02336334|"~     Measuring and logging head positions of patients which underwent surgery with~     gasendotamponades.~   "
55087|NCT02336061|"~     The purpose of this study is to evaluate of gender differences on the psychosocial and~     economic impact in patients with advanced non-small cell lung cancer.~   "
55067|NCT02336321|"~     In this study, 6 volunteer participants with chronic spinal cord injury will be invited to~     use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction~     (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the~     intention of the user to grasp objects of daily life. The BNCI system consists of a~     lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a~     computerized control system integrated into a wheelchair. Before, during and after use of~     the BNCI system the volunteers will perform standardized assessments and complete~     questionnaires to assess the functional and psychological effects of the exoskeleton.~     Functional outcomes primarily focus on motor function in performing daily life actions while~     psychological outcomes primarily focus on safety, reliability as well as predisposition and~     perceptions of disability.~   "
55068|NCT02336308|"~     Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with~     keeping burn patients comfortable, especially when these patients undergo dressing changes~     of their burn wounds of their skin since these procedures often cause severe pain. Patients~     with burn wounds frequently require high doses of opioids (narcotics) and calming~     (anxiolytic) agents to the extent that clinicians must weigh the risks associated with these~     doses against achieving adequate analgesia and comfort. The biggest risk is over-sedation to~     cause breathing troubles. Inadequate pain control during these procedures heightens pain~     perception, anxiety, and fear surrounding the experience and may lead to patients~     experiencing additional psychological disorders like depression, acute stress disorder~     (ASD), and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better~     management of pain and anxiety during these procedures need to be identified.~      This study will address whether the addition of ketamine during dressing changes improves~     patients' pain control and comfort and whether this leads to favorable psychological~     outcomes. The study is designed to compare ketamine with placebo when they are added to~     usual care (opioids and anxiolytics) during dressing changes. The main outcomes of the study~     will be the amount of opioid and anxiolytic agents each group receives during their~     procedure; the presence of pain-related anxiety shortly after the procedures; blood markers~     of stress during the procedures; and the presence of depression, anxiety and stress~     disorders prior to discharge. This study will assess whether the early administration of~     ketamine reduces pain and anxiety to prevent the need for high doses of opioids and~     anxiolytics. A total of 30 patients will be enrolled.~   "
55069|NCT02336295|"~     The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for~     the vegan population in Israel. The participants will complete the FFQ, and the data will be~     verified by evaluating the participants energy expenditure (by measuring BMR, body~     composition and daily activity) and conducting a 24-hour food interview.~   "
55070|NCT02336282|"~     A common and potentially debilitating late effect of childhood cancer treatment is~     neurocognitive impairment, frequently in the domain of executive dysfunction, which can~     limit educational attainment, employment, and quality of life. Among the survivors of~     childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of~     executive function impairment has been shown as high as 58.8%, with moderate to severe~     impairment as high as 33.5%, and risk for impairment increased with time from diagnosis.~     Given the potential of pervasive impact of neurocognitive impairment on daily life,~     interventions directed at reducing neurocognitive dysfunction among childhood cancer~     survivors with long-term follow-up are needed. This study examines the potential feasibility~     and efficacy of a novel intervention to improve executive function.~      Primary Objectives:~        -  To evaluate the feasibility of a home-based intervention using Transcranial Direct~          Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL~          participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).~      Secondary Objectives:~        -  To estimate the efficacy of a tDCS intervention paired with cognitive training.~        -  To explore the short-term effect of tDCS on measures of executive function among adult~          survivors of childhood ALL participating in the SJLIFE protocol~   "
55071|NCT02336269|"~     Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of~     certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain~     genotypes is used as an aid in the selection of appropriate medications based on the~     individuals' specific genotype and should be used in conjunction with other clinical~     information. The results from this tests constitutes one parameter in a multicriterion~     medication selection process, encompassing both clinical and laboratory-based assessments.~   "
55072|NCT02336256|"~     Introduction: Any form of trauma, including surgery is known to result in oxidative stress.~     Single incision laparoscopy is a step forward towards almost scarless surgery. It is also~     expected to result in a lower degree of free radicals generation and faster normalization of~     the organism's antioxidant capacity.~      Aim: The aim of the study was to assess a number of plasma oxidative stress markers in~     patients operated due to inguinal hernia using typical totally extra peritoneal (TEP) and~     modified single incision laparoscopic surgery (SILS) methods.~      Material and methods: Thirty-two consecutive patients with no acute disease and severe~     chronic disorder, were qualified for inguinal hernia laparoscopic surgery. All were~     caucasian males, aged 24-69 and they underwent one of two surgical approaches: totally~     extra-peritoneal repair (TEP) and single incision laparoscopic surgery (SILS). TEP patients~     created Group 1 (n= 17) and SILS patients formed Group 2 (n= 17). Total antioxidant status~     (TAS) and thiobarbituric acid-reacting substances (TBARS) were determined in three time~     points: before, one day and four days after the laparoscopic surgery.~   "
55073|NCT02336243|"~     This study evaluates the effectiveness of maternal supplementation with Docosahexaenoic acid~     (DHA) early in pregnancy to reduce the incidence of deep placentation disorders: preterm~     birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth~     restriction. Half of the participants in early pregnancy will receive DHA 600 mg per day,~     while the other half will receive placebo. Investigators will study also the ability of DHA~     supplementation, early in pregnancy, to enhance invasion and transformation of spiral~     arteries by trophoblast, as deep placentation indicators.~   "
55123|NCT02335593|"~     The purpose of the study is to evaluate the effect of Zinc supplementation on health status~     of hemodialysis patients through measurement of the following before and after Zinc~     administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also,~     Evaluation of quality of life of hemodialysis patients before and after Zinc administration~     using Fatigue severity scale questionnaire.~   "
55074|NCT02336230|"~     The study plans to treat at least 60 pediatric subjects, male and female, between the ages~     of 2 months and 17 years inclusive with acute Graft versus Host Disease (aGVHD) following~     allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment~     with systemic corticosteroid therapy. Subjects may have Grades C and D aGVHD involving the~     skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or~     GI tract, with or without concomitant skin disease.~   "
55075|NCT02336217|"~     The purpose of this pilot study is to determine the utility of an algorithm for better~     glucose control in diabetic patients communicated via an App to help improve outcomes and~     reduce urgent care and ER visits as well as improve A1C and quality of life.~   "
55076|NCT02336204|"~     The increase of overweight and obesity in young Italian people, nowadays showed by several~     epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional~     knowledge.~      Thus the aim of our study was to investigate if different nutritional knowledge from could~     affect body composition and drinking habits of a cohort of local young people.~      104 healthy subjects (56 males and 54 females) were recruited using oral advertisements~     among the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto~     alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire~     on alcohol consumption and another one related to nutritional knowledge. Then anthropometric~     data were measured: height, weight, waist and hips circumferences, waist-hips ratio and~     skinfolds were evaluated for each subject and body fat mass was calculated.~   "
55077|NCT02336191|"~     A prospective Observational study including 50 living donor liver transplant recipients to~     monitor the graft functions through thromboelastometry~   "
55078|NCT02336178|"~     The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in~     subjects with hemophilia B in usual care settings in China.~   "
55079|NCT02336165|"~     This is an open-label, non-randomized, multicenter Phase 2 study of MEDI4736 with three~     non-comparative cohorts:~      Cohort A: 37 subjects with newly diagnosed unmethylated MGMT GBM will receive MEDI4736 every~     2 weeks in combination with standard radiotherapy.~      Cohort B: 30 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks as monotherapy.~      Cohort B2: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks + bevacizumab every 2 weeks (10 mg/kg).~      Cohort B3: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks + bevacizumab every 2 weeks (3 mg/kg).~      Cohort C: 17 bevacizumab-refractory subjects with recurrent GBM will receive MEDI4736 every~     2 weeks in combination with continued bevacizumab.~   "
55080|NCT02336152|"~     To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in~     maintaining peri-operative body temperature as forced air warming, during open low-back~     surgery of medium duration.~   "
55081|NCT02336139|"~     To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of~     treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic~     HCV infection and recent injection drug use.~   "
55082|NCT02336126|"~     This is a pilot study of a biopsychological intervention program for adolescent chronic~     fatigue syndrome. The program is related to cognitive behavioral therapy, which has been~     proven beneficial in this disorders, but includes other mental techniques, such as emotional~     control and metacognitive elaboration.~      The aim of this pilot study is to explore a) patients' experiences and b) possible positive~     effects on symptoms. We hypothesise that the intervention will be regarded feasible by the~     patients, and that fatigue score will improve during the intervention period.~   "
55083|NCT02336113|"~     Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs)~     when they are a part of the multidisciplinary treatment-team at hospital wards. However, in~     the Norwegian health care system, there is a lack of studies on the effect of pharmacist~     intervention on clinically relevant outcomes. Hospital readmissions has both clinical and~     economical negative effects, and time outside the hospital until an eventual readmission is~     considered as a clinical relevant outcome measure. We are conducting a randomized controlled~     trial at an internal medicine ward at Oslo University Hospital. 400 acute admitted patients~     using minimum 4 regular drugs from minimum 2 drug groups will be enrolled in the study.~     Patients randomized to the Control group will receive standard care (without a pharmacist~     involved) and patients randomized to the Intervention group will receive a pharmacist in~     their treatment team during the hospital stay. The study hypothesis is that including a~     pharmacist in the multidisciplinary treatment team at a hospital ward, will improve the~     patients drug treatment, hence lead to an increased time outside the hospital until an~     eventual readmission.~   "
55084|NCT02336100|"~     Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy~     were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were~     analyzed.~   "
55085|NCT02336087|"~     This pilot phase I trial studies the side effects of gemcitabine hydrochloride, paclitaxel~     albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a standardized~     dietary supplement in treating patients with pancreatic cancer that cannot be removed by~     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel~     albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer~     cells. Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium~     broccoli sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc~     amino chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in~     the cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine~     hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and metformin~     hydrochloride with a dietary supplement may work better in treating patients with pancreatic~     cancer that cannot be removed by surgery.~   "
55086|NCT02336074|"~     This study will be a two-arm prospective 1:1 randomised controlled trial comparing:~      Arm A: 4-drug cART including raltegravir (combination ART cART - control) Arm B: 4-drug cART~     including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv (MVA) boost~     vaccines; followed by a 28-day course of vorinostat (10 doses in total).~      We hypothesise that this intervention in primary HIV infection will confer a significant~     reduction in the latent HIV reservoir when compared with cART alone.~   "
55088|NCT02336048|"~     This multicenter, double-blind, randomized, placebo-controlled study will evaluate the~     safety of a single infusion of tocilizumab versus placebo, administered in addition to~     standard premedications (antipyretic, antihistamine, and corticosteroid) prior to the first~     infusion of obinutuzumab administered in combination with oral chlorambucil to participants~     with previously untreated B-CLL who have comorbidities. All eligible participants will be~     treated with a total of 6 cycles of obinutuzumab + chlorambucil (cycle length = 28 days).~   "
55089|NCT02336035|"~     Eligible patients that sign an informed consent will be randomized to operation with volar~     locking plate or cast immobilization. Primary follow-up after 1 year.~   "
55090|NCT02336022|"~     Pediatric postoperative patients are at increased risk for post-operative respiratory~     complications such as hypoventilation. There is no objective measure of early respiratory~     parameters that would predict respiratory compromise after surgery efficiently in pediatric~     patients. Current respiratory assessment in non-intubated patients relies on oximetry data,~     impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has~     been extremely helpful in recognizing oxygen desaturations but it is a late indicator of~     respiratory decline. New advances in technology and digital signal processing have led to~     the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM~     (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate~     real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation~     (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary~     hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV,~     RR and MV in pediatric patients.~   "
55091|NCT02336009|"~     Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with~     rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of~     movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty.~     Several implants are available on the market and they all have different pros and cons. One~     risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose,~     revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the~     likely alternative. Revision rates five years after the index operation have improved,~     however, they cannot yet compare with the results after a total hip arthroplasty. A newly~     designed TWA has been developed by the department of Hand Surgery, Örebro university~     Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers~     theoretical advantages and has been biomechanically tested at the Mayo clinic.~      This is a pilot study where patients operated with the TWA will be assessed pre and~     postoperatively according to study protocol in order to evaluate outcome after TWA~     radiologically, clinically and regarding patient perceived outcome measures.~   "
55092|NCT02335996|"~     Identifying hypercortisolism patients at risk for cardio-vascular events despite biological~     cure, and determine which patients should be particularly followed. Hypercortisolic patients~     represent an ideal in vivo model to determine the interactions between glucocorticoids and~     ectopic fat development.~   "
55093|NCT02335983|"~     The purpose of the study is to determine the maximum tolerated dose and assess the safety,~     tolerability and activity of a once-weekly regimen of carfilzomib in combination with~     lenalidomide and dexamethasone for the treatment of multiple myeloma.~   "
55094|NCT02335970|"~     This study evaluates the effect of a training intervention after thoracoabdominal resection~     of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery~     were randomized to an intervention group while the other half a control group.~   "
55095|NCT02335957|"~     The main purpose of this study is to show the non-inferiority of the incidental irradiation,~     as compared to intentional irradiation of the axillary nodes, in terms of 5-years~     disease-free survival (DFS) of early stage breast cancer patients with limited affectation~     of sentinel node assessed by OSNA (250 to 15,000 copies/uL), treated with~     breast-conservative surgery without axillary lymphadenectomy.~   "
55096|NCT02335944|"~     The study determines the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of~     EGF816 in combination with INC280 and to estimate the preliminary anti-tumor activity of~     EGF816 in combination with INC280 in patients with advanced non-small cell lung cancer~     (NSCLC) with documented EGFR mutation.~   "
55097|NCT02335931|"~     The project concerns a type of very debilitating diabetic foot complications called Charcots~     osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction~     of the load bearing joints, primarily in the feet, resulting in loss of structure and~     remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain~     and walking disability for the patient. Reconstruction is often very difficult or~     impossible, and furthermore the collapse can lead to chronic foot ulcers and infections,~     which in the worst case can be fatal.~      Treatment options are currently limited to early diagnosis and physical offloading~     (immobilisation), assisted wound healing and surgical intervention.~      The purpose of this project is to investigate and describe the bone-related factors, which~     separate COA from other, less acute, diabetic foot changes. The investigators wish to~     describe the long term consequences of COA - both anatomically, physiologically and~     biochemically.~      The investigators will be doing this in a follow-up investigations on a group of COA~     patients tested 8 years ago. Little is known of the long term changes to the bone structure~     after acute COA, and the investigators want to visualize to what extend the bone damage is~     permanent.~      To do this the investigators will be using DXA-scans, x-ray, blood tests including bone~     markers, neurophysiological tests and occlusion plethysmography.~   "
55098|NCT02335918|"~     This is a study to determine the clinical benefit (how well the drug works), safety, and~     tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558).~     Both drugs target the immune system and may act to promote anti-cancer effects.~   "
55177|NCT02334878|"~     This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress~     urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness~     or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are~     undifferentiated cells which can undergo self-renewal & differentiation into other cell~     types like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In~     this study mesenchymal stem cells will be obtained from bone marrow from the patient,~     processed, & then re-injected periurethrally. Effectiveness will be compared to that of the~     surgical treatment (tension-free vaginal tape).~   "
55099|NCT02335905|"~     This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline),~     which fights infections like the one the subject has. Ceftaroline is effective against~     S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus~     (MRSA.)~      Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in~     adults with Community-Acquired Bacterial Pneumonia [a type of lung infection] and Acute~     Bacterial Skin and Skin Structure Infections. Ceftaroline has been studied in children with~     both simple and complicated pneumonia but the FDA has not yet approved Ceftaroline for use~     in subjects less than 18 years of age. Therefore, the use of Ceftaroline in this research~     study is considered investigational.~      The goal of this research study is to find out what side effects there may be when children~     are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections~     due to Staphylococcus aureus in children. The investigators are also studying what the body~     does to the study drug, Ceftaroline, and if the doses the investigators use result in blood~     levels that the investigators think are going to be effective against bone infections in~     children. This is called pharmacokinetics (PK).~   "
55100|NCT02335892|"~     Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting~     multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12~     months.~   "
55101|NCT02335879|"~     The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant~     Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including~     polycystic ovarian syndrome [PCOS] subjects).~   "
55102|NCT02335866|"~     The main objective of this study was to evaluate the clinical effectiveness of platelet-rich~     fibrin membrane used in combination with a coronally advanced flap and to compare it with~     the use of a subepitelial connective tissue graft in combination with a coronally advanced~     flap in Miller class I-II bilateral gingival recession treatment~   "
55103|NCT02335853|"~     Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause~     afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for~     the development of overactive bladder.~   "
55104|NCT02335840|"~     Introduction: reduction of blood pressure after physical exercise is called post exercise~     hypotension (PEH). However, previous studies demonstrate that ingestion of caffeine~     equivalent to three tea-cup of coffee abolishes this phenomenon. Objective: evaluate the~     influence of different doses of coffee in PEH. Methods: eleven hypertensive performed four~     experimental sessions of aerobic exercise in cycle ergometer (40 minutes of duration,~     intensity between 60% and 80% of maximum heart rate) succeeds for the ingestion of one~     (CAF-1), two (CAF-2), three (CAF-3) doses of caffeinated coffee (144 mg/dose), or three~     doses of decaffeinated coffee (DESC). Blood pressure was measured in rest and during 120~     minutes of recovery post exercise, each 10 minutes.~   "
55105|NCT02335827|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable renal tumors.~   "
55106|NCT02335814|"~     This first-in-human (FIH) clinical trial is a Phase 1/1b, open-label, sequential-group,~     dose-escalation and cohort expansion study evaluating the safety, PK, PD, and antitumor~     activity of FLX925 in subjects with relapsed or refractory AML.~   "
55107|NCT02335801|"~     The objective of this study is to determine whether the presence of metabolic alteration and~     anabolic deficiencies in patients with chronic heart failure are able to identify a subset~     of patients with poor outcome.~   "
55108|NCT02335788|"~     This is an open label, acute, non-randomized, prospective, first in man (FIM)~     single-center study of the EMBA Medical Peripheral Embolization Device (PED).~   "
55109|NCT02335775|"~     The purposes of this study are to determine whether total lymph node count or the percentage~     of identified nodes with metastatic disease are influenced by (1) the method of categorizing~     tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.~      Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine~     carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study.~     Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per~     the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the~     extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients~     will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one~     side divided into specific basins, and on the contralateral side classified only as pelvic~     or aortic. Surgical node specimens in the operating room will be labeled by (1) specific~     nodal basins on the randomly determined side as external iliac, obturator, common~     iliac, aortic, or high aortic and by (2) pelvic versus aortic (common iliac nodes~     will be considered as part of the pelvic specimen) on the contralateral side.~   "
55110|NCT02335762|"~     40 healthy subjects were recruited using advertisements posted at the Catholic University of~     Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a~     Gima scale) of each subject were measured and the body mass index (BMI) was calculated~     (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all~     food and drink consumed daily for 3 days using a diary previously used in the Italian~     National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate~     as best their habits. They were educated to report also the place, time, number and quantity~     of serving portions consumed. If they were not able to weight exactly each portion, a~     photographic atlas developed for the Italian component of the European Prospective~     Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days~     the food diaries were checked and for each subject the energy intake was estimated.~   "
55111|NCT02335749|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area~     applicator for non-invasive subcutaneous fat reduction in the distal thigh.~   "
55112|NCT02335736|"~     The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF)~     patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal~     females undergoing IVF. Can it be used with the same efficacy in all patients?~   "
55113|NCT02335723|"~     The primary objective of this clinical investigation is to investigate the feasibility and~     possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with~     presumed endotoxemia of abdominal or urogenital origin.~   "
55114|NCT02335710|"~     Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty~     was analyzed by the Center for Musculoskeletal Research in a past research study, and it was~     determined that subjects experienced more normal-like kinematic patterns. They also achieved~     excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew~     has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty~     (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the~     revised design to determine if subjects experience normal-like kinematic patterns and if~     greater weight-bearing knee flexion is achieved. The objective for this study is to analyze~     the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and~     compare those patterns to subjects having a normal knee and those having the 1st generation~     Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.~   "
55115|NCT02335697|"~     Female circumcision (FC) causes both immediate and long-term health consequences. In~     general, the more severe type of FC, the worse health consequences can be seen. Despite the~     negative health effects, the practice of FC is still found to be highly prevalent in many~     countries, mainly in Africa and the Middle East. Many studies have been performed on FC in~     African countries where the custom is widespread and there have also been many attempts to~     eradicate the practice in these countries. However, considerably less research exists on FC~     in non-practicing societies where there has been an influx of immigrants from countries that~     traditionally carry out this practice. Further, no anti-FC interventions designed using a~     comparison group have been performed in any country outside Africa.~      This cluster randomized controlled trial aims to evaluate the effectiveness of a~     community-based participatory intervention on changing attitudes towards FC among newly~     arrived Somali immigrants in Sweden. Included in the research is an assessment of the~     acceptability of the intervention. Based on social convention theory, we hypothesize that an~     interaction between established Somali immigrants, thought to be predominantly opponents of~     FC, and newly arrived Somali immigrants will facilitate changes in attitudes among the newly~     arrived.~      The trial will be implemented in two municipalities in Sweden that have a high proportion of~     Somali immigrants. Somali organizations in these municipalities will constitute the~     clusters. In total, 8 clusters will be included, 4 intervention clusters and 4 control~     clusters.~   "
55116|NCT02335684|"~     This randomized trial has been designed to study if it is possible to enhance work capacity~     during submaximal efforts in heart failure patients supported with continuous-flow left~     ventricular assist devices (CF-LVAD).~      The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD~     patients can be increased when pump speed is increased soon after the onset of exercise.~   "
55117|NCT02335671|"~     The purpose of this study is to investigate the use of intra-operative Magnetic Resonance~     Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine~     if these tests are capable of accurately predicting the presence or absence of breast tumor~     in surgical specimens at the margins.~   "
55118|NCT02335658|"~     The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.~   "
55119|NCT02335645|"~     This case series will follow standard ACL protocol, while using biomechanical movement~     analysis to analyze running mechanics using a body weight supported treadmill.~      Standard ACL protocol will be followed throughout the treatment of each patient. The only~     variance from treatment will be using motion analysis software to analyze gait patterns at~     different points throughout the rehabilitation.~      The first motion analysis will be performed at week 6 of the rehabilitation process. Prior~     to this treatment, manual muscle testing of the hip, knee and ankle using a handheld~     dynamometer, two outcome measures, range of motion, pain, and patient satisfaction will be~     performed. At this treatment, motion capture sensors will be placed on the patient at~     different anatomical positions. The patient will then run in a body weight supported~     treadmill. During this run, video capture will be performed and later analyzed to determine~     biomechanical kinematics.~      This process will be repeated at week 8 of rehabilitation in the body weight supported~     treadmill.~      At week 10, the patient will shift treatment from the body weight supported treadmill, to a~     standard treadmill. The process will be repeated using the same anatomical landmarks and~     video capture.~      The final video capture will be performed at week 12. At this visit, video capture will be~     performed. The patient will also repeat all test, measures, and questionnaires from week 6.~      At all visits between video capturing, standard PT will be performed with a focus on patient~     deficits and following the standard protocol.~   "
55120|NCT02335632|"~     Background/Aims:~      The investigators explored the therapeutic effects of probiotics in patients with AH.~      Methods:~      Between December 2012 and January 2015, the investigators conducted a 7-day,~     double-controlled, randomized, prospective clinical trial comparing the efficacy of~     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and~     stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as~     an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST~     (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to~     receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or~     placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and~     pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing~     gradient gel electrophoresis were checked at baseline and again after therapy.~   "
55121|NCT02335619|"~     Currently at the BC Cancer Agency, oncologists decide when to refer a patient to the Pain~     and Symptom Management/Palliative Care (PSMPC) team, and their decisions are made~     subjectively and without standard guidelines/symptom assessment tools. Patients are often~     referred late in their treatment. The PSMPC team sees patients in their own clinic,~     separately from the oncologists, and do not often collaborate in a patient's care.~      Early integration of palliative care into oncological care has been shown to improve quality~     of life and to prolong survival, as well as to reduce inappropriately aggressive oncological~     care at end of life, and reduce costs of care. We will test an early oncology-integrated~     palliative care model, with the aims of determining whether 1) the introduction of PSMPC~     support at the time of diagnosis leads to better symptom management and quality of life of~     patients, 2) early integration of palliative care into medical oncology care reduces~     aggressiveness of cancer treatment near end of life, and 3) a fully integrated service~     delivery model is sustainable.~   "
55122|NCT02335606|"~     Abatacept Registry in Taiwan~   "
55124|NCT02335580|"~     The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%.~     Current evidence regarding the effect of portal vein thrombosis on the prognosis of~     cirrhotic patients remains under debate. Considering that PVT potentially elevates the~     portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients~     with high-risk varices and variceal bleeding as the study population. Thus, the main goals~     are to analyze the effect of PVT on the incidence of first variceal bleeding in patients~     without any prior bleeding history but with high-risk varices, the incidence of recurrent~     variceal bleeding in patients with a history of variceal bleeding, and the treatment failure~     rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival~     is also observed in all patients.~   "
55125|NCT02335567|"~     To compare two competing newly designed 3D sequences for black blood carotid plaque imaging~     techniques with the industry standard 2D sequnce for black blood.~   "
55126|NCT02335554|"~     Depression is one of the most prevalent mental disorders to afflict adults. It seriously~     impacts role functioning and often takes a recurrent or chronic course. Because most adults~     who suffer from depression never receive treatment, there is a critical need to develop~     interventions that can be easily implemented and widely disseminated. Interventions that~     reduce the performance-impairing symptoms of subclinical depression and prevent the onset of~     major depression can improve employee well-being, while reducing healthcare costs and~     improving productivity. This project produced a mobile-web program to activate cognitive~     behavioral skills in workers with subthreshold depression, reduce depression symptoms,~     improve functioning in the workplace, and potentially reduce the risk for escalation to~     full-syndrome depression.~   "
55127|NCT02335528|"~     SimCoach, a computer program featuring a virtual human that speaks and gestures in a~     videogame-like interface, is designed to encourage servicemembers, especially those with~     signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to~     improve their psychological health. The assessment included a formative component assessing~     SimCoach's design, development, and implementation approaches, as well as a summative~     component assessing outcomes among participants in a user experience survey and a randomized~     controlled trial (RCT).~   "
55128|NCT02335515|"~     The primary objective of the study was to assess the gastric residence time (GRT) of the~     Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial~     screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that~     the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer~     compared to literature values reported for a simliar sized capsule.~   "
55129|NCT02335502|"~     04-SMI-2012 is post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic, intractable pain.~   "
55130|NCT02335489|"~     14-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     neuropathic pain of the foot and/or lower limb~   "
55131|NCT02335476|"~     The investigators will use optical coherence tomography to detect the ex-vivo tissue image~     of surgical removed melanoma or other benign pigmented lesions of skin.~   "
55132|NCT02335463|"~     The investigators will use an advanced high resolution 3D optical coherence tomography (OCT)~     technology to observe colon and skin images in ex vivo.~   "
55133|NCT02335450|"~     This study evaluates the effectiveness of personalized physical activity coaching combined~     with the use of a physical activity monitor to support increased levels of daily physical~     activity in individuals with multiple sclerosis. All five participants will receive the~     intervention over the four week intervention phase.~   "
55134|NCT02335437|"~     Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting~     fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms.~     Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents~     undergoing acute EBV infection will be followed prospectively, and also compared with a~     group of healthy controls. The aim is twofold:~        -  To identify factors that predispose to chronic fatigue among adolescents with acute EBV~          infection~        -  To compare pathophysiological features of patients with acute EBV infection with a~          group of healthy controls.~      Possible risk factors for chronic fatigue 6 months after EBV-infection includes:~        -  Severity of the initial infection~        -  Immune responses characteristics~        -  Characteristics of the neuroendocrine stress response~        -  Cognitive functioning~        -  Emotional disturbances~        -  Genetics/ epigenetics of candidate genes~        -  Certain personality traits~        -  Critical life events~   "
55135|NCT02335424|"~     This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of~     participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are~     ineligible for cisplatin-based therapy. The primary study objective is to determine the~     objective response rate (ORR) in all participants, in participants whose tumors rely on~     programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants~     with strongly PD-L1-positive tumors.~   "
55136|NCT02335411|"~     This is a study of pembrolizumab for advanced gastric or gastroesophageal junction~     adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had~     previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as~     combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in~     treatment-naïve participants. The primary study hypothesis is that pembrolizumab will~     provide a clinically meaningful overall response rate.~   "
55137|NCT02335398|"~     Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in~     pain management. However, methadone usage for pain control in Thailand has been limited~     because physicians are not familiar with its dosing and concern about the risk of drug~     accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to~     evaluate the efficacy and safety of a methadone protocol in Thai patients with severe~     chronic noncancer and cancer pain.~   "
55189|NCT02334722|"~     The purpose of this study is to see if there are any differences between patients who~     receive Levetiracetam extended-release tablets for one week after surgery to remove a brain~     tumor versus those who receive Levetiracetam extended-release tablets for six weeks after~     surgery. Specifically, we will see if one group has less side effects than the other, and~     whether or not one group has more seizures than the other.~   "
55138|NCT02335385|"~     Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of~     varicocele in our department since the nineties. However, the relatively several trocar~     wounds represent a big challenge against its acceptance by many of our patients who prefer~     the open approach with one or at least two wounds.~      Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven~     to be feasible and effective, with high patient satisfaction rates regarding improved~     cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10,~     11) SILS for varicocelectomy has been reported to be safe and effective alternative to~     conventional laparoscopic varicocelectomy in a few studies.~   "
55139|NCT02335372|"~     Objectives:~      Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for~     detection of cervical neoplasia in Brazil.~      Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate~     the highest degree of correlation with disease state.~   "
55140|NCT02335359|"~     The purpose of this study is to determine whether tranexamic acid is effective in reducing~     intraoperative blood loss and necessity for haemotransfusion in patients undergoing open~     abdominal aortic aneurysm repair~   "
55141|NCT02335346|"~     The purpose of this study is to assess the safety and efficacy of duloxetine in participants~     with osteoarthritis and knee pain. The study will last for 1 year.~   "
55142|NCT02335333|"~     The primary purpose of this study is to measure the correlation between baseline expression~     of aging biomarkers, SenesceTest in blood of organ donor and renal graft function. This~     pilot study will study patients who are undergoing renal transplantation with organs from~     extended criteria donors, standard criteria donors or donation after cardiac death and~     compare ability of SenesceTest to predict renal graft function immediately after the~     transplant and at 1 year followup.~   "
55143|NCT02335320|"~     Acute or chronic HCV infection can lead to liver complications, including liver failure,~     cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical~     question remains the terms of treatment initiation. In Europe, new treatments are available~     since the approval of three direct acting antivirals. However with the high cost of these~     treatments, they are currently only available for critically ill patients. Other molecules~     are currently in advanced clinical development phases. The use of clinical predictors~     remains relevant for the selection of a suitable treatment for each patient, in particular~     to limit the adverse effects and reduce costs. Currently the quantification of viral load is~     a measure of response to treatment; with the recommendation to stop treatment in patients~     who fail to achieve an undetectable level of viral load. Genetic factors have also been~     identified as predictors of response to treatment, in particular polymorphisms of the IL-28B~     gene. Genotyping of this gene is currently performed using classical PCR amplification~     applied to DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this~     protocol to test a non-invasive method and rapid test for IL-28B genotype which could be~     used for point of caring testing, and ultimately better patient management.~      This is a monocenter, cross-sectional study among HCV chronic patients. The study will be~     conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris,~     France).~      Objectives The principal objective is to assess the accuracy of the newly developed~     Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the~     genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay~     as gold standard.~      The secondary objective is to assess the concordance between the genotype results of the~     Genedrive and the gold standard regarding the three genotypes CC, CT and TT.~   "
55144|NCT02335307|"~     This study will examine the effect of having genotype information on pain management and~     pain control for patients treated in family medicine clinics. This study will also examine~     physician-perceived usefulness of genotype information. Patients will be enrolled from~     family medicine clinics serving as either implementation sites or control sites. Patients~     from implementation sites will undergo genotyping, while those from control sites will not~     by genotyped.~   "
55145|NCT02335294|"~     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with~     placebo in patients with acute postoperative pain following abdominoplasty.~   "
55146|NCT02335281|"~     There are many limitations in the current treatments of Inflammatory bowel disease (IBD).~     Now the investigators realized that the intestinal microecological is closely associated~     with the development of IBD. So the standardized fecal microbiota transplantation is~     considered to be simple but effective emerging therapies for the treatment of IBD. In this~     project the investigators intend to carry out a single-center, randomized, single-blind~     clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases~     of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be~     randomly divided into 2 groups, one group will be given treatment of standardized fecal~     microbiota transplantation, the other will be simply treated with mesalazine, followed up~     for at least 1 year. The investigators propose to determine the efficiency, durability and~     safety of Standardized Fecal Microbiota Transplantation for IBD treatment.~   "
55147|NCT02335268|"~     There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients~     classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS~     found that baseline concentration of TPO as well as transfusion history were predictive of~     subsequent response in a retrospective model. The current prospective study has the aim to~     explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion~     history) can predict the response to subsequent short-term treatment with romiplostim.~   "
55148|NCT02335255|"~     To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to~     Naftin® (Naftifine Hydrochloride) Gel 2%~   "
55149|NCT02335242|"~     A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or~     resolve lymphatic malformations in children. Subjects may receive either placebo or~     treatment in an oral dosage with an open label extension for subjects who received placebo.~     The study treatment assignment will be randomized in a double blind fashion. MRI examination~     will evaluate change in lesion volume due to treatment. Other safety and efficacy measures~     will be taken through the 32-week study duration.~      Funding Source - FDA OOPD~   "
55150|NCT02335229|"~     20-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic post surgical pain~   "
55151|NCT02335216|"~     18-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)~   "
55226|NCT02334241|"~     The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of~     using Sorbact® dressing technology in addition to best local cares compared to best local~     cares alone in the management of diabetic foot ulcers~   "
55152|NCT02335203|"~     Objective: To compare pre- and post-treatment glandular cellularity in women with complex~     atypical hyperplasia or grade 1-2 endometrial adenocarcinoma who are treated with~     intramuscular depot medroxyprogesterone acetate (DMPA) versus placebo injection prior to~     hysterectomy. The secondary objective is to compare various other outcomes including~     molecular, histologic, pathologic and clinical endpoints in women treated with DMPA versus~     placebo prior to hysterectomy.~      Hypothesis: Patients treated with DMPA will have significantly decreased glandular~     cellularity post-treatment when compared to patients treated with placebo injection.~     Patients treated with DMPA will exhibit previously described changes in molecular tumor~     marker expression patterns and other characteristic histologic changes. Patients treated~     with DMPA will report less bothersome vaginal bleeding prior to surgery when compared to~     patients treated with placebo injection.~      Study Design: Double blinded randomized controlled trial~      Population: Women being treated at the Women and Infants Program in Women's Oncology who~     have a biopsy-proven diagnosis of complex atypical hyperplasia or grade 1-2 endometrial~     adenocarcinoma with disease clinically confined to the uterus, with a plan to undergo~     hysterectomy.~      Study Period: February 2015 to June 2016~   "
55153|NCT02335190|"~     The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA)~     can be used to treat low back pain from the SI joint , and is often recommended by~     physicians to provide long lasting pain relief. However, the use of RFA for SI joint pain~     has not been as successful as RFA for pain in other areas of the back and neck. X-ray~     guidance (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy,~     however, it can be difficult for physicians to identify necessary landmarks, and there are~     risks to the patient because of radiation exposure. In contrast, ultrasound may provide~     better image guidance than fluoroscopy, and there is no radiation risk. The purpose of this~     study is to examine if ultrasound guided SI joint RFA is effective.~   "
55154|NCT02335177|"~     After hospitalization, elderly people are still at risk for falling at home. The objective~     of the study is to evaluate at home after hospitalization the impact of an intervention for~     3 months combining technologies for autonomy and tailored physical activity program. The~     study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics~     hospital and with a loss of autonomy requiring physiotherapy and home support workers. It is~     a prospective, randomized, single-center, in cluster study which compares a Patient group~     (interventional group) with the intervention program (technologies + physical activities)~     with a control group benefiting from usual care home. Our hypothesis is that in the~     interventional group fewer falls were observed and improved different scores (Timed Up and~     Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the~     control group.~   "
55155|NCT02335164|"~     Recombinant hemagglutinin has been shown to induce protective neutralising antibodies~     against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian~     influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant~     to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and~     efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant~     formulations administered by intramuscular injection~   "
55156|NCT02335151|"~     Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor~     removal of pancreatic cancer will be determined and correlated to the accordance of~     anesthesia (desflurane versus propofol)~   "
55157|NCT02335138|"~     The proposed research aims to address the question: Compared to the current standard of care~     for home-based HIV tests, in which persons conduct and interpret HIV tests without~     counseling, does the addition of video conferencing with a remote counselor increase~     health-enhancing, protective behaviors among male-male couples and facilitate linkage to~     care for those who test positive?~   "
55158|NCT02335125|"~     The goal of this pilot study is to develop and implement a larger scale, multi-site stepped~     collaborative care trial that targets injured patients with presentations of Posttraumatic~     Stress Disorder (PTSD) and related comorbidity.~   "
55159|NCT02335112|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Head and Neck Neoplasms.~   "
55160|NCT02335099|"~     This study is a randomized, placebo-controlled, single blind clinical trial. Seventy~     patients with ESRD on chronic HD and a functioning AVF will be recruited. The following data~     will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of~     HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access~     5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery~     disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current~     medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets,~     digoxin, statins). Patients will be randomized into two groups to receive: Group 1:~     Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.~   "
55161|NCT02335086|"~     The purpose of this study is:~        1. To examine the association between stable and unstable coronary artery disease (CAD)~          with markers of DNA damage and repair,~        2. To examine the association between plaque morphology as assessed by frequency-domain~          optical coherence tomography (FD-OCT) and markers of DNA damage and repair in order to~          identify potential markers of plaque instability,~        3. To examine the association between markers of DNA damage and repair and major adverse~          cardiovascular events defined as death, MI and unplanned percutaneous or surgical~          revascularization,~   "
55162|NCT02335073|"~     Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many~     limitations, such as sampling error and individual variation in interpreting the results.~     Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of~     liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN),~     hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III~     (PIIINP). However, few study was conducted to explore the role of these liver fibrosis~     markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV,~     and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.~   "
55163|NCT02335060|"~     The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the~     acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating~     healthy individuals with NAC and then assessing their responses to THC.~   "
55164|NCT02335047|"~     Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the~     psoas muscles, even when the subject has been told not to contract any muscles. The psoas~     contraction is involuntary and cannot be controlled by the subject. This lack of passivity~     might be concomitant with lower back pain: the impairment may be present when lower back~     pain is present and/or absent when lower back pain is absent.~      The study's primary objective is thus to determine the sensitivity and/or specificity of a~     clinical test for impaired hip flexor passivity in cases of lower back pain during passive~     flexion of the trunk (from the supine position,).~      The secondary objective is to show that a negative test (after administration of correcting~     measures) is correlated with a decrease in pain (i.e. pain intensity and the functional~     repercussions of pain).~   "
55165|NCT02335034|"~     OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a~     multidisciplinary care program with and without associated classroom educational program.~     METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of~     Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical~     rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2~     groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist -~     assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric~     parameters and diet quality. Social Worker - Level of education, religion, autonomy and~     mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and~     quality of life. Occupational Therapy - range of motion and strength. Physical Educator -~     level of physical activity and functional capacity. Orthopaedic - additional examinations,~     disease classification, orthotics, report to Social Security and Traffic Department,~     evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy,~     physical activity and inform consent. A group will submitted to two interventions, with an~     interval of two months between each intervention. The control group will only make~     evaluations / consultations with all professional teams without classes for 2 years, then~     will attend the courses and will be followed by two more years. Interventions will be~     lectures and practices with the seven professional teams, covering the topic arthritis~     (orthopedic team), what is disease, being ill, and the role of the patient in the treatment~     (psychology) to obtain behavioral change. Lectures and practices with physical therapy and~     occupational therapy to show the importance of exercise in relieving symptoms (physical~     therapy), the importance of rest and proper ergonomics at home and at work (occupational~     therapy). The nutritionist shows proper alimentation. Lecture and practice with physical~     educator (showing the difference between the laber work and regular physical activity as~     well as the importance of strength exercises, resistance and stretching) and theoretical~     class with the social service by calling attention to the importance of leisure. After two~     months, the second intervention is made in order to verify the acquired concepts. Six~     months, 1, 2, 3 and 4 years after the first evaluation, the groups will be called to new~     multi evaluation.~   "
55166|NCT02335021|"~     The purpose of this study is to investigate the effects of dietary exposure to artificial~     sweeteners on taste sensitivity, preference and brain response in adults. The investigators~     hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease~     sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and~     reduce brain response in amygdala to sweet taste compared to sucrose.~   "
55167|NCT02335008|"~     The goal of this study is to test the hypothesis that repeated consumption of artificial~     sweetener reduces sweet taste intensity.~   "
55168|NCT02334995|"~     Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves~     dissynegy and heals soliter rectal ulcer.~   "
55169|NCT02334982|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-137~     when administered as a single dose of tablets at escalating dose levels in healthy~     participants.~   "
55170|NCT02334969|"~     The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the~     secondary prevention of ischemic stroke by the multi-center,~     randomized,double-blind，placebo-controlled trial design project.~   "
55171|NCT02334956|"~     120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls~     will be administered a whole-brain imaging exam. The current research project constitutes a~     highly novel approach to understanding the pathophysiology of addiction through its~     combination of neuroimaging with state-of-the-art information concerning the real-time~     expression of risk factors.~   "
55172|NCT02334943|"~     Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral~     treatment. This immune activation is responsible for immune deficiency as well as for~     non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic~     syndrome or osteoporosis. The goal of this observational transversal multicentric study is~     to establish the etiologic factors of persistent immune activation in treated HIV-1 infected~     patients (persistent de novo infection of T CD4+ cells, microbial translocation, active~     coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different~     forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes,~     granulocytes, platelets, endothelial cells or general inflammation) and the potential~     correlation between causes, forms of immune activation and emergent comorbidities (kidney,~     bone or liver dysfunction, metabolic syndrome).~   "
55173|NCT02334930|"~     PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological~     similarities were seen between PEComa and infantile hemangioma. Propranolol is highly~     efficient to treat infantile hemangioma and we believe that this drug can also be useful for~     the treatment of PEComa.~      Purpose : to understand the mechanism of action of propranolol in PEComas and related~     pediatric vascular lesions and to select possible novel targets of betablockers in vascular~     tumors related to PEComas by using YAP oncogene activation as a molecular marker~   "
55174|NCT02334917|"~     This study is being carried out to assess equivalence of scar outcome for two absorbable~     sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable~     polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important~     because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet~     there is no evidence indicating if any of the sutures above allow for a better cosmetic~     outcome (less erythema, edema, and scarring).~   "
55175|NCT02334904|"~     Significant changes in brain morphology are observed in people with first-episode psychosis.~     Studies have shown that total brain volume and particular brain structures are decreased in~     people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic~     drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure~     changes in brain morphology in subjects recently diagnosed with bipolar or psychosis~     disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone.~     Secondary objectives include taking blood samples for fasting metabolic indices and~     neuropsychiatric measures for comparisons between drug treatments.~   "
55176|NCT02334891|"~     The purpose of this study is to investigate the patient characteristics, selection of~     treatment, and factors associated with clinical outcomes in Japanese patients with acutely~     decompensated congestive heart failure.~   "
56299|NCT02320201|"~     To determine the effects of electrical stimulation of the nerves in the foot on overactive~     bladder conditions in children.~   "
55178|NCT02334865|"~     This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete~     Freund's adjuvant together with sargramostim in treating patients with newly diagnosed~     multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from~     survivin peptide may help the body build an effective immune response to kill cancer cells~     that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune~     response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may~     increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine~     in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide~     maintenance therapy may be a better treatment for multiple myeloma.~   "
55179|NCT02334852|"~     The AF is the most common arrhythmia in clinical practice affecting 1-2% of the general~     population. It is the most common cause of cerebrovascular events (CVE), responsible for 25%~     of all ischemic strokes and 50% of cardioembolic strokes.~      The CARMEN-AF registry is planned to be the first registry of non-valvular AF in Mexico with~     national representation, planning and specific objectives for publications. Follow-up period~     of two years is planned.~   "
55180|NCT02334839|"~     Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as~     new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists~     regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse~     results are found compared to healthy gravidas. Thus, we aimed to assess endothelial~     function using PAT plethysmography in women with PET and compare their results to both~     healthy gravidas and those with only gestational hypertension.~   "
55181|NCT02334826|"~     The purpose of the study is to investigate the extent of ischemia and left ventricular~     function in cardiovascular magnetic resonance (CMR), as well as patency of coronary arteries~     and grafts in coronary computed tomography angiography at 12 months follow up in patients~     with advanced coronary artery disease treated with percutaneous coronary intervention with~     the implantation of bioresorbable scaffolds or coronary artery bypass graft surgery.~      Additionally, the clinical results of the two methods of revascularization will be carried~     out annually up to 5 years.~   "
55182|NCT02334813|"~     Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1~     between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and~     six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary~     endpoint is duration of remission defined as platelets ≥50/nl.~   "
55183|NCT02334800|"~     This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose~     of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and~     severely impaired hepatic function.~   "
55184|NCT02334787|"~     To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%,~     or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a~     multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.~   "
55185|NCT02334774|"~     Endotracheal intubation may contribute to the difficulties in swallowing and subsequent oral~     intake. Estimated 62% of patients who had been intubated ≧48 hours will experience~     post-extubation dysphagia. Clearly, intervention is needed but studies are lacking in this~     regard. Thus, the objective of this pilot trial is to evaluate effects of an Oral Swallowing~     Care Program on swallowing and oral intake status in patients following prolonged~     endotracheal intubation.~      This study employs a before-and-after intervention design. We will enroll 80 post-extubated~     adult patients (50 years old and older) who had prolonged (≥48 hours) oral endotracheal~     intubation from six medical intensive care units at a medical center in Taipei, Taiwan.~     Participants will be assessed within 48 hours post-extubation for the baseline data, then a~     14-day, daily Oral Swallowing Care Program involves moisturizing and cleansing oral cavity,~     massaging salivary gland, oral motor exercise, and intake education will be provided.~     Outcome will be assessed on 7th, 14th, and 21st day post-extubation including oral health~     status, oral sensation (stereognosis, light touch and two-point discrimination), tongue and~     lip strength, salivary secretion, body weight. In addition, Three-Step Swallowing Screen~     (3-SSS) and Functional Oral Intake Scale will be assessed daily. The data will be analyzed~     by SAS 9.3 software package.~   "
55186|NCT02334761|"~     Over the past decade the paradigm of care in oncology has evolved with the advent of~     personalized medicine. Yet, despite this exciting prospect, there are currently only a few~     disease subtypes where therapeutic approaches with proven benefit exist such as EGFR~     targeted therapies in EGFR-mutant lung tumours. With the increasing number of novel~     molecularly targeted agents available, the importance of building our understanding of~     cancer biology is critical.~      Challenges to implement personalized medicine include the limitations of molecular testing,~     tumour heterogeneity and molecular evolution, costs, and the quality and morbidity~     associated with tumour biopsies. Sequential biopsies are essential to better understand~     biological markers of response and resistance, and identify predictive or prognostic~     markers. Despite the scientific rationale for biopsies, incorporating them into practice can~     be challenging, as in many cases there is no direct advantage to the patient. This project~     aims to understand the effect of research biopsies on the patient. The Investigator~     hypothesize by learning more and gaining a better appreciation of the impact on the patient,~     Investigators will increase the likelihood of achieving serial biopsies.~      The ability to obtain serial biopsies is dependent on the patient's experience. To~     understand the clonal progression of cancer and validate predictive and prognostic markers~     of response, studies now target biopsies both at enrollment and at progression. As~     Investigators strive to achieve this, improving our understanding of the patient's~     experience will help us identify factors that positively and negatively impact on patient~     participation and influence the probability of successfully obtaining sequential samples.~   "
55187|NCT02334748|"~     The objective of this extension protocol is to collect safety data and to provide continuous~     Ilaris® (canakinumab) to patients in France who completed study CACZ885G2301E1 for a maximum~     of 24 months or until a decision regarding reimbursement in France is effective for Ilaris®~     in the SJIA indication.~   "
55188|NCT02334735|"~     Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but~     have minimal toxicity or lasting immune effects on their own. This study investigates the~     use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to~     Montanide® in study subjects with melanoma in complete clinical remission.~   "
55190|NCT02334709|"~     Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with~     metastasized renal cell carcinoma. In addition to their ability to specifically inhibit~     tumor growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most~     patients do not obtain long-lasting clinical benefit from this treatment. The goal of the~     current study is to enhance the effect of TKIs by combining them with stereotactic~     radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to~     precisely irradiate the tumor with minimal effect on the surrounding healthy tissue.~     Recently it has been demonstrated that this type of radiotherapy stimulates the immune~     system to attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to~     observe a reduction of metastases in a bigger population of patients.~      In the first part of our study we focus on the safety of the combination therapy. In the~     second part we will evaluate the combined treatment response.~   "
55191|NCT02334696|"~     The IMPROVA study is designed to identify novel predictors of vascular access success or~     failure. Clinical assessment complimented by Doppler ultrasound is the only currently~     employed methods of assessing suitability for placement of arteriovenous fistulae (AVF).~     These techniques are not capable of predicting vascular access outcomes suggesting that~     other potentially measurable factors may play a part.~      Despite efforts to improve placement of AVF in both the haemodialysis incident and prevalent~     population, many patients continue to dialyse through a central venous catheter (CVC),~     exposing them to higher risks of infection, co morbidity and mortality than dialysing via an~     AVF. Furthermore, AVF primary failure rates are reportedly as high in 20-50% in published~     series confirming that ultrasound cannot inform the clinician sufficiently to accurately~     predict success or failure.~      The aim of this study is to perform enhanced assessments of arterial health preoperatively~     and correlate these measurements with early AVF outcome. We intend to perform pulse wave~     analysis and velocity; measure advanced glycation end products and assess endothelial~     function using a vascular occlusion test. We also aim to assess whether patient reported~     symptoms of hand function can predict AVF outcome. These non-invasive measurements will~     provide a more accurate picture of overall vascular health prior to AVF formation with the~     ultimate intention of informing the clinician as to the likelihood of success or failure.~   "
55192|NCT02334683|"~     This study seeks to compare the use of ultrasound and electrophysiologic techniques to~     target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose~     of this study is to investigate the use of two ways of locating the muscle for botulinum~     toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity.~     Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard~     ways of locating muscles during a treatment of BoNT injection.~   "
55193|NCT02334670|"~     It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV~     care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100~     cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with~     high-dose fluconazole, and improve survival.~   "
55194|NCT02334657|"~     Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial~     aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source~     can be identified despite of repetitive radiological imaging. Patients, at least 18 months~     after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining~     the study purpose and the postal questionnaire consisting a short-form health survey with 36~     simple questions. If we didn't receive answers after three months we made telephone~     interviews with the patients' family members or their general practitioner.~   "
55195|NCT02334644|"~     This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with~     primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota~     composition in these patients.~   "
55196|NCT02334631|"~     Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine~     the small bowel. Although the procedure is useful for diagnosing small bowel diseases, air~     bubbles can obscure the recorded images. Simethicone is a medication that can be used to~     disperse the air bubbles. However, prior studies using this medication have shown only a~     modest benefit. In our study, we would like to investigate whether increasing the amount of~     medication will improve the recorded images further.~   "
55197|NCT02334618|"~     The purpose of this study is to use a novel load monitoring technology to correlate limb~     loading to ankle fracture outcomes. This study will collect continuous limb loading data and~     will provide the first objective insight into how limb loading directs fracture healing.~   "
55198|NCT02334605|"~     Nasal hyper reactivity is defined as an increased sensitivity of the nasal mucosa to stimuli~     such as temperature changes, changes in humidity, emotional stress, physical activity, smoke~     and/or other scents and gives often rise to nasal symptoms such as rhinorrhea, nasal~     obstruction and/or sneezing.~      nasal hyper reactivity is a clinical feature of rhinitis and rhinosinusitis, affecting more~     than 20% of the total Western population.~      Cold, dry air exposure has been shown to be a reliable method for diagnosis of nasal~     hyperreactivity. The new, shorter protocol for cold dry air provocation that recently has~     been validated as a useful diagnostic tool to evaluate nasal hyperreactivity with high~     specificity and sensitivity, is already a major step forward but still rather time-consuming~     and not always very practical in use.~      A hyperosmolar saline solution loaded on a small nasal sponge as described earlier has also~     been reported as being an effective means of evaluation of nasal hyperreactivity. In~     addition, capsaicin nasal spray has also been reported as being an elegant tool for the~     evaluation of the response of TRP channels on the nasal mucosa.~      So far, we lack data on the comparison between the 3 different diagnostic tools for the~     evaluation of nasal hyperreactivity in rhinitis.~   "
55199|NCT02334592|"~     Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for~     sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV~     radiation. Overexposure is defined as exposure that exceeds the amount needed for vitamin D~     production and could lead to skin or eye damage. Acute overexposure induces sunburn.~     However, the effect of the recommended time exposure schedule on serum 25(OH)D response has~     not been characterized. Further, it is unknown if the maximum time exposures are required to~     reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to~     characterize serum 25(OH)D response to regular sunbed use following the time exposure~     schedule recommended by Health Canada.~   "
55200|NCT02334579|"~     The purpose of this study is to find out the effects (good and bad) of highly focused~     radiation on you and your prostate cancer. The purpose of this evaluation is to see if this~     treatment causes fewer side effects that other standard treatment approaches, and to~     evaluate the effect of this treatment on your prostate tumor and your quality of life over~     time.~   "
55201|NCT02334566|"~     Immigrant and refugee children and youth are the fastest growing segment of Canadian~     society, but their mental health is too often overlooked even though their high rates of~     symptoms are increasingly of concern. These children and youth face the same developmental~     challenges as other children, but migration and resettlement amplify challenges and also~     create additional risks. Although a literature about the effects of immigrant family life on~     the mental health of children exists, very little research has examined the specific extent~     and implications of post-traumatic stress disorder (PTSD) among refugee children and youth.~     In addition, the best practice intervention strategies that most optimally support their~     mental health difficulties have not been evaluated. This study investigates the~     effectiveness of a treatment intervention in a sample of refugee children: Narrative~     Exposure Therapy or NET and KIDNET (developed for younger children), selected due to their~     documented superiority relative to other forms of treatment for children and youth with~     PTSD.~   "
55202|NCT02334553|"~     Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild~     atopic asthma.~   "
55203|NCT02334540|"~     The satiety effects of pulses compared to a matched smoothie will be measured.~   "
55204|NCT02334527|"~     This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with~     metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A)~     (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of~     first-line chemotherapy.~   "
55205|NCT02334514|"~     The purpose of this study is to determine the duration of viral shedding in hospitalized~     patients with influenza virus, treated with oseltamivir.~   "
55206|NCT02334501|"~     This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed~     conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and~     pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.~   "
55207|NCT02334488|"~     Prospective, multicenter, randomized and open label study evaluating the benefit on renal~     function at 12 months post-transplantation, with an immunosuppression without calcineurin~     inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an~     immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.~   "
55208|NCT02334475|"~     Chronic low back pain, with or without lower extremity pain, which arises from various~     structures of the spine constitutes a majority of pain complaints. The sacroiliac joint~     (SIJ) has been implicated as the primary source of pain in 10% to 27% of patients with~     mechanical low back pain below L5 vertebra. The common causes of SIJ pain include a trauma~     like direct fall on the buttocks, a rear-end or broad-side type motor vehicle accident, and~     an unanticipated step into a hole or from a miscalculated height, fusion surgery, anterior~     dislocation, inflammatory and degenerative sacroiliac joint disease and idiopathic. The~     treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic~     therapies including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic agents,~     intra-articular and peri articular injections of SIJ, radiofrequency neurotomy and surgical~     fusion are often performed for pain relief. However, the success of these interventions has~     been determined according to the therapeutic efficacy and correct placement of the drug. The~     image guidance of SIJ injections seems to be important due to the complex anatomy of the~     joint causing a low accuracy when performed according to clinical judgement only. The~     feasibility of ultrasound (USG) guided injection of SIJ has recently been demonstrated~     resulting in very high success rates up to 90%. Various agents being used in SIJ injections~     include local anaesthetics, corticosteroid, botulinum toxin-A, 12.5% dextrose,~     phenol-glycerine-glucose (P2G) and sodium morrhuate (cod liver oil extract). SIJ steroid~     injection is commonly used technique and has been found to be effective to treat SIJ pain.~     However, the main drawback is short term effect. Borowsky et al reported improvement in~     visual analog score (VAS) of 14.1% and reduction of VAS ≥ 50% in only 12.50% patients at 3~     months after intra-articular steroid (2 mL 0.5% bupivacaine plus 40 mg methylprednisolone)~     SIJ injection. Treatment modalities being currently used do not, in general, address the~     disease process itself, there is clearly a need to investigate treatments that are more~     widely applicable for symptom management and which may also directly address the disease~     process itself. Current research efforts aim at modifying the rate of healing of joint by~     using biological healing factors which are various growth factors (transforming growth~     factor, vascular endothelial growth factor, fibroblast growth factor, epidermal growth~     factor, platelet derived growth factor etc.) found abundantly in the human blood especially~     in platelets. The platelet rich plasma (PRP) is an ideal autologous biological blood-derived~     product, which can be exogenously applied to various tissues where it releases high~     concentrations of platelet derived growth factors that enhance the body's natural healing~     response. In addition PRP possesses antimicrobial properties that may contribute to the~     prevention of infections. PRP is now being widely tested in different fields of medicine for~     its possibilities in aiding the regeneration of tissue with low healing potential. Local~     injection of PRP is a new modality which has been effectively used for the treatment of~     Achilles tendon injury in athletes, chronic epicondylar tendinopathy, chronic patellar~     tendinosis, rotator cuff tear, anterior cruciate ligament injury, gonoarthrosis and plantar~     fasciitis. The intra-articular injection of PRP into knee joint has been found to reduce the~     incidence of local inflammatory changes in early knee osteoarthritis. Recently, PRP has been~     used for low back pain caused by SIJ laxity showing significant improvement in pain scores.~     However, there is no study at present comparing the efficacy of intra-articular injection of~     PRP with corticosteroids for the treatment of chronic SIJ pain. Considering the vast~     potential of PRP and its safety, this study aimed at studying the efficacy of ultrasound~     guided intra-articular SIJ injection of leukocyte free PRP for chronic low back pain due to~     SIJ pathology. In the current study, we tested the hypothesis that the SIJ injection of~     leukocyte-free PRP may be more effective for the treatment of sacroiliac joint pain as~     compared with steroid injection.~   "
55209|NCT02334462|"~     Background:~      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito~     that carries the parasite bites them. Malaria infection does not happen in the United~     States, but many people in Africa, Asia, and South America are at risk for it. Researchers~     want to test two vaccines that may help decrease malaria infection.~      Objective:~      - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in~     humans and cause an immune response that will prevent malaria parasites from correctly~     growing in the mosquito.~      Eligibility:~      - Healthy adults ages 18 50.~      Design:~        -  There are several groups in this study. Each group will receive a different dose of the~          vaccine and some groups will received both vaccines.~        -  Vaccinations will be given on two days about 4 weeks apart.~        -  Participants will receive each vaccine as an injection into the arm. Blood will be~          drawn on the day of vaccination.~        -  In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic~          visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts~          over the next 6 months.~        -  At each visit, participants will be evaluated for side effects to the vaccine and any~          new health changes or problems. They will be asked how they are feeling and if they~          have taken any medicine. Blood and urine samples may be taken at the visit. More~          follow-up visits may be needed to follow up on changes or problems.~   "
55210|NCT02334449|"~     Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single~     and multiple doses of the investigational medicinal product in healthy volunteers~   "
55211|NCT02334436|"~     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum~     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar~     lines associated with corrugator and/or procerus muscle activity in adult subjects~   "
55212|NCT02334423|"~     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum~     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar~     lines associated with corrugator and/or procerus muscle activity in adult subjects~   "
55213|NCT02334410|"~     After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the~     associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive~     bone loss in the long bones of the legs. It has been documented that the most rapid phase of~     bone loss is during the first year, but bone loss can continue for a number of years~     post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous~     longitudinal study, in which we described rates of bone loss in the first year of SCI using~     peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of~     patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral~     density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that,~     by performing repeat bone scans within months of injury, we are able to detect and~     red-flag those patients at highest risk of rapidly weakening bones. We propose that, once~     these patients have been identified, there is an opportunity to intervene with~     bone-stimulating interventions within months of injury, before BMD reaches dangerously low~     values. In this new phase of the research, therefore, we are introducing an intervention~     phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention,~     Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast~     bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells,~     to encourage bone formation. If shown to be successful as an early bone-stimulating~     intervention, it may prove to be a tool for reducing future fracture risk in patients with~     SCI.~   "
56300|NCT02320188|"~     The purpose of the study is to determine in a randomized controlled trial (RCT), the~     efficacy of eccentric exercise training in restoring muscle mass and function in patients~     with rheumatoid cachexia.~   "
55214|NCT02334397|"~     Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to~     maternal exhaustion, which leads to an inability to push effectively; 40% of operative~     vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma~     is increased three to four fold with operative delivery. This randomized, controlled trial~     will compare rates of operative vaginal delivery and severe birth trauma in two groups of~     women: (1) an intervention group who will participate in the antepartum Total Control®~     fitness and education program modified for pregnancy; and (2) a control group. Women will be~     recruited and followed from the second trimester until 6 weeks postpartum; all will complete~     validated questionnaires regarding their (1) level of worry and knowledge about their~     birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4)~     satisfaction with their birthing experience and (5) level of depressive symptoms at various~     time points during and after their pregnancy. Obstetrical data will also be collected.~   "
55215|NCT02334384|"~     The goal of this study is to demonstrate safety and tolerability of a novel antimicrobial~     wound dressing, Antimicrobial TheraGauze. The unique microvillous structure of TheraGauze is~     ideal for the development of an antimicrobial wound dressing. In vitro testing has~     demonstrated that tobramycin is an ideal compound for integration into TheraGauze providing~     excellent killing of MRSA and other organisms that commonly cause wound infections.~     Tobramycin is a non-absorbable aminoglycoside that will be contained solely to the wound bed~     preventing any potential for systemic toxicities. In vivo testing of tobramycin-impregnated~     TheraGauze used in mouse wound models has confirmed no systemic absorption of tobramycin as~     demonstrated by undetectable blood levels. TheraGauze has been commercially available for 10~     years as a wound dressing. Tobramycin has been available for many years as a topical~     antibiotic as eyedrops and as an inhaled antibiotic for patients with cystic fibrosis,~     demonstrating excellent safety in both cases.~      This Phase I trial will test Antimicrobial TheraGauze (ATG) as an antimicrobial wound~     packing for patients presenting to an Emergency Department with skin abscess (furunculosis).~     Subjects will either receive ATG or standard of care wound packing (cotton wick or iodoform~     wick). Subjects will return to the ED in 2 days for wound packing removal and reassessment~     of their wounds and symptomatology. A final followup will be performed by a physician and~     study coordinator in an outpatient setting on day 7.~   "
55216|NCT02334371|"~     The importance of selecting patients with ovarian cancer who will benefit from either~     primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery~     has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter~     remains to be discovered. We believe that combined magnetic resonance imaging and positron~     emission tomography (MR-PET) can be of great clinical value in preoperative staging of~     patients with ovarian cancer.~   "
55217|NCT02334358|"~     To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including~     injection site local reactions and biodegradability~   "
55218|NCT02334345|"~     Radiotherapy may cause severe skin changes that significantly interfere with the patient's~     quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and~     various topical agents are recommended to help patients in the management of radiation skin~     reactions, but evidence to support the value of the topical treatments of the irradiated~     skin is lacking. In the present study we investigated the effects of two topical agents used~     as supportive care to protect skin during radiotherapy.~   "
55219|NCT02334332|"~     This pilot clinical trial studies an educational brochure in preparing patients with gastric~     cancer and their caregivers for recovery after surgery. Giving an educational brochure may~     help prepare patients and their caregivers by improving knowledge about symptoms after~     surgery. It may also improve quality of life and reduce worry after surgery.~   "
55220|NCT02334319|"~     This pilot clinical trial studies how well ganetespib works before surgery in treating~     patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed~     by surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Studying samples of blood and tissue in the laboratory from patients~     receiving ganetespib may help doctors learn more about the effects of ganetespib on cells.~     It may also help doctors understand how well patients respond to treatment.~   "
55221|NCT02334306|"~     A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary~     Sjögren's Syndrome~   "
55222|NCT02334293|"~     The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty~     acids, Omegaven, would be beneficial in the management of steatotic liver injury in~     parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of~     arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid~     deficiency through the presence of small amounts of arachidonic acid, and improved clearance~     of lipids from the serum.~   "
55223|NCT02334280|"~     The goal of this project, which has not changed, is to evaluate the statewide implementation~     of a two-component intervention (health promotion plus academic detailing) with respect to~     consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is~     delivered to people with serious mental illness (SMI) by two community mental health clinics~     (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with~     SMI. The specific aims of this study are:~        1. Evaluate person-level and provider-level outcomes including: (a) consumer health~          behaviors, health indicators, mental health indicators, and acute health service~          utilization, (b) provider prescribing practices and program fidelity, and (c) program~          costs.~        2. Evaluate system-level outcomes including: (a) consumer health behaviors and health~          indicators, (b) provider prescribing and program fidelity, and (c) acute services use.~   "
55224|NCT02334267|"~     This is a physiology study of two commercially available dialysate acid concentrates. It is~     a prospective, single center single blind, cross-over, two week investigation of~     intradialytic acid-base kinetics and physiology using two commercially available acetate~     hemodialysate compositions in prevalent hemodialysis patients.~   "
55225|NCT02334254|"~     To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple~     antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients~     with atrial fibrillation and coronary artery disease undergoing percutaneous coronary~     intervention (PCI).~   "
56312|NCT02320032|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various~     doses and dosing intervals of aripiprazole lauroxil.~   "
55227|NCT02334228|"~     Few studies targeting obesity in serious mental illness have reported clinically significant~     risk reduction, and non have been replicated in community settings or demonstrated sustained~     outcomes after intervention withdrawal. The researchers sought to replicate positive health~     outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program~     across urban community mental health organizations serving an ethnically diverse population.~   "
55228|NCT02334215|"~     The purpose of this study is to determine which of three approaches started in jail is more~     effective in treating opioid use disorder: (1) methadone treatment without counseling~     (termed interim methadone) coupled with case management (termed patient navigation); (2)~     interim methadone without patient navigation; (3) or an enhanced treatment as usual~     including opioid detoxification, overdose prevention and drug treatment information and~     referral.~   "
55229|NCT02334202|"~     This research study is aimed at the prevention of excessive weight gain in female military~     dependents at high risk for adult obesity. The purpose of this study is to determine whether~     reducing Loss of Control (LOC) eating and associated indicators through use of interpersonal~     psychotherapy (IPT) will be feasible and acceptable to female adolescent dependents who~     report such behaviors. Moreover, patterns in the data will be examined to assess whether IPT~     influences body weight gain trajectories and prevent worsening disordered eating and~     metabolic functioning among female military dependents at heightened risk for unhealthy~     weight gain.~   "
55230|NCT02334189|"~     The study aims to test whether it is possible to reduce pressure on Emergency Departments by~     sending a personal feedback letter to people who have recently attended an Emergency~     Department and whose health issues could likely have been dealt with elsewhere. These~     attendances clearly have many causes. However, it is likely that some attendances are due to~     behavioural factors - in other words, the various ways in which users interact with~     services. This study focuses on one particular behavioural factor: lack of feedback to users~     making avoidable visits.~      The study will take place in collaboration with an NHS hospital trust. Each week during the~     trial, the hospital trust will identify those Emergency Department attendances in the last~     seven days which, according to clinical judgement, could have been dealt with elsewhere.~     Patients will then be randomly selected to receive a letter containing information on~     alternative healthcare options for non-emergency health concerns. Patient records will be~     analysed to determine whether the patients who received the letter are less likely to make~     an avoidable repeat visit to the Emergency Department in the future, compared with patients~     who received no letter.~   "
55231|NCT02334176|"~     The investigators conducted this prospective, randomized, observer-blinded, non-inferiority~     trial to compare single perivascular injection to double injection (musculocutaneous nerve~     and perivascular injection) US guided axillary brachial plexus block.~   "
55232|NCT02334163|"~     Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in~     patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of~     administering nitazoxanide on the improvement of patient's quality of life.~   "
55233|NCT02334150|"~     Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but~     whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized~     controlled trial examined whether CSEA affects the electrophysiological index of postpartum~     pelvic floor muscle during labor. The investigators plan to recruit 300 primiparous healthy~     women.~   "
55234|NCT02334137|"~     The overarching purpose of this project is to provide diabetes education to the diverse~     patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at~     California Pacific Medical Center. Because of high clinic volume in a teaching environment,~     our patients often experience long wait times. The goal of this program is to utilize this~     wait time for diabetes education, a much-needed corollary to the eye care that patients~     receive at our clinic.~      This pilot project will investigate the impact of a program like this in our patient~     population. Specifically, the investigators are investigating whether diabetes education~     delivered in an ophthalmology setting enhances patient understanding of diabetes (via~     knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This~     is a 6-month study that runs through April 2015, and looks at the impact of an interactive~     diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of~     patients who meet with a diabetes educator will also be shown their own retinal images~     (compared to a normal retina).~   "
55235|NCT02334124|"~     Many children every year present to the Emergency Department (ED) at The Royal Children's~     Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home~     with oral antibiotic treatment. If it is complicated and severe, these children are admitted~     to hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle~     group with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are~     not acutely unwell. In order to determine whether it is just as effective for children with~     uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via~     Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need~     to conduct a larger study and randomly assign children to receive either HITH or hospital~     ward care.~      The study aims to compare 1) the rate of treatment failure of home treatment with IV~     ceftriaxone versus hospital treatment with IV flucloxacillin; 2) the safety of treatment at~     home versus treatment in hospital; and 3) the effect of exposure to short course ceftriaxone~     versus flucloxacillin on nasal and gut micro-organism resistance patterns and the clinical~     implications of this. The main outcome is treatment failure defined as a change in treatment~     due to lack of clinical improvement or adverse events.~   "
55270|NCT02333669|"~     Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption~     through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing~     evidence has demonstrated that these lung disorders might be an important cause of neonatal~     respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function,~     particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might~     predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of~     SCNN1A are associated with NRDS, we conducted a case-control study to investigate the~     NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A~     gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).~   "
55236|NCT02334111|"~     The impact of parental opioid use disorder and other substance use exposure on child welfare~     and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering~     mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94%~     of children exposed to opioids in utero will be diagnosed with neonatal abstinence syndrome~     (NAS), a set of behavioral and physiological complications resulting from abrupt substance~     withdrawal at birth. Opioid abuse is usually coupled with use of other substances, and~     research has demonstrated that children born to parents with substance use disorders are~     three to four times more likely to suffer abuse or neglect.~      Currently, the standard of care for pregnant women who are being treated for opiate~     dependence at Boston Medical Center (BMC) is to receive all their prenatal care in the~     RESPECT Clinic, an innovative program of the BMC Department of Obstetrics and Gynecology~     designed to treat addiction during the prenatal and early postnatal period. Once the child~     is born, BMC staff files a report of suspected child abuse and neglect in accordance with~     the Massachusetts General Laws section 51A. The state Department of Children and Families~     makes a determination regarding the disposition of these families. Medically, most of these~     children are treated in-patient at BMC for NAS and then discharged to follow-up with routine~     pediatric primary care. Currently, approximately 85% of infants born exposed to opioids go~     home with their mothers, and the remainder receive substitute care, either with other family~     members or via foster care.~      This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of~     promising and evidence-based practices designed to strengthen family protective factors and~     improve health permanency and well-being outcomes for children born to mothers in treatment~     for opioid use disorder. Anticipated outcomes of the intervention include fewer reports of~     supported child abuse or neglect filings in the child's first year of life, fewer days in~     out-of-home placement; fewer terminations of parental rights in the child's first year of~     life; and improvements in family functions overall (e.g. improved access to basic~     needs/social determinants of health, improved parental resilience, and decreased maternal~     depression).~   "
55237|NCT02334098|"~     The objectives of this project are as follows:~        1. To assess whether omega-3 dietary supplementation for six months can reduce~          externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren~          aged 8 to 18, both at the end of treatment and six months post-treatment~        2. To assess whether omega-3 supplementation can enhance cognitive and brain functioning~          as measured both by neurocognitive and psychophysiological measures~        3. To assess whether any improvements in cognitive and brain functioning can help account~          for any improvements in behavior.~   "
55238|NCT02334085|"~     The HOW Study is a first-of-its-kind international online study for women and men with and~     without a history of breast cancer. The investigators will collect information about your~     health, your job, your diet, and your family history, among other topics that can help us~     get a better understanding of breast cancer and its potential causes. Periodically, the~     investigators will send you questionnaires about anything and everything. All you have to do~     is fill them out online. It's that simple. This is a partnership and the investigators need~     you for the long haul. The more questionnaires you fill out, the more information the~     investigators will have that can help us have a better understanding of why women get breast~     cancer.~   "
55239|NCT02334072|"~     Even though the effects of anesthetic agents both inhalation and intravenous have been well~     described, the effect of laryngeal mask airways haven't. The purpose of the study is to~     determine the effects of different types of laryngeal mask airways on middle ear pressure.~   "
55240|NCT02334059|"~     Opioid sparing anesthesia is extremely important in the post-operative obese population.~     With more and more obese patients entering the operating room a multi-modal approach to~     analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of~     this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is~     very sparse.~   "
55241|NCT02334046|"~     Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually~     need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was~     to investigate the optimal effect-site concentration of remifentanil for preventing cough~     during emergence in elderly patients under sevoflurane and remifentanil anesthesia.~   "
55242|NCT02334033|"~     Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and~     kidney functions are known to be closely related. Increased serum level of Cystatin C, a~     sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The~     investigators aimed to evaluate the predictive value of serum Cystatin C for control of~     hypertension in a community-based study.~   "
55243|NCT02334020|"~     The purpose of the study is evaluate the effect of the Mental Health First-aid training~     course on a Danish population of employees.~   "
55244|NCT02334007|"~     After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein~     Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs.~     These clots are usually prevented by the administration of low-molecular-weight heparin, a~     blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular~     surgery, this treatment is used until patients are discharged from the hospital. However, in~     orthopaedic surgery, there is strong evidence that longer term preventative treatment up to~     35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there~     is an even greater risk of developing PE because of the surgical stress, the common presence~     of cancer and direct damage to blood vessels in the lung during surgery. Despite the~     potential utility, the use of extended VTE prevention has never been evaluated in the~     thoracic surgery population. If extended treatment prevents clots, more patients will avoid~     complications related to VTE. There is currently very limited information available on the~     incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and~     the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in~     contrast to patients undergoing orthopaedic surgery where ET has become standard of care,~     duration of thromboprophylaxis is not well defined in this patient population. Therefore,~     there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on~     the incidence of VTE in the post-op population.~   "
55245|NCT02333994|"~     The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in~     Reducing Fear of Falls in Elderly Population . In the present study the educational program~     along with balance training was delivered to group A, (Experimental group) and only Balance~     training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once~     weekly. Education program included education about the risk factors of falls such as~     environmental hazards, importance of good nutrition, use of stick while walking, avoiding~     slippery surfaces. Balance training consists of stance activities and balance exercise~     program. The outcome measures for this intervention were Activities specific balance~     confidence scale and berg balance scale.~   "
56336|NCT02319720|"~     Management of chronic wounds with:~        1. Bone Marrow Aspirate Plus Cultured Cells Group~        2. Cultured Cells Alone Group~        3. Bone Marrow Aspirate Alone Group~        4. Control Group~   "
55246|NCT02333981|"~     This study was formulated to determine the efficacy of passive oral motor regimen for~     drooling in children with multiple disabilities. Seven subjects aged 7-19yrs were taken in~     the study. All the subjects received passive treatment which included light touch, stroking,~     vibration, tapping, pressure and stretch. All the techniques have been proved to be~     effective in treating drooling. Relative sterility and hygiene was maintained throughout the~     procedure as sterilized gloves and napkins were used. The measurement protocol was designed~     to check effectiveness on drooling in children. The protocol was given for 4 weeks with~     treatment sessions given 3 times per week and the treatment duration was 30min. Twelve~     sessions of oral motor stimulation therapy given during the 4 weeks. Thirteen after 4 weeks~     of treatment, improvement was found in terms of the severity as well. Primary outcome~     measure taken was Drooling Frequency and Severity rating scale and secondary outcome measure~     being taken was drool quotient. Pre and post intervention scores of Drooling Frequency and~     Severity rating scale and drool quotient were taken and data was analyzed using wilcoxon~     signed rank test .~   "
55247|NCT02333968|"~     Pain is a prevalent and distressing symptom in patients with cancer, having an enormous~     impact on functioning and quality of life. Integration of patient self-management and~     professional care by means of care technology provides new opportunities in the outpatient~     setting. In this project a technology based and nurse delivered multicomponent~     self-management support intervention has been developed. Important components include~     monitoring, feedback, education, and nurse support. Following feasibility evaluation, the~     primary aim of this randomized controlled trial is to assess the effect of the intervention~     regarding pain intensity and quality of life as compared to care as usual. Secondary~     outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and~     pain medication use. Besides, a cost-evaluation and summative process evaluation will be~     performed.~   "
55248|NCT02333955|"~     The primary objective of this study is to determine the safety and tolerability of extended~     dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease~     (CKD).~   "
55249|NCT02333942|"~     This study is being performed to generate data regarding brain vibration /oscillation~     differences between individuals with dementia and normal controls. The purpose of this study~     is to compare signal patterns generated from the impact on the scalp from these brain~     oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar~     Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.~   "
55250|NCT02333929|"~     The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban~     Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to~     determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa~     activity.~   "
55251|NCT02333916|"~     Rationale: Body weight is not well regulated in all individuals. In an obesogenic~     environment, where overeating is common, some individuals are more prone to weight gain and~     therefore overweight than others. Yet, the reasons behind this are unclear. Resistant~     individuals often have higher physical activity levels (PALs). It seems that - at higher~     levels of physical activity and therefore energy expenditure - satiety signals are more~     precisely regulated, making one better at matching energy intake with expenditure. In other~     words, active people may not overeat where sedentary people would. However, this does not~     explain the differences in weight gain observed when subjects all have to overeat (imposed~     overfeeding). It could be that active people are better able to cope metabolically with the~     extra calories because of already higher levels of carbohydrate and fat oxidation compared~     to their inactive counterparts.~      Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate~     balance and oxidation and more specifically fat balance and oxidation; 2/ to study the~     effects of exercise and training on fat oxidation during overfeeding (normal diet~     composition).~      Study design: This controlled intervention study will follow a cross-over design. Each~     subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated~     by a 10-week training period.~   "
55252|NCT02333903|"~     This study compares the ratio of lean mass losses over total body mass losses between~     patients undergoing sleeve gastrectomy followed by physical activity training versus~     patients undergoing sleeve gastrectomy only~   "
55253|NCT02333890|"~     Chloroquine (CQ) is a well known, well tolerated medication that has been used for many~     years traditionally for arthritis, lupus, and malaria. It has anti-inflammatory properties~     but is often the drug of choice for arthritis and malaria due to its few side effects.~     Recently, laboratory investigations have proven that CQ may potentially have anti-cancer~     properties, by inhibiting a process which allows cancers such as breast cancer to continue~     to grow (a process known as autophagy). Therefore, this study will look at how well CQ can~     inhibit the growth of breast cancers in patients while waiting for surgery.~   "
55254|NCT02333877|"~     The purpose of this study is to determine whether suture using the Device of Leukosan~     Skinlink is more faster and safer than that of nylon in the treatment of simple wound for~     ED patients.~   "
55255|NCT02333864|"~     The purpose of this study is to determine if the POGO® system delivers accurate blood~     glucose readings in the hands of the lay user and assess the POGO® system accuracy when used~     by trained health care professionals.~   "
55256|NCT02333851|"~     Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70%~     intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine~     once daily and glulisine before meals) hospitalized patients with type 2 diabetes.~   "
55271|NCT02333656|"~     Previous research has shown that the osteoarthritis care for persons with hip or knee~     osteoarthritis in Norway has a potential for improvement as the provided care may not~     necessarily reflect evidence-based guideline recommendations. This study will determine if a~     new model for integrated osteoarthritis (OA) care in primary health care will result in~     improved quality of osteoarthritis care and health benefits for the patients (reduced pain~     and body weight, increased function and activity level) among patients with hip and/or knee~     osteoarthritis. Further, this study will examine if the new model reduce the number of~     unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in~     secondary care, and if it increases the number of referrals to physiotherapy treatment and~     the number of discharge reports from the physiotherapists to the referring general~     practitioner.~   "
56337|NCT02319707|"~     To compare the efficacy of three different protocols of third stage management in preventing~     PPH.~   "
55257|NCT02333838|"~     Allogeneic cord blood stem cell transplantation is a potentially curative therapy for~     patients with haematological malignancies. We have extensive experience with the use of Cord~     Blood Transplantation (CBT) in patients with advanced myeloid malignancies. In adults~     however, the 40% Non-Relapse Mortality (NRM) rate observed after CBT conditioned with a~     myeloablative conditioning has encouraged the development of CBT with Reduced Intensity~     Conditioning (RIC). Our previous national CBT protocol (the Minicord French protocol -~     NCT00797758) showed that RIC CBT can reduce NRM, but relapse remains the main~     post-transplant event (>30% at one year). Thus, the development of reduced toxicity rather~     than RIC conditioning for CBT is warranted in order to improve the outcome of such~     transplants by limiting NRM and reducing relapse rate. The Fludarabine, ATG and intensified~     doses of IV Busulfan (9.6 mg/Kg total dose) regimen is a well-established preparative~     regimen for reduced-intensity/toxicity conditioning prior to allogeneic stem cell~     transplantation using peripheral blood stem cells mobilized with G-CSF (ClinicalTrials.gov~     Identifier: NCT00841724). However, such regimen is likely not sufficient to allow for CB~     cell engraftment. Thiotepa is an alkylating and radio-mimetic agent with a large anti-tumor~     activity including leukemic cells, the ability to cross the blood-brain barrier and to~     improve engraftment of hematopoietic stem cells. This drug has been combined to usual~     conditioning regimen without increasing the toxicity but improving the engraftment rate and~     potentially reducing the relapse rate. Thus, in the context of adult CBT for high risk~     myeloid malignancies, we propose to prospectively evaluate a reduced toxicity conditioning~     based on the association of Thiotepa, Fludarabine, IV Busulfan and ATG with the objective to~     achieve acceptable NRM rates, and to allow for improved anti-leukemic control based on the~     cytotoxic component of the conditioning regimen itself, while waiting for the long term~     immune-mediated disease control (GVL effect).~   "
55258|NCT02333825|"~     This is a multi-center, randomized controlled clinical trial, the purpose of which is to~     determine if patients age 25 and younger who undergo medial patellofemoral ligament (MPFL)~     reconstruction have lower rates of recurrent instability compared to those treated~     non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its~     proper position in the groove on the femur (thighbone). Instability refers to a situation in~     which the kneecap moves out of place, or dislocates. When instability is recurrent, it~     occurs more than once in the same knee.~   "
55259|NCT02333812|"~     Head and neck cancers usually occur in patients who have a history of long tobacco use.~     Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways~     and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck~     cancer share a common environmental risk factor in cigarette smoke exposure. the~     investigators hypothesize that patients with chronic lung disease related to smoking have a~     higher risk to develop cancer in the head and neck.~      The investigators designed a study to assess the prevalence of cancer and pre-cancer disease~     in the head & neck in patients with chronic lung disease. the investigators will examine~     patients with and without a history of smoking and chronic lung disease in order to~     determine the prevalence of head and neck cancer in the different groups. The patients who~     will be included in the study will undergo comprehensive evaluation of their lung function~     and voice performance.~      This study is a joint effort of the Pulmonology Institute and the Department of~     Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.~   "
55260|NCT02333799|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability and~     pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment~     (option for 9 months for subjects who remain culture positive at month 4) in Subjects with~     either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or~     non-responsive multi-drug resistant tuberculosis (MDR-TB).~   "
55261|NCT02333786|"~     Investigators designed a prospective randomized controlled study to compare the~     long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial~     catheterization in pediatric patients younger than 5 years old.~   "
55262|NCT02333773|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Portal venous tumor emboli.~   "
55263|NCT02333760|"~     An open follow up study of patients enrolled in the Phase 1/2 clinical trial of~     haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with~     autologous CD34+ cells transduced with the w1.6_hWASP_WPRE (VSVg) lentiviral vector.~   "
55264|NCT02333747|"~     The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery~     in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators~     conducted this prospective, randomized, double-blind study to verify the hypothesis that~     pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.~   "
55265|NCT02333734|"~     The overall objective of this study is to examine the blood flow in the thigh muscles and~     sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a~     bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following~     parameters are included in the assessment:~        -  Sugar Metabolism~        -  Muscle and fat mass~        -  The blood flow at rest around the thigh muscles~        -  Oxygen uptake test on a bicycle ergometer and 5 km time trial~   "
55266|NCT02333721|"~     The purpose of this study is to explore the short-term, long-term and oncological outcomes~     of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for~     advanced middle or upper third gastric cancer.~   "
55267|NCT02333708|"~     To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in~     larger amounts in the blood of patients with histologically proven giant cell arteritis~     (GCA), compared with patients matched for age, sex and with or without inflammatory~     syndrome.~   "
55268|NCT02333695|"~     A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The~     apparatus comprises a combination of several magnets enclosed in a supportive cover. The~     magnets are placed in a proper position and their polarity can be changed at any time~     without any difficulty.~   "
55269|NCT02333682|"~     The investigators are intending to perform a clinical study in healthy subjects on the~     pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3~     (cholecalciferol) in order to gain insight into the dose response relationship and to assess~     kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will~     be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin~     D3 will be measured throughout the study to assess compliance with the restriction of~     exogenous vitamin D supplementation.~   "
55272|NCT02333643|"~     A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety~     and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with~     cutaneous warts.~   "
55666|NCT02328508|"~     This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing,~     inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial~     wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with~     diabetes.~   "
55273|NCT02333630|"~     The investigators aim to study the clinical efficacy of a mobile health application,~     AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel~     application developed by members of the study team that was previously studied in a pilot~     study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was~     universal usage and acceptance by all participants of this novel form of technology and~     asthma management. This current study aims to measure clinical outcomes for users of the~     app.~   "
55274|NCT02333617|"~     This is a blinded randomized controlled trial to assess the effectiveness of manual therapy~     to improve hip abduction strength in patients with acute anterior knee pain.~      The primary objective of this study is to see if manual therapy to the gluteus medius can~     significantly alter within-session measurements of hip abductor strength in patients with~     anterior knee pain.~      The secondary objective of this study is to see if manual therapy to the gluteus medius can~     significantly alter within session pain in patients with anterior knee pain.~   "
55275|NCT02333604|"~     The Cancer Support Community's (CSC) Research and Training Institute has created the Cancer~     Experience Registry: An Online Initiative to Change the Future of Cancer Care to identify~     and understand the emotional and social needs of cancer survivors. Armed with this~     knowledge, the investigators will raise awareness about and help develop programs to address~     the needs of cancer survivors. Anyone who has ever received a cancer diagnosis, whether~     recently diagnosed, in treatment, or years post-treatment can participate. Interested cancer~     survivors can register at www.cancerexperienceregistry.org~   "
55276|NCT02333591|"~     GLP-1 is an agent for treatment of type 2 diabetes and may have protective effects on the~     cardiovascular system. The mechanism is complex and there seems to be a dual function with~     intact GLP-1 (7-36), acting through the GLP-1 receptor, and the GLP-1 (9-36) metabolite~     acting independently of the GLP-1 receptor.~      Coronary flow reserve (CFR) is the ratio of flow through the coronary arteries during stress~     to during rest and it reflects coronary microcirculation. Impaired CFR is a strong predictor~     of poor prognosis of cardiovascular disease.~      The aim of the study is to investigate the acute effects of GLP-1 on coronary~     microcirculation and endothelial function in adults with obesity.~   "
55277|NCT02333578|"~     A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease~     (EVD) Convalescent Plasma (ECP) for treatment of EVD.~   "
55278|NCT02333565|"~     To determine if combination of everolimus and octreotide exert an anti-tumoral activity in~     recurrent and/or aggressive meningiomas growth with limited adverse effects.~   "
55279|NCT02333552|"~     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous~     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in~     Indonesian elderly.~      This study was aimed to define the risk factors of frailty transitional status and its~     correlation with quality of life in Indonesian elderly outpatients.~   "
55280|NCT02333539|"~     Pump It Up! is a 4-year longitudinal study that provides intervention to adolescents (ages~     10-18 years) with type 1 diabetes who use an insulin pump.~   "
55281|NCT02333526|"~     The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from~     venous blood of patients with infectious intestinal diseases such as Clostridium~     difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or~     ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients~     with active inflammation and with disease in remission. Secondary objectives were the~     assessment of correlation of the above-mentioned factors with the CRP value. Subjects will~     be volunteers. Blood will be taken as part of the routine clinical work-up after the written~     agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay.~     In addition, the subjects are asked to answer a short questionnaire. The study is designed~     as a prospective, comparative cohort study.~   "
55282|NCT02333513|"~     This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in~     patients with recurrent high-grade glioma with IDH1/2 mutation.~   "
55283|NCT02333500|"~     This prospective pilot study will compare adolescents with restrictive anorexia nervosa who~     participated for 3 months at olfactory workshops, patients who did not, and healthy~     patients.The groups will be evaluated before the workshops and after three months, with the~     wanting score after olfactory stimuli and with serum oxytocin level.~   "
55284|NCT02333487|"~     The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral~     dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.~   "
55285|NCT02333474|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
55286|NCT02333461|"~     Excess caloric consumption, particularly from inexpensive, energy dense foods that are high~     in fat and refined carbohydrates, is a major driver of the global obesity epidemic. Dietary~     supplements that promote reduced intake of energy dense foods and/or impact the absorption~     and metabolism of fat and carbohydrates in the body can be used to help consumers control~     their weight. We identified two separate mechanistic approaches to target these effects.~      Diacylglycerol acyltransferase-1 (DGAT-1) is an enzyme involved in the formation of dietary~     fat into circulating triglycerides within the body. Once dietary fat is digested and~     absorbed, the resulting fatty acids are re-esterified into triglycerides. Inhibition of~     DGAT-1 results in delayed and decreased re-esterification of dietary fats into circulating~     triglycerides. It is hypothesized that this effect may lead to decreased deposition of~     excess dietary fat as adipose tissue, possibly due to increased fatty acid oxidation in the~     enterocytes.~      Ghrelin is a hormone that is known to stimulate appetite in humans. When calorie dense fatty~     foods are sensed in the stomach, ghrelin is acylated and activated via ghrelin~     O-acyltransferase (GOAT). The activation step attaches a medium chain fatty acid to the~     ghrelin molecule that enables it to transmit a signal in the brain that triggers eating and~     fat storage in adipose tissue. Interfering with the GOAT pathway will inhibit ghrelin~     activation and possibly diminish food intake and lipid storage. This concept is supported by~     animal studies in which weight gain in a high fat diet model is prevented when GOAT is~     inhibited.~      Our objective was to determine whether botanicals demonstrating in vitro DGAT-1 and GOAT~     inhibition have similar mechanistic effects in the human body. Based on the results of this~     study, prototype formulas may be developed and clinically- tested for outcomes related to~     weight management.~   "
55430|NCT02331589|"~     Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity,~     and cancer related anti-fatigue.~      Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to~     receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines,~     adiponectin, fatigue severity scale, and antioxidant activity were check and compared.~   "
55287|NCT02333448|"~     The study consists in taking 4 tubes of blood at different times over a period of 10 days,~     via a catheter (central venous or arterial catheter) already in place in the usual~     therapeutic management. These samples will make it possible to measure blood levels of~     certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load~     precisely, that is to say the quantity of yeast present in the blood and to monitor this~     quantity over time.~      These samples will be transferred to a specialized unit and stored for a maximum of three~     years for use at the end of the study.~   "
55288|NCT02333435|"~     Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated~     with a major individual and societal burden. Although still controversial, the literature~     suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against~     prostate cancer. One of the proposed mechanisms of action of ω3 lies in their~     anti-inflammatory properties. In addition, there are some observational evidences suggesting~     an association of ω3 intake with a lower rate of depression in cancer patients. However, no~     clinical study has tested the efficacy of ω3 supplementation on psychological and quality of~     life outcomes in that population. Several evidences point to a possible involvement of~     inflammation in psychological issues. Reducing the systemic inflammatory state may have~     beneficial impact on the quality of life of these patients. Preliminary work from this team~     of investigators, in a cohort of patients managed with active surveillance for their~     low-grade prostate cancer, show a strong inverse association between the risk of prostate~     cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a~     type of ω3).~      HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on~     prostate cancer cell proliferation, inflammation and on the patient's psychosocial~     functioning and quality of life.~      The investigators propose a double blind, randomized controlled clinical trial. 130~     consecutive patients suffering from high-risk prostate cancer who choose to be treated by~     radical prostatectomy will be eligible to this study. The presence of high-grade cancer will~     be mandatory.~      The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich~     in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks~     before the prostatectomy and will continue for one year after surgery. The potential~     confounding variables will be measured before the start of the intervention: age,~     anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score),~     pre-operative level of prostate specific antigen and diet.~      This project proposes a simple intervention by dietary supplementation that could eventually~     help to reduce the incidence and/or progression of prostate cancer, and the consequences of~     its treatment, and thus could contribute to diminish the heavy individual and societal~     burden of prostate cancer. The clinical data generated by this trial will serve as solid~     basis for a large-scale phase III clinical trial.~   "
55289|NCT02333422|"~     The investigators therefore propose a pilot study to establish the effectiveness of NIRS~     Neurofeedback training in reducing the intensity of ADHD symptom expression on children,~     improvement of the cognitive and global functions associated with ADHD, effects on cerebral~     blood perfusion in the cortex and safety plus possible unknown side-effects.~   "
55290|NCT02333409|"~     Pancreatic cancer is the sixth most common cause of cancer death in Hong Kong. Patients~     suffering from pancreatic cancer are associated with a poor prognosis and survival of less~     than one year is expected in inoperable tumours (1). Management of these patients would be~     towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this~     intractable pain is often difficult to treat (2). Pain management is a major part of the~     comprehensive therapy in patients with pancreatic cancer, and it also affects their quality~     of life. Electroacupuncture seems to be a promising way to control the cancer pain and~     reduce the dose and side effects of pain killers including opioid. This study aimed to~     investigate the efficacy and safety of electroacupuncture in reducing pancreatic cancer pain~     in patients suffering from inoperable pancreatic cancer.~   "
55291|NCT02333396|"~     The project seeks to study the use of an navigator-based intervention called PICU~     Supports. The study will test the impact of PICU Supports during and after PICU discharge~     on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression,~     post-traumatic stress, health-related quality of life, and complicated bereavement) and on~     parent and healthcare team member assessments of communication and team collaboration.~   "
55292|NCT02333383|"~     This is a prospective mono-country, multi-center study in Ankylosing Spondylitis (AS)~     subjects treated with Adalimumab. At least 200 subjects will be enrolled at approximately 10~     sites. The baseline assessment should be performed prior to the first dose of Adalimumab.~     Study visit will be conducted at 12, 28, 36 and 52 week after baseline. All subjects will~     have one follow-up approximately 70 days after last dose of Adalimumab.~   "
55293|NCT02333370|"~     The purpose of the Phase Ib is to:~        1. determine the recommended dose of LEE011 in combination with a standard dose of~          letrozole as well as to provide additional safety and anti-tumor activity data in Asian~          non-Japanese patients~        2. determine the recommended dose of LEE011 in combination with a standard dose of~          letrozole as well as to provide additional safety and activity data in Japanese~          patients~        3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the~          dose escalation part in combination with a standard dose of letrozole, fulvestrant or~          tamoxifen plus goserelin in Japanese patients.~   "
55294|NCT02333357|"~     This study is developing and testing a 12-step toolkit with five modules, training~     counselors to use them, and studying their frequency of use, desirability, effectiveness and~     patient outcomes. The toolkit includes counselor written guides, posters, client worksheets,~     engagement activities, and videos designed to be shown during substance abuse treatment~     group sessions to explain and encourage 12-step participation.~   "
55295|NCT02333344|"~     It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic~     fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after~     24-month observation.~   "
55296|NCT02333331|"~     The purpose of this study is to determine the efficacy of repeat dosing with multiple dose~     levels of bimagrumab on patient physical function, skeletal muscle mass and strength in~     older adults with sarcopenia. In addition, this study will generate data on the safety,~     tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.~   "
55297|NCT02333318|"~     The objective of this study is to investigate the safety, tolerability and pharmacokinetics~     (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older~     male volunteers.~   "
55331|NCT02332876|"~     Many cancer survivor experience treatment-related impairments in mental abilities such as~     memory, attention, and concentration (known as cognition). Research indicates that physical~     activity can improve cognition in healthy adults; however, little is known about whether~     physical activity can improve cognition among cancer survivors. This study will test whether~     a physical activity intervention results in improvements in cognition among breast cancer~     survivors, which may lead to interventions to improve cognition.~   "
55431|NCT02331576|"~     The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl~     combined with local anesthetics in the post operative pain control with continuous femoral~     nerve block after total knee arthroplasty.~   "
55298|NCT02333305|"~     We propose a study on Ataxia with oculomotor apraxia type 1 (AOA1) in which Coenzyme Q10~     (CoQ10) deficit has been observed. Main objectives of the study are :~        -  To monitor evolution of albumin in patients affected with AOA1 while supplemented with~          CoQ10 ;~        -  To measure with clinical scales and biological markers efficacy of supplementation on~          disease evolution.~      AOA1 is characterised by Hypoalbuminemia. Disease duration is negatively correlated with~     albumin level. This study aims to understand mechanisms of the disease and our hypothesis is~     that correction or stabilization of albumin level with CoQ10 supplementation could impact~     disease evolution. The study is planned from 1 to 2 years supplementation. The CoQ10 is~     classified as a food supplement and has already been tested in other neurological~     conditions.~   "
55299|NCT02333292|"~     Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients~     who show sustained virologic response (SVR) to treatment including direct-acting antivirals~     (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to~     determine the frequency of adverse events, including those that are severe and/or cause~     treatment interruption, in DAA-based therapy in this setting.~      Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the~     Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology~     (SEIMC).~      Study population: HCV-monoinfected patients that initiate DAA-based treatment outside~     clinical trials.~      Variables: The primary efficacy outcome variable is the proportion of patients who reach~     undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety~     outcome variable is the percentage of subjects who discontinue therapy due to adverse~     events.~      Statistical analysis: A descriptive study will be performed, as well as a double sensibility~     analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment~     approach. Those variables that are associated with SVR12 with a p-value <0.2 will be~     included in a logistic regression analysis in which SVR12 will be the dependent variable.~   "
55300|NCT02333279|"~     The investigators will determine the cancer risk in organ transplant recipients compared to~     the general population with the help of statistical analysis. Secondly the investigators~     will try to characterize the different cancer types.~   "
55301|NCT02333266|"~     The purpose of this study is to determine whether the newly developed biosensor can be used~     to detect and quantify fungal cells in human blood samples.~   "
55302|NCT02333253|"~     40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response~     and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or~     more. All patients were revised for history, examinations and investigations, including age,~     type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.~   "
55303|NCT02333240|"~     New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women,~     raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy~     combined with protein leaking into the urine. After birth, women's BP remains elevated for a~     period of time, but in most cases returns to normal over 2-12 weeks. During this period~     medication needs to be adjusted to achieve the correct control. Research suggests that~     better BP control during this period is associated with improved long-term health outcomes.~     The investigators would like to find out whether home BP monitoring, and self-adjustment of~     medications according to an individualised protocol, could improve BP control and patient~     satisfaction.~      This pilot study has been set up to inform the planning of a large-scale multi-centre~     randomised controlled trial by testing the feasibility of the protocol. The investigators~     want to increase our experience of applying this management approach in this subset of~     patients; to select the most appropriate primary outcome measure and to estimate the effect~     size of this intervention; to assess recruitment potential; and to evaluate feasibility of~     coordinating this trial across several centres. The primary objective of the large-scale~     trial will be to determine whether the self-management approach can improve BP control in~     women with medicated hypertensive disorders of pregnancy in the postnatal period.~      Women recruited to the study will be randomly assigned to one of two groups: self-management~     or usual care. Participants allocated to 'usual care' will have their BP monitored and~     medication adjusted by their general practitioner (GP) and midwife as normal. Participants~     allocated to the 'self-management' group will use a home BP monitor daily following~     discharge from hospital after birth. They will be provided with an individualised schedule~     for gradually decreasing their medication(s) in line with their BP readings. Women will be~     followed up for 6 months.~   "
55304|NCT02333227|"~     The hypothesis of the investigators' project is that comprehensive primary preterm birth~     prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention),~     will reduce the rate of periodontal disease and caries, preterm birth prevalence, and~     neonatal mortality.~   "
55305|NCT02333214|"~     Frailty is a highly prevalent condition, reaching approximately 7% to 30% of older adults~     aged from 65 up to 80 years [2]. Although exercises seemed to be beneficial for the frail~     elders, there is still insufficient evidence to indicate the appropriate modality, frequency~     and intensity of physical exercises that were able to improve physical functioning in this~     population [9]. The virtual reality (VR) using interactive games (exergames) have generated~     broad scientific and clinical interest in recent years[10]. Studies indicate that older~     adults can benefit from training with exergames in improving mobility [12, 13], lower limb~     strength [14], cognition, particularly executive function [13], body balance [10, 15-18],~     reaction time [12] and may contribute indirectly to prevent falls [10, 19, 20]. But, there~     is still insufficient evidence to suggest that the use of exergames are superior even to~     other types of intervention [21-23] or in combination with conventional physiotherapy [24]~     The purpose of this study is to investigate the effectiveness of adding exercises using~     interactive videogames (exergames) in improving physical functioning on frail and pre frail~     older people when compared to conventional physiotherapy. A parallel randomized clinical~     with a 6 month follow-up period will be conducted with 82 frail community dwelling older~     adults. Participants randomized to the Experimental Group will be submitted to 30 minutes of~     conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video~     Game and Entertainment Microsoft System with Kinect sensor.~      The Control Group will receive 50 minutes of conventional physiotherapy. Both groups will~     receive 50 minutes of intervention twice a week for 12 weeks. Primary outcomes will be~     assessed by the Short Physical Performance Battery, the Usual walking speed test and Four~     Step Square Test in the baseline, 3 and 6 months after that.~   "
55306|NCT02333201|"~     Dysphagia significantly contributes to morbidity and mortality in non-critically ill~     patients (as e.g. in stroke). Long term consequences of dysphagia include, among others,~     malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the~     present observational analysis, the investigators aim to elucidate the incidence and the~     impact of dysphagia on the clinical course of a mixed population of ICU patients post~     invasive mechanical ventilation.~   "
55307|NCT02333188|"~     This phase I/II trial studies the side effects of genetic analysis-guided dosing of~     paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium,~     and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer~     that has spread to other parts of the body and usually cannot be cured or controlled with~     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Genetic analysis may help doctors~     determine what dose of irinotecan hydrochloride patients can tolerate.~   "
55308|NCT02333175|"~     The aim of this project is to evaluate the needs and provision of care for patients in the~     late stages of Parkinsonism and their carers in several European countries, to compare the~     effectiveness of different health and social care systems, and to lay the foundation for~     improved outcomes in this population. The investigators will undertake an in-depth~     assessment of patients and their care arrangements in a population recruited through~     networks in six European countries. The systems and procedures that are used in the~     provision of care will be reviewed through a systematic literature review, interviews and~     assessments of patients, carers and health care providers, and through a trial comparing~     assessment by a specialist with management suggestions, guidance and access to telephone~     advice to that of usual care. Through interviews, questionnaire assessment and review of~     current health-care and social care arrangement, the investigators will assess the needs,~     provision of care and use of health-care resources, and their impact on patient and carer~     outcomes in different countries. National and regional databases will also be interrogated~     to identify current practice and use of healthcare resources and drug usage. A systematic~     literature review of the evidence for effective management strategies, analysis of the study~     data, and evaluation of change in outcomes following specialist review will provide the~     basis for recommendations in the management of late stage Parkinsonism. The investigators~     will also evaluate potentially useful outcome measures for use in this patient group. In~     addition to charting the needs and current care provision for late stage Parkinsonism in~     different European countries, its cost and effectiveness, and an analysis of health-care and~     social care predictors of improved outcome, the project will produce a platform for the~     assessment of patients with late stage Parkinsonism, their current treatment and care~     provision, as well as guidelines on the management of this late disease phase.~   "
55309|NCT02333162|"~     This phase I trial studies the side effects and the best dose of intensity modulated total~     marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in~     treating patients with cancers of the blood (hematologic) that have returned after a period~     of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of~     radiation therapy to the bone marrow that may be less toxic and may also reduce the chances~     of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem~     cell transplant may help stop the growth of cells in the bone marrow, including normal~     blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets.~   "
55310|NCT02333149|"~     This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group~     trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to~     assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial~     insomnia in children with attention-deficit disorder.~   "
55311|NCT02333136|"~     The LighTouch device shines imperceptible red light into the skin and measures the light~     that comes back out using the method of Raman Spectroscopy. Some of this light is color~     shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines~     the signals in this remitted light and calculates hematocrit, glucose, protein and~     potentially other analytes. Thus the LighTouch device produces information without painful~     physical insult to the patient and can trend changes in these blood analytes in order to~     predict the need for intervention.~   "
55312|NCT02333123|"~     This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer~     healing. The study also examines whether patients can be recruited to a larger study.~     Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer~     community clinics or hospital out-patient clinics, or registered with a clinic but are~     receiving care at home will be recruited. All patients will receive standard compression~     bandaging. Half of the participants will be randomised to receive aspirin, while the other~     half will receive a placebo.~   "
55313|NCT02333110|"~     Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General~     Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors,~     radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the~     tumor size, tumor location and tumor pathology. However, for many patients this treatment~     involves considerable toxicity, travel and time spent at the hospital. Spatially~     fractionated radiation (SFR) is an alternative technique that consists in delivering one~     single treatment, given through a grid containing holes. The present study is proposing to~     validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors~     (more than 8 cm) or with tumors known to be resistant to radiation.~   "
55314|NCT02333097|"~     Comparative genomic hybridization (CGH)-based microarrays are now often used during~     pregnancy in case of fetal polymalformation in order to assess significant genomic~     alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case~     of isolated congenital heart defect.~      This is the first prospective study aiming at defining the right chromosomal screening when~     a fetal isolated congenital heart defect is identified by ultrasound.~   "
55315|NCT02333084|"~     This is a randomized, placebo controlled study. The first subject is expected to be enrolled~     in July 2014, and the last subject is expected to complete the study by July 2015. Each~     subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega~     Benefits® combination depending on randomization (1:1:1 at each site) during the course of~     the study. Instructions and frequency of use will be determined by the labelling.~   "
55316|NCT02333071|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an~     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered~     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without~     decreased arousal) in premenopausal females.~   "
55317|NCT02333058|"~     The primary goal of this study is to evaluate an alternative myeloablative, but reduced~     toxicity conditioning regimen in children, to describe the safety and efficacy of~     intravenous (i.v.) Treosulfan administered as part of a standardised Fludarabine-containing~     conditioning and to contribute to the current pharmacokinetic model to be able to finally~     give age (or body surface area) dependent dose recommendations. The treatment regimens given~     in the protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data.~     Considering the vital indication for allogeneic haematopoietic stem cell transplantation of~     the selected patient population, the risk-benefit assessment is therefore reasonably in~     favour of the study conduct.~   "
55318|NCT02333045|"~     This study seeks to understand the immune cells in the cervical fluid of in the blood and~     genital tract of HIV-negative healthy female volunteers and to see if these cells can be~     modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine~     used in the treatment of HIV infection.~   "
55319|NCT02333032|"~     The main objective of this study is to determine if a single session of treadmill training~     with a positive slope improves the kinematic parameters of the hip, knee and ankle on the~     paretic lower limb.~      Secondarily we will quantify the efficiency of a such training on kinetic and functional~     parameters.~   "
55320|NCT02333019|"~     While the U.S. teen birth rate is currently at its lowest level, it remains high in relation~     to other industrialized countries and continues to be a public health concern due to health~     risks for teen mothers and their babies, and associated social and economic costs. Parental~     monitoring, supervision, and open communication about sexual issues have been found to be~     protective factors for adolescent sexual activity and pregnancy. Our theoretically based~     Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is~     designed to build parental communication, knowledge, and attitudes to discuss sensitive~     topics with their child, including sexuality, pregnancy prevention, and preventing sexually~     transmitted illnesses (STIs). This age group of children was selected because parental~     communication about pregnancy and STI prevention will be most effective if initiated prior~     to, rather than after, the age when children commonly become sexually active. The Let's~     Talk about Sex program is grounded in behavior change theory and incorporates the use of~     video for behavioral modeling and emotional support.~   "
55321|NCT02333006|"~     This study is conducted over 18 months. The main objective of this study is to test and~     compare the relevance and reliability of different tools for measuring the anosognosia.~      Secondary objectives are :~        -  identify the relevant test who are able to evaluate more specially the cognitive~          processes involved in anosognosia~        -  explore the links between the anosognosia manifestations and the psychological~          manifestations~   "
55322|NCT02332993|"~     The purpose of this study is to examine the changes that result in the wound healing of a~     type II Diabetic using Negative Pressure Therapy after 12 weeks of daily supplementation of~     ImmunAge (Fermented Papaya Preparation (FPP). ImmunAge (FPP) is a supplement made from~     Carica papaya Linn and is available over the counter. ImmunAge (FPP) is an investigational~     drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA).~     Approximately 30 subjects will participate in this study. 15 subjects will take the~     supplementation and 15 subjects to take no supplementation as the control. The~   "
55323|NCT02332980|"~     This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib~     works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell~     non-Hodgkin lymphomas that have returned after a period of improvement or have not responded~     to treatment. Monoclonal antibodies, such as pembrolizumab, block cancer growth in different~     ways by targeting certain cells and allow the immune system to attack the cancer. Idelalisib~     and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective~     treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell~     non-Hodgkin lymphomas.~   "
55324|NCT02332967|"~     The primary objective of this trial is to demonstrate that infants receiving an infant~     formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the~     first 4 months of life, stools that are softer than those of infants receiving a control~     formula.~   "
55325|NCT02332954|"~     The purpose of the study is to describe the association/correlation between change in~     patient-reported cognitive symptoms and work productivity in gainfully employed patients~     receiving vortioxetine for a Major Depressive Episode (MDE).~   "
55326|NCT02332941|"~     The purpose of this study is to determine if treatment of Age Related Macular Degeneration~     (AMD) with a new medication,rituximab is effective. To address this issue, investigators~     propose a clinical trial in which patients with late stage disease, poor vision and who have~     failed treatment by conventional means will receive rituximab by direct injection into the~     affected eye and will be followed for improvement in the structure of their retina. Age~     Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with~     routine care involving injections in the eye to improve and to prevent worsening of vision.~     However, some patients do not respond to the medications that we currently have and as such~     an alternative medication is needed. One potential medication is rituximab, which has been~     injected into the eye for primary eye cancer, and has been tolerated well and led to patient~     improvement. Investigators will obtain baseline eye tests then plan on injecting this~     medication in to the eye of our patients with late stage AMD, by first placing numbing drops~     into the eye, then injecting the medication directly into the eye using sterile techniques.~     Investigators will then follow the patient and repeat eye tests to monitor for improvements.~   "
55327|NCT02332928|"~     This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be~     randomized to receive either 20 mg oral melatonin or placebo the night before their first~     RT, nightly throughout their RT, and for an additional 2 weeks following the completion of~     their RT. After informed consent is obtained from eligible subjects, they will then be~     electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects~     will be stratified according to treatment duration (less than 3 weeks; equal to or greater~     than 3 weeks) and prior chemotherapy.~   "
55328|NCT02332915|"~     A growing neurorehabilitation literature suggests that intense treatment may be desired to~     maximize the effects of therapy following neurologic injury. This investigation is designed~     to facilitate the development of efficacious, clinically applicable treatment for acquired~     apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week~     vs. 3 hours per week, while holding total number of sessions constant) with a group of~     speakers who have chronic apraxia of speech and aphasia.~   "
55329|NCT02332902|"~     This trial is evaluating the use of oral Everolimus to determine if there is a reduction in~     the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6~     month period. The evaluation will be done by 3D photography measuring volume with the~     LIFEVIZ Micro system.~   "
55330|NCT02332889|"~     The main purpose of this study is to determine the safety of using the combination of~     decitabine and a cancer vaccine plus Hiltonol. The vaccine will be made from the subject's~     blood cells and is designed to interact in the subject's body with cells that are programmed~     to fight specific tumor proteins called NY-ESO-1, MAGE-A1 and MAGE-A3. The decitabine will~     be given to increase the amount and activity of these cancer proteins on the surface of~     tumor cells to increase the possibility that the vaccine will stimulate cells to act against~     the tumor cells. Subjects will be assessed to determine how these tumors respond to the~     treatment.~   "
55667|NCT02328495|"~     The aim of this study is to compare the effectiveness of misoprostol versus uterine~     straightening by bladder filling for pain relief in menopausal patients undergoing office~     hysteroscopy.~   "
55332|NCT02332863|"~     Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy~     (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification~     of target lesions in the pancreas via placement of fiducials using fine needle aspiration~     (FNA) needles. Currently, back-loading the fiducials is the only option for preparing~     delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with~     four fiducials has recently been developed, and used in a porcine models with successful~     results. There are no randomized controlled trials comparing total duration of time needed~     for placement of fiducials using technical success of the traditional back- loading~     technique of fiducial markers to the new preloaded needles in regards to EUS based fiducial~     marker placement for IGRT in pancreatic cancer.~      Hypotheses~      Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with~     pancreatic cancer will:~        1. Be delivered in at least require 60% less of the procedure time that it takes for~          traditional back-loaded 22G needles~        2. Improve overall procedure efficiency~        3. Maintain comparable technical success and adverse event rates.~      Primary Aims~      1) To compare the procedure time of 22G needle placement of three Visicoil (brand of~     flexible linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded~     fiducial markers.~      Secondary Aims~        1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and~          22G needle preloaded fiducial markers~        2. To compare endpoints of technical success defined as proper placement of two to three~          fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial~          markers and 22G needle preloaded fiducial markers.~   "
55333|NCT02332850|"~     This study will be conducted as a standard Phase 1b, open-label, multi-center study of~     patients with relapsed and/or refractory Myeloma who have received at least two prior~     therapeutic treatments or regimens. Throughout the Phase I portion of this study, a standard~     3+3 dose escalation design will be utilized. Two dosing cohorts will evaluate escalating~     doses SAR650984 (5mg/kg and 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose~     Carfilzomib (20-27 mg/mg2). Once a safe dose is established, an expansion cohort will~     further evaluate safety and begin to assess activity of this combination (SAR650984 (5mg/kg~     or 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose Carfilzomib).~      During the dose escalation portion of the study, the DLT period will be the first cycle (28~     days) or from Day 1 through Day 28 of initial study treatment.~      Expansion Phase Cohort An expansion cohort will begin once the MTD of SAR650984 plus~     standard dose Carfilzomib is established. The Expansion Cohort will enroll 18 patients for~     additional safety and preliminary efficacy data of SAR650984 plus Carfilzomib at the MTD.~   "
55334|NCT02332837|"~     Online trials require informed consent from participants. Massive online trials make~     face-to-face signed consent unrealistic and existing consent comprehension could be improved~     to increase participant safety and understanding.~      This trial will compare understanding of traditional digital consent with multi-media~     consent and with consent that is multi-media and interactive and uses a test and train~     model.~      The computer will assign participants to 1 of 3 methods to present online consent to~     participants~   "
55335|NCT02332824|"~     The primary objective of this study is to test the efficacy and safety on daily oral doses~     of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and~     microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison~     in order to determine the clinical dose of TAK-272.~   "
55336|NCT02332811|"~     Primary Objective:~      Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer~     carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease~     (CKD) patients both on haemodialysis and not on dialysis~      Secondary Objective:~      Evaluate the safety on the basis of adverse events, changes in laboratory values and vital~     signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)~   "
55337|NCT02332798|"~     This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in~     multiple ascending doses in subjects with stable schizophrenia.~   "
55338|NCT02332785|"~     With this study, the investigators plan to review the clinical, epidemiology, pathology, and~     endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of~     these lesions. The findings will help us define the natural history of colon serrated~     lesions, develop techniques for endoscopic management of patients with serrated lesions, and~     identity areas for improvement. The data will be used for continuing quality improvement and~     presenting our outcomes at academic meetings and publishing our results in peer reviewed~     journals.~   "
55339|NCT02332772|"~     With this study, the investigators plan to review the performance of colonoscopic resection~     of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role~     of colonoscopic resection of colon polyps and flat lesions and identity areas for~     improvement. The data will be used for continuing quality improvement and presenting our~     outcomes at academic meetings and publishing our results in peer reviewed journals.~   "
55340|NCT02332759|"~     The Materna device aims to prevent pelvic tissue damage by preventing overstretching of~     pelvic floor muscle fibers during delivery. The device is a single use, disposable,~     mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually~     expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a~     delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of~     labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision~     of trained clinical labor and delivery providers~   "
55341|NCT02332746|"~     The purpose of this study is to explore temporal relationships between self-worth and~     physical activity (PA) participation in middle-aged women (aged 35-64 years). We are~     particularly interested in the predictive role of self-worth on women's daily PA~     participation.~      This study will include two phases: a pilot phase to test the procedures and a test phase to~     assess self-worth and PA. During the test phase, Women will receive text message prompts in~     the morning, afternoon, and evening for 28 days on their cell phones. Each prompt will~     include a link to an 11-item mobile Internet-based survey assessing momentary PA,~     self-worth, and self-efficacy. Women will also concurrently wear an activity monitor~     (GENEActiv) to objectively measure their activity levels throughout the study.~   "
55342|NCT02332733|"~     The purpose of this study is to evaluate the safety of and immune response to two doses of a~     dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in~     Thailand.~   "
55352|NCT02332603|"~     This study evaluates the pathophysiological effects of a single dose of Methylprednisolone~     administered prior to total hip- and knee-arthroplasty surgery. The investigators examine~     the effect on blood glucose homeostasis.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the glucose homeostasis remains equally stable in the~     group receiving Methylprednisolone as in the group receiving placebo.~   "
55668|NCT02328482|"~     This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent~     control, parallel group study. Patients completing protocol BBCO-001 will be offered the~     opportunity to enter into this 12-month randomized withdrawal protocol.~   "
55343|NCT02332720|"~     This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172)~     (100 mg) and MK-3682 (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg) or ruzasvir~     (MK-8408) (60 mg), and with and without ribavirin (RBV), in treatment-naive (TN) or~     treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with~     hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to~     evaluate the safety of dose combinations. In Part B, participants will take 2 MK-3682B fixed~     dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily~     (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following~     completion of therapy in Part A will be offered the option of retreatment with 16 weeks of~     MK-3682B with RBV in Part C (data obtained from Part C will not be used in the analysis of~     outcome measures).~   "
55344|NCT02332707|"~     This is a randomized, three-part, open-label trial of grazoprevir (MK-5172) (100 mg) and~     MK-3682 (300 mg or 450 mg), with either elbasvir (MK-8742) (50 mg) or ruzasvir (MK-8408) (60~     mg), and with or without ribavirin (RBV), in treatment-naïve (TN) and treatment-experienced~     (TE) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic~     HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety~     of dose combinations. In Part B, participants will take 2 MK-3682B fixed dose combination~     (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg~     capsules; weight-based dosing). Participants who relapse following completion of therapy in~     Part A will be offered the option of retreatment with 16 weeks of MK-3682B with RBV in Part~     C (data obtained from Part C will not be used in the analysis of outcome measures).~   "
55345|NCT02332694|"~     Fibromyalgia has become an increasingly pressing public health problem in the United States.~     Although some treatments exist for Fibromyalgia, many individuals suffering with~     Fibromyalgia do not adequately respond to currently available treatment options,~     highlighting the need to develop and test new interventions for the disorder. To address~     this pressing clinical issue, we will conduct a pilot study to determine if Whole Body~     Hyperthermia (WBH) reduces symptoms in adults suffering from Fibromyalgia. We plan to~     recruit individuals with Fibromyalgia who will receive a single session of WBH to determine~     if this single session improves Fibromyalgia symptoms and if so whether this improvement~     will last at least 2 weeks. To do this, the study will include self-report symptom~     assessments immediately before and one and two weeks after WBH. In addition blood will be~     collected at these time points to explore whether WBH changes immune system chemicals that~     are believed to contribute to fibromyalgia. We intend to conduct the study until 10~     individuals with fibromyalgia have received a single treatment of WBH and have completed all~     pre-treatment and post-treatment assessments. Given scientific evidence from our research~     group that WBH may improve depression, we anticipate that it may also be of benefit or~     adults suffering from Fibromyalgia.~   "
55346|NCT02332681|"~     Osteoporosis is a systemic bone disease characterized by low bone mass and~     microarchitectural deterioration of bone tissue with consequent bone fragility and~     susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have~     an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that~     results from a low-energy trauma such as a fall from body height. A previous fracture is an~     important predictor of a new fracture, especially in the first 5 years after initial~     fracture. A second fracture can be particularly devastating if it is a hip fracture. Low~     bone mineral density, measured by bone densitometry, as well as a previous osteoporotic~     fracture, are the two major risk factors for the occurrence of a new fracture.~      A more rational approach currently used to minimize the costs of health care in a shorter~     period of time uses the strategy of firstly preventing the occurrence of secondary fracture,~     followed by primary prevention strategies. In this context, correct identification of~     fragility fractures and consequent treatment of those individuals is imperative. There are~     currently insufficient data about the epidemiology and evolution of other fragility~     fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius~     fracture and proximal humerus fractures are the most frequent. There is a type of fracture,~     however, that is simply ignored by the medical community: the knee insufficiency fracture.A~     possible explanation for this information gap could be the fact that, until a few years ago,~     this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming~     clear that the cause of pain and marrow bone edema that occur subtly in older individuals~     is, in fact, a insufficiency fracture. The perception that this lesion is actually a~     fracture is relatively new. The knee insufficiency fracture usually occurs in older~     individuals and those with knee osteoarthritis. This study therefore aims to evaluate~     whether there is a relation between knee insufficiency fracture and osteoporosis. Moreover,~     it is expected to find out if this fracture may be defined as a fragility fracture, electing~     the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic~     fracture.~   "
55347|NCT02332668|"~     This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have~     either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or~     advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant~     solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum~     administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for~     pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric~     RP2D.~   "
55348|NCT02332655|"~     The purpose of this study is to determine the tolerability and optimal dose of cannabidiol~     (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome~     (SWS) and drug resistant epilepsy.~   "
55349|NCT02332642|"~     This pilot clinical trial aims at evaluating immuno-modulating effects of palliative~     treatment with specifically dosed standard chemotherapeutics in patients with metastatic~     melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and~     activity.~   "
55350|NCT02332629|"~     This study evaluates the pathophysiological effects of a single dose methylprednisolone~     administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the~     effect on the endothelial glycocalyx shedding due to surgical trauma.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving methylprednisolone will experience~     reduction in glycocalyx degradation compared to the placebo-group, early after TKA.~   "
55351|NCT02332616|"~     This study evaluates the pathophysiological effects of a single dose of methylprednisolone~     administered prior to total knee-arthroplasty surgery. The investigators examine the effect~     on complement activation.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving methylprednisolone will experience~     beneficial inhibition of the undesirable parts of the complement activation.~   "
55416|NCT02331771|"~     This randomized, placebo-controlled trial will evaluate the use of donepezil compared to~     placebo to reduce the risk of memory impairment after electroconvulsive therapy (ECT).~   "
55353|NCT02332590|"~     Primary Objective:~      To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy with respect~     to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte~     sedimentation rate (ESR) in patients with active rheumatoid arthritis (RA) who are either~     intolerant of, or considered inappropriate candidates for continued treatment with~     methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are~     determined to be inadequate responders.~      Secondary Objectives:~      To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy in patients~     with active RA who are either intolerant of, or considered inappropriate candidates for~     continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous~     treatment with MTX, are determined to be inadequate responders, with respect to:~        -  Reduction of signs and symptoms of RA.~        -  Improvement in quality of life assessed by patient reported outcome questionnaires.~      Assessment of the safety and tolerability of sarilumab monotherapy (including~     immunogenicity) throughout the study.~   "
55354|NCT02332577|"~     Primary Objective:~      To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then~     1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after~     the end of treatment.~      Secondary Objectives:~      To evaluate the clinical efficacy in a subpopulation bacteriologically documented at~     inclusion and according to procalcitonin level.~      To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse~     and mortality 30±2 days after treatment is started.~      To document failures. To collect and follow up adverse events.~   "
55355|NCT02332564|"~     CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES Despite considerable advances in~     medicine, cardiovascular diseases remain the number one cause of death globally. In~     industrialized countries, coronary artery disease (CAD) is the leading cause of death,~     consequence of myocardial infarction (MI). Artificial - or natural - bypasses exert a~     protective effect by providing an alternative source of blood flow to a myocardial territory~     potentially affected by an acute coronary occlusion. Coronary collaterals represent~     pre-existing inter-arterial anastomoses and as such are the natural counter-part of~     surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals~     have been shown to confer a significant benefits in terms of overall mortality and~     cardiovascular events.~      EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY Commonly, coronary collaterals are implicitly~     understood to exist between coronary artery branches. However, the structural existence of~     coronary collaterals with an extracardiac connection has been confirmed by anatomical~     investigations. Pathophysiologically and with regard to a potential for arteriogenic~     stimulation, the connections from the internal mammary arteries, are of special interest.~      In a recently published work we have investigated the effect of temporary balloon occlusion~     of the distal IMA on coronary collateral function. There were equivocal findings for the~     left circumflex coronary artery: CFI was increased by ipsilateral IMA occlusion, but the~     level of myocardial ischemia was unchanged.~      MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES In our previous study, the coronary occlusion~     with simultaneous distal IMA occlusion was always performed first as a conservative measure~     against false-positive detection of internal-mammary-to-coronary artery connections.~     Repetitive coronary occlusions per se result in higher collateral flow by collateral~     recruitment and reduced ischemia by ischemic preconditioning and augmented collateral~     function. Conversely, the sensitivity of the employed method was reduced and might have~     contributed to the equivocal findings in case of the left circumflex artery. Moreover, the~     hypothesize d mechanism of localized pressure augmentation was not investigated.~      This study aims to further characterize the prevalence and function of natural ipsilateral~     IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of~     coronary collateral function augmentation by distal IMA occlusion. In our last study, the~     increased coronary collateral function in response to manipulation of a potential coronary~     collateral donor (in this case, the IMA) was taken as indirect evidence for the existence of~     IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion served as a~     positive stimulus. Conceptually, additional evaluation with a negative stimulus could~     heighten the discriminatory power of the investigation. This could be in the form of a~     hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary~     steal (ie, a reduction in coronary collateral supply to a collateral recipient).~   "
55356|NCT02332551|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress~     Free Survival (PFS) will be recorded.~   "
55357|NCT02332538|"~     Most guidelines are not strict for recommending single treatment approach for Moderate to~     large prostate.~      In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective~     Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar~     transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the~     Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a~     prospective randomized trial.~   "
55358|NCT02332525|"~     The purpose of this study is to investigate the effect of oral vibratory stimulus on the~     brain activity and cognitive function of elderly people with non-dementia subjects~     (cognitive normal, mild cognitive impairment)~   "
55359|NCT02332512|"~     Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2)~     tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and~     phase II clinical studies and found its promising anti-tumor activity and tolerable~     toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib~     phase II study in patients with NSCLC.~      The study aims to compare the efficacy and safety of apatinib to placebo in advanced~     non-squamous non-small cell lung cancer patients.~   "
55360|NCT02332499|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with metastatic colorectal cancer refractory to standard chemotherapies.~   "
55361|NCT02332486|"~     Due to the change of life style, the incidence of oral cavity mucous membrane disease~     increased.In this study，been done a large number of pre-clinical practice and some~     experimental studies， based on the application of metabolomics technology to ultra-high~     liquid-mass spectrometry metabolomics analyzer as the core means， The metabolism of pattern~     recognition and combination of modern analytical techniques to measure blood and urine of~     patients with OLP-specific clearance of endogenous metabolites，and after the intervention of~     moss drink endogenous metabolites in the body as a whole group of. At the same time， the use~     of flow cytometry,，ELISA， immunohistochemistry and other modern technology, research OLP~     patients using clean moss drink before and after treatment of local lesions and peripheral~     blood CD4 +，CD8 + lymphocytes，Th1 cytokines (IFN-γ， TNF-α)， Th2 cytokines (IL-4，10) the~     dynamic changes. From metabolomics， cellular immunology， inflammation mechanism perspective~     of local OLP lesions， peripheral blood and changes in endogenous metabolites in the~     process,，in-depth study of traditional Chinese medicine to drink clean moss multi-component~     multi-target treatment of this disease mechanism， is widely used in traditional Chinese~     medicine treatment of OLP provide a theoretical basis for the promotion of Chinese medicine~     Qingxian Yin in the oral mucosal disease in the application， effectively solve clinical~     practice problems.~   "
55362|NCT02332473|"~     This study is a multi-center, randomized, prospective open-label study to assess the~     efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in~     interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized~     to one of the 2 groups to receive different antiviral treatment.~   "
55363|NCT02332460|"~     Infliximab is the active ingredient in a drug currently sold by the trade names Remicade,~     Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical~     messenger (cytokine) in the immune system, and belongs to a class of drugs called TNF~     inhibitors. 8-55% of patients receiving infliximab have an infusion reaction. Infusion~     reactions are unintended reactions that occur during infusion of the drug and up to 14 days~     after. The incidence varies widely in different studies and seems difficult to determine due~     to variations in reporting of reactions, different definitions of reactions and~     retrospective data collection. The aim of this study is to estimate the incidence of~     infusion related reactions and investigate risk factors and immunological mechanisms of~     infusion reactions to infliximab in patients with a chronic inflammatory disease.~   "
55364|NCT02332447|"~     Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with~     drug-resistant epilepsy, with an incidence of about 0.4%/year. The diagnosis of SUDEP~     requires that anamnestic data and post-mortem examination do not reveal a structural or~     toxicological cause for death. Generalized tonic-clonic seizures (GTCS) are the main risk~     factor for SUDEP, which they appear to trigger in most instances. Indeed, experimental and~     clinical data strongly suggest that most SUDEP result from a postictal respiratory~     dysfunction progressing to terminal apnea, later followed by cardiac arrest.~      Postictal apnea could partly derive from a seizure-induced massive release of endogenous~     opioids. Animal studies suggest that such seizure-related release of endogenous opioid~     peptides participate to termination of seizures. In patients with epilepsy, functional~     imaging studies have confirmed that seizures induce release of endogenous opioids. The~     brainstem respiratory centers contain the highest density in opioid receptors, accounting~     for respiratory depression being one of the cardinal symptoms of opioid overdose.~      The investigators hypothesis is that SUDEP partly results from a post-ictal apnea promoted~     by a GTCS-induced massive release of endogenous opioids, and that an opioid antagonist could~     represent an effective preventive treatment of SUDEP. This could be achieved by chronic~     administration of Naltrexone, an opioid antagonist that has been used in a large population~     of patients with chronic alcoholism at high risk of seizures, without showing any~     pro-convulsant effect. This is a crucial feasibility issue since antagonising a mechanism~     thought to participate to seizure termination could theoretically aggravate seizures.~      Before evaluating the efficacy of chronic administration of naltrexone, it is legitimate to~     perform a proof of concept study by testing the acute effect of an equivalent injectable~     treatment (Naloxone) in the immediate aftermath of GTCS recorded inhospital during video-EEG~     monitoring of patients with refractory epilepsy. One third of these patients develop~     postictal respiratory dysfunction and hypoxemia, which should be reduced by the~     investigators intervention if the investigators hypothesis is correct.~      The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone,~     versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity~     of the postictal central respiratory dysfunction occurring after the end of the seizure, as~     measured by pulse oximetry.~      About 25% of patients with drug-resistant partial epilepsy who undergo long-term video-EEG~     monitoring develop at least one partial secondary generalized tonic-clonic seizure. However,~     these patients cannot be individualized a priori. Therefore, all adult patients with~     drug-resistant epilepsy who will undergo long-term video-EEG monitoring in one of the~     participating centres, will lack all exclusion criteria, and will give their written~     informed consent to participate to the study if they develop GTCS, will be included in the~     study. They will all benefit from continuous monitoring of pulse oximetry (together with~     video, EEG, and respiration recordings), and will be equipped with a peripheral venous~     catheter throughout the video-EEG. The modalities of the video-EEG monitoring will be~     consistent with the current practices and similar across the 14 centres (apart from the~     venous catheter which is not standard practice).~      In case of occurrence of a generalized tonic-clonic seizure, patients will be randomized~     (1:1) to receive intravenous naloxone (0.4 mg) or placebo. Placebo will be isotonic sodium~     chloride which preparation and packaging will be centralized to ensure its~     indistinguishability from naloxone. Randomization will be centralized and stratified by~     centre. The evolution from a partial seizure to a GTCS being gradual, and the total duration~     of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course~     of the seizure. Given the assumptions about the role of endogenous opioids release in the~     spontaneous termination of seizures, naloxone will be administrated immediately after the~     end of the GTCS and not before.~      All digital data (video, EEG, respiration, SpO2) will be centralized and evaluated blind to~     other data by the PI of the study who will not be involved in the video-EEG monitoring of~     the included patients. The same automatic and objective analysis of SpO2 data than the one~     already developed in the PHRC REPOMSE will be performed.~   "
55417|NCT02331758|"~     The purpose of this study is to explore the factors which affect ovarian response of PCOS~     patients with IVF-ET treatment, in order to provide predictive clinical index for the~     outcome of IVF-ET treatment in PCOS patients. After figuring out the controllable factors,~     researchers would be able to educate PCOS patients and improve the success rate while~     reducing the incidence of complications during the treatment at the same time.~   "
55418|NCT02331745|"~     This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of~     Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard~     treatment in combination, while half participants will receive standard treatment.~   "
55365|NCT02332434|"~     Rational: The world and french epidemic of obesity and diabetes represents a major problem~     of public health. The prevalence in France, in the adult population, is 15 % corresponding~     to 6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes.~     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.~     Cardiovascular diseases are the first cause of morbidity and mortality. The atherogenic~     dyslipidemia of these insulin-resistant obese type 2 diabetic patients characterized by the~     quartet: elevated plasma triglycerides, low high-density lipoprotein-cholesterol, increased~     proportion of small and dense low-density lipoproteins, is widely explained by the blood~     accumulation of TRL from the liver and the intestine, and represents a major cardiovascular~     risk factor. The overproduction of intestinal TRL (which apoprotein B48 is the specific~     tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role~     of these intestinal TRL has been shown. In view of this important overmortality and the~     failures of the medical, nutritional, dietary and psychotherapeutic combined treatment, the~     bariatric surgery quickly developed. Two main procedures are performed: 1 based exclusively~     on the gastric restriction (the sleeve gastrectomy) and one associating a malabsorption (the~     gastric bypass).~      Objectives: The main objective of this study is to compare the effect of each surgical~     procedure and the differential effect of the 2 bariatric surgery procedures on the~     production and clearance rates of the intestinal TRL. The secondary objectives are to~     compare the effect of each surgical procedure and the differential effect of the 2 bariatric~     surgery procedures on the production and clearance rates of the hepatic TRL and to document~     the potential links between the expected reduction of these productions after the surgery~     and the loss of weight, the improvement of the insulin-sensitivity, the changes in hormones,~     the decrease of the inflammatory state, the changes in energy expenditure, body composition~     and energy intake.~      Methods: It is a multicentric, prospective, comparative study of cohorts. After~     identification of the eligible subjects, the kinetics (production and clearance rates) of~     intestinal and hepatic TRL will be performed in the hospital, using established stable~     isotope enrichment methodology (5,5,5-D3-L-Leucine), in 2 groups of obese patients (15~     patients per surgery procedure), before and 6 months after the surgery.~      Perspectives: A better understanding of the dyslipidemia of obese type 2 diabetic patients~     and the factors modulating this dyslipidemia may lead to develop new dietary and/or drugs~     and/or surgical treatments targeted at the enterocyte to improve the lipid profile of these~     patients and reduce the incidence of cardiovascular diseases. Moreover, a differential~     effect between the 2 surgical procedures could help to choose the best surgical procedure~     for obese type 2 diabetic patients depending on the lipid profile at baseline.~   "
55366|NCT02332421|"~     In this study, two distractors will be used to retract maxillary canines into the extraction~     sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands~     connected to a canine and a molar; and the second one is a similar to the first one but with~     the addition of a third arm.~      The purpose of this investigation is to compare the two distractors in terms of: final~     position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the~     appliance.~   "
55367|NCT02332408|"~     Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic~     effect in the tumors of two radiotherapy schedules used for patients suffering from painful~     vertebral haemangiomas~   "
55368|NCT02332395|"~     The aim of this study is to determine the effect of surgical priority either emergency or~     elective on postoperative pain in caesarean section operations. Patients whose undergo~     caesarean section operation are included into this study. Patients will invite to complete~     the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be~     divided into two groups in terms of applied surgical priority whether emergency or elective.~     After caesarean section, patient controlled analgesia is used for pain relief. And the~     intensity of pain will be measured by using numerical rating scale.~   "
55369|NCT02332382|"~     The research subject~      Health organizations around the world have determined that breastfeeding is the most~     critical source of nutrition for newborns in the first weeks and months of their lives. A~     mother's breast milk contains unique nutritious components and other nonnutritive elements~     that help promote healthy baby growth and development (1, 2). Recent studies show that a~     mother's breast milk contains components that vary from each specimen. There are great~     evidences that maternal and environmental factors have a strong influence on the composition~     of breast milk. Fatty acids, the second most common component found in breast milk, show~     extreme sensitivity to maternal nutrition (3, 4).~      Latest studies show that breast milk also contains bacterial communities that may have~     health implications of newborn. The structure of these bacterial communities also varied~     greatly between subjects (5) .~      In the research, we propose to investigate the connection between maternal nutrition,~     different fatty acids and their role in the growth and development of bacterial populations~     existing in breast milk.~   "
55370|NCT02332369|"~     This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used~     during cataract surgery. Capsular Tension Rings are used during intraocular lens~     implantation to give added support in order to keep the intraocular lens well centered,~     especially in eyes with weak or partially absent zonules. In many cases, capsular tension~     rings allow a lens to be successfully implanted into an eye which otherwise could not have~     supported an intraocular lens, and have enabled patients to regain normal activities again~     after cataract surgery.~   "
55371|NCT02332356|"~     This randomized, controlled study aims to evaluate the impact of therapeutic intervention~     (step up) for the patients who are clinical remission with Magnetic Resonance~     Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step~     down for the patients who archived clinical and MREC remission. The primary endpoint is the~     rate of clinical remission at 104 weeks.~   "
55372|NCT02332343|"~     Dry age-related macular degeneration (AMD) is a common cause for severe visual loss in the~     elderly and represents an unmet need. So far no treatment is available for geographic~     atrophy (GA), which represents the advanced dry form characterized by expanding areas of~     outer retinal atrophy with corresponding absolute scotoma. The foveal retina may be spared~     until late in the course of the disease, a phenomenon termed foveal sparing. However, the~     disease process ultimately also involves the central retina leading to irreversible loss of~     central vision. While the natural history of eyes with GA has been extensively studied with~     regard to the entire atrophic area, morphology-function analyses for foveal sparing GA in~     particular are still missing. Such data are needed for various purposes including the future~     use in interventional pharmacological trials aiming to slow the progression of GA and to~     preserve the foveal retina. In this study, different imaging modalities for accurate~     detection and quantification of preserved foveal retinal areas will be assessed.~   "
55373|NCT02332330|"~     This study is designed to collect post market data on use of the VEST, particularly on~     saphenous vein grafts to the right territory of the heart.~   "
55374|NCT02332317|"~     The purpose of this study is to identify whether patients with newly diagnosed advanced~     cancer benefit from a 12-week palliative rehabilitation program integrated with standard~     oncology treatment.~   "
55375|NCT02332304|"~     To determine the relationship between the result of amniotic fluid optical density between~     26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress~     syndrome.~   "
55704|NCT02328014|"~     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and~     efficacy ACP-196 and ACP 319 in B-cell malignancies.~   "
55376|NCT02332291|"~     It can be difficult to achieve remission in individuals with late-life depression (LLD) and~     they often require aggressive treatment. This challenge is in part due to age-related~     vascular changes that are common in LLD. Successful antidepressant treatment involve changes~     across affective, cognitive, and default mode networks. We hypothesize that in LLD, vascular~     disease adversely affects response to antidepressants by disrupting connectivity of these~     networks. The primary goal of this project is to characterize how focal vascular damage~     affects regional connectivity and response to antidepressants. Based on past work and pilot~     data, we a priori focus on the cingulum bundle and uncinate fasciculus. These key fiber~     bundles connect frontal, temporal, and cingulate regions involved in cognition and affective~     responses. Our central hypothesis is that ischemic damage to the cingulum bundle and~     uncinate fasciculus contributes to structural and functional connectivity deficits of those~     tracts. This results in a disconnection effect that alters the function of connected~     regions. In turn, this increases the risk of a poor response to antidepressants.~      Our approach is to enroll up to 130 adults over age 60 years with a diagnosis of Major~     Depressive Disorder. Subjects will complete clinical evaluation, cognitive testing, and~     MRI/functional MRI (fMRI) sessions, including an fMRI emotional oddball task that includes~     attentional and affective components. Participants will be stratified by cerebral lesion~     severity and randomized in a 2:1 ratio to a double-blinded 8-week trial of escitalopram or~     matching placebo. Those who do not remit will transition to an 8-week trial of open-label~     bupropion, an antidepressant with a different mechanism of action. This will allow us to~     determine if different and distinct circuit deficits affect response to antidepressants with~     different mechanisms of action while also accounting for the placebo response.~   "
55377|NCT02332278|"~     To determine the effect in the post operative period of early feeding (4 hours after~     surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated~     cesarean section.~   "
55378|NCT02332265|"~     The purpose of this study is to evaluate a multilevel economic and food security program~     (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE) in rural central~     Malawi as implemented and assigned by CARE-Malawi on HIV vulnerability and other health~     outcomes.~      Hypothesis: HIV vulnerability can be reduced through a coordinated set of locally tailored~     individual and structural interventions that reduces poverty, reduces food insecurity,~     strengthens community bonds, and addresses gender inequality.~   "
55379|NCT02332252|"~     To determine the risk of surgical site infection after surgical skin incision, comparing~     electrocautery vs. scalpel.~   "
55380|NCT02332239|"~     The purpose of this randomized controlled study is to evaluate acceptability and~     feasibility, and to gather preliminary data about efficacy, of iDOVE, a brief emergency~     department introductory session + longitudinal automated text-message depression prevention~     program for high-risk teens.~   "
55381|NCT02332226|"~     The aim of this project is to evaluate a person-centred informational intervention aimed at~     parents of children with cancer.~      The following hypotheses will be tested: an informational intervention emanating from the~     parents' self-identified needs is associated to decreased illness-related parenting stress,~     decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety,~     decreased depression, increased satisfaction with information, and decreased number of~     health care contacts in parents.~   "
55382|NCT02332213|"~     The study is aimed to determine the potential of volatile marker testing for identification~     of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related~     precancerous lesions in the stomach and colon.~      The study will be addressing the role of confounding factors, including lifestyle factors,~     diet, smoking as well as addressing the potential role of microbiota in the composition of~     exhaled volatile markers.~   "
55383|NCT02332200|"~     This is a retrospective chart review with a short follow-up phone questionnaire for our~     patients who have been treated by Nationwide Children's Hospital physical therapy and sports~     medicine for a spondylolysis or spondylolisthesis injury.~      Currently, no research exists to guide referral for safe physical therapy rehabilitation for~     patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective~     study the investigators can gain information to better guide physical therapy referral time.~     This may also serve as foundation for a future prospective randomized trial.~      Currently, Nationwide Children Hospital physicians vary from immediate referral to physical~     therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective~     chart review assessing time to referral to therapy and patient outcomes the investigator can~     gain some guidance for when it is safe to prescribe physical therapy rehabilitation for~     patients with spondylolysis and spondylolisthesis injuries.~      Patients with an active spondylolysis or spondylolisthesis injury who are referred to~     physical therapy early will return to activity/sport sooner without increased risk of~     adverse reaction.~   "
55384|NCT02332187|"~     Patients that are on mechanical ventilators in medical intensive care units (MICU) have~     extremely weak leg muscles. Currently there is no treatment to prevent or reverse this~     weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg~     muscle strength and help patients regain leg function after knee surgery. The purpose of the~     present study is to determine if treatments with the All Stim 2 device can also improve leg~     muscle strength in patients on mechanical ventilation.~   "
55385|NCT02332174|"~     The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of~     single and multiple doses of rufinamide. The effects of food and sex on the PK properties of~     rufinamide in these Chinese volunteers were also evaluated.~   "
55386|NCT02332161|"~     Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and~     neck reconstruction after head and neck cancer removal. The procedure involves removing some~     muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of~     this study is to determine the impact of ALT on ambulation and activities of daily living~     (ADLs)~   "
55387|NCT02332148|"~     3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of~     the knee. This proof of concept study is a randomized, placebo-controlled, double-blind~     study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will~     self-treat for 30 days.~   "
55388|NCT02332135|"~     Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is~     developing rapidly. However, it is still unknown whether it is effective to accept microwave~     ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective,~     randomised control and paried clinical trial study, the investigators will observe the~     efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate~     secondary hyperparathyroidism. The patients in age-matched control group will accept active~     Vitamin D therapy.~   "
56061|NCT02323321|"~     To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts~     that may not meet current standard donor heart acceptance criteria (as identified above) for~     transplantation to potentially improve donor heart utilization for transplantation~   "
55389|NCT02332122|"~     A single center case-control study with 100 COPD patients will be organized to compare~     patients with and without bronchiectasis with regard to the presence of Aspergillus in~     sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be~     optimized for culture, Aspergillus galatomannan analysis and RT-PCR.~      This study is part of a larger project in which we assume that chronic respiratory infection~     by Aspergillus fumigatus and the accompanying immune response play an important role in the~     development of bronchiectasis in COPD. We suspect that this mechanism is controlled by~     vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.~      The present study is designed by the Laboratory of pneumology and will be conducted in~     collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic~     University of Leuven.~   "
55390|NCT02332109|"~     Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment~     of corneal edema caused by Fuchs' endothelial dystrophy.~   "
55391|NCT02332096|"~     Diagnosis and treatment of sleep apnea with continuous positive airway pressure (CPAP)~     therapy has been shown to decrease arrhythmia recurrence in patients with AF following~     ablation. However, patients with AF undergoing ablation are not routinely screened for sleep~     apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and~     perhaps higher among patients with AF. Home sleep testing is frequently used for evaluation~     of sleep apnea.~   "
55392|NCT02332083|"~     The goal of this randomized controlled study was to examine the effects of a 8 weeks~     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual~     virtual games [VG]) in the skilling up phase on physical performance, cognition and falls in~     elderly in need of care population.~   "
55393|NCT02332070|"~     1. To examine two main predictor variables independently and then jointly in stratified~          and multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and~          inpatient mortality, and the composite, as well as the outcomes of 30 day~          rehospitalization or death, and finally for the days out of hospital and alive adjusted~          to person-year of time~             1. Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)~             2. Thakar Acute Renal Failure (ARF) score (1 to 17)~        2. To examine the interrelationships between time in days between angiogram and surgery~          and the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality~   "
55394|NCT02332057|"~     The aim of this study is to determine the effectiveness of a combination of diclofenac and~     lidocaine gel in reducing pain during IUD insertion.~   "
55395|NCT02332044|"~     The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and~     Bepotastine besilate in healthy adult volunteers.~   "
55396|NCT02332031|"~     To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and~     elimination of sorafenib and safety in healthy male subjects~   "
55397|NCT02332018|"~     Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower~     limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard~     dose protocol~   "
55398|NCT02332005|"~     An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in~     diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an~     oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the~     effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12~     months of treatment. Subjects will be assessed at screening and baseline, with office visits~     every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion,~     the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve~     conduction velocity that is expected to be demonstrated in the group randomized to placebo~     treatment for up to 12 months.~   "
55399|NCT02331992|"~     Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting~     around 2-4% of the middle aged population and is characterized by periodic collapse of the~     upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary~     treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper~     airway obstruction, acceptance of and adherence with therapy has been sub-optimal.~      Over the past decade, considerable research has focused on determining the factors~     responsible for poor CPAP adherence. Two key areas have been identified: patient-reported~     symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the~     importance of patient education and support. In addition we know that the patient experience~     during the crucial first days and weeks of their journey predicts longer term adherence.~      This study investigates the ability of an automated program that assists patients towards~     continuous positive airway pressure (CPAP) therapy adherence.~   "
55400|NCT02331979|"~     This trial will investigate the safety and utility of spinal cord neuromodulation to improve~     urinary bladder function in the context of spinal cord injury.~   "
55401|NCT02331966|"~     The tumors that cause oncogenic osteomalacia (TIO) express and release in the circulation~     phosphaturic factors such as fibroblast growth factor-23 (FGF-23) that decrease renal~     phosphate absorption through acting in the proximal renal tubule and decreasing Type 2a and~     2c sodium-phosphate co-transporter. They typically follow a benign clinical course and even~     in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis~     are very uncommon.~      In this study we aim to investigate the role of other molecular pathways such as ERK1, ERK2,~     mTOR, EGFR, MEK1, MEK2, VEGFR3, AKT1, AKT2, IGFR-1, IGFR-2, PDGFRA, PDGFRB, cMET, FGFR2,~     apart from FGF23, KLOTHO and PHEX, in the behavior of histopathologically benign mesenchymal~     phosphaturic tumors.~   "
55402|NCT02331953|"~     Postoperative delirium is an important problem in patients undergoing major surgery. The~     incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery.~     A study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is~     associated with postoperative delirium after on-pump cardiac surgery. This same perturbation~     likely also increases the risk for postoperative delirium after spine surgery, although~     there are little data that have evaluated this hypothesis. Therefore, this observational~     study was designed to explore the relationship between perioperative rSO2 and the delirium~     in elderly patients undergoing spine surgery.~   "
55403|NCT02331940|"~     The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the~     HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality~     in patients with COPD.~   "
55404|NCT02331927|"~     The primary objective of the two phase PERMAD trial is the evaluation of the impact of a~     personalized marker-driven treatment approach with early detection of progression and~     modification of treatment on cytokines and angiogenic factors (CAF) and efficacy.~      In regard of the two parts, the primary objective of the run-in phase (n=50 patients) with~     conventional switch of chemotherapy together with the anti-angiogenic agent is the~     determination of a distinct cytokines and angiogenic factor (CAF) profile during treatment~     with FOLFOX and bevacizumab, which allows early detection/prediction of progressive disease.~     The primary objective of the marker-driven randomized part (n=150 patients) with~     marker-driven switch of antiangiogenic agent and maintenance of chemotherapy is the~     evaluation of the efficacy of an early marker-driven switch of anti-angiogenic treatment~     (bevacizumab to aflibercept)~      This is a multicentre, multinational, open labeled, prospective, randomized, controlled~     phase II study designed to assess the clinical utility of an early marker driven change of~     anti-angiogenic treatment (bevacizumab to aflibercept) maintaining the chemotherapy backbone~     until definite radiological progression in first line treatment of patients with metastatic~     colorectal cancer. After completing the run in phase of the study, with at least 30 patients~     completing their first line treatment (due to progression, secondary resection or toxicity)~     and being evaluable for CAF analyses, the results will be reviewed by an Independent Data~     Monitoring Committee (IDMC). Based on that review the decision to continue with, modify or~     cancel the randomized part will be made.~      The primary endpoint of the run-in phase with conventional switch of chemotherapy together~     with the anti-angiogenic agent is:~      • Progression free survival (PFS1) of first line treatment~      The primary endpoint of the randomized part with marker-driven switch of antiangiogenic~     agent and maintenance of chemotherapy is:~      • Progression free survival rate at 6 months (PFSR@6) after first cycle after randomization.~   "
55405|NCT02331914|"~     Gastrointestinal stromal tumors (GISTs) belong to the sarcoma group and are characterized by~     oncogenic mutations in the c-KIT, PDGFRA, BRAF and NF-1 genes that drive tumor growth. Since~     tyrosine kinase inhibitors (TKIs) have become available, the median survival of GIST~     patients increased from 9 months to over 5 years. Consequently, this rare disease has become~     a role model for other targeted therapies. However, response to TKIs is extremely~     heterogeneous: ~15% of the patients experience no benefit from imatinib, whereas ~17% of the~     patients enjoy stable disease for over 9 years. Treatment failure due to primary and~     secondary resistance is caused in part by mutations in oncogenic genes that cause change in~     drug sensitivity. A new technique, using circulating tumor DNA, has enabled us to assess~     mutations in a simple blood sample obtained from patients on treatment, and thus detect new~     mutations early in the course of the disease. Also, differences in pharmacokinetic drug~     behavior add to the observed heterogeneity, and may cause resistance due to drug~     underexposure and thereby proliferation of the least sensitive tumor cells. This offers the~     opportunity to optimize and personalize targeted treatment for individual GIST patients by~     timely treatment adaptation based on early detection of secondary TKIs resistance mutations.~     Achieving this urgently requires data on daily clinical practice, including prospective~     serial mutation analysis and serial drug plasma concentration measurement. At a fundamental~     level this will also help to unravel the driving factors behind primary and secondary TKIs~     resistance in this model disease.~   "
55406|NCT02331901|"~     This study examine the possible microstructural changes in the middle brain after mTBI using~     diffusion MRI~   "
55407|NCT02331888|"~     Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When~     necessary according to clinical indications, the scalp electrode will be connected. Tracing~     will be recorded simultaneously from all three devices until delivery.~   "
55408|NCT02331875|"~     The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and~     pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative~     patients with operable Squamous Cell Carcinoma of the Oral Cavity .~      43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose~     of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.~     Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated~     after the last administration of IPH2201.~   "
55409|NCT02331862|"~     Purposes of this study will be as follows:~        1. To design a prospective, randomized, and open-labeled study to investigate the effect~          and the side effect of MPD in combination with conventional antibiotics to affect~          clinical course, outcome, and medical expenses.~        2. To compare level of the urinary and serum cytokines before and after received MPD for~          the following sub-aim:~      I. To determine the population who is benefit from MPD to reduce the severity of clinical~     course and subsequent renal scarring.~      II. To understand the mechanism by which the MPD could shorten the clinical course and~     reduce the renal scarring.~   "
55410|NCT02331849|"~     Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution~     Manometry before and after medical treatment - motility is suspected to change/improve after~     therapy.~   "
55411|NCT02331836|"~     Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the~     adenoma detection rate (ADR)~   "
55412|NCT02331823|"~     Multi-center, prospective study is performed to investigate the efficacy of new short-course~     regimen for retreatment pulmonary tuberculosis patients.~      To obtain optimized short-course regimen, decrease treatment cost and improve success rate.~   "
55413|NCT02331810|"~     Primary Objective:~      Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell~     subsets compared to placebo.~      Secondary Objectives:~      Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability~     and safety of SAR113244.~      Assess in male and female lupus patients:~        -  The pharmacokinetics of SAR113244.~        -  The pharmacodynamics of SAR113244 for the following disease parameters:~             -  Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus~               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus~               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus~               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index~               (if applicable), Lupus-quality of life and Functional Assessment of Chronic~               Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and~               anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte~               sedimentation rate and C-reactive protein.~             -  Peripheral blood B and T cell subsets.~   "
55414|NCT02331797|"~     Minimally invasive surgery is becoming more common in many surgical fields. The wide view of~     endoscope allows for minimally invasive transcanal approach instead of large postauricular~     opening. The investigators conduct this study to compared post operative pain score (by~     Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and~     endoscopic lateral placing tympanoplasty.~   "
55415|NCT02331784|"~     The primary objective of this study is to evaluate the effects of the experimental treatment~     (cognitive training) further outlined in this protocol on the cognitive abilities (e.g.,~     processing speed, attention, working memory, and executive function), brain functionality,~     functional status and quality of life of individuals with age-related cognitive decline as~     compared to a computer-based active control.~   "
55419|NCT02331732|"~     This trial aims to increase the wellbeing of tuberculosis patients and their adherence to~     medication in Chisinau, The Republic of Moldova. The design is an individually randomised~     controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of~     treatment. The trial will have two arms; 200 patients will form the control group and~     receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive~     Virtually Observed Treatment (VOT).~      VOT differs from DOT in that the daily observation of patients taking their medication will~     be observed via internet video messages rather than in-person. Based on a small sample of~     patient interviews we think that for some patients DOT may be a hindrance rather than a~     help. VOT allows patients to take their treatment in the comfort of their home and means~     they don't have to travel to their polyclinic every day.~      There will be a central VOT observation centre where VOT observers will view and respond to~     video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health~     app. The VOT observers will also respond to the patients by sending feedback to the~     patients. The trial duration will depend on the recruitment rate of eligible patients but is~     expected to take 16 months.~   "
55420|NCT02331719|"~     Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%,~     and 80%-of survivors are physically disabled with high rates of cognitive impairment and~     depression.~      In an effort to address the issues with conventional treatments, a new integrated systematic~     approach has been developed. This approach utilizes an educational process where specific~     core competencies (pillars) of mapping, navigation, access, optics and automated resection~     have been integrated into a single standardized system to deliver targeted therapy for an~     individual patient based on location and patient factors. This system has demonstrated~     safety and efficacy in oncology patients and is also FDA approved for use in the ICH patient~     population as well.~      This registry will collect data form multiple site that preform the MiSPACE procedure as~     part of clinical care. The intent of this registry is to collect data on the economic impact~     as well as clinical outcomes using the MiSPACE approach with the integrated technology in~     the early treatment of ICH.~   "
55421|NCT02331706|"~     This trial is designed to determine the feasibility of conventional induction chemotherapy,~     IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.~   "
55422|NCT02331693|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric~     antigen receptor that can specifically recognize EGFR overexpressed in tumor cells is safe~     and effective for patients with EGFR-overexpressing malignant glioma.~   "
55423|NCT02331680|"~     This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral~     administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal~     failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume~     of at least 500 mL/day.~   "
55424|NCT02331667|"~     The main aim of this intervention study is to test the effect of diet on improvement in~     cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly~     allocated into two groups, one consuming prepared meals with herring or mackerel for four~     months, and one group consuming meals containing meat as a control group.~   "
55425|NCT02331654|"~     Pain represents one of the most common symptoms of Multiple Sclerosis (MS) that can~     seriously affect patient health-related quality of life.~      Central neuropathic pain, the main form of pain in MS patients, represents a significant~     clinical problem, in consideration of its poorly responsiveness to available therapies.~      Direct Current Stimulation (tDCS) is a non-invasive, well-tolerated procedure with an high~     and well documented neuromodulation activity at Central Nervous System (CNS) level. First~     evidences obtained by animal, neurophysiological and clinical studies suggested its~     potential efficacy in neuropathic pain treatment.~      In particular spinal DCS (sDCS) has been proven to modulate Nociceptive Withdrawal Reflex~     (NWR), an objective and sensitive tool to explore pain processing at the Spinal Level and~     recommended by European Federation of Neurological Society (EFNS) to evaluate the analgesic~     effect of treatments. In this order of view the investigators' objective is to investigate~     sDCS efficacy in MS neurophatic pain treatment applying validated clinical scales,~     neurophysiological acquisitions and specific biological marker dosages.~   "
55426|NCT02331641|"~     The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in~     patients with colorectal liver metastases (CLM) is object of debate. We build a study, using~     the propensity score matched analysis, to compare the short- and long-term outcome of the~     tow groups of patients.~   "
55427|NCT02331628|"~     Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification~     in Traumatic Brain Injured (TBI) patients~      Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known~     late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is~     used in various medical situations and is being tested for feasibility of use in TBI~     patients.~   "
55428|NCT02331615|"~     Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often~     suffer from executive dysfunction and behavioral disturbances. These types of injuries often~     involve axonal damage to pre frontal brain areas, which mediate various cognitive and~     behavioral functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction,~     orbitofrontal circuit lesions lead to personality changes characterized by disinhibition and~     anterior cingulate circuit lesions present with apathy. Patients who suffered traumatic~     frontal lobe damage often demonstrate a lasting, profound disturbance of emotional~     regulation and social cognition.~      Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes~     in the human motor cortex. this effect depends on the stimulation polarity and is specific~     to the site of stimulation. Interacting with cortical activity, by means of cortical~     stimulation, can positively affect the short-term cognitive performance and improve the~     rehabilitation potential of neurologic patients. In this respect, preliminary evidence~     suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect,~     and other cognitive disorders.~      Several possible mechanisms can account for the effects of tDCS and other methods on~     cognitive performance. They all reflect the potential of these methods to improve the~     subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks.~     It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk~     during ambiguous decision making.~      In this tDCS study the investigator uses one anode and one cathode electrode placed over the~     scalp to modulate a particular area of the central nervous system (CNS). The stimulation is~     administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a~     micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified~     medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on~     people.Electrode positioning is determined according to the International EEG 10-20 System.~   "
55429|NCT02331602|"~     The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban~     compared with dabigatran in patients with atrial fibrillation.~   "
55432|NCT02331563|"~     A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III~     were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D~     (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general~     anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the~     abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption~     were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4,~     5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of~     postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.~   "
55433|NCT02331550|"~     To evaluate the rate of regression and progression of low-grade squamous intraepithelial~     lesion comparing expectant vs. ablative treatment.~   "
55434|NCT02331537|"~     The purpose of this study is to examine if an internet-based exposure therapy is effective~     in reducing excessive worry amongst patients who suffer from this problem.~   "
55435|NCT02331524|"~     There are few studies that demonstrate how to best improve daily activity in people with~     heart failure (HF). Exercise alone has been shown to be ineffective, but other techniques~     such as daily activity feedback with encouragement or health coaching may be helpful. This~     research study will investigate two different treatment approaches for improving daily~     activity: 1) daily activity feedback and encouragement, and 2) health coaching with an~     individualized home exercise program. Both treatment approaches are hypothesized to result~     in improved daily activity compared to a control group.~   "
55436|NCT02331511|"~     The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in~     the prevention of venous obstruction after implantation of cardiac pacemaker or~     defibrillator.~   "
55437|NCT02331498|"~     A phase I/II study of pazopanib in combination with temozolomide in patients with newly~     diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)~   "
55438|NCT02331485|"~     Aim of the study is to assess the role of negative pressure therapy in the prevention of the~     complication of the laparotomy wound in the high risk patients group.~      Primary outcome: Reduction in wound infection rate by 50%~      Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound~     management Decrease cost of patient treatment~   "
55439|NCT02331472|"~     This study is to evaluate the efficacy of urine biomarker in patients with interstitial~     cystitis/painful bladder syndrome~   "
55440|NCT02331459|"~     Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it~     is not known physical training pattern more beneficial for these patients. The reasons for~     heterogeneity and lack of consistency of the results described by published intervention~     programs may be the diversity of isolated - resistance, endurance or proprioceptive~     trainings - or a combination of them. There are no studies with a combined program of this~     three kinds of physical training.~      The objective of this study is to know if a multicomponent physical training program during~     180 days in dwelling-community frail geriatric patients can improve scores on functional,~     activities of daily living, mood, cognitive and quality of life scales and producing changes~     in blood levels of biological and genetic markers.~   "
55441|NCT02331446|"~     The investigators will do an intervention on four groups of previously sedentary~     post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol;~     group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical~     protocol; group 4 - sedentary control women. The protocol consists of three sessions per~     week of concurrent training (half session with aerobic training and the other part with~     weight training). Inflammatory and oxidative parameters will be analyzed and the~     investigators hypothesized that 90 minutes per week of concurrent training (group 1) will~     reduce the inflammatory parameters and the oxidative stress, and this improvements will be~     greater so much as the longer the sessions (a dose-response effect). The physical activity~     practiced out of the intervention will be controlled by a questionnaire (the commuting and~     leisure sections of the International Physical Activity Questionnaire) and the food intake~     by a 24-hour food recall.~   "
55442|NCT02331433|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     APN1125 when administered as single doses to healthy adult subjects.~   "
55443|NCT02331420|"~     To assess the impact of weight loss due to bariatric surgery, as compared to the effect of~     optimal medical therapy alone on endothelial function, subclinical atherosclerosis,~     cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study~     consists in a 2-arm randomized trial, in which patients will be randomly assigned to~     bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0)~     and 12 months thereafter (T1).~   "
55444|NCT02331407|"~     Stroke is a leading cause of neurological disability worldwide, often causing significant~     weakening and paresis of the affected arm. National spending on post-stroke rehabilitation~     is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke~     therapy devices have the potential to be a cost-effective device aid to physical therapy and~     enable novel modes of exercise not currently available. While recent studies have shown~     chronic patients benefit from repetitive practice, it is not clear whether they improved via~     a reduction in impairment or increased functional compensation because there is a lack of~     standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients.~     This study aims to reconcile difference performance measurements in robotic rehabilitation~     to assess the outcome of robotic rehabilitation training.~   "
55445|NCT02331394|"~     The current proposal is a feasibility and acceptability study to establish the necessary~     groundwork for more detailed investigations into the role of CH in reducing symptoms and~     improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A~     standardized and easily administered form of CH will be used, incorporating a carefully~     selected combination of herbs designed to alleviate a range of common symptoms suffered by~     patients with advanced NSCLC.~   "
55446|NCT02331381|"~     The results of this imaging and treatment planning protocol will aid in developing~     procedures for patient localization and future clinical implementation of low-field MRI to~     confirm positioning prior to radiation treatment. Images acquired during this study may aid~     future study design for adaptive planning based on low-field MRI images. Moreover, results~     of this imaging and treatment planning may lead to guidance on optimal use of this novel~     device.~   "
55447|NCT02331368|"~     Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone~     pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are~     disappointing due to short-term response and long-term toxicities.~        1. Studies showed these patients have weak immune against MM due to the immune checkpoint~          mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody~          (anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading~          to killing of MM cells.~        2. Studies further showed enhancement of this unleash after autologous transplant and~          better MM control by anti-PD1 when used after transplant.~        3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe~          and effective and has been FDA-approved. Complications are of mild degree and easy to~          manage successfully in out-patient setting. Severe complications are rare.~      Thus, we are proposing an efficacy study of anti-PD1 treatment after transplant to improve~     MM treatment outcomes. This is a collaborative study with Medical College of Wisconsin~     (headquarter of Center for International blood and Marrow Transplant Research). We~     hypothesized that anti-PD1 treatment will increase the MM response and the MM control~     duration when it is added to the standard MM treatment after transplant. Anti-PD1 will be~     given at the dose and interval, which had been studied previously (200 mg intravenous~     injection every 3 weeks) between 2 weeks until 6 months after transplant. Subjects will be~     monitored closely during and after anti-PD1 therapy until at least 1 year post transplant.~     Late complications will be followed until 3 years.~   "
55448|NCT02331355|"~     There is an urgent need to develop hand transplant programs in this country. To this end,~     the University of Michigan Hospital and Health Systems is developing such an~     interdisciplinary program. The Transplant Center would like to track the patient experience~     from pre-operative care through surgery and post-operative care.~      Detailed information will be collected from the patient medical records, including:~     Pre-operative screening, demographics, medications; Surgical information ; Post-operative~     inpatient and out-patient care; laboratory and other test results; physical assessments,~     psychological assessments and quality of life assessments.~   "
55449|NCT02331342|"~     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method~     for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously~     showed promising results.~   "
55450|NCT02331329|"~     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The current standard methods for the determination of CO, however, are either~     invasive (e.g. right heart catheterization) or technically expendable and expensive~     (magnetic resonance tomography, MRT). Therefore, the aim of the study at hand was to~     evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare this new~     technique to MRT.~   "
55451|NCT02331316|"~     The purpose of this study is to find out if drinking extra water helps people lose or~     maintain weight loss and reduce hunger and, if so, what volume of water is most effective~     and when is it best to drink it.~   "
55452|NCT02331303|"~     The objective of this study is to evaluate the extent of potential off-label use of Xofigo~     in Sweden.~   "
55453|NCT02331290|"~     This study is designed to determine if changes in acetyl amantadine (AA) metabolism with~     systemic chemotherapy - reflective of SSAT1 activity - are predictive of response to~     systemic therapy in patients with lung cancer. Ten patients with adenocarcinoma and 10 with~     small-cell cancer who are at American Joint Committee on Cancer (AJCC) stages 3 or 4 at the~     time of diagnosis will participate. AA metabolites will be examined by ELISA prior to~     initiation of systemic chemotherapy and after the second cycle of therapy. Changes in the~     pattern of metabolites will be correlated with convention clinical and radiographic response~     criteria.~   "
55454|NCT02331277|"~     The primary objective of this trial is to investigate the safety and tolerability of~     multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy~     Chinese male volunteers.~      The secondary objective is the exploratory evaluation of the pharmacokinetics and~     pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for~     4 weeks in healthy Chinese male volunteers.~   "
55455|NCT02331264|"~     PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on~     cardiac function~      STUDY OUTCOME MEASURES~      To assess the effect of metal ions from hip implants on cardiac function as measured by~     Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate~     detection of cobalt ion deposition within cardiac tissues and assessment of ejection~     fraction and tissue characterization (with and without contrast).~      STUDY IMPACT~      With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK),~     and over a million worldwide, there is need to clarify this important question, which is the~     source of significant concern amongst patients and surgeons alike. Also, this problem is not~     unique to MOM hips since all hip implants contain metal and as seen in various case reports~     high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic~     bearing surface) leading to abnormal wear of the implant and release of metal ions into the~     body. In the UK, over 80,000 hip implants are inserted annually.~   "
55456|NCT02331251|"~     The Phase Ib and II cohorts will enroll patients with metistatic solid tumors.~      Phase II only will enroll the following patients:~      Patients with metastatic sarcoma to be enrolled in the following 4 arms: pembro plus~     gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine,~     and pembro plus liposomal doxorubicin.~      Patients with metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus~     gemcitabine and nab-paclitaxel arm.~      Patients with extensive-stage small cell lung cancer to be enrolled in the pembro plus~     irinotecan arm.~      Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm.~      Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm.~      Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus~     gemcitabine arm.~   "
55504|NCT02330627|"~     The proposed project aims to test the efficacy and neural correlates of a behavioral~     treatment program comprised of positive activity interventions in a sample of individuals~     seeking treatment for anxiety or depression. Participants will be randomly assigned to an~     immediate or delayed treatment condition, and will be compared on measures of positive and~     negative emotions, brain responses to reward and punishment/loss, subjective well-being, and~     symptoms at baseline and post-treatment.~   "
55457|NCT02331238|"~     This cluster-randomized school-based study will examine the effectiveness of a program for~     the primary prevention of perpetration of teen dating violence and sexual violence among~     middle school male athletes. Engaging men and boys in preventing violence against women and~     girls is recognized by major global health organizations as a critical public health~     strategy. Coaching Boys into Men is a theory- and evidence based program intended to alter~     gender norms that foster teen dating violence/sexual violence perpetration, promote~     bystander intervention, and reduce teen dating violence/sexual violence perpetration.~     Coaches receive a 60-minute training and biweekly check-in from a violence prevention~     advocate to administer the intervention to their athletes via 12 mini-lessons conducted~     weekly throughout a sport season. In a randomized trial of program effectiveness among high~     school athletes (Centers for Disease Control and Prevention CE001561-01, PI Miller), male~     athletes receiving the program demonstrated increased positive bystander intervention~     behaviors and less verbal abuse perpetration compared to controls. This project seeks to~     test the effectiveness of this program with younger male athletes in grades 6-8.The~     innovations are three-fold: (1) testing the efficacy of a novel teen dating violence/sexual~     violence prevention program for middle school male athletes; (2) training athletic coaches~     in Teen Dating Violence/Sexual Violence prevention thus implementing primary prevention that~     does not rely on teachers or classroom time; and (3) integrating the goal of changing gender~     norms with the technique of a bystander intervention approach to reduce teen dating~     violence/sexual violence prevention. The experimental design involves a 2-armed cluster~     randomized- controlled trial in 26 middle schools in Pennsylvania. Schools will be randomly~     assigned to either intervention or control (standard coaching) condition. Coaches in~     intervention schools will receive Coaching Boys into Men training. Baseline surveys will be~     collected for all intervention and control site athletes entering grades 6-8 at the start of~     each sports seasons across Year 1 (Time 1; N=2200 athletes). Follow up surveys will be~     collected at the end of each sports season (Time 2). All participating athletes will be~     re-surveyed 12 months after baseline (Time 3; final N =2000).~   "
55458|NCT02331225|"~     Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis~     of the skin and organs, inflammation, and an abnormal endothelial cell lining inside of~     vessels. A common and deadly complication of SSc is pulmonary hypertension (PH), which is an~     abnormal elevation in the blood pressure within the lung blood vessels. Early identification~     and treatment of PH is important in SSc, and no clinical factors can predict which patients~     will develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of~     increased amounts of endothelial microparticles (EMPs), which are substances circulating in~     the blood that were released from damaged vessel wall endothelial lining. A main goal of~     this study is to investigate if there is a difference in EMP levels between SSc patients~     with and without PH. The investigators will also use human endothelial cells in a lab~     environment to test whether these EMPs isolated from SSc patients are actually causing~     damage to the vessel lining. Lastly, the investigators will investigate the potential~     benefit of a medication used after transplant, mycophenolate mofetil (MMF). This will be~     done by causing damage to isolated human endothelial cells and treating them with MMF. The~     main goal of this portion of our study is to see if EMP levels are reduced when cells are~     treated with MMF. Overall, the investigators anticipate the following outcomes of this~     study: 1) use EMP levels to differentiation patients with SSc who have PH from those without~     PH, 2) use EMPs to understand how endothelial damage occurs in SSc, and 3) use EMPs to help~     us develop new treatments for patients with vascular diseases.~   "
55459|NCT02331212|"~     This research trial studies the role of a substance called hyaluronic acid in causing the~     growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells~     are a type of cancer cells that may cause the cancer to spread to other parts of the body.~     Studying samples of blood and bone marrow from patients and animal models in the laboratory~     may help doctors learn more about whether hyaluronic acid affects the growth of cancer in~     the bones.~   "
55460|NCT02331199|"~     The investigators will study 200 women with singleton pregnancies presented with prelabor~     preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar~     body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal~     pulmonary artery Doppler will be correlated with fetal outcome~   "
55461|NCT02331186|"~     Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate~     improvement of incontinency after weight loss. However, the mechanisms are still not clear.~     Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in~     women.~   "
55462|NCT02331173|"~     The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical~     setting to collect data on disease progression.~   "
55463|NCT02331160|"~     Breech presentation occurs in approximately 3-5% of all pregnancies, and breech birth is~     more complicated and risky for the fetus than births of fetuses in the cephalic position.~      Therefore, it is desirable to turn the fetus from breech presentation to cephalic position~     before labour. This is traditionally done by external cephalic version, where the doctor~     manually tries to turn the fetus; the success rate of this is approximately 50%, and~     complications occur in about 0.5%. In addition there is discomfort and pain to the pregnant~     woman.~      The investigators will assess the effect of using the rebozo prior to the external version.~     Use of rebozo is a recognized technique from Mexico, where the midwife with a scarf 'shake'~     the pregnant woman's pelvis over several sessions, so the fetus spontaneously turns to~     cephalic presentation or the external version is facilitated.~      There are no known complications associated with the rebozo method. Use of rebozo in breech~     presentation has never before been studied scientifically, but is used in many places in the~     world. The investigators are planning an open-labeled randomized controlled study in~     pregnancies with verified breech or transverse presentation: by lot either standard external~     cephalic version or preceding rebozo-treatment with subsequent external cephalic version.~      The investigators want to assess whether the use of rebozo - either as pre-treatment for~     external cephalic version or as a catalyst of spontaneous version - will increase the~     incidence of the cephalic presentations at labour and thus reduce the number of planned~     caesarean section.~      The population will be pregnant women with ultrasound verified breech or transverse~     presentation;all women who fulfill the local guideline criteria for external cephalic~     version, can be included. Exclusion criteria are non-Danish speaking or reading.~      The recruitment will be conducted by midwife at week 35 in the antenatal care. The study~     design will be open-labeled randomized controlled. Randomisation is done by closed envelope~     method and stratified by parity. Intervention is rebozo exercises performed over 3-5 days~     from randomization. In case of persistent breech presentation, the woman is offered standard~     external cephalic version. The control group will also be offered external cephalic version~     after 3-5 days from randomization.~      The investigators will use source data from existing local databases, Obstetrics Database~     and version Database, for collecting birth outcome. In all stages of intervention~     documented electronically by project midwives.~      The primary objective is the number of successful versions in total, i.e., after~     intervention and external cephalic version. We expect to increase the success rate from 50%~     to 65%, thus requiring 378 women in the study.~      Secondary objectives are the number of successful vaginal births with birth in head position~     and total number of caesarean.~   "
55464|NCT02331147|"~     This is comparison trial comparing human dermis to standard wound care for non healing~     diabetic wound~   "
55465|NCT02331134|"~     The overall goal of this study is to develop a pre-clinical platform of melanoma and head~     and neck squamous cell cancer that will allow the investigators to learn more about these~     diseases and discover better and more individualized treatments.~   "
55466|NCT02331121|"~     Unintentional injuries are the leading cause of death for children and infants under 14~     years of age. Many of these deaths are preventable, in part by promoting injury prevention~     behaviors but also by administering effective emergency first aid techniques until advanced~     care arrives. This project created a web site program that paired video-based instruction~     with interactive skills training to teach parents of children birth to 12 years old basic~     first-aid and CPR skills, and that included the option to practice skills as needed.~   "
55467|NCT02331108|"~     To compart differences on the effect on core temperature between anesthetic induction with~     intravenous propofol versus inhalation induction with sevoflurane~   "
55468|NCT02331095|"~     This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and~     randomized 1:1 into anticoagulation arm or anticoagulation plus atorvastatin arm, with~     atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80~     patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at~     The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment,~     3 months, and 9 months after randomization. At each follow up, blood will be obtained and~     assessments will include structured interviews of signs and symptoms of recurrent venous~     thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study~     drugs.~   "
55469|NCT02331082|"~     Globally, over seven million children under the age of five die each year, although a suite~     of interventions—safe delivery care, neonatal care and resuscitation, and management of~     childhood diarrhea, malnutrition, and pneumonia—can prevent many of these deaths when~     implemented within functioning health systems. This study will include a quasi experimental,~     stepped wedge, cluster-controlled trial of a mobile health care coordination and quality~     improvement intervention designed to facilitate comprehensive health systems strengthening.~     It will do this through training and equipping community-level health care clinics to manage~     chronic diseases through use of the Chronic Care Model, structured quality improvement~     sessions to promote clinical mentorship, and use of an integrated electronic medical record~     to provide real-time data for disease surveillance. The investigators hypothesize that~     improving upon the health system in these ways will lead to a 25% reduction in under-two~     mortality through improved services for the citizens of Achham, Nepal.~   "
55470|NCT02331069|"~     The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and~     triceps, with resultant pain and dysfunction. The active treatment for this study will be~     injection of the point of compression and along the painful course of the sensory nerve with~     5% dextrose. The control treatment will be physical therapy.~   "
55471|NCT02331056|"~     There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one~     lung ventilation. The overloading of fluid administration could be related to the~     development of pulmonary edema in patents after thoracic surgery. But fluid restriction may~     cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate~     the ability of stroke volume variation as an indicator for a fluid responsiveness in patient~     who receives pulmonary lobectomy via thoracotomy.~   "
55472|NCT02331043|"~     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.~     LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant~     stanols as esters per day) is less well known.~   "
55473|NCT02331030|"~     This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular~     brachial plexus block in patients undergoing arteriovenous graft creation surgery.~     Participants will be randomised into two equal groups, one receiving supraclavicular and~     pecs II blocks, the other receiving supraclavicular block and sham block (Grade 1).~   "
55474|NCT02331017|"~     To evaluate the combination of electric hearing through Cochlear Implant and acoustic~     hearing through hearing aid in bimodal users with moderate-to-severe hearing loss in the~     non-implanted ear. The research will also provide pilot study data on unilateral Cochlear~     Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic~     hearing has been preserved.~   "
55475|NCT02331004|"~     Investigators have created a protocol of intervention to treating the general disability of~     upper limbs.~   "
55476|NCT02330991|"~     The purpose of this study is to evaluate the clinical benefit and safety of two different~     Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous~     dose-intense regimen）in patients with glioblastoma at first relapse.~   "
55477|NCT02330978|"~     Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for~     several degenerative diseases, including retinopathies and glaucoma, however no previous~     safety study involving humans has been conducted. The objective of this study is to evaluate~     effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10~     patients with legal bilateral blindness due to glaucoma. Primary outcome are types and~     severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity,~     optical coherence tomography, and retinal ganglion cells function.~   "
55478|NCT02330965|"~     The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select~     immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal~     fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo~     treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled~     in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.~   "
55479|NCT02330952|"~     Primary objective:~      The aim of this study is to determine the efficacy and safety of five days of oral~     corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in~     outpatients.~   "
55480|NCT02330939|"~     The purpose of this study is to determine whether dietary fats may affect postprandial~     glycemic response differently according to their quality, and these effects may differ~     whether they are assumed in the context of meals with high or low glycemic index in patients~     with type 1 diabetes. This interaction between quality of fat and glycemic index of~     carbohydrates may have clinical implication for the calculation of prandial insulin dose in~     these patients.~   "
55481|NCT02330926|"~     Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle~     mass (with or without loss of fat mass) that cannot be fully reversed by conventional~     nutritional support and leads to progressive functional impairment.~      There is an urgency for improving management, but there is no consensus on the optimal~     treatment for cancer cachexia. Several single therapies for cancer cachexia have been~     examined in clinical trials, with disappointing overall results. As multiple factors are~     responsible for the development of cachexia, it has been argued that optimal cachexia~     interventions should target all components: multimodal therapy for a multimodal problem.~      The overall aim of this study is to early prevent the development of cachexia rather than~     treatment late in the disease trajectory. From a patient perspective a short term effect~     will be to improve physical and psychological function, to reduce symptom burden and to~     improve survival. In other words live a longer and better life during and after~     chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of~     weight and muscle loss, and improved physical activity and quality of life.~   "
55482|NCT02330913|"~     Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is~     gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy~     requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced~     for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method~     using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal~     resection and closure of common entry hole after anastomosis) was performed with only one~     stapler. Therefore, the novel method is simple and fast. Also, this new technique is better~     economically than previously introduced anastomosis using linear stapler because lesser~     number of stapler is required. We want to demonstrate the feasibility of novel~     intracorporeal anastomosis method during laparoscopic total gastrectomy.~   "
55483|NCT02330900|"~     Evaluation of electromagnetic interference between modern cell phones and contemporary~     implantable cardioverter defibrillators (ICDs)~   "
55484|NCT02330887|"~     In rural Nepal, the major drivers of underutilization of skilled birth attendance are~     poverty, poor social support and inadequate birth planning. Drawing from similar programs~     that have been shown to improve maternal and neonatal outcomes, we have designed a group~     antenatal care program that uses a participatory learning and action process to engage women~     in identifying and solving problems accessing maternity care services and create a~     supportive social network. We plan to test a group antenatal care program that will change~     antenatal care in three major ways: 1) conduct care in a group setting with women matched by~     gestational age, 2) incorporate participatory learning and action, and 3) provide expert and~     facilitated peer counseling.~   "
55485|NCT02330874|"~     In a recent study, which included 845 patients that at the time of ICU discharge had at~     least one risk factor for readmission, the investigators' group developed a new readmission~     risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and~     routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic~     Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve~     analysis, the investigators found that patients with a score above 14.5 had a high~     probability of readmission.~      The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a~     tool to predict unplanned readmissions to the intensive care unit.~      All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will~     be included in the study. The SD-ICU score is routinely calculated at the time of discharge~     from the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group~     1) and those with a score equal to or less than 14.5 (group 2). The two groups will be~     compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate~     logistic regression will be used to investigate the association between the risk factors for~     readmission used in SD-ICU score and ICU readmission as outcome.~   "
55486|NCT02330861|"~     Subjects are patients who are planned to do percutaneous coronary intervention for coronary~     stenosis in the left circumflex artery without other stenosis in the left ascending artery~     and the right coronary artery, or a patient with normal coronary artery. Immediately after~     coronary angiography or percutaneous coronary intervention, the investigators will evaluate~     for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary~     pressure and flow velocity with Combowire in each coronary segment. Also, they will assess~     coronary morphology by View It in each coronary segment.~   "
55487|NCT02330848|"~     Proposed is a randomized, controlled, modified Latin square parallel design study with two~     treatment arms to examine walnut consumption effects on diet quality, body composition, and~     markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A~     modified crossover design (Latin square)27-29 will allow for both paired and unpaired~     analyses.~   "
55488|NCT02330835|"~     This project evaluated a multimedia student behavior management program for school bus~     drivers and school administrators.~   "
55489|NCT02330822|"~     This is a randomized controlled trial with a split mouth design. Patients with an indication~     of lower dental extraction will be asked to join this research project at the Department of~     Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose~     case requires bilateral extraction, one side will serve as an experimental side, whereas the~     other side will serve as a control.~      Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic~     acid will be injected following extraction in one of the two sides with random allocation.~      cone-beam computerized tomography (CBCT) images will be taken for each participant~     immediately post-extraction and at six months post-operatively.~   "
55490|NCT02330809|"~     The purpose of this study is to find out if drinking extra water helps people prevent or~     relieve headaches and hunger and, if so, what volume of water is most effective and when is~     it best to drink it?~   "
55491|NCT02330796|"~     A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial~     designed to evaluate the safety and efficacy of two doses of Bucillamine compared with~     low-dose Colchicine in the treatment of patients with acute gout flare.~   "
55492|NCT02330783|"~     There is no standard treatment in patients with renal cell carcinoma that was previously~     treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a~     randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib~     versus sorafenib for the third-line treatment of patients with Metastatic renal cell~     carcinoma.~   "
55493|NCT02330770|"~     Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in~     women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin~     releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH~     agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual~     trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple~     luteal low-doses HCG~   "
55494|NCT02330757|"~     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation~     prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome~     (PCOS)~   "
55554|NCT02329964|"~     This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that~     is characterized by short operation time, required intense paralysis and ambulatory setting,~     has not been investigated.~   "
59574|NCT02277405|"~     The aim of the study was to compare time and success rates of four intubation devices in a~     cardiopulmonary scenario with and without chest compressions with a standardized pediatric~     manikin model.~   "
55495|NCT02330744|"~     The purpose of this study is to test the effects of a computerized approach/avoidance~     training (AAT) procedure on behavioral, affective, and brain mechanisms that are important~     for reward sensitivity and well-being in individuals diagnosed with major depression. The~     training procedure is designed to modify automatic approach responses for positive social~     stimuli. The primary aim is to determine the effects of approach/avoidance training on the~     functioning of brain systems during reward processing in individuals diagnosed with major~     depression. A secondary aim will determine whether brain activation patterns following~     approach/avoidance training predict subsequent affective and behavioral responses during~     reward processing. An exploratory aim will test whether completing the approach/avoidance~     training procedure in combination with a brief computer-delivered behavioral activation~     program for depression will produce larger changes in depression symptoms, positive~     emotions, and social relationship functioning from pre- to post-intervention compared to the~     control training procedure.~   "
55496|NCT02330731|"~     AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72%~     chromated glycerin with hypertonic glucose solution in management of gastric varices.~      METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams~     University Hospital were included. They were randomly allocated into three groups; each~     group included 30 patients treated with intravariceal sclerosant injections in biweekly~     sessions till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate;~     Histoacryl®), Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72%~     chromated glycerin; Scleremo® with glucose solution 25%). All the procedures were done~     electively without active bleeding. Recruited patients were followed up for 3 months.~   "
55497|NCT02330718|"~     The purpose of this study is to elucidate the factors which are associated with the~     diagnosis and predict prognosis and therapeutic targets by collecting specimens of tissue~     sample, peripheral blood, and bone marrow aspirates at the time of diagnosis or~     relapse/refractory in patients with malignant hematologic disorders except acute leukemia.~     This study is eligible for patients who are diagnosed with malignant hematologic disorders~     except acute leukemia or who will have diagnostic procedure with suspicion of having~     hematologic malignancy. Prospective cohort is for patients who are not in treatment for~     hematologic malignancy. Retrospective cohort is for patients who are diagnosed and in~     treatment.~   "
55498|NCT02330705|"~     Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG)~     administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.~   "
55499|NCT02330692|"~     Developing a molecular genetic test that can identify prognostic factors which can predict~     response to treatment, and to contribute to the establishment of future therapeutic~     strategies base on prognostic factors by undergoing peripheral blood and bone marrow~     examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.~   "
55500|NCT02330679|"~     Despite significant advances in pharmacological treatment, the global burden of depression~     is increasing worldwide. The major challenge in antidepressant treatment is the clinicians'~     inability to predict the variability in individual response to the treatment. The~     development of biomarkers to predict treatment outcomes would enable clinician to find the~     right medication for a particular patient at the early stage of the treatment and thus could~     reduce prolonged suffering and ineffective protracted treatment. Brain imaging studies that~     examined brain predictors of treatment response based on group comparisons have limited~     value in classifying individuals as responders or non-responders. Machine learning~     classification techniques such as the support vector machine (SVM) method have proven useful~     in the classification of individual brain image observations into distinct groups or~     classes. However, studies that have applied the SVM method to structural and functional~     magnetic resonance scans (fMRI) involved small sample sizes and were confounded by placebo~     responses. Furthermore, a recent meta-analysis of clinical trials and EEG studies have shown~     that early clinical responses and brain changes at the early phase of antidepressant~     treatment may predict later clinical outcomes suggesting that neural markers measured in the~     early phase of antidepressant treatment may improve predictive accuracy. However, there is~     no fMRI study to date that has examined the predictive accuracy of data obtained in early~     phase of the treatment. We have preliminary fMRI data relating to early treatment response~     that form the basis of this proposed study.~      The main objective of this study is to use machine learning method to examine the predictive~     value (sensitivity, specificity, accuracy) of resting state and emotional task-related fMRI~     data collected at pre-treatment baseline (week 0) and in the early phase of antidepressant~     treatment (week 2) in the classification of remitters (< 10 MADRS scores after 12 weeks of~     treatment) and non-remitters in patients with major depressive disorder (MDD). A secondary~     objective is to determine which data set (week 0 or week 2) gives the best predictive value.~   "
55501|NCT02330666|"~     Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for~     health problems that may compromise their futures and are extremely costly to society.~     Positive parent-child communication, characterized by openness, satisfaction with the~     family, caring, and effective problem-solving, has been found to be protective against a~     youth's involvement in health-risk behaviors. To promote positive adult-youth communication,~     in earlier work we developed, tested, and found efficacious an intervention, Mission~     Possible: Parents and Kids Who Listen (MP). This study is designed to test the following~     hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive~     communication when compared with adults who did not participate; (b) Youth who participate~     in MP will have a lower incidence of health-risk behavior when compared with youth who did~     not participate; and (c) Positive adult-youth communication will mediate childhood~     health-risk behavior in the presence of risk processes that predict participation. The~     experimental design is a 2-group (intervention and comparison) pre-test repeated measures~     design with six waves of data collection over three years and two booster sessions of the~     intervention. Elementary school and community centers in Madison and Chicago served as~     recruitment sites for parent-child dyads.~   "
55502|NCT02330653|"~     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment~     of safety and tolerability of universal donor FMT compared to placebo in pediatric and young~     adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) who have~     previously failed traditional, first-line maintenance therapy (aminosalicylates) or are~     intolerant to therapy. Secondary objectives include the identification biomarkers in both~     donor and recipient that may confer a clinical response and to establish whether or not~     ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric~     UC.~   "
55503|NCT02330640|"~     This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid~     dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients~     undergoing CABG surgery.~   "
55605|NCT02329301|"~     To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with~     DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD~     malaria case incidence and cohort infection incidence in areas of high and low malaria~     transmission and in a program-relevant manner that will permit adoption and adaptation for~     wider-scale deployment.~   "
55505|NCT02330614|"~     128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental~     School, Universidad de Chile, were included in the study. 58 patients were bleaching~     (experimental group) and 70 patients don't accepted the bleaching procedure (control group)~     were included in this study and signed a consent form.Experimental group Patients who agreed~     to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM)~     to each subject With verbal instructions for 3 weeks with daily applications of 1 hour~     according to manufacturers indications , before and after this procedure was applied again~     the NEO-FFI personality test form, had 30 minutes to answer it.Control group:Patients who~     refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to~     answer it.~   "
55506|NCT02330601|"~     The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up~     to 60% of patients had stone recurrence within two years after stone retrieval by ERCP.~     Although EPLBD is useful for for extraction of large CBDS with less operation time and~     mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in~     patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the~     short-term recurrence of CBD stones in patients with previous ES. It is a retrospective~     study with a small sample size (n=94).~      Here a prospective, randomized controlled study including two tertiary centers was designed.~     The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in~     patients with recurrent CBDS.~   "
55507|NCT02330588|"~     Childhood obesity is an urgent public health issue. Roughly one-quarter of Canadian children~     are overweight, putting them at risk for chronic diseases. Because most families access~     health services in primary care, it is an ideal venue for obesity prevention. Specifically,~     programs in primary care can prevent unhealthy weight gain in healthy weight children~     (primary prevention) AND reduce unhealthy weight gain in children who are already overweight~     (secondary prevention). Parents play a key role in children's health, so it is vital to~     include parents in strategies to prevent childhood obesity.~      The following objectives of this study are to: (i) develop a web-based, brief program for~     parents as an educational tool to motivate parents to support healthy lifestyles in~     children, and access community resources and health services that can prevent childhood~     obesity; (ii) assess the acceptability of the program using focus groups with parents, and~     pediatric-focused health care professionals, trainees, and administrators; and (iii) recruit~     parents (n=200) in primary care and collect data at baseline and 1-month follow-up to~     explore if the program led to changes in parents' motivation to support their children's~     lifestyle habits, and families' use of resources and health services to prevent childhood~     obesity.~      It is hypothesized that the developed screening, brief intervention, and referral to~     treatment (SBIRT) will (i) encourage parents of healthy weight children to seek resources to~     eat healthfully and be physically active to maintain their weight status (primary [1°]~     prevention), and (ii) guide parents of unhealthy weight children to access educational tools~     and community services to reduce their child's obesity and associated health risks~     (secondary [2°] prevention).~      By providing families with tailored feedback, practical educational tools, and information~     on local health services, this research will help to address oft-cited barriers primary care~     clinicians commonly report when providing effective obesity-related health services, and~     encourage family self-management of obesity-related behaviors.~   "
55508|NCT02330575|"~     The purpose of the study is to examine the benefit and specific outcomes of a~     community-based exercise program that is designed to address the needs of individuals who~     are receiving or recovering from cancer treatment.~      Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study.~     Survivors will be randomly assigned to one of two groups. The first group will take part in~     an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based~     exercise (early exercise group). The other 40 participants will continue with their normal~     activities for 16 weeks (delayed exercise group). After the 16 week period, participants in~     the delayed exercise group will take part in the 8-week supervised exercise program.~      Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise~     sessions will be supervised by specially trained exercise specialists who have received~     special training in exercise and cancer.~      Outcomes of the study will include feasibility, physical fitness measures, cancer-related~     symptoms and quality of life.~   "
55509|NCT02330562|"~     This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ)~     and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The~     study population includes subjects who are in first or second relapse and who have not~     previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor~     for treatment of malignant glioma. Phase 1 evaluates the combination of MRZ and BEV, while~     Phase 2 evaluates single-agent MRZ.~   "
55510|NCT02330549|"~     A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of CVC to be~     conducted in approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type~     2 diabetes mellitus and suspected NALFD.~   "
55511|NCT02330536|"~     Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing~     all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated~     chest cavity could increase lung collapse and improve surgical field view. The actual~     thoracic pressure values may not be identical with the presetting on the insufflator~     display. This overshoot pressure during VATS may compromise cardiac and pulmonary function.~     The purpose of this study is to evaluate the effects of intrathoracic pressure overshoot~     during two-lung ventilation on the hemodynamic and respiratory function and clarify the~     relative safety of two different techniques of insufflation.~   "
55512|NCT02330523|"~     To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked~     collagen membrane with xenograft + non-cross-linked collagen membrane for posterior~     extraction socket ridge preservation.~   "
55513|NCT02330510|"~     The prevalence of both Alzheimer's Disease (AD) and stroke doubles each decade over 65 years~     old. Both are major causes of dementia, currently estimated to affect 46 million people~     worldwide. The current costs globally are $818 billion. Additionally, in population studies~     elders over 65 years, covert cerebral small vessel disease appears on MRI scans as silent~     lacunar infarcts in 25% as Microbleeds in 10%, and as focal or diffuse 'incidental' white~     matter disease (WMD) in 95%. WMD is extensive in 20%, with a clinical threshold effect~     around 10cc2. Small vessel disease is even more common in dementia, often coexisting with AD~     and independently contributing to cognitive decline and progression to dementia.~     Longitudinal imaging using cerebral amyloid labeling opens a new opportunity to understand~     the additive/interactive effects of small vessel disease and AD.~      The design of this study includes recruitment of two cohorts, including Mild Cognitive~     Impairment (MCI) and/or early Alzheimer Disease subjects from memory clinics and subjects~     with strokes/TIA from stroke prevention clinics. Inclusion criteria include the presence of~     moderate/extensive white matter disease, eg. Fazekas score of 2 (with confluent~     peri-ventricular hyperintensities) or Fazekas score of 3, as determined by previous MR or~     CT, > 60 years of age, Mini-Mental Status Exam (MMSE) scores ≥ 20. Subjects will undergo 3T~     structural MRI (including T1, PD/T2, FLAIR, GRE, DTI, ASL, and resting state fMRI), glucose~     PET, amyloid PET (using AV-45 florbetapir) and neuropsychological testing, as well as blood~     sampling. Repeat MR and PET/CT imaging and neuropsychological testing will be conducted at~     24 months. The imaging portion is designed to closely parallel the Alzheimer's Disease~     Neuroimaging Initiative (ADNI) in order to benefit from the availability of both cognitively~     normal controls (NC), MCI and Alzheimer's disease subjects with minimal WMD.~   "
55514|NCT02330497|"~     Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that~     chance to discover a incidental solid or cystic pancreatic lesion is becoming usual.~     Endocrine tumors have variable malignant potential depending on their size, some malignancy~     for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN~     (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts~     represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs~     and risk of degeneration are the presence of mural nodules greater than 5 mm and size > 3~     cm, although the latter criterion is discussed. Mucinous cystadenomas could degenerate~     between 30 and 50% of cases even though the role of size is much discussed (<4 cm). The~     follow-up imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle~     aspiration for cytology and histology is possible and determination of biological markers is~     useful. But cytology is often unprofitable due to the poor cellular profile of the cystic~     pancreatic tumor. Once the diagnosis of suspected malignancy, the patient should be referred~     to the surgeon for pancreatic resection more or less extensive. But this attitude is facing~     a significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for~     cephalic resections. Some patients with high post operative risks are inoperable. For these~     reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or~     CT control by washing with absolute alcohol content of cystic tumor.~      An interesting alternative endoscopic destruction would be the use of radio frequency~     ablation technique (RFA). RFA is a recognized technique for local tumor destruction by~     delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™~     recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for~     applying RFA sub EUS control. But no prospective study is available at this date regarding~     the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The~     primary endpoint of the present study is to investigate the feasibility and safety of this~     guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or~     inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.~   "
55515|NCT02330484|"~     Based on patients' HbA1c improvement, this study aims to establish an incentive strategy to~     family physicians and patients respectively to evaluate the affect on the adherence to~     medication among patients with type2 diabetes.~   "
55516|NCT02330471|"~     In a randomized clinical trial of 120 women undergoing large loop excision of the~     transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray~     versus forced coagulation, will be compared. The primary outcome of the study is time to~     complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain,~     and postoperative bleeding complications.~   "
55517|NCT02330458|"~     Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness~     and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to~     predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's~     Disease.~   "
55518|NCT02330445|"~     Part A Primary Objective To determine the safety of six months of PRTX-100 administration.~     Part B Primary Objective To obtain antisera from normal volunteers that have developed~     anti-PRTX-100 antibodies.~      Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100~     treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of~     joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers~   "
55519|NCT02330432|"~     Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may~     play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in~     restoring immunity, thereby improving outcomes in patients with severe sepsis.~      In this randomized trial, the investigators propose to evaluate the efficacy of Mw in~     patients with severe sepsis.~   "
55520|NCT02330419|"~     This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of~     naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially~     diverse participants will be recruited using Respondent Driven Sampling as well as active~     field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug~     dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys~     will be completed monthly.~   "
55521|NCT02330406|"~     The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in~     reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and~     cardiovascular risk factors on statin.~   "
55522|NCT02330380|"~     This is a prospective longitudinal observational pilot study of psoriasis patients on~     continuous standard-of-care systemic therapeutics to determine the level of change in~     established (plasma/serum) and investigative (cellular) biomarkers that are associated with~     increased risk of CVD events.~      The final endpoint of the proposed study will be a ranking of the examined biomarkers based~     upon an integrated assessment of biomarker behavior over time.~      Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI,~     skin biopsies, and clinical improvement.~   "
55523|NCT02330367|"~     AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that~     selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while~     sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic~     (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010~     in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.~   "
55524|NCT02330354|"~     The purpose of this study is to evaluate the effect of a 7-month social marketing program -~     Healthy Me, Healthy We (previously called Our Year of Healthy Living) - in improving~     preschool children's (3-4 years) diet and physical activity behavior. Healthy Me, Healthy We~     will use social marketing approaches in the child care center to promote the use of healthy~     diet and physical activity behaviors by children, as well as their teachers and parents. The~     program will use visual cues, educational materials, activities, and a song to deliver~     targeted healthy behavior messages that connect the teacher, child, and parents. Centers~     will implement the Our Year of Healthy Living program in their classrooms over the course of~     a school year (October-April). Prior to initiation and after completion of the program,~     researchers will collect information about diet, physical activity, child body mass index~     (BMI), and center and home environment information from participants. From the beginning of~     the program to the end, children enrolled in the program will have 1) a greater increase in~     physical activity and decrease in sedentary time, 2) improved diet, and 3) smaller increase~     in body mass index compared to children in centers that do not complete the program.~     Additionally, from the beginning of the program to the end, homes and centers that~     participate in the program will have greater improvements in scores on the home and center~     environment assessments compared to centers and homes that do not participate.~   "
56062|NCT02323308|"~     The aim of study is to describe the clinical, immunological, serological, virological and~     therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to~     assess the response to vaccination in these patients.~   "
55525|NCT02330341|"~     The term prediabetes has been used to encompass the first alterations on glucose metabolism~     such as impaired fasting glucose and glucose intolerance, and its early detection and~     treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence~     disease worldwide.~      Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the~     treatment of diabetes.~      Different in vitro and in vivo studies have shown that Artemisia dracunculus increases~     insulin signaling and improves insulin sensitivity.~      The aim of this study is evaluate the effect of Artemisia dracunculus on glucose~     intolerance, insulin sensitivity and insulin secretion.~   "
55526|NCT02330328|"~     This is a randomized controlled, multi-center, non-blinded non-inferiority study examining~     the utility of telemetry monitoring in patients admitted who are low risk for acute coronary~     syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the~     study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their~     admission. Research study coordinators will enroll patients and then follow them throughout~     their hospital course and record primary and secondary end point events.~      The research coordinators will collect information on the following items for data~     collection: age, gender, smoking history, history of hypertension, history of diabetes~     mellitus, history of hypercholesterolemia, and history of family member with early heart~     disease or myocardial infarction, and body mass index. Research coordinators will document~     if the patient had any of the following events during their hospital course: death,~     myocardial infarction (MI), upgrade to a higher level of care, dysrhythmia, results of any~     stress testing or cardiac catheterization. In addition patients will be contacted at 30 days~     and 365 days to inquire about MI, needing for percutaneous coronary intervention (PCI), or~     revascularization (CABG).~      Based on previous studies, we hypothesize that patients aged 18-49 years who are at low risk~     for Acute Coronary Syndrome (ACS) are unlikely to benefit from continuous heart monitoring~     while admitted to the hospital for chest pain. We suspect that the rate of significant~     events may approach zero in this group of participants. This study aim is to show that a bed~     without remote monitoring- telemetry- is adequate when these low risk participants with~     chest pain are hospitalized.~   "
55527|NCT02330315|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and~     functional limitations in people with osteoarthritis of the knee. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
55528|NCT02330302|"~     Hip fractures are common in our elderly population and is associated with pain before and~     after surgery. The current pain management for patients who have undergone surgery for hip~     fractures include a combination of oral painkillers, opioids (eg morphine) and regional~     anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves~     supplying the hip joint to numb the operation site. As opioids have many side effects,~     especially in the elderly patients, regional anaesthesia techniques can help to reduce the~     use of opioids and the related side effects. This may enhance their recovery and length of~     hospital stay~   "
55529|NCT02330289|"~     Studies suggest that some laboratory tests ordered for hospitalized patients are duplicative~     or have limited value. This study will evaluate a normative feedback intervention to reduce~     overuse of laboratory tests for hospitalized patients by internal medicine~     physicians-in-training.~   "
55530|NCT02330276|"~     Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.~   "
55531|NCT02330263|"~     Surgical stress creates a state of insulin resistance which has been related to increased~     postoperative complications. Fasting before surgery induces a catabolic state that~     contributes to the development of insulin resistance. The aim of this study is to evaluate~     the effect of preoperative oral carbohydrates on postoperative insulin resistance in~     patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20~     to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30)~     groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100~     ml carbohydrate beverage in the evening before surgery and in the morning of the operation~     day (3 hours before their scheduled operation). In contrast, patients in the control group~     consume no food or drink after midnight before their surgery. The primary endpoints are~     postoperative insulin resistance measured by short insulin tolerance test.~   "
55532|NCT02330250|"~     This project aims to improve adherence rate through pharmaceutical care in patients with~     systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to~     improve the quality of life of these patients.~   "
55533|NCT02330237|"~     The aim of the study is to evaluate the safety and the therapeutic activity of the~     combination of Natural Gel combination and hair mask of plant origin in patients with mild~     to moderate plaque psoriasis.~   "
55534|NCT02330224|"~     High blood pressure (BP) is a serious public health problem responsible for heart attack,~     stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a~     pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component~     intervention and another usual care. A total of 100 adults with uncontrolled high blood~     pressure will be followed for 3 months. The intervention includes 1) algorithm-driven~     antihypertensive treatment for all patients using fixed-dose combination and lipid lowering~     for high risk patients, 2) motivational conversation for high risk patients; and 3)~     telephone based follow-ups of all patients by a team of physician supervised nurse~     practitioners and nurses. The change in BP will be compared between intervention and control~     groups. The structured care including the above mentioned components is likely to be more~     effective than usual care in lowering BP levels of patients with uncontrolled high blood~     pressure. Such a program is also likely to be more cost effective in terms of money spent~     for improving quality of patients' life. The findings of the pilot will inform the design of~     a larger cluster randomized trial in eight polyclinics in Singapore. If the main study is~     successful, the findings will be informative for policymakers to roll out intervention in~     all polyclinics and primary care centers across Singapore, and other countries with similar~     healthcare infrastructure.~   "
55625|NCT02329041|"~     Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for~     double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor~     double-lumen tube intubation. In this study, we will investigate its role in double-lumen~     tube intubation by comparison with another videolarygoscope.~   "
55535|NCT02330211|"~     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment~     of safety and tolerability of universal donor FMT compared to placebo in pediatric and young~     adult subjects (ages 5 years through 30 years) with active Crohn's colitis (CD) who have~     previously failed traditional, first-line maintenance therapy (aminosalicylates) or are~     intolerant to therapy. Secondary objectives include the identification biomarkers in both~     donor and recipient that may confer a clinical response and to establish whether or not~     ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric~     CD.~   "
55536|NCT02330198|"~     The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.~   "
55537|NCT02330185|"~     The most used anatomical landmark for application of spinal anesthesia is Tuffier's line.~     Other alternative landmark is tenth rib. However there is no trial that compare these~     landmarks based on using ultrasonography.~   "
55538|NCT02330172|"~     This study aims to make a comparison of surgical condition and recovery time between~     rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.~   "
55539|NCT02330159|"~     Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life~     and productivity. Thus, wound healing would have a significant effect on patient quality~     outcomes, patient quality of life, and healthcare utilization, as well as societal benefits~     from allowing this vital population to return to productivity. There is no consensus on~     postoperative wound care after surgery for PD. Negative pressure therapy is commonly used.~     However, this therapy is costly and cumbersome, and not evidence-based to optimize wound~     healing or postoperative patient or financial outcomes. The investigators goal is to~     investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia,~     MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem~     Wound Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare~     costs after surgical management of pilonidal disease.~   "
55540|NCT02330146|"~     The primary purpose of this study is to assess the safety profile of RCT-01 injections as~     compared to placebo injections. This study will also measure the impact these injections~     will have on tendon structure and function and the symptoms of Achilles tendinosis.~      28 participants will be selected for this study based on their health status, current/past~     medications, and ability to adhere to protocol-related requirements. Prior to entering the~     screening phase of the study, all potential study participants will have had to have at~     least 3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles~     tendinosis directed by a certified physiotherapist without a clinical response. At the first~     visit and after providing informed consent participants are evaluated against the study~     inclusion/exclusion criteria and provide blood samples for screening assessments (including~     virology). If suitable for study participation, participants will provide a biopsy from the~     scalp from which RCT-01 will be prepared.~      Baseline evaluations of participants' overall health and tendinosis, in particular, will be~     performed on the day of injection. Once all baseline assessments have been completed, the~     tendon to be treated will be anesthetized and will receive ultrasound-guided injections of~     either placebo (cryomedium) or RCT-01.~      All participants will return to the clinic for repeat assessments of their unilateral~     Achilles tendinosis and overall health at seven (7) visits over the following 6 months.~     Participants will also complete an eccentric training physiotherapy program under the~     guidance of a certified physiotherapist for two (2) months after receipt of injections.~     Total duration of patient participation is approximately eight (8) months.~   "
55541|NCT02330133|"~     Mid-life women, aged 35-50, are currently an underserved population in the areas of~     unintended pregnancy and STI prevention interventions. Common perception is that women in~     this age range are no longer sexually active, or are past the menopause transition, but in~     reality, sexual activity remains stable through mid-life and into the post-menopausal years.~     Additionally, physiological and relationship status changes (e.g. divorce or death of a~     partner) put these women at increased risk for both unintended pregnancy and STI's. This~     project developed and evaluated a theoretically-based multimedia intervention designed to~     assist mid-life women in protecting themselves from sexually transmitted infections and~     unintended pregnancy.~   "
55542|NCT02330120|"~     The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary~     mechanics in intensive care patients.~   "
55543|NCT02330107|"~     Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively~     affects the quality of life (QoL) of majority of the male aging population. Although LUTS~     are not life threatening, these symptoms include urinary retention, voiding difficulty,~     frequent feeling of urinary urgency, and nocturia, all of which negatively affect the daily~     functions, sleep quality, and sexual activities of patients. Despite the proven~     effectiveness of conventional pharmacological therapies, most men are reluctant to try these~     treatments because of perceived side effects and potential complications. Other non-invasive~     complementary treatments for LUTS should be explored because of the limitations of~     pharmacological therapy.~      Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a~     therapeutic method in which specific points in the auricle are stimulated to treat various~     physical disorders. AT is a specialized form of acupuncture in which the ear is viewed as a~     microsystem of the body. A minimally invasive measure of AT, instead of using needles, is~     adopted in this study to avoid pain induction.~      This randomized controlled trial (RCT) aims to determine the effectiveness of AT in~     improving the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL,~     and improving sleep conditions. Male subjects, who are 60 years old or above and with~     moderate to severe LUTS, will be recruited.~      Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points~     on one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will~     receive LA and placebo MAT using low-energy laser applied to selected acupoints of the ear,~     and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be~     given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA).~     Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that~     are considered to affect LUTS will be selected. Only one ear at a time will receive~     treatment. Thus, the ears will be treated alternately. The total treatment period will be~     four weeks. The experimental objects will be replaced every other day. Therefore, treatment~     will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after~     the therapy. This study can advance our knowledge of complementary approaches to improve the~     LUTS conditions of the elderly population and the feasibility of AT among clients with LUTS~     in a future large-scale study.~   "
55544|NCT02330094|"~     The purpose of this study is to see how much gabapentin will reduce headaches associated~     with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication~     prescribed.~   "
55583|NCT02329587|"~     This study is investigating whether combining noninvasive brain stimulation with behavior~     therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and~     response prevention (ERP) -- a specific type of behavior therapy -- is a first line~     treatment for OCD. This study will test whether a form of noninvasive brain stimulation~     called transcranial direct current stimulation (tDCS), can help ERP work better.~   "
55545|NCT02330081|"~     A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit~     will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then~     stored for 24h. At the end of storage, platelet concentrates will be separated from the~     unit, tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the~     donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets~     will be separated from this fresh sample and labeled with another radio-isotope. Then, the~     two radiolabeled platelet aliquots will be infused simultaneously and the recovery and~     survival of the two types of platelets will be measured.~   "
55546|NCT02330068|"~     The purpose of this study is to evaluate the feasibility of developing a microbiome probe of~     depression and to evaluate the microbiome change in a preliminary analysis of treatment~     response (n=20) vs. non response (n=20) to the antidepressant citalopram. This study is a 12~     week open trial that will enroll approximately 80 participants (anticipated 40 study~     completers with paired biomarker data) with an episode of major depression and 40 age- and~     sex-matched healthy controls.~   "
55547|NCT02330055|"~     The primary aim of the study is to evaluate the effect of the method of delivery (vaginal~     delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The~     investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean~     section compared with vaginal delivery, expressed as either the duration of SpO2 below 90%~     or the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations~     by at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a~     lower mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery~     group.~      The secondary aim of the study is to investigate how the upper body position during sleep~     (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first~     postpartum night.~      The investigators hypothesize that an upper body elevation to 45 degrees decreases the~     incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the~     ODI , compared with a non-elevated body position within each delivery group (vaginal~     delivery or cesarean section).~      The third aim of the study is to identify independent predictors of nocturnal desaturation~     in postpartum women. To that end, the investigators will administer questionnaires and~     collect demographic and clinical data according to various obstructive sleep apnea screening~     scores, including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will~     also ask the patient to rate the pain during the study night on a verbal numerical rating~     scale.~   "
55548|NCT02330042|"~     Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated~     with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the~     United States. Standard optical coherence tomography (OCT) cannot directly detect vascular~     changes, which may occur early affecting the passage of blood through the tiny capillaries~     (reduced capillary flow) or cause the greatest damage through formation of abnormal blood~     vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold~     standard for detecting these changes, but FA requires an injection of a dye into the vein of~     the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been~     used to make functional measurements (such as total retinal blood flow among others) and to~     perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate~     diabetic retinopathy.~   "
55549|NCT02330029|"~     The purpose of this study is to test the onset of action, offset of action, efficacy, and~     safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long~     term (over one year). Pinaverium has been in many countries, but there is no randomized,~     double-blind, large sample size, and placebo-controlled study on this medication yet. Tong~     Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used~     traditional Chinese medicine that can be used for IBS. The hypothesis is that the two~     remedies are effective and safe for IBS treatment with no significant different onset and~     offset of actions when tested by modern clinical standards and criteria.~   "
55550|NCT02330016|"~     This is a single center study of the safety and efficacy of Juvedérm Voluma for the~     treatment of hypognathism.~      Each qualified subject will undergo treatment with Juvedérm Voluma in the anterior and~     lateral chin for volume correction. Prior to treatment, the principal investigator will~     evaluate the severity of chin recession using a 90 degree image and a goniometer to measure~     the angle from the glabella to the chin. Subjects will be eligible for injection if the~     angle measures between 145 - 160 degrees. Facial digital photography will be captured prior~     to treatment and at each subsequent visit. The subject will complete a safety and injection~     site response (ISR) diary beginning on the evening of treatment.~      The subject will return at Day 3 and Day 14 after initial treatment, at which time the~     subject will undergo photography and the investigator will rate treatment improvement~     (GAIS). An independent image analysis technician will assess the degree of correction. The~     investigator will evaluate the treatment area for any adverse events (AEs).~      The subject will return 30 days after initial treatment, and the principal investigator will~     determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment~     may be administered. Facial digital photography will be captured prior to treatment and~     following treatment. The subject will return 3 days after the touch-up to undergo digital~     photography and for the principal investigator to assess safety/improvement.~      After initial or touch-up treatment, whichever is last, routine follow-up visits for safety~     and effectiveness will occur at 1 (30 days), 2, 4, 6, 9 (telephone call only) and 12 months.~     At all follow-up visits, facial digital photography will be captured and the investigator~     will rate treatment improvement (GAIS).. At screening and at Months 1, 2, 4, 6 and month 12~     subjects will complete the satisfaction of face overall module of the FACE-Q questionnaire.~      The goal of this study will be to assess the feasibility of Voluma XC for the treatment of~     hypoplastic chins~   "
55551|NCT02330003|"~     The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza~     Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled~     Syringe (inactivated split influenza vaccine) after single-dose intramuscular~     administration.~   "
55552|NCT02329990|"~     Phosphorus is a mineral that is naturally present in our foods and is required by our bodies~     for normal function. It has been found that phosphorus supplementation taken before meals~     has the potential to reduce meal size. However its long term effect has not been measured~     yet. It is well accepted that changes in body weight require about 3 months. Using body~     weight as the outcome, which is the ultimate outcome of weight loss approaches, would~     provide robust information on the role of phosphorus.~   "
55553|NCT02329977|"~     ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However,~     4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation~     due to chronic inflammation of biliary duct is generally considered an important cause of~     CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after~     sphincterotomy. Although it was believed that DBR was the important cause of CBDS~     recurrence, the direct evidence was still lacking. Here we conducted a case control study to~     investigate the DBR rate in patients with recurrent CBDS after ERCP.~   "
65093|NCT02205320|"~     This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy~     volunteers with three forms of pegylated granulocyte colony stimulating factors.~   "
55555|NCT02329951|"~     In this study, we are attempting to determine which factors are associated with~     interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP~     who are considered to be good candidates for therapeutic interventional procedures will be~     given a complete history and physical exam, which includes the assessment of Waddell signs,~     and querying them regarding factors shown in non-interventional studies or retrospective~     studies evaluating interventional treatments to be associated with negative treatment~     outcomes. These factors include the presence of Waddell and other physical exam signs,~     opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale~     on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation),~     procedure-related pain, obesity, and smoking history. They will then proceed to undergo~     their scheduled intervention, which will be limited to epidural steroid injections (ESI),~     facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint~     injections. A positive outcome will be defined as > 50% pain relief based on average pain~     score at 1-month and a score of at least 4 on a 1-5 Likert satisfaction scale. Those with a~     positive outcome at 1-month will remain in the study and be followed again at 3-months.~   "
55556|NCT02329938|"~     Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced~     as a pure tissue repair with no need for mesh. In other words; the complications which may~     arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the~     efficacy of this new repair and compare it to the standard Lichtenstein repair.~   "
55557|NCT02329925|"~     The coordination of swallowing and breathing is an important mechanism because the route for~     air and deglutition is partly shared in the pharynx. Tongue Stabilizing Device (TSD) is a~     preformed appliance for Obstructive Sleep Apnea (OSA) that protrudes the tongue and improves~     upper airway structure and function during sleep. Investigators will attempt to assess~     efficacy of TSD therapy on OSA and the physiological change of swallowing and breathing~     routes in OSA patients during sleep.~   "
55558|NCT02329912|"~     Postoperative ileus (POI) is a frequent complication after abdominal surgery leading to~     nausea, vomiting and infectious complications. Bowel dysmotility can last for days and~     necessitates parenteral nutrition resulting in an prolonged hospital stay and a high~     economic burden.~      Until now there is no evidence based therapy of manifest POI because of missing valid~     surrogate markers demonstrating the severity and resolution of POI.~      A novel tool to examine gastrointestinal function is the SmartPill®. By measuring pH value,~     temperature and intraluminal pressure the capsule is able to analyse gastric emptying, small~     bowel transit, large bowel transit and peristaltic activity.~      Unfortunately the use of the SmartPill® is not allowed in the first three months after~     abdominal surgery. Therefore a trial is needed to investigate the behaviour of the~     SmartPill® during its passage through the human gastrointestinal tract immediately after~     surgery.~      The primary endpoint is~      - to investigate the safety of the SmartPill® in patients after abdominal surgery.~      The secondary endpoints are:~        -  is the SmartPill® able to detect the gastrointestinal transit and the peristaltic~          activity followed by abdominal surgery compared with patients which underwent~          thoracic/vascular surgery.~        -  is it possible to correlate the measured parameters (delayed gastrointestinal transit,~          lack of peristalsis) with the clinical signs of POI (nausea, vomiting, prolonged~          duration until first postoperative defecation).~        -  is the detected peristaltic activity influenced by intravenous applicated prokinetic~          drugs~        -  is the detected peristaltic activity influenced by physiotherapy~      Using those endpoints the investigators hope to demonstrate the safety of the SmartPill®~     after abdominal surgery, to evaluate its ability to analyse severity and length of POI and~     to examine whether the used prokinetic drugs and postoperative mobilization are able to~     influence peristaltic activity.~   "
55559|NCT02329899|"~     Observational study aimed at evaluating the clinical impact of a standardised diagnostic~     procedure for the investigation of patients with suspected mild bleeding disorder (MBD).~   "
55560|NCT02329886|"~     China, efforts are underway to respond to an unprecedented epidemiologic transition, with~     soaring rates of cardiovascular disease (CVD), including heart disease and stroke. Yet there~     may be limitations in translating observations and findings derived from Anglo-based~     population studies. As such, there is a critical need for population-based studies that~     provide insight into the risk factors, incidence, and outcomes of CVD in China. The Qingdao~     Port Health Study is a population-based prospective cohort study of employees of the Qingdao~     Port Group, China, designed to investigate the burden of CVD and risk factors (e.g.,~     sociodemographic, biological, environmental and clinical factors) associated with disease~     onset and outcomes.~   "
55561|NCT02329873|"~     The purpose of this randomized controlled trial was to evaluate the effects of a respiratory~     rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum~     expectoration of hospitalized elderly patients with acute exacerbation of chronic~     obstructive pulmonary disease (AECOPD). Using purposive sampling, 61 participants were~     recruited and randomly assigned to either the experimental group (n = 30) or the control~     group (n = 31). The experimental group participants received the respiratory rehabilitation~     exercise training twice a day and 10-30 minutes per session for four days. The control group~     participants received usual care and health education. Data were collected at baseline and~     at the end of the four-day intervention.~   "
55562|NCT02329860|"~     This was a multicenter, randomized, double-blind, phase III trial. This clinical study~     evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who~     have progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy).~      Approximately 360 patients who meet the entry criteria will be randomly assigned in a 2:1~     ratio to Apatinib or placebo (1/3 chance to receive placebo).~      Primary endpoint of the study is overall survival.~   "
55563|NCT02329847|"~     The purpose of this study is to determine the safety and to establish the recommended phase~     2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic~     lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL)~     and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will~     be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety~     in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.~   "
55581|NCT02329613|"~     The main objective of this study was to evaluate and compare 6-month calorie intakes between~     a group of patients receiving a standard dinner and a group of patients whose evening meal~     is improved; compliance will be assessed on a food card with 5 levels of consumption: no~     (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days~     per month for 6 months and will, from the total calorie intake of each dish, estimate~     calorie intake ingested per day on all meals of the day.~   "
55582|NCT02329600|"~     The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral~     lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral~     lichen planus (OLP) patients who were treated with topical corticosteroids and green tea~     tablets.~   "
94479|NCT01820650|"~     This study is designed to observe the long term clinical outcomes of patient-specific knee~     arthroplasty in patients with osteoarthritis.~   "
55564|NCT02329834|"~     The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous~     and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent,~     they are both expected to achieve therapeutic plasma levels and induce effective diuresis.~      The test formulation in this study is a buffered solution, Furosemide Injection Solution at~     8 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the~     instructions in the protocol. A commercial formulation of Furosemide Injection, USP will~     serve as the reference drug in this study, which will be administered by IV bolus. It~     contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV~     and IM injection.~      The objectives of this study are:~        -  To characterize the pharmacokinetics of furosemide administered by continuous~          subcutaneous infusion using a biphasic delivery profile.~        -  To estimate the absolute bioavailability of furosemide administered by continuous~          subcutaneous infusion compared with an equivalent dose of furosemide administered by~          intravenous bolus administration.~   "
55565|NCT02329821|"~     The investigators are trying to investigate metabolism of lactate sourced from IV Hartmann's~     solution in patients with hepatocellular carcinoma(HCC) compared with a control~     group(donation for liver transplantation) with normal liver function. Second purpose of this~     study is finding the predictive factor of changing metabolism of lactate sourced from IV~     Hartmann's solution in patients with HCC.~   "
55566|NCT02329808|"~     This is a clincial validation study of a dried blood spot (DBS) method for the analysis of~     immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring~     (TDM) in a pediatric population.~      The primary goal is to clinically validate a finger prick DBS method compared to~     conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal~     drugs in the pediatric population. Secondairy goals include feasibility of the finger prick~     DBS method in the target population, to design an inventory of costs that will be incurred~     in future health-economic analyses and to construct a population PK model based on the~     available data collected for the primariy goal.~   "
55567|NCT02329795|"~     This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used~     to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and~     radiation treatment.~   "
55568|NCT02329782|"~     Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence~     intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the~     purpose of achieving and sustaining optimal levels of ART adherence and virologic~     suppression. Eligible participants will be randomized to receive either the ARP intervention~     or usual care (no intervention) and followed for 24 months.~   "
55569|NCT02329769|"~     The purpose of this study is to see whether PRO044 is safe and effective to use as~     medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44~     in the DNA for the dystrophin protein.~   "
55570|NCT02329756|"~     The objective of this study is to investigate the effect of tranexamic acid (TXA)~     administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly~     Adherent Placenta (MAP; placenta accreta, increta, percreta).~   "
55571|NCT02329743|"~     The primary objective of this study is to assess the efficacy and safety of 2 concentrations~     of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of~     ocular inflammation and pain in subjects undergoing cataract surgery.~   "
55572|NCT02329730|"~     Choose healthy subjects and patients with TB, distribute them into different dose groups~     according to the recombinant EC allergen dose from low to high average. Conducting clinical~     trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon~     gamma detection before the skin test，after the test 72h±2h and 144h±2h. Evaluate the safety~     of the recombinant EC allergy , and provide the appropriate dose range for phase IIb~     clinical trials.~   "
55573|NCT02329717|"~     This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of~     Nerium oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will~     receive PBI-05204.~   "
55574|NCT02329704|"~     This study evaluates the quality of sperm produced after semen processing using Density~     Gradient (DG) and swimming down (SD).~   "
55575|NCT02329691|"~     The main objective is to explore and evaluate the effect of a change in the WHO checklist on~     the safety climate in the operating room at a University Hospital in Gothenburg.~   "
55576|NCT02329678|"~     Introduction: The present clinical trial was conducted to evaluate the efficacy of membrane~     barrier in the healing of apicomarginal defects.~      Methods: Thirty patients meeting inclusion criteria were selected and allocated randomly~     into two groups: collagen membrane group and control group. Clinical and radiographic~     measurements were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12~     months after surgery. The criteria for success included the absence of clinical signs and~     symptoms, and complete or incomplete radiographic healing.~   "
55577|NCT02329665|"~     The primary objective of this study is to collect CT images of patients undergoing CT Guided~     Needle Intervention Procedures which will be used for the development of the NeedleWaysTM~     System.~   "
55578|NCT02329652|"~     This study is to evaluate the use of a fully implanted device for providing hand function,~     reach, and trunk function to individuals with cervical spinal cord injury.~   "
55579|NCT02329639|"~     Metastatic Breast cancer (MBC) patients from ten Italian Divisions of Medical Oncology, with~     histologically confirmed HER2-negative MBC, treated with a first-line therapy including~     bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v.~     on days 1,8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study.~     MBC patients treated with first-line chemotherapy including paclitaxel without bevacizumab~     will be also enrolled as control group.~   "
55580|NCT02329626|"~     The main objective of this study is to make a first evaluation of the relationship between~     metabolic abnormalities objectified by Positron emission tomography with~     2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH)~     performed at rest at the onset of symptoms in patients with a first episode of motor~     conversion disorder and the persistence of a motor disability at 6 months measured by the~     modified Rankin score (mRS).~   "
60866|NCT02260544|"~     Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are~     already receiving or who in the opinion of their treating physicians are candidates for~     Doxorubicin liposomal injection therapy .~   "
55584|NCT02329574|"~     Chronic pain is devastating both to individuals and society. In an aging population, surgery~     is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging~     from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one~     third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly~     determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that~     individual person-specific factors may play a more important role. In fact, recent studies~     indicate that individual differences in pain sensitivity (psychophysics) are more closely~     associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed~     that women who developed PPMP had lower pressure pain thresholds and greater temporal~     summation of pain stimuli than women who did not develop this chronic pain condition.~     Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and~     somatization were more prominent in women with PPMP. These preliminary, retrospective~     studies suggest that individual psychophysical and psychosocial characteristics could be~     important risk factors for PPMP. Accordingly, the aim of this study is to comprehensively~     and prospectively study women having mastectomy surgery, to determine the relationship~     between pre-operative psychophysical and psychosocial factors and the development of PPMP.~     Using these data, a prediction model for PPMP will be developed, thus allowing a~     preoperative calculation of a PPMP risk score for any patient facing mastectomy.~   "
55585|NCT02329561|"~     This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of~     tramadol and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using~     a randomised, double-blind, crossover design, participants were administered a single 200mg~     tramadol extended-release tablet and placebo.~   "
55586|NCT02329548|"~     This study uses an Alizarin Red powder mixture to characterize the sweat distributions in~     youth during tilt table testing. Patients with a known orthostatic sweat response from a~     prior clinical tilt table test in the investigators laboratory will be recruited. The~     Alizarin Red powder will be applied to exposed skin, and quantitative sweat will be measured~     at the thigh. During tilt testing, serial photos will be taken once the sweat response~     occurs. Sweat distributions will be compared during syncope (orthostatic sweat), during~     periods of anxiety (emotional sweat), and in patients with POTS (with and without syncope).~   "
55587|NCT02329535|"~     Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal~     progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton~     pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal~     morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators'~     hypothesis is that a higher dose of vaginal micronized progesterone will be more effective~     in preventing PTD. The objectives of the study is to compare the rate of preterm birth and~     perinatal morbidity and mortality in a twin pregnancy with short cervical length treated~     with vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized,~     open label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25~     mm. Women will be randomly assigned to either treatment or no treatment group. Progesterone~     treatment will be given until 36 weeks of gestation. Other management will be according to~     standard protocol.~   "
55588|NCT02329522|"~     Objective~      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for~     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of~     this study are:~        1. To investigate whether there is any correlation between haemodynamic parameters and~          COPD severity.~        2. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 6-month, 1-year, 3-year and 5-year readmission.~        3. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.~      Design, Setting and Subjects This prospective observational study will be conducted in the~     Prince of Wales Hospital in Hong Kong.~      Interventions Haemodynamic measurements made using the USCOM, and spirometry, will be~     performed as appropriate on subjects in respiratory clinic, the emergency department,~     medical wards and on ICU. In order to assess inter-observer variability, a second, blinded~     operator will repeated 15% of scans.~   "
55589|NCT02329509|"~     The purpose of this study is to evaluate which surgical protocol for treating Unilateral~     Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure)~     will have less impact in mid facial growth.~      The study hypothesis states that a two stage cleft palate repair , with a late hard palate~     repair will reduce maxillary growth impairment.~   "
55590|NCT02329496|"~     To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation~     Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients~     with severe calcific aortic stenosis who are considered high risk for surgical valve~     replacement.~   "
55591|NCT02329483|"~     This study aims to predefine the threshold FSH doses during the early follicular phases in~     low- dose step-up ovulation induction cycles used to treat anticipated high responders by~     monitoring total testosterone and androstenedione blood levels. The blood levels of total~     testosterone and androstenedione levels will be measured in patients at the starting day and~     at every control day when vaginal sonographic folliculometries and blood estradiol~     measurements are made. Hence, we are aiming to define an early monitoring parameter by which~     we will be able to define a follicular response to treatment before estradiol rise or~     apparently selected follicular growth.~   "
55592|NCT02329470|"~     A randomized, controlled study in parallel design recruiting 100 patients, 50 in each group.~     The patients have had CPAP (Continuous Positive Airway Pressure) treatment between 2 months~     to 2 years. The patients are investigated, then half of them (50 patients) are randomized to~     withdrawal of CPAP treatment during 3-5 nights followed by second investigation. 50 patients~     (control group) continue with CPAP but are investigated similarly than CPAP withdrawal group~     after 3-5 nights. The aim of the study is to investigate the effects of obstructive sleep~     apnea to arterial stiffness (primary outcome) and whether there is increase in insulin~     resistance, cathecol amines, if systemic inflammation occurs after short-term CPAP~     withdrawal, and what is the impact of age, gender and oxygen saturation on arterial~     stiffness (secondary outcomes).~   "
56522|NCT02317276|"~     The purpose of this study is to assess the differential expression of AD biomarkers in~     serum, plasma, and skin biopsies from both lesional and non-lesional skin in moderate to~     severe AD patients in the presence of TCS and after withdrawal from TCS.~   "
55593|NCT02329457|"~     Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with~     malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically~     manifested as herpes zoster (HZ), is a major complication that affects up to 50% of~     patients. Most patients will require hospitalization. Despite treatment with high dose~     acyclovir, patients may develop severe complications including the disabling postherpetic~     neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The~     median onset of infection is the fifth month following transplantation, with 91% of cases~     occurring within the first year. Direct vaccination of transplants recipients with~     subcutaneous live-attenuated VZVv before transplantation and up to one year after~     transplantation is contraindicated. A small prospective non-randomized study has~     demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection~     against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine~     delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic~     response in both healthy and elderly subjects. We sought to assess the efficacy and safety~     of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.~   "
55594|NCT02329444|"~     Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of~     contrast media use associated with prolonged hospitalization, cardiovascular events,~     persistent kidney damage and increased risk of all-cause mortality. When remote ischemic~     preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can~     be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised~     controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment~     and treatment of cardiovascular disease are randomized to receive RIPC or control sham~     preconditioning.~   "
55595|NCT02329431|"~     The goal of this study is to develop an intervention to teach activation skills to Latino~     parents who bring children for mental health services.~   "
55596|NCT02329418|"~     Relatives of patients in situation of withholding and withdrawing life-sustaining therapies~     often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when~     family members are active in this decision (81%) or when communication is not optimal~     between medical team and family members.~      There are several ways to assist families of patients in intensive care units [2], amongst~     them the use of a written document to explain the environment, therapies and possible~     outcomes.~      Here the investigators want to test the impact of a written document in the context of~     end-of-life conference in intensive care units. Specifically, this research addresses wether~     such written support could decrease 3-months post-traumatic stress disorder, anxiety and~     depression exhibited by the closest family member or the patient representative.~   "
55597|NCT02329405|"~     This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat~     content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR~     activator) and placebo will be given for a week to volunteers. Hepatic fat content is~     measured with magnetic resonance imaging and blood samples are collected at the end of each~     study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to~     the liver.~   "
55598|NCT02329392|"~     This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion~     pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac~     surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure~     with perioperative serum lactate level is going to be assessed.~   "
55599|NCT02329379|"~     1. To elucidate the therapeutic role of levothyroxine on the patient with atypia of~          undetermined significance (AUS) goiter, we would design a prospective, open label and~          non-randomized trial to verify the therapeutic effects on goiter with AUS by means of~          TSH (Thyrotropin; Thyroid-Stimulating Hormone) suppression related reduction of goiter~          volume with subsequent alleviation of previous cytological malignant tendency. During~          following for 1-2 years after therapy with simultaneous monitor of possible adverse~          effects of levothyroxine (eltroxin), we collected blood samples and gathered all~          necessary data as well as performed thyroid sonography with fine-needle aspiration~          (FNA) for the subjects. Furthermore, we would finish our individual study for each~          enrolled subject if his/her condition exhibited the criteria of primary end point:~          reduced goiter volume under sono >15% or cytology: benign for 2 times; operation for~          thyroidectomy, CAD attack, refractory arrhythmia, newly DM (Diabetes Mellitus), etc.~        2. To re-evaluate the current prevalence of goiter within Taiwanese adults, we recruited~          all patients who presented possible thyroid related symptoms, such as unexplained body~          weight loss with increased appetite, palpitation, hand tremors, neck swelling,~          hoarseness and abnormal sensation over throat. Only the patients with goiter proven by~          thyroid sono in euthyroid status without other preexisting major disorders can be~          enrolled in our trial to undergo open label, non-randomized study.~   "
55600|NCT02329366|"~     This project aims to result in the identification of such markers, and the development of a~     feasible quantitative method of distinguishing between tissue that has the capacity to heal~     and tissue that does not, thus identifying a non-healing phenotype.~   "
55601|NCT02329353|"~     Periodontitis is one of the most common chronic inflammatory disease with the etiology of~     bacterial plaque and is associated with a number of putative bacterial species. The~     periodontal destruction is substantially mediated by the host, driven by the bacterial~     challenge. The presence of pathogenic bacteria with the absence of so-called beneficial~     bacteria and the susceptibility of the host are the main aetiological factors of~     periodontal diseases.~   "
55602|NCT02329340|"~     Injuries are the leading cause of death and disability in children in America. Most injuries~     can be prevented when parents implement effective child safety practices. This project will~     create a behaviorally based program to teach parents what to do to prevent injuries to their~     school aged child, in an effort to reduce the number of injuries, hospitalizations, medical~     costs, and missed work days.~   "
55603|NCT02329327|"~     The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in~     patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The~     safety of andexanet will also be studied.~   "
55604|NCT02329314|"~     Collect the details about hepatic dysfunctional patients induced by various etiology who~     have a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the~     clinical curative effect of glycyrrhizic acid.~   "
55606|NCT02329288|"~     NAION produces an ischemic insult in the optic nerve head presumably due to the~     hypoperfusion of the short ciliary arteries that supply it.~      Intravenous injection of glucocorticoid have proven to be effective in treatment of~     Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the~     investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that~     might halt the progression of the visual acuity and visual field loss if our hypothesis is~     correct, would greatly improve their chances of avoiding blindness.~   "
55607|NCT02329275|"~     Azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20%~     azoospermia remains unexplained. The investigators suggest, that HPV may be an etiological~     factor in azoospermia and reduced sperm production.~      The investigators plan to examine the occurrence of HPV in testicular tissue from 100~     azoospermic men and to compare with the HPV occurrence in testicular tissue from a control~     group of 40 normal, healthy men undergoing vasectomy. Since HPV, in a recent Danish study,~     was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also~     plan to examine the occurrence of HPV on sperm ejaculated during the last week before~     vasectomy. If HPV should be found in testicular tissue from men belonging to the control~     group, it will be highly relevant to compare with the HPV occurrence on sperm ejaculated~     from the men in concern.~      A Linear Array HPV Genotyping Kit from Roche will be used for detection of HPV in testicular~     tissue and ejaculates. In total, with this test kit 37 HPV genotypes are examined for,~     including 13 high risk types.~   "
55608|NCT02329262|"~     This approach will train peer mentors to deliver a culturally appropriate intervention and~     provide social support that is critical for facilitating and sustaining health behavior~     change. The objective is to compare the efficacy of an innovative healthy lifestyle skills~     mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for~     increasing physical activity in Appalachian high school teens. MBA emphasizes the social~     determinants of health by using a social networking approach that trains peer mentors to~     support targeted teens~   "
55609|NCT02329249|"~     There is an important need for effective smoking cessation programs that both (a) promote~     the effective use of pharmacological aids, such as nicotine replacement products and~     bupropion, and (b) provide cognitive-behavioral support for stopping smoking.The Internet is~     an increasingly attractive intervention medium for delivering behavior change interventions,~     including smoking cessation.This study examined smoking cessation rates among adults~     participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom~     ™ program, a theoretically based, online smoking cessation program that included message~     tailoring and interactivity combined with the live personal support of a smoking cessation~     coach. Coaching support was provided almost entirely asynchronously via prescripted but~     individually tailored emails.~   "
55610|NCT02329236|"~     The aim of the our study is to investigate whether there is an increased incidence of ADHD (~     based on self reports and questionnaires) among children with short stature due to~     constitutional growth delay (CGD) in comparison with children with Familial short stature.~   "
55611|NCT02329223|"~     This was a Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult participants~     12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and~     who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.~   "
55612|NCT02329210|"~     Bardet-Biedl Syndrome (BBS) is a rare genetic disorder associated with a vast array of~     symptoms. The features of BBS are highly variable, even between siblings, making long-term~     follow-up and centralization of information vital to better understanding this complex~     disease and designing effective treatments.~      Marshfield Clinic has developed the Clinical Registry Investigating Bardet-Biedl Syndrome~     (CRIBBS) to gather comprehensive health information from patients diagnosed with BBS in a~     single repository. This information will be used to inform patients, families, and~     physicians about the complex features of BBS and will serve as a platform for researchers to~     develop effective and targeted treatment strategies for patients with BBS.~      CRIBBS is a web-based, confidential database and the privacy of patients enrolled in the~     registry will always be respected. Information maintained in the database will be~     identifiable only by an assigned study identification number, not by name. The registry~     strictly complies with HIPAA regulations. CRIBBS participants may be contacted periodically~     with information regarding clinical trials or research studies, but participation is~     entirely voluntary.~      CRIBBS will bring together complex genetic and clinical information from BBS patients to~     accelerate research into effective treatments, attract additional researchers, and make it~     easier for researchers to identify patients and find funding for innovative studies.~   "
55613|NCT02329197|"~     Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At~     the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins~     diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer~     catheter 10 minutes before embryo transfer procedure.~   "
55614|NCT02329184|"~     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and~     pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending~     (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.~   "
55635|NCT02328911|"~     The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy~     of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The~     hypothesis is that laser therapy will produce significant improvement on measures of~     self-reported pain among adults with diabetes.~   "
55636|NCT02328898|"~     The study objective is to assess the safety and efficacy of the Permanent Polymer~     Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent~     Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration~     will be applied in stable angina pectoris patients. Myocardial infarction patient population~     will be treated with 12 months of dual antiplatelet therapy.~   "
55637|NCT02328885|"~     Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the~     safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that~     consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the~     20 fraction (between 60 and 90 days after transplantation).~   "
55615|NCT02329171|"~     Rationale:~      Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer.~     High grade CIN (CIN 2-3) is currently treated by large loop excision of the transformation~     zone (LLETZ). This treatment has potential complications, such as hemorrhage, infection and~     preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed.~     Imiquimod (an immunomodulator) was proven effective in the treatment of HPV-related vulvar~     intraepithelial neoplasia (VIN) and may also be effective in HPV-related CIN. [van Seters,~     2012] However, the evidence is limited and study results are not consistent. [Grimm, 2012;~     Pachman, 2012; Lin, 2012]~      Objectives:~      Primary objectives: (1) to investigate the efficacy of imiquimod 5% cream for the treatment~     of CIN2-3 lesions and (2) to develop biomarker panels to predict clinical response to~     imiquimod therapy.~      Secondary objectives: to assess side effects of imiquimod treatment and LLETZ, disease~     recurrence and quality of life.~      Hypothesis:~      The investigators hypothesize that imiquimod will be an effective treatment modality in~     approximately 50-75% of CIN lesions treated without surgical intervention.~      Study design:~      Single-centre randomized controlled intervention trial.~      Study population:~      140 women with a histological diagnosis of CIN2-3, equally divided over two study arms.~      Intervention:~      Patients will be randomized into one of two arms:~        1. Imiquimod treatment arm. Patients in this group are treated by a 16-week regime of~          imiquimod 5% cream.~        2. Standard treatment arm. LLETZ will be performed on patients in this group.~      Colposcopy with diagnostic biopsies will be performed after 10 weeks for the imiquimod~     treatment arm. In case progressive disease, the treatment will be ended and appropriate~     surgical excision will be performed. Treatment efficacy will be evaluated after 20 weeks, by~     colposcopy with diagnostic biopsies. A histological biomarker panel will be developed,~     consisting of markers representing both host and viral factors.~      Main study parameters/endpoints:~      The primary endpoint of the study is regression-or-not of CIN2-3, defined as CIN1 or less at~     the colposcopy at 20 weeks for the imiquimod arm and PAP 1 cytology at 6 months for the~     LLETZ group.~   "
55616|NCT02329158|"~     The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches~     (HES) for patients undergoing cardiac surgery was safe and effective.~   "
55617|NCT02329145|"~     Chronic heart failure is becoming more and more common disease and activation of sympathetic~     nervous system plays a crucial role in its development. There is some data allowing to~     suspect that one of the new treatment methods- renal denervation, also in patients with~     chronic heart failure may lead to decrease of systemic activity sympathetic nervous system~     and, as a consequence, to decrease of disease progression. The research hypothesis is~     whether renal denervation in case of symptomatic heart failure, even the optimal treatment~     therapy is used (including resynchronization therapy), is contributing to the improvement in~     parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of~     the study is to obtain a new knowledge concerning renal denervation in chronic heart~     failure, So far only very limited data- mostly case reports- are available in this study~     area.~   "
55618|NCT02329132|"~     Recent reports suggest that anti-VEGF agents (ranibizumab) may suppress the progression of~     retinal nonperfusion area. This protective effect would cause the increase of the oxygen~     consumption in the diabetic retina. We expect that the current study using the retinal~     oximetry would show the protective effects of ranibizumab on the hypoxia in the diabetic~     retina. This study is designed to analyze the effects of ranibizumab (Lucentis) to the~     retinal oxygen saturation or consumption in eyes with diabetic macular edema.~   "
55619|NCT02329119|"~     Schizophrenia is considered as the most frequent and the most severe chronic psychotic~     disorder. Its evolutionary modes and its clinical symptomatology remain particularly~     heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from~     being clearly understood. Current empirical studies provide a mean duration comprised~     between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues~     are partly based on difficulties in the early distinction between schizophrenia and bipolar~     affective disorders (BD).~      These results emphasize the necessity of new early indices (or endophenotypes). Such markers~     are intended to be more specific than classical clinical manifestations. In other words,~     they have to be absent among patients with differential diagnosis, such as BD. Among other~     possible early indices, several electrophysiological disturbances have been explored.~      Our study is designed to mainly describe the N400 component among patients with~     schizophrenia or BD. This component is classically interpreted as indexing the integration~     the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to~     show a specific alteration of N400 component among patients with schizophrenia when compared~     to participants with BD.~      The second aim of this study concerns the exploration of four other event related potentials~     (ERPs) among patients with schizophrenia or BD:~        -  the P50 component, involved in early sensory gating processes,~        -  the P300 component, thought to reflect attentional resource allocation and working~          memory updating of stimulus context,~        -  the P600 component, elicited during same paradigms than N400, and reflecting their~          syntactic congruity.~        -  the CNV (Contingent Negative Variation), reflecting processes of motor anticipation~      Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400~     and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since~     the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also~     propose to describe the possible relations between these ERPs results and clinical scores~     observed among patients.~   "
55620|NCT02329106|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroportion in unresectable liver cancer close to diaphragmatic dome.~   "
55621|NCT02329093|"~     As we have previously reported, the primary cause of hip OA with accompanying joint pain~     might be bone alterations which can be microfracture. In order to prove it, it is planned~     that conservative treatment will be performed on the hip OA patients with accompanying joint~     pain for the first year. For the second year, if the patients still have joint pain, they~     will do non-weght bearing walk.~   "
55622|NCT02329080|"~     This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and~     feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy,~     followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.~   "
55623|NCT02329067|"~     The objectives of the proposed study are to assess whether the metabolic effects of walnut~     consumption depends on which food components the walnuts substitute (i.e. carbohydrates;~     saturated fatty acids) and whether it is important to consume walnuts as snacks or with~     meals.~   "
55624|NCT02329054|"~     There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are~     supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment~     of coinfections with antibacterial and antimalarial drugs, and blood transfusion when~     appropriate. Despite these interventions, mortality remains high since the ongoing Ebola~     outbreak in West Africa was declared in April.~      Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and~     polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA~     polymerase inhibitors. All these interventions are considered investigational due to lack of~     data in humans with EVD.~      In this study, the investigators chose to study the efficacy of favipiravir because this~     drug:~        -  showed anti-Ebola efficacy in immunodeficient murine models;~        -  has been studied in thousands of adult humans participating in anti-influenza trials,~          with good tolerance; it has been approved for treating novel or resistant influenza~          infections in Japan;~        -  is immediately available;~        -  can be used orally, and can be easily given in both adults and children because pills~          can be crushed and mixed in food or liquids;~        -  has recently been used in Europe for treating several patients with EVD; the French~          drug safety agency (ANSM) has reviewed published data as well as data provided by the~          firm (Toyama Chemical Co., Ltd), and approved its compassionate use in EVD.~      Here the investigators propose to assess the efficacy of high-dosed favipiravir in reducing~     mortality in humans with EVD.~      In the present trial JIKI (means Hope in Kissi language), investigators, sponsor,~     scientific advisory board and safety monitoring board will be coordinated in a very reactive~     way, so that any new fact can be discussed rapidly and the research plan can be adapted~     accordingly (change in drug dosage; use of drug combination; combination with another~     strategy such as passive immunization with convalescent plasma, etc.).~   "
55626|NCT02329028|"~     The EEG is widely used in the diagnosis of central nervous system pathology, including~     epileptic seizures and epilepsy. Presently, EEG is available only during office hours in~     most hospitals, pending on the availability of a clinical neurophysiologist and the lack of~     oncall possibility outside these hours. Standard EEG devices are large and their operation~     require meticulous application of several leads. The department of clinical neurophysiology~     at Helsinki University Central Hospital has developed a mini-EEG device for use in the~     emergency department as well as in the prehospital setting. The aims of this pilot study is~     to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a~     decreased level of consciousness, as evaluated by the emergency medical provider on the~     scene, are included. The mini--EEG device is to be used by a specially trained emergency~     medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes~     are used. The sample size is 30. Data are collected as a part of the clinical work in daily~     practice. The aim is to collect observational data on feasibility, no clinical interventions~     will be performed based on the EEG. No funding is needed as data is collected during daily~     work.~      The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central~     Hospital, and as such, does not have a trade name. It is to be connected to a~     monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by~     Physio-Control, Redmond, WA 98052. (www.physio-control.com)~   "
55627|NCT02329015|"~     The purpose of this study is to compare the academic and psycho-social benefits of a~     yoga-informed health and wellness program (HWP) to a standard physical education program for~     middle and high school students within New York City (NYC) schools.~   "
55628|NCT02329002|"~     Rationale: Hereditary retinoblastoma survivors have an increased risk to develop second~     primary tumors (SPT) at a later age (with the highest risk in their teens), especially when~     they have been irradiated for retinoblastoma. The investigators hypothesize that regular~     screening with magnetic resonance imaging (MRI) could lead to early detection of SPTs~     leading to improved survival.~      Objective: To evaluate the potential benefit of craniofacial MRI screening for early~     detection subclinical secondary cancers in patients previously irradiated for hereditary~     retinoblastoma.~      Study design: Prospective multicenter non-invasive screening study. The total study duration~     will be four years of screening plus five years of follow-up.~      Study population: Irradiated hereditary retinoblastoma patients 8-18 years old Main study~     parameters/endpoints: To evaluate the ability of craniofacial MRI for early detection of~     SPTs, the investigators will determine the sensitivity and specificity of MRI at detecting~     SPTs in irradiated hereditary retinoblastoma patients.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Included patients will undergo yearly craniofacial MRI for a period of 4 years.~     They will also be asked to fill out a psychological burden assessment form each visit. A~     potential risk of screening might be associated anticipatory anxiety, but screening also~     could be reassuring for patients and their parents; the investigators are not sure which~     will outweigh. False-positive results from MRI screening could lead to unnecessary further~     diagnostics leading to possible added anxiety and diagnostics (e.g., biopsies). However,~     this group of patients have a high risk of developing SPTs, with poor 5-year survival~     statistics. Early detection and therefore treatment of earlier stage (smaller) tumors, might~     therefore increase survival of this patient group.~   "
55629|NCT02328989|"~     For 25 years, the twin pregnancy rate has regularly increased in the majority of European~     countries and in the United States, by 35% between 1981 and 2006. Increased use of medically~     assisted procreation and older maternal age are the two main causes. At the present time~     twin pregnancies represent nearly 20% of premature deliveries. The rate of very premature~     births (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies.~     As prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity~     is the principal cause of neonatal mortality and of brain sequelae in twins, the search for~     a preventive treatment appears as a priority in perinatal medicine. The investigators~     recently showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks~     was a better predictive investigation of premature delivery < 34 wks than digital~     examination. Recently in a randomized trial in a population of short-cervix singleton~     pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with~     the usual management group. No other trial of pessary use in short-cervix twin pregnancies~     was published today. Recently, in a historical comparison of twins with twin-to-twin~     transfusion syndrome treated with laser, Carreras et al. have showed a decreased rate of~     preterm delivery with the use of pessary in case of short cervix. The investigators wish to~     set up a randomized multicenter study in France in the population of short-cervix twin~     pregnancies to show a potential benefit of the pessary compared with simple surveillance.~   "
55630|NCT02328976|"~     The purpose is to compare, using functional magnetic resonance imagery in resting-state, the~     connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of~     chronic migraineurs, studied outside a migraine attack and is compared to gender- and age-~     matched episodic migraineurs with very few attacks per month and studied in the attack-free~     period. The primary outcome will be the connectivity index of the hypothalamus to brainstem~     areas activated during migraine attacks and to the trigeminal-cervical complex.~   "
55631|NCT02328963|"~     Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after~     transplantation. It is associated with an increased incidence of acute rejection and lower~     graft and patient survivals. The goal of this study is to demonstrate that an~     immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can~     prevent acute rejection episodes as efficiently as standard regimen but also efficiently~     reduce the incidence of CMV infection at 6 months post-transplantation.~   "
55632|NCT02328950|"~     A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full~     intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation~     (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects~     and safety of FA as the backbone of a conditioning regiment for the treatment of patients~     with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic~     syndrome.~   "
55633|NCT02328937|"~     This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel~     contact lenses comparing central corneal swelling.~   "
55634|NCT02328924|"~     This study, prospective randomized controlled trial, tried to identify a cut off value of~     luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible~     gonadotropin-releasing hormone antagonist protocols.~      202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH~     antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and~     progesterone in the two study groups was measured. Total number of retrieved oocytes,~     implantation and pregnancy rate were recorded.~   "
56523|NCT02317263|"~     This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II~     clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96~     weeks duration on whole brain atrophy in men with MS.~   "
55638|NCT02328872|"~     Compass is a randomised controlled trial of primary HPV testing for cervical cancer~     screening in Australia. A pilot study involving 5,000 women was carried out in 2013-2014.~     The trial will involve recruiting 121,000 women from primary health clinics. Women aged~     25-69, attending for cervical screening or for routine follow-up will be invited to~     participate in the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from~     consenting women and sent to VCS Pathology. Women will be randomised in a 1:2 parallel group~     allocation to LBC and HPV arms using randomisation with the minimisation procedure, with~     stratification by birth cohort according to whether offered HPV vaccination in Australia's~     national publicly-funded HPV vaccination program (date of birth >=July 1st 1980 and <1st~     July 1980). In the LBC (active control) arm, women will undergo 2.5 yearly image read~     cytology screening with reflex HPV triage testing for low grade cytology. In the HPV~     (intervention) arm women will undergo 5 yearly HPV screening with partial genotyping~     enabling separate identification of HPV16 and HPV18 and referral of this group for~     diagnostic evaluation, and secondary randomisation of intermediate risk women testing~     positive for oncogenic HPV (but not HPV 16 or 18) to either image read LBC screening or~     dual-stained (DS) cytology testing with p16/Ki67. The laboratory reports issued to~     practitioners will specify the recommended management for women, according to study arm and~     test results.Participating women will be flagged on the Victorian Cervical Cytology Registry~     (VCCR) and clinical outcomes will be tracked via the VCCR. Data linkage between the VCCR and~     the National HPV Vaccination Program Register will be performed in order to integrate~     vaccination and screening histories for trial participants. Participants will be followed~     for an anticipated 5 years from the time of recruitment and the primary outcome is based on~     the total cumulative detection of CIN3+ after exit testing at 5 years.~   "
55639|NCT02328859|"~     A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and~     mobility rehabilitation in individuals with transtibial amputation. The system is composed~     of a treadmill that can simulate different environmental situations such as walking up~     stairs and hills and going around curves. The treadmill is synchronized with an immersive~     display and an avatar of the user. The combination of variable terrain and visual feedback~     is extremely promising as a means for amputee patients to achieve improved functional~     mobility after gait training. The proposed work is relevant to public health because it is~     the first step in developing a novel rehabilitation system that will use visual feedback for~     gait training in amputees and others with pathological gait disorders. The research is~     pertinent to the mission of the Department of Veterans Affairs which is committed to improve~     the quality of life of Veterans with disability.~   "
55640|NCT02328846|"~     Evaluation of the microcirculation is currently limited. Continual assessment of the tissue~     carbon dioxide-arterial carbon dioxide (PtC02-aCO2) offers a new, novel and noninvasive~     method of determining the state of the microcirculation. The investigators will apply two~     non-invasive devices, the Braedius sidesteam darkfield microscopy (SDF) microscopy device to~     the sublingual circulation and the transcutaneous PtC02 probe to the forehead in subjects~     undergoing cardiac surgery with cardiopulmonary bypass. The PtC02-aCO2 gradient will be~     determined and correlated with the videomicroscopic images of the sublingual~     microcirculation. Thereafter the incidence of postoperative organ failure and acute kidney~     injury will be determined and correlated with PtC02-arterial CO2 gradient and~     videomicroscopic images.~      Data will be analyzed by standard descriptive statistical methods.~   "
55641|NCT02328833|"~     The aim of this study is to evaluate the effects of an active multifactor implementation~     process of a Computerized Depression Guideline in Primary Care. The CPG-DEPc use use, the~     key outcomes and its maintenance over time in patients and professionals will be analyzed.~   "
55642|NCT02328820|"~     This study evaluates the prognostic value and therapeutic potential of combined pressure and~     flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary~     flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal~     medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be~     treated with percutaneous coronary intervention (PCI).~   "
55643|NCT02328807|"~     The main purpose of this study is to evaluate the safety and efficacy of focal (targeted)~     Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized~     prostate cancer.~   "
55644|NCT02328794|"~     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking~     cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to~     determine the effectiveness of 4 different interventions aimed at smoking cessation, two of~     which are incentive structures that are each grounded in behavioral economic principles. The~     other interventions will determine the effectiveness of various cessation aids, including~     electronic cigarettes and text messaging, on smoking cessation. This study will be conducted~     as an opt-out procedure where participants are automatically enrolled in the program but~     have the choice to unenroll if they so chose. This pragmatic approach will allow us to~     investigate the effects of such programs in an employee based population that can be easily~     mimicked in other employee based populations.~   "
55645|NCT02328781|"~     The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral~     artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in~     treatment of symptomatic vertebral artery stenosis.~   "
55646|NCT02328768|"~     The overall purpose of this study is to determine if replacing standard soybean oil based~     fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the~     progression of parenteral nutrition associated liver disease. It is a compassionate use~     protocol for patients who already have significant liver disease related to parenteral~     nutrition.~   "
55647|NCT02328755|"~     This protocol is an open label, single arm, non-randomized, phase I / II clinical trial~     investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for~     prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of~     allogeneic hematopoietic stem cell transplantation (HCT).~   "
55648|NCT02328742|"~     The main objective of this study is to describe the level of expression of the biological~     factors involved in the formation of adhesions (Transforming growth factor beta, Activin A,~     inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another~     intracavitary disease or no intracavitary disease.~   "
55663|NCT02328547|"~     The objectives of this study are (1) to determine the efficacy of fecal microbiota~     transplantation (FMT), given as oral capsules, compared with placebo for the treatment of~     refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact~     of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety,~     feasibility, and tolerability of FMT for patients with IBS-D.~   "
55664|NCT02328534|"~     The investigators evaluate the feedback of using swim down semen processing method during~     preparation for ICSI and compare the results of pregnancy and embryos quality with the cases~     used density gradient method for their semen processing.~   "
55649|NCT02328729|"~     Incident and extent of pulse alteration during administration of various modes of local~     anesthesia in children during routine dental treatment. Our aims are: (1) To estimate the~     percent of patients who receive mandibular block , C-CLAD-IL or infiltration injections and~     show increase in their pulse rate during the delivery of anesthesia (in spite of negative~     aspiration) as result of infiltration of adrenalin into their blood vessels. (2) To estimate~     the extent of pulse rate alteration in correlation with the velocity or volume of local~     anesthesia injected. (3) To examine the correlation between increase in the pulse rate and~     effectiveness of anesthesia. (4) To examine the correlation between the needle gauge (27 &~     30) and increase in pulse rate during mandibular block injection in spite of negative~     aspiration. We will recruit children that undergo routine dental treatment under local~     anesthesia (such as mandibular block, infiltration or C-CLAD-IL). Patients will be~     connected, immediately before and during the entire delivery of the local anesthetic, to~     pulse-oximeter that will be connected to a computer and continuously monitor pulse rate and~     saturation during the delivery of local anesthesia. Each aberrant event which may occur~     during alteration of the pulse rate such as gag reflex, coughing, or pain related disruptive~     behavior will be documented on the computer in real time by another person that is not the~     treating dentist. All types of local anesthesia delivery will be performed by the~     computerized-controlled local anesthesia delivery system - Single-Tooth-Anesthesia which~     connected to a computer and documents continuously the amount and velocity of the local~     anesthetic delivered to the patient. All injections will be performed by using a 29 gauge~     needle, except when children will be treated under general anesthesia, the injection will be~     performed also by 27 gauge needle. In case the pulse rate will increase to 150% of the~     baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped~     immediately. The continuation of the local anesthetic delivery will be continued in~     different location and only after the return of the pulse to its basic rate. A total of 100~     patients will receive local anesthetic containing 1:100,000 adrenalin and 50 patients~     without adrenaline. Three modes of local anesthesia will be evaluated: C-CLAD-IL,~     infiltration and mandibular block= a total of 300 patients.~   "
55650|NCT02328716|"~     The purpose of this clinical trial is to Investigate whether the administration of HIPEC~     with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction~     in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival~     period compared with patients without HIPEC treatment.~   "
55651|NCT02328703|"~     This is a prospective, randomized, double-blind, placebo-controlled, repeated measures study~     with intention-to-treat that involves exposure to Reiki therapy or a placebo control~     intervention for a total of six treatments, three treatments per week for two weeks, with a~     2-week follow-up for the decrease of neuropathic pain in extremity trauma.~   "
55652|NCT02328690|"~     The purpose of this prospective, double-blind, repeated measures study is to assess the~     efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular~     measures as well as to assess the feasibility of implementing a BBT intervention in a~     military population during the high risk post-deployment window.~   "
55653|NCT02328677|"~     ColoCare is an international prospective cohort study of stage I-IV colorectal cancer~     patients (ICD-10 C18-C20).~   "
55654|NCT02328664|"~     After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma,~     pathology usually can not guarantee a radical resection from an oncological point of view.~     In such case, additional surgical resection is advised. However, only in 15% of patients,~     residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from~     the polypectomy scar for residual adenocarcinoma.~   "
55655|NCT02328651|"~     This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer~     Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth~     disease compared with the controlgroup that recieve only libavirin treatment.~   "
55656|NCT02328638|"~     The purpose of the proposed study is to develop and pilot test a manual-based,~     interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder~     (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit,~     and Expanding variety (CHANGE) obesity program.~   "
55657|NCT02328625|"~     This registry study will assess the safety and performance of the Celution Device in the~     processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs)~     in the treatment of hand scleroderma.~   "
55658|NCT02328612|"~     Phase I, randomized, parallel group, placebo control, unicentric, interventional study.~     Thirty two healthy male volunteers aged between 18-35 years will be randomized into the~     eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.~      The treatment administration will be infused intravenously to the following groups after~     randomization:~        -  First arm: 250,000 cells/kg~        -  Second arm: 1 million cells/kg~        -  Third arm: 4 million cells/kg~        -  Fourth arm: placebo according to their weight.~      An hour after the end of the eASCs administration, all subjects will be given an intravenous~     dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable~     by the investigator.~   "
55659|NCT02328599|"~     Previously, 4 investigators conducted randomized controlled trials (RCT) at their own site~     to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management~     of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years.~      The aim of this study is to combine data from the 4 studies and continue to follow the~     original randomized subjects for an additional 2 years of follow-up. The purpose of the~     study is to determine the longer term durability and effectiveness of bariatric surgery~     compared to medical/lifestyle intervention on the treatment of type 2 diabetes.~   "
55660|NCT02328586|"~     This research project will test the feasibility and effectiveness of group acupuncture for~     the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or~     osteoarthritis).~   "
55661|NCT02328573|"~     The study will focus on the impact of communal singing on patients with stroke and their~     personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the~     first group of 20 stroke survivors and their caregivers (up to 40 total participants) will~     receive 6 months (approximately 24 sessions) of music therapy. The second control groups of~     20 stroke survivors and their caregivers will receive standard post-stroke care~   "
55662|NCT02328560|"~     The project aims primarily to measure the expected paramedic consultation announcement~     benefits for the patient, at different levels. It will measure improvements in the~     management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims~     to provide a better understanding of the disease and treatment incurred, which should lead~     to the implementation of joint strategies between the healthcare team and the patient to~     prevent the effects of and treatment of the disease by the patient and caregivers.~      This improvement is to promote the fair treatment by reducing patient anxiety and / or~     carers and involving them in the management of their disease. In this context, it is shown a~     profit of paramedical consultation for the patient, it will work, based on the~     recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad~     consultation.~      This work should also help measure the impact of ad paramedical consultation on optimizing~     care consumption off-line therapy and to assess the associated costs.~      For patients who received paramedic ad or not consultation, it will therefore be of~     particular compare intercurrent hospitalizations, commuting structure of care, the number of~     consultations with the doctor, the reports of cure, additional biological monitoring or~     other health care consumption.~      With the participation of several centers in the fight against cancer, this study will~     provide valuable information on the practice of paramedical consultation ad in several tumor~     sites.~      It will objectify the benefit provided by the Medical device announcement for both patients~     and the organization and use of care prerequisite to encourage better integration of this~     device in the course of patient care, the consultation paramedical ad remaining poorly~     understood by many health professionals.~   "
55669|NCT02328469|"~     The main objective of this study is:~        -  to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia~        -  to assess the clinical course and outcome of tick-borne encephalitis and Lyme~          neuroborreliosis~        -  to characterize the inflammatory proteins, gene polymorphisms, and transcriptome~          profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis~   "
55670|NCT02328456|"~     The purpose of the study is to use a randomized controlled design to determine the impact of~     a SMS messaging associated with free eye drops intervention on the following outcomes among~     patients after trabeculectomy surgery in rural China.~   "
55671|NCT02328443|"~     Evaluation and validation of metabolic markers for the assessment of CYP3A activity and~     prediction of drug-drug interaction in Korean healthy subjects.~   "
55672|NCT02328430|"~     Comparison of standard spirometry to non invasive remote lung function measures of chest~     wall movement using depth camera technology.~   "
55673|NCT02328417|"~     Prospective non randomized study of two cohorts: usual protocol and the application of~     accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to~     protocol of each center. Compliance to be assessed.~   "
55674|NCT02328404|"~     This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial~     designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on~     Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level,~     serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight~     Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.~   "
55675|NCT02328391|"~     OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in~     second-line treatment in patients with lung cancer advanced non-small of histology~     predominantly flaky by assessing the survival free of progression (SLP).~      Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP)~     type.~      DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to~     study the drug under study is erlotinib.~      -Dose and treatment guidelines follow the corresponding product sheet. Management of dosage~     and adverse effects specified in point H. 15 of the Protocol.~      POPULATION in study and number TOTAL of subjects population under study: adult patients with~     diagnosis of NSCLC with predominantly squamous histology total number of subjects: the~     participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non~     Small Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is~     erlotinib.~      -Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage~     and adverse effects specified in point H. 15 of the Protocol.~      STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC~     with predominantly squamous histology total number of subjects: the participation of~     approximately 51 patients is expected.~   "
55676|NCT02328378|"~     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage~     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local~     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread~     of the local anesthetic agents produces extensive analgesia and prolonged action of the~     injected local anesthetic solution.~      Previous studies showed that TAP block may not be effective in improving postoperative~     analgesia in patients who had cesarean section under spinal anaesthesia.~      The aim of this randomised controlled, double blinded study is to examine the effect of QLB~     on the postoperative pain management in patients who had cesarean section under spinal~     anesthesia.~   "
55677|NCT02328365|"~     More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as~     heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment~     owing to increased mortality within the first weeks to months after surgery. Since the~     operation itself constitutes a severe challenge to the patient's cardiopulmonary system,~     this study aims to elucidate whether a more systematic perioperative management and~     follow-up of colorectal cancer patients with cardiopulmonary comorbidity may improve their~     outcome as measured by complications, hospitalisation times, and survival.~   "
55678|NCT02328352|"~     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new~     fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans,~     in laparotomic procedures and as a new device for the treatment of solid cancer and~     hematopoietic system tumors.~      The experimentation on this new material, preliminary conducted on breed female rabbit New~     Zeeland, will be applicable to human, if the results in terms of toxicity and durability~     will be comfortable.~   "
55679|NCT02328339|"~     The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar~     a placebo matched for taste and appearance in a blinded cross over design.~   "
55680|NCT02328326|"~     This trial will compare two methods of increasing engagement in care and success in diabetes~     management, among patients with diabetes with high-risk features, who also have family~     members involved in their care.~   "
55681|NCT02328313|"~     To determine if exercise will affect the increase in p16 expression that is associated with~     both chemotherapy administration and advancing age.~   "
55682|NCT02328300|"~     This is a single arm, single center study of 15 patients with brain lesions being treated at~     UNC Hospitals. Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled~     surgical biopsy of their brain lesion(s).~   "
55683|NCT02328287|"~     Failed fusion and failure to relieve back pain following spinal fusion are still frequent,~     irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision~     surgeries are unfortunately associated with higher procedure-related complication rates,~     technical difficulties, longer operative time, and quite disappointing and unreliable~     success rates for both fusion and clinical results.~      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.~   "
55705|NCT02328001|"~     This study performs a single intervention of informing endoscopists how much the disposable~     accessories cost following each procedure. Following this single and simple intervention,~     prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will~     be compared to the same resource costs during a control period where endoscopists are~     blinded to their observation.~   "
95112|NCT01812174|"~     This study examines the hemodynamic and hemolytic properties of two additional smaller size~     valves to the On-X line of valves already approved by FDA.~   "
55684|NCT02328274|"~     Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its~     popularity in the past decade due to its minimal invasiveness that results in less operation~     time, less blood loss and quicker return to normal activity. The standard surgical procedure~     in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus,~     dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed~     by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel,~     monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer~     operative time and higher possibility of conversion to laparotomy due to technical~     difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a~     modified surgical technique of LASH which incorporated two methods of vessels ligation and~     laparoscopic in situ morcellation.~   "
55685|NCT02328261|"~     This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with~     advanced nasopharyngeal carcinoma.~   "
55686|NCT02328248|"~     The purpose of this study is to observe the effective and safety in the laparoscopic repair~     of hiatal hernia using biological patch versus plastic.~   "
55687|NCT02328235|"~     Skeletal muscle burns a significant amount of the fat and sugar that circulates in the blood~     stream. Ideally, when sugar is elevated in the blood stream, the muscle will either use it~     to make new energy or store it for later use. Likewise, for fatty acids. Skeletal muscle of~     obese and diabetic humans has been shown to inadequately use either sugar or fatty acids~     when they increase in the blood stream, and this has been termed metabolic inflexibility.~     The cause of metabolic inflexibility is not known, but it is believed that eating more fat~     than the body needs for energy may be a contributing factor. Metabolic inflexibility in~     skeletal muscle is bad because if the muscle does not use the sugar or fat, it will be~     stored elsewhere in the body and potentially lead to obesity and the resistance to insulin.~     The investigators have performed a research study with nonobese, healthy humans during which~     we fed them a high fat diet for 5 days. Interesting, only 5 days of a high fat diet is~     sufficient to cause the skeletal muscle to become metabolically inflexible just like that~     observed in obese and diabetic humans. The investigators are proposing addition studies to~     feed healthy humans a high fat diet for 5 days in effort to better understand what causes~     metabolic flexibility. The investigators are speculating that a high fat diet causes the~     intestines to release a substance called endotoxin that causes muscle to become~     metabolically inflexible. The investigators will test this notion in our proposed studies.~   "
55688|NCT02328222|"~     BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve~     long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that~     alter graft function or survival. Our objective was to evaluate the effects of early steroid~     withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme~     consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction~     treatment with basiliximab.~      METHODS: A randomized clinical trial was performed on first renal transplant recipients. In~     the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth~     day post-transplantation. In the Control group, patients continued steroid treatment.~   "
55689|NCT02328209|"~     Recently studies have shown that intravitreal injection of ranibizumab is effective for age~     related macular degeneration. However there are problems about injection regimen of~     maintenance phase. We plan to perform new simplified treat and extend regimen using~     ranibizumab.~   "
55690|NCT02328196|"~     The McGill Ingestive Skills Assessment (MISA) for measuring dysphagic clients' functional~     performance during meals has been previously translated into Danish (MISA-DK) and this~     translated version validated. Critical issues about the construct validity of the scale, per~     se, had been raised. Consequently, major revisions of the MISA-DK have been undertaken,~     which necessitates a new validation process. Therefore, the purpose of this study is to~     evaluate the construct validity of a revised version of the MISA-DK when used amongst~     dysphagic adults in hospitals settings and community services.~   "
55691|NCT02328183|"~     The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram~     negative bacterial infection. The hypothesis of study is Polymyxin B would be the new~     antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes~     and minimal side effects.~   "
55692|NCT02328170|"~     The purpose of this study is to determine the correlation of specific IgE levels to common~     foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap~   "
55693|NCT02328157|"~     Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative~     corneal astigmatism.~      Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival~     sutureless vitrectomy, resulting in good visual recovery. So far, however, limited~     information is available on the the stability of axis rotation, astigmatism correction, and~     improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a~     25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the~     current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a~     triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount~     of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and~     corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show~     that postoperative IOL axis stability is similar to that reported for cataract surgery alone~     in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.~   "
55694|NCT02328144|"~     Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause~     of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a~     difficult symptom to appreciate and assess, by its frequent and large variations in~     sensitivity in each patient. Many studies have been done to reduce patient postoperative~     pain, but there is no ideal method. The application of both oral and topical metronidazole~     has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.~      The investigators evaluated the effect of oral administration of metronidazole versus~     homologated placebo in pain control after hemorrhoidectomy~   "
55724|NCT02327754|"~     The purpose of this study is to investigate the effect of topiroxostat on urinary albumin~     excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia~     with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40)~     for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO.,~     LTD.~   "
55695|NCT02328131|"~     The great diversity of regimens and treatment lines, the different efficacy of these, mostly~     due to the increase in bacterial antibiotic resistance and regional differences, requires a~     continuous critical analysis of clinical practice, evaluating systematically the efficacy~     and safety of the different regimens and the cost-effectiveness of the different~     diagnostic-therapeutic strategies. This will help in the design of an efficient and~     optimized treatment that will reduce number of re-treatments, diagnostic tests and the~     appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and,~     probably, gastric cancers. Therefore, the evaluation of real clinical practice using~     non-interventionist registries will help to improve the design and organization of European~     Consensus on the management of H. pylori infection, which is the best way to establish~     healthcare efficiency.~      Primary aim~      To obtain a database registering systematically over a year a large and representative~     sample of routine clinical practice of European gastroenterologists in order to produce~     descriptive studies of the management of H. pylori infection.~      Secondary aims~        1. To evaluate H. pylori infection consensus and clinical guidelines implementation in~          different countries.~        2. To perform studies focused on epidemiology, efficacy and safety of the commonly used~          treatments to eradicate H. pylori.~        3. To evaluate accessibility to healthcare technologies and drugs used in the management~          of H. pylori infection.~        4. To allow the development of partial and specific analysis by the participating~          researchers after approval by the Registry's Scientific Committee~      Methodology Non-interventionist prospective multicentre international registry promoted by~     the European Helicobacter Study Group. A renowned gastroenterologist from each country was~     selected as Local Coordinator (30 countries). They will in turn select up to ten~     gastroenterologists per country that will register the routine clinical practice~     consultations they receive over 10 years in an electronic Case Report Form (e-CRF).~     Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation~     and outcome data. The database will allow researchers to perform specific subanalysis after~     approval by the Scientific Committee of the study.~   "
55696|NCT02328118|"~     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic~     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth~     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.~   "
55697|NCT02328105|"~     ABRAXANE, based on results from prior studies, is a promising drug in squamous cell~     carcinoma of the lung. This study will help to explore the combination of ABRAXANE and~     carboplatin more thoroughly in the subgroup of patients who had the best response in prior~     studies as well as determine whether there are any biomarkers which can predict for~     response.~   "
55698|NCT02328092|"~     The purpose of this study is to assess the efficacy of daily sacral root magnetic~     stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were~     randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS;~     15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before~     starting treatment, immediately after the 5th and 10th treatment session, and 1 month later,~     using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical~     excitability of upper and lower limbs were done before and after the end of sessions.~   "
55699|NCT02328079|"~     The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in~     complete recovery of facial Palsy. Fifty patients (Males and females) with acute Facial~     Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient~     submitted to the following clinical evaluation using House and Brackmann6 facial function~     scoring system and Synnybrook grading system neurophysiological assessment of facial nerve~     and muscles before and after the end of treatment and then after the end of first and second~     month of treatment. EMG will be done for facial muscles of both sides beside measuring~     facial nerve excitability to determine the excitation threshold by recording the minimum~     electrical stimulus required to produce visible muscle contraction. A difference greater~     than 3.5 mA between the affected and unaffected side is considered to be significant in~     terms of poor prognosis. Nerve conduction study of facial nerves of both sides using~     concentric needle electrode. Trigeminal Blink reflex for both side of the face. Facial~     functional recovery was defined as good or complete using the same criteria used in the~     2001 practice guideline. Using the House and Brackmann6 facial function scoring system, we~     considered an outcome of grade I or II a good recovery.~   "
55700|NCT02328066|"~     The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to~     predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold~     standard, in a group of endoscopists who previously performed a training program.~   "
55701|NCT02328053|"~     The study is a randomised control trial to assess the visual and clinical outcomes of~     collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal~     blindness in India and the therapeutic options available are minimal to handle the advanced~     complications and sequalae caused by the disease.The antimicrobial and tissue remodeling~     role of corneal cross linking was demonstrated by several studies earlier,we anted to~     specifically assess the role of corneal cross linking in non resolving fungal keratitis in~     prevention of perforation and enhancement of healing process.~   "
55702|NCT02328040|"~     There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (Type 1 DM),~     however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia)~     which is FDA approved to treat people with type 2 diabetes which helps correct their glucose~     (sugars) after meals. This study is going to test whether this drug can improve the after~     meal sugars in people with type 1 diabetes. To test this, you will be given a mixed meal and~     its effects on insulin levels. The hormones that affect blood glucose as well as your sugar~     levels will be measured by a series of blood tests. We will also look for high blood sugars~     which might occur because of food staying longer in the stomach than usual or due to the~     suppression of a hormone called glucagon which increases blood sugar. If you qualify, you~     will be given sitagliptin (Januvia) 50 mg and 100 mg dosages. You and the researchers will~     not know which dose you are taking at any single visit. We will first enroll 10 subjects~     with established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30~     years old. The first 10 patients will be evaluated for safety parameters such as ability to~     keep blood sugars < 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia~     (low blood sugars) and so on. After this safety criteria is established, we will then~     recruit subjects between the ages of 14-19 yrs for the next phase of the study. A total of~     17 subjects will be enrolled into the study.~   "
55703|NCT02328027|"~     The objectives of the study are:~      Primary objective:~      - To determine the safety and tolerability of medical imaging with 99mTc-rhAnnexin V-128~      Secondary objectives:~        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of~          99mTc-rhAnnexin V-128~        -  To demonstrate the time-dependant distribution and localization of 99mTc-rhAnnexin~          V-128 both in RA and AS patients~        -  To determine ability of early imaging with 99mTc-rhAnnexin V-128 to evaluate the~          presence of lesions before and after short term treatment of either RA or AS patients.~      Study hypothesis:~      99mTc-rhAnnexin V-128 could be used as an adjunct for the diagnosis of early stage~     rheumatoid arthritis and ankylosing spondylitis and for the assessment of response to~     treatment of these diseases.~   "
55706|NCT02327988|"~     This study propose investigate the effect of cryotherapy and laser therapy in response to~     strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms).~     All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions~     of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the~     exercise), composed of pain sensation, measure of the strength and muscle activation.~   "
55707|NCT02327975|"~     Physical inactivity is a health problem that affects people worldwide and has been~     identified as the fourth largest risk factor for overall mortality (contributing to 6% of~     deaths globally). Many researchers have tried to increase physical activity (PA) levels~     through traditional methods without much success. Thus, many researchers are turning to~     mobile technology as an emerging method for changing health behaviours.The study consists of~     a physical activity intervention through a mobile application in elderly. The study is a 3x2~     model, in which the sample is distributed in three study groups (over 53 years) and were~     evaluated at 10 weeks from baseline.~   "
55708|NCT02327962|"~     Chronic kidney disease (CKD) accelerates vascular stiffening related to age. Arterial~     stiffness may be evaluated measuring the carotid-femoral pulse wave velocity (PWV) or more~     simply, as recommend by KDOQI, monitoring pulse pressure (PP). Both correlate to survival~     and incidence of cardiovascular disease. PWV can also be estimated on the brachial artery~     using a Mobil-O-Graph; a non-operator dependent automatic device. The aim was to analyse~     whether, in a dialysis population, PWV obtained by Mobil-O-Graph (MogPWV) is more sensitive~     for vascular aging than PP.~      A cohort of 143 patients from 4 dialysis units has been followed measuring MogPWV and PP~     every 3 to 6 months and compared to a control group of non-CKD patients.~   "
55709|NCT02327949|"~     The purpose of this study is to determine whether this new W-Shaped Angular Plate is more~     effective and more safe to operate than the traditional reconstruction plate in the~     treatment of the posterior wall fracture of acetabulum.~   "
55710|NCT02327936|"~     The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL~     and to compare their efficacy for overactive bladder syndrome in children.~   "
55711|NCT02327923|"~     Comparison of intraoperative infusion of lidocaine and esmolol in the postoperative~     requirement of opioid for postoperative pain management after laparoscopic cholecystectomy~     to decrease opioid related side effects and enhance postoperative recovery with multimodal~     analgesia approach.~   "
55712|NCT02327910|"~     Three hundred aged(age>65y) patients were randomized to Commom group(C group). Qualitative~     TOF monitoring (TOF group). Qualitative TOF and transcutaneous partial pressure of carbon~     dioxide monitoring(Unite group). Anesthetic management was standardized in all subjects .The~     patients of C group were extubated when standard criteria were met; T group patients had a~     TOF ratio of greater than 0.90 as an additional extubation criterion;and U group patiens~     were extubated when TOF ratio is greater than 0.90 and meanwhile transcutaneous partial~     pressure of carbon dioxide recovered to preoperative ±5mmHg .All the patients were transport~     to the PACU after extubation.Compare the adverse respiratory events at the moment of~     extubation, on the arrival of PACU, at 30min and 60min moment in the PACU respectively.~   "
55713|NCT02327897|"~     Background:~      - Asthma is a serious clinical and public health problem. Researchers want to collect data~     to better understand how bacteria and other things in the environment can affect people's~     asthma.~      Eligibility:~      - Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or~     breastfeeding.~      Design:~        -  Partaicipants will complete a medical history form before the first visit.~        -  Study visits will include collecting medical history, and conducting physical exam,~          lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and~          sputum samples.~        -  Participants will take tests that measure their breathing abilities. They will give~          saliva samples for DNA study. They will get kits to collect stool and dust samples at~          home. They will fill out surveys.~        -  Participants will have visits every 6 months for 5 years. They can schedule sick~          visits, if needed, at no cost to the participant. For all visits, they will have asthma~          check-ups and get treatment, at no cost to the participant.~        -  Some participants may take part in a sub-study that includes one 4-hour visit. They~          will have medical history, physical exam, and lung tests. They will have urine tests to~          check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this,~          an intravenous line will be placed in an arm vein. The nose and throat will be numbed.~          A flexible fiber-optic tube will be inserted into their airways through the nose. Their~          airways will be examined and areas of their lung will be washed. A small sample of~          cells will be taken.~   "
55714|NCT02327884|"~     Background:~      - Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders~     can affect a person s quality of life. Studying people who have a disease that affects their~     salivary gland(s) may teach researchers about the disorders and their genetics.~      Objectives:~      - To study salivary gland diseases and disorders. To collect data and samples from people~     with salivary gland problems and their relatives.~      Eligibility:~        -  People more than 4 years old who have or are suspected to have a disease involving~          salivary glands.~        -  Their relatives more than 4 years old.~        -  Healthy volunteers 18 years or older.~      Design:~        -  Participants may be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  General oral and dental history and exam~        -  Saliva collection~        -  Eye exam and test for dry eyes~        -  Health questionnaires (adults)~        -  Biopsy of some minor salivary glands. A small incision will be made on the inside of~          the lower lip and several tiny salivary glands will be removed.~        -  Participants will have 2 3 visits. These may include:~        -  Repeats of some screening tests~        -  Ultrasounds of some glands. Researchers will put some gel on the face, then press on it~          with a smooth wand.~        -  Adults may have other biopsies~        -  A small catheter inserted into the opening of the parotid gland duct on the inside of~          the cheek. A saline solution (in a syringe) will fill the duct.~        -  Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup~        -  Scrapings collected from teeth, tongue, and cheeks~   "
55725|NCT02327741|"~     1010 patients post stenting were enrolled to receive Plavix more than 12 months and less~     than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE)~     were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.~   "
55715|NCT02327871|"~     To control patient's body temperature remains of major importance especially after cardiac~     arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most~     unconscious CA patients. However, available modalities for inducing TH have a number of~     technical (side effects), logistical (difficulties of placement), and financial (cost)~     barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger~     placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a~     device that potentially improves the effectiveness of TH in minimizing the risks of existing~     methods (such as invasive cooling). Initial mathematical and animal studies have shown~     strong support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is~     a systematic standard of care for all unconscious patients suffering from CA. The present~     study will replace the usual naso-gastric probe by the ECD that can be used for gastric~     suctioning as usually done in such patients.~      The aim of this prospective, interventional study is to assess the feasibility and safety of~     the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary~     outcome is the feasibility of inducing, maintaining, and rewarming patients from TH using~     the ECD (cooling rate, rewarming rate, and the percent of time within goal temperature~     during the goal-temperature maintenance period). Evaluation of adverse events (including~     cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia,~     odynophagia, aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury,~     and esophagitis) will be closely monitored during the whole period of the targeted~     temperature management (secondary endpoint).~   "
55716|NCT02327858|"~     According to the World Health Organisation, depression and problem drinking are among the~     leading causes of disability worldwide. Most patients who present with problem drinking~     and/or depression have poor quality of life and pose a great economic burden to society due~     to their higher use of health services. We seek to develop a new, enhanced, efficient,~     innovative and cost effective treatment strategy aimed at reducing the burden that these two~     mental conditions impose on sufferers, their families as well as the community and health~     systems. In a recent pilot study of supportive text messages in Ireland conducted by the~     Principal Applicant and a team of researchers for patients with problem drinking and~     co-occurring depression, we established that patients who received twice daily supportive~     text messages for three months had significantly less depressive symptoms than those who did~     not receive such messages. There was also a trend that patients who received the supportive~     text messages were more likely to have higher alcohol free days than those who did not~     receive any supportive text messages.Our study was limited by the small number of~     participants and it did not examine the impact of the text messages on health services~     utilization. Our study did not also examine the effects of supportive text messages on those~     with only depression or only problem drinking. The proposed study seeks to extend the~     knowledge gained from the pilot study in Ireland by examining the impact of supportive text~     messages in the individual disorders~   "
55717|NCT02327845|"~     The goals of this study are: (1) to better understand the relationship between the phenotype~     and genotype of amyotrophic lateral sclerosis (ALS) and related diseases, including primary~     lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy~     (PMA), and frontotemporal dementia (FTD); and (2) to develop biomarkers that might be useful~     in aiding therapy development for this group of disorders.~   "
55718|NCT02327832|"~     Patients eligible for this study include those with decompensated liver cirrhosis with a~     Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical~     treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total~     bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are~     still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous~     bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin~     was added after collection. In addition, at the Center for Regenerative and Cell Therapy at~     Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell~     suspension was prepared by adding culture medium, and this was inoculated into a culture~     flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The~     primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.~   "
55719|NCT02327819|"~     Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect~     of BCAA on existing liver cancer is unknown.~      The participants (post curative intent surgery) will be supplemented with either~     BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until~     a new liver tumor is found.~   "
55720|NCT02327806|"~     Pulsed electromagnetic field therapy (PEMFT) is a reparative technique most commonly used in~     the field of orthopedics for the treatment of non-union fractures. The aim is to test the~     effect of the magnetic induction on brute force of treated muscle in oncological patients.~     Oncology patients were chosen as we assume that the ipmrovement will be more noticable in~     oncology patients than in a non-oncology, healthy subjects.~   "
55721|NCT02327793|"~     The purpose of this study is to provide a description of blood flow changes in the brain~     after blood pressure lowering drugs are given. This information will be used by physicians~     to guide blood pressure lowering therapy in stroke patients in the future.~   "
55722|NCT02327780|"~     Treatment of IBS is very problematic. Despite the wide range of pharmacological and~     non-pharmacological therapies, there is no universally accepted approach. In recent years,~     the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms~     of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols)~     are a group of dietary sugars that may be poorly absorbed in the small intestine and~     fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in~     fluid content in the colon and trigger functional gut symptoms in some individuals. This~     study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms~     of IBS compared to the standard dietary advice.~   "
55723|NCT02327767|"~     The goal of this project is to test a device (Zondervan et al, 2013) that can provide active~     assistance for arm training for people in Vietnam with severe to moderate stroke, but that~     is also simple and does not rely on powered actuators. The hypothesis is that individuals~     with a severe chronic stroke, who exercise with a mechanically passive rehabilitation~     device, will have improved arm movement ability without experiencing an increase in arm~     pain.~   "
55732|NCT02327650|"~     Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we~     and others have previously reported, a portion of OA might be caused primarily by bone~     alterations. In this study, we prospectively and retrospectively show that the bone~     altertations may affect OA primarily in all of the joints.~      In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks~     synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The~     etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone,~     instead of cartilage. Here we prospectively and retrospectively show that the bone~     altertations may affect RA primarily in all of the joints.~   "
55733|NCT02327637|"~     Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the~     lack of data to support its benefits, and increasing evidence pointing to potential harms.~     In this study, the effects of bed rest compared to moderate activity will be on maternal~     mood and muscle strength will be evaluated in patients with preterm premature rupture of~     membranes (PPROM).~   "
55734|NCT02327624|"~     The principal hypothesis of this study is that two different maintenance regimens of~     ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte~     adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous~     Coronary Intervention (PCI) for stable Coronary artery disease (CAD).~   "
55735|NCT02327611|"~     Postoperative renal failure is the most significant risk factor for early mortality after~     elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).~      To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair,~     the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since~     the most studied crystalloid solution is the Ringer's lactate solution, this can be~     considered the standard of care for evaluating the effectiveness of other substrates.~      An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr.~     Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during~     transplantation and for cardioplegia during open-heart surgery in most EU countries. This~     solution may provide a better grade of renal protection to ischemic damage than the standard~     crystalloid solutions.~      A recent observational study published by our group suggested a lower incidence of~     postoperative renal kidney injury in patients undergoing open TAAA surgical repair using~     renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's~     lactate solution.~      Objective of this study is the confirmation of the promising findings about the~     effectiveness of renal perfusion with Custodiol during repair of TAAA compared with other~     crystalloid.~      The study will be a prospective, single-center, randomized, double-blind, controlled trial,~     investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol~     renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult~     patients undergoing elective TAAA open repair. Participants will be followed for the~     duration of hospital stay, an expected average of 2 weeks.~   "
55736|NCT02327585|"~     ADHD children have executive function (EF) impairments,so we randomize the children to the~     training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether~     EF deficits are amenable to the training in children with ADHD.~   "
55737|NCT02327572|"~     This research project aims to study this intriguing relationship between ageing and breast~     cancer biology, and more specifically the changes that occur within the tumor~     microenvironment with increasing age. Furthermore, it will focus on the link between these~     microenvironmental changes and organismal ageing (as measured by chronological age,~     geriatric evaluation of elderly patients, and circulating biomarkers of ageing), since it~     seems logical that age-related changes in the stromal part of a tumor (fibroblasts, immune~     cells, endothelial cells, fatty cells, …i.e. host cells) are due to the ageing process of~     the entire body. Most particularly, the amount and type of infiltrating immune cells might~     reflect the degree of immunosenescence of the host. More and more research points out the~     crucial role of the immune system in tumorigenesis and progression, and, at the same time,~     the immune system is one of the most affected components in the process of ageing. .~   "
55738|NCT02327559|"~     The purpose of this small randomized controlled trial (RCT) is to compare the impact of a~     brief (16 hour) 3rd trimester mindfulness-based childbirth education program, Mind in Labor~     (MIL): Working with Pain in Childbirth, with a standard care/treatment as usual (TAU)~     active control condition of standard hospital- and community-based childbirth education. The~     MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing~     and greater childbirth self-efficacy), less perceived pain in labor, less use of pain~     medication in labor, greater birth satisfaction, and better prenatal and postpartum~     psychological adjustment compared to the TAU group.~   "
55739|NCT02327546|"~     The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548~     with ferrous sulfate relative to AKB-6548 in healthy volunteers.~   "
55740|NCT02327533|"~     In this study, the investigators evaluated molecular biomarkers which play a role in the~     development of generalized aggressive periodontitis (GAgP) using gingival tissue samples~     through omics-based whole-genome transcriptomic while using healthy individuals as~     background controls.~   "
55741|NCT02327520|"~     The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand~     Nationwide Hospital Admission Database, which is part of the National Health Security Office~     (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes,~     either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The~     inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile~     (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was~     excluded. The baseline characteristics, including age, sex, co-morbidity disease and history~     of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of~     hospital stay (LOS), mortality rate, and hospital charge.~   "
55842|NCT02326181|"~     The study will investigate the effects of different training types ,including combined~     inspiratory with expiratory pressure threshold training,inspiratory pressure threshold~     training on patients with chronic obstructive airway disease and investigate whether~     expiratory pressure threshold training associated with inspiratory pressure threshold~     training would be better than inspiratory pressure threshold training alone, with regard to~     exercise capacity, respiratory muscle strength and endurance.~   "
55742|NCT02327507|"~     Dental caries (tooth decay) is a disease with significant public health implications~     afflicting low-income children, with marked rural disparities in disease prevalence and~     treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties~     have experienced tooth decay. Effective approaches to prevent decay include brushing with~     fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally~     entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet~     <50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with~     parental education can increase toothbrushing frequency and reducing tooth decay. However,~     many parents are confused about when to start, how much and often toothpaste should be used,~     and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older~     children to brush their own. The investigators' objective is to implement and evaluate a~     community-wide toothpaste distribution campaign enhanced by telephone support for OHP~     children and adolescents and their families in Central Oregon~   "
55743|NCT02327494|"~     Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore~     hemodynamics. However, no studies has been performed comparing oxygenation parameters during~     laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade.~      The investigators aim to investigate whether the intense neuromuscular blockade produces a~     better oxygenation profile measured by the central venous oxygen saturation than the~     moderate neuromuscular blockade.~      This is a one centre, prospective clinical trial to compare oxygenation data at different~     stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery.~     Data recording will be blinded to the anesthesiologist in charge of the patient, who will~     manage patients by a determined protocol, based on stroke volume data to direct~     fluidotherapy. Data analyzer will be not be involved in the study design or in writing~     reports from the study. Inclusion criteria: Be a candidate to a colorectal surgical~     resection procedure and one of these conditions: ≥ 70 y.o, or respiratory co-morbidity, or~     cardiac co-morbidity or haemoglobin level < 11g/dl. The primary outcome is the absolute~     number of the central venous oxygen saturation, measured at the following points: basal,~     after tracheal intubation, before pneumoperitoneum or abdominal incision, after~     pneumoperitoneum or abdominal incision, 5 and 10 minutes before administration of rocuronio~     to produce intense blockade, continuously during profound neuromuscular blockade until the~     end of surgery, before sugammadex administration, after sugammadex administration, after~     tracheal extubation, for the 24 hours post surgical. Data of the regional cerebral oxygen~     saturation will be measured at the same points.~      The investigators hypothesize that oxygenation data will be favourable by applying the~     intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the~     investigators hypothesize that oxygenation data obtained during the whole procedure~     including the first 24-hours post-surgery, measured by the regional cerebral oxygen~     saturation are comparable to data obtained by the central venous oxygen saturation. The~     investigators want to obtain information about influence in the outcome of producing~     profound neuromuscular blockade during laparoscopy colorectal by comparison of outcome data~     with matched historical control.~   "
55744|NCT02327481|"~     The purpose of this study is to explore the feasibility of 3D Laparoscopic Surgery for~     Gastric Cancer.~   "
55745|NCT02327455|"~     The specific aim of this clinical trial is to translate the investigators new 4DE (three~     sptial dimensions pluse time) stress echocardiographic method to patients with coronary~     artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the~     reproducibility of the technique in this clinical setting.~   "
55746|NCT02327442|"~     The purpose of this study is to assess the safety, biodistribution, dosimetric properties of~     the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To~     preliminarily evaluate its application in glioma diagnosis.~      To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant~     chemotherapy in patients with breast cancer before and after the therapy.~   "
55747|NCT02327429|"~     In Canada, there is a fast-growing population with diabetes, and the majority of diabetes~     cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular~     diseases, eye disease and foot disease, impair the quality of life and life expectancy.~      Chinese are the second largest visible minority in Canada. The diabetes incidence increased~     much more rapidly in the Canadian population of Chinese origin compared with that of~     European origin in past decades. Cultural factors are very likely to affect individual~     behaviour in diabetes treatment. Both international and Canadian diabetes organizations have~     recognized the importance of taking into account the cultural background and individual~     preferences in diabetes treatment.~      However, there lacks cultural relevant nutritional recommendations or guidelines for Chinese~     Canadians except some literally translated materials which may not be culturally relevant.~     In order to fill the gap, the investigators have developed a Chinese menu plan that includes~     commonly consumed Chinese dishes with nutrients breakdown and cooking tips to provide~     guidance for patients in their daily meal planning. This menu plan is a cultural translation~     of the Canadian nutritional guidelines, which is urgently needed among Chinese immigrants~     with T2D in Edmonton, according to our previous needs assessment.~      In this pilot test, the investigators will examine the feasibility and effectiveness of the~     Chinese menu plan. Twenty Chinese with T2D in Edmonton will be recruited to use the menu~     plan for 3 consecutive months and relevant indices of T2D will be tested as indicators of~     effectiveness. Feedback from participants will be obtained through one-on-one interviews and~     appropriate modifications will be made to the menu plan.~   "
55748|NCT02327416|"~     This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial~     to assess the efficacy and safety of combination and sequential treatment with Y~     peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or~     nucleosides experienced. Patients were randomized to one of 3 groups to receive different~     antiviral treatment.~   "
55749|NCT02327403|"~     Background: Proteinuria develops in about 30% of kidney transplant recipients and is a~     strong predictor of graft loss. The amount of proteinuria has a direct correlation with the~     risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent~     graft loss in transplant recipients, since ACE inhibitors carry a number of limitations in~     the transplant setting, including significant reduction in renal function, anemia and~     hyperkalemia.~      Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft~     biopsies with predominance in patients with proteinuria.~      Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve~     graft survival in proteinuric transplant recipients that have B7-1 staining on allografts.~     In addition, the absence of CNI nephrotoxicity and the potential protective effect of~     Belatacept on DSA production may be of benefit in this subset of transplant patients.~      Objectives:~      Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12~     months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative~     on kidney biopsy.~      Secondary: Assess the effect of Belatacept conversion in the percent change of renal~     function from baseline to 12 months; donor-specific anti-HLA antibodies presence and~     intensity (MFI); correlation of B7-1 positivity on immunofluorescence on biopsy with~     B7-1-expression in urine extracellular vesicles; adverse events; acute rejection episodes;~     blood pressure control; new onset diabetes; hyperlipidemia; graft survival; and patient~     survival.~   "
55750|NCT02327390|"~     This phase I trial studies the safety and best dose of ex-vivo activated lymph node~     lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in~     participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's~     lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells~     (called T cells) which can be activated (getting the cells to start up certain responses in~     the immune system) outside of the body in an approved laboratory. The activated T cells are~     then injected back into the same participant using an i.v. to help the participant's immune~     system to target melanoma. The participant will undergo regular blood testing to determine~     whether the X-ACT treatment has resulted in changes to the immune system and also whether~     the T cells which were given back to the patient persist in the blood stream over time. In~     addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's~     melanoma will be measured.~   "
55751|NCT02327377|"~     Functional abdominal pain (FAP), a pediatric pain condition without significant organic~     pathology, is a precursor to chronic pain and high healthcare utilization in young~     adulthood. This project aims to identify child and family characteristics that predict~     differential responses to a Cognitive Behavior Therapy intervention administered online to~     patients with FAP and their parents. The goal is to acquire scientific knowledge to guide~     individualized treatment of patients with FAP.~   "
55752|NCT02327364|"~     The purpose of this 3-year, multi-site, non-randomized, prospective, observational study is~     to characterize the natural history of Pearson Syndrome. The Syndrome is a rare~     mitochondrial disorder due to a large-scale mtDNA deletion. Children typically present in~     their 1st two years of life (most in infancy) with anemia and/or pancreatitis. Most~     individuals with Pearson Syndrome die in childhood. Those who survive evolve to Kearns-Sayre~     Syndrome/Chronic Progressive External Ophthalmoplegia (KSS/CPEO) although accurate survival~     estimates are not yet known.~   "
55753|NCT02327351|"~     Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta~     depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and~     unrelated donors in patients with primary immunodeficiency diseases~   "
55754|NCT02327338|"~     Objective- To see if the use of heat at home between physical therapy sessions results in~     better therapy outcomes in people with acute neck pain.~      Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with~     acute nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45~     minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of~     therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will~     use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps~     before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200~     mg / day) and the last 15 will be controls with conventional physical therapy.~   "
55755|NCT02327325|"~     Chronic low back pain (cLBP) is one of the most common and disabling conditions among US~     military Veterans. Although physical activity can improve cLBP outcomes, the majority of~     Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can~     help older Veterans with cLBP to increase their physical activity and improve associated~     outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk~     for functional limitations. The proposed project will be a pilot study of a telephone-based~     physical activity program or physical activity combined with cognitive behavioral pain~     management for older adult Veterans with cLBP. Older Veterans are of particular interest~     because prior studies of physical activity for cLBP have not addressed this vulnerable~     patient group. This study will also inform the VA about whether certain patients with cLBP,~     who have greater pain sensitivity, may benefit from other treatment to supplement a physical~     activity program.~   "
55756|NCT02327312|"~     To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per~     study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma~   "
55757|NCT02327299|"~     Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem,~     especially in developing countries. There are several strategies to correct iron deficiency~     in populations: besides supplementation with tablets, one of the most sustainable and~     effective strategies on medium term has been iron fortification, the addition of iron to~     regularly consumed foods. In fortification, the chemical nature of the compound to be added~     plays an important role: depending on the compound sensory qualities of the fortified foods~     can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate~     (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast~     cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer~     on the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to~     bouillon, as was recently suggested by in vitro experiments in the laboratory.~   "
55758|NCT02327286|"~     Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program~     implemented within the first year after a pregnancy complicated by gestational diabetes~     (GDM), in delaying or preventing the development of type 2 diabetes.~   "
55759|NCT02327273|"~     The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics~     (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in~     healthy subjects.~   "
55781|NCT02326987|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained~     Absorption by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to~     enable a drug to be dissolved irrespective of the surrounding environment and further~     absorbed up to colon. The investigators coined this Geometrically Long Absorption Regulated~     System(GLARS).~   "
55782|NCT02326974|"~     This research study is studying a combination of drugs as a possible treatment for breast~     cancer that has tested positive for a protein called HER2.~      The names of the study interventions involved in this study are:~        -  Trastuzumab emtansine (also called T-DM1)~        -  Pertuzumab~   "
60928|NCT02259738|"~     Human urinary kallidinogenase can promote the establishment of collateral circulation in the~     ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then~     increase the perfusion.~   "
55760|NCT02327260|"~     This project will pilot test an intervention to increase participation rates in cardiac~     rehabilitation and medication adherence among patients following a cardiovascular event. The~     intervention will use an educational video shown during referral to cardiac rehabilitation~     (before hospital discharge), along with a brief, telephone-delivered counseling session to~     increase motivation to participate in cardiac rehabilitation and take all cardiac~     medications as prescribed (following hospital discharge). One hundred twenty patients who~     have experienced a cardiovascular event, and who are eligible for cardiac rehabilitation,~     will be recruited to participate in the study. Three groups of participants (40 each) will~     be formed: a control group that receives standard care, a first experimental group that sees~     the educational video and receives motivational counseling to attend cardiac rehabilitation,~     and a second experimental group that receives motivational counseling to adhere to their~     medications as prescribed. It is expected that the experimental group participants will~     differ from the control group participants in rates of participation in cardiac~     rehabilitation (experimental group #1) and medication adherence (experimental group #2). If~     successful, this intervention could be used in hospital settings to increase patients'~     adherence behaviors.~   "
55761|NCT02327247|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended~     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories,~     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)~     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP~     Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.~   "
55762|NCT02327234|"~     The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen~     challenge testing and will investigate whether ibuprofen changes the response.~   "
55763|NCT02327221|"~     The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting~     of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population~     administered via the intravenous route as an infusion.~      The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and~     multi-injection study; followed with a 16-week phase with either the possibility for an~     open-label treatment part or a safety follow-up part with no injection.~      Then, the patients will be followed in an additional long-term safety follow-up, of maximum~     duration of 3 years from the first administration.~   "
55764|NCT02327208|"~     The objectives of this study are to: 1) determine effects of a prototype recovery food~     product providing supplemental energy on whole-body protein balance, skeletal muscle mass,~     and biomarkers of physiological status and strain during winter military training, and 2)~     determine the extent to which varying macronutrient composition (protein-based [PRO] versus~     carbohydrate-based [CHO]) of the food product modulates the physiological consequences to~     strenuous military training.~   "
55765|NCT02327195|"~     The purpose of this study is to assess whether methylphenidate affects time of emergence~     from isoflurane general anesthesia. Time to emergence was defined as the time from~     termination of isoflurane to extubation. After stopping isoflurane infusion, when the~     patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea~     will be extubated and the time will be recorded.~   "
55766|NCT02327182|"~     The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of~     MT-4666 administered once daily for 52 weeks with or without receiving a concomitant~     acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's~     Disease (AD).~   "
55767|NCT02327169|"~     The primary purpose of this study is to determine the safety profile and the maximum~     tolerated doses (MTDs/potential recommended phase 2 doses (RP2Ds) of the combination~     treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 +~     cetuximab, and MLN2480 + irinotecan in patients with advanced nonhematologic malignancies.~   "
55768|NCT02327156|"~     The investigator evaluated the motor and sensory block durations and the postoperative~     analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in~     patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered~     as a primary endpoint.~   "
55769|NCT02327143|"~     The aim of this study is to compare how much of the study drug gets into the blood stream~     when it is given as a single oral dose and as an intravenous infusion (given directly into a~     vein via a small needle).~      The study will also provide information on how well the study drug is tolerated when given~     as a tablet in combination with giving it intravenously, and information on any changes in~     heart function.~      The study will last about 10 days. Screening is required within 28 days before study drug is~     given.~   "
55770|NCT02327130|"~     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide.~     The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value~     (BDV). This study is seeking to determine if the breath delta value of critically ill adults~     is an early indicator of the onset of infection that may lead to sepsis.~   "
55771|NCT02327117|"~     Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The~     null hypothesis of this study was that TA has no effect on post surgical bleeding in~     patients undergoes TKA.~   "
55783|NCT02326961|"~     The primary objective of this study is to evaluate the safety and feasibility of~     intraarticular injection of Celution prepared adipose-derived regenerative cells injected~     into knees of patients with chronic knee pain due to osteoarthritis.~   "
55784|NCT02326948|"~     This case-control study matched by age and sex was performed to evaluate the region specific~     risk factors for gallbladder cancer in Jeju island, Korea.~   "
55785|NCT02326935|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     safe and 2) is treatment effective in improving the disease pathology of patients with~     Multiple Sclerosis and clinical outcomes.~   "
55786|NCT02326922|"~     Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing~     intrauterine contraceptive device is inadequate to be used as a medical line of treatment of~     dysfunctional uterine bleeding.~      The investigators aim to evaluate the therapeutic effect of the intrauterine system~     (Metraplant-E) in the treatment of dysfunctional uterine bleeding.~   "
55787|NCT02326909|"~     The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the~     diagnosis of Upper Urinary Tract Urothelial Carcinoma.~   "
55772|NCT02327104|"~     The dependence on tobacco is a predictable leading cause of death. The treatment based on~     the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco~     dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based~     Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The~     purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct~     in the treatment of smoking cessation instituted by the Ministry of Health, through the~     Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial,~     with a simple random allocation. 60 patients will participate in this study receiving~     treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will~     undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions~     of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory~     benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State-~     Brazil). Changes will be evaluated on several variables such as cessation of smoking,~     anxiety, depression, craving, positive and negative affects and will investigate the~     association of levels of mindfulness with smoking cessation. The data will be assessed at~     baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the~     initiation of the study, besides being subjected to evaluations of regularly planned~     maintenance in the protocol of Ministry of Health. For data analysis there will be used~     Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order~     to evaluate the effect of two types of intervention on the evolution of comorbidities and~     abstinence of patients.~   "
55773|NCT02327091|"~     The age-related increase in falls is strongly associated with a decline in muscle strength~     by the mechanism of sarcopenia. There has been great interest in developing approaches to~     counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle~     mass with vitamin D that have muscular effect. However, a limited number of studies~     demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in~     adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted~     in order to determine the effect of alfacalcidol on the upper-body muscle strength in~     Indonesian elderly women in age group of 60 or more who had low handgrip strength.~   "
55774|NCT02327078|"~     This is a Phase 1/2, open label study that will be conducted in 2 parts. The first part of~     the study (Phase 1) will consist of a dose-escalation assessment of the safety and~     tolerability of epacadostat administered with nivolumab in subjects with select advanced~     solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC),~     colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and~     B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). The second part (Phase 2) of the~     study will include expansion cohorts in the tumor types tested in Phase 1 (except diffuse~     large B-cell lymphoma (DLBCL) will be the only lymphoma permitted and Phase 2 will also~     include a cohort for glioblastoma) with a) historically good activity with nivolumab~     monotherapy, and b) with historically low activity with nivolumab monotherapy.~   "
55775|NCT02327065|"~     The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on~     pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.~   "
55776|NCT02327052|"~     One of the most challenging issues of chronic Chagas disease is to provide earlier detection~     of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new~     imaging modality with useful applications in several cardiac diseases, has been validated~     for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the~     investigators hypothesize that the longitudinal global strain (LGS) has an incremental value~     to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.~   "
55777|NCT02327039|"~     In Phase 2b/3 clinical trials, Dapagliflozin has been shown to raise HDL cholesterol levels~     by about 4 mg/dl (1 mmol/l), which is generally considered a clinically-meaningful change.~     As this HDL cholesterol increase is carried out with concomitant improvement in~     glucotoxicity and body weight reduction, it is possible that treatment with Dapagliflozin~     also improves HDL function. This is important because clinical, epidemiological and~     experimental studies indicate that HDL function may be more important than HDL cholesterol~     levels in determining the protective cardiovascular effects of HDL particles. In addition,~     knowing the effects of Dapagliflozin on HDL function can help interpreting the increase in~     HDL cholesterol levels observed in Dapagliflozin-treated patients. Finally, discovery of~     extra-glycemic effects of Dapagliflozin will shed new light on the potential benefits of~     therapy with Dapagliflozin and SGLT2i in general. So far, no study evaluated the effects of~     Dapagliflozin (or other SGLT2i) on HDL function.~      The investigators hypothesize that Dapagliflozin, in addition to raising HDL cholesterol~     levels, also increases HDL functionality, measured as reverse cholesterol transport and~     anti-oxidant capacity, in patients with T2DM~   "
55778|NCT02327026|"~     The aim of this study is to improve the management of patients in cardiac arrest, and this~     by comparing two initial airway management methods: Tracheal intubation and bag-valve-mask~     ventilation.~      The survival rate at 28-day with favorable neurological function will be compared in the~     tracheal intubation group versus the bag-valve-mask group~   "
55779|NCT02327013|"~     The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult~     patients with ADHD in a 12 weeks study.~   "
55780|NCT02327000|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained~     Absorption by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to~     enable a drug to be dissolved irrespective of the surrounding environment and further~     absorbed up to colon. The investigators coined this Geometrically Long Absorption Regulated~     System(GLARS).~   "
55788|NCT02326896|"~     Risk factors for difficult intubation are well described in anesthesiology. But intubation~     in the intensive care unit (ICU) is a challenging issue, associated with severe~     life-threatening complications. Non-anesthesiologist trainees performing ICU intubation may~     not fully appreciate the potential difficulty and complications.~      Therefore in this retrospective analysis the MACOCHA score will be used to determine~     difficult intubation in the ICU and predict intubation failure.~   "
55789|NCT02326883|"~     This pragmatic clinical trial will evaluate the effectiveness of two population-based~     outreach programs for preventing suicide attempts among patients identified as at-risk. The~     study will be conducted at Group Health (the lead site) and at HealthPartners and KP~     Colorado. Electronic health records will be used to identify outpatients aged 18 or older~     who respond to a routinely administered PHQ depression questionnaire by reporting thoughts~     of death or self-harm most of the days or nearly every day. This trial will be limited~     to patients receiving care from one of the three participating health systems. Eligible~     patients will be automatically assigned to continue in usual care (1/3) or to either of the~     two intervention programs (1/3 each). Those assigned to usual care will not be contacted at~     all by study staff and will continue to receive usual care from treating primary care and~     mental health providers. Both intervention programs involve outreach by Epic secure~     messaging (with optional telephone outreach for those not reading messages). The Care~     Management intervention includes routine outreach to assess ongoing risk of suicide attempt~     and care management to monitor and facilitate ongoing engagement in outpatient follow-up.~     The Care Manager will coordinate care with treatment by primary and behavioral health care~     providers using Epic Staff Messaging (or telephone contacts if necessary). The Skills~     Training intervention uses an online skills training program to support patients in~     developing and using self-management skills for emotion regulation and crisis management. A~     Coach will monitor each participant's use of the program and send periodic messages (using~     Epic secure messaging) to encourage and support use of the program and practice of program~     skills. Each intervention continues for up to one year. In all three groups (Usual Care,~     Care Management, and Skills Training) virtual data warehouse data will be used to identify~     likely suicide attempts over 18 months following randomization. Analyses will compare risk~     of suicide attempt among all those randomized, regardless of response to the initial~     invitation or level of participation in the intervention programs. Comparison of all those~     randomized is the only scientifically valid method for assessing the overall impact of~     either program on population-level risk of suicide attempt.~   "
55790|NCT02326870|"~     The main objectives of this study are to evaluate the performance and ease of use of the~     Follow me mode of the AutoLap system during general and gynecological laparoscopic~     procedures.~   "
55791|NCT02326857|"~     Background:~      - Researchers want to learn more about breast cancer in Latin American women. They also want~     to learn how and why women respond differently to standard treatment. Tissue and blood~     samples from women with breast cancer are needed to study this disease in order to find new~     ways to prevent, diagnose, and treat it.~      Objective:~      - To learn more about the biology and genetics of breast cancer in Latin American women.~      Eligibility:~      - Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II~     or III breast cancer. They must still be active and able to self-care.~      Design:~        -  Participants are only agreeing to have extra tissue or blood samples collected. They~          are also letting tissue left over from surgery be used for research. No procedures~          outside of standard care will be done.~        -  Participants may have a medical history, physical exam, and blood tests. They may have~          a pregnancy test. They may have an ultrasound, mammogram, and other scans. They may~          have an intravenous needle placed in an arm vein.~        -  Participants may have a core biopsy. For this, a needle is inserted into the breast. A~          piece of tissue is extracted.~        -  Participants who have chemotherapy may have blood taken after treatment/before surgery.~          Tissue may also be collected.~        -  Participants will complete a questionnaire. It will ask about their social and economic~          background. It will ask about their family history of cancer. It will also ask about~          access to diagnosis and treatment of breast cancer.~        -  Participants may be followed for up to 5 years.~   "
55792|NCT02326844|"~     Background:~      - The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some~     people. It is a PARP inhibitor. It works on tumor cell DNA damage repair process.~     Researchers want to see if BMN 673 shrinks cancer again in women with ovarian cancer and~     whose cancer initially got shrunk but grew back on the first PARP inhibitor.~      Objective:~      - To study BMN 673 (talazoparib) in people with ovarian cancer born with a BRCA mutation and~     whose cancer got shrunk but became worse after they took a similar drug.~      Eligibility:~        -  Women at least 18 years old:~        -  with recurrent and/or metastatic gBRCAm-associated ovarian cancer AND~        -  whose disease is growing after already being treated with PARP inhibitors AND~        -  with no other treatment(s) in between the first PARP inhibitors and a screening visit.~      Design:~        -  Participants will be screened with medical history, physical exam, and heart and blood~          tests.~        -  Participants will take the study drug by mouth once daily. They will take the drug in~          28-day cycles.~        -  They will keep a diary of doses and any side effects.~        -  Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may~          include:~        -  Blood tests~        -  Physical exam~        -  Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will~          lie in a machine that takes pictures of their body.~        -  Ultrasound~        -  Participants will have a biopsy before starting the study drug. A small piece of tumor~          tissue will be removed by needle, guided by a scan. They may have two more biopsies~          later.~        -  Participants will be followed for 30 days after taking the last dose of study drug. A~          physical exam, blood tests, and CT or other scans will be done.~        -  Participants will have follow-up calls to ask about any side effects.~   "
55793|NCT02326818|"~     Background:~      - It is hard for people with arm spasticity and focal hand dystonia to control their arm and~     hand muscles. They are often treated with botulinum toxin (BoNT) injections.~     Electromyography with electrical stimulation (e-stim) and ultrasound are used to find~     muscles for BoNT injection. Researchers want to learn which method is faster and more~     comfortable.~      Objective:~      - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand~     dystonia and upper limb spasticity.~      Eligibility:~      - Adults 18 and older with focal hand dystonia or arm spasticity who have been getting~     onabotulinumtoxin-A injections in protocol 85-N-0195.~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Participants will push or pull on a device that measures arm strength. They will have a~          neurologic exam. Women will have a pregnancy test.~        -  Participants will have a BoNT injection using either e-stim or ultrasound.~        -  For e-stim, sticky pads will be placed on the arm. A needle will be placed in the~          muscle. A small electric shock will be given through the needle. Then the injection~          will be given.~        -  For ultrasound, a probe will be moved across the skin. A screen will show an image of~          the muscles. Then the injection will be given.~        -  Participants will have a second injection 3 months later. They will have the method~          that was not used for their first injection.~        -  After each session, participants will rate their experience.~        -  Participants will have follow-up visits 1 month after each injection. They will be~          examined and asked about their response to treatment. Arm strength will be measured.~   "
55794|NCT02326805|"~     This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen~     [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer~     undergoing active surveillance. Vaccines made from a person's tumor cells may help the body~     build an effective immune response to kill tumor cells that express PSA.~   "
55843|NCT02326168|"~     Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG~     immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG~     vaccination, patients will then receive standard strength BCG intravesical therapy once a~     week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately~     2 hours. While the BCG is retained in the bladder the patient should be repositioned every~     30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a~     cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6~     months.~   "
55795|NCT02326792|"~     The fatigue of the trunk extensor muscles is often reported in people with the chronic low~     back pain (LBP). Evidences have showed that the strengthening muscular by the training of~     the lumbar spinal muscles is efficient to decrease the pain and disability symptoms of~     patients with the chronic LBP. Also, some studies have reported improve of the strength and~     endurance of the back muscles from of this type of training muscular. However, the exercise~     prescription for the trunk extensor muscles during the training is still not clear in the~     literature. In fact, no study has showed any differences between one and three sets of~     specific lumbar exercise with regard to better prescription of training in healthy subjects~     (e.g; preventive action) as well as in LBP subjects (e.g; intervention action).~   "
55796|NCT02326779|"~     The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage~     II-III esophageal cancer patients.~   "
55797|NCT02326766|"~     This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting~     plasma metabolomes.~   "
55798|NCT02326753|"~     The purpose of this study is to assess the adequacy of mask ventilation with the different~     sized-oropharyngeal airway.~   "
55799|NCT02326740|"~     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of~     pyoderma gangrenosum (PG).~   "
55800|NCT02326727|"~     Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer~     cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer~     Registry has noted an improved 5-year survival in patients who received epidural analgesia~     during surgery for colorectal carcinoma.~   "
55801|NCT02326714|"~     The purpose of this trial is to investigate the effect and safety of auricular acupressure~     on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms:~     Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for~     three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic~     profile will be determined.~   "
55802|NCT02326701|"~     Echocardiographic assessment of right ventricular function is an important diagnostic tool,~     and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a~     new technique has been developed and used for evaluating both the left and the right~     ventricle function. This technique, called two dimensional (2D) speckle tracking, is based~     on detecting speckles in the myocardial tissue and using them as acoustic markers. The~     movement of these speckles represents the movement of the tissue, and allows us to evaluate~     its function, contraction and relaxation, this by calculating the strain rate, which is the~     speed of the speckles, and the strain, which is the distance between them.~      In the last few years this technique has been used to evaluate the systolic function of the~     right ventricle in several pathological conditions, such as pulmonary hypertension,~     pulmonary embolism and amyloidosis. Nonetheless, so far there has been little data on the~     normal RV strain and strain rate values.~      In this study the investigators aim to validate two dimensional (2D) speckle tracking~     measurements of the RV function by comparing them to strain measurements by cardiac MRI.~     Each patient performing cardiac MRI for any indication will perform an echocardiography~     examination in addition, and strain analysis performed on the cardiac MRI will be compared~     with two dimensional speckle tracking analysis performed on the echocardiography.~   "
55803|NCT02326688|"~     Reproducibility assessment of a quantitative measure of the amount of trunk compensation by~     kinematic analysis in a grasping task in stroke patients.This maladaptive trunk~     compensation is suspected to be underlined by arm non-use in some patients, since this~     abnormal movement impairs the ability of patients to correctly flex their shoulder and~     extend their elbow during grasping.~   "
55804|NCT02326675|"~     Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to~     the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to~     treat the cancer. A number of treatment factors have been shown to influence the incidence~     and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy~     before stem cell transplantation can cause severe oral mucositis and is often the side~     effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in~     the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis~     caused by high-dose melphalan alone or given in combinations used in pre-transplant~     conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16).~     The specific aims of the study are: 1) to assess tolerability of cryotherapy given during~     chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing~     etoposide-induced mucositis.~   "
55805|NCT02326662|"~     This research investigates the use of autologous neural stem cells in patients with complete~     traumatic spinal cord injury.~   "
55806|NCT02326649|"~     This study will test the capability of a non-invasive instrument (the PhysioFlow impedance~     cardiography instrument) to measure cardiac output in patients with congenital heart disease~     (CHD). This instrument works by placing electrodes on the skin of a patient and measuring~     electrical impedance through the chest, which is proportional to blood volume and blood flow~     at any given time. The instrument has been validated in patients with structurally normal~     hearts, but in the only two studies using it for patients with CHD, it was deemed too~     inaccurate for clinical use. The manufacturer of the device would require access to data on~     the patients in order to improve its accuracy, and that has not been feasible thus far. This~     study would begin by comparing cardiac output based on the PhysioFlow monitor to standard~     techniques, then after possible changes to the instrument to enhance accuracy, would test~     the instrument again in the same way.~   "
55807|NCT02326636|"~     The purpose of this research is to investigate the efficacy of transplanting screened donor~     fecal material in treating patients with recurrent Clostridium difficile infection.~     Participants with refractory Clostridium difficile infection will be given healthy donor~     stool administered by colonoscopy or enema and their response will be evaluated by symptom~     questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.~   "
55844|NCT02326155|"~     An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™~     in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)~   "
55845|NCT02326142|"~     The primary objective of this study is to assess the efficacy of a single dose of OBE001, an~     oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared~     to placebo.~   "
55808|NCT02326623|"~     Many medical procedures aimed at helping children can cause them pain and distress. If~     children have certain levels of pain or distress, it can have long lasting negative effects.~     The emergency department can be a very stressful place for children and their parents. There~     are also many procedures that children may have in the emergency department that can cause~     pain and distress. These include procedures such as needle pokes, stitches, or setting a~     broken bone. Two common methods of managing a child's pain in the emergency department are~     drugs and distraction. Drugs are not always practical and may come with unwanted side~     effects. Distraction is often used by parents or health professionals to help children deal~     with pain and stress. Distraction can lower the child's pain and distress by moving their~     attention from the painful experience, for example a needle poke, to a more positive feeling~     such as watching a movie, playing a game, or listening to music. This study will test if~     iPads are useful to help lower pain and distress for children (ages 6 to 11 years) who are~     visiting an emergency department and need an intravenous line put in. The results from this~     study could be important for many children receiving medical care, as distraction is safe~     and the use of iPads is enjoyable for many children.~   "
55809|NCT02326610|"~     SGA Infants who do not show a developmental catch-up growth within the first 6 months of~     life fall in the category of SGA children shown to have defects in the GH/IGF-I axis,~     resulting in partial hGH/IGF-I deficiency.~      Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I~     deficiency in SGA children can be the major or contributory cause of to their~     neurodevelopmental deficits~      To assess the effect of early growth hormone treatment given to symmetrical small for~     gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and~     growth between birth and 6-12 months.~      The study is an innovative research not previously performed for improving~     neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the~     safety of use of GH has not been reported, however based on multiple studies assessing use~     of GH in infants and young children, it is reasonable to similarly expect no short and~     long-term adverse effects.~      The study will take place at the Tel Aviv Medical Center only.~   "
55810|NCT02326597|"~     Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations~     affecting 100,000 individuals in the US, largely of minority origin and associated with~     substantial morbidity, premature mortality, individual suffering, healthcare costs and loss~     of productivity. Disease modifying treatments such as Hydroxyurea, chronic blood transfusion~     and curative bone marrow transplantation are offered to patients based on physician~     preference and current practice informed by clinical trials. Decision aids are tools that~     could help translate evidence from these sources into practice by helping clinicians involve~     patients in making deliberate choices based on accessible information about the options~     available and their outcomes and to help them make decisions based on their values and~     preferences.~      The overarching goal of this project is to develop and implement a web based decision aid~     individualized to patient characteristics to help patients with SCD achieve more accurate~     perception of risks and benefits of treatment options and make decisions in congruence with~     their values and preferences.~      The investigators will conduct needs assessment interviews as indicated by the data for~     saturation and validation of findings. The investigators will conduct beta testing of the~     web-based decision aid to clarify development and validate findings. The investigators will~     use a randomized controlled trial of the effectiveness of a web-based decision aid to give~     patients accurate information about risks and benefits of therapies and enable them to make~     decisions based on their individual values and preferences.~      To provide accurate information to patients and caregivers about the risks and benefits of~     various treatments for sickle cell disease and to enable them to make informed and involved~     therapeutic decisions based on their values, preferences and stated goals.~   "
55811|NCT02326584|"~     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself~     (monotherapy) or in combination with other standard treatments. The main purpose of this~     study is to find the best dose and schedule for SGN-CD33A when given in combination with~     standard induction treatment, in combination with standard consolidation treatment, or by~     itself for maintenance treatment. This will be determined by observing the dose-limiting~     toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In~     addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will~     be assessed.~   "
55812|NCT02326571|"~     Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH)~     constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the~     larger population of patients suffering from cerebral thrombosis. Development of brain edema~     seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is~     only understood fragmentarily.~      By using multimodal neuro monitoring, the investigators seek to investigate~     electrophysiological and metabolic processes, which seem to accompany the formation of edema~     and clinical deterioration in patients suffering from sICH.~   "
55813|NCT02326558|"~     The purpose of this study is to evaluate the feasibility, safety and efficiency of zero~     ischemia laparoscopic microwave ablation-assisted enucleation in comparison with~     conventional laparoscopic nephron-sparing surgery in the treatment of T1a renal cell~     carcinoma.~   "
55814|NCT02326545|"~     Anxiety is the most prevalent form of children's mental health problems and demand far~     exceeds treatment availability. Even when children do have access to care, evidence-based~     treatments such as cognitive-behavioural therapy have several limitations: they are largely~     didactic, leaving children unmotivated and disengaged; children get little practice in using~     the skills they are taught, creating a large gap between their knowledge and their everyday~     behaviour and therapy is costly, often prohibitive for the children that most need it.~     Therapeutic video games can address each of these gaps: they are engaging contexts through~     which children practice skills (rather than memorize lessons), and they cost substantially~     less than conventional approaches. The proposed research will test the effectiveness of~     MindLight, an innovative video game that targets childhood anxiety problems. MindLight~     incorporates several evidence-based strategies including relaxation and exposure techniques,~     attention bias modification methods, and neurofeedback mechanics that together produce an~     immersive game world through which children learn to manage and overcome anxiety symptoms.~     Two randomized controlled studies with 8-16 year old children are proposed to test the~     effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at~     children at risk for developing serious anxiety problems and the second is a clinical trial~     aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to~     the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants~     in the prevention sample will play a commercial video game with a similar theme for the same~     amount of time whereas control participants in the clinical sample will use an online~     cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety~     levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g.,~     comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential~     mechanisms of change associated with successful intervention effects.~   "
55815|NCT02326532|"~     The overall goal of this proposal is to address barriers to the use of patient reported~     outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.~   "
55816|NCT02326519|"~     Routine data collection will be conducted during normal sinus rhythm and AV synchronous~     pacing for approximately 20 minutes. The data collected will then be processed and the P, R~     and T wave amplitudes will be measured.~   "
55860|NCT02325947|"~     The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton~     technology based on EEG patterns recognition matching to motor imagery in post-stroke~     patients with hand paresis.~   "
55817|NCT02326506|"~     Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute~     cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable~     and adequate support. To date, no reliable measurement method exists to monitor drainable~     volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac~     recovery.~      Previous (pre)clinical studies showed that the calculation of the dynamic filling index may~     provide a valuable parameter to monitor the drainable volume in patients supported by VAELS.~     In addition, a case report showed that measurement of the dynamic filling index could~     successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in~     the ICU.~      This study will assess the dynamic filling index as a representation for drainable volume~     and cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS~   "
55818|NCT02326493|"~     Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do~     not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement~     and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals~     to the individual patient. However, the best strategy to optimize lead positioning and~     device programming still remains to be established. Earlier work in our research group~     suggests that the vector cardiogram (VCG) can be used to determine the optimal LV lead~     position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a~     VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested~     that the best position for the LV electrode is the region of latest electrical activation.~     The region of latest electrical activation can be identified by measuring the electrical~     delay on the LV lead (LVLED) during implantation. The objective of this study is to~     investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and~     whether VCG and LVLED can be used to determine the optimal LV lead position.~   "
55819|NCT02326480|"~     Identify news genetic causes of different type of obesity (syndromic, familial or isolated~     obesity) by highlighting new mutations or new implied genes~   "
55820|NCT02326467|"~     Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate~     (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated~     infections (HAIs). CHG is believed to be superior to other forms of antiseptics because,~     when it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has~     been shown to be well tolerated in patients 2 months of age and older. However there is~     limited evidence to support the use of topically applied CHG in infants less than 2 months~     of age because of potential safety concerns in this population. The purpose of this study~     will be to describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care~     Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the~     incidence of skin problems and CHG blood levels.~   "
55821|NCT02326454|"~     This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium)~     activated by an intraurethrally placed drug-activating device. Two different light doses~     will be tested against placebo groups in this 4-arm study.~   "
55822|NCT02326441|"~     The purpose of this study is to determine the safety and tolerability of the study drug~     KX2-361 and to determine how much of the study drug enters the bloodstream, in patients with~     advanced malignancies that have not responded to conventional therapies.~   "
55823|NCT02326428|"~     Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the~     formation of blood clot in the major vessel which gives blood supply to a certain part of~     the brain. At early time, within the first 4,5 hours, the conventional treatment is to try~     to dissolve this blood clot with a medication (thrombolytic drug) which is administered to~     the blood through the needle in the vein. If the clot still remains there, additional~     treatment is possible - going directly to the clot via artery and taking it out with a~     special device. Though this treatment is already used in many stroke centres, its benefit is~     not clearly proven. The purpose of the present study is to evaluate the benefit and safety~     of this additional treatment for the big stroke in patients fulfilling criteria for and~     receiving conventional treatment within 4.5 hours of onset, as compared to conventional~     treatment only.~   "
55824|NCT02326415|"~     The aim of this study is to reduce the postoperative hospital stay, without increasing~     morbidity and mortality postoperative, expressed in terms of rate of complications and~     readmissions.~   "
55825|NCT02326402|"~     This study is intended to be a multicenter, prospective observation registry. By collecting~     prospective descriptive data, provide insight into disease defining characteristics~     resulting in the clinical decision to use TandemHeart for mechanical support and enhance~     knowledge of best practice regarding clinical management, weaning and removal/exit~     strategies.~   "
55826|NCT02326389|"~     The purpose of this study is to evaluate the potential benefits of combining cognitive~     remediation and exercise in improving cognitive functioning and response to psychiatric~     rehabilitation.~   "
55827|NCT02326376|"~     A non-interventional, post authorization safety study to evaluate the safety of Kineret in~     the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care~     with regard to serious infections, malignancies, injection site reactions, allergic~     reactions and medication errors, including re-use of syringe.~   "
55828|NCT02326363|"~     This study will provide important information concerning the used of mindfulness-based~     relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed~     primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the~     risk of relapse to substance use is highest during the period immediately following~     treatment and attention to continuing care is critical. If this trial demonstrates that MBRP~     promotes sustained abstinence and improved functional outcomes, this will provide a valuable~     treatment to facilitate rehabilitation and recovery for Veterans with SUDs.~   "
55841|NCT02326194|"~     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14~     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious~     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only~     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine~     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry~     products which could be stored at 4℃.~      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial. This study will determine the safety and side-effect profile, and immunogenicity of~     an investigational Ad5-EBOV vaccine.~   "
55829|NCT02326350|"~     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of~     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive~     Care Units and is associated with a high mortality and a high morbidity in those who~     survive. There is a large economic burden with direct healthcare costs, but also indirectly~     due to the impact on the carer and patient through their inability to return to full time~     employment. There is little evidence for effective drug (pharmacological) treatment for~     ARDS. Blood cells called platelets have increasingly been recognized to play a key role in~     the development of ARDS. There is increasing information that aspirin, a drug which is~     widely used to treat heart disease, might be important in treating ARDS. We plan to test if~     aspirin will help in the treatment of ARDS. To do this we will divide patients suffering~     from ARDS into two groups, one of which will get aspirin and the other a harmless dummy (or~     placebo) tablet who will then be followed up to determine if lung function improves. If~     effective this may lead to further research to determine if aspirin is effective in patients~     with ARDS. This project will also provide new information about mechanisms in the~     development of ARDS leading, potentially, to other new treatments.~   "
55830|NCT02326337|"~     The purpose of this study is to evaluate the efficacy, safety and economical benefits of~     Cyclical Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot~     ulcers. All subjects will wear a standardized off-loading device and use advanced moist~     wound therapy (AMWT) dressings. Half the subjects will use the TWO2 device, while the other~     half will use a sham device.~   "
55831|NCT02326324|"~     This study aims to investigate the diagnostic and prognostic utility of cardiovascular~     magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing~     CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR~     indices will be related to the presence and severity of cardiovascular disease and other~     markers of cardiovascular and health status.~   "
55832|NCT02326311|"~     In this phase III clinical randomized study, fixed intermittent administration (one month~     ON/one month OFF) of TKIs (control arm), will be compared with progressive intermittent~     administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for~     the 2nd year; one month ON/three months OFF for the 3rd year) (experimental arm). Imatinib~     (Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the~     same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML~     patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard~     treatment with IM, NIL, or DAS will be randomized 1:1 to receive fixed INTERIM or~     progressive INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,)~     and by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a~     progressive increase of intermittent treatment discontinuation until 3 months is able to~     improve QoL outcomes with respect to fixed intermittent administration of TKIs (control~     arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30~     outcome measure will be assessed throughout the three years follow up period. The QoL~     results in this trial will be presented in accordance with high methodological quality~     criteria for documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT~     PRO recommendations. Furthermore, the study could give additional clinical and biological~     information to optimize TKIs therapy in elderly.~   "
55833|NCT02326298|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when~     administered every 2 weeks.~   "
55834|NCT02326285|"~     This study is designed as a single arm, un-controlled, open-label, multi-center hypothesis~     generating two-stage phase II trial. It is based on the assumption that the proposed~     treatment scheme doubles the rate of pathologic complete remission in Mutated epidermal~     growth factor receptor (EGFRmt) + NSCLC patients compared to historical control data from~     standard treatments.~      Patients with NSCLC and activating EGFR mutation in stages II, IIIA and IIIB eligible for~     induction therapy with docetaxel and cisplatin and gefitinib~      Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and~     induced with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated~     gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the~     4th week after d1 of the last cycle.~   "
55835|NCT02326272|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.~   "
55836|NCT02326259|"~     The investigators are doing this research for two reasons. The first is to see how the~     retina (back of your eye) changes when your blood sugar is treated with medication for the~     first time. This will help us better understand the progression of a condition known as~     Diabetic Retinopathy. The second reason is to provide diabetic blood samples, which will~     possibly help identify biomarkers for diabetic retinopathy. Biomarkers are things that~     indicate the presence of a specific condition, and indicate a higher likelihood of~     developing that condition.~   "
55837|NCT02326246|"~     The purpose of this study is to investigate the hypothesis, that mMRI provides a more~     accurate and secure interpretation of the aggressiveness of prostate cancer initially/before~     mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on~     gleason score upgrade, risk classification upgrade and changes in treatment strategy (active~     surveillance vs. operation).~   "
55838|NCT02326233|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of~     the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.~   "
55839|NCT02326220|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the~     effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments~     in patients with HeFH undergoing LDL apheresis therapy.~   "
55840|NCT02326207|"~     The purpose of this study is to determine incidence of ventilator-associated pneumonia~     compared between weekly and no routine ventilator circuit changes in neonatal intensive care~     unit~   "
55872|NCT02325791|"~     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and~     immunogenicity of REGN2222 in infants born no more than 35 wGA (weeks gestational age), who~     are no more than 6 months of age at the time of enrollment in their respective geographic~     location. In order to optimize the potential benefit in this vulnerable population, we will~     conduct this study during the RSV season using dosing regimens that are expected to be~     effective.~   "
55846|NCT02326129|"~     The investigators wants to determine if 11β-HSD1 activity will be positively associated, and~     5α-reductase activity negatively associated, with (a) degree of insulin resistance defined~     by the homeostatic model assessment of insulin resistance index (HOMA-IR) and (b) worsening~     glycemic control defined by higher HbA1c and impaired fasting glucose in a group of obese~     children and young adults with or without type 2 diabetes compared to lean children and~     young adults without diabetes. The investigators also want to identify key metabolic~     signatures associated with diabetes using metabolomic profiling.~   "
55847|NCT02326116|"~     The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed~     prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.~   "
55848|NCT02326103|"~     The study is aimed to evaluate the additional role of ciprofloxacin therapy in severe~     alcoholic hepatitis combined to prednisolone therapy in an open-label placebo controlled~     manner.~   "
55849|NCT02326090|"~     The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA~     Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
55850|NCT02326077|"~     Objectives:~        -  Evaluation of the correlation between the sonographic parameter and clinical findings~          (e.g. digital examination) in any cephalic (not only occipital anterior) position~        -  Examination of the relationship between various sonographic parameters~        -  Determination of intraobserver and interobserver variation in obtaining the sonographic~          measurements~        -  Analysis of the temporal variation of the different sonographic measurements in normal~          spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior~          versus those with persistent occiput posterior~        -  Establishment of a sonopartogram that should replace in an objective way Friedmann~        -  Establishment of cut-off values that may help clinicians to choose between vaginal~          operative delivery or caesarean section~        -  Another interesting aspect of intrapartum transperineal ultrasound imaging is whether~          there is a psychological benefit to the patient in being able to follow on the~          ultrasound screen how fetal head descent and position are being assessed objectively.~   "
55851|NCT02326064|"~     Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these~     cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main~     difficulties. The first is to establish an early diagnosis. The second is to differentiate a~     benign tumor, a malignant tumor.~      To date, there is only one biological tumor marker routinely performed before an ovarian~     cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and~     show a sensitivity and specificity unsatisfactory in view of the severity of the disease.~      The principal investigator therefore propose to evaluate a new tumor marker, as well as its~     use in algorithms to help differentiate benign from malignant tumors, and allow earlier~     diagnosis in cases of ovarian cancer.~   "
55852|NCT02326051|"~     Evaluation of the effect of altering the timing of initiation of low molecular weight~     heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid~     syndrome (APS)~   "
55853|NCT02326038|"~     Traditionally, memory impairments in the elderly population are treated using cholinesterase~     inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in~     cognition and is especially of interest in healthy ageing because of the role in processing~     speed and cognitive control. To what extent dopamine treatment improves memory and attention~     in older impaired individuals is unknown. However, such an effect is conceivable because of~     the close relationship between memory and attention in aging and since improved processing~     speed and cognitive control may lead to improved memory.~      The investigators aim to examine, in the impaired older population, whether a treatment~     using methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and~     memory. The study will be conducted according to a cross-sectional, double-blind,~     placebo-controlled, 2-way cross-over design. 20 male and female patients with Mild Cognitive~     Impairment (MCI), amnestic type, aged above 60 years of age; 20 male and female patients~     with MCI, non-amnestic type, will be recruited from the Orbis Medical Centre. Participants~     will be treated once with 20 mg methylphenidate (MPH) and once with placebo. All medications~     will be administered orally with a capsule. The treatment order will be established by~     counterbalancing.~   "
55854|NCT02326025|"~     The purpose of this study is to assess how the body handles olaratumab when it is given with~     another drug called doxorubicin.~      The safety and tolerability of these drugs will be studied. Each participant will complete~     two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to~     receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive~     olaratumab alone until discontinuation criteria are met.~      Screening is required within 21 days prior to first dose.~      Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab~     when given with doxorubicin.~      Participants may only enroll in one part.~   "
55855|NCT02326012|"~     The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy~     for Adolescents (ERITA) who self-harm.~   "
55856|NCT02325999|"~     The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine~     with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve~     Disease-free survival ？~   "
55857|NCT02325986|"~     The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy~     concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative~     locoregional recurrence of esophageal squamous cell carcinoma.~   "
55858|NCT02325973|"~     The purpose of this study is to assess whether the Index of Microcirculatory Resistance~     (IMR) can be considered a prognostic predictor for the occurrence of events at one year of~     follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial~     Infarction (STEMI) patients.~      Any correlation between IMR and the short and medium term outcomes, defined as~     cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF),~     resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be~     assessed in the study.~   "
55859|NCT02325960|"~     This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group~     Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2~     Diabetes Patients Inadequately Controlled With Metformin Monotherapy.~   "
55861|NCT02325934|"~     Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination~     tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB). For~     patients with swallowing difficulties, administration of whole tablets can be problematic~     and tablets are cut or crushed to ease administration. In addition if HIV patients develop~     opportunistic infections, patients can become severely ill and may end up on the intensive~     care. Patients at the intensive care might not be able to swallow medication. Therefore it~     is useful to know if it is possible to administer STB through a different route, like a~     feeding tube. If STB can be crushed or dissolved and given through a catheter it is also~     useful to know if it can be given with drip feed.~      Currently there is no information about crushing STB tablets. Crushing STB tablets into a~     liquid medium has not been studied and is not recommended according to the SPC text.~     Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets~     can lead to altered pharmacokinetics of drugs.~      It is important to know whether pharmacokinetics are influenced by crushing of tablets as~     low concentrations are associated with virologic failure. Therefore higher doses might be~     needed. In addition, higher Cmax and/or exposure can lead to toxicity. As a result~     therapeutic drug monitoring is advised, or crushing the drug is a contra-indication based on~     the available data.~      It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a~     decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion~     with omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering~     effect influencing the absorption of elvitegravir. It is probably a local gastrointestinal~     complexation phenomenon, similar to what has been observed with other HIV integrase~     inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation~     formers may be expected. Especially considering the active binding sites of elvitegravir~     which bind magnesium metal ion cofactors. Although there is data that STB can be ingested~     with a protein rich drink, it is unclear if foods or liquids containing high amounts of~     magnesium or other cations can cause this same interaction.~      Therefore this study will be conducted to investigate whether crushed and suspended STB and~     crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.~   "
55862|NCT02325921|"~     Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities~     such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After~     (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not~     be identified on diagnostic imaging. With improved imaging techniques available, leading to~     improvements in characterisation of renal tumors, the number of unnecessary resections may~     be reduced. The objective of this study is to evaluate the diagnostic performance of~     diffusion weighted magnetic resonance imaging (DW-MRl) in assessing the nature of renal~     masses, including the use of diffusion tensor imaging (DTI).Therefore patients >18 years of~     age scheduled for undergoing (partial) tumor nephrectomy will undergo one additional MRI~     examination.~   "
55863|NCT02325908|"~     The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis~     patient affects him or her. Body hydration is the amount of fluid in the human body and~     known to be related to blood pressure. Too much fluid can lead to high blood pressure which~     can cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a~     method that may be used to measure body hydration. This can be applied in the whole body,~     arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk.~     BIS measurements can be used to assess optimal hydration status which is defined as a~     patient's ideal weight after completing a dialysis treatment. The investigators hypothesize~     that your target weight may be better estimated by the BIS. The results of this study, in~     particular the continuous measurement of calf hydration which is associated with the~     hydration of the whole body, may provide useful information about physiologic (healthy)~     body hydration. It may possibly help to improve treatment procedures for patients in the~     future. The Renal Research Institute plans to enroll 100 chronic hemodialysis patients and~     200 healthy controls in this study.~   "
55864|NCT02325895|"~     The objective of the investigators current study was to examine whether 50 g dried plum~     would be as effective as 100 g dried plum in reversing bone loss in osteopenic older~     postmenopausal women.~   "
55865|NCT02325882|"~     The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based~     intravenous patient controlled analgesia (PCA) improves postoperative pain compared with~     conventional thoracic epidural and intravenous patient controlled analgesia after radical~     open gastrectomy.~   "
55866|NCT02325869|"~     DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance~     of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.~   "
55867|NCT02325856|"~     A reasonable and simple algorithm was used to guide the dry weight determination with Body~     Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze~     the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid~     management on the incidence of dialysis morbidities and clinical outcomes in maintenance~     hemodialysis (MHD) patients.~   "
55868|NCT02325843|"~     Ocular chemical burn is one of the cause of vision loss in our country, and there are no~     satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological~     characteristics of self-renewal, immune regulation, multidirectional differentiation and~     tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC~     can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to~     access the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in~     human.~   "
55869|NCT02325830|"~     The objective of this prospective, multi-center, randomized, double-blind trial is to assess~     the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral~     regurgitation (FMR) associated with heart failure, compared to a randomized Control group~     which is medically managed according to heart failure guidelines.~   "
55870|NCT02325817|"~     The purpose is to observe and evaluate the safety and efficacy of drug-eluting balloon in~     the treatment of patients with bifurcation lesions of coronary artery.~      Note: the drug-eluting balloons are manufactured and supported by Liaoning Biomedical~     Materials R&D Center Co., Ltd. (LBC).~   "
55871|NCT02325804|"~     The main purpose of this study is to assess metabolic effects (decreased amount of body fat~     content, insulin sensitivity and lipid profile improvement) of weight loss intervention~     based on specific life style counseling (low calorie metabolic stairs diet and~     circuit-based exercise in a comparison to conventional diet and exercise. The main~     hypothesis is that more significant beneficial metabolic effects will have specific life~     style counseling effect than conventional diet and exercise. The main purpose of this study~     is to assess above mentioned metabolic changes before and after 6-8 weeks of weight loss~     intervention.~      The investigators will also study the following:~        1. The impact of life style counseling induced weight and/or fat loss on physical fitness~        2. The impact of life style counseling induced weight and/or fat loss on metabolic~          parameters (e.g. insulin sensitivity, lipid profile, ect.)~   "
62798|NCT02235272|"~     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)~     compared to vehicle in the treatment of subjects with inflammation and pain following~     cataract surgery.~   "
55873|NCT02325778|"~     This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation~     results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in~     patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic~     drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.~   "
55874|NCT02325765|"~     In this study，the investigators want to determine the corelation between circulating~     nuclearsome and the development of SIRS occured after congenital cardiac surgery, including~     the serverity of organ damage and inflamation.~   "
55875|NCT02325752|"~     The investigators conducted an open randomized control study of patients who received the~     transitional care program versus patients who received usual care at the Singapore General~     Hospital from Aug 2011 to Sept 2012.~   "
55876|NCT02325739|"~     Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401~     as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and~     as single agent in patients with other solid malignancies.~   "
55877|NCT02325726|"~     Postoperative acute renal failure is a frequent complication after cardiac surgery. The~     current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a~     significant kidney assault and prevent an organic dysfunction leading to cortical tubular~     necrosis.~      Several recent studies in cardiac surgery have shown that, both sonographic criteria, such~     as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These~     urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the~     'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought~     noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These~     markers, ultrasonographic and biologic, have the advantage of being easy to perform,~     accessible and seem to have both high sensitivity and specificity to predict AKI promptly~     after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests~     to guide clinicians in determining rapidly whether a patient will develop AKI. However, so~     far, no study has compared these markers yet.~      Therefore, the aim of this prospective observational study will be to compare the~     effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac~     surgery. The secondary outcome will be to determine the threshold of these markers from~     which patients will be likely to develop AKI~   "
55878|NCT02325713|"~     This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The~     purpose of this trial is to assess the relative bio-availability of racemate Oral~     Dispersible Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the~     current marketed praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male~     volunteers.~   "
55879|NCT02325700|"~     This prospective study was designed to analyse the postoperative and long-term outcomes of~     total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive~     disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of~     patients using a propensity analysis model.~   "
55880|NCT02325687|"~     Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative~     complications, including respiratory and cardiac events and delirium. Despite this risk,~     however, there are currently no accepted biomarkers that can predict poor outcomes, making~     it unclear to see which patients will have complications after surgery, and who might need~     prolonged monitoring or an extended hospital stay. An improved understanding of the~     pathophysiology of OSA is required to identify potential biomarkers for outcomes after~     surgery, as well as to develop new treatments. The aim of this pilot study is to identify~     serum and cerebrospinal (CSF) biomarkers associated with obstructive sleep apnea (OSA). The~     presence of cytokines and neurotrophins will be determined and quantified in both patients~     with OSA and in controls. The CSF samples will additionally be analyzed by proteomic methods~     to identify potential biomarkers with significantly different levels present in patients~     with and without OSA. The working hypothesis is that OSA patients who are non-CPAP-compliant~     will have higher levels of circulating cytokines and lower levels of circulating~     neurotrophins in serum and CSF, compared to patients who are CPAP-compliant and/or controls.~   "
55881|NCT02325674|"~     Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated~     with Metreleptin~   "
55882|NCT02325661|"~     The objective of this study is to translate the AKQoL-questionnaire which measures the~     quality of life of patients with actinic keratosis into German and to validate it for the~     Swiss population.~      By using the technique of cognitive interviewing the investigators are focussing on the~     patients' understanding of the questions. The first session of cognitive interviews will~     show, where there is need for improvement in terms of misinterpreted phrases or vaguely~     worded questions. The goal is to rephrase the questions according to the feedback of the~     patients. The revised version will then be presented to a new population.~   "
55883|NCT02325648|"~     The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic~     intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a~     significantly high survival rate has been demonstrated by several studies. It is widely~     known that HIPEC entails severe physiological changes and precautions during anesthesia.~     However, very few studies have systematically outlined and organized these changes for each~     system, and most existing studies only report retrospective data or are limited to~     gynecological surgeries. Therefore, the present researchers planned a prospective~     observational study to determine the physiological changes that occur in patients during~     HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the~     investigators hospital. The investigators planned to monitor the patients' body temperature,~     metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and~     analyze the anesthetic methods applied to identify the optimal anesthetic management~     strategy for HIPEC cytoreductive surgeries.~   "
55884|NCT02325635|"~     Randomized prospective multi-site validation study.~   "
55927|NCT02325063|"~     The primary objective of this study is to compare the evolution of pain profiles among~     patients suffering from lateral epicondyalgia (tennis elbow) following three types of~     treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid~     injection.~   "
55928|NCT02325050|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult~     participants.~   "
55885|NCT02325622|"~     The liver plays a crucial role in physiological glycemic control through its involvement in~     several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver~     diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as~     hepatogenous diabetes. Abnormal glucose metabolism is found in over 90% of patients with~     liver cirrhosis. and clinically significant diabetes is known to occur in 30% to 70% of the~     patients.~      A cohort study of cirrhotic patients with hepatogenous diabetes reported a relatively low~     diabetic complication rate, and the majority of mortality causes were complications related~     to liver cirrhosis; furthermore, mortality rate due to diabetic complications were reported~     to be low. Nonetheless, the average survival rate following the diagnosis of liver cirrhosis~     is rising due to increasing early detection rate and improvements in treatment modalities,~     and such rise in survival is expected to result in increased prevalence of hepatogenous~     diabetes and its complications. Therefore, it is necessary to formulate an accurate~     diagnosis of hepatogenous and to provide appropriate treatment.~      Analyses of the Diabetes Control and Complications Trial (DCCT) demonstrated an association~     between glycated hemoglobin (HbA1c) and mean plasma glucose concentration in diabetic~     patients, and currently, HbA1c is being employed as an appropriate marker in diagnosing~     diabetes mellitus and in monitoring the control of mean blood glucose.~      The association between mean plasma glucose concentration and HbA1c in cirrhotic patients~     has not been clearly established as of yet; however, HbA1c in cirrhotic patients is expected~     to be influenced by various factors resulted by liver cirrhosis and splenomegaly, including~     rapid erythrocyte turnover rate and other glycation processes.~      Therefore, HbA1c may not be an appropriate indicator in the diagnosis of hepatogenous~     diabetes or the monitoring of glycemic control; however, no systemic study on this issue has~     been performed so far. Therefore, the investigators are aiming to investigate the~     association between mean plasma glucose concentration and HbA1c in patients with compensated~     or decompensated liver cirrhosis who also have hepatogenous diabetes.~   "
55886|NCT02325596|"~     This study aimed to evaluate the upstream events of Th17/Treg imbalance in CRS and their~     immune regulatory factors. Then the investigators aimed to explore the regulatory role of~     miRNA on DC-Th axis and its dysfunction in the pathogenesis of CRS, in order to determine~     the miRNA expression profile in CRS and clarify the role of miRNA in the pathogenesis of CRS~     by regulating the DC-Th axis.~   "
55887|NCT02325583|"~     Newborn often sedated during MRI but sedation itself creates adverse events and management~     is more challenging in the MR environment. The investigators describe the investigators~     initial experience with oral 30% glucose administration through a pacifier during MRI for~     imaging of newborns. Using this technique, majority of newborns can complete MRI examination~     without the need for sedation and also offers the availability of administering sedatives to~     unsuccessful patients.~   "
55888|NCT02325570|"~     Multicenter, prospective, interventional open case series study using a randomized~     split-mouth design in moderate to severe chronic periodontitis patients having half-mouth~     treated with the KLOX BioPhotonic OraLum gel with a LED curing lamp as an adjunct to~     conventional non-surgical periodontal treatment (SRP) versus SRP alone in the second~     (control) half-mouth.~   "
55889|NCT02325557|"~     A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a~     combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic~     castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142~     monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in~     combination. Part B expansion will treat additional patients with the recommended dose from~     Part B.~   "
55890|NCT02325544|"~     The study will test the hypothesis that Cognitive Behavioural Therapy plus Standardised~     Medical Care (SMC) will have greater clinical and cost effectiveness than SMC alone in~     treating adult patients with dissociative seizures which had not initially ceased after~     diagnosis.~      About 12-20% of patients who attend neurology or specialist epilepsy clinics because of~     seizures do not in fact have epilepsy. Most of these people have what are referred to as~     dissociative (non-epileptic) seizures (DS). This means that they have episodes that resemble~     epileptic seizures but which have no medical reason for their occurrence and instead are due~     to psychological factors. In younger adults DS are about four times more common in women~     than men. A high percentage of these people will have other psychological or psychiatric~     problems and may have other medically unexplained symptoms. It is generally thought that~     people with DS will benefit from psychological treatments. However, studies on this have~     been small or have not compared the psychological therapy with the treatment people normally~     receive (standardised medical care). There is some evidence that cognitive behavioural~     therapy (CBT), which is a widely accepted talking therapy that focuses on the person's~     thoughts, emotions and behaviour, as well as considering the physical reactions and~     sensations that may occur in people's bodies, may lead to a reduction in how often people~     have DS. The investigators have previously developed a CBT package for people with DS. In a~     relatively small study by our group, published in 2010, people receiving CBT overall showed~     greater reduction in how often they had their DS. The investigators are now conducting a~     larger study, across several different hospitals, to obtain more definite results about the~     effectiveness of our CBT approach for DS.~      The investigators aim to invite ~ 500 adult patients with DS (but without current active~     epilepsy), who have been given their diagnosis by a neurologist or specialist in epilepsy,~     to take part in their study. Up to 698 might be invited if insufficient patients are~     progressing to the RCT.~      The investigators will collect initial information about these people and ask them to keep a~     record of how often they have their DS following diagnosis. Three months after the~     diagnosis, those who have agreed to take part in the study will be seen by a psychiatrist,~     who will undertake a psychiatric assessment and ask them about factors which may have led to~     the development of their DS. Patients who have continued to have DS in the previous 8 weeks~     and who meet other eligibility criteria and are willing to take part in the trial, will be~     randomly allocated to standardised medical care or CBT (plus standardised medical care) as~     further treatment for their seizures. These people will be asked to continue to complete~     seizure diaries and questionnaires, provide regular seizure frequency data following receipt~     of DS diagnosis and will need to be willing to attend weekly/fortnightly sessions if~     allocated to CBT. The investigators initially aim to randomise 298 people (149 to each study~     arm) although now allow for up to 356 to account for loss to follow-up.~   "
55891|NCT02325531|"~     The investigators propose to compare the effectiveness of 3 strategies (low, medium, high~     intensity) at supporting CHCs' implementation of the ALL Initiative (an intervention shown~     to reduce patients' cardiovascular disease (CVD) event risk), through a cluster-randomized~     trial.~   "
55892|NCT02325518|"~     The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT®~     Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular~     hypertension.~   "
55893|NCT02325505|"~     Tuberous Sclerosis Complex (TSC) is a multisystemic autosomal dominant disease that is~     characterized by the development of benign neoplasms in brain, kidney, lung, skin and heart.~     TSC is caused by mutations in TSC1 and/or TSC2 genes, which encode, respectively, hamartin~     and tuberin, that are involved in the regulation of cell proliferation, cell cycle and~     protein synthesis. Most patients exhibit dermatological, renal, neurological and pulmonary~     (lymphangioleiomyomatosis, LAM) manifestations. Neurological involvement include~     subependymal nodules, subependymal giant cell astrocytomas and cortical tubers. LAM is~     characterized by the proliferation of LAM cells around the airways, blood vessels and~     lymphatics, which result in vascular and airway obstruction and cyst formation. The most~     frequent TSC manifestation in the kidney is the development of angiomyolipomas (AML).~     Dermatologic lesions represent the most common manifestations of TSC, mainly hypomelanotic~     macules and facial angiofibromas. The most significant functional implication of the~     tuberin-hamartin complex is its regulatory role upon the mammalian target of rapamycin~     (mTOR) pathway. Mutations in TSC1 or TSC2 lead to increased mTOR activity and favor tumor~     development and growth. All lesions associated with TSC, sporadic LAM and sporadic AML share~     a common molecular pathogenesis, based on TSC1/TSC2 mutations and mTOR hyperactivity. Up to~     date, TSC patients have been followed in separated medical services in our institution,~     according to their predominant phenotype. The current knowledge, however, suggest that the~     ideal follow up of such patients should be conducted in an integrated fashion among the~     specialties associated with the main disease manifestations. Experts in TSC from each of~     these areas have recently created a TSC/LAM/AML integrated program in the University of São~     Paulo Medical Center, and his project will be initiated with the generation of an integrated~     TSC/LAM/AML registry, which intends not only to clinically characterize this patient~     population but also to document the employed treatment modalities. Once this first goal is~     achieved, clinical trials are planned to be performed. The central aim of this observational~     study is to clinically characterize the TSC/LAM/AML subject population followed and referred~     to the University of São Paulo Medical Center. Specific aims: To characterize the pulmonary,~     the neurological, the renal and the dermatologic phenotypes of this patient population.~   "
55894|NCT02325492|"~     This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed~     to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age,~     with newly formed cholesterol gallstones in their gallbladder following bariatric surgery~     confirmed by gallbladder ultrasound ..~   "
55895|NCT02325479|"~     Heparin also has the ability to bind with and modulate a wide variety of proteins, which can~     influence a number of physiological processes involved in implantation & trophoblastic~     development. These processes include adhesion of the blastocyst to the endometrial surface &~     trophoblastic differentiation & invasion.~      A recent Cochrane review hinted towards research to study the possible effects of the local~     (uterine), & NOT SYSTEMIC application of heparin during Assisted reproductive technology~     (ART). Based on the above evidence the investigators hypothesize that low molecular weight~     heparin given intrauterine at mock embryo transfer after oocyte pick up will help improve~     pregnancy rates in patients undergoing ART.~   "
55929|NCT02325037|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to~     healthy subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1837 and its metabolite present in the blood and urine~     (pharmacokinetics) will be characterized.~      The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be~     evaluated.~      The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will~     be explored as well.~   "
55896|NCT02325466|"~     The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be~     superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each~     4 week treatment period. Study participants will be randomized into 3 groups, and each group~     will receive each of 3 treatments in the cross-over study. At the end of each individual 4~     week treatment period the investigators will determine whether there are differences in low~     and high shear rate dependent viscosity and investigate the effect of the treatment on~     peripheral arterial blood flow using pulse volume recordings, ankle brachial index and toe~     pressures. Subjects will be eligible if they have ankle-brachial index less than or equal to~     0.85, or if a patient's blood vessels are calcified, patients will have toe-brachial index~     less than or equal to 0.6 performed using continuous-wave Doppler.~   "
55897|NCT02325453|"~     Gastric cancer represents a great challenge for health care providers and requires a~     multidisciplinary context in which surgery plays a main role.~      Minimally invasive surgery has been progressively developed, first with the advent of~     laparoscopy and more recently with the spread of robotic systems, but a number of issues are~     currently being debated, including the limitations in performing effective extended lymph~     node dissections and, in this context, the real advantages of using the robotic systems, the~     possible role for the Advanced Gastric Cancer, the reproducibility of completely~     intracorporeal techniques and the oncological results achievable during follow-up.~      A multicenter study with a large number of patients is now needed to further investigate the~     safety and efficacy as well as long-term outcomes of robotic surgery, traditional~     laparoscopy and the open approach.~   "
55898|NCT02325440|"~     A trial in patients with relapsing remitting multiple sclerosis (RRMS)~      Main objectives:~        -  To evaluate changes in the reconstitution of immune surveillance over time upon~          switching from natalizumab to fingolimod assessed by a change in the expression of~          CD49d.~        -  To evaluate changes in the migratory capacity of immune cells/peripheral blood~          mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro~          model of the blood-brain-barrier (BBB).~        -  To evaluate changes in paraclinical disease activity over time upon switching from~          natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI).~        -  To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to~          fingolimod.~   "
55899|NCT02325427|"~     This study is to investigate changes in brain activities in acute stroke patients , and to~     correlate findings with clinical outcome measures. Another aim of the study is to~     investigate whether transcranial direct current stimulation (tDCS) could improve motor~     function in subjects with poor brain activity after stroke. The brain activity will be~     measured by single and paired pulse TMS (transcranial magnetic stimulation). The study~     hypothesizes that:~        1. The neural mechanisms employed in patients who have different response to TMS~          stimulation are different. It is hypothesized that patients with no response upon TMS~          stimulation might have poorer motor function outcome, compared with patients with~          response upon TMS stimulation.~        2. The result of clinical outcome measures is related with TMS measurement.~        3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome~          measures will include a battery of upper limb motor tests such as upper extremity~          component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and~          block test, and manual muscle testing. Clinical outcome and TMS measurement will be~          assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.~   "
55900|NCT02325414|"~     The overall objective of this study is to define an effective therapeutic approach, using~     currently available medication, to prevent or mitigate the loss of bone mass and bone~     strength that occurs after acute spinal cord injury.~   "
55901|NCT02325401|"~     The purpose of this research study is to test the safety of adding metformin to standard of~     care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments~     and radiation for 7 weeks.~      Metformin is a medication that is currently used to treat diabetes. Increasing amounts of~     metformin will be given to groups of patients already receiving normal treatment for their~     cancer to see if metformin causes any good effects by killing your cancer or bad effects~     (side effects).~   "
55902|NCT02325388|"~     Pressure ulcers are prevalent conditions that result in substantial financial costs to the~     healthcare system as well as significant distress to affected patients and their families.~     This study is a parallel two-group randomized controlled trial that aims to study how the~     use of a pressure sensing device with continuous visual feedback of pressure imaging may~     potentially decrease the interface pressure of patients who are at risk of pressure ulcers~     in an acute hospital setting.~   "
55903|NCT02325375|"~     Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive muscle weakness~     leading to severe disability and eventually death.Since the diagnosis relies on clinical~     features and electromyographic abnormalities, which may occur rather late in the disease~     course, there is a need to identify diagnostic tests that can confirm or exclude the~     diagnosis of ALS in the earlier phase of the disease.~      More recently, there are studies suggesting neuroinflammation to play a role for the~     development of ALS. Cluster of differentiation 163 is found to be up regulated in a large~     range of inflammatory diseases.~      At the investigators lab, pilot data (Kallestrup M et al, unpublished data) has shown~     promising results. There was an increased level of cluster of differentiation 163 (sCD163)~     in cerebrospinal fluid in 7 patients with ALS compared with controls.~      The purpose of the investigators study is to define the concentration of sCD163 in the~     cerebrospinal fluid and serum in patients with ALS compared with controls (patients with~     unspecified neurological symptoms). Furthermore, the investigators will define the~     concentrations of protein, glucose, immunoglobulin G index and other factors in the spinal~     fluid.~   "
55904|NCT02325362|"~     The purpose of this study is to demonstrate that Miglustat restores the function of the~     cystic fibrosis transmembrane conductance regulator (CFTR) in adult patients with cystic~     fibrosis homozygous for the F508del mutation.~   "
55905|NCT02325349|"~     The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand~     in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent~     with antiangiogenic effect.~      The predictive value of this approach will be determined by independent assessors on basis~     of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for~     FDG PET/CT, clinical, endoscopic and histological findings.~   "
55906|NCT02325336|"~     Serious medication administration errors are common in hospitals. Various interventions were~     developed to help prevention of such errors such as bar-code technology. Investigators aimed~     to study the effect of bar-code-assisted medication administration (BCMA) system on the rate~     of medication errors in two hospitals.~      They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris,~     France. Each unit will be randomized in either the control group or the intervention group~     using the bar-code system to help drug administration. The observation method will be used~     to evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted.~     Nurses of the unit will be randomized to determine who will be observed during the~     administration rounds.~      Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv~     Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators~     estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative~     reduction of 45% of error rate.~   "
55907|NCT02325323|"~     This prospective cohort study aims to assess the incidence of gastric cancer in patients~     with intestinal metaplasia in body of stomach or angular incisure.~      As secondary objectives, among the patients included in the cohort, the study will:~        -  assess the incidence of low grade dysplasia,~        -  assess the incidence of high grade dysplasia in patients with low grade dysplasia,~        -  identify risk factors of progression to dysplasia and gastric cancer.~   "
55908|NCT02325310|"~     In order to assess the safety of breastfed infants after their mother's postpartum~     immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study~     is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding~     women with negative rubella and measles serologies.~   "
55909|NCT02325297|"~     After the death of a patient in the hyper-technical context of intensive care, his relatives~     are particularly vulnerable and often exhibit symptoms of anxiety, depression, post~     traumatic stress and complicated grief. The first results of a qualitative study Famiréa~     current (CAESAR) support the idea that the bereaved relatives suffer from persistent~     misunderstandings and a feeling of abandonment of the resuscitation team. Many families~     suggest the need for contact with the team after the patient's death. The letter of~     condolence received by some families allowed them to feel recognized in their pain~     resuscitation teams. This has led us to ask the question of post-death monitoring and~     interest to send to bereaved relatives a letter of condolence, as recommended by the~     American consensus conference in 2004 on good palliative care. This strategy would allow the~     recognition of both close to the pain but also the strong bond that united the resuscitation~     team. The hypothesis of the study is that the post-death followed in the form of a letter of~     condolence sent by the intensive care physician who was in charge of the patient, could~     reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and~     reduce the rate of complicated grief.~      Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who~     did not receive a letter of condolence and a group that received a letter of condolence 15~     days after the death.~   "
55910|NCT02325284|"~     The development of tools for assessment and management of pain in newborns and children is a~     high priority and represents a significant unmet need. The inadequate treatment of pain and~     the overuse of analgesics can cause harmful consequences for neonates, infants, and~     children. To accomplish successful pain management in children one must first objectively~     assess pain. Thus, to address these critical issues with pain management, the Human~     Algometer and methods are under development by Drs. Julia Finkel and Zena Quezado, Pain~     Medicine Program (SZI) at Children's National Medical Center.~   "
55911|NCT02325271|"~     The study evaluates the intra-individual variability of VEGF levels over a period of 6~     months as well as the circadian variation of VEGF levels, both under standardized conditions~     in patients with type 2 diabetes without DME and matched subjects with normal glucose~     tolerance (NGT). Secondary objectives of the study are to evaluate the relationship of~     individual VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk~     factors.~   "
55912|NCT02325258|"~     The aim of the present study was to evaluate the ability of health-care professionals in~     addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the~     clinical microbiology department, from a clinical microbiologist, in the early management of~     sepsis.~   "
55913|NCT02325245|"~     The purpose of this study is to investigate the effects of metformin to prevent frailty in~     pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status,~     quality of life, handgrip strength, gait speed, and serum myostatin levels.~      We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.~   "
55914|NCT02325232|"~     Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries~     with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a~     benign course with clinical and histological remission, provided that a strict gluten-free~     diet (GFD) is followed by patients. Less frequently, CD can be characterized by a~     complicated course, when facing with a refractory disease (RCD) or with malignancies of the~     gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB).~     Different studies estimated a relative risk (RR) for neoplastic GI complications in CD~     ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma,~     respectively. Although uncommon, the discussed malignancies has a severe prognosis,~     reflecting the need for an early diagnosis. This project aims to establish an enteroscopic~     approach to improve the diagnostic timing and survival of CD patients at risk to develop SB~     tumors.~   "
55915|NCT02325219|"~     The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to~     placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A~     common genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches).~   "
55930|NCT02325024|"~     The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of~     Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when~     subjects have severe renal impairment or end stage renal disease (ESRD), compared with~     subjects who have normal renal function.~      The primary clinical hypothesis is that there will be an effect from severe renal impairment~     on the PK of Sativex® when administered as a single oromucosal dose.~      The study additionally aims to evaluate the safety and tolerability of the same single~     oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.~   "
55916|NCT02325206|"~     Dapagliflozin has been effective at lowering glucose and hemoglobin A1c (HbA1C) in subjects~     with tpye 2 diabetes (T2DM), when studied as monotherapy as well as in combination with~     insulin or oral anti-diabetic medications.This lead to investigations if this therapy would~     also be of benefit in type 1 diabetes as intensive insulin therapy is associated with~     glucose fluctuations, hypoglycemia, weight gain, and subsequent insulin resistance, all of~     which may reduce efficacy.~      The purpose of the pilot study is to collect clinical data on the HbA1c-dependent effect of~     a single-dose of 10mg dapagliflozin on the insulin dose administered intravenously during a~     glucose-infusion and an oral mixed-meal for the ensuing 24 hours with blood glucose kept~     between 160 - 220 mg/dl.~      The first objective is to investigate the degree of insulin dose reduction 24 hours after a~     single dose of 10mg dapagliflozin in patients with type 1 diabetes Further objectives are to~     investigate~        -  the effect on urinary glucose excretion~        -  if this effect is influenced by baseline glycemic control~        -  if dapagliflozin influences postprandial insulin need~        -  if dapagliflozin is associated with elevated ß-hydroxybutyrate levels~        -  PK after oral administration of 10mg dapagliflozin~   "
55917|NCT02325193|"~     The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for~     continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the~     continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also~     interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO,~     the interruption takes place at a settled threshold level. In difference in the new system~     MM640G the shutdown algorithm can already be proactive and help avoid hypoglycemia~     completely. The so called PLGM algorithm (predictive low glucose management) should be~     tested in the user evaluation. The main objective is to answer the question of reducing the~     rate of hypoglycemia by application of the new PLGM algorithm.~      Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.~   "
55918|NCT02325180|"~     This is a prospective, open label, randomised controlled trial to assess the safety and~     efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and~     adults with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for~     antimalarial resistance will also be assessed and the presence of molecular markers in the~     parasites will be associated with treatment outcomes.~   "
55919|NCT02325167|"~     The purpose of the study is to test the effectiveness of a short-term manualised individual~     psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in~     informal caregivers of palliative patients.~   "
55920|NCT02325154|"~     We plan to investigate the relationship between hypotensive epidural anesthesia for hip~     arthroplasty and cerebral oxygen saturation.~   "
55921|NCT02325141|"~     Leakage is the most common complication after laparoscopic sleeve gastrectomy which may~     amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A~     (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of~     postoperative gastric leakage.~   "
55922|NCT02325128|"~     Investigators will examine whether post-exposure naps can be used to strengthen therapeutic~     extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two~     individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the~     Liebowitz Social Anxiety Scale, by self-report during a clinical interview and by~     demonstrated enhanced psychophysiological reactivity when imagining a socially stressful~     scenario, will be enrolled as one of four participants in one of eight successive offerings~     of a validated 5-session exposure-based group treatment for extreme social anxiety. The~     third and fourth sessions conclude with each participant delivering a speech on a topic~     individually chosen to elicit significant social anxiety. Following these sessions,~     participants will go to the sleep laboratory where two will be given a 2-hour sleep~     opportunity with polysomnographic (PSG) monitoring and two will be similarly instrumented~     but undergo 2 hours of monitored quiet wakefulness. Before and after treatment, participants~     will be individually assessed for social anxiety symptoms using standardized self-report~     instruments and a Trier Social Stress Test (TSST) modified for continuous~     psychophysiological monitoring. Ambulatory monitoring of home sleep will also be obtained~     using actigraphy and sleep diaries. The investigators hypothesize that, post treatment,~     those individuals who napped will show greater questionnaire-based clinical improvement as~     well as lesser psychophysiological reactivity during the modified TSST compared to those who~     remained quietly awake. The investigators further hypothesize that characteristics of sleep~     quality and architecture during naps, specifically durations of total sleep, REM and~     slow-wave sleep, as well as REM continuity, will predict greater clinical improvement and~     lesser psychophysiological reactivity to the TSST in those who napped following their third~     and fourth therapy sessions. Positive results will provide the first proof-of-principle for~     sleep augmentation of exposure therapy for clinically significant extreme social anxiety.~   "
55923|NCT02325115|"~     Background: Despite current popularity, positive mental health is under researched. This is~     possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental~     Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to~     measure mental well-being. Its validation has been internationally explored. This report~     presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical~     populations.~      Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75~     students (STUD), and one clinical population of 121 patients with remitted schizophrenia~     (PRS) were included in the validation study. Participants completed the F-WEMWBS as well as~     complementary measures of psychological constructs potentially related to well-being.~   "
55924|NCT02325102|"~     Co-occurence of multiple pathogens in children is a known phenomenon, however the potential~     effect on the probability to develop a disease and on its severity, as well as the~     relationships between them, has not been studied adequately.~      In this study, children admitted to the pediatric department with a clinical presentation of~     an infectious disease were tested for the presence of multiple pathogens. Data about their~     clinical status and about the accessory examinations performed during hospitalization were~     collected and analyzed.~   "
55925|NCT02325089|"~     Sleep apnea involves significant increases in disease and death, but its consequences in~     people over 65 years of age are incompletely recognized. Intraoral mandibular advancement~     appliances reduce the number of apneas and hypopneas. The investigators hypothesized that~     oral appliances provided to the elderly may prevent hypertension and other consequences of~     sleep apnea in large populations, at a favorable cost/benefit relationship for the public~     health system.~   "
55926|NCT02325076|"~     The airflow moving from mouth to the lungs, which can be measured by pulmonary function~     tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can~     be considered as the anatomic disorder of the upper airway as well. Therefore, there can be~     a relationship between difficult airway and pulmonary function tests. The purpose of this~     study is to elucidate the association between the pulmonary function tests and difficult~     airway.~   "
95648|NCT01805180|"~     The purpose of this study is to compare the procedures for the collection PMN cells on~     Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.~   "
55931|NCT02325011|"~     The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of~     a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises~     and excretes the drug) in healthy subjects with a history of cannabis use.~      The primary clinical hypothesis is that no drug-drug interaction between Sativex® and~     fluconazole will be detected as effects on PK parameters of Sativex®, when both are~     administered to healthy human volunteers who have experience using cannabis.~      The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of~     Sativex® in subjects when given concurrently with fluconazole.~   "
55932|NCT02324998|"~     Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there~     remains an unmet medical need to identify and optimise additional treatment for those~     patients with early prostate cancer who are at greatest risk of relapse following first-line~     treatment with curative intent.~      This is a phase I study investigating the feasibility and tolerability of a short course of~     neoadjuvant treatment with olaparib, either as a monotherapy or in combination with~     degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with~     early, localised intermediate-/high- risk prostate cancer. Our primary objective is to~     determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this~     patient population.~      Participants will receive either single agent olaparib or olaparib in combination with~     degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We~     will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP~     inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at~     baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will~     permit us to examine biomarker variability between the samples.~      The incidence and severity of Adverse Events will be documented and we will assess the~     number of trial participants who undergo surgery on schedule. We will assess preliminary~     evidence of tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA).~     We also intend to investigate changes to the ctDNA profile by comparing blood samples~     collected throughout the study.~   "
55933|NCT02324985|"~     This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302)~     applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed~     onset muscle soreness.~   "
55934|NCT02324972|"~     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo on change from baseline in Target~     Lesion Symptom Score in subjects with mild to moderate atopic dermatitis~   "
55935|NCT02324959|"~     The purpose of this study is to determine whether acupuncture and computer-based attention~     training can be combined for more effective post-stroke attentional deficits.~   "
55936|NCT02324946|"~     The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep~     Apnea.~      This study will compare, among patients scheduled for bariatric surgery, these two scores as~     predictive scores for a difficult intubation.~   "
55937|NCT02324933|"~     This study will evaluate the value of dosing pain medications based upon a patient's~     pre-operative tolerance to pain medications. Study participants will be assigned to one of~     two groups, a treatment group and a control group. The treatment group will be given pain~     medications after surgery based upon their measured response to pain medications prior to~     surgery. The control group will be given pain medications based upon the normal dosing~     routine as is currently practiced. Both groups will be closely monitored for side effects~     and have their pain scores recorded for the first 48 hours following surgery.~   "
55938|NCT02324920|"~     The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition~     to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is~     that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or~     partially by transforming syncope in pre-syncope.~   "
55939|NCT02324907|"~     The purpose of this study is to determine the clinical efficacy of a novel dynamic~     compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.~   "
55940|NCT02324894|"~     Mammography remains an imperfect screening test especially in women with extremely dense~     breast tissue, missing biologically aggressive cancers especially in younger population and~     picking up indolent cancers that do not need treatment.~      The most sensitive test for breast cancer detection at our disposal is magnetic resonance~     imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST~     Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and~     specificity values.~      Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer~     screening: it is safe, does not induce cancers, and can find more cancers than mammography.~      However this study was performed in women with low to moderately increased risk.The value of~     FAST Breast Magnetic Resonance in normal screening population has to be assessed before a~     modification of current strategy of breast cancer screening with mammography.~   "
55941|NCT02324881|"~     This pilot clinical trial studies a pain management smartphone application for monitoring~     pain in patients with locally advanced head and neck cancer who are undergoing radiation~     therapy. The study is also open to patients with esophageal or lung cancer. A smartphone~     application may allow patients to assess their symptoms in a manner that is closer to~     real-time than having to recall pain episodes during once weekly on-treatment visits with a~     health care provider. This real-time monitoring may improve the timing and efficacy of~     interventions leading to better pain-control and quality of life.~   "
55942|NCT02324868|"~     Venous catheters are necessary for the treatment of many patients. Showering with a venous~     catheter is often prohibited due to the infection risk when the insertion site becomes wet.~     Therefore these patients are challenged to keep the catheter insertion site dry and always~     covered with a dressing. Washing themselves is often impossible without assistance of a~     nurse or significant other. For patients with a catheter connected to an infusion line, it~     is even more difficult. Showerpatch is a newly developed dressing that safeguards the~     insertion site of an IV catheter from water during bathing activities. The purpose of this~     trial is to evaluate the impact of the availability of Showerpatch by comparing the outcomes~     in patients regarding the patient's autonomy in bathing activities, the material use and the~     time needed from caregivers in home care. Additionally qualitative data on patient's bathing~     activities and the use of Showerpatch will be collected.~   "
55943|NCT02324855|"~     The main aim is to analyze whether the routine use of chest physiotherapy in non cystic~     fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this~     population. In addition, the secondary end-points include incidences of exacerbations,~     changes in lung function, exercise capacity, airways inflammation, sputum analysis and~     eventual adverse events.~   "
55944|NCT02324842|"~     Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can~     prevent the increase in HGP following institution of canagliflozin therapy and produce an~     additive or even synergistic effect to lower the plasma glucose concentration and A1c.~      Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin~     can produce an additive, or even synergistic, effect to promote weight loss and reduction in~     hepatic and visceral fat content.~      Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin~     can produce an additive or even synergistic effect to reduce systolic/diastolic blood~     pressure and 24-hour integrated blood pressure.~   "
55945|NCT02324829|"~     Physiotherapists spend a large amount of their time with patients observing their~     rehabilitation techniques. A patient going through rehabilitation exercises are routine and~     does not necessarily require the attention of the physiotherapist. This research will~     develop a sensor system that will be strapped onto the patients and will provide feedback on~     how accurately the exercise is being executed. This will free up the physiotherapist to~     focus on diagnosis and other tasks that will better utilize the physiotherapist's training.~     A previous study has shown that this system is feasible for healthy subjects. This study~     would test to see if this system is extendable to rehabilitation subjects.~   "
55946|NCT02324816|"~     Evaluate the performance of a cryolipolysis system using a colder treatment parameter for~     non-invasive reduction of subcutaneous fat in the lateral thighs.~   "
55947|NCT02324803|"~     assess the activity and toxicity of second-line treatment with pazopanib after failure of~     first-line sunitinib treatment in patients with clear cell mRCC; to investigate the~     potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical~     response to pazopanib in mRCC patients.~   "
55948|NCT02324790|"~     This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep~     Therapy System for the treatment of obstructive sleep apnea.~   "
55949|NCT02324777|"~     Primary Objective:~      - To determine the analgesic dose-response characteristics of vapourized cannabinoids with~     varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios.~      Secondary Objectives:~        -  To compare functional changes and patient preferences of different cannabinoid (THC,~          CBD) profiles in patients with OA (Osteoarthritis);~        -  To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid~          profiles in patients with OA;~        -  To explore the short term safety of vapourized cannabis with different cannabinoid~          profiles.~        -  To describe the incidence and severity of psychoactive events.~   "
55950|NCT02324764|"~     The objective of this study is to determine the rate of radial artery occlusion and vascular~     access site complications following transradial angiogram using a new Terumo (Tokyo, Japan)~     Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.~   "
55951|NCT02324751|"~     Using an established model of human typhoid infection, whereby healthy adults are~     deliberately exposed to typhoid-causing bacteria, the investigators will determine how~     effective a new typhoid conjugate vaccine (Vi-TCV) is in preventing infection. The new~     typhoid vaccine will be compared with a control vaccine (meningococcal ACWY). The protective~     effect of a currently used typhoid polysaccharide vaccine (Vi-PS) will also be studied and~     compared with the control vaccine using this model of typhoid infection.~      A second component of this study will involve vaccinating 15-20 participants with Vi-PS.~     Serum will be obtained prior to vaccination and 4-6 weeks after vaccination. The~     post-vaccination serum will be pooled and used to create an anti-Vi IgG serum standard.~   "
55952|NCT02324738|"~     This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate~     dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol~     university.~      The 16 subjects have already participated in a healthy volunteer studies in the past either~     i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered~     primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii)~     Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of~     chloroquine and piperaquine in healthy Thai subjects~      Every subject was administered a single dose of three tablets of DHA-PQP from previous~     studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results~     of DHA-PQP arm from these previous studies and ask the healthy subjects to participate this~     study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet~     of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on~     second admission.~   "
55953|NCT02324725|"~     This study evaluates the biological markers of treatment of opioid dependent individuals~     with an extended release formulation of the opioid antagonist naltrexone. The biological~     measures include functional MRI, blood levels of naltrexone and its metabolites, urine~     toxicology and behavioral tests probing various aspects of personality, memory, reward~     processing and attention.~   "
55954|NCT02324712|"~     Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines~     and growth factors in the circulating blood (and cytokine levels only in saliva) of patients~     with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine~     differences in cytokine profiles between real and sham acupuncture in circulating blood of~     patients with chronic TMD; and 3) To explore correlations between these changes and clinical~     outcomes.~      Participants: Patients with chronic TMD pain recruited through the University of North~     Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.~      Procedures (methods): Participants will complete a self-administered questionnaire assessing~     TMD-related comorbidity. During the initial visit, study examiners will record clinical~     characteristics of muscles and joints of the head, neck and body according to newly~     recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index~     (computed from numeric rating scales) of masseter, temporalis and the supplemental painful~     muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile;~     MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and~     after acupuncture treatments. Participants will self-collect pre-treatment and~     post-treatment saliva samples. Patients will receive 4 acupuncture treatments, once per week~     for 4 weeks. The primary outcome measure is change in IL-8 levels in circulating blood and~     saliva after 4 weeks of real acupuncture compared with sham acupuncture. Secondary outcome~     measures include comparing changes in levels of nerve growth factor (NGF), tumor necrosis~     factor-alpha (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth~     factor (PDGF), basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10,~     before and after real acupuncture at Week 1 compared with sham acupuncture and before and~     after real acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome~     measure is correlation between changes in cytokine levels and clinical variables after 4~     weeks of real acupuncture compared with 4 weeks of sham acupuncture.~   "
55956|NCT02324686|"~     The purpose of this study is to determine whether vitamin K supplementation will improve~     anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation.~     Patients who participate will receive vitamin K1 three times a week on dialysis days for a~     period of four months. INR levels collected during this period will be compared to the four~     month period prior to receiving the vitamin K1 to determine if vitamin K improves the~     standard deviation of INRs and time in therapeutic range.~   "
55957|NCT02324673|"~     This is a Phase 1/2, open-label, trial designed to assess the pharmacokinetics, safety,~     tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral~     Solution in a sequential fashion.~      Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant~     seizures, and satisfy all inclusion/exclusion criteria.~   "
55958|NCT02324660|"~     Several studies and registries suggested that the concomitant presence of acute coronary~     syndromes (ACS) and chronic obstructive pulmonary disease (COPD) is significantly associated~     with poor prognosis. It has been suggested that diagnosis of COPD is frequently missing.~     Thus, it is plausible that a significant percentage of patients with ACS may have~     unrecognized COPD. This missing diagnosis may contribute significantly to poor prognosis.~     The investigators suppose that the concomitant use of peak expiratory flow (PEF) measurement~     and of Respiratory Health Screening Questionnaire (RHSQ, adapted version) could be useful as~     screening test for COPD in patient smokers or former smokers admitted to hospital with a~     diagnosis of ACS. In all screened patients COPD diagnosis will be confirmed (or not) two~     months after hospital discharge with spirometry. In the same setting of patients, the~     investigators will characterize the underlying pathological mechanisms, evaluating several~     inflammation, platelet and endothelial markers.~   "
55959|NCT02324647|"~     Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical~     biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the~     presence of hormonal hypersecretion or adrenocortical carcinoma (ACC), respectively. The~     overall aim of this study is to improve the cost-effectiveness of the diagnostic strategy~     for AI. Cost-effectiveness of urine steroid profiling (USP) will be compared to the standard~     diagnostic strategy of repeated CT-imaging.~   "
55960|NCT02324634|"~     Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand~     function, muscle weakness, pain, and joint deformities are persistent and disabling problems~     for nearly half of all stroke survivors. This can, in part, result from patients not getting~     adequate therapy targeting the hand and arm in the very early stages of rehabilitation.~     Previous research has highlighted the importance of early rehabilitation interventions after~     stroke. Although in stroke patients the damage is to the brain rather than the limbs, muscle~     wastage (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur~     in those who have retained some degree of active arm movement. Electrical stimulation (ES)~     is a painless treatment in which small pulses of electrical current from a battery operated~     portable device are used to activate a paralysed muscle and produce a strong muscle~     contraction. ES has been shown to increase brain activity and can hence influence the~     formation of new nerve pathways (known as neuroplasticity) to replace those damaged by~     stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of~     the forearm improved the chance of a person recovering arm function. However, as the~     intensity of treatment was not sufficient to prevent the complications identified in this~     proposal, the impact of any functional benefit was significantly limited. We plan to build~     on previous research by training clinical therapists to operate ES devices; starting ES much~     earlier after stroke; applying a higher intensity treatment to more of the forearm muscles~     (i.e. both the front and back of the forearm) and providing treatment for a longer period of~     time than previously carried out. We will evaluate the feasibility of incorporating ES into~     a patient self-management programme to enable independent use outside of routine therapist~     led rehabilitation sessions.~   "
55961|NCT02324621|"~     This phase I trial studies the long-term side effects of the continuation of oral ONC201 in~     treating patients with solid tumors that have spread to other places in the body who have~     previously benefited from receiving this drug. Oral ONC201 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
55962|NCT02324608|"~     This pilot clinical trial studies the side effects and how well cetuximab before surgery~     works in treating patients with skin cancer that forms, grows, and spreads quickly and has~     spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as~     cetuximab, may block tumor growth in different ways be targeting certain cells. Giving~     cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
55963|NCT02324595|"~     Phase II multicentric study~   "
55964|NCT02324582|"~     This is a single center Phase I safety and efficacy study of MK-3475 therapy used in~     combination with bladder infused BCG treatment for patients, 18 years or older, with high~     risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall)~     who have had removal of their bladder tumor. Patients will be enrolled to a single treatment~     group of a fixed dose of MK 3475 and BCG.~   "
55965|NCT02324569|"~     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when~     administered at a dose of 100 mg once weekly as an add-on to insulin therapy (SYR-472 100 mg~     combination/SYR-472 100 mg combination group) using insulin preparation alone/ SYR-472 100~     mg combination group as a control in patients with type 2 diabetes mellitus and inadequate~     glycemic control despite treatment with insulin preparations in addition to diet and/or~     exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when~     administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients~     with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin~     preparations in addition to diet and/or exercise therapy.~   "
55966|NCT02324556|"~     All patients planned for an anterior resection due to rectal cancer with a total mesorectal~     excision are included. This is a feasibility study, thus no randomization will be performed.~      Primary endpoint is clinical and pathologic examination of the specimen. Secondary~     end-points include clinical variables such as conversion rate, re-admission and/or~     re-operation due to any complication and health economy analyses.~   "
55967|NCT02324543|"~     This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination~     with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with~     metastatic pancreatic cancer.~   "
55995|NCT02324179|"~     Our objective is to determine whether HIV infected youth have higher level of endothelial~     dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched~     healthy controls. The investigators also aim to gather preliminary data on whether~     endothelial Peripheral Arterial Tonometry (endoPAT) measurements of endothelial dysfunction~     are independently associated with HIV and antiretroviral factors, and with markers of~     inflammation and traditional cardiovascular disease risk.~   "
55968|NCT02324530|"~     This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm~     motion, heart position and tumor motion compared to free breathing. Only patients with~     significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry~     (heart close to chest wall) identified on standard imaging and simulation will be candidates~     for the study. Patients will be re- simulated and planned for radiation treatments with~     CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the~     impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as~     the heart and lung.~   "
55969|NCT02324517|"~     Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other~     severe bleeding disorders could be monitored and guided based upon special clotting assays ,~     eg thrombin generation and thromboelastography. In this study blood sampled from patients~     with bleeding disorders will be evaluated applying ex- vivo spiking assays with various~     coagulation concentrates to potentially address the feasibility of replacement /bypass~     agents/ combined therapy for future bleeding episodes. Patients that will be further treated~     by any regimen potentially suggested (as standard care- not within trial) will be thereafter~     followed , including repeated lab studies to assess the impact of therapy upon hemostasis.~   "
55970|NCT02324504|"~     This study will enroll up to 192 children less than 18 years of age, who will receive~     electrocardiographic guidance for placement of a PICC in addition to radiography done as~     standard care. The investigators will determine the location of the PICC tip from both ECG~     and radiograph, and then measure the degree of correlation between the two methods.~   "
55971|NCT02324491|"~     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese~     adult subjects with type 2 diabetes mellitus.~   "
55972|NCT02324478|"~     The autonomic nervous system state (ANSS) and the autonomic nervous system state index~     (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been~     recently advocated as a measure of sympathetic activity in the anesthetized patients, but~     their validity has not been yet demonstrated. We will conduct a study aiming to assess if~     ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in~     healthy humans under general anaesthesia.~   "
55973|NCT02324465|"~     The investigators plan to conduct a randomized trial comparing the intubation success rate~     and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order~     to demonstrate the comparability of the devices.~   "
55974|NCT02324452|"~     In this study it will be determined whether the rate of severe toxicity associated with~     fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished~     by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of~     dihydropyrimidine dehydrogenase (DPD) deficiency.~      In addition to the genotyping, the DPD phenotype of all patients will be determined by~     measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether~     phenotype-guided treatment can further improve patient safety. In a subgroup of patients,~     other phenotyping methods will be tested: measuring the plasma levels of uracil after a~     uracil test dose and a uracil breath test after a dose of [2-13C] -labeled uracil. To~     validate these tests, these phenotyping results will be compared with the results of a DPD~     activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells),~     which is considered the gold standard in measuring DPD phenotype.~   "
55975|NCT02324439|"~     This is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed~     supplementation is an effective maintenance therapy for patients with ovarian cancer who are~     in clinical remission following platinum-based regimens. The investigators further~     hypothesize levels of estrogen metabolites and prostaglandin E2 in this patient population~     will correlate with recurrence of disease, extent of tumor burden, invasion and metastasis.~   "
55976|NCT02324426|"~     Excessive free radical formation and depletion of the brain's primary antioxidant,~     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While~     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some~     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement,~     obstacles surrounding currently employed delivery methods have hindered the clinical utility~     of this therapy. Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation. The~     aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in~     brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15~     individuals with PD.~   "
55977|NCT02324413|"~     Children who are upset during induction of general anaesthesia are frequently distressed~     postoperatively and are more likely to demonstrate negative behaviour changes.~      This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia~     to identify whether postoperative behavioural disturbance may be minimised.~   "
55978|NCT02324400|"~     The study is intended to verify the safety and assess the performance of up to 3-days~     treatment protocol with the RenaSense System in ADHF patients.~   "
55979|NCT02324387|"~     The goal of this clinical research study is to compare Tc99m sestamibi molecular breast~     imaging (MBI) scans to mammograms and ultrasounds (the current standard of care) to learn if~     MBI scans can measure if the disease is responding to chemotherapy.~   "
55980|NCT02324374|"~     This will be a pilot study to evaluate the role of endocytoscopy in classifying colorectal~     polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image~     features of neoplastic and non-neoplastic colorectal polyps. The target population will~     include adult subjects undergoing screening and surveillance colonoscopies.~   "
55994|NCT02324192|"~     Objective: To evaluate the correlation / association between inflammatory ultrasonography~     findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints~     (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings.~      Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were~     assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by blind observers (clinical and~     ultrasonography). The intra and interobserver reproducibility analysis was performed in 25%~     of the sample. Differences were considered as statistically significant when p< 0.05.~   "
56011|NCT02323971|"~     Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the~     treatment of the prevention of the thrombotic events in patients with coronary artery~     disease (CAD), showing a reduction in adverse events.~   "
55981|NCT02324361|"~     To date, approaches that show the most promise for preventing and/or reversing the course of~     childhood obesity involve the delivery of intensive lifestyle interventions within a~     family-based context, emphasizing the necessity of parental involvement and making changes~     in family routines and the home environment. Considering that the current demand for~     pediatric weight management programs far exceed availability, as well as the high attrition~     rates observed in such programs, there is a great need for more accessible and efficient~     means of delivering these interventions to reduce the burden of childhood obesity.~      The goal of this study is to understand whether text messaging and social media platforms~     can be leveraged to address the important issue of childhood obesity by engaging~     parent/guardians in one of these strategies, and whether these strategies produce similar~     outcomes. No existing study has compared these strategies head-to-head, and the~     investigators believe that this project will be instrumental in understanding the~     determinants of success in these strategies and allow us to collect sufficient intelligence~     to be able to deploy these meaningfully to patients as part of usual care.~   "
55982|NCT02324348|"~     It is known that no reflow phenomenon by microvascular obstruction after revascularization~     in STEMI increase infarct size, cardiac remodeling, and a risk of late mortality. Major~     mechanism of microvascular obstruction is distal embolization during procedure. Some~     investigators showed deferred stenting decreased the degree of microvascular obstruction~     compared with immediate stenting in STEMI. The aim of current study is to compare impact of~     immediate stent implantation versus deferred stent implantation on infarct size and~     microvascular perfusion in patients with ST-segment elevation myocardial infarction (STEMI).~   "
55983|NCT02324335|"~     Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or~     radiation regimens used to treat cancer. This study examines the investigational drug~     brilacidin and its possible application in prevention of oral mucositis in patients~     undergoing chemoradiation for treatment of head and neck cancer.~   "
55984|NCT02324322|"~     The purpose of this research study is to evaluate an exoskeleton device and mobility skills~     in the device.~   "
55985|NCT02324309|"~     The study is designed to compare meal time glucose control associated with BIOD-531, a~     rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin~     R U-500 in patients with diabetes and severe insulin resistance.~   "
55986|NCT02324296|"~     ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer~     (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years~     , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average~     median survival of about 7-8 months in patients with extended disease (ED).~      In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant~     advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and~     Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used~     regimen in SCLC.~      Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16~     females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2,~     Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.~      Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per~     patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients~     (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).~   "
55987|NCT02324283|"~     Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and~     recovery time, and perioperative oxygenation in lung resection surgery?~   "
55988|NCT02324270|"~     To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against~     Flector patch in the treatment of pain in subjects with minor ankle sprain~   "
55989|NCT02324257|"~     This study is a first-in-human, open-label, multi-center, dose-escalation Phase 1 clinical~     study of single-agent RO6958688 in patients with locally advanced and/or metastatic~     CEA-positive solid tumors who have progressed on standard treatment, are intolerant to~     standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two~     parts. Part 1 will investigate the safety and pharmacokinetics of a single dose of RO6958688~     in single patient cohorts. Part 2 will establish the appropriate therapeutic dose(s) based~     on safety, pharmacokinetics, and the maximum tolerated dose of RO6958688 for the weekly~     schedule. The anticipated time on treatment is a maximum of 24 months. The overall target~     sample size is 90.~   "
55990|NCT02324244|"~     Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a~     broad cohort of consecutive immunocompetent adults admitted to a major heart surgery~     intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors,~     and clinical significance of CMV infection.~   "
55991|NCT02324231|"~     In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover~     non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer~     requiring chemotherapy, primarily the safety, and secondarily the efficacy and other~     endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF)~     for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is~     assessed by the rate of safety relevant events per chemotherapy exposure time, a composite~     endpoint including serious medical complications and bacteremia during FN. Patients are~     repeatedly randomized (cluster: study site) to the high or the low TLDF every month,~     resulting in possible multiple crossovers in one patient. The high TLDF is declared not to~     be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio~     of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33,~     applying mixed Poisson regression.~   "
55992|NCT02324218|"~     This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among~     diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large~     population-based cohort in United Kingdom (UK) using data from the CPRD database.~   "
55993|NCT02324205|"~     The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both~     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with~     other subject data including histology results from biopsy specimen examination and cancer~     classification data from initially asymptomatic women referred for biopsy after recall from~     screening and diagnostic work-up. These data will be included in a subsequent and~     prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining~     superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance~     measures.~   "
55996|NCT02324166|"~     In retinal surgery, endophthalmitis is a sight-threatening eye infection that could~     complicate patient vision after the operation. At Toronto Western Hospital, for retinal~     surgery (operating at the back of the eye) it is common practice to administer an antibiotic~     (cefazolin) at the end of surgery, to reduce the risk of post-operative endophthalmitis. The~     antibiotic is administered by injection underneath the part of the eye called the~     conjunctiva. However, this antibiotic injection is often associated with high levels of~     post-operative pain. Previous studies have observed a reduction of this pain by injecting an~     anesthetic (lidocaine) in the subconjunctival space before the antibiotic. This study will~     seek to examine whether mixing 2% lidocaine with cefazolin before its injection will reduce~     post-operative pain in the retinal surgery setting.~   "
55997|NCT02324153|"~     This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness~     and safety of peri-operative administration of ramelteon, a melatonin agonist in the~     prevention of postoperative delirium.~   "
55998|NCT02324140|"~     The study investigates inflammatory and antiinflammatory response in patients with severe~     aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement)~     or interventional cardiology treatment (transcatheter aortic valve implantation using the~     transfemoral access route or the transapical access route).~   "
55999|NCT02324127|"~     Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign~     liver diseases.~   "
56000|NCT02324114|"~     Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign~     colorectal diseases patients.~   "
56001|NCT02324101|"~     Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign~     breast diseases patients~   "
56002|NCT02324088|"~     To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after~     pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory~     breast cancer (IBC).~   "
56003|NCT02324075|"~     Background (brief):~        1. Burden: In low income neighborhoods in Dhaka many households share toilets which are~          often unsanitary and their discharge contaminates the community.~        2. Knowledge gap: Behavior change messages have the potential to make people concerned~          about maintaining shared toilets quality, cleanliness and safety of the facility. There~          are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's~          not clear that the situation can be improved with behavior change or even which~          specific messages to target.~        3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization~          working to improve shared sanitation facilities in Dhaka. They are interested in~          developing and evaluating a behavior change program to improve shared sanitation in~          Dhaka and to generate lessons that would be relevant for other low income urban~          settings globally.~      Hypothesis: A behavior change communication intervention can improve the quality and~     cleanliness of sanitation services available to low-income residents of Dhaka.~      Objectives:~        1. To deliver behavior change messages (which target key behaviors influencing the quality~          and cleanliness of shared sanitation facilities) to randomly selected low-income~          communities in Dhaka.~        2. To evaluate the effectiveness of a behavior change communication intervention designed~          to change targeted behaviors related to the quality and cleanliness of shared~          sanitation facilities.~      Methods:~      Local non-governmental organizations will deliver the intervention (behavior change~     communication package) in randomly selected communities. For this study the investigators~     will assess the impact of this intervention on the targeted behaviors using follow-up~     surveys and spot checks.~   "
56004|NCT02324062|"~     This study is about understanding the use of a genetic test (Myriad Genetics myRisk panel)~     that analyzes 25 genes related to different hereditary cancer conditions. The investigators~     hope to learn more about how this type of genetic test is used clinically. The investigators~     also hope to understand more about the experience of individuals and families who undergoing~     this test of genetic testing.~   "
56005|NCT02324049|"~     To evaluate the safety and tolerability of intravenous (IV) administration of SBC 103 in~     subjects with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable~     signs or symptoms of developmental delay.~   "
56006|NCT02324036|"~     The proposed study is a pilot study to gather data on the effectiveness and feasibility of a~     software tool (EMPATHy) to help patients communicate effectively with doctors about problems~     they face with their medication regimens. EMPATHy will be incorporated into an existing~     clinic-based intervention called Coached Care, in which community health workers (CHWs,~     non-professional community members) work as a Coach to patients to help them improve~     engagement and communication during the medical visit.~   "
56007|NCT02324023|"~     Cancer in the colon and rectum represents a global health burden being the most common~     cancer of the digestive tract. It is the second most common cancer in Denmark and only about~     half of the patients survive this diagnosis. Thorough characterization of the tumour~     preoperatively is very important, since it determines if the patient should be treated with~     chemotherapy before operation and, in the future, which operation would be most suitable for~     the patient.~      Research has shown that endoscopic ultrasound (EUS) is superior to a CT-scan, in determining~     the local growth of the tumour in rectal cancer. Today, a CT-scan is the image modality of~     choice, and is used in all Danish hospitals when it comes to colon cancer. Hopefully, the~     investigators can apply EUS in colon cancer patients and thereby alter our diagnostic~     approach, towards a quicker and safer way to determine which treatment the investigators~     should offer the patient.~      With the screening programme for colorectal cancer in Denmark the investigators will find~     more and more cases of colorectal cancers, especially in the early stages, before symptoms~     begin. These small tumours put doctors in several dilemmas concerning the strategy of~     treatment. Even today, the investigators are very reluctant in offering large-scale~     operations to elderly and fragile patients who have been diagnosed with cancer in the~     rectum. Instead, local endoscopic operations are performed in selected patients. This~     approach has not yet been tried in early colonic cancers. However, it might turn out that~     local, endoscopic surgery will show to be beneficial for patients with colon cancers and~     maybe even decrease morbidity, mortality and the regenerative period after surgery.~      The aim of this PhD-project is to investigate the utility of the EUS-method in~     characterizing tumours in the colon and in investigating the blood flow in the tumour.~   "
56008|NCT02324010|"~     The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial~     glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying,~     after a mashed potato meal in patients with type 2 diabetes.~   "
56009|NCT02323997|"~     This study will investigate the types of HPV in samples from women with cervical pre-cancer~     and cancer and gather information to help investigate the impact of HPV vaccination in~     Switzerland.~   "
56010|NCT02323984|"~     Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC~     Doppler) in both delirious groups and nondelirious group will be our primary target.~     Delirium assessment through standardized questionnaires will be done at baseline (day of the~     surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then~     every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed~     models to describe the change patterns overtime, and compare differences at each time point.~     Inflammatory biomarkers will be explored overtime as well. The investigators will also~     explore age effect on cognitive function - cognitive reserve - based on the score of the~     cognitive test administered at baseline.~   "
56012|NCT02323958|"~     This study is to observe whether transcutaneous electrical stimulation at specific acupoints~     could improve the quality of emergence in patients undergoing robotic laparoscopic~     gynecologic surgery.~   "
56013|NCT02323945|"~     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods~     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote~     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of~     the study is to understand the mechanisms by which intermittent hypoxia enhances motor~     function and spinal plasticity (ability of the nervous system to strengthen neural pathways~     based on new experiences) following SCI.~   "
56014|NCT02323932|"~     The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral~     cochlear implant hearing in comparison to unilateral cochlear implant hearing in the~     perception of speech intonation.~   "
56015|NCT02323919|"~     Using a randomized clinical trial with 3 groups, the investigators will conduct a~     head-to-head evaluation of two different theoretically-based interventions, SystemCHANGE and~     CHANGE+, as compared to Usual Care to improve the adoption and maintenance of exercise in~     older cardiac patients. SystemCHANGE, a novel intervention that focuses on environmental~     change uses System Improvement strategies to increase exercise, will be compared to CHANGE+~     (an intervention based contemporary cognitive behavioral strategies). Study questions are:~     (1) Is there a difference between SystemCHANGE, CHANGE+ and Usual Care in exercise adoption~     when controlling for covariates (age, race, functional capacity, body fat, co-morbidity,~     muscle or joint pain, exercise experience, home and neighborhood environment, and~     depression), for individuals following a cardiac rehabilitation program (CRP)? (2) Is there~     a difference between SystemCHANGE, CHANGE+, and Usual Care in exercise maintenance when~     controlling for covariates? (3) Do system changes, social support for exercise,~     problem-solving skills, motivation, health beliefs, and exercise self-efficacy mediate the~     effects of SystemCHANGE, CHANGE+, or Usual Care on exercise adoption? (4) Do system changes,~     social support for exercise, problem-solving skills, motivation, health beliefs, and~     exercise self-efficacy mediate the effects of SystemCHANGE, CHANGE+ and CHANGE+~     interventions in terms of health care spending, labor force participation and earnings, and~     household productivity?~      Older persons (N=420) recovering from cardiac events will be randomly assigned to the three~     groups. Measures of exercise adoption and maintenance (# of metabolic equivalents {METS}~     expended, and whether or not a subject remains exercising) will be taken for 1 year after~     completion of a CRP using heart rate wristwatch monitors, exercise diaries, and 7-Day Recall~     Survey. The effect of covariates also will be assessed. Mechanisms by which the~     interventions achieve their effects will be determined. Multivariate analyses will examine~     and compare the effects of the interventions over time. A cost-effectiveness analysis also~     will be conducted.~   "
56016|NCT02323906|"~     CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in~     combination with sorafenib for subjects with unresectable HCC who have received no prior~     systemic therapy for HCC. The dose escalation phase of the study will explore several dose~     levels of CC-122 in combination with sorafenib, followed by an expansion part of the study~     using the optimal combination dose regimen.~   "
56017|NCT02323893|"~     The goal of this study is to visualize biodistribution of a PET tracer called [18F]F-AraG~     through time in healthy human volunteers.~   "
56018|NCT02323880|"~     This phase I trial studies the side effects and best dose of selinexor in treating younger~     patients with solid tumors or high-grade gliomas that have come back (recurred) or do not~     respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
56019|NCT02323867|"~     This is a single arm pilot study for patients using α/β T cell-depleted PSCT in with~     alternative donor sources with hematologic malignancies receiving alternative donor~     (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the~     CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as~     determined by engraftment and GVHD, and one year leukemia free survival.~   "
56020|NCT02323854|"~     Post market prospective, non-randomized, single-arm, multicenter study, designed to~     demonstrate dose response of an ablation system using a percutaneous approach in patients~     with primary, metastatic, or recurrent primary lung tumors.~   "
56021|NCT02323841|"~     Currently conservative treatment for patients of childbearing affected by cervical cancer is~     reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The~     trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these~     patients wishing to preserve their reproductive function.~      In this context , recently literature show the results about the use of neo-adjuvant~     chemotherapy about the reduction of tumor volume and therefore the magnitude of the~     subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it~     becomes crucial a prospective analysis on the possibility to include in this type of~     treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm )~     .~      The current study , in fact , would like to do a prospective evaluation on the advantages of~     neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to~     conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with~     tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.~   "
56022|NCT02323828|"~     Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn~     starch on food intake and appetite control of a cohort of healthy students. Cookies were~     prepared with increasing RS content and were fed to 18 healthy students in a blind trial~     versus a placebo.~      Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet~     diaries, respectively).~   "
56023|NCT02323815|"~     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children~     younger than 5 years. 18.7 million children under five years of age suffer from severe acute~     malnutrition (SAM) and an additional 33 million children suffer from moderate acute~     malnutrition, and are at risk of developing SAM~      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute~     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -~     resulting in many missed opportunities for using prevention platforms to screen and refer~     SAM children, or for using screening and referral platforms to provide prevention services.~      This project will address two critical gaps related to the integration of preventive and~     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically~     integrated into routine health-center visits or mainstreamed into community outreach~     programs; and 2) screening programs do not offer any preventive services for those children~     found not to be suffering from MAM/SAM at the time of screening; mothers of children~     identified as non-MAM/SAM case are usually sent home without receiving any health or~     nutrition inputs and as a result, may fail to come back for screening because they do not~     see any tangible benefit associated with their participation in the screening. This project~     will specifically address these gaps by assessing the effect of an integrated approach~     consisting of higher screening coverage and preventive Behavior Change Communication (BCC) +~     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and~     treatment of child undernutrition.~   "
56024|NCT02323802|"~     Results after interventions on lifestyle in the secondary prevention of ischemic heart~     disease are not always consistent, and the Guidelines multidisciplinary measures aren't~     easily achievable.~      Therefore, the purpose of this research project is the identification of an interventional~     approach to effective secondary prevention and realistic feasibility, in a field of~     multifactorial risk. The study is open to patients who totaled a double chronic disease,~     obesity/overweight and coronary heart disease, and who experienced a first event of ischemic~     cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational~     intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first~     episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic~     approach of prescriptive diet therapy.~   "
56025|NCT02323789|"~     To assess whether intravenously administered third-party bone marrow-derived mesenchymal~     stromal cells (MSCs) are safe and have an impact on disease severity in RDEB~   "
56026|NCT02323776|"~     The purpose of this study is to identify features of the cumulative dose-volume histogram~     (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate~     these with postoperative complications.~   "
56027|NCT02323763|"~     The investigators propose to explore the link between bipolar disorder, anxiety, and suicide~     by investigating intertemporal discounting in depressed, suicidal patients with bipolar I~     and II disorder who have various levels of anxiety. The investigators will determine the~     effect of anxiety on their intertemporal discounting (small rewards now compared to larger~     rewards later) in a decision-making paradigm and investigate the associated functional~     neuroanatomy using functional magnetic resonance imaging (fMRI).~   "
56028|NCT02323750|"~     TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular~     dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify~     parameters/ biomarkers promoting and predicting the individual risk of transition. Results~     from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The~     implementation of common patient data sets and biobanking standards will enable data and~     biomaterial sharing with other DZHK study groups. This study will set the standard for a~     unique DZHK heart failure database and Biobank for innovative preclinical and clinical~     trials.~   "
56029|NCT02323737|"~     Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned~     to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of~     efficacy and toxicity of IP regimen was analyzed.~   "
56030|NCT02323724|"~     To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E~     BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V~     of Bethesda System)~   "
56031|NCT02323711|"~     This study is investigating the relative risks and benefits of using two common materials~     for coverage of the skin incision at cesarean delivery. We will perform the first~     prospective and the first randomized controlled trial examining the use of a standard~     postoperative dressing versus skin glue for coverage of the closed skin incision after~     cesarean delivery. The hypothesis is that using skin glue for coverage of the incision will~     be associated with decreased wound complications and increased patient satisfaction.~   "
56032|NCT02323698|"~     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods~     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote~     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of~     the study is to understand how caffeine may augment the effects of intermittent hypoxia on~     motor function and spinal plasticity (ability of the nervous system to strengthen neural~     pathways based on new experiences) following SCI.~   "
56033|NCT02323685|"~     Safety and effect of SANGUINATE on patients DCI following SAH.~   "
56034|NCT02323672|"~     45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15~     patients with oral malignant lesions and 15 control individuals. Levels of chemerin and~     MMP-9 were evaluated in serum and saliva of these subjects utilizing the ELISA technique.~   "
56035|NCT02323659|"~     Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life~     in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy~     treatment.~   "
56036|NCT02323646|"~     The primary objective of this study is to determine the safety and efficacy of two vaginal~     doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each~     separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine~     fibroids.~   "
56037|NCT02323633|"~     Children with ADHD display a certain brainwave profile which might be different to that of a~     child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation)~     has shown that this brainwave profile could possibly be altered to more closely resemble a~     brainwave profile of a child who does not have ADHD. Researchers believe that by changing~     this brainwave profile it might lessen symptoms of ADHD.~      tPCS is a name used to describe the type of current this device produces. It involves~     randomly (in no specific pattern) produced pulses of current at different times that the~     brain picks up. These pulses of low current stimulate the brain in a certain way and affect~     the brainwave activity.~      Treatment is given by applying a low frequency current using small electrodes clipped to the~     earlobes. The current comes from an external battery source. The pulses of current generated~     by this device stimulate certain parts of the brain which result in a possible increased~     control of attention and behaviour. This treatment has already been proven to be safe and~     will not hurt your child.~      Due to these specific parts of the brain being stimulated, and the positive results of~     previous research, it seems possible to control certain functions in children suffering from~     inattention and hyperactivity.~      The idea of using tPCS stimulation as a possible way for helping children with confirmed~     ADHD opens a new window to future research. The final goal of this device and research is to~     offer a safe, non-invasive (conservative treatment that does not require piercing into the~     body or the removal of tissue) treatment that can be used on a long-term basis and shows a~     clear improvement of ADHD symptoms for children and even adults with ADHD.~   "
56048|NCT02323490|"~     This study will compare meniscal healing augmented or without augmentation with bone marrow~     stimulation techniques The assessments will include validated, disease specific, patient~     oriented outcome measures, second look arthroscopy during second step ACL reconstruction.~     Results of this study will help ascertain whether microfractures improve meniscal healing~     rates.~   "
56038|NCT02323620|"~     This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its~     aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived~     mononuclear cells in addition to state of the art treatment is safe and reduces all-cause~     mortality in patients with reduced left ventricular ejection fraction (≤45%) after~     successful reperfusion for acute myocardial infarction when compared to a control group of~     patients undergoing best medical care.~   "
56039|NCT02323607|"~     This phase I trial studies the side effects and best dose of pacritinib when given together~     with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal~     change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving pacritinib and chemotherapy~     may be a better treatment for acute myeloid leukemia with FLT3 mutations.~   "
56040|NCT02323594|"~     Grps 1, 2, 3 This study will be testing the performance of ASV and DCV pediatric chewable~     tablets.~      Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg~     tablet~   "
56041|NCT02323581|"~     Prospective, nonrandomized, single-center, single-arm feasibility and safety study to assess~     the feasibility and safety of endovascular stent-graft implantation using a standard~     configuration branched and fenestrated stent graft (TAAA device) or physician-specified~     branched and fenestrated stent grafts (Physician-Specified TAAA Devices) for treatment of~     thoracoabdominal aortic aneurysms (TAAA) involving the mesenteric and renal arteries in~     patients at high risk for open surgery.~   "
56042|NCT02323568|"~     This project is part of a large multicenter multidisciplinary program that will thoroughly~     explore the needs and difficulties of patients with BCR as well as those involved in their~     care. The results of this research program will propose recommendations for better structure~     and understand the follow up of these patients.~      From the limited data in the literature, the long-term remission in patients with ovarian~     cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as~     well as somatic and mental illness; consumption is also a medical records for these~     patients.~      In this context, our team has initiated a large case-control study to assess fatigue~     (identified major problem in the long-term remission in patients with ovarian cancer), QoL~     and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of~     the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment,~     compared with women of the same age without ovarian cancer or serious chronic disease , from~     the general population.~      Patients and controls complement standardized and validated self-administered questionnaire~     (part 1). This study investigated 215 patients in long remission from ovarian cancer~     compared to 215 women of the same age without cancer. Recruitment of patients is currently~     underway, in close collaboration with teams from the Group GINECO very involved in this~     project.~      Following this step, an additional component is planned: it is to offer patients who~     participated in part 1, a specific gynecological consultation to assess in detail the~     effects of the treatments in order to better meet the needs of patients .dropoff window~   "
56043|NCT02323555|"~     A prescription of injectable anticancer therapy requires the collection of medical data~     (interview and physical examination) and often allied (laboratory tests). This requirement~     is made on the day of the arrival of the patient to not prepare these treatments~     incorrectly.~      After receiving the prescription of treatment, it will take about 1 hour to prepare for~     pharmacy and more in times of high activity, to provide the day hospital pockets treatment,~     incompressible time when the patient waits to have his treatment.~      A process has been selected (Optima) to anticipate prescribing injectable cancer treatments~     and their manufacturing to reduce patient waiting times on the day of his coming François~     BaclesseCentre day hospital.~   "
56044|NCT02323542|"~     The present study aims at investigating the effect of ingesting 2 cereal products differing~     by their SDS content on the kinetics of glucose in healthy volunteers.~   "
56045|NCT02323529|"~     The purpose of this study is to look at the steady-state serum concentrations of nitisinone~     when switching from twice daily and once daily dosing.~   "
56046|NCT02323516|"~     The mechanisms of action of the side effects associated with targeted therapies are still~     poorly understood. He was found in patients treated with gefitinib, increased levels of~     thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane~     A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane~     synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic~     properties as follows: stimulation of platelets and activation of other increased platelet~     aggregation.~      The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin~     is expressed by platelets and endothelial cells.~      The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest~     a role of platelet activation in the occurrence of side effects associated with targeted~     therapies.~      Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of~     low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the~     occurrence rash and diarrhea induced by gefitinib.~      In this study, the group of patients treated with acetylsalicylic acid presented a lower~     rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5%~     (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid.~     Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in~     the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally,~     in this study, it was not revealed significant differences in terms of response to treatment~     with gefitinib (37% in the standard group versus 33% in the group treated with aspirin~     patient) It does not exist in our knowledge of prospective data evaluating the effect of~     acetylsalicylic acid on the reduction of side effects associated with targeted in a~     population of patients of Caucasian-type treatment.~   "
56047|NCT02323503|"~     Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF),~     hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35%~     and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic~     function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is~     associated with a significant reduction in the risk of subsequent life-threatening~     ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for~     defibrillator back-up after an event-free first CRT-D service-life for patients with~     improved LVEF is a controversy question.~      80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary~     prevention do not experience VTA during the life-time of their first device.~      So, regarding patients implanted with a CRT-D for primary prevention at the time of first~     implantation, the question is will they experience VTA after their device replacement by~     another CRT-D.~   "
57350|NCT02306447|"~     Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck~     muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related~     cortical activity and neck muscles tension.~   "
56049|NCT02323477|"~     The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of~     allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in~     myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery~     prior to the cell administration. This 2-year study comprise three independent groups, where~     the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20),~     and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells~     will be administered to the approximately 10 peri-infarct areas at one time. The infarct~     zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80~     years of age. The efficiency of the therapy will be evaluated according to the parameters~     measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements~     prior and 6, 12, 18 and 24 months after the operation.~   "
56050|NCT02323464|"~     300 patients with colorectal cancer will be investigated before surgery and 60 of them will~     also be investigated in the same manner after surgery. Investigations will include~     polysomonographic sleep apnea recordings during one night, lung function measurements, blood~     gas samples and a questionnaire, but only before surgery including questions on sleep, sleep~     apnea, lung disorders.~      Outcome: side effects of surgery and mortality rate, association with cancer type.~      Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after~     surgery.~   "
56051|NCT02323451|"~     This study evaluates the safety and efficacy of investigational products in the treatment of~     knee Osteoarthritis. Half of participants will receive medical chitosan, while the other~     half will receive sodium hyaluronate.~   "
56052|NCT02323438|"~     A single-center, randomized, controlled, switching, open-label, parallel cohort study.~     Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline~     assessments during ad libitum smoking will occur for the first 3 days. Following baseline,~     subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and~     post-product switch assessments will occur for 6 days.~   "
56053|NCT02323425|"~     The purpose of this study is to evaluate the protective effects of upper limb ischemic~     postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis~     and the baseline characteristics of trial participants, as an open, randomized controlled,~     prospective controlled trial.~   "
56054|NCT02323412|"~     Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age~     groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83~     million YLDs in 2010. The burden is accordingly substantially higher than previously~     assessed, causing activity limitation and work absence with subsequently enormous economic~     burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial~     part is hospital costs. The research project responds to this challenge and aim to conduct a~     multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and~     molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that~     antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc~     herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low~     virulent anaerobic organisms in the disc. Investigators also want to add important new~     knowledge to the research field beyond the only former RCT by broadening the inclusion~     criteria to include both patients with type I and type II MCs, improving the MRI assessment~     of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and~     protein expression of inflammatory biomarkers, and conducting health economic analysis.~   "
56055|NCT02323399|"~     The primary objective of this study is to evaluate the dose effect of Phenylephrine~     Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in~     the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial~     anesthesia.~      The secondary objectives are to describe changes in blood pressure and heart rate, time to~     onset and to maximal response, and the duration of response; to assess the safety of the~     product in this population; and to characterize the pharmacokinetics of phenylephrine~     hydrochloride.~   "
56056|NCT02323386|"~     Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per~     year. Statistics indicate that for patients over 60 year old approximately one out of 20~     will require corrective reoperations within 10 years after surgery. However, for patients~     younger than 60 years, approximately one out of 10 will require revision total knee~     arthroplasty within 10 years of surgery. As the number of younger patients is increasing,~     there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative~     function and implant longevity being the important issues for quality of patient care.~     Furthermore, it has been reported that up to 25% of patients are not satisfied with the~     functional results of their TKA. In vivo the gold standard for obtaining reliable 3D~     measurements is RSA. However these are often static, because of even most advanced x-ray~     film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic~     RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB)~     conditions with active muscle contraction.~      The purpose of this study is to investigate the effect of a new implant design on the~     post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A~     prospective randomized study will be performed on a new implant: the DePuy ATTUNETM~     fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.~   "
56057|NCT02323373|"~     This clinical trial investigated two different routes of administration of tranexamic acid~     in total knee arthroplasty: topical compared to intravenous.~   "
56058|NCT02323360|"~     The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group~     superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable~     HCC treated with a TAE/TACE incomplete cycle.~   "
56059|NCT02323347|"~     At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program~     should fresh embryo transfer (ET) be cancelled?~   "
56060|NCT02323334|"~     This study involves single and multiple doses of LY3202626 and will evaluate the effects of~     LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single~     increasing doses of LY3202626 will be given in capsule form. Part A will also include~     itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B~     will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple~     days with the study drug. Part C will last approximately 11-14 weeks. Part D will last~     approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may~     only enroll in one part.~   "
56063|NCT02323295|"~     This study is designed to characterize the effects of high energy radiation on bone~     breakdown, with a specific interest in reducing the rate of sacral fractures. Although~     radiation is very important in managing tumors, it is related to complications such as bone~     fractures. In this research study, the investigators are looking to determine changes in~     blood markers, bone density, and bone structure following radiation and to better understand~     the reason for these changes.~   "
56064|NCT02323282|"~     To determine the median effective concentration of ropivacaine hydrochloride for~     ultrasound-guided supraclavicular brachial plexus block. The result can provide reference~     for choosing appropriate drug concentration in clinical anesthesia.~   "
56065|NCT02323269|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a~     12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are~     treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or~     switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response~     defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined~     by the Prescribing Physician. The secondary objectives of this study in this study~     population are: To assess the impact of DMF over a 12 month period on patient reported~     outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical~     outcomes at Month 12.~   "
56066|NCT02323256|"~     This study aims at investigating new automatic fitting techniques for cochlear implant~     patients based on objective measures. For this reason, the evolution of these~     neurophysiological measures, expressing the encoding of pure tones and speech, will be~     characterized in cochlear implanted patients as a function of post-implantation time and~     will be compared to those of normal hearing subjects. Moreover, the effect of auditory~     training with new tools based on serious games will be assessed.~   "
56067|NCT02323243|"~     Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing~     of the striated sphincter activity during voiding and characterizes the spinal cord injuries~     located under the protuberance. The standard treatment for DSSD is medical, either~     pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are~     unable to perform CISC and require alternative surgical techniques such as external~     sphincterotomy which is invasive, irreversible and with no adjustment period for the~     patient.~      Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary~     stents provide a non-definitive treatment, especially for evolutionary pathologies, for~     patients refusing a destructive surgery (psychosocial impact), or for patients having not~     defined yet their therapeutic preference. The Allium company has developed the  Bulbar~     Urethral Stent  (BUS) system, which advantages are the possibility to perform the procedure~     under local anesthesia and to remove more easily the stent, with similar performances~     compared to the other devices. In order to quantify the interest of the BUS system, the~     investigators propose to perform a prospective study aimed at describing its technical and~     clinical results in terms of efficacy and safety.~   "
56068|NCT02323230|"~     This phase 2 study is designed to assess the efficacy and safety of DPX-Survivac plus low~     dose cyclophosphamide in subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who~     are not eligible for transplant.~   "
56069|NCT02323217|"~     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the~     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric~     conditions such as depression and addiction, along with neurodegenerative disorders such as~     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated~     functional interactions with the opioid system, where I2BS ligands have been shown to affect~     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.~     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic~     effects in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing~     Phase II clinical trials as a novel treatment for neuropathic pain and acute non- specific~     pain states.~      The location of I2BS on astrocytic glial cells and the possibility that they may in some way~     regulate glial fibrillary acidic protein have led to increased interest into the role of~     I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has~     been shown to increase in Alzheimer's disease post mortem, and it has also been suggested~     that I2BS may be a marker for the severity and malignancy of human glioblastomas.~      The lack of suitable imaging tools for the I2BS has meant that information regarding the~     number and distribution of I2BS in the brain has come from preclinical species and in vitro~     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to~     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional~     distribution in the living human brain. In this study the investigators plan to utilise~     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo~     using PET.~   "
56070|NCT02323204|"~     Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's~     Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's~     Hospital with an injury resulting in admission will be the sample population. A child will~     be included if they are 10-17 years old with an unintentional injury. Consenting children~     and their parents will be asked to complete a series of four questionnaires: before hospital~     discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child~     dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma~     Education. The survey completed in the hospital will be a paper survey or online via an~     iPad, and follow-up surveys can be completed on paper or online.~      Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with~     parents and providers of previously injured children from UI Children's Hospital.~      Aim #2: Through a randomized trial, determine the range of potential psychosocial and~     behavioral health indicators possibly impacted by Link for Injured Kids. This will identify~     the types of outcomes which could include post-traumatic stress disorder (PTSD), depression,~     nonspecific distress, quality of life, absenteeism, school performance, coping skills,~     communication skills, and access to mental health.~   "
56086|NCT02322996|"~     The goal of the current study is to combine existing and new tools for quantifying patient~     self-report to characterize changes in acute pain. The ability to quantitatively measure~     self-report provides behavioral pain phenotypes that can serve as the basis for clustering~     patients into sub-groups based on their self-report of their symptoms, eliminating observer~     based perceptions of patients' pain.~   "
56071|NCT02323191|"~     This Phase 1, open-label, multicenter, global study will evaluate the safety,~     pharmacokinetics, and activity of RO5509554 and MPDL3280A administered in combination in~     patients with selected locally advanced or metastatic solid tumors that are not amenable to~     standard treatment.~      Patients who receive MPDL3280A and RO5509554 will continue to receive study drug as long as~     they experience clinical benefit in the opinion of the investigator or until unacceptable~     toxicity or symptomatic deterioration attributed to disease progression as determined by the~     investigator after an integrated assessment of radiographic data, biopsy results (if~     available), and clinical status, or withdrawal of consent.~   "
56072|NCT02323178|"~     Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.~   "
56073|NCT02323165|"~     The primary aim is to determine if this new technique will detect and identify bacteria in~     the blood sooner than standard blood cultures or identify patients who may be septic without~     growing bacteria in their cultures. These will be correlated with the data collected from~     medical records on presumed sepsis. These results will be linked to data concerning~     infection that will be available as part of routine care including blood counts and other~     laboratory values that would be part of the routine medical care such as a white blood cell~     count. The earlier the bacteria are identified and the appropriate antimicrobials are~     administered the better the patient outcome.~   "
56074|NCT02323152|"~     Postpartum depression is a disease with a prevalence of 10% which has not only deleterious~     consequences for the mother but also for the baby and can delay the physical, social and~     cognitive development of the baby. Therefore we consider very important to prevent this~     disease as from the centers of care for women with a multidisciplinary approach. The aim of~     this study is to determine whether psychoeducation oriented in problem solving is effective~     in preventing the development of postpartum depression in women with very high risk.~      Methodology: screening of 1000 women in 3rd trimester of pregnancy. We expect that 25% have~     at least one risk factor for postpartum depression (250). Of these women, aproximately a 50%~     will have a very high risk of developing postpartum depressión and will be included in the~     study (n = 125). These women will be randomized to two groups: treatment with psychotherapy~     focused on problem solving (6 sessions: 1 individual session + 5 group sessions) or usual~     care control group (usual postpartum control).~      After treatment, women will be evaluated twice, at the end of therapy and at 6 weeks.~     Survival curves will be used tu assess the time it takes patients to develop major~     depression in the postpartum.~   "
56075|NCT02323139|"~     This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in~     patients without marrow response after at least 6 cycles of azacitidine.~   "
56076|NCT02323126|"~     To determine the efficacy and safety of Nivolumab in combination with EGF816 and of~     Nivolumab in combination with INC280 in previously treated NSCLC patients~   "
56077|NCT02323113|"~     The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and~     maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in patients with~     relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate~     preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall~     response rate (ORR).~   "
56078|NCT02323100|"~     We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement~     therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial~     cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport~     during the nasal potential difference (NPD) test.~   "
56079|NCT02323087|"~     The purpose of this study is to determine whether point-of-care susceptibility testing~     improve correct choice of antibiotics, clinical and microbiological outcome in patients with~     uncomplicated urinary tract infection in general practice compared to point-of-care urine~     culture.~   "
56080|NCT02323074|"~     In this project we will design a control algorithm to identify the focalized motor-related~     clusters for hand function on each stroke patient. A real-time feedback will control the~     robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot~     training will be compared in a randomized controlled trial to evaluate the training~     effectiveness and changes in the EEG patterns.~   "
56081|NCT02323061|"~     A BCI system for stroke subjects will be designed in an attempt to train the motor-related~     areas in their brains responsible for hand open/close function. A robot hand will be used~     and controlled by the system in real time based on EEG pattern for identification of motion~     intention for hand movements in the motor cortex. A randomized controlled trial study design~     will be adopted. All subjects will be assessed by clinical assessments including FMA and~     neuroimaging assessments using multimodal MR techniques before and after the training to~     evaluate training effectiveness.~   "
56082|NCT02323048|"~     The aim of the study is to extend our investigations of drug-associated conditioning with~     healthy volunteers. The investigators have recently completed a pilot study demonstrating~     that subjects show an increase in self-reported preference for a visual stimulus paired with~     stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts~     synergistically with rewards in the environment, such that this conditioning effect is~     facilitated by experiencing the drug in the presence of rewarding, or positive events, such~     as earning money. The investigators now aim to extend these findings by assessing not only~     self-reported preference, but also attentional and psychophysiological (electromyogram; EMG)~     responses to the drug-associated stimuli.~   "
56083|NCT02323035|"~     This investigation is designed to evaluate the at-home usability, performance, user~     acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.~   "
56084|NCT02323022|"~     The purpose of this study is to compare the clinical efficacy and safety of IAC regimen and~     IA regimen as induction chemotherapy for initial diagnosed AML patients. 840 cases are~     supposed to recruited in 3 years.~   "
56085|NCT02323009|"~     This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to~     overcome negative transpulmonary pressure; or adjusted by use of CStat to achieve the best~     effective static compliance will have any effect on outcomes with respect to ventilator~     weaning in tracheotomized morbidly obese patients (BMI >=40) with at least one failed prior~     weaning attempt.~   "
57980|NCT02298231|"~     This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR)~     training system in providing a customized balance treatment in a skilled clinical setting.~     Participants will be assigned to one of three treatment groups.~   "
56087|NCT02322983|"~     Cerebral Palsy induces oral alterations that impact on oral health, requiring dental~     treatment. The objective of this study was to evaluate the use of conscious sedation with~     nitrous oxide (N2O) in the control of stress during dental treatment in individuals with~     Cerebral Palsy.~   "
56088|NCT02322970|"~     Investigators aim to assess sensitivity and specificity of transcranial doppler in~     determining intracranial hypertension in all patients admitted to intensive care unit for~     brain injury and needing Intracranial Pressure (ICP) monitoring (according to international~     guidelines). Non invasive ICP measurement through the use of transcranial doppler will be~     carried out before and after standard invasive ICP monitoring placement; a head computed~     tomography (CT) scan will also be performed before and after interventions.~   "
56089|NCT02322957|"~     This study is designed to evaluate the potential for a PK drug-drug interaction between~     FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover~     design in healthy volunteers.~   "
56090|NCT02322944|"~     This study aims to develop quality improvement strategies and relevant tools focusing on~     reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a~     hospital-level cluster randomized clinical trial, based on the nationally representative~     collaborative network of over 100 hospitals established in China PEACE retrospective study.~     In a baseline survey period, through consecutively recruiting all eligible inpatients and~     collecting relevant medical information, the performance of all participating hospitals~     before the implementation of the intervention will be assessed. During the following~     intervention period, 6-10 hospitals that show the strong willingness and ability to~     collaborate will be selected as process optimization group. Their clinical pathways and~     team building will be re-organized for the purpose of quality improvement, and develop~     individualized treatment strategies and process. Meanwhile, other participating hospitals~     will be divided into intervention and control groups in a 1:1 ratio, in which the~     intervention group will take the treatment improvement strategy into implementation, while~     the control group will maintain the routine practice pattern. All hospitals will~     consecutively recruit qualified patients in the same method adopted in baseline period. Then~     the reperfusion rates and other performance measures will be compared among different groups~     (process optimization, intervention and control).~   "
56091|NCT02322931|"~     The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT~     imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR)~     brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for~     prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT~     imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric~     measures will be compared to those using the standard Day-0 CT images. The investigators~     hope that the intraoperative 3D C-arm provides quality assurance measures sufficient to~     eliminate the need for Day-0 CT LDR brachytherapy and provide the opportunity for~     intraoperative modification of seed delivery plan.~   "
56092|NCT02322918|"~     The purpose of this study is to determine if candidate polymorphisms in brain-derived~     neurotrophic factor (BDNF) and catechol-o-methyl transferase (COMT) are predictive of~     psychosis disorder severity, symptomology, and resolution in patients at BCPP. A secondary~     objective will be to form a biorepository of blood and saliva samples from patients at BCPP~     so that further genetic, proteonomic and pharmacogenomic studies may be done to gain insight~     into the genetic basis of differences in psychosis disorder presentation and manifestation,~     and differences in response to antipsychotic drug treatment.~   "
56093|NCT02322905|"~     Informal caregivers of cancer patients report high levels of psychological distress as~     evidenced in markedly increased levels of anxiety and depression. High levels of~     psychological distress in caregivers have also been found to be associated with poorer~     health and increased levels of pro-inflammatory cytokines that are well-established risk~     factors for physical illness and stress-related mortality. Previous psychological~     interventions using cognitive methods have only produced small effect sizes and more~     research on how to effectively alleviate caregiver burden is needed. The proposed project~     will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer~     patients. ERT is a novel approach specifically targeting emotion regulation with the aim of~     improving mental and physical health. The effect of ERT will be examined in a randomized~     controlled trial comparing ERT to usual medical care (UMC).~   "
56094|NCT02322892|"~     The main purpose of this pilot study is to test the effects of thiamine (vitamin B1)~     administration before and after major cardiac surgery. Half of patients will receive~     thiamine and the other half will receive placebo.~      The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption~     and lead to decreased levels of post-operative lactate levels and ultimately improved~     patient outcomes.~   "
56095|NCT02322879|"~     A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating~     pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to~     determine if it prevents the formation of the toxic metabolites of acetaminophen.~   "
56096|NCT02322866|"~     To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline~     compared to placebo in the treatment of moderate to severe facial acne vulgaris~   "
56097|NCT02322853|"~     Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of~     the effect of systemic treatments. After relapse on first-line non-steroidal aromatase~     inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant~     (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but~     in this context of resistance, their efficacy are poor.~      Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic~     setting by a combination with therapy targeting signal transduction pathways. Other~     transduction pathways seem to be involved in endocrine sensitivity/resistance, such as~     RAS/RAF/MEK/MAK pathway.~      LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of~     p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated~     protein kinase 2 (MAPKAP-K2).~   "
56098|NCT02322827|"~     This study is designed to see how HIV infected patients perform when taking a single fixed~     dose HIV medication compared to a regimen with multiple tablets. The study is also going to~     be looking at the differences in complications between the two groups.~   "
56099|NCT02322814|"~     This multistage, randomized, Phase II, double-blind, multicenter, placebo-controlled trial~     will evaluate the safety and tolerability and estimate the efficacy of cobimetinib +~     paclitaxel versus placebo + paclitaxel in patients with metastatic or locally advanced,~     triple-negative adenocarcinoma of the breast that have not received prior systemic therapy~     for metastatic breast cancer (MBC). An open-label safety run-in stage of the combination~     cobimetinib + paclitaxel will undergo an Internal Safety Review before starting the~     enrollment of patients into the expansion double-blind stage of this study. Patients may~     continue on study treatment until the development of progressive disease, unacceptable~     toxicity, and/or consent withdrawal. The target sample size is 12 patients for the safety~     run-in stage and approximately 100 patients in the expansion stage.~   "
56100|NCT02322801|"~     This multi-center, observational, retrospective-prospective cohort study will investigate~     the safety of rituximab (MabThera) by collecting data from daily clinical practice on the~     use of rituximab and its relative clinical impact, particularly with regard to adverse~     events. Data from each patient will be collected over 24 months after enrolment in the~     study. Target sample size is up to 325 patients.~   "
56101|NCT02322788|"~     A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way~     cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared~     to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced~     bronchoconstriction in patients with stable, mild to moderate asthma~   "
56102|NCT02322775|"~     The purpose of this trial is to confirm the safety and clinical benefit of benralizumab~     administration in asthma patients with mild to moderate persistent asthma in order to gain~     an understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.~   "
56103|NCT02322762|"~     DISCOVER is a Non Interventional Study study to describe the disease management patterns and~     clinical evolution over three years in type 2 diabetes mellitus patients initiating a second~     line anti-diabetic treatment.~   "
56104|NCT02322749|"~     A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant~     of selumetinib capsule are comparable, and to assess how drug levels differed in another~     variant of Selumetinib in Healthy Male Volunteers.~   "
56105|NCT02322736|"~     The study will shed additional light on the impact of Vectibix® under the current, standard~     clinical conditions of mCRC treatment in Greece. It will provide data on the duration and~     the outcomes of Vectibix® treatment in real-life setting.~   "
56106|NCT02322723|"~     In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient~     real life setting. Moreover, the association between long-term effectiveness of Adalimumab~     and patients' functional status as well as cultural aspects of sick leaves and visits to~     physician's clinics has not been demonstrated in this population. This study will collect~     the required data in real life settings.~   "
56107|NCT02322710|"~     Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in~     the treatment of surgical acute wounds.~   "
56108|NCT02322697|"~     Patients on chronic hemodialysis without obstructive coronary artery disease identified by~     coronary angiography were randomly divided into the two groups: carnitine group and control~     group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous~     administration of L-carnitine (1000 mg on every dialysis session). Control group received~     the examination of BMIPP SPECT at the same time of the carnitine group. The effects of~     chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism were~     investigated among this population.~   "
56109|NCT02322684|"~     The purpose of this study is to assess the success rate of bougie-guided endotracheal~     intubation compared to blind intubation through the Air-Q intubating laryngeal mask~   "
56110|NCT02322671|"~     This study is designed to estimate the bioavailability of montelukast from the 5 milligrams~     (mg) montelukast sodium (GW483100) test formulations relative to 5 mg montelukast sodium~     reference chewable tablets (innovator product). It is an open-label, randomized, single~     dose, three-way cross over, six sequence study in 18 healthy human subjects. Each subject~     will participate in all three treatment periods. Subjects will be randomized to one of six~     sequences and administered one of the three treatments A, B or C in each treatment period,~     where Treatment A is 5mg chewable tablet of reference 5 mg montelukast sodium reference~     chewable tablets (innovator product), Treatment B is test formulation 1: 5mg montelukast~     sodium (GW483100) chewable tablet and Treatment C is test formulation 2: 5mg montelukast~     sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout~     period of 7 to 14 days. Total duration in the study for each subject will be approximately 8~     weeks from screening to the follow-up visit.~   "
56111|NCT02322658|"~     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single~     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed~     conditions.~   "
56112|NCT02322645|"~     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single~     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting~     conditions.~   "
56113|NCT02322632|"~     An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,~     crossover oral bioequivalence study in healthy subjects under fasting conditions.~   "
56114|NCT02322619|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover, oral bioequivalence study in human subjects under fasting conditions.~   "
56115|NCT02322606|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     TAK-137 in healthy male subjects.~   "
56116|NCT02322593|"~     The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared~     with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.~   "
56117|NCT02322580|"~     The purpose of this study is to investigate the association between trough serum levels of~     etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.~   "
56118|NCT02322567|"~     The purpose of this study is to examine the relationship between pre-operative LV diastolic~     function and post-operative complications and kidney function in living-donor kidney~     transplantation patients.~   "
66394|NCT02188290|"~     Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control~     data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).~   "
56119|NCT02322554|"~     The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide~     real world patient data from electronic health records submitted to meet Stage 2 Meaningful~     Use in order to understand the value of these products among patients with chronic wounds~     and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude~     patients with the co-morbid conditions common to patients seen in usual clinical practice~     and thus the results of these RCTs tend to be non-generalizable. Little is known about the~     effectiveness of CTPs among typical patients.~   "
56120|NCT02322541|"~     The study will consist of a single 5-day dietary treatment period. Subjects will consume an~     Allium-free diet for 3 days. Alliums are vegetables such as garlic, onions, chives,~     shallots, and leeks. On day 4, subjects will consume a breakfast consisting of garlic and~     will then provide blood and urine samples for 10 hours, and on the following morning.~   "
56121|NCT02322528|"~     The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®)~     on the surface of the eye and tear film (a film that coats the eye which is made up of oil~     and water).~   "
56122|NCT02322515|"~     The relevance of this study is to determine the effects of a patellar taping on muscle~     activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius~     (GM) during different proprioceptive exercises frequently utilized in rehabilitation~     program.~   "
56123|NCT02322502|"~     The aim of this study is first to assess if desflurane is superior in order to achieve a~     faster emergence from anesthesia.~   "
56124|NCT02322489|"~     15 participants will be included in the present study. They will attend two groups of three~     sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:~        -  session 1 and 4 (performed a few days before the experimental session): session for~          participants to get familiarized with the test battery.~        -  session 2 and 5: experimental session (the test battery followed by the provocative~          task, the test battery, the one-hour treatment and the test battery again).~        -  session 3 and 6 (performed 2 days later): the test battery.~      The test battery included flexibility, functional, pressure pain threshold tests.~      The provocative task was an isokinetic eccentric task for knee flexors and extensors.~      The treatment was either a microcurrent therapy or a placebo microcurrent therapy.~   "
56125|NCT02322476|"~     Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care~     unit (ICU). Several studies have documented a high frequency of HSV reactivation in~     critically ill patients despite that clinical impact remains unknown.~   "
56126|NCT02322463|"~     Early and appropriate pain management in the emergency department (ED) is an important~     aspect of child care. Studies in the adult population revealed that ethnicity might be~     associated with disparities in analgesia and opioid treatment in ED patients suffering from~     limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic~     practice in the pediatric ED. The objective of this study is to determine whether minority~     population Arab children with orthopedic injuries are less likely than Jewish children to~     receive oxycodone for limb fracture.~   "
56127|NCT02322450|"~     2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week~     administration of QGC001 oral doses in patients with grade I or II essential hypertension~     compared to placebo, to assess the safety and tolerability, to obtain preliminary PK~     information for QGC001 given as multiple oral doses and to determine preliminary PD profile~     of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that~     of placebo.~   "
56128|NCT02322437|"~     This study aims to evaluate whether psychiatric home treatment is an effective and efficient~     alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of~     psychiatric patients in need of hospitalization are randomly assigned to either treatment at~     inpatient wards (treatment as usual) or a new care model with the additional option of~     treating patients at their homes by mobile care teams. The primary focus is on checking~     whether optional home treatment leads to a reduction of inpatient days during a two-year~     follow-up period. In addition, the two service models will be compared regarding treatment~     cost and outcomes as well as satisfaction of patients and their relatives with psychiatric~     care.~      Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be~     examined by a highly trained clinical assessor to test and verify the diagnoses and the~     clinical ratings made by the staff members of the mental hospital under routine everyday~     conditions.~   "
56129|NCT02322424|"~     Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic~     Fistula (ISGPF) is associated with a life-threatening complication after~     pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors~     for grade C PF by Japan and Taiwan cooperative project.~   "
56130|NCT02322411|"~     The overall goal of this randomized controlled pilot study is to characterize effects of~     SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO)~     therapy in a dose response framework on swallowing-related outcomes in a group of unilateral~     ischemic stroke patients. These results will be used to determine adequate sample size in~     order to support a larger clinical trial focused on the efficacy of this therapy approach~     for improving swallowing safety. The first aim is to determine differences in swallowing~     physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects~     undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of~     treatment. The second aim is to examine changes in level of oral intake and swallowing~     quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control~     group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third~     aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the~     number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects~     undergoing DF I-PRO therapy compared to controls.~   "
56131|NCT02322398|"~     The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization~     (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The~     study compared the pregnancy rate obtained by 398 patients who had received COS with~     recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH)~     in 2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal~     Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.~   "
56132|NCT02322385|"~     Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA~     analysis using the next generation sequencer (NGS) and examine the relationship between~     mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by~     Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and~     non-ADPKD family members.~   "
56133|NCT02322372|"~     The investigators of the current study aimed to evaluate the effect of spinal anesthesia~     with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time~     of first analgesic requirement during postoperative period~   "
56134|NCT02322359|"~     Context: Chest compressions represent an important physical effort leading to fatigue and~     cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest~     compressions interruptions, current guidelines still recommend provider switch every 2~     minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary~     resuscitation remains to be assessed.~      Study design: simulated prospective monocentric randomized crossover trial. Participants and~     methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital~     of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of~     continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a~     feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by~     reached target of rate, depth and leaning at the same time (recorded continuously).~      Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary~     resuscitation.~   "
56135|NCT02322346|"~     The investigators aimed to evaluate the effects of different concentrations of preincisional~     peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding~   "
56136|NCT02322333|"~     This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects~     agreeing to participate in the study and meet the entry criteria assessed at the screening~     visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish~     baseline migraine characteristics. During this baseline period, subjects will continue~     treating their migraines as usual, simply recording the information in a daily headache~     diary. Subjects who, after completing the baseline, continue to meet entrance criteria will~     be eligible to enter into the treatment phase and be randomized according to the Clinvest~     generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be~     randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6~     United States sites. Diary assessments will collect study medication adherence, pain~     severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples~     will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.~   "
56137|NCT02322320|"~     This study is designed to compare long-term outcomes among patients randomized on the BMT~     CTN 0702 protocol (NCT01109004), A Trial of Single Autologous Transplant with or without~     Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for~     Patients with Multiple Myeloma. It is hypothesized that use of novel anti-myeloma agents~     will improve long-term progression-free survival (PFS) after high-dose melphalan followed by~     autologous hematopoietic cell transplantation (HCT) as compared to a second autologous~     transplantation.~   "
56138|NCT02322307|"~     HealthPROMISE is a mobile application (app) for patients that allows regular tracking of~     symptoms by patients and communicates them to physicians. The purpose of this randomized~     controlled trial is to determine the impact of the HealthPROMISE application on improving~     patient outcomes. The trial will look at how much patients use the application, whether~     physicians change treatment in response to new information from patients, and how the~     patients quality of life change over the span of the study. The investigators hypothesize~     that HealthPROMISE will enhance physician-patient communication and improve clinical~     outcomes.~   "
56139|NCT02322294|"~     This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on~     glucose parameters, triglycerides and body weight as compared to a placebo. Half of the~     subjects will be administered Glucodia™, while the other half will receive placebo.~   "
56140|NCT02322281|"~     The purpose of this study is to compare the anti-tumor efficacy of oral single-agent~     rociletinib, as measured by investigator assessment of the PFS, with that of single-agent~     cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after~     failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing~     doublet chemotherapy.~   "
56141|NCT02322268|"~     The purpose of this study is to determine whether Cosmos caudatus is effective as an~     adjuvant therapy for type 2 Diabetes Mellitus.~   "
56142|NCT02322255|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life~     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza~     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to~     cumulative loss of function and disability. This 3-year, non-interventional, two-part,~     natural history study is designed to gain insight into total body HO, FOP disease~     progression, the impact of FOP on subjects' physical functioning, and clinical features and~     biomarkers that may be useful in the diagnosis and monitoring of disease progression. This~     natural history study will also provide important information to inform the design of~     subsequent interventional trials.~   "
56143|NCT02322242|"~     A standard interscalene nerve block is performed with long acting local anesthetic~     (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of~     this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to~     a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block~     compared to ropivacaine alone for interscalene block with systemic dexamethasone.~      Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a~     nerve block.~   "
56144|NCT02322229|"~     The purpose of this study is to observe the anatomical and functional outcomes of~     ocriplasmin (JETREA®) over a 6-month follow-up period.~   "
56145|NCT02322216|"~     The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to~     olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with~     allergic conjunctivitis.~   "
56146|NCT02322203|"~     Background:~      - Niacin is a vitamin in many foods, including meats, fish, fruits, and vegetables. It is~     often used as a dietary supplement that causes many improvements in the body. Researchers~     think it can affect heart health.~      Objective:~      - To better understand the good effects of niacin supplementation on cholesterol, fat~     metabolism, and vascular health.~      Eligibility:~      - Adults 18 years of age and older with fasting good cholesterol (HDL-C) below 60 mg/dL.~      Design:~        -  Participants will come to the clinic 4 times during the study.~        -  They will complete a 7-day food journal before visits 1 and 3.~        -  At visit 1, participants will be screened with questions about their diet and exercise,~          medical history, and any drugs and vitamins they take. Vital signs and body mass index~          will be measured.~        -  They will have a Cardio-Ankle Vascular Index (CAVI) test of the arteries. Blood~          pressure will be taken in the arms and legs and the heart will be monitored.~        -  Blood will be drawn. Participants will fast for 8 12 hours before this.~        -  Women will have a pregnancy test.~        -  Eligible participants will get a 2-week supply of niacin. They will take 2 tablets~          daily for one week, then 4 daily.~        -  Visit 2 will be 2 weeks after visit 1 and the niacin dose will be increased. Visit 3~          will be 16 weeks after visit 1, and participants will stop taking niacin. Visit 4 will~          be 4 6 weeks after stopping niacin.~        -  During study visits, participants will repeat visit 1 tests.~   "
56147|NCT02322190|"~     Background:~      - Some allogeneic stem cell transplant recipients get acute graft-versus-host disease~     (GVHD). They always get steroids as the first treatment, but this may not work. Those people~     where steroids are not enough may benefit from a treatment called extracorporeal~     photopheresis (ECP). ECP exposes white blood cells to ultraviolet light outside the body.~     Researchers want to study how certain markers in the blood predict the severity and outcome~     of acute GVHD and how ECP treatments work for people with acute GVHD. They will also study~     how these markers in the blood may help predict who should get ECP and its effects on the~     immune system.~      <TAB>~      Objectives:~      - To learn more about treatments for acute GVHD after allogeneic stem cell transplantation.~      Eligibility:~      - Adults with acute GVHD enrolled in an NCI allogeneic transplantation protocol.~      Design:~        -  Transplant physicians will confirm participant eligibility.~        -  Participants will receive treatment with steroids for their acute GVHD as prescribed by~          their transplant physician. This will continue while they are enrolled on this study.~        -  If steroids work in treating their acute GVHD, then every 28 days for 6 months,~          participants will have:~        -  a physical exam.~        -  blood tests.~        -  If steroids do not work, participants will get additional treatments as prescribed by~          their transplant physician who may choose to use ECP as a part of this additional~          treatment.. For ECP, blood is removed through an intravenous (IV) catheter. A machine~          separates the white blood cells from the other blood parts. Those cells are treated~          with methoxsalen and exposed to ultraviolet light. Then they are returned to the~          participant through their IV.~        -  Participants who get ECP will over at least 6 months have:~        -  veins researched. They may have a catheter placed in a larger vein in the chest or~          groin.~        -  multiple blood tests.~        -  multiple pregnancy tests (if needed).~        -  multiple ECP procedures.~        -  At the end of ECP treatment and 6 months after ECP, participants will have additional~          physical exams and blood tests.~   "
56148|NCT02322177|"~     Background:~      - People with inborn errors of metabolism can t turn food into energy the right way. This~     can affect a person s growth and health. Researchers want to know how this condition affects~     a pregnant woman and her baby.~      Objectives:~      - To collect data from the medical records of women with an inborn error of metabolism.~     Also, to create a pregnancy registry of inborn errors of metabolism.~      Eligibility:~        -  Women with an inborn error of metabolism who either:~        -  have been pregnant in the past,~        -  are currently pregnant, or~        -  have recently talked with their doctor about becoming pregnant.~      Design:~        -  This study will collect data only. No extra tests will be done.~        -  Participants will be in the study for the length of their pregnancy and for 1 year~          after delivery.~        -  Participants will answer questions about their family s health.~        -  The participant s doctor will send their medical records to researchers. These may~          include data about:~        -  Last health care visit before pregnancy~        -  Blood, urine, ultrasound, or lab results during pregnancy~        -  Delivery and recovery after delivery~        -  Researchers will ask for the test(s) used to confirm pregnancy.~        -  After the participant has her baby, researchers will ask for data about how the baby is~          doing. This may include when the baby is sitting, walking, talking, etc.~        -  The data will be placed into a database. The database will not include the participant~          s name or identifying data.~   "
56149|NCT02322164|"~     Background:~      - Researchers are studying a topical (skin) cream that reduces pain. This is called an~     analgesic cream. They want to try a new test to better measure how well it works. Heat will~     be applied to the participants arms and they will judge the intensity of the temperatures.~     Researchers will compare the pain reduction from this cream to other pain relief treatments.~      Objective:~      - To better measure the effects of a pain-relieving (analgesic) cream.~      Eligibility:~      - Healthy volunteers ages 18 50.~      Design:~        -  There will be 2 study sessions.~        -  Session 1 will be about 1.5 hours.~             -  Participants will be screened with physical exam and urine drug test. They will~               answer medical and psychological questions.~             -  Participants will have sensory testing.~        -  A moisturizer will be put on their arms. A heating device will be placed on their arms.~          It gives heat pulses of about 2 seconds each. Some are warm and some are very hot.~          Participants will say how strong each pulse is. They can move away if it gets painful.~        -  Then the pain-relieving cream will be put on one arm. The moisturizer will be put on~          the other. Participants will get more pulses and rate them. They will also get pairs of~          pulses and compare them.~        -  Some participants will return for session 2 for 1 hour. They will receive similar~          sensory testing as in session 1.~   "
56157|NCT02322060|"~     In this study, the investigators used the newly developed technique i.e. in vitro activation~     of dormant follicles (IVA) to promote ovarian follicle growth much more efficiently than~     natural, in vivo process for women with Primary Ovarian Insufficiency (POI).Firstly, the~     investigators remove one ovary under laparoscopic surgery. Then, we dissect ovarian cortex~     from the ovarian medulla. The ovarian cortex is cut into small cubes and cultured with~     medium containing drugs to activate dormant follicles. After 2 days of culture, the ovarian~     cubes are transplanted mainly beneath the membrane of Fallopian tubes under laparoscopic~     surgery. The ovarian cortex could be cryopreserve for future re-transplantation and in some~     cases, for convenience to arrange second surgery. Once frozen, the ovary can be preserved~     semipermanently. After transplantation, patients receive ultrasound monitoring together with~     measurement of serum hormone levels for 10-12 months. If growing follicles are detected,~     follicle growth is stimulated by injection of hormones (gonadotropins). Using the same ovum~     pick up approach used in IVF (in vitro fertilization), we pick up oocytes from the~     follicles and fertilize them. Fertilized eggs are cultured and then cryopreserved for future~     embryo transfer.~   "
63221|NCT02229760|"~     To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on~     intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate~     (CBV-TP) and plasma viral load~   "
56150|NCT02322151|"~     Background:~      - The drug filgrastim (rGCSF) increases the number of blood-forming cells in the~     bloodstream. These cells can be collected from donors bloodstreams and used for transplant.~     Studies have shown that rGCSF is present in the breast milk of nursing mothers who are~     taking it. Based on these studies, it is now recommended that a nursing mother should not~     breastfeed from the time she receives the first dose of the drug until 2 days after the~     final dose. Researchers want to study the amount of the drug and its effect on the cells~     present in donor blood and breast milk. They hope to better understand the effects of this~     drug on breast milk.~      Objectives:~      - To understand the effects of filgrastim on breast milk.~      Eligibility:~      - Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.~      Design:~        -  Participants will receive rGCSF daily for 5 days. They will have blood taken daily.~        -  Participants will get a freezer bag containing 10 sterile, labeled containers for~          breast milk collection.~        -  Participants will transfer some of the breast milk they pump into one of the~          containers. They will write the date and time the milk was collected on the container.~          They will freeze the samples. Any remaining milk should be disposed of.~        -  Participants will bring the samples to NIH on the day of their stem cell collection~          procedure.~        -  For days 1 and 2 after stem cell collection, participants will continue to collect and~          freeze breast milk samples and dispose of any remaining milk.~        -  For days 3 5 after stem cell collection, participants will collect and freeze samples.~          They can also resume normal breastfeeding.~        -  A research nurse will arrange to collect the samples.~   "
56151|NCT02322138|"~     The study objective is to evaluate the gastrointestinal tolerance of infant formula~     supplemented with prebiotics.~   "
56152|NCT02322125|"~     Powered exoskeletons have emerged recently, promising to offer walking to individuals with~     severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to~     train walking in individuals with chronic, severe spinal cord injury. We will determine the~     characteristics of individuals who most benefit from such training, and identify the~     neuroplasticity induced by the training. We will further determine the feasibility of the~     ReWalk for home and community ambulation.~   "
56153|NCT02322112|"~     Too much body-fat has been linked to a low-grade inflammation throughout the body. This~     inflammation is thought to then cause different diseases, like heart disease and diabetes. A~     lower amount of inflammation is usually seen in people that follow a high fiber diet. A~     reason for this is the microbes that live in our gut. Fiber is a main food source for these~     microbes. This allows fiber to actually change the type of microbes that live in our gut.~     Also, when fiber gets fermented by these microbes, health-promoting waste products get~     released. We aim to determine how exactly our gut microbes contribute to the health~     properties of fiber.~      We hypothesize that fiber's health properties depend on how the gut microbes respond to the~     fiber. To test this, we plan to add three different fibers to the diets of healthy~     overweight and obese individuals for six weeks. We then will determine how the different~     fibers affect an individuals' health by looking at how established markers of health change~     from adding the fiber. Following this, we will see how an individual's gut microbes respond~     to the added fiber. The response will be decided by looking at changes to the microbe~     community, as well as their ability to ferment the fibers. By connecting health outcomes to~     the gut microbes' response, we can test if the gut microbes' response to the fiber~     determines the fiber's ability to effect health. If we can understand how our gut microbes~     respond to different fibers and the importance of that response. Then we could personalize~     diets to have a greater impact on improving health.~   "
56154|NCT02322099|"~     Antiretroviral therapy (ART) initiation is associated with a significant loss of bone~     mineral density (BMD), characterised by increases in bone turnover, which is largely limited~     to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone~     turnover and can limit loss of bone mineral density.~      This study aims to determine if a short course of treatment with the oral bisphosphonate~     alendronate can limit loss of bone mineral density associated with initiation of ART in~     HIV-1 infected, antiretroviral naive, adult subjects.~   "
56155|NCT02322086|"~     This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply~     PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28~     consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding~     palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be~     collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days~     29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of~     application of active PH-10 on Day 36. Study data from each subject will serve as an~     internal control (i.e., assessment at baseline and at the end of application of PH-10~     vehicle) for assessment of clinical and cellular response to active investigational agent.~   "
56156|NCT02322073|"~     Visceral obesity and adipose inflammation is considered a driving force of obesity-related~     systemic disease, e.g. liver cirrhosis and chronic kidney disease (CKD). Inflammatory~     resolution is actively regulated by specialized pro-resolving mediators (SPMs), including~     the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of~     obesity-related pathology.We hypothesize that obese patients who develop obesity-related~     liver and kidney disease do so because they suffer from impaired endogenous production of~     pro-resolving lipids. This will result in aggravated adipose inflammation, which causes~     systemic pathologies such as kidney disease. We thus wish to investigate adipose~     inflammation and the pro-resolving lipid profile of obese subjects with and without CKD and~     liver disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory~     agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo~     tissue culture.~   "
56173|NCT02321852|"~     The purpose of this study is to investigate the effects of the eNOS activating agent~     triflusal on episodic memory and cognitive functions in healthy participants.~   "
56174|NCT02321839|"~     To evaluate the visual outcome, number of injections and visits, and the effect of mental~     status of a treat and extend regimen in managing neovascular age-related macular~     degeneration with intravitreal ranibizumab.~   "
56175|NCT02321826|"~     The aim of this study is to determine the effect of listening to music on sleep quality~     (subjective and objective), daytime dysfunction and neurophysiological arousal in patients~     with insomnia.~   "
56158|NCT02322047|"~     The purpose of this study is to see whether the drugs prazosin and naltrexone will decrease~     alcohol cravings and drinking in individuals who have problems with alcohol and have used~     alcohol at risky levels in the past 90 days.~      Prazosin is a medication that is FDA approved for treating people with high blood pressure.~     Some studies have shown that prazosin may also decrease nightmares and improve sleep in~     Veterans suffering from Posttraumatic Stress Disorder (PTSD). The use of prazosin for PTSD~     nightmares is an off-label use. That means that the FDA has not approved prazosin for PTSD~     nightmares. The current study is evaluating an off-label use of prazosin to determine~     whether it is helpful in decreasing alcohol cravings and consumption among people with~     alcohol problems.~      Naltrexone is a medication that is FDA approved for treating alcohol problems.~      This study is sponsored by the Department of Defense and the Congressionally Directed~     Medical Research Program (DoD/CDMRP). We expect approximately 240 participants in this~     study, which will run over approximately 4 years. Study participants will be involved in the~     study for 7 weeks, or until they complete the Final Assessment.~   "
56159|NCT02322034|"~     The investigators aim at investigating whether 24-week high intensity interval training~     might exert beneficial effects by modulating neurohormonal axis in patients with chronic~     heart failure (CHF). Furthermore, the effect of detraining on neurohormonal axis in CHF~     patients will be evaluated.~   "
56160|NCT02322021|"~     This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive~     Impairment due to Alzheimer's Disease/Prodromal Alzheimer's Disease (referred to as~     MCI/Prodromal) and mild to moderate dementia due to Alzheimer's Disease (referred to as mild~     to moderate AD).~   "
56161|NCT02322008|"~     Can genetic markers be used to predict anti-TNF response? A cohort was established to~     identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.~   "
56162|NCT02321995|"~     This study aims to evaluate the Zenalux IM1, an optical spectroscopy device with a pressure~     sensor. The pressure sensor is intended to overcome the inconsistencies attributable to~     variations in use of the device. This study will involve using the device on healthy~     volunteers. Three tissue parameters will be used to analyze the pressure effects in two~     ways: within- and across-subject variability. Measurements will be taken under the tongue~     and on the inside of the cheek. The device is noninvasive and is approved for preclinical~     use.~   "
56163|NCT02321982|"~     The purpose of this study is to determine whether separate- versus same-day preoperative~     consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of~     case cancellations, cost, and patient satisfaction. The investigators hypothesize that~     patients with same-day preoperative consultation will have a shorter time between cancer~     diagnosis and removal but, only when coordination of care is needed, longer time between~     removal and consultation with other specialists, as compared to patients with separate-day~     consultation. The investigators anticipate that patients with same-day preoperative~     consultation will have a decrease in travel cost as compared to patients with separate-day~     consultation. The investigators expect that there will be no difference in various~     satisfaction matters between groups, with the exception of potentially greater convenience~     reported by patients in the same-day preoperative consultation group. Finally, the~     investigators hypothesize that there will be no difference between groups in regards to~     rates of surgery cancellation.~   "
56164|NCT02321969|"~     Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on~     colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of~     this study is to determine the preventive effect of GTE supplements on metachronous~     colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per~     day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).~   "
56165|NCT02321956|"~     The purpose of this study is to determine whether ultrasound study of the airway to predict~     endotracheal tube size in anesthetized pediatric patients better than the tube size formula~   "
56166|NCT02321943|"~     The objective of this study is to explore the longitudinal course of self-disturbances (SD)~     in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a~     representative sample of patients with first-episode schizophrenia, bipolar disorder and~     other psychoses. The overall aim is to expand our knowledge about the role of SDs in~     psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current~     study is a seven year follow-up of this representative cohort, with baseline measures of SDs~     and a comprehensive clinical and neurocognitive assessment battery.~   "
56167|NCT02321930|"~     This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker~     disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and~     whether early MSUS measures/MBDA can predict response to therapy.~   "
56168|NCT02321917|"~     In this study, the investigators would like to compare a heparin-coated tubing system for~     minimized extracorporeal circulation (MECC) with the conventional tubing system for MECC,~     which does not contain heparin coating. The MECC system has been used since 14 years in the~     investigators' hospital as an extracorporeal system to support circulation and provide~     oxygen to the tissues during coronary artery bypass grafting. Until today, the investigators~     performed more than 5000 MECC procedures in their department.~   "
56169|NCT02321904|"~     The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM)~     as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in~     children. This study will be divided into two phases: Phase 1 will be a cross-sectional~     study of children with type 1 diabetes and normal controls, while phase 2 will be a~     longitudinal assessment of a subgroup of children with type 1 diabetes recruited during~     Phase 1.~   "
56170|NCT02321891|"~     The investigators examine the efficacy of two different transcranial direct current~     stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot~     study.~   "
56171|NCT02321878|"~     This trial is conducted in Asia. The aim of this trial is to evaluate safety and~     effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination~     with antidiabetes agents other than sulfonylurea under post-marketing normal clinical~     practice conditions.~   "
56172|NCT02321865|"~     The objective of this study is to check the dose control method of NPC-02 and the holding~     effect for the target serum zinc concentration in patients with zinc deficiency.~   "
56178|NCT02321787|"~     The purpose of our study is to evaluate whether utilizing ultrasound assessment during~     caudal epidural injection can reliably identify unrecognized and unsuccessful nerve blocks~     during the procedure, guide proper technique, and alter pain management outcome measurements~     for patients.~      Patients will be randomized to a group either undergoing caudal injection by a trainee using~     typical techniques or by using typical techniques in addition to ultrasound for confirmation~     of successful injection. The patients enrolled in this study will have the same~     intraoperative care, in line with the standard of care. Data will be collected~     intraoperatively and postoperatively on pain scores, time for performance of caudal block,~     and perceived success of the block. There will be no direct benefit to the patients enrolled~     in this study, but future patients may benefit from the use of ultrasound for the~     confirmation of a successful block.~   "
56179|NCT02321774|"~     Monitor stress response in a virtual reality environment using a wearable sensor to analyze~     and track heart rate variability (HRV).~   "
56180|NCT02321761|"~     Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who~     suffered Acquired Brain Injury in order to expedite recovery and improve functioning.~      A previous study examined the spatially asymmetric allocation of attention in patients with~     traumatic brain injury (TBI). Patients demonstrated significantly worse performance with~     leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of~     neglect patients. This difference was significantly reduced during and following treatment.~     Our objective is to investigate whether Amantadine Hydrochloride is effective in improving~     allocation of spatial attention and improving function in people with Traumatic Brain~     Injury.~   "
56181|NCT02321748|"~     CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo~     the inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions.~     The aim of this trial is to investigate the potential for interaction of ASP2151 with the~     CYP2C8 probe substrate montelukast.~   "
56182|NCT02321735|"~     : Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers;~     however, some advanced-stage ovarian cancer patients are long-term survivors. These patients~     may provide the key to long-term survival and bring hope to all women with Stages III and IV~     ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer~     become long-term survivors and what their quality of life is long after their initial~     diagnosis. This research project will specifically determine molecular features within~     tumors along with genetic, quality of life, and lifestyle features that predict for~     long-term survival for patients with Stages III and IV ovarian cancer. It will bring~     together sophisticated molecular techniques, researchers with longstanding interest, a wide~     spectrum of consumer advocates (a number being long-term survivors), and quality of life~     experts to analyze the most carefully maintained patient database in the world—the~     Gynecologic Oncology Group database. We anticipate the results from this project will~     identify specific biochemical pathways and genetic features associated with long-term~     survival that can be used to improve the treatment, survival, and survivorship of patients~     with this disease. There is clearly something unique among patients who survive Stage III or~     IV ovarian cancer long term, and we believe that when we understand what this is, we can~     increase the number of long- and longer-term survivors.~   "
56183|NCT02321722|"~     Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed~     and treated properly. The major risk factor for the development and progression of glaucoma~     is increased intraocular pressure. Colonoscopy is one of the most preformed world wide~     screening exam. It is used to detect colon cancer at its early stages. As part of this~     examination, the examiner inflates the inspected colon with air in order to increase the~     colon lumen for better visualization of the colon. As a consequence of the insufflation the~     intrabdominal pressure increases as well. the increase in intrabdominal pressure could~     increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure~     increase while preforming colonoscopy.~   "
56184|NCT02321709|"~     Primary Objective:~      To assess the tolerability and safety of SAR113244 in male and female lupus patients after~     every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.~      Secondary Objectives:~      To assess in male and female lupus patients:~        -  The pharmacokinetics of SAR113244.~        -  The pharmacodynamics of SAR113244 for the following disease-related parameters:~             -  Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus~               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus~               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus~               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index~               (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of~               Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic~               acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma~               complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive~               protein.~             -  Peripheral blood B and T cells subsets.~   "
56185|NCT02321696|"~     Work-related upper extremity disorders are common problems in working populations in western~     countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft~     tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000~     patients in general practice, and as high as 15 % of workers in highly repetitive hand task~     industries.~      LE is a painful condition, leading to loss of function of the affected limb. Therefore it~     can have a major impact on the patient's work and personal life. If untreated, it persists~     for an average of six to 24 months and associated with significant sickness absence in 5 %~     of affected working-aged adults. The cost is therefore high, both in terms of loss of~     productivity and health care utilization.~      Many treatments have been advocated in the management of LE, possibly implying that much is~     unknown about its etiology and how it best should be treated. Systematic reviews have failed~     to draw any firm conclusions as to what treatment is most effective in managing this~     condition.~      Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both~     clinicians and consumers of health, and there is some evidence suggesting that acupuncture~     treatment is effective in of acute symptoms in LE. A recent study supports that also elbow~     manipulation have a short-term relief of acute symptoms in LE, especially when combined with~     eccentric exercise. Our study will therefore explore the clinical effectiveness of~     physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.~   "
56189|NCT02321644|"~     This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of~     multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics~     of single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the~     minimum amount of UV-B light that causes minimally perceptible skin reddening. This will~     take place before dosing (baseline) and 3 times more while on increasing doses of CC-90001.~     Punch biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase~     activity. Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of~     CC-90001 when administered in the fasted state and after a high-fat meal.~   "
56190|NCT02321631|"~     The purpose of this study is to study the effects of EPA-enriched supplement compared with~     conventional supplement in malnourished head and neck cancer patients undergone surgery.~     Primary outcome is perioperative weight changing.~   "
56191|NCT02321618|"~     African-American men suffer more than most other groups from hypertension (HTN) but often~     have less access and less contact with doctors. Previous work by the study's Principal~     Investigator in Dallas, Texas, and Altadena, California, showed that barbershops are an~     excellent place to identify black men with high blood pressure and to enlist the aid of~     their barbers as healthcare extenders.~      The purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based~     patient-centered blood pressure programs to see which type is more effective in improving~     the customers' high blood pressure. One type emphasizes blood pressure medication and the~     other type emphasizes lifestyle modification for high blood pressure.~   "
56192|NCT02321605|"~     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best~     Possible Self) over optimism, future expectancies and positive affect at mid-term, in~     comparison to a control group. The principal hypothesis is that Best Possible Self~     intervention will enhance significantly the levels of optimism and positive affect in~     comparison to the control group at short and mid-term.~   "
56193|NCT02321592|"~     The study is designed~        -  to demonstrate efficacy of AFM13 with an optimized treatment schedule~        -  to decide whether AFM13 warrants further investigation in a phase III clinical trial~   "
56194|NCT02321579|"~     This study is designed as a hospital-based cross-sectional and randomized placebo-controlled~     intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis~     combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be~     recruited from Taichung General Veterans Hospital. One hundred patients will be randomly~     assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25);~     3) glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500~     mg/d) group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be~     collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood~     drawn in the clinics. Additionally, patients who participated in the intervention study will~     have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological~     measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine,~     SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme~     activities will be analyzed.~   "
56195|NCT02321566|"~     This study is an open-label study to determine the feasibility of Motor Cortex Stimulation~     (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS~     will be delivered by use of an electrode and pulse generator, which are FDA approved for~     spinal cord stimulation but are not approved for MCS. The study has as a single-arm design~     with the subject at baseline serving as a control for the response to MCS.~   "
56196|NCT02321553|"~     The purpose of the study is to determine the effect of consumption of brown rice on the risk~     factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and~     white rice will be provided in the form of rice cakes and 100g will be consumed per day for~     5 weeks each. The investigators hypothesize that brown rice will have beneficial effects as~     it is rich in fiber and also phytochemicals.~   "
56197|NCT02321540|"~     The goal of Part 1 of this clinical research study is to find the highest dose of~     (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC).~     The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib~     found in Part 1 can help to control the disease.~      The safety of this drug will also be studied in both parts of the study.~   "
56198|NCT02321527|"~     The goal of this clinical research is to learn if an ultrasound contrast agent called~     OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before~     surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph~     node is the first node that may be the target of cancer cells that spread from the tumor.~   "
56199|NCT02321514|"~     The purpose of this study is to generate initial insights into the safety and performance of~     the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral~     regurgitation who are not suitable candidates for conventional mitral valve repair or~     replacement. The study will include up to 110 subjects at up to 30 centers. Follow-up~     evaluations will be conducted through 2 years post implantation.~   "
56200|NCT02321501|"~     The goal of this clinical research study is to find the highest tolerable dose of ceritinib~     (LDK378) and everolimus that can be given to patients with NSCLC or head and neck cancer.~     The safety of the drug combination will also be tested.~   "
56201|NCT02321475|"~     The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in~     Russian patients of middle age and younger, suffering from psycho-emotional symptoms added~     to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood~     test) score.~   "
56202|NCT02321462|"~     The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the~     reference colonic lavage in Russia) administered in adult subjects scheduled to undergo~     colonoscopy for a routinely accepted diagnostic indication.~   "
56203|NCT02321449|"~     To evaluate the effectiveness of treatment with Circadin based on sleep improvement as~     assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before~     and after the treatment~   "
56204|NCT02321436|"~     The purpose of this study is to investigate if early administration (i.e. within 12 weeks~     after stroke) of Dysport® 500 U injections may delay the appearance of the progression of~     upper limb symptomatic spasticity.~   "
56205|NCT02321423|"~     International Pachyonychia Congenita Research Registry (IPCRR) is a patient registry for~     those suffering from Pachyonychia Congenita (PC). PC is an ultra-rare extremely painful skin~     disorder that causes painful blisters and callus on feet and sometimes hands, thickened~     nails, cysts and other features. The IPCRR consists of a questionnaire, patient photos,~     physician notes from telephone consultation to validate questionnaire, free genetic testing.~   "
56206|NCT02321410|"~     Atherosclerosis may initiate early in life and takes years to progress. This contrasts to~     the abrupt coronary or cerebrovascular events occurring following the transition from a~     stable to an unstable atherosclerotic plaque. The causes of this discontinuity of the~     disease are complex and probably multiple. There is increasing evidence that, besides~     inflammation, neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages~     play an important role in plaque instability ending-up frequently in acute thrombotic~     occlusion or distal embolisation of athero-thrombotic material associated with heart attack~     or stroke. Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows~     to enhance microvascular structures and to visualize the adventitia and intraplaque~     vascularization. Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been~     evaluated for in vivo detection and quantification of plaque neovascularity. Together with~     the presence of a large lipid-rich core, thin fibrous cap, positive remodeling and active~     inflammatory infiltrate, plaque neovascularisation is considered a valid marker of high-risk~     (or vulnerable) plaque as demonstrated in histopathological studies using microvessel~     density.~      Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS),~     a bed-side technique, in detecting plaque neovascularisation and compare it with the~     quantitative assessment by DCE-MRI in carotis atherosclerosis.~      A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler~     ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and~     DCE-MRI will be performed in the same patients and will be analyzed by two separate~     operators blinded to the results of the CEUS in order to detect the efficacy of CEUS when~     compared with in vivo DCE-MRI, as the standard of reference.~   "
56207|NCT02321397|"~     This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR~     tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the~     same overall daily dose.~   "
56208|NCT02321384|"~     This study is a single-center, double-blind, randomized, placebo-controlled,~     single-ascending dose (SAD) and multiple-ascending dose (MAD) study that will evaluate the~     safety, tolerability and pharmacokinetics (PK) of RO6889678 following oral administration in~     healthy volunteers.~      Healthy participants will be screened up to 28 days before randomization and sequentially~     enrolled into SAD and MAD cohorts, then randomly assigned to RO6889678 or matching placebo.~     To explore the effect of food on RO6889678 PK, a cohort of volunteers will participate a~     two-period food effect substudy. Participants enrolled in the MAD cohorts will be given an~     oral microdose of midazolam before and after the repeat treatment to evaluate the drug-drug~     interaction potential of RO6889678.~   "
56209|NCT02321371|"~     In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE~     (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the~     fulfilment of inclusion/exclusion criteria and consent of the patient's attendants.~     Investigation of the patient (as mentioned in the proforma) will be done.~      Intervention step 1:~      liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema~     3rd hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly~     (If patient has no bowel sounds, only enema will be given)~      Intervention step 2:~      (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL)~     Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose +~     addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only)~     Continuation of Lactulose therapy for further 48 hours.~   "
56210|NCT02321358|"~     This trial is a three-armed randomized controlled trial which will explore the utility of an~     implementation intention intervention on aerobic and resistance exercise in older (60+)~     prostate and breast cancer survivors and improving quality of life. It is expected that~     those in the experimental groups will report greater increases in their physical activity,~     resulting in greater improvements in their quality of life.~   "
56211|NCT02321345|"~     This is a feasibility study of pre-transplant involvement of a palliative care provider in~     the setting of HCT. Although this is primarily a feasibility pilot, the investigators will~     explore how patients are affected by the palliative care meetings as well as test data~     collection mechanisms that would be used in a future randomized clinical trial.~      The investigators hypothesis is that patients will be amenable to pre-transplant involvement~     of the palliative care team and might welcome the chance to discuss palliative care issues~     separate from the primary team. Palliative care providers also have special training and~     experience in conducting these interactions and expertise in supportive care practices. They~     will be available should a patient's condition become life- threatening. This study is~     therefore designed primarily to evaluate the level of comfort / distress of patients when a~     palliative care consultation and follow-up are integrated into their care.~   "
56212|NCT02321332|"~     Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic~     sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory~     hyperhidrosis.~   "
56213|NCT02321319|"~     This pediatric study is designed to provide safety information, dosing guidelines, and a~     pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl)~     extended-release (ER) tablets in children with chronic painful conditions who are~     opioid-tolerant prior to enrollment under the Pediatric Research Equity Act (PREA) of~     2003.~   "
56214|NCT02321306|"~     Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to~     evaluate the long-term safety and tolerability of daily dosing with LUM001.~   "
56215|NCT02321293|"~     The purpose of this study is is to assess the safety and tolerability of curcumin in~     combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR~     NSCLC.~   "
56227|NCT02321137|"~     The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of~     surgical closure of LAA in patients undergoing aortic valve replacement. This randomized,~     prospective, open-label international multicenter trial will enroll 1040 patients undergoing~     aortic valve replacement with CHA2DS2-VASC score ≥2 but without an indication for~     anticoagulation at the time of enrollment. Patients will be randomized in 1:1 fashion to~     standard therapy + surgical closure of LAA vs. standard therapy alone. The duration of the~     study is five years (plus additional 10 years).~   "
56243|NCT02320929|"~     This study evaluates the effect of postoperative intermittent closed-catheter irrigation on~     the recovery from the purulent flexor tenosynovitis. One group of patients suffering from~     acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the~     other group having both intra- and postoperative irrigation.~   "
56216|NCT02321280|"~     Denosumab, a fully human monoclonal antibody to RANKL was approved for the treatment of~     postmenopausal osteoporosis in June 2010. It is administered subcutaneously once every 6~     months and is highly effective in reducing the risk of vertebral, non-vertebral, and hip~     fracture risk. There are 3 main concepts underpinning the rationale for using Denosumab to~     treat CD.~        1. CD is associated with an increased risk for osteoporosis and the biology of~          osteoporosis and T cell mediated inflammation, thought to be integral in CD, involve~          the RANKL paradigm~        2. Animal models of bone loss and colitis treated with RANKL inhibitors improve both bone~          mass and colitis. A dinitrofluorobenzene sulfonic acid (DNBS) model of colitis in our~          lab showed significant improvement with Denosumab treatment compared to vehicle~          (saline) treatment.~        3. CD is associated with an increase in mutations at the locus that encodes for RANKL The~          investigators are conducting an open label pilot study of single dose Denosumab 120 mg~          s.c. to patients with active Crohn's disease, with assessment of clinical response and~          remission at 12 weeks.~   "
56217|NCT02321267|"~     Macular diseases often cases severe visual impairment. Recent clinical introduction of~     anti-vascular endothelial growth factor agents may change the clinical course of various~     macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal~     vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous~     chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion~     (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual~     outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH),~     vitreomacular traction syndrome (VMTS).~      Patients with such macular diseases are registered and are followed up for 5 years with~     appropriate treatment for each patient. By the analysis of the correlation between initial~     examinations and final visual acuity, factors associated with good visual prognosis will be~     elucidated.~   "
56218|NCT02321254|"~     The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to~     determine the feasibility of including robotic therapy in daily rehabilitation programmes,~     after stroke. Additionally, we aim to investigate the acceptance of this intervention from~     patients and therapists. A total of 10 patients will be recruited in this study, all the~     patients will receive 1 hour of standard therapy together with 45 min of robot therapy every~     day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period~     of four weeks. Additional 15 minutes are required for placing surface electrodes on the~     shoulder and patient preparation. The study will include passive and active shoulder~     training of four movements: Horizontal abduction/adduction, abduction/adduction,~     internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the~     active part 35 minutes.~   "
56219|NCT02321241|"~     The aim of the TITAN study is to describe the clinical practices of a cohort of patients~     with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid)~     who switch to aflibercept after less than 12 months of ranibizumab treatment.~      The study will be conducted in real-life conditions and will allow describing conditions of~     use of aflibercept in patients refractory to ranibizumab~   "
56220|NCT02321228|"~     The purpose of this study is to determine whether an innovative preventive strategy,~     consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy~     beyond current guideline age, improves menopause-related quality of life without~     significantly increasing ovarian cancer incidence in comparison to current standard~     salpingo-oophorectomy in female BRCA1/2 mutation carriers.~   "
56221|NCT02321215|"~     The purpose of this study is to determine if it is effective and feasible to provide a~     chronic obstructive pulmonary disease (COPD) education program to patients admitted with an~     acute exacerbation of COPD.~   "
56222|NCT02321202|"~     The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy~     is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition~     improved postoperative recovery for cirrhotic patients with liver cancer underwent~     hepatectomy..~   "
56223|NCT02321189|"~     Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal~     thickness of the young participant using SD-OCT to see the effect of Resveratrol Based~     Nutritional Supplement on Choroidal Thickness.~   "
56224|NCT02321176|"~     There is blood-eye barrier in eyes,but some oral medicines can enter in the tissues of eyes.~      The primary objective of the study is to study the Pharmacokinetics of Trans-resveratrol and~     Its three Metabolites in Human Eyes and Blood~   "
56225|NCT02321163|"~     Objectives: This study aims to examine the use of low frequency (2Hz), low amplitude~     (intensity just produce visible muscle contraction), and long duration (2x3 hrs/day)~     neuromuscular electrical simulation (NMES) in attenuating the effects of muscle atrophy~     resulted from disuse.~      Design and subjects: The study is a randomized, double-blind, controlled, and parallel group~     study. Subjects with stable chronic obstructive pulmonary disease (COPD) will be included.~     Intervention: Subjects will be randomized to 3 groups to receive different NMES program over~     the quadriceps and calf muscles: (i) the proposed NMES program; (ii) conventional NMES~     program (50Hz, 30 min/day), or sham group for a period of 8 weeks.~      Outcome measures:The effectiveness of the NMES will be evaluated by the improvement in~     muscle cross-sectional area (CSA), muscle performance (muscle strength, muscle shortening~     velocity and muscle activation testing), functional performance (6 min walk) and subjects'~     rating of the perceived acceptability of the stimulation protocol.~      Data analysis: Baseline characteristics of the intervention and sham groups will be compared~     using one way ANOVA. Two-way mixed repeated measures analysis of variance will be performed~     to examine the differences between groups over time for all the outcome variables. The~     significance level is set at p < 0.05.~      Expected results: The investigators hypothesize that the proposed new paradigm of NMES would~     be more effective in improving muscle cross-sectional area (CSA), strength, endurance, and~     exercise tolerance.~   "
56226|NCT02321150|"~     The aim of this study is to introduce a new surgical technique for the removal of pterygiums~     that entails the use of bipolar electrocautery to secure the graft, rather than sutures.~      With this, the objective is to evaluate the benefits of a new technique for pterygium~     surgery with respect to postoperative patient comfort, surgery time, cost and recurrence~     rate.~   "
56286|NCT02320370|"~     The investigators examine the efficacy of two different transcranial direct current~     stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label~     pilot study in patients who have faced severely stressful life events.~   "
56228|NCT02321124|"~     Connective tissue manipulation (CTM) is a manual reflex therapy, which increases intestinal~     motility by stimulating autonomic nervous system to re-balance the parasympathetic and~     sympathetic functions. However, there is no randomized controlled trial (RCT) regarding the~     efficacy of CTM on constipation. This study was planned to investigate the effects of CTM in~     patients with chronic constipation.~      Patients who have diagnosis of chronic constipation according to Rome III criteria were~     recruited and randomized to intervention and control group. The intervention group received~     CTM in addition to the lifestyle advice, while the control group was given only lifestyle~     advice for constipation. All assessments were performed at baseline and at the end of 4~     weeks. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary~     outcomes included Patient Assessment of Constipation Quality of Life Questionnaire~     (PAC-QOL), Bristol Stool Scale (BSS) and 7-day bowel diary. Differences between groups were~     analyzed with t-tests, Mann-Whitney U test and Chi-square test.~   "
56229|NCT02321111|"~     The purpose of this study is to determine whether pharmacologic inhibition of Toll-like~     receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin~     resistance in lean, normal glucose tolerant (NGT) subjects.~   "
56230|NCT02321098|"~     The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail~     Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment~     of mild to moderate toenail Distal Subungual Onychomycosis.~      The second objective of this study will be photographic follow-up of clinical improvement~     and cure after the initial treatment period of 12 weeks, for 15 additional months.~   "
56231|NCT02321085|"~     Prospective randomized (rhythm control or rate control in heart failure patients with new~     onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients~     with heart failure with new onset atrial fibrillation according to the rhythm control 2. To~     analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3.~     To analyze the change of LV function and functional capacity according to the rhythm in~     patients with HF and new onset AF~   "
56232|NCT02321072|"~     Objectives:~        1. To study the short- and long-term effect of two different PaO2 targets on circulatory~          status, organ dysfunction and outcome in patient admitted to the ICU with Systemic~          Inflammatory Response Syndrome (SIRS) criteria.~        2. To study underlying mechanisms of hyperoxia by determining differences in oxidative~          stress response between the hyperoxic and the normoxic patients.~      Study design:~      Randomized, prospective multicentre clinical trial~      Study population:~      Patients admitted to the Intensive Care unit with ≥ 2 positive SIRS-criteria and an expected~     ICU stay of more than 48 hours~      Intervention:~      Group 1: target PaO2 120 (105 - 135) mmHg (high-normal)~      Group 2: target PaO2 75 (60 - 90) mmHg (low-normal)~      Primary endpoints:~      The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14.~   "
56233|NCT02321059|"~     Patients with an incisional hernia in the midline and controls with an intact abdominal wall~     are examined twice with one week apart, in order to establish the test-retest reliability~     and internal and external validity of the Goodstrength trunk dynamometer.~   "
56234|NCT02321046|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative oncology departments / institutions in order to determine the prevalence of~     EGFR mutations in treatment-naive Russian patients with cytologically verified advanced~     NSCLC in Russia.~   "
56235|NCT02321033|"~     Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on~     changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to~     detraining.~      The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced~     impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.~   "
56236|NCT02321020|"~     The present study aimed at evaluating mid-term results of radiofrequency modified maze~     procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration~   "
56237|NCT02321007|"~     The purpose of this study is to establish a tissue and data repository consisting of samples~     of human placentas, umbilical cord blood, and maternal blood, collected at the time of~     delivery. Specimens will be used in cellular, molecular, and functional studies to learn~     more about changes in placental structure and function, which can result in serious~     pregnancy complications and determine life-long health by programming the fetus for future~     metabolic and cardiovascular disease.~   "
56238|NCT02320994|"~     In this first step of the study the investigators will assess the needs, disease burden and~     current treatments of long-term stroke patients (phase MAS-I).~      The ultimate aim of the complete MAS project (MAS I, II & III) is the development of a model~     of stroke aftercare delivery that can be evaluated to estimate effects in both our local and~     the wider stroke population.~   "
56239|NCT02320981|"~     Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower~     esophageal impedance measurements when compared to patients how do not have GERD or EE.~   "
56240|NCT02320968|"~     This study is designed to determine if the addition of the MedclineTM Sleep Assist Device~     will decrease night-time gastroesophageal reflux disease events.~   "
56241|NCT02320955|"~     The complications after reimplantation of cryoconserved autologous bone flaps are reported~     inhomogeniously in the literature. Especially the incidence of bone flap resorption varies~     from 0% to about 30%. More recent retrospective studies seem to find higher resorption rates~     and thus suggest to implant artificial bone replacements from the start. The Swiss~     Prospective Autologous bone Resorption Study is the first propspective observational study~     designed to determine the true incidence of autologous bone resorption.~   "
56242|NCT02320942|"~     This study is a preliminary study to assess whether it is possible to introduce an exercise~     program for BMT patients after discharge from hospital. The exercise program will include 3~     endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training~     sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic~     fitness, muscle strength, total body fat and mineral composition, and blood immune markers~     with exercise in the 100 days after BMT. The investigators anticipate this study will~     improve the QoL, mobility, and strength of patients after BMT, therefore allowing a faster~     and healthier recovery.~   "
67394|NCT02175186|"~     The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal~     Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary~     Intervention.~   "
56244|NCT02320916|"~     Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas~     exchange. However, arterial punctures are more painful than venous punctures and, in ICU~     patients, cause greater anxiety than tracheal aspiration. The only technique that has been~     shown to effectively reduce pain during arterial punctures is the subcutaneous injection of~     lidocaine. However, this technique is more time consuming and is poorly used.~      Topical anesthesia is widely used during arterial punctures despite the lack of proof of~     efficacy.~      While performing arterial punctures with small gauge needles is feasible, to the best of the~     investigators knowledge no studies have assessed the effect of needle gauge on arterial~     puncture related pain.~      The aim of the present study was to compare the pain experienced during arterial punctures~     performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of~     the pain and the anxiety associated with the arterial punctures.~   "
56245|NCT02320903|"~     The goal of the current trial is to assess the feasibility of a newly developed prototype of~     a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes~     of youth with externalizing behavioral problems by improving parental monitoring of youth~     whereabouts and activities while increasing the delivery of rewards to teens for good~     behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop~     and conduct initial feasibility testing of the VillageWhere prototype. The primary features~     of the prototype include location monitoring via smartphones' global positioning system~     (GPS) functionality as well as facilitating teen self-appraisal of meeting behavioral~     expectations. Good behavior is rewarded with points that are tracked by the app and can be~     used to redeem for real-world rewards. The investigators will conduct an 45-day open trial~     (N=20 caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved~     in the juvenile justice system or otherwise struggling with externalizing behavioral~     problems. Caregivers and teens will be assessed at baseline, before receiving the app, and~     at the end of the app use period (45 days). The therapist of each caregiver/teen dyad will~     also be assessed at the end of the app use period. Primary outcomes include: use of app~     features, monitoring of teen behavior and whereabouts, delivery of real-world rewards, and~     feasibility and acceptability. Secondary outcomes include: parenting behaviors,~     externalizing teen behaviors and internalizing teen behaviors.~   "
56246|NCT02320890|"~     The primary objective of this study is to investigate whether the transcranial direct~     current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive~     Impairment (MCI)~   "
56247|NCT02320877|"~     In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep~     apnea (OSA) (AHI > 15/h sleep) will be included and treated with mandibular advancement~     devices (MAD). These patients will undergo cardiovascular examination; echocardiography and~     24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients.~     These cardiovascular examinations will take place before and during MAD therapy.~   "
56248|NCT02320864|"~     To evaluate operational aspects of studying pre to post surgery/hospitalization changes in~     the integrity of a major white matter pathways and how these contribute to reductions in the~     ability to produce forceful muscle contractions.~   "
56249|NCT02320851|"~     The purpose of this study is to evaluate the efficacy of a manualised, multimodal group~     psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform~     vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs)~     in patients with SVD. The investigators hypothesise that patients who received IPT will~     demonstrate greater improvement concerning their vertigo-related handicap compared to~     patients from the SHGs. The investigators will also analyse the cost-effectiveness of~     experimental and control intervention.~   "
56250|NCT02320838|"~     The purpose of this study is to determine whether the transcutaneous application of~     unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal~     and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover~     evidence whether the effect and comfort of this current is greater than Conventional TENS~     (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical~     pain.~   "
56251|NCT02320825|"~     The purpose of this study is to find out whether giving one higher dose of radiation is as~     good at treating the tumor in the patient's spine after surgery as giving three lower doses~     of radiation.~   "
56252|NCT02320812|"~     This study evaluates the safety and potential activity of a single dose of live human~     retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Two~     different dose levels of cells will be assessed in each of two groups of patients.~   "
56253|NCT02320799|"~     The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of~     HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence.~     This pilot study will provide data on the efficacy trends, acceptability and feasibility of~     our IPT intervention and will generate preliminary findings for an R01-funded intervention~     to test the intervention's efficacy for remediating the effects of GBV trauma on mental~     health and HIV-related outcomes.~      Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU~     alone.~      Hypothesis 2: IPT+TAU will be acceptable and feasible.~   "
56254|NCT02320786|"~     Losing the ability to walk can lead to fewer opportunities to socialize with friends and~     family and participate in the community. When this happens, powered wheelchairs can provide~     access to homes and communities, contributing to health and well-being. Training by a~     qualified occupational therapist allows an individual to use a powered wheelchair safely and~     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time~     consuming for people with cognitive and physical challenges. In this study, we will ask~     participants with cognitive impairments to complete training with an occupational therapist~     using either a shared control wheelchair or training methods according to the standard of~     care. We believe shared control training, entitled Collaborative Powered mobility Innovative~     Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning.~     CoPILOT has the potential to enable people to participate more in their day to day lives and~     regain mobility independence.~   "
56255|NCT02320773|"~     A study to understand the impact of Betmiga® on patients quality of life, satisfaction with~     treatment, how long patients remain on treatment, patterns of healthcare resource~     utilisation, and safety as prescribed by the physicians in routine clinical practice.~   "
56256|NCT02320760|"~     This randomized controlled study evaluates the effect of individualized physical activity on~     prescription (PAP) in older overweight adults. The primary hypothesis is that an~     individualized prescription of physical activity increases physical activity level in~     overweight older adults after 6 months. Secondary hypothesis are that the increased physical~     activity level will improve cardio metabolic risk factors and quality of life.~      200 women and men, aged 65 with low physical activity level, overweight, and abdominal~     obesity, will be randomized to an intervention group or a control group. The control group~     receives general information about physical activity and registration of physical activity~     level for one week. The intervention group receives in addition an individualized physical~     activity on prescription with patient-centered counseling.~      After six months both groups go through the same health check-up as at baseline and~     follow-ups take place after 12 and 24 months.~   "
56257|NCT02320747|"~     Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential~     movements, providing a smooth, continuous and low intensity activity. It has been promoted~     to improve balance and strength and to reduce falls in the elderly, especially those 'at~     risk'. The potential benefits in healthy younger age cohorts and for wider aspects of health~     have received less attention.~      The present study documented prospective changes in balance and vascular responses for a~     community sample of adults.~   "
56258|NCT02320734|"~     Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure~     where the use of deep neuromuscular block (NMB) may increase field visibility and~     anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on~     indication only OR by continuous infusion. We hypothesize that deep NMB by continuous~     infusion of rocuronium as compared to on demand bolus administration facilitates surgical~     and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses~     of sugammadex are needed to reverse NMB at the end of surgery.~      Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on~     indication only on surgical and anesthesia conditions in patients for endoscopic esophageal~     resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed~     in both groups in an economical perspective and to compare the intra-operative cardiac and~     respiratory incidents and post-operative complication rate of both groups.~      Study design: a single-center randomized controlled double-blinded intervention study.~      Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal~     resection.I Intervention: Patients are randomized to receive either continuous infusion of~     rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group~     2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.~      Main study parameters/endpoints: The primary outcome parameter of this study is the SRS~     during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes~     measured are SRS during the thoracic phase, the number of on demand boluses infused, the~     dose of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a~     cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the~     ability of surgeons to estimate which neuromuscular blocking regime was given to the~     patient.~   "
56259|NCT02320721|"~     Primary Objective:~      To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated~     hemoglobin A1c (HbA1c)~      Secondary Objectives:~      To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:~        -  Percentage of patients with at least one severe and/or confirmed (by plasma glucose~          ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning~        -  Percentage of patients with at least one nocturnal (from 00:00-05:59) severe and/or~          confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event~        -  Percentage of patients with at least one severe and/or confirmed (by plasma glucose~          ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day~        -  HbA1c change~   "
56260|NCT02320708|"~     This is a dental pain study evaluating the efficacy and safety of a single dose of test~     acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen~     (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of~     three or four third molars.~   "
56261|NCT02320695|"~     The purpose of this study is to have subjects report whether or not several antibiotic~     products sting when they are applied to minor wounds created on the inner arms.~   "
56262|NCT02320682|"~     What is the intensity of F-PET uptake adjacent to four analyzed hip endoprosthetic~     components and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?~   "
56263|NCT02320669|"~     This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine~     (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease~     during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.~   "
56264|NCT02320656|"~     HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define~     predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and~     myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in~     vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.~      HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic,~     pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes~     and myeloproliferative disorders by collecting, at diagnosis and/or complete remission~     and/or relapse:~        -  tumor samples: marrow aspiration, blood sampling.~        -  non-tumor samples: skin biopsy, buccal swab . from 300 patients treated at our cancer~          center.~   "
56265|NCT02320643|"~     The purpose of this study is to evaluate the efficacy, recurrence, postoperative~     complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ~     prolapse.~   "
56266|NCT02320630|"~     This trial aims to compare the cost effective and effect of preventing recurrence by~     different treatment of TFP and HCQ combined SSZ for remittent RA.~   "
56267|NCT02320617|"~     The purpose of this study is to investigate the diagnostic accuracy of ADC value of~     diffusion weighted MRI in comparison of conventional treatment assessment criteria in~     evaluation of chemotherapy. Moreover, the investigators aim to clarify the correlation of~     ADC value with histologic type and grade of lung cancer and survival of patients.~   "
56268|NCT02320604|"~     Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are~     not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific~     patient population is still largely unknown.~      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic~     gastric bypass surgery will receive a single dose of 2 mg/kg or 3 mg/kg AmBisome (besides~     standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then~     be compared to the pharmacokinetics of a normal-weight group.~   "
56269|NCT02320591|"~     This study assesses the effects of the Centers for Medicare and Medicaid Services'~     Comprehensive Primary Care (CPC) initiative on physician practices, practice staff, Medicare~     and Medicaid costs and service utilization, quality of care, and patient outcomes. CPC~     provides financial resources, timely feedback on key practice outcomes, and a learning~     network to support practice transformation to improve quality of care and lower costs.~   "
56270|NCT02320578|"~     The aim of this prospective randomized pilot study is to verify if the operative time of a~     Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical~     cancer (FIGO stages IA2-IB1-IIA<2cm) and for advanced stage cervical cancer (FIGO stages~     IB2-IIA>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical~     response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus~     standard laparoscopy~   "
56271|NCT02320565|"~     This prospective randomized pilot study is aimed to verify if the operative time of a total~     laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO~     stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy~   "
56272|NCT02320552|"~     The purpose of this study is to determine the prevalence of protein-energy wasting and~     obesity among Danish dialysis patients.~   "
56273|NCT02320539|"~     The purpose of this study is to validate results from a related trial (NCT01791257) and to~     compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage~     with and without systemic complications.~   "
56274|NCT02320526|"~     Interval training is superior to continuous training for improving glycemic control,~     hereunder glycemic variability and -spikes. However, the underlying mechanisms and the~     clinical impact is at present unknown.~      The overall objective of this project is to determine the mechanisms underlying aeroic~     interval-training-induced reductions in glycemic variability and -spikes, and the impact on~     levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic~     interval training reduces glycemic variability and -spikes more than continuous training due~     to larger improvements in both peripheral insulin sensitivity and the mass action effect of~     glucose. Moreover, it is hypothesized that these reductions in glycemic variability and~     -spikes also reduces systemic inflammation.~   "
56275|NCT02320513|"~     This is a pilot study intended to gather data in order to inform future studies about the~     role of feedback as an incentive for increasing levels of physical activity which could~     improve health in hemodialysis patients.~   "
56276|NCT02320500|"~     Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as~     potential candidates for a knee replacement will receive standard physiotherapy or~     myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation,~     the investigators expect those who receive myofascial-specific therapy to experience reduced~     pain (compared to the standard therapy group) and increased flexibility compared to baseline~     levels. This simple conservative therapy could postpone (or in some cases, eliminate) the~     need for a knee replacement since pain is the major indication for surgery. If successful,~     this treatment could improve the quality of life and increase productivity for thousands~     suffering from knee osteoarthritis and preserve valuable health care resources.~   "
56277|NCT02320487|"~     This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of an~     obinutuzumab + bendamustine (BG) induction therapy in patients with previously untreated~     chronic lymphocytic leukemia (CLL). The anticipated time on study treatment is 24 weeks. The~     target sample size is 100.~   "
56278|NCT02320474|"~     This is a one-year pilot, interventional, prospective, single arm, non-randomized,~     multicentric (3 centers) controlled study that aims to evaluate the response of type 3~     choroidal neovascularization to treatment by Aflibercept following a classic protocol.~   "
56279|NCT02320461|"~     The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with~     relevant information regarding the development and progression of clinical and subclinical~     chronic diseases, particularly cardiovascular diseases and diabetes. The investigators~     enrolled 15,105 civil servants from predefined universities or research institutes. Baseline~     assessment (2008-2010) included detailed interviews and measurements to assess social and~     biological determinants of health, as well as various clinical and subclinical conditions~     related to diabetes, cardiovascular diseases and mental health. For the ascertainment of~     incident events, annual telephone surveillance is being conducted since 2009, and a second~     visit of interviews and exams is under way (2012-2014). Long-term biological sample storage~     is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and~     collaboration via specific research proposals directed to study investigators is welcome.~      This multicenter study is chaired by a steering committee, made up of the coordinators and~     vice-coordinators of each of the six centers. No individual center coordinates the study.~     The six institutions listed in the contact details all sponsor the study.~   "
56280|NCT02320448|"~     This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal~     Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal~     cancer.~   "
56281|NCT02320435|"~     This is a single-arm, multi-center, open-label extension study designed to provide~     pertuzumab to patients who continue to derive benefit from pertuzumab, as well as to collect~     long-term safety and efficacy data of pertuzumab therapy. Patients receiving pertuzumab as~     an investigational medicinal product (IMP) in a Roche-sponsored Global study who continue to~     receive pertuzumab at the time of the Parent study end are eligible for continued treatment~     in this extension study. Patients with solid tumors who have not experienced progressive~     disease in the Parent study and, in the Investigator's opinion, may potentially benefit from~     continued Perjeta treatment will continue to receive pertuzumab until disease progression,~     unacceptable toxicities, Investigator decision, patient non-compliance, patient death,~     patient request to withdraw, or study termination by the Sponsor.~   "
56282|NCT02320422|"~     The purpose of this study is to pilot-test a tailored telemetric intervention to improve~     adherence to medications in adults who had a liver transplant and are presently non-adherent~     (as measured by tacrolimus levels).~   "
56283|NCT02320409|"~     The purpose of this study is to evaluate to determine the effect of food on the PK of a~     single dose of 250 mg Sufatinib and its metabolites in healthy subjects.~   "
56284|NCT02320396|"~     This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants~     with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the~     change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine~     compared to placebo.~   "
56285|NCT02320383|"~     A Prospective, Multicenter, Randomized Phase-Ii Trial Comparing Efficacy And Safety Of~     Fludarabine + Cyclophosphamide + Ga101 (Fcg) And Bendamustine + Ga101 (Bg) In Patients With~     Relapsed Or Refractory Cll Followed By Maintenance Therapy With Ga101 For Responding~     Patients~   "
56287|NCT02320357|"~     CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus~     (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement.~     As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of~     clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.~   "
56288|NCT02320344|"~     The 3-month face-to-face Partners in Care intervention will be community-based and~     community-led by trained community peer educators from these four partnering community~     organizations. The intervention involves 12 weekly, group lessons with each lesson lasting~     about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels)~     greater than or equal to 7% will be recruited for the study because they represent the most~     at-risk for diabetes-related complications. Over a 3-year accrual period, the community~     partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate~     the intervention in their respective community settings. The primary outcomes of our study~     are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes~     are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood~     pressure, body mass index, and psychosocial adaptation.~   "
56289|NCT02320331|"~     The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness~     of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating~     obesity in Pacific Peoples across the four islands. Dissemination will involve~     implementation of the program in eight communities through partnerships with nine different~     community-based organizations serving those areas (four founding community partners and five~     new community partners). These organizations provide services to a large number of Pacific~     Peoples, including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.~      The main aims are to: (1) train five additional community organizations and their staff to~     deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese~     participants across 8 different communities and four different islands into the intervention~     program, and (3) to evaluate the effectiveness of the program in reducing weight/BMI by at~     least 3% of the participant's initial weight.~      The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual~     health behaviors in the context of family and community environments and in the~     socio-cultural context of Pacific Peoples. In order to increase the likelihood that an~     organization will implement the PLP, they will be able to adapt the intervention and~     participant assessments. The POP will provide guidance on adaption of the intervention and~     assessments at the training (CHS #21680). What is described below is the maximum amount of~     contact and assessment procedures that participants will undergo. Therefore, organizations~     may change the timing of the 14 lessons and refrain from using all the assessment~     procedures, but will still provide the 14 lessons and offer the same incentives to~     participants for assessments.~   "
56290|NCT02320318|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of~     this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily~     as compared to placebo in women with IBS-D over a 12-week treatment period.~   "
56291|NCT02320305|"~     This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1~     (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid~     A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that~     has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body~     build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with~     MART-1 antigen may help increase the immune response to MART-1a antigen.~   "
56292|NCT02320292|"~     This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to~     see how well they work compared to rituximab alone in treating patients with untreated~     follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and~     help kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer~     cells and give off radiation which may help kill cancer cells. It is not yet known whether~     rituximab works better with or without yttrium Y-90 ibritumomab tiuxetan in treating~     follicular lymphoma.~   "
56293|NCT02320279|"~     The objective is to contribute data to ongoing research activities focused on identification~     of EKG waveform changes in the context of clinical conditions and maternal medication use.~     Additionally, to develop the capacity to measure contractions more accurately and more~     reliably using skin-surface electrodes.~   "
56294|NCT02320266|"~     Deep brain stimulation (DBS) is an FDA approved, and widely used method for treating the~     motor symptoms of Parkinson's disease (PD), Essential Tremor (ET), Dystonia and Obsessive~     Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS~     devices. Current approved methods to locate the DBS target regions in the brain use a~     combination of stereotactic imaging techniques and measurements of the electrical activity~     of brain cells. As part of the standard clinical technique, electrical data are collected~     from individual nerve cells. The target brain region emits unique electrical signals. At~     certain brain locations, during DBS surgery, additional electrical data that are generated~     in response to sound will be collected. Regions of the brain that have a decreased response~     to repeated sound (auditory gating) may be important DBS targets for improving thinking. The~     aims are (i) during DBS surgery, in addition to EEG, use microelectrodes in the brain to~     find brain regions, along the normal path to the DBS target, where auditory gating occurs~     and then (ii) determine if stimulation of the identified region(s) alters auditory gating~     measured by EEG. Also an additional aim (iii) is to measure electrical activity at the scalp~     with EEG to characterize auditory gating in patients before and after DBS surgery and also a~     healthy control population.~   "
56295|NCT02320253|"~     The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for~     type 2 diabetes and obesity into usual care at community health centers, comparing an~     in-person group program (IP), a telephone conference call (TCC) group program, and referral~     to medical nutrition therapy (MNT), the current standard of care.~   "
56296|NCT02320240|"~     The purpose of this study is to determine if there is an excess risk of acute kidney injury~     (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective~     serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of~     depression.~   "
56301|NCT02320175|"~     The investigators propose implementing a bundle of communication interventions - Patient and~     Family-Centered I-PASS - to improve the quality of information exchange between physicians,~     nurses, and families, and to better integrate families into all aspects of daily decision~     making in hospitals. The investigators believe that doing so has the potential to~     substantially improve both patient safety and patient and family experience.~      The specific aims of the project are - To test the hypothesis that a) rates of serious~     medical errors (including both preventable adverse events and near misses), determined both~     by an established, systematic daily hospital surveillance methodology (primary outcome) and~     family reports (secondary outcome); as well as b) poor verbal handoffs during family~     centered rounds (FCRs - assessed through direct observation - secondary outcome); rates of~     discordant understanding of the care plan between healthcare providers and families~     (assessed through survey instruments - secondary outcome); and rates of family (primary~     outcome) and nurse and physician dissatisfaction (secondary outcomes) will decrease~     following implementation of Family-Centered I-PASS, as compared with current practice.~   "
56302|NCT02320162|"~     The aim of this project was to compare the effectiveness of experiential learning (EL) and~     traditional lecturing (TL) school-based oral health education on the oral health knowledge,~     attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old~     Greek children. Thee hundred and fifty children were selected from three areas of Greece.~     Information on oral health knowledge, attitude and behaviour were obtained using a~     questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was~     assessed using the simplified gingival index and dental caries was measured by recording the~     number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the~     Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated~     dentists, using a World Health Organisation (WHO) periodontal probe and artificial light.~     Questionnaires were delivered and clinical examinations were performed at baseline and at 6~     and 18 months post-intervention. The EL oral health educational program was implemented by~     teachers using the program's manual.~   "
56303|NCT02320149|"~     To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline~     compared to placebo in the treatment of moderate to severe facial acne vulgaris~   "
56304|NCT02320136|"~     The investigators want to characterize high-frequency oscillations (HFOs) in intracranial~     recordings, which may occur as markers of epileptogenic tissue and also under physiological~     stimulation.~      The investigators want to show that recording of high-frequency oscillations (HFOs) is~     feasible in our project population both intraoperatively and during presurgical~     physiological conditions.~   "
56305|NCT02320123|"~     Racial differences in health care are documented across the health care continuum and~     persist in aging and end-of-life (EOL) care. African Americans (AA) and other~     underrepresented minorities often choose more aggressive therapies at the end of life and~     are less likely to utilize hospice care in the terminal stages of their illness. Potential~     reasons for these disparities include: lack of knowledge of and misperceptions about~     palliative and hospice care, spiritual beliefs, and mistrust in the health care system,~     among others. Despite the literature on disparities in end-of-life (EOL) care and reasons~     for underuse and the presence of national EOL care guidelines, attempts to address this~     problem have been limited and often not rigorously evaluated. The majority of interventions~     to promote EOL care were done in majority populations and focused predominantly on trying to~     change physician awareness of patient's pain, symptoms, and values or to change physician~     communication behavior. While these early studies made tremendous contributions to the study~     of EOL care and the needs of the terminally ill, the interventions associated with these~     studies did not reach their desired effectiveness. The investigators propose a different~     strategy that would focus specifically on previously identified barriers to utilization of~     advance directives, palliative care, and hospice care among African Americans - including~     physicians' difficulty and discomfort with prognostication, AA patients' knowledge,~     attitudes and beliefs towards hospice and palliative care, conflict between patients'~     spiritual beliefs and the general hospice and palliative medicine philosophy of care, and~     medical mistrust. The goal of this project is to improve methods of prognostication for~     physicians and increase awareness of EOL care options for AAs. To overcome the dual~     challenges of physicians' reluctance to discuss EOL care and patients' discomfort in~     engaging in such conversations, the investigators will use the electronic medical record~     (EMR) to automatically identify AA patients with life-limiting illness who are eligible for~     counseling about EOL care options. To change knowledge and attitudes toward EOL care options~     among AA patients, the investigators will design a culturally sensitive intervention that~     will combine multimedia materials and a culturally concordant lay health advisor who will~     deliver tailored education and counseling.~   "
56306|NCT02320110|"~     Childhood obesity is one of the most serious global public health challenges of the 21st~     century (Daniels et al., 2009). Mexico has the highest prevalence of obesity, (Secretaría de~     Salud, 2009); 34.4% of children and 35% of adolescents are overweight or obese (ENSANUT~     2012). Obesity has major health consequences for children and adolescents; On the other~     hand, undernutrition as well has important deleterious consequences on children's health.~      Anything that disrupts energy balance may cause individuals to be underweight, overweight or~     obese. Fat has been considered an endocrine organ for some time (Elizondo, 2011). Recently,~     skeletal muscle has been shown to function as a peripheral endocrine organ by releasing~     myokines, (Pedersen, 2012). Most recently, a new identified hormone secreted by muscle~     tissue in mouse, irisin, has been discovered. Irisin acts on white adipose cells in culture~     and in vivo to stimulate UCP1 expression and a broad program of brown-fat-like development.~     Irisin was induced with exercise in mice and humans which caused an increase in energy~     expenditure in mice with no changes in movement or food intake (Boström et al., 2012).~      Irisin was thus, promptly hypothesized as a hormone influencing body weight, obesity and~     type 2 diabetes mellitus, among other conditions (Sanchis-Gomar et al., 2012). Some studies~     have indicated that circulating levels of irisin in humans correlate positively with~     anthropometric parameters such as BMI, fat mass, fat free mass, and are higher in obese~     patients compared to lean ones (Stengel et al., 2013; Huh et al., 2012; Roca-Rivada et al.,~     2013; Crujeiras et al., 2014; Pardo, 2014). Studies have shown an association between irisin~     levels, insulin resistance and the metabolic syndrome (Park et al., 2013; de la Iglesia et~     al., 2014; Crujeiras et al., 2014; Pardo et al., 2014). However, some others have found a~     negative correlation with anthropometric parameters, finding lower irisin levels in obese~     patients (Moreno-Navarrete et al., 2013). Noteworthy, all these studies have been performed~     in adults. To date, there are only two studies evaluating irisin levels in children. One~     found that a 1-year long lifestyle intervention program was associated with an elevation in~     irisin levels in obese children, although no correlation was found between irisin levels and~     anthropometric markers (Blüher et al., 2014). The other study investigated normal weight~     Saudi children and found correlations between circulating irisin and glucose and HDLc, but a~     negative association with insulin resistance (Al-Daghri et al, 2014).~      Besides, associations between irisin levels and adiponectin, leptin and resistin in the set~     of obesity have been explored, the three of them are implicated in the physiopatology of~     obesity.~      As there are still conflicting data regarding the association of irisin with anthropometric~     parameters, obesity and the metabolic syndrome, as well as its 'association with other~     adiponectines, and most important, there is scarce data of these associations in children,~     the objective of this study will be to correlate the circulating irisin and adipokines~     levels across a broad spectrum of body mass index ranging from undernourished to obese as~     well as with insulin resistance and risk factors for the metabolic syndrome in Hispanic~     children.~      The sample size with statistical power for this study yielded a sample of 40 children.~     Frozen stored plasma (-80°C) will be taken from a previous study performed in children which~     has been published (Elizondo-Montemayor et al., 2014). The samples will be divided into five~     groups, 8 per group, according to the CDC and American Academy of Pediatrics body mass index~     percentile classification: 1.) underweight = <3 percentile; 2.) normal weight = >3 - < 85~     percentile; 3.) Overweight = >85 - < 95 percentile, and 4.) obese = > 95 percentile. The~     fifth group will correspond to children with known metabolic syndrome according to the~     classification specified by Cooks et al (2008). Anthropometric measurements will include~     BMI, percentile BMI, waist circumference, % body fat, fat mass, fat free mass, and triceps~     skin fold. Biochemical measurements will include glucose, total cholesterol, low-density~     cholesterol (LDL), high-density cholesterol (HDL-c) and triglycerides. Clinical measurements~     will include blood pressure, physical activity records and dietary habits. All biochemical,~     anthropometric and clinical measurements were previously performed in a former published~     study (Elizondo-Montemayor et al., 2014).~      Irisin, adiponectin and leptin will be measured in plasma media using commercial ELISA kits.~   "
56307|NCT02320097|"~     When examining a subject in quiet stance from the side, the leg segment is usually seen to~     be oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the~     shoulders are behind the great trochanter and the head is held forwards. The forward head~     position moves the center of gravity forwards and thus may increase pressure under the~     forefoot. Conversely, moving the head backwards should be accompanied by an increase in~     pressure under the heel and thus decreased pressure under the forefoot.~      The study's objective is to study the influence of alignment of the head with the back (i.e.~     a rearward head position) and head rotation on the foot pressure distribution (measured~     using a foot pressure platform).~   "
56308|NCT02320084|"~     The purpose of this study is to look at the long term safety profile of Orfadin treatment in~     patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study~     will use Orfadin according to normal clinical practice.~   "
56309|NCT02320071|"~     The primary objective of the present study is to investigate a possible correlation between~     abdominal wall function and subjective measures of QoL before and after laparoscopic repair~     of small- to medium sized incisional hernia.~      This prospective study includes 25 patients undergoing laparoscopic incisional hernia~     repair. Abdominal wall function is examined by determination of maximal truncal flexion and~     extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä,~     Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical~     activity (International Physical Activity Questionnaire) are assessed. Patients are examined~     before, one month after and three months after the operation. Furthermore, pulmonary~     function is examined preoperative and three months postoperative by standard spirometry~     (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well~     as maximum in- and expiratory pressure is measured.~   "
56310|NCT02320058|"~     This is an open-label, multi-site Phase 2 study of Nivolumab combined with Ipilimumab~     followed by Nivolumab monotherapy for the treatment of subjects with Melanoma metastatic to~     the brain. Patients with histologically confirmed Malignant melanoma and asymptomatic brain~     metastases are eligible for the study.~   "
56311|NCT02320045|"~     A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and~     moderate renal impairment compared to the pharmacokinetics of subjects with normal renal~     function~   "
56313|NCT02320019|"~     Research Hypothesis:~      There will be a greater proportion of VAS responders defined as those who achieve ≥ 50%~     reduction from baseline in VAS for low back pain at week 12 following intradiscal injection~     of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic~     lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have~     suffered from persistent low back pain with at least 3 months of conservative therapy and~     must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI)~     ≥30% at the baseline.~   "
56314|NCT02320006|"~     Acupuncture is one of the traditional Chinese practices widely used in China for more than~     3000 years. In recent years, the use of acupuncture within infertility has gained popularity~     all over the world, but there is no research describing the use of acupuncture in~     infertility of incompletely obstructive fallopian tube. In this paper, we present a research~     design evaluating the effects of acupuncture on incomplete fallopian tube obstructive~     infertility. This is a randomized, control acupuncture and signal-blind trial. A total of~     120 patients will be enrolled in this study and will be randomized into two groups. True~     acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed~     for 12 weeks. The purpose of this paper is to evaluate the additional value of acupuncture~     on the tubal patency rate and pregnancy rate beyond Hydrotubation ,therefore to guide~     clinical.~   "
56315|NCT02319993|"~     keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life,~     Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan~   "
56316|NCT02319980|"~     The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass~     surgery could prevent rebleeding and improve neurological function in adult moyamoya with~     hemorrhagic onset.~   "
56317|NCT02319967|"~     Chicago is an epicenter for asthma health disparities in the U.S., with African-American~     children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of~     these disparities is the high rate of visits to the Emergency Department (ED) for~     uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of~     guideline recommendations for ED discharge and strategies to reduce environmental triggers~     at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Trial~     tests both ED- and home-level interventions to improve clinically meaningful outcomes in a~     minority pediatric ED population with uncontrolled asthma.~   "
56318|NCT02319954|"~     Periorbital edema and ecchymosis are common morbidities in the post-operative period after~     rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large~     contributing factors to the degree of bruising and edema. This is due to injury to the~     angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling~     and bruising, it can cause difficulty with visual acuity in the early post-operative period.~     Most importantly, this can be quite distressing to the patient and impact the time required~     to return to normal social activities. Numerous studies have examined various interventions~     to reduce periorbital swelling and ecchymosis. These include peri-operative steroids,~     lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative~     hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most~     extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids~     were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry~     with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose~     and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques~     to minimize post-operative edema and ecchymosis without the risk profile of steroids would~     be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative~     cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study~     group received compression with a cold saline soaked gauze to the nasal dorsum during the~     surgery and the control group received compression with a dry gauze. Both groups received a~     pre-operative dose of intravenous steroids. The study group had significantly less~     periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study~     unfortunately did not examine the role of compression alone and the study was performed in~     the presence of steroids, which is not routinely utilized by all surgeons. As such, the~     proposed study will provide evidence for the use of direct compression intra-operatively~     after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings~     of this study may provide a simple, effective and non-costly technique to minimize the~     morbidity of rhinoplasty.~   "
56319|NCT02319941|"~     The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel~     for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes~   "
56320|NCT02319928|"~     This protocol describes the epos (ancient greek (Επος) for story) of a group of related~     clinical trials aiming at addressing one of the most important unsolved challenges in the~     prevention of colorectal cancer (one of our major cancer killers); the surveillance of~     patients with premalignant polyps in the large bowel.~      This project is timely because large scale colorectal cancer screening programmes are~     currently rolled out in most Western countries. These programmes are diagnosing large~     numbers of individuals with premalignant polyps (adenomas and serrated polyps). This creates~     both a diagnostic and resource dilemma, because the optimal surveillance strategy for these~     individuals to reduce future cancer risk is currently unknown..~      The EPoS trials will randomize or register more than 27,500 individuals in different~     European countries to different surveillance colonoscopy intervals to disentangle the most~     effective and cost-effective surveillance strategy for the population. Subjects will be~     randomized according to their presenting polyp chracteristics The EPoS I trial randomizes~     patients with low-risk adenomas into 5 or 10-year surveillance; ; EPoS II randomizes~     patients with high-risk adenomas into 3 or 5-yearly surveillance ; EPoS III will include~     patients with serrated polyps in a one-arm study with surveillance after 5 and 10 years. The~     primary endpoint for all three trials is incidence of colorectal cancer after 10 years of~     follow-up.~      This EPoS trials are the largest in polyp surveillance ever conducted. They address a~     clinical problem affecting hundreds of thousand individuals in Europe and the US each year,~     it has a large size, and should thus provide definitive results.~   "
56321|NCT02319915|"~     Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or~     without adrenaline, in a population of patients undergoing knee replacement.~   "
56322|NCT02319902|"~     To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea~     and analgesic requirements in post operative patients compared to standard cold carbon~     dioxide.~   "
56338|NCT02319694|"~     This project studies the impulsive side effects of common treatments for Parkinson's~     Disease. By learning how parts of the brain involved in Parkinson's encode information~     related to reward and motivation, the investigators will better understand the reasons why~     Parkinson's patients often suffer from compulsive gambling, hypersexuality, and repetitive~     tinkering (punding). These results may lead to the design of better methods of deep brain~     stimulation (DBS) that minimize the behavioral side effects of Parkinson's treatment.~   "
58103|NCT02296619|"~     The purpose of this study is to determine the effects of Transversus Abdominis Plane Block~     on hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in~     patients undergoing total abdominal hysterectomy~   "
56323|NCT02319889|"~     This pilot clinical trial studies stereotactic body radiation therapy followed by~     combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic~     body radiation therapy is a specialized radiation therapy that delivers one to five high~     doses of radiation directly to the tumor and may kill more tumor cells and cause less damage~     to normal tissue than conventional radiation. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving stereotactic body radiation therapy,~     followed by carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill~     more tumor cells and result in a better and more durable response than conventional~     radiation and chemotherapy. The purpose of this study is to test the safety of this approach~     prior to larger studies.~   "
56324|NCT02319876|"~     The current project was designed to examine the express TIM-3 on lymphocytes and monocytes~     and its role in immunosuppression during sepsis.~   "
56325|NCT02319863|"~     This study examines the role of this simple technique on postoperative metastasis and long~     term survival.~   "
56326|NCT02319850|"~     Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals~     over the age of 60 and results in a 3 to 4 times increased likelihood of developing a~     disability. Despite these observations, sarcopenia is rarely subject to a systematic~     screening process as a part of customary geriatric care. Furthermore, when lean body mass~     (LBM) is measured via dual energy X-ray absorptiometry (DXA) in older adults, it is~     typically within a reactive, hospital-based, model of healthcare where muscle wasting is~     only assessed after a loss of functional independence. The investigators propose an~     affordable, portable screening method with ultrasound imaging to be performed in primary~     care settings.~      The investigators long term goal is to identify individuals at risk, and intervene with~     treatments that may prevent the onset of debilitating loss of muscle function in the~     elderly.~   "
56327|NCT02319837|"~     The purpose of this study is to assess enzalutamide plus leuprolide in patients with~     high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or~     radiotherapy or both.~   "
56328|NCT02319824|"~     This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T~     cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that~     have spread to other places in the body and are receiving palliative (relief of symptoms and~     suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into~     white blood cells may help the body build an immune response to kill tumor cells that~     express NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live~     more comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy~     may be a better treatment for patients with sarcomas.~   "
56329|NCT02319811|"~     The purpose of this study is to determine the long-term survivorship and clinical outcomes~     of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.~   "
56330|NCT02319798|"~     Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and~     ulcerative colitis) that affect the intestines. The number of new cases of IBD in people~     younger than 16 years old has been increasing in the United Kingdom (UK), and is currently~     estimated to be 700 new cases every year. There is no cure for IBD and patients experience~     episodes of flareups in between periods of wellbeing.~      Traditionally, children with IBD are asked to attend regular hospital appointments. This~     means that, even if they are well, they have to get to the hospital and this can involve~     travelling long distances.~      Telephone consultations have been shown to be beneficial in some areas of medicine but this~     approach has not been well studied in children. The aims of this study are to determine~     whether telephone consultations would improve quality of life, patient satisfaction,~     proportion of consultations attended and whether they would be safe and reduce costs for~     patients and the National Health Service (NHS). Investigators plan a randomised controlled~     trial involving 92 participants recruited from amongst the 250 children and adolescents aged~     between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half~     will be assigned to telephone consultations, and half to face to face consultations. The~     study would have the approval of the local ethics committee and participants would have~     provided written consent. Investigators will compare outcomes in the two groups over 2~     years. If telephone consultations prove to be effective, the NHS could offer children with~     IBD the choice of either telephone consultation or face to face consultation for their~     outpatient followup. Those who are doing well would not have to make unnecessary journeys to~     the hospital. This would free up clinic spaces and allow patients who are unwell, and new~     patients to be seen more quickly, thus reducing waiting~   "
56331|NCT02319785|"~     The main purpose of this study is to examine the treatment effects and the combined-therapy~     of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different~     sensory feedback and one group of unilateral RAT in the investigators trial to compare the~     relative treatment effects to mirror therapy group, bilateral RAT, and conventional~     rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of~     life, and kinematic variables.~   "
56332|NCT02319772|"~     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and~     pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM)~     injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in~     part 2 subjects will receive BCX4430 for 7 days.~   "
56333|NCT02319759|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab~     in participants with Active Psoriatic Arthritis (PsA).~   "
56334|NCT02319746|"~     General objective:~      To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive~     behavioral treatment + pharmacological treatment) compared to standard treatment~     (pharmacological treatment + psychoeducation) in patients with first episodes psychosis~     (FEP) cannabis users.~      Design A multicenter single-blind randomized study with 1 year of follow-up. The~     effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral~     treatment + pharmacological treatment) compared to standard treatment (pharmacological~     treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users~     will be assessed.~      Patients will be randomly assigned to one of two treatments:~        1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse +~          pharmacological treatment~        2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment~   "
56335|NCT02319733|"~     The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS)~     for intermediate coronary lesions with morphological signs of vulnerable plaque in patients~     prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural~     vasomotion and increase vascular diameter.~   "
58104|NCT02296606|"~     Prospective, observational, non-randomized study of interrater reliability of pupillary~     assessments, comparing two clinical assessments to the Pupillometer.~   "
56339|NCT02319681|"~     This study seeks to establish the acceptability and evaluate the limited efficacy of Simple~     Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve~     stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in~     community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged~     episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger,~     and sometimes even violence.~      SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's~     memory to interrupt a current episode of anxiety.~   "
56340|NCT02319668|"~     The primary objective of this study will be to evaluate the effect of two week pre-surgical~     rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on~     the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will~     be conducted at Eastman Clinical Investigation Centre (ECIC), University College London~     (UCL) Eastman Dental Institute. Participants will be those who require a single and simple~     surgical implant to be placed, and will be recruited from new patient referrals within the~     Eastman Dental Hospital~   "
56341|NCT02319655|"~     During the last decade optical coherence tomography (OCT) extended the possibilities for in~     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of~     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased~     scanning speed and image-resolution provides more detailed information of microstructures in~     the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the~     eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as~     uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer~     from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed~     to remove the ERM.~      Different study groups showed that intraoperative use of SD-OCT is possible. Two groups~     already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial~     resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the~     subfoveal region appearing directly after the membrane peeling procedure. It was~     hypothesized that this phenomenon could be an expression of surgical trauma, as this~     hyporeflective zone disappears in follow up OCT 10 days after surgery.~   "
56342|NCT02319642|"~     This study will continue to evaluate the safety & efficacy of Certolizumab Pegol (CZP) for 6~     months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.~   "
56343|NCT02319629|"~     Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the~     gallbladder function which is secondary to surgery. Many observational studies support this~     fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in~     them. According to another publication, the incidence of gallbladder diseases is 5-36% after~     jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.~   "
56344|NCT02319616|"~     The primary objectives of this study are to investigate the efficacy and safety of topical~     steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of~     toxic epidermal necrolysis (TEN).~   "
56345|NCT02319603|"~     A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing~     clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial~     premature beats by different dose,to provide a scientific basis for rational clinical use of~     drug.~   "
56346|NCT02319590|"~     The study aims 1) to determine autoantibody titers against the AGTR1 receptor and against~     the ETA receptor, 2) to characterize cytokine expression profiles of heart-specific~     activated T cells in patients with systolic heart failure. Auto-antibody titers and specific~     cytokine expression profiles in heart-specific activated T cells will then be correlated~     with heart failure progression and outcome.~   "
56347|NCT02319577|"~     A sub-population of patients affected by non-small cell lung cancer (NSCLC) with activating~     mutations of the epidermal growth factor receptor (EGFR) do not gain benefit from treatment~     with tyrosine-kinase inhibitors (TKIs). The hypothesis of this study is that the addition of~     chemotherapy with oral vinorelbine to first-line TKI might result in improved outcomes in~     EGFR-mutated patients.~   "
56348|NCT02319564|"~     The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose~     is to determine the feasibility of a randomized trial designed to determine if either~     inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil~     Compositum) are superior to placebo in treating pre-school aged children with an acute~     wheezing episode.~   "
56349|NCT02319538|"~     The investigators have already proven that absolute total thyroidectomy gives elimination of~     anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical~     Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature~     and joints and dryness in eyes and mouth. The prerequisite for this effect is the absolute~     total thyroidectomy. There exists no other treatment that can eliminate the antibodies. The~     study is randomized between operation and ordinary conservative medical treatment with~     thyroxine control and supplementation. The symptoms in both groups are evaluated by 5~     different Quality of Life schemes, internationally approved.~   "
56350|NCT02319525|"~     The study will compare the efficacy of the usual education materials to individualized~     computerized decision guide on decision conflict of patients with lupus nephritis making~     treatment decisions regarding immunosuppressive therapies.~   "
56351|NCT02319512|"~     The purpose of this study is to determine whether the use of chewing gum effects~     postoperative ileus after pancreaticoduodenectomy.~   "
56375|NCT02319200|"~     Metformin treatment during 36 months could be associated with decreased risk of HCC~     occurrence and liver related death in patients with compensated HCV cirrhosis and~     insulinoresistance.~      This study is an ancillary of the observational study from the CIRVIR cohort in which more~     than 1200 patients with compensated HCV cirrhosis are currently included.~      participating centers : 26~   "
56376|NCT02319187|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~      The purpose of this study is to evaluate the progression free survival and safety of~     irinotecan plus S1 versus S1 alone in the patients with previously treated advanced~     esophageal cancer~   "
56394|NCT02318953|"~     This study evaluate if in an ambulatory breast reconstruction patient population at Women's~     College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app~     home monitoring compared to conventional, in-person follow-up care in the first 30-days~     following surgery.~   "
56352|NCT02319499|"~     Many Indonesian infants are already iron deficient before they reach the age of six months,~     which also determines the high prevalence of anemia among under-five children. Iron~     deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency~     anemia during early childhood has a marked negative effect on child development and~     cognitive function (Lozoff et al.1991; Idjradinata & Pollitt, 1993). This negative impact on~     childhood development is one of the main reasons why iron deficiency during infancy should~     be prevented or treated.~      Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative~     consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition~     is exacerbated by the rich phytate content in the complementary foods which inhibits the~     absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc,~     hence, is expected to decrease both iron and zinc deficiencies and hence improve growth and~     development of the children.~      Recently, there has been an emerging view which looks at the two-way relationship between~     nutrition, health, and psychosocial well-being. This concept is supported by studies on~     positive deviance, a term used to refer to children who grow and develop well in~     impoverished environments where most children are victims of malnutrition and chronic~     illness (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial~     factors, such as the affect between mother and child, are associated with adequate growth~     and development: 'Psychological stress has a negative effect on the use of nutrients whereas~     psychological well-being stimulates the secretion of growth-promoting hormones. Pleasantly~     stimulating interactions can enhance the child's tendency to exercise its developing organ~     systems and hence to utilize nutrients for growth and development'.~      Understanding how the psychosocial environment can promote or inhibit the benefit of~     supplementation intervention is necessary in order to have a better way of setting about~     providing supplements. In fact, many supplementation programs do not incorporate~     complementary program elements that would help to improve the health and psychosocial~     development of children at the same time that they improve nutritional status' (Myers,~     1995). Looking from this perspective, not only will supplementation benefit the psychosocial~     development but also the psychosocial environment can promote the benefit of the~     supplementation on the nutritional status and developmental outcomes of infants.~      The purpose of the study is to investigate whether multi-micronutrient supplementations~     (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental~     outcomes, and whether the effect is modified by psychosocial care.~   "
56353|NCT02319486|"~     This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular~     retinoblastoma~   "
56354|NCT02319473|"~     Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to~     the emergency department of a national cardiac referral hospital.~   "
56355|NCT02319460|"~     This observational cohort study is designed to obtain product safety information from the~     routine clinical setting within large, diverse, community-based populations. In the setting~     of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the~     risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients~     treated with plasma will be assessed.~   "
56356|NCT02319447|"~     For most patients with kidney failure, living donor kidney transplant (LDKT) is their best~     treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney~     failure but less likely to receive LDKTs. In this study, the investigators will test an~     intervention designed to address this disparity, by performing a parallel group, two-arm~     randomized clinical trial among 500 Black kidney transplant candidates. The main objective~     of this study is to test an educational and behavioral intervention that is designed to~     increase receipt of LDKT among transplant candidates (persons active on the deceased donor~     kidney transplant waiting list) who are Black. Our overall hypothesis is that a~     multi-component intervention administered to Black transplant candidates will increase both~     readiness to pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign~     kidney transplant candidates on the kidney transplant waiting list to either: (1) a control~     group that will receive Usual Care, or (2) an Intervention group that will receive a~     group-based intervention, as well as monthly mailings and a follow-up phone call by a~     transplant educator.~   "
56357|NCT02319434|"~     The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert~     Sensor. The investigators would like to see if is generally helpful to ostomy patients and~     whether it has a beneficial impact on living with an ostomy bag. Results from this study~     will be used to determine if a larger clinical study is feasible.~   "
56358|NCT02319421|"~     Context: Alarm fatigue is a threat to hospital patient safety. National surveys reveal that~     high alarm rates interrupt patient care, reduce trust in alarms, and lead clinicians to~     disable alarms entirely. Safety huddles offer an appropriate forum for reviewing alarm data~     and identifying patients whose high alarm rates may necessitate safe tailoring of alarm~     limits.~      Objectives: To evaluate the impact of a focused physiologic monitor alarm reduction~     intervention integrated into safety huddles that involves discussing safe monitor parameter~     adjustments on the physiologic monitor alarm rates of individual patients with high alarm~     rates who meet low acuity criteria.~      Study Design: A prospective, quasi-experimental pilot study of the impact of the huddle~     intervention on the alarm rates of low acuity high alarm rate individual patients discussed~     in huddles in the PICU. The huddle intervention will consist of a script to facilitate the~     discussion of the alarm data.~      Setting/Participants: Participants will include all low acuity patients and their providers~     in the PICU at The Children's Hospital of Philadelphia.~      Study Interventions and Measures: The primary outcome is the rate of crisis and warning~     alarms per patient day for intervention cases as compared with others in the high alarm /~     low acuity cohort. Safety measures will include unexpected changes in patient acuity or code~     blue events within one week of monitor change or discharge.~   "
56359|NCT02319408|"~     Insufficient migration and activation of tumour specific effector T cells seems to be the~     one important reason for inadequate host anti-tumour immune response. Ionizing radiation can~     induce a variety of immune responses. The goal of this randomized trial is to assess if a~     preoperative single fraction low dose radiation is able to improve anti-tumour immune~     response in operable early stage lung cancer.~   "
56360|NCT02319395|"~     The  Behavioural Addiction and Genetics in Parkinson's Disease  study (BADGE-PD) is a~     national (France), multicenter, genetic association, case-control study to identify genetic~     factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to~     dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes~     supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD~     (n=200) and 200 matched PD patients without ICD (n=200).~   "
56392|NCT02318979|"~     The proposed study aims to characterize the effects of running-specific leg prosthetic~     stiffness and height during on performance during running and sprinting to optimize~     running-specific prosthesis prescription. The investigators will collect biomechanical and~     metabolic data from participants with unilateral and bilateral below the knee amputations~     while they run at different speeds on a treadmill. This data will be used to understand the~     effects of running prostheses. Then, these parameters will be used to develop prosthetic~     prescription techniques for people with below the knee amputations.~   "
56393|NCT02318966|"~     To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management~     of hepatic glycogen storage diseases (GSD).~   "
56361|NCT02319382|"~     There is accumulating evidence suggesting that inflammatory processes, through microglial~     activation, would play a key role in the neurodegenerative process of Parkinson's disease~     (PD). It is considered that microglial activation would be part of self-propelling cycle of~     neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however~     hard to evidence microglial activation in vivo, especially in the substantia nigra: first,~     the investigators need very high resolution imaging tools and then, the only ligand~     available to date, 11C-PK11195, has a low sensitivity and specificity and provided~     heterogeneous results.~      18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to~     explore the topography and intensity of microglial activation in several different groups of~     PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients~     (honeymoon) (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off~     or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to~     healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a~     new generation tomography having a very high resolution.~      This study might reveal significant neuroinflammatory process in the midbrain of PD patients~     and will determine if such process is present in both sporadic and genetic forms of PD. The~     results of this study might provide a new biomarker of disease pathological progression and~     help as identifying subjects who might most benefit from a specific anti-inflammatory drug.~   "
56362|NCT02319369|"~     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability~     and identify a Maximum Tolerated Dose (MTD)/tentative Recommended Phase II Dose (RP2D) in~     subjects with refractory or relapsed Acute Myelogenous Leukemia (AML), Acute Lymphocytic~     Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in blast phase, or high risk MDS in Part~     1-Dose Escalation and refractory or relapsed AML or high risk Myelodysplastic Syndrome (MDS)~     in Part 2-Dose Expansion.~   "
56363|NCT02319356|"~     The purpose of this study is to determine whether dietary nitrate supplementation improves~     performance in cardiopulmonary exercise testing (CPET).~   "
56364|NCT02319343|"~     This study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total knee-arthroplasty (TKA). The investigators examine the effect on~     thigh muscle function to evaluate the efficacy of Methylprednisolone on knee-extension~     strength at discharge after TKA.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will experience~     smaller loss of knee-extension strength compared to the placebo-group, early after TKA.~   "
56365|NCT02319330|"~     The overall objective of this project is to demonstrate that a low cost, cell~     phone-delivered intervention is a promising, feasible and acceptable way to improve the~     prevention and treatment outcomes of women in India who are affected by HIV and~     inter-related mental health and psychosocial risk factors.~   "
56366|NCT02319317|"~     The specific aim of this study is to assess the feasibility of a web-based intervention to~     prevent risky driving with teen drivers licensed in the previous 90 days.~   "
56367|NCT02319304|"~     The purpose of this study is to assess the effects, both good and bad, of adding very low~     dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to~     surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over~     approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX~     (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on~     the first two days of each cycle.~   "
56368|NCT02319291|"~     This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150~     RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and~     the follow up period will be 5 years. Data collection will include Radiographic Analysis,~     Knee Society Evaluation and Adverse Events.~   "
56369|NCT02319278|"~     To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of~     iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the~     myocardium of patients with:~      i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis~   "
56370|NCT02319265|"~     DAMSEL 2 is a pilot Phase II study in patients with sepsis. Stage 1 will assess the~     pharmacokinetics of melatonin and its major metabolite after a single dose of 50 or 100mg~     exogenous melatonin in two small groups of patients with sepsis in order to make dosing and~     dosing interval decisions for Stage 2.~      Stage 2 is a double blind randomised controlled trial of melatonin in patients with sepsis~     at the dose and dosing interval decided after Stage 1. Measurements of melatonin and its~     major metabolite, and an array of biomarkers of inflammation and oxidative stress will be~     made, plus transcriptome (mRNA) analysis. This study will inform a planned larger phase II~     trial.~   "
56371|NCT02319252|"~     The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal~     feeding tubes are the most effect full to feed patients with alcoholic liver diseases and~     non-sufficient oral intake.~      The primary outcome will be differences in nutrition intake between the groups. Secondary~     outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients'~     quality of life, nausea & vomiting.~      The study will include 40 patients at Aarhus University Hospital, Denmark.~   "
56372|NCT02319239|"~     Primary purpose of the study is to develop a stereotactic radiation treatment to prostate~     cancer which minimizes treatment related toxicity. Movement of the prostate during a~     radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This~     data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation~     toxicity to rectum will be reduced by using a rectum fixation during a treatment.~      Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with~     20 x 3 Gy fractionation schedules. With the data collected from these groups treatment~     marginals to prostate will be defined and used to treat group III (40 patients) with 5 x~     7.25 Gy.~      Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging~     could be used to evaluate radiation treatment response in intermediate prostate cancer.~     Androgen deprivation therapy is not allowed in this study.~   "
56373|NCT02319226|"~     Graft-versus-Host Disease (GVHD), is the most frequent and severe complication of allogeneic~     hematopoietic stem cell transplantation (HSCT). Much of our knowledge on the pathophysiology~     of GVHD has been gained from experimental models but far less from the study of the disease~     in humans. Recent developments in basic biology open new avenues to the development of~     biomarker sets that could predict GVHD severity and prognosis that could be tested and~     validated through well-designed multicenter clinical trials.~      The main goal of this project is to further our understanding of the pathogenic mechanisms~     of human GVHD on one hand, and of functional immune tolerance on the other. Furthermore,~     this study aims at setting up a clinically relevant biomarker set in human GVHD and immune~     tolerance in a discovery cohort.~      The objectives of this project are:~      1. To define phenotypic, functional and molecular correlates of acute GVHD early after~     HSCT/at its onset 2. To study thymic reconstitution and the T-cell repertoire after HSCT~     during period 2 3. To identify functional and molecular correlates of immune tolerance in~     long-term survivors of HSCT 4. Preparing for biomarker validation into a clinical trial We~     propose a prospective analysis of a cohort of 680 patients transplanted from an~     HLA-identical sibling donor at Saint Louis hospital. Analyses will be performed during 3~     critical, clinically relevant, periods.~        1. Period 1: Analysis at the onset of GVHD, or at the time of engraftment 30 days after~          HSCT in patients not developing GVHD. An additional blood sample will also be analyzed~          90 days after HSCT.~        2. Period 2: Thymic function analysis using measurements of T-cell receptor excision~          circles (TREC) will be performed at 6 and 12 months post-transplant for all patients.~          T-cell receptor analysis on sorted T-cell populations will be performed by NGS.~        3. Period 3: In tolerant patients (patients more than 2 years after HSCT not requiring~          immunosuppressive treatment), or in patients still requiring immunosuppressive therapy~          after 2 years. We will also analyze the corresponding immune parameters for each donor.~      The longitudinal design of this study will allow us to provide an integrated view of GVHD~     pathophysiology and mechanisms of immune tolerance in human.~      Prospectively identified phenotypic, molecular or functional biomarkers will then be tested,~     in a subsequent study, from biological materials prospectively collected within the French~     wide CryoStem cohort. Thus, as the final task of this project, we will perform statistical~     analyses taking into account confounding clinical variables influencing the outcome (i.e.~     GVHD-related death or tolerance). Preparing for a clinical trial will need moving from~     classical Bioinformatics analyses into clinically relevant statistical analyses that include~     sequential biological measurement in the discovery set cohort. Main points that will be~     taken into accounts for this task are the followings;~        1. Transplant-related mortality (TRM) can be estimated in the range of 20%; 2year~          post-allogeneic HSCT~        2. TRM is mostly (even if totally) due to GVHD and its associated immune deficiency~        3. GVHD cumulative incidence can be estimated in the range of 40%~        4. 80 patients will be prospectively studied and 30 patients will be analyzed (cross~          sectional study) for part 3 only.~        5. Since GVHD-related mortality and tolerance are mutually exclusive situation the optimal~          calculation for the validation cohort can be expected~        6. This calculation will be the basis for the proposal of an interventional clinical~          trial.~   "
56374|NCT02319213|"~     The purpose of this study is to evaluate the changes of intraocular pressure due to the~     increase of intra abdominal pressure.~   "
58105|NCT02296593|"~     Continuous lactate and glucose blood levels~   "
56377|NCT02319174|"~     The purpose of the study is to help make a lower cost automatic blood pressure monitor~     device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic~     blood pressure monitoring is limited or not available. The study will compare this low cost~     device to a commercially available system used for pre-eclamptic women in many United States~     hospitals that the investigators will be bringing to Malawi as a part of this study.~      The team hopes to show that this lower cost blood pressure machine works well and can help~     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse~     to use.~      70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at~     University of Texas Health Science Center Houston. Patient arm circumference will be~     measured with measurement tape.~      They will be seated upright in a comfortable chair with arm at heart level and an arm blood~     pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer~     will be placed on the left arm.~      The cuff will be inflated and then deflated until measurement concludes. Heart rate will be~     measured with tactile arterial palpation.The process will be repeated for a total of up to~     nine measurements, alternating between measurements with the automatic blood pressure~     monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds~     between each measurement.~      The results of this study will help researchers understand the performance and usability of~     this device in Malawi and help decide if any design changes are needed.~   "
56378|NCT02319161|"~     The investigators aimed to investigate the efficacy of calcium channel blockers and beta~     blockers for controlling tourniquet induced blood pressure increase in patients undergoing~     carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation~     under IVRA were retrospectively examined in terms of demographical and hemodynamic~     variables.~   "
56379|NCT02319148|"~     The primary objective of the study is to estimate the effects of different strong enzyme~     (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose~     pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately~     18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to~     determine the safety and tolerability of single-dose PF- 00489791 when it is administered~     with steady-state itraconazole, diltiazem, or verapamil.~   "
56380|NCT02319135|"~     The hypothesis is that the replacement of the standard fludarabine and cytarabine based~     therapy by azacytidine could result in an improvement of RFS and OS rates in the~     experimental arm. To fulfill the medical needs in such frail and elderly population,~     improvements in terms of atileukemic efficacy in the azacytidine experimental arm should be~     attained without increasing the therapy-related toxicity or decreasing the patients QoL.~   "
56381|NCT02319122|"~     The aim of this randomized, stratified, single-blinded study is to compare two home based~     strength-training protocols (High Intensity Interval Training and Progressive Resistance~     Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in~     children with cerebral palsy.~   "
56382|NCT02319109|"~     This is a prospective, single-center study in healthy volunteers to establish a PT/INR~     reference interval for the Microvisk International Normalized Ratio (INR) Test System. The~     primary objective of this study is to establish the reference interval for the measurement~     of prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to~     evaluate the safety of the device.~   "
56383|NCT02319096|"~     Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the~     treatment of SUI. Due to poor motivation and compliance only 15-20% of women comply with the~     regimen. Whole body vibration (WBV) exercise has been developed as a new modality in the~     field of physiotherapy. The Galileo machine is a unique device for applying whole-body~     vibration. The investigators are currently using this therapy as an alternative to~     traditional pelvic floor muscle therapy. The investigators aim to audit the investigators~     treatment of whole body vibration.~   "
56384|NCT02319083|"~     The E-CABG registry is a multicenter, European registry collecting data on the preoperative~     characteristics, treatment strategies and outcome of patients undergoing isolated coronary~     artery bypass grafting (CABG).~   "
56385|NCT02319070|"~     This study is a prospective, single center, observational, 2-cohort study of adult patients~     with severe Hemophilia A. There is no randomization procedure and all patients will be~     treated as per usual clinical practice. Patients will be followed up for 18 months after~     enrolment.~   "
56386|NCT02319057|"~     The purpose of this study is to evaluate ORM-12741 concentrations in the blood after~     different study drug formulations~   "
56387|NCT02319044|"~     The purpose of this study is to determine the efficacy and safety of investigational medical~     products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab~     combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of~     the head and neck who have progressed during or after treatment with a platinum containing~     regimen for recurrent/metastatic disease.~   "
56388|NCT02319031|"~     The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and~     Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic~     Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in~     this study may have already been treated prior for HCV or may have never received treatment~     for their HCV.~   "
56389|NCT02319018|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with combination chemotherapy in treating patients with gastrointestinal tumors. Alisertib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving alisertib with more than one~     drug (combination chemotherapy) may be a better treatment for gastrointestinal tumors.~   "
56390|NCT02319005|"~     The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC)~     in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing~     has been discontinued; patients are being followed-up for safety.~   "
56391|NCT02318992|"~     The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized~     fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C.~     difficile associated diarrhea (RCDAD). We will generate a frozen, lyophilized or fresh fecal~     microbiota transplantation (FMT) inoculum from well-screened healthy volunteer donors of~     ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from~     donors and recipients will be saved for later metagenomic studies to characterize the~     microbiome of the gut in patients before and after FMT.~      Donors will be enrolled and screened at the Center for Infectious Disease laboratory for~     enteric pathogens at University of Texas School of Public Health (EPDL-UT-SPH) which is~     College American Pathologist and Clinical Laboratory Improvement Amendments certified~     laboratory. The donors will come from a variety of places, including the University of Texas~     School of Public Health. We will screen at least 70 donors to recruit at least 20 qualified~     donors.~      Recipients All patients to be treated must have a physician who is willing to care from them~     after discharge from our facility. Recipients will need to have insurance or be willing to~     self-pay for this therapy. Attending physician of recipients/patients will order the FMT and~     make clinical decisions related to overall health for his/her patients. All patients~     undergoing therapy will be handled as outpatients at either Baylor St. Luke's Medical Center~     in the Texas Medical Center, the Digestive Disease Center at Memorial Hermann in the Texas~     Medical Center, or Kelsey-Seybold Clinic - Main Campus on Holcombe Blvd. Once the procedure~     is completed, the recipient will be transferred back to their original medical treatment~     facility or be released to home care under the care of their physician. A gastroenterologist~     with privileges at Endoscopy procedure site will perform the FMT via colonoscopy. The Center~     for Infectious Disease enteric pathogens laboratory at the University of Texas School of~     Public Health will prepare donor stool for administration via a colonoscope. We will screen~     at least 120 recipients to recruit 100 qualified recipients.~      Evaluation of the safety of FMT and recurrence of clinical symptoms of CDAD will be~     performed by the primary physicians and research coordinators from the EPDL-UT-SPH. The~     primary endpoint is to evaluate the safety of the FMT (fresh or frozen or lyophilized health~     donor feces) for the treatment of patients with 3 or more episodes of RCDAD. A second~     efficacy endpoint is to evaluate the recurrence of clinical symptoms and CDAD after initial~     therapy. In order to monitor any health effects for safety, participants will be contacted~     quarterly for three years following study completion. The recipient will be contacted by the~     investigator pre- and approximately 7, 14 and 30 days after the procedure is performed. The~     following procedures will be completed: review recipient diary with the recipient to ensure~     that the following information is recorded correctly and a fresh stool sample will be~     collected from recipient, tested for C. difficile toxins and an aliquot (2 mL) stored at~     -80C for future analysis (e.g. microbiome). The recipients will be contacted by phone for~     their diarrhea status.~   "
56395|NCT02318940|"~     The purpose of this study is to compare the effectiveness and safety of the installation of~     femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark~     method~   "
56396|NCT02318927|"~     The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions~     (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication~     freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from~     these two brain regions after surgery will allow for the development of a personalized DBS~     system to address FoG. The primary outcome will be a comparison of the pre-operative number~     of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at~     the optimized device settings.~   "
56397|NCT02318914|"~     The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers~   "
56398|NCT02318901|"~     There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for~     patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will~     be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus~     ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC.~     There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for~     patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype~     metastatic CRC.~   "
56399|NCT02318888|"~     The study aims at investigating if icodextrin 4% instilled in abdominal cavity during~     surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in~     patients with colorectal cancer. Follow-up data is collected from the Swedish national~     colorectal cancer registry.Patients are followed for 5 years postoperatively.The study is a~     randomized Swedish multicenter study and planned to include 1,800 patients. A safety control~     is planned after 300 included patients.~   "
56400|NCT02318875|"~     Joints and muscles disorders are common symptoms in the population. They are characterized~     by swelling, pain, functional impairment and morning stiffness. These disorders can be~     really disabling and painful, affecting the person's quality life. The purpose of this~     clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154~     subjects complaining functional discomfort associated to joints and muscles disorders.~   "
56401|NCT02318862|"~     Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million~     adults in the U.S., and it significantly impacts patients' quality of life while imposing~     billions of dollars of direct and indirect costs each year upon our healthcare system.~     Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal~     of this project is to develop a novel, minimally invasive Mucosal Impedance technique for~     more accurate detection of GERD while reducing costs.~   "
56402|NCT02318849|"~     Taking advantage of college students' frequent use of online technology, including social~     networking sites (e.g., Instagram a social media site /Facebook a social networking site)~     and social media sites (e.g., YouTube), we will create an online intervention that leverages~     this technology to engage and educate Asian, Native Hawaiian, Pacific Islanders~     (ANHPI)students about a range of topics related to organ donation following death.~   "
56403|NCT02318836|"~     This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult~     subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with~     moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic~     impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function~     with mean age, body mass index (BMI), and gender distribution targeted to be similar to the~     impaired hepatic function cohorts.~   "
56404|NCT02318823|"~     The present study aims to evaluate effects of beer (alcohol) on social cognition.~   "
56405|NCT02318810|"~     Mask ventilation during induction of anesthesia can be improved by administration of~     neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask~     ventilation; however, muscle relaxants may improve mask ventilation and they do not alter~     mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before~     testing mask ventilation. We will study different dosages of rocuronium; we assume that~     higher dosages of rocuronium will improve mask ventilation compared with lower dosages.~   "
56406|NCT02318797|"~     Adults with serious mental illness (SMI) frequently have unmet medical needs which place~     them at risk for adverse health outcomes. While there are proven ways to manage and/or~     prevent serious medical conditions common among this population, information is needed to~     understand their impact on outcomes that matter most for patients, particularly in community~     mental health centers (CMHCs) where most adults with SMI receive their care and rural areas~     where locating and receiving health care services can be challenging.~      The investigators will test two promising ways for promoting the health, wellness, and~     recovery of adults with SMI. One way will help patients manage their health and health care~     through self-management strategies, including the use of a web portal, and peer support~     (patient self-directed care) and the other through interactions with nurses during clinic~     visits (provider-supported integrated care).~      The investigators will compare the two interventions on three primary patient-centered~     outcomes (i.e. patient activation in care, health status, engagement in primary/specialty~     care). The investigators hypothesize that:~        1. Patient self-directed care will result in improvement in patient activation.~        2. Provider-supported integrated care will result in greater improvement in frequency in~          primary/specialty care visits.~        3. Both interventions will result in significant improvements in the three primary~          outcomes.~      The investigators will collect information from patients, caregivers, and clinic staff at~     different points in time during the study. Patients will be asked to complete questionnaires~     and additional data on their service use will be gathered. Some patients and providers will~     also be interviewed about their experiences with care. The investigators will examine these~     data to learn if, how, and why the new services improve outcomes over time. This information~     will help us understand patient and other stakeholder views about the services and, if~     appropriate, ensure their continued and/or expanded availability.~   "
56407|NCT02318784|"~     The purpose of this study is to determine if carfilzomib is safe and effective in the~     treatment of patients with advanced neuroendocrine tumors.~   "
56408|NCT02318771|"~     This randomized clinical trial studies radiation therapy and MK-3475 in treating patients~     with head and neck cancer, kidney cancer, melanoma, or lung cancer that has returned, has~     spread to other parts of the body, or cannot be removed by surgery. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as MK-3475, may block~     tumor growth by targeting certain cells and causing the immune system to attack the tumor.~     Studying the effects of MK-3475 with radiation therapy on the body may help doctors learn~     whether it may be an effective treatment for these solid tumors.~   "
56409|NCT02318758|"~     A study to assess the interaction of acohol and oral treprostinil.~   "
56482|NCT02317796|"~     A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study~     of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes~   "
56483|NCT02317783|"~     The initial goal of the investigators interdisciplinary group of imagers, oncologists,~     neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot~     data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and~     Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot~     study.~      The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand~     CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant~     chemotherapy.2,3 To date there have been few studies examining this problem using~     multi-modality imaging techniques to better understand this complex and significant problem.~      FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive~     dysfunction in older populations complaining of memory dysfunction. It is well recognized~     that FDG-PET can assist with the differentiation and characterization of various cognitive~     disorders due to unique patterns of cerebral metabolism caused by various cognitive and~     dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and~     has a high reliability in detecting Alzheimers disease (AD) many years before it can be~     diagnosed reliably using clinical criteria.4~      To the investigators knowledge, there has been only a single small study using FDG-PET and~     bolus water activation paradigms in cancer patients complaining of memory problems.7 To~     date, there have been no studies using Flutemetamol as a PET imaging agent to assess the~     possibility of increased amyloid plaque burden as a potential contributing factor to the~     cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of~     this project is in the combined use of Flutemetamol-PET, FDG-PET, and anatomic MRI to study~     a poorly understood but common problem: cognitive impairment in breast cancer patients~     treated with chemotherapy.~      If Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this~     disorder, it will be an important step in better understanding the etiology of this~     phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging~     assessments will make it possible to explore any altered changes in cerebral structure,~     metabolism, and amyloid deposition that may be responsible for CICI. This may help to~     predict which individuals may be affected by this problem and provide information for~     eventual therapeutic strategies to treat this common cancer-associated disorder.~      This study will use Flutemetamol and FDG-PET imaging to assess and quantify the amyloid~     plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients~     suffering from CICI and correlate those findings with structural changes on MRI. The~     Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE~     software databases (NeuroMarQ and Cortex ID) which contain scan data from healthy control~     individuals to evaluate for abnormalities in cerebral glucose metabolism and amyloid plaque~     burden differing from the values expected for individuals in their age range.~   "
56484|NCT02317770|"~     This study compares the effect of nebulized lidocaine and lidocaine spray in patients~     undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the~     procedure between two methods.~   "
56410|NCT02318745|"~     This study seeks to investigate the efficacy and mechanisms of a highly promising~     Culturally Informed Family Therapy for Adolescents in preventing the emergence of two~     important health disparities in Hispanic youth, namely drug use & HIV and other sexually~     transmitted infections (STI). The proposed study is submitted as part of a P60 application~     entitled NCMHD Center for Culturally-Tailored Hispanic Health Disparities Research (El~     Centro), in response to the NIH RFA-MD-06-002: Establishing Comprehensive NCMHD Research~     Centers of Excellence.~      This study investigates: 1) the efficacy of the treatment in reducing existing psychiatric,~     behavioral and family problems in youth, and 2) the indicated prevention effects of the~     intervention on the emergence of drug use and HIV/STI 20 months after baseline. There is a~     substantial literature linking disruptive behaviors (i.e., conduct disorder and attention~     deficit hyperactivity disorder) and mood instability (i.e., depressive disorders) and family~     conflict to the development of the Hispanic health disparities of drug use and HIV/STI.~     Conduct disorder (CD), attention deficit hyperactivity disorder (ADHD) and depressive~     disorders (DD) will be targets of treatment, as will be the family risk factors (e.g., poor~     parenting, family conflict) and acculturation-related stressors, all of which have been~     shown to place youth on a destructive trajectory toward deteriorating health.~   "
56411|NCT02318732|"~     This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and~     risk of future violence and other important outcome events among individuals who legally~     purchased firearms in the past but have since become prohibited from owning them. The main~     hypothesis is that APPS will be associated with a significant reduction in risk for future~     violence among individuals who are directly affected.~   "
56412|NCT02318719|"~     Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia~     (PHN) in comparison to placebo~   "
56413|NCT02318706|"~     Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral~     Neuropathic Pain (DPNP) in comparison to placebo~   "
56414|NCT02318693|"~     This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment~     on the glucose variability using continuous glucose monitoring (CGM) in Japanese~     participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment~     with sitagliptin will be superior to treatment with glibenclamide in the change from~     baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose~     monitoring (CGM) after 13 days of treatment.~   "
56415|NCT02318680|"~     The study aims to assess whether a follow home visit after discharge of frail elderly~     patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.~      Staff from the hospital ward identifies patients fulfilling the inclusion criteria and~     refers the patients to two project nurses at the hospital (follow home team). One of the~     project nurses gets the informed consent from the patient, or in case of a patient who is~     not able to give informed consent, from the family and general practitioner. The patient is~     then randomized to intervention (follow home visit after discharge) or control.~      In the intervention group, the hospital project nurse and the patient meets with the~     municipal nurse in the patient's home on the same day the patient is being discharged from~     the hospital. During this visit the discharge from the hospital and the actual functioning~     of the patient in his own surroundings is reviewed, using a structured assessment.~   "
56416|NCT02318667|"~     The purpose of this study is to evaluate serum soluble human Suppression of Tumorigenicity 2~     (ST2) protein, the receptor for IL-33 and a member of the proinflammatory IL-1 receptor~     superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic~     response to golimumab treatment in subjects with moderate to severe UC who have failed on~     prior conventional therapies. The primary endpoints of this study are to correlate serum~     soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and~     histological activity (Geboes index) of disease.~   "
56417|NCT02318654|"~     The primary objective of this study is to compare the efficacy of ice pack to topical~     eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary~     hair removal.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
56418|NCT02318641|"~     Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik,~     Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and~     automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is~     estimated by spectrophotometric analysis of light reflected from retinal vessels and from~     the immediately surrounding retina. Oxygen saturation measurements are made on major~     temporal arteries and veins. Briefly, the first and second degree vessels are used, with the~     addition of third degree vessels in images where peripapillary haemorrhage prevented~     analysis close to the optic disc. Vessel segments chosen for analysis are used consistently~     for consecutive measurements in the same retina.~   "
56419|NCT02318628|"~     The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular~     health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera~     system and the classic carotid-femoral Pulse Wave Velocity (PWV).~   "
56420|NCT02318615|"~     The purpose of this comparable cohort study is to evaluate the efficacy and safety of~     immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema~     prevention in breast cancer patients who are undergoing axillary dissection.~   "
56421|NCT02318602|"~     This is a multicenter, open-label trial to assess the long-term safety and efficacy of~     Cannabidiol Oral Solution as adjunctive therapy for pediatric and adult subjects with~     treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet~     syndrome (DS). All participants have rolled over from previous trials: INS011-14-029~     (NCT02324673), INS011-14-024 (NCT02318537), or INS011- 14-025 (NCT02318563).~   "
56422|NCT02318589|"~     This Phase I trial will establish the recommended phase II dose of eribulin in combination~     with fixed doses of oral irinotecan in adolescents and young adults with relapsed or~     refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a~     21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be~     assigned an eribulin dose level at the time of enrollment using a 3 + 3 Phase I design.~   "
56423|NCT02318576|"~     This study seeks to examine whether 12 weeks of home-based computerized cognitive training~     on Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons~     with MS.~   "
56424|NCT02318563|"~     This Phase 3 study will enroll subjects diagnosed with Dravet Syndrome (DS) who are still~     experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components~     (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and~     meet the other inclusion/exclusion criteria.~      Following a 28-day baseline period, subjects will begin an 84-day treatment period.~     Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral~     solution at the highest dose determined to be safe in a previous trial.~      Following study completion, all subjects will be invited to receive Cannabidiol Oral~     Solution in an open label extension study (under a separate protocol).~   "
56425|NCT02318550|"~     The purpose of the registry is to accumulate pre-and post-scan device interrogation data for~     the purpose of determining the risk of MRI for patients with implantable devices.~   "
56426|NCT02318537|"~     This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who~     are still experiencing at least 4 motor seizures involving the trunk or extremities per~     week, despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet~     inclusion/exclusion criteria.~      Following a 28-day baseline period, subjects will begin an 84-day treatment period.~     Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral~     solution at the highest dose determined to be safe in a previous trial.~      Following study completion, all subjects will be invited to receive Cannabidiol Oral~     Solution in an open label extension study (under a separate protocol).~   "
56427|NCT02318524|"~     Fungal infections could play a role in chronic obstructive pulmonary disease (COPD)~     patient's exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is~     often isolated from respiratory samples, but few data are available about its clinical~     significance. Aspergillus colonization could be associated to a higher risk of invasive~     pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence~     (probably underestimated) and a high mortality (72 to 95%). Similarly, detection of~     anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and~     usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore,~     several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with~     a higher frequency in the most severe COPD stages and a possible role of colonisation in the~     occurrence and progression of COPD.~      As these colonization and sensitization phenomena could be related to domestic exposure to~     airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in~     order to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal~     colonization and sensitization frequency in COPD patients, (ii) Study the relationship~     between these fungal colonization/sensitization phenomena and lung function impairment in~     the course of COPD and (iii) Have a better understanding of mould and P. jirovecii~     circulation in the close environment of patients (between airborne, human reservoirs and~     patients).~      In fine, this study will provide data (i) On fungal contamination levels (species and~     conidia concentration) of COPD patient's homes in a French region, (ii) On the relationship~     between fungal exposure level and colonization/sensitization phenomena, (iii) On the role of~     fungal colonization/sensitization in lung function impairment, (iv) To design diagnostic,~     therapeutic, and preventive options for the management of COPD patients, taking into account~     fungal environmental exposure and colonization/sensitization impact on the evolution of the~     disease.~   "
56428|NCT02318511|"~     This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of~     Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3~     groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid~     (HA) injection - with commonly used injection material and 3) Saline. After treatment,~     patients will be followed up to 12 months to evaluate improvements using common pain and~     function subscales.~   "
56429|NCT02318498|"~     Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8~     % of all myocardial infarctions). There are several different causes behind MINCA where~     true infarction due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are~     the main findings. The underlying diagnosis is often made by clinical findings sometimes~     with the help of cardiac MRI (CMR). Investigators have previously shown that it was possible~     to give 50 % of the patients a diagnosis made by the combination of clinical findings and~     CMR made in median 12 days after the acute event. The present study aim at improve the~     diagnostic accuracy by an early CMR with latest technique.~   "
56430|NCT02318485|"~     This project aims to conduct a multicentre human clinical trial to effectively diagnose and~     treat limbal stem cell deficiency (LSCD) which can be caused by a number of different~     disease processes, all of which have a common denominator, i.e. a loss of the normal~     functioning epithelial stem cells of the cornea. A number of different diseases such as~     aniridia, steven johnson's syndrome, ocular cicatricial pemphigoid, bacterial keratitis, or~     chemical and thermal injuries to the cornea can lead to gradual loss of its functioning~     epithelial stem cells. This leads to vascularization of the cornea with surrounding~     conjunctival epithelium growing over it resulting in its scarring and opacification. These~     corneas, since vascular, no longer retain their immune privilege and prove extremely~     challenging to the ophthalmic surgeon. Grafting donor corneas which in normal circumstances~     (non vascular corneas) would give excellent results, exhibit high rates of rejection. This~     can be very frustrating for both the patient as well as the surgeon. Since there are a~     number of different contributing disease pathologies, our estimate is that there are~     approximately 100 patients per year in Belgium that suffer from some degree of LSCD. These~     patients are very often not correctly diagnosed since this is a relatively new disease first~     described in 1990 after the discovery of limbal epithelial stem cells in 1989. The low rates~     of diagnosis could potentially be increased by in vivo confocal scanning microscopy as a non~     invasive screening test to detect early signs of LSCD and therefore offer conservative~     treatment options. In the cases where total limbal stem cell deficiency has already~     developed, conventional corneal grafting is not suitable due to the high vascularity of the~     host bed. In this situation we propose transplanting standardized limbal epithelial stem~     cell grafts generated from the patient's own ocular stem cells (from the good eye, where~     available) or from HLA matched donors. Tiny 1 by 2mm superficial limbal (peripheral cornea)~     biopsy can be taken and the epithelial stem cells expanded in the laboratory on a biological~     substrate, until there is a graft measuring >8mm in diameter generated in 2 a week period.~     This can then be transplanted onto the diseased eye after removal of scar tissue using a~     novel surgical technique we have developed.~   "
56431|NCT02318472|"~     The purpose of this study is to determine whether early mobilization after Achilles tendon~     rupture can speed up healing and improve patient outcome.~   "
56432|NCT02318459|"~     This is a pilot study for evaluating the feasibility of using High Intensity Interval~     Training in geriatric hospitalized patients compared to the standard current rehabilitation~     practice.~   "
56433|NCT02318446|"~     The present study is planned to study effect of folic acid supplementation on homocysteine~     levels and CV risk factors such as BP and lipids in adolescent epileptics taking~     anti-epileptic drugs (AEDs).~   "
56434|NCT02318433|"~     The primary aim of the study is to see if a single wrist injection (intra-articular) of~     dexamethasone at the time of treatment will reduce the incidence of early-onset of post~     traumatic osteoarthritis.~   "
56485|NCT02317757|"~     These days, there is higher proportion of elderly cancer patients. Most of them have~     comorbidities, borderline performance status and nutritional status. The discontinuation of~     chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric~     assessment might be beneficial in selection of suitable elderly patients for chemotherapy~     administration.~   "
56435|NCT02318420|"~     OVERALL OBJECTIVE In an East African referral hospital, to analyze the effect on quality of~     intrapartum care when implementing first locally agreed and achievable guidelines and a~     continual in-house training program and later on converting the guidelines to an eHealth~     solution for strengthening partogram-based monitoring-to-action during labour.~      INTERVENTIONS 1. WHO paper partograms, locally developed labour management guidelines and~     continual in-house education. 2. A low-tech triage system for intrapartum care, based on the~     locally developed guidelines. 3. An eHealth solution in supportion partogram-associated~     monitoring-to-action during labour.~      OVERALL DESIGN Three intervention-based pre vs. post studies. SETTING Department of~     Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.~      POPULATION Labouring women delivering at the study site from October 2014 to April 2017 and~     their offspring, as well as health providers. Women and their offspring will be enrolled~     at/after unset of labour and followed until discharge.~      ENDPOINTS The primary endpoint is perinatal mortality occurring intra-hospital. For~     secondary outcomes, please see below.~      STUDY TIME Data collection from September 2014 to April 2017.~   "
56436|NCT02318407|"~     This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose~     escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects~     will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4~     doses (Q28D x 4).~   "
56437|NCT02318394|"~     To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced~     solid tumors~   "
56438|NCT02318381|"~     Aim of this prospective double blind randomized clinical trial is to understand the~     correlation of suprascapular neuropathy in the setting of large and massive tears of the~     shoulder rotator cuff and to investigate whether arthroscopic dissection of the superior~     transverse scapular ligament is positively related to the improvement of this neuropathy.~   "
56439|NCT02318368|"~     Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and~     safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with~     previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.~   "
56440|NCT02318355|"~     This study is a randomized control trial in volunteer blood donors to quantify the effect of~     blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation~     such as base deficit and lactate.~   "
56441|NCT02318342|"~     This is a prospective study designed to evaluate the structural and functional integrity of~     transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further~     aims to confirm resolution of the early bioprosthetic valve thrombotic changes with Vitamin~     K antagonists (warfarin) mediated anticoagulation therapy.~   "
56442|NCT02318329|"~     This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients~     will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the~     study, but not both.~   "
56443|NCT02318316|"~     The most effective treatment of hematologic malignancies and some benign hematological~     diseases is allogeneic stem cell transplantation therapy. Pulmonary complications can occur~     after allogeneic stem cell transplantation. And these complications effect mortality and~     morbidity in these patients. In this study we want to investigate the use of exhaled breath~     condensate (EBC) collection which is a simple and completely noninvasive method. By this way~     we hope to detect pulmonary complications early. EBC, has been implicated in the~     pathophysiology of inflammatory airway diseases such as cystic fibrosis, asthma, chronic~     obstructive pulmonary disease (COPD) and bronchiectasis. EBC, has not been investigated~     before in patients who underwent stem cell transplantation.~   "
56444|NCT02318303|"~     Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in~     treatment of seasonal allergic rhinitis.~   "
56445|NCT02318290|"~     Critically ill patients who are mechanically ventilated may require prolonged administration~     of sedatives and analgesics. Their prolonged use has been associated with withdrawal~     symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be~     associated with adverse clinical outcomes. Although well studied in the paediatric~     population, little is known about the epidemiology, risk factors and optimal screening~     methods in adults. Studying this problem is essential as we strive to develop proper weaning~     strategies.~      Methods: Prospective observational two-center study in critically ill adult patients~     Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics~     in critically ill adult patients and 2) Evaluate the performance of screening tools~     assessing withdrawal that were developed for the paediatric patient in the adult population.~   "
56446|NCT02318277|"~     The purpose of this study is to explore the safety, tolerability, pharmacokinetics,~     immunogenicity and preliminary efficacy of INCB024360 administered in combination with~     MEDI4736 in subjects with selected advanced solid tumors.~   "
56447|NCT02318264|"~     This cross over design study will be used to determine the influence of elastic kinesiology~     tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected~     resisted and weight bearing exercises.~   "
56448|NCT02318251|"~     The purpose of the present study is to compare two different physiotherapy programs~     regarding their effect on stress urinary incontinence.~   "
56449|NCT02318238|"~     The purpose of this study is to find an alternative to the six minute walk test by~     validating six minute step test and four metre gait speed in healthy children. Both tests~     were previously validated in adults and are easier to achieve in non-hospital settings.~   "
56450|NCT02318225|"~     The aim of this study is to assess whether vaginal misoprostol reduces pain during office~     hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable~     pain.~   "
56451|NCT02318212|"~     International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT®~     for cervical priming prior to induced abortion.~   "
56452|NCT02318199|"~     Emergence agitation is a frequent complication that can have serious consequences during~     recovery from general anesthesia. However, agitation has been poorly investigated in~     patients after craniotomy. In this prospective multicenter cohort study, adult patients will~     be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk~     factors and outcome will be investigated.~   "
56486|NCT02317744|"~     This study will test the effectiveness of the combination of Naltrexone and Bupropion~     relative to placebo for reducing binge eating in persons with obesity and binge eating~     disorder.~   "
56453|NCT02318186|"~     Abstract~      This is a multi-center, open-label pharmacokinetic (PK) study examining the relationship~     between the steady-state plasma concentration and dose of treprostinil delivered~     intravenously or subcutaneously in children with pulmonary arterial hypertension (PAH).~     Subjects will be divided into 5 cohorts by age. A blood sample will be obtained from each~     subject at steady state. Additional blood samples will be obtained from a small subset of~     subjects with a 15% increase or with at least a 15ng/kg/min increase in dose from steady~     state. Samples will be sent to a pharmacokinetic laboratory for analysis. Linear regression~     analysis will be used to determine the relationship between the steady state plasma~     concentration and drug dose. A power model will be used to assess dose proportionality.~   "
56454|NCT02318173|"~     International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT®~     osmotic dilator for cervical ripening prior to labour induction.~   "
56455|NCT02318160|"~     Oxidative status in autoimmune thyroiditis was not investigated previously in children and~     adolescents. We investigated oxidant and antioxidant systems in a cohort of Egyptian~     children and adolescents with AIT to explore their relation with biomarkers of autoimmunity~     and thyroid function.~   "
56456|NCT02318147|"~     Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal~     barrier dysfunction and increased intestinal permeability was associated with bacterial~     translocation which is believed to prompted these infections.The purpose of this clinical~     trail is to observe the potential capability of FMT in reduce the bacterial translocation~     and alleviate infectious complications by the reconstruction of a gut functional state.~   "
56457|NCT02318134|"~     The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis~     and protecting the gut against pathogens by competing for nutrients, creating the intestinal~     biological barrier and modulating the host immune system.After the onset of acute~     pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result~     in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial~     and endotoxin translocation, which may cause infectious complications which are major causes~     of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of~     gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora~     disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the~     mechanism by which FMT results in cure of diseases has been poorly understood.This study~     aims to investigate the therapeutic potential of FMT for SAP patients with intestinal~     barrier dysfunction.~   "
56458|NCT02318121|"~     Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and~     morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful~     contractions accompanied by cervical dilatation where labour is longer than 24~     hours.prolonged active phase should not last longer than 12 hours without full assessment in~     a facility able to offer management and treatment of complications.Causes of prolonged~     labour usually due to poor or uncoordinated uterine action , fetal head malposition , and or~     abnormal pelvis either due to bone or soft tissue obstruction.~      Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is~     also associated with increased pain and negative birth experience. Women with a prolonged~     first stage of labor have experienced a higher rate of postpartum hemorrhage,~     chorioamnionitis and neonatal admission to the intensive care unit.~      Caesarean section rates are over 20% in many developed countries and have increased nearly~     four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis~     contributing to this increase is dystocia or prolonged labor.Data obtained from local~     hospital records showed that Caesarean section rate in Assiut University Women's Health~     Hospital is 47.96% at 2013.~      Dystocia is a term used for delay of labor progress and usually refers to abnormally slow~     cervical dilatation.It has been proposed that the partogram should include, as a diagnostic~     criterion, a 1 cm/hour line originating at admission. The World Health Organization has~     proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or~     more.~      Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in~     the modern obstetric practice to treat a slow labour, although the timing of oxytocin~     initiation and amniotomy may vary widely.This intervention is based on the hypothesis that~     the most frequent cause of dystocia is inadequate uterine contraction.~      The mechanism by which amniotomy speeds up labour remains unclear it is thought that when~     the membranes are ruptured ,the production and release of prostaglandins and oxytocin~     increases resulting in stronger contractions and quicker cervical dilatation. I has been~     found that early intervention (augmentation versus routine care ) with amniotomy and~     oxytocin to be associated with a modest reduction in the risk of caesarean section.~     Moreover, amniotomy found to be associated with an increased risk of cesarean delivery~     compared with women without amniotomy for shortening of spontaneous labour.~      The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different~     settings without a real conclusion which is better.~   "
56459|NCT02318108|"~     The purpose of this study is to test the effectiveness and cost effectiveness of an assisted~     work process redesign intervention in achieving improved diabetes care in primary care~     practices. The strategies that we will test represent a novel method for assisting practices~     in developing the skills to overcome clinical inertia and health care system barriers to~     improved diabetes care by helping them to implement and use a diabetes registry to identify~     needed clinical or preventive services an opportunities for treatment intensification where~     appropriate for their patients with diabetes. This is accomplished by helping practices~     develop methods for improving the efficiency and effectiveness of clinical care processes~     through integration of a diabetes registry into regular clinical practice. This integration~     is accomplished through changes in the work processes in the practice setting to ensure that~     population health tasks (such as outreach to patients who do not attend scheduled chronic~     care visits and systematic identification for follow up of patients who may not be taking~     prescribed medication therapies) become a part of the regular work of clinical support staff~     and other members of the primary care practice team.~   "
56460|NCT02318095|"~     This research protocol will evaluate the feasibility of administering neoadjuvant~     gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated~     radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer~   "
56461|NCT02318082|"~     This research study is a way of gaining new knowledge about the treatment for cGVHD that has~     not responded to steroids. This research study is evaluating a drug called Interleukin-2~     (IL-2) as a possible treatment for cGVHD. In this Phase I study, the investigators are~     looking to see if 8- week individual patient dose- escalated IL-2 therapy for cGVHD is safe~     and its effects on your immune cells.~   "
56487|NCT02317731|"~     The purpose of this study is to determine whether patients drinking their bowel preparation~     solution with a straw will have improved tolerability for ingestion of their bowel~     preparation solution and achieve a higher bowel preparation quality score than patients~     drinking their bowel preparation solution without a straw.~   "
56565|NCT02316704|"~     The primary objective of this project is to investigate, using RSA, acetabular implant~     migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7~     acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the~     largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7~     acetabular system with endpoint assessment being performed at the 2 year follow-up.~   "
56462|NCT02318069|"~     The risk for tick borne encephalitis increases in Sweden. Together with an increased~     awareness of the possibility to acquire protection by vaccination, this has led to an~     increase in the number of doses of the vaccine distributed in Sweden each year - now being~     approximately 400.000. The first year, two doses with an interval of 1 month is recommended~     for the general population, followed by a third dose approximately one year later and an~     additional booster dose three years after the third.~      Preliminary results from a previous study showed a higher percentage protected (=titer at~     least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31,~     unpublished information). In the same study, there were no differences between those who~     were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked~     differences between 2 and 3 doses also in the younger control group.~      The investigators therefore aim to confirm results in a new study and to add a group with a~     double dose at day 0 and then a single dose at day 30 and 360~   "
56463|NCT02318056|"~     Specific Aim 1: To determine if one of three burn dressings provides a less painful healing~     experience for partial thickness hand.~      Specific Aim 2: To evaluate if one of three dressings provides greater functionality during~     and after healing of partial thickness hand burns.~      Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior~     healing results for partial thickness hand burns.~   "
56464|NCT02318043|"~     Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but~     relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation~     test (BPT) in asthma is not fully elucidated.~      The investigators aimed to compare both BPTs and determine their usefulness in reflecting~     changes of asthmatic symptoms.~      BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting~     20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients~     with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor~     responders. Patients with uncontrolled and partly controlled asthma, who maintained their~     original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness~     and asthmatic symptoms 3 and 6 months after.~   "
56465|NCT02318030|"~     Adequate control of immunosuppression is critical in preventing graft failure after solid~     organ transplantation (SOT) and in avoiding life-threatening viral and malignant~     complications. Prolonging patient and graft survival and delaying re-transplantation as~     children reach adulthood is critical to optimal use of a scarce resource. This requires~     tailoring post-transplant management to the unique needs of the child. Immunosuppression~     management is challenging in infants, children and youth. The interval from birth to young~     adulthood sees profound changes in physiological processes, body size and immune maturation;~     infancy and adolescence are the periods of most rapid and dramatic change. Three pivotal~     factors affect immunosuppression control in the child: 1) age-dependent variation in drug~     metabolism; 2) developmental changes in immune function with increased childhood~     susceptibility to infections, including those caused by viruses; and 3) behavioural changes~     in adolescence and young adulthood linked with poor treatment adherence.~      This project will identify the most important factors influencing immunosuppression control~     across the pediatric age range, from infancy to young adulthood, including age-related~     changes in drug metabolism, immune function, and susceptibility to viral infections, as well~     as health care system factors affecting treatment adherence. This is the first~     comprehensive, multi-organ transplant study to identify age-related biologic and health care~     systems determinants of variability in immunosuppression control in children and youth.~     Results will inform personalized age-appropriate strategies to improve immunosuppression~     control and reduce the unacceptably high graft failure and viral complication rates in this~     vulnerable population.~      The POSITIVE Study brings together researchers across Canada and is one of 6 projects and 3~     cores that constitute the Canadian Institute of Health Research (CIHR) funded~     interdisciplinary research program called the Canadian National Transplant Research Program~     (CNTRP). The CNTRP is a national program designed to increase organ and tissue donation in~     Canada and enhance the survival and quality of life of Canadians who receive transplants. As~     a national program, CNTRP provides robust power for pediatric studies that would not~     otherwise be possible. While primarily focused on issues unique to a pediatric and young~     adult population, this study will interact closely with all other CNTRP projects. These~     reciprocal interactions will accelerate new discovery that can be cross-applied in different~     populations outside of pre-specified age groups. Interactions will ensure rapid knowledge~     transfer, uptake and dissemination into practice. This is the largest national cohort study~     of pediatric transplant patients to date in Canada, and it will create a longitudinal~     dataset with clinical and biological specimens linkable to transplant registries and~     provincial administrative datasets.~   "
56466|NCT02318017|"~     In the current study, we will administer three widely administered cognitive tasks while~     simultaneously measuring electroencephalography (EEG) in ADHD patients before and after~     methylphenidate immediate release (IR) treatment compared to placebo. In addition we will~     compare the effective connectivity dynamics to normal subjects. Using this novel network~     analysis approach, we will attempt to address the currently limited cognitive network~     literature. We will attempt to map the connectivity between the discrete brain regions~     during the execution of the tasks before and after treatment with methylphenidate IR.~     Comparison with healthy control subjects will enable us to determine whether the direction~     of methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward~     or away from normal connectivity patterns. We will also examine whether network patterns~     differ between the healthy controls and the ADHD patients.~   "
56467|NCT02318004|"~     The aims of the present study are to evaluate the information obtained by the EarlySenese~     monitoring system and examine correlation of the obtained data and clinical events.~   "
56468|NCT02317991|"~     The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab~     (Cyramza®) are effective when used in combination for treating patients with metastatic~     gastroesophageal cancer who have either progressed or not responded to prior therapy.~   "
56469|NCT02317978|"~     Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection~     (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity~     index (FSI) will be calculated and correlated with pregnancy.~   "
56470|NCT02317965|"~     The purpose of this study is to detect whole chromosome abnormalities in maternal blood.~   "
56471|NCT02317952|"~     The purpose of this study is to determine if a new extensively hydrolyzed formula can be~     consumed by children with Cow's Milk Allergy.~   "
56472|NCT02317939|"~     A two-step multi-centre study with 240 rheumatoid arthritis patients.~   "
56508|NCT02317458|"~     This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the~     treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.~   "
56559|NCT02316782|"~     The purpose of this research study is to determine if Intravascular Ultrasound (IVUS)~     grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the~     location, amount, and type of a blockage than angiogram alone. Additionally, this study is~     to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long~     term procedural outcome vs. bifurcation stenting with only angiographic guidance in native~     coronary arteries.~   "
56473|NCT02317926|"~     The proposed study design is a prospective, randomized, double-blind, crossover study. After~     informed consent is obtained, patients will be randomized to receive either desiccated~     thyroid in capsules, or L-T4/L-T3 (ThyrolarTM) in capsules, or L-T4 alone capsules. All~     study participants, physician investigators, those administering the neurocognitive tests~     and those analyzing test results will be blinded throughout the study.~      Subjects will undergo memory testing, a disease specific symptom questionnaire, a general~     mental health assessment, a complete physical examination, baseline EKG, and biochemical~     testing consisting of serum TSH, free T4, total T4, total T3, free T3, T3 resin uptake,~     reverse T3, sex hormone binding globulin (SHBG), serum iodine, a lipid panel, insulin,~     glucose and leptin. This testing and DXA scan of body composition will be performed at~     baseline and after each 3 month treatment period. Deiodinase type 2 (DIO2) polymorphisms~     analyses - will also be performed at the beginning of the study and the results will be~     blinded to the investigators performing the memory testing.~      After 5-6 weeks on the study medication, TSH levels will be checked and the medication~     adjusted to maintain TSH level between 0.46-4.68 mIU/L. Once the TSH level is in the desired~     range, subjects will continue the medication for an additional 6 weeks. Subjects will then~     be crossed-over to the other treatment arm for 3 months. Again, testing will be performed~     after each treatment period. Finally the subjects will again switched over to the 3rd arm~     and testing will be performed after treatment period.~      A cross-over design is preferred because we are assessing subjective symptoms such as~     clinical well-being and other parameters. Therefore, we will be able to evaluate the~     effectiveness of L-T4/T3 (ThyrolarTM) vs DTE vs T4 alone in the same patientssubjects. This~     is also supported by the previous study by Escobar-Morreale et al.~      Additionally, the Wechsler memory scale, DEXA for body composition, measurment of reverse~     T3, insulin, leptin, and DIO2 polymorphisms analysis will be included for the research~     portion of this study. Further, the frequency of serum blood draws, for research purposes,~     will be at intervals of 0, 6, 12, 18, 24, 30 and 36 weeks.~   "
56474|NCT02317913|"~     To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008~     through 2012, and illustrate the risk factors of coronary arterial lesions .~   "
56475|NCT02317900|"~     Dengue viruses are widespread in most tropical and subtropical regions of the world. This~     study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005)~     against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy~     adults.~   "
56476|NCT02317887|"~     Background:~      - X-linked juvenile retinoschisis (XLRS) is caused by changes in the RS1 gene. These changes~     cause abnormal function of the eye protein retinoschisin. Without normal retinoschisin, the~     layers of the retina split and vision is lost. Researchers want to try to introduce a~     healthy RS1 gene into eye cells, to see if this helps retinal cells make healthy~     retinoschisin. They will put the gene in a virus. The gene and virus package is known as a~     gene transfer vector (AAV-RS1 vector).~      Objectives:~      - To see if the AAV-RS1 vector is safe to use in people.~      Eligibility:~      - Adults 18 and older with a mutation of the RS1 gene, 20/63 vision or worse in one eye, and~     XLRS.~      Design:~        -  Participants will be screened with genetic tests to confirm XLRS. They will have a~          medical history and physical and eye exams.~        -  At visits 1-2, participants will have some or all of the following:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Tuberculosis skin test~        -  Eye exam~        -  Vision tests (for one test an intravenous line will be placed in the arm. A dye will be~          injected that will travel to the blood vessels in the eye).~        -  At visit 3, the AAV-RS1 vector will be injected with a needle in the study eye.~          Participants pupils will be dilated. They will get numbing eye drops.~        -  Visits 4-13 will occur in the 18 months after gene transfer. Many of the above tests~          will be repeated. Participants will discuss any side effects.~        -  Visits 14-17 will occur yearly between years 2 and 5.~        -  After year 5, participants will be contacted yearly by phone for up to 15 years.~   "
56477|NCT02317874|"~     This phase I trial studies the side effects and best dose of talazoparib when given together~     with carboplatin and paclitaxel in treating patients with solid tumors that have spread to~     other places in the body or cannot be removed by surgery. Talazoparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving talazoparib with carboplatin and paclitaxel may kill more tumor~     cells.~   "
56478|NCT02317861|"~     The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK),~     safety, and tolerability of multiple doses of RDEA3170 administered in combination with~     febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in~     Japanese adult male subjects with gout or asymptomatic hyperuricemia.~   "
56479|NCT02317848|"~     The prevalence of sleep-disordered breathing is common in patients with stable chronic heart~     failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS)~     and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS~     is associated with higher mortality.~      CHF is associated with a high rate of re-hospitalization and significant morbidity and~     mortality and is considered as a major medical and economic problem. To date, few studies~     have investigated the prevalence, severity, persistence and the role of SAS during cardiac~     decompensation. For different pathophysiological considerations, it is assumed that SAS is~     exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This~     assumption has been questioned recently by some studies which showed stability of the type~     of SAS and its severity between the decompensation episode and the stable HF.~      Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of~     severity and type at three months of decompensation. Thus early polygraphy may be reliable~     for identifying HF patients with SAS.~   "
56480|NCT02317835|"~     To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot~     Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.~   "
56481|NCT02317809|"~     Some women cannot have children because they cannot produce enough follicle stimulating~     hormone (FSH) and luteinising hormone (LH). When this happens the ovaries fail to produce an~     egg during the menstrual cycle - a condition known as anovulation. Anovulation can be~     treated by giving replacement FSH and LH. Pergoveris is a medication that contains both FSH~     and LH. It is used for the treatment of anovulation in women who do not produce enough FSH~     and LH.~      A new, liquid formulation of Pergoveris is being tested in this study. It will be compared~     with the current freeze-dried marketed formulation to see if the new formulation gets into~     the blood stream as easily as the current formulation.~      This study will involve 38 healthy female subjects and 2 treatment periods and will last for~     approximately 77 days. Each subject will receive a single dose of the new liquid formulation~     and a single dose of the current marketed formulation separated by an interval of two weeks~     in a randomised (by chance) order. Blood samples will be taken at regular intervals over 2~     weeks after each dose to measure levels of FSH and LH.~      To participate female subjects must have normal ovaries on internal ultrasound scan, a~     normal result from a cervical smear test, be taking the combined oral contraceptive (OC)~     pill.~      Eligible subjects will have their usual OC pill replaced with another called Marvelon~     throughout the study. After 14 days subjects will have their levels of FSH and LH checked~     and if sufficiently reduced will only then proceed to dosing.~      Subjects will then receive one of the formulations. An ultrasound scan of the ovaries will~     be performed 7 days later, and another one 7 days later just before the next dose. Subjects~     whose ovaries show signs of stimulation will not be given the second dose. The ultrasound~     scan will be repeated 7 days after the second dose.~   "
56488|NCT02317718|"~     Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20~     ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular~     disease, immune functioning, and glucose metabolism. Recent data from retrospective and~     prospective trials have demonstrated contradictive results concerning the role of vitamin D~     in female reproduction and IVF outcome. Some studies have found that women deficient in~     vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when~     compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated~     that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of~     advanced reproductive age. It may also have a role to play in endocrine dysfunction and~     abnormal folliculogenesis in polycystic ovaries .~      The aim of this prospective cohort study including infertile women undergoing IVF treatment~     is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian~     reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and~     miscarriage rates .~   "
56489|NCT02317705|"~     This study is being done to:~        -  test the safety of OTL38~        -  see if OTL38 helps light up the cancer when viewed with the special camera system~        -  test the safety of the special camera system for use along with OTL38 during surgery~   "
56490|NCT02317692|"~     The current pilot study aims to close the existing gap in our knowledge about effective~     psychosocial treatments for Latino families by providing preliminary data regarding the~     acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators~     that will support a future R01. Specifically, the current pilot study is the first step in a~     larger program of research aimed at definitively determining if culturally-modified ADHD~     treatment outperforms standard treatment when examining engagement and acceptability~     outcomes, as well as symptomatology and parental functioning, and if so, which treatment~     modifications are necessary and for whom. The following study aims will be examined.~        1. Aim 1 is to explore if the culturally-modified treatment results in better engagement~          and acceptability outcomes (i.e., parental attendance, retention, engagement, and~          satisfaction) than standard treatment and to determine the strength of these effects.~        2. Aim 2 is to explore if the culturally-modified treatment results in improvements in~          ADHD symptomatology, as well as parental functioning (i.e., parenting stress and~          efficacy), to explore if the modified treatment results in similar or greater~          improvements than standard treatment, and to determine the strength of these effects.~        3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and~          behavioral and cognitive acculturation) that may explain the relationship between~          treatment type (i.e., standard versus culturally-modified) and outcomes and to~          determine the strength of these interactions.~   "
56491|NCT02317679|"~     Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However,~     the outcomes are highly variable due to the new angiogenesis occurring after laser~     irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that~     occurred after treatment of port-wine stains by PDL. The main objective of this pilot~     clinical trial is to evaluate the effectiveness and safety of an inhibitor of endothelin~     orally taken, the Bosentan, following PDL treatment. Four patients with facial port-wine~     stain resistant to the PDL treatment will be included. The treatment by Bosentan (2 mg/kg~     twice daily, maximum 62,5 mg twice daily) will be given one day before the PDL irradiation~     and continued for 14 days. Only one test area of PWS will be treated with PDL. The primary~     outcome measure will be an important or complete improvement (Investigator Global Assessment~     3 or 4) between treated area and non treated one, 14 days after the end of the treatment~     which corresponds to one month after the laser PDL session. The evaluation will been~     performed on standardized pictures by 2 independent physicians blinded to the region treated~     or not.~   "
56492|NCT02317666|"~     Older people often use medications with anticholinergic or sedative side effects which~     increase the risk of falling, fractures caused by falls and cognitive impairment. In the~     Netherlands, medication reviews are done by pharmacists in collaboration with the general~     practitioner to optimize medication use and reduce these adverse drug events. To maximize~     the benefits of medication reviews it is helpful to identify patients with high risk~     medication, yet few appropriate tools are available The Drug Burden Index (DBI) designed in~     Australia, calculates anticholinergic and sedative drug burden. This study evaluates whether~     the DBI can be used to identify patients with anticholinergic and sedative medication in~     need of a medication review. A clustered randomized controlled intervention study will be~     conducted. Per pharmacy (cluster), one pharmacist will perform the medication reviews. In~     each pharmacy, one half of eligible patients will be randomly allocated to the control group~     and the other half in the intervention group. Data will be collected at baseline and at~     follow-up, 3 months after the medication review has taken place. The study population~     includes community-dwelling patients aged ≥ 65, with polypharmacy (≥ 5 medications) and a~     DBI value ≥ 1 (n = 190) selected by 10 community pharmacists. The intervention consists of a~     structured 5-step multidisciplinary medication review (STRIP method) as described in the~     multidisciplinary guidelines of Dutch General Practitioners performed by the pharmacist in~     collaboration with the general practitioner. The main endpoint is the difference in~     proportion of patients having a decrease of the DBI ≥ 0.5 between the intervention and~     control group at 3 months follow up. Secondary outcomes are anticholinergic side effects,~     risk of falls, cognitive function, function of daily activity, hospital admission and~     mortality. All participants will be informed about the study and asked to provide informed~     consent. Data will be processed confidentially. Only the researcher will have access to the~     data. If required, the Dutch Inspection of Healthcare will also be granted access to the~     data for Inspection. The burden of patients will be kept at a minimum by trying to retrieve~     as much information as possible from patient's medical records and by using questionnaires~     and tests that were specifically developed for this population. In the investigators~     opinion, participation does not involve risks.~   "
56493|NCT02317653|"~     The purpose of this study is to identify the influences of pregnancy on breast milk and the~     effects of these on the health of babies during the first 2 months of life. The~     investigators hypothesize that overweight and obese mothers will have lower serum n-3 to n-6~     PUFA ratios during pregnancy and postpartum than normal weight mothers and will be~     positively correlated with TNF-α, IL-1β, resistin, and negatively correlated ghrelin levels~     both in serum and in breast milk in postpartum.~   "
56494|NCT02317640|"~     The aim of this study is to understand what happens to muscle and bone in spinal cord~     injured males after four months of training using stand training, with body weight support~     (BWS), with testosterone replacement therapy (TRT), and electrical stimulation (ES).~     Specifically, researchers will investigate nerve, muscle, and bone changes in the lower~     limbs in response to stand training and ES when combined with TRT compared to i) standing~     alone with TRT; ii) stand training alone with placebo; iii) stand training alone and ES with~     placebo.~   "
56495|NCT02317627|"~     This study is being done to evaluate the safety, tolerability, activity, pharmacokinetics~     (PK), and daily dose regimen of KD025 administered orally for 12 weeks to subjects with~     psoriasis vulgaris who have failed at least one line of systemic therapy.~   "
56496|NCT02317614|"~     Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals~     infected with HIV, and can reduce the chance of HIV transmission, but a high degree of~     adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients~     in North America report ART adherence >90%. Thus, ART adherence interventions are a critical~     part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major~     factors in the transmission of HIV, and are associated with non-adherence to ART. Several~     types of interventions, most notably directly administered antiretroviral therapy (direct~     observation of antiretroviral administration and patient supports) and contingency~     management (the provision of incentives contingent upon objective evidence of adherence)~     have been effective in promoting ART adherence in drug users. However, a core problem with~     all ART adherence interventions is that their effects do not last after the interventions~     are discontinued. The common finding of post-intervention dissipation of effects suggests~     that ART adherence interventions may need to be long-term or even permanent adjuncts to ART~     for drug users. We intend to develop an intensive intervention that incorporates the most~     effective techniques for promoting ART adherence in drug users, and delivers them in a~     manner that allows for their large-scale implementation as long-term or even permanent~     adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions~     into a smartphone application that is easy for patients to use, simple to manage, and~     maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention~     that is highly effective and scalable. Toward that end, the SteadyRX intervention to be~     developed under this project will be largely automated and will (1) facilitate consultation~     with care providers (2) provide reminders when a dose is overdue, (3) provide electronic~     remote observation of medication-taking, and (4) reward ART adherence. In addition to~     developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+~     adults with a detectable viral load who use drugs or are in drug treatment. In this study,~     participants will be randomly assigned to receive usual care, or usual care plus the~     SteadyRX intervention.~   "
56497|NCT02317601|"~     The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to~     investigate the effect of single-high-dose glucocorticoid on surgical stress response and~     postoperative delirium among Elderly hip Fracture Patients undergoing surgery.~   "
56498|NCT02317588|"~     This study is single site, double-blind, randomized, cross-over study designed to compare~     the effects of flax oil and fish oil supplementation on the oxylipin profile in healthy~     males and females. Eligible participants will complete two (2) Supplementation Phases (flax~     oil versus fish oil) and will be asked to attend 6 in-person clinic visits (0, 1, 3, 7, 14~     and 28 days) for blood and urine collection during each phase. Participants will consume 8~     capsules a day for 28 days containing either A) Flax Oil at 4 grams of ALA per day ,in one~     phase and B) Fish Oil at a dose of 4 grams DHA + 0.8 grams EPA per day in the next phase.~     Participants will be randomized and blinded and will therefore no know what supplement they~     are taking in either phase.~   "
56499|NCT02317575|"~     This study evaluates four test formulations of a glucose lowering drug (LY900014)~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how the human body handles LY900014 and the effect of LY900014~     on blood sugar levels. Side effects and tolerability will be documented. The study will be~     conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study~     will last for about 11 to 12 weeks, including screening and follow up. Screening is required~     within 28 days prior to entering into either study Part A or Part B.~   "
56500|NCT02317562|"~     Primary objective:~      To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP~     response after an initial 6-month treatment in PRISM study. (I10E-1302).~      Secondary objective:~      To assess the safety of I10E in this patient population.~   "
56501|NCT02317549|"~     Septic shock is a potentially life-threatening condition that can result in multi-organ~     dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity~     during physiological shock and ameliorate the subsequent autodigestion leading to MODS and~     mortality. The purpose of this study in septic shock patients is to determine if enteral~     administration of LB1148 will increase the number of days alive without cardiovascular,~     pulmonary or renal replacement therapy through Day 28.~   "
56502|NCT02317536|"~     This study evaluates two L-Carnitine-based products on muscle function in healthy older~     adults (55 to 70 years old). These products are suspected to improve muscle function and~     possibly promote building of muscle mass. One third of the subjects will be on Carnipure~     Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.~   "
56503|NCT02317523|"~     This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and~     Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's~     caregivers. Half of participants will receive BA and the other half will receive support and~     information.~   "
56504|NCT02317510|"~     The aim of this study was to compare general anesthesia (GA) and combined (epidural and~     spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold~     standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer~     several advantages over general anesthesia.~      Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25~     patients). All patients has symptomatic gall stone disease or polyp of gall bladder.~     Intraoperative events related to combined anesthesia , postoperative complications, pain~     score and duration of operation time will record.~   "
56505|NCT02317497|"~     Background: Sedation of the intensive care unit (ICU) patient is necessary to relieve the~     patient from pain, anxiety and agitation and to enable mechanical ventilation, diagnostic~     investigations and invasive procedures. While sedation policy has shifted from deep sedation~     to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the~     cerebrovascular ICU patient is unclear and controversial.~      Method: MOderate vs DEep Regime in NeuroIntensive care SEdation (MODERNISE) is a~     prospective, randomized, open, two-center trial. Patients with acute ischemic stroke,~     intracerebral hemorrhage or subarachnoid hemorrhage who need to be ventilated are eligible~     for enrollment. It is intended to enroll 50 patients per group (n=100). Patients are~     randomized within 72h from admission to either moderate sedation as defined by Richmond~     Agitation Sedation Scale (RASS) >= -3 or to deep sedation as defined by RASS < -3 for the~     next 72h, after which weaning from sedation is aimed for in a stepwise fashion in both~     groups. If reduction of sedation is not feasible, patients remain at their respective~     sedation level for another 12 hours, and sedation reduction is then tried again. Patients~     are multimodally monitored for systemic and cerebral parameters (the latter including~     bispectral index (BIS) monitoring). The primary endpoint is ICU length of stay (ICU-LOS);~     secondary endpoints are several pre-defined variables of the ICU course, feasibility of~     sedation levels without violation of pre-defined safety criteria, pre-defined complications,~     and short- and long-term functional outcome and mortality.~      Conclusion: The feasibility, safety and benefits of moderate as opposed to deep sedation~     even in the acute phase of severe cerebrovascular disease needs to be clarified in a~     prospective randomized study. Results from this study might change sedation regimes and help~     prevent unwanted effects of deep sedation in the brain-injured patient.~   "
56506|NCT02317484|"~     The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose~     Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II~     Diabetes under usual care. It is also to investigate and analyze the exploratory influential~     factor of ipragliflozin treatment on clinical efficacy and safety.~   "
56507|NCT02317471|"~     The purpose of this study is to evaluate the safety and effectiveness of autologous gp96~     treatment of gastric cancer.~   "
56509|NCT02317445|"~     Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and~     the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the~     significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and~     upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods:~     To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008~     to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital.~     Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2,~     the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the~     Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C~     urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other~     biochemical indicators. The investigators explored the correlations of Hp eradication~     therapy with MACE (including recurrent myocardial infarction, revascularization and death)~     and UGIB after 3 to 5 years of follow-up using survival analysis.~   "
56510|NCT02317432|"~     The primary intervention offered through this study is a manualized and culturally adapted~     CBT intervention combined with an exercise intervention, administered by trained Community~     Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood~     symptoms and at risk of disability. In addition to the intervention implementation, the~     study examines how to successfully build collaborative research for the provision of~     evidence-based mental health and disability prevention treatments for ethnic minority elders~     in community-based settings. Thus, the study will evaluate the three components necessary~     for a successful intervention: efficacy, since the intervention must work, acceptability~     among clients and partnering agencies, and feasibility and sustainability within the~     organization.~   "
56511|NCT02317419|"~     This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study~     will establish the safety and tolerability profile of RO6927005 and will be conducted in two~     parts.~      In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single~     patient cohorts will be used to investigate increasing doses until a first dose-limiting~     toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related~     reactions), whichever comes first. At least 3 patients will be enrolled in each cohort~     thereafter, which, if required, can be expanded with additional patients. Part B of the~     study will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3~     patients) followed by an extension phase of RO6927005 given in combination with~     gemcitabine/nab-paclitaxel.~      Preliminary clinical activity will be explored throughout the study. Patients will be~     treated until disease progression and/or lack of clinical benefit, unacceptable toxicities,~     withdrawal from treatment for other reasons, death, pregnancy or termination of the study by~     the Sponsor, whichever comes first.~   "
56512|NCT02317406|"~     The purpose of this study is to evaluate the effect of the probiotic product on the GI tract~     flora composition.~   "
56513|NCT02317393|"~     The purpose of this study is to evaluate the contribution of the imaging to the expression~     of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at~     the end of chemotherapy.~      The investigators hope that the results of this first stage of the clinical trial come to~     consolidate the preclinical results obtained by the investigators team to characterizing the~     interest and the strong contribution of the use of a tracer resting on the expression of~     αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a~     non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.~   "
56514|NCT02317380|"~     Background:~      - Researchers want to learn about people s beliefs and values. They also want to learn about~     how people respond to information about cancer risk. They have created two short studies.~     They have combined these studies for convenience.~      Objective:~      - To learn about people s beliefs and values, and about how people respond to information~     about cancer risk.~      Eligibility:~      - Adults age 40-70 who are overweight, have never had cancer, and have an opposite-sex close~     relationship with someone in that age group who is also overweight.~      Design:~        -  This study will take place online or in a laboratory.~        -  Participants will take part in two studies. One is Values Study. The other is Cancer~          Risk Information.~        -  In Values Study, some participants will choose the most important value from a list.~          They will write about why that value is important to them. Others will choose the least~          important value from a list. They will write about why that value may be important to~          someone else.~        -  In Cancer Risk Information, participants will read a health message about a cancer risk~          relevant to themselves or to a close other. Some will wear special glasses that track~          their eye movements as they read.~        -  Participants will then answer questions about their beliefs about cancer risk and their~          intentions to lose weight.~        -  Both studies will take 30 minutes.~   "
56515|NCT02317367|"~     Background:~      - People respond differently when asked about their values. They also respond differently~     when they learn about how their actions affect their lives and health. Researchers want to~     learn more about these differences. This can help them improve public health messages.~      Objective:~      - To see how people respond differently to questions about their values and to information~     about alcohol and breast cancer.~      Eligibility:~      - Women age 18 and older who drink 7 or more alcoholic drinks per week.~      Design:~        -  This study will take place online.~        -  Participants will be randomly assigned to a group that will complete a certain task.~        -  Researchers will ask participants to complete 2 small studies:~        -  Values Study. Some participants may write briefly about a value that is important to~          them or to someone they are close to. Some participants will complete a short~          questionnaire instead of the writing exercise.~        -  Alcohol and Breast Cancer Study. Participants will read a health message. This will be~          about the link between alcohol use and increased breast cancer risk. Participants will~          then answer questions about what they read and their beliefs about alcohol and breast~          cancer.~        -  Both studies should take about 30 minutes.~   "
56521|NCT02317289|"~     Freezing of gait (FOG) is a particular and troublesome symptom occurring in some~     Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to~     include other associated gait pattern changes, like festination.Our purpose is to develop a~     wearable assistant which would trigger the most appropriate cueing aid just before~     occurrence of the freezing episode.~   "
56516|NCT02317354|"~     Background:~      -X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more~     about how people with XLRS choose to take part in research studies. They hope to find ways~     to help other people make decisions about joining early phase trials~      Objective:~      -To learn more about how people think and feel about taking part in early phase research.~      Eligibility:~      -Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a~     Phase I/II ocular gene transfer clinical trial.~      Design:~        -  Participants will be screened for the XLRS gene transfer study. They will be~          interviewed:~        -  Eligible participants who join the study - before the gene transfer procedure, then 3~          months and 12 months after it.~        -  Eligible participants who do not join the study - after their screening visit and 3~          months and 12 months later.~      <TAB>- Participants who are screened but ineligible - after their screening visit.~      <TAB>- Participants who choose not to be screened - at the time they make the decision and 1~     year later.~        -  Interviews will ask for the participants thoughts about the clinical trial and why they~          chose to take part or not. The interviews will be recorded.~        -  On the day of interview 1, participants will fill out a survey about their mood and~          personality.~        -  On the days of interviews 2 and 3, participants will fill out a survey about their~          mood.~        -  Interviews may be done in person or by phone. Surveys can be done online or through the~          mail. Or they can be done in person at the NIH Clinical Center.~   "
56517|NCT02317341|"~     Background:~      - Fatigue is a common side effect of cancer and its treatment. No medications can treat this~     fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation~     therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a~     sedative with similar effects.~      Objectives:~      - To better understand fatigue in people who completed radiation therapy for cancer. To look~     at the effects of a dose of ketamine on fatigue.~      Eligibility:~      - Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH~     protocol 08-NR-0132.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will complete questionnaires about their fatigue and take a breath alcohol~          test.~        -  The study is divided into 2 phases:~        -  During the first phase I visit, participants will have blood taken. They will talk~          about their fatigue and other symptoms. They will take thinking and handgrip strength~          tests. Then they will get either ketamine or placebo (midazolam) through an intravenous~          line, placed by a needle guided by a thin plastic tube into an arm vein.~        -  Participants will have a follow-up phone call within 1 day.~        -  Participants will have phase I visits 3, 7, and 14 days after infusion. For the 3- and~          7-day visits, participants will take thinking and handgrip strength tests. They will~          complete questionnaires, talk about infusion side effects, and have blood taken. For~          the 14-day visit, they will talk about their fatigue and infusion side effects. They~          will start phase II that day.~        -  Phase II visits are the same as phase I, except that the 14-day visit is over the~          phone.~   "
56518|NCT02317328|"~     Background:~      - By the time diseases of the retina are detected, serious damage has often already been~     done. Researchers want to find better ways of viewing the retina. One way called adaptive~     optics may help detect problems earlier.~      Objectives:~      - To study if adaptive optics can help find better ways to diagnose, treat, and manage~     retinal diseases.~      Eligibility:~        -  People over age 12 with an eye disease.~        -  Healthy volunteers over age 12 with 20/20 vision or better.~      Design:~        -  Participants will be screened with medical history and eye exams. These may include~          dilating pupils and taking pictures of the eyes.~        -  Participants will have 1 or more study visits. They will have:~        -  Medical and eye history.~        -  Questions about their medications.~        -  Eye exam including pupil dilation.~        -  Adaptive optics imaging. After dilation, participants sit still while looking into an~          adaptive optics instrument. They look at specific places and images are taken of their~          retina.~        -  They may also have:~        -  More images.~        -  Perimetry. Participants look into a lens and press a button when they see a light.~        -  Color vision tests.~        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses.~          A small metal electrode will be put on their forehead. They will look at flashing~          lights and try not to blink.~   "
56519|NCT02317315|"~     Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major~     public health concern, reaching 12.9% in 2006, despite intense research to reverse this~     trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by~     ultrasound are two tests which are proven to have benefit in the identification of those at~     greatest risk for preterm delivery. However the benefit of these tests is limited to~     situations where a negative result can avoid unnecessary interventions. Currently, maternal~     fetal monitoring is limited, as it is difficult to see what is going on in the placenta~     (maternal-fetal interface) without invasive measures such as placental biopsy or~     amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive~     compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are~     associated with preterm labor and birth. We hypothesize that preterm labor will display an~     inflammatory profile, which consists of unique inflammatory biomarkers from different~     non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions,~     and IP-10 in saliva), that correlates with a high incidence of preterm birth.~   "
56520|NCT02317302|"~     In this study, 50 evaluable patients will undergo one FDG-PET study during their~     chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment~     clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax,~     FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and~     heterogeneity during treatment will aid in better understanding the role of these biological~     parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging,~     have evaluated changes in the cervical tumor volume during treatment. The investigators~     expect there will be variation in how cervical tumors shrink and change during~     chemoradiation and therefore we are going to use multiple measures in addition to tumor~     volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at~     diagnosis the patients who are at higher risk for persistent disease following~     chemoradiation would allow for future studies where these high risk patients could be~     specifically targeted with more aggressive therapy.~   "
56524|NCT02317250|"~     A substantial portion of people covered by Medicare will develop Alzheimer's disease and~     other forms of dementia that together devastate the lives of millions of people in the~     United States, and cost us a total of over $200 billion every year. Getting a brain scan~     with a PET scanner to look for abnormal brain metabolism patterns is recognized as~     reasonable and necessary for some patients with a recently established diagnosis of~     dementia (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but~     the evidence is considered less clear for patients having less severe cognitive problems,~     and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in~     the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous~     design (prospective, multi-centered, randomized controlled trial) to determine whether such~     PET scanning can help distinguish more accurately than is being done in current clinical~     practice those patients with early molecular changes in their brains who will benefit from~     Alzheimer related treatments from those patients who will not, as proven by measuring to~     what extent the PET scans actually lead to earlier appropriate therapy, and in fact result~     in improved outcomes for Medicare beneficiaries and for the health care system in which they~     obtain care.~   "
56525|NCT02317237|"~     Patients suffering a stroke with a large vessel occlusion is often treated intra veneous~     thrombolyse and on top of that also intra arterial therapy. It is unknown what form of~     anaestesia is best during intra arterial therapy. The investigators will randomize these~     patients between general anaestesia and local anaestesia. Outcome will be growth of the~     ischemic lesion as judged on an MRI scan.~   "
56526|NCT02317224|"~     Surgery plays an important role in the treatment of anterior mediastinum disease. The major~     surgical approaches include: cervical approach, mid-sternal approach, cervical combined~     mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is~     rarely adopted because of its restricted visual field. The cervical combined mid-sternal~     approach have a broader field of vision, given this advantage, the surgeon can remove the~     thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is~     much larger, and the postoperative complication is also a serious problem. The~     video-assisted thoracoscope is often adopted by left or right approach, this minimally~     invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice,~     the investigators designed a new method named 3-Hole subxiphoid approach. This study is~     designed to compare the safety and validity between this new method and others.~   "
56527|NCT02317211|"~     Anthocyanins, the water-soluble compounds that make plants appear different colors, have~     been shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in~     rodents. The purpose of our study is to evaluate a potential protective effect of purified~     anthocyanins supplement on type 2 diabetes mellitus patients.~   "
56528|NCT02317198|"~     A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and~     older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized~     to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will~     be followed for one year for outcomes such as bleeding episode requiring medical~     intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction,~     non-fatal stroke, PLATO major and minor bleeding).~   "
56529|NCT02317185|"~     The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone~     graft substitute in comparison to autograft, which is considered the gold standard for~     posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT~     scans geneX® ds has been cleared by the FDA for use in these procedures; however this study~     will allow more detailed characterization of geneX® ds performance in the long-term (1~     year). By using the patient as their own control, direct comparison to autograft can be~     performed while minimizing other variables.~   "
56530|NCT02317172|"~     Elderly people usually have systemic diseases and take medications that can cause dry mouth.~     The purpose of this study is to determine whether continuous use of edible, gel-based~     artificial saliva in geriatric population with dry mouth problems will reduce signs and~     symptoms of dry mouth and improve quality of patients' saliva.~   "
56531|NCT02317159|"~     This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in~     patients with chronic phase of Chronic Myeloid Leukemia.~   "
56532|NCT02317146|"~     There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies~     demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take~     into account the use of magnesium sulphate before delivery. Termination of pregnancy is the~     best option to prevent eclampsia and magnesium sulphate has proven effective, but do not~     know the minimum effective dose.The investigators believe that if the patient has received~     less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium~     sulfate for 6 hours is as effective as keeping it for 24 hours.~   "
56533|NCT02317133|"~     The primary objective of this study is to search for evidence of quantitative or functional~     defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein~     Purpura (HSP) as compared to a control population.~   "
56534|NCT02317120|"~     Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with~     breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by~     specific criteria for high-risk status including age at disease onset.~      Secondary objective Considering the fact that BRCA testing is not a routine procedure in~     Romania and mutation prevalence varies in different populations, we intend to look for the~     founder mutation in our population, running full BRCA genes sequencing to a representative~     population sample. This would allow a more targeted approach to real-life practice and would~     ensure personalized solutions for every patient in need.~   "
56560|NCT02316769|"~     In this study, the investigators compare the effectiveness of two relatively new video~     laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems,~     Noblesville, IN), by practitioners experienced in airway management but with limited~     exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require~     fewer intubation attempts and shorter intubation times than the King Vision when performed~     by novice users.~   "
56561|NCT02316756|"~     This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine~     the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending~     doses of PF-06648671 in healthy subjects.~   "
56535|NCT02317107|"~     Previous research and position statements have outlined the necessity of balance and gait~     testing in the post-concussion evaluation of athletes. However, many of the currently~     available balance testing techniques lack objectivity and sensitivity to the effects of~     concussion. Such balance impairments may exist following concussion due to disruption of~     vestibular and/or ocular motor systems. However, no clinically feasible tools have been~     longitudinally examined to detect gait balance control deficits or to investigate how~     vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in~     physical and cognitive activities post-concussion may affect recovery. While limited~     evidence exists to support this notion, further investigation is necessary to improve~     clinical management recommendations.~      The proposed study will allow for the examination of tools which add value to~     post-concussion clinical evaluations and study-related outcomes will enhance the~     understanding of dynamic balance control and vestibular/ocular motor recovery, and their~     potential for implementation into concussion management protocols.~   "
56536|NCT02317094|"~     This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol~     on patient reported physical function, in patients with sporadic inclusion body myositis.~     The study is designed as a parallel group randomized controlled trial with a treatment group~     and a control group.~   "
56537|NCT02317081|"~     Prospective, multicenter, single arm study, to assess the feasibility and safety of the~     Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native~     vessels.~   "
56538|NCT02317068|"~     This study aims to determine whether increasing atrial base rate pacing to achieve at least~     75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of~     dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6~     months follow-up duration.~   "
56539|NCT02317055|"~     The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic~     resonance imaging on subjects and to correlate the results with near infrared spectroscopy~     measurements.~   "
56540|NCT02317029|"~     Background:~      Cardiac arrhythmias can be terminated by electrical current applied by an external~     defibrillator. This treatment, named cardioversion, has been used for decades in the~     treatment of atrial fibrillation.~      Several kinds of defibrillators exist, though the relative efficacy and safety of these~     defibrillators is not clear.~      During cardioversion, oxygen is being administered, and it has been a long-held belief that~     oxygen is always beneficial for the patient. This is now being challenged by recent studies~     suggesting excessive oxygenation to be potentially dangerous for the patients.~      Objective:~        1. To compare the efficiency and safety of two different defibrillators~        2. To investigate the effects of excessive oxygen on injury of the heart following~          cardioversion.~      Experimental design:~      Patients will be recruited at the outpatient clinic at the Department of Cardiology,~     Regional Hospital of Randers, Denmark as a part of the pre-cardioversion check.~      Patients will be randomized to cardioversion using one of two defibrillators and randomized~     to treatment with room air or 100% oxygen.~      The cardiac condition will be measured by blood samples before cardioversion, 4 hours after~     cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before~     cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.~   "
56541|NCT02317016|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung~     cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine~     kinase inhibitor (TKI) agent.~      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of~     rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients from Part A who completed~     treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease~     progression; they are no longer deriving clinical benefit; or any other reason.~   "
56542|NCT02317003|"~     This study evaluates the efficacy, in terms of energy expenditure, physical activity level,~     quality of life, blood pressure, waist circumference and weight, of a general practice based~     intervention involving a personalised physical exercise medical prescription, the structured~     delivery of information on the benefits of physical activity, a pedometer, and a pedometer~     log book, in 35 to 74 year old patients with cardiovascular risks factors.~   "
56543|NCT02316990|"~     Stress ulcers or stress-related mucosal disease (SRMD) is defined as acute superficial~     inflammation lesions of the gastric mucosa induced when an individual is subject to~     abnormally elevated physiologic demands.[1] Studies have shown that SRMD occurred in~     75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication~     in critically ill patients. The frequency of clinically important bleeding ranged from 5.3%~     to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which~     is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of~     Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis~     in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely~     used in China current clinical practice for the prevention of stress ulcer bleeding.~     However, there is no epidemiology data to show the risk factors for stress ulcer bleeding~     and the bleeding rate of Chinese neurosurgical critically ill patients who are usually~     suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is~     needed to know about the characteristics in Chinese critically ill neurosurgical patients.~      Objectives of this Non-Interventional Study Primary~        1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI)~          bleeding in critically ill neurosurgical patients in China.~        2. Main secondary objective~             -  To estimate the incidence of upper GI bleeding with clinically significant~               complications in critically ill neurosurgical patients in China.~             -  To estimate the incidence of any overt upper GI bleeding without clinically~               significant complications in critically ill neurosurgical patients in China.~             -  To assess time to upper GI bleeding after a cerebral lesion.~             -  To investigate potential risk factors associated with upper GI bleeding, and~               assess how common certain risk factors occurred in upper GI bleeding patients.~             -  To assess the overall incidence of upper GI bleeding in critically ill patients by~               different risk factors for upper GI bleeding.~             -  To investigate the drugs, the route of administration, the doses and the duration~               commonly used for stress ulcer prophylaxis.~             -  To investigate the proportion of ICU patients with nasogastric tube, and the~               duration of nasogastric tube.~      (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)~   "
56562|NCT02316743|"~     The purpose of this study is to determine whether levothyroxine supplementation is~     beneficial in patients with systolic heart failure and subclinical hypothyroidism on the~     functional class evaluated with a 6 minute walk test.~   "
56563|NCT02316730|"~     24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric~     coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized,~     crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1~     as detection indicators. Establish the blood drug concentration-time  curve, compare the~     bioequivalence of the main effective ingredients of the two preparations during the~     absorption process in human.~   "
56544|NCT02316977|"~     The aim of the study is to establish the intrarater-reliability, criterion validity and~     responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by~     patients diagnosed with rheumatoid arthritis.~      The study is designed as a repeated test-retest study including 240 patients filling in the~     ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a~     home-module in the DANBIO database) which makes it possible for the patients to complete~     their assessments and send information from their own home.~      Intrarater reliability will be assessed by calculating the intraclass correlation~     coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis~     and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be~     used to classify participants based on pain phenotype to explore any relationship between~     pain phenotype and reliability.~   "
56545|NCT02316964|"~     This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating~     patients with acute myeloid leukemia that has come back after previous treatment (relapsed)~     or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as~     decitabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving donor~     natural killer cells after decitabine may boost the patient's immune system by helping it~     see the remaining cancer cells as not belonging in the patient's body and causing it to~     destroy them (called graft-versus-tumor effect). Aldesleukin may stimulate natural killer~     cells to kill acute myeloid leukemia cells. Giving decitabine, donor natural killer cells,~     and aldesleukin may be a better treatment for acute myeloid leukemia.~   "
56546|NCT02316951|"~     This pilot study will seek to use emotion recognition technology from video to link patient~     facial expressions, heart rate and respiratory rate changes, and movement patterns to~     patient pain scores.~   "
56547|NCT02316938|"~     CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year,~     randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus~     and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.~     Patients in this study may use cyclosporine or tacrolimus as the CNI.~   "
56548|NCT02316925|"~     A randomized, double blind placebo-controlled parallel intervention in adults over the age~     of 50 will be performed. Participants will receive a supplement capsule containing placebo~     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is~     hypothesized to replenish the body's reserves that may be depleted through natural aging~     process, poor diet, or due to the detoxification process for drugs. The primary end point is~     the number of healthy days experienced during cold and flu season. Secondary endpoints~     include cellular and biochemical measures from blood samples taken before and after the~     study.~   "
56549|NCT02316912|"~     First in man evaluation of single and multiple doses of compound ATX2417 in healthy male~     volunteers. A double blind placebo controlled parallel group ascending dose design; up to~     five dose levels for the single dose and up to two dose levels for the multiple dose (8 days~     of dosing). Subjects will be screened to assure normal health prior to inclusion in the~     trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and~     pharmacokinetic profile. A fasted/fed comparison will also be included in the single~     ascending dose part of the trial.~   "
56550|NCT02316899|"~     The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients~     with constipation predominant irritable bowel syndrome (IBS-C).~   "
56551|NCT02316886|"~     The purpose of this study is to determine whether Bioresorbable Vascular Scaffold(BVS)~     implantation on functionally insignificant coronary stenosis with vulnerable plaque reduce~     the incidence of the composite of cardiovascular death, nonfatal myocardial infarction, or~     unplanned rehospitalization due to unstable angina compared with optimal medical therapy~     alone.~   "
56552|NCT02316873|"~     The purpose of this study is to determine whether music training is an effective treatment~     of reading disorders~   "
56553|NCT02316860|"~     In the present study the investigators evaluate the sensitivity and specificity of passive~     tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system~     activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for~     the improvement of diagnostic yield of tilt test in athletes.~   "
56554|NCT02316847|"~     This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray~     in adolescents and adults with cluster seizures, with a focus on potential local effects~     (changes in nasal mucosa, olfaction, and taste).~   "
56555|NCT02316834|"~     The goal of this clinical research study is to learn about the effects of BMN 673 on~     ovarian, Fallopian tube, and peritoneal cancer. Researchers want to find out if certain~     characteristics of the DNA (the genetic material in cells) affect how the disease responds~     to therapy with BMN 673 and if treatment with BMN 673 affects the genetic material in cancer~     cells.~   "
56556|NCT02316821|"~     The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney~     disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when~     this compound is administered once daily for 16 weeks in an intrapatient dose escalation~     design.~   "
56557|NCT02316808|"~     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.~     LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well~     known.~   "
56558|NCT02316795|"~     The NIR light source of our device is based on light-emitting diodes (LEDs), which can~     deliver sufficient light to biological tissues and induce fluorescence emission to meet the~     needs of the planned clinical studies. It should be noted that the light source is still~     well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the~     light source is not laser-based, which is significantly safer than other optical imaging~     systems utilizing laser technologies. The fluorescence signals will be received by the~     detector portion of our device. Gain-settings could be easily adjusted during operation to~     optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas~     (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as~     well as on a secondary monitor to facilitate viewing by other surgeons in the room.~   "
56564|NCT02316717|"~     This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E~     in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.~   "
56566|NCT02316691|"~     Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops~     in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially,~     the relapse rate is high and about 75% require further surgery despite initial response.~     Although the natural history of TED is associated with spontaneous remissions after about 1~     to 3 years, many irreversible serious ophthalmic and orbital complications can arise during~     this time. Therefore, there is a need for improved intervention strategies in the early~     active inflammatory phase of TED, to avoid progression to the cicatricial stage where~     disease manifestations can only be addressed in a rehabilitative fashion. The primary~     immunopathogenesis of Graves' disease is considered to be activation of B cells that then~     produce autoantibody against thyrotropin receptors in the thyroid (TRAb). Like in many~     autoimmune diseases, the inflammatory CD4+ T cell subset known as Th17 cells is also~     increased in blood of patients with active Graves' disease; the putative Th17 cytokine,~     IL-17, is also increased in serum and tears of TED patients. There is also an emerging~     pathogenic role for Th17 cells that co-express the chemokine receptor CXCR5 and drive~     autoantibody production. The contribution of Th17 cells to TED is not well defined. This~     study is an observational, longitudinal, prospective study of patients receiving treatment~     for thyroid eye disease.~   "
56567|NCT02316678|"~     The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis~     factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious~     infections, and reduced short term mortality risks, and therefore has a more favorable~     benefit to harm profile than corticosteroids for inflammatory bowel disease.~   "
56568|NCT02316665|"~     Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal~     glycemia in patients having type 1 diabetes and sleep apnea syndrome.~      Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in~     type 1 diabetic patients and that continuous positive airway pressure treatment will permit~     to improve the nocturnal glycemic profile.~      Study design: Adult patients with type 1 diabetes will be recruited for an extensive study~     of sleep habits and assessment of sleep breathing disorders. When patients will present with~     severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient~     glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway~     pressure treatment or sham-continuous positive airway pressure treatment group for three~     months.~      Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three~     months of the allocated treatment.~   "
56569|NCT02316652|"~     The purpose of this study is to determine whether the adjunctive use of chemical pocket~     disinfection with scaling and root planing is more effective than scaling and root planing~     alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing~     (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical~     pocket disinfection with scaling and root planing will have an effect on biomarkers of~     inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to~     scaling and root planing alone. The chemical pocket disinfection therapy consists of~     delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to~     the test site.~   "
56570|NCT02316639|"~     Recently, there has been a dramatic rise in the number of children participating in~     competitive sports. Adolescents involved in sports that require cutting, pivoting or body~     contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of~     the knee, however, appropriate management remains controversial. The surgical technique is~     commonly performed in the adult population has been associated with risks for growth~     disturbance when performed on skeletally immature individuals. Therefore, the recommended~     standard of care in children is to initially follow a non-surgical management protocol that~     allows a patient to skeletally mature prior to ultimately receiving surgical reconstruction.~     Unfortunately, current non-surgical management protocols are ineffective at enhancing knee~     joint stability and dynamic function. There has been no research to indicate the most~     appropriate exercise program for the ACL deficient skeletally immature individual. A~     neuromuscular exercise program proven to be safe and effective in the ACL deficient adult~     population is perturbation training. In adolescents, research suggests neuromuscular~     exercises can reduce the rate of ACL injuries by 50%. However, currently there is no~     research investigating the benefits of a neuromuscular exercise on the management of a~     skeletally immature ACL-deficient individual. The results of this investigation will provide~     researchers and clinicians valuable information on the effect of neuromuscular perturbation~     exercises on knee joint stability and function immediately following injury. This has the~     potential to minimize the development of secondary meniscal tears and premature joint~     degeneration commonly demonstrated following an ACL injury.~   "
56571|NCT02316626|"~     It is well known that implantation of the developing blastocyst occurs during the luteal~     phase of the menstrual cycle when the endometrium is under the direct influence of~     Progesterone (P).Several prospective randomized controlled trials have evaluated the~     benefits of luteal phase P support in ovulation induction cycles and a recent review and~     meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation~     induction with gonadotropins in intrauterine insemination (IUI) cycles. Until now,~     injectable P was offered only in an oil-base solution owing to the insoluble properties of~     the molecule, which made the IM route mandatory. A recent publication, however, demonstrated~     the efficacy of a new P formulation that could be a game changer. The aim of the present~     pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new SC P with~     90 mg/d of vaginal gel P for luteal phase support (LPS) in COH and IUI cycles.~   "
56572|NCT02316613|"~     This French national, multicenter, prospective, longitudinal, observational study will~     describe the treatment modalities of a cohort of patients with relapsed or refractory~     follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to~     the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating~     physicians will enroll patients and collect therapeutic management data in a real-life~     setting up to 5 years.~   "
56587|NCT02316418|"~     The aim of the study is to provide evidence of safety and preliminary performance of the~     Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female~     pattern hair loss; (FPHL)).~      The study will also help to determine whether the Hairstetics™ anchoring system, in~     conjunction with attachment of hair extensions, is efficacious in improving patient and~     physician aesthetic satisfaction with the treated scalp appearance in female patients with~     androgenetic alopecia.~   "
56573|NCT02316600|"~     The investigators aim is to evaluate an instrument for supporting physical activity and~     monitors multiple parameters of frailty (a pre-disability condition) in frail elderly~     persons. The investigators are therefore developing a smart shoe insole to monitor key~     parameters of frailty during subject daily life and to promote walking. Our primary aim is~     to assess the acceptability of the solution for the follow up and the motivational coaching~     of frail patients at home. Results from this study will also be used to elaborate the design~     of a further larger national multicenter randomized control trial assessing the efficacy of~     the solution to prevent disability.~   "
56574|NCT02316587|"~     This observational cohort study studies the impact myocardial fibrosis has on patients with~     severe aortic stenosis undergoing aortic valve replacement.~   "
56575|NCT02316574|"~     Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based~     psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural~     mechanisms through which CBCST changes drinking behavior, it may be possible to improve its~     efficacy. CBCST promotes abstinence by teaching coping skills for managing alcohol-related~     thoughts and emotions. In this pilot study, the investigators examine the neural systems~     that play a role in the learning of coping skills through CBCST, specifically focusing on~     the role of emotion regulation systems.~   "
56576|NCT02316561|"~     The purpose of the study is to investigate the feasibility of a preoperative, single dose,~     ablative partial breast radiation treatment in patients with early-stage breast cancer.~   "
56577|NCT02316548|"~     This randomized phase II trial studies the side effects and how well postoperative intensity~     modulated radiotherapy works after surgery in treating patients with urothelial bladder~     cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the~     pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more~     effective than surgery alone in treating patients with urothelial bladder cancer.~   "
56578|NCT02316535|"~     Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years~     old. However, compared with younger patients, elderly patients were often undertreated in~     chemotherapy due to their impaired tolerance. Recently, there have been great controversy on~     adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine,~     capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage~     III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was~     regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage~     II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively~     randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of~     age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or~     a reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary~     endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall~     survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this~     trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy~     strategy for stage II/III elderly CRC patients.~   "
56579|NCT02316522|"~     The main objective is to study the epigenetic contribution to the pathophysiology of~     diabetic nephropathy in Qatari population.~   "
56580|NCT02316509|"~     This is an open-label, dose-finding study of SRN-927 administered orally on a continuous~     daily dosing regimen with a PK lead-in period (dose escalation period only). The incidence~     of dose limiting toxicity (DLT) will be evaluated from Day -7 through the first cycle (28~     days) of treatment (35 days total). Depending on safety and tolerability, patients will be~     assigned sequentially to escalating doses of SRN-927 using standard 3+3 design. All patients~     will be treated until disease progression, unacceptable toxicity, or patient withdrawal of~     consent.~   "
56581|NCT02316496|"~     The main objective of this study is to evaluate the objective response rate at two months~     (complete disappearance of the disease and partial disappearance of the disease) obtained~     after administration of combination therapy with cetuximab and irinotecan in the patients~     with metastatic colorectal cancer.~      Secondaries objectives will be assessed progression-free survival, overall survival,~     toxicity, quality of life.~   "
56582|NCT02316483|"~     To assess the hypothesis that Charcot foot is associated with more vascular complications~     compared to matched diabetic patients without Charcot foot and to classify patients with~     Charcot foot according to the human genetic classification of the Qatari population.~   "
56583|NCT02316470|"~     Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4~     parallel study groups.~      500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be~     randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200~     µg w/o Alum, VLA84 200 µg w/ (with) Alum (150 subjects each), or placebo (50 subjects), as~     i.m. (intramuscular) vaccinations into alternating arms, on Days 0, 7 and 28~   "
56584|NCT02316457|"~     The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for~     Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and~     immunogenic RNA vaccines for a given patient's tumour. The TNBC-MERIT trial uses two~     complementary strategies, the IVAC® WAREHOUSE and the IVAC® MUTANOME concept, resulting in~     two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and~     IVAC_M_uID) for each individual patient.~   "
56585|NCT02316444|"~     The aim of this study is to compare the effectiveness of two vaccination strategies against~     Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus~     (HIV).~      Researchers plan to determine the optimal vaccination strategy for achieving protective~     immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care~     clinic.~      Primary objectives are to assess:~        1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.~        2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.~      The secondary objective is to evaluate whether lack of HAART is associated with high rates~     of loss to follow-up.~   "
56586|NCT02316431|"~     Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary~     tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow~     scenarios will be evaluated to create imaging protocols which are time efficient and~     diagnostically accurate.~   "
56588|NCT02316405|"~     It has been found that arm and leg cycling is similar to walking. Thus, the objective of~     this research is to determine if arm and leg cycling can be used to improve walking ability~     in a post-stroke population. This outcome would directly impact the health and quality of~     life for those who have suffered a stroke.~   "
56589|NCT02316392|"~     This study is a prospective, non-randomized, longitudinal, observational study that will~     recruit about 5 lung transplant patients per year for 3 years.~   "
56590|NCT02316379|"~     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon)~     gas MRI for regional assessment of lung function in a normal population of adults for the~     purposes of obtaining optimal images through MRI.~   "
56591|NCT02316366|"~     The purpose of this study is to determine if warming the intravenous (IV) fluid given to~     patients with Sickle Cell Disease who are experiencing painful episodes known as~     Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV~     pain medications given, improve pain and improve global comfort.~   "
56592|NCT02316353|"~     The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in~     preventing hereditary angioedema (HAE) attacks when it is administered under the skin of~     subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks.~     The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the~     treatment phase, wherein subjects will be randomized to treatment with either low- or~     medium-volume C1-INH. Subjects who have an insufficient treatment response during the study~     will be given an opportunity to undergo a dose increase. The study aims to enroll eligible~     subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in~     study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the~     United States (US) who complete Treatment Period 2 will be allowed to participate in an~     Extension Period. During the Extension Period participating US subjects will continue to~     receive treatment with open-label CSL830 for up to an additional 88 weeks.~   "
56593|NCT02316340|"~     This will be a randomized phase II clinical trial of patients with histologic documentation~     of metastatic colorectal cancer, who have received local and currently approved standard~     therapies, excluding RGF.~   "
56594|NCT02316327|"~     RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing~     pre & post treatment tumour volume by means of studying changes in the diameter of the~     selected target lesions by RECIST. The introduction of new targeted drugs creates the need~     of a different response assessment. Functional imaging techniques are able to study in vivo~     physiological processes of angiogenesis. Therefore, dynamic techniques may be more~     appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is~     focused on tumor's vasculature normalization. Preliminary studies have demonstrated~     significant and very early changes in indirect vasculature parameters such as flow, blood~     volume and tumor perfusion with vascular-targeting agents. These techniques may be useful~     for selecting patients who are going to benefit from antiangiogenic therapy by an early~     evaluation of response by means of functional imaging method.~      PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive~     value and early radiologic response or perfusion computed tomography (CT) in patients~     diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated~     with bevacizumab in combination with chemotherapy.~   "
56595|NCT02316314|"~     Friedreich's ataxia (FRDA) is an autosomal recessive disease characterized by loss of~     coordination and cardiomyopathy. It is the most common form of inherited ataxia with an~     incidence in 1/50,000 in the Caucasian population. FRDA is associated with progressive~     damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech~     problems, as well as diabetes and heart disease. The heart disease manifests as~     cardiomyopathy, and is responsible for approximately 60% of deaths from FRDA. This study is~     designed to characterize the cardiac manifestations of the disease using exercise, MRI, ECHO~     and serum parameters, in the context of the neurological disease.~   "
56596|NCT02316301|"~     The aim of this study was to determine whether misoprostol administered 12 hours before~     office hysteroscopy can relieve pain more effectively compared with misoprostol administered~     3 hours before office hysteroscopy.~   "
56597|NCT02316288|"~     Chronic pain is a costly public health problem that is associated with poor quality of life.~     Previous research has demonstrated extensive evidence showing that pain coping is not~     manifested by patients in isolation but within the context of significant relationships such~     as marriage. For instance, a partner may avoid or reject their partners' negative emotions~     about pain, provide unempathic responses to their partners' pain, or change their thoughts~     about pain. The patient's pain experience and the couples' relationship also have a cyclical~     relationship, in which both can affect each other and the overall quality of life for both~     partners. Currently, current clinical practice does not target both partners to alleviate~     pain. This is highly problematic given that a number of chronic pain patients—those with~     interpersonal distress—often do not complete, and thus, do not benefit fully from existing~     treatments. Even if treatment is completed, individuals may not maintain improvements if~     they return to distressed social environments that undermine individual coping efforts.~     Thus, it is clear that new interventions derived from integrative models of individual and~     dyadic coping are needed to alleviate pain and suffering in patients who are at risk for~     poor treatment outcomes. This research study aims to develop a novel psychological~     intervention aimed at couples in which one partner has chronic pain. Our central hypothesis~     is that a theoretically integrative intervention that improves both partners' psychological~     flexibility (i.e., acceptance, mindfulness, values-based action) and relational flexibility~     (i.e., emotional disclosure, empathic responding) skills will be feasible and valid and that~     it will alleviate pain and improve quality of life. This is a departure from current~     practice, which focuses solely on the patient's individual functioning, does not address the~     spouse's psychological inflexibility, and does not address relationship issues.~   "
56598|NCT02316275|"~     To determine the impact of unrestricted postoperative activity on intermediate- and~     long-term continence outcomes of mid-urethral sling surgery in women with stress urinary~     incontinence.~      To assess the natural return to baseline activity level when patients are unrestricted~     following mid-urethral sling surgery with or without concomitant anterior or posterior~     pelvic organ prolapse repair.~   "
56778|NCT02313922|"~     The purpose of this study is to evaluate whether etanercept combined with methotrexate are~     superiority than etanercept as monotherapy in the treatment of chinese severe plaque~     psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was~     conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by~     PASI (psoriasis area and severity index) response or PASI75 (a patient that has an~     improvement from baseline PASI of at least 75%)~   "
57229|NCT02308020|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as abemaciclib in participants with hormone receptor positive breast cancer, non-small~     cell lung cancer (NSCLC), or melanoma that has spread to the brain.~   "
56599|NCT02316262|"~     Subjects are being asked to participate in this study because they have an arm or leg~     amputation and have developed pain related to a neuroma (an ongoing localized pain related~     to a cut nerve ending).~      The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma~     pain and to have increased prosthetic control. This surgery connects these cut nerve endings~     to nerves going into nearby nonfunctional muscles. This surgery was developed to allow~     amputees to have better prosthesis control. By chance, neuroma pain improved significantly~     with TR. The investigators, therefore, are conducting this clinical trial. The investigators~     will ask all participants to fill out a questionnaire both before and after surgery. This~     will help us understand how a neuroma affects the quality of life of amputee will allow us~     to understand how to best improve neuroma pain and prosthesis control.~      In order to confirm the presence and location of the neuroma before surgery, a magnetic~     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie~     still for a short period of time but does not involve any invasive procedures.~   "
56600|NCT02316249|"~     To compare the use of Estrace ® vaginal cream against a placebo vaginal cream in reducing~     symptomatic vaginal discharge and vaginal erosion in patients who are using the Gellhorn or~     Ring with support pessaries.~   "
56601|NCT02316236|"~     The study is to observe whether dexmedetomidine could reduce agitation during emergence from~     general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.~   "
56602|NCT02316223|"~     A 3-arm, patient-randomized trial among Latino and African-American older adults with~     poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs.~     home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.~   "
56603|NCT02316210|"~     This study aims to facilitate further optimization of a neuromuscular electrical stimulation~     device for use in patients whom are suffering from oedema and neuropathy~   "
56604|NCT02316197|"~     MSC2490484A is an investigational drug that is being evaluated for the treatment of subjects~     with advanced solid tumors or chronic lymphocytic leukemia (CLL) that likely differs from~     other cancers in how it repairs damaged DNA (genetic material). This is a first-in-man Phase~     I study, which means that it is the first time the study drug is being used in humans. The~     main purpose is to determine the highest dose that does not cause unacceptable side effects.~     The second is to determine the appropriate dose to use in future research for subjects with~     cancer. Other goals of the study are to learn about the drug's safety and side effects, how~     it affects the tumor, and how the body processes the drug.~   "
56605|NCT02316184|"~     Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have~     been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to~     determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol~     reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected~     participants will receive BA delivered by their HIV PCP during a regular HIV visit and will~     then be randomized to either a 30-minute Motivational Interviewing Intervention with a~     Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting,~     drinking check-in (MI or BA) sessions will then be provided telephonically every three~     months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks~     per week.~   "
56606|NCT02316171|"~     The study will consist of 2 sequential parts. Part A is a study of the safety and~     tolerability of CAVATAK administered via intravesical instillation in patients with~     non-muscle invasive bladder cancer scheduled to undergo TUR. Part B will evaluate the safety~     and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C~     in the same patient population.~   "
56607|NCT02316158|"~     The overall aim with the project PsYoungSupport is to evaluate Internet and communication~     technology (ICT) health efforts, i.e. information, education and support for young adults~     (16-25 years) who are first degree relatives or represent the close social network (relative~     or close friend) of individuals with mental illness, with regard to the process (the quality~     and usefulness of the support) and the effect (on health and quality of life, situation as~     relative or part of close social network and consumption of other support/care) of the~     intervention.~      The participatory design is one of the foundations of this project, and young adult~     participants will be consulted through out the research project. PsYoungSupport is a~     research program comprising three phases, Phase I is a survey of young relatives' and close~     friends' needs for internet based information, education and support, Phase II is the~     development of a website, and Phase III is an intervention based on the previous phases. The~     aim of phase III is to evaluate the effect of an internet based intervention containing~     information, education and support for young adults in families where a family member~     suffers from mental illness or functional disability. The participants (N=400) will be~     randomised to two groups with different kinds of support. The participants will be evaluated~     using self-questionnaires and web interviews at the following occasions: baseline at the~     start of the intervention, after 4 months and after 8 months. This project will have~     implications for persons suffering from mental illness as well as for their relatives and~     close friends.~   "
56608|NCT02316145|"~     Purpose: To develop a model for internet-based support and coaching to young adults with~     neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and~     his/her understanding of how he/she is functioning.~      NPD comprise problems with social interaction, attention, impulse control and hyperactivity.~     The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism~     spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use~     Internet-based treatment for young adults with NPD.~      Method: Support/coaching by using communication over the Internet (chat and e-mail) with~     individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered~     support and coaching over the Internet by psychologist/educational therapist with great~     experience from NPD. The individuals are assessed before and after treatment pertaining to~     quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and~     parents' evaluation of the young adult's situation.~   "
56794|NCT02313714|"~     This study intends to treat patient with congestive heart failure that are maximized their~     pharmacological treatment and at heart transplant wait list.~      All patients in the treatment arm will receive electric muscular stimulation with a Russian~     current protocol twice a week for 7 weeks.~      The outcome will be assessed by the improvement in quality of life and functional capacity.~   "
56609|NCT02316132|"~     After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's~     esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is~     needed for CLE but is not part of the investigation.~      Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed~     baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal~     mucosa.~      Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according~     to randomisation) will be injected intravenously. Endoscopist and assistant staff will be~     blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5~     min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of~     fluorescein into the gut lumen and widening of intervillous space.~      Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and~     eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron~     microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent~     staining for mast cell tryptase to identify mast cell activation and numbers.~      The procedure will take around 15 minutes in addition to the routine investigation performed~     prior to the study. A study outline is presented in figure 1.~      Samples taken are the same amount as done in the previous food associated study.~   "
56610|NCT02316119|"~     Background: About 5% of patients with acute coronary syndrome (ACS) have had previously~     ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population,~     with a high incidence of ischemic events, and also of bleeding events. While the high~     ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk~     factors, their predisposition to bleeding events is not well understood. Hypothesis: The~     increased bleeding risk in ACS patients with history of cerebrovascular event may be~     justified by a low platelet activity. Methods: Unicentric, prospective, case-control study,~     which included approximately 100 post-ACS patients with history of IS/TIA previously to the~     acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The~     groups were matched for gender, age, and ACS type and year of occurrence. All patients were~     taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy,~     previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy.~     Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®,~     VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry~     with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL~     transport and inflammatory evaliation~   "
56611|NCT02316106|"~     The purpose of this study is to evaluate three daratumumab dose schedules in participants~     with Smoldering Multiple Myeloma.~   "
56612|NCT02316093|"~     Obesity may affect periodontal health by inducing gingival oxidative damage through~     increased production in circulating reactive oxygen species (ROS). Several studies have~     demonstrated that 8-OHdG in bodily fluids can act as a biomarker of oxidative DNA damage in~     periodontal diseases and for evaluating the effect of periodontal treatment. In the present~     study we hypothesized that high ROS levels in circulation may increase oxidative stress~     levels in the gingival crevicular fluid (GCF) and saliva in obese patients with periodontal~     disease, thus periodontal therapy could have positive effects on ROS levels.~   "
56613|NCT02316080|"~     The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching~     agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with~     desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with~     7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice~     (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type~     45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3;~     T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC.~     In the in vitro study, microhardness and roughness measurements, and images using scanning~     electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin~     (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14~     days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the~     clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin~     hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments~     (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the~     desensitizers/remineralizer agents (there´s no control group in the clinical experiments)~     will be applying. Data will be analysed intra and inter-group, statistically.~   "
56614|NCT02316067|"~     The purpose of this study was to evaluate the effects of an exercise program proposed by the~     CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle~     thickness of trunk muscles in patients with traumatic spinal cord injury.~      The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the~     traumatic spinal cord injury.~   "
56615|NCT02316054|"~     Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT~     over clinical and ischemia in high-risk diabetic patients~   "
56616|NCT02316041|"~     This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for~     refractive correction of hyperopia using the small incision lenticule extraction (ReLEx~     smile) method.~      In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive~     lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK~     flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed~     to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is~     dissected and removed through a small 2-3mm incision without the need to create a whole~     flap.~      The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize~     the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment~   "
56779|NCT02313909|"~     This is a study in patients who recently had a brain attack (stroke) and in whom no clear~     cause of the stroke could be identified. These strokes are likely due to a blood clot and~     therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS.~     The study will compare 2 blood thinners. Patients will be randomly assigned to either~     Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given~     rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.~   "
56780|NCT02313896|"~     This is a 2 year research study to study if post discharge phone calls can help lengthen~     time to hospital readmissions for patients with encephalopathy.~   "
56617|NCT02316028|"~     Despite the advances in the medical treatment of unresectable liver metastases from~     colorectal cancer there is currently no curative treatment option available for these~     patients. Decitabine is a cytidine analog with proven anti-neoplastic activity in patients~     with acute myeloid leukemia and myelodysplastic syndromes. Decitabine causes demethylation~     of the DNA strands of replicating cells. Hereby decitabine treatment demethylates the~     promoter regions of tumor suppressor- and cancer testis antigen encoding genes leading to~     expression of these genes by the cancer cells. The hepatic arterial route for administration~     of cytotoxic drugs has been widely explored in treatment of colorectal cancer liver~     metastases because these metastases depend for their blood flow from this artery (as opposed~     to the normal liver tissue that is mainly dependent from the portal vein). By investigating~     the administration of decitabine by hepatic arterial infusion the investigators intend to~     explore the potential advantage of minimizing the systemic exposure (and toxicity) and~     maximizing the concentration of decitabine within the liver metastasis. The primary~     objective of this phase I will be to establish the recommended dose for decitabine by HAI~     for further use in phase II trials. The most important secondary objective will be to~     document the effect of decitabine by HAI on the expression of cancer testis antigens by the~     colorectal cancer cells, serving as a reference for potential further exploration of~     decitabine by HAI in combination with cancer immunotherapy~   "
56618|NCT02316015|"~     The aim of this study is to investigate if a standardized nutritional intervention with a~     protein and energy enriched milk could help overcome the catabolic state in children~     hospitalized with a bronchiolitis and thus creating a better nutritional state during~     hospitalization and at outpatient follow-up.~      The investigators also want to assess the clinical repercussion on the number of~     hospitalization days, the duration of oxygen support and the quality of life at ouptatient~     follow-up.~   "
56619|NCT02316002|"~     The main purpose of this study is to see how well the experimental drug pembrolizumab~     (MK-3475) works in people with oligometastatic NSCLC who have already had treatment for~     their disease. All patients will receive 200 mg of pembrolizumab intravenously on Day 1 of~     each 21-day cycle. Patients will receive the study drug for up to 8 cycles, and then if~     their disease is doing well and the study doctor thinks they will benefit patients may~     receive pembrolizumab for up to 8 more cycles.~   "
56620|NCT02315989|"~     The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries'~     proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung~     Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on~     tumors, as well as to assess the operating functionality of the proton therapy system.~   "
56621|NCT02315976|"~     This is an open, self-paired study of 200 patients with heart failure who have a diagnosis~     of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate~     (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00~     PM. The study will include three visits the patient to the study center: Pretreatment /~     Assessment 1, Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of~     treatment. At each visit, data will be collected on the medical history, physical~     examination and vital signs, and evaluation of episodes of angina pectoris, as well as the~     laboratory evaluation of adverse events and the use of concomitant medications.~   "
56622|NCT02315963|"~     High motivation is a predictor for good therapy results in physical therapy [Grahn 2000].~     The investigator want to show that it is possible to increase patients motivation for stroke~     rehabilitation by providing them objective performance feedback about the patients therapy~     progress.~   "
56623|NCT02315950|"~     With the goal of providing improved treatment to patients with overactive bladder symptoms~     (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI~     combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum~     toxin on bladder physiology. The investigators will specifically aim to assess the~     physiological mechanism by which intravesical botulinum alleviates urgency and urge~     incontinence symptoms in women with OAB refractory to medical therapy.~   "
56624|NCT02315937|"~     Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side~     effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This~     hypotension is often treated with fluid infusion. However, especially in elderly patients,~     high volume fluid infusion can lead to fluid overload.~      The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known.~     Hence, therapy for hypotension after spinal anesthesia might not be adequate. With~     transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used~     to monitor fluid responsiveness and guide fluid management.~      Objective: This study has two main objectives. The first is to explore the effects of spinal~     anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter~     and collapsibility. The second goal is to test the interrater variability transthoracic~     echocardiography exams when performed by (trained) anesthesiologists.~      Furthermore, the correlation between vena cava inferior collapsibility and the occurence and~     degree of hypotension (defined as a decrease from baseline of >20% or a systolic pressure <~     90 mmHg) after spinal anesthesia will be explored.~   "
56625|NCT02315924|"~     Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and~     intracranial atherosclerosis patients have high rate of coronary artery disease (CAD).~     Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis,~     which had been proved to increase the risk of stroke after coronary revascularization~     including coronary bypass surgery or percutaneous coronary intervention. In addition, the~     efficacy and safety of combined coronary and cerebral intervention are not fully~     investigated. Hence, the aim of this study is to evaluate the prevalence and characteristics~     of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and~     cerebral angiography, explore the relationship between inflammation, atherosclerosis-related~     markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of~     simultaneous or staged coronary and cerebral interventional strategy in Chinese Patients.~      The coronary angiography and cerebrovascular angiography are performed for all participants.~     The combined strategy for coronary and cerebrovascular angiography is carried out routinely~     in the investigators institutions. Simultaneous strategy is considered as that performed via~     the same access and within the same day. Staged strategy is intended as that performed~     within 7 days from the first procedure. The sequence of angiographies is established on an~     individual patient basis by the cardiovascular and neurointerventional team according to~     clinical symptoms of the patients and after coronary or cerebrovascular angiography. After~     combined coronary and cerebral angiography, simultaneous or staged interventional strategy~     will be performed in patients with severe coronary and cerebral stenosis. Blood sample is~     obtained from artery sheath when performing coronary or cerebral angiography. Lipid levels,~     inflammation and atherosclerosis-related markers will be measured in this study.~   "
56626|NCT02315911|"~     Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA.~     Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either~     ATE or APP. Pediatric age span of 2 until 4,9 years.~   "
56627|NCT02315898|"~     Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the~     formation of obstructive airway casts primarily composed of fibrin. There is presently no~     FDA-approved pharmacotherapy for PB, but acute exacerbations of the illness are often~     treated with inhaled tissue plasminogen activator (tPA). To date, this is done somewhat~     anecdotally because there has been no safety or efficacy testing of this treatment. In~     addition, there is presently no reliable surrogate marker of adverse drug events.~     Nevertheless, in the absence of inhaled tPA treatment, PB-induced respiratory distress can~     be severe, often warranting urgent or emergent bronchoscopy for cast removal, or can~     sometimes result in respiratory failure. As such there is a significant unmet need for~     safety and efficacy testing of inhaled tPA and for biomarkers of drug response.~      Objectives and Endpoints: The objectives of this protocol are to: 1) test the safety and~     efficacy of an inhaled tPA regimen in children with PB; and 2) identify potential candidate~     biomarkers of inhaled tPA drug response. Safety endpoints will consist of the development of~     new, active bleeding that is systemic and/or pulmonary and/or new hematuria (defined as~     gross hematuria or 2+ microscopic hematuria). Secondary endpoints of efficacy will also be~     measured (e.g., frequency of cast production). Urine and blood will also be collected for~     the development of potential biomarkers of inhaled tPA drug response.~   "
56628|NCT02315885|"~     The purpose of the research study of the K23 award is to develop a blood test that can check~     how much alcohol a person has consumed in the past few days. We will enroll heavy social~     drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a~     single occasion. Both men and women between ages 21 and 65 years can join the study. All~     participants must be of European decent.~   "
56629|NCT02315872|"~     This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are~     experiencing chronic fatigue.~   "
56630|NCT02315859|"~     It is known that, at the end of the cardiac ejection period, potential energy is stored in~     elastic fibers of the heart, which promotes the suction of blood from the atria during early~     filling. The investigators have developed a new ultrasound-based method to quantify this~     suction effect. Here, it is necessary to reduce the complex 3-dimensional cardiac mechanics~     in a 1-dimensional (piston-like) pump system. In the study, several steps of model reduction~     will be tested. Each reduction is intended to allow non-invasive measurements to become~     increasingly simple and feasible at reduced echo quality. The reference method is the~     invasive data obtained from a pressure-volume conductance catheter. To increase the supply~     of potential energy in the elastic fibers, a substance (dobutamine) is administered for~     transient strengthening of the force of contraction.~      Hypothesis: There is a good agreement between the new, non-invasive parameters and the~     invasive reference method for the quantification of the suction effect of the left~     ventricle, and the good correlation persists even with increasing model simplification.~   "
56631|NCT02315846|"~     The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The~     investigators therefore score patients once preoperatively and twice postoperatively with~     the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and~     compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity~     and the serum anticholinergic activity (SAA) at corresponding time points.~   "
56632|NCT02315833|"~     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine~     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)~     the headache attacks in migraine patients.~   "
56633|NCT02315820|"~     The equipoise whether to Induce pregnant women with suspected large for gestational babies~     or suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small~     studies were conducted to answer this clinically important question.~      The investigators will conduct a randomized controlled, multi-center study large enough to~     confirm or refute our assumption that induction of labor at term reduces the shoulder~     dystocia prevalence significantly compared to expectant management.~   "
56634|NCT02315807|"~     Transcranial direct current stimulation has shown promising results in stroke patients. This~     study is a double blind, sham-controlled clinical trial aiming to compare the long-term~     effects of stimulation in two different cognitive regions after a stroke. Sixty patients who~     suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal~     cortex, cingulo-opercular network and motor primary cortex (control). Each group will~     receive transcranial direct current stimulation for 20 minutes for 10 consecutive working~     days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic~     Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence~     Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at~     baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who~     achieve clinical improvement with neurostimulation will be invited to receive treatment for~     12 months as part of a follow-up study.~   "
56635|NCT02315794|"~     Different studies have proposed the use of zirconia abutments to improve the aesthetic~     outcomes in the anterior sextant, however the results have been inconclusive. A tendency~     towards a better aesthetic result with the use of zirconia instead of titanium abutments was~     observed, although more technical complications were also recorded.The use of zirconia~     abutments in the anterior maxillary region showed a tendency towards better matching,~     although differences were not significant. In addition, with these abutments more technical~     complications were observed, what increased the cost and time. More studies with larger~     samples and longer observations periods are needed to recommend the use of zirconia~     abutments for this clinical situation~   "
56636|NCT02315781|"~     Parkinson's disease (PD) is a progressive neurological disease that has effects on both~     movement and mental health. One of the most common mental health complications of PD is~     depression. Up to 30% of Parkinson's patients will experience depression at some point. We~     aim to investigate whether transcranial direct current stimulation (tDCS), a type of~     electrical stimulation for the brain, can improve depression in PD as well as improve motor~     function in PD.~   "
56637|NCT02315768|"~     The purpose of the study is to determine whether ibrutinib in combination with GA101 -~     Obinutuzumab might be useful for the treatment of CLL. This study will evaluate if ibrutinib~     in combination with GA101 - Obinutuzumab can reduce the amount of cancerous cells in body.~   "
57230|NCT02308007|"~     The purpose of this study is to evaluate the safety and efficacy of~     terconazole/metronidazole gel in the treatment of vaginal infections~   "
56638|NCT02315755|"~     Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys.~     Targeted therapies, which were recently introduced in the treatment of mRCC, have become the~     standard treatment in these patients. With improved survival rate and a tolerable side~     effect profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional~     immunotherapies worldwide.~      In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the~     standard treatment as first-line therapy.~      Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI~     treatment does not reflect the QoL status of patients treated with TKIs as second or third~     line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of~     life of targeted treatments following TKIs will be explored. To our knowledge, since there~     is no similar reimbursement condition in the world placing IFN as the first line standard~     treatment, this will be the first study evaluating the QoL status with targeted therapies~     used as 3rd line treatment in mRCC patients.~   "
56639|NCT02315742|"~     The purpose of this study is to see if walking is effective for improving memory,~     concentration thinking abilities, physical function and quality of life of adults 50 years~     of age and older living with HIV.~   "
56640|NCT02315729|"~     The purpose of this study is to identify potential markers for curve progression in~     adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health,~     the etiology of AIS and molecular mechanisms underlying its development and progression~     remain poorly understood. Clinical criteria and features cannot adequately predict which~     children, diagnosed with mild disease, will undergo subsequent curve progression requiring~     intervention.~      The investigators hypothesize that alterations in specific genetic markers will be~     correlated with the progression of AIS curves over time. Thus, these markers could be used~     in the future to develop a reliable, inexpensive and relatively non-invasive cell based~     diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely~     to benefit from early surgical intervention, and (3) potentially screen for asymptomatic~     children at risk of developing idiopathic scoliosis.~   "
56641|NCT02315716|"~     The Cardamon trial is a phase 2 trial using the standard chemotherapy drugs cyclophosphamide~     and dexamethasone in combination with a new drug called Carfilzomib in patients with~     multiple myeloma.~   "
56642|NCT02315703|"~     The purpose of this study is to assess the safety and tolerability of various regimens~     containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV),~     Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug~     product (gp140 DP) components and to compare envelope binding antibody responses between the~     different vaccine regimens.~   "
56643|NCT02315690|"~     This is a cluster randomised controlled trial comparing the impact of two community based~     malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive~     treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.~   "
56644|NCT02315677|"~     The purpose of this study is to determine the degree of epistaxis following nasal intubation~     with either a nasal endotracheal (RAE) tube with bevel facing left or Parker Flex-Tip~     endotracheal tube with bevel facing posteriorly~      The investigators hypothesize that a Parker Flex-Tip endotracheal tube when inserted with~     bevel facing posteriorly during nasal intubation may reduce the incidence of epistaxis intra~     and post-operatively. The investigators propose that using this style of endotracheal tube~     improves patient safety and comfort and facilitates ease and success of nasal intubation.~   "
56645|NCT02315664|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of~     150 minutes or more per week. The primary goal of this randomized controlled trail is to~     assess the efficacy of a physical activity counseling model, involving a group education~     session, the use of Fitbit Flex (a wireless physical activity tracking device), and~     online/telephone coaching by a physiotherapist (PT), to improve physical activity and reduce~     sedentary time in patients with knee OA. Engaging in regular physical activity can have the~     additional benefit of improving cognitive functioning.~   "
56646|NCT02315651|"~     The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10~     (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded,~     placebo-controlled prospective study. All eligible patients will undergo randomization and~     divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power~     calculation, total of 60 subjects are expected to participate in the study. After the~     screening of eligibility (up to 14 days), the study is divided into three phases:~     pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of~     treatment, and post-treatment phase. Screening: each participant will undergo screening for~     protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the~     inclusion criteria and signed an approved informed consent (both parents and the child) will~     be enrolled.~   "
56647|NCT02315638|"~     This is a long-term safety follow-up protocol for subjects who received TT-034 under the~     B2801001 protocol and consists of monitoring for at least 4.5 years.~   "
56652|NCT02315573|"~     This study is focused on comparing patients' pain scores on a visual analogue scale (VAS)~     and the difference in analgesics use post-operatively (with the same prescription defining~     only the maximum frequency) between lidocaine with epinephrine & bupivacaine with~     epinephrine as local anesthetics in wide-awake hand surgery. The investigators' hypothesis~     states that a longer acting local anesthetic agent (bupivacaine) would be able to provide~     better postoperative pain relief demonstrated by lower pain scores on VAS and less~     analgesics use (as will be recorded on the patient's log). This will be mainly obvious in~     the first 24 hours postoperative period when the pain is usually at maximum levels and~     starts to decline thereafter. If the investigators' hypothesis is true, this may potentially~     change practices of many hand surgeons towards the routine use of longer acting local~     anesthetics particularly in wide-awake hand surgery, and perhaps could be extrapolated to~     other surgical specialties. Further, a reduction in postoperative analgesics use would be of~     paramount clinical importance, as it would reduce their potential side effects.~   "
56653|NCT02315560|"~     To determine the effects of electrical stimulation of the nerves in the foot on the~     incidence of nocturnal enuresis (bedwetting) in children~   "
57231|NCT02307994|"~     The purpose of this study is to determine whether uFSH is effective and safe in the~     treatment of male patients with severe oligospermia or azoospermia.~   "
56648|NCT02315625|"~     Background:~      - Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some~     people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think~     that treatment with drugs based on knowing the defective gene might give better results.~      Objective:~      - To see if drugs selected based on the defective gene result in better tumor response. The~     drugs are sunitinib and everolimus.~      Eligibility:~      - People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or~     pancreatic neuroendocrine tumor.~      Design:~      - Participants will be screened with:~      <TAB>- Medical history~      <TAB>- Physical exam~      <TAB>- Scans~      <TAB>- Blood, urine, and lab tests~        -  The study team will see if participants should have surgery.~        -  If yes, participants will:~        -  Sign a separate consent~        -  Have CT scan before and after surgery~        -  Have as much of the tumor removed as possible. A small piece will be tested for~          mutation type.~        -  If no, participants will have a small piece of tumor removed for the testing.~        -  If the surgery might cure them, the participant will leave the study. The other~          participants will be assigned to take either sunitinib or everolimus.~        -  Participants will take their drug by mouth once a day. They will keep a medicine diary.~          Some will keep track of their blood pressure at least weekly.~        -  Screening tests may be repeated at study visits. Participants also may have their heart~          evaluated.~        -  About 30 days after the last day of their study drug, participants will have a~          follow-up visit that repeats the screening tests.~        -  Participants will be contacted every 3 months after this visit.~   "
56649|NCT02315612|"~     Background:~      - One type of cancer therapy takes blood cells from a person, changes them in a lab, then~     gives the cells back to the person. In this study, researchers are using an anti-CD22 gene,~     a virus, and an immune receptor to change the cells.~      Objective:~      - To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with~     certain cancers is safe and effective.~      Eligibility:~      - People ages 1 30 with a leukemia or lymphoma that has not been cured by standard therapy.~      Design:~        -  Participants will be screened to ensure their cancer cells express the CD22 protein.~          They will also have medical history, physical exam, blood and urine tests, heart tests,~          scans, and x-rays. They may give spinal fluid or have bone marrow tests.~        -  Participants may have eye and neurologic exams.~        -  Participants will get a central venous catheter or a catheter in a large vein.~        -  Participants will have white blood cells removed. Blood is removed through a needle in~          an arm. White blood cells are removed. The rest of the blood is returned by needle in~          the other arm.~        -  The cells will be changed in a laboratory.~        -  Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the~          hospital for this.~        -  All participants will be in the hospital to get anti-CD22 CAR cells through IV. They~          will stay until any bad side effects are gone.~        -  Participants will have many blood tests. They may repeat some screening exams.~        -  Participants will have monthly visits for 2-3 months, then every 3-6 months. They may~          repeat some screening exams.~        -  Participants will have follow-up for 15 years.~   "
56650|NCT02315599|"~     Background:~      - Gene therapy involves changing the genes inside the body s cells to stop disease. It is~     very closely regulated. People who have had this therapy may have problems months or even~     years later. Researchers do not know the long-term side effects, so they want to study~     people who have had the therapy. They want the study to continue over the next 15 years.~      Objective:~      - To study over time the negative side effects from genetically engineered cellular therapy.~     This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy~     trials.~      Eligibility:~      - People who are currently or were previously in a research study with gene therapy in the~     National Cancer Institute POB.~      Design:~        -  Participants blood will be tested right before they get the genetically changed cells.~          They will get the cells as part of another study.~        -  For the next year, they will come back to the clinic or see their doctor at home at~          least every 3 months. They will answer questions about their health and blood will be~          drawn.~        -  For the next 5 years, they will go to the clinic or see their own doctor once a year.~          They will have physical exam and blood will be drawn.~        -  For 10 years after that, they will be asked every year for health information.~        -  Participants will keep their contact information up to date with researchers. They may~          be phoned for more health information.~        -  If the participant was under 18 years old when given the gene therapy and turns 18~          during this follow-up, they will be asked to sign a new consent form when they turn 18.~   "
56651|NCT02315586|"~     Background:~      - Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over~     time. There is currently no effective treatment for it. Researchers want to study the~     disease and learn new ways to treat it.~      Objectives:~      - To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs~     that may be used to treat pulmonary fibrosis.~      Eligibility:~        -  People at least 18 years old with IPF.~        -  Healthy volunteers at least 18 years old.~      Design:~        -  Participants will be screened with medical history, questionnaire, and physical exam.~          They will have blood, lung, and walking tests and chest scans.~        -  All participants will have 1 study visit, including:~        -  Medical history and physical exam.~        -  Questions about their breathing.~        -  Blood tests.~        -  Breathing tests.~        -  Six-minute walk test.~        -  Pregnancy test.~        -  Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ).~        -  Small area of skin may be removed.~        -  Genetic tests of blood and skin samples. Participants will probably not be informed of~          any findings. Samples may be used to make stem cells for use in research. Participants~          may be contacted in the future to give consent for this research.~        -  Some participants will have repeat visits over many years, repeating many of the study~          tests.~   "
56677|NCT02315248|"~     The purpose of this study is to validate a human saliva sample analyzer technique designed~     to screen for low bone density and osteoporosis. The analyzer technique is meant to be a~     simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone~     turnover using a point-of-care device that monitors salivary markers of bone turnover in a~     screening patient population that is at risk for low bone density or osteoporosis.~   "
56678|NCT02315235|"~     To investigate the efficacy and safety of autologous peripheral blood stem cell based~     therapy in patients with diabetic painful neuropathy.~   "
56654|NCT02315547|"~     Study 1 is a cross-sectional investigation. Patients with clinically stable bronchiectasis~     (symptoms, including cough frequency, sputum volume and purulence, within normal daily~     variations) will undergo baseline assessment consisting of history taking, routine sputum~     culture, 16srRNA pyrosequencing, measurement of sputum inflammatory markers, oxidative~     stress biomarkers and MMPs, and spirometry. Microbiota taxa will be compared between~     bronchiectasis patients and healthy subjects.~      In study 2, patients inform investigators upon symptom deterioration. Following diagnosis of~     BEs, patients will undergo the aforementioned assessments as soon as possible. This entails~     antibiotic treatment, with slightly modified protocol, based on British Thoracic Society~     guidelines [16]. At 1 week after completion of 14-day antibiotic therapy, patients will~     undergo convalescence visit.~      Study 3 is a prospective 1-year follow-up scheme in which patients participated in telephone~     or hospital visits every 3 months. For individual visit, spirometry and sputum culture will~     be performed, and BEs will be meticulously captured from clinical charts and history~     inquiry, with the final decisions adjudicated following group discussion.~   "
56655|NCT02315534|"~     This is an open label, multi-center, phase 1 safety run-in and phase 2 study of BBI608 in~     combination with temozolomide in patients with recurrent or progressive glioblastoma who~     have not received prior bevacizumab therapy.~   "
56656|NCT02315521|"~     The investigators propose a standardized prenatal management, based on the scientific~     evidence published in the literature, to manage prenatally fetuses with lower urinary tract~     obstruction (LUTO). The present study is a prospective registry that will evaluate and~     validate this standardized prenatal management for LUTO.~   "
56657|NCT02315508|"~     This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the~     treatment of tinnitus.~   "
56658|NCT02315495|"~     The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without~     acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin,~     C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the~     effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in~     patients with type 2 diabetes.~   "
56659|NCT02315482|"~     The purpose of this study is to assess the different effects of pneumoperitoneum and steep~     trendelenburg position on autonomic nervous system modulation during laparoscopic~     prostatectomy~   "
56660|NCT02315469|"~     This research trial studies comprehensive patient questionnaires in predicting complications~     in older patients with gynecologic cancer undergoing surgery. Comprehensive patient~     questionnaires completed before surgery may help identify complications, such as the need~     for assistance in taking medications, decreased mobility, decreased social activity, and~     falls, and may improve outcomes for older patients with gynecologic cancer.~   "
56661|NCT02315456|"~     The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of~     centration of the capsulorhexis- scanned capsule centration and pupil centration. It is~     hypothesized that scanned capsule centration provides more uniform(25% better) overlap of~     capsulorhexis margin over IOL optic compared to pupil centration.~   "
56662|NCT02315443|"~     The purpose of this study is to determine whether NA-1 is effective in reducing global~     disability in patients with acute cerebral ischemia if administered early after symptom~     onset.~   "
56663|NCT02315430|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is~     growing, spreading, or getting worse. Cabozantinib-s-malate may stop the growth of tumor~     cells by blocking the growth of new blood vessels necessary for tumor growth and also by~     blocking some of the enzymes needed for cell growth.~   "
56664|NCT02315417|"~     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of~     pyoderma gangrenosum (PG).~   "
56665|NCT02315404|"~     Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and~     treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy~     (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for~     diagnosis and treatment of bleeding originating from this part of the intestine.~     Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of~     patients. This may be due to limited visualization of the small bowel lining during~     conventional endoscopy. One way to improve visualization of the small bowel lining is by~     adding a transparent plastic cap to the end of the endoscope (camera), which allows the~     endoscope to see around sharp turned and behind folds in the small bowel.~      The investigators goal in this randomized controlled study is to see if adding a transparent~     cap to the end of the endoscope will help to identify and treat small bowel bleeding. The~     investigators will invite patients referred for BAE to participate in the study; the~     alternative to participating in the study is having standard BAE (without a cap). If~     patients choose to participate in the study they will be randomized to BAE with or without a~     cap on the end of the endoscope. Subjects time commitment will be limited to the consent~     process and pre-procedure paperwork at time of initial endoscopy and time required to~     complete telephone questionnaire at 12 months follow up.~   "
56666|NCT02315391|"~     The primary objective is to determine the effect of reduced activity on the stimulation of~     myofibrillar FSR with protein feeding in the elderly.~   "
56679|NCT02315222|"~     Patient with periodontal disease undergoing full mouth disinfection will be given dietary~     supplements or placebo and reevaluated after 3 months.~   "
56680|NCT02315209|"~     Outpatient services in Germany are less controlled by external quality assurance programs.~     Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g.~     for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has~     been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration~     of CSS as part of a multicentre quality assurance scheme for day-case (outpatient)~     surgery.b.The Study Group on Quality assurance in ambulatory hernia surgery has developed~     and standardized Operation technique for 3D Implants. As a consequence, any deviation must~     be documented by the standard. The extension to other centers according to a standardized~     protocol took place (shadowing to learn the operational standards, training in~     documentation, Minimum quantity 30 interventions per year, etc.).~   "
69377|NCT02149251|"~     Records of women who had Pre-genetic diagnosis (PGD) over the last 3 years will be reviewed~     and its outcome will be compared to other records of women who had IVF/ICSI without PGD.~   "
56667|NCT02315378|"~     This study is a randomized controlled trial to investigate the feasibility and effectiveness~     of a brief Anxiety Reduction Treatment for Acute Trauma (ARTAT) with adults (over age 18)~     showing signs of peritraumatic anxiety in the Emergency Department of Bellevue Hospital, New~     York in the hours following a psychologically traumatic event. Thirty-six participants will~     be enrolled over a 12-month period: 18 receiving ARTAT and 18 receiving Treatment As Usual~     (TAU). The study will target anxious arousal in patients immediately (1 to 8 hours)~     following a trauma. Participants will be recruited from among patients who present in the~     Emergency Department at Bellevue Hospital for treatment of an injury sustained in a~     traumatic event (accident, assault) as long as injuries do not preclude participation.~     Participants included in the study will have experienced a trauma within 8 hours and~     presenting with signs of a strong risk factor for PTSD: peritraumatic panic (severe~     psychological and physiological anxiety symptoms such as fear of dying, fear of losing~     emotional control, tachycardia, sweating, shaking and dissociation symptoms such as~     derealisation and depersonalization that occur during and immediately following a trauma.~     Following the initial assessment, eligible participants will be randomized to receive the~     one-hour anxiety-reduction intervention designed to reduce anxiety and panic symptoms~     through education and anxiety y management skills or TAU. The clinician administered and~     self-report assessments will be conducted at screening, baseline, post-treatment, weekly,~     and at a one-month and three-month follow-up.~   "
56668|NCT02315365|"~     This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the~     impact of current therapies on quality of life (QoL), productivity loss and health care~     resource utilization in metastatic breast cancer (mBC). This prospective study will estimate~     patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified~     according to treatment type, treatment line and disease status (progression vs. progression~     free) in a real-life setting.~      To estimate QoL, work productivity and health care resource utilization of post-menopausal~     patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting.~     The secondary objective is to estimate QoL and work productivity of mBC patients'~     caregivers.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients and caregivers will be asked to fill a set of questionnaires at their~     recruitment in the study, at 3 months and at 6 months after recruitment.~   "
56669|NCT02315352|"~     The primary objective of the trial is to compare the overall palatability of the new~     orally disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and~     the current available racemate PZQ tablets (reference) as assessed by means of human~     gustatory sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified~     by the incorporation of a 5 point facial hedonic scale).~      The secondary objectives are~        -  To obtain feedback from children regarding the taste of different formulations using an~          open ended questionnaire~        -  To document any discomfort or other observation in relation to acceptance of the study~          medication~   "
56670|NCT02315339|"~     The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation~     of HMV by documenting the characteristics of HMV patients and their treatment. This will~     facilitate a prospective, observational study to identify the primary indications for HMV,~     describe patterns of HMV use in European countries, and characterize changes in the~     initiation and utilization of HMV over time. The registry will target all adult individuals~     who have an indication for HMV. In the EHMVR, patient data from routine clinical care will~     be documented using an electronic case report form (eCRF). The eCRF will record: patient~     demographic data; diagnostic information (including primary diagnosis, 6-minute walk time,~     the presence of depression, and quality of life); blood gases; ventilation treatment~     (including type of ventilator, modes and settings, interfaces used); follow-up data~     (including failure rates, side effects, technical issues). An initial Pilot Phase will be~     launched with the aim to enrol at least 200 patients over a 6-month period to determine the~     feasibility of the registry. Steering committee members and their institutions will be the~     main participants in the Pilot Phase. After completion of the Pilot Phase, the registry will~     be expanded across Europe with the goal of enrolling approximately 10,000 patients over 5~     years.~   "
56671|NCT02315326|"~     The purpose of this study is to test any good or bad effects of the study drug called of~     ibrutinib (also known as Imbruvica™) at 840mg daily dosing has on the patient and the~     lymphoma in the central nervous system.~   "
56672|NCT02315313|"~     It is a retrospective study with no products limitation to investigate the link between~     clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with~     the control group and find out the correlation between HR and SOA indexes.~   "
56673|NCT02315300|"~     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)~     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).~     Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with~     CKD, and various studies have shown that hypoglycemic episodes are strong predictors of~     cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and~     small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about~     the direct association of hypoglycemic events and/or rapid swings in blood glucose with~     arrhythmias in this high risk population. Ideally, an algorithm should help to identify~     patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic~     analyses of blood glucose values and 12-channel ECGs are lacking in these patients.~   "
56674|NCT02315287|"~     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option~     in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed~     thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.~   "
56675|NCT02315274|"~     Hypothesis:~      Increased contact with the diabetes care team throughout pregnancy will lead to improved~     glucose control during pregnancy.~   "
56676|NCT02315261|"~     This study aims to evaluate the effectiveness of the epidural analgesia in patients having~     elective thoracic and abdominal surgery under general anesthesia combined with epidural~     analgesia in Siriraj Hospital.~   "
56705|NCT02314884|"~     A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability,~     Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients~     With Advanced Solid Tumors~   "
56681|NCT02315196|"~     This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and~     carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III~     breast cancer that does not have estrogen receptors, progesterone receptors, or large~     amounts of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative).~     Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride,~     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin followed by~     surgery and paclitaxel may be an effective treatment for breast cancer.~   "
56682|NCT02315183|"~     Acute kidney injury (AKI) complicates over 25% of cardiac surgical procedures where it~     increases mortality up to fourfold. The incidence of AKI is increasing, the pathogenesis is~     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is~     no effective treatment. Improving outcomes in patients at risk of AKI has recently been~     defined as an NHS priority. The primary aim of this study is to determine how plasma derived~     microvesicles (MV) or more specifically MV associated microRNAs (miRNA) regulate survival~     and signalling in post cardiac surgery AKI. The study involves a clinical and experimental~     research project that will combine laboratory analyses of circulating MV and miRNA from~     clinical studies. The study will specifically consider how MV and miRNA alter inflammatory~     signaling in kidneys after cardiac surgery, how these are modified by important clinical~     risk factors, and whether they may serve as early biomarkers of injury.~   "
56683|NCT02315170|"~     To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during~     and after intravitreal injections.~   "
56684|NCT02315157|"~     This phase I trial studies the side effects and best dose of bendamustine hydrochloride in~     treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such~     as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
56685|NCT02315144|"~     The primary objective of the study is to characterize the safety profile and duration of~     bronchodilation of a single dose of inhaled TV48108.~   "
56686|NCT02315131|"~     The primary objective of the study is to characterize the safety profile and duration of~     bronchodilation of a single dose of inhaled TV46017~   "
56687|NCT02315118|"~     Despite advancement in chemotherapy, radiotherapy and haematopoietic stem cell transplant~     (HSCT), and the recent introduction of more targeted therapies, a substantial proportion of~     patients with B-cell malignancies, such as B-cell chronic lymphocytic leukemia (CLL) and~     B-cell non-Hodgkin's lymphoma (NHL) still succumb to their malignancies. For CLL and~     low-grade NHL, cure is achievable only with HSCT but such aggressive approach is not~     justified as the initial therapy for most patients who have indolent disease; when disease~     has progressed, transplant is either not feasible or ineffective. For high-grade B-cell NHL,~     the availability of Rituximab has improved disease outcome but treatment failure portends~     nearly inevitable death from disease or treatment-related complications. Thus, newer, more~     effective therapies for patients with B-cell malignancies are urgently needed.~      The present study translates recent laboratory findings into clinical application. In~     patients with B-cell malignancies receiving the anti-CD20 antibody Rituximab as standard~     therapy, the study aims to assess the feasibility and safety, as well as explore the~     efficacy, of infusing autologous T-lymphocytes engineered to express a CD16-41BB-CD3zeta~     chimeric receptor which mediates antibody-dependent cell cytotoxicity. Receptor expression~     is achieved by electroporation of mRNA.~   "
56688|NCT02315105|"~     The purpose of this study is to find out more about the safety and effectiveness of the~     Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and~     related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep~     apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some~     of the other weight loss surgeries and it is possible that there are fewer risks with this~     procedure than with the other weight loss surgeries. LGCP is considered an experimental~     procedure and this study is being done to look at the long-term outcomes.~   "
56689|NCT02315092|"~     The current trial aims to compare the assessment of diabetic foot ulcers by fluorescence~     image guidance to standard practice. The device will be used to acquire fluorescence images~     of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic~     bacterial species emit a unique red fluorescence signal. The device is intended to be used~     as part of the clinical assessment process, which may include visual assessment, signs of~     heat or high temperature, the presence of exudate, and redness in the area. Images will~     guide the clinician to inspect, sample or further evaluate areas where fluorescing bacteria~     is present. This study will allow us to determine the benefit of fluorescence image-guided~     procedure as compared to standard clinical practice to assess bacterial burden in diabetic~     foot ulcers. Microbiological swabbing under standard practice and fluoresce-guided imaging~     will be performed in order to compare the two techniques.~   "
56690|NCT02315079|"~     To evaluate the use of a point of care device to measure markers of inflammation in various~     eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is~     an enzyme that plays a role in inflammation. The value obtained with the point of care~     device will be correlated with values obtained using gel electrophoresis to measure MMP-9~     from the same sample. These data will be compared to clinical exam findings and~     questionnaires to help the investigators better understand the role of this marker of~     inflammation in eye diseases and possibly improve diagnostic abilities.~   "
56691|NCT02315066|"~     To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in~     combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in~     order to determine the maximum tolerated dose and select the recommended Phase 2 dose.~   "
56692|NCT02315053|"~     A prospective observational study to determine the prognostic value of the timing of 50%~     reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).~   "
56781|NCT02313883|"~     A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel~     Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and~     Root Planing in Subjects with Periodontitis~   "
56693|NCT02315040|"~     Overall Study Design and Plan Description~        -  The study will be conducted on women with fertility difficulties who are designated for~          intrauterine insemination treatment (IUI). The research sample size is 137 treatment~          cycles per group (total of 274 treatment cycles). The women will be randomly divided~          into two groups. Some will undergo the standard bolus IUI treatment and others will be~          treated with the EVIE Slow Release Insemination method (SRI). Women who fail to~          conceive in the first treatment will next receive the alternative treatment. This means~          that a woman treated with the IUI method who does not become pregnant will then be~          treated with SRI, and vice versa (crossover method). The study will include women~          treated with Clomiphene Citrate or with other Gonadotropin-based treatment. Every~          couple treated will undergo at least 2 insemination cycles (unless pregnancy has~          already been achieved).~        -  Before beginning the hormone treatment, each couple will have the trial procedure~          explained to them. This explanation will include all the detailed information and~          instruction about the IUI and the Slow Release Insemination methods. A Patient~          Information Sheet will be available to them.~        -  Preparation of the spermatozoa for intra uterine insemination will be identical to the~          method performed currently before IUI.~      Approximately two weeks after the insemination treatment, a blood sample will be taken from~     the woman to check for Beta hCG levels to indicate pregnancy.~      Hypothesis:~      SRI leads to higher pregnancy rates compared to standard IUI~      Primary endpoint:~      • Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the~     pregnancy rate of women designated for intra uterine insemination in comparison to the~     accepted IUI method.~   "
56694|NCT02315027|"~     The purpose of this study is to determine whether mesenchymal stem cells (MSCs) can be~     safely delivered to the cerebrospinal fluid (CSF) of patients with multiple system atrophy~     (MSA). Funding Source - FDA OOPD.~   "
56695|NCT02315014|"~     To determine whether a balanced total daily dietary protein distribution supplemented with~     whey protein during a weight-loss intervention will result in increased muscle protein~     synthesis~   "
56696|NCT02315001|"~     A single-centre double-blind placebo-controlled crossover randomised controlled trial to~     determine the physiological basis of glucagon-like peptide-1 receptor activation on exercise~     haemodynamics, as manifest through specific electrophysiological parameters measured by~     serial exercise stress testing, in those patients with reversible myocardial ischaemia and~     obstructive coronary artery disease confirmed by a baseline exercise test and coronary~     angiography respectively.~   "
56697|NCT02314988|"~     This study is designed to evaluate the efficacy of topical tranexamic acid to reduce~     perioperative blood loss, reduction in postoperative drain output and allogenic transfusion~     requirements.~      The proposed study will be a prospective, randomized, double-blind (subject, surgeons,~     investigators, research coordinators) placebo-controlled study. Patients following high~     energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or~     ligamentous injury with resultant instability requiring posterior spinal fusion will be~     enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery~     will also be enrolled. Both populations of patients will be randomized into two groups.~     Group I will receive standard of care operative fixation with topical tranexamic acid~     intervention (test); Group II will receive standard of care operative fixation with normal~     saline (placebo) intervention. This study will have a 2-year follow-up and will consist of~     three periods: screening/enrollment phase up to 21 days from the day of injury to the day of~     randomization and operative intervention, an inpatient data collection period for 4 days~     postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2~     week, 16 week, 1 year, and 2 year) time points.~   "
56698|NCT02314975|"~     The aim of this study is to compare the clinical efficiency of conventional fixed appliance~     orthodontic treatment with that supplemented by the daily application of cyclic forces to~     the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome~     measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and~     discomfort during treatment, rapidity of orthodontic space closure, changes in arch~     dimensions and root length.~   "
56699|NCT02314962|"~     Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT~     and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR~     perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly~     prognostic.~   "
56700|NCT02314949|"~     An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft~     protective mechanisms was applied in a clinical cohort of 13 intestinal transplant~     recipients to activate - in a protolerogenic environment - T-regulatory cells.~      This protocol is the standard of care in the investigators intestinal transplant programme~     since the first intestinal transplant was performed in october 2000.~   "
56701|NCT02314936|"~     This study will investigate the effectiveness of Polydextrose, a dietary fiber, at~     increasing Colonic Transit Time and decreasing the gastrointestinal symptoms of Functional~     Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one~     quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose~     daily and one quarter will receive a placebo daily.~   "
56702|NCT02314923|"~     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola~     vaccine BPSC-1001 to see if it is safe and to see how it affects people's immune system.~   "
56703|NCT02314910|"~     If implants are osseointegrated, there might be innervation of the bone close to the~     implants. This event might explain the so-called osseoperception phenomena: Functioning with~     implant-supported oral prostheses is better than with removable prostheses due to~     physiologic integration and thus sensory feedback.~   "
56704|NCT02314897|"~     Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves~     placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex.~     It is now known that tricuspid regurgitation (TR) frequently results from this and may lead~     to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an~     epicardial vein via the coronary sinus has been widely practiced due to the advent of~     biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV~     dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize~     that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients~     undergoing pacemaker implantation.~      Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection~     fraction <40% will be randomly allocated to receive either conventional RV pacing or LV~     pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be~     performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months~     and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least~     moderate TR. Other endpoints include biventricular function, ventricular dyssynchrony,~     complications of device implantation, mortality and major cardiovascular events.~   "
56706|NCT02314871|"~     The aim of this study is to compare the effects of three types of perioperative analgesia on~     the number of circulating cancer cells (representing minimal residual disease) following~     radical colon cancer surgery. Patients will be randomized into one of three groups. The~     intervention group will receive combined regional and general anesthesia during surgery and~     postoperative epidural analgesia. The two control groups will receive balanced general~     anesthesia and either morphine-based or piritramide-based postoperative analgesia. We~     hypothesize that epidural analgesia will be favorable to both piritramide-based and~     morphine-based analgesia and that piritramide-based analgesia will be favorable to~     morphine-based analgesia with regard to the number of circulating cancer cells and its~     development in the early postoperative period.~   "
56707|NCT02314858|"~     Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious~     medical condition with significant medical and psychological consequences, including~     diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is~     Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway~     creating a pneumatic splint to keep the airway open during sleep. Adherence to PAP is~     notoriously low, with as few as 50% reaching minimal guidelines for adherence. One~     comprehensive review of adherence research found that adherence to PAP was less than that~     for any other medical disorder. The problem of adherence is significant not only because of~     the medical consequences that can ensue, but also because third party payers have begun to~     refuse to pay for PAP therapy when adherence is less than optimal, even in the face of~     clinical improvement. This is a critical time to address this problem.~      This research study is designed to identify methods that may help people respond to PAP, the~     most common therapy for OSA. Identifying these methods may be an important way to better~     care for patients with obstructive sleep apnea. With this research, the investigators hope~     to find ways to help people have a better response to treatment and a better quality of~     life.~   "
56708|NCT02314845|"~     The purpose of this randomized single center study is to determine the individual PEEP value~     that produces the best possible compromise of lung collapse and lung hyperdistention.~     Patients submitted to general anesthesia and mechanical ventilation during surgery~     (laparoscopy and open surgery) will participate. A PEEP titration procedure will be~     performed and the optimal PEEP value will be determined by electrical impedance tomography~     (EIT). An ultrasound will be used to record each step of the PEEP titration procedure in a~     sub-sample of patients. A total of 40 patients will be mechanically ventilated using~     physiological tidal volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5~     and will be randomized to one of two groups: optimal PEEP or a low PEEP (4cmH2O). Lung~     collapse and mechanics will be monitored by EIT throughout the intraoperative period. After~     extubation, a lung CT will be performed to evaluate the amount of lung collapse.~   "
56709|NCT02314832|"~     Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve~     plays an important role in pain control after total knee replacement. However, femoral nerve~     block has been associated with increased risk of falls due to weakness of the thigh muscle.~     This prospective, randomized controlled trial asks the question whether blocking the more~     distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block,~     and thus less risk of falls. The study also aims to compare pain control after both~     techniques.~   "
56710|NCT02314819|"~     Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on~     and one week off) was well tolerated and demonstrated encouraging preliminary clinical~     antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase~     2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the~     treatment of patients with metastatic CRC who have progressed after second line or above~     standard chemotherapy~   "
56711|NCT02314806|"~     The patients undergoing axillary lymph node dissection were randomized into 3 groups:~     patients undergoing lavages with normal saline (Group 1), patients undergoing lavage~     gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution~     (Group 3). Drainage volume discharge is investigated~   "
56712|NCT02314793|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     oral doses of ASP2205 in healthy young male and female subjects. This study will also~     evaluate the safety and tolerability of multiple ascending oral doses of ASP2205 in healthy~     young and elderly female subjects.~   "
56713|NCT02314780|"~     Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed~     strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy~     humans5. Furthermore, we could demonstrate the amelioration of experimental ischemia~     reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured~     by functional MRI6.~      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to~     mitigate cardiac ischemia-reperfusion injury.~      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and~     after aortic cross clamping in subjects with or without preceding heme arginate treatment in~     two different dosages. The HO-1 expression will also be measured in the clinical trials in~     peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,~     creatine-kinase and troponin T and reactive oxygen species will be measured in plasma~     according to standard laboratory procedures.~   "
56714|NCT02314767|"~     Lohja Depression Treatment Study is a randomized treatment trial which compares three~     approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2)~     Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims~     to test and adapt known short term treatment models for Finnish patients and circumstances.~   "
56715|NCT02314754|"~     To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48~     hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77~     days' compared to women 64-70 days' LMP.~   "
56749|NCT02314312|"~     Single center, open-label randomized-control trial Population: de novo 48 kidney transplant~     recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and~     prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of~     everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors~     Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation~   "
69508|NCT02147548|"~     The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared~     to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the~     elderly.~   "
56716|NCT02314741|"~     The investigators wish to monitor the adoption of a new, incisionless approach to performing~     a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic~     Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally~     providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The~     investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet~     inclusion criteria.~      The POEM procedure has been done in many hospitals without any research associated with it.~     Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being~     trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has~     performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first~     case to be proctored by an experienced operator. The PI will then proctor the other~     adopters. The investigators would like to evaluate the safety of it and the effectiveness of~     it. The investigators will use their symptom scores and radiology tests pre- and post-POEM~     to evaluate effectiveness.~   "
56717|NCT02314728|"~     Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the~     vaginal canal before the onset of labor. The integrity of the amniotic membrane is~     compromised thereby increasing the risk of intrauterine infection and compression of the~     umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for~     30% of preterm births. Intrauterine infection remains the most significant maternal and~     neonatal sequelae associated with PROM and this risk increases with the length of time from~     ruptured membrane to delivery. Induction of labor has been shown to reduce the rates of~     chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with~     prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be~     effective for labor induction resulting in vaginal delivery. Management strategies for PROM~     have been controversial, and published studies on outcomes are over one to two decades old,~     which does not account for changes in clinical trends and practice patterns. Recently ACOG~     recommends that patients presenting at 37 weeks gestation or greater with PROM should be~     induced if not in labor, and generally with oxytocin. In women with PROM without the onset~     of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to~     an increased risk of cesarean section. With a c-section rate as high as 33%, women~     undergoing induction of labor have an increased risk of c-section and its associated~     morbidity and long term sequela. ACOG's recommendation for the use of oxytocin as the~     induction agent may be meant to avoid a theoretical increased risk of chorioamnionitis in~     this patient population however it does not take into account the status of the cervix,~     which may result in a increased risk of c-section. The purpose of the proposed study is to~     determine whether cervical ripening in women with PROM and an unfavorable cervix is~     associated with increase rates of vaginal delivery and decreased cesarean section rate~     compared to induction of labor with oxytocin alone. The investigators aim to determine the~     incidence of endometritis, and neonatal infection associated with PROM in the current~     medical environment of antibiotic prophylaxis and antenatal steroid use, taking into account~     the changes in patient characteristics.~   "
56718|NCT02314715|"~     Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA)~     the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years~     is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is~     the leading cause of limitations in activities of daily living such as walking and climbing~     stairs particularly in the elderly. This is primarily due to pain and instability of the~     joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage.~     Patients with KOA have larger variations in muscle strength and are unable to maintain a~     target force combined with impaired ability to perceive joint movement and positioning~     suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous~     system's control over muscle activation contributing to task performance. This study aims to~     establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.~   "
56719|NCT02314702|"~     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and~     efficacy of its THA and resurfacing components marketed in the EU. These types of studies~     are required by regulatory authorities for all THA and resurfacing devices that do not have~     medium to long-term clinical evidence available at the time of gaining approval to market in~     the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
56720|NCT02314689|"~     The purpose of this study is to assess the maximum tolerated dose, safety and~     pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in~     steady-state sickle cell disease.~   "
56721|NCT02314676|"~     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)~     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad~     population of children. Half of participants will receive the high dose, while the other~     half will receive the low dose.~   "
56722|NCT02314663|"~     Background In subjects with hypercholesterolaemia, cholesterol values remain above guideline~     levels. One of the limiting factors to the achievement of goals in such patients is~     therapeutic non-adherence. The aim of this study is to assess the effectiveness of an~     intervention designed to improve control of hypercholesterolaemic patients, consisting of a~     combined strategy that would include the delivery of printed information,~     treatment-compliance check cards and the dispatch of text messages as complementary measures~     in support of the intervention at the general practitioner's practice.~      Methods/Design A randomised, parallel-group clinical trial will be conducted at the family~     medicine outpatient facilities of eight health centres in three of Spain's Autonomous~     Regions, covering a total of 358 subjects aged 18 years or over with diagnosis of~     hypercholesterolaemia. Patients in the intervention group will be supplied with printed~     material with information on the disease and its management, mobile-telephone text messages~     with guideline summaries, reminders of forthcoming appointments and/or arrangements for~     making new appointments in the event of non-attendance, and self-report cards to check~     compliance with recommendations. Both groups -intervention and control- will receive routine~     recommendations from their physicians in accordance with current European clinical practice~     guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the~     measurements to be made, the main variable is the proportion of subjects who attain the low~     density lipoprotein cholesterol levels set as a target across a follow-up period of 24~     months. The secondary variables are as follows: adherence to recommendations on lifestyle~     and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels;~     appearance of cardiovascular events; physical activity; food consumption; smoking habit;~     anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents;~     socio-demographic data; beliefs and expectations about preventive recommendations; and~     degree of satisfaction with the combined strategy.~      Discussion Should this intervention prove effective, a recommendation could be issued on the~     application of this combined strategy to subjects with hypercholesterolaemia. It is a~     simple, relatively inexpensive intervention.~   "
56723|NCT02314650|"~     The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during~     general anesthesia could reduce the need for propofol in patients undergoing minor surgery.~   "
56724|NCT02314637|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin)~     as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with~     type 2 Diabetes for 52 weeks administration.~   "
56750|NCT02314299|"~     This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in~     one of the two treatment groups to determine the effects of topical ocular administration of~     low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and~     Age-Related Macular Degeneration.~   "
57104|NCT02309658|"~     The propose of this study is to determine if neoadjuvant chemotherapy followed by~     chemoradiation is safe and effective in locally advanced cervical cancer patients. Moreover,~     the study would determine if there is any association between hENT1 expression and response~     rate to gemcitabine.~   "
56725|NCT02314624|"~     The ultimate goal is to facilitate the delivery of empirically supported treatments (ESTs)~     for mental disorders and to improve client mental health outcomes. Toward this end, this~     Phase II SBIR proposal seeks to complete the development and testing of PracticeGround, a~     comprehensive software system designed to integrate with electronic health records, and that~     contains multiple methods of training clinicians in ESTs and delivering ESTs to clients,~     continuous progress monitoring of client outcomes, and clinical support tools to guide~     clinicians and clients through delivery of the necessary EST. The investigators will conduct~     an 18-week randomized controlled trial (N=80) comparing PracticeGround (n=40) to~     care-as-usual (n=40) in depressed outpatient clients. PracticeGround clinicians will have~     full access to the software. Study clinicians and clients will be assessed once every six~     weeks (baseline, 6, 12, and 18 weeks). To ensure generalizability of findings, the~     investigators will not control for natural therapy variations (e.g.,session frequency,~     medication use, etc.). Primary outcomes include: depression, psychological distress,~     treatment satisfaction (clients and clinicians), and treatment drop out. Secondary clinician~     outcomes include: extent of PracticeGround use with clients across clinicians' caseload.~   "
56726|NCT02314611|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study~     to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
56727|NCT02314598|"~     This is a prospective, non-randomized, multicenter, post market release study which will~     collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the~     high voltage portion of the defibrillator lead and will evaluate the electrogram signals.~   "
56728|NCT02314585|"~     This study looks to see the effects of a home based exercise program on falls in people with~     MS.~   "
56729|NCT02314572|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.~   "
56730|NCT02314559|"~     Deep sedation with propofol for ambulatory colonoscopy has become standard clinical~     practice.To achieve the necessary (e.g.: no excessive movement and no awareness) level of~     sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by~     target controlled infusion.~      The aim of the investigators is to evaluate sedation efficacy and recovery between two~     groups of ambulatory patients having a colonoscopy: one group will receive a manual~     titration of propofol, the other group a target controlled infusion (TCI) of propofol. The~     investigators will evaluate both groups before, during and after colonoscopy for adverse~     events, quality of sedation and recovery. When patients are estimated to be ready for~     discharge, they will also be subjected to a cognitive and a psychomotoricity test.~   "
56731|NCT02314546|"~     The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal~     midazolam makes giving the midazolam easier and more comfortable without affecting how the~     midazolam works as a sedative.~   "
56732|NCT02314533|"~     The investigators design this prospective, open-label, parallel, controlled study to~     investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top~     of statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.~   "
56733|NCT02314520|"~     The goal of this study is to determine whether Peripherally Inserted Central Catheter or~     Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience~     Intensive Care Unit. After admission to the Neuroscience ICU and if they require central~     access, patients will be randomized to receive a PICC or CVC and complications (such as~     pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between~     the two interventions.~   "
56734|NCT02314507|"~     The purpose of the study is to investigate whether Gua sha is an effective modality for~     relieving chronic low back pain specifically in the aged population by comparing the~     baseline measures of pain intensity, self-perceived disability, back range of motion, back~     local muscle stiffness, depression, sleeping quality, quality of life, biomarkers~     measurement, and analgesic intake on days 1 and 7 after a single session of Gua sha~     treatment. In addition, the investigators are going to compare between Gua sha and hot pack~     treatments for the above parameters.~   "
56735|NCT02314494|"~     Children who are above healthy weight are more likely to be ill and to miss time off school.~     Being overweight in childhood can also sow the seeds for health problems in later life such~     as heart disease and diabetes. Most overweight children become overweight adults. One~     solution is to try to prevent children becoming overweight by intervening very early in~     life. The risk factors for childhood overweight are known and this project aims to~     facilitate parents' (and other carers') understanding about this for their infant and to~     enable them to access intervention. UK health visitors (public health nurses) will use an~     interactive, multimedia programme (Proactive Assessment of Overweight Risk during infancy~     (ProAsk)), with parents to calculate their infant's risk and to discuss strategies for risk~     reduction as appropriate. Health visitors will be trained to communicate obesity risk and in~     Motivational Interviewing techniques to enable them to offer intervention to parents of~     infants identified as at risk.~      A feasibility study of ProAsk will take place in two health provider organisations in the~     UK. The purpose of this is to a) determine the acceptability and utility of the ProAsk~     intervention with health visitors and parents and b) gather information to inform the trial~     design and data collection procedures for a future Randomised Controlled Trial (RCT).~   "
56764|NCT02314117|"~     The main purpose of this study is to evaluate the effectiveness of ramucirumab, which is a~     targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine~     and cisplatin alone in participants with stomach cancer.~   "
56792|NCT02313740|"~     Prospective cohort study to evaluate safety and immunogenicity of the fragmented,~     inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and~     elderly. The study will include a total of 120 participants: 60 participants aged 18 to 59~     years in the healthy adults group, and 60 participants aged older than 60 years in the~     elderly group.This study will evaluate the safety of one dose of the fragmented, inactivated~     trivalent Influenza vaccine in the first 3 days after vaccination, as well as its~     immunogenicity 21 days after vaccination.~   "
56736|NCT02314481|"~     DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who~     relapse with NSCLC (clinical trials.gov ref. NCT02183883),~      The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal~     actionable mutation) is associated with PFS.~      Patients 1) without an actionable mutation and PDL1 positive or 2) without an actionable~     mutation and PDL1 negative following first line cytotoxic chemotherapy, will receive~     MPDL3280A a monoclonal antibody targeting anti-PDL1.~      Patients with BRAFV600 mutations, Her2 Amplification, ALK/RET gene rearrangements will be~     enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib~     respectively.~      DARWIN II will include extensive exploratory biomarker analysis to investigate a number of~     genomic and immune markers that may predict response to MPDL3280A and help guide future~     clinical trial design.~   "
56737|NCT02314468|"~     Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of~     pathologies, all characterized by an infectious state, typically arising after a penetrating~     trauma or a surgical procedure and an expeditious spreading of necrosis throughout the soft~     tissues of the body. It is a rare, life-threatening and devastating infection defined by a~     necrosis of fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove~     all necrotic tissue and define the extent of the disease is still the mainstay of correct~     treatment of NSTI.~      Both negative pressure wound therapy (NPWT) and the application of allograft skin to~     debrided areas, are documented options for wound bed preparation which are standard in the~     university hospital of Gent.~      NPWT is a technique for wound bed preparation involving the controlled application of~     sub-atmospheric pressure to the local wound environment, using a sealed wound dressing~     connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in~     blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation~     of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of~     edema, and bacterial clearance.~      Allograft skin or cadaveric skin possesses many of the ideal properties of biologic~     dressings, and plays a major role in the surgical management of extensive wounds when~     autologous tissue may not be immediately available. It reduces evaporative water loss and~     the drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial~     proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at~     the wound surface. Enhancing revascularization, and thereby creating a viable wound bed~     before final reconstruction, is perceived as one of the most important features of~     allografting.~   "
56738|NCT02314455|"~     To determine how the esophagus in active and inactive stages of eosinophilic esophagitis~     tranmit fluids.~   "
56739|NCT02314442|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.~   "
56740|NCT02314429|"~     In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases~     lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy~     volunteering women and left in place for 7 days. The primary objective of this phase I study~     is to assess the safety and the tolerability of this new intravaginal delivery system.~      The eventual goal of this and related studies is to develop a vaginal ring that reduces~     recurrences in women suffering from bacterial vaginosis, which is the commonest form of~     vaginal infection.~   "
56741|NCT02314416|"~     The purpose of the study is to use a collagen matrix embedded with amniotic stem cells to~     speed up the maturation and integration of the collagen matrix in the wound bed and shorten~     total time needed for wound healing.~   "
56742|NCT02314403|"~     This study will examine the safety and effectiveness of a combination kidney and bone marrow~     transplant from a haplo-identical related donor. An investigational medication and other~     treatments will be given prior to and after the transplant to help protect the transplanted~     kidney from being attacked by the body's immune system~   "
56743|NCT02314390|"~     The purpose of this study is to determine whether both group and individual~     mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in~     patients with a chronic somatic disease.~   "
56744|NCT02314377|"~     Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical~     intervention.~   "
56745|NCT02314364|"~     This research study is studying a type of radiation therapy called Stereotactic Body~     Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer~     (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced~     anaplastic lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (=~     oncogene-driven NSCLC) and for which the subject has been receiving treatment with a~     targeted biological agent such as erlotinib, crizotinib, or other drugs.~   "
56746|NCT02314351|"~     Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous~     metoclopramide was a commonly used drug in the acute abortive treatment of migraine.~     However, the role of metoclopramide was based on three randomized, placebo-controlled~     studies, which were carried out with relatively few patients. Those trials suggested that~     metoclopramide produced larger improvements in visual analog scale (VAS) scores, however~     they revealed conflicting results and had significant methodological problems (risk of bias,~     allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse~     the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.~   "
56747|NCT02314338|"~     Patients with COPD often have limitations to physical performance. There are several tests~     for evaluating physical performance, unfortunately many of them can be time consuming and~     require specialized equipment an substantial space. Short physical performance battery is a~     simple test that requires little resources and can be performed both at institutions and in~     the homes of patients. SPPB has high predictive abilities in identifying older adults at~     greater risk for mortality, nursing home admission, hospitalization, and incidence of~     disability. The investigators would like to evaluate possible changes in the SPPB score~     after a 4-week rehabilitation program. The investigators would also like to look at possible~     relationships between the SPPB and other physical performance measures, dyspnea, anxiety,~     depression, fatigue, and health related quality of life.~   "
56748|NCT02314325|"~     This trial is designed to assess if there is evidence of subclinical joint bleeding on~     MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically~     tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal~     MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on~     standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant~     Factor VIII prophylaxis.~   "
56793|NCT02313727|"~     It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for~     pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while~     randomization will be performed for pamidronate versus placebo group. Primary outcome will~     be the rate of radiographic progression of AS, calculated after 24 months of combined~     treatment.~   "
56751|NCT02314286|"~     Prospective randomized single blind trial. Study population are women diagnosed with severe~     pre-eclampsia during singleton pregnancy, between 24+0 weeks and 41+6 weeks gestational age.~     The purpose of the study is to evaluate the effect of Rosuvastatin on the severe~     preeclampsia resolution at 48 hours after delivery. After screening and signing an informed~     consent form, before entering delivery room, a randomization 1:1 will be carried. 50 women~     will be in the treatment arm while 50 will be in the control arm. Both groups will be~     treated according to ACOG (The American College of Obstetricians and Gynecologists has the~     following clinical guidelines related to deliveries before 39 weeks) guidelines. In~     addition, following randomization experimental group will be treated with Rosuvastatin 40mg~     that will be administrated orally with or without food. Treatment will be carried within the~     first hour following delivery. Another dose will be given 24 hours after first~     administration. Control group will be treated with placebo.~   "
56752|NCT02314273|"~     The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may~     increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who~     develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine~     arabinoside+mercaptopurine，7d） therapy.~   "
56753|NCT02314260|"~     To have an early more precise way to predict failed induction in patients undergoing~     elective termination of pregnancy & those more likely to undergo caesarian section,this will~     Spare patients with decreased chances of favorable induction a long and exhausting trial of~     labour with increased probability of complications and an emergency caesarian~   "
56754|NCT02314247|"~     This is a single-arm, multi-center, open-label Phase II study of the SINE™ compound~     Selinexor given orally to patients with relapsed/refractory PTCL and CTCL.~      Approximately 60 patients with relapsed or refractory PTCL and CTCL who meet the eligibility~     criteria and have none of the exclusion criteria will be enrolled to receive Selinexor until~     either disease progression or intolerance has occurred.~   "
56755|NCT02314234|"~     To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block~     by sugammadex during IONM of facial nerve during parotid surgery~   "
56756|NCT02314221|"~     The primary objective of this study is to achieve successful walking skills using~     exoskeletal walking devices over the course of 36 sessions in 3 months at specific~     velocities and distances in people with chronic SCI who are wheelchair dependent for~     community mobility. The secondary objectives are to determine if this amount of exoskeletal~     walking is effective in improving bowel function and body composition in the same patient~     population. The exploratory objectives are to address additional questions concerning the~     retention or non-retention of the positive changes, the effects of the increased physical~     activity from this intervention on vagal tone, orthostatic tolerance, lipid profile, total~     testosterone, estradiol levels, and quality of life (QOL).~      A Phase III randomized clinical trial (RCT) will be performed using a crossover design and~     employing an exoskeletal-assisted walking intervention. The experimental arm will be~     compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6~     month post injury) who are wheelchair-dependent for outdoor mobility in the community. The~     WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions~     per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will~     consist of identification of usual activities for each participant, encouragement to~     continue with these activities and attention by study team members throughout the 12-week UA~     arm. These activities will be recorded in a weekly log. The investigators hypotheses are~     that 1) this exoskeletal intervention will be successful in training ambulatory skills in~     this patient population, 2) the exoskeletal intervention will be better than a control group~     in improving body composition, bowel function, metabolic parameters and quality of life in~     the same population.~   "
56757|NCT02314208|"~     The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox,~     Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the~     synthesis of cholesterol and/or regulate the production of bile acids and/or enabling~     neuroprotective action within the motor neuron.~   "
56758|NCT02314195|"~     Previous studies have highlighted the potential therapeutic benefits of receptive individual~     music therapy as an adjunct to standard care, in a variety of psychiatric ailments including~     mood and anxiety disorders. However, the role of music in the treatment of obsessive~     compulsive disorder have not been investigated to date. The present study therefore aimed to~     investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions~     in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion~     of patients with OCD have other comorbid mood or anxiety disorders, the question of whether~     therapeutic benefits of music could be expanded to also affect concurrent depressive and~     anxiety symptoms was explored.~   "
56759|NCT02314182|"~     A prospective, open, multicenter, randomized III trial with two arms:~        -  Arm A: Primary tumor resection , followed by chemotherapy~        -  Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated~          for resectable rectal adenocarcinoma with unresectable metastasis, treated either with~          the primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy~          (+/- target therapy) alone.~   "
56760|NCT02314169|"~     This phase II trial studies how well nivolumab works in treating patients with anal canal~     cancer that has not responded to previous treatment (refractory) and has spread to other~     places in the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor~     growth in different ways by targeting certain cells.~   "
56761|NCT02314156|"~     This randomized trial studies transdermal or oral telapristone acetate in treating patients~     undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent~     breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally~     may be safer and have fewer side effects than oral administration.~   "
56762|NCT02314143|"~     This is a three-arm, open-label, randomised Phase II study to evaluate whether the different~     sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an~     impact on translational or clinical activity in subjects with BRAF mutant metastatic~     unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated~     clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However,~     duration of responses seem to be limited due to acquired drug resistance. The goal of this~     protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and~     tumour biomarkers and to study the correlation between biomarkers and response to treatment~     and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the~     ratio of 1:1:1 to one of the three treatment arms.~   "
56763|NCT02314130|"~     The objective is to evaluate the effect of no-commercial enteral diet for patients in home~     nutritional therapy in anthropometric and biochemical indices comparing to patients using~     commercial enteral diets.~   "
56765|NCT02314104|"~     The purpose of this study is to determine if there is a better method of administering pain~     medication prior to minimally invasive gynecological surgery so that postoperative pain~     and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the~     use of local pain medications in minimally invasive gynecological surgery and practices vary~     widely among physicians, even within the same institution.~      The two methods of preemptive pain medication that this study will be looking at is the~     transversus abdominis plane (TAP) block and the local injection of pain medication at the~     areas of the skin incisions. TAP block is a procedure performed by a specially trained pain~     management anesthesiologist in which there is an injection of a local pain medication into~     the abdominal wall, specifically in a space where the nerves that are responsible for~     postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and~     has been found to be successful in decreasing postoperative pain in a number of procedures.~     The local injection of pain medications at the incision sites has also been found to be~     beneficial in decreasing postoperative pain. However, it is not known whether one method is~     superior to the other in decreasing postoperative pain or if the combination of both is~     best.~      Patients that chose to participate are randomly (by chance) assigned to one of three groups:~     1) TAP block with pain medication and local injection of normal saline (water) at the~     incision sites 2) TAP block with normal saline and local injection of pain medication at the~     incision sites or 3) TAP block with pain medication and local injection of pain medication~     at the port sites. These procedures are performed while the patient is asleep. Patients will~     be asked to record their level of pain on a standardized pain scale at one hour, six hours,~     and twenty-four hours after the surgery. All patients are provided with standard~     postoperative pain medications as needed.~      The hypothesis is that patients receiving both TAP block and local injection of pain~     medication at the port sites will have less pain postoperatively and require a smaller~     amount of narcotics than those that receive either the TAP block or local injection of pain~     medication alone.~   "
56766|NCT02314091|"~     Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional~     hernia~   "
56767|NCT02314078|"~     A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is~     the standard of practice recommended by clinical guidelines.~   "
56768|NCT02314065|"~     Background~      Severe health anxiety is a highly distressing, often debilitating, psychological problem.~     Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its~     clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD)~     or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several~     treatments for severe health anxiety have shown great promise, the most well-established~     being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other~     psychotherapies - has typically been delivered face-to-face. That is, the patient physically~     meeting with the therapist once a week for the whole of the treatment. Internet-delivered~     CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for~     severe health anxiety (see for example NCT01673035).~      Aim of the study~      The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face~     for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is~     applied to determine if Internet-delivered CBT is at least as efficacious as its~     well-established predecessor.~   "
56769|NCT02314052|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid~     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to~     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor~     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell~     growth.~   "
56770|NCT02314039|"~     This cross sectional questionnaire based study will aim at exploring psychological factors~     at play in the experience of acne, and their association with perceived and clinical~     severity. We will focus in particular on the role of psychological trauma in the patients~     with acne and their wellness. This project is being undertaken as part of a wider developing~     initiative in the Dermatology Department within NHS Tayside, which aims at identifying and~     consequently addressing the psychological needs of their patients. Participants will be~     consecutive patients with acne aged at least 18 years old, seen in the outpatient clinics of~     the Dermatology Department in NHS Tayside. Potential participants will be informed about the~     research by their clinician during an outpatients appointment and if interested, given an~     information sheet and consent form to review. Verbal consent will be sought by the clinician~     to give the potential participant's contact details to the Chief Investigator (CI)/Research~     Assistant (RA). If agreeable, the CI/RA will contact the potential participant after at~     least 24 hours to arrange a mutually agreed time for meeting. If the potential participant~     are still keen to participate and has read the information sheet, fit our inclusion~     criteria, are not deemed to be distressed by their attending clinician and want to take~     part, they will be included. Participants will complete a number of standardised~     questionnaires and a demographics information sheet in the outpatients' clinic with the~     CI/RA present. The questionnaires include questions on psychological trauma history and~     symptomatology, general psychological distress, appearance related distress and perceived~     severity of condition. Clinical severity of their acne will be obtained from patient files~     after questionnaire completion by NHS staff. Participants will also be given a debrief~     letter and additional forms of support and information to take home with them. Participants~     will not be contacted for follow-up.~   "
56771|NCT02314026|"~     This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or~     without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with~     histological findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other~     liver diseases using the BreathID® System~   "
56772|NCT02314013|"~     The aim of the present study was to evaluate whether antibiotics is mandatory for the~     treatment of acute uncomplicated right-sided diverticulitis.~      The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided~     colon will be recovered without antibiotics.~   "
56773|NCT02314000|"~     To demonstrate sustained clinically significant pain relief in patients with chronic pain~     when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at~     sub‐perception amplitude~   "
56774|NCT02313987|"~     The current study is designed to test the hypothesis that compared to conventional~     treatment; endothelial function-guided treatment reduces adverse cardiovascular events in~     patients with non-obstructive coronary artery disease documented at clinically indicated~     coronary angiography.~   "
56775|NCT02313974|"~     At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been~     determined.~      Almost 30 percent of patients in total remission during or after a treatment, will relapse~     in the first 5 years.~      The factors associated to Renal relapses are not completly known. The investigators think~     that an histological control study performed to patient with complete remission for a year~     at the end of a 3 years treatment could help us to know which patients are going to relapse.~   "
56776|NCT02313961|"~     The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic~     conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary~     intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI)~     can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for~     heart failure (HF) for a minimum follow-up period of 12 months.~   "
56777|NCT02313935|"~     The study involved Information and Communication Technologies (ICT) and more specifically~     computer exercises blended with game activities. It was hypothesized that ICT facilitated,~     game blended cognitive and/or physical exercise improves global cognition when compared to~     control groups; moreover, these improvements may be manifested by brain activity changes; we~     explored the impact of potential moderators on combined exercise-induced cognitive benefits,~     as well as, individual/separate training schemes.~   "
56782|NCT02313870|"~     This controlled multi-center randomized clinical trial, with direct individual benefit, will~     compare efficacy and safety of two strategies in non-localized BP care: a combined regimen~     using initial superpotent topical steroids associated with methotrexate for 4 weeks followed~     by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9~     months (current standard of care). The expected result is an equivalence between the two~     compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance~     phase being easier to manage and therefore associated with better compliance than topical~     steroids with less cutaneous side effects and most cost-effective.~   "
56783|NCT02313857|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      CMV can cause serious infections in patients with weak or suppressed immune systems. It~     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,~     the liver and the eyes.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     CMV infections that occur after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach~     is not practical when a patient already has an infection.~      Investigators have now generated CMV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target CMV.~      In this study, investigators want to find out if the banked CMV-specific T cells derived~     from healthy donors are safe and can help to treat CMV infection.~      The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food~     and Drug Administration (FDA).~   "
56784|NCT02313844|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who~     have weak immune systems. It affects the urinary tract, and can cause frequent urination,~     blood in the urine, and severe pain.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     BKV infections that occur after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach~     is not practical when a patient already has an infection.~      Investigators have now generated BKV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target BKV.~      In this study, investigators want to find out if the banked BKV-specific T cells derived~     from healthy donors are safe and can help to treat BK virus infection.~      The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food~     and Drug Administration (FDA).~   "
56785|NCT02313831|"~     The purpose of this study is to investigate the effects of interval training,~     based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory~     anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate,~     metabolic profile in patients with and without coronary artery disease.~   "
56786|NCT02313818|"~     The primary goal of this study is to improve the overall efficacy of cognitive processing~     therapy-cognitive-only version (CPT-C) in a sample of 200 active-duty service members~     through a variable length treatment.~   "
56787|NCT02313805|"~     Diabetes prevalence continues to rise worldwide, leading to the increasing use of insulin.~     This especially applies to developing countries where the needle-and-syringe method of~     administration remains the most affordable and effective form of hyperglycemic treatment.~     Competent health care professionals are required to ensure safe insulin initiation. The~     investigators will evaluate a teaching intervention on insulin initiation for medical~     students, and whether after experiencing that intervention the use of a checklist, during~     simulate insulin initiation, improves the education they provide to patients.~   "
56788|NCT02313792|"~     The purpose of this study is to compare the efficacy and safety of palifermin on reducing~     mucositis for patients receiving autologous or allogeneic stem cell transplantation with~     supportive care.~   "
56789|NCT02313779|"~     The overarching goal of the proposed research is to investigate the role of emotions in~     facilitating successful lifestyle change, defined as healthy behavioral decisions repeated~     daily, or near daily.~      Participants are asked to make two lab visits during the course of four weeks to complete~     electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate,~     blood pressure, respiration), and listen to a guided meditation audio track. Additionally,~     between the two visits participants will be asked to complete weekly surveys that ask about~     daily meditation practice (outside of the lab) and general emotions.~   "
56790|NCT02313766|"~     Adults patients scheduled for elective surgery were randomly allocated to receive~     preoxygenation with spontaneous breathing, positive pressure ventilation (positive~     inspiratory pressure: 12 cmH2O) without PEEP, and with PEEP (positive inspiratory pressure:~     12 cmH2O, PEEP: 6 cmH2O). Preoxygenation time was measured from face mask positioning to~     FEO2=90% (FEO2 : expired fraction of O2). After endotracheal tube placement the time until~     SpO2=93% (SpO2 : peripheral oxygen saturation) was measured during monitored apnoea.~     Patient's discomfort was recorded (visual analogue scale).~   "
56791|NCT02313753|"~     The purpose of this study is to evaluate the utility of the Coping Long Term with Active~     Suicide Program (CLASP) for reducing suicidal behavior.~   "
57105|NCT02309645|"~     The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for~     suture-line sealing in dura-mater closure in elective or urgent paediatric cranial~     neurosurgery to provide intraoperative watertight closure.~   "
56795|NCT02313701|"~     The investigators aim is to augment the current process for surgical consent for patients~     undergoing urogynecological procedures by incorporating visual media. We propose that visual~     media will be an effective and efficient addition to the standard of care in~     urogynecological consents and will improve patient understanding and satisfaction. Our~     randomized controlled trial will investigate the effect of standardizing the consent for~     three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and~     sub-urethral sling) using visual media, on patients' understanding of, and satisfaction~     with, their procedure. Our primary outcome will be patient's knowledge score at the end of~     the pre-operative clinic visit, and secondary outcomes include patients' satisfaction,~     subjective understanding of their procedure, immediate pre-operative and post-operative~     knowledge, and number of post-operative encounters. Participants will be followed up to~     their post-operative clinic visit.~   "
56796|NCT02313688|"~     The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly~     during the past decades. By the Siewert classification, the AEJ is the tumor center located~     5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual~     subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ.~     The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal~     approach gastrectomy has better survival outcomes compared with left thoracoabdominal~     approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is~     recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines~     of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal~     resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is~     still controversies. Previous study found that longer than 2cm proximal resection margin had~     better survival outcome than less than 2cm proximal resection margin for Siewert-II/III~     tumors. On the other sides, due to more advanced tumor stage of patients in China when~     compared with Japan and Korea. It is necessary to conduct a randomized control study to~     analyze the length of resection margin in advanced adenocarcinomas of esophagogastric~     junction.~      Therefore, this study was aimed to include those Siewert II/III tumor patients in~     Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the~     relationship between the length of proximal resection margin and survival outcomes.~   "
56797|NCT02313675|"~     The purpose of this study is to determine the efficacy of intra-operative administration of~     IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients~     and distal radius fracture patients.~   "
56798|NCT02313662|"~     All patients planned for PDD guided TURB can be included in this study. Two different optics~     with PDD and NBI are applied to the resectoscope in addition to regular WL.~      First, a WL cystoscopy is made and any suspect areas are noted on the registration form,~     then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD~     with registration of any additional findings. To adjust for bias introduced by photo~     bleaching, the second part of the study will be performed with PDD as the second modality.~     Any flat lesions will be biopsied if they appear suspicious in one of the modalities.~      The registration form is completed by the surgeon, once the pathology results are known.~      A total number of 152 patients is planned to be included.~   "
56799|NCT02313649|"~     This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography~     (SWE) correspond with a biopsy result (currently the gold standard). The population that~     will be evaluated are Chinese patients infected with the Hepatitis B virus.~   "
56800|NCT02313636|"~     Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of~     the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy~     and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light~     sources.~      First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted.~     After WL, the cystoscopy is made with NBI and any potential subsequent change in the~     clinical decision is noted.~      A total number of 896 patients is planned to be included.~   "
56801|NCT02313623|"~     The investigators hypothesize that this single-cell analysis can be used to evaluate~     prostate needle-core biopsies prospectively even in non-homogenous samples by providing~     profiles of proteomic and phenotypic signatures. These profiles will in turn enable better~     predictions of the malignant progression of prostate cancers in the settings of current~     clinical practice.~   "
56802|NCT02313610|"~     The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan~     in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.~   "
56803|NCT02313597|"~     Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in~     100,000. Anal fistula is classified on the basis of its location into high and low anal~     fistula, above or below dentate line respectively.~      Multiple series have shown that the formation of a fistula tract following anorectal abscess~     occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the~     dentate line in the anal canal arranged circumstantially. These glands afford a path for~     infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states~     that an infection begins in the anal canal glands and progresses into the muscular wall of~     the anal sphincters to cause an anorectal abscess.~      According to internal opening many author proposed certain classification but the~     standardized in all of them is Park's classification, so this study categorized the patient~     through this classification. There are four types of fistula-in-ano in Park's Classification~     intersphincteric (between internal and external sphincters is 70%), transsphincteric (across~     external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above~     and through levator ani).High anal fistula is considered to be difficult to treat because of~     its location.This study diagnosed the internal opening of high perianal with the help of~     endoluminal ultrasound and MRI.~      Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these~     are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore~     many method have been recently devised including Ligation of intersphincteric fistula tract~     (Lift), glue repair and flap advancement.Another recently introduced method for its~     treatment is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has~     been associated with less complications.~   "
56804|NCT02313584|"~     The purpose of this study is to investigate the appropriate duration of dabigatran use after~     radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low~     thromboembolic risk. According to the most recent guideline, anticoagulation is recommended~     to continue at least 2 months after the procedure. However bleeding risk with anticoagulant~     is also problematic. Post-procedural thrombosis is considered due to acute inflammation or~     char formation at the site of ablation, and these reaction occurs mostly within 1 month~     after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc~     score less than 1. The investigators hypothesized that dabigatran use for the first 1 month~     after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be~     sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.~   "
56805|NCT02313571|"~     The computer-integrated patient controlled epidural analgesia (CIPCEA) system can~     automatically adjust the background infusion rate during combined spinal-epidural (CSE)~     analgesia based on the parturient's need as labour progresses. Analysis of parturients~     experiencing breakthrough pain may identify associated factors that can also be related to~     obstetric or foetal outcomes~   "
56806|NCT02313558|"~     The objective of the present study was to compare the anti-plaque and anti-gingivitis~     effects of a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex~     extract to those of a control dentifrice without any active ingredient in 12 weeks of home~     use.~   "
56807|NCT02313545|"~     In this open label study, 50 eligible women will be assigned to receive the investigational~     product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for~     the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at~     baseline and after 2 and 6 weeks of treatment.~      The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the~     treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).~   "
56808|NCT02313532|"~     Study goal - to describe pediatric patients with febrile disease that administered to the~     emergency department (ED) of hillel-yaffe hospital, according to arrival diagnosis, ED~     diagnosis, given therapy, and therapy concordance with the guidelines and final diagnosis.~      This research will describe cases that arrived to the hospital with acute febrile disease~     (up to seven days of fever), the antibiotic treatment given in the community according to~     the anamnesis and the community physician letter, therapy concordance with the guidelines,~     the ED diagnosis and changes in therapy, and final diagnosis according to extended~     microbiological examinations and panel of infectious disease specialists.~   "
56809|NCT02313519|"~     Based on the need of large-scale, trials to explore the use of probiotics to reduce~     post-operative complication rate, a randomized controlled trial is designed to investigate~     the impact of a probiotics treatment protocol on postoperative morbidity in an open elective~     colonic surgery cohort. The major objective is reduction of post-operative complications~     after 30 days.~   "
56810|NCT02313506|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of~     150 minutes or more per week. The primary goal of this pilot randomized controlled trail is~     to assess the feasibility and preliminary efficacy of a multi-component intervention/model~     of care involving a group education session, use of the Fitbit Flex (a wireless physical~     activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to~     improve physical activity and reduce sedentary time in patients with knee OA.~   "
56811|NCT02313493|"~     In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal~     parent training- are investigated. Healthy becoming first time parents were randomly~     allocated to either the Baby Triple P parent-training group or a care as usual control~     group. It is expected that 78 couples of becoming first time parents are recruited. It is~     hypothesized that parents and their infants in the parent training group will show~     significantly less psychopathology / regulation problems and better partnership quality than~     participants in the control condition.~   "
56812|NCT02313480|"~     To date, the benefits of massage in chronic neck pain patients has only been investigated as~     a singular treatment, rather than as part of a treatment package. The need for this research~     has been highlighted in the literature (Ezzo et al, 2007; Haraldsson et al, 2006) This~     research aimed to establish whether the addition of massage to a program of exercise and~     manual therapy offers any additional benefits over exercise and manual therapy alone in the~     treatment of patients with chronic neck pain.~   "
56813|NCT02313467|"~     In this study, the investigators are going to compare the clinical effect and safety of~     topical application of 1.5% Butenyl ALA cream formula without light source irradiation in~     the treatment of acne.~   "
56814|NCT02313441|"~     Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary~     intervention (PCI) and is associated with subsequent cardiovascular events. This study~     assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in~     patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients~     received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg~     around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the~     PCI procedure, and the control group (n = 100).~   "
56815|NCT02313428|"~     This study is to observe the effect of application of topically administered oxygen on~     healing rate, cost of care and rate of amputations in diabetic patients with foot ulcer(s)~     (DFU). The proposed study is a pragmatic (comparative effectiveness research, CER) study, in~     which the effectiveness of topical oxygen (100%) administered 4 days per week, for 16 weeks,~     for the treatment of diabetic foot ulcer (DFU) will be measure and compared with standard of~     care (SoC) treatment. There will be a 2 patient groups (including a comparison groups and a~     treatment groups) including: (1) Medicaid patients who are at Wagner grade 2 and below, will~     only receive standard treatment (2) Medicaid patients who are at Wagner grade 2 and below,~     will receive standard treatment plus Topical Oxygen Therapy. All of the Topical Oxygen~     Therapy will be provided in a home care setting or extended care facility.100 patients will~     be recruited.~      This study is to assist the Ohio Department of Medicaid (ODM) and to provide efficient and~     effective administration of the Medicaid program.~      This is an observational and descriptive study that will seek to generate a hypothesis. Due~     to the small sample size this study will primarily be a feasibility study that will attempt~     to measure and evaluate differences in the relative costs of the intervention of topical~     oxygen therapy on this population and subsequently compare outcomes in areas such as overall~     health improvements and cost effectiveness. The patient population will consist of Medicaid~     beneficiaries with DFU at Wagner grades 2 and below who are enrolled in the United Health~     Care Community Plan of Ohio (UHC).~   "
56816|NCT02313415|"~     Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial~     dysplasia by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem~     cells, and to provide clinical evidence for the treatment of uterine infertility.~   "
57128|NCT02309346|"~     Septic abortion is a serious condition. Women with septic abortion are treated with~     clindamycin plus gentamicin using divided doses, i.e., thrice a day.~      The objective of this study is to compare the rates of cure between once or thrice a day use~     of clindamycin with gentamicin in cases of septic abortion.~   "
56817|NCT02313402|"~     Eighteen ALS patients will be trained to control a new communication device (Eye On Line:~     EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at~     will. The intervention consists in a training program during six visits over 3 weeks on site~     allowing a gradual acquisition of the eye-writing. The primary objective of the study is to~     assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially~     offers a creative and personal means of linguistic and emotional expression in subject with~     motor disability.~   "
56818|NCT02313389|"~     Hypothesis~      Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained~     after a standard induction chemotherapy with an acceptable toxicity in the elderly.~      Rationale~        -  Treatment of the elderly is challenging, indeed age over 60 is associated both with a~          poor prognosis and a high risk of treatment induced neurotoxicity with devastating~          consequences on quality of life. Therefore it has become standard practice to treat~          elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone,~          avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.~        -  There is a clear need to improve disease control after induction chemotherapy. Since~          consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are~          either poorly effective and/or too toxic in the elderly population, maintenance~          chemotherapy is an interesting alternative approach. Several agents, such as high-dose~          MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable~          safety profile, as single agent or combined, are good candidates for maintenance~   "
56819|NCT02313376|"~     Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum~     (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also~     confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary~     objectives are to evaluate the humoral immune responses to GAP3KO.~   "
56820|NCT02313363|"~     The investigators developed a patient-centered smartphone-based diabetes care system~     (PSDCS). This study was aimed to test the feasibility of the PSDCS.~   "
56821|NCT02313350|"~     Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is~     the gold-standard and the only controlled treatment in case of failure of conservative~     treatment.~      Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.~      In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which~     may avoid 2% complications after disc surgery and 5% repeated surgery (according to recent~     trials).~      This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery~     in patients with sciatica due to lumbar disc herniation and unresponsive to conservative~     medical treatments (including epidural steroid injections) Our expectation is that Discogel®~     chemonucleolysis will avoid surgery in 80% of the patients.~   "
56822|NCT02313337|"~     The study purpose is to compare the effect of different Administration Routes of Pediatric~     Premedication (including oral administration, intramuscular injection, rectal perfusion,~     intranasal).~   "
56823|NCT02313324|"~     The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy~     (ESWT) on the outcomes of coccydynia.~   "
56824|NCT02313311|"~     The objective of this study is to establish a hierarchical embryo selection process by using~     the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.~   "
56825|NCT02313298|"~     A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late~     toxicity and secondarily PSA outcomes and quality of life measurements of an extreme~     hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.~   "
56826|NCT02313285|"~     Primary Objective:~      To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who~     received prior treatment during the TDU13475 or TDU14981 studies.~      Secondary Objectives:~      To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the~     pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668~     in patients with MS.~   "
56827|NCT02313272|"~     The purpose of this study is to see if the addition of the investigation drug called~     pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can~     help with controlling the growth of tumors, in participants with recurrent high grade~     glioma.~   "
56828|NCT02313259|"~     The purpose of the study was (1) to determine thresholds for discriminating speed in~     peripheral fields of patients with dry AMD and (2) to examine the driving skills of licensed~     drivers with early dry AMD using a driving simulator and to investigate how their healthy~     counterparts perform on the same driving tasks. We hypothesized that speed discrimination~     may be better in patients with dry AMD than in healthy control subjects.~   "
56829|NCT02313246|"~     This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable~     Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and~     normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour~     therapy for IBS within 1 month of being deemed eligible for the study.~   "
56830|NCT02313233|"~     To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to~     the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of~     Umooze twice daily administration for 56 days in patients with BPH.~   "
56841|NCT02313090|"~     The aim was to assess the impact of a cell phone-based diabetes management application~     (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure~     during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang,~     their diabetes knowledge and self-care behaviors were also evaluated.~   "
56842|NCT02313077|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.~   "
56843|NCT02313064|"~     This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main~     purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK)~     of CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy~     volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part~     B).~   "
57142|NCT02309164|"~     This study aims to determine the effectiveness of the use of acupuncture in relieving~     sensory and motor symptoms as well as functional impairment and quality of life of patients~     with chemotherapy induced peripheral neuropathy~   "
56831|NCT02313220|"~     Obesity is a medical condition which increases the risk of other diseases, such as type 2~     diabetes and cardiovascular disease. Obesity-related risk factors for the development of~     other metabolic diseases include unstable glucose levels and high blood pressure.~     Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type~     2 Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal~     reabsorption of glucose and thereby promoting its urinary excretion and energy loss and~     thereby reduction in body fat. Exenatide exhibits many of the same glucose-lowering actions~     of that of a naturally occurring hormone and leads to weight loss mainly via reduced energy~     intake, most likely via a central effect on appetite regulation. The purpose of this~     exploratory study is to investigate if a combination treatment with dapagliflozin and~     exenatide have a synergistic effect on weight loss in non-diabetic obese subjects. Subjects~     will be treated for 24 weeks with either active combination treatment or placebo (non-active~     treatment). Neither study personnel nor subjects will know what treatment is given. All~     subjects completing the 24-week double-blind study and who are willing and eligible will be~     offered to enter a 28-week open-label extension study. All subjects entering the extension~     study will receive unblinded active study treatment for an additional 28 weeks. Thus the~     total treatment period for subjects entering the extension study will be 52 weeks.~   "
56832|NCT02313207|"~     This study will assess dynamic effects of two major antigens on the duodenal mucosa by~     confocal laser endomicroscopy (CLE). Patients will be blinded to the antigens used (wheat,~     yeast). Following CLE it is planned to have a cross over exclusion diet with/without the~     antigens including a washout phase. Furthermore, patients will undergo a 2 week FODMAP diet~     to be able to compare results found of both diets and allow to understand whether our~     findings of food intolerance will be better and more precise than a common FODMAP diet.~      Post CLE food challenge patients biopsies will be taken for histology. They will then be~     randomized into two groups and blinded to the diet they undergo. They will be provided with~     a supply of custom-made bread they will have for 2 weeks (custom made by a bakery in Kiel).~     For one study arm bread will contain either wheat and yeast, for the other arm the bread~     will not contain these ingredients. The taste of the normal bread will be denaturised.~     Crossover will take place after a two-week washout phase.~   "
56833|NCT02313194|"~     This study is designed to assess the strategy of using spinal cord stimulation to improve~     the ability to move in spinal cord injured humans.~   "
56834|NCT02313181|"~     This is a randomized, controlled trial designed to evaluate a new strategy for promoting~     continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn~     period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula~     fed to each baby by syringe after each breastfeeding prior to the onset of mature milk~     production. The study intervention is discontinued at the onset of mature milk production,~     and the investigators will then follow mothers and infants for 12 months to assess the~     effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.~   "
56835|NCT02313168|"~     The F.R.O.N.T. formula for pre-operative airway assessment and documentation~      Background:~      Prediction of difficult airway is one of the most important challenges before general~     anesthesia. Although in recent decades different scoring systems have been for the~     preoperative assessment of their sensitivity and specificity in predicting a difficult~     airway remains moderate. Recently, the calculation of composite scores using different~     formulae has been proposed as the most sensitive one. The aim of the present work was to~     test the clinical usefulness of the FRONT score, a recently developed scoring system.~      Methods:~      This study was a multi-center, inter-observer, prospective and double-blind investigation~     that included 976 patients from two university centers: 250 from the University of~     Cluj-Napoca, Romania, and 726 from the University of Debrecen, Hungary.~      The preoperative evaluation of the patients was performed by a preoperative team of~     anesthesiologists (team A) who evaluated and scored the expected difficulty of the~     management of the airway. An intraoperative team of evaluators (team B) working~     independently from team A, performed the actual instrumentation of the airway and scored the~     actual findings. Both teams used the FRONT scoring system and worked independently from each~     other to ensure blinded assessment. Statistical analysis of the preoperative and~     intraoperative FRONT scores were performed post hoc.~   "
56836|NCT02313155|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single~     subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in~     healthy Japanese adults~   "
56837|NCT02313142|"~     One of the major issues in space explorations is the negative effect of prolonged exposure~     to very low gravity (i.e. a condition often referred to as microgravity or weightlessness)~     on astronauts' health. In this unusual condition the human body undergoes an adaptation~     process, often referred to as deconditioning, that leads to significant loss of bone and~     muscle mass, hormonal changes, as well as modifications of important cardiovascular~     parameters. While the new physiological state is adequate to the microgravity environment,~     it results unsuitable upon return on earth. Hence after the mission astronauts experience~     various health-related problems and must undertake an intense rehabilitation program.~     Cardiovascular deconditioning originates mainly from a shift of blood from the lower~     extremities to the upper part of the body caused by the absence of gravity. In the long term~     (i.e. days) this causes a loss of blood and body fluid. In the short term (i.e. minutes) it~     elicits modifications to arterial blood pressure and heart rate.~      In this study, funded by the European Union through the project STAMAS, we intend to~     evaluate whether leg physical exercises can lead to a displacement of blood towards the~     lower extremities, therefore ameliorating the upward fluid shift caused by weightlessness.~     More generally, we aim to investigate the short-term response of the cardiovascular system~     to leg exercises in microgravity-like conditions. After a clear understanding of these~     phenomena we will develop a controller that, by monitoring the physiological stare of a~     subject, will compute the appropriate exercise regime to stabilize his/her cardiovascular~     parameters to desired safe values. Our contribution will provide a better understanding of~     the cardiovascular system, and will delineate the physiological ground for the development~     of novel countermeasure devices against the cardiovascular deconditioning during space~     flight based on continuous leg exercises.~      The protocol we propose in this document presents minimal risks for our potential subjects,~     while has the potential to produce important contributions. The cardiovascular parameters we~     intend to analyse are: blood pressure, heart rate and leg blood volume. These signals will~     be acquired non-invasively and with minimal risks. Leg exercises will be performed by means~     of a stepping device (MARCOS) previously developed in our Lab. MARCOS enables to vary the~     resistance applied against knee-extension movements, and therefore it allows a systematic~     evaluation of different exercise intensities. Finally, microgravity conditions can be easily~     emulated by letting the subjects lay on a tilted platform with head-down (i.e. head-down bed~     rest - HDBR, or head-down tilt - HDT) during the exercise sessions, thus inducing a shift of~     body fluid toward the thorax. The most effective inclination angle has proved to be as low~     as -6°, thus constituting only minimal risks for the subjects. In practice, subjects will~     comfortably lay on the negatively tilted platform and will perform stepping at different~     intensities while their cardiovascular parameters are being monitored and recorded in~     encrypted form for subsequent analysis.~   "
56838|NCT02313129|"~     The purpose of this study is to increase our understanding of infertility in women with~     Rheumatoid Arthritis (RA). In this study the study team will compare the differences in~     ovarian reserve (the ability to provide egg cells that are capable of fertilization), the~     frequency of ovulation and the number of pregnancies between women with and without RA. It~     is possible that RA activity and medications limit ovarian reserve and ovulation, which may~     increase infertility among women with RA. There are several suspected causes for infertility~     in RA, including age-related fertility decline, inflammatory changes that impact endometrial~     receptivity and discourage implantation, accelerated ovarian decline due to certain~     arthritis medications and increased frequency of anovulation (a menstrual cycle during which~     ovaries do not release an egg) due to RA activity.~      This study is the first step toward our long term goal of increasing the ability of all~     women with RA to build the family they desire.~   "
56839|NCT02313116|"~     This intraoperative study is a prospective study analyzing specimens from fifty subjects.~     Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with~     the inclusion and exclusion criteria. The study period per subject is the time it takes to~     assess the ex vivo breast tissue sample using the study device. Image review will be~     conducted during surgery and compared to the margin status findings in the post-operative~     pathology report.~   "
56840|NCT02313103|"~     This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult~     subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with~     normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender,~     age, and BMI.~   "
57155|NCT02308995|"~     The aim of this randomized controlled trial is to compare operative data and early~     postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with~     those of laparoscopic excision of endometrioma using conventional sutures.~   "
56844|NCT02313051|"~     Everolimus has been approved to be effective when used with exemestane after progression on~     non-steroidal aromatase inhibitors in postmenopausal women based on the BOLERO-2 clinical~     trial. However, the superiority of addition of everolimus to endocrine therapy hasn't been~     established in the premenopausal women. This is a phase 2, multicentre clinical trial to~     evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC~     patients after progression on tamoxifen.~   "
56845|NCT02313038|"~     Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug~     eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive~     and of high cost, however the knowledge about the real-life DES use and the efficacy and~     safety in China is limited. By consecutively recruiting first-ever PCI patients in 30~     geographically representative highest-rank hospitals, this study will examine the prognosis~     in groups with different brands of DES, and various real-life factors, that may affect~     patients recovery after the procedure. Evidence for clinical practice and health resource~     allocation will be established based on the findings, to improve patients outcomes in future~     finally.~   "
56846|NCT02313025|"~     The language intervention 'Kaatje Klank' is designed for stimulating the speech production~     and speech perception skills of 4-year-olds in an early childhood educational setting, in~     order to stimulate early literacy skills. These skills are crucial skills for technical~     reading in later ages. Good reading skills are an important condition for academic success.~      To measure the effect of the language intervention 'Kaatje Klank', the intervention will be~     applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50%~     non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a~     coaching trajectory.To measure the effect on speech production and perception skills, a pre-~     and posttest and a comparison with a matched control group (n = 100 children, 50% native~     speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a~     different language intervention which focuses on vocabulary development (World-project).~   "
56847|NCT02313012|"~     The CC-90003-ST -001 trial is a first-in-man, open-label study in subjects with~     locally-advanced or wide spread cancers to determine if CC-90003 (an oral medication) can be~     adequately tolerated with minimal side effects.~   "
56848|NCT02312999|"~     Study goal: This study will examine whether there is a significant difference in~     postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.~      Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance~     with a balanced starch solution (volulyte®) will be associated with a decrease in~     postoperative complications compared to the same approach using a balanced crystalloid~     solution (Plasmalyte®).~      Objective: To establish which kind of intravenous fluid used for goal directed therapy with~     closed-loop assistance will reduce the number of postoperative complications (evaluation~     made by the POMS score).~   "
56849|NCT02312986|"~     This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to~     suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with~     recurrent MDRO infections due to organisms of likely enteric origin.~      FMT will be performed on subjects with a history of at least three recurrent infections due~     to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or~     at least two recurrent infections due to MDRO for which only antimicrobials with rate~     limiting toxicities are available.~      The objective of this protocol is to determine if fecal microbiota transplantation (FMT)~     will be able to prevent additional recurrences of infections due to MDRO by suppressing or~     reversing enteric colonization with MDRO.~   "
56850|NCT02312973|"~     The study investigates the pharmacokinetics (absorption, distribution, elimination) of~     molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring~     hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In~     addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well~     as the safety and tolerability of molidustat.~   "
56851|NCT02312960|"~     Patients will be followed up in this study after prior treatment with BAY 88-8223 /~     Radium-223 dichloride / Xofigo .~   "
56852|NCT02312947|"~     Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold~     dissection adenoidectomy specifically inquire which method is safer and more efficient.~   "
56853|NCT02312934|"~     The purpose of this study is to evaluate the use of a nicotine patch as a treatment for~     problems with attention, learning and memory in breast cancer patients who are 1-5 years~     post chemotherapy.~   "
56854|NCT02312921|"~     The main goal of the payment and delivery system reform is to reduce disparities in oral~     health and dental care access of low-income mothers and children living in rural Oregon~     counties. The target population is children, pregnant women and new mothers enrolled in~     Oregon Health Plan (OHP) in rural Oregon.~   "
56855|NCT02312908|"~     The purpose of this study is to determine whether clonazepam is effective and safe in the~     treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease~     (PD).~   "
56856|NCT02312895|"~     This is a comparative study to determine if there is a difference in pain reduction and~     disability between dry needling and manual therapy for patients with low back pain. Subjects~     will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling~     or manual mobilizations along with patient education and a home exercise program.~   "
56857|NCT02312882|"~     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus~     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia~     areata and its variants.~   "
56868|NCT02312739|"~     This is a randomized, double blind study that aims to measure the difference in maximum pain~     experienced during in-office transcervical sterilization (Essure®) for women receiving~     either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled~     oxygen.~      The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced~     more than standard oral medications in women undergoing in-office transcervical~     sterilization.~   "
57084|NCT02309918|"~     This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and~     safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV~     infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90~     mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.~   "
56858|NCT02312869|"~     In the general intensive care unit (ICU) population, there is strong evidence for benefit~     from lung-protective mechanical ventilation, including the use of low tidal volumes and~     adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly~     uncertain whether these settings are beneficial and there are even concerns over safety of,~     in particular use of low tidal volumes. There is lack of international guidelines and~     consequently ventilation practice in burn patients may widely vary.~      The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing~     on the size of tidal volumes and the levels of PEEP used for burn patients. In addition,~     data on other strategies considered important in patients who receive ventilation are also~     collected, including data on neuromuscular blocking agents, sedatives and analgesics, and~     type and amount of intravenous fluids used in the period of ventilation. The secondary~     objective is to determine the association between tidal volume size and levels of PEEP, and~     duration of ventilation in burn patients.~   "
56859|NCT02312856|"~     This study is designed to evaluate the safety of the PulseRider in patients undergoing~     treatment for bifurcation basilar or carotid terminus aneurysms.~   "
56860|NCT02312843|"~     The purpose of this research study is to examine the effects of high and low intensity~     exercise for those with mild memory loss and pre-diabetes. The investigators will also~     examine the effects of this exercise on certain proteins and hormones in body fluids, and on~     brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate~     that exercise improves memory and thinking abilities for adults with mild memory loss OR~     pre-diabetes. This study examines the effects of exercise on people with mild memory loss~     AND pre-diabetes.~   "
56861|NCT02312830|"~     With the increasing successful use of allogeneic hematopoietic stem cell transplantation~     (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the~     long-term effects of such a drastic treatment.~      This study investigates the prevalence of several demographic, psychosocial and behavioral~     aspects of survivorship after an allogeneic transplantation. Income, return to work, social~     isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking~     habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional~     status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality~     and resilience will be studied.~   "
56862|NCT02312817|"~     Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US~     and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5~     high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low~     socioeconomic status patients receiving care through safety-net health systems. Screening~     and follow-up failures lead to more advanced cancers, when curative therapies are not~     available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced~     stages, due to poor recognition of high-risk patients, underuse of screening among these~     patients, and poor follow-up of abnormal screening tests. To address these barriers, the~     investigators propose to conduct a comparative effectiveness research randomized controlled~     trial of three screening strategies among a socioeconomically disadvantaged and racially~     diverse cohort of cirrhotic patients at high risk for developing HCC.~      Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be~     randomized to:~        -  Group 1: Usual care, with visit-based HCC screening per discretion of individual~          providers~        -  Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource~          intensity)~        -  Group 3: Mailed HCC screening invitation outreach to eligible patients combined with~          centralized patient navigation to promote screening completion and follow-up (high~          resource intensity)~      Through three specific aims, this effectiveness research randomized controlled trial will:~        -  Aim 1: Engage stakeholders in design and implementation of HCC screening outreach~          interventions.~        -  Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention~          strategies to increase completion of one-time and repeat HCC screening.~        -  Aim 3: Evaluate whether intervention effects are moderated by patient sex, race,~          ethnicity, English proficiency, and connectedness to primary care.~      The screening intervention strategies combine EMR-enabled case identification, system-level~     screening outreach, and patient navigation to improve identification of previously~     unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up~     of abnormal screening tests. This study will engage stakeholders throughout the research~     process, evaluate the effectiveness and acceptability of HCC screening strategies, and~     determine which patient subgroups benefit the most.~   "
56863|NCT02312804|"~     This study will be conducted using 3+3 design and includes, a dose escalation part to define~     the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion~     part to treat another 12 patients (only cervix cancer) to further evaluate safety of this~     combination. Safety, tolerability and MTD will be determined in the dose escalation part of~     the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy~     in cervical cancer. The dosing cycle is 21 days.~   "
56864|NCT02312791|"~     Understanding patient's prognosis is of utmost importance to determine radiotherapy's~     indication and dose/ fractionation. The investigators plan to conduct an observational study~     of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital~     in Brazil.~   "
56865|NCT02312778|"~     Non-specific low back pain is defined as a pain with no specific vertebral-related cause,~     such as infectious disease, tumor, osteoporosis, fracture, structural abnormality,~     inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific~     low back pain is a common disease in many countries. This musculoskeletal disorder is costly~     to public health systems. Therefore, the use of manual therapies is important in the~     treatment of this disease and studies show the effectiveness of this type of therapy.~      Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and~     Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There~     is moderate evidence that spinal manipulation is superior to sham spinal manipulation for~     improving short-term pain and function in chronic and acute non-specific low back pain.~     However the therapeutic mechanisms involved in this procedure are not well understood.~     Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be~     effective in reducing pain and improving functional capacity in subjects with non-specific~     low back pain, the effect on postural variables have not been investigated. Therefore, the~     aim of this study is to evaluate the acute effect of lumbar manipulation on pain and~     postural variables.~      Twenty-four individuals with non-specific low back pain will be randomly allocated to two~     groups. The intervention group will receive high velocity and low amplitude spinal therapy,~     while the control group will receive sham manipulation. Immediately before and after the~     respective manipulation protocol, both groups will be evaluated regarding pain level, using~     a visual-analogue scale and algometer, and postural variables, using center of pressure~     displacement measured with the aid of a force plate. While the patient and therapist~     manipulator will be aware of the protocol applied in each case, the evaluator will be blind.~     A statistical treatment will be used to compare the results.~   "
56866|NCT02312765|"~     Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients~     with heart failure. Helping patients to effectively use the most common form of treatment~     for sleep apnea, positive airway pressure therapy, can improve their heart function. This~     can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs~     has developed an innovative solution that allows patients to communicate with health care~     providers 24 hours a day, thus allowing them to get the help they need to effectively use~     positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.~   "
56867|NCT02312752|"~     The purpose of the study is to determine whether a particular type of nerve fibers, A-delta~     fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy~     volunteers will be enrolled in this study.~   "
56869|NCT02312726|"~     The primary objective of this mixed methods pilot study is to understand women's experiences~     with postplacental intrauterine device (IUD) insertion through postpartum semi-structured~     interviews. For secondary objectives, the investigators will collect visual analog scale~     (VAS) and verbal rating score (VRS) data on women's pain experienced just before and~     immediately after IUD insertion. The investigators will perform postpartum interviews in~     each group until we reach thematic saturation. The investigators will recruit at least 60~     women (30 each in the epidural and no epidural group) from the University of New Mexico~     Hospital (UNMH) affiliated antenatal clinics to conduct our quantitative data analysis.~   "
56870|NCT02312713|"~     The purpose of this study is to examine the effectiveness of standard physical therapy and~     an internet-based exercise program for people with knee osteoarthritis (OA). Both of these~     programs will be compared to a waiting list control group. The investigators hypothesize~     that both treatments will result in greater improvement than the control condition and that~     the treatments will be similarly effective. The investigators also expect that some patients~     may do better with one treatment type or another and will explore this.~   "
56871|NCT02312700|"~     The study is aimed to verify the effect of an online interactive tool on patient~     empowerment. The tool is based on a validated psychological questionnaire administrated to~     breast cancer patients before their first encounter with physician.~   "
56872|NCT02312687|"~     UX023-CL203 is a Phase 2b, open-label, long-term extension study. The study will be~     conducted in adults to assess the safety and pharmacodynamics of KRN23 administered via~     subcutaneous injections monthly (every 4 weeks) for a total of 68 weeks. The study will~     enroll approximately 25 adults with XLH who participated in Kyowa Hakko Kirin Pharma, Inc.'s~     (KHK's) study KRN23-INT-001 or KRN23-INT-002. Subjects will need to discontinue oral~     phosphate and vitamin D metabolite therapy prior to enrollment and throughout the duration~     of the study.~   "
56873|NCT02312674|"~     The aim of the randomized controlled study is to determine effects of an adjusted amount of~     oral nutritional supplements on the quality of life, the nutritional status, side effects,~     and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving~     palliative therapy.~   "
56874|NCT02312661|"~     Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway~     and/or circumvent p53 in the induction of apoptosis are exciting potential targets in~     ovarian cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes~     mellitus, that has shown anti-cancer activity in preclinical studies. The main mechanism of~     metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to~     circumvent p53-induced apoptosis making it an exciting, potentially effective drug in~     ovarian cancer.~   "
56875|NCT02312648|"~     The objective of this study is to investigate the effects of a program of early mobilization~     in the functional capacity in patients undergoing coronary artery bypass grafting in short~     and long- term.~   "
56876|NCT02312635|"~     Traumatic Brain Injury (TBI) is the most common cause of death and long-term disability in~     children. Much of the long-term disability stems from neurocognitive impairments that are~     not greatly helped by current cognitive training and pharmacological treatments for TBI~     related cognitive impairments. This study tests the hypothesis that a drug, D-cycloserine~     (DCS), will significantly enhance the effect of cognitive training in correcting cognitive~     impairments in children with moderate/severe TBIs.~      In order to do so, study subjects who fit inclusion criteria, including those with moderate~     to severe TBI who show persistent working memory weaknesses based on a screening, will be~     recruited. They will have three visits to UCLA. During the first visit, subjects will~     undergo an MRI protocol before and after taking a pill (drug or placebo, blinded). They will~     also participate in a number of paper and pencil cognitive tests. Then subjects will be~     enrolled in a 6 week computerized cognitive training program (CogMed). They will also be~     prescribed a drug/placebo pill (depending on which group they are randomized into), which~     they'll have to take at regular intervals during the 6 weeks. They will have weekly check in~     phone calls or visits by a coach trained in the program to make sure they are following the~     study protocol accurately, to have their questions answered, and for motivation. At the end~     of the training period, subjects will return to UCLA to again complete the MRI protocol and~     cognitive testing. After three months of enrollment, they will have a final visit to UCLA,~     including only cognitive testing. A total of 30 subjects will be entered into the study.~   "
56877|NCT02312622|"~     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating~     patients with non-small cell lung cancer, small cell lung cancer, or breast cancer that has~     spread to the brain and does not respond to treatment. Pegylated irinotecan NKTR 102 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
56878|NCT02312609|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline~     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with~     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC~     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,~     adult, human, male subjects under fed conditions.~   "
56879|NCT02312596|"~     A prospective, randomized, controlled, clinical study to establish clinical based evidence~     of Eclipse PRP™ and compare its performance with the usual and customary practice for the~     treatment of Wagner 1 or 2 DFUs.~   "
56880|NCT02312583|"~     iFighDepression is an online self-help programme based on cognitive-behavioral therapy that~     could be useful for the treatment of mild to moderate depression~   "
56881|NCT02312570|"~     To assess the efficacy of the Eclipse PRP™ Wound Biomatrix and compare its performance with~     usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).~   "
56882|NCT02312557|"~     This phase II trial studies how well pembrolizumab works in treating patients with prostate~     cancer that has spread to other places in the body and keeps growing even when the amount of~     testosterone in the body is reduced to very low levels despite previous treatment with~     enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in~     different ways by targeting certain cells.~   "
57085|NCT02309905|"~     The purpose of this study is to determine whether Tele-expertise would be effective and~     cost-effective by reducing the number of secure transportations for inmates in need of a~     dermatological consultation~   "
56883|NCT02312544|"~     To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost~     drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic~     Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension.~     The study is designed to assess clinically meaningful response to treatment and is not~     powered to measure any efficacy endpoints with statistical significance.~   "
56884|NCT02312531|"~     In this study, HBV-infected pregnant women were divided into two groups, those who received~     and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the~     mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B~     surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were~     investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed~     both the level and distribution of HBIG in placentas. The protective mechanism of HBIG~     administrated during pregnancy was explored.~   "
56885|NCT02312518|"~     To assess the efficacy of the Eclipse PRP™ Wound Biomatrix and compare its performance with~     usual and customary practice for the treatment of chronic non-healing venous leg ulcers~     (VLU).~   "
56886|NCT02312505|"~     The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output~     monitoring system in patients undergoing elective cardiac surgery. The investigators~     hypothesize that the semi-invasive device may be affected by mean arterial pressure and~     systemic vascular resistance.~   "
56887|NCT02312492|"~     Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of~     labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after~     habituation to diets enriched in the corresponding fatty acid.~      Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be~     characterized by similar transport, higher conversion, and similar oxidation rates..~   "
56888|NCT02312479|"~     A prospective open-label, single treatment study to assess the safety and the performance of~     the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea~   "
56889|NCT02312466|"~     The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the~     authorities regarding iodine content in iodized salt. As a proxy for the entire population~     the investigators will study school aged children, pregnant women and women of reproduction~     age.~   "
56890|NCT02312453|"~     Abstract~      Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its~     course proximally, giving rise to impaired needle visualisation due to the steep angle of~     needle insertion with the current ultrasound-guided approach. A new posterior parasagittal~     in-plane ultrasound-guided infraclavicular approach was introduced to improve needle~     visibility. However no further follow up study was done.~      Methods: We performed a case series and a cadaveric dissection to assess its feasibility in~     a single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November~     2012 to October 2013. After obtaining approval from the Medical Ethics Committee, University~     Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively~     recruited. A cadaveric dissection was also performed. The endpoints of this study were the~     success rate, performance time, total anaesthesia related time, quality of anaesthesia and~     any incidence of complications.~   "
56891|NCT02312440|"~     Recently, there has been interest in applying tranexamic acid topically before the closure~     of surgical wounds in total hip replacement. It has the advantages of ease of application,~     maximum concentration at the site of bleeding, minimising its systematic absorption and,~     potentially , decline the risks for systematic side-effects 。~   "
56892|NCT02312427|"~     We thought to investigate the influence of DPP-4 inhibitor on the serum BNP level of~     diabetic patients with congestive heart failure. This study consists of two protocols. In~     the first protocol, diabetic patients with high level of serum BNP (100-2000 pg/ml)~     receiving outpatient treatment with any type of DPP-4 inhibitor at our institution will be~     enrolled. After baseline data collection, DPP-4 inhibitor will be suspended for one month~     and serum BNP will be measured. The DPP-4 inhibitor will be resumed and after another month,~     serum BNP will be measured again. In the other protocol, diabetic patients who were~     hospitalized due to heart failure were enrolled. DPP-4 inhibitor will be started after~     stabilization of heart failure, and serum BNP will be measured before and after the drug~     administration.~   "
56893|NCT02312414|"~     Anemia is a common disorder in CKD patients. It is largely attributed to decreased~     erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy~     includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp)~     protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There~     are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So~     far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress~     in CKD patients.~      In this proposed study we wished to examine whether Hp genotype influences intravenous iron~     administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the~     response of these patients to L-Carnitine therapy.~   "
56894|NCT02312401|"~     The purpose of this study is to better understand prostate cancer changes after radiation~     treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows~     doctors to see prostate gland without any operation procedures. It can help identifying the~     tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help~     doctors manage treatment better and sooner.~   "
56895|NCT02312388|"~     The purpose of this study is to compare the differences in central venous catheter insertion~     time, success rate, and complication between thin-wall needle technique and~     catheter-over-the-needle technique for central venous catheterization in children.~   "
56896|NCT02312375|"~     This study was designed to evaluate the effect of ARB in improving insulin secretion in~     patients with type 2 diabetes. The investigators also aimed to evaluate if there are~     potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and~     urinary albumin secretion in diabetic patients.~   "
56897|NCT02312362|"~     Objective:~      To compare intraocular pressure lowering effect of combined sclerotomy ab interno with~     phacoemulsification and phacoemulsification alone, in primary or secondary open angle~     glaucoma patients.~      Study design:~      Prospective, randomized, case- control interventional surgical trial~   "
56898|NCT02312349|"~     Celiac disease (CD) is a chronic autoimmune disorder in genetically susceptible individuals~     characterized by inflammation of the small intestine due to gluten intolerance. This protein~     is found in cereals such as wheat, barley and rye. In Argentina, oats are also considered a~     toxic grain since are as highly contaminated as the previous three. For this reason, the~     acronym TACC (Trigo, avena, cebada y centono: wheat, oats, barley and centono) is used for~     their identification. An effective treatment for celiac disease consists in a gluten-free~     diet (GFD). For most patients, a gluten-free intake results in a symptomatic and~     pathological complete remission and decreases the risk of complications.~      The overall prevalence of CD is around 1% in several Western countries. An Argentinian study~     shows a 1.167 prevalence of CD in studied patients, being doubled for women than men.~     Another study in a closed population of the Health Plan of Hospital Italiano de Bs As~     estimated a prevalence of 0.22 CD diagnosis. In developed countries, for each diagnosed case~     there is an average of 5-10 cases that have not been diagnosed yet.~      CD patients and their families should be properly informed about GFD, since there are many~     factors, voluntary and involuntary, which can affect the treatment. Even though a strict~     diet is imperative, food handling awareness is equally important in order to prevent~     cross-contamination and gluten intake hidden in certain products.~      In recent years, several countries have shown an increasing interest in improving the supply~     of gluten-free foods in supermarkets, food factories and restaurants. In turn, a British~     study shows that chefs have less awareness about celiac disease than the overall population.~     Another Canadian study, which assessed the quality of life of people with CD, revealed that~     80% of them avoid eating in restaurants for fear of contamination, causing a decrease in~     their social life.~      In Argentina, there are associations that generate lists of marks and gluten-free products~     allowing safe intake of processed foods, however, it is unknown the food supply suitable for~     consumption for people with CD as well as the staff's knowledge in gluten-free food~     preparation in restaurants, pubs, pizzerias and fast food places. U.S. has quality assurance~     systems that certify good manufacturing practices and GFD handling in restaurants and~     selling local foods, although its application is not mandatory. In our country, there is no~     such certification, so food safety on restaurants can not be guaranteed.~      Eating behaviors are influenced by the reality in which people live, including food~     availability indoors and outdoors. The current lifestyle leads more and more people to make~     meals away from home, so that the variety and quality of food sold in restaurants and other~     stores conditions the consumption. Thus, the availability of safe foods in places where~     people with CD carried some of their meals, help improve adherence to the GFD.~      The aim of this study is to investigate gluten-free products' supply in elaborated food~     stores in Buenos Aires City and to discover the level of information possessed by~     manufacturers in the production of food.~   "
56899|NCT02312336|"~     Patients with heart attacks caused by blocked coronary arteries are usually treated with a~     technique called primary angioplasty. Although this treatment is very successful it can~     result in damage to the heart muscle when the artery is opened due to reperfusion injury.~     Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in~     some patients but not in others, however it is uncomfortable due to the shivering, expensive~     and can result in delays in opening the blocked artery. We are investigating a simpler way~     to cool the heart muscle directly using cooled fluid passed through the catheter without the~     shortcomings of entire body cooling. This pilot will address safety and feasibility~     considerations.~   "
56900|NCT02312323|"~     Comparison of different contact lens materials.~   "
56901|NCT02312310|"~     to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin )~     on dentate gyrus function and corresponding cognitive function~   "
56902|NCT02312297|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline~     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with~     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC~     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,~     adult, male, human subjects under fasting condition.~   "
56903|NCT02312284|"~     The aim of this observational study is to retrospectively collect current survival data for~     3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients~     admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to~     December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts~     local recurrence, distant metastases, and survival for patients with rectal cancer treated~     with pre- or postoperative chemoradiotherapy (CRT).~   "
56904|NCT02312271|"~     This prospective observational study seeks to assess ability to achieve enteral feeding~     goals with standard tube feeding formulas.~   "
56905|NCT02312258|"~     The purpose of this study is to determine the effect of ixazomib maintenance therapy on~     progression free survival (PFS) compared with placebo, in participants with newly diagnosed~     multiple myeloma (NDMM) who have had a major response (complete response [CR], very good~     partial response [VGPR], or partial response [PR]) to initial therapy and who have not~     undergone stem-cell transplantation (SCT).~   "
56906|NCT02312245|"~     This phase II trial studies how well Avatar-directed chemotherapy works in treating patients~     with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum~     anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine~     hydrochloride, pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such~     as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Using an~     Avatar, a living tumor sample with similar genetic characteristics to the original tumor,~     may help determine which chemotherapy is most effective.~   "
56907|NCT02312232|"~     The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa,~     3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with~     carbidopa and ODM-104.~   "
56908|NCT02312219|"~     HIV-infected individuals on antiretroviral therapy (ART) are at increased risk for~     cardiovascular disease (CVD), likely due to chronically increased inflammation. Low-dose~     methotrexate (LDMTX) may reduce CVD risk in people with rheumatoid arthritis, who like those~     with HIV, have increased levels of inflammation. The NHLBI is funding a clinical trial~     targeting the excess inflammation in HIV. That Parent Study is a randomized, double-blind,~     placebo-controlled trial that will assess whether 24-week treatment with LDMTX: i) is safe,~     ii) reduces circulating inflammatory biomarkers and levels of immune cell activation and~     iii) improves brachial artery reactivity. However, neither the biomarkers nor endothelial~     function tests measured as part of the parent study will report on atherosclerotic~     inflammation, (the desired pathobiological target of LDMTX therapy in HIV). As such, the~     direct evaluation of arterial inflammation would substantially enhance the scientific value~     of the trial. In this imaging sub-study, the overall goal is to determine if treating~     virologically suppressed, HIV-infected individuals with LDMTX will reduce inflammation~     within the arterial wall.~      This fully integrated ancillary study would, in a subset of patients enrolled in the parent~     trial: (i) assess the impact of LDMTX on arterial inflammation, (ii) evaluate mechanisms~     responsible for arterial inflammation in HIV and iii) explore mechanisms responsible for~     actions of LDMTX on the artery wall. Accordingly, the proposed study would provide unique~     and highly complementary information that would greatly increase the knowledge and~     mechanistic insights gained from Parent Study. The ancillary study has two specific aims1)~     To determine the impact of anti-inflammatory treatment with LDMTX on arterial inflammation,~     as assessed by FDG-PET/CT imaging, in virally suppressed HIV-infected individuals., and 2)~     To evaluate the cellular and biochemical basis of the effect of LDMTX therapy on arterial~     inflammation in HIV.~   "
56909|NCT02312206|"~     This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm~     efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will~     remain on-study until study completion, which will occur when all primary endpoint events~     (all-cause mortality or cardiac hospitalizations) have been reached.~   "
56910|NCT02312193|"~     Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive~     patients and to better understand the mechanisms controlling the myogenic tone. Evaluations~     will be performed through ex vivo studies of peripheral arterioles in human adipose tissue~     from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the~     myogenic function in response to progressive blood pressure increases, in order to correlate~     myogenic function to arterial hypertension and to the molecular mechanisms already~     identified in the preclinical models.~   "
56911|NCT02312180|"~     ProMetic is intiitating a first-in-man study entitled A Phase 1, Dose Escalation, and~     Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults~     and Children with Hypoplasminogenemia. The general objectives of this clinical study,~     (Protocol #2002C005G), are to determine the optimal dose and interval required to support~     the planned Phase 2/3 study and to investigate initial safety and tolerability.~   "
56912|NCT02312167|"~     This study aims at demonstrating the feasibility of probe-based confocal laser~     endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).~      Contraindications for resection surgery may sometimes be missed during exploratory surgical~     procedures. That may lead to an incomplete thus useless surgery and delay the right~     treatment.~      The objectives of this study are to improve the detection of cancer extension during~     exploratory procedures and to guide resection to ensure clear margins.~   "
63816|NCT02221986|"~     The results of the present RCT study will add to the growing body of literature~     investigating the potential role of exercise as a supportive therapeutic intervention for~     patient with glioma.~   "
56913|NCT02312154|"~     IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a~     stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a~     stamp-type electronic multineedle injector.~      OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic~     multineedle injector, and if changes in skin physiology occur earlier than in previous~     trials.~      DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center,~     evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One~     dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin~     content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a~     reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks~     postinjection). The subjects and two independent investigators assessed the clinical~     improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit.~     Twenty-four participants completed the study, and no participants withdrew due to adverse~     effects.~      INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one~     side of the lower cheek. The cheek side to which the treatment was applied was chosen~     randomly.~   "
56914|NCT02312128|"~     The purpose of this study is to evaluate if an early mobilization after distal radius~     fractures treated by surgery leads to an better functional outcome then immobilization after~     surgery for 5 weeks in a cast~   "
56915|NCT02312115|"~     This study will be a randomized prospective double-blind placebo-controlled clinical pilot~     trial. This will be a single center project that will take place at Loma Linda University~     Medical Center. All adult kidney recipients will be informed of the study prior to~     operation. The Nephrology fellows or attending physicians will attempt to obtain informed~     consent from all eligible patients, pre-transplant. Those patients who consent will be~     screened post operation for enrollment. Patients who do not meet all eligibility criteria~     and/or who meet some exclusion criteria will be deemed ineligible for the trial, and will be~     excluded. The Nephrology and Transplant teams will be blinded of patient assignment and only~     the pharmacy will know the patient's assignment.~   "
56916|NCT02312102|"~     This research study is evaluating drugs called bortezomib and lenalidomide as a possible~     treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).~      The purpose of this research study is to determine the safety and efficacy of the bortezomib~     and lenalidomide investigational combination. This drug combination has been used in the~     treatment of relapsed/refractory multiple myeloma and has been previously investigated in~     the treatment of MDS and AML, albeit at a lower dose of lenalidomide. In this research~     study, the investigators are looking for the highest dose of the combination that can be~     given safely and see how well it works as a combination for MDS and AML in individuals whose~     disease has relapsed after an SCT.~   "
56917|NCT02312089|"~     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist~     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)~     following GnRH antagonist protocol~   "
56918|NCT02312076|"~     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist~     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)~     following long GnRHa protocol~   "
56919|NCT02312063|"~     In a prospective, randomized case-controlled study, the investigators hope to demonstrate a~     positive correlation of plasma levels of EPA and DHA as well as fish intake with the~     HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.~   "
56920|NCT02312050|"~     A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in~     patients with chronic kidney disease caused by diabetes. The study will enroll approximately~     375 patients at multiple centers located in the United States. Study duration is 6 months.~     Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride~     Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered~     via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other~     week for an additional 4 months (16 weeks).~   "
56921|NCT02312037|"~     An expanded access/compassionate use protocol that allows access to Mylotarg for~     relapsed/refractory AML CD33 positive patients in the USA.~      Contact: B1761026@iconplc.com~   "
56922|NCT02312024|"~     Registry on the use of the CytoSorb® adsorber in ICU patients.~   "
56923|NCT02312011|"~     This study will test the safety, tolerability, and pharmacokinetics of multiple escalating~     doses of ISIS-DMPKRx administered subcutaneously to adult patients with DM1.~   "
56924|NCT02311998|"~     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     the combination of bosutinib and inotuzumab ozogamicin that can be given to patients with~     Ph+ ALL and CML in the lymphoid blast phase that also expresses CD22.~      The goal of Part 2 is to learn if the dose found in Part 1 can help to control the disease.~      The safety of this drug combination will also be studied.~   "
56925|NCT02311985|"~     The aim of this study is to compare three different blood transfusion strategies for~     coagulopathy correction before central venous catheterization in patients with chronic liver~     failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.~   "
56935|NCT02311855|"~     The main objective is to evaluate the strength and duration of immune response after~     influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with~     biological agents as compared to a group healthy controls who do not have RA. Influenza~     vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post~     vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the~     baseline visit after the baseline blood draw.~   "
57017|NCT02310789|"~     Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced~     expiratory volume in 1 second) improvements than ivacaftor alone, without further~     improvement in sweat chloride results.~      To help understand why sweat chloride was unresponsive, the investigators will use a newly~     developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic~     fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.~      The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days)~     will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by~     measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.~   "
56926|NCT02311972|"~     Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight~     infants experience hypothermia after birth and through stabilization (first 24 hours of~     life) due to an inability to keep warm through metabolic heat production while experiencing~     heat loss during care.~      The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips~     Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor~     with a digital temperature display will enable care-providers to monitor continuous body~     temperature and prompt them to provide warmth and prevent heat loss, thus preventing~     hypothermia in these infants for the first 24 hours of life. The investigator predicts~     infants in the intervention group will have warmer axillary temperatures upon admission to~     the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for~     consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW~     infants and other low birth weight infants 1000-2000 grams will be randomized to the~     intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel~     monitor for continuous digital temperature display, immediately after birth through 24 hours~     of life) or the control group (standard delivery room care and stabilization care). The~     study staff plans to enroll 180 infants (90 per group) to allow for screen failures.~     Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24~     hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care~     Nursery providers who care for an InnerSense study infant and wish to complete a provider~     satisfaction survey. These providers will be asked to provide consent prior to completing~     the survey and their names will be recorded on a separate study enrollment log.~      Infant demographic data will be compared to make sure groups are not significantly~     different. Temperatures from the intervention group will be compared to the control group~     using a student t test at each time point. Satisfaction questionnaires will be summarized~     and described. The InnerSense oral gastric tube with temperature monitoring is FDA approved~     for use and is being marketed commercially by Philips Healthcare. VLBW infants have oral~     gastric tubes placed as standard of care for feeding, and intermittently in the delivery~     room when positive pressure ventilation is necessary for respiratory stabilization. There~     are no additional safety risks to the intervention of this study; however, a safety/data~     monitoring committee will be formed and meet quarterly to monitor the trial.~   "
56927|NCT02311959|"~     This is a phase III, multicentric, single arm study with a sequential design using the exact~     conditional Poisson test.~      The primary objective of this prospective study is to evaluate whether selected breast~     carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable~     low local recurrence rates.~      450 patients will be included over a period of 4 years and will be followed for a 5 years~     period (twice a year).~      All patients must have a complete preoperative evaluation (bilateral mammography, bilateral~     breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma~     (invasive or in situ, all histopathological types, first treatment or relapse).~      The study procedure is represented by nipple areola skin-sparing mastectomy followed by~     immediate breast reconstruction.~      After surgery, early and late complications, including specific complications (suffering of~     the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.~      An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be~     realized throughout the study.~      A complementary study, prospective, non-interventional, will be proposed to patients who~     will benefit from the same surgical technique (NSM) followed by immediate reconstruction,~     but in the context of preventive surgery (prophylactic surgery for patients mutated or high~     genetic risk). The aim of this complementary study, which will include a maximum of 60~     patients, is to evaluate associated morbidity in prophylactic NSM.~      Data will be collected over a 3 months period after surgery.~   "
56928|NCT02311946|"~     This study will investigate whether concurrent administration of rabeprazole, an antacid~     known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given~     as one of six experimental formulations.~   "
56929|NCT02311933|"~     This randomized phase II trial studies how well tamoxifen citrate works compared with~     z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby~     tissue or lymph nodes or other parts of the body and has estrogen receptors but not human~     epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen~     can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen~     hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It~     is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in~     treating patients with breast cancer.~   "
56930|NCT02311920|"~     This phase I trial studies the safety and best dose of ipilimumab, nivolumab, or both in~     combination with temozolomide in treating patients with newly diagnosed glioblastoma or~     gliosarcoma. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth~     in different ways by targeting certain cells. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known which combination is a better treatment for glioblastoma or gliosarcoma.~   "
56931|NCT02311907|"~     This randomized phase III trial is studying glutathione to see how well it works in~     preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with~     ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may~     help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known~     whether glutathione is more effective than a placebo in preventing peripheral neuropathy.~   "
56932|NCT02311894|"~     This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin)~     (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naive to~     prior recombinant human growth hormone (rhGH) treatment. The study is designed to~     characterize the immunogenicity profile of Nutropin AQ v1.1 when administered as a daily~     subcutaneous (SC) injection for 12 months. The clinical impact of immunogenicity will also~     be assessed.~   "
56933|NCT02311881|"~     The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR)~     tablets administered orally, twice daily are effective and safe in the treatment of patients~     with osteoarthritis of the knee or hip.~   "
56934|NCT02311868|"~     The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the~     last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to~     systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the~     blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related~     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to~     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has~     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in~     hemodialysis patients. In the present paper the investigators investigated the effect of a~     probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in~     hemodialysis patients.~   "
57018|NCT02310776|"~     Compare lesion detection of the automated breast ultrasound (ABVS) exam with the~     conventional handheld (HH) breast ultrasound (US) exam.~   "
56936|NCT02311842|"~     Ankylosing spondylitits (AS) is a chronic, systemic rheumatic disease primarily affecting~     spine and sacroiliac joints, which belongs to the group of conditions known as~     spondyloarthopathies and causes eventual fusion of the spine. Twin study in AS estimated a~     heritability of over 90%. HLA-B27 is regarded as the earlist and most important gene~     associated with AS heritability, and over 90% of AS patients carry HLA-B27 gene. HLA-B27 was~     highly polymorphic, and more than 89 subtypes of B27 gene have been found. Subtypes of~     HLA-B27 vary between different regions, and so on as the relationship between HLA-B27~     subtypes and disease development among different races. Anti-TNF- agents were regarded as~     one milestone in recent years development on treatment of ankylosing spondylitis, and most~     patients showed significant improvement after anti-TNF- therapy. Yet part of patients still~     showed insufficient response. Our previous study suggested AS patients carrying different~     genotype of SNP in TNF gene had different response to anti-TNF- therapies. But more studies~     should be carried out to identified more gene polymorphisms associated with treatment~     response. In this study we designed a prospective, open-label trial to investigate the~     genetic difference beween AS patients with different response to anti-TNF- therapy. We plan~     to enroll 50-100 early AS patients which fulfill the 2009 ASAS axial spondyloarthritis~     classification criteria and have axial symptom for no more than 2 years. The patients must~     have high disease activity defined as BASDAI 4, and HLA-B27 test must be positive. The~     patients should be able to receive 24 weeks of etanercept treatment. And patients who have~     previous other anti-TNF- therapy and any contraindication of anti-TNF- therapy must be~     excluded. Other medicines should be stable for at least 4 weeks before etanercept treatment~     begins. For the clinic assessment, patients should fill in the AS questionaires and receive~     physical examination at each visit. ASAS20 is thought as the primary endpoint. For the~     genetic polymorphysm detection, we select 10-20 SNP in MHC region associated with AS and~     5-10 HLA-B27 subtypes which have been worked over and have definite association with AS. At~     the first visit 4ml of anticoagulated blood was collected and DNA was extracted. Target SNPs~     are detected by PCR then direct sequencing. HLA-B27 subtypes are identified using PCRSSP~     methods. And the relationship between SNPs/HLA-B27 subtypes and different response to anti~     TNF- therapy is accessed using chi-square statistic process in SPSS software. In this study~     we plan to investigate the relationship between genetic background and the clinical response~     to anti-TNF- therapy in AS patients, which has been seldom reported before. Our group have~     been studying the disease-associated gene of AS for years, and got plenty of data and~     experience about genetic study of AS.~   "
56937|NCT02311829|"~     The goal of this study is to evaluate effectiveness of the phone follow-up method compared~     to the conventional filler taken one.~   "
56938|NCT02311816|"~     The value of procalcitonin change from the day before to the day when infection was~     suspected in predicting bacterial infection in intensive care patients.~   "
56939|NCT02311803|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic~     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual~     function disorder. However, 32%-44% patients still suffered from urinary and sexual function~     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).~      In the early stage of work, the investigators performed preservation of Denovilliers' fascia~     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low~     rectal cancer patients. The results showed that preservation of Denovilliers' fascia in~     L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In~     order to further confirm the early work, the investigators design a randomized controlled~     clinical trial to compare differences in urinary and sexual function protection and~     long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.~   "
56940|NCT02311790|"~     Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in~     small quantities in foods, most notably in dairy products. Observational evidence suggests a~     positive association between trans-C16:1 and insulin sensitivity, and negative association~     with risk of developing type 2 diabetes mellitus [1-3]. Cis-palmitoleic acid (cis-C16:1) is~     found naturally in foods and is particularly high in macadamia nuts and oil extracted from~     the sea buckthorn plant. Animal models suggest that this palmitoleic acid isomer also~     improves insulin sensitivity and reduces metabolic dysfunction.~      This pilot dosing study is necessary to inform the design of a larger trial to test the~     hypothesis that both trans-C16:1 and cis-C16:1 improve insulin resistance but at different~     doses. Plasma phospholipid fatty acid profiles will be used as the primary outcome measure.~   "
56941|NCT02311777|"~     Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified~     as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone~     limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually~     resistant to a wide variety of treatments (1-4). Three factors may contribute to the~     development of persistent, post-amputation PLP by inducing central sensitization at~     different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli,~     and acute postoperative pain (5-7).~      Investigators hypothesis that pre-amputation period could be important in eliminating~     Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet~     established. The reduction of pre-operative pain and prevention of formation of pain~     memories may eliminate development of PLP by using dual networks treatment strategy. This~     Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the~     efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain~     in patients undergoing lower limb amputation.~   "
56942|NCT02311764|"~     Open label, non-randomised phase II clinical pilot study~   "
56943|NCT02311751|"~     In this study, the investigators will be examining the effects of repetitive transcranial~     magnetic stimulation (rTMS) on executive function deficits in individuals with autism~     spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS~     stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel~     the same as active rTMS only there will be no direct brain stimulation. This is necessary to~     ensure that active rTMS is efficacious in the enhancement of executive function in~     individuals with autism spectrum disorder. Based on results from a recently published pilot~     study, the investigators propose that active rTMS treatment will result in a significant~     improvement in working memory performance compared to sham rTMS treatment.~   "
56956|NCT02311582|"~     The blood brain barrier (BBB) is a major obstacle to drug delivery in the treatment of~     malignant brain tumors including Glioblastoma multiforme (GBM). MRI-guided laser ablation~     (MLA) has been noted to disrupt peritumoral BBB, which could then lead to increased access~     of new tumor antigens to the lymphovascular system and vice versa of immune effector cells~     to the tumor for effective activation of the immune system. Therefore the combination of~     MK-3475 and MLA as proposed in this protocol is hypothesized to create a therapeutic synergy~     in which MLA increases material access to promote immune activation and then MK-3475~     maximizes these tumor-specific immune reactions to impart effective tumor control.~   "
57086|NCT02309892|"~     The primary purpose of this research study is to evaluate how safe, how well tolerated and~     how effective a range of doses of L-DOS47 in combination with standard doublet therapy of~     pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic~     non-squamous Non-Small Cell Lung Cancer.~   "
56944|NCT02311738|"~     Regular exercise has several positive health effects including increased physical fitness~     and muscle mass. It is well known that increased muscle mass is associated with increased~     resting energy expenditure which may facilitate weight loss and maintenance. Previous~     studies have, however, failed to show any consistent association between the intensity of~     physical exercise and energy expenditure, or relate the variance in these adaptations to~     genetic variability. Whether high-intensity exercise (HIE) is associated with improved~     health related quality of life in severely obese patients remains unknown.~      This PhD-project is based on a planned randomised controlled study including 50 or more~     treatment seeking morbidly obese patients who will be randomised to either a 24 week~     moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE)~     programme. The investigators main hypothesis is that patients randomised to the HIE-program~     will achieve higher energy expenditure during rest and physical activity after treatment~     than those allocated to the MIE-programme. In addition, the investigators hypothesise that~     the HIE-group will achieve a better health related quality of life than the MIE-group after~     treatment. The investigators also hypothesize that inter-individual variability in~     adaptation to the two training regimens may be due to genetic factors. If the investigators~     hypotheses are confirmed, this project might have beneficial clinical implications for~     future obesity treatment strategies.~   "
56945|NCT02311725|"~     The overall aim of this program of research is to refine and test a newly developed~     storytelling video intervention (sTVi) for depressed primary care patients.~      The purpose of the proposed project is to establish the feasibility, acceptability, and~     preliminary effects of the intervention for an eventual large-scale randomized clinical~     trial which would test the efficacy of sTVi in comparison to a control condition.~      To achieve the specific aims, the investigators will conduct a pilot randomized clinical~     trial (n = 40), with two treatment arms: antidepressant treatment as usual (aTAU) + sTVI vs~     aTAU + attention control videos.~   "
56946|NCT02311712|"~     The aim of this study is to assess the effects of implementation of a non-endoscopic~     esophageal cancer-screening program on outcomes of interest in an asymptomatic high-risk~     population in Golestan Province, Iran. Study population will be recruited in two arms. In~     the intervention arm, cytological examination of the esophagus will be performed using a~     capsule sponge device. Subjects in the control arm will receive no intervention. All~     participants will be followed for 5 years. The outcomes of interest, including the incidence~     of esophageal cancer as well as mortality rates, will be compared between the two groups.~   "
56947|NCT02311699|"~     Violence against women (VAW), the most extreme manifestation of the unequal power balance~     between women and men, is a major global public health concern. One of the most common forms~     of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of~     women reported having experienced physical and/or sexual intimate partner violence (IPV) in~     their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence~     has also linked IPV and HIV risk.~      This study is a cluster randomized controlled trial assessing the impact of a~     community-based intervention focused on Intimate Partner Violence and HIV delivered in the~     context of the Ethiopian coffee ceremony, a culturally established forum for community~     discussion and conflict resolution. Villages will be randomly assigned to one of 4 study~     arms (3 intervention and one control arm): 1) Women only participate in the intervention, 2)~     Men only participate, 3) Both men and women (couples) participate, 4) Women and men receive~     the control intervention comprising a short informational session on violence reduction.~   "
56948|NCT02311686|"~     The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl~     glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration~     of increasing doses of alcohol in adult subjects.~   "
56949|NCT02311673|"~     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)~     injectable formulation of RM-493 in obese subjects with Prader-Willi syndrome on~     tolerability, weight loss and hyperphagia-related behavior. The study drug (RM-493 and~     placebo) will be administered in a blinded fashion.~      Funding Source - FDA OOPD~   "
56950|NCT02311660|"~     This is an open label interventional study using an implantable vagus nerve stimulation~     device in patients with Crohn's disease who have active disease despite treatment with a~     tumor necrosis factor (TNF) antagonist drug.~   "
56951|NCT02311647|"~     The aim of this multi-center study is to assess the effects of Tamoxifen on the uterine~     cavity and endometrial abnormalities in young premenopausal women diagnosed with breast~     cancer.~      The research contains two parts: a clinical study and a laboratory study.~        -  Clinical part: to evaluate the association between tamoxifen treatment and uterine~          abnormalities.~        -  Laboratory part: to investigate the effect of Tamoxifen treatment on endometrial~          tissue, by exploring the molecular aspect of endometrial receptivity.~   "
56952|NCT02311634|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than transvaginal electrical stimulation in treating urge urinary~     incontinence (UUI).~   "
56953|NCT02311621|"~     Patients with recurrent or refractory neuroblastoma are resistance to conventional~     chemotherapy. For this reason, the investigators are attempting to use T cells obtained~     directly from the patient, which can be genetically modified to express a chimeric antigen~     receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell~     through the recognition of CD171, a protein expressed of the surface of the neuroblastoma~     cell in patients with neuroblastoma. This is a phase 1 study designed to determine the~     maximum tolerated dose of the CAR+ T cells.~   "
56954|NCT02311608|"~     To observe and access the Effects and safety of terlipressin or high dose~     somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis~     in patients with acute variceal bleeding.~   "
56955|NCT02311595|"~     The purpose of this study is to determine if reduced port totally laparoscopic distal~     gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and~     oncological feasible.~      67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced~     port totally laparoscopic distal gastrectomy.~      The primary end point of this study is to measure compliance rate with pathology report and~     compare with previous compliance rate data.~   "
56980|NCT02311270|"~     The purpose of this study is to learn about the effects of long term carnitine use in~     patients with metabolic disorders and its potential relationship to cardiovascular events.~   "
56957|NCT02311569|"~     The aim of this phase II study is to test a novel concept in the treatment of patients with~     myeloproliferative neoplasms (MPN), a disease of the bone marrow. With no current cure~     available, MPN are a group of chronic leukemias (blood cancers) in which patients produce~     too many blood cells. These increased blood cell numbers cause problems to the patient such~     as bleedings or thrombosis and some patients may progress to acute leukemia, a life~     threatening condition. Most MPN patients have a gene mutation called JAK2-V617F. The disease~     is maintained by mutant MPN stem cells that reside in the bone marrow in specialized~     locations called niches. These niches need connections to the nervous system. New findings~     show that these connections are destroyed by the presence of the mutated MPN stem cells.~     Research teams found that some drugs (beta3-sympathicomimetics) can restore these damaged~     niches and at the same time reduce the MPN disease manifestation in a mouse model of MPN.~     Such sympathicomimetic drugs are already being used to treat patients with asthma or~     hyperactive bladder. These drugs have shown to have only few side effects. The study tests~     the effects of the beta-3-sympathicomimetic drug Mirabegron (Betmiga®) on MPN disease in 39~     patients that carry a JAK2-V617F mutation. The hypothesis is that Mirabegron will have a~     beneficial effect on bone marrow niche cells and will thereby improve the disease~     manifestation in MPN patients. This study should provide a rapid answer whether targeting~     the nervous system of the niche cells could be useful for patients with MPN and warrants to~     be tested in larger and more long-term studies.~   "
56958|NCT02311556|"~     This study is designed to evaluate whether advanced magnetic resonance imaging (MRI)~     techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be~     used to predict treatment response of brain metastasis after radiosurgery.~   "
56959|NCT02311543|"~     Axillary lymph node dissection remains an integral part of surgical treatment of primarily~     node-positive invasive breast cancer. In order to reduce the incidence of clinically~     relevant seroma, a suction drain is routinely placed into the axillary cavity after axillary~     lymph node dissection (ALND) by a separate stab incision. The pathogenesis of seroma~     involves the collection of lymph fluid caused by dissection of lymph vessels and exudate.~     All coagulation and fibrinolytic factors are produced and secreted by lymphatic endothelial~     cells and are involved in the sealing of lymphatic capillaries. Local hemostyptic agents may~     therefore reduce postoperative secretion from lymphatic fistulas caused by ALND.~      We propose to conduct a multicenter prospective randomized control trial in Switzerland to~     evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of~     an equine collagen sponge coated with human fibrinogen and human thrombin) on axillary~     drainage after ALND for breast cancer. We hypothesize that the use of TachoSil®~     significantly and relevantly reduces the volume and duration of axillary drainage after~     ALND. This has the potential to increase patients' quality of life, as well as to shorten~     the length of hospital stay and reduce hospital costs.~   "
56960|NCT02311530|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended~     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories~     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)~     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP~     Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.~   "
56961|NCT02311517|"~     Postoperative pain still remains a challenging problem in patients undergoing video-assisted~     thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for~     VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described~     recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the~     possibility to provide analgesia following thoracic surgery. Pain following surgery is a~     critical side effect of surgery, which increases the risk of complications and delays a~     recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the~     quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided~     SPB on the quality of recovery and pain in patients undergoing VATS.~   "
56962|NCT02311504|"~     In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive~     survey are conducted after recruitment in secondary diabetes care centers. All patients~     undergo a comprehensive eye examination including wide-angle fundus photograph and ocular~     cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes~     duration, type of treatment), knowledge and personal attitudes of the persons affected. The~     relevant lab findings were collected from the electronic files.~      Main focus of the study is the concordance to the national screening recommendations (last~     eye exam, presence of retinopathy).~   "
56963|NCT02311491|"~     Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will~     reduce the sliding resistance of archwires in the brackets during orthodontic treatment~     procedures.~      Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years~     of age and 45 years old will be otherwise healthy subjects previously diagnosed with~     malocclusion.~      Procedures (methods): Each subject will receive an experimental (coated) or a regular~     (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images~     of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The~     AW will be removed and retrieved after the 3-month trial.~   "
56964|NCT02311478|"~     This study aims to use validated tools as well as new technology to examine changes in~     bleeding patterns among women who are initiating the copper T380A IUD.~   "
56965|NCT02311465|"~     The purpose of this research study is to find out whether it is better to introduce cancer~     patients to the palliative care team at a later date when there is a specific issue or~     problem or to introduce cancer patients to the palliative care team when first diagnosed~     before any specific issue or problem occurs.~   "
56981|NCT02311257|"~     The purpose of this study is to learn about the use of nutritional supplements in patients~     with mitochondrial disease.~   "
56982|NCT02311244|"~     This observational study is aimed at identifying new molecular promoters of mortality (and~     morbidity) in patients with type 2 diabetes mellitus (T2DM).~   "
56983|NCT02311231|"~     In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone~     (according to local protocol) in reducing death, MI, and major bleeding in patients with~     NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.~   "
56966|NCT02311452|"~     Some children get serious bacterial infections that require hospitalization and then a long~     course of antibiotics to completely treat the infection. Examples of these serious~     infections include ruptured appendicitis (when the appendix gets inflamed and bursts,~     releasing bacteria into the abdomen), complicated pneumonia (when an infected pocket of pus~     forms either in the lung or between the lung and chest wall), and osteomyelitis (an~     infection of the bone). To extend the duration of antibiotic therapy after discharge from~     the hospital, doctors will often insert a long catheter called a PICC line in the child's~     vein, which can stay in the body for several weeks. However, PICC lines require a fair~     amount of maintenance and training of caregivers in their use, require children to restrict~     their activities, and can lead to serious complications, such as blood stream infections and~     clots. An alternative to PICC lines is extending the duration of antibiotic therapy with~     oral antibiotics (pills or syrup) that achieve high levels of medicine in the blood and do~     not have the extra work, inconvenience and risks of PICC lines. Unfortunately, there are~     very few high quality studies that have demonstrated that oral antibiotics are just as good~     as intravenous antibiotics delivered via a PICC line, and so many doctors still recommend~     the PICC line treatment option. Also, no studies have been done to compare the impact of~     these two treatment options on the quality of life of the child and their caregivers.~      In this proposal the investigator outline a series of projects to compare oral antibiotics~     vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at~     least 1 week) home antibiotic therapy after hospitalization for three different serious~     bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To~     see whether oral antibiotics are just as good as PICC lines, the investigators will use data~     collected from over 15,000 children with one of these three infections who were hospitalized~     at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC~     lines resulted in fewer rehospitalizations for treatment failure than oral therapy.~   "
56967|NCT02311439|"~     This prospective cohort, phase II, trial is studying induction chemotherapy combination,~     FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil~     (5-FU), for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in~     non-progressed cases, in treating patients with locally advanced cancer pancreas.~   "
56968|NCT02311426|"~     The study is a comparative effectiveness study with comparision of two cohorts of patients~     with stroke in North of Norway and in Denmark. At baseline information is collected from the~     stroke registries in both countries. Time points for follow up are at 3 and 12 months~     post-stroke. Data are collected from medical charts and with use of telephone interview in~     addition to self-report questionnaires. The study will provide information about mortality,~     functional status and quality of life. Information about rehabilitation services in both~     countries are collected and compared, and analysed in relation to patients outcome.~   "
56969|NCT02311413|"~     The goal of this study is to identify changes in cells that are related to the treatment~     with Cat-PAD (ToleroMune Cat).~   "
56970|NCT02311400|"~     Background:~      - People respond differently to life events and how those events make them feel. They also~     respond differently to information about the how their actions affect their lives and~     health. Researchers want to learn more about these differences. In this study, researchers~     will look at how people respond to an event in their life. Researchers will also look at how~     people respond to information about how their actions can affect their health.~      Objective:~      - To see how people respond differently to life events and information about alcohol and~     breast cancer.~      Eligibility:~      - Women 18 and older who have never been diagnosed with cancer and who drank 5 or more~     alcoholic drinks in the past week.~      Design:~        -  This study will take place online.~        -  Participants will be randomly assigned to 1 of 10 groups.~        -  Researchers will ask participants to take part in 2 small studies, 1 about Life Events~          and 1~      about Alcohol and Breast Cancer.~        -  In the Life Events study, participants will write briefly about a time they felt very~          happy, fearful, angry, or surprised, or they will write about a room in their house.~          Then they will answer questions about that event. They also will write about a value~          that is or is not important to them.~        -  In the Alcohol and Breast Cancer study, participants will read a health message about~          the link between alcohol and breast cancer. Then they will answer questions about what~          they read and give their thoughts about alcohol and breast cancer.~        -  Both studies should take about 30 minutes.~   "
56971|NCT02311387|"~     Background:~      - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow~     fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and~     droppings. When a group of researchers tested the mice in Soromba, Mali, they found that~     many were infected with Lassa fever. Lassa fever may also be passed through body fluids~     (like blood or semen) of people infected with Lassa fever. Researchers want to study this~     disease to help the government better protect the health of people in Sibirila.~      Objectives:~      - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how~     many people get the disease every year.~      Eligibility:~      - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no~     plans to relocate within 1 year.~      Design:~        -  Households will be randomly selected to participate in the study.~        -  Participants will have up to 20 drops of blood collected from the finger or heel.~        -  Participants will be asked about their age. They will be asked if they have ever had a~          fever and if they have ever seen mice in or around their home.~        -  Researchers will come back in 1 year and take another drop of blood from the~          participant. Participants will be asked the same questions.~        -  If a participant has a fever at any time during the year, he or she should go to the~          health center. Researchers~      will collect a few drops of blood to test for Lassa fever.~   "
56972|NCT02311374|"~     Background:~      - The glymphatic system helps keep harmful waste from building up in the brain. Researchers~     think it is more active in people during sleep than while awake. They want to study the~     glymphatic system using magnetic resonance imaging (MRI).~      Objective:~      - To see if there are differences in the way waste is removed from the brain while a person~     is sleeping versus awake.~      Eligibility:~      - Healthy people age 18-60.~      Design:~        -  This study is in 2 parts.~        -  For the technical part, participants will be screened with medical history and physical~          exam. They will have urine and breath alcohol tests.~        -  Participants will have 2 MRI scans. Before the scans, they will have urine and breath~          alcohol tests, and complete a questionnaire.~        -  For MRI, participants will lie on a table that slides in and out of a metal cylinder. A~          device will be placed over their head. They will lie still for up to 20 minutes at a~          time. They may be asked to stay awake or fall asleep for up to 2 hours at a time.~        -  For the research part, participants will be screened with medical history and physical~          exam. They will have urine and breath alcohol tests. For 1 week they will wear a device~          that monitors their activity and sleep.~        -  Participants will stay at NIH overnight. They will give a blood sample, have urine and~          breath alcohol tests, and complete a questionnaire.~        -  Participants will take memory, concentration, and thinking tests.~        -  Participants will have 3 MRI scans. An electroencephalography machine will record their~          brain activity. Electrodes will be placed on their scalp.~   "
56973|NCT02311361|"~     Background:~      - Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving~     very focused beams of radiation to tumors. Researchers think the drugs used in this study~     might work better used with SBRT in people with pancreatic cancer.~      Objective:~      - To study the safety and effectiveness of MEDI4736 and/or tremelimumab with SBRT.~      Eligibility:~      - People 18 and older who have pancreatic cancer that has not responded to chemotherapy.~     They must be candidates for radiation but not resection.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood tests. Their tumor will be measured using computerized tomography (CT) or~          magnetic resonance imaging (MRI).~        -  Participants will have their tumor biopsied with a needle. They will have also have a~          biopsy after cycle 1.~        -  Participants will get 1 of 2 drugs.~        -  MEDI4736 therapy will be given in 28-day cycles. Participants will get the drug through~          an intravenous (IV) infusion twice in each cycle.~        -  For tremelimumab, therapy for the first 6 cycles will each last 28 days. Then cycles~          will each last 12 weeks. Participants will get the drug through an IV once in each~          cycle.~        -  All participants will have SBRT. Some will get 1 dose of radiation and some will get 5.~          CT scans will map their tumor.~        -  Participants will have medical history, physical exam, and blood tests in each cycle.~          They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12~          months.~        -  Participants will be contacted yearly for follow-up.~   "
56974|NCT02311348|"~     Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver~     biopsy (PLB) is done through a needle on the right side of your belly. In a transjugular~     liver biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in.~     The tube goes down to your liver and a piece of liver is removed. Researchers want to learn~     more about the pain people feel after each of these procedures.~      Objectives: To compare whether there is more pain associated with the PLB versus TLB.~      Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver~     biopsy. They must be able to read, write, and speak English.~      Design: Under the separate protocol (91-DK-0214), participants will be screened and have a~     liver biopsy.~      Before the biopsy, participants will give their medical history. They will answer questions~     about past surgeries and how they feel about pain.~      Participants will have a pain test with a device called a dolorimeter. They will sit up with~     their feet on the ground, and put their thumbs on a table. They will feel pressure on each~     thumb until it they say it is painful.~      Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.~   "
56975|NCT02311335|"~     Background:~      - Genes are the instructions our body uses to function. Researchers can look for changes, or~     variants, in the genes. The goal of this study is to find new gene changes that lead to~     lipid disorders. Older research methods looked at one or a few genes at a time. Genomic~     sequencing looks at most of the genes at once. Genomic sequencing may find the cause~     researchers haven t been able to find from past methods.~      Objectives:~      - To better understand genetic causes of lipid disorders through genomic sequencing.~      Eligibility:~      - People age 2 and older with unusual lipid disorders, and their relatives.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have~          blood taken. They may give a saliva sample.~        -  Based on the screening test, researchers will chose 3 5 family members to perform the~          genomic sequencing. The sequencing will be done on a sample of DNA collected during the~          blood draw and saliva sample.~        -  Participants may be invited to take part in other protocols that may involve imaging of~          their heart or blood vessels. They do not have to participate. If they do, they will~          sign a separate consent for those tests.~        -  If a participant s family member cannot travel to the NIH, the NIH documents and~          consent will be reviewed during a teleconference. A blood or sputum kit will be mailed~          to them.~   "
56976|NCT02311322|"~     Background:~      - Some growth disorders are caused by a change in genes. Genes are the instructions the body~     uses to function. Changes in genes often cause them not to work correctly. Researchers want~     to use a new technology called exome sequencing, to look at many genes at once. This is done~     by looking at DNA from blood or saliva in a lab. This method may help find the cause of~     disorders that researchers haven t been able to find using past methods.~      Objectives:~      - To better understand genetic causes of growth disorders.~      Eligibility:~      - Children and adults with growth disorders and their family members.~      Design:~        -  Participants will give a small sample of blood and/or saliva.~        -  Researchers will purify DNA from the sample. They will perform exome sequencing and~          other tests to look for changes in genes. Some participants may receive limited or no~          genetic tests. Researchers will let them know if exome sequencing is performed.~        -  Participants may have a medical history, physical exam, and lab tests. They may have~          x-rays or ultrasound tests to study the disorder in their family.~        -  Some participants may be recommended for a specific genetic test from a commercial lab.~          They may have to pay for that test.~        -  Participants will be told about test results that relate to the growth disorder. This~          may happen up to years after the testing. They may have to give another blood and/or~          saliva sample.~        -  Some participants may get results about other health conditions. This will only happen~          if the information would help the person or their family protect their health. They may~          have to give another blood and/or saliva sample.~   "
56977|NCT02311309|"~     Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e.~     cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion~     remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown.~     The investigators conducted a prospective study in order to examine the incidence, and risk~     factors associated with peroperative bleeding and transfusion.~   "
56978|NCT02311296|"~     Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source~     of infection among patients receiving mechanical ventilation. Patients on mechanical~     ventilation accumulate secretion leading to aspiration of infected secretions. Using new~     generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.~   "
56979|NCT02311283|"~     The purpose of this study is to determine if patients participating in The Longitudinal~     Study of Urea Cycle Disorders are different than participants in the Urea Cycles Disorders~     Consortium (UCDC) Rare Diseases Clinical Research Network (RDCRN) Contact Registry and to~     determine if patients are a good source of medical information.~   "
56984|NCT02311218|"~     In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges~     with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The~     effect of these Lactobacillus reuteri strains on the oral microbial composition was~     monitored before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was~     completed. For this purpose saliva and tooth plaque was collected. Of 44 included subjects,~     41 completed the study. The used Lactobacillus reuteri containing lozenges are commercially~     available and identical placebo lozenges was obtained from the manufacturer. The study~     product was well tolerated with no observed side effects. Compliance was excellent.~      The investigators' primary outcome was to determine whether daily intake of Lactobacillus~     reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial~     plaque composition determined by a multiplex sequencing technique. Effects are put in~     relation to general knowledge on bacterial profiles associated with risk to develop dental~     caries and periodontitis.~   "
56985|NCT02311205|"~     This study is a phase II, prospective, open-label, single arm, single center study of the~     efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and~     sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the~     55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone,~     lymph node, adrenal gland) metastasis will be included.~      On demand conventional TACE will be performed in all the patients after enrollment and can~     be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be~     started 3-7 days after the first and each subsequent TACE and stopped one day before next~     TACE and will be continued until sorafenib failure, consent withdrawal or condition~     worsening by clinical decision. Repeated on-demand TACE and sorafenib should continue until~     the criteria for treatment discontinuation are met. After initiation of sorafenib~     combination treatment, patients will be seen and will perform routine examination at week 4~     and, after then routine examination will be followed every 6 ± 2 weeks.~   "
56986|NCT02311192|"~     This study is aimed at creation and validation of a vitreous haze scoring system using~     ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and~     quantification of inflammation will be done to create the scoring scale.~   "
56987|NCT02311179|"~     This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the~     fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the~     type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used.~     The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will~     be compared with an identical cup without hydroxyapatite.~   "
56988|NCT02311166|"~     Introduction: The lack of congruence between the acetabulum and femoral head in hip~     dysplasia compromise the passive stability of the hip joint resulting in increased stress on~     the acetabular labrum, joint capsule and the muscles acting close to the hip joint. Soft~     tissue injury is present in hip dysplasia, and pathology of the iliopsoas muscle has been~     found in 18-50%. To our knowledge, no studies have systematically examined the prevalence of~     soft tissue pathology in hip dysplasia.~      The overall aim of this research project is to examine soft tissue pathology in 100 patients~     with hip dysplasia prior to and one year after Periacetabular osteotomy (PAO).~      Methods: Soft tissue pathology will be examined in a prospective cohort study on 100~     patients with hip dysplasia prior to and one year after surgery. Pathology will be examined~     using ultrasonography and the Clinical Entities Approach that focus on pathology of the~     iliopsoas, adductors, rectus abdominis, gluteus medius and hamstrings. Furthermore, hip~     muscle strength is tested with a dynamometer, hip related health is measured with the~     Copenhagen Hip and Groin Outcome Score (HAGOS) and physical activity is measured with~     triaxial accelerometers during a period of 7 days.~      Perspective: Is it possible to demonstrate pathology of the hip muscles and tendons applying~     clinical tests, muscle strength tests, and ultrasonography, as it has been found in~     sports-active people with groin pain, it will make sense to plan and test a specific~     training program focusing on the pathological soft tissue pathology.~   "
56989|NCT02311153|"~     Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when~     delivering general anesthesia to patients during a variety of operative procedures. LMA's~     have been studied in a wide range of otolaryngologic procedures, and are generally safe and~     accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate~     the safety and efficacy of LMA for airway management during sinonasal surgery by directly~     comparing them to endotracheal intubation in a prospective randomized single‐blind study.~   "
56990|NCT02311140|"~     The aim of the proposed trial in assessment of effects of Kalydeco™ treatment on sinonasal~     involvement in CF patients with at least one mutation of G551D receiving a new therapy with~     the CFTR potentiator. The focus will be given on changes in epithelial lining fluid~     inflammatory markers from CF upper airways sampled by nasal lavage.~      The program is subdivided into a part A assessing inflammatory markers in NL and sinonasal~     symptoms longitudinally from pre-treatment to months with the new therapy.~      Part B will only be performed in a smaller subgroup and assess inflammatory markers in NL~     every second day in the first month of treatment and then every week until the end of month~     3 with Kalydeco™ therapy.~   "
56991|NCT02311127|"~     Peripherally inserted central catheters (PICCs ) are used for the administration of~     intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and~     are safeguarded from migration or accidental dislodgement by securement devices. Different~     types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with~     an adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then~     the system is closed with gull-wings . StatLock® has to be changed weekly. Healthcare~     providers have to pay attention to prevent accidental catheter dislodgement during the~     renewal procedure. SecurAcath® (Interrad Medical) is a new securement device to the European~     market. The device uses a small subcutaneous anchor to secure the PICC. One of the~     advantages compared to adhesive stabilization devices, is a reduction in maintenance time by~     simplifying dressing changes and subsequently staff time. It is described that nurses report~     that care is left undone due to low staffing levels. Therefore, investigation of nursing~     time savings with the support of technology is imperative. SecurAcath® remains in place for~     life of the PICC and therefore has the potential to reduce the time for dressing change as~     there is no need for weekly device change. The objective of this study is to measure nursing~     time for dressing change and explore inserting and removal issues and patient experiences.~   "
56992|NCT02311114|"~     This study will evaluate the Telehomecare (THC) Program offered to patients with heart~     failure or chronic obstructive pulmonary disease across the Central West, Toronto Central~     and North East Local Health Integration Networks in Ontario. It will explore the opinions~     and experiences of patients, providers, technicians and administrators involved with THC~     Program in order to provide stakeholders with information about the processes and~     organizational factors impacting the program's adoption, the experiences of its~     participants, impact on patient outcomes, costs to the health-care system and who is~     benefiting the most from participating. These factors will be determined using~     semi-structured interviews, surveys, and observation of practices of everyone involved with~     THC. The study will also evaluate patient data to determine changes in patients' utilization~     of healthcare services.~   "
56993|NCT02311101|"~     The study aims to establish the safety and toxicity of a combined intravesical mitomycin C~     with BCG for patients with bladder cancer.~   "
56994|NCT02311088|"~     Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies~     have implied a possible role of adenosine. The purpose of this study is to determine if the~     caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.~   "
56995|NCT02311075|"~     Endothelial dysfunction of conduit arteries plays an important role in the development of~     cardiovascular complications associated with type 2 diabetes. In order to propose targeted~     therapeutic approaches, this study aim to determine the mechanisms involved in endothelial~     dysfunction of conduit arteries in these patients.~   "
56996|NCT02311062|"~     This investigation is aimed to examine the effects of two different exercise-oriented~     protocols on the knee torque-angle relationship of the knee flexors.~      Thirty two young soccer players were be randomly assigned to three groups:~     hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The~     ECC and UNS groups performed eighteen sessions over 6 weeks of an injury prevention~     protocol, using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque~     relationship was measured before and after the training intervention. Voluntary isometric~     torque was recorded at six test angles, with participants prone (35º-100º; 0º on full~     extension).~   "
56997|NCT02311049|"~     External beam radiotherapy (RT) is one of the standard curative treatment options for~     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term~     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of~     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.~     The sensitivity of different tissues to fractionation changes can be quantified through the~     alpha/beta ratio in the linear-quadratic model. Dose-response analysis of PC patients~     treated with both external beam RT and brachytherapy has led to the hypothesis that the~     alpha/beta ratio of PC is lower than for most other tumors and approaches a value~     characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been~     calculated. If the alpha/beta ratio of PC is indeed low, then hypofractionating RT~     treatments can theoretically maintain high bioequivalent tumor doses, shorten overall~     treatment time and decrease late toxicities.The advantages in terms of patient convenience~     and treatment cost are obvious. There is level I evidence that shows that hypofractionated~     radiotherapy schedules have at least equivalent biochemical outcome with only a small~     increase in acute but not late toxicity when compared to conventional fractionation RT~     schedules.~      Results on different hypofractionation schedules have been reported, however the optimal~     hypofractionation is not clear so far. In this randomised trial we would like to compare 2~     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25~     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late~     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be~     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size~     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse~     bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern~     design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72~     patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or~     worse GI complications, then the study arm was to be rejected. To allow for a dropout of~     10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated~     analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse~     GI complications with an expected rate of 25%. When including 155 patients per group (310 in~     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients~     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The~     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%~     allowance for dropout.~   "
56998|NCT02311036|"~     The purpose of the study is to investigate the effects and outcome predictors on functional~     recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.~   "
56999|NCT02311023|"~     This is an open trial of intermittent fasting in a group of patients with refractory~     seizures. Patients will continue on the diet for 6 months to assess the impact of the diet~     on seizure frequency.~   "
57000|NCT02311010|"~     To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after~     kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding~     of the genetic Cyp 450 3A5 polymorphism of the recipient.~      The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is~     reached.~   "
57001|NCT02310997|"~     This trial is looking at using umbilical cord blood from unrelated donors after high dose~     chemotherapy. It is for people who have cancer of the bone marrow or lymphatic system~     including leukaemia and lymphoma, or a blood disorder called myelodysplastic syndrome (MDS).~      The trial is for babies over 4 weeks old, children, and adults up to the age of 45.~   "
57002|NCT02310984|"~     This project which is fully funded by the European Union FP7 Program is designed to pull~     together all the information we obtain from scans and x-rays to design a personalised 3-D~     digital model of each patient, their anatomy and disease. We can then use this as follows:~     as (i) an aid to surgical planning to enable objective clinical decision making (ii) a~     decision support tool to communicate the available treatment options to the patient and~     facilitate shared decision making and provision of personalised care and (iii) to enable~     standardised objective evaluation of the aesthetic outcome of the treatment procedures. This~     study aims to demonstrate the ability of the Virtual Physiological Human concept to empower~     breast cancer patients and assess the impact on their care and quality of life.~   "
57003|NCT02310971|"~     The purpose of this study is to assess the safety and tolerability of CVac, an~     investigational cell therapy, in patients with resected stage I or II adenocarcinoma of the~     pancreas who have completed surgery with or without front-line chemotherapy or radiation~     therapy.~      After confirmation of non-measurable disease patients will undergo leukapheresis for~     manufacture of the study agent.~   "
57004|NCT02310958|"~     The investigators plan a retrospective, single-center outcome analysis of laparoscopic~     hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data~     analysis will be based on a review of hospital records and a questionnaire answered by~     families. Patient demographics (age, gender), affected side, type and duration of~     laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative~     complications, eg. infections, length and type of postoperative pain medication, and length~     of the postoperative hospital stay) will be analysed.~   "
57005|NCT02310945|"~     Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors~     outside of local joint pathology, such as pain sensitization, can contribute significantly~     to the pain experience. It is unknown how pain sensitization influences outcomes from~     commonly employed interventions such as physiotherapy.~      The aims of this study are, firstly to identify people with knee OA who display signs and~     symptoms associated with pain sensitization using clinical tools and quantitative sensory~     testing. Secondly, we will investigate if indications of pain sensitization at baseline are~     associated with poor outcome following physiotherapy.~      Methods and analysis:~      This is a multi-centre prospective cohort study with 140 participants. Eligible patients~     with moderate/severe symptomatic knee osteoarthritis will be identified at hospital~     outpatient clinics. A baseline assessment will provide a comprehensive description of the~     somatosensory characteristics of each participant by means of clinical examination,~     quantitative sensory testing and validated questionnaires measuring pain and functional~     capacity. Participants will then undergo physiotherapy treatment, in line with current~     clinical guidelines. Follow-up post physiotherapy treatment (estimated to be at 3 months)~     will assess pain, disability (sub-scales of Western Ontario and McMasters University Score~     Osteoarthritis Index) and participants' global rating of change. These primary outcome~     measures will dichotomise participants into treatment 'responders' and 'non-responders'~     according to the Osteoarthritis Research Society International (OARSI) treatment responder~     criteria.~      For data analysis results from pressure pain thresholds, temporal summation and conditioned~     pain modulation will create a composite score of pain sensitization. Logistic regression~     will explore the relationship between response to physiotherapy and pain sensitization at~     baseline while accounting for various cofounders.~   "
57006|NCT02310932|"~     This cluster Randomized Controlled Trial was designed to implement and evaluate the effects~     of a multi-level intervention designed to integrate mental health treatment into rural~     primary health clinics in South India using a collaborative care model.~   "
57007|NCT02310919|"~     This is a randomized, double-blind, single center clinical trial study to compare the oocyte~     maturity, embryo development, and risk of ovarian hyperstimulation syndrome (OHSS) after~     receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a~     lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women~     undergoing in vitro fertilization (IVF).~   "
57008|NCT02310906|"~     This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability,~     efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients~     with deletions amenable to exon 53 skipping.~   "
57009|NCT02310893|"~     Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL),~     prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits~     communities by reducing transmission to others. Mere availability of ART and care, however,~     is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the~     health care provider, regular monitoring and regular delivery of medications, - known as~     retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons,~     especially low-income minorities are out of care. Innovative interventions are therefore~     urgently needed to maximize engagement and retention in HIV care, self-reported adherence,~     as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study~     will assess outcomes of the following interventions in comparison to usual care: 1)~     contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach~     that integrates both CM and PN (CA) which the investigators hypothesize to be most effective~     in improving HIV clinical outcomes.~   "
57010|NCT02310880|"~     Low vision patients have difficulty acquiring sufficient visual information in a timely~     manner for the purpose of performing challenging daily tasks, such as traveling~     independently and safely through busy streets. The advance of virtual reality techniques has~     provided a potential platform for training low vision patients to use their remaining vision~     more efficiently, but the key issue is always whether the patient's visual experiences in a~     virtual world can be transferred to the real world. The proposed study is designed to~     provide definite answer to this question.~   "
57011|NCT02310867|"~     The purpose of this study is to determine the safety and efficacy of hand transplantation as~     a treatment for patients with loss of limb below the elbow, The study will focus on patients~     who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb~     in activities of daily living at 18 months following transplantation measured by a~     quantitative functional test.~      Study activities include several study visits over 18 months and include; demographics,~     medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone~     density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have~     loss of limb will be included in study evaluation.~      Risks of the study include risk of rejection and infection after being transplanted.~     Additional risk are associated with procedures that include blood draws, biopsies, x-rays,~     and potential loss of confidentiality. All patient data will be kept electronically and in~     accordance with the requirements of Duke University. In addition to the experimental data,~     this database includes recipient and donor demographics and transplant relevant medical~     history, range of motion, sensation, and immunosuppressive medications. Data will be~     recorded and reported in accordance with the standards required by the United Network for~     Organ Sharing (UNOS).~   "
57012|NCT02310854|"~     To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic~     intraligamentary stabilization and microfracture of the femoral notch, results in at least~     equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms~     of functional recovery one year postoperatively in terms of a patient self-reported outcome~     related to be able to conduct daily and sporting activities. Secondary, the evaluation of~     clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation~     time required for return to daily and sporting activities and levels of sporting activity~     which has returned in patients with status after an ACL rupture and suture repair augmented~     with a dynamic intraligamentary microfracture and stabilization of the femoral notch in~     comparison with an anterior cruciate ligament reconstruction with the ipsilateral hamstring~     graft.~   "
57013|NCT02310841|"~     This pilot study investigates the feasibility of novel control strategies for actuated~     transfemoral prostheses. Several parameters from gait analysis (including motion-capture and~     ground reaction force measurements) are analyzed. The subjective perception of prosthetic~     functionality is captured with a questionnaire.~   "
57014|NCT02310828|"~     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine~     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)~     the attacks of cluster headache.~   "
57015|NCT02310815|"~     This is a prospective multicenter observational post-approval registry study that will~     collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events~     for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a~     broad group of physicians under commercial use conditions.~   "
57019|NCT02310763|"~     This is a Phase 2 randomized, 2-period, double-blind, placebo-controlled, multiple ascending~     dose study to evaluate the safety, efficacy, PK and PD of PF-06252616 administered to~     ambulatory boys diagnosed with Duchenne Muscular Dystrophy. Three intravenous (IV) dose~     levels will be investigated in a within subject dose escalating fashion. Subjects will be~     randomly assigned to 1 of 3 sequence groups for approximately 96 weeks (2 periods of 48~     weeks each). In period 1, two of the sequence groups will receive PF-06252616 and one~     sequence group will receive placebo. In period 2, the placebo group will switch to~     PF-06252616 and the two remaining sequence groups will either receive placebo or~     PF-06252616. Efficacy will be based on an observed mean change from baseline on function (4~     stair climb) of PF-06252616 as compared to the placebo at the end of period 1. Period 2~     provides an opportunity to evaluate PK. Subjects will receive monthly IV infused doses of~     either PF-06252616 or placebo and will undergo safety evaluations (Laboratory, cardiac~     monitoring, physical exams, x-ray, MRI), functional evaluations (pulmonary function testing,~     4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper~     limb functional testing and the six minute walk test), pharmacokinetic testing and~     pharmacodynamic testing to evaluate changes in muscle volume (MRI).~   "
57020|NCT02310750|"~     The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when~     administered to humans. A secondary purpose is to assess what the body does to PF-06700841~     and to assess what PF-06700841 does to the body when given as single and multiple doses. The~     pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and~     solution/suspension forms).~   "
57021|NCT02310737|"~     The purpose of this study is to compare sharp and blunt fascial entry during caesarean~     section.~   "
57022|NCT02310724|"~     The primary objective of T2P2 is to track the progression of T2D and related comorbidities~     and complications in the TODAY cohort as they transition to young adulthood. We hypothesize~     that:~        -  Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of~          diabetes-related medical complications and comorbidities.~        -  The rapid rate of progression is related to increased insulin resistance characteristic~          of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic~          factors, and obesity itself.~   "
57023|NCT02310711|"~     The proposed study is a single-center, prospective, pilot, observation study to tabulate and~     measure the changes that occur during treatment and healing for breast conserving therapy~     (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of~     breast lumpectomy and healing in order to identify targets for improving BCT. The study will~     be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer~     undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving~     their BCT surgery and will be followed for six months after the BCT surgery. A total of 6~     visits (not including the surgery) are planned.~   "
57024|NCT02310698|"~     Breast tumors are often detected on mammography but may be harder to see in women with dense~     breasts. This is why screening breast ultrasound is sometimes used as another test in women~     with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen~     on regular mammography.~      Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is~     essentially a routine digital mammogram performed after iodine dye (the same that is used~     with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been~     shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this~     study is to compare whether CEDM or screening breast ultrasound is better at detecting~     cancer. Both will be done in this study and compared to one another.~   "
57025|NCT02310685|"~     RATIONALE Controlling cardiovascular risk factors has been proven to be effective in~     prevention and management of cardiovascular disease (CVD). Nonetheless, significant~     treatment gaps have been demonstrated repeatedly in numerous surveys. A recent study of~     Canadian adults filling prescriptions for hypertension or dyslipidemia demonstrated that the~     majority remained overweight and sedentary despite being at risk of developing CVD.~     Medication adherence has been shown to be poor with up to 50% of patients stopping therapy~     after one year.~      Patient-centred care can lead to improved clinical management and patient satisfaction.~     Adherence with prescribed therapy can also be improved if individuals understand the~     importance of their risk factors, are aware of their overall health status and participate~     in decision making surrounding pharmacotherapy and lifestyle changes.~      Community pharmacists are frontline healthcare professionals who can identify patients at~     risk of CVD, assess their adherence with recommended lifestyle behaviours or drug therapy~     and engage them in shared decision making surrounding health promotion strategies. Local~     pharmacies could effectively become readily accessible community health centres nationwide.~      Research Objectives. The primary objective is to evaluate, in a randomized clinical trial,~     the impact of a community pharmacy intervention to improve the management of cardiovascular~     risk factors vs a basic e-health education program. The intervention will include a~     cardiovascular or cardiometabolic risk assessment providing the individual with their~     Cardiovascular or Cardiometabolic Age. Individuals at increased risk of CVD and/or with~     modifiable risk factors will also be offered a one year subscription to a multidisciplinary,~     pharmacy based, e-health promotion program to improve management of CVD risk factors such as~     weight loss and increased physical activity and track their progress in managing their risk~     factors and reducing their Cardiovascular or cardiometabolic Age. Changes in CVD risk~     factors, Cardiovascular/cardiometabolic Age, and uptake or adherence to medications and~     lifestyle changes will be examined 3 months, 6 months and one year post intervention.~      Study Hypothesis. Investigators hypothesize that engaging patients in a discussion of their~     Cardiovascular or Cardiometabolic Age and management of their risk factors will result in~     improved healthy lifestyle habits moreover increased physical activity and weight loss.~   "
57026|NCT02310672|"~     The study evaluates the effect of macitentan on right ventricular and hemodynamic properties~     in patients with symptomatic pulmonary arterial hypertension. Patients are treated with~     macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and~     Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and~     Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each~     patient can participate in no sub-study or in one sub-study. The sub-studies are: (1)~     metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the~     RHC); (3) Echo sub-study.~   "
57027|NCT02310659|"~     Coronary artery calcification (CAC) is a pandemic condition in elderly patients with~     coronary artery disease (CAD) and associated with worse prognosis. Although available data~     shows association between testosterone levels in men and CAD, the association between~     testosterone and CAC in old-aged male patients with CAD remains unknown. In this study, the~     relationship of serum testosterone levels with CAC score in elderly male patients with CAD~     was evaluated.~   "
57028|NCT02310646|"~     To gather insight on how product attributes affect usability by investigating the factors~     that are thought to influence patient preference to topical anti-psoriatic treatments.~   "
57087|NCT02309879|"~     This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium~     sulphate and remifentanil in patients undergoing mastectomy~   "
57029|NCT02310633|"~     Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation~     Research & Development (RR&D) and represents a critically important public health problem~     facing the Veteran population. Developing efficacious treatments for persistent memory~     deficits seen in this population is a key step in reducing the impact that such problems~     have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite~     heterogeneous, and efficacy will likely be maximized by developing and disseminating~     multiple alternative treatments individually matched to the Veteran's key deficits, and by~     research that seeks to understand the cognitive and neural basis of treatment-related change~     over time. The results of this approach may aid clinical decision making and assignment of~     patients to rehabilitative treatments most likely to improve memory capacity and functional~     outcome.~   "
57030|NCT02310620|"~     The aim of the study is to show that regular playing with the logic games developed in the~     framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent~     mild cognitive impairment (MCI) and dementia.~      The secondary aim of the study is to find correlations between the results of the games and~     the standard assessments for dementia and MCI screening such as the Rey Verbal Learning~     Test.~   "
57031|NCT02310607|"~     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence~     non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established~     indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc~     protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an~     elevated risk of iron deficiency. The results from the non-invasive measurements are~     compared to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from~     residual blood samples from the same patients and to other indicators of iron status,~     including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble~     transferrin receptor.~      Funding Source - Nestec Ltd.~   "
57032|NCT02310594|"~     This research trial studies the effect of radiation therapy on tumor immunity. Standard~     radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation~     therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this~     response is often ineffective in shrinking tumor tissue. Collecting samples of blood from~     patients before, during, and after radiation therapy to study in the laboratory may help~     doctors learn more about the effects of radiation therapy on anti-tumor response.~   "
57033|NCT02310581|"~     This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group,~     placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of~     Buprenorphine Sublingual Spray and/or matching placebo in subjects with moderate to severe~     postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening~     Period, the Surgical Period, the Treatment Period, and the Follow-up Period.~      Subjects will be admitted to the study site on the morning of the scheduled surgery, will~     remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),~     and will return for the Follow-up Visit 5 to 9 days after surgery.~   "
57034|NCT02310568|"~     This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of~     sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week~     treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use~     the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for~     two doses of PF-06372865 compared to placebo.~   "
57035|NCT02310555|"~     The aim of this study is to compare clinical and laboratory findings of three surgical~     techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI>~     30).~   "
57036|NCT02310542|"~     A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not~     cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove~     those substances. Albumin dialysis with recirculation (MARS) is the most used system but~     required specific system and expert environment. Alternative system without recirculation~     (SPAD) is less expensive and can be realised in critical care services trained to extrarenal~     epuration. The primary objective of this study is to compare biological and clinical~     efficacy, pulsatility index of middle cerebral artery modification and tolerance of both~     systems.~      This is a prospective, open, cross-over comparative study of two albumin dialysis system.~     Each patient will receive the two systems in an randomly assessed order. Patients are~     divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).~   "
57037|NCT02310529|"~     Depression related to pregnancy frequently presents postpartum depression, which has~     deteriorating and lasting negative effects, not only on infant and child well being but also~     on mother's and father's mental health (Nancy K et al 2009). It is therefore important to~     introduce interventions aiming to improve mental health of mothers that could minimize the~     risk of diseases, and have positive effect child's on physical and psychological~     developmental wellbeing.~      Therefore, this project has been designed to assess the effectiveness of Interpersonal~     Psychotherapy for Postnatal Depression in Pakistan.~   "
57045|NCT02310425|"~     Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial~     infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of~     probiotics on growth and development in premature infants have been investigated poorly.~     Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast.~      Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to~     bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce~     feeding intolerance, and had no adverse effects.~   "
57046|NCT02310412|"~     The objective of this study is to test the hypothesis that INTERCEPT platelet components~     stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion~     recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and~     65% InterSol or stored in 100% plasma, will be measured in comparison to fresh~     radiolabeled platelets according to FDA guidance for platelet testing (FDA 1999).~   "
57101|NCT02309697|"~     This study will utilize two validated tools for assessing child development and behavior, to~     investigate the outcomes for children born preterm compared with those born at full term.~     Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital~     will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire,~     and which will assess development in an examination administered by a trained occupational~     therapist at Mount Sinai Hospital.~   "
57038|NCT02310516|"~     The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy~     surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor~     functions, languages and cognitive to better respect them. Indeed, the interindividual~     anatomo-functional variations, the lack of specificity of functional explorations~     radiological magnetic or nuclear, as well as the reorganization of the areas involved in~     these functions (mechanisms of brain plasticity) in epileptic patients or patients with~     cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows~     an analysis and a precise real-time identification of areas and networks involved in these~     functions through a direct electrical stimulation (inhibitory or activatory). Thus, this~     surgical technique has become a gold standard in surgery of brain lesions located in~     functional areas.~      However, although the brain awake surgery has been practiced since many years, the~     confidentiality of these informations until recent years explains probably that very little~     data to be available on the personal experience of this procedure by patients. Studies that~     have analyzed the perception of the patient or the satisfaction of the patient after surgery~     in awake conditions were retrospective and included few patients. The investigators~     experience of lived of this surgery that the investigators have developed in the~     investigators team since over four years is that on the whole awake surgery is well~     tolerated if adequate explanations are provided preoperatively and if a minimum of~     preoperative precautions are observed.~      Thus, the investigators have decided to develop a preoperative device that could improve~     personal experience and well-being of patients undergoing this surgical approach.~   "
57039|NCT02310503|"~     REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs~     surgery, and patient, tumor and technique factors related to adverse events and tumor~     recurrence.~      REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in~     participating centers. All consecutive patients are included. The only exclusion criteria~     are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by~     common clinical practice, but at least once a year for the study period.~   "
57040|NCT02310490|"~     Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter~     clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the~     treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive~     DermaVeil and SCULPTRA on either the right or left side of the face.~   "
57041|NCT02310477|"~     This is a largest cohort study aimed to estimate the overall survival of patients been~     treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a~     french compassionate program.~   "
57042|NCT02310464|"~     The primary purpose of the clinical trial is to investigate safety and tolerability of~     escalating doses of OBI-833/OBI-821 in subjects with metastatic incurable solid tumors, such~     as gastric, lung,colorectal or breast cancer. Meanwhile, the tumor response and humoral~     immune responses, i.e.,anti-Globo H IgG and IgM production following administration of~     OBI-833/OBI-821 will be assessed as the secondary objective of this study.~   "
57043|NCT02310451|"~     Recent progresses have been made in the treatment of metastatic melanoma, nevertheless~     improved patient survival is still limited because of primary resistance and relapses. It is~     therefore important to continue to understand the molecular mechanisms involved in melanoma~     development and progression to improve the management of patients.~      Drugs such as the alkylating agents (temozolomide and fotemustine) or vemurafenib trigger~     senescence-like phenotypes in melanoma cells. It is now known that senescent cells secrete~     some factors that exert a pro-tumoral role but the potential existence and the role of~     insoluble factors remain undetermined.~      Preliminary results from the investigators laboratory indicate the presence in the senescent~     secretome of exosomes; microvesicles involved in intercellular communication,~     immunomodulatory functions, and tumorigenesis. Several studies showed that these vesicles~     shape the tumor microenvironment and contribute to the migration of cancer cells.~      Their interest in oncology as a prognostic factor and marker of therapeutic response is~     increasing.~      Thus, our project aims to study the effect of exosomes produced by senescent melanoma cells~     in the development and progression of melanoma in vitro and in vivo using cell cultures and~     animal models.~      In addition, the investigator propose a pilot study whose objective is to determine the~     effect of vemurafenib on nanovesicles produced by patients with advanced unresectable or~     metastatic melanoma.~      The investigator hope to show that exosomes participate in the process of drug resistance~     and relapse, with the goal of developing (with the exosomes study) theranostic tools for~     personalized care in patients.~   "
57044|NCT02310438|"~     Impairment of arm function is more common than lower limb impairment in stroke patients and~     is also more resistant to treatment. Several clinical trials with stroke patients have~     produced statistically significant gains in upper limb function when using instrumental~     playing and treatments where rhythm supports the priming and timing of movements. Based on~     the positive results from controlled and non-controlled trials, the Cochrane review of music~     therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation~     into rhythm based techniques to treat hemiparesis in stroke patients, and that future~     studies need to examine the relationship between the frequency and duration of interventions~     and treatment effects.~      The aim of this study is to examine whether or not a thirty minute, twice weekly, six week,~     home music therapy treatment, playing set musical patterns on instruments to music is~     feasible to deliver, and will lead to improved coordination, dexterity and activities of~     daily living in hemiparetic stroke patients.~      Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who~     are between one month and two years post stroke with hemiparesis. Participants will have~     completed and been discharged from community rehabilitation for their upper limb and not be~     receiving any other treatment for arm function. They will be randomised into two groups:~     treatment (for immediate treatment following discharge from community rehab) and waiting~     list (beginning 9 weeks after baseline measure). Participants will be assessed at the~     beginning and end of treatment (just before starting and just after completing 6 weeks of~     treatment) by one of two experienced community occupational therapists under contract with~     CCS, who are also experienced in working with stroke patients and who will be blind to the~     experiment. The other three measures will be conducted by the chief investigator. The~     assessment tools will be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT).~     There will also be a pre and post treatment semi-structured interview for each participant,~     which will be conducted by the chief investigator. ARAT and 9HPT assessments will be~     administered to all participants at the same time points: baseline and then at week 6, 9, 15~     and 18. Data will be analysed to determine if the treatment is effective compared to no~     treatment (wait list) following community discharge, and whether earlier intervention~     (treatment group) yields better results for participants, all of whom will eventually~     receive treatment.~   "
57083|NCT02309931|"~     The study will provide a precise control compared to the two interventions (iso vs~     antiperistaltic anastomoses) with thorough measurements of the postoperative variables and~     complications to improve the evaluation of the surgical technique. It will also enable an~     evaluation of the quality of life after the procedures.~   "
57047|NCT02310399|"~     This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be~     conducted as a repeated-measures, single subject experiment in order to accommodate the~     known variability in cochlear implant clinical results. Data obtained in the course of this~     study will be compared with the existing published outcome data from children with normal~     hearing and with cochlear implants (CIs). These comparisons may provide additional useful~     information about the progress of ABI subjects' performance over time. Also, this may allow~     the results of the current study to be utilized to design future pivotal studies of the~     device in the pediatric population.~   "
57048|NCT02310386|"~     Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes~     considerable costs in primary health care setting as well as specialized medical care~     sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving~     effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is~     sparse knowledge about the effects of long-term RCTs in the treatment of pain in~     fibromyalgia, as there are no publications about cost-effectiveness analysis of such~     treatments.~      The aim of this study is to investigate whether the BEMER electromagnetic field therapy~     device has beneficial long-term effects in the treatment of pain, and whether it improves~     fibromyalgia patients' quality of life. In addition, this study investigates whether the~     BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.~   "
57049|NCT02310373|"~     This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones)~     smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking~     is known to transiently increase blood pressure and heart rate while decreasing heart rate~     variability suggesting - but not proving - sympathetic mediation. The contribution of~     nicotine to these effects is unknown. Here the investigators will directly measure the acute~     effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography~     (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.~   "
57050|NCT02310360|"~     The purpose of this study is to investigate whether a combination of taste probes and~     food-related cues can induce dopamine release in striatal and extra-striatal brain regions~     in healthy subjects.~   "
57051|NCT02310347|"~     The purpose of this study is to examine the influence of a medicinal cannabinoid agonist~     versus placebo on behavioural and gut peptide responses to food images and food intake.~   "
57052|NCT02310334|"~     The objectives of this study are to demonstrate that real time physiological status~     monitoring and the use of optimization techniques during exercise can have a positive impact~     on physiological status, and to collect metabolic flexibility profiles of young fit adults~     during rest and exercise.~   "
57053|NCT02310321|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or~     recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as~     induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in~     newly Diagnosed Acute Myeloid Leukemia (AML). Safety and tolerability of ASP2215 will also~     be evaluated. This study will also characterize the pharmacokinetic (PK) parameters of~     ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluate the PK~     parameters of cytarabine concomitant with ASP2215.~   "
57054|NCT02310308|"~     The effect of chewing gums containing MBE and xylitol on different variables related to~     caries and gingivitis in a sample of adult volunteers with a high risk for caries will be~     evaluated. The main result of that double-blind randomized controlled interventional trial~     will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity,~     salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and~     sugar-free chewing gum.~   "
57055|NCT02310295|"~     Purpose: To compare the effects of macular photocoagulation with or without intravitreal~     bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME).~     Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive~     either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16)~     or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected~     visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were~     performed at baseline and monthly for 12 months.~   "
57056|NCT02310282|"~     Observational prospective single-center study on the discriminatory value of the Unassisted~     TeleStroke Scale for differentiation between patients with lacunar stroke and those with~     other acute stroke syndromes.~   "
57057|NCT02310269|"~     This is a non-interventional, multinational, multi-center post-marketing study, to further~     document the safety and efficacy of pasireotide s.c. administered in routine clinical~     practice in patients with Cushing's disease. Patients with Cushing's disease and treated~     with pasireotide s.c. alone and in combination with other therapies will be monitored. For~     this study, each enrolled patient will be followed up for 3 years after enrollment. Patients~     who permanently discontinue pasireotide s.c. prior to completing the 3-year observation~     period will be followed up for 3 months after the last dose of pasireotide s.c.~   "
57058|NCT02310256|"~     The aim of the study is to evaluate whether walking capacity in patients with intermittent~     claudication is improved more by home-based 5+ exercise training than by current~     recommendations of daily walking. The study will elucidate if such a potential effect is~     dependent on changes in mitochondrial respiratory capacity, blood flow or both.~   "
57059|NCT02310243|"~     Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age~     limit Study drug: Palbociclib Phase Ib/IIa, open-label~        -  Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days~          followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell~          lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and~          glioblastoma, this regimen will be chosen for the first dose to be evaluated in the~          phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib~          for the phase IIa is defined.~        -  Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib~          part of the study is administered once daily for 21 days followed by 7 days of rest.~          Based on the optimal two-stage design of Simon, 21 patients are treated in the first~          stage. If results are positive, 29 additional patients will be recruited into the~          second stage of the study. An efficacy of the investigational therapy will be rejected~          in the first stage of 21 treated patients if two or less patients achieve complete~          remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR),~          or anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE~          during this first stage, the trial is intended to be continued in the second stage with~          a total sample size of 50 patients.~      Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient~     out): July 2018 The treatment duration of an individual patient is estimated to be 2-6~     months, but may be unlimited in patients with sustained response (case-by-case decision).~      Observation time per patient after entry into the study (incl. treatment) is at least 12~     months.~   "
57060|NCT02310230|"~     Purpose: To assess the utility of a new medical device that monitors a patient's breathing~     during medical procedures in which a patient is sedated, but not mechanically ventilated. In~     minor procedures, such as endoscopy (where the doctor examines a patient's digestive tract~     by a TV camera inserted through the mouth), patients do not require general anesthesia, in~     which a machine would take over their breathing while they are unconscious for surgery.~     However, during endoscopic procedures it is sometimes difficult for the anesthesiologist to~     monitor the patient's breathing—specifically, to monitor changes in breathing patterns and~     the adequacy of breathing. In endoscopy procedures, the room is darkened, and the patient's~     mouth is generally occupied by the endoscope. While the anesthesiologist can listen to the~     patient's breathing sounds with a stethoscope, this type of monitoring can only be done~     periodically, and there is limited ability to gauge the adequacy of ventilation. This study~     will use the ExSpiron Respiratory Volume Monitor (RVM), which measures non-invasive minute~     ventilation (MV), tidal volume (TV) and respiratory rate (RR), in patients undergoing an~     endoscopic procedure to provide additional information regarding the effects of clinical~     interventions such as drug administrations or airway maneuvers on the patient's respiratory~     status.~      For patients who give informed consent, study participation means that they will have a~     PadSet consisting of 3 electrodes applied to the chest. Another component, a nasal cannula~     (a thin clear plastic tube that goes under the nose) will give patients supplemental oxygen,~     and is standard of care for endoscopy at UVM Medical Center. Patients will then be asked to~     breathe in and out of a portable spirometer (breath meter) for 30 seconds up to five times.~     This data will be compared to data recorded by the monitor to confirm that the monitor is~     recording accurately. The procedure will then go forward in the normal fashion. Patients~     will be randomly placed into one of two groups. In the first group during the procedure, the~     anesthesiologist will not be able to see the numbers (MV, TV, and RR) displayed screen of~     the monitor, so the data will not be used to guide the patient's clinical care. In the~     second group, the anesthesiologist will be able to see the RVM measurements of MV, TV, and~     RR to evaluate the effect of the interventions. Monitoring for both groups will continue in~     the recovery room, until discharge.~   "
57061|NCT02310217|"~     The relationship among hypertension, aging and cognitive decline is complex and not~     completely understood. Purpose of this project will be evaluating early markers of cognitive~     deterioration in patients with arterial hypertension. In particular, this cross-sectional~     observational study will be articulated in three phases:~        1. Neuropsychological evaluation of general cognitive abilities~        2. Identification and measurement of specific biomarker levels~        3. Correlation among hypertension, cognitive abilities and biomarkers.~   "
57062|NCT02310204|"~     The primary objective of this research protocol is to assess the effect of a structured~     therapeutic education program on the quality of life of patients with moderate to severe~     psoriasis~   "
57063|NCT02310191|"~     New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery~     stenting (CAS). The aim was to assess correlation between selected laboratory markers and~     occurrence of new brain infarctions after CAS.~   "
57064|NCT02310178|"~     The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by~     several types of bariatric procedures. In addition, this study could lead to the development~     of clinical trials on assessment of the bariatric surgery impact.~   "
57065|NCT02310165|"~     The purpose of this study is to compare two different methods that are used for inserting~     the needle during paracentesis. One method is called the coaxial insertion technique and~     the other is called the z-tract technique. Researchers would like to see which method is~     better and leads to less problems like oozing from the needle insertion site and pain during~     the procedure. Both methods are approved and currently used methods for doing a paracentesis~     at the University of Virginia. Which method is used generally depends on physician~     preference. There have been no studies done to date that compare these two methods for~     needle insertion.~   "
57066|NCT02310152|"~     Childhood anxiety disorders are very common, carry tremendous personal and societal costs,~     frequently do not respond adequately to treatment, and involving parents in treatment has so~     far not enhanced outcomes. Explanatory clinical trials are needed to identify parent~     specific mechanisms of change that are not targeted in direct child treatment, and to~     identify markers of who is most likely to benefit from parent intervention. This study is an~     explanatory clinical trial of a parent based intervention and of cognitive behavioral~     therapy, and an investigation of biological and behavioral moderators of treatment response.~   "
57067|NCT02310139|"~     Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal~     disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this~     removal is also known as polypectomy.~      Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying~     from it. Colonoscopy can be challenging due to technical or patient factors. In a small~     proportion of patients a complete colonoscopy is unsuccessful. Such patients either get~     referred to a tertiary centre with extensive experience in difficult colonoscopy or have an~     alternative test such as CT scan. The investigators unit has accumulated significant~     experience related to previously failed colonoscopy and anecdotally appears to have a high~     success rate in completing the procedure.~      The purpose of this project is to describe the investigators technical approach to~     management of patients with previously failed colonoscopy. There is no additional~     intervention and the project is observational in nature. The investigators will collect data~     on patient characteristics, the reason for the failure and what technique was used to~     overcome the difficulty. The investigators will also note whether the final outcome of the~     technique had any impact on the overall management of the patient.~   "
57068|NCT02310126|"~     Subjects will evaluate each study lens in a random order. The lenses will be worn in both~     eyes for a short period.~   "
57069|NCT02310113|"~     The aim of the present study was to re-challenge the current data that anaemia in~     chronically anaemic haematology patients is not associated with low skeletal muscle StO2,~     and that the age of RBCs does not influence tissue responses. The investigators investigated~     these aspects using improved technology NIRS devices, for deeper tissue penetration and~     removal of the superficial signal from the skin.~   "
57070|NCT02310100|"~     A prospective, multicenter, interventional study to collect confirmatory evidence on the~     safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post~     approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using~     contact force assisted irrigated radiofrequency ablation.~   "
57071|NCT02310087|"~     The purpose of the study is to determine whether administration of dietary supplement of~     astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo~     development in Assisted Reproduction Techniques (ART) procedures.~   "
57072|NCT02310074|"~     Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex~     development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy~     and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we~     compared the different efficacy and safety of pulsatile GnRH pump therapy with combination~     gonadotropin therapy on fertility and sexual development in male patients with IHH.~   "
57073|NCT02310061|"~     Volume overload is a leading risk factor for death and cardiovascular events in end stage~     renal disease patients maintained on chronic dialysis, particularly in those with myocardial~     ischemia and heart failure which represent a substantial fraction of this population. Early~     identification of volume overload may prevent cardiovascular sequel in these patients but~     clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk~     and to monitor them over time. On the other hand, however reliable, standard techniques for~     measuring extracellular or circulating (blood) volume do not convey information on~     fundamental heart function parameters that determine the individual haemodynamic tolerance~     to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling~     pressure and LV function.~      Extra-vascular lung water is critically dependent on these parameters and represents a proxy~     of both, circulating volume and LV filling pressure and function, and may therefore be a~     better criterion to identify patients at a higher risk of volume-dependent adverse clinical~     outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (<~     5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular~     lung water by using standard ultrasound (US) machines has been validated in dialysis~     patients. Whether systematic measurement of lung water by this technique may translate into~     better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.~      The aim of this randomized clinical trial is that of testing a treatment policy guided by~     extra-vascular lung water measurements by ultrasound to prevent death, decompensated heart~     failure and myocardial infarction as well as progression of Left Ventricular Hypertrophy~     (LVH) and LV dysfunction and hospitalization in high risk dialysis patients with myocardial~     ischemia (a history of myocardial infarction with or without ST elevation or unstable~     angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable~     angina pectoris with documented coronary artery disease by prior coronary angiography or~     ECG) or overt heart failure (NYHA class III-IV).~   "
57074|NCT02310048|"~     The purpose of this study is to assess the comparative oral bioavailability of a Formulation~     B versus the Formulation A of MT-1303.~   "
57075|NCT02310035|"~     Blood sampled for standard evaluation will be used for determination of plasma glutamine by~     Bioprofile Flex Glutamine Sensor at ICU admission~   "
57076|NCT02310022|"~     Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3~     medication comparator.~   "
57077|NCT02310009|"~     Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c>7%) will be assigned to one of~     the 4 following interventions in a randomised, parallel group design: [I] Control (placebo~     injection; no exercise), [II] Anakinra (100 mg subcutaneous injection of human recombinant~     interleukin-1 receptor antagonist), [III] Exercise (1 h cycle ergometry at 75% VO2max), [IV]~     Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be~     measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal~     glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).~   "
57078|NCT02309996|"~     Supervisors of injured workers play a key role in preventing prolonged work absences.~     Providing supervisors with tools to improve their response to musculoskeletal and other~     workplace injuries or illnesses may improve worker health and disability outcomes.~      The primary objective of this research study is to determine the effectiveness of the~     supervisor training program, the SMART Supervisor Training Program, on reducing the total~     duration of workers' lost-time claims. The secondary objectives are 1) to determine the~     effectiveness of the training program on reducing the cumulative incidence of workers'~     lost-time injuries and sick leave days; 2) to determine if implementation of the training~     program is associated with improvements in hypothesized mediating variables, such as~     attitudes toward job accommodations, response to workplace injury, and communication with~     employees and healthcare providers; 3) to investigate the implementation of the training~     program by conducting a process evaluation.~      The investigators hypothesize that:~        1. the duration of lost-time claims for workers working under supervisors receiving the~          training program will be shorter than the duration of lost-time claims for workers with~          supervisors in the control group;~        2. the cumulative incidence of lost-time injuries and sick leave days will be lower in the~          group receiving the training program compared to the control group;~        3. the training program will be associated with increased knowledge, response,~          communication and changed attitudes towards workplace accommodation.~      This research is of significance to North American employers and compensation systems~     because there is a lack of knowledge about the usefulness of supervisor training to prevent~     or reduce work disability. It also has important implications for guiding employer policies~     and practices, and for identifying circumstances where supervisor training should be a~     priority.~   "
57079|NCT02309983|"~     For many after spinal cord injury (SCI) there is immobilization, muscle atrophy, bone loss,~     fracture risk during transferring (or falls), and the risk of secondary complications, and~     increase in attendance care and cost. It is important to develop multi dimensional~     rehabilitation strategies for people after SCI to enhance functional recovery towards~     walking, and enhance an increase in muscle and bone to potentially prepare the injured~     nervous system in the event of a cure. Locomotor training (Stand retraining and step re~     training) an activity-based rehabilitative approach generates muscle activity and provides~     weight bearing and joint contact kinetics, even in individuals who are unable to stand or~     step independently. Cross-sectional animal and human SCI studies have demonstrated that~     locomotor training (LT) (stand retraining and step retraining using body weight support~     treadmill training) has improved the capacity to stand independently and walk at faster~     speeds. Neuromuscular stimulation (NMS) or electrical stimulation (ES) training is a~     rehabilitative approach that generates muscle activity, alternating leg extension and~     flexion even in individuals who are unable to stand or step independently. NMS studies for~     individuals after SCI have shown improvements in bone density and muscle strength after~     cycling and resistance training. The main purpose of this study is to address whether stand~     retraining and NMS compared to stand retraining alone or NMS alone will increase neural and~     musculoskeletal gains and provide a greater functional recovery towards independent~     standing.~      This project will be completed at two sites: Kessler Foundation Research Center (the grant~     PI site) and Frazier Rehabilitation Institute, University of Louisville, Kentucky.~   "
57080|NCT02309970|"~     CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which~     are only partially or insufficiently perfused during an acute ischemic event. The~     differentiation between the core infarct and the still viable penumbra is its major clinical~     application. CTP helps directly in the decision-making process in the event of acute~     ischemic stroke by increasing the potential of success in patient who can benefit from~     thrombolytic/endovascular treatment.~      The use of CTP in patient selection for thrombolytic/endovascular treatment was never~     evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a~     good correlation between the size of the penumbra and the clinical outcome when done in~     early as well as late stages of the event.~      The importance of identifying the penumbra in the acute phase of the ischemic stroke is~     widely accepted. But crucial evidence to support the predictive value of CTP to predict the~     clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.~      Currently, the use of CTP is based on theoretical assumptions and expert opinions but a~     randomized prospective study to validate its use is lacking.~      The current guidelines restrict the use of CTP trials and to patients that can't performed~     MRI scan.~   "
57081|NCT02309957|"~     Prospective, multi-center, non-randomized, historical controlled, post-market study of~     patients requiring surgical repair of a focal articular cartilage lesion or osteochondral~     defect in the knee.~   "
57082|NCT02309944|"~     The purpose of the study is to test whether the use of a new wound closure technique can~     decrease the rates of wound complications in obese cancer patients.~   "
57088|NCT02309866|"~     Retinitis Pigmentosa (RP) is the most common form of hereditary retinal degeneration, with a~     worldwide prevalence of 1:3500. It is one of the most genetically heterogenous conditions in~     humans, with over 100 causative genes and loci reported to date. However, in approximately~     40% of patients the underlying genetic causes are yet to be found.~      The current study aims to identify causative RP genes and mutations in Israeli families of~     various ethnic backgrounds. Identification of such genes will contribute significantly to~     disease prevention (by identification of high risk families and appropriate genetic~     counseling) and to the investigators understanding of retinal structure and function and of~     the etiology of RP.~   "
57089|NCT02309853|"~     The purpose of this study is to evaluate whether 20 Sessions of 30 minutes with a visual and~     tactile scanning training in the personal, peripersonal and extrapersonal space combined~     with trunk rotation will be feasible and provide better results compared to 20 Sessions of~     30 minutes of a standard visual scanning programme.~   "
57090|NCT02309840|"~     The purpose of this study is to examine the impact of introducing healthier, chef-enhanced~     foods and/or environmental modifications (choice architecture) on selection and consumption~     of school foods among elementary and middle school students.~   "
57091|NCT02309827|"~     This study is a first in human study of PF-06651600. PF-06651600 is being developed for~     treatment of inflammatory bowel disease. This study will test single and multiple doses of~     PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics~     and pharmacodynamics of PF-06651600 in healthy volunteers.~   "
57092|NCT02309814|"~     The investigators have developed a simple to use device that facilitates the monitoring of~     the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and~     graphic presentation of the results. the device system consists 3 components : glasses for~     the patient including magneto sensitive probes, hardware and dedicated software.~      Our purpose is to characterize eyelid motion in normal population. The methods include~     measuring each patient 10 minutes during watching a short movie.~   "
57093|NCT02309801|"~     The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2~     (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in~     humans.~   "
57094|NCT02309788|"~     Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in~     Asia, but the five-year relative survival rate is relatively quite low1-3. As a common~     complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an~     occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem~     for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their~     clinical features or liver function4. For HCC PVTT treatment, current options are surgical~     resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy,~     biological and gene therapy,etc. Among them, the use of radiation therapy is getting more~     and more attention, and it is changing from the past palliative treatment to current curable~     treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often~     associated with higher rates of recurrence and shorter patient survival.On the other hand,~     it is also believed that most intrahepatic recurrences arise from multicentric~     carcinogenesis and are distant from the resection margin.To address this issue, the~     investigators are going to conduct a series of retrospective and prospective studies to~     investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm)~     hepatectomy on tumor recurrence.~   "
57095|NCT02309775|"~     Objectives: Verify the effect of auriculotherapy in patients with tension-type headache~     resulting from temporomandibular dysfunction.~      Design: Randomized clinical study Setting: Randomized Study Participants: The study consist~     of 38 participants randomized into two groups: an intervention group (n = 18, sample loss =~     1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will~     receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic,~     Subcortex, Adrenal and Cerebral points. The placebo group will receive auriculotherapy in~     the trachea point.~      Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography~     (EMG).~   "
57096|NCT02309762|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     immunogenicity of single-ascending IV doses of FB825~   "
57097|NCT02309749|"~     This is a pilot to review the feasibility of a program that assists patients towards therapy~     compliance by scheduled intervention through the first month of therapy. The hypothesis of~     this study is that the trial program will function as intended and average patient adherence~     will be over 4 hours per night.~   "
57098|NCT02309736|"~     This is a prospective multicenter observational single arm post-approval registry that will~     collect post-approval data relative to the incidence of endophthalmitis for cataract surgery~     patients treated with the FDA-approved ReSure Sealant when used by a broad group of~     physicians under commercial use conditions.~   "
57099|NCT02309723|"~     When older patients develop cognitive problems - like memory loss - there may be any of~     several underlying causes, sometimes occurring in combination. Clinicians have a better~     chance of providing appropriate treatment if they understand what the cause of the problem~     is. A diagnostic tool can help the patient by helping the clinician to make a more accurate~     diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging -~     may potentially improve medical practice. The tool can potentially improve practice only if~     it can influence clinical judgment. This study investigates whether the provision of beta~     amyloid imaging information influences clinical judgment. The investigators will conduct a~     survey that presents clinicians with descriptions of hypothetical older patients with~     cognitive complaints. Some of the respondents also receive beta amyloid imaging information.~     The investigators will test the investigators hypothesis that the information will affect~     diagnostic judgment and management recommendations by comparing the responses of clinicians~     who receive the beta amyloid information to the responses of clinicians who do not.~   "
57100|NCT02309710|"~     This prospective study will evaluate the safety and acceptability of the ShangRing device~     for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi~   "
57102|NCT02309684|"~     The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing~     and compare its performance with the standard of care at NFRMC Wound Therapy Services, for~     the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open~     one-arm clinical study.~   "
57106|NCT02309632|"~     100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes~     associated with increased risk of pancreatic cancer, will be followed for five years. This~     data will be used to determine the pancreatic cancer and precancerous lesion detection rate~     in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers~     or to biomarkers only.~   "
57107|NCT02309619|"~     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of~     cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and~     effective management for resectable EC. Gastric tube is considered to be an ideal substitute~     for the resected esophagus and can be lifted to the neck for anastomosis through two~     different paths — Trans-substernal and trans-esophageal bed routes. However, the differences~     of operative outcomes between the two paths have not been systematically described. In this~     study, clinical outcomes including intra- and post-operative status, morbidity and~     complications, nutrition status, as well as quality of life after surgery will be evaluated,~     and differences between the trans-substernal and trans-esophageal bed groups will be~     compared. The study might help to individualization treatment for EC.~   "
57108|NCT02309606|"~     Migraine affects 16% of the world population and is one of the most disabling of all~     disorders. It is a complex brain disorder characterized primarily by recurrent headache~     attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been~     thought to play a central role in migraine pathophysiology. The most effective class of~     abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific~     actions of serotonin and the mechanisms of triptans are still unknown. In this project the~     investigators will use high-resolution positron emission tomography and specific~     radioligands to investigate the significance of serotonin in migraine. Two newly developed~     radioligands that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be~     applied. To investigate the level and distribution of serotonin in the migraine brain the~     investigators will compare the binding of these ligands in episodic migraine patients with~     healthy controls. In addition, the investigators will include chronic migraine patients to~     evaluate the relation between the level of serotonin in the brain and the frequency of~     migraine attacks. To investigate the changes in the serotonin level during a migraine attack~     and the effects of triptans on the central nervous system the investigators will repeat the~     scans using the 5-HT1B specific ligand during induced migraine attacks and following~     treatment with sumatriptan. The results from this study will shed light on the role of~     serotonin in the migraine brain and elucidate the migraine-specific action of triptans. This~     will improve our understanding of the migraine pathophysiology and, potentially, facilitate~     the development of more efficient treatment of migraine.~   "
57109|NCT02309593|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study~     to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
57110|NCT02309580|"~     This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1~     clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with~     T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this~     phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see~     what effect the drug has on the patient and the disease.~   "
57111|NCT02309567|"~     p53 is a tumor suppressor gene which plays an important role in controlling normal cell~     proliferation regulation that is located on the chromosome 17 (17p13.1). It is the most~     common goal of genetic alteration in many tumors. Serum p53 protein is presence in normal~     healthy individuals. However p53 antibody is extremely rare. Mutations in this gene cause an~     accumulation of non-functional proteins and development of anti-p53 antibodies, which can be~     detectable in tissues, slouhed cells, blood and other body fluids. Some studies have~     reported that, p53 mutations are highly common in leukemia, lymphoma, lung, esophagus,~     stomach, liver, bone, bladder, ovarian, and brain cancers. Lung cancer is the most common~     cause of cancer-related deaths and the survey is low after the initial diagnosis. Accurate~     staging is important for determine the choice of treatment and predict prognosis. 18F-FDG~     PET/BT has important value for initial staging and it is the most advanced imaging technique~     developed all over the world for determine of the characterization of the metabolic tumor~     volume. Maksimum Standardized Uptake Value (SUVmax) which was acquired by PET imaging is~     commonly used in clinical practice as a criterion for malignancy. Due to the development of~     new software programs recently studies have shown that metabolic tumor volume (MTV) and~     total lesion glycolysis (TLG) may be useful quantitative parameters for the prognostic~     evaluation. Viable tumor volume could be estimate with this programs.The purpose of this~     study was to assess the relation between serum anti-p53 antibody level and quantitative PET~     parameters as SUVmax, SUVave, MTV and TLG.~   "
57112|NCT02309554|"~     This post coital test study is a Phase I multi-center, randomized, crossover,~     non-significant risk device study to be carried out at two clinical sites/centers. The~     products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide),~     the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be~     randomized to the order of product use, with a goal of 10 participants completing the study.~   "
57113|NCT02309541|"~     The purpose of this study is to evaluate audio quality benefit for the patient implanted~     with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller~     algorithm) whatever the patient environment is and to evaluate the functional gain and~     speech understanding benefit for the patient upon the firmware used (new and reference~     firmware). The new firmware aims to adapt automatically for feedback cancellation without~     prior calibration.~   "
57127|NCT02309359|"~     The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061~     administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with~     active RA despite MTX therapy, compared with placebo.~      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK),~     pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose~     regimen for ALX-0061, based on safety and efficacy, for further clinical development.~   "
57114|NCT02309528|"~     Few educational intervention clinical trials have been conducted among those at risk for or~     with early chronic kidney disease. To the investigators' knowledge none have used digital~     storytelling as a means to deliver the educational message and have been conducted among~     American Indians, a group with high prevalence of chronic kidney disease and end stage~     kidney disease.~      The aims of the research project are to:~        1. Quantify levels of chronic kidney disease knowledge and awareness among American~          Indians.~        2. Determine the effectiveness of a culturally tailored health presentation with~          computerized digital stories made by American Indians for improving chronic kidney~          disease knowledge and factors thought to be preventative of chronic kidney disease or~          its progression at baseline and follow-up in a pilot educational clinical intervention~          trial.~   "
57115|NCT02309515|"~     This randomized phase II trial studies how well lenalidomide improves immune response to~     pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia,~     small lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such~     as lenalidomide, use substances made from living organisms that may stimulate or suppress~     the immune system in different ways and stop cancer cells from growing. Lenalidomide may~     also improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to~     prevent infection.~   "
57116|NCT02309502|"~     Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to~     65 years worldwide.~      Patients with DR may go on to develop a more severe form of the disease called Proliferative~     Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and~     bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal~     photocoagulation (laser treatment) is usually recommended.~      The purpose of the investigators study is to find if treating patients using a single~     session of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an~     earlier stage in Diabetic Retinopathy (during the severe non-proliferative diabetic~     retinopathy stage) when the abnormal new vessels are not developed, will prevent diabetic~     patients to develop PDR.~      Patients included in the study will be randomized in three arms (randomization). In one arm~     patients will be treated with the normal parameters used in Pascal® laser, the second arm~     patients will be treated with a lower intensity than normal, using the Endpoint management~     system (a new software from the Pascal® laser which allow us to decrees the intensity of the~     burns (invisible burns) showing some landmarks with normal intensity so the area which has~     been treated can be viewed. And in the third arm the patients will be observed.~   "
57117|NCT02309489|"~     The uptake of postpartum contraception, postpartum care attendance and the practice of~     exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in~     maternity care has been shown to be a promising strategy for the achievement of other~     reproductive health goals, little is known about the effect of their participation on these~     outcomes. This study aims to test whether the involvement of men can improve care-seeking~     and promote healthy behaviours among postpartum women in Burkina Faso.~   "
57118|NCT02309476|"~     Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us~     to decrease the intensity of the burns (invisible burns) showing some landmarks with normal~     intensity so the investigators can see the area which has been treated. The Pascal® system~     with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was~     utilized in previous Pascal® laser studies.~      This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and~     effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.~   "
57119|NCT02309463|"~     The objective of the study is to monitor physical activity longitudinally with a wrist~     activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the~     correlation with the 6MWD at different time points. Further objectives are to assess the~     correlation of physical activity measured with the tracker and other parameters for clinical~     evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class,~     hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy~     in PAH patients newly initiating ERA therapy.~   "
57120|NCT02309450|"~     ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with~     Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of~     pegylated Interferon-Ribavirin regimen.~      Proportion of patients with cirrhosis will be limited to 50% of all patients included,~     cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse~     elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.~   "
57121|NCT02309437|"~     The present study is a superiority research, to evaluate the nutrition status, quality of~     life, influence on clinical outcome, and the adverse effects of the early use of OxyContin~     on the pain induced by radiation oral mucositis in nasopharyngeal carcinoma patients.~   "
57122|NCT02309424|"~     This open, randomized, cross-over, placebo-controlled study aims to investigate the effects~     of vinegar on glucose metabolism, endothelial function and circulating lipid levels in~     subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous~     difference technique.~   "
57123|NCT02309411|"~     The purpose of this study is to find out whether rivaroxaban is safe to use in children and~     how long it stays in the body. Safety will be assessed by looking at the incidence and types~     of bleeding events. There will also be a check for worsening of blood clots.~   "
57124|NCT02309398|"~     The purpose of this study is to develop and implement quality improvement programs for the~     treatment of atrial fibrillation (AF) in China based on the successful experience of the~     AHA‐Get with the Guidelines program. This two-year program will use data collection,~     analysis, feedback, and process improvement to extend the use of evidence-based guidelines~     throughout the healthcare system and improve patient care of atrial fibrillation.~   "
57125|NCT02309385|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in~     patients with acute anterior uveitis.~   "
57126|NCT02309372|"~     This trial will determine if depression treatment will reduce cardiovascular risk in~     HIV-infected patients already receiving HIV treatments. Half of the participants will~     undergo a specific computerized depression treatment with the other half receiving usual~     care from their HIV providers.~   "
57129|NCT02309333|"~     Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare,~     many doctors do not have experience treating it. APL has been shown to be curable most of~     the time. Unfortunately, some patients die early after they become sick with APL, sometimes~     even before starting treatment. The early period is from the time of diagnosis through the~     first treatments for the disease. This is approximately 30 days. Early deaths are often due~     to complications caused by of the effects of leukemia and the treatments of it. These~     complications may not be noticed quickly by doctors who don't have much experience with~     managing APL.~      The purpose of this study is to collect information about the diagnosis and management of~     APL patients by review of their medical records. This information will be stored in a~     central database at Emory University. This data will be analyzed to discover the impact of~     increased physician knowledge of recommended management of APL. The goal is to reduce the~     events of early death of APL patients.~   "
57130|NCT02309320|"~     The primary objective of the study is to investigate the safety and tolerability of~     ALX-0171.~      The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the~     pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.~   "
57131|NCT02309307|"~     The VergenixTM STR device is intended for the repair of non ruptured tendon injuries~     (Tendinopathy).~   "
57132|NCT02309294|"~     The objective of this study is to determine the ability of the study material to cause~     irritation to the skin of humans under controlled patch test conditions. Substances that~     come into contact with human skin need to be evaluated for their propensity to irritate~     and/or sensitize. This testing is a modified primary irritancy patch test that can detect~     weak irritants that require multiple applications to cause a skin reaction.~   "
57133|NCT02309281|"~     Title: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular~     degeneration with limited response to ranibizumab~      Purpose: The purpose of this investigator initiated study is to identify the duration of~     treatment effects of intravitreal aflibercept on sub- and intraretinal fluid and best~     corrected visual acuity (BCVA) in choroidal neovascularizations (CNV) due to age-related~     macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment~     interval failed to be extended to 6 weeks intervals in a treat and extend regimen.~      Objectives: The primary objective is to evaluate the mean maximum recurrence-free treatment~     interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid (for~     explanation see section Objectives). The individual maximum recurrence-free treatment~     interval (in weeks) at 24 weeks is defined as the maximum extension interval which is~     reached during the study follow-up period without showing any CNV activity (any intra-or~     subretinal fluid at OCT or new retinal hemorrhage). This measure reflects the duration of~     aflibercept effect in these lesions with limited response to ranibizumab. Key secondary~     Outcome Measures are mean changes in BCVA score at 24 weeks from baseline (Δ BCVAscore),~     mean changes in CRT (µm) at 24 weeks from baseline (Δ CRT), mean number of treatments needed~     during the 24 weeks study follow-up, number of participants with adverse events and serious~     adverse events (for further outcome measures see section Objectives).~      Population: This outpatient study population will consist of a representative group of 33~     male and female patients ≥ 50 years of age. The study population will include patients with~     subfoveal CNV secondary to AMD and being pre-treated with intravitreal ranibizumab in a~     treat and extend regimen and failed to be extended to 6-weeks intervals without showing CNV~     activity (for further information see section Criteria).~      Interventions: 1-arm interventional study with 2mg aflibercept intravitreally up to~     4-weekly. The first treatment interval with aflibercept will be 4 weeks and corresponding to~     the treat and extend regime intervals will be increased in 2-weeks-steps as long as no CNV~     activity (any intra-or subretinal fluid at OCT or new retinal hemorrhage) occurs. In case of~     occuring CNV activity the interval is shortened by 4 weeks with a minimum treatment interval~     of 4 weeks.~   "
57134|NCT02309268|"~     The purpose of this research is to monitor how well patients do after surgery for treatment~     of left atrial appendage (LAA).~   "
57135|NCT02309255|"~     The NOR-COR study is a cross-sectional, observational study designed to explore a large~     number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors~     (including anxiety, depression, quality of life) in 1369 patients with established coronary~     heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen~     (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and~     laboratory data, and sputum/saliva for genetic analyses will be collected.~      The main overall aim of the NOR-COR study is to develop new strategies to improve secondary~     prevention for underserved high risk patient-groups with CHD. The first study phase aims to~     collect information necessary to develop empirically based future secondary coronary~     prevention interventions. In a genetic sub-project markers associated with CHD and~     personality type will be explored.~      The study will evaluate current secondary preventive programs and explore the mechanisms~     that link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The~     study will in short term provide new knowledge potentially useful for increasing~     participation in current cardiac rehabilitation/secondary preventive programs. For a longer~     perspective these associations may be useful for design of new intervention programs to~     selected high risk patient groups whom may be in need of programs with different content~     and/or of longer duration than those currently being applied.~   "
57136|NCT02309242|"~     The aim of the proposed project is to study the long-term impact of adjuvant systemic multi-~     agent chemotherapy (cisplatin, anthracyclines, vincristine, methotrexate, alkylating agents)~     in survivors (treated between 1992 and 2014 in UZ Leuven) of paediatric bone or soft tissue~     sarcomas on neurocognitive functioning.~   "
57137|NCT02309229|"~     To use the sputum colour chart as a predictor for cystic fibrosis exaerbations~   "
57138|NCT02309216|"~     The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI~     for suspected child abuse~      Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the~     routine care of the hospitalized infant with comparison to routine radiographic skeletal~     survey images~      Procedures to be used: whole-body MRI images~      Risks and potential benefits: no additional risk (the infant will be receiving and MRI of~     their brain as part of routine care, the additional images will be obtained at the same time~     without additional sedation); benefits to the infant include the identification of injuries~     which would have otherwise been missed by routine care importance of knowledge that may~     reasonably be expected to result: results from this study will potentially influence the use~     of radiographic skeletal survey and decrease the radiation exposure to infants being~     evaluated for suspected child abuse.~   "
57139|NCT02309203|"~     The study objective is to evaluate the safety and effectiveness of the MicroVention FRED~     System when used in the treatment of wide-necked intracranial aneurysms.~   "
57140|NCT02309190|"~     The study consists in determine the transpulmonary pressure in morbidly obesity patients~     that require mechanical ventilation.~        -  both gender~        -  only adults~        -  Medical intensive care patients.~   "
57141|NCT02309177|"~     The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens~     administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small~     Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).~   "
57143|NCT02309151|"~     The overall aim of this prospective, randomized pilot study is to investigate whether acute~     coronary angiography (within 120 minutes) with a predefined strategy for revascularization,~     is safe to implement in patients with out of hospital cardiac arrest. The primary question~     at issue is whether early angiography (within 120 minutes) with a predefined strategy for~     revascularization with percutaneous coronary intervention (PCI) is safe to carry out in this~     group of patients. The patients randomized to acute coronary angiography will be compared~     with a control group who will be treated according to standard practice with coronary~     angiography with possible subsequent intervention according to the current routine, which~     usually does not occur within the first three days after cardiac arrest.~   "
57144|NCT02309138|"~     This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to~     compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes.~     Maternal metabolic profiles and infant growth will be assessed at randomization and at one~     year postpartum.~   "
57145|NCT02309125|"~     The aim of this split mouth study is to compare which method is better in reducing bone loss~     and healing times following implants. Specifically, the two methods investigated will be~     immediate gradual loading and early loading protocol.~      Research Hypothesis Immediate gradual loading using gingival formers is superior to early~     loading protocols in improving bone quality and thus reducing the healing time.~   "
57146|NCT02309112|"~     A feasibility study to determine the appropriateness of yoga intervention to improve~     health-related quality of life in adult cancer patients.~   "
57147|NCT02309099|"~     The goal of this project is to determine whether subjects who have undergone labyrinthectomy~     or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or~     Meniere's disease benefit from cochlear implantation on speech perception and localization~     tasks.~      If the auditory nerve is able to transmit this signal effectively, then these two~     populations may be able to utilize the combination of electric (in the affected ear) and~     acoustic (in the non-affected ear) information for improved speech perception in noise and~     localization as reportedly experienced in other unilateral sensorineural hearing loss~     populations.~   "
57148|NCT02309086|"~     Dendritic cells (DC) play a central role in the activation of T-cell responses and have~     shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this~     study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype~     1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3~   "
57149|NCT02309073|"~     Background: Despite considerable progress in the field of assisted reproductive technology~     (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial~     differences in pregnancy rates are seen between women starting ART from seemingly similar~     clinical starting points and information on pregnancy/neonatal complications after ART is~     limited. For physicians and patients it would be extremely valuable if tools could be~     developed through which individualised chances of live birth and the development of~     pregnancy/neonatal complications can be calculated. In addition, there is increasing~     knowledge about health risks associated with subfertility and in particular with polycystic~     ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research~     to date is the absence of a control group to check important new findings.~      Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular~     indication for ART which can aid the investigators principle lines of research:~        1. To study initial predictors of ovarian response to stimulation for IVF~        2. To study predictors of chances for live birth after repeated IVF cycles~        3. To assess the role for vascular health in the probabilities of success in ART treatment~        4. To study predictors for pregnancy and neonatal complications~        5. To form a control group for cycle disturbance studies~      Study design: In this part of the protocol, serum and material for DNA analysis will be~     collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal.~     This blood will be stored in the Biobank of the UMC Utrecht at -80 C.~      Study population: All women starting ART will be asked to participate.~      Nature and extent of the burden and benefits associated with participation: There are no~     benefits or risks for the study patient as blood is withdrawn during a routine venapuncture~     and results will not be used for clinical practice.~   "
57150|NCT02309060|"~     The overall aim of this program of research is to develop a collaborative narrative~     intervention for patients with depression being treated in primary care.~      The purpose of the proposed project is to establish the feasibility, acceptability, and~     preliminary effects of our newly developed narrative intervention on depression.~      To achieve the specific aims, the investigators will conduct an open trial to further~     develop and refine the intervention (n = 10).~   "
57151|NCT02309047|"~     Through the COLA Study and Biobank the investigators hope to enable further identification~     of phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual~     cycle disturbances; and: the identification of genetic or other etiologic factors associated~     with cycle disturbances.~   "
57152|NCT02309034|"~     Objective: To compare the results of two types of low-impact exercise training, in and out~     of the water, with the control group, regarding cardiometabolic risk factors in overweight~     adolescents; and to investigate the changes resulting from interventions in biochemical,~     anthropometric, psychological variables and body composition.~      Experimental design: Randomized clinical trial with overweight and obesity adolescents.~      Local Search: College of Physical Education of Federal University of Rio Grande do Sul and~     Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil.~      Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and~     post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre~     city.~      Intervention: Adolescents that acepted to participate in the study, and authorized by their~     parents, were randomized into three groups: Group Land / Jump, with three weekly sessions~     Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control~     group that not participate in physical exercise intervention. The intervention will last 12~     weeks and three groups participate in weekly sessions of nutritional guidance. Assessments~     occur at the beginning of the intervention program and 72 hours after the 12th week of the~     program. The results of all study variables among the three groups in the two time points,~     and in each group between the two periods, will compared.~      Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to~     applying instruments for assessing quality of life, body image and mental health by~     experienced evaluators, as well as blood draws conducted by an experienced gatherer's~     Hospital de Clínicas de Porto Alegre.~      Expected Results: In the study, are been expected to verify that the exercise programs,~     aquatic and land, associated with nutritional guidance, are efficient to modify positively~     the outcomes studied.~   "
57153|NCT02309021|"~     The aim is to examine the effect of exercise (EX) training on individuals currently~     receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) -~     for their opiate dependence. Main outcome variables will be: cardiovascular fitness;~     consumption of substances (e.g. street heroin, cocaine, cannabis, alcohol, cigarettes)~     other than prescribed ST or other prescribed medications; substance craving; blood pressure;~     lung function; resting pulse; social interaction; self-control capacity; objective and~     subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood.~     Covariates are current substitution dose and psychiatric diagnoses.~   "
57154|NCT02309008|"~     The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of~     PAC-14028 cream after transdermal administration in healthy male volunteers.~   "
57156|NCT02308982|"~     This is a phase III multi-centre randomised, double blind, placebo controlled trial to~     assess the role of intravenous immunoglobulin in the treatment of children with~     encephalitis. The primary objective is to find out whether early use of IVIG treatment~     improves neurological outcomes of children with encephalitis.~      308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals~     in the United Kingdom. Participants will be randomised to receive two doses of IVIG or~     matching placebo in addition to other standard treatments, within the first five days of~     hospital admission.~      Each participant will be followed up for 12 months. During this period, information on~     clinical, radiological and laboratory investigations will be collected. Neurological~     outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a~     neuropsychological assessment at 12 months.~   "
57157|NCT02308969|"~     The aim of the present study is to assess the neuronal correlates of alterations in waking~     consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in~     healthy subjects using functional magnetic resonance imaging (fMRI).~   "
57158|NCT02308956|"~     Task sharing mental health care through integration of mental health into primary health~     care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in~     low-income countries. In Ethiopia, it is estimated that only around 10% of people with~     severe mental disorders (SMDs) ever receive evidence-based treatment for their condition,~     largely due to scarcity of specialist mental health services. A task-sharing model of mental~     health care in PHC would be more affordable and accessible to the majority of persons with~     SMD who do not currently receive evidence-based mental health care. Furthermore, task~     sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the~     National Mental Health Strategy. However, the effectiveness of the task sharing model of~     mental health care for people with SMD has not been evaluated systematically in a low-income~     country. In this study we propose to investigate non-inferiority of a task sharing model of~     mental health care in PHC compared to a less accessible, but more specialist, psychiatric~     nurse-led model of care. The specialist model of care has been demonstrated to be acceptable~     and associated with improved clinical outcomes for persons with SMD engaged in the service~     in Ethiopia thus making this an appropriate comparison model against which to evaluate~     non-inferiority of the task sharing model.~   "
57159|NCT02308930|"~     The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg)~     will improve the cognitive performance, associated metabolism and growth in normal children~     aged 6-12 years in primary schools.~   "
57160|NCT02308917|"~     The initial network clinical study will be an inception cohort study in children with new~     onset IBD (Inflammatory Bowel Disease) rigorously phenotyped and prospectively followed.~     Focusing on a prospective, inception cohort of Canadian children of widely varied racial~     origins provides a unique opportunity to explore environmental risk factors early in life~     and close in time to disease onset, their influence on the host microbiome, and in the~     context of genetic susceptibility. In keeping with current treatment targets, assessed~     outcomes will include not only symptom resolution and growth, but also intestinal healing.~     Anticipated variation between network sites in choices of evidence-based therapies, even~     among phenotypically similar sub-types of Crohn disease and ulcerative colitis, will allow~     comparisons outcomes with disparate treatments, aiming to identify best practice and to~     institute processes for continual improvement in care nationally.~   "
57161|NCT02308904|"~     The improved long-term survival of thalassemia major (TM) patients has resulted in increased~     focus on the ability to preserve fertility. While the association of iron toxicity with~     vital organ dysfunction, heart and liver, has been extensively investigated, the correlation~     of reproductive capacity and extent of iron overload is not well understood. Despite~     remarkable progress in methodology for prediction of reproductive status and intervention~     for preserving fertility, implementation in thalassemia is lacking.~      The investigators hypothesize that iron toxicity to the anterior pituitary occurring in the~     process of transfusional iron loading is directly associated with a decline in gonadal~     function. The investigators expect pituitary MRI measurements of iron deposition as well as~     markers of oxidative damage to correlate with the functional studies of pituitary-gonadal~     axis performed in this study. This cross sectional study will examine the relation of~     pituitary iron deposition and pituitary volume; serum iron and oxidative stress measures,~     liver iron concentration (LIC), cardiac iron and chelation adequacy with pituitary and~     gonadal reproductive hormone levels (and spermatogenesis in adult male patients), in order~     to better define the association of iron burden and chelation patterns with fertility~     potential, in thalassemia patients with iron overload. The study will assess whether the~     current chelation treatment regimens, in particular during the pubertal developmental age,~     are adequate for preserving fertility and could lead to improved chelation routines for~     preventing the high prevalence of compromised fertility. In addition, by utilizing~     state-of-the-art markers for fertility status, findings from this study may improve current~     methods for screening for hypogonadism and reproductive potential and allow earlier~     intervention.~      The investigators propose to examine 26-30 patients, 12 years and older, with measures of~     fertility potential, and correlate them to their current iron burden parameters and to the~     cumulative iron effect as indicated by past iron overload patterns and chelation history.~   "
57162|NCT02308891|"~     Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and~     serious complication of ERCP procedures, occurring in approximately 5-15% of unselected~     patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several~     investigations in recent years. Hydration is considered a mainstay of treatment for acute~     pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether~     intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP~     pancreatitis.~      Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo~     diagnostic or therapeutic ERCP will be recruited.~      Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration~     (treatment arm) or standard hydration (standard arm). Randomization will be performed in a~     double blinded fashion using computer-generated random numbers.~      Treatment arm (vigorous hydration arm);~        -  Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP~        -  Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and~          continued for 8 hours.~        -  At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over~          1hour Standard arm (standard hydration arm);~        -  Patients will receive lactated Ringer's solution at the start of the ERCP and the~          fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for~          8hours after ERCP.~      The primary endpoint was development of post-ERCP pancreatitis, which define as increased~     pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three~     times the upper limit of normal).~      The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of~     pancreatitis, and fluid overload.~   "
57163|NCT02308878|"~     Heroin use has been related to brain dysfunction particularly in the prefrontal cortex.~     These effects are evident in neuropsychological impairments in attention, memory and~     executive functioning of heroin users. To assess these deficits and the application of a~     novel approach of cognitive stimulation to heroin users in treatment for opioid dependence,~     we have carried out a neuropsychological intervention program with mobile health technology.~     Patients diagnosed with opioid dependence were submitted to cognitive stimulation during~     four weeks in a three-day/week basis.~   "
57164|NCT02308865|"~     Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing~     early Palliative care versus Standard care in patients with non-small-cell metastatic lung~     cancer~   "
57165|NCT02308852|"~     Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic~     stroke patients to improve bimanual activities and motor learning.~      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying~     bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.~      A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used~     for motor learning.~   "
57166|NCT02308839|"~     This is a French Registry mandated by the French National Health Authority assessing~     long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of~     infra-renal Abdominal Aortic Aneurysms (AAA).~   "
57167|NCT02308826|"~     This project is intended to provide a rigorous test of the Turtle Program, an early~     intervention program for behaviorally inhibited preschoolers. The proposed project will~     extend promising pilot study findings by: (a) evaluating the integrated intervention in a~     larger sample (n = 150) of 45-64 month children and their parents, which will allow for an~     examination of mediators and moderators of treatment effects; (b) comparing the Turtle~     Program to the best available treatment for preschool behavioral inhibition, the Cool Little~     Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation~     as both baseline moderators of treatment response and as outcome measures; (d) examining~     parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment~     assessment and extending follow-up to one year.~   "
57168|NCT02308813|"~     Several studies exist on patient performance in drive simulators especially around and after~     surgery. Recommendations concerning the ability to drive preoperatively are based on these~     studies, which generated their data using drive simulators. However, in all the datasets~     driving performance remains highly individual. Since a drive simulator is not readily~     available in normal general practitioner surgeries it would be helpful to have convenient~     clinical tests to evaluate a patients individual ability to perform an emergency stop. This~     study aims at evaluating different possibilities how such performance might be predicted.~     Patients with hip osteoarthritis and patients who have received total hip arthroplasty are~     tested clinically and their results are compared with the gold standard experiment - a drive~     simulator.~   "
57169|NCT02308800|"~     The investigators plan a randomized clinical trial of 150 patients with infected~     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness~     of negative pressure wound therapy with continuous irrigation and negative pressure wound~     therapy without irrigation.~      The investigators will enroll 150 patients from two centers: The University of Texas~     Southwestern University Hospital and Parkland Hospital. The investigators will screen and~     enroll patients with wounds in the inpatient setting. Patients will randomized to receive~     traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average~     hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their~     wound surgically closed during hospitalization will be discharged with negative pressure~     wound therapy without irrigation for up to a total of four weeks of therapy. After discharge~     from the hospital, subjects will be seen twice weekly by home health, and the investigators~     will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or~     until the wound heals.~   "
57170|NCT02308787|"~     Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia®~     Apheresis System for Platelet Depletion Procedures.~   "
57171|NCT02308774|"~     We plan a cohort study of 40 diabetic patients admitted to Parkland hospital with a foot~     infection. We will enroll a representative cross section of subjects with diabetic foot~     infection. Patient will be consented and will receive therapy based on standard protocols.~     Currently patients with suspected osteomyelitis have bone biopsies to identify bacterial~     pathogens and verify MRI diagnosis. Repeat bone biopsies are performed at the end of therapy~     to verify that osteomyelitis has been successfully treated. Serum to measure procalcitonin~     will be obtained at baseline, week 3 and week 6.~   "
57172|NCT02308761|"~     TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain~     inhibitor. This study is designed to characterize the safety, tolerability, and~     pharmacokinetics of TEN-010 in patients with relapsed/refractory acute myeloid leukemia~     (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). In~     addition, this trial will assess response to treatment using International Working Group~     (IWG) response criteria. This study will be conducted in two parts: dose escalation and dose~     expansion. For dose escalation (Part A), a standard 3+3 design will be used in which~     successive cohorts of three or more patients with RR-AML or HMA-refractory MDS will be~     treated at escalating doses until a maximum tolerated dose (MTD) is identiﬁed. For the dose~     expansion part of the study (Part B), patients will be treated with TEN-010 at the MTD (or~     the highest dose tested if the MTD is not deﬁned) to further characterize its safety,~     pharmacokinetics, and clinical response. A maximum of 68 patients aged 18 years or older~     with RR-AML or HMA-refractory MDS will be enrolled in the study. In part A, up to 18 adult~     patients will be enrolled. This includes up to 18 RR-AML or HMA-refractory MDS patients~     enrolled in 3 dose levels of up to 6 patients each. In part B, up to 50 patients with RR-AML~     and HMA-refractory MDS will be enrolled in separate study groups of up to 25 patients each.~   "
57173|NCT02308748|"~     The primary objective of this research study is to test the hypothesis that late sodium~     current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium~     channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early~     repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel~     block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).~   "
57185|NCT02308592|"~     The purpose of this pilot study is to examine the feasibility of conducting a multi-site~     randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient~     Decision Aid (PDA) for antidepressant use in pregnancy.~   "
57186|NCT02308579|"~     This a retrospective, blinded trial in which collaborators in Italy will review the doppler~     findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an~     attempt to measure reproducibility.~   "
57523|NCT02304185|"~     The purpose of this study is to assess the safety and tolerability of 2 different dose~     levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen,~     intramuscularly (injection of a substance into a muscle), with and without aluminum~     phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.~   "
57174|NCT02308735|"~     Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States.~     Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is~     also increasing, mainly due to an increase in the diagnosis of non-insulin dependent~     diabetes mellitus. A recent study demonstrated that 1.3% of pregnancies are now complicated~     by PGDM and that PGDM now comprises 21% of the diabetes that complicate gestations, which~     represents a two fold increase since 1999. One notable side effect of diabetes is an~     elevation of endogenous ethanol production, which in turn may result in a rise in fetal~     production of fatty acid ethyl ester (FAEE). FAEE found in meconium have been utilized as a~     marker of prenatal ethanol exposure. Therefore, FAEE elevation could call into question~     maternal claims of abstinence from alcohol during pregnancy. This study seeks to determine~     if meconium FAEE levels in the newborns of abstinent women with various classifications of~     diabetes mellitus are increased when compared to non-diabetic, abstaining controls.~   "
57175|NCT02308722|"~     In this study the investigators are testing if the addition of Stereotactic Body Radiation~     therapy (SBRT) prior to surgery improves surgical outcome in patients with borderline~     resectable pancreatic cancer (BRPC).~   "
57176|NCT02308709|"~     The primary objective of this study is to assess the safety and feasibility of personalized~     radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation~     imaging, which selectively avoids irradiating highly-functional lung regions.~   "
57177|NCT02308696|"~     The investigators' overall objective is to evaluate the effectiveness of peer-to-peer~     support programs in preventing the necessity of acute health care and nursing home services~     for older adult populations and in promoting their health and wellness. The investigators'~     Specific Aims are:~        1. To compare the effectiveness of peer-to-peer community support in preventing~          hospitalization, emergency department (ED) use, and nursing home placement in an~          at-risk older adult population relative to standard community services.~        2. To compare the effect of peer-to-peer community support on intermediary measures of~          health and wellness such as self-rated health, depression, and anxiety relative to~          standard community services.~   "
57178|NCT02308683|"~     Current evidence supports a central role of inflammation in the pathogenesis of~     atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory~     atherothrombotic condition associated with high prevalence of thrombotic cardiovascular~     disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels~     of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is~     considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its~     predictive role in determining cardiovascular risk, there is some evidence that CRP may~     represent an active participant in atherogenesis [54]. CRP is expressed in human~     atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to~     represent a significant source of CRP in the inflammatory vessel wall [54].~      Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance,~     impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.~      Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and~     hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a~     natural product, there are an alarming number of purveyors of healthful food who are now~     promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to~     be justified, it is critical to separate scientific evidence from anecdote.~      Herein, the investigators will investigate the effects of Moringa oleifera leaves~     supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and~     clinical outocome in diabetic patients through a cohort study.~   "
57179|NCT02308670|"~     The primary aim of this study is to observe any changes in MRI in MS patients who have~     switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.~   "
57180|NCT02308657|"~     The purpose of the study is to determine the best ways to assess how people are affected by~     myotonic dystrophy type 1 (DM1). The study will assess walking speed, muscle strength,~     muscle size, myotonia, heart rhythm, mental efficiency, and overall health. Participants~     will complete questionnaires to record their ideas about how they are affected by DM1. The~     study will evaluate people with DM1 over 1 year to determine how the condition changes over~     time. The study will identify biomarkers of DM1. Biomarkers are laboratory measurements that~     show the effects of DM1 on a person's muscle tissue or blood. Biomarkers are needed in~     future studies to determine how DM1 may respond to treatments.~   "
57181|NCT02308644|"~     To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal~     bevacizumab injections associated with standard metabolic control in eyes with diabetic~     macular edema (DME) associated with standard metabolic control.~   "
57182|NCT02308631|"~     Indications for colostomy are rectal or anal cancer, diverticular disease, radiation~     enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and~     functional disorders. It is frequently required in critically ill patients who may not be~     able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for~     colostomy without laparotomy, but require general anesthesia.~      Additionally, percutaneous anterior colopexy under colonocopic control offers the~     possibility for improved and faster fixation of the anterior colonic wall to the anterior~     abdominal wall.~      The objective of this study is to evaluate the feasibility of performing fecal diversion~     with the help of a colonoscope and colopexy, without the additional morbidity of abdominal~     exploration.~   "
57183|NCT02308618|"~     The purpose of this study is to evaluate the effects of early mobilization versus~     traditional immobilization rehabilitation programs after surgical Achilles tendon repair on~     the mechanical (torque-angle and torque-velocity relationships) and electrical~     (neuromuscular activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius~     medialis morphology (muscle architecture), functional performance, and the mechanical and~     material properties (force-elongation and stress-strain relationships) of the injured and~     uninjured Achilles tendon.~      The hypothesis is that the early mobilization could reduce the deleterious effects of the~     joint immobilization and improve the tendon healing.~   "
57184|NCT02308605|"~     The hypothesis is that a stroke causes release of purines from brain into blood and that~     this is a very early biomarker of brain ischaemia. The investigators propose a simple blood~     test of substances (the purines) that result from cellular metabolism and are produced in~     excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).~   "
57187|NCT02308566|"~     In this study, the investigators aim to compare cerebral embolic load in patients undergoing~     surgical aortic valve replacement using either the minimized extracorporeal circulation or~     the conventional extracorporeal circulation technique. The detection of cerebral emboli is~     performed not-invasively by transcranial Doppler detection of high-intensity transient~     signals representing solid or gaseous microembolism in the middle cerebral arteries. The~     investigators hope to get more insight in the mechanism (incl. quantity) of cerebral~     embolism during aortic valve surgery using extracorporeal circulation.~   "
57188|NCT02308553|"~     This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial~     designed to characterize the safety and estimate the efficacy of nintedanib when combined~     with paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with~     BRAF wild type metastatic melanoma not previously treated with taxanes or kinase inhibitors.~   "
57189|NCT02308540|"~     Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age~     De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a~     single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young~     adults and PCV-primed toddlers through 4 weeks post vaccination.~      Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject~     will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during~     the screening visit for safety and potential immunological assessments, and 28 days after~     completion of the vaccination schedule for immunological assessments. For adults, the~     vaccine will be given IM into the mid-deltoid muscle of nondominant arm using a 24-gauge~     needle. For toddlers and infants, the vaccine will be given IM into the anterolateral aspect~     of the left thigh. Blood will be collected from adults and toddlers for safety labs at the~     Day 7 post-vaccination visit.~   "
57190|NCT02308527|"~     The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal~     antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or~     Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory~     neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to~     Temozolomide increases the activity of chemotherapy.The primary objective of the study is~     the best response (Complete Response or Partial Response) while trial treatment, within 18~     or 24 weeks depending on the arm of the trial the participant is randomised to. Secondary~     endpoints are assessing the side effects, the length of time before progression (Progression~     Free Survival) and overall survival (OS).~      This trial will address two important questions:~        -  does targeting blood vessel development using bevacizumab, (a monoclonal antibody~          against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour~          when used with existing chemotherapy, compared to the effect of the existing~          chemotherapy alone (temozolomide)?~        -  does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the~          effect on a tumour compared to the effect of one alone (temozolomide) Patients aged~          1-21 years of age with relapsed or refractory high-risk neuroblastoma are randomised to~          one of six treatment arms: Temozolomide (T), irinotecan-temozolomide (IT),~          bevacizumab-T (BT), BIT (bevacizumab-IT), temozolomide-topotecan (TTo) or~          bevacizumab-temozolomide-topotecan (BTTo).~   "
57191|NCT02308514|"~     In this study the investigators want to measure the impact or effects of adding~     cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in~     skin temperature above the injured tissues is presume to have a positive effect in the~     healing process. The combination of conservative care and cryostimulation could then be~     appreciated. The investigators chose to measure these effects with 3 elements: visual analog~     pain scale, validated elbow questionnaire and pain free grip strength. This pilot study~     consist in a two arm design, each arm including 15 patients.~   "
57192|NCT02308501|"~     A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by~     In-Vivo Confocal Microscopy~   "
57193|NCT02308488|"~     Following consent, patients will receive 15 fractions of radiotherapy to the affected breast~     and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging~     obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique:~     one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for~     follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be~     assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after~     completion of radiotherapy. All patients will be followed for toxicity and outcome (local~     and systemic recurrence, survival). In addition, patients will complete a self-assessment of~     QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.~   "
57194|NCT02308475|"~     To assess the ability of a novel 3rd generation dual-source CT system to demonstrate~     myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute~     chest pain.~   "
57195|NCT02308462|"~     In order to identify psychological stress in children and adolescents of mentally ill~     parents as early as possible, a special intervention program (CHIMPs = Children of mentally~     ill parents) was developed. The study at hand will implement this intervention program at~     five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention~     is assumed to reduce children's psychopathology and enhance their health related quality of~     life.~   "
57196|NCT02308449|"~     Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse~     outcome. This human physiology study will examine the extent to which human skeletal muscle~     metabolism and exercise physiology are impaired by iron deficiency.~   "
57197|NCT02308436|"~     In vitro results showed a protective effect against acids for the mouthwash containing~     Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under~     natural oral conditions on the tooth surface and to proof the in vitro results obtained. So~     far there are no effect and safety data of the Curolox™ mouthwash under natural oral~     conditions available.~   "
57198|NCT02308423|"~     in this study the investigators will call patients who had Subchondral fractures and treated~     in our department over the last 20 years.~      The investigators will evaluate their shoulder function by a questionary, Constant score and~     radiologic evaluation.~   "
57199|NCT02308410|"~     A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on~     postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear.~     The purpose of the present study was to compare tourniquet use versus non-tourniquet use~     during total knee arthroplasty for short-term functional recovery.~   "
57200|NCT02308397|"~     The aim of the study is to produce a tolerable alternative to normal wheat bread which would~     be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread~     would be made from wheat so, in contrast to gluten-free bread, would be more comparable to~     standard bread. To make this bread, the investigators will use advanced enzyme technology~     and/or novel formulations to target the digestion or removal of wheat proteins, which might~     be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other~     those that are more useful for baking quality. The investigators will determine palatability~     and tolerance of this new product in a human cross-over, randomised, blind and~     placebo-controlled intervention study.~      It has been estimated 6-10% of the population are sensitive to gluten who do not have~     coeliac disease (CD). Three breads will be produced and tested in this study against a~     suitable reference based on standard wheat flour and baking process~   "
57201|NCT02308384|"~     Background~      Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of~     patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many~     patients present with uncharacteristic or vague symptoms. The faecal marker of human globin,~     iFOBT, could play an important role in aiding the general practitioner in detecting CRC.~      Hypothesis~      It will be possible to implement iFOBT in general practice as a test performed on patients~     who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose~     symptoms could indicate an undiagnosed colorectal cancer.~      Aim~      To implement iFOBT in general practice and evaluate the uptake and clinical use of the test.~     Furthermore, we want to investigate the performance of iFOBT when used on patients~     presenting with uncharacteristic symptoms of CRC, and the clinical implications.~      Materials and methods~      The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18~     municipalities in the central Denmark Region, and these are randomised when to receive a~     continuous medical education (CME). The date of inclusion is defined as the first working~     day in the month the CME is planned to be conducted. The CME is part of an intervention~     aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the~     intervention consist of a start package (iFOBT kits, a guideline and online educational~     material) that is sent to GPs when they are included in the study, and a status mail that~     GPs receive approx. one month after inclusion. The inclusion period is during the first 7~     month of the study period, the study lasts for one year.~      Perspectives~      This study will provide important knowledge on how to improve CRC diagnostics in general~     practice.~   "
57202|NCT02308371|"~     Children who are critically ill often require large amounts of fluid during their acute~     illness. It has been shown in multiple studies that appropriate administration of fluid~     decreases morbidity and mortality, but giving too much fluid can also cause increased~     morbidity and mortality. It is often difficult to discern from physical exam, vital signs~     and labs if the amount of fluid that has been given is appropriate or if a pediatric patient~     requires more fluid. Pulse pressure variation (PPV) is the change in blood pressure when a~     patient is on a ventilator or breathing machine. PPV has been used in multiple adult studies~     to help predict fluid needs in a critically ill patient. In this study, we would like to~     investigate if PPV can help better predict if critically ill pediatric patients in the~     pediatric intensive care unit (PICU) need fluid. The investigators hope that by having the~     additional information that PPV can provide, physicians can more judiciously give fluid and~     thereby improve morbidity of critically ill patients in the PICU.~   "
57203|NCT02308358|"~     The purpose of this study is to evaluate the functional and clinical outcomes of patients~     receiving femoral condyle osteochondral allografts, to evaluate potential predisposing~     factors to failure of such grafts, and to compare the overall outcomes of the grafts to the~     current standard of care for smaller lesions, microfracture. Our hypothesis is that patients~     treated with these allografts will demonstrate significant functional improvement as~     measured by validated outcome scoring measures and their function will be at least equal to~     that of microfracture outcomes.~   "
57204|NCT02308345|"~     Cancer patients about to begin chemotherapy receive large amounts of information regarding~     their prognosis, how chemotherapy improves their prognosis, and the usual side effects of~     the chemotherapy during their first visit to the oncologist. Prior studies have documented~     that less than half of this information is retained after the visit, making it difficult for~     patients to participate in their care and difficult for them to enlist the help of their~     social support. The MiVideo project allows the physician to create a custom 5-minute summary~     video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The~     video will emphasize the major points of the forty-five minute office discussion, allowing~     patients to review the physicians' recommendations and share the information and~     recommendations with others. By providing the patient with this re-cap of their visit, the~     investigators hope to engage them more actively in their cancer treatment. Making the~     information available to friends and family can also help a patient receive both~     intellectual and emotional support during the course of treatment. The primary endpoint of~     this study is improvement of patient care, not research activity.~      Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis,~     stage, chemotherapy treatment plan, and anticipated side effects for patients starting~     chemotherapy for colon cancer will not significantly lengthen the pre-chemotherapy clinic~     visit as compared to visits that do not include video production.~   "
57205|NCT02308332|"~     This study will evaluate the effects of switching Atripla to Eviplera on neurocognition~     measured by neuropsychological testing and functional MRI~   "
57206|NCT02308319|"~     Antiviral therapy for HBV may play an important role here, as a large observation study from~     Taiwan reported that the use of nucleos(t)ide analogues (NUC) was associated with 33%~     reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of~     NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall~     (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active~     liver disease should be treated regardless of their impact on HCC recurrence (patients with~     high serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low~     level HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence.~      In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir~     disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of~     hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency~     ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected~     patients with low viral load.~   "
57207|NCT02308306|"~     The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by~     developing an implementable clinical computerised decision support system based on~     individual patient characteristics.~      The investigators hypothesize that successful pain control with opioids can be predicted~     before treatment initiation with advanced data analyses of data originating from~     pre-treatment EEG, QST and pain-related catastrophic thinking.~      The primary objective of this study is the identification of markers that can be used to~     individualize treatment recommendations, i.e. to reliably predict the response of pain to~     opioids.~      Markers are selected among the most promising data and machine-learning methods are used for~     the prediction. This includes determining the associations between a battery of selected~     pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in~     opioid naïve chronic pain patients, including indication and responder identification.~      The key secondary objectives are as follows: to investigate pre-treatment clinical~     predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of~     the following:~        -  Pain intensity and unpleasantness~        -  Use of rescue analgesics~        -  Physical functioning~        -  Global improvement and satisfaction with treatment~   "
57208|NCT02308293|"~     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people~     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of~     habituation, characterized by suppression of hypoglycemic symptoms, eventually leading to~     hypoglycemia unawareness, which creates a particularly high risk of severe hypoglycemia.~     Recent evidence suggest a pivotal role for (brain) lactate in the pathogenesis of~     hypoglycemia unawareness. Indeed, exogenous lactate administration may preserve brain~     function and attenuate counterregulatory responses to and symptomatic awareness of~     hypoglycemia. It is unknown whether endogenous elevation of plasma lactate produces the same~     effects and whether such effects differ between patients with T1DM with and without~     hypoglycemia unawareness and healthy controls.~      Objective: To investigate the effect of elevated levels of endogenous lactate on brain~     lactate accumulation and on counterregulatory responses to, symptomatic awareness of and~     cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia~     unawareness and normal controls.~      Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through~     high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which~     in turn will attenuate counterregulatory hormone responses, appearance of symptoms and~     deterioration of cognitive function. Second, the investigators posit that these effects will~     be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM~     patients with normal awareness as a consequence of greater transport capacity of lactate~     into the brain.~   "
57209|NCT02308280|"~     Multiple myeloma is a morbid disease associated with a poor outcome, particularly those with~     high-risk cytogenetics. While standard therapies have modestly improved survival in these~     high-risk patients, myeloma remains incurable. To date, the only potential curative~     treatment remains allogeneic hematopoietic stem cell transplantation. However, the high~     incidences of toxicities including chronic GVHD and disease progression are currently the~     two most important obstacles to this therapy. Better approaches to maintain and improve~     benefits of allogeneic transplant, while decreasing toxicity, are urgently needed.~      The investigators hypothesize that Bortezomib administration after non myeloablative~     allogeneic hematopoietic stem cell transplantation in high-risk myeloma patients might~     improved the outcome of these patients by decreasing myeloma relapse and the severity of~     chronic GVHD while preserving the graft-versus-myeloma effect. Our goal is to improve the~     poor clinical outcome of high-risk myeloma patients.~   "
57210|NCT02308267|"~     This project entitled Impaired secretory IgA and mucosal immunity in cystic fibrosis is a~     research program which aims to determine, owing to national (KULeuven) and international~     (Descartes university Paris, university of Torino) collaborations for expertise and access~     to human material, whether a defect exists for the production of IgA antibodies in the lung~     from patients with this serious genetic disease. These antibodies line and protect normally~     the airways, and are secreted through a specific epithelial receptor called pIgR (polymeric~     immunoglobulin receptor); its expression and regulation will be studied in lung tissue and~     in cell cultures of the lung epithelium from these patients. The link between the putative~     IgA defect and chronic bacterial infection with Pseudomonas aeruginosa, which often~     complicates the evolution of the disease, will also be evaluated ex vivo and in vivo, in an~     animal model of lung infection.~   "
57211|NCT02308254|"~     The purpose of this study is to determine the effects of the drug lixisenatide on blood~     sugar levels, stomach emptying, blood pressure and heart rate, release of gut hormones and~     blood flow in the gut after a glucose drink in both healthy subjects and people with type 2~     diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of~     its potential use in the management of the falls in blood pressure following a meal in~     diabetic patients.~   "
57212|NCT02308241|"~     The purpose of this study is to find out the effects, both good and bad, that a drug called~     ribavirin has on the patient and the cancer.~      Ribavirin has also been studied in clinical trials for patients with various types of~     cancer. These studies demonstrated that ribavirin can be safely given at higher doses than~     the dosing that is used as part of the treatment of hepatitis C.~      Ribavirin is known to target a protein called 4E that turns on a central part which causes~     the cell to grow, called the ribosome. HPV-related cancers often have abnormally high levels~     of 4E. The purpose of this study is to evaluate if ribavirin may be a useful treatment for~     patients with advanced cancers that are related to HPV by blocking the activity of 4E.~   "
57213|NCT02308228|"~     The purpose of this study is to determine whether a commonly prescribed drug, metformin, can~     enhance the benefits seen during resistance exercise such as increased muscle mass and~     strength.~   "
57214|NCT02308215|"~     The main purpose is to find a better way to predict the timing of treatments given to~     patients with Wet Age-related macular degeneration using image analysis.~   "
57227|NCT02308046|"~     The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the~     treatment of vaginal infections~   "
57228|NCT02308033|"~     The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the~     treatment of vaginal infections.~   "
57524|NCT02304172|"~     The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat~     device to that with the harmonic scalpel.~   "
57215|NCT02308202|"~     The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d~     combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.~      The effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR)~     exposure therapy will be assessed in double-blind, placebo-controlled study. The study will~     enroll 30 participants. The investigators will use a within groups design in which all~     participants receive both placebo and doxazosin (N=16) with the order counterbalanced across~     participants. A second group of patients (N=16) will receive both 16mg perindopril and~     placebo instead of doxazosin/placebo.~   "
57216|NCT02308189|"~     A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow~     restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and~     endurance, whole body and regional lean mass and bone density, as well as the rate of~     recurrence of LBP (secondary outcomes).~   "
57217|NCT02308176|"~     INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance~     there is always a positive energy balance, with less energy expenditure than that obtained~     from the intake. Low physical activity is often an important factor in this lower spending.~     Medical advice is useful for determining changes in the habits of life of patients, however,~     the changes produced by the council do not last over time, so it would be necessary to~     establish enforcement mechanisms as with mobile technology, because it could improve the~     adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of~     an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to~     lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS:~     Open randomized controlled clinical trial with clinical practice (health advice for physical~     activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged~     between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary~     endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart~     rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of~     physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm).~     Statistical analysis: The primary endpoint (weight reduction) will be evaluated by~     covariance analysis adjusting by baseline weight, and other confounding variables (sex, age,~     level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.~   "
57218|NCT02308163|"~     The objective of this study is to verify the superiority of ASP015K alone or in combination~     with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in~     patients with rheumatoid arthritis (RA) who had an inadequate response to DMARDs~   "
57219|NCT02308150|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     replacement (TAVR) in the Asian Pacific population~   "
57220|NCT02308137|"~     The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily~     can prevent worsening of walking ability in people secondary progressive MS. The number of~     participants in this study will be 62. A maximum of 75 people with secondary progressive MS~     will be included. Each patient will be followed for 12 months from inclusion. Domperidone is~     a medication which has been shown to increase levels of the hormone prolactin. The best~     understood function of prolactin is the stimulation of milk production in women after~     delivery. However, the increase in prolactin levels seen in patients treated with standard~     doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical~     symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore~     may also improve myelin repair in people with MS. Domperidone is currently approved in~     Canada to treat slow moving bowels and nausea, for instance in patients with Parkinson's~     Disease or Diabetes Mellitus, where too slowly moving bowels can cause constipation.~     Domperidone is available as a tablet that is usually taken four times per day. Doses up to~     80mg per day may be used but we estimate that a dose of only 40mg daily will be needed to~     stimulate myelin repair. Domperidone is usually well tolerated.~   "
57221|NCT02308124|"~     Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic~     hypotension and investigate the quality of life of treatment of neurogenic orthostatic~     hypotension.~   "
57222|NCT02308111|"~     Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver~     disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and~     eventual cirrhosis requiring liver transplantation or resulting in death. The~     investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is~     derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action~     of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie~     its hepatoprotective effects and result in attenuation of injury and improved liver function~     in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared~     to placebo, combined with stable standard care, on clinical outcomes in PBC patients.~   "
57223|NCT02308098|"~     The purpose of this study is to confirm equivalent bronchodilator efficacy of the test~     product compared to the reference product.~   "
57224|NCT02308085|"~     The best available evidence suggests that pregnancy after breast cancer does not increase a~     woman's risk of developing a recurrence from her breast cancer. In particular, the most~     recent data suggest that this is the case also in women with a hormone receptor-positive~     breast cancer. There is also no indication of increased risk for delivery complications or~     for the newborn. The aim of the study is to investigate if temporary interruption of~     endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of~     breast cancer recurrence.The study aims also to evaluate different specific indicators~     related to fertility, pregnancy and breast cancer biology in young women. A~     psycho-oncological companion study on fertility concerns, psychological well-being and~     decisional conflicts will be conducted in interested Centers.~   "
57225|NCT02308072|"~     The phase I trial aims to determine the recommended phase II dose (RP2D) and schedule of~     olaparib in combination with standard cisplatin-based chemoradiotherapy, in patients with~     high-risk locally advanced squamous cell carcinoma of the head and neck (HNSCC), by~     assessing the safety and tolerability of the treatment combination.~   "
57226|NCT02308059|"~     The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in~     people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with~     clinical and demographic data.~   "
57232|NCT02307981|"~     Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field~     defects. Visual Field defects are negatively correlated to falling, institutionalisation,~     rehabilitation outcome and quality of life. Patients are often not properly examined and~     seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual~     Field defects after occipital infarction and to determine whether rehabilitation is~     effective.~   "
57233|NCT02307968|"~     To observe the patient's preference, pain perception, and usability between inner and outer~     upper thigh for insulin therapy. To add another injection site for insulin therapy.~   "
57234|NCT02307955|"~     The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot~     to twitch, and has been shown to increase blood flow. The device is also indicated for the~     treatment of oedema. In this study the investigators intend to assess the use of the device~     as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.~   "
57235|NCT02307942|"~     The main objective of this study is to compare the efficacy of two weight losing strategies~     (obesity surgery with gastric banding, and standard of care) on physical performance in~     elderly obese persons submitted to a physical training. Our hypothesis is that a~     surgery-induced weight loss in the context of a physical training (which is recommended in~     people 60-75 yrs losing weight) improves physical performance as compared to standard of~     care (3-5% weight loss).~   "
57236|NCT02307929|"~     In the past two decades, as a result of population aging and shifts in patient needs, we~     have seen an increased demand for chronic disease management (CDM) delivered in the~     community. The Hong Kong Government introduced six nurse allied health clinics (NAHC)~     programme to assist the delivery of care to facilitate the increased demand on chronic~     disease management (CDM) in the community, which are currently being piloted within the~     government funded general outpatient clinics (GOPC) of the Hospital Authority (HA). These~     programmes are designed to enhance CDM in primary care through patient empowerment and use~     of multi-disciplinary nurse and allied health led teams, and aim for secondary prevention~     and treat-to-target for specific health conditions. This model of care has already been~     established in a number of countries, namely United Kingdom, Australia, Canada and United~     States, where multi-disciplinary allied-health clinics, nurse practitioners and nurse-led~     clinics have already been integrated into routine practice in primary care (Thomas, Cullum~     et al. 2000; Laurant, Reeves et al. 2005).~      The six NAHC programmes which have been developed to date address falls prevention (FP),~     continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management~     (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the~     QOC is an essential part of the programme in order to inform future policy. he Department of~     Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been~     appointed by the HA to carry out the evaluation of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the NAHC programme is achieved. Each NAHC participating clinic will be~     invited to complete a structured evaluation questionnaire. Anonymized data of all patients~     who have enrolled into the NAHC programme for more than 6 months will be included in the~     evaluation on the process and outcomes of care. Data on the process of care will be~     retrieved from the HA medical records.~      In-depth study of NAHC CC programme: In order to compare the outcomes over time between~     subjects who have and who have not participated in the NAHC Continence Care Programme, three~     hundred and sixty control patients who have not been enrolled into the NAHC CC programme~     will be selected for the comparison in the outcomes of care. Subjects will be followed up by~     telephone to evaluate the effect of the programme in quality of life (QOL), patient~     enablement, and global rating of change in health condition at baseline , 12-month and~     24-month after enrollment.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the planned process of care and have improvement in clinical outcomes.~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The changes in clinical, service and patient reported outcomes between baseline~     and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4~     times over a period of 5 years.~      In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and~     control group will be compared by independent sample t-test or Chi-square test.~      Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     NAHC programmes enhance the QOC of their participating patients. This information will be~     used to guide service planning and policy decision making.~   "
57237|NCT02307916|"~     A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic~     membrane as the primary measureable outcome. The goal is to determine the safety and~     efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane~     perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in~     humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for~     tympanic membrane perforation. A total of 60 subjects will be recruited.~   "
57238|NCT02307903|"~     Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and~     maintain electrolyte balance, which is lethal unless they are given renal replacement~     therapy (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the~     HA has introduced the haemodialysis public-private partnership (HD PPP) programme to shorten~     the waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new~     service provision model that purchases healthcare services from non-Government healthcare~     organizations. The evaluation on the quality of care (QOC) is an essential part of the~     programme in order to inform future policy. The Department of Family Medicine and Primary~     Care of the University of Hong Kong has been appointed by the HA to carry out the evaluation~     of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the HD PPP programme is achieved. Each HD PPP participating hospitals and~     centers will be invited to complete a structure evaluation questionnaire. Sixty patients who~     have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP~     will be included. The participants will be followed up by telephone to evaluate the effect~     of the programme on quality of life (QOL), patient enablement, and global rating of change~     in health condition. Data on the process of care and clinical outcomes of care will be~     retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months~     by paired sample t-test. The outcomes between HD PPP subjects and control group will be~     compared by independent sample t-test or Chi-square test.~      Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and~     possible areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HD PPP~     can achieve equivalent QOC as the usual HA care in order to guide service planning and~     policy decision making for patients with ESRF.~   "
57239|NCT02307890|"~     Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation~     but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one~     or more bile ducts probably caused by inadequate blood flow or a failure of biliary~     epithelium to regenerate. It typically presents weeks to months after liver transplantation,~     is often refractory to treatment and can result in a requirement for re-transplantation.~     Although IC is more common following DCD liver transplantation, it is otherwise very~     difficult to predict and the underlying pathogenesis is poorly understood. The aim of this~     study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile~     duct biopsies taken during liver transplantation with the incidence of IC following liver~     transplantation.~   "
57240|NCT02307877|"~     Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate~     have not been examined in patients with relapsing forms of multiple sclerosis (MS). As~     patients on long term therapy typically have little or no overt signs of white matter~     inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into~     whether there is continued progression of MS in these patients. What remains unknown is~     whether patients on a particular therapy have a slower rate of brain atrophy. This would~     provide convincing evidence that central nervous system tissue injury is further suppressed.~     Such information would be of substantial clinical benefit when deciding between various~     therapies.~      The investigators will estimate the impact of long term use of fingolimod therapy (defined~     as a minimum of two years on therapy) on whole brain atrophy in treated patients with~     relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate.~      The investigators secondary goal is to determine the correlation between brain atrophy and~     cognitive performance in treated patients with relapsing forms of MS.~      The investigators will also examine the correlation between the NeuroQualityofLife~     (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical~     disability, work productivity, clinical assessments of cognitive functioning with whole~     brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate~     therapy matched on age and gender.~      The investigators anticipate the findings of this study will generate relevant hypotheses~     about these relationships.~   "
57241|NCT02307864|"~     The purpose of this study is to assess the effects of multiple doses of an immediate release~     (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels~     in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart~     rate (QTc).~   "
57242|NCT02307851|"~     The purpose of this study is to determine the immune response of three dose levels of the~     Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four~     treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups~     A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will~     receive a commercially available trivalent influenza vaccine (TIV). The study will also~     evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.~   "
57243|NCT02307838|"~     This study aims to collect follow-up data on approximately 90% of patients who were~     randomized and received one dose of study drug in FTY720D2201. No study drug is given or~     required. Patients will be required to be assessed at one or two visits, preferably at the~     original study site, but the option to be interviewed via phone or seen at home is provided.~     Information will also be gathered on deceased patients. Assessments will be performed only~     once within an 8 week period and include medical history, Multiple Sclerosis (MS) and~     Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status~     Scale (EDSS), Magnetic Resonance Imaging (MRI), Multiple Sclerosis Functional Composite~     (MSFC).~   "
57244|NCT02307825|"~     Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases~     with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients~     do not respond to standard medical and surgical treatment, thus continuously increasing the~     symptomatologic and socio-economic burden of this disease.~      Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the~     treatment regimen of patients with refractory CRS failing conventional medico-surgical~     treatment will be beneficial in a symptomatologic and endoscopic level.~      Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is~     effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to~     standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.~      Secondary objectives:~      i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS~     treatment of ESS and BUDI, with the addition of low-dose AZI.~      ii) Characterise and define the population deemed high-risk for standard CRS treatment~     failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora~     microbiome of patients at the different follow-up points of this study.~      iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the~     nasal flora microbiome associated with successful AZI therapy.~      Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS~     operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all~     patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and~     will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI~     will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months.~     At every follow-up, complete endoscopic exams will be performed, along with sinus cultures~     and brush cytology.~      Population: All patients deemed high-risk with CRS admitted for ESS between October 2014~     and October 2015.~   "
57245|NCT02307812|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the ATU.~   "
57246|NCT02307799|"~     The aim of the RESPECT study is to gain a better understanding of the prevalence,~     pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study~     seeks to address the following specific objectives/research questions: 1) to estimate the~     prevalence of airflow limitation (AL) and COPD in adults 35-70 years of age in St.Petersburg~     and Arkhangelsk based on sex, age, environmental conditions, socioeconomic status and~     smoking status; 2) to compare the prevalence of COPD in the study population based on the~     Global Strategy for Diagnosis, Management and Prevention of COPD (GOLD) and lower limit of~     normal (LLN) criteria; 3) to identify the diagnostic value of various signs, symptoms and~     background characteristics for the diagnosis of COPD; 4) to determine whether differences in~     background characteristics and inflammatory biomarkers are evident between smokers with and~     without COPD; and 5) to describe co-morbidity, functionality and global health status in a~     cohort of newly diagnosed COPD patients.~   "
57247|NCT02307786|"~     Beta thalassemia (β-thalassemia) is the most common genetic disease worldwide. Individuals~     with thalassemia are born with a defect in hemoglobin. Hemoglobin is a protein in red blood~     cells that carries oxygen to vital organs such as the brain, heart, lungs and kidneys.~     Thalassemia major is a hereditary anemia characterized by little or no ß-globin production,~     which results in hemolysis (breakdown or destruction of red blood cells) due to the~     formation of unstable alpha-globin tetramers and ineffective erythropoiesis which is~     uniformly fatal in the absence of regular transfusions. Although improvements in~     conservative treatment have improved the prognosis of thalassemia considerably disease and~     transfusion related complications in affected patients progress over time, causing severe~     morbidity and shortened life expectancy. Substantial lifelong health care expenses are also~     involved, often a financial burden for families and unsustainable in most developing~     countries.~      The hypothesis is that patients who had beta thalassemia who have undergone a hematopoietic~     stem cell transplant (HSCT) and are >1 year post-HSCT will have less long term comorbidities~     and a higher quality of life (QOL) as compared to those with beta thalassemia who are~     maintained on supportive care. In order to assess quality of life, a quality of life~     questionnaire will be asked. Extraction of data from the patient's medical record will also~     be used to determine any comorbidities that have occurred after either a HSCT or supportive~     care therapy.~   "
57248|NCT02307773|"~     The investigators tested whether a new method which additional lidocaine spray on the tip of~     endoscope can increase the tolerance of examinee during endoscopy than conventional~     pharyngeal anesthesia alone.~   "
57249|NCT02307760|"~     The purpose of this study is to assess growth of preterm infants fed human milk supplemented~     with one of two commercially available human milk fortifiers.~   "
57250|NCT02307747|"~     Circadian rhythms, which play crucial roles in physiology, are emerging as important~     regulators of specific immune functions. Hospitalization in intensive care unit leads to a~     deep impairment of circadian rhythm. Infection is a frequent event during ICU~     hospitalization.~      The investigators hypothesis is that in trauma patients the lack of circadian rhythm~     variations is associated with the occurrence of infection. The primary aim of the study is~     to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related~     infection during the 30 days after inclusion. The secondary aims are to assess the plasma~     expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines~     in plasma, and the concentration of cortisol, according to the occurrence of an infection.~   "
57251|NCT02307734|"~     This project proposes two aims. The first aim is to evaluate the efficacy of a~     family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male~     smokers using a 2-arm cluster randomized controlled trial with assessments at baseline, 6,~     and 12 months targeting 360 smoker-family dyads. Half of the participants will be assigned~     to the proposed intervention, and the remaining half will be assigned to an~     attention-control condition where they will receive education on healthy eating and physical~     activity. The second aim is to explore mediators to identify key psychosocial and behavioral~     processes that underlie how the intervention affects the processes of quitting and~     maintaining abstinence in Chinese and Vietnamese smokers.~   "
57536|NCT02304016|"~     The purpose of this study is to determine if patients with third and fourth degree obstetric~     lacerations benefit from a short course of pelvic floor physical therapy in the immediate~     postpartum period.~   "
57252|NCT02307721|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. The annual death toll from overdose is about 250, higher than road traffic~     accidents. Those who inject heroin or other opioids are considered to have the highest risk~     for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as~     naloxone is required. Usually naloxone is injected into a muscle or a blood vessel.~     Administration of naloxone via the nose (intranasal) has been suggested as an alternative~     for use by emergency teams and possibly also bystanders. This is not only an easier way to~     give naloxone, but would also eliminate the risk for needle stick injuries and blood~     contamination. In a series of studies on intranasal naloxone at The Norwegian University of~     Science and Technology, this study explores pharmacokinetics and pharmacodynamics of~     intranasal and intramuscular naloxone in healthy volunteers under the influence of~     remifentanil.~   "
57253|NCT02307708|"~     The purpose of the study is to compare the treatment by wearing shoes inclined at~     kinesitherapy because it is the first treatment offered by primary care physicians in~     chronic Achilles tendinopathy.~   "
57254|NCT02307695|"~     To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the~     glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon~     secretion, improving beta cell function, and re-regulating of the T cell immune system.~   "
57255|NCT02307682|"~     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)~     injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects~     with untreated active choroidal neovascularization (CNV) secondary to age-related macular~     degeneration (AMD) in the study eye.This study will be conducted in Argentina, Australia,~     Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Israel, Japan, Mexico, Panama, Peru,~     New Zealand, and US (including Puerto Rico).~   "
57256|NCT02307669|"~     The investigators hypothesize that aligning adherence with the patient's own clinical course~     achieves better asthma control and identifies risks for future loss of control, compared to~     current best practice. The study has an adherence optimisation phase, week 1-12 followed by~     a medication management phase, week 12 to week 32.~      The investigators will compare two asthma education interventions, standard Guideline~     recommended practice and feedback from the individual's own INCA device, which assess~     inhaler adherence and relates adherence with changes in PEFR and symptom scores over time.~      The aim of the study is to then incorporate adherence into Guideline recommended medication~     changes so that asthma control is improved and medication rationalised at the end of the~     intervention.~      A secondary aim is to assess the long-term effectiveness of this approach on control and~     exacerbations.~   "
57257|NCT02307656|"~     The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat~     (COBI) alone and in combination as well as oral test formulations containing both ATV and~     COBI.~   "
57258|NCT02307643|"~     The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy~     of MT-1303 in subjects with systemic lupus erythematosus~   "
57259|NCT02307630|"~     The purpose of this study is to find out how an antibody called Hu3F8 travels through the~     body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight~     infections. Antibodies can be made by your own body or in a laboratory. The target of an~     antibody is called an antigen; antibodies fit their antigen like a lock fits a key.~   "
57260|NCT02307617|"~     The purpose of this study is to learn if measures of brain chemicals from a brain scan~     called Magnetic Resonance Imaging and Spectroscopy (MRI/MRS) and brain activity (known as~     cortical excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS)~     are different in adolescents with depression who are in different stages of treatment.~      Researchers are conducting this study to learn more about how the brain works in adolescents~     with depression and without depression (healthy controls). This is important because it may~     identify a biological marker (a measure of how bad an illness is) for depression that could~     one day be used to identify depressed adolescents who would benefit from certain treatments~     (medications for example) or to monitor how well treatments are working.~   "
57261|NCT02307604|"~     The SPECTAbrain protocol describes a structure for screening patients with brain tumors to~     efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical~     trials. Efficiency is promoted through the creation of a clinical database of brain tumor~     patients and the respective human biological material biobank for molecular~     characterization. The main objectives are to:~        -  Allocate patients to clinical trials according to the clinical characteristics and~          molecular profile of their tumor;~        -  Identify or validate new molecularly defined subgroups of tumors;~        -  Investigate the prevalence of novel biomarkers to plan future clinical trials;~        -  Enable exploratory/future research;~        -  Facilitate establishment of quality-assured and validated tests for Central Nervous~          System (CNS) tumor biomarkers;~   "
57262|NCT02307591|"~     The purpose of this study is to evaluate the efficacy and safety of amiodarone in the~     treatment of patients afflicted with Ebola virus disease.~   "
57263|NCT02307578|"~     The main objective of the Extended Access Program (EAP) is to ensure that subjects~     participating in Study E2007-G000-332 continue to have access to perampanel until the time~     perampanel becomes commercially available in the country in which they reside.~   "
57264|NCT02307565|"~     Following spinal cord injury autonomic regulation of the cardiovascular system is impaired,~     which results in a variety of measurable abnormalities in blood pressure. Evidence of~     causality has been documented in the general medical literature with findings of improved~     cognitive function following acute increases in blood pressure using the anti-hypotensive~     agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an~     inverse association between blood pressure and depression suggesting that low blood pressure~     may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food~     and Drug Administration to treat low blood pressure in the general population. Midodrine is~     not approved in the United States to treat low blood pressure in persons with spinal cord~     injury. Therefore, its use in this study is investigational. The first objective is to~     characterize the relationship between blood pressure, cerebral blood flow velocity and~     cognitive function after a single dose of midodrine compared to placebo. Second objective is~     to determine the long-term safety and efficacy of midodrine administration.~   "
57265|NCT02307552|"~     This study is being performed to verify the ability to use minimally invasive transurethral~     ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral~     ultrasonic prostate imaging, may in the future, be used for detection and monitoring these~     disease processes to minimize the need for obtaining surgical biopsy specimens. The~     hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging,~     results in unique image signatures for identification of prostate cancer. This imaging~     procedure provides a multifaceted view of the entire in-situ gland.~      The current use of Prostate Specific Antigen (PSA) for determining the likelihood of~     presence of cancer in the prostate gland requires interpretation and has a good but limited~     to predict prostate cancer on biopsy, with significant false prediction rates. More~     importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the~     cancer within the prostate gland. Preliminary study findings have suggested that~     Transurethral Ultrasonic Scanning (TUUS) presents the desired improved diagnostic~     sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic~     capability to provide high resolution images of the transverse and future three-dimensional~     views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two~     important goals of the practicality of this minimally invasive technology will be assessed~     by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the~     prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci~     with a high rate accuracy.~   "
57266|NCT02307539|"~     This pilot clinical trial studies a palliative care program in improving the quality of life~     of patients with newly diagnosed pancreatic cancer. Palliative care is care given to~     patients who have a serious or life-threatening disease, and focuses on managing disease~     symptoms, side effects of treatment or the disease, and improving patient quality of life.~     Studying a palliative care program used for other types of cancer may help doctors learn~     whether it can improve the quality of life of patients with pancreatic cancer.~   "
57267|NCT02307526|"~     Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI)~     experience blood pressure (BP) dysregulation which manifests in chronic hypotension with~     exacerbation during orthostatic positioning. Although many individuals with SCI remain~     asymptomatic to hypotension and orthostatic hypotension (OH), we recently reported reduced~     memory and marginally reduced attention and processing speed in hypotensive individuals with~     SCI compared to a normotensive cohort. Thus, we believe that treatment of overtly~     asymptomatic hypotension and OH in the SCI population is clinically warranted. Currently the~     FDA has approved only midodrine hydrochloride for the treatment of dizziness associated with~     OH and proof of efficacy is limited. Acetylcholinesterase inhibition for treatment of OH is~     a novel concept and has gained recent recognition in models of neurogenic OH (multiple~     system atrophy; pure autonomic failure, diabetic neuropathy). The physiological rationale of~     this concept is unique: acetylcholine (AcH) is the pre-ganglionic neurotransmitter of the~     sympathetic nervous system. Inhibition of acetylcholinesterase will limit the breakdown of~     AcH thereby facilitating vascular adrenergic tone and peripheral vasoconstriction.~     Acetylcholinesterase inhibition has been reported to be efficacious in models of both~     pre-ganglionic (multiple system atrophy) and post-ganglionic (pure autonomic failure,~     diabetic neuropathy) origin and persons with SCI reflect a model of a preganglionic~     disorder. In theory, if an individual has a complete autonomic lesion, acetylcholinesterase~     inhibition would not be expected to improve orthostatic BP because little/no neural traffic~     would be transmitted to the pre-synapse. However, individuals with an incomplete autonomic~     lesion may benefit from this class of agent. Researchers are currently investigating the~     orthostatic BP effects of acetylcholinesterase inhibition with pyridostigmine bromide (60~     mg) in 10 individuals with complete (AIS A) and 10 individuals with incomplete (AIS B, C, &~     D) SCI.~   "
57268|NCT02307513|"~     Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout~     the body. The signs and symptoms of Behcet's disease may include mouth sores, eye~     inflammation, skin rashes and lesions, and genital sores that vary from person to person and~     may come and go on their own. The exact cause of Behcet's is unknown, but it may be an~     autoimmune disorder, which means the body's immune system mistakenly attacks some of its own~     healthy cells.~      This study will test whether apremilast is better than placebo (inactive substance in the~     same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's~     disease. Other manifestations of the disease will also be assessed, such as, pain and~     tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also~     will test how well the body tolerates apremilast.~      This study is a randomized, placebo-controlled, parallel design. About 204 subjects will~     participate. The placebo-controlled period will be 12 weeks long and patients will receive~     apremilast or placebo. After the 12-week placebo-controlled period, all subjects will~     receive apremilast for 1 year. All subjects will have their final study visit 4 weeks after~     stopping apremilast treatment.~   "
57269|NCT02307500|"~     This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib~     in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma,~     sarcoma who have progressed after standard therapy.~   "
57270|NCT02307487|"~     A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is~     designed to carefully assess the safety of successive cohorts of patients (3~     patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical~     instillations.~   "
57271|NCT02307474|"~     This pilot clinical trial studies the side effects of stereotactic body radiation therapy~     and pazopanib hydrochloride in treating patients with kidney cancer who are not able to~     undergo surgery. Stereotactic body radiation therapy is a specialized radiation therapy that~     delivers high doses of radiation directly to the tumor and may kill more tumor cells and~     cause less damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor~     cells by blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before~     stereotactic body radiation therapy may help make the tumor smaller and be an alternative~     treatment for patients who cannot undergo surgery.~   "
57272|NCT02307461|"~     To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on~     the Pharmacokinetics of IPI-145~   "
57273|NCT02307448|"~     This investigation plans to initiate the healing of chronic wounds by providing a~     concentrated platelet and growth factor therapy directly to the wound site by topical~     delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an~     emerging surgical and wound care treatment. This investigation aims to demonstrate that~     patients with chronic, non-healing wounds treated with autologous PRP and standard medical~     care have a reduction in wound volume and improved healing rate that results in~     patient-centered clinically significant health outcomes as compared to patients treated with~     standard medical care only.~   "
57617|NCT02302963|"~     This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop~     versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type~     1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.~   "
57274|NCT02307435|"~     Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue.~     Although MSC derived from autogenic bone marrow are proven to help regeneration in non union~     fracture and long bone defect, the aspiration process through iliac crest is invasive and~     painful.~      Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical~     cord is a waste product that proven to contain enormous MSC. Furthermore adipose and~     umbilical cord as an allogenic source is more abundant in number compares to autogenic bone~     marrow. This enormous source need and adequate preservation technique before applied to the~     patient. According to that, researchers want to explore the potency of MSC from bone marrow,~     umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation~     technique to the viability and quality of MSC. We will also compare the effectivity of MSC~     implantation from bone marrow, umbilical cord and adipose applied to non union fracture and~     long bone defect.~      Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the~     cells are observed. Some of the cells are implanted directly to the patient with non union~     fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree~     Celsius in three months. All samples are thawed and the viability of the cells are observed.~     Patient who are implanted by MSC allogenic will undergo clinical and radiological~     examination in the third, sixth and twenty second month after implantation.~   "
57275|NCT02307422|"~     The design and purpose of the current study is to expand and validate previous findings that~     the IL-1 gene cluster composite genotype patterns potentiate the risk for coronary artery~     disease (CAD) and cardiovascular events mediated by OxPL and Lp(a). A secondary objective is~     to validate other, non IL-1 genetic variants associated with CAD.~   "
57276|NCT02307409|"~     This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in~     relation to the evidence of sepsis in liver disease, and compares the accuracy of various~     available laboratory tests in assessment of these patients. Further research is needed for~     proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on~     Chronic Liver Failure) patients in particular, to correctly identify the type and optimal~     quantity of blood product requirement in at risk patients.~      Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly~     diagnose and help guide resuscitation with blood products. Secondly, the study of~     derangement in coagulopathy after the onset of sepsis is of paramount importance because of~     increased mortality after the onset of sepsis. In the present study, patients with ACLF~     (Acute on Chronic Liver Failure) without evidence of sepsis on admission will be included in~     the study cohort, and will undergo a baseline diagnostic workup as described. They will be~     followed for development of any signs of infection after hospitalization. Then the effect of~     sepsis on their coagulation and haematopoietic cellular responses will be assessed. Thus the~     effect of sepsis on the progression and outcome of patients with ACLF (Acute on Chronic~     Liver Failure) will be studied.~   "
57277|NCT02307396|"~     The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention~     should be continued and to which time a patient with schizophrenia is protected enough, so~     that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as~     primary outcome.~   "
57278|NCT02307383|"~     The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus~     Biphidus) administered orally is an effective strategy of intestinal decolonization of~     Enterobacter produced OXA-48-type carbapenemase.~      The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for~     the intestinal decolonization of people who carried Klebsiella pneumoniae produced~     OXA-48-type Carbapenemase.~   "
57279|NCT02307370|"~     The primary objective for this study is to prove the safety and effectiveness of the~     Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with~     catheter to vessel sizing of at least 50%.~   "
57280|NCT02307357|"~     Habitual physical activity was found to be positively related to better health and~     well-being. One of the most popular physical activity forms is ball games. In Israel, there~     is a growing popularity in a new ball game - Newcomball - which is being played by many~     middle age, non-athlete, women. However, so far, no study had evaluated the contribution of~     the game to improvement in the participants' physical fitness. The aim of this study,~     therefore, is to evaluate the effects of six month two weekly Newcomball training sessions~     to the physical fitness of middle age women.~   "
57281|NCT02307344|"~     The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic~     Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.~   "
57282|NCT02307331|"~     The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem~     used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom~     polyethylene, and OptiPac/OptiVac bone cement mixing systems.~   "
57283|NCT02307318|"~     A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal~     hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated~     using 4 French radial sheath. There was no evidence of radial artery occlusion in this small~     sample and bleeding was limited to grade 1. This evidence supports a larger retrospective~     study to confirm these results and define an alternative to the TR band use post radial~     artery access for cardiac catheterization.~      Primary Objective Determine the incidence of arterial bleeding after real-world use of~     SoftSeal hemostatic device at a transradial access site with a 4 French system with with~     manual pressure by compression of the ulnar artery.~      Secondary Objective Determine the incidence of thrombosis at the access site in all subjects~     as presence of thrombus in the radial artery by reverse barbeau test; the incidence of~     changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted~     hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.~   "
57299|NCT02307110|"~     This study is designed to evaluate the prevalence of different stages of diabetic~     retinopathy and diabetic macular edema among patients suffering from type 1 diabetes (DM 1)~     for 5 to 25 years and have been treated with intensified insulin therapy aiming near-normal~     blood glucose levels for the whole duration of disease.~      Prevalence of different stages of diabetic retinopathy and diabetic macular edema is~     assessed using the modified Airlie House classification and the Early Treatment Diabetic~     Retinopathy Study (ETDRS) retinopathy severity scheme. Results of this study will provide~     the basis for designing further studies as well as staging and screening guidelines for~     diabetic retinopathy/diabetic macular edema.~   "
57284|NCT02307305|"~     Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause~     impairment in quality of life and functional capacity after total knee arthroplasty(TKA).~     Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown~     to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and~     spinal cord are believed to both mediate core mood symptoms and help regulate the perception~     of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain~     perception, may be due to increasing the activity of serotonin and norepinephrine in the~     central nervous system. Approved for the acute and maintenance treatment of major depressive~     disorder, the acute treatment of generalized anxiety disorder, the management of diabetic~     peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).~      Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84)~     with those in non-duloxetine group (n=84). Investigators will classify the participants in~     to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the~     degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively~     3 and 6 months). All participants will receive postoperative pain control after TKA using~     the same pain control regimen except duloxetine.~   "
57285|NCT02307292|"~     This is a prospective, non-randomized post market surveillance registry designed to document~     the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular~     Self Expanding Stent System~   "
57286|NCT02307279|"~     This study will asses the decrease in body weight after repeated administration of~     Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.~   "
57287|NCT02307266|"~     This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The~     main objective of this study is to evaluate the effect of a supplementary patient education~     intervention (in addition to the standard-of-care patient education) on treatment adherence~     and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary~     care clinics.~   "
57288|NCT02307253|"~     This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in~     nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for~     the acquisition of samples for histologic analysis. Patients with lesions that can be~     approached only from the duodenum will be prospectively enrolled.~   "
57289|NCT02307240|"~     This is a Phase I, open-label, multi-center trial designed to evaluate the safety,~     tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with~     advanced/relapsed solid tumors.~   "
57290|NCT02307227|"~     Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally~     advanced breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus~     paclitaxel and then if responding further 12 weeks and then with surgical resection,~     patients with HER2 negative breast carcinoma will be treated with 4 cycles (12 weeks) of~     epirubicin and taxotere. If responding 4 more cycles (12 weeks). Patients progressing will~     be treated depending on physician's and patient's preference~   "
57291|NCT02307214|"~     Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and~     chronic cardiac conditions whose clinical presentation, mimicking the onset of acute~     myocardial ischemia in absence of epicardial coronary disease, has progressively gained the~     interest of the scientific community. However, despite significant progress, their~     underlying pathophysiology, which seems to evoke some similarities, still remains elusive.~     Endothelial dysfunction and autonomic imbalance have both been individually implied in their~     puzzling pathogenesis.~      The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and~     healthy volunteers with the following primary objective: to assess the response of~     endothelial function (through the Endopat score) to the autonomic tone activation induced by~     a 10-minute stress mental test. The assessment of autonomic tone during activation through~     the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with~     endothelial function (Endopat score) will represent secondary objectives.~      Our study will enroll 15 patients with TTC at least six months after the event, 15 patients~     with classic CSX and 15 healthy volunteers who will serve as control.~   "
57292|NCT02307201|"~     There is no evidence that patients receiving magnesium sulfate before birth are required to~     maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical~     study in patients with severe preeclampsia who have been treated with impregnation of~     magnesium sulphate and at least eight hours have received the drug before birth. If the~     patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours~     postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other~     anticonvulsant drugs. This study can be conducted in 12 maternity latin america.~   "
57293|NCT02307188|"~     This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the~     left and right atria to explore atrial signal characteristics that can guide atrial~     fibrillation and atrial flutter ablation procedures more effectively.~   "
57294|NCT02307175|"~     Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m~     pertechnetate produced by high energy cyclotron at CHUS.~   "
57295|NCT02307162|"~     The purpose of the study is to assess the safety of single doses and multiple doses of a new~     formulation of RPL554 in healthy subjects and subjects with chronic obstructive pulmonary~     disorder.~   "
57296|NCT02307149|"~     The study will use the established dose of CAVATAK with ipilimumab in patients with advanced~     melanoma for whom ipilimumab would be considered standard of care. Treatment with CAVATAK~     will be on days 1, 3, 5 and 8 and then both agents will be co-administered on days 22, 43,~     64 and 85. Patients with clinical benefit can continue CAVATAK every 3 weeks for up to one~     year,~   "
57297|NCT02307136|"~     This multicenter cohort aims to assess the impact of within-hospital trajectories of~     patients admitted in intensive care units from emergency departments on vital prognosis of~     patients, duration of hospital stay and hospital costs.~      As secondary objectives, the study will:~        -  assess the impact of clinical and demographic characteristics on hospital trajectories~          of patients.~        -  assess the impact of emergency units workload, beds availability in medical units and~          in intensive care units, and global hospital organisation on patients care~          trajectories.~   "
57298|NCT02307123|"~     The primary aim of this study was to describe the long-term outcome of critically ill or~     severely injured patients not in cardiac arrest treated by an EMS physician.~   "
57300|NCT02307097|"~     The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety~     disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the~     National Institute of Health and Clinical Excellence (NICE) as the first-line psychological~     intervention for social anxiety disorder. The treatment aims to modify several maintenance~     factors (e.g., self-focused attention) that are specified in cognitive models of social~     anxiety disorder (e.g., Clark & Wells, 1995).~      Cognitive-behavioural self-help treatments for social anxiety disorder have been developed~     to overcome various accessibility issues (e.g., long wait-lists, and the patient's need to~     avoid social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009;~     Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014)~     identified the former as less cost-effective than the later and thus, they are not~     recommended as standalone treatments.~      However, the potential benefit of cognitive-behavioural self-help treatments for social~     anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has~     not been formally evaluated.~      The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB;~     pure self-help book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients~     with social anxiety disorder while on the wait-list for high-intensity CBT within an~     Improving Access to Psychological Therapies (IAPT) service, and to determine if some~     patients recover from CBB alone or whether there may be a reduction in the average number of~     high-intensity CBT sessions for those patients who subsequently require further treatment.~      The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and~     Talking Change (Solent NHS Trust).~      * The Reading Well Books on Prescription scheme with funding from the Arts Council England~     enables general practitioners (GPs) and mental health professionals to prescribe seminal~     CBBs for patients with mood and anxiety disorders. The books are accessed free of charge via~     local libraries. The scheme works within NICE guidelines and it is support by the Royal~     Colleges of GPs, Nursing and Psychiatrists, the British Association for Behavioural and~     Cognitive Psychotherapies and the Department of Health through its IAPT programme.~   "
57301|NCT02307084|"~     The long saphenous vein is traditionally harvested for use as a conduit in coronary artery~     bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery.~     This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to~     improve patient and clinical outcomes.~   "
57302|NCT02307071|"~     This study evaluates the effect in chronic migraine patients of daily 20~     minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.~   "
57303|NCT02307058|"~     The BLaStM clinical trial extends the Phase I LEAD trial and compares the LEAD upfront~     technique for increasing dose to the MP-MRI defined GTVs to the HEIGHT method of using a~     moderate hypofractionated simultaneous integrated boost to the MP-MRI defined GTVs through~     the course of radiotherapy. The hypothesis is that alternate mechanisms of cell death,~     including bystander effects, are put in place when doses above 8 Gy per fraction are used in~     a lattice and that the effects on local tumor eradication will be greater using this~     strategy.~   "
57304|NCT02307045|"~     The integrity of endothelial glucocalyx plays a vital role in vascular permeability and~     inflammation. Smoking cessation is related with improved vascular function and is a key~     component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of~     evidence based smoking cessation treatment. This study was designed to determine the effects~     medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking~     cessation programs~   "
57305|NCT02307032|"~     Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence~     increases significantly after 80 years of age. After the appearance of first episode(s) some~     of the patients will present frequent arrhythmia recurrences moving from the paroxysmal~     status to the persistent and the permanent status of the continuous spectrum of the natural~     time course of AF. In contrast some other will not present further relapses. To study and~     predict the dynamic evolution of AF is clinically important, furthermore, the detection of~     different sub populations risk for AF relapses will determine and different therapeutic~     approaches.~   "
57306|NCT02307019|"~     The purpose of this study is to analyze the effects of a intervention on a specific health~     prevention/intervention program aimed at caregivers of mild and moderate patients post~     stroke with upper limb apraxia in comparison to a control group with a no specific formation~     in that kind of patients.~   "
57307|NCT02307006|"~     The study is a randomized double-blinded study comparing ceftaroline to standard of care~     therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and~     cardiac surgeries. Study participants will be enrolled from those undergoing cardiothoracic~     surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip~     or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or~     cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions~     and placebo cephalosporin infusions. The primary end point will be the development of a~     surgical site infection within 30 days of surgery.~   "
57308|NCT02306993|"~     This research study has two purposes. The first purpose is to determine whether having~     sickle cell trait (SCT) is a risk factor for the development of bone thinning at an earlier~     age than expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of~     them are unaware of it. African Americans are less likely to develop thin bones than whites,~     but if they sustain a bone fracture, they are more likely to die from it. We believe having~     sickle cell trait may lead to bone thinning and predispose a subset of African Americans to~     dangerously thin bones. The second purpose is to try to understand why individuals with~     sickle cell disease (SCD) have thinner bones than healthy individuals do. Doctors have~     already discovered that people with sickle cell disease have very thin bones, but they have~     not determined why. Our study will try to identify whether the bone thinning is from the~     body not making enough bone or from the body losing bone once it is made.~   "
57309|NCT02306980|"~     Oropharyngeal administration of mother's colostrum to premature infants has been proposed as~     a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and~     sepsis, particularly in intubated babies. We propose to study the impact of this~     intervention on the composition of the oral microbiota.~   "
57310|NCT02306967|"~     Studies from Vancouver show that fluorescent visualization (FV) is a useful method of~     controlling surgical margins. This early finding will now be confirmed in a national~     randomized controlled trial.~   "
57311|NCT02306954|"~     All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the~     first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.~     Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday~     before the Monday on which IL-2 starts.~   "
57312|NCT02306941|"~     This pilot-study aims to evaluate the treatment effects and feasibility of an~     internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and~     functional dyspepsia.~   "
57697|NCT02301923|"~     This study aims to determine the average compliance of a patient under CPAP therapy for~     obstructive sleep apnea as well as the various factors that influence it.~   "
57313|NCT02306928|"~     Antibiotic dosing in septic shock patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      We determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 15 patients~     treated empirically for septic shock. A PK population model was established with the dual~     purpose to assess current standard treatment and to simulate alternative dosing regimens and~     modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted~     for each patient were evaluated against clinical breakpoint MIC for Pseudomonas aeruginosa~     (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and~     50% fT>4xMIC.~   "
57314|NCT02306915|"~     Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian~     participants for the sake of matching. Every effort will be made to match Caucasian and~     Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to~     maintain balance between male and female participants within the cohorts. There will be no~     replacement of participants following randomization.~   "
57315|NCT02306902|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules,~     USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate)~     capsules 130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient~     Pharmaceuticals Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed~     condition.~   "
57316|NCT02306889|"~     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,~     two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate~     capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical~     Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA,~     in healthy, adult, male, human subjects under fasting condition.~   "
57317|NCT02306876|"~     This study is designed to investigate the safety, tolerability pharmacokinetics and~     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets~     in healthy adult males.~   "
57318|NCT02306863|"~     This study will evaluate whether whole-body vibration applied over a 12-week period is~     effective in treating motor symptoms of Parkinson's disease.~   "
57319|NCT02306850|"~     This study is being done to see if using the study drug, pembrolizumab, can shrink down~     melanoma tumors enough so that they will be small enough to cut out, so that there will be~     no cancer left in the body.~      Eligible participants include those who have not received any systemic melanoma therapies~     (i.e. participants do not have to fail ipilimumab or BRAF inhibitor) and those who have~     failed all available systemic options (if the participant meets other inclusion / exclusion~     criteria).~   "
57320|NCT02306837|"~     To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical~     trial to test the efficacy and feasibility of consolidation chemotherapy after autologous~     stem cell transplantation~   "
57321|NCT02306824|"~     Investigator-initiated prospective multicentre hospital-based registry to uncover the~     proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and~     assessing the proportion of stroke, intracranial bleeding and all-cause death in the short~     (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic~     stroke or transient ischemic attack in an unselected urban population in Germany.~   "
57322|NCT02306811|"~     Primary Objective:~      To assess the long-term safety of vatelizumab in MS patients~      Secondary Objective:~      To assess the long-term efficacy of vatelizumab~   "
57323|NCT02306798|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine~     [9] subjects will be evaluated. The subjects will receive one [1] radio-labelled tablet~     after a high fat and a rich in calories breakfast.~   "
57324|NCT02306785|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with~     mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be~     evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1]~     radio-labelled tablet of either formulation D or formulation E, respectively.~      Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects~     and five [5] patients will be administered one [1] radio-labelled tablet of this new third~     improved formulation H.~      In order to keep the number of patients low, recruitment of patients will be stopped when~     obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will~     then be recruited to achieve a full set of participants (n=9 per Arm).~   "
57325|NCT02306772|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine~     [9] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will~     be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive~     formulation B and the second 9 subjects will receive formulation A. The subjects will be~     treated once with the radio-labelled study medication.~   "
57341|NCT02306564|"~     The purpose of this study is to determine the effect of giving cabergoline to patients at~     risk of OHSS (ovarian hyperstimulation syndrome) after ovum pick up, on endometrial~     vascularity and it's effect on pregnancy outcome~   "
57360|NCT02306304|"~     The study aims at screening Israeli Arab men, smokers or past smokers, for abdominal aortic~     aneurysms (AAA).~      The screening is to be performed at the family doctors clinics in the rural arab erea of the~     north of Israel.~      Goals:~      The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab smoking~     men population. By revealing this prevalence we believe the need for a nation-wide screening~     program for AAA will turn available for assessment.~      In addition, the goal of improving the accessibility of health services for the Israeli Arab~     population is a key issue in the design of the research.~      2000 patients are to be enrolled in the study over a period of 2 years. Each of the patients~     will be examined once for a duplex ultra-sound and will be classified into one of 4~     sub-groups according to the maximal aortic diameter found.~   "
57361|NCT02306291|"~     This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid~     leukemia in combination with standard agents used to treat this disease.~   "
57326|NCT02306759|"~     The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine~     versus morphine alone for acute generalized pain in the Emergency Department (ED). The~     investigators are also interested to investigate whether low-dose ketamine is a safe and~     effective alternative option to opioids for the acute treatment of pain in the Emergency~     Department.~      The agents that are available in the department includes acetaminophen, non-steroidal~     anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not~     adequate to manage acute pain crisis. There is also heightening concerns for increased~     opioid use or abuse by patients. Since the HCAPHS survey includes various questions which~     inquires about patient perception of pain management in the department, the investigators~     are interested in investigating the safety and efficacy of low-dose ketamine to as an~     alternative method to opioids for the acute management of pain. There has been limited,~     mostly observational pilot studies, published in the literature. Limited data in the~     literature have reported the incidence of nausea and vomiting ranged from 3-13%. All~     published literature administered low-dose ketamine as an intravenous push. To the best of~     our knowledge our study would be the first study to administer low-dose ketamine as a short~     bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe~     our study would provide important scientific data to fill the theoretical gap that low-dose~     ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an~     ED that is located in the center of a densely populated urban area.~   "
57327|NCT02306746|"~     Nutrition therapy is an essential standard of care for all critically ill patients who are~     mechanically ventilated and remain in the intensive care unit for more than a few days.~      The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial~     to determine if augmentation of calorie delivery using energy dense enteral nutrition in~     mechanically ventilated patients improves 90 day survival when compared to routine care.~   "
57328|NCT02306733|"~     200 women with PPH will be randomly divided into 2 equal groups using computer generated~     random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland)~     and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The~     investigators will not include a control group for ethical reasons.~   "
57329|NCT02306720|"~     To collect information on the variability, progression, and natural history of HPP from~     patients of all ages, including infants, children, and adults with HPP, regardless of age at~     onset.~   "
57330|NCT02306707|"~     A patient referred to have a lesion in the stomach removed. The aims of this study are to~     collect information on the technique of endoscopic removal of such lesions. By collecting~     information on a large number of patients undergoing this procedure the investigators can~     determine the best ways of diagnosing and removing these lesions safely and effectively.~   "
57331|NCT02306694|"~     One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture~     outcome data demonstrating the clinical significance of decreased BMD and altered bone~     biomarkers in the hemophilia population. This study demonstrates that PwH have an increased~     risk of fracture compared to the general population and that the issue of bone health will~     increase in importance as the PwH population ages.~   "
57332|NCT02306681|"~     This study is conducted globally. The aim of this study is to describe the proportion of~     patients with hypoglycaemic episodes and estimate the incidence of various types of~     hypoglycaemia in the retrospective and prospective periods.~   "
57333|NCT02306668|"~     The investigators seek to characterize the identity of all microorganisms residing on the~     eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a~     combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the~     vast majority of cases the cause of the chronic inflammatory condition is unknown.~   "
57334|NCT02306655|"~     Fundamentals of scientific research The coital incontinence (IC), defined as the~     involuntary loss of urine in association with sexual intercourse. The incidence reported~     in the literature ranges from 10% to 27%, but is likely to be underestimated because of the~     embarrassment of the woman to report the disturbance. It was in fact estimated that only 3%~     of women speaks spontaneously to their doctor, and increases up to 20% only after a request~     by the medical staff.~      The CI is traditionally divided into two forms:~        1. incontinence at the time of penetration (60% of cases)~        2. incontinence during orgasm (40% of cases) Many theories have been proposed to justify~          this form of urinary incontinence, but none has been conclusively proved .Moreover, it~          has not been possible, to date, to identify risk factors, anatomical or urodynamics,~          for this condition.~      The IC is rarely a symptom isolated, but more frequently associated with other forms of~     urinary incontinence. In particular, the IC during penetration of associated with stress~     urinary incontinence (loss of urine that occurs due to coughing, sneezing and in general to~     all those activities that increase abdominal pressure); the IC during orgasm is associated~     more frequently to a condition of overactive bladder (presence of urgency, urge~     incontinence, increased urination day and night).~      The IC has a strong impact on female sexuality and can cause loss of libido, non orgasmic,~     decreased sexual satisfaction and, in some cases, termination of sexual activity.~      Research goals Evaluate a prospective investigation of health statistics, the incidence of~     coital incontinence into consideration that there are few data in the literature on this~     disorder and those who have reported a wide variance probably connected to how the data~     collection. The aim is to be able to identify a threatening condition which, if not~     evaluated, worsens the prognosis of the treatment of female urinary incontinence, a~     condition that has a negative impact on the quality of life of patients with significantly~     worse than that related to other recognized debilitating chronic diseases such as diabetes.~      And this individual psychosocial cost, hardly quantifiable, must be added the cost of~     significant socio-economic and welfare dependents of incontinent patients, the community and~     national health services. It is indeed evident from international and national literature~     that the more incisive and determined is the strategy of information, awareness and~     education, and adopted much wider and earlier the diagnosis, the more significant is the~     socio-economic savings, as well as psycho social, we get.~      Ultimate goal is to differentiate between them the two forms of incontinence coital (to~     penetration and during orgasm) because each of them is associated with pathogenesis and~     therefore to a separate treatment. And while the forms of IC penetration favorably affected~     the treatment of stress urinary incontinence, the forms of IC during orgasm, usually~     associated with a functional disorder of the detrusor (detrusor overactivity) show an~     inferior efficacy to treatment antimuscarinic traditionally reserved to the condition of~     overactive bladder and therefore need a more targeted diagnostic and individualized~     treatments.~      Materials and methods~      Self administered questionnaires will be dispensed to the patients The~     questionnaires,validated in Italian language, will be used, according to the guidelines of~     the International Consultation on Incontinence, :~        -  ICIQ-UI on urinary incontinence short-form: for the evaluation of symptoms and quality~          of life:~        -  Patient Perception of Bladder Condition (PPBC): to assess the impact of such a~          subjective condition;~        -  Urinary incontinence and quality of sexuality;~        -  Urinary incontinence and frequency of sexual activity; The questionnaire is anonymous~          in order to protect privacy. The patients will be recruited at the outpatient surgery~          and Urogynaecology urodynamics of Urology Clinic of the University of Perugia.~      The investigators defined that the statistically significant number of subjects can not be~     less than 200 units.~      The time duration of the collection of medical records was estimated at two years.~      There are no extremes of the conflict of interest, will not be tested or used drugs or~     medical equipment.~   "
57335|NCT02306642|"~     The purpose of this study is to learn more about how to identify signs of early chronic~     kidney diseases in children who were born prematurely with low birth weight (less than 3 ½~     pounds). Researchers plan to compare the kidney function in children who experienced acute~     kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not~     experience it. Evidence from several studies and our experience at UVA show that older~     children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have~     increased risk of developing early chronic kidney disease, and they also show early changes~     in the urine and blood that is consistent with early chronic kidney disease. In this study,~     the investigators hope to determine if any of these changes can be detected in early~     childhood, and if so, at what age we can start detecting these changes.~   "
57336|NCT02306629|"~     To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety~     and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to~     when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.~   "
57337|NCT02306616|"~     To develop and implement quality improvement programs for the treatment of acute coronary~     syndrome (ACS) in China based on the successful experience of the AHA-Get with the~     Guidelines program. This two-year program will use data collection, analysis, feedback, and~     process improvement to extend the use of evidence-based guidelines throughout the healthcare~     system and improve patient care of acute coronary syndrome.~   "
57338|NCT02306603|"~     This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions~     in the duodenum and ampulla'. The research project is aiming to determine the most effective~     and safe way to remove such lesions.~   "
57339|NCT02306590|"~     The primary objective of the trial is to investigate the survival time (the time from~     randomization until death or date of end of the study) compared between control group and~     experimental group.~      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind~     trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100~     mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the~     El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable~     on riluzole at least 4 weeks prior to randomization.~   "
57340|NCT02306577|"~     The SINNR study will evaluate the virologic efficacy (viral load <50 copies/mL)and safety of~     STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.~   "
57342|NCT02306551|"~     The purpose of this study is to establish a cohort of pregnant women with severe mental~     disorder and to identify biological and psycho-social transmission mechanisms involved in~     the development of 'risk' and 'resilience' in the offspring. It is assumed that both~     'resilient' and 'risk' development in offspring are caused by a complex interaction between~     multiple biological, psychological and social factors. The project focuses specifically on~     exploring the impact of physiological stress-sensitivity, attachment, care-giving and the~     familial and social context for care-giving. Previous studies support these factors as~     important for the development of these infants, but systematic research using a prospective~     design is needed to strengthen evidence and elucidate the importance of these factors in~     more detail. The interaction over time of physiological stress-sensitivity, attachment,~     care-giving and the familial and social context for care-giving are evaluated in terms of~     the evolution of very early indicators of developmental risk and resilience in infants with~     a known highly increased risk for developing a mental disorder.The findings of the study may~     potentially lead to more specific targets for preventive interventions, which can improve~     developmental outcome for these infants.~   "
57343|NCT02306538|"~     Breast cancer is the most common cancer amongst Canadian women. 15-20% of early breast~     cancers have high levels of a protein called HER2 which is associated with worse survival.~     Treatment of these patients with anthracyclines followed by trastuzumab (which targets HER2)~     improves survival. Unfortunately, these medications together can cause heart muscle injury~     resulting in heart dysfunction or failure in about 14% and 3.6% of the patients,~     respectively. Once heart failure (HF) occurs, about 60% of patients will not live past 2~     years. Studies have suggested that patients with heart injury caused by anthracyclines may~     be more likely to develop HF with addition of trastuzumab. Therefore tests to find early~     heart injury after anthracyclines may allow doctors to start heart protective medications~     with the hope of preventing HF. Also, animal and small patient studies have shown that an~     increase in the water levels of the heart muscle (edema) may be an early sign of heart~     injury from anthracyclines. Cardiac MRI is a unique technique that has been shown to detect~     edema in various heart diseases.~      The investigators will test the theory that, in women receiving treatment for breast cancer,~     heart edema detected by MRI at the end of anthracyclines will identify patients who will~     later develop heart dysfunction. MRI studies with novel techniques will be done pre-therapy,~     after anthracyclines, during herceptin, and at end of all therapy. The investigators will~     compare patients with and without heart dysfunction to test if patients with heart~     dysfunction are more likely to have edema after anthracyclines. Ultimately the investigators~     hope to use cardiac MRI to identify high risk patients and study various heart protective~     medications to prevent HF. This will improve the personal health of cancer patients by~     allowing them to live free of heart disease after their cancer therapy. Ultimately at a~     population level this will allow doctors to provide care that can be uniquely designed for~     each patient based on their individual risk.~   "
57344|NCT02306525|"~     Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months~     after arthroscopic surgery for FAI and compare the results to people without hip problems.~      Methods/design: Sixty patients with FAI and 30 persons without hip problems will be~     included. Pre- and postoperatively, patients will be evaluated by CT-scans. All participants~     will have their hip flexor and extensor muscle strength assessed and have performed kinetic~     and kinematic analyses of daily activities with 3D motion capture. Further, self-reported~     questionnaires on hip related pain, quality of life and sports activities will be collected.~     Finally, participants will have their daily physical activity monitored with tri-axial~     accelerometers for five consecutive days.~      Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of~     FAI within one year after surgery will be evaluated. If the patients fail to reach reference~     values one year after surgery, altered surgical procedures or rehabilitation programs to~     optimize treatment for the patients may be explored in future studies. Further, the~     investigators expect to perform long-term follow up to evaluate reoperations, conversions to~     total hip arthroplasty and development of osteoarthritis for the patients surgically treated~     for FAI.~   "
57345|NCT02306512|"~     The purpose of this study is to determine if immunofluorescence (IF) can effectively~     identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs~     Micrographic Surgery.~   "
57346|NCT02306499|"~     This study will include cryopreserved sperm from infertile azoospermic men, with proven~     diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART~     program in Sohag. Patients personal and medical history and socio-demographic data will be~     retrieved from their saved medical files.~   "
57347|NCT02306486|"~     The aim of this double-blind randomized controlled clinical trial was to evaluate the effect~     on dentin sensitivity using oxalic acid desensitizing agent before restoring with~     resin-based-composites, during one-year follow-up. One hundred and twenty two cervical~     lesions (31 patients, age range between 24 and 66 years) were selected and randomly divided~     into four groups: OA/Z250: treated with acid oxalic desensitizing agent (Desenssiv, SSWhite)~     before restoring with a methacrylate resin-based-composite (Z250, 3M ESPE), (n=31), OA/P90~     treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a~     silorane resin-based-composite (Silorane p90, 3M ESPE) (n=31), Z250 restored with~     methacrylate resin-based-composite (Z250, 3M ESPE) (n=30) and P90 restored with a silorane~     resin-based-composite (Silorane p90, 3M ESPE) (n=30). All lesions were evaluated at~     baseline, immediately and 1, 2, 3, 6 months and 1 year after treatment. Teeth sensitivity~     was measured by visual analog scale (VAS) after evaporation and tactile stimuli~   "
57348|NCT02306473|"~     This is a clinical trial designed to test the hypothesis that measuring the absorption and~     excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial~     permeability in asthma.~   "
57349|NCT02306460|"~     Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke.~     There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively,~     left atrial appendix closure can be used, if the risk for bleeding complications is deemed~     greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of~     ischemic complications can be prevented with anticoagulation therapy, and left atrial~     appendix closure seems to have comparable results. Also left atrial catherter ablation~     (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation.~      However, the procedure is associated with 0,5-1% perioperative risk of clinically evident~     transient ischemic attack (TIA) or stroke. While the incidence of clinically evident~     ischemic complications remain relatively low, recent data suggest that 13%-20% of patients~     undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days~     after ablation.~      The goal of the study is to improve detection of subtle brain dysfunction after cardiac~     interventions by employing an experimental executive reaction time (RT) test along with EEG~     recording in aims to improve objective detection of subtle brain dysfunction assumed to~     underlie persistent cognitive, somatic, and affective complaints reported by patients who~     have undergone atrial fibrillation ablation.~   "
57351|NCT02306434|"~     Childbirth related fear is a public health issue strongly related to subsequent~     reproduction, a request for caesarean section and women's and children's health. Currently,~     women are offered 3-5 counseling sessions with specially trained midwives and obstetricians~     in most Swedish hospitals as standard care (SC). In general, women are satisfied with~     counseling but research show no major effect on cesarean section rates neither in decreased~     level of childbirth related fear. It is therefore important to find the best available~     treatment for this issue.~      The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with~     standard counseling care for pregnant women reporting childbirth related fear.~      Research questions: What effect does ICBT compared to SC have on a) the level of childbirth~     related fear b) a request for cesarean section c) compliance and satisfaction with~     treatment.~      Design: A randomized controlled trial of women reporting childbirth related fear during~     pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of~     given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after~     birth. Intervention: The intervention will focus on management of childbirth related fear.~     This means that the participants do weekly sessions and homework assignments during~     pregnancy.~      Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.~      Secondary outcomes are level of childbirth related fear at 2 months and one year after~     birth, preferences for mode of birth, request for elective cesarean section, compliance and~     satisfaction with treatment and costs.~      Expected benefits: This study will contribute to the development of new treatment methods~     for childbirth related fear. Evidence of the best treatment to reduce childbirth related~     fear based on the results from this study could be implemented in clinical practice and~     hopefully decreases the numbers of cesarean sections without medical indications.~   "
57352|NCT02306421|"~     Simplified Milligan-Morgan is a surgical option which was improved and developed by~     Professor He,well-known traditional Chinese doctor from Hunan province,based on~     Milligan-Morgan.RPH is a new therapy for hemorrhoid following the improvement of rubber band~     ligation.RPH +Simplified Milligan-Morgan is one of important means of modern surgery.The~     operation method was improved and developed on the basis of Chinese medicine traditional~     loop ligature and it also embodies uniqueness and advantage of the treatment of mixed~     hemorrhoids combined traditional Chinese and Western Medicine.The study intends to compare~     five surgery ways through 3000 cases of patients with mixed hemorrhoid from 12~     hospitals,observing the efficacy and safety of various operative methods.Exploration of RPH~     + Simplified Milligan-Morgan operation indication, contraindication, operation steps and key~     points, and the operation complications and sequelae and treatment etc provide evidence of~     evidence-based medicine for Clinical application.~   "
57353|NCT02306395|"~     The purpose of this study is to determine whether edometrial local injury improves the~     outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of~     intervention,and the possible mechanism.~   "
57354|NCT02306382|"~     Drainage of perianal abscesses is a well established treatment. Traditionally its been done~     in general anesthesia after the swelling has been localised its been drained with a knife.~     After surgical intervention complications can occur with recidivism, chronic fistulas that~     go from the anal to the skin and sometimes the anal sphincter is damaged which can cause~     problems with incontinence.~      Through ultrasound the abscess is opened under more controlled forms with a better visual~     overview. This is a new technique that has not been tested in larger studies. The aim with~     ultrasound-drainage as with traditional incision to drain the abscess so that the infected~     area can heal.~      The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D~     ultrasonography.~   "
57355|NCT02306369|"~     This randomized controlled trial aims to evaluate the treatment effects of an~     internet-delivered CBT-program for adolescents with irritable bowel syndrome.~   "
57356|NCT02306356|"~     An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the~     rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered~     Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting.~     20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation~     anxiety, specific phobia and their parents will be recruited from the CAMHS-center in~     Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by~     clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month~     follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale~     (CGI-S). Secondary outcome measures include clinician rated global functioning, and child~     and parent-rated anxiety and functioning.~   "
57357|NCT02306343|"~     The study is an open-label, randomized, two-period, one-way crossover study using the Meal~     Tolerance Test (MTT) protocol or the daily life setting protocol.~      The study consists of two parts. Subject may participate in both parts or just in one part.~      The first part tests the effect of local heating on the post prandial glucose levels~     following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus~     insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected~     0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin~     measurements was taken from a venous line. The study was conducted twice with (test) and~     without (control) the use of the InsuPad device.~      The second part evaluate the safety and efficacy of the device use at daily life settings.~     Type I and type II diabetic patients enrolled to the study. They will be required to perform~     at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25~     months. Up to one month run in period, up to 12 months with the device (test) and up to 12~     months without the device (control).The subjects will be asked to record events of~     hypoglycemia, hyperglycemia and any adverse events related to diabetes or the study.~   "
57358|NCT02306330|"~     MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood~     cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an~     important new technology that is becoming routine in developed countries. It is currently~     unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing~     countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi~     Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.~   "
57359|NCT02306317|"~     The purpose of this study is to determine whether saturation control by parents in children~     younger than 32 weeks or under 1500 g versus conventional care performed by nursing~     increases the time in which these patients remain at optimal saturation range. If the~     hypothesis of this study is confirmed premature infants could prevent episodes of~     hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their~     children admitted in a neonatal intensive care unit.~   "
57362|NCT02306278|"~     The study is to observe the effects of gabapentin premedication on postoperative~     pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are~     randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or~     placebo orally the night before operation day and 2hours before surgery,respectively.The~     investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be~     observed in GG than GP.~   "
57363|NCT02306265|"~     The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both~     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from~     asymptomatic women undergoing screening mammography. These data will be included in a~     subsequent and prospectively planned pooled analysis described in a separate protocol~     (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other~     clinical performance measures.~   "
57364|NCT02306252|"~     The CARE Program is a randomized trial of a cancer rehabilitation program designed to help~     older cancer patients who have shown to have a loss of function.~   "
57365|NCT02306239|"~     Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to~     severe intesitnal complications such as intestinal ischemia. The investigators study was~     designed to find the effect of terlipressin on intestinal function in septic shock patients.~   "
57366|NCT02306226|"~     Post-market registry aimed at further evaluating the safety and performance of the ACURATE~     neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with~     severe aortic stenosis treated with the commercialized device~   "
57367|NCT02306213|"~     Recent studies have shown an increased incidence of renal replacement therapy after the use~     of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However,~     studies showing detrimental effects of HES have been conducted in mostly non-surgical~     subjects. There are very few studies analyzing the effects of HES on renal function after~     cardiac surgery, a population already at risk of renal dysfunction.~   "
57368|NCT02306200|"~     The goal of this project is to establish a biobank of clinical information, DNA, plasma, and~     aortic tissue samples from patients with cardiovascular disease as well as healthy controls.~   "
57369|NCT02306187|"~     In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment.~     However, the bone turnover markers or the bone mineral density (BMD) are not improved in~     some osteoporotic patients even though they have taken BPs and alfacalcidol more than~     several years. In those case, the investigators better off prescribing BPs and Eldecalcitol,~     instead of BPs and Alfacalcitol.~   "
57370|NCT02306174|"~     The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week~     group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive~     hoarding. The overarching aim is to understand whether this course will decrease the core~     symptoms of hoarding and associated features.~   "
57371|NCT02306161|"~     This randomized phase III trial studies how well combination chemotherapy with or without~     ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to~     other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in~     different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine~     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination chemotherapy is more effective with or without ganitumab in treating patients~     with newly diagnosed Ewing sarcoma.~   "
57372|NCT02306148|"~     The main objective of this trial is to investigate the effects of a training protocol for~     the foot and ankle complex on the prevalence of running related injuries on long distance~     runners.~   "
57373|NCT02306135|"~     mTOR kinase is part of the mTORC1 complex that promotes cap-dependent protein translation,~     and part of the mTORC2 complex that activates AKT. Everolimus (Afinitor) is an allosteric~     inhibitor of mTOR that suppresses mTORC1 activity. Everolimus is FDA-approved for the~     treatment of ER+/HER2- breast cancer (in combination with exemestane), renal cell carcinoma,~     subependymal giant cell astrocytoma (SEGA), and neuroendocrine tumors of pancreatic origin~     (PNET), and is currently being tested in ongoing clinical studies in other indications.~     While everolimus-based therapies elicit anti-cancer effects, most cancers ultimately~     progress and exhibit everolimus resistance. This study will evaluate genetic mechanisms of~     resistance to everolimus.~   "
57374|NCT02306122|"~     This study is a pilot test of an intervention that delivers timely diagnostic information~     about medication nonadherence to doctors, and then offers the services of clinical~     pharmacists to treat these nonadherence problems. Participating doctors will be notified~     when a patient is 10 days late refilling a medication for diabetes, hypertension, or~     hypercholesterolemia. In one randomization arm the pharmacist will contact the patient as~     the default option (with no action required by the doctor), and in the other the pharmacist~     will contact the patient only if the doctor actively chooses that the pharmacist take~     action. Patients of participating doctors will be randomized to 1) one of these two~     pharmacist options, 2) an information only control arm in which the doctor gets adherence~     information but does not have access to a pharmacist for that patient, and 3) a no~     information control arm. The investigators' central hypothesis is that the pharmacist will~     be consulted more often when intervention by the pharmacist is the default outcome and that~     the default pharmacist intervention will be the most beneficial for adherence outcomes.~   "
57375|NCT02306109|"~     ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an intensive~     or standard motor rehabilitation treatment on motor disability in people with ALS~   "
57376|NCT02306096|"~     This study evaluates the genomic profiles of breast cancer in a prospective and~     population-based manner. In the first phase, breast tumors are analyzed by whole~     transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript~     isoform-level data will be analyzed in the context of patient information,~     clinicopathological variables, and outcome, with the purpose to develop new molecular~     diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses~     will be performed in the future.~   "
57377|NCT02306083|"~     In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are~     included. Those with the history of intraocular and corneal surgery, diabetic and heavy~     smokers are excluded from the study. Before starting the treatment all patients undergo~     complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response~     Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to~     treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500~     mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At~     month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.~   "
57378|NCT02306070|"~     HCV antiviral therapy has evolved rapidly in recent years and access to these medications~     has improved. While SVR is associated with improved liver outcomes, the rate of liver~     fibrosis regression with SVR is variable and predictors of regression are not well~     established. In addition, achieving SVR in patients with cirrhosis does not necessarily~     prevent decompensation or eliminate the risk of HCC. A better understanding of the role~     insulin resistance and impaired glucose metabolism have on these outcomes in HCV patients~     who achieve SVR are needed.~      Identifying and targeting potentially modifiable risk factors such as IR may be of~     significant importance in preventing progression of and promoting regression of liver~     fibrosis, reducing mortality and improving outcomes for HCV-HIV co-infected and~     HCV-mono-infected patients.~      This proposed pilot study will be the first to evaluate the role of Metformin on liver~     fibrosis in HCV-HIV co-infected and HCV mono-infected patients with IR receiving DAA HCV~     treatment.~      If Metformin is effective in reducing liver fibrosis in this patient population, this will~     represent a well-tolerated, easy to administer, inexpensive therapy that will protect~     against negative HCV outcomes. This study will also be an opportunity to evaluate the impact~     of insulin resistance and hyperglycemia have on viral clearance HCV-infected patients~     treated with interferon-free regimens. In addition, the study will further explore the~     relationship between HCV, insulin resistance and AFP levels.~   "
57379|NCT02306057|"~     This project will evaluate fluid balance and edema formation in children with congenital~     heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the~     child end up with a univentricular heart with one-chamber circulation ( Fontan circulation).~     This project will evaluate if these children has increased micro vascular leakage before~     surgery due to their congenital heart defect. The project will also investigate if the edema~     formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and~     hypothermia is caused by capillary leakage of plasma protein.~      The study hypothesis are~        1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure~          gradient through the capillary membrane.~        2. The degree of micro vascular leakage in open-heart surgery is related to duration of~          CPB and hypothermia.~        3. Fontan circulation cause peripheral edema related to elevated central venous pressure~          and is not caused by increased micro vascular leakage of plasma proteins.~   "
57380|NCT02306044|"~     The purpose of the study is to investigate whether platelet indices from automated~     haematology equipment, whole blood impedance aggregometry and a standardized bleeding~     questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.~   "
57381|NCT02306031|"~     Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens~     implantation surgery have enrolled. Fifty four eyes have received the conventional~     postoperative care with steroid drop, whereas the other group (54 eyes) have given a~     preoperative diclofenac drop four times daily in addition to steroid drop and continued six~     weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT)~     preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual~     acuity (BCVA) and OCT findings were compared in and between both groups.~   "
57382|NCT02306018|"~     The investigators are trying to evaluate the agreement of cardiac output measurements taken~     using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the~     EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken~     using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic~     liver transplantation.~   "
57383|NCT02306005|"~     The aim of the study is to evaluate the effect of insulin therapy in patients with newly~     diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins,~     with particular emphasis on HDL metabolism, and analysis of the factors determining the~     effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100~     people with newly diagnosed type 1 diabetes and lead prospective observation of this group~     (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization~     in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks,~     after 6 months and after 12 months of insulin therapy. Further observations planned in the~     annual intervals. In addition, the study group will be under constant monitoring of~     metabolic evaluation every three months in the Outpatient Clinic.~      During each follow-up will be assessed parameters evaluating the metabolism of plasma~     lipoprotein fractions and subfractions of HDL:~        1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E~        2. Electrophoresis of plasma lipoproteins~        3. Electrophoresis of HDL~        4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma~          lipoprotein lipase Moreover, evaluation of factors which may potentially modify the~          relation between insulin therapy and lipoproteins will be assessed~             1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip~               ratio, the estimated rate of glucose distribution, VAI index, body fat, blood~               pressure),~             2. Metabolic management of diabetes,,~             3. Protein glycation end products~             4. The concentration of plasma adipokines.~      Expected impact of the research project on the development of science, civilization and~     society The obtained results allow to assess the impact of exogenous insulin on quantitative~     and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1~     diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it~     seem to be very important in the treatment of patients with type 1 diabetes, where insulin~     is the treatment of choice and dosage adjustment appears to be extremely important. Remains~     unknown whether the changes in the lipoprotein profile result from the beginning of insulin~     therapy or other factors influence it. Selecting a group of patients with less favorable~     lipoprotein profile may allow better metabolic control, and thus will affect the quality and~     length of life of our patients. These studies will assess the impact of our therapeutic~     actions on the diagnosis of the disease on long-term consequences, such as the development~     of chronic complications.~   "
57384|NCT02305992|"~     Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney~     transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans~     blood by removing it from the body and passing it through a dialyzer, or artificial kidney.~     To maximize the amount of blood cleansed during hemodialysis treatments, there should be~     continuous high volumes of blood flow. A fistula used for hemodialysis is a direct~     connection of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a~     natural part of the body. This is the preferred type of access because once the fistula~     properly matures and gets bigger and stronger; it provides an access with good blood flow~     that can last for decades. After the fistula is surgically created, it can take weeks to~     months before the fistula matures and is ready to be used for hemodialysis. There have been~     surgical factors identified; one of them being the anesthetic used which may cause a fistula~     not to survive. This study will look at comparing 3 anesthetic techniques: axillary block~     (AB) versus stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).~   "
57385|NCT02305979|"~     The purpose of this project is to assess the efficacy of loratadine in decreasing the~     incidence and severity of bone pain following G-CSF administration in patients with~     hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor~     cells, and patients who have undergone an autologous hematopoietic cell transplant. This is~     a different patient population than those being assessed in current clinical trials.~   "
57386|NCT02305966|"~     Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced~     arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal~     hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the~     upper arm. This orientation is opposite to the normal anatomy, giving rise to the term~     reverse shoulder replacement. While RTSA has a good clinical track record, no studies have~     examined how well fixed the implanted components are within patients.~   "
57387|NCT02305953|"~     Psoriasis is an inflammatory disease involving the skin, the joints and the vascular~     compartment. The mechanisms linking inflammation in the skin and joints and in the vascular~     walls are poorly understood. One hypothesis for the increase in vascular inflammation~     observed in patients with psoriasis involves circulating pro-inflammatory cytokines.~     Patients with psoriasis have an increase in serum levels of tumor necrosis factor alpha~     (TNF-alpha), Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. It is~     possible that one of those cytokines/chemokine induces vascular inflammation in the vascular~     compartment. The purpose of this cross sectional retrospective study is to highlight the~     correlation between vascular wall inflammation using 18F-2-fluoro-2-deoxy-D-glucose -~     Positron Emission Tomography (FDG-PET) fluorodeoxyglucose technology and pro-inflammatory~     cytokines/chemokine.~   "
57388|NCT02305940|"~     This study investigates if long term use of the antibiotic doxycycline can reduce~     exacerbations in COPD patients. Half of the patients will receive doxycycline which the~     other half will receive a placebo.~   "
57389|NCT02305927|"~     The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol)~     supplementation on maternal HIV progression, small-for-gestational age infants, and infant~     stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving~     highly active antiretroviral therapy (HAART).~   "
57390|NCT02305914|"~     This is a follow-up study focusing on long-term complications of acute pancreatitis. The~     primary purposes include: 1. To assess the incidence of type 2 diabetes~     mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after~     acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute~     pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer,~     pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the~     long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration~     O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the~     prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful~     to find the most effective and targeted interventions aiming at different phases after AP~     attack.~   "
57391|NCT02305901|"~     To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs~     repaglinide and bupropion as a means of predicting drug-drug interactions.~   "
57392|NCT02305888|"~     The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1%~     for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and~     trunk/extremities, respectively.~   "
57393|NCT02305875|"~     The investigators have made a favourable experience with the in 2006 published transarterial~     triple injection method [4]. This classic method combines the block effect of an axillary~     catheter injection (median nerve position) with a double transarterial injection at terminal~     nerve level in the axilla.~      The investigators experience after a recent published MRI study [3], confirms that a~     proximal axillary local anesthetic injection via an axillary catheter, guided by nerve~     stimulator, is beneficial for the block effect. The MRI study was conducted using nerve~     stimulation and a transarterial technique. The proximal injection with an effect at cord~     level, combined with axillary injections at terminal nerve level, produce an effective block~     distal to the elbow.~      The proximal injection has obviously an effect to the lateral cord and the musculocutaneous~     nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is~     sufficient for the axillary block [5, 6]. Their block techniques included a selective block~     of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a~     successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of~     15 patients) in the triple injection group without a selective block of this nerve. In the~     1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15~     patients (73%) had the mcn successful blocked.~      The objective in this study (Article 4) is to examine the mean position of the mcn nerve and~     its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal~     directed axillary catheter in median nerve position is beneficial in order to provide a~     successful mcn blockade? Is a selective injection to the mcn at terminal nerve level~     superfluous when a catheter is used?~   "
57394|NCT02305862|"~     The aim of this study is to assess whether high intensive statin therapy could regress~     carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic~     Resonance imaging (CE-MRI).~      Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic~     plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of~     Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again~     and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded~     fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated~     during follow-up.~   "
57395|NCT02305849|"~     The objective of this study is to verify the efficacy of ASP015K versus placebo~     administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in~     patients with rheumatoid arthritis (RA) who had an inadequate response to MTX~   "
57396|NCT02305836|"~     A prospective block randomized controlled trial aimed at assessing if EA is more effective~     than donepezil for improving the cognitive function of AD patients. The hypothesis of this~     study is as follow:~        -  Is the short-term effect of electroacupuncture better than donepezil on improving~          cognitive function of patients with Alzheimer's disease after 12 weeks' treatment?~        -  Whether the effect of electroacupuncture on improving cognitive function can last until~          the end of 6 months' follow-up?~   "
57458|NCT02305030|"~     Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a~     washout period of at least 14 days.~   "
57459|NCT02305017|"~     Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods~     separated by a washout period of 14 days or more.~   "
57397|NCT02305823|"~     The selection of antipsychotic in early stages of the illness is mainly determined by its~     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug~     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a~     homogeneous group and clinical effects and profile of side effects differ between SGAs.~     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of~     increasing research interest, although comparisons between the different SGAs are scarce. In~     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to~     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less~     evident seems to be the notion that some of the SGAs might be more effective (in terms of~     treatment discontinuation) than others. Most of the medium-term randomized studies have~     shown similar rates of all-cause treatment discontinuation in first episode patients treated~     with different SGAs. It may be concluded that more randomized controlled trails should be~     accomplished to determine the position of frequently used SGAs in clinical practice. The~     investigators undertook this study with the major objective of comparing the clinical~     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in~     the acute treatment of first-episode non-affective psychosis individuals.~   "
57398|NCT02305810|"~     Everolimus represents an approved therapy for patients with advanced well/moderately~     differentiated pancreatic NETs. Although some patients could benefit from this drug in terms~     of long-term tumor growth control, others are resistant upfront or become resistant during~     treatment. Therefore, it is crucial to detect some biological factors which can help to~     identify the responsive tumors. Given that Everolimus is a biological agent and its~     mechanism of action can be partially directed towards angiogenesis its effects can be~     studied on different levels and with different methods. Upfront and early surrogate~     predictive markers of activity/efficacy can be studied on tumor tissue, tumor imaging, and~     peripheral blood. mTOR pathways alterations, circulating endothelial cells, and other~     circulating angoigenic factors will be correlated with clinical outcome. Tumor perfusion and~     circulating markers will be studied also as markers of response compared with the~     morphological imaging.~   "
57399|NCT02305797|"~     To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients~     with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.~     (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0).~     Efficacy will be measured by a statistically significant greater mean reduction from~     baseline compared to endpoint in anxiety symptoms as measured by the total score of the~     clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group~     compared to placebo.~   "
57400|NCT02305784|"~     YKL-40 is proposed as a biomarker of various inflammatory disease diabetes and lung disease~     including cystic fibrosis. In those cross-sectional studies, a unique value of YKL-40 is~     used to correlate with clinical, physiological, or biological determinants of disease~     severity (like FEV1 for example in lung disease). There is only one longitudinal study that~     showed a correlation between circulating levels of YKL-40 and the decline of lung function~     in smokers sampled from the general population. In order to better understand the potential~     role of YKL-40 in CF pathophysiology, and to determine its potential role as a biomarker of~     disease evolution, it is essential to proceed with further clinical evaluation. The~     investigators propose to perform an observational prospective cohort study to determine if~     variation of YKL-40 concentration over 24 months correlates with the clinical evolution of~     the patients.~   "
57401|NCT02305771|"~     The aim of the study is to demonstrate that our semantic knowledge (elements of our~     long-term memory and the process we use them) respond to a graphic organisation and gather~     together following accurate patterns called cliques (neural networks).~   "
57402|NCT02305758|"~     This study seeks to evaluate the efficacy and tolerability of veliparib in combination with~     FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or~     rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.~      This is a blinded study such that the Investigator and Subject will be blinded but AbbVie~     will be unblinded.~   "
57403|NCT02305745|"~     Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with~     preeclampsia in pregnancy.~   "
57404|NCT02305732|"~     The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is~     to address current gaps in platelet transfusion safety in selected geographic regions. The~     objective is to provide access to INTERCEPT PCs for patients who might be at risk of~     transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus~     (DENV) in regions in which a substantial proportion of the population has been infected or~     is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic~     infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).~      The study is designed as a prospective, open label, multi-center, observational study to~     evaluate the safety and efficacy of INTERCEPT platelet components.~   "
57405|NCT02305719|"~     Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic~     surgery to evaluate their efficiency in (postoperative) pain control.~      Three regional anesthesia forms are evaluated: thoracic epidural anesthesia,~     (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local~     anesthetic at the site of performing the thoracoscopy.~   "
57406|NCT02305706|"~     Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients~     positioned in the left lateral position. However, few published studies have explored~     alternatives and there is consequently little evidence to support left lateral starting~     position over alternatives.~   "
57407|NCT02305693|"~     140 women with clomiphene resistant PCOS will be randomly divided into 2 equal groups using~     computer generated random numbers. Group 1 will receive Letrozole, group 2 will have~     laparoscopic ovarian drilling (LOD).~   "
57408|NCT02305680|"~     This study is to describe the long-term antithrombotic management patterns in a real-life~     setting for patients hospitalized with an acute coronary syndrome in China.~   "
57488|NCT02304640|"~     There is a paucity of studies that focus on the symptom burden of cancer patients in~     Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that~     early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical~     and biological determinants of lingering symptoms in breast cancer survivors so that~     appropriate psychosocial interventions can be formulated.~   "
57409|NCT02305667|"~     Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL)~     provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We~     hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time~     for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing~     thoracic procedures.~      Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures~     using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35~     per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis~     view, ease of intubation, number of optimization maneuvers, and failure to intubation (>150~     s.) will be recorded.~   "
57410|NCT02305654|"~     This is an international phase III trial, with a Bayesian design, incorporating two~     sequential randomisations. It efficiently examines a series of questions that routinely~     arise in the sequencing of treatment. The study design has evolved from lengthy~     international consultation that has enabled us to build consensus over which questions arise~     from current knowledge and practice. It will enable potential randomisation for the majority~     of patients with inguinal lymph node metastases and will provide data to inform future~     clinical decisions.~      InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological~     criteria. Treatment options are then defined according to the disease burden strata.~     Treatment is allocated by randomisation. Patients may be allocated to one of three initial~     treatments:~      A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND);~     or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).~      After ILND, patients are defined as being at low or high risk of recurrence based on~     histological interpretation of the ILND specimen. Patients at high risk of relapse are~     eligible for InPACT-pelvis, where they are randomised to either:~      P. prophylactic PLND Q. no prophylactic PLND~   "
57411|NCT02305641|"~     This is a phase IV, prospective, multicenter, non-interventional study (regulatory~     post-marketing surveillance) in approximately 3,000 patients who are to receive Kadcyla~     (trastuzumab emtansine). Patients with HER2-positive, unresectable locally advanced or~     metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane,~     and administered Kadcyla infusion at physician's discretion will be registered for this~     surveillance in Korea. Patients will be asked to provide informed consent; data will be~     collected by electronic Case Report Forms for approximately 6 years.~   "
57412|NCT02305628|"~     This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing~     surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab,~     subcutaneous administration) per approved local labeling. Patients will be under observation~     according to standard of care in Korea.~   "
57413|NCT02305615|"~     This prospective, multi-center, observational study will investigate the effectiveness and~     safety of Avastin (bevacizumab) in routine clinical practice in patients with metastatic~     colorectal cancer. Patients are to have initiated first-line treatment with~     fluoropyrimidine-based doublet chemotherapy plus Avastin according to the Avastin Summary of~     Product Characteristics (SmPC). Target patient enrollment is 300 in Hungary.~   "
57414|NCT02305602|"~     This Phase I, open label, study will investigate the effects of VentriGel injection in~     patients who have experienced a first, large ST elevation myocardial infarction (STEMI)~     treated by PCI within the past 3 years and have evidence of left ventricular remodeling.~   "
57415|NCT02305589|"~     This study evaluated the effect of sugammadex on postoperative delirium in elderly patients~     undergoing hip fracture surgery.~      Medical records from 235 consecutive patients undergoing hip fracture surgery were~     retrospectively reviewed and total 61 patients were excluded for age under 60 years,~     preoperative neurologic problem. Finally total 174 patients aged over 60 years undergoing~     hip fracture surgery with general anaesthesia using a neuromuscular blocking agent from 2012~     to 2014 at a university hospital were analyzed to compare perioperative incidence of~     postoperative delirium, pulmonary complications, intensive care unit (ICU) admission, and~     ICU and hospital stay duration and laboratory findings between patients treated with~     sugammadex (S group) and conventional cholinesterase inhibitors (C group).~   "
57416|NCT02305576|"~     The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate~     Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic~     tone. The ANI is proposed as surrogate marker for the analgesia nociception balance.~     However, many perioperative factors such as medications, position, maneuvers may influence~     the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide~     opioid dosing has never been tested. Therefore, the aim of our study is to collect in a~     database all the perioperative factors and to study their influence on the ANI.~   "
57417|NCT02305563|"~     The purpose of this study is to determine the safety and effectiveness of ulocuplumab in~     combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid~     Leukemia (AML).~   "
57418|NCT02305550|"~     Study Design: This is a two-part physiological for a device feasibility. Both studies are~     proof of concept descriptive pilot studies.~      The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with~     pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).~      Volunteers and patients will be enrolled sequentially; there is no group randomization.~      Overall hypothesis of this device feasibility study: To test a lightweight and portable~     method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical~     pulsed discharge.~   "
57419|NCT02305537|"~     The collection of patient self-report and diagnostic data will allow us to examine the~     efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data~     gathered through routine clinical care, the investigators seek to explore whether patients~     in treatment show improvements from admission to discharge, compared to patients on the~     waitlist, and whether these gains are maintained three months post-discharge. The following~     are included as examples of some of the study's hypotheses.~   "
57420|NCT02305524|"~     The objective of this study is to compared effectiveness of intubation using ETView~     VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.~   "
57421|NCT02305511|"~     The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO~     intraosseous devices to standard peripheral venous catheterization during pediatric~     resuscitation.~   "
57422|NCT02305498|"~     Previous research suggests that regular physical activity may make cancer survivors do~     better in the long run. Laboratory studies suggest that stress may be bad for cancer~     patients as well. The investigators are interested in whether yoga, a practice that combines~     physical activity and stress reduction, is beneficial to cancer survivors. To answer that~     question, the investigators will need to do a large scale clinical trial.~      Before the investigators can do that large study, they need to know whether people are~     willing to participate in this kind of study, whether they can do the yoga practice~     regularly and for how long, what kind of changes they may experience in how they can handle~     their daily activities, emotion, sleep, memory and problem solving ability, and what are the~     changes that can happen in their body after doing the yoga practice. Answering these~     questions is what this study is about.~   "
57423|NCT02305485|"~     The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective,~     multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable~     coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to~     evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo~     coronary lesion.~   "
57424|NCT02305472|"~     The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center,~     single arm registry trial based on the NeoVas FIM study which verified the safety and~     effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of~     NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with~     de novo coronary lesion.~   "
57425|NCT02305459|"~     The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of~     selective internal radiation therapy (SIRT) for the treatment of patients with primary and~     secondary liver tumours. The CIRT Registry has two major objectives: 1) To collect robust~     data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres~     in a pan-European context, and 2) to collect data on the Quality of Life of patients treated~     with SIR-Spheres microspheres.~   "
57426|NCT02305446|"~     The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to~     collect blood donation. Sera panel obtained from blood donations will be used as a control~     to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.~   "
57427|NCT02305433|"~     Our objective is to study the effects of 12 months' intensive home-based physiotherapy with~     12 months' follow-up in two groups of older people (65+ y): 1) those with an operated hip~     fracture, and 2) those with signs of frailty. The primary outcome measure is duration of~     living at home. Power calculations are based on the assumption that persons assigned to~     physiotherapy will live at home for six months longer vs. those in usual care. Secondary~     outcomes are physical functioning, falls, health-related quality-of-life, use and costs of~     social and health services, and mortality.~      We will recruit 300 persons with hip fracture and 300 with signs of frailty in Eksote (South~     Karelia Social and Health Care District), Finland (population 133 000). The groups will be~     randomized separately into an intervention arm (home-based physiotherapy twice a week for 12~     months) and a control arm (usual care), resulting in 150 patients in each group.~      An assessor-physiotherapist performs measurements at the participant's home at baseline, and~     after 3, 6 and 12 months. Assessments include, among others, Fried's frailty criteria, Short~     Physical Performance Battery (SPPB), Functional Independence Measure (FIM), Health-related~     quality-of-life (HRQoL, 15-D), Mini Nutritional Assessment (MNA), Falls Efficacy Scale -~     International (FES-I), Social Provision Scale (SPS), Mini Mental State Examination (MMSE),~     and Geriatric Depression Scale-15 (GDS-15). At 24 months we collect register information on~     mortality and the usage of health care services.~      Recruitment will begin in December 2014 and last for three years. Data analyses and~     reporting will take place in 2017-20. The study is supported by the Social Insurance~     Institution of Finland.~   "
57428|NCT02305420|"~     EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage~     Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to~     this difficult group of patients.~      Results showed a highly significant effect of 44% relative improvement in ongoing~     implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).~      We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media~     improves pregnancy outcomes in women with recurrent implantation failure, recurrent~     miscarriage and poor embryo development when compared to standard media.~   "
57429|NCT02305407|"~     Adult patients with moyamoya disease (MMD) are reported to suffer from considerable~     impairment of executive function/attention. Although reduced cerebrovascular reserve (CVR)~     in frontal areas has been detected by perfusion MRI and then confirmed to be associated with~     executive dysfunction in adult MMD, the structural and functional changes is still unclear~     with progression of executive dysfunction. Furthermore, it is very important to study the~     association between the neurocognitive and radiological improvement after surgical~     revascularization, so as to help detecting cerebral regions which are involved in executive~     deterioration or improvement after surgery. Then the investigators can determine whether~     these regions can be used as indicators to decide rational therapeutic schedule and timing~     of adult MMD with executive dysfunction.~      Thus the aim of this study is to primarily find out the neuropsychological and radiological~     correlates in adult MMD, and then to quantitatively evaluate the effectiveness of surgical~     revascularization in prevention of executive dysfunction in adult MMD.~   "
57430|NCT02305394|"~     Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the~     current antidepressant agents，but the most important side effect is cognitive dysfunction.~     The purpose of this study is to determine whether subanesthetic dose of ketamine combined~     with propofol is superior to propofol anesthesia alone in improving cognitive function in~     depressive patients undergoing ECT.~   "
57431|NCT02305381|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as~     add-on to basal insulin alone or basal insulin in combination with metformin in subjects~     with type 2 diabetes.~   "
57489|NCT02304627|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food~     on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in~     a tablet formulation in healthy subjects.~   "
57432|NCT02305368|"~     In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases~     (lung and liver metastases), treatment with chemotherapy is necessary but not end in success~     in 10% of cases. The development of techniques for administering personalized treatment~     becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these~     patients and evaluating the effect of chemotherapy on these could be made for each patient.~     In France, the company develops Oncomedics these tests.~      This is a pilot study that will make a first evaluation under actual conditions of~     chimio-oncogramme.~   "
57433|NCT02305355|"~     Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in~     subjects with type 2 Diabetes combined with hyperlipidemia~   "
57434|NCT02305342|"~     This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with~     community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary~     objective is to study the spectrum of uropathogens responsible for community acquired UTI in~     local population~   "
57435|NCT02305329|"~     Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study~     consisted of two consecutive single-dose treatment periods separated by a washout period of~     10 to 14 days or more.~   "
57436|NCT02305316|"~     Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The~     study consisted of two consecutive single-dose treatment periods separated by a washout~     period of 14 days or more.~   "
57437|NCT02305303|"~     Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care~     may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life.~     Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to~     assess if diaries may improve quality of life after a severe trauma.~   "
57438|NCT02305290|"~     The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER)~     of superficial lesions of the Upper Gastrointestinal Tract(UGIT)~   "
57439|NCT02305277|"~     Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy~     volunteers. In each part, the study consisted of two consecutive single-dose treatment~     periods separated by a washout period of at least 14 days.~   "
57440|NCT02305264|"~     In this study we plan to image the compartmentalized inflammation in MS using molecular~     imaging by positron emission tomography (PET) with a very highly resolutive camera. Two~     tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral~     benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This~     new ligand for PBR displays several advantages compared to the existing reference compound~     PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility~     with [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose~     metabolism in activated immune cells in the white matter. Progressive MS patients (secondary~     progressive and primary progressive) will be compared to relapsing-remitting patients and to~     healthy volunteers. All subjects will pass a complete neurological evaluation and a~     multimodal MRI to document clinical disability and tissue injury. A clinical and~     radiological follow up will then be performed for a 2-year period. This study should help to~     understand the contribution of the intracerebral inflammation on the progression of~     disability and could provide a surrogate marker for further therapeutic trials in chronic~     progressive MS.~   "
57441|NCT02305251|"~     The investigators conducted a study Resect and Discard Diminutive Polyps: a new paradigm~     (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors~     performing colonoscopy are accurate enough at predicting histology of small colorectal~     polyps, such that these small polyps could be resected and discarded (instead of being sent~     to pathology). One of the main advantages of this approach is significant cost savings by~     reducing pathology costs associated with screening and surveillance colonoscopy. A~     disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no~     data regarding patient preferences toward this approach. The investigators therefore~     designed a patient survey to determine the patient's view toward this approach.~   "
57442|NCT02305238|"~     To assess the efficacy of intravitreal (IVT) administration of aflibercept with two~     different approaches of Treat and Extend dosing regimens in Japanese subjects with~     neovascular (wet) Age-related Macular Degeneration (wAMD) .~      To assess the safety of IVT administration of aflibercept with two different approaches of~     Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.~   "
57443|NCT02305225|"~     The investigators examine changes in decision making, vigilance and cortical excitability in~     healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand,~     and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night)~     on the other hand, in a cross over controlled manner. The investigators hypothesize that~     total sleep deprivation, as well as partial sleep restriction lead to impairments in~     decision making and vigilance, and enhanced cortical excitability.~      Beside these three primary outcomes, the investigators also assess changes in sleep by EEG,~     dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory,~     and also collect saliva samples.~   "
57444|NCT02305212|"~     This study will examine a cognitive rehabilitation protocol targeted at working memory~     deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized~     clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to~     improve working memory, will be examined in children with TBI. Neuropsychological and daily~     life functioning will be measured. Participants will be children (N=20) and adults (N=20)~     with a documented history of TBI. Participants will be randomized to a treatment group or a~     wait list control group. The Experimental Group will receive the Cogmed working memory~     training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time~     of approximately 15 hours. The Control Group will be a wait list control group that will~     cross over into treatment after the follow-up assessment. All subjects will undergo repeat~     assessments following completion of the working memory training protocol after the 7th week~     and again at 13 weeks to document changes in working memory performance.~   "
57445|NCT02305199|"~     The purpose of this study is to determine whether perioperative use of Hartmann's solution~     in type II diabetes patients increases blood glucose level after surgery. The investigators~     expect the result to broaden the choice of fluid for diabetic patients and hopefully to~     diminish the side effects manifested by the excess use of normal saline.~   "
57446|NCT02305186|"~     The purpose of this clinical trial is to study an experimental drug called pembrolizumab or~     MK-3475 for use in combination with chemotherapy and radiation therapy for patients with~     resectable (surgical removal) or borderline resectable pancreatic cancer. In general,~     pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy~     and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery~     might be possible. However, this is not always effective at shrinking the tumor enough to~     allow it to be removed with surgery. Recent discoveries suggest that the investigators own~     immune system might have a role in controlling the growth of tumors. Drugs such as~     pembrolizumab can stimulate the immune system against cancer. The purpose of this study is~     to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can~     improve the body's immune response against pancreatic cancer.~      Pembrolizumab has been approved for treatment of patients with melanoma but has not been~     proven to be safe or helpful in patients with pancreatic cancer and is not approved by the~     U.S. Food and Drug Administration (FDA) for this purpose.~   "
57447|NCT02305173|"~     Preoperative dexamethasone reduces symptoms after different surgical procedures including~     mastectomy in breast cancer, but the effect in the postoperative respiratory function~     remains unknown. The aim of this protocol was to determine if the administration of a single~     dose of dexamethasone during the preoperative, could improve respiratory function and~     postoperative symptoms of patients undergoing mastectomy in breast cancer.~   "
57448|NCT02305160|"~     The purpose of this study is to determine the efficacy and safety of the new pulmonary~     surfactant produced by Butantan Institute among premature infants with gestational age below~     34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.~   "
57449|NCT02305147|"~     Observational, prospective, monocentric study to assess clinical features, imaging and~     biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to~     healthy controls (HC) and subjects at risk to develop PD.~      The primary objective of this study is to identify clinical, imaging and biologic markers of~     PD onset and progression for use in clinical trials of disease-modifying therapies.~   "
57450|NCT02305134|"~     Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a~     nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults~     has already been established. It is reported that tipepidine inhibits G-protein-coupled~     inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by~     tipepidine is expected to modulate the level of monoamines in the brain. We put forward the~     hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD)~     symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK~     channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether~     treatment with tipepidine can improve symptoms in pediatric patients with ADHD.~   "
57451|NCT02305121|"~     The aim of this project is the prospective data collection of a new device used for~     trochanteric fractures of the femur. It should be answered how the newly developed implant~     called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing~     clinically and radiological in terms of intra- and postoperative complications.~   "
57452|NCT02305108|"~     The study will test the efficacy of the treatment of soft tissues for osteoarthritis~     patients that are waiting for total hip arthroplasty. The fascial manipulation provides a~     deep pressure of specific points of the muscle fascia. The aims of this treatment are the~     improve of pain before the surgery and the improve of functional performance after the~     surgery.~   "
57453|NCT02305095|"~     The response to therapy with a fixed dose combination of isosorbide dinitrate and~     hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced~     ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to~     confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism~     of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10,~     influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC~     I/H in 500 self designated African American subjects with systolic heart failure. They will~     be followed for up to two years on therapy. Clinical outcomes (survival, heart failure~     hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3~     genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele~     (those with the GNB3 TT genotype which is present in approximately 50% of black subjects)~     demonstrate enhanced therapeutic benefit from FDC I/H.~   "
57454|NCT02305082|"~     The implementation of an enhanced recovery pathway after giant ventral hernia repair,~     including preoperative high-dose steroid is examined prospectively and compared with a group~     of historic controls.~   "
57455|NCT02305069|"~     Obesity in humans has been shown to result in the increased release of small~     inflammatory-inducing proteins, called cytokines, from the fat cells of the body. The~     investigators are interested in the effects of these cytokines on the mechanisms that~     control muscle mass and metabolism in the obese human. Previous research from work in cells~     and animals has shown the cytokines reduce the synthesis of muscle proteins and~     simultaneously enhance their rate of breakdown, resulting in a loss of muscle mass.~     Furthermore, research suggests that the same cytokines may inhibit carbohydrate oxidation, a~     pivotal step in muscle metabolism. However, despite these potential negative consequences~     for skeletal muscle function, the effect of low-level and persistent inflammation as seen in~     obese humans, remains largely unknown.~      In the current study, the investigators plan to measure the rates of synthesis and breakdown~     of muscle proteins in conjunction with rates of carbohydrate oxidation in obese older~     participants, and compare them to rates determined in healthy non-obese individuals.~     Furthermore, participants will undergo a 12-week course of either pioglitazone, an insulin~     sensitiser often prescribed to type II diabetics, or a placebo. Pioglitazone has been shown~     previously to normalise the levels of cytokines in the blood of chronically inflamed~     individuals. By repeating after the 12-week intervention period the initial measurements~     described above, and by accurately determining the levels of the cytokines, the~     identification of the negative effects of obesity-induced inflammation in older adults on~     muscle metabolism will be determined.~   "
57456|NCT02305056|"~     The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive~     isotopic tagging (carbon 13 and nitrogen 15).~   "
57457|NCT02305043|"~     The aim of this study is to identify biomarkers predicting response or resistance factors of~     a targeted therapy with trastuzumab in advanced gastric cancer.~   "
57460|NCT02305004|"~     To follow up the result of a quality measurement based on the results of a new routine for~     drug analysis introduced during a period of time in the intensive care unit. To ensure the~     quality of the dose regimen of routine drugs for sedation and analgesics. The aim is also to~     find out if the routine analysis can give information about if the self- intoxicated~     patients have taken drugs that were primarily not suspected.To know the serum concentrations~     of routine drugs in patients who died and will undergo autopsy.~   "
57461|NCT02304991|"~     Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in~     subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this~     objective will be a statistically significant difference in challenge scores between the~     treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food~     challenge) performed after 36 months of peanut SLIT (desensitization). A secondary outcome~     of this objective will be a statistically significant difference in the challenge score of~     the treatment group versus the placebo group during the DBPCFC performed 3 months after~     discontinuing therapy (tolerance). Challenge scores are measured by the amount of peanut~     protein participants are able to ingest successfully without symptoms of an allergic~     reaction. [Time Frame: Baseline, 39 months]~      Secondary Objective: To examine the change in immune parameters associated with peanut SLIT~     and the development of clinical tolerance. Through this objective, the investigators will~     seek to understand the molecular processes by which SLIT affects the immune system through~     evaluation of immune mechanisms in relationship to clinical findings of desensitization and~     tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent~     cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4~     response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick~     testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation.~     The investigators anticipate that the effect of peanut SLIT will occur by induction of~     TRegs, conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte~     response (measured by cytokines, antibody levels, and skin prick test size), a change in~     peanut-specific basophil activation, or through a combination of the above.~      [Time Frame: Baseline, 39 months]~   "
57462|NCT02304978|"~     Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and~     general ( presence of metastases , usually liver ). This is the most common cancer in France~     and, despite surgical treatment of the primary tumor, it is still subject to a high~     mortality rate due to metastatic evolution, mainly hepatic .~      There is currently no specific marker for predicting cancer, the same hardly changed , which~     would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring~     of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the~     coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness.~     Corroborating evidence that the way the TF plays an important role in the invasive and~     metastatic potential of CRC. First, various human cancer cell lines express the FT colic.~     Furthermore, there is a relationship between the importance of monocyte TF expression and~     the evolutionary potential of human CRC.~      The investigators hypothesize that these interest intra-platelet and plasma markers are a~     reflection of tumor angiogenic potential. And the investigators will verify the superiority~     of their preoperative levels in the CRC group compared with the control group, normalization~     of postoperative after surgical resection rates and their possible re-ascent in case of~     tumor recurrence in the CRC group.~      The levy to one month in controls allow us to verify the absence of secondary modification~     to laparotomy, the colectomy and general anesthesia.~      The investigators assume that the rate of soluble TF in peripheral blood of the holders of~     CRC patients may be a marker of invasion and aggression (i.e. prognosis).~   "
57463|NCT02304965|"~     Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to~     proof the feasibility of a specific individual training at home aimed to increase pulse~     pressure above a predefined threshold which might attenuate the loss of arterial wall~     thickness.~      Hypothesis:~      Increasing daily physical activity near to normal (> 10.000 steps per day) with a~     pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to~     investigate changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD~     patients.~   "
57464|NCT02304952|"~     The aim is to study the effects related to function and pain during eccentric exercise and~     surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with~     only eccentric exercise, in patients with lateral epicondylalgia unilaterally.~   "
57465|NCT02304939|"~     CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of~     three changeovers of norepinephrine used routinely in ICU. The three techniques are:~        -  Quick change~        -  Double pumping~        -  Smart infusion pumps~   "
57466|NCT02304926|"~     Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with~     statins and ezetimibe generally constituting the medication of choice. By acting at~     different levels, the combination of these drugs allows the therapeutic objective to be~     achieved. However, it is not known how these drugs qualitatively affect the composition of~     lipoprotein subfractions, which differ in size and atherogenic potential. The investigators~     set out to evaluate this effect as well as their effects on inflammatory, oxidative stress~     and endothelial function parameters.~   "
57467|NCT02304913|"~     This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison~     to sham acupuncture and standard medical treatment (dietary recommendations) in the~     treatment of dysgeusia in cancer patients undergoing chemotherapy.~   "
57468|NCT02304900|"~     The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens~     with a refractive implant. Two colors of implants are available: white implants, filtering~     out ultraviolet and yellow implants, filtering and more blue light. No clinical data are~     available to assert the superiority of an implant according to its color and the choice is~     made according to the preference of the surgeon and / or markets.~      It is established in humans that blue light has an important role on the secretion of~     melanopsin, a key mediator of the circadian cycle. This clock regulates most~     neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The~     question of the impact of these neuro endocrine functions of the installation of a blue~     light filter into the eyes of patients operated thus arises.~   "
57469|NCT02304887|"~     The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we~     plan to reveal relationship between osteoporosis drugs and kidney damage.~   "
57470|NCT02304874|"~     Normal body iron store value in overweight subjects is currently not described in~     literature. The comparison of this value with body iron levels in patients suffering from~     dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this~     condition. The purpose of the study is to determine iron levels in healthy overweight~     volunteers, and to compare them to DIOS patients treated with phlebotomy.~   "
57698|NCT02301910|"~     The aim of the study is to determine if single-bolus recombinant nonimmunogenic~     staphylokinase is effective and save thrombolytic agent in patients presenting ST-segment~     elevation myocardial infarction in comparison to tenecteplase.~   "
57471|NCT02304861|"~     Objective of this study is the comparative assessment of the beneficial impact of the~     Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema~     following torsional-ip cataract extraction surgery.~      Participants will be recruited from the Cataract Service of the University Hospital of~     Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include~     diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens~     Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer~     randomization program all participants will randomly populate two study groups according to~     the OVD used (ie. viscoat or visthesia).~   "
57472|NCT02304848|"~     The purpose of this study is to evaluate the effects of low frequency deep brain stimulation~     on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the~     cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech.~     This study will provide insight into what the effects of low frequency stimulation are on~     neural synchrony.~   "
57473|NCT02304835|"~     This study was a national, longitudinal, prospective, observational survey, carried out in~     metropolitan France, with a sampling of 21 birth control centres.~      The aim of this study was to assess, in real life conditions, the benefit of a urinary~     semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing~     the concordance between qualitative results from the urinary test and quantitative values~     from the beta-hCG blood measurement.~   "
57474|NCT02304822|"~     The purpose of this study is to compare the postoperative systemic inflammatory response~     syndrome (SIRS) rates undergoing retrograde intrarenal surgery (RIRS) after multiple-,~     single-, zero-dose of ceftriaxone prophylaxis in a prospective randomized trail.~      The investigators will enroll 300 patients who are candidates for RIRS in the investigators~     study. By simple random sampling technique, patients will be assigned to three 100-patient~     groups (multiple-, single-, zero-dose of ceftriaxone prophylaxis,respectively). In addition~     to the difference of usage of ciprofloxacin prophylaxis, the rest of the procedure is the~     same in all three groups.The end point of the study is the comparison of outcome of~     procedure including SIRS rate, stone free rate (SFR), operation time, length of stay,and~     hematuresis.~   "
57475|NCT02304809|"~     Patients with metastatic or unresectable locally advanced malignancies harboring BRAF~     genomic alterations, the biological target of vemurafenib, and who are no more amenable to~     curative treatment.~      To explore the efficacy of vemurafenib as a single agent across diverse type of tumors~     guided by the presence of identified activating molecular alterations in the vemurafenib~     target gene, per cohort.~   "
57476|NCT02304796|"~     The current pilot study will examine and compare the effectiveness of two group~     psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol,~     adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.~      In addition, change in proposed mechanism in each therapy will be examined, along with their~     association with change in outcome measures during therapy.~   "
57477|NCT02304783|"~     Outpatients treatment with NSAI in renal colics has not been well investigated and there is~     no clear recommendations regarding this matter.~      The aim of this study is to determine if an oral NSAI treatment is beneficial in patients~     discharged for the emergency departement after the first line treatment of a renal colic~     investigating the recurrence of pain, the reconsultation rates and the admissions.~   "
57478|NCT02304770|"~     The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT)~     of cervical precancerous lesions in women.~   "
57479|NCT02304757|"~     Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of~     levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of~     osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,~     calcium containing vitamin D alone and fosamax (alendronate sodium) in postmenopausal women~     with DTC and decreased bone mineral density (BMD).~   "
57480|NCT02304744|"~     UCORBIO enrolls patients who undergo coronary angiography (for any indication). The~     investigators draw blood at the moment of insertion of the procedural arterial catheter.~      At the moment of inclusion indication, procedural details, risk factor status, medication~     use and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for~     the occurrence of major adverse cardiovascular events for 5 years. During the follow-up~     period patients receive a questionnaire every year to check for hospital admissions. The~     questionnaires at two and five years of follow-up are enriched with quality of life~     questionnaires (RAND-36 and EuroQoL).~   "
57481|NCT02304731|"~     Modern society increasingly seeks healthy life style, and regular physical activity is~     considered one of the main factors that improve the quality of life. The evidence shows that~     the aerobic physical training in controlled environments benefit various aspects of human~     health, including cognition in the elderly population. However, when exercise is performed~     in a polluted environment, the individual is subjected to grater exposure to pollutants due~     to increased ventilation (breathing).~   "
57482|NCT02304718|"~     This study evaluates the role of exercise intervention in reducing the risk of gestational~     diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m^2） Chinese pregnant~     women. Half of participants will have exercise intervention, while the other half will not.~     Both of the two group will have regular prenatal care.~   "
57483|NCT02304705|"~     The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is~     effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a~     double-blind, placebo controlled trial.~   "
57484|NCT02304692|"~     This study is designed to compare two different surfaces of bone anchored hearing aid~     abutments in terms of bacterial colonization, inflammatory response and skin reactions.~   "
57485|NCT02304679|"~     The primary objective of this study is to evaluate the change from baseline in the erectile~     function domain of the International Index of Erectile Function (IIEF-EF) scores in patients~     receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment.~     The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.~   "
57486|NCT02304666|"~     Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's~     precise origin is unknown until now. Today, the current hypothesis of the disease~     pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut~     microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on~     interactions between immune and epithelial cells. Epithelial cells are the first line of~     defense, are tightly connected to the underlying gut associated lymphoid tissue and their~     alteration results in loss of tissue homeostasis.~      Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell~     response to stress.~      This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to~     tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more~     resistant to experimental colitis and administration of cystamine (oxidized form of~     cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1~     expression in IBD patients show that high VNN1 expression is associated with severe clinical~     features. Thus, analysis of VNN1 expression could represent a good prognostic marker.~      In a recent published article, we characterized among a retrospective cohort of 500 IBD~     patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and~     showed their association with IBD incidence and high VNN1 expression. This suggested that~     the VNN1gene might be a new predisposition marker of IBD.~      In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg~     transcription factors. Interestingly, one of the SNPs identified in patients participates to~     a PPARg binding site. Interestingly, drugs related to the family of 5-ASA which are commonly~     used in IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in~     patients under 5-ASA therapy might help predicting response to therapy and select patients~     with the highest benefit for this therapy.~      The purpose of this new project is to extend our initial analysis. The study will be~     prospective, monocentric and controlled. Its primary objective is to evaluate the level of~     VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm~     the correlation between high VNN1 expression and IBD. In relation with its prospective~     nature, we will also try to associate VNN1 expression level with specific endophenotypes~     (severity and/or localization of the lesions, quality of the response to therapy). Finally,~     we will screen patients for the previously identified SNPs to integrate this information in~     the interpretation of the results of expression analysis.~      This study is planned on 2 years. Two groups of patients will be constituted: one group will~     include IBD patients followed in the  Service de Gastro-entérologie du Pr Grimaud à~     l'Hôpital Nord  and the other group will constitute the control cohort including persons~     who were proposed a screening colonoscopy for familial history of colon cancer or polyps, or~     for Irritable Bowel Syndrome.~      The investigator will have to fill a questionnaire for each included patient, collecting~     information about age, sex, past medical history, taken medicine, digestive symptoms and~     colonoscopy indication.~      IBD patients will have a first set of biopsies (n = 10) and blood samples collected under~     general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set~     of similar samples will be collected within the next 12 months if an endoscopic control is~     medically justified. The control subjects will have only one set of biopsy and blood samples~     collected under general anesthesia during their colonoscopy. In the particular case of IBD~     patients who require surgery, a small piece of the resection will be collected ex-vivo on~     both healthy and pathologic areas.~      The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and~     SNP's genetic study.~      The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one~     for histopathological analysis and the other for transcriptional analysis by qRT-PCR.~      The surgical samples will be used for transcriptional activity, tissue pantheteinase~     activity and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry.~      Expected benefits are to validate a new IBD prognostic marker for disease severity or~     potentially for evaluation of the therapeutic response.~   "
57487|NCT02304653|"~     Aim: To investigate if the results of CRP and leucocytes had any positive or negative~     influence on the surgeon's decision-making when handling patients with suspected AA.~   "
57490|NCT02304614|"~     3D surface imaging has been used in the objective evaluation of cosmetic outcome of~     oncoplastic procedures such as breast reconstruction and lipofilling, however there is only~     one article published relating to Breast Conserving Therapy (BCT).~      The aim of this study is to assess the use 3D surface imaging as a tool in the assessment of~     symmetry of outcome following breast conserving therapy. The results of the surface imaging~     will be correlated with patient satisfaction, using the BREAST-Q, which is a validated~     patient questionnaire and correlated with panel assessment by an independent panel of two~     surgeons, one clinical oncologist and one breast care nurse.~   "
57491|NCT02304601|"~     The primary objective of this research is the development and testing of a brief~     cross-indication instrument (screening) for use in the approval process of medical~     rehabilitation services. In addition to the empirical foundation, this generic instrument~     should have a high level of acceptance of both applicants and payers of rehabilitation~     services. Furthermore, an everyday and economic use for the routine application process for~     medical rehabilitation services at the German statutory pension insurance scheme should be~     provided. In the first study phase, a long instrument was tested with a sample of~     rehabilitees that received approval of medical rehabilitation services. This assessment~     including the measurement of rehabilitation-related somatic, psychological and social~     impairments was first tested for its psychometric properties and then reduced to a short~     instrument (screening) using quantitative methods. In the second study phase, the~     then-existing screening will be part of the application documents for medical rehabilitation~     services to assess its management properties and practicability in everyday use of the~     German statutory pension insurance scheme.~   "
57492|NCT02304588|"~     Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell~     transplantation into ischemic foot, make its differentiation to form new blood capillary,~     improve and restore the local blood flow.~   "
57493|NCT02304575|"~     Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age,~     with incidence rates rising in western countries including Israel. Cure rate of testicular~     cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL),~     coping, effects on couple relationships, cognitive function, cognitive orientation and~     hormonal function become increasingly important. This study aims to assess all these issues~     using validated, reproducible questionnaires and hormonal plasma levels, and compare them~     between testicular cancer survivors and controls.~   "
57494|NCT02304562|"~     Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem~     Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived~     Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.~   "
57495|NCT02304549|"~     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older~     than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar~     transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in~     frail patients, conventional TUR-P is associated with relevant and potentially deleterious~     complications, e.g. TUR syndrome. Using isotonic saline, like in bipolar TUR-P and~     transurethral laser vaporization (TUV-P), TUR syndrome can be prevented.~      The short-term complication rate with the Thulium laser is similar to the rate described~     after vaporisation with other laser systems18-23 and less than that with TUR-P.~      Despite recent publications on the safety and complications with Thulium vaporisation of the~     prostate, to the investigators knowledge, until now, no prospective trial has directly~     assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser~     vaporisation of the prostate.~      The investigators therefore aim to investigate if absorption of irrigation fluid occurs~     during Thulium Laser vaporisation of the prostate by expired breath ethanol test.~   "
57496|NCT02304536|"~     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using~     computer generated random numbers. Group 1 will receive combined metformin and FSH, group 2~     will have LOD and group 3 will act as the control group with no intervention.~   "
57497|NCT02304523|"~     The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613~     compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel~     cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.~   "
57498|NCT02304510|"~     The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in~     females aged between 18 and 50 years old living in Bejing.~   "
57499|NCT02304497|"~     Diabetic patients may show different release of growth factors when microvascular~     complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse~     effect on periodontal health and periodontal infection have an adverse effect on glycemic~     control and incidence of diabetes complications. Therefore, the investigators hypothesize~     that growth factors levels releasing from platelet rich fibrin (PRF) in diabetes mellitus~     (DM) may be decrease because of periodontitis is considered to be the sixth microvascular~     complication of diabetes or diabetes may have inductive effect on PRF growth factors levels~     in periodontal disease. Determination of PRF growth factors levels may be beneficial to~     treatment of diabetic patient with periodontal disease by using PRF.~   "
57500|NCT02304484|"~     To characterize the safety and tolerability of long-term administration of evolocumab in~     subjects with known coronary artery disease and hypercholesterolemia~   "
57511|NCT02304341|"~     Children are admitted in intermediate units when the severity requires continuous~     monitoring. In France, Resources allocated to intermediate units are determined from lists~     of diagnoses and associated acts to additional budget. A score to assess the severity of~     illness may be associated with acts to develop an activity indicator easy to use. The~     investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric~     Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In~     France, they have not been validated. The correlation between the severity of children and~     the associated diagnoses and acts has not been studied. The main objective of this study is~     to validate these 2 scores. The secondary objective is to determine a simplified activity~     indicator.~   "
57699|NCT02301897|"~     The primary objective of this study is to determine the safety and efficacy of two oral~     doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each~     separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine~     fibroids.~   "
57501|NCT02304471|"~     Cardiovascular disease is the major cause of morbidity and death in patients with chronic~     kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired~     renal function and increased risk for cardiovascular diseases, however, remain elusive.~      Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer~     than 200 nucleotides. While the roles of lncRNAs in human diseases including cancer and~     neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA~     regulation contributes to cardiovascular complications in patients with renal dysfunction.~      In this proposal, the investigators seek to apply next-generation sequencing technology to~     investigate circulating lncRNA expression in control subjects and in patients with CKD and~     ESRD. The investigators will test the hypothesis that circulating lncRNA expression~     signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A~     gene co-expression network analysis will be conducted to identify lncRNAs that are~     functionally involved in the pathogenesis of CKD and ESRD. Next, the investigators will~     identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD~     patients. Finally, the investigators propose to test the hypothesis that circulating lncRNAs~     can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function~     progression in CKD patients. The results from these experiments will lead to better~     understanding of how circulating lncRNAs contribute to uremic cardiovascular complications~     and renal function progression.~   "
57502|NCT02304458|"~     This phase I/II trial studies the side effects and best dose of nivolumab when given with or~     without ipilimumab to see how well they work in treating younger patients with solid tumors~     or sarcomas that have come back (recurrent) or do not respond to treatment (refractory).~     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different~     ways by targeting certain cells. It is not yet known whether nivolumab works better alone or~     with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.~   "
57503|NCT02304445|"~     This is a randomized, open-label, active comparator-controlled trial of subjects with~     advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one~     treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization.~     Subsequently, subjects will be randomized to observation or, if indicated, up to an~     additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response~     following interventions will be evaluated at three months.~   "
57504|NCT02304432|"~     The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an~     augmentation strategy in two psychotic patients with a triplication (4 copies) of the~     glycine decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm~     of treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled~     exposures to DCS or placebo. The length of each double-blind arm is limited to six weeks to~     minimize the length of symptom exacerbation experienced by the subjects when they are~     receiving placebo. The randomization scheme will allow two consecutive exposures to DCS, but~     will not allow two consecutive exposures to placebo, again to minimize the length of any~     symptom exacerbation. At the end of the open-label DCS trial, the following procedures will~     be carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory~     evoked potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours~     after a single oral dose of a DCS will be assessed. Baseline data on all of these measures~     were previously obtained as part of a different study registered in clinical trials.gov -~     NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well~     as plasma levels of large neutral and large and small neutral and excitatory amino acids and~     psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo~     will be compounded and dispensed by the McLean Hospital Pharmacy.~      The investigators hypothesize that mutation carriers will have reduced endogenous brain~     glycine and GABA levels and increased brain glutamate and glutamine levels. DCS~     administration will increase brain glycine in the two carriers compared to baseline and~     treatment with glycine (0.8g/kg).~      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs~     modulated by NMDA in mutation carriers compared with non-carrier family members and~     controls.~      . The investigators hypothesize that DCS, but not placebo, will improve positive, negative~     and affective symptoms as well as neurocognitive function.~      The investigators also hypothesize that DCS will improve clinical and cognitive functioning,~     will partially normalize decreased baseline glycine and GABA and increased glutamate and~     glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked~     potentials.~   "
57505|NCT02304419|"~     The main purpose of this study is to learn more about how the study drug called galunisertib~     affects the immune system in participants with cancer. The study treatment is expected to~     last about six months for each participant, not including screening or follow-up.~   "
57506|NCT02304406|"~     Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North~     Africa population by using the Ventana ALK-IHC method for ALK protein detection in~     retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement~     with clinical and pathological parameters of NSCLC patients in MENA.~   "
57507|NCT02304393|"~     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,~     pharmacodynamics and activity of RO7009789 administered in combination with MPDL3280A in~     patients with metastatic or locally advanced solid tumors. The study will be conducted in~     three parts (I, II, and III), with part I divided into parts IA and IB and into subcutaneous~     (s.c.) and intravenous (i.v.) treatment groups. All patients will be followed up for~     survival until death or loss of follow-up after the last visit or withdrawal of consent.~   "
57508|NCT02304380|"~     The proposed study uses a recent policy change in Ohio as a natural experiment to assess~     outcomes and experiences of children who qualify for Medicaid under the Aged, Blind,~     Disabled category and their caregivers in an ACO model of care compared to their previous~     outcomes and experiences in a traditional fee-for-service model.~   "
57509|NCT02304367|"~     UX023T-CL201 is an, open-label, Phase 2 study. The study will be conducted in adults aged 18~     years or older with TIO or ENS whose tumor/skin lesion is inoperable to assess the efficacy~     and safety of KRN23 administered via subcutaneous injections monthly (every 4 weeks) for a~     total of 144 weeks. Subjects will need to discontinue oral phosphate and vitamin D~     metabolite therapy prior to randomization and throughout the duration of the study.~   "
57510|NCT02304354|"~     Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in~     rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to~     previous studies, 25 to 50% of patients have an insufficient or absence of response to~     rituximab at week 24.~      In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first~     course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the~     baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of~     CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the~     involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective~     study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes,~     to monitor rituximab-treated RA patients.~   "
57512|NCT02304328|"~     All patients (≥18 years) with a spontaneous SAH proven by computed tomography (CT), magnetic~     resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon~     presentation to a neurosurgical centre the patients will be treated according to the local~     protocol. Upon admission the patient is clinically evaluated for occurrence of clinical~     signs of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing).~     Usually first line treatment includes neurological resuscitation (placement external~     cerebrospinal fluid drainage in case of hydrocephalus, treatment of seizure, and general~     intensive care measures). Hereafter, the patient is clinically evaluated for a second time.~     The patients will be graded according to the usual WFNS scale and the modified herniation~     WFNS scale. The whole treatment of the patient will be according to local clinical~     protocols. Outcome will be measured at six and twelve months by trained investigators who~     are unaware of clinical data. The primary endpoint is the difference of specificities of the~     WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage.~     Given that specificity and sensitivity are negatively correlated, difference in sensitivity~     will be the second primary outcome.~      The null hypothesis to be tested is that the ratio of the true negative rates (specificity)~     of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as~     truly negative (good outcome) as compared to the old score. In addition and because of the~     negative correlation between specificity and sensitivity we will also test that the ratio of~     the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than~     18% less patients as truly positive (poor outcome).~   "
57513|NCT02304315|"~     This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of~     hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study~     to determine its optional dose.~   "
57514|NCT02304302|"~     The purpose of this research study is to learn if the medication Memantine Hydrochloride~     (the study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto~     Costa and his research team want to see if a 16-week treatment with this medication can~     improve the participant's ability to learn and remember things. In this study, memantine~     hydrochloride will be used. Thus, the researchers want to learn whether the study drug can~     help improve memory in young adults with Down syndrome. To test the effect of the study~     medicine, half of the people in the study will receive the study medicine and half will~     receive a placebo (an inactive substance). Memantine is an approved medication to treat~     memory and thinking problems in persons with Alzheimer disease. However, little is known~     about the effect of this medication in persons with Down syndrome and it has not been~     approved for use in persons with Down syndrome.~   "
57515|NCT02304289|"~     The purpose of this study is to evaluate the Safety and Pharmacokinetics of Oral Artesunate~     in patients with advanced hepatocellular carcinoma (HCC)~   "
57516|NCT02304276|"~     This study will evaluate the two main types of replacement tissue heart valve used in~     current practice, comparing outcomes from surgical aortic valve replacement (AVR) with that~     of the more recently introduced key-hole procedure called transcatheter aortic valve~     implantation (TAVI). Participants will be recruited at various time points ranging from 1~     month to 10 years following valve replacement with either AVR or TAVI. It is thought that~     progressive calcium (chalk) formation is responsible for the failure of the majority of~     these valves. All participants will therefore have a PET-CT scan with a special type of~     tracer called 18F-fluoride in order to measure active calcium formation in the valve. They~     will then have annual clinical follow-up for 5 years and be invited back for a repeat CT~     scan at 2 years to measure change in calcium burden. This study aims to investigate,~     firstly, the effects of valve age and type on calcium formation as measured by PET-CT and,~     secondly, whether this measure of calcium formation can help to predict how long different~     types of valve will last. If successful, 18F-fluoride PET-CT could become a valuable tool~     for testing new treatments to improve valve longevity and new valve designs.~   "
57517|NCT02304263|"~     Tenofovir continues to play a vital role in the treatment of the human immunodeficiency~     virus (HIV) and as the age of the HIV-infected population increases in the United States and~     worldwide, there is an urgent need to understand the extent to which older age influences~     the way this antiretroviral medication works in the body. The investigators study aims to~     characterize and compare the pharmacology of tenofovir in older versus younger HIV-infected~     adults and to assess kidney function over the course of approximately one year. The~     investigators will be analyzing tenofovir levels in different compartments of the blood and~     in hair samples, and will be assessing the relationship between tenofovir concentrations and~     changes in kidney function over time in the older and younger cohorts. Lastly, the~     investigators will be evaluating the relationship between tenofovir concentrations and~     functional status (including body composition, bone mineral density, and frailty) in study~     participants.~   "
57518|NCT02304250|"~     Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3].~     Perioperative single-dose dexamethasone therapy has been used for several purposes: to~     reduce post-operative nausea and vomiting (PONV), pain and sore throat. There are also some~     reports on beneficial effects of less cardiac arrhythmia, improved appetite and less edema~     from glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent~     reversal laryngeal nerve injury and improve voice quality after thyroid surgery. While~     accepted wildly in clinical anesthesia practice, the immune-press related potential risks of~     side effects associated with dexamethasone, such as delayed wound healing, infection, as~     well as effects on blood sugar, make the use of perioperative single dose of glucocorticoid~     controversial. The effect of perioperative dexamethasone on wound healing varied with~     different types of surgery. The present study will observe the effect of dexamethasone on~     the safety of thyroid surgery.~   "
57519|NCT02304237|"~     This study is for compare the efficacy of two different regimens(vaginal vs intramuscular)~     of progesterone therapy in prevention of preterm birth in high risk pregnant women.~   "
57520|NCT02304224|"~     The aim of the study is to investigate the relationship of nocturnal use of eye masks and~     immune function, cerebral function and outcomes of patients with sepsis. Thus more efficient~     and comprehensive treatment could be provided for patients in the duration of admission in~     intensive care unit.~   "
57521|NCT02304211|"~     The purpose of this protocol is to demonstrate that intra-arterial administration of a drug~     can generate information in a manner that faithfully mimics effects of systemic~     administration but with little or no systemic effects.~   "
57525|NCT02304159|"~     This is a randomized, open label, single center safety and efficacy study. At least 40~     cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir~     and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product).~     Subjects will be randomized in a 1:1 to receive either:~        -  Group A: 16 weeks of DCV/SOF/RBV~        -  Group B: 24 weeks of DCV/SOF/RBV~      Subjects will return to the study center at various time points throughout the 16 or 24~     weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor~     safety and efficacy. These visits will be according to standard of care.~   "
57526|NCT02304146|"~     The aim of this study is to investigate the long-term follow-up of the previously conducted~     FOAM study.~   "
57527|NCT02304133|"~     This study explores the effect of a four-hour ultrasound course on physicians' point-of-care~     ultrasound performance on patients representing acute abdominal surgical conditions.~   "
57528|NCT02304120|"~     This study evaluates the effects of additional sensorimotor training (proprioceptive~     postural training, PPT) to conventional therapy in the treatment of chronic low-back pain.~     Half of the participants will receive instructed treadmill training as an active comparator~     against PPT. All participants receive conventional physiotherapy as prescribed by their~     treating medical doctors. It is expected that the PPT group will improve in postural~     control, proprioceptive, as well as pain and function outcomes to a significantly greater~     extent than the active control group.~   "
57529|NCT02304107|"~     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using~     computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and~     group 3 will act as the control group with no intervention.~   "
57530|NCT02304094|"~     The aim of this study is to establish which of two treatment options is the preferred~     intervention in the treatment of Morton's Neuroma.~      A randomised controlled trial shall be performed. Steroid injection is the current gold~     standard conservative treatment for this condition. Therefore, manipulation shall be~     compared to a control group receiving a steroid injection in an equality randomised~     controlled trial.~      Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford~     Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of~     life questionnaire and algometric pressure threshold testing. An improvement in either~     groups' VAS of 20mm above the other group shall be considered as the minimum worthwhile~     change as this has been identified as the minimum clinically important difference in pain~     between treatment groups in visual analogue pain scales.~      There is limited research evidence to support the management of Morton's neuroma with~     steroid injection although its efficacy has only been demonstrated in the short term.~   "
57531|NCT02304081|"~     The purpose of this study is to evaluate alpha- and beta-cell function during combination~     treatment with saxagliptin in addition to dapagliflozin and metformin compared to placebo in~     addition to dapagliflozin and metformin in subjects with T2DM on stable metformin background~     therapy.~   "
57532|NCT02304068|"~     Currently the best treatment for wet macular degeneration involves regular injections of~     Ranibizumab (Lucentis). In the initial clinical trials, the drug was injected into the eye~     every month. Since then a number of studies have found similar benefits when the drug is~     given with a fixed number of injections initially and then with further injections only when~     needed. This approach has been adopted in the UK, following recommendation by the National~     Institute for Clinical Excellence (NICE).~      Although this approach reduces the expense and risk of un-necessary treatment, it does~     require regular hospital assessment of disease activity to determine if a repeat injection~     is required or can be deferred. The hospital assessment is time-consuming, inconvenient and~     the large number of assessments can cause delays in hospital follow-up.~      Using three different assessment criteria to monitor disease activity at home, the~     investigators plan to see if home monitoring is as good as hospital assessment. The~     investigators have already identified that many patients dislike the lengthy hospital~     assessment visit and would welcome the opportunity to do some of the monitoring of disease~     activity at home. The investigators have also shown that they understand and can complete~     each of the home assessment tests. In this pilot project, the investigators aim to get an~     idea of how reliable home monitoring can be in a small sample of just over 30 patients. The~     data that the pilot project generates will be used to influence and to help plan a~     subsequent, larger, national study to be submitted for funding to the National Institute for~     Health Research.~   "
57533|NCT02304055|"~     200 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).~   "
57534|NCT02304042|"~     250 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in~     10ml saline and will be given by the slowly intravenously after delivery of the anterior~     shoulder. The investigators will not include a control group for ethical reasons.~   "
57535|NCT02304029|"~     Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies~     refractory to drug treatment lead to increased morbidity, mortality and high costs for~     public health (representing 75% of the costs associated with epilepsy is among the most~     costly diseases in Neurology). The only curative therapy is surgical removal or~     disconnection of the epileptogenic network. To do this, a comprehensive presurgical~     evaluation is essential to accurately define the location of the epileptogenic zone (EZ) and~     its relationship with the functional areas that must be preserved. This approach requires in~     some cases intracerebral EEG recordings. This latter technique, expensive and invasive,~     remains at present, the standard method in the location of the ZE. In this context, the~     development of non-invasive and inexpensive methods is a priority in the field. Moreover,~     many fundamental studies have shown changes in ion homeostasis including sodium associated~     with hyperexcitability related to epilepsy. The investigators team at CEMEREM, CHU Timone,~     specialized in the development and validation of innovative methods in MRI, has developed an~     in vivo sodium MRI acquisition and processing of data unique in France, capable of~     quantifying the intracerebral sodium concentration in three dimensions in a completely~     non-invasive and non-irradiating manner~   "
57537|NCT02304003|"~     Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen~     is more effective than standard care in patients referred for arthroscopic surgery of the~     shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain,~     improve shoulder function and reduce the need for subacromial decompression surgery of the~     shoulder compared to standard care/wait and see controls.~   "
57538|NCT02303990|"~     Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in~     combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who~     have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who~     have have progressed after at least one regimen of systemic therapy (breast, pancreas, and~     other).~   "
57539|NCT02303977|"~     The main purpose of this study is to see how well the combination of Abraxane and~     gemcitabine works in people with advanced adenocarcinoma NSCLC who have already had~     treatment for their disease. Gemcitabine and Abraxane are FDA approved chemotherapies;~     however, the FDA has not approved this combination in the treatment of this specific type of~     cancer. Patients may continue to receive the study drugs until their disease gets worse or~     they have unacceptable side effects.~   "
57540|NCT02303964|"~     Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal~     Saline (NS) (standard of care) before arrival at the hospital.~      The purpose of this study is to determine if prehospital administration of thawed plasma can~     reduce mortality of patients who have lost a large amount of blood due to their injuries,~     compared to those receiving standard of care.~   "
57541|NCT02303951|"~     Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with~     vemurafenib + cobimetinib in patients with limited metastasis of melanoma in stage IIIC/IV~     melanoma.~   "
57542|NCT02303938|"~     The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility~     and to determine the effect size of an exercise program in improving objective cognitive~     functioning.~   "
57543|NCT02303925|"~     With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most~     frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the~     hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute~     complications (external and/or internal thromboses) are unpredictable.~      Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal~     pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler~     scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal~     surgery. This technique consists in a ligation of the superior rectal artery under Doppler~     control in order to decrease the blood flow within the hemorrhoids and therefore to reduce~     them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse~     (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia~     (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).~      With the major advances in interventional radiology such ligation could be performed by an~     endovascular coil embolization. Until now no direct study exists on the subject but several~     case reports show the feasibility of an embolization of the superior rectal arteries for~     rectorrhagia of various etiologies such as the hemorrhoidal disease.~      Endovascular access should increase the selectivity of the embolization compared to the~     Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches~     of the superior rectal artery and therefore to occlude permanently the branches that feed~     the hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the~     main complications of the trans-anal access technique.~      The primary objective of this study is : the assessment of the efficacy of endovascular coil~     embolization of the superior rectal arteries in the management of the symptoms of the~     hemorrhoidal disease grade II and III. The secondary objective is : the assessment of~     postoperative complications.~   "
57544|NCT02303912|"~     A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used~     in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which~     reappear after standard cancer treatment. The aim of the trial is to determine safety,~     effectiveness, and clinical activity of this combination treatment.~   "
57545|NCT02303899|"~     This is a phase II, monocentric study of the combination of gemcitabine and imatinib~     mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by~     Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient~     refusal or withdrawal of patient consent, or unacceptable toxicity~   "
57546|NCT02303886|"~     Aim of Investigation Methylene blue (MB) is a diaminophenothiazine with antioxidant,~     anti-inflammatory properties and with inhibitory effects on nitric oxide. The aim of this~     study was to determine the clinical effectiveness of MB in the treatment of neuropathic~     pain.~      Methods Ten patients with neuropathic pain were randomized to receive one of the two~     treatments: methylene blue (MB1) 2 mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå,~     Sweden) or methylene blue (MB2) 0.02 mg/kg. Both MB solutions were infused intravenously~     over 60 minutes. The sensory function and the pain were evaluated at baseline and at 60 min~     after the start of infusions. A pain journal was kept by the patients in the following 5~     days. Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α (8-iso-PGF2α) an~     indicator of oxidative injury, were measured with radioimmunoassay (RIA). A panel of 92~     proteins biomarkers were determined with Proximity Extension Assay (PEA) prior and after~     infusions.~      comparison with the control group. MB infusion produced an enhancement of prolactin.~   "
57547|NCT02303873|"~     Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI)~     because it significantly increased areal bone mineral density (BMD) and its Z score,~     decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted~     beneficial roles in different age brackets, especially in young patients with OI.~   "
57548|NCT02303860|"~     The purpose of this study is to evaluate ORM-12741 concentrations in blood at steady state.~   "
57549|NCT02303847|"~     This project is a pilot study to evaluate the analgesic and opioid-sparing effects of~     ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of~     chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.~   "
57563|NCT02303665|"~     Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on~     women with ART Failure; to compare the curative effect of the dual therapy and triple~     therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.~      Methods: The cases with ART Failure from West China second University Hospital of Sichuan~     University (West China Women's and Children's Hospital of Sichuan University) meeting the~     inclusion criteria were randomly divided into three groups: the dual therapy group, the~     triple therapy group and the control group, compare the natural pregnancy number, the~     condition during the period of secondary IVF-ET and the improvement of the kidney~     deficiency, liver depression and blood stasis syndrome among those three groups.~   "
57564|NCT02303652|"~     This study aimed at evaluating multiple aspects of biatrial contractility recovery after~     modified maze procedure during mitral valve surgery.~   "
57550|NCT02303834|"~     Study design:~      Single blinded randomised control trial~      Planned sample size:~      30 (women randomized 2:1 to receive either CPAP or no CPAP)~      Objectives:~      Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures~     and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.~      Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal~     well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep~     studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR~     monitors.~      Study Procedure:~      Participants will be recruited from the antenatal ward or high-risk antenatal clinic.~     Following informed consent participants will be randomly assigned to receive either CPAP or~     no CPAP for one night, following an initial baseline overnight sleep study.~      Baseline- Night 1~        1. Sleep study with fetal movement and HR monitor~        2. 24 hour BP monitor~        3. CO2 monitor~      Intervention- Night 2 (Nasal CPAP device or no CPAP)~        1. Sleep study with fetal movement and HR monitor~        2. 24 hour BP monitor~        3. CO2 monitor~      Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks~     post-partum related to the participant's personal health, their child's birth details and~     health.~   "
57551|NCT02303821|"~     The purpose of the study is to determine the maximum tolerated dose and assess the safety,~     tolerability and activity of carfilzomib, alone and in combination with induction~     chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).~   "
57552|NCT02303808|"~     This trial aims to analyze whether the inhalation of hypertonic saline combined with a~     positive expiratory pressure (PEP) device increases the amount of sputum expectorated during~     the chest physiotherapy session ( inhalation + bronchial drainage).~   "
57553|NCT02303795|"~     RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).~   "
57554|NCT02303782|"~     This study is designed in its first part (phase Ib) to determine the recommended dose of the~     OTX015 + Vidaza (azacitidine) combination in newly diagnosed acute myeloid leukemia patients~     not candidate for standard intensive induction therapy.~      It will be followed by a randomized phase II part to assess the efficacy of the combination~     using 2 arms : Vidaza (azacitidine) alone vs. OTX015 in combination with Vidaza~     (azacitidine).~   "
57555|NCT02303769|"~     Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet~     in benign prostatic hyperplasia patients with lower urinary tract symptomatic~   "
57556|NCT02303756|"~     The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection~     of neoplasms compared to conventional colonoscopy in persons participating in the Danish~     screening program for colorectal cancer with a positive fecal occult blood with the~     colonoscopy being the gold standard.~   "
57557|NCT02303743|"~     Getting ready for a colonoscopy is difficult and involves a lot of steps. The information~     given to patients is very important to adherence to treatment. The investigators have~     created a novel smart phone application (SPA) aimed to increased bowel preparation quality~     and patient satisfaction, using different educational tools.~   "
57558|NCT02303730|"~     The purpose of this study is to evaluate whether exenatide is superior to insulin glargine~     (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed~     type 2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).~   "
57559|NCT02303717|"~     A prospective, randomized, multicenter study in patients with an indication for coronary~     artery revascularisation who have been accepted for percutaneous coronary intervention (PCI)~     of the left main coronary artery. Patients will undergo standard PCI of the left main~     coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the~     XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy~     arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100~     patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months~     after treatment.~   "
57560|NCT02303704|"~     In spite improvements in methods of myocardial protection, peri-operative myocardial damage~     is still the commonest cause of early morbidity and mortality after technically successful~     CABG Surgery. What is the optimum method of myocardial protection is still debatable.~      The investigators conducted this study to see effects of multiport antegrade cold blood~     cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion~     through veins graft during proximal ends anastomosis in conventional CABG surgery in~     patients having multi-vessel disease.~   "
57561|NCT02303691|"~     This project seeks to identify neural mechanisms underlying the tendency for anxious~     individuals to pay more attention to threatening information than to other types of~     information. A computerized treatment designed to train individuals to reduce their~     attention towards threat will be tested, with a focus on understanding the aspects of brain~     function that are involved in response to the treatment. This work could ultimately lead to~     the ability to treat anxiety more effectively by directly targeting the aspects of brain~     function that are altered in a given patient.~   "
57562|NCT02303678|"~     This is a Phase I study to determine the maximum tolerated dose (MTD) of D2C7-IT (D2C7~     Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to~     recurrent World Health Organization (WHO) grade III (dose escalation only) and IV (dose~     escalation and dose expansion) malignant glioma patients, and to determine what dose will be~     considered in a single-arm Phase II trial. Patients with recurrent WHO grade III (dose~     escalation only) and IV (dose escalation and dose expansion) malignant glioma who meet~     eligibility criteria will be enrolled into the study. Immediately following~     stereotactically-guided tumor biopsy, subjects will have catheters inserted. If the frozen~     section of the biopsy indicates a proven diagnosis of recurrent malignant glioma (diagnosis~     results are typically received within 24-48 hours following biopsy), the investigators will~     proceed with the D2C7-IT infusion. If not, the catheters will be removed. A continuous~     intratumoral infusion of D2C7-IT will be administered and the same total flow rate for all~     catheters will be set at 0.5 ml/hour per catheter for 72 hours.~   "
57565|NCT02303639|"~     The study evaluates whether catheter based radiofrequency ablation is superior to optimized~     antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in~     patients with ischemic heart disease and implantable cardioverter defibrillator.~   "
57566|NCT02303626|"~     This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in~     preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects~     will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study~     will compare the number of acute attacks in each treatment group, as well as a number of~     other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to~     placebo.~   "
57567|NCT02303613|"~     Background: Triage in the emergency department (ED) together with initial assessment is used~     to identify patient's level of urgency and treatment based on their triage level. Triage in~     the ED is a complex decision-making process, and several triage scales have been designed as~     decision support systems to guide the triage nurse to a correct decision. Worldwide there~     are four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden~     introduced a process-oriented triage scale with physiological parameters called Rapid~     Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables:~     vital signs and chief complaints, which describe the incident or symptoms that caused the~     patient to seek care. These two variables are evaluated and results in a color coded 5-level~     scale. Each level of priority has a defined time limit within which evaluation by a doctor~     should begin. Although, all international triage system guidelines seem to function well in~     western countries, they are difficult to implement and have a high failure rate in~     developing low-income countries. One of the reasons may be the lack of extensive training.~     Teaching and assessing abilities in performing mass casualty triage in inherently~     challenging due to the inability to accurately replicate a given disaster environment in a~     comprehensive way. Disaster drills and simulation exercises are ways of training triage~     performance and there are different tools available. One tool that can contribute to this~     kind of training may be the Emergo Train System® (ETS). ETS or similar interactive~     educational simulation systems could be used to test and evaluate incident and command~     systems, surge capacity, hospital preparedness and triage.~      Study objective study III: The aim of the study is to validate the currently practiced~     system for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with~     RETTS. Furthermore map the current patient outcome of trauma patients.~   "
57568|NCT02303600|"~     Cough is a common symptom of respiratory medicine clinic patients, which has complex~     etiology and wide-ranging. Cough is usually divided into three categories by time: acute~     cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its~     main etiology is postinfectious cough, which is mostly secondary to viral~     infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene~     (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a~     significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in~     vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a~     role of controlling airway inflammation and decrease airway high activity by suppressing the~     biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by~     Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim~     is to research whether FENO can be used as a biomarker to optimized treatment regimen of~     sub-acute cough.~   "
57569|NCT02303587|"~     The study is designed to investigate difference in percentage of presentation of~     atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after~     discharge in those treated with a low dose regimen of methylprednisolone initiated with 2 or~     4 mg/kg/d for 3 days followed by tapering, combined with sequential treatment with~     azithromycin versus a high dose regimen of methylprednisolone initiated with 10 mg/kg/d for~     3 days followed by tapering, combined with sequential treatment with azithromycin.~   "
57570|NCT02303574|"~     This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the~     safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and~     multiple oral doses of AZD7986 in healthy volunteers~   "
57571|NCT02303561|"~     Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health~     outcomes including poor asthma control, higher risk of asthma-related symptoms, and~     decreased quality of life. Weight loss reduces asthma symptoms, improves lung function, and~     increases quality of life among OV/OB adults with asthma. Little research has examined the~     impact of weight loss on asthma outcomes in OV/OB youth, and there is little research~     examining weight management interventions in OV/OB children with asthma. Behavioral~     family-based lifestyle interventions are successful in producing weight loss in children. To~     our knowledge, however, there has been no systematic effort to examine the impact of these~     interventions on weight status and asthma outcomes, nor has there been an effort to tailor~     these programs to the specific needs of OV/OB children with asthma.~      The aims of this study are to develop and test the Childhood Health and Asthma Management~     Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to~     promote successful weight and asthma management in OV/OB children with asthma. The~     investigators propose to develop an intervention based on a previously developed behavioral~     family-based lifestyle intervention that was community-based and produced positive long term~     weight status changes in OV/OB children and tailor it for OV/OB children with asthma to~     create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight~     management in OV/OB children with asthma. A focus group will be conducted with OV/OB~     children with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled~     trial of the CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and~     their parent(s). Families will be randomly assigned to CHAMP or a health education group.~     The investigators hypothesize that participants in CHAMP will have more effective weight and~     asthma management and child asthma outcomes compared to those in the general education~     group.~   "
57572|NCT02303548|"~     A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary~     resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.~   "
57573|NCT02303535|"~     The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and~     produces analysis to enable hospitals and healthcare improvement bodies to monitor and~     improve the quality of care and outcomes of cardiovascular patients.~      The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic~     cardiac catheterisations procedures used to treat patients with congenital and acquired~     heart disease.~      For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients~     less than 16 years old only. For congenital heart disease, the audit collects data on both~     children and adult patients. The audit covers all specialist centers in the UK and Republic~     of Ireland.~      The project aims to improve the quality of care for children and adults with congenital~     heart disease by providing national comparative analysis of procedure specific activity and~     outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit~     also provides quality indicators for the antenatal detection of major congenital heart~     disease.~      The current dataset is available from here:~      http://www.ucl.ac.uk/nicor/audits/congenital/datasets~   "
57574|NCT02303522|"~     An historical data comparator study for children with relapsed/refactory acute lymphoblastic~     leukemia (ALL).~   "
57575|NCT02303509|"~     To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single~     doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The~     study uses healthy and psoriasis subjects.~   "
57590|NCT02303314|"~     This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of~     non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients~     select and then randomize into intervention and control groups. Two group use capsules which~     contain TFG or placebo, respectively.~   "
70175|NCT02138812|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II~     dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced~     malignancies.~   "
57576|NCT02303496|"~     Human skin undergoes some morphological changes with the effects of chronological aging and~     photoaging, these are especially remarkable in the facial skin. Changes in pigmentation,~     sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and~     chronologic aging of skin. With the increasing demand, it needs to provide new approach for~     the prevention and treatment of these morphological changes.~      Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates~     the fibroblasts and increases the synthesis of collagen and other type of matrix components.~     Because of these specialities, platelet rich plasma is thought to be effective on skin~     aging.~   "
57577|NCT02303483|"~     In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism.~     It is currently not know if vitamin B3 has the same positive effects in humans. In the~     current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and~     substrate metabolism in obese men will be investigated.~   "
57578|NCT02303470|"~     This study evaluates the feasibility and metabolic effects of implementing a structured~     exercise program in women with polycystic ovary syndrome and insulin resistance.~     Participants will be randomized to either 75 minutes of vigorous exercise or 150 minutes of~     moderate exercise per week.~   "
57579|NCT02303457|"~     Open surgery and CO2 laser surgery are both established treatment modalities for T1N0~     glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure~     involved.~   "
57580|NCT02303444|"~     The purpose of the study is to assess the use of Multikinase Inhibitors (MKIs) in the~     treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory~     to radioactive iodine (RAI) who do not have any symptoms.~   "
57581|NCT02303431|"~     This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a~     single dose of edoxaban will be given to pediatric subjects who require anticoagulant~     therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to~     the body (pharmacodynamics), and to compare if these effects are similar to those observed~     in adults.~   "
57582|NCT02303418|"~     The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic~     PPH in women undergoing CS for placenta previa.~      200 women will be randomly divided into 2 equal groups using computer generated random~     numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).~   "
57583|NCT02303405|"~     A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs.~     pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated~     doses of metformin plus a sulfonylurea.~   "
57584|NCT02303392|"~     This phase I trial studies the side effects and best dose of selinexor when given together~     with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive~     non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to~     treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a~     better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.~   "
57585|NCT02303379|"~     It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried~     out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance~     training, on changes of physical exercise capacity in cardiac patients.~   "
57586|NCT02303366|"~     This is a prospective, observational pilot study that will describe the safety profile and~     biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment~     (20Gy/1#) and a PD-1 antibody, MK-3475.~      15 patients with oligometastatic breast cancer with at least one lesion considered safe for~     SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition~     to 6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles).~      This investigator driven pilot study will examine the safety and biological effects of~     combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell~     death 1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We~     hypothesise that the safety profile of this combination, will be clinically acceptable and~     well tolerated for patients, and that we will observe evidence of systemic immune~     activation.~   "
57587|NCT02303353|"~     The purpose of this registry is to evaluate the situation regarding ambulant therapy of~     cancer patients in different practices in Germany. It should provide insight into the~     implementation of schemes for cancer therapy predefined in the guidelines, the treatment of~     diverse adverse reactions and the counter measures taken. Thereby, potential differences in~     treatment and with that differences in quality amongst individual practices might be~     identified. The medium to long term aim is to contribute to positively influence the quality~     of medical care of cancer patients in Germany.~   "
57588|NCT02303340|"~     The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography~     (CBCT) in assessment of bone density. The study population contains men and women above the~     age of 60 years, eligible for Bone Density Testing in accordance with their health~     insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient~     (eligible for bone density screening by age criteria) undergoing CBCT of either one of the~     jaws (or both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and~     for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels.~      Density measurements will be done in specific sites on the CBCT's of the jaws. These~     measurements will be correlated with the blood tests and DEXA scan results.~   "
57589|NCT02303327|"~     In North America, the number of new cases of prostate cancer increases every year. Many~     efforts have been made to develop more efficient and safer curative treatments for high risk~     prostate cancer patients.~      This phase III clinical trial is designed to compare the safety of a standard pelvic~     external beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB)~     boost (direct insertion of radiation source over a period of minutes via flexible needles~     temporarily inserted in the prostate) to a shorter course of hypofractionated dose~     escalation radiotherapy (larger radiation dose per daily treatment) in patients with high~     risk prostate cancer.~      The investigators plan to recruit 296 patients across Quebec who will be randomized in~     either treatment plan.~   "
57591|NCT02303301|"~     Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in~     their oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx~     Probiotics can reduce such bacteria in intubated critically ill patients This study will use~     two strain of probiotic bacteria for half of the patients and a placebo for the rest Active~     arm gurgles with a suspension twice a day Cultures at inclusion and at set time intervals~     The results of cultures from the two groups will be compared as will the use of antibiotics~   "
57592|NCT02303288|"~     This is a post-market study of the Argus II Retinal Prosthesis System. The study is being~     conducted in France. The objective of the study is to obtain data to further demonstrate the~     effectiveness and evaluate the safety of Argus II System in patients with retinitis~     pigmentosa who have a bare light perception or worse in both eyes.~   "
57593|NCT02303275|"~     Summary~      Chronic heart failure continues to be one of the highest economic burdens in the United~     States, heavily influenced by frequent readmissions to the hospital. This study will examine~     whether patients 65 years and older, who have NYHA class II and III heart failure, will~     improve their symptoms after participating in a comprehensive 12-week lifestyle change~     program. The investigators will recruit potential subjects primarily from the Scripps Clinic~     heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to~     medical treatment as usual or the lifestyle program. The investigators will enroll 17~     subjects into each group which will provide 80% power and an alpha of 0.05.~      The lifestyle change program consists of classes conducted three times a week for 12 weeks~     at the Scripps Center for Integrative Medicine. Each day participants will spend about four~     to five hours in a variety of classes such as monitored exercise, group support,~     mindful-yoga and meditation, vegetarian cooking classes, music-centered wellness, mind-body~     lectures, and resiliency training.~      The primary outcomes will focus on determining functional status and physical agility using~     the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the~     investigators will capture subjective physical status with a self-reported questionnaire.~     Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To~     capture the subject's overall self-reported improvement the investigators will use a quality~     of life and a depression questionnaire. Secondary endpoints include hospital admission rates~     and all-cause mortality.~   "
57594|NCT02303262|"~     The purpose of this study is to assess the response rate (per RECIST 1.1) in participants~     who receive mocetinostat and gemcitabine after documented progression of leiomyosarcoma on a~     gemcitabine containing regimen.~   "
57595|NCT02303249|"~     The study aims to assess whether the review of discharge planning followed by a~     cross-sectoral video conference in connection with discharge of medical and geriatric~     patients at Roskilde and Køge hospitals as well as patients from the Emergency Department at~     Køge Hospital reduces the proportion of patients who are readmitted within 180 days.~      Project nurses at the two hospitals identifies all patients fulfilling the inclusion~     criteria (above 55 years of age, discharged to their own home), get informed consent and~     performs the video conferences. Within a few hours after discharge a video conference is~     held in the patient´s home including the patient,the municipal nurse and the project nurse~     at the hospital. During the video conference the discharge is reviewed using a structured~     assessment.~      The survey is conducted as an open, randomized intervention study.~   "
57596|NCT02303236|"~     Establishing the association between biological markers and exercise capacity in~     continuous-flow left ventricular assist device patients.~   "
57597|NCT02303223|"~     The principle objective of this study is to evaluate pharmacokinetics of propofol after~     single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of~     propofol.~   "
57598|NCT02303210|"~     The purpose of this study is to examine two frequency lowering techniques in case of~     audibility, recognition, distinction, discriminability and sound quality.~   "
57599|NCT02303197|"~     This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer~     patients with radioactive stomatitis. Half of participants will receive ChiNing decoction,~     while others will receive recombinant human epidermal growth factor (rhEGF) spray.~   "
57600|NCT02303184|"~     A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed~     to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA,~     triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT)~     injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein~     occlusion (RVO).~   "
57601|NCT02303171|"~     Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of~     using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with~     antiphospholipid syndrome (APS)~   "
57602|NCT02303158|"~     It is currently accepted that depression during midlife is a risk factor for Alzheimer's~     disease (AD). Furthermore, several prospective population studies have demonstrated that~     depression is an independent risk factor for incident dementia of different types (e.g.~     vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms~     that link depression and dementia, and if depression can be a prodromal manifestation of AD.~     There are also studies that suggest that depression could be an initial sign of AD.~      Objective:~        1. Demonstrate that late life depression (over 60 years of age) constitutes the first~          manifestation of AD.~        2. Define by rating scales and life stressors have differential risk profiles evolutionary~          AD.~        3. To study the relationship between the subtypes of depression and CSF biomarkers,~          neurophycological test and evolution to AD.~   "
57614|NCT02303002|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar~     frown lines.~   "
57615|NCT02302989|"~     To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related~     Macular Degeneration~   "
57616|NCT02302976|"~     The investigators plan to explore the effects of acute pre-treatment with the glucagon like~     peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and~     behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment~     seeking users of the drug. Additionally, the investigators plan to explore the effects of~     sub-chronic (5-day) treatment with exenatide as compared to placebo on the subjective (e.g.,~     euphoric) and behavioral (self-administration) effects of cocaine in experienced,~     non-treatment seeking users of the drug.~   "
57603|NCT02303145|"~     The proposed study seeks to evaluate the relationship between biopsychosocial functioning~     and work-related cognitive limitation among employed breast cancer survivors in a~     cross-sectional study with healthy control group. Specifically, this study will assess~     work-related cognitive limitation in association with depression, anxiety, pain, fatigue,~     sleep disturbance, and cognitive deficit of employed women with and without history of~     breast cancer. The primary purpose of this study is to assess the impact of objective~     cognitive functioning as a better predictor of cognitive shortcomings at work place in~     comparison to a self-report cognitive measure. The secondary purpose is to assess work~     related cognitive limitation in breast cancer survivors in comparison to their counterparts~     (employed women without history of cancer diagnosis). The third purpose is to explore how~     sociodemographic variables such as marital status, education, age, race, and ethnicity~     relates to perceived cognitive limitation at work among breast cancer survivors.~     Additionally, the study will examine the effects of medical variables as covariates on these~     relationships. Subsequently, the study will examine the level of mindful attention and~     awareness as a possible mediator between the psychological, somatic and cognitive distress~     and the work-related cognitive limitation.~      In this observational study, the control group is added as a mean to compare differences~     between groups and that no variables is being manipulated in this study. This precludes this~     research from being a quasi- or a true experimental design.~   "
57604|NCT02303132|"~     Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor~     for MC development. However, the exact pathophysiological mechanism is unclear. It is~     hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due~     to an idiosyncratic reaction which results in a local immune response. MC patients are~     considered to be susceptible hosts, prone to react on administration of abovementioned~     drugs. In order to test this hypothesis and to generate new insights in the pathophysiology~     of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The~     primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial~     permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber~     system~   "
57605|NCT02303119|"~     Patient will receive either one infusion of rituximab IV and seven administrations of~     rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).~      The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of~     administration could:~        -  optimize rituximab exposure leading to improve response rate~        -  increase adaptative response and then improve long-term control disease.~   "
57606|NCT02303106|"~     The investigators will study the effect of paracetamol on the steady state metabolism of~     lamotrigine in 12 healthy male volunteers.~      Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28~     days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject~     will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be~     repeated.~      Primary outcome parameter is Lamotrigine AUC before and after coadministration of~     paracetamol.~   "
57607|NCT02303093|"~     Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%~   "
57608|NCT02303080|"~     The main objective of the trial is to measure the thermogenic effect of two different doses~     of whey protein microgels.~      It will be a randomized crossover double-blind design conducted in 20 subjects.~   "
57609|NCT02303067|"~     Background:~      - This study is designed for people who need a standard, non-research invasive coronary~     angiogram to find out if they have heart disease. Researchers want to take a computed~     tomography (CT) scan of people s hearts before their procedure to see if this less invasive~     test can also diagnose coronary artery disease.~      Objectives:~      - To learn if a new way to view CT pictures is able to accurately diagnose coronary artery~     disease.~      Eligibility:~      - People age 55 and older who need a coronary angiogram.~      Design:~        -  Participants will be screened with their medical records.~        -  Participants may give a blood sample.~        -  Participants may have a CT scan of the heart with and without contrast. The CT scan~          will not interfere with their medical care.~        -  Participants blood pressure and heart rhythm will be monitored before, during, and~          after the CT scan. They may have an electrocardiogram.~        -  Before the scan, participants will have an intravenous catheter put into their arm. It~          will be used to inject contrast.~        -  Participants may take a beta blocker to slow their heart rate.~        -  Participants may take nitroglycerin under their tongue. It will enlarge their heart~          blood vessels and improve picture quality. It may cause a flushing sensation or~          headache.~        -  Participants will lie on their back on a padded table. The table slides into a large,~          donut-shaped machine. An x-ray tube will move around their body, taking pictures. They~          will be asked to hold their breath for 5 seconds at a time.~        -  Participants will be called 30 days after their angiogram. They will answer questions~          about their health, hospital visits, or medical treatments.~   "
57610|NCT02303054|"~     This is a prospective single center trial to examine the rate of negative biopsy result and~     quality of life after focal ablation by radiofrequency energy. The primary evaluation~     involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months~     after focal ablation of the prostate. Urinary and sexual quality of life will be assessed~     through validated measures. The hypothesis of our study is that focal ablative therapy will~     result in a greater likelihood of negative biopsy on followup biopsy than that observed in~     men who elect not to undergo therapy.~   "
57611|NCT02303041|"~     This pilot trial studies how well sonidegib and buparlisib work in treating patients with~     basal cell carcinoma that has spread to other places in the body. Sonidegib and buparlisib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
57612|NCT02303028|"~     This is a phase I, dose escalation study where topotecan will be administered at lower doses~     given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination~     with a fixed dose of pazopanib. The maximum tolerated dose (MTD) and the recommended phase 2~     dose (RP2D) will be evaluated for LDM topotecan in combination with pazopanib in children~     with recurrent or refractory solid tumours including CNS tumours. Pharmacokinetic and~     pharmacodynamic studies will be conducted to further define the exposure to and activity of~     LDM topotecan in combination with pazopanib.~   "
57613|NCT02303015|"~     The purpose of this study is to identify genetic variations in survivors of testicular~     cancer and connect these variations to differences in risks of late effects.~   "
57618|NCT02302950|"~     Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved~     in 2007. It is currently one of the preferred treatment regimens for HIV by the Department~     of Health and Human Services. It has become a widely used antiretroviral therapy option for~     HIV infected patients. It provides good tolerability and a favorable lipid profile for~     patients when compared to some other antiretroviral treatment options. Little data is~     reported about efficacy in a minority patient population. Moreover, data in an indigent~     minority population in the United States has not been aggregated before. Therefore this~     study will investigate the efficacy of raltegravir in minority women residing in Houston, TX~     who are HIV infected.~   "
57619|NCT02302937|"~     This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia~     using a mesh carried out with only 1 port (hole) results in the reduction of post- operative~     pain and use of painkillers, shorter hospital stay and lesser complications than that~     carried out using conventional 3 ports.~   "
57620|NCT02302924|"~     There is no standardized method for evaluating the symptoms of influenza. A standardized~     instrument for measuring influenza symptoms, with appropriate scientifically derived content~     and construct validity would have value for public health in terms of use as a validated~     outcome measure in interventions to treat or prevent influenza. The instrument also could~     serve as part of an overall measure of severity of illness in influenza. Previous efforts in~     participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II)~     focused on the elicitation and evaluation of items for inclusion in the instrument. The~     overarching objective of this protocol - Flu-PRO Stage III - is to conduct instrument~     validation to evaluate item properties and, if need be, reduce the number of items, and~     quantitatively validate the performance of the final measure.~   "
57621|NCT02302911|"~     This study aims to investigate the effectiveness of early (before the age of 5 years) and~     intensive intervention for children with Autism Spectrum Disorders.~   "
57622|NCT02302898|"~     This study compares eating behaviors, meal size, and the size of the gastric pouch and~     connection between the gastric pouch and small intestine in patients who had gastric bypass~     surgery two or more years ago and regained weight compared with patients who had gastric~     bypass surgery two or more years ago and maintained their weight loss.~   "
57623|NCT02302885|"~     Human blood will be collected to serve as control in validating clinical studies studying~     the detection and levels of circulating tumor cells and microvesicles in cancer patients.~     Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will~     rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers~     up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort,~     bruising) to the volunteer.~   "
57624|NCT02302872|"~     The objective of the study is to evaluate the safety and performance of the ARTO System in~     patients with mitral valve regurgitation (MR) associated with congestive heart failure~     (CHF).~   "
57625|NCT02302859|"~     The goal of this research study is to learn about 2 different interactive methods that are~     designed to help people with HIV/AIDS stop smoking.~   "
57626|NCT02302846|"~     The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from~     coming back in patients who are in remission. The safety of this drug will also be studied.~   "
57627|NCT02302833|"~     The goal of this clinical research study is to learn if cabozantinib can help to control~     advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also~     be studied.~   "
57628|NCT02302820|"~     This study begins to look at ways nurses in primary care might help patients engage in~     Advance Care Planning and communicate their values and preferences to family and doctors.~   "
57629|NCT02302807|"~     This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study~     designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in~     participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have~     progressed during or following a platinum-containing regimen. The anticipated time on study~     treatment is based on continued clinical benefit, i.e., until disease progression or~     unacceptable toxicity. The target sample size is 932 participants.~   "
57630|NCT02302794|"~     evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach~     distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current~     standard surgical treatment model D2 open approach distal gastric resection (distal~     gastrectomy, D2 lymphadenectomy).~   "
57631|NCT02302781|"~     Dropout rates for fertility treatments are high. This study will examine the rate of~     patients that drop out during any type of subfertility work up or treatment. Furthermore, we~     will determine what reasons for discontinuation are and we will identify the demographic~     characteristics of the couples and the prognostic factors for drop out during assessment or~     treatment at a Fertility Centre in the Isala (Zwolle), Erasmus University Centre~     (Rotterdam), St Elisabeth Hospital (Tilburg) and IVF Clinic Voorburg (Voorburg) in The~     Netherlands.~   "
57632|NCT02302768|"~     Over the past 10 years, several clinical studies have suggested that selenium~     supplementation may influence the natural history of AIT. Recently, Interferon gamma~     (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT~     patients. The aim of this prospective, randomized, controlled study is to evaluate the~     effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in~     euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement~     of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11~     and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and~     volume and the quality of life of AIT patients are also evaluated.~   "
57633|NCT02302755|"~     The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and~     adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients~     with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3~     breakdown products, or alternative pathway (AP) complement activity.~   "
57634|NCT02302742|"~     PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who~     have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).~   "
59665|NCT02276222|"~     This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week,~     open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice~     a day or Spiriva® [tiotropium] given as 18 mcg once a day).~   "
57635|NCT02302729|"~     Over 200 million children under the age of 5 years in low and middle-income countries do not~     reach their developmental potential, largely due to lack of adequate nutrients and lack of~     psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of~     chronic undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere~     (over 40%). This trial examines the effect of providing a micronutrient powder manufactured~     in Guatemala vs. placebo and an early learning environment vs. no early learning environment~     on the growth, health, and development of young children in Guatemala.~   "
57636|NCT02302716|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on~     2 or more oral antihyperglycemic medications (OAMs).~   "
57637|NCT02302703|"~     Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be~     relieved with defecation and a change in stool frequency and consistency. Its prevalence~     among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is~     defined as gastrointestinal symptoms which increase with eating gluten-containing foods and~     improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and~     polyols) are carbohydrates that are not absorbed well in the small intestines, therefore~     fermented by gut microbiota, increasing osmotic load at the intestine causing fluid shift~     and gas production. The patient suffers bloating, abdominal pain, flatulence and change of~     stool consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes,~     artificial sweeteners and soft drinks.~      Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on~     gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on~     research in adults.~      Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric~     gastroenterology team at Hadassah. All children will record one week of baseline diet and~     symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week,~     together with a washout period of one week between the diets. During the two weeks of~     intervention diets, the children aided by their parents will document and score symptoms~     (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure~     the anticipated influence of each diet against baseline diet and symptoms.~      Expected results: In previous studies, a change in symptoms was viewed within a few days. We~     expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.~   "
57638|NCT02302690|"~     The proposed research protocol aims at addressing these points by pre-screening CN patients~     for their AAV serology in link with their medical history and current medical status. A~     first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN~     patients.~   "
57639|NCT02302677|"~     This is a prospective study of meal-induced bile acid physiology before and after sleeve~     gastrectomy (SG) surgery. Weight loss and metabolic improvement associated with weight loss~     surgery cannot be entirely attributed to restriction in stomach size and food intake. Bile~     acids (BAs), amphipathic steroids that have a role in lipid uptake and metabolism in the~     gastrointestinal tract, are involved in post-prandial glucose homeostasis and energy~     expenditure, and are a potential intermediary in weight loss following bariatric surgery. It~     is unknown if SG increases post-prandial BAs in humans and if an increase in BA signaling~     impacts weight loss and co-morbidity resolution after surgery. The investigators hypothesis~     is that SG will increase the post-prandial serum and urine BAs and that the change in the BA~     profile is a mechanism for restriction-independent weight-loss following SG. 32 eligible,~     adult, morbidly obese human subjects will be recruited by the Clinical Research Center at~     UNMC. These subjects will be evaluated in a multi-disciplinary fashion, approved, and~     consented to have a SG at UNMC. Subjects will be eligible for the study if they meet these~     criteria: between 19 and 70 years old, participant in the Surgical Weight Loss Program of~     the Bariatrics Center of University of Nebraska Medical Center (UNMC), approved to have a SG~     at UNMC, have SG as the primary bariatric surgery or prior lap band placement and removal~     over two years prior to the surgery. Medical charts of participants will be reviewed and~     pertinent data from time of surgery will be abstracted. Subjects will be excluded from the~     study if have a past history of small bowel resection or right colectomy, cirrhosis, current~     or planned use of BA sequestrants, or bariatric surgery performed as a revisional procedure.~     SG patients will undergo a meal challenge pre-operatively, and at 1, 3, and 12 months~     post-operatively, with measurement of post-prandial serum and urine BAs and downstream~     hormones, glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 19 (FGF19), and a~     scoring of satiety before and after the meal challenge using a Visual Analog Scale. Serum~     insulin, glucose, and C4 levels will also be measured to assess metabolic changes associated~     with SG. Serum and urine BA levels will be compared to post-operative excess weight loss at~     12 months. Before and after each meal challenge, patients will be asked to score satiety,~     and this will be correlated to weight loss, bile acids, GLP-1, and FGF19.~   "
57640|NCT02302664|"~     Platelet Rich Plasma in Achilles Tendon Healing~      Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting~     benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles~     tendon rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial~     with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.~      ATR is the most common tendon injury and leads to months of incapacity. With an average work~     absence of 63108 days there are significant societal and National Health Service (NHS)~     costs. PRP potential benefit is to improve recovery and return to normal activities earlier,~     and reduce the NHS and societal impact. The investigators will investigate the efficacy of~     PRP using disease specific and patient important outcomes to improve the evidence for this~     treatment of ATR.~      A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214~     participants. Patients will be identified in the orthopaedic outpatient clinic, usually~     following an emergency hospital attendance for ATR. After checking eligibility and the~     informed consent process, baseline data is collected and participants randomised to either~     'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is~     taken and prepared according to allocation. The injection is delivered by a trained surgeon~     in clinic who will be aware of allocation while the participant remains blind.~      Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks,~     carried out by a member of the research team blind to allocation. Assessments take place~     over the telephone or during a hospital outpatient visit. The 24 week hospital visit~     includes an exercise test of ankle function. All assessments include collection of patient~     reported responses to pre-set questions.~      The results may be applicable to the many other tendon and ligament injuries. The National~     Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism~     Evaluation Programme provides funding and University of Oxford is Sponsor.~   "
57641|NCT02302651|"~     Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused~     ultrasound. This study is designed as an intention-to-treat using a totally non-invasive~     approach for pain reduction, quality of life improvement and long-term bone restoration.~     Procedure is performed in a single session using limited amount of acoustic energy to target~     the osteoid nidus. Treatment will be performed under anesthesia (peripheral or general~     according to age and lesion position).~   "
57642|NCT02302638|"~     This prospective study with sibling oocytes will evaluate the efficiency of two commercial~     single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms~     of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates.~     Embryos will be cultured continuously for up to 6 days under identical conditions.~   "
59666|NCT02276209|"~     This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating~     the efficacy and safety of dasotraline in adults with ADHD.~   "
57643|NCT02302625|"~     Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and~     recurrent inflammatory eczema. It is one of the most common skin diseases and is associated~     with reduced quality of life, functional impairment and sleep difficulties. The present~     study aims to investigate a new exposure-based cognitive behavioral psychological treatment~     for the disorder. The trial is a small scale open trial (n=25) with assessments at baseline,~     post-treatment and 6-month follow-up. The primary outcome is the SCORAD.~   "
57644|NCT02302612|"~     Cardiovascular disease (CVD) is the leading cause of death in the U.S. Efforts to improve~     CVD risk factors often fall short in complex patients with multiple co-morbid conditions, a~     growing, expensive, and high-risk segment of the U.S. population. The investigators are~     testing a multi-component behavioral intervention designed to help complex patients with CVD~     and other concurrent chronic conditions to become more effective agents of their own care.~   "
57645|NCT02302599|"~     Between umbilical cord mesenchymal stem cells by the secretion characteristics, secrete a~     variety of cytokines and its immune inhibition, promoted the islet cell repair and~     regeneration, improve the state of high blood sugar in the body.~   "
57646|NCT02302586|"~     Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which~     is also a predictor of chronic pain. In this study, the investigators aim to compare the~     postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient~     controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.~   "
57647|NCT02302573|"~     Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part~     or the entire chorionic plate with penetration of chorionic villi in the myometrium and~     absence of the decidua basalis. This anomaly is associated with significant maternal~     morbidity and mortality as it may result in severe haemorrhage during the post-partum. It~     has been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal~     morbidity. In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to~     better outcomes, due to fewer emergency operations and less mass transfusions. Currently,~     the diagnosis of AIP is based on a combination of conventional B-mode ultrasound and MRI.~     However, prenatal diagnosis of AIP remains challenging and recent reports demonstrated it is~     achieved in only thirds of cases.~      Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by~     ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular~     rheological properties of these bubbles are similar to those of red blood cells and they~     remain entirely within the intravascular space. Previous studies have demonstrated that~     microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US~     imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet~     approved for clinical use, CEUS offers the opportunity to analyze anatomical placental~     landmarks, improving the contrast between placenta and myometrium. In addition,~     quantification parameters related to the contrast enhancement have been proposed as~     objective indicators to estimate blood perfusion rates in the placental intervillous space.~      The main objective of this study is to provide pre-clinical evaluation of CEUS for the~     diagnosis of AIP and to try to determine if AIP are characterised by differences in~     intervillous blood rheological properties. Conventional CEUS parameters will be: rise time,~     peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.~      As this study is a pre-clinical evaluation, sample size calculation remains subjective and~     imprecise. For this reason, a sample size of 100 pregnant women to be included in this~     prospective study has been decided.~      The potential impact of this study will be to propose a more reliable tool with both~     improved sensibility and specificity compared to the combination US/MRI and therefore to~     reduce the maternal worldwide burden of AIP.~   "
57648|NCT02302560|"~     The purpose of this prospective observational study is to investigate the changes in sleep~     architecture after a hip surgery and its potential association with postoperative delirium~     and postoperative cognitive dysfunctions respectively.~   "
57649|NCT02302547|"~     In the early 2000s, the TRILEGE© study was realized to determine if the reductive anti~     retroviral strategy from an initial triple therapy (based on a protease inhibitor as the~     third agent) towards a dual therapy of nucleoside analogs (in particular the association of~     zidovudine +lamivudine) for patients infected by HIV and stabilized for at least 3 months~     at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic~     viral load, with an aim to reduce the long-term side effects of the treatment.~      The afore mentioned study showed that the reductive anti retroviral strategy was a failure.~     No study has as yet to revaluate this strategy, in particular in the current context of~     antiretroviral treatments.~      Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as~     a superior intrinsic power as compared to treatments proposed in the initial TRILEGE©~     study. Furthermore, the better quality of current triple therapy (as compared to that used~     10 years ago) has lead to substantial viral reservoir reduction.~      Currently, a small number of patients is being successfully treated in the long-term (viral~     load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of~     these patients have yet to be thoroughly investigated.~      The patients concerned were all treated prematurely before ever passing below 200~     lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir~     as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).~      Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA~     value and (3) a very good observance, the investigators emit the hypothesis that, reductive~     anti retroviral strategy that would consist in changing from a conventional triple therapy~     towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable~     control of viral replication with the concomitant benefice of reduced antiretroviral side~     effects and cost.~   "
57650|NCT02302534|"~     Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These~     different curves may be distinguished by different physiopathologic mechanisms.~      Without fully convincing model of the emergence and development of AIS, their multifactorial~     nature seems evident. Several pathophysiological theories involving the central nervous~     system have been proposed: the AIS would be associated with disturbances of proprioceptive~     or sensory perception, and/or with integration of this information. This would result in an~     abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the~     deformation.~      The Main aim of this study is to find cortical and subcortical morphometric differences in~     the most common population of AIS (right thoracic AIS) compared to healthy adolescent~     control girls.~      Secondary Objectives are to study the cerebral white matter of the same groups (fractional~     anisotropy in the main white matter tracts), and activation of sensorimotor neural networks~     (fMRI activation and functional brain connectivity).~      Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and~     classification.~   "
57651|NCT02302521|"~     The purpose of this study is to evaluate our recently developed MRI reconstruction strategy~     for producing artifact-free neuro and abdominal MRI data. The new reconstruction strategies,~     including 1) REKAM and 2) MUSE, are capable of effectively removing motion-related artifacts~     resulting from global and local motion during neuro and free-breathing abdominal MRI scans,~     without modifying the MRI pulse sequences and protocols that are currently used in clinical~     scans. The study team aims to recruit 60 subjects across multiple challenge patient~     populations: 10 healthy young adults (age 20-30) and 10 healthy older adults (aged 50-70)~     for abdominal MRI, as well as 20 tremor dominant PD patients and 20 children (age 4-8) for~     brain MRI scans. There are no known risks in taking MRIs and a unique code will be assigned~     to each participant to protect their PHI.~   "
57779|NCT02300844|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in~     normal weight, overweight to obese but otherwise healthy male subjects.~   "
57652|NCT02302508|"~     Clopidogrel efficacy appears diminished in patients with type 2 diabetes (T2D) who continue~     to show an increased risk of adverse cardiovascular events and mortality compared to those~     without T2D.The aim of the first project is to describe the pharmacokinetic (PK) profile of~     three antiplatelet drugs in 4 groups of patients according to their diabetic or non-diabetic~     status. To this end, PK profiles will be determined after a single oral dose of 300 mg~     clopidogrel, 60 mg prasugrel and 180 mg ticagrelor in patients (n=108); 1) with T2D and good~     glycemic control; 2) with T2D and poor glycemic control; 3) with insulin-treated diabetes;~     and 4) non-diabetic subjects.~   "
57653|NCT02302495|"~     IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with~     multiple myeloma at diagnosis. Study primary objectives are in the first step to determine~     Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting~     toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very~     Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in~     combination with Melphalan Prednisone at the end of the 9 induction cycles.~   "
57654|NCT02302482|"~     The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases~     because of their main features such as cognitive impairment, loss of functional autonomy and~     behavioural disorders. In absence of current curative treatment, the identification of the~     predictive risk factors of progression of the disease, evaluated through its main symptoms,~     represents a major stake of public health. The investigators aimed at developing a database,~     which includes the patient medical records on a prospective basis, in collaboration with the~     medical and administrative personal and with the University hospital computer science~     department. The main objective is to study the predictive factors associated with the change~     of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory~     Clinic. The study population would consist in about 1000 patients with ADRD. The length of~     follow-up of each patient will be 3 years.~   "
57655|NCT02302469|"~     The purpose of this study is to determine the recommended dose of lenalidomide in subjects~     with relapse and refractory Waldenstrom Macroglobulinemia.~   "
57656|NCT02302456|"~     The purpose of this study is to assess whether the administration of a low dose of~     tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum~     hemorrhage, in women who receive a prophylactic administration of oxytocin.~   "
57657|NCT02302443|"~     The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad~     pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.~   "
57658|NCT02302430|"~     This study attempts to identify the psychological, behavioral, physiological, and hormonal~     predictors and mechanisms of an individual's ability to develop cohesion in a group working~     together as a team; and examine if administration of the prosocial neuropeptide oxytocin~     enhances the development of team cohesion. Through a deeper understanding of the underlying~     psychobiological predictors and mechanisms of team cohesion, the prospective identification~     of individuals whose unique characteristics promote or inhibit the development of group~     cohesion will become possible.~   "
57659|NCT02302417|"~     The primary objective of the study is to identify demographic and non-spirometric clinical~     features predictive of the asthma-COPD overlap population. The study aims to explore and~     identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical~     profile that enable clinical differentiation from subjects with a primary diagnosis of~     either asthma alone (without persistent obstruction) or COPD alone (without reversibility).~     The study is designed as a targeted medical history survey which consists of a 41-item~     questionnaire, which will be administered by a qualified health care practitioner at the~     time a subject's medical history is taken. The questionnaire has been developed to elicit~     specific details of the respiratory history, including the following: bronchodilator use,~     disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias,~     burden of disease, symptom presentation, co morbidities and age of onset. In addition,~     demographic information, standard medical history, co morbidity and spirometric results will~     also be obtained and analyzed in conjunction with the questionnaire results. Approximately~     1000 subjects are required for the study.~   "
57660|NCT02302404|"~     This study is the first administration of GSK2982772 in humans. The study will evaluate the~     safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single~     and repeat oral doses of up to 14 days with GSK2982772 in healthy male subjects.~      This study is planned to include approximately 52 subjects and will consist of 2 parts: Part~     A - single ascending dose, randomized, placebo controlled, 4 way crossover. In addition to~     the crossover treatment periods, up to 8 subjects in cohort 2 will participate in an~     additional treatment period and receive GSK2982772 with a high-fat meal. Part B - repeat~     dose, randomized, placebo controlled, sequential-group. In both cohorts of Part A (Cohorts 1~     and 2), subjects will be randomized equally (1:1:1:1) to one of 4 treatment sequences.~     Within each period, allocation of active to placebo treatment will be 3:1.~      In all cohorts in Part B (Cohorts 3, 4 and 5) subjects will be randomized to GSK2982772 or~     placebo in a 3:1 ratio. If required, subjects in the additional cohorts in Part A (Cohort 6)~     and Part B (Cohort 7) will be randomized to GSK2982772 or placebo in a 1:1:1:1 and 3:1~     ratio, respectively. The study duration, including screening and follow-up, is not expected~     to exceed 105 days for any subject in the study.~   "
57661|NCT02302391|"~     Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric~     patients with long-term analgosedation will be performed. Especially, the chronologic~     sequence of the quantified plasma levels during sedation and during wake-up as well as the~     correlation to dose and sedation depth will be focused.~   "
57662|NCT02302378|"~     Spinal anesthesia is a common technique for providing anesthesia for knee joint replacement~     surgery. The investigators wish to demonstrate that using a lower approach to spinal~     anesthetic (Taylor's approach of L5-S1) causes less low blood pressure while still providing~     adequate anesthesia for knee joint replacement surgery than a higher approach (L3-L4).~   "
57663|NCT02302365|"~     This study is a multicenter, retrospective data collection of routine clinical use with the~     Spectra Optia® apheresis system for white blood cell depletion.~   "
57873|NCT02299622|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information Therefore, a big data of genome-clinical~     information is important.~   "
57664|NCT02302352|"~     Systemic sclerosis (SSc) is an autoimmune disease with unknown etiology, which affects~     especially the gastrointestinal tract, lungs, heart and kidneys. Immunological abnormalities~     characterized by innate and acquired immune disturbances are associated with the disease~     development. The present study aims to evaluate the efficacy and safety of probiotics in~     gastrointestinal symptoms, nutritional status and innate and acquired immune responses, by~     means of the evaluation of IgA, Treg and Th1, Th2, and Th17 T helper subtypes levels in~     patients with SSc. In addition the levels of CD4+ T helper Th1, Th2 and Th17 subtypes and~     Treg levels will be compared to a healthy control group.~   "
57665|NCT02302339|"~     This study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy~     or in combination with immunotherapies in patients with advanced melanoma.~   "
57666|NCT02302326|"~     The main objective of the present project is to evaluate the relevance of reticulum stress~     in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the~     underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities.~     Furthermore, the investigators will assess the potential of insulin sensitizers as a~     treatment to control endoplasmic reticulum stress markers in PCOS patients.~   "
57667|NCT02302313|"~     Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli~     of variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its~     safety. ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will~     be made on subjects at rest and in a state of hypnosis using the technique of remembering a~     pleasant memory and the ideo-sensory technique of protective glove.~      The average value of the ANI will be compared to the value of the EVN of pain intensity.~   "
57668|NCT02302300|"~     After cardiac surgery, many complications can arise, in particular at the cardiac and lung~     level and it is true especially as the patient is with comorbidity. A patient will be~     considered at risk of a cardiac surgery if risk factors are present in preoperative~     (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive~     ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency~     and the hypercapnic COPD exacerbations; its use is more and more envisaged in~     cardio-thoracic and abdominal surgery services.~      Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and~     a decrease of ventilation work. According to these observations, the preventive NIV could~     reduce the incidence of appearance of the lung and/or cardiac complications at the patients~     to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect~     to obtain a benefit with this particular population. If we meet our goal (a significant~     difference in terms of morbi-mortality with the preventive NIV versus classical care), we~     expect the systematisation of this procedure to all cardiac surgery high risk patients.~   "
57669|NCT02302287|"~     Food intake has a deep influence on gut microbiota composition and function, both in health~     and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is~     observed. Moreover, many toxic uremic molecules are microbial-derived and their accumulation~     promotes, in turn, disease progression.~      Investigators' hypothesis foresees a beneficial effect of nutritional treatments, able to~     restore gut microbiota balance, to lower microbial-derived uremic toxins and to improve~     clinical conditions in CKD patients.~      Mediterranean Diet (MD) is supposed to have beneficial effect on microbiota composition,~     while low-protein diet supplemented with ketoacids (KD) is used in CKD patients for the~     improvement of clinical conditions, but its effects on gut microbiota are currently unknown.~     Investigators' project aim is to verify the effects of MD and KD on: microbiota and~     metabolome composition, microbial-derived uremic toxins level and clinical conditions in a~     cohort of CKD patients.~   "
57670|NCT02302274|"~     The study aims to use flecainide infusion test as diagnostic test to unmask concealed~     Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients~     and its higher sensitivity when compared to procainamide infusion (the conventional drug~     used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order~     to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by~     flecainide iv.~   "
57671|NCT02302261|"~     Research has shown that pleth variability can be used to assess asthma severity in children~     with status asthmaticus. The investigators would like to use an FDA-cleared monitor (Masimo~     Radical 7) which measures Pleth Variability Index (PVI) to see if the degree of PVI can be~     used to help triage patients who present to the pediatric ED in status asthmaticus.~   "
57672|NCT02302248|"~     This study evaluates a web-based, crowdsourcing platform to promote cognitive reappraisal.~     Half of participants will be granted access to the crowdsourced reappraisal platform. The~     other half will be provided a web-based expressive writing platform. The investigators~     hypothesize that the crowdsourcing reappraisal platform will be more effective than the~     expressive writing platform in promoting positive psychological outcomes.~   "
57673|NCT02302235|"~     The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1~     ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy~     in patients with GBM in a prospective, randomized open label study.~   "
57674|NCT02302222|"~     The goal of this study is to evaluate the impact of Customizable in the management of~     extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional~     hernia repair and/or functional panniculectomy as compared to SOC dressing, and to~     significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC~     surgical incision dressing.~   "
57675|NCT02302209|"~     The purpose of the investigators proposed study is twofold: 1) To investigate the role of~     the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with~     schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate~     whether manipulation of this oxytocinergic system positively influences these family~     interactions.~   "
57676|NCT02302196|"~     The purpose of the study is to evaluate the safety and efficacy of breast reconstruction~     using Autologous Fat Grafting (AFG) for women post lumpectomy that have contour defects.~      The study hypothesis is that AFG has emerged as a less invasive alternative to breast~     reconstruction post mastectomy. AFG could be used to treat breast contour defects with much~     less invasive outpatient surgery, using the patient's own cells and tissues, which overall~     reduces risk.~   "
57677|NCT02302183|"~     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver~     automatically oxygen in infants and children admitted at hospital for hypoxemic acute~     respiratory distress.~      In healthy volunteers adults, FreeO2 system provided a better control of the oxygen~     saturation in function of designed target, reducing the desaturation time and hyperoxia. Our~     hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic~     acute respiratory distress. We think FreeO2 will provide a better control of the oxygen~     saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2~     could reduce the number of intervention by nurses.~   "
57678|NCT02302170|"~     Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that~     persistently colonizes the human stomach; more than half the human population is infected~     worldwide. H. pylori infection is a risk factor for the development of gastritis, peptic~     ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.~      The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed~     in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the~     oral recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good~     immunogenicity for health adults and children. To further explore the safety and~     immunogenicity profile of this vaccine, a phase Ⅲ clinical trial was conducted.~   "
57679|NCT02302157|"~     The purpose of this study is to evaluate the safety of 3 sequential escalating doses of~     AST-OPC1 administered at a single time-point between 14 and 30 days post injury,~     inclusively, to subjects with subacute cervical spinal cord injuries (SCI).~   "
57680|NCT02302144|"~     The primary objective of this study is to investigate the effects of a theoretically driven,~     highly challenging exercise program (balance and strengthening exercises) in reducing fall~     rate, improving balance and reducing fear of falling in persons with Parkinson's disease.~      In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be~     randomly assigned to either an early start (immediately following enrollment) or late start~     (3 months after enrollment) multifactorial exercise program which will meet 2 times per week~     for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening~     exercises which will be individualized depending on the ability of each participant. Fall~     rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be~     measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be~     enrolled for 6-7 months.~   "
57681|NCT02302131|"~     Multi-center, Observational Registry with Retrospective Enrollment and Prospective~     Follow-up.~      The aim of the registry is to document the feasibility and safety of implanting an Edwards~     SAPIEN XT transcatheter heart valve in the pulmonic position.~   "
57682|NCT02302118|"~     Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus~     extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)~   "
57683|NCT02302105|"~     Evidence to justify the use of the pelvic field is lacking for men with high risk localized~     prostate cancer. An additional randomized study is needed in men with a potential risk of~     nodal involvement to test the hypothesis that the use of the pelvic field contributed to the~     benefit observed in those studies.~      This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in~     patients with High risk, non metastatic Prostate cancer with a Lymph nodal >20% with Primary~     4 year Biochemical failure free survival and Secondary Disease free survival, overall~     survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two~     arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose~     prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2~     an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at~     rectal-prostate interface will receive 64 Gy/25#.~      All patients will receive hormone therapy starting at least 8 weeks prior to the beginning~     of radiotherapy. They will continue the hormone therapy and later for a total duration of~     2-3 years.~   "
57684|NCT02302092|"~     The purpose of this study is to determine if the antibiotic Flomoxef performs as well as~     Cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian~     adults.~   "
57685|NCT02302079|"~     The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with~     diabetic macular edema (DME). This study will evaluate the percent change from baseline in~     excess central subfield thickness (CST) in the study eye as assessed by spectral~     domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.~   "
57686|NCT02302066|"~     The purpose of this study is to assess the humoral immune responses to Takeda's Tetravalent~     Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy~     participants between 2 and <18 years of age living in dengue endemic countries.~   "
57687|NCT02302053|"~     The New Viviscal Professional Strength is an oral food supplement specifically designed to~     promote hair growth for women suffering from temporary thinning hair. It does not contain~     hormones, drugs or industry by-products. Viviscal has been marketed in Europe for over 15~     years.~      The purpose of this clinical research study is to evaluate certain physiological effects of~     Viviscal compared to placebo in forty (40) female subjects, ages 21-75 years of age with~     self-perceived thinning hair associated with poor diet, stress, hormonal influences or~     abnormal menstrual cycles when compared to using the placebo tablet.~   "
57688|NCT02302040|"~     The aims of this application are to develop and test AIM2ACT, a mobile health (mHealth)~     tool, delivered via smartphones, that fosters helpful caregiver support as early adolescents~     (ages 12-15) with persistent asthma develop and master asthma self-management behaviors. To~     facilitate helpful caregiver support, AIM2ACT uses mHealth technology to determine tailored~     intervention targets for each family. AIM2ACT then helps caregiver/adolescent dyads set~     asthma management goals by automatically guiding families through a structured process that~     includes the supportive behavioral management strategies of goal setting, contingency~     management, and problem solving communication. Skills-training videos for adolescents and~     caregivers provide guidance on how to complete each collaborative asthma management~     component.~      AIM2ACT will be developed through feedback from an advisory board of adolescent-caregiver~     dyads from the target user population and a pediatric pulmonologist. Following advisory~     board feedback, the investigators will conduct a pilot randomized controlled trial of~     AIM2ACT with 50 early adolescents with poorly controlled asthma, ages 12-15 years, and a~     caregiver. Families will be randomly assigned to receive AIM2ACT or a self-guided condition~     for a 4 month intervention period. Participants in the self-guided condition will be given~     general information on supportive behavioral management techniques they can use to target~     improvement in asthma self-management behaviors. Outcomes include whether participants~     prefer AIM2ACT or the self-guided condition. Additionally, AIM2ACT and the self-guided~     condition will be compared to see if there are differences in changes in family asthma~     management (primary outcome), lung function, asthma control, asthma-related quality of life,~     and self-efficacy for asthma management. Data will be collected before participants are~     assigned to AIM2ACT or the self-guided control, post-treatment, and 4 month follow-up time~     points.~   "
57689|NCT02302027|"~     Chronic headache is most often associated with drug abuse and medication overuse headache~     (MOH) is the main complication of migraine disease results in chronic daily headache. The~     first phase of treatment consists of drug withdrawal .~      The second phase of treatment (called consolidation) is to maintain the balance: treating~     headaches and reducing / stopping the drug use.~      The aim of this study is~        1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy~          (NOT) delivery by high flow concentrator~        2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through~          withdrawal period.~      It is a feasibility pilot study in chronic headache with or without medication-overuse. All~     patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and~     used to be called traditional management. The subsequent attacks will be treated with NOT~     from a high-flow concentrator~      Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of~     patients who accepted NOT during the withdrawal phase then to treat attacks.~      Secondary endpoints. Efficacy will be assessed by the percentage of patients having no~     chronic headaches two months after the start of withdrawal (less than 15 days of headache~     per month) and no longer in drug abuse (less than 10 days per month with drug intake).~      Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months~      Effective : 30 patients~   "
57690|NCT02302014|"~     Patients admitted as an unscheduled hospital admission with either a acute heart failure~     syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month~     mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is~     estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated~     to receive a holistic care intervention based around the creation of a detailed Future~     (anticipatory) Care Plan which is agreed with the patient and their family and which is~     shared with the Family Doctor and Emergency Services including ambulance teams. Primary~     endpoint is quality of life assessed by questionnaire.~   "
57691|NCT02302001|"~     ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study~     is designed to differentiate parameters of pain between randomized laterality using no touch~     technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of~     surgery but will receive a refund of a partial payment. Patients must undergo evaluation at~     consultation and surgical quote is provided.~   "
57692|NCT02301988|"~     This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II~     study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy~     versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa~     triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.~     The target sample size is 130.~   "
57693|NCT02301975|"~     This study is a randomized, double-blind, double-dummy, parallel group, multicenter,~     non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are~     currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist~     (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice~     daily [BD]), either via a fixed dose combination product or through separate inhalers. The~     study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed~     by a treatment period of 24 weeks, and a follow up contact period of one week. The total~     duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of~     the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI)~     100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via~     ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD~     (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM)~     via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol~     inhalation aerosol to use as needed to treat acute asthma symptoms. This study will~     determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50~     mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already~     adequately controlled on a twice-daily ICS/LABA.~      SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group~     of Companies.~   "
57694|NCT02301962|"~     This is an open label, multicenter, non-comparative, phase IV study of panitumumab~     monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral~     oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene~     homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the~     requirement of the Indian regulatory authority to characterize the safety and tolerability~     of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS~     metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated~     wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to~     achieve the target enrollment of 50 evaluable subjects who have received at least one dose~     of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously~     every 14 days until disease progression, intolerability, withdrawal of consent, or death.~     All subjects will be followed at 4 weeks and 8 weeks after the last administration of~     panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of~     the subject.~   "
57695|NCT02301949|"~     Background: Repeated episodes of bleeding from gastrointestinal vascular malformations~     refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.~      Methods: The investigators will perform a randomized, double blind, placebo controlled study~     of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to~     vascular malformation. Patients with failure of first course treatment of thalidomide will~     be randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide~     or placebo orally four times daily. All patients will be monitored for at least one year.~     The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥~     50% at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive~     fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit~     after treatment. Secondary outcomes include the participants dependent on blood transfusions~     and changes from baseline in transfused packed red cell units, bleeding episodes, and~     hemoglobin levels at 12 months. Statistical significance is defined at P < 0.05.~   "
57696|NCT02301936|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks~     in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease~     (SCD).~   "
57700|NCT02301884|"~     The investigators performed open-labeled pilot study which evaluates the efficacy and safety~     of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including~     Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are~     sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.~   "
57701|NCT02301871|"~     A long term habitual posture with abnormal loading of ligaments and muscles, leads to~     development of neck pain. 33 patients including 18 males and 15 females were selected and~     randomly allocated into three groups using sealed opaque envelope containing treatment~     allocation. Group A (n=11) received conventional treatment such as MHP (Moist Heat Pack),~     Static Stretching exercises, Cervical spine non-thrust mobilization, Cervical spine active~     ROM (Range of Motion) exercises and Postural exercises. Group B (n=11) received DNF training~     with conventional treatment. Group C (n=11) received Muscle Energy Technique (MET) in~     additional to conventional treatment. Primary outcome measure functional disabilities and~     secondary measure pain and ROM were recorded at baseline, 7th day and 14th day.One-way ANOVA~     was used for within group analysis. Repeated measure ANOVA followed by post hoc analysis was~     employed for between group comparisons. The results suggest that there was a significant~     improvement in mean change scores of Neck Disability Index (NDI), Visual Analogue Scale~     (VAS) and Range of Motion (ROM) .Both DNF training and MET have additional therapeutic~     effects over a standard care by reducing functional disabilities, pain and in improving ROM~     in mechanical neck pain patients.~   "
57702|NCT02301858|"~     The project aims to compare the histopathological and molecular characteristics of tumour~     tissue from metastases with similar analyses of the primary tumour in the lung, where it is~     available.~      The investigators will therefore perform analysis of blood samples if possible, to identify~     predictive markers in blood samples.~   "
57703|NCT02301845|"~     This is an interventional crossover study aimed at validating diatom shells as a marker for~     cuff leak and microaspiration in mechanically ventilated, critically ill patients.~   "
57704|NCT02301832|"~     This is a study intended to evaluate a non-invasive device that uses light to measure the~     amount of oxygen in the muscles of injured and non-injured legs in specific situations. The~     name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to~     collect the information necessary to understand the use of the NIRS monitoring system to~     diagnose and direct treatment decisions in case of complications sometimes experienced in~     traumatic tibia fracture, such as excessive swelling called acute compartment syndrome~     (ACS).~   "
57705|NCT02301819|"~     Eligible patients with severe cardiogenic shock will be randomized to one of the two arms:~     immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial~     ECMO will be implanted according to the local practice with flow settings to ensure~     sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group,~     all other diagnostic and therapeutic procedures will be done according to the current~     standard of care at the tertiary cardiovascular center, including other cardiovascular~     interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of~     other mechanical support devices including ECMO in the primary conservative group is allowed~     in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with~     the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and~     12 months.~   "
57706|NCT02301806|"~     To investigate whether single administration of sitaglitpin can restore acute endothelial~     dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells~     (EPCs) after oral glucose loading in patients with T2DM.~      To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by~     flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.~   "
57707|NCT02301793|"~     As part of mandatory on-going nursing education, the investigators have incorporated~     identical information into two distinct web-based learning formats - the traditional linear~     PowerPoint format (with voice-over) and a new interactive format developed with central~     nursing education.~      The investigators will cluster randomize nurses by floor to receive either the traditional~     education or the new interactive education, and evaluate the impact on administration of VTE~     prophylaxis doses administered by nurses before and after education. All nurses on a floor~     will receive the same educational format. If one method of education results in~     statistically significant improvement in VTE prophylaxis administration, the investigators~     will cross over to deliver the superior education format to all nurses who originally were~     given the less effective method.~   "
57708|NCT02301780|"~     Phase III two arm double-blinded randomised controlled trial to examine the effect of~     prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased~     risk for PET on the incidence and severity of the disease~   "
57709|NCT02301767|"~     The purpose of the study is to view what normal breast tissue looks like on an MRI and~     mammogram to help determine how it may affect the risk of developing breast cancer. The~     investigators will also compare the information collected from the questionnaire and medical~     records to help better understand how this may affect the risk of developing breast cancer.~     If a saliva or tissue sample is collected for future use, this information will enable us to~     study genetic risk factors as well.~   "
57710|NCT02301754|"~     INVAC-1 is intended to be used for the treatment of adult patients with advanced solid~     tumors unresponsive to currently available therapies, or for whom no standard therapy is~     available.~   "
57711|NCT02301741|"~     A fundamental clinical problem in individuals with chronic low back pain is the significant~     alteration in movement patterns that restrict lumbar spine motion. This is particularly true~     for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims~     of the current study are to use a whole body video game environment to 1) determine the~     effects of game play on lumbar spine flexion and expectations of pain and harm and 2)~     determine the effects of altered movement gain on lumbar spine flexion.~   "
57712|NCT02301728|"~     The purpose of this study is to determine whether the acetate, butyrate and propionate~     concentration in breast milk and to evaluate the possible correlation of these~     concentrations with maternal diet.~   "
57713|NCT02301715|"~     The purpose of this study is to determine the effect of intranasal administration of OT on~     behavior and discourse of insecure adolescents during a disagreement (stressful situation)~     with parents.~   "
57714|NCT02301702|"~     Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular~     pertussis vaccine (Tdap) is a potential strategy to protect young infants against pertussis~     before they are fully vaccinated because maternal antibodies may cross the placenta and~     passively protect her infant. The proposed study is a randomized, blinded, controlled,~     vaccine trial of maternal Tdap vaccination during the third trimester of pregnancy (Tdap~     vaccination at 27-36 weeks gestation). Pregnant women will be recruited from the prenatal~     care clinics at the Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La~     Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa. Enrolled women and their~     infants will be followed up until 7 months post-partum.~   "
57715|NCT02301689|"~     The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The~     study aims to understand the importance of diagnosis and treatment of sleep disordered~     breathing (SDB) on HF with the following questions:~      How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does~     SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment~     adherence of patients treated? Does SBD and its treatment affect the survival of heart~     failure patients?~   "
57716|NCT02301676|"~     The purposes of this study are to determine whether long-term postoperative cognitive~     dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect~     on the result about POCD.~   "
57717|NCT02301663|"~     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in~     heart) with symptoms of persistent chest pain, primarily impacts women. There are an~     estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent~     data from our research group suggests that coronary microvascular disease impairs the way~     the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort~     to better understand the pathophysiology of the disease. The investigators will recruit 30~     volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and~     10 age-match women for the group with microvascular disease). Subjects will undergo a series~     of stress maneuvers in conjunction with advanced cardiac magnetic resonance imaging.~   "
57718|NCT02301650|"~     Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV)~     transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many~     literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can~     significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment~     guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out:~     Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for~     blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late~     pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).~      The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In~     most of the related researches,the observation termination was 7-12 months after birth, and~     most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside~     (acid) analogues on children's development has not been reported in the literatures. The aim~     of this study is to make clear of the effect of nucleoside (acid) analogues used in late~     pregnancy on long-term impact of children's development.~      The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT~     or TDF during late pregnancy will be enrolled as study group, and eligible children whose~     mothers untreated will be enrolled as control group. The children's height, weight,~     nutritional status, developmental quotient and immune response to hepatitis B vaccine etc~     will be evaluated at baseline and at 3 years old. By comparing the children's development in~     different groups as well as in self-control of different ages, we will discuss the effect of~     Nucleoside (acid) analogues on children's long-term development.~   "
57719|NCT02301637|"~     The purpose of this clinical trial is to collect imaging data on embryos followed to~     blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.~   "
57720|NCT02301624|"~     To evaluate the safety and efficacy of eculizumab in the treatment of refractory gMG as an~     extension trial for the subjects who have participated in the ECU-MG-301 trial.~   "
57721|NCT02301611|"~     The majority of melanoma vaccines tested to date have been antigen-specific vaccines~     targeting melanoma-specific or associated antigens and utilizing a variety of delivery~     systems and immune-adjuvants. As opposed to testing an off the shelf vaccine that might be~     able to treat a subset of patients, our approach has been personalized to the patient and~     applicable to all patients. Our vaccine approach consists of harnessing the most potent~     antigen presenting cell in the body - the dendritic cell (DC) - together with the full~     repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II~     studies using an autologous DC-tumor cell fusion technique that has now been simplified into~     a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell~     wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC.~     These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID)~     monthly x 3 followed by boosters at 6, 12, and 18 months.~   "
57722|NCT02301598|"~     The purpose of the study is evaluating safety and clinical efficiency of full femtosecond~     laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus~     and corneal opacities~   "
57723|NCT02301585|"~     A randomized controlled clinical trial to evaluate whether a passive leg raising test to~     guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain.~     Patients will be treated according to an algorithm in which the indexed stroke volume~     (stroke volume related to body surface area) and mean arterial pressure will guide the~     timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be~     randomized to either an intervention group in which a passive leg raising test will be made~     prior to any decision for fluid administration or to a control group where this test is not~     performed and fluid administration is carried out according to standard of care at the~     department.~      Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.~   "
57724|NCT02301572|"~     Chart review.~   "
57780|NCT02300831|"~     The recent development of therapies targeting specific biomarkers mutations is changing the~     standards of care and prognosis of patients with advanced NSCLC, but very few data are~     currently available on those emerging biomarkers. In addition, the correlation of biomarkers~     with patients' clinical outcomes in a standard of care setting is poorly understood. This~     study aims to address that need.~   "
57725|NCT02301559|"~     Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is~     the most common gynecologic complaints in young women. According to the intensity of~     symptoms may impair daily living, work and leisure activities. Pilates brings the concept of~     moving the body for the recovery, maintenance and promotion of health through exercises that~     stimulate circulation, improving physical conditioning, flexibility and proper postural~     alignment, and promote improvement in the levels of body awareness, coordination and muscle~     control. In this sense, the objective is to investigate the effects of pilates in the~     symptomatology of primary dysmenorrhea. This is a study to be developed with students of~     Physical Therapy from the State University of Piauí-UESPI presenting with primary~     dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The~     students with the framework of dysmenorrhea that meet the inclusion criteria will be~     assessed for anthropometric parameters, pain, flexibility, indirect assessment of~     contraction of transversus abdominis and quality of life before and after the treatment~     protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.~   "
57726|NCT02301546|"~     The current study will test the effectiveness of a computerized cognitive (thinking)~     training program on improving thinking and memory in patients with mild cognitive~     impairment. The investigators will also examine how short term changes in thinking abilities~     (i.e., practice effects) can be related to improvement in thinking abilities after the~     cognitive training program.~   "
57727|NCT02301533|"~     Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection,~     and prevent HIV transmission by making people less infectious. Men who have sex with men~     (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can~     make ART adherence difficult. Our goal is to find out if an intervention involving provider~     counselling and support from an MSM peer will improve ART adherence and engagement in care~     among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM~     patient participants who reside in this area, identified through our outreach and testing~     programs in Mtwapa. Six providers and five peers who are trained for the intervention will~     also be consented in order to collect data on their feedback and help monitor the study. Our~     intervention consists of support from a trained peer with experience taking ART and enhanced~     counselling from providers that is aimed to motivate patients to improve and maintain their~     health. In an initial pilot test, we will implement our intervention with 10 MSM starting~     ART for the first time. After any needed revisions to research procedures and training, we~     will next conduct a small randomized controlled trial with 60 MSM patient participants to~     determine feasibility, acceptability, tolerability, and safety, and estimate an initial~     effect size for the adherence intervention. The 60 patient participants will be randomized~     to our intervention or to standard counselling care, and will be followed for 6 months to~     evaluate their ART adherence and retention in care. Providers and peers will give feedback~     at regular project meetings and in in-depth interviews after the pilot test and after the~     RCT. The work proposed for this project will be carried out over 2 years, from June 1, 2014~     through May 31, 2016.~   "
57728|NCT02301520|"~     Vitamin D deficiency is common worldwide, including in infants and children, and rickets~     remains a public health concern in many developing countries. The vitamin D status and~     prevalence of vitamin D deficiency in the Haitian population has not been studied. There is~     currently no approved point-of-care testing device for vitamin D deficiency. Iodine~     deficiency and resulting hypothyroidism is the leading cause of preventable~     neuro-developmental delay and cognitive impairment worldwide. Young infants and children are~     especially susceptible to sequelae of disruption in thyroid function given the dependence of~     the developing brain on sufficient levels of thyroid hormone. Perchlorate and thiocyanate~     have been described as potential environmental disrupters of thyroid function. Lead~     intoxication is a significant cause of disease throughout the world. Millions of people have~     suffered the effects of lead poisoning. Although most developed countries have taken drastic~     measures to limit the environmental lead levels, many countries in the developing world have~     not been able to address, or even assess, the problem.~      Our objectives are to study the following three components in 300 Haitian children between 9~     months and 6 years of age in three different geographical areas of Haiti: 1) Vitamin D~     status and prevalence of rickets, environmental factors associated with low vitamin D~     levels, and the accuracy and efficacy of a vitamin D point-of-care testing (POCT) device for~     the screening of vitamin D insufficiency. 2) Iodine status and thyroid function, and~     environmental disruptors such as perchlorate and thiocyanate as potential risk factors for~     abnormal thyroid function. 3) Lead levels and the extent of childhood lead poisoning.~   "
57729|NCT02301507|"~     There has been increasing use of technology in delivery of healthcare and increasing use of~     cellular phone and text messaging services to help with various healthcare related issues~     including but not limited to medication adherence and clinic attendance. Mobile phones~     technology has been used for healthcare delivery and prevention strategies such as smoking~     cessation. In the present era, cell phones have become part of daily life for most people~     even among those in lower economic groups. There have also been several studies looking at~     cell phone text messaging services to improve adherence to ART among HIV infected subjects~     but no studies have so far been done in HIV infected young women to help retention and~     adherence to care. The overall goal of this study is to evaluation of the impact of texting~     intervention to improve adherence to care and treatment in HIV infected young women.~      Study Hypothesis:~      Text message intervention will improve adherence to ART in HIV infected young women.~   "
57730|NCT02301494|"~     This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to~     determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and~     fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).~   "
57731|NCT02301481|"~     This prospective, randomized phase II study is designed to evaluate weather neoadjuvant~     chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and~     postoperative chemotherapy for locally advanced gastric adenocarcinoma.~   "
57732|NCT02301468|"~     A randomized controlled trial will be conducted to examine the effectiveness of DN versus IC~     on trigger points in the neck and shoulder region for reducing pain and improving~     functionality (primary outcome measures) and to investigate the effectiveness of DN versus~     IC for muscle strength, mobility and muscle tone (secondary outcome measures).~   "
57733|NCT02301455|"~     One of the most powerful predictors of stroke is hypertension, with estimates of~     approximately 33% of adults in the United States experiencing this condition.~      Hypertension is very prevalent in the emergency department (ED), but significantly~     undertreated. The overall goal of this project is to develop a text messaging intervention~     to improve hypertension care in the ED. This will first be done by testing the feasibility~     of identifying hypertensive patients in the ED, and the response rate to text messages.~   "
57734|NCT02301442|"~     Exercise has consistently yielded short-term, positive effects on health outcomes in people~     with multiple sclerosis (MS). However, these effects have not been maintained in the~     long-term. Behaviour change interventions aim to promote long-term positive lifestyle~     change. This study, namely, Step it Up will compare the effectiveness of an exercise plus~     Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus~     control education intervention on walking mobility among people with MS.~   "
57735|NCT02301429|"~     The purpose of this study is to evaluate the implant procedure and feasibility of a new lead~     developed to pace and sense the left chambers of the heart.~   "
57736|NCT02301416|"~     This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese~     individuals planning to undergo weight loss surgery. Individuals taking the medication~     before and after surgery will be compared to historical controls who had surgery without~     taking the medication.~   "
57737|NCT02301403|"~     This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit~     smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2)~     Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment~     have strong theoretical and empirical support from the investigators previous screening~     studies.~   "
57738|NCT02301390|"~     This study to is being conducted in India to determine the role of catheter-based ablation~     for ventricular tachycardia (VT) in post- heart attack patients who meet established~     guidelines for implantable cardiodefibrillator (ICD) implantation, but cannot afford it.~     These patients would be started on chronic Amiodarone therapy, which has been shown to be~     effective but can often lead to multiple side effects.~      Patients will therefore be randomized in an even proportion to either a) the control group,~     receiving chronic Amiodarone therapy, or the study group, undergoing catheter ablation of VT~     in addition to chronic Amiodarone therapy.~      This trial will serve as a representative model for the developing world.~   "
57739|NCT02301377|"~     The investigators know that adherence to medications in children with cystic fibrosis (CF)~     is poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients~     and their parents. Many of the investigators patients also report being motivated by the~     results of their lung function studies (PFTs) to stay adherent to their medications. In this~     study, the investigators would like to see if providing medication reminders and allowing~     patients to measure their lung function at home will lead to better adherence. This will be~     a pilot study to determine the feasibility of providing such as a device to children with~     CF.~   "
57740|NCT02301364|"~     The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also~     known as BKM120) has on lymphoma and the central nervous system.~   "
57741|NCT02301351|"~     The purpose of this study is to examine the effect of changes in cigarette package color and~     warning label features on smoking behaviors and beliefs about cigarette risks.~   "
57742|NCT02301338|"~     The purpose of this study is to assess the impact of more frequent follow-up (by~     videoconference) of these patients. Videoconference is a method of communication over a~     distance. In this method, the patient will hear the person's voice (like on the telephone)~     and will see that person over video.~      The study will compare more frequent follow-up of patients by videoconferencing to routine~     follow-up of patients. The investigators will compare each type of follow-up to see the~     effect on the number of times patients need to visit emergency rooms or need admission to~     hospitals. The study will also look at the difference between each type of follow-up on~     patients' quality of life and social support thirty days after hospital discharge.~      The study will also measure satisfaction and acceptability of this intervention among those~     who had follow-ups by videoconference.~   "
57743|NCT02301325|"~     Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and~     without transdermal nicotine on cigarettes smoked per day, nicotine exposure,~     discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence,~     biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use,~     cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue~     reactivity. The investigators will also consider differences between conditions in~     compliance with product use and the ability to abstain from smoking when provided a~     financial incentive for abstinence.~   "
57744|NCT02301312|"~     This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as~     a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will~     be enrolled and monitored at regular intervals for 18 months.~   "
57745|NCT02301299|"~     The investigators plan to develop and adapt a community-partnered intervention using~     community health promoters (Stroke Promoters) to deliver messaging regarding stroke~     symptom awareness and the need for calling 911 after stroke onset. The study investigators~     will implement this intervention in 2 large south side Chicago communities and measure the~     impact on symptom onset to hospital arrival times and EMS utilization using an interrupted~     time-series analysis.~   "
57746|NCT02301286|"~     The purpose of this study is to determine whether acetylsalicylic acidis effective on the~     recurrence and survival of colon cancer patients.~   "
57781|NCT02300818|"~     Glaucoma is among the leading causes for blindness in the western world. Elevated~     intraocular pressure (IOP) has been identified as the most important risk factor. However,~     some patients progress despite adequate IOP lowering while some subjects with elevated IOP~     never develop glaucoma. Other patients develop glaucoma although IOP measurements were~     always in the normal range. Therefore, other factors must be involved. In the last years,~     studies using MRI have been performed and evidence has accumulated that also changes in~     retrobulbar structures are present, in particular in the lateral geniculate nucleus and the~     visual cortex. However, these studies were limited by the low spatial resolution of the MRI~     instruments used.~   "
57747|NCT02301273|"~     Patients who have been admitted to Intensive Care Units (ICU) and are intubated and~     mechanically ventilated for longer than 48 hours have impaired physical, psychological and~     social health and well-being six to twelve months after discharge. The advocacy of intensive~     physiotherapy and mobilization early in the course of critical illness has been established.~     It is of great importance to study the long-term outcomes (physical function and quality of~     life) in intubated and ventilated patients who start exercising and ambulating mobilizing)~     as soon as possible during ICU stay because the most effective mode, intensity or frequency~     of exercise needs to be identified.~      The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and~     upright position in critically ill patients on prolonged invasive ventilation and to develop~     principles to guide physiotherapists in their clinical decision making in the ICU.~   "
57748|NCT02301260|"~     The purpose of this research study is to investigate the effectiveness of a computerized~     technique designed to improve processing speed (i.e. the amount of time it takes for a~     person's brain to process information) in a multiple sclerosis (MS) population. The study is~     designed to study how well this technique can help people with MS increase their processing~     speed and their ability to function better in everyday life. This treatment protocol has~     been studied extensively with older adults, showing improvements on standard laboratory~     measures of processing speed and performance of activities of daily living.~   "
57749|NCT02301247|"~     This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide~     Class I evidence in support of or in refute of the efficacy of the modified Story Memory~     Technique (mSMT) in persons with progressive MS, with outcome measured through three~     mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of~     global functioning (AGF) examining the impact of the treatment on daily activities, and (3)~     an optional functional magnetic resonance imaging (fMRI) scan.~   "
57750|NCT02301234|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as adjunctive therapy compared with placebo in participants with signs and~     symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current~     pain therapy.~   "
57751|NCT02301221|"~     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in~     adults with slow transit constipation.~   "
57752|NCT02301208|"~     This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin~     concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).~   "
57753|NCT02301195|"~     This study is being carried out to learn more about the effects of Therapeutic Horseback~     Riding (THR) for children and adolescents with an autism spectrum disorder (ASD). This~     treatment is very popular and horseback riding for children and adults with disabilities has~     been used as a form of therapy in the United States for over forty years. However, very~     little research has been done to find out whether or not THR is effective as a therapy for~     children with an ASD. This study is being done to see if THR will improve the agitation~     behaviors, coordination, and communication skills of children and adolescents with an ASD.~     This study is also being done to find out if the horse is necessary for children and~     adolescents with an ASD to improve.~   "
57754|NCT02301182|"~     A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the~     Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in~     Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads~     will be inserted into predrilled holes of the polyethylene rim for assessment of motion of~     the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by~     functional examinations as well as PROM assessment.~   "
57755|NCT02301169|"~     The purpose of this clinical trial conducted in patients suffering from chronic pain is to~     study the relationship between individual patients' profile and their analgesic response.~   "
57756|NCT02301156|"~     This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib~     compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL)~     patients with high-risk cytogenetic features. Half of the participants will receive~     ublituximab in combination with ibrutinib, while the other half will receive ibrutinib~     alone.~   "
57757|NCT02301143|"~     This clinical study is in subjects who are 18 years old or older with locally advanced~     pancreatic cancer who have not received prior treatment for their pancreatic cancer. The~     study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of~     treatment. Subjects who complete the treatment will choose, with their treating physicians,~     what additional treatment should be given: more nab-Paclitaxel plus gemcitabine,~     Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.~   "
57758|NCT02301130|"~     Mogamulizumab in Combination with MEDI4736 and Mogamulizumab in Combination with~     Tremelimumab in Subjects with Advanced Solid Tumors~   "
57759|NCT02301117|"~     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with~     advanced solid tumors and varying degrees of renal impairment.~   "
57760|NCT02301104|"~     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with~     advanced solid tumors and varying degrees of hepatic impairment.~   "
57761|NCT02301091|"~     The purpose of this study is to determine whether combined radiofrequency ablation and~     transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in~     patients with HCC and portal vein tumor thrombus.~   "
57762|NCT02301078|"~     This study will evaluate short-term pain and function associated with percutaneous needle~     aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in~     patients with Dupuytren's disease. Scores on outcome measures will be compared between~     groups to determine whether treatments differ in terms of hand function and pain during the~     early post-treatment period.~   "
57782|NCT02300805|"~     Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office~     hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women~     complaining of abnormal uterine bleeding.~      The safety of both procedures will be compared .~   "
57874|NCT02299609|"~     Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid~     for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6~     months.~   "
57763|NCT02301065|"~     Viral infections and reactivation during pediatric allogeneic hematopoietic stem cell~     transplantation (HSCT) are a common occurrence and significantly contribute to~     post-transplant morbidity and mortality. The risk is high due to prolonged periods of immune~     deficiency while awaiting immune reconstitution post-transplant. Current strategies to~     reduce complications from viral infections include prophylactic treatment, close monitoring~     for viral infections and prompt treatment at the first sign of symptoms or increasing viral~     load. However, the most definitive treatment for viral infections remains the host's~     cellular defenses. Improved understanding of the immune systems response to viral infections~     may lead to better treatment strategies.~      This study is being done to explore the relationships between T-cells and NK cells~     (infection fighting cells) and viral infections or reactivations in young allogeneic stem~     cell transplant patients. The investigators will be looking at how these cells react and~     function in young patients receiving allogeneic stem cell transplantation, as well as in~     healthy stem cell donors.~   "
57764|NCT02301052|"~     Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in~     management of symptomatic hemorrhoids in a double blind randomized placebo-control trial~   "
57765|NCT02301039|"~     The purpose of this study is to determine the efficacy of pembrolizumab in patients with~     advanced sarcomas.~   "
57766|NCT02301026|"~     The purpose of the study is to monitor initiated Diafer® therapy administered according to~     hospital practice and the product labeling in routine clinical practice in haemodialysis~     patients with Chronic Kidney Disease.~   "
57767|NCT02301013|"~     Main objective is to evaluate the relation between the increased urethral mobility and~     unsuccessful treatment after TVT and TOT operations.~      140 patients will be included in the research who are planned to have TVT and TOT operations~     with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for~     stress test will be included.~      All patients will be questioned for parity, body mass index, menopausal state, medical~     history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with~     transperineal sonography preoperatively. Passive mobility angle and active mobility~     angle will be measured.~      The relationship between passive mobility angle or active mobility angle and success of~     sling operations will be determined in this study.~   "
57768|NCT02301000|"~     This is a randomized controlled trial to compare the effect of a 10-day course of per oral~     Metronidazole versus a one-time rectal instillation of an anaerobically cultivated human~     intestinal microbiota for the treatment of a first occurrence of clostridium difficile~     infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize~     that the instillation of a healthy intestinal microbiota will be more effective in inducing~     a durable cure than Metronidazole for primary CDI.~   "
57769|NCT02300987|"~     To assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory~     teratoma with recent progression~   "
57770|NCT02300961|"~     This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based~     neurocognitive intervention program. It will secondarily be evaluated by performance on the~     neurocognitive testing post-transplant and change in performance in subsequent years.~   "
57771|NCT02300948|"~     There are three objectives in this study:~        1. To assess the serum folate pharmacokinetics of ingesting a single dose of~          PregVit-Folic5® versus a single dose of PregVit® (a multivitamin containing 1.1 mg~          folic acid)~        2. To assess the steady-state red blood cell (RBC) and serum folate concentrations~          achieved in non-pregnant, fertile women who supplement daily with PregVit-Folic5®~          versus PregVit®~        3. To assess the steady-state RBC and serum folate concentrations achieved before and~          during pregnancy in women planning a pregnancy or early in pregnancy (<6 weeks~          gestation) who supplement daily with PregVit-Folic5® versus PregVit®.~   "
57772|NCT02300935|"~     This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in~     patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in~     trials of patients with melanoma. However, the combination of these two drugs has not been~     studied. In this trial the investigators will determine the maximum dose of the drug~     combination to be administered to patients with advanced unresectable or metastatic melanoma~     and examine the safety profile of the drug combination.~   "
57773|NCT02300922|"~     Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted~     Radioimmunotherapy in metastatic colorectal cancer with ractionated injections of TF2 plus~     90Y-IMP288 (RITCOLON).~   "
57774|NCT02300909|"~     Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar~     laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.~   "
57775|NCT02300896|"~     The current model of care for the hospitalized elderly patients has been conditioned by many~     factors unrelated to the disease process that caused the hospitalization and usually worsen~     the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend~     most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or~     are walking). These patients have their functional and physiological reserve reduced which~     makes them more vulnerable to the effects of being bedridden. The consequences are at~     multiple levels emphasizing the functional loss or cognitive impairment, longer stays,~     mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased~     caloric intake, social isolation, poor quality of life and increased use of resources~     related to health. Exercise training can prevent functional and cognitive decline and modify~     even the posterior trajectory.~   "
57776|NCT02300883|"~     This is an observational prospective analysis of biological characteristics of malignant~     mesothelioma (MM) patients. Frozen and paraffin-embedded tumor specimens and pleural~     effusion of patients will be collected and than will be analyzed with the following~     analyses:~      1Purification of Tumour Associated Macrophages (TAM) and tumour cells from pleural~     effusions.~      2.Mass spectrometry analysis of TAMs and tumor cells 3.Co focal microscopy analysis of~     macrophages, tumour cells and specimens derived from patients.~   "
57777|NCT02300870|"~     The primary objective of this proposal is to show the efficacy of contrast enhanced~     ultrasonography in detecting heart transplant rejection in humans. The secondary objective~     is to demonstrate the efficacy of this technique in generating data which allow for the~     assessment of short and long term outcomes.~   "
57778|NCT02300857|"~     This study will evaluate the effect of macronutrient diets on brain activity in homeostatic~     and mesolimbic reward regions.~   "
57783|NCT02300792|"~     This study is a randomized, placebo controlled, double-blinded clinical trial, which~     included 50 children with hepatitis A. They were of both sexes and their age ranged from 2~     to 18 years. The patients were randomly assigned into one of two groups; each consisted of~     25 children. Each patient in the intervention group (group 1) took oral honey in a dose of 5~     ml/kg/day (with a maximum dose of 150 ml/day) for four weeks, whereas patients of the~     placebo group (group 2) took placebo in the form of molasses. The main outcome measure was~     the recovery time defined as the number of days from the start of the intervention to~     subsidence of symptoms and signs of hepatitis and return of liver transaminases to their~     normal levels.~   "
57784|NCT02300779|"~     This trial will compare the efficacy of to 2 different sets of dietary recommendations to be~     followed before colon cleansing for colonoscopy in diabetic patients.~   "
57785|NCT02300766|"~     The purpose of this study is to determine why up to 25% of the pediatric patients who have~     surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS).~     Furthermore the purpose is to explore the clinical course and the best treatment of the~     syndrome.~   "
57786|NCT02300753|"~     Expanded access Protocol to treat LHON subjects with EPI743~   "
57787|NCT02300740|"~     Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so~     far not analyzed.~   "
57788|NCT02300727|"~     Oral mucositis is a common side effect from cancer treatment. Patients receiving~     chemotherapy and radiotherapy can get very painful sores in their mouth that compromise~     nutrition and oral hygiene as well as increase risk for infection, and can last for weeks.~     Currently, the only treatment for mucositis is oral hygiene to try to support recovery.~      Curcumin (also known as Turmeric) is a frequently-used spice in India and Southeast Asia.~     Studies in cells and animals have shown that it can reduce the amount of bacteria and can~     prevent inflammation.~      In this study, the investigators want to learn if a mouthwash made with curcumin is safe for~     people to use and if it can help their mucositis.~   "
57789|NCT02300714|"~     A comparison of anterioposterior versus oblique view approach method for~     fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate~     differences on total radiation time and technical feasibility between anterioposterior and~     oblique view approach method.~   "
57790|NCT02300701|"~     To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.~   "
57791|NCT02300688|"~     After administration of besifovir preparations different from each other to healthy~     subjects, the investigators evaluate equivalence of bioavailability of LB80331.~   "
57792|NCT02300675|"~     The purpose of this study is to evaluate the feasibility and the effectiveness of a patient~     education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or~     aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists,~     patient education and medical oncologists.~   "
57793|NCT02300662|"~     A single blind randomized controlled trial (the MoVe ICU study) will be conducted to~     evaluate the effects on critical patients on invasive mechanical ventilation of early~     mobilization with a cycle ergometer.~   "
57794|NCT02300649|"~     Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an~     adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular~     effect through activation of receptors in central and peripheral nervous system. The classic~     cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase~     in blood pressure followed by long-lasting decrease in BP and HR. There were several reports~     about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects~     on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine~     as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.~   "
57795|NCT02300636|"~     This study investigates different resistive co-contraction trainings effect on knee strength~     recovery after ACL reconstruction. Participants will be divided into three groups. Group 1~     will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic~     chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction~     training in open kinetic chain position and Group 3 (control group) will only receive~     standard ACL rehabilitation.~   "
57796|NCT02300623|"~     Interventions during primary HIV infection (PHI) can modify the immune control and the~     clinical evolution during the chronic phase. Although several studies suggest the benefit of~     antiretroviral treatment (ART) during PHI, indication of ART is still not universally~     recommended. The investigators randomized patients with PHI, with a favourable immunological~     profile and well controlled on ART, to undergone structured treatment interruptions alone or~     with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV~     replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses~     and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up,~     up to nine years since final ART stop.~   "
57797|NCT02300610|"~     The main purpose of this study is to find out the dose of enzalutamide that can be safely~     given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers~     also want to find out the side effects of these drugs when given together. This study will~     also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine~     and cisplatin.~   "
57798|NCT02300597|"~     Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered~     internet-based support and coaching during eight weeks (chat and e-mail). Data is collected~     before and after the intervention and six months after end of treatment using self-report~     questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive~     and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the~     next of kin. After treatment the young people are interviewed regarding the quality of the~     intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is~     offered treatment as usual and is assessed at the same time points as the intervention~     group. The individuals are not randomized due to difficulties to recruit if the individuals~     do not know group assignment in advance.~   "
57799|NCT02300584|"~     The purpose of this study is to refine and test the web-based delivery of a well-established~     in-person group program that provides information and education to informal caregivers~     (family and friends) of persons with Alzheimer's disease (or related illnesses).~   "
57801|NCT02300558|"~     This study will evaluate the effect of eleclazine on shortening of the corrected QT interval~     (QTc), safety, and tolerability in adults with type 3 long QT syndrome (LQT3). During the~     single-blind treatment period (24 weeks), participants will receive eleclazine and/or~     eleclazine placebo. Following the single-blind treatment period, participants who have not~     permanently discontinued study drug will be eligible, at the discretion of the investigator,~     to continue receiving eleclazine during an open-label extension phase.~   "
57802|NCT02300545|"~     Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue~     sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that~     are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is~     well tolerated with minimal side effects, the investigators propose a phase II study to~     evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic~     disease who are not candidates for cytotoxic chemotherapy.~   "
57803|NCT02300532|"~     Post-marketing surveillance to investigate the clinical safety and effectiveness in patients~     of all implantation of Gliadel with malignant glioma in the actual medical setting.~   "
57804|NCT02300519|"~     Personalized therapy in haemophilia has not been reached yet. Treatment is substitutive and~     its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX~     (for haemophilia B). The bleeding severity is not only related to the factor deficiency but~     also to levels of other coagulation factors (e.g. factor X, II, AT or TFPI). It's necessary~     to take them into account in order to individualize treatments; and Thrombin Generation~     Assay (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because~     it measures the result of the coagulation cascade. TGA on Platelet Rich Plasma (PRP) is even~     closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet~     influence is represented. It has already been shown (at least in PPP) that the bleeding~     tendency in haemophilic patients is usually well correlated to TG. Some TG parameters are~     used to characterize the individual coagulation phenotype, the most important being the~     Endogenous Thrombin Potential (ETP) and the Lag Time (LT). A hemorrhagic profile usually~     provides a longer lag time and / or a lower ETP. However, only few studies tried to~     determine the influence of each coagulation factor and inhibitor on TG. They were done on~     Platelet Poor Plasma (PPP) or on lyophilized plasma. So the relation between coagulation~     factors and the different TG parameters remains to be determined, especially in the~     haemophilic case. It is possible, experimentally, to find the optimal dose of the factor to~     be added by measuring TG in samples with different factor VIII or IX concentrations, but~     this method would be time consuming and expensive, especially because it should be done for~     each haemophilic patient. A better way consists in using TG numerical models. For a set of~     initial factor levels they simulate the TG and its associated parameters. It is now~     essential to validate the existing models, especially in haemophilic cases, in order to see~     whether they are reliable and can be used in clinical practice afterwards.The objective of~     this study is to validate thrombin generation numerical models which could predict the~     factor VIII or IX activity correction to reach a thrombin generation sufficient to avoid~     bleeding. A comparison between the TG observed in haemophilic patients and the TG predicted~     by the models is needed to validate the models. In order to define a 'safe' TG i.e.~     sufficient to avoid bleeding, normal ranges of TG parameters have to be measured.~   "
57805|NCT02300506|"~     The objective of this study is to determine the survival status of patients enrolled in~     study GLI01S (all-case observational study).~   "
57806|NCT02300493|"~     Examining the effect of daily self-weighing on the ability of student to prevent from~     gaining weight during their four years at Cornell.~   "
57807|NCT02300480|"~     Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an~     incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC~     remains unknown and visceral hyperalgesia and central sensitization have been suggested to~     be part of the pathophysiology. So the purpose of this study is to determine whether Calot's~     Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is~     superior to PCIA in reducing the incidence of chronic pain after LC.~   "
57808|NCT02300467|"~     The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety,~     tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516~     Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid~     tumors.~   "
57809|NCT02300454|"~     Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with~     in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB~     dilatation impacts on clinical and angiographic outcomes or not is unknown. Lacrosse®~     Non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements~     which are attached to proximal and distal balloon edges. NSE is developed to incise~     neointimal tissue and avoid balloon slippage without vitiating balloon derivability and~     crossability. We investigated angiographic and clinical outcomes following normal~     non-compliant balloon or NSE dilatation prior to DCB dilatation in ISR lesions.This study is~     a single blinded, multicenter, randomized trial. Total 200 patients with ISR are randomly~     assigned to treat with non-compliant balloon or NSE before DCB dilatation. Optical coherence~     tomographic (OCT) analysis are performed before pre-dilatation and after DCB dilatation~     Follow-up angiography analysis are planned at 8 months in all patients. Clinical follow-up~     is planned at 8 and 24 months.Primary endpoint is angiographic in-segment late loss at 8~     months.~   "
57810|NCT02300441|"~     A prospective cohort pilot study of non-cardiac patients to determine the feasibility of~     recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to~     3 days.~   "
57811|NCT02300428|"~     Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with~     children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million~     prescriptions for oral iron are filled in England alone (NHS Information Centre data).~     However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients~     (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron~     salts constitute the vast majority of currently prescribed oral iron because these are cheap~     and well absorbed. However, they are also poorly tolerated and thus, we believe, are~     expensive to the NHS.~      Funded by the Medical Research Council, we have developed an alternative oral iron~     supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy~     for IDA with minimal side-effects.~      In the study proposed here we aim to assess the total health cost associated with current~     oral iron supplements and, hence, define the clinical unmet need for alternative treatments.~     We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern~     of prescribing to oral iron in primary care in the general population and (ii) develop a~     health economics model in pre-menopausal women. These data will provide evidence for the~     total health system costs associated with current oral iron treatment. Furthermore, this~     study will provide data from which the cost-effectiveness and total health system costs of~     alternative effective and treatments with minimal side-effects could be estimated.~   "
57875|NCT02299596|"~     This study will compare the outcome after surgery between a group of patients that receives~     instructions for prehabilitation training and one group that received standard treatment.~   "
57812|NCT02300415|"~     Severe sepsis and sepsis shock are common in emergency department, with a high mortality~     rate. The potential severity of this disease impose a diagnosis as early as possible to~     start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important~     support for the emergency physician. However, comparison of sensitivity and specificity for~     new biomarkers, like presepsine, suggests that they can be more efficient in this area.~      In this single-center, prospective, non-interventional study, we propose to compare the~     sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic~     shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of~     lactate for the diagnosis of severe sepsis.~   "
57813|NCT02300402|"~     The present study aims to further optimize a whole-body Diffusion‐Weighted Magnetic~     Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla~     MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body~     parametric image analysis algorithm, and to determine the added value of whole-body DWI to~     Fluorodeoxyglucose-PET for the management of lymphoma patients.~   "
57814|NCT02300389|"~     The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost~     Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients~     combined with Androgen Deprivation Therapy.~   "
57815|NCT02300376|"~     Diagnosis of patients with renal insufficiency and recommendations for medical treatment of~     patients who suffer from chronic renal failure are based on the different stages of~     Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas~     are unreliable in many clinical situations (old people, obese patients…). Methods for~     measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference~     tracers. Renal clearance of Inulin is the gold standard. However, using these methods is~     restricted to specialized services because it is long and expensive.~      There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR.~     Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a~     tracer comes from its exclusive elimination by glomerular filtration.~      Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for~     every included patient during a hospital day care (First visit V1). For transplanted~     patients, plasma clearance of Calcium edetate de sodium will be repeated within one week~     (more or less 48hours) during annual medical check-up of renal transplantation (Second visit~     V2).~   "
57816|NCT02300363|"~     This study will be conducted as a single-center, open-label, 2-period, single-sequence,~     drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg~     tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy~     male and female subjects.~   "
57817|NCT02300350|"~     This study will be conducted as a single-center, open-label, 2-period, single-sequence,~     drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg~     administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 ×~     0.25-mg tablets) in healthy male and female subjects.~   "
57818|NCT02300337|"~     Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical~     ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the~     tightness of LT between the filling volume specified by the manufacturer (connectors are~     color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of~     the leakage occurs in ml / kg body weight.~   "
57819|NCT02300324|"~     There is current evidence that suggests eating cruciferous vegetables like broccoli,~     cauliflower, cabbage is beneficial to our health as they contain compounds which are thought~     to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous~     vegetables are able to deliver in our body a group of compounds called isothiocyanates~     (ITCs) that are thought to be responsible of their health-promoting effects. Sulforaphane~     (SF) from broccoli is one of the most studied ITCs and its anticancer properties have been~     extensively investigated in in vitro and in vivo models.~      The investigators propose to undertake an intervention study to measure the bioavailability~     of SF from the soups used in another intervention study called ESCAPE. The investigators~     would like to investigate the rate and extent to which SF reaches the systemic circulation~     and is excreted in urine by measuring SF and its metabolites in plasma and urine samples~     collected from apparently healthy participants after consumption of the three types of~     broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and~     two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver~     different levels of SF.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
57820|NCT02300311|"~     To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo~     in patients with acute low back pain. To investigate the safety and tolerability of repeated~     use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).~   "
57821|NCT02300298|"~     To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75~     mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area~     (BSA) <1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung~     cancer (NSCLC) after failure of first line platinum- based chemotherapy~   "
57822|NCT02300285|"~     Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in~     infants with low blood glucose to improve how we care for these infants. To do this we plan~     on monitoring blood glucose levels with CGMs (instead of only with intermittent~     bloodsampling) in late-preterm and term infants admitted to the NICU who have had~     hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us~     to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a~     CGM group where the CGM information is made available to the NICU team and a Standard of~     Care group where the CGM information will only be available to the research team. However,~     if infants in the Standard of Care group are noted to have three unrecognized severe low~     blood glucose levels then the research team will inform the NICU team that this has~     occurred.~   "
57823|NCT02300272|"~     This is a single-center, observational study design. Enrolled participants will be~     typically, healthy older adults. Participants will complete daily computerized measures, in~     addition to continuously wearing an Actiwatch device. The study period will last 2 weeks.~     The objectives of the study are to examine the impact of sleep, pain, and circadian rhythm~     on practice-related learning in older adults at their preferred versus nonpreferred times of~     day.~   "
57824|NCT02300259|"~     The first purpose of this study is to evaluate the effect of itraconazole (and possibly~     diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get~     rid of it.~      The second purpose of the study is to evaluate the effect of LY2623091 on the amount of~     simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get~     rid of it.~      The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and~     diltiazem or tadalafil will be evaluated.~      There will be three groups of participants in this study. Results from Groups 1 and 2 will~     be analyzed during the study to determine whether to enroll participants in Group 3 or 4.~     The study is expected to last up to 40 days from the first dose to follow-up (inclusive).~     Screening may occur up to 28 days prior to enrollment.~   "
57825|NCT02300246|"~     The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with~     biomechanical processing simplified and without the need for handling blood biochemistry.~     Some studies have shown the potential of PRF in release growth factors assisting and~     accelerating the regeneration of soft tissues, however with contradictory results regarding~     the hard tissues. The aim of this study will be to evaluate through clinical analyzes,~     histomorphometric and micro-computed tomographic images, the dimensional changes, the~     quantity and the quality of the tissues formed socket after extractions that receive~     membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction~     and the other 15 (control group) received no biomaterial (spontaneous healing).~   "
57826|NCT02300233|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for~     26 weeks in patients with Hypertriglyceridemia~   "
57827|NCT02300220|"~     This study investigates the effects of targeted re-treatment of patients who do not recover~     from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the~     other half will receive a placebo.~   "
57828|NCT02300207|"~     To investigate the changes of cardiovascular function during short-term simulated~     weightlessness after electroacupuncture (EA) treatment．~   "
57829|NCT02300194|"~     Introduction:~      Opioids, such as morphine, act at receptors in the central nervous system, but many studies~     have suggested direct action peripherally on opioid receptors in sensory neurons terminals,~     melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs~     inflammatory processes.~      Hypothesis:~      Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure,~     decreases pain in children.~      Method:~      A randomised double-blind parallel study to evaluate the effect of topical application of a~     0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be~     included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be~     applied 30 minutes before the procedure and the first day every 4 hours. General basic~     sedation and systemic analgesia will give for all the patients. Efficacy of treatment will~     be measured with Face, Legs, Activity, Cry, Consolability scale (FLACC scale).~   "
57830|NCT02300181|"~     The purpose of the present study is to evaluate the effect of the extract of the flour~     fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects~     with prediabetes.~   "
57831|NCT02300168|"~     The aim of the current observational study is to better assess the relationships between~     neuromuscular blockade and multiple surgical outcomes in patients undergoing elective~     laparoscopic bariatric surgery.~   "
57832|NCT02300155|"~     The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal~     vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a~     variety of conditions.~   "
57833|NCT02300142|"~     This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be~     randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.~      Objectives:~        -  To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6~          different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:~             -  Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)~             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last~               dose of vaccine~             -  Lesion rate (percent of days with genital lesions present) during the~               post-vaccination follow-up period~             -  Antiviral use.~        -  To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.~   "
57834|NCT02300129|"~     Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of~     the flush of rosacea.~   "
57835|NCT02300116|"~     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor.~   "
57836|NCT02300103|"~     This study will evaluate the efficacy, safety and tolerability of treatment with sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) with ribavirin (RBV) for 24 weeks in adults with chronic~     hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did~     not achieve sustained virologic response (SVR).~   "
57837|NCT02300090|"~     A real world study to determine the effectiveness of a patient support service to aid COPD~     patients in their self management.~   "
57838|NCT02300077|"~     The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult~     pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage~     by providing more stable plasma concentrations and long-lasting pain relief. Methadone~     perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients~     is well characterized. There is, however, no information on methadone use in an ambulatory~     surgery setting and outpatient procedures. This pilot investigation will determine~     effectiveness of intraoperative methadone in reducing postoperative opioid consumption and~     providing improved pain relief in patients undergoing moderately painful, ambulatory~     surgical procedures.~   "
57839|NCT02300064|"~     The purpose of this study is to find out more about the effects of chronic obstructive~     pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and~     during exercise.~   "
57840|NCT02300051|"~     The purpose of this study is compare three interventions (short-term psychodynamic~     psychotherapeutic group and relapse prevention group therapy vs. treatment as usual, namely,~     psychiatric follow up including prescription of medication vs. both interventions combined)~     to individuals presenting compulsive sexual behavior.~   "
70522|NCT02134288|"~     Currently looking for individuals that have received a kidney transplant, are experiencing~     delayed graft function (DGF), and meet the criteria for study participation.~   "
57841|NCT02300038|"~     Background Subanesthetics concentrations of lidocaine are able to produce a differential~     block of the ectopic discharges, but not propagation of impulses, suppressing differentially~     the associated neuropathic pain symptoms. The aim of this study was to investigate the~     differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine~     0.1% on several neuroma related pain modalities.~      Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve~     injury participated in this randomized, double-blind experiment. The patterns of sensory~     changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to~     the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed~     using a visual analogue scale (VAS), quantitative and qualitative sensory testing.~   "
57842|NCT02300025|"~     This study is an open-label, multi-center, single-dose, parallel group study to determine~     the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to~     fasted male and female adult subjects with varying degrees of hepatic function. The study~     will be conducted based on the Child-Pugh classification of hepatic impairment. The~     anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers~     with varying degrees of hepatic function and up to 12 healthy control volunteers.~   "
57843|NCT02300012|"~     Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.~      Performance Based Investigations (PBIs) can be used to evaluate and select correct~     approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers~     in other conditions are sensitive in distinguishing between disease state severities, type~     of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs,~     these are not widely used possibly owing to their focus postoperatively where benefits are~     less worthwhile.~      This study aims to investigate novel biomarkers as performance based investigations (PBIs)~     to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients.~     The objectives are to identify whether biomarkers, collected before and after operations,~     can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to~     predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help~     further understand ACL injuries.~   "
57844|NCT02299999|"~     Open label multicentric phase II randomized trial, using high throughput genome analysis as~     a therapeutic decision tool, which aims at comparing a targeted treatment administered~     according to the identified molecular anomalies of the tumor with maintenance chemotherapy~     (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients~     without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).~   "
57845|NCT02299986|"~     'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by~     Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical~     ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and~     colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a~     day in a small cohort of mechanically ventilated patients. This is a longitudinal,~     single-centre, observational cohort study to examine the long-term effects of invasive~     mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.~   "
57846|NCT02299973|"~     Intestinal microbiota dysbiosis is thought to play an important role in the complex~     pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS~     and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been~     shown to be an effective means of correcting this imbalance in the gut microbiota,~     especially in patients with recurrent Clostridium difficile infections where it has become a~     preferred treatment strategy.~      In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted~     therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and~     abdominal bloating was seen three months after transplantation.~      In this study the effects of FMT on patients with IBS without constipation and bloating will~     be investigated in a double blind, placebo controlled RCT.~   "
57847|NCT02299960|"~     The main purpose of this study is to analyse test-retest-reliability of functional~     quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with~     heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial~     hypertension and diabetic nephropathy. In the same group, test-retest-reliability of~     circulating endothelial cells as well as test-retest reliability of non invasive cardiac~     output Monitoring will be observed and analysed.~   "
57848|NCT02299947|"~     The purpose of this study is to answer the following question: Leads a primary coagulation~     corrected with a single dose of fibrinogen concentrate after ascending aorta-arc~     reconstruction to a decrease in the number of allogenic blood transfusions, compared to~     placebo?~   "
57849|NCT02299934|"~     This study plans to learn more about the two Magnetic Resonance Angiography (MRA)~     techniques.~   "
57850|NCT02299921|"~     This study plans to learn more about people who are sick in the hospital with a lung~     infection, or respiratory failure. Respiratory failure, or severe lung failure, is a~     life-threatening disease. When it happens, the lungs have trouble carrying out their normal~     function of getting oxygen into the blood, and removing carbon dioxide from the body.~     Investigators are conducting this study to see what drinking too much alcohol, using tobacco~     products, or using drugs (both legal and illegal) may do to lung infections and respiratory~     failure.~      Subjects are asked to be in this research study because they are thought to have a lung~     infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been~     linked to lung infections, respiratory failure, and even death, but the reasons for this~     aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more~     at risk for lung infections, and for severe complications due to lung infection. Subject~     participation is important whether or not you use alcohol and or drugs.~   "
57887|NCT02299440|"~     The primary objective of this study is to assess the efficacy of ketamine versus a placebo~     for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation,~     measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.~   "
58106|NCT02296580|"~     This feasibility study will assess the effects of the Nativis Voyager therapy in patients~     with recurrent GBM who have either failed standard of care or are intolerant to therapy. The~     study will enroll and treat up to 64 subjects of which 32 will be treated with the Voyager~     therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent~     chemotherapy. Safety and clinical utility will be evaluated.~   "
57851|NCT02299908|"~     Acute postoperative pain is one of the most important centers of therapeutic attention in~     postoperative phase of any procedure. It is a complex entity that requires a multiple~     intervention to be treated and, depending on the intervened surgical site, it has different~     approaches.~      Despite attempts to reduce postoperative pain by implementing management protocols, rates of~     pain prevalence from moderate acute to severe pain are still reported as high as 50% in the~     first 24 postoperative hours. Among the surgeries that report greater intensity of~     postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been~     described for the management of acute pain in this surgery postoperative, among which PAT~     blocking has shown to be beneficial in some studies. However, some reports question its~     usefulness but with the emergence of ultrasound-guided techniques for its realization,~     interest in this blockage has grown back.~      This study aims to demonstrate the utility of the PAT blocking in the management of acute~     pain of pre-peritoneal inguinal herniorrhaphy with mesh.~   "
57852|NCT02299895|"~     Background:~      In the field of health promotion, the 'setting approach' has gained increased attention over~     the last decades. Following this approach, organizations and governments are urged to invest~     in health and health promotion. However, the dissatisfaction with the broad definition of~     the term 'setting' has grown. As many health promotion programs are carried out in~     organizational settings, substantial work has been done on how to acknowledge organizational~     factors in designing and implementing health promotion programs. Organizational settings~     differ from others because they can also address their clients as beneficiaries of health~     promotion programs, also known as 'client-oriented health promotion'. Among the most~     prominent organizational settings for health promotion are schools and hospitals, and more~     recently, long-term care (LTC-) facilities. However, dissemination and implementation of~     client-oriented health promotion in organizational settings seem to be very challenging.~     Most approaches dealing with barriers to health promotion implementation in schools,~     hospitals, and LTC-facilities rarely reflect the specific organizational characteristics.~     This negligence constitutes both, a research gap in the setting approach and in the design~     of health promotion practice. Hence, the aim of this study is to explore professionals'~     (teachers', health professionals', care aids') views and attitudes that influence the~     implementation of client-oriented health promotion programs between schools, hospitals, and~     LTC-facilities in Austria.~      Methods:~      With that aim in mind, the investigators chose a comparative qualitative design.~     Semi-structured interviews will be conducted with 90 professionals (30 in schools, 30 in~     hospitals, and 30 in LTC-facilities). In addition, non-participant observations as well as~     an extensive document analysis in each setting will be undertaken. The data will be analyzed~     by thematic analysis. Comparisons within as well as between the organizational settings will~     be conducted using selected categories.~      Discussion:~      To date, this study is the first of its kind that compares results of individual~     semi-structured interviews between different organizational settings. This study~     investigates professionals' views and attitudes on facilitating and hindering factors of~     implementing client-oriented health promotion programs and thus will provide a solid basis~     for future research activities and evaluation studies in the field of health promotion~     implementation.~   "
57853|NCT02299882|"~     Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical~     infection rates.~   "
57854|NCT02299869|"~     Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs.~     Competitor)of Color Soft Contact Lenses~   "
57855|NCT02299856|"~     Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection~     of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of~     the Lake Louise Criteria (two of three criteria have to be positive in order to establish~     the diagnosis). Although these criteria are accepted and widely used in clinical routine,~     several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping,~     extracellular volume fraction (ECV) and myocardial strain analysis have the potential to~     complement or even replace some of the Lake Louise Criteria and further enhance the~     diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The~     aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR~     protocol in patients with acute myocarditis.~   "
57856|NCT02299843|"~     Currently，the ALPPS (associating liver partition with portal vein ligation for staged~     hepatectomy) procedure which enables the rapid growth of the future liver remnant and~     extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma~     becomes a research hot spot. However, the procedure has a high morbidity and mortality~     rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a~     coagulation band in stage I will reduce the incidence of complications（bile leakage,~     abdominal infection,hemorrhage e.t.) The investigators named this technique as~     Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy~     （RALPPS）.Investigators hypothesized that the RALPPS might result in lower morbidity and~     mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective~     Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver~     partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.~   "
57857|NCT02299830|"~     The purpose of this study is to evaluate the efficacy and safety of four interventional~     pulmonology techniques for the treatment of malignant central airway stricture.~      The four techniques are：~        -  cryotherapy~        -  argon plasma coagulation~        -  stent~        -  snare~   "
57858|NCT02299817|"~     The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis~     around uncemented acetabular implants used in total hip arthroplasty. Patients included in~     the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a~     total of 6 doses with start on day one and every 6 months with last treatment at 30 months.~     The primary endpoint will be the change in volume of the osteolytic lesion over 3 years~     measured (measured with 3D-CT in cm³).~   "
57859|NCT02299804|"~     A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120~     patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to~     evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the~     effective dosage for phase IIb clinical study, to study the safety of Levophencynonate~     Hydrochloric.~   "
57860|NCT02299791|"~     The purpose of the ALL Study is to determine the effectiveness of the dissemination of the~     ALL intervention from an integrated care setting into Community Health Centers (CHCs) by~     measuring changes in diabetes mellitus (DM) population prescription rates for the~     medications, using a pre-post comparison within clinics and a staggered, randomized~     implementation across clinics.~   "
57861|NCT02299778|"~     The purpose of this study is to determine whether folate produced by bacteria that live in~     our colon can be absorbed in human colon using a stable isotope method. This study would~     lead a better understanding of the bioavailability of colonic bacterially-synthesized folate~     and its quantitative contribution to whole body folate homeostasis.~   "
57916|NCT02299063|"~     The investigators hypothesize that in addition to a known sympatholytic effect,~     intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and~     structure attenuating ischaemia-reperfusion and end-organ injury for children with non~     cyanotic congenital heart defects having corrective heart surgery.~   "
57862|NCT02299765|"~     Study Title:~      Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus~     carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive~     non-small cell lung cancer: A randomized, open-label, multiple-centre study.~      Target population-Treatment naive EGFR mutant-positive advanced NSCLC patients.~      Study Objectives - Primary Study Objective: To investigate whether intercalating and~     maintenance Gefitinib in combination with chemotherapy improve the Progression-Free Survival~     (PFS) vs. Gefitinib alone in advanced NSCLC with EGFR activating mutation.~      - Secondary Study Objective： To evaluate whether intercalating and maintenance Gefitinib in~     combination with chemotherapy improve the Objective Response Rate (ORR), Disease control~     rate (DCR), Overall survival (OS), 2-year OS rate, QOL vs. Gefitinib alone.~      Evaluation the safety of Intercalating and Maintenance Gefitinib in combination with~     chemotherapy.~      - Exploratory objective: PFS of arm A vs. PFS 1 + PFS 2 of arm B Dynamic biomarker analysis~     using blood sample~      a: The PFS 1 of arm B is the time from randomization to disease progression of 1st-line~     therapy or death from any cause, whichever occurs first. The PFS 2 of arm B is the time from~     the time of PFS 1 to disease progression of 2nd-line therapy or death from any cause,~     whichever occurs first.~      Study Design-Prospective, open-label, randomized, multi-center study.~   "
57863|NCT02299752|"~     The aim of the study was to investigate the incidence of glove perforation in cannulation of~     blood vessels (CBV) during resuscitation and compare perforation rates between single and~     double-gloves.~   "
57864|NCT02299739|"~     Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal~     medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI)~     gives rise to the need for large-scale patient studies. We assessed the prevalence of liver~     injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.~   "
57865|NCT02299726|"~     Over one million hospitalizations for acute heart failure (AHF) occur over every year in the~     United States, resulting in high mortality, re-hospitalizations, and incurred financial~     costs; yet nearly every attempt over the last 10 years to improve outcomes with novel~     therapies have all failed. In this proposal, we will study whether a generic drug known as a~     mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker),~     proven to reduce morbidity and mortality for chronic heart failure patients, is safe and~     feasible to give to AHF patients in the emergency department and during hospitalization for~     a total of 3 days. The results of this study will provide necessary and sufficient data to~     design an efficacy study in a larger population to test whether early use of a high-dose of~     mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.~   "
57866|NCT02299713|"~     The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain~     control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived~     quality of life and use of pain medications, in people with chronic knee pain.~   "
57867|NCT02299700|"~     The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine~     (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe~     abnormalities in the development of many basic psychological functions that are not normal~     for any stage in development. These abnormalities are manifested in sustained social~     impairment, speech abnormalities, and peculiar motor movements).~   "
57868|NCT02299687|"~     A clinical trial to investigate the influence of CYP2C19 polymorphism on~     pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers~   "
57869|NCT02299674|"~     The purpose of this study is to examine the path and velocity of the center of mass (CoM)~     and center of pressure (CoP) during double support of persons walking with a unilateral~     above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and~     effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory~     movements that affect the smooth trajectory of the center of mass (CoM) during weight~     transfer. The lack of control in the foot/ankle complex reduces fine motor movements,~     influencing the progression of the CoM and transfer of ground reaction forces represented by~     the center of pressure (CoP). Without control of the ankle joint, prosthetic users fall~     off of their trailing prosthetic limb during weight transfer, resulting in much more abrupt~     CoM and CoP transfers from trailing to leading limb. These abrupt movements during transfer~     not only increase stress on the sound limb, but also decrease the subject's energy~     efficiency during ambulation. The current study will further examine the CoP path and~     velocity in relation to the CoM path and velocity during double support of men with a~     transfemoral prosthesis, as well as explore how prosthetic foot ankle stiffness and~     effective length affects the CoP path and velocity.~   "
57870|NCT02299661|"~     DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to~     produce transient dose / exposure dependent increases in erythropoietin levels in subjects~     with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will~     involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group~     investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to~     dose will be randomised. On completion of this part of the study an optional fourth dose may~     be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B~     will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects~     (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from~     Part A.~   "
57871|NCT02299648|"~     This protocol is a screening protocol only. No drug intervention study will be included in~     this protocol. However, based on the molecular profiling, patients may be eligible for~     targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the~     clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1~     inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of~     clinical trials depending on the availability.~   "
57872|NCT02299635|"~     This study is designed to evaluate the preliminary anti-tumor activity and tolerability of~     PF-03084014 when administered as a single agent in the treatment of patients with advanced~     triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch~     receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for~     genomic alterations in Notch receptors (NA-)~   "
64096|NCT02218333|"~     The aim of the present study is to investigate effects of milk on body composition and~     muscle strength, inflammation, appetite, DNA damage/repair and PBMC whole genome~     transcriptomics in elderly subjects.~   "
57876|NCT02299583|"~     Background: International studies have shown that a substantial number of children and~     adolescents are exposed to potentially traumatic events. Many of these children and~     adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are~     submitted to health care departments shortly after exposure as the most common types of~     traumatic events are accidental injury, serious somatic illness or death of someone close.~     There has been some research on early psychological interventions for prevention and~     treatment of PTSD. However, very little research has examined the efficacy of~     trauma-informed practice among health care professionals (HCPs). The present trial aims to~     evaluate and compare trauma-informed health care with usual practice.~      Methods/Design: The primary clinical question under investigation is the efficacy of an~     early, trauma-informed intervention for the prevention of PTSD in children and adolescents~     following exposure to a potentially traumatic event. The trail compares a standardized~     trauma-informed practice with usual care (no intervention) in health care departments~     receiving children and adolescents after exposure to determine if trauma-informed care is~     associated with a reduction in psychological outcome measures over time. Specifically, the~     investigators examine the efficacy of health care professional's active use of~     trauma-informed standards of action and a trauma training program for HCPs in the~     intervention group. The primary outcome will be a reduction in trauma, anxiety and~     depressive symptoms on self-reports in the active intervention compared to usual care.~      Discussion: This trial will be the first controlled trial to examine a trauma-informed~     intervention carried out by HCPs. It will provide the first evidence on the efficacy of~     health care delivered by trauma-educated HCPs using trauma-informed standards of action. A~     successful implementation of this protocol will support the thesis that prevention of PTSD~     among children and adolescents benefits from a focus on the practice of HCPs. If~     efficacious, the results will be a call for future research to extend the investigation of~     interventions from psychological treatment to HCP-based care.~   "
57877|NCT02299570|"~     This is the first prospective, multi-center, double-blinded, randomized controlled study of~     a microbiota suspension derived from intestinal microbes. Patients who have had at least two~     recurrences of C. difficile infection (CDI) after a primary episode and have completed at~     least two rounds of standard-of-care oral antibiotic therapy or have had at least two~     episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients~     whose CDI returns in less than 8 weeks after the last assigned study treatment may be~     eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.~   "
57878|NCT02299557|"~     This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on~     anal resting pressure and fecal incontinence in patients with spinal cord injury.~     Approximately 17 subjects are expected to complete this 10 weeks study that will include two~     treatment periods of 4 weeks each, and one 2 weeks wash out period.~   "
57879|NCT02299544|"~     BlueWind system safety and performance in treatment of patients diagnosed with overactive~     bladder (OAB)~   "
57880|NCT02299531|"~     This study investigates the effect of varying both energy density and portion size of all~     foods at lunch on preschool children's intake. The foods used in this study are~     commercially-available, commonly-consumed foods with typical variations in energy density.~     The primary aim of the study is to investigate the independent and combined effects of~     energy density and portion size on preschool children's intake at a meal composed of foods~     typically served to this population.~   "
57881|NCT02299518|"~     This phase I trial studies the side effects and best dose of selinexor when given together~     with etoposide with or without mitoxantrone hydrochloride and cytarabine in treating~     patients with acute myeloid leukemia that has returned (relapsed) or has not responded to~     treatment (refractory). Selinexor may help stop the growth of tumor cells by blocking an~     enzyme needed for cancer cell growth. Drugs used in chemotherapy, such as etoposide,~     mitoxantrone hydrochloride, and cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving chemotherapy together with selinexor work better in treating~     relapsed or refractory acute myeloid leukemia.~   "
57882|NCT02299505|"~     A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib~     taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with~     that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged~     (ALK-positive) metastatic non-small cell lung cancer (NSCLC)~   "
57883|NCT02299492|"~     This proposed study addresses the problem of service disengagement within the mental health~     system. No matter how effective mental health practices are now or become in the future,~     they are of little value should persons with mental illnesses continue to choose not to~     receive them. Consumers have attributed their disengagement from care to having poor~     alliances with care providers, including experiences of not being listened to and not being~     offered the opportunity to make decisions and collaborate in their own treatment.~     Person-centered care planning is a field-tested intervention designed to maximize consumer~     choice and ownership of the treatment process. Providers collaborate with consumers to~     develop customized plans that identify life goals and potential barriers to achieving them.~     The proposed study tests the effectiveness of Person-Centered Care Planning (PCCP) designed~     to target barriers and efficiently implement PCCP throughout an agency. By conducting a~     randomized controlled trial with 14 community mental health clinics from two states, the~     study will assess whether PCCP improves service engagement and consumer outcomes. The study~     will also utilize qualitative methods to understand how care planning impacts service~     engagement and how implementation processes influence organizational and provider level~     behavior. Designed to bridge the science to services gap, this study focuses on two~     priorities identified by the NIMH Diversion of Services and Intervention Research:~     developing models and methods to implement effective mental health services in the community~     and the study of personalized mental health care.~   "
57884|NCT02299479|"~     Increased daytime activity in children and adolescents with type I diabetes is known to be~     associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical~     study to assess the feasibility of using activity monitor data to adjust insulin pump basal~     rates and see whether we can help prevent overnight hypoglycemia following high activity~     days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to <7 years old and~     10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and~     having them wear activity monitors and CGMs for 3 months. After an initial two-week period~     to establish activity baselines, we will recommend nighttime basal insulin rate adjustments~     based on activity monitor, CGM and insulin pump data.~   "
57885|NCT02299466|"~     The purpose of study is to build a Canadian HTPN Registry to collect pertinent demographic~     and clinical data on the HTPN population in Canada and to determine the factors affecting~     survival, complications and TPN-dependency. These results will help establish standards of~     practice and develop future multi-center studies. This will greatly benefit the HTPN patient~     population.~   "
57886|NCT02299453|"~     This randomized clinical trial is testing if telephone-administered interpersonal~     psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.~   "
57888|NCT02299427|"~     Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths~     each year in the United States. By a large margin, children suffer the highest risk - and~     children typically are bitten by familiar dogs in familiar places. Several programs exist to~     reduce pediatric dog bite risk, but few are empirically-supported or~     theoretically-motivated. None are widely disseminated. This study builds from existing child~     dog bite prevention programs to develop and then evaluate a website to teach children safe~     interactions with dogs. The website will be interactive, entertaining, and engaging,~     allowing children (target ages 4-6) to learn in a technologically-sophisticated and~     interactive environment. It will be developed based in behavioral theory. Hearkening child~     development theory, it will teach and permit practice of cognitive skills that develop in~     early childhood and are critical to safety with dogs: impulse control, perspective taking,~     and attention to details. Hearkening health behavior change theory, the website will help~     children and their parents perceive personal vulnerability to bites, recognize normative~     behavior to protect themselves, and have personal motivation to change previous habits.~     Overarching the website design will be goals to create an engaging and entertaining~     environment, and to facilitate cognitive and behavioral change on the part of both child and~     parent via multiple mechanisms. Besides teaching children, the website will educate parents~     via an innovative messaging system triggered by child attainment of points and skill~     levels.~      Following website development, an evaluation study will investigate usability and efficacy~     of the website using a repeated measures pre-test, post-test experimental design. 68~     children ages 4-6 will be recruited, complete a pre-intervention assessment evaluating~     knowledge and behavior relevant to dog safety via multiple methods, and then be randomly~     assigned to use either the newly-developed dog safety website or a control pedestrian safety~     website at home over the subsequent 2 weeks. Frequent reminders will encourage website use.~     Following the 2-week period, all children will return for a post-intervention assessment~     battery to evaluate knowledge and behavior change. Data will be analyzed using descriptive~     and inferential statistics, with primary hypotheses tested using linear mixed models.~   "
57889|NCT02299414|"~     The purpose of this study is to evaluate whether a blood pressure treatment strategy during~     pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults~     (<140/90 mmHg) compared to usual care (no treatment unless BP is severe) is effective and~     safe.~   "
57890|NCT02299401|"~     This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and~     acceptability of two medical abortion regimens that are commonly used in Latin America. The~     first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour~     intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in~     three hour intervals. This study will also aim to assess the feasibility and acceptability~     of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.~   "
57891|NCT02299388|"~     The investigators are conducting this research to study the effect of Liraglutide on blood~     pressure. Several studies have shown increased cardiovascular complications and deaths in~     diabetics with hypertension. The importance of blood pressure control in diabetes has been~     shown in many clinical trials. No drug already approved for treating Type 2 Diabetes~     Mellitus is known to reduce blood pressure along with improving diabetes. However, prior~     research studies with liraglutide have suggested that treatment with liraglutide improves~     blood pressure. This effect is seen very quickly and even prior to any weight loss. The~     mechanism behind this effect is yet to be determined.~   "
57892|NCT02299375|"~     This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15~     milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to~     standard of care (SoC).~      The primary objective of this study is to explore the therapeutic potential of losmapimod as~     a treatment to reduce the rate of exacerbations in the subset of participants with~     moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more~     moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood~     eosinophils at screening. As secondary objectives safety, effects on lung function, quality~     of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be~     evaluated.~      The duration of the treatment period is variable but will be at least 26 weeks and up to a~     maximum of 52 weeks, with the end of study date being established once the final participant~     has been randomized. The purpose of the variable dosing regimen is to enable participants to~     remain in the study for a longer duration, as it is anticipated that this will increase the~     likelihood of observing exacerbation events without increasing the overall study duration.~     It will also enable safety data on dosing periods beyond 6 months to be generated.~      Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be~     randomized to the study. Sample size re-estimation will be performed during the course of~     the study to potentially increase the sample size up to a maximum of 600 participants.~   "
57893|NCT02299362|"~     The purpose of this study is to examine the treatment, both surgical and non-surgical, of~     patients with any form of early onset scoliosis. Such treatment may include the use of~     growth friendly devices that are surgically or magnetically lengthened; or the use of serial~     body casting or bracing, or observation. Outcomes examined will be what can be seen~     physically on the patient and on x-ray, as well as parent perception of how the treatment~     effects their child with the use of a health-related quality of life (HRQOL) questionnaire.~   "
57894|NCT02299349|"~     Despite a robust multimodal pain management regimen, patients undergoing total knee~     arthroplasty (TKA) continue to report low satisfaction with postoperative pain management.~     Patient satisfaction further declines with any adverse event such as a drug reaction to~     neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain~     management throughout the hospital experience is warranted to improve patient satisfaction~     and the possibility of related adverse events. The purpose of this study is to examine if~     there is a difference in post operative pain and morphine (MSO4) total consumption for~     hospitalized TKA patients without femoral nerve block receiving an intra-operative~     periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.~   "
57895|NCT02299336|"~     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet~     re-treatment criteria will be eligible for focal laser treatment every 90 days.~   "
57896|NCT02299323|"~     The primary objective of this study is to evaluate radiographic outcomes, intra-operative~     parameters, clinical outcomes, and patient satisfaction following circumferential fusion~     using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for~     the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6~     months of non-operative treatment.~   "
57897|NCT02299310|"~     The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR~     Index in patients with chronic kidney disease.~   "
57898|NCT02299297|"~     This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment~     of moderate to severe AA, and alopecia totalis or universalis, followed by 6 months~     follow-up off drug to assess the incidence and timing of recurrence of disease or~     documentation of delayed response to treatment. There will be the option of increasing the~     treatment duration up to an additional 6 months beyond the initially scheduled 6 months of~     treatment, if clinically indicated, and at the discretion of the investigator.~   "
57899|NCT02299284|"~     A randomized control trial to test the efficacy of a new treatment involving intensive~     home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive~     home-based functional lower-limb training in children with hemiplegia. The protocols have~     been developed at TC Columbia University to be child friendly and draw upon the~     investigators experience since 1998 with intensive movement therapy in children with~     cerebral palsy. The aim is to promote either the use/coordination of movement of the hands~     or improve lower-limb balance, strength, and function. Caregivers will be trained at the~     investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks~     (90 hours total) of activities with their child in their own home. The activities will be~     supervised by the investigators team via computer. Participants do NOT need to live in the~     New York City area, but a one-time weekend visit to the investigators center is required for~     training. All measurement and treatment is performed in the home.~      Participants are randomized to receive either HABIT or lower-limb training. If caregivers~     wish, they may chose to be crossed over at the end of the study and trained to receive the~     other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more~     information: http://www.tc.edu/centers/cit/~   "
57900|NCT02299271|"~     This study evaluates post-operative pain management and narcotic consumption in patients~     receiving a fascia iliaca block with local anesthetic versus patients receiving fascia~     iliaca block with saline for total hip arthroplasty.~   "
57901|NCT02299258|"~     gastric outlet obstruction tailored versus standard stents for malignant gastric outlet~     obstruction treatments~   "
57902|NCT02299245|"~     Coronary heart disease (CHD) is one of the diseases characterised by biological aging as one~     of the important risk factors in several epidemiological studies. The mean telomere length~     and telomerase activity serve as markers for the biological age at the cellular level, with~     shorter telomeres and lower telomerase activity defining the increased biological age.~     Telomere length and telomerase activity, therefore, correlates with the risk of CHD and~     atherosclerosis. A present study states that the treatment with a statin is associated with~     a reduction in the number of clinical events but only in individuals with increased risk~     based on their telomere length. This suggests a positive relationship of telomere and~     telomerase system with the treatment with statins in CHD patients.~   "
57903|NCT02299232|"~     Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status~     I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1~     received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From~     the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation~     Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and~     separation-score was noted. If intranasal sedation failed, an intravenous canula was placed~     and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to~     receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.~   "
57904|NCT02299219|"~     Cancer is the most common potentially fatal disease of adolescence and the Internet~     represents an ideal means to deliver education, self-monitoring capabilities, and social~     support to enhance disease self-management by adolescents with cancer. While two interactive~     coping websites exist for young people with cancer, they are: (1) not interactive, (2) do~     not focus on helping youth gain skills for transition and independence, and (3) do not~     provide opportunities for meaningful social support. In summary, there is a crucial need to~     develop a comprehensive interactive Internet-based self-management program targeting AWC~     that is comprised of cancer education, self-management skills, and opportunities for social~     support, and that is cost-effective.~   "
57905|NCT02299206|"~     This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority~     controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to~     Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis~     who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups~     will administer the product with each diaper change throughout the course of the study~     period. Product can be applied liberally as needed. Diapers and skin cleansing interventions~     will stay constant throughout the treatment period. Subjects will be assessed by the study~     doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will~     also be asked to complete a daily diary that asks about changes in their baby's diaper~     dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis,~     and observations related to product use and the baby's comfort level. Parents/caregivers~     will also be given a questionnaire rating the use of the study products.~   "
57906|NCT02299193|"~     The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2~     online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits)~     on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and~     prehypertension or hypertension.~   "
57961|NCT02298478|"~     The purpose of this study is to determine the efficacy of a computer-aided self-help~     treatment for flying phobia with or without support by the therapist, compared to a waiting~     list control group.~      The principal hypothesis is that the two intervention groups will improve significantly~     compared to the waiting list control group.~   "
58018|NCT02297737|"~     This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for~     patients who have recently had a heart attack and are not participating in a standard~     cardiac rehabilitation program. Half of the 75 patients will be randomly assigned to the Tai~     Chi condition and the other half will be assigned to 12 weeks of Health Education. In~     addition to examining feasibility and acceptability, the investigators will evaluate the~     impact of participation in the Tai Chi condition on measures of cardiac health, physical~     function, self-reported health behaviors, and mental health as compared to Health Education~     within the context of this developmental/exploratory study.~   "
57907|NCT02299180|"~     Aims: Advance care planning (ACP) is considered to be one of the most promising~     interventions to enable patients with life limiting illnesses to receive treatment at the~     end of life (EOL) according to their own preferences and to promote EOL conversations~     between patients and their health care providers. Through a 2-arm randomized controlled~     trial (RCT) of patients with Class III and IV heart failure (New York Heart Association~     Functional Classification), we propose to assess:~        1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care~          consistent with their preferences as stated in the latter of the last ACP document or~          the last patient interview, compared to patients in the control arm.~        2. Heath care costs during study duration between patients in ACP and control arms.~        3. Patient's understanding of own illness and their participation in decision making~          between the ACP and control arms.~        4. Patient's quality of life, anxiety and depression between ACP and control arms.~      Methodology: A total of 254 patients with advance heart failure will be randomized to~     receive intervention (ACP arm; N=127) or usual care (control arm; N=127).~      The RCT will be conducted at the National Heart Centre and Singapore General Hospital.~     Patients in both arms will be followed for one year or till death, whichever is earlier, and~     interviewed every 4 months during this duration.~      Clinical Significance: If benefits of ACP are shown to add value through this trial, then~     this study will help to promote acceptance of ACP among patients and health care providers~     across Singapore and elsewhere.~   "
57908|NCT02299167|"~     The optimal anesthetic technique would provide excellent operating conditions, rapid~     recovery, early discharge, no postoperative side effects, and high patient's satisfaction.~     In addition to increasing the quality and decreasing the costs of the anesthetic services~     (1). Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a~     specific type of surgery - has become very popular technique) 2(for some orthopedic and~     gynecological surgeries [3-9].~      Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards~     S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries~     (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle~     block (11, 12).~      Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have~     been used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose~     has yet to be determined.~      The objective of this study is to determine the minimal effective dose of hyperbaric spinal~     bupivacaine required to induce a reliable and satisfactory saddle block for perianal~     surgeries (using a modified Dixon's up-and-down method.~   "
57909|NCT02299154|"~     This study aims to prospectively examine the memory problem perceptions of patients with~     memory complaints [MCs] and their accompaniers during the diagnostic process.~   "
57910|NCT02299141|"~     There has been limited benefit with angiogenesis inhibitor drugs when used with molecularly~     selected patients in non-small cell lung cancer (NSCLC). The investigators propose that~     patients who are molecularly selected for treatment with nintedanib based on the presence of~     mutations (VEGFR1-3, PDGFR-A, PDGFR-B, and FGFR1-3) will have clinically meaningful benefits~     in terms of response rate (RR) and progression-free survival (PFS). Furthermore the~     investigators plan to perform exome sequencing of paired tumor (pre and post treatment) in~     order to better define molecular marker predictors for response and resistance.~   "
57911|NCT02299128|"~     Therefore, the purpose of this pilot study is to determine the feasibility of conducting a~     randomized clinical trial (RCT) on physical therapist treatment for dizziness after~     sports-related concussion. The specific research question for this pilot RCT is: What is the~     feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a~     sports-related concussion to explore the effectiveness of directed vestibular~     rehabilitation, neuromotor retraining, and/or manual physical therapy (PT) when compared to~     sham treatment? The findings of this study (for both feasibility and effect size) will be~     used to inform and direct revisions to the methods for a larger RCT on this population.~      Primary Aims:~      Specific Aim 1: Assess the feasibility of the following: recruitment and retention of~     participants, required resources for project management, and assessment of patient safety.~      Specific Aim 2: Estimate the size of the effect between skilled physical therapist~     intervention and a sham treatment for the recovery rate for athletes with a concussion who~     have dizziness 10 - 14 days post-concussion.~   "
57912|NCT02299115|"~     Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy~     Neurology/ Child Neurology Society practice parameter update on the medical treatment of~     infantile spasms concluded: adrenocorticotrophic hormone or vigabatrin may be offered for~     short-term treatment of infantile spasms. There was insufficient evidence to recommend the~     use of prednisolone, dexamethasone, and methylprednisolone. The cost of ACTH and the side~     effects of vigabatrin have led to the consideration of alternative medications to treat~     infantile spasms. The United Kingdom Infantile Spasms Study (UKISS) in 2004, comparing the~     efficacy of intramuscular synthetic ACTH to high dose oral prednisolone, showed a response~     rate of 74% for ACTH and 70% for prednisolone. Since the UKISS paper was published, many~     institutions in the United States and Australia have used oral prednisolone instead of ACTH,~     partly due to the exorbitant cost of intramuscular ACTH but also its ease of use and better~     adverse event profile compared to ACTH. Prednisolone and vigabatrin are both oral~     medications, which can be initiated promptly upon diagnosis of infantile spasms, expediting~     treatment and shortening treatment lag time. Because the UKISS trial is the only Class 3~     study providing evidence for oral prednisolone in the first-line treatment of infantile~     spasms, further prospective studies are needed.~   "
57913|NCT02299102|"~     This single center, randomized, controlled trial will compare the manual standard bone~     marrow aspiration device to the powered ported bone marrow aspiration device for use in the~     iliac crest in healthy adult volunteers. The study will compare the subjects' perceived~     level of pain, time to sample acquisition, and quality of specimen yield of these devices.~     To serve as their own control, each subject will receive bilateral bone marrow aspiration~     procedures using both the manual standard and powered ported devices.~   "
57914|NCT02299089|"~     This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,~     and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a~     functional, well-differentiated NET, with carcinoid symptoms.~   "
57915|NCT02299076|"~     The purpose of this study is to determine whether a behavioral economics solution impacts~     smoking cessation engagement and quit rates.~   "
57917|NCT02299050|"~     Purpose This study will examine the effect of the addition of Cycloset upon glucose~     metabolism (glycemic control including post prandial glucose metabolism) in individuals with~     inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon~     (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care.~      Both a mechanistic rationale and empirical experimental evidence implicate a beneficial~     interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon~     postprandial hyperglycemia in insulin resistant states. One of the actions of the incretin~     mimetics such as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory~     response to plasma glucose (see drug labeling information; www.fda.gov). Thus the~     combination of Cycloset that is working as a post prandial insulin sensitizier with~     therapies that increase post prandial insulin would be expected to provide complimentary~     glucose lowering effects. To date, however, no such studies investigating the interactive~     effects of a GLP-1 analog and Bromocriptine-QR (Cycloset) have been conducted in humans.~      Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4~      Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label,~     N/A, Safety/Efficacy Study~      Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients~     Inadequately Controlled on GLP-1 Analogue Therapy~   "
57918|NCT02299037|"~     The purpose of the study is to determine if pre-operative neuropsychological~     characteristics, apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum~     biomarkers can predict those most at risk of post-operative delirium. Patients over the age~     of 65 years undergoing elective primary hip or knee arthroplasty in Musgrave Park Hospital~     are invited to take part. Participants undergo a pre-operative neuropsychological assessment~     which is repeated 6-12 weeks post-operatively at the time of surgical review appointment. At~     the time of surgery advantage is taken of the necessary venous cannulation and spinal~     anaesthetic to gain venous blood and CSF samples respectively. Venous blood is also sampled~     post-operatively. Patients are assessed daily for delirium, using the Confusion Assessment~     Method, until discharge.~   "
57919|NCT02299024|"~     The investigators overall study objective is to improve patients knowledge and safe use of~     opioid pain relievers upon discharge from the Emergency Department.~   "
57920|NCT02299011|"~     The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro~     drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have~     biodegradable polymer for the treatment of all-comers' coronary artery diseases.~   "
57921|NCT02298998|"~     This is a two-arm, randomized-controlled pilot study with 2 year duration. The~     intervention refers to surveillance based on the European Association of Urology (EAU)~     guidelines and the control refers to surveillance based on the American Urological~     Association (AUA) guidelines.~   "
57922|NCT02298985|"~     Schizophrenia is still remained one of the disabling disorders despite progress in treatment~     of mental disturbances. Ten to thirty percents of patients have a little or no benefit from~     treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of~     these patients has remained a persistent public health problem since medication-resistant~     patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated~     from this perennial herb. It possesses a variety of pharmacological activities, including~     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses~     the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of~     curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic~     schizophrenia patients.~   "
57923|NCT02298972|"~     This study evaluates the value of a nursing symptom support en selfmanagement intervention~     for adult patients with cancer treated with chemotherapy. Using a prospective sequential~     design with a comparison group who receives standard care and a (later) intervention group~     who gets the nursing intervention, we will evaluate the effect of this nursing intervention~     on overall symptom distress (primary outcome) and other measures of symptom burden,~     self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews~     with some participants of the intervention group, we will study the patient experience of~     the intervention.~   "
57924|NCT02298959|"~     This phase I trial studies the side effects and best dose of ziv-aflibercept when given~     together with pembrolizumab in treating patients with solid tumors that have spread to other~     places in the body. Ziv-afibercept works by decreasing blood and nutrient supply to the~     tumor, which may result in shrinking the tumor. Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving~     ziv-aflibercept together with pembrolizumab may be a better treatment for patients with~     advanced solid tumors.~   "
57925|NCT02298946|"~     Background:~      - T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep~     T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in~     people with cancer. They think the drug might work even better when combined with a certain~     type of radiation therapy.~      Objective:~      - To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic~     body radiation therapy (SBRT) directed to the liver.~      Eligibility:~      - People age 18 and older with metastatic colorectal cancer. Their cancer must have spread~     to the liver and not be responding to treatment.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and~          urine tests. Their tumors will be measured with computerized tomography (CT) scans or~          magnetic resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an~          electrocardiogram (ECG) heart test.~        -  Participants will have a small part of their tumor removed by needle (biopsy).~        -  Participants will have 8 study visits over about 10 weeks.~        -  At 1 visit, they will have another tumor biopsy.~        -  At 1 visit, they will get a chemotherapy drug through a vein (IV).~        -  At 6 visits, they will receive AMP-224 through an IV.~        -  At 1 or 3 visits, they will have SBRT. CT scans will map the position of their tumor.~          Radiation beams of different intensities at different angles will be directed to the~          tumor.~        -  At all visits, some screening procedures may be repeated.~        -  After treatment ends, participants will have 7 follow-up visits over about 5 months.~          Blood will be drawn. Some screening procedures may be repeated.~   "
58107|NCT02296567|"~     To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea (~     aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF)~     in the systemic circulation of Age Related Macular Degeneration patients currently treated~     with these medications.~   "
57926|NCT02298933|"~     Background:~      - Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens~     when people do not have enough normal platelets. Getting a transfusion of another person s~     platelets can help stop too much bleeding. But because these cells are from other people,~     the body may reject them,putting them at risk for serious bleeding complications. This~     conditions is called alloimmune platelet refractoriness . There are evidence that in many~     patients, platelet counts fail to increase after a platelet transfusion because the~     transfused platelets are destroyed by the body s defence soldier, called complement .~     Researchers want to see if a drug, that inhibits complement, can help increase platelet~     levels and reduce bleeding~      Objectives:~      - To see if eculizumab increases platelet levels more after a transfusion. To see if it~     reduces the chance of bleeding too much.~      Eligibility:~      - Adults 18-75 years old who have thrombocytopenia and alloimmune platelet refractoriness.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have the procedures listed below. They can have them while they are~          in the hospital. Or they can go to the outpatient clinic for them. Each visit may take~          up to 3 hours.~        -  Participants will get a meningitis vaccine if needed. Then they will get the study drug~          as an infusion.~        -  Participants will have a platelet transfusion. Their blood will be drawn every 24 hours~          until the platelet count is less than 10,000 per 1 microliter of blood.~        -  They will take antibiotics for 14 days.~        -  Participants will have a checkup and blood drawn twice a week for 2 weeks. They will~          get more transfusions if needed.~   "
57927|NCT02298920|"~     This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six~     male healthy volunteers.~   "
57928|NCT02298907|"~     The present study is a retrospective analysis of prospectively collected clinical data.~     Anonymized data from patients collected during routine clinical care from 7 major colorectal~     units in the UK who perform pre-operative cardiopulmonary exercise testing will be pooled at~     a central location (Aintree University Hospitals, Liverpool) and used to validate the~     relationship between cardiopulmonary exercise testing (CPET) variables and short term~     post-operative outcomes after major colorectal surgery. Here the investigators will attempt~     to validate a study entitled Cardiopulmonary exercise variables are associated with~     postoperative morbidity after major colonic surgery - a prospective blinded observational~     study previously published by our team in Liverpool .~   "
57929|NCT02298894|"~     Despite the wide availability of advanced lipoprotein tests, no reference standard exists~     for Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the~     assays. Newer methods for estimating LDL particle numbers, including nuclear magnetic~     resonance (NMR) spectroscopy and vertical auto profile (VAP) are currently under~     investigation. NMR has been proposed as having the best correlation with adverse~     cardiovascular outcomes. Unfortunately, the accuracy of LDL-C or LDL particle number~     measurements is currently not monitored by national standardization programs. Direct~     comparisons between the various testing methods have been limited restricting our ability to~     accurately interpret and compare values across vendors and lipid parameters.~      Our hypothesis is that:~        1. LDL particle count numbers, as determined by NMR (Liposcience), provides the best~          estimates of cardiovascular risk.~        2. Discrepancies exist between the LDL particle count by NMR and other values as presented~          by calculated LDLC and directly measured LDL (VAP and ion mobility).~      The investigators will enroll 100 patients recruited from the Lipid Clinic at the Scripps~     Center for Integrative Medicine. Each patient will have one blood draw from which four tests~     will be analyzed. Risks are associated with drawing blood, which will be minimized by using~     Scripps Clinic Lab technicians. The potential loss of personal health information will be~     reduced by limiting access to study and lab staff and keeping information password-protected~     on Scripps servers.~   "
57930|NCT02298881|"~     The purpose of this study is to collect samples from the surface of eyelids to try to grow~     and identify bacteria or fungus that might be present, and to try to understand why people~     have dry eye symptoms.~   "
57931|NCT02298868|"~     The purpose of this study is to determine the safety and efficacy of the medication Baclofen~     for treatment of muscle cramps in patients with cirrhosis.~   "
57932|NCT02298855|"~     The purpose of this study in women who have completed primary treatment for ovarian cancer~     is to investigate the effects of individualised follow-up care delivered by a nurse compared~     to conventional medical follow-up on quality of life and mood. The investigators aim to~     determine if the individualised treatment is acceptable to women compared to the~     conventional treatment.~   "
57933|NCT02298842|"~     Verify that in vitro platelet quality (functional assays) of platelets collected on the~     Trima Accel System, Version 6.4, diluted in InterSol Solution, and stored for five days meet~     FDA requirements.~   "
57934|NCT02298829|"~     This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a~     12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month~     open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc.~     After participation in one of the aforementioned studies, subjects will be followed yearly~     for up to 4 consecutive long-term follow-up visits with at least 6 months between~     consecutive visits~   "
57935|NCT02298816|"~     The goal of this study is to develop a vaccination registry system for Aurora Health Care~     patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to~     prospectively characterize vaccination history and outcomes such as infection in these~     patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection~     (influenza, pneumonia, other) related to vaccination in this patient population will be~     evaluated.~   "
57978|NCT02298257|"~     This phase II trial studies the side effects and the best dose of brentuximab vedotin and~     combination chemotherapy work in treating patients with stage III-IV human immunodeficiency~     virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin,~     can block cancer growth by finding cancer cells and causing them to die. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving brentuximab vedotin together with combination~     chemotherapy may kill more cancer cells.~   "
70523|NCT02134275|"~     The purpose of this study is to evaluate the benefits and feasibility of a whole body~     vibration (WBV) exercise program as a method of preventing weight gain in young adults.~   "
57936|NCT02298803|"~     Hypoglycaemia is the most common acute complication of diabetes and can limit therapeutic~     efforts to improve glycaemic control. It is a potential side effect of drugs used to treat~     diabetes, particularly with the use of sulfonylurea (SU) treatment. It has been demonstrated~     that hypoglycaemia causes the prolongation of corrected QT (QTc) interval, which is~     associated with ventricular arrhythmias and sudden death. Hypoglycaemia in T2DM has recently~     come into focus with the results of the ACCORD, ADVANCE and VADT trials.~      In this study, the investigators aim to examine the association of hypoglycaemia and glucose~     fluctuations on QT-interval and QT variability in patients with type 2 diabetes treated with~     SU. Patients will be studied using simultaneous Continuous Glucose Monitoring (CGM) and~     ambulatory ECG monitoring (Holter).~      Study participants will be recruited from the Diabetes Centre, RPAH or from specialist~     consulting rooms. They will be required to attend the Diabetes Centre on two occasions.~      At the first visit, blood will be collected and CGM and Holter monitoring commenced. At~     Visit 2, i.e. two days later, the patient will return to the Diabetes Centre to have the~     equipment removed. The data obtained from the CGM and Holter monitor will then be downloaded~     for review and analysis.~   "
57937|NCT02298790|"~     The goal of this application is to understand the connection between people's eating habits~     and the risk for developing diabetes, obesity, and cardiovascular disease.~   "
57938|NCT02298777|"~     Currently investigators do not have diagnostic and prognostic markers for SSc which almost~     always starts with a vascular disease (Raynaud's disease) isolated for several years.~      The primary purpose is to highlight discriminating metabolic profiles depending on the~     characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular~     lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3~     years).~      Secondary purposes:~        -  Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs~        -  Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective~          tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy~          controls~        -  Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc~          patients~   "
57939|NCT02298764|"~     Aim The aim is to test whether a short psychotherapeutic intervention targeting Post~     Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the~     outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain~     development.~   "
57940|NCT02298751|"~     Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond~     well during evidence-based psychological treatment, but also that a large proportion relapse~     when discharged from treatment and confronted with alcohol in real life. Cue Exposure~     Therapy (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the~     likelihood of relapse. The aim of this study is to investigate whether CET as aftercare~     increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals.~      Design and methods: The study is implemented as an investigator-blinded randomized~     controlled trial. A total of 300 consecutively enrolled AUD patients, recruited from an~     alcohol outpatient clinic will be randomized to one of the three following aftercare~     treatment groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n~     = 100), and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental~     groups ((A) and (B)) will achieve better treatment outcomes as compared to the control group~     ((C)), and It will be explored whether CET as smartphone application is as effective as CET~     as group therapy. The groups will be compared in a number of parameters including alcohol~     intake, cravings and copings-strategies.~      Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will~     make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT~     approach. Although, CET is most often regarded as one of the behavioral methods in CBT,~     there appears to be segregation in the empirical literature when it comes to treatment of~     addictive disorders. However, CET may allow the patient to practice and gain control over~     alcohol cue reactivity and associated high-risk situations in an inter-mediating therapeutic~     context before the patients inevitably are confronted by them. In this way, one might expect~     the transition from treatment to daily life less overwhelming and CET may help prevent~     relapse in the long term. Thus, CET may be particularly suitable as aftercare.~   "
57941|NCT02298738|"~     Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most~     common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at~     particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system~     (RAS) which is activated in hypertension may be the underlying mechanism of AF among~     hypertensive patients.~      Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension,~     cardiovascular disease and obesity. Increased RAS activity is one of the postulated~     mechanisms by which vitamin D deficiency may trigger the development of hypertension and~     various cardiovascular diseases. On the basis of these data we hypothesized that~     hypovitaminosis D might be associated with new-onset AF among patients with hypertension.~   "
57942|NCT02298725|"~     To determine if consumption of different diet plans that both are nutritionally-adequate and~     provide energy to maintain body weight, alters fasting insulin concentrations, shifts other~     common clinical markers of metabolic disease risk, and affects metabolomic profiles that~     reflect glucose, lipid, and amino acid metabolism.~   "
57943|NCT02298712|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Hurler~     disease from plasma. Testing for clinical robustness, specificity and long-term stability of~     the biomarker.~   "
57944|NCT02298699|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sly disease~     from plasma and saliva. Testing for clinical robustness, specificity and long-term stability~     of the biomarker.~   "
57945|NCT02298686|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sanfilippo~     Type A-B-C-D disease from plasma and saliva. Testing for clinical robustness, specificity~     and long-term stability of the biomarker.~   "
57946|NCT02298673|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Mucolipidosis Disorder type I, II, III, IV disease from plasma. Testing for clinical~     robustness, specificity and long-term stability of the biomarker.~   "
57979|NCT02298244|"~     Some patients with a long history of AF develops PH reactive type with an increase in~     pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular~     wall. RFA PVI + RFA GP is the gold standard in the treatment of patients with persistent~     AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is~     adjacent to the roof and part of the front of the left atrium. In the projection of this~     area are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary~     artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency~     denervation of the pulmonary artery improves the quality of life in patients with PH.~   "
57947|NCT02298660|"~     The purpose of this study is to investigate the impact of 200 U intradetrusor injected~     OnabotulinumtoxinA (Botox, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic~     detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those~     with chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder~     dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly~     managed, it may result in myocardial infarction,stroke, seizure, intracerebral hemorrhaging~     or even death. Reducing AD would dramatically improve the health and well-being of Canadians~     with SCI, and positively impact health care costs. There are an estimated 7,343 hospital~     re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year~     cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by~     only 10% over this time period could result in a costs savings of $66 million for Canada.~      Considering these statistics, the present study could be a first attempt to evaluate the~     economic impact of using Botox to manage the urinary bladder following SCI. We will be able~     to examine its impact on episodes of AD and consequently calculate the cost saving for the~     Canadian health system. A significant number of individuals with SCI will require frequent~     emergency room visits due to episodes of uncontrolled AD that originate predominately from~     the urinary bladder. There is clinical evidence demonstrating that costs of bladder~     management following SCI will depend on the understanding of the volumes that the urinary~     bladder can safely hold. This is one of the positive outcomes that have been established in~     previous trials of Botox therapy for the neurogenic bladder.~      Hypothesis: 200 U of intradetrusor injected Botox (20 sites, trigone sparing) for neurogenic~     bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one~     month following treatment.~   "
57948|NCT02298647|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     metachromatic leukodystrophy disease from plasma and saliva. Testing for clinical~     robustness, specificity and long-term stability of the biomarker.~   "
57949|NCT02298634|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Farber~     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
57950|NCT02298621|"~     The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with~     metabolic syndrome.~   "
57951|NCT02298608|"~     Background:~      Electroporation or electropermeabilisation is a novel technique with the potential to~     overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling~     between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied~     current reaches a certain threshold these 'nanopores' become permanent resulting in cell~     death. The use of electric current means that IRE is not susceptible to 'thermal sink'~     leading to consistent ablation results. IRE ablation targets the cell membrane, sparing~     tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting~     system.~      The first in human studies have proven the safety of IRE for the ablation of small renal~     masses. However the efficacy of IRE through histopathological examination of an ablated~     renal tumour has not yet been studied, compromising the correct and scientific evaluation of~     this new technology.~      Primary Objectives:~        -  To determine the efficacy of IRE ablation of renal masses , measured by histopathologic~          examination of the targeted tumour.~        -  To determine the safety of IRE ablation of renal masses, by evaluating device and~          procedural adverse events.~      Secondary Objectives:~        -  To evaluate the efficacy of MRI in the imaging of ablation success, extend of the~          ablation zone, one and four weeks post IRE ablation.~        -  To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the~          ablation zone, one and four weeks post IRE ablation.~      Population:~      10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for~     radical nephrectomy.~      Intervention:~      Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical~     nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS~     imaging. After radical nephrectomy histopathological examination will be performed to~     evaluate IRE ablation success.~   "
57952|NCT02298595|"~     This study evaluates the combination of BYL719, cisplatin and cetuximab as induction~     chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph~     node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy~     (IMRT) in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal~     squamous cell carcinoma (OPSCC).~   "
57953|NCT02298582|"~     The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain~     induced by wound care and rehabilitation in the elderly. The project would also provide a~     preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.~   "
57954|NCT02298569|"~     The purpose of this before-after study is to determine the effectiveness of a~     multidimensional intervention to increase the rate for early discharge of low-risk mothers~     and the healthy newborn in a perinatal network.~   "
57955|NCT02298556|"~     To describe the effectiveness of angiotensin-converting enzyme inhibitor and~     non-dihydropyridine calcium channel blocker single pill combination on systolic blood~     pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2~     diabetes~   "
57956|NCT02298543|"~     The purpose of this study is to evaluate the natural course of coronary spasm patients~     presenting aborted sudden cardiac death and analyze risk factors.~   "
57957|NCT02298530|"~     Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure~     during acute mental stress.~   "
57958|NCT02298517|"~     The aim of this study is to evaluate the effects of the use of breathing exercises with~     inspiratory loading on respiratory muscle strength and endurance, lung volumes and~     capacities and thoracoabdominal mobility in patients after bariatric surgery.~      It is believed that the use of inspiratory load may mitigate the negative effects of~     surgical trauma on respiratory muscle dysfunction, preserving respiratory muscle strength,~     lung volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in~     the postoperative period.~   "
57959|NCT02298504|"~     In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a~     pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy~     involves removing the top 1/2 of the pulp, placing a medication/material on the pulp,~     covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this~     pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and~     IPT in the treatment of deep decay in children's primary molars.~   "
57960|NCT02298491|"~     The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the~     improvement and long-term stabilization of clinical and radiographic abnormalities that~     occur in patients with CNS sarcoidosis. In addition, it will also look at whether treatment~     will be also associated with improvement in measures of quality of life. The treatment of~     CNS sarcoidosis involves the use of either corticosteroids such as prednisone or potent~     immunosuppressive agents such as methotrexate, both which can induce severe long term side~     effects. The adverse effects of steroids may be avoided by treatment with~     adrenocorticotropic hormone (ACTH), which is available for patient use as H.P. Acthar® Gel.~     The efficacies of H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on~     quality of life have not been previously studied. In addition, little is known regarding the~     expression of immune markers in CNS sarcoidosis and the association of such markers with~     disease activity and response to treatment.~   "
64249|NCT02216344|"~     The primary objective of the study is to validate the proposed claims for the OxiCable~     device, for pulse rate and saturation accuracy in a diverse subject population over a~     specified saturation range.~   "
57962|NCT02298465|"~     Extracorporeal shockwave lithotripsy (ESWL) for urinary stone is common and widespread~     nowadays. Approximately 80% of urinary stones are treated by ESWL. Traditionally distal~     ureteric stones are treated with ESWL in the prone position. However, as some patients~     cannot tolerate lying in the prone due to medical illness such as chronic obstructive~     pulmonary disease (COPD), some authors have reported using the supine approach of ESWL for~     treatment of distal ureter stones. No serious complications had developed in the patients~     who underwent supine approach. Only minor complications such as self-limiting blood in the~     urine, painful passage of urine, or local pain that had responded to oral painkillers. There~     were no serious complications encountered in children as well. In the most recent~     retrospective review by Tolley et al, they had revealed that patients who had underwent~     supine ESWL for distal ureteric stones had an improved stone-free rate compared with the~     traditional prone approach.~      Patient with radio-opaque distal ureteric stones (stones below the sacroiliac joint) on KUB~     X-ray, who have opted for ESWL treatment, are randomized into two groups: one undergoing~     ESWL in the supine position and the other undergoing ESWL in the prone position. Patients~     will be observed for two hours after ESWL before being discharged. Oral painkillers as~     necessary will be provided to the patient. The patients will have a KUB Xray at 2 weeks~     post-ESWL, and then monthly afterwards if required. If there are residual stones at the~     2-week follow-up, the patient will be offered ESWL again. Patients are free to withdraw from~     the study at any time and will continue to be managed as per usual.~      The investigators aim to have 130 patients, with 65 patients in each group with an interim~     analyses to be performed when 66 patients have been recruited (33 patients in each group).~   "
57963|NCT02298452|"~     The reason for this study is to evaluate a new hearing aid product generation replacing the~     one on the market. The goal is to evaluate the audiological performance, usability as well~     as features and functions.~   "
57964|NCT02298439|"~     The purpose of the Non-Alcoholic Fatty Liver Disease (NAFLD) registry is to collect~     demographic and clinical data on patients being treated for NAFLD and to determine the~     factors affecting the progression of the disease as well as the success of different~     treatment strategies.~   "
57965|NCT02298426|"~     This study aims to explore the effectiveness of body constitution classification based~     comprehensive health management intervention on obese population.~   "
57966|NCT02298413|"~     The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb~     BVS implantation in a real world, all-comers population of consecutive patients, as treated~     according to the indications, techniques and protocols used in the participating~     institutions.~   "
57967|NCT02298400|"~     The purpose of this study is to compare the comfort of three commercially available contact~     lenses.~   "
57968|NCT02298387|"~     This is an open-label Phase 1 dose escalation and expansion study of OMP-305B83 in subjects~     with previously treated solid tumors. Study includes a dose escalation phase and expansion~     phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers,~     and efficacy.~   "
57969|NCT02298374|"~     The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder~     persons who receive homecare services, but still are relatively independent in most~     activities of daily living. The model focuses on early identification of decline in function~     and intervention in the home environment through close cooperation between the participant,~     homecare services and therapists.~   "
57970|NCT02298361|"~     Health insurance is important for children. Public insurance programs are available to many~     children, but some families report being confused about how to get and keep this insurance.~     Community Health Centers (CHCs) can help families get and keep health insurance for their~     children.~      The investigators will work with families, policy makers, and community health care~     providers and staff to develop and test new computer health information technology (IT)~     tools to help health care clinics find pediatric patients in need of insurance and~     communicate with their families about public insurance programs. These tools will be based~     on technologies currently used to help patients and clinics manage chronic diseases. The~     investigators will test the tools by comparing four clinics using the tools and four clinics~     not using the tools. The investigators will look to see if children in the clinics using the~     tools are more likely to have health insurance and also more likely to receive certain~     health care services, compared to children in the clinics without such tools. The~     investigators will also look at health insurance rates and health care services for a larger~     population of Oregon children.~   "
57971|NCT02298348|"~     This study will combine three drugs: sorafenib, cyclophosphamide and topotecan.~      Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this~     combination. The investigators first need to find out the highest dose of sorafenib that can~     be given safely together with cyclophosphamide and topotecan. This is the first study to~     test giving these three drugs together and will help determine the highest dose of sorafenib~     that can safely be given together with cyclophosphamide and topotecan to patients with~     resistant/relapsed neuroblastoma.~   "
57972|NCT02298335|"~     This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol~     (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of~     adult idiopathic nephrotic syndrome.~   "
57973|NCT02298322|"~     Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using~     Cryolipolysis. Healthy adult men and women with submental skin fold thickness > 1cm who~     desire reduction of submental fat.~   "
57974|NCT02298309|"~     The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of~     a Test & Treat TB strategy on a mobile HIV screening unit in South Africa and (2) to~     assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy~     for maximizing linkage to TB care and treatment completion.~   "
57975|NCT02298296|"~     The purpose of the study is to to determine the natural history of positive psychological~     states, health status, and functioning, over an 8 week period following admission for an~     acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline~     to 8-week follow-up with corresponding changes in the completed proof-of-concept~     intervention trial (NCT02004158).~   "
57976|NCT02298283|"~     This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in~     patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity~     after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).~   "
57977|NCT02298270|"~     This study tests the efficacy of an 8-week, Skype-based, group resiliency training~     intervention (The Relaxation Response Resiliency Program) for improving psychological stress~     in patients with Neurofibromatosis. A control group will receive a general health education~     curriculum. The investigators hypothesize that patients will improve on measures of~     psychological stress as a result of the resiliency program.~      A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a~     sub-population: patients with NF2 who are hard of hearing.~   "
57981|NCT02298218|"~     In this clinical study, meloxicam will be used to the patients who are older than 2 years~     and underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after~     the medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver~     stiffness scores will be compared before and after the medication of meloxicam, and the roll~     of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their~     hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug,~     meloxicam is safe medicine which is used to treat pain or inflammation caused by~     osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old.~     It may also be used for purposes not listed in the medication guide. It will be taken once a~     daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group).~     After 6 months of medication, the maintenance will be decided by the comparison of liver~     stiffness score before and after the intervention.~   "
57982|NCT02298205|"~     African American (AA) children carry a disproportionate burden of mortality and morbidity in~     asthma. A major contributor to racial disparity in asthma is lack of adherence to~     guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment~     (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which~     patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal~     of our study is to identify an acceptable, pragmatic and effective approach to asthma~     management in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more~     acceptable than provider-based adjustment (PBA), equally effective in improving pediatric~     asthma outcomes, and will reduce the cumulative dose of ICS needed for asthma control.~     Therefore, in the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African~     American children (ASIST) study, we propose a randomized, open-label, 2-arm, parallel,~     pragmatic trial in which we will randomly assign 200 AA children to either receive SBA or~     PBA for 12 months. The primary outcome is asthma control as measured by the Asthma Control~     Test (ACT). We propose that asthma control in the SBA group will be equivalent to the PBA~     group after 12 months. Secondary outcomes include monthly cumulative ICS dose, exacerbation~     rate, quality of life, lung function, adherence and satisfaction with the treatment plan.~   "
57983|NCT02298192|"~     This trial is conducted in Europe, North America and the United States of America.~      The aim of this trial is to compare two different titration algorithms of insulin~     degludec/liraglutide.~   "
57984|NCT02298179|"~     The purpose of this study is to evaluate the safety and immunogenicity of two doses of the~     investigational RSV F subunit vaccine administered intramuscularly (IM). In this current~     Phase 1, first-in-human study, the three different antigen amounts that have been selected~     will be evaluated in a stepwise manner in three different cohorts (cohort 1: low dosage of~     RSV F subunit vaccine, cohort 2: middle dosage of RSV F subunit vaccine, and cohort 3: high~     dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum~     hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be~     evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels~   "
57985|NCT02298166|"~     The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center~     trial in adult patients with relapsed or refractory AML harboring an activating FLT3~     mutation as defined in the inclusion /exclusion criteria.~      An initial safety run-in phase of the study will be performed in an open- label~     administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone~     and cytarabine (MC) in 12 patients according to the experimental arm of the study. After~     completion of this safety run-in phase, toxicity and response data will be provided to the~     external Data and Safety Monitoring Board (DSMB) and the Trial- Committee by the~     Coordinating Investigator. The Trial Committee will decide on the basis of these data and~     the recommendation of the DSMB on dose- modification and the further conduct of the study~     with regard to the double-blinded, placebo-controlled, randomized phase of the study.~      The double-blinded, placebo-controlled randomized portion will start after the completion of~     the safety run-in phase and positive opinion of the Trial Committee.~      Crenolanib starts on day 7 of MC and is given continuously thereafter, except for days of~     chemotherapy; if receiving allogeneic HSCT, crenolanib is held during conditioning and~     transplant and restarts no sooner than 30 days after transplant.~      Sample size randomized phase: 276 patients~      Primary objective: To evaluate the impact of crenolanib given in combination with salvage~     chemotherapy and consolidation including allogeneic hematopoietic stem cell transplantation~     and ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall~     survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating~     mutations.~   "
57986|NCT02298153|"~     This study will evaluate the safety and tolerability of epacadostat (INCB024360)~     administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced~     or metastatic non-small cell lung cancer (NSCLC) that have been previously treated with~     platinum-based chemotherapy and Stage IV urothelial carcinoma who have failed a~     platinum-based chemotherapy regimen. The study will be conducted in two phases. The dose~     escalation phase will utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or~     a Pharmacologically Active Dose (PAD) of the combination. This will be followed by a dose~     expansion phase, which will be comprised of three cohorts. Expansion Cohorts 1 & 2 will~     further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and~     pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the~     change in biomarker expression following treatment with epacadostat as monotherapy followed~     by epacadostat and atezolizumab administered in combination.~   "
58040|NCT02297451|"~     Background:~      Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is~     normally created at the level of the wrist, but occasionally it is created in the elbow when~     there is no suitable vessel in the forearm. The most common type of elbow (antecubital)~     fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal~     syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using~     proximal radial or ulnar artery as inflow has been described and shown to have a lower rate~     of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence~     of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar~     artery as inflow.~   "
60867|NCT02260531|"~     This research study is evaluating the effectiveness of the drug called cabozantinib (alone~     or in combination with trastuzumab) as a possible treatment for advanced breast cancer in~     which the cancer has spread to the brain.~   "
57987|NCT02298140|"~     INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a~     substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in~     2012 (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and~     elimination strategies is severely compromised. Sub-optimal health workers' performance in~     treating malaria cases was a major contributor to the decay, effecting both treatment and~     patient adherence. If these quantified system failures remain unchecked it will pose major~     barrier in achieving malaria control and elimination goals. There is growing evidence that~     mobile phone text message reminders can improve health workers' compliance and patients'~     adherence to malaria treatment guidelines. Tanzania has recently harnessed all public sector~     health worker phones into Short Message System (SMS) platform. The investigators intend to~     exploit this opportunity in a randomized trial of messages to substantially reduce the decay~     documented by the INESS platform.~      The null hypothesis: Sending automated text message reminders to health workers on malaria~     diagnosis and treatment recommendations, will not have any effects in the quality of malaria~     case management.~   "
57988|NCT02298127|"~     The purpose of this study is to evaluate the potential efficacy of auricular acupressure to~     stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal~     symptoms among attendees in primary healthcare settings.~   "
57989|NCT02298114|"~     Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major~     muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the~     loss of muscle mass.~   "
57990|NCT02298101|"~     Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer~     specifically designed for spontaneously breathing patients. This device has not been~     investigated in vivo yet.~      It's known that using a spacer during nebulization improves aerosol delivery. We~     hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in~     comparison to a standard jet nebulizer.~   "
57991|NCT02298088|"~     Administration of TicagRElor in pAtients with ST elevation myocardial infarction treated~     with pharmacological Thrombolysis~   "
57992|NCT02298075|"~     The primary objective of the study is the evaluation of sustained response rate after~     discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or~     chronic pITP patients who failed one or more therapy lines, splenectomy included.~   "
57993|NCT02298062|"~     The objective of this study is to investigate the effect of infliximab to the children who~     don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki~     disease.~   "
57994|NCT02298049|"~     To our knowledge no study has assessed the effects of a meal on neural responses to food~     cues and compared this with a condition simulating natural inter-meal hunger levels. This is~     important, as the existing literature often compares the effect of fasting to satiation,~     which may not reflect typical appetite processes. Thus, the purpose of this research was to~     examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen~     level dependent (BOLD) activity in the human brain, as measured using functional magnetic~     resonance imaging (fMRI).~   "
57995|NCT02298036|"~     To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely~     delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for~     health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.~      To optimise the delivery of CBT for health anxiety delivered remotely by systematically~     identifying and then acting on barriers and enablers to the intervention through a network~     of practice.~   "
57996|NCT02298023|"~     Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal~     stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients~     with supraspinatus partial thickness tear by ultrasonographic guided injection.~   "
57997|NCT02298010|"~     The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose~     stations and the relation between each metastasis and survival are to be analyzed by~     retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229)~     which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy~     with extended lymphadenectomy.~   "
57998|NCT02297997|"~     This study is to assess the impact on the prevention of sarcopenia after taking~     cetylpyridinium chloride targeting the patients of presarcopenia over the age of 60.~   "
57999|NCT02297984|"~     Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia,~     and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia~     inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury~     and is increased in brain after acute cerebral infarction in humans and experimental~     animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α~     concentrations in patients with acute ischemic stroke during the initial 96-h period after~     stroke and assessed the relation between them and the relation of them to prognosis of such~     patients with acute ischemic stroke.~   "
58000|NCT02297971|"~     When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of~     bleeding when it is continued peri-operatively have to be weighed against the risk of~     coronary artery thrombosis when stopped. This study aims to assess coagulation and~     thrombocyte function every other day in patients who are taking ticagrelor after coronary~     artery stents and discontinue therapy at the end of one year.~   "
58001|NCT02297958|"~     Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many~     patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for~     induced atypical response when is binding to Fas such as avoiding apoptosis and inducing~     cell motility.~   "
58002|NCT02297945|"~     The purpose of this prospective, international phase III/IV study is to assess the efficacy~     and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36~     weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free~     cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.~   "
58041|NCT02297438|"~     The study is designed to compare the clinical benefit following treatment with letrozole in~     combination with Palbociclib versus letrozole in combination with placebo in Asian~     postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior~     systemic anti cancer therapies for their advanced/metastatic disease.~   "
58003|NCT02297932|"~     Physical activity and exercise interventions in multiple sclerosis (MS) have received great~     attention most recently and there exists several randomized clinical trials (RCTs)~     addressing the outcomes associated with such intervention. The majority of such~     interventions have primarily focused on directly influencing disease processes (e.g.,~     inflammation, neurotrophic factors), the reduction of symptoms (e.g., fatigue, depression),~     improvement in physical functioning (e.g., gait, strength) or enhancing one's quality of~     life. To date, the evidence suggests that exercise intervention in MS holds anywhere from~     minimal to great promise depending on the outcome of interest. For some outcomes such as~     depression or cognition, findings are even less optimistic, being null, or inconsistent, at~     best. These inconsistent findings may be attributed to methodological issues such as use of~     subjective reports, lack of appropriate control group, poor compliance, and sample~     selection. The proposed investigation aims to address some of these issues by: (1) Obtaining~     objective measures of outcomes of interest (i.e., fatigue, cognition, and~     participation/activities of daily living [ADLs]) and; (2) assessing certain person-specific~     factors (e.g., personality) and intermediary factors that may be influenced by physical~     activity and indirectly result in improved outcomes (e.g., improvement in sleep and~     subsequent improvement in fatigue and/or cognition). Thus, the primary objective of the~     proposed investigation is to: (1) utilize innovative and objective measures of outcomes and;~     (2) obtain comprehensive assessment of intermediary variables (e.g., sleep) or~     person-specific characteristics (e.g., personality), which together may explain the~     inconsistent findings in the literature and has the following specific aims:~      To achieve these goals, individuals will complete a comprehensive assessment of cognition,~     person-specific factors, intermediary factors, physical fitness, and functional magnetic~     resonance imaging (fMRI) prior to and following a home based exercise intervention.~   "
58004|NCT02297919|"~     The purpose of this study to create an educational portal Genç (e) sağlık in an attempt to~     develop a healthy eating habit, increase physical activity and reduce sedentary behavior in~     order to prevent to overweight gain which is school-based approach in adolescents and there~     with also test the level of program information and the behavioral alterations of~     effectiveness.~   "
58005|NCT02297906|"~     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both~     adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic~     purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal~     atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when~     administered by the IN route using the MAD.~   "
58006|NCT02297893|"~     Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual~     dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as~     buttoning a T-shirt or hand-writing. The aim of the present research project is to~     investigate the effectiveness of a high intensity home based exercise intervention focusing~     on fine motor skills (HOMEDEXT), in patients with PD.~      Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization~     will be done by an independent biostatistician who will use a computerized randomization~     protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after~     intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks~     later, will be done to assess long-lasting effects. Assessments will be performed by~     investigators who are blinded for the intervention.~      Participants: One hundred and four out-patients with PD will be recruited who report~     specific difficulties in manual dexterity when executing ADL. Intervention: The patients~     will be allocated to either an intervention group (n = 52) or control group (n = 52). In the~     intervention group PD patients will exercise, over a period of four weeks, once/day during~     30 minutes a treatment with specific exercises for dexterity. The PD patients, who will be~     allocated to the control group, will exercise Theraband exercises.~      Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole~     Peg test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening~     for dexterity. Furthermore for ADL a modified version of the subscale II of the Movement~     Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used.~     Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements~     in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will~     be used.~   "
58007|NCT02297880|"~     Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or~     appetite, divergent opinions appear regularly both in the scientific literature and in the~     popular press. The goal of this study is to examine the effects of LCS containing beverages~     on appetite and intake in healthy individuals.~   "
58008|NCT02297867|"~     The aim of the investigators study was to investigate the safety and efficacy of autologous~     ADSCs for the clinical treatment of liver cirrhosis.~   "
58009|NCT02297854|"~     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's~     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech~     USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under~     Fasting conditions.~   "
58010|NCT02297841|"~     Determine the ability of the study material (personal lubricant) to cause sensitization by~     repeated topical application to the skin of humans under controlled patch test conditions.~   "
58011|NCT02297828|"~     The purpose of this study is to determine if the application of Boussignac continuous~     positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2~     ratio in morbidly obese patients undergoing gastric bypass surgery .~   "
58012|NCT02297815|"~     The purpose of this study is to identify and use patient centered outcomes to compare rates~     of treatment failure and the rate of adverse drug effects between narrow-spectrum and~     broad-spectrum antibiotics for the treatment of common acute respiratory tract infections~     (ARTIs) in children.~   "
58013|NCT02297802|"~     The purpose of this study is to provide access for a single patient to PD-0325901 who was~     previously enrolled in a phase I clinical trial.~   "
58014|NCT02297789|"~     Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective~     of this clinical investigation is to evaluate the usability and acceptance of the~     investigative mask, the effectiveness of the seal and headgear.~      The participant will be randomised to use either full face mask prototype 1 or 2 as~     according to the randomization log for 7 ± 3 days in home. The participant will then~     crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the~     investigators or the participants will be blinded to the study.~   "
58015|NCT02297776|"~     Prediction of clinical outcome after cardiac arrest is clinically important.Early~     prognostication after successful cardiopulmonary resuscitation is difficult, and there is a~     need for novel methods to estimate the extent of brain injury and predict outcome. In this~     study, the investigators will evaluate the plasma levels of microRNAs (miRNAs) and circRNAs~     after cardiac arrest and assessed their ability to prognosticate neurological outcome.~   "
58016|NCT02297763|"~     The purpose of this study is to evaluate the efficacy of low dose quetiapine for the~     prophylaxis of delirium in critically ill patients in medical intensive care unit.~   "
58017|NCT02297750|"~     The purpose of this study is to give doctors who perform Endoscopic Retrograde~     Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in~     order to examine the bile duct as quickly and safely as possible.~   "
58055|NCT02297256|"~     This study is a single-center, prospective randomized clinical study intended to compare and~     evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate~     (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral~     spinal fusion.~   "
58019|NCT02297724|"~     The ultimate goal of this project is to develop methods that allow informed decision-making~     on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In~     placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies.~     Although there is no specific correspondence between a single type of pathology and IUGR,~     the common result of these pathologies is placental insufficiency, which limits the~     maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR~     placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and~     inflammation in the villous and intervillous space (villitis). Thus one potential approach~     to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental~     transport. Based on the hypothesis that efficiency of oxygen transport is representative for~     overall oxygen and nutrition transport in placenta, the investigators propose to~     characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use~     it as an index for better stratification in the IUGR risk group. The investigators will also~     consider alternative MRI approaches such as structural, diffusion and spectroscopy~     measurements inside the placenta, which might reflect the state of placental transport and~     reveal the status of placental health.~      Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency~     from normal placenta transport with histopathology data of the placenta. 2) To correlate the~     MRI metrics that reflects placental insufficiency with fetal outcome~   "
58020|NCT02297711|"~     Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the~     inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh~     have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia.~     The results of the operative treatment from single centers are reported to be good to~     excellent in between 70 - 90% of patients with the most promising results reported using an~     open minimal repair (OMR) technique. There are no randomized trials comparing open versus~     laparoscopic techniques regarding time for recovery and relief of pain. The aim of this~     randomized study is to compare the effectiveness of OMR technique in local or spinal~     anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the~     treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being~     free from intractable groin pain during sports activity or daily work four weeks after~     surgery.~   "
58021|NCT02297698|"~     This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled~     phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our~     target study population is high-risk HER2-positive breast cancer patients. High-risk~     HER2-positive breast cancer patients are defined as:~      Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive~     neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four~     cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR.~      Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo~     surgery as a first intervention and are found to have ≥ 4 positive lymph nodes.~      Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a~     first intervention and are found to have 1-3 positive lymph nodes.~      Disease-free subjects after standard of care multi-modality therapy will be screened and~     HLA-typed.~   "
58022|NCT02297685|"~     Objective: The aim of this investigation was compare the effectiveness of transcutaneous~     electrical nerve stimulation (TENS) and interferential currents (IC) on chronic low back~     pain. Forty-eight patients diagnosed as having chronic low back pain were randomly assigned~     to three groups: control (sham electrotherapy; age 47 ± 8 years), interferential currents~     (IC; age 48 ± 8 years) and transcutaneous electrical nerve stimulation (TENS; age 48 ± 8~     years). Patients in all groups received 12 × 30-min sessions of the assigned treatment for a~     period of 4 weeks plus therapeutic exercises. Before and after the treatment, low back pain~     was measured using a 100-mm visual analogue scale and functional disability level was~     measured using the Rolland Morris Disability Questionnaire. Participants status was followed~     up 3 months after the end of the treatment.~   "
58023|NCT02297672|"~     Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well~     tolerated form of partial breast radiotherapy. This protocol aims to build on the initial~     experience and to further refine the technique and collect toxicity and cost data,~     especially in comparison to alternate forms of breast radiotherapy.~   "
58024|NCT02297659|"~     Damage control laparotomy (DCL) has proven to be a successful means to improve survival in~     severely injured patients.1-5 However, the consequences of not being able to close the~     fascia after the initial operation due to significant resuscitation leading to bowel and~     retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy~     and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC)~     contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias,~     enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use~     after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing~     for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or~     standard crystalloid solutions after DCL and compare the time to PFC, rate of successful~     closure, and rate of complications associated with an open abdomen. The current failure rate~     of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates~     using hypertonic saline.~   "
58025|NCT02297646|"~     The purpose of this study is to investigate the effects of carbohydrate intake on training~     efficacy and health parameters of an endurance training program in healthy adults.~   "
58026|NCT02297633|"~     This study through the long-term observation followed up for 2 years to find the change of~     the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the~     severity of COPD. Evaluate the differences of prognosis between the different oxidative~     stress level (according to the level of ROMs are divided into higher and normal phenotype).~     Explore the new oxidative stress evaluation index ROMs application value in COPD.~   "
58027|NCT02297620|"~     The objective of this survey is to confirm the safety of Suglat Tablets when used in the~     elderly.~   "
58056|NCT02297243|"~     The purpose of this study is to collect preliminary clinical data related to the safety and~     performance of the Sinopsys Lacrimal Stent.~   "
60868|NCT02260518|"~     The purpose of this study is to examine the impact of a lifestyle intervention on~     gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a~     usual care control group.~   "
58028|NCT02297607|"~     Patients undergoing an esophagectomy will be randomized to receive either (1) routine~     post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube~     feeding to continue in the hospital until the patient is taking adequate nutrition by mouth~     at POD#8, or upon discharge.~      Specific Aim 1 is to determine the occurrence of common complications and readmissions~     post-operatively between the two patient groups. The investigators hypothesize that routine~     use of tube feeding may reduce the occurrence of post-operative complications.~      Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects~     recovery and QOL after esophagectomy. The investigators hypothesize that routine~     post-operative supplementation will enhance patients recovery and QOL.~      For esophagectomy specifically, there is very limited literature evaluating the complication~     rate and QOL associated with the length of post-operative tube feeding and adequate~     nutritional requirements. Small randomized studies have not shown a benefit to routine tube~     feeding, although the numbers were very small, ranging from 12-70 per group. The~     investigators will randomize 200 patients for the purpose of this study.~   "
58029|NCT02297594|"~     The purpose of this study is to assess the safety, tolerability and PK of single and~     multiple ascending dose of AK0529 when administered orally in healthy subjects~   "
58030|NCT02297581|"~     The study will assess patients with at least one major AE related to treatment /~     hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to~     the usual care group.~   "
58031|NCT02297568|"~     This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to~     determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin~     D status of breastfed infant.~   "
58032|NCT02297555|"~     Obesity and metabolic syndrome (MS) are closely interrelated leading to increased mortality,~     mainly due to cardiovascular disease. In addition, some cancers are much higher when obesity~     is associated with metabolic syndrome. Bariatric surgery allows significant and sustained~     weight loss with marked improvement of MS. Considered too invasive, surgery is proposed to a~     small proportion of patients who could theoretically benefit. The ENDOBARRIER® device~     implanted endoscopically is an innovative approach developed for management of obesity in~     the non-surgical manner with benefits for improvement in MS already reported in literature.~   "
58033|NCT02297542|"~     This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a~     high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to~     define the key determinants of vaccine-mediated protection against influenza and how these~     immunologic mediators may be enhanced by vaccination with a newly approved high-dose~     influenza vaccine in older people~   "
58034|NCT02297529|"~     The study is a phase 3b, multicenter, open-label, single-arm study designed to provide~     expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected~     stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of~     Talimogene Laherparepvec.~   "
58035|NCT02297516|"~     The efficacy and safety, as well as subject satisfaction will be evaluated after single~     treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated~     combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane~     Skinbooster. Subjects will be followed for up to 18 months after initial treatment.~   "
58036|NCT02297503|"~     The efficacy and safety, as well as subject satisfaction will be evaluated after single~     treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated~     combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster.~     Subjects will be followed for up to 18 months after initial treatment.~   "
58037|NCT02297490|"~     The study will explore how allergy symptoms experienced during the grass pollen season~     compare to symptoms experienced in the Environmental Exposure Chamber (EEC).~      There are 2 treatments in this study. Both treatments are injected under the skin.~     Allergovit® Grasses works by helping the body's immune system get used to grass-pollen~     before the grass pollen season begins which may lead to decreased sensitivity and reduced~     allergy symptoms during the grass season. Placebo treatment does not contain grass pollen~     mixture, and is not expected to reduce allergic symptoms overtime.~   "
58038|NCT02297477|"~     This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic~     efficacy, safety, tolerability and pharmacokinetics of a three-day course of~     Atovaquone-Proguanil (AP) or a three-day course of Atovaquone-Proguanil combined with 3 days~     of Artesunate (ASAP) in patients with uncomplicated Plasmodium falciparum malaria at~     selected sites in Cambodia. Atovaquone-proguanil, soon to adopted as a first line~     antimalarial agent by the National Malaria Control Program (CNM) in Cambodia in provinces~     with confirmed multidrug resistance, will be given with or without artesunate (AS) as a~     directly observed, standard three-day fixed dose combination treatment to all volunteers~     enrolled. The efficacy and safety of both drug combination as well as evidence for in vivo~     and in vitro resistance to their components will be monitored during the treatment period.~     All volunteers will receive a single dose of 15mg of primaquine as recommended by WHO with~     the first dose of AP or ASAP to block the transmission of malaria to mosquitoes. Resistance~     to AP and ASAP will be assessed by a combination of clinical, pharmacologic, and~     parasitological parameters including genomic signatures of selection during careful weekly~     follow-up visits for 6 weeks. Investigators will also be able to evaluate the effects of~     primaquine on the sexual stages of malaria (gametocytes).~   "
58039|NCT02297464|"~     Contrary to popular belief, previous studies have demonstrated beneficial effects of whole~     egg consumption in modifying biomarkers indicative of a greater risk of coronary heart~     disease (CHD), chronic inflammation, and insulin resistance. The following study is designed~     to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an~     oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin~     sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that~     the consumption of 2 eggs per day will not negatively impact plasma lipids in a young,~     healthy population.~   "
58140|NCT02296138|"~     The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed~     dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on~     moderate to severe COPD exacerbation in patients with severe to very severe COPD.~   "
58141|NCT02296125|"~     To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth~     factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic~     Non Small Cell Lung Cancer~   "
58042|NCT02297425|"~     Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and~     pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with~     advance EGFRm NSCLC (del 19, L858R, +/- T790M). The resulting PF-06459988 dose selected from~     the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of~     food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD~     expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open~     label, multi-center single-arm study of PF-06459988 for the assessment of antitumor activity~     in patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M.~   "
58043|NCT02297412|"~     This randomized pilot trial studies how well minocycline hydrochloride works in reducing~     chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer~     undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may~     cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and~     toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the~     quality of life in breast cancer patients.~   "
58044|NCT02297399|"~     This trial will compare the tolerance to 2 different methods for colon cleansing before~     colonoscopy in diabetic patients.~   "
58045|NCT02297386|"~     The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT~     (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer.~     Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen~     by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in~     almost all prostate cancer cells. The investigators want to find out if we can find and~     monitor changes in cancer using a FDHT PET scan.~   "
58046|NCT02297373|"~     Patients with a history of blood clots are at risk of developing additional clots in the~     future. Doctors use a tool called a clinical decision rule to tell them how likely it is~     that a patient has a blood clot and if they should have further testing to look for the~     clot. This tool may cause doctors to over-diagnosis a recurrent clot because the symptoms~     may be left over from the previous clot. Correctly diagnosing a recurrent blood clot is very~     important since there are risks associated with both over-diagnosis and under-diagnosis. If~     a recurrent blood clot is missed (under-diagnosis) the patient is at risk of death from a~     clot in the lungs. If blood thinners are prescribed when they are not needed~     (over-diagnosis), the patient may have to take blood thinners for their lifetime and risk~     having serious bleeding.~   "
58047|NCT02297360|"~     The Viviscal Extra-Strength formulation is an oral food/dietary supplement specifically~     designed to promote hair growth for women suffering from temporary thinning hair. It does~     not contain hormones or drugs and has been marketed in Europe for over 15 years. Viviscal~     Extra-Strength is marketed as Viviscal Maximum Strength in some other territories.~      The hypothesis of this clinical research study is that the ingestion of Viviscal~     Extra-Strength over a three (3) month period will strengthen and promote the growth of~     terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair~     associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when~     compared to using the placebo tablet.~   "
58048|NCT02297347|"~     Newborn screening and early treatment prevent the most severe manifestations of~     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,~     slow processing speed, and visual-motor problems commonly occur. Many adults with this~     disorder also suffer depression and anxiety. In this study the investigators will examine~     adults with PKU on sapropterin dihydrochloride (Kuvan) treatment for PKU and compare their~     results to those of subjects with PKU not on Kuvan. Using magnetic resonance imaging (MRI)~     techniques, including novel MR spectroscopy (MRS) the investigators hope to discover why~     this distinct constellation of deficits occurs in PKU. Adult subjects with PKU will undergo~     a comprehensive MRI evaluations, including a novel method of MR spectroscopy to determine~     brain phenylalanine levels. In addition, participants will receive neurological and~     neuropsychological examinations and dietary evaluation.~   "
58049|NCT02297334|"~     The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary~     circuit attenuates the inflammatory response to extracorporeal circulation in patients~     undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood~     by the CytoSorb device significantly improves circulation and outcome in patients undergoing~     on-pump cardiac surgery.~   "
58050|NCT02297321|"~     This is a prospective study to evaluate the efficacy and safety of an accessory for laser~     tattoo removal in allowing multiple passes within a single treatment session.~   "
58051|NCT02297308|"~     This study is a retrospective, single center data collection to assess bleeding and vascular~     complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral~     Introducer is used for vascular access.~   "
58052|NCT02297295|"~     The purpose of this study is to determine whether exercise medicine in lower limb amputees~     has a impact on the three domains of the International Classification of Functioning of the~     WHO (function, activities and participation), and on quality of life.~   "
58053|NCT02297282|"~     Depression affects 15% of Canadians resulting in serious impact on health, ability to~     function including social, family and work related activities. Despite the several treatment~     options available for managing depression including medications, many patients do not~     respond to treatment and experience troublesome side effects. Psychotherapies are important~     in the treatment of depression and several options are currently being offered at the Mood~     Disorders Program (MDP), St. Joseph's Healthcare Hamilton. However a simple and reportedly~     effective therapy called Behavioural Activation (BA) is not currently available and existing~     evidence supporting its' effectiveness is limited to individual therapy of community based~     patients who are unlike the patients seen at the MDP who may have a more severe illness. The~     investigators are therefore planning to study the effectiveness of BA in patients with~     depression as an add on therapy to existing usual care compared to wait-list added to usual~     care. The study outcome is reduction in depressive symptoms and improvement in quality of~     life. The duration of therapy is 18 weeks and all adults with depression are eligible to~     participate.~   "
58054|NCT02297269|"~     Deep vein thrombosis (DVT) is a common complication of surgery, which could result in~     pulmonary embolism (PE). PE is a serious and potentially life-threatening syndrome. The~     purpose of this study is to investigate the impact of laparoscopic versus open surgeries on~     the incidence of postoperative DVT in patients with gastrointestinal malignancy~   "
58057|NCT02297230|"~     Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and~     Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to~     breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction~     to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly~     until surgery and as per standard of care after surgery for up to 1 year total.~      **Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical~     mastectomy within two months following discontinuation of pre-operative systemic therapy,~     contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time~     of surgery. Additional tissue samples will be collected from the surgical specimen for~     assessment of tumor molecular characteristics.~      ***All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2,~     cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide~     (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen~     as well or any alternative antihormonal therapy may be prescribed for five years for~     patients with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed~     for a total of 1 year since first dose as per standard of care.~   "
58058|NCT02297217|"~     This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a~     palliative course of external beam radiation treatment improves both dysphagia relief and~     patient quality of life in patients with unresectable esophageal cancer.~   "
58059|NCT02297204|"~     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-Diabetic Macular Edema). In addition, subjects~     who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.~   "
58060|NCT02297191|"~     The purpose of the study is to determine the effectiveness of a new approach to numbing~     (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on~     the skin of the back.~   "
58061|NCT02297178|"~     Urinary incontinences is a highly prevalent and distressing condition which has a~     significant impact on health related quality of life in millions of women worldwide. Of all~     women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have~     detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the~     International Continence society as Urinary urgency, with or without urge incontinence,~     usually with frequency and nocturia if there is a no infection or proven pathology (Abrams~     et al 2002)~      Initial management of OAB and DO consists of conservative measures such as altering fluid~     intake, bladder retraining and drug therapy. The next step consists of interventions such as~     cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder~     problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic~     benefit.~      The original study showed no benefit of urethral dilatation versus no dilatation at 6 months~     follow up (Duckett 2007). The investigators do not know the natural history of patients with~     voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what~     happens to these patients symptoms over time.~   "
58062|NCT02297165|"~     The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing~     environment, on the access at the autobiographical memories in anorexic patients.~   "
58063|NCT02297152|"~     The aim of study is to determine if they can produce increases in the IELT using a~     masturbator in subjects with premature ejaculation, producing improvements in the quality~     and satisfaction of the sexuality of the patient.~   "
58064|NCT02297139|"~     The purpose of this study is to continue to provide dasatinib to patients that are currently~     participating in another dasatinib trial that is ending and for which there is no other~     option to provide dasatinib.~   "
58065|NCT02297126|"~     The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients~     assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed,~     but not tested. It is randomized between an intervention arm and one that receives no~     intervention in order that the genotyped group can be compared with one in which~     undisturbed, routine clinical care is carried out in patients taking the same drugs. Both~     arms will be followed for a year after being prescribed a targeted medication. Patients~     randomized into the intervention arm that are prescribed one or more of the 24 targeted~     index medication will receive pharmacogenomic testing using a custom micro-array measuring~     51 Single nucleotide polymorphisms in 16 genes. The study is being conducted by the Indiana~     University School of Medicine and the Indiana University Institute of Personalized Medicine~     in collaboration with the Eskenazi Health System and will evaluate the economic and clinical~     outcomes associated with embedding a pharmacogenomics program in a system that serves as the~     primary health care safety-net in Indianapolis, Indiana. By successfully implementing a~     pharmacogenomics program and integrating it with the Electronic Health Record and Clinical~     Decision Support system, physicians will be able to optimize patient care by delivering~     tailored therapeutic decisions based on the patient's individual genetics.~   "
58066|NCT02297113|"~     All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department~     will be screened for inclusion in this clinical study. The indication of endotracheal~     intubation is an exclusively clinical decision and is not affected by this study protocol in~     any aspect.~      If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of~     two groups~        1. C-MAC Videolaryngoscope in appropriate size~        2. conventional endotracheal intubation using Macintosh Blade in appropriate size~      Randomization (1:1) will be based on computer-generated codes maintained in sequentially~     numbered opaque envelopes that will be opened immediately before randomization.~   "
58067|NCT02297100|"~     The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A~     in interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®,~     is a medication that comes from the bacteria Clostridium botulinum. It works by blocking the~     release of the neurotransmitter acetylcholine(a chemical messenger that carries signals~     between nerve cells and other cells in the body). Blocking that neurotransmitter results in~     decreased muscle activity.~   "
61925|NCT02246673|"~     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic~     (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to~     febuxostat administered alone in adult subjects with gout.~   "
58068|NCT02297087|"~     Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and~     enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the~     necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).~      Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical~     paradigm in the treatment of SCLC such that each individual patient would be treated with a~     single-agent or combination therapy of commercially available agents that relates to~     particular target(s) that have been identified via GWS.~   "
58069|NCT02297074|"~     The present study was carried out to determine the glycaemic index (GI), glycaemic load~     (GL), insulinaemic index (InI), appetite ratings and postprandial plasma concentrations of~     gastrointestinal hormones related to the control of food intake after the ingestion of five~     types of commercially available selected Spanish breads. All volunteers took the breads and~     glucose in a crossover interventional study.~   "
58070|NCT02297061|"~     Hip fractures are associated with a large hidden blood loss. That is, the total blood loss~     associated with hip fracture surgery is much greater than that observed intra operatively.~     There is currently no viable method of identifying patients at risk of transfusion. The on~     admission haemoglobin level has been shown to be falsely reassuring .~      We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG)~     is taken on admission. The results are blinded to clinicians. Results will be evaluated at~     the end of the study, comparing intra-operative and total blood losses with the TEG profile~     of the patient.~   "
58071|NCT02297048|"~     Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the~     urines. The investigators wonder whether progesterone or other adrenal hormon play the same~     role. The investigators will investigate surrenal hormone production in healthy subjects~     under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a~     renal loss of potassium.~   "
58072|NCT02297035|"~     Primary progressive aphasias (PPA) represent a challenging group of degenerative language~     diseases that has led to growing interest in the scientific and medical community. However,~     a full-blown cognitive/linguistic, anatomic and biologic characterization of the three main~     variants remains incomplete given that the available data derive from relatively small~     patient samples. Such a three-fold characterisation will be an major milestone with the~     prospective of providing the rationale for therapeutic interventions comprising specific~     rehabilitations protocols and pharmacological trials.~      The present study addresses theses issues in the three PPA main variants through a~     cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features,~     2) anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity -~     MRI resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).~   "
58073|NCT02297022|"~     The purpose of this study is to investigate the safety and efficacy of deep brain~     stimulation in obese patients with Prader Willi syndrome refractory to conventional~     treatment.~   "
58074|NCT02297009|"~     A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa.~     Samples will be taken from the same participant at different timepoints.~      DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit~     and will be quantified by a nano-drop spectrophotometer.~      We will determine global and gene-specific methylation and hydroxymethylation alterations by~     UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative~     measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS~     platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter~     genes, and genes involved in the oxidative stress pathways will be assessed by~     PCR-pyrosequencing.~   "
58075|NCT02296996|"~     Patients with BRAF V600 mutant advanced melanoma benefit from treatment with a~     BRAF-inhibitor (e.g. dabrafenib, vemurafenib) and from combination of a BRAF- and~     MEK-inhibitor (e.g. dabrafenib and trametinib). Following initial tumor regression,~     progression is diagnosed in a majority of patients treated with BRAF-inhibitor mono-therapy~     within the first 12-months of therapy. Various molecular mechanisms that underlie the~     development of resistance to treatment with a BRAF-inhibitor have been reported. These~     mechanisms do not include secondary mutations in the BRAF-gene and therefore resistance to~     BRAF-inhibition could potentially be reversible when selective pressure by BRAF-inhibition~     is withheld for a sufficient period of time of melanoma progression. This clinical trial~     protocol addresses the potential renewed anti-tumor activity of combined BRAF- and MEK~     inhibition with the combination of dabrafenib and trametinib in patients with unresectable~     AJCC stage III or - IV BRAF V600 mutant melanoma who are documented with progression of~     disease at least 12 weeks following the last day of dosing of a BRAFinhibitor containing~     treatment regimen.~   "
58076|NCT02296983|"~     Previous Ebola outbreaks have been limited to individual countries and contained by~     infection control activities. The current outbreak in West Africa is international, and air~     travel has resulted in a number of infected travellers crossing national borders. There are~     currently no specific treatments generally available for Ebola and the mortality is high,~     particularly in countries with limited intensive care facilities. There is currently no~     vaccine and the personal protection required by healthcare workers treating patients is~     cumbersome and requires full compliance to be protective.~      There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon,~     Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which~     this study will be conducted. The investigators are conducting this trial, a Phase I,~     open-label, dose escalation trial, designed to establish safety, tolerability and~     immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first~     time in sub-Saharan African populations.~      The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at~     the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be~     the primary target population as they are likely to be the recipients of a protective~     vaccine. The investigators will vaccinate a cohort of 20 volunteers at a low dose and then~     vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one~     dose of the vaccine. The investigators will follow them up for a period of one year looking~     to their safety and immunogenicity endpoints.~   "
58077|NCT02296970|"~     Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell~     carcinoma (BCC) without the need for a follow up surgical procedure.~   "
58078|NCT02296957|"~     Brief Summary~      Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely~     prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce~     sleep disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a~     hospital stay. These hospital-induced sleep disorders should spontaneously disappear after~     discharge and, because of their potential impact on falls, hip fractures, psychiatric side~     effects and induced dependence, hypnosedative drugs should therefore be discontinued at~     discharge in these naïve-treated patients. Adhesion to this recommendation is poor. Recent~     and on-going research on this topic mostly concerns adverse effects although these are~     already substantially documented and evidence-based, while there is a poor interest on~     developing research on potential strategies susceptible to practically improve the current~     adhesion to recommendations.~      Design and objectives. This project proposes multi-component intervention and is directed~     towards hospital prescribers, patients, and their general practitioner. It aims at~     discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during~     hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention,~     as compared to usual care management, will be estimated in a multicentre (6 hospitals~     gathering 8 centres: 5 internal medicine departments, 3 cardiology departments) randomised,~     cross-over, two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4~     hospitals will gather only 1 centre (4x1 centres). An equilibrated randomization will be~     applied to the 8 centres, making sure that, in hospitals gathering 2 centres, these 2~     centres will apply the same strategy in a given period and that the 2 hospitals will apply~     alternative strategies. This randomisation is set up to avoid the risk of a potential~     contamination between the 2 strategies from one centre to the other within the same~     hospital. As a result, 3 hospitals (including 4 medical departments) will apply the~     intervention during the first 11-month period, while the 3 others (including 4 medical~     departments) will apply usual care during this period, as a result of an equilibrated~     hospitals randomization. During the second 11-month period, each hospital will apply the~     alternative management. The two periods will be separated by a 1-month wash-out period.~      In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group~     and 120 in the usual care group).~      Patient follow-up duration will be 12 months after discharge. Patient status in regards with~     quality of sleep (study primary objective), hypnosedative consumption and frequency of falls~     (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after~     discharge.~      Expected results. The results of the study should contribute to guide research and public~     decisions to practically decrease hypnosedative prescription and consumption, and associated~     adverse events.~   "
58079|NCT02296944|"~     This study is a retrospective cohort of patients minors during the operation of cartilage~     tympanoplasty for tympanic membrane perforation~   "
58080|NCT02296931|"~     Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted~     and relatively inexpensive treatment for these conditions, barriers to delivery via IV~     injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP~     is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the~     delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to~     deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi.~      AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to~     the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure~     proper procedures are followed. Phase 1 will be an initial validation of the clinical~     performance of the device delivering only standard IV saline to 10 stable women. The study~     will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting~     with symptoms of pre-eclampsia.~        1. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP~          use.~        2. Eligible and willing participants will provide informed consent. Then, baseline~          demographic and relevant medical history information will be collected.~        3. In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse~          will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and~          record device performance and treatment specifications.~        4. Subsequent maintenance doses of saline or MgSO4 will be administered and observations~          monitored and recorded for up to 24 hours as clinically indicated.~      Others may benefit from this study in the future as AutoSyP is a new delivery system is~     needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The~     results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the~     College of Medicine Library, the Department of Paediatrics, and other partners working in~     neonatal and child health. Findings will be published in academic journals and conference~     proceedings in an effort to disseminate results to potential end-users. The research~     findings of this study will be critical in the evaluation of future interventions.~   "
58081|NCT02296918|"~     To evaluate the safety and preliminary efficacy of acalabrutinib in combination with~     obinutuzumab in 2 separate cohorts of patients.~   "
58082|NCT02296905|"~     This is an open-label, single-dose study designed to assess the pharmacokinetics and safety~     of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to~     those in subjects with normal hepatic function.~      Twenty-four subjects will be selected and enrolled according to the subject selection~     criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with~     moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic~     hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).~   "
58083|NCT02296892|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open label arm for~     midazolam, in patients undergoing a bronchoscopy.~   "
58084|NCT02296879|"~     Mesenchymal epithelial transition factor (c-MET) is a receptor tyrosine kinase that, when~     engaged by its ligand hepatocyte growth factor (HGF), has been implicated in various~     cellular process including development as well as oncogenesis.~      SAIT301 is a novel humanized monoclonal antibody targeting the alpha chain of extracellular~     domain of c-MET. Binding of SAIT301 to c-MET blocks HGF binding and inhibits HGF-mediated~     signaling. Furthermore, SAIT301 also induces efficient c-MET internalization from the cell~     surface and subsequent degradation, resulting in inhibition of growth of the c-MET addicted~     cancer cells.~      The sponsor decided to enroll subjects with tumors that express c-MET (by~     immunohistochemistry [IHC]) for this study, as the subjects with no c-MET expression are~     unlikely to benefit from SAIT301 treatment.~      Stage 1 of this Phase I study is designed to evaluate the safety, tolerability,~     pharmacokinetic (PK) profile, and anti-tumor activity of SAIT301 administered as a single IV~     infusion in 21 day cycles, for up to 4 cycles. Subjects without evidence of tumor~     progression after 4 cycles will be eligible to continue on SAIT301 treatment if there is no~     evidence of tumor progression for a further 4 cycles (Cycles 5 to 8). Biomarkers related to~     SAIT301 and/or tumor response will also be evaluated.Stage 2 will further evaluate the~     safety and PK profile of SAIT301 in select types of cancers. Dosing frequency may be~     adjusted based on the PK profile obtained during Stage 1.~   "
58085|NCT02296866|"~     The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin~     has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes~     in non-fasting patients undergoing emergency trauma surgery.~   "
58086|NCT02296853|"~     This study will evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and~     it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in~     participants with normal hepatic function and severe hepatic impairment.~   "
58102|NCT02296632|"~     This study aims to provide preliminary evidence of the validity of a sensor-based assessment~     of rheumatoid arthritis (RA) symptoms, and to collect structured qualitative feedback from~     RA Enbrel patients regarding the potential of a future biosensor/PRO mHealth application.~     The investigators' overarching hypothesis is that if patients have better and more timely~     information about whether Enbrel is working, then they will become more empowered and~     engaged in their treatment, more curious about how it may - or may not - be working, and~     potentially more compliant with therapy. However, this hypothesis remains largely untested.~   "
58087|NCT02296840|"~     Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric~     population in the United States. It is generally a well-tolerated procedure with~     post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following~     adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or~     re-admission to the hospital. Post-operative analgesia is most commonly managed with~     narcotic-containing pain medication. In recent years however, there is evidence that some~     patients may manifest increased sensitivity to narcotics, resulting in life-threatening~     respiratory compromise. Though there is a theoretical risk that nonsteroidal~     anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,~     evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains~     inconclusive for these generally well-tolerated medications. The goal of this study is to~     determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs~     in the management of post-operative pain following pediatric adenotonsillectomy, versus more~     commonly used narcotic pain medication. The study design will be an initial retrospective~     study to collect pilot data on the incidence of postoperative hemorrhage and indicators of~     adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This~     will be followed by a prospective, randomized, single-blind controlled study in which~     orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone~     (control intervention) in the postoperative period following adenotonsillectomy.~   "
58088|NCT02296814|"~     Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to~     placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the~     nasal and paranasal sinuses).~   "
58089|NCT02296801|"~     This study will look at effects the combination of palbociclib and letrozole may have on~     estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative~     breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine~     therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal~     women with ER-positive/HER2-negative breast cancer.~   "
58090|NCT02296788|"~     In the present study, we seek to elucidate the effects of aerobic exercise on fecal~     microbiota following the aforementioned no exercise control group and two doses of aerobic~     exercise training (the exercise training spans ~24 wks) in a cross-sectional sample.~   "
58091|NCT02296775|"~     This study will compare the plasma pharmacokinetic profile and the change in disease~     activity score in patients with active rheumatoid arthritis following treatment with two~     1000 mg doses of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients~     will also be monitored for safety, B cell depletion and recovery, and for the development of~     immune responses to the administered study drugs~   "
58092|NCT02296762|"~     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited,~     India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,~     adult,human subjects under Fed conditions.~   "
58093|NCT02296749|"~     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited,~     India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,~     adult,human subjects under Fasting conditions.~   "
58094|NCT02296736|"~     Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic~     head malignant tumours and to predict the resectability based on the preoperative imaging.~     To achieve this, a retrospective review of the preoperative CT scans will be conducted for~     all patients with pancreatic head malignancy treated at the Peninsula~     Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.~   "
58095|NCT02296723|"~     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's~     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech~     USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed~     conditions.~   "
58096|NCT02296710|"~     The investigators evaluate the changes of echocardiographic and sleep apnea parameters after~     mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before~     surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep~     apnea control and the results are evaluated.~   "
58097|NCT02296697|"~     Patients admitted in the Emergency Service that have pressure ulcers will be selected by~     eligibility criteria and randomized into three groups according to the adopted therapy:~     wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound~     dressing + low-level laser therapy group (GLBP).~   "
58098|NCT02296684|"~     The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve~     locoregional recurrence and distant metastatic rates in high-risk patients with locally~     advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current~     standard of care surgical approaches.~   "
58099|NCT02296671|"~     In this study the investigators aim to: 1) confirm the objective response rate (ORR)~     observed in the investigators initial study for patients with the TSER*2/*2 genotype 2)~     determine whether PEMOX regimen is more worthy of future development for this patient~     genotype selected population than FOLFOX based on the data indicating that pemetrexed may be~     a better TS targeted agent than 5-FU.~      Patients who are homozygous for the TSER*2 allele (TSER*2/*2) will be able to continue in~     the study and will be randomized. Patients with other TSER genotypes will not be included~     and will be considered screen fails.~      The first 8 patients with the TSER*2/*2 genotype will be randomized 1:1 to receive treatment~     with either PEMOX or FOLFOX (4 in each group).~      Analysis of the objective response rate (ORR) in each treatment arm will occur after the~     first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will~     be preferentially assigned to the better performing treatment arm based on continuous~     real-time reassessments of ORR results.~   "
58100|NCT02296658|"~     The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of~     intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with~     pathologically positive lymph node after completely resected gastric cancer. Furthermore,~     the investigators sought to compare the dosimetric differences between the~     volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy~     (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.~   "
58101|NCT02296645|"~     This is a randomized, paired-comparisons design where each subject receives two of the~     planned treatments.~   "
58108|NCT02296554|"~     Biceps Tenodesis is currently advocated for older, less active patients, but to date is not~     often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young,~     active patients. The ideal surgical management for this pathology is not clearly known. More~     surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young,~     active population. If this study were to demonstrate that biceps tenodesis is similar to or~     better than SLAP repair, this would fundamentally change the treatment of SLAP tears.~     Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier~     return to activities for patients with this pathology.~   "
58109|NCT02296541|"~     The purpose of this study is to evaluate the safety and immune response to three DNA~     vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in~     healthy, HIV-uninfected adults.~   "
58110|NCT02296528|"~     Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used~     in medicine. While great progress in biomedical devices has been made for many other~     disorders, there is currently no device available to assist with the act of deglutition. The~     investigators have developed a biomedical device (Swallow Expansion Device, SED) that~     assists with swallowing by mechanically opening the upper esophageal sphincter and allowing~     food and liquid to safely enter the esophagus. The SED has proven safe in cadaver and live~     animal studies (Belafsky, 2010).~   "
58111|NCT02296515|"~     Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective~     comparison study in patients undergoing regular intrathecal pump refill~   "
58112|NCT02296502|"~     The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum~     Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for~     ASD and 150 children and adolescents referred for diagnosis who do not meet DSM-IV-TR~     criteria.Families and children will be recruited from eight sites affiliated with the Autism~     Treatment Network (ATN). Participants must be between the ages of 2.0 and 17.11 years who~     undergo an ATN assessment at one of the eight sites. Both subjects who are found to meet~     criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment)~     will be enrolled. After completing the standard ATN assessment, clinicians will complete a~     DSM-IV and DSM-5 checklist for ASD/PDD.~   "
58113|NCT02296489|"~     Asthma is a common chronic disorder of the airways characterized by periods of reversible~     airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by~     chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed~     airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to~     become life-threatening events. Severity of asthma exacerbation is assessed through medical~     history and lung function measurements with Spirometer and requires full cooperation of the~     patient. Thus, in uncooperative populations or during emergency medical situations the~     spirometer cannot be used. As an alternative, capnography data has been proposed as an~     indicator of bronchospasm in asthma. Previous studies found correlations between the~     capnography parameters and methacholine challenge in asthma patients. However, the~     relationship between capnography parameters and severity of asthma or severity of asthma~     exacerbation have not been well characterized. The study hypothesis is that within the~     clinical population that is invited to do the methacholine challenge, a different waveform~     pattern in asthma patients will be detected and possibly a correlation between the severity~     of obstruction and pattern of waveform during the methacholine challenge. In this proposed~     feasibility observational study, sixty subjects, both men and women, who will be invited to~     participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin~     Medical Center, will be recruited to the study. Respiratory information will be recorded~     using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine®~     Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the~     methacholine challenge.~   "
58114|NCT02296476|"~     Open-label, phase IIa, non-randomized, multicentric study of single-agent OTX015 in~     recurrent GBM (glioblastoma Multiforme) patients after standard front-line therapy failure.~      The first study step (dose escalation) will determine the maximum tolerated dose (MTD) using~     standard 3+3 dose escalation enrolling 3 patients per OTX015 dose level (DL), with an~     additional 3 patients to be enrolled at the first occurrence of dose-limiting toxicity~     (DLT). MTD assessment will be based on the tolerability observed during the first 28 days of~     treatment.~      The second study step (expansion cohort) will assess OTX015 efficacy as measured by the~     progression-free survival rate at 6 months (PFS-6) in recurrent GBM patients as assessed by~     local investigators and confirmed by an independent central review committee. A two-stage~     design is used in this step to allow for the possibility of stopping the trial early for~     lack of efficacy.~   "
58115|NCT02296463|"~     This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and~     female subjects ≥24 months of age and <72 months of age. Subjects will be without~     symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be~     screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and~     will be excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).~      Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM~     dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and~     in one group placebo) will be used to maintain the study blind; all subjects will receive a~     complete course of hepatitis A vaccine as a study benefit.~   "
58116|NCT02296450|"~     The purpose of this study is to see how skin conditions that are related to different kinds~     of cancer or cancer treatments affect a patient's overall well-being. Skin conditions are~     common in cancer patients and survivors. Sometimes, the skin condition is directly related~     to the cancer. Other times, these conditions are a side effect of cancer treatment. Patients~     in the study will be asked to fill out at least one questionnaire about how they feel about~     their skin condition. If the patient needs to be treated for their skin condition, they will~     be asked to complete the same questionnaire when they return for a follow-up visit. The~     investigators hope the study will improve our understanding of how cancer patients feel~     about their skin conditions. They also hope this study helps them learn how to improve the~     way we treat skin conditions in cancer patients.~   "
58142|NCT02296112|"~     This phase II trial studies trametinib in treating patients with melanoma with v-Raf murine~     sarcoma viral oncogene homolog B (BRAF) non-V600 mutations that has spread to other places~     in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
58117|NCT02296437|"~     Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective.~     However, patient concerns with cognitive side effects have encouraged trials of new,~     non-convulsive forms of mild brain stimulation such as transcranial Direct Current~     Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant~     effects and is safe, painless and well tolerated. However, not all patients may have an~     adequate response, raising the need to find ways of optimising efficacy. This clinical pilot~     study will examine the feasibility and safety of combining tDCS with a cognitive training~     task which engages the same brain region targeted by tDCS for treatment of depression.~   "
58118|NCT02296424|"~     The purpose of this study is to evaluate the efficacy observed with canakinumab dose~     reduction in a subgroup of patients in the extension study CACZ885G2301E1.~   "
58119|NCT02296411|"~     The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF~     5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as~     well as to assess its safety.~   "
58120|NCT02296398|"~     Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T~     cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS),~     the leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical~     manifestations and prognosis are highly variable. Improving the management of this incurable~     disease with limited toxicity is the main point of the current research. Romidepsin is a~     well-tolerated histone deacetylase inhibitor which has demonstrated activity against~     advanced stages of CTCL. In November 2009, it was approved by the US Food and Drug~     Administration (FDA) for the treatment of CTCL in patients who have received at least one~     prior systemic therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is~     said that it should be continued as long as the patient receives benefit and tolerates the~     drug. We experienced in our clinic that a long-term (>6 months) use of Romidepsin, even with~     spared doses allows patients to maintain disease in complete remission or under control~     without severe side effects. We aim to demonstrate how many patients have benefited of this~     maintenance therapy, and detect the side effects related to the long-term use of Romidepsin,~     as well as characterize those patients that can get benefit of this therapy.~   "
58121|NCT02296385|"~     To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil~     supplements) depending on genotype of relevant factors in lipid metabolism~   "
58122|NCT02296372|"~     Critically ill patients are on high risk for increased serum glucose levels, leading to more~     comorbidity and higher mortality risk. In patients with severe sepsis and septic shock~     hyperglycemia is a typical finding. However the need of insulin therapy is associated with~     an increased risk of hypoglycemia. Newly developed technologies for continuous glucose~     monitoring in critically ill patients may improve glycemic control and reduce glucose~     variability. The investigators will perform continuous glucose monitoring in critically ill~     patients on ICU. Measurements will be done for a period of 72h per patient. The~     investigators aim is to evaluate accuracy feasibility and acceptance of these methods. To~     analyze accuracy sensor glucose levels will be validated due to arterial blood gas~     measurements with the blood gas analyzer. The investigators will investigate the influence~     of several factors like oedema, perspiration, BMI, body temperature, pH-value application of~     vasoconstrictors on accuracy and feasibility of the particular system. Furthermore Nursing~     staff will be given a questionnaire to identify acceptance.~   "
58123|NCT02296359|"~     Respiratory viruses are known to be risk factors for asthma (e.g respiratory syncytial~     viruses, RSVs, and Human Rhinoviruses, HRVs, may induce bronchiolitis, and wheezing~     illnesses respectively). The common flu is also known to be a risk factor and the Centers~     for Disease Control and Prevention (CDC) recommends that asthmatics receive the annual flu~     vaccine, as a high-risk group for related asthma exacerbations. The investigators will be~     evaluating the variation in individual responses over time after controlled immune~     activation following influenza vaccination of monozygotic twins, both discordant for asthma,~     and concordant non-asthmatic. The transition from initial healthy to immune-system activated~     physiological states post vaccination will provide unprecedented molecular (omics) data on~     the molecular dynamics of immune response to vaccination, and novel insight into the flu~     response. The investigators will infer novel networks and pathways and as well as the~     dynamics of genes and mechanisms involved in asthma, flu vaccination, and individual~     responses, and correlate them to evaluated personalized genetic risks in the same study. The~     investigators will be able to also contrast the vaccination response in asthmatic and~     non-asthmatic individuals, in a longitudinal approach which has never been performed before~     using multiple-omics that included an immunization response.~   "
58124|NCT02296346|"~     In this research study, the investigators will determine whether a procedure called~     Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in~     people with SPMS when compared to monthly corticosteroid infusions. This study will~     determine whether ECP has an effect on inflammatory cells in people with SPMS and whether it~     has a beneficial therapeutic effect.~   "
58125|NCT02296333|"~     The purpose of the study is to determine whether the effect of ondansetron on the analgesic~     effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of~     acetaminophen and also reduce opioid consumption~   "
58126|NCT02296320|"~     Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused~     by Staphylococcus aureus in high-risk patients.~   "
58127|NCT02296307|"~     This study hopes to improve early detection of ovarian cancer. It will determine if women~     with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency~     and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer~     biomarker and transvaginal ultrasound.~   "
58128|NCT02296294|"~     This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device~     called Body Composition Monitor (BCM) which measures the body composition (i.e. the water~     content of the body).~      Specifically, the investigators will evaluate the use of BCM for correct detection of~     intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we~     will test the change over time of the volunteers´ volume status after an intravenous fluid~     therapy.~   "
58129|NCT02296281|"~     The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to~     treat grade 2 or above radiation-induced lung injury patients.~   "
58130|NCT02296268|"~     Stroke is a leading cause of chronic disability here in Nova Scotia and globally. Aerobic~     exercise is known to improve health by increasing energy levels, physical mobility, balance,~     bone health, cardiovascular risk reduction, mental well-being, cognition, sleep, and quality~     of life. Nonetheless, people remain woefully inactive after stroke, regardless if they are~     in hospital or at home. The current investigative team and others have shown that even~     during physiotherapy, exercise intensity is not adequate to increase physical fitness.~     Consequently, patients are often deprived of a treatment that could improve their recovery.~     Why does this gap between evidence and clinical practice persist? Through a national survey~     the current team found that an important contributing factor is lack of appropriate~     screening (especially stress tests) to ensure that patients are safe to engage in aerobic~     exercise. This project is designed to close this evidence-practice gap by establishing a~     state-of-the-art aerobic exercise screening and prescription clinic at the Nova Scotia~     Rehabilitation Centre (NSRC). The intent is to compare outcomes of stroke rehabilitation~     participants before and after the clinic is underway and determine if the clinic has a~     positive effect on the confidence of NSRC physiotherapists to use aerobic exercise safely~     and effectively in stroke rehabilitation.~   "
58131|NCT02296255|"~     The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old~     women at the time of their first access to cervical cancer screening, to understand the~     impact of vaccination on screening activity; to evaluate the immune response following~     vaccination; to study the dynamics of the infection after vaccination, including the~     possible change in the frequency of non-vaccine HPV types, to evaluate cytological~     abnormalities reductions in vaccinated women and to assess if HPV test in urine sample could~     be a useful non-invasive method to monitor HPV status in younger women.~   "
58132|NCT02296242|"~     This study is being performed to assess the safety, tolerability, and preliminary clinical~     effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute~     Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).~   "
58133|NCT02296229|"~     This clinical trial studies stereotactic body radiation therapy in treating patients with~     high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the~     body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a~     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause~     less damage to normal tissue. Studying quality of life in patients undergoing stereotactic~     body radiation therapy may help identify the long-term effects of treatment on patients with~     prostate cancer.~   "
58134|NCT02296216|"~     Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy~     can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several~     studies reported long-term extra-pituitary side-effects of conventional radiotherapy.~     However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a~     highly precise stereotactic technique, that has been used as an effective treatment of~     acromegaly.~      Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary~     side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.~      Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma~     Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas~     unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for~     at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in~     terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits~     and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.~      Expected results: We should be able to determine whether Gamma Knife radiosurgery is a~     long-term safe technique. This result might modify the management and follow-up of patients~     with acromegaly unsuccessfully treated by surgery.~   "
58135|NCT02296203|"~     This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type,~     irinotecan-resistant metastatic colorectal cancer patients progressing after an initial~     response to a first-line cetuximab-containing therapy, receive a rechallenge third-line~     treatment with cetuximab plus irinotecan.~   "
58136|NCT02296190|"~     The primary objective of this study is to demonstrate the superiority of at least 1 dose of~     intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an~     electrophysiology (EP) laboratory.~   "
58137|NCT02296177|"~     Breast cancer is the most common cancer and the second leading cause of cancer related death~     in American women. Regular screening, early diagnosis, and timely treatment initiation have~     been shown to reduce breast cancer morbidity and mortality. However, disparities continue to~     exist across the breast cancer continuum for underserved women, particularly minority women.~     The reduction of disparities in breast cancer outcomes is a major goal of Healthy People~     2020 and the National Cancer Institute. However, the preventable burden of late stage breast~     cancer will continue until the investigators close the gap between what is known about~     prevention and what is implemented in the community. Although many sources of information~     exist about theory and [theory-] and evidence-based interventions (EBIs) to promote~     mammography screening, their adoption and use in the community has been limited and~     haphazard at best.~   "
58138|NCT02296164|"~     The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study~     that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor.~     Patients will be followed prospectively for a maximum of 1 year from the date of signed~     informed consent (enrollment) until end of study. Continuation in the study is not~     contingent on continuation of Valchlor.~   "
58139|NCT02296151|"~     The primary objective of this study is to determine if a more specific exercise routine that~     incorporates a progressive hip stability program will help to rehabilitate the hip and~     reduce symptoms of iliotibial band syndrome more than conventional hip exercises. Three~     different exercises interventions will be compared to determine its effectiveness in~     reducing pain, improving function and returning subjects to running symptom free. Secondary~     objective for this study is to establish an intervention program for female runners with~     this injury. There will be three treatment arms and participants will be randomly assigned~     to one of three groups: Group A- control (stretching), group B (conventional hip exercises~     and group C (experimental treatment- specific progressive hip exercises).~   "
58143|NCT02296099|"~     The purpose of the study is to determine if the administration of liposomal bupivacaine at~     the completion of a suburethral sling procedure will result in decreased postoperative pain~     compared to no injection.~   "
58147|NCT02296047|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity,~     mortality and disability throughout the world, leading to a heavy social and economic~     burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to~     reduce dyspnea, improve exercise tolerance and improve health status. However,conventional~     lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in~     one second (FEV1) frequently fail to detect significant functional responses to~     bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical~     and scientific reasons to develop a new tool to objectively assess the effect of different~     treatments including bronchodilator on COPD. Our previous study showed that~     Ventilation-drive coupling may be more sensitive and accurate to evaluate the efficacy of~     inhaled bronchodilators in patients with COPD because it could better reflect the~     pathological and physiological characteristics of COPD.~      Based on the above conclusion, the present study were performed using the experimental~     methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive~     coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable~     basis for the clinical application of this index.~   "
58148|NCT02296034|"~     The purpose of this study is to measure blood glucose variation in youth prior to and after~     participation in a healthy lifestyle intervention program. The hypothesis is that youth with~     more severe obesity and those further along in puberty will have more glycemic variability,~     and that glycemic variability will be improved by participation in the lifestyle~     intervention program.~   "
58149|NCT02296021|"~     This study aims at evaluating efficacy and safety of berberine-containing quadruple~     therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing~     quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori~     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior~     to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status~     will be randomized to one of the treatments described above. At week 2 and 6 follow-up~     visits, a urea breath test(UBT) will be performed to confirm eradication.~   "
58150|NCT02296008|"~     3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function~     and 3D topographic picture of pressures along the anal canal.~      Until now, it has been used only in adult population to evaluate defecatory disorders.~      Congenital anorectal disorders are severe conditions and may present wide spectrum of~     symptoms from gastrointestinal tract.~      The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal~     disorders such as Hirschsprung's disease and anorectal malformations.~      It may help for better understanding of pathophysiology of anorectal area and allow for~     planning improved procedures in these patients.~      Moreover, the investigators study may elucidate the real usefulness of the procedure in~     management of disorders of gastrointestinal tract in pediatric population.~   "
58151|NCT02295995|"~     The purpose of this study is to examine whether posttraumatic stress disorder (PTSD)~     symptoms impact adherence to a 12-week physical activity program and whether exercise can~     help improve PTSD symptoms and health outcomes in older Veterans. Forty Veterans over the~     age of 60 with PTSD will be recruited to participate in a 12-week physical activity program~     consisting of aerobic and strengthening activities. Participants will be randomized to an~     intervention arm or usual care wait-list control.~   "
58152|NCT02295982|"~     The purpose of this study is to describe the postoperative outcomes after laparoscopic~     transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy~     with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit~     of our experiences from the previous study to optimize the postoperative outcomes.~   "
58153|NCT02295969|"~     Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days~     of treatment.~   "
58154|NCT02295956|"~     The goal of this research study is to learn if it is possible to start a home-based exercise~     and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer~     before surgery (pre-operative rehabilitation, also known as prehabilitation).~   "
58155|NCT02295943|"~     The macular hole formation takes place in the centre of the retina. A closure of the macular~     hole is believed to take place if the central retinal area is kept dry in the postoperative~     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the~     supine position in the first postoperative days. The investigators have developed a~     positioning measuring device which can measure the extent of supine positioning time.~     Patients are to carry the positioning measuring device during the first postoperative 24~     hours. Hereby the investigators search new knowledge concerning patients compliance and its~     relation to macular hole closure.~   "
58156|NCT02295930|"~     This is a phase II randomized study of 4-months induction first-line chemotherapy with~     FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients~     affected by KRAS wild type (wt) mCRC.~   "
58157|NCT02295917|"~     The investigators aim to evaluate the width of the endometrial myometrial zone in~     participants during natural menstrual cycle by using specific computerized application on 3~     dimensions sonographic images of their uteri.~   "
58158|NCT02295904|"~     Video documentation of vaginal deliveries to evaluate the impact of the support of the~     perineum~   "
58159|NCT02295891|"~     Primary hyperhidrosis is a pathological condition characterized by the idiopathic and~     excessive secretion of sweat beyond normal physiological demand and is localized at~     particular foci such as the face, axilla, palms of the hands, and soles of the feet.~     Patients seeking medical attention for hyperhidrosis often report disruptions to their~     professional and/or social lives due to sweating and subsequently experience many~     psychosocial difficulties, such as anxiety, social phobia, and depression. Therefore, a~     psychiatric explanation of causality is frequently offered for these patients during~     diagnosis. Excessive sweating is often mistakenly interpreted as a symptom of an anxiety~     disorder and can be cause for social embarrassment, exacerbating emotional stress and social~     avoidance. As currently constituted, the treatment of secondary psychosocial symptoms in~     primary hyperhidrosis is poorly understood and requires further investigation.~   "
58183|NCT02295579|"~     From the earlier studies the investigators have treated women with bacterial vaginosis and~     cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10~     days for 2 month. The investigators will continue to follow them and investigate if~     treatment with lactobacilli every week for 6 month will increase cure rate.~   "
58160|NCT02295878|"~     Cardiovascular disease (CVD) is currently the leading cause of death worldwide.~     Epidemiologic studies have shown a diet rich in plant food protects against chronic~     degenerative diseases especially cardiovascular disease. Many of these studies have~     highlighted a potential role for phenolic compounds, which are abundant secondary plant~     metabolites, and which provide antioxidant and anti-inflammatory properties and are~     increasingly being shown to have an important role in influencing critical cell signalling~     pathways. A less well known, but nevertheless rich source of polyphenolic compounds is~     seaweed. In Ascophyllum nodosum, a common brown alga in the British Isles, polyphenols have~     been reported to comprise up to 14% of the dry weight of the plant. Some studies suggest~     that the potential antioxidant and anti-inflammatory benefits of seaweed-derived polyphenols~     may yield highly bioactive components with commercial potential for food and pharma~     applications. Preliminary work in our laboratory has revealed potent antioxidant activity of~     Ascophyllum nodosum extracts.~      Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design~     study is to investigate the biological activity of a food grade seaweed polyphenol extract~     in terms of reducing oxidative damage to DNA, modulation of inflammatory responses and~     reduction on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged~     30-65 years) will be randomised to receive either a capsule containing 100mg seaweed extract~     or a matched placebo daily for an 8 week period, with an 8 week washout period between each~     treatment. Fasting blood and urine samples will be taken from each volunteer at 4~     time-points during the study, at baseline and completion of the 2 treatment phases.~   "
58161|NCT02295865|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     JNJ-38518168 in participants with moderate to severe plaque-type psoriasis (common~     genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches).~   "
58162|NCT02295852|"~     Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are~     several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study~     is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from~     vegetables instead of dairy products, on blood pressure, body weight a main parameters of~     the glucose and lipid metabolisms.~      This study is a randomized, parallel group trial that will be performed in the Outpatient~     Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC>~     28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be~     prescribed to all patients, they will be divided in two groups. The first will change the~     diet to that similar for total calories, percent composition of macronutrients and salt but~     enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the~     first diet. The observation period will be of 1 year with anthropometric (body weight and~     height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic~     (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium~     and potassium) controls after 3-6 and 12 months.~   "
58163|NCT02295839|"~     This pilot randomized controlled trial examined the feasibility, acceptability and~     effectiveness of an intervention to improve sleep quality and decrease fatigue levels in~     children with a diagnosis of ALL, during maintenance treatment. Families were randomized to~     usual care or the intervention. The intervention included a sleep hygiene and relaxation~     education session with a nurse practitioner, literature for home, two story books, and a~     follow-up phone call. Self-reported measures were used in addition to actigraphy to measure~     children's quality and quantity of sleep.~   "
58164|NCT02295826|"~     Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess~     hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown~     to be associated with much lower intracranial hemorrhage rates. It has been suggested that~     this agent may provide the superior benefits of anticoagulation in acute stroke, without the~     concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.~      Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants~     (n=300) with TIA or ischemic stroke (NIHSS score <9) will be enrolled within 48 hours of~     symptom onset from approximately four (4) health care centres across Canada. All~     participants will have an MRI with DWI lesion volume < 25 ml. Participants will be~     randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard~     of care). All stroke patients will initially be screened with a non-contrast CT scan of the~     brain. The first MRI will be performed within 48 hours of symptom onset. Imaging studies~     will be repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.~      Study Aims:~        1. Establish the safety of early anticoagulation with the novel oral anticoagulant~          dabigatran in acute cerebrovascular syndrome patients.~        2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT)~          associated with these treatments.~        3. Identify predictors of HT associated with acute dabigatran treatment.~      Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA~     treated patients will not be significantly different.~      Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation~     (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with~     substantial space- occupying effect, associated with clinical worsening (≥4 point increase~     in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment~     initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI~     sequence.~   "
58165|NCT02295813|"~     The purpose of this study is to assess the clinical and laboratory safety and to determine~     the pharmacokinetic profile of FBF001.~   "
58166|NCT02295800|"~     The study design includes an observational prospective cohort of HIV-positive~     pregnant/postpartum women and their infants enrolled during antenatal clinics (or~     immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and~     followed until the infants reach the age of 18 - 24 months and semi-structure interviews~     with a sub-set of these women. A second study component involves semi-structured interviews~     with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at~     the selected study facilities.~   "
58167|NCT02295787|"~     The investigators of this study plan to investigate the feasibility and efficacy of repeated~     doses of intranasal ketamine in severely depressed patients who are at least 65 years of age~     and experiencing suicidal ideation. The results of the study could lead to development of~     new strategies for treating depression.~   "
58168|NCT02295774|"~     Single Centre, open label assignment phase II clinical study.~      To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to~     endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma~     H2AX analysis, compared to control biopsies.~   "
58206|NCT02295280|"~     To determine if the intravenous administration of Metoclopramide and diphenhydramine in~     combination can effectively treat headaches in pregnant patients in those refractory to~     acetaminophen when compared to codeine~   "
64259|NCT02216214|"~     The purpose of this study is to assess the efficacy, safety and tolerability of mirabegron~     versus placebo in the treatment of older adult subjects with OAB.~   "
58169|NCT02295761|"~     Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered~     lifestyle counseling intervention on overweight and obese adolescent's physical activity,~     BMI and adherence to healthy lifestyles.~      Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.~      Settings: One of the Northern Finland healthcare districts school health care units.~      Participants: all overweight or obese 13-16 years old adolescent and their parents were~     invited to study.~      Methods: Adolescents were stratified by gender, age, and self-reported physical activity and~     they were randomized into three groups. Two experimental groups, where those both got~     Facebook-delivered lifestyle counseling and one of the experimental groups got activity~     monitor which showed the daily activity. One group served as a control group. Parents were~     allocated to intervention groups according which group their adolescent were randomized.~      Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline~     measurements have been done and assessment to adherence to healthy lifestyles have been~     measured. Follow-up measures have been conducted three months after baseline. Adherence to~     healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.~   "
58170|NCT02295748|"~     This is an open label, long-term extension study in approximately 24 male DMD subjects~     consisting of children (ages 4-12, inclusive) and adolescents (ages 13-16, inclusive) who~     participated in the MP-104-CL-005 PK study.~   "
58171|NCT02295735|"~     The aim of this randomized controlled trial is to test the efficacy of preventive dressings~     for pressure ulcer prevention.~   "
58172|NCT02295722|"~     Objective of study: To evaluate the safety and efficacy of infusional gemcitabine prior to~     HDM (high-dose melphalan) as HDCT (High Dose Chemotherapy) followed by autologous stem cell~     transplantation in patients with relapsed/refractory lymphoma.~   "
58173|NCT02295709|"~     Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical~     radicular pain resistant to conservation therapy, by which steroids can be delivered into~     anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the~     upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of~     fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel~     or not, many serious neurological complications caused by inadvertent intra-arterial~     injection have been reported2. Here, the investigators will introduce a novel cervical TFESI~     guided by ultrasound, which incidence of inadvertent vessel injury or injection might be~     lower than those guided by fluoroscopy.~   "
58174|NCT02295696|"~     EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on~     dialogue tools for adults with poorly regulated Type 2 diabetes.~   "
58175|NCT02295683|"~     The purpose of this study is to document safety and efficacy of renal sympathetic~     denervation treatment in subjects with uncontrolled hypertension by using Iberis renal~     denervation system.~   "
58176|NCT02295670|"~     Endotracheal intubation (ETI) is perceived as the optimal method of providing and~     maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC)~     guidelines emphasized the importance of minimal interruption during cardiopulmonary~     resuscitation (CPR). These guidelines also suggest that skilled operators should be able to~     secure the airway without interrupting chest compression. The aim of the study was to~     compare time and success rates of the Vividtrac video-laryngoscope and the Miller~     laryngoscope for emergency intubation during simulated pediatric CPR.~   "
58177|NCT02295657|"~     The aim of this study was to compare time, success rates of different double-lumen tubes in~     intubation in a standardized manikin model.~   "
58178|NCT02295644|"~     Introduction. Temporomandibular disorders (TMD) are a group of conditions that are~     multifactorial in nature, and it primarily presents with symptoms of pain and decreased~     functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown~     clinically to provide immediate relief of pain in patients with different musculoskeletal~     disorders. In this study, for the purpose of immediate management of painful masticatory~     muscle and tissues, the investigators attempt to understand the mechanism of therapeutic~     ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the~     investigators aim to determine if there is a dose response relationship between two~     different intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and~     100%). A third purpose is to determine if therapeutic ultrasound applied to the masseter~     muscle is capable of eliciting segmental effects in the temporalis muscle. Methods. A total~     of 28 adult females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD)~     will be recruited for this investigational trial. Each subject will be randomly allocated to~     one of the four ultrasound intervention groups each of which has different settings. Using~     Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for~     five minutes on each side of the face. A template will be used to confine the borders of the~     muscle and to determine the sites for the repeated outcome measures. Outcome parameters of:~     self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and~     intraoral muscle temperatures will be measured for masseter and temporalis muscles on each~     side of the face, and will be assessed at baseline and after intervention on each side.~   "
58179|NCT02295631|"~     The aim of this study was to compare time, success rates of different tracheal tubes~     (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in~     a standardized manikin model.~   "
58180|NCT02295618|"~     The objective of this study is to compared effectiveness of intubation using ETView~     VivaSight SL and standard tracheal tube during resuscitation performed by a~     novice-physicians.~   "
58181|NCT02295605|"~     Forty six patients with knee osteoarthritis will be randomly allocated into two groups:~     water-based exercises and land-based exercises. Both of them will receive a strengthening~     exercise protocol for lower limb muscles. A blind investigator will assess the patients~     before and immediately after, 3 months and 6 months following the interventions. The main~     outcomes will be pain, function and strength.~   "
58182|NCT02295592|"~     TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized~     controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids~     recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.~   "
62232|NCT02242682|"~     The purpose of this study is to determine if video education is an effective means of~     caregiver education in the waiting room of a pediatric emergency department (ED). This will~     be tested with the showing of a child passenger safety video.~   "
58184|NCT02295566|"~     The lungs of most patients with cystic fibrosis (CF) become chronically infected with~     bacteria called Pseudomonas aeruginosa during childhood. This infection is now known to~     consist of free-living bacteria (known as planktonic bacteria) and bacteria in colonies on~     body surfaces known as biofilms. The bacteria in biofilms are more resistant and tolerant~     to antibiotics. Current CF treatment of exacerbations aims to eradicate or control~     pseudomonal infection using aggressive antibiotic regimes.~      Despite this treatment many patients develop chronic infection which is never cleared.~     Chronic infection causes damage to the lungs. Patients colonised with Pseudomonas are more~     unwell and die at a younger age. Our laboratory has established that low dose nitric oxide~     (NO) can disrupt pseudomonal biofilms in the laboratory. This pilot study will discover~     whether non-toxic levels of NO administered to participants during an episode of acute~     infection (exacerbation) will disrupt bacteria from biofilms and increase the effectiveness~     of antibiotic therapy. This protocol describes a participant-blind randomised controlled~     pilot study of treatment with nitric oxide gas during an acute infective exacerbation (also~     known simply as an acute exacerbation). Patients with CF aged 12 or above will be asked to~     take part.~      They will be randomised to receive 7 days either of inhaled nitric oxide gas or placebo~     alongside standard therapy during an exacerbation. Sputum samples will be obtained before,~     during and after the treatment period for microbiological analysis. The primary endpoint~     will be the microbiological effect on bacterial biofilms before and after NO adjunctive~     therapy. Secondary microbiological endpoints will include the between group differences in~     pseudomonal colony forming units (CFU‟s), biofilm NO levels and detailed characterisation of~     biofilms before and after treatment.~      Secondary clinical endpoints will include lung function and well-established indicators~     quality of life. The aim of this randomised pilot study is as proof of concept and to guide~     the design of a large multi-centre trial to definitively evaluate the effectiveness of NO or~     NO donors as adjunctive therapy in CF.~   "
58185|NCT02295553|"~     The purpose of this study is to examine the dose-response relationship of ketamine in~     combination with propofol.~   "
58186|NCT02295540|"~     This phase I/II trial studies how well hypofractionated radiation therapy followed by~     surgery works in treating patients with squamous cell carcinoma of the oral cavity that has~     spread to other places in the body. Hypofractionated radiation therapy delivers higher doses~     of radiation therapy over a shorter period of time and may kill more tumor cells and have~     fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the~     tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may~     be a better treatment for squamous cell carcinoma of the oral cavity.~   "
58187|NCT02295527|"~     Hip fractures resulting from falls increase substantially with advancing age and less than a~     half of the elderly that have sustained and survived after the surgery regain their former~     levels of mobility. There is increasing evidence that rehabilitation interventions involving~     exercises and extended beyond the sub acute phase or even in a later stage of care have a~     positive impact on various functional abilities. The purpose of this study is to determine~     if an exercise program training for people who have suffered a fall-related hip fracture~     will improve functional mobility when compared with usual care. Randomized controlled trial~     using blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60~     years or over who have suffered a hip fracture due to a fall and have or have not completed~     physiotherapy and/or rehabilitation. These participants will be in a later stage~     rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to~     the Intervention Group (IG) will be submitted to a physical exercise program involving a~     progressive and challenging balance training and a neuromuscular and functional training of~     the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour,~     in the first, second and third month after randomization and will be oriented to perform~     exercises, twice a week, through a booklet. Visits to follow up exercises progression will~     be conducted once a month, from de fourth to the sixth month and each two months until the~     end of the follow up at the 12th month, summing up 18 sessions. Participants will receive~     monthly phone calls to increase exercise adherence. The control group will receive usual~     care. The primary outcome will be mobility-related disability and participants will be~     assessed in the baseline, at the end of the intervention (3 months), at 6 and 12 months. The~     participants will receive monthly phone calls to investigate falls and exercise adherence.~     Adverse effects will be monitored.~   "
58188|NCT02295514|"~     Despite major advances in the treatment and understanding of the pathophysiological~     mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a~     prevalence > 20% in intensive care units, it is now in a population increasingly aging with~     many co-morbidities, a real public health problem. Thus, changes in treatment to~     physiological axes could change the prognosis of these patients. Protein Tyrosine~     Phosphatase 1B (PTP1B) is involved in the negative regulation of many cellular pathways such~     as the response to insulin, leptin and certain growth factors and endothelial nitric oxide~     production. PTP1B appears to be particularly involved in the control of endothelial function~     and insulin secretion. Under these conditions, encouraging results have been obtained in a~     model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by~     inhibition of PTP1B on models of heart failure. Recent advances have broadened the~     pathophysiological implications of PTP1B conferring a potential role in the regulation of~     inflammatory processes. In an experimental model of septic shock (Inserm 1096), the~     investigators demonstrated a significant improvement in survival and cardiovascular function~     in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the~     downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock~     induces many changes in carbohydrate metabolism. These changes result in hyperglycemia~     associated with insulin resistance, an independent risk factor of morbidity and mortality.~     Taken together, these data suggest that the expression of PTP1B could be useful in septic~     patients by modulating insulin resistance and thus the prognosis of these patients. This~     justifies the investigator clinical research project on the relationship between the~     expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in~     patients with septic shock with multiple organ failure.~   "
58189|NCT02295501|"~     The objective of this Phase 1 safety study is to provide access to the potential therapeutic~     benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to~     plasma from donors who may be infected with other transfusion-transmitted pathogens, not~     detectable by current licensed donor testing procedures, will be mitigated by using pathogen~     inactivation to minimize the risk of the TTI from these donors, who would otherwise be~     deferred and ineligible for blood donation.~   "
58190|NCT02295488|"~     Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a~     very rapid increase in doses of venom extracts administered during the SIT in a day without~     systemic reaction of the patient which is not yet explained. The hypothesis is that this~     good tolerance is due to a rapid decrease in the response of mast cells and basophils to the~     allergen..~      The main objective is to study basophil activation in response to the allergen during the~     first day of desensitization, measured by basophil activation test.~      The initiation of desensitization follow a protocol of rapid growth rates. The basophil~     activation level in the course of desensitization will be analyzed by flow cytometry after~     in vitro stimulation by allergen.~      Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the~     expression of different proteins in blood basophils will be studied by measuring their~     messenger RNAs~   "
58191|NCT02295475|"~     ASTRO-APS is a prospective, randomized, open-label blinded endpoint pilot study among~     patients with a clinical diagnosis of the AntiPhospholipid Syndrome and are already taking~     an anticoagulant for the secondary prevention of thrombosis (blood clots). Subjects will be~     randomized to receive either warfarin (target INR range 2-3) or apixaban 5 mg twice daily.~     Patients will follow up with the study team for 13 months. 2 in-clinic follow-up visits will~     be performed as well as 4 telephone follow-up visits. Study participants will be asked to~     consent to follow up telephone calls and questionnaires at 3 month intervals following the~     completion of the study procedures for the main portion of the study.~   "
62257|NCT02242357|"~     Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual~     daily-practice prescribing conditions in hypertensive patients~   "
58192|NCT02295462|"~     Background: Up to 90% of nursing home residents with dementia experience behavioural and~     psychological symptoms like apathy, agitation, and anxiety. According to analyses of~     prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line~     treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed~     for inappropriate reasons and too long without regular review. The use of antipsychotics is~     associated with adverse events like increased risk of falling, stroke, and mortality. This~     study aims to investigate whether a person-centered care approach developed in the United~     Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators~     trial is to achieve a clinically relevant reduction of the proportion of residents with alt~     least one antipsychotic drug prescription.~      Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day~     initial skill training on person-centred care and on-going training and support programme)~     with a control group receiving optimised usual care. Both study groups will receive a~     medication review by an experienced psychiatrist with feedback to the prescribing physician.~     Overall, 36 nursing homes from East, North and West Germany will be included and randomised.~     The primary outcome is defined as the proportion of residents receiving at least one~     antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life,~     behavioural and psychological symptoms of dementia as well as safety parameters like falls~     and fall-related medical attention. Cost parameters will be collected and process evaluation~     will be performed alongside the trial.~   "
58193|NCT02295449|"~     Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing~     prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound~     (CEUS) using SonoVue® as contrast agent.~      The software analyses the ascending phase of enhancement (wash-in) and calculates the mode~     and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis~     of cancer is based on the combination of these two parameters.~      The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate~     software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound~     (CEUS).~      The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time~     to peak, the transit time and the area under the enhancement curve (parameters not used by~     the VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign~     peripheral zone at contrast-enhanced ultrasound (CEUS).~      The study will enroll patients referred for prostate biopsy. The US transrectal probe will~     be inserted and the local anesthesia performed as per the institution's standard of care~     protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer~     (e.g. based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue®~     will then be injected and the ultrasound enhancement of this plane will be recorded during 2~     minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the~     recording is still on, so that it will be possible to calculate quantitative enhancement~     parameters at the exact location of the biopsy.~      Then, the operator will choose a plane that is likely not to contain cancer in the opposite~     prostate lobe and the same process will be repeated with injection of the second half of the~     vial.~      The rest of the biopsies will be performed as per the institution's standard of care~     protocol.~      The two recordings will be sent to Bracco's Research center in Geneva in order to:~        -  Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software~          results~        -  Calculate the wash-out rate, the time to peak, the transit time and the area under the~          enhancement curve at the biopsy location.~      The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy~     samples) will be processed and analysed at the institution's department of Pathology and~     their results will be blinded to the Bracco's Research center.~      The correlation between the biopsy results, the VueBoxTM-Prostate software results and the~     wash-out rate, time to peak, transit time and area under the enhancement curve will be~     performed by the study investigator.~      In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of~     an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).~   "
58194|NCT02295436|"~     The primary objective of the the study was to evaluate the pharmacokinetic properties of~     minodronic acid tablets following single and multiple oral administration in healthy Chinese~     subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was~     also explored.~   "
58195|NCT02295423|"~     The investigators hope to survey anesthesiologists who have participated in a non-CME~     regional anesthesia workshop at VAPAHCS over the past 4 years on the number and types of~     nerve block procedures that they performed, nerve localization method (e.g., ultrasound,~     electrical stimulation, or both), and whether the nerve blocks performed were~     single-injection or catheter-based.~   "
58196|NCT02295410|"~     The intent of this study is to assess whether cognitive functioning improves as~     Post-Traumatic Stress Disorder (PTSD) symptoms decrease as a step toward developing an~     objective measure of PTSD improvement. The study also evaluates the feasibility and~     effectiveness of home-based telemental health care (HBTMH) compared to usual care in the~     treatment of rural Veterans with posttraumatic stress disorder (PTSD). For this~     assessment-only study, the investigators plan to assess approximately 200 Veterans in total,~     of which 150 will be undergoing regular evidenced-based therapy (EBT) for PTSD, and 50 will~     be receiving other treatment as usual (TAU). The 150 veterans in the EBT group will be~     undergoing Cognitive Processing Therapy (CPT), Cognitive-Behavioral Couple Therapy (CBCT),~     Prolonged Exposure (PE), or Seeking Safety (SS) treatment for PTSD in clinic or via~     home-based telemental health (HBTMH). The study will also assess a comparison group of~     approximately 50 rural Veterans with PTSD diagnoses who are receiving treatment as usual~     (TAU) (neither EBT nor HBTMH). The HBTMH patients will be recruited from an Office of Rural~     Health (ORH) funded project to VA Pacific Island Health Care System (VAPIHCS), based at the~     National Center for PTSD (NCPTSD) and funded to offer 100 rural Veterans mental health~     treatment in their homes. This research protocol intends to assess rural veterans with PTSD~     who are being seen within this clinic versus those who have been referred for HBTMH yet who~     are ineligible for pragmatic purposes, with outcomes including feasibility,~     cost-effectiveness, and clinical effectiveness. The cognitive change will also be measured~     in patients with PTSD diagnoses receiving EBT PTSD treatment at VA clinics in the Pacific~     Islands.~   "
58197|NCT02295397|"~     Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food~     provocation with a dose of the allergenic food to which 5% of the respective food allergic~     population (ED05) has been calculated to respond with allergic reactions (single shot~     study).~      In patients with a hazelnut or peanut allergy a double-blind placebo controlled food~     challenge with cookies containing either placebo or hazelnut and peanut respectively will be~     performed to determine threshold levels eliciting an allergic reaction. The results for~     threshold levels determined by cookie matrix will be compared to the results gained from the~     EuroPrevall project (matrix comparison study).~      In patients with a walnut allergy double-blind placebo controlled provocation with walnut~     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess~     the impact of PPI on the threshold level and on the clinical manifestation.~   "
58207|NCT02295267|"~     Accurate diagnosis of food allergy depends on the identification of the causative allergenic~     molecule(s). The proposed study intends to investigate and compare the pattern of IgE~     antibody sensitisation in walnut allergic subjects from three different regions of Europe~     (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of~     novel allergen reagents.~   "
58259|NCT02294591|"~     This trial investigate add-on treatment with 3 g NAC vs. placebo in 20 weeks in patients~     suffering from bipolar depression. The primary outcome is MADRS-score, and the secondary~     outcomes are other psychometric evaluations oxidative stress biomarkers in urine.~   "
58198|NCT02295384|"~     For the majority of patients, management of HIV-1 infection involves effective and well~     tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the~     availability of single tablet regimens (STRs) with single tablet once daily dosing. STR~     therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013;~     Sax et al., 2012).~      However, the aging of the HIV cohort in Australia and globally has raised issues of~     increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson,~     2012; Edelman et al., 2013).~      Polypharmacy may not only impact on adherence, but also increases the potential for~     drug-drug interactions (Holtzman et al., 2013).~      Stribild, a highly effective STR, contains cobicistat to boost the levels of the component~     integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but~     acts by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized~     via this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014).~     Additionally there is evidence of increased risk of nephrotoxicity with co-administration of~     tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).~      Data on use of concomitant medications in Australian patients with HIV is sparse. This study~     aims to determine, in a large caseload community HIV practice, the use of concomitant~     medications in HIV, patient pill load and dosing frequency, and potential drug-drug~     interactions with stribild.~   "
58199|NCT02295371|"~     Prospective reporting of safety incidents concerning drug treatment by approximately 120~     primary care physicians or pediatricians during 2015.~   "
58200|NCT02295358|"~     This study is designed with the intention to further elucidate the effects of omega-3 fatty~     acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown~     statistically significant lowering of IOP with use of omega-3 fatty acids but have only been~     performed in animal models. This study will be the first to attempt replication in human~     models. A limited number of studies have shown an increase in tear production/volume as well~     as a decrease in the subjective symptoms of dry eye, but more studies are needed to better~     define these effects. Better understanding of the effects of this supplement on intraocular~     pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of~     glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies~     about new potential treatment options for these conditions.~   "
58201|NCT02295345|"~     Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be~     effective in a variety of populations including postpartum women, as well as the~     demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have~     investigated its efficacy during pregnancy. This project will investigate the efficacy and~     acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.~   "
58202|NCT02295332|"~     This is a single center, randomized, double-blind, placebo-controlled, single ascending dose~     study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic~     effects of single doses of RG7625 in healthy male and female volunteers.~      The study will employ an interleaved cohort ('leapfrog') design in which dosing is~     alternated between two cohorts and each individual within a cohort will receive study drug~     dosing on four occasions - in effect giving a four treatment, four period, four-way~     crossover for each individual. The minimum duration for each participant is approximately 8~     weeks.~   "
58203|NCT02295319|"~     The present non-blinded randomized controlled trial (RCT) investigates the effect of a~     comprehensive discharge model in adult medical patients discharged directly home from an~     Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one~     hospital admission 12 months prior to index hospitalization and be discharged for further~     follow-up by general practitioner, home care nursing or in an out-patient clinic. The model~     consists of 3 main steps during the short term stay in the AAU. First, patients are screened~     for pre-hospital conditions that might have contributed to the index hospitalization i.e.~     functional ability, ongoing treatment including drug treatment, need for additional~     assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses,~     walker. Second, at point of discharge there will be a thorough assessment of the discharge~     plan focusing on the patients' comprehension of the discharge plan as well as accept of the~     suggested treatment and follow-up. Third, within 2 days after discharge the patient will~     receive a discharge letter by email or postal mail written in plain language and repeating~     the information provided in the discharge summary to the general practitioner. Subsequently,~     the patient will receive a telephone follow-up from the research nurse addressing the~     content in the discharge letter and possible unresolved issues related to the index~     hospitalization. Patients in the control group receives the usual discharge practice in the~     AAU which does not include a discharge letter to the patient and telephone follow-up after~     discharge.~      The primary endpoint is number of readmissions within 72 hours and 30 days after discharge.~     Secondary endpoints are healthcare service utilization within 30 days after discharge this~     includes number of contacts to general practitioner, out-of-hours physicians, emergency~     departments and if possible visits by home care nurses. Additionally, Quality-of-Life~     measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the~     discharge process is measured 7 days after discharge by a Danish national patient experience~     survey - serves as secondary endpoints.~   "
58204|NCT02295306|"~     Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease~     affecting 8-12% of the general population and often more than 70% of the bariatric surgical~     population. OSA is characterized by the repetitive collapse of the upper airway, causing a~     reduction or cessation in airflow and decreases in oxygen saturation. These events are~     resolved by arousals from sleep, reducing sleep quality and leading to excessive daytime~     sleepiness. An in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of~     OSA.~      Previous studies have established obstructive sleep apnea (OSA) as a potential independent~     risk factor for postoperative complications, adverse surgical outcomes, and longer hospital~     stays.~      Patients with OSA have an increase in postoperative complications, the most frequent being~     oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the~     clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk~     for OSA. It has been suggested that OSA events may be even more frequent post operatively~     because of the residual effects of anesthesia and the use of potent pain medications such as~     opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental~     O2 may mask any desaturations and there is no convenient technology to noninvasively monitor~     ventilation to detect apnea and hypopnea in post-surgical patients.~      New advances in technology and digital signal processing have led to the development of an~     impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion,~     Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive~     measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our~     main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately~     reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.~   "
58205|NCT02295293|"~     Coronary heart disease and stroke are two main causes of human deaths and is directly~     related to increased levels of plasma lipids.High total cholesterol and low high density~     lipoprotein cholesterol concentrations are often associated with endothelium dysfunction and~     inflammation, which can be followed by atherosclerosis.~      Rhus coriaria L. (Rhus) with the public name of Somagh is a plant species in the~     anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran,~     Turkey and Arabic countries).~      In a double blind randomized placebo-controlled clinical trial, the investigators want to~     evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with~     hyperlipidemia.~   "
58208|NCT02295254|"~     The human gut contain a wide range of microorganisms creating the gut microbiome. The~     microbiome has great impact on metabolic and immunologic processes and responses. Travelers~     who travel to tropical destinations where the intestinal infection risk is high are prone to~     microbiome changes. During the current study the travelers will give feces specimen before~     and after the travel and their microbiome will be analyzed.~   "
58209|NCT02295241|"~     The primary aim of this study is to compare traditional muscle function tests with~     computerized versions using body-worn motion sensors and video motion analysis of the same~     tests. The investigators selected the Timed Up and Go (TUG) test as the investigators~     primary variable for this aim with several other function tests (e.g., repeated chair rise,~     6-meter walk, 2-minute walk, Romberg stance, semi-tandem / tandem stance) as secondary~     variables. The investigators primary hypothesis is that the computerized versions of the TUG~     test are highly correlated (>0.9) with the traditional method, but with comparable or better~     reproducibility. Secondary analyses will correlate other function tests with their~     computerized version, again with the hypothesis that they are highly correlated and that~     computerized versions are of similar or better reproducibility. This analysis will also~     compare traditional assessments of balance with a computerized balance method, computerized~     dynamic posturography.~   "
58210|NCT02295228|"~     It is essential that serum 25(OH)D changes following surgery be clarified, and the~     mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis~     of this study is that elective total hip arthroplasty reduces serum total 25(OH)D.~   "
58211|NCT02295215|"~     The prevalence of Chagas' disease continues high even in the developed countries. Chagasic~     Cardiomyopathy with preserved ventricular function is an understudied form of Chagas~     disease. Since a majority of patients with these changes progress to dilated form with~     ventricular dysfunction with all its serious consequences, it is interesting to better~     understand the pathophysiology of the disease at the stage where there electrocardiographic~     changes and preserved ventricular function. And besides, search strategies to slow the~     progress, or even prevent the chronic phase of the disease. For this reason the~     investigators will evaluate the effects of exercise training in patients with Chagas~     cardiomyopathy without ventricular dysfunction.~   "
58212|NCT02295202|"~     Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and~     metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or~     contributes to increase the morbidity associated with metabolic syndrome. This study was~     designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with~     metabolic syndrome.~   "
58213|NCT02295189|"~     Osteoarthritis is a disabling disease of the joint spaces and has a high impact on society~     due to the amount of people who are affected by the disease. Nonoperative management is a~     mainstay of therapy in most patients. Ketorolac tromethamine and triamcinolone acetonide~     intra-articular knee injections will be compared in a prospective, double-blinded,~     randomized trial in subjects with knee osteoarthritis. Subjects will be enrolled from the~     Orthopaedics Clinic based on inclusion and exclusion criteria. Intra-articular knee~     injection of ketorolac tromethamine or triamcinolone acetonide will be performed under~     ultrasound guidance. Multiple outcome measures will be performed throughout the six month~     period of follow-up. The investigators predict ketorolac tromethamine will have a longer~     duration of pain relief when compared to triamcinolone acetonide. The investigators predict~     there will be no differences between the two intra-articular knee injections in terms of~     function using validated scoring instruments.~   "
58214|NCT02295176|"~     Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in~     patients with MetS and increased LV mass.~      168 patients will be enrolled in this randomized, double-blind, parallel-group,~     placebo-controlled trial and treated for 24 weeks.~   "
58215|NCT02295163|"~     Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of~     locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the~     main side-effects of ADT. There are no successful and well-tolerable treatment options~     available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a~     means of interrupting parts of the sympathetic nervous system involved in temperature~     regulation.~      Objective of this study:~      To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus~     sham procedure~   "
58216|NCT02295150|"~     This study is a prospective evaluation of the relationship between lean body weight and~     anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous~     administration in morbidly obese patients after bariatric surgery.~   "
58217|NCT02295137|"~     Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm~     ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a~     minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular~     techniques are used to treat patients with more complex pathology by using custom-made~     devices and additional stents. In order to accomplish the technical success on advanced~     EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray~     fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the~     target arteries (arteriograms) are required. Subsequently patients are exposed to higher~     dose of contrast and radiation, compared to conventional EVAR. This study is to assess the~     feasibility of proper visceral and renal arteries catheterization using a 3D model obtained~     from pre-procedural computed tomographic angiography (CTA), fused with real-time~     fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the~     contrast use and patient radiation exposure while achieving procedure success during~     Advanced EVAR.~   "
58218|NCT02295124|"~     The study aims to compare the incidence of side effects caused by Oxycodone and~     Hydromorphone.~   "
58245|NCT02294773|"~     The aim of this study is to assess the impact of the timing of intrauterine insemination~     (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home~     ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place~     at the offices of Midwest Fertility Specialists and include patients who have been~     independently recommended by their primary physician to undergo ovulation induction with~     clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.~   "
64321|NCT02215408|"~     The study will test whether a pharmacist-run cardiovascular risk service (CVRS) at the~     University of Iowa can increase use of national standards of care in clinics~   "
58219|NCT02295111|"~     Chronic pelvic pain (CPP) is a debilitating condition that affects over 1 million women in~     the United Kingdom. The annual healthcare costs are estimated at over £150 million. Proven~     interventions which include the use of analgesics or hormonal treatments are unsatisfactory~     in many cases.~      The investigators believe that the meridian balance method (BM) electro-acupuncture (EA)~     treatment (which includes a Traditional Chinese Medicine Health Consultation [TCM HC]) may~     be helpful in the management of CPP. Studies on the mechanisms of EA have demonstrated an~     analgesic effect. A recent individual patient data meta-analysis on the use of acupuncture~     for four chronic pain conditions found a small statistically significant effect size when~     compared to sham acupuncture. The effect size was larger and statistically significant when~     compared to usual care controls. This meta-analysis, and other large studies, suggests that,~     in addition to this analgesic effect, the interaction between the patient and the healthcare~     provider also plays a role in its effect on painful symptoms.~      Our hypothesis is that the meridian BMEA treatment alleviates pain, and improves physical~     and emotional functioning, in women with CPP.~      The investigators plan to undertake a single centre pilot study to assess the feasibility of~     performing a future three-armed randomised controlled, parallel group design trial to~     determine the efficacy of the meridian balance method electro-acupuncture (BMEA) treatment~     in the management of women with CPP.~      The primary objective is to determine whether it is possible to achieve acceptable~     recruitment and retention rates within defined inclusion/exclusion criteria.~      The secondary objectives are to determine the effectiveness and acceptability to patients of~     the proposed methods of recruitment, randomisation, interventions and assessment tools.~      The investigators aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and~     randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention~     will be monitored by validated pain, physical and emotional functioning questionnaires at~     weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on~     study experience will be conducted at the completion of the study.~   "
58220|NCT02295098|"~     The investigators plan to compare the incidence of successful placement of epidural pain~     catheters versus paracostal catheters for the control of pain and prevention of pulmonary~     complications for adult trauma patients with blunt chest wall trauma resulting in multiple~     rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is~     being admitted to the Surgical ICU, and is encountered within 72 hours from the time of~     their injury, they will be eligible for the study. If they (or a proxy) choose to~     participate, consent will be obtained and they will randomly be assigned to receive either~     an epidural or paracostal catheter for pain control. The aim of the study is to determine if~     paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma~     patients. Secondarily the investigators will evaluate success and time of placement of the~     assigned intervention and follow the patient throughout their hospital course to compare the~     success of analgesia provided by each modality along with any complications and/or benefits~     of the two types of catheters.~   "
58221|NCT02295085|"~     The Fernald Community Cohort consists of the 9782 persons who were enrolled in the Fernald~     Medical Monitoring Program (FMMP) (1990-2008). The initial comprehensive examination~     conducted as part of the Fernald Medical Monitoring Program (FMMP) began in the autumn of~     1990. The FMMP provided 9,782 initial examinations and 42,775 re-examinations. An extensive~     computerized database and biospecimen repository was created to provide research resources~     for future studies. All questionnaire, examination and diagnostic procedure data collected~     from the FMMP were [coded by certified medical record coders,] double entered with~     verification into a SAS database on site of the examinations. Cryo-preserved blood and urine~     samples were collected at enrollment and at various intervals throughout follow-up. At the~     first examination three 1-ml aliquots of whole blood, plasma, serum, urine and urine with~     buffer were obtained from each participant (15 aliquots per person) for future analyses.~     Additional whole blood and serum was obtained in 1996-1997 and 2006-2008. Specimens have~     been stored in -80 degree freezers; over 160,000 biospecimens are in the archive. Since~     1994, the FCC has had an established procedure for sharing data and biospecimens with~     qualified researchers. Both the policy and application forms can be found at~     www.eh.uc.edu/fmmp/research.~   "
58222|NCT02295072|"~     The ActiveBrains project aims to examine whether a 5-months physical exercise program has~     benefits on cognition and brain, as well as on selected physical and mental health outcomes~     in preadolescent overweight/obese children.~   "
58223|NCT02295059|"~     The investigators study aims to determine biological changes associated with a low vs high~     dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over~     12 months in women at risk for recurrent breast cancer. The objectives of the trial are to~     develop mammary epithelial, adipose tissue specific markers of exposure and response to~     omega 3 fatty acid supplements that can be carried forward into definitive intervention~     trials of omega 3 fatty acids for breast cancer prevention. The investigators will randomize~     80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative~     breast cancer to either a high or low dose of omega 3 fatty acids. Using fine needle~     aspiration to procure cellular samples of breast epithelial and adipose tissue, the~     investigators will determine the effects of omega 3 fatty acids on mammary specific~     biomarkers of response.~   "
58224|NCT02295046|"~     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium~     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine~     besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals~     Dublin, Ireland in Healthy Male and Female Volunteers under Fasting conditions.~   "
58225|NCT02295033|"~     Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase~     III trial is studying the effect of an extra dose of radiation therapy (Boost dose) after~     breast conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it~     works compared to no further therapy in treating women with early breast cancer that has~     been surgically removed.~   "
58226|NCT02295020|"~     The objectives of the study are 1.) to evaluate pain relief following the application of the~     Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more~     effective at reducing inflammation than standard of care alone using synovial fluid cytokine~     analysis and validated outcome measures.~   "
58246|NCT02294760|"~     A recent randomised, controlled, crossover study has shown that sacral nerve stimulation~     (SNS) significantly reduces symptoms and improves quality of life of highly selected~     patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is~     associated with consistent changes in rectal sensitivity and biomechanical wall properties.~      The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation~     on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled,~     crossover study.~   "
58408|NCT02292654|"~     Primary Objective:~      To evaluate the safety and tolerability of olipudase alfa administered intravenously in~     pediatric patients every 2 weeks for 52 weeks.~      Secondary Objective:~      To characterize the pharmacokinetic profile and evaluate the pharmacodynamics and~     exploratory efficacy of olipudase alfa administered intravenously in pediatric patients~     every 2 weeks for 52 weeks.~   "
58227|NCT02295007|"~     Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV)~     or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in~     this study if their parent has the ability to receive and send text messages. Children~     enrolled in this study will be observed daily for an eight-day period starting on the day of~     vaccine administration, and then continuing over the next 7 days, and then weekly for 42~     days. On the day of enrollment and nightly for the next seven days, the parent will report~     via text message what their child's highest temperature is. If fever is present, they will~     then be prompted for additional information including other symptoms, antipyretic use and~     medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination,~     parents will be asked via text message about breathing problems, specifically cough,~     wheezing and chest tightness. They will also be asked about medications taken and care~     sought. The purpose of this study is to assess the feasibility of collecting this data.~   "
58228|NCT02294994|"~     The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa~     inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which~     include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary~     thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause~     mortality. Secondary endpoints are incidence of major bleeding and the rate of site access~     complication.~   "
58229|NCT02294981|"~     The purpose of this study is to determine the best dosing strategy when using Excimer Laser~     to treat plaque-type psoriasis. In this study, half of the body's psoriasis will be treated~     with a new dosing strategy, and the other half will be treated with the conventional method.~     We hope to show that the new dosing strategy will result in faster improvement of psoriasis.~   "
58230|NCT02294968|"~     The aims of this study are to determine whether a group-based parent support program~     (Family Startup) can lead to early improved parental sense of competence, family~     relations, and child development. Evaluation is based on a randomized controlled trial, with~     half of the participants receiving Family Startup and the other half receiving treatment as~     usual.~   "
58231|NCT02294955|"~     The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of~     atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic~     atrial fibrillation.~      It is a randomized, prospective, controlled, open-label multicentre, parallel-group study~     including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms~     related to atrial fibrillation and who have failed or been intolerant to at least one~     anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during~     the previous 12 months and at least one symptomatic episode during the previous 2 months or~     at least 2 symptomatic episodes of persistent AF in the previous 12 months.~      Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for~     rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation,~     planned valve surgery within 2 years, contraindication to treatment with anticoagulants,~     heart failure, left atrial diameter > 60 mm, unstable angina or acute myocardial infarction~     within the last 3 months, cardiac revascularization procedure within the last 6 months,~     prior cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation~     procedure.~      The primary endpoint is general health-related quality of life at 12 months follow-up. The~     main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular~     hospitalization, symptoms, heart failure, left atrial and ventricular function and~     diameters, exercise capacity, health care economics, rhythm, atrial fibrillation burden,~     successful versus failed treatment, safety and cross-overs over time.~      Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the~     heart rhythm during a two month Run-in period, for the definition of the basic atrial~     fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for~     rhythm or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12,~     24, 36 and 48 months of follow-up, while health economy will be evaluated at 24 and 48~     months of follow-up.. In case of documented disease progression or unacceptable toxicity,~     subjects will be switched to the alternative regimen. The main statistical analysis of the~     primary endpoint will be based on the intention-to-treat population. The trial duration is~     48 months.~   "
58232|NCT02294942|"~     A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of~     add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina~     pectoris.~   "
58233|NCT02294929|"~     Prospective and explorative clinical study. The objective is to assess the clinical efficacy~     of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with~     longstanding persistent atrial fibrillation (AF) at one year follow up.~      44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF~     duration longer than one year, who have not previously undergone an AF ablation procedure,~     and have symptoms related to AF corresponding to at least European Heart Rhythm Association~     (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or~     class I or III antiarrhythmic drug.~      Excluded are those with congestive heart failure with New York Heart Association (NYHA)~     class 3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm,~     significant valvular disease or planned cardiac intervention within next 12 months, and~     conventional contraindications for AF ablation procedures.~      Patients will be screened with echocardiography and response to electrical cardioversion.~     Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm.~     Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon~     ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping~     catheter.~      All patients will be subject to electroanatomical voltage mapping during sinus rhythm for~     demonstration of extent of atrial myocardial lesions after ablation.~      Patients will be followed every third month up to one year after the ablation procedure.~     Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9~     and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA~     score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation~     procedure will be re-studied after 8-12 months while asymptomatic patients will be studied~     at 12 months follow up.~      Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary~     end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according~     to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse~     Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of~     freedom from AF, complications, hospitalization and Health economics.~   "
58234|NCT02294916|"~     The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller~     laryngoscope during pediatric resuscitation with and without chest compressions.~   "
58235|NCT02294903|"~     To assess the early histological outcomes of tissue ablation, adverse events and~     genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar~     device to treat localized prostate cancer in men with clinically significant prostate~     cancer.~   "
58236|NCT02294890|"~     At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients~     will be checked for signs of fibrosis diathesis. This will be done by examining their hands~     for Dupuytren's nodules and contractures and recording risk factors associated with~     increased severity and risk of recurrence of Dupuytren's contracture. These include family~     history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender,~     Ledderhose disease, first ray involvement, multiple ray involvement and ectopic~     fibromatosis.~      This way, two groups of patients will be identified: those with and those without signs of~     fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and~     6 months will be retrieved in the charts, the ROM at 12 months will be measured at that~     time. Also, additional procedures performed to increase ROM postoperatively will be~     retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia).~     Other causes for knee stiffness will have to be recorded, since these will be the most~     important exclusion criteria.~      In the patients with clear signs of finger contractures, any impression of increase of~     contracture over the past 12 months will be recorded.~   "
58237|NCT02294877|"~     The objectives of this program are: to characterize and describe the Mucopolysaccharidosis~     IV type A (MPS IVA) population as a whole, including the heterogeneity, progression, and~     natural history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®,~     including, but not limited to, the occurrence of serious hypersensitivity reactions,~     anaphylaxis, and changes in antibody status; to help the medical community with the~     development of recommendations for monitoring MPS IVA patients and reports on patient~     outcomes to optimize patient care; to collect data on other treatment paradigms, and~     evaluate the prevalences of their use and their effectiveness; to characterize the effects~     and safety of Vimizim treatment 5 years from enrollment in the Registry for patients under 5~     years of age; to monitor pregnancy exposure, including maternal, neonatal, and infant~     outcomes; and to monitor patients who have completed the MOR-005 and MOR-007 clinical~     trials. These patients will be encouraged to enroll in the applicable Registry Substudy and~     will be monitored using the MOR-005 and MOR-007 assessment schedules, respectively.~   "
58238|NCT02294864|"~     It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from~     pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in~     treatment of various etiologies of pain. However there are limited studies and research that~     prove its effectiveness in treating articular pain. The proposed study's primary aim is~     determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This~     study hypothesizes that PRF has analgesic properties immediately after treatment and at~     least 3 months afterwards compared to control treatment with physical therapy.~      Additionally this research project addresses several other objectives including:~        1. Provide a controlled study to determine the effectiveness of PRF for intra-articular~          pain~        2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain.~        3. Further scientific evidence on the overall effectiveness of PRF~        4. Provide evidence that PRF likely has other mechanism of action besides direct nerve~          stimulation of inhibitory pain pathways.~        5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee~          osteoarthritis.~   "
58239|NCT02294851|"~     This is a randomized, double-blind, placebo controlled, single ascending dose escalation,~     safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an~     intravenous infusion in healthy subjects.~   "
58240|NCT02294838|"~     The aim of this study is to determine the feasibility of demonstrating the following~     physiologically-descriptive quantities ('metrics'): the volume of plasma/volume of tissue~     (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space~     per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and~     post parotid stimulation in 10 healthy volunteers. Feasibility will be defined as 80% of~     volunteers achieving detectable signal changes in pre/post salivary MR images.~   "
58241|NCT02294825|"~     All women managed for endometriosis are included and followed up through the CIRENDO~     database.~      Information is obtained from surgical and histological records and from self-questionnaires~     completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER,~     FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient~     contact and follow-up are carried out by a clinical research technician. Postoperative~     follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and~     7 years.~   "
58242|NCT02294812|"~     In this study, the investigators are testing whether cognitive training can lead to~     improvements in speech perception for individuals with hearing loss. Individuals will~     complete 20 hours of cognitive training that is designed to improve cognitive abilities such~     as short term memory and attention. The investigators predict that cognitive training that~     improves the cognitive abilities affected by hearing loss will improve speech perception.~   "
58243|NCT02294799|"~     Background: Among the instrumental devices that have been proposed over the years to~     integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging~     techniques are the most studied, showing that magnetic resonance imaging (MRI) is the~     technique most need to describe the anatomy of the TMJ and to evaluate the correlation of~     imaging findings with the clinical diagnosis . Despite the amount available studies on the~     use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that~     evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of~     nonspecific mandibular mobilization about the positioning of the articular disc by MRI in~     individuals with TMD diagnosis of anterior disc displacement with and without reduction~     according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).~     Analyze the behavior of pain through the numerical scale of pain assessment (END) at~     baseline and after each treatment session, the quality of life of individuals with TMD at~     baseline, immediately, three and six months after the treatment sessions by the World Health~     Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific~     Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed~     three times a week during four weeks. Metodology: This is a randomized, placebo controlled,~     blind study designed to assess the effects of techniques nonspecific mandibular mobilization~     x placebo. Individuals will be randomized and divided into two groups: Group A~     (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular~     disc, extracted through the use of MRI, will be considered the primary outcome and, as a~     secondary outcome will be assessed the quality of life, pain and function after treatment.~     The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the~     data are expressed as mean values and standard deviation. Two-way repeated measures analysis~     of variance with Bonferroni post hoc test will be used for inter-and intra-group~     comparisons. The significance level is adjusted p ≤ 0.05.~   "
58244|NCT02294786|"~     Diarrhoea is the most commonly reported adverse events (AE) associated with Lapatinib~     treatment, and is also commonly associated with Capecitabine treatment. Although these~     events are generally mild to moderate in severity, diarrhoea adversely affects the~     tolerability of cancer treatment, and in severe cases diarrhoea has the potential to affect~     the efficacy of treatment due to poor compliance, or treatment interruption or withdrawal.~     The efficacy of Octreotide in the management of cancer treatment-associated diarrhoea has~     not been extensively evaluated in large, well-controlled studies. This is a randomised,~     multi-centre, open-label Phase II study in subjects with Human epidermal growth factor~     receptor 2 (HER2)-positive metastatic breast cancer which has progressed following prior~     therapy, which must have included anthracyclines and taxanes and therapy with Trastuzumab in~     the metastatic setting. This study is not placebo controlled, and there is no active~     comparator. The study will evaluate whether the prophylactic use of Octreotide Long Acting~     Release (LAR) offers a clinically meaningful benefit by reducing the frequency and severity~     of diarrhoea associated with treatment with Lapatinib and Capecitabine. Study completion for~     a subject will be defined as the completion of 24 weeks of treatment with Lapatinib and~     Capecitabine, or progression of cancer or the death of the subject during treatment,~     whichever occurs first. Approximately 140 subjects will be randomized out of which 70 will~     receive octreotide and 70 will receive no Octreotide~   "
58247|NCT02294747|"~     Trochanteric fractures represent about half of the hip fractures (with femoral neck~     fractures as the other half). Trochanteric hip fractures are almost always treated~     surgically with internal fixation of the fracture. However there is a debate ongoing for~     what is the appropriate implant to use. For stable fracture patterns the evidence seems to~     be in favor of the sliding hip screw, but for the unstable fractures it is more unclear~     whether to use a intramedullary nail or sliding hip screw with or without a lateral support~     plate (TSP). The role of the TSP in clinical use remains unclear and very little has been~     published about this, but it is believed to be an important contributor of stability to the~     sliding hip screw construct. We are planning a randomized controlled trial on trochanteric~     hip fractures to establish a method for implanting the tantalum markers, to observe the~     fracture healing process and to further investigate the role of the TSP.~   "
58248|NCT02294734|"~     The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition~     to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic~     Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety,~     tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks~     including screening, treatment period and a follow up visit. Subjects will receive once~     daily study treatment administration starting on Day 1. Study is planned to recruit~     approximately 120 subjects such that approximately 100 subjects complete the study.~   "
58249|NCT02294721|"~     The aim of this study was to compare four different CPR feedback devices to standard BLS in~     terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators~     hypothesis was that there would be no difference between CPR methods in terms of chest~     compression quality parameters.~   "
58250|NCT02294708|"~     The purpose of this study is to evaluate whether postoperative postures influence persistent~     sub-foveal fluid after scleral buckle surgery~   "
58251|NCT02294695|"~     To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after~     starting empirical antibiotic therapy in critically ill patients, to predict appropriate or~     inappropriate antibiotic treatment.~   "
58252|NCT02294682|"~     GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including~     ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized,~     multicenter, open-label, dose ranging study designed to inform the optimal oral dose of~     GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with~     uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned~     to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944.~     Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1)~     Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be~     approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in~     each treatment arm) will complete the study if both arms remain active throughout the study.~   "
58253|NCT02294669|"~     This is a prospective, exploratory study to verify intra-operative handling and safety and~     to collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a~     small bioresorbable device for the immediate immobilization of the facet joint.~      Patients eligible for study enrollment will present with degenerative lumbar spinal diseases~     involving the L4/L5 segment and requiring spinal fusion.~   "
58254|NCT02294656|"~     This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs.~     intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic~     cystoid macular edema (CME). Twenty consented patients with acute CME after~     phacoemulsification cataract surgery with posterior chamber intraocular lens implantation~     (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three~     monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3~     months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically~     in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident~     worsening of CME, combined with any of the following:~        -  Any increase in spectral domain ocular coherence tomography (OCT) central macular~          thickness (CMT)~        -  Any observable fluid on OCT~        -  Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).~      Patients will be followed monthly through 12 months.~   "
58255|NCT02294643|"~     The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in~     patients with CKD or DM after DES implantation.~   "
58256|NCT02294630|"~     Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause~     of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved~     means of surfactant delivery, requires endotracheal intubation and mechanical ventilation~     with their attendant risks. Interventions that decrease need for intubation and mechanical~     ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway~     pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are~     increasingly being used for initial respiratory support in preterm neonates with RDS to~     improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising~     concept for the treatment of RDS - retaining the advantages of early surfactant with~     alveolar recruitment while obviating the risks of intubation and mechanical ventilation. The~     investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in~     preterm infants undergoing NIV is safe and feasible and will result in short-term~     improvement in oxygenation and ventilation. The objective of this proposal is to perform a~     single-center unblinded Phase II randomized clinical trial of aerosolized surfactant for the~     treatment of RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.~   "
58257|NCT02294617|"~     The goal of this study is to get information from current smokers about how they feel~     towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will~     include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people~     stop smoking.~   "
58258|NCT02294604|"~     Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The~     traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or~     chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61%~     ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable~     antiseptic effect. The investigators perform a randomized controlled trial to compare the~     antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing~     with povidone-iodine and chlorhexidine solutions.~   "
58260|NCT02294578|"~     The investigators plan to recruit patients for a prospective study in patients in need of~     evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before~     diagnostic evaluation including biopsy with subsequent blinded examination of the salivary~     markers without knowledge of the disease status. This prospective recruitment with~     retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended~     by the National Cancer Institute for biomarker development. This process limits the~     selection bias that can confound retrospective studies. As the primary endpoint, a~     pre-specified multi-marker panel will be evaluated based on the combination of sensitivity~     and specificity. In addition, seven pre-specified individual candidate mRNA cancer markers~     and six internal reference or housekeeping genes will be evaluated. The performance of new~     multi-marker panels will also be assessed and compared with the prior pre-specified model~     based on sensitivity and specificity combinations as well as the area under the receiver~     operating characteristic curve.~   "
58261|NCT02294565|"~     The purpose of this Phase 1 portion of this clinical research study is to find out what dose~     of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to~     be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node~     Biopsy procedure) in patients diagnosed with breast cancer.~      The purpose of the Phase 2 portion of this clinical research study is to find out if giving~     dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can~     help surgeons localize the lymph nodes that need to be removed in patients diagnosed by~     breast cancer.~   "
58262|NCT02294552|"~     This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as~     graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in~     patients with different risk of GVHD. The risk-adapted strategy involves using single-agent~     cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide~     with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem~     cells and mismatched bone marrow.~   "
58263|NCT02294539|"~     The purpose of this study is to investigate which combination therapy is more effective for~     improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II~     receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics~   "
58264|NCT02294526|"~     Work hypothesis~      A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.~   "
58265|NCT02294513|"~     There is a strong connection between hearing loss and cognitive impairment, particularly~     dementia, in old age. Worldwide, dementia affects approximately 5% of persons over the age~     of 65 years. Hearing loss is even more prevalent in old age, affecting an estimated one~     third of persons over the age of 65 years. Thus, there is likely a large degree of overlap~     between the impairments. Indeed, this overlap may influence older adults' everyday~     functioning, communication, social engagement and quality of life, as well as influencing~     the well-being of their family caregivers. This project will examine whether patients with~     hearing loss and Alzheimer's disease, the most common form of dementia, derive benefit the~     from hearing aids prescribed and fit to them following current best practice procedures in a~     geriatric audiology clinic. For the first time, a formal evaluation of the potential~     benefits of hearing aids for the patients' family caregivers will also be conducted.~   "
58266|NCT02294500|"~     The study will collect the clinical and biological data of the patients, the investigators~     could further analyse and identify the risk factors and optimize clinical treatment method.~     Besides, population-based healthy people with informed consent are also collected.~   "
58267|NCT02294487|"~     This study will collect blood samples from healthy volunteers and volunteers with multiple~     myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB),~     and/or meningococcus vaccines.~      The main goal of the study is to start to identify differences in the immune response~     between multiple myeloma patients and people who don't have multiple myeloma. We hope this~     will provide important information about the best way and time to vaccinate multiple myeloma~     patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .~   "
58268|NCT02294474|"~     Primary Objective:~      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c~     (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM)~     also using insulin glargine.~      Secondary Objectives:~      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status~     and antibody titers at baseline and during the course of the study; To assess the~     relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of~     SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ≤6.5%,~     fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin~     dose.~      To assess safety of SAR342434 and Humalog.~   "
58269|NCT02294461|"~     Purpose of the study is to assess the effect of enzalutamide on time to Prostate Specific~     Antigen (PSA) progression as compared to placebo in chemotherapy naïve subjects with~     progressive metastatic prostate cancer who have failed androgen deprivation therapy~   "
58270|NCT02294448|"~     Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China), composed of~     processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae,~     Ovientvine, and Calculus Bovis Artifactus, has been developed and spread in use into~     clinical settings in 2009. As individualization has become the trend of modern medicine, a~     personalized medicine of Qishe Pill should be documented and practiced with various patients~     according to the ancient TCM system, a classification of personalized constitution type,~     which has been established to determine predisposition and prognosis to diseases as well as~     therapy and life-style administration. Therefore, we describe the population pharmacokinetic~     profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type~     (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of~     individualized and standardized Traditional Chinese Medicine into clinical practice.~   "
58271|NCT02294435|"~     The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use~     of the thoracic bifurcation and the visceral manifold or the unitary device to repair~     thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent~     of the study is to assess safety and preliminary effectiveness of the device. Additionally,~     the study will assess technical success and treatment success at each follow-up interval.~   "
58272|NCT02294422|"~     This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is~     traditionally used for identifying epidural space, is a better method for providing safe~     cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method~     is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is~     associated with airway damage.~      The study hypothesis states that both the loss of resistance syringe method and the pilot~     balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.~   "
58273|NCT02294409|"~     Social anxiety represents one of the most prevalent comorbid conditions in schizophrenia and~     related psychosis. Schizophrenia patients with comorbid social anxiety often exhibit~     impaired social functioning, an increased risk for relapse, and higher rates of suicide.~     Social anxiety is a treatable condition but has, in the context of psychosis, received only~     scant attention thus far. There is strong evidence that cognitive-behavioral therapy (CBT)~     for the treatment of social anxiety is very effective, whether it is delivered individually~     or in a group setting, and studies have shown that a group setting is more effective than~     individual therapy. Providing a CBT intervention for social anxiety represents an effective~     way to empower people with this illness.~      The investigators have conducted a preliminary study using an uncontrolled design to assess~     feasibility and initial benefits of a new manualized group CBT intervention for social~     anxiety specifically adapted for people with psychosis. The investigators observed a~     significant reduction in social anxiety symptoms across three groups of first episode~     psychosis (FEP) participants (n=29) following completion of this 13-week intervention, and~     observed large effect sizes confirming a significant positive influence of this~     intervention. The investigators now propose to conduct a randomized controlled trial to~     fully assess the efficacy of this intervention. The main objective of this research proposal~     is to contrast the impact of a CBT intervention for the treatment of social anxiety in first~     episode psychosis with another control condition involving computer assisted cognitive~     remediation therapy (CACRT). Both interventions will be offered in a group setting, and will~     therefore have the exact same parameters. A secondary objective of this study is to examine~     the impact of reduced social anxiety on measures of clinical and functional outcome.~      For this trial, 120 patients with recent onset psychotic disorder (defined as within 5 years~     from their first episode of psychosis) and with social anxiety will be clinically assessed.~     These participants will be recruited from five different first episode psychosis programs in~     the Montreal area and referred by their treatment team. They will then be randomly assigned~     to either the CBT or CACRT conditions. Both interventions will involve 13 weekly group~     sessions. At the end of group interventions and at two follow-ups (3-month & 6-month), the~     presence and severity of social anxiety symptoms will be assessed. It is hypothesized that~     compared to the CACRT group, individuals receiving the CBT intervention will show a~     reduction in symptoms associated with social anxiety (as determined with multiple~     self-report and clinician rated measures). This effect will be maintained at follow-ups. In~     addition, the investigators also hypothesize that the CBT group will show better clinical~     outcome, defined as the length of symptomatic remission at follow-ups. For functional~     outcome, they will show significant improvement on a self-report measure a clinician-rated~     measure of recovery. This study will be one of the first to specifically target social~     anxiety in people with psychosis using a psychosocial intervention. As such, it will tackle~     an important problem that is interfering with recovery and with the actualization of~     functional roles.~   "
58274|NCT02294396|"~     The objective of the study is to evaluate the safety and efficacy of add-on therapy with~     anticholinergics in patients with overactive bladder (OAB) on mirabegron.~   "
58275|NCT02294383|"~     The clinical study includes investigation of the outcomes of surgery for biomechanical~     restoration of pelvic floor conditions, monitoring pelvic floor conditions under~     conservative treatment/management, identification and investigation changes of pelvic floor~     muscle contractions and their significance in characterization of pelvic floor conditions,~     assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.~   "
58276|NCT02294370|"~     This study aims at improving the prediction of type 2 diabetes among high-risk individuals~     by examining glucose excursion patterns in subjects with impaired glucose tolerance. In~     addition, this study will show whether the currently used diagnostic test could be replaced~     by an easier and less expensive method.~   "
58277|NCT02294357|"~     The purpose of this Phase II study is to evaluate the safety and effectiveness (good and bad~     effects) of carfilzomib given as a 30-minute infusion and at a dose of 70 mg/m2 to treat~     patients with multiple myeloma (MM), who are currently showing progressive disease~     (worsening) and had progressed (did not respond to treatment) within 8 weeks of receiving~     treatment with 27mg/m2 of carfilzomib. Carfilzomib is approved by the U.S. Food and Drug~     Administration (FDA) to be used only in certain U.S. patients with relapsed and refractory~     multiple myeloma that have tried and failed other therapies. Carfilzomib is considered an~     investigational drug for this study because the dose and regimen included in this study are~     different from the FDA approved carfilzomib regimen. Carfilzomib is a type of drug called a~     proteasome inhibitor. Carfilzomib is thought to work by preventing breakdown of abnormal~     proteins in cells, causing the cells to die. Cancer cells are more sensitive to these~     effects than normal cells. Carfilzomib has been previously given to more than 1800 people in~     clinical trials.~   "
58278|NCT02294344|"~     The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with~     antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).~   "
58279|NCT02294331|"~     Lead survivability will be summarized.~   "
58280|NCT02294318|"~     This pilot study goal is to compare two different treatments to help HIV positive patients~     reduce their concurrent drinking and non-injection drug use.~   "
58281|NCT02294305|"~     This placebo-controlled study is designed to determine the efficacy, safety, and~     tolerability of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD)~     that is comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized~     to receive vortioxetine and the other half will receive placebo.~   "
58282|NCT02294292|"~     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with~     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset~     of complications in liver disease. The purpose of this prospective, randomized controlled~     trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left~     ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal~     dysfunction, worsening cardiac function, and mortality).~   "
58283|NCT02294279|"~     Nitric Oxide is recognized as a biological marker for many chronic airway diseases. It has~     been standardised for clinical use indicating airway inflammation.~      In clinical practice, FeNO can aid confirmation of an asthma diagnosis and can indicate the~     degree of steroid-responsiveness. This can help guide physician decisions on the initiation~     of inhaled corticosteroid (ICS) therapy, or adjustment of ICS therapy.~      Therefore, FeNO measurement could be particularly useful to confirm an asthma diagnosis in~     patients with non-specific respiratory symptoms (≥ 6 weeks of cough and/or wheezing and/or~     chronic dyspnoea) and to assess how likely they are to benefit from corticosteroid~     treatment.~      This study will assess the suitability of FeNO to predict ICS responsiveness in patients~     with non-specific respiratory symptoms.~      Additionally, we would like to determine the suitability of FeNO as a diagnostic tool for~     asthma in comparison to conventional predictors, e.g. spirometry.~   "
58284|NCT02294266|"~     The purposes of this study are 1) to evaluate the pharmacological effects after oral~     coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of~     mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.~   "
58285|NCT02294253|"~     The investigators will randomize 50 opioid-dependent participants who have initially failed~     outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a~     weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day~     stabilization and twice weekly during taper phase, and all patients who successfully~     complete the detoxification will be offered induction onto XR-NTX. All participants will~     receive weekly therapy with a study psychiatrist. All participants will receive open-label~     medication. The primary outcome of this study will be percentage of patients successfully~     inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or~     dropout.~   "
58286|NCT02294240|"~     A nutrition trial which is based on the evidence that multivitamins & micro nutrients~     provided during pregnancy in malnourished women will improve neonatal birth weight. There~     will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI <20~     & gestational age less than 14 weeks. The other arm with same criteria will be provided with~     wheat flour, oil, iron & folic acid. Neonatal birth weight is the primary outcome of~     interest but maternal weight gain, maternal hemoglobin & ferritin levels and palatability of~     biscuits will also be assessed.~   "
58287|NCT02294227|"~     The purpose of this study is to provide 16-week efficacy, safety and tolerability data~     versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)~     self-administration with or without a loading regimen and maintenance dosing using~     pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in~     subjects with active AS despite current or previous NSAID, non-biologic DMARD or biologic~     anti-TNFα therapy~   "
58288|NCT02294214|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence~     between intervention and control arms.~   "
58289|NCT02294201|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence~     between intervention and control arms.~   "
58290|NCT02294188|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence~     between intervention and control arms.~   "
58291|NCT02294175|"~     This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers~     who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x~     2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during~     an 8 day study period.~   "
58292|NCT02294162|"~     Pain is an unpleasant sensory experience associated with actual or potential tissue damage.~     Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it~     is the most important factor related to patient discomfort after surgery. Adequate pain~     management, ideally resulting in the complete absence of postoperative pain, not only~     provides comfort to patients, but may also contribute to improved healing and a reduction in~     the incidence of postoperative complications. Inadequate postoperative analgesia has been~     shown to contribute to adverse outcomes, including, but not limited to, immunosuppression,~     hyperglycemia, poor rehabilitation, and progression to chronic pain.~   "
58293|NCT02294149|"~     The purpose of this study is to determine whether administration of mammalian Omega 3~     FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due~     to chemotherapy.~   "
58294|NCT02294136|"~     End-stage liver disease, predominantly due to hepatitis C virus (HCV) infection, is one of~     the leading causes of death in person living with HIV infection. While HCV is curable and~     recent advances in treatment have increased the rates of cure, few patients with HIV and HCV~     are being treated to cure HCV. Based on formative research, the investigators developed the~     Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C).~     PREP-C is a clinical interview that healthcare providers of diverse disciplines can be~     trained to administer. It provides an assessment of a client's psychosocial readiness to~     begin HCV treatment and identifies domains of functioning which require intervention to~     improve treatment readiness. PREP-C (www.prepC.org) is also a telemedicine resource for~     health care providers. Under this protocol, the existing PREP-C clinical interview (or~     assessment) is incorporated with a behavioral intervention. This study tests the integrated~     assessment-behavioral intervention to increase HCV treatment initiation among~     HIV-co-infected patients. The assessment-behavioral intervention under this protocol is~     conducted in two phases, an Intervention Development phase and a Pilot Randomized Clinical~     Trial (RCT) phase.~      Findings from this vanguard study will inform the design parameters of a larger, more~     rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based~     assessment and intervention package is designed to be scalable and can be disseminated~     through the live PrepC.org web site. The proposed study is innovative in that it seeks to~     develop the first web-based intervention for health care providers to use to increase HCV~     treatment initiation in HIV/HCV-co-infected persons. The study can have a major public~     health impact by providing needed structured resources for health care providers to increase~     rates of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality~     due to end-stage liver disease.~   "
58295|NCT02294123|"~     Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one~     traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with~     diabetes, or overweight or clinically healthy.~      Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of~     participants will be included for each category (n = 27 in each group): 1) adults with~     diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and~     insulinemic index will be measure for each group of participants given in random order the~     following foods: 1) a whole corn tortilla (white criollo corn= 5.3% fiber), 2) a whole~     corn tortilla (white hybrid corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and~     4) white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn~     will be follow the FAO methodology. For the evaluation of each food left the range of 1~     week.~   "
58296|NCT02294110|"~     Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia~     failure. However, that opinion was not determined in a trial. Thus the investigators aimed~     to investigate the effect of diabetes mellitus on spinal anesthesia.~   "
58297|NCT02294097|"~     The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains~     unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients~     with standard approach which allograft biopsy was performed only when indicated.~   "
58509|NCT02291341|"~     This study were to compare the relative bioavailability of Duloxetine HCl delayed release~     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed~     release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor~     safety of subjects~   "
58298|NCT02294084|"~     The obesity epidemic has resulted in an exponential increase in obesity-related disorders~     including type 2 diabetes, dyslipidemia and cardiovascular disease. The associated morbidity~     and mortality have major consequences both at an individual as well as on the~     socioeconomical level. Thus, the development of novel therapies aimed at reducing the~     development of obesity is highly warranted. Brown adipose tissue (BAT) recently emerged as a~     novel player in energy expenditure in humans as it combusts fatty acids towards heat.~     Interestingly, obese subjects have less BAT as compared to lean subjects and activation of~     BAT by means of intermittent cold exposure reduces fat mass. Therefore, BAT is considered a~     promising novel target to reduce obesity and associated disorders. As cold exposure is not~     the most desired therapeutic strategy for humans, current pre-clinical research focuses on~     pharmacological activation of BAT.~      Interestingly, the investigators have recently shown that central agonism of the receptor~     for the incretin hormone glucacon-like peptide-1 (GLP-1) results in activation of BAT in~     mice. One of the currently used anti-diabetic drugs that enhances GLP-1 availability is~     Sitagliptin (STG). Interestingly, STG also reduces body weight and plasma triglyceride (TG)~     levels in type 2 diabetes mellitus (T2DM) patients. The mechanism underlying these~     beneficial metabolic effects is currently unknown. The investigators hypothesize that STG~     enhances BAT activation, thereby increasing energy expenditure and combustion of TG-derived~     fatty acids, resulting in lowering of plasma TG levels and body weight.~      To this end, the investigators will perform a randomized double-blinded placebo-controlled~     study in which 30 male Dutch Caucasian adults aged 35-50 years with moderate obesity and~     pre-diabetes are included. Subjects will be treated for 12 weeks with STG or placebo. Before~     and after treatment, the investigators will determine BAT volume and total BAT activity via~     cold-induced 18F-FDG PET-CT scans, resting energy expenditure via indirect calorimetry using~     ventilated hoods, body weight, and body composition via DEXA scan. Furthermore, before and~     after treatment, blood samples will be taken to measure plasma lipids, glucose and insulin~     levels.~      This study will offer valuable novel insight in the effects of pharmacological activation of~     BAT in human obese subjects.~   "
58299|NCT02294071|"~     This study will examine in detail the immediate effects of three common treatments given to~     children with fevers to lower their temperature. Each child will be given either ibuprofen,~     acetaminophen, or a combination, and their temperature monitored at five-minute intervals.~     The temperature-lowering effects of each treatment will be compared to evaluate which is~     most effective.~   "
58300|NCT02294058|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
58301|NCT02294045|"~     Clinical-noninvasive recording of sounds from the knees through a brief loaded range of~     motion. Description in phase 1 analytic but descriptive as well in phase 2. No samples other~     than a sound recording. The device is known microphone attached to the skin of the knee with~     elastic material. Sound recorded and analyzed on a lap top computer with Adobe software.~   "
58302|NCT02294032|"~     The purpose of this study is to understand the role of specific B cells in activating or~     repressing an anti-allograft immune response after kidney transplantation. In this study,~     blood will be collected from kidney transplant patients during different timepoints, prior~     to and after their transplant. Knowledge gained from study findings will be used to develop~     therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of~     long-term graft loss in kidney transplant patients.~   "
58303|NCT02294019|"~     This is an open label, multicenter, 30 day study designed to mimic an OTC like environment~     in which subjects will use the product after making a purchase decision about ibuprofen 400~     mg caplets based only on their reading of the Drug Facts Label (DFL) and other information~     on the package.~   "
58304|NCT02294006|"~     Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine~     activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has~     been implicated in the proliferation of pNET ( primitive neuroectodermal tumor) cells.~     Everolimus ,an mTOR inhibitor (a central regulator of growth/proliferation, cellular~     metabolism and angiogenesis) has shown antitumor benefit in pNETs alone and in combination~     with Octreotide LAR in RADIANT-1 and RADIANT-3 studies.~      Despite EVE-based phase II/III trials improve progression-free survival (PFS) for pNETs,~     they are limited to significantly prolong overall survival (OS). Metformin has recently~     shown some anti-cancer activity, both in vitro and in vivo studies by antisecretory~     properties to decrease insulin and IGF1 levels; and by antitumor effect due to AMPK~     (adenosine monophosphate kinase) activation and consequently inhibition to TSC1(tuberous~     sclerosis complex 1) -2/mTOR complex, mediated to LKB1 oncogene expression. The~     investigators retrospective experience, despite in a limited group of pWDNET, highlights the~     role of MET to improve clinical benefit in diabetic pts receiving EVE-OCT (octreotide)~     combination.~      This study will investigate the antiproliferative potential of MET in combination with EVE~     and OCT in pWDNETs. MetNET1 prospective trial (EudraCT 2014-000888-41) may be helpful to~     either confirm or discard these preliminary findings.~      The main objective of this study is to evaluate progression free survival rate at 12 months~     of treatment. The secondary objectives are safety, overall survival, response rate~     evaluation.~      A sub-study analysis will evaluate circulant biomarkers levels (IL 6, IGF1) in blood~     samples.~   "
58305|NCT02293993|"~     To evaluate the tolerability and pharmacokinetics of SGI-110 when administered~     subcutaneously to Japanese patients with acute myeloid leukemia (AML).~   "
58306|NCT02293980|"~     PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD)~     of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients~     with advanced clear cell renal cell carcinoma (ccRCC).~      PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to~     the RP2D, in combination with nivolumab, in patients with advanced ccRCC.~      PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to~     the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.~   "
58307|NCT02293967|"~     The purpose of this study is to investigate the absorption, metabolism and excretion of~     MT-1303 in healthy subjects.~   "
58308|NCT02293954|"~     This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA)~     monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA~     positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody~     M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard~     diagnostic methods.~   "
58309|NCT02293941|"~     The primary objective of this study is to assess changes in alanine aminotransferase (ALT)~     in hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who~     have been nonresponsive to, intolerable to, or relapsed from prior interferon-based~     therapies (pegylated or standard) either alone or in combination with ribavirin or other~     anti-HCV therapies including direct-acting anti-viral agents.~   "
58680|NCT02289092|"~     The Positive Family Support Project seeks to understand some of the factors that increase~     success for children in early elementary school, such as positive family support at home.~     This study will inform us on ways to help children learn and succeed in school.~   "
58310|NCT02293928|"~     The effect of antiplatelet therapy is impaired among patients, who recently underwent~     on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization~     using minimal invasive surgical techniques on the antiplatelet effect of aspirin and~     clopidogrel remains unclear.~      The aim of the study is to describe the impact of hybrid coronary revascularization on the~     effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline~     platelet aggregation, high postoperative levels of platelet turnover and acute-phase~     response may contribute to the effect.~   "
58311|NCT02293915|"~     The primary purpose of this study is to determine the efficacy and safety of Sodium~     Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.~   "
58312|NCT02293902|"~     Primary Objective:~      To demonstrate that sarilumab added to MTX reduce signs and symptoms of rheumatoid arthritis~     (RA) in Japanese RA patients with an inadequate response to MTX.~      Secondary Objective:~      To assess the safety of sarilumab added to MTX in Japanese RA patients with an inadequate~     response to MTX.~   "
58313|NCT02293889|"~     Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of~     increasing age and body fat. As there are no very effective therapies for KOA, disease often~     progresses until knee replacement surgery is needed. It has been observed Vitamin D and~     Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As~     the relationship between KOA, Vitamin D and PA levels are not clearly understood, this study~     aims to explore these relationships and the acceptability/feasibility of PA and Vitamin D~     interventions in those who would likely to benefit from these interventions.~      200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR)~     KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November~     2014-January 2016 to participate in a single cross-sectional study visit, which will~     measure: Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain~     (by questionnaire), and PA levels.~      Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min~     moderate PA/week), will be invited to take part in a 3 month pilot RCT study.~      >64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4~     intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a~     day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week~     study visit, up to 20 participants will be invited to take part in a qualitative interview~     exploring their experience during the two studies.~   "
58314|NCT02293876|"~     The purpose of the study is find out the better measure to achieve corneal protection in an~     Intensive Care Unit.~   "
58315|NCT02293863|"~     This is a randomized, double-blind, placebo-controlled study that will investigate the~     safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult~     participants hospitalized with severe influenza A in combination with oseltamivir versus a~     comparator arm of placebo with oseltamivir.~   "
58316|NCT02293850|"~     This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative~     phase I/II trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 33~     patients will be recruited in this study. By utilizing a Simon optimal two-stage design, up~     to 69 patients will be enrolled into this study, while considering the 20% drop-out rate, in~     order to target 19 response-evaluable patients for the first stage and additional 36~     response-evaluable patients for the second stage in phase II part study.~   "
58317|NCT02293837|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study~     doctors think that giving medicines to affect the immune system soon after diabetes is~     diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better~     glucose control.~      Researchers believe that tocilizumab could have some effect on the cells in the immune~     system that are thought to be involved in the development of type 1 diabetes. This study~     will test whether tocilizumab can help preserve or delay destruction of remaining beta cells~     in people recently diagnosed type 1 diabetes.~   "
58318|NCT02293824|"~     Almost all infants born <29 weeks gestational age develop apnea of prematurity and are~     treated with caffeine. Type of diet and disease states may be significant contributors of~     variability in caffeine metabolism and pharmacokinetics (PK) in this population. This~     prospective, observational, open-label, opportunistic PK study will compare the population~     PK of caffeine between infants fed formula and infants fed exclusively breast milk; compare~     the activities of caffeine metabolizing enzymes between infants fed formula and infants fed~     exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on~     caffeine PK and metabolism in premature infants.~   "
58319|NCT02293811|"~     The inflammatory tumor micro-environment is a consequence and a driver of tumorogenesis. On~     one hand it promotes antitumor immune responses and on the other hand it favors development~     and progression of cancerous lesions.~      Factors regulating the complex interplay between epithelial and immune cells are still~     poorly characterized. Extracellular ATP (eATP) acting on the purinergic P2X7 receptors~     (P2RX7) has recently emerged as a key signaling pathway in the immune response.~      Recent data have revealed the crucial role of P2RX7-NLRP3-Caspase-1 for priming dendritic~     cells (DC) within the tumor microenvironment upon treatment with certain types of~     chemotherapy drugs. Despite this important discovery, no previous study has so far~     investigated the global in vivo effect of P2RX7 modulation in inflammation-induced~     carcinogenesis of mucosal tissues.~      Our consortium, endowed by a long standing experience in the field of mucosal immunology,~     inflammation and signaling, already demonstrated that the P2RX7 is differentially expressed~     in the mucosa of patients with active and quiescent inflammatory bowel disease (IBD), where~     eATP is present at very high concentration, and that P2RX7 controls an amplification loop of~     the inflammatory response (Cesaro et al., 2010). Furthermore, we uncovered that P2RX7~     controls homeostasis, survival and function of regulatory T cells (Hubert et al., 2010). In~     addition, our recent demonstration that P2RX7 deficiency lowered mucosal inflammation but~     unexpectedly enhanced tumor formation in vivo warrants additional efforts to explore the~     molecular and cellular mechanisms accounting for this effect and suggest that enhancing~     P2RX7 function may have an anti-tumor therapeutic effect.~      These observations emphasize the tumor suppressor role of P2X7 receptor, warrant further~     investigation to better understand the molecular mechanisms responsible for this anti-tumor~     effect and suggest that enhancing the function of P2X7R could have a therapeutic effect~     significant antitumor.~      Our main objectives is to explore the role of P2RX7 in healthy, inflammatory and cancerous~     colonic mucosa. For this we will map the expression of the protein P2RX7 and realize~     genotype of P2RX7 forms in inflammatory diseases and cancer of the colon.~   "
58320|NCT02293798|"~     The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold~     to maintain the size of the areola by providing additional soft tissue support after~     circumferential periareolar mastopexy.~   "
58505|NCT02291393|"~     The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80~     lead ECG may increase the specificity and sensitivity in diagnosing this potentially life~     threatening inherited cardiac condition. This pilot would form the basis of a much larger~     clinical trial to test the utility of this novel diagnostic tool.~   "
58321|NCT02293785|"~     The symptoms associated in advanced cancer patients and adverse events due to use of opioids~     have major influence on the state of health and quality of life of patients. The pain, in~     particular, is a symptom with severe negative impact and with a prevalence ranging between~     33% and 64%, according to the stage of the disease, with values around 70-90% in advanced~     stages and metastatic.~      The use of opioids, however, is usually associated with the appearance of common adverse~     events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects~     are self-limiting in the time for the appearance of tolerance while others, as constipation~     persist.~      Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN),~     which consists in the union between a molecule agonist and an antagonist of opioid~     receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared~     to oxycodone alone.~   "
58322|NCT02293772|"~     A loss of body weight has been documented in lowland-living individuals when exposed to~     hypoxic environments, such as at high altitude, or under laboratory conditions. A reduction~     in appetite and energy intake has also been reported during conditions of microgravity, such~     as during space flight. Fourteen normal or over-weight men, who are otherwise healthy, will~     undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%), normobaric~     hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and normobaric~     hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on appetite and its~     hormonal control will be assessed before and at day 17 of each intervention using a mixed~     meal tolerance test.~   "
58323|NCT02293759|"~     Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal~     bleeding profile.~      Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based~     on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller~     prostates will be treated with greenlight PVP~   "
58324|NCT02293746|"~     The purpose of this study is to obtain additional safety and efficacy data on the use of~     Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep~     Apnea.~   "
58325|NCT02293733|"~     The purpose of our retrospective study is to describe which circumstances EGFR TKI is~     continued despite progression according to the usual Response Evaluation CrIteria in Solid~     Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR~     TKI .We will collect their social and demographic data (age, sex), first Progression Free~     Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first~     progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from~     diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more~     closely the mode of progression (site), the therapeutic approach at disease progression. We~     will define two subgroups: those for whom EGFR TKI was continued at least three months~     despite progression defined according to RECIST criteria, and those for whom a second-line~     treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be~     individualized the subgroup of patients in whom it was continued TKI after progression.~   "
58326|NCT02293720|"~     A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the~     EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from~     study #09-1 who are not treatment failures and have completed 12 months of the study.~   "
58327|NCT02293707|"~     GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme~     playing an essential role in cancer cell proliferation.~      This clinical trial will test three different GX301 administration regimens in~     castration-resistant prostate cancer patients who have achieved response or disease~     stability with first-line docetaxel treatment. This is aimed at identifying an optimal~     vaccination regimen.~      The three regimens will primarily be compared for their efficacy and safety in inducing~     vaccine-specific immunological responses over a period of 6 months following treatment~     initiation. In addition, patients will be observed for the occurrence of disease progression~     and for their vital status up to 24 months.~   "
58328|NCT02293694|"~     The feasibility of Sayana Press self-injection and the potential for this practice to~     increase contraceptive continuation has never been assessed in family planning programs in~     low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for~     International Development (USAID) Malawi Mission requested the Advancing Partners and~     Communities (APC) project to assess self-injection of Sayana Press to inform their~     decision-making for procurement of Sayana Press and distribution through the health system~     in Malawi.~   "
58329|NCT02293681|"~     The purpose of this observational (a study that follows participants forward in time) study~     is to compare the functional improvement of hip joint using Harris hip score between 2~     treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis~     (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment~     points) participants with hip involvement.~   "
58330|NCT02293668|"~     There are different controlled ovarian hyperstimulation protocols utilized in infertility~     patients. In this study, our aim is to specifically compare three protocols in poor~     responding infertility patients.~   "
58331|NCT02293655|"~     This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH)~     in children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to~     either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.~   "
58332|NCT02293642|"~     Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of~     its validity and responsiveness.~   "
58333|NCT02293629|"~     This is the first clinical study with the BMS-986147 compound in healthy subjects. The~     purpose of this study is to guide the dose range and dose frequency for future studies with~     BMS-986147 and will provide guidelines for selection of a potentially effective dose in~     patients.~   "
58391|NCT02292875|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed~     all dosing visits in study TG002 approximately two years after the start of treatment.~   "
58334|NCT02293616|"~     It is well documented that intensive care unit (ICU) patients have lower levels of skeletal~     muscle strength compared to non-ICU patients upon hospital discharge, and this weakness~     affects the patient's ability to perform basic activities of daily living upon hospital~     discharge and for extended periods thereafter. Recently, critically ill ICU patients have~     been shown to have lower nitric oxide levels. These patients often suffer from a disturbed~     homeostasis with circulatory and metabolic abnormalities that may potentially contribute to~     their ICU acquired weakness. Given the recent research showing dietary nitrate~     supplementation can increase nitric oxide levels and improve exercise tolerance in healthy~     and diseased older individuals, our aim is to investigate the importance of nitrate~     supplementation in ICU patients with focus on physical function and ICU acquired muscle~     weakness.~   "
58335|NCT02293603|"~     To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary~     infusion in subjects with DCM. The study will further explore safety and exploratory~     efficacy endpoints of CAP-1002.~   "
58336|NCT02293590|"~     Tight control of an adaptive concomitant treatment strategy after initiation of CZP will~     lead to an improved outcome of RA patients with an active disease despite DMARD treatment.~   "
58337|NCT02293577|"~     The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day~     to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM~     will identify caloric and exercise related variation in blood glucose that is not identified~     by the subjects' current regimen of intermittent finger stick blood glucose measurements.~   "
58338|NCT02293564|"~     The purpose of this study is to evaluate the long-term safety of gevokizumab in the~     treatment of active inflammatory, erosive osteoarthritis of the hand.~   "
58339|NCT02293551|"~     The purposes of this study are to determine:~        -  Part A~             -  How quickly your body absorbs, breaks down and gets rid of the different~               formulations of insulin lispro compared to insulin lispro alone formulation.~             -  The safety of insulin lispro in different formulations and any side effects that~               might be associated with it.~        -  Part B:~             -  How much insulin lispro from different dose ranges is found in the bloodstream~               using a test insulin lispro formulation (selected from Part A).~             -  The safety of insulin lispro in different formulations and any side effects that~               might be associated with it.~      Participants may only enroll in one part. The study is expected to last up to 10 weeks for~     each part.~   "
58340|NCT02293538|"~     The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer~     after 2 hours of lens wear with use of FID 114657 compared to saline control.~   "
58341|NCT02293525|"~     The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion~     catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the~     patients will receive continuous local analgesic fusion during the post-operative period~     while the other half will received continuous local saline.~   "
58342|NCT02293512|"~     Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability among~     Veterans. A range of clinical interventions has been created to systematically address the~     range of issues caused by tinnitus. While numerous interventions purport to promote coping~     strategies for tinnitus-related problems, few studies directly target and measure coping~     outcomes. The present pilot study proposes a comparison of coping outcomes after 3~     psycho-educational groups: a cognitive-behavioral therapy (CBT) intervention, a Coping~     Effectiveness Training (CET) intervention, or an Acceptance and Commitment Therapy~     intervention among Veterans with tinnitus. These groups will be compared to a usual care~     group among Veterans and civilians with tinnitus. The proposed study will be the first~     application of CET to tinnitus. The primary goals of this study are to develop a CET~     protocol for tinnitus and to evaluate the effectiveness of CBT, CET, and ACT interventions~     to a usual care group. The long-term goal of this study is to improve the quality of life~     among individuals with tinnitus.~   "
58343|NCT02293499|"~     Asthma is a serious chronic health condition particularly in inner-city adolescents, who~     suffer disproportionately high asthma-related morbidity and mortality that place heavy~     economic burdens on families and society. There is a consensus that adverse asthma outcomes~     can be ameliorated by an individual's active engagement in adequate self-management. This~     multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma~     self-management for adolescents (PLASMA) program that has demonstrated its feasibility and~     preliminary efficacy in a previous study. PLASMA will be implemented in three cities~     (Buffalo NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric~     asthma and asthma-related morbidity, and are thus most likely to benefit from the program.~     PLASMA comprises three main components: (a) peer-leader training; (b) a one-day asthma camp~     where peer leaders will deliver manualized self-management content recommended by the~     national guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to~     evaluate the effectiveness of PLASMA in inner-city adolescents with asthma in improving~     quality of life (primary outcome), and asthma knowledge, attitudes, outcome expectations,~     self-efficacy, self-management skills, and asthma control, FEV1 (exploratory outcomes) over~     time, compared to a control group for whom adult leaders will deliver the same program~     content; (2) to examine the mediating effects of the exploratory outcomes on quality of~     life; (3) to examine the moderating effects of personal factors (e.g., age, sex, family~     support) on the intervention's primary and exploratory outcomes; (4) to evaluate the effects~     of PLASMA on study outcomes in peer leaders (16-20 years); and (5) to determine the economic~     impact of the intervention. These aims will be accomplished using a two-group randomized~     controlled trial with 378 adolescents (12-17 years) from the three cities (126 for each~     site). A total of 42 qualified peer leaders (14 in each site) will be enrolled based on~     adult nomination. Eligibility criteria for both peer leaders and adolescent learners~     include: a current asthma diagnosis; persistent asthma; absence of other chronic or mental~     illness; inner-city residence; and capability of verbal and written communication in~     English. Participants will provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-,~     12-, and 15-months post-camp (T3-T7). Data will be analyzed using a multi-site hierarchical~     three-level linear mixed-effects model where level 1 represents repeated measures, level 2 =~     subject, and level 3 = site. To determine the economic impact of the program, investigator~     will measure the direct healthcare costs and total costs of the program, and perform net~     cost analyses for each type of costs. In addition, investigator will estimate~     cost-effectiveness ratios of the PLASMA group compared with the control.~   "
58344|NCT02293486|"~     The purpose of this study is to evaluate modifications of plasma protein carbonyls and~     malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice~     consumption.~   "
58345|NCT02293473|"~     This study is designed to test if measuring the depth of anaesthesia, brain tissue~     oxygenation and haemodynamic parameters and specially designed interventions according to~     the measurements can improve the outcome of high risk surgical patients undergoing major~     abdominal surgery.~   "
58346|NCT02293460|"~     Primary objective:~      To assess the efficacy of I10E in improving the disability of patients with CIDP.~      Secondary objective:~      To assess the safety of I10E in patients with CIDP.~   "
64322|NCT02215395|"~     To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of~     a single dose and multiple doses of antimycotic co-medication (miconazole nitrate~     suppository or cream).~   "
58347|NCT02293447|"~     Uterine artery embolization (UAE) is a minimally invasive treatment for women with~     symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms~     improvement, with fewer complications and at lower cost. However, the majority of women~     undergoing UFE experience important pain after the procedure despite optimal analgesia, with~     one third reporting pain equal or worse than labor. Pain is the more common cause of~     prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce~     post-procedural pain.~      For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine,~     injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3~     groups: control, lidocaine injected during embolization, and lidocaine injected after~     embolization. Pain will be evaluated using a validated scale at 4h and 24h~     post-intervention. Hospital length-of-stay and total narcotic dose administered will be~     evaluated in the three groups.~      This is the first Canadian study evaluating lidocaine use for pain control in UFE patients.~     Results will be transferable to clinical practice, considering the use of lidocaine is~     simple and cost is negligible. It could have a great impact on pain management in women~     undergoing UFE in all practice settings.~   "
58348|NCT02293434|"~     Study rationale: Children admitted to intensive care are often chronically ill and the~     intensive care setting may upset the balance between nutritional intakes and needs.~      As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units~     (PICUs), screening for malnutrition and the individualized adaptation of nutritional support~     are important elements of patient care. Yet no recent study has evaluated the nutritional~     status of children admitted to PICUs in France.~      Primary Objective: Determine the prevalence of malnutrition in the population of children~     admitted to intensive care.~      Secondary objectives:~        -  Determine the children's nutritional status on admission.~        -  Characterize the profile of malnourished patients compared with those not malnourished~          (sex, age, history, chronic disease, usual dietary habits, reason for admission,~          scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).~        -  Describe the practices regarding nutritional care in each center.~      Population: All children (1 month to 18 years) admitted to all PICUs in France during three~     one-week periods (February, June, October) in the course of a year.~   "
58349|NCT02293421|"~     Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA~     is associated with a large number of co-morbidities, and thus, it is of great importance to~     identify the patients and start treatment in order to reduce the risks for complications.~     Current screening tools are quite unspecific and the golden standard methodology for~     diagnosis, polysomnography, is expensive and time consuming, thus not suitable for~     screening. In perioperative medicine the STOP BANG screening questionnaire is currently the~     recomended screening tool, however this questionnaire has only been evaluated in a sleep~     clinic in a very limited numbers of patients.~   "
58350|NCT02293408|"~     The objectives of this study are to describe the clinical and biochemical characteristics~     and course of disease progression in patients with MPS IIIB~   "
58351|NCT02293395|"~     The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared~     with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine~     diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in~     participants with a recent acute coronary syndrome (ACS: including ST segment elevation~     myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome~     [NSTE-ACS]).~   "
58352|NCT02293382|"~     The objective is to perform a retrospective chart review to generate data to evaluate the~     clinical characteristics and course of disease progression of MPS IIIB.~   "
58353|NCT02293369|"~     American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive~     methods in gynecological surgery to ensure increased benefits to the patient and reduce~     potential hospitalization costs.~      Laparoscopic hysterectomy has become the standard approach in gynecological benign~     disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different~     sutures, techniques and approaches, which is one of the challenges of this surgery. Data is~     limited on potential impact of different sutures, techniques and approaches for vaginal cuff~     closure on female sexual function in relation to vaginal length.~      Various studies in the literature evaluated different approaches (abdominal, vaginal,~     laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different~     techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures~     like operation time, cuff healing, complications, cost effectiveness, etc. were usually~     measured. However, there is no prospective randomized clinical study in the literature that~     compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual~     function in relation to vaginal length.~   "
58354|NCT02293356|"~     This clinical study is designed as an open, single group, multi-center, phase 4 clinical~     study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and~     to provide a more reasonable basis for clinical drug programs.~   "
58355|NCT02293343|"~     Over 24 hrs we collect serum and plasma samples every 3 hrs. With this we create a day~     histamine profile. We compare 15 healthy persons with 20 patients with a high level of IgE~     in serum and 20 patients with afflictions but no high IgE level. We measure histamine in~     plasma, urine and stool. In addition to that we measure diaminoxidase, TNF alpha and IgE~     Antibodies.~   "
58356|NCT02293330|"~     This study is developed to determine if the local anaesthetic dose can be reduced by the use~     of intermittent bolus technique compared to continuous infusion when the nerve catheter is~     placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary~     outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve~     catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is~     necessary the first postoperative 48 hours after surgery for adequate postoperative~     analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory~     block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during~     the nerve block and afterwards.~   "
58357|NCT02293317|"~     This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001~     in thirty six (36) volunteers 50-65 years of age.~      All subjects will receive an intramuscular (IM) injection, in each one of three visits, with~     a 21±2 days interval between treatments.~   "
58358|NCT02293304|"~     The aim of this study is to evaluate the 18-month clinical performance of a multimode~     adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after~     partial carious removal. This randomized clinical trial will include subjects (5-10 year-old~     children) selected at two university centers (UFSM and FOUSP). The sample will consist of~     132 primary molars presenting active cavitated carious lesions (with radiographic~     involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal~     surface. The sample will be randomly divided into two groups according to bonding approach:~     etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6~     months for up to 18 months using the USPHS modified criteria for clinical evaluation.~     Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier~     method.~   "
58359|NCT02293291|"~     Although thermal therapy has been utilized in the rehabilitation of war veterans since the~     Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This~     due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist~     in thermal therapy which is the primary objective of this investigation.~   "
58360|NCT02293278|"~     The purpose of this pilot study is to test the efficacy of the physical activity (PA)~     intervention protocol to increase preschoolers overall PA levels and time spent in moderate~     to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy~     Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement~     based activities developed for preschoolers and successfully piloted for feasibility in 3 to~     5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As~     well, the PA intervention includes educational workshops for the day care providers, ongoing~     biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment~     necessary to implement the program. The study is also evaluating the efficacy of the PA~     intervention to decrease the amount of time spent in sedentary behaviour at the day care~     setting.~      Secondary objectives include evaluating the effects of the PA intervention on preschool~     children's anthropometrics, and fundamental and gross motor skills. In addition, the~     intervention is also assessing the effects of the program on day care provider's attitudes,~     control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.~   "
58361|NCT02293265|"~     This will be a non-drug interventional cross-sectional study, where the screening visit and~     study visit can occur on the same day. Investigational product will not be administered.~     Approximately 790 subjects with severe asthma will be screened to achieve a total of at~     least 750 evaluable study subjects. The study will not include a run-in or follow-up period.~     This study will provide a more reliable description of the severe asthma patient landscape~     with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and~     reslizumab. This study aims to estimate the potential overlap of patients eligible for~     treatment with mepolizumab and those eligible for treatment with omalizumab and/or~     reslizumab. Additionally, the current study will also ascertain and describe reslizumab~     eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient~     population.~   "
58362|NCT02293252|"~     The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the~     combined clinical endpoint days alive and not in hospital nor stationary care per days in~     study and the change in total cost compared to that of the control group.~   "
58363|NCT02293239|"~     This study evaluates the effects of 12 weeks of whole body electrostimulation (WB-EMS) and~     dietetic treatment in patients with malignant disease on curative or palliative treatment~     situation on body composition, muscle strength and quality of life.~   "
58364|NCT02293226|"~     The investigators will compare the success rates and time to successful intubation of~     endotracheal intubation during simulated pediatric and infant resuscitation with and without~     chest compression using four different video-laryngoscopes.~   "
58365|NCT02293213|"~     Investigators propose a randomized controlled trial of women taking category D or X~     medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in~     the intervention group will receive an electronic medical record referral for teratogen~     counseling and contraceptive counseling with a follow up contraceptive provision~     appointment. The contraceptive counseling will be adapted from The Contraceptive CHOICE~     Project script and promote the use of the long acting reversible contraception. The women in~     the control group will also receive an electronic medical record referral and receive the~     teratogen counseling but only be told that it is important to avoid becoming pregnant. An~     initial survey will assess contraceptive knowledge and utilization. In addition, there will~     be telephone survey at 3 months and 6 months to assess contraceptive utilization and~     continuation.~   "
58366|NCT02293200|"~     The aim of the study was to compare two methods of training in CPR, standard basic life~     support and CPR using CPR feedback device.~   "
58367|NCT02293187|"~     This one-year study will test the hypothesis that supplementation with vitamin D will~     improve lower extremity muscle performance in older men and women with vitamin D~     insufficiency.~   "
58368|NCT02293174|"~     Establish a normal baseline setting configuration for image capture using the Topcon~     TRC-NW400 non-mydriatic retinal camera.~   "
58369|NCT02293161|"~     GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to~     the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being~     developed for the treatment of autoimmune indications. This study is intended to further~     explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and~     immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those~     already evaluated in I7R116702 (First Time In Human study). The study is anticipated to~     enrol 18 subjects in total, with 9 subjects in each of the two cohorts.~   "
58392|NCT02292862|"~     Maternal microchimerism has been discussed as an etiological mechanism in infantile~     (perinatal) biliary atresia (BA). In Kasai's operation (resection of the liver hilum plaque~     followed by hepato-portoenterostomy) surgeons frequently encounter swollen portal and~     mesenteric lymph nodes.~      Lymph nodes were sampled during Kasai' s operation and examined for maternal DNA.~   "
58393|NCT02292849|"~     The goal of this study is to test the feasibility, acceptability and preliminary impact of~     peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally~     Occurring Retirement Communities (NORC) residents or senior center participants.~   "
58370|NCT02293148|"~     This study is being performed to comply with regulatory requirements that all new~     non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization~     through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)'~     study. This will be a two part study, Part A will be an open-label, single oral dose study~     design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram~     (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled,~     single, oral dose, four-way crossover study design. Parts A and B will be conducted in~     healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety~     tests, vital sign measurements, physical examinations, adverse event reports, and~     pharmacokinetic samples collected throughout the study.~   "
58371|NCT02293135|"~     The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic~     patients referred on the diabetic consultations. The effects of one Stendo pulsating suit~     session system will be assessed on the peripheral cutaneous microcirculation and on~     endothelial functions~   "
58372|NCT02293122|"~     The purpose of this study is to evaluate the precision and agreement of the study device, a~     specular microscope, in comparison to a currently commercially available specular microscope~     in establishing substantial equivalence of the two devices in clinical use for diagnostic~     purposes of the human cornea.~   "
58373|NCT02293109|"~     This phase I trial studies the side effects and best dose of carfilzomib when given together~     with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin~     hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly~     diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     carfilzomib with combination chemotherapy may kill more cancer cells.~   "
58374|NCT02293096|"~     The investigators will prospectively follow a population of patients with uncontrolled high~     blood pressure beginning metoprolol succinate therapy to determine the drug effect in an~     observational clinical trial. The investigators will determine each individual's genotype~     for both CYP2D6 and Adrenoceptor Beta 1 (ADRB1). Metabolomic markers will be identified to~     determine if specific metabolites are associated with drug response. The investigators'~     overall objective is to determine if genetics predicts metoprolol succinate response better~     than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.~   "
58375|NCT02293083|"~     Myofascial pain syndrome (MPS) is the most common cause of persistent regional pain~     characterized by myofascial trigger points. Trigger point injection (TPI) using local~     anesthetics is one of the most effective methods for treatment of MPS, and steroids or~     botulinum toxin can be added to local injections .~      Recent study suggested that the hyaluronan (HA) could be the basis of myofascial pain. HA~     within the deep fascia facilitates the free sliding of two adjacent fibrous fascial layers.~     If the HA assumes a more packed conformation, or more generally, if the loose connective~     tissue inside the fascia alters its density, the behavior of the entire deep fascia and the~     underlying muscle would be compromised.~      The investigators anticipated that hyaluronidase could decrease the viscosity of HA near the~     muscle and fascia of trigger points. Meanwhile, hyaluronidase is thought to promote the~     spread of local anesthetic solution by hydrolyzing glycosidic bonds within HA. Hyaluronidase~     was shown to be effective in retro- and peribulbar block for ophthalmologic surgery or~     reducing tissue edema in dermatology, and adhesiolysis for some interventional pain~     managements.~      However, the effect of the addition of hyaluronidase to local anesthetics during TPI has not~     been studied. The investigators aimed to compare the efficacy of TPI with the addition of~     hyaluronidase compared to local anesthetic alone on pain and quality of life in MPS~     patients.~   "
58376|NCT02293070|"~     The objective of this study is to utilize delayed enhanced cardiac magnetic resonance~     imaging to assess the success of pulmonary vein isolation after cryoablation of paroxysmal~     atrial fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will~     be able to visualize changes in left atrial tissue characteristics caused by cryoablation~     used to treat paroxysmal atrial fibrillation.~   "
58377|NCT02293057|"~     Girls in the juvenile justice system have unique developmental pathways to drug use and~     co-occurring risk (e.g., HIV/STI) behaviors that have typically not been considered or~     tested in order to identify evidence-based gender-specific substance use treatment~     approaches for this population. This study will advance scientific knowledge and clinical~     practice in the drug treatment and public health fields by testing the efficacy of a~     pre-existing, widely disseminated gender-responsive substance use treatment (VOICES) on drug~     use and HIV/STI risk behavior outcomes for a broad range of substance using girls and young~     women (ages 12-24) who are at-risk for or already involved with the justice system.~   "
58378|NCT02293044|"~     This study will compare the safety and effectiveness of a potassium oxalate desensitizer on~     adjacent teeth with dentinal hypersensitivity.~   "
58379|NCT02293031|"~     The purpose of this study is to evaluate safety and efficacy of gene-activated matrix~     (Nucleostim) for regeneration of bone tissue in maxillofacial area. Patients with~     congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects~     after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar~     bone atrophy will be included into the study.~   "
58380|NCT02293018|"~     The purpose of this study is to determine the pharmacokinetic properties of topically~     applied MTC896 Gel following application of 0.75% (w/w) MTC896 Gel once daily and twice~     daily and 1.5% (w/w) once daily over 4 weeks in the treatment of acne.~   "
58394|NCT02292836|"~     The purpose of this study is to test and refine, a subject questionnaire aimed to be used in~     a general population rosacea prevalence study.~   "
58395|NCT02292823|"~     Prospective, non-randomized, single arm, multicenter observational study. The objective is~     to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo~     stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary~     intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world~     setting.~   "
58381|NCT02293005|"~     Objectives:~      Objectives~      The primary objective of this study is to:~      To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable~     malignant pleural mesothelioma (MPM) treated with alisertib~      The secondary objectives of this study are to:~      To assess the response rate (confirmed and unconfirmed complete + partial responses) To~     assess the progression-free survival. To assess overall survival. To evaluate the side~     effects and toxicities associated with this treatment regimen.~      To collect archival tissue, blood, pleural effusion fluid and plasma for correlative~     studies.~      Exploratory Objectives:~      To collect archival or new tissue, blood and pleural effusion fluid for correlative studies.~     Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene~     amplification.~      Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.~   "
58382|NCT02292992|"~     The difference of lung volume change will be monitored by electrical impedance tomography~     before and after use of noninvasive positive pressure ventilation by nasal pillow and high~     flow nasal cannula in post-extubation patients.~   "
58383|NCT02292979|"~     This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination~     (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with~     an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography )~     after two cycles of chemotherapy.~   "
58384|NCT02292966|"~     The purpose of this study is to examine whether neurocognitive impairments experienced by~     patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV,~     with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir~     (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous~     system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and~     comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.~   "
58385|NCT02292953|"~     The purpose of the study is to determine whether or not stressful conditions such as ovum~     pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin~     (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm~     injection (ICSI) & possible effect on implantation & pregnancy rate.~   "
58386|NCT02292940|"~     Patient use of health IT tools to interact with healthcare providers and delivery systems,~     including exchanging secure messages with their medical providers and using other web-based~     tools, has great potential to increase patient access to care, change the way healthcare is~     delivered, and affect patient clinical outcomes. This study will examine the impact of~     implementation and use of consumer health IT tools on patient-reported access to care,~     utilization of medical care services, and clinical outcomes.~   "
58387|NCT02292927|"~     DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the~     acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation~     program in a cohort of patients undergoing aneurysm repair.~      This will enable the design (feasibility and power) of a large scale Randomised Controlled~     Trial.~      Expected outcomes~        -  The potential number of patients who would benefit, the compliance and acceptability of~          a pre-operative prehabilitation programme will be calculated.~        -  Preoperatively, expected at 6-weeks, the change in physical fitness of patients~          (assessed by the physical function section of SF-36 and measured with peak~          flow/6-minute walk testing) during the pre-operative phase will be assessed in both~          groups.~        -  The effects on quality of life, anxiety and depression on each study participant will~          be assessed immediately pre-op, expected at 6-weeks.~        -  The number of patients who are able to reduce or cease smoking will be reported during~          the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic~          surgery, expected at 6-8 weeks.~      POPULATION: Patients undergoing planned elective aortic surgery procedures~      ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular~     aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative~     exercise programme DURATION: 1 year from 1st June 2014~   "
58388|NCT02292914|"~     The robot-assisted surgery allows three-dimensional view, detailed access of small~     structures, depth perception and articulated movements with wide latitude. Thinking about~     the inclusion of this branch of surgical outcome ICESP encouraged the training of their~     doctors and other health professionals , and has three tutors in the area of robot- assisted~     laparoscopic surgery , and various medical clinical staff , already trained , and already~     perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in~     the World market) , consisting of one or two consoles for the surgeon and a tutor if~     necessary was adopted. Ergonomically designed, a stand next to the patient , with four~     interactive robotic arms , one of them , a vision system for high performance and the other~     three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology ,~     computer programs , frictionless transmission of manual controls , movements in scale and~     filtered made by the surgeon in the da Vinci ® System console are translated into precise~     movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers~     superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For~     hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of~     minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main~     objective is to evaluate the safety and effectiveness of robotic surgery in the surgical~     treatment of cancer in operations below, as their specialties : Digestive , Urology ,~     Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months ,~     where 1120 patients with surgical diseases in programming for the following operations will~     be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ;~     partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial~     nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection~     of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will~     come from the outpatient services of the Institute of Cancer of São Paulo - ICESP~   "
58389|NCT02292901|"~     Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac~     videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of~     difficult of mask ventilation and of tracheal intubation.~   "
58390|NCT02292888|"~     Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is~     to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the~     product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ).~      The LVOT diameter for an individual is more or less a constant measurement. Therefore using~     the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then~     SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to~     achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this~     assumption is true, then an increase in the value of VTI from baseline after fluid challenge~     (10-15%), should identify a volume responsive patient.~   "
62603|NCT02237898|"~     Through a smartphone platform, financial incentives for smoking abstinence in postpartum~     women can be delivered remotely, thus minimizing the need for participants to come to the~     office to receive traditional contingency management.~   "
58396|NCT02292810|"~     Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The~     exercise of inspiratory muscles has been investigating in various clinical situations and~     may cause similar benefits as the conventional exercises. The assessment of glucose~     variability has been used as an alternative tool to evaluate the others mechanisms than the~     absolute values of glucose levels, special during the exercise. However, the effect of~     inspiratory muscle exercise on glucose levels and glucose variability is not clear yet. The~     aim of the proposed research is to evaluate the acute effects of inspiratory muscle exercise~     using a high load of 60% of MIP on glucose levels and glucose variability in patients with~     type 2 diabetes.~   "
58397|NCT02292797|"~     Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea~     Prevalence in the General Population.~   "
58398|NCT02292784|"~     The primary objective of this study is to assess the safety and outcomes of infants and~     children who were exposed to retosiban or comparator in utero in the planned Phase III~     spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is~     not associated with significant adverse outcomes in early childhood. The enrolled infants~     and children will be followed at pre-specified intervals until they reach 5 years~     chronological age. This study does not require medical interventions or study visits to an~     investigational site, instead, parents or legal guardians will be prompted at certain time~     points to complete developmental questionnaires and other data on their children's health~     status via an electronic device. Data collected during the infant and child follow up study~     will be managed by a centralized research coordinating center (RCC). Regionally based~     pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this~     study. All communications the RCC-PI has with the parent/legal guardian or the child's~     health care provider (HCP) will occur remotely; there will be no clinic visits.~   "
58399|NCT02292771|"~     The primary objective of this study is to demonstrate the superiority of retosiban to~     prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This~     objective is based on the hypothesis that prolonging the time to delivery in the absence of~     harm may benefit the newborn, particularly in women who experience spontaneous preterm labor~     at early gestational ages (GA). This study is designed to test this hypothesis through a~     direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for~     short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks'~     gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which~     consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment,~     Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330~     females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The~     duration of any one subject's (maternal or neonatal) participation in the study will be~     variable and dependent on GA at study entry and the date of delivery.~   "
58400|NCT02292758|"~     This randomized phase II trial studies how well irinotecan and cetuximab with or without~     bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread~     to other places in the body and cannot be removed by surgery. Irinotecan may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as cetuximab and bevacizumab, may interfere with the ability of tumor cells~     to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work~     betting in treating patients with colorectal cancer.~   "
58401|NCT02292745|"~     The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and~     stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an~     increase in survival.~   "
58402|NCT02292732|"~     This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to~     evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose~     pharmacokinetic (PK) of an oral contraceptive (OC) containing norethindrone (NE) and ethinyl~     estradiol (EE) (ORTHO-NOVUM® tablets: 1 mg NE + 0.035 mg EE) in female subjects with solid~     tumors.~      The study will determine PK interaction between trametinib and the components of combination~     oral contraceptives that would compromise the effectiveness of the contraceptives.~      The study will also evaluate the repeat dose PK of trametinib and its metabolite M5 using a~     validated assay.~      The study will enroll approximately 24 subjects. Each subject will participate in the study~     for approximately up to 13 to 15 weeks which will consist of a 30 day screening period,~     followed by 2 treatment periods (Period 1: 28 days and Period 2: ranging from 12 days to up~     to 21 days), and a transition visit or post-treatment follow-up visit. In Period 1, subjects~     will take one active tablet from the ORTHO-NOVUM® tablet 1/35 dial-pack once daily at~     approximately the same time each day for 21 days (Days 1 through 21), followed by one inert~     (referred to as placebo) tablet once daily at approximately the same time each day for 7~     days (Days 22 through 28). In addition, subjects will take trametinib 2 mg (1 tablet) once~     daily at approximately the same time each day for a total of 17 days (Days 12 through 28).~     In Period 2, subjects will take one active tablet from the ORTHO-NOVUM® tablet 1/35~     dial-pack once daily at approximately the same time each day for 11 days (Days 1 through~     11). In addition, subjects will continue taking trametinib 2 mg (1 tablet) once daily at~     approximately the same time each day for 11 days (Days 1 through 11). ORTHO-NOVUM® is a~     registered trademark of Ortho Pharmaceutical Corporation.~   "
58403|NCT02292719|"~     The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r~     with sofosbuvir with or without ribavirin in adults with Genotype 2 Chronic Hepatitis C~     Virus (HCV)infection or Genotype 3 HCV infection With or Without Cirrhosis.~   "
58404|NCT02292706|"~     This Registry will enroll cirrhotic participants with or without decompensated liver disease~     who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir~     (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored~     hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants~     will be followed for up to 5 years.~   "
58405|NCT02292693|"~     The aim of this study was to compare time, success rates of different laryngoscope blades~     for intubation with an immobilized cervical spine in a standardized pediatric manikin model.~   "
58406|NCT02292680|"~     This study aims to identify early life exposures to metals and chemicals by measuring the~     concentration of metals and organic compounds in shed primary teeth. The researchers will~     also investigate associations between the presence of these chemicals in teeth and~     children's social, emotional, and neuro-development.~   "
58407|NCT02292667|"~     The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus~     abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the~     postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP~     study is a single-center open-label randomized controlled trial. Half of patients included~     will receive the association of TAP block and multimodal intravenous analgesia, and the~     other half will receive the multimodal intravenous analgesia alone. The multimodal~     intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled~     analgesia with morphine.~   "
58409|NCT02292641|"~     In the UK approximately 28,000 patients per year are diagnosed with bowel cancer. Further~     15-20% develop pelvic recurrence. In a significant proportion of patients (15-20%), tumour~     extends beyond what the surgeon can routinely remove and requires more extensive~     (exenterative) surgery to achieve successful removal of the tumour. Currently MRI is used~     for the assessment of the pelvic tumour and PET/CT is used in order to prove that there is~     no extrapelvic disease, for the selection of patients who will undergo such a complex~     surgery. The investigators have previously shown, with a single centre retrospective~     analysis, that using a specific staging system for these tumours it is possible to predict~     both the likelihood of surgical success and overall survival outcomes. Until today there are~     no national guidelines for this group of patients.~      The investigators want to test whether standardizing the assessment of these advanced~     tumours will help to improve outcomes for patients and better surgical planning. The~     investigators also want to show that the information from the scans gives valuable data~     regarding the long term outcomes and likelihood of surgical success.~      This is a multicentre prospective trial of patients, who require more extensive surgery,~     using the staging classification. The high resolution MRI scans that patients undergo before~     surgery will be reported using the previously validated system.~      It is hoped that the study will result in a better and standarised method of assessing~     advanced pelvic cancer, with the intent to improve the surgical planning and overall patient~     management, which may increase the possibility of surgical curative resection.~   "
58410|NCT02292628|"~     This is a clinical trial phase I/II, double blind, randomized to compare in two groups of~     patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from~     the adipose tissue (CMMAd) in the treatment of the faecal incontinence.~   "
58411|NCT02292615|"~     In this prospective cohort study, patients with newly diagnosed gynecologic cancers~     (including cervical, endometrial, and ovarian cancers) and patients with suspicious~     recurrent gynecologic cancers will be enrolled. The study period is two years and the~     estimated patient number is about 220. Patients will undergo image study before and after~     treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image~     biomarkers to monitor treatment response and predict treatment outcome will be investigated.~   "
58412|NCT02292602|"~     The purpose of this study is to examine the feasibility, acceptability, and preliminary~     efficacy of a community and home-based preschool obesity intervention for families enrolled~     in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).~   "
58413|NCT02292589|"~     The purpose of this study is to determine the early effects of transcranial direct current~     stimulation (tDCS) in patients with mild traumatic brain injury and persistent post~     concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive~     function(inhibitory control).~   "
58414|NCT02292576|"~     Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols~     cocoa~   "
58415|NCT02292563|"~     The purpose of this study is to determine whether experienced endoscopy nurse participation~     during screening colonoscopy could increase polyp and adenoma detection rate.~   "
58416|NCT02292550|"~     This is a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6~     inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.~      The purpose of the study is to determine the MTD/RP2D of the LEE011 and ceritinib~     combination and evaluate whether the combination is safe and has beneficial effects in~     ALK-positive advanced non-small cell lung cancer patients.~   "
58417|NCT02292537|"~     This study will test the Clinical Efficacy and Safety of IONIS-SMN Rx in patients with~     later-onset Spinal Muscular Atrophy.~   "
58418|NCT02292524|"~     Prostate Biomarkers in Men Consuming Tomato Products~   "
58419|NCT02292511|"~     The purpose of this study is to determine if a 6 month mind-motor intervention will help to~     improve overall brain health in adults over the age of 55 with type 2 diabetes and a~     self-reported complaint about memory or thinking skills. It is hypothesized that the~     intervention group will show improvements in their overall brain health after 6 months of~     mind-motor training compared to the control group.~   "
58420|NCT02292498|"~     The purpose of this study is to see if thermal images can be used to diagnose bacterial~     pneumonia instead of a chest x-ray. More specifically, the objectives of this study are: 1)~     to determine if thermal imaging, using a commercial thermal camera can accurately detect the~     presence of bacterial pneumonia in patients receiving a chest x-ray to rule out pneumonia;~     2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia~     in patients receiving chest x-rays for this purpose.~   "
58421|NCT02292485|"~     Investigators will administer a brief, anonymous survey at the Texas Academy of Family~     Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary~     care physicians in Texas to implement lung cancer screening programs in their practice~     settings.~   "
58422|NCT02292472|"~     This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding~     Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric~     Hypertrophy.~   "
58423|NCT02292459|"~     The purpose of this study is to evaluate the complete resolution of constipation in~     participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the~     number of bowel movements from self-reported bowel movement (BM) data. The complete~     resolution of constipation is defined as the elimination of straining or of hard/lumpy~     stools.~   "
58424|NCT02292446|"~     The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP)~     is to provide early access to ruxolitinib and evaluate safety information in patients with~     PV, who are HU resistant or intolerant and who have no other standard treatment option, nor~     do they qualify for another clinical study for PV.~   "
58425|NCT02292433|"~     Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics~     of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As~     Monotherapy~   "
58426|NCT02292420|"~     The purpose of this study is to determine the normal reference values of pulse oximetry~     plethymographic waveform parameters in Chinese population.~   "
58427|NCT02292407|"~     This study aims at providing first evidence that axillary clearance by using an operation~     technique including the precise LigaSure instrument and closure of dead space of the axilla~     will result in an operation were a drain is not necessary and the need for seroma evacuation~     after surgery is very limited.~   "
58428|NCT02292394|"~     Caring for dependent persons can give rise to depression in non-professional caregivers,~     placing a burden on health care services and threatening the quality of the care dispensed~     to the dependent. Unfortunately, the ability of these patients to attend therapy sessions is~     often limited precisely by their role as caregivers. Preventive measures that are accessible~     to caregivers are thus called for. The primary aim of this project is to evaluate the~     efficacy of telephonic administration of a brief indicated preventive psychological~     intervention for depression that in previous work proved effective when administered in~     person in group sessions. With a view to optimizing resource usage by maximizing~     interventional efficacy, the secondary aim is to determine the contribution to overall~     efficacy of that part of the intervention that consists in increasing pleasant activities.~     To these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for~     inclusion in the study will be randomized to one of three interventions (≈ 60 participants~     per intervention): the full cognitive-behavioural programme; a program focused only on the~     component of pleasant activities; or a usual care condition. Both programmes will be~     administered in five 90 minute sessions by audio tele-conference. All sessions will be~     recorded for verification of adherence to the intervention protocols. Participants will be~     re-evaluated at the end of their intervention (when participant satisfaction with the~     cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months~     later; all evaluations will be performed by trained interviewers who will be blind to the~     aims of the study, the interventions employed, and the group to which any given participant~     belongs. Analyses of these evaluations will compare the short- and long-term efficacies of~     the three groups. Factors that mediate participant improvement or predict results will also~     be investigated, and the cost-effectiveness of the interventions will be estimated.The~     central hypothesis of the proposed study is that a multicomponent cognitive-behavioral~     telephone intervention and a protocol assessing participation in pleasant activities will~     both significantly reduce the incidence of depression and depressive symptoms compared to a~     control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month~     follow-up visits.~   "
58429|NCT02292381|"~     Glaucoma is one of the leading causes for blindness in industrialized countries. It is~     characterized by a progressive loss of retinal ganglion cells, morphological changes in the~     optic nerve head and a characteristic loss of visual field. Although increased intraocular~     pressure has been identified as the major risk factor for the development and the~     progression of the disease it has been speculated for a long time that impaired ocular blood~     flow may contribute to the pathogenesis of the disease. This concept has been supported by~     several epidemiological studies showing that low ocular perfusion pressure and small retinal~     vessel caliber are associated with the disease.~      The proposed study tests the hypothesis that patients with glaucoma have reduced total~     retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood~     flow will be investigated during an increase in ocular perfusion pressure. This is of~     importance because it may clarify the degree of vascular involvement in glaucoma.~   "
58430|NCT02292368|"~     The goal of this clinical research study is to learn which areas of the brain respond to~     acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and~     neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and~     improve patient quality of life.~   "
58431|NCT02292355|"~     Introduction: the influence of temporomandibular disorders (TMD) related to postural changes~     are yet no consensus, but it is believed that the imbalances of a system can influence~     another. Several techniques have been used to treat TMD and its associated problems, however~     there is a paucity of studies evaluating the effects of global treatments, such as Pilates,~     in individuals with TMD literature. Objective: To evaluate changes in the level of pain, the~     severity of TMD, the EMG activity of masticatory muscles and posture of young women~     undergoing training in Pilates, as well as correlating postural changes, pain level,~     severity of TMD and EMG activity of masticatory muscles. A randomized clinical trial with~     blinded assessors will be held. 40 patients divided randomly into two groups will be~     assessed, the control group (CG) who receive conventional treatment with occlusal splint and~     intervention group (IG), which in addition to conventional treatment will undergo Pilates~     sessions. Both groups will be formed for women aged 18 to 35 years with TMD and pain. The IG~     will receive treatment with the Pilates Method for 15 weeks with frequency of twice weekly~     and use occlusal splint as directed by the dentist. The CG will make use of occlusal splint~     alone. At the beginning and end of the 15 weeks the individuals are evaluated to verify the~     presence of TMD, TMD severity, pain, EMG evaluation of masticatory muscles and body posture.~     Data will be analyzed statistically.~   "
58432|NCT02292342|"~     Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level~     doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.~   "
58433|NCT02292329|"~     The purpose of this study is to carry out a randomized double blind controlled trial in 30~     male subjects to investigate the effect of acai consumption on acute changes in vascular~     function, and to other cardiovascular markers. As a secondary aim the study will allow us to~     characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour~     period.~   "
58434|NCT02292316|"~     The purpose of this study is to determine whether cognitive disorders are a risk factor for~     a fracture after a fall independently of a bone fragility.~   "
58435|NCT02292303|"~     The main objective of this clinical is to get information on pharmacokinetics of~     zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to~     two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.~   "
58436|NCT02292290|"~     Dual therapy with metformin and Liraglutide is more effective at helping people with~     established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite~     endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no~     severe hypoglycaemic events.~   "
58437|NCT02292277|"~     Patients with myocardial infarction, which does not include all layers of the heart's muscle~     wall are common and they often receive pharmacological treatment with the platelet~     inhibiting drug ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor~     has not been thoroughly studied in these patients.~      The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg~     loading dose ticagrelor in these patients.~   "
58438|NCT02292264|"~     The aim of this study is to evaluate risk factors and complications of ventral hernia~     repair. A retrospective study of journal files with patients undergoing ventral hernia~     repair, and an analyses of complications by use of the Clavien-Dindo classification of~     surgical complications.~   "
58439|NCT02292251|"~     Stroke often results in limitation of arm movements, from which many people do not fully~     recover. We believe that early and intensive therapy is important to enhance recovery of arm~     movements after stroke. We are doing this research study to see how much arm movements~     improve with intensive therapy in patients have had a stroke in the past 6 weeks.~   "
58734|NCT02288377|"~     This European, prospective, multicentre, double-blind randomised study will evaluate the~     effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in~     patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine~     tumours.~   "
58440|NCT02292238|"~     General Investigational Plan~      Study Objectives The goal of this proposal is to determine whether enhancing brain glucose~     utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment~     (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept~     double-blind, placebo controlled pilot study to determine if increasing brain thiamine~     availability with the investigational new drug benfotiamine, will minimize the decline in~     glucose utilization and slow the cognitive decline associated with the progression AMCI/AD~     dementia.~      Specifically, our objectives are two-fold:~        -  To test whether increasing brain thiamine by administering 600 mg per day (300~          mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline~          in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~        -  To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning~          and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain~          glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron~          Emission Tomography(FGPET) in the posterior cingulate.~      We will also carry out the following secondary objectives:~        -  Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL,~          CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive~          domains (ie: activities of daily living, learning and memory verbal memory, behavioral,~          etc.) are driving these changes.~        -  Compare ADAS-COG change scores in the benfotiamine and placebo groups within and~          between strata that were defined by initial cognitive impairment, to attempt to~          identified the population that most benefits from benfotiamine.~        -  Compare changes in glucose utilization between the benfotiamine and placebo groups in~          secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and~          entorhinal cortex.~        -  Compare changes in whole brain glucose utilization between the benfotiamine and placebo~          groups using statistical parametric mapping (SPM).~        -  Assess the correlation between changes in glucose utilization with changes in ADAS Cog.~        -  Determine if ApoE4 genotype alters the response to benfotiamine.~   "
58441|NCT02292225|"~     To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in~     combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small~     Lymphocytic Lymphoma previously treated with a BTKi.~   "
58442|NCT02292212|"~     The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21)~     .~   "
58443|NCT02292199|"~     Hypertension has high prevalence and poor control rates and is considered one of the major~     modifiable risk factors for cardiovascular system diseases, and one of the most important~     public health problems. The imbalance of the autonomic cardiovascular control, which can be~     considered as a major etiologic factor in the development of essential hypertension is~     characterized by increased sympathetic activity and reduced parasympathetic activity~     possible.~      Cardiovascular disease is the leading cause of death and disability in the world and~     autonomic imbalance is associated with several pathological conditions, and may be a final~     common pathway for the increased morbidity and mortality of cardiovascular diseases. In this~     sense, the heart rate variability (HRV) is a quantitative marker of sympathetic and~     parasympathetic activity, which can be used to assess disease and mortality as a noninvasive~     technique.~      TENS is a noninvasive therapeutic modality, easy to handle, it has no side effects or~     interactions with medications being used for the relief of pain by sensory stimulation~     through peripheral nerves and mainly for control and treatment of acute and chronic pain .~     Research on the effect of TENS on the sympathetic and parasympathetic nervous system~     activity remain controversial, especially regarding the parameters to use.~      The aim of this study is to investigate the effects of TENS on the sympathetic and~     parasympathetic nervous system in patients with hypertension by heart rate variability and~     blood pressure variability.~      This is a randomized clinical trial, double blind, where hypertensive patients were~     randomized to three groups: high-frequency TENS (100 Hz) n = 20, low frequency TENS (4 Hz) n~     = 20 and n = 20 placebo. Evaluations will be made in a single session. The results will be~     assessed by a blinded investigator and randomization will be done electronically.~      It is expected to evaluate how often TENS exerts more influence in the modulation of~     sympathetic and parasympathetic system.~   "
58444|NCT02292186|"~     The purpose of this study was to evaluate the safety and clinical activity of long-term~     dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being~     followed-up for safety.~   "
58445|NCT02292173|"~     The main purpose of this study is to see whether the combination of trametinib and sorafenib~     can help people with hepatocellular cancer. Researchers also want to find out if the~     combination of trametinib and sorafenib is safe and tolerable.~   "
58446|NCT02292160|"~     The objective is to determine if data from the National Insurance Health card (giving~     antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk~     of antibiotic resistance and to identify population groups for which probabilistic~     antibiotics regimen of urinary tract infection could be simplified~   "
58447|NCT02292147|"~     Descriptive and prognosis study of the functional outcome after cardiac arrest for the~     patients awake within the first 15 days.~   "
58448|NCT02292134|"~     Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors~     involved in poor sleep quality are environmental factors, such as light and noise, which are~     an unavoidable consequence of cares.~      The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep~     architecture and quality in ICU patients.~   "
58449|NCT02292121|"~     In rodents, obesity is associated with changes in tight junctions' structure in small~     intestine, which impacts intestinal permeability and results in metabolic complications. Few~     data exist in human. We hypothesized that intestinal permeability is altered in obese~     subjects in comparison to lean subjects, linked to metabolic and inflammatory status and~     that these alterations are modified after gastric bypass.~   "
58450|NCT02292108|"~     High food impulsiveness, impaired food reward and stress response are involved in the~     phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a~     complementary medicine which is recognized as effective for defined indications. Complexity~     and diversity of methodological studies with hypnosis does not allow to conclude on its~     efficacy in treating this disease.~      In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and~     self-hypnosis practice would improve food disinhibition assessed by an adapted questionary~     (TFEQ 51).~   "
58451|NCT02292095|"~     The incidence of post-operative pain after open inguinal hernia repair is high and impair~     the quality of lives of the patients.The purpose of this study is to determine whether~     transverse abdominis plane block combined with intravenous patient controlled analgesia is~     superior to intravenous patient controlled analgesia in improving the quality of life and~     reducing the incidence of chronic post-surgical pain~   "
58452|NCT02292082|"~     Total knee replacement is associated with severe post-operative pain. The purpose of this~     study is to compare two methods of treatment for pain control following Total Knee~     Replacement with an accelerated physical therapy protocol to aid the achievement of rehab~     milestones.~   "
58453|NCT02292069|"~     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium~     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine~     besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals~     Dublin, Ireland in healthy, adult,human subjects under Fed conditions.~   "
58506|NCT02291380|"~     A study, multi-center, randomized, double-blind, placebo parallel-controlled method, will be~     carried out to evaluate the safety and efficacy of Botulinum Toxin Type A for injection~     (HengLi®) for prophylactic treatment with chronic migraine in adults. In the core phase, two~     treatments of HengLi® or the placebo will be administrated (randomized at a ratio of 2:1,~     the target number is 288 subjects). In the extension phase, three treatments of HengLi® will~     be still administrated on 288 subjects recruited ever.~   "
58454|NCT02292056|"~     There is currently limited research that addresses the unique medication safety and family~     planning needs among women of reproductive age with psychiatric conditions. The study will~     research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford~     Clinic in the Department of Psychiatry at UCSD that will help women in this population~     better understand: 1) which of their medications are safe to use in pregnancy, 2) provide~     education regarding the importance of using contraception and which contraceptive choices~     are available to them, and 3) raise awareness of any drug-drug interactions that may exist~     between their medications and their chosen method of contraception. Patients will be given~     questionnaire to assess their contraceptive utilization. They will also be given a before~     and after quiz to allow for an objective measure of the patient's increase in knowledge~     regarding medication safety and contraceptive choices as a result of the investigators~     intervention.~   "
58455|NCT02292043|"~     The investigators would evaluate the effects of the novel method, HTEA on cardiac function~     in the heart failure patients secondary to idiopathic dilated cardiomyopathy and~     post-myocardial infarction.~   "
58456|NCT02292030|"~     The purpose of this study is to explore the efficacy of low energy cardioversion on atrial~     fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.~   "
58457|NCT02292017|"~     This is a prospective single center trial investigating the effects of prospectively~     measuring packing density prior to choosing Target Coils for the treatment of intracranial~     saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial~     saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation,~     will be treated with Stryker Target Detachable Coils.~      Historical data from patients enrolled in the MAPS trial at the single center will be the~     control arm of the trial and reviewed for comparison to the prospective arm. In the control~     arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils~     and packing density was not measured prior to these procedures. The Pro-Pack Trial will~     evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density~     will be actively calculated prior to coil selection. This will serve to establish that a~     higher packing density can be obtained by the change in methodology of coil selection and a~     higher packing density with lower recurrence rates.~   "
58458|NCT02292004|"~     This study will assess the safety and early efficacy of a newly developed device,~     bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.)~     Ten participants will undergo surgery with the new device (Experimental Group) and 10 will~     undergo a standard ACL reconstruction surgery (Control Group.)~   "
58459|NCT02291991|"~     This is a randomized, placebo controlled, single dose study to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.~   "
58460|NCT02291978|"~     The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity~     focused ultrasound device as an intervention for treatment of facetogenic lower back pain.~   "
58461|NCT02291965|"~     Specific Aim 1: To determine whether endogenous metabolomics-based biomarkers obtained~     before IV BU administration can predict IV BU clearance.~      Specific Aim 2: To characterize IV BU metabolism by metabolomics.~      Specific Aim 3: To identify covariates influencing IV BU pharmacokinetics.~   "
58462|NCT02291952|"~     The goal of this application is to determine whether changing the timing of food intake~     prevents the adverse metabolic effects of circadian misalignment.~   "
58463|NCT02291939|"~     The objective of the clinical trial is to determine the suitability of the FMwand~     Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.~   "
58464|NCT02291926|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.~   "
58465|NCT02291913|"~     Many patients with ER-positive or PR-positive breast cancer usually are treated with~     endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal~     therapy, patients often experience disease progression. Everolimus, in combination with~     exemestane, has shown activity in endocrine-resistant disease. This study will evaluate the~     efficacy of Everolimus+ anti-estrogen therapy in patients with ER-positive metastatic breast~     cancer who have progressed after receiving anti-estrogen therapy.~   "
58466|NCT02291900|"~     The purpose of this study is to determine if surgical angiogenesis performed in talar~     avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior~     technique compared to core decompression and nonvascularized osseous autografts.~   "
58467|NCT02291887|"~     A cohort of patients responsive to treatment with ranibizumab but resistant to~      aflibercept were identified in a previously conducted retrospective study. Identified~      patients will have their blood drawn for genome wide sequencing. The sequencing~      data will be compiled and analyzed in an attempt to identify a common genetic basis~      for patients susceptible to ranibizumab but resistant to aflibercept.~   "
58468|NCT02291874|"~     Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of~     Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2~     Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.~   "
58469|NCT02291861|"~     The purpose of this study is to determine whether fixed-doses of an investigational drug,~     SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of~     tardive dyskinesia.~   "
58470|NCT02291848|"~     This study is for patients that have a cancer called Multiple Myeloma. This research study~     uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T~     lymphocytes (CTLs), a new experimental therapy.~      The proteins that investigators are targeting in this study are called tumor associated~     antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do~     not show or show up in low quantities on normal human cells. In this study we target five~     common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol,~     patients have been treated and so far this treatment has shown to be safe.~      Investigators now want to try this treatment in patients with multiple myeloma.~      These TAA-specific CTLs are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn~     what the side effects are, and to see whether this therapy might help patients with multiple~     myeloma.~   "
58471|NCT02291835|"~     Periodontitis is a chronic inflammatory disease and a significant risk factor for tooth~     loss. While a link between diet and periodontal health exists, the relationship between diet~     and healing following periodontal therapy has yet to be investigated.The objective of this~     study was to determine if higher intakes of foods and nutrients with antioxidant or~     anti-inflammatory activity are associated with reduced probing depth following sanative~     therapy. Sanative therapy is a first line cost-effective treatment to manage periodontal~     disease and thus prevent tooth loss. Patients with chronic generalized periodontitis~     undergoing sanative therapy were recruited for the study. Mean probing depth was assessed at~     baseline and 8-16 weeks following sanative therapy. Dietary intakes of fruits, vegetables,~     vitamins and dietary fats were estimated using the Block 2005 food frequency questionnaire~     and supplement use was recorded using a questionnaire. A small venous blood sample was also~     collected at baseline to measure serum 25-hydroxyvitamin D concentrations.~   "
58472|NCT02291822|"~     Collection of already existing data and images for patients < 2 years of age having~     MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during~     a prospectively designed blinded reading of the images.~   "
58473|NCT02291809|"~     The primary objective is to compare & evaluate between the treatment groups the changes in~     decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the~     adult Remune dose vs the low dose Remune placebo groups. Additional objectives include~     changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.~   "
58474|NCT02291796|"~     Introduction: Plasma fibrinogen levels have been identified as an important risk factor for~     cardiovascular diseases and could have a prognostic value. Bezafibrate decreases fibrinogen~     levels and also the incidence of major cardiovascular events in primary prevention, but its~     effects in acute coronary syndrome is unknown.~      Hypothesis: Bezafibrate effect over statin therapy reduces fibrinogen concentrations,~     inflammatory response and clinical events, in patients with ST segment elevation ACS and~     hyperfibrinogenemia.~      Methods: In a randomized clinical trial, controlled with conventional therapy. Patients with~     ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500~     mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day (group I n=50)~     or just conventional therapy (group II n=50). Serum fibrinogen, c reactive protein and~     cytokines were measured. Clinical end points were recurrence of angina or infarction, left~     ventricular failure, cardiovascular mortality and combined end points during~     hospitalization.~   "
58475|NCT02291783|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor~     agonist intended for the treatment of cognitive disorders.~   "
58476|NCT02291770|"~     Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of~     second line immunosuppressive agents have been investigated but no optimal treatment has~     emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells~     (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate~     of 70% in steroid- refractory patients. In the present randomized study the efficacy and~     safety of MSC treatment will be further studied in patients with cGvHD.~   "
58477|NCT02291757|"~     Objectives:~      Primary: To evaluate the efficacy of NEM® versus placebo in improving joint pain and~     stiffness in subjects with knee osteoarthritis. Western Ontario and MacMaster Universities~     Osteoarthiritis Index (WOMAC)), Likert Scale, Range of Motion (ROM) evaluation and Visual~     Analogue Scale (VAS Scale) will be used as joint pain and stiffness scales for efficacy.~      Secondary: To evaluate the safety and tolerability of NEM® treatment.~   "
58478|NCT02291744|"~     The primary endpoint is to evaluate the TFS (time to failure of strategy).~   "
58479|NCT02291731|"~     To evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye~     drops and a silicone-hydrogel contact lens (CLs) in the treatment of recalcitrant persistent~     epithelial defects (PEDs) and the recurrence rate of epithelial breakdown with or without~     continued use of autologous serum eye drops.~   "
58480|NCT02291718|"~     The purpose of this study is to compare the contrast agents and imaging techniques used for~     thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed~     and adjusted based on the contrast agent, since contrast agents have varying iodine~     concentrations. If the contrast iodine concentration is higher, it may be possible to adjust~     the imaging parameters and lower the overall radiation dose to the patient.~   "
58481|NCT02291705|"~     Inguinal hernia repair is one of the common day-case surgery in children. The aim of this~     study is to compare the effects of ultrasound guided rectus sheath block and intravenous~     tramadol on peroperative anesthetic requirement and postoperative analgesia.~   "
58482|NCT02291692|"~     The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral~     block with bupivacaine on both perioperative anesthetic agent consumption and postoperative~     analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.~   "
58483|NCT02291679|"~     The objective of this trial is to determine the efficacy and safety of linaclotide~     administered to patients with chronic idiopathic constipation (CIC). The primary efficacy~     parameter is the percentage of patients in each dosing group that meet the protocol~     definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.~   "
58503|NCT02291419|"~     The purpose of this pilot study is to establish the rate of cardiovascular events in~     patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the~     efficacy and safety of FDA approved study drug (ticagrelor) compared to aspirin in these~     patients.~      Data from current studies suggest that myocardial injury detected by minor elevations in~     troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and~     is associated with an increased risk of mortality at 30 days and 1 year. There are no~     current guidelines for care of patients with elevated troponin levels in the absence of~     acute coronary syndrome. This study will assess if the increased risk of these patients is~     modifiable by an anti-platelet medication and evaluate the safety of this medication.~      Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet~     medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months,~     with the last contact at one month post treatment discontinuation.~   "
58484|NCT02291666|"~     Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and~     cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive~     characterization of the effects of T2D on the expression and activity of major CYP450s. In~     our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia~     are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and~     macro-vascular complications and inadequately controlled T2D due to high intersubject~     variability in drug disposition and action.~      Characterization of the effects of T2D on drug metabolism capacity will be performed using a~     cocktail of CYP450 probe drugs.~      CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D~     patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3)~     42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450~     probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2),~     bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),~     midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1).~     Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated~     and compared between three groups of subjects. Other co-variables to be studied include T2D~     biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and~     inflammatory markers.~      Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the~     activity of major CYP450s. Moreover, this project will indicate to us whether glycemic~     control should be considered as a covariate of intersubject variability in drug metabolism~     capacity.~   "
58485|NCT02291653|"~     We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins~     while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS~     and MIL laryngoscopes in child resuscitation with and without CC.~   "
58486|NCT02291640|"~     The aim of this study was to compare time, success rates of video laryngoscope and direct~     laryngoscope for the emergency intubation with an immobilized cervical spine in a~     standardized pediatric manikin model.~   "
58487|NCT02291627|"~     The aim of this study was to compare time, success rates of different video laryngoscopes~     for the emergency intubation with an immobilized cervical spine in a standardized pediatric~     manikin model.~   "
58488|NCT02291614|"~     The purpose of this Phase 1 study is to determine if AMG 211 given as a continous IV~     infusion is safe and tolerable in adult subjects that have advanced gastrointestinal~     adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of~     AMG 211. The safety of subjects will be monitored by intensive assessment of vital signs,~     electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed~     by the usual imaging procedures and their interpretation.~   "
58489|NCT02291601|"~     Demonstrate the reduction of bacteria on the skin.~   "
58490|NCT02291588|"~     This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811~     single subcutaneous and intravenous dose to subjects with SLE~   "
58491|NCT02291575|"~     The rural healthcare market in much of the developing world is composed largely of informal~     private providers. These private providers often have little to no certifiable medical~     training. Recent studies in India using medical vignettes (or hypothetical medical~     situations) to measure clinical competence and direct observations of doctor-patient~     interactions to measure clinical practice highlight the poor quality of care that most~     patients receive—a problem that is clearly relevant beyond India and affects most low-income~     countries worldwide. For instance:~        1. In rural India, standardized patients presenting with chest pain and (on further~          questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in~          less than 25 percent of cases.~        2. Across 8 low and middle-income countries, health care providers completed the four~          necessary vital statistics for new patients in less than 4 percent of interactions:~          health care providers in the public sectors of many developing countries routinely~          spend less than 1 minute per patient.~      To address these deplorably low standards in both medical knowledge and practice, the Liver~     Foundation in Kolkata has been working with private rural health care providers through~     capacity building activities to improve quality in the private sector. The program consists~     of multiple-week training to private rural health care providers on the basis of a~     well-developed curriculum in the district of Birbhum, West Bengal.~      This study aims to assess the impact of this training program using a randomized evaluation,~     in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's~     training program, or the control, i.e. no such training. As an independent outside~     evaluation team, we will run a baseline survey for all providers (through a third party data~     collection agency), monitor the application of and compliance in the Liver Foundation's~     training intervention, and conduct a final endline study. By comparing the treatment and~     control groups on a variety of measures developed to capture competence in provider~     knowledge and practice, we can rigorously assess whether such a training program for~     informal rural health care providers is an effective means of improving provider medical~     knowledge and practice in the short run. It is worth noting that this study will not be able~     to capture long run effects , such as price or location changes, on health care for the~     rural poor.~   "
58492|NCT02291562|"~     THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC~     can induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has~     anxiolytic and possibly antipsychotic properties, while not impairing memory and other~     cognitive functions. Instead, CBD has been shown to have significant neuroprotective~     effects. In humans, CBD values correlated positively with gray matter concentration in~     bilateral hippocampus. Recent data from experimental animals and in vitro studies suggest~     that these distinct effects might be caused by opposing effects on brain cannabinoid~     receptors.~      Neuroimaging studies have consistently identified brain activity recorded at prefrontal and~     medial temporal regions as relevant for episodic memory. Additionally, the abundance of~     cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices~     suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the~     evidence relating cannabinoids to these conditions is relatively recent and has been~     obtained from either biochemical or pharmacological studies. It might be hypothesized that~     CBDs could be useful to delay or even arrest the progression of functional and structural~     neuronal degeneration.~      The investigators will use an episodic memory paradigm to test the effects of THC, CBD and~     placebo on memory encoding and retention and the underlying neuronal networks on healthy~     male subjects.~   "
58493|NCT02291549|"~     The RESOLVE II Study will assess the safety and efficacy of the steroid-releasing S8 Sinus~     Implant when used in post-sinus surgery patients who present with recurrent sinus~     obstruction. This is a randomized, single-blind, parallel arm, concurrently controlled,~     multicenter study that will enroll 300 patients.~   "
58507|NCT02291367|"~     This study were to compare the relative bioavailability of Duloxetine HCl delayed release~     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed~     release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to~     monitor safety of subjects~   "
58508|NCT02291354|"~     The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal~     Microbiota Transplantation in Adult Patients with Slow Transit Constipation.~   "
58494|NCT02291536|"~     Attentional blink refers to a phenomenon where the detection of the second of two target~     stimuli that are presented in Short succession within a stream of stimuli is impaired. This~     is explained by an insufficient availability of attentional resources. Additionally,~     emotionally salient stimuli, like for example pictures with a positive or negative content,~     are detected more often compared to neutral pictures during this attentional blink period.~      Cannabinoids are involved in the modulation of cognitive, attentional, and emotional~     processes. Interestingly, data from animals suggests that THC and CBD, both active~     ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1)~     receptors. CB1 receptors modulate the expression of emotionally salient conditioned~     association in rats, if salience processes in humans are modulated in the same way remains~     unclear.~      Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC~     seems to make non-salient standard stimuli more salient. They showed decreased activation of~     the right caudate and increased right prefrontal cortex stimuli during processing of salient~     stimuli. Importantly, this was associated with decreased response times to standard relative~     to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated~     with attentional salience processing. For example THC seems to increase prefrontal and~     striatal activation whereas CBD seems to decrease it.~      The investigators assume that THC increases the number of correctly detected emotional~     stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the~     investigators assume that pictures of the positive category are detected with higher~     accuracy than negative ones under the influence of THC.~   "
58495|NCT02291523|"~     Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double~     blind, placebo controlled study. The safety and efficacy of the intervention will be closely~     monitored.~   "
58496|NCT02291510|"~     This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release~     metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR,~     ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.~   "
58497|NCT02291497|"~     Hypophosphatasia (HPP) is a rare, inherited metabolic disease caused by inactivating~     mutations in the Alkaline Phosphatase (ALPL) gene, coding for the Tissue-nonspecific~     alkaline phosphatase (TNAP). Penetrance and disease severity is very heterogenous, ranging~     from stillbirth to adult-onset manifestations. Especially the latter are again characterized~     by an extremely broad spectrum of symptoms. This scope of variability makes it difficult to~     attribute individual patients' symptoms to the disease and distinguish them from HPP~     independent health issues. Especially in adult HPP patients, musculoskeletal problems,~     including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular~     weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of~     disease, especially with respect these patients dis-abilities of daily life.~      To expand current knowledge of the natural history of the disease as well as on disease~     specific musculoskeletal deficits in HPP, all adult patients with established Diagnosis of~     HPP known at the Orthopedic Institute, University of Würzburg, will be offered to~     participate in a single, multimodal assessment of their disease history, current symptoms~     and disabilities, lab evaluations and clinical and technical analysis of their~     musculoskeletal status and capabilities.~      Patients will be invited to a day long visit to the clinic in order to perform the following~     assessments:~      A) Epidemiologic / anamnestic information B) Physical examination C) Structured~     questionnaires D) Laboratory examinations E) Clinical functional testing F) Technical~     Examinations~   "
58498|NCT02291484|"~     Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with~     standard stress testing in patients with stable chest pain complaints.~   "
58499|NCT02291471|"~     The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult~     Chinese Volunteers.~   "
58500|NCT02291458|"~     The South Asian population is facing an epidemic of type 2 diabetes, of which the underlying~     cause is still unknown. It is currently hypothesized that an ethnic susceptibility towards a~     disturbed energy metabolism may underlie this disadvantageous metabolic phenotype. In line~     with this, the investigators recently discovered that Dutch South Asian subjects have 32%~     lower resting energy expenditure (REE) and 34% lower energy-combusting brown adipose tissue~     (BAT) compared to matched white Caucasians. Nitric oxide (NO) was recently shown to be~     crucial for BAT development and, interestingly, South Asians have diminished NO~     bioavailability. Thus, the disadvantageous metabolic phenotype in South Asians may be caused~     by diminished NO bioavailability resulting in lower BAT volume. Therefore, the investigators~     hypothesize that increasing NO generation in the body by administration of L-arginine, the~     precursor of NO, will improve their metabolic phenotype by increasing BAT volume, thereby~     increasing REE and clearance of triglycerides and glucose by BAT. To investigate this, the~     investigators will perform a randomized placebo-controlled multicenter cross-over study in~     moderately obese Dutch South Asians and matched white Caucasians. Subjects will receive~     L-arginine (9 gram/day) or placebo for 6 weeks, followed by a wash-out period of 4 weeks and~     then again 6 weeks of one of either treatments. At the end of both treatment periods, a~     cold-induced PET-CT scan will be performed. Furthermore, muscle and fat biopsies will be~     obtained and thermoregulation will be assessed.~   "
58501|NCT02291445|"~     This is a pilot study to compare the relative bioavailability between two peppermint oil~     formulations, namely a colon-targeted-delivery capsule (Tempocol-ColoPulse®) and an~     enteric-coated capsule (Tempocol®). This study is conducted as part of a future multicenter~     randomized controlled trial that will assess the therapeutic effect of the new peppermint~     oil formulation in IBS patients.~   "
58502|NCT02291432|"~     To study the safety of autologous muscle-derived cells (AMDC) for the treatment of male~     stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.~   "
58504|NCT02291406|"~     Insulin resistance is a key reaction to surgery and trauma and reflects the degree of~     metabolic stress. With greater degree of insulin resistance the development of complications~     increase, in particular infectious complications. The aim of this study is to determine if~     robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to~     abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic~     clamp method. In addition inflammatory factors and clinical recovery will be measured.~   "
58510|NCT02291328|"~     Brassica vegetables are an important part of the investigators normal diet and are~     associated with a reduced risk of many chronic diseases. The protective effect may be as a~     result of the hydrolytic products of compounds contained within these vegetables, called~     glucosinolates. There is evidence that consumption of Brassica vegetables may cause~     compositional changes to the investigators gut microbiota. The aim of this study is to see~     whether a diet rich in Brassica alters the human gut microbiota composition, and~     specifically whether it causes an increase in the number of the beneficial bacteria known as~     lactobacilli.~   "
58511|NCT02291315|"~     Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis.~     However, postmenopausal Thai women consume diets which are habitually low in calcium due to~     lactose intolerance and dietary patterns which typically do not include milk-based products.~     The primary goal of this study is to measure the fractional calcium absorption from milk and~     a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with~     habitually low calcium intakes. The secondary objective is to determine associations between~     calcium absorption and biomarkers which impact vitamin D status and bone metabolism.~   "
58512|NCT02291302|"~     The investigators goal is to determine the efficacy of school/classroom based environmental~     intervention in reducing asthma morbidity in urban schoolchildren.~   "
58513|NCT02291289|"~     This randomized, multi-center, active-controlled, open-label, parallel-group study will~     investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line~     metastatic colorectal cancer (mCRC). Patients with mCRC are eligible for entry, and cannot~     have received any prior chemotherapy in the metastatic setting. The entire study duration is~     anticipated to be approximately 6 years.~   "
58514|NCT02291276|"~     In this prospective, observational study the investigators assess the perioperative course~     of right ventricular function in combination with the venous return in patients undergoing~     major non-cardiac surgery. The study aims to investigate if patients undergoing major~     non-cardiac surgery develop an impairment of right ventricular function and/or venous~     return. Furthermore, the study evaluates if an impairment of right ventricular function~     and/or venous return is associated to left ventricular function, arterial side of the~     circulation and to postoperative clinical outcome.~   "
58515|NCT02291263|"~     This study will be an open-label phase III randomized clinical trial comparing different~     combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV~     administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also~     receive bOPV at 6, 10 and 14 weeks of age.~   "
58516|NCT02291250|"~     Dietary strategies for alleviating health complications associated with type 2 diabetes~     (T2D) are being pursued as alternatives to pharmaceutical interventions. Berries such as~     blackcurrants that are rich in polyphenols may influence carbohydrate digestion and~     absorption and thus postprandial glycaemia. In addition berries have been reported to alter~     incretins as well as to have anti-oxidant and anti-inflammatory properties that may also~     affect postprandial glycaemia. This study investigated the acute affect blackcurrants on~     glucose metabolism in overweight/obese volunteers .~   "
58517|NCT02291237|"~     This study will evaluate the effect of eleclazine (GS-6615) on exercise capacity, quality of~     life, and safety and tolerability of eleclazine in participants with symptomatic~     hypertrophic cardiomyopathy (HCM).~   "
58518|NCT02291224|"~     This trial will evaluate a multi-component, clinic-based intervention aimed at increasing~     dual protection strategy selection and adherence among young African American females at an~     urban family planning clinic. Dual protection is the use of contraceptive strategies to~     prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is~     an unblinded randomized controlled trial; participants will either get the interactive~     multimedia platform focused on DP strategies with intervention arm counseling or the~     standard of care arm counseling.~      The study will recruit 710 African American females aged 14-19 who are attending the Grady~     Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health~     care.~      The trial will recruit and enroll 710 young women presenting to the clinic for clinical care~     who have the following characteristics:~        -  self-identify as African American,~        -  14-19 years of age,~        -  have had vaginal sex with a male partner in the past 6 months,~        -  HIV-negative by self-report,~        -  not pregnant,~        -  no desire to be pregnant in next 12 months,~        -  plan to stay in the Atlanta area for the next year,~        -  are willing to provide contact information, and~        -  were not previously enrolled in the pilot study of this intervention.~      Those enrolled will be in the study for 12 months. Young women who are eligible and give~     written consent or assent for study participation will be enrolled. Half will be randomized~     to the control arm, half to the intervention arm.~        1. Control arm (standard of care) includes individual clinical care and standard of care~          counseling consistent with protocols at the TSC, with study visits for data collection~          at enrollment, 6 months, and 12 months, during which any medical care or counseling~          that they would normally get will also be provided. Control arm participants will also~          get telephone calls from clinic staff to update their contact information and remind~          them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3~          weeks and 5 months after the 6 month visit.~        2. Intervention arm, consisting of the following intervention components:~             1. Enrollment visit~                  -  A culturally-appropriate interactive multimedia platform focused on DP~                    strategies and designed to prepare the individual for selection of a DP~                    strategy.~                  -  Individual intervention arm counseling to select the DP strategy that is best~                    suited for the participant (by a clinic health care provider).~                  -  Individual intervention arm counseling to build skills for correct and~                    consistent use of the selected DP strategy (by a nurse educator (NE)).~             2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment~               visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).~             3. 6 month visit~                  -  An abbreviated version of the interactive multimedia platform focused on dual~                    protection strategies and strategy adherence.~                  -  Individual intervention arm counseling to reinforce skills for correct and~                    consistent use of the DP strategy (by an NE).~      At the final study visit at 12 months there is no difference between the counseling provided~     to the two groups; participants in both arms will receive the clinic standard of care.~      Participants in both arms of the study will follow the same data collection procedures~     throughout the study:~        -  At all three study visits, participants in both arms will receive urine pregnancy and~          STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.~        -  At 3 and 9 months after enrollment, participants in both arms will receive a data~          collection call with administration of a telephone questionnaire.~      Throughout the study, all participants will be encouraged to come in for evaluation if they~     have any concerns. Any data from pregnancy or STI testing at these interim clinic visits~     will be later collected via chart review. If participants seek reproductive health care at~     other facilities during the study period, records will be requested with participant~     permission, and data from pregnancy or STI testing at these outside clinic visits will be~     collected via review of records received.~      We will examine the efficacy of the intervention arm relative to control arm across the~     following primary behavioral and biologic outcomes over the 12 months of follow-up:~        1. Self-reported dual protection strategy selection~        2. Self-reported dual protection strategy adherence~        3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as~          confirmed by laboratory testing)~      A small pilot study was be conducted prior to the initiation of enrollment in the main~     study.~   "
58519|NCT02291211|"~     This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic~     intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery~     (CRS)~   "
58520|NCT02291198|"~     This study will look at measuring the activity of natural killer (NK) cells using the in~     vitro diagnostic device NK Vue in subjects being screened for colorectal cancer using~     colonoscopy. The NK Vue diagnostic test for natural killer cell activity uses the principle~     of stimulation of whole blood with a proprietary cytokine followed by the quantitative~     detection of interferon gamma using an immunoassay. NK Vue is intended to be used for the~     monitoring of the immune status of individuals. Measurement of NK cell activity could be a~     useful tool for assessing changes in immunosurveillance in patients with conditions or~     diseases where NK cell activity has been shown to be reduced, such as colorectal cancer.~   "
58521|NCT02291185|"~     The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery.~     Hemodynamic instability is frequently encountered problem associated with BCP. In addition,~     high rates of cerebral desaturation events have been reported during surgery in BCP.~     Although fluid loading could alleviate hypotension associated with BCP, it may lead to~     volume overload. As an alternative to static indices, dynamic preload indices such as pulse~     pressure variation (PPV) and stroke volume variation (SVV) were reported to be sensitive~     predictors of fluid responsivness in several surgical condition. The investigators will~     examine the abilities of PPV and SVV to predict fluid responsivness during shoulder~     arthroscopic surgery in BCP. Using transesophageal echocardiography (TEE), the investigators~     will directly estimate the change of cardiac output during BCP.~   "
58522|NCT02291172|"~     Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children~     with Autism is to conduct an efficacy study of a promising intervention to increase spoken~     language in preschool children who are minimally verbal. The proposed study compares a~     comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU)~     control group in a randomized controlled trial (RCT) across 4 time points. The study~     replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully~     promote social communication in older minimally verbal children. Intervention components~     include: (1) Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu~     Teaching (JASP- EMT), (2) applied with systematic parent training, (3) use of speech~     generating device (SGD) and (4) supplementary direct teaching of foundational skills for~     language learning as indicated by child entry skills (CORE-DTT; Smith, 2009). Children who~     remain minimally verbal beyond age 5 are at high risk for persistent, severe communication~     deficits that impact social development, educational achievement and quality of life~     (Tager-Flusberg & Kasari, 2013). Thus, there is an urgent need for effective strategies to~     promote communication development during the preschool years to ameliorate early~     communication deficits and prevent persistent minimally verbal status. This study aims to~     change social communication in minimally verbal preschool children with ASD by applying a~     naturalistic social communication intervention which teaches the social foundations of~     communication and functional use of verbal language in play and interaction. In addition,~     the intervention addresses three factors that may contribute to remaining minimally verbal:~     lack of an effective mode of speech production, lack of foundational skills for learning~     language (receptive language, imitation, joint attention), and lack of communication~     partners to support continued language learning in natural environments.~   "
58638|NCT02289651|"~     We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for~     intubation of pediatric manikins while performing CPR. In the current study, we compared~     effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child~     resuscitation with and without CC.~   "
58523|NCT02291159|"~     Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow.~     The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling~     technique to reduce spasticity and hypertonia and improve function in patients with CNS~     injury. The main objective of this trial is to analyze the therapeutic effect of DNHS®~     technique in motor function in patients between 45 and 80 in a chronic state after a stroke.~     Methods: Double-blinded randomized clinical trial. There will be an intervention group~     (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per~     week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor~     pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth~     Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed~     as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90%~     confidence limit) in the selected variables will be calculated.~   "
58524|NCT02291146|"~     The overall goal of this project is to conduct a randomized controlled 12-week after school,~     gardening, nutrition and cooking program (called LA Sprouts) to improve dietary intake and~     reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles.~     Approximately 400 3rd - 5th grade students participating in the LA's Best after school~     program will participate. Four elementary schools in Los Angeles will be selected to~     participate in the study. Schools will be randomized by region to either receive the~     intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a~     delayed intervention program one school semester later; 2 schools, n=200 students). The LA~     Sprouts intervention will take place at the elementary schools, with gardens on campus~     specially designed and built for this project. The program will be held once a week for 12~     weeks and will consist of a 45-minute gardening lesson, taught by Master Gardeners from the~     University of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a~     45-minute nutrition education and cooking lesson, taught by USC a Nutrition Educator~     (supervised by Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index~     (BMI) and body fat percentages), blood pressure, metabolic function (fasting blood glucose,~     insulin and lipids), dietary intake and related behaviors, and school performance will be~     measured before and after the implementation of the program in both intervention and control~     participants. Approximately 10 additional students of the same age will be asked to~     participate in a focus group to evaluate the questionnaire developed for this study. In~     addition, approximately 20 additonal students of the same age will be asked to participate~     in a test-retest session to validate the reliability of the questionnaire.~   "
58525|NCT02291133|"~     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with~     bleomycin in treatment of primary liver tumors in clinical study phase I and II.~      The study will include 10 patients in phase I clinical study and additional 15 patients in~     phase II clinical study (or in the extension of the clinical study), which will fulfill~     inclusion criteria.~      Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events~     in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness~     of the treatment will be evaluated by modified RECIST criteria, which will take into account~     difference in size and density, determined from images obtained by CT perfusion of the~     treated tumor nodules before and after ECT. Tumor volume will be calculated by following~     formula , where a will be shorter and b longer tumor diameter.~      The secondary objectives of the trial are to quantify the impact of the treatment on the~     patient's quality of life, tolerance to the therapy and suitability for larger study to be~     conducted.~   "
58526|NCT02291120|"~     The objective of the study is to evaluate and compare, clinically and radiographically,the~     effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human~     primary molars.~   "
58527|NCT02291107|"~     In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that~     strongly influence patient quality of life. The improvement of walking ability is a primary~     goal for rehabilitation treatment. Current promising rehabilitative approaches for~     neurological disorders are based on the concept of the task-specific repetitive training.~     Hence, the interest in automated robotic devices that allow this typology of treatment for~     gait training. However, studies on the effectiveness of such methodologies are still poorly~     numerous in terms of functional improvement in MS patients. The aim of this controlled~     cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients~     affected by Multiple Sclerosis in comparison to a ground conventional gait training.~   "
58528|NCT02291094|"~     This study aims to compare quality of perioperative analgesia of lidocaine and remifentanil~     intravenously in surgical interventions for the treatment of breast cancer.~   "
58529|NCT02291081|"~     The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted~     to assess the incidence, the prevalence and the clinical course of cardiovascular diseases~     (CVD) in HIV-infected patients. The study population includes outpatients from specialized~     HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to~     have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion~     into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+~     patients were recruited in a consecutive manner. The standardised examinations included a~     targeted assessment of medical history and physical examination. Blood was drawn for~     comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA~     levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters).~     Furthermore, non-invasive tests were performed during the initial visit, including~     additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and~     transthoracic echocardiography (TTE). Examinations were completed in accordance with~     previously defined standard operating procedures. CVD were defined as coronary,~     cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.~   "
58530|NCT02291068|"~     The Objectives of the current research is to evaluate whether psychological flexibility~     influences psychotherapy outcomes in patients with adjustment disorder and depression. If~     indeed this is the case, we would be able to identify risk factors for low adjustment- such~     as low psychological flexibility, and develop psychotherapy that would try to enhance this~     ability.~   "
58639|NCT02289638|"~     We hypothesized that the Intubrite Video Laryngoscope System VLS 6600 is beneficial for~     intubation of pediatric manikins while performing CPR. In the current study, we compared~     effectiveness of the Intubrite and MIL laryngoscopes in child resuscitation with and without~     CC.~   "
58531|NCT02291055|"~     Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and~     tolerability of the combination and to identify a RP2D.~      Part B:~      Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or~     MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for~     their recurrent/persistent or metastatic cervical cancer.~   "
58532|NCT02291042|"~     This study evaluates the ability of a belladonna and opium suppository given prior to~     surgery to improve bladder comfort after surgery for patients who are having elective~     cystoscopy surgery.~   "
58533|NCT02291029|"~     This study will evaluate the safety,tolerability and preliminary therapeutic efficacy of~     multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with~     primary Sjögren's syndrome(pSS)~   "
58534|NCT02291016|"~     The purpose of this study is to compare drug delivery and lung function after treatment with~     formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from~     severe exacerbations of COPD. This is to determine if one device is superior in providing~     better lung function and drug deposition in this clinical setting.~   "
58535|NCT02291003|"~     Circadian clocks are not only found in discrete areas of the brain, but are found in~     virtually every organ in our bodies, including the heart, lungs and immune system.~     Disruptions in circadian clocks, or chronopathology, may underlie various forms of~     cardiovascular, pulmonary, and metabolic disorders. Over the past two decades, molecular~     geneticists have cracked the clock to reveal its core biochemical mechanisms evident in~     organisms from fruit flies to humans. These mechanistic insights have led to the discovery~     of links between clock function and an ever-expanding array of prevalent diseases, including~     heart, lung, metabolic and sleep disorders. Yet the prevalence of circadian disruption in~     these patient populations is unclear because current tests are not easily applied in~     clinical settings or have yet to be developed. Here the investigators exploit our newfound~     understanding of clock mechanisms and the development of new genomic technologies to~     identify novel complements of clock-regulated genes (signatures) that will reveal the~     state of the internal biological clock. This approach will allow us to take a genomic~     snapshot of clock status from a single blood draw, substantially easing the diagnosis of~     these individuals with evidence of circadian disruption or misalignment, i.e.,~     chronopathology.~   "
58536|NCT02290990|"~     Imaginative Distention (ID) is proposed as supportive and integrative intervention to cope~     with fatigue, (principal end point), to cope with insomnia, stress perception and to improve~     QoL of pw MS, insomnia pw and health care personnel. ID is safe and it can be easily learned~     and practised without of any particular instrument and also feasible in disabled pw. This~     technique allows persons to experience the body as a source of well-being and not just~     fatigue, pain and disease. ID can become a self managed tool of empowerment to cope with MS,~     to reduce its negative impact on daily life and job performances. Adherence to~     pharmacological therapies could be improved using ID.~      For pw MS ID could have specific and customizable rehabilitation implications to improve~     motor disability, as already seen in stroke patients. The principal end point of the trial~     is verify ID efficacy on fatigue and its specificity on pw MS at the end of the training.~     For this reason, ID efficacy will be tested in comparative terms too. Among all possible~     comparison populations, we selected: pw insomnia, which is stress related disease and health~     personnel, because at risk of stress. The control groups comparison permits to evaluate the~     specificity of ID on pw MS. The three groups are randomised to intervention or waiting list.~     The training is 8 weekly session long. Self administered questionnaire are filled by~     participants before and after the training, and 3-6 months later. The extent of change in~     outcome measure monitored in each exposed group vs. unexposed will allow to separate the~     non-disease specific effect of ID from the MS-specific effect. The difference in estimates~     will allow to determine the extent of the true effect of ID in pw MS. All outcome measure~     will be compared among all groups mentioned and over time. The study would identify also the~     most important outcome measures for MS patients questioning them in a focus group. This~     aspect is very important because could differs from which clinicians and researchers think~     about.~   "
58537|NCT02290977|"~     The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular~     carcinoma (HCC) is one of the most significant prognostic factors for poor prognosis,~     without treatment, their survival is less than 3 months. In the HCC patients who combined~     with PVTT, Radiation therapy (RT) showed 50% of local control and about 10 months survival~     duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but~     Korean Liver Cancer Study Group (KLCSG) recommend RT as an alternative option in those~     patients. Investigators previously reported the retrospective study that the scheduled~     interval Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined~     with PVTT and 60% of the patients showed objective response without significant elevation of~     complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly~     reported. Based on those background, we start this prospective study to evaluate the~     clinical outcomes and adverse event in the RT after TACE in the unresectable HCC patients~     who combined with PVTT.~   "
58538|NCT02290964|"~     This study is aimed to determine if acute normovolemic hemodilution (ANH), an established~     blood conservation technique, reduces the requirement for allogeneic blood transfusion in~     operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)~   "
58539|NCT02290951|"~     This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV~     (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of~     REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia~     (CLL)~   "
58540|NCT02290938|"~     The investigators plan to develop and test a new alcohol and other drug (AOD) intervention~     for urban AI/AN youth, Motivational Interviewing and Culture for Urban Native American~     Youth (MICUNAY). This intervention integrates tradition-based activities and motivational~     interviewing (MI). The investigators will intervene at both the community and individual~     level. At the individual level, they will provide MICUNAY to adolescents. At the community~     level, they will provide discussion of AOD prevention at Community Wellness Gatherings~     (CWG). This work is important because they will gain an understanding of how well a~     tradition-based healing program that integrates MI works to prevent AOD use among urban~     AI/AN youth.~   "
58541|NCT02290925|"~     The investigators intend to conduct a double blind randomized clinical trial to investigate~     the effect of a biscuit containing herbal extract, available in the market on the fasting~     blood sugar control in patients with diabetes mellitus and also to find out whether there~     are any side effects on other vital organs such as kidneys and liver.~   "
58542|NCT02290912|"~     This is a randomized controlled trial to develop and test the efficacy of a multi-domain~     lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked~     to lower Alzheimer's disease risk among persons aged 40 to 64 years.~   "
58543|NCT02290899|"~     The main purpose of this study is to investigate how the brain responds to a procedure known~     as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a~     behavioral task. Research suggest that this procedure leads to improvement in brain and~     behavioral measures of inhibitory control (controlling impulses) in healthy control~     participants. The investigators want to explore whether the same improvement will be seen in~     kids with ADHD.~   "
58544|NCT02290886|"~     A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to~     evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal~     stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
58545|NCT02290873|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open-label arm for~     midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.~   "
58546|NCT02290860|"~     Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first~     recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the~     diagnostic criteria used and the population being studied.~      GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus~     (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM~     postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance~     test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S~     recommendation has failed worldwide for the same reasons: the presently impractical pattern~     of the testing. A solution is direly needed.~      Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically,~     to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.~      We hypothesize that, in GDM women, results of an OGTT performed after delivery, before~     hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks~     postpartum (OGTT-2). Our aims are:~        1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of~          OGTT-1 established by our Stage-1 study.~        2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the~          2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.~        3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12~          weeks postpartum).~      If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum~     OGTT will be avoided. Medical practice will change.~   "
58547|NCT02290847|"~     The primary objective of this study is to evaluate the effectiveness of Cognitive Processing~     Therapy (cognitive only version; CPT-C) delivered using two different formats in the home~     setting for the treatment of combat-related PTSD as compared to conventional face-to-face~     CPT-C delivered in a mental health clinic. The study will include two different formats of~     in-home therapy: face-to-face in-home CPT-C and tele-behavioral health in-home CPT-C.~   "
58548|NCT02290834|"~     This research study evaluates the effect of chemotherapy on cognition (thinking) and the~     brain in people with breast cancer.~   "
58549|NCT02290821|"~     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction~     of the pain associated with acute blunt trauma injuries.~   "
58550|NCT02290808|"~     This study will be investigating whether a theory-based physical activity intervention can~     maintain/improve moderate to vigorous intensity physical activity measured via accelerometry~     of new parents over the eight months of having a child compared to a control group of new~     parents.~      Hypothesis: The theory-based condition will change salient underlying motives (theory of~     planned behaviour constructs) for physical activity. Health-related fitness and quality of~     life will also be higher for this condition in comparison to the control condition. (Note:~     improvements in both groups of mothers may occur due to recovery from pregnancy, but our~     hypotheses will still hold). All outcomes will remain significantly higher at eight months~     in the theory-based condition compared to the standard condition~   "
58551|NCT02290795|"~     The vitreous fills the posterior chamber of the eye and is firmly attached, at the posterior~     pole, to the macula and the optic nerve head (ONH). With formation of a stepwise posterior~     vitreous detachment (PVD) exerted tractional forces could influence retinal functioning.~     Especially in patients with glaucoma the influence of vitreous traction to the ONH could~     mask progression, interfere with current imaging techniques and even be a cause of ONH~     hemorrhages. Therefore the aim of this study is to investigate whether vitreopapillary~     traction has a significant effect on diagnosis and follow up of glaucoma patients.~   "
58552|NCT02290782|"~     This prospective, multicentric single arm phase IV study is based on the protocol of the~     international TARGIT-A and TARGIT-E study.~      Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated~     show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy~     (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).~      It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in~     a selected group can be non-inferior to WBRT.~      The TARGIT C study should confirm the efficacy of a single dose of intraoperative~     radiotherapy (IORT) in a well selected group of patients with small breast cancer and~     absence of risk factors. In presence of risk factors postoperative WBRT will be added to~     complete the radiotherapeutic treatment according to international guidelines.~      Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse,~     cancer-specific and overall survival and contralateral breast cancer as well as~     documentation of quality of life and cosmetic outcome.~      The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively.~     Discontinuation of the trial is scheduled if rates of local relapse rates rise to~     1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated~     dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will~     be only a pre-pathology stratum.~      It is a pragmatic trial in which each participating centre has the option to modify entry~     criteria and criteria for WBRT according to this core protocol after consultation with the~     steering committee and local ethics committee (e.g. size, free margins). Only centers with~     access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.~   "
58553|NCT02290769|"~     The aim of this study is to compare the cannulation time during primary wire guided ERCP~     (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide~     wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.~   "
58554|NCT02290756|"~     The investigators propose to develop and test the efficacy of a low cost evidence based~     toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The~     toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord~     care, hypothermia management, aspiration and bag and mask techniques and APGAR score~     calculation. A simple, home-based parenting program will also be implemented that will teach~     parents tools that provide stimuli for brain and cognitive development in children. This~     parenting program covers Early Childhood Interventions for children at risk of developmental~     problems and covers developmental skill areas such as cognitive and fine motor, social and~     self-help and gross motor skills. Such an intervention package provides comprehensive care~     to families at the community level, with a minimal cost that can be scaled up. A new cadre~     of Link workers will be implemented who will provide mentoring and supportive supervision to~     Birth Attendants and will train parents in the stimulation program. The study will recruit~     1080 pregnant women and their newborns.~   "
58555|NCT02290743|"~     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength~     of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength~     in the quadriceps femoris - a randomized controlled trial.~   "
58556|NCT02290730|"~     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength~     of the lower trapezius in people with shoulder symptoms and decreased muscle strength in the~     lower trapezius - a randomized controlled trial.~   "
58557|NCT02290717|"~     Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life.~     Many depigmented lesions in vitiligo patients remain therapy resistant for medical~     treatment. Therefore new therapeutic options in these patients are necessary. Currently,~     dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy~     and steroids appears to be effective in therapy resistant areas. However, little literature~     on this combination is available.~      Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment~     in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB~     and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective~     observer blinded randomised intra-patient controlled study.~      Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB~     treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical~     Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are~     resistant to NB- UVB treatment after 3 to 6 months.~      Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be~     randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser~     abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and~     topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will~     be given according to the standard treatment protocol of the SNIP and continued for at least~     6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of~     the lesions will be assessed.~   "
58558|NCT02290704|"~     Find if the retinal function is affected in both the nonsevere and the severe stage of~     Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with~     that of normal people.~   "
58559|NCT02290691|"~     The purpose of this study is to determine if the administration of flu vaccine using~     Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory~     tests of immune response.~   "
58560|NCT02290678|"~     Team building exercises have been shown to be effective in improving an individual's ability~     to work within a group and build working relationships with others. Adventure Therapy~     assimilates team building exercises and teachings into an adventure style excursion into the~     wilderness or other non-typical environment. This combination of exposure and learning~     creates a unique experience for participants which preliminary research suggests is~     effective in reducing feelings of hopelessness, guilt, and shame and may increase empathy,~     self-concept, self-confidence, and subjects' well-being have also been shown to be improved~     by adventure therapy.~      This study will use a series of questionnaires and interviews to determine whether an~     adventure based therapy is both effective and reasonable as a treatment for people with mood~     disorders like depression and anxiety. The objective of this study is to investigate the~     efficacy of adventure based therapy as a treatment intervention for outpatients with mood~     disorders. The investigators will observe any changes in mood, perceived self- efficacy,~     anxiety, self-stigma, hope, quality of life enjoyment and satisfaction, leisure motivation,~     and stress as a result of this intervention. As well, the investigators aim to capture~     participant's opinions of the program.~   "
58561|NCT02290665|"~     The purpose of this study is to determine the patient preference for a biocompatible~     thermosensitive solution-gel versus water or saline (liquid) enema.~   "
58562|NCT02290652|"~     -  Non-commercial trial~        -  2 Centres involved: University Hospital Southampton and Spire Southampton~        -  Expected number of eligible participants available per year: 100, (95% expected to~          agree to participation)~        -  The study will recruit prospectively female patients aged 18 - 65 years undergoing THR.~          A retrospective series of similar patients who have had a hip replacement will also be~          recruited.~        -  This is a research project that will run over 2 years. Data from 200 patients will be~          collected and analysed:~      Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire~     (ASFQ) - Post-operative' Version 1.3 11/07/14~      Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ)~     - Pre-operative' Version 1.3 11/07/14~      This project is significant in exploring an area of Orthopaedic medicine that has been~     little discussed in the literature. Preliminary results of our questionnaires have already~     revealed patients have a great desire to know how hip replacement will affect sexual~     function. Components of the questionnaire look at details such as: reasonable time frames~     for returning to sexual activity, positions that may be undesirable following replacement~     and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of~     total hip replacement surgery. The ultimate objective is to provide patients with detailed~     information about what to expect after hip replacement surgery.~   "
58574|NCT02290496|"~     This study is a randomized controlled trial that tests the effectiveness of cognitive~     behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who~     have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is~     compared with a control condition of sleep hygiene education.~   "
58563|NCT02290639|"~     A significant number of veterans of the wars in Iraq and Afghanistan are affected by~     posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD~     into the veteran population is at least partially due to the perceived stigma by service~     members for seeking help in traditional specialty mental health clinics. A comprehensive~     approach to PTSD treatment in a veteran population should provide alternative sources for~     accessing effective psychotherapy treatments. The purpose of study is to conduct a~     randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks)~     cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral~     health consultants working in an integrated primary care setting to a minimal contact 6-week~     control. The primary outcome measure is PTSD symptom relief.~   "
58564|NCT02290626|"~     Study 1: A randomized, crossover trial using elemental or semi-solid diets containing~     contrast medium as a tracer given to bedridden PEG patients. The distribution of the~     administered diets is assessed at the distal esophagus, proximal and distal stomach using a~     plain CT before and 1 hour after the administration.~      Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C~     sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed~     to estimate gastric emptying.~   "
58565|NCT02290613|"~     Trial Design Patients with borderline PAH indicated by borderline mPAP values will be~     included in this single centre study. This clinical investigation is performed as a~     Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized,~     double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their~     first visit their medical history will be obtained and physical examination will be~     conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid~     and other laboratory tests), echocardiography at rest and right heart catheterization will~     be carried out. If patients have been identified within the last 6 months before screening~     investigations by right heart catheterization, the measurements are considered valid as~     baseline investigations and will not be repeated. If patients fulfill the inclusion criteria~     and still suffer from borderline mPAP values they will be invited to join the study. The~     clinical investigations will begin within 28 days. The prospective study will comprise a 6~     months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up~     phase of 30 ±7 days.~   "
58566|NCT02290600|"~     The purpose of this 12 week feasibility study is to see how much more accurate a continuous~     glucose monitor (CGM) might be in individuals with type 1 diabetes if the investigators~     personalize sensor calibrations to the user, based on previous wear.~   "
58567|NCT02290587|"~     In recent years, studies have brought knowledge of the difficulties of social cognition in~     Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in~     social cognition mechanisms remain poorly understood. Although recent behavioral studies~     indicated social disturbances in many of these patients, functional studies investigating~     specific theory of mind in MS are lacking. The use of new techniques for morphological and~     functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping~     the achievement and tissue integrity may be related to disorders of social cognition and~     cognitive. The investigators propose to study social cognition in MS patients using~     morphological and functional imaging to determine the mechanisms underlying phenomena such~     as cerebral compensation and its relationship with cognitive impairment.~   "
58568|NCT02290574|"~     The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent~     chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently,~     laparoscopic surgery is getting substitute open surgery based on the advantages of early~     recovery, short admission, less pain, less blood loss, and little scar without compromising~     oncologic outcomes.~      It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure,~     acidic, and low perfusion site which are known as radio-resistant. Because of these~     characteristics, it considered as the most valuable radiosensitizer in cancer treatment,~     theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor~     reoxygenation.~      Based on those background, the investigators start this prospective study to evaluate the~     efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.~   "
58569|NCT02290561|"~     The purpose of this study is to assess how accurately SmartTarget can direct high intensity~     focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.~      The current standard methods for treating prostate cancer are directed to the whole gland -~     either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is~     surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy~     tissue.~      Prior to surgery prostate cancer can often be localised using MRI imaging and detailed~     prostate biopsy techniques. The difficulty is that during surgery it is very difficult to~     accurately locate the cancer on the live ultrasound images - to compensate surgeons will~     treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause~     higher rates of side-effects.~      SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the~     live ultrasound during surgery. It then provides a target for the surgeons to treat during~     the operation.~      The results will measure if the area intended to treat was covered and if how accurate the~     treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan~   "
58570|NCT02290548|"~     The purpose of this study is to determine whether high flow nasal cannula is effective in~     lowering the reintubation rate after extubation for high risk patients in medical intensive~     care unit~   "
58571|NCT02290535|"~     The investigator will determine a compliance of two diagnostic techniques (EIT and Body~     plethysmography) in collective of children and teenagers with obstructive lung disease and a~     matched control group.~   "
58572|NCT02290522|"~     Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA~     for identification of pts who could benefit from a personalized treatment.~   "
58573|NCT02290509|"~     Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus~     Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of~     age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days~     post-vaccination. Subjects will be followed for 6 months after vaccination for serious~     and/or medically-attended adverse events.~   "
58575|NCT02290470|"~     This randomized, pilot study explores the activity of olanzapine with or without delayed~     dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic~     cancer receiving the combination of carboplatin and paclitaxel. Women treated with this~     regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given~     anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in~     women receiving carboplatin and paclitaxel.~   "
58576|NCT02290457|"~     Background: It has been demonstrated that core strength training is an effective means to~     enhance trunk muscle strength (TMS) and athletic performance in youth. However, the role of~     instability with core strength training is unresolved in youth. This study specifically will~     investigate the effects of core stability (CST) compared to core instability strength~     training (CIST) on physical fitness in adolescents.~      Methods: Twenty-seven (14 girls, 13 boys) healthy adolescents (age 14±1 years) will be~     assigned to a CST (n=13) or a CIST (n=14) group. Both training programs will last 6 weeks (2~     sessions/week) and included frontal, dorsal, and lateral core exercises. During CIST, these~     exercises will be conducted on unstable surfaces (e.g., TOGU© DYNAIR CUSSIONS, THERA-BAND©~     STABILITY TRAINER).~      Expected Results: Based on selected results reported in the literature, we hypothesize that~     participants performing CIST as compared to CST will show larger improvements in physical~     fitness tests (i.e., strength, speed, flexibility, coordination, balance) following~     training. Of note, training induced gains in strength, speed, flexibility, coordination, and~     balance are of vital importance for sports performance, everyday activities, and injury~     prevention.~   "
58577|NCT02290444|"~     The purpose of this study is to evaluate the effect of a medication called Acthar on~     recovery from multiple sclerosis-related relapses that impact cognition.~   "
58578|NCT02290431|"~     The purpose of this study is to evaluate the efficacy and safety of panobinostat in~     combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory~     multiple myeloma.~   "
58579|NCT02290418|"~     The aim of this study is to compare the relative clinical outcomes between two variants of~     gastric bypass [Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)] in~     metabolic surgery candidates with Body Mass Index (BMI) between 35 and 50. The study will~     examine the short and medium term effects of each intervention on weight, obesity~     comorbidities, quality of life and gastroscopy findings.~   "
58580|NCT02290405|"~     The purpose of this study is to learn more about people with insomnia disorder and cognitive~     impairment. Cognitive impairment is difficulty with mental abilities such as thinking,~     knowing and remembering.~   "
58581|NCT02290392|"~     Background:~      - High blood pressure is a common problem. It can cause heart attacks, strokes, and kidney~     failure. It affects African Americans more than other racial groups. Data were collected~     from over a thousand African Americans across the country. The data were put into a database~     (MH-GRID). The data were about genes, diet, sleep, body mass index. They also cover stress~     and access to healthy foods and parks. Researchers at NIH will study these data in new ways.~     They want to learn more about the connection between African Americans and high blood~     pressure.~      Objective:~      - To study MH-GRID data to find the causes of severe high blood pressure and other~     cardio-metabolic problems in people of African ancestry.~      Eligibility:~      - African Americans age 30 55 with severe high blood pressure were used in the MH-GRID~     study. No new participants will be enrolled in this study.~      Design:~      - Researchers will examine data from the MH-GRID study.~   "
58582|NCT02290379|"~     Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety~     and tolerability study of TNX-201 capsules in healthy volunteers.~   "
58583|NCT02290366|"~     The standard options for men with very low risk prostate cancer include active surveillance~     and the standard treatment options for low risk disease, i.e. radical prostatectomy,~     external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks~     to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk~     prostate cancer. The goals of the study are to determine the biochemical disease free~     survival at five years in these patients, as well as to determine the acute and late~     urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using~     Cesium 131. Patients eligible for the study will be men with histologically confirmed~     adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6,~     prostate specific antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores~     positive out of a minimum of 12 cores sampled. Additionally, patients must have a single,~     dominant index lesion on MRI. The study is a phase II study. Patients will be followed~     prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every~     three months in year one and every six months from year two through year five. Urinary,~     bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two~     weeks, after treatment, at three month intervals in year one and at six month intervals in~     years two through five.~   "
58584|NCT02290353|"~     The investigators have assembled an integrated knowledge/technology/client team to develop a~     novel motion capture-based home therapy program for children with hemiparesis (cerebral~     palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society~     needs new approaches to improve the quality of life for millions of Canadians. The method~     proposaed here is to combine low-cost motion capture devices, a bimanual training program,~     social media frameworks such as Facebook Games, and on-line performance sharing between~     therapy clients and with their therapists. The investigators believe that together these~     approaches will yield interventions for people with stroke and children with hemiplegia that~     significantly improve their motivation to continue their exercise programs and thus improve~     their functional ability which will lead to improved quality of life.~   "
58585|NCT02290340|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an~     extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to~     placebo when administered to healthy preterm infants.~   "
58586|NCT02290327|"~     The purpose of the this Pilot Trial is to determine the feasibility of conducting a large~     randomized controlled trial (RCT), that aims to examine the efficacy and safety of using~     pantoprazole compared to placebo for stress ulcer prophylaxis in critically ill mechanically~     ventilated patients in the ICU.~   "
72185|NCT02112526|"~     To characterize the safety profile of ACP-196 in subjects with relapsed or refractory de~     Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).~   "
58587|NCT02290314|"~     Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on~     an adjacent vertebra resulting in narrowing of the spinal canal or compression of the~     exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent~     reason for spine surgery particularly in individuals over age 65 years. Recently novel~     minimally invasive surgical techniques have heightened public and government interest by~     touting benefits of reduced approached-related morbidity which in turn leads to quicker~     recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health~     care cost. However, there is no randomized controlled trial evidence to describe the actual~     advantages and disadvantages associated with minimally invasive spinal fusion. This pilot~     study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion~     (MIDLF) to traditional open posterior lumbar interbody fusion (PLIF) with respect to~     length of stay, approach related morbidity, patient centered outcome measures, and~     cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.~   "
58588|NCT02290301|"~     The primary objective of the study is to investigate cardiovascular safety of gemigliptin by~     evaluating the time until patients report with major adverse cardiovascular events (MACE) in~     T2DM patients treated with gemigliptin.~      Study patients will be followed up to 4 years until MACE occurrence or until the patient~     drops out of the study or completion of the study. The patient who switches to a~     non-gemigliptin treatment after initiating gemigliptin therapy will be followed until MACE~     occurrence or until the patient drops out of the study or completion of the study.~      The secondary objectives of the study are to evaluate adverse events related as well as~     not-related to MACE in diabetic patients treated with gemigliptin.~   "
58589|NCT02290288|"~     The study is carried out at the Sahlgrenska University Hospital and the patient population~     consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault~     prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either~     vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one~     of the types of surgery. The primary outcome is anatomical failure based on clinical~     assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse~     Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one~     and two years after the surgery. Secondary outcomes are evaluation of continence, sexual~     function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after~     the surgery.~   "
58590|NCT02290275|"~     The goal of this research project is to determine the effectiveness of creatine~     supplementation and supported low-load walking exercise for managing systemic inflammatory~     biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee~     osteoarthritis. The central hypothesis of this investigation is that creatine~     supplementation and exercise will significantly lower systemic biomarkers of inflammation in~     patients diagnosed with knee osteoarthritis.~   "
58591|NCT02290262|"~     Background: Patients undergoing coronary artery bypass graft surgery often experience a~     range of problems and symptoms related to the procedure and the underlying heart~     disease.These problems include anxiety and depressive symptoms, immobility issues,~     complications such as wound seeping, neck and shoulder pains, interrupted and insufficient~     sleep. No studies have tested a combined intervention on phase 1 rehabilitation in coronary~     artery bypass graft surgery patients. However, randomised trials with either a physical or a~     mental part have been conducted with positive result, but evidence is lacking for a combined~     intervention. Before a large randomised trial was set up a pilot trial was conducted to~     evaluate the feasibility of patient recruitment and intervention: to test the safety and~     tolerability of the intervention by patients and to provide outcome data for sample size~     calculations. The SheppHeartCABG pilot showed trial feasibility, safety and sufficient~     inclusion rate and high compliance with most elements. Outcome data from the pilot trial has~     been used to sample size and power calculation in this randomised clinical trial.~      Objective: The objective of this trial is to investigate the benefits and harms of a phase 1~     comprehensive cardiac rehabilitation programme consisting of an exercise-training and a~     psycho-educative component, including plus treatment as usual in patients who undergo~     coronary artery bypass grafting.~   "
58592|NCT02290249|"~     Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to~     improve teaching intubation. The investigators want to find their efficacy in normal airway,~     tongue edema and face-to-face orotracheal intubation models by novice personal.~      Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six~     medical students who were on the beginning of their third year were enrolled in this study.~     After watching a video about the intubation of one of these devices, they attempted to~     intubate an adult manikin in three different airway models in a random order; first in~     normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face~     approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times,~     success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.~   "
58593|NCT02290236|"~     The overall aim with this project is to describe the correlation between measured and~     charted saturation after intensive care and also describe the saturation-pattern in these~     patients. The investigators will also correlate post-ICU desaturations measured as oxygen~     denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG~     screening questionnaire.~   "
58594|NCT02290223|"~     Will a primary care-based behavioral intervention for patient activation and engagement and~     self-management, for patients with chronic pain who are taking opioid pain medication,~     result in better patient outcomes than Usual Care?~   "
58595|NCT02290210|"~     The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in~     gout patients with hyperuricemia~   "
58619|NCT02289898|"~     This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic~     pancreatic ductal adenocarcinoma.~      The purpose is to test the efficacy and safety of demcizumab, when given in combination with~     gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and~     Abraxane® is a standard treatment for patients with metastatic pancreatic ductal~     adenocarcinoma.~   "
58620|NCT02289885|"~     The study evaluates the knowledge, attitude and practice about Focused Assessment with~     Sonography in Trauma among emergency medicine practitioners in Poland.~   "
58596|NCT02290197|"~     Knee dislocation is a serious injury, usually caused by high-energy trauma. It is~     classically defined as complete loss of articular congruence between the femur and the~     tibia, confirmed by radiography. However it is common that the reduction happens~     spontaneously. For this reason, today the investigators also consider a patient suffered~     knee dislocation in the presence of multi-ligament injury involving the posterior cruciate~     ligament, often in association with anterior cruciate ligament, lateral and/or medial~     ligamentous complex.~      It is considered a serious injury, because both the strong association with vascular and~     nerve damage, which can lead to the need for limb amputation, such as the difficulty in~     obtaining a good functional outcome even after treatment of all ligament injuries.~      The treatment of these injuries aims to achieve knee stability. Joint mobility is often~     sacrificed in the postoperative period, with the use of immobilizations such as casts,~     splints or bracing. Unfavorable clinical outcomes with high rates of stiffness and joint~     pain are very common in these patients. In attempts to improve these results, rehabilitation~     protocols with early range of motion can be employed. However, results may remain~     unsatisfactory, predominantly because of knee instability recurrence.~      Stannard and Zaffagnini proposed a new model for treatment of acute knee dislocations. In~     this model, after multi-ligament reconstruction or repair, a knee articulated external~     fixator is used. Such external fixator allows early and aggressive joint mobility in the~     sagittal plane only. Flexion and extension are permitted, but rotational movements,~     translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings~     are not allowed. Thus protective stability is ensured for ligament reconstruction~     procedures. Simultaneously the investigators allow immediate joint mobilization, reducing~     the risk of arthrofibrosis, joint stiffness and postoperative ligament laxity.~      There is no consensus regarding the use of hinged external fixator postoperatively in~     multiple ligament reconstruction procedures for treatment of knee dislocations.~      The objective of this study is comparing functional outcomes after ligament reconstruction~     in patients with knee dislocation, with or without the use of hinged external fixator.~   "
58597|NCT02290184|"~     This is a pilot randomized controlled trial intervention to improve lifestyle behaviors~     (physical activity and health diet) for Filipino Americans with type 2 diabetes on~     metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may~     identify effective intervention strategies to significantly reduce risks for heart disease~     risks (i.e., metabolic syndrome) in Filipino Americans.~   "
58598|NCT02290171|"~     The overall aim is to evaluate if a familybased intervention, targeting overweight and obese~     children and their parents, has a long-term positive effect on weight development and health~     of the children. The alternative hypothesis to the zero hypothesis is that the children with~     overweight and obesity who participate in a one-year intervention together with their~     parents, both at completion of the six months intervention and at long term follow up will~     have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The~     behavioral models and educational strategies will be tailored (by age, gender etc.) and~     include both general information and practical learning sessions.~   "
58599|NCT02290158|"~     This study evaluates the effects of a finishing protocol in orthodontic outcomes using~     ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and~     exclusion criteria receive a treatment using a finishing protocol and their scores are~     compare with 40 patients who don't receive a finishing protocol~   "
58600|NCT02290145|"~     The purpose of this study is to To confirm the predictive value of CCD1 for TPF induction in~     cN2 patients with OSCC~   "
58601|NCT02290132|"~     The clinical application and effect of ATG based myeloablative conditioning regimen after~     allogeneic hematopoietic stem cell transplantation in adult patients with aggressive T-cell~     lymphomas.~   "
58602|NCT02290119|"~     The primary objectives of this study are to understand the effects of soft-tissue balancing~     on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty~     and correlate Intra-operative subjective feel with OrthoSensor Outputs~      Secondary objectives are to quantify and observe:~        -  Pain medication use~        -  Swelling~        -  Muscle strength and girth~        -  Gait efficiency~        -  Patient satisfaction~        -  Activity levels, functional return (i.e., back to work, resume normal activities)~        -  Patient perception of a balanced knee~   "
58603|NCT02290106|"~     HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for~     dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the~     lipid-lowering effects of statins are well-known, other metabolic effects, including effects~     on glucose tolerance and ectopic fat distribution, are less completely understood. Recent~     studies have shown that some statins may increase the risk of diabetes. Further, research~     has suggested that statins may have some benefit in nonalcoholic fatty liver disease~     (NAFLD), a condition associated with obesity that includes increased fat in the liver~     (steatosis) and, in some cases, inflammation and hepatocellular damage (steatohepatitis).~     Pitavastatin, approved by the United States Food and Drug Administration (FDA) in 2009, is~     the most recent statin to enter the market. Unlike most statins, pitavastatin is not~     primarily metabolized through cytochrome P450 (CYP450), and thus has reduced potential for~     interactions with other medications that are metabolized by CYP450. Previous studies have~     suggested that pitavastatin may be neutral to glucose homeostasis and may improve hepatic~     lipid. Neither of these effects has been proven definitively, however, and the current~     proposal aims to characterize in detail the effects of pitavastatin on glucose homeostasis,~     hepatic steatosis, and steatohepatitis.~   "
58604|NCT02290093|"~     The success of colonoscopy is closely related to the quality of colonic preparation.~     However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce.~     Split-dosage cathartic bowel preparation are currently suggested, whereas supporting~     evidence is lacking in this particular group of patients. Moreover, patient tolerability is~     a key factor for success of bowel preparation in the aged people.~      The purpose of this study is to compare the bowel cleansing efficacy and patient compliance~     of following bowel preparation methods prior to elective outpatient colonoscopy in the~     elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before~     colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume~     [2L] PEG-3350 containing ascorbic acid solution.~   "
58621|NCT02289872|"~     The aim of the study was to compare time and success rates of TruView PCD video laryngoscope~     and Macintosh laryngoscope for the pediatric emergency intubation with three airway~     scenarios in a standardized manikin model.~   "
58622|NCT02289859|"~     The purpose of this study is to determine whether undermining during cutaneous surgery~     improves scar cosmesis compared to wound closure without undermining.~   "
58623|NCT02289846|"~     The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic~     gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.~   "
58677|NCT02289131|"~     Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse~     as part of clinical care. The purpose of this study is to determine how often tooth brushing~     should occur for adult patients with breathing tubes (mechanical ventilation), balanced with~     equivalence and safety.~   "
58605|NCT02290080|"~     Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital.~     The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but~     in other situations its use is more of a practise and much less based on scientific~     evidence. In particular, oxygen treatment is routinely used in patients with a suspected~     heart attack and variably recommended in guidelines, despite very limited data supporting a~     beneficial effect. Indeed, a few studies even indicate that oxygen treatment might be~     harmful.~      Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of~     choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved~     with primary percutaneous coronary intervention (PCI), the reopening and stenting of the~     blocked vessel, can give rise to further endothelial and myocardial damage, so-called~     reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury)~     involves a wide range of pathological processes. Vascular leakage, activation of cell death~     programs, thrombocytes and white blood cells leading to extended inflammation and formation~     of clots are examples of those effects.~      The role of oxygen treatment on these pathological processes, on the extent of IR-injury and~     the final infarct size in patients with acute myocardial infarctions (AMI) has not~     previously been studied.~      In an ongoing national multicentre, randomized, registry based clinical trial, the~     DETO2X-AMI trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS~     patients is being investigated.~      The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the~     effect of oxygen treatment on biological systems involved in the pathogenesis of reversible~     and irreversible myocardial damage and cell death in ACS.~   "
58606|NCT02290067|"~     The aim of this test is to determine the system accuracy and user performance evaluation of~     three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data~     should cover the whole range of glucose concentration which could usually be expected in~     patients with diabetes mellitus.~   "
58607|NCT02290054|"~     Urinary retention is a common complication of epidural analgesia. Auriculotherapy could~     prevent this complication. This study will be performed among men receiving thoracic~     epidural analgesia after thoracic surgery.~   "
58608|NCT02290041|"~     Clinical trial phase I/II, of test of concept, blind double, and controlled with placebo,~     randomized 2:1 (Treatment: placebo), in which a total of 15 patients will be included~   "
58609|NCT02290028|"~     The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW~     QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads~     in the US.~      Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed~     during a post approval phase (US sites only).~   "
58610|NCT02290015|"~     This trial was a randomized, single-blinded, sham-controlled study, in which the patients~     were blinded to treatment assignment. First, all candidates underwent audiological testing~     of hearing thresholds, tympanometry and stapedius reflex tests. The patients who were~     selected for the study were interviewed to assess and evaluate their condition and then~     underwent a detailed physical examination that included a complete otorhinolaryngologic~     examination and a complete blood test. Then, the subjects were randomized to undergo true or~     sham ACP. Seven days before (baseline) and seven days after twelve acupuncture (ACP)~     sessions (up to six weeks), which were performed twice a week, all participants underwent~     99mTc-ECD SPECT scanning and completed the Portuguese version of the Tinnitus Handicap~     Inventory (THI), the Visual Analogue Scale (VAS), Hamilton Anxiety Scale (HAS) and the Beck~     Depression Inventory (BDI). The purpose of this study was to integrate the neuroscience~     research findings with the clinical research on tinnitus. Thus, a randomized,~     single-blinded, placebo-controlled trial was implemented to investigate the effect of ACP as~     a treatment for tinnitus using ethylcysteine dimer single-photon emission computer~     tomography (99mTc-ECD SPECT).~   "
58611|NCT02290002|"~     The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing~     in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent~     intracytoplasmic sperm injection (ICSI).~   "
58612|NCT02289989|"~     This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment~     prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in~     decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to~     recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration~     for each of the patient is 1 month.~   "
58613|NCT02289976|"~     The purpose of this study is to determine if surgical angiogenesis performed in talar~     avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a~     superior technique compared to core decompression and nonvascularized osseous autografts.~   "
58614|NCT02289963|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable maximally tolerated daily statin therapy with or without other~     lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in~     South Korea and Taiwan in high cardiovascular risk patients with hypercholesterolemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks~          of treatment.~        -  To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo~          B), non high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),~          lipoprotein (a) (Lp [a]), high density lipoprotein cholesterol (HDL-C), triglycerides~          (TGs), and apolipoprotein A-1 (Apo A-1).~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies.~   "
58615|NCT02289950|"~     MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to~     assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in~     subjects with low CA125 platinum sensitive ovarian cancer in first relapse.~   "
58616|NCT02289937|"~     The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous~     femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery.~     The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced~     the postoperative pain without delaying mobilization.~   "
58617|NCT02289924|"~     The main objectives of this non-interventional cohort field study are to evaluate~     effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients~     with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a~     study population of naïve patients~   "
58618|NCT02289911|"~     Training paramedics in new skills via classroom-based teaching has inherent costs and time~     constraints. The investigators sought to evaluate whether web-based didactics result in~     similar knowledge improvement and retention of FAST (Focused Assessment with Sonography for~     Trauma) compared with the traditional method.~   "
72757|NCT02104999|"~     Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive~     Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home~     residents~   "
58624|NCT02289833|"~     This is a Phase 2, multicenter, single-arm, two cohort study designed to evaluate the~     efficacy and safety of trastuzumab emtansine as single-agent in patients with HER2-positive~     locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will be enrolled~     into two separate cohorts, depending on HER2 status: HER2 immunohistochemistry (IHC) 2+ or~     HER2 IHC 3+. Patients in both cohorts will be treated with an intravenous dose of 3.6 mg/kg~     trastuzumab emtansine on Day 1 of 21-day cycles. Patients will remain on study until disease~     progression (as assessed by the investigator), unmanageable toxicity, or study termination~     by the Sponsor.~   "
58625|NCT02289820|"~     The goal of this study is to evaluate the safety, tolerability and immunogenicity of~     ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60~     years or older who are healthy or who have stable, chronic underlying medical conditions.~     This study will also provide preliminary safety and immunogenicity data to support~     concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of~     MEDI7510 at a dose previously assessed in the Phase 1a study.~   "
58626|NCT02289807|"~     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard~     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National~     Comprehensive Cancer Network guideline. However these recommendations were based on the~     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of~     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better~     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent~     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of~     IMRT. hus, we jointly conduct the first non-inferior randomized trial to determine the value~     of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with~     IMRT. Given the results of clinical studies mentioned above, we decide to adopt the~     concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43~   "
58627|NCT02289794|"~     This Phase I multi-center placebo controlled study is conducted in healthy women with a~     history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.~   "
58628|NCT02289781|"~     A randomized, controlled clinical trial is designed to analyze the wear of enamel by~     opposing polished monolithic zirconia crowns and by the polished veneer surfaces of~     metal-ceramic crowns. This single-blind pilot study will involve a total of 30 teeth that~     require full coverage crowns that oppose natural antagonist teeth.~      The objectives of this research are to test the following hypotheses: (1) differences~     between mean wear of antagonist enamel by polished monolithic zirconia crowns and by the~     polished veneer surface of metal-ceramic crowns are statistically significant; (2)~     differences between mean wear of antagonist enamel by opposing polished monolithic zirconia~     crowns and enamel by opposing enamel are statistically significant; and (3) differences~     between mean antagonist wear of enamel by opposing polished veneer surfaces of metal-ceramic~     crowns and enamel by opposing enamel are statistically significant.~   "
58629|NCT02289768|"~     The main purpose of this vehicle-controlled study is to determine the efficacy and safety of~     a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the~     field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected~     area once daily for 12 weeks.~      A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on~     subclinical actinic keratosis lesions in a subset of patients.~   "
58630|NCT02289755|"~     The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate~     excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.~   "
58631|NCT02289742|"~     The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES®~     Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua~     Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.~   "
58632|NCT02289729|"~     Patient reported outcomes (PRO) have become an important endpoint assessed in clinical~     trials. It is important to understand the relationship between medication and patients'~     symptomatology, quality of life and wellbeing. We predict Duodopa will significantly improve~     quality of life and emotional wellbeing compared to baseline in patients with advance~     Parkinson disease (APD) not well controlled with conventional treatment.~   "
58633|NCT02289716|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of~     osteoarthritis of the hip or knee that are not adequately controlled by current pain~     therapy.~   "
58634|NCT02289703|"~     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may~     change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy~     participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per~     minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on~     maintenance hemodialysis (a method used to remove waste material from the blood when the~     kidneys are unable to do so).~   "
58635|NCT02289690|"~     The study seeks to assess the efficacy of veliparib (ABT-888) in combination with~     carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED~     SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of~     origin, with or without the involvement of regional lymph nodes, including ipsilateral and~     contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral~     supraclavicular nodes~   "
58636|NCT02289677|"~     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric~     manikins while performing CPR. In the current study, we compared effectiveness of two~     video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible~     Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation~     with uninterrupted chest compressions using an child manikin.~   "
58637|NCT02289664|"~     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric~     manikins while performing CPR. In the current study, we compared effectiveness of three~     video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with~     and without chest compressions using an child manikin.~   "
64750|NCT02209779|"~     The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in~     Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety~     parameters~   "
58640|NCT02289625|"~     Abstract~      Obstructive sleep apnea syndrome (OSA) is characterized by complete or partial collapse of a~     narrowed pharynx and it's associated with reduction in cerebral blood flow, cardiovascular~     disease, and neuropsychological deficits and reduces survival. In patients with AOS~     structural, metabolic and hypoperfusion cerebral were associated not only with physiological~     functions but also with attention and executive function. There is a higher association~     between apnea hypopnea index and Mini-Mental State Examination in individuals with the exon~     4 of APO E gene, indicating that exon 4 of APO E gene confers an increased risk for~     cognitive decline in individuals with sleep apnea. The analysis of presence and consequences~     of OSA in cerebral structure, inflammation and neurovascular control can permit a better~     investigation of abnormalities in these individuals and implement interventions to reduce~     the risk of development of cognitive and cardiovascular impairment. The non-pharmacological~     intervention through exercise training can represent an important strategy for improvement~     in cerebral alterations, cognition and reduction in sleep apnea index. The purpose of~     present study is investigate the volume and metabolism cerebral, neurovascular control,~     cognition and exon 4 of APO E gene and their~   "
58641|NCT02289612|"~     The purpose of this study is to determine the specific properties of a variety of dietary~     fibres that lead to different postprandial glycemic and satiety responses in individuals at~     risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that~     demonstrate a wide range of properties in a pudding product, and by examining the ability of~     each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion,~     and improve satiety, versus a low fibre control product.~   "
58642|NCT02289599|"~     This study will be a single-center, single dose, randomized, double-blind,~     placebo-controlled study in healthy Japanese male subjects. The study will consist of 2~     parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts~     of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose~     (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In~     Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at~     one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7~     cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg,~     100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized,~     6 subjects to a single dose of E2307 and 2 subjects to placebo.~   "
58643|NCT02289586|"~     To evaluate the effect and safety of noninvasive ventilation assisted interventional~     bronchoscopy for hypoxemia patients with central airway stenosis.~      With the sedation and analgesia, noninvasive ventilation assisted interventional~     bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective,~     carries high satisfaction rate.~   "
58644|NCT02289573|"~     Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute~     exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating~     phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very~     important therapy for those patients,but traditional ventilation modes have some defects, so~     investigators need to find new modes to solve these problems. In this study, the~     investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the~     effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more~     appropriate ventilation mode for AECOPD patients.~   "
58645|NCT02289560|"~     The objective of this prospective, multi site, single-arm study is to capture the efficacy~     of treatment using the ExAblate Transcranial System and to further demonstrate safety in~     medication-refractory tremor in patients with essential tremor (ET).~   "
58646|NCT02289547|"~     XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with~     advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for~     combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative,~     dose-related toxicity. It may therefore be possible to devise capecitabine maintenance~     regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We~     study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by~     maintenance Capecitabine or Observation in the gastric cancer patients of stable disease~     after 6 cycle 1st line of XELOX chemotherapy .~   "
58647|NCT02289521|"~     This study aims to evaluate the effect of stimulation of prefrontal regions on language~     performance (e.g. word translation and picture naming).~      During the language tests, cortical activity will be registered using electroencephalography~     (EEG) which will provide supplementary information about the cerebral processus involved in~     language production and management of two languages in bilingual subjects.~   "
58648|NCT02289508|"~     Objective:~      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for~     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of~     this study are:~        1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output~          (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with~          a compensated heart failure syndrome (cHFS) or acute decompensated heart failure~          syndrome (adHFS)~        2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and~          DO2 correlate with heart failure staging, especially New York Heart Association (NYHA)~          class and American Heart Association (AHA) stage.~        3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time~          interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2~          correlate with ejection fraction.~        4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).~        5. To evaluate the agreement between hemodynamic measurements obtained using the~          Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and~          reference standards as determined by 2 Dimensional echocardiography (2D-echo)~          measurements in groups of haemodynamically stable and unstable adult patients.~      Design:~      This prospective observational cohort study will be conducted in the Prince of Wales~     Hospital in Hong Kong.~      Setting and Subjects:~      Patients will be screened and recruited from adult patients either scheduled for elective~     2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency~     department at the Prince of Wales Hospital.~      Interventions:~      Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to~     assess inter-observer variability, a second, blinded operator will repeated 15% of scans.~   "
58678|NCT02289118|"~     The central goal of this study is to determine and compare the similarities and differences~     in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD),~     Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia~     (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic~     resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If~     cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an~     optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20~     participants, 45-70 years old, with clinical evidence of young onset focal dementia.~   "
58649|NCT02289495|"~     The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose~     escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when~     co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future~     clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept~     study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and~     repeat dose escalation study and will be conducted as two Parts. Part A will evaluate~     GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10~     mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period~     of dosing is to account for the longer terminal phase half-life of GSK2838232 when given~     with RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence~     following review of interim PK and safety data from at least 4 subjects in the preceding~     cohort. Subjects in both parts will have a screening visit within 30 days prior to first~     dose and a follow-up visit 7-14 days after the last dose. Maximum duration of study~     participation will be approximately 7 weeks. Approximately 40 healthy subjects will be~     enrolled, 8 subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or~     placebo.~   "
58650|NCT02289482|"~     This study investigates the safety, tolerability and PKs of GSK2838232 with and without~     Ritonavir, and to evaluate different formulations of GSK2838232 in healthy subjects. This~     study will evaluate higher single and RTV boosted doses to support continued clinical~     development of GSK2838232 at clinically relevant doses, and subsequently in those infected~     with HIV in a dose ranging phase 2 study. The study is conducted in 2 parts: Part A and Part~     B, study Part A and Part B may be conducted in parallel. Approximately 20 healthy subjects~     will be enrolled into the study, 8 in Part A and 12 in Part B. Part A is a double-blind,~     randomized, placebo-controlled, 4-period, single dose escalation design. Subjects will be~     randomized 3:1 to receive GSK2838232 or placebo. Subjects randomized to placebo will receive~     placebo in all four periods. Following completion of Period 2 PK assessments at 96hr~     post-dose, subjects will begin daily dosing of RTV 100mg for a total of 26 days.~      Part B is a randomized, open-label, unbalanced, 3-period, cross-over design; subjects will~     be randomized 1:1 to each sequence. The relative bioavailability of single 100mg doses of~     powder in a bottle (PIB) active pharmaceutical ingredient (API) of GSK2838232 versus PIB~     spray-dried dispersion (SDD) will be assessed. A single dose of GSK2838232 will~     co-administered on the 10th day of RTV dosing; RTV dosing will continue for an additional 4~     days (total of 14 days). Subjects will have a screening visit within 30 days prior to first~     dose and a follow-up visit 7-14 days after the last dose.~   "
58651|NCT02289469|"~     Medication safety is an important concern in hospital Emergency Departments (EDs), which~     provide approximately 136 million patient visits annually in the US. An accurate list of the~     patient's medications is often needed to inform medical decision-making. Moreover, health~     care facilities are required to provide patients with an accurate, reconciled list of their~     medications upon completion of the visit. However, for 37-87% of patients in the ED, errors~     are present in the documented medication list, and patients often leave without an updated~     list of their medications or a good understanding of their self-care instructions. This~     increases the risk of harmful adverse drug events. Health disparity populations, who are~     more likely to seek care in EDs and who more often have difficulty providing a complete~     medication history, are disproportionately affected.~      Health information technology has the potential to improve medication safety in this~     setting. PictureRx is an internet-based platform designed to improve medication management~     in vulnerable populations. It allows users to generate illustrated medication lists in an~     easily-understood, patient-centered format, in either English or Spanish. The investigators~     have developed a process for importing prescription fill data from the Surescripts~     Medication History service, which covers 96% of US pharmacies, into the PictureRx platform.~     The investigators are developing a mobile tablet PC-based medication history platform that~     receives and processes the Surescripts data, as well as prompts verification and additional~     information about the medication regimen.~      This trial will assess the effect of the PictureRx medication history platform on the~     accuracy and efficiency of the medication reconciliation process, as well as patient~     understanding and satisfaction, in hospital Emergency Departments.~   "
58652|NCT02289456|"~     4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by~     nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4~     cycles.~   "
58653|NCT02289443|"~     In this study, the investigators propose a 10-year follow up study of participants in a~     randomized clinical trial to compare the oral health-related quality of life (OHRQoL), as~     well as general and related satisfaction of conventional complete dentures fabricated using~     two different procedures.~   "
58654|NCT02289430|"~     The purpose of this study is to compare the drug interaction of pharmacokinetics of~     rosuvastatin and ezetimibe.~   "
58655|NCT02289417|"~     The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of~     apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with~     active Ulcerative Colitis (UC).~   "
58656|NCT02289404|"~     The purpose of this study is to Evaluate food effect of NVP-1203 in healthy Korean male~     adults.~   "
58657|NCT02289391|"~     The study try to illustrate the possible mechanisms of tending to induce airway spasms and~     the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with~     asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5,~     IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and~     non-asthma patients.~   "
58658|NCT02289378|"~     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly~     docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the~     first-line therapy.~   "
58659|NCT02289365|"~     This trial is designed as a multicenter, double-blinded, randomized, placebo controlled~     study to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute~     radiation-induced dermatitis in breast cancer patients receiving radiotherapy.~   "
58660|NCT02289352|"~     A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to~     Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson~     Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33%~     (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema~     Associated with Rosacea~   "
58661|NCT02289339|"~     The purpose of this registry is to document the everyday practice in our centers with~     minimal invasive treatment of patients with aortic valve disease who were considered~     suitable for transfemoral aortic valve implantation by heart team.~   "
58679|NCT02289105|"~     The overall objective of this project is to assess if an active choice intervention can~     increase advance directive completion rates.~   "
64751|NCT02209766|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884~     following administration of single and multiple doses in healthy male Japanese subjects.~   "
58662|NCT02289326|"~     Purpose~      This study is an 'N-of-one' observational study focusing on individuals with a hereditary~     predisposition to cancer due to a genetic mutation in the TP53 gene. An individual with this~     mutation has a >90% chance of developing many different forms of cancer in their lifetime.~     Since germline TP53 gene mutation carriers are highly susceptible to cancer, cancer~     prevention strategies and early cancer detection strategies are crucial. Unfortunately, the~     current standard of care for monitoring germline TP53 gene mutation carriers for early signs~     of cancer is yearly MRI scans and intermittent blood draws. Villani et al. showed that~     standard monitoring is inadequate and introduced a more sophisticated protocol for early~     cancer detection. We extended the Villani et al. protocol to include a number of markers for~     early detection and are currently vetting their utility, in terms of their inherent~     variability, patient tolerability of frequent interrogation, and ability to show changes~     that might indicate a need for further examination.~      In addition to the markers being collected, important covariate information, such as diet,~     sleep, and activities are being collected (via, e.g., wearable wireless devices) in order to~     take them into account in assessing the levels of the markers at a single data collection~     time or over time. One important aspect of the protocol is to identify changes, rather than~     specific levels, in marker status over time for an individual that might be indicative of~     tumor formation, essentially exploiting the concept of 'personalized thresholds' discussed~     by Drescher et al.~      If any indication of the presence of a cancer, tumorigenic process, or general sign of~     ill-health is observed, the protocol calls for a discussion of the findings among the~     research team, followed by a discussion between the clinical lead on the research team and~     the primary care provider and/or specialists overseeing a participating patient's care,~     possible validation of the assay(s) motivating the discussions, and a decision on how to~     intervene on the part of the primary care provider and/or specialists.~   "
58663|NCT02289313|"~     Approximately one third of the children and adolescents in the United States are either~     overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic~     groups and households with low socioeconomic status and low parental education. The~     Alternative Learning Center (ALC) within Rochester School District 535 provides viable~     educational options for students who are experiencing difficulty in regular educational~     systems. A greater proportion of students at ALC are minorities, qualify for free and~     reduced lunch and receive special education services. These children are likely to have~     unique barriers to physical activity and healthy eating.~      Specific Aims:~      Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors~     related to physical activity and eating in ALC students.~      Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy~     lifestyle.~   "
58664|NCT02289300|"~     The purpose of this study is to determine whether an investigational drug DCB-BO1202 is~     effective and safe in the treatment of liver fibrosis in HBV patients having experienced~     intermediate stage hepatocellular carcinoma (HCC)~   "
58665|NCT02289287|"~     Stroke is defined as a sudden vascular accident that causes brain damage and neurological~     impairment. Literature shows that a stroke has a negative effect on participation.~     Self-Management (SM) is defined as health promotion and education programs used mostly for~     people with chronic diseases, which aim at helping patients to maintain a feeling of~     wellness. The primary aim of this study is to assess the effectiveness of a group-based SM~     program for post-stroke patients in a community setting, and its contribution to improving~     participation, compared to standard care.~   "
58666|NCT02289274|"~     The purpose of this study is to compare the pharmacokinetics of NVP-1203 and~     coadministration of aceclofenac and eperisone HCl SR.~   "
58667|NCT02289261|"~     The purpose of this study is to determine whether dexmedetomidine added to morphine is~     effective in the treatment of chronic cancer pain.~   "
58668|NCT02289248|"~     Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV~     infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.~   "
58669|NCT02289235|"~     The investigators want to evaluate the effects and safety of ginger in treatment of~     nonalcoholic fatty liver disease (NAFLD).~   "
58670|NCT02289222|"~     This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study~     will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The~     experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.~   "
58671|NCT02289209|"~     Eligible participants with locoregional inoperable recurrence or second primary squamous~     cell carcinoma of the head and neck will be treated with reirradiation combined with~     anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).~   "
58672|NCT02289196|"~     Patients with histologically proven malignancy with documented disease control (objective~     response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only~     HLA-A*02 positive patients.~      The primary objective of the trial is to compare safety and tolerability of four different~     doses of Vx-006. The secondary objective is to compare immunogenicity of four different~     doses of the Vx-006.~   "
58673|NCT02289183|"~     The purpose of this study is to explore the clinical application value of modified~     delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.~   "
58674|NCT02289170|"~     The purpose of this study is to verify the efficacy and safety of heating and cooling~     combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).~   "
58675|NCT02289157|"~     The investigators propose a prospective, randomized trial evaluating the use of negative~     pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators~     hypothesize that negative pressure wound therapy will decrease the wound complications in~     these patients. The investigators aim to look at all wound complications such as infection~     and disruption and will be using Prevena incision management system for our NPWT device .~   "
58676|NCT02289144|"~     This is an, open-label, protocol designed to evaluate the activity of targeted therapy in~     anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or~     rearrangements detected in the ALK gene.~      There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or~     metastatic setting. Ceritinib will be administered to the patient until disease progression~     by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial~     for any other reason.~      The primary focus of this arm of the protocol is identifying ceritinib's activity in~     anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations~     identified in their ALK gene by sequencing their tumor samples, or with the established ALK~     abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis~     FISH probe, and patients with tumors positive by this assay will also be considered eligible~     for therapy on the trial.~      Therapeutic Portion:~      ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2~     cycles~      Primary Endpoint: The development of progression; new recurrence or distant metastasis, as~     well as enlargement of an existing metastasis on radiographic imaging.~      Secondary Endpoints:~        1. Overall response rate for patients treated with ceritinib as part of the study.~        2. Death of study participant due to any cause.~   "
58681|NCT02289079|"~     The purpose of the study is to compare pain control after robotic hysterectomy surgery using~     either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis~     plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic~     assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are~     standard of care in these types of surgeries.~   "
58682|NCT02289066|"~     This study examines how periodontal disease affects the complications of diabetes and how~     treatment for periodontal disease affects biomarkers associated with the complications of~     diabetes.~   "
58683|NCT02289053|"~     Conflicting guideline recommendations for screening colonoscopy result due to scant data~     upon which to develop appropriate recommendations. No previous study has compared the~     prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with~     a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average~     risk individuals with no family history of CRC. The purpose of this study is to determine~     the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors~     associated with the presence of advanced adenomas. This data will provide evidence to~     determine appropriate colon cancer screening guidelines in 40-49 year old persons with a~     family history of colon polyps or colorectal cancer.~   "
58684|NCT02289040|"~     Acute kidney injury (AKI) complicates over 50% of cardiac surgical procedures in children~     where it increases morbidity and the use of healthcare resources. The pathogenesis of AKI is~     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is~     no effective treatment. Improving outcomes in patients at risk of AKI has recently been~     defined as a National Health Service priority. The investigators are currently undertaking a~     program of work that is evaluating the role of plasma-derived microvesicles (MV) and MV~     associated microRNAs (miRNA) as diagnostic biomarkers or therapeutic targets in cardiac~     surgery patients at risk of developing AKI. Preliminary results indicate that these~     biomarkers may have clinical utility in adults. An important consideration is whether these~     biomarkers also have utility in children undergoing cardiac surgery. Measurement of MV at~     serial time points in children presents ethical challenges related to conducting clinical~     research in critically ill subjects. It also presents technical challenges related to the~     very small volumes of blood that may be sampled safely from babies and infants undergoing~     surgery. The aim of the study is to provide estimates of the perioperative variance of MV~     concentrations in 24 children undergoing cardiac surgery, as well as the frequency of AKI~     and other adverse events, protocol adherence and recruitment rates. This will assist with~     the design of a subsequent prospective observational study that will consider the role of~     MV/miRNA in children undergoing cardiac surgery.~   "
58685|NCT02289027|"~     The objective of this trial is to assess in healthy adults the safety and reactogenicity of~     a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the~     glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the~     immunogenicity of the candidate vaccine and find the most suitable dose for further~     deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of~     possibly exposed volunteers owning to organisations such as Médecins sans frontières and~     susceptible to be deployed in the outbreak zone (named as possibly exposed volunteers).~     The other volunteers will be adults with no planned travels to the epidemic zone (named as~     not exposed volunteers). The first group will be randomly allocated to two different~     groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single~     injection of 5x10e10 vp). The second group will be randomly allocated to three different~     groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single~     injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will~     be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.~   "
58686|NCT02289014|"~     Many cancer patients experience their illness as substantial psychological burden. About~     half of the cancer patients suffer from severe stress symptoms and around one third of the~     patients fulfill the criteria for a clinically relevant psychological disorder (mainly~     anxiety disorder and/or major depression). Studies show, that a high level of distress in~     cancer patients is associated with more side effects of and a reduced compliance for~     oncological treatment.~      Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides~     the reduction of levels of anxiety, distress and depression, psycho-oncological support~     facilitates dealing with physical complaints and increases quality of life. Yet,~     psycho-oncological support is rarely utilized by male patients and insufficiently accessible~     for many patients (i.a. lack of supply in the respective area, cost issues).~      The internet overcomes some of these barriers, as it can be used independently of time and~     location. Internet-based therapies are therefore a growing field of interest in research and~     there is evidence for treatment efficacy for several psychological disorders. Moreover~     effect sizes of traditional face-to-face and interactive web-based interventions are~     comparable. However, web-based interventions for cancer patients are still scarce. The~     present research project therefore develops a comprehensive stress management program~     accessible for a vast number of cancer patients. The study targets primarily to evaluate the~     feasibility of the program (technical, organizational feasibility, accessibility). In~     addition, the preliminary efficacy of the program will be analyzed in order to adapt future~     programs for specific patient groups.~   "
58687|NCT02289001|"~     Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training~     of undergraduate Nursing students will increase their capacity to work in an~     interdisciplinary team, the investigators will assess whether introducing the SBAR improves~     the students' knowledge of their own role and that of others on the team (medical students),~     strengthens communication between team members, and enhances the quality of the patient~     assessment and interventions demonstrated by the nursing students caring for a critical~     patient (represented by a high-fidelity mannequin, a Human Patient Simulator).~   "
58697|NCT02288871|"~     The purpose of this study is to determine why sutureless aortic bioprostheses apparently~     offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients~     who underwent aortic valve replacement.~      Our approach to address this question is the combination of clinical data with the~     application of specifically validated experimental and computer based analyses to compare~     the performance of these valves under patient-specific conditions.~   "
72758|NCT02104986|"~     The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for~     treatment of extra cranial NSMGCT in children and adolescent.~   "
58688|NCT02288988|"~     True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G)~     junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any~     downward pressure on the stomach, after maximal mobilization of the distal thoracic~     esophagus. It has been demonstrated that TSE is present in 20% of patients undergoing~     routine surgery for gastro-esophageal reflux disease (GERD), and in more than 50% of cases~     of type III-IV hiatal hernia (HH) that are treated surgically. Recent reports have confirmed~     the importance of diagnosing and electively treating TSE to reduce the risk of anatomic~     recurrence after surgery. The surgical techniques currently used for the elective treatment~     of TSE are based on the association of the Collis gastroplasty with an anti-reflux~     funduplication and the hiatoplasty, performed using minimally invasive techniques; the~     mortality, morbidity, and outcomes of these procedures remain subjects of debate. In light~     of the doubtful validity of the surgical results for TSE, some researchers have proposed~     that this condition should not be treated with surgical therapy. In the absence of~     randomized, multicenter studies designed to compare the surgical techniques used to treat~     TSE, the investigators believe that data obtained from a single-center study may be useful~     to the surgical community, provided that such data are based on an objective intra-operative~     diagnosis of TSE and a rigorous follow-up period.~   "
58689|NCT02288975|"~     The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48~     hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as~     monitored by leukocyte activation and inflammatory mediators.~   "
58690|NCT02288962|"~     Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only~     the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near~     future will undergo pituitary surgery. The remaining adenomas are monitored regularly.~     Operation of these large adenomas will rarely remove all tumour tissue, and there is also a~     risk of worsening of pituitary function. Often, adenomas with the highest growth potential~     are operated several times and some also need radiation therapy, providing additional risk~     for pituitary failure (4). Unlike some of the hormone-producing adenomas, there is no~     established pharmacological treatment for NFPAs. However, there are a few non-randomized~     studies suggesting that treatment with dopamine agonists may slow growth, and also induce~     tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the~     treatment of pituitary adenomas secreting prolactin.~      Aim is to study the effect of medical treatment with cabergoline in non-functioning~     pituitary adenomas on the change in tumour volume.~   "
58691|NCT02288949|"~     The American-European Consensus Conference (AECC) and the Berlin definitions of the Acute~     Respiratory Distress Syndrome (ARDS) could be adequate for epidemiologic studies, but it is~     not adequate for inclusion of patients into therapeutic clinical trials. Despite recent~     reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of~     AECC and Berlin definitions of ARDS, it is still a matter of debate whether the assessment~     of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in~     patients with ARDS. The investigators will perform an observational, multicenter,~     prospective audit in a network of intensive care units in Spain and China for validating and~     confirming that the assessment of hypoxemia at 24 hours after ARDS onset is the most~     valuable tool for stratifying and predicting outcome in patients with ARDS.~   "
58692|NCT02288936|"~     Prostate cancer is the most common non-skin tumor diagnosed in men and the second leading~     cause of cancer death in men in Western countries.~      Between 10-20% of patients are diagnosed at metastatic stage and about half of those~     diagnosed in early stages will develop metastases.~      After the clinical benefit of mitoxantrone and the improved survival of 2-3 months provided~     by docetaxel in first line, the second search is driven to look for effective second lines~     treatments. In recent years, there are new drugs for the treatment of prostate cancer,~     revolutionizing the therapeutic sequence and survival.~      Thus, androgen deprivation therapy, treatment of choice, induces an improvement of symptoms~     in approximately 70-80% of patients, but it is limited by the development of mechanisms of~     resistance to androgen deficiency. Docetaxel was the first chemotherapy drug to increase~     survival in patients with metastatic prostate cancer. The second cytotoxic drug approved in~     the second line treatment of metastatic CRPC has been cabazitaxel.~      Enzalutamide improves survival in patients with metastatic CRPC who had progressed to~     chemotherapy and also in patients who had not received chemotherapy.~      To date, there are no biomarkers available that allow us to identify which patients from a~     clinical or molecular view are those that will be able to benefit from the treatment options~     currently available. The presence of the TMPRSS2-ETS rearrangement has been shown to~     correlate with efficacy in clinical practice abiraterone.~      There is scientific and preclinical background that makes one suspect that the molecular~     alteration may influence the same way enzalutamide antiandrogen activity, but it has not~     been determined to date.~      The objective of this study is to determine whether the efficacy and safety of enzalutamide,~     when administered to patients with castration resistant prostate cancer prior to~     administration of docetaxel is influenced by the presence or absence of the fusion gene~     TMPRSS2- ETS.~   "
58693|NCT02288923|"~     Pain after a knee replacement can impair recovery and use of the new knee. Having an~     injection to numb the femoral nerve is known to give good pain relief after the operation~     but may lead to slower mobilisation as it also prevents the patient from moving the knee.~     Recent studies have shown that infiltration of local anaesthetic (LIA) within the new knee~     joint may also give good pain relief. The null hypothesis is that there is no difference in~     primary or secondary outcome measures between femoral nerve block and LIA, as anaesthetic~     techniques for knee replacement.~   "
58694|NCT02288910|"~     This project investigates the feasibility of assessing the relative blood volume of~     carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from~     pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an~     interventional platform.~   "
58695|NCT02288897|"~     This is an international multicenter, open-label, randomized controlled trial (RCT) of~     single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic~     viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1)~     have failed or are not otherwise candidates for targeted therapy and (2) have failed or are~     not otherwise candidates for at least one immune checkpoint inhibitor. Subjects in the~     comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide~     (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and~     standard of care in the Investigator's country or region. Effectiveness will be assessed by~     comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in~     the two study treatment arms.~   "
58696|NCT02288884|"~     The purpose of this study is to determine the effect of a silver containing dressing~     (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean~     section wound complications in obese women (BMI >35).~   "
64945|NCT02207244|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type~     psoriasis (scaly skin rash).~   "
58698|NCT02288858|"~     The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted~     for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement~     compared to a placebo in female subjects with self-perceived thinning hair associated with~     poor diet, stress, hormonal influences, or abnormal menstrual cycles.~      Viviscal is an oral food supplement specifically designed to promote the quality of existing~     hair growth and/or to promote new hair re-growth for women suffering from temporary thinning~     hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been~     marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich~     compound of marine extracts blended with soluble silica and fortified with Vitamin C.~     Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works~     over several months of use to improve the appearance of thinning hair.~   "
58699|NCT02288845|"~     The purpose of this study is to determine the relationship between ITI-007 dose, plasma~     levels and brain receptor occupancy in patients with stable schizophrenia.~   "
58700|NCT02288832|"~     Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries~     have no abnormal history. It is widely agreed that preterm delivery is often associated with~     bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of~     bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the~     Nugent score, but it lacks the characteristics necessary for widespread use in the general~     population. It must be performed on a fresh swab, and any delay in transporting it can cause~     drying that makes the test difficult to perform.~      The investigators have developed a rapid diagnostic tool for bacterial vaginosis using~     molecular biology based on a point of care model and obtained a patent (European Patent~     Office N° 2087134). In comparison with the reference techniques, our tool's performance has~     been excellent, in terms of specificity, sensitivity, and positive and negative predictive~     values. In particular, our work showed that 57% of the flora samples rated as intermediate~     on the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore~     identifies a homogeneous population of women with vaginal flora anomalies. The investigators~     recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL~     shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006).~     Vaginal flora anomalies are therefore an important target for preventing preterm delivery.~   "
58701|NCT02288819|"~     The primary objective of this study is to assess whether the urinary sodium/creatinine or~     chloride/creatinine ratio might predict successful downtitration of loop diuretics in~     patients with stable heart failure without clinical signs of volume overload. In addition,~     this study will provide information on loop diuretic efficiency and urinary electrolyte~     composition after intake of diuretics in stable outpatients with heart failure.~   "
58702|NCT02288793|"~     The study evaluates the knowledge and attitude about Focused Assessment with Sonography in~     Trauma examination among medical students and medical staff in Poland.~   "
58703|NCT02288780|"~     Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign~     prostatic hyperplasia (BPH). Non-conductive irrigation fluid is used to maintain good~     visibility of the operating field during resection of the prostate. Absorption of this~     hypotonic solution into the bloodstream can cause fluid overload and dilutional~     hyponatremia, resulting in adverse cardiovascular and central nervous system effects,~     transurethral resection (TUR) syndrome. BPH is common in elderly men above 60 years old.~     These aged people commonly have diastolic impairment by normal physiologic change without~     consistent symptom. This study aimed to evaluate the cardiac function focused mainly~     diastolic function during TURP with transthoracic echocardiography. Also, we will focus the~     effets of amount of irrgation fluid on left ventricular diastolic function in patients with~     pre-existing diastolic dysfunction.~   "
58704|NCT02288767|"~     During an enterectomy, especially in an open surgery, large amounts of fluid are~     administered in consideration of the patient's fasted state, maintaining blood pressure~     during surgery and potential third space loss. However, it has recently been reported that~     excessive fluid administration during surgery is actually detrimental to patients'~     prognoses. In fact, several reports have suggested that compared to limited fluid~     administration, excessive fluid administration increased the length of stay or the chances~     of complications. Thus, goal-directed fluid optimization is required during surgery because~     only a proper amount of fluid (neither limited nor excessive) administration can minimize~     postoperative complications and enhance prognosis. In general, the amount of fluid~     administered is determined with regard to the patient's volume status, including a~     comprehensive assessment of vital signs such as the pulse rate and blood pressure, and urine~     volume. However, this method has limitations in that it is an inadequate indicator of the~     actual intravascular volume of a patient to determine and administer the proper amount of~     fluid. Recently, new methods of measuring volume status that are less invasive and more~     accurate have been introduced. These methods include stroke volume variation (SVV) that~     monitors changes in arterial pressure waveform amplitudes with regard to breathing patterns.~     This is an effective method of monitoring fluid responsiveness after placing a catheter via~     a radial artery puncture. The stroke output is dependent on the preload, afterload, and~     cardiac contractility. The cardiac output is determined by multiplying the stroke output and~     heart rate. SVV indicates the difference in stroke output within one breathing cycle. A~     direct or indirect measurement of stroke output is required, which can be performed by~     analyzing arterial pressure waveforms via a FloTrac Sensor (Edwards Lifesciences, USA)~     monitor. SVV is known to have a high fluid responsiveness even during open surgeries, yet~     there is practically no research data on its effect in patients' postoperative recovery and~     prognosis in comparison to the traditional methods of fluid administration. Therefore, the~     investigators will apply SVV via a FloTrac/ Vigileo™ monitor on patients undergoing bowel~     resection to determine whether it better assists proper fluid administration compared to the~     traditional method of fluid administration by examining the patients' postoperative~     prognosis such as bowel movement recovery and length of stay.~   "
58705|NCT02288754|"~     The aim of this study is to employ genomic detection methodologies to measure the relative~     amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic~     disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy~     treatment. More generally, this approach will allow us to develop a quantitative measure of~     therapy efficacy via the counting of the relative changes in tumor molecules over the course~     of treatment.~   "
58706|NCT02288741|"~     Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively~     randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1)~     or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be~     randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was~     scheduled for all patients.~   "
58732|NCT02288403|"~     Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a~     protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic~     exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic~     high intensity interval training may lead to greater increases in CF compared with~     continuous moderate-intensity training.~      The main objective of this study is to examine the effects of an aerobic high intensity~     training program versus a continuous moderate intensity training program on CF in men 18 to~     44 years.~   "
58707|NCT02288728|"~     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of~     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons~     all over the world. When compared with the advanced upper third gastric cancer, proximal~     gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric~     cancer located in the upper third of the stomach. However, due to abandon the anti-reflux~     barrier of the digestive system caused by the dissection of the cardia and the lower~     esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as~     well as the reflux esophagitis caused by the traditional esophagostomy permanently influence~     the postoperative quality of life for those patients. Nowadays, relationship between the~     digestive track reconstruction for proximal gastrectomy and the postoperative quality of~     life is still with controversies. Previous study reported the gastric tube anastomosis can~     minimize the reflux related symptoms when compared with traditional esophagogastrostomy.~     There still exited some patients need long-term anti-acid drug to control the reflux~     symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for~     proximal gastrectomy may successfully control the reflux symptoms and there existed study~     found it is as safe as the esophagostomy. But there has no randomized control study to~     compare the postoperative quality of life between the gastric tube anastomosis and~     double-track anastomosis for proximal gastrectomy.~      By the reasons above, a randomized controlled trial is conducted with the intention to~     compare the intraoperative and postoperative mortality and morbidity and the postoperative~     quality of life between the esophagogastrostomy and the double-track anastomosis in the~     proximal gastrectomy for gastric cancer patients.~   "
58708|NCT02288715|"~     The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion~     pressure) is related to sepsis-associated encephalopathy and outcomes of patients with~     sepsis.~   "
58709|NCT02288702|"~     About 1 in every 700 babies born in the United States has Down's Syndrome (DS; Trisomy 21),~     99% of whom have some degree of intellectual disability. Recent advances in medicine have~     resulted in a dramatically improved lifespan of about 25 to 60 years of age. Yet, there is~     limited data about anesthetic management in this increasing patient population. The~     bispectral index (BIS) monitor is a non-invasive monitoring device that reports a value~     between 0 and 100correlating to level of consciousness of an individual. A value of 0~     indicates lack of brain activity while 100 indicates an awake/alert state. This monitor can~     be used to assess the depth of anesthesia. Patients with intellectual disability from~     congenital neurological diseases have lower BIS values compared to patients without any~     neurological impairment (Valkenburg 2009). The results may suggest that DS patients would~     require less anesthetic drugs compared to patients without any neurological impairment. To~     date, there are no studies in DS patients.~   "
58710|NCT02288689|"~     In this study the investigators aim to compare the cervical dilation time in pregnant~     patients at term who had clinical evaluation of the cervical consistency with patients who~     had also quantitative measurement of the cervical elasticity in .~   "
58711|NCT02288676|"~     This study will determine whether a genetic test of Pap samples detects ovarian and~     endometrial cancers.~   "
58712|NCT02288663|"~     Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The~     reference technique to measure GFR (clearance of a glomerular agent) is not commonly used.~     Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several~     published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at~     predicting the endogenous creatinine production by morphological parameters (age, body~     weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is~     quite commonly encountered (frequently linked to Alzheimer disease). This is probably the~     main reason why the aforementioned formulae are not valid in this population: for a given~     renal function, a lower muscular mass induces a lower creatinine production and, henceforth,~     a lower SCr value, which gives an overestimation of eGFR.~      Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by~     whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance~     Spectroscopy (BIS) can also be used.~      Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and~     LBM estimation from DXA. Proof of concept has already been made by others but until now, no~     specific formula for the elderly has been devised and properly validated.~      Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM~     (estimated from DXA) in the elderly. This formula will be elaborated from a first series of~     100 patients and validated on a second series of 100 other patients.~   "
58713|NCT02288650|"~     At the child, the post-operative vomitings (POV) remain the main post-operative complication~     in term of frequency. They also represent the first cause of unforeseen hospitalization in~     day case surgery. The causes of POV are multiple, including in particular the post-operative~     prescription of opioids. The role of the premature refeeding remains discussed.~      Up to the age of 4 years, acute pain is difficult to distinguish from other causes of~     distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in~     post-operative.~      The main objective of this study is to estimate the POV in pediatric day case surgery after~     early refeeding with clear liquids in the recovery room or only in the day case wards (usual~     practice).~      The secondary objectives are to estimate the time on returning to the day case ward, at~     home, the post-operative opioid consumption, early refeeding adverse effects (desaturation,~     swallowing trouble)~   "
58714|NCT02288637|"~     The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes~     region in Tanzania comparing the relative effectiveness of 4 vector control interventions~     for reducing malaria transmission and controlling vector populations in an area where An~     gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal~     net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long~     lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid~     LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with~     the LLIN which incorporates a PBO synergist.~      The trial will provide epidemiological, entomological, economic and social evidence of~     impact, as the investigators shall be measuring the reductions in malaria prevalence and~     malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species~     ratios and economic cost effectiveness. The proposed trial will demonstrate whether the~     novel LLIN and long lasting IRS formulation will be more effective for controlling~     An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional~     LLIN. There is great interest in conducting this trial. Alternative vector control products~     are limited and most new insecticides are not suitable for use on LLINs or as IRS.~   "
58715|NCT02288624|"~     This is a human dietary intervention study that is randomized and crossover in design with 4~     treatment arms consisting of control, orange juice,whole orange, and processed whole orange~     to investigate the satiety effects of the treatments in healthy volunteers. Self reported~     hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different~     time points prior to and post consumption of each treatment.~   "
58716|NCT02288611|"~     This aim of this study is to investigate the prebiotic potential of date fruits in healthy~     human volunteers compared to a control diet. Each arm was 21 days in duration, separated by~     a 14 days washout period. Faecal samples, and blood samples will be collected from each~     volunteer and high resolution analytical techniques (HPLC, LC-MS and NMR) will be employed~     to characterise the whole system metabolic response to ingestion of date fruits compared to~     the control. Changes in microbial parameters and metabolite profiles will be correlated with~     changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular~     reactions, blood lipids and bowel movements.~   "
58717|NCT02288598|"~     This study aims to test whether the addition of transcranial direct current stimulation~     (TDCS) to speech fluency training results in improvements in speech fluency in adults with~     developmental stuttering. Half of the participants will receive anodal TDCS on five~     consecutive days, the other half will receive a sham stimulation for the same amount of~     time.~   "
58718|NCT02288585|"~     Double-blind, randomised, placebo-controlled, parallel group study with two intervention~     arms. The study will be conducted in 150 subjects and the primary objective is to show a~     fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with~     established type 2 diabetes mellitus and subjects at high risk of developing type 2~     diabetes.~   "
58719|NCT02288572|"~     The metabolic syndrome is increasing worldwide, including developing countries. The~     metabolic syndrome is composed of clinical expressed symptoms as central obesity, high blood~     pressure, raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum~     triglycerides. All those components together or independently contribute to the development~     of cardiovascular diseases, which are the leading cause of death in the modern world. The~     results from previous studies have shown that probiotic bacteria have an influence on health~     improvement, and can exert positive effects on diseases as diabetes, high blood pressure,~     dyslipidemia and low-grade inflammation, which are all components of the metabolic syndrome.~     The objectives of this study were to investigate which of probiotic strains Lactobacillus~     plantarum PCS 20, Lactobacillus plantarum PCS 26 in Lactobacillus rhamnosus GG exert~     positive effects in the cascade of molecular reactions at the level of small intestines, at~     remodeling of monocytes/macrophages and adipocytes in human cell model of non-cancerous~     origin, and to provide scientific explanation of mechanisms of possible multi-leveled~     activity of selected probiotic strains in patients with metabolic syndrome. For this~     purpose, the investigators divided this research into two parts. The first part consisted of~     pre-clinical in-vitro laboratory study. It examined the mechanisms of actions of probiotic~     cultures with the use of functional cell models of non-cancerous origin, more specifically,~     with the use of cell lines of human intestinal epithelium, human monocytes/macrophages and~     human visceral preadipocytes. In in-vitro laboratory study, the investigators demonstrated~     that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects, which could~     help to relieve the particular components of the syndrome in the host with metabolic~     syndrome. The second part of the research consisted of prospective, double-blind and~     placebo-controlled in-vivo pilot clinical study, which included 16 volunteers with the~     metabolic syndrome. Results have shown that probiotic strain Lactobacillus plantarum PCS 26~     exerts positive effects on reduction of waist circumference, on lowering of serum~     cholesterol concentration, and on maintenance of serum adiponectin levels. Those effects~     together can contribute to the alleviation of the metabolic syndrome, especially in terms of~     clinical manifestation and risks in relation to cardiovascular diseases.~   "
58720|NCT02288559|"~     This multicenter, randomized, single-masked, sham injection-controlled study will~     investigate the exposure-response and safety of lampalizumab administered intravitreally~     every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic~     atrophy (GA) secondary to age-related macular degeneration (AMD). The anticipated time on~     study treatment is 24 weeks. The target sample size is approximately 90 participants.~   "
58721|NCT02288546|"~     This research concerns nutritional and toxicological health risk evaluation among long-term~     vegans. Research focus is in cumulative exposure to pesticides.~   "
58722|NCT02288533|"~     Chronic consciousness disorders have high level of impact on public health and its costs.~   "
58723|NCT02288520|"~     This is a longitudinal, observational, prospective, multicentre study conducted in~     metropolitan France, among a representative sample of office-based or mixed practice~     rheumatology doctors.~      The aim of this study is to describe in real life, the therapy strategy when faced with a~     patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and~     the impact on the progression of the disease at 6 months.~   "
58724|NCT02288507|"~     This study evaluates the safety and efficacy of administering sorafenib concurrent with~     yttrium-90 radioembolization to patients with advanced hepatocellular cancer.~   "
58725|NCT02288494|"~     The primary purpose was to describe the acid base balance of ICU patients with severe~     hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human~     albumin perfusion.~   "
58726|NCT02288481|"~     The objective of this study is to evaluate the safety and tolerability of single oral doses~     of TBA‐354 when administered to healthy adult subjects.~   "
58727|NCT02288468|"~     Randomised, active controlled, double blinded (patient and observer blinded), monocentric~     trial with three treatments, three periods and six treatment sequences allocated according~     to a Williams design~   "
58728|NCT02288455|"~     The purpose of this investigation is to demonstrate the safety and efficacy of the GTU~     artificial urinary sphincter device in restoring continence in males who have confirmed~     urinary stress incontinence for a minimum of 12 months with primary etiology being radical~     prostatectomy or transurethral resection of the prostate (TURP).~   "
58729|NCT02288442|"~     The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle~     training + aerobic training + muscle resistance training) on muscle power, VO2peak and~     gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional~     capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with~     pulmonary artery hypertension.~   "
58730|NCT02288429|"~     Colistin is a polymixin antibiotic used in the treatment of multidrug-resistant~     gram-negative infections. Given the limited use of colistin and previous challenges with~     laboratory assays to determine plasma concentrations, there is a lack of knowledge of the~     pharmacokinetic profile of colistin. The purpose of the investigators observational~     prospective pharmacokinetic cohort study is to examine the steady-state pharmacokinetic and~     pharmacodynamic properties of intravenous colistimethate sodium in cystic fibrosis and~     critically ill patients.~   "
58731|NCT02288416|"~     This pilot trial studies a video-based intervention in reducing anxiety in patients~     undergoing lung cancer screening. Giving a video-based intervention to patients prior to~     lung cancer screening may reduce anxiety and improve the well-being and quality of life.~   "
58733|NCT02288390|"~     Dental plaque score calculation and swabs of Oropharynx and teeth were collected on~     admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12%~     Chlorhexidine/ toothbrush were used 4 hourly~   "
64946|NCT02207231|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type~     psoriasis.~   "
58735|NCT02288364|"~     The purpose of this study is to determine the benefit, if any, of buffering lidocaine~     (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast~     needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies,~     lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It~     is possible that this pain is caused because lidocaine is acidic. Some physicians believe~     that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the~     initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and~     injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care~     by radiologists today. The purpose of this study is to determine if either approach is more~     comfortable for patients having breast procedures.~   "
58736|NCT02288351|"~     The purpose of this study is to investigate small intestinal remodeling and reprogramming of~     glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic~     Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein~     expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major~     mechanism for the remission of T2DM following RYGB.~      The two aims of the study are: 1) to demonstrate that the basement membrane glucose~     transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate~     that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control~     observed in T2DM patients undergoing RYGB.~   "
58737|NCT02288338|"~     A randomized open-label, multiple dose, three-treatment, three-period, six-sequence,~     crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and~     Ezetimibe after oral administration in healthy volunteers~   "
58738|NCT02288325|"~     This study evaluates the efficacy, safety and tolerability of levomilnacipran~     extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).~   "
58739|NCT02288312|"~     Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period,~     3-sequence study in 18 healthy male and female subjects.~   "
58740|NCT02288299|"~     The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance~     in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will~     be assessed in a prospective, randomized, cross over, open label study~   "
58741|NCT02288286|"~     The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried~     rabies vaccine (MRC-5 cells)in different age health human populations, according to the~     traditional Essen methods (1-1-1-1-1) vaccination.~   "
58742|NCT02288273|"~     A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared~     with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.~   "
58743|NCT02288260|"~     This NIS is a multi-centre, observational, descriptive, cross-sectional study including all~     consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective,~     longitudinal cohort study which will include patients hospitalized for ACS and who are with~     ticagrelor on discharge from hospital.~   "
58744|NCT02288247|"~     The purpose of the study is to understand if there is benefit in continued treatment with a~     medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a~     standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when~     treated with enzalutamide alone.~   "
58745|NCT02288234|"~     The telavancin observational use registry (TOUR) will collect data to support study of the~     efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in~     outpatients being treated in infusion centers who are receiving clinician directed~     telavancin therapy.~   "
58746|NCT02288221|"~     All over the world the increasing prevalence of chronic disorders and its impact on~     functional decline is challenging the sustainability of health care systems. Older~     individuals also frequently experience the reversible frailty syndrome, which overlaps~     with chronic diseases, increasing incidence of disability.~      Building a global system aiming to take in charge all causes leading to loss of autonomy is~     a rather complicated task involving numerous Information and Communication technologies~     (ICT) solutions which are not always easy to use in everyday life.~      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality~     of life of older people at risk.~      The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation~     aromatherapy automatic fragrance, training interface based on Kinect sensor...) .~      The goal of this study is to validate the acceptability, sensitivity and efficacy of the~     systems.~   "
58747|NCT02288208|"~     This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are~     currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will~     receive either birinapant or placebo in addition to their anti-viral therapy.~   "
58748|NCT02288195|"~     Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced~     rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term~     toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could~     improve overall survival. The purpose of this study is to compare the effects of~     chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin~     ) and selective use of the standard treatment to the standard treatment of chemotherapy and~     radiation.~   "
58749|NCT02288182|"~     A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™~     compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of~     Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed~     bone to residual bone substitute.~   "
58799|NCT02287532|"~     The aim of the TELESAGE study is to demonstrate~        1. the superiority of follow up with the DIABEO system (software alone) versus usual~          follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated~          with a basal-bolus insulin regimen.~        2. the superiority of follow up with the DIABEO system (software + telemonitoring)~          compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2~          patients treated with a basal-bolus insulin regimen.~      The DIABEO software alone is an electronic diary system incorporating an immediate automatic~     aid to calculating the insulin dose according to the prescription given by the doctor, and a~     data processing, automated analysis message and secure internet data transfer system.~      The DIABEO software added by paramedical telemonitoring is the electronic diary combined~     with remote paramedical monitoring of data (telemeonitoring)~   "
58750|NCT02288169|"~     Regardless of their treatment, cancer patients endure a variety of difficult symptoms during~     their disease with averages ranging from 7 to 14 symptoms each. Cancer-related symptoms,~     especially when symptoms are very intense, distressing, frequent, or interfere with daily~     activities, can lead to depression, anxiety, and diminished quality of life. Improving their~     ability to self-manage difficult symptoms has the potential to diminish suffering, improve~     quality of life and decrease emergency room visits and associated costs. The investigators~     propose to test a brief, effective intervention with outpatients in a cancer center, with~     the goal of teaching patients symptom management skills for self-identified symptoms of~     highest priority to patients. Objective: The proposed randomized clinical trial will test~     the efficacy of the COPE intervention with patients with symptoms of moderate to high~     intensity, distress, frequency or interference with their lives as a result of their cancer.~     Method: The investigators will seek 300 completed subjects, outpatients with breast,~     colorectal, lung, and prostate cancers. Patients will be randomized into three groups. Group~     III, the experimental group, will receive usual care plus the COPE intervention. This group~     will receive 3 individual intervention sessions. During the first intervention visit at the~     cancer center, the COPE group will be taught the COPE intervention in a session focusing on~     the patient's self-identified most bothersome symptom. Role modeling and additional~     instruction will be provided via video, and patients will receive the Home Care Guide for~     Cancer and a copy of the video to take home. Three subsequent visits with the patient during~     regularly scheduled clinic visits will reinforce the principles of COPE and the use of the~     Home Care Guide, and will help patients apply this approach to managing other symptoms. In~     addition they will get 2 phone calls encouraging them to apply COPE. Group II, the attention~     control group, will receive supportive visits from the research team at the cancer center~     and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls,~     matched for time with COPE participants. Group I, the control group receiving usual care,~     will receive no additional attention from our interventionists. Data will be collected~     weekly for 9 weeks about symptoms (intensity, frequency, interference, appraisal of~     distress), self-efficacy, and barriers to self-management. Patient Outcomes: Quality of~     life, anxiety and depression will be assessed at baseline and weeks 4, 8, and 12. The~     investigators predict that the COPE group will show significant improvement in depression,~     anxiety, quality of life, symptom intensity, distress, frequency and interference,~     self-efficacy, and perceived barriers to care, as well as decreased utilization of health~     care resources compared with the two control groups. Data will be analyzed using repeated~     measures multivariate analysis of variance using a mixed model approach.~   "
58751|NCT02288156|"~     Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is~     estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic~     inflammation of the inner lining of the nose and is characterized by the following symptoms:~     rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining~     rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than~     twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the~     knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and~     non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic~     rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin~     nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM~     (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal~     spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in~     VAS for major nasal symptom on week 4.~      (Estimated placebo effect is 25%.)~   "
58752|NCT02288143|"~     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled~     ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of~     oocytes retrieved.~   "
58753|NCT02288130|"~     Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy,~     because of the many benefits for the patient in terms of pain, hospital stay and recovery.~     In order to increase the success rate of a laparoscopic procedure pre-treatment to decrease~     the volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for~     this purpose with good results in terms of volume reduction, but sometimes resulting in loss~     of distinction of the right surgical planes. Ulipristal is a new pre-operative treatment~     option for symptomatic fibroids, which has demonstrated good results in terms of volume~     reduction. The effect on cleavage planes is unknown. This study is performed to evaluate if~     Ulipristal is as effective as GnRHa in terms of surgical outcome.~      Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative~     blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life~     and costs.~      Study design: Double blind randomized controlled multi-center trial. Study population:~     Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12~     cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.~      Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline~     injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison)~     11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once~     daily) .~      Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy~     by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up~     will be 6 months after surgery mainly for quality of life assessment. A cost utility~     analysis will be conducted alongside the trial.~      Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss~     during surgery when the average difference between the two groups is below 150 ml (standard~     deviation 250 ml).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has~     been tested and no specific risks apply.~   "
58754|NCT02288117|"~     The objective of this PMCF is to collect clinical and radiographic outcome information on~     Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine~     conditions.~      The results collected will be used to clinically confirm the performance and safety of the~     LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a~     PMCF. Furthermore the results can be used for future regulatory processes if needed.~   "
58755|NCT02288104|"~     This study is a prospective study in order to demonstrate the technical feasibility and~     safety of doing endomicroscopic imaging during interventional radiology procedure in two~     main indications: Kidneys and liver.~      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The~     proposed study is a feasibility study.~   "
58756|NCT02288091|"~     This is a single center, open label, 12-week study of inosine treatment. Inosine treatment~     leads to an increase in the levels of urate (uric acid) in the blood.~      The primary objective of the study is to determine the safety and tolerability of oral~     administration of inosine.~      Secondary study objectives include the measurement of biomarkers of oxidative stress and~     damage in response to inosine treatment.~   "
58757|NCT02288078|"~     The objective of this randomized placebo-controlled Phase 2 study is to evaluate~     prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise)~     resulting from regorafenib treatment, as well as to assess treatment continuation of~     regorafenib.~   "
58758|NCT02288065|"~     Retrospective survey for factors predicting the outcome of medical thoracoscopy~   "
58800|NCT02287519|"~     This research study is evaluating an educational intervention for women who have experienced~     changes in sexual function after treatment for ovarian cancer.~   "
58829|NCT02287142|"~     The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block,~     suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder~     arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all~     three arms will receive equal analgesia since these blocks are routinely performed to treat~     post-operative pain after shoulder surgery.~   "
59188|NCT02282488|"~     A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low~     protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as~     reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.~   "
58759|NCT02288052|"~     The basal ganglia play an important role in motor learning, especially during the~     consolidation phase of motor learning. This raises the question whether it is possible to~     sustain learning increments in a neurodegenerative condition such as Parkinson's disease~     (PD). The aim of this study is to gain knowledge on whether it is possible to relearn skills~     which are actually affected by PD, such as writing, and determine whether neuroplasticity is~     possible. In this randomized controlled study, PD patients will either follow intensive~     writing training or a placebo treatment (stretch and relaxation training) during 6 weeks.~     The writing training will focus on automatization (withstanding dual task interference),~     transfer to an untrained task and retention. The placebo program is aimed to reduce~     stiffness in the upper limbs and has been shown to be ineffective in PD. To date, it is~     unknown how neural networks change as a result of consolidation after a prolonged period of~     motor learning in PD. Therefore the second arm of this study will investigate, for the first~     time, changes in neural connectivity using brain imaging data to elucidate which~     neuroanatomical regions are involved in consolidation of learning in PD. Finally, DTI and~     resting state fMRI-analysis will complement insights into the neural changes as a result of~     learning.~   "
58760|NCT02288039|"~     The main aim of pulmonary rehabilitation is to improve the quality of life of patients that~     have been diagnosed with chronic lung disease. The challenge for pulmonary rehabilitation is~     that many patients do not complete their agreed or prescribed training targets which may be~     related to the way pulmonary rehabilitation is delivered. There is a belief among doctors~     and other healthcare professionals delivering pulmonary rehabilitation care that patients~     who are working together as part of a group may better accomplish their agreed training~     targets (intervention). The intervention aims to encourage members of the group to interact~     and support each other during the rehabilitation sessions in order to attain agreed~     pulmonary rehabilitation goals~   "
58761|NCT02288026|"~     The purpose of this study is to compare early-stage peripheral non-small cell lung cancer~     lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and~     effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung~     cancer as lobectomy.~   "
58762|NCT02288013|"~     Comparative study of the surgical outcome of 2-layers closure technique of uterine incision~     in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture~     material (Vicryl) regarding the time of closure and the need of secondary additional~     suturing or tearing of uterine muscles during suturing.~   "
58763|NCT02288000|"~     The early assessment of new drugs for Alzheimer's disease remains difficult because of the~     lack of predictive end-point. The use of a battery including different parameters could~     improve this early development of new drugs. Nevertheless, the interest of such a battery~     should previously be validated with the yet marketed AD drugs.~   "
58764|NCT02287987|"~     Prospective, randomized trial comparing surgical, functional and oncological outcomes~     between clamp and clamp-less robot assisted partial nephrectomy.~   "
58765|NCT02287974|"~     To study the effect of the stem cells therapy autologous mononuclear from the bone marrow,~     autologous progenitor endothelial CD133 cells from the bone marrow and autologous~     mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to~     insulin and the decrease of the needs of insulin, besides evaluates the safety, viability~     and efficiency of the intra-arterial infusion of stem cells in diabetic patients type 2 with~     CLI.~   "
58766|NCT02287961|"~     Multicentric epidemiological non-comparative study in France characterising evolution of~     anal Human papillomavirus (HPV) infection and related lesions and evaluating markers~     associated with the observed evolution.~      Estimated enrolment: 500~      Principal Outcomes~        -  Detection of high-grade cytological and histological anal lesions by high resolution~          anoscopy~        -  Spontaneous regression of high-grade anal lesions~        -  Detection of anal HPV infection~      Intervention (procedure):~        -  Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up~          visits and if applicable Month 6 and Month 18 control visits)~        -  Standard proctologic examination with digital rectal examination and 2 anal swabs~          (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable~          Month 6 and Month 18 control visits)~        -  High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up~          visits and if applicable Month 6 and Month 18 control visits)~      Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High~     Resolution Anoscopy (HRA):~      - anal biopsy(ies) during HRA~      Only if high-grade lesion:~      - HRA biannually~   "
58767|NCT02287948|"~     Balance disorders are frequently observed in patients with Multiple Sclerosis (MS) and the~     deterioration of the static and dynamic control of balance is an important and basic symptom~     of disease progression.~      Measure balance disorders with force platforme requires personnel and represent a~     significant cost.~      The platform Nintendo Wii Fit represents a valid economic alternative~   "
58768|NCT02287935|"~     It was investigated whether there is a factor that can aid determination of the preferred~     technique by comparing the early Limberg flap and Karydakis procedure techniques for the~     treatment of recurrent pilonidal sinus.~   "
58769|NCT02287922|"~     The primary objective of this study is:~      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered~     subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).~      The secondary objectives of this study are:~        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),~          pharmacodynamics (PD), and immunogenicity of ALX 0061 and to explore potential dose~          regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical~          development.~        -  To obtain parallel descriptive information concerning the efficacy and safety of~          tocilizumab (TCZ) s.c. in the same clinical trial RA population.~   "
58811|NCT02287376|"~     Study Objectives:~        1. The primary objective is to characterize the pharmacokinetics of a single oral~          administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis~          of episodic migraine with or without aura.~        2. The secondary objectives are to determine:~             1. The safety and tolerability of Cambia from a single dose~             2. Three-month safety evaluation of Cambia in outpatient usage in this population~   "
62799|NCT02235259|"~     The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic~     Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a~     4 week Three Times a Day (TID) treatment period~   "
58770|NCT02287909|"~     The recommended antiplatelet treatment regimen for patients affected by acute coronary~     syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in~     the combination of aspirin and a P2Y12 receptor inhibitor. More potent P2Y12 receptor~     inhibitors, such as ticagrelor, have been developed which are associated with less response~     variability than clopidogrel and better clinical outcomes. Ticagrelor use has increased~     significantly because of its more expanded Food and Drug Administration (FDA) indications~     compared with prasugrel. However, despite the evidence for sustained efficacy and safety,~     many physicians limit treatment duration with ticagrelor to the early phases following an~     ACS mostly due to cost issues and concerns about increased bleeding. Therefore, it is very~     common in clinical practice to switch patients while on maintenance dosing (MD) with~     ticagrelor to treatment with clopidogrel. However, the pharmacodynamic (PD) effects of~     switching from ticagrelor to clopidogrel remain unknown. Therefore, the aim of this~     investigation is to evaluate the PD effects of switching from ticagrelor to clopidogrel.~   "
58771|NCT02287896|"~     The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in~     RhDnegative pregnant women carrying an RhD-positive foetus.~      And to assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive~     foetus and newborns.~      In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in~     RhDnegative pregnant women carrying an RhD-positive foetus and the immunogenicity of~     Roledumab will be assessed.~   "
58772|NCT02287883|"~     The investigators will study the delivery of care to patients with diabetes and~     cardiovascular diseases from 16 practices in health care organizations who receive~     incentives for improving the quality of patient care. Half of those will be far along in~     engaging patients in their care and half will not. The investigators will see whether~     patients with diabetes or cardiovascular diseases who receive care from practices that more~     fully involve their patients have better clinical outcomes and satisfaction with their care~     than those who do not. The investigators expect that these findings will help practices and~     patients to achieve better outcomes of care.~   "
58773|NCT02287870|"~     Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a~     short time, provides fast motor recovery and causes no significant side effects.~   "
58774|NCT02287857|"~     The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir~     Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir~     Disoproxil Fumarate Tablets of Gilead.~   "
58775|NCT02287844|"~     The purpose of the present study was to establish the prebiotic effect of a new~     xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine~     their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this~     randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were~     randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS)~     or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.~   "
58776|NCT02287831|"~     The purpose of this study is to assess the safety and efficacy of umbilical cord mesenchymal~     stem cells in diabetes with peripheral arterial disease.~   "
58777|NCT02287818|"~     AC-201CR is a control released formulation of AC-201 that in previous clinical studies~     showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The~     mechanism of actions of AC-201 include the inhibition of the production and activity of~     caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters~     in kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations~     below the urate solubility limit while avoiding acute gout flares. However, the initiation~     of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares.~     IL-1β plays a key role in mediating this inflammatory response. The study is designed to~     test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing~     period, followed by addition of an ULT to test the efficacy and safety of the combination~     and prophylaxis of gout flares during ULT.~   "
58778|NCT02287805|"~     The purposes of this study are:~        -  to better understand the experience of the announcement for the diagnostic of~          craniosynostosis to patients and their families to improve the understanding of it and~          it modes of appropriation~        -  to compare the announcement process concerning simple and complex forms.~        -  to identify the intra-family issues at the announcement of a genetic mutation.~        -  to reconstruct the care course of patients by analyzing the time of the announcement~          and the post-operative period.~   "
58779|NCT02287792|"~     The purpose of this study is to assess the impact of 18-FDG positron emission tomography~     (PET)/computed tomography (CT) imaging in the managment of patients with suspected or proven~     IE in detecting cardiac valve damages and other extracardiac complications. The study will~     evaluate whether this procedure can change the clinical decisions (treatments, valve~     surgery, patients' overall care) and modify the diagnosis of IE.~   "
58780|NCT02287779|"~     This study will investigate the safety and tolerability of daily dosing regimens of SHP626~     in overweight and obese adults.~   "
58781|NCT02287766|"~     The objective of this study is to determine whether the finger tip images captured by the~     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale~     that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.~   "
58782|NCT02287753|"~     The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during~     cardiac surgery to predict postoperative outcomes in pediatric patients.~   "
58783|NCT02287740|"~     Objective: To conduct a comparative efficacy and cost-effectiveness study of an~     evidence-based fall prevention program—Tai Ji Quan: Moving for Better Balance (TJQMBB).~   "
58784|NCT02287727|"~     This phase II trial studies how well regorafenib works in reducing the return of disease in~     patients with rectal cancer that has not spread to another place in the body who have~     completed curative-intent treatment. Regorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Regorafenib may also help keep cancer~     from coming back after it has disappeared following the initial therapy.~   "
58785|NCT02287714|"~     Compare results of Instep Plantar Fascial release with and without gastrocnemius recession~   "
58786|NCT02287701|"~     The overarching goal of this project is to explore whether associations exist between~     metrics obtained from PET/MRI incorporating advanced MRI sequences and features of bladder~     cancer, including grade, stage, and treatment response.~   "
58787|NCT02287688|"~     This safety surveillance study of Novartis quadrivalent meningococcal ACWY conjugate vaccine~     (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a~     post-marketing study required by the United States Food and Drug Administration.~      It is an observational study of children 2-23 months of age who receive at least one dose of~     MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while~     enrolled as a KPSC health plan member.~      The objective of the infant study is to describe medical events that require emergency room~     visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23~     months of age in a health maintenance organization in the United States. Outcomes include~     medical events that require emergency room visits or hospitalizations in children 2-23~     months of age following any dose of MenACWY-CRM vaccination. Events with a history of the~     same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a~     pre-existing condition.~   "
58788|NCT02287675|"~     To compare the kinetics and efficacy of two functionally different diagnostic agents,~     Lymphoseek (CD206 receptor targeted) and 99mTc-SC (Sulfur Colloid non-specific mapping~     agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).~   "
58789|NCT02287662|"~     The primary objective of this trial is to provide a rigorous assessment of the efficacy,~     feasibility and safety of the Vancouver 3M Clinical Pathway protocol in patients undergoing~     elective transfemoral TAVR with balloon expandable valves.~   "
58790|NCT02287649|"~     Aims of the study : 1) To determine whether the presence of the V158 allele of Fc gammaRIIIA~     gene is associated with a better outcome of Immune Thrombocytopenia (ITP) in adults and~     especially with a higher response-rate to rituximab. 2) To analyze the impact of therapy and~     especially rituximab on some B and T cells autoreactive subsets in the peripheral blood.~      Patients and Methods :~      Inclusion criteria : age ≥ 18 years, primary ITP defined according to the recent consensual~     criteria (Rodeghiero F et al. Blood 2009), active ITP defined as an ITP with a platelet~     count < 50 x 109/L requiring treatment, informed consent. Main exclusion criteria :~     secondary ITP.~      Blood samples (serum, plasma, DNA) will be collected in every patient at time of inclusion~     (pre-treatment) and then sequentially at 3, 6 and 12 months after inclusion in patients~     treated with rituximab or during the remission phase for other treatments for immunological~     studies. When a marrow analysis is indicated, some marrow specimens will also be collected~     and studied and if a patient will have to undergo a splenectomy as a standard of care, some~     spleen specimens will also be collected. Fc gamma RIIIA V/F158 polymorphism will be assessed~     by means of an allele-specific PCR. The sequential analysis of anti-platelets~     (anti-GpIIbIIIa) antibodies producing B cells will be performed by means of flow cytometry~     and ELISPOT analysis. T cells subsets will be harvested in presence of GpIIbIIIa~     immunodominant peptides and and cytokines expression will be measured on supernatants on~     days 2 and 11 in vitro by using Luminex technology in order to characterize and distinguish~     TH1, TH2, TH17, TFH and Tregs subsets.~      The primary outcome will be the overall response rate 1 year after inclusion defined by a~     platelet count > 30 x 109/L with at least a two-fold increase of the initial (pre-treatment)~     count. For the patients treated with rituximab as a standard of care, based on the overall~     expected response-rate (40-50%) and based on preliminary data on FcgammaRIIIA V/F158~     distribution, the inclusion of 85 patients should be sufficient to show an association of~     the V158 allele and the response (b risk 20% and a 5%). Responders and non responders will~     be compared by non parametrical tests, a multivariate analysis will be than performed using~     a logistic regression model. The immunological data B and T cells subsets) obtained in both~     the responders and the non responders will be compared over time (To, M3, M6 and M12) by non~     parametrical matched tests.~   "
58791|NCT02287636|"~     This pilot clinical trial studies how well positron emission tomography (PET)/magnetic~     resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger~     patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET~     scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the~     same time with the same machine. The combined scans give more detailed pictures of areas~     inside the body than either scan gives by itself. It is not yet known whether PET/MRI works~     better than PET/CT in diagnosing younger patients with cancer.~   "
58792|NCT02287623|"~     The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,~     provides improved pain control and decreased opioid use compared to bupivacaine when~     injected during a transversus abdominis plane block for donor nephrectomy patients.~   "
58793|NCT02287610|"~     The overall objective of the study is to assess the effectiveness of switching from~     immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in~     patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to~     standard of care in clinical practice settings.~   "
58794|NCT02287597|"~     This local, non-interventional, cohort study of patients with metastatic colorectal cancer~     (mCRC) will prospectively collect data from standard clinical practice of second-line~     treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional~     diagnostic or therapeutic procedures required by this study, apart from those performed in~     everyday clinical practice for second-line treatment of mCRC in Croatia.~   "
58795|NCT02287584|"~     The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with~     placebo in patients with schizophrenia.~   "
58796|NCT02287571|"~     The aim of this prospective, randomized controlled trial is to compare the effects of~     preoperative skin traction and position splint on pain, comfort, complications, difficulty~     level of nursing interventions, satisfaction from treatment and nursing care in patients~     with hip fracture. The sample is comprised of 34 patients with hip fracture in each group,~     totally 68 patients. Skin traction and position splint were applied after block~     randomization. Data regarding pain, comfort, satisfaction from care, immobilization comfort,~     complications, time of operation and hospitalization time were collected after intervention.~   "
58797|NCT02287558|"~     This study will evaluate patients > 18 years of age with transfusion-dependent~     gastrointestinal bleeding due to documented gastrointestinal vascular ectasia with or~     without concurrent hereditary hemorrhagic telangiectasia (HHT). This study will focus on~     documented bleeding sites in the small bowel, including the duodenum, jejunum and ileum.~     Eligible patients will have endoscopically-documented sites of vascular ectasia and will~     have required at least 4 units of blood transfusion or episodes of intravenous iron~     administration over the preceding four months.~   "
58798|NCT02287545|"~     Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after~     trabeculectomy.~   "
58812|NCT02287363|"~     The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP)~     patients and pure hyperthyroidism individuals. Meanwhile, the investigators also intended to~     evaluate the morphological difference in effected skeletal muscles and investigate their~     relation with genetic variance.~   "
58813|NCT02287350|"~     As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study~     are to characterize the pharmacokinetic (PK) profile and to determine the safety and~     tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild~     to moderate acute pain.~   "
58801|NCT02287506|"~     There are three main forms of diabetes: Type 1 diabetes, Type 2 diabetes and genetic~     diabetes. The treatment for each is very different because they have different causes.~     People with Type 1 diabetes stop making their own insulin, so need insulin injections~     instead, whereas people with Type 2 diabetes can keep making their own insulin but it may~     not work as well as it should, so they need to watch what they eat, and may also need~     tablets or eventually insulin injections. Genetic forms of diabetes have specific treatments~     according to the subgroup.~      It is not easy for doctors to be able to say for definite what kind of diabetes a person~     has, particularly in young adults, where the distinction between the types is less clear.~     Because of this, sometimes (in about 10% of cases) people are given the wrong diagnosis.~     This can have a huge impact as it means they could be on the wrong treatment from the start,~     so they cannot control their blood sugars properly, which can lead to increased problems~     with their health and poor quality of life.~      We think we have a way of improving this situation. We have developed a tool called an~     Optimised Diagnostic Strategy (ODS). This combines a person's clinical features (such as~     their age and weight), with blood tests looking for changes in their body's immune (defence)~     system, and a blood test looking for specific changes in their genetic code, to help~     accurately diagnose what kind of diabetes that person has. We now need to test this ODS to~     see if it is better at getting the right diagnosis and treatment from the start compared~     with what we do in routine clinical practice at the moment. This kind of project is called a~     Randomised Controlled Trial (RCT) and would involve patients from General Practitioner (GP)~     surgeries all over the United Kingdom (UK). The project would be expensive as it involves a~     lot of work by many people to get it set up and to keep it running. Before we can do this we~     need to do a pilot to see if the bigger study would be possible and practical to do. This~     pilot project will be done locally in Exeter and test all the parts needed for the larger~     scale RCT.~   "
58802|NCT02287493|"~     In a prospective, non-interventional, monocentric observational study the pharmacokinetic~     properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED)~     will be analyzed.~      Plasma specimens will be quantified using high Performance liquid chromatography (HPLC).~      Primary endpoint: Plasma levels of antiinfectives during SLED~      Secondary endpoints:~        -  28-day-mortality~        -  length of stay at the intensive care unit (ICU) and in hospital~        -  clinical and microbiological cure of infections~      Inclusion criteria:~        -  age: > 18 years~        -  patients under SLED~        -  antiinfective treatment~      exclusion criteria:~      - missing informed consent~   "
58803|NCT02287480|"~     The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola~     outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven~     therapy or prevention available at this time.~      The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in~     preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in~     large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials~     are needed. To accelerate this process, the World Health Organization (WHO) has constituted~     a consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use~     similar protocols to collectively include roughly 250 volunteers, the sample size required~     to identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization~     with 2 different doses of BPSC1001.~      The joint primary objectives of this single-center, double-blind, randomized~     placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of~     the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine~     dose and to define whether seroresponses differ significantly following immunization with~     the lower or higher vaccine dose.~   "
58804|NCT02287467|"~     Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is~     usually mild, but can cause serious illness or death. The purpose of this study is to test~     the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune~     immunoglobulin or IVIG) in people who are hospitalized for severe flu.~   "
58805|NCT02287454|"~     The study design was a parallel-group randomized trial with equal randomization. Recruitment~     and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive~     data was collected. Afterwards, the participants were randomly allocated to either the~     REHACOP group or the Control group. During 3 months the intervention with REHACOP program~     took place and at follow-up patients were again re-evaluated to evaluate the change in~     cognitive measure. Post-treatment assessment (finished by July 2013) was performed within~     the first week after completing the intervention.~      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to~     improve cognition of patients with Multiple Sclerosis (MS).~   "
58806|NCT02287441|"~     The objective of this study is to determine if differences exist in the total vegetable~     intake of groups that eat either tomato products versus raw vegetable product.~   "
58807|NCT02287428|"~     This research study is studying a new type of vaccine as a possible treatment for patients~     with MGMT-unmethylated glioblastoma. This research study is a Phase I clinical trial, which~     tests the safety of an investigational intervention and also tries to define the appropriate~     dose of the intervention to use for further studies. Investigational means that the~     intervention is being studied and that research doctors are trying to find more about it. It~     also means that the FDA (U.S. Food and Drug Administration) has not approved the~     Personalized NeoAntigen Cancer Vaccine for any use in patients, including people with~     glioblastoma.~      The purpose of this study is to determine if it is possible to make and administer safely a~     vaccine against glioblastoma by using information gained from specific characteristics of~     the participants tumor. It is known that glioblastomas have mutations (changes in genetic~     material) that are specific to an individual patient's tumor. These mutations can cause the~     tumor cells to produce proteins that appear very different from the body's own cells. It is~     possible that these proteins used in a vaccine may induce strong immune responses, which may~     help the body fight any tumor cells that could cause the glioblastoma to come back in the~     future.~   "
58808|NCT02287415|"~     Multiple-dose, open-label, single-period study consisting of three consecutive phases~   "
58809|NCT02287402|"~     The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose)~     0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to~     diet therapy and exercise therapy, and follow up the progress after the end of treatment in~     patients who was assessed as normoglycemic.~   "
58810|NCT02287389|"~     The purpose of this study is to evaluate the efficacy and safety of four interventional~     pulmonology techniques for the treatment of fibrotic central airway stricture.~      The four techniques are：~        -  balloon dilation~        -  balloon dilation plus cryotherapy~        -  balloon dilation plus spiculiform electrosurgery~        -  balloon dilation plus mitomycin C injection~   "
58814|NCT02287337|"~     The purpose of this study is to see if a recently developed clinical prediction rule (CPR)~     will successfully identify which patients with neck pain will respond rapidly and favorably~     to manipulation of their cervical spine.~   "
58816|NCT02287311|"~     The subject has a type of lymph gland disease called Hodgkin Disease (HD) or non-Hodgkin~     Lymphoma (NHL), T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus~     (CAEBV) which has come back, is at risk of coming back, or has not gone away after~     treatment, including the best treatment we know for these diseases. This research study uses~     special immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes~     (MABEL CTLs).~      Some patients with Lymphoma, T/NK-lymphoproliferative disease, or CAEBV show signs of a~     virus called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono~     or the kissing disease) before or at the time of their diagnosis. EBV is found in cancer~     cells of up to half the patients with HD and NHL, suggesting that it may play a role in~     causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV)~     infected by EBV are able to hide from the body's immune system and escape destruction. We~     want to see if special white blood cells (MABEL CTLs) that have been trained to kill EBV~     infected cells can survive in your blood and affect the tumor.~      In previous studies, EBV CTLs were generated from the blood of the patient, which was often~     difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months~     to make the cells, which is not practical when a patient needs treatment more urgently. To~     address these issues, the T cells in the current study were made in the laboratory in a~     simpler, faster, and safer way. The T cells we have made will still see LMP proteins but~     also two other EBV proteins called EBNA-1 and BARF. These cells are called MABEL CTLs. In~     order to ensure these cells are available for use in patients in urgent clinical need, we~     have generated MABEL CTLs from the blood of healthy donors and created a bank of these~     cells, which are frozen until ready for use. We have previously successfully used frozen T~     cells from healthy donors to treat EBV lymphoma and virus infections and we now have~     improved our production method to make it faster.~      In this study, we want to find out if we can use banked MABEL CTLs to treat HD or NHL,~     T/NK-lymphoproliferative disease and severe chronic active Epstein Barr Virus (CAEBV). We~     will search the bank to find a MABEL CTL line that is a partial match with the subject.~   "
58817|NCT02287298|"~     We propose to undertake a retrospective review of approximately 200 patients with a~     diagnosis of exudative macular degeneration treated with triple combination therapy~     (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at~     The Retina Center and compare those results with an additional group of approximately 200~     patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.~   "
58818|NCT02287285|"~     Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the~     role of endogenous glucagon-like peptide-1 (GLP-1).~   "
58819|NCT02287272|"~     The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993~     (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of~     the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of~     Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI~     administered alone or at steady-state of Cimetidine~   "
58820|NCT02287259|"~     Determine the efficacy and tolerability of olanzapine for treatment of acute depression in~     patients with bipolar II or bipolar disorder NOS compared with lithium.~   "
58821|NCT02287246|"~     To study post-operative efficacy of Exparel® for pain control in patients undergoing any~     Urogynecology surgery involving the posterior vaginal wall using a randomized,~     double-blinded placebo controlled trial.~   "
58822|NCT02287233|"~     This study consists of two phases: a Phase 1, or dose-escalation portion, that will evaluate~     the safety and pharmacokinetic profile of ABT-199 in combination with low-dose cytarabine~     (LDC), define the maximum tolerated dose (MTD), and generate data to support a recommended~     Phase 2 dose (RPTD) in treatment-naïve subjects with Acute Myelogenous Leukemia (AML); and a~     subsequent Phase 2 that will evaluate if the RPTD has sufficient efficacy and acceptable~     toxicity to warrant further development of the combination therapy.~   "
58823|NCT02287220|"~     The purpose of this study is to test the accuracy of a web cam-based biomedical device~     developed at UVA (not FDA-approved) that is designed to measure heart rate, respiratory~     rate, and oxygen saturation without requiring any patient contact. One potential application~     of such a device would be in the field of infant monitoring allowing parents (and~     physicians) to monitor the vital signs of infants continuously. The investigators therefore~     propose to record the heart rate, respiratory rate, and oxygen saturation of 100 infants~     (defined as children aged 12 months or less) who are receiving continuous oxygen, heart~     rate, and respiratory rate monitoring with a traditional vital signs monitor. The~     relationship between non-contact and gold standard (GE monitoring equipment) heart rate,~     respiratory rate, and oxygen saturation will be analyzed using regression and limits of~     agreement analysis.~   "
58824|NCT02287207|"~     The purpose of this pilot study is to determine the effect of transcranial direct current~     stimulation (tDCS) on brain activity and fine motor skills in patients with Parkinson's~     disease compared to healthy controls.~   "
58825|NCT02287194|"~     To document indications for cholangioscopy and clinical utility of the SpyGlass Direct~     Visualization System in China when used per standard of practice.~      Prospective, Post market, Multi-center, Non-randomized Study~   "
58826|NCT02287181|"~     A prospective, randomised, phase IV trial including 150 patients.~      To evaluate the effects of varied concentrations of remifentanil on the proposal~     requirements for the loss of consciousness and response to pain and to evaluate the~     haemodynamic changes and processed EEG (BIS) during induction of anaesthesia.~   "
58827|NCT02287168|"~     Surgical manipulation and handling of a tumor may cause dissemination of cancer cells~     through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may~     have preventive effect on positive peritoneal cytology occurred during gastrectomy in~     patients with gastric cancer.~   "
58828|NCT02287155|"~     As in many other countries in the world, the population in Switzerland is growing older.~     This also means an expansion of costs in the health system. Therefore, the investigators~     need to find concepts of health promotion to prevent people from getting ill and dependent~     of the health care system.~      Our project aims at developing a health promotion program for persons over 50 years of age~     in a rural area of Switzerland. The program's name is bliib gsund. This~     occupational-therapy directed health promotion program is conducted over a period of six~     months in two groups of eight persons each. The aim of the program is to enhance the quality~     of life of the participants, to mediate the competence of integrating health-promoting~     aspects in their daily life, and to maintain their independence in their life as long as~     possible. Persons over 50 often find themselves in a phase of transition in life, such as~     starting retirement, the loss of family members or children moving out. This program will~     provide them with the ability to continue their lifestyle in a more active way. It embraces~     topics such as more active pursuits of interests and carrying out personally meaningful~     activities.~      In preparation of the program, the investigators conducted a needs analysis to identify the~     needs relating to health-promoting offers of the inhabitants living in the specified region.~     The results showed a high interest and need for such programs. They also helped us to~     identify several relevant issues to be included in the presented health-promotion program:~     physical exercise in daily life, healthy nutrition, getting acquainted with new~     technologies, fall-prevention training and maintaining social contacts. The researchers and~     the designated occupational therapist, who will be the moderator of the program, can develop~     the program based on these results.~      The evaluation of the program should identify the effect of the program concerning the~     promotion of self-efficacy, the sense of coherence, quality of life and the program~     objectives. A questionnaire will be distributed before the program, immediately after and~     six months after the program.~   "
73026|NCT02101489|"~     This purpose of this study is to study is to see if intra-operative urethral length~     measurement with the Foley catheter will improve the placement of a synthetic sling in the~     mid-urethra.~   "
58830|NCT02287129|"~     Metabolic and Molecular Response evaluation for the individualization of therapy in~     adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for~     patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally~     advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal~     efforts will be done by investigation of molecular and metabolic biomarkers in relation to~     their predictive and prognostic value by correlating them with histopathologic responses and~     clinical outcome in an exploratory approach.~   "
58831|NCT02287116|"~     The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP~     (nasal continuous positive airway pressure)as the initial respiratory support when using~     minimal ly invasive surfactant therapy (MIST) in preterm infants.~   "
58832|NCT02287103|"~     Background: Skipping breakfast and/or overeating at evening, has been associated in type 2~     diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased~     overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also~     associated with increased plasma free fatty acids (FFA) along the morning until lunch. High~     plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin~     mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize~     that compared to eating breakfast the prolonged overnight fasting caused by the breakfast~     omission will result in increased postprandial glycemic response after subsequent isocaloric~     lunch and dinner in T2D individuals.~      Objectives: With this aim will study T2D patients in randomized crossover design to consume~     in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or~     omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same~     caloric content.~      Methods and Study Design: The YesB intervention will consist on three identical meals~     coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB~     intervention the breakfast will be omitted and the subject continue fasting until lunch.~     Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at~     19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with~     blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at~     the same time point the blood samples will be collected after 8:00 when the breakfast will~     be omitted.~      Expected results: The investigators expect that compared to NoB condition, in the YesB~     condition the postprandial response after lunch and dinner will be reduced for glucose and~     for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and~     dinner will be enhanced~   "
58833|NCT02287090|"~     Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based~     guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking.~     Our proposed study aims to fill these gaps by identifying the prognostic factors which will~     predict better outcomes of rotator cuff tears, based on both operative and non-operative~     treatment. The investigators will also compare outcomes of operative and non-operative~     treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.~   "
58834|NCT02287077|"~     The objective of this pilot study is to investigate the feasibility of performing umbilical~     cord milking in neonates who are depressed at birth.~   "
58835|NCT02287064|"~     The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect~     Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system~     function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6,~     10 and 11.~   "
58836|NCT02287051|"~     Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure~     depends on an adequate visualization of the mucosa of the colon.There is strong evidence~     that the quality of bowel preparation is inversely correlated with the interval between the~     end of the assumption of the purgative and the start of colonoscopy (shorter intervals are~     associated with higher levels of preparation).Recent studies have shown that split dose prep~     significantly improves the quality of bowel cleansing. In light of these data, both the~     American College of Gastroenterology (ACG) and the European Society of Gastrointestinal~     Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel~     cleansing. Despite these recommendations, the uptake of schemes in divided doses appears~     clearly underused in actual clinical practice. In particular, in Italy only a few centers~     routinely adopt the regime split as their first choice for the preparation for~     colonoscopy.The reasons why the split dose is under-utilized in clinical practice are not~     entirely clear, but probably in part reflecting gastroenterologists' concerns about~     potential elements that theoretically could make it less acceptable to the patient (get up~     early in the morning, potential problems during the journey from home to the hospital) The~     hypothesis of the study is that many patients would still be willing to accept these~     potential drawbacks if they were adequately informed about the positive impact of the scheme~     in divided doses on the effectiveness of bowel preparation, which results in higher~     reliability of the examination, shorter duration of the procedure, and less risk of~     rescheduling the exam in the near future~   "
58837|NCT02287038|"~     The current available treatments for PTSD are not fully effective for cognitive symptoms of~     PTSD and have high drop-out and poor engagement, two factors found to be most indicative of~     overall return to functioning for patients with PTSD. Successful completion of this pilot~     clinical trial may build a platform for future large scale double-blind, placebo-controlled~     studies using either atomoxetine or psycho-stimulants or other cognitive enhancing~     medications. The response inhibition related measurements are sensitive to psychotropic~     medications. Therefore it is advantageous for us to use GNG and Stop Signal approaches to~     investigate individual treatments response in the investigators' future research. The~     investigators believe GNG and Stop signal approaches together with pharmacogenetic approach~     will provide valuable information to direct future individualized medicine.~   "
58838|NCT02287025|"~     Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff)~     support and education on treatment discontinuation rates in the absence of progression in~     patients with metastatic colorectal cancer treated with regorafenib. Intensified education~     and support will be provided through an application for iPad which has automatic links to~     grading, dose reduction and side effect management ,as well as, references for additional~     articles.~   "
58839|NCT02287012|"~     This study aims to observe the effects of the availability of plerixafor on the time and~     effort associated with autologous peripheral blood stem cell collection.~   "
58840|NCT02286999|"~     The purpose of this study is to investigate the dose of a probiotic supplement~     (Bifidobacterium longum subsp. infantis) required to achieve predominant gut colonization in~     healthy newborn, breastfed infants. The study will also examine whether supplementation with~     this probiotic can reduce the chance of developing eczema and food allergies in enrolled~     infants.~   "
58917|NCT02285998|"~     The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully~     licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in~     protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age~     population.~   "
58841|NCT02286986|"~     Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P~     compared with placebo with respect to:~        -  Incidence, type and severity of adverse events (AEs)~        -  Effect on vital signs, including weight~        -  Effect on 12-lead electrocardiogram (ECG) findings~        -  Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic~          efficacy of GWP42003-P compared with placebo with respect to the incidence in~          convulsive seizures~        -  To determine the plasma concentration time curves for GWP42003-P and its major human~          metabolite, following escalating multiple doses of GWP42003-P.~        -  To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant~          anti-epileptic drugs (AEDs).~        -  To evaluate cognitive function, sleep quality and daytime sleepiness, in patients~          taking GWP42003-P in combination with AEDs.~   "
58842|NCT02286973|"~     This prospective randomized controlled trial was conducted To compare the efficacy of TNA in~     terms of total blood loss and the allogenic transfusion rate among the three study groups;~     intravenous alone, combined intravenous and low dose topical TNA and combined intravenous~     and high dose topical TNA.~      To evaluate the safety of each regimen in view of deep vein thrombosis and venous~     thromboembolism.~   "
58843|NCT02286960|"~     Despite the considerable use of oral steroids in the regular management of benign vocal fold~     lesions there is little evidence base in the literature. This study will investigate the~     efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner.~     The specific aim of this study is to determine the effectiveness of of a short course of~     oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic~     vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to~     either receive oral steroids or no steroids prior to the initiation of voice therapy. The~     therapist and individuals involved in the collection and analysis of data will be blinded as~     to whether the subject received drug. Prior to initiation of therapy subjects will be asked~     to return for an interval evaluation during which they undergo videostroboscopy and voice~     evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation~     to determine the best mode of therapy they will receive a behavioral voice therapy course,~     which includes a range of behavioral modifications and motor learning techniques, along with~     lifestyle measures. In all these phases acoustic and aerodynamic measurements will be~     collected as well as audio-visual material from the videostroboscopic exams. The~     investigators hypothesize that oral steroids will lead to a reduction in lesion size, which~     will substantially aid in the delivery and incorporation of voice therapy techniques,~     contributing to the improvement of overall laryngeal biomechanics and providing an ideal~     starting point for behavioral voice therapy.~   "
58844|NCT02286947|"~     The primary objective of this study is to explore safety and tolerability of eteplirsen in~     patients with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51~     skipping. The exploratory objectives are to evaluate the effect of eteplirsen on pulmonary~     function tests (PFTs) and other functional clinical measures.~   "
58845|NCT02286934|"~     A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on~     Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol~   "
58846|NCT02286921|"~     Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate~     (pre-chemotherapy for metastatic disease) will be treated on a randomized,~     multi-Institutional open label study to determine if treatment with intramuscular T given on~     a dose/schedule designed to result in rapid cycling from the polar extremes of~     supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve~     primary and secondary objectives vs. enzalutamide as standard therapy.~   "
58847|NCT02286908|"~     The aim of the study is to investigate if global strain and mechanical dispersion may~     predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with~     myocardial infarction and heart failure regardless of cause.~   "
58848|NCT02286895|"~     This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV)~     after a fourth dose is given at 9 months of age with local WHO Expanded Programme on~     Immunization (EPI) vaccines in Mali.~   "
58849|NCT02286882|"~     PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The~     primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     of single oral doses of PF-06409577 in healthy adult subjects.~   "
58850|NCT02286869|"~     This study measures the cardioventilatory coupling in critically ill patients during~     mechanical ventilation in controlled mode (pressure controlled) and in patient-driven mode~     (pressure support and neurally adjusted ventilatory assist).~   "
58851|NCT02286856|"~     The m.3243A>G mutation is the most frequent cause of mitochondrial disease in adults, for~     which currently no therapy is available and treatment is solely supportive. Since both~     malnutrition and obesity are frequently seen in these patients, an adequate nutritional~     intervention to improve body composition and function might improve the quality of life of~     these patients.~      Hypothesis / research questions Hypothesis part 1: Patients with mitochondrial disorders~     caused by the m.3243 A>G mutation have an increased risk for malnutrition.~      Hypothesis part 2 : Intervention study: Dietary intervention in adults with a mitochondrial~     disorder caused by the m.3243 A>G mutation has a positive effect on nutritional status,~     activity, hand grip strength, body composition, food intake, fatigue and quality of life.~   "
58852|NCT02286843|"~     Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2~     (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks~     HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer~     patients also benefit from medicines that attack HER2, but we do not know why or which~     patients will benefit. This study uses a new imaging method, 89Zr-trastuzumab PET/CT, to~     identify patients that may benefit from medicines that attack HER2. This is experimental.~   "
58853|NCT02286830|"~     Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until~     progression in bone disease compared to patients who stop treatment after two years?~      Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease~     in the individual patient?~      Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in~     Multiple Myeloma compared to conventional radiography~   "
78108|NCT02035007|"~     The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac~     Output)-derived transpulmonary thermodilution technology in patients with heart diseases.~   "
58854|NCT02286817|"~     This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting~     genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study~     are to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral~     administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for~     the effect of NFC-1 on ADHD severity and global functioning during and following four weeks~     of continuous treatment. Exploratory analyses will be performed to assess effect size of~     specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This~     study will be conducted at a single clinical site, the Jefferson University Hospital PKU~     (Philadelphia, PA).~   "
58855|NCT02286804|"~     Up to 30 enrolled subjects will be treated. Enrolled subjects will receive Ultherapy®~     treatments along each length of the spider vein. Follow-up visits will occur at 30 and 60~     days post-treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit.~   "
58856|NCT02286791|"~     The objective of this study is to determine whether regular Mindful Awareness Program (MAP)~     may reverse cognitive impairment and/or prevent further cognitive decline among older~     adults. 60 elderly with mild cognitive impairment (MCI) were randomized to participate in~     either the MAP or the Health Education Program (HEP). Sessions will be conducted weekly for~     12 weeks, and monthly for 6 months. Participants would be assessed at 3 time-points: at the~     start, at 3-months and at 9-months.~      It was hypothesized that as compared to HEP participants, MAP participants will (1) have~     improved functional connectivity, (2) have a decreased risk in cognitive decline and (3)~     report higher psychological well-being.~   "
58857|NCT02286778|"~     The purpose of this study is to confirm the findings of an early study and expand our~     knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP~     (Adenosine-5'-Triphosphate) Inhibitor.~   "
58858|NCT02286765|"~     Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on~     the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days~     following the last treatment.~      Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.~   "
58859|NCT02286752|"~     Postoperative nausea and vomiting is one of most common complications after general~     anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non~     smoker status, opioid administration are known as risk factors for developing postoperative~     nausea and vomiting.~      It has been suggest that antagonism of residual neuromuscular block with a mixture of~     neostigmine and atropine at the end of the surgery increases the risk of postoperative~     nausea and vomiting.~      Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse~     effects include slight coughing, movement, an altered taste sensation in the mouth,~     transient prolongation of the QT interval, hypersensitivity, and a short term prolongation~     of the activated partial thromboplastin time.~      The aim of this study was to compare the sugammadex versus neostigmine plus atropine for~     reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative~     nausea and vomiting.~   "
58860|NCT02286739|"~     The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist~     the surgeon with tibiofemoral rotational alignment by testing the precision and variability~     of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients~     with a combined axial rotation couple at the tibiofemoral joint and quantitative~     intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative~     knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to~     measure post-operative alignment and to evaluate the prevalence and location of radiolucency~     and/or osteolysis.~   "
58861|NCT02286726|"~     The goal of this clinical research study is to compare different dose levels of CPX-351. The~     safety and efficacy of the drug will be studied in all dose levels.~   "
58862|NCT02286713|"~     Educational research study where goal is to test educational materials that help people make~     informed decisions about lung cancer screening.~   "
58863|NCT02286700|"~     The purpose of this study is to compare the effects of an amino acid moisturizing cream and~     desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to~     moderate atopic dermatitis/eczema.~   "
58864|NCT02286687|"~     The goal of this clinical research study is to learn if talazoparib can help to control~     advanced cancer in patients who have a specific type of alteration. The safety of this drug~     will also be studied.~   "
58865|NCT02286674|"~     Anxiety in children undergoing surgery is a central concern to both parents and healthcare~     workers, including nurses, surgeons, and anesthesiologists. It has been ranked by~     anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1).~     This study would determine whether such devices would decrease anxiety in children prior to~     induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be~     enrolled.~   "
58866|NCT02286661|"~     Distal radius fracture (DRF) is among the most common fractures of the long bones, which~     comprise one sixth of all fractures. Due to its high prevalence, effect on patients'~     everyday life, and cost on national health resources, its proper management is very~     important. The investigators performed this prospective randomized clinical trial on 100~     patients with DRFs. 50 patients were treated in each group either by short or long arm cast.~     Patients were visited during the 6th and 18th weeks after the reduction regarding loss of~     reduction and possible complications.~   "
58867|NCT02286648|"~     The purpose of this study is to evaluate the clinical and radiographic success rate of~     Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.~   "
58868|NCT02286635|"~     The primary objective of the study is to determine the potential effects of multiple doses~     of rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort~     active metabolite (21 desacetyl-DFZ) in healthy adult subjects.~   "
58869|NCT02286622|"~     This is a non-randomized, open-label, single-dose study to compare the PK of 21~     desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy~     matched control subjects (age, body mass index [BMI], and gender).~   "
58870|NCT02286609|"~     This is a non-randomized, open-label, single-dose study to compare the PK of~     21-desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with moderate hepatic~     impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched~     control subjects (age, body mass index [BMI], and gender).~   "
58871|NCT02286596|"~     Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold~     raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery~     disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been~     proved to be a reliable method to decrease LDL-C concentrations and therefore decrease~     cardiovascular disease risk in HoFH. The objective of this crossover study was to compare~     efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran~     sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and~     LDL particles size in a cohort of HoFH subjects.~   "
58872|NCT02286583|"~     Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot~     objects in the body. When it comes to the breast, causes of deep structure hot spots are~     numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective~     of this study is to test the sensitivity of the Medical Radiometer in detecting the hot~     spots in the breast.~   "
58873|NCT02286570|"~     Trauma victims had to be intubated at the scene of area in different conditions.~     Face-to-face intubation in an entrapped patient is one of these situations. The~     investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating~     face-ro-face intubation in adult patients aged between 18-60 years.~   "
58874|NCT02286557|"~     Up to 95% of individuals with Multiple Sclerosis report experiencing cognitive fatigue,~     characterized by a lack of energy, feelings of exhaustion, an the perception that one is~     unable to partake in daily activities. The goal of this project is to test whether~     methylphenidate (MP), a well-known psychostimulant, can effective treat fatigue experienced~     by individuals with MS.~      The current study will test the effect of MP on MS fatigue through a clinical trial. Every~     participant in the study will be exposed to both the drug and the placebo for a period of~     time. Both the investigators and participants will be unaware whether participants are~     receiving the drug or the placebo.~      Upon successful completion of the study, physicians will be able to evaluate the potential~     prescription of MP to treat fatigue in persons with MS based on solid research evidence.~     Importantly, MP is already an FDA approved widely used medication in multiple clinical~     populations.~   "
58875|NCT02286544|"~     Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is~     routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial~     infarction and variably recommended in ACS-guidelines, despite very limited data supporting~     a beneficial effect.~      Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary~     percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury~     in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood~     flow achieved with primary PCI can give rise to further damage, so-called reperfusion~     injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide~     range of pathological processes. Vascular leakage, activation of cell death programs,~     transcriptional reprogramming, no reflow phenomenon and innate and adaptive immune~     activation all contribute to tissue damage, thereby determining the infarct size. The effect~     of oxygen treatment on these pathological processes, on the extent of IR-injury and the~     final infarct size in STE-ACS patients has not previously been studied.~      ACS is characterized by a systemic inflammation with typical elevations of soluble~     inflammatory markers as well as changes in white blood cells. The inflammatory reaction~     might be considered helpful in restoring myocardial tissue structure and function, but on~     the other hand it might worsen IR-injury by activating various pathological processes. In~     human experimental studies, Salmonella typhi vaccine has been used to create a standardized~     model of systemic inflammation and when administered to healthy volunteers the vaccination~     has not been associated with any adverse events.~      In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of~     role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on~     morbidity and mortality in ACS patients is being investigated. In a substudy of the~     DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on~     IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the~     pathological processes involved.~      The presented study is an experimental pilot study performed in healthy volunteers with a~     Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen~     treatment on biological systems involved in the pathogenesis of IR- injury.~   "
58876|NCT02286531|"~     Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II~     (referring to the current diagnostic gold standard represented by the histopathology exam of~     a tumor sample).~   "
58877|NCT02286518|"~     The purpose of this study is to evaluate the safety and tolerability of TAK-114 following~     single and multiple ascending oral doses in healthy Japanese male participants.~   "
58878|NCT02286505|"~     Early dementia diagnosis improves patient and carer experience, links them to appropriate~     care and support and enables timely symptomatic treatment. The guidelines of the UK National~     Institute for Health and Care Excellence recommend brain Magnetic resonance imaging (MRI) to~     assist with the diagnosis in suspected dementia. Recently, computerised analysis of MRI~     scans, also known as automated brain morphometry, has shown potential to detect the brain~     changes characteristic of early dementia, and may therefore be a useful addition to the~     standard reporting performed by a neuroradiologist. The present pilot study will assess~     whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis~     in clinical practice as an addition to the existing diagnostic pathway in a memory clinic~     setting. The main purpose of the study is to compare measures of the clinicians diagnostic~     confidence in patients with and without brain morphometry.~   "
58879|NCT02286492|"~     The objective of the program is to provide access to TAS-102 to patients with metastatic~     colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy~     with TAS-102 and in whom therapy with TAS-102 is clinically indicated.~   "
58880|NCT02286479|"~     Skin abscesses are among the most common soft tissue infections cause emergency room visits~     frequently. Management of abscess drainage and prevent further complications are important~     entities for emergency physicians. Historically primary incision and drainage (I&D)~     technique has found very effective method of abscess drainage, however a novel technique~     loop drainage holds promising. The purpose of our study is comparison efficacy of I&D and~     loop drainage techniques in patients with cutaneous abscess.~   "
58881|NCT02286466|"~     The proposed study seeks to implement a randomized controlled trial to evaluate the~     effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT)~     intervention for use as a self-administered mobile application (mobile app) to treat anxiety~     in patients with metastatic cancer.~   "
58882|NCT02286453|"~     Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee~     Compared with Diclofenac. This study was designed as double blind, randomized controlled~     trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat~     University (No: 1 Faculty of Medicine)~   "
59189|NCT02282475|"~     Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be~     associated with adverse maternal and fetal pregnancy outcomes. This study will examine how~     fat storage changes during pregnancy; and if how the body stores fat impacts one's ability~     to metabolize glucose (sugar) during pregnancy.~   "
58883|NCT02286440|"~     The overall goal of this investigator-initiated trial is to evaluate the impact of platform~     algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic~     (PD) genomic variation on treatment outcome of depression in adolescents. This new~     technology may have the potential to optimize treatment selection by improving response,~     minimizing unfavorable adverse events / side effects and increasing treatment adherence~   "
58884|NCT02286427|"~     Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain,~     superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous~     cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions~     but clinical experience suggests that most epidermise in less than a month. Some, however,~     for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily~     defined for this study as lasting more than three months are a source of major discomfort~     and could play a decisive role in the morbidity and mortality of the disease.~      The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of~     chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3)~     from the start of treatment.~   "
58885|NCT02286414|"~     The aim of the study is to compare, in real life, the risk benefit (including both major~     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral~     anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering~     from non valvular atrial fibrillation and living in community or nursing home settings.~      An observational multicenter prospective inception cohort will be conducted within the~     PRESAGE-Network, an ongoing active network on drug safety in older adults in the Ile de~     France (IDF) area (Paris and its surroundings) involving a sample of general practitioners~     (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and~     pharmacists will prospectively include all octo+ patients they care for, newly treated with~     an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years.~   "
58886|NCT02286401|"~     The purpose of this pilot study proposal is to test the ability of Transluminal Flow~     Encoding (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication~     for invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for~     suspected coronary disease.~   "
58887|NCT02286388|"~     This clinical trial is a national multicenter randomized controlled trial performed in~     parallel groups aiming to validate a treatment that preserves pulp vitality of mature~     permanent posterior teeth through partial removal of carious tissue and restoring tooth~     structure using a simple filling in one session, thus delaying premature tooth aging.~      Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type~     of excavation carried out (partial vs. complete caries removal) and secondly for the nature~     of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second~     randomization will not be carried out for teeth requiring endodontic treatment after the~     first randomization.~      The study's primary objective will be to compare, at 1 year of follow-up, the efficacy~     (binary success criteria) of partial caries removal versus complete caries removal in~     occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars~     except third molars). Secondary objectives will include the comparison, at 1 year of~     follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch~     adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another~     secondary objective will be to compare, at two and three years of follow-up, the efficacy of~     partial versus complete caries removal.~      The primary outcome is the success of the caries removal protocol at one year, measured~     according to 5 FDI criteria, while the secondary outcome is the contribution of the~     functional and biological dimensions of the 5 FDI criteria items to determining success or~     failure of the treatment. The outcome of success will be the same for all objectives,~     primary and secondary.~   "
58888|NCT02286375|"~     This paper aims to describe the research protocol that will be used to determine the~     effectiveness of a health-social partnership intervention programme among community-dwelling~     older adults~   "
58889|NCT02286362|"~     This non-interventional prospective study will assess the safety of Herceptin SC~     (subcutaneous administration) as used in routine clinical practice. Patients with~     HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be~     treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with~     Herceptin SC in routine clinical practice use are eligible to participate. The total study~     duration is anticipated to be 38 months.~   "
58890|NCT02286349|"~     This study aims to evaluate the effect of noninvasive brain stimulation in adults with ADHD~     symptomatology compared them with healthy adults. For this, volunteers will allocate into~     two groups (experimental and control), will pass through session two types of transcranial~     stimulation: Repetitive Transcranial MagneticsStimulation (rTMS) and transcranial direct~     current stimulation (tDCS); considering two session types (real and sham). Attentional~     assessment will be carried out through specific neurocognitive tests applied before and~     after each session of stimulation~   "
58891|NCT02286336|"~     The aim of this study is to determine the minimum effective concentration of local~     anesthetic (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for~     surgical anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle~     aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal~     to the shoulder.~   "
58892|NCT02286323|"~     We hypothesized that the BONFILS is beneficial for intubation of manikins while performing~     CPR. In the current study we compared the performance of the BONFILS and the Macintosh~     laryngoscopes with respect to their effectiveness and time to successful ETI during chest~     compression (CC) using an adult manikin.~   "
58893|NCT02286310|"~     The aim of this study is to investigate the effect of exercise program on 3-dimensional~     scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.~   "
58894|NCT02286297|"~     Endotracheal intubation (ETI) is perceived as the optimal method of providing and~     maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC)~     guidelines emphasized the importance of minimal interruption during cardiopulmonary~     resuscitation (CPR). These guidelines also suggest that skilled operators should be able to~     secure the airway without interrupting chest compression. The aim of the study was to~     compare time and success rates of different available video laryngoscopes and the Miller~     laryngoscope for emergency intubation during simulated pediatric CPR.~   "
58895|NCT02286284|"~     Introduction Preeclampsia is a multifactorial disease that is responsible of important~     adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble~     fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental~     models and circulates at elevated levels in human preeclampsia.~      The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in~     women with very early severe preeclampsia at less than 26 weeks' gestation Patients and~     methods Phase II trial. Women with singleton pregnancy having severe preeclampsia at~     23-256/7 weeks' gestation. Women under 18 years, with multiples, or severe fetal growth~     restriction (less than 5th centile), or abnormal fetal heart rate, or maternal complications~     (abruption, eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded~     from the study. After blood pressure and maternal stabilization, women are approached for~     information and if they agree, to sign the trial consent.~      Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation.~      Primary endpoint or success of the procedure: baby alive or alive at 6 months if~     hospitalized Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%,~     beta power; 90%. First step: number 8 patients. If success equal or less than 5, the study~     is stopped.~      Second step: if success of 6 or more, the study is continued for 9 more patients.~      Overall, a maximum of 17 patients will be included. The final success of extracorporeal~     removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months~     if hospitalized.~   "
58896|NCT02286271|"~     Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et~     al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been~     avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal~     seizures to allow body re-positioning, to maintain an open airway and to administer rescue~     medication. There are several seizure alarms commercially available but are often unreliable~     with many false alarms. The aim of this study is to investigate a novel seizure detection~     system with a unique algorithm.~   "
58897|NCT02286258|"~     The purpose of this study is to validate in comparison to a reference method (inuline) two~     novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in~     chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.~   "
58898|NCT02286245|"~     Telephone medical advice in general practice is expanding. The Cochrane Database concludes~     in 2008 that there is not enough data about its use regarding out-of-hours general~     practitioners workload, emergency department visits, cost, safety and patient satisfaction.~     The aim of this study is to assess the effectiveness of telephone medical advice given by a~     general practitioner in a call centre for patient presenting isolated fever or~     gastroenteritis symptoms.~   "
58899|NCT02286232|"~     Chronic low back pain is a common condition that can negatively impact quality of life and~     that lacks highly effective treatment options. The YMCA developed different iterations of a~     stretching exercise program as a community based treatment for low back pain from 1974-2004.~     Though anecdotally successful, the YMCA stretching exercise program(s) was not~     scientifically evaluated for efficacy and became obsolete. The purpose of the study is to~     test the efficacy of a previously popular YMCA stretching exercise program(s) for back pain.~     The stretching exercise program that will be studied is a collection of all the resources~     available for the YMCA stretching exercise program(s). The most recent criteria from a~     National Institutes of Health sponsored Task Force to study chronic low back pain were~     applied to this study.~   "
58900|NCT02286219|"~     To evaluate the safety, tolerability, dose limiting toxicity (DLT), and maximum tolerated~     dose (MTD), of FS102(BMS-986186) when administered intravenously (IV) to subjects with~     relapsed or refractory solid tumors that overexpress HER2 and who have no standard treatment~     options.~   "
58901|NCT02286206|"~     The objectives of this 15-day study are:~        1. To compare steady-state trough plasma concentrations of clozapine and its metabolite~          norclozapine when given once daily and twice daily (at the same total daily dose)~        2. To determine if frequency of clozapine administration has an effect on:~             1. Symptoms of schizophrenia~             2. Adverse effects of clozapine~             3. Fasting blood glucose, lipids, creatinine, and urea~             4. Weight and waist circumference~   "
58902|NCT02286193|"~     This project will engage patients and health care teams to develop, implement, and~     rigorously evaluate a new lay health worker role (Community Resource Specialist, CRS) for~     primary care teams. The CRS will link patients and healthcare clinics with community~     resources.~   "
58903|NCT02286180|"~     Background and objectives:~      Recently the news of intern doctors' death due to overloaded work or committing suicide has~     made the authorities concerned put emphasis on the mental health care of medical staffs and~     related policies of psychological interventions. The prefrontal lobe plays an important role~     in the working memory, executive function and problem-solving abilities of the brain.~     Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal~     love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the~     cortical functions of the frontotemporal regions and has been widely used as a biomarker to~     aid in differential diagnoses in major psychiatric illnesses in Japan. The present study~     will investigate impact of the job stress on brain cortical activity during a verbal fluency~     test (VFT) by using fNIRS.~      Materials and methods:~      A total of 100 participants will be recruited. Clinical measurements of mood status by~     Beck's Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese~     Version of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout~     Inventory will be arranged. The relationship between clinical measurements and cortical~     activity during a VFT will be analyzed by Pearson's correlation. Multiple regression~     analysis will be applied to investigate the independent contributions of mood status and job~     stress.~      Expected results and contributions of the study:~      Job stress, depression, and anxiety are significantly negatively correlated with cortical~     activity of prefrontal regions. The importance of mental health of medical staffs under high~     job stress should be stressed.~   "
58904|NCT02286167|"~     The primary goal of this study is to assess the feasibility and biologic activity of a~     modified Atkins-based diet combined with short-term intermittent fasting, a GLioma~     Atkins-based Diet (GLAD), in patients with central nervous system GBM.~   "
59190|NCT02282462|"~     A 2 x 2 randomized study testing active versus passive drainage and regulated versus~     unregulated pleural pressure in patients undergoing anatomic lung resection~   "
58905|NCT02286154|"~     The primary objectives of this prospective study of hydroxyurea for children with sickle~     cell anemia are 1) Develop and prospectively evaluate a population~     pharmacokinetic/pharmacodynamics model to predict the maximum tolerated dose (MTD); 2)~     Identify urine biomarkers of hydroxyurea adherence using a novel metabolomics approach; 3)~     Identify pharmacogenomics modifiers of hydroxyurea MTD; and 4) Longitudinal monitoring of~     the effect of hydroxyurea upon organ function and quality of life.~   "
58906|NCT02286141|"~     Back pain is one of the most common, controversial and costly problems in healthcare.~     Despite numerous studies, care for back pain has deteriorated over time and become much more~     expensive. The risk stratification approach developed in England and found effective in~     National Health Service general practices in the UK provides a very promising strategy for~     improving care for back pain in the U.S.~      The MATCH trial will use a cluster randomization design involving 6 primary care clinics at~     Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard~     training in the use of Group Health back pain guidelines and 3 clinics will receive this~     standard training plus supplemental training. Primary care clinicians and physical~     therapists in the intervention group will receive training in the use of the STarTBack risk~     stratification strategy for matching the most appropriate evidence-based treatments to the~     needs of patients in each risk level. We will evaluate the effect of this supplemental~     training on patient outcomes, clinician and physical therapist knowledge and comfort~     treating patients with back pain, and utilization of services for back pain.~   "
58907|NCT02286128|"~     This study determines whether NF-кB dependent proinflammatory state found in type 2 diabetes~     yield to a higher RAGE activation in the mesenchymal stem cell, as well as the effects of~     the proinflammation on osteoblast differentiation impairment and cellular apoptosis in type~     2 diabetic patients. This study will compare non-diabetic control subjects and type 2~     diabetic patients with metformin monotherapy failure in the aspect of 1) serum markers for~     NF-кB dependent proinflammatory state and its intracellular signals, 2) osteogenic~     differentiation and apoptosis of the mesenchymal stem cells, and 3) serum AGE, RAGE and~     cellular RAGE activation.~   "
58908|NCT02286115|"~     The goal of this study is to test the efficacy, feasibility, and acceptability of providing~     an experiential assessment interview that targets health, and emotional and stressful~     experiences in a tertiary care setting specializing in women's urology.~   "
58909|NCT02286102|"~     The examination of the ability of the OrthoPAT® blood collection device to decrease the~     transfusion rate and volume of adults undergoing posterior spine surgery for deformity~     correction of 6 levels or more.~   "
58910|NCT02286089|"~     The main objective of the study is evaluation of the safety and tolerability of OpRegen -~     human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also~     include initial exploration of the ability of transplanted OpRegen cells to engraft,~     survive, and moderate disease progression.~   "
58911|NCT02286076|"~     To compare changes in follicular ovarian reserve in women before and six months after~     laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian~     reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile~     women of the same age group.~   "
58912|NCT02286063|"~     The main aim of this project is to establish whether ambulatory oxygen in patients with~     fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant~     improvement in health status. The core of the project will be a four week randomised,~     crossover controlled trial of ambulatory oxygen used during daily activities. The optimal~     Oxygen flow rate is determined by titration at screening visit and administered during~     activity for a two-week period, compared to two weeks off oxygen.~   "
58913|NCT02286050|"~     The purpose of this study is to evaluate the effect of a nursing program in patients with~     cystic fibrosis.~   "
58914|NCT02286037|"~     Assessments of mechanical skin sensitivity include psychophysical responses to stimulation~     with calibrated polyamide monofilaments.~      One of the applications of polyamide monofilaments are the assessments of magnitude of~     secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased~     mechanical sensitivity.~      The objective of the study is to investigate the hypothesis, based on previous studies, that~     a light tactile stimulus delineates a larger SHA than stimulation with a more rigid~     monofilament.~      Twenty-three healthy participants were included in this randomized, two-observer,~     test-retest study.~      A highly significant positive correlation between the bending force of the polyamide~     filaments and the magnitude of SHA was demonstrated. The weighted-pin instrument showed~     significantly and consistently larger areas than the polyamide monofilaments.~      The hypothesis was rejected: a light tactile stimulus did not delineate a larger secondary~     hyperalgesia area than stimulation with a more rigid monofilament. The weighted-pin~     instrument seems an alternative to the conventional polyamide monofilaments.~   "
58915|NCT02286024|"~     Depression is a debilitating illness with a risk of developing a treatment resistant form.~     Currently, diagnosis is purely clinical with little features available to identify~     potentially adverse developments. Clinical features such as early onset age, prolonged~     episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of~     resistance to conventional treatments. According to neuroimaging knowledge about the~     pathophysiological mechanisms, involving front-limbic functional networks supporting the~     functions of emotional regulation and reward system, recent work has focused on the~     identification of neuroimaging biomarkers predicting therapeutic response. Among the regions~     of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions~     participating in the Default Mode Network Training (Medial prefrontal cortex, posterior~     cingulate cortex, inferior parietal lobe) are most frequently areas associated with the~     prediction of therapeutic response. Limitations most reported in these studies are the~     heterogeneity of experimental paradigms (resting state, cognitive or emotional functional~     tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms~     studied, different techniques (as that we consider remission (threshold score) or response~     (50% decrease from baseline score), and the sample size. Knowing that MRI into daily~     clinical practice in the SHU of Adult Psychiatry, as the balance sheet of the disease,~     monitoring its evolution, as in assumption rTMS (repetitive Transcranial Magnetic~     Stimulation) (pretreatment assessment and neuro), the identification of neuroimaging~     biomarkers in a population of patients with clinical criteria of Mood Depressive Episode,~     with an acquisition of identical and reproducible image daily routine methodology appears to~     be a reliable way to correct the heterogeneity of conventionally published studies on the~     topic. This study aim to identify, in routine care, predictive clinical and neuroimaging~     markers of poor outcome in major depressive disorder.~   "
58916|NCT02286011|"~     The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous~     Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective,~     single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical~     trial.~   "
58918|NCT02285985|"~     In this research study, Investigators will be comparing the effects of a medication~     Saxagliptin versus placebo (a similar looking pill that contains no medication) on~     inflammation in the body.~      Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue~     inflammation in obese individuals and this is characterized by decreases in a) reactive~     oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway~     activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e)~     secretion of pro-inflammatory factors.~   "
58919|NCT02285972|"~     Propofol remains the most common drug for induction of general anaesthesia, although it~     causes considerable pain or discomfort on injection. Anesthesia providers have attempted a~     large number of remedies to prevent this pain on injection. Previously explored ideas~     include injecting propofol into larger veins, warming of the hand with hot packs, and~     intravenous pretreatment with numerous other medications. No studies to date have looked at~     the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by~     propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for~     pretreatment of propofol related pain on injection.~   "
58920|NCT02285959|"~     The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of~     all primary brain tumors in adults. This group of tumors also exhibits the most aggressive~     behavior, resulting in median overall survival durations of only 9-12 months for GBM.~     Initial therapy consists of surgical resection, external beam radiation or both. Currently,~     all patients experience a recurrence after this first-line therapy, so improvements in both~     first-line and salvage therapy are critical to enhancing quality-of-life and prolonging~     survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can~     effectively increase the concentration of drug delivered to the brain while sparing the body~     of systemic side effects. This technique threads a tiny catheter through the patient's~     femoral artery in the leg, up through the body and neck and into the brain. Once the~     catheter reaches the brain, chemotherapy is released to the blood vessels that feed the~     tumor.~   "
58921|NCT02285946|"~     During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a~     positive end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30~     seconds. The realization of MRA is one of three main elements of mechanical ventilation~     called protective. This ventilatory strategy, originally described for the ventilation of~     acute respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is~     based on a decrease tidal volumes, optimization of PEEP and the realization of MRA.~     Protective ventilation limit the occurrence of atelectasis, the surdistentions and,~     ultimately, significantly decreases postoperative complications.~      The MRA is currently recommended in the major surgery. Most spine surgery (eg~     transpedicular fixation) used in this definition, the MRA are indicated and now commonly~     used. This type of surgery requires further positioning the patient in the prone position~     (DV). The DV modifies the compliance of the chest respiratory characteristics and changes~     (increase in insufflation pressure) and hemodynamic (decreased venous return) of the~     patient.~      Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known.~     The aim of this observational study, non-interventional, is to compare the hemodynamic and~     respiratory effects of MRA performed in DV to those of MRA performed in the prone position~     (DD).~      The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA~     performed in DV is different from those conducted in DD. A better understanding of~     hemodynamic and respiratory characteristics of MRA performed in DV would provide a more~     tailored to this type of surgery respiratory optimization strategy and reduce respiratory~     complications of this surgery.~   "
58922|NCT02285933|"~     The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting~     balance exercises using virtual reality training will provide additional gains in balance~     ability and function over standard inpatient rehabilitation in stroke patients.~   "
58923|NCT02285920|"~     The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center~     study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal~     disease.~   "
58924|NCT02285907|"~     To determine whether the consumption of a beef-rich lunch improves appetite control,~     satiety, and energy intake regulation while reducing food reward and food cravings compared~     to the consumption of a soy-rich lunch when matched for macronutrients and fiber content or~     when match for serving size. The mechanisms of action surrounding the differential responses~     of beef versus soy proteins were also explored.~   "
58925|NCT02285894|"~     This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can~     open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated~     patients.~   "
58926|NCT02285881|"~     Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different~     healthcare settings achieve all treatment goals to prevent cardiometabolic disease. A more~     personalised approach with shared decision making should increase that percentage. Because~     the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with~     slightly different intensities, it may be a good starting point to discuss with the patients~     their diabetes treatment, taking into account both the intensity of treatment, clinical~     factors and patients' preferences. The aim of the study was to evaluate whether such an~     approach increases the proportion of treatment goals that T2DM patients achieve.~      Methods: In a cluster-randomised trial in 40 primary care practices that participated until~     2009 in the ADDITION Study, 150 T2DM patients 60 - 80 years, known with T2DM for 8-15 years,~     will be included. Practices are randomised a second time, i.e. intervention practices in the~     ADDITION study could be control practices in the current study and vice versa. For the GPs~     from the intervention group a 2-hour training in shared decision making (SDM) was developed~     as well as a decision support tool to use during the consultation. These GPs plan the first~     visit with the patients to decide on the intensity of the treatment, personalised targets~     and the priorities of treatment. The control group will continue with the treatment they~     were allocated to in the ADDITION study (treatment-as-before). Follow-up: 24 months. The~     primary outcome is the proportion of patients who achieve all three treatment goals (HbA1c,~     blood pressure, total cholesterol) at 24 months. Secondary outcomes are the proportion of~     patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol , body~     weight, not smoking), evaluation of the SDM process (SDM-Q9), satisfaction with the~     treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36,~     EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared~     between groups by estimating the relative risk of meeting the treatment targets. For the~     secondary outcomes mixed models will be used.~      Discussion: To achieve optimal diabetes care with a higher proportion of achieved~     individualised treatment goals, the SDM approach including a multi-faceted decision support~     tool might be useful. An intervention with such a support decision tool is designed.~   "
58988|NCT02285075|"~     The current study aimed to explore the pharmacokinetics of temocillin in patients treated~     with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time~     above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained~     with a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these~     doses given after haemodialysis sessions only.~   "
58927|NCT02285868|"~     The investigators goal is to provide a mechanism that allows for a better understanding of~     patient outcomes following rehabilitation. This includes functional outcomes measured by~     standardized and validated tools from the published literature. It incorporates~     comorbidities and patient demographic characteristics. It includes measures of general~     health as well along with activities of daily living and behavioral health aspects. Measures~     of quality and satisfaction and use of Net Promoter Scores also are included. All of these~     components come together to form a remarkably comprehensive picture of patients and their~     associated outcomes. This is a unique milestone in rehabilitative care and will act to~     inform and direct evidence-based approaches and treatment guidelines.~      Data are collected via the investigators proprietary electronic medical record system and~     are synthetic to the clinical process—that is, the data are collected in real-time with~     patients and the scores are immediately provided to the treating therapist as well as~     archived for later Registry and scientific use. Subsequent reporting can be risk adjusted to~     any variable collected which yields robust insights as to idiopathic patient conditions.~     However, no PHI information will be available.~   "
58928|NCT02285855|"~     The goal of this clinical research study is to learn if giving metformin in combination with~     radiation therapy is more effective than radiation therapy alone. In this study,~     participants will receive either metformin or a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to~     be compared with a study drug to learn if the study drug has any real effect.~   "
58929|NCT02285842|"~     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and~     efficacy of its THA and resurfacing components marketed in the EU. These types of studies~     are required by regulatory authorities for all THA and resurfacing devices that do not have~     medium to long-term clinical evidence available at the time of gaining approval to market in~     the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
58930|NCT02285829|"~     During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in~     routine use for prevention of possible nerve injuries during placement of screw into~     pedicle. Pedicle screw stimulation test is performed to assess if screw placement is~     encroaching on the nerve roots. Relative distance between the pedicle screw and the~     neighbouring root can be estimated by the intensity of the current required to activate the~     root and appropriate muscle. A properly placed screw can be distinguished from those~     perforating the pedicle wall by its higher minimum level of electrical current needed to~     elicit a muscle response. The minimum level is deemed as threshold. This test is based on~     compound muscle action potential (CMAP) and use of neuromuscular blocking agents (NMBA)~     should be avoided because of possible cause of false negative results of screw stimulation~     test. Neuromuscular blocking agents, which are in routine use during anesthesia, will have~     effect on muscle action potential. When NMBA are used current stimulus will depolarize the~     same number of axons and the associated muscle response will be present but of lower~     amplitude because some percentage of motor fibers will be blocked by activity of NMBA. At~     this point, stronger stimulus is needed to recruit additional axons/muscle fibers , and~     hence, the measured threshold is elevated.~      Train of four (TOF) test is method used to determine level of neuromuscular blockade, by~     stimulation of peripheral nerve and following induced muscle contractions. Interpretation of~     muscle contractions may be by subjective (visual) or objective (quantitative) method.~     Quantitative TOF test may be used prior screw stimulation test by calculating T4/T1 ratio~     and obtaining quantitative value which shows level of neuromuscular blockade. Residual~     neuromuscular blockade may be present before screw stimulation test, and effect on accuracy~     of this test in this situation was not clearly investigated in recent studies.~      The purpose of this study would be to determine changes of screw stimulation thresholds~     under different range of neuromuscular blockade.Therefore, acceptable neuromuscular blockade~     threshold (determined by TOF test) acceptable for obtaining reliable screw stimulation test~     should be determined. Screw stimulation test may be performed when neuromuscular blockade is~     absent and compared to repeated screw stimulation test when neuromuscular blockade is~     present. Different levels of neuromuscular blockade may provide different results on screw~     stimulation test, so if difference is statistically significant, induced neuromuscular~     blockade level may be set as threshold value, acceptable for obtaining reliable testing~     results.~   "
58931|NCT02285816|"~     This research is being done because these viruses have been shown to shrink tumours in~     animals and human tumour samples by selectively killing cancer cells and creating an immune~     response to the tumour antigen contained in the viruses. This effect has been shown to~     increase when the AdMA3 virus is given first. It is not clear if this treatment will offer~     better results than standard treatment.~   "
58932|NCT02285803|"~     The aim of this study is to evaluate the added effect of tDCS to TRT within patients with~     chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real~     tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of~     therapy, at the end of the counselling and at last a follow-up visit will be planned after~     84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus~     Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement.~     Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis~     questionnaire and psychoacoustic measurements.~   "
58933|NCT02285790|"~     The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept,~     using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to~     surgical management of new primary basal cell carcinoma~   "
58934|NCT02285777|"~     This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the~     effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6~     month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as~     measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be~     invited at the time of their last study visit to participate in this extension study.~   "
58935|NCT02285764|"~     The purpose of this study is to investigate the potential effects of a modified carbohydrate~     nutritional product for obese pregnant women to reduce maternal glycemia.~   "
58936|NCT02285751|"~     High on treatment platelet reactivity is defined as a poor pharmacodynamic response to the~     administration of acetylsalicylic acid or clopidogrel. acetylsalicylic acid and clopidogrel~     are drugs commonly used to reduce platelet activity and prevent cardiovascular events. High~     on treatment platelet reactivity is associated with a higher cardiovascular event rate.~      Ticagrelor and prasugrel, like clopidogrel both P2Y12 inhibitors are effective in treating~     patients with High on treatment platelet reactivity to clopidogrel.~      Critically ill patients are a unique population with altered pharmacokinetic and~     pharmacodynamic properties. Gastrointestinal dysmotility with associated altered resorption~     and impaired microvascular function occur frequently in critically ill patients and may lead~     to altered resorption of orally administered drugs.~      The investigators will test a minimum of 100 patients treated with 100mg acetylsalicylic~     acid per os and 100 patients treated with 75mg clopidogrel per os to calculate the~     prevalence of high on treatment platelet reactivity.~      30 patients with high on treatment platelet reactivity to acetylsalicylic acid will be~     randomized to three new treatment groups. In the first group patients will receive 200mg~     acetylsalicylic acid per os, in the second group 100mg acetylsalicylic acid intravenously~     and in the third group 81mg chewable acetylsalicylic acid. Each group will contain 10~     patients. Pharmacokinetics and pharmacodynamics will be reassessed to evaluate the new~     treatment.~      36 patients with high on treatment platelet reactivity to clopidogrel will be randomized~     to receive either an additional loading dose of 600mg clopidogrel (n=24) or to continue~     normal treatment as a control group (n=12). Pharmacokinetics and pharmacodynamics will be~     reassessed and those patients, who are tested again to have high on treatment platelet~     reactivity in spite of the additional loading dose, will now be randomized to receive either~     ticagrelor or prasugrel. The investigators expect about six patients per group. The twelve~     patients in the control group will continue normal treatment (75mg/day) until the end of the~     study. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel will be assessed.~     Any patient, who is tested again with high on treatment platelet reactivity in spite of~     receiving prasugrel or ticagrelor, will be finally switched to the opposite drug and a final~     high on treatment platelet reactivity testing will be conducted.~      16 patients who are treated with 10mg prasugrel per os will be tested for HTPR and if~     positively tested will be switched to 2x90mg ticagrelor per os per day. Platelet reactivity~     will be reassessed to test whether switching the medication benefits the patients.~   "
59215|NCT02282137|"~     Single center, Prospective, Phase II expanded access clinical studies of 68Ga-PSMA~     (ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.~   "
58937|NCT02285738|"~     This research study examines the safety and feasibility of aspirin with or without~     Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots~     - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic~     (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as~     a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role~     in hemostasis, because it is predictive of thrombosis in cancer patients and because of~     promising preliminary data. We expect that sP-selectin levels will be elevated in patients~     before therapy with aspirin and/or statin, but that these levels will fall significantly~     during treatment, rise during the observation phase, and fall during the second study~     period. Patients who take part in the study have been diagnosed with a solid tumor cancer~     and are considered to be intermediate to high risk for VTE. The standard of care is to give~     chemotherapy for solid tumors and treat clots which develop using blood thinners.~   "
58938|NCT02285725|"~     This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the~     knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative~     intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma~     (PRP) and hyaluronic acid (HA).~   "
58939|NCT02285712|"~     Peripheral intravenous access is a major intervention in patients admitted to an intensive~     care unit. Systematically performed by nurses, it is also an essential intervention when the~     central venous access has to be removed. However, in the intensive care unit, patient~     centered-characteristics such as previous history of intravenous drug abuse, obesity,~     history of multiple vascular punctures or fluid overload most often affect the success rate~     of this procedure. For these patients, failure consequences are numerous: 1) delayed~     discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased~     incidence of catheter-related bloodstream infections. The use of ultrasound has gained~     increasing popularity particularly for obtaining central venous access. We hypothesize that,~     among trained nurses, ultrasound-guided peripheral venous access could represent an~     attractive alternative compared to the traditional anatomical method in order to increase~     the success rate.~   "
58940|NCT02285699|"~     This study will examine the gut microbiota and serum inflammatory markers in patients with~     Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the~     gut microbiota and cytokine levels following 12-weeks of treatment with Selective Serotonin~     Reuptake Inhibitors (SSRIs).~   "
58941|NCT02285686|"~     Troponins are sensitive and specific markers of cardiac injury. Critically ill patients~     frequently have elevated troponins. In this population, distinguishing patients with~     elevated troponins from those with myocardial infarction is difficult. However, troponin~     elevations on their own seem to be associated with an increased risk of death. The optimal~     treatment of patients with type 2 myocardial infarction or non ischemia related troponin~     elevations during critical illness is unclear. There are no trials in the ICU setting to~     guide management.~      This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care~     units. The objective of this pilot study is to evaluate the ability to perform a larger~     study, which will determine the prevalence, incidence and risk factors for elevated troponin~     values, how patients with elevated troponin values are treated as a baseline, and the~     incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact~     of these conditions and understanding current management will thereafter guide researchers~     and clinicians on the importance of carefully evaluating potential risk-modifying therapies.~   "
58942|NCT02285673|"~     Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin~     and characterized by progressive muscle degeneration. There is no cure for DMD at present~     but, there are several strategies under-researched for treatment of DMD such as steroid~     treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell~     theraphy and theraphy with drug that help to produce utrophin protein.~      The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem~     cells on DMD and understanding if wild type gene can be transfered to the patient.~   "
58943|NCT02285660|"~     The aim of high dose radiotherapy treatment is to deliver enough radiation to the tumour to~     kill all the cancer cells while at the same time giving a low dose of radiation to the~     normal parts of the body to reduce the side effects of treatment. This requires the cancer~     specialist to accurately identify the areas of cancer on a computed tomography (CT) scan.~     Positron emission tomography computed tomography (PETCT) scans use radioactive sugar that is~     injected into the patient. This sugar goes into cancer cells and shows up as a bright spot~     on the PET scan, allowing the doctors to see tumours more accurately. Some cancers move with~     breathing, for example lung, pancreas and oesophageal (or gullet) cancers. Fourdimensional~     CT scanning (4DCT) is a special type of CT scan that allows the motion of the tumour to be~     seen and measured accurately. This information can then be used to help ensure that the~     radiotherapy correctly treats the moving tumour.~      The aim of this study is to see if there are possible benefits to combining PET with 4DCT to~     get a 4D PETCT scan for tumours that move with breathing. This study is divided into three~     cancer types; lung, lower oesophagus and pancreatic cancer.~      First the investigators are going to test the use of 4D PETCT in the radiotherapy planning~     of these tumours to see if it helps the doctor to identify the cancer.~      Secondly, the investigators are going to see if the 4D PETCT helps to show areas within the~     cancer that are potentially more active. This might then allow us to target a higher dose to~     these areas, which could potentially improve the chance of controlling and curing the~     cancer. Patients' standard treatment will not be altered by participating in the study.~   "
58944|NCT02285647|"~     This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence~     study of orally- and IV-administered rolapitant in healthy male and female subjects.~   "
58989|NCT02285062|"~     To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,~     cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in~     patients who have previously untreated ABC type DLBCL.~   "
59006|NCT02284841|"~     This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain~     following the surgical removal of lower wisdom teeth. All participants will have two lower~     wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the~     patients' face for 60 minutes post-operatively, thus the patient being their own control.~   "
58945|NCT02285634|"~     Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly~     inciting 1 in 200 visits. They are most common in those less than ten and older than~     seventy, often occurring in the winter months secondary to dry indoor heating. Epistaxis is~     associated with elevated blood pressures, but it is controversial whether hypertension is~     actual a contributing cause.~      In non-life-threatening epistaxis, the first step in management is commonly the application~     of a topical vasoconstrictive medication. In many cases this will lead to cessation of the~     bleeding or facilitate the exam in those that continue to bleed. Frequently used medications~     include phenylephrine, oxymetazoline, and lidocaine with epinephrine.~      Classic teaching has been to avoid the use of these medications in patients with elevated~     blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical~     vasoconstrictors in this patient group with epistaxis severely limits the treatment options~     for a many patients given the association between the two conditions.~      Though universally taught, the actual effect of these agents on blood pressure remains~     unquantified. Studies investigating the prevention of nose bleeding during nasotracheal~     intubations suggest that the effect might be minor with little variation between agents.~      Clinical question:~      What is the effect of commonly used intranasal vasoconstrictors on blood pressure in~     volunteers without a history of hypertension.~   "
58946|NCT02285621|"~     Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10%~     will need a brace treatment during pubertal growth spurt. The design is made relatively~     corsets empirically, hence the relative efficiency of this treatment. Our team has developed~     innovative methods for design, optimization and computer aided manufacturing-based numerical~     simulation models customized to each patient, and a system of evaluation and adjustment of~     corsets. In this project, the investigators will evaluate the effectiveness of this platform~     customized treatment and demonstrate its clinical application~   "
58947|NCT02285608|"~     Investigators are doing this study to examine if a new personalized education program for~     patients with mood disorders (depression and bipolar disorders) will help them take their~     medications as prescribed by doctors. Investigators will teach patients about how, when and~     why it is important for them to take their medications as prescribed. Also, investigators~     will ask patients why they do not take medications as prescribed. Furthermore, investigators~     will examine whether our education program might save money if it prevents problems related~     to not taking medication.~   "
58948|NCT02285595|"~     A prospective, literature controlled, clinical study evaluating healing rates for the~     Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal~     therapy.~   "
58949|NCT02285582|"~     The rare histiocytic disorders (RHDs) are characterized by the infiltration of one or more~     organs by non-LCH histiocytes. They can range from localized disease that resolves~     spontaneously, to progressive disseminated forms that can be sometimes life-threatening.~     Since they are extremely rare, there is limited understanding of their causes and best~     treatment options. Physicians, patients and parents of children with RHDs frequently consult~     members of the Histiocyte Society regarding the best management of these disorders. Very~     often, no specific recommendation can be made due to the lack of prospective outcome data,~     or even large retrospective case series. The creation of an international rare histiocytic~     disorders registry (IRHDR) could facilitate a uniform diagnosis of the RHDs, as well as the~     collection and analysis of the clinical, epidemiological, treatment and survival data of~     patients with RHD. The registry may also lead to future therapeutic recommendations, provide~     a framework for future clinical trials and create excellent research opportunities.~   "
58950|NCT02285569|"~     During a caesarean section the blood pressure is usually measured every few minutes and it~     may fall too quickly to be detected in a timely fashion by this intermittent means. The~     monitor the Masimo Rainbow SET® (MRS) uses a peg attached to a finger to detect (amongst~     other things) the flow of blood through it. One of the measures it takes is called the Pleth~     Variability Index (PVI) which (unlike standard blood pressure measurement) it measures~     continuously. The investigators would like to try the MRS on patients to see if the PVI can~     be used to predict falls in blood pressure.~   "
58951|NCT02285556|"~     The purpose of this research is to inspire new medical ideas using brain image technology~     for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the~     addition damage.~   "
58952|NCT02285543|"~     To confirm the subgroup result from TPF(docetaxel, cisplatin and 5-fluorouracil )~     trial(NCT01542931)~   "
58953|NCT02285530|"~     The purpose of this study is to confirm the predictive value of GDF15 for TPF induction in~     cN0 patients with OSCC~   "
58954|NCT02285517|"~     This is a clinical trial study that compare two plastic surgery techniques in patients with~     third degree of burning and both techniques are used in all patients but in different areas~     of burning sites of the patients.~   "
58955|NCT02285504|"~     This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,~     PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe~     postpartum depression (PPD).~   "
58956|NCT02285491|"~     Local anesthetic will be injected into both angles of the rectus sheath incision in an~     attempt to block sensory nerves in this area that cause the sensation of pain from lscs~     wound.~   "
58957|NCT02285478|"~     Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination~     antiretroviral therapy for treatment of HIV-infected adults according to international~     guidelines. For children 3-12 years old, FDA has approved once daily dosing of~     darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved~     based on a modelling and simulation procedure by the company.~      This pharmacokinetic study is designed to validate the proposed dosing recommendation for~     once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.~   "
58958|NCT02285465|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     ascending multiple oral doses of ASP3700 in healthy subjects.~   "
58959|NCT02285452|"~     In integrative medicine wraps are applied for different indications. In this study the~     effects of thorax with ginger and mustard flour are investigated under standardized~     conditions. Heart rate variability, well being, warmth distribution and respiratory activity~     of healthy subjects will be measured.~   "
59007|NCT02284828|"~     Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral~     dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.~   "
58960|NCT02285439|"~     The main purpose of phase I studies in general is to determine the best dose (maximum~     tolerated dose) of a drug, and to find out the most common side effects. The main purpose~     of the phase I component of this study specifically is to determine the best dose of the~     experimental drug MEK162 and to find out whether the drug is safe in children and~     adolescents with tumors that have grown or come back despite standard therapy.~      Another purpose of this study is to measure the concentration of drug in the blood to help~     understand how much drug gets into the body and how quickly the drug is removed from the~     body. Another purpose of this study is to determine whether MEK162 turns off the Ras/Raf/MAP~     pathway as expected by measuring this pathway in blood cells. Finally, in this study, the~     investigators hope to start finding out whether or not MEK162 causes different types of~     tumors in children to shrink or stop growing.~      The main purpose of the phase II component of the study is to determine whether MEK162~     causes specific types of tumors in children and adolescents to shrink or stop growing. These~     specific types of tumors include low-grade gliomas, tumors in patients with a genetic~     condition called neurofibromatosis type 1, and other tumors thought to be caused by abnormal~     activation of the Ras/Raf/MEK molecular pathway.~      Another purpose of this study is for researchers to learn whether specific abnormalities in~     the DNA of tumors can help predict whether tumors will respond to MEK162.~   "
58961|NCT02285426|"~     Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways~     and pivotal for the diagnosis and staging of lung cancer. Further technological improvements~     have resulted in high definition (HD+) images and advanced image enhancement technique~     (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination~     with i-scan technology is superior to HD+WL (white light) for detecting endobronchial~     vascular changes. In this study we aim to correlate these vascular changes to histology and~     hypothesize that these vascular changes are related to (pre-) malignant changes and that the~     addition of i-scan is superior to HD+ WL.~   "
58962|NCT02285413|"~     This is an exploratory study and the primary objective is the immunogenicity and feasibility~     of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and~     clinical efficacy. This study will provide important data on the immunological efficacy of~     DC immunochemotherapy.~   "
58963|NCT02285400|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized~     by airflow limitation that is progressive and not fully reversible. Expiratory flow~     limitation (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and~     intrinsic positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased~     inspiratory muscle efforts and impaired central drive mechanical and ventilation coupling,~     which is an important mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe)~     can decrease inspiratory efforts and work of breathing, improve patient-ventilator synchrony~     in severe COPD patients with PEEPi and treated with mechanical ventilation. Nevertheless,~     the effects of CPAP/PEEPe level on respiratory mechanics, especially on central drive~     mechanical and ventilation coupling, still need further investigations.~      In the present study, about 40 patients with COPD will be recruited as research subjects.~     And the investigators aim to observe the changes in respiratory mechanics, central drive~     mechanics, central drive mechanical and ventilation coupling at different levels of CPAP.~     Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory~     mechanics and central drive during DPH, which may provide a reasonable basis for the~     clinical application of CPAP to COPD patients and the exploration of a new reasonable CPAP~     setting method.~   "
58964|NCT02285387|"~     Prospective randomized (rhythm control or rate control) Objective of study~        1. To analyze long term outcome of patients with acute stroke with atrial fibrillation~          according to the rhythm control~        2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with~          acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion,~          catheter ablation)~   "
58965|NCT02285374|"~     This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in~     the United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of~     the combination pill, Atripla® is a recommended firstline regimen for the treatment of Human~     Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also~     referred to as antiretroviral therapy.~      Toxicity is the most common reason for modification of firstline therapy. Central Nervous~     System (CNS) side effects such as difficulty with sleeping & bad dreams are common side~     effect of Efavirenz based therapy and is one of the most frequent reasons for switching or~     discontinuing highly active antiretroviral therapy.~      Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the~     treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared~     to Efavirenz in other clinical studies, where patients were starting HIV treatment for the~     first time, or switching from other agents.~      The purpose of the study is to investigate the benefits of switching away from Eefavirenz~     (in combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir~     in patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).~   "
58966|NCT02285361|"~     To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean~     patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)~   "
58967|NCT02285348|"~     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by~     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer~     susceptibility. The underlying mechanism and process of neurodegeneration leading to loss of~     cerebellar neurons and neurological function is largely unknown. Laboratory diagnostic~     approaches to neurodegeneration in A-T are hampered by sampling issues. It is dangerous,~     impractical, and not ethically to directly sample brain tissue by surgical biopsy. In~     contrast cerebrospinal fluid (CSF), a fluid that is in direct contact with brain tissue, is~     relatively easy to sample in a safe procedure (lumbar puncture). The aim of the proposal is~     to investigate oxidative stress, low grade inflammation and tissue break down in the brain~     of A-T patients by analyzing CSF. In addition the alterations in protein expression related~     to A-T will be quantified by liquid chromatography/mass spectrometry (LC/MS)-based proteomic~     analysis of CSF from healthy individuals and A-T patients to determine candidate proteins~     (new biomarkers) which relative expression levels could be used as surrogate marker of~     disease progression.~   "
58968|NCT02285335|"~     The purpose of the study is to evaluate the effect of GINST on human semen. The study is a~     pilot study, designed as open-label, prospective randomized clinical trial using GINST~     either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day),~     two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a~     dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax~     ginseng). Expected participants are to be male partners of female patients who visit~     infertility clinic at Severance hospital, whose total motile sperm count is more than~     0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood~     test, questionaires are planned to be performed 2 times, on the initial visit and after~     12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count,~     motility, morphology, total leukocyte count, total motile sperm count, further analysis~     including sperm chromatin assessment to examine the quality of sperm and malondialdehyde~     (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test~     will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH),~     total and free testosterone. Quality of life, sexual performance before and after taking~     GINST will be evaluated using questionaires.~   "
58969|NCT02285322|"~     Current guidelines for the clinical management of hypertension in adults recommend to~     achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what~     proportion of individuals identified with high blood pressure in primary care actually reach~     blood pressure control, what factors are associated with attainment of control and to what~     extent blood pressure control attainment is associated with cardiovascular diseases in a~     contemporary population of individuals diagnosed with high blood pressure.~      The aim of this study is to investigate the extent to which patients achieve blood pressure~     control and associated risk factors, time to attainment of blood pressure control and~     whether this time is associated with an increased risk of CVD onset, all-cause and~     cardiovascular disease and end-stage renal disease.~   "
58970|NCT02285309|"~     This observational clinical trial will investigate the following perioperative indices~     relating to cardiac surgery:~        1. The significance of measurements involving left heart relaxation (LV diastolic~          function) and its relation to outcome measures.~        2. The significance of measurements involving right heart relaxation function and itrs~          relation to outcome measures.~        3. The influence of drugs such as enoximone on these outcome measures.~   "
58971|NCT02285296|"~     Elderly cancer patients need more help from their relatives and for longer than young~     adults.~      Our hypothesis of research is that the needs and resources to help the couple  elderly~     patient/caregiver , are at least in part socially determined and that the implementation of~     a personalized support plan to help the caregiver (PSP) taking into account needs, resources~     and expectations of the primary caregiver in addition to those of elderly patients with~     cancer may partly correct inequalities. The PSP should allow a better management of cancer,~     a lesser burden for the caregiver and a better quality of life for both the caregiver and~     the patient.~   "
58972|NCT02285283|"~     The purpose of this randomized controlled double-blinded trial is to determine if the~     addition of an oral antifungal to typical post-operative medical therapy can prevent or~     reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic~     rhinosinusitis with nasal polyps (CRSwNP).~   "
58973|NCT02285270|"~     Brown adipose tissue is poorly understood fat that can metabolize glucose in order to~     generate heat. Since activated brown fat has a high metabolic rate, it is of great interest~     as a potential target to combat obesity. However, the signaling and control of brown fat~     metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown~     fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18~     FDG. We have recently shown in mice a striking circadian variation in brown fat metabolism~     as evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a~     potential circadian variation in brown fat activation in healthy humans.~   "
58974|NCT02285257|"~     The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan~     subdistrict in Beijing in mainland China).~   "
58975|NCT02285244|"~     This phase II trial studies how well sotrastaurin acetate works in treating patients with~     chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or~     Richter's transformation that has returned or that does not respond to treatment.~     Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
58976|NCT02285231|"~     In this double-blind, placebo-controlled study, subjects with prediabetes and type 2~     diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose:~     AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin,~     and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at~     baseline and after the 6-week intervention.~   "
58977|NCT02285218|"~     To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic~     fatty liver disease (NAFLD), diabetes, or dyslipidmia.~      To examine the association or effects of clinical and biochemical factors (lab results and~     medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with~     non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.~   "
58990|NCT02285049|"~     Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical~     presentation of a patient in each visit is not representative of the current disease status.~     Dermatologists are trying to integrate an evaluation process of each treatment visit~     regarding both clinical condition and life quality concern. The Urticaria Control Test is~     the key for a better treatment outcome in a routine management. To translate this~     questionnaire into Thai is essential in our subject of interest for offering local patients~     a higher well-being standard. The Thai-version test will encourage enhanced as well as~     impactful therapeutic options for Thai chronic urticaria patients.~   "
58991|NCT02285036|"~     A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety~     and immunogenicity demonstrated in the phase III trial in China. A large scale, double~     blind, randomized, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was~     conducted.~   "
59216|NCT02282124|"~     The aim of this study is to investigate the effectiveness of the program in patients after~     renal transplantation using a randomized controlled trial design. Physical, behavioural, and~     clinical outcomes will be measured at baseline before randomization then 8 and 12 months~     later.~   "
58978|NCT02285205|"~     Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist~     that decreases insulin resistance in the periphery and liver resulting in increased~     insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It~     demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison~     to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the~     only drug which is considered as an effective therapeutic agent for improving non-alcoholic~     fatty liver disease (NALFD) in type 2 diabetes (T2D).~      The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4~     study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on~     intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.~      Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet~     once daily) for 24 weeks.~      Primary endpoint is changes from baseline in controlled attenuation parameters (CAP)~     measured by transient elastography (fibroscan) after treatment with Lobeglitazone.~      Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated~     albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function~     parameters (AST, ALT, r-GT), and adverse events during the trial.~   "
58979|NCT02285192|"~     The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose~     (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us~     more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain~     cancer.~   "
58980|NCT02285179|"~     This study is designed as a phase 1 dose escalation study followed by a randomised phase II~     study. The study will be performed in three different centres: Addenbrooke & Cambridge~     university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron~     Hospital (Barcelona, Spain).~      Three to six patients will be followed for one completed cycle of therapy (28 days) and~     subsequent enrolment of new cohorts will be based on the safety assessment in that first~     cycle and the documentation of dose limiting toxicities. To determine the safety and~     efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032~     compared with tamoxifen alone.~   "
58981|NCT02285166|"~     The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events~     associated with long-term treatment with and without omega-3 fatty acid ethyl esters~     (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily~     medical practice.~   "
58982|NCT02285153|"~     Platelets play a central part not just in homeostasis and thrombosis as the primary effector~     cells, but they are also key cells in the regulation of the immunological response to~     various stressors. After activation, platelets release their granules which store different~     inflammatory mediators that induce coagulation, recruit further platelets, activate~     complement, attract neutrophils and leukocytes and regulate the vascular tone. Platelets~     activated by systemic inflammation and infection, may also contribute to the development of~     multiple organ failure. Thus, inhibition of platelet activation may have beneficial effects~     on critically ill patients.~      the investigators hypothesize that acetylsalicylic acid reduces the mortality of medical~     intensive care unit patients. In a retrospective study acetylsalicylic acid use was~     associated with a substantial reduction in a medical intensive care unit population (Winning~     et al., 2010).~      The investigators will conduct a randomized, double-blind study including 460 patients~     (2x230), who will be randomized to receive 100mg acetylsalicylic acid(daily, intravenous) or~     a placebo (0,9% sodium-choride solution) to assess whether acetylsalicylic acid reduces the~     mortality of medical intensive care unit patients.~      Main outcome criteria will be 28/90day-mortality. Furthermore the investigators will assess~     whether acetylsalicylic acid reduces the risk of suffering thromboembolic complications.~      Post-mortem examinations will be conducted in all patients who die in the course of the~     study.~      Furthermore we will assess bleeding rates, intensive care unit mortality and pharmacokinetic~     and pharmacodynamic properties of acetylsalicylic acid in the intensive care unit~     population.~   "
58983|NCT02285140|"~     There is clinical equipoise about the question of whether antibiotic prophylaxis should be~     given for a short period or an extended period of time as reflected by inconsistencies in~     major guidelines, current practices at Canadian centers, and as concluded in the three~     systematic reviews. There also is clinical equipoise on whether the addition of vancomycin~     to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of~     combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials~     such as infections with C. difficile or emergence of resistance, but may also reduce the~     incidence of s-SSIs. The objective of the eventual full scale study is to determine whether~     adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is~     as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is~     to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the~     adherence to the study protocol at each pilot site, the length of time to fill out the case~     report forms, and to get reliable estimates of event rates for sample size calculation for~     the main study~   "
58984|NCT02285127|"~     Is there a functional outcome difference when treating pertrochanteric fractures with a~     short or long cephalomedullary nail?~   "
58985|NCT02285114|"~     This study will evaluate the pharmacokinetics (PK), safety, and efficacy of~     emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents~     virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at~     least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor~     (NRTI) containing regimen.~   "
58986|NCT02285101|"~     The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as~     an infusion to treat patients who bear advanced solid tumors that are dependent on arginine~     (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have~     progressed after receiving approved or established therapies. This is a Phase 1 study;~     PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.~   "
58987|NCT02285088|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and~     pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects~     with sickle cell disease (SCD).~   "
60301|NCT02267902|"~     The objectives of this study are to evaluate the absolute bioavailability, and absorption~     and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral~     and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be~     evaluated.~   "
58992|NCT02285023|"~     In the majority of patients with the chronic urticaria, the etiology is unclear, leading to~     difficulties in treatment and high rates of recurrence. According to the International~     EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of~     Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network~     (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in~     Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management~     is the key for a better treatment outcome. To translate this questionnaire into Thai is~     essential in our subject of interest in order to effectively apply it to local patients. The~     Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options~     for Thai chronic urticaria patients.~   "
58993|NCT02285010|"~     This study aims to compare the effect of pre-operative oral pregabalin on post operative~     morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.~   "
58994|NCT02284997|"~     Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver~     oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears.~     The meibomian glands may become obstructed due to change in meibum quality. When meibum~     thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear~     film. The blockage of the glands is the primary cause of meibomian gland dysfunction (MGD),~     and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical~     treatment for MGD is a procedure called warm compresses. It is a combination of applying~     heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the~     gland openings, and allow oils to flow normally onto the tear film once again. One way to~     apply heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40~     seconds under full power, and is placed over the closed eyes for approximately 10 minutes.~     The eyes are gently massaged afterwards.~      The purpose of this study is to determine how effective the EyeBag is at improving MGD and~     dry eye symptoms.~   "
58995|NCT02284984|"~     The present study investigates the potential of a new therapeutic approach in lupus~     nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the~     study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to~     evaluate clinical improvement and assess the safety and feasibility of long-term B-cell~     depletion.~   "
58996|NCT02284971|"~     This study evaluates the combination of stereotactic body radiation therapy (SBRT) and~     CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized~     to one of three arms to receive SBRT prior to, after, or in conjunction with the first dose~     of CDX-1127.~   "
58997|NCT02284958|"~     This study will investigate if a 12-week, individually-tailored walking program, using~     pedometers will be a more clinically and cost-effective option for the management of chronic~     low back pain than standardized advice and education.~   "
58998|NCT02284945|"~     Spread of cancer to the spinal column is a growing problem in patients with cancer. It can~     cause a number of problems including pain, instability and neurologic problems. If left~     untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of~     treatment is to help with pain and to reduce the risk of these neurological problems. This~     treatment has traditionally been radiotherapy to the spine. Surgery has always meant large~     open operations with a long recovery time and significant risk of complications. There has~     been new technology that has allowed less invasive operations to take place to stabilise the~     spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the~     spinal cord. These techniques are called 'minimally invasive' and include surgical~     techniques such as cement augmentation and percutaneous instrumentation.~      The aim of this study is to compare traditional open operations with these new minimally~     invasive techniques to see if they do result in reduced complications and quicker recovery~     in addition to achieving the goals of surgery.~   "
58999|NCT02284932|"~     Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most~     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to~     poor functional status and premature mortality.~      One prevailing hypothesis stipulates that the deterioration in muscle structure and function~     during COPD results from a spillover of inflammatory mediators from the lungs to the~     systemic circulation and then to the muscles.~   "
59000|NCT02284919|"~     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate~     sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational~     radiotracer [18F]ISO-1.~   "
59001|NCT02284906|"~     The purpose of this study is to evaluate the effect of pioglitazone at 24 months compared~     with placebo on cognitive decline in high-risk participants who have completed the~     AD-4833/TOMM40_301 study [NCT01931566] with an adjudicated diagnosis of mild cognitive~     impairment (MCI) due to Alzheimer's Disease (AD).~   "
59002|NCT02284893|"~     A combination of saxagliptin and dapagliflozin added concurrently to metformin in~     combination with diet and exercise is superior to sitagliptin added to metformin in~     combination with diet and exercise in reducing mean HbA1c over a treatment period of 26~     weeks.~   "
59003|NCT02284880|"~     Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory~     blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female~     subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API)~     sources of eslicarbazepine acetate (ESL)~   "
59004|NCT02284867|"~     Research question:~      Population of study: women diagnosed as term pregnancy in labor (control) and the other~     group diagnosed as preterm labor (cases).~      Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells~     has a role in initiation of preterm labor.~      Research hypothesis:~      • Are uterine Natural Killer cells involved in the initiation of preterm labor ?~      Medical Application:~      • Possibility of prediction of preterm labor by assessment of Natural killer cells as well~     as preventing preterm labor by suppressing their activity .~   "
59005|NCT02284854|"~     Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the~     effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ~     pharmacokinetics.~   "
59254|NCT02281578|"~     The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial~     effectiveness of a community-based combination HIV prevention intervention among bar-based~     female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase~     III RCT as warranted.~   "
59008|NCT02284815|"~     Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's~     regenerative capacity. The patients' beta-cell capacity increases shortly after onset when~     glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells~     and therefore shorter remission; but the expansion potential is larger the younger the child~     is. The problem with the majority of intervention studies is the many and serious side~     effects, or a quite marginal effect on the residual beta-cell function. However, in animals~     that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free~     diet increases the number of regulatory T cells in Peyer's patches, affect the composition~     of intestinal microflora and modify the balance between pro and anti-inflammatory cytokines~     in T cells. Therefore, the aim of our study is to prolong the remission phase by introducing~     a gluten-free diet intervention to children at T1D onset.~   "
59009|NCT02284802|"~     Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and~     tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times,~     guiding optical biopsies in real time. Confocal endomicroscopy represents technique that~     combines conventional white light image with the confocal microscope probe, thereby allowing~     examination of the surface epithelium in vivo and histological diagnosis during endoscopy.~     Among the applications already established for its use, stand out diagnosis of Barrett's~     esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of~     hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients~     with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still~     detect molecular changes effectively improving the endoscopic diagnosis. This pilot project~     consists of 07 subprojects which the technology of confocal endomicroscopia will be~     evaluated and compared with the histological results of biopsy or surgical specimens:~      1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial~     esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial~     esophageal squamous cell carcinoma in patients with head and neck cancer by confocal~     endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in~     patients with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the~     gastric mucosa of patients with familial history of gastric cancer 5 Biliary Strictures:~     differential diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic~     neoplasms of the pancreas 7 Contribution of confocal endomicroscopy for the differential~     diagnosis of colorectal polyps The project aims to deploy the structure of the Confocal~     endomicroscopy Endoscopy ICESP, for performing in vivo histological examinations of the~     digestive tract, biliary tract and pancreas. All research groups involved in the early~     detection of tumors of the esophagus, stomach, biliary tract, pancreas, colon and rectum may~     benefit from the implementation of this methodology.~   "
59010|NCT02284789|"~     To obtain evidence of content validity and reliability of the Colorado Adult Joint~     Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use~     in a population of adults with moderate to severe hemophilia A treated with coagulation~     factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.~   "
59011|NCT02284776|"~     The goal of this study is to assess the effect of a therapeutic education program in~     addition of a hydrotherapeutic cure on obese patients.~      The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a~     dietary follow-up, a physical activities program, working group.~   "
59012|NCT02284763|"~     The aim of this study was to investigate the relationship between the end-tidal carbon~     dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the~     pharmacodynamic relationship between EtCO2 and rSO2.~   "
59013|NCT02284750|"~     The purpose of this study is to establish the optimal strategy for stenting in coronary~     bifurcation lesion.~   "
59014|NCT02284737|"~     Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of~     progressive and severe right ventricular failure. Target drugs are reported to be associated~     with significant improvement of clinical outcome for PAH patients. However, previous studies~     using those target drugs focused on the change of 6-minute walk distance (6MWD) and or~     hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical~     worsening, TTCW), benefits from targets for PAH patients are not clear. We previously~     reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH~     who were unresponsive to target drugs. However, there is a lack of a randomized study to~     identify the effect of PADN on PAH.~   "
59015|NCT02284724|"~     To examine for differences in contraction thickness of the transversus abdominis muscle in~     symptomatic subjects with mechanical lower back pain following the application of dry~     needling to the lumbar multifidus muscles.~   "
59016|NCT02284711|"~     Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a~     significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines~     therefore now recommend systematically associating prophylactic salpingectomy to benign~     hysterectomy. The principal objective of the present study is to assess the impact of~     salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the~     Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to~     compare ovarian reserve results between two coagulation techniques used in salpingectomy:~     bipolar electric energy versus ultrasound.~      The study design is single-center, prospective, before-and-after, with open randomization~     between two groups defined by coagulation technique.~   "
59017|NCT02284698|"~     A community-randomized trial comparing villages randomized to receive an intervention~     consisting of a trained community health volunteer who brings patients to the nearest Vision~     Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to~     control villages receiving no additional intervention. The primary outcome of corneal ulcer~     will be measured by baseline and annual population-based census performed in both~     intervention and control villages by masked examiners from baseline to 24 months. Each~     resident in the village will be asked about their ocular history and, if suspected of having~     a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will~     occur, coinciding with the end of the harvest season. In villages randomized to~     intervention, an active promotion campaign will be undertaken to urge residents to notify~     the village eye health worker within 24 hours of ocular trauma. In control villages,~     abrasions and ulcers will be treated if they present to a clinic or are found during the~     annual monitoring visits, but active promotion of corneal abrasion care will not be offered.~   "
59018|NCT02284685|"~     Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S.~     college campuses, an estimated 80% students with clinically significant ED symptoms do not~     receive treatment. There are likely more than one million students whose EDs go untreated in~     any given year. Left untreated EDs typically become more severe and refractory to treatment.~     Given the impact of EDs on mental and physical health and the connection therein with~     social, academic, and economic outcomes, an effective intervention to increase rates of~     treatment utilization would have broad societal effects extending well beyond the campus~     setting. This study is an online intervention designed to identify and increase help-seeking~     among undergraduates with previously undiagnosed/untreated EDs.~   "
59019|NCT02284672|"~     Propofol frequently used as an inducting medication for insertion Laryngeal mask~     airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and~     also result in cardiovascular suppression under enough amount. Dexmedetomidine is a~     selective alplh2 receptor agonist with analgesic and sedative effects but sparing~     respiratory function. Therefore propofol combined with dexmedetomidine induction could be~     more effective in preserve respiration under same condition for LMA insertion than propofol~     alone. In this study, the investigators investigate the clinical dose of propofol for LMA~     insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.~   "
59020|NCT02284659|"~     Objective: The aim of this study is to evaluate the FES effect on erectile function in men~     with erectile dysfunction.~      Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.~   "
59021|NCT02284646|"~     Purpose: to assess the efficacy of a physical training program in patients with ankylosing~     spondylitis (AS) in a randomized controlled study~   "
59022|NCT02284633|"~     In non-small celled lung cancer (NSCLC) 10-15% of the patients harbor a mutation in the~     tumor's epidermal growth factor receptor (EGFR M+). This receptor is the target for~     treatment with erlotinib. Identification of EGFR M+ is done on a biopsy, which can be~     difficult to retrieve. A new blood based test identifies EGFR M+ in plasma, which makes it~     possible to monitor the level of EGFR M+ in the patient's blood during treatment. This~     enables both a closer monitoring of the treatment with erlotinib and a closer study of the~     resistance mechanisms that almost inevitably develop during treatment. A pilot study~     demonstrated that the quantity of EGFR M+ in plasma correlates to the response to treatment~     and might be used to predict disease progression.~      Patients with disseminated EGFR M+ NSCLC referred to a participating oncology department may~     be enrolled in the project. The investigators expect to include 200 patients over a two-year~     period. Patients will receive standard lines of treatment and follow up. Standard 1st line~     treatment for these patients is erlotinib. A biopsy and blood sample will be retrieved~     before treatment with is initiated. The patient will be monitored prospectively with blood~     samples every 3rd-6th week both during erlotinib treatment, subsequent lines of treatment~     and treatment intermissions. The blood samples are analyzed for subtypes of EGFR M+ both~     sensitizing mutations and mutations known to drive resistance to erlotinib treatment. In the~     event of occurring resistance mutations or unexpected increase in quantity of sensitizing~     mutations clinical action will be taken; initially in the form of additional scans searching~     for signs of disease progression. Clinical data will be retrieved from the patient's medical~     journal. Patients are followed until death or at least 24 months after inclusion. Any excess~     biological material will be stored for up to 15 years in a bio bank for future research~     purposes.~      We expect our results to validate the use of EGFR M+ detection and quantification via blood~     samples in a clinically relevant setting. The investigators expect earlier identification of~     disease progression to allow more cases of local treatment thus - hopefully - increasing the~     progression free survival. Continued blood monitoring in subsequent lines of treatment and~     treatment intermissions will add to our knowledge of the nature of EGFR M+ NSCLC. The~     sampling of biological material allows us to further investigate the biology of resistance.~   "
59023|NCT02284620|"~     Post-operative pain after total knee arthroplasty is usually severe and impair the~     functional recovery of operated joints.The purpose of this study is to determine whether~     post-operative continuous femoral nerve block analgesia is superior to local wound~     infiltration combined with intravenous patient controlled analgesia in improving joint~     function and reducing the incidence of chronic post-surgical pain (CPSP).~   "
59024|NCT02284607|"~     This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as~     compared to placebo when administered to healthy volunteers.~   "
59025|NCT02284594|"~     Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations~     annually. While vaccination is the cornerstone of preventing influenza infection,~     vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text~     message reminders have been used successfully for improving influenza vaccination for~     children. This study will assess the use of text messaging to improve influenza vaccination~     coverage rates in a largely minority, publicly insured adult population. We will also assess~     if the patient having received a text message makes the patient more likely to accept~     vaccination when their provider has received in electronic alert regarding need for~     influenza vaccination in the electronic health record.~   "
59026|NCT02284581|"~     Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast~     cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about~     13.000 women die every year for this disease . About 6-7% of breast cancer patients are~     metastatic at diagnosis , while the majority of patients with stage IV has a previous~     history of breast cancer that has already been treated. According to various prognostic~     factors (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2~     status), in the worst-case scenario, more than 30% of node-negative breast cancer patients~     and more than 70% of node-positive patients relapse2.~      The evolution of metastatic breast cancer has changed considerably in the last years with~     the approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis~     of metastatic breast cancer patients was improved significantly from 1970's to 2000 with a~     median survival of 15 months in the early 1970's compared with 60 months in the last 1990's.~      This significant survival gain was obtained with introduction of new drugs as hormonal,~     chemotherapeutic and biological agents. The greater availability of drugs has led to an~     increase in number of lines of treatment receiving by metastatic breast cancer patients.~     However, there are few published data on actual duration of metastatic breast cancer~     treatments. Moreover, there is no evidence to support a real impact on survival of~     treatments beyond the second-third line.~      Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated~     with chemotherapy showed that tumor subtype is associated with the duration and number of~     lines of chemotherapy (for example HER positive versus triple-negative patients) .~   "
59027|NCT02284568|"~     This Phase 2 study is intended to serve as a proof of concept for potential treatment with~     laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of~     laquinimod in this population.~   "
59028|NCT02284555|"~     This study will assess the nasal eradication of SA in healthy subjects following treatment~     with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth~     enriched culture microbial assay. The sensitivities of broth enrichment and plating assay~     methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will~     also be assessed.~   "
59057|NCT02283151|"~     The study was designed to investigate the effects of a very low carbohydrate diet (VLCD)~     intervention on weight control in overweight/obese patients in China.All the subjects were~     randomly assigned to experiment group and control group. The experimental group was given~     individual instructions on how to follow the VLCD (very low carbohydrate diet). The control~     group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed~     in the traditional Chinese style with an initial target for a total energy intake of 1200~     kcal/d (5021 kJ/d).~   "
59029|NCT02284542|"~     The primary objective is to demonstrate the safety and efficacy of a non-awake implantation~     method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation~     method (with local anesthesia and patient feedback).This is a post-market, prospective,~     multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50~     patients will be implanted from up to 4 active sites, coordinated by a single lead~     investigator.~      Patients who have had a successful SCS trial and are indicated for permanent implantation~     will be approached to participate in this study prior to permanent implantation. Patients~     will be recruited and enrolled by physicians at any one of the involved sites. Each~     Investigator will only use one method (awake or non-awake) according to his/her typical~     practice. Patients will receive treatment from their enrolling physician.~   "
59030|NCT02284529|"~     Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin),~     fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ~     colorectal cancer.~      Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia)~     in the end of study.~      Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia,~     nausea, diarrhea vomiting over the 12 weeks.~      Safety will be evaluated including vital signs are recorded at all visits.~   "
59031|NCT02284516|"~     Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a~     recent history of artificial tear use.~   "
59032|NCT02284503|"~     This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring~     efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.~   "
59033|NCT02284490|"~     This phase II trial is studying how well pemetrexed disodium works in treating patients with~     Lung Adenocarcinoma With Brain Metastases~   "
59034|NCT02284477|"~     -  Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent.~        -  Phthalate is mainly used as PVC plasticizer and easily found in commonly used products~          such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc.~          Especially, PVC blood bag used for blood transfusion have been reported to have high~          level of phthalate concentration.~        -  Previous studies reported that urinary concentration of phthalate metabolites and HOMA~          (Homeostatic model assessment, indicator of insulin resistance) has positive~          association.~        -  Previous studies also reported negative associations between urinary phthalate~          concentration and pulmonary function.~        -  Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate~          containing package material is expected to be one of the major contributor for~          phthalate exposure.~        -  In this present trial, the investigators are to examine whether increased phthalate~          exposure by consuming beverage stored in PVC containing packing materials actually~          effect insulin resistance, pulmonary function and epigenetic feature.~        -  For this aim, the investigators will conduct a cross-over trial.~   "
59035|NCT02284464|"~     Steroids are one of the pillars of immunosuppression for kidney transplant patients but~     their use is associated with a high rate of complications. Withdrawal of steroids reduces~     some metabolic and cardiovascular complications, but it may increase the risk of acute~     rejection. However, little is known about whether steroid withdrawal is associated with the~     generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and~     clinical and histological data. The aim of this study is to compare the incidence of de novo~     anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months~     after the transplantation as compared with patients who continue with steroids. The~     hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in~     stable kidney transplant patients~   "
59036|NCT02284451|"~     The Centers for Disease Control and Prevention (CDC) recommends that all patients should~     receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing~     encounter. However, for busy emergency departments (EDs), delivering information orally is a~     barrier to HIV testing, and written brochures likely are not useful for those with lower~     health or general literacy. Videos might be as or more efficacious than orally-delivered~     information in improving HIV/AIDS and HIV testing knowledge, particularly for those with~     lower health literacy skills. However, the resources required to show videos might limit~     their use in EDs. Pictorial brochures are a promising alternative, but are of unknown~     efficacy.~      The objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information~     should be delivered by a video or pictorial brochure to emergency department (ED) patients~     to improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if~     longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for~     those who watch a video or review a pictorial brochure; (3) determine if short-term~     improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after~     watching a video or reviewing a pictorial brochure for those with lower health literacy, and~     if improvement and retention also varies by language spoken (English or Spanish); and (4) if~     willingness to be tested again in one year is greater for those who watch the video or~     review the pictorial brochure, and if this willingness also varies by health literacy level~     and language spoken.~   "
59037|NCT02284438|"~     Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding~     formation and structure of the biofilm formed on those ETTs.~      Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be~     examined.~      Findings from electron microscopy (EM) and microbiology will be analyzed and compared in~     respect to the three materials.~   "
59038|NCT02284425|"~     This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety~     and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.~   "
59058|NCT02283138|"~     The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance~     index in preterm fetuses and correlating the results with postnatal respiratory distress of~     the preterm neonates.~   "
59059|NCT02282098|"~     The purpose of this study is to determine the feasibility of performing a randomized~     controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at~     reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).~   "
59255|NCT02281565|"~     The study evaluates the knowledge, attitude and practice about blood donation among medical~     students and medical staff in Poland.~   "
59039|NCT02284412|"~     The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative~     pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral~     nerve/muscle to assess the patients' breathing capability at the end of surgery. It is~     possible that respiratory complications after surgery (e.g. desaturation and atelectasis)~     are related to the lack of diaphragm activity.~      A previous trial by our study group links the use of sugammadex, a novel selective relaxant~     binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm~     electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making~     nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular~     junctions, instead of increasing the amount of acetylcholine (like neostigmine does),~     sugammadex will result in a better neuromuscular coupling. This may have its subsequent~     effects on the central control of breathing, influencing the balance between intercostal and~     diaphragm activity.~      The investigators now propose a study in rats, where the investigators will use Functional~     Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to~     assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The~     images obtained through micro-CT scans allow us to accurately reconstruct airway morphology~     in the free-breathing rat. It will provide us with new insights into breathing physiology~     after reversal of neuromuscular blockade.~   "
59040|NCT02284399|"~     Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the~     Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be~     retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be~     compared to a control group of pregnant women in those same practices undergoing prenatal~     testing during the months of January 2010-July 2010.~   "
59041|NCT02284386|"~     This is a Phase 4, multicenter, open-label study designed to characterize the~     pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects~     undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride~     (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.~   "
59042|NCT02284373|"~     The purpose of this study is to evaluate the effect of pneumatic compression in improving~     symptoms, quality of life and wound healing in patients with venous ulcers and/or~     lymphedema.~   "
59043|NCT02284360|"~     This is a prospective, single center, randomized, double-blinded, placebo-controlled,~     exploratory phase I clinical trial in healthy male subjects to investigate the safety and~     tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of~     APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound~     healing of APOSEC™.~   "
59044|NCT02284347|"~     This is a prospective, non-randomized, single-arm study designed to assess the safety and~     device performance of the NuVent navigation-guided balloon system for use in subjects with~     scarred, granulated, or previously surgically altered tissue (revision).~   "
59045|NCT02284334|"~     The investigators are conducting a research study on nutrition in mitochondrial disease. The~     investigators are interested in the kind of carbohydrates that people eat. Carbohydrates are~     an important source of energy. Certain kinds of carbohydrates tend to raise blood sugar more~     in healthy people, and others tend to raise blood sugar less in healthy people. The~     investigators would like to know if by eating the right type of carbohydrate, people with~     mitochondrial disease can avoid high lactate levels, high blood sugar levels, and, later,~     low blood sugars.~      In this study, this question will be answered by finding out how people with mitochondrial~     disease respond to two different test meals containing different kinds of carbohydrates.~     Neither participants nor the investigators will know which kind of test meal participants~     are eating.~   "
59046|NCT02283294|"~     The purpose of this study is to evaluate if Apixaban will decrease the complication of~     having another stroke for people who have atrial fibrillation if initiated earlier than~     standard of care.~   "
59047|NCT02283281|"~     Clinical evidence about the effects of cannabis in a perioperative setting or for the~     management of acute pain is rather scarce, mostly consisting of case report-based opinions~     on adverse events during or after general anesthesia after smoking cannabis, experimental~     pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages~     and routes of administration. It is difficult to draw strong conclusions from the available~     evidence, that may seem sometimes even contradictory, mainly due -the investigators believe-~     to the many sources of variability in the study designs (e.g.: heterogeneity of the study~     samples, underpowered, unblinding, lack of randomization, timing of the therapeutic~     intervention, different experimental pain models, inclusion of different kind of surgical~     pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is~     that cannabis and cannabinoids may have a beneficial role in the management of acute~     post-operative pain and nausea, at least for a selected group of patients and through an~     appropriate therapeutic intervention.~      Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate~     the issue of perioperative cannabis use through a sufficiently powered and controlled~     clinical trial. Some of cannabis effects such as sedation, bronchodilation, dryness of~     respiratory secretions, vein dilation, and increase of heart rater without producing~     hypertension, make of it an attractive option for pre-medication; while its antiemetic~     properties and its analgesic potential without causing respiratory depression may be~     profitable for the post-operative period.~      Nabiximols seem to be most suitable to our investigation. The co-administration of~     tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic~     benefits with an attenuation of adverse effects. The investigators expect to obtain less~     sedation, milder high, lower incidence of anxiety, tachycardia, and hyperalgesia, as~     compared with THC-only acute pain trials.~   "
59048|NCT02283268|"~     The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand~     factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in~     adult patients with hereditary severe von Willebrand disease (VWD).~   "
59060|NCT02282085|"~     This study compares aripiprazole once-monthly injection to standard of care oral~     antipsychotic medication in non-adherent outpatients with schizophrenia to see which~     treatment helps people take their medicine more regularly and have more positive outcomes.~      It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole~     once-monthly will be more likely to respond and have lower symptom severity over 3 months of~     treatment than those receiving standard of care oral antipsychotics.~   "
59061|NCT02282072|"~     The purpose of this study is to verify efficacy and safety of a bilateral deep brain~     stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid~     addiction.~   "
59062|NCT02284308|"~     There is no detailed information available on benefits and harms of intensified treatment~     with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to~     distinguish the subgroup of fit patients from frail patients.~   "
59049|NCT02283255|"~     Introduction: Different variations of the Fontan operation has been used to treat complex~     cardiac anomalies with a single functional ventricle. This procedure has substantially~     improved quality of life and survival in patients with these complex cardiac anomalies.~     However, the cardiovascular and pulmonary functioning as well as skeletal muscle alterations~     that can explain the exercise intolerance in these patients is still poorly understood.~      Objectives: 1) To evaluate effects of different exercise programs on adolescents and adults~     with Fontan circulation.~      Methods: A long-term randomized clinical study that will include 60 patients between 12 and~     30 years, submitted to total cavopulmonary connection for at least 5 years post operative at~     the Heart Institute, University of São Paulo Medical School. The patients will be divided~     into four groups: 1) Exercise training with aerobic exercise + lower and upper limb strength~     exercise (GTF-I); 2) Respiratory training with respiratory muscle exercise (GTF-II); 3)~     Exercise training with aerobic exercise + lower and upper limb strength exercise +~     Respiratory training with respiratory muscle exercise (GTF-III); and A non-exercise group as~     control group (GNTF-IV). The patients will be revaluated after the 4-month period of~     intervention.~      Expected Outcomes: The investigators expect to demonstrate that exercise training and~     respiratory training can substantially improve the cardiovascular and pulmonary responses~     and skeletal muscle system in patients with univentricular circulation. In addition, the~     investigators wil test the hypothesis that the effects of exercise training associated with~     respiratory training on cardiovascular and pulmonary responses and skeletal muscle system~     may be greater than exercise training or respiratory training alone.~   "
59050|NCT02283242|"~     It is recognized that inflammation can be modulated by cholinergic stimulation and that~     galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action,~     has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement~     in tissue insulin resistance in animal models. Galantamine is a safe drug that is used to~     treat alzheimer disease.Galantamine treatments of patients with the metabolic syndrome may~     represent a significant advance in management of this disease. This study aims to~     investigate the effects of galantamine on inflammatory markers, as well as on abdominal~     visceral and epicardial fat and oxidative stress in patients with metabolic syndrome. This~     is a pioneering study that will include expert support. The enrolling of subjects will have~     continuous monitoring throughout the period of treatment. The study is a double blind~     randomized prospective study with 60 patients with metabolic syndrome, to be randomized at~     ratio of 1: 1 placebo and galantamine. The dose of galanthamine is the standard clinically~     approved (8 and 16 mg). The tracking method include metabolic analysis, inflammatory and~     oxidative stress markers, hemodynamic evaluation with hear rate variability (sympatho vagal~     modulation) before, during and after treatment. Computerized tomography assessment of~     visceral abdominal and epicardial fat before and after treatment will be performed.~   "
59051|NCT02283229|"~     Prospective randomized clinical interventional trial after birth in maternity ward, and~     follow up to 8-9 years of age.~      Hypothesis: Preventive handling and caring advices to parents of newborns decrease~     craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample~     size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a~     power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and~     appearances of occlusal defects are followed up to 9 years. 50 preterm infants can~     participate without intervention.~   "
59052|NCT02283216|"~     The purpose of the study is to investigate different stimulation parameters for a new~     noninvasive approach for modulating the brain that could potentially be beneficial for~     decreasing tinnitus perception. The new approach is called Multimodal Synchronization~     Therapy (mSync). mSync uses a combination of acoustic stimulation played through headphones~     and low levels of electrical current delivered via electrodes placed on the surface of~     different body regions. The timing interval between the acoustic and body stimulation is~     varied in order to cause different types of changes in the brain. In addition to acoustic~     and body stimulation, noninvasive cortical stimulation will also be presented as part of~     mSync to attempt to further modulate or decrease the tinnitus percept. Cortical stimulation~     will be performed by placing a magnetic coil over a spot on the head and sending a brief~     magnetic pulse that can travel through the skin and bone to create electrical current inside~     the head. For this study, different body locations as well as specific timing intervals~     among acoustic, body, and cortical stimulation will be investigated to identify appropriate~     parameters that can modulate and potentially decrease tinnitus perception. Different mSync~     parameters will be investigated across multiple testing sessions (up to 16 weekly sessions)~     and the tinnitus percept will be closely monitored throughout the study.~   "
59053|NCT02283203|"~     The efficacy of intravenous paracetamol has never been compared with other drugs for the~     management of fever due to infections. Available data come from clinical studies conducted~     in healthy volunteers subject to experimental endotoxemia. The present study compares the~     efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of~     infectious origin.~   "
59054|NCT02283190|"~     Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6~     doses MWF over a period of 2 weeks to 9 patients (as described below and in the following~     schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation~     studies including fibrinogen will be measured and reviewed before each asparaginase dose.~     Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the~     discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase~     or direct bilirubin above normal range.~   "
59055|NCT02283177|"~     This pilot study is designed to evaluate the safety and tolerability of oral crenolanib~     besylate given sequentially during standard induction and consolidation chemotherapy in~     patients with newly diagnosed AML with FLT3 activating mutations.~   "
59056|NCT02283164|"~     The goal of this research is to evaluate the efficacy of an audit and feedback intervention~     to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in~     the ambulatory oncology setting.~   "
59107|NCT02283723|"~     TAPESTRY is a delayed intervention pragmatic randomized control trial promoting~     interprofessional team collaboration, facilitating connection to the community through~     system navigation and trained community volunteers, enhancing communication and improving~     care through the use of technology to better understand and assist older adult patients in~     achieving their health goals and to enable them to have optimal aging.~   "
59063|NCT02284295|"~     The objective of this study is to investigate molecular, cytological and genetic features of~     occupational chronic obstructive pulmonary disease (COPD) in conditions of different~     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and~     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar~     lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470~     transforming growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP)~     gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine~     receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed~     to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between~     genotype and phenotype characteristics, such as an inflammation activity, assessed by~     C-reactive protein (hsCRP) and tumor necrosis factor alpha (TNF α) serum concentration, in~     different occupational COPD groups will be studied. The hypothesis is that the mechanisms~     underlying disease development and progression are different due to environmental risk~     factor that reflex in differs in disease attributes - molecular biomarkers, cytology results~     and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in~     smokers therefore COPD can be subdivided into ecological phenotypes according to~     environmental risk factor.~   "
59064|NCT02284282|"~     The objective of this study is to determine if a single spinal shot of morphine can decrease~     post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker~     recovery after surgery.~   "
59065|NCT02284269|"~     The purpose of this study is to integrate the post-marketing surveillances data (Specified~     use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in~     Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical~     practice conditions.~      In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are~     enrolled. A total of 18000 patients are assessed in the meta-analysis.~   "
59066|NCT02284256|"~     The primary objective of the study is to demonstrate the non-inferiority or superiority of~     Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding~     with conventional surgical techniques is ineffective or impractical.~   "
59067|NCT02284243|"~     The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative~     Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference~     over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following~     unilateral bunionectomy.~   "
59068|NCT02284230|"~     The present study will examine the effects of liraglutide treatment during 26 weeks on~     several cardiovascular risk factors in patients with prediabetes and end-stage renal disease~     (ESRD). The primary objective is to determine the efficacy of the treatment on glucose~     tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives~     include various clinical and biochemical cardiovascular and safety parameters.~      We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic~     patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate~     other cardiovascular risk factors.~   "
59069|NCT02284217|"~     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.~     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's~     head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and~     accurately monitor ICP with minimal discomfort to patients, and provide information about~     normal or elevated ICP levels to the physicians.~      The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive~     ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)~   "
59070|NCT02284204|"~     There is still extensive debate on the best method of controlling the behavior of preschool~     children during dental treatment. Protective stabilization, moderate sedation and general~     anesthesia are advanced behavior control techniques indicated for the dental treatment of~     early childhood caries and offer advantages and disadvantages during the procedure or~     immediately after. Many children with early childhood caries require invasive dental~     treatment. According to the final report of a large epidemiological survey on the oral~     condition of Brazilians, five-year-old children had an average of 2.43 primary teeth with~     caries and fewer than 20% of these had been treated in 2010. This disease also remains a~     public health problem in most developed countries; 19.5% of 2-5-year-old American children~     have untreated cavities.~      There is, however, a lack of the ideal sedative. Such drugs must, on the one hand, control~     the behavior of integral form, provide amnesia, minimizing physical discomfort, distress and~     pain, and, on the other, safeguard security, with minimal effect on the cardio-respiratory~     function, minimizing the occurrence of adverse events, as well as allowing the return of the~     patient to a State that allows high safely. The investigators thus performed this~     prospective study with the aim to assess the occurrence of adverse events during dental~     treatment and in the first 24 hours after sedation with midazolam, ketamine and sevoflurane~     in children aged four to six years. Our hypothesis was that no differences in adverse events~     among different association of drugs could be found.~   "
59071|NCT02284191|"~     This study aims to investigate the effect of early CTCA in patients with suspected or~     confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or~     Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a~     pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention.~     The primary objective will be to investigate the effect of the intervention on the~     proportion of patients with all-cause death or recurrent non-fatal type 1 or type 4b~     myocardial infarction (MI) at one year.~   "
59072|NCT02284178|"~     Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator)~     is often associated with complications, such as infection and lung injury. Leakage of~     secretions around the breathing tube (microaspiration) is a major factor leading to~     complications. The investigators propose that a standardized, enhanced oral suction protocol~     will be effective in reducing microaspiration and harms associated with mechanical~     ventilation. The investigators hypothesize that those randomized to the enhanced oral~     suction protocol will have less microaspiration and other ventilator-associated conditions~     than those in the usual care, standard suction group.~   "
59073|NCT02284165|"~     Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims~     and the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated~     with the use of rehabilitation services following hospitalization for ischemic stroke~   "
59074|NCT02284152|"~     In the present study, we tested a novel approach to understanding infant bottle-feeding~     interactions: experimentally manipulating bottle-feeding conditions to better understand~     maternal and infant influences on overfeeding, as well as individual differences in risk for~     overfeeding. Specifically, we observed mother-infant dyads during a typical, mother-led~     feeding, during which mothers were given no instruction regarding how or how much to feed~     their infants (hereafter referred to as a typical feeding [TF]), as well as during an~     infant-led (IL) feeding, wherein we minimized the mothers' influence on the feeding and~     ensured the feed was in response to the infants' hunger and fullness cues. Using this~     within-subject, objective, and experimental approach, the present study aimed to: 1)~     directly measure the extent to which overfeeding occurs during bottle-feeding and 2)~     describe the characteristics of infants and mothers that overfeed during bottle-feeding.~   "
59075|NCT02284139|"~     The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been~     demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and~     colorectal cancer (CRC). Dermatological reactions can cause significant physical and~     psycho-social discomfort to patients. In the present study, the investigators evaluated the~     effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects~     (ERSEs).~   "
59076|NCT02284126|"~     This study is a collaboration between NYP-Columbia and NYP-Cornell that seeks to evaluate~     the use of topical vancomycin and its reduction on surgical site infection (SSI) in~     neurosurgical procedures. Adult patients undergoing neurosurgery at either institution will~     be eligible for participation in this randomized control trial. Patients randomized to the~     treatment group will receive 2g of vancomycin applied as a powder or paste to the wound site~     and/or bone flap. Subjects in the control group will receive the current standard of care~     without topical vancomycin. All subjects will undergo swabbing of the anterior nares and the~     surgical site prior to surgery, once 10-14 days following the operation and 90 days~     following the operation. The primary outcome measure will be surgical site infection,~     assessed daily throughout the hospital stay, at the first follow-up visit, and by telephone~     at 30 days. Secondary outcomes will include length of hospital stay, length of intensive~     care stay, rate of reoperation and patient mortality. In addition, systemic vancomycin~     levels will be assessed at 6 hours and 24 hours postoperatively in each patient. Patients~     who have an external ventricular drain in place will have vancomycin levels assessed daily.~     In patients who have cranial drains placed, vancomycin concentrations will be analyzed from~     daily in wound drainage. Skin and nasal flora will be analyzed to assess the impact of~     topical vancomycin on the patient microbiome. Although there has been a decrease in the~     incidence of infections following craniotomy secondary to prophylactic intravenous~     antibiotics, proper sterile techniques, and other interventions, SSIs continue to~     significantly impact morbidity, mortality, and cost burden. Although never studied in~     neurosurgical procedures other than instrumented spine, the application of topical~     vancomycin to the surgical site prior to wound closure has demonstrated a reduction in SSIs~     in spine, cardiac and ophthalmologic procedures. The benefits of using prophylactic~     vancomycin topically, as opposed to intravenously, include reduced systemic levels of the~     drug, and therefore, a decreased probability of adverse events related to the drug, such as~     inducing resistance among native flora. The investigators propose a randomized control trial~     to evaluate the effectiveness of topical vancomycin in reducing SSIs rates following~     neurosurgical procedures.~   "
59077|NCT02284113|"~     This study will evaluate the iovera° device in treating pain associated with total knee~     arthroplasty (TKA). This study will also assess if overall pain medication is reduced~     following TKA and will investigate the relationship between patients treated with the~     iovera° device and length of hospital stay, pain, patient satisfaction and improved~     rehabilitation.~   "
59078|NCT02284100|"~     The relationship between human beings and animals, especially dogs, has existed for~     thousands of years. Historically, animals have held an important role in this relationship~     as they provide company, stimulus and motivation. Animals are excellent company, since their~     visitation they do not discriminate or segregate any person, that is, they are free of~     prejudice.~      In spite of the long-lasting presence of companion animals in human life, the idea that~     interaction with animals may exert a positive effect on human health is rather recent.~      The American Veterinary Medical Association classifies therapeutic animal assisted~     interventions (AAI) into three categories: animal assisted activities (AAA) that utilize~     companion animals; animal assisted therapy (AAT) that utilizes therapy animals and service~     animal programs (SAP) that utilize service animals. AAT in particular, is a goal-directed~     intervention in which an animal that meets specific criteria is an integral part of the~     treatment process. AAT is technically defined as the use of trained animals by trained~     health professionals to facilitate specific, measurable goals for individual patients for~     whom there is documentation of progress .~      Interest in AAT has been fueled by studies supporting the many health benefits. AAT has~     proven a useful adjunct in a variety of settings including mental health facilities, nursing~     homes and hospitals where most studies have been performed with adult patients with variable~     interventions, goals, patient characteristic and patient needs. In these studies, AAT~     resulted in significant reductions in anxiety, agitation and fear. In children, AAT dogs~     decreased distress during painful medical procedures, promoted calmness in children with~     post-traumatic stress disorders and increased attention and positive behaviors in children~     with pervasive developmental disorders.~      Surgical procedures and hospitalization can be stressful for both children and their parents~     and they are associated with pain, helplessness, fear and boredom. AAT has been shown to~     facilitate a child's ability to cope with hospitalization, but to date, no studies on AAT~     benefits in pediatric surgery have been reported.~      The purpose of this study was to better understand the effects of an AAT program on~     neurological, cardiovascular and endocrinological responses to stress and pain in the~     immediate post-operative period in children undergoing surgical procedures.~   "
59079|NCT02284087|"~     Introduction The motor impairment of the upper extremity is the most common sequelae after~     ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive~     technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor~     deficits remains moderate our days. To potentiate the effect of TMS, techniques called~     Paired Associative Stimulations (PAS) involving the integration of afferent sensory inputs~     at the level of the ipsilesional primary motor cortex were developed in healthy subjects.~     PAS techniques have shown a gain of corticospinal excitability by such phenomenon known as~     long Term Potentiation (LTP) and a gain of motor performance. The investigators would like~     to propose to evaluate two types of these techniques with a volley of visual afferents~     (visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two~     structures convey important information in the execution of the movement.~      Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V_PAS, CER_PAS,~     control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment,~     electrophysiological and MRI before, immediately post- and second post-assessments (4~     weeks).~      A group of 24 healthy subjects will undergo a parallel physiopathological study on the~     underlying mechanisms of cerebellar PAS~      Objectives Main objective: To determine whether (and how) Paired Associative Stimulation~     technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the~     control group.~      Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor~     performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type~     of PAS is capable of inducing changes in excitability of the corticospinal tract and~     duration Aim 4: Determine how PAS techniques modify the functional connectivity during~     movement Aim 5: Determine if connectivity changes during induced movement correlate with~     clinical improvements Aim 6: Determine whether patients who benefit of a type of PAS have~     specific anatomical lesion characteristics (volume, afferent and efferent white matter~     fasciculi integrity)~   "
59088|NCT02283970|"~     Prospective longitudinal study on four small groups of surgical patients affected by: BAV~     with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with~     isolated stenosis in over 60 year-old patients.~      The aim of the study is to select homogeneous small groups of surgical patients with the~     same subtype of BAV and same aortic behaviour and identify markers/predictors of~     favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more~     likely to be considered at high risk for aortic degeneration.~   "
59108|NCT02283710|"~     This randomized double blind clinical trial was performed in patients with non-alcoholic~     fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle~     modification plus Pentoxifylline groups. Liver function tests, metabolic profile and~     anthropometric measurements were checked at baseline and six months later.~   "
59080|NCT02284074|"~     The purpose of this study is to develop a nasal challenge model that causes a mild degree of~     inflammation, without causing any pain or symptoms, but that allows us to measure a variety~     of proteins in nasal secretions which causes inflammation in the nose. The nasal challenge~     model involves spraying the nostrils in the form of a fine mist with 4 different doses (1,~     10, 30 and 100µg per nostril) of lipopolysaccharide (LPS) including a placebo. LPS is a type~     of protein which has been carefully purified from the outer cell wall of certain bacteria,~     is sterile and does not contain live bacteria, and will not cause infection.~      The investigators will measure any inflammation in the nose by looking at cells collected by~     washing the inside of the nose (nasal lavage) and placing small strips of paper in the nasal~     cavity. The paper absorbs the nasal fluid and the chemicals produced during inflammation and~     can be extracted from the paper and analysed in the laboratory. The investigators will also~     be collecting a small amount of nasal epithelium taken by way of a nasal scrape; this is~     done by using a Rhinoprobe, a small plastic curette which is used to scrape a small piece of~     lining of the nose. The investigators hope that information obtained from this study will be~     used in future studies that will test new study drugs designed to treat diseases of the~     airways and lungs ( like asthma and chronic obstructive pulmonary disease (COPD) and hay~     fever.~   "
59081|NCT02284061|"~     Context: Sport and physical activity during and after cancer treatment can improve fitness~     and social inclusion in adults. In children, although early studies show interesting~     results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children~     following a physical training program showed a significant improvement in endurance, muscle~     tone, overall self-esteem, sports skills and self-perceived strength. The investigators then~     want to evaluate the health of a group of children during treat cancer that physical~     activities adapted compared to children who did not practice.~      Objective: Measuring the impact of physical activity program on health of children and~     adolescents with cancer with improved physical, psychological health, social reintegration~     and reduced time hospitalization.~      Method and Design: The study plans to include 90 children from the pediatric hematology -~     oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18~     months.~      This is a randomized controlled open trial open with a stratified distribution. Children~     will be randomized between two arms - Arm A (Experimental - Immediate Program): the child~     follows the physical activity program for a period of 18 months, as soon as his medical~     condition permits. - Arm B (Control - Delayed Program): the child does not participate to~     the program during the first 6 months, and he joins the delayed program late after 6 months.~     Each child integrates the physical program for a period of one year.~      Regardless of the randomization arm, the child performs the initial tests, the intermediate~     tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be~     performed at 3 and 9 months.~      The physical activity program includes a minimum of 30 days of activities per 6 months~     (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.~      The investigators aim at demonstrating a difference of 50 meters on the total walked~     distance during the endurance test in the experimental group as compared to the control~     group after 6 months of program.~   "
59082|NCT02284048|"~     This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow~     reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with~     MVA~   "
59083|NCT02284035|"~     A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety,~     tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when~     replacing standard combination therapy in HIV-infected patients with prolonged virological~     suppression~   "
59084|NCT02284022|"~     the objective of this protocol is evaluate the safety and tolerance of a communication~     system for severely disable patients with myopathies. The system analyses the brain electric~     activity in real time and converts it into digital commands for a spelling device, which is~     refered to as the P300 speller in the scientific literature. The secondary objective is to~     compare the performance of such tool with a more traditional assistive technology for the~     communication of severely disabled patients : scanner systems.~   "
59085|NCT02284009|"~     This is a Phase II, randomized, double-blind, parallel group, placebo controlled,~     multicentre study of 52 weeks treatment duration. The primary objective is to evaluate the~     efficacy(on endogenous insulin secretion), safety and tolerability of weekly albiglutide (a~     glucagon-like peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin~     therapy in subjects with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin~     production.. Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that~     51 subjects receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once~     weekly at Week 6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17~     subjects receive placebo once weekly added-on to insulin therapy. The total duration of a~     subject's participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks~     of treatment and 12 weeks of Post-treatment Follow-up)~   "
59086|NCT02283996|"~     The purpose of this study is to identify individuals 18 or older who have diagnostic~     presentation of adhesive capsulitis and randomize them into two arms, distinguished by use~     of physical therapy and steroid injections compared with steroid injections followed by~     watchful waiting. This prospective study will be used to determine whether there is a~     significant impact on patient outcome and whether the additional financial burden is~     justified. There are no experimental interventions for this study. The use of physical~     therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the~     standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a~     significant difference in outcome between the two study arms. One group will undergo regular~     physical therapy with corticosteroid injections (Arm 1) and the other will have steroid~     injections during the inflammatory phase only and then be regularly observed (Arm 2). We~     also hypothesize there will be a significant financial burden associated with the PT arm~     that is not justified with the possibility of increased symptom reports in that arm.~   "
59087|NCT02283983|"~     For the specific patient population studied receiving 5-Fluorouracil, epirubicin and~     cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection~     has never been assessed.~      The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well~     established in this population (breast cancer in the adjuvant setting) and is based solely~     on a publication (Scotté) that does not contain the same therapeutic modalities (dose~     significantly higher). The few studies available have heterogeneous populations,~     nonrandomized, retrospective or with a small sample.~      By extension to what has been observed with higher cumulative doses of docetaxel, some teams~     offer mittens and booties chilled to their patients, a practice that is not the subject of a~     national consensus.~      The investigators wish to accurately assess the effectiveness of mittens and slippers~     chilled, their tolerance and their observance because of weak data on this specific~     population in the literature.~   "
62813|NCT02235077|"~     The primary objective of this study is to test the hypothesis that high-dose spironolactone~     will lead to greater proportional reduction in NT-proBNP levels from randomization to 96~     hours over standard of care.~   "
59089|NCT02283957|"~     Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection~     study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo~     injected into the intermetatarsal space around a Morton's neuroma. The injection of study~     medication will be administered by ultrasound-guided needle placement following ankle block~     anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects~     will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.~   "
59090|NCT02283944|"~     The proposed project aims to develop novel electrochemotherapeutic treatment of glioblastoma~     multiforme (GBM). Standard treatment has limited effect on survival and quality of life.~     Electrochemotherapy is a novel and promising treatment, which has demonstrated convincing~     results in the treatment of various types of carcinoma. The treatment is based on a~     combination of electrical current stimulation of tumor cells and simultaneous administration~     of chemotherapeutic drugs. Electrochemotherapy works by inducing an electrical current~     between implanted electrodes in the tumor tissue, causing electroporation of the cancer cell~     membranes, and thereby increasing the cellular permeability and drug uptake.~     Electrochemotherapy has proven to be an efficient way of considerably increasing the potency~     of the chemotherapeutic drug bleomycin in malignant cells in skin tumors and carcinoma~     metastases, and thereby increasing cytotoxicity of the drug locally in the tumor tissue.~     This allows for treatment with lower doses of chemotherapeutic drugs and more defined, local~     area of effect, thus decreasing systemic effects. The investigators propose to use a novel~     non-invasive and safe technique called focused transcranial magnetic stimulation (focused~     TMS) to induce electrical current in the tumor tissue. TMS is a safe and widely implemented~     technology used to treat multiple neurological diseases such as pain, depression and stroke.~     Studies have shown that effective electroporation of cell membranes can be obtained using~     induction of electromagnetic fields in a cell suspension, and new focused TMS further~     enables focused treatment of selected brain regions without surgical intervention and,~     thereby focusing chemotherapeutic treatment to pathological tissue and avoiding surgery~     related brain tissue damage. Additionally, TMS transiently increases blood-brain barrier~     permeability, theoretically allowing increased uptake of chemotherapeutic drugs in the~     target area. This addresses a significant challenge in the treatment of brain cancer, as~     most cytotoxic drugs have fairly limited ability to pass the blood brain barrier.~      The intention of this research project is to investigate the therapeutic potential of~     focused TMS as an alternative non-invasive source of current induction and thereby means to~     treat several types of brain cancer with electrochemotherapy.~   "
59091|NCT02283931|"~     There is currently little information regarding the hemodynamic differences in uterine~     displacement techniques. Previous studies examining the hemodynamic effects of uterine~     displacement maneuvers have focused on incidence of hypotension and use of ephedrine.~      Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are~     becoming popular techniques in anesthesiology because they can provide noninvasive, valid,~     and precise hemodynamic data.There has been no study specifically examining the hemodynamic~     differences between the uterine displacement techniques using NICOM or TTE. While all three~     uterine displacement techniques are recommended, whether one technique may maximize maternal~     cardiac output is currently unknown.~   "
59092|NCT02283918|"~     The primary objective of the study is to develop MS patient-matched healthy population norms~     for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of~     the United States (US), France, and Italy.~   "
59093|NCT02283905|"~     All patients with pulmonary blastomycosis requiring mechanical ventilation will have their~     blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as~     well as an analysis of the susceptibility of their infecting species of blastomyces. This~     information will then be analyzed relative to their rate of clinical recovery from this~     serious fungal infection.~   "
59094|NCT02283892|"~     This is a randomized clinical trial that evaluates the impact of using an internet-based~     checklist for systematic assessment of patients reporting respiratory complaints with the~     conventional assessment, without using the checklist.~   "
59095|NCT02283879|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.~   "
59096|NCT02283866|"~     Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern~     anesthesia. The purpose of this study is to compare two methods of administering desflurane,~     an volatile anesthetic during balanced anesthesia. The investigators hypothesized that~     administering desflurane at 1 MAC (minimum alveolar concentration) during balanced~     anesthesia will be more beneficial in terms of stability of the patient's vital signs and~     hypnotic depth than administering desflurane according to the patient's BIS (bispectral~     index) value.~   "
59097|NCT02283853|"~     Part 1 main objectives of study 109MS306 (NCT02283853) are as follows: To evaluate the~     safety, tolerability, and effect on the disease course of BG00012 (dimethyl fumarate) in~     pediatric participants with RRMS, as compared with a disease-modifying treatment; To assess~     pharmacokinetic (PK) and pharmacodynamic (PD) parameters in a representative subset of~     pediatric participants; and To assess health outcomes and evolution of disability. Part 2~     primary objective is to evaluate the long-term safety of BG00012 in pediatric participants~     who completed Part 1 of Study 109MS306 (NCT02283853).~   "
59098|NCT02283840|"~     Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover~     design~   "
59099|NCT02283827|"~     Single centre, open-label, multiple doses, two parallel study groups each receiving two~     formulations in a one-sequence design~   "
59100|NCT02283814|"~     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups~     of healthy volunteers~   "
59101|NCT02283801|"~     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups~     of healthy volunteers~   "
59102|NCT02283788|"~     A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period~     crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization~     in healthy adult men and women~   "
59103|NCT02283775|"~     Primary Objective:~      Safety~      Secondary Objective:~      Efficacy, Pharmacokinetics (PK)~   "
59104|NCT02283762|"~     To investigate if Riociguat is effective in the treatment of systemic sclerosis~   "
59105|NCT02283749|"~     In this study patient's will receive the medicine Xofigo which is a radioactive drug that is~     FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not~     previously been tested to treat lung cancer that has spread to the bones. Your doctors are~     studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread~     to the bones.~   "
59106|NCT02283736|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root~     planning (SRP).~      Material and methods: Thirty six chronic periodontitis patients will be recruited and~     monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months~     after therapy. All patients will receive scaling and root planning and randomly will be~     assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18)~     group. The tablets will be used once per day during 3 months.~   "
59109|NCT02283697|"~     High salt diet increases risk of development of hypertension. In hypertensive patients, low~     salt diet decreases blood pressure. Not surprisingly public health authorities endorse low~     salt diet in hypertensive patients. But, surprisingly, average salt intake among adults in~     Canada remains stubbornly high. Low effectiveness of fast counselling by physicians and~     nurses on dietary salt is partly the culprit. Methods used in successful clinical trials~     (eg. provision of meals, community cooking sessions, many hours of counselling by~     dieticians) cannot be used in routine clinical practice. Hence the investigators propose a~     study on a pragmatic dietary counselling method suitable for clinical practice.~      Hypertensive patients will be randomized to receive standard care (which includes~     counselling by the usual healthcare team, including doctors and nurses) or to receive~     additional counselling from a registered dietician. This counselling will include two~     components: a one hour counselling session, and 4, once-weekly telephone calls.~      Effectiveness of this counselling will be measured by checking sodium in the urine from a 24~     hour collection (which is a measure of dietary salt intake) at baseline and at 4 weeks. In~     addition, the investigators will also measure urinary sodium at 1 year, to assess if this~     effect of counselling persists over a longer time.~   "
59110|NCT02283684|"~     With a growing body of knowledge on the promising advancements and recent clinical data of~     the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the~     world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium~     laser technology.~      In this study the investigators planned to test the Greenlight (532-nm) laser PVP using~     (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary~     to small to moderate sized BPH in a prospective randomized trial.~   "
59111|NCT02283671|"~     First in human study to assess the tolerability and safety profile of treatment with~     dendritic cell in patients with multiple sclerosis or neuromyelitis optica.~   "
59112|NCT02283658|"~     This pilot, phase II trial studies how well everolimus and letrozole work in treating~     patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal~     cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor~     cells by blocking some the enzymes needed for cell growth.~   "
59113|NCT02283645|"~     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for~     chest hair enhancement.~   "
59114|NCT02283632|"~     This is a single site trial to assess metabolic effects in subjects after a Jejunal~     Diversion procedure was performed.~   "
59115|NCT02283619|"~     Purpose of the study:~      The goal of this study is to evaluate the relationship of electrocardiogram (ECG) findings~     with clinical outcomes in a cohort of patients with left bundle branch block (LBBB) who are~     being evaluated for acute coronary syndrome (ACS) in the Emergency Department (ED).~      Background and significance:~      The significance of specific ECG findings in patients with LBBB being evaluated for ACS has~     been inadequately studied, and this gap in knowledge is a barrier to optimal management of~     this population. Due to the speed, availability, low cost, and non-invasive nature of the~     ECG, it would be ideal to identify ECG characteristics that help to risk stratify these~     patients in order to inform clinical decision-making, reduce unnecessary invasive testing,~     and conserve resources.~      Methods:~      In this prospective observational study the investigators will identify a consecutive series~     of adult patients with LBBB presenting to the ED with suspicion of ACS. The investigators~     will collect data including demographics, cardiac risk factors, initial ECG measurements,~     lab and radiographic results, procedure results, and clinical outcomes such as 30-day death~     or myocardial infarction (MI). The investigators will analyze the data using a cohort study~     design to calculate odds ratios between ECG characteristics and the outcomes of interest.~   "
59116|NCT02283606|"~     The investigators aim to measure sonoelastographically the elasticity of the uterine cervix~     in pregnant patients at term before induction of labor and compare between patients with~     successful and failed inductions.~   "
59117|NCT02283593|"~     The purpose of this study is to observe and evaluate the use of a relapse prevention program~     over time among internet help-seekers. Participants are recruited via a nationally known~     portal for assisting anonymous individuals with changing their problematic alcohol use in a~     healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and~     includes 7 relapse prevention modules, with a three-week pause between the 6th and 7th~     modules. Baseline data are collected regarding substance use and psychosocial health and~     follow-up takes place 10 weeks after recruitment. The study is observational.~   "
59118|NCT02283580|"~     Recent work have shown that low load, high-repetitive single limb resistance training, if~     compared to a control, can increase limb muscle function and functional exercise capacity in~     patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of~     limiting exertional symptoms. However, no comparison to another exercise regimen have been~     performed. In addition neither the intramuscular nor the mechanism of this exercise regimen~     have been investigated and represents the aim of the proposed project. We will in a~     prospective, assessor-blind; block randomized controlled, parallel-group trial compare~     single-limb to two-limb low load, high-repetitive resistance training in patients with~     severe and very severe COPD~      The research hypothesizes are:~        -  that single-limb low-load high-repetitive resistance training will provide larger gain~          in the 6-min walking distance than two-limb low-load high- repetitive resistance~          training in patients with severe to very severe (stage III-IV) COPD.~        -  that eight weeks of single limb training should also be associated with larger~          physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and~          structural (muscle protein synthesis, fiber-type distribution and capillarization)~          muscle adaptations to training, lower cardio- respiratory demand, as well a greater~          increase in health-related quality of life in comparison to two-limbs simultaneous~          training.~      We will also compare the groups at baseline to investigate the acute effects and mechanisms~     of single-limb to two-limb low load, high-repetitive resistance training, a comparison that~     also will include healthy matched controls.~      The research hypothesizes are:~        -  that involving a large muscle mass during exercise (e.g., two-limb low load,~          high-repetition resistance training) compared to involving a small muscle mass during~          training (e.g., single limb low load, high-repetition resistance training) would lead~          to larger restraints on the cardiorespiratory system in patients with severe to very~          severe COPD. Conversely, single limb interventions should produce less dyspnea and more~          muscle deoxygenation and fatigue than two-limb simultaneous exercise while healthy~          controls will be able to perform both legs/arms exercise without a central constraint,~          and no negative consequences on muscle fatigue or exercise stimulus.~   "
59119|NCT02283567|"~     The investigators aim to compare elasticity of the uterine cervix in singleton and twin~     pregnancies of similar gestational age.~   "
59148|NCT02283008|"~     The evidence for poor inhaler technique is both well established and observed worldwide.~     What is unclear from the evidence is why individuals demonstrate poor technique, despite the~     majority admitting to having previously had instruction on inhaler technique. The primary~     research question is 'Will there be a difference between post education inhaler technique~     scores when comparing structured education against informal education?'~      To try and establish why individuals use inhalers incorrectly a semi structured interview is~     proposed~   "
59120|NCT02283554|"~     ABSTRACT:~      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which~     releases various growth factors that promote tissue regeneration. Metformin (MF), a member~     of biguanide group has been shown to facilitate osteoblast differentiation and thus may~     exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the~     combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of~     intrabony defects in chronic periodontitis (CP) subjects.~      Methods: One hundred and twenty subjects with single defects were categorized into four~     treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical~     parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI),~     probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were~     recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic~     intra-bony defect depth reduction was evaluated using computer-aided software at baseline~     and 9 months.~   "
59121|NCT02283541|"~     Falls are the leading cause of injury--‐related hospitalization and death in the elderly. As~     such, fear of falling (FOF) is common among senior populations and often leads to activity~     avoidance, social isolation, and reduced physical and mental health. Risk of falls is~     particularly concerning for individuals suffering from late life depression (LLD) as both~     depression and antidepressant treatment have been shown to be linked to gait impairments, a~     strong predictor of fall risk. Currently, our team is conducting a study to examine the~     effects of a non--‐pharmacological mind--‐body therapy commonly known as automatic~     self--‐transcending meditation (ASTM) on autonomic and mood--‐related symptoms of LLD. This~     study provides a timely opportunity to explore the intricate relationship between gait~     disturbances and depression severity, as well as the potential benefits of ASTM intervention~     on gait and FOF in seniors. Using a GAITRite® portable walkway, measures of stride length~     and gait velocity will be obtained for seniors in the ASTM and control study arms every four~     weeks for the duration of the ASTM program. The aim of this study is to answer the following~     research questions: are gait impairments and depression severity correlated, and does ASTM~     training have any effect on gait and FOF? The results of this study could not only provide~     insight into the physical manifestations of depression but if ASTM training is found to~     improve gait and reduce FOF then there is potential to use this mind--‐body meditation~     technique as an adjunct therapy to reduce fall risk in seniors with LLD. Furthermore, future~     research could expand upon these findings to examine the benefits of ASTM on gait~     impairments secondary to other psychiatric illnesses.~   "
59122|NCT02283528|"~     Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth~     together or using small titanium plates and screws to fix the fracture. With either~     technique the upper and lower teeth are held together to ensure that the fracture is held in~     the correct position during healing (for closed reduction) or while the plate and screws are~     applied (for open reduction).~      The teeth can be held together using Erich arch bars which are a type of braces that are~     temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture~     has healed even though the patient is able to open his mouth immediately after the surgery~     is complete. The alternative to the traditional Erich arch bars is a relatively new type of~     arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth.~     The purpose of this study is to compare the two types of arch bars in terms of the speed~     with which they can be applied as well as any difference in fracture healing~   "
59123|NCT02283515|"~     BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth~     supporting tissues and alveolar bone that surround the tooth leading to formation of deepend~     gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and~     tooth loss. In the literature, several pharmacologic agents have been administration via~     local delivery route, directly into diseased sites affirming greater improvement in~     periodontal status. Therefore, present study was conducted to determine the clinical~     effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an~     methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to~     scaling and root planing for treatment of chronic periodontitis patients.~      MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group~     I -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included~     modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level~     (CAL), were recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic~     assessment of intrabony defect (IBD) fill was analysed at baseline and after 6months using~     computer-aided software.~   "
59124|NCT02283502|"~     The objectives of this program are to verify the safety and effectiveness of the MRgHIFU~     system developed by the division of Medical Engineering of National Health Research~     Institutes (NHRI)~   "
59125|NCT02283489|"~     This study will investigate the efficacy and safety of recombinant human endostatin~     adenovirus combined with chemotherapy for advanced head and neck malignant tumors.~   "
59126|NCT02283476|"~     Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and~     safety have been defined. However, the compliance is unsatisfactory since routine i.v of~     Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous~     intravenous infusion by using venous pump can improve the compliance.The comparative study~     in efficacy and safety has not been done concerning continuous and routine i.v.In addition,~     what patient can be benefited from Endostar have not been investigated. The biological~     markers, such as circulating endothelial cells，CECs, will be explored in the study.~   "
59127|NCT02283463|"~     This study will test a suction-based method of engaging the cervix. Bioceptive has developed~     a device that more gently and atraumatically attaches to the cervix with no bleeding. This~     novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been~     performed on the device including testing on synthetic uterine models, human cadavers, and~     human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts~     have shown effective attachment to the cervix and the ability for the device to maintain~     suction throughout a procedure atraumatically. This study proposes to introduce this minimal~     risk device in a clinical setting to determine the response of women undergoing gynecologic~     procedures.~   "
59317|NCT02280759|"~     Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is~     increasingly being marketed as an antidiarrheal drug. A randomized, double blind,~     placebo-control trial was performed to assess the effectiveness of GT in management of~     children with acute gastroenteritis.~   "
59128|NCT02283450|"~     Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated~     cardiomyopathy patients with heart failure.~      Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy (~     cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University~     from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal~     diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the~     experimental interferences were avoided and patients were divided into the experimental~     group and the placebo group. The patients in experimental group received the relevant tests~     and inspections before the beginning of experiment，signed the informed consent. Then the~     investigators get the venous blood centrifugalization and cryopreservation. The patients~     take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the~     investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and~     keep blood specimens. Three and six month later，electrocardiogram and echocardiography were~     taken and the determination of the NT - proBNP was done. The placebo group was followed up~     in the same way.~   "
59129|NCT02283437|"~     This proposed randomized controlled trial will test the effectiveness of a problem-solving~     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum~     disorders. A repeated-measures, three-group design will be used to evaluate and compare the~     effects between two treatment groups(PSBBP and psycho-education group) and routine~     outpatient service and family support(control group) for 129 randomly selected family~     caregivers of outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.~   "
59130|NCT02283424|"~     This is a randomized ,opened, prospective controlled trial of clinical effectiveness for~     Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma~     patients with epidermal growth factor receptor gene mutation~   "
59131|NCT02283411|"~     The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor~     Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose~     Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing~     over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring~     System - Professional Sensors will be worn by adult subjects over a 14-day wear period.~      The primary objective is to characterize the Systems performance with respect to YSI~     reference venous sample measurements. The device performance will be primarily evaluated in~     terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in~     reference to YSI.~      Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by~     Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.~      240 subjects will be enrolled and additional healthy subjects may also be enrolled in the~     study as training subjects.~   "
59132|NCT02283398|"~     We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the~     TAVI setting to reduce post-procedural myocardial damage and improve patient outcome.~     Accordingly, we aim to investigate whether RIPC can be introduced as an integral part of the~     TAVI procedure, in order to reduce post-procedural myocardial damage and potentially improve~     patient outcome.~   "
59133|NCT02283385|"~     There is no current elder abuse service that systematically assesses and provides services~     to address the mental health needs of older adult abuse victims. The proposed study will~     investigate the efficacy of a skill-based, mental health intervention to help treat elder~     abuse victims, bolster mental health outcomes, and improve detection of symptomatology in~     future screenings.~   "
59134|NCT02283372|"~     A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT~     for locally advanced and borderline resectable pancreatic cancer. The goal of this study is~     to evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely~     delivered and enhance efficacy of tumor directed radiation therapy.~   "
59135|NCT02283359|"~     The main purpose of this study is to see whether the combination of selinexor (KPT-330) and~     irinotecan can help people with esophageal or stomach cancer. Researchers also want to find~     out if the combination of selinexor (KPT-330) and irinotecan is safe and tolerable.~   "
59136|NCT02283346|"~     The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery~     using higher daily fractions than those used routinely. In this way can cause more damage~     tumor, especially in tissues that have a slower proliferation rate, as in the case of~     prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a~     lesser chance of development of collateral in tissues of high multiplication rate as the~     lining of the rectum and bladder effects.~      With brachytherapy boost for high dose rate is achieved by administering a more intense dose~     on the tumor and lower the sound around the region to be treated tissues, improving the~     therapeutic window.~      Treatment with retracted and fully ambulatory time, has potential benefit as early patient~     return to usual activities and optimizing the flow of patients who require treatment with~     radiotherapy. This prospective study aims to assess the results and the toxicity profile of~     this treatment regimen retracted.~   "
59147|NCT02283021|"~     Calcium is an extremely important ion used in our body for many processes. One of its tasks~     is to control gene expression. Cells intake calcium from their surroundings though special~     calcium channels located on the surface membranes of the cells.~      The great many studies on such calcium channels were performed on excitable cells such as~     muscle, heart or neuronal cells, where the calcium ions are controlled by voltage.~     Surprisingly, not much is known about the identity of calcium subunits in non-excitable~     cells like epithelial cells (which compose most of the connective tissue in the body), liver~     cells, lung cells, immune system cells, etc.~      Recently, the investigators have shown that calcium channels from muscles are, in fact,~     expressed in T cells of the immune system, where they are used for proliferation. The~     investigators postulated that probably other cell types, especially cancerous cell types,~     might be using these subunits similarly.~      The aim of this study is to determine the identity and sequence of calcium subunits~     expressed in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide~     lung cancer deaths.~   "
59256|NCT02281552|"~     This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib~     modified release tablet taken once a day in patients with rheumatoid arthritis who continue~     taking methotrexate. Results for the modified release tablets will be compared to the~     efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in~     patients with rheumatoid arthritis who continue taking methotrexate.~   "
59137|NCT02283333|"~     The purpose of this study is to compare the efficacy of an experimental treatment (termed~     BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved~     standard of care treatment. Currently, treatments for grief in Veterans remain understudied.~     Our research group has recently completed pilot work on an innovative, technology-leveraged~     treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure~     (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA /~     DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive~     Restructuring and Supportive Grief Counseling.~      The study will enroll 140 Veterans, aged 21 years and older, who served in any combat era.~     All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3~     months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7~     weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via~     televideo to the Veteran's home.~      We hypothesize that BATE-G will be more effective than standard treatment in reducing~     symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more~     effective in reducing acute emotional distress and preventing long-term emotional distress~     in terms of general depression and anxiety symptoms. BATE-G will result in increased~     frequency of completed positively reinforcing, community-based events when compared to~     Cognitive Restructuring and Supportive Grief Counseling. BATE-G will also result in greater~     improvements in perceived social support and health.~      Note: This project is the first evidence-based treatment for PGD in military populations,~     thus addressing a significant service gap.~   "
59138|NCT02283320|"~     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients~     with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or~     squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one~     prior platinum-containing chemotherapy regimen.~   "
59139|NCT02283307|"~     The goal of this study is to validate that Dual Energy CT (DECT) urography when performed~     with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better~     image quality and equal or better diagnostic capability compared to traditional Single~     Energy CT (SECT) performed with a standard contrast dose.~   "
59140|NCT02283112|"~     This study aims to ensure that assays that measure drug concentrations are accurate and~     precise in different matrices when quantified using high performance liquid chromatography~     -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various~     bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile~     dysfunction agents. Samples will also be obtained from individuals not receiving these~     medications for quality control purposes.~   "
59141|NCT02283099|"~     The study is designed to establish safety, tolerability and immunogenicity of~     rVSVΔG-ZEBOV-GP (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular~     stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire),~     investigated at three different dose levels in 30 healthy adults in Germany. This study is~     part of the WHO led VEBCON consortium that is aiming to generate harmonized data for the~     rVSVΔG-ZEBOV-GP (BPSC1001) vaccine candidate to allow optimized rapid decisions on dose and~     safety.~   "
59142|NCT02283086|"~     DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted~     from January 1, 2012-December 31, 2013.~      SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.~      PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and~     randomized to receive feedback reporting or not.~      INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized~     group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients),~     and yield (percentage of CTPEs positive for PE) beginning January 2013.~   "
59143|NCT02283073|"~     The main objective of the study is to design and validate the blood based PDx gene~     expression assay for the early diagnosis of Parkinson's disease patients. Differential~     diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy,~     Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.~   "
59144|NCT02283060|"~     Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral~     medications given for the treatment of HIV. Both drugs are reasonably well tolerated.~     However, efavirenz, a component of Atripla, is known to cause mental side effects.~      This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be~     associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon~     withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep~     and cognition may represent the best option to determine whether use of efavirenz is~     associated with effects on sleep and cognition beyond the immediate period following~     initiation of drug.~   "
59145|NCT02283047|"~     Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover,~     the concept that obesity and HTN can be additive in terms of cardiovascular rist is widely~     accepted. Yet, clinical decision-making in obese patients is complicated by a surprising~     lack of evidence on the relative importance of obesity and HTN treatment and its efficacy~     and safety. Lifestyle interventions are the mainstay of obesity management programs and are~     also advocated in the prevention and treatment of HTN. Physical exercise and diet are~     recommended to prevent and control obesity and HTN. Aerobic exercise is firmly established~     as an effective measure for lowering blood pressure and reducing cardiovascular risk.~     However, there is no agreement about the optimal dose of frequency, intensity, duration and~     type of exercise. Therefore, the aims of the study are: 1) to assess the changes in selected~     parameters of blood pressure, cardiorespiratory fitness, body composition and biological~     markers brought about by a period of 16-week of different aerobic exercise programs with~     hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to~     examine the effect of six months detraining subsequent to intervention. Secondary objectives~     are to examine the additional effect of the intervention on physical activity behavior and~     health-related quality of life.~   "
59146|NCT02283034|"~     The aim of this study was to compare five CPR feedback devices to standard BLS in terms of~     the quality of single rescuer pediatric resuscitation. Therefore, the investigators~     hypothesis was that there would be no difference between CPR methods in terms of chest~     compression quality parameters.~   "
59257|NCT02281539|"~     The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful~     condition affecting 70% of amputees, so as to improve these patients' quality of life.~   "
59149|NCT02282995|"~     Background:~      Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology~     of functional dyspepsia is uncertain. Risk factors include genetics, gender, age,~     helicobacter pylori infection, etc. However, few reported the association of genetic~     contribution to the development of FD and mood disorder.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims:~        -  To evaluate genetic factors on development of functional dyspepsia & common mood~          disorders~        -  To evaluate genetic factors on the severity of function dyspepsia & mood disorders~        -  To develop a diagnostic test for classification of functional dyspepsia by plasma~          ghrelin and serotonin expression~        -  To collect sleep data for future use~        -  To save blood sample for future retrospective diagnostic or genetic examination~      Study design:~      Case-control cross sectional study~      Number of subjects:~      Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300~     Controls + 300 FDR)~      Patient population:~      Functional dyspepsia patients age 18-60~      Duration of study:~      1 May 2012 - 30 April 2013~      Primary variable(s):~      Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression~      Secondary variable(s):~      FD global symptom assessment and symptom scores~      Number of visits: 1~      Hypotheses:~        -  Shared genetic factors contribute to the development of FD and common psychological~          disorders~        -  FD patients contribute to suppression of plasma ghrelin and serotonin expression~          compared to healthy controls~   "
59150|NCT02282982|"~     This was a non-interventional, prospective, multi-center study with no control group~     designed to assess the effectiveness of palivizumab in a population of infants at high-risk~     of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation~     and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease~     (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October~     2014 through April 2015, in routine clinical settings throughout the Russian Federation.~   "
59151|NCT02282969|"~     Objectives:~      This protocol addresses the first phase of a larger project funded by the Patient-Centered~     Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer~     screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted~     for the larger, comparative study. In this initial development phase, our prototype patient~     decision aid will be updated to reflect current guidelines about lung cancer screening. The~     updated aid will then be pilot-tested in a new sample of patients. In addition, several of~     the study measures will be refined and further developed in preparation for the larger~     study.~      The specific aims of the measures and decision aid development phase of this project are as~     follows:~      Update the aid to reflect current screening guidelines and refine the aid via cognitive~     testing with patients/smokers; and pilot test the updated aid for acceptability with~     patients/smokers.~      Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new~     measure with patients/smokers, and evaluate the reliability of the new measure in a sample~     patients/smokers.~   "
59152|NCT02282956|"~     Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with~     NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some~     institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But~     this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all~     surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could~     be superior compared to standard pain treatment. A great variability of nerve supply of the~     foot is well described. There are some hints that the posterior tibial nerve supplies the~     first metatarsal bone and the first metatarsal joint. A nerve block could reduce~     postoperative pain in hallux surgery. To assess the effectiveness of this investigated~     measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness~     of the tibial nerve block.~   "
59153|NCT02282943|"~     The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS~     stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain~     scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at~     1, 3 and 5 years as well as psychological state and quality of life.~   "
59154|NCT02282930|"~     This study is designed to answer whether patients with progressive IgA nephropathy, who~     receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6~     months is effective in inducing improvement in proteinuria and renal function.~   "
59155|NCT02282917|"~     This will be a multi-center, proof of concept phase 0 study to assess the suppression of~     p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing~     tumor resection. AR-42 is a small molecule which crosses the blood brain barrier (BBB) in~     rodents, but the investigators are not certain yet if it will penetrate human VS.~     Meningiomas are outside the BBB, but seem to be unusually resistant to all current medical~     treatments. The primary endpoint of the bioactivity of suppression of p-AKT by AR-42 was~     selected as drug activity seems more informative than bioavailability. Our preclinical data~     and others have shown dose dependent suppression of p-AKT by AR-42 in both VS and~     meningiomas.~   "
59156|NCT02282904|"~     Background:~      - Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a~     bone marrow transplant from a fully matched donor. Researchers want to try using partially~     matched donors for patients who do not have a fully matched donor available. The researchers~     will also use the drug cyclophosphamide to try to improve the outcomes when using a~     partially matched donor.~      Objective:~      - To learn the effectiveness of using cyclophosphamide with a transplant from a partially~     matched donor in treating CGD.~      Eligibility:~      - Recipients: age 2-65 with CGD with an ongoing infection that has not been cured by~     standard treatment and no fully matched donor available in an appropriate timeframe.~      Design:~        -  Recipients will:~             -  be admitted to the hospital 2 weeks before transplant.~             -  be screened with blood and urine tests, breathing and heart health tests, X-rays,~               and/or magnetic resonance imaging. They may have a bone marrow aspiration and~               biopsy.~        -  meet with a social worker and dentist.~        -  get chemotherapy, radiation, and other medicines.~        -  get an intravenous (IV) catheter in their chest.~        -  have the transplant.~        -  get more medicines and standard supportive care.~        -  have blood drawn frequently.~        -  have to stay in the Washington, D.C. area for 3 months post-transplant.~        -  be followed closely for the first 6 months, and then less frequently for at least 5~          years.~   "
59157|NCT02282891|"~     The purpose of this study is to compare the hemodynamic effects of a standardized induction~     of general anesthesia with either propofol or ketofol in patients with physical status~     classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT)~     with two arms of treatment groups. One arm will consist of induction of general anesthesia~     using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose~     will be 1.5mg/kg of propofol and 0.75mg/kg of ketamine; the second arm will consist of~     induction of general anesthesia using propofol 2mg/kg. The primary outcome of the~     intervention will consist of hemodynamic changes during the first 30 minutes after induction~     of general anesthesia.~   "
59158|NCT02282878|"~     The purpose of this work is to investigate the influence of dietary salt intake on immune~     function in multiple sclerosis (MS) subjects and healthy controls. This study primarily~     tests the hypothesis that higher dietary salt intake will be associated with a higher~     frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells.~     If a relationship between dietary salt intake and immune function is observed, this study~     will also test: a) whether this relationship is unique to MS subjects or whether it is also~     present in healthy controls, and b) whether healthier immune function can be restored by~     restricting dietary salt intake.~   "
59159|NCT02282865|"~     Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system.~     Anxiousness, which tend to result from the deficient action of parasympathetic nervous~     system, likely to show low HRV. This study is to investigate the relationship between the~     surgery-related anxiety and the HRV which is known to reflect the balance of autonomic~     nervous system. Furthermore, this study also focuses on HRV's role as a predictor for~     aggressive emergence behavior, which might also be considered as partially related to~     imbalance of autonomic nervous system.~   "
59160|NCT02282852|"~     Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected~     diseases of the small bowel. The procedure is safe and noninvasive, the main risk being~     capsule retention occurring in approximately 2% of procedures. Other problems such as~     incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric~     emptying, slow small bowel transit, faulty equipment and poor bowel preparation.~      Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime'~     viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an~     intramuscular prokinetic injection if this fails. This approach has disadvantages since an~     intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly~     used for this purpose, has a risk of acute dystonic reactions particularly in young~     patients.~      Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the~     capsule in the upper GI tract. We propose that this could be used, alongside positional~     changes, to expedite capsule transit through the stomach thus improving completion rates and~     avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled~     study comparing a standard protocol for small bowel capsule endoscopy against a hand held~     magnet and positional change protocol to enhance gastric emptying of the wireless capsule.~   "
59161|NCT02282839|"~     This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy~     with/without chemotherapy due to head and neck cancers. Basic data will be recorded along~     with tumor related variables. Then they will be divided randomly into study group and~     control group. The study group will receive oral glutamine during radiotherapy while the~     control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO~     grading system), pain status (visual analogue scale), quality of life questionnaires will~     also be documented. The differences between the two groups will be analyzed.~   "
59162|NCT02282826|"~     Primary Objective:~      To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV)~     and subcutaneous (SC) doses in men and women with progressive multiple sclerosis.~      Secondary Objectives:~      To assess the following in men and women with progressive multiple sclerosis:~        -  The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.~        -  The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.~        -  The PK parameters of GZ402668 after ascending single SC doses.~        -  The PD of GZ402668 after ascending single SC doses.~   "
59163|NCT02282813|"~     This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or~     CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules~     in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D~     insufficiency in stage 3 or 4 chronic kidney disease patients.~   "
59164|NCT02282800|"~     The study was to intended to visualize the nuclear localization of vitamin D receptor in~     oral tissues of aggressive periodontitis patients to better understand the potential for~     receptor in disease activity or progression.~   "
59165|NCT02282787|"~     During LA in retinal surgery there is some problem as regard the lack of anaesthesia~     duration and unexpected globe movement .so many adjuvant was added to LA to overcome this~     disadvantages of LA such as clonidine and fentanyl .~      The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong~     anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation~     of LA.There are Many studies had described the effects of dexmedetomidine on peripheral~     nerve blocks, spinal but up to date no knowledge is available on the impact of~     dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery~   "
59166|NCT02282774|"~     To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on~     postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for~     vitreoretinal surgery.~   "
59167|NCT02282761|"~     The study will be conducted as a randomized, double-blind, parallel-group,~     placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an~     acute exacerbation of psychosis.~   "
59168|NCT02282748|"~     The planned research project is a prospective population-based cohort study, similar to the~     well-known Framingham study in the United States. So far, there is no similar research~     project in Switzerland.~      It is planned to start with an initial cross-sectional examination of four Swiss~     municipalities (Buttisholz LU, Glarus Süd GL, Lostallo GR and Cama GR) in 2014.~     Cross-sectional follow-up examinations will be performed after 5 and 10 years and in 10-year~     intervals thereafter.~      The examinations embrace a broad spectrum of measurements (for details the investigators~     refer to the study protocol).~   "
59169|NCT02282735|"~     Parental decision-making for children with advanced cancer is complex. Many parents have~     overly optimistic beliefs about prognosis and as a result choose aggressive measures even at~     the end of life, which are associated with greater suffering. Yet most parents wish to limit~     suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer.~     These findings suggest that parents do not always have the information they need to make~     decisions that reflect their preferences.~      The proposed study will evaluate parental decision-making in advanced cancer, addressing~     gaps in the literature in 3 important respects. 1) Previous work on decision-making for~     children with advanced cancer has typically looked at decisions at one point in time, often~     asking parents to reflect on decisions after the child's death, even though parents'~     understanding of prognosis and decisions about care evolve over time. We will evaluate~     parental decision-making for advanced cancer over time. 2) Existing work focuses on~     aggressive end-of-life care as the worst possible outcome. However, some parents wish to~     pursue aggressive measures even when they recognize that the child has little chance for~     cure. We will evaluate the extent to which parental decision-making is informed and~     consonant with preferences, regardless of whether decisions lead to aggressive or palliative~     care. 3) Previous studies have focused on groups of different childhood cancers, making it~     difficult to ascertain whether differences in decision-making reflect differences in~     diseases, options for care, or parent preferences. We will focus on a single disease,~     relapsed neuroblastoma, as a model for parental decision-making.~   "
59170|NCT02282722|"~     Patients are routinely asked to sign an informed consent document prior to starting~     chemotherapy, indicating they understand the risks and benefits of treatment. Although this~     could be a strategic moment to equip patients with information they need to make truly~     informed medical decisions, many patients and caregivers note that these conversations are~     less useful than they could be. The informed consent process and its associated documents~     suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials~     focus on individual drugs instead of regimens; 3) information is presented in written~     instead of alternative written/audiovisual format; and 4) the patient perspective is~     lacking.~      The overarching objective of this project is to develop a library of communication tools for~     the most common chemotherapy regimens used to treat metastatic colorectal cancer. Tools will~     include video clips and written documents that can be readily distributed, modified, and~     customized. This toolkit will be crafted in collaboration with oncologists and patients~     living with gastrointestinal cancer and improves upon existing resources in several ways: 1)~     balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3)~     use of both written and video format, and 4) inclusion of the patient perspective (e.g.~     video clips of patients describing their experience). A panel of oncologist and patient~     stakeholders will evaluate the acceptability of the tools. The investigators will then~     conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves~     the quality of informed consent for palliative chemotherapy. If effective, the tools will be~     amenable to broad dissemination via patient accessible cancer education websites and~     oncology clinics.~   "
59171|NCT02282709|"~     Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell~     response, due to continuous pressure of high viral load. Treatment of chronic HCV patients~     with ASV and DCV will result in a significant drop in HCV viral load. At present, no~     information is available on the immunological effects of treatment with ASV and DCV, nor on~     the early effects of viral load reduction caused by a compound that is thought not to~     possess direct immunomodulatory effects. This information will be crucial for a better~     understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of~     viral rebound or relapses during, at the end of treatment or during the follow up period.~      Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV~     patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.~      Study design: This is an investigator-initiated single center open label study with one arm~     of 12 patients.~      Study population: Adult chronic HCV patients with genotype 1b, who are previous~     non-responders to the treatment.~      Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV~     and once daily a 60 mg DCV for 24 weeks.~      Main study parameters/endpoints:~        1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific~          T cells, NK cells and monocytes~        2. Gene expression levels of leukocyte populations before, during and after treatment~        3. Gene expression levels of the type I IFN signaling pathway on whole blood samples~        4. Serum cytokines levels using multiplex platforms~   "
59172|NCT02282696|"~     This study aims to validate the CARES, a needs assessment instrument which can be used to~     inventorize cancer patients biopsychosocial distress and care needs.~        -  QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package~          containing questions about social-demographic and medical data, the CARES and~          convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression~          Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European~          Organisation for Research and Treatment of Cancer Quality Of Life Core 30~          (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week~          after the first questionnaire package participants have to fill in the CARES a second~          time and answer some questions to evaluate the feasibility of the CARES.~        -  QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and~          other (ex-) cancer patients who not have to fulfill the criteria of age and cancer~          stage can participate in a focus group interview. In these focus groups the content~          validity and preferences on psychosocial screening in care are discussed.~   "
59186|NCT02282514|"~     Non-myeloablative regimens (as the investigators use herein) are designed to maximally~     suppress the immune system without destruction of the bone marrow stem cell compartment.~      When using a non-myeloablative regimen recovery occurs without infusion of stem cells and~     the stem cells are autologous. While not necessary for recovery, stem cell infusion may~     shorten the interval of neutropenia and attendant complications. Thus in reality there is no~     transplant only an autologous supportive blood product.~      Based on our encouraging results of non-myeloablative hematopoietic stem cell~     transplantation, for patients with multiple sclerosis and chronic inflammatory demyelinating~     polyneuropathy, the investigators will investigate the role of non-myeloablative~     hematopoietic stem cell transplantation for patients with SPS who require assistance to~     ambulate.~   "
59173|NCT02282683|"~     Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year~     mortality. Currently, there was no evidence-based therapy such as mechanically assisted~     circulatory support available in China. The investigators found glucocorticoid treatment~     such as prednisone could improve cardiac performance, potentiate renal responsiveness to~     diuretics in such patients. Therefore, it could be used as bridge therapy to help ACE~     inhibitors or beta blocker titration. With its help, most of the patients with stage D heart~     failure could be titrated to higher dose of ACE inhibitors and beta blockers during~     hospitalization. However, the efficacy of long-term, low-dose of prednisone use in such~     patients with limited life expectancy remain unclear. Therefore, the investigators designed~     this study to observe whether putting low-dose of prednisone on the patients with stage D~     heart failure for long term could further improve their survival. All patients will receive~     prednisone treatment during hospitalization and receive maximum tolerated guideline-directed~     medical therapy (GDMT). After discharge from hospital, the patients will be randomized to~     receive long-term, low-dose prednisone treatment or standard GDMT.~   "
59174|NCT02282670|"~     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group~     clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the~     non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic~     gastritis.~   "
59175|NCT02282657|"~     Pathophysiological, experimental and clinical data suggest that an 'ultraprotective~     mechanical ventilation strategy may further reduce VILI and ARDS-associated morbidity and~     mortality. Severe hypercapnia induced by VT reduction in this setting might be efficiently~     controlled by ECCO2R devices. A proof-of-concept study conducted on a limited number of ARDS~     cases indicated that ECCO2R allowing VT reduction to 3.5-5 ml/kg to achieve Pplat<25 cm H2O~     may further reduce VILI.~   "
59176|NCT02282644|"~     The recent data suggest that cancer cells at the origin of prostate cancer metastases can be~     detected in an early stage. Available techniques allow phenotypic analysis of cancer cells~     in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study~     on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker~     , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor~     of metastatic progress. In this new study the investigators will analyze antibody panel by~     cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer~     patients.~   "
59177|NCT02282631|"~     The aim of this study is to investigate whether an incentive scheme is a feasible approach~     to increase walking/cycling to school.~   "
59178|NCT02282618|"~     Although current pharmaceutical therapies have improved the survival rate in heart failure~     it remains a fatal disease and is associated with a poor 3-year survival. Increased~     sympathetic activity found in patients with heart failure plays an important role in the~     pathogenesis and development of the disease[Provide reference]. Excessive activation of~     sympathetic tone contributes to arrhythmogenesis, increased cardiac wall tension, and~     platelet aggregation, promoting a vicious cycle[What cycle? Elaborate. ] in these~     patients.~      High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac~     sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has~     accumulated clinical experiences from thousands of cases. His anecdotal experience indicates~     that the method can favorably improve intractable angina, dilated cardiomyopathy, and~     advanced heart failure. Though the method has been used to treat patients at our center for~     many years, there has been no prospective trial of its effects on cardiovascular function,~     or its efficacy to improve clinical outcomes.~      The investigators propose to investigate the immediate physiologic effect and clinical~     effectiveness of HTEA in treating heart failure.~   "
59179|NCT02282605|"~     Study to determine the efficacy, safety and tolerability of two concentrations of XF-73~     nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in~     eradicating nasal carriage of Staphylococcus aureus.~   "
59180|NCT02282592|"~     The role among metabolic syndrome and breast cancer risk is not well understood and must be~     further explored. The objective of this study is to evaluate the association between~     metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast~     cancer patients and controls without malignant disease, matched for age (±5 years) and~     menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and~     triglycerides test. Waist circumference and blood pressure were measured using standardized~     procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006)~     definitions. Cases and controls were compared in relation to the presence of diagnosed MetS~     (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and~     according to each metabolic abnormality cutoff point.~   "
59181|NCT02282579|"~     The purpose of this retrospective observational study was to analyze the effect of targeted~     therapies administered as second-line treatment after failure of pazopanib as well as~     increase the amount of information available on efficacy and safety of pazopanib as a~     first-line therapy in practice usual for the clinical treatment of metastatic Renal~     Carcinoma.~   "
59182|NCT02282566|"~     This study investigates whether a protein-nutrition beverage can increase muscle protein~     synthesis to a similar magnitude as a control beverage.~   "
59183|NCT02282553|"~     This is a pilot prospective single blind controlled trial comparing magnetically steerable~     gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper~     gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.~   "
59184|NCT02282540|"~     The purpose of the study is to establish wether a contrast medium applied to the middle ear~     can be used to diagnose pathology in the auditory tube. We will examine patients with and~     without middle ear disease with CT after the application of an iodine based contrast medium.~   "
59185|NCT02282527|"~     Grifols Therapeutics Inc. is conducting a multi-center, randomized, double-blind, crossover~     study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha1-PI~     compared to the currently licensed product, Prolastin-C, in subjects with Alpha1-Antitrypsin~     Deficiency (AATD).~   "
59187|NCT02282501|"~     Enteral alimentation is the preferred modality of support in critical patients who have~     acceptable digestive function and are unable to eat orally, but the advantages of continuous~     versus intermittent administration are surrounded by controversy.~      This prospective, randomised study was designed to compare two enteral feeding methods with~     respect to changes in levels of leptin and ghrelin in ICU.~   "
59191|NCT02282449|"~     Patients with cancer often require intravenous chemotherapy for long periods of time.~      Ensuring that these patients have safe and reliable access to the veins for chemotherapy is~     challenging, and sometimes a medical device is required to administer the chemotherapy into~     the veins.~      A totally implanted venous access device, or port, is implanted under the skin of the arm~     and is attached to a small plastic catheter that enters into the veins. This device can be~     punctured with a needle when needed for treatment or testing.~      Some types of these vein ports can rapidly inject fluids (power injection), and can be used~     for follow-up imaging studies, such as computed tomography, that are required to follow~     cancer treatment effectiveness. There are no publications of randomized patients discussing~     the impact of power injection upon TIVAD complications and device longevity for arm~     implantation. The investigators propose to compare the effectiveness of power injectable~     against non-power injectable ports to determine if they have different clinical performance~     and complications. Our results will impact the care provided to cancer patients.~   "
59192|NCT02282436|"~     Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality~     worldwide. Its prevalence is in progression and COPD is expected to become the fourth~     leading cause of death by 2030. COPD is characterized by periods of stability interspersed~     with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which~     patients deteriorate, sometimes to the point of requiring immediate medical assistance.~     Although most patients eventually recover, repeated episodes of exacerbations may accelerate~     COPD progression. Exacerbations may further compromise the integrity of limb muscles by~     promoting further loss in muscle mass and strength.~      The overall objective of this substudy is to elucidate how an acute COPD exacerbation may~     affect limb muscles.~   "
59193|NCT02282423|"~     The goal of this study is to understand how and why insulin resistant individuals respond~     differently to exercise as compared with insulin sensitive individuals at the skeletal~     muscle and gene expression level.~   "
59194|NCT02282410|"~     Based on the successful pioneer work of Dr Nilsson and her colleagues in Sweden that started~     in the late 1950's, prophylaxis is recommend as the standard of care for boys with severe~     haemophilia by WHO and World Federation of Hemophilia (WFH). The efficacy and safety of~     prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been~     confirmed in well-designed clinical studies.To keep the factor level above 1%, the standard~     dosage for patients with severe hemophilia A is 20-40 Units /kg/infusion (average 30 Units~     /kg) every other day or three times a week. This dosage has a very high consumption of~     factor, up to 5000-6000 international unit(IU)/kg/year. The high consumption of factor and~     cost present a major barrier to use the standard prophylaxis in many countries particularly~     in the developing world.~      But after the Recombinant Human Coagulation Factor VIII for injection (ADVATE) Patient~     Assistance Program(Golden Key) was launched in 24 Apr 2014 in Nanjing China, the~     affordability of patients was solved and many patients will get more chance to receive~     standard prophylaxis.~      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and~     QoL outcomes in subjects using standard prophylaxis under the conditions of routine~     practice.~   "
59195|NCT02282397|"~     Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves~     glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood~     glucose (SMBG) testing, who are not at target glycemic control.~   "
59196|NCT02282384|"~     The proposed pilot study will provide needed data to establish the feasibility of a~     conducting a large randomized controlled trial as to the effectiveness of the use of~     oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.~   "
59197|NCT02282371|"~     This is a phase 1b study, which means that the purpose of the study is to establish the~     maximum dose of a pill drug called BYL719, when given with a standard treatment for patients~     with head and neck squamous cell cancer.~   "
59198|NCT02282358|"~     The purpose of this study is to learn if the study drug mocetinostat can slow the~     progression of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup~     of their cancer. The potential side effects of mocetinostat will also be studied.~   "
59199|NCT02282345|"~     The goal of this clinical research study is to learn if talazoparib can help to control~     breast cancer that has a BRCA mutation (genetic change). The safety of talazoparib will also~     be studied.~   "
59200|NCT02282332|"~     The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by~     Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction~     in the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation~     in patients already on long-term statin therapy undergoing non-urgent PCI. It is~     hypothesized that the treatment with ticagrelor following PCI will lead to a significant 20%~     reduction in the lipid pool as measured by NIRS/IVUS at follow-up when compared with~     baseline imaging, suggesting a reduction in inflammation and stabilization of the lipid core~     in atherosclerotic lesions not treated during the index procedure.~   "
59201|NCT02282319|"~     The primary objective of this double blind randomized study is to determine the effect of~     dexmedetomidine on onset and duration of the sensory and motor block and on the influence on~     bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that~     sensory block will significantly be prolonged by dexmedetomidine administered by both the~     spinal and the intravenous route. The investigators do not expect a significant difference~     in motor block duration between intravenous or spinal administration. Secondary outcomes are~     micturition problems, duration of analgesia and the occurrence of side effects such as~     sedation and hypotension.~   "
59202|NCT02282306|"~     There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to~     ameliorate the problem have largely focused on increasing the accessibility of naloxone, an~     opioid antagonist that is effective in OOD reversal. Individuals who have experienced a~     non-fatal OOD are at risk for additional overdoses and yet there are no interventions that~     specifically target this high-risk population. To address this gap, the investigators have~     developed the Tailored Telephone Intervention delivered by Peers to Prevent Recurring~     Opioid Overdoses (TTIP-PRO). The overall goal of the present study is to conduct a pilot~     evaluation of the TTIP-PRO. The research literature suggests the need for an intervention~     targeting patients experiencing a non-fatal OOD.~   "
59203|NCT02282293|"~     This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women~     living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women~     between 12 and 28 weeks gestation will be randomized to receive enhanced malaria~     chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo.~     Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of~     age to which the mothers were randomized. All women will receive daily~     trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health~     guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be~     considered a study drug only in infants and children beginning 6 weeks after cessation of~     breastfeeding and upon exclusion of HIV infection. Women and their children will be followed~     for 36 months after delivery. In a subset of the study population, the investigators will~     conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP~     and EFV. The investigators will also measure HIV-related outcomes among the women enrolled~     in the study. The investigators will test the hypothesis that for HIV-infected mothers and~     HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected~     pregnant women and their children will reduce the incidence of malaria among children from 0~     to 24 months of age and improve the development of naturally acquired antimalarial immunity.~   "
59204|NCT02282280|"~     Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in~     rachianesthesia among a general surgical population.~   "
59205|NCT02282267|"~     This study was proposed to validate the efficacy of gefitinib as first-line therapy in~     advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA. As such,~     patients without enough tissue for EGFR mutation detection can also have opportunity to use~     EGFR-TKI as first line therapy. Meanwhile, this study was also proposed to explore the best~     intervention time of anti-resistant drugs (such as AZD 9291, a T790M inhibitor) through the~     quantitative and dynamic analysis of EGFR sensitive and resistant mutation in plasma cf-DNA~     during EGFR-TKI treatment process.~   "
59206|NCT02282254|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone and~     dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study~     in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal~     hypoglycemia.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating overnight glucose levels compared to single-hormone closed-loop strategy.~   "
59207|NCT02282241|"~     Delirium is a common complication of illness especially among the elderly with serious~     sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric~     emergency has key features including acute onset, fluctuating level of consciousness, poor~     attention and cognitive deficits with a presentation which may include hallucinations and~     delusions.~      A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin~     is a widely available natural health product with evidence in normalizing circadian rhythms~     and sleep. There is also preliminary evidence that melatonin can be used to prevent the~     development of delirium in hospitalized patients. We hypothesize that daily administration~     of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing~     for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison~     subjects.~   "
59208|NCT02282228|"~     An open study evaluating the sensitivity and specificity of a microwave-based device,~     Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements~     on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched~     group of healthy volunteers.~   "
59209|NCT02282215|"~     The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra~     supportive care measure after induction chemotherapy for patients with acute myeloid~     leukemia (AML).~   "
59210|NCT02282202|"~     The purpose of this study is to evaluate the safety and efficacy of four times daily~     Positive Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals~     with bronchiectasis and chronic obstructive pulmonary disease (COPD) with chronic sputum~     production. The investigators hypothesize that four times daily positive expiratory pressure~     using the Aerobika ® will significantly improve dyspnea, movement of mucus, St. George's~     Respiratory Questionnaire (SGRQ) score, and six-minute walk distance (6MWD) after three~     weeks of four times daily administration.~   "
59211|NCT02282189|"~     The purpose of this study is to evaluate the safety and efficacy of four times daily~     oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) use over 4 weeks in individuals~     with stable chronic obstructive pulmonary disease (COPD). The investigators hypothesize that~     daily oPEP use will significantly improve St. George's Respiratory Questionnaire (SGRQ)~     score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1)~     after four weeks of four times daily administration.~   "
59212|NCT02282176|"~     The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of~     bronchopulmonary dysplasia in preterm neonates.~   "
59213|NCT02282163|"~     Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV~     EBD on non-contrast 2D echocardiography. Imaging conditions will represent those in routine~     clinical practice and will include LV EBD with harmonic imaging modality.~   "
59214|NCT02282150|"~     Despite optimized hydrocortisone replacement regimes, many patients with adrenal~     insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients~     report high fatigue levels at certain times during the day. A modified-release~     hydrocortisone has been shown to improve QoL, particularly fatigue, in patients with primary~     AI. However, it is unknown, if the same effect can be observed in patients with secondary~     AI. Further, no studies have evaluated the effect, taking into account the diurnal variation~     of fatigue. A novel survey method termed Ecological Momentary Assessments (EMA) has the~     potential to provide reliable measurements of diurnal variations in patient-reported~     outcomes, such as fatigue. We will compare the effect of modified-release compared to~     conventional hydrocortisone on fatigue in patients with secondary AI due to pituitary~     disease, and hereby assess the feasibility of EMA as outcome in future large-scale~     randomised clinical trials (RCTs).~   "
59217|NCT02282111|"~     This is a single-blinded randomized control trial trying to compare the effectiveness of~     diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs)~     of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to~     either get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with~     needle knife (SINK) technique. This is of grave importance because the diagnosis of the~     myriad types of SETs is made histologically requiring a good sample.~   "
59218|NCT02282059|"~     This study is a multi-center, prospective, non-interventional (NI) study evaluating the~     safety and efficacy of sunitinib in Chinese patients with progressive, unresectable,~     advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100~     adults with progressive advanced or metastatic well-differentiated unresectable pNET will be~     recruited in China hospitals. Each subject will be followed up overall survival (OS) time or~     the date of withdrawal and subjects who remain alive after study completion will have their~     OS time censored on the last date known to be alive. Eligible subjects will be enrolled to~     receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily~     dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will~     be treated until disease progress, unacceptable toxicity, withdrawal from the study at their~     own request, or until the final analysis for the study is performed. The NI study will~     capture observations that will be used for evaluating the safety profile of sunitinib,~     including: subject demographics, medical history and medications. Safety assessments,~     treatment data and any other laboratory examination results, which were done according to~     routine clinical practice, will be collected at all visits.~   "
59219|NCT02282046|"~     This study is designed to understand the impact of glycemic control in patients with type 2~     diabetes on dental implants under long-term function. It is hypothesized that poor glycemic~     control will not have significant effects on implant-related outcomes over longer periods of~     time.~   "
59220|NCT02282033|"~     The purpose of the study is to evaluate the safety and performance of the Moderato System by~     implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who~     also have hypertension, in order to reduce their blood pressure.~   "
59221|NCT02282020|"~     Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum~     based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA)~     mutated ovarian cancer who have progressed at least 6 months after the last platinum based~     chemotherapy. Patient should have received at least 2 prior lines of platinum based~     chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.~   "
59222|NCT02282007|"~     More and more people suffer from stress-related illness and ailments that can greatly affect~     the individual's experienced quality of life and sense of coping since pain, physical,~     mental and social functioning are closely linked. Many of these people will seek primary~     care for help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP)~     performed by physiotherapists in primary care.~      Data shows that for the first three months of 2009, 42% of patients were referred to NPMP~     had a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and~     comprehensive pain problems. Many of the patients also had emotional difficulties, but~     without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a~     psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are~     represented, but the majority of patients were treated for anxiety and depression.~      The investigators want to let people who have had NPMP treatment to consider what effect the~     treatment has given, measured by separate registrations of quality of life, pain, physical,~     mental and social functioning.~   "
59223|NCT02281994|"~     The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing,~     compared with standard conservative care, in subjects 50 years of age and over diagnosed~     with Type II odontoid fractures, and this effect will be evident by 6 months post-injury.~     Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and~     CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active:~     placebo control) to either the active or control device for 4 hours a day for 6 months.~     X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture~     healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan~     will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck~     pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study~     subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive~     (placebo) Orthofix Cervical-Stim Model 2205OD device.~   "
59224|NCT02281981|"~     Arterial Stiffness: As a recognized independent indicator of cardiovascular risk,~     maintaining low levels of arterial stiffening is important to cardiovascular health.~     Increases in arterial stiffening results in elevated systolic and mean pressure and it is~     correlated with various cardiovascular conditions such as left ventricular hypertrophy,~     ischaemic heart disease, and myocardial infarction. In contrast, decreased arterial~     stiffness improves ventricular-vascular coupling, ejection fraction, and cardiac output.~     Arterial stiffness is linked to inflammation and oxidative stress. Both inflammation and~     oxidative stress are elevated during DOMS (delayed onset muscle soreness), a state brought~     on by muscle damage often incurred during strenuous exercise. Recent studies have shown that~     a single bout of eccentric exercise can produce acute arterial stiffness during recovery.~     However, anti-oxidants/anti-inflammatories may be effective in reducing the extent of damage~     by decreasing oxidation and inflammation. Curcumin is a powerful antioxidant that could act~     as an anti-inflammatory and diminish the effects of the downhill run. In addition, eccentric~     damage generates a prophylactic protection lasting up to six weeks. The nature of the~     downhill run is primarily eccentric in nature. Therefore, repeated bouts may have diminished~     DOMS development. Any reduction in stress by either the prophylactic repeated bout effect or~     the Curcumin supplement, should attenuate the increase in arterial stiffness due to the~     reduction in inflammation.~   "
59258|NCT02281526|"~     Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with~     moderate hepatic impairment and healthy controls. The trial consisted of a screening visit,~     a treatment phase and a follow-up visit. All subjects were to be treated with study~     medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and~     safety assessments were performed.~   "
59225|NCT02281968|"~     The purpose of this study is to investigate if it is possible to decrease opioid consumption~     in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal~     inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo~     controlled study with two groups of patients: one getting NSAIDs to take at regularly~     scheduled times plus a traditional prescription for opioid medication and one receiving the~     traditional prescription for opioid medication and a placebo. Patients will be assigned to a~     group from a computer-generated program. Neither the patients nor their doctors or nurses~     will know what group they are in, only the pharmacist will have that information. Patients~     in both groups will have the opportunity to take opioid medications if the pain becomes~     unmanageable.~   "
59226|NCT02281955|"~     The purpose of this research study is to learn about the effectiveness of using~     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated~     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.~     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment~     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is~     performed afterwards. This standard regimen causes a lot of side effects and long term~     complications. This study is evaluating whether a lower dose of radiation and chemotherapy~     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in~     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.~   "
59227|NCT02281942|"~     Low self-control has been associated with a number of unhealthy behaviors with low treatment~     success. Alternative non-pharmacological approaches have the potential for enhancing~     self-control. This pilot study will investigate if the practice of yoga and/or health and~     wellness education improve self-control in the context of nicotine addiction, and will set~     the stage for larger clinical trials using behavioral interventions to supplement or replace~     existing treatments and increase the rates of recovery from disorders in which low~     self-control is a susceptibility factor.~   "
59228|NCT02281929|"~     Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for~     28 days. However, about 25-35% of patients do not take benefit from this treatment and die~     within the 6 months following the diagnosis. Numerous trials have evaluated the impact of~     several strategies in association with corticosteroids. None of them has shown an~     improvement in survival (primary endpoint) as compared to corticosteroids alone.~      The project is based on an approach never tested in a randomized controlled trial in severe~     alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2~     months). This approach is based on animal and human studies.Antibiotics are effective in~     animal models and in other circumstances characterized by liver failure such as~     gastrointestinal bleeding related to portal hypertension. The interest of studying this~     population is emphasized by the frequency of infections in these critically ill patients.~     Antibiotics will be administered before the development of any infection, as it is likely~     that these patients present with mesenteric bacterial adenitis without systemic signs of~     infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and~     treatment is given for 30 days.~   "
59229|NCT02281916|"~     This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28~     Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease~     (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule~     from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental~     evidence of its anti-inflammatory properties, the investigators hypothesized that~     administration of P28GST could protect against recurrence after intestinal resection surgery~     in CD.~   "
59230|NCT02281903|"~     The aim of this study was to compare the TrueCPR feedback device (with metronome) to~     standard basic life support (BLS) in terms of the quality of single rescuer pediatric~     resuscitation. Therefore, our hypothesis was that there would be no difference between both~     CPR methods in terms of chest compression quality parameters.~   "
59231|NCT02281890|"~     Neonatal sepsis is an important determinant of adverse neurodevelopmental outcome. The~     investigators seek to investigate whether neurodevelopmental outcome following neonatal~     sepsis differs according to whether or not the diagnosis is confirmed by culture. In a~     secondary analysis of all 3493 infants included in the International Neonatal Immunotherapy~     Study (INIS) randomized controlled trial of intravenous immunoglobulin for neonatal sepsis,~     the investigators will evaluate neurodevelopmental outcomes according to whether or not the~     sepsis was culture-proven. The primary outcome is death or major disability at two years. In~     secondary analyses the investigators will determine neurodevelopmental outcomes according to~     the causative organism identified. Greater understanding of the impact of culture-positivity~     on long-term outcomes in the setting of clinical neonatal sepsis is essential to better~     inform parents about the future prospects of their child and to guide patient follow-up.~   "
59232|NCT02281877|"~     The overall goals of this work are: 1) to elucidate alterations in gene expression and~     downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain~     quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for~     improved maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES)~     utilization. Furthermore, this investigation seeks to expand previous findings regarding~     attenuation of strength and functional performance deficits with NMES application to better~     understand how altered gene expression influences muscle function.~   "
59233|NCT02281864|"~     Children who are hospitalized are especially vulnerable to the effects of tobacco use and~     dependence among their caregivers, and they are more likely to be exposed than children who~     are not hospitalized. Hospitalization is an important teachable moment for health care~     providers to intervene with tobacco dependent parents, and help them reduce their child's~     exposure, potentially improving outcomes after hospitalization, and their future health.~     Understanding the best way to approach and intervene with these families will provide the~     investigator with the necessary information to create a sustainable intervention that can be~     disseminated to hospitals across the country that provide pediatric care, and to ultimately~     make a significant improvement in the health of children.~   "
59234|NCT02281851|"~     This study will investigate whether increased habitual intake of antioxidant supplements~     effects the concentration of endogenous antioxidants, the response of antioxidants to~     exercise, and differences in oxidative damage compared to a non-supplemented group.~   "
59235|NCT02281838|"~     The vast majority of intracerebral hemorrhage (ICH) patients present with elevated blood~     pressure(BP). Management of BP is controversial with two competing rationales. There is some~     evidence that hyperacute treatment may improve outcomes by reducing the rate of hematoma~     expansion. Physicians have been reluctant to reduce BP early after ICH onset, fearing~     reduced cerebral blood flow (CBF) will increase ischemia and increase the risk of further~     damage. Other confounding mediators to further ischemic injury following ICH include~     increased platelet activity, withdrawal of antithrombotic therapy, endothelial dysfunction,~     inflammation and hypercoagulability.~      This study is phase II of the ICH-ADAPT study. The investigators hypothesize that aggressive~     antihypertensive therapy will alter the natural history of heamatoma growth, improving~     outcomes after Intracranial Hemorrhage (ICH). The previous phase I ICH-ADAPT study has~     established the safety of early BP treatment.~      The investigators have designed a phase II study in which ICH patients are randomized to~     aggressive versus conservative BP treatment using a deferred consent procedure. An adaptive~     randomization will be used to treat BP to < 140 mmHg SBP or < 180 mmHg SBP. Treatment must~     be implemented as soon as possible after radiological confirmation of diagnosis.~     Antihypertensive therapy must begin within 6 hours of symptom onset. The patient will be~     re-imaged 24 hours later. The patient will have continuous non-invasive BP and heart~     rate(HR) monitoring for a minimum of 24 hours. Antihypertensive drug use and dosage will be~     recorded with BP and HR. Patients will be monitored regularly until study completion. MRI's~     will be done at 48 hours, day 7 and day 30. This imaging will help to detect ischemic~     changes that may occur. Blood will be collected at the same time as the MRI. Blood analysis~     will be done to possibly identify biomarkers that may be putative mediators of ischemic~     injury in ICH patients.~   "
59236|NCT02281825|"~     The present study will explore a new approach to ongoing evaluation and monitoring of~     fluctuations in personality traits via commercial video games. The aim of this longitudinal~     study is to examine the influence of everyday life event on video games performance as a~     function of individual differences in gaming behavioral patterns. focusing on the ongoing~     performance vacillations of the patient on commercial video games will offer insights in to~     possibly new generation of real time assessment medium of ongoing behavior.~   "
59237|NCT02281812|"~     Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure~     widespread accepted in the treatment of different tumors, especially in the liver but its~     benefit is not yet well-known in breast cancer.~      Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to~     reduce the proportion of positive margins.~      Methodology: The investigator propose a single-center, single-blind, phase I and II~     randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing~     the potential adverse effects in three stages: initial,intermediate and final. Phase II:~     Randomized clinical trial, 2 parallel groups with 37 patients in each one.~      Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group:~     conventional surgery with lumpectomy. The number of positive margins in both groups, and the~     need of extending margin resection will be assessed intraoperatively. Inclusion criteria:~     women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique,~     visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin.~     Patients will be followed up for a period of two years to assess cosmetic result, short~     -term and long -term complications and recurrences.~      Expected results: The cool-tip (cluster) ablation method reduces by at least 30% the risk~     of intraoperative extensions for positive margins during lumpectomy compared to conventional~     surgery in breast tumors with a diameter < 2 cm.~      Therefore this procedure may reduce the risk of second surgeries and the removed volume of~     tissue.Consequently the final cosmetic result should be improved.~   "
59238|NCT02281799|"~     Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) were developed over 50 years~     ago by Gertrude Elion and George Hitchings and were initially used clinically in the~     management of childhood leukemia and organ transplantation.~      The first case report of 6-MP use in inflammatory bowel disease (IBD) was from 1962 , and~     since then the use of thiopurines has been well established in the management of moderate to~     severe IBD.~      Thiopurines offer an inexpensive and effective treatment option for maintenance of remission~     of IBD in comparison to biological agents which may be 30 times more expensive .~      Although 50-60% of IBD patients respond to thiopurines, a significant proportion of patients~     will not tolerate them due to various adverse effects . The adverse effects of thiopurines~     may be dose related, patient related or idiosyncratic.~      The immunosuppressive effects of thiopurines also increase the rates of opportunistic~     infections.~      Thiopurines are also associated with a higher rate of malignancies, particularly a malignant~     Burkitt-like lymphoma, related to Epstein-Barr virus infection . Other adverse effects of~     thiopurine relate to allergic phenomenon.~      An idiosyncratic adverse effect of thiopurine use is acute pancreatitis (AP).~      Acute inflammation of the pancreas defined by INSPPIRE criteria:~      requiring 2 of:~        1. Abdominal pain compatible with AP~        2. Serum amylase and/or lipase ≥ 3 times upper limits of normal~        3. Imaging findings of AP~      Drug induced AP is the assumed diagnosis when no other cause of AP can be found, the patient~     is taking a drug known to be associated with AP, and symptoms resolve after drug~     discontinuation. If pancreatitis re-occurs on re-exposure, the drug is definitely considered~     the cause.~      While drugs are considered a rare cause of AP and most cases are mild and self limited ,~     there is an 8 fold higher risk of AP in IBD patients treated with AZA . Thiopurine induced~     AP is usually detected within 4 weeks of starting treatment.~      However in the case of thiopurine induced AP, there has been no clear understanding of the~     mechanism.~      Thiopurine induced AP is generally considered an indication to cease thiopurine therapy, due~     to the assumed risk of recurrence of AP on reintroduction.~      There exists several case reports and anecdotal evidence that reintroducing thiopurines~     following an assumed thiopurine associated AP can be well tolerated.~      The investigators hypothesize that AZA and/or 6-MP can be safely reintroduced in the~     management of IBD patients following thiopurine-induced pancreatitis.~      If in the past the patients were treated with AZA, they will now be commenced on 6-MP, and~     if in the past they were treated with 6-MP, they will be commenced on AZA.~   "
59239|NCT02281786|"~     This is a single center, randomized, investigator/subject blind, single ascending dose,~     placebo-controlled, parallel study that will evaluate the safety, tolerability and~     pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive~     in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration~     of the study is 16 weeks.~   "
59240|NCT02281773|"~     The objective of the study is to investigate the efficacy, safety and tolerability of four~     different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients~     with schizophrenia on stable antipsychotic treatment.~   "
59251|NCT02281617|"~     Patients experience problems with their memories from a variety of causes. There has been~     much work showing that the use of low tech devices, such as notebooks or diaries, can help~     patients remain independent. More recently, the use of electronic devices, such as digital~     voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids~     could potentially be carried out by a smartphone or tablet using inbuilt functions such as a~     calendar or maps, as well as through downloadable apps, such as medication reminders. The~     investigators have surveyed the investigators patients to show that many of them already own~     smartphones and this number has dramatically increased in the last year. This project aims~     to investigate the feasibility and efficacy of using smartphone and tablet apps as memory~     aids in a clinical setting.~   "
59252|NCT02281604|"~     The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line~     filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.~   "
59253|NCT02281591|"~     Single centre, open-label, randomised study in four parallel groups of healthy volunteers~   "
59241|NCT02281760|"~     Erdheim-Chester Diseases (ECD) is a very rare non-Langerhans cell histiocytosis of unknown~     origin and pathogenesis. It has been reported mainly in adult males over the age of 40~     years, although cases have been reported in females as well. Children are rarely affected.~     Mutation of the BRAF gene, specifically BRAFV600E, has been recently identified in 50% of~     Erdheim Chester lesions in a French cohort. This somatic mutation is believed to be the~     driver mutation in positive cases. The clinical characteristics of ECD range from~     asymptomatic to multisystemic involvement; longitudinal progression and natural history are~     becoming better understood. ECD commonly affects the bones, kidneys, retroperitoneal space,~     skin and brain. If untreated, the disease progresses rapidly, causing fatal outcomes due to~     severe lung disease, chronic renal failure, cardiomyopathy and other complications. The~     diagnosis of ECD relies upon imaging studies and specific pathologic findings in biopsies of~     affected organs, i.e., fibrosis and infiltration of tissues with foamy histiocytes,~     lymphocytes, and plasma cells. Immunohistochemistry reveals cells positive for CD68 and~     CD163 and negative for CD1a, with 20% positivity to S-100. There is no standard treatment~     for ECD, although chemotherapy, radiation, stem cell transplantion, alpha-interferon,~     anakinra, imatinib and sirolimus have been proposed. The recent discovery of the BRAFV600E~     mutation in several ECD patients has opened a new area for treatment options. Vemurafenib,~     an FDA approved BRAF inhibitor for the treatment of patients with metastatic or unresectable~     melanoma with the V600E mutation, binds to this form of mutated BRAF causing protein~     inactivation. The use of vemurafenib in patients with ECD has been reported in 3 patients~     who experienced remission of the disease, and is currently being studied in the U.S. and~     Europe as monotherapy. Tumor/disease resistance to vemurafenib has occurred in melanoma and~     other cancers, although it has not been reported in patients with ECD. In this protocol, we~     propose to clinically evaluate ECD patients with the BRAFV600E mutation and administer~     combination therapy with dabrafenib, a BRAFV600E inhibitor, and trametinib, an inhibitor of~     MEK, downstream of BRAF. Screening for possible contraindications will be made prior to the~     administration of the first dose. With this trial, we will determine the safety,~     tolerability, and efficacy of dabrafenib and trametinib in patients with ECD who harbor the~     BRAFV600E mutation. Dabrafenib 150mg will be given twice daily p.o.; trametinib 2mg will be~     given once daily p.o. Patients will be seen 1 week, 1 month, 2 months, 4 months, and 6~     months, 8 months, 10 months and 12 months to complete a oneyear trial.~   "
59242|NCT02281747|"~     Background:~      - Orthopedic procedures are common in the United States. These include joint replacement and~     spine surgeries. Researchers want to study data about these procedures over time. They want~     to see if treatment has gotten better. They also want to find ways to change the care that~     people get before and after they have these procedures. These changes may lower the risk of~     problems people can have during and after treatment. They may also improve people s results.~      Objectives:~      - To study a series of questions about surgery, medicine, treatments, and outcomes for~     orthopedic procedures.~      Eligibility:~      - Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2012.~      Design:~        -  Researchers will look at data for people ages 20 100.~        -  No new participants will be used in this study.~        -  The study will last 4 years.~   "
59243|NCT02281721|"~     The purpose of this observational post-marketing registry will be to collect and analyze~     safety, effectiveness, and quality of life outcomes, during and after treatment with the~     Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and~     analyzed.~   "
59244|NCT02281708|"~     Researchers developed the nomogram which evaluate the risk of recurrence after surgical~     resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram~     showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those~     stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of~     adjuvant chemotherapy and perform the study to prove this hypothesis.~      Applying the nomogram, the patient scored lower than 104 is categorized into low risk group~     and is to be grouped as the observation group which adjuvant chemotherapy will not be given.~     The high risk group patients (the nomogram scored larger than 104) are randomly divided into~     the treatment group and the observation group. Then, the clinical result on the recurrence~     between the observation group and the treatment group will be compared.~      - Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen~     which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days~     before and the after the estimated day are permitted as allowance.~      Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each~     cycle, every 3 weeks.~      Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3~     weeks.~   "
59245|NCT02281695|"~     The purpose of this study is to determine the differences in oxygenation and decarboxylation~     between two weaning processes.~   "
59246|NCT02281682|"~     A multi-centre randomised controled single blind clinical phase IV trial with the aim to~     determine the most effective treatment in terms of lesion reduction, costs and patient~     satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with~     photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and~     ingenol mebutate (IM) gel.~   "
59247|NCT02281669|"~     Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or~     Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local~     treatment available is intralesional (IL) Pentostam injection. During the current study the~     investigators will monitor the adverse effects of this treatment and will follow up the~     recovery of the lesions after Pentostam injections.~   "
59248|NCT02281656|"~     Ulnar nerve compression at the elbow is a common problem and can significantly affect hand~     function in severe cases. The current, standard treatment is Ulnar nerve decompression with~     or without transposition (moving the ulnar nerve to a site where there is less compression).~     In severe compression, the clinical results after this surgery are typically poor. Distal~     transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve~     (anterior interosseous nerve to ulnar motor fascicles) have been suggested to supercharge~     or augment hand muscles while nerve axons regenerate from the level of the elbow after~     decompression/transposition. In fact, this treatment is becoming widely adopted without~     clear evidence that it changes outcomes. The investigators propose to prospectively compare~     the effectiveness of ulnar nerve decompression/transposition versus~     decompression/transposition and distal nerve transfer.~   "
59249|NCT02281643|"~     This study will determine the influence of doxycycline treatment against Wolbachia/M.~     perstans on immunity against concomitant mycobacterial infections in healthy M. perstans~     infected individuals. In this regard, the investigators will perform a community-based~     randomized controlled trial (Phase 2a) in Asante Akim North District. A cohort of 200~     participants who are contacts of patients with Tuberculosis or Buruli ulcer, of both sexes~     with no clinical condition requiring long-term medication but connected with Mansonella~     perstans will be investigated for the effect of doxycycline on microfilaria, the immune~     response and development of mycobacterial disease.~   "
59250|NCT02281630|"~     The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to~     determine its optimal dose in Chronic Constipation (CC) patients.~   "
59259|NCT02281513|"~     Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be~     approached to enroll in a 6 week pilot intervention. This study will look at the barriers~     and facilitators to increasing physical activity, improving dietary/nutritional intake, and~     improving sleep.This study will offer support and information for people with SLE to~     increase their physical activity, improve their dietary/nutritional intake, and improve~     their sleep and will utilize a smartphone application to self-monitor changes in these~     behaviors.~   "
59260|NCT02281500|"~     Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics,~     Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients with~     Congenital Afibrinogenaemia~   "
59261|NCT02281487|"~     The purpose of this study is to determine whether a tubectomy during hysterectomy for benign~     gynaecological conditions does not result into a premature menopause.~   "
59262|NCT02281474|"~     This pilot study will test Nilotinib's ability to alter the abnormal protein build up in~     Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib~     at different doses for 6 months. Patients will then be tested to see if there is change in~     three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded~     protein changed in the fluid around their brain and spine. 3) Have inflammatory markers~     changed in the patient's blood and fluid around their brain and spine. If successful, this~     drug could be used to slow down or stop the progression of disorders that involve abnormal~     collection of misfolded proteins. However, the main purpose of this pilot study is to check~     for the safety of using this medication at this level.~   "
59263|NCT02281461|"~     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV~     prevention. The Government of Rwanda was the first country to implement the PrePex and acts~     as the leading Center of Excellence providing training and formal guidelines.~      In support of efforts to scale up male circumcision, readily available data have been~     applied to estimate the potential cost and impact of scaling up medical MC services in~     Rwanda to reach 80 percent of adult, children and newborn males by 2015. Infant and children~     male circumcision ensures that the wound will be healed before sexual activity begins, and~     thus reduces the risk of HIV transmission during healing period.~   "
59264|NCT02281448|"~     Single centre, two-way crossover, randomised, open-label study in 20 healthy female~     volunteers.The volunteers received an oral single-dose of a combined contraceptive~     containing with an oral once daily dose of 1200 mg of BIA 2-093~   "
59265|NCT02281435|"~     It is well known from a range of observational and epidemiological studies that the lifetime~     risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60%~     and by up to 73% in post-trial observation. Numerous papers on the topic have been published~     over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan~     countries.~      Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011,~     suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80%~     coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions~     between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up~     would result in averting 3.36 million new HIV infections through 2025. In addition, while~     the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025,~     it would result in net savings (due to averted treatment and care costs) amounting to~     US$16.51 billion.~      To date, there are over 38 million adolescent and adult males in Africa that could benefit~     from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely~     scale up a surgical procedure in resource limited settings.~   "
59266|NCT02281422|"~     Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of~     subjects with various degrees of renal function based on creatinine clearance~   "
59267|NCT02281409|"~     The purpose of this study is to find out what effects, good and/or bad, KW-0761, an~     investigational drug, has on the patient and their cancer.~   "
59268|NCT02281396|"~     The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine （MRC-5~     Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen~     methods (1-1-1-1-1) vaccination.~   "
59269|NCT02281383|"~     This is a phase II study. This means that BCG therapy has already been found to be safe in~     humans. The investigators just want to see if using more treatments works better.~   "
59270|NCT02281370|"~     A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to~     support the use of these drugs together in subjects, such as those with severe aplastic~     anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate~     the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I,~     open-label, randomized, three-period cross-over study in healthy adult subjects. The study~     consists of a screening visit and three treatment periods. All subjects will be randomized~     to receive one of the three treatments in each treatment period separated by washout periods~     of 3-10 days. The total duration of a subject's participation in the study from screening to~     final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment~     periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at~     least 10 subjects per sequence (total 30).~   "
59271|NCT02281357|"~     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study~     to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid~     dependent Asthma.~   "
59272|NCT02281344|"~     A single-centre, open-label, study using induced blood stage malaria infection to~     characterize the activity of MMV390048 against early Plasmodium falciparum blood stage~     infection.~   "
59307|NCT02280889|"~     Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years,~     surgical excision was proposed to the patients because transformation into a malignant skin~     tumor (melanoma) was feared. Recent data proof that the risk for malignancy was~     overestimated. Nowadays still a lot of patients express their wish for surgical removal out~     of aesthetic reasons and psychological impacts. Many patients and families experience~     stigmatization because of the nevus. To proof a medical indication for surgical removal the~     investigators want to evaluate the quality of life and stigmatization before and after nevus~     surgery.~   "
59330|NCT02280590|"~     Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with~     hyperlipidemia~      - 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose,~     noninferiority, multicenter, phase 4 design~   "
59273|NCT02281331|"~     As we age we tend to lose muscle mass and strength. These losses contribute to the increased~     incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of~     independence and reduced quality of life in the elderly. As the number of seniors increases~     worldwide, it is becoming more and more important to develop strategies to counteract this~     loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple~     lifestyle modifications are the most potent defense strategies. Exercises such as weight~     lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts~     of vigorous aerobic exercise interspersed with period of rest, are the most effective in~     promoting gains in muscle mass and strength. Additionally, components of foods like whey (a~     protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to~     independently increase strength. In this study, we are looking to determine how much we can~     increase muscle strength in older men who are put on an 12 week exercise training program~     that combines weight lifting and HIIT, and who consume a daily supplement that contains whey~     protein, creatine, calcium and vitamin D.~   "
59274|NCT02281318|"~     This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate~     the efficacy and safety of mepolizumab adjunctive therapy in participants with severe~     eosinophilic asthma on markers of asthma control. The overall intent of the current study is~     to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL)~     and other measures of asthma control, including lung function.~      Participants who meet the predefined criteria will be randomised to receive either~     mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780~     participants with severe eosinophilic asthma will be screened to ensure the randomisation of~     544 participants (272 participants per treatment group) into the study.~   "
59275|NCT02281305|"~     Restoring the patency of the coronary vessels and providing the ischemic myocardium with~     reperfused blood can cause additional tissue damage. A key element of ischemia and~     reperfusion (I/R) injury and major determinant of the evolution of damage in the affected~     myocardium is the inflammatory response. The main objective of the study is to evaluate the~     efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory~     response in the reperfused myocardium.~   "
59276|NCT02281292|"~     The purpose of this study is to evaluate the initial safety of intravitreal (IVT) LKA651 and~     potential for use alone or in combination with Ranibizumab ophthalmic solution (Lucentis®)~     for the treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.~   "
59277|NCT02281279|"~     This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide~     when combined with rituximab and to see how well this combination works in treating patients~     with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to~     treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in~     different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth~     of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with~     romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.~   "
59278|NCT02281266|"~     Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative~     resection.~   "
59279|NCT02281253|"~     The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary~     fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients~     with or without metabolic syndrome.~   "
59280|NCT02281240|"~     Hemostatic disorders are common and potentially fatal complications in patients undergoing~     hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and~     prevention of these complications. The investigators undertook this prospective study to~     determine the incidence, predictor factors, specific pathogenesis, management and survival~     specially for patients with thrombotic and bleeding complication to better improve outcomes.~   "
59281|NCT02281227|"~     To evaluate the effects of skin compression with an indicator at the needle entry point on~     radiation exposure time of fluoroscopically guided transforaminal epidural block in obese~     patients~   "
59282|NCT02281214|"~     The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the~     primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted~     treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs)~     confer remission in some patients, but use of the EGFR-TKIs is limited to patients with~     adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment~     has become an increasingly important cause of treatment failure. Therefore, identification~     of the molecular components involved could lead to the development of effective therapy.~     Today only a limited number of genetic alterations are studied.~      Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical~     and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND~     mutation detection.~   "
59283|NCT02281201|"~     The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex~     Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy~     induced by vitamin K antagonists in Japanese subjects who require immediate correction of~     international normalized ratio (INR) due to a major bleed or emergency surgery.~   "
59284|NCT02281188|"~     The aim of this registry is to evaluate the incidence, indications and outcomes of patients~     presenting with UTUC in relation to the different treatment modalities used.~   "
59308|NCT02280876|"~     To evaluate the efficacy of ApE coated tablets, on the relapse rate in a group of relapsing~     remitting multiple sclerosis (RRMS) patients, as compared to a placebo group in a period of~     12 months. This study will also determine the safety and tolerability of the drug~     administered over interferon beta vs. administration of a placebo formulation (also over~     interferon) during the evaluation period. Response will be assessed and measured by daily~     self patient recording, monthly clinical neurologist, and every three months serological and~     magnetic resonance parameters.~      Place of Study: National study in Chile with one center at the Regional Hospital in the city~     of Valdivia, including 30 patients enrolled by their respective neurologists.~   "
59331|NCT02280564|"~     FL3X is an integrated diabetes self-management system that incorporates modern cell phone~     technology with behavioral modification approaches to improve diabetes self-management in~     high-risk youth. Utilizing such approaches will increase adherence to diabetes management~     behaviors and improve glucose control by providing increased autonomy over diabetes care.~   "
59285|NCT02281175|"~     Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These~     drugs can have very serious side effects if they are taken over a long period of time. In~     addition to stability, memory, concentration, vigilance, and attention impairments,~     long-term use of BZD is also associated with an increased in hypertension incidence, urinary~     incontinence, coronary artery disease, and renal complications. There are growing evidences~     that long-term BZD use causes physical and psychological dependence as evidenced by the~     withdrawal syndrome.~      The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually~     reduce the medication, either by replacing the BZD by another with a longer half-life, or by~     the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to~     80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms.~     Therefore, it is important to find new strategies to overcome the withdrawal difficulties.~      The aim of this study is to test the effectiveness of a novel psychosocial intervention~     called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus~     providing a new therapeutic tool to physician.~   "
59286|NCT02281162|"~     Schizophrenia and bipolar disorders are major public health problems. The second generation~     anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable~     risk profile as far as movement disorders. However, these drugs are associated with~     clinically significant weight gain and metabolic effects. The underlying mechanisms of these~     side effects are unclear, however in our preliminary studies with schizophrenic patients on~     atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was~     present in about 50% of this population. Given the considerable heterogeneity among the~     patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient~     states, we propose that patients with schizophrenia who gain weight on atypical~     antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in~     patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum~     duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who~     gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients~     who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA~     transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and~     CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels~     of leptin and adiponectin.~   "
59287|NCT02281149|"~     Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to~     95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the~     local recurrence rate after irradiation post- lumpectomy is also associated to a best global~     survival than only the surgery. The adjuvant radiotherapy after partially or totally~     mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer~     Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our~     practices under this breast adjuvant radiotherapy.~   "
59288|NCT02281136|"~     The purpose of this study is to evaluate the potential for systemic exposure of~     aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting~     in patients with multiple actinic keratoses (AK) involving the upper extremities.~   "
59289|NCT02281123|"~     Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early~     joint damage. Approximately 8% of patients have chronic arthropathy resembling to the~     rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in~     Martinique which began in January 2014. It should give a better understanding of arthritis~     and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the~     evolution of chronic arthropathy of CHIK.~   "
59290|NCT02281110|"~     The purpose of this registry is to collect real life information and to document the~     performance and user friendliness of iFR in daily diagnostic practice and treatment~     strategies for MVD patients undergoing cardiac catheterization.~   "
59291|NCT02281097|"~     ﻿Some patients experience high heart rates and symptoms of light-headedness, fatigue,~     headache during standing despite well maintained blood pressure.~      These patient are disabled and can't be in upright position for a longer time. The purpose~     of this study is to test whether electrical stimulation of a nerve through a skin of the ear~     may improve heart rate response and reduce disabling symptoms.~   "
59292|NCT02281084|"~     Evaluate the safety and efficacy of CC-486 and Durvalumab in Subjects with Myelodysplastic~     Syndromes who failed to achieve an objective response post iHMA treatment~   "
59293|NCT02281071|"~     The benefits of microsurgical approaches in periodontal therapy have been described. The~     main focus of this study is to determine if using microsurgical LMCAF technique would~     improve the outcomes of the therapy for the Miller Class III isolated recession-type~     defects.~      Six months results of this study showed that LMCAF with microsurgical approach offered~     better complete and mean root coverage results over macrosurgical LMCAF technique. The~     superior effect of microsurgical approach on post-operative morbidity can make this~     technique more preferable for the patients who expected comfortable postoperative period.~      This study supports that using the microsurgical aproach with LMCAF procedure significantly~     affects the clinical and patient-centered success of treating Miller Class III isolated~     typed defects.~   "
59294|NCT02281058|"~     Vitiligo is a chronic autoimmune disease with evidence of CTLA-4 involvement. We are~     performing a pilot study for the treatment of new onset or actively progressing vitiligo~     with abatacept to determine if weekly self-injections of medication lead to clinical~     improvement in vitiligo lesions.~   "
59295|NCT02281045|"~     It is not known whether the combination of a heparin-grafted membrane plus~     citrate-containing dialysate is a valid alternative to regional citrate anticoagulation.~     This is a cross-over non-inferiority trial comparing these two anticoagulation strategies~   "
59309|NCT02280863|"~     The primary objective of this pilot study is to evaluate the safety and efficacy of a hybrid~     closed loop (HCL) system in participants with type 1 diabetes. This HCL system utilizes the~     PID-IFB controller during the day and night in a closely monitored outpatient environment to~     allow assessment of the practical aspects of using the system for both the participant with~     diabetes and their parent or designated remote monitor.~   "
59310|NCT02280850|"~     Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat~     chronic stable angina (syndrome of blood stasis resistance), and the result will be used for~     the basis of later Ⅳ clinical trial.~   "
59296|NCT02281032|"~     BACKGROUND Nursing homes are important locations for palliative care. Through comprehensive~     geriatric assessments (CGAs), evaluations can be made of the palliative care needs of~     nursing home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that~     evaluates diverse palliative care needs of adults in all healthcare settings. The evaluation~     results in Client Assessment Protocols (CAPs: indications of problems that need addressing)~     and Scales (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate~     and adjust care plans. This study aims to examine the effect of using the interRAI PC on the~     quality of palliative care in nursing homes. Additionally, it aims to evaluate the~     feasibility and validity of the interRAI PC.~      METHODS This study covers phases 0, I and II of the Medical Research Council (MRC) framework~     for designing and evaluating complex interventions, with a longitudinal, quasi-experimental~     pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic~     literature search is conducted. In phase I, the interRAI PC instrument is adapted for use in~     Belgium and implemented on the BelRAI-website and a practical training is developed. In~     phase II, the intervention is tested in fifteen nursing homes. Participating nursing homes~     fill out the interRAI PC during one year for all residents receiving palliative care. Using~     a pretest-posttest design with quasi-random assignment to the intervention or control group,~     the effect of the interRAI PC on the quality of palliative care is evaluated with the~     Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the~     predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI~     PC. Qualitative data regarding the usability and face validity of the instrument are~     collected.~      DISCUSSION This is the first study to evaluate the validity and effect of the interRAI PC in~     nursing homes, following a methodology based on the MRC framework. This approach improves~     the study design and implementation and will contribute to a higher generalizability of~     results. The final result will be a psychometrically evaluated CGA for nursing home~     residents receiving palliative care.~   "
59297|NCT02281019|"~     The purpose of this study is to document indications for cholangioscopy and clinical utility~     of the SpyGlass Direct Visualization System throughout the AMEA (Asia, Middle-East, Africa)~     region when used per standard of practice.~   "
59298|NCT02281006|"~     This study evaluates whether a gel containing sodium thiosulfate deposited via a~     trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity~     caused by the drug Cisplatin among patients with head and neck cancer treated by~     chemoradiation. One ear selected randomly will be treated while the other will serve as~     control.~   "
59299|NCT02280993|"~     To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in~     patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first~     relapse is expected to induce a significantly higher (metabolic) complete remission (CR)~     rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose~     fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP~     salvage only. Increasing the metabolic CR rate prior to consolidation with high dose~     chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve~     progression free survival (PFS) and overall survival (OS).~   "
59300|NCT02280980|"~     Individuals older than 60 years old, discharged after suffering brain stroke with referral~     to the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients~     with positive Romberg test are invited to participate in the trial. Participants will be~     randomized to either the current rehabilitation protocol or to an supplemental intervention~     focused on oculomotor and gaze stability exercises to be applied at home for three weeks.~     Participants will be assessed with standardized, validated tools.~   "
59301|NCT02280967|"~     The last ten years sexually transmitted infections (STI) have substantially increased among~     adolescents. STI can lead to individual suffering and have a negative effect on the future~     reproductive health and also increase the need for health care, thus it is important to~     reduce the number of STIs. HPV vaccination is included in the school-based vaccination~     program since 2012, a catch-up vaccination is offered to older girls and young women aged~     13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and~     the school-based vaccination program has a substantial higher coverage rate. Knowledge is an~     important factor associated with attitude to preventive methods against HPV. In previous~     studies the results indicate that young people have low awareness of HPV and the HPV~     vaccine. Interventions can decrease sexual risk taking and influence the intention to~     receive HPV vaccination and increase the use of condom.~      The aim of this study is to increase primary prevention of human papillomavirus (HPV) by~     promoting HPV vaccination and increase condom use among upper secondary students. The aim is~     also to increase the knowledge about HPV, risk and prevention.~   "
59302|NCT02280954|"~     According to the World Health Organization, cancer is a leading cause of death in men and~     women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains~     the best option for patients presenting with operable Stage I or II cancers, however the~     five year survival rate for these candidates remains at a dismally low. The high rates of~     recurrence suggest that surgeons are unable to completely detect and remove primary tumor~     nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By~     ensuring a negative margin through near-infrared imagery it would be possible for us to~     improve the rates of recurrence from patients and thus overall survival.~   "
59303|NCT02280941|"~     This study is being done to compare the blood flow measurements obtained with the SPECT and~     PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow~     reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise~     information in diagnosing heart problems. SPECT scans, with new camera technology and~     computer software, now have the potential to also give this additional information. The~     study is investigating how well the blood flow measurements from SPECT compared to PET.~   "
59304|NCT02280928|"~     The purpose of this study is to (1) develop and test the effectiveness of home-based~     interventions on dual-task performance in older adults; and (2) determine the~     generalizability of the four trainings (i.e. single-task motor training, single-task~     cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive~     trainings) to novel tasks.~   "
59305|NCT02280915|"~     The study is designed to assess the bioavailability of iron from 4 different iron fortified~     savoury food products~   "
59306|NCT02280902|"~     Infections represent the first cause of death and of morbidity in people treated for~     immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or~     biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these~     infections are poorly understood. There is no recommendation for the prevention and~     treatment of infections in this particular field.~      Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy~     (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic~     and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first~     year after the beginning of the treatment. Thus, the main objective of the study is to~     describe the incidence and risk-factors for infections in people treated with such agents~     for immunologic and inflammatory diseases.~   "
59311|NCT02280837|"~     In this study, the investigators hypothesized that significant proportion of patients with~     coronary artery disease (CAD) has reduced capacity of glucagon-like peptide-1 (GLP-1)~     secretion, which is detectable as blunted response of plasma active GLP-1 level to oral~     glucose loading and that reduced GLP-1 secretory function is associated with increased~     severity of coronary artery stenosis but not with classic risk factors for CAD. To test this~     hypothesis, the investigators will analyze correlation between GLP-1 secretory capacity and~     severity of coronary artery stenosis determined by Gensini Score (GS), an established score~     system for coronary artery stenoses. Additionally, the investigators will analyze~     relationship between level of total GLP-1 and severity of coronary artery stenosis to~     determine how it is different from the active GLP-1 - coronary stenosis relationship.~   "
59312|NCT02280824|"~     Background:~      - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries~     that are too small and are too sick for standard techniques. But they may benefit from a new~     technique called transcaval TAVR. For this technique, doctors make a hole between the~     largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then~     they replace the valve through a tube they put in the groin vein. Then they close the hole~     between the vein and the artery using a device designed to close holes in the heart. This~     study tests the device for this new, off-label use.~      Objective:~      - To further study the safety and effectiveness of transcaval TAVR.~      Eligibility:~      - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are~     not suitable.~      Design:~        -  Participants will be selected by a team of heart specialists and others.~        -  Participants will have a computed tomography (CT) scan with or without contrast dye.~        -  Participants will have blood tests.~        -  Participants will have transcaval TAVR.~        -  Participants will receive the same standard care as for all patients with TAVR.~        -  Participants will also have another CT scan, or an MRI or ultrasound, before they leave~          the hospital, and again after about 30 days and after about 12 months.~        -  Participants will be contacted 1 and 6 months afterwards and will have another visit 1~          year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a~          physical exam.~   "
59313|NCT02280811|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     cancer that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying these specific cells with a type of virus~     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.~     This type of therapy is called gene transfer. Researchers want to test this on human~     papilloma virus (HPV)-associated cancers.~      Objective:~      - The purpose of this study is to determine a safe number of these cells to infuse and to~     see if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with~     HPV and test the toxicity of this treatment.~      Eligibility:~      - Adults age 18-66 with an HPV-16-associated cancer.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti HPV E6 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti HPV E6 cells and aldesleukin. They will~          stay in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
59314|NCT02280798|"~     Do differences in endometrial gene expression exist after different protocols of endometrial~     preparation for embryo transfer? The recent apparition of endometrial receptive arrays~     technology let us know if endometrial is receptive or not in patients with some problems of~     infertility as implantation failure, for that we want to know if this technology would tell~     us if the different kind of protocols for endometrial preparation origin differences that~     could explain some of the founded results.~   "
59315|NCT02280785|"~     Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens~     expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with~     weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive~     hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients.~     Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete~     remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell~     lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported~     although this study enrolled one patient with peripheral T-cell lymphoma not otherwise~     specified (PTCL-NOS).~      CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR)~     superfamily, and it is involved in signal transduction via the activation of the NF-κB~     pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell~     growth, proliferation and apoptosis. CD30 is a non-lineage-specific activation marker~     expressed by scattered B and T immunoblasts. In addition, a subset of cases in virtually all~     T-cell lymphoma entities may also express CD30 but at variable and generally lower levels.~     In fact, a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of~     positive rate of CD30 expression (75%). Moreover, CD30 expression was also documented in the~     tumor sample of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the~     elderly (28.9%, 11/38). Therefore, Brentuximab vedotin may have potential benefits for~     patients with CD30-positive NHL other than anaplastic large cell lymphoma such as~     CD30-positive PTCLs, NOS. Considering the role of CD30 in signal transduction pathway~     associated with tumor growth and proliferation, its expression may be associated with tumor~     aggressiveness. In accordance with this, it is more likely that relapse or refractory NHLs~     may have CD30 expression, and the potential benefits of this promising agent as a salvage~     therapy deserve to be further investigated in these patients who have high risk of treatment~     failure. Thus, we designed a phase II study for relapsed or refractory NHL patients. This~     study is to explore the safety and activity of dosing once every 3 weeks of Brentuximab~     vedotin in patients with relapsed or refractory CD30-positive NHL other than anaplastic~     large cell lymphoma.~   "
59316|NCT02280772|"~     Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus~     konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its~     actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by~     forming a viscous gel of large volume, which increases the feeling of satiety. Current~     evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed~     trials performed in children are needed to assess the efficacy of this modality. We aim to~     systematically evaluate the efficacy of GNN consumption for the management of overweight and~     obesity in children.~   "
60612|NCT02263846|"~     This study is to investigate sex hormones levels of Chinese patients with invasive breast~     cancer.The aim is to analyze biochemical monitoring results of premenopausal and~     postmenopausal patients to facilitate determination of menopausal status and propose~     clinical application.~   "
59318|NCT02280746|"~     BACKGRUOUND: Autism spectrum disorder (ASD) is a common condition. The etiology of ASD~     remains unknown. Recent studies suggest a link between elimination diets and severity of~     autistic symptoms. The possible effects of a gluten-free diet (GFD) on symptoms remain~     unknown.~      AIM: The aim of the study is to evaluate the impact of gluten challenge on the autistic~     symptoms in children with autism spectrum disorders (ASD) and on a gluten-free diet (GFD) in~     comparison to individuals continuing GFD.~      METHODS: 70 children with ASD aged 3-5 and 11/12 remaining on GFD for at least 8 weeks will~     be randomly assigned to gluten-free and gluten-challenge diet.~   "
59319|NCT02280733|"~     More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to~     transmit structured data on all patients followed with chronic wounds and ulcers (e.g.~     diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and~     traumatic wounds). Data are collected at point of care including adherence to wound care~     quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).~   "
59320|NCT02280720|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and~     Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring~     percutaneous coronary intervention.~        1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium~          Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the~          index procedure.~        2. Comparison of intravascular coronary flow reserve measurement to non-invasive~          transthoracic echocardiography-derived coronary flow reserve measurement.~        3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation~   "
59321|NCT02280707|"~     This study, randomized, delivered, and analyzed at the school level, evaluated the effect of~     simple, structural changes to school lunch rooms to make drinking water easier for students~     during lunch time. Half of the schools received posters promoting drinking water and~     installed cup dispensers stocked with cups next to lunchroom water fountains, while the~     other half received no intervention. The intervention outcomes were average water~     consumption and the proportion of students in the lunchroom who opted to drink water, as~     well as the proportion of students with sugary drinks at lunch. No identifying information~     on individual children was collected.~   "
59322|NCT02280694|"~     This study investigates the activity of a new regimen of treatment for patients with~     metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy~     agents and anti-inflammatory agents, when administered orally at low daily doses and without~     planed brakes (Low Dose Metronomic regimen), in contrast with the conventional and already~     exhausted regimens of treatment at Maximal Tolerated Doses (MTD) which required pre-planned~     brakes between treatment days.~   "
59323|NCT02280681|"~     To gain insight by means of a discrete choice experiment questionnaire into characteristics~     of medically assisted reproduction (MAR) with artificial gametes (AGs) valued by couples~     confronted with ovarian failure and their physicians and the trade-offs they make between~     these treatment characteristics.~   "
59324|NCT02280668|"~     The purpose of our research is to investigate the effects of applying cold therapy, or~     icing, to injured muscles in terms of strength recovery and muscle soreness amelioration~     following unaccustomed exercise.~   "
59325|NCT02280655|"~     Transfusion of red blood cells is often used in critically ill patients with low red blood~     cell counts to prevent disease progression and death. Recent studies suggest that the use of~     aged versus fresh red blood cells are associated with worse clinical outcomes. There is~     evidence that red blood cells work with the cells lining our blood vessels to produce a~     variety of substances that normally cause arteries to relax and increase blood supply. Two~     of these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing~     factor (EDHF). The investigators are trying to determine the nature of these substances in~     human beings when they are transfused aged versus fresh red blood cells. The purpose of~     the study is to test the effects of transfusing aged versus fresh red blood cells in~     volunteers with traditional cardiovascular risk factors (high blood pressure, diabetes, high~     cholesterol, and tobacco use) on 1) the degree of relaxation in the arteries and subsequent~     changes in blood flow, 2) blood levels of oxidant molecules, 3) inflammation, and 4) stem~     cells.~      A similar study with healthy volunteers are further described in NCT00838331.~   "
59326|NCT02280642|"~     The purpose of this study was to determine if delayed dosing of recombinant human~     papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls~     elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as~     measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine~     delivered according to the recommended dosing schedule.~      This was a prospective observational study of healthy 9-18 year old female patients~     receiving either a second or third dose of HPV vaccine as part of their well child care.~     Immune responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after~     the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV~     vaccine when administered at naturally occurring longer dosing intervals to the immune~     response to HPV vaccine when administered as routinely recommended.~      In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered~     vaccines by injection were randomized to receive either the HPV vaccine first or their~     concomitantly administered vaccines first. Pain following vaccination was assessed in each~     arm using the Faces Pain Scale - Revised.~      Please note: This record refers only to the observational portion of the study. Please refer~     to NCT00862810 for the results of the randomized portion of the study.~   "
59327|NCT02280629|"~     The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day~     delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission~     in patients with ulcerative colitis (UC)~   "
59328|NCT02280616|"~     The purpose of this study is to assess the efficacy of a low and high dose of a budesonide~     effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction~     treatment of active eosinophilic esophagitis.~   "
59329|NCT02280603|"~     This study is designed to explore the efficacy and safety of DA-4001 after topical~     application in male patients with androgenetic alopecia~      Design : Randomized, double-blind, active-controlled study~      Investigational Product : Finasteride, minoxidil~   "
59332|NCT02280551|"~     Parents can positively influence their children's alcohol use. One strategy they use is to~     provide their children with alcohol, believing it is the best way to teach their children~     how to drink responsibly. The impact of parental supply is not well understood and may be~     unintentionally harmful. This study will research the consequences of parental supply within~     the broader context of parent, child and peer relationships. It will help to determine how~     parental supply influences the different patterns of adolescent alcohol consumption over~     time, providing essential information to help parents prevent alcohol misuse in their~     children. Parents can play a pivotal role in prevention of alcohol misuse, but at present we~     don't know exactly how.~   "
59333|NCT02280538|"~     The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid~     (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic~     effect in primary knee Osteoarthritis (OA) patients.~      The investigators will perform a multicenter double-blind, randomized, placebo-controlled,~     parallel group trial.~   "
59334|NCT02280525|"~     The goal of this clinical research study is to find the highest tolerable dose of immune~     cells called natural killer (NK) cells that can be given with chemotherapy to patients with~     CLL. Researchers want to learn if adding NK cells will be effective in treating the disease.~     The safety of this will also be studied.~      NK cells may kill cancer cells that remain in your body after your last chemotherapy~     treatment. The NK cells will be separated from umbilical cord blood. The device used in the~     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will~     then be grown in the lab to increase the number of NK cells that can be given to you by~     vein.~   "
59335|NCT02280512|"~     In Taiwan, about 75.92% of the elderlies above 65 years old suffered from chronic diseases~     or major diseases, especially in circulatory system. Thus, dramatic hemodynamic change is~     often observed in surgeries in this population. Due to osteoporosis and high-prevalence~     morbidities, trauma with fracture is quite common. These elderlies are more vulnerable to~     have complications, poor prognosis and decompensated organ functions.~      The investigators would like to observe the perfusion of different tissue intra-operatively,~     and to find the correlation with surgical outcome. There are many non-invasive hemodynamic~     monitors nowadays. In our study, the investigators will use noninvasive cardiac output~     measurement(NICOM), and non-invasive transcutaneous near infrared spectroscopy(NIRS) to~     observe hemodynamic change and tissue perfusion. After the surgery, the duration in ICU will~     be recorded. A questionnaire, SF-36, will be mailed to the patients 2 months after the~     surgery to measure the psychometric status.~   "
59336|NCT02280499|"~     Overall study design:~      This study is a prospective, multicenter, postmarket clinical observation to validate the~     PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder~     arthroplasty in terms of radiographic and clinical performance as well as long-term~     survivorship over 10 years.~   "
59337|NCT02280486|"~     This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy~     and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes~     inadequately controlled with metformin monotherapy.~   "
59338|NCT02280473|"~     This study will evaluate the safety and efficacy of a new eye drop formulation in patients~     with dry eye disease.~   "
59339|NCT02280460|"~     To create a local registry for ECMO patients.~   "
59340|NCT02280447|"~     The background of the clinical trial is the overall aim of the World Health Organization~     (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated~     polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to~     become available in low resource third World countries.~      The primary objective of the phase I/II clinical trial is to provide proof of concept (POC)~     that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity~     clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority~     of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3~     IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.~      A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months~     and 5 years of age according to the Danish vaccination program will be included in the~     trial.~   "
59341|NCT02280434|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     CBP-307 following oral single and multiple escalating dose administration in healthy~     subjects.~   "
59342|NCT02280421|"~     ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue~     transplantation may be prescribed ciclosporin to suppress their immune system to give the~     transplant an increased chance of not being rejected. A patient with a compromised immune~     system is more susceptible to infections such as herpes, which will require treatment.~   "
59343|NCT02280408|"~     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola~     vaccine VSV ZEBOV (BPSC-1001) to see if it is safe and to see how it affects people's immune~     system.~   "
59344|NCT02280395|"~     This is a double-blind, randomized, parallel-group, controlled, multi-center study to~     evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared~     to sterile saline (Group B) in adult subjects undergoing abdominal surgery.~   "
59345|NCT02280382|"~     The main purpose of the feasibility study is to identify the patient experience of Femmeze®~     which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for~     women with obstructive defaecation. The investigators want to investigate implementation and~     preliminary effectiveness of the device. The method of investigation will be a pre-post~     intervention design, which involves asking 30 women to use Femmeze® over a period of 8~     weeks. This is an academic study on a labelled indication~     (http://www.nres.nhs.uk/search/?q=medical+devices).~   "
59355|NCT02280252|"~     The need to understand LABC is especially compelling in populations and countries with~     limited resources, where breast cancer incidence is relatively low, but mortality is~     comparably high. In these settings access to appropriate cancer care is characteristically~     limited or often plainly nonexistent. In contrast to economically developed nations, where~     on average fewer than 20% of women present with breast cancer at advanced stages, LABC and~     metastatic disease are the most common stages at presentation in 50% or more women in Latin~     America, Asia and Africa.~   "
59346|NCT02280369|"~     The automated inflatable abdominal binder is an investigational device for the treatment of~     orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The~     purpose of this study is to evaluate the performance of the binder in detecting body posture~     during different types of human motion patterns and activities of daily living, and to~     develop new (and better) ways to detect upright posture. In particular, the investigators~     want to determine if activities of daily living, normally encountered by patients (lying~     down, sitting, standing, walking, and climbing up and down steps), interfere with the~     detection of upright posture used to trigger the device. Studies will be conducted in~     healthy subjects because the main purpose of this study is to evaluate posture detection~     rather than treating orthostatic hypotension.~   "
59347|NCT02280356|"~     The purpose of this study is to test the safety and side effects of~     ultra-hypofractionated radiation therapy when used after brachytherapy (radiation~     implants). This treatment delivers a higher radiation dose with each treatment over a~     shorter period of time.~   "
59348|NCT02280343|"~     Inhalation of dust containing asbestos results in a process of interstitial pulmonary~     fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory~     mechanics describing resistive, elastic and inertial properties. We believe that this~     technique may contribute to the early diagnosis of asbestosis.~   "
59349|NCT02280330|"~     Iodine deficiency remains widespread worldwide with children as among the vulnerable groups~     considering their stage of growth and development. In the Philippines, current data shows an~     optimal status among schoolchildren, however no data exists on iodine status nor intake of~     preschool children. One recent approach to improvement of the vitamin and mineral status of~     the population is home fortification using micronutrient powder or MNP. This contains 15~     vitamins and minerals, including iodine and iron. Current guidelines exist for MNP use to~     improve iron status and reduce anemia among infants and young children 6-23 months old, but~     did not mention use among preschoolers such as those in day care centers. This study,~     therefore, aims to compare the iodine status and growth of day care children given MNP for 6~     months.~   "
59350|NCT02280317|"~     Dose finding safety study of VAL201 in cancer patients.~   "
59351|NCT02280304|"~     The goal of this study is to learn more about how Inner Resources for Veterans (IRV)~     meditation therapy helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild~     traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more~     traumatic experiences. People with PTSD may experience anxiety, pay extra attention to their~     surroundings, involuntarily remember their traumatic experiences, and/or want to avoid~     situations where these symptoms are increased. MTBI may result from being in a blast~     explosion, with pressure from the blast potentially disrupting the brain's structure and~     function. At this time, it is not well known how PTSD and mTBI may affect each other.~      In this study, the investigators will be looking at the behavioral and neurological changes~     (changes in the brain) and the reductions in PTSD symptoms that may come from participating~     in this treatment. The investigators are interested in determining if treatment does reverse~     changes in the brain caused by PTSD and mTBI. To help the investigators understand changes~     in how the brain functions, the participants will complete a functional magnetic resonance~     imaging (fMRI) scan before and after either a 8-week course of IRV or 8 weeks of education~     about PTSD and mTBI. Participation will help the investigators understand how therapy for~     PTSD and mTBI impacts the brain's response to emotions and therapeutic processes.~   "
59352|NCT02280291|"~     Peripheral nerve blocks have been well studied in the literature with generally good results~     for controlling post operative pain following orthopaedic surgery. Regional anesthesia has~     many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well~     as analgesia that continues into the post-operative period. These regional blocks are also~     effective in controlling pain in the immediate post-operative period. However, as the block~     wears off, patients begin experiencing increased pain. Compared to patients treated without~     regional blocks, these patients will often experience a rebound pain--pain occurring 12-24~     hours after surgery that is subjectively worse than that in patients treated without~     regional blocks. Therefore, the investigators propose to use a continuous infusion of~     anesthetic in order to provide sustained pain control post-operatively. Preoperatively,~     patients will be randomized into a single shot peripheral nerve block versus a continuous~     infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual~     Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of~     pain medication taken will be recorded. Patients will be contacted at certain time intervals~     postoperatively to assess their pain scale and pain medication intake. Patients will be seen~     for routine post-operative follow-up visits where they will be assessed for satisfaction,~     pain, residual neurological symptoms, and signs of infection.~   "
59353|NCT02280278|"~     We hypothesize through this randomized, prospective, single center adjuvant study, that~     cytokine-induced killer cell in patients with stage III colon cancer can improve survival in~     this patient population over control. Stage III colon cancer patients can benefit most from~     adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell~     therapy can improve the survival rate of stage III colon cancer patients.~   "
59354|NCT02280265|"~     Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or~     defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of~     care for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The~     efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with~     hemophilia has been confirmed in well-designed clinical studies.To keep the factor level~     above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units~     /kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a~     very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high~     consumption of factor and cost present a major barrier to use the standard prophylaxis in~     many countries particularly in the developing world.~      In China the majority of boys with severe hemophilia A can only pay for on-demand treatment~     or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients~     will get more chance to receive standard prophylaxis.~      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and~     QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for~     injection) standard prophylaxis under the conditions of routine practice.~   "
59356|NCT02280239|"~     The intensive care unit (ICU) team needs to know what effects acetaminophen has in~     critically ill patients. Acetaminophen is better known as Tylenol. It is the drug given to~     reduce fever. Most research that has looked at how safe and effective this drug is, has been~     done with healthy people. Those studies tell us it is safe and works well to bring down~     fever.~      This may not be true for the ICU patient. Some research found acetaminophen was not as good~     at reducing fever as expected in the ICU. Fever helps to fight infection so it may help~     patients get better, but it is also stressful. When you have fever, you to need more oxygen,~     and your heart beats faster. If you have a fever after brain injury, you are less likely to~     make a full recovery. In patients with brain injury, a weak heart or trouble breathing we~     should treat fever. If we can predict how well acetaminophen will reduce fever, we can~     decide if this drug is enough, or other treatments are also needed.~      If you do not have problems with your brain, heart, or lungs, it is safe to not treat fever.~     When you give this drug to treat fever, the body cools itself by sweating, and bringing hot~     blood to the skin's surface. These changes do not affect healthy people. Research suggests~     ICU patients may be at risk for sudden drop in blood pressure.~      Our study will answer 2 questions: 1) When acetaminophen is given to treat fever in ICU~     patients, are they more likely to have a drop in blood pressure? 2) How much will~     acetaminophen reduce fever in ICU patients? We will study ICU patients with a fever who can~     safely get, or not get this drug. This information will help us decide when and how to treat~     fever in the ICU.~   "
59357|NCT02280226|"~     Former studies revealed a distinct pattern of changes in circulation during deliberate~     apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies~     confirmed a massive increase of total vascular resistance as it also happens in shock to~     maintain perfusion of heart, lung and brain. This study is to determine the exact~     alterations of the cardiac function during this reaction, show the redistribution of blood~     volume in apnea and evaluate possible longterm effects on the central nervous system caused~     by repeated apnea via magnetic resonance imaging.~   "
59358|NCT02280213|"~     Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for~     infant intubation during resuscitation with and without chest compressions.~   "
59359|NCT02280200|"~     The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO)~     on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease~     (PAD).~   "
59360|NCT02280187|"~     It is a phase IV, national, multicenter, observational, retrospective study collecting data~     from patient medical files in French spinal centers.~      The aim of the study is to describe the real world use of InductOs in Spine fusion in~     France.~      Approximately 10 French centers will enroll 400 patients. The retrospective review of~     records will focus on patients who have undergone a spinal fusion surgery. Patient should be~     considered for enrollment if he/she has been treated with InductOs between January 1, 2011~     and 31st December 2012.~   "
59361|NCT02280174|"~     Overproduction of intestinally derived triglyceride-rich lipoproteins (TRLs) (chylomicrons)~     has recently been described in type 2 diabetes (T2DM), as is known for hepaticTRL~     (very-low-density lipoprotein) production.~      There is an interest in identifying therapies that would favourably influence postprandial~     concentrations of lipids in T2DM.~      linagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has~     been shown to reduce fasting and postprandial glucose levels in patients with type 2~     diabetes mainly through incretin hormone-mediated improvements in islet function.~      Although clinical studies to date indicate that fasting lipid levels are minimally affected~     by DPP-IV inhibitor treatment, animal studies suggested that DPP-IV inhibition reduce~     intestinal triglycerides (TG) absorption and apolipoprotein (apo) production and increased~     chylomicron catabolism. Interestingly, a recent study supporting this hypothesis showed that~     vildagliptin therapy was able to reduce postprandial intestinal TRL particles in patients~     with type 2 diabetes. Recently, it had reported that sitagliptin treatment significantly~     reduced plasma apoB-48 and TG concentrations in the postprandial state.~      The action of DPP-IV inhibitors may be explained by insulin secretion or action of~     glucagon-like peptide (GLP-1) on metabolism of TRL.~      Therefore, the present study was designed to examine the effects of linagliptin treatment~     (LT) vs standard treatment (ST) on the metabolism of TRL apoB-48 in patients with type 2~     diabetes over a 12 weeks-period.~      The investigators will study the patients in three different moments defined as: Time 0 (2~     weeks before LT or ST, Time 1 (4 weeks after LT or ST), Time 2 (12 weeks after LT or ST).~     With areas under the curve (AUCs) of apoB48 in postprandial conditions.~   "
59362|NCT02280161|"~     This research trial studies germ-line mutations in blood and saliva samples from patients~     with cancer. Studying samples of blood and saliva from patients with cancer in the~     laboratory may help doctors learn more about how inherited genetic mutations can affect~     cancer predisposition (an inherited increase in the risk of developing cancer), their impact~     on treatment response, and their role in cancer development.~   "
59363|NCT02280148|"~     The purpose of this study is to assess the driving and cognitive ability of gastrointestinal~     endoscopy patients at different time points after intravenous anesthesia (propofol for~     example), and to explore whether the driving and cognitive ability have a relationship with~     the blood concentration of propofol or not.~   "
59364|NCT02280135|"~     The purpose of this study is to evaluate the safety of intravitreal injection of autologous~     bone marrow stem cells in patients with retinitis pigmentosa by a prospective,~     single-center, randomized, parallel, double-blind, phase I placebo-controlled clinical~     trial.~   "
59365|NCT02280122|"~     Background: Untreated periodontal disease may influence general health. However, how may a~     physician who is not trained in periodontal probing detect untreated periodontitis?~     Activated matrix metalloproteinase-8 (aMMP-8) in saliva correlates with periodontal probing~     parameters. Thus, sensitivity and specificity of a chair-side test for activated matrix~     metalloproteinase-8 to detect periodontitis was evaluated.~      Methods: Thirty cases (untreated chronic periodontitis; 15 generalized moderate and 15~     generalized severe) and 30 controls (probing pocket depths ≤ 3 mm, vertical probing~     attachment level ≤ 2 mm at < 30% of sites) were examined periodontally. Further, the~     activated matrix metalloproteinase-8 test was performed. The test kit becomes positive with~     ≥ 25 ng/ml activated matrix metalloproteinase-8 in the sample.~   "
80477|NCT02004041|"~     The purpose of this study is to test whether VLY-686 can reduce chronic pruritus in subjects~     with treatment-resistant pruritus associated with atopic dermatitis in comparison with~     placebo.~   "
59366|NCT02280109|"~     This is an open label comparative study of tenofovir gel and film in 10 healthy sexually~     active women without active female genital tract disorders. The women will receive a single~     dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and~     tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics~     of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).~   "
59367|NCT02280096|"~     Twenty four RRMS patients over the age of 18, with similar degree of disability, and with an~     evolution of at last 6 months, who are in first-line immunomodulatory therapy and have a~     stable disease (no more than one outbreak per year) will be included in the present study.~     Patients will be administered a neuropsychological test battery selected for this study and~     divided into two sessions of one and a half-hour each. Emotional state will be assessed with~     the Beck Depression Inventory in a different session. Cognitive impairment is defined as the~     alteration of two or more neuropsychological tests. Patients will be divided randomly into~     two groups where one will receive placebo and the other one 4-AP for a period of four months~     in increasing doses.~   "
59368|NCT02280083|"~     This is a multicenter, double-blind, randomized, placebo-controlled study designed to~     compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and~     safety of treatment in post-stroke subjects with focal wrist, finger and in some cases,~     thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the~     subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if~     thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains~     two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits~     (12 weeks ) after initial injection. During the extension phase, subjects will accept two~     follow-up visit (6 weeks). Outcome measures include changes from baseline at every post~     injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment~     Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change~     from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth~     Scale. Safety parameters will also be measured including adverse events, vital signs (pulse~     and blood pressure) and clinical laboratory tests (haematology, serum chemistry and~     urinanalysis).~   "
59369|NCT02280070|"~     To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in~     patients with resectable rectal cancer, and to identify the more promising regimen.~   "
59370|NCT02280057|"~     The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome~     (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.~   "
59371|NCT02280044|"~     This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating~     the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with~     C. jejuni.~   "
59372|NCT02280031|"~     Low-dose aspirin started in the first-trimester has been associated with a decrease of~     preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple~     pregnancies are considered a risk factor for all those adverse outcomes. The main objective~     of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an~     improvement of birthweight compared to placebo in twin pregnancies.~   "
59373|NCT02280018|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the~     study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944~     in healthy male participants after a single intravenous ([IV] within a vein) dose~     administration.~   "
59374|NCT02280005|"~     This is a prospective, interventional study designed to provide preliminary data on the~     human use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD)~     treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled~     catheter will be studied.~   "
59375|NCT02279992|"~     This is a randomized pilot study to investigate the ability of a phosphodiesterase-V~     inhibitor (vardenafil) to increase the concentration of systemically delivered chemotherapy,~     carboplatin, in patients with recurrent malignant gliomas or metastatic brain cancer. This~     study will also determine the toxicity and tolerability of a phosphodiesterase-V inhibitor~     (vardenafil) in combination with intravenous carboplatin for patients with recurrent~     malignant gliomas or metastatic brain cancer.~   "
59376|NCT02279979|"~     The primary objective of this study is to assess reasonable safety and performance of the~     HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic~     shock requiring stabilization.~   "
59377|NCT02279966|"~     To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on~     cognitive performance (focusing on the aspect concerning speed of processing, executive~     functioning, attention) in working patients with major depressive disorder (MDD).~   "
59378|NCT02279953|"~     To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable~     selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on~     cognitive performance (focusing on the aspect concerning speed of processing, executive~     functioning and attention) in patients who are in partial or full remission from their Major~     Depressive Episode (MDE).~   "
59379|NCT02279940|"~     Atrial fibrillation is a common cardiac arrhythmia and a major risk for ischemic stroke.~     Furthermore the risk of stroke is higher in the first month after transient ischemic attack~     (TIA)/stroke. Rivaroxaban has been approved by Health Canada over period of last two years~     for prevention of stroke and have been found equally effective as oral Vitamin K antagonist.~     The foremost benefits of NOAC are reduced intracranial bleeding risk and does not require~     coagulation monitoring.~      Optimal timing of anticoagulation after TIA/stroke in patients with known non-valvular~     atrial fibrillation is not known. The practice is variable and opinion based. The bias for~     many stroke physicians and neurologists is to start later (after 1-2weeks) to prevent~     hemorrhagic transformation thus possibly exposing the patients to an increased risk of~     recurrence. The product monograph for the drug suggest to wait for variable of 3 to 14 days~     before starting the NOAC (Waiting period:14 days for dabigatran and rivaroxaban, 7 days for~     Apixaban after ischemic stroke and three days after TIA for rivaroxaban). The times have~     been chosen arbitrary.~      The investigators aim to study incidence of symptomatic hemorrhage in patients with~     non-valvular atrial fibrillation who are initiated with new oral anticoagulants early after~     TIA and stroke.~   "
59380|NCT02279927|"~     A prospective study comparing different laser settings used for stone fragmentation during~     ureteroscopy~   "
59381|NCT02279914|"~     This study is a blinded randomized trial to compare two different doses and intervals of~     buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks'~     gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg~     administered 1.5 hours before D&E.~      Primary objective: To compare operative times after two different doses and intervals of~     misoprostol using a non-inferiority design.~      Secondary objectives: To compare the doses and intervals of misoprostol for differences in:~     (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if~     required; (3) ability to complete the abortion procedure without further cervical~     preparation; (4) complications; (5) provider variables including ease of procedure and~     satisfaction with cervical preparation; (6) patient variables including pre-operative side~     effects, post-operative pain, and acceptability~   "
59382|NCT02279901|"~     The primary and well-known challenge with continuous positive airway pressure (CPAP) is the~     incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely~     through emphasizing patient education regarding the risks associated with obstructive sleep~     apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and~     providing a system of accountability through a follow-up process. With the changing~     landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes,~     discovering more automated and self-directed methods of educating and follow-up is needed.~      The investigators plan to investigate the impact of adjunct Web education and automated~     follow-up on CPAP use and other measurements of patient engagement. The specific aims of~     this pilot study are as follows:~        1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy~          in comparison to usual standard of care.~        2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of~          healthcare utilization at 3 months after initiation of therapy in comparison to usual~          standard of care.~   "
59383|NCT02279888|"~     The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of~     the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial~     setting.~   "
59384|NCT02279875|"~     The purpose of this study is to evaluate the mycobactericidal activity, safety,~     tolerability, and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg~     twice per day, 600 mg once per day, 600 mg twice per day and 1200 mg once per day~     administered orally for 14 consecutive days or 1200 mg administered three times per week for~     two weeks in adult subjects with newly diagnosed drug‐sensitive, smear‐positive pulmonary~     tuberculosis.~   "
59385|NCT02279862|"~     The purpose of this study is to examine the safety and effectiveness (how well the drug~     works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients~     with metastatic castration resistant prostate cancer.~   "
59386|NCT02279849|"~     The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and~     evaluate a pilot multi-level communications and pricing intervention to improve access to~     and consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has~     three primary aims: (1) to conduct formative research with representatives of multiple~     levels of the Baltimore food environment (i.e., local wholesalers, retail food store owners,~     and consumers) in order to select key foods for promotion, and determine appropriate~     communications and healthy food price reduction strategies, (2) to pilot the multi-level~     program with 2 local wholesale stores, and 24 small corner stores and their customers, and~     assess program implementation through detailed process evaluation, and (3) to assess impact~     of multilevel health communications and pricing strategies, combined and separately, on~     consumer dietary patterns and food source use, food purchasing behaviors, psychosocial~     variables, food security, and individual weight and height.~   "
59387|NCT02279836|"~     The objective of the study is to gather post-market data regarding the performance of the~     invendo SC20 colonoscope in a real-world US population.~   "
59388|NCT02279823|"~     In this proof-of-concept study, the safety and efficacy of a solution formulation will be~     investigated in male subjects with androgenetic alopecia (AGA) after twice daily application~     for up to 26 weeks.~   "
59389|NCT02279810|"~     The study evaluates the knowledge, attitude and practice about organ transplantation among~     medical students and medical staff.~   "
59390|NCT02279797|"~     The study evaluates the knowledge, attitude and practice about bone marrow donation among~     medical students and medical staff.~   "
59391|NCT02279784|"~     The aim of this study is to compare in patients with critical limb ischemia the efficacy of~     angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in~     terms of restenosis.~   "
59392|NCT02279771|"~     Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and~     is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer~     recurrence and eventually death. In order to prevent this complication a protecting~     diverting stoma is usually fashioned with consequent morbidity due to the stoma and its~     closure and severe impact on patients' quality of life. This prospective, multi-center,~     parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a~     transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal~     cancer surgery thus avoiding the need for a covering ileostomy~   "
59393|NCT02279758|"~     Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence.~     The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has~     demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in~     preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may~     be an alternative treatment for this disease.~      Eligible patients for this study should have metastatic gastroenteropancreatic~     neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with~     metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of~     treatment the efficacy of metformin under the control of disease progression will be~     evaluated. As a secondary outcome the investigator will check the patient adherence to the~     treatment, the control of patient symptoms with functioning neuroendocrine tumor, and~     disease free survival. Also will be performed an analysis of immunohistochemical expression~     of mTOR pathway proteins of these patients.~   "
61604|NCT02250846|"~     The purpose of this study is to determine whether EGFR-TKI can control the development of~     intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain~     metastases, and the difference in progression free survival between exon 19 and exon 21~     mutations.~   "
59394|NCT02279745|"~     This study is an open-label extension study to determine the long-term safety and~     tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2~     study, APD811-003. Patients must have completed the APD811-003 study and must meet~     eligibility criteria for APD811-007.~   "
59395|NCT02279732|"~     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin~     will extend the life of patients with squamous only non small cell lung cancer more than~     placebo plus Paclitaxel and Carboplatin.~   "
59396|NCT02279719|"~     This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608~     in combination with sorafenib, or BBI503 in combination with sorafenib. The study population~     is adult patients with advanced hepatocellular carcinoma who have not received systemic~     chemotherapy.~   "
59397|NCT02279706|"~     Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).~   "
59398|NCT02279693|"~     This study evaluates the dose received by the prostate with in vivo dosimetry when~     delivering image guided radiation therapy (IGRT) associated with intensity modulated~     radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning~     techniques: fiduciary markers or soft tissues.~   "
59399|NCT02279680|"~     The objective of this multidisciplinary project is to explore the deficit of associative~     memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain~     connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has~     been evocated but has never been tested. Hence, the present project will include two~     complementary assessments conducted on a group of adults aged from 18 to 30 with ASD~     compared to a control group matched in chronological age and intellectual quotient. The~     first assessment is devoted to the study of associative memory and its EEG correlates and~     the second focused on the investigation of perceptual strategies related to associative~     memory using the technique of Eye-tracking. Both behavioral and imaging data would provide~     new insights on the relationship between perception and memory in ASD.~   "
59400|NCT02279667|"~     Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9~     males and 9 females). The study consisted of three consecutive single-dose treatment periods~     separated by a washout period of 7 days or more. On each treatment period, the volunteers~     received a single dose of BIA 2-093 800 mg, orally.~   "
59401|NCT02279654|"~     This registry is a prospective, non-interventional, post authorisation safety study for~     patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk~     Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5~     [del(5q)].~      The purpose of this study is to collect additional data about the safety of an oral drug~     (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the~     need of blood transfusions. However, also patients affected by the MDS del(5q) who receive~     other treatments different from lenalidomide can be included in this study, if they agree.~   "
59402|NCT02279641|"~     This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male~     subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics~     (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.~   "
59403|NCT02279628|"~     The cesarean section is considered as a painful surgery during the post operative period.~     Mothers may need to move immediately after the surgery to take care of their babies. This~     may increase the risk of major pain and chronic pain. Thus, excellent postoperative~     analgesia is required so that mothers do not experience pain in caring for their baby.~     Currently, several techniques have been developed to manage postoperative pain related to~     c-section scar such as intrathecal morphine during spinal anesthesia or continuous~     pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never~     been performed and it is still not know if the combination of intrathecal morphine plus~     continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on~     pain relief.~   "
59404|NCT02279615|"~     The purpose of this study is to investigate the safety and efficacy of combination therapy~     involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB~     symptoms in male patients with BPH.~   "
59405|NCT02279602|"~     Subjects achieving a clinical response in study OX4218s with a biomarker reduction or~     symptom response are eligible to enroll in this rollover study to continue once every three~     weeks fosbretabulin infusions for up to one year.~   "
59406|NCT02279589|"~     Immune response analysis after the combination of PCV13 and PPV23 will lead to evaluate if a~     prime with PCV13 help to obtain a good response to repeated dose of PPV23.The~     hyporesponsiveness following the unconjugated vaccine is associated with high polysaccharide~     antigen concentration. Several issues limit the development and recommendation of~     anti-pneumococcal vaccine in adult's patients at risk. Reduced doses of unconjugated~     polysaccharide antigens would bypass the hyporesponsiveness and maintain the expanded~     coverage serotype.~      A better knowledge of immune response following the combination of two vaccines in adults is~     essential. In addition, adults are required to be exposed to repeated doses of~     polysaccharide antigens by vaccine or by natural exposure, it is important to determine the~     extend and duration of any hyporesponsiveness.~      The main objective is to evaluate if non conjugate polysaccharidique fractionated doses~     administered after a conjugate vaccine help to avoid hyporesponse in a schedule with~     repeated injections of pneumococcal polysaccharidique vaccine~   "
59407|NCT02279576|"~     Penile cancer is an uncommon disease, with devastating physical and psychological effects on~     patients. Penile carcinoma even in advanced stages is responsive to several chemotherapeutic~     agents. However, due to the low incidence of penile cancer, no large studies have been~     reported concerning chemotherapy.~      Various single agents were tested for activity en penile cancer in de 70s and 80s. Response~     rates ranged from 10 to 27% with cisplatin, 20 to 21% with bleomycin, and 0-62% with~     methotrexate. These agents in combination were tested in different studies. Other~     chemotherapy schemes have been studied, as combination of cisplatin with 5 fluorouracil with~     or without taxol, and cisplatin plus irinotecan. All of them in limited phase II studies,~     with described higher responses rates in some of them but without results confirmation in~     phase III studies.~      In conclusion, tested regimens so far have not been very successful in advanced stages of~     the disease.~      Antiangiogenic therapy has been demonstrated effective in the treatment of similar cancer~     types as lung and head and neck, so it can be postulated that antiangiogenic therapy can be~     effective in the treatment of penile carcinoma. Pazopanib is a new potent oral~     antiangiogenic therapy.~      Cytotoxic agents, such as paclitaxel, when administered at low doses and frequent intervals,~     may exert antiangiogenic effects, thereby enhancing anticancer activity. Recently,~     combination of pazopanib and paclitaxel administered in a metronomic schedule (80mg/m2~     weekly 3 weeks every 4 weeks cycle) obtained a 40% response rate and an 80% of disease~     control in the first-line treatment of melanoma patients. Treatment was well tolerated.~      As paclitaxel and antiangiogenic drugs seem a very active treatment, combination of~     pazopanib and paclitaxel seems a good combination to be tested in patients with penile~     carcinoma.~   "
59408|NCT02279563|"~     This study is to evaluate the equivalence of generic Azelastine Hydrochloride and~     Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in~     the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of~     generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with~     Dymista™ nasal spray.~   "
59409|NCT02279550|"~     The purpose of this study is to create an institutional and population-based registry of Hip~     fracture in the elderly with a prospective survey based on epidemiological data, risk~     factors, diagnosis, prognosis, treatment, monitoring and survival.~   "
59410|NCT02279537|"~     The purpose of this study is to collect real-life data on patients with wet age related~     macular degeneration (AMD) for whom treatment with Eylea was initiated~   "
59411|NCT02279524|"~     This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study~     designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18~     to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy~     performed in a period of 6 months before entering the study, with overweight or obesity and~     who are pre diabetic or type II diabetic.~      Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg~     tablets and placebo tablets in ratio 2:2:1.~      The subjects will be evaluated at study sites for 11 scheduled visits during one year (52~     weeks). After completion of the study treatment period, the subjects will be followed for an~     additional period of 13 weeks without study medication (until visit 11 (week 65)).~   "
59412|NCT02279511|"~     To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in~     patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and~     adjust the infusion (minimum effective dose) that promotes this metabolic change.~   "
59413|NCT02279498|"~     Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes~     including lipase, protease, and amylase. The purpose of the present study is to provide~     additional efficacy and safety data compared to approved, porcine-derived,~     enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary~     efficacy endpoint of the study will be comparative efficacy measured as the change in the~     coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic~     insufficiency (EPI).~      Liprotamase is stable in stomach and digestive fluids allowing administration in a variety~     of convenient formulations and with a number of foods without enteric coating.~   "
59414|NCT02279485|"~     This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll~     a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence~     between the oral suspension and tablet formulations of perampanel will be evaluated under~     fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet~     formulations will be evaluated under fed conditions. In both study arms, subjects will be~     randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for~     perampanel as either oral suspension or a tablet, and will then receive the alternative~     treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a~     washout of at least 6 weeks between the two treatment periods.~   "
59415|NCT02279472|"~     The purpose of this study is to analysis changes in anterior segment morphology after laser~     peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment~     effectiveness~   "
59416|NCT02279459|"~     The purpose of this study is to utilize dual-energy computed tomography (DECT) to~     investigate changes in tumor iodine concentration in patients with head and neck squamous~     cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard~     CT neck with the added benefit of providing functional information that would only be~     possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI)~     or positron emission tomography (PET) imaging techniques.~   "
59417|NCT02279446|"~     Development of a validated computer-based instrument (software program) for the assessment~     of intermediate visual acuity.~   "
59418|NCT02279433|"~     DS-6051b is an orally administered inhibitor of the tyrosine kinases ROS1 and NTRKs. This~     phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer~     subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also~     assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of~     DS-6051b.~   "
59419|NCT02279420|"~     This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163~     intended to evaluate the safety and efficacy of treating previous sham subjects in the~     Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ~     suture anchors along with diet and exercise). Compliant sham subjects (those who attended~     all primary IDE follow-up visits AND who continue to meet eligibility criteria as described~     in this protocol) will be offered this active treatment after their 12 month unblinding~     visit in the Essential pivotal trial.~   "
59420|NCT02279407|"~     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study~     performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and~     dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as~     measured with magnetic resonance imaging (MRI))~   "
59421|NCT02279394|"~     This research study is aimed to determine the proportion of high risk smoldering multiple~     myeloma patients who are progression free at 2 years after receiving elotuzumab,~     lenalidomide and dexamethasone combination therapy.~   "
59422|NCT02279381|"~     Neonatal mortality has been a notable health issue in Pakistan. Considering the importance~     of the issue and well recognized interventions the investigators are proposing a randomized~     controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a~     neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and~     application of chlorhexidine compared with standard neonatal care coupled with application~     of chlorhexidine and essential neonatal care alone. The investigators anticipate that this~     study will provide an evidence base way forward benefiting the children of Pakistan.~   "
59447|NCT02279056|"~     Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive~     airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP~     treatment may be complicated in patients with co-morbid insomnia. This project evaluates the~     effects of a self-help book for insomnia in patients being treated with CPAP for OSA.~   "
59423|NCT02279368|"~     In Northern India, skewed sex ratios, female feticide and higher child mortality rates for~     girls have become serious concern. The female child mortality as a result of son preference~     have increased during the last several decades. Since families cannot know the sex of the~     fetus due to Indian government policies, they now 'neglect' girl child to ensure there are~     few survivors. Survival chances of second and third daughters are plunging neglecting~     healthcare and nutrition has become tool for death as 'good riddance'.~   "
59424|NCT02279355|"~     The aim of this retrospective study is to overall evaluate and validate preoperative and~     intra-operative risk factors for postoperative pressure ulcers in critically ill~     postoperative patients.~   "
59425|NCT02279342|"~     The purpose of this study is to investigate the effects of febuxostat on coronary plaque~     volume in patients with chronic stable angina and hyperuricemia.~   "
59426|NCT02279329|"~     Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive~     pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history~     will be imaged with CT and MRI for the development of tools to quantify and validate~     longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.~   "
59427|NCT02279316|"~     Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The~     study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home~     strength exercise program (arm 2) against control (no exercise) on the rate of falling,~     quality of life, gait performance and cognitive function. All groups receive vitamin D. In~     addition the study shall test the feasibility of the recruitment and the interventions in~     this target population.~      The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild~     dementia. Participants are recruited by the memory clinic of City Hospital Waid.~      During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12~     month). Despite major efforts the target population is very difficult to recruit and~     adherence to treatment is low. We therefore decided to stop recruitment and to use this~     trial as a pilot trial for future clinical trials of the same topic.~   "
59428|NCT02279303|"~     This randomized controlled trial will test the impact of a patient-navigated,~     anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI]~     and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast~     cancer survivors compared to a control group.~   "
59429|NCT02279290|"~     This randomized controlled trial uses a modularized cognitive behavioral resilience training~     (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma~     psychopathology. Ninety participants with a history of interpersonal trauma during childhood~     or adolescence and mild to moderate distress will be randomized to MCBRT or a health~     education control condition. The primary aims of this proposal are to examine whether~     individuals who receive MCBRT demonstrate increases in psychological resilience, biological~     resilience, and extinction learning compared to those in the control group. This study will~     also explore associations between these psychobiobehavioral risk and resilience factors.~   "
59430|NCT02279277|"~     In this study, the investigators are investigating the effects of physical therapy (PT) for~     treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee~     replacement. Through the examination of patient outcomes, such as pain, stiffness, and~     physical function, the investigators will determine if PT prior to total knee replacement is~     an effective treatment in a patient with high grade OA.~   "
59431|NCT02279264|"~     Objectives:~        1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings~          from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor~        2. To determine what percentage of time the RightSpot Infant pH Indicator could have been~          used to determine the proper placement of the NG tube prior to feedings~        3. To establish normative pH values for neonates~   "
59432|NCT02279251|"~     The study will evaluate two group CBT interventions delivered by school health nurses, in~     cooperation with community psychologist and mental health care personnel, to adolescents~     with mild to moderate levels of anxiety symptoms. The two interventions have different~     intensity (5 versus 10 group meetings). The two group interventions se will be compared to a~     waitlist control group.~   "
59433|NCT02279238|"~     In view of assessing the uphill walking capacity and to provide a functional stress test~     with better sensitivity the investigators need a short term functional stress test over the~     gold standard six minute walk test....~      To demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a~     functional stress test.~      The investigators hypothesize that the investigators three minutes ramp walk test (3MRWT)~     will be superior to the existing six minutes level walk test (6MWT) in the measurement of~     functional capacity of post valve replacement patients.~   "
59434|NCT02279225|"~     Temporomandibular joint dysfunction is described as a multifactorial disease and can be~     directly linked to other diseases, being of structural factors of the Stomatognathic System~     or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular~     Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of~     Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a~     Randomized, Controlled and double-blind, with the intention to treat. In this way the sample~     of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages~     between 35 to 58 years, females who are selected after the inclusion/exclusion criteria,~     will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy~     (FT) group, group of physical activity (A) aerobic and aerobic physical activity +~     Phototherapy Group (FT + A). Will be used as a means of analysis before and after~     interventions the following parameters: Pain: clinical evaluation, evaluation of pain by~     Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still~     we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own~     illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study~     36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with~     polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and~     FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes,~     where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT~     + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive~     the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power).~     Statistical analysis will be compared using the t test intra-group-Student, one-tail and~     paired and can be used the Kruskal-Wallis test, the statistical analysis of significance~     0.05 for both tests.~   "
59448|NCT02279043|"~     This study will look at women's social communication about IUDs (intrauterine devices) and~     their attitudes and behavior related to IUD use. The researchers will design an online~     community where women can talk to each other about their experiences with birth control. We~     will examine whether social exposure to IUD users in this setting is associated with change~     in attitudes and behavior among women who have never had an IUD.~   "
59435|NCT02279212|"~     Previous research on intensive care unit (ICU) survivors shows that rehabilitation is~     challenging, because of patients experiences of disease related problems both under and~     after treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from~     hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other~     symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et~     al 2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that~     28% of intensive care survivors have chronic pain that reduce their health related quality~     of life (Boyle et al 2004).~      The aim of this study is to perform a survey about prevalence of pain type, and which~     consequences this causes when it comes to function and quality of life up to 12 months after~     the ICU stay.~        1. What type of pain has ICU survivors and how do pain change over time, related to~          treatment/rehabilitation and the illness' development?~        2. What is the relationship between different pain characteristic, quality of life,~          anxiety, depression, fatigue, sleep and PTSD in these patients?~        3. What is these patients largest obstacle for good QoL after discharge from hospital?~   "
59436|NCT02279199|"~     The purpose of this study is to find out if gross motor skills of children and young adults~     with bleeding disorders are different from those without bleeding disorders. The~     investigators will use the standardized motor test the Bruininks-Oseretsky Test of Motor~     Proficiency, Second Edition (BOT-2 tm). The second purpose is to establish if history of~     joint disease secondary to bleeding affects gross motor skills.~        1. Participants and setting: Subjects will include up to 100 male youth and young adults,~          ages 4 to 21, recruited from the patient population of the Hemophilia Treatment Center~          at OHSU. A mailing that describes the study may be sent to all potential subjects who~          receive care through the Hemophilia Treatment Center at OHSU. Data collection will~          occur at either clinic visits or in the home. Information, including history of change~          in joint structure and synovium, from existing bleeding disorder repositories at OHSU~          will also be used.~        2. Design and Procedures: Research will be done using a prospective, cross-sectional study~          design to examine any relationship between a diagnosis of bleeding disorder and gross~          motor development. The gross motor ability of children and young adults with bleeding~          disorders who meet the inclusion criteria will be compared to sex-specific normative~          data from a standardized motor test. Information about age, type of hemophilia,~          presence of an inhibitor, type of management used, body composition, range of motion,~          and hand strength will also be collected through direct measurement and chart review.~          The information collected will be entered into a repository. A subject may choose to~          opt out of the repository while still participating in the research study. In addition,~          information from a current hemophilia repository will be compared to gross motor~          ability scores to determine if joint disease is related to skill level in this group of~          people.~        3. Proposed analyses: Two-tailed t tests and logistic regression will be used to determine~          if there are any significant differences.~   "
59437|NCT02279186|"~     In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss~     during and after elective LSCS will be investigated.~   "
59438|NCT02279173|"~     This is a phase 3b single arm, open label, multicenter study describing the percentage of~     time pediatric subjects with ITP have a platelet response while receiving romiplostim,~     defined as a platelet count ≥ 50 x 10^9/L and in the absence of ITP rescue medications in~     the past 4 weeks.~   "
59439|NCT02279160|"~     The study will be conducted as a placebo-controlled, randomized, 22 week double-blind study~     which will include a dose titration period. An additional transition period will occur for~     those patients who elect to enroll into the open-label extension study, APD811-007.~     Approximately 60 patients with PAH will be enrolled.~   "
59440|NCT02279147|"~     RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to~     patients who have obstructive jaundice after operation.~      PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation~     complications in patients with obstructive jaundice .~   "
59441|NCT02279134|"~     This phase III trial is studying how well the combination of chemoradiation or radiation~     works in resected locally advanced cancer of the esophagus or gastroesophageal junction.~   "
59442|NCT02279121|"~     The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution~     vs standard saline solution for primary prevention of central venous catheter-associated~     bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor~   "
59443|NCT02279108|"~     The sentinel node has a fundamental role in the management of early breast cancer.~      Currently, the double detection of blue and radioisotope is recommended. A radioactive~     material requires the presence of a nuclear medicine department and the approval of health~     authorities. In many centers, this technique is not available. The use of blue is easier to~     implement technique. However, allergic reactions and prolonged breast tattoo led many teams~     to stop the practice.~      So in common practice, many center use a single method. However, with a single detection,~     the risk of false negatives and the identification failure rate increased to a significant~     extent and the number of sentinel lymph node detected and removed is not enough.~      Under these conditions, find another method of detection seems crucial. According to the~     literature, the fluorescence method (ICG) is a technique that seems safe and reliable.~      The investigators therefore propose a prospective, randomized study to investigate the~     interest of fluorescence associated with the isotopic method.~   "
59444|NCT02279095|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and~     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue~     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict~     movement by locking joints leading to cumulative loss of function and disability. Mouse~     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists~     such as palovarotene to prevent HO following injury. This 24-month study will (1) continue~     to follow the 40 FOP subjects who completed Clementia Study PVO-1A-201; (2) enroll up to 20~     additional new subjects who have achieved at least 90% skeletal maturity; and (3) evaluate~     the ability of different palovarotene dosing regimens to prevent HO in these subjects.~   "
59445|NCT02279082|"~     A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines~   "
59446|NCT02279069|"~     Stroke patients frequently necessitate walking aids such as 4-point canne. However, the~     4-point canne has to be lifted by the patient which limited gait speed. The adjunction of~     small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to~     walk without having to lift the canne as it will roll over the ground.~      The aim of our study is to compare gait parameters (gait speed and energy cost) with a~     classical 4-point canne and with 4-roll canne.~   "
59449|NCT02279030|"~     The purpose of this study is to assess if Single Photon Emission Computed Tomography (SPECT)~     demonstrating cardiac innervation can be integrated into current electrophysiology voltage~     mapping system and provide improved guidance for ablation of PVCs.~   "
59450|NCT02279017|"~     To assess the feasibility to translate an automated weight loss message intervention to a~     weight loss clinic population.~      Aim 1: To assess feasibility of translating the intervention in a clinic for patients who~     recently completed a structured weight loss program.~      Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months~     through an automated intervention.~   "
59451|NCT02279004|"~     Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and~     melanoma, and is currently used to identify patients for treatment with targeted kinase~     inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and~     cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of~     this study is to prospectively evaluate a blood-based genotyping tool that can quantify the~     presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and~     melanoma. This assay is being studied both as a diagnostic tool for classifying patient~     genotype, and a serial measurement tool for quantification of response and progression on~     therapy.~   "
59452|NCT02278991|"~     Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated~     Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as~     LifeStent) for treatment of long (10-24 cm) lesions in the SFA.~   "
59453|NCT02278978|"~     BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type~     urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have~     failed platinum-based chemotherapy.~   "
59454|NCT02278965|"~     The purpose of this study is to determine whether it is feasible to give a combination of~     Metformin and OMEGA-3 fatty acids for one year to women with a history of early stage breast~     cancer. We will also evaluate whether the metformin and OMEGA-3 fatty acids combination~     causes changes in breast tissue, blood, and mammograms.~   "
59455|NCT02278952|"~     This is a non-interventional cohort study to assess a novel assay to detect excessive or~     insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The~     assay measures mean residual expression (MRE) of genes downstream of NFAT, a transcription~     factor regulated by tacrolimus. The investigators will assess whether MRE levels identify~     subjects at risk for rejection (insufficient immunosuppression) or infection (excessive~     immunosuppression).~   "
59456|NCT02278939|"~     Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have~     one of the highest prevalences of obesity and type 2 diabetes mellitus compared to~     non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented~     in health related research, particularly in diabetes prevention. This proposed pilot study~     is the first clinical trial to assess preliminary estimates of the short-term effect of the~     novel social networking diabetes prevention program lifestyle intervention for this~     high-risk population.~   "
59457|NCT02278926|"~     Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly~     influence blood sugar control in patients with diabetes mellitus on insulin therapy. In~     response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on~     injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no~     imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue.~     Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy~     is characterized and defined by clinical tapping or by ultrasound with multi frequency~     linear probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those~     areas so defined. Patients are reevaluated 3 and 12 months later~   "
59458|NCT02278913|"~     Few randomized studies have focused on the optimal management of non-ICU patients with type~     2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen~     with analogs and human insulins in general medicine patients admitted to a University~     Hospital in Asuncion, Paraguay.~   "
59459|NCT02278900|"~     Aims of study While various communication aids have been evaluated separately, no studies~     have taken a coordinated approach combining aids with different goals to evaluate their~     combined impact. In this study the investigators will use two communication aids; a QPL and~     an audio recording of the consultation. QPLs includes question concerning treatment options,~     but few studies involving QPLs have explored whether QPLs result in patients taking a more~     active role in the consultation. To our knowledge there have not been studies which~     objectively try to explore whether patients receiving QPLs participates in shared decision~     making to a greater extent, except for one ongoing Italian trial of breast cancer patients.~      To explore and describe how communication aids as a QPL and an audio recording of the~     consultation improve the first doctor-patient consultation at the oncology outpatient clinic~     by~        1. Encouraging patients/caregivers to ask more questions, particularly about sensitive~          topics such as prognosis (as an effect of QPL alone)~        2. Increasing shared decision-making (as an effect of QPL alone)~        3. Improving overall satisfaction with the consultation and information retrieved (as an~          effect of both communication aids)~        4. Affecting quality of life/anxiety/depression (as an effect of both communication aids)~   "
59460|NCT02278887|"~     In this randomized controlled phase III study the investigators will evaluate whether TIL~     infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus~     interleukin-2 can result in an improved progression free survival when randomly compared to~     ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be~     performed to evaluate the impact of the TIL treatment on patients and organizational~     processes and cost-effectivity.~   "
59461|NCT02278874|"~     The objectives of the clinical study are to demonstrate the accuracy of our proprietary~     algorithm method to determine the genetic health of the developing fetuses in a multiple~     gestation pregnancy from a maternal blood sample. The long term goal of this study will be~     the development of a method of minimally invasive prenatal diagnosis that has a higher~     sensitivity and lower false positive rate in the intended population (e.g. multiple~     gestation pregnancies) than other currently available screening tests.~      This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated~     with a risk of miscarriage.~   "
59493|NCT02278458|"~     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable~     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic~     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in~     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic~     pancreatic adenocarcinoma.~   "
59462|NCT02278861|"~     Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To~     prevent their development, a study is being conducted with oral isotretinoin and topical~     tretinoin to verify what drug is the most effective and has the best security profile for~     these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens~     will be part of the treatment. The study will have the duration of 10 months. In the first~     four months, the AKs will be counted and treated with cryotherapy (face and arms) and~     sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be~     counted), a new session of cryotherapy will be performed and they will be randomized into~     two groups: one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one~     using tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will~     be done for all 60 patients at the beginning of the treatment with retinoids (isotretinoin~     and tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs~     will be counted again and skin biopsies will be done. Patients in the group ISO (oral~     isotretinoin) also have to make blood tests at the beginning, two months and after six~     months of the treatment. Clinical (AK counting), histological (improvement of parts of the~     skin) and immunohistochemical parameters will be evaluated to see what drug is more~     effective for prevention of AKs.~   "
59463|NCT02278848|"~     Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled~     cavities in the brain. The clinical symptoms are gait disturbance, mental decline and~     incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to~     be able to induce regression of the symptoms in many cases meaning that ICAH is a classic,~     curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting~     cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is~     complicated: improvement is often incomplete and there is no consensus on either how to~     assess the symptoms or how they change after CSF depletion. In consequence, the decision~     whether not to undertake surgery often depends on the neurosurgeon's clinical impression.~      Over recent years, the cognitive profile of patients with ICAH has become better~     characterised and reproducible, objective techniques have been developed to assess motor~     function and CSF flow in the brain.~      The investigators project aims to define the value of these new investigative techniques in~     the positive diagnosis of ICAH, in comparison to current decision-making tools.~   "
59464|NCT02278835|"~     This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques~     to prevent pulmonary collapse based in an score applied in the patients submitted of the~     mitral valve surgery, after their ICU discharge.~      Patients were allocated in groups according their pulmonary function (FVC: forced vital~     capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP:~     maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation;~     respiratory frequency (f); the ability to expectorate and the functional independence.~      The group I was allocated those patients which presented decrease of up to 50% of forced~     vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation~     alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance;~     independence to sit; respiratory. In these patients were randomized for two interventions:~     a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration~     exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive~     spirometer: used Coach® three sets of 10 repetitions.~      Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88%~     SpO2 <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm;~     dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive~     Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation~     valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to~     obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes,~     twice daily, one in the morning and another in the afternoon.~      All of the patients were conducted in effort to mobilize upper and lower limbs. On the first~     day, the patients walked at least 50 meters, by increasing the distance to at least 150~     meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.~   "
59465|NCT02278822|"~     This trial is designed to provide evidence of the efficacy of liposomal glutathione~     supplementation on healthy adults. The investigators anticipate that liposomal glutathione~     supplementation will enhance the levels of blood glutathione and improve the immune~     functions.~   "
59466|NCT02278809|"~     1. Development of a method for parents of primary schoolchildren to teach parents~          parenting skills to obtain health gain in the family through videos and online~          feedback.~        2. Effect- and procesevaluation of this methodology.~        3. Development of an implementation guide together with VIGEZ as primary partner and in~          association with partner organisations on the field.~   "
59467|NCT02278796|"~     In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen~     used prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four~     chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial~     letters are grouped together for BEAM regimen. One of the most common organ damage this~     intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests~     itself in the months after ASCT with increasing shortness of breath and cough, and can~     result in pulmonary fibrosis. The drug bendamustine is used successfully in different~     lymphoma types, and its efficacy in lymphoma therapy is well documented. Moreover~     bendamustine doesn't cause lung injury. Initially experience with bendamustine instead of~     BCNU - in the so-called BeEAM scheme - shows that this scheme is quite effective and well~     tolerated, without lung injury. In BeEAM scheme therefore bendamustine replace the BCNU,~     while the other three drugs are administered in the same dosage and order. The aim of the~     present study conducted at four centers (Bern and Zurich in Switzerland, Vienna and Salzburg~     in Austria) is to compare these two high-dose chemotherapy schemas and to show that the~     BeEAM scheme causes significantly less lung injury than the BEAM regimen.~   "
59468|NCT02278783|"~     This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients~     with recurrent ovarian, primary peritoneal, and fallopian tube cancer.~   "
59469|NCT02278770|"~     In this study, our novel MRI techniques for studying the small bowel will be applied to~     patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be~     determined using MRI measurements. These data will be correlated with measurements of~     adipokines to determine if visceral fat has a specific influence on the severity of~     diverticular disease.~   "
59494|NCT02278445|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package- the Transthoracic~     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung~     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in~     detecting PAH in SSc patients will be assessed in the study.~   "
59470|NCT02278757|"~     Randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65~     years) with Metabolic Syndrome (MS). The sample size was calculated using a formula that~     compares two means, an alpha of 0.05 and a power of 95%. Based on these calculations, we~     established a baseline sample of 118 adults. For the diagnosis of MS, we used the~     classification from the International Diabetes Federation (IDF). 150 patients were screened;~     however, 32 were excluded because they did not meet the criteria. Doctors wrote down medical~     history; nutritionists conducted anthropometry (weight, height, and waist circumference);~     and nurses measured blood pressure and withdrew venous blood for determination of glucose,~     triglycerides, and HDL-cholesterol. After being randomly assigned to one of two groups, the~     control group received a diet with a lower protein content (0.8gr/kg body weight), and the~     intervention group received a diet with higher protein content (1.34gr/kg body weight). Both~     diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a~     caloric restriction of 500 calories less.~      For the intervention group, meal replacements were made with soy protein, and individualized~     menus, controlling the content of calories, protein, carbohydrates, and fat, had more~     control over the total amount of protein consumed daily. Used as a substitute for food, the~     protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water.~     For both groups, the calorie density of the diet was adjusted for the baseline metabolic~     rate of each participant with a restriction of 500kcal/day.~   "
59471|NCT02278744|"~     This is a phase I clinical trial investigating the use of single fraction re-irradiation~     following local progression of spine and cauda equina (L2 to sacrum) lesions that have~     previously received radiation therapy. Patients will be treated with single-fraction~     radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.~   "
59472|NCT02278731|"~     To determine and compare the effects of a training program with Pilates and Facilitation~     Neuromuscular Proprioceptive on balance and function in elderly women.~   "
59473|NCT02278718|"~     This study will be a two-arms study intending to demonstrate superiority of NexoBrid~     treatment over SOC in children with thermal burns. The study objective is to evaluate the~     safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep~     partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to~     standard of care (SOC).~   "
59474|NCT02278705|"~     The purpose of this study is to identify whether specific clinical practices—including,~     body-mass-index (BMI) screening, identifying weight-related conditions (such as high blood~     pressure), and scheduling follow-up visits to reassess progress—will improve the weight~     status of overweight school-age children at one-year follow-up.~   "
59475|NCT02278692|"~     Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder~     seen in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and~     significant morbidity associated with non-healing and extremely painful skin lesions. At~     present, there is no effective treatment for calcific uremic arteriolopathy.~      Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to~     increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of~     vascular calcification. However, the effects of vitamin K supplementation in patients with~     calcific uremic arteriolopathy are unknown.~      The purpose of this study is to conduct a pilot randomized controlled trial to examine the~     effects of oral vitamin K supplementation on circulating levels of anti-calcification factor~     (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic~     arteriolopathy.~   "
59476|NCT02278679|"~     A digital rectal exam proficiency tool, titled the 'DiRECT' was developed based on the~     consensus of 10 experts. The purpose of this study is to validate this tool for use in both~     undergraduate and graduate medical education .~   "
59477|NCT02278666|"~     The aim of the present study is to assess in a real life case list the outcome of three~     different surgical approaches for isolated aortic valve surgery in terms of surgery times,~     morbidity and mortality.~   "
59478|NCT02278653|"~     The primary objective is to describe the functional outcome of patients that choose for~     organ saving treatment.~   "
59479|NCT02278640|"~     This is a prospective, non-randomized, single arm, multicenter, study to assess the initial~     clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during~     total laparoscopic hysterectomy. The study will not modify or influence current surgeon~     technique. Investigators will perform each procedure using the device in compliance with~     their standard surgical approach and product labeling.~      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in~     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,~     calibrated, and/or used in accordance with manufacturer design specifications, product~     instructions and guidelines~   "
59480|NCT02278627|"~     During fthe first postoperative days, physiotherapists supported patients with knee~     replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes~     movements of the leg in active and non active motions, without any help and with an~     arthromotor, and involves walking rehabilitation.~      The investigators would like to complete the physiotherapist's support with manual lymphatic~     drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might~     have a positive impact on time recovery of joint range, on postoperative oedema resorbtion~     and on patient's pain during rehabilitation classes.~      French National Authority for Health specifies there is not a single study assessing massage~     effects on knee replacement, according to current bibliography.~      The investigators purpose is the establishment of a prospective, controlled, randomised~     trial referred as a superiority trial. A total of 98 patients divided in 2 parallel groups~     will be created.~      The study will be in an open-label manner for both patient and physiotherapist involved in~     walk rehabilitation but will be conducted as a blinded study for the investigating~     physiotherapist.~      Inclusion period will be 17 months and the following period will be 6 weeks.~   "
59481|NCT02278614|"~     The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005%~     + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous~     patients initially treated, stabilised by Xalacom® or generics (fixed combination~     Latanoprost 0.005% + Timolol 0.5% preserved eye drops).~   "
61605|NCT02250833|"~     A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the~     pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration~     telmisartan and s-amlodipine in health volunteers.~   "
59482|NCT02278601|"~     Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more~     than 50% of parturients continue to experience pain leading to suffering and increased~     caregiver workload. Women who have increased pain tend to have lower successful patient~     bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have~     dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental~     delivery. Labour pain often escalates and worsens as labour progresses requiring an~     individualized, variable, flexible analgesic regimen. Bolus epidural administrations have~     been shown to improve uniform spread of local anaesthetics with better pain relief, compared~     to fixed background infusions.~   "
59483|NCT02278588|"~     In this investigator-initiated study, we will compare changes in brain cognitive biomarkers~     assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic~     Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B~     inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental~     State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived~     neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients~     and HC over 2.5 years.~   "
59484|NCT02278575|"~     The study will be an open controlled pilot study of 6 patients with early-onset severe~     preeclampsia. Patients will receive Atenativ in addition to conventional therapy The~     patients will be followed up within the study until three days after delivery. Laboratory~     analyses and uterine and umbiliacal blood flow will be determined.~   "
59485|NCT02278562|"~     By 2030 an estimated 2 million people in the US will need dialysis or transplantation for~     advanced kidney failure. An even more disturbing statistic is that mortality in End Stage~     Renal Disease (ESRD) is six times higher than in the general Medicare population with~     adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in~     these patients and is one of the most important determinants of their poor clinical outcome.~      Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein~     energy wasting observed in chronic hemodialysis patients cannot be attributed to any single~     factor. However, irrespective of the specific etiologic mechanisms, it appears that the~     common pathway for all the metabolic derangements is related to exaggerated protein~     degradation relative to protein synthesis (47).~      Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance~     and chronic inflammation, may be the major determinants of protein catabolism in coronary~     heart disease (CHD) patients. There are no studies examining the effects of~     anti-inflammatory interventions and/or insulin sensitizers on protein homeostasis in CHD.~     Due to their established anti-inflammatory and other pleiotropic effects, Interleukin-1~     receptor antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated~     receptors (PPAR) agonist Actos represent two such promising interventions. By modulating~     inflammatory response and insulin signaling through two pharmacological interventions, the~     investigators will have the unique opportunity to clarify mechanisms contributing of these~     two particular metabolic derangements in the development of protein energy wasting observed~     in chronic hemodialysis patients.~      The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin~     resistance influence the development of protein energy wasting in hemodialysis patients.~      Specific Aim: To test the hypothesis that inhibiting inflammatory response by administration~     of an IL-1r antagonist (Anakinra) or increasing insulin sensitivity by administration of a~     PPAR agonist (Actos) will improve net protein metabolism.~      Hypothesis: The chronic inflammatory component of protein energy wasting (PEW) observed in~     hemodialysis patients is, at least in part, mediated by insulin resistance.~      Interim analysis may be performed (no specific plan at this time).~   "
59486|NCT02278549|"~     Low back pain (LBP) is a complex and common problem with major societal repercussions.~     Clinical evaluations, and especially functional assessments, are necessary for proper~     diagnosis and decisions on the most appropriate treatment. The assessment of lumbar~     kinematics has been frequently described. For instance, measures of range of motion (ROM),~     angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some~     differences between healthy subjects and LBP patients. However, recent evidence has~     suggested that models evaluating the TLx are insufficient. In fact, regional differences in~     kinematics have been described between the upper lumbar spine and the lower lumbar spine.~      The aim of this study is to evaluate the differences in spinal kinematics between healthy~     subjects and LBP patients using a multi-segment model of the spine that allows regional~     analysis.~   "
59487|NCT02278536|"~     The objectives of the clinical study are to demonstrate the accuracy of our new NATUS~     diagnostic method to determine the genetic health of the developing fetuses in a multiple~     gestation pregnancy from a maternal blood sample. The long term goal of this study will be~     the development of a method of minimally invasive prenatal diagnosis that has a higher~     sensitivity and lower false positive rate in the intended population (e.g. multiple~     gestation pregnancies) than any currently available screening tests. This will result in~     fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of~     miscarriage.~   "
59488|NCT02278523|"~     Background：Respiratory muscle weakness is observed in chronic obstructive pulmonary~     disease(COPD) patients and contributes to hypercapnia, dyspnoea, nocturnal oxygen~     desaturation and reduced walking distance.During exercise it has been shown that diaphragm~     work is increased in COPD and COPD patients use a larger proportion of the maximal~     inspiratory pressure (MIP) than healthy subjects. This pattern of breathing is closely~     related to the dyspnoea sensation during exercise and might potentially induce respiratory~     muscle fatigue. Inspiratory muscle training(IMT) increases inspiratory muscle strength and~     endurance, and decreases dyspnoea.But the mechanism of IMT still lack of research.~      Purpose：The experiment is aim to compare of the similarities and differences of~     transdiaphragmatic pressure by detecting the transdiaphragmatic pressure of COPD patients~     and healthy volunteers in different intensity of threshold load conditions. Thus investigate~     how inspiratory muscle training works or mechanism in lung rehabilitation programmes of~     COPD.And emerging the theoretical basis of inspiratory muscle training from respiratory~     physiological mechanism.~   "
59489|NCT02278510|"~     Topotecan is a FDA-approved drug when given by intravenous injection, but it is not~     effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is~     a new, investigational device that will be used to deliver topotecan directly into~     participants' brain tumors. One purpose of this study is to determine whether the Cleveland~     Multiport Catheter can be used effectively and safely to deliver topotecan directly into~     brain tumors. This study will also evaluate different doses of topotecan that can be~     delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and~     it will also examine how their tumor responds to treatment with topotecan.~   "
59490|NCT02278497|"~     The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of~     coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera~     and 99mcTc-mibi. 20 patients will have those measurements.~   "
59491|NCT02278484|"~     Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.~   "
59492|NCT02278471|"~     In this study the investigators will examine the effect of the polypill on medication~     adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.~   "
59495|NCT02278432|"~     Introduction. The prevalence of the use of drugs that act on the gastric system has~     increased in the population. Omeprazole is an inhibitor of the protons pump and has a~     widespread use, mainly as a prophylactic to prevent reflux esophagitis, gastric pathological~     hypersecretory conditions, prevention of recurrence of gastric or duodenal ulcers, gastric~     mucosal protection against damage caused by nonsteroidal anti-inflammatory drugs and during~     Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events~     due to abusive use or irrational prescribing, in disagreement with the indication, which may~     cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess~     the risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic~     use of omeprazole in hospitalized patients and to know the reasons for the prophylactic use~     (indicated use or not approved). Patients and Methods. A observational and cross~     pharmacoepidemiological study will be performed from June to November 2014, in the General~     State tertiary referral Américo Brasiliense Hospital. Hospitalized patients will be~     separated into three groups: those who make indicated and approved prophylactic use of~     omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use~     (exposed group 2), and those who do not use the omeprazole (non-exposed group). Patients who~     do not make prophylactic use of omeprazole will be excluded. Patients will have their~     pharmacotherapy monitored and data will be collected daily using an investigation guide of~     the first day of admission and will be included in group 1 or 2, from the first use of~     omeprazole to discontinuation (washout period of seven half-lives or higher). National~     Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) algorithm will~     be used for causality analysis is used. Data will be tabulated according to the presence or~     absence of effectiveness and the presence or absence adverse events in the three groups. The~     odds ratio of adverse events and effectiveness of indicated and approve or not indicated and~     not approved prophylactic use of omeprazole will be calculated. Expected results. It is~     intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with~     or without indication or use approval, and the potential indications, dosage and unapproved~     methods of prophylactic use in omeprazole label.~   "
59496|NCT02278419|"~     The purpose of this study is to evaluate the efficacy of simeprevir in combination with~     sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of~     participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in~     the overall population.~   "
59497|NCT02278406|"~     The purpose of this study is to determine if deep brain stimulation can change brain oxygen~     levels in people with Parkinson's Disease. Measurements will be taken using a non-invasive~     device while subjects are both on and off their medications, and while their stimulator is~     in the on and off setting.~   "
59498|NCT02278393|"~     Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy~     product over a 4-week period in Japanese healthy adults~   "
59499|NCT02278380|"~     This study is initiated to investigate the glycemic index value of seven food products.~   "
59500|NCT02278367|"~     This study is designed to expand the database of 18F-AV-1451 safety and tau binding as~     measured by PET imaging and to provide standardized conditions for 18F-AV-1451 use, data~     collection and analysis to facilitate companion studies including, but not limited to,~     longitudinal studies of aging, depression, and traumatic brain injury.~   "
59501|NCT02278354|"~     Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive~     18F-AV-1451 to explore its use as a biomarker for brain injury related to repetitive head~     trauma and to examine the relationship between clinical presentation and tau deposition.~   "
59502|NCT02278341|"~     This study is conducted to explore a new therapy for anemia in patients with end stage renal~     disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.~     Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The~     purpose of this study is to evaluate if roxadustat is effective and safe in the maintenance~     treatment of anemia in ESRD patients on stable dialysis. Roxadustat will be compared to~     epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.~   "
59503|NCT02278328|"~     Recent evidence from magnetoencephalographic (MEG) studies in ASD have pointed to~     abnormalities (specifically, delays) in auditory evoked neuromagnetic responses (e.g. M100 -~     see Roberts et al., 2010, and mismatch field, MMF - see Roberts et al., 2011) as well as~     abnormalities in the oscillatory behavior of auditory cortex, especially in the gamma band~     (30-50Hz), at rest and in response to simple auditory stimuli (see Gandal et al., 2010 and~     Cornew et al., 2012; Edgar et al., 2013). The local circuitry underlying such evoked~     activity and oscillations, and synaptic transmission in general, requires an appropriate~     balance of excitation and inhibition, mediated by glutamate and GABA, respectively. One~     model of the neural oscillatory deficits in ASD suggests that impaired regulatory control by~     inhibitory interneurons onto pyramidal cells underlies abnormal auditory latency and~     oscillatory electrophysiological measures. As such, electrophysiological deficits are~     interpreted in terms of local circuitry abnormalities, with inferences at the molecular~     level of imbalances in the activity of glutamate and GABA.~      A candidate therapeutic for ASD has been developed - STX209, a GABA-B agonist. Since this~     pharmaceutical targets synaptic activity that has clear electrophysiological correlates, one~     goal of this proposal is to assess the responsiveness (sensitivity to change) of MEG~     measures to acute administration of STX209 at various doses in adolescents on the autism~     spectrum. The study also aims to establish the nature of the putative relationship between~     such electrophysiologic markers and GABA and glutamate levels using MEGAPRESS~     spectrally-edited magnetic resonance spectroscopy (MRS).~   "
59504|NCT02278315|"~     The primary objective of the study is to determine the safety and tolerability of~     I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed~     or refractory multiple myeloma who have previously been treated with, or are intolerant of,~     an immunomodulator and a proteasome inhibitor.~   "
59505|NCT02278302|"~     Study to investigate whether psychomotor performance which is necessary for safety driving a~     car or operating machinery and safely participating in daily life is changed by Aggrenox®.~     Also to investigate whether Aggrenox® impairs performance in combination with alcohol more~     than alcohol alone. Derived from this: Statement on whether a warning for drivers is~     necessary~   "
59506|NCT02278289|"~     The purpose of this study is to compare the efficacy of combining a wrist orthosis with~     either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome~     patients.~   "
59507|NCT02278276|"~     The purpose of this study is to determine the safety and benefits of SG1002, including~     overcoming deficits in circulating hydrogen sulfide and nitrite found in heart failure~     patients, with secondary endpoints focused on improving clinical endpoints.~   "
59531|NCT02277964|"~     This is an observational study to develop new hypothesis regarding the dynamic and safety of~     switching from natalizumab to fingolimod:~        -  Comparison of disease activity (clinical and MRI) during the year after change of~          therapy in comparison to the year before change~        -  Dynamic of onset of disease activity after having stopped treatment with natalizumab~        -  Change of immunological parameters during treatment change from natalizumab to~          fingolimod in comparison to clinical and MRI measures~   "
59508|NCT02278263|"~     Total knee joint replacement surgery can lead to significant blood loss, which can affect~     recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of~     blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of~     debate. Growing interest in the topical application of TXA (directly into the surgical~     wound) has been suggested as an alternative way of administering TXA, and may demonstrate~     similar effectiveness as when it is given intravenously. Therefore, this multicentred,~     randomized controlled trial, aims to investigate the safety and effectiveness of both~     topical and intravenous administrations of TXA in total knee joint surgery. The~     investigators predict that both routes of administration will demonstrate similar results~     when compared to placebo.~   "
59509|NCT02278250|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     doses of single-agent VX-803 administered twice-weekly (BIW) in subjects with advanced solid~     tumors. This investigation is a three part study examining VX-803 alone and in combination~     with carboplatin, gemcitabine, and cisplatin to determine the safety and maximum tolerated~     dose.~   "
59510|NCT02278237|"~     Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million~     hospitalizations in the United States annually1 and COPD is the third leading cause of~     30-day re-hospitalizations.2 Clinical trials have established the efficacy of treatments~     primarily dispensed via respiratory inhaler devices that reduce morbidity and health care~     utilization if they are used correctly.3-4 Unfortunately, the effectiveness of these~     medications in real-world settings is limited by the fact that patients often do not use~     inhalers correctly.5-6 Current guidelines recommend assessing and teaching inhaler technique~     at all health care encounters, including hospitalization.77.5 My work has found that over~     75% of hospitalized patients in an urban, predominantly underserved population misuse their~     respiratory inhalers, highlighting a missed opportunity to educate these patients with high~     potential to benefit.8 Hospitalization, therefore, provides a potential 'teachable moment'~     to correct this misuse.9 My preliminary data indicate that one strategy, in-person~     teach-to-goal (TTG), is effective in teaching hospitalized patients proper inhaler technique~     and is more effective than simple verbal instruction.10~      While TTG is a promising method to improve care for patients who use inhalers, several~     limitations prevent widespread adoption. First, TTG relies on in-person assessment and~     education, as well as training and monitoring instructors to ensure fidelity, making it~     time-consuming and costly. Also, because a single educational session does not ensure~     long-term retention,11-12 post-discharge reinforcement may be needed, which may be~     impractical with in-person TTG. One potential method to surmount TTG's limitations is use of~     interactive video module education (VME), a method that has been used for health education~     in other clinical contexts.13-14 Through iterative self-assessments and video-demonstrations~     on a tablet computer, VME has the potential to be less costly, maintain fidelity, and be~     more easily extended into the post-discharge setting than in-person TTG. However, certain~     questions remain about VME. It is unclear whether VME will yield similar results when~     compared to TTG, or whether urban, underserved patients will have the ability to, and be~     willing to use, VME in the post-discharge setting. Therefore, before widespread~     implementation of VME, it is critical to rigorously develop and test VME for inhaler~     education in the hospital setting. Ultimately, it will also be important to understand~     patients' ability and willingness to use post-discharge VME for educational reinforcement to~     allow for this strategy to transition patients across care settings from hospital to home.~     Through these funded projects, I will acquire critical data I need to develop R-01 studies~     focused on improving self-management for patients with obstructive pulmonary disease across~     care transitions.~      We hypothesize that interactive VME will lead to non-inferior rates of ability to~     demonstrate correct inhaler use compared to rates with TTG among hospitalized patients with~     Asthma or COPD.~      For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler~     technique prior to implementing a larger RCT to test the comparative effectiveness of VME~     versus TTG.~   "
59511|NCT02278224|"~     Group based cognitive behavioural therapy (CBT) is an effective treatment of depression,~     however, one third of patients do not respond satisfactorily (McDermut, Miller, & Brown,~     2001), and relapse rates around 30% have been reported from several studies (Butler,~     Chapman, Forman, & Beck, 2006).~      The present study compares group based CBT with rumination focused CBT for depression with~     respect to outcome and relapse.~      Rumination has been evidenced as a crucial vulnerability to depression (Smith & Alloy,~     2009), predicting the onset, severity and duration of future depression (Nolen-Hoeksema,~     2000). Depressed individuals show a negative bias in the perception of facial emotion, in~     the acute phase as well as in remission (Bouhuys, Geerts, & Gordijn, 1999), and display~     difficulties in disengaging from negative stimuli (Koster, De Raedt, Goeleven, Franck, &~     Crombez, 2005). In addition the present study investigate rumination and perceptual~     attention bias as potential key mechanisms underlying depression.~      128 depressed patients will be recruited and randomised for group based CBT or group based~     rumination focused CBT. Patients are assessed subsequently during treatment and at 6 month~     follow-up regarding depression, rumination, worry, negative perceptual bias, attention~     control. Results are expected at spring 2016.~   "
59512|NCT02278211|"~     This is a multi-centre observational study. It will make use of the positron emission~     tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque~     vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with~     recent myocardial infarctions. The investigators will then perform long-term follow-up of~     these patients to determine the prognostic significance of coronary 18F-NaF uptake~   "
59513|NCT02278198|"~     The purpose of the study is to find out if the small dose of radioiodine, that is used for~     the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer~     cells and make the thyroid cancer treatment less effective.~   "
59514|NCT02278185|"~     This randomized phase II trial compares enzalutamide with standard androgen deprivation~     therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that~     has spread to other places in the body. Metabolic syndrome is defined as changes in~     cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies~     have shown that patients with prostate cancer, who have been treated with standard medical~     therapy that lowers testosterone levels, have an increased risk of these changes. Hormone~     therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by~     the tumor cells instead of lowering testosterone levels. It is not yet known whether~     prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic~     syndrome than patients who receive standard androgen deprivation therapy.~   "
59515|NCT02278172|"~     The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max~     in athletes.~      Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle~     function, lung function, body composition, immune function and the self-reported incidence~     of upper respiratory tract infection.~      This double-blind, randomised, placebo-controlled trial is of parallel design and will aim~     to recruit a total of 50 athletes randomised into either a placebo or treatment group for a~     12-week intervention.~   "
59516|NCT02278159|"~     The purpose of this study is to evaluate which home dialysis modality pattern (home~     hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD)~     allows for the longest home dialysis survival, as defined by the time dialysed in a home~     environment. The investigators hypothesize that patients transferred from one home modality~     to another will have a longer home dialysis survival compared to patients treated only with~     PD or HHD.~   "
59517|NCT02278146|"~     A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System~     for the treatment of urinary incontinence and overactive bladder.~   "
59518|NCT02278133|"~     The purpose of this study is to assess the safety and anti-tumor activity of the triple~     combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or~     RSPO fusions.~      The design of this study is based upon the translational and pre-clinical data that suggest~     that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with~     the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these~     signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor~     activity.~   "
59519|NCT02278120|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial in~     pre-menopausal women with advanced breast cancer.~   "
59520|NCT02278107|"~     A preliminary study to evaluate a new nasal interface and portable ventilator system in~     comparison to standard oxygen therapy in patients with severe chronic lung disease.~   "
59532|NCT02277951|"~     The aim of the study was to compare time and success rates of four intubation devices ( in a~     cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin~     model.~      The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.~   "
59559|NCT02277600|"~     This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy~     male and female subjects. There is no formal hypothesis, however, it is expected that the~     coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase~     the systemic exposure of BMS-626529.~   "
59521|NCT02278094|"~     Background: OSAS is a type of sleep disorder characterized by intermittent, partial or~     complete upper airway (UA) collapse, seriously impacting sleep apnea and respiratory~     insufficiency. The major upper airway dilator muscle (genioglossus) is more active during~     periods of stable breathing compared with periods of cyclical breathing when obstructive~     apneas occurred. UA muscle strength is linearly related to the inspiratory pump muscle~     strength. The ratios of UA muscle strength (tongue protrusion, TP) and inspiratory pump~     muscle strength (PImax) were not different between individuals with and without OSAS.~     However, a highly wakeful ratio of TP force to PImax appears to be associated with a reduced~     propensity to moderate-to-severe OSAS. Up to 95% of OSAS cases are treated with continuous~     positive airway pressure (CPAP), which is the most effective, commonly used, and low-risk~     treatment method. However, patients using CPAP therapy could face ongoing difficulties.~     Aims: To evaluate the effects of home-based exercise for patients with moderate to severe~     OSAS. This study was a randomized clinical trial conducted at three different intervention~     protocols as experimental groups. We will use cluster random sampling assign to each group.~     CPAP treatment group will be the control group. Methods: Subject above 20 years old will be~     diagnosed to moderate and severe OSAS. Subjects will be assign to walking exercise (WE),~     Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment~     groups. We will compare the Polysomnography (PSG) data, Epworth Sleepiness scale (ESS),~     World Health Organization Quality of Life( WHOQOL) questionnaire is a shorter version of the~     original instrument (WHOQOL-BREF), 6-minute walking test (6MWD), rate of perceived exertion~     scale (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strength, anthropometric~     data and daily note at baseline, 3 months (end-of-intervention) and 6 months (post~     intervention follow-up) in patients with moderate to severe OSAS. They will undergo three~     months of the home-based exercises. Patients will be followed up with weekly telephone calls~     and be interviewed monthly. Expected results: By using the WE, TIMT and TMT therapies, the~     airway collapse during sleep will be prevented when the whole body muscle strength,~     inspiratory pump muscle strength and tongue muscle strength are enhanced.~   "
59522|NCT02278081|"~     Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population~     and has be proved to contribute in numerous otolaryngological manifestations. Trails of~     empirical treatment of antireflux medications is often used as a diagnostic test. However,~     the investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is~     considered as first line treatment for nasal obstruction. Hence, the proposed study aims to~     define the relationship between GERD and rhinitis using randomize control trial where one~     group of patients will receive nasonex and placebo, while the other group will receive~     nasonex and antireflux medications.~   "
59523|NCT02278068|"~     The purpose of this research study is to collect information about a new treatment for Type~     2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation~     System which is intended to help regulate blood glucose levels in patients whose (T2DM) is~     not well controlled despite treatment with multiple medications. The medical device delivers~     low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt~     the nerves that lead to the liver. Previous research has shown that disrupting these nerves~     may lead to a lowering of blood sugar levels.~   "
59524|NCT02278055|"~     The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain~     within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's~     level of pain will be followed throughout the study.~   "
59525|NCT02278042|"~     The purpose of this study is to investigate the acute and chronic effects of consumption~     fructose containing sugars and glucose in a real word setting when consumed in a manner and~     amount typical in the American diet.~   "
59526|NCT02278029|"~     This study will synthesize a behavioral profile of impaired driving performance for teenage~     patients with mild traumatic brain injury (mTBI), or concussion, from one week~     post-concussion to six weeks post-concussion. It will also elucidate the relation between~     decreased reaction times exhibited by these patients and their functional response to~     driving hazards. While a few studies have examined driving performance in adult patients~     with mTBI, to the investigators knowledge this will be the first investigation of driving~     performance for teenage patients with mTBI. Therefore, it will provide the foundation for~     the future development of return-to-drive protocols for physicians and clinical~     practitioners. This study will synthesize a behavioral profile of impaired driving~     performance for teenage patients with mild traumatic brain injury (mTBI), or concussion,~     from one week post-concussion to six weeks post-concussion. It will also elucidate the~     relation between decreased reaction times exhibited by these patients and their functional~     response to driving hazards. While a few studies have examined driving performance in adult~     patients with mTBI, to the investigators knowledge this will be the first investigation of~     driving performance for teenage patients with mTBI. Therefore, it will provide the~     foundation for the future development of return-to-drive protocols for physicians and~     clinical practitioners.~   "
59527|NCT02278016|"~     Bacterial meningitis is a potentially life-threatening disease that is associated with~     substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve~     outcome and prevent antibiotic overuse. Here we try to explore new biological markers for~     the diagnosis of the central nervous system infection disease.~   "
59528|NCT02278003|"~     The goal of this study is to extend findings of propofol's effects on memory, as measured in~     volunteer research studies, to a clinical setting.~   "
59529|NCT02277990|"~     Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection~     Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded,~     post-market, interventional clinical study. This study will evaluate the ability of the TYRX~     envelope to reduce major CIED infections through 12-months post-procedure following CIED~     generator replacement, upgrade, revision, or de novo CRT-D implant. Additionally, this large~     device study provides the unique opportunity to prospectively characterize the performance~     of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous~     RV defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for~     those geographies requiring a post-approval study of the TYRX envelope.~   "
59530|NCT02277977|"~     Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic~     shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore~     useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and~     thus multiple organ failure or death. Clinically, the microcirculation can currently be~     indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of~     the present study is to measure the microcirculation in septic shock by means of~     contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to~     24 subjects during and after septic shock. It will be investigated in this study whether the~     microcirculation measurement with ultrasound contrast reflects the severity of the disease.~     As well as to evaluate whether the use of this diagnostic method could lead to better~     treatment of the septic shock.~   "
59533|NCT02277938|"~     Several factors discourage the implementation of cancer screening to the population in~     general, which would result in earlier diagnosis and an expected improved survival.~     Concurrent in vivo and in vitro research has shown that drug acetylation activity is~     increased in cancer. Amantadine may be of value in detecting the presence of cancer.~     Accordingly, this study will examine how Amantadine is eliminated by the body in cancer~     patients. This is an important step in validating a cancer detection method that can be~     implemented economically for screening of large numbers of people.~   "
59534|NCT02277925|"~     Primary Aim:~      The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and~     suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with~     a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent~     (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (2-0~     polydioxanone, PDS) sutures through 1-year.~      Secondary Aims:~        1. To compare the 1-year composite success rate (leading edge of prolapse is at or above~          the hymen and apex has descended less than 1/3 of the vaginal length, no subjective~          feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh~          exposure) of permanent versus delayed absorbable sutures for mesh graft attachment~          during robotic total hysterectomy and sacrocolpopexy.~        2. To compare postoperative symptoms of pelvic floor disorders, including urinary~          incontinence, voiding dysfunction, pelvic organ prolapse, sexual dysfunction and~          quality of life between the 2 groups at 1 year.~        3. To evaluate adverse outcomes in each group, classified according to the Clavien-Dindo~          system.~   "
59535|NCT02277912|"~     The aim of the study is to evaluate the analgesic effects of navigated repetitive~     transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used~     to determine the exact locations for stimulation.~   "
59536|NCT02277899|"~     The purpose of this study is to determine communication content and strategies in primary~     care that predict improvement in weight status among overweight school-age children.~   "
59537|NCT02277886|"~     Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms,~     resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication~     indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label,~     randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed~     time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive~     GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include~     percentage of patients with relief or complete resolution of nighttime heartburn (or~     regurgitation), percentage of patients with relief or complete resolution of GERD-related~     sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation)~     over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI)~     questionnaire total score, and change of the percentage of patients with relief of nighttime~     heartburn (or regurgitation) at post-treatment visit as compared to final visit in test~     group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study~     hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in~     relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.~   "
59538|NCT02277873|"~     The purpose of this study is to establish the relationship between moon and births through~     two analytic models.~   "
59539|NCT02277860|"~     Physical activity and exercise have become an accepted and valued component of cystic~     fibrosis care. Regular physical activity and exercise can slow the rate of decline of~     pulmonary function, improve physical fitness, and enhance quality of life. However,~     motivating people to be more active is challenging. Supervised, facility-based exercise~     programs are expensive and labor intensive (since groups of patients with CF cannot exercise~     together in the same physical location). Home-based exercise using an interactive exergame~     device may be an effective way to improve adherence to an exercise program for patients with~     CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week,~     home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary~     endpoint is nasal potential difference, an indicator of how well sodium and chloride flow~     across the mucous membranes in the nose. Other outcomes include patient-reported quality of~     life and habitual physical activity level. Following baseline assessments participants will~     be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes~     per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus~     exergaming device. Participants will receive at least monthly follow-up phone calls to~     provide additional exercise counseling and motivation. After 12 weeks, they will continue~     with the exergame intervention for another 12 weeks, but without external supervision.~   "
59540|NCT02277847|"~     Study Design: Treatment, Randomized, Open Label, Parallel Assignment This study is an open~     randomized and controlled trial aiming at assessing the efficacy and safety of Idarubicin~     (IDA) at different doses of 8mg/m2 and 10mg/m2 combined with cytarabine as induction therapy~     for newly diagnosed Acute Myeloid Leukaemia (AML). All the recruited patients are allocated~     to group A ( 8mg/m2 group) or group B ( 10mg/m2) in random. It is advised that induction~     therapy should begain not late than 3 days after randomization. The regimens in detail can~     be refered in the therapy protocol.~   "
59541|NCT02277834|"~     Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are~     collecting and studying the fluid produced by the pancreas as a way to detect pancreatic~     cancer at an earlier stage.~   "
59542|NCT02277821|"~     The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to~     the hypertension consultations for essential hypertension treated but not stabilized. The~     effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral~     cutaneous microcirculation and on the central arterial pressure.~   "
59543|NCT02277808|"~     The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®,~     disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have~     comparable properties and better availability to the hospital. Several studies remark that~     all nebulizers with comparable properties could be used for the nebulization.The aim of our~     work will be to evaluate and compare the pulmonary deposition between the reference~     nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb~     ®. We will measure and compare these data's for each of the nebulizers via nebulization~     Amikacine and urinary dosage.~   "
59544|NCT02277795|"~     Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention~     strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces~     men's risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male~     circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and~     other sexually transmitted infections, and is less expensive and safer. To provide the~     evidence-based guidance for implementation of EIMC services, the investigators propose an~     implementation study to address several salient operations-research questions. Members of~     the research team have conducted a pilot study of the promising, but relatively new AccuCirc~     device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the~     potential to simplify supply chain management in addition to eliminating the rare but~     serious potential complications associated with other EIMC devices. The investigators~     propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device.~     Furthermore, it is imperative to identify, understand and overcome barriers to the adoption~     and integration of EIMC from the perspective of providers, about which virtually nothing is~     known. The investigators will explore, through qualitative methods, the perspective of~     providers with regard to offering and providing EIMC services. Equally important is having a~     thorough understanding of decision-making among parents with regard to opting for EIMC. The~     research team proposes to study this through collection of qualitative data among fathers~     and mothers. Lastly, the investigators will gather observational survey data from mothers in~     the catchment area and data from mothers who opted for EIMC will be compared with those from~     mothers who did not opt for EIMC to identify factors associated with uptake, including if,~     when, where and by whom EIMC services were offered. Among providers and parents the~     researchers will specifically explore what role, if any, the EIMC device plays in~     decision-making. The findings from this study will provide evidence necessary to refine~     implementation strategies for EIMC into public health and clinical practice settings and to~     assist the Kenyan Ministry of Health, other African governments and PEPFAR in the scale-up~     of EIMC service delivery for long-term HIV prevention.~   "
59545|NCT02277782|"~     The objective of this study is to evaluate the effect of intrathecal hydromorphone on the~     duration of labor analgesia and the incidence of epidural-associated temperature increase in~     laboring parturients. We hypothesize that intrathecal administration of longer-acting~     hydromorphone will:~        1. Prolong the duration and improve the quality of analgesia in labor, and~        2. Decrease the incidence of epidural-associated temperature increase in labor.~   "
59546|NCT02277769|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the~     efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic~     dermatitis (AD).~   "
59547|NCT02277756|"~     Pain insensibility is often described in people with autism. The aim of this study is to~     test the pain perception in adults with autistic spectrum disorder without intellectual~     disability. An experimental model of pain is used to measure endogenous modulation systems.~     Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test~     excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system~     (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint~     natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation~     assessed by an inspired behavior scale.~   "
59548|NCT02277743|"~     This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the~     efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic~     dermatitis (AD).~   "
59549|NCT02277730|"~     Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal~     and fetal adverse effects. The investigators developed a double-vasopressor automated system~     incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step~     algorithm.~   "
59550|NCT02277717|"~     The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at~     different dose levels in patients with cancer, to understand how SYD985 is handled by the~     body and to evaluate the effect of SYD985 on the cancer.~   "
59551|NCT02277704|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose,~     parallel-group study that will investigate the efficacy and safety of two doses of TNX-102~     SL —a sublingual formulation of cyclobenzaprine. Following successful screening and~     randomization, eligible subjects will return regularly to the study clinic for weekly or~     biweekly visits for assessments of efficacy and safety.~   "
59552|NCT02277691|"~     Primary objective of this study is to evaluate the safety of long-term administration of~     TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in patients with essential~     hypertension.~   "
59553|NCT02277678|"~     The primary objectives of this study are to compare the efficacy of pain relief between~     epidural oxycodone and epidural morphine for postoperative analgesia after elective~     caesarean section and to compare the incidence and severity of pruritus. Secondary~     objectives are to compare other side effects of epidural administered oxycodone and morphine~     (nausea and vomiting, sedation, respiratory depression) and to investigate the safety and~     efficacy of epidural oxycodone and epidural morphine after use for postoperative analgesia~     in caesarean sections.~   "
59554|NCT02277665|"~     Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly~     smoke tobacco. Combining tobacco with cannabis has become a common method of smoking~     cannabis. Similarities of use, and using together, can make quitting difficult. Stopping~     tobacco simultaneously with cannabis may be beneficial. Little scientific information~     currently addresses how to best target tobacco smoking during treatment for CUDs. Our~     long-term goal is to develop an effective protocol for intervening in tobacco smoking~     without changing cannabis outcomes.~      This protocol reflects the planned Stage 1, proof-of-concept study that will compare a~     combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert~     that the intervention (1) will be accepted by the majority of eligible participants (2) will~     result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not~     adversely affect cannabis outcomes. Last, the project will evaluate the potential of~     specific moderators of outcomes to predict outcomes and inform subsequent treatment~     development efforts. If the hypotheses were confirmed, dissemination of this protocol would~     reduce adverse psychosocial and health consequences of tobacco or cannabis dependence.~     Findings will inform future development of prevention and intervention strategies.~   "
59555|NCT02277652|"~     The purpose of this study was to compare the four different intubation devices in 6~     different scenarios.~   "
59556|NCT02277639|"~     This is a Phase II trial to determine the ability of a reduced intensity conditioning~     regimen to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell~     grafts from mismatched donors. There are two conditioning regimens depending upon patient~     diagnosis and age.~   "
59557|NCT02277626|"~     It is the goal of the proposed study to compare the efficacy, as assessed primarily by~     sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for~     airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable~     lung health and perform AC at home as part of their routine therapeutic regimen.~   "
59560|NCT02277587|"~     This is a randomized, controlled, open, three-armed, multi-centre study designed to compare~     the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid~     therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile,~     cardiovascular system, bone mass and quality of life in patients affected by primary or~     secondary adrenal insufficiency.~   "
59561|NCT02277574|"~     This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation,~     multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.~   "
59562|NCT02277561|"~     This pilot clinical trial studies how well voxel based diffusion tensor imaging in~     predicting response in patients with brain metastases undergoing whole-brain radiation~     therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may~     allow doctors to measure response to whole brain radiation therapy or stereotactic~     radiosurgery earlier than is possible with a standard magnetic resonance imaging. The~     earlier ability to measure response may allow for consideration of alternative therapies at~     an earlier stage.~   "
59563|NCT02277548|"~     To assess the efficacy of pregabalin in the management of mucositis pain in patients~     receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among~     those being treated for oropharyngeal cancer with definitive chemotherapy and radiation~     therapy (photons) to the head and neck in the Department of Radiation Oncology at the~     University of Pennsylvania.~   "
59564|NCT02277535|"~     This is a quality improvement research project evaluating if a targeted feedback email to~     clinicians impacts their nutrition delivery in the ICU.~   "
59565|NCT02277522|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen~     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as~     RNA CART19) in Hodgkin Lymphoma (HL) patients.~   "
59566|NCT02277509|"~     This study is being conducted in two phases. The first phase was a pilot implementation of~     the study protocol, which provided preliminary data from seeking funding for a larger scale~     trial. The study focused on testing the effects of a Diabetes Prevention Program (DPP) that~     has been adapted culturally and linguistically to address diabetes prevention among Chinese~     immigrants. Study implementation involves a variety capacity building community partnership~     initiatives. Partnering organizations within New York City (NYC) have included the Chinese~     Community Partnership for Health (CCPH) of New York Presbyterian Hospital of Lower Manhattan~     Hospital, the Chinese American Independent Practice Association (CAIPA), the Diabetes~     Research and Training Center of Albert Einstein College of Medicine (Einstein), and the City~     University of New York (CUNY) School of Public Health. More recently, our collaboration has~     expanded the potential for wider dissemination in collaboration with the Pace University~     Confucius Center of the Confucius Institute. By supporting Chinese language and cultural~     programs, the Confucius Institute facilitates communication with the 2 billion native~     Chinese speakers as migration and trade increase interactions globally.~   "
59567|NCT02277496|"~     The project, which being conducted as stepped wedge cluster randomized trial, is designed to~     evaluate a participatory implementation model in NYC HealthCorps (HC) high schools and to~     assess outcomes within and across school settings . The behavioral objectives from the 2010~     Dietary Guidelines to address obesity in youth include: 1) decreasing sugary beverage~     intake; 2) increasing frequency of breakfast; 3) increasing vegetable and fruit intake to 2½~     cups per day;4) decreasing frequency of fast food meals;5) becoming physically active (goal~     of 1 hour per day); and 6) reducing sedentary behavior time (<2 hour day). The study is~     employing system dynamics modeling (SDM) to assess wellness programming options and to~     evaluate the program implementation within the context of diverse school ecologies. The~     RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance)~     is used to guide SDM development and validation.~      The Specific Aims are:~        1. To refine the participatory school wellness program model and toolkits. The study team~          will add simulation exercises to engage stakeholders and refine toolkit strategies that~          address institutional/community level program implementation barriers and individual~          level barriers to achieving healthy lifestyle recommendations.~        2. To assess the impact of participatory implementation programming in participating~          schools. Primary hypothesis: Students will achieve key health behaviors after their New~          York City (NYC) HealthCorps school is randomized to participatory implementation~          compared to students in the wait-listed HealthCorps control schools; Secondary~          hypothesis: Improvements in the key behaviors will be greater in students whose BMI~          z-scores decrease compare to those whose BMI z-scores did not decrease.~        3. To evaluate implementation with system dynamics modeling to facilitate dissemination.~          The simulation analysis will apply the RE-AIM framework to address: Reach~          (participation rates), effectiveness (outcomes), adoption (acceptability),~          implementation (intervention fidelity), and maintenance (sustainability of lifestyle~          changes by students and programs by schools), in order to facilitate refining the~          toolkits and training program for dissemination to other school setting and diverse~          educational venues.~   "
59568|NCT02277483|"~     Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared~     to standard drug treatment in patients aged over 60 years suffering from house dust mite~     (HDM) induced allergic rhino-conjunctivitis with/without asthma.~   "
59569|NCT02277470|"~     The purpose of this study is to gain insights in the pharmacokinetics of golimumab in~     moderate to severe Ulcerative Colitis after subcutaneous administration, during induction~     and maintenance treatment the investigators will collect blood and stool samples at~     different time points.~   "
59570|NCT02277457|"~     Hypotheses:~      Short-term - Targeted therapy with erlotinib or crizotinib plus PART (Personalized Adaptive~     Radiation Therapy) will be safe and will yield favorable outcomes in patients with stage~     III, EGFR (Epidermal Growth Factor Receptor) + or ALK (Anaplastic Lymphoma Kinase) + NSCLC~     (Non-Small Cell Lung Cancer).~      Long-term - In patients with stage III NSCLC harboring driver mutations, treatment with~     relevant targeted agents plus PART will improve both local-regional and systemic tumor~     control resulting in improved survival relative to standard chemoradiotherapy.~   "
59571|NCT02277444|"~     The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) of golimumab administered intravenously~     (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an~     onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested~     by >= 5 joints with active arthritis and C-reactive protein (CRP) of >=0.1~     milligram/deciliter (mg/dL) despite methotrexate (MTX) therapy for >= 2 months.~   "
59572|NCT02277431|"~     Participants experiencing recurrent gastrointestinal symptoms in this double-blind,~     randomized, controlled trial will receive either a commercially-available probiotic dietary~     supplement or placebo. The investigators hypothesize that participants in the probiotic~     dietary supplement group will experience greater improvement in their gastrointestinal~     symptoms than participants in the placebo group.~   "
59573|NCT02277418|"~     The purpose of this study was to compare the Venner a.p. advance video laryngoscope to~     Miller laryngoscope during resuscitation with and without chest compressions.~   "
59575|NCT02277392|"~     This is a phase-I, dose escalation study to assess the safety and biological activity of~     cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of~     vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and~     recombinant human interleukin-18 (SB-485232, IL-18) treatment in adult patients with~     recurrent, Stage III or IV ovarian cancer, fallopian tube or primary peritoneal cancer who~     previously underwent induction vaccination with whole tumor vaccine~   "
59576|NCT02277379|"~     Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent~     problem. Antiplatelet therapy (APT) is an integral component of perioperative management in~     patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early~     postoperative bleeding extent and transfusion requirements remains difficult to predict.~      In addition to, resistance to antiplatelet drugs as well as perioperative increase in~     platelet reactivity following CPB has been reported but this phenomenon has to be~     comprehensively investigated.~      The best point-of-care platelet function test to predict bleeding complications/transfusion~     requirements remains unclear. In addition to, the best test platelet function test to~     monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains~     elusive.~      The aim of this study is:~        1. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM~          Platelet) in regard to prediction of bleeding complications/trasfusion requirements.~        2. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM~          Platelet) in regard to detection of high on-treatment platelet reactivity both pre-~          and postoperatively.~   "
59577|NCT02277366|"~     The purpose of this study is to determine the diagnostic yield of early lung cancer in high~     risk population, who smokes or has other risk factors, by different bronchoscopy,.~     Furthermore, another purpose is to determine whether the different bronchoscopy are~     significant different in diagnosing early lung cancer.~   "
59578|NCT02277353|"~     NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices~     derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the~     previous studies. However, its usefulness in prone positioning has not been investigated.~     Thus, the aim of this prospective observational study is to evaluate the usefulness of~     stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone~     patients undergoing spine surgery.~   "
59579|NCT02277340|"~     This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic~     cleaning and fulguration of pilonidal sinus inner surfaca followed by application of~     crystallized phenol into the sinus.~   "
59580|NCT02277327|"~     The investigators hypothesize that an intervention, within an established patient-centered~     medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital~     utilization among medically complex children.~   "
59581|NCT02277314|"~     The overall objective is to determine the visual outcomes and cost to perform Manual Small~     Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the~     United States. The primary outcome measure will be the percentage of the study group~     achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to~     historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed~     in academic centers. A secondary outcome will be to determine the actual institutional cost~     of providing MSICS in the setting of an academic medical center. The hypothesis is that~     MSICS is appropriate for a teaching environment (as evidenced by a comparable rate of 20/40~     acuity or better at 90 days post op, as compared to PCS), and can be provided at a cost that~     makes visual rehabilitation affordable to the uninsured and underinsured.~   "
59582|NCT02277301|"~     This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint~     (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted~     in three areas of Northern Ireland: Lisburn, North Down & Ards, and Downpatrick. At least 50~     women with infants under 13 months old will be recruited during August/September 2014.~   "
59583|NCT02277288|"~     The purpose of this randomized control trial study is to determine if intraoperative bladder~     instillation of fluid decreases the time to discharge after having an outpatient~     mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital~     stay. Charges will be broken down between recovery room charges and discharge area, as~     recovery room charges are significantly higher. The investigators suspect that a shorter~     time in the recovery room will translate into fewer charges.~   "
59584|NCT02277275|"~     High-protein diets better preserve lean mass than conventional low-fat diets. However, they~     are costly and have potential health risks. Preserving lean mass is important for sustaining~     high resting energy expenditure, leading to greater initial weight loss, better weight~     maintenance and improving blood sugar levels. Branched-chain amino acids (BCAA) supplements~     are known to preserve lean mass but their effects during weight loss have not been examined.~     Investigators want to investigate if a BCAA-supplemented diet is more effective than a~     standard hypocaloric diet in terms of the aforementioned benefits, and yet has less~     detrimental effects than a high-protein diet for weight loss. Using a 16-week weight loss~     and 8-week weight maintenance intervention, overweight and obese men and women will be~     randomized to either a hypocaloric diet with BCAA or placebo supplements or a high-protein~     diet with placebo supplements. Participants' compliance to the diet versus supplements will~     be compared. Body composition, resting and diet-induced energy expenditure, insulin~     sensitivity will be measured and blood samples taken before and after weight loss. These~     findings will inform on the benefits of BCAA-supplementation during energy restriction and~     may offer an alternative cost-effective strategy for weight loss and maintenance, without~     the adverse health effects of a high-protein load.~   "
59585|NCT02277262|"~     To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted~     preperitoneally as a prophylactic procedure against incisional hernia in patients operated~     in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of~     the study is to reduce the incidence of incisional hernia from 50% to 20%.~   "
59697|NCT02275806|"~     This is a prospective, single institution phase II study, whose primary objective is to~     estimate the median and three year survival rate of non-small lung cancer patients with~     Stage IIIA and IIIB intra-thoracic disease which is referred to as locally advanced~     non-small cell lung cancer (NSCLC).~   "
59698|NCT02275793|"~     Peripheral blood and blood following a pulmonary wedge pressure will be obtained from~     patients undergoing right heart catheterizations.~   "
59586|NCT02277249|"~     Current practice for the provision of late second trimester abortion (dilation and~     evacuation, or D&E) often involves the administration of digoxin into the fetal compartment~     to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally~     or transvaginally into the fetal compartment. Both modes of administration have been shown~     in prospective studies to be highly effective and safe. Both modes of administration are~     considered standard of care. This pilot study will directly compare transabdominal and~     transvaginal digoxin with respect to patient preference (i.e, patient pain score describing~     discomfort with injection).~   "
59587|NCT02277236|"~     This pilot study will aid the development of a sonographic screening method used to obtain~     proxy measures of LBM and estimates of muscle composition that relate to Intramuscular~     adipose tissue (IMAT), lipid metabolism, and insulin resistance. Typically, age-related~     muscle loss is not assessed in older adults until they began to show signs of trouble~     managing their own lives independently. In addition to the loss of independence that is~     typically seen with diminished muscle mass and function (sarcopenia), age-related changes in~     lean body mass can have negative effects on insulin sensitivity. The investigators central~     hypothesis is that the muscle characteristics derived from ultrasound (US) will be~     significantly associated with estimates of dual energy X-ray absorptiometry (DXA) LBM, CT~     scan measures of IMAT, estimates of insulin sensitivity, and serum levels of inflammatory~     cytokines and macrophages.~   "
59588|NCT02277223|"~     Background: Curcumin in an active phytochemical substance, used as part of the human diet,~     that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple~     experimental models of colitis including a positive effect on maintenance of remission in~     adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as~     complementary medication in induction and maintenance therapy in pediatric patients with~     mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled~     study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18~     years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or~     corticosteroids induction treatment. Main outcome measures: Disease activity defined by the~     Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary~     outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin~     and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version~     21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate~     associations between primary outcomes and categorical variables. Associations of continues~     variables with primary outcome measures will be examined using ANOVA with repeated measures.~     P-values <0.05 will be considered significant.~   "
59589|NCT02277210|"~     Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF~     treatment. Follicular flushing has been advocated. However, subsequent data from randomized~     trials failed to demonstrate any benefits with routine follicular flushing in normally~     responding patients. Instead, it has been shown to prolong the operating time, increase the~     procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform~     routine follicular flushing in normally responding patients.~      The potential role of follicular flushing in patients with a limited number of developing~     follicles is conflicting based on the recently published randomized trials. The aim of the~     present study is to determine the effect of follicular flushing on the ongoing pregnancy~     rate in patients who developed four or fewer follicles of 14mm following standard ovarian~     stimulation for IVF.~   "
59590|NCT02277197|"~     The epidermal growth factor receptor (EGFR) is both oncogene and prognostic biomarker in~     head and neck squamous cell carcinoma (HNSCC). EGFR's functional importance in HNSCC~     resulted in development of the first molecularly targeted strategy, the anti-EGFR monoclonal~     antibody cetuximab. Given the lack of therapeutic options for patients with~     recurrent/metastatic HNSCC after failure of cetuximab, there is strong scientific interest~     in understanding resistance in order to identify new therapies for this population. A~     possible resistance mechanism to anti-EGFR therapy in HNSCC is primary or compensatory~     activation of alternate growth factor receptors including c-Met. The MET oncogene encodes~     c-Met, an RTK bound exclusively by the ligand, hepatocyte growth factor (HGF). The HGF/c-Met~     signaling pathway converges with the EGFR network at both the PI3K/Akt and MAPK nodes.~     Laboratory data suggest the ability for reciprocal compensation between EGFR and c-Met. We~     hypothesize that HGF/c-Met pathway inhibition may overcome resistance to cetuximab in~     patients with HNSCC, such as those with clinical cetuximab resistance.~      Ficlatuzumab (AV-299) is a humanized HGF-inhibitory immunoglobulin G1 (IgG1) monoclonal~     antibody. The primary objective of this phase 1b study is to find the recommended phase II~     dose (RP2D) of the combination of ficlatuzumab and cetuximab in patients with~     recurrent/metastaticHNSCC. The dose-finding study design will follow a Narayana k-in-a-row~     design with k set to 2 to target a 33% rate of dose-limiting toxicity (DLT). In the~     dose-finding phase, a total of 8 patients will be treated if no DLTs are observed or 14~     patients if at least one DLT occurs. An expansion cohort will then proceed at RP2D until 12~     patients have been treated at that dose level with the combination of ficlatuzumab and~     cetuximab. We will evaluate biomarkers of HGF/cMet pathway activation in baseline tissue,~     plasma and immune cells for a preliminary relationship with clinical activity.~   "
59591|NCT02277184|"~     Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the upper~     aerodigestive tract, and is the sixth leading incident cancer worldwide. Despite advances in~     multimodality therapy, 5-year overall survival (OS) is 40-60%, and has increased only~     incrementally in the past two decades. The current standard of care for primary nonsurgical~     management of locally advanced HNSCC is concurrent cisplatin-radiotheray, which~     significantly improved OS, progression-free survival, and locoregional control compared with~     radiotherapy alone in the landmark Intergroup trial 0126.~      The MET proto-oncogene encodes c-Met, a heterodimeric growth factor receptor bound~     exclusively by its ligand, hepatocyte growth factor (HGF). In the laboratory, activation of~     the HGF/c-Met pathway is associated with resistance to cisplatin and radiotherapy in HNSCC.~     We hypothesize that the addition of an HGF/c-Met pathway inhibitor to cisplatin-radiotherapy~     may improve outcomes in HNSCC. Ficlatuzumab (AV-299) is a humanized HGF-inhibitory IgG1~     monoclonal antibody.~      The primary objective of this study is to establish the recommended phase II dose (RP2D) of~     the combination of ficlatuzumab, cisplatin and intensity-modulated radiotherapy (IMRT), in~     patients with locally advanced HNSCC. The dose-finding study design will follow a Narayana~     k-in-a-row design with k set to 3 to target a 33% DLT rate. In the dose-finding phase, a~     total of either 10 or 14 patients will be treated. If no DLTs are observed among 10~     patients, the highest dose tier will be declared the RP2D. Otherwise the RP2D will be~     estimated from DLTs across all dose levels by isotonic regression. The secondary objective~     is to estimate biomarker association with preliminary clinical response. We will evaluate~     biomarkers of HGF/cMet pathway activation in tumor tissue, plasma, and immune cells.~   "
59617|NCT02276846|"~     The aim of the study is to use optical coherence tomography (OCT) to investigate the~     efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting~     stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0~     mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either~     branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any~     Medina classification type in the native coronary artery as reflected by procedural success~     and to evaluate the preservation of vessel patency.~   "
59592|NCT02277171|"~     According to the World Health Organization, hundreds of millions of patients are affected by~     health-care associated infections worldwide each year, resulting in prolonged hospital~     stays, long-term disabilities, deaths, and financial losses for health systems. The most~     common hospital-acquired infection is Urinary Tract Infection (UTI), accounting for almost~     40% of all nosocomial infections. Most hospital-acquired UTIs are associated with~     catheterization. In fact, urinary catheter-related bacteriuria is the most common health~     care associated infection worldwide. Catheter-associated UTI (CAUTI) develops following~     adhesion of planktonic bacteria to the surface of the catheter and colonization, creating a~     persistent environment called a biofilm. The nature of biofilm structure together with the~     physiological attributes of biofilm organisms confers an inherent resistance to various~     antimicrobial agents such as antibiotics, disinfectants or germicides, augmenting the~     potential of these pathogens to cause infections in catheterized patients.~      Nitric oxide (NO) is a naturally-produced gas molecule with broad-spectrum antimicrobial~     activity. NO is used in the clinics to treat pulmonary hypertension in neonates and adults.~     Studies have shown that low-dose NO is associated with prevention of biofilm formation,~     biofilm dispersal and elimination of bacteria. It is suggested that NO prevents bacteria~     attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving~     reduction and modification of proteins that mediate cell-substrate and cell-cell~     interactions.~      The investigators team, using a proprietary technology impregnate urinary catheters with NO~     (i.e. NO-impregnated catheters). These catheters release low concentration of NO following~     exposure to urine over a 14-day period. In vitro studies showed that NO-impregnated~     catheters prevent bacterial colonization and biofilm formation of Escherichia coli on~     exterior and luminal surfaces of the catheters. In addition, NO released from these~     catheters is able to eradicate up to 4log colony forming unit/ml of bacteria within the~     surrounding media. Moreover, NO-impregnated catheters exhibit superior performance compared~     to silver-coated catheters, and similar anti-infective properties compared to~     antibiotic-coated catheters.~      Primary objectives: To assess the safety and tolerability of NO-impregnated catheters in~     patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14~     days.~   "
59593|NCT02277158|"~     The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus~     radiotherapy for patients with rectal cancer~   "
59594|NCT02277145|"~     Radiation therapy is one of the main means for treating malignant tumor, during which~     radioactive lung injury is inevitable. Currently there is nearly no effective clinical~     treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an~     open, single-center, non-randomized phase I clinical trial. During the treatment, the local~     lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells~     (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month~     observation, the investigators will initially evaluate the safety and effectiveness of the~     treatment by measuring two key indicators-the CT density histogram and the patients'~     self-evaluation, and one secondary indicator—the changes of TGF-β1 contents, both before and~     after the treatment. Meanwhile, the investigators will make a preliminary discuss about the~     possible immunomodulatory effects of the umbilical cord MSCs.~   "
59595|NCT02277132|"~     Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency~     is associated with a high risk of perinatal morbidity with long-lasting sequelae and~     mortality. Placental insufficiency is the result of abnormal formation and function of the~     placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental)~     arteries. There is currently no therapy available with demonstrated effectiveness. Evidence~     suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful~     outcomes.~      Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy~     perinatal survival.~      Study design: Multicenter nationwide randomized placebo-controlled clinical trial.~      Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal~     growth restriction of likely placental origin, and with estimated significant likelihood of~     perinatal death.~      Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study~     parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal~     morbidity at term age.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Taking tablets three times daily. No additional ultrasounds, other than~     standard clinical protocol, one extra blood sample at inclusion. No risks anticipated,~     unexpected medication-associated risks can't be excluded on beforehand.~   "
59596|NCT02277119|"~     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber~     Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices~   "
59597|NCT02277106|"~     Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,~     tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with~     essential tremor in the upper limb.~      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and~     effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed~     Stage 1 will be invited to participate in Stage 2.~   "
59598|NCT02277093|"~     The investigators propose to assess the efficacy, progression-free survival, and adverse~     events of pacritinib in patients with refractory colorectal cancer.~   "
59599|NCT02277080|"~     The primary aim is to investigate the dose and time dependent effects of different opioids~     on the immune and endocrine systems.~      The secondary aim is to investigate whether associations between the function of the immune~     and endocrine systems and opioid use influence cognitive function, pain and quality of life.~   "
59600|NCT02277067|"~     We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in~     high risk patients after C.S.~   "
59601|NCT02277054|"~     In this study the safety and effectiveness of biosynthetic cornea, comprising~     interpenetrating networks of recombinant human collagen and phosphorylcholine, will be~     tested in patients with severe corneal pathology (corneal ulcers or corneal opacification~     from corneal injury, burn or infection) - diseases, where human donor cornea transplantation~     (the only widely accepted treatment) carries a high risk of rejection.~   "
59602|NCT02277041|"~     We will compare efficacy and safety of Carbetocin with Misoprostol in prevention of~     postpartum hemorrhage in Placenta previa women after C.S.~   "
59603|NCT02277028|"~     This study will compare bilateral priming followed by task specific training to health care~     education followed by the same task specific training protocol. The intention is to~     understand the effects of priming on upper limb training post-stroke.~   "
59604|NCT02277015|"~     The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines~     suggest that intubators should be able to secure the airway without interrupting chest~     compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope~     (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for~     endotracheal intubation (ETI) during pediatric resuscitation with and without chest~     compressions.~   "
59634|NCT02276625|"~     To determine optimum dose level for a single visit multidose intradermal injection of rabies~     vaccine with the aim to induce immunological memory in all subjects.~   "
59605|NCT02277002|"~     Traffic related air pollution is a well-recognised and much studied contributor to smog and~     is linked to a number of adverse health outcomes. Although traffic pollutants can travel~     long distances, exposure to the highest levels of the raw emissions can occur closest to the~     source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up~     to half of commuters' daily exposure to certain air pollutants. Most new cars now have or~     allow for a cabin air filter, but it is not known how well cabin air filtration can reduce~     exposure to traffic-related air pollution.~      This intervention study will measure commuters' exposure to air pollutants in rush hour~     traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and~     short term cardiopulmonary health indicators such as blood pressure, heart rate variability~     and respiratory inflammation. It will also look at effects on cognition (mental processing~     and judgement) in this real world environment where any deficit could be important to~     safety. In addition, the study will examine whether cabin air filtration can reduce the~     exposure to traffic related air pollutants and result in improvements in short term~     cardiopulmonary and cognitive function. This research will contribute to our understanding~     of how this environment contributes to Canadians' overall air pollution exposure as well as~     the potential health impacts. It will also test a potentially valuable and economical means~     of reducing exposure to traffic related air pollution in a commuting environment. The study~     may also guide the future implementation of the use of cabin filters as an exposure~     reduction intervention.~      Overall Project Objectives:~      Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does~     commuter exposure to air pollution affect short term stress, and cardiopulmonary and~     cognitive function? Can cabin air filtration mitigate the health effects of commuters'~     exposure to air pollution?~   "
59606|NCT02276989|"~     In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic~     pain and on buprenorphine therapy, this study will investigate the utility and feasibility~     of two novel tracer compounds, and in combination with a standard marker (riboflavin), to~     monitor adherence to study drug prescription in the parent clinical trial.~   "
59607|NCT02276976|"~     The purpose of this study is:1)to observe topological organization in brain structural and~     functional networks in cerebral white matter lesion patients and to evaluate the association~     between impairment of cognitive function and cerebral structural and functional networks in~     those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of~     cerebral white matter lesions~   "
59608|NCT02276963|"~     Ublituximab (also known as LFB-R603) is a monoclonal antibody that specifically binds to the~     trans-membrane antigen CD20. The binding induces immune response that causes lysis of B~     cells.~      The rationale for using ublituximab in neuromyelitis optica (NMO) and neuromyelitis optica~     spectrum disorder (NMOSD) is based on the known roles of B cells, antibody production and~     plasma cells in the pathophysiology of NMO. NMO is characterized by the presence of an~     anti-AQP4 antibody, which can only be produced by differentiation of B cells to plasma~     cells. Because these anti-AQP4 antibodies may be pathogenic, B cells recognizing AQP4 may be~     directly involved in the disease process as well. B cells also play a role as potent antigen~     presenting cells in NMO. The strongest evidence of the importance of B cells in NMO comes~     from studies of B cell depletion, most commonly with anti-CD20 monoclonal antibody,~     rituximab (Rituxan®).~      Rituximab has been shown in five retrospective and two prospective studies to be effective~     in reducing NMO relapses up to 90% and achieving remission in up to 80% of patients solely~     by its action on CD20+ B cells, despite no change in plasma cell population and anti-AQP4~     antibody titers. These human trials strongly suggest a critical role for B cells in the~     pathophysiology of human disease. While typically used in the prevention of disease, B-cell~     depletion may be beneficial in the treatment of an acute relapse as well. Emerging evidence~     indicates that peripheral B cells are activated during a relapse and plasmablast production~     of anti-AQP4 antibodies spikes. B cells are also found within acute lesions of the spinal~     cord and optic nerve suggesting roles both in the blood and in the central nervous system~     during a relapse.~   "
59609|NCT02276950|"~     The overall project aim is to study risk and outcomes following cardiac surgery by~     cross-linking high-quality national Swedish health-data registers for population-based~     investigations of individual level clinically relevant patient data.~   "
59610|NCT02276937|"~     DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on~     recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human~     fibroblast growth factor-2 (FGF-2) gene. The previous Phase I/IIa study demonstrated no~     serious adverse event related to the administration, and suggested possible improvement of~     local blood flow and walking performance of PAD patients.~      The primary objective of the current Phase IIb study is to investigate the clinical efficacy~     of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC. We also aim to examine~     the dose-response relationship using the rate of improvement in walking function as an~     indicator.~   "
59611|NCT02276924|"~     Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year.~     The standard treatment for these tumors is the ablation of the kidney, ureter and a part of~     the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment~     techniques through natural routes opens the possibility to use conservative treatments. The~     investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will~     allow the discrimination between normal and pathologic urothelium by microscopic analysis.~     This will prevent the systematic use of biopsies which are often difficult and iatrogenic.~   "
59612|NCT02276911|"~     A prospective, randomized, placebo controlled, double-blinded study at a single institution.~   "
59613|NCT02276898|"~     The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more~     sensitive than FEV1. It can be used to measure lung function in children younger than 6~     years of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic~     Fibrosis (CF) population. As such, determining if it can be used as a short term~     pharmacodynamic biomarker is paramount.~   "
59614|NCT02276885|"~     The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5~     days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five~     consecutive days~   "
59615|NCT02276872|"~     This is a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral~     treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who are, (1)~     transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin~     therapy; or (3) not currently receiving prostacyclin therapy.~   "
59616|NCT02276859|"~     Patients receive a standardized high-protein test meal at breakfast time. Insulin is given~     as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The~     3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG)~     (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking~     part under in-patient clinical conditions.~   "
59635|NCT02276612|"~     This study will assess the safety, efficacy and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected~     virologically suppressed adolescents 12 to < 18 years of age.~   "
59618|NCT02276833|"~     Autologous adipose-derived stromal vascular fraction (SVF) was used to treat 10~     osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a~     feasibility and safety study. The adipose-derived SVF was obtained through disaggregation of~     lipoaspirate and resuspension of the SVF in 3 ml of Lactated Ringer's Solution, with a mean~     of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell~     suspension was injected into the intra-articular space using ultrasound guidance. At 12~     weeks post-op all 10 knees showed decreased pain and increased mobility, both statistically~     significant (α = .01). Nine of ten knees reported either maximum possible or very~     significant decrease in pain. No infections, acute pain flares, or other adverse events were~     reported. Patient ages ranged from 52 - 69 years with a mean of 59 years.~   "
59619|NCT02276820|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which~     can cause serious life-threatening infections in patients who have weak immune systems. It~     usually affects the lungs and can cause a very serious pneumonia, but it can also affect the~     gut, the liver, the pancreas and the eyes.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     adenovirus infections that occur after a transplant. Investigators have observed in other~     studies that treatment with specially trained T cells has been successful when the cells are~     made from the transplant donor. However as it takes 1-2 months to make the cells, that~     approach is not practical when a patient already has an infection.~      Investigators have now generated AdV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target AdV.~      In this study, investigators want to find out if the banked AdV-specific T cells derived~     from healthy donors are safe and can help to treat adenoviral infection.~      The AdV-specific T cells (Viralym-A) are an investigational product not approved by the Food~     and Drug Administration (FDA).~   "
59620|NCT02276807|"~     The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a~     brief educational individual workshop that is meant to help Veterans better understand~     feelings of sadness and ways to improve their mood. This study is intended to evaluate and~     establish the workshop's effectiveness for use with Veterans in primary care settings.~      The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month~     period of time. Approximately 144 Veterans will participate in the study. Using a procedure~     like the flip of a coin, the participants will have a one in two chance of receiving the~     brief educational workshop or treatment as usual condition.~   "
59621|NCT02276794|"~     This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain,~     Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.~   "
59622|NCT02276781|"~     The investigators hypothesize that among people with lower extremity peripheral artery~     disease (PAD), biomarker levels are higher during time periods immediately preceding an~     acute coronary event compared to time periods not immediately preceding an acute coronary~     event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be~     measured at baseline and every two months during follow-up.~      The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD~     who experience an acute coronary event during follow-up, the investigators will determine~     whether biomarker levels measured immediately prior to the coronary event are higher than~     levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The~     investigators will determine whether participants who experience a coronary event (cases)~     have higher biomarker levels at the visit immediately prior to the event than participants~     who have not experienced a coronary event (controls) at the time of the case event. Specific~     Aim #2, Part 2. The investigators will determine whether participants who experience a~     coronary event (cases) have a greater increase in biomarkers during the time period leading~     up to the event compared to participants who have not experienced a coronary event~     (controls).~      To achieve these aims, the investigators will enroll up to 650 participants with PAD and~     follow them prospectively, measuring blood samples every two months, and ascertaining the~     presence of acute coronary events every two months.~   "
59623|NCT02276768|"~     This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and~     GIC-1002 with placebo using a barostat distender. The healthy male and female volunteers~     randomized to one of 5 possible treatments will be exposed to rectal distension following a~     3-day treatment TID. The barostat methodology is a well-established and validated way to~     assess visceral pain. Visceral pain will be evaluated during exposure to varying distender~     pressures using a visual analog scale.~   "
59624|NCT02276755|"~     The goal of this clinical trial is to investigate the preventive role of vitamin D~     supplementation in school age children in a high transmission setting. The investigators~     hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI,~     (2) vitamin D supplementation will lead to greater reductions in active TB incidence, and~     (3) children with the lowest vitamin D status at baseline will gain most from the~     intervention.~   "
59636|NCT02276599|"~     This study is designed to investigate the ability of pleth variability index (PVI) to~     non-invasively predict fluid responsiveness in mechanically ventilated children. Patients~     undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be~     recruited for this study. These patients are ideal candidates because very few deviations~     will be made from standard clinical practice. All patients will already be under general~     anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with~     intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation~     from clinical practice will include an abbreviated echocardiographic exam, application of~     the Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the~     interventional cardiologist.~   "
59722|NCT02275468|"~     a prospective, multicenter (outpatient clinics of the three participating hospitals in~     Beijing), double blinded and randomized placebo-controlled study.~      The study consisted of a 2-week run-in period and a 12-month treatment period.~   "
59625|NCT02276742|"~     The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different~     technology-supported approaches to engaging 300 individuals with diabetes and concurrent~     chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction~     of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of~     4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile~     self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT~     plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms~     primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and,~     secondarily in terms of physical activity, blood pressure, fasting lipids, medication~     requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12~     months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be~     based on logistic generalized linear mixed models (for binary outcomes) linear mixed models~     (for continuous outcomes), and random effects multinomial models (for outcomes with more~     than 2 levels, such as changes in medication management). In separate analyses of the~     intervention arm only, investigators will model self-monitoring adherence and examine~     possible associations between self-monitoring adherence and outcomes. The mediating effect~     of self-efficacy on the primary outcomes will be evaluated using structural equation models.~   "
59626|NCT02276729|"~     Individuals who have sustained a stroke are often left with residual deficits of the upper~     limb such as impaired movement and sensation. These deficits restrict functional use of the~     limb in everyday activities and can result in increased dependency upon others to engage in~     some tasks. Regaining independence through functional use of the arm and hand is an aim of~     occupational therapy rehabilitation. Mirror box therapy (MBT) is a relatively new innovation~     being introduced into occupational therapy interventions. Some studies have reported it to~     be beneficial in upper limb rehabilitation, however, these studies have not involved a~     sub-acute stroke population. This pilot study aims to provide robust evidence, using RCT~     design, as to whether this type of therapy may offer greater potential in functional gains~     in the sub-acute recovery period of stroke than standard rehabilitation of the upper limb~     alone.~   "
59627|NCT02276716|"~     Familial dysautonomia (FD) is a devastating hereditary disease in which the development of~     selective neuronal populations is impaired because of a deficiency of the protein IKAP~     (Slaugenhaupt, 2002). There is no known cure. Treatments are supportive, often ineffective~     and around half of all patients die before reaching age 40 (Axelrod et al., 2002).~      Phosphatidylserine is an FDA approved food supplement that was shown recently to correct the~     genetic abnormality and restore IKAP protein levels in cell lines derived from patients with~     FD (Keren et al., 2011) and a humanized mouse model of the disease (Bochner et al., 2013).~     Despite its safety and efficacy in this fragile population being unknown, many patients with~     FD are currently taking phosphatidylserine~      The investigators propose to conduct a safety, tolerability and early proof of concept~     efficacy study of phosphatidylserine in patients with FD. The study will be divided into two~     independent arms. The first phase of the study will be an open-label dose titration study to~     determine the safety and optimal dose of phosphatidylserine and its effect of normal IKBKAP~     mRNA levels in 40 patients with FD. The second phase will be a longitudinal observational~     study in which we will follow, on a yearly basis, patients with FD of all ages who opt to~     take phosphatidylserine. In this study, we will evaluate the long-term safety of~     phosphatidylserine in patients with FD and hope to determine whether phosphatidylserine has~     any impact on the clinical evolution of the disorder.~      Our long-term goal is to find an effective therapy that will improve the quality of life for~     patients with FD and alter disease prognosis. We believe that the promise of~     phosphatidylserine and its availability in health food shops warrants a controlled safety,~     tolerability and efficacy study to determine whether it should be taken by patients with FD.~     This study is not intended to determine whether phosphatidylserine has a new indication to~     treat FD.~   "
59628|NCT02276703|"~     Pain in hospitalized patients has received increasing attention, however due to its~     subjective nature, it has defied objective, quantitative measurements. If a patient is able~     to communicate, pain may be assessed using standardized sentences, visual analog scales~     (VAS) or plain numeric scales.~      When a patient is unable to communicate, a method that would allow the caregiver to~     continuously monitor patients' pain and alert the provider that the patient may be in pain~     would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing~     changes in skin conductance that can be used in patients who are unable to provide a~     subjective pain score. This study will compare the relationship between the measurements~     taken by the PainMonitor and pain scores given by communicative patients to evaluate the~     safety and efficacy of this monitor during planned, routine procedures.~   "
59629|NCT02276690|"~     Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at~     admission and more than 80% at intensive care unit discharge. Iron deficiency is also~     frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care~     Unit, critically ill patients are exposed to repeated blood samples and to other blood~     losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this~     leads to direct iron loss. Prevalence of iron deficiency may thus be very important at~     Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these~     patients, since inflammation induces an increase in plasma ferritin levels and a decrease in~     transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron~     deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be~     indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The~     characterization of iron metabolism regulation by the hormone hepcidin opened new ways for~     the understanding and the follow-up of these complex clinical situations (combining~     inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in~     hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low~     hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as~     a marker of iron deficiency in critically ill patients. To date, standard immunological~     methods of hepcidin quantitation are only proposed in the reasearch setting and could not be~     proposed in the clinical setting because it is too expensive. New approaches for hepcidin~     quantification, based on mass spectrometry are proposed and may be routinely implemented. We~     make the hypothesis that treating iron deficiency in critically ill anemic patients,~     diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit~     rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay~     and anaemia treatment.~      The aim of this study is to evaluate the medical economic interest of a new diagnostic~     method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry~     in critically ill anaemic patients.~   "
59630|NCT02276677|"~     Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the~     mechanisms for this effect in humans is not yet clear.~      In this study, the investigators will therefore examine the effect of a single dose of~     intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and~     functional magnetic resonance imaging activation of areas of the brain involved in food~     motivation.~   "
59631|NCT02276664|"~     The purpose of this study is to develop and test a self-help smoking cessation treatment for~     patients receiving a lung cancer screening computed tomography (CT) scan.~   "
59632|NCT02276651|"~     Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid~     leukemia in complete Remission (consolidation therapy)~   "
59633|NCT02276638|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The~     secondary objective is to evaluate any adverse events found during the clinical study.~   "
59637|NCT02276586|"~     Background: The actual literature is consistent in considering potential negative effects of~     sub-gingival prosthetic margins on the periodontal health, but no research has focused the~     attention on the type of prosthetic margin designs. Hence, the aim of the present study is~     to evaluate if a horizontal finishing line (deep chamfer preparation) may have a different~     influence on periodontal soft tissue in comparison with a vertical finishing line (feather~     edge preparation).~      Methods: A prospective randomized controlled double blind clinical trial with one single~     operator and three experienced examiners was performed. One hundred and six crowns were~     prepared with horizontal tooth preparation while ninety-four with vertical tooth~     preparation. All the margins were positioned within the periodontal sulcus, at 0.5mm~     sub-gingivally and all the all-ceramic restorations were cemented with resin cement.~     Periodontal Probing Depth (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival~     Bleeding on Probing (BOP) were recorded prior to tooth preparation and twelve month after~     crown cementation. Also, at 12 months follow-up, the gingival margin position was related to~     the crown margin position.~   "
59638|NCT02276573|"~     Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is~     1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and~     debilitating is characterized by erosive areas, ulcerated on an erythematous base with or~     without a keratinocyte lichenien network.~      The literature data moving towards an autoimmune origin, but the pathophysiological~     mechanisms of OLP remain unknown.~      This project represents the first part of a comprehensive project to examine the oral~     pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on~     Epstein-Barr Virus (EBV).~   "
59639|NCT02276560|"~     The purpose of this research study is to determine whether giving cisplatin and~     nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the~     lung at the time of surgery.~   "
59640|NCT02276547|"~     The purpose of this study is to evaluate the safety and initial performance of the Neovasc~     Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.~   "
59641|NCT02276534|"~     The investigator's goal is to address the need for the development of social interventions~     for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends~     established behavioral strategies with theatre techniques that emphasize the involvement of~     peers, play and performance. The resulting synergy extends promising pilot studies in a~     randomized group experiment.~   "
59642|NCT02276521|"~     In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer~     mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000~     doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease~     burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with~     a three-dose schedule, but not all girls received three doses of the vaccine. This means~     those girls that received reduced doses may not be fully protected against the HPV genotypes~     present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the~     licensed three-dose schedule, there is limited information about the effectiveness of~     reduced dose schedules in terms of immunogenicity and memory. There is growing evidence from~     other studies that two doses of HPV vaccine may be sufficient for protection. Reduced~     schedules would be of benefit in Fiji due to improved costs and logistics. This study will~     examine whether one or two doses of HPV vaccine provide similar immunological evidence of~     long-term protection to the standard three-dose schedule in terms of antibody titres to the~     genotypes present in the Gardasil®. To compare immunological memory responses between dosage~     groups, a dose of Cervarix ® will be administered to all girls so that the magnitude of the~     memory responses can be measured.~   "
59643|NCT02276508|"~     Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat~     gastrointestinal disorders and infections. The investigators will assess the safety and~     tolerability of this medication in Americans in a Phase 1 trial.~   "
59644|NCT02276495|"~     The purpose of the study is to determine the effect of a single injection adductor canal~     block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).~   "
59645|NCT02276482|"~     The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200~     mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.~   "
59646|NCT02276469|"~     The purpose of this study is to determine wether peer support is effective for the treatment~     of people with severe mental illness.~   "
59647|NCT02276456|"~     With no prior prospective study to demonstrate the benefit of an early post-discharge~     follow-up appointment in reducing readmission rates in the post-myocardial infarction (MI~     patient population, we propose to conduct the first randomized, prospective trial to better~     elucidate the association between early and standard follow-up on readmission rates. The~     investigators hypothesize that unlike heart failure or advanced valvular disease patients,~     the benefit of early outpatient follow-up in reducing readmission of post-MI patients will~     be less clear. Thus, the investigators primary aim will be to determine the effect of early~     outpatient follow-up post-discharge on 90 day all-cause readmission rates (exclusive of~     planned readmissions known at the time of discharge). Secondary aims are to describe 1)~     causes of readmissions within 90 days, 2) any cardiovascular-related complications and any~     deaths that occur from discharge through 90 days, 3) 30-day readmission rates and 4) median~     time to readmission among those readmitted. Finally, the investigators will examine the~     distribution of demographic, clinical and socioeconomic characteristic according to~     readmission vs. no readmission. The investigators do not expect to have sufficient endpoints~     for full predictive modeling, but believe this exploratory work will provide a foundation~     for future studies. The investigators postulate that the design and methodology of our~     current study could be used to answer similar questions in other subsets of patients.~   "
59648|NCT02276443|"~     The goal of this clinical research study is to learn if the use of molecular testing on~     tumors can improve response to treatment in patients with TNBC by guiding patients with~     chemotherapy-sensitive tumors to receive standard chemotherapy and chemotherapy-insensitive~     tumors to consider a clinical trial. Researchers want to compare the outcome of a study~     group which receive results of these tests with a group of patients who do not receive the~     results.~   "
61606|NCT02250820|"~     The study will examine the quality of two sedation techniques (dexmedetomidine and~     pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic~     echocardiography (TTE).~   "
59649|NCT02276430|"~     Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years.~     Their life expectancy has greatly improved due to the introduction of platinum-containing~     chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays,~     prevention or early detection of late adverse effects of TC treatment has become~     increasingly important. Current literature suggests that TC treatment, and specifically~     exposure to platinum agents, is associated with increased risk of cardiovascular morbidity~     and mortality. The precise role of treatment components like platinum in the pathogenesis of~     cardiometabolic changes and cardiovascular disease (CVD) warrants further investigation,~     since it is not known if CVD develops through direct platinum-induced damage of the vascular~     wall or by mediation through development of cardiometabolic riskfactors. The aim of this~     study is to identify risk factors for development for CVD after treatment for TC. A more~     profound insight into pathophysiologic mechanisms and identification of risk factors for~     CVDs is needed to facilitate development of preventive strategies and to optimize~     survivorship care.~   "
59650|NCT02276417|"~     The purpose of this study is to define the natural history and causes of chronic critical~     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator also~     wants to define the long-term physical and cognitive outcomes of this disease. The~     investigator will be looking at many clinical variables to try to define CCI.~   "
59651|NCT02276404|"~     Breast cancer surgery is associated with presurgical psychological distress and clinically~     significant side effects including postsurgical pain, nausea and fatigue. A few studies have~     examined how to intervene to assist women undergoing breast cancer surgery. For example~     presurgical hypnosis has been proven to decrease side effects and even intraoperative~     anesthesia use. Besides the more psychologically based interventions there are a few studies~     suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery~     patients.This study aims to investigate whether a presurgical relaxation training,~     acupuncture treatment or a combination of both therapies is able to reduce presurgical~     psychological distress an postsurgical side effects in breast cancer patients in comparison~     to usual care.~   "
59652|NCT02276391|"~     To establish bioequivalence of telmisartan orally administrated in two different ways:~     either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination~     tablet or with two telmisartan 40 mg tablets~   "
59653|NCT02276378|"~     To investigate the relative bioavailability and pharmacokinetics of the fixed-dose~     combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg)~     after food intake in comparison with those in the fasting state in healthy Japanese male~     volunteers~   "
59654|NCT02276365|"~     The objective of the study was to investigate whether there is a drug-drug interaction~     between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore,~     the relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs~     were given in combination compared with BI 10773 and pioglitazone given alone.~   "
59655|NCT02276352|"~     Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type)~     compared to one 15 mg meloxicam tablet (American type), and to investigate~     dose-proportionality over the dosage range 7.5 mg to 15 mg~   "
59656|NCT02276339|"~     This study aims to investigate the activity patterns of the peroneal muscle group, in~     individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared~     with individuals without ankle problems. The study also aims to determine the effect of a~     targeted exercise programme on this muscle group in patients with CAI.~      Research on this topic may provide important insight on the roles of these muscles in~     chronic ankle instability and investigate whether specific strengthening programmes are~     effective in this complex patient category.~   "
59657|NCT02276326|"~     Aim of the study is to evaluate the effects of a change in the intestinal microflora on the~     neuro-cognitive profile of patients with HIV infection receiving HAART treatment.~     Improvements will be evaluated with questionnaires on Quality of life and Cognitive and~     Behavior function.~      20 patients will be enrolled and will receive 4 sachets of VSL#3 per day.~   "
59658|NCT02276313|"~     BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry~     to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon~     catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.~   "
59659|NCT02276300|"~     Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast~     or gastric cancer with moderate HER2/neu expression.~   "
59660|NCT02276287|"~     Background: the study aimed to explore HIV positive patients' perceptions toward illness and~     treatment, and their associations with demographic and clinical variables, in particular~     with adherence.~      Methods: the study was conducted at the outpatients clinic of Infectious Disease of a~     University Hospital in the north of Italy. Patients were asked to fill out the Illness~     Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA~     copies/ml) and presence at the check up.~   "
59661|NCT02276274|"~     This is a randomized, open-label, crossover study to determine the effect of food when a~     combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as~     SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after~     breakfast in Japanese healthy adult male subjects.~   "
59662|NCT02276261|"~     This study has been designed as a prospective randomized trial to be performed at Bridgeport~     Hospital. Patients planning to undergo a laparoscopic or robotically assisted total~     laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by~     the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their~     preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If~     enrolled, they will be assigned a sequential study identification number. During their~     preoperative exam, a baseline POP-Q will be performed. Demographic information will be~     recorded from the electronic medical record.~   "
59663|NCT02276248|"~     This study is to evaluate the efficacy and safety of radiotherapy combined with GDP~     (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural~     killer/T-cell lymphoma patients with unfavorable prognostic factors.~   "
59664|NCT02276235|"~     The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the~     therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of~     life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese~     women.~   "
59667|NCT02276196|"~     Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based~     therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4~     inhibitors, may hold promise in preventing the onset and progression of diabetic kidney~     disease. However, the potential renoprotective effects of these agents, that are believed to~     be effectuated beyond glucose control, have not been sufficiently detailed in human~     diabetes.~      Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1~     receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.~      Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention~     with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.~   "
59668|NCT02276183|"~     Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there~     are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of~     functionality and mobility. From around 45-50 years onwards, there is a progressive loss of~     muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle~     protein synthesis in response to dietary proteins. Insufficient dietary protein may~     contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects~     body movement.~      Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D,~     Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and~     functionality. The investigators expect improved effects of a nutritional intervention~     combined with a physical activity program on mobility in healthy aging subjects with joint~     discomfort.~   "
59669|NCT02276170|"~     Acute kidney injury (AKI) in critically ill neonates is common and associated with~     significant morbidity and mortality. No targeted therapeutic treatment strategies have been~     established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic~     conceptual framework, this project will examine the medication aminophylline as a potential~     treatment approach for AKI.~   "
59670|NCT02276157|"~     This study was aimed to evaluate of the success rate and clinical usefulness of direct~     peroral cholangioscopy by using an ultra-slim upper endoscope for the diagnosis and~     treatment of bile duct diseases.~   "
59671|NCT02276144|"~     The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function~     abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk~     of pregnancy complications.~   "
59672|NCT02276131|"~     A human factors and home use study to assess whether subjects with diabetes and their~     caregivers can understand feedback received from the Vigilant Diabetes Management~     Application about their blood glucose patterns and whether the decisions made in response to~     device feedback are made in accordance with the intended use.~   "
59673|NCT02276118|"~     Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee~     system with a unique ball and socket post-cam mechanism was developed for use in total knee~     arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves~     prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence~     compared to an established successful prosthesis, Genesis II (Smith & Nephew, Memphis,~     U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound~     healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional~     plateaus faster than patients with Genesis II and the functional plateaus of patients with~     E.Motion-Pro are higher than those of patients with Genesis II.~   "
59674|NCT02276105|"~     The purpose of this study is to determine how appropriate and practically is the EQ-5D~     questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the~     change of quality of life.~   "
59675|NCT02276092|"~     This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the~     length of stay of patients admitted to hospital with a diagnosis of pneumonia. The~     antimicrobial stewardship program will be implemented in several hospitals in Ontario,~     Canada. The program will identify patients with pneumonia, review their charts and make~     recommendations to their attending physicians about antibiotic management.~   "
59676|NCT02276079|"~     The study is a proof-of-principle project to examine the safety and feasibility of~     implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic~     brain injury (mTBI). The study will define the extent to which the exercise program improves~     recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical~     status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).~   "
59677|NCT02276066|"~     This study investigates the mechanism by which kidney dysfunction perpetuates inflammation,~     immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will~     test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic~     critical illness contributes to decreased survival through the development of PICS. In~     chronic critical illness, the persistence of the inflammatory state may lead to capillary~     rarefication in the kidney causing accelerated chronic kidney disease. Progression of~     chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the~     features of chronic critical illness are consistent with the protein-energy malnutrition and~     muscle wasting associated with chronic kidney disease. Thus, the kidney can play a~     contributory role in chronic critical illness and PICS.~   "
59678|NCT02276053|"~     This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is~     effective in routine clinical practice for patients with epilepsy caused by a brain tumor.~   "
59679|NCT02276040|"~     The purpose of this study is to quantify the total blood serum levels of bupivacaine in~     OrthoPAT® collected blood 2 hours and 5 hours postoperatively.~      Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or~     undetectable levels of bupivacaine HCL. Reinfusion of collected blood from the OrthoPAT®~     device when used in conjunction with periarticular bupivicaine injections will not pose a~     bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.~   "
59680|NCT02276027|"~     To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162~   "
59759|NCT02274987|"~     This is a single arm multi-center pilot trial within the Pacific Pediatric Neuro-Oncology~     Consortium (PNOC). The current study will use a new treatment approach based on each~     patient's tumor genomic profiling consisting of whole exome sequencing and RNA sequencing as~     well as predictive modeling.~   "
59681|NCT02276014|"~     Summary:~      Chronic intake of foods low in vitamin A (retinol) and provitamin A forming an unbalanced~     diet with little variety is common in young individuals in the United Kingdom (UK)~     population and can lead to subclinical micronutrient deficiency. Provitamin A sources such~     as β-carotene are cleaved centrally by the β-carotene 15,15'-monooxygenase (BCMO1) into~     retinal, the precursor of retinol. However, the amount of β-carotene and retinol produced~     after ingestion of β-carotene is highly variable between healthy individuals, with~     approximately 40% of the subjects being classified as low responders. Several stable isotope~     studies have shown a large disparity between the most efficient converters and the most~     inefficient converters of β-carotene with variations of up to 8-fold. It is possible that~     differences in β-carotene response may be due to single nucleotide polymorphisms (SNPs) in~     genes involved in aspects of β-carotene conversion. Previous work has shown that carriers of~     both, the 379V and 267S+379V BCMO1 variant alleles had a reduced ability to convert~     β-carotene. More importantly, 44% of the western population have the 379V haplotype. A high~     percentage of the Western population may therefore not be able to achieve adequate vitamin A~     intake if dietary β-carotene is a major source of their vitamin A intake. This is of~     particular relevance to vegetarians, to young individuals aged 19-24 years who have lower~     intakes of preformed retinol than any other age group, and to pregnant women. The aim of~     this study is to establish whether the maximum recommended dose for β-carotene of 7mg/day by~     the British Expert Committee on Vitamins and Minerals (EVM) can overcome the SNP effect in~     the BCMO1 enzyme.~      Hypothesis:~      The investigators hypothesize that the current maximum recommended intake of 7 mg of~     β-carotene per day cannot overcome the low convertor phenotype in BCMO1 to fulfill vitamin A~     requirements in these people.~   "
59682|NCT02276001|"~     The primary objective of this study is to assess the effects of cyclosporine on the~     pharmacokinetics of K-877 in healthy adult subjects.~   "
59683|NCT02275988|"~     The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics~     of K-877 in healthy adult subjects.~   "
59684|NCT02275975|"~     The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of~     K 877 in healthy adult subjects.~   "
59685|NCT02275962|"~     The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of~     K-877 in healthy adult volunteers.~   "
59686|NCT02275949|"~     This study will evaluate acupuncture's effect of preventing vasospasm after SAH.~      A total of 80 participants will be recruited and will be randomized to a study group or a~     control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at~     every session in a study group, while mock transcutaneous electrical nerve stimulation(mock~     TENS) and sham intradermal acupuncture will be carried out in a control group.~   "
59687|NCT02275936|"~     This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the~     safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR)~     modulator at doses near the expected therapeutic exposure level in preparation for Phase 2~     studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when~     launched.~   "
59688|NCT02275923|"~     The purpose of this study is to investigate the use of subcutaneous impedance measured with~     an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status~     monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous~     impedance and compare with the fluid status assessed by the volume removed from the~     hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be~     evaluated between dialysis sessions.~   "
59689|NCT02275910|"~     This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be~     conducted in 2 parts:~        1. Part 1 will be the dose escalation portion of this study to determine the maximum~          tolerated dose in subjects with solid tumors, and~        2. Part 2 will comprise cohort expansions to further characterize the safety and~          tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with~          solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.~   "
59690|NCT02275897|"~     The purpose of this study is to investigate if prolonging the speed of injection during~     spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements~     thereby making it safer for the mother and foetus.~   "
59691|NCT02275884|"~     This study evaluates plasma concentrations of pharmacologically active constituents of~     chocolate and their effects on motor and non-motor symptoms of Parkinson's disease.~     Following one week of abstinence from cocoa-containing products, patients with Parkinson's~     disease will be randomized to receive either dark or white chocolate. After one week of~     chocolate consumption, patients will then cross over to white or dark chocolate,~     respectively, and take the corresponding chocolate product for another week. Blood samples~     will be taken at baseline, week 1 and week 2 to examine plasma concentrations of~     pharmacologically active constituents of chocolate at all three timepoints. Moreover,~     patients will be clinically examined for motor and non-motor symptoms at all visits.~   "
59692|NCT02275871|"~     This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)~     to MRI as a screening tool for breast cancer.~   "
59693|NCT02275858|"~     Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by~     enabling endoscopic access deep into the small bowel. Using a combination of antegrade~     (through the mouth) and retrograde (through the anus) approaches, a large portion of the~     small bowel can be examined. Access to the proximal small bowel through the pylorus using~     the antegrade approach is straightforward but intubating the distal small bowel through the~     ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an~     enteroscopy stiffening wire has been developed. The purpose of our double blind placebo~     controlled randomized cross over study is to evaluate the performance of the enteroscopy~     stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon~     assisted enteroscopy.~   "
59694|NCT02275845|"~     Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high~     risk for GDM, an open label randomized controlled trial' The Medico-GDM trial~   "
59695|NCT02275832|"~     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for~     beard enhancement.~   "
59696|NCT02275819|"~     This is a research study being conducted to better understand the impact of exercise~     training on changes on the structure and function of the heart. Exercise training in~     patients with heart failure has been shown to be beneficial at decreasing symptoms of heart~     failure and improving overall functional capacity or capacity to exercise. However the~     mechanisms responsible for this are still unclear. This study will look specifically at how~     exercise creates changes within the hearts filling ability, the hearts pumping strength as~     well as the hearts ability to rebuild.~   "
59760|NCT02274974|"~     Study to compare between efficacy of post-caesarean section infiltration with lidocaine and~     epinephrine versus lidocaine only to reduce post-incisional pain.~   "
59699|NCT02275780|"~     To establish a new treatment option for treatment-naïve participants with HIV-1, the~     efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).~     Participants will receive double-blind treatment during the 96-week Base Study. Eligible~     participants in either of the Base Study groups will continue to receive the~     doravirine-containing regimen open label for an additional 96 weeks in the Extension Study.~     The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to~     darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or~     EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid~     (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of~     doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be~     assessed.~   "
59700|NCT02275767|"~     The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to~     examine histologic wound healing following ridge preservation using cortical bone allograft,~     cancellous bone allograft, or a combination of both cortical and cancellous bone allograft.~     This entire protocol involves procedures that are standard care. All materials are~     FDA-approved materials being used in an FDA-approved manner. The test group subjects will~     have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This~     test group will be compared to two active control groups - one using 100% cortical FDBA and~     the other using 100% cancellous FDBA. The null hypothesis is that there will be no~     significant difference in formation of new vital bone between treatment groups (primary~     outcome).~      Each subject will provide a single non-molar tooth site for study treatment. After tooth~     extraction, the graft material will be placed and covered by a non-resorbable membrane.~     Following 18-20 weeks of healing, the dental implant will be place, at which time a core of~     bone will be removed from the site as part of the preparation for the implant. The core~     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation~     and secondary histologic outcome of % residual graft material.~   "
59701|NCT02275754|"~     This proposed 5-year Redes En Acción research study involves a mixed-methods approach that~     occurs in two phases across two distinct and diverse HL communities. The RCT involves a 2 X~     4 randomized repeated measures design with experimental condition (combined patient~     navigation [PN] over 3 months with access to LCNS PN services[PNLCNS] vs. a PN only~     condition) as the between-groups factor, and time-point (baseline/pre-randomization [T1];~     post-PNLCNS [about 3-months post-T1; T2], and about 6- [T3] and about 12-months [T4]~     follow-up post-T2) as the within-groups factor; total follow-up is 15 months. The~     investigators will compare the effects of the PNLCNS and PN only conditions on QOL and~     treatment follow-up compliance in 300 (after attrition; n=100, Chicago and n=100, San~     Antonio) breast, colorectal and prostate HL cancer survivors with no evidence of metastatic~     disease.~   "
59702|NCT02275741|"~     The aim of this study is to determine whether prophylactic vaccines recommended are~     effective and safe in patients with multiple sclerosis(MS) under MS-specific therapy.~   "
59703|NCT02275728|"~     This study evaluates the action of the pelvic floor muscle training with and without EMG~     Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post~     menopausal women and their quality of life before and after the interventions.~   "
59704|NCT02275715|"~     The primary aim of the project is to develop and pilot a manualized, individually delivered~     Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum~     disorder (ASD) to assess feasibility and parent acceptance of the program. The secondary aim~     of the project is to assess the success of the PT-F program in improving mealtime behavior~     problems when compared to the wait-list control.~      Exploratory aims include obtaining preliminary data on the impact of PT-F on child and~     parent functioning (reducing parent stress and improving parent sense of competency and~     parent-child interactions at mealtime), assessing the impact of treatment on interfering~     behaviors around mealtime/snack times, and measuring nutritional improvements after~     treatment.~   "
59705|NCT02275702|"~     The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small~     dose of IV dexamethasone during induction anesthesia in association to pre and postoperative~     intercostal nerve block, improves quality of recovery of thoracoscopic lung resection~     patients.~   "
59706|NCT02275689|"~     This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I)~     and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.~      The outcome of both methods will be compared to the physical therapy treatment (groupIII)~   "
59707|NCT02275676|"~     Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in~     IBD is often limited by chronic inflammation, but is also commonly reduced by missing~     intestinal segments due to previous operations. Patients are predominantly affected by~     malnutrition, which is often resembled by weight loss, specific micronutrient deficits such~     as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and~     zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively~     limited to active phases of the disease. Causes of malnutrition can be inadequate food~     intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition~     itself is associated with a delayed recovery of impaired wound healing, reduced quality of~     life and longer hospital stays. Therefore, observation and modification of the nutritional~     status should be an integral part of therapy in IBD patients.~      The primary objective of our study is to investigate the influence of the disease on the~     resting energy expenditure and nutritional status during acute inflammation and clinical~     remission of the disease. Secondary objectives are to assess possible nutritional~     deficiencies. On the other hand it is well known that patients with IBD are at increased~     risk for coronary heart disease. Therefore, another secondary focus of our observational~     study is whether the composition of the HDL proteins is changed towards pro-atherogenic~     HDL-proteins and whether possible changes occur in patients in clinical remission or with~     active disease.~   "
59708|NCT02275663|"~     The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to~     fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid~     leukemia.~   "
59761|NCT02274961|"~     This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non~     erosive Reflux Disease than placebo.~   "
64947|NCT02207218|"~     This study is conducted in Asia. The aim of this study is to evaluate the safety and~     efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in~     the setting of routine clinical practice.~   "
59709|NCT02275650|"~     The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in~     the maintenance of vitamin D levels achieved during the summer in Finland. The investigators~     randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2~     standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum~     25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control~     group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies~     were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level~     analyses.~   "
59710|NCT02275637|"~     The study is a prospective multicenter registry. Consecutive patients with indications of~     implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be~     enrolled.~      The primary objective of the study is to determine the predictors of appropriate~     anti-tachycardia therapy (with shock) in a non-selected population of patients implanted~     with an ICD.~      Secondary objectives of the study are:~        -  the incidence of anti-tachycardia therapies;~        -  the predictors of inappropriate therapy and onset of arrhythmia burden;~        -  the adherence to the current guidelines in the Italian clinical practice;~        -  the predictors of heart failure (HF) onset and response to cardiac resynchronization~          therapy (CRT).~   "
59711|NCT02275611|"~     This study will test in individuals who have alcohol dependence (alcohol addiction) the~     hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during~     medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the~     outpatient setting will decrease drinking.~   "
59712|NCT02275598|"~     The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg~     Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).~   "
59713|NCT02275585|"~     This study evaluates the supervivence of cirrhotic patients that develop portal vein~     thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.~   "
59714|NCT02275572|"~     Objective: To evaluate the clinical and economic impact of the application of an algorithm~     to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8~     or more medications), not institutionalized.~      Design: randomized, open, multicenter and two branches of parallel intervention clinical~     trial.~      Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the~     support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to~     doctor his findings and reach a consensus and decide which recommendations will be presented~     to patient. Control intervention: usual procedure.~      Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP~     consultations, hospital emergency department and hospital admissions for acute illness, c)~     pharmaceutical expenditure, d) restart medication e) complications underlying diseases.~     Follow-up control at 1 month (security) and at 3, 6 and 12 months.~   "
59715|NCT02275559|"~     Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in~     improving their asthma control and symptoms as well as their quality of life are important~     goals in clinical management. This study will test the effect of a widely-available~     mindfulness training program in improving asthma control and symptoms and quality of life~     among patients with asthma, and explore the relationship between asthma control and a number~     of factors, including how well patients perceive their respiratory symptoms.~   "
59716|NCT02275546|"~     The purpose of the study is to assess the performance and safe use of the vaginal ring~     applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in~     healthy women~   "
59717|NCT02275533|"~     This randomized phase II trial studies how well nivolumab works in eliminating any remaining~     cancer cells and preventing cancer from returning in patients with acute myeloid leukemia~     that had a decrease in or disappearance of signs and symptoms of cancer after receiving~     chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different~     ways by targeting certain cells.~   "
59718|NCT02275520|"~     The investigators will compare the success rates and time to successful IO access during~     simulated adult resuscitation.~   "
59719|NCT02275507|"~     The purpose of this study is to determine the normal hemoglobin curve during cesarean~     delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to~     detect life-threatening bleeding earlier.~   "
59720|NCT02275494|"~     Leg length discrepancy (LLD) is a complication of THA and may result in patient~     dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature,~     LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at~     which a LLD is clinically important is still a matter of debate. The aim of this study was~     to determine the influence of non-corrected LLD after THA on patients' reported hip function~     and quality of life. This prospective cohort study was conducted at Sundsvall Teaching~     Hospital in Sweden after it was approved by the regional ethics committee at Umeå University~     (No. 07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with~     unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.~     Informed consent was obtained from all patients. Patients with secondary OA, previous~     spinal, pelvic, or lower limb injuries or fractures were excluded.~      The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis~     (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the~     EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at~     follow-up at 1 year postoperatively. The posterolateral approach was used in all operations.~     LLD was measured on the postoperative x-rays. patients were divided into three groups:~     shortening group where the operated leg was more than 5mm shorter compared with the~     contralateral side, the restoration control group where the operated leg was within 5mm~     shortening and 9mm lengthening compared with the contralateral side, and the lengthening~     group where the operated leg became more than 9mm longer compared with the contralateral~     side.~   "
59721|NCT02275481|"~     This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD~     subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet~     the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate~     inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18~     mcg once daily (QD), each given for 90 days.~   "
81548|NCT01990027|"~     The SKSC is a continuous database with the objective of a standardized diagnosis and~     monitoring of patients with kidney stones as well as the establishment of a Biobank.~   "
59723|NCT02275455|"~     The worldwide prevalence of autism is constantly increasing. People with autisms have~     difficulties in communication and social interaction resulting from atypical perceptual and~     information processing, leading to the accumulation of anxiety. Extreme overloading~     experienced internally may not be visible externally. Identifying stressful situations at an~     early stage may avoid socially problematic behavior from occurring, such as self-injurious~     behavior. Activation of the autonomous nervous system (ANS) is involved in the response to~     anxiety, which can be measured through heart rate variability and skin conductance with the~     use of a portable device, non-intrusively and pain-free. Thus, developing innovative~     analysis of signal perception and reaction is necessary, mainly for the non-communicative~     individuals with autism.~   "
59724|NCT02275442|"~     The link between precarious situations and health conditions are more described in previous~     study. Precarious situations are more frequent and complex especially in rural areas. There~     are recognized like a risk factor of complications during pregnancy and delivery. It's~     necessary to describe antenatal cares for rural women in precarious situations to prevent~     those situations, to understand their difficulties in order to reduce inequalities and~     health spending.~      The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women~     and the strategies developed to overcome them. Recognized earlier precarious situations and~     valorized General Practitioners and restore them to the follow-up or parturient women.~   "
59725|NCT02275429|"~     Acute consequences of ultramarathon running are still unknown as very little research has~     been done on the matter. The investigators will assess the consequences on the metabolism of~     runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature~     suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of~     metabolites in systemic inflammatory response syndrome. The purpose of this study is to~     assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon~     runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion~     Island every year in October.~   "
59726|NCT02275416|"~     This study, with 20 patients participating, will examine the safety and tolerability for the~     ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.~   "
59727|NCT02275403|"~     The purpose of this study is to determine whether the addition of acupuncture to standard~     treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by~     patients with breast cancer or multiple myeloma, during or following treatment with~     neurotoxic chemotherapy.~   "
59728|NCT02275390|"~     The study aims to test the effectiveness of a nurse-led psycho-education program based on~     motivational interviewing technique for Chinese patients with first-onset mental illness~     over a 12-month follow-up. A randomized controlled trial will be conducted with 180 Chinese~     patients with schizophrenia newly referred to one outpatient clinic in Hong Kong. They will~     be randomly assigned to either the eight-session nurse-led psycho-education program or usual~     psychiatric outpatient care (both n=90). The patients' general and mental health, illness~     insight, self-efficacy, services utilization, and hospitalization rates were measured at~     recruitment and one week, six months and 12 months post-intervention.~   "
59729|NCT02275377|"~     This research aims to evaluate the effects of inspiratory muscle training (IMT) on blood~     pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects~     with hypertension.~   "
59730|NCT02275364|"~     The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo~     strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the~     strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis~     techniques derived from physiological data collected during scanning.~   "
59731|NCT02275351|"~     The purpose of this study is to characterize the safety, tolerability, and efficacy of~     topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with~     Androgenetic Alopecia (AGA).~   "
59732|NCT02275338|"~     To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to~     inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and~     to assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without~     the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction~     with a nasogastric tube.~   "
59733|NCT02275325|"~     Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular~     nerve, which slowly grows within the internal auditory canal and then into the~     cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive~     alteration of vestibular function allows the gradual implementation of central adaptive~     mechanisms called vestibular compensation. The total unilateral vestibular deafferentation~     induced by the surgical tumour removal suddenly leads to a decompensation of this previously~     compensated situation, which explains why most patients report severe vertigo immediately~     after surgery and which is responsible for perturbations of the postural control~     (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013)~     suggested that preoperative and regular physical activity would limit the adverse effects of~     surgical removal on balance control. Also, patients benefited faster and better from the~     postoperative vestibular rehabilitation.~      Thus, preoperative vestibular rehabilitation, including physical and balance exercises,~     could help to limit postoperative balance disorders and promote postoperative balance~     compensation. This could lead to a decrease in the duration and cost of the postoperative~     management and faster improvement of quality of life.~   "
59734|NCT02275312|"~     The objective of this study is to evaluate the effectiveness of BoNT-A on functional~     improvement in patients with post-stroke upper and/or lower limb spasticity in the early~     stage of spasticity development, according to routine clinical practice.~   "
59735|NCT02275299|"~     This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate~     Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).~   "
59762|NCT02274948|"~     This study expects to evaluate the use of metformin in the management of obese children.~     Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had~     been shown in the investigators previous work.~      This study will look at the effect of metformin on changes in insulin resistance, fatty~     liver state, body fat content, BMI and other metabolic derangement.~   "
59763|NCT02274935|"~     This study examines the effect of balance and walking exercise on cognition and mobility in~     people with Multiple Sclerosis.~   "
59736|NCT02275286|"~     Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response~     measure in two cohorts of patients:~      Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically~     recommended metastasectomy of limited to lung metastases soft tissue sarcoma.~      Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Phase I: escalating~     dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction)~     Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is~     developed to analyse different biomarkers predictive value.~   "
59737|NCT02275273|"~     The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics~     of adnexal masses with their anatomopathological characteristics.~   "
59738|NCT02275260|"~     The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to~     compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new~     subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical~     data from the literature.~   "
59739|NCT02275247|"~     To investigate whether stellate ganglion block is helpful to brain protection during cranial~     aneurysm surgery~   "
59740|NCT02275234|"~     The purpose of this study is to investigate whether simple psychological interventions can~     be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the~     psychological wellbeing of survivors of cardiac arrest during their recovery.~   "
59741|NCT02275221|"~     Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV~     infected patients in a number of different immunological assays, the investigators hope to~     identify any changes in the number and function of these immune cells and to investigate how~     these changes contribute to viral persistence and disease progression.~   "
59742|NCT02275208|"~     This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure.~     Subjects who meet the eligibility criteria will be considered for study participation and~     will be followed through 12 months.~   "
59743|NCT02275195|"~     Through bio-sampling this study investigates the relationship between the frequency and~     function of the cells of a patients immune system and how these change and impact on the~     outcome of alcoholic hepatitis. the investigators will examine the role of different cells~     of the immune system and how they may determine the outcome of this condition. The~     investigators will also look at how established treatment strategies impact on the frequency~     and function of these cell subsets.~   "
59744|NCT02275182|"~     Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can~     lead to a reduced ability and seriously affect the quality of life of patients, increase~     personal and social burden, POCD may also increase mortality.POCD can occur at any age, but~     the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are~     more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by~     preoperative cognitive function and psychological scales postoperative assessment, the main~     recommendation of the agreed test methods include, Rey auditory verbal test, the connection~     test, digit span test. In this study, preoperative mini-mental state examination (MMSE)~     screening, comprehensive neurological function during hospitalization for memory, attention,~     executive function and exercise capacity test, and telephone follow-up after discharge Scale~     Revised (TICS-M) test.~      Few study showed that dexmedetomidine may improve cognitive function in young patients~     others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery.~     These results conflict and it is necessary to carry out large-scale, multi-center,~     randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD~     incidence or not for elderly patients.~   "
59745|NCT02275169|"~     Aim of the study is to evaluate the effect of highly purified human follicle-stimulating~     hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from~     infertile male patients with non-obstructive azoospermia of unknown origin.~   "
59746|NCT02275156|"~     The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after~     a single 140 mg subcutaneous (SC) dose in adults with normal renal function or severe renal~     impairment or end-stage renal disease (ESRD) receiving hemodialysis.~   "
59747|NCT02275143|"~     Currently patients with certain cancer usually have routine follow up (Computed Tomography~     of Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The~     study proposal allows the evaluation of the coronary arteries by modifying the current CT~     TAP technique without significant additional procedures, intravenous contrast or radiation -~     i.e. an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The~     question is does performing Computed Tomography (CT) of the thorax in such a way confer~     important additional information about cardiac risk? At the same time the investigators need~     to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate~     other structures in the chest. A recent small retrospective study has using a similar~     technique suggests that it may in fact improve image quality due to less cardiac related~     motion artefact.~   "
59748|NCT02275130|"~     The voice is an indispensable source of human communication. Current time puts high demands~     on the quality of voice in most professions. Organic or functional changes of vocal cords~     associated with their insufficiency lead to a deterioration of voice quality, voice fatigue,~     hoarseness or breathing difficulties. This has adverse psychological, social and economic~     consequences for the patient, the employer and its surroundings. The injection techniques~     can be performed under general and local anaesthesia. The defined injectable substance is~     inserted directly in the vocal cords, which increases its volume and results in an almost~     immediate improvement of the voice quality. For injection can be used various materials,~     e.g. autologous fat, calcium hydroxyapatite, silicone, and others. Injection techniques are~     less invasive, associated with less perioperative morbidity. Operation can be also performed~     under local anaesthesia in selected patients, therefore is preferred for patients with~     multiple comorbidities and risk of general anaesthesia.~   "
59749|NCT02275117|"~     The purpose of this study is to assess ALD403 in the prevention of migraine headache in~     chronic migraineurs.~   "
59789|NCT02274597|"~     The aim of this study is to assess the impact of different environmental factors on the~     ability for a thermistor-based epitympanic thermometer to accurately read the temperature of~     a normothermic individual and thereby estimate their feasibility and reliability in the~     austere pre-hospital setting.~   "
59750|NCT02275104|"~     MIGAT will develop and transfer software tools to assist ablation therapy of cardiac~     arrhythmias. The scientific background and objectives of MIGAT differ between atrial and~     ventricular arrhythmias, because the knowledge on structure-function relationships and the~     definition of ablation targets are different.~      Hypothesis: The combination of body surface mapping and imaging will enable a comprehensive~     non-invasive assessment of cardiac arrhythmia mechanisms and localization, myocardial~     structural substrate, and cardiac anatomy, all of which should be of value to better define~     targets for ablation therapy. No software solution is currently available for multimodal~     data processing, fusion, and integration in 3-dimensional mapping systems to assist~     ablation. Because such a development requires a trans-disciplinary approach (cardiac~     electrophysiology, imaging, computer sciences), it is likely to emerge from an academic~     initiative.~      Objectives: MIGAT will gather resources from the Liryc Institute (L'Institut de Rythmologie~     et Modélisation Cardiaque), the Inria (Institut National de Recherche en Informatique et en~     Automatique) and the University Hospital of Bordeaux to develop a computer-based solution~     with high expected impact on the daily management of cardiac electrical disorders. The~     research program will benefit from the MUSIC (Magnetom Avanto, Siemens, Erlangen, Germany)~     equipment recently funded as part of the Investissement d'Avenir program, and combining~     state-of-the-art electrophysiology and magnetic resonance imaging technology. MIGAT will~     involve software engineers, computer science researchers, cardiologists, radiologists and~     clinical research personnel with the following objectives:~        -  Development of a multimodal data processing software to assist cardiac ablation~        -  Optimization and Validation of the software in terms of user experience~        -  Optimization and Validation of the software in terms of clinical performance~        -  Optimization of software quality compatible with subsequent device certification and~          randomized-controlled evaluation~   "
59751|NCT02275091|"~     Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease~     and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients~     with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before~     age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD~     so that interventions to prevent heart disease and stroke can be undertaken.~   "
59752|NCT02275078|"~     The purpose of this project is to conduct a pilot study evaluating the feasibility and~     potential benefits of a phone assessment/reporting system (tele-system) in addition to a~     written action plan and nurse case manager support to improve patients' adherence to COPD~     treatment in those at risk for exacerbations.~      Primary objective: explore the potential benefits with respect to patient's adherence, i.e.,~     prompt use of the antibiotic and/or prednisone in the event of an exacerbation, increased~     adherence to maintenance medication; to increase patient's self-efficacy in self-managing~     their disease; and to use more efficiently program resources, i.e., the case-manager.~      Secondary objectives:~      To assess the proportion of patients who effectively self manage exacerbations by using~     their COPD Action Plan~      To assess self management of COPD patients with respect to the increased adherence to~     regular respiratory medication, (SmartInhaler electronic monitoring);~      To assess increased self-efficacy in COPD patients identifying and managing exacerbations~     (baseline vs after 12 months);~      To assess symptoms recovery, health status improvement, and prevention of ER visits and~     hospital admissions for COPD exacerbations.~      To assess the efficiency in using program resources,~      To evaluate the feasibility of this treatment approach and to provide pilot data (needed for~     a larger multi-centre clinical trial;~      To evaluate the feasibility and need of assessment during and after exacerbation onset,~     health-related quality of life and physical activity;~      To evaluate the safety of this approach; this is in terms of the delay in starting~     prednisone and an unfavourable outcome (ER visits and/or hospitalization).~   "
59753|NCT02275065|"~     This study will investigate the short-term antiviral potency, safety, plasma~     pharmacokinetics (PK), and the PK/pharmacodynamic (PD) relationship (the dose-response~     relationship) of GS-9883 at multiple doses in antiretroviral (ART) treatment-naive adult~     subjects and subjects who are ART-experienced but are currently off of ART therapy. Up to 32~     participants will be enrolled in the study.~   "
59754|NCT02275052|"~     This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete~     block design cross-over study.~      The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on~     EET as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally,~     the effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients~     will be characterized.~      Approximately 298 participants will be screened and, assuming 35% of these will not be~     eligible for randomization; approximately 194 participants will be randomized.~      Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1~     participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment~     Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI~     62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder~     inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash~     out period of 12-17 days. The total duration of patient participation, including the~     Follow-Up will be approximately 30 weeks. All participants will be provided with albuterol~     for use on an as needed (prn) basis throughout the run-in, washout and study treatment~     periods while on investigational product.~   "
59755|NCT02275039|"~     This phase I trial studies the side effects and recommended dose of the combination of~     p53MVA vaccine (modified vaccinia virus ankara vaccine expressing tumor protein p53 [p53])~     and gemcitabine hydrochloride in treating patients with ovarian epithelial cancer that has~     come back. Vaccines made from inserting a laboratory-treated gene into a person's tumor~     cells may help the body build an effective immune response to kill tumor cells that express~     p53. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving modified vaccinia virus ankara vaccine~     expressing p53 together with gemcitabine hydrochloride may work better in treating patients~     with ovarian epithelial cancer.~   "
59756|NCT02275026|"~     The purpose of this study is to understand how elderly individuals regain their cognitive~     skills following general anesthesia. The investigators will compare an age stratified group~     of volunteers who will be evaluated with a series of cognitive tests and a functional MRI.~     The participants will then be administered general anesthesia for two hours. The~     investigators will then assess the participants using state of the art tools to determine~     when participants return to their cognitive baseline.~   "
59757|NCT02275013|"~     To assess the effects on outcome of levosimendan with respect to timing of its~     administration on the postoperative course of high-risk cardiac surgery patients in a~     retrospective observational study.~   "
59758|NCT02275000|"~     The aim of this study is to develop and assess the feasibility of a physiotherapy~     intervention for people with functional motor symptoms (also known as psychogenic~     neurological symptoms and conversion disorder). Participants will be randomised to receive~     the intervention or a treatment as usual control.~   "
59764|NCT02274922|"~     For a long time, culture was the only way to detect Campylobacter. It appears that rapid~     immunochromatographic tests (ICT) have detected more positive cases compared to culture,~     ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT~     which are really interesting tools to use since they allow a diagnosis in about 15 min, in~     comparison to different methods of detection even serology.~   "
59765|NCT02274909|"~     To compare the influence of a training program with Pilates and PNF methods to elderly women~     on the strength gains and motor control during voluntary contractions~   "
59766|NCT02274896|"~     The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that~     is impregnated with a cocktail of three well known anti-microbials~   "
59767|NCT02274883|"~     This study is intended to evaluate the nutritive effects of study formulas on growth and~     cognitive outcomes.~   "
59768|NCT02274870|"~     Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing~     total knee replacement (TKR). However the resulting motor blockade can lead to decreased~     quadriceps muscle strength and delayed functional recovery.The purpose of this study is to~     compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain~     control and functional recovery~   "
59769|NCT02274857|"~     The study is a prospective, multicenter, randomized, single-blinded study to assess the~     safety and effectiveness of FIRM procedures followed by conventional ablation including PVI~     versus a standard PVI procedure for the treatment of persistent atrial fibrillation.~   "
59770|NCT02274844|"~     Medication adherence is especially critical in regions like rural Alabama, where residents~     have among the worst health outcomes in the US. This project was designed in collaboration~     with our community member partners and builds on a 5-year partnership of community-engaged~     research on diabetes peer coaching interventions and our experience with peer storytelling.~     The investigators will test the hypothesis that an intervention designed within the Corbin~     and Strauss framework can improve adherence and health outcomes compared to usual care.~   "
59771|NCT02274831|"~     The purpose of this study is to see if patients who receive an email reinforcing their~     discharge instructions after being discharged from the emergency department will have an~     affect on follow-up care with their primary physician.~   "
59772|NCT02274818|"~     The investigators are conducting a cluster randomized trial in a sample of 63 internal~     medicine (IM) training programs that are randomly assigned to either the current duty hour~     standards or less restricted flexible duty hour standards.~      The trial includes a main protocol in which all randomized IM programs participate and two~     substudies. Time and Motion and Sleep and Alertness, each conducted at a subset of IM~     programs and focusing on more detailed data collection at the intern level.~      The main protocol will examine patient safety and costs as well as quality of education. The~     Time and Motion substudy examines additional educational outcomes. The Sleep and~     Alertness substudy examines intern sleep time and alertness.~   "
59773|NCT02274805|"~     The purpose of the study is to gather tissue (from the neck region), specimens (blood and~     urine) and medical record data from many patients and store them in one place so that~     scientists have the information they need to conduct research and learn about new ways to~     predict, identify and treat illness, specifically those related to obesity and diabetes.~   "
59774|NCT02274792|"~     The purpose of this study is to learn more about the immune response to etanercept produced~     using a modified process in patients with plaque psoriasis.~   "
59775|NCT02274779|"~     There is an increasing number of reports describing the existence of a proportion of~     prostate cancer patients who present with a reduced number of metastases (<5 lesions) at~     relapse. This oligometastatic status has also been recognized in other tumor types such as~     melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the~     management of these malignancies in that a more radical treatment such as surgical resection~     has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with~     tracers such as choline or acetate are reliable tools to help with the diagnosis of~     oligometastatic disease after biochemical treatment failure in prostate cancer. An~     aggressive treatment combining androgen depriving therapy (ADT) and and high-dose~     irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these~     oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong~     the failure-free interval between two consecutive ADT courses, or even cure selected~     patients with limited metastatic burden. In this study the investigators plan to assess~     biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5~     oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH~     agonists.~   "
59776|NCT02274766|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an~     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment~     of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel~     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the~     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in~     the evening, potentially reducing the negative impact of amantadine on sleep. This~     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER~     formulation than can be tolerated with an immediate-release formulation. The once-nightly~     dosing regimen may also provide enhanced convenience and compliance.~      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly~     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.~   "
59786|NCT02274636|"~     This research study is a randomized, controlled study developed to test how well a dry mouth~     product that contains xylitol affects some of the symptoms of gastroesophageal reflux~     disease (GERD. Individuals who experience symptoms of gastro esophageal reflux disease~     (GERD) and who are accepted into the study will be asked to report on the frequency and~     severity of several symptoms specific to the condition that occur during sleep. The study is~     composed of two phases:~      Phase one involves collection of baseline information for two weeks. Phase two is the~     intervention phase of the study. In this phase of the study, each subject will be randomly~     assigned (like flipping a coin) to use either the product of interest or a different dry~     mouth product for two weeks.~   "
59777|NCT02274753|"~     Colorectal cancers are the leading cancers for both sexes combined. They represent 15-20% of~     all cancers. This cancer has a severe prognosis, the survival rate at 5 years is around 55%~     and in France it is estimated, all colorectal cancers are responsible for an annual~     mortality of 15,000 patients. The prognosis of colon cancer knows no significant~     improvement.~      The treatment of colon cancer is surgical. It is intended for removal of colonic segment~     bearing the tumor with margins of healthy colon. The therapeutic attitude following the~     surgery is essentially driven by histopathology of the tumor. Adjuvant chemotherapy for all~     patients with localized stage II provides no benefit because the effectiveness of~     chemotherapy is limited and vulnerable to systemic toxicity. However, nearly 30% of patients~     with stage II disease will have a recurrence / metastasis. These patients could benefit from~     adjuvant chemotherapy.~      Intense research efforts have been made to identify markers predictive of relapse. Over~     thirty biological markers (eg. Mutations, deletions, chromosomal instability, ...) were~     highlighted. None of them has so far sufficient prognostic value (independent of TNM) to~     justify routine application in clinical practice in order to adapt the treatment of~     patients.~      The identification of new prognostic markers is a major issue for colorectal cancer. We~     showed that the intratumoral density memory T lymphocytes (CD45RO) and cytotoxic (CD8)~     strongly influenced the clinical outcome of patients. We have developed and validated a~     immunoscore technique intratumoral immune quantification and creates a platform to~     facilitate the clinical immuno transfer.~      We are currently conducting a large international retrospective study (22 centers,> 9000~     patients) with promotion of cancer immunotherapy Company (SITC) to validate the method~     immunoscore. At the same time, we are conducting a prospective multicenter study ImmuCol~     (National PHRC) to validate the prognostic value of immunoscore in colorectal cancer stage~     I-IV. The goal of inclusion has been achieved, as 420 patients were included for 18 months.~     Clinical follow-up will be 3 years after surgery.~      The program ImmuCol2 research takes advantage of the ImmuCol study to extend the~     investigation beyond the immunoscore to define the combination of interest, prognostic and~     theranostic parameters at diagnosis and during the clinical course patients with an~     objective of personalized medicine.~   "
59778|NCT02274740|"~     Primary Objective:~      To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in~     particular, the effects on plasma changes in triglycerides.~      Secondary Objectives:~      The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48;~     free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL)~     oxidation.~      The effect of lixisenatide on chronic low-grade inflammation present in non-insulin~     dependent diabetes mellitus (NIDDM) and obesity.~      The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of~     lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.~   "
59779|NCT02274727|"~     The three-year cumulative risk of a recurrent stroke, dependent on aetiology, is up to 25~     per cent. At present, preventing recurrence relies on a broad approach to reduce risk~     factors associated with atherosclerosis, heart disease and metabolic disorders. However,~     more specific interventions, such as anticoagulation and surgery or stenting, need~     aetiologic information. BIOSIGNAL aims to determine where the most promising biomarkers can~     help identify stroke aetiology and also predict recurrent stroke. In addition, the insights~     gained into the processes underlying different stroke subtypes may lead to more targeted~     diagnostic tools.~   "
59780|NCT02274714|"~     This case-control study will screen for dysmenorrhea and assess severity of menstrual~     symptoms in menstruating women with CD and UC compared with healthy age-matched controls.~     IBD activity will be characterized using previously validated clinical disease activity~     indices. General and health-related quality of life will be assessed using validated~     measures.~   "
59781|NCT02274701|"~     This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician~     communication in outpatient cancer care. Half of the participants will complete a HNA prior~     to their clinical consultation. They will then take it into the consultation and it will~     inform a discussion around any identified areas of need. Half of the participants will be in~     the control group meaning there will be no additional intervention they will receive care as~     normal. The consultations will be audio-recorded. The patient will complete two outcome~     measures following the consultation.~   "
59782|NCT02274688|"~     The nation's trauma care system, which includes trauma center hospitals & emergency~     departments, is where over 30 million Americans receive care after traumatic injuries each~     year. Injury victims are diverse patients who suffer from complications of the initial~     injury as well as from multiple complex medical & mental health conditions. Currently,~     high-quality patient-centered care is not the standard of care throughout US trauma care~     systems. Injured trauma survivors treated in trauma care systems frequently receive~     fragmented care that is not coordinated across hospital, emergency department, outpatient, &~     community settings. Post-injury care is frequently not individualized to integrate the~     patient's most pressing post-traumatic concerns & preferences into medical decision making.~     The investigators, as a group of front-line trauma center providers, patients, researchers &~     policy makers, have been working together for over a decade to integrate patient-centered~     care into US trauma care systems. The investigators began this work by asking groups of~     injured patients the key patient-centered question: Of everything that has happened to you~     since your injury, what concerns you the most? The investigators developed scientifically~     sound assessment tools that allowed us to follow patient concerns after injury~     hospitalization. In May of 2011, the investigators convened an American College of Surgeons'~     policy summit that addressed mental health & patient-centered care integration across US~     trauma care systems. As part of this policy summit, patient members of our team presented~     their experiences of traumatic injury & recovery. While giving injured patients a voice at~     the summit, these narratives did not move surgical policy makers to develop mandates or~     guidelines for patient-centered care. In contrast, presentations that included information~     from randomized comparative effectiveness trials & standardized outcome assessments~     convinced surgical policy makers to develop US trauma care system policy mandates & best~     practice guidelines for post-traumatic stress disorder & alcohol use problems. Our team now~     realizes that in order to optimally integrate patient-centered care into US trauma care~     systems, the investigators must use the best scientific methods that capture the~     highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care~     management treatment that addresses patient's post-injury concerns & integrates patient~     concerns & preferences into medical decision making, while also coordinating care, can~     improve outcomes of great importance to patients & their caregivers, front-line providers &~     policy makers. This proposal directly addresses two PCORI patient-centered research~     questions: After a traumatic injury, what can I do to improve the outcomes that are most~     important to me? & How can front-line providers working in trauma care systems help me~     make the best decisions about my post-injury health & health care?~   "
59783|NCT02274675|"~     A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of~     including robotic therapy into the daily rehabilitation program.~   "
59784|NCT02274662|"~     The primary purpose is to provide access of thymus tissue transplantation to patients who~     have immunodeficiency, hematologic malignancies, or severe autoimmune disease related to~     poor thymic function. With no thymus function, bone marrow stem cells do not develop into T~     cells, which fight infection.~      Eligible participants undergo thymus transplantation and biopsy. Immune suppression may be~     given depending on the immune status and clinical condition of the participant. Immune~     function testing is continued for one year post-transplantation.~   "
59785|NCT02274649|"~     The research will examine the effects of enhanced peer mentor interactions on facilitating a~     successful transition to community living following traumatic spinal cord injury.~     Participants in the research will be assigned to either (1) the control group that will~     receive traditional peer mentor types of interactions or (2) to the intervention group that~     will receive an enhanced peer mentor program called the One-on-One Initiative. Assignment to~     one of these two groups will occur randomly on admission to Shepherd Center; the only~     stratifying criteria is injury level - C6 and above vs. C7 and below.~   "
59787|NCT02274623|"~     This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases~     arising from either breast or prostate cancer, who are taking anti-resorptive therapy.~   "
59790|NCT02274584|"~     Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster~     of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin~     lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive~     target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will~     evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism~     (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.~   "
59791|NCT02274571|"~     The purpose of this study is to find out if a novel drug approved by the Food and Drug~     Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal~     dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by~     decreasing body fat especially in your liver.~      DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a~     mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is~     FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help~     manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of~     postmenopausal women, the use of estrogens alone can increase the risk of developing cancer~     of the uterus. So estrogens have been traditionally paired with a progestin to decrease the~     risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor~     to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in~     place of a progestin to help protect the uterus against thickening of the uterus that may~     result from estrogens alone.~      In this study, you will get either DUAVEE™ or the placebo (a dummy pill that may look like~     medicine but contains no active medication) first and then switch to the other pill.~   "
59792|NCT02274558|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854~     administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.~   "
59793|NCT02274545|"~     H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China~     that affected many older adults. This study will evaluate the safety of and immune response~     to a live attenuated H7N9 vaccine in adults 50 to 70 years old.~   "
59794|NCT02274532|"~     A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a~     prosthetic terminal device will enhance the performance of people with limb loss in a wider~     range of daily living tasks than allowed by today's commercially available prosthetic hands,~     and will exceed established benchmarks for activities of daily living (ADL).~   "
59795|NCT02274519|"~     Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of~     movements with meditation, improve quality of life in those afflicted with multiple myeloma~     undergoing autologous stem cell transplantation?~   "
59796|NCT02274506|"~     The goal of this clinical research study is to learn if researchers can successfully and~     safely give patients who have had a stem cell transplant an infusion of white blood cells~     (called T-cells) that have been collected from an unrelated person, and that have been~     genetically changed. The process of changing the DNA (genetic material) of these T-cells is~     called gene transfer. The gene transfer involves drawing blood from an unrelated donor,~     separating out T cells using a machine, changing the cells' DNA in the laboratory, and~     returning the genetically changed cells back to the body. T-cells are a type of white blood~     cell that fight infection. The type of gene transfer being used in this study is designed to~     help your T-cells to better fight cancer by targeting a chemical marker that is found on~     certain cancer cells.~      Researchers want to learn if these genetically-changed T-cells can help to control B-cell~     leukemia or lymphoma after a stem cell transplant.~      Researchers want to find out the highest tolerable dose of these T-cells that can be given~     to patients with relapsed leukemia or lymphoma.~   "
59797|NCT02274493|"~     The goal of this clinical research study is to learn more about the safety and feasibility~     of using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus~     dorsi muscle for reconstructive procedures.~   "
59798|NCT02274480|"~     The goal of this study is to see if a special type of heart scan called a diffusion weighted~     magnetic resonance imaging (DW-MRI) that uses extra measurements, can be used to find early~     signs of heart damage from chemotherapy.~   "
59799|NCT02274467|"~     Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness~     and safety. Despite its very high success rate, the epidural technique remains a rather~     blind technique and failures continue to occur. The correct placement of an epidural~     catheter, however, remains a clinical problem, since there is no imaging technique that~     could be used at the bedside to determine the exact positioning of the catheter. The~     technique of a trans-catheter electric stimulation test (TCEST) has been successfully used~     to detect the proper epidural catheter location for pediatric, post-operative and laboring~     obstetric patients. The response to the TCEST with the uniport (single hole) epidural~     catheters has been well described. There is a growing body of evidence that multiport~     epidural catheters provide an advantage to uniport catheters, since additional ports likely~     allow for an enhanced distribution of the local anesthetic solution. This was shown to~     result in a lower incidence of inadequate analgesia, including unilateral sensory blockade~     and missed sensory segments. The characteristics of the TCEST response using a multiport~     catheter remain to be determined. The aim of this study is to compare the response patterns~     to the TCEST using a single port versus multiport wire reinforced epidural catheters. The~     hypothesis of this study is that the incidence of a bilateral response to the TCEST will be~     higher in the multiport catheter as compared to the uniport catheter.~   "
59809|NCT02274337|"~     AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR)~     mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small~     cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular~     mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively~     suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal~     transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last~     block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate~     Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress~     the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient~     suppress the EGFR T790M drug-resistant mutation tumor cell.~   "
81596|NCT01989403|"~     The investigators report management of lumbar disc herniation with severe sciatic pain using~     an integrative complementary and alternative medicine approach with a 5 year follow-up.~   "
59800|NCT02274454|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent~     used in the prevention and treatment of PPH is oxytocin, which acts by binding with the~     oxytocin receptor (OTR) found on myometrial cells to cause uterine contraction. It does this~     by increasing levels of calcium within the myometrial cell, which promotes contraction.~     Women who require augmentation of labor with intravenous oxytocin because of inadequate~     labor progression have been shown to be at increased risk of PPH. In-vitro human myometrial~     models have shown that following prolonged exposure to oxytocin there is desensitization of~     the myometrium resulting in a significant reduction in contractility upon delivery of~     further oxytocin.~      Optimal levels of calcium are very important for contraction of the uterine muscle. Too~     little calcium results in a reduced contraction. Too much calcium may result in either~     stronger contractions, or even possibly relaxation of the muscle and therefore a reduced~     contraction. The investigators currently do not know the effects of calcium on the~     desensitized uterine muscle.~      The investigators hypothesize that myometrial contractility following desensitization of the~     myometrium would be reduced in myometrial samples exposed to low calcium, when compared to~     normal calcium or high calcium exposure. These results will help in establishing whether~     myometrial contraction can be augmented by increasing calcium levels within the body, or by~     optimizing normal physiological calcium levels, in the setting of a augmented prolonged~     labor, which is at higher risk of poor uterine contraction and PPH.~   "
59801|NCT02274441|"~     There is no large-scale data in France or internationally, on the quality of care in~     gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or~     on determinants of these delays or misdiagnosis. The creation of a sentinel network for~     gynecological emergencies could help quantify these links and test strategies to avoid the~     worst effects by implementing simple diagnostic tools from clinical research.~      The network will be designed to promote research in women's health and the emergency~     reception by focusing on:~      (i) Assessment of the quality and organization of care and professional practice for the~     management of gynecological emergencies.~      (ii) The study of severe morbidity and its determinants (iii) comparison of organizational~     practices and health outcomes of women over time within the same department or between~     services having substantially the same recruitment (iv) Comparison of organization systems~     gynecological emergencies departement between different high resource francophone countries~     (France, Switzerland, Belgium).~      (v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic~     derived from clinical research.~   "
59802|NCT02274428|"~     Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical~     cord blood derived mesenchymal stem cells) in the premature infants with intraventricular~     hemorrhage (IVH, grade 3-4)~   "
59803|NCT02274415|"~     Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle~     cells disease.~      The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic~     in these patients. We want to evaluate whether a prime with a 13-valent pneumococcal~     conjugate vaccine (PCV), able to induce immunologic memory, would improve the immune~     response against SP polysaccharides (SPP).~      Primary objective: To evaluate and compare the specific antibody response to a prime-boost~     vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at~     W4, to the administration of PSV alone at W4 in patients with sickle cells disease.~      Secondary objectives: Evaluation and comparison of the specific antibody response to the~     thirteen pneumococcal serotypes shared by the PCV and PSV vaccines, 4 weeks after the single~     PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for~     patients from group 2. Evaluation of the duration of the specific antibody response at W24~     and 96. Evaluation of the T CD4 lymphocyte response to the CRM 197 protein. Safety of the~     vaccines.~      Study Design: Randomised, monocentric, controlled phase II study of the immunological~     efficacy of a prime boost strategy combining the sequential administration of the PCV and~     PSV, compared to the administration of the PSV alone. 180 adults patients with sickle cells~     disease will be included. The primary endpoint : proportion of responders at W8 to at least~     10 of thirteen serotypes. Secondary endpoints : Proportion of responders at W8 according to~     4 categories of responders: 5-7; 3-4; 2-1 and 0. Evaluation of the pneumococcal~     opsonophagocytic activity (OPA) at baseline and W8 for each serotype, defined as the~     proportion of patients with OPA > 1:8 geometric mean of the specific antibody titers~     proportion of patients who experienced an increase of specific antibody levels 1 g/ml.~     Evaluation of the priming effect of the PCV vaccine in the group 1. Duration of the specific~     antibody responses at week 24 and W96. CD4 T lymphocyte responses to the CRM 197 protein~     (proliferative and cytokine production) at weeks 0, 8 and 12. Safety of the vaccines~     frequency of Streptococcus pneumoniae infections.~      Statistical Considerations: With a sample size of 180 patients, and a randomization ration~     of 1:1, the study will have a power of at least 90% to show a difference of 25% category~     between the group receiving PCV and PSV vs the group receiving PSV alone (two-sided type I~     error = 5%). The primary comparison between both groups will be performed using a Chi2 test~     for independent groups or a Fisher exact test where appropriate.~   "
59804|NCT02274402|"~     This is a monocentric study, in the Internal Medicine Service of Cochin Hospital, Paris. Our~     main objective is to determine the pharmacokinetic properties of prednisone, secondary~     objectives are to determine the covariates affecting the prednisone pharmacokinetics and the~     relationship between glucocorticoid exposition levels and their side effects. The~     investigators will use a prospective, observational, population pharmacokinetic approach.~     100 patients starting a prednisone treatment >7,5mg/d for an expected period >3 months will~     be recruited and followed over 6 months.~   "
59805|NCT02274389|"~     The purpose of this study is to describe the medical indication and utilization of expert~     medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility~     based on minimum inhibitory concentrations (MICs) reported for baseline and subsequent~     isolates, BDQ drug utilization data to include dose, duration, past treatment history, past~     medical history, concomitant medications, and health care site of treatment, drug~     distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and~     microbiologic) and adverse events among BDQ-treated participants, including deaths.~   "
59806|NCT02274376|"~     This observational study will collect prospective data on the safety and tolerability of~     Xeloda in patients with advanced gastric cancer from every day clinical practice.~     Documentation of treatment for each patient is to continue until the end of treatment per~     oncologist's assessment.~   "
59807|NCT02274363|"~     The purpose of this study is to assess the severity of plaque‐type psoriasis (common~     genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp,~     genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with~     chronic plaque-type psoriasis.~   "
59808|NCT02274350|"~     The aim of this study is:~        -  To investigate which sexual side effects occur after external beam radiation therapy~          and brachie therapy~        -  To investigate how many patients are affected~        -  To investigate if there is a time dependency for the severity of the sexual side~          effects~        -  To investigate if there is a dose dependency for the severity of the sexual side~          effects~        -  To find predicting and associated factors for the discovered sexual side effects to~          help identifying patients at risk~   "
59810|NCT02274324|"~     To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in~     patients with PD treated with Duodopa®. This is in search for an optimal diet that will~     accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and~     thus improve motor function and quality of life.~   "
59811|NCT02274311|"~     To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and~     testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy~     and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone~     receptor antagonist)~   "
59812|NCT02274298|"~     This pragmatic cluster randomized controlled trial will test the impact of feedback and a~     toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary~     care setting. This trial will use family physicians in Ontario participating in the~     Electronic.~   "
59813|NCT02274285|"~     Primary objective:~        -  To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP),~          Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3~          antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B:~          DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary~          vaccination (all antigens).~      Secondary objectives:~        -  To describe immune responses against all vaccine antigens with no pre-specified~          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose~          4) in the two study groups (Group A and Group B).~        -  To describe the safety after each dose of each vaccine in the two study groups (Group A~          and Group B).~        -  To describe immune responses against all vaccine antigens with no pre-specified~          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4~          (Group C)~   "
59814|NCT02274272|"~     The purpose of this study is to evaluate the efficacy and safety of probiotics~     ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for~     the treatment of adults with type2 DM.~   "
59815|NCT02274259|"~     Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number~     of needed injections over a 18 month period in patients with newly diagnosed CRVO.~   "
59816|NCT02274246|"~     The purpose of this study is to validate the technique for the detection of left atrial~     fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained~     with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of~     healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.~   "
59817|NCT02274233|"~     The purpose of this study is to assess safety and amount of the study drug in the blood~     after increasing doses of SP-420. The study will be conducted in patients with~     β-thalassemia.~   "
59818|NCT02274220|"~     The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the~     relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by~     investigating the effects of two different feeding strategies in infants following cardiac~     surgery. The study's primary objective is to determine if early and higher volume feeding~     modifies the relationship between the severity of postoperative systemic inflammation and~     insulin resistance.~   "
59819|NCT02274207|"~     The purpose of this study is to test therapeutic benefits of silver dressing compared with~     non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may~     antibacterial effect on infected diabetes mellitus foot.~   "
59820|NCT02274194|"~     The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous~     positive airway pressure (CPAP) is the chosen treatment in moderate and severe OSA. However,~     the adherence to CPAP varies, and the interface between patient and the CPAP may interfere~     with adherence, comfort and efficiency. Objectives: (1) to determine which is the preferred~     airway flow in oral and nasal breathers, (2) to analyze the role of body position on the~     nasal mucosa and the airways after one night CPAP titration, (3) the effects of nasal and~     oronasal CPAP on the nasal epithelium and airways, inflammation in nasal lavage and miRNA~     changes in blood and (4) CPAP adherence after 12 months. Population: 20 patients with~     moderate/severe OSA recruited at Sleep Laboratory of Heart Institute - Hospital das Clínicas~     da Faculdade de Medicina da Universidade de São Paulo.~   "
59821|NCT02274181|"~     The purpose of this study is to investigate the route(s) of elimination and mass balance of~     enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~])~     500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.~   "
59822|NCT02274168|"~     With the increasing use of implantable cardioverter defibrillators (ICD) for primary~     prevention in patients with structural heart disease, an increasing number of patients are~     expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an~     ICD is in place and the only documentation of the clinical arrhythmia will be the ICD~     electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained~     monomorphic VT represents a limitation when performing treatment with radiofrequency (RF)~     ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a~     reference model of VT with clinical expression consisting of the electrical signal of the~     ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This~     will allow for a more targeted approach to the substrate of the VT with clinical expression~     because: 1) if VT is induced by programmed stimulation, one can tell whether it is with~     clinical expression or not, and 2) if VT is not induced, ventricular pacing could be~     performed based on the comparative analysis of morphology and activation times of ICD-EG.~     These approaches will result in improved outcomes of the ablation procedure.~   "
59823|NCT02274155|"~     The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given~     prior to surgery in patients with advanced head and neck squamous cell carcinoma.~   "
59824|NCT02274142|"~     The aim of this protocol is to evaluate the cost-efficacy of different glass ionomer cements~     in Atraumatic Restorative Treatment restorations, with different handling characteristics:~     powder-liquid versus encapsulated.~   "
59825|NCT02274129|"~     This study investigates the use of a new healing cap which, through altered design and~     choice of material, has been improved when it comes to minimizing the risk of it falling off~     as well as increasing patient comfort.~   "
65551|NCT02199327|"~     The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and~     topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial~     neoplasia.~   "
59826|NCT02274116|"~     The purpose of this study is to determine how the nervous system controlling leg muscles is~     altered following spinal cord injury and how they may be affected by brief periods of low~     oxygen inhalation over time.~      The investigators hypothesize:~        -  Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength~          in persons with incomplete cervical spinal cord injury (SCI)~        -  AIH exposure will increase multijoint reflex excitability of leg muscles in persons~          with incomplete cervical SCI~        -  AIH exposure will increase walking performance in persons with incomplete cervical SCI~   "
59827|NCT02274103|"~     Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with~     poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM.~     Examined the differential impact on the youth's adherence to the diabetes medical regimen~     and the youth's blood sugar control.~   "
59828|NCT02274090|"~     This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe~     periodontitis subject.~   "
59829|NCT02274077|"~     The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal~     wall reconstruction population using an intraoperative local anesthetic infusion. A~     prospective randomized double blind study of patients undergoing component separation will~     be performed in order to assess the following outcomes:~        1. Length of Stay (LOS)~        2. Return of bowel function~        3. Narcotic pain medication requirements~        4. Nausea and emesis~        5. Pain scores~   "
59830|NCT02274064|"~     This study develops a motivational interview and implementation intention intervention for~     blood donor retention and tests the efficacy of this new approach among first-time, Group O~     donors.~   "
59831|NCT02274051|"~     This is a study of kinetin, a nutritional supplement that corrects the mRNA splicing defect~     in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary~     sensory and autonomic neuropathy type III). FD is a rare fatal autosomal recessive disease~     in which the growth and development of selective neuronal populations is impaired. The~     disease is the result of a point mutation in the gene sequence that encodes for kinase~     complex associated protein (IKAP) in chromosome 9q31. The mutation, at the start of the~     non-encoding intron 20, weakens the splice site, causing the spliceosome to wrongly join~     together exons 19 and 21 when transcribing the mRNA strand and miss out exon 20. The mutated~     mRNA produces a short unstable IKAP protein that is quickly degraded. Interestingly, the~     mutation does not lead to a complete loss of function. Instead, it results in a tissue~     specific deficiency in splicing efficiency with both normal (wild type) and mutant IKAP mRNA~     being expressed in different ratios in different tissues. Some cells, like fibroblasts,~     produce mostly normal mRNA and protein, where as others, like neurons, produce mostly mutant~     mRNA and almost no functional protein product.~   "
59832|NCT02274038|"~     The investigators will test the hypothesis that positron emission tomography (PET) imaging~     with the imaging agent 18F-thymidine (FLT) can rapidly assess treatment response in patients~     with unresectable non-small cell lung cancer (NSCLC).~   "
59833|NCT02274025|"~     NovellusDx technology identifies tumor-specific driver mutations, but unlike~     sequencing-based tests, NovellusDx has a functional assay that detects dis-regulated~     translocation of mutated signaling proteins to the nucleus. This allows NovellusDx to~     identify functionally-impactful driver mutations regardless of whether the mutation has~     previously been described or linked to a tumor type.~   "
59834|NCT02274012|"~     The investigators are doing this research program to find out if the investigational drug,~     afatinib which is a medication known to block the function of the ErbB2 protein might help~     standard chemotherapy, in particular paclitaxel, work better.~      Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July~     12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the~     first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had~     specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution~     mutations) as detected by an FDA approved test.~      Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and~     Drug Administration (FDA) for the treatment of lung cancer.~      The combination of Afatinib and Paclitaxel are considered investigational when used in this~     research program. An investigational drug is a drug that is not approved by the FDA for its~     indication.~   "
59835|NCT02273999|"~     This randomized clinical trial was designed to assess the clinical efficacy of Pulsed~     electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain~     and quality of healing after mandibular third molar extraction.~      The sample included 120 patients undergoing unilateral mandibular third molar extraction.~     The devices were positioned over the area corresponding to the extraction site and wearers~     were asked to keep them in place for 7 days. All patients were asked to record pain (on a~     visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of~     analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local~     lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded~     blindly.~   "
59836|NCT02273986|"~     The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of~     digoxin in healthy adult volunteers.~   "
59837|NCT02273973|"~     This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate~     the effect of combining letrozole and GDC-0032 versus letrozole and placebo in~     postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor~     receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be~     randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at~     2.5 mg will be dosed once daily plus either GDC-0032 at 4 mg (two 2-mg tablets) or placebo~     on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.~   "
59838|NCT02273960|"~     The purpose of this study is to assess the safety and tolerability of BMS-986004 when~     administered in subjects with ITP.~   "
59839|NCT02273947|"~     The purpose of this study is to assess the impact of a light meal, a standard meal, and a~     high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted~     conditions.~   "
59840|NCT02273934|"~     The purpose of this study is to determine whether a special kind of rehabilitation offered~     to home-dwelling adults is effective with regards to functional ability, health-related~     quality of life, coping, mental health and municipal costs.~   "
65552|NCT02199314|"~     Test the hypothesis to recruit larger motor responses to transcranial stimulation.~   "
59841|NCT02273921|"~     The goal of this study is to construct a large database of EEG recordings from elderly~     individuals in predefined groups. The purpose of this database is to select groups of EEG~     recordings from the database in order to compare the electrophysiology, as measured by EEG,~     of the groups.~      In the clinical trial part all individuals are treated exactly the same and are therefore~     considered a single group. The categorization is performed during the data analysis.~      The groups in the data analysis will initially be based on the following:~        1. Healthy controls~        2. Mild Cognitive Impairment~        3. Alzheimers Disease (AD)~        4. Lewy-body Dementia~        5. Parkinsons Disease Dementia~        6. Vascular Dementia (VaD)~        7. Frontotemporal Dementia (FTD)~        8. Depression~      Other groups will be added if needed.~   "
59842|NCT02273908|"~     The purpose of this study is to evaluate the effect of pregabalin comparing with the~     conventional analgesic care in chronic low back pain patients with accompanying lower limb~     pain (neuropathic component) treated in primary care settings under routine clinical~     practice.~   "
59843|NCT02273895|"~     The objective of this study is to compare the electroencephalography (EEG) responses of~     three distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD)~     patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a~     group of controls. The main purpose of this comparison is to discover ways to use these~     responses to distinguish between the group of AD patients and controls in order to develop a~     diagnostic tool for AD. The purpose of including the MCI group is to investigate whether~     this diagnostic tool can predict which member of the MCI group will develop AD later in~     life.~   "
59844|NCT02273882|"~     Purpose of this study is to evaluate clinical, humanistic and health economic burden of~     Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA)~     hospitalized for RSV at up to 12 months of age.~   "
59845|NCT02273869|"~     Our infertility unit has started a clinic for women with rheumatological diseases. those~     women are prone to infertility problems and it might be due to their illness or cytotoxic~     treatment . In our study we are going to observe the effect of their disease on ovarian~     reserve. we will assess it by using intravaginal sonography and blood test such as hormonal~     profile and anti-mullerian hormone (AMH).~   "
59846|NCT02273856|"~     The purpose of this study is to document the pharmacological treatment strategies used in~     treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle~     East and North African (MENA) region. This study will also record encountered tumor subtype~     and stage and the instituted pharmacological treatments, as well as assess the clinical~     outcomes of treatments.~   "
59847|NCT02273843|"~     This is a randomized controlled trial (RCT) to evaluate the influence of different doses of~     vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and~     C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to~     assess its influence on clinical outcomes of these infants.~   "
59848|NCT02273830|"~     The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD~     patients without conventional for LTOT but with exercise desaturation.~   "
59849|NCT02273817|"~     This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of~     the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and~     to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with~     Omnaris™ nasal spray.~   "
59850|NCT02273804|"~     The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body~     Mass Index compared to placebo at 9 months.~   "
59851|NCT02273791|"~     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation~     prior to frozen-thawed embryo transfer (FET) in patients with polycystic ovarian syndrome~     (PCOS)~   "
59852|NCT02273778|"~     Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for~     cure while preserving patients' quality of life including their ability to speak and~     swallow. In order to reduce the potentially major side effects of treatment, it is essential~     that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At~     present a computerized tomography (CT) scan is used by the cancer specialist to identify the~     tumour for planning the radiotherapy treatment. The investigators know that other types of~     scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans~     are better than CT scans at showing areas involved by the cancer. However, radiotherapy~     cannot be directly planned on these types of scans. The aim of this study is to explore~     whether PET and MRI scans can be combined with CT scans to more accurately identify the~     tumour target. In addition, this study will explore whether PETCT and MRI scans may used to~     adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. If~     the radiotherapy planning process can be improved in these ways, the investigators hope~     future patients will benefit by more chance of cure with a reduction in the side effects of~     treatment. The study aims to recruit 16 patients. All patients within the study will undergo~     a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of 8~     patients will undergo additional imaging at two timepoints during the course of their~     radiotherapy. The study is noninterventional and patients' standard treatment will not be~     affected by their participation in the study.~   "
59853|NCT02273765|"~     Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral~     treatment of HIV-infected patients with tuberculosis.~   "
59854|NCT02273752|"~     This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring~     works in preventing stomatitis from developing in patients with hormone receptor positive~     breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type~     of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that~     causes inflammation of the mouth, with or without oral ulcers, and frequently leads to~     patients discontinuing the medication. Monitoring the blood levels of everolimus and making~     adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while~     maintaining the effectiveness of everolimus to treat the cancer.~   "
59978|NCT02272140|"~     The objective of this study is to evaluate the utility of localized stimulation of the~     lumbosacral nerve roots during XLIF through correlation of observed changes in the response~     latency, amplitude, waveform morphology, and/or response threshold with surgical events.~     Additionally, correlation between neuromonitoring findings and postoperative neural status~     will be evaluated.~   "
59855|NCT02273739|"~     The purpose of this Phase 1/2, multi-center study is to evaluate the safety,~     pharmacokinetics, pharmacodynamics and clinical activity of AG-221 in subjects with advanced~     solid tumors, including glioma, and with angioimmunoblastic T-cell lymphoma (AITL), with an~     IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of~     patients will receive ascending oral doses of AG-221 to determine maximum tolerated dose~     (MTD) and/or the recommended Phase 2 dose. The second portion of the study is a planned dose~     expansion phase where three cohorts of patients will receive AG-221 to further evaluate the~     safety, tolerability, and clinical activity. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
59856|NCT02273726|"~     The purpose of this study is to determine whether roxadustat is effective and safe compared~     to epoetin alfa in the maintenance treatment of anemia in stable hemodialysis and peritoneal~     dialysis subjects when converted from their existing stable erythropoiesis stimulating agent~     treatment.~   "
59857|NCT02273713|"~     Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year~     survival rate of 10% worldwide and patients are often diagnosed with locally advanced or~     metastasized disease at first presentation. For advanced oesophagogastric cancer~     fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or~     3-drug combinations .~      However, in clinical practice after progression on first line therapy, a substantial number~     of oesophagogastric cancer patients may not be able to start second line chemotherapy due to~     rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low~     toxicity are urgently needed.~      Given the activity of capecitabine and oxaliplatin containing regimens and the potential of~     taxanes in oesophagogastric cancer, the investigators propose a phase I study combining~     capecitabine and oxaliplatin with Nab-paclitaxel.~      Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the~     active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a~     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require~     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated~     hypersensitivity reactions. This new formulation improves safety profile, allows higher~     dosing with shorter infusion duration, and produces higher tumor drug concentration. It has~     proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in~     gastric cancer models.~   "
59858|NCT02273700|"~     The main objective of this pilot study is to investigate the protein / peptide plasma~     profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients~     with non-valvular atrial fibrillation to better understand the mechanisms of action of these~     molecules and perform exploratory analyses concerning proteins whose concentrations change~     after starting treatment.~   "
59859|NCT02273687|"~     The main objective of this study is to show that diaphragmatic excursion measures upon~     emergency admission (CDA values) on patients with acute respiratory failure are predictive~     of the need to use mechanical ventilation (invasive or non-) in the first four hours.~   "
59860|NCT02273674|"~     The purpose of this study is to determine the potential effects of repetitive transcranial~     magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in~     borderline personality disorder patients. Specially in cognitive flexibility, inhibition~     control and social cognition.~   "
59861|NCT02273661|"~     Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a~     strategy with a maintenance treatment and a conventional strategy without antifungal~     maintenance therapy.~   "
59862|NCT02273648|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and~     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in an all-comers patient population in daily clinical practice.~   "
59863|NCT02273635|"~     The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg~     administered twice a day orally versus a placebo as a modifying treatment of the disease in~     patients with the progressive forms of Multiple Sclerosis (MS).~      The principal outcome is to determine the efficacy, of andrographolide in retarding the~     progression of brain atrophy in patients with progressive forms of MS.~   "
59864|NCT02273622|"~     Explore the detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme~     expression (leading to xenobiotics detoxification in the liver).~   "
59865|NCT02273609|"~     The primary objective of this study was to determine rates of INR control of patients with~     nonvalvular AF daily attended in primary care in Spain.~      PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged~     ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care~     were included in the study. To be included, at least 80% of INR values during the past 12~     months should be available. Before inclusion, patients provided written consent.~      Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding~     risk) were recorded from the clinical history of patients at the moment of inclusion. INR~     values were taken from the previous 12 months of inclusion.~      Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65%~     (calculated by Rosendaal method) or <60% by direct method (proportion of INR values).~      A total of 1,524 patients have been included in the study.~   "
60302|NCT02267889|"~     This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the~     treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP~     will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac~     camera will guide the GP ablation procedure.~   "
59866|NCT02273596|"~     The purpose of the study is to evaluate the efficacy and safety of WTX101 administered for~     24 weeks in newly diagnosed Wilson Disease (WD) patients aged 18 and older with~     Nonceruloplasmin-bound copper (NCC) levels within or above the normal reference range at the~     time of enrollment. Subjects with Wilson Disease who have received either no prior Wilson~     Disease treatments, or have been treated for up to and including 24 months prior to study~     enrollment with chelation therapy (e.g. trientine, penicillamine), zinc therapy or~     combination therapy are eligible to participate, if all other inclusion and no exclusion~     criteria are met. The purpose of the 12 month Extension Phase is to evaluate the durability,~     and establish long-term safety and efficacy of WTX101.~   "
59867|NCT02273583|"~     Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective~     against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of~     maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with~     high grade, operable, non-metastatic osteosarcoma (OST) of the extremities. The primary end~     point is event-free survival (EFS) from randomization.~   "
59868|NCT02273570|"~     Clinical study aimed at improving anemia management in End Stage Renal Disease Patient~     (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone~     Disorder (CKD-MBD)~   "
59869|NCT02273557|"~     The objective of this study was to compare the pharmacokinetics of dipyridamole in three~     different Asasantin ER batches (test) containing different amounts of retarding lacquers to~     the existing commercial product at steady state with BID treatment~   "
59870|NCT02273544|"~     The objective of this study was to compare the pharmacokinetics of dipyridamole in three~     different Asasantin ER batches (test) containing different amounts of retarding lacquers to~     the existing commercial product at steady state with b.i.d. treatment~   "
59871|NCT02273531|"~     Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the~     present commercially available Asasantin ER formulation (Aggrenox®)~   "
59872|NCT02273518|"~     Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER~     compared to the present commercial formulation~   "
59873|NCT02273505|"~     Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release~     Persantin tablets combined with Acetyl salicylic acid (ASA) tablets~   "
59874|NCT02273492|"~     Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state~   "
59875|NCT02273479|"~     Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in~     multiple administration to healthy adult male volunteers.~   "
59876|NCT02273466|"~     To assess the steady state pharmacokinetics of Desipramine with/without concomitant~     administration of Crobenetine.~   "
59877|NCT02273453|"~     Study to determine the presence of a hang-over effect in healthy volunteers the day after~     the administration of Songha® Night~   "
59878|NCT02273440|"~     To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single~     dose of theophylline.~   "
59879|NCT02273427|"~     food effect, relative bioavailability, pharmacokinetics, safety and tolerability~   "
59880|NCT02273414|"~     The objective of the present study is to obtain information about the safety and~     tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose~     range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary~     pharmacokinetic data concerning steady state and accumulation factor~   "
59881|NCT02273401|"~     To investigate safety, tolerability, and pharmacokinetics of BI 11054~   "
59882|NCT02273388|"~     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI~     6727 therapy in terms of drug-related adverse events. Secondary objectives are the~     collection of overall safety and antitumour efficacy data and the determination of the~     pharmacokinetic profile of BI 6727.~   "
59883|NCT02273375|"~     The purpose of this study is to find out whether it is better to receive a new drug,~     MEDI4736, or better to receive no further treatment after surgery (and possibly~     chemotherapy) for lung cancer.~   "
59884|NCT02273362|"~     This pilot clinical trial studies the best dose of erlotinib hydrochloride and to see how~     well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver~     undergoing surgery. Erlotinib hydrochloride may help to inhibit the development of fibrous~     tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.~   "
59885|NCT02273349|"~     The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung~     Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused~     emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue~     destruction profile was well as symptoms and thus will respond favorably to LVRC treatment,~     demonstrating improvement in lung function, exercise capacity, and quality of life relative~     to their baseline status.~   "
59886|NCT02273336|"~     This research trial studies genomic analysis in tissue and blood samples from young patients~     with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid~     [DNA]) may help doctors tailor treatment to target the specific mutations and help plan~     effective treatment.~   "
59887|NCT02273323|"~     Research indicate that people who regularly drink tea have a reduced risk of stroke or heart~     disease. In a number of studies in which people that normally do not drink showed that their~     blood vessels function improved when the drunk tea. The current study tests whether a~     specific black tea improves vessel function in non-tea drinking hypertensive subjects.~   "
59888|NCT02273310|"~     This study aims to develop an effective, brief, family-based intervention targeting quality~     of life and school functioning for youth with sickle cell disease. Utilizing a randomized,~     delayed control group intervention methodology, the present study will systematically~     document the effectiveness of a family-based, one-day intervention plus booster phone calls~     to improve quality of life and increase school functioning for children with sickle cell~     disease transitioning to school and their families.~   "
59889|NCT02273297|"~     The purpose of this study is to establish and follow longitudinally a cohort of ethnically~     diverse pregnant women and their offspring, in order to explore the hypothesis that fetal~     over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in~     the offspring.~   "
59890|NCT02273284|"~     The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children~     and youth who suffer from stiffness of their muscles due to a neurological problem. These~     injections are given into each muscles which require treatment, which often means receiving~     multiple injections in one session. Intramuscular injections are typically painful.~     Treatment can be provided unsedated and then should incorporate distraction and relaxation~     techniques, or can be alternatively be provided with the use of sedation.~      To improve the pain experience the investigators want to assess the feasibility and impact~     on the pain perception when using a vibration device called the Buzzy during BoNT-A~     injections. The Buzzy creates a vibration that is applied over the injection site for 30~     seconds before the injection and will be continued just above the injection site during the~     injection. The Buzzy has been shown to help reduce pain in procedures such as i.v.~     insertions and immunizations, but has not been tested in children and youth receiving~     multiple BoNT-A injections.~   "
59891|NCT02273271|"~     The purpose of the study is to qualify, independently, tumor cell proliferation by~     3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by~     Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological~     quantification (% of viable tumor cells) of the primary tumor after pre-operative~     chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).~   "
59892|NCT02273258|"~     Primary Objective:~      To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.~      Secondary Objective:~      To assess the safety and tolerability of SAR342434.~   "
59893|NCT02273245|"~     Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest~     pain. There are several possible underlying causes, which cannot be distinguished from one~     another at the bedside.~      Current practice is to image this with two CT scans of the chest, one before injection of a~     contrast dye into the blood stream and then one after.~      With the advancement of CT scanner technology, improvements in software interpretation and~     screen resolution, the investigators hypothesise that performing the contrast scan on its~     own is diagnostically equivalent to both the pre- and contrast scans~   "
59894|NCT02273232|"~     Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic~     patients in which exposing the limbs for periods of short intermittent ischemia produces~     protective effect on heart muscle. The concept was applied to many other parts of the body~     and the results are positive so far.~      No human trials on this concept has been conducted in patients with peripheral vascular~     disease so far but applying the concept for healthy individuals shows vessels dilatation and~     animal trials shows degree of new vessels formation in addition to reports of symptoms~     improvement.~      The trial candidates will be allocated blindly in 4 groups. All groups will have advice~     about exercise which is the standard practice now. The first group will have supervised~     exercise. The second group will in addition to the supervised exercise get the ischemic~     preconditioning with the blood pressure cuff. The third group will get the ischemic~     preconditioning and the fourth group will get the standard exercise advice. All candidates~     will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of~     the trial and again at the end.~      The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms,~     new vessel formation and other parameters will be recorded~   "
59895|NCT02273219|"~     Primary objective is to define the maximum tolerated dose (MTD) for the combination of~     AEB071 and BYL719. Secondary objectives are to define the safety and tolerability of AEB071~     and BYL719.~   "
59896|NCT02273206|"~     Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost~     entirely Latino or African American. Cancer is the leading cause of premature death in the~     Bronx, with morality rates significantly higher than for New York City as a whole.~     Low-income/minority populations are more likely to be diagnosed with preventable and~     late-stage cancers than the general population, in part, due to lower screening rates. While~     research has addressed screening barriers in low-income/minority groups, depression, a~     common,potentially critical barrier, has received scant attention. Research suggests that~     depressed women are less likely to engage in cancer screening, especially mammography and~     Pap testing. The link between mental health and cancer screening is particularly important~     to address in the Bronx, which has the highest rates of self-reported serious psychological~     distress (a measure closely related to depression) in New York City. Depression affects~     almost 1 in 4 minority women, and while minorities often seek help for depression in primary~     care, primary care depression management often does not meet evidence-based standards.~     Drawing on the expertise and close collaboration of Bronx medical and social service~     providers and patient stakeholders, this study will determine whether a collaborative care~     intervention that addresses both depression and cancer screening needs simultaneously among~     women ages 50-64 is more effective at improving cancer screening and patient-reported~     outcomes for women with depression than an existing evidence-based cancer screening~     intervention alone.~      To achieve this, the investigators will compare the effectiveness of these two interventions~     using a randomized controlled trial (RCT). In partnership with three Bronx Federally~     Qualified Health Centers (FQHCs), the investigators will recruit approximately 756 women~     ages 50-64 who screen positive for depression and are non-adherent with recommended~     cervical, breast, and/or colorectal cancer screenings. The investigators specific aims are~     to: 1) compare the impact of the two interventions on patient-reported outcomes, including~     cancer screening knowledge and attitudes, self-efficacy, depression-related stigma, provider~     referrals, participation in mental health care, medication adherence, quality of life,~     satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness~     of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3)~     determine whether reducing depression increases the likelihood that low-income women 50-64~     will receive cancer screening; 4) determine whether effectiveness of the two interventions~     in increasing cancer screening varies according to patient characteristics, such as duration~     of depression, presence of other chronic conditions, and obesity.~      This study is designed to increase the investigators understanding of how to enhance primary~     care systems' ability to improve a range of outcomes related to cancer screening and~     depression among low-income minority women, and how to best support this population in~     making cancer-screening decisions.~   "
59897|NCT02273193|"~     A prospective cohort research study is being conducted in the Mike O'Callaghan Federal~     Medical Center (MOFMC), Department of Family Medicine, Obstetrics Clinic to determine if~     early screening with hemoglobin A1C, a blood test for blood glucose, can be used to identify~     women with hyperglycemia or Gestational Diabetes Mellitus (GDM) in the first semester of~     pregnancy in place of a fasting blood glucose blood test. This study will also determine how~     hemoglobin A1C compares with the oral glucose tolerance test (GTT) done as a standard of~     care with the standard of care second trimester prenatal care testing. Subjects recruited~     and consented during the Obstetrics Orientation Class will have two (2) additional blood~     tests drawn with their standard of care prenatal tests in the first trimester (<13 weeks) of~     pregnancy and at the second trimester (24-28 weeks) of pregnancy. Subjects identified as~     having GDM by blood HbA1C, fasting glucose or the 2 hr OGTT will be treated for GDM with~     standard of care by their primary care provider. The correlation of blood HbA1C with the~     fasting glucose in the first trimester of pregnancy and with the 2 hr OGTT will be~     determined for early detection and diagnosis of GDM. This study will contribute to~     understanding the role of HbA1C in pregnancy and the development of GDM.~   "
60360|NCT02267135|"~     This study will assess the efficacy and safety of secukinumab compared to placebo in adult~     patients who have moderate to severe scalp psoriasis that is poorly controlled by current~     psoriasis treatments.~   "
59898|NCT02273180|"~     Primary Objective:~      To demonstrate non-inferiority of SAR342434 versus Humalog in HbA1c change in patients with~     type 1 diabetes mellitus (T1DM) also using insulin glargine.~      Secondary Objectives:~      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status~     and antibody titers at baseline and during the course of the study.~      To assess the relationship of anti-insulin antibodies with efficacy and safety including~     during the safety extension.~      To assess the efficacy of SAR342434 and Humalog in terms of proportion of patients reaching~     target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG)~     profiles, and insulin dose.~      To assess safety of SAR342434 and Humalog.~   "
59899|NCT02273167|"~     This study evaluates the efficacy, safety and tolerability of NER1006 compared with MOVIPREP~     in adult patients requiring bowel cleansing prior to any procedure that requires a clean~     bowel, using a 2-Day Split-Dosing and 1-Day Morning Split-Dosing regimens. Approximately 810~     patients will be randomised with the aim of achieving a minimum of 245 patients in each of~     the 3 groups.~   "
59900|NCT02273154|"~     This is a Multicenter, open lable, parallel randomized controlled clinical trial.~      This study aimed to evaluate the treatment onset time, efficacy and safety in patients with~     major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.~   "
59901|NCT02273141|"~     The study evaluates the safety efficacy and tolerability of NER1006 versus a Sodium~     picosulfate and Magnesium salt solution in overall bowel cleansing using a day before only~     dosing regimen in adults. It is anticipated that approximately 484 patients will be~     randomised. Half of the participants will receive NER1006 while the other half will receive~     Sodium picosulfate and magnesium salt.~   "
59902|NCT02273128|"~     Osteoporosis and Periodontitis are multifactorial diseases which share common risk~     factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor~     gene? in patients with Osteoporosis and Periodontitis.~   "
59903|NCT02273115|"~     The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for~     induction of labor will increase the rate of delivery within 24 hours stratified by parity.~   "
59904|NCT02273102|"~     Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients.~     Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases,~     is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid~     (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be~     cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect.~     Consequently, 85% of these patients will succumb to their disease despite conventional~     approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This~     knowledge gap limits the use of ATRA in a disease that already has few effective therapies.~     The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to~     ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators'~     publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP),~     unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA~     and TCP markedly diminished the engraftment of primary human AML cells in murine models,~     indicating that the combination may target leukemia-initiating cells (LIC). The~     investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may~     contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that~     ATRA combined with TCP will be safe and effective in a clinical population, and that this~     approach will suppress LICs and restore myeloid differentiation programs in patients with~     non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this~     protocol, will establish a new treatment paradigm in AML and extend the important~     anti-cancer effects of ATRA to all AML subtypes.~   "
59905|NCT02273089|"~     This study intends to determine whether continuous positive airway pressure (CPAP) can~     reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in~     sleepy patients with obstructive sleep apnea .~   "
59906|NCT02273076|"~     The current surgical procedure for breast diseases places an emphasis on the conservation of~     breast skin in order to provide more optimal reconstruction.~      The purpose of this study is to use portable, non-contact optical imaging device developed~     at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes~     in a skin during reconstructive surgery procedure and healing process.~   "
59907|NCT02273063|"~     The purpose of this study is to see how well a treatment called Repetitive Transcranial~     Magnetic Stimulation works for patients who struggle with symptoms of both posttraumatic~     stress disorder and major depressive disorder.~   "
59908|NCT02273050|"~     A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the~     Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy~     Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2~     Diabetes who have Inadequate Glycaemic Control~   "
59909|NCT02273037|"~     A novel handheld Doppler has been developed which is rugged and is powered only by a hand~     crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the~     fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that~     with its ease of use, both for the woman and midwife, midwives using the Doppler will~     identify more babies in need of prompt delivery and the risk of stillbirth and neonatal~     mortality will decline. In the research study, the investigators will compare the risk of~     stillbirths and neonatal mortality in two randomized groups of labouring women.~      The second part of the study consists of an audit of the documentation in labour by~     midwives. The partograph is an uncomplicated, low cost form on which observations during~     labour are documented. It includes three sections of information: fetal condition, maternal~     condition and labour progress. Although the use of a partograph during labour is strongly~     recommended by the WHO, there are limited published systematic evaluations of the correct~     use of the tool. The investigators aim to use this randomized trial design to assess rates~     of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and~     assess the quality of partographs comparing two groups.~      This trial will provide insights on the potential benefits of using handheld Doppler devices~     for intrapartum monitoring, and the audit of partograph quality will provide insights to~     improve care during labour. This study hypothesizes that the quality of partograph~     completion and of fetal heart rate monitoring may systematically differ between the Doppler~     and Pinard groups.~   "
59910|NCT02273024|"~     The investigators hypothesize that inactivity during the search for a donor may exacerbate~     current deconditioned states; subsequently, influencing risk factors for post-transplant~     complications that hinder the recovery phase.~      This study is designed to investigate if exercise therapy administered prior to allogeneic~     hematologic stem cell transplantation (HSCT) can influence physical and psychological~     side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be~     randomized into either an exercise group or usual care group and followed until one year~     after HSCT.~   "
59911|NCT02273011|"~     Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both~     well-established anesthetic methods for caesarean section. CSEA combines the advantages of~     spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain~     management. The aim of this randomized trial was to compare analgesia and patient~     satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA~     with oral pain medication in the postoperative period.~   "
59912|NCT02272998|"~     This phase II trial studies how well ponatinib hydrochloride works in treating patients with~     cancer that has spread to other parts of the body (metastatic), has failed previous~     treatment (refractory), and has one of several alterations, or mutations, in its~     deoxyribonucleic acid (DNA) sequence. Ponatinib hydrochloride may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether a~     patient's genetic alterations may affect how well ponatinib hydrochloride works.~   "
59913|NCT02272985|"~     The purpose of this study is to evaluate the effect of the hemodialysis procedure on~     cerebral blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The~     investigators hypothesize that HD induced blood pressure changes are associated with a fall~     in global and/or regional CBF during HD. Second, the investigators hypothesize that near~     infrared spectroscopy (NIRS) will correlate with CBF measured by[15O]H2O PET.~   "
59914|NCT02272972|"~     This study consists of a retrospective and a prospective part. For each part and in each of~     5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with~     pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two~     assessments in the retrospective part. a) before an educational intervention, b) after the~     educational intervention. The evaluated images at these two timepoints are identical. In the~     prospective part, the surgeons apply their new knowledge from the educational intervention.~     They perform the positioning of the patient during the intraoperative fluoroscopy and record~     the image according to the teaching material. One postimplant image of each patient will be~     used for the evaluation.~      At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria~     (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the~     educational material.~   "
59915|NCT02272959|"~     First-line psychosocial treatments for anxiety disorders in children are largely~     exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting~     CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full~     course of treatment. What are the treatment options for these youth? Unfortunately, there is~     not a single empirical study in the youth anxiety treatment literature that has~     systematically examined treatment augmentation for youth who fail to respond to CBT.~     Empirical efforts to address this issue are important because youth who do not respond to~     CBT continue to suffer emotional distress and impairment associated with anxiety disorders.~     This study will address this gap via double-blind randomized controlled trial of Attention~     Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to~     standard CBT. Attention biases in threat processing have been assigned a prominent role in~     the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to~     implicitly modify biased attentional patterns in anxious patients. Here, participants will~     be CBT non-responders who will be assessed by using clinical interviews and parent- and~     self-rated questionnaires before and after eight sessions of ABMT or placebo control, and~     again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the~     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We~     also expect the findings to inform pathways to treatments for anxious children who do not~     respond to current standard first-line therapy, and to provide initial information on~     mechanisms of ABMT efficacy.~   "
59916|NCT02272946|"~     The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures~     of systemic and vascular inflammation and endothelial function (all indicators of~     cardiovascular risk) in treated and suppressed HIV infected individuals This study will~     assess the safety and effects of canakinumab on endothelial function (assessed by~     flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by~     FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk~     (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163),~     D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20~     individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.~   "
59917|NCT02272933|"~     In this observational study, a motion monitoring system including body-worn sensors,~     communication portals, data capture system, and algorithms will be tested with geriatric~     patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of~     a long-term effort to improve the quality of life and safety of geriatric patients by using~     autonomous systems that can alert care givers of mobility issues and falls.~   "
59941|NCT02272621|"~     This is a single-center, open-label, randomized controlled trial. Patients scheduled for~     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will~     be eligible. Twenty patients will be randomly assigned to either partial upper sternotomy~     (20 patients) or full sternotomy AVR (20 patients). Inclusion criteria is severe aortic~     stenosis referred for medically indicated isolated aortic valve replacement. Exclusion~     criteria are left ventricular ejection fraction less than 0.45, previous cardiac surgery, or~     urgent/emergent surgery.~      CE-marked and FDA-approved mechanical and bioprosthetic (stented or sutureless) aortic~     valves will be implanted. Cytokine release will be repeatedly assessed preoperatively and~     postoperatively (at 0, 6, 12, 18, 24 hours, and 3 days after surgery). Clinical~     characteristics will be registered. Clinical postoperative ouytcomes will be registered.~     Routine blood sampling will be performed pre- and postoperatively. All available data will~     be collected prospectively. Informed consent will be obtained from patients meeting the~     inclusion criteria before the initiation of any study-specific procedures.~   "
59918|NCT02272920|"~     Research hypothesis:~      Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it~     leads to improved cardiac function and attenuation of pathologic left ventricular~     remodelling? In a following study, the hypothesis will be tested in a larger ACS population~     with major adverse cardiovascular events (MACE) after ACS as the endpoint.~      Rationale for conducting this study:~      ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial~     infarction (non-STEMI) are the most important causes of morbidity and mortality in western~     societies. Hypertension is a major risk factor for development of ACS and heart failure but~     it also worsens the prognosis in patients after ACS. Our research highlights the combination~     therapy of PCI and RDN in an ACS patient population with simultaneous hypertension.~      Primary objective:~      The primary objective of this study is to establish safety and efficacy of combined~     treatment with PCI and renal denervation (RDN) in hypertensive patients with acute coronary~     syndromes (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary~     variable.~      Endpoints:~      The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by~     magnetic resonance imaging (MRI).~      Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes~     and ejection fraction.~   "
59919|NCT02272907|"~     The investigators hypothesize that staple line reinforcement will result in a higher leak~     pressure than a non-reinforced staple line closure in the resected gastric specimens from~     laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after~     various staple line treatments. The investigators will also analyze the most common site of~     specimen leak, association of stomach thickness to leak, association of stomach thickness to~     performance of the staple line techniques, and a cost analysis.~   "
59920|NCT02272894|"~     This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node~     dissection in 3-year survival rates of advanced gastric cancers.~   "
59921|NCT02272881|"~     The purpose of this study is to compare the number of and degree of pressure ulcers healed,~     as measured by intact skin at the original ulcer site at 6 months of follow-up in patients~     randomized to immediate operative closure versus those who are maintained in a wound care~     program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.~   "
59922|NCT02272868|"~     This is a double blind placebo control trial of fecal microbial transplantation for active~     Crohn's disease in patients 12 to 21 years of age.~   "
59923|NCT02272855|"~     The purpose of this study is to determine if HF10 in combination with ipilimumab is~     effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.~   "
59924|NCT02272842|"~     Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient~     deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is~     crucial for normal cell division and is necessary for brain growth as well as for the~     maintenance of its normal function. Deficiency is also associated with impaired growth. In a~     previous study, we demonstrated that vitamin B12 administration over a period of six months~     enhanced growth, and scores on a neuro-developmental test in young Indian children. However,~     the overall effect was small and, for the developmental scores significant only in those~     that were malnourished at the start of the study.~      Our findings need to be verified in trials targeting younger, malnourished children and with~     longer supplementation time.~      Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2~     recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted~     children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.~      Study design: Randomized placebo-controlled trial. Half of the children will receive a paste~     containing vitamin B12, the other half the same paste but without vitamin B12.~      Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In~     this population we have demonstrated that vitamin B12 deficiency and poor growth is common~     in early childhood.~      Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12~     months~      Data: The main outcomes of this study are scores on developmental assessments tools and~     growth measured every month for 12 months.~   "
59925|NCT02272829|"~     This project will develop a novel collaborative treatment, based on the primary care~     behavioral consultation model and behavior therapy techniques including motivational~     interviewing and functional assessment, in which a patient, a Behavioral Health Consultant~     (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed~     opioid analgesics in older HIV+ adults. The intervention will involve meetings between the~     BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid~     misuse will be the primary outcome variable. Quality of the patient-provider relationship,~     pain, problematic use of other substances, antiretroviral adherence, and psychosocial~     functioning will be secondary outcomes.~   "
59926|NCT02272816|"~     Metastatic seminoma is a relatively uncommon disease. The most widely used treatment for~     this disease is chemotherapy with the drugs, cisplatin and etoposide with or without the~     addition of bleomycin. This treatment combination has shown good survival rates however it~     is toxic usually requires an inpatient visit with administration over three days and can~     cause significant nausea, malaise, alopecia, risk of kidney damage, hypertension and high~     tone hearing loss.~      Previous studies have demonstrated that carboplatin is also effective in treating this~     disease type. Progression free survival is less than that seen with the combination~     chemotherapy yet overall survival is the same between the two treatments because of the~     effectiveness of second line salvage chemotherapy. Single agent carboplatin is a less toxic~     treatment and more convenient as it is given as a day case.~      A recent study run by the Orchid Clinical Trials Group looked at whether carboplatin (AUC10)~     is not only associated with fewer side effects, but more convenient to give as an outpatient~     treatment and that it is comparable in terms of cure rate. 20 patients were recruited to the~     trial and the results were encouraging with only one relapsed patient. This patient went on~     to be cured by conventional treatment. The positive outcome of the AUC10 trial has led to~     the design of this new multi centre study.~      This open labeled, multi centre trial will recruit up to 50 patients with good prognosis~     metastatic seminoma. All patients will receive three cycles of carboplatin AUC 10. Patients~     will be followed up for survival and closely monitored for side effects during treatment.~     Patients will have a PET-CT scan before they start treatment and after the completion of~     their first cycle. We hope that this scan will help us to identify which patients have~     responded metabolically and therefore not requiring an extra cycle of chemotherapy.~   "
59927|NCT02272803|"~     The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone +~     Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM)~     in Japan.~   "
59928|NCT02272790|"~     A Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial~     Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Patients will receive AZD1775 plus~     carboplatin or AZD1775 plus pegylated liposomal doxorubicin (PLD). The primary study~     objective is to evaluate the objective response rate (ORR).~   "
59929|NCT02272777|"~     The extension study follows the core study CAMN107ECN02, which is an open-label, two armed~     study. All patients enrolled in this extension study should be able to benefit from the~     treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension~     study patient will continue treatment of the drug (imatinib or nilotinib) which they are~     taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 will be retained. As long~     as we get EC approval and agreement from investigators, the selected sites for CAMN107ECN02~     will be applied in this extension study.~      Patients will be enrolled after eligibility evaluation. During the study, follow-up visits~     at a frequency of 6 months are required referring to the core study and recommendation in~     Chinese CML guideline. No data collection plan is included in this extension study except~     safety data. Investigator will be asked to report AE, SAE and pregnancy in order to ensure~     compliance with pharmacovigilance requirement. AE&SAE information will be recorded in CRF~     and included in clinical database. In addition, SAE and pregnancy will be reported to~     Novartis safety database.~      The extension study will start from first patient last dose date in CAMN107ECN02 and end at~     the time of nilotinib first line treatment commercially available in China.~   "
59930|NCT02272764|"~     This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.~   "
59931|NCT02272751|"~     This study will aim to compare the effects of an Exercise programme and a Relaxation~     Intervention in lymphoma patients in remission post-chemotherapy on quality of life,~     cardiovascular fitness, exercise tolerance, muscle strength, psychological status, social~     well-being and biological markers.~      Subjects will be recruited from a specialist lymphoma clinic in South West London and~     randomly allocated to an exercise or a relaxation home programme. The study aims to~     determine the more effective intervention of the two in relation to the outcome measures.~      The investigators anticipate that the interventions will result in less adverse events and~     improved quality of life and physical fitness, and subjects will require less medication,~     less counseling and cancer nurse specialist care, leading to leading to a reduction in~     hospital and surgery attendances.~   "
59932|NCT02272738|"~     The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine~     plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for~     unresectable locally advanced pancreatic adenocarcinoma.~   "
59933|NCT02272725|"~     The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory~     drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated~     hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over~     whether NSAID ingestion during endurance events contributes to acute kidney injury.~     Endurance events often ignite a perfect storm of physiologic insults- heat stress,~     dehydration, and myopathy- which can all negatively impact kidney function. There is a~     concern that NSAIDs may further potentiate these negative effects as well as contribute to~     EAH through its anti-diuretic affect. To date, no powered, prospective study has ever~     examined the effects of NSAIDs on either of these two biochemical outcomes~      Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are~     increasing in popularity, with a 10% increase in annual participants, and more than 69,000~     finishers worldwide in 2013. Considerable literature has documented alterations in serum~     biochemical profiles of these endurance athletes, with consistent evidence of elevated serum~     creatinine (Cr) levels in healthy race finishers as well as those seeking medical care.~     While acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury~     is common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage~     ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study~     showed that runners who ingested NSAIDs prior to marathons had greater post-race creatinine~     levels than matched controls as well as higher rates of hospitalization and acute renal~     failure. However, this contrasts with several other studies that showed a marked lack of~     difference in creatinine levels or development of acute kidney injury between NSAID users~     and non-users during ultramarathons. The only randomized trial to date on this subject found~     no difference in serum creatinine levels between the NSAID and placebo groups at~     ultramarathon race end, however conclusions were limited by a small unpowered sample size.~      Exercise associated hyponatremia (EAH), defined as a serum sodium concentration below~     135mEq/L, is recognized as a relatively common issue in endurance running events. The~     incidence of EAH varies depending upon the distance of the race, with reported values of~     3-28% for marathons, 23 - 38% for triathlons and 4-51% in single-stage ultramarathons. EAH~     is likely under-diagnosed as athletes are often asymptomatic. While EAH most often manifests~     as non-specific symptoms such as nausea, vomiting, dizziness, and fatigue, it can be a~     potentially fatal disease that can progress to encephalopathy, seizures, pulmonary edema,~     and death. There have been no large prospective studies examining the relationship between~     EAH and NSAID ingestion.~   "
59934|NCT02272712|"~     Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the~     general population. The Pan-Canadian sleep guideline for adults with cancer recommends~     Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems,~     however, are the lack of available CBT-I at cancer centers and the lack of information about~     possible side-effects of CBT-I. To address this issue, our study will evaluate the~     effectiveness and potential short-term side-effects of an online version of CBT-I. It is~     expected that when compared to cancer survivors who receive an online sleep education~     program, those who receive online CBT-I will experience improved sleep, mood, and quality of~     life, as well as reduced anxiety and fatigue.~   "
59935|NCT02272699|"~     Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell~     carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all~     cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial~     growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as~     first-line treatment in unresectable or metastatic ESCC. The results showed that the overall~     response rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median~     follow-up of 24 months, the median progression-free survival for patients with metastatic~     disease and local advanced disease were 8.2 months and more than 23 months respectively. The~     overall survival for patients with metastatic disease was 13.9 months. It implied that as~     first-line chemotherapy, an addition of nimotuzumab to chemotherapy was a more active~     treatment option compared to other regimens published in previous studies. Investigations by~     Liang, J. and Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or~     chemotherapy also showed anti-tumor activities and limited toxicities.~      Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant~     treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared~     with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal~     squamous cell carcinoma patients. We hope to explore if these neoadjuvant combination~     treatments could bring survival benefit for ESCC patients.~   "
59936|NCT02272686|"~     The goal of this clinical research study is to learn if ibrutinib can help to control~     lymphoma in patients who have had an autologous stem cell transplant (a transplant using~     your own stem cells). The safety of this drug will also be studied.~   "
59937|NCT02272673|"~     Febrile neutropenia (FN) is a common and serious side effect of chemotherapy. Current~     management of FN is expensive and may induce side effects. Honey is a natural substance~     produced by honeybees. It possesses antioxidant, antimicrobial and anticancer effects. In~     addition, honey is not expensive. The aim of this study was to evaluate the effects of~     12-week honey consumption on children with acute lymphoblastic leukemia (ALL) particularly~     with regards of FN episodes. This randomized crossover clinical trial included 40 patients~     of both sexes, aged 2.5 to 10 years. They were randomized into two equal groups~     [intervention to control (I/C) and control to intervention (C/I)]. The dietary intervention~     was 12-week honey consumption in a dose of 2.5g//kg body weight per dose twice weekly.~   "
59938|NCT02272660|"~     Evaluated the effect of perioperative parecoxib administration on postoperative pain,~     analgesic use, function recovery, inflammatory response and bleeding risk.~   "
59939|NCT02272647|"~     Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal~     women. Preliminary data are sought to estimate statistical power for more detailed studies~     of this hypothesis.~   "
59940|NCT02272634|"~     This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,~     3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice~     daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD) patients.~   "
59964|NCT02272322|"~     This observational study will evaluate treatment of symptomatic cystocele grade II-III with~     Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be~     collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of~     recurrence.~   "
59942|NCT02272608|"~     There is some evidence suggesting that OSA is associated with low level of systemic~     inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular~     damage has been implicated as the underlying mechanism responsible for comorbidities.~     Detection of altered inflammatory markers in OSAS patients may predict the degree of~     nocturnal sleep disturbance and associated systemic inflammation and presence of~     comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte~     ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge,~     NLR has not been studied in OSAS. We conducted the present study to evaluate the association~     between OSAS and inflammatory markers CRP, ESR and NLR.~   "
59943|NCT02272595|"~     The goal of this laboratory research study is to learn if using molecular information~     (matched therapy) or not using molecular information and having the study doctor choose the~     therapy based on your past experience are more effective ways to choose the best cancer~     treatment for you.~   "
59944|NCT02272582|"~     A prospective randomized, double-blinded, comparative within-person study to evaluate the~     use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.~   "
59945|NCT02272569|"~     Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and~     efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.~   "
59946|NCT02272556|"~     Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively~     measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours~     of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to~     assess cerebrospinal fluid levels of metabolites.~   "
59947|NCT02272543|"~     Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM:~     weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm)~     is a major cause of morbidity and mortality in under-5 children of developing/low-income~     countries. Approximately 14.6% of all under-5 mortality worldwide is attributed to MAM.~     Prevalence of MAM among under-5 children in Bangladesh is ~12% (~1.7 million). Providing a~     diet containing adequate nutrients is the mainstay of treatment of children with MAM.~     Dietary protein is mostly derived from vegetable sources for the middle and low income~     population among whom the prevalence of MAM and other forms of PEM is high. It is now~     possible to process fish into fish peptides with longer shelf-life without refrigerator,~     known as 'fish Surimi' and consumed by different categories of people who need more~     well-balanced protein; this could be an attractive alternative to supply fish protein in the~     diet of children in low-income countries like Bangladesh.~      Fish Surimi peptide is broken down from white fish meat using plant-derived enzyme and the~     ingredient is just fish meat consisted of 20 different kinds of amino acids including nine~     essential amino acids. In human studies it is found to help lowering blood lipids, glucose,~     IgE, hypertension, and increasing serum albumin and total protein, and bone density.~      The present study is designed to assess acceptability and efficacy of 'fish Surimi' in 2-5~     years old children suffering from MAM. A pilot study with two phases: to assess the i)~     acceptability with a small convenience sample (N=30) (phase 1); and ii) efficacy (rate of~     weight gain) of this fish peptide in a small convenience sample (N=70: 35 intervention 35~     control) (phase 2) is proposed.~      Acceptability trial (first phase): The investigators will conduct this study in the study~     ward of Dhaka Hospital of icddr,b. For each child the study will be for two days: i.e.~     direct observation of food intake of two lunches and two suppers. In a randomly manner and~     cross over design, an individual child will be offered 5g of fish Surimi during lunch and 5g~     during supper in one day or the same meal without any fish peptide on the other day in a~     blinded manner. The investigators will observe the completeness and eagerness of eating and~     any possible side effect (e.g. allergy, vomiting, diarrhea etc.) over these two days.~      Pilot efficacy trial (second phase): The investigators will conduct a pilot trial to assess~     the efficacy (mainly on child weight gain) of fish Surimi given at home with various~     foods/meals in 2-5 years old children with MAM will be conducted in Dhaka City of~     Bangladesh. Children will be enrolled from the Dhaka Hospital of icddr,b after improvement~     of any acute illness. The intervention group will receive (as take home supplementation)~     two-week's ration of fish Surimi (@10g/day in two doses i.e. 5g + 5g each in airtight~     packet), which will be served twice daily mixed with family diet. The control group will not~     be provided any supplements but the parents will be given dietary advice to provide~     nutritious food to the child in adequate amounts, and children of both groups will receive~     micronutrient sprinkle. The child's guardian will be supplied with fish Surimi during~     initial discharge from icddr,b hospital and requested to come for a fortnightly follow up at~     the nutrition follow-up unit (NFU) of icddr,b. During each follow-up visit the study~     research assistant/health worker will do the anthropometry, collect morbidity history since~     the last visit/follow up and dietary history will also be taken to find out how the child is~     doing along with the fish Surimi intake. Treatment of any illness will be provided as per~     standard method by on duty physician of the Dhaka Hospital of icddr,b. The ration for next~     two weeks will be provided and in such way each child will be followed for ~ 3 months over~     six NFU-follow-up visits. To reduce the possible drop-out the both-way transportation cost~     (~ 150 to 250 taka) during each follow-up visit will be reimbursed to the guardians. In the~     middle of the two scheduled follow-up days the research assistant will call the family by~     cell phone to monitor the child's feeding and morbidity status. Approximately 5ml blood will~     be collected from the ante-cubital vein of the children for biochemical test on enrolment~     and at the end of 3 months and will be analyzed for haemoglobin (Hb), c-reactive protein,~     zinc, ferritin, albumin, total protein, and IgE. During the blood drawing days each child~     will be given a toy (take home).~   "
59948|NCT02272530|"~     The aim of this study is to investigate wether change in endothelial nitric oxid synthase of~     blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on~     development and progression of cardiovascular diseases.~   "
59949|NCT02272517|"~     This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major~     depressive disorder (MDD) patients with inadequate response to current antidepressant~     treatment.~   "
59950|NCT02272504|"~     The objective of this study is to evaluate the clinical effectiveness of biomarkers,~     alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and~     des-gamma-carboxy prothrombin (DCP), for surveillance program patients whose hepatocellular~     carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects~     to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.~   "
59951|NCT02272491|"~     The aim of the present study is to test whether or not the use of translucent monolithic~     zirconia crowns bonded to a titanium base abutment perform similar to~     porcelain-fused-to-metal crowns on single implants in the posterior region.~   "
59952|NCT02272478|"~     AML 18 is the replacement trial for AML16 intensive. This 1600 patient trial is primarily~     designed for patients over the age of 60 who are considered fit enough for an intensive~     chemotherapy approach and will aim to test the effects of adding 1 of 2 new treatment agents~     to commonly used chemotherapy combinations in order to improve patient survival and~     treatment regimes.~      The AML18 Trial is available to any patient who has primary or secondary AML as defined by~     the WHO Classification (excluding Acute Promyelocytic Leukaemia), or high risk~     Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60.~      AML18 is a randomised controlled Phase III trial using a factorial design for maximum~     efficiency to evaluate two induction options followed by treatment with a small molecule~     post course 1 and dose intensification for suitable patients.~      There are four randomisation comparisons within the trial:~      The first randomisation will compare standard the chemotherapy schedule Daunorubicin/AraC~     (DA) combined with 1 or 2 doses of Mylotarg in course 1. Patients not suitable to receive~     Mylotarg may have DA alone. Following recovery from course 1 patients who fail to achieve CR~     or are MRD positive by centralised flow cytometry will be randomised to one of three~     options, either DA chemotherapy, DA chemotherapy plus Cladribine or Flag Ida for up to 2~     courses of therapy.~      Patients who achieve CR after course 1 will be randomised to 1 or 2 further courses of DA~     chemotherapy.~      At course 2 all patients will also enter a randomisation to receive AC220 versus no AC220~     with or without maintenance, or Ganetespib verses no Ganetespib for a maximum of 3 cycles.~     Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable~     HLA matched donor is available.~   "
59953|NCT02272465|"~     The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter,~     prospective observational study of air ambulance-based prehospital resuscitation regimens~     currently utilized at the participating sites. Patients will be enrolled at participating~     sites that currently have blood products available on air ambulances and other sites that do~     not. This study will not change the current prehospital standard of care for resuscitation.~     The primary outcome will be in-hospital mortality and the primary unit of analysis will be~     the patient. Other outcomes of interest will include time to hemostasis, hospital~     length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical~     procedures, complications (transfusion-related acute lung injury [TRALI], acute kidney~     injury [AKI], multiple organ failure [MOF], acute respiratory distress syndrome [ARDS],~     sepsis, intra-abdominal complications, thromboembolic complications, compartment syndromes),~     lifesaving interventions, the amount and type of blood products and concentrates transfused~     (including prehospital), wastage of prehospital blood products and concentrates, use of~     external and internal hemostatic devices, and functional status at discharge/discharge~     destination.~   "
59965|NCT02272309|"~     Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the~     lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from~     0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable~     SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in~     patients with LUT symptoms during low bladder volume and maximum cystometric capacity to~     assess reliability of measurements and influence of potential concomitant LUTS treatments.~   "
60014|NCT02271659|"~     The aim of the present phase III study is two-folded: 1) to show a superiority of external~     beam radiotherapy combined with a brachytherapy boost versus exclusive external beam~     radiotherapy and 2) to evaluate the economic impact of each treatment.~      The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is~     of 5 years.~   "
59954|NCT02272452|"~     The main ambition of this project is to develop, and provide the medical community, an~     innovative method to analyze extemporaneously, during a neurosurgery operation, excised~     tissues. This method is based on the analysis of the metabolic profile of excised tissues by~     the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance~     (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse~     (currently about 30 minutes but within our project a time lapse of 15 min or even less is~     ultimately intended), medical information that can complement those obtained by classic~     histological examination.~      Primary purpose:~      The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy~     in detecting residual tumor infiltration at the brain resection cavity. The investigators~     aim to determine the relevance of the metabolic analysis compared to histological analysis~     during a neurosurgery operation. This involves analyzing excised tissue samples, obtained~     from the operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center,~     with no return to neurosurgeon for surgery.~      Secondary purposes:~      The secondary objectives of the protocol are to investigate the metabolome of different~     types of brain tumors, in order to find prognostic and diagnostic markers. It consists in~     detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such~     as the IDH mutation.~   "
59955|NCT02272439|"~     The overall objective of this study is to determine whether serum BPA and/or phthalate~     concentrations differ in fertile versus infertile men and women in Saskatchewan. The~     investigators will test the following hypothesis:~        1. Serum BPA and/or phthalate concentrations will be greater in women with unexplained~          infertility or PCOS compared to a control group~        2. Serum BPA and/or phthalate concentrations will be greater in men with male factor~          infertility compared to a control group~   "
59956|NCT02272426|"~     It is estimated that 2 out of 3 patients with a stroke have some problems with their memory,~     difficulties performing certain tasks, making decisions and learning new things. In~     addition, many stroke patients do not get regular exercise and are often sedentary. Both~     physical and cognitive exercise have the potential to improve quality of life, cognition,~     and overall health, but the safety and tolerability of such interventions is not clear in~     stroke patients. The investigators will examine these outcomes by allocating stroke survivor~     participants to one of three groups: an exercise program, a combined exercise and cognitive~     training program and a sham control group.~   "
59957|NCT02272413|"~     The objective of this phase III trial is to establish statistical equivalence in terms of~     efficacy (best overall response rate [ORR], proportion of patients with complete response~     [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus~     chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with~     either BI 695502 or Avastin®.~   "
59958|NCT02272400|"~     Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1]~     No type I or II evidence is currently available to demonstrate equivalence to standard whole~     breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG~     (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast~     radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the~     results of this or similar trials are available, PBI remains a research domain, and it~     should be offered to patients only in the context of a clinical experimental protocol.~   "
59959|NCT02272387|"~     Our primary aim is to evaluate whether Vitamin D deficiency causes depressive symptoms in~     antepartum and postpartum depression and whether early correction of Vitamin D deficiency~     improves these symptoms.~      Our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum,~     and immediate postpartum complications. We are also evaluating the effectiveness of a common~     vitamin D treatment regimen used outside of pregnancy.~   "
59960|NCT02272374|"~     The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of~     different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous~     graft) in the elderly and very elderly with end-stage renal disease in China.~   "
59961|NCT02272361|"~     The primary objective of this study is to compare with PFDI-20 questionnaire the functional~     outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of~     symptomatic exteriorised cystocele up to 4 years after surgery.~      The secondary objectives of this study are the following:~        1. to compare the two techniques for anatomical results based on the clinical evaluation~          of patients with POP-Q.~        2. to overall quality of life assessment and expectations of patients.~        3. to compare the two techniques for the long-term safety. The evaluation will focus on~          the adverse effects of long-term sexual and genital symptoms, urinary and digestive~          functional symptoms, and chronic pelvic pain.~        4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire~          (matched-analysis before versus after).~   "
59962|NCT02272348|"~     Therapeutic education of patients is a mandatory component of intensive insulin therapy of~     type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim~     at facilitating patients' autonomy in their own management of diabetes. Therefore,~     self-management of patient with type 1 diabetes must be systematically assessed in order to~     evaluate the effectiveness of education programs .The main objective of this prospective~     controlled randomized monocentric study is to assess the impact of functional insulin~     therapy on the level of self-management of patients with type 1 diabetes via Confidence In~     Diabetes Self-care scale (CIDS) test.~   "
59963|NCT02272335|"~     The main goal of the proposed study is to test whether a successful stress management~     intervention can be effectively implemented in natural settings in the community and will be~     acceptable to a community dwelling, low income population of African American women with~     breast cancer.~      Hypothesis 1: There will be no differences between women randomized to either the Cognitive~     Behavioral Stress Management (CBSM) or the Cancer Wellness and Education condition (CW) on~     ratings of acceptability of the program.~      Hypothesis 2: Women randomized to the CBSM condition will show greater decreases over time~     in cancer-specific distress and greater increases over time in quality of life as compared~     to women in the CW condition over the course of the study from baseline to six month~     follow-up.~      Hypothesis 3: Women randomized to the CBSM condition will show greater improvement in pain~     levels, sleep disturbance and fatigue as compared to women in the CW condition over the~     course of the study from baseline to six month follow-up.~      Hypothesis 4: Women randomized to the CBSM condition will report fewer sick days, earlier~     return to work, fewer unanticipated health care visits, fewer visits to the Emergency~     Department and better follow-up with oncologists as compared to women in the CW condition~     over the course of the study from baseline to six month follow-up.~      Hypothesis 5: Women randomized to the CBSM condition will show more normalized patterns of~     diurnal cortisol (e.g., greater increase in negative AM-PM slope) as compared to women in~     the CW condition over the course of the study from baseline to six month follow-up.~      Hypothesis 6: Women randomized to the CBSM condition will show more less normalized patterns~     of heart rate variability (e.g., more variation) as compared to women in the CW condition~     over the course of the study from baseline to six month follow-up.~   "
82858|NCT01972841|"~     The purpose of this study is to examine how well two medicines (solifenacin succinate and~     mirabegron) combined work compared to each medicine alone in the treatment of bladder~     problems.~   "
59966|NCT02272296|"~     Using a specific jet injector for the administration of a rapid-acting insulin analogue has~     been shown to advance the absorption of insulin from the subcutaneous area into the~     bloodstream by 40-50%, when compared to conventional injection by insulin pens. The~     reproducibility of the jet stream method has not been previously determined in vivo. It is~     also unknown how the efficacy of injecting regular insulin by jet stream compares to that of~     rapid-acting analogues injected by conventional pen.~      Objectives: 1. To compare the pharmacologic reproducibility of the rapid-acting insulin~     analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected~     with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of regular~     insulin injected by jet injection to that of aspart insulin injected by conventional pen.~      Study design: Double-blind double-dummy randomized controlled parallel/cross-over~   "
59967|NCT02272283|"~     Coronary artery disease is one of the most prevalent diseases in the western countries.~      A waxy substance called plaque can build up inside the coronary arteries. Over time, plaque~     can harden or rupture, and cause narrowing (stenosis) of the arteries and reduce the flow of~     oxygen-rich blood to the heart.~      The standard treatment of symptomatic coronary stenosis is percutaneous coronary~     intervention (PCI) with balloon dilation followed by stent implantation.~      A stent is a small metallic grid that stabilizes the coronary vessel wall after the balloon~     dilation.~      Currently, drug-eluting stents (DES) are the most widely used stent types. DESs consist of a~     metallic backbone and an antiprolifetive drug-coating bound by a polymer (glue). These~     devices have reduced the incidence of excessive formation of new tissue (in-stent~     restenosis) dramatically in comparison with previously used bare-metal stents.~      However, there are safety concerns with DES, since later thrombotic events have been~     reported.~      On one hand excessive tissue formation inside the stent can cause in-stent restenosis, and~     on the other hand insufficient coverage of the stent can cause persistently exposed~     metalllic material that can induce platelet aggregation and thrombus-formation.~      The etiology to stent thrombosis is multifactorial. Possible predisposing factors are, among~     others: 1) hypersensitivity towards the polymer-coating, which may induce delayed healing~     inside and around the stent, and 2) insufficient contact between the stent and the~     underlying coronary vessel wall (incomplete stent apposition), which may cause~     flow-disturbance and delayed healing.~      Delayed healing causes persistently exposed metallic material that can induce platelet~     aggregation and thrombus-formation.~      The Nobori stent is a new-generation DES, coated with a thin layer of drug and a~     bioabsorbable polymer. The drug is localized on the outer side of the stent, and decreases~     the release of drug to the blood circulation. The bioabsorbable polymer is degraded after~     6-9 months after implantation, and decreases the risk of hypersensitivity-reactions in the~     vessel wall.~      The improved pharmacokinetic profile of the stent is thought to improve the healing pattern.~      At routine coronary angiography, a small plastic tube is inserted in the femoral artery~     under local anesthesia. Thin, flexible catheters are then advanced through the artery system~     (femoral artery and aorta) to the coronary arteries. Contrast is injected in to the blood~     stream by the catheters, and the arteries are depicted by a special X-ray technique during~     dye-release. By angiography, the outer sides of the coronary arteries are visualized, and~     balloon dilations and stent implantations are guided by this standard technique.~      Newer studies have documented that stent placement and expansion is superiorly visualized if~     supplementary intravascular imaging is performed during stent implantation.~      Small imaging catheters are wired through the vessel after stent implantation, and film the~     stent retrogradely through the vessel.~      Intravascular ultrasound (IVUS) visualizes the complete vessel wall by use of sound waves,~     and stent expansion is evaluated in detail.~      Optical coherence tomography (OCT) is a newer light-based, high-resolution technology. The~     technique can depict every thread (strut) from the stent, enabling visualization of both~     contact between struts and underlying vessel wall immediately after the procedure, and strut~     coverage at follow-up.~      The purpose of this study is to determine whether OCT-guided PCI can improve healing and~     coverage of the stent in comparison with routine angiographic guidance alone in patients~     indicating PCI due to myocardial infarction.~      If OCT-guidance improves coverage of the stent, this might lower the later thrombotic risk.~      Patients hospitalized due to myocardial infarction are randomized either to OCT-guided or~     angio-guided stent implantation in the present study. In both groups the Nobori stent is~     implanted according to standard techniques. In the angio-guided group, implantations are~     guided by angiography alone. OCT- and IVUS analysis are performed after an angiographic~     optimal result for documentary reasons. The operator is blinded towards the image findings,~     and analysis is performed offline later.~      In the OCT-guided group, both OCT and IVUS analysis is interpreted immediately after the~     acquisition. If stent apposition and/or expansion is deemed suboptimal, additional balloon~     dilation and/or stenting is performed. In case of OCT-driven stent optimization, a~     documentary OCT and IVUS is performed to document the final result.~      Patients are readmitted 6 months later for a control angiogram inclusive OCT to assess stent~     coverage.~      Furthermore, patients are readmitted 12 months after the index procedure for a control~     angiogram including OCT and IVUS to assess dynamic vessel wall responses.~   "
59968|NCT02272270|"~     This will be an open label, single arm study. Subjects with newly diagnosed high grade~     glioma will begin minocycline one week prior to beginning postoperative chemoradiation and~     continue it until progression, intolerance, or the end of adjuvant temozolomide, whichever~     comes first.~   "
59969|NCT02272257|"~     The purpose of this study is to determine whether seeing a physical therapist first compared~     with seeing a physician first is more clinically and cost effective in an occupational~     setting for acute musculoskeletal conditions.~   "
59970|NCT02272244|"~     This study is designed to test a standard mailed intervention (SI) versus a novel decision~     support and navigation intervention (DSNI). Working with patients and stakeholders, this~     randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age,~     patients in community based primary care practices, and are eligible for CRC screening. We~     will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI~     Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact~     on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC~     screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific~     CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and~     knowledge and perceptions.~   "
59971|NCT02272231|"~     The objectives of this study are to: (1) use cultivation-independent molecular methods to~     determine the sequence of microbiological events culminating in bacterial vaginosis (BV)~     among sexually active African American women who have sex with women (AAWSW) and (2)~     determine if specific Gardnerella vaginalis oligotypes are associated with the development~     of BV among sexually active AAWSW.~   "
59972|NCT02272218|"~     The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery~     as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory~     to medical treatment. The primary outcome will be the reduction in OA-related pain and~     disability after LAGB.~   "
59973|NCT02272205|"~     Infection is a serious complications after undergoing total hip replacement. It occurs in~     about 1% of cases. The optimal treatment of these infections is discussed. The team~     validated by international publications change strategy of the infected prosthesis at a~     time.~      Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination~     in orthopedic surgery rates. It must be conventionally administered before the surgical~     incision. In response to infection, it is typically recommended to start this antibiotic~     after the completion of the deep bacteriological samples, so as not to negate the risk of~     these samples by the prior administration of antibiotics. This attitude, however, is not~     formally validated by the scientific literature. In contrast, two recent publications~     challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even~     in septic interventions. Our multidisciplinary team opted for a few months for this new~     strategy. We wish to evaluate the influence of this new approach results in the treatment of~     infection in total hip or knee.~   "
59974|NCT02272192|"~     A multi-site randomized study of intensive treatment for toddlers with autism. This project~     proposes a three-site collaborative network plus a data coordinating center to evaluate the~     effects of intervention intensity and intervention style delivered for 12 months, on the~     developmental quotients (primary outcome) of very young children with ASD ages 12-30 months~     old and their families, and the effect of children's initial vocal skills, developmental~     rates and autism severity on their response to intervention. A second study will examine~     whether the effects of the Early Start Denver Model intervention are sustained over a three~     year period for 6-7 year old children who previously were enrolled in a two year study that~     compared ESDM treatment to usual community interventions.~   "
59975|NCT02272179|"~     Adolescent suicide is the 3rd leading cause of death in this age group. There are no~     validated treatments to decrease the risk of adolescent suicidal behavior, and there are~     especially no interventions to target the highest risk period for adolescent suicide and~     suicidal behavior, namely during the time of transition from inpatient to outpatient care.~     This project aims to develop a novel, brief intervention that can be delivered on an~     inpatient unit prior to the transition to outpatient care, will augment known factors to~     protect adolescents from suicidal behavior, and will extend the impact of treatment by~     liaison with the outpatient therapist and the development of a personalized safety plan~     phone application. This treatment, ASAP, focuses on augmenting Adherence to the components~     of ASAP and outpatient aftercare, development of a personalized Safety Plan, and Affect~     Protection, through helping the teen and family promote a positive mood, achieve healthy~     sleep habits, maintain sobriety, and access social support.~   "
59976|NCT02272166|"~     Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover,~     this aspect of post-operative period is often required for discharging patients from~     hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score~     (Chung score) whose validation evaluates patient's ability to return home.~      The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic~     effect of propofol compared to halogenated gases. These studies had neither the power nor~     the methodology to answer the question. The aim of our study is to evaluate the impact of~     propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.~   "
59977|NCT02272153|"~     The satiety effects of the combination of protein and fiber within egg and whole grain~     breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating~     than low protein, low fiber.~   "
59979|NCT02272127|"~     Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor~     (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine~     kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment~     with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is~     still under investigated. This study aims to observe and compare the efficacy and safety of~     intercalated combination of chemotherapy plus icotinib in patients undergoing resection of~     EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.~   "
59980|NCT02272101|"~     A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic~     rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms~     and rhinitis related quality of life.~   "
59981|NCT02272088|"~     The main purpose of this study is evaluate the effect of different intensities of exercise~     (moderate vs. intense) on the daily energy expenditure in overweight adolescents.~   "
59982|NCT02272075|"~     This trial will compare images obtained from a mobile colposcope with those obtained using a~     standard colposcope in women with abnormal pap smears. It is a non-inferiority trial.~     Blinded images will be evaluated be experts in colpsocopy and compared~   "
59983|NCT02272062|"~     Selection of a treatment strategy for patients with symptoms due to coronary artery disease~     requires consideration of patient preferences. In current clinical practice, patient~     preferences for treatment may not be known prior to diagnostic coronary angiography. The~     investigators will test an internet-based shared decision-making tool which will provide~     education and solicit preference information prior to angiography. The investigators seek to~     determine if this tool can accurately assess patient preferences, and if these preferences~     will lead to a change in clinical management.~   "
59984|NCT02272049|"~     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon)~     gas MRI for regional assessment of lung function in a normal population of children and~     adults and in adults and also in children with respiratory compromise due to a variety of~     diseases.~   "
59985|NCT02272036|"~     The purpose of this study is to analyze if integration of new media (SMS) could improve the~     quality of colonoscopy preparation.~   "
59986|NCT02272023|"~     A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of~     intensive motivational interviewing (IMI) to standard motivational interviewing techniques~     (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to~     IMI or a standard single session of motivational interviewing showed significantly better~     drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly,~     mean trajectories for women assigned to IMI showed continuing declines in drinking problems~     during and after treatment. Differences between study conditions grew larger between 4-month~     (p<.05) and 6-month (p<.01) follow-up and the effect size at 6 months was medium to large~     (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to~     respond to the PA's call for studies assessing mechanisms of change. Unlike many previous~     studies of SMI, we will employ limited exclusion criteria and will enroll participants who~     present with co-existing drug and psychiatric disorders.~      Procedures for the proposed study draw from our current successful RCT assessing IMI for~     methamphetamine (MA) dependence. Successful aspects of the current study include achievement~     of recruitment goals, strong adherence to the treatment and research protocols, and~     excellent rates for follow-up interviews (>90%). The proposed study will take place at the~     same outpatient treatment program as the current study, New Leaf Treatment Center in~     Lafayette, California.~      Participants will include 220 alcohol dependent women who will be randomly assigned to IMI~     or SMI. Those in SMI will also receive an attention component (nutrition education) to~     achieve time equivalence between the two study conditions. Participants in both groups will~     receive standard weekly group treatment offered at the program. In addition, referrals to~     Alcoholics Anonymous will be provided to all participants. The primary outcomes will be~     measures of drinking, heavy drinking (4+ drinks), and severity of alcohol problems assessed~     at baseline and 2, 6, and 12 months. Secondary outcomes will include Addiction Severity~     Index scales, psychiatric problems, and symptoms of trauma. The study will include standard~     quantitative testing of potential mediators, including, the therapeutic alliance,~     self-efficacy, motivation, satisfaction, and use of outside services. However, the~     application also proposes an innovative use of qualitative procedures to identify~     unrecognized factors influencing outcome.~   "
59987|NCT02272010|"~     Bipolar disorder (BD) is a chronic, often disabling illness, and many individuals remain~     symptomatic despite pharmacotherapy. Significant mood variability often persists throughout~     the lifespan and predicts relapse, leading to functional impairment. Metabolism of dietary~     essential polyunsaturated fatty acids has been shown to be upstream of the neuroinflammatory~     processes that may lead to neurotoxicity and chronicity of illness in BD. The investigators~     hypothesize that an intervention diet designed to alter intake of polyunsaturated fatty~     acids that augments mood stabilizing medications will reduce inflammation; and that the~     reduction of inflammation will reduce mood variability in bipolar disorder. After a two-the~     investigatorsek baseline-monitoring period, the investigators will randomize individuals~     with BD to an intervention or a control diet. Mood will be measured daily using a~     smartphone. Phase 2 will consist of 12 the investigatorseks of a less intense intervention.~     Follow-up will then be completed at 6, 9, and 12 months post-baseline to assess for~     recurrence of mood episodes. By maintaining a certain diet in addition to taking~     mood-stabilizing medication, researchers hope to see whether specific dietary plans have any~     bearing on mood variability.~   "
59988|NCT02271997|"~     Multicentre randomized controlled trial to evaluate the optimal treatment for patients who~     developed an iron deficiency after Roux-en-Y Gastric bypass.~   "
59989|NCT02271984|"~     This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The~     purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ~     [MSC2499550A]) oral dispersible tablet (ODT) formulation (150 mg) versus the current~     marketed praziquantel (PZQ) (cysticide® 500 mg) formulation in healthy male volunteers.~   "
59990|NCT02271971|"~     The purpose of this study is to determine whether supplementation with oral vitamin D~     (cholecalciferol) improves metabolic parameters in patients with moderate to severe~     psoriasis.~   "
59991|NCT02271958|"~     The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg~     doses of mifepristone against a placebo in women with laparoscopic diagnostic of~     endometriosis.~      The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and~     should be used in future studies on medical treatment of endometriosis.~   "
59992|NCT02271945|"~     This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680~     (AMP-514) in participants with relapsed or refractory aggressive B-cell lymphomas who have~     failed 1-2 prior lines of therapy.~      The primary objectives are to determine the maximum tolerated dose (MTD) or highest~     protocol-defined dose (HPDD); in the absence of exceeding the MTD of MEDI-551 in combination~     with MEDI0680 (AMP-514); and to evaluate the safety, tolerability, and clinical activity of~     MEDI-551 in combination with MEDI0680 (AMP-514).~   "
59993|NCT02271932|"~     A successful non-operative management strategy for early appendicitis will decrease the~     number of children requiring surgery and may improve the quality of care related to the~     treatment of appendicitis. To account for the child-family perspective and treatment~     preferences, the investigators will perform a study in which patients and their families~     choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at~     ten U.S. hospitals. This study will determine the effectiveness of non-operative management~     of early appendicitis with antibiotics alone in children and compare differences in~     morbidity, disability, quality of life, satisfaction, and cost between families choosing~     surgery or non-operative management.~   "
59994|NCT02271919|"~     Objectives:~      The goal of this clinical research study is to test two therapies that may help people quit~     smoking to determine if one is more effective than the other. The two therapies are Chantix~     (varenicline) and a combination of a nicotine patch and nicotine lozenge. For subjects who~     have not achieved smoking abstinence after 6 weeks, the objective is to determine if it is~     more effective to continue with the same therapy, change the therapy or augment the current~     therapy with an increased dose.~      Aim 1: To estimate the main effects of varenicline 2mg (VAR) and nicotine patch + lozenge~     (NPL) on smokers who remain on these medications throughout the trial.~      Aim 2: To estimate the probability that abstinence at twelve weeks as a function of~     treatment assignment at six weeks (augmentation) is moderated by initial treatment~     assignment (i.e. at baseline).~      Aim 3: To estimate the probability that abstinence at twelve weeks as a function of~     treatment assignment at six weeks (switching) is moderated by initial treatment assignment~     (i.e. at baseline).~      Aim 4: To estimate the probability that treatment continuation, switching, or augmentation~     confers benefit conditional upon failing to quit after the initial treatment with nicotine~     patch + lozenge (NPL) for six weeks.~      Aim 5: To estimate the probability that treatment continuation, switching, or augmentation~     confers benefit conditional upon failing to quit after initial treatment with VAR for six~     weeks.~   "
59995|NCT02271906|"~     The goal of this clinical research study is to learn if it is tolerable for patients with~     NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.~   "
59996|NCT02271893|"~     The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a~     decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced~     peripheral neuropathy compared to placebo group.~   "
59997|NCT02271880|"~     Investigates whether a family-based intervention for adolescents with Attention Deficit~     Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in~     adolescents with history of medication nonadherence.~   "
59998|NCT02271867|"~     Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks~     in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve~     block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic~     solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at~     investigating, in a quantitative way, the block characteristics of 3 different commonly used~     local anesthetics on peripheral nerves through the application of thermal QST by measuring~     changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be~     of value for measuring gradual changes in block characteristics on the adjacent nerves at~     distance of the injection site in an US-ISB.~   "
59999|NCT02271854|"~     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction~     of the pain associated with DOMS~   "
60000|NCT02271841|"~     This study evaluated the practice before and after the introduction of a particular model~     pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the~     patient.~   "
60001|NCT02271828|"~     STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the~     axilla, in order to positively influence the axillary morbidity rate and quality of life.~      PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not~     inferior to the current axillary staging regimen in clinically node negative breast cancer~     patients undergoing breast conserving therapy, in terms of regional recurrence rate.~      HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node~     negative breast cancer patients undergoing breast conserving therapy. This will lead to a~     decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease~     free- and overall survival rates.~   "
60002|NCT02271815|"~     There is a need for dentifrices that more effectively remove oral biofilm, and inhibit~     biofilm re-formation. This is particularly important is long-term orthodontic fixtures or~     prosthodontic appliances, and for debilitated, diabetic and immunocompromised condition.~   "
60003|NCT02271802|"~     In this placebo-controlled randomized parallel study the effects of a butyrate enema on~     plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera,~     liver and the splanchnic area are investigated~   "
60004|NCT02271789|"~     The purpose of this research study is to find a new way of using light to measure the blood~     flow within the tooth.~      The researcher develop dental Laser Speckle imaging system tool that can use for exam~     condition of the tooth. This device is reliable method to provide information to dentists~     and endodontists during oral examination.~   "
60005|NCT02271776|"~     Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern~     high in acetate and that this will lead to beneficial effects on human substrate and energy~     metabolism, we aim to address the following primary objective:~      To investigate the effects of a 12-week supplementation of GOS on peripheral insulin~     sensitivity and body weight control in obese adults with impaired glucose homeostasis.~   "
60006|NCT02271763|"~     The investigators will be comparing a traditional palpation (feeling) technique with an~     ultrasound technique for finding a specific part of the neck.~   "
60029|NCT02271464|"~     This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI~     regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus~     metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients.~      The main objective of this study is to preliminarily evaluate the potential effects of the~     combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to~     maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.~   "
60007|NCT02271750|"~     The global prevalence of dementia is close to 36 million (2010). Furthermore the number is~     predicted to double in the next 20 years, primarily due to the demographic ageing. A~     perspective that will challenge the current healthcare systems and national economies.~      Dementia is characterized by progressive deterioration in cognition, function and behavior~     that is sufficiently severe to compromise social and occupational functioning.~      The pathogenesis of dementia remains elusive. Thus, there is a need to increase our~     understanding of the mechanisms leading to the most common forms of dementia. A better~     understanding of the disease may enable an earlier diagnosis and importantly, a causal~     treatment of Alzheimer as opposed to the merely symptomatic options available to day.~      An experiment with rats and memory might already have taken the first step towards this. The~     experiment has demonstrated that administration of IGF-II to rats significantly enhances~     memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to~     an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of~     recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance~     memory retention and prevent forgetting.~      The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The~     immunological concentrations of IGF-I and -II are measured by validated in-house analyses.~     Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to~     measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of~     NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established~     techniques.~      The purpose of this study is therefore to define the concentration and biological activity~     of IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients~     with Alzheimer's compared with controls.~   "
60008|NCT02271737|"~     Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in~     maternal and under five year old mortality. Evidence exists that a large proportion of~     newborn mortality globally and in Cambodia is attributable to infections and sepsis. The~     study proposes a package intervention to address infection control in the perinatal period~     in facilities and to improve the timeliness of referral of newborns with suspected~     infections to appropriate health facilities for treatment through upgrading of hygiene~     practices in facilities and linking of community based volunteers with health facilities and~     families in the community setting.~      By delivering a coordinated intervention that combines improved education for health center~     midwives, village health care workers, and mothers of newborns, along with improved care~     coordination with increase in number of interactions (points of contact) between mothers and~     health care personnel, the investigators will see improved knowledge of newborn danger signs~     among mothers and health care workers, more rapid case detection of significant newborn~     illnesses, and more rapid and appropriate referral of ill newborns.~      The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are~     different from those reported in Western cultures, and that Staphylococcus aureus will be a~     common pathogen as described in neighboring Laos. The investigators will evaluate the causes~     of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.~   "
60009|NCT02271724|"~     Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy~     (MMN) are characterized by progressive deterioration in muscle strength, loss of~     sensibility, diminished or absent reflexes and impaired fine motor control. Often it is~     caused by demyelination which is suitable for treatment but damage to the axons may also~     occur especially in case of insufficient treatment.~      CIDP and MMN are immune mediated neuropathies in which first choice of treatment is~     intravenous immunoglobulin (IVIG), although the mechanisms underlying the effect of the IVIG~     is not yet clarified.~      The patients are diagnosed by electrophysiological examination and elevated level of protein~     in the cerebrospinal fluid. The diagnosis may be difficult to make due to great clinical~     variation and insensitive examinations methods including lack of biomarkers.~      The purpose of this study is to define if patients treated with SCIG and IVIG for CIDP and~     MMN have higher concentrations of sCD163 and CD19 in their cerebrospinal fluid and serum~     compared with symptomatic control subjects and is related to disease severity. Furthermore~     it is to define if patients newly diagnosed with CIDP or MMN have higher levels of sCD163~     and CD19, than patients treated regularly with SCIG and IVIG.~   "
60010|NCT02271711|"~     The goal of this clinical research study is to learn if infusions of a particular type of~     patients' own white blood cells called natural killer (NK) cells can reliably and safely be~     given to patients with brain tumors after the cells have been through a procedure to expand~     (increase) their numbers.~      Researchers also want to learn if NK cells infused through the ommaya reservoir can help to~     control the disease in patients with advanced brain tumors. The ommaya reservoir is a~     catheter system through which NK cells will be infused directly into areas of the brain~     called the fourth ventricle or the lateral.~      This is the first study of NK cells infused into the fourth ventricle of the brain in~     humans.~   "
60011|NCT02271698|"~     The purpose of the study is three fold. First to determine the ideal dose of dexamethasone~     intraoperatively that will reduce acute pain and opioid consumption. Second determine if~     dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty~     and finally determine if a pro-inflammatory environment makes patients susceptible to~     chronic pain after surgery and can dexamethasone alter this environment. Patients undergoing~     total knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg~     dexamethasone) and assessments will be made of acute and chronic pain and quality of life~     measures. Blood samples will be drawn to assess Interleukin levels and for Macrophage~     sorting. For the primary efficacy endpoint of reduction of opioid consumption over 24 hours~     after surgery the dexamethasone regimen group will be compared to standard of care group~     using t-test. For comparisons of the secondary efficacy endpoints, t-test, Chi-square test~     and Fisher's Exact test will be used. Risks of this study include the risks of venipuncture~     and intravenous dexamethasone administration.~   "
60012|NCT02271685|"~     Participants will be assigned to complete computerized estimation tasks for which there is a~     component of accuracy, such as estimating the duration of sounds. Participants will be told~     that the task is used as an early diagnostic tool to detect those at risk for a medical~     condition (e.g., Parkinson's disease, Alzheimer's disease). Instructions will be given to~     participants telling them that accuracy on the task is associated with the disease, whereas~     those who are not at risk of the disease tend to either overestimate or underestimate the~     duration of the sounds. The investigators examine whether such instructions about the~     purpose and diagnosticity of the tasks biases participants' responses to the tasks, leading~     them to purposefully be more inaccurate in their estimates.~   "
60013|NCT02271672|"~     This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive~     temporary reduction of waist circumference by disruption of adipocyte cells.~   "
61856|NCT02247570|"~     The specific aim of this proposed study is to compare the effectiveness of Vestibular~     Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain~     injuries in a randomized controlled trial in terms of PTSD symptom reduction.~   "
60015|NCT02271646|"~     Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital~     normally receive only intravenous sedative drugs which sometimes can not provide effective~     pain control.~      TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of~     using ultrasound guided which make it is more reliable and has less side effects especially~     the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use~     right TPVB at T5-6, T7-8, and T9-10.~      The aim of this study is to prove that TPVB can provide an effective pain control for~     patients undergo liver RFA both at rest and movement (cough). We are going to measure the~     pain score at recovery room and the effective pain control means patients has mild pain~     (pain score less </= 3 and do not ask for analgesic drugs).~   "
60016|NCT02271633|"~     The main aim of the current study will be to compare the effects of ingesting different~     nitrate-rich sources on plasma nitrite concentrations.~   "
60017|NCT02271620|"~     -  To determine prevalence of local allergic rhinitis (LAR)~        -  To evaluate clinical characteristic and severity of local allergic rhinitis~        -  To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus~          (Dp) after nasal allergen provocation test (NAPT)~   "
60018|NCT02271607|"~     This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of~     moxibustion therapy on overactive bladder (OAB) patients.~   "
60019|NCT02271594|"~     The investigators intend to assess the impact of optimized injection technique on the~     evolution of clinical parameters in insulin-treated patients with diabetes (DM) who have~     clinical lipohypertrophy (LH) in a controlled, prospective study with a follow-up of 6~     months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject~     into it will be randomized to either switch to normal tissue sites with intensive education~     as to why and how and use of a 4mm pen needle, or to continue with standard care. The~     endpoints measured will include the impact on glucose control parameters, consumption of~     insulin, hypoglycaemia rates, use of health services resources and health care costs~   "
60020|NCT02271581|"~     There is a growing body of evidence that implicates inflammation as a mechanism of disease~     progression and reduced survival in patients with advanced cancer. Elevated c-reactive~     protein levels have been shown to be associated with reduced performance status, specific~     cancer related symptoms and reduced overall survival. C-reactive protein levels are a~     surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer~     recurrence. VeriStrat® is a multivariate test which measures protein expression related to a~     host/tumor interaction mediated by inflammation. The investigators hope to examine the~     relationship between quality of life outcomes per FACT-L survey and correlate them with~     changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study~     is that the remarkable survival benefit in the Temel study is mediated by reduced~     inflammation with improvement of symptom control.~   "
60021|NCT02271568|"~     The purpose of this study is to determine the change in kidney function and blood pressure~     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly~     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24~     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical~     treatment.~   "
60022|NCT02271555|"~     The investigators will be evaluated the effects of a single loading dose of remifentanil~     (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile,~     seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with~     major depression~   "
60023|NCT02271542|"~     Identification of Polymorphisms Involved in the Metabolism of Propofol~   "
60024|NCT02271529|"~     The objective of this study is to evaluate the performance of the Zilver PTX stent~     thumbwheel delivery system.~   "
60025|NCT02271516|"~     This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of~     188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.~   "
60026|NCT02271503|"~     This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period,~     single-dose crossover study. Approximately 51 qualified immediate-release (IR)~     CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing~     sequences.~      Objectives:~        -  Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and~          levodopa) in subjects with advanced Parkinson's disease.~        -  Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.~   "
60027|NCT02271490|"~     Introduction To get through the egg vestment and fertilize the oocyte, the spermatozoon uses~     its acrosomal enzymes. When Intracytoplasmic sperm microinjection (ICSI) is performed, the~     acrosomal enzymes are introduced with the spermatozoa inside the ooplasme.~      The fate of these enzymes, that normally never enter the oocyte, is not known. But they~     impair the embryo development.~      Indeed, although the ICSI outcome is satisfactory in humans, a series of studies in many~     species (mouse, hamster, cattle, and horse) demonstrate the deleterious effects of the~     introduction of acrosomal material in the oocyte cytoplasm, on embryo and fetal development.~     These studies have also shown two things:~        -  The bigger the acrosome, the more deleterious are the effects of their introduction~          into the egg.~        -  And that the induction of the acrosome reaction (AR) prior to ICSI significantly~          improves embryonic development and the number of babies born after embryo transfer as~          it is the case in the mouse. The microinjection of acrosome reacted sperm increases~          from 40 to 70 % the percentage of pups born per embryo transferred.~      Hypothesis :~      It is possible to improve ICSI outcome, in terms of babies born in human, by induction of~     the AR prior to microinjection.~      After studying several techniques, we choose a physiologic technique for acrosome induction.~      The induction of acrosome reaction prior to ICSI should improve in utero fetal development~     and decrease the rate of miscarriage and pregnancy arrest.~   "
60028|NCT02271477|"~     Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic~     echocardiography is an effective method to guide titrated fluid repletion in non critical~     patients, in order both to decrease post procedural significant hypotension rate and to~     avoid unnecessary fluid overload in patients undergoing spinal anesthesia for elective~     surgical procedures~   "
61857|NCT02247557|"~     To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the~     treatment of IC/BPS~   "
60030|NCT02271451|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according~     to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs,~     LLC (Q30). Initial research suggests that the Device has the potential to reduce the~     likelihood of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith~     2012) has been approved for studies in humans and the results indicate safety for use during~     high demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board~     - Federalwide Assurance #00002988). Regarding safety, the externally worn collar is~     meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins~     that will provide similar pressure and volume increases not to surpass that of a yawn or the~     mere act of just lying down.~      This study will investigate the effectiveness of this device in high school athletes playing~     a collision or contact sport such as football, hockey, or lacrosse. The high risk sports~     which utilize helmets during competition will allow for measurements systems to be embedded~     in the headgear and will not affect play or fit of equipment. Athletes participating in this~     study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By~     the nature of the sports selected, it is likely this pilot study will primarily include~     males, however if any female meets inclusion criteria on the team selected they will be~     included in this pilot investigation. The helmets of all participants will be outfitted with~     an accelerometer which will measure the magnitude of every impact to the head sustained by~     the athlete. Effectiveness of the device will be determined by brain imaging during the~     pre-season, midseason, and end of season time points. A subset of athletes who report a~     diagnosed concussion will also receive additional brain imaging within the week following~     the diagnosed concussive event.~   "
60031|NCT02271438|"~     The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare~     the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and~     to assess the effects of a single dose of ibrutinib on QT/QTc intervals and~     electrocardiogram (ECG) in healthy adults.~   "
60032|NCT02271425|"~     Evacetrapib (study drug) is an investigational drug being developed with the aim to help~     people at high risk of heart problems in the future.~      In this study we will be comparing how much of the study drug gets into the blood stream~     when it is given as a single dose (in tablet form) compared to an intravenous injection~     (given directly into a vein via a small needle).~      The study is expected to last at least 15 days for each participant, not including~     screening. Screening will occur up to 28 days before the study drug is given.~   "
60033|NCT02271412|"~     Objectives~        -  To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in~          healthy subjects.~        -  To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.~   "
60034|NCT02271399|"~     The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin~     300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee~     arthroplasty.~   "
60035|NCT02271386|"~     Although numerous studies have demonstrated that a high percentage of primary care providers~     (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing~     ADHD, many fail to implement these guidelines correctly. The goal of this project is to~     increase the use of evidence-based practices (EBP) for assessing and treating children with~     ADHD between 5 and 12 years in the context of primary care practice. This randomized~     controlled trial will evaluate the whether a 3-part intervention (education about ADHD~     management and communication training, collaborative consultation, and performance feedback~     regarding use of EBPs) is effective in improving EBP use among primary care providers.~   "
60036|NCT02271373|"~     The purpose of this study is to develop a school-based intervention aimed at prevent the~     onset and development of myopia among school aged children by increasing time spent outdoors~     in northeast China.~   "
60037|NCT02271360|"~     The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral~     Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women~     underwent intracytoplasmic sperm injection (ICSI).~   "
60038|NCT02271347|"~     The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV)~     when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total~     of 5 doses.~   "
60039|NCT02271334|"~     The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of~     A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220~     mcg (T2), in healthy male and female adult volunteers.~   "
60040|NCT02271321|"~     The purpose of this study will be to examine the effects of white noise on agitation and~     saliva cortisol in elderly with dementia.~   "
60041|NCT02271308|"~     This study will examine the effects of low-resistance elastic band training on muscle~     strength, flexibility, quality of life and ease of care among the residents in nursing~     homes.~   "
60042|NCT02271295|"~     Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved~     in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in~     cirrhotic patients~   "
60043|NCT02271282|"~     Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to~     estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that~     estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and~     insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic~     syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in~     prostatic cancer~   "
60044|NCT02271269|"~     Glaucoma topical eye medications, when adhered to, are effective at controlling disease~     progression. Yet evidence shows that many glaucoma patients have incomplete adherence to~     medications, with disease progression resulting in significant costs to the patient and~     health system. Through the approach of value pricing, a link can be made between~     non-adherence and its resulting costs by granting subsidies to adherent patients for their~     medications and physician visits. This 6-month randomized controlled trial among 100~     glaucoma patients from the Singapore National Eye Centre aims to test the extent to which~     value pricing can improve medication adherence.~   "
60054|NCT02271139|"~     This is an open-label, multicenter, single-arm, expanded access study designed to provide~     alectinib to participants with ALK-rearranged NSCLC after disease progression on or~     intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive~     alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient~     or physician decision to discontinue treatment, death, alectinib becomes commercially~     available in the United States following approval of alectinib by the FDA, or the Sponsor~     decides to close the trial, whichever occurs first (approximately 15 months).~   "
60045|NCT02271256|"~     Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads~     to the three dimensional deformity of the spine. Spine curvature increases in youths as~     puberty progresses. Generally, only observation is suggested for adolescents with early~     scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the~     high corrective force which nearly constrains all movements. Flexible brace treatment is an~     alternative option; however, its efficacy is still controversial. Functional intimate~     apparel with a specialized design for teenagers with scoliosis is limited and most part of~     them can only provide some improvement for bad postures, such as hunchback. A scientific~     approach should be used to design and develop functional intimate apparel as a treatment~     option for adolescents with early scoliosis.~      This project aims to combine clinical experience with textiles and materials sciences to~     research and develop functional intimate apparel for adolescents with early scoliosis. As a~     result, this will reduce the future likelihood of brace wear or surgery.~      In this study, the eligible subjects will be given tailor-made functional intimate apparel~     to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18~     months wearing period. The effectiveness of the functional intimate apparel will be~     evaluated by pre- and post- treatment X-ray radiography.~   "
60046|NCT02271243|"~     Central line-associated bloodstream infections (CLABSIs) are the most common~     healthcare-associated infection in children and are associated with morbidity and mortality.~     This study will attempt to identify the source of bloodstream infections (BSIs) in children~     with CLABSI because we hypothesize that many of the BSIs that are currently classified as~     CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result~     of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will~     isolate bacteria from multiple body sites of children that have BSI in order to compare~     these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We~     will also evaluate biomarkers of MBI of the respiratory tract and GI tract.~   "
60047|NCT02271230|"~     This study will examine whether an intervention with vitamin D or fish oil supplements can~     reduce the risk of heart failure among adult men and women during a follow up period of up~     to five years (starting from the time of randomization into the parent VITAL trial). The~     investigators hypotheses are that both vitamin D and fish oil supplements will each reduce~     the risk of heart failure.~   "
60048|NCT02271217|"~     The objective of this study is to determine the effect of two dose strengths of~     dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable~     walking deficits in subjects with post-ischemic stroke.~   "
60049|NCT02271204|"~     This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent~     administration in patients with postmenopausal osteoporosis and the efficacy of IV~     Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral~     densitometry form baseline at year 1)~   "
60050|NCT02271191|"~     The aim of this study was to demonstrate the effect of nicardipine on renal function with~     creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium~     during deliberate hypotension for spine surgery.~   "
60051|NCT02271178|"~     Patients who survive an acute coronary syndrome are at high risk of recurrent events and~     death in the first months of evolution. Aspirin, angiotensin-converting enzyme,~     beta-blockers and statins decrease the risk of recurrent events and death, so are the~     recommended treatment for most patients who had a heart attack, and adherence to these~     recommendations is associated better clinical outcome. However, numerous studies show high~     dropout rate of medical treatment. The cause of nonadherence, common problem in chronic~     diseases, is multifactorial (economic, cultural, adverse effects), the complexity of the~     treatment being prescribed a relevant factor as a cause of non-compliance. The investigators~     goal is to assess whether the simplification of treatment for secondary prevention in a~     once-daily capsule containing four drugs increased adherence to it, compared to the standard~     treatment of each drug separately.~      The investigators design a controlled, randomized, open, parallel-group clinical study.~     Patients will be randomized to one of the following treatment regimens:~        -  Combined-Capsule: capsule containing an adjusted patient combination scheme for~          secondary prevention of once daily.~        -  Usual-treatment: each component of the dish separately as is the usual practice.~      The primary endpoint is the adherence of the treatment regimen to secondary prevention. For~     the study was considered adherent to a patient taking at least 80% of medication that~     belongs in the period.~   "
60052|NCT02271165|"~     The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin~     SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with~     Dermatomyositis. Hizentra provides effective protection against infection by maintaining a~     steady and normal level of immunoglobulin in the body) in patients with primary~     immunodeficiency. At present, patients with steroid resistant dermatomyositis can only be~     treated with IVIg (The healthy antibodies in IVIG can block the damaging antibodies that~     attack muscle and skin in dermatomyositis) treatment. An evaluation can then be made to see~     if SCIg is a suitable replacement and exerts immunomodulatory effect on complement~     antibodies.~   "
60053|NCT02271152|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence~     of 8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure~     and mortality. AF catheter ablation is an important treatment strategy for patients~     suffering from AF, but the success rate remains low after conventional pulmonary vein~     isolation (PVI). The mechanism perpetuating AF is poorly understood. Focal electrical~     sources and triggers (FAST) may sustain AF in some patients, which makes them a potential~     therapeutic target for ablation. However, finding FAST is very challenging due to complex~     nature of AF electrical signals. In this study, the investigators will attempt to localize~     focal electrical sources and triggers (FAST mapping) in patients undergoing AF ablation~     using custom software that evaluates periodicity and waveform morphology. Patients will be~     randomized to one of two AF ablation strategies, namely FAST mapping/ablation + PVI vs. PVI~     alone. The investigators will determine which strategy leads to better clinical outcome~     postablation.~   "
60079|NCT02270801|"~     This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at~     evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.~   "
83287|NCT01967225|"~     The aim of this study is to see the safety and efficacy of BAY1192631 when it is used for~     the treatment of skin and soft tissue infections (SSTI) or SSTI-related bacteremia.~   "
60055|NCT02271126|"~     The best anticoagulation strategy during Extracorporeal Membrane Oxygenation (ECMO) is~     unknown. Actual recommendations suggest to use unfractionated heparin infusion and monitor~     the effect with either activated Partial Thromboplastin Time (aPTT) or Activated Clotting~     Time (ACT). Since hemorrhage is still the major adverse effect of ECMO with impact on~     mortality and morbidity, the investigators raised a question whether an alternative~     monitoring technique namely Thromboelastography (TEG) could allow a more accurate management~     of anticoagulation in this setting. To test this hypothesis the investigators designed a~     pilot study to test safety and feasibility of an anticoagulation monitoring algorithm based~     on TEG versus aPTT.~   "
60056|NCT02271113|"~     In this study, the investigators will evaluate the safety, pharmacokinetics and effect on~     target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of~     GMI-1271, an E-selectin antagonist, in healthy volunteers.~   "
60057|NCT02271100|"~     This study is intended to determine whether ultrasound imaging can improve the ability to~     place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of~     ultrasound for the placement of epidural catheters the investigators hope to answer two~     questions:~      1. How does the traditional technique based on palpation compare to one using ultrasound to~     place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural~     placement?~   "
60058|NCT02271074|"~     The main objective of this study is to compare the effectiveness of combinations of three~     patient-oriented strategies, compared to the standard of care, to increase the proportion of~     patients who enter-into-care for HIV within 90 days of testing HIV positive.~   "
60059|NCT02271061|"~     The purpose of this study to investigate joint angle and joint moment in flexion-extension,~     adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic~     therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study~     requires ACL-injuries participants age range between 18 and 45 years old. The 3D motion~     analysis system (BTS, ITALY) and force plate (Kistler, USA) will be used for measure joint~     angle and joint moment during drop vertical jump movement.~   "
60060|NCT02271048|"~     Purpose~      - The investigators aim to evaluate the feasibility of remote interpretation for ultrasound~     images using a smartphone based realtime image transmission system.~      Methods~      A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and~     remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound~     images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis~     will be consecutively selected. The 12 raters review these original images using an LCD~     monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound~     machine via remote image transmission system (CubeView, Alpinion medical system, Seoul,~     Korea), evaluating left ventricular systolic function (for echocardiography) by measuring~     the ejection fraction and grading the probability of presence of acute appendicitis on each~     examination by a five Likert scale.~      The sensitivity and specificity between two devices will be compared and the diagnostic~     performance between two devices will be also compared. The image quality between two devices~     will be measured using the double stimulation impairment scale (DSIS)~   "
60061|NCT02271035|"~     Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at~     1% of newborns, and 30-45% of the children who present with urinary tract infection (1).~      Optional treatments of children with VUR include conservative therapy with or without~     prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.~      In an endoscopic technique, the injecting needle is inserted through the working channel of~     the cystoscope. The procedure is relatively short and is performed as out-patient surgery.~      In 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has~     become the treatment of choice in VUR grades 2-4.~      In 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT~     involves the use of a pressurized stream of fluid directed into the ureter to aid~     visualization, and injection into the submucosa within the ureteric tunnel to improve~     coaptation of the ureter (3).~      One of the disadvantages attributed to Deflux is the loss of 20% of the injected material~     over time (a result of absorption of the hyaluronic acid), which may explain the lower~     success rate of the endoscopic treatment of VUR compared with open surgery.~      In 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was~     introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by~     preventing volume loss. Preliminary results of a three year follow-up using Vantris have~     shown high a level of reflux resolution(4).~      The aim of the current study is to compare the rate of resolution of the VUR using Deflux~     versus Vantris in bilateral VUR~   "
60062|NCT02271022|"~     The primary objective of the UPSTREAM Registry is to address the data gap regarding the~     course of NSTEMI (Non-ST-Elevation Myocardial Infarction)between ED (Emergency Department)~     arrival and diagnostic angiography in detail, by characterizing and following the ED and~     peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED~     treatment patterns and success of both ischemic and bleeding risk stratification prior to~     definition of the coronary anatomy, data generated via the UPSTREAM registry will allow~     plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet~     therapy in the management of NSTEMI. This registry further seeks to demonstrate that~     contemporary use of upstream ticagrelor is associated with an economically-sound utilization~     of hospital resources, and smooth transition of care into the outpatient, secondary~     prevention setting for the first 30 days after hospitalization. Finally, it will allow~     characterization of patient selection factors and processes for ticagrelor vs alternative~     OAP agents, carrying out that descriptive comparison through discharge. Patients transferred~     in to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent~     administration and diagnostic catheterization begin with ED care at the first hospital.~   "
60063|NCT02271009|"~     The purpose of this study is to find the optimal dose of AllerT that should be used to treat~     moderate to severe allergies due to birch tree pollen.~      There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at~     different doses and 1 treatment group will receive placebo.~      This study will also assess the effectiveness and safety of AllerT compared to placebo in~     relieving allergy symptoms.~   "
61966|NCT02246140|"~     There is an association between intracranial arterial stenosis and ischemic stroke in young~     adults. The aim of this study is to evaluate the prevalence of intracranial arterial~     stenosis in asymptomatic regular resin of cannabis users in comparison with control~     subjects.~   "
60064|NCT02270996|"~     Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis~     patients do not require antibiotics after appendectomy. Although guidelines and~     recommendations exist to decrease post-operative antibiotic mis-use after appendectomy,~     surgeons continue to prescribe unwarranted antibiotics.~      The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric~     Surgery will decrease the use of un-warranted antibiotics.~   "
60065|NCT02270983|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment~     for chronic non-cancer pain that has been present for a minimum of 3 months.~      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.~     Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or~     placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel~     movement frequency, as well as other bowel symptoms of OIC.~   "
60066|NCT02270970|"~     This will be an open label, non-randomized trial of belimumab in at least 20 subjects to~     test the feasibility of belimumab as a single agent and to capitalize on simplified~     background treatment regimens to determine immunologic differences between patients who do~     versus do not meet clinical response criteria.~   "
60067|NCT02270957|"~     This is a randomized, double blind, placebo controlled trial of abatacept for the treatment~     of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3~     tender and 3 swollen joints and </= 20 mg prednisone have other background immune~     suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg~     depomedrol (in two or more injections) between the screening visit and the visit 2 months~     after dosing begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous~     doses. After 3 months of treatment patients who are not responding may elect to receive open~     label abatacept with or without additional standard of care therapies. Such patients are~     considered non responders. The primary endpoint is the British Isles Lupus Assessment Group~     Index (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically~     significant improvement in arthritis and other active features of lupus~   "
60068|NCT02270944|"~     The purpose of the present study is to assess and compare in healthy non-pregnant women 18~     to 40 years of age the safety and immunogenicity of a liquid formulation of Group B~     Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to~     administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered~     in non-pregnant and pregnant women in the clinical development program to date.~   "
60069|NCT02270931|"~     The purpose of this study is to obtain sufficient specimens and correlating clinical data~     from a well-controlled prospective clinical trial collecting longitudinal specimens from~     subjects diagnosed with any stage of breast cancer.~   "
60070|NCT02270918|"~     Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug~     Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with~     non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA~     approved drug derived from blood that is used as an antidote to treat people with bleeding~     associated with taking the well-known anticoagulant warfarin. This is a Phase I,~     placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility~     apixaban anticoagulation with Kcentra.~   "
60071|NCT02270905|"~     The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial~     replacement of the native medial or lateral meniscus with the investigational product.~   "
60072|NCT02270892|"~     Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera®~     treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following~     the last treatment. Study images will be obtained pre-treatment, immediately post-treatment,~     and at each follow-up visit.~   "
60073|NCT02270879|"~     Prediction errors for the first (PE1) and second eyes (PE2) were obtained in the~     intra-ocular lens power calculation for 4 formulae (HofferQ, SRK II, SRK/T and Holladay 1).~     The optimal correction factor for each formula was determined as the one resulting in the~     lowest mean absolute error. A similar analysis was performed in the negative and positive~     PE1 subgroups.~   "
60074|NCT02270866|"~     This is a pilot study with a single active treatment arm. The study is designed to assess~     the efficacy of a portable, non-invasive neuromodulation system for the treatment of~     post-stroke aphasia. Both language and movement assessments will be made.~   "
60075|NCT02270853|"~     In this study it will be analyzed how often the sleep apnea syndrome can be observed in~     patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.~   "
60076|NCT02270840|"~     Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes~     in patient in left ventricular dysfunction and intermittent or permanent apical/septal right~     ventricular pacing (Budapest CRT upgrade study)~   "
60077|NCT02270827|"~     This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients~     continue to experience symptoms and up to 5% of these have difficult-to-control asthma~     despite continually improving treatments. Severe asthmatics experience~     clinically-significant worse health-related quality of life than those than those with less~     severe asthma. Poorer health-related quality of life can be as a consequence of frequent,~     severe symptoms, which prevent the patient from continuing a normal, active lifestyle. The~     Royal Brompton Hospital uses the treatment regimen of intravenous (IV) Aminophylline and IV~     Hydrocortisone which appears to improve symptoms and reduce exacerbations. At present there~     is anecdotal evidence to support these assumptions. The objective of this study is to~     determine whether there is any objective evidence of improvement, in particular looking at~     lung function, symptoms and cardiovascular function.~   "
60078|NCT02270814|"~     The purpose of this research study is to look at the effect of a treatment regimen called~     CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called~     cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of~     cisplatin if participants have previously had problems receiving cisplatin). The use of~     nab-paclitaxel in this combination is different from routine care, in which a drug called~     5FU is often given instead, but the investigators group has conducted previous research~     where the investigators incorporated nab-paclitaxel into routine treatment with cisplatin,~     5FU, and cetuximab. The investigators are looking at the incidence of side effects with the~     CACTUX regimen as well as response of the disease and health status.~   "
60080|NCT02270788|"~     PRIMARY OBJECTIVE:~      This is a pilot study to characterize the toxicity profile, to determine the maximum~     tolerated dose of the combination of crenolanib and sorafenib, and to determine the~     feasibility of administering these drugs in patients with relapsed or refractory hematologic~     malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic~     syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with~     FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.~      The study will include two phases:~        -  The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and~          determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of~          crenolanib when given in combination with sorafenib.~        -  The dose-expansion cohort will further assess the safety and explore the efficacy of~          this combination.~   "
60081|NCT02270775|"~     The study will include a translation of the Central Sensisization Inventory into French and~     a cultural validation of the French version of the questionnaire (Reliability,~     discrimination and comparison with other questionnaires).~   "
60082|NCT02270762|"~     In the critically patient bed rest and inmovilization are some of the responsable of the~     development of respiratory complications. Early physical exercise is a tool to prevent~     respiratory complications as lost of respiratory muscle strength, decrease in functional~     residual capacity and hypoxemia improving oxygenation. In some cases critically ill~     conditions implies use of pharmacological sedation. That condition limit the active physical~     exercise. However, some technicals aids as Tilt table allows execution of passive early~     movilization.~      The aim of this study is to assess the effect of early passive verticalization assisted by~     tilt table on alveolar recruitment and pulmonary ventilation in intensive care unit (ICU)~     patients, evaluated with electrical impedance tomography (EIT) ICU patients included at day~     of evaluation will be evaluated consecutively with EIT in three stages; 1) in the supine~     position (at 30° of inclination), 2) verticalized in tilt table (at 60º of inclination) 3)~     in the supine position (at 30° of inclination)~   "
60083|NCT02270749|"~     The purpose of this study is to evaluate the most effective treatment for patients who~     underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.~   "
60084|NCT02270736|"~     The objective of this study is to investigate the efficacy and safety of NT 201 compared~     with placebo for the treatment of chronic troublesome sialorrhea associated with~     neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual~     disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17~     years.~   "
60085|NCT02270723|"~     In a randomized clinical trial, the purpose is to investigate if perioperative coagulation~     and hemorrhage is influenced by colloid or crystalloid.~   "
60086|NCT02270710|"~     It is well known that the deregulation of immune responses plays a major role in many~     autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this~     protocol is to determine whether the expression and/or function of specific molecules are~     deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6,~     SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to~     sex hormones, the investigators hypothesize that the deregulation in the expression and~     function of these molecules will result in abnormalities in the functioning of the immune~     cells, which is a key factor in autoimmunity.~      Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected~     and compared in order to determine if specific immune cells (IL-17 and IL-21) are~     deregulated in patients with SLE and if this deregulation affects their functioning.~     Specifically, immune cells will be isolated from the blood and then subject to scientific~     testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis) to see~     if the expression and function of these cells is related to the mechanism behind SLE. This~     will be a case control study, where cases of SLE will be compared to controls of healthy~     volunteers to assess risk factors. As these healthy volunteers are providing samples solely~     for research purposes, there is no standard of care for these volunteers, with the exception~     of a positive HIV result during screening. The Department of Genetic Medicine will enroll~     healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic~     Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts. Laboratory testing~     on all blood samples will be done at the Hospital for Special Surgery.~   "
60087|NCT02270697|"~     The nail specimens from patients with suspect onychomycosis were analyzed. Samples were~     collected as part of standard patient care from the Department of Dermatology, National~     Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan.~     Comparing the array results with the regular methods by sensitivity, specificity, NPV and~     PPV.~   "
60088|NCT02270684|"~     The purpose of this study is to compare the short-term changes in gait parameters and~     functional outcomes after total knee arthroplasty between those who use the StepRite device~     and those who follow a standard therapy program without the device.~   "
60089|NCT02270671|"~     Attention bias modification training (ABMT) is a computer-based attention training programme~     designed to modify the way a person's attention is directed to mild threats in the~     environment. What a person focuses their attention on plays an important role in how safe or~     unsafe they feel in certain situations. Much research has shown that people with high levels~     of anxiety tend to focus their attention on negative information in their surroundings. The~     purpose of ABMT is to set in place attention patterns that do not lead to excessive anxiety.~     The present study will test whether this treatment is effective in reducing social anxiety~     in 15-18 year olds in school settings.~      The study design consists of two phases. During Phase 1 participants will complete a~     screening questionnaire in relation to their wellbeing and emotions. This questionnaire will~     include a measure of the affective, cognitive, and behavioural components of social anxiety~     in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a~     standardised measure of social anxiety in Phase 1 of the study), participants may then be~     invited to take part in a 4-week computer-based attention training programme. The purpose of~     this phase is to see if ABMT will help young people feel less worried or nervous in social~     situations by teaching them to focus on their environment differently.~      Previous research containing attention training tasks similar to this training programme~     suggests that attention training can reduce symptoms of social anxiety in adolescents.~     Individuals who are invited to take part in the training session will be randomly assigned~     to either the intervention or placebo (inactive) group. Both groups will be asked to~     complete a 4-week programme involving one computer training session per week (each session~     takes approximately 15-20 minutes).~      Questionnaires will also be given to participants to complete before and after the~     intervention, along with a 12-week follow up assessment. These will include questionnaires~     to measure social anxiety, depressive symptoms, and fears in relation to negative~     evaluation. Each questionnaire will take approximately 40 minutes to complete. Participants~     will not know whether they have received the intervention or placebo training until after~     the intervention.~   "
60090|NCT02270658|"~     MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with~     uncontrolled hypertension and at least one antihypertensive medication. Those patients with~     significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.~   "
60091|NCT02270645|"~     Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish~     to or cannot tolerate other treatment modalities such as topical chemotherapeutics or~     surgery.~      In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm~     Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm~     in size. This is an unblinded study in which patients will be randomized to either a~     treatment arm or a control arm. Patients in the treatment arm will receive three treatments~     with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit~     the clinic with the same schedule as the treatment group for monitoring of the lesion. All~     patients will return one month after last treatment session or clinical visit, for~     evaluation of clinical and histological clearance.~   "
60092|NCT02270632|"~     A multicenter, randomized, parallel assignment, double blind, placebo-controlled,~     safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients~     with active rheumatoid arthritis receiving MTX.~   "
60093|NCT02270619|"~     Late-life depression is a major public health burden due to its high prevalence and~     associated morbidity, suicide risk, functional decline, and mortality. Unfortunately,~     current antidepressant therapies have limited effectiveness; hence, biologically plausible~     models for new treatments are being pursued. Systemic inflammation is hypothesized to play~     an important role on the onset and perpetuation of depression, especially in older women.~     Aging processes involve a heightened inflammatory state, and both inflammatory disorders and~     depression are more prevalent in women than men. However, increased systemic inflammation~     does not necessarily lead to depression in all women. Even when robust systemic inflammation~     is experimentally induced (e.g. endotoxin administration), largely variable increases in~     depressive symptoms are found. Defining the factors that account for this variability may~     identify individuals at risk of developing depression when exposed to heightened~     inflammatory states such as aging, obesity, and chronic disease, and informs future~     translational studies of depression prevention. In particular, the role of sleep disturbance~     in explaining this variability requires further attention because it is an independent risk~     factor for depression and heightens systemic inflammation by increasing the production of~     proinflammatory cytokines. The investigators have also discovered that women, but not men,~     who report sleep disturbance including short sleep duration experience significantly more~     depressive symptoms in response to an inflammatory challenge than women without sleep~     disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for~     inflammation-induced depressive symptoms in women. However, to date, no experimental~     approach has been used to evaluate the role of sleep loss on inflammation-induced depressive~     symptoms. This proposal aims to examine this hypothesis by partial sleep deprivation (PSD)~     followed by endotoxin challenge in older women. It also aims to explore genomic and socio-~     emotional mechanisms underlying the association between sleep loss and depressive symptoms.~     In a randomized controlled factorial design, 80 healthy female volunteers aged 60 to 69 will~     be randomly assigned to one of 4 arms: 1) uninterrupted sleep followed by placebo; 2)~     uninterrupted sleep followed by endotoxin; 3) PSD followed by placebo; or 4) PSD followed by~     endotoxin. Subjects will be administered placebo or endotoxin in the morning after PSD or~     uninterrupted sleep. Depressive symptoms will be repeatedly assessed over 6 hours after~     placebo or endotoxin administration.~   "
60094|NCT02270606|"~     This phase I trial studies the side effects and best dose of fluorouracil when given~     together with radiation therapy followed by combination chemotherapy before and after~     surgery in treating patients with rectal cancer that has spread from where it started to~     nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells~     and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving more than~     one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving additional combination chemotherapy~     after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil~     followed by combination chemotherapy before and after surgery may be a better treatment for~     rectal cancer.~   "
60095|NCT02270593|"~     Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the~     oxidant / antioxidant enzyme levels.~   "
60096|NCT02270580|"~     A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in~     which (condition 1) we will evaluate the efficacy of a culturally tailored PN program~     (PN+) on improving quality of life (QoL), screening practices and treatment follow-up~     compliance among breast HL survivors. In usual PN, participants will receive information~     brochures on breast cancer survivorship and have a minimum of 1 contact with the patient~     navigator.~   "
60097|NCT02270567|"~     Neuroendocrine tumors are derived from the neuroendocrine system of the~     gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include~     surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy.~     Survival is linked to early and accurate diagnoses or to the effective detection of disease~     recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood~     tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the~     effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET~     registry aims at collecting data and blood samples from patients presenting with a NET in~     the USA. Data will be entered prospectively and anonymized after informed consent. All~     physicians who treat neuroendocrine tumor patients are invited to participate to the~     registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy~     for biomarkers in the different types and grades of tumors, treatment modalities and patient~     outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of~     the role of biomarkers in tumor management.~   "
60098|NCT02270554|"~     The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple~     Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal~     pancreatectomy by a prospective, multi-center trial.~   "
60099|NCT02270541|"~     Interventional prospective randomized open blinded end-point (PROBE) single-center clinical~     trial on the evaluation of the efficacy, safety, feasibility, reliability, and~     cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.~   "
60100|NCT02270528|"~     This study will examine the acute effects of high intensity interval ergometry on peripheral~     concentrations of lactate and hydrogen ions, as well as cognitive function. Approximately 60~     healthy, college-aged males will participate in the Wisconsin Card Sorting Task (WCST), a~     measure of executive function, two times over a span of two weeks. Prior to the WCST,~     participants will complete either a warm-up, a warm-up and high intensity interval exercise,~     or a stationary period. Changes in lactate, pH, and WCST score will be evaluated between and~     within groups in relation to the presence of the high intensity exercise stimulus.~   "
60112|NCT02270372|"~     This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with~     varlilumab. Two different doses of varlilumab will be studied in combination with the single~     agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10~     may also be studied at the recommendation of the safety monitoring committee (SMC).~   "
60101|NCT02270515|"~     This study will implement and evaluate a patient-centered medical home for kidney disease~     (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an~     initial baseline period under the usual care model and then the usual dialysis care team~     will be expanded to include a pharmacist, health promoter, nurse coordinator and a primary~     care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after~     the PCMH-KD intervention commences.~   "
60102|NCT02270502|"~     The primary aim of the study is to evaluate consequences of frailty in critically ill~     patients. We hypothesize that a higher frailty index (based on published questionnaires)~     predicts a longer surgical intensive care unit and hospital length of stay, less~     ventilator-free days and a higher likelihood of an adverse discharge disposition.~      Our secondary aim is to identify muscle-size derived variables that can be used to predict~     frailty. We hypothesize that a low skeletal muscle mass measured by ultrasound can be used~     to quantify frailty, and to also predict the outcome of SICU patients, expressed as longer~     stay in the surgical intensive care unit and longer stay in the hospital, less~     ventilator-free days and a higher likelihood of an adverse discharge disposition.~      Our third aim is to examine potential triggers of muscle wasting in critically ill patients.~     Muscle wasting will be assessed by repetitive ultrasound measurements of muscle mass. We~     hypothesize that a significant decrease in skeletal muscle mass predicts longer stay at the~     surgical intensive care unit and longer hospital length of stay, less ventilator-free days~     and adverse discharge disposition.~   "
60103|NCT02270489|"~     This is a randomized controlled parallel Group phase I study to investigate the safety and~     immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE®~     PD03A, given to patients with early Multiple System Atrophy (MSA).~      In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment~     arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A~     (with adjuvant) and 6 patients in the control group who will receive the reference substance~     (Placebo). Over a study duration of 52 weeks, the study participants will receive 4~     injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks~     after the first injection. Male and female patients aged 30 to 75 years can participate in~     the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.~      AFF009 is part of the project SYMPATH funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).~   "
60104|NCT02270476|"~     The purpose of this study is to further characterize early CF lung disease in newborns,~     infants and toddlers with cystic fibrosis (CF).~   "
60105|NCT02270463|"~     This is a non-randomized open label multi-center study. Patients who are in their first~     complete remission (CR) following induction therapy will be treated with SL-401, which will~     be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6~     or more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be~     treated with SL-401 at 3 dose levels. During Stage 2, approximately 24-29 patients with~     minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated~     dose or maximum tested dose in which multiple dose-limiting toxicities are not observed~     (identified in Stage 1).~   "
60106|NCT02270450|"~     This partially randomized clinical trial studies surgery or non-surgical management in~     treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a~     common problem for advanced cancer patients and can negatively affect quality of life. It is~     not yet known whether surgery or non-surgical management is the best treatment option for~     bowel obstruction and can lead to better quality of life.~   "
60107|NCT02270437|"~     We investigated the safety and efficacy of the bilateral periarticular cocktail injection at~     a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.~   "
60108|NCT02270424|"~     The aim of this study is to compare the effectiveness of two treatments for severe / very~     severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments~     and conventional medicine, which have been evaluated and have certain effect.~   "
60109|NCT02270411|"~     The objective of this non-therapeutic experiment is to develop a method to isolate~     inflammatory cells from skin biopsies as well as a method to evaluate the expression of~     genes in those cells that are involved in inflammation. It could eventually be used to~     better understand the following conditions: atopic dermatitis, acne rosacea and acne~     vulgaris. It can also be used to better understand how various medications work in patients~     with atopic dermatitis, acne rosacea and acne vulgaris.~      Up to 15 healthy volunteers, 15 subjects with atopic dermatitis, 15 subjects with acne~     rosacea and up to 15 subjects with acne vulgaris will be selected. For healthy volunteers~     and subjects with atopic dermatitis, a maximum of four (4) skin biopsies (2-4 mm) per~     subject will be taken.~      For subjects with acne rosacea and acne vulgaris, a maximum of two (2) skin biopsies (3 mm)~     per subject will be collected. Biopsies will be performed on either the trunk or the limbs,~     excluding the hands and the feet. The biopsies will be used to develop a method to isolate~     inflammatory cells from the skin. Various protocols will be tested to find the best method.~     No medication will be given to you for this experiment.~   "
60110|NCT02270398|"~     Background Functional community ambulation not only requires a critical level of postural~     control and walking skills, but also the ability to engage in cognitive tasks while walking~     (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There~     is evidence showed that dual-task balance and gait performance is significantly impaired~     after stroke. Increasing evidence also suggests that dual-task balance and gait performance~     is useful for predicting falls among individuals with stroke. Considering the high clinical~     relevance of dual-task balance and gait performance, it is essential that stroke~     rehabilitation adequately addresses dual-task deficits. Developing specific dual-task~     balance and gait training to enhance dual-task performance is thus necessary to promote~     community ambulation and reintegration.~      Study Aim The aim of this Introduction Many individuals after stroke continue to cope with~     residual physical impairments after discharge from hospital. One of the major problems~     encountered by people after stroke is community reintegration. Functional community~     ambulation not only requires a critical level of postural control and walking skills, but~     also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and~     adapt to the constantly-changing environmental contexts. There has been an increasing~     awareness of the importance of dual-task gait performance in community-dwelling individuals~     with stroke in the past few years.~      There is evidence showed that dual-task balance and gait performance is significantly~     impaired after stroke. Increasing evidence also suggests that dual-task balance and gait~     performance is useful for predicting falls among individuals with stroke. Considering the~     high clinical relevance of dual-task balance and gait performance, it is essential that~     stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task~     balance and gait training to enhance dual-task performance is thus necessary to promote~     community ambulation and reintegration.~      Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this~     study is to examine the efficacy of a dual-task exercise program on cognitive-motor~     interference in balance and walking tasks, balance self-efficacy, participation in everyday~     activities, community reintegration and incidence of falls among individuals with chronic~     stroke.~   "
60111|NCT02270385|"~     This study is aim to evaluate the effectiveness of a PU prevention programme for for-profit~     private NHs.~   "
60113|NCT02270359|"~     The purpose of this study is to determine the prevalence of plaque disruption and to assess~     the composition of disrupted plaques in patients with myocardial infarction (MI) and~     non-obstructive coronary artery disease (CAD) using optical coherence tomography (OCT).~     Additionally, cardiac magnetic resonance imaging (CMR) will be used to detect myocardial~     abnormalities, which will be correlated to OCT findings to gain insight into the mechanisms~     of MI in patients with non-obstructive coronary artery disease (i.e. open arteries).~   "
60114|NCT02270346|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects~     in many body tissues, organs and systems such as immune, cardiovascular, pulmonary,~     gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and~     skin.Available limited numbers of studies showed that inspiratory muscle weakness in~     allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies~     demonstrated beneficial effects of inspiratory muscle training on several outcomes in~     different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart~     failure, no published paper reported the effects of IMT in allo-HSC recipients.~   "
60115|NCT02270333|"~     Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea~     and quality of life in patients with sarcoidosis. However, no study investigated the effects~     of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with~     sarcoidosis were investigated.~   "
60116|NCT02270320|"~     Background: Promotion of cognitive functions of middle aged and older adults and prevention~     of dementia are important issues in the aging society. In recent years, studies have shown~     that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and~     older adults, but not studies have investigated the neural mechanisms. Therefore, the~     purposes of this research project are: (1) to investigate the effects of TCC exercise~     intervention on improving cognitive functions and motor functions in healthy middle-aged and~     older adults; (2) to investigate the effects of TCC intervention on improving the integrity~     of frontostriatal fiber tracts, and areas and intensity of brain activation while performing~     a switching task in healthy middle-aged and older adults.~      Methods: This project used the assessor-blind and randomized control clinical trial design.~     A total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to~     two groups: experimental and control groups. Experimental group will receive a 60-minute~     exercise program, three times per week for 12 weeks. Control group will receive a telephone~     consultation once every two weeks for 12 weeks. All participants will receive clinical~     neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor~     function tests, diffusion spectrum MR imaging, and functional MRI experiments before~     intervention, and at the end of intervention to realize the changes of cognitive function,~     motor function, integrity of neural tracts, and intensity and regions of functional~     activation while doing switching task of executive function in order to understand the~     cognitive effects and the neural mechanisms of TCC.~   "
60117|NCT02270307|"~     Evaluating the effectiveness of the new protocol which replace the standard~     immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.~   "
60118|NCT02270294|"~     The investigators hypothesize that Acute Thai traditional massage will yield beneficial~     effects on cerebrovascular reactivity in ischemic stroke patients.~   "
60119|NCT02270281|"~     Although EGDT goals appeared to have been achieved, severe derangements of organ perfusion~     were detected by SDF technique.An abnormal microvascular flow index was present in 17% of~     patients in ICU . Microcirculatory alterations are stronger predictors of outcome than~     global hemodynamic variables.Improvement of microcirculatory dysfunction is a big challenge~     to clinician. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation~     of adult critically ill patients which exhibits sedative and analgesic effects. Recent~     studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in~     septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced~     by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with~     severe sepsis. The investigators will conduct a clinical trial to investigate the effect of~     dexmedetomidine on microcirculatory dysfunction in early septic shock patients with relative~     stable hemodynamics.~      thirty patients with septic shock will be enrolled . After sufficient fluid resuscitation~     and hemodynamic stabilization for 24 hours, these patients who required sedation will~     receive continuous infusion of two dose of dexmedetomidine (infusion rate 0.3 and 0.6~     mcg/kg/h) for 1 hours as needed. The sublingual microcirculation and serum level of~     catecholamine will be examined at preset time points. The vital signs, hemodynamic~     parameters will be recorded and analyzed.~   "
60120|NCT02270268|"~     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary~     fiber, on clinical symptoms, gut microbiota and the immune status in patients with~     diarrhea-predominant irritable bowel syndrome~   "
60121|NCT02270255|"~     Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However~     the procedure is often very painful and, in many centres, patients are admitted overnight~     with PCA pumps for pain control and discharged the next day with heavy pain medications. The~     goal of this study is to evaluate the effectiveness of a superior hypogastric nerve block in~     controlling the pain post-UFE.~   "
60122|NCT02270242|"~     The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and~     aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and~     forming a blood clot that could block blood flow to the heart. This study will look to~     determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus~     aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events~     among high-risk patients who have had a percutaneous intervention with at least one~     drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or~     anatomic criteria.~      Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting~     randomization eligibility criteria at 3 months post enrollment will be randomized to either~     ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up~     clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.~   "
60138|NCT02270034|"~     This multicenter, open-label, phase Ib trial aims to assess the safety and activity and~     safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients~     with newly diagnosed glioblastoma.~   "
60123|NCT02270229|"~     The purpose of this study is to develop recommendations to assist in improving the current~     peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will~     consist of a needs assessment, a review of aggregate quantitative patient data from hospital~     records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers,~     laboratory technicians, patients and primary caregivers. The final report will be used to~     obtain funding for the implementation of the recommendations.~   "
60124|NCT02270216|"~     Aim to study the exercise responses to both static and dynamic exercise in elderly people~     with and without essential isolated systolic hypertension, seeking to identify potentially~     dangerously high responses~   "
60125|NCT02270203|"~     The purpose of this study is to evaluate the long term safety and effectiveness of SI joint~     fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or~     sacroiliac joint disruptions (SD).~      Study Design: This study is extended follow-up from two ongoing multicenter prospective US~     clinical trials. All participants have already undergone the surgical procedure of interest~     (SI joint fusion with iFuse Implant System). The two ongoing trials are:~        -  SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of~          patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent~          iFuse placement, and~        -  INSITE(Investigation of Sacroiliac Fusion Treatment):~      a randomized clinical trial of the same patient population who underwent either non-surgical~     treatment or iFuse placement~   "
60126|NCT02270190|"~     The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can~     improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those~     who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior~     Resection Syndrome.~      The secondary research questions are to see if other pelvic floor symptoms and quality of~     life improves for this patient group and if levels of anxiety and depression improve for~     these patients.~   "
60127|NCT02270177|"~     Headache is a frequent cause of visits to the GPs office, and the investigators have~     previously shown that this group accounts for about 20 % of patients referred to a general~     neurologic outpatient clinic.~      To our knowledge, no previous study has investigated whether headache consultation through~     telemedicine provides equal health care outcomes compared to regular visit to the~     neurologist. If that's the case, a modern interactive health care system may give simpler~     and cheaper services for patients, saving travelling costs and community expenses. It may~     possibly also lead to reduced waiting lists, earlier diagnosis and treatment.~      This is an open-labeled randomized non-inferiority trial of headache patients referred to a~     neurologic clinic in North-Norway. The aim of this study is to determine whether video~     consultations are non-inferior to regular consultations in diagnosing and treating primary~     headaches. The null hypothesis is that there is no difference in patient satisfaction~     between the two groups. The outcome is assessed 3 and 12 months after the neurologic~     consultation.~      Participants will be allocated to either a telemedicine consultation or a regular~     consultation at the neurologic outpatient clinic in the University Hospital of North-Norway,~     Tromsø. Both groups will undergo a structured and detailed interview to clarify the~     diagnosis and establish appropriate treatment. To ensure the best possible representation in~     the population, our goal is to include at least 70% of all the referred patients that meet~     the criteria for participation. The randomizations are made through a centralized 8-16 phone~     line to the research-department in Tromsø, at the University Hospital of North-Norway.~      Both primary and secondary endpoints will be assessed in questionnaires sent three and 12~     months after the consultation. In addition, the quality of the physicians` referrals and~     calculations of cost savings by using telemedicine will be evaluated.~      The patients' informed consent will always be obtained before data collection. Patients are~     able to withdraw from the study at any time. Withdrawal will not affect the treatment or~     follow up. Local research ethics committee (REC) has approved the study.~   "
60128|NCT02270164|"~     Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some~     clinical trial data suggesting benefit in the treatment of cholesterol disorders in several~     countries, but this effect has not been studied in a U.S. population. The investigators will~     give ALE or a placebo to overweight men and women with low good cholesterol to see if ALE~     increases their good cholesterol. The investigators will also make sure that ALE is safe.~   "
60129|NCT02270151|"~     Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can~     be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of~     strokes related to undetected AF increases with ageing. If AF is timely diagnosed and~     treated accordingly with anticoagulants, disabling strokes can be prevented. In order to~     help physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a~     CE certified device that is safe, user friendly and easy to use. This device is capable of~     detecting or excluding AF within one minute by providing a registration of lead I of the~     ECG.~      The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients~     aged 65 years and over who visit the general practice. In total the investigators will~     include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and~     21 to the control arm. All persons aged 65 years and over who visit the general practice in~     the MyDiagnostick arm will be asked to hold the device every time they visit the surgery~     during one year.~      The number of newly detected cases of AF with the diagnostic screening strategy with~     MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the~     number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared~     between both arms. Finally, the investigators will assess the number of major adverse~     cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and~     all-cause mortality between the arms. End points will be assessed blinded to allocation.~      The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial~     fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.~   "
60139|NCT02270021|"~     The goal of this study is to prevent over screening and over treatment of young women for~     cervical precancers, which can result in psychological distress and has been associated with~     future risk of premature deliveries. Current national guidelines recommend that routine~     screening be performed at less-frequent intervals and that excisional cervical therapies are~     discouraged in young women. The objectives of this study are to examine physician- and~     patient-based interventions designed to decrease over screening and over treatment by~     increasing adherence to US guidelines for women under 30 years.~   "
60222|NCT02268942|"~     This is a prospective, multi-center,single arm study that will evaluate the thoracotomy~     implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD®~     System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory~     Support (INTERMACS®) protocol and database.~      All participating centers will be current INTERMACS® sites in good standing and will follow~     the INTERMACS® protocol and procedures.~   "
65568|NCT02199106|"~     Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to~     modulate auditory cortex activity and plasticity contributing to the perception and distress~     of chronic tinnitus.~   "
60130|NCT02270138|"~     The aims of the study: Main objective of the current study is to decrease sedentary behavior~     and increase physical activity among mothers and their offspring by using music-to-movement~     video program. Primary outcomes of the study are objectively assessed sedentary behavior and~     physical activity time measured both in minutes and as a proportion of measurement time.~     Secondary outcomes of the study are quantity and quality of self-reported screen time among~     mothers and children and motivational quality of music and music-to-movement video.~     Additional secondary outcomes are mother's weight, workability, mental health and mood.~     Specific aim is to study effectiveness of intervention with accelerometer use only or with a~     combination of accelerometer plus music-to-movement video program for mother-child pairs.~      Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video~     program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle,~     counselling and exercise in maternity care (NELLI) -project from 14 municipalities of~     Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs.~     accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement~     of sedentariness and physical activity is based on accelerometer. Information on current~     health behavior will be based on intervention questionnaires. In the analysis physical~     activity, sedentary time and body weight of the intervention and control group will be~     compared. Effects of mother's musical (and PA) background and other mediating factors will~     be analyzed separately in subgroup analyses.~   "
60131|NCT02270125|"~     The aim of this prospective study is to evaluate presence and quantity of nano-sized~     particles and interindividual differences in their distribution and elemental composition in~     human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic~     rhinosinusitis and to compare the obtained results with control specimen obtained from~     stillborn children.~   "
60132|NCT02270112|"~     Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is~     present.~      The investigators hypothesize that the activation of the atrial myocardium resulting in the~     p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for~     AF.~   "
60133|NCT02270099|"~     This clinical performance study is being conducted to evaluate the performance of the Aptima~     Herpes Simplex Viruses 1 & 2 assay for detection of herpes simplex virus (HSV) type 1~     (HSV-1) and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV~     lesions in the male anogenital region, the female anogenital region, the oral cavity and~     other mucomembranous or mucocutaneous areas of the face (oral/facial), and the skin.~     Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima~     swab collection kits will be evaluated.~   "
60134|NCT02270086|"~     The investigators have recently developed an innovative optical molecular imaging platform~     (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a~     hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact~     means of obtaining instantaneous image-based measurements of diagnostically-relevant~     biological and molecular information of a wound and surrounding skin tissues for the first~     time and could have significant impact on improving conventional wound care, management, and~     guidance of intervention. In preliminary preclinical testing, the investigators have~     discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the~     connective tissue matrix emit a characteristic green fluorescent signal, while most~     pathogenic bacterial species emit a unique red fluorescence signal due to the production of~     endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast~     agents are needed during imaging, making this approach particularly appealing as a~     diagnostic imaging method for clinical use.~      In the context of this study, PRODIGI is used to assess wound complications in patients~     diagnosed with soft tissue sarcoma and treated with pre-operative radiotherapy. Both pre-~     and postoperative external beam radiotherapy combined with limb salvage surgery have~     similarly high rates of local control in the management of extremity soft tissue sarcoma.~     The main acute side effect associated with preoperative radiotherapy is wound healing~     complications. Wound care overall is a major clinical challenge and presents an enormous~     burden to health care worldwide. The objective of this clinical study is to determine if~     PRODIGI coupled with an optical tracking platform has clinical utility in identifying,~     quantitatively measuring and longitudinally tracking bacterial imbalance on the patient's~     intact skin surface at the location of the surgical resection site for adult patients with~     lower limb soft tissue sarcoma treated with preoperative intensity-modulated radiation~     therapy and limb salvage surgery and, further, to investigate whether this bacterial~     imbalance is related to radiotherapy dose and wound complications.~   "
60135|NCT02270073|"~     Background: Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500~     years old and can be defined as a specific form of attention that is non-judgemental,~     purposeful, and focused on the present moment. It has been well established in cognitive~     behavior therapy in the last decades, while it has been investigated in manualized group~     settings. Consequently, the demand to investigate mindfulness under effectiveness conditions~     in trainee therapists has been highlighted.~      Methods/Design: To fill in this research gap, the investigators designed the PrOMET-Study.~     In this study, the investigators will analyze the effects of brief, audio-tape presented,~     in-session mindfulness interventions conducted by both trainee therapists and their patients~     at the beginning of individual therapy sessions in a randomized, controlled longitudinal~     design under effectiveness conditions in a total of 30 trainee therapists and 150 patients~     in a large outpatient training center. The investigators hypothesize the mindfulness~     intervention will have positive effects on therapeutic processes and outcome in contrast to~     a progressive muscle relaxation and a treatment as usual group. The investigators will~     conduct multilevel modeling to address the nested data structure.~      Discussion: The study results could provide important practical implications, as they could~     inform ideas on how to improve clinical training of psychotherapists that could be~     implemented very, as there is no need for complex infrastructures or additional time~     concerning these brief, in-session mindfulness interventions that are directly implemented~     in treatment sessions.~   "
60136|NCT02270060|"~     The purpose of this research study is to:~        1. Investigate the effects of a single 20-minute music therapy intervention with a music~          therapist on the pain intensity, pain relief, and mood of adult patients with sickle~          cell disease as compared to:~             1. Adult patients with SCD who listen to their preferred music for 20 minutes without~               the presence of a music therapist (music listening group)~             2. Adult patients with SCD who receive standard care alone (control group)~        2. Determine the feasibility (delivery, acceptability, and usefulness) of the music~          therapy intervention for pain management~   "
60137|NCT02270047|"~     A 4 week double blinded parallel design with an intervention condition and a control~     condition will be employed. After having completed screening procedure and a baseline test~     day, participants will be randomized to either intervention or control condition. In the~     following 4 weeks, the participants will have to consume the distributed food product daily~     before completing another test day.~   "
60248|NCT02268604|"~     Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL~   "
60140|NCT02270008|"~     Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy.~     It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor~     hygiene and increased risk for genitourinary tract infection. These women suffer from a~     combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy~     progresses. Though anal incontinence may subside in the postpartum period, a subset of women~     will have continued anal incontinence or recurrence of anal incontinence with subsequent~     pregnancies or as they age. As of December 2012, only one study has explored the effects of~     pelvic floor muscle training (PFMT) on reducing the development of this condition in the~     pregnant population. However, that study took place in Scandinavia with little demographic~     correlation to a US population and lacked postpartum followup. Although their results showed~     little effect of PFMT on anal incontinence, they recommended further research to be~     performed prior to making definitive conclusions.~      Multiple studies have explored the effects of PFMT on urinary incontinence, and the general~     consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as~     an initial test to explore whether such a positive relationship holds for anal incontinence~     throughout pregnancy and postpartum period for a diverse population. The format will be a~     prospective feasibility trial comprised of a one-time intensive in-person pelvic floor~     muscle training course at the first prenatal visit with at home instructions for continued~     exercise. This group will be compared to a control group which receives a hand-out regarding~     PFMT but no personalized instruction. The progress of the participants and their symptoms of~     incontinence will be monitored during pregnancy and at the postpartum visit using~     standardized validated pelvic floor questionnaires, based on previously designed surveys. A~     sample size of 100 parous women ages 20-35 year old will be randomized to an intervention~     and control or standard therapy group. The investigators' hypothesis is that the~     intervention group will show a 50% risk reduction, similar to the urinary incontinence~     studies. The results of this study will then allow us to design a broader intervention study~     for which to study the effects of PFMT and anal incontinence during pregnancy and the~     postpartum period.~   "
60141|NCT02269995|"~     This surveillance's objectives are:~        1. Unknown adverse reactions~        2. Incidences of adverse drug reaction~        3. Factors considered to have effect to safety and effectiveness~   "
60142|NCT02269982|"~     This study will develop a first-in-man CTC-based molecular taxonomy of CRPC in the context~     of novel AR-directed therapies, categorize different patterns of resistance in this disease~     setting, and describe their evolution over time and treatment.~   "
60143|NCT02269969|"~     Effective antimicrobial use in the burn population is important since this population is at~     an increased risk for infections during their stay in hospital as a result of their burn~     injury. Tobramycin is an antibiotic that has activity against common burn wound associated~     pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due~     to the increased incidence of bacterial resistance to currently utilized antibiotics. Once~     daily dosing of tobramycin has been safely and effectively used in the majority of infected~     patients for many years with the proposed benefits of optimized antibacterial activity and~     reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen~     has yet to be validated in the burn population. The purpose of this study is to validate the~     plausibility of once daily tobramycin dosing in the burn population with intent to determine~     a safe, effective, and efficient dosing regimen for this population.~   "
60144|NCT02269956|"~     The purpose of this study is to combine current evidence-based guidelines with adaptive~     leadership (AL) training to assist nursing staff to navigate the delicate balance of~     necessary technical and adaptive work to improve problematic dementia-related mealtime~     symptoms.~   "
60145|NCT02269943|"~     The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously~     treated subjects with locally advanced or metastatic nasopharyngeal carcinoma having failed~     one to two previous regimens, including platinum-based chemotherapy. Approximately 51-55~     subjects will be enrolled according to a Simon two-stage design; if the predefined activity~     is met (>4 responses [complete response; partial response {CR/PR}] out of the first 17~     evaluable subjects based on independent radiological assessment), then the study will~     continue to enroll an additional 34 subjects. If < or = 4 responses out of 17 are observed,~     then the study enrollment will be stopped.~   "
60146|NCT02269930|"~     The primary outcome of the study is to evaluate the cumulative area under the concentration~     time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose~     (AUC0-336h), for serum concentrations of BIIB017 and Rebif.~      The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of~     BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2~     weeks in healthy volunteers.~   "
60147|NCT02269917|"~     The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a~     once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/~     emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing~     the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir~     disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type~     1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter~     [copies/mL]) HIV-1 infected participants.~   "
60148|NCT02269904|"~     SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during~     operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA.~     The study is a post-marketing study. The subjects will be divided into two groups (Group A~     and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan~     during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will~     receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The~     subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two~     groups.~   "
60149|NCT02269891|"~     The purpose of this study is to assess the effectiveness of an herbal combination product~     called Nu Femme, on menopausal symptoms in peri-menopausal women.~   "
60150|NCT02269878|"~     To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas~     gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural~     mesothelioma (MPM)~   "
60151|NCT02269865|"~     Study to focus on the defining and managing the neuropsychological abnormalities of myotonic~     dystrophy and to find out if the neuropsychological abnormalities have any correlation with~     changes seen on Magnetic Resonance Imaging.~   "
60152|NCT02269852|"~     The purpose of this study is to evaluate the immunogenicity and safety of Northern~     hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants~     aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged >~     60 years.~   "
60190|NCT02269358|"~     The goal of the present study is to evaluate if addition of methotrexate can restore~     remission after loss of response to infliximab after dose escalation.~      another goal is to evaluate if low dose methotrexate can maintain remission achieved by~     regular dose methotrexate by 6 months.~   "
60153|NCT02269839|"~     Tinnitus is a common problem which can have a severe impact on quality of life and for which~     there is no truly successful treatment available.~      Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain~     through the application of a magnetic field in a series of rapid pulses and may be a~     valuable treatment for patients with tinnitus.~      The overall aim of this research is to see if patients with tinnitus benefit from treatment~     with rTMS, and in particular whether one type (continuous theta burst) is more effective~     than other variations of rTMS. Prior to developing a definitive study to address this area a~     feasibility study needs to be performed.~      The proposed feasibility study aims to determine outcomes necessary to enable development of~     a definitive study in the future.~      40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control~     group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS~     on 5 consecutive days.~   "
60154|NCT02269826|"~     Vulvovaginal irritation due to dryness is a frequent complaint among post- and some~     premenopausal women. International guidelines recommend non-hormonal products as first line~     therapy.~      Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal~     vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a~     non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised,~     two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.~      The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added~     up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects~     were planned to be assessed. 120 women should be randomly allocated to either of the two~     treatments, each given over a period of 4 weeks.~   "
60155|NCT02269813|"~     PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on~     physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1~     and 2 HR-positive HER2-negative breast cancer patients. The design also provides for~     assessment of several important secondary indicators. Eligible patients will have their~     tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start~     treatment before the MammaPrint result is received and taken into consideration for the~     adjuvant treatment plan.~   "
60156|NCT02269800|"~     The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride~     Solution clearing the oral colonized bacterium in hospitalized patients with COPD.~   "
60157|NCT02269787|"~     This research program is intended to improve the treatment engagement and outcomes of~     Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and~     emergency department services. It is intended to increase the use of substance use disorder~     care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and~     reduce costs for VA.~   "
60158|NCT02269774|"~     There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk~     factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial~     fibrillation after ablation therapy. We have previously shown that simulated OSA triggers~     premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of~     atrial fibrillation are initiated by PABs. However, the origin of PABs induced by~     intra-thoracic pressure swings is unknown. This study investigates the origin of premature~     atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep~     apnea in patients with atrial fibrillation.~   "
60159|NCT02269761|"~     Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the~     Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating~     patients with shortness of breath and often provides the timely diagnosis of pneumonia,~     pneumothorax, pulmonary edema, among other primary diseases of the lung. There are~     limitations with chest radiograph such as large body mass (e.g, obesity) and patient~     positioning. On occasion, chest radiography findings are difficult to interpret. Lung~     ultrasonography may offer a means of clarifying ambiguous results.~      The objective of this study to determine the usefulness of point of care lung ultrasound in~     evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.~   "
60160|NCT02269748|"~     The aim of this randomized-controlled clinical trial is to compare the patient morbidity and~     root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination~     with a coronally advanced flap (CAF) and tunnel technique (TT).~      The primary objective of the study is to demonstrate the superiority in terms of the~     post-operative course and pain of the CAF+SeCTG when compared to the TT.~   "
60161|NCT02269735|"~     The purpose of Part I of this study is to evaluate the safety and tolerability of~     intravenous (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma~     pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to~     evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI),~     and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in~     participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I~     general safety, tolerability and other observed data are supportive of progression to Part~     II. Part III will be initiated only if Parts I and II general safety, tolerability and other~     observed data are supportive of progression to Part III.~   "
60162|NCT02269722|"~     The investigators will assess the effect of different times of radial clamp post procedure~     on radial artery occlusion and bleeding.~   "
60163|NCT02269709|"~     The purpose of this study is to distinguish between the impacts of congestion and fibrosis~     on liver stiffness in post-Fontan operation pediatric patients using a new form of~     ultrasound (Acoustic Radiation Force Impulse (ARFI) elastography)~   "
60164|NCT02269696|"~     The purpose of the study is to test the effects of metoprolol on anaesthesia and the need~     for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up~     the incidence of pain and life satisfaction will be evaluated.~   "
60165|NCT02269683|"~     The present randomized controlled trial evaluates the incidence of R1 resections in patients~     undergoing robotic distal pancreatectomy compared to the laparoscopic technique.~   "
60218|NCT02268994|"~     a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized,~     double-blind, placebo-controlled period (Randomized Period), followed by an 8-week~     open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate)~     (Extension Period).~   "
60166|NCT02269670|"~     This phase II trial studies how well everolimus and hormone therapy work in treating~     patients with hormone receptor positive breast cancer that has continued to spread~     (progressed) or returned after a period of improvement (recurred) on everolimus and~     exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and~     progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy~     may fight breast cancer by lowering the amount of estrogen and progesterone the body makes.~     Giving everolimus with a different type of hormone therapy may be an effective treatment for~     breast cancer in patients who progressed on everolimus with exemestane.~   "
60167|NCT02269657|"~     The EOS® imaging system, a new imaging modality which offers low dose, weight bearing and~     full body X-ray imaging, requires a new standing position where patients put their hands and~     forearms on the wall vertically for stability. Although this method provides enough support~     for the patients during the extended X-ray acquisition time, its impact on the postural~     balance and sagittal profile of the spine and sacro-pelvic parameters has not been~     evaluated. The goal of this study is to identify the impact of patients' arm positioning on~     the sagittal profile and postural balance of the patient and subsequently propose a~     standardized method for full spine X-ray acquisition in the EOS® imaging system.~   "
60168|NCT02269644|"~     This study will be a double-blind, randomized, multicenter trial to assess the safety and~     efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of~     azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12~     hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of~     Community Acquired Bacterial Pneumonia.~   "
60169|NCT02269631|"~     This pilot study is designed to test the effects of a high legume (dried bean) diet on~     hunger and other indicators of health over the course of eight weeks, compared to a more~     conventional healthy diet.~   "
60170|NCT02269618|"~     The aim of this randomized control study is to determine the feasibility and efficacy of an~     innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease~     (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the~     study and followed for 4 months and for additional 2 months of follow-up. The primary~     outcome is to improve tolerance capacity~   "
60171|NCT02269605|"~     Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal~     is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1~     infected patients receiving antiretroviral treatment.~   "
60172|NCT02269592|"~     Blood cancers occur when the molecules that control normal cell growth are damaged. Many of~     these changes can be detected by directly examining parts of the cancer or cells in blood.~     Several alterations that occur repeatedly in certain types of blood cancers have already~     been identified, and these discoveries have led to the development of new drugs that target~     those alterations. More remain to be discovered.~      Some of these abnormalities include alterations in genes. Genes are the part of cells that~     contain the instructions which tell the investigators bodies how to grow and work, and~     determine physical characteristics such as hair and eye color. Genes are composed of DNA~     letters that spell out these instructions. Studies of the DNA molecules that make up the~     genes are called molecular analyses. Molecular analyses are ways of reading the DNA~     letters to identify errors in genes that may contribute to an increased risk of cancer or to~     the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others~     occur in the genes that are passed from parent to child. This research study will examine~     both kinds of genes. The best way to find these genes is to study large numbers of people.~     The investigators expect that as many 1000 individuals will enroll in this study.~      This research study is trying to help doctors and scientists understand why cancer occurs~     and to develop ways to better treat and prevent it. To participate in this study the~     participant must have cancer now, had it in the past, or are at risk of developing cancer.~     The participant will not undergo tests or procedures that are not required as part of their~     routine clinical care. The investigators will ask the participant to provide an additional~     sample from tissue that is obtained for their clinical care including blood, bone marrow, or~     tissue sample. The investigators will also ask for a gentle scrape of the inside of their~     cheek, mouthwash or a skin sample to obtain their germline DNA~   "
60173|NCT02269579|"~     To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin~     pharmacokinetics and their metabolites following administration of CPX-351.~   "
60174|NCT02269566|"~     We will perform double-blinded placebo-controlled randomized clinical trial which evaluates~     the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for~     allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat,~     and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic~     rhinitis.~   "
60175|NCT02269553|"~     The study is an open-label, prospective, multi-center, randomized, two treatment parallel,~     comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the~     reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed~     with sleep bruxism and headaches.~   "
60176|NCT02269540|"~     The investigators will be looking at MAO-A density before and after seven weeks of treatment~     with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain~     chemicals that regulate mood. MAO-A density is elevated in patients with major depressive~     episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant~     with common antidepressant treatments and we think it may be due to poor targeting of brain~     pathologies. We want to test if adding a dietary supplement may normalize MAO-A.~   "
60177|NCT02269527|"~     The use of live music in SICU might affect the perception of noise, which may reduce staff's~     stress level and further decrease the possibility of clinical errors, reduce patient's~     anxiety and perception of pain as well as increase compliance from patient and family. Live~     music might also enhance the quality of stay and promote a holistic healing process for the~     patient.~   "
60178|NCT02269514|"~     The purpose of this study is to measure plasma nicotine uptake parameters, physiological~     measures, and subjective effect measures in smokers during and following a single ad libitum~     use of three electronic cigarettes versus combustible cigarettes and nicotine gum.~   "
60179|NCT02269501|"~     The purpose of this study is to study the effect of a physical exercise program on patients~     suffering from migraine and co-existing tension-type headache and neck pain. The~     investigators hypothesized that migraine patients are ofte physically inactive because of~     their headache and that they will benefit from a specific exercise program.~   "
60180|NCT02269488|"~     This open-label, single arm, multicenter study will enroll approximately 100 subjects. The~     study is designed to gather the safety and tolerability data in Japanese children 2 to 6~     years of age that would support approval of MEDI3250 in Japan.~   "
60181|NCT02269475|"~     The study is designed to gather the efficacy, safety and tolerability data in Japanese~     children 7 to 18 years of age that would support approval of MEDI3250 in Japan.~   "
60182|NCT02269462|"~     Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented~     with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis~     (PEP). However, the pharmacokinetics of certain ARVs is associated with marked~     inter-individual variability. This variability has been associated with single nucleotide~     polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and~     transcriptional regulators. Pregnancy is also associated with additional changes in~     pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have~     serious consequences for virological control, MTCT, emergence of drug resistance, and~     toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is~     believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT).~     However, such exposures may also result in toxicity. For example, efavirenz is~     contraindicated in children less than 3 years old or 10kg but transferred to breastfed~     babies through breast milk. On the other hand, double exposure to nevirapine from breast~     milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity.~      In the proposed study, the influence of selected SNPs in certain drug disposition genes on~     the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as~     the level of infant exposure to both drugs through breast milk, will be studied.~     Mathematical models will be developed to predict potential dose optimisation strategies~     during pregnancy, and to predict infant exposure to maternal drugs through breast milk.~   "
60183|NCT02269449|"~     The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr~     sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr~     sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).~   "
60184|NCT02269436|"~     This is an open-label, follow-on phase 1 study to assess the long-term safety and~     tolerability of continuous i.c.v administration of 4 μg sNN0029/day in patients with ALS who~     previously participated in study sNN0029-003~   "
60185|NCT02269423|"~     The purpose of this study is to test how safe the vaccine is in humans and how well it makes~     the human immune system cause an immune- or defense-response to Ebola virus. This vaccine~     will be studied at different doses.~   "
60186|NCT02269410|"~     The obesity epidemic has grown rapidly in the United States, and is associated with~     increased morbidity and mortality rates. Bariatric surgery (BS) has emerged as the most~     effective treatment for severe obesity. Surgical weight loss (WL) is very significant~     (~40-50kg) during the first 6-12 months after surgery. The adequate amount of dietary~     protein during the active period of surgical weight loss is not known. Dietary protein~     affects body weight regulation: satiety, thermogenesis, energy efficiency and body~     composition. During diet-induced energy-restriction, sustaining protein intake (PI) at the~     level of requirement (0.8g /kg ideal body weight (IBW)/ day) appears to preserve fat free~     mass (FFM) during active WL. PI above requirements (1.2g protein/Kg IBW/ day) results in~     favorable body composition changes, with greater decrease in fat mass and preservation of~     FFM, but without effecting WL. Dietary PI 0.8g/day has been associated with greater satiety~     and increased energy expenditure (EE) during calorie restriction. In this randomized~     prospective study, the investigators will evaluate the effect of PI on nitrogen balance,~     body composition, EE and satiety in 40 women undergoing either Gastric Bypass or Vertical~     Sleeve Gastrectomy, assigned to high protein supplementation (PRO-S), high PRO-S (1.2g /kg~     IBW/day) or standard- based current guidelines -PRO-S (0.8g /kg IBW/day). PRO-S will be~     supplied for 3 months after surgery. Outcome measures including nitrogen balance, body~     composition changes and satiety will be assessed at pre-surgery, and at 3, 6 and 12 months~     post-surgery. These results will help provide evidence-based data on safe and optimal levels~     of protein supplementation after BS~   "
60187|NCT02269397|"~     The primary goal of this observational study is to establish the accuracy of CNS-specific~     Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The~     target population is patients who have been newly referred to the Penn Epilepsy Center or~     patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an~     epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to~     allow the study team to collect information from their medical record, and to provide at~     least one blood sample.~   "
60188|NCT02269384|"~     The prevalence of chronic pain has been estimated at 30% in the US and these values may~     under report the true prevalence of people who experience long term pain as additional~     research has shown that 73% will have a reoccurrence of symptoms within 12 months of the~     original injury indicating that while the pain and symptoms may resolve, additional~     impairments or issues may underlie the symptoms.~      Biopsychosocial factors such as depression, post traumatic stress, anxiety, pain~     catastrophizing, and negative emotions have been closely linked to pain and can influence a~     patient's pain perceptions. Along these lines, the memory of past experiences and trauma~     potentially play a large role in these biopsychosocial responses. Research is evolving and a~     strong correlation has been established between chronic pain and prior history of trauma or~     abuse and also non-traumatic incidents such as motor vehicle accidents and injuries/surgical~     procedures. This has led to speculation and research that explores how a variety of life~     events may become stimulants for long-term alterations in the processing and manifestation~     of pain and how they may have an enduring impact on physical health outcomes.~      The proposed research will add to the body of knowledge underlying the association between~     pain, memory, autonomic system, and neuromuscular function. The goal of this project is to~     study the relationship between pain memory systems, specifically acute pain, short-term~     memory of pain, and long term pain memory, and their effects upon neuromuscular and~     autonomic system responses in the body.~   "
60189|NCT02269371|"~     Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of~     care weight loss intervention for treatment of obesity will be recruited. Subjects will be~     randomized into one of two groups receiving either a standard of care weight loss~     intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control~     Point/Hunger Point or receiving a standard of care weight loss intervention plus sham~     auricular acupuncture. Subjects will receive treatment in accordance with their~     randomization group for 12 weeks then have one additional follow up visit at week 24. The~     following measures will be obtained: height, weight, waist circumference, and Body Mass~     Index will be calculated.~   "
60219|NCT02268981|"~     This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to~     a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.~   "
60191|NCT02269345|"~     The investigators propose to complete a randomized controlled trial to compare battlefield~     auricular acupuncture at five points in right ear and five points in left ear (cingulate~     gyrus, thalamus, omega 2, point zero, and shen men) plus standard of care, versus standard~     of care alone, for symptomatic treatment of stent pain in postoperative ureteral stent~     patients. Male and female DoD beneficiaries ages 18 years or older, who are scheduled for~     elective urologic surgery that would be expected to have the routine placement of a ureteral~     stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone,~     ESWL of stone greater than 10mm) will be recruited. Subjects will be followed up at 24 hours~     post surgery, 48 hours, 1 week, 1 month, and 1 month post surgery. The investigators will~     ask subjects to rate their pain level on a 0-10 analogue scale, the investigators will~     assess via the Ureteric Stent Symptoms Questionnaire (USSQ) subjects' urinary urgency,~     urinary frequency, and quality of life. The investigators will ask subjects how many pills~     they have taken for their pain including the quantity and dose to assess a reduction in pain~     medication use.~   "
60192|NCT02269332|"~     The investigators will recruit DoD beneficiaries 18 years or older, that have been referred~     for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have~     no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to~     determine if there is an association between the level obtained and findings on colonoscopy,~     or previous findings (if repeating).~   "
60193|NCT02269319|"~     The purpose of this study is to determine whether MRX-I is as safe and effective as~     Linezolid in the treatment of adult patients with acute bacterial skin and skin structure~     infections~   "
60194|NCT02269306|"~     The purpose of this study is to determine whether Visceral fat area and other criteria~     assessed during initial screening could predict the response to ovulation induction with~     clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).~   "
60195|NCT02269293|"~     The purpose of this study is to test the safety of the investigational drug, selinexor~     (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel~     will be given at two different dosing schedules and selinexor will be given at two different~     dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the~     treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or~     endometrial cancer. The investigators want to find out what effects, good and/or bad,~     selinexor has on the patient and the cancer.~   "
60196|NCT02269280|"~     The goal of this clinical research study is to compare how 2 different drugs, decitabine and~     azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS.~     The safety of each study drug given on these schedules will also be studied.~   "
60197|NCT02269267|"~     This is a non-randomized, prospective, single-group longitudinal study. The purpose of this~     study is to improve the decision making process used by physicians and patients when they~     are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.~   "
60198|NCT02269254|"~     The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported~     excellent medium and long-term results in clinical studies and in implant registries all~     around the world. As a follow-up of the NexGen TKR, an improved design has recently been~     introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used~     successfully in about 20.000 patients, but results from independent clinical studies have~     not been reported yet.~      The objective of this study is to accurately assess and compare migration, kinematics,~     prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing,~     cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed~     bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer,~     Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two~     TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and~     compare clinical data, kinematics, prosthesis placement and patient reported outcome~     measures.~      This study is designed as a single-blind randomized trial between the Persona PS total knee~     prosthesis and the well-established NexGen total knee prosthesis.~      Different sample sizes are used for the different parts of this study:~        -  30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for~          RSA~        -  15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for~          Fluo~      The study population will consist of patients with symptomatic osteoarthritis of the knee~     scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical~     Center. Annually 40 TKA procedures are performed in our department, of which about 70% is~     Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be~     accomplished within a 2 year period.~      Main study parameters/endpoints are:~        -  Migration, measured by means of RSA.~        -  Prosthesis placement and bone resection measured by means of CT and caliper~          measurements of the resected bone parts.~        -  In vivo kinematics by means of fluoroscopy.~        -  Patient Reported Outcome Measures by means of questionaires.~   "
60199|NCT02269241|"~     To demonstrate the contraceptive efficacy of LF111. To demonstrate the safety and~     tolerability of LF111 and assessment of pharmacokinetics of LF111.~   "
60200|NCT02269228|"~     To investigate the occurrence of dipyridamole associated headaches in healthy subjects using~     a titration scheme or not~   "
60201|NCT02269215|"~     Safety, tolerability and pharmacokinetics of BIII 890~   "
60202|NCT02269202|"~     To assess the pharmacokinetics of midazolam with/without concomitant administration of~     crobenetine~   "
60203|NCT02269189|"~     Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)~   "
60204|NCT02269176|"~     Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the~     treatment of the mild to moderate primary hypertension patients in China~   "
60205|NCT02269163|"~     A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability,~     Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous~     (Human) 10% in Adults and Children with Primary Immunodeficiency Diseases (PIDD) to assess~     the tolerability, safety, efficacy and pharmacokinetics of ProMetic's IGIV in subjects with~     PIDD. IGIV is intended for the treatment of children and adults with Primary~     Immunodeficiency Diseases (PIDD) who require IgG (Immunoglobulin G) replacement therapy~   "
60206|NCT02269150|"~     The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent~     the future development of CDI. This is also known as fecal bacteriotherapy or stool~     transplant.~   "
60207|NCT02269137|"~     To characterize the functional outcomes and prognostic factors for convulsive status~     epilepticus (SE) and to further develop and validate a simple and practicable scoring system~     for outcome prediction.~   "
60220|NCT02268968|"~     The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on~     reducing pain associated with the application of nasal CPAP in preterm infants~   "
60221|NCT02268955|"~     The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in~     the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous~     ibuprofen will provide a clinically significant drop in self-reported patient pain level as~     measured by the visual analog scale.~   "
60208|NCT02269124|"~     Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on~     quality of life, school performance and behavior. Despite this knowledge, it remains unclear~     how to best manage this common problem. There has been much debate regarding this issue with~     many programs recommending preferential seating in the classroom and use of a~     frequency-modulated (FM) system to amplify the teacher's voice in the classroom~     (conventional measures), and others recommending these accommodations in addition to use of~     a hearing aid for amplification (amplification). There is very limited research to support~     or refute the efficacy of a hearing aid in improving measurable academic, behavioral, or~     quality-of-life (QOL) outcomes in children with UHL. We propose a study evaluating the~     impact of hearing aid use in school-aged children (ages 6-12 years) with mild to moderately~     severe UHL. In this study, subjects will be randomized to receive either conventional~     measures or conventional measures plus amplification. After a three month period, the groups~     will be reversed, with each subject serving as their own control. Outcome measurements will~     include patient reported disease-specific QOL reported by patients, parents, and teachers~     using validated survey instruments at regular intervals throughout the study period.~   "
60209|NCT02269111|"~     This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla~     in assessing disease in patients with tumors that have spread to the brain (brain~     metastases). In addition to routine care brain imaging of the brain, this study will include~     advanced multiparametric MRI sequences to measure vascular, cellular, and molecular~     properties of the tumor. Performing extra scans during MRI provides more information about~     the metastases and may better predict treatment response.~   "
60210|NCT02269098|"~     A 4 week prospective, randomized controlled study was carried out to assess the impact of a~     care delivery intervention which focused on blood glucose (BG) management among adults with~     type 2 diabetes presenting to the Emergency Department (ED) with BG > 200mg/dL (11.1~     mmol/L). The intervention was designed by a multi-disciplinary team of ED physicians and~     nurses, endocrinologists and diabetes educators. The intervention incorporated three~     components: a guideline-based algorithm for diabetes medication management; survival skills~     diabetes self-management education (DSME); and support for health system navigation. The~     control group received usual care per the ED's policies and procedures for management of~     high blood glucose.~   "
60211|NCT02269085|"~     The goal of this clinical research study is to find the highest tolerable dose of~     carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL.~      Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease.~   "
60212|NCT02269072|"~     The proposed study is a physiologic investigation of the effects of testosterone on the~     natriuretic peptide system. The hypotheses of the study are that testosterone administration~     will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks~     in duration.~   "
60213|NCT02269059|"~     This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus~     (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that~     daily administration of a safe and well tolerated dose of MK-7680 will produce a decrease in~     HCV viral load.~   "
60214|NCT02269046|"~     The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and~     moxibustion compared with active control, on absolute and percent change from baseline in~     low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.~   "
60215|NCT02269033|"~     The purpose of this study is to assess the efficacy of a patient navigator program that~     uses a trained community lay health worker to assist Hispanic patients in utilizing cancer~     care services. This study is a two part study. The first part of the study consists of a~     retrospective data collection procedure called baseline clinical chart audit of 50~     Hispanic women over 18 years of age who have had a mammography abnormality classified as~     BI-RADS 3, 4 or 5. These data will be drawn from the study clinic's existing records and~     will serve as baseline data for subjects recruited during the course of the study. The~     second part of the study, the intervention group, involves the recruitment of 50 low-income,~     Hispanic women who receive abnormal breast cancer screening results (also classified as~     BI-RADS 3, 4 or 5) from screening services at local community health clinics. Participants~     will have significantly higher compliance rates and significantly shorter time lags and~     between an abnormal screening result, and confirmatory screening tests and commencement of~     treatment, compared to our baseline. The investigators expect at least a 12% increase in~     after-screening compliance rate and a 25% reduction in time lags in the treatment group, in~     relation to the pre-intervention baseline assessment.~   "
60216|NCT02269020|"~     The main hypothesis of this study is that it is possible to make a unilateral selective~     dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via~     the da Vinci robotic system to reduce scarring, while respecting patient safety.~      Feasibility will be assessed by two combinded criteria: 1) performance of the surgical~     procedure respecting the different stages of visualization and dissection of key anatomical~     elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the~     dissection.~   "
60217|NCT02269007|"~     Influenza is an acute respiratory disease caused by influenza viruses. There are three types~     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile~     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,~     sore throat, nasal congestion and general malaise.~      Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza~     virus had occurred four large variation, causing three world pandemic. Studies have shown~     that since 1957, most of those new variants of influenza virus started in China, which is~     recognized by the world to have high incidence of influenza. At present, trivalent influenza~     vaccines are widely used in China. They only contain two kinds of type A virus antigens and~     one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and~     Yamagata) have caused an alternating cycle in different seasons. Gradually, evolved from the~     original single lineage of influenza B virus B/Yamagata, two distinct antigenic~     lineages-B/Victoria and B/Yamagata have alternately dominated or caused a mix of popular~     lineage. These two lineages have little or nearly no cross-protection. Therefore, trivalent~     influenza vaccines may not cover the popular strains of influenza B virus, whereas~     quadrivalent influenza vaccines will help to simultaneously prevent two kinds of type A~     viruses and two kinds of type B virus.~   "
60223|NCT02268929|"~     This study is a German, prospective, multicenter, controlled, cluster-randomized,~     interventional comparative study evaluating the efficacy and benefits of integrated PDM care~     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into~     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.~   "
60224|NCT02268916|"~     The purpose of the study is to investigate if the investigators can improve physical~     activity and social participation level among Veterans with diabetes.~   "
60225|NCT02268903|"~     Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about~     75000 cases in France and a short-term mortality rate of about 10%. Death is usually related~     to an acute right ventricular (RV) failure due to the increase in right ventricular~     afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in~     case of shock. However several studies suggest that fluid expansion may worsen acute RV~     failure by increasing RV dilatation and ischemia and left ventricular compression by RV~     dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of~     fluid expansion. In a preliminary study published by our group, we showed that diuretic~     treatment in the setting of PE with RV dilatation is safe and is associated with an increase~     in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients~     with oliguria. This may be related to the decrease of ventricular interdependence and~     enhancement of both LV and RV function.~      The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide~     in patients referred for acute PE with RV dilatation compared to placebo. The combination of~     urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it~     indicates the disappearance of pre-shock symptoms and is therefore associated with a lower~     event risk. Thus, it allows early discharge of the patients from the intensive care unit.~   "
60226|NCT02268890|"~     The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug~     enters and leaves the blood and tissues over time) characteristics of bortezomib when~     administered intravenously in Taiwanese participants with multiple myeloma (cancer of the~     types of cells normally found in bone marrow).~   "
60227|NCT02268877|"~     The goal of this project is to compare the efficiency of pelvic ultrasounds performed by~     emergency medicine residents and attending physicians to the efficiency of pelvic~     ultrasounds performed by the department of radiology.~   "
60228|NCT02268864|"~     The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen~     of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12~     (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected~     participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).~   "
60229|NCT02268851|"~     This research study will be evaluating the safety and efficacy of a study drug called~     TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible~     treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle~     Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.~   "
60230|NCT02268838|"~     This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study.~     This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This~     study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and~     400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive~     single dose of the study drug under fasted condition. Following 3 days of washout period,~     subject will receive the study drug once daily for 7 days starting on the fifth day from the~     single dose administration.~      For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period~     before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed~     condition, to evaluate food effect of the study drug.~   "
60231|NCT02268825|"~     This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with~     mFOLFOX6 followed by a Phase II expansion open label, nonrandomized trial with MK-3475 at~     MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of~     advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal/appendiceal~     adenocarcinoma and biliary carcinoma) to assess response rate, clinical benefit rate,~     progression free survival and overall survival. The Phase II expansion cohort will assess~     the effect of the addition of celecoxib to patients that do not respond to combination~     MK-3475/mFOLFOX treatment.~   "
60232|NCT02268812|"~     This is an open-label, long-term, multi-centre multi-national postmarketing observational~     registry. The objective of this study is to monitor the long-term efficacy, safety,~     tolerability and quality of life outcomes associated with Prialt and other analgesics~     utilised in the intrathecal management of severe chronic pain.~   "
60233|NCT02268799|"~     The purpose of this study is to determine if there is a rise in serum high sensitivity~     troponin T (a marker for heart muscle injury) following a direct current cardioversion~     (shock therapy) used for patients with atrial fibrillation. This will help us determine if~     direct current cardioversion results in damage to the heart muscles in a sufficient amount~     to cause a rise in high sensitivity troponin T.~   "
60234|NCT02268786|"~     The purpose of the current study is to evaluate the effect of preimplantation genetic~     screening (PGS) by next generation sequencing (NGS) compared to standard morphological~     assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All~     embryos will be vitrified and a single embryo transfer (SET) will be performed with either~     screened or unscreened embryos depending on randomization.~   "
60235|NCT02268773|"~     To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole~     (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect~     on inhibition of thromboxane B2 formation~   "
60236|NCT02268760|"~     To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW~        1. In rising single doses~        2. With and without a 64 g fat breakfast at one selected dose~   "
60237|NCT02268747|"~     This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER~     inhibitor, in unresectable or metastatic skin SCC.~      HER2 expression is common in skin SCC, being reported with high rates, even if in small~     studies.~      Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it~     could be associated with the malignant phenotype. In this frame Dacomitinib could play a~     role in the increase of the response rate.~   "
60238|NCT02268734|"~     Vandetanib has been approved for patients with unresectable and/or metastatic medullary~     thyroid cancer (MTC) by the Food and Drug Administration, by the European Medicines Agency~     and, very recently, it has been licensed also by the Italian Regulatory Agency (AIFA) for~     the use in Italy. Vandetanib is an orally tyrosine kinase inhibitor (TKI) of vascular~     endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and RET~     signaling.~      Circulating microRNAs levels could be influenced by the treatment procedures and we~     hypothesize that a TKI therapy could influence the levels of circulating miRNAs as well.~      Aim of this project is to seek non-invasive molecular markers potentially useful as~     prognostic tools for metastatic MTC patients.~   "
60239|NCT02268721|"~     The research and Innovation program Food'n'Go - Empower aims to develop, test and implement~     a health technology solution for involvement and increased empowerment of elderly patients~     and their relatives. The focus is on frequent issues for this group of patients, in the~     first phase focusing on nutrition and physical activity. Later, the solution will include~     pain management, management of sleep problems, management of medication, prevention of~     confusion and coordination of the treatment and care course across sectorial borders. The~     technology is a tablet-computer, operated by the patient by means of a number of app-like~     software applications.~      The program received in the summer of 2013 one of the Capital Region OPI funding for design~     and development of the prototype, which is now ready and looking very promising. The next~     step is a pilot feasibility study testing the usability and acceptability as well as effect~     during hospitalisation and at home after discharge. The present study - Food'to'Go~     investigates the intervention in the post-discharge period.~      Aim The overall aim of Food'n'Go research- an innovation programme is to develop, test and~     implement innovative information technology solutions to increase participation and~     empowerment of older patients and their families, in relation to frequent problems during~     hospitalisation and the time after.~      The aim for the substudy Food'to'Go is to test the feasibility and efficacy of ICT-supported~     energy- and protein-enforced home-delivered main and in-between meals on older patients,~     discharged from acute hospitalisation in medical wards. Hereunder:~        -  Test the technology's relevance, suitability, acceptability and ease of use in relation~          to the target group~        -  Test the communication loop between patient and kitchen, and relatives external access~          to the related website~      Welfare and health technologies are often directed at solving problems and meeting the needs~     of society's most vulnerable groups, often not familiar with computers. We will, in addition~     to developing the technological solution, examine user-related barriers and preferences for~     health technology and try to find solutions that can increase older people's possibilities~     for using technology and achieve empowerment. The program incorporates research and~     innovation in an iterative process where research provides answers and solutions to the~     issues arising in relation to the development of the technology (innovation) and the use of~     it.~   "
60240|NCT02268708|"~     Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary~     resection in patients with COPD~      Introduction: Postoperative pulmonary complications following pulmonary resection occur in~     12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that~     COPD patients with a history of frequent exacerbations are more likely to develop~     exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators'~     among COPD patients requiring pulmonary resection and the relations between exacerbations~     history and incidence of acute respiratory postoperative complications.~      The main objective is to determine the frequency of pulmonary postoperative complications~     (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD~     patients. The secondary objectives are to determine the frequency of extra pulmonary~     postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in~     this population, as well as its relation with the risk of post-operative complications.~      Materials and Methods: This is a prospective, observational, single-center study, of~     patients with COPD hospitalized for elective thoracic surgery in the center of Thoracic~     Surgery, Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years,~     permanent airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator.~     Collected data will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire~     given to the patient during the anesthesia consultation, COPD severity scores,~     comorbidities, per operative data, postoperative complications, hospitalization and~     intra-hospital mortality.~      Perspectives: This work will provide information on the risk of postoperative complications~     in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will~     help adapting preventive care to the COPD subtype .~   "
60241|NCT02268695|"~     This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx)~     versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in~     recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while~     the other half will be treated by EXTREME regimen.~   "
60242|NCT02268682|"~     Kidney transplantation, especially living donor kidney transplant (LDKT), offers patients in~     end-stage renal disease (ESRD) 3 to 17 additional years of life and improved quality-of-life~     compared to remaining on dialysis. Unfortunately, LDKT education in dialysis centers occurs~     inconsistently, especially for minorities and those who are socioeconomically disadvantaged.~      To ensure more informed transplant decision-making, through a previous HRSA grant, Dr.~     Waterman designed the Explore Transplant (ET) education program based on the~     Transtheoretical Model of Behavioral Change. Through a previous trial, an earlier version of~     ET, delivered face-to-face with patients while they were undergoing dialysis, was shown to~     increase patients' DDKT and LDKT knowledge. However, additional research exploring dialysis~     providers' ability to integrate ET into their care revealed that multiple patient, provider,~     and system barriers limited the degree to which transplant education could be improved.~      Thus, a more comprehensive case-management program to educate patients through external~     organizations may be needed to supplement ongoing transplant education within dialysis~     centers. For this grant, the investigators propose to test the effectiveness of another~     replicable solution for disseminating ET education on a broad scale: Partnering with a large~     health insurance organization to deliver video-guided transplant education supported by~     telephone and mail. The Missouri Kidney Program (MoKP) is a state-wide organization whose~     mission is to serve and educate kidney patients, particularly those who are economically~     disadvantaged. Since MoKP subsidizes the costs of dialysis medication for low-income ESRD~     patients, they operate as an insurance company would with respect to their 1200-patient~     member group. With 900 dialysis patients currently being managed by the MoKP, the~     investigators will conduct an eight-month, group randomized controlled trial (GRCT) where~     540 patients will be randomized to receive: (1) no additional education other than from~     their dialysis center; (2) a video-guided, four-part Explore Transplant (ET) program~     delivered via the internet or mail; or (3) a video-guided ET program with discussion~     facilitated by a telephone case manager.~   "
60243|NCT02268669|"~     The conceptual hypothesis of this study is that primary angioplasty is superior to a~     combined strategy of immediate thrombolysis followed by routine angioplasty in patients with~     ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of~     the transfer of these patients.~   "
60244|NCT02268656|"~     Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after~     injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI)~     pump. Effect site concentraion of propofol start from 5 and changes the concentration as~     previous response to i-gel insertion as up and down methods~   "
60245|NCT02268643|"~     In the present study, the investigators will screen breast cancer of the Chinese women based~     on ultrasound and aim to compare the risk evaluation model of PUMCH model which was~     established by our previous work with other risk models.~   "
60246|NCT02268630|"~     This prospective observational follow-up study is designed to assess the long-term outcomes~     after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant~     (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).~      The study will not be testing any formal hypothesis.~   "
60247|NCT02268617|"~     Individuals with Dementia with Lewy Bodies (DLB) and Huntington's disease (HD) experience~     balance and walking problems that lead to falls. Treadmill walking has demonstrated~     improvements in balance and walking and fall risk in individuals with Parkinson's disease~     (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects,~     changes in gait parameters have been noted after only one treadmill training session. The~     investigators propose a pilot study to investigate the safety, feasibility, and utility to~     improve mobility and fall risk of a single session of treadmill walking in individuals with~     DLB and HD.~   "
60249|NCT02268591|"~     Aim 1: Determine whether sleep enhances learning across a range of cognitive domains in~     healthy subjects.~      Aim 2: Determine whether low-frequency transcranial stimulation (TCS) delivered during slow~     wave sleep (SWS), compared to sham stimulation, enhances learning outcomes as indexed by a~     complete neuropsychological battery of tests in epilepsy patients and healthy control~     subjects.~      Aim 3: Determine whether low-frequency TCS delivered during SWS, compared to sham~     stimulation, enhances sleep architecture associated with enhanced memory consolidation (ie.~     increased coherence of slow wave activity and increased frequency of sleep spindles).~      Aim 4. Determine whether low-frequency TCS during sleep results in a more distributed memory~     representation, as suggested by increased hippocampal-perirhinal connectivity on fMRI in~     human subjects.~      Aim 5. Determine whether the frequency of interictal activity during sleep in epilepsy~     subjects is associated with the degree of cognitive benefit conferred by SWS.~      These studies will provide critical pilot data on whether non-invasive brain stimulation~     protocols previously tested in healthy subjects can be extended to epilepsy patients for~     potentially therapeutic cognitive benefits.~   "
60250|NCT02268578|"~     Memory difficulty ranks among the most common complaints for patients with temporal lobe~     epilepsy. While these cognitive problems may affect quality of life more than seizure~     frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a~     method of safe, noninvasive, and painless brain stimulation delivering low intensity direct~     current through scalp electrodes to modulate brain activity. Several recently published~     studies demonstrate the enhancement of working memory and mood with stimulation of the~     frontal region of the brain. Furthermore, tDCS has never been reported to have induced a~     seizure. The aim of our study is to determine whether real tDCS can improve memory function~     and mood. The investigators are enrolling patients with well-controlled temporal lobe~     epilepsy who have not undergone brain surgery.~   "
60251|NCT02268565|"~     The main purpose of this study is to learn about the effects of sleep disruption (two days~     in a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and~     pain processing (your own experiences/perceptions of pain). In this research project, we are~     trying to figure out if we can change the effects of sleep disruption on inflammation, mood,~     and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2~     weeks can change how we respond to sleep disruption. For example, does the sensitivity to~     pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold~     water) change with sleep disruption, and can low-dose aspirin influence this change. We are~     also interested in seeing how inflammation changes in relation to your own perceived~     experience of pain.~   "
60252|NCT02268552|"~     An open-label, multi-part, first-in-human study of oral LMI070 in infants with Type 1 spinal~     muscular atrophy. The purpose of this study is to evaluate the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate~     the Maximum Tolerated Dose (MTD) and optimal dosing regimen of orally administered LMI070 in~     patients with Type 1 SMA.~   "
60253|NCT02268539|"~     This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein~     Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different~     ablation settings.~      AF is a common condition which causes a fast and erratic heartbeat. There are estimated to~     be 50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms~     such as palpitations, lightheadedness, chest pains, shortness of breath and fatigue.~      Catheter ablation is a technique used for the control of AF. In this procedure a catheter (a~     long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg.~     The tip of the catheter can destroy tiny sections of heart tissue that may be the source or~     trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to~     maximize success rates, as such there is currently rapid advances in technology to carry out~     this procedure.~      Different catheters exist which deliver this energy in different ways. This study uses one~     such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein~     Isolation produced by Biosense Webster. Currently this system is used in practice in the UK~     for patients with this medical condition.~      What we seek to research is when ablating what is the optimum setting to perform ablation~     at. There is currently no data to guide best clinical practice in this area.~   "
60254|NCT02268526|"~     This study is designed to test if CSJ148 can prevent HCMV replication after stem cell~     transplantation.~   "
60255|NCT02268513|"~     It has been argued that social relationships are important to health and well-being. This~     study will investigate links between social networks and cardiovascular disease risk factors~     in South Asians, the second fastest growing ethnic group in the US and one with disparate~     rates of coronary heart disease. Identifying and understanding the links between social~     networks and cardiovascular disease is key to the development and testing of family- and~     community-level prevention interventions for minorities.~   "
60256|NCT02268500|"~     A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with~     heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and~     20 patients to high dose influenza vaccine. Post-vaccine antibody measurements will be~     assessed, as well as tolerability differences between groups.~   "
60257|NCT02268487|"~     The objective of this project is to assess the occurrence of early improvement within the~     first two weeks of antidepressant treatment and to correlate this improvement with favorable~     therapeutic outcome at the end of the acute and treatment continuation phases (8 and 24~     weeks, respectively).~   "
60258|NCT02268474|"~     A single center prospective, randomized, controlled split face study comparing a 532nm KTP~     laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and~     Papulopustular Rosacea.~      Subjects will receive up to 3 laser treatments 4 weeks apart and will be followed at 4 to 6~     weeks post-final laser treatment.~   "
60299|NCT02267928|"~     Prevention and early detection of medical problems can greatly reduce health care costs, yet~     time and again, people avoid or ignore services that could help detect medical problems~     early enough to prevent or reduce the severity of potential problems. The investigators seek~     to understand whether the elicitation of symptom admission by patients can predict people's~     perceived risk of the medical condition and voluntary pursuit of medical information.~   "
83288|NCT01967212|"~     The purpose of this study is to determine whether swallowing training combined with~     game-based biofeedback is effective in the treatment of dysphagia due to stroke.~   "
60259|NCT02268461|"~     Spasticity is a common complication of stroke affecting quality of life. Spasticity involves~     exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion~     and functional control. Traditional treatments involve range of motion, medications, and~     sometimes surgery. Each of these has its own limitations, which has invited exploration of~     alternative modes of treatment. One such treatment with the potential to benefit spasticity~     is repetitive Transcranial Magnetic Stimulation (rTMS).~      The purpose of this study is to determine whether patients with upper limb spasticity as a~     consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere~     of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation~     (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper~     limb function.~   "
60260|NCT02268448|"~     The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects~     with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone~     in subjects with symptomatic atopic dermatitis.~   "
60261|NCT02268435|"~     The objective of this study is to determine the recommended dose of combination of dovitinib~     and imatinib in phase I study.~   "
60262|NCT02268422|"~     To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed~     1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount~     of drug) and that they equally both stick to the skin over 7 days of continuous wear.~   "
60263|NCT02268409|"~     Study A536-06 is an open-label extension study for patients previously enrolled in study~     A536-04 (ClinicalTrials.gov Identifier NCT01749540), to evaluate the long-term safety and~     tolerability of ACE-536 in adult patients with beta-thalassemia.~   "
60264|NCT02268396|"~     This is an open-label, multi-center study to evaluate the accuracy, reliability and~     functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI)~     dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment~     Period.~   "
60265|NCT02268383|"~     Study A536-05 is an open-label extension study for patients previously enrolled in study~     A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and~     tolerability of ACE-536 in patients with low or intermediate-1 risk MDS.~   "
60266|NCT02268370|"~     The purpose of this study is to find out how to increase the potential for achieving an~     operational cure from chronic myeloid leukemia. An operational cure is a state in which~     a person does not require further treatment, although there may be some remaining cancer~     cells. Patients would normally remain on a TK inhibitor indefinitely within a standard of~     care setting for chronic myeloid leukemia. Within this clinical trial, patients will~     discontinue their TK inhibitor prematurely. If any signs of progression are identified,~     dasatinib will be introduced.~      This research is being done because dasatinib has been shown to achieve a greater response~     in a much higher proportion of patients as compared to imatinib. Dasatinib is approximately~     300 times more potent than imatinib, and it is possible that a greater response can be~     achieved by dasatinib than by imatinib.~   "
60267|NCT02268357|"~     Randomized, placebo-controlled, double-blind, parallel group clinical trial evaluating the~     anxiolytic effects of propranolol on fear of wisdom tooth removal. It is hypothesized that,~     compared to placebo, perioperative oral propranolol reduces dental trait anxiety at 1 month~     follow-up after wisdom tooth removal.~   "
60268|NCT02268344|"~     Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for~     head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral~     hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the~     rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are~     often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost.~     Brief electrical stimulation (BES) is a novel technique that has been shown to enhance~     neuronal regeneration after injury through a brain-derived neurotrophic growth factor~     (BDNF)-driven molecular pathway. The aim of this study is to examine the utility of~     intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck~     dissection.~      Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck~     dissection including Level IIb and postoperative radiotherapy will be enrolled. Patients~     will undergo intraoperative BES after completion of neck dissection for 60 minutes~     continuously at 20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively,~     patients will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses~     shoulder pain, activities of daily living (ADLs), strength, and range of motion. Secondary~     outcomes measured will include scores on the Oxford Shoulder Score, the Neck Dissection~     Impairment Index (NDII), and the University of Washington Quality of Life (UW-QOL) score.~     Primary and secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months~     postoperatively. Study and placebo groups will be compared using a Mann-Whitney analysis.~   "
60269|NCT02268331|"~     This cluster randomized trial will be the first to specifically evaluate passive versus~     active surveillance methods collection of adverse events (AEs). The evaluation of these~     methods will be performed within the chiropractic healthcare profession, specifically among~     those who treat children. To date there is no mandatory reporting and learning as part of~     their profession. In Europe, a passive (voluntary) reporting and learning online system~     (CPiRLS) has been created and will be utilized in this study for the passive reporting and~     learning arm.~      Manual therapy is the most common intervention provided by the chiropractic profession and~     is the most commonly sought provider-administrated complementary and alternative therapy in~     the United States pediatric population. This study will randomize participating doctors of~     chiropractic who often treat children, to of one of two arms (active vs. passive reporting~     and learning) to evaluate the quantity and quality of AE data collected.~   "
60270|NCT02268318|"~     INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT~     STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS~     WITH HIGH LDL-C.~   "
60300|NCT02267915|"~     1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or~          partial response with the (R-GemOxD)-induction therapy~        2. Secondary endpoints:~             1. Quality of response obtained after subcutaneous Rituximab maintenance.~             2. Progression-Free Survival (PFS)~             3. Overall Survival (OS)~             4. Time to Next Therapy (TTNT)~             5. Value of MRD in the disease outcome~             6. Toxicity~   "
60271|NCT02268305|"~     The investigators are studying whether MSM plus standard of care naproxen improves symptoms~     of lower back pain compared to standard of care naproxen plus placebo. Subjects will be~     randomized into 1 of 2 groups. Group 1 will take by mouth 6000 milligrams (mgs) of MSM plus~     standard of care naproxen. Group 2 will take by mouth placebo capsules plus standard of care~     naproxen. Subjects will be instructed to take their study pills for 12 weeks and record on a~     study diary. They will then be followed up for one final visit 4 weeks later. RMDQ, PIQ-6,~     pain level, comprehensive metabolic panel (CMP), complete blood count (CBC) will be assessed~     at 4 week intervals for 12 weeks. Subjects' participation will last 16 weeks.~   "
60272|NCT02268292|"~     The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program.~     All participators underwent an indoor bicycle exercise for twelve weeks. In addition to~     demographic data and biochemical tests were determined after an overnight fasting. Extension~     of muscle strength was detected in the dominant lower extremity.~   "
60273|NCT02268279|"~     Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and~     intravenous) in children ages 0 to 17~   "
60274|NCT02268266|"~     Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of~     vital parameters. The device is already CE marked and, for the purposes of the study, will~     be used in accordance with the intended use (after-market clinical investigation).~   "
60275|NCT02268253|"~     This is a non-randomized open label multi-center study. Patients with high-risk~     myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic~     hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia~     [CMML]) will be treated with SL-401, which will be administered as a brief intravenous~     infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for~     cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of~     SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 4~     myeloproliferative malignancies: SM, PED, MF, and CMML. In entirety, the Stage 2 portion~     will consist of up to 72 patients who will be treated at a maximum tolerated dose or maximum~     tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage~     1).~   "
60276|NCT02268240|"~     The proposed study is a pilot randomized trial of a stepped collaborative care intervention~     designed to decrease post-concussive symptoms and improve post-injury functioning among~     sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms~     (symptoms persisting at least two months post-injury) will be recruited from Seattle~     Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and~     assent will be obtained in-person. Participants will be randomized to receive either the~     stepped collaborative care intervention, or treatment-as-usual. Participants will be~     assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1~     month, 3 months, and 6 months after enrollment. The primary hypothesis is that the~     intervention group athletes, when compared to usual care control group athletes, will~     demonstrate clinically and statistically significant reductions in postconcussive, anxiety,~     and depressive symptoms over the course of the 6-month study. Secondary analyses will assess~     the impact of the intervention on functional impairment including missed school days and~     other academic outcomes. Exploratory analyses will examine MRI findings that are~     characteristic of postconcussive neuropathology, if available in medical record, as~     predictors of treatment responses.~   "
60277|NCT02268214|"~     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and~     effective therapy to improve glycemic control in patients with type 1 diabetes.~   "
60278|NCT02268201|"~     KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of~     the investigator would benefit from switch to a tacrolimus-based immunosuppression, will~     switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of~     patients will be observed for 52 weeks.~   "
60279|NCT02268188|"~     This pilot clinical trial studies the Harvesting Health Program in improving the diet and~     physical activity level of cancer survivors. Nutrition and physical activity classes and the~     opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and~     vegetable consumption and physical activity levels. Studying the participation rates and~     changes in participants' eating and physical activity habits may help doctors learn whether~     the program has an effect on participant lifestyle.~   "
60280|NCT02268175|"~     This study is comparing the effectiveness of enzalutamide with or without abiraterone~     acetate for men with high-risk, localized prostate cancer.~   "
60281|NCT02268162|"~     This study evaluates the value of different bronchoscopy combination for diagnosing~     peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive~     routine bronchoscopy, while one-third of participants will receive bronchoscopy combined~     with a guiding equipment and the other one-third of participants will receive bronchoscopy~     combined with two or more guiding equipments. These guiding equipments include virtual~     bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS)~     and fluoroscopy.~   "
60282|NCT02268149|"~     Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a~     single dose of prednisone~   "
60283|NCT02268136|"~     The objective ot the present study is to obtain information about safety, tolerability and~     preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of~     increasing doses in healthy male volunteers.~   "
60284|NCT02268123|"~     The purpose of this study is to determine if sperm DNA fragmentation is associated with in~     vitro fertilization (IVF) outcomes when euploid embryos are transferred.~   "
60285|NCT02268110|"~     The purpose of this study is to determine the effect of two different physiotherapeutic~     interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of~     diastasis recti in post-partum women.~   "
60286|NCT02268097|"~     The aim of this prospective, randomized study was to compare the clinical and radiological~     results of free-hand technique and resection guide technique for preparing patella~     during total knee arthroplasty.~   "
60287|NCT02268084|"~     The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in~     treating Post Traumatic Stress Disorder in Veterans.~   "
66397|NCT02188251|"~     The purpose of this study is to determine the effects of Activamp, a product containing~     gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy~     overweight adults.~   "
60288|NCT02268071|"~     The STOP-Trial is a prospective multicenter nonrandomized open study on grade I~     hypertension, performed by General Practitioners.~      The main purpose of the study is to determine the factors associated with the rate of~     patients remaining normotensive one year after stopping their antihypertensive monotherapy~     or low dose dual therapy:~        -  white coat hypertension~        -  primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure~          measurements (ABPM) /clinical measure~        -  initial blood pressure level~        -  compliance~        -  therapeutic class versus others~        -  age~        -  gender~        -  weight variation~        -  modification of lifestyle~        -  concomitant treatments and associated substances~      The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values~     <135/85 mmHg).~   "
60289|NCT02268058|"~     Concussions and headache are a significant problem for children and athletes. While headache~     generally resolves within 7-10 days; a significant proportion of children, 72-93% experience~     prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical~     view is that mild head injuries resolve with little chance of complications. However, the~     reality is quite different. Concussion in children presents with a range of severity and~     results in both short and long-term physical, cognitive, emotional and behavioural sequelae~     known as PCS with varying times to resolution. To date there are no specific treatments for~     headache pain related to concussion. Physical and cognitive rest is the mainstay of initial~     concussion management.~      The number of children presenting to ED's with a history of concussion and headache is~     increasing. Presently there are no evidence based guidelines available to guide the medical~     team to effectively and consistently manage their headache. Our present standard of care is~     based on the CANCHILD concussion guidelines outlining the child's return to school and~     activity. Yet, our present standard of treatment is compromised and somewhat~     counterproductive if we are not treating the child's headache pain.~      Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of~     Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia~     improves the child's headache symptoms and helps with school re-entry one week post injury,~     compared to a standard care group defined as non routine administration of pain medications.~   "
60290|NCT02268045|"~     Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with~     Non Hodgkin's lymphoma The primary endpoint of the investigation is to determine if the~     response rate obtained with RXM83 combined with CHOP is non inferior to the response rate~     obtained with reference rituximab combined with CHOP The present study is a non inferiority~     trial and the study hypothesis is the following: H0: pc ≥ pe + δ vs. H1: pc < pe + δ where,~     pe: proportion of successes in the experimental group (RTXM83+CHOP) pc: proportion of~     successes in the control group (Reference Rituximab+CHOP) Type I error: the difference pc-pe~     is less than δ when in fact the difference is greater than or equal to δ ie, the~     investigators choose the experimental treatment when the control treatment is actually~     substantially better.~      Type II error: the difference -pe is greater than or equal to δ when it is actually lest~     than δ ie, the investigators choose the control treatment when the experimental treatment is~     essentially just as good.~   "
60291|NCT02268032|"~     Evaluate the effect of continuous administration of DHEA or other androgenic agents on~     ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral~     follicle count and AMH concentrations.~   "
60292|NCT02268019|"~     A comparison between the two hemostatic methods of hypospadias repairing operation, in terms~     of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture~     needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group~     B) tourniquet application in children~   "
60293|NCT02268006|"~     RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated~     radiation therapy) allows shaping the dose around planning target volume with better sparing~     of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher~     dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total~     treatment time with potentially better response to treatment. In advanced rectal~     adenocarcinoma excellent response to preoperative radiochemotherapy with complete~     eradication of the primary tumor observed in the histopathological specimen (pathological~     complete response, pCR) correlates with a favorable overall prognosis, so trying to achieve~     better response to preoperative treatment with higher pCR seams feasible.~      PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally~     advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22~     daily fractions concomitant with capecitabine results in an improved pCR rate from 9%~     (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging~     rate, histopathological R0 resection rate, sphincter preservation rate, perioperative~     surgical complication rate, local control, disease-free survival (DFS), overall survival~     (OS), late toxicity and quality of life.~   "
60294|NCT02267993|"~     In this single-center, randomized, open-label, crossover, prospective clinical trial, a~     total of 120 AML patients who achieved remission will be randomized into two groups, of 60~     cases in each group. Each subject is required to undergo two cycles of chemotherapy. At the~     treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle,~     rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and~     renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events~     associated with rhTPO treatment are recorded during the study period.~   "
60295|NCT02267980|"~     The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as~     an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery~     times during electroconvulsive therapy (ECT) in patients with major depression.~   "
60296|NCT02267967|"~     a multicenter, open-label phase Ib study to determine the safety, tolerability and~     preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine~     tumors~   "
60297|NCT02267954|"~     The investigators aim to discover if people of different demographic levels are more or less~     attentive to changes in calorie information vs. changes in price information on a restaurant~     menu. The investigators will record whether the calorie/price change was noticed or not, as~     well as how quickly the calorie/price change was noticed, depending on condition and~     individual differences.~   "
60298|NCT02267941|"~     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese~     patients.~   "
60303|NCT02267876|"~     The purpose of the study is to assess the cumulative disease detection of greater than or~     equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical~     intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV~     status and cytology status from the BDS-USHPV baseline results~   "
60304|NCT02267863|"~     This is a phase 1b study to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT) and recommended phase 2 dose of APTO-253 HCl in patients with relapsed or~     refractory hematologic malignancies.~   "
60305|NCT02267850|"~     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light~     Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a~     double-blinded RCT with half the patients receiving treatment from a sham non-functional~     device, serving as controls, and the other half receiving light therapy treatment from a~     functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are~     compared to that of the OrthoPulse™ patients.~   "
60306|NCT02267837|"~     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light~     Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.~   "
60307|NCT02267824|"~     The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED~     (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete~     orthodontic alignment.~   "
60308|NCT02267811|"~     The purpose of this investigation is to evaluate the clinical effectiveness of the~     OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, and for~     investigators to evaluate the product in a clinical setting.~   "
60309|NCT02267798|"~     Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The~     relationship between intensity of rehabilitation and clinical outcomes, recently emphasized,~     has generated a great interest for technological high-intensity interventions. However,~     their effects compared to traditional interventions as well the involved biological~     mechanisms remain uncertain. The present Strategic Program aims to predict the treatment~     efficacy in specific rehabilitation profiles, to improve the use of targeted therapies and~     the individual management of patients affected by stroke and to transfer these findings into~     rehabilitative strategies.~   "
60310|NCT02267785|"~     The aim of this application is to compare and elucidate the effects of skill-based versus~     aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function~     (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will~     result in the greatest improvement in EF and lead to modification of underlying neural~     substrates.~   "
60311|NCT02267772|"~     Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce~     the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal~     adverse effects compared to opioids.~      Design: This is a comparative effective trial that is a randomized, controlled trial of IV~     acetaminophen vs. IV morphine in pregnant women.~      Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV~     acetaminophen or IV morphine. The IV acetaminophen group will get up to four standard doses~     of IV acetaminophen during their stay at the hospital. The second group will get up to six~     standard doses of morphine. Subjects will complete a pain scale after medication~     administration and will be asked about any side effects.~   "
60312|NCT02267759|"~     McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation,~     thereby reducing intubation time and complications, especially in patients with a difficult~     airway. This study was performed to investigate whether McGrath videolaryngoscopy is~     superior to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal~     airways, as judged by the time to intubation and ease of intubation.~   "
60313|NCT02267746|"~     The purpose of this study is to compare the safety and therapeutic equivalence of a generic~     tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the~     treatment of acne vulgaris.~   "
60314|NCT02267733|"~     A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing~     schedule for patients with monoclonal gammopathies stratified by disease status~   "
60315|NCT02267720|"~     The aim of this research is to investigate the survival rate and cost effectiveness of two~     brands of GIC as occlusal-proximal ART restorations. Also the survival rate of the tooth~     will be investigated.~   "
60316|NCT02267707|"~     The purpose of this study is to determine the safety and pharmacokinetic profile of~     nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who~     have cholestatic hyperbilirubinemia secondary to bile duct obstruction.~   "
60317|NCT02267694|"~     This research study is about adding Black Raspberry powder to the treatment regimen of~     patients with ulcerative colitis who are currently in remission and doing well.~   "
60318|NCT02267681|"~     This study aims to compare the effects of fentanyl and alfentanil on postprocedural~     cognitive function in elective endoscopy.~      150 patients will be enrolled in the study. Patients meeting eligibility criteria will be~     randomly allocated to three groups.~      The patients in Group A will be given propofol and alfentanil. The patients in Group F will~     be given propofol and fentanyl. Group P is designated as the control group and the patients~     will be given propofol for sedation.~      Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient~     and endoscopist satisfaction will be evaluated.~   "
60319|NCT02267668|"~     The study will monitor outcomes of two interventions to develop a best practice in the~     treatment of mild Traumatic Brain Injury (mTBI).~   "
60320|NCT02267655|"~     The objective of this exploratory study is to examine the utility of high resolution~     computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as~     a function of short term a) iNO administration and b) nitric oxide (NO) cylinder~     concentration using the investigational medical device INOpulse® DS-C in subjects with WHO~     Group 3 PH associated with COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH~     associated with Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2)~   "
60321|NCT02267642|"~     To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered~     intravenously in patients with active psoriatic arthritis.~   "
62814|NCT02235064|"~     The purpose of this project is to assess the effectiveness of preventative antidepressants~     immediately following delivery on postpartum depression rates in women at high risk due to~     prior history of depression or postpartum depression.~   "
60322|NCT02267629|"~     This research study tests whether GLYX-13 - an experimental drug that acts on a brain~     receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment~     study. Results from this study will allow doctors and researchers to better understand if~     you and others with OCD may respond to a class of medications that target the NMDA brain~     receptor.~   "
60323|NCT02267616|"~     This study will evaluate LNG-IUD and ENG implant users who are willing to use their~     contraception beyond the end of the FDA-approved duration. Implant users will also be~     offered to participate in an arm of the study that will randomize them to either keeping~     their implant in or have it removed and replaced with a new implant. Participants will be~     followed for up to three years.~   "
60324|NCT02267603|"~     This phase II trial studies how well pembrolizumab works in treating patients with Merkel~     cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to~     other parts of the body. Pembrolizumab may stimulate the immune system to identify and~     destroy cancer cells.~   "
60325|NCT02267590|"~     Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in~     Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.~   "
60326|NCT02267577|"~     The research team has developed an automatic blood pressure monitor to be used for the~     monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource~     settings where current monitoring is limited.~      90 adult volunteers will be enrolled by researchers at Rice University. The participant will~     be seated in a comfortable chair with arm at heart level. Arm circumference will be measured~     and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood~     pressure measurements will be taken by a commercially available device and by test monitor.~     Blood pressure measurements from both devices will be recorded. The participant's blood~     pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each~     measurement.~      The results of this study will be used to optimize the blood pressure detection algorithm~     and thus further develop the device.~   "
60327|NCT02267564|"~     This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL)~     reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.~   "
60328|NCT02267551|"~     The objective of this study is to determine whether a group of resident physicians otherwise~     naïve to robotic surgery can demonstrate equal levels of proficiency during their first~     robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer~     or the daVinci Skills Simulator.~   "
60329|NCT02267538|"~     Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery.~     Its occurrence is associated with worse outcomes of patients, including increased morbidity,~     prolonged hospital stay, increased medical cost, and higher mortality. It is also associated~     with long-term cognitive decline and decreased quality of life. However, until recently,~     pharmacological interventions that can effectively prevent its occurrence are still limited.~     The purpose of this study is to investigate whether perioperative dexmedetomidine use can~     decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.~   "
60330|NCT02267525|"~     Study 0099 (www.gastroparesisstudy.com) explores the efficacy and safety of multiple doses~     of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic~     gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for~     approximately 12 weeks of therapy. In addition, the study will be used to evaluate the~     psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported~     outcome (PRO) measure.~   "
60331|NCT02267512|"~     To investigate the efficacy and safety of ATG-F induction regimen using a single dose of~     ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.~   "
60332|NCT02267499|"~     The study involved Information and Communication Technologies (ICT) and more specifically~     computer exercises blended with game activities. It was hypothesized that ICT facilitated,~     game blended combined cognitive and physical exercise improves global cognition when~     compared to a control group; and that the number of sessions within exercising participants~     predict cognitive benefits. In addition, we explored the impact of potential moderators on~     combined exercise-induced cognitive benefits.~   "
60333|NCT02267486|"~     Examine the construct validity, the group discriminant ability, and the inter-rater~     reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate~     for the evaluation of patients with Alzheimer Dementia (AD)~   "
60334|NCT02267473|"~     Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6~     months at study start will be monitored once yearly for kidney function changes within their~     routine outpatient visit. Therefore urine samples will be collected and some additional~     blood test will be done within the routine blood sampling.~   "
60335|NCT02267460|"~     Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by~     degree of penile curvature and then randomized in a 1:1 ratio to one of the following~     treatment groups:~        -  AA4500 with investigator modeling~        -  AA4500 without investigator modeling~      Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72~     hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles.~      Approximately 14 days after the second injection of AA4500, each subject will visit the~     study site and the investigator will assess the subject and instruct the subject on~     appropriate use of the ErecAid® Esteem® Manual Vacuum Therapy System.~   "
60336|NCT02267447|"~     The purpose of this study is to develop, evaluate, and apply a predictive algorithm for~     assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool~     (CVDPoRT).~   "
60361|NCT02267122|"~     The patients were randomized into 3 groups: those patients undergoing a ionic~     silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment~     application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the~     surgical wound after finishing an elective colorectal surgery.~   "
60362|NCT02267109|"~     Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is~     impossible for someone to get an Ebola infection from this vaccine.~   "
60337|NCT02267434|"~     Study AFF011 is a randomized controlled parallel Group phase I study to investigate the~     safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with~     early Parkinson's disease.~      In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo~     group), each consisting of 12 patients. The patients will be randomized to either receive~     15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without~     active component (Placebo). Over a study duration of 52 weeks, the study participants~     receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization~     36 weeks after the first injection. Male and female patients aged 45 to 70 years can~     participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.~      AFF011 is part of a project SYMPATH funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).~   "
60338|NCT02267421|"~     Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised~     exercise training has been shown to be an effective intervention to remedy this, there is~     currently no data on home based exercise interventions in this population. This study will~     evaluate the effects of a home based exercise program on the aerobic capacity of enrolled~     early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle~     thickness, and thigh muscle oxygen consumption.~   "
60339|NCT02267408|"~     Patients on warfarin but with unstable international normalized ratio (INR) will be~     recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm,~     named after the mathematician Michael Fearon), which uses historical data to estimate~     patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose~     adjustment takes effect, or to the investigators standard management Main outcome is~     improvement in time in therapeutic range.~   "
60340|NCT02267395|"~     The study will investigate if there are differences in the presence of: (1) prior injury,~     playing patterns, and physical fitness habits; (2) scapular control; and (3) cervical~     neuromuscular control and endurance deficits between musicians with and without current~     playing related musculoskeletal injuries.~   "
60341|NCT02267382|"~     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in~     vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida~     albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161~     is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect~     profile that limits the use of commonly prescribed antifungal agents for the treatment of~     recurrent yeast infections.~   "
60342|NCT02267369|"~     The overall objective of this research is to collect data for understanding whether messages~     in online environments impact fitness attitudes and behaviors. In particular, the study aims~     to experimentally examine what features of online social media - promotional messaging or~     peer networks - impact offline fitness measures (such fitness workshop enrollment and~     self-reported physical activity level). The study partners with an existing fitness program~     at a large northeastern university, which provides a 13-week fitness program for graduate~     and professional students at the university. The program begins with a university-run~     eligibility assessment of specific fitness measures for all participants, who win prizes for~     improvements in program participation and health behavior outcomes. The fitness program~     consists of semester-long series of workshops offered through the university's recreation~     department. The randomized trial constructs an online social media platform for the fitness~     program that provides a way to send either promotion health messages or messages about peer~     activities to the online community.~   "
60343|NCT02267356|"~     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in~     vivo pharmacology studies have demonstrated that VT-1161 is highly active against~     dermatophytes that cause onychomycosis . VT-1161 is highly selective for fungal CYP51, and~     data suggests that it may avoid the side-effect profile that limits the use of commonly~     prescribed antifungal agents for the treatment of onychomycosis.~   "
60344|NCT02267343|"~     The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with~     unresectable advanced or recurrent gastric cancer (including esophagogastric junction~     cancer) refractory to or intolerant of standard therapy.~   "
60345|NCT02267330|"~     The aim of this cohort study is to precisely measure patients' exposure to gonadal radiation~     during orthopaedic trauma surgery involving the acetabulum, pelvis, hip, and femur, and to~     apply these findings to a previously described and validated formula to determine the~     increased risk of future adverse health effects to the reproductive organs.~      The investigators null hypothesis is standard of care use of x-ray fluoroscopy during~     treatment of pelvis, hip, and femur fractures will not expose patients to a significant~     gonadal radiation load. Analysis of patients' intraoperative radiation doses by means of a~     previously validated formula will not display a significantly increased risk of adverse~     health events in the reproductive organs.~   "
60346|NCT02267317|"~     To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran~     for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin~     resistant (obese and T2DM) subjects.~   "
60347|NCT02267304|"~     The aim of the current study is to examine the role of the opioïd system on the cognitive~     parameters of motivation. They are embedded in a conceptual framework of motivation that~     merges decision-making and reinforcement learning theories. Every action is conceived as~     path from one state to another. The different states are associated to different values~     (positive for rewards and negative for punishments), and the different actions to different~     costs (risk, effort and delay). The tasks are designed such that the sensitivity to the~     state and action parameters can be inferred by fitting computational models.The primary~     objective is to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on cost~     accumulation slope, assessed in an effort management task, in which participants are asked~     to squeeze a hand grip during 30 seconds at varying level of effort in order to win monetary~     payoff. Secondary objectives are to characterize the effect of Morphine 0,05mg/kg and~     Naloxone 10mg on other cognitive parameters of motivation (assessed with a motivational~     battery that includes rating, choice and learning tasks).~   "
60609|NCT02263885|"~     The proposed study will evaluate the safety, and initial efficacy of using the ExAblate~     Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD~     medications in subjects who are over 30 years of age and considered medication-refractory~     with advanced idiopathic Parkinson's disease (PD).~   "
60348|NCT02267291|"~     Cardiologists and intensive care specialists are confronted daily with mechanically~     ventilated patients exhibiting cardiac failure. It is of paramount importance to understand~     the effect of mechanical ventilation on cardiac function and to interpret echocardiographic~     findings correctly in order to provide the patient with the best possible treatment to~     support cardiac and circulatory function. Currently physicians interpret echocardiographic~     findings based on studies that were performed in spontaneously breathing patients. With this~     study, the investigators intend to contribute to the understanding of cardiac physiology in~     patients needing ventilatory support, especially they aim to provide the physiological basis~     for the interpretation of echocardiographic findings in order to improve medical support~     (e.g. fluid resuscitation, vasoactive drugs, ventilation strategy) of ventilated patients~     with impaired cardiovascular function.~   "
60349|NCT02267278|"~     The goal of this clinical research study is to learn if pracinostat, when given in~     combination with ruxolitinib, can help to control MF. The safety of this drug combination~     will also be studied.~   "
60350|NCT02267265|"~     A child's early language environment is pivotal for language development. Disparities in~     early language environments contribute to the gap in school readiness between poor and more~     advantaged children. Ultimately this leads to disparities in students' school achievement~     and economic outcomes. While recent research has highlighted the value of early intervention~     for children in disadvantaged families, most existing interventions begin too late, reach~     only a small proportion of children at risk, and do not capitalize on the critical role that~     parent language plays in a child's educational trajectory. To address this challenge, the~     investigators propose to develop and evaluate a novel language-based, perinatal public~     health intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that~     new mothers will receive this educational intervention while their babies are undergoing the~     universal newborn hearing screen. The intervention will use video, animation, and~     interactive questions to convey the importance of the early language environment and to~     illustrate strategies parents can use to promote language learning. The investigators will~     conduct formative research with mothers of low socioeconomic status (low-SES) and with~     healthcare providers to inform the content and format of the intervention prototype. Also~     critical for acceptability, the investigators will use an iterative approach to develop the~     intervention, with review of the work-in-progress by the intended audience. To assess~     feasibility and initial efficacy, the investigators will conduct a randomized-controlled~     trial with low-SES mothers during the newborn period. The investigators hypothesize that~     TMW-NI will positively impact parents' knowledge and beliefs about the role of language~     input for a child's language development.~   "
60351|NCT02267252|"~     Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa~     as a possible explanation of the lower sex ratio observed after microinsemination using~     epididymal sperm from vasectomized men.~   "
60352|NCT02267239|"~     The study has the objective to compare two different methodology of application the~     antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The~     first one using the immersion in the antiseptic solution, as much of the authors did in the~     past. And the second way doing a active mouthwash, as the manufacturer recommends.~      The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine~     Perio) and the essential oils (Listerine Mentol) with the two different application and~     compared the bacterial vitality, thickness and covering grade between solutions and with a~     basal sample.~   "
60353|NCT02267226|"~     The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand~     treatment of acute bleeding in subjects with congenital fibrinogen deficiency.~   "
60354|NCT02267213|"~     The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a~     second line treatment in subjects with advanced Hepatocellular Carcinoma.~   "
60355|NCT02267200|"~     The purpose of this study is to analyse the sensitivity and specificity of circulating~     endothelial cells to predict irreversible pulmonary arterial hypertension associated with~     congenital heart disease.~   "
60356|NCT02267187|"~     This study will examine the impact of the fat grafting procedure on facial appearance and~     quality of life over time by precisely measuring soft tissue volume with CT scans, assessing~     appearance with 2D and 3D photography and standard photography and evaluating quality of~     life through various validated psychosocial measures. This study will be a very important~     evaluation of the effectiveness of this therapy, and will help guide clinicians in applying~     this technique. Additionally, laboratory testing of the injected fat material will be~     performed so that the results may be correlated with clinical outcomes in the future.~      The study endpoints include the analysis of the graft site via study procedures at different~     time points, the comparison of cotton rolling to centrifugation method of autologous fat~     grafting, as well as the correlation of cell behavior of the laboratory assays with clinical~     outcomes.~   "
60357|NCT02267174|"~     The HATRICC study will use mixed methods to implement a standardized process for operating~     room to intensive care unit handoffs that is accepted and sustainably used by perioperative~     clinicians.~   "
60358|NCT02267161|"~     The purpose of this study is to assess the neurological development at three years of age of~     children born after prenatal diagnosis of isolated agenesis of the corpus callosum.~   "
60359|NCT02267148|"~     Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting ~30% of people in~     the general population and up to 96% of obese individuals. Variations in several genes have~     been found to be associated with fatty liver, but these associations only explain a small~     percentage of the risk, and further studies are needed. In many cases NAFLD does not cause~     serious side effects, but in some individuals it progresses to scarring or hardening of the~     liver, liver failure, and cancer.~      The purpose of this research study is to determine if individuals who carry certain genetic~     variations in a gene related to bile and choline metabolism have an increased risk of fatty~     liver progressing to fibrosis, or scarring of the liver. This study will also use a new,~     non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The~     FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver~     fat measurement. However, the FibroScan® instrument is considered a non-significant risk~     device. Since its induction in Europe and worldwide in 2003, there have been no adverse~     effects reported with this device.~   "
60363|NCT02267096|"~     In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was~     reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated~     that 8 million people in the US are at high risk for lung cancer and that lung screening~     could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent~     smoking cessation programs will be essential in order to realize the full benefit of~     screening. However, there are no clinical guidelines or evidence-based cessation protocols~     with demonstrated effectiveness in this setting. The investigators are addressing this gap~     by rigorously testing whether two scalable and pragmatic interventions can significantly~     boost intention to quit and cessation rates.~   "
60364|NCT02267083|"~     This study will assess the safety and efficacy of GPX-150 administered intravenously every 3~     weeks in the treatment of patients with soft tissue sarcoma.~   "
60365|NCT02267070|"~     This is a randomized controlled 6-month trial of the efficacy of a novel intervention~     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the~     same systematic cognitive training alone. The primary treatment targets are overall~     cognitive deficit level and independent living skills. The investigators hypothesize that~     combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing~     physical exercise will produce large cognitive and functional improvements, even relative to~     cognitive training alone. Adding aerobic exercise to a cognitive training program will have~     the additional benefit of helping to ameliorate medication side effects, reduce the risk for~     developing metabolic syndrome, and help to prevent the deterioration in physical health that~     usually follows the onset of schizophrenia and its pharmacologic treatment. The~     investigators target the period shortly after a first episode of schizophrenia to maximize~     the generalization of cognitive improvement to functional outcome, before chronic disability~     is established.~   "
60366|NCT02267057|"~     The purpose of this study is to determine whether pain treatment can reduce symptoms of~     depression in patients suffering from dementia and depression. Depression is commonly~     diagnosed in patients with dementia. If the investigators find a reduction in depressive~     symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed~     pain may present itself as depression in patients with dementia.~   "
60367|NCT02267044|"~     Shoulder replacement surgery is recognized as having the potential to cause a considerable~     amount of postoperative pain. Adequate management of pain after surgery is necessary not~     only to improve the patient's wellbeing but also to facilitate recovery. Several regional~     anesthesia techniques are available to combat postoperative pain in the shoulder replacement~     surgery patient, however, which method provides superior pain relief remains unknown. The~     purpose of this study is to examine the effectiveness of a continuous interscalene block~     versus a single shot interscalene block for postoperative pain relief in the shoulder~     replacement patient.~      Patients undergoing shoulder replacement surgery will experience more effective pain relief~     with a continuous interscalene block versus and single shot interscalene block.~   "
60368|NCT02267031|"~     Abdominal surgery commonly requires perioperative relaxation and therefore controlled~     mechanical ventilation. However, respiratory support can be associated with minor, yet~     clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively~     high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient~     changes in cerebral blood flow and cognitive impair.~   "
60369|NCT02267018|"~     Preterm babies have immature lungs and frequent pauses in their breathing which often~     necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of~     the most commonly used tools, but does not always provide enough support. A new option is~     non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with~     gas exchange and may decrease a baby's work of breathing. The investigators plan to study~     very low birth weight preterm babies who are generally well but require some support with~     their breathing. By inserting a special feeding tube with sensors into the stomach, the~     investigators can measure the electrical activity of the diaphragm (EAdi), which is an~     important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV,~     the investigators will be able to measure and compare how each method of support affects a~     baby's breathing. This important study will help us determine the most appropriate breathing~     support for preterm babies.~   "
60370|NCT02267005|"~     This project will bring together a multidisciplinary team of pediatric rheumatologists,~     neurologists, metabolic geneticists and exercise physiologists to determine the effect of~     creatine (CR) supplementation on muscle function and muscle metabolism in children with~     Dermatomyositis (DM). The investigators propose using well-established exercise testing~     techniques as well as new, powerful exercise imaging protocols in order to better delineate~     the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study~     will provide information regarding the effect of creatine supplementation on muscle function~     in DM. Improvements in muscle function and fatigue through CR use may also contribute to an~     improvement in quality of life and have significant clinical implications for the treatment~     of children with DM.~   "
60371|NCT02266992|"~     Influenza ('flu) can cause severe infections, especially in people with weakened immune~     systems such as those with HIV. For this reason, yearly vaccination is recommended with the~     standard 'inactivated' influenza vaccine to try and prevent infections in these populations.~     It is also recommended in all health care workers, to help prevent the spread of influenza~     within healthcare settings. However, having HIV infection may mean vaccines work less well~     in some people and the investigators do not completely understand why. An alternative to the~     standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine'~     (LAIV), which means it consists of weakened versions of the influenza virus.~      Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into~     each nostril. It is now given to children in the UK in preference to the standard vaccine as~     it results in greater protection from influenza. In some other countries, like the USA,~     adults are also given LAIV, where it seems to work just as well as the standard vaccine. A~     few studies in the past have shown that LAIV is safe and effective in HIVinfected children~     and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals,~     to try to find out new information about how HIV infection may change the way in which~     people respond to vaccines. The investigators will do this by comparing both the early~     genetic response to the vaccines and later responses from cells specifically targeted to~     fight influenza ('Tcells'), in these groups. In the long term, the investigators hope that~     this will lead to designing new ways of improving the response to vaccines in HIVinfected~     people. As LAIV is given into each nostril, rather than an injection, the investigators also~     want to see if LAIV results in Tcells in the lung that are specifically targeted to fight~     influenza~   "
60610|NCT02263872|"~     In this double blind randomised controlled pilot trial the investigators aim to determine~     the efficacy of minocycline as an adjunct to treatment as usual in patients with major~     depressive disorder. The investigators hypothesize that the multiple neuroprotective effects~     of minocycline will lead to an improvement in depressive symptoms in participants that were~     given minocycline plus treatment as usual~   "
60372|NCT02266979|"~     As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework~     of nursing professionals is essential to ensure the safety and quality of patient care. To~     achieve such goals actions are needed to evaluate the variety of tasks and performance~     specific to each area in nursing profession. The National Agency for Health Surveillance~     (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1~     to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not~     based on any evidence, and same apply to other Latin-American countries. Objective: To~     determine the appropriate nurse: patient ratio for peritoneal dialysis unit. Method: This~     research will be developed in two phases. The first with an observational design with~     descriptive and qualitative approach. There will be a focus group with experts in the field,~     to defined the activities and responsibilities of the peritoneal dialysis nurse, and produce~     a tool with a list of activities. A time-orientated score will be created. In the second~     stage a cross-sectional quantitative approach will be used. To apply the instrument from by~     direct observation of activities performed by nurses during their workday. With the~     instrument activities will be timed and the overall time of each nursing activity will be~     determined by multiplying the time spent by the total number of patients. It is expected tat~     this strategy will increase time on treatment and/or decrease dropout rates, by developing~     an easy test/ formula application to determine the correct ratio according to the peritoneal~     dialysis program. This tool will provide better outcomes for patients as well as allow for~     growth of peritoneal dialysis programs with qualified assistance and patient safety.~   "
60373|NCT02266966|"~     The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of~     single dose of F2695 at 75mg on modulation of the cerebral motor network.~   "
60374|NCT02266953|"~     The purpose of this study is to promote optimal nutrition for the child based on the public~     health nurse's family-focused conversations at the child health centre. An image based~     communication tool is used in an intervention in order to promote dialogue and active~     participation by the parents about themes concerning food and feeding practices.~   "
60375|NCT02266940|"~     This is an open label, randomised, 3 treatment, 3 period crossover study. This study is~     designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a~     reconstituted oral suspension and the effect of a high fat meal on the relative~     bioavailability of DS 1971a from the tablet formulation.~   "
60376|NCT02266927|"~     To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440~     µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.~   "
60377|NCT02266914|"~     Magnetic Resonance Elastography (MRE) for cardiac transplant patients.~   "
60378|NCT02266901|"~     Patients presenting intra-abdominal abcesses following bariatric surgery complicated by~     fistulae are classically treated by external drainage and endoprosthesis or surgical redo.~     Morbidity and mortality being increased in case of necrotic collections, an endoscopic~     debridement treatment might be proposed in certain cases. This present study aim to review~     the evolution of the patients treated by this method from 2007 to 2011 in the investigators~     institution.~   "
60379|NCT02266888|"~     In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will~     lower the number of B cells in the body. Doctors are also trying to see if decreasing B~     cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment~     has been studied in other types of solid organ transplants.~   "
60380|NCT02266875|"~     A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline~     (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale~     scores after 4 treatments within 24 hours.~   "
60381|NCT02266862|"~     Purpose: The purpose of this study is to evaluate the location within the renal artery of~     maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR)~     using CT with end-inspiration and end-expiration CT images before and after repair. Then,~     the renal artery segment with maximal angular displacement on each will be located and any~     changes described.~      Participants: There will be 30 subjects recruited from UNC Hospitals.~      Procedures (methods): For this study, patients will receive an additional CT sequence~     (end-expiration CT), which will be compared with the standard of care end-inspiration CT to~     calculate angular displacement and the distance from the aorta.~   "
60382|NCT02266849|"~     Clinical experience show limited effect of the drug Loperamide used to decrease output in~     stoma patients. Therefore the investigators see the need for a randomized blinded clinical~     trial to determine the effect of Loperamide opposite Placebo.~      Loperamide will be evaluated in relation to the following parameters~        -  Change in ileostomy output in g/day in relation to oral intake~        -  Quantification of the change in intestinal transit time using a radiopaque marker~        -  The patient´s own assessment on which period they received Loperamide or Placebo~   "
60383|NCT02266836|"~     The purpose of this study is to examine the efficacy of MyndMove therapy in the early~     sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include~     assessing the required doses of electrical current amplitudes, the usability of the device,~     and examining the overall safety.~   "
60384|NCT02266823|"~     The purpose of this study is to pilot test an mHealth technology-supported behavioral~     intervention designed to engage patients with diabetes and concurrent chronic kidney disease~     (CKD) in multiple behaviors which aim to reduce CKD progression. Participants will be~     randomized to the 6-month lifestyle intervention or to a wait-list control. The lifestyle~     intervention will be modeled after that used in the Diabetes Prevention Program (DPP) and~     the counseling intervention will be based on SCT, which will be paired with mobile~     technology-based dietary and physical activity monitoring. The wait-list control will~     receive 6 months of standard medical care followed by a delayed, but less intensive, 6-month~     intervention.~   "
60385|NCT02266810|"~     The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini~     and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening~     following frontal sinus surgery in patients with chronic sinusitis.~   "
60386|NCT02266797|"~     This is a randomized, double-blind, placebo-controlled study to examine the effect of local~     intravenous steroids following anterior cervical spine surgery on the development of~     dysphagia in patients.~   "
60387|NCT02266784|"~     The overall goal of the study is to evaluate how motivation and readiness for change are~     influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age~     18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be~     enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20~     non-ADHD smokers will be assigned to a traditional 8-week contingency management~     intervention in which monetary payments will be made contingent upon biologically verified~     evidence of smoking abstinence. The 20 additional ADHD smokers will be assigned to a~     treatment-as-usual condition (nicotine replacement; supportive counseling). During the~     treatment phase, subjects will be required to answer questions 4x/week in their daily lives~     via an EMA (Ecological Momentary Assessment).~      Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a~     quit attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The~     investigators hypothesize that prior to a quit attempt, smokers with ADHD will exhibit~     significantly lower levels of intrinsic motivation to quit, and equal or higher levels of~     extrinsic motivation to quit compared to smokers without ADHD. Hypothesis 1b: The~     investigators hypothesize that smokers with ADHD will exhibit relatively less readiness for~     change than smokers without ADHD.~      Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change~     are influenced during a quit attempt as a function of both ADHD status and treatment~     modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result~     in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to~     quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The~     investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and~     readiness for change will be significantly influenced by the CM intervention versus~     treatment as usual among ADHD smokers.~      Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as~     usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for~     promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term~     (3-6 months) smoking cessation.~      Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD~     symptoms, and motivation to quit/readiness for change. The investigators hypothesize that~     higher levels of motivation and readiness for change will be associated with lower levels of~     self-reported withdrawal, craving, and negative affect.~   "
60388|NCT02266771|"~     The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative~     pressure wound therapy with instillation, when compared to historical controls of V.A.C~     Therapy without instillation in the management of wounds.~   "
60389|NCT02266758|"~     This project randomizes two different screening strategies for diabetes in pregnancy, among~     a study population of over 17,500 pregnant women and their babies (over 35,000 total) in a~     large diverse health maintenance organization (HMO), to determine how diagnosis and~     treatment based on these two strategies in routine clinical care affects complications for~     the baby and the mother.~   "
60390|NCT02266745|"~     This is a Phase I, open-label, multi-center, non-randomized, dose-escalation study to be~     conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase. The Dose~     Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2~     dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, PK~     (pharmacokinetic) and preliminary clinical effects. The Dose Confirmation Phase will be a~     cohort expansion at or below the MTD of PT-112 Injection. Subjects who tolerate the drug and~     who do not experience progressive disease may continue to receive PT-112 Injection at the~     discretion of the Principal Investigator for up to 6 cycles. For subjects who tolerate~     PT-112 Injection and who experience an objective response or stable disease through 6~     cycles, the Sponsor will continue to provide PT-112 Injection under a separate mechanism,~     e.g., an extension protocol.~   "
60391|NCT02266732|"~     The traditional model of localizing a nerve for blockade is using a peripheral nerve~     stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide~     nerve blockade. However despite excellent visualization nerve block success has not~     significantly improved. I aim to show that this is because the PNS stimulation of a nerve is~     more than a proximity response as thought but a correct fascial plane response and hence the~     high success rate of this blind approach.~   "
60392|NCT02266719|"~     This is an investigator sponsored Investigational Device Exemption (IDE) aimed to assess the~     use of the Custom Made Device (CMD) to repair juxtarenal aneurysms, suprarenal and type IV~     thoracoabdominal aneurysms in standard risk patients having appropriate anatomy. This study~     is a prospective, single-center, non-randomized, single-arm study.~   "
60393|NCT02266706|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a~     single intravenous dose of ceftolozane/tazobactam in pediatric participants.~      Ceftolozane/tazobactam is a novel antibacterial consisting of ceftolozane, a unique~     antipseudomonal cephalosporin, with tazobactam, a well-established β-lactamase inhibitor.~      This is the first study investigating the use of ceftolozane/tazobactam in pediatric~     participants.~   "
60394|NCT02266693|"~     This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic~     Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators~     hypothesize that patients who receive iCBT will show significant improvement in anxiety~     symptoms and functioning, compared to a wait-list group. This pilot randomized controlled~     study will assess the efficacy of transdiagnostic iCBT in 60 young adults.~   "
60395|NCT02266680|"~     The goal of this study is to determine the safety and effectiveness of Breathing Focused~     Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be~     randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life~     will be compared between the two groups before and after the 8 weeks.~   "
60396|NCT02266667|"~     The purpose of this study is to evaluate the performance of the device NEMOST on~     maintaining of the correction of the scoliosis with growth preservation and avoiding~     iterative surgeries.~      Objective of this study is to evaluate the performance of the growing device NEMOST~     associated to physiotherapy at 12 months postoperatively in patients treated for progressive~     scoliosis and to evaluate its safety.~   "
60397|NCT02266654|"~     The goal is to evaluate the best way for paramedics and hospitals to work together to treat~     septic patients as quickly as possible.~      The investigators think that the best thing to do for septic patients is to identify and~     treat them as early as possible. This research will test this. The investigators think that~     if paramedics identify septic patients and begin treatment with fluids in the ambulance,~     then the patient will do better in the long run. The paramedic will also tell the hospital~     that a septic patient will be there soon. The caregivers can prepare and be ready to provide~     care as soon as the patient arrives. With this research, the investigators would like to see~     if these steps help patient outcomes.~   "
60414|NCT02266433|"~     The primary objective of this study is to compare local corticosteroid hand and elbow~     injections to placebo or ketorolac to determine if there is an equal or better reduction of~     symptoms for common orthopaedic upper extremity disorders including: De Quervain's~     tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators~     will enroll 780 subjects, divided equally into three arms for each disease process, and~     compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring~     patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks,~     and 6 month followup periods, prospectively over time.~   "
67838|NCT02169401|"~     08-SMI-2012 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     intractable, chronic pain.~   "
60398|NCT02266641|"~     Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms~     of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic~     environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome~     molecule, to promote the individual nutrient growth factor of growth and development.~     Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of~     one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl~     metabolic nutrition environment. It not only leads to fetal growth mutation - such as folate~     and choline deficiency, increasing the risk of fetal neural tube defect but also induce~     abnormal modifying of fetuses's post-genomic methylation markers, may alter imprinted genes~     function of progenitors, recompile threshold sensitivity or domain in regulation of~     metabolic reactions of offspring, resulting in long-lasting effect, increasing the risk of~     chronic diseases of offspring such as cancer. According to the National Nutrition Survey~     results show that a considerable proportion of the Taiwanese people had poor one-carbon~     nutritional status. 48% of women intake 66% below the recommended intake reference value of~     folate. Whether inadequate parental one-carbon nutrients intake combined with genetic~     polymorphisms of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus,~     affecting fetal growth and modifying the risk of cancer development relationship of~     offspring. It is due to the lack of local ethnic data and empirical scientific reference at~     home and abroad, so it can not plan an effective maternal and children nutrient education~     and prevention strategies about methyl nutrition for early cancer prevention for Taiwanese.~     Therefore, indigenous people is the intended population of study in this project, screening~     of healthy pregnant women with high risk factor for cancer and obese pregnant women, and~     detection of one-carbon nutrient intake and biochemical assessment of the nutritional status~     of the study group. Supplying nutrition education intervention or multivitamin supplement to~     improve the poor nutritional status of persons. Using related DNA methylation imprint marker~     about offspring growth and modifying development of cancer as assessment, this project~     explores the appropriate one-carbon nutrient intake in parents and children and the~     assessments in regulation of growth and reducing the cancer-related risk.~   "
60399|NCT02266628|"~     The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine~     in elderly subjects, as well as rate the incidence of medically- attended RSV disease in~     vaccine and placebo recipients.~   "
60400|NCT02266615|"~     Collection of coded biomaterial and clinical data with patients consent for future research.~   "
60401|NCT02266602|"~     Single arm study to assess the effectiveness of single dose intraoperative radiation therapy~     in patient with in situ and early stage breast cancer.~   "
60402|NCT02266589|"~     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate~     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by~     which little doses of hydrocortisone influence coagulation system in sepsis.~   "
60403|NCT02266576|"~     The goal of the proposed research is to identify effective patient-centered strategies to~     prevent diabetes in high-risk populations in real world settings. The investigators will~     accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes~     Prevention Program addressing psychosocial stressors to a standard version in a high-risk~     population of urban American Indian and Alaskan Native peoples within a primary care~     setting.~   "
60404|NCT02266563|"~     The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood.~     Repeated concussions have been associated with an elevated incidence of Alzheimer's disease~     (AD) along with a reduced age of onset. As repetitive TBI has been studied, a syndrome has~     now been identified: chronic traumatic encephalopathy (CTE). There are growing concerns~     about the long-term neurologic consequences of head impact exposure from routine~     participation in contact sports (e.g., boxing, football). Brain autopsies of athletes with~     confirmed CTE have demonstrated tau-immunoreactive neurofibrillary tangles and neuropil~     threads (known as tauopathy). The relationship between exposure to repetitive head impact~     and the subsequent development of chronic neurodegenerative disease has not been~     established. Further, as the diagnosis of CTE (defined by the presence of tauopathy) is~     presently made after death at autopsy, clinical tools and biomarkers for detecting it remain~     to be defined.~      With the advent of FDA-approved PET amyloid imaging, clinicians and researchers are now able~     to estimate plaque density in the brains of living patients. However, there are critical~     limitations to amyloid imaging. Current evidence suggests that markers of the presence and~     severity of tauopathy may be able to address these limitations. The study will utilize both~     [18F] Florbetapir and [18F]-T807 PET imaging to investigate amyloid and tau accumulation in~     subjects with a history of concussions. In order to determine whether problems with~     cognition and memory are seen within the populations defined for the study, the researchers~     will administer a core battery of neurocognitive testing. This battery will assess cognitive~     abilities commonly affected by TBI, including processing speed, reaction time, new~     problem-solving, executive functions, attention and concentration, and learning and memory.~     These tests, in conjunction with the imaging, will be able to determine whether regional~     brain activity is associated with specific cognitive problems. The researchers will obtain~     PET and neurocognitive data in 3 cohorts: subjects with a history of TBIs, subjects with~     mild cognitive impairment (MCI) and no TBI history, and healthy controls.~      The investigators aim to determine whether individuals with TBI are on the same trajectory~     of neurodegenerative disease seen in AD or in CTE. Because of the overlap in~     clinical/cognitive and some behavioral symptoms in AD and CTE, an additional biomarker tool~     is needed to prevent misdiagnosis. Accurate diagnosis is crucial in order to provide~     patients with appropriate treatment.~   "
60405|NCT02266550|"~     The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics~     of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS~     in 6 healthy volunteers. Tolerability was also assessed.~   "
60406|NCT02266537|"~     The study was aimed to evaluate the pharmacological effect of different α-antagonists on~     phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for~     Intraoperative floppy iris syndrome (IFIS)~   "
60407|NCT02266524|"~     To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in~     children with voiding disorders~   "
60408|NCT02266511|"~     The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4~     mg capsules in healthy male subjects. One is a commercial scale batch produced at the~     Nishine facility, and the other is a batch, of equal size, produced at the Norman II~     facility~   "
60409|NCT02266498|"~     To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg~     BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules~   "
60410|NCT02266485|"~     Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker),~     effect on routine lipid profile parameters, safety and preliminary pharmacokinetics~   "
60411|NCT02266472|"~     The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing empagliflozin and metformin extended release compared to~     the free combination of empagliflozin and metformin extended release under fed conditions.~   "
60412|NCT02266459|"~     This is a prospective, open, multicenter study that will enroll patients admitted to and~     hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.~      The main purpose of the study is to evaluate the ability of the Microwave Technology to~     deliver adequate measurement data.~   "
60413|NCT02266446|"~     The purpose of the study is to develop a personalized, user-friendly computerized treatment~     for anxiety disorders linked to primary care. The computerized treatment is a type of~     Cognitive Bias Modification, which targets attention and interpretation biases known to~     maintain anxiety disorders.~   "
60611|NCT02263859|"~     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve~     stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for~     individuals with moderate to severe OSA that have failed or do not tolerate PAP.~   "
60415|NCT02266420|"~     This is a prospective, non-randomized and multicenter study designed to compare biological~     features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus~     pT1c T2 ≤ 30 mm.~      All consecutive patients will be recruited by each investigator after completion of surgery.~     No modification of standard management according to each investigator center will be done.~     All patients will then be followed each year during 5 years in order to collect the~     following events: local and loco regional recurrence, metastatasis, second cancer, death or~     not and the cause.~      At initial visit, a 10 mL blood sample will be collected (= study intervention) and~     immediately processed for serum storage; all serum samples will be stored at -80°C and may~     be used for the purpose of further scientific research.~      A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be~     addressed at the Institut Claudius Regaud for central collection which will consist of one~     haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides~     for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).~      Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli~     Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to~     detect gene copy number alterations such as gains/amplifications/deletions, and to next~     generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation~     detection.~   "
60416|NCT02266407|"~     To assess the surgical and economic effectiveness of the Aquamantys System in managing~     intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing~     both aseptic and septic revision total knee arthroplasty.~   "
60417|NCT02266394|"~     Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at~     recovering kidney function. For this reason we are studying a stem cell product called~     mesenchymal stem cells or MSC. Mesenchymal stem cells (MSC) are grown from a person's own~     fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.~      This study is also being done to determine if the MSC infusion prior to percutaneous~     transluminal renal angioplasty with stenting (PTRA) further enhances changes in single~     kidney blood flow and restoration of kidney function, as well as to assess the relationship~     between MSC dose and measures of kidney function.~   "
60418|NCT02266381|"~     Purpose:~      The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US)~     and US combined with fluoroscopy in the guidance of minimally invasive percutaneous~     nephrolithotomy (MPCNL).~      Methods:~      The investigators will enroll 450 patients who are candidates for MPCNL in our study. By~     simple random sampling technique, patients will be assigned to three 150-patient groups~     (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with~     fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the~     procedure is the same in all three groups.The end point of the study is the comparison of~     outcome of procedure including stone free rate, transfusion rate, operation time, access~     time, length of stay and complications.~   "
60419|NCT02266368|"~     This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent~     with non-coated stents in prevention of UTI in patients with ureteral stents~   "
60420|NCT02266355|"~     Pilot study to evaluate the activity of omalizumab in the prevention of recurrent~     oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study~     will also evaluate the safety of omalizumab (Xolair) when administered in this setting.~   "
60421|NCT02266342|"~     This is a French Registry mandated by the French National Health Authority assessing~     long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of~     the thoracic aorta.~   "
60422|NCT02266329|"~     The purpose of this study is to determine if prazosin is more effective than placebo in~     decreasing frequency, severity, disability, and other negative effects of headaches related~     to mild traumatic brain injury in post-9/11 active duty Service Members and Veterans.~   "
60423|NCT02266316|"~     The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not~     one single disease but an umbrella term used to describe chronic lung diseases that cause~     limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004)~     that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK.~      COPD results from damaged airways in the lungs, causing them to become narrower and making~     it harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of~     air that can be expelled in the first second of breathing out (FEV1) in litres per second.~      COPD is a progressive disease and the condition can have a serious impact on the quality of~     life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and~     increased breathlessness.~      This is a randomised crossover controlled trial of participants with COPD. It compares the~     effectiveness of an air-warming face mask which covers the mouth compared with no face~     covering, in increasing participants exercise capacity and quality of life in cold weather.~     The mask warms air at the mouth by drawing on air warmed beneath the participants clothing,~     through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air~     is expired through the nose.~      24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate~     days. Two tests will be in an environmentally controlled chamber performed at 5°C with~     participants wearing either the mask or no face covering. The third test will be performed~     at ambient temperature outside the chamber.~      The order will be determined by random allocation. Participants will undergo the Treadmill 6~     Minute Walk Test; various measurements will be taken, all of which will be non-invasive.~   "
60424|NCT02266303|"~     The increasing prevalence of diabetes is associated with increased insulin use. In~     developing countries it is frequently necessary to use insulin, with the needle and syringe~     method of administration being the cheapest approach. Competence of health care~     professionals is required to safely initiate insulin. The investigators will evaluate~     whether using a checklist during insulin initiation with a needle and syringe, can improve~     the safety and efficacy of its use.~   "
60461|NCT02265822|"~     Melatonin has been proposed as alternative to midazolam as a premedication in procedures~     preceding anaesthesia induction. The objective of this prospective, randomized, double-blind~     study is to investigate the possible effect of melatonin premedication on the required~     infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin~     on sedation in children undergoing surgery.~      Preoperative anxiety and postoperative analgesia are also assessed in both groups.~   "
60425|NCT02266290|"~     The Objective is to examine the immediate and prolonged effects (seven days) of Kinesio®~     Tape (KT) on balance in subjects with chronic ankle instability using Computerized dynamic~     posturography (CDP). Design. A 7 days follow-up, single-blind randomized controlled trial.~     Setting. University community. Participants. A sample of 30 subjects aged 18 to 28 with CAI~     and subjective perception of ankle instability (FAI) was enrolled in this study.~     Interventions. Participants will be randomly divided into two groups: an experimental group~     in which was applied KT, and a control group in which was applied a placebo tape.Objective.~     To examine the immediate and prolonged effects (seven days) of Kinesio® Tape (KT) on balance~     in subjects with chronic ankle instability using Computerized dynamic posturography (CDP).~     Design. A 7 days follow-up, single-blind randomized controlled trial. Setting. University~     community. Participants. A sample of 30 subjects aged 18 to 28 with CAI and subjective~     perception of ankle instability (FAI) was enrolled in this study. Interventions.~     Participants were randomly divided into two groups: an experimental group in which was~     applied KT, and a control group in which was applied a placebo tape. Main Outcome~     Measure(s). The CDP device employed in this study was Smart Equitest® version 8.2. CDP~     analysis was conducted using the Sensory organization test (SOT). The composite SOT score~     (COMP) and the composite SOT strategy (STR), the partial score for SOT condition 2 (SOT 2)~     and its strategy (STR 2) were considered as outcomes measures.~   "
60426|NCT02266277|"~     The goal of this research study is to improve rates of appropriate influenza and~     pneumococcal vaccination among adults who receive care at a large multi-specialty group~     practice in central Massachusetts.~      The investigators plan to conduct a non-blinded randomized controlled trial during flu~     season 2014-2015 (Cycle 1). A total of 20,000 e-portal users and 10,000 non e-portal users~     who are identified in the Reliant Medical Group (RMG) Electronic Health Record (EHR) as not~     being up to date on their influenza vaccines will be randomized.~      E-portal users will be randomized to receive:~        -  Arm 1: E-portal message with Interactive Voice Recognition (IVR) call~        -  Arm 2: E-portal message with no IVR call~        -  Arm 3: No e-portal message with IVR call OR~        -  Arm 4: No e-portal message with no IVR call (Control, e-portal users)~      Non e-portal users will be randomized to receive either:~        -  Arm 5: IVR call OR~        -  Arm 6: no IVR call (Control, non e-portal users)~   "
60427|NCT02266264|"~     The purpose of this study is to compare hyperglycemia and other effects, include 28-day~     mortality and time to reversal of shock between 100 milligrams and 200 milligrams of~     hydrocortisone as initial dosage in patients with septic shock.~   "
60428|NCT02266251|"~     Disease of the aortic heart valve is both common and progressively disabling, with no~     effective medical treatment. In November 2011, the United States Food and Drug~     Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to~     surgical aortic valve replacement (AVR). This new technology has changed the treatment of~     patients with aortic valve disease. In doing so, it has created a pressing clinical need for~     shared decision making tools that will help patients understand the risks and benefits of~     each treatment alternative in the setting of their individual characteristics.~      The overarching goal of this study is to develop a new way to approach the treatment of~     medical illness, by focusing on the expected treatment outcomes for individual patients~     using information collected from large groups of patients. The corner-stone of this model is~     a public website that is designed to engage patients and clinicians in a personalized~     discussion of treatment alternatives. To achieve this goal for patients with aortic valve~     disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and~     American College of Cardiology (ACC) national procedural registries that has been linked to~     Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical~     versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2)~     create and evaluate personalized decision assistance tools for all patients considering AVR.~     This work will be accomplished in direct partnership with both patients and caregivers as~     well as a diverse group of stakeholders who will help ensure its usefulness and~     dissemination.~   "
60429|NCT02266238|"~     The purpose of this study is to compare the effect of DSA guided percutaneous balloon~     dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the~     treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.~   "
60430|NCT02266225|"~     The goal of this study is to evaluate how to implement an evidence-based~     lifestyle-integrated strength and balance exercise (LiFE) intervention in primary care to~     promote increased physical activity (PA) and improvements in function and quality of life in~     older adults 75 years or older. This study will evaluate the public health impact of the~     LiFE intervention using the RE-AIM model: reach (recruitment), effectiveness (PA levels),~     adoption (physician acceptance), implementation (fidelity), and maintenance (retention,~     adherence). If the intervention appears feasible, we will use the resultant information to~     design a larger pragmatic trial.~   "
60431|NCT02266212|"~     Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among~     current, past and non smokers are determined by comparing and analyzing frequency~     distributions. To determine whether smokers require more post operative opiate analgesics~     than others. Multivariate analysis will be performed to identify the major and the minor~     factors predicting the use of postoperative pain therapy. Our previous related study showed~     that the smoker male patients consumed more analgesics than those without smoking, but the~     female group showed the similar findings. However, the case number, especially the female~     cases, is underpowered. Investigators hope to increase the case number to have a better~     statistical and clinical significance.~   "
60432|NCT02266199|"~     The study includes operative as well as conservative patients using a questionnaire~     containing items of pain quality. After having completed the questionnaire, the patient is~     interviewed by an assistant. By this way the new questionnaire should be validated.~      In addition the patient´s personal experiences are included and conservative patients can be~     compared to operative patients.~   "
60433|NCT02266186|"~     The purpose of this project To study the efficacy of Internet-based guided self-help program~     of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group~     of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a~     control group receiving individual support at their antenatal clinics.~   "
60519|NCT02265055|"~     To observe whether Number of early cleavage embryos can be a predictor for multiple~     pregnancies after ICSI.~   "
60434|NCT02266173|"~     This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing~     surveillance) will evaluate the safety of pertuzumab in approximately 3000 participants with~     metastatic or locally unresectable recurrent breast cancer who have never received~     chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their~     metastatic disease with HER2 positivity in Korea. Participants who are administered with~     pertuzumab according to medical opinions of the doctor in charge of surveillance will be~     registered for this study and treated with pertuzumab under the approval conditions of the~     product in Korea.~   "
60435|NCT02266160|"~     The investigators like to learn whether EMLA cream 5% helps tinnitus patients. so far it is~     known that lidocaine I.V do helps tinnitus but until now it is not clear if topical~     anaesthetics (e.g EMLA cream) helps tinnitus.~      The investigators are going to compare 4 days of treatment of EMLA 5% cream Versus (VS.)~     cetomacrogol cream (water- based lotion cream) in treating tinnitus patients.~   "
60436|NCT02266147|"~     To assess the safety and tolerability of escalating doses of SD-101 in combination with~     localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell~     lymphoma.~   "
60437|NCT02266134|"~     Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion~     annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based~     intervention framework that has been shown to improve outcomes for depressed clients by~     identifying those who are not making progress and reducing the likelihood that clients will~     deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of~     community mental health counselors do not regularly assess target problem symptoms to guide~     their work. This study will test a standardized versus a tailored approach to implementing~     MBC that will include the integration of symptom monitoring capacities into the electronic~     health record system of one of the nation's largest not-for-profit providers of behavioral~     health services.~   "
60438|NCT02266121|"~     Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments~     to enhance their cognitive aptitudes.~   "
60439|NCT02266108|"~     The proposed research aims to pilot a multi-strategy structural intervention combining~     community mobilization to promote gender equity alongside an economic intervention~     (microfinance and business training) in order to reduce gender-based violence and HIV risk~     among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA:~     Economic and Social Empowerment To Increase Upwards Mobility Among Women. The evaluation~     will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will~     be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic~     intervention) or 2) a wait-list control group. For this preliminary work, at 12 months~     follow-up, we hypothesize that compared to control participants, intervention participants~     will have: 1) significantly greater economic security (e.g. decreased debt, increased~     income, decreased number of sex trades) and 2) significantly greater perceived collective~     power (i.e. collective efficacy) to address gendered power imbalances within social~     structures and the community. The long-term goal of this program, upon future refinement and~     large scale implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately,~     alleviate a multitude of health burdens among women. Furthermore, we expect that such work~     will highlight the need for HIV prevention initiatives in Mexico, and elsewhere, to more~     broadly consider women's 'life contexts' - addressing economic and social burdens in women's~     lives, to reduce the burden of poverty, gender, and HIV, as well as the intersection of~     these among women.~   "
60440|NCT02266095|"~     The oval-8 splint has been developed for many uses in finger pathology and trauma. It has~     not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating~     thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment~     option for non-operative management. Many studies have been performed showing that thumb~     spica splinting in abduction with either a hand based or forearm based splint improves pain.~     This study aims to compare the effects of a novel splinting approach with oval-8 splints for~     the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee~     splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of~     patients with thumb CMC joint arthritis.~      This is a pilot study will address the following hypothesis: Splinting of the hyperextended~     thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on~     physical exam compared to splinting with thumb spica splints in patients with thumb CMC~     arthritis.~   "
60441|NCT02266082|"~     Women with early-stage breast cancer (BrCA) are surviving longer, but many experience~     symptoms after curative treatments. Approximately 50% of BrCA survivors experience~     persistent pain post-surgery. Identifying individuals at high risk for long-term symptoms is~     important for restoring function and enhancing quality of life. This pilot study will~     investigate psychological (depression, anxiety, catastrophizing) and biological~     (inflammatory markers, gut microbiome, pain sensitivity) correlates of persistent~     post-surgical pain in women participants with early-stage BrCA. The investigators will also~     investigate the type of surgery that participants had and whether it is related to~     persistent pain. The investigators plan explore these factors over time.~   "
60442|NCT02266069|"~     It is important to provide high quality palliative care to all patients with a non-curable~     and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides~     tools for health care professionals to help them delivering palliative care timely and~     accurately.This study investigates whether the implementation of the CPPPC really helps to~     improve patients' lifes.~   "
60458|NCT02265861|"~     This research is to investigate the response of vascular active factors, vascular~     endothelial growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in~     patients with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved~     60 women undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases~     were stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of~     the menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the~     injection (0 hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF,~     AT-Ⅱ were measured by radioimmunoassay.~   "
60459|NCT02265848|"~     Study designed to compare the conventional stimulation programming versus the high frequency~     stimulation programming of the spinal cord stimulator for subjects who already have a spinal~     cord stimulator.~   "
60460|NCT02265835|"~     Retrospective analysis of data concerning anastomotic airway complications after lung~     transplantation.~   "
60443|NCT02266056|"~     Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk~     of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an~     increased mean arterial pressure and systemic vascular resistance due to sympathetic~     excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in~     order to achieve a pneumoperitoneum, and increased abdominal pressure following a~     pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by~     increasing the left ventricular end systolic wall stress and the right and left ventricular~     filling pressure, while decreasing the stroke volume and cardiac index. The author compared~     the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle~     relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for~     colorectal cancer as part of preliminary research. The results showed that deep muscle~     relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal~     pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by~     an average of 8. Above all, even after lowering the intra-abdominal pressure with deep~     muscle relaxation, the surgeon was able to maintain a view almost identical to the one~     afforded by medium muscle relaxation. However, up until now, no reports have clearly~     indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change,~     post-operative recovery, and surgical prognosis depending on the depth of muscle~     relaxation.Against this background, this study aims to identify the degree to which~     intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle~     relaxation, and the corresponding advantages this method presents in terms of physiological~     changes such as hemodynamic and respiratory system changes. In addition, the study intends~     to examine the difference between deep muscle relaxation and medium muscle relaxation in~     terms of surgical prognosis, including their effects on post-operative pain and on the~     patient's recovery of intestinal mobility.~   "
60444|NCT02266043|"~     In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton~     plate, the main treatment approach currently used in Germany for Pierre-Robin-Like~     phenotype, on upper airway obstruction and failure to thrive using objective criteria~     (mixed-obstructive apnea index assessed by polysomnography, standard deviation score for~     body weight) upon admission and 3 months after hospital discharge.~   "
60445|NCT02266030|"~     This is a prospective interventional study to assess the effect of cilostazol compared with~     aspirin in Korean T2DM patients with atherosclerosis.~   "
60446|NCT02266017|"~     Pain in cancer patients is estimated to be as high as 90% and results in physical and~     psychological disability. Behavioral interventions that increase patients' confidence in~     their ability to manage their pain have been shown to be beneficial. Behavioral~     interventions for cancer pain teach patients how their thoughts and feelings can influence~     their pain and specific strategies (e.g., relaxation) for decreasing cancer pain. However,~     despite guidelines recommending such interventions be used in the care of cancer patients~     with pain, they are not routinely used. A critical barrier to the use of behavioral~     interventions is that patients have difficulties attending appointments which are typically~     offered at the medical center during normal business hours. Mobile health (mHealth)~     technologies provide new opportunities to decrease such barriers. The investigators have~     developed a new mHealth approach that may increase the use of behavioral cancer pain~     interventions and ultimately lead to greater use of interventions that can decrease pain and~     disability.~      The investigators propose to test an approach that uses mHealth technologies to deliver a~     behavioral cancer pain intervention to patients in their home using a tablet computer (e.g.,~     iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160~     cancer patients with breast, lung, prostate, or colorectal cancer pain to receive either~     mHealth Pain Coping Skills Training system (mPCST) or to receive a traditional in-person~     pain coping skills training intervention protocol (PCST-trad) at the medical center. The~     investigators will test whether the mPCST is more accessible to patients than PCST-trad. The~     investigators expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning~     that more patients will complete it in a timely manner; b) create less burden meaning it is~     easier for patients physically, emotionally, and financially to participate; c) increase~     engagement meaning that patients will practice skills more and have more understanding of~     the material; and d) be more overall acceptable to patients. the investigators also expect~     that patients who find this intervention more feasible, less burdensome, more engaging, and~     more acceptable will be more likely to experience decreased pain, physical disability, and~     psychological disability, and increased confidence in their ability to manage their pain.~      The investigators' goal is to use mHealth technologies to facilitate wide-spread use of~     behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain~     interventions will particularly benefit patients living far from medical centers (e.g.,~     rural), experiencing cancer-related physical challenges, and facing other practical barriers~     (e.g., transportation, work) to in-person interventions. These outcomes could lead to future~     work evidencing that mHealth behavioral interventions could be applied to other areas of~     quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with~     persistent pain (e.g., arthritis).~   "
60447|NCT02266004|"~     This study will evaluate the effcts of transcranial direct current stimulation (tDCS) in~     combination with locomotor training in patients with Parkinson's disease (PDD) and freezing~     of gait (FOG).~   "
60448|NCT02265991|"~     Pre- and postoperatively patients who underwent free fibula flap were examined regarding~     donor-site morbidity of the lower extremities.~   "
60449|NCT02265978|"~     This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in~     promoting positive mental health through emotional self-awareness in adolescents.~     Participants will be recruited from second-level schools in Ireland. Schools will be~     randomly assigned to the intervention or control condition. Participants in the intervention~     condition will use CopeSmart for a four week period. Those in the control condition will not~     use any mental health app.~   "
60450|NCT02265965|"~     Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second~     stage arrest of descent to prevent or uterine extension at the hysterectomy site.~   "
60451|NCT02265952|"~     This is an open-label, single-arm study to assess the reduction of low-density lipoprotein~     cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia~     (HoFH).~   "
60452|NCT02265939|"~     Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13~     per contraction region of large bowel up to fifth times during the colonoscopy.~      The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with~     no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be~     assessed by an independent committee using recorded video images.~      The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration.~   "
60453|NCT02265926|"~     The study aims to find out if usage of N95 type respirators affects respiratory parameters~     in pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare~     workers.~   "
60454|NCT02265913|"~     To compare safety and efficacy of Perrigo's antiviral drug product compared to an FDA~     approved antiviral drug product in the treatment of cold sores.~   "
60455|NCT02265900|"~     The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported,~     however the mechanisms are unknown. The purpose of this study is to investigate the~     potential mechanisms of exercise in the brain for the treatment of PD.~   "
60456|NCT02265887|"~     The study will recruit and follow up patients for six months patients newly diagnosed with~     pulmonary hypertension from twelve centers across four countries; South Africa, Mozambique,~     Cameroon, Nigeria. The main aim of the study is to describe the aetiology, natural history~     and management practices of pulmonary hypertension in Africa.~   "
60457|NCT02265874|"~     The purpose of this study is to determine if nicotine treatment is beneficial for the~     treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to~     inflammation. This disease affects your body's organs.~   "
60535|NCT02264847|"~     In women being treated with medicines to help eggs to grow (called ovulation induction), The~     investigators wish to know whether adding medicines (called ovulation triggers) that help to~     release the egg (ovulation) would lead to more women having babies without causing harm~     compared with not giving them ovulation triggers.~   "
60462|NCT02265809|"~     Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused~     by the body's immune destruction of its own insulin producing pancreatic beta cells leading~     to insulin deficiency and development of elevated blood sugars. Currently, medical~     management of T1D focuses on intensive insulin replacement therapy to limit complications~     (retinopathy, nephropathy, neuropathy); nevertheless clinical outcomes remain suboptimal.~     There are intensive efforts to design novel immunotherapies that can arrest the autoimmune~     process and thereby preserve residual insulin production leading to fewer complications and~     better clinical outcomes.~      Genetics are in part the cause of T1D and the majority of genes contributing to T1D produce~     proteins involved in immune regulation (called tolerance). A key player in immune~     tolerance is a molecule called interleukin-2 (IL-2) which enhances the ability of cells~     called T regulatory (Treg) cells to suppress the destruction the insulin producing beta~     cells. Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA~     technology using a genetically engineered E. coli strain expressing an analogue of the human~     IL-2 gene. There is substantial data to suggest that ultra-low doses (ULD) of IL-2~     (aldesleukin) can arrest the autoimmune mediated destruction of pancreatic beta cells by the~     induction of functional Treg cells.~      The former study Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes~     (DILT1D) (NCT 01827735) was a single dose mechanistic study designed to establish the doses~     of IL-2 (aldesleukin) required to induce a minimal Treg increase (0.1 fold from baseline) or~     to induce a slightly larger Treg increase (0.2 fold from baseline) (maximal increase).~     Following on from the DILT1D study, the goal of the DILfrequency study is to use an adaptive~     design to determine the optimal dose and frequency of ULD IL-2 (aldesleukin) to maximize~     Treg function by frequently injecting ultra-low doses of IL-2 (aldesleukin). The~     responsiveness of each T1D participant to a particular frequency of IL-2 (aldesleukin)~     administration informs the frequency of dosing given to the next patient. This strategy~     focuses on improving the function of regulatory T cells that are exquisitely sensitive to~     IL-2 (aldesleukin).~   "
60463|NCT02265796|"~     This is a prospective, double-blind, placebo-controlled, randomized, single-center (North~     Florida- South Georgia VA Medical Center) study. The study objective is to determine if~     ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary~     artery disease patients who have demonstrable myocardial ischemia, but who do not undergo~     revascularization~   "
60464|NCT02265783|"~     The purpose of this study is to validate that the device posts a Sensor-Off message within~     the time frame stated in the proposed claims.~   "
60465|NCT02265770|"~     The overall aim of this project is to improve the outcome of patients diagnosed with~     ependymoma by improving and harmonising the staging and the standard of care of this patient~     population and to improve the investigators understanding of the underlying biology thereby~     informing future treatment.~      The program will evaluate new strategies for diagnosis (centralized reviews of pathology and~     imaging) and new therapeutic strategies in order to develop treatment recommendations.~      Patients will be stratified into different treatment subgroups according to their age, the~     tumour location and the outcome of the initial surgery. Each subgroup will be studied in a~     specific randomised study to evaluate the proposed therapeutic strategies.~      Stratum 1:~      The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen~     with VEC-CDDP following surgical resection and conformal radiotherapy in terms of~     progression free survival in patients who are > 12 months and < 22 years at diagnosis, with~     completely removed intra cranial Ependymoma.~      Stratum 2:~      This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years~     at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving~     to all patients the benefit of VEC chemotherapy whilst randomising half of patients to~     receive additional HD-MTX.~      Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual~     inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to~     the residual tumour will be delivered immediately after the end of the cRT.~      Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of~     postoperative dose intense chemotherapy administered alone or in combination with valproate~     in children <12 months of age or those not eligible to receive radiotherapy .~   "
60466|NCT02265757|"~     This study will compare the effectiveness of different combinations of 5 types of behavioral~     interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g.~     quality of life, cognition, function, mood) matter most to people at risk for dementia and~     their care partners. The results of this study have the potential to direct patients,~     families, and health care providers as to which combinations of behavioral interventions~     provide the greatest potential impact on which dementia prevention outcomes. Greater use of~     behavioral strategies that are targeted to the outcomes of most important to the patient~     will likely improve patient compliance and treatment adherence. This, in turn, can lessen~     the need for medication, health care, and long term care utilization.~   "
60467|NCT02265744|"~     Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic~     lupus erythematosus in male and female adults. Patients who qualify will be randomized to~     either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the~     initial 24 weeks of treatment and who are responding to therapy will have the option to~     continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and~     safety will be assessed over the course of the study through laboratory values, various~     rating scales accepted in systemic lupus erythematosus studies and patient self reporting.~   "
60468|NCT02265731|"~     This study is evaluating the safety and pharmacokinetic profile of venetoclax under a once~     daily dosing schedule in Japanese participants with hematological malignancies.~   "
60469|NCT02265718|"~     The purpose of the study is to evaluate the difference in learning and performance measures~     associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in~     healthy elderly volunteers based on amyloid status.~   "
60470|NCT02265705|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as baricitinib in participants with moderately to severely active rheumatoid arthritis~     who have had an inadequate response to methotrexate therapy.~   "
60471|NCT02265679|"~     Safety, tolerability and pharmacokinetics following single doses~   "
60472|NCT02265666|"~     The objective of the present study is to investigate the relative bioavailability of BIIL~     284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast~     in healthy male volunteers~   "
60473|NCT02265653|"~     The objective of the present study is to investigate the relative bioavailability of two~     BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75~     mg following a standard breakfast in healthy male volunteers~   "
60474|NCT02265640|"~     The objective of the present study is to investigate the relative bioavailability of BIIL~     284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a~     standard breakfast in healthy male volunteers~   "
60475|NCT02265627|"~     To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic~     impairment in comparison to healthy subjects~   "
60476|NCT02265614|"~     This project intends to use preimplantation genetic screening (PGS) with the microarray~     technique to determine the chromosome composition of fertilized eggs, so that only~     chromosomally normal embryos are transferred during IVF. The purpose is to increase the~     probability of pregnancy and childbirth among couples with a history of repeated~     unsuccessful IVF attempts.~   "
60536|NCT02264834|"~     Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the~     concentration of local anesthetic and therefore the motor block.~   "
67839|NCT02169388|"~     Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side~     effects of chemotherapy such as diarrhea,infection,neutropenia etc.~   "
60477|NCT02265601|"~     This study is designed to help the investigators understand more about how people plan for~     their future medical needs, a process known as advance care planning.~      The study is under the direction of Michael J. Green, M.D., and Benjamin Levi, M.D.~     physicians at Penn State Hershey Medical Center.~      Participation in the project takes place during a single visit to the Medical Center campus.~     During this one-to-three hour visit, participants complete several questionnaires and use a~     computer program that produces a printed advance directive that can be shared with their~     physicians and loved ones. Participants will receive compensation toward travel expenses.~   "
60478|NCT02265588|"~     The presented study aims to reduce symptoms of depression and anxiety in adolescents with~     inflammatory bowel disease and increased symptoms of anxiety and depression by using the~     disease specific CBT program (PASCET-PI)in order to improve quality of life and to improve~     the clinical course of disease.~   "
60479|NCT02265575|"~     One of the leading health issues among patients, particularly children, presenting for care~     in low- and middle-income countries is dehydration. When oral rehydration is not sufficient~     or is clinically inappropriate, rehydration often occurs intravenously. An alternative to~     intravenous rehydration is subcutaneous infusion and - with or without hyaluronidase enzyme~     (or Hylenex) - has been shown in several robust trials in high-income countries to be as~     effective and even safer than intravenous infusion. In this study in western Kenya, the~     investigators propose a first-ever randomized controlled trial to evaluate whether~     hyaluronidase-facilitated subcutaneous infusion can be as effective and safe as IV therapy~     among moderate-to-severely dehydrated patients in low- and middle-income countries.~   "
60480|NCT02265562|"~     Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur~     in some cases and sometimes requiring blood transfusion. Recent study proved that~     misoprostol success in reducing blood loss during total abdominal hysterectomy when used~     once before the surgery.~   "
60481|NCT02265549|"~     Published prognostic scores have limitations in prediction of long term survival after~     stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available~     for prediction of local failure. The value of radiomics is evaluated in this perspective.~   "
60482|NCT02265536|"~     The main purpose of this study is to learn more about how the investigational drug,~     LY3022855, affects the immune system in participants with advanced breast or prostate cancer~     that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6~     weeks).~   "
60483|NCT02265523|"~     The purpose of this investigation is to examine the effect of, and improve patient~     compliance and motivation following total knee arthroplasty; to determine the efficacy of~     two post-surgical exercise programs on knee pain, function, range of motion, strength, and~     swelling (girth); and to establish a panel of biomarkers that will allow: a) early~     identification of patients at risk (i.e. unable to complete post-operative treatment) and;~     b) predict the likelihood of a successful treatment outcome post-surgically.~   "
60484|NCT02265510|"~     This is a study of INCB052793 given to patients with advanced malignancies that will be~     conducted in two phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy). Each~     study phase will have two parts; a dose escalation (Part 1) and an expansion (Part 2).~   "
60485|NCT02265497|"~     Currently there are no official data concerning incidence, progression and prognosis of~     patients with lymphoma in Brazil.This project aims the establishment of a network of 12~     Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian~     National Cancer Institute (INCA) as the Coordinating Center.We intend to develop and~     implement a computerized system for data entry and information management of patients with~     lymphomas. This will enable create a virtual registry of demographic, clinical,~     epidemiological, histopathological, molecular, and therapeutic data. This clinical record~     must be linked to histopathological and molecular diagnosis, allowing institutions that work~     in the context of the public health system have access to new technologies for early cancer~     diagnosis.We expect is that this record reliably portrays the scene of lymphomas in our~     state and will become a management model that can be replicated at the national level. Thus,~     the implementation of RELINFO will strengthen the multidisciplinary diagnosis, promote the~     standardization of clinical record of patients with lymphomas and provide subsidies to~     cooperative research projects between participating institutions.~   "
60486|NCT02265484|"~     After successful screening of liver cirrhosis patients attending ILBS OPD for signs of~     parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis~     related parkinsonism will be made. Patients will be randomized into Bromocriptine and~     Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS~     (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will~     be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be~     calculated.~   "
60487|NCT02265471|"~     The objectives of this survey are to determine the level of antimicrobial resistance~     knowledge and perception of health care workers (HCW) in France, to measure the impact of~     health care facilities (HCF) and to identify the drivers and barriers to change. To achieve~     this goal, a cross-sectional survey on one day with a self-administered questionnaire and~     semi-structured interviews with HCWs is proposed. This study will be planned in 60 different~     HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.~   "
60488|NCT02265458|"~     Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV~     failure, and intubation. Music therapy has been used in various clinical context, including~     in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical~     intervention on respiratory comfort during NIV for acute respiratory failure.~   "
60489|NCT02265445|"~     The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to~     another beta-lactam for which the isolated pathogen is susceptible) in patients with~     well-defined ESBL-PE infections (usual sites of infections and non severe infections).~   "
60490|NCT02265432|"~     The purpose of this study is to test an intervention which uses a personalized~     mobile-technology based approach that aims to promote physical activity and reduce sedentary~     behaviour in inactive working Singaporean adults.~   "
60537|NCT02264821|"~     The aim of this study is to compare effective analgesia with continuous wound infiltration~     of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to~     spinal anesthesia, after elective Caesarean delivery.~   "
60491|NCT02265419|"~     Heart-surgery with the use of a heart-lung-machine can trigger the development of a~     full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe~     sepsis in the course of disease.~      For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are~     in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for~     the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific~     cytokines and other inflammation mediators from the patients blood.~      In this study (as a case-observation and compassionate use) the effect of extracorporeal~     treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation~     and SIRS after heart-surgery with use of a heart-lung-machine will be observed.~      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber~     on the course of hyperinflammation and multi organ failure in comparison with a historic~     control group.~   "
60492|NCT02265406|"~     Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections~     in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases~     morbi-mortality, length of stay in intensive care and overall management costs. The~     prevention of ICU nosocomial infections depends on several measures : orotracheal intubation~     route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated~     position >= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid~     unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early~     weaning from ventilation. Two randomized study show that administration of antibiotic~     therapy after intubation reduces the risk of early VAP incidence. However, in clinical~     practice, its administration solely purposes of limiting VAP occurence is not presently~     recommended. Indeed, to date no placebo blind controlled study was been realized and the~     fear of development of bacterial resistance remains stronger than the efficiency of this~     prevention measure. This aim of the present study is to show by a placebo randomized study~     that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk~     of occurence an early VAP.~   "
60493|NCT02265393|"~     This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the~     United Kingdom. The first part is a randomized, placebo-controlled study comparing the~     safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part~     is an open-label extension where all subjects will receive an additional 2 intratympanic~     injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for~     a total of 1 year.~   "
60494|NCT02265380|"~     A prospective, single-center, open-label, randomized controlled trial to demonstrate the~     safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study~     hypothesis is that OptiVein IV Catheter use will be superior to the control in successful~     venous access after first attempt.~   "
60495|NCT02265367|"~     The purpose of this study is to provide preliminary information assessing if levomilnacipran~     may be effective at increasing smoking cessation rates.~   "
60496|NCT02265354|"~     This study will advance computer tailoring by adapting machine learning collective~     intelligence algorithms that have been used outside healthcare by companies like Amazon and~     Google to enhance the personal relevance of the health communication.~   "
60497|NCT02265341|"~     This pilot phase II trial studies how well ponatinib hydrochloride works in treating~     patients with biliary cancer that has spread to other places in the body and that have~     alterations (fusions) in a gene known as fibroblast growth factor receptor 2 (FGFR2).~     Ponatinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
60498|NCT02265328|"~     Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF)~     ≥32, is associated with significant morbidity and mortality. Of the various treatment~     modalities evaluated for treatment of SAH, corticosteroids have been the most extensively~     studied. Five out of 13 RCTs, and four out of 5 meta-analysis have shown a survival benefit~     with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.However, the~     role of corticosteroids in SAH still remains somewhat controversial. Corticosteroid therapy~     is not considered the ideal option by all authors because their beneficial effect seems to~     be confined to a highly selected minority group in which the inhibitory effect of~     corticosteroids on liver inflammation is not outweighed by side effects such as weakened~     defence against infections, anti-anabolic effects, and possible ulcer promoting effects.~     Also corticosteroids are contraindicated in patients with renal failure, gastro-intestinal~     (GI) bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to~     evaluate new therapies for SAH. In a recent trial, combination of glucocorticoids plus~     N-acetylcysteine was found to improve one month survival in patients with SAH, compared with~     glucocorticoids alone. However the 6 month survival was not different in both groups.~      Human Colostrum (HC) and Bovine Colostrum (BC) are rich in protein, immunoglobulin,~     lactoferrin and growth factors. Recent studies suggest that colostrum components,~     Lactroferrin, immunoglobulin and growth factor benefits physically active person and in~     treatment of autoimmune disorders. It is used for the treatment of a wide variety of~     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut~     injury, H pylori infection, immune deficiency related diarrhea as well as infective~     diarrhea.~      The guidelines by American College of Gastroenterology and other authors have suggested that~     a combination of CS and other drugs, which have different mechanisms of action, may be more~     beneficial for reducing mortality in SAH. Hence, we plan to conduct this pilot study to~     investigate the efficacy of a novel combination of corticosteroids, and Bovine colostrum in~     the treatment of SAH.~   "
60499|NCT02265315|"~     The purpose of this study is to evaluate the impact of a non-invasive brain stimulation~     technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people~     with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of~     voice box, and brain imaging methods.~   "
60500|NCT02265302|"~     Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the~     pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by~     determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary~     pharmacokinetic data as well as first information on food effects after administration of~     the 75 mg WIF tablet in healthy male volunteers~   "
60501|NCT02265289|"~     To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg~     Lefradafiban tid~   "
60502|NCT02265276|"~     Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic~     syndrome. The prevalence of the same has been increasing rapidly in India, along with an~     increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying~     pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and~     the therapeutic options are limited. Insulin sensitizing drugs are used in the management of~     NAFLD.~   "
60538|NCT02264808|"~     Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and~     in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits~     and/or death at 18-20 months.~   "
60503|NCT02265263|"~     The research leading consortium to these results has received funding from the European~     Union Seventh Framework Programme [FP7/2007-2013] under grant agreement no 602461~     (www.biocog.eu).~      The investigators will establish valid biomarkers panels (neuroimaging and molecular) for~     risk and clinical outcome prediction of postoperative delirium (POD)/postoperative cognitive~     deficit (POCD) in N = 1200 elective surgical patients (Age ≥ 65 years) in study centers in~     Berlin,Germany (data collection within 5 years after initial hospital stay) and Utrecht, The~     Netherlands (data collection within 1 year after initial hospital stay), thereof~     cerebrospinal fluid (only once on day of surgery in patients with planned spinal~     anesthesia/combined spinal epidural analgesia in N = 200 patients, only in Berlin).~     Post-mortem samples of brain tissue are analyzed in a limited number of voluntary patients,~     only in Berlin.~      A control group of 300 ASA II/III- patients (200 from Berlin and surrounding area and 100~     from Utrecht and surrounding area ) is collected for measuring the learning experience~     during the cognitive testings. The participants are matched on age, education, and gender to~     the study patients. The 300 ASA II/III- patients from Berlin and surrounding area and~     Utrecht and surrounding area receive additionally MRI-scan (3 Tesla) at baseline, after 3~     months and after 1 year.~      An interim-analysis is performed on the primary endpoint after 400 included patients.~      The resulting (multivariate) expert system is expected: 1) to support clinical~     decision-making in patient care, e.g. to balance the individual POD/POCD risk against the~     expected overall clinical outcome of an (elective) surgical intervention, 2) to allow the~     design of more sophisticated and hypothesis-driven clinical studies and drug trials~     (translational research) in the future. The latter will be possible on the basis of~     biomarker-based sub-grouping of patients and a better understanding of relevant~     pathophysiological processes.~      Furthermore, a state-of-the art clinical database and biobank will be created that does not~     yet exist worldwide. Both the expert system and the reference database/biobank will expand~     the leadership of the contributing academic institutions in this particular research area.~     In addition, the newly created biobank will become an integral part of the European~     Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) which allows top~     address specific and hypothesis-driven research questions.~      Most notably, the developed (multivariate) expert system also has the potential for~     commercialization. Possible customers are: 1) physicians and hospital departments being~     involved in pre-surgical decision making, 2) pharmaceutical industry intending to conduct~     biomarker-based drug trials in POD/POCD.~   "
60504|NCT02265250|"~     Cardiovascular disease (CVD) remains the leading cause of death in the United States, and~     improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures~     including plaque volume and adverse plaque features have prognostic value. Novel techniques~     have been developed for assessing carotid, coronary, and femoral atherosclerosis using~     magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved~     spatial resolution, and do not require contrast media, making atherosclerosis assessment in~     multiple vascular beds feasible during a single MRI session. This pilot research will~     provide preliminary data to develop an innovative global atherosclerosis measure including~     carotid, coronary, and femoral vascular beds, for assessing cardiovascular risk and for~     monitoring atherosclerosis response to therapy. 20 participants will be recruited in one~     year.~   "
60505|NCT02265237|"~     The purpose of this study in HCV genotype 4-infected subjects with compensated cirrhosis is~     to assess the safety and to compare the percentage of subjects achieving a 12-week sustained~     virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification~     (LLOQ) 12 weeks following treatment], to a clinically relevant threshold [based on SVR rates~     for HCV genotype 4-infected subjects treated with pegylated interferon (pegIFN)/RBV].~      The 12 and 16-week arms have been fully enrolled. As of 19 May 2015, they were closed and~     the two 24-week arms were opened for enrollment.~   "
60506|NCT02265224|"~     This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence~     study to compare two different oral formulations of NAC.~      The study has been conducted in healthy volunteers of both genders, in one single dose of~     both formulations.~   "
60507|NCT02265211|"~     This study evaluates a self-help app in the treatment of shyness and social anxiety in~     adults. All participants will be assigned to the treatment group. It is expected that using~     this app will result in a reduction in social anxiety.~   "
60508|NCT02265198|"~     Pulmonary contusion (PC) is a significant problem after blunt trauma that may often lead to~     acute respiratory distress syndrome (ARDS) and in some patients, death. Although the~     pathophysiology is incompletely understood, it is clear that there is a biochemical process~     involving changes in the inflammatory milieu after contusion which occurs in addition to~     simple direct mechanical injury to the lung. The relationship of severity of contusion on~     imaging, disturbances in the inflammatory phenotype, and outcome is unknown. This is a~     prospective, observational study which will evaluate the size and severity of contusion as~     measured on chest computed tomography (CT). Inflammatory mediators will be measured in the~     bronchoalveolar lavage (BAL) and in the serum of patients with pulmonary contusion to define~     the inflammatory nature of the post-contusion lung. The degree of abnormality within the~     inflammatory parameters will be correlated with lung contusion size and subsequent patient~     outcomes. These data will be compared to other patient groups: 1) Trauma patients without~     chest injury who are mechanically ventilated; 2) Uninjured patients undergoing elective~     surgical procedures that will require intubation and mechanical ventilation; 3) Patients in~     the Medical ICU who are mechanically ventilated with acute respiratory failure.~      The hypothesis tested within this study is resolution of lung injury is dependent upon the~     presence of Tregs in the alveolar space.~   "
60509|NCT02265185|"~     Childhood obesity is a major area of concern for health care and public health. Overweight~     children are more likely overweight and obese adults. Chronic health problems associated~     with adult obesity are now occurring more frequently in children. Because of the associated~     health problems and potential for long term struggles with obesity, intervention early in~     life is essential for addressing the obesity epidemic. Some intervention work in this area~     has focused on the pediatric primary care setting in order to utilize the influence and~     credibility of medical providers. Unfortunately, primary care visits are often too short to~     spend a significant amount of time on issues of diet, weight and nutrition.~      There has been very little work exploring the potential of alternative care settings, such~     as the pediatric Emergency Department (ED) in addressing childhood obesity. While provider~     time is also limited in the ED, there is often a considerable amount of downtime during~     emergency department visits that could be valuable time for patient and parent education.~     There may also be an opportunity to reach parents and children in the ED who do not~     regularly utilize primary care. In order to explore the possibility of pediatric obesity~     interventions in Children's Pediatric Emergency Department, we will need to measure the~     prevalence of obesity in the population that utilizes the Children's ED. The height of~     patients seen in the ED is not routinely measured, which makes calculating BMI to determine~     obesity impossible. This study, establishing the prevalence of obesity in Children's~     Emergency Department will lay the groundwork for future work addressing obesity in the ED.~   "
85851|NCT01933646|"~     Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to~     90 days of age) in China, in terms of incidence, case fatality rate and serotype~     distribution~   "
60510|NCT02265172|"~     Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic~     surgeon, however, a relatively low percentage of these patients are considered suitable for~     orthopaedic intervention.~      Physiotherapists are suitable for musculoskeletal assessments and are used as such in many~     countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists,~     however, this is not an existing model of care in Sweden. To be able to consider this model~     for implementation in Sweden it is necessary to evaluate it from a healthcare as well as~     from a patient perspective.~      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic~     manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic~     surgeon bring any changes to referral routines, patient satisfaction and health-related~     variables when compared to standard practice.~   "
60511|NCT02265159|"~     The investigators aim to evaluate cancer control, genitourinary, rectal and overall~     health-related quality of life outcomes and effectiveness of focal therapy for localised~     prostate cancer using High Intensity Focused Ultrasound (HIFU).~   "
60512|NCT02265146|"~     This is a multi-center, investigator initiated study that will prospectively examine~     treatment strategies and outcomes of patients who underwent clinically-indicated Near~     Infrared Spectroscopy (NIRS). The information collected will be used to determine the~     frequency of NIRS imaging performed at the participating sites and to examine the clinical~     outcomes of the NIRS-detected Lipid Core Plaques (LCPs).~   "
60513|NCT02265133|"~     This study is a prospective, single center clinical trial to assess corneal sensitivity and~     nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy~     volunteers with no history of ocular or uncontrollable systemic disease will be encouraged~     to participate in the study. After execution and review of the consenting procedures, a~     detailed history will be taken and a slit lamp examination performed, verifying ocular~     health. This consists of an examination of both eyes including assessments of ocular lids,~     lashes, cornea and conjunctival evaluation. Corneal touch thresholds will be tested with a~     Cochet-Bonnet aesthesiometer, a standard non-invasive measure of corneal sensitivity.~     Corneal nerves will be imaged using a modified HRT in vivo confocal microscope. The in vivo~     confocal microscope allows for high resolution imaging of the nerve plexus under the corneal~     epithelium. This corneal nerve plexus is responsible for corneal sensitively and changes or~     loss have been established as an early, sensitive indicator of corneal neuropathy. The~     investigators anticipate that this study will require approximately 30 patients for each~     group and will last approximately 12 months for recruitment and completion of subject visit~     phases. There is only one clinical visit designed for this project, unscheduled visits may~     be scheduled in case of an adverse event.~      Patient recruitment will be complete at the one-year time point. At the 14 month time point,~     all data points will have been collected and assessment of the outcome measure (corneal~     sensitivity in sleep apnea patients versus control patients) will be complete.~   "
60514|NCT02265120|"~     Significant developments have led to a dramatic change in recommendations for cervical~     cancer screening. The understanding that the Human Papilloma Virus (HPV) is the cause of~     nearly 100% of cervical cancer cases and the development of new technologies for detection~     of HPV DNA at time of cervical cancer screening, has produced changes in preventive~     healthcare policy for this condition. In an unprecedented event, the American College of~     Obstetrics and Gynecology, the American Cancer Society and the U.S. Preventive Services Task~     Force recommended dramatic and unified changes in screening utilizing this new framework. No~     studies of significance have evaluated (since guideline change in 2013), whether primary~     care providers find the new recommendations authoritative and believe in them, or whether~     providers understand implementation of these new guidelines given the many decades of~     contradictory and differing recommendations. For this study, the opinions of primary care~     providers who care for patients in the 194 federally designated regions of Primary Care~     provider shortage within California will be studied. Using the California Medical Board~     database of licensed providers, a questionnaire will be mailed to a random subset. It is~     anticipated that the analysis will show varying contempt, confusion and compliance with new~     guidelines exists. Understanding these factors will have beneficial health policy~     implications in terms of overcoming barriers to these cost-effective, less intrusive, and~     more accurate health policy guidelines in the prevention and early detection of cervical~     cancer.~   "
60515|NCT02265107|"~     Objective: To observe the effects of exercise training on vascular endothelial function in~     patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months~     of Cardiac rehabilitation programs (CRP).~      Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year~     to participate in a CRP with duration of six months with three weekly sessions of 1 and half~     hour of the duration. All patients underwent biochemical blood tests, muscle strength~     testing of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test~     (6MWT), and evaluation of endothelial function (using flow-mediated vasodilation).~   "
60516|NCT02265094|"~     The aim of this study is to investigate the neural substrates of associative memory in~     Autism Spectrum Disorder using both behavioural and EEG assessments.~   "
60517|NCT02265081|"~     The proposed study is to evaluate if there are specific factors in the pelvic floor~     functional anatomy which can predict the ability of having a vaginal birth after caesarean~     section.~      Physical characteristics of the soft tissue in the female pelvis play an important role in~     successful vaginal delivery. A tight or less distensible pelvic floor muscles may~     influence mode of delivery, leading to poor labour progression and by compressing foetal~     head produce CTG abnormality such as decelerations, both resulting in caesarean delivery.~      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the~     passage of fetal head through the birth canal by stretching and distending. Therefore~     distensibility of the female pelvic floor influences mode of delivery.~      Three hundred patients, in the third trimester of pregnancy, will be recruited via the~     antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible~     participants are pregnant women who had either one or no vaginal births, or one caesarean~     section and who can give an informed consent and maintain their autonomy regarding mode of~     delivery with understanding of the forthcoming study results. Participants will be excluded~     if they sustain any obstetric complications that may impede on time and mode of delivery~     including an emergency prelabour caesarean section.~      Ultrasonographic assessment of the differences in the pelvic characteristics of these women~     will be used to predict a successful of trial of vaginal delivery after caesarean section~     (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is~     a simple (single ultrasound assessment) that can be used to help inform women's choice~     regarding mode of delivery.~      Results from this research could be a pioneering blueprint for further studies, as there is~     very little known about this topic.~   "
60518|NCT02265068|"~     Documentation of long-term data regarding ticagrelor use and evaluation of reasons for~     discontinuation of ticagrelor in patients with ACS~   "
60520|NCT02265042|"~     The aim of the study is to investigate whether there is an effect of electrical stimulation~     on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury.~     The expected outcome is an increase in muscle volume and a better pressure distribution~     during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over~     a period of six months. The muscle volume and the pressure distribution are measured before~     stimulation, three months after having started stimulation and after six months.~   "
60521|NCT02265029|"~     Fibromyalgia is a common health problem that causes widespread pain and tenderness~     (sensitive to touch). The pain and tenderness tend to come and go, and move about the body.~     There is no cure for fibromyalgia. Complementary and alternative therapy such as~     acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia~     symptoms. Many of these treatments have not been well tested in patients with fibromyalgia.~     Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with~     rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most~     often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with~     a major alteration of quality of life.~      Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects~     of spa therapy in rheumatologia on evolution of disability in daily life of patients with~     fibromyalgia.~   "
60522|NCT02265016|"~     The aim of this study is measurement of expression and activity of RBC eNOS in different~     clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to~     investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.~   "
60523|NCT02265003|"~     The aim of this study is to find out, how far red blood cells reflect age-depended changes~     in endothelial function.~   "
60524|NCT02264990|"~     This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus~     carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in~     current or former smokers who are receiving their first cytotoxic therapy for metastatic or~     advanced non-squamous non-small cell lung cancer.~   "
60525|NCT02264977|"~     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic~     Branch Endoprosthesis to treat aneurysms involving the aortic arch~   "
60526|NCT02264964|"~     The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be~     investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal~     failure requiring hemodialysis will be enrolled. 900 patients will be given right internal~     jugular catheterization, and the other 500 patients unsuitable for right internal jugular~     catheterization will receive femoral catheterizations. Every patient will be followed-up for~     six months. During following-up period, the duration time and adverse events of non-cuffed~     catheter will be recorded in details, including inadequate hemodialysis blood flow, venous~     stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will~     be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This~     multicentre trial will provide evidence to develop guideline for duration time of using~     non-cuffed catheter.~   "
60527|NCT02264951|"~     This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of~     20 ml olive oil on a molar basis in human volunteers.~   "
60528|NCT02264938|"~     Purpose: To determine drusen morphology (volume and area) changes in nonexudative~     age-related macular degeneration (AMD) after one year of oral supplementation with~     AREDS-like formulation.~   "
60529|NCT02264925|"~     The objective of this study is to characterize through spectral analysis intra-thalamic~     local field potentials (LFPs) recorded through implanted DBS leads during periods with and~     without tremor in patients suffering from severe essential tremor.~   "
60530|NCT02264912|"~     The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry~     was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who~     underwent intracoronary stent implantation, have been included regardless of whether~     percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients~     were included in the registry after having signed an informed consent for participation. No~     exclusion criterion has been applied for the registry participation. Efficacy of P2Y12~     receptor antagonists has been measured by quantitative flow cytometric analysis of~     vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer~     protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow~     cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days,~     6-months and one year follow up has been investigated.~   "
60531|NCT02264899|"~     A Multicenter national longitudinal cohort study including at least 800 individuals~     recruited from French Research Memory Centers and followed up over 36 months and included in~     Memento.~   "
60532|NCT02264886|"~     The purpose of this research study is evaluate whether it's feasible to give radiation~     therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy~     involves the adjustment or re-planning of treatment day by day while the participant is~     receiving treatment. The adaptive technique has previously been used in a different fashion~     to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment~     while the participant is still on the table is a new way of using the adaptive technique.~     This may allow doctors to use more radiation to treat the tumor while better protecting~     normal tissues. A special radiation treatment machine incorporates both an MRI scanner and~     radiation treatment devices so that the planning and treatment can be done using the same~     machine.~   "
60533|NCT02264873|"~     Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in~     Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on~     the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant~     (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune~     system and lead to a longer disease free survival. The study is designed to provide safety~     data of low-dosing in the post-transplant setting.~   "
60534|NCT02264860|"~     HIV infection causes systemic zinc deficiency and oxidative stress that impairs host~     immunity in the alveolar space.The purpose of this study is to see if taking two nutritional~     supplements, zinc and SAMe (S-adenosylmethionine), can improve lung health and immune~     function in persons with HIV.~      The investigators hypothesize that long-term dietary supplementation with zinc and the~     glutathione precursor SAMe will enhance pulmonary host immune function in HIV-infected~     individuals who do not respond adequately to ART alone.~   "
60539|NCT02264795|"~     The instillation of local anesthetic into the peritoneum has been found to be safe and~     effective in reducing postoperative pain and morphine consumption after abdominal surgery. A~     review of studies reporting serum levels of local anesthetic after intraperitoneal delivery~     found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis~     did not include post-cesarean delivery pain and there is a lack of data to support the use~     of intraperitoneal local anesthetic after cesarean section.~      The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on~     postoperative pain scores after cesarean delivery. This study will compare a 20ml solution~     of lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into~     the peritoneum at the end of surgery in women undergoing cesarean delivery. The~     investigators hypothesize that intraperitoneal lidocaine will result in lower pain scores,~     reduce opioid consumption and opioid related side effects, and higher maternal satisfaction~     after cesarean delivery.~   "
60540|NCT02264782|"~     PreView is a novel tool that functions within the system in a busy clinic setting,~     integrates information obtained from a particular patient with provider alerts, is~     efficient, relieves the burden of time constraints and is tailored to the individual~     patient. The goal of PreView is to support and simplify the physician's role in promoting~     cancer screening.~   "
60541|NCT02264769|"~     PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most commonly used uterotonic drug to prevent and treat PPH in North America. However~     oxytocin has a very short duration of action, requiring a continuous infusion to achieve~     sustained uterotonic activity. Moreover large doses are associated with adverse effects like~     hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and~     Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at~     elective cesarean delivery to promote uterine contraction. In three studies recently~     performed at Mount Sinai Hospital, the investigators have found no difference in uterine~     contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg.~     Thus a larger trial comparing the minimum effective dose determined in the previous three~     trials with the standard 100 mcg dose is necessary to confirm these findings.~   "
60542|NCT02264756|"~     The purpose of the study is to determine whether an antimicrobial stewardship program can~     decrease the length of hospital stay for patients with pneumonia. The antimicrobial~     stewardship program is run by a pharmacist and doctor with extensive training in managing~     infectious diseases. These two health care professionals are responsible for reviewing the~     records of patients admitted to hospital with pneumonia, and then making specific~     recommendations to the patient's attending physician about how to manage antibiotic~     treatment. These recommendations might include discontinuing the antibiotic, or changing the~     way antibiotics are delivered from intravenous form to pill form, among many other potential~     options. The attending physician considers whether these recommendations should be followed~     or rejected. The study has a control group of patients who are not reviewed by the~     antimicrobial stewardship team, and their length of hospital stay will be compared to the~     reviewed group of patients. Any differences between these two groups will be assumed to be~     due to the impact of the antimicrobial stewardship program. So far, no previous study has~     been able to demonstrate that an antimicrobial stewardship program can reduce the length of~     stay of patients admitted to hospital with pneumonia. This study has some important~     differences from previous studies that may make its conclusions more accurately reflect the~     true impact of antimicrobial stewardship programs. The most important difference is how the~     timing of the review is modelled in the analysis of the study results. Because the timing of~     the review varies between patients, with some patients being reviewed at earlier and some at~     later times, this subtle difference, if not accounted for in the analysis, can mask a true~     positive effect of the program on length of stay. The investigators study will account for~     this variation.~   "
60543|NCT02264743|"~     Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids~     and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will~     be avoided.~   "
60544|NCT02264730|"~     Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal~     Surgery in Which Liver Bleeding is Encountered.~   "
60545|NCT02264717|"~     1. The primary purpose of this study is to determine the diagnostic accuracy of the CADscore~     System, a new danish technology that records sounds from turbulence of bloodflow in the~     coronary vessels.~      And secondary:~        1. To determine the accuracy of cardiac magnetic resonance imaging (MRI) and single-photon~          emission computed tomography (SPECT), as secondary tests after detection of obstructive~          anatomic coronary artery stenosis by coronary computed tomographic angiography (CCTA).~        2. To examine the patient population for bio-genetic markers related to development of~          arteriosclerosis.~        3. To evaluate virtual fractional flow reserve (vFFR) computed from coronary angiograms.~   "
60546|NCT02264704|"~     This study aims to determine the effect of exercise intensity within a 15 week programme in~     moderately disabled people with multiple sclerosis (MS). Although earlier research has shown~     that exercise is safe and may improve health related factors such as mobility and fatigue,~     the intensity at which exercise offers the most benefit has not yet been defined.~      Participants will be randomly assigned to one of three groups - high intensity, moderate~     intensity or usual care. Participants in the exercising groups (high and moderate intensity)~     will take part in a supervised 15 week cycling exercise programme based in the Douglas Grant~     Rehabilitation Centre. Those assigned to the usual care (control) group will continue to~     receive their usual medical care and will not participate in the exercise programme. The~     acute immune response to exercise will also be measured.~      Participants from all three groups will be monitored regularly. Clinical outcomes of the~     study include immunological markers, exercise capacity, mobility, fatigue, quality of life~     and cognitive ability. These will be measured by a combination of blood tests, physical~     assessments and questionnaires.~      It is hypothesised that high intensity exercise will cause a favourable, anti-inflammatory~     response which will be associated with greater improvements in physical and psychological~     outcomes than both moderate intensity exercise and usual care.~   "
60547|NCT02264691|"~     To identify and understand biologic aspects of severe asthma compared to subjects with mild~     to moderate asthma and subjects without asthma (normal or healthy volunteers).~   "
60548|NCT02264678|"~     This is a modular, phase I/ phase 1 b, open-label, multicentre study of AZD6738 administered~     orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents,~     to patients with advanced malignancies. The study design allows an investigation of optimal~     combination dose of AZD6738 with other anti-cancer treatments, with intensive safety~     monitoring to ensure the safety of the patients. The initial combination to be investigated~     is AZD6738 with carboplatin. The second combination to be investigated is AZD6738 with~     Olaparib. The third combination to be investigated is AZD6738 with MEDI4736.~   "
60549|NCT02264665|"~     A descriptive, prospective (partly retrospective), multisite, observational study conducted~     in France in adult patients treated for a well differentiated, unresectable or metastatic,~     pancreatic neuroendocrine tumor with disease progression.~   "
60550|NCT02264652|"~     High-Definition transcranial Direct Current Stimulation (HD tDCS)~      Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be~     arranged on the skull according to a 4x1-ring configuration with the central cathodal~     electrode placed over the identified target and surrounding return electrodes forming~     approximately a 5-cm radius ring.~      Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could~     potentially suppress seizures in refractory partial-onset epilepsy.~   "
60551|NCT02264639|"~     This study will be the initial exploration of APL-2 in patients with PNH. The assessments of~     the safety, tolerability, PK, and PD following administration of single and multiples doses~     of APL-2 will guide decisions to further develop the drug.~   "
60552|NCT02264626|"~     In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main~     reason of failure.~      This may result in a poor synchrony between the patient and the machine, leading to gross~     mismatching and potentially to an increased work of breathing.~      The investigators aim to investigate whether in these patients poorly responding to NIV the~     use of a sedation protocol using remifentanil will lead to an improve patient-ventilator~     interaction and better compliance to NIV.~   "
60553|NCT02264613|"~     This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid~     tumors or lymphomas with WT TP53.~   "
60554|NCT02264600|"~     The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease~     (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been~     reported in recent studies. Increased oxidative stress is thought to play an important role~     in cardiovascular complications of WED patients. Apelin is a novel described antioxidant~     bioactive peptide. The investigators hypothesize that patients with WED have lower plasma~     apelin level than healthy subjects based on presence of oxidative stress of WED.~   "
60555|NCT02264587|"~     The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on~     diabetic gastroparesi.~   "
60556|NCT02264574|"~     An open-label, multi-center randomized, phase 3 study of ibrutinib combined with~     obinutuzumab versus Chlorambucil in combination with obinutuzumab in subjects with~     treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.~   "
60557|NCT02264561|"~     The purpose of this study is to determine whether caffeine improves attention.~   "
60558|NCT02264548|"~     -  evaluate the safety and toxicity profile of renal radio-ablation in the setting of~          metastatic renal cell carcinoma.~        -  to assess renal function post radio-ablation~        -  Primary and metastatic tumour response to radio-ablation~   "
60559|NCT02264535|"~     This pilot study is designed to explore the optimal concentration and method of Ginkgolides~     Meglumine Injection skin testing and to evaluate the value of skin test in predicting any~     possible allergic reactions to Ginkgolides Meglumine Injection.~   "
60560|NCT02264522|"~     The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to~     guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients,~     and to further the investigators understanding of homeostasis in hemodialysis.~      The investigators hypothesize that the signals generated from the PPG device along with~     traditional monitoring and nursing judgment, will allow experienced, oriented staff to~     anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic~     hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that~     preclude the patient from achieving an appropriate post-dialysis weight consistent with~     euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to~     wean patients from anti-hypertensive medications and craft patient specific dialysis orders~     and UF profiles that achieve consistent, comfortable treatment to appropriate end points.~      The study aims include:~      Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine~     hemodialysis.~      Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac~     event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to~     reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.~      Aim 4: To develop care paths approved by the medical staff and primary care nephrologist~     allowing RNs to respond to signals from the PPG.~   "
60561|NCT02264509|"~     The purpose of this study is to determine the risk factors associated with the occurrence of~     arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this~     disease. The estimated prevalence is 10%, similar to that reported in the general~     population.~   "
60562|NCT02264496|"~     Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the~     mainstay of curative therapy. With the screening program enabling early detection, surgery~     plays an important role in treatment strategies. Surgery imparts a significant physiological~     and psychological stress on cancer patients.Recent research has demonstrated that a~     fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake~     can improve outcomes by reducing the physiological stress response to surgery. The primary~     objective of this study is to determine whether a defined exercise programme can improve~     recovery and reduce complications after surgery.~   "
60563|NCT02264483|"~     * Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary~     Disease) exacerbations which could be demonstrated by performing low-dose chest CT.~     Differences in the inflammatory profile in sputum and blood in patients with and without~     pneumonia can be seen.~      * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations,~     using chest low-dose CT and to compare clinical and inflammatory differences in blood and~     sputum between patients with and without pneumonia.~      *Material and Methods: Prospective observational study including 75 patients with the~     diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract~     infection. At the time of inclusion clinical features, blood and sputum analysis, chest~     X-ray and chest low-dose CT are performed. The investigators divide the patients into two~     groups according to the existence of pneumonia and the inflammatory pattern in blood~     (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared~     between the two branches.~   "
60607|NCT02263911|"~     The purpose of this study is to understand the relationship of 3 different dosage forms of~     baricitinib. This study will also explore the effect of food on how the body absorbs~     baricitinib. This study will last about 5 weeks, not including screening. Screening is~     required within 28 days prior to the date of first dosing.~   "
60564|NCT02264470|"~     Falls after stroke are common. Previous research has shown that almost every other, 48%, of~     patients with a first-ever stroke fell at least once during the first year after stroke (1).~     Moreover, most of the patients fell during the first three months after stroke onset.~     However, the exact time-point for the falls was not analyzed (1). In addition, many patients~     are falling already during hospital stay (2-5). Reducing the number of falls during~     inpatient rehabilitation on a stroke unit is a high-priority mission. Greater knowledge~     concerning the factors that best predict falls is eligible.~      The aim of the study is to analyze the significance of different physiological,~     psychological and medical factors for predicting the risk of falling in patients with stroke~     per day of care at a stroke unit.~   "
60565|NCT02264457|"~     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses~     are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your~     eyes have astigmatism, which is a normal and common characteristic of the eye. If left~     uncorrected the astigmatism would mean that you would need to wear spectacles for viewing~     distance objects. New IOL designs called toric IOLs help to correct the astigmatism to~     improve your vision after cataract surgery. This study has been designed to look at how well~     a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing~     distance objects. There are many designs of these toric IOLs and for this study we are~     looking to compare two different designs of toric IOLs by putting one lens in your right eye~     and a different type of lens in your left eye. Both lenses are commercially available and~     are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better~     judge the visual performance of these lenses and the ability of these lenses to correct~     astigmatism. In addition the study will involve imaging and examining the IOLs to determine~     the prevalence of any post-operative complications.~   "
60566|NCT02264444|"~     Essential to laparoscopic operations is adequate visualization. Unfortunately there is no~     grading system to assess the degree or quality of visualization. The primary objective of~     the project is to develop a laparoscopic visualization scoring system. We also intend to~     investigate the effects of neuromuscular blockade agents on visualization.~   "
60567|NCT02264431|"~     The main objective of the study is to identify the determinant of sleep characteristics of~     obese patients attempting a tertiary clinical center for obesity management, including~     bariatric surgery.~      More accurately the questions addressed are:~        -  What are the determinants of the sleep habits (sleep duration, chronotype) and of their~          evolution~        -  What are the determinants of sleep breathing disorders (sleep apnea, obesity~          hypoventilation syndrome) and of their evolution~   "
60568|NCT02264418|"~     The purpose of this first-in-human study is to evaluate the safety and tolerability of~     escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the~     maximum tolerated dose and dose limiting toxicities.~   "
60569|NCT02264405|"~     To assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT)~     for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by~     different study protocols used across Europe in various EBMT centres through the careful~     recording and analysis of routinely collected clinical and biological data.~   "
60570|NCT02264392|"~     Standard treatment for a soft tissue abscess involves incision over the area of maximum~     fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound~     to guide this drainage has the potential to improve treatment outcomes by ensuring complete~     drainage of the cavity.~      Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft~     tissue abscesses will decrease treatment failure rate compared to standard blind incision~     and drainage.~      This hypothesis will be tested utilizing a blinded, randomized trial comparing standard~     incision and drainage to ultrasound guided incision and drainage.~   "
60571|NCT02264379|"~     The purpose of this study is to evaluate the outcomes of patients treated with an high dose~     radiation regimen using either stereotactic hypofractionated or normofractionated~     radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a~     desired result or effect) and safety in this setting.~   "
60572|NCT02264366|"~     The ACCELERATION (ACtivity, smoking Cessation, healthy Eating and aLcohol Education,~     inteRvention, and motivATION) Program is a collaborative project in cancer and chronic~     disease prevention that has been designed by and will be delivered amongst cardiopulmonary~     rehabilitation and prevention programs and cancer centres in Ontario (ON), British Columbia~     (BC), Quebec (QC) and Nova Scotia (NS). This project is being funded by the Canadian~     Partnership Against Cancer, Health Canada and Heart and Stroke Foundation of Canada and in~     the amount of $2.4M over a 3 year period (October 2013 - September 2016). The ACCELERATION~     Program is a 12 week structured model of behavioural interventions and education around~     self-management and prevention that aims to access readily available and referable people~     for primary prevention intervention.This program aligns with current provincial, national~     and international chronic disease prevention and management strategies. The goal of the~     ACCELERATION program is to measurably and effectively change the risk factors and health~     behaviours known to impact cancer and other chronic diseases. Specifically we will aim to~     increase physical activity, reduce smoking, encourage healthy eating, and moderate alcohol~     consumption in about 3,000 participants across Canada over 3 years.~   "
60573|NCT02264353|"~     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low~     arousal threshold may wake up too early during a respiratory event, before upper airway~     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the~     respiratory arousal threshold could potentially improve the quality of sleep and sleep~     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit~     some patients with OSA. The overall goal of this project is to determine the importance of~     the arousal threshold in OSA, determine which patients might benefit from a raised arousal~     threshold, and test this hypothesis by using pharmacological manipulation of the arousal~     threshold to achieve this goal.~   "
60608|NCT02263898|"~     This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and~     MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to~     other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may~     stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving~     LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time~     when tumors become resistant to the drugs.~   "
60574|NCT02264340|"~     Tension headache is a common disabling disease and a worldwide public health problem. This~     research tries to demonstrate the efficacy of physical therapy, based on cervical training~     and postural self-correction instructions, which aims to increase the positive results~     obtained from traditional relaxation techniques (Schultz Autogenic Training). University~     students are selected, because headaches are very common in this sector of the population.~     The design is a non-pharmacological randomized controlled trial, with blinded evaluation of~     the response variables. The investigators compare two independent samples. One of them~     receives an only treatment (Autogenic Training) and the other group receives a combined~     program (Autogenic Training + specific cervical exercises and postural correction). Pain~     parameters (frequency, intensity and duration) and drug consumption are measured before~     treatment, and then, at 4 weeks and 3 months, to value the results.~   "
60575|NCT02264327|"~     Clinical social workers, doctors, outreach workers, and all other staff providing direct~     care to vulnerable populations face multiple challenges in obtaining and maintaining~     training and implementing evidence based practices in diverse community settings.~     Motivational Interviewing is a well-established evidence based practice that is challenging~     to implement across programs and agencies because it requires that skills gained from~     training be reinforced as a service provider employs the practice.~      This study builds on findings from a Phase I study. With funding from a Phase I Small~     Business Innovation Research grant from the National Institute of Health, the Center for~     Social Innovation developed the Motivational Interviewing Simulator: An Experiential Online~     Training Tool. The interactive, case-based, multiplayer web-based game allows service~     providers to deepen their skills in Motivational Interviewing (MI), a widely recognized~     evidence-based practice that supports people to make positive behavior changes related to~     health, wellness, mental illness, and addiction.~      The Phase II randomized controlled trial's primary aim is to assess the relative~     effectiveness of three interventions (MI Training Only; MI Training + eBook; MI Training +~     SIM) in increasing provider MI knowledge and skill retention over time.~      During Phase II of this study, we will recruit 180 providers from 18 community agencies~     serving individuals who live in supportive housing, many of whom have histories of mental~     illness, addiction, homelessness, and medical problems. After receiving a standardized~     two-day onsite MI training, participants will be randomized into one of three conditions: 1)~     MI Training Only; 2) MI Training + eBook (an online comparison with comparable information~     to the Simulator without the interactive elements); or 3) MI Training + Simulator. The~     longitudinal, mixed methods study will assess providers' acquisition and retention of MI~     knowledge and skills through surveys and coding of standardized client interviews; barriers~     and facilitators of MI implementation via focus groups; organizational-level data via key~     informant interviews and site visits; and client outcomes for 3,600 clients through surveys,~     administrative, data and focus groups.~   "
60576|NCT02264314|"~     Hearing loss is the third most common chronic condition in over 65 years people, it is~     estimated that 77.8% of older adults suffer from it. However, there are reports of adherence~     to the use of hearing aids of only to 40%. The objective of this project is to measure the~     effectiveness of a tele-educative intervention to improve adherence to the use of hearing~     aids. A randomized controlled trial was performed. The active branch consists of the~     implementation of an educational program called Active Communication Education, consisting~     of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone~     headset use by personnel trained for three months. The control arm will consist of the usual~     care received by these patients. All participants will be assessed at home at 3, 6, 9, and~     12 months after randomization.~   "
60577|NCT02264301|"~     The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin~     injection on withdrawal rate of corticosteroids in patients with active rheumatoid~     arthritis.~   "
60578|NCT02264288|"~     The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo~     controlled, dose range finding study. The study will enroll approximately 133 subjects in~     four treatment groups. The primary objective of the study is to assess the efficacy and~     safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without~     PAD. The secondary objective is to explore potential clinical efficacy by assessing changes~     in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI),~     Transcutaneous oxygen measurements (TcPO2).~   "
60579|NCT02264275|"~     The purpose of this study is to determine if aerobic exercise training can serve as~     comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating~     depressive symptoms and augmenting sleep while bolstering health related quality of life in~     youth with Crohn's Disease and Ulcerative Colitis.~   "
60580|NCT02264262|"~     Activation of the sympathetic nervous system is associated with increased risk of~     ventricular arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive,~     reliable tools to measure sympathetic outflow in human subjects is therefore highly~     desirable.~      Microneurography is the current gold standard measurement technique, whereby multiunit~     postganglionic sympathetic nerve activity is recorded with tungsten ultrafine~     microelectrodes inserted selectively into nerve fascicles of the peroneal nerve. Though this~     technique is considered extremely safe, and has been used successfully for decades in human~     translational physiology experiments, it has not been adopted for routine clinical~     assessment due to the requirement for sophisticated equipment and specific technical~     training and skills. Alternatively, many have adopted heart rate variability as a simple,~     noninvasive technique for assessing sympathetic nerve activity. However, heart rate~     variability does not directly measure sympathetic nerve activity, and there is much debate~     in the literature as to the exact source of sympathetic nerve traffic. For example, many~     believe it is an accurate reflection of cardiac sympathetic nerve activity, but does not~     accurately reflect changes in muscle or skin sympathetic nerve activity.~      To address these limitations, the investigators have developed a simple, noninvasive~     technique to measure sympathetic nerve activity using surface electrodes.~      Despite its great promise, this new approach has not yet been directly validated. The~     purpose of this study is therefore to validate this new technique (refered to as EKG-NA)~     against the current gold standard measurement technique, microneurography.~   "
60581|NCT02264249|"~     The purpose of this study is to determine residual gastric volume and residual gastric pH in~     patients undergoing combined EGD and colonoscopy comparing the standard single dose prep~     with the split dose bowel preparation and same day bowel preparations.~   "
60582|NCT02264236|"~     The purpose of this study is to evaluate the clinical efficacy of an investigational agent,~     P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV~     Non-Small Cell Lung Cancer who have completed their primary chemotherapy without~     progressing, and who still have measurable residual disease.~      A randomized double-blind placebo-controlled trial is designed with the goal being to~     evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor~     response, and secondarily on progression-free survival. Information on safety and~     tolerability will be collected. Humoral and cellular immune responses will be analyzed.~   "
60583|NCT02264223|"~     Previous literature has shown that the molecular form of isoflavones (as aglycones or~     glycosides) and food matrices can influence the bioavailability of these compounds in humans~     and hence their efficacy. To determine the effects of processing and food matrices on the~     bioavailability of active compounds derived from red clover the investigators will execute a~     5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40~     years. Participants will receive 5 different formulations of red clover and bioavailability~     will be monitored in blood plasma using LC-MS.~   "
60584|NCT02264210|"~     This phase II trial studies how well icotinib works in treating patients with completely~     resected stage IB NSCLC harboring EGFR mutation.~   "
60585|NCT02264197|"~     Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food~     on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety~   "
60586|NCT02264184|"~     Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose~     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability~   "
60587|NCT02264171|"~     Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose~     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability~   "
60588|NCT02264158|"~     Assessment of the influence of telmisartan, lacidipine and their combination on the QTC~     interval of the ECG~   "
60589|NCT02264145|"~     The study objective is to determine the effect of the ethanolic solutions inhaled from the~     Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat®~     (18.4 of ethanol) on the breath alcohol measurements in healthy volunteers.~      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,~     randomized, four-way-cross-over design is chosen. The randomization is balanced and~     stratified in accordance with predicted values of the volunteers of Total Lung Capacity~     (TLC)~   "
60590|NCT02264132|"~     The objectives of this study were to investigate relative BA at steady state and to~     investigate dose proportionality of pharmacokinetic parameters~      Relative BA at steady state:~        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.~        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.~      Dose proportionality of pharmacokinetic parameters:~      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.~   "
60591|NCT02264119|"~     Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under~     physiological conditions and with 40 mg Pantoprazole~   "
60592|NCT02264106|"~     To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological~     conditions and with 40 mg Pantoprazole~   "
60593|NCT02264093|"~     To investigate the effects on airway lumen of talsaclidine in combination with propranolol~     and of talsaclidine and propranolol given as monosubstances~   "
60594|NCT02264080|"~     Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a~     multiple dose to healthy adult male volunteers in double blind manner.~   "
60595|NCT02264067|"~     To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a~     single dose to healthy adult male volunteers in double blind manner.~   "
60596|NCT02264054|"~     Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.~   "
60597|NCT02264041|"~     Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the~     single dose pharmacokinetics of cilobradine~   "
60598|NCT02264028|"~     -  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral~          and intravenous administration in healthy volunteers~        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous~          administration to healthy volunteers~   "
60599|NCT02264015|"~     Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT~     analysis of ECGs), and pharmacokinetic parameters~   "
60600|NCT02264002|"~     Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion~     frequency (FFF), FFF method evaluation~      Safety, tolerability and pharmacokinetics of cilobradine~   "
60601|NCT02263989|"~     Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the~     conventional 40 mg telmisartan tablet~   "
60602|NCT02263976|"~     Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics~     (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium~     bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline~     (methacholine challenge at screening).~   "
60603|NCT02263963|"~     The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus~     abdominis plane block by assessing the demand of postoperative narcotic, length of hospital~     stay and incidence of postoperative complications.~   "
60604|NCT02263950|"~     This clinical trial will assess whether a medicine called artemether, currently used at a~     lower dose to treat malaria, could also be useful in treating cancer. For this trial, the~     medicine is given in a new way, as a spray under the tongue. This delivery has several~     advantages, including better absorption into the body and it may be easier for people to~     take. It will be prescribed to consenting patients with advanced solid tumours, every day~     for 4 months, either once or twice a day. (For this study 'advanced tumour' will mean there~     are no other effective standard therapy options available to the patient).~      The dose will be decided in Phase 1 of the study by initially testing 3 different doses of~     the medicine in up to 21 different cancer patients, to make sure it is not too toxic or~     causes any side effects.~      After this, the highest safe dose identified in the first phase will be tested in up to 66~     cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size~     of their tumour or slow down its growth.~   "
60605|NCT02263937|"~     This trial aims to collect pilot data to explore whether bilateral deep brain stimulation~     (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking~     impairments among individuals with Dementia with Lewy Bodies (DLB).~   "
60606|NCT02263924|"~     Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial~     to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in~     patients with moderate ischemic stroke.~      150 patients will be recruited. Half will receive mixed tocotrienol 200mg twice a day for 6~     months while the other half will receive placebo capsules.~   "
60613|NCT02263833|"~     This national study was a post-marketing surveillance study conducted in Korea from 29~     August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera~     (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated~     for safety/risk assessments and effectiveness. No specific study-related procedures are~     required. Participants were to be followed up as long as possible at the physician's~     discretion.~   "
60614|NCT02263820|"~     Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common~     cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and~     post-operative AKI. The development of CI-AKI after cardiac catheterization is associated~     with a significant increase in both short-term and long-term mortality and morbidities, as~     well as an increase in length of stay and cost.~      The only marker of renal function that has predictive ability is creatinine and it has~     significant limitations in identifying patients who will develop AKI. Therefore, a~     diagnostic test for predicting CI-AKI risk would have widespread clinical utility.~      The primary purpose of this study is to measure the association between baseline expression~     of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac~     catheterization.~   "
60615|NCT02263807|"~     Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included~     into a randomized prospective study. This study addresses two forms of treatment for~     recurrent patella dislocation. One group is offered reconstruction of the medial~     patellofemoral ligament (MPFL), the second group is offered a standardized training program.~     70 patients are evaluated in the study. 75 of those fulfilled the inclusion criteria and are~     included in the study currently.~   "
60616|NCT02263794|"~     Patients in London and Hamilton with severe asthma who are deemed eligible by a~     respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided~     or conventional bronchial thermoplasty using hyperpolarized noble gas imaging.~   "
60617|NCT02263781|"~     Evaluation of PREPL activity in healthy controls and known or possible PREPL deficient~     patients~   "
60618|NCT02263768|"~     Objectives: To assess the effectiveness of two recall intervals on dental caries incidence~     (primary outcome) in preschool children with low and moderate caries risk. The level of~     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)~     according to each interval will also be assessed. Methods: The sample will consist of 224~     children between 3-5 years of age, of both genders, with low and moderate caries risk~     according to the clinical criteria adapted from the Secretary of Health of São Paulo.~     Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical~     examination + orientation for oral health and diet on the recall of 12 months; and Group 2~     (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18~     months.~   "
60619|NCT02263755|"~     According to the World Health Organization about 1,400,000 deaths reported annually, are~     related to chronic liver disease. Chronic liver disease is very prevalent in South Korea,~     placing a large economic burden nationwide. Subsequently, an effective and systematized~     approach to managing chronic hepatitis is imperative in Korea.~      The natural history of chronic liver disease differs greatly according to race and~     ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean~     patients. Therefore, the investigators plan to establish a retrospective and prospective~     multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for~     various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a~     basis for the establishment and distribution of clinical guidelines for Korean patients with~     chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease~     Control (CDC), Korea.~      The investigators plan to collect 500 cases as have been advised by the CDC during the study~     period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past~     5 years, there have been about 800 subjects with chronic hepatitis B who have undergone~     liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to~     register available cases retrospectively from those who are available to agree to give~     written informed consent to participate in this study, and to register the remaining numbers~     of cases prospectively, according to the inclusion and exclusion criteria.~   "
60620|NCT02263742|"~     This project aims to study health outcomes of individuals with mental illness attending a~     co-located primary health care center in a mental health center. This study uses mixed~     methods to collect a range of information about who chooses to use what Wellness Center~     services and in what combinations, with what short and longer-term effects and with what~     outcomes.~      Based on participant interviews, identify barriers to and facilitators of access, service,~     and improvements in person-centered outcomes and elicit suggestions for enhancing health~     care outcomes and choice.~      Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to~     develop and pilot the effectiveness of a new peer-led community based intervention in~     enhancing access and choice and improving person-centered health outcomes.~   "
60621|NCT02263729|"~     The goal of this study is to determine safety and tolerability of Losartan when used for~     treatment of an acute grade II or III hamstring strain and determining the effect of~     losartan on recovery of hamstring muscle function. Subjects will be adults age 18-35 with~     grade 2 or 3 hamstring injury who participate in Level 1 athletics or have a similar~     physical work load (e.g. military personnel). Military personnel will only be recruited at~     Brookings Medical Institute. Subjects will undergo examination, MRI, and functional~     assessment before, during, and after 4 weeks of losartan (50mg QD) or placebo.~   "
60622|NCT02263716|"~     This study is to determine whether accelerometry can be used to measure physical activity~     occurring during routine clinical care in a diverse population of patients with medical or~     surgical critical illness.~   "
60635|NCT02263547|"~     Primary Objective To determine if colestipol hydrochloride tablets can accelerate the~     elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by~     colestipol dosing of 11 days. Total duration of the study is 40 days.~      Secondary Objectives To collect information on the pattern of side effects with use of~     colestipol hydrochloride after teriflunomide administration and to determine the best~     duration of therapy needed for adequate elimination~   "
60878|NCT02260388|"~     The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of~     the University of Kansas Medical Center, is to learn about the safety and effectiveness of~     nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory~     polyneuropathy (CSPN).~   "
60623|NCT02263703|"~     Genital HPV is the necessary cause for cervical cancer, as well as a major contributing~     cause of several other cancers and conditions. There are now effective vaccines against the~     main oncogenic HPV types, HPV16 and 18.~      Most research and discussion has focused on targeting the vaccine to young women and older~     adolescents. Based on this, a national free HPV vaccination program for adolescent girls~     commenced in 2007, in Australia. However, at the time of commencement, there had been no~     research on the use of this vaccine in immunosuppressed. Therefore, information on the~     immunogenicity, safety and duration of efficacy of HPV vaccine when administered to~     immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent~     HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity,~     followed for 5 years for duration of immunity.~   "
60624|NCT02263690|"~     92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups:~     proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival~     lidocaine (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their~     pain experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately~     following the injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients~     also graded the overall injection experience as Excellent, Very Good, Fair, Poor or Awful.~     The physician evaluated the patient's eye movement during intravitreal injection in three~     levels: none or minimal (0), not compromising the injection (1), compromising the injection~     (2).~   "
60625|NCT02263677|"~     Participants will be persons with type 2 diabetes who are likely to have fatty liver~     disease. The investigators think that this medication will reduce fatty liver.~      The investigators will use an MRS (a non invasive method using magnets) to evaluate liver~     fat before and after subjects take a diabetes medication. The investigators will also~     collect a small amount of blood to measure liver, kidney and hormone functions. This will be~     done 4 times. Also, at the time of the subject gets their first dose of medication they will~     have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and~     body composition).~      The goal of all of these studies is to determine whether the study drug lowers liver fat.~   "
60626|NCT02263664|"~     Microcirculatory alterations occur in critically ill patients and those undergoing major~     surgeries. The severity of perioperative microvascular alterations appear to be related to~     the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a~     subgroup of high risk surgical procedures which have the potential to significantly affect~     and impair microcirculatory function but this patient population has not been well studied.~     Esophagectomy surgery in particular produces a profound systemic inflammatory response which~     correlates with a number of adverse outcomes. It is likely, though unproven, that~     microcirculatory derangements may underly these phenomena. Though the study of~     microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available~     evidence at this point supports the following hypotheses; that microcirculatory derangements~     and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may~     be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification~     via specific therapies.~      We propose a prospective observational study to determine the effects of transthoracic~     esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria~     undergoing planned transthoracic esophagectomy via thoracotomy incision will be~     prospectively enrolled at The University of Virginia. Patients will be followed for 28 days~     or until discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal~     tissues will be performed using sidestream dark field (SDF) imaging using the CytoCam® by~     Braedius Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include~     an index of vascular density (perfused vessel density), an assessment of capillary perfusion~     (proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.~      Note: the CytoCam® will only take a series of images as consistent with a microscope of~     exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices~     Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)~     approval.~      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021~      Data from patient's medical charts before and after surgery (30 days post) will be used for~     elucidation of specific complications. We will use the cardiovascular and respiratory~     components of the SOFA score as independent measures of organ dysfunction. Acute kidney~     injury will be defined by the AKIN criteria as an increase of at least 50% above baseline~     serum creatinine and will be graded from stage 1 to 3.~   "
60627|NCT02263651|"~     The objective of this study is to compare quilting suture of the dead space without~     drainage of the pectoral area to conventional closure with drainage to prevent~     post-operative seroma requiring intervention (aspiration or surgical intervention) within 21~     days after mastectomy for breast cancer.~   "
60628|NCT02263638|"~     Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter,~     non-randomised, single-arm, open-label, phase II trial.~   "
60629|NCT02263625|"~     The aim of the present study is to investigate whether there are differences in indication~     for ventral hernia repair and surgical approach among hernia surgeons from different~     geographical regions of Denmark.~   "
60630|NCT02263612|"~     The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of~     present study is to use large-scale data from DHD to uncover risk factors for long-term (30~     days postoperative and later) readmission, reoperation, death and reoperation for recurrence~     after incisional hernia repair with use of a synthetic mesh.~   "
60631|NCT02263599|"~     The aim of this study is to evaluate on which indication patients are offered operative~     treatment for their ventral hernia, and to investigate the natural course of ventral hernia~     in the population of patients not offered operation.~   "
60632|NCT02263586|"~     Aim of the study is examining the incidence of the occurrence of hyponatremia during a~     Triathlon~   "
60633|NCT02263573|"~     The primary purpose of the protocol is to determine the effects of a new program of PEP'C~     PEP'C with constant load and intermittent recovery (PEP'C-R) on endurance parameters of~     older seniors.~      The study hypothesis: the investigators propose that PEP'C-R training offers a significant~     improvement in endurance parameters for older seniors.~      The secondary objectives are to determine the effects of PEP'C-R on maximal~     cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity),~     systolic and diastolic heart function, body composition (measured by impedance), biological,~     functional and cognitive functioning and quality of life.~   "
60634|NCT02263560|"~     Many neurological patients express enhanced deficits while walking in a dark room (or during~     the night): the supraspinal structures involved in this navigational deficit have not been~     identified yet. In this project, the investigators will study post-stroke gaits of human~     patients and compare them to those of a control population during a goal-oriented task~     performed in different visual conditions.~      The investigators want to test the hypothesis that during simple goal-oriented locomotor~     tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express~     navigational deficits.~   "
60894|NCT02260180|"~     The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of~     A-101 versus a vehicle control in the treatment of seborrheic keratosis.~   "
60636|NCT02263534|"~     Based on previous studies the single incision minisling is an easy less invasive procedure~     with fewer complications and cure rate similar to conventional midurethral slings in the~     treatment of female stress urinary incontinence. The aim of this study is to test the~     hypothesis that the single incision mini-sling placed in the U position is not inferior to~     TVT in this patient population.~   "
60637|NCT02263521|"~     Development and validation of a measure of physician work motivation.~   "
60638|NCT02263508|"~     Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors~     have disappeared, disease progression per modified Immune-Related Response Criteria (irRC),~     or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects~     will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease~     progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of~     study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus~     pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of~     the first dose of pembrolizumab or end of treatment due to disappearance of injectable~     lesions, complete response, disease progression per irRC-RECIST or intolerance of study~     treatment.~   "
60639|NCT02263495|"~     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective~     chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the~     preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a~     maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as~     shown in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin~     Oncol 31(14):1732, 2013).~      Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival~     benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of~     anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).~     Eribulin was also reported its promising efficacy in another randomized phase III study that~     demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS~     2012). Both study results showed potential clinical benefit in patients with triple negative~     MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for~     early line therapy in patients with metastatic breast cancer.~      Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of~     neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity~     profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in~     a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared~     to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.~      In phase I trial, eribulin in combination with gemcitabine was feasible in patients with~     advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).~      Based on this rationale, the investigators are to conduct randomized phase II study~     comparing EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as~     first-line chemotherapy.~      A total of 112 patients will be recruited. Patients will be randomized to a treatment arm by~     permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,~     open label study.~   "
60640|NCT02263482|"~     Heart failure is a clinical syndrome that is the common end of several cardiac diseases with~     symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve~     respiratory and general functional capacity of these patients, there are strategies that can~     be used such as inspiratory muscle training and peripheral muscle training (dynamic~     resistance training).~   "
60641|NCT02263469|"~     The objective of this study was to assess the safety and efficacy of Replenine®-VF in~     children enrolled in the study, under the age of six years, with severe haemophilia B.~   "
60642|NCT02263456|"~     The purpose of this study is:~        -  to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high~          purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.~        -  to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3~          months apart) and recovery if patients changes batches.~        -  to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with~          severe haemophilia B.~   "
60643|NCT02263443|"~     Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University.~     In our study we divide patients into 3 groups ,First group patients doing Soap suds enema~     (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non~     per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups~     and lower side effects in patients in no bowel preparation group.~      Research objectives~        1. Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of~          soap suds enema group, sodium chloride enema group and the NPO group in patients under~          going exploratory laparotomy in gynecologic surgery.~        2. Comparing the side effects of soap suds enema group, sodium chloride enema group and~          the NPO group.~      Inclusion Criteria~      1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult~     surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5.~     Consenting participants. Exclusion Criteria~        1. Pregnancy or suspected pregnancy.~        2. Laparoscopic surgery~        3. Do not consent to participate in research~        4. Gastrointestinal infection~        5. Underlying disease such as Intestinal disease, patient who cannot under going bowel~          preparation ,heart disease ,seizure.~        6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs from~          per vaginal examination or very huge mass or history of difficult surgery or history of~          severe adhesion in abdominal cavity.~   "
60644|NCT02263430|"~     Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment~     of different forms of chorea, including Huntington's disease (HD).~   "
60645|NCT02263417|"~     The purpose of this study was to compare the subthalamic nucleus(STN) with the globus~     pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically~     refractory dystonia.~   "
60646|NCT02263404|"~     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of~     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and~     healthcare costs. The study will help patients with severe AN using DBS. Individuals with~     severe intractable AN will be eligible to take part in the study.~   "
60647|NCT02263391|"~     This study gathers information about HIV testing utilization and influences on HIV testing~     decisions among young, general population Russian women at-risk of HIV exposure. The study~     compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in~     vs. opt-out) and conducts one of the first randomized experimental comparisons of these~     strategies. The overarching goal is to gain knowledge that can be used to increase~     utilization of HIV testing among at-risk young women and offer gender-specific strategies~     for improving prevention.~   "
60698|NCT02262728|"~     The purpose of this study is to assess the efficacy of a 12-week regimen containing~     simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the~     liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver)~     C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of~     study drug treatment (SVR12).~   "
60648|NCT02263378|"~     The purpose of this study is to evaluate whether a supplement in which ellagic acid plus~     annona muricata are combined, may modulate the immune response to high risk HPV infection.~     Sixty women will be enrolled in a randomized, controlled study, having a histological~     diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is~     the activation of onco suppressor protein by the supplement and secondary outcome is the~     clearance of HPV infection in the treated group.~   "
60649|NCT02263365|"~     Dehydration post creation of a diverting ileostomy is a common and debilitating problem~     faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel~     disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal~     cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers,~     may potentially have a delay in the adjuvant therapy when faced with this complication.~      Studies performed in this groups of patients report a readmission rate of 17-21% for~     dehydration.~      Loperamide has been shown to significantly decrease the daily volume of weight of stool in~     these patients.~      The purpose of this study is to establish whether loperamide given at 4mg three times daily~     for 14 days from day of discharge empirically decreases 30 days readmission rate for~     dehydration.~      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the~     readmission rates, that severity of dehydration will be decreased.~   "
60650|NCT02263352|"~     This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two~     months) as an adjunct to scaling and root planing in chronic periodontitis patients with~     type 2 diabetes mellitus.~   "
60651|NCT02263339|"~     The purpose of this study is to learn more about multiple sclerosis (MS). The investigators~     are studying whether aerobic exercise is better than a stretching program at improving brain~     health in people with MS. We want to learn:~        1. If it is safe and practical for people with MS to participate in an aerobic exercise~          program with the goal of increasing cardiac fitness. Cardiac fitness is measured with~          exercise stress tests at the beginning and end of the study.~        2. If aerobic exercise improves brain metabolism, a reflection of brain health, more than~          stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.~      There is a 50% chance of being in the aerobic exercise or the stretching program.~      There are between 8 and 36 visits to OHSU, depending on the intervention group. The total~     duration of the study is at most 21 weeks.~   "
60652|NCT02263326|"~     HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and~     plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of~     Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral~     regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of~     their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure~     defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24~   "
60653|NCT02263313|"~     In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in~     particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).~   "
60654|NCT02263300|"~     Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact~     on the development of fiberoptic intubation skills?~      Is it necessary to teach both orientations or is the supine view transferable to the upright~     position?~      Which method demonstrates longer skill retention?~      The hypotheses: Both orientations must be practiced and the upright skill is harder to learn~     but is retained for longer.~   "
60655|NCT02263287|"~     Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in~     autopsy series. However, DLB represents a small proportion of the clinical diagnoses in~     epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they~     share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis.~     DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor~     diagnostic value of both diagnostic criteria. To date there is still a need for a tool able~     to discriminate patients with pure DLB from those expressing common signs with both AD and~     DLB and those with pure AD. The purpose of this study is to validate a semi quantitative~     scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive~     decline. The investigators hypothesized that the score obtained may differentiate between~     AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also~     be correlated with dopaminergic depletion assessed with [18F]fluorodopa PET/computed~     tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This~     clinical validation is a preliminary work preceding further studies correlating the LeSCoD~     score with functional imaging features, prognosis and therapeutic response. Thus, the~     expected outcomes involve an improvement in demented patients' care, as well as a better~     patient selection for further therapeutic studies~   "
60656|NCT02263274|"~     The primary study objective is to measure the electrical fields evoked by tDCS using~     subjects who have implanted intracranial electrodes as part of their evaluation for epilepsy~     surgery. The measurements obtained in these subjects and their brain MRI will be employed to~     validate existing mathematical models.~      In the future, these refined models can be used to target tDCS to predetermined brain~     regions in healthy and subjects and patient populations. As described above in the safety~     section, the intensities of stimulation applied in this project are not expected to produce~     changes in brain function, are below intensities commonly applied in clinical trials, and~     fall well below safety limits suggested by animal studies.~   "
60657|NCT02263261|"~     Use of a HADM and implant in post-mastectomy breast reconstruction.~   "
60658|NCT02263248|"~     The Investigators are conducting a research study to learn about the safety and benefit of~     using a medication called buprenorphine for patient with difficult to treat depression .~     This research study is testing whether combining two medications will be effective in~     treating depression when initial treatment with just one antidepressant does not relieve the~     depressive symptoms ; this is what is called  difficult to treat depression  or ~     treatment resistant depression . The two medication the investigators are using are  an~     anti-depressant medication called venlafaxine XR ( the generic form of Effexor ) and~     buprenorphine . Buprenorphine is a medication that is FDA approved for the treatment of~     opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine~     enhances treatment response.~   "
60895|NCT02260167|"~     Treating with measures that may improve metabolic functioning of neurons in an integrated~     protocol~   "
60659|NCT02263235|"~     In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which~     represents, as in other developed countries, a major public health issue. In many cases, AD~     diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the~     diagnosis is however particularly important in the perspective of the validation and use of~     new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis~     biomarkers fell short in the detection, of atypical/mixed cases, of some differential~     diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis~     gives a unique opportunity to detect and validate biomarkers in many neurological disorders.~     Nevertheless, in medical practice, CSF biological analysis is currently limited to a small~     number of analytes.Quantitative and targeted mass spectrometry, especially operated in the~     Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and~     could be used to detect specific biomarkers in complex matrices such as plasma by~     specifically discriminating the proteotypic peptides corresponding to each proteins. Mass~     spectrometry has also the ability to distinguish and quantify isotopically labelled and~     unlabeled selected targets. This ability was used in a publication by the group of R.~     Bateman (Washington University, St Louis, USA) who could, after administering stable~     isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has~     an enormous potential to study the metabolism of proteins within the human CNS and~     consequently help in the understanding and diagnosis of neurological disorders.The main~     objective of this program is set up a targeted quantitative mass spectrometry method for~     existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this~     approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.~   "
60660|NCT02263222|"~     This is an open-label dose-escalating study to evaluate the tolerability and systemic~     exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary~     unilateral TKA.~   "
60661|NCT02263209|"~     Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard~     coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in~     cementless total hip arthroplasty~   "
60662|NCT02263196|"~     The purpose of this study was to compare the efficacy of combination of alcohol and povidone~     iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related~     to vascular access area in hemodialysis patients.~   "
60663|NCT02263183|"~     Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing~     to this special process, RPO possesses a special flavour and aroma, and is rich in~     phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene,~     phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents~     through which palm oil exhibits its nutritional properties. Among the major health promoting~     properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition,~     brain development and neuro-protective properties, antioxidative defence mechanisms,~     provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and~     health benefits, the potential of improved cardiovascular health should be considered to~     understand better and thus treasure more our golden oil.~   "
60664|NCT02263170|"~     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary~     consortium consisting of representatives ranging from clinical medicine via microelectronics~     towards biomaterial science aims to develop a novel implant to treat faecal incontinence.~     The aim of this campaign includes development of implantable prototype devices acting as~     artificial continence muscles using low-voltage electrically activated polymers (EAPs)~     controlled by implemented pressure sensors and the patient.~      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal~     sphincter complex are of cardinal importance. Most of the existing data on anatomy and~     physiology results is based on old studies and almost no data on biomechanical properties~     are available. However, new technologies or even merging data from different examination~     methods might provide new information in this field.~   "
60665|NCT02263157|"~     The study is designed to evaluate the association between nosocomial bloodstream infection~     and the occurrence of thrombocytopenia in surgical critical ill patients.~   "
60666|NCT02263144|"~     The purpose of this prospective, non-interventional study is to validate the Narrow Band~     Imaging International Colorectal Endoscopic (NICE) classification for differentiating~     subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color~     Enhancement (FICE) technology with high-definition without optical magnification.~   "
60667|NCT02263131|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG~     Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.)~     administered as a single intramuscular injection.~   "
60668|NCT02263118|"~     The purpose of this study was to determine whether exposure to m-health platforms promoting~     recommended breastfeeding practices was effective in transmitting the exclusive~     breastfeeding message to participant mothers, and in improving weight evolution of infants.~   "
60669|NCT02263105|"~     Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard~     treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive~     Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent~     high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT)~     activity and potentially capable of enhancing the antitumor effects of temozolomide (TMZ).~     Compared to the standard 5-day TMZ regimen, alternating weekly regimen that deliver more~     prolonged exposure of TMZ may lead to higher cumulative doses, and may deplete more~     O6-methylguanine DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells~     to TMZ.~      The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy~     and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent~     high-grade gliomas.~   "
60670|NCT02263092|"~     This study aims to understand metaplasticity through the association of transcranial direct~     current stimulation (tDCS) and physical exercise. For this purpose, the study will be~     separate in 2 phases: in the first phase the aim is verify the effects of physical exercise~     on cortical excitability. After this 1st phase two intensities of physical exercise will be~     chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and~     sham tDCS plus physical exercise.~   "
60671|NCT02263079|"~     This randomized, controlled, parallel group, open-label multicenter study will evaluate the~     efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus~     lamivudine or entecavir compared with an untreated control group in participants with HBeAg~     positive CHB in the immune tolerant phase.~   "
60672|NCT02263066|"~     To assess and describe real-life treatment choices for rFⅧ contained regular~     prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China~     (2007-2013)~   "
60673|NCT02263053|"~     The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is~     composed of the mandibular condyle is positioned within the glenoid fossa of the temporal~     bone, and the articular disk that separates these two bones. The normal biomechanics of the~     TMJ is the concave / convex relationship between the condyles and the articular disc. The~     movements of the TMJ joint are: mandibular depression and elevation (opening and closing of~     the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a~     musculoskeletal disorder of the masticatory system that affects over 25% of the population.~     Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain,~     reduce inflammation and restore normal motor functions. The physical therapy interventions~     taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall~     objective is to assess the immediate effects of previous mobilization versus flow amplitude~     of mandibular depression in patients with temporomandibular dysfunction. The type of study~     will be a randomized study of two parallel groups balanced distribution (1: 1) and~     double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of~     Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will~     consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to~     participate in the study due to symptoms of TMD. Data, anthropometry, application of~     Research Diagnostic Criteria for Temporomandibular Disorders will be collected. The~     physiotherapist responsible for the assessment before and after the interventions will be~     blind with respect to the distribution of the treatment groups. The patient will also be~     blind, because you will not know whether or caudal anterior mobilization was performed.~     Randomization codes are generated by computer using Random Allocation Software (version~     1.0.0) at a ratio of 1: 1 by a researcher not involved in the data collection. These codes~     will be placed in sealed, opaque envelopes being numbered consecutively, which will ensure~     the covert allocation of study participants. Our data are considered confidential as joint~     property of the parties involved.~   "
60674|NCT02263040|"~     The objective of this pilot study is to assess the immunogenicity and reactogenicity of~     Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare~     workers.~   "
60675|NCT02263027|"~     This study will recruit 35 healthcare workers who had systemic reactions to influenza~     vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed~     associated with systemic reactions in these workers.~   "
60676|NCT02263014|"~     The goal of this research study is to learn more about how different treatment decisions may~     influence the quality of life in women with breast cancer. Researchers want to use what is~     learned from this study to help future patients with breast cancer to be more informed when~     making treatment decisions.~   "
60677|NCT02263001|"~     Musculoskeletal injuries resulting in pain are one of the most common reasons for disability~     and missed duty among military personnel. Additionally, these injuries may create impairment~     in the area of optimal function, sleep and mood that may not be completely resolved with~     currently available therapies. This scenario creates the setting for testing and~     incorporation of additional treatment options to potentially improve care outcomes. Recent~     investigations have examined the adjunctive use of auricular therapy, which utilizes various~     interventions, typically needle-based, to stimulate the ear. This intervention appears to~     modulate the autonomic nervous system to produce more rapid onset of pain relief and~     reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy,~     active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged~     to outpatient care for treatment will be studied. Subjects randomized to auricular treatment~     will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months~     from a clinician trained in auricular therapy. This trial will specifically examine whether~     the addition of a specific auricular therapy protocol to standard care will have a~     beneficial impact on the pain and functionality of military personnel who sustain an acute~     or sub-acute musculoskeletal injury.~   "
60678|NCT02262988|"~     The purpose of this study is to assess the potential benefit of enhancing total knee~     arthroplasty (TKA) surgery using some of your own cells taken from fat tissue that may be~     able to help recovery and repair of knee tissues.~   "
60679|NCT02262975|"~     This study is an observational study conducted prospectively under routine clinical setting~     for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by~     donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected~     institutions of about 8 countries in Asia.~   "
60680|NCT02262962|"~     The purpose of this research is to design and test a new model for delivery of well-child~     care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators~     used an innovative expert panel and community advisory board process to develop this new~     model for the delivery of WCC to low-income families in partnership with our partner~     community pediatric practices. The new model of care utilizes a trained health educator, or~     Parent Coach at every well-visit from 0-3 years of age. The Parent Coach provides a range~     of services, including health education and guidance, developmental screening, and~     psychosocial screening and services. The Parent Coach works with the Primary Care Physician~     to ensure that the family's needs are met for that well-visit. As a part of this new model~     for well-child care, the parent also uses a web-based tool to help prioritize needs for the~     visit and complete any necessary pre-visit screening. Parents receive additional education~     and guidance from a text message service and have access to the Parent Coach outside of the~     visit.~      The randomized controlled trial (RCT) of this new model of care will include 250 families~     who will be enrolled at participating clinics if the child is under 1 year of age. Parents~     will receive the intervention for 12 months and will complete surveys to collect data on~     their experiences of care. Our hypothesis is that this new model of care will be more~     patient-centered and more effective in providing recommended preventive care services than~     usual care, and that it will be a sustainable and feasible model for the partner practices.~   "
60681|NCT02262949|"~     The purpose of this study is to assess the deliverability, clinical utility, safety and~     effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.~   "
60699|NCT02262715|"~     The purpose of this study is to investigate the drug-drug interaction between VX-787 and~     oseltamivir, when co-administered at steady-state in healthy participants. In addition the~     safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the~     blood and tissues over time) of VX-787 will be assessed.~   "
60700|NCT02262702|"~     The aim of this observational study is to compare the use of an extended release paracetamol~     formulation with standard paracetamol in a cohort of Australian concessional patients with~     osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.~   "
60896|NCT02260154|"~     Prospective, multicenter, non-comparative, observational program designed to assess the~     effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg BID and changes in quality of~     life in patients with post-cholecystectomy gastro-intestinal spasms~   "
60897|NCT02260141|"~     To study the effectiveness of d-ribose in treating Alzheimer's and Dementia~   "
60682|NCT02262936|"~     Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent~     in the elderly. Desmopressin is a treatment for nocturia but it can result in hyponatremia~     (low blood sodium), particularly in those aged 65 and older. Fesoterodine is used for the~     treatment of overactive bladder (OAB). Recent trials showed Fesoterodine was effective in~     reducing nocturia. This study aims to answer the following: In women 65 and older with~     severe nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of~     night time voids? Does Fesoterodine have a better side effect profile compared to~     Desmopressin?~      The study design is a 12 week randomized double-blinded trial of Fesoterodine and~     Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be~     conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day~     voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q)~     will be completed at baseline and at week 12. The primary outcome will be the number of~     night time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks~     after starting treatment. Secondary outcomes include changes in the NNES-Q scores and the~     safety of each medication.~      This study is expected to show that, in women 65 and older with severe nocturia,~     Fesoterodine will be more effective in reducing the number of night time voids, reducing the~     volume of voided urine, increasing the duration of sleep prior to first nocturnal void and~     improving quality of life relative to Desmopressin. Fesoterodine will also be better~     tolerated, with fewer significant adverse events, relative to Desmopressin.~   "
60683|NCT02262923|"~     Metoclopramide is a dopamine D2 receptor antagonist with antiemetic and gastrokinetic~     properties which has been approved for use in pregnant women. Women with polycystic ovary~     syndrome (PCOS) have been found to have lower dopaminergic tone and increased ovarian~     vascularity and vascular endothelial growth factor (VEGF) levels compared to controls.~     During ovarian stimulation, PCOS patients exhibit greater sensitivity to gonadotropins and~     increased follicular development. Administration of dopamine D2 antagonists may mimic the~     low dopaminergic tone noted in PCOS patients, increase VEGF levels, angiogenesis, and~     subsequently improve follicular growth during ovarian stimulation. This strategy could be~     used to improve IVF outcomes in poor responders.~      The investigators hypothesize that, compared to gonadotropin use alone, the use of~     metoclopramide in combination with gonadotropins in poor responders undergoing IVF will~     result in an increased number of mature oocytes obtained at oocyte retrieval and improved~     IVF outcomes.~   "
60684|NCT02262910|"~     The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to~     identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously to~     patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics~     (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of~     MOR209/ES414.~      The primary objective of Stage 2 of the study is to evaluate the clinical activity of~     MOR209/ES414 in patients that have or have not received prior chemotherapy. Secondary~     objectives are to further characterize the safety profile, PK, PD, and immunogenicity of~     MOR209/ES414.~   "
60685|NCT02262897|"~     Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis,~     even though the first line chemotherapy showing about 70% response rate. Most of the~     patients will relapse with in 6 months after the chemotherapy and the following therapy such~     as second line chemotherapy have a very limited efficacy to these patients. Currently, there~     is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).~      As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases~     report in the patients with SCLC, the aim of this clinical trial is to investigate the~     efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive~     disease and failed to first line/ second line chemotherapy.~   "
60686|NCT02262884|"~     A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE~     RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL~     INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL~     NEPHRECTOMY~   "
60687|NCT02262871|"~     Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit~     (ICU) admission because of acute exacerbation of chronic respiratory failure or for any~     acute deterioration of clinical status. Non-invasive ventilation (NIV) is the first option~     for the clinical management of CF patients with moderate-to-severe respiratory distress and~     NIV has been shown to improve gas exchange, reduce respiratory muscle work and improve~     pulmonary function in patients with obstructive lung disease in general and those with acute~     CF exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing~     heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides~     a small positive pressure, probably washes-out the pharyngeal dead space, reduces~     inspiratory resistance, and possibly facilitates secretion clearance. The technique is very~     well tolerated. From a physiologic standpoint, this device could help CF patients by~     improving gas exchange, reducing respiratory workload, and facilitating mucus clearance.~     Non-interrupted delivery may be possible given better clinical tolerance in contrast with~     bi-level positive pressure NIV. Whether the short-term physiological efficacy of HFN is~     comparable to NIV is unknown and there is no study on the benefit of HFN in CF patients.~      The aim of this study is to compare the physiological effects of HFN and NIV in CF patients~     requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as~     evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease~     dead space. In addition, comfort and preference between the two techniques will be~     evaluated.~   "
60688|NCT02262858|"~     Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide~     (HCTZ) fixed dose combination compared with its monocomponents~   "
60689|NCT02262845|"~     The purpose of this study is to document clinical utility and distribution of indications~     for short term pancreatic stenting, and stent type preference by indication at tertiary~     referral centers with expertise in pancreatic endotherapy.~   "
60736|NCT02262234|"~     Chronic pain (pain that is that is present for a long period of time) is very common among~     people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to~     treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI~     must find ways of accomplishing daily activities even though they have pain.~      The purpose of this research study is to determine how well two different kinds of education~     programs reduce the extent to which chronic pain interferes with daily life and well-being.~   "
60690|NCT02262832|"~     Background:~      - Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This~     can lead to health problems including diabetes. Researchers have found that the drug~     metreleptin improves health in people with this disease.~      Objective:~      - To test the safety and effectiveness of metreleptin.~      Eligibility:~        -  People ages 6 months and older with generalized lipodystrophy who:~        -  have received metreleptin through NIH studies AND~        -  cannot get it through approved or compassionate use mechanisms in their home country.~      Design:~        -  Participants will come to NIH approximately every 6 months during year one, then every~          1 2 years. Financial assistance may be available for travel within the U.S.~        -  At visits, participants will get a supply of metreleptin to take home for daily~          injections. They will have:~        -  plastic catheter placed in an arm vein.~        -  blood tests, urine collection, and physical exam.~        -  oral glucose tolerance test, drinking a sweet liquid.~        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on~          the skin and pictures are taken of the organs.~        -  echocardiogram, which takes pictures of the heart with sound waves.~        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen~          they breathe is measured.~        -  Participants will have up to 3 DEXA scan x-rays per year.~        -  Participants may have:~        -  annual bone x-rays.~        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a~          small piece. Participants will sign a separate consent for this.~        -  Participants must be seen regularly by their local doctors and have blood tests at~          least every 3 6 months at home.~   "
60691|NCT02262819|"~     Background:~      - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory~     system. Sometimes people who get sick with staph infection do not get better with standard~     treatment. These staph infections can be serious and even deadly. Researchers want to find~     out why some people are more likely to get the infection.~      Objectives:~      - To look at the immune response of the skin when it is exposed to bacteria.~      Eligibility:~        -  People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph~          infections.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may~          have additional tests if needed. If they had a recent biopsy, researchers may ask for a~          sample from it.~        -  Some participants will spend the night at the clinic. Their vital signs will be taken~          and they will have blood drawn. Some participants will take aspirin or ibuprofen~          starting 2 days before their stay.~        -  Some participants will have blisters created on the inside of their forearm. Suction~          will pull a layer of skin from their arm. Skin will be removed. Different solutions~          will be applied to the blisters. Up to 3 biopsies may be taken.~        -  Children will not have blood tests or biopsies.~        -  Participants will be called every day for 10 days, then at 30 days after the procedure.~        -  Participants will have a follow-up visit 10 days after the procedure.~        -  Participants who did not get blisters or biopsies will not have any follow-up~          appointments.~   "
60692|NCT02262806|"~     Background:~      - Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can~     lead to health problems including diabetes. Researchers have found that the drug metreleptin~     improves health in people with this disease.~      Objective:~      - To test the safety and effectiveness of metreleptin.~      Eligibility:~        -  People age 6 months and older with partial lipodystrophy who~        -  have received metreleptin through NIH studies and shown improvement AND~        -  cannot get metreleptin other ways.~      Design:~        -  Participants will come to NIH approximately every 6 months during year one, then every~          1 2 years. Financial assistance may be available for travel within the U.S.~        -  At visits, participants will get a supply of metreleptin to take home for daily~          injections, or it can be shipped to them inside the U.S. They will have:~        -  plastic catheter placed in an arm vein.~        -  blood tests, urine collection, and physical exam.~        -  oral glucose tolerance test, drinking a sweet liquid.~        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on~          the skin and pictures are taken of the organs.~        -  echocardiogram, which takes pictures of the heart with sound waves.~        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen~          they breathe is measured.~        -  Participants will have up to 3 DEXA scan x-rays per year.~        -  Participants may have:~        -  annual bone x-rays.~        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a~          small piece. Participants will sign a separate consent for this.~        -  Participants must be seen regularly by their local doctors and have blood tests at~          least every 3-6 months at home.~   "
60693|NCT02262793|"~     To investigate the relative bioavailability of telmisartan respectively of dipyridamole~     after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic~     acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to~     ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis®~     alone (Reference 2).~      To investigate the relative bioavailability of dipyridamole respectively of telmisartan~     administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)~     relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to~     telmisartan in Micardis® alone (Reference 2).~   "
60694|NCT02262780|"~     Group 1:~      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5~     and T80/H12.5)~      Group 2:~      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x~     7 days)~   "
60695|NCT02262767|"~     This study will test the hypothesis that PF-06649751 with continuous co-administration of~     trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of~     PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose~     projected to be under the current limits for drug concentration.~   "
60696|NCT02262754|"~     PF-06372865 In Subjects With Chronic Low Back Pain~   "
60697|NCT02262741|"~     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the~     safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of~     MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous~     cell carcinoma of the head and neck.~   "
60701|NCT02262689|"~     The study evaluates the effect of GSK2256294 exposure at steady state on pulmonary artery~     systolic pressure (PASP) in healthy volunteers, under hypoxic conditions, after 7 days of~     dosing. It is single centre, double blind, randomized, placebo-controlled study to be~     conducted in approximately 30 healthy volunteers. Subjects will be screened no more than 30~     days. Subject will be admitted in clinical unit on Day -1. Subject will be dosed for 7 days~     in unit in morning on all days except for dosing on Days 3 -6. Dosing on Days 3 -6 will~     occur at home. Subjects will return to the unit on the evening of Day 6 and remain there~     until Day 8. Subjects will undergo echocardiography under normoxic and hypoxic on Day 1~     pre-dose and on Day 7 post-dose. Subject will be followed up for 28- 32 days after~     discharge. The maximum estimated time that a subject will be enrolled in the study is 62~     days from the screening visit to follow up.~   "
60702|NCT02262676|"~     Depict demographic and clinical features of patients with atrial fibrillation treated with~     rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice~   "
60703|NCT02262663|"~     This is a study in healthy women of reproductive age to investigate the pharmacodynamics~     (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral~     administration of 4 different doses over 84 days, using a randomized, parallel-group,~     multicenter design.~   "
60704|NCT02262650|"~     Study to investigate the relative bioavailability of concomitant administration of~     clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone~     (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And~     to investigate the bioavailability of SR26334 following administration of clopidogrel 30~     minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334~     alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)~   "
60705|NCT02262637|"~     Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual~     daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the~     clientele of cardiologists, nephrologists, and diabetologists~   "
60706|NCT02262624|"~     To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.~     its monocomponents~   "
60707|NCT02262611|"~     Study to obtain long-term data on effects, safety and tolerability in routine medical~     practice and to investigate the potential of telmisartan to prevent secondary organ damage~   "
60708|NCT02262598|"~     To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg~     HCTZ vs. its monocomponents~   "
60709|NCT02262585|"~     Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277~     capsule~   "
60710|NCT02262572|"~     Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations~     based on sodium salt compared to the present commercial formulation (MicardisPlus®)~   "
60711|NCT02262559|"~     Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277~     capsule~   "
60712|NCT02262546|"~     The objective of the study is to assess that pramipexole does not prolong the QT interval~     more than placebo~   "
60713|NCT02262533|"~     The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics~     (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.~   "
60714|NCT02262520|"~     The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)~     of multiple-dose Digoxin in healthy subjects.~   "
60715|NCT02262507|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according~     to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs,~     LLC (Q30). Initial research suggests that the Device has the potential to reduce the~     likelihood of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions~     (OAE) is that the investigators need a physiologic, non-invasive method to evaluate the~     brain responses to mild jugular compression across multiple age groups. To determine this~     with MR imaging is currently cost prohibitive. The investigators pilot data from the parent~     IRB indicates a consistent response measured via wideband absorbance in young adults.~     Therefore, a preliminary step to evaluate the safety and efficacy of the neck collar device~     is to employ this technology across a wide range of ages.~   "
60716|NCT02262494|"~     The main objective of our study is to determine the diagnostic performance of an~     ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by~     experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients~     with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed~     by a vascular exploration expert.~   "
60717|NCT02262481|"~     The purpose of this study is to evaluate the effect of oral progesterone supplementation in~     preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy~     period, and its side effect.~   "
60718|NCT02262468|"~     assess results of metal on metal hip replacements carried out at warwick hospital~   "
60719|NCT02262455|"~     This is a Phase I study to test the safety, pharmacokinetics and effectiveness of STM 434~     alone, or in combination with liposomal doxorubicin, in patients with ovarian cancer or~     other advanced solid tumors.~   "
60720|NCT02262442|"~     The aim of this prospective study is to examine the benefits and risks of administration of~     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)~     during flexible bronchoscopy.~   "
60721|NCT02262429|"~     Newly admitted patients will be screened for risk of malnutrition. Patients will receive~     either the feeding protocol or current oral nutrition supplement (ONS) practice, pending~     location. Patients will continue the nutrition plan taking the supplement post discharge.~     Study team will follow-up with telephone calls to help support post-discharge ONS~     compliance. Quality and service utilization data will be gathered for analysis.~   "
60929|NCT02259725|"~     This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that~     have spread from the primary site (place where it started) to other places in the body.~     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
60722|NCT02262416|"~     In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for~     infertility that involves controlled ovarian hyperstimulation, egg maturation, egg~     collection, fertilisation, embryo culture and finally embryo transfer. The period after egg~     collection is called luteal phase. In Australia, vaginal progesterone is routinely used to~     support the lining of the uterus so that it is susceptible to implantation of the embryos.~      More recently, there has been some suggestion that additional supplementation of luteal~     phase with GnRH agonist increases clinical pregnancy and live birth rate. These studies are~     however heterogeneous and results were inconsistent.~      This study is a prospective randomised controlled trial of additional GnRH agonist in luteal~     phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number~     of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate,~     on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation~     rate and multiple pregnancy rate.~   "
60723|NCT02262403|"~     The main objective of this study is to characterize the regulatory immune response induced~     by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution~     after infection treatment and during potential naturally reinfection.~   "
60724|NCT02262390|"~     2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are~     infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had~     adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and~     others have shown that syphilis screening integrated into an HIV antenatal clinic with~     prevention of mother to child transmission (PMTCT) is highly accepted with excellent uptake.~     Unfortunately, the minority of male partners come in for testing and treatment (1%-27%)~     which has important implications for the roll-out of rapid syphilis testing and the~     inability to detect reinfection with treponemal antibody test as the test will remain~     positive despite treatment. The investigators hypothesize that sending an SMS reminder or a~     telephone call reminder by a health care worker will be more effective than a standard~     notification slip given to women to bring male partners to antennal clinic for testing and~     treatment.~   "
60725|NCT02262377|"~     The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV)~     are effective for treating patients with chronic pain and depression.~   "
60726|NCT02262364|"~     The primary objective of this study is to assess the safety of a single injection of APS.~   "
60727|NCT02262351|"~     Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment~     of AF is one of the best way to prevent stroke. The problem is that because AF may cause~     minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is~     known that as many as half of all patients with known AF may not be receiving appropriate~     anticoagulation for their condition. New technologies are making it possible to improve AF~     detection. Subjects in this study will be screened for AF using three simple methods: a~     30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood~     pressure monitor with built-in AF screening capabilities. If more patients with AF can be~     detected, more patients will be able to receive guideline-recommended anticoagulant therapy,~     and more strokes, deaths, disability, and dementia will be prevented.~   "
60728|NCT02262338|"~     AGT-182 is a fusion protein containing idursulfase that is intended to deliver the enzyme~     peripherally and to the brain, when administered intravenously. This study is a safety and~     dose ranging study to obtain safety and exposure data, as well as information on the~     biological activity of the investigational drug.~   "
60729|NCT02262325|"~     This phase II trial studies how well giving a hypofractionated boost to the primary tumor~     before standard chemotherapy and radiation therapy works in treating patients with stage II~     or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation~     oncology have allowed better radiation targeting which may be able to send x-rays directly~     to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and~     targeted radiation before standard chemotherapy and radiation therapy may kill more tumor~     cells and prevent the cancer from coming back in the location in which it started.~   "
60730|NCT02262312|"~     Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often~     suffer from anemia. This can lead to red blood cell transfusion dependency and iron~     overload. Iron overload can affect the liver and lead to liver fibrosis and worst case~     cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients~     will have a transient elastography performed which measures the liver's stiffness. The~     purpose is to investigate whether liver stiffness measurements are coherent to ferritin~     levels.~   "
60731|NCT02262299|"~     A European multi-centre, randomised, double-blind placebo-controlled trial of Pirfenidone in~     bronchiolitis-obliterans-syndrome grade 1-2 in lung transplant recipients.~      Randomized double blinded, placebo controlled study. Eligible patients are to be randomized~     in a 1:1 ratio to receive either Pirfenidone 2403 mg/d or the matching placebo treatment for~     6 months.~      Primary objective To evaluate the effect of Pirfenidone on the change in FEV1 in liters over~     6 months in lung transplant recipients with bronchiolitis obliterans syndrome.~   "
60732|NCT02262286|"~     Procure blood specimens from individuals presenting to the emergency department with~     suspected brain injury.~   "
60733|NCT02262273|"~     This study will be carried out as a retrospective, non-interventional observational review~     of medical records for patients in multiple countries with platinum-sensitive recurrent~     serous ovarian cancer. The objectives are to describe in a real-world population, treatment~     patterns, BRCA mutation testing and results, overall survival, health care utilization and~     also to estimate rates of selected treatment- and/or disease-related side effects~   "
60734|NCT02262260|"~     To explore a more clinical feasible treatment regime with ranibizumab for DME to provide~     satisfactory treatment effect with a lower number of visits and injections.~   "
60735|NCT02262247|"~     The objectives of this study are to evaluate the performance of the Medrobotics Flex®~     Robotic System to visualize and access specific anatomical locations along with evaluation~     of the safety of the device.~   "
60737|NCT02262221|"~     Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up~     programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1~     month) after curative treatment will be randomized in two arms according to 2 different~     follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic~     evaltuations scheduled, but required only at the occurence of any signs or symptoms and~     Intensive Follow up approach (Arm B) with scheduled radiologic evaluations.~   "
60738|NCT02262208|"~     The aim this study is characterize glycemic variability using linear and nonlinear~     mathematical tools, under basal conditions and in response to specific protocols acute~     exercise that evoke oxidative stress and inflammation in healthy subjects and type 2~     diabetes patients. For this purpose, the sample size will consist of 37 individuals healthy~     and 32 without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly~     performed aerobic and eccentric sessions, both in the morning (24h after CGMS placement),~     and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation,~     glucose variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of~     variation (conventional methods) as well as by spectral and symbolic analysis~     (non-conventional methods). Physiological mechanisms altered by exercise protocols (Human~     Soluble Interleukin-6 and Glutathione), will be measured in blood samples.~   "
60739|NCT02262195|"~     The purpose of the study is to determine if a new pulse oximeter accurately detects~     carboxyhemoglobin and methemoglobin when intentionally increased in the blood.~   "
60740|NCT02262182|"~     Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac~     surgery. Classically, the treatment of these patients is based on manual chest~     physiotherapy. Our objective is to evaluate the interest of association of positive end~     expiratory delivery sessions with the EzPAP® device. We perform a prospective monocentric,~     open label trial. Patients with atelectasis after scheduled cardiac surgery with~     cardiopulmonary bypass are included. They benefit from manual chest therapy and are~     randomised to receive or not positive end expiratory pressure sessions twice a day. The~     primary endpoint is the effect of this treatment on atelectasis radiological score after 2~     days of treatment. The secondary endpoints are: oxygen saturation(SpO2)/inspired~     oxygen(FiO2) ratio, qualitative evaluation of ventilatory function, respiratory & cardiac~     rate, pain, inspiratory pressure (sniff test), patient satisfaction, duration of intensive~     care unit (ICU) and hospital stay.~   "
60741|NCT02262169|"~     This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using~     DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole~     at a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for~     the treatment of patients with any non-bleeding peptic ulcers.~      DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii,~     locally known as kayu manis have been proven at cellular and genetic levels to have an~     antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal~     protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+~     ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus~     suppressing gastric acid secretion; while its gastro-protective defense mechanism works~     through the promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating~     gastric-epithelial mucous and bicarbonate secretion; anti-oxidative activity; and~     endothelial-nitric oxide (NO) formation.~      Recent study of DLBS2411 in healthy volunteers demonstrated the effective role and safety of~     DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is~     hypothesized to benefit in peptic ulcers.~   "
60742|NCT02262156|"~     The aim of the study is to compare the effect of group-cognitive-behavioral therapy~     (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline,~     in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.~   "
60743|NCT02262143|"~     Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus~     rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,~     double-blind, phase 3 study~   "
60744|NCT02262130|"~     Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and~     with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual~     treatment, leading to a large impact on quality of life. New treatment options are~     warranted. The investigators aim to test the efficacy and the safety of omalizumab, an~     anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.~   "
60745|NCT02262117|"~     A prospective, randomized, controlled, open two-arm study to evaluate the interest of the~     pre-conceptional endometrial immune profiling to increase birth rates.~   "
60746|NCT02262104|"~     The purpose of this study is to investigate the effect of an exercise program on nursing~     home patients with dementia.~   "
60747|NCT02262091|"~     The aim of this research is to assess the immune enhancing property of food fibers in the~     elderly population.~   "
60748|NCT02262078|"~     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that~     has no proven effective treatment. This study will assess the effects of nebulized inhaled~     nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred~     to the catheterization lab.~   "
60749|NCT02262065|"~     Assessment of cytokine polymorphisms in 100 patients with aseptic complications to~     arthroplasty as compared to 100 symptom-free arthroplasty patients.~      In selected patients additional in-vitro cytokine release assay with peripheral blood~     mononuclear cells (PBMC) stimulated with different wear particles.~   "
60774|NCT02261740|"~     The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat~     pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report~     persistent or recurrent pelvic or genital pain for at least 6 months that interferes with~     sexual activity will be recruited from the San Francisco Bay Area. Those who meet~     eligibility criteria will take part in a 6-week yoga therapy program designed by an expert~     yoga panel. Women will attend twice-weekly group classes focusing on Iyengar-based yoga~     techniques that have been carefully selected for their potential to improve women's~     genito-pelvic pain and practice yoga at home one additional hour a week.~      The investigators will evaluate changes in the severity and impact of women's pain using~     validated questionnaires and diaries.~   "
60750|NCT02262052|"~     The Theia-study is a prospective, multicenter, single-arm management (cohort) study.~      Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep~     vein thrombosis (DVT), who fulfil all the inclusion criteria and meet none of the exclusion~     criteria, are eligible for inclusion and will be managed according to the result of a~     magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be~     performed and adjudicated within 24 hours of study inclusion. The final treatment decision~     will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients~     will be treated with therapeutically dosed anticoagulants. Patients with a negative MRDTI~     ruling will be subjected to a standardized compression ultrasonography (CUS) within 48 hours~     after initial presentation. The latter CUS serves as a reference test in case the patient~     returns with symptoms of ipsilateral recurrence in the future, and will not be used for~     management decisions at baseline. The study flowchart can be found in Appendix A.~      All patients will be followed for three months for the occurrence of acute recurrent venous~     thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including~     either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be~     performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up,~     MRDTI will be repeated.~   "
60751|NCT02262039|"~     The purpose of this study is to determine if the Airseal System will reduce post-operative~     pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.~   "
60752|NCT02262026|"~     Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and~     Pavlovian-to-instrumental transfer (PIT), part II Saracatinib~   "
60753|NCT02262013|"~     Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the~     feasibility of this dietary intervention strategy and preliminary effectiveness of two~     models of parental involvement within adolescent obesity treatment.~   "
60754|NCT02262000|"~     This study will help researchers learn about the best dose of radiation to be used when~     treating large early stage non-small cell lung cancer (NSCLC) with a treatment called~     stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage~     NSCLC show positive response. But, for large early stage NSCLC it may be better to give~     different SABR doses than what is used in routine early stage NSCLC treatment. It is not~     understood which dose is best for treating large early stage NSCLC. Therefore, this study~     can help researchers learn if giving a higher dose using SABR over a period of 5-10~     treatment days can increase the chance of cure for large early stage NSCLC.~   "
60755|NCT02261987|"~     This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed~     previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus~     clearance during a typical bronchial drainage session in adults, stable CF patients.~   "
60756|NCT02261974|"~     Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design~      The objective of this study is to determine the safety and effectiveness of the Viveve~     System to treat the vaginal introitus in women following vaginal birth(s) and in so doing~     improving vaginal laxity.~   "
60757|NCT02261961|"~     The loss of muscle mass and strength due to aging leads to serious health problems for older~     adults. Muscle health can be improved by exercise training, but some people improve their~     strength substantially, whereas others improve little. The reason for this variation is~     unknown. This study will investigate whether function of the immune system influences how~     well people respond to exercise. Older Veterans who participate will have their muscle size,~     strength, and function measured periodically for almost a year. Participants will drink a~     nutritional supplement or placebo daily and complete a 36 session strength training program.~     Participants will be vaccinated for tetanus and donate small amounts of blood and muscle~     tissue during the study so that immune function can be compared to muscle outcomes during~     training and during a long-term follow-up. The study results should increase the~     investigators' understanding of the negative effects of aging on muscle and will possibly~     lead to better strategies for muscle maintenance and rehabilitation for older adults.~   "
60758|NCT02261948|"~     The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary~     exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients~     with severe heart failure in stable clinical conditions (NYHA - New York Heart Association -~     class III, with a peak VO2 (Oxygen consumption ) < 12 ml/min/kg) on top of optimized~     standard therapy.~   "
60759|NCT02261935|"~     In this project the investigators will train home care nurses to use the Carer Support Needs~     Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then~     compare the family caregivers' quality of life, burden and other outcomes to a group of~     family caregivers whose home care nurse is not using the CSNAT (control group). Findings~     will allow us to determine the effectiveness of using the CSNAT as a tool to identify,~     monitor and address family caregiver support needs in palliative home care.~   "
60760|NCT02261922|"~     To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated~     dilation of the brachial artery. This will be compared to prasugrel.~   "
60761|NCT02261909|"~     NephroCheck is measuring the concentration of a certain protein combination in the urine of~     patients. In elevated values there is a probability of renal failure (already proven in~     intensive care patients). The investigators would like to investigate whether the~     investigators can predict renal failure in patients receiving contrast enhanced CT's in the~     emergency department. That would lead to an earlier nephrologist consult in those patients.~   "
60762|NCT02261896|"~     The purpose of this study is to determine whether the use of antibiotic prophylaxis is~     appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic~     ultrasonography.~   "
60763|NCT02261883|"~     This pilot study aims to assess the safety and treatment effect of acute dosing with IV~     Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).~   "
60790|NCT02261532|"~     The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after~     single and multiple dose in Chinese patients with solid tumor.~   "
60898|NCT02260128|"~     Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel~     function. This study evaluates whether chewing gum can reduce the bowel paralysis after~     surgery in patients undergoing either esophageal resection or whipples procedure. Half the~     study population will receive chewing gum while the other half will act as control.~   "
60764|NCT02261870|"~     The investigators propose a simple and non-invasive method to monitor heart transplant~     patients with MRI. Its diagnostic and prognostic values have already been assessed in two~     monocentric studies. Other monocentric studies based on related methods have confirmed the~     investigators findings. These studies are insufficient to allow a large diffusion of the~     technique. Only a large multi-centric study will change medical practices. In addition, this~     project will spread the new method at a national level and will allow an assessment of its~     practical usefulness in centres not familiar with MRI T2 quantification.~      Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of~     this observation could lead to a modification of diagnostic criteria of cardiac graft~     rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on~     biopsy with one based on a first-line MRI (with biopsy only when needed) for a more~     efficient and earlier detection of rejection. This would constitute a major advance in~     patients security and comfort as well as an economic improvement.~   "
60765|NCT02261857|"~     The purpose of this study is to determine whether patient-specific computer-aided design~     (CAD) and three-dimensional (3D) printing can be utilized to produce personalized, effective~     continuous positive airway pressure (CPAP) masks for children with severe obstructive sleep~     apnea (OSA) and craniofacial anomalies who encounter significant difficulty using CPAP~     because of poorly fitting masks despite exhausting available commercial mask options.~   "
60766|NCT02261844|"~     The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a~     beneficial effect in the cellular function of normal liver cells and diseased liver cells~     (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes~     based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional~     supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and~     proliferation of cancer cells, 3)decrease inflammation in the liver.~   "
60767|NCT02261831|"~     The investigators will compare 16sRDNA profile in cases and controls in order to identify~     bacteria associated with metabolic diseases that reside both in intestinal crypts and in~     blood.~   "
60768|NCT02261818|"~     Can peer mentors be integrated into depression care to older adults with mental health~     professional supervision? We will assess whether peer mentors who are lay persons who are in~     recovery from depression can provide depression care services to older adults with~     depression. Older adults who are 50 and older will be screened for depression in the clinic~     and community. Those who meet criteria will be paired with a peer mentor for 8 meetings.~     Peer mentors will audiorecord their meetings with the patient and the recordings will be~     analyzed to assess what kinds of communication and behaviors the peer mentors engage in and~     what among those communications may be associated with relieving depression. The peer mentor~     will be trained and supervised by a psychiatrist and they will form a team to provide the~     depression care to the older adult. The study aims to relieve depressive symptoms and engage~     older adults in care. Both older adults and peer mentors wil be interviewed after the study~     to assess the strengths and weaknesses of peer mentor delivery of depression care. A manual~     will be developed describing the process and procedures of the study.~   "
60769|NCT02261805|"~     This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and~     doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the~     study is to determine the recommended phase II dose of ganetespib when given in combination~     with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation~     phase will be used to conduct a safety dose expansion phase in relapsed/refractory small~     cell lung cancer to determine if there is a signal of efficacy in this population.~   "
60770|NCT02261792|"~     Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of~     cerebrospinal fluid. There are not controlled studies for this treatment.The main of this~     study is to demonstrate the superiority of the Trendelenburg position compared to supine~     position during 24 hours after an epidural blood patch for a spontaneous intracranial~     hypotension~   "
60771|NCT02261779|"~     Longterm disease-free survival (DFS) of older patients with acute myeloid leukemia (AML)~     remains poor. The vast majority of AML patients relapses within two years after start of~     therapy1,2. In Acute Promyelocytic Leukemia (APL, AML M3), all-trans-retinoic-acid (ATRA;~     Tretinoin) induces differentiation and subsequently clinical remission. So far effective~     differentiation therapy does not exist in other AML subtypes. Recent preclinical data~     suggest that the combinatorial use of ATRA and tranylcypromine (TCP), an irreversible~     Monoamine-Oxidase (MAO) and Lysin-specific demethylase (LSD) inhibitor that also inhibits~     LSD1 (a histone H3 Lysine 4 demethylase), induces leukemia cell differentiation and leukemic~     stem cell exhaustion in vitro and in vivo in non-APL AML subtypes.~      In this Phase I/II study the investigators will explore the feasibility, safety, as well as~     efficacy and of Tretinoin/TCP treatment in patients with relapsed or refractory AML or in~     patients with AML who are not eligible for intensive treatment. Patients will be treated~     with daily increasing doses of TCP (initially 10 mg/day, then +10 mg each day up to 80mg/d).~     After 7 days, ATRA will be added at a fixed dose (45 mg/sqm/day). Overall, 16 evaluable~     patients are going to be treated. The primary endpoint is the fraction of patients that~     achieve CR, CRp( complete response with incomplete recovery of platelets), CRi (complete~     response with incomplete recovery of granulocytes) and PR. Secondary endpoints are~     tolerability, safety as well as progression-free survival and overall survival. Serum levels~     of TCP will be regularly analyzed. Pharmacodynamic analyses will be performed with analyses~     of the inhibition of LSD1 by TCP. Further analyses will address the changes in Histone H3~     lysine 4 tri demethylase (H3K4me3) levels in AML blasts and the differentiation status of~     AML blasts.~      Taken together, this Phase I/II study will analyze feasibility, pharmacodynamics and~     effectivity of ATRA and TCP as differentiation therapy in AML.~   "
60772|NCT02261766|"~     This study will compare the two methods 5 days holtermonitoring and 30 days thumb~     electrocardiogram for detection of atrial fibrillation in stroke patients~   "
60773|NCT02261753|"~     The investigators are undertaking the first European Randomised Controlled Trial (RCT) for~     epilepsy surgery in children with FCD type II, to prospectively evaluate the role of the KD~     prior to surgery in improving seizure outcome. The investigators will evaluate the role of~     KD as a disease-modifying treatment to achieve seizure control and improve neurodevelopment~     and quality of life. Children age 5 - 15 years with pharmacoresistant epilepsy believed to~     be the result of focal cortical dysplasia type II, considered to be surgically treatable,~     will be randomised to either receive 6m treatment presurgery with a ketogenic diet, or to~     proceed direct to surgery (no pretreatment). Primary outcome will be the time to achieve a~     period of 6 months of seizure freedom from the date of randomisation. Tissue resected at~     surgery will also be evaluated with regard to the degree of any methylation of DNA.~   "
60922|NCT02259816|"~     Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in~     combination with repeated doses of 10 mg amlodipine~   "
60775|NCT02261727|"~     The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to~     assess the effect of low dose theophylline, singly and in combination with low dose oral~     prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life~     and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of~     treatment. Approximately 2400 symptomatic patients with COPD will be recruited in China for~     comparison of low dose theophylline versus placebo and low dose theophylline + low dose~     prednisone The primary end-point for this study is the difference between the three~     treatment groups in~        -  COPD exacerbation rate~        -  Time to first severe exacerbation requiring hospitalisation or death~   "
60776|NCT02261714|"~     The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage~     colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and~        -  Understand any possible side effects of the additional use of TG01/GM-CSF with~          gemcitabine~        -  Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune~          response~        -  Investigate if the treatment can delay or reduce recurrence of the disease~   "
60777|NCT02261701|"~     A new postoperative regimen with a new bandage technique after surgery results in a better~     shoulder function and quality of life after surgery - than traditional postoperative regimen~     with shoulder lock and abductor cushion.~   "
60778|NCT02261688|"~     The overall goal of this study is to evaluate the association between sodium and TH17 cells~     in human subjects. The subjects will have levels of TH-17 and various hormones measured on~     low salt diet, low salt diet with intravenous normal saline, and high salt diet.~   "
60779|NCT02261675|"~     The study was designed to define the interaction of intravenous infusion of dexmedetomidine,~     an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum~     alveolar concentration which can block adrenergic and cardiovascular responses to~     incision(MACbar) of sevoflurane as the measure of anesthetic potency.~   "
60780|NCT02261662|"~     This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV~     infection. The study will be done at Tropical medicine department , Tanta university. It~     will be conducted between June2014 and November 2014.~      The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous~     extrahepatic manifestations of HCV infection.~   "
60781|NCT02261649|"~     The purpose of the study is to evaluate how cerebellar resection surgery may affect pain~     sensation and the way the brain reads pain signals. By measuring brain activity in~     children and adolescents following surgery, the investigators hope to gain valuable~     information about pain processing in the brain.~   "
60782|NCT02261636|"~     For both induction of remission and in maintenance of remission, different doses and~     treatment durations are used in practice. The aim of this study is to assess how mesalazine~     is used in clinical practice, at which doses and for how long and how these differences~     impact the patient disease state and work productivity.~   "
60783|NCT02261623|"~     The purpose of this study is to document stent functionality and practice patterns in Canada~     pertaining to indications for use and stent type selection for self-expanding biliary metal~     stents (SEMS) when used per standard of practice.~   "
60784|NCT02261610|"~     The clinical manifestations of pulmonary embolism vary greatly from the absence of specific~     clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by~     lung superinfection, also called pulmonary embolism superinfected is common and~     represents up to 30% of initial clinical presentations; she been few evaluations in clinical~     research. The reality of the bacterial infection remains controversial and the clinical~     presentation often leads to the prescription of empirical antibiotic therapy, often~     unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.~      Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al~     reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism~     without actually clarified whether this was related to temperature with a pulmonary embolism~     or other associated cause. Murray et al estimated that greater than 38 ° C was explained by~     pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had~     fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism~     is often low intensity (often less than 38.3) and of short duration, with a peak on the day~     of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever~     in pulmonary embolism has not yet was completely clarified. It is suggested that a~     combination of several factors involved pyrogenic myocardial tissue necrosis and releasing~     pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or~     local superinfection.~      Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in~     patients with community-acquired pneumonia. This is especially verified in patients admitted~     for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT~     reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring~     biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.~      The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of~     interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial~     infections febrile forms of EP to other causes.~   "
60785|NCT02261597|"~     The main purpose of this study is to understand how insomnia (compared to good sleep) may~     affect the response of the body to a repeated physiological challenge, such as inserting the~     hand in ice-cold water for several times in a row. In particular, the investigators are~     interested in the response of markers that can be associated with stress, such as blood~     pressure and stress hormones.~   "
60786|NCT02261584|"~     The aim of this study is to compare microwave thermal coagulation and partial splenic~     embolization in the management of hypersplenism in patients with cirrhosis.~      This study will be conducted on 40 patients with liver cirrhosis associated with~     splenomegaly and hypersplenism. The study will be done at the National Hepatology and~     Tropical Medicine Research Institute.~   "
60787|NCT02261571|"~     Most cancer patients experience multiple symptoms related to chemotherapy and use CAM~     (complementary and alternative medicine) as an adjunct to conventional treatment.~     Moxibustion is traditional Korean medical therapeutic method and uses the heat generated by~     burning herbal preparations containing Artemisia vulgaris to stimulated acupoint.~      Herein, the investigators propose an open-label pilot study investigating the effectiveness~     of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under~     chemotherapy.~   "
60788|NCT02261558|"~     This study will investigate the impact of music therapy on newly diagnosed patients with~     cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle~     will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety~     depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis~     Scale).~   "
60789|NCT02261545|"~     The aim of this study is to determine the effects of supplementation with n-3 fatty acid or~     placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral~     blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of~     type2 diabetes patient~   "
60791|NCT02261519|"~     The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen®~     (sodium benzoate) in improving the negative symptoms of schizophrenia in adults. The trial~     is designed as a multi-center, prospective, randomized, placebo-controlled, Sequential~     Parallel Comparison Design (SPCD) study, in which adult subjects with schizophrenia will be~     enrolled. The study will include two parts: a 19-week, double-blind portion and a 26-week~     open-label extension portion.~   "
60792|NCT02261506|"~     Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although~     bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most~     commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin~     and soft tissue sources), because of the high attendant morbidity and mortality of~     bacteremia, these patients collectively represent a critically important group to study.~      The consequences of the excessive antimicrobial use for individual patients, range from~     rash, gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic~     epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One~     particularly concerning complication, Clostridium difficile infection, has increased in~     incidence and severity over the past decade. Much of this burden could be prevented through~     reduction in unnecessary antibiotic use.~      Another major consequence of excessive antibiotic use is antimicrobial resistance.~     Antibiotic resistance is not only a concern for the patient who receives antibiotics, but~     also for neighbouring patients in the ICU, as well as future patients in the ICU and the~     hospital at large - through patient-to-patient transmission, and environmental~     contamination.~      No previous randomized controlled trials have directly compared shorter versus longer~     durations of antimicrobial treatment in these patients. The investigators will conduct a~     multi-center randomized concealed allocation trial of shorter duration (7 days) versus~     longer duration (14 days) antibiotic treatment for critically ill patients with bacteremia~     admitted to ICU. Eligible, patients will be randomized to either 7 days or 14 days of~     adequate antimicrobial treatment. The selection of type, dose and route of antibiotics will~     be at the discretion of the treating physicians, but the duration of treatment (7 versus 14~     days) will be determined by randomization group. The randomization assignment will not be~     communicated to the study research coordinator, study critical care or infectious diseases~     investigators or clinicians until day 8. The primary outcome for the main trial will be~     90-day mortality.~      The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and~     then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These~     sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional~     funds are obtained the investigators will also roll out to the other Canadian ICUs listed~     below. The goal of adding these additional sites will be to increase the generalizability of~     the findings with respect to trial feasibility~   "
60793|NCT02261493|"~     This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial~     rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).~   "
60794|NCT02261480|"~     Parvovirus B19 is a small virus that is the cause of fifth disease, a common infection in~     childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the~     bone marrow to stop producing red blood cells temporarily, which can be life-threatening. A~     novel vaccine is currently in development for children with SCD. This study is the first~     step within a larger parvovirus B19 multi-institutional project that will help develop this~     new vaccine, as it will define the value and utility of using a novel assay for measurement~     of parvovirus-specific antibodies. The main objective is to investigate the relationship~     between the newly developed VP1u ELISA assay and the gold standard neutralization assay for~     parvovirus B19 infection.~      The most accurate test, called a neutralizing antibody assay, to see if a person has had or~     currently has the infection is very complex and expensive and would be very difficult to use~     in a large research study to test the new vaccine. A new and simpler test has developed. The~     main goal of this study, iSCREEN, is to find out if this new test works.~      There will be distinct labs performing the VP1u ELISA and the neutralization assays and the~     respective laboratories will not have access to each other's results for individual~     subjects. The VP1u ELISA will be performed at St. Jude Children's Research Hospital.~     Neutralization assays will be conducted at the National Heart, Lung and Blood Institute.~   "
60795|NCT02261467|"~     This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and~     glabellar facial rhytides (frown lines).~   "
60796|NCT02261454|"~     Traditional postoperative care has been challenged recently to improve and speedup recovery~     (including the return of bowel function) such that patients can be discharged to home more~     quickly. This approach includes earlier mobilization of the patient, and introducing solid~     food sooner. Additionally, there is evidence in adults to suggest that sham feeding by~     chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet~     earlier.~      The aim of this study is to determine if gum chewing can enhance bowel recovery in children~     who undergo abdominal surgery.~   "
60797|NCT02261441|"~     IBERICAN is a multicenter, longitudinal and observational population-based study of patients~     daily attended in Primary Care setting in Spain.~      This study is aimed to determine the prevalence and incidence of cardiovascular risk factors~     in adult population in Spain.~      Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser~     period when clinically required.~      It has been estimated that a total of 15,000 individuals will be included.~   "
60798|NCT02261428|"~     The study compares the effectiveness of Tiemann and Suction catheters, with regard to~     attempts to enter the trachea and the time required for the procedure.~   "
60799|NCT02261415|"~     This is a multicentre Vanguard randomized controlled trial (RCT) to evaluate the impact of~     tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver~     resection. The rationale for this study includes: (1) experimental evidence supporting the~     use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver~     resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons,~     anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient~     study design; and (5) the importance of the question: incidence of blood transfusion in~     patients undergoing liver resection is high, and the consequences serious. Different regions~     of Canada are well represented in the selection of study sites and five major sites have~     committed to participate in the Vanguard trial: Sunnybrook Health Sciences Centre (Toronto),~     University Health Network (Toronto), Foothills Medical Centre (Calgary), McGill University~     Health Centre (Montreal), and Queen Elizabeth II Health Sciences Centre (Halifax). We will~     enroll 200 patients in this Vanguard study. This Vanguard study will assist us in~     determining the feasibility and planning of a definitive multicentre RCT across Canada. If~     the Vanguard study confirms feasibility, we will expand the trial to additional sites and~     proceed directly into the definitive trial (planned sample size = 1230 patients). The~     following is a brief schema and study outline of the trial.~   "
60923|NCT02259803|"~     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.~      mono-components of telmisartan and amlodipine~   "
60924|NCT02259790|"~     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.~      mono-components of telmisartan and amlodipine~   "
60800|NCT02261402|"~     Medisinstart is a new service developed for use in Norwegian pharmacies. It is intended~     for patients that are about to start a new medicine for a chronic or long-term condition. It~     is based on research showing that problems with newly prescribed medicines appear rapidly~     and that a significant portion of patients quickly becomes non-adherent. The service~     consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the~     second at 3-5 weeks after start of the new medicine.~      The main purpose of this study is to investigate whether Medisinstart increases patients'~     adherence to the prescribed medication. Patients' beliefs about their medicines and their~     motivation for adherence will also be examined. The study also aims at revealing if~     Medisinstart has additional benefits for the patient, the society and the pharmacies.~   "
60801|NCT02261389|"~     The main purpose of follow-up in asymptomatic breast cancer patients during and after~     adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of~     this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA~     and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a~     critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast~     cancer local and distant recurrence compared to the usual follow-up practice.~   "
60802|NCT02261376|"~     This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy~     subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65~     years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years.~   "
60803|NCT02261363|"~     The universe of tobacco products is expanding, with new noncombustible products gaining~     popularity even as the reduction in prevalence of cigarette smoking slows or stalls.~     E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of~     these emerging noncombustible products. With sales increasing rapidly and more efficient~     pulmonary delivery devices under development, ENDS are likely to play an increasing role in~     the future tobacco market. Little is known about the cognitions and behaviors leading to or~     sustaining ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce~     perceived smoking harms, or for smoking cessation. Evidence about ENDS use is emerging from~     national surveillance and laboratory research, but the majority of information on ENDS is~     limited to retrospective surveys and convenience samples of White male ENDS users. The~     investigators research suggests Black smokers are less likely than White smokers to try and~     be current ENDS users, perhaps due to a greater degree of perceived harm associated with~     ENDS, a preference for menthol, or cultural norms. Thus, it is timely and critical to study~     how all smokers, including Blacks and menthol smokers, experience and initiate ENDS use~     employing valid, innovative research methods.~   "
60804|NCT02261350|"~     To determine the feasibility of delivering different community nutritional interventions to~     chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of~     malnutrition following a hospitalisation for an acute exacerbation of COPD.~   "
60805|NCT02261337|"~     This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia~     predict mortality in patients with chronic respiratory disease.~   "
60806|NCT02261324|"~     This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing~     primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to~     assess whether this can predict future cardiovascular events and death.~   "
60807|NCT02261311|"~     The investigators will compare the differences in the scores between the baseline~     questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II~     patients that enrolled in pre-treatment trials versus those that don't.~   "
60808|NCT02261298|"~     The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and~     efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors~     who are refractory or intolerant to standard therapy or for whom no appropriate treatment is~     available.~   "
60809|NCT02261285|"~     The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered~     to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant~     to standard therapy or for whom no appropriate treatment is available.~   "
60810|NCT02261272|"~     The study will test an internet-based treatment for insomnia.~   "
60811|NCT02261259|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of head-neck motor control. In order to accomplish this goal, the~     investigators aim to quantify changes in head-neck motor control before and after~     osteopathic manipulative treatment. The investigators hypothesize that head-neck motor~     control will improve in neck pain participants after 4-weeks of treatment. Additionally, the~     investigators will compare position and force head-neck motor control between healthy~     controls and neck pain patients. The investigators hypothesize that baseline tests of~     position and force head-neck motor control will be better in healthy individuals than neck~     pain patients.~   "
60812|NCT02261246|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of trunk motor control. In order to accomplish this goal, the~     investigators aim to quantify changes in trunk motor control before and after spinal~     manipulation treatment. The investigators hypothesize that trunk motor control will improve~     in the low back pain participants after 4-weeks of spinal manipulation treatment.~     Additionally, the investigators will compare position and force trunk motor control between~     healthy controls and low back pain patients. The investigators hypothesize that baseline~     tests of position and force trunk motor control will be better in healthy individuals than~     low back pain patients.~   "
60827|NCT02261051|"~     Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is~     the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent~     Control Study). The primary aim of the study is to compare the proportion of advanced cancer~     patients who have a hospitalization or emergency department visit in the last 6 months of~     life before and after implementation of a new care model that provides more comprehensive~     symptom management and supportive care, including earlier referral to palliative care. The~     secondary comparative aim is to assess measures of quality of life and satisfaction in both~     groups. This current study is to collect data on the control group only. After system~     redesign, we will open an intervention arm study to collect data after implementation of the~     new care model (about 18-24 months from start of control phase).~   "
60813|NCT02261233|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of postural control of the trunk. In order to accomplish this goal,~     we aim to quantify balance performance in an unstable seated task. Specifically, the~     investigators will quantify balance performance in low back pain participants before and~     after osteopathic manipulative treatment. The investigators hypothesize that there will be a~     significant improvement in balance performance after a single session of osteopathic~     manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and~     this improvement will be greater than any learning effect.~      A secondary objective of this study is to quantify differences in patient-oriented outcome~     measures (e.g., self-reported pain, disability) in low back pain participants before and~     after osteopathic manipulative treatment. The investigators hypothesize that there will be a~     significant improvement in these self-reported outcomes following osteopathic manipulative~     treatment. The association between improvement in postural control parameters and~     patient-oriented measures will also be explored.~   "
60814|NCT02261220|"~     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the~     safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination~     with tremelimumab in subjects with select advanced solid tumors.~   "
60815|NCT02261207|"~     This is an investigator initiated, open label, prospective, non-randomized, phase II trial~     aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive~     advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally~     reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive~     advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice~     a day, continuously. Treatment will be continued till evidence of progression, or toxicities~     or patient withdrawal.~   "
60816|NCT02261194|"~     The purpose of this trial is to determine the short-term effect of a self-care intervention~     on depression in patients with age-related macular degeneration or diabetic retinopathy.~   "
60817|NCT02261181|"~     There is a strong need to study products with a preemptive role in radiation dermatitis~     development, with a trial design taking in account patient subjective evaluation and~     compliance.~      XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical~     gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and~     pruritus, induced by radiotherapy or other causes.~   "
60818|NCT02261168|"~     This study evaluates the existence of a day-night rhythm in skeletal muscle energy~     metabolism in healthy lean subjects. Subjects will stay at the research facility for 44~     hours with a standardized living protocol during which several measurements of skeletal~     muscle and whole body energy metabolism will be performed.~   "
60819|NCT02261155|"~     Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory~     testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic~     susceptibility will be assessed before QST.~      QST data before and during hypnosis will be compared. Observed sensory changes will be~     evaluated in relation to the assessed hypnotic susceptibility~   "
60820|NCT02261142|"~     Spasticity is a common consequence of injury to the central nervous system and can be a~     major problem in motor function and everyday activities. A method for treating spasticity~     that applies low-amplitude electrical stimulation through a garment with built-in~     electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in~     combination with individualized training and the stimulation is mainly given to antagonists~     of spastic muscles.~      The general objective of this study is to evaluate the efficacy of and costs associated with~     the Mollii® treatment of spasticity due to stroke or cerebral palsy.~      Primary objectives are;~        -  to study whether treatment with the Mollii® improves function and activity~        -  to evaluate the cost-effectiveness of the treatment, from both a health-care~          perspective and a societal perspective.~      Secondary objectives are;~        -  to study whether there are differences in treatment effect between the stroke and the~          Cerebral Palsy groups in a subgroup-analysis~        -  to assess compliance with treatment~        -  to report any adverse effects.~   "
60821|NCT02261129|"~     Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two~     tablets of the telmisartan 40 mg conventional tablet~   "
60822|NCT02261116|"~     Study to assess potential different properties of telmisartan, which due to its Vd, should~     result in stronger beneficial effects of AT1 blockade in tissues (e.g. aldosterone~     suppression and renin increase) plus stronger AT2 stimulation compared to candesartan~   "
60823|NCT02261103|"~     The objectives of the studies are:~        -  To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER~          fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to~          reveal any food effect leading to uncontrolled release~        -  To investigate the relative bioavailability of the ER-formulation of pramipexole in~          comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple~          dosing~        -  To demonstrate dose proportionality between the dose strengths of the pramipexole ER~          formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing~   "
60824|NCT02261090|"~     Study to compare the oral bioavailability of seven prototype slow-release formulations to~     immediate-release tablets~   "
60825|NCT02261077|"~     Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single~     rising dose and after multiple rising doses~   "
60826|NCT02261064|"~     Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose~     combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5~     mg) in the fed condition compared with those of the same fixed-dose combination in the~     fasting condition in healthy Japanese male volunteers.~   "
60828|NCT02261038|"~     Femoral component rotation in total knee arthroplasty (TKA) has been considered an important~     factor for outcome. However, measurement of femoral component rotation is difficult to~     perform.~      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),~     axial CT slices and 3D reconstructed CT images.~      It was the hypothesis that measurements on radiographs are comparable to measurement on CT~     images.~      Measurements of femoral TKA rotation will be measured three times by three different~     observers and inter- and intraobserver reliability is calculated. The absolute values of~     each measurement method is noted in degrees.~   "
60830|NCT02261012|"~     This study aims for a better understanding of the pathophysiological mechanisms of the~     complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory~     testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the~     analysis of the heart-rate variability in patients with CRPS and a control-group. We~     hypothesize decreased conditioned pain modulation, less effects of remote ischemic~     conditioning and an affection of the heart-rate variability in patients with CPRS.~   "
60831|NCT02260999|"~     In this study, the detection of the feigning weakness in grip strength is measured using~     different grip strength testing instruments. Patients with injury of the upper limb are~     compared to patients with injury of the lower limb as well as healthy controls.~   "
60832|NCT02260986|"~     The purpose is to demonstrate efficacy and long term safety of dupilumab in combination with~     topical corticosteroids in patients with moderate to severe AD.~   "
60833|NCT02260973|"~     This is a randomized, masked, placebo controlled study to assess the effect on visual~     acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract~     surgery.~   "
60834|NCT02260960|"~     The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye~     related symptoms as well as clinical markers associated with dry eye disease~     (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up~     time) when compared to administration of placebo.~   "
60835|NCT02260947|"~     This study will examine the activity of 2 different doses of PF-06273340 on a panel of~     evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male~     subjects~   "
60836|NCT02260934|"~     In this experimental study, researchers will try to find out if treatment of lupus nephritis~     with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab~     and CTX followed by treatment with belimumab is safe and if this drug combination can block~     the immune system attacks.~   "
60837|NCT02260921|"~     This purpose of this study is to evaluate the effectiveness and safety of the iovera° device~     for the temporary reduction of pain associated with knee osteoarthritis.~   "
60838|NCT02260908|"~     Victims of trauma with severe head injury who have bled into their brains are at high risk~     of developing blood clots in their legs. These blood clots can break off and travel through~     the bloodstream to the lungs, resulting in death. Blood thinners can be given to patients to~     prevent blood clots from developing but this can leave patients at risk for additional~     bleeding in the brain, causing further damage or death. The earlier blood thinners are~     started, the more effective they are at preventing blood clots. In addition, some patients~     with severe head injury who have bled into their brains will develop further bleeding even~     if they do not receive blood thinners. Even though a growing body of research has shown that~     the majority of bleeding in the brain stops within the first 24 hours after injury and that~     it is safe to start blood thinners as early as 24 hours after injury, doctors are still~     waiting longer than 4 days to start blood thinners in these patients over concerns of~     worsening bleeding. In Canada, almost half of the patients with severe head injury do not~     receive blood thinners until at least five days after injury. Delays in starting blood~     thinners appear to put patients at increased risk of developing blood clots, unnecessarily.~     This study will compare the benefits of starting low-molecular-weight heparin (LMWH), a type~     of blood thinner, early (36 to 48 hours after injury) versus the current practice (waiting~     until the 6th day after being injured) in preventing blood clots in patients who have bled~     into their brains after severe head injury. The investigators believe that starting LMWH~     earlier will be more effective in preventing blood clots without worsening any bleeding when~     compared to waiting to start blood thinners. This study is called OPTTICH (OPtimal timing of~     Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian~     investigator-initiated randomized control trial on blood clot prevention in trauma patients~     with severe head injury who have bled into their brains.~   "
60839|NCT02260895|"~     Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an~     important goal. The progression from impaired glucose tolerance to diabetes is thought to be~     promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main~     defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is~     reduced first phase (immediate) insulin release. The investigators hypothesis is that~     consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes~     before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent~     carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and~     synthesis.~      The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour~     oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose~     tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of~     dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak~     of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with~     the timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).~      The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40~     mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour~     glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to~     show a statistically significant difference between the almond pre-test snack and control~     standard OGTT conditions.~   "
60840|NCT02260882|"~     The purpose of this study is to determine if revaccination with pneumococcal vaccine~     (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese~     adults. The primary hypothesis being tested is that the geometric mean concentration of~     antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after~     revaccination will be superior to that before revaccination in Japanese adults who received~     a primary vaccination at least 5 years before revaccination.~   "
60841|NCT02260869|"~     This is a single center randomized controlled trial. Approximately 102 patients will be~     randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar~     radiofrequency ablation. Patients with chronic knee pain, with moderate to severe~     osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have~     failed conservative therapy will be screened for the study.~      Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic~     guided single diagnostic block of the geniculate nerves (superior medial, superior lateral,~     and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).~      Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1,~     4, 12, 24 and 52 weeks.~      Outcome measures will be: Visual analogue scale (VAS) both while at rest and during~     ambulation, Oxford knee scores, WOMAC, and global perceived effect.~   "
60863|NCT02260583|"~     Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal~     phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2,~     long-term noninvasive mechanical ventilation (NIV) has been proposed.~      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is~     not always well tolerated and therefore it may be effective only in a subset of patients The~     aim of this study is to assess the feasibility and safety of one shot extrcorporeal CO2~     removal device, in reducing the PaCO2 level~   "
60842|NCT02260856|"~     This is a randomized controlled trial of epiphysiodesis techniques: percutaneous~     transphyseal screw epiphysiodesis versus percutaneous drill epiphysiodesis for the~     correction of leg length discrepancy. The primary outcome will be mean physeal growth~     following epiphysiodesis, at 6 months. Secondary outcomes will include fluoroscopy and~     surgical times, physeal growth at additional time points out to 2 years, pain, knee~     function, return to activity, quality of life, complications, need for additional surgical~     procedures and cost. A cost-effectiveness analysis will follow completion of the RCT. The~     authors hypothesize that mean growth at the treated physis will be significantly lower~     following drill epiphysiodesis compared to screw epiphysiodesis, measured at 6 months and~     that screw epiphysiodesis will have a shorter length of hospital stay, shorter fluoroscopy~     and OR times, fewer days with modified weight bearing, less time to full weight bearing,~     less pain, less time to return to sports, and higher quality of life, and higher knee~     function than drill epiphysiodesis. Additionally, the authors hypothesize that screw~     epiphysiodesis will be more expensive due to secondary surgeries to remove implants but that~     screw epiphysiodesis will be preferred by patients due to less pain, better outcomes,~     shorter time in hospital, and fewer days with modified weight-bearing.The results of this~     study are expected to improve outcomes for children undergoing epiphysiodesis.~   "
60843|NCT02260843|"~     Elderly insomnia is a serious public health problem. Current conventional approaches for~     treating insomnia are not suitable or effective in elderly population. It has been~     previously demonstrated that Tai Chi has definite advantages to be developed as self-help~     therapy in older adults and has been preliminarily demonstrated to improve sleep in older~     people. This project aims to evaluate the efficacy of Tai Chi training on alleviating~     chronic insomnia in older adults.~   "
60844|NCT02260830|"~     The purpose of this study is to investigate the pharmacokinetic (PK) properties of various~     modified release tablet formulations of Lu AF11167 (Part A) and to investigate the~     pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a~     fed and fasted state and following multiple dosing (Part B).~   "
60845|NCT02260817|"~     This Phase 3 study will target approximately 100 men over age 18 who have a biochemical~     relapse or other evidence of relapse of prostate cancer after primary treatment.~      The purpose of this study is to:~      A. Provide expanded access the drug 11C-choline.~      B. Determine the performance characteristics (sensitivity, specificity, positive predictive~     value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and~     PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in~     patients with biochemical relapse of prostate cancer after primary treatment in a~     prospective manner.~      C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT~     and PET/MRI positive patients through a prospective study.~      D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using~     a multivariable analysis of clinical and pathologic data collected prospectively.~      E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline~     PET/MRI and the combination of 11C-choline PET/CT and PET/MRI~      Study Protocol:~        1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.~        2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.~        3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic~          prostate cancer.~        4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed~          with biopsy or surgical pathology when possible, or by response to treatment on~          subsequent imaging.~        5. Rates of confirmed metastasis between conventional CT and MRI images will be compared~          with the 11C-choline PET CT and MRI images.~        6. Upon conclusion of each imaging protocol, the referring physician will receive written~          documentation of the results. At this time, the patient will be considered off study~          and no further follow up is required.~   "
60846|NCT02260804|"~     To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by~     overall response rate at 7 months~   "
60847|NCT02260791|"~     The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison~     to Humira® in rheumatoid arthritis patients who have inadequate disease control on~     methotrexate.~   "
60848|NCT02260778|"~     The purpose of this study is to determine if a Learning Collaborative is an effective tool~     to improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S.~     rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has~     been embraced by the American College of Rheumatology through the RA Treatment Guidelines~     and by EULAR,however several lines of evidence suggest that TTT is not practiced~     consistently across rheumatology settings.Participating practices will be randomized to~     receive the Learning Collaborative intervention in one of two phases. Coaching consistent~     with Learning Collaborative practices will be used to promote adherence to TTT. Chart~     abstraction will be used to determine if the Learning Collaborative was an effective tool to~     increase TTT adherence.~   "
60849|NCT02260765|"~     The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the~     different in resource utilization of treating depression with Deep TMS compare to the TAU.~      The current study is a prospective semi-naturalistic, randomized study in which depressed~     patient who failed to respond to at least one medication or could not tolerate at least two~     antidepressants and are seeking for alternative treatment will be offered to join an open~     label study. The study designed as double arm study of which patient will have 50% chance to~     be randomized to one of the study groups.~      The study includes two arms. The dTMS study group will be treated according to the cleared~     FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of~     biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated~     by their primary care physician / psychiatrist according to the usual treatment recommend to~     the patient clinical status~   "
60850|NCT02260752|"~     The overall goal of this project is to better enable patients with uterine fibroids (UF) to~     make informed decisions about treatment options by leveraging the highest possible evidence~     of healthcare quality. The foundation of this project will be a multi-site, prospective~     registry of a diverse group of women who have undergone either medical or surgical treatment~     for UF.~      Specifically, the investigators are interested in: comparing management options for symptom~     relief; comparing management options for preserving reproductive function; and comparing~     effectiveness among different subpopulations, including consideration of patient needs and~     preferences of treatment options.~   "
60864|NCT02260570|"~     The ability to regulate impulses enables us to plan for the future, to maintain focus in the~     face of distractions (i.e. to encode memories), and to manage emotions. This self regulation~     can be compromised in individuals who have a history of mild traumatic brain injury and~     co-occurring disorders. In this study the investigators are using functional MRI scanning to~     understand how memory and self regulation are expressed in the brains of people with a~     history of mild traumatic brain injury. The investigators are also testing whether the~     medication tolcapone may improve memory and self regulation.~   "
60865|NCT02260557|"~     The primary objective of the study is to determine the activity of selexipag on Raynaud~     attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis~     (SSc).~   "
60851|NCT02260739|"~     Recent advances in hematology clearly illustrate that the simple clonal nature of various~     hematological malignancies may not really reflect the reality of malignant cells natural~     expansion. This has been nicely illustrated in recent works in AML for example where~     subclones coexists in the same patient at the same time, but could also differentially~     expand over time because of effects of therapeutics intervention, but also by oncogenic~     spontaneous events (1).~      These observations have been done recently because of next generation sequencing that allows~     to discriminate in the same tumor samples, different subclones and to analyse the clonal~     architecture. Sequential analyses could help us to identify the first oncogenic event and to~     correlate disease progression to the emergence of subclones.~      For all these reasons it is of a major interest to precisely understand the architecture of~     the clone in MPNs, especially to understand which is the initiating event and how from this~     initial event the clone develops.~      In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be~     extremely effective. If JAK2V617F is a secondary event its targeting might allow to~     alleviate the MPN, but may favor the development of other malignant hemopathies.~   "
60852|NCT02260726|"~     Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to~     deformities in the hip joint. However some individuals have these deformities but do not~     exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not~     clear which deformities will cause degeneration, requiring surgical intervention. We propose~     to evaluate the deformity and impingement between the femur and acetabulum using dynamic~     ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip~     joint and is thus suitable for such diagnostic purposes. In this pilot study we will~     evaluate the feasibility of ultrasound in diagnosing hip impingement.~   "
60853|NCT02260713|"~     Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and~     feasibility of autologous bone marrow cell transplantation in case of acute complete spinal~     cord injury by each of the following techniques and a corresponding number of controlled~     subjects:~        -  Directly into the injured site with a syringe after exposing the spinal cord.~        -  By Intrathecal injection.~   "
60854|NCT02260700|"~     The purpose of this study is to determine pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and the relative-bioavailability (the~     extent to which a drug or other substance becomes available to the body) of JNJ-54861911~     solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy~     older male participants.~   "
60855|NCT02260687|"~     The objectives of this study are to investigate the safety and effectiveness of EYLEA.~   "
60856|NCT02260674|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     JNJ-54861911 during 6 months of treatment in participants with early (predementia)~     alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious~     onset of dementia, impairment of memory, judgment, attention span, and problem solving~     skills are followed by severe apraxias and a global loss of cognitive abilities]).~   "
60857|NCT02260661|"~     First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is~     administered as a single agent in a multiple ascending dose escalation phase to investigate~     dose level for monotherapy. Part B follows the multiple ascending dose phase, additional~     patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose~     expansion phase. Part C is a second dose escalation phase in which post-menopausal patients~     with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in~     combination with fulvestrant. Part D follows the combination dose escalation phase of the~     study, additional postmenopausal patients with ER+/HER2 negative breast cancer with~     documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination~     dose-expansion phase at maximum tolerated dose or recommended phase II dose.~   "
60858|NCT02260648|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as evacetrapib when administered in combination with atorvastatin for 12 weeks in~     Japanese participants with primary hypercholesterolemia.~   "
60859|NCT02260635|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double~     blind treatment period will last for 12 weeks and the open-label extension period will last~     for an additional 40 weeks.~   "
60860|NCT02260622|"~     Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop~     critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.~     CLI results in resting pain, ulcers, gangrene, and limb loss. The outcome for patients with~     CLI is poor. Within 3 months of onset, 12% of patients will require an amputation (removal~     of part of the limb) and 9% will die of major cardiovascular events (heart attack or~     stroke). Percutaneous angioplasty (PTA), a procedure used to open the blockages in blood~     flow, has become the first-line treatment for CLI given its effectiveness, lower cost, and~     lower risk of complications. However, 40% of patients will have re-narrowing of the arteries~     (restenosis) following the PTA procedure. This is thought to happen in part due to build up~     of blood cells called platelets which can also lead to the formation of blood clots. In~     order to try to avoid this problem, most patients are prescribed a combination of two blood~     thinning medications, acetylsalicylic acid (ASA or aspirin) and clopidogrel (the brand name~     is Plavix).~      The purpose of this study is to determine if a new blood thinner called rivaroxaban, given~     in combination with aspirin, would be more effective in preventing re-narrowing of the~     arteries than the current standard of care (aspirin and clopidogrel).~      Rivaroxaban is a pill and does not require blood test monitoring. It has been approved by~     Health Canada for use in prevention of blood clots in patients undergoing hip or knee~     surgery and to treat patients with blood clots in their legs and lungs. Low dose aspirin has~     been approved for reducing the risk of heart attacks and strokes. These medications have not~     been tested together in patients for prevention of re-narrowing of their arteries~      This is a pilot study conducted at one center, The Ottawa Hospital.~      It is a Phase 2 open label randomized controlled trial.~      Following the PTA procedure, once all inclusion/exclusion criteria are met, the participant~     will be randomized into one of two groups:~        1. Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily OR~        2. Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~      Visits will occur at 7 days, 30 days, 90 days, 6 months and 12 months. Participants will be~     followed for 12 months (± 14 days) in total. All adverse events will be collected for the~     duration of the study.~   "
60861|NCT02260609|"~     A multicenter, open-label, single-arm study to evaluate the safety and efficacy of~     GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or~     bone.~   "
60862|NCT02260596|"~     A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell~     transplant (HSCT) recipients will be assembled to determine the incidence of respiratory~     viral infections diagnosed during an inpatient admission in the first year post-transplant.~     A sub-cohort of patients that develop a respiratory viral infection within one year of~     transplantation will be leveraged to investigate factors associated with mortality in the~     three months after respiratory viral infection.~   "
60869|NCT02260505|"~     This is a 2 arms study concerning patients with primary GIST who followed an Imatinib~     adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.~      In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to~     determine if the continuation of this treatment is efficient for disease control, in terms~     of Disease Free Survival improvement.~      In the second arm, patients will discontinue the Imatinib treatment, as standard practice.~     This arm will allow to determine if the re-introduction of Imatinib at relapse is still an~     efficient treatment for the control of disease.~   "
60870|NCT02260492|"~     This is a study to establish the equivalence of OT329 Solis and Advair Diskus when~     administered by inhalation in patients with asthma.~   "
60871|NCT02260479|"~     The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in~     alcohol was non-inferior compared to room-temperature regarding skin colonization as well as~     bacterial colonization in wound, skin temperature and patients experiences.~   "
60872|NCT02260466|"~     Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS)~     markedly increases with age. Aortic stenosis increases left ventricular pressure overload.~     Cardiac deposits have been observed in AS and the amount of these deposits has been~     correlated to post-surgical outcome. As they are strong echocardiographic and cardiac MRI~     imaging similarities between CA and AS, the investigators hypothesized that the deposit~     observed in AS is transthyretin amyloid deposit. The investigators objective is to~     demonstrate that amyloid deposit is associated with poor outcomes following aortic stenosis~     surgical valve replacement.~      Materiel and methods: 180 patients with indication for surgical aortic valve replacement~     will be recruited prospectively and consecutively in 5 French centers. A replicative study~     will be performed in one Austrian center. Echocardiography, cardiac MRI and bone~     scintigraphy will be performed prior to surgery. During surgery, a basal LV septum biopsy~     will be collected for determination and quantification of interstitial deposits using~     specific staining which will be performed in a blind fashion. Clinical outcomes will be~     recorded during the hospitalization period following the surgery and at 1 year. Alive and~     re-hospitalization status will be determined. Patients will be classified according to the~     presence or not of amyloid deposits.~      Expected results and impact: This study will emphasize how pressure overload stress~     accelerates and magnifies amyloid deposition usually known to be related to cardiac aging~     process. It will develop reliable imaging tools and markers to detect cardiac amyloid~     deposition. Correlation between anatomopathologic analyses and the three different imaging~     technics will identify accurate imaging markers of CA. A risk stratification model based on~     amyloid deposits level for the clinical management of these patients will be created~     combining imaging and biological markers.~   "
60873|NCT02260453|"~     The purpose of this study is to evaluate the potential benefit of systematic preoperative~     coronary angiography followed by selective coronary artery revascularization on the~     incidence of myocardial infarction (MI) in patients without a history of coronary artery~     disease (CAD) and undergoing carotid endarterectomy (CEA).~   "
60874|NCT02260440|"~     This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity,~     safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with~     chemo-refractory mCRC without any further standard treatment options~      Dosage and regimen for all study periods~        -  Pembrolizumab will be given at 200 mg every 21 days.~        -  Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21~          days.~      The first assessment of tumor response will be performed after cycle 3 (9 weeks), and~     thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1~     will be used to establish disease response or progression.~      All patients will be evaluated and graded for adverse events according to the NCI Common~     Terminology for Adverse Events, version 4.0 (NCI-CTCAE).~   "
60875|NCT02260427|"~     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these~     devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating~     laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new~     single-use device that may optimise the airway sealing while reducing the potential for~     postoperative complications such as sore throat. The overall structure of the air-Q sp is~     similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial~     was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients~   "
60876|NCT02260414|"~     In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients~     with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or~     erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in~     myeloma seems no more effective than that achieved with aspirin, while the effectiveness of~     the latter in the primary prevention of VTE has never been demonstrated regardless of the~     type of population considered. Meanwhile, a biological study showed that prophylactic doses~     of LMWH in patients with different types of cancer did not always optimal reduction of~     thrombin peak during the 24 hours following the injection of LMWH. These clinical and~     biological studies lead to the conclusion that patients with myeloma may be resistant to the~     usual doses of preventive LMWH, which may explain the failure of prevention.~      Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is~     present in patient's biology and if this resistance is specific to myeloma in hematological~     cancers. For this, we propose to study the evolution of thrombin generation by~     Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin~     in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with~     thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not~     accumulate in patients with impaired renal function, and has a greater anti-biological~     activity thrombotic than other LMWH.~      To assess whether the observed pattern of thrombin generation is particularly multiple~     myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical~     patients hospitalized for acute heart and respiratory failure.~   "
60877|NCT02260401|"~     Spinal stenosis is one of the most common causes of low back pain among older adults and can~     result in significant disability. Despite this, it still isn't known which treatments are~     most effective or what outcomes are most important to these older adults. Through a Patient~     Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the~     existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness~     research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS~     trial) to address several critical research questions. The proposed study will answer the~     following key questions. Do decision aids tailored to older adults with spinal stenosis~     change patient decision-making regarding subsequent treatments? Do patients respond~     differently at subsequent outcome assessments time-points after receiving tailored decision~     aids that contain their own individual outcome data from prior treatments? The investigators~     hypothesize that providing these individualized reports will allow patients to make more~     informed choices regarding subsequent treatments, leading to reduced use of ineffective~     treatments and improved outcomes overall.~   "
60879|NCT02260375|"~     The general aim of the present study is to test a cell therapy with third-party allogeneic~     ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs~     will be prepared accordingly to established protocols , starting from diagnostic samples of~     bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the~     bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities~     and used for the present study in patients undergoing liver transplantation.~   "
60880|NCT02260362|"~     The complex congenital cardiac malformations are a significant number of different diseases,~     each having specific natural histories. The interface with pulmonary arterial hypertension~     (HTAP) is high since the physiology of many of these disorders comprises alterations in~     pulmonary vasculature.~      This observatory is a cohort of 400 patients enrolled in 3 years, older than one month,~     having been informed and have agreed to participate in the study and with congenital heart~     disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension~     confirmed by cardiac catheterization.~      The main objectives of this report are to know~        -  Incidence of congenital heart disease in HTAP France.~        -  Describe the natural history of HTAP in a large population of patients Congenital heart~          disease in France~        -  The characteristics of HTAP congenital heart disease~        -  Having a cohort study~   "
60881|NCT02260349|"~     Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a~     major public health problem. Until 28% of patients treated with surgery will present a~     positive surgical margin resulting in an incomplete clearance of the tumoral process and~     exposing so the patient at a local, systemic recurrence and increased morbidity. An~     increasing number of international publications have shown (ICG) was interesting for the~     detection of the sentinel lymph node, in the surgery of tumors of type hepatocarcinoma and~     liver metastases from colorectal diseases, but also in the surgery of the kidney, bladder or~     breast. ICG has affinity for tumor and tissues around the tumor related to micro-vascular~     histology for a localized and specific deposit (EPR effect).~      The detection of ICG 's deposits is now possible with to the use of a device which allow to~     visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm.~     Thanks to this feature, the location of residual tumor tissue when performing a radical~     prostatectomy could be made much easier.~   "
60882|NCT02260336|"~     The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on~     Rheumatic Pain.~   "
60883|NCT02260323|"~     To evaluate the compliance of traditional Chinese medicine (TCM) in young people with~     Chronic rheumatic disease~   "
60884|NCT02260310|"~     The purpose of this study is to evaluate the effect of acupuncture protocol involving in~     Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.~   "
60885|NCT02260297|"~     70 overweight or obese adults with sleep disorders will be recruited for this study, in~     which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep~     monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters~     derived from this actigraphy.~   "
60886|NCT02260284|"~     The purpose of this study is to evaluate the efficiency and safety of Acupotome in Treating~     Ankylosing Spondylitis.~   "
60887|NCT02260271|"~     Create a database with selected medical information on infants born with hypoxic-ischemic~     encephalopathy (HIE). In addition, the following samples will be collected in a~     bio-repository for future studies: blood, urine, and buccal samples.~   "
60888|NCT02260258|"~     The main purpose of this study is to evaluate if neuromuscular blockade improves lactate~     clearance (and preliminary secondary clinical outcome measures) as compared to usual care in~     post-cardiac arrest patients undergoing targeted temperature management.~   "
60889|NCT02260245|"~     TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is an~     evidence-based teamwork system designed to improve communication and teamwork skills among~     health professionals. The program was developed by the Agency for Healthcare Research and~     Quality (AHRQ) and the Department of Defense's Patient Safety Program as the national~     standard for team training in health care.~      The purpose of this study is to evaluate the effect of the TeamSTEPPS program on the team~     knowledge, skills and attitudes and patient safety at Planned Parenthood affiliates~     nationwide.~      The investigators hypothesize that implementation of the TeamSTEPPS program will be~     associated with improved team knowledge, skills, and attitudes; clinical outcomes; and~     process outcomes.~      Aims:~        1. To assess the effect of the TeamSTEPPS training program on team communication and~          effective team work~        2. To assess the effect of the TeamSTEPPS training program on process outcomes~        3. To assess the effect of the TeamSTEPPS training program on clinical outcomes~   "
60890|NCT02260232|"~     Objective: To investigate the effects of a one-year worksite individual exercise~     intervention on lifestyle-related modifiable health risks, physical capacity and work~     performance.~      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104~     men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical~     activity levels were assessed by the long self-administrated version of the International~     Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal~     cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures~     were collected from participants at baseline survey, at 6 months and 1-year after.~     Components of the program included supervised moderate to high intensity cardiorespiratory~     exercise, resistance training, and flexibility.~   "
60891|NCT02260219|"~     Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage~     Device, model M4 compared with the model S2.~      Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group~     (M4 and S2). They will be operated using conventional techniques and creating a~     sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be~     monitoring for one year and the results will be evaluated with respect to a postoperative~     reduction in pressure, changes in visual acuity, the need for drugs and complications, in~     addition to the demographic characteristics of each group.~   "
60892|NCT02260206|"~     The effects colchicine administration for acute pericardial effusion after radiofrequency~     catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.~   "
60893|NCT02260193|"~     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in subjects with end stage renal disease~     undergoing chronic hemodialysis.~   "
60899|NCT02260115|"~     The purpose of this study is to obtain data on the safety and manageability of applying~     LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following~     laparoscopic gynaecologic surgery. In addition, performance data following a clinical~     indicated second look laparoscopy will be collected for the purpose of determining sample~     size predictions for future trials.~   "
60900|NCT02260102|"~     Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance~     to most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing~     antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce~     extended-spectrum beta-lactamases. Little is known about dosing and elimination of~     temocillin in children. While available literature of temocillin use in paediatrics refers~     mainly to its clinical efficacy in the treatment of urinary tract infections, the drug is~     also used for the treatment of suspicion of cholangitis in cirrhotic paediatric patients,~     and as antibiotic prophylaxis following an hepatic transplant in children (both off-label~     indications). There is, therefore, a pressing need to explore the pharmacokinetics and~     pharmacodynamics of temocillin in the paediatric population, in order to provide clear~     guidance on an appropriate dosing regimen. The study objectives are: (1) characterisation of~     the pharmacokinetics (PK) of temocillin in 3 paediatric populations, (2) proposal and~     development of a dosing schedule that can ensure therapeutic concentrations (40% ƒT > MIC)~     and optimize treatment chances of success, and (3) characterization of MICs of~     microbiological strains (when available) to temocillin.~   "
60901|NCT02260089|"~     To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with~     mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with~     ABPM~   "
60902|NCT02260076|"~     To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses~   "
60903|NCT02260063|"~     To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup~     and 20 mg tablets~   "
60904|NCT02260050|"~     To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the~     conventional formulation of WAL 801 CL dry syrup~   "
60905|NCT02260037|"~     Safety, tolerability and pharmacokinetics~   "
60906|NCT02260024|"~     The primary objective of the study was to estimate the magnitude of the error in the~     prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data~     applying the methods of IVIVC. The secondary objective of the study was to investigate~     whether the intake of food 30 minutes prior to drug administration affects the systemic~     exposure of pramipexole SR C2 or not~   "
60907|NCT02260011|"~     The objective of this study was to compare the bronchodilator efficacy and safety of~     ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation~     Aerosol in COPD patients~   "
60908|NCT02259998|"~     To investigate the relative bioavailability of the proposed formulation of PERSANTIN®~     compared to the present commercial formulation.~   "
60909|NCT02259985|"~     food interaction, pharmacokinetics, safety and tolerability~   "
60910|NCT02259972|"~     To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of~     BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.~     fed (food effect for the tablet).~   "
60911|NCT02259959|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and~     Tiotropium Bromide when given as fixed dose combination~   "
60912|NCT02259946|"~     Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg,~     20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for~     doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744~     CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the~     pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their~     dose proportionality, and to explore the pharmacodynamic effects of the treatments on~     selected metabolic and respiratory parameters~   "
60913|NCT02259933|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated~     dosing~   "
60914|NCT02259920|"~     Study to determine and compare the absorption of KUC 7483 CL from different regions of the~     GI tract with the immediate release formulation and to compare the absorption of particulate~     versus solution formulations from the ascending colon~   "
60915|NCT02259907|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483~   "
60916|NCT02259894|"~     To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in~     single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution~     in healthy subjects~   "
60917|NCT02259881|"~     To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on~     parameters of coagulation, platelet activation and inflammation in a model of tissue factor~     triggered activation of the coagulation system; to examine the safety of BIBT 986 in this~     setting~   "
60918|NCT02259868|"~     1. To investigate the relative bioavailability (BA) of improved tablet formulation~          candidates to determine which formulation will be developed for use in late Phase II~          and Phase III clinical trials~        2. To investigate the relative BA of the pediatric suspension, compared to the current 1B~          formulation~        3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three~          25mg tablets vs. one 75 mg tablet, current 1B formulation~   "
60919|NCT02259855|"~     The primary objectives were:~        -  To determine the effects of steady state TPV co-administered with low dose RTV on~          steady state PegIFN and RBV in HIV negative subjects with mild hepatic impairment~          (scheme A)~        -  To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on~          steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative~          subjects with mild hepatic impairment (scheme A)~        -  To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in~          subjects with moderate hepatic insufficiency (scheme B)~   "
60920|NCT02259842|"~     Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in~     healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of~     food effect by re-dosing at 50 mg and 150 mg~   "
60921|NCT02259829|"~     Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose~     combination vs. its monocomponents~   "
60930|NCT02259712|"~     Introduction: Hipopressive Exercises are included within a method of physiotherapy which was~     created with the purpose of strengthening the deep muscles of the abdomen without damaging~     ligamentous and muscular structures of the perineum, also strengthening the muscles of~     pelvic floor reflexively. Although this technique has been included as treatment and a~     prevention method of pelvic floor dysfunction, there are few studies supporting its~     benefits. The investigators hypotthesis is that the combination of both physical therapy~     treatments will provided the best results for women who suffer pelvic floor dysfunctions.~      Objective: To determine whether Hipopressive Exercises are an option to include in the~     physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether~     the results reported are comparable to those provided by the classical perineal~     physiotherapy.~      Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the~     intervention group to which subjects were assigned. Participants will be randomly assigned~     to three groups:~        1. An experimental group, where the participants will be treated by Hipopressive exercises~          and hygienic and behavioral measures;~        2. Another experimental group where classical perineal physiotherapy will join with~          Hipopressive exercises and hygienic and behavioral advises;~        3. And a third group where will be done classical perineal physiotherapy and hygienic and~          behavioral measures.~      Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made.~     The selection criteria will be: adult women who present signs and symptoms that indicate a~     pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must~     understand and sign freely Informed Consent.~      Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast,~     26 subjects were required in each group to detect a difference equal to or greater than 3~     microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the~     rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).~      Data Analysis: A descriptive analysis of all variables was performed. It establish for all~     cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the~     experienced change of the three goups in outcome variables between physicaltherapy~     examinations.~   "
60931|NCT02259699|"~     The objective of this study is to develop and test a new decision aid -named Patient~     Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify~     trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and~     survival, based on their own preferences and personal clinical characteristics, described in~     terms that are meaningful to them. To accomplish this, the investigators will 1)develop the~     PCOA, a patient- and provider-friendly decision aid and 2)test the effectiveness of PCOA~     through a randomized controlled trial (RCT).~      The investigators hypothesize that PCOA will be significantly better than usual care,~     resulting in patients reporting more satisfaction with their treatment decision, less~     decision regret, better quality of life, and more satisfaction with their care compared with~     similar patients not having access to PCOA. If these hypotheses are substantiated, patients~     and providers will have an improved model for communication and decision making, leading to~     better patient outcomes.~   "
60932|NCT02259686|"~     Apelin is an endogenous peptide with physiological actions in the cardiovascular system.~     Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of~     clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation~     and increased cardiac contractility. We wish to study and compare the cardiovascular effects~     of subcutaneous versus intravenous apelin. We specifically wish to determine how different~     methods of apelin administration affect cardiac output and peripheral vascular resistance in~     healthy volunteers~   "
60933|NCT02259673|"~     In this research, the elderly living in nursing homes were selected in two group control and~     intervention.~      Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises~     (including activities carried out with the use of sports equipment such as beach ball,~     stretch, bird toys, etc).~   "
60934|NCT02259660|"~     The purpose of this research study is to determine if muscle training will improve snoring~     and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity~     of their apnea. After this study, subjects will be randomly assigned to one of two groups.~     The first group will receiving a breathing trainer that may strengthen the muscles used to~     breath in and out. The second group will be receive a sham trainer which looks like the~     real trainer but is not able to produce a strengthening effect. Both groups will complete~     eight weeks of home based (real or sham) training. The sleep study will be repeated and we~     well measure any changes in measures of severity for obstructive sleep apnea.~   "
60935|NCT02259647|"~     60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient~     will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and~     control group will receive Sorafenib plus placebo~   "
60936|NCT02259634|"~     This is a 3-year prospective randomized comparative study of the efficacy of patient~     navigation on health education, health related quality of life, healthcare utilization, and~     medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the~     patient-navigator intervention or to a care-as-usual control condition. A total of 300~     recently incarcerated individuals will be enrolled with 150 subjects each in the~     intervention and usual care group.~      The investigators hypothesize that the intervention will improve health education, health~     related quality of life, adherence to clinical appointments, glycemic/blood pressure~     control, and virologic suppression in HIV-infected. The results of this study will~     demonstrate interventions to eliminate health disparities in a highly marginalized group~     going through the transitional phase of re-entry into the community.~   "
60937|NCT02259621|"~     Anti-PD-1 (nivolumab) administration in the pre-operative setting will be safe and feasible~     in patients with resectable NSCLC.~      Anti-PD-1 (nivolumab) administration will change cellular and molecular characteristics of~     the tumor microenvironment that can be quantitatively measured.~      Failure to respond to anti-PD-1 in NSCLC results from either pre-existing or compensatory~     (i.e. adaptive) up-regulation of additional immune checkpoint pathways in the tumor,~     draining lymph nodes, and/or peripheral blood that inhibit immune recognition and killing of~     tumor cells. Characterization of these pathways (i.e. ligands and receptors) in patients~     receiving preoperative anti-PD-1, and comparison with a cohort of patients who proceed to~     surgical resection without preoperative anti-PD-1, will illuminate mechanisms of adaptation~     and immune resistance to directly guide future therapeutic development of anti-PD-1 as~     monotherapy and in combination with other immunomodulators in NSCLC.~   "
60968|NCT02259218|"~     This research trial studies metabolomic and other molecular profiling to identify predictive~     biomarkers for radiation toxicity and survival in patients with lung or brain cancers~     receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with~     lung or brain cancer in the laboratory may help doctors identify and learn more about~     biomarkers related to cancer and predict which patients are at higher risk for developing~     radiation side effects and how well patients will respond to radiation treatment.~   "
61250|NCT02255474|"~     This study will evaluate the use of two different bifocal contact lens add powers to prevent~     further nearsighted progression in children ages 7 to 11 years old. It is theorized that the~     profile of the bifocal lenses will decrease the amount of change in nearsightedness that the~     children experience.~   "
60938|NCT02259608|"~     Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against~     extrapulmonary infection with Mycobacterium tuberculosis and leprosy. It has been shown that~     vaccination with BCG also leads to nonspecific protective effects, e.g. reduced infant~     mortality as a result of less severe infections, stimulation of the immune system in~     patients with bladder cancer and higher cytokine production upon restimulation of~     macrophages with non-related infectious pathogens in vitro. However, because the live~     attenuated BCG vaccine cannot be used in immune compromised hosts, the investigators would~     like to determine whether similar protective non-specific effects can be induced by~     γ-irradiated BCG.~      Objective: To determine whether vaccination with γ-irradiated BCG results in a higher~     cytokine response by monocytes upon restimulation in vitro with infectious pathogens,~     compared to monocytes before the vaccination.~      Study design: Explorative intervention trial. Study population: Healthy volunteers, 18 - 55~     years old. Intervention: Healthy volunteers will be vaccinated with γ-irradiated BCG~     vaccine.~      Main study parameters/endpoints: Blood will be drawn before and at two different time points~     after vaccination with BCG to perform restimulation of isolated cells in vitro and compare~     cytokine production.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There is no known direct benefit for the volunteers to participate in the~     trial. The risks are negligible. BCG vaccination can cause pain and scarring at the site of~     injection, just as fever and headache. Local hematoma formation can occur at the site of the~     blood drawing. This will be minimized by the blood collection by experienced persons.~   "
60939|NCT02259595|"~     This study is a single-center, randomized, placebo-controlled, double-blind, single~     ascending dose escalation study to determine the safety, tolerability, and PK profile of~     oral administration of HPN-07 in single doses to approximately 32 healthy male and female~     subjects between 18 and 55 years of age.~      Subjects will receive single oral doses of the study drug. The primary endpoint of this~     trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine~     (NAC).~   "
60940|NCT02259582|"~     A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV~     non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given~     in combination with carboplatin and pemetrexed compared to placebo. The administration of~     carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small~     cell lung cancer.~   "
60941|NCT02259569|"~     The purpose of this study is to compare peak airway pressure and gastric insufflation in~     Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric~     patient~   "
60942|NCT02259556|"~     Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of~     tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be~     treated by CD30-specific CART cells (CART30).~   "
60943|NCT02259543|"~     The aim of this study is to investigate the effects of the application of a citric acid +~     tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the~     outcomes of treatment of Miller's class I or II recession defects by subepithelial~     connective tissue graft.~   "
60944|NCT02259530|"~     The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and~     comorbid khat dependence. In this case series, evidence-based techniques will be applied and~     adapted to the cultural background of Somali refugees in Kenya.~   "
60945|NCT02259517|"~     Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two~     types of medications with differing mechanisms of action: stimulants and non-stimulants. The~     stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release~     guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that~     both medications are effective in reducing ADHD symptoms, although the neurobiological~     mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of~     this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients~     with ADHD. MRI scanning will be used to identify treatment-related changes in brain~     structure and function.~   "
60946|NCT02259504|"~     This is a prospective, single-arm, multi-center post-marketing Study. The Study will~     commence as a single phase, with an optional second phase to follow at the discretion of the~     sponsor. Up to 300 eligible Subjects with small (< 4.9 mm) intracranial aneurysms, who~     consent to Study participation, will be treated in Phase 1 with Microvention HyperSoft® 3D~     and HyperSoft® helical coils with or without balloon remodeling or stent assistance at the~     discretion of the treating physician. The operator, at his/her discretion, may choose to~     frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the~     remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils. Upon approval~     and availability of HydroSoft® 3D, and at the discretion of the sponsor, additional~     patients, up to 300 patients total for the overall Study, with eligible aneurysms will be~     enrolled into Phase 2. In Phase 2 the aneurysm must be framed with HydroSoft® 3D and~     finished with HyperSoft® 3D and/or HyperSoft® helical coils. Data will be collected on~     immediate and post-treatment angiographic occlusion rates (RRGS), new peri-procedural~     imaging-confirmed hemorrhage or ischemic stroke, neurological morbidity and mortality rates,~     recurrence rates, bleeding rates, retreatment rates, serious adverse events, >150 day~     angiographic occlusion rates (RRGS) and occlusion status. This will serve to establish the~     acute and sustained efficacy of EVT of small intracranial aneurysms with the specified~     microcoils, aided by balloon and/or stent remodeling where appropriate.~   "
60956|NCT02259374|"~     TAP block performed under ultrasound guidance is used as part of multimodal analgesia to~     relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used~     include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve~     transmission of pain from the site of tissue injury. An important component of the pain~     experienced by patients after abdominal surgery derives from the abdominal wall incision.~     The abdominal wall sensory afferents course through the transversus abdominis (neurofascial)~     plane superficial to the transversus abdominis muscle. Single shot TAP block has been shown~     to provide pain relief of up to 24h in surgeries involving pfannenstiel incisions, hence a~     study period of 24h is chosen in patients undergoing hysterectomy.~      This study was designed to test the hypothesis that the TAP block, as part of a multimodal~     analgesic regimen, even at a lower concentration, would provide effective analgesia in the~     first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.~   "
60947|NCT02259491|"~     Since antiquity, honey has been recognized for its healing properties. Literature about the~     use of medicinal honey for wound care dates back centuries with recent data suggesting its~     use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey~     (Leptospermum scoparium) to have significant immune benefits and the ability to influence~     all phases of wound healing: inflammation, proliferation and remodeling. In addition,~     numerous clinical studies have identified positive benefits for wound healing. However,~     there is a lack of prospective, randomized controlled data on the use of honey as a~     medicinal agent in local wound care and scar healing.~      In order to better understand Manuka Honey's ability to aid in healing, the investigators~     are conducting a randomized, controlled, single-blinded study of patients undergoing~     reconstructive surgery. This project uses split thickness skin graft and free tissue~     transfer donor sites as standard wound models to compare the effects of Manuka Honey versus~     standard wound care therapies. Through the use of standard wound model and objective~     measurement tools, the investigators hope to better elucidate any benefits of this novel~     wound care 'technology.'~   "
60948|NCT02259478|"~     Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day~     cumulative dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be~     prospectively monitored using a standardized protocol for signs of hemolysis, and will be~     undergo additional testing for variables that have been hypothesized to increase the risk of~     hemolysis. The goal of the study is to define the incidence and dynamics of IVIG-mediated~     hemolysis and identify patient and product-related factors that may predict which patients~     are especially at risk.~   "
60949|NCT02259465|"~     Some carbohydrates, complex sugars, which are found in grains, fruit and vegetables, cannot~     be digested by humans. When eaten they pass through the small bowel to the large bowel, or~     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use~     them as an energy source. This releases energy that humans can absorb, and may have other~     effects on health as well. The process also releases gases such as hydrogen and methane into~     the colon, which will eventually be released as flatulence.~      There is some evidence in animals, and humans, that changing the carbohydrate content of the~     diet may increase the numbers of bacteria in the colon that can use this energy source.~     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect~     transit, the speed at which food and stool moves through the stomach and bowels.~      This undergraduate project will use techniques in Magnetic Resonance Imaging developed in~     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed~     of transit through the bowel and gas production in the colon, and whether there is any~     immune reaction to the carbohydrate from the bowel wall.~   "
60950|NCT02259452|"~     The purpose of the study is to assess the time, dose dependence, and fraction-size~     dependence of radiation (RT)-induced changes in regional lung and heart~     perfusion/function/structure following thoracic RT delivered using newer~     IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and~     predict RT-induced changes in regional lung and heart perfusion/function/structure with~     changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT~     lung and heart assessments to better understand RT-induced regional heart/lung changes.~   "
60951|NCT02259439|"~     Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading~     cause of morbidity and mortality.Patients admitted to hospital present higher mortality~     rates.The investigators lack the specific tools that allow us to easily classify and~     establish the individual prognosis for each patient during their hospitalization.~      Rational of the study:to identify the predictive factors for hospital mortality in~     critically ill patients admitted to hospital due to an episode of COPD exacerbation.~   "
60952|NCT02259426|"~     Primaquine (PQ) is currently the only available drug that can clear the mature transmission~     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist~     after artemisinin-combination therapy. A major caveat to the use of primaquine in mass~     adminsitrations for the reduction of malaria transmission is that metabolism of the drug in~     individuals with glucose-6 phosphate dehydrogenase (G6PD) deficiency can lead to transient~     haemolysis. The haemolytic side effect of PQ is dose-related. Haemolysis is more commonly~     observed after prolonged PQ treatment but has also been observed in African populations~     following a single dose of PQ. This haemolysis was self-limiting, largely restricted to G6PD~     deficient individuals and did not lead to clinical symptoms. Nevertheless, any drug-induced~     haemolysis is reason for concern and the World Health Organization has therefore reduced the~     recommended dose of single low dose primaquine from 0.75mg/kg to 0.25mg/kg. This dosage is~     deemed safe without prior G6PD or Hb screening. However, there is limited direct evidence on~     the extent to which this dosage of PQ prevents malaria transmission to mosquitoes.~      In the current study, the investigators will assess the efficacy of DP in combination with~     low-dose PQ to prevent onward malaria transmission. The investigators will perform the~     investigators study in individuals aged 5-15 years who are carry microscopically detectable~     densities of P. falciparum gametocytes. This age group is chosen because asexual parasite~     carriage and gametocyte carriage are common in this age group. All enrolled individuals will~     receive a full three-day course of DP, and will be randomized to receive a dose of~     primaquine or placebo with their third dose. Efficacy will be determined based on gametocyte~     carriage during follow-up, measured by molecular methods. For all individuals, the effect of~     treatment on infectivity to mosquitoes will be assessed by membrane feeding assays at two~     time points.~   "
60953|NCT02259413|"~     The purpose of this study is to determine whether participation in a 12 week exercise~     rehabilitation program is effective at improving physical function and quality of life in~     individuals starting chronic hemodialysis.~   "
60954|NCT02259400|"~     The purpose of this study is to determine whether two different strategies of Non Invasive~     Ventilation (NIV) have different effect on length and failure of NIV support in preterm~     infants with respiratory distress syndrome (RDS).~   "
60955|NCT02259387|"~     The overall objective of this proposal is to better define the relationship between~     perceived stress, hair cortisol, and migraine in adolescents. This will be done by creating~     2 arms of the study: those with migraines (cases) and those without migraines or headaches~     (controls). Each arm will answer several of the same questionnaires and have hair cortisol~     samples taken multiple times over the course of 12 weeks.~   "
60957|NCT02259361|"~     This study evaluates the effects of sustained-release oral dalfampridine in the treatment of~     upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized~     pilot study half of participants will dalfampridine, while the other half will receive a~     placebo.~   "
60969|NCT02259205|"~     This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted~     from olive mill waste in platelet aggregation and other inflammatory and oxidative stress~     markers. The study will include three groups: the intervention group will receive the~     enriched yogurt while the other two groups will serve as controls (plain yogurt and no~     yogurt consumption).~   "
60958|NCT02259348|"~     This pilot phase II trial studies how well a new reduced intensity conditioning regimen that~     includes haploidentical donor NK cells followed by the infusion of selectively T-cell~     depleted progenitor cell grafts work in treating younger patients with hematologic~     malignancies that have returned after or did not respond to treatment with a prior~     transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell~     transplant may help stop the growth of cells in the bone marrow, including normal~     blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's~     immune system from rejecting the donor's cells. When the healthy progenitor cells from a~     related donor are infused into the patient they make red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells (called graft-versus-host disease). Removing specific T cells from~     the donor cells before the transplant may prevent this.~   "
60959|NCT02259335|"~     Weaning from invasive mechanical ventilation is one of the major clinical problem especially~     ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.~      The aim of this pilot feasibility and safety trial is to assess the possibility of shorten~     the duration of mechanical ventilation using a device able to remove CO2 and theoretically~     able to allow therefore the praecox extubation~   "
60960|NCT02259322|"~     This study will test the effectiveness of two distinct behavioral treatments for loss of~     control eating following bariatric surgery:~        1. Behavioral Weight Loss Treatment~        2. Cognitive Behavioral Therapy~      These treatments will be compared to Standard-of-Care.~   "
60961|NCT02259309|"~     The present study is designed to address the null hypothesis that there is no difference in~     the local and systemic immunomodulatory effects of buccally or vaginally administered~     misoprostol in healthy, reproductive-age women.~   "
60962|NCT02259296|"~     The timing for arteriovenous fistula (AVF) creation and its effect on target organs in~     patients with chronic renal failure will be investigated by multicenter prospective cohort.~     Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for~     patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney~     disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic~     kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to~     undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months;~     primary and secondary patency rate of AVF, AVF construction on cardiac structure, function,~     encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the~     next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF~     creation~   "
60963|NCT02259283|"~     Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently~     the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo~     myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is~     performed, and has advantage over surgery because it is performed endoscopically, thus is~     less invasive. One potential disadvantage in respect to surgery may be that it may determine~     higher rates of post-operative reflux. The purpose of this study is to prospectively assess~     the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1,~     3 and 12 months.~      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of~     achalasia, without megaesophagus or colonic esophagus, will be included for the POEM~     procedure.~      This study will last about 2 years. The aim is the feasibility, security and success rate of~     POEM for achalasia. Patients will be followed for at least one year.~   "
60964|NCT02259270|"~     Acid suppressive therapy (AST) is used in a variety of indications in prevention and~     treatment of gastric acid related disorders. In recent years, an increase in the use of acid~     suppressive therapy has been documented. It has generally been accepted that these agents~     are effective and safe. However, very recently, reports describing hypomagnesaemia,~     hypocalcemia, vitamin B12 deficiency and enteric infections, were published.~      The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment~     with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness~     of initiation of AST and the appropriateness of continuation of AST at discharge in a subset~     of the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of~     inappropriate AST during hospitalisation will be calculated from these data.~      The primary endpoint is defined as the number of patients on long-term ambulatory AST after~     initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at~     the level of initiation during hospitalization and at discharge (appropriate continuation);~     also the impact on the hospital budget (lump sum budget) will be calculated, and potential~     cost avoidance for long-term ambulatory inappropriate AST will be estimated from a~     healthcare payer perspective for a period of 1, 3, 6 and 12 months.~   "
60965|NCT02259257|"~     Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization~     of the dynamic vascular features of the plaques, in a unique spatial format using three~     orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire~     vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature~     as viewed in various angles provides a realistic representation that is more easily~     appreciated. Inter-observer variability for individual plaques has been assessed and~     inter-observer variability and inter-scan variability (the analysis of multiple images from~     single patients in longitudinal studies) were dependent on plaque size, with larger plaques~     showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid~     plaque will provide added value for the depiction of the and quantification of intra-plaque~     blood vessel density by providing a true volumetric viewing area. This data will be~     correlated to the subsequent surgical specimens. The goal of the protocol is to investigate~     the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa~     vasorum using quantitative software analyses. The histology methods used for quantification~     of hemorrhage and vessel density analyses.~   "
60966|NCT02259244|"~     The purpose of this study is to evaluate the combined effect of physical activity and~     adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative~     stress in obese patients enrolled in the weight management reduction program.~   "
60967|NCT02259231|"~     Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for~     approximately three-fourths of all skin cancer deaths. For metastatic or unresectable~     melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab~     and nivolumab) and other therapies, however, approved therapies are rarely curative.~      It is now well accepted that tumors are able to evade detection and eradication by the~     immune system, even though many tumor types, particularly melanoma, are capable of eliciting~     a strong immune response (Swann, 2007). Substantial mechanistic work in recent years has~     revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells~     from the immune system, promoting both tumor progression and resistance to cancer~     immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of~     reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these~     reactive molecules and their by-products, such as nitrotyrosine, have been correlated with~     poor clinical outcomes in melanoma. Currently available melanoma therapies do not target~     MDSCs.~      In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity~     of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through~     inhibition of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in~     combination with T-cell-activating therapeutics such as ipilimumab to enhance the natural~     immune anticancer response. RTA 408 also has direct anticancer effects via inhibition of~     NF-kappa B. Chronic activation of NF-kappa B is associated with tumor progression,~     metastasis, and resistance to therapy.~      This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and~     pharmacokinetics of omaveloxolone (RTA 408) in combination with ipilimumab or nivolumab in~     patients with unresectable or metastatic melanoma.~      In this open-label, multicenter, dose-escalation, Phase 1b/2 study, patients who qualify~     will receive omaveloxolone (RTA 408) at the assigned dose level in combination with~     ipilimumab or nivolumab. Patients will receive omaveloxolone (RTA 408) orally once daily for~     1 week prior to initiation of ipilimumab or nivolumab. For patients treated with ipilimumab~     , the run-in period will be followed by omaveloxolone (RTA 408) orally once daily in~     combination with ipilimumab administered at Weeks 1, 4, 7, and 10. After Week 10, patients~     will receive maintenance treatment with omaveloxolone (RTA 408) alone once daily. For~     patients treated with nivolumab, the run-in period will be followed by omaveloxolone (RTA~     408) orally once daily in combination with nivolumab administered approximately every two~     weeks as clinically indicated. Each patient will continue at the assigned omaveloxolone (RTA~     408) dose level until disease progression occurs, toxicity requiring discontinuation from~     study drug (i.e., RTA 408) is experienced, the patient has completed approximately 72 weeks~     of treatment, the patient is discontinued from the study drug for another reason, or the~     patient withdraws consent. Patients will return 4 weeks after omaveloxolone (RTA 408)~     treatment completion for a follow-up visit.~      The starting omaveloxolone (RTA 408) dose level for the first dose-escalation cohort in this~     study has been selected based on available safety and pharmacodynamic data from a Phase 1~     study of RTA 408 (NCT02029729). Subsequent cohorts will be enrolled at dose levels based on~     available safety and PD data from this study, but they will not be greater than 2-fold above~     the prior dose level.~      Phase 1b (dose-escalation): In the phase 1b/2 portion of this study, 12 patients will be~     enrolled in each dose cohort, with six patients administered omaveloxolone (RTA 408) plus~     ipilimumab and the remaining six administered rTA 408 plus nivolumab. Subsequent cohorts~     will assess escalating the doses of omaveloxolone (RTA 408) administered in combination with~     ipilimumab or nivolumab. Dose escalation decisions will be based on ongoing review of all~     available safety information for enrolled patients.~      Phase 2: The Phase 2 portion of the study may include separate expansion cohorts consisting~     of patients treated with either of the combination therapies. Each expansion cohort will~     include an additional 24 patients enrolled at the selected Phase 2 dose level to achieve a~     total of 30 patients at that omaveloxolone (RTA 408) dose in combination with ipilimumab or~     nivolumab.~   "
69083|NCT02153099|"~     The purpose of this study is to characterize the safety and tolerability profile of~     escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose~     in healthy adults.~   "
60970|NCT02259192|"~     The purpose of this investigation is to determine the safety and preliminary efficacy of~     implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal~     hearing (NH) ear (termed single-sided deaf person, or SSD). The potential subjects will~     have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound~     from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The~     long-term goal of this research program is to determine whether the CI, in combination with~     the NH ear, may provide improved localization ability and better speech understanding in~     noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A~     secondary long-term goal is to determine whether CI stimulation may reduce tinnitus~     severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is~     turned off, after implantation.~   "
60971|NCT02259179|"~     This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy~     adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination~     trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the~     two drug products will be evaluated separately in the fed and fasted state.~   "
60972|NCT02259166|"~     The purpose of this study is to assess if the Enhanced Homestead Food Production Plus~     (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient~     Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among~     children after a blanket provision of MNP, and has an impact on child growth, infant and~     young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH~     and malaria prevention, food security and women's empowerment.~   "
60973|NCT02259153|"~     The objective of the study is to assess the effect of two diets with different fat~     composition on cholesterol metabolism. The study was a randomized cross-over trial where~     volunteers follow two study periods with different types of meat (lean and fat red meat)~     separately by a ten days wash-out period. At the beginning of the study and after the study~     periods the following parameters are determined: anthropometric (weight, waist,~     circumference and body mass index), blood pressure, dietary (72-hours dietary registry) and~     exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL~     cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring,~     ferritin, uric acid, glucose, HbA1c and insulin). Serum concentration of non cholesterol~     sterols (sitosterol, campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols~     (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by~     High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout~     along the study in order to demonstrate the effect of different red meat on the hepatic~     metabolism of cholesterol.~   "
60974|NCT02259140|"~     This randomized controlled trial will compare proximal femoral resection-interposition~     arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the~     treatment of painful irreducible hip dislocation in patients with cerebral palsy. The~     primary outcome is quality of life and care giver burden measured by The Caregiver~     Priorities and Child Health Index of Life with Disabilities (CPCHILD) score at one year.~     Secondary outcomes will include fluoroscopy and surgical times, blood loss, hip migration,~     sitting and standing tolerance, complications, need for additional surgical procedures,~     OUCHER and CPChild and cost. A cost-effectiveness analysis will follow completion of the~     randomized controlled trial (RCT). The authors hypothesize that mean CPCHILD scores~     (measured at 1 year) will be significantly higher following the Subtrochanteric Valgus~     Osteotomy technique compared to Proximal Femoral Resection-Interposition Arthroplasty~     technique. Furthermore, the Proximal Femoral Resection-Interposition Arthroplasty technique~     will have a shorter length of hospital stay, shorter fluoroscopy and OR times and the~     Subtrochanteric Valgus Osteotomy will have longer sitting tolerance, less pain, smaller~     burden for caregivers, better health, and higher quality of life. Additionally the authors~     hypothesize that Subtrochanteric Valgus Osteotomy will be more expensive than Proximal~     Femoral Resection-Interposition Arthroplasty, due to the cost of the plate, longer operative~     time, longer length of stay, and blood loss, but Subtrochanteric Valgus Osteotomy will be~     preferred by patients due to less pain and better functional and quality of life~     outcomes.The results of this study are expected to improve outcomes for children with~     cerebral palsy with painful irreducible dislocated hips.~   "
60975|NCT02259127|"~     A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is~     non-inferior to the standard combination of medicines used in terms of efficacy and better~     in terms of toxicity.~   "
60976|NCT02259114|"~     Open-label, phase I, non-randomized, multicentric study of single-agent OTX105/MK-8628~     administered according to two distinct regimens to participants with selected advanced~     tumors.~      The study will be performed in two parts.~      Dose Escalation Part:~      This step is designed to determine the maximum tolerated dose (MTD) in each of the two~     regimens, which will be evaluated in parallel. Participants will receive oral OTX105/MK-8628~     according to:~      Continuous Dosing Regimen: continuous, once daily for 21 consecutive days (21-day cycles).~      OR Days 1-7 Dosing Regimen: once daily on Days 1 to 7, repeated every 3 weeks (21-day~     cycles; 1 week ON/2 weeks OFF).~      Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing~     Regimen according to the next available place and receive OTX105/MK-8628 at escalating doses~     levels (DL). Cohorts of 3 participants will be treated, and an additional 3 participants~     will be treated at the first indication of dose-limiting toxicity (DLT). MTD assessment will~     be based on the tolerability observed during the first 21 days of treatment.~      Expansion Part:~      The efficacy of OTX105/MK-8628 in each of the five indications (i.e., Bromodomain-Nuclear~     Protein in Testis [BRD-NUT] midline carcinoma, triple negative breast cancer [TNBC],~     non-small cell lung cancer [NSCLC] harboring a rearrangement Anaplastic Lymphoma Kinase~     [ALK] gene/fusion protein or Kirsten Ras [KRAS] mutation, castrate-resistant prostate~     cancer, and pancreatic ductal carcinoma) will be assessed in terms of response (Response~     Evaluation Criteria in Solid Tumors v1.1 [RECIST v1.1] or Prostate Cancer Clinical Trials~     Working Group 2 [PCWG2]) using a selected regimen.~   "
60977|NCT02259101|"~     The proposed study will consist of a randomized controlled trial (RCT) comparing a known~     efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.~   "
60978|NCT02259088|"~     Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular~     edema (DME)~   "
60979|NCT02259075|"~     Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as~     headaches for at least 15 days per month, of which 8 days have typical migraine features. In~     many cases, oral drug treatment has little effect.~      The parasympathetic nervous system acting through the sphenopalatine ganglion may be~     involved in several primary headaches, including migraine, by facilitating release of~     inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion~     of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.~      The purpose of the present study is to evaluate a new technique with injection of BTA using~     an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The~     goal is to relieve the migraine symptoms and develop an alternate treatment for cases where~     oral drug treatments fail.~      The main objective of the project is to determine the safety of this method of BTA injection~     in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives~     are to measure changes in headache attack parameters with this novel method.~   "
60980|NCT02259062|"~     Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation~     focuses primarily on physical disability and activities of daily living. By contrast,~     relatively little research attention has been paid to the potential for cognitive~     rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood~     and cognitive difficulties with attention and memory are common post stroke leading to~     poorer recovery, emotional wellbeing and quality of life yet accessible and effective~     therapies are lacking.~      Engagement in leisure activities may enhance recovery after stroke but participation in~     leisure activities is reduced following stroke. Music listening is a low cost and accessible~     leisure activity that has been suggested to improve mood and cognition poststroke. The~     investigators speculate that music listening may enhance control of attention in a similar~     way to mindfulness interventions, that have been demonstrated to be beneficial in the~     treatment of mood disorders. The investigators propose that adding a brief mindfulness~     intervention to music listening might enhance the effect on control of attention, with~     positive effects on cognition and mood poststroke but the feasibility and acceptability of~     this intervention needs to be evaluated before attempting a further trial assessing the~     effectiveness of this intervention. The investigators aim to recruit 100 patients within two~     weeks poststroke.~      Participants will be randomly assigned to receive an 8 week music listening alone, music~     listening with brief mindfulness or audiobook listening intervention alongside treatment as~     usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3~     months, and 6 months poststroke In addition, participants will be interviewed about their~     experience of engaging in the interventions.~   "
60981|NCT02259049|"~     The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour~     blood pressure fluctuations in individuals with Parkinson's disease.~   "
60982|NCT02259036|"~     The primary goal of this research study is to develop an interactive smartphone app that~     could be used to increase the effectiveness of talk therapy such as cognitive behavioral~     therapy (CBT) for child anxiety.~   "
60983|NCT02259023|"~     Purpose:~      The objective of this study is to determine the effect different sources and forms of~     discretionary foods have on stress perception in healthy adults in a free living, real world~     setting.~      Rationale:~      The rationale for conducting this study is to test the effects of sugar-sweetened beverages~     and grain-based desserts have on perceived health and stress perception, since the evidence~     for this topic is limited.~   "
60984|NCT02259010|"~     This study will assess the effect of multi-dose administration of itraconazole on the~     single-dose pharmacokinetics (PK) of alisertib.~   "
60985|NCT02258997|"~     The investigators propose that patients with HbSβ-thalassemia have lower levels of hepcidin~     and higher levels of GDF-15 than HbSS patients during the non-crisis, steady states. In~     addition, the investigators propose that when controlled for RBC transfusion, patients with~     HbSβ-thalassemia will have higher levels of storage iron (based on serum ferritin).~      Participants: Total number of subjects is 42 - 21 subjects with HbSS, and 21 subjects with~     HbSβ-thalassemia ).~      Procedures (methods): Eligible subjects with documented SCD (HbSS, HbS-β 0-thalassemia or~     HbS-β+-thalassemia) followed at the University of North Carolina (UNC) Comprehensive Sickle~     Cell Program will be evaluated in this single-center, prospective, cross-sectional study.~     The patients will be screened for eligibility at the time of a routine sickle cell clinic~     visit. Patients' data will be obtained in person at the time of evaluation and through~     review of their medical records. Investigators will obtain information on SCD-related~     clinical complications and obtain an estimate of the number of lifetime RBC transfusions.~     Blood samples will be obtained for laboratory tests. Plasma samples for hepcidin, growth~     differentiation factor 15 (GDF -15), and high-sensitivity CRP will be stored at -80 degrees~     Celsius until analysis. Other routine laboratory studies including complete blood count~     (CBC) with differential and reticulocyte count, serum iron profile and ferritin, and liver~     function tests will be performed at the clinical laboratories of UNC Hospitals.The subjects~     will have 30 ml. of blood drawn for this research study. Females of child bearing potential~     will have a urine pregnancy test at the time of the study.~   "
60986|NCT02258984|"~     The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP~     system has on the management of emergency department (ED) patients with fluid sensitive~     conditions.~   "
60987|NCT02258971|"~     Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites~     CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion~     pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180~     BR~      Secondary objectives: To determine safety and tolerability following single dose oral and iv~     administration of BEA 2180 BR in healthy male volunteers.~   "
60998|NCT02258828|"~     Twenty six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an~     open label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and~     Letter-Number Sequencing subtests of the Wechsler Memory Scale III (Third edition) and the~     Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS measures~     attention, language, visuospatial skills, and immediate and delayed memories. The Clinician~     Administered PTSD Scale (CAPS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale~     (HAM-A), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Sheehan~     Disability Scale (SDS) were used to assess improvement in PTSD symptoms, as secondary~     outcome measures.~   "
60999|NCT02258815|"~     A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five~     consecutive days will be administered every 4 weeks, starting 60-180 days after previous~     haploidentical stem cell transplantation.~      Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants~     will be premedicated with an intravenous antihistamine and ranitidine within approximately~     30 minutes prior and during the infusion of the study agent Pain as an anticipated side~     effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status~     will be evaluated after 3 and 6 courses and after 1 year~   "
60988|NCT02258958|"~     Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting~     in significant morbidity, mortality and resource utilization. The true incidence is unknown,~     and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis~     in thoracic surgery includes administration of unfractionated or low molecular weight~     heparin starting at the perioperative period and finishing at the time of patients'~     discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35~     days has become the standard of care. There is a clear need to systematically evaluate the~     incidence of VTE after resection of lung malignancies and to evaluate the role of extended~     VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after~     those major lung resections. This study will involve patients undergoing lung resection for~     malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto~     General Hospital. The study will include 150 consecutively recruited patients. Study~     interventions will include Computed Tomography with pulmonary embolus (PE) protocol and~     bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days~     post-surgery.~      In summary, this study is aimed at evaluating, for the first time in a prospective manner,~     the actual incidence of DVT and PE in patients undergoing major lung resections for~     malignancies. The knowledge gained in this study will be used to inform a future~     investigation involving a Randomized Controlled Trial (RCT) to compare current~     post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope~     of providing an evidence-based practice change in VTE prophylaxis care for this high risk~     population.~   "
60989|NCT02258945|"~     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for~     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin~     infusion (CSII) is an effective method of achieving this. Among the advantages of CSII is~     the opportunity for patients to potentially discard relatively inflexible mealtimes and~     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).~     There are also reported improvements in quality of life. Furthermore, in patients with good~     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic~     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;~     potentially leading to increased cardiometabolic risks. Literature examining the eating~     behaviours, quality of life and cardiometabolic risks of CSII patients over time after~     commencement of the therapy is sparse, frequently dated and worthy of further research.~   "
60990|NCT02258932|"~     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for~     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin~     infusion (CSII) is an effective method of achieving this. Among the advantages of CSII is~     the opportunity for patients to potentially discard relatively inflexible mealtimes and~     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).~     There are also reported improvements in quality of life. Furthermore, in patients with good~     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic~     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;~     potentially leading to increased cardiometabolic risks. Literature examining the eating~     behaviours, quality of life and cardiometabolic risks of CSII patients over time after~     commencement of the therapy is sparse, frequently dated and worthy of further research.~   "
60991|NCT02258919|"~     Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality~     rates up to 52% at 30 days. It is a major public health problem with an annual incidence of~     10-30 per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes~     worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in~     patients with malignant middle cerebral artery (MCA) infarction. Based on the common~     pathophysiological mechanisms of these two conditions, this procedure is also frequently~     performed in patients with ICH, but is has not yet been investigated in a randomized trial.~      The primary objective of this randomized controlled trial is to determine whether~     decompressive surgery and best medical treatment in patients with spontaneous ICH will~     improve outcome compared to best medical treatment only.~      Secondary objectives are to analyze mortality, dependency and quality of life. Safety~     endpoints are to determine cause of any mortality and the rate of medical and surgical~     complications after DC compared with best medical treatment alone.~   "
60992|NCT02258906|"~     Ulinastatin reduces systemic inflammatory responses and protects organs from~     ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of~     ulinastatin on postoperative renal function in patients undergoing robot-assisted~     laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for~     robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and~     control (n=35) groups. Randomly selected patients of the ulinastatin group are given~     ulinastatin. In contrast, patients in the control group receive an equivalent volume of~     normal saline as a placebo. The primary endpoints are postoperative renal function measured~     by serum creatinine, cystatin C, and urine output.~   "
60993|NCT02258893|"~     The purpose of this study is to determine whether reducing indoor exposure to NO2 and~     particles improves respiratory health in children with asthma.~   "
60994|NCT02258880|"~     The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to~     determine whether SUN13837 improves the physical performance, relative to placebo, following~     an acute stroke in adult subjects.~   "
60995|NCT02258867|"~     The objective of this study is to assess the efficacy and safety of gevokizumab in treating~     Behcet's disease uveitis (BDU).~   "
60996|NCT02258854|"~     The purpose of this study is to provide continued dosing of gevokizumab in order to obtain~     and assess long-term gevokizumab safety data.~   "
60997|NCT02258841|"~     The purpose of this study is to assess the effectiveness of an interactive, online safety~     decision aid among diverse Canadian women who are experiencing intimate partner violence~     (IPV). The investigators will also explore how the online intervention works, and whether it~     has different effects for different groups of women.~   "
61000|NCT02258802|"~     The purpose of this study is to develop, implement and evaluate a psychoeducational~     intervention focused to improve nutritional status, specifically micronutrients, of mothers~     and caregivers of children between the ages of 5 and 13 years and their children through~     providing healthy cooking lessons in their communities.~   "
61001|NCT02258789|"~     There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By~     using virtual technology, a new method (virtual reality, VR method) has been created which~     focuses on stimulating attention networks: top down scanning training in a 3D game, combined~     with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor~     training.~      Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as~     well as before and after training with the new VR method Method:- An intense visio spatial~     scanning training, enhanced by directed visual, audio and tactile stimulation cues and~     feedback, also including visio-motor activation was designed in a VR game. The in-house~     developed software was based on the Tetris game. The VR method consists of an interactive 3D~     environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15~     patients with chronic (>6 months) visio spatial neglect was included due to right-sided~     ischemia. A VR neglect test battery including a Posner task were repeated three times during~     a 5 weeks baseline before the training started (to establish the chronic state) and again~     after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training~     attention after stroke causing visio spatial neglect.~      The method has been designed for home rehabilitation and is well suited for a tele-medicine~     approach. It was built with standard components and is easy to manufacture at a low cost.~     The idea is to give access to effective training, to make it available at the stroke unit~     with the possibility for the patient to loan it it at discharge for home rehabilitation. The~     concept of an all in one, easy-to-use device for testing, training and outcome evaluation~     should be beneficial These preliminare results has been promising and indicates that the~     RehAtt™ method could become an further developed into an effective and stimulating~     intervention tool that would lower rehabilitation costs and reduce tiresome travelling to~     hospitals for training.~   "
61002|NCT02258776|"~     The purpose of this study is to determine the efficacy of pomegranate extract and~     pomegranate juice on skin inflammation and aging. The information gained from this study may~     lead to the development of a pomegranate product that can decrease the effects of aging,~     inflammation and harmful bacteria on the skin.~      In this study, two pomegranate products (extract and juice) will be compared with a placebo,~     a study product that looks like pomegranate extract, but contains no active ingredients.~   "
61003|NCT02258763|"~     To determine, in children hospitalized with pneumonia, if an extended duration of oral~     antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in~     improving clinical outcomes.~      Secondary Aims:~        1. Describe the prevalence of respiratory viruses and bacteria at presentation.~        2. Investigate the depression, anxiety and stress scores (DASS21) and quality of life~          scored (QOL) by parents of the children during admission, pre-discharge and post~          discharge and at follow-ups.~   "
61004|NCT02258750|"~     This study will examine the impact of a soluble fibre (polydextrose) incorporated into a~     high fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers~     of satiation and satiety over 4-weeks. Specifically, the impact on the development of~     satiation within the fixed-load tomato soup containing the fibre, the development of satiety~     after the fixed-load meal containing fibre and intake at subsequent ad libitum meals will be~     examined as well as the insulin response and carbohydrate fermentation before and after~     4-week dosing of the preload soup.~   "
61005|NCT02258737|"~     Efficacy of transitional case management following psychiatric hospital discharge: a~     randomized trial~      Background The movement of deinstitutionalisation in Western societies has modified the role~     of psychiatric hospital, which has lost its asylum function to become a place for acute~     care.~      Psychiatric stays are now shorter and close interactions with the outpatient care network is~     therefore more critical than before. The first weeks following discharge from psychiatric~     hospital represent a period of high risk for relapse, readmission or even suicide. Case~     management has a proven efficacy in facilitating patients' deinstitutionalisation after very~     long hospitalisations and in stabilizing high users of psychiatric care. In contrast,~     studies exploring the impact of time limited case management following discharge from short~     stays (transitional case management) in earlier phases of psychiatric disorders in~     connection with primary care are lacking.~      Working Hypotheses The investigators hypothesize that transitional case management following~     hospital discharge decreases risk of readmission, improves adherence to outpatient care,~     facilitates recovery and improves patients' satisfaction with treatment as compared to~     routine care.~      Specific Aims In this study, the investigators will compare the impact of both intervention~     on number of contact and level of adherence to outpatient care. The investigators will also~     compare both groups on number of readmission, risk of early aggravation of the disorders,~     level of functioning and satisfaction with care.~      Methods This is a randomized single-blind study comparing transitional case management after~     discharge with routine post-hospitalization care for subjects living independently without~     institutional psychiatric follow-up. Demographic and clinical data will be gathered during~     hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of~     outcomes using validated instruments will be: contact and level of adherence to outpatient~     care (primary outcomes), as well as number of hospitalization days, number of readmissions,~     severity of illness and satisfaction with care (secondary outcomes).~      Expected Value of the Proposed Project This study should improve psychiatric patients~     follow-up in collaboration with the different levels of care in the global context of~     deinstitutionalization.~   "
61006|NCT02258724|"~     Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of~     the children with congenital heart disease reach adult age.This results in an increasing~     number of adults or grown-ups with congenital heart disease (ACHD or GUCH patients) that~     require special health care organization and training programmes. Long term complications of~     these GUCH patients and optimum treatment strategies are still poorly known. The aim of this~     registry is to collect quantitative and qualitative data regarding GUCH patients treated in~     specialised centres in Switzerland.~   "
61007|NCT02258711|"~     Bipolar disorder is a frequent condition in the general population with a high~     morbimortality, which consists in dysfunctional temporal fluctuations between different mood~     phases ranging from depression to manic episodes with frequent subsyndromal symptoms between~     them. Usually during these phases, the subjects have a lack of insight about the diagnosis~     and symptoms. Besides the pharmacological treatment, additional psychological interventions~     have shown to improve the long-term outcome of the disorder, yet taking into account the~     limited resources currently available, its general implementation is still difficult and~     costly. Among these interventions, group psychoeducational programs have proved to be~     cost-effective in helping patients recognize early signs and symptoms in order to prevent~     full blown episodes which very usually are associated with a high morbidity and hospital~     admissions.~      On the other hand, numerous projects have tested the potential benefits of new technologies~     such internet in the treatment of bipolar and psychotic disorders patients using either~     online signs and symptoms monitoring or web-based psychoeducational programs, yet to the~     investigators knowledge, none of them have integrated both approaches in one single~     intervention.~      The hypothesis that, combining both interventions (signs and symptoms monitoring along with~     psychoeducational contents) in a single smart-phone application will prove to be at least~     equal or superior in terms of efficacy comparing to the standard treatment, seems promising,~     given the fact that both approaches have independently demonstrated their efficacy in the~     same population. This could extend the range of the patients in whom this kind of additional~     interventions could be implemented; preventing relapses, suicide attempts, consultations and~     hospitalizations at a much lower cost.~   "
61039|NCT02258295|"~     This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of~     hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally~     been used to treat knee osteoarthritis. There are a small number of studies in the~     literature that suggest that HA injections can be very effective for tendinosis. Although LE~     has been studied with literally hundreds of articles published, very little treatment has~     proven to be efficacious. This study will investigate the effectiveness of hyaluronate in~     treatment of chronic LE. This will include a three arm study with two formulations of HA~     tested against saline injections as the control.~   "
61040|NCT02258282|"~     The purpose of this study is to evaluate safety and efficacy of etanercept in patients with~     psoriasis who had an unsatisfactory response to traditional DMARDs.~   "
61041|NCT02258269|"~     The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.~   "
61008|NCT02258698|"~     BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response.~     Insulin resistance plays an intriguing role in these metabolic alterations and depends on~     the intensity of injury. Metabolic derangements resulting from peripheral insulin resistance~     are unambiguously related to adverse outcomes and higher perioperative complication rates.~     Therefore, insulin resistance offers to act as a marker for stress and is potentially~     relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an~     established indicator for blood glucose control and has a prognostic value regarding~     outcomes after major surgical interventions.~      Adipose tissue holds a key function in endocrine metabolism by releasing multiple~     substances, so-called adipose-derived secreted factors or adipokines. Recent studies have~     linked several adipokines to overall insulin sensitivity in metabolic syndrome-related~     conditions as well as in critical illness. Irisin, a recently identified myokine acts on~     white adipose tissue and plays a role in the prevention of insulin resistance.~      AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of~     perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on~     previous studies suggesting glucose homeostasis and insulin resistance are associated with~     severity of illness and outcome in critically ill patients,it is proposed that patients with~     marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates~     the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check~     index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif~     chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin~     resistance and explores for correlation with adverse clinical outcomes after 30 days.~      MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective~     on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine~     blood samples will be assessed the day before surgery. Study blood samples will be drawn~     preoperatively in the induction bay of anesthesia to measure the insulin resistance indices~     HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin,~     adipokines, and routine biochemical tests will be assessed upon admission to the intensive~     care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after~     surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.~   "
61009|NCT02258685|"~     This study plans to learn more about immune responses in intestinal (gut) tissue in people~     with human immunodeficiency virus (HIV) infection. This study will determine whether change~     in the composition of gut bacteria in HIV infected individuals is related to a high~     prevalence of chronic gut inflammation and metabolic disease. The investigators will also~     investigate immune-modulatory properties of specific bacteria that correlate with disease~     both by characterizing which functional genes are selected for in their genomes and by~     stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This~     work will establish whether gain/loss of bacterial drivers/suppressors of information in the~     gut contributes to metabolic disease in HIV-infected individuals.~   "
61010|NCT02258672|"~     The purpose of the present study is to evaluate the effectiveness of a prehabilitation~     program on the recovery of patients undergoing a minimally invasive surgery for degenerative~     lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two~     groups; intervention or control group. Participants in the intervention group will take part~     in a physical training program, three times a week for six weeks before undergoing surgery.~     The exercise program will be supervised and will aim at improving core muscles strength and~     endurance as well as spine stability. It is hypothesized that the prehabilitation program~     will significantly improve disability and pain intensity reported by patients after surgery.~     Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but~     its results may also impact the management of patients awaiting spine surgery for various~     conditions.~   "
61011|NCT02258659|"~     This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle~     formulation) and carboplatin followed by response-based local therapy in treating patients~     with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in~     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin,~     hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells.~     Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and~     reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and~     radiation therapy based on response (response-based therapy) and giving patients who are~     responding well lower doses of treatment may help reduce the occurrence of side effects.~   "
61012|NCT02258646|"~     This research project aims to conduct a three-arm multi-center randomized controlled trial~     (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive~     pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term~     integrated telerehabilitation involving exercise training at home, telemonitoring, and~     education/self-management will prevent hospital readmissions, thus reducing healthcare~     costs, for patients with COPD, and will improve patient status and quality of life.~   "
61013|NCT02258633|"~     The study will use a randomized controlled design testing the effectiveness of the following~     intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC).~     The study will identify children ages 2-14 at a pediatric trauma center. Children and their~     parents who agree to participate in the study will then complete a screening survey to~     identify part time seatbelt use. Those who screen positive will complete a more detailed~     baseline survey and then be randomized to one of two study conditions. At one month, a~     follow up assessment by telephone will be completed.~   "
61014|NCT02258620|"~     The radial approach for a coronary angiography is currently adopted by several centers~     because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in~     intra-arterial have been widely studied in prevention of this spasm. No studies have~     compared the different routes of administration of nitrates as a patch and a continuous~     intravenous injection.~   "
61015|NCT02258607|"~     This study is conducted in two phases. The Dose-finding Lead-in Phase, Part A, will evaluate~     the safety and determine the maximum tolerated dose (MTD) of momelotinib (MMB) when combined~     with trametinib. Once the MTD of MMB is determined, the study will proceed to the~     Dose-finding Lead-in Phase, Part B, to determine the MTD of trametinib. After the MTD is~     established, the study may proceed to an expansion phase to determine the efficacy, safety,~     and tolerability of MMB combined with trametinib at the MTD in participants with kirsten rat~     sarcoma viral oncogene homolog (KRAS) mutated metastatic non-small cell lung cancer (NSCLC).~     Each treatment cycle will consist of 28 days and treatment will continue in the absence of~     disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of~     treatment.~   "
61054|NCT02258087|"~     Investigators compare in a randomized clinical trial the results and side effects of~     high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ~     confined prostate cancer patients.~   "
61055|NCT02258074|"~     The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and~     lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients~     with Chronic Kidney Disease (CKD) stages 3-4.~   "
61016|NCT02258594|"~     The purpose of this project is to refine, implement, and evaluate a multi-component~     intervention that achieves sustainable and meaningful impact on healthcare quality, safety,~     and costs while ensuring dignity and respect for adult oncology and intensive care patients~     and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through~     Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this~     by enhancing the patient-provider relationship and introducing patient-centered approaches~     to multi-disciplinary communication and patient education. The PROSPECT framework is based~     upon a validated structured, team-work training model and novel web-based technology. The~     overarching goals of this project are to achieve the following:~        1. Optimize the overall experience of patients (including their family/care partners) by~          promoting dignity/respect, encouraging engagement, improving care plan concordance, and~          enhancing satisfaction.~        2. Minimize preventable harms in two environments: intensive care and acute care oncology~          units.~        3. Reduce unnecessary healthcare resource utilization and associated costs.~   "
61017|NCT02258581|"~     This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the~     HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only~     individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).~   "
61018|NCT02258568|"~     This study will assess the extent of postpartum smoking relapse among Romanian women, the~     associated risk factors, and will develop, implement, and pilot-test a randomized trial~     smoking relapse intervention incorporating innovative research concepts in a social and~     cultural acceptable manner. The primary hypothesis is that the intervention will increase~     mothers' smoking abstinence rates.~   "
61019|NCT02258555|"~     This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with~     follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL),~     or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic~     (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in~     future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with~     FL, MZL, CLL, or SLL.~   "
61020|NCT02258542|"~     The purpose of this study is to characterize the safety profile of benralizumab~     administration in asthma patients who have completed one of the three predecessor studies:~     D3250C00017, D3250C00018 or D3250C00020.~   "
61021|NCT02258529|"~     This study will evaluate the overall response rate (ORR) and complete response (CR) rate to~     treatment with idelalisib in combination with rituximab in participants with follicular~     lymphoma (FL) and small lymphocytic lymphoma (SLL) who have not received prior treatment.~   "
61022|NCT02258516|"~     Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of~     a new, theoretically based intervention to improve medication adherence in persons with HF.~     The hypotheses include:~      Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention~     (n=40) will be more adherent to medicines during the12-month intervention than a control~     group (n=40) of poorly adherent patients with symptomatic HF.~      Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention~     (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits~     during the 12-month intervention than a control group of poorly adherent patients with~     symptomatic HF.~      Study Activities and population - A prospective, randomized controlled design will be used~     to pilot test the efficacy of a new intervention to promote adherence to the medication~     regimen in chronic heart failure in the clinical setting. The initial development and~     feasibility testing of the intervention is complete (Preliminary Work, Section 4.5).~      Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor~     adherence, as determined by a validated screening measure, the Medication Adherence Scale~     (MAS)89 at baseline assessment, will be recruited and randomized to receive the intervention~     or usual care with attention control. Medication adherence, symptom frequency and intensity,~     hospital readmissions (HR) and emergency department (ED) visits will be assessed in both~     groups at 3, 6 and 12-month clinic visits. The intervals between visits are considered~     sufficient to minimize sensitization bias to psychometric measures. Longitudinal measurement~     is required to evaluate the magnitude of change in adherence and symptom-related events~     occurring over time. Efficacy will be measured as improved adherence (primary outcome) and~     decreased HR and ED visits (secondary outcomes) in the intervention group as compared to the~     attention control group at 12 months. The study will close when all patients have had a~     12-month post-enrollment clinic visit.~      Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear~     models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic~     generalizations of the traditional, multivariate GLM are appropriate when the dependent~     variable is binary and the probability of an event is modeled, as is the case with adherence~     in this study. When the dependent variable is a count, a commonly used generalized model~     uses the natural logarithm of the count, as with re-hospitalizations and ED visits in this~     study. In compliance with NIH guidelines for data safety and monitoring activities, a number~     of quality control steps will be used to ensure the on-going safety of participants and the~     scientific integrity of this feasibility intervention study. The proposed study poses only~     very minimal risks to participants. All participants will receive usual care. Participation~     in the study will not replace patients' regular health care attention. Data safety will be~     monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study~     co-investigators. Any adverse events will be reported immediately to the Duke IRB and the~     NIH.~      Data Safety. First, a project database will be constructed, using participant ID numbers and~     including all demographic, pre- and post-intervention history and all assessment materials.~     A separate file, cross-referencing participant identification with project ID numbers, will~     be maintained with access limited to the PI or a designated member of the investigative~     team.~   "
61023|NCT02258503|"~     The pain of the elderly is even often unrecognized or trivialized and ignored in spite of~     its big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 %~     of those living in institution and 80 % of this population at the end of life.~      So in the elderly, the noxious character of the pain is more pregnant than at the young~     adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to~     deteriorate the isolation and the dependence: the echo on the psychic state is frequent and~     the pain is a part of the cause of a confusional state. Finally, the presence of a pain~     distorts considerably the quality of life and can modify the state general as the desire of~     life.~      The evaluation of the pain appeals to the same strategy as to the younger subject but with~     some specificities, related more to the pathologies associated with the ageing than with the~     real age. For that purpose, the investigators have first of all scale of self-assessment as~     the numerical scale which is adapted to estimate the acute and chronic pains but this scale~     presents a bias because, certain patients do not express spontaneously their pain and this~     one must be attentively looked for in case of modification of behavior.~      So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to~     care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow~     within one minute a good quality evaluation whatever is the place of care) whose objective~     is the observation of the behavioral changes caused by the acute pain in elderly having~     communication disorders.~      Due to the demographic evolution, emergency departments are more and more frequently a place~     of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of~     all the passages in emergency department and 50 % of the patients hospitalized during the~     passage in the reception of Emergency department are elderly. Elderly care is difficult for~     a certain number of reasons (vulnerability, accumulation of pathologies and treatments). So,~     in this context, the evaluation of the presence of pain and its care are difficult in~     particular at the elderly with communication disorders.~      In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on~     700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of~     analgesic while 13 % only had a real quotation of the pain.~      The aim of the investigators study is to analyze if the systematic introduction of the scale~     Algoplus® in the evaluation of elderly during its entrance to emergency department could~     modify the prescription of analgesic.~   "
61024|NCT02258490|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of~     treatment for hematological abnormalities. Poor graft function, occurs when there poor donor~     engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result~     in improvement, but can potentially increase the incidence of graft versus host disease.~     Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an~     attractive alternative for treatment of poor graft function as it may be associated with~     less Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are~     using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of~     allogeneic hematopoietic progenitor cell (HPC) transplants for patients who have had prior~     stem cell transplants and require a stem cell boost from the original donor.~   "
61025|NCT02258477|"~     To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a~     non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test~     whether there is a threshold of glucose that will result in improved ease of resistance to~     problem foods (tested by comparing three different levels of glucose).~   "
61026|NCT02258464|"~     The objective of this study is to assess efficacy and safety of radium-223 dichloride in~     subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone~     receptor positive breast cancer with bone metastases treated with hormonal treatment~     background therapy.~   "
61027|NCT02258451|"~     The objective of this study is to assess efficacy and safety of radium 223 dichloride in~     subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor~     positive breast cancer with bone metastases treated with exemestane and everolimus.~   "
61028|NCT02258438|"~     The investigators propose in this project to determine the effect of 3 days of frequent~     interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults~     (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a~     control condition where subjects do not exercise but are subjected to prolonged sitting. The~     investigators believe that this proposed project will provide an initial evidence base for~     the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity~     activity, like walking.~   "
61029|NCT02258425|"~     In Phase I of this R34, the team from the University of California Los Angeles, San~     Francisco, and Irvine researchers plan to utilize the successful community participatory~     approaches to refine a gender-sensitive criminogenic needs -focused intervention program,~     Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory~     board, composed of homeless female offenders (HFOs) and addiction staff; and finalize~     strategies which will be validated by focus group sessions with the HFOs. In Phase 2, the~     research team will randomize 130 HFOs participating in one of two residential drug treatment~     programs to assess the impact of the FEM-CARE or a Health Promotion control program on~     reduction of drug and alcohol use and recidivism. This study is based upon our team's~     history of promoting theoretically-based, culturally sensitive nurse-led interventions that~     are enriched with criminal justice theoretical perspectives, and have resulted in~     significant reductions in drug and alcohol use among homeless persons, many of whom have had~     a history of incarceration.~      Specifically, the study aims are:~      AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff,~     further conceptualize our community-based program, Female Ex-Offender Mentoring in Care~     (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine~     the program in focus group discussions with 12 HFOs.~      AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at~     six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program,~     in terms of a) self-reported and/or objective measures of drug and alcohol use; and b)~     prevalence of recidivism and number of days to first reincarceration.~      Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six~     months than HFOs in the HP control program.~      Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and~     greater number of days to first reincarceration than HP control HFOs.~   "
61030|NCT02258412|"~     This study will evaluate the immediate antimicrobial efficacy and persistence of two hand~     hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on~     hands using the hand print method. It is hypothesized that the product containing~     Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in~     less bacterial growth on the hand print plates. In addition, environmental monitoring for~     cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas~     using Rodac plates and adenosine triphosphate tests.~   "
61031|NCT02258399|"~     The ability to control our blood glucose (sugar) concentrations after a meal is a strong~     predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the~     amount of glucose from the liver entering the bloodstream. At the same time muscle increases~     the amount of glucose it take up from the bloodstream. This ensures that our blood glucose~     levels do not get too high. The investigators want to understand what happens to these~     processes following exercise after breakfast and after an overnight fast. In addition, the~     investigators also want to understand whether exercising with or without breakfast~     influences our appetite, food intake and activity levels later in the day.~   "
61032|NCT02258386|"~     The aim of the present study is to implement a novel body-worn sensor, the ZephyrTM~     BioModule (the registered name for the wearable sensor device used in our study), for~     assessing physical activity and physiological measures in a clinical setting together with~     other clinical routine assessments. Our specific aim is to explore whether and how specific~     physical activity pattern and physiological measures are associated with delirium in~     hospital inpatient. Our ultimate goal is early detection and intervention of delirium, and~     better management through monitoring of activity pattern and physiological information. The~     ZephyrTM a U.S. FDA-approved wireless, ambulatory physiological monitoring device that~     consists of a data logger and transmitter unit which is attached at the location of the 5th~     intercostal space using a specifically designed patch (BioPatchTM) and standard ECG~     electrodes. The ZephyrTM is designed for long-term measurement of a patient's physical~     activity and physiological measures. By using the physical activity parameters and~     physiological measures, a specific delirium risk profile will be computed for each patient.~     Finally, the association of this delirium risk profile with CAM-ICU questionnaire as a gold~     standard will be assessed.~   "
61033|NCT02258373|"~     The primary objective of the study is to determine whether the routine use of Continuous~     Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and~     effective as CGM used as an adjunct to BGM.~   "
61034|NCT02258360|"~     This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48,~     ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic~     hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac~     arrest.~      The overall aim of this sub-study is to examine the hemostasis in patients resuscitated~     after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia~      Our specific aims are:~        -  To investigate the whole blood coagulation using the rotational thromboelastometry.~        -  To investigate the function of platelets~   "
61035|NCT02258347|"~     Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid~     nodules.~   "
61036|NCT02258334|"~     The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015~     formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65~     years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®~     High-Dose vaccines in adults ≥ 65 years of age.~      Objectives:~        -  To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and~          Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the~          2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in~          adults ≥ 65 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent~          and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the~          immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone~          ®High-Dose vaccines in adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®~          Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group~          with the historical requirements of the Committee for Human Medicinal Products (CHMP)~          Note for Guidance (NfG) CPMP/BWP/214/96.~   "
61037|NCT02258321|"~     This study will compare the blood levels of PPI-668 resulting from two different~     formulations - the current capsule and a new tablet, T003.~   "
61038|NCT02258308|"~     Asthmatic children age 3-17 from low income households in King County are randomly assigned~     into a community health worker (CHW) intervention group and a control group. The~     intervention is in-home education and support related to asthma self-management. The main~     outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life~     score, and health care utilization for asthma measured at baseline and 12 months after~     baseline enrollment.~   "
61056|NCT02258061|"~     The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known.~     Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve~     function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).~   "
61042|NCT02258256|"~     The purpose of the study is to help make a lower cost automatic blood pressure monitor~     device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic~     blood pressure monitoring is limited or not available. The study will compare this low cost~     device to a commercially available system used for pre-eclamptic women in many United States~     hospitals that the investigators will be bringing to Malawi as a part of this study.~      The team hopes to show that this lower cost blood pressure machine works well and can help~     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse~     to use.~      20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen~     Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the~     subject and the commercially available cuff on the opposite arm. A trained research~     assistant and the nurse will record the blood pressure measurements and document any alarm~     indications made by each device. Blood pressure measurements will continue until monitoring~     is no longer clinically prescribed.~      The results of this study will help researchers understand the performance and usability of~     this device in Malawi and help decide if any design changes are needed.~   "
61043|NCT02258243|"~     This pilot randomized phase II trial studies how well photodynamic therapy using blue light~     or red light works in treating basal cell cancer (carcinoma) in patients with a genetic~     condition that causes unusual facial features and disorders of the skin, bones, nervous~     system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic~     therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor~     cells and when exposed to an intensive light source (blue light or red light) become active~     and may kill the cells. It is not yet known whether photodynamic therapy is more effective~     with blue light or red light in treating basal cell carcinoma.~   "
61044|NCT02258230|"~     Compare operative times and complications of sacral colpopexy and paravaginal repair between~     two-dimensional and three-dimensional laparoscopic systems.~   "
61045|NCT02258217|"~     Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)~   "
61046|NCT02258204|"~     KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to~     determine if co-administration of ketamine with recombinant of tissue type plasminogen~     activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered~     with placebo, decreases cerebral infarction growth in diffusion weighted imaging between~     admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen~     within 4.5 h of onset with middle cerebral artery or distal internal carotid artery~     occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to~     endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have~     80% power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a~     two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be~     enrolled.~   "
61047|NCT02258191|"~     Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive~     ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.~      Multicentric Randomized Controlled Trial~      Primary Objective:~      To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term~     treatment efficacy and patient compliance~      Secondary Objectives:~      To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To~     carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with~     NIV~   "
61048|NCT02258178|"~     The goal of the registry is to develop a better understanding of the safety of Flucelvax in~     women and their offspring who were exposed to the vaccine during pregnancy~   "
61049|NCT02258165|"~     This study will be the first prospective study enrolling consecutive patients with advanced~     ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in~     this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal~     involvement. This study will also answer a number of other stil unanswered questions: the~     impact of gating and the impact of gated PET on clinical management of patients with~     advanced ovarian cancer. This study also individualises patients' treatment to allow~     patients who may benefit most form optimal surgical cytoreduction and those who are better~     treated by neoadjuvant~   "
61050|NCT02258152|"~     The purpose of this study placebo-controlled, randomized, double-blind study is to assess~     the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD)~     already treated with a stable dose of a cholinesterase inhibitor.~   "
61051|NCT02258126|"~     The objective of the present study is to evaluate the effect of 6 months exercise~     intervention program on hepatic fat fraction in overweight children.~      Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control~     (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise,~     comprising warm-up and skill development. The control group will attend a healthy lifestyle~     education program (2 days/month) and the intervention group an exercise (3 days/week) and~     healthy lifestyle education (2 days/month) combined program. Before and after the~     intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk~     factors will be measured. Furthermore, dietary habits and physical activity, blood pressure~     and pubertal development will be evaluated before and after the intervention.~   "
61052|NCT02258113|"~     The aim of this study is to measure visual acuity and contrast sensitivity using a novel~     reaction-time based visual field device Ocusweep compared to widely used methods. Addition~     to that. the aim is to validate a novel perimetry method (Visual Search Test, VST) which is~     based on reaction times in visual decision-making task, where the subject is allowed to move~     eyes and where the fixation is verified by the subject himself in contrast to standard~     automatic perimetry (SAP) where prolonged stationary fixation and external fixation~     monitoring apparatus is required. using a novel reaction-time based visual field device~     Ocusweep compared to generally used SAP methods. Those tests will be done for healthy~     volunteers and for persons with diagnosed eye or brain disease.~   "
61053|NCT02258100|"~     To date the effect of AIMS on medical interventions has not been studied. We seek to~     retrospectively evaluate paper and electronic anesthesia records among a single surgical~     population (esophageal surgery) to ascertain any differences that may exist between cohorts~     with regards to chart completion, anesthetic management and medical care.~   "
61089|NCT02257619|"~     The purpose of this study is to determine if INCB039110, in combination with docetaxel, is~     safe and effective in the treatment of non-small cell lung cancer (NSCLC).~   "
61057|NCT02258048|"~     This is a prospective study designed to examine the role of transient elastography as a~     predictor of clinical decompensation in patients with early cirrhosis. The study objective~     is to determine if changes in measurements of liver stiffness with transient elastography~     can identify patients that will have a more rapid progression of cirrhosis and the~     development of clinical decompensation. The target population is patients with early stage,~     well-compensated cirrhosis.~      Participants of this study will be asked to complete the following procedures: read and sign~     the informed consent, medical records review (complete medical history, physical~     examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo~     transient elastography to measure liver stiffness every three months until the development~     of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic~     encephalopathy) for up to 2 years.~   "
61058|NCT02258035|"~     The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human~     volunteers and use these purified proteins to cross-validate existing or novel assays for~     this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc~     for different vitamin D metabolites.~   "
61059|NCT02258022|"~     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide.~     The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value.~     This study is seeking to determine if the breath delta value of adults with trauma is an~     early indicator of the onset of infection that may lead to sepsis.~   "
61060|NCT02258009|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.~   "
61061|NCT02257996|"~     Objective: To evaluate the effectiveness of online systematic brief psychodynamic~     psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.~      Design: Randomized controlled trial. Single blind.~      Setting: Internet users in the community, in São Paulo, Brazil.~      Participants: Thirty-two adults will be randomly allocated to a group will receive online~     systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).~      Method: Systematic adaptative diagnosis system will be applied in both groups at~     pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of~     the adaptative diagnosis evolution between groups.~      Primary Outcomes: The subjects treated with online brief systematic psychodynamic~     psychotherapy will present an increase in their adaptative efficacy measured by systematic~     adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting~     their initial and final adaptative diagnostics.~   "
61062|NCT02257983|"~     If effective, administration of EPI-743 should have protective effects against temporary~     noise-induced hearing loss.~   "
61063|NCT02257970|"~     This study compares the effectiveness of a study drug versus placebo in the treatment of~     lymphedema to the untreated condition, in the same individual..~   "
61064|NCT02257957|"~     Dry eye is a chronic condition that decreases function and affect visual function with~     severe discapacity until now treatments are based in artificial eye drops. Platelet rich~     plasma has emerged as a strategy for cellular restoration, the purpose of this study is to~     evaluate their effects in lacrimal production and safety of this intervention in patients~     with severe dry eye.~   "
61065|NCT02257944|"~     The purpose of the study is to develop a program to help people to lower their chances of~     being violently injured again.~   "
61066|NCT02257931|"~     A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% -~     42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of~     Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more~     antibiotic classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR)~     strain (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC~     11). These resistant bacteria may be associated with increased mortality and have limited~     treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the~     currently best empirical coverage and to control the growing resistance, knowledge of trends~     in antibiotic susceptibility, as well as risk factors is essential. For this reason we~     propose to perform non-interventional prospective multicentre study in EBMT centres.~   "
61067|NCT02257918|"~     This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male~     and female subjects, between the ages of 18 and 55, who are in good health and meet all~     eligibility criteria. The study is designed to assess the safety and efficacy of an~     antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to~     adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.~     Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of~     AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name~     is also known as ETX0914.~   "
61068|NCT02257905|"~     Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor~     prognosis. Rarity of disease has precluded performance of randomized controlled trials~     comparing various possible treatment modalities. In general, treatment of AL amyloidosis has~     been adapted from myeloma (MM) therapy. There is large experience with allo SCT in MM. Based~     on small series of patients and case reports allogeneic transplant has emerged as~     potentially effective. However, more formal proof of concept of using allogeneic~     hematopoietic transplantation for treatment of AL Amyloidosis is lacking.~      Therefore, given the limitations of conventionally collected registry data (dubious~     follow-up information and extreme heterogeneity), we developed the: EBMT non-interventional~     prospective study on allogeneic transplantation in AL Amyloidosis which means that~     transplant centers that already do perform allogeneic transplants for AL Amyloidosis will be~     encouraged to register their patients with AL Amyloidosis very timely with the EBMT,~     followed by mandatory submission of EBMT MedB and follow-up forms. The diagnosis of AL~     Amyloidosis would be based on uniform criteria. All EBMT centres performing allogeneic~     transplants for Amyloidosis will be invited to participate in this study and centres will be~     asked to report all AL Amyloidosis cases referred for transplantation using a simple~     registration form and then to submit Amyloidosis MED B forms for each transplanted patient~     and follow-up forms as necessary. In conclusion, it should be possible to largely improve~     the usual quality of registry-based data and to generate scientifically sound knowledge on~     HSCT in an orphan disease such as AL Amyloidosis.~   "
61069|NCT02257892|"~     Background:~      - The immune system helps the body fight infection and disease. People with immune system~     problems can get infections, blood disorders, and other health problems. Researchers want to~     learn more about the immune system, like what causes it to not work properly.~      Objectives:~      - To evaluate people with certain types of immune system disorders.~      Eligibility:~      - Adults and children with an immune disorder or symptoms of one, and their relatives. Some~     disorders are not included in this study.~      Design:~        -  Researchers will review participants medical records.~        -  Participants may mail in a blood or saliva sample, or be evaluated at the clinic. At~          the clinic, they may have a medical history, physical exam, blood tests, and imaging~          scans (with dye given through a needle in the arm). They may have genetic testing done~          on a sample of blood, saliva, hair, or nail clipping.~        -  Participants may choose to have a skin biopsy. Up to 2 skin samples will be taken from~          their arm, back, or other area. A biopsy punch is inserted into the skin and rotated. A~          small circle of skin is removed.~        -  Participants 10 and older may also choose to have leukapheresis. Blood is taken through~          a needle in one arm. It passes through a machine that separates the white blood cells.~          The rest of the blood is returned by needle in the other arm.~        -  Researchers may recommend medicines, but no treatments are being studied.~        -  Participants may be invited to return for visits over several years. At those visits,~          they may repeat some or all of the above tests. Or they may mail in blood or other~          samples. They may also send medical records.~   "
61070|NCT02257879|"~     Background:~      - Drinking grapefruit juice changes how long it takes some medicines to be broken down in~     the body. Researchers have found that a substance in grapefruit juice called DHB contributes~     to this effect. Some dietary supplements contain DHB and claim to increase the absorption of~     any and all supplements, medicine or any other drug. But these usually contain a lot more~     DHB than a glass of grapefruit juice. Researchers want to study the effects of grapefruit~     juice and supplements with DHB.~      Objective:~      - To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice~     affects how long it takes a person s body to break down medicines.~      Eligibility:~      - Healthy volunteers ages 18 - 60.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will have 3 treatment visits. Participants cannot drive themselves home~          from the visits. Each visit lasts about 13.5 hours and includes:~        -  Questions about medications and participant s health.~        -  Vital signs taken.~        -  A finger probe to measure oxygen.~        -  Blood and urine sampling throughout the visit.~        -  An IV line inserted into an arm vein. It will stay there throughout the visit.~        -  Study treatments:~        -  Midazolam hydrochloride a syrup given to make people sleepy.~        -  Loperamide a tablet for treating diarrhea.~        -  1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one~          will be given at each treatment visit.~        -  One week before each visit, participants cannot have certain fruits and juices. They~          must fast the night before each visit.~        -  For the 3 days after each visit, participants will return to the clinic 4 times. Their~          vital signs will be checked and blood will be drawn.~   "
61071|NCT02257866|"~     Background:~      - Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can~     cause many medical problems. Few tests can diagnose the disease, and none can reliably~     predict a relapse. Researchers want to study people s genes and follow people over time to~     see how the disease affects them.~      Objective:~      - To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can~     help identify people with vasculitis and predict what will happen to them over time.~      Eligibility:~        -  People age 5 and older who have or are thought to have vasculitis, or are related to~          someone with it.~        -  Healthy volunteers.~      Design:~        -  Participants will be evaluated by a doctor who has expertise caring for patients with~          vasculitis.~        -  Participants will give a blood sample. Some will give a urine sample.~        -  Some participants may have brushings or biopsies taken from the inside lining of the~          nose.~        -  Images of participants blood vessels may be taken using scans. For some scans,~          participants will lie on a table that moves in and out of a cylinder that takes~          pictures. For some scans, a contrast agent may be injected into an arm vein. Other~          scans may use a radioactive form of sugar. Healthy minors will not have scans.~        -  Some participants will answer questionnaires. - Some participants will have their tests~          done at NIH. Others will have their doctor take the blood, saliva, or cheek swab~          samples and send them to NIH.~        -  Some participants will have one visit lasting 1 2 (but sometimes up to 4) days. Some~          participants may have follow-up visits every 3 6 months, indefinitely.~   "
61072|NCT02257853|"~     Background:~      - People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they~     recover. Being a caregiver can be stressful to the body and mind. Researchers want to find~     ways to reduce this stress.~      Objective:~      - To see how a stress reduction intervention affects the stress levels and health of an HSCT~     caregiver.~      Eligibility:~      - Adults age 18 and older who plan to be an active caregiver for a person having their first~     allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be~     caring for the person from just before admission for the HSCT until at least 6 weeks after.~      Design:~        -  Participants will be put in either the intervention group or the control group.~        -  All participants will get the usual caregiver education given to all patients and~          caregivers having a stem cell transplant at the NIH Clinical Center.~        -  All participants will have 2 study visits. They will give blood samples. They will have~          health assessments and brief physical exams. They will fill out study questionnaires~          and have an exit interview.~        -  The intervention group will get an MP3 player. It will have an audio file with a stress~          reduction intervention on it. Participants will do this intervention daily. It takes 20~          minutes. They will do gentle stretches and breathing exercises. They will get a diary~          to track their practice.~        -  The intervention group also will have follow-up phone calls 2 and 4 weeks after their~          first clinic visit.~        -  The person getting the HSCT will not be actively involved in the study.~        -  The study will last about 2 months.~   "
61073|NCT02257827|"~     There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT)~     versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control.~     Data from retrospective studies show that IMRT reduces the risk of severe late~     complications. More recently, the results from the RTOG 0126 study have also confirmed the~     benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional~     dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT~     using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.~   "
61156|NCT02256722|"~     Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg~     ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol~     and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose~     of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol~   "
61074|NCT02257814|"~     The purpose of this study was to deepen the evidence base for interventions that support the~     social-emotional skills that underlie children's engagement and attention to learning tasks~     by schools (learning behaviors) and their social interactions with teachers and peers~     (social behaviors). The study tested three theoretically-distinct approaches to enhancing~     children's social-emotional development, along with a comprehensive coaching and training~     model, on a large scale within the Head Start system.~   "
61075|NCT02257801|"~     The purpose of this study is to study effects of a four months lutein supplementation (in~     form of a lutein fortified nutritional beverage) on general learning and memory performance~     as well as on acute stress-induced changes in learning and memory performance in chronically~     stressed males and females using 2 different lutein doses in comparison to a placebo.~   "
61076|NCT02257788|"~     PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female~     adult subjects infected with CCR5-tropic HIV-1.~   "
61077|NCT02257775|"~     The objective of this study is to apply Whole-body DW imaging alongside the routine~     management of patients requiring systemic therapy for metastatic breast cancer to compare~     the time to progression of individual liver metastases within and between patients following~     stable disease or partial response to palliative systemic therapy for breast cancer.~   "
61078|NCT02257762|"~     The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17~     months in preventing growth faltering and improving micronutrient status. The impact of~     product will be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group~     consuming an unsupplemented diet, which is usually borbor at an early age, and thereafter,~     family foods.~   "
61079|NCT02257749|"~     The purpose of this randomized control trial study is to determine if an active~     rehabilitation (low intensity exercise program) in combination with a comprehensive~     education intervention (standard care) is more effective than the comprehensive education~     intervention alone in reducing post-concussion symptoms and improving participation in daily~     activities in youth who have persistent post-concussion symptoms.~   "
61080|NCT02257736|"~     The purpose of this study is to compare the radiographic progression-free survival (rPFS) of~     apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone~     (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any~     chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate~     cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of~     sperm]).~   "
61081|NCT02257723|"~     This study investigates the effect of hospital-based intensive non-surgical treatment in~     musculoskeletal patients admitted to an integrated hospital that offers both complementary~     and alternative medicine (CAM) and conventional medicine treatment.~   "
61082|NCT02257710|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and~     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in an all-comers patient population in daily clinical practice.~   "
61083|NCT02257697|"~     To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is~     non-inferior to that of standard therapy CTX through analyzing overall remission rate after~     treatment.~   "
61084|NCT02257684|"~     The purpose of this study is to evaluate the effectiveness,safety, and dosage of~     pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic~     Lymphoma (LBL).~   "
61085|NCT02257671|"~     The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood,~     sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study.~     400 healthy women will be randomized to OC or placebo for a period of three months. Before~     and at the end of treatment, mood and sexuality will be assessed by validated instruments.~     At the end of treatment, each woman will participate in behavioral experiments testing~     self-confidence, risk taking and altruism. The current project could fill the gap of~     ignorance about causal effects of OCs on mood, sexuality and behavior. The results might~     improve current practice as regards information about OCs, choice of hormonal contraceptive,~     regimen and duration of use. As a consequence, this could lead to reduced discontinuation~     rate, fewer unintended pregnancies and abortions. The project will contribute to an overall~     improvement in women's reproductive health.~   "
61086|NCT02257658|"~     This pilot study will investigate the feasibility of conducting a large, randomized trial~     comparing a structural intervention to contingency management to reduce incident syphilis~     infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have~     had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive~     either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.~     The investigators will : 1) measure adherence to study visits in both arms; 2) measure~     adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study~     participants and 4) to the extent possible in a small pilot study of short duration, compare~     effectiveness of doxycycline with that of a monetary incentive for remaining STI free.~   "
61087|NCT02257645|"~     A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active~     primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus~     influenza type B in infants.~   "
61088|NCT02257632|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF protein levels in treatment naïve wAMD patients in a~     detailed time course.~   "
61090|NCT02257606|"~     With this randomised intervention study, the investigators want to investigate the training~     effect of an 8 week training regime, using a robot-assisted training system in persons with~     MS. Besides conventional therapy, study participants in the experimental group will train 3~     times per week during 30 minutes, using the haptic master. Research questions focus on the~     effects of additional robot assisted training on range of motion, movement quality and~     clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires~     and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16~     weeks of follow-~   "
61091|NCT02257593|"~     The purpose of this study was to evaluate whether birth weight is related to the demand for~     dietary protein in adult survivors of severe acute malnutrition (Kwashiorkor and Marasmus),~     and that leveraging of protein intake is associated with total energy intake and weight~     change in the survivors consuming foods with different percentages of energy as protein~     (PEP).~   "
61092|NCT02257580|"~     E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss~     and transfusion requirements after several orthopedic procedures. The aim of this~     prospective double-blind placebo-controlled randomized trial is to determine whether IV EACA~     reduces intra-operative calculated total blood loss in patients undergoing bilateral varus~     rotational osteotomy (VRO). This study will also investigate intraoperative cell saver~     utilization, transfusion of allogeneic blood, hospital length-of-stay (LOS), short term~     complications, and long-term outcomes.This study will provide Level I evidence and has the~     potential to improve outcomes in children undergoing this procedure.~   "
61093|NCT02257567|"~     This study is a multicenter, open-label study of polatuzumab vedotin administered by~     intravenous (IV) infusion in combination with standard doses of bendamustine (B) and~     rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular~     lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a~     Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18~     weeks for participants with DLBCL and 24 weeks for participants with FL.~   "
61094|NCT02257554|"~     The goals of this study are to assess concordance between the patient-surgeon pair regarding~     expectations of lumbar spine surgery.~   "
61095|NCT02257541|"~     The goal of a phase Ib clinical trial is to find the doses of drugs that are safe. Although~     BGJ398 has been given to patients safely on its own, it has never been given together with~     imatinib mesylate. In this study, we will test the safety of taking BGJ398 with imatinib~     mesylate. The investigators will learn this by closely checking for side effects that the~     patient may experience. Side effects can be seen in laboratory studies, on physical~     examination, or by asking the patient.Once a dose has been determined to be safe, a larger~     Phase II study will be done in patients with advanced GIST who have never received any prior~     treatments.~   "
61096|NCT02257528|"~     This phase II trial studies the side effects and how well nivolumab works in treating~     patients with cervical cancer that has grown, come back, or spread to other places in the~     body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by~     targeting certain cells.~   "
61097|NCT02257502|"~     After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50~     years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.~     This is a rare and severe disease, which can lead to blindness.~      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)~     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated~     in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not~     need as many injections as in AMD.~      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage~     regimen is designed to achieve maximum efficiency. The patients are followed on a monthly~     basis until 52 weeks. Intravitreal injections of aflibercept are initiated with a Treat &~     Extend (TAE) regimen until 20 weeks (3 mandatory injections with reinjection only in case of~     CNV activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection~     in case of CNV activity).~   "
61098|NCT02257489|"~     This study will evaluate the safety and tolerability of single and multiple doses of ACE-083~     as a local injection into selected skeletal muscles of healthy subjects. The study will also~     determine the amount of ACE-083 that reaches the systemic circulation following local~     administration. Additionally, the study will assess whether local administration into~     skeletal muscle results in an increase in the size and/or strength of the injected muscle.~   "
61099|NCT02257476|"~     The purpose of this study is to find the safest dose level of an approved drug, carfilzomib,~     in solid tumors when given over a different period of time than normally used. The study~     will also use markers in blood from routine blood draws to help check the levels of the~     drug. Lastly, the study will check how well this drug works with regards to keeping cancer~     cells from growing with the new time frame of delivery.~   "
61100|NCT02257463|"~     The aim is to study effectiveness of inspiratory muscle training as a part of exercise~     training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to~     general exercise training program in regard to respiratory muscle strength, dyspnea,~     exercise performance and quality of life.~   "
61101|NCT02257450|"~     This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult~     population.~   "
61102|NCT02257437|"~     The purpose of this trial is to evaluate the acceptability of the LNS to women and their~     children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor~     (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will~     be assessed through a sensory test for caregivers, and by measuring children's consumption.~   "
61103|NCT02257424|"~     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and~     preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral~     dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.~   "
61157|NCT02256709|"~     Safety, tolerability and pharmacokinetics (including comparisons of different formulations~     and investigation of food effect)~   "
61158|NCT02256696|"~     Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to~     first-line TB treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks~     of treatment. Funding Source - FDA OOPD~   "
61104|NCT02257411|"~     After institutional ethics board approval and written informed consent from parents, 197~     children scheduled for routine genitourinary operation and in whom a LMA was indicated for~     anesthesia were included in the study. The size of the LMA was determined by choosing the~     size that was best matched with the auricle of the children. The results were compared with~     the standard method recommended by the manufacturer's weight-related guidelines. The~     patients were classified in different groups depending on the PLMA sizes determined by both~     methods. A kappa coefficient evaluated the agreement between both techniques.~   "
61105|NCT02257398|"~     This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind~     crossover, single-dose study to evaluate the effects of a therapeutic (1000 milligram [mg])~     and supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400~     mg) and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter~     electrocardiograms (ECGs) in approximately 55 healthy volunteers.~      All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg,~     moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be~     used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo~     and GSK2140944 or placebo will be administered.~      Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report~     to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects~     will remain confined until check out procedures have been completed on Day 3 (5 days~     confinement in Period 1 and 4 days in the following 3 periods). There will be a washout of~     at least 7 days between doses. The follow-up visit will occur 7-10 days after the final~     dose. Total duration of the study (from screening to the follow-up visit) will be~     approximately 60 days.~   "
61106|NCT02257385|"~     This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to~     evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once~     daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol~     plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a~     treatment period of 12 weeks in participants with moderate to very severe Chronic~     Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that~     UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD~     participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER®~     inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced~     expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the~     eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior~     to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and~     week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study~     participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK~     group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH~     & Co. KG. BREEZHALER is a registered trademark of Novartis AG.~   "
61107|NCT02257372|"~     This is a multicenter, randomized, double-blind, parallel-group study to evaluate the~     efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered~     once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist~     (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a~     treatment period of 12 weeks in subjects with COPD. This study is designed to investigate~     the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the~     treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone~     Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as~     AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg~     twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12~     mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol~     metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed~     (prn).~      Subjects who meet the eligibility criteria will be randomly assigned to one of the following~     blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and~     Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be~     randomized in order to complete at least 206 evaluable subjects. The total duration of the~     study will be approximately 14 weeks for each subject.~      UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a~     monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of~     COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment~     of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United~     States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under~     regulatory review in other countries.~      SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies.~     Other company or product names mentioned herein may be the property of their respective~     owners.~   "
61108|NCT02257359|"~     Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced~     implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open~     label study designed to assess the safety, tolerability and pharmacokinetics of additional~     repeat doses of epelsiban in healthy females, and will be the first dosing experience of~     greater than 200 milligram (mg) as a single dose with this compound. Data from this study~     will inform the selection of doses of epelsiban to be used in future clinical studies. This~     study will be composed of 3 periods: Screening, Treatment, and Follow-up. The total duration~     that a subject involved in the study will be up to 6 weeks. At least 2 cohorts of subjects~     will be enrolled in this study and cohorts will be conducted sequentially. Additional~     cohorts will be enrolled if determined necessary. A sufficient number of subjects will be~     screened for the study to obtain approximately 6 evaluable subjects per cohort.~   "
61109|NCT02257346|"~     When given intravenously, the local anesthetic lidocaine has been shown to decrease the~     amount of pain medication patients require when recovering from several types of surgeries.~     Cesarean delivery is a very common surgery in the United States, effecting more than 1~     million women each year. The investigators hypothesize that lidocaine, given during and~     immediately after a patient undergoes a cesarean section, will help improve a mother's~     overall recovery experience, as well as positively influence bonding with her new baby.~   "
61122|NCT02257177|"~     This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single~     centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the~     safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male~     subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled,~     multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of~     TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.~   "
61251|NCT02255461|"~     This phase I trial studies the side effects and best dose of palbociclib isethionate in~     treating younger patients with central nervous system tumors that have grown, come back, or~     not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
61110|NCT02257333|"~     The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic~     retinopathy, and is a common cause of unilateral visual loss. The risk factors that~     predispose to RVO are many and are generally the same as those found in vascular alterations~     involving other parts of the body, as in the case of stroke or coronary heart disease.~     Several authors have attempted to determine whether the pathogenesis of RVO can be of~     arterial type, considering the disease as consequent to atherosclerosis, rather than~     resulting from venous disease. Although less frequent than the other diseases RVO affects~     considerably on health care costs. Direct medical costs showed that in one year a patient~     with this disease has a higher than average cost for a patient with hypertension or~     glaucoma. Knowing the prevalence of the disease in Italy and identify modifiable risk~     factors, recognizing additional risk factors related to gender, genetic predisposition and~     especially the social-economic and cultural background in the pathogenesis of RVO, are the~     objectives that led to the planning of this study. In order to assess the prevalence of the~     disease and the current clinical practice we aim to create an online register between~     Italian specialist centers (ophthalmic emergency care and thrombosis centers) with immediate~     portability and usability of the data.~   "
61111|NCT02257320|"~     The study is an open-label, prospective, single-center, non-randomized feasibility study of~     the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the~     impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events~     and incidence of migraines and headache in subjects diagnosed with sleep bruxism.~   "
61112|NCT02257307|"~     Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a~     multi-center observational study will focus on feasibility, and relative cost-effectiveness~     of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of~     at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical~     Center.~   "
61113|NCT02257294|"~     The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg~     and 20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in~     reducing MVO and its consequences in high risk patients with STEMI.~   "
61114|NCT02257281|"~     The purposes of study are to investigate the effect of therapeutic ultrasound for the~     inflammatory skin repair and whether the tissue repair under ultrasound treament is depend~     on different inflammatory level.~   "
61115|NCT02257268|"~     The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical~     activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco-~     Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive~     medication and classified as non-physically active, will be selected and randomly~     distributed into two groups: a change behavior group (CBG) and control group (CG). The CBG~     will participate of a change behavior program, entitled VAMOS - Active Life Improving~     Health, for 12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes.~     In each weekly meeting, will be presented and discussed guidelines and strategies for~     practical physical activities in different fields and for adoption of a healthy diet in~     order that the level of physical activity and eating quality improve. The program will be~     evaluated by effectiveness, implementation and maintenance (initial and individual level)~     dimensions of RE-AIM framework. The effectiveness will be assessed from anthropometric~     measurements, body composition, eating habits, physical activity level, stages of~     self-change, self-efficacy, social support, quality of life and assessment of cardiovascular~     function at rest (clinic and home blood pressure, arterial stiffness, blood flow and~     flow-mediated dilation, heart rate and heart rate variability) before and after 12 weeks of~     intervention. The implementation will be assessed by identifying the extent to which the~     program will be conducted as planned. The maintenance, initial and at individual level, will~     be estimated from revaluations of all outcomes, as measured before and after the~     intervention, three months after the end of the program. For data analysis, in addition to~     descriptive statistics, two-way ANOVA for mixed models wil be applied for for within and~     between groups comparison, if the premises of this test are met. The level of significance~     that will be adopted is P<0.05. All analyzes will be done at SPSS statistical package,~     version 17.0.~   "
61116|NCT02257255|"~     Cesarean section is the most performed abdominal surgery in women, worldwide. The World~     Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery.~     However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in~     hospitals and private clinics.~      The most used technique of cesarean section is the known as Pfannenstiel or Classical~     technique. In 1996, a new technique was described, called Misgav Ladach or minimally~     invasive technique.~      Several studies have show that the minimally invasive technique is faster and promotes lower~     costs and less intraoperative bleeding. There is no current evidence that this technique is~     less painful.~      This study aims to compare the postoperative pain in both techniques,by means of two pain~     scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale,~     the McGill Scale.~   "
61117|NCT02257242|"~     This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the~     standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell~     lymphoma. This is a dose-escalation study.~   "
61118|NCT02257229|"~     All patients who meet inclusion criteria and who agree to participate in the study will be~     evaluated for classification of clubfoot reducibility (Dimeglio 1995), which characterizes~     the four components of clubfoot deformity including equinus, heel varus, calcaneopedal~     rotation, and forefoot adduction.~      Patients will be allowed to select treatment with either the daily massage and taping~     technique or the Ponseti casting technique. It is not practical or feasible to randomize~     patients as transportation and scheduling, as well as family preference and willingness to~     participate, are primary factors in the French physical therapy method of massage/taping.~      Once treatment intervention has been determined, patients will be enrolled into the surgical~     or one of two non surgical arms (French physical therapy or Ponseti casting) of the study.~     Research participation entails the retrospective and prospective review of data collected~     through standard medical care.~      All patients who undergo clubfoot treatment, may have the following evaluations:~      Standard-of-care~        -  Clinical exams- will be conducted at the initial visit, 4 weeks, 8 weeks, 12 to 14~          weeks, 6 months, and 9 months following treatment. Also at 1 year, 18 months, 2 years,~          3 years, 4 years, 5 years, and 10 years of age and at skeletal maturity.~        -  Radiographs- standing AP and laterals of both feet may be taken at 18 months, 4 years~          of age, and at skeletal maturity (for a total of 12 possible radiographs over the span~          of the study).~      Investigational~        -  Questionnaires - at age 4, age 10, and at skeletal maturity: patient/parent baseline~          assessment.~        -  Radiographs- standing AP and laterals of both feet (for a total of 4 radiographs) will~          be taken for all adult participants.~        -  Movement Science Lab- at 2, 5, 10 years of age and at skeletal maturity. This testing~          may include walking with reflective markers and electrodes attached with tape to~          his/her legs, walking across a pressure plate, video, digital pictures, wearing a step~          monitor, strength testing, and an agility test.~        -  Physical therapy - at 4 years of age: developmental motor scale; at 10 years of age and~          at skeletal maturity: motor proficiency assessment.~        -  Brace compliance - patients will have a temperature logger placed in the shoes of the~          Dennis-Browne Bar at the initial fitting visit in the Orthotics department. At every~          subsequent clinic follow-up visit the Orthotist downloads the time/temperature data~          onto a laptop from the sensor reader (A piece of computer hardware which the sensor~          clips into and is attached to the laptop via the USB port). The Orthotist will then~          reset the temperature logger discs in order to monitor the next period of brace wear.~      The following additional evaluations may be conducted on the patients who also have surgical~     treatment of clubfoot:~      Standard-of-care • Clinical exams and radiographs will be conducted as is required by the~     surgeon. No additional radiographs are needed for investigational purposes.~      Investigational~      • Movement Science Lab testing may be done before surgery, 1, 2,5, and 10 years following~     surgery, and at skeletal maturity.~      In addition, relevant retrospective data from your child's medical chart including clinical~     history, radiographs, and data collected in the Movement Science lab, may be used.~   "
61119|NCT02257216|"~     The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.~   "
61120|NCT02257203|"~     This is a pilot randomized clinical trial of a brief educational intervention offered in~     primary care for Latino parents that promotes healthy beverage consumption by infants and~     toddlers. The control group will receive an educational intervention that promotes parents~     reading to children.~   "
61121|NCT02257190|"~     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and~     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The~     reason IW is superior is unknown.~      This study will look into whether it is the larger peak intensity during IW or if it is the~     alternating exercise pattern that is responsible for the larger improvements seen.~      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled~     study, where each subject will undergo three trials. Trials will be identical except the~     following interventions:~        1. One hour of rest (Con)~        2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of~          slow walking; IW3)~        3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1~          min of slow walking; IW1).~      After the interventions subjects will undergo a standardized mixed meal tolerance test, with~     consecutive measurements of blood glucose, insulin and c-peptide.~   "
61141|NCT02256917|"~     The rationale of this study is to further fine-tune and individualize prophylactic treatment~     of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above~     1% between doses. Because trough FVIII levels are likely to be important predictors of the~     efficacy of prophylaxis, the focus of this study is on PK data.~   "
61123|NCT02257164|"~     Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery.~     The post-operative pain of this surgery is managed according to recommendation. In the~     majority of case, femoral nerve block is performed. The femoral nerve block can cause~     paralysis of the quadriceps more or less complete that no allowing a good quadriceps~     locking. This locking is indispensable to avoid post-operative flexima and to ensure~     stabilization of the knee during walking.~      In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most~     cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain~     requires powerful analgesics with their adverse events.~      Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure~     in the same time optimal analgesia and optimal quadriceps locking. The main objective of the~     investigators study is to compare two analgesia techniques : femoral nerve block vs intra~     articular injection and obturator nerve block in surgery of the anterior cruciate ligament~     of the knee~   "
61124|NCT02257151|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement~     of BMS-986142 in healthy subjects.~   "
61125|NCT02257138|"~     This clinical research study is made up of 2 parts: Phase 1 and Phase 2.~      The goal of Phase 1 of this study is to find the highest tolerable dose of the combination~     of decitabine and ruxolitinib that can be given to patients with AML.~      The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to~     control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML).~      The safety of the drug combination will be studied in both phases.~   "
61126|NCT02257125|"~     This study investigates the use of motivating/rewarding features in a computer based arm~     rehabilitation program. Half of the subjects will take part, besides receiving standard~     therapy, in a computer based program delivering a game like scenario with visual effects and~     monetary rewards in case of successful level completion, while the other half will take part~     in a similar program without visual effects or the possibility to earn money.~   "
61127|NCT02257112|"~     Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation~     during an acute testing procedure.~   "
61128|NCT02257099|"~     The primary hypothesis is that measures of patellofemoral alignment obtained from the~     investigational cone beam CT scanner will be reduced, but still correlated to those obtained~     from the conventional CT scan.~   "
61129|NCT02257073|"~     To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid~     arthritis~   "
61130|NCT02257060|"~     The Linear II study is a prospective, single center, non-randomized, interventional~     feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear~     Type Ablation Catheter and the performance of the product when used for the treatment of~     symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.~   "
61131|NCT02257047|"~     To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with~     rheumatoid arthritis~   "
61132|NCT02257034|"~     To evaluate the effect of Tai chi on Fibromyalgia~   "
61133|NCT02257021|"~     To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of~     tipranavir/r on BILR 355 BS pharmacokinetics~   "
61134|NCT02257008|"~     Assessment of the effect of different boosting agents on pharmacokinetics of a single dose~     of BILR 355 BS dissolved in PEG 400~   "
61135|NCT02256995|"~     A prospective observational study to test the feasibility of smartphone enabled uChek~     urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in~     urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess~     attitudes of clinicians towards uChek as a new technology for urinalysis.~   "
61136|NCT02256982|"~     This research study is evaluating the use of radiation therapy in combination with~     chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of~     gastrointestinal cancer.~   "
61137|NCT02256969|"~     In this research study, the investigators are looking at the effects of Meibomian Gland~     Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have~     already tried traditional management with no success in resolving their clinical signs (as~     seen by their ophthalmologist) or their symptoms.~      The investigators are also evaluating the effects of using two (2) post-procedural~     medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after~     the MGP procedure has an effect on its outcome.~   "
61138|NCT02256956|"~     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain~     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies~     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic~     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,~     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not~     known to which extent metabolizer classes determine pain outcomes or side-effects. As only~     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic~     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may~     contribute to the patients quality of life. The aim of this study is to determine the~     influence of cytochrome variants on experimental pain, drug related side-effects and finally~     identification of active metabolites.~   "
61139|NCT02256943|"~     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain~     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies~     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic~     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,~     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not~     known to which extent metabolizer classes determine pain outcomes or side-effects. As only~     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic~     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may~     contribute to the patients quality of life. The aim of this study is to determine the~     influence of cytochrome variants on experimental pain, drug related side-effects and finally~     identification of active metabolites.~   "
61140|NCT02256930|"~     This is a single center, randomized, controlled, within subject comparison, multiple dose~     study to determine the sensitization potential of M518101 on normal skin under occlusive~     patch condition.~   "
61142|NCT02256904|"~     Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial~     components perpendicular to their mechanical axis. Therefore, current surgical technique~     does not replicate natural knee anatomy and biomechanics. An alternative alignment method~     that attempts to replicate the kinematics of the knee is  kinematic alignment . The~     principle behind kinematic alignment is placement of the TKA components so that the~     orthogonal 3-D orientation of the 3 axes that describe normal knee kinematics is restored to~     that of the prearthritic knee. Theoretical benefits of kinematic alignment include less~     ligamentous release to balance the knee intra-operatively, more rapid recovery, better range~     of motion (ROM), less post-operative pain, better knee biomechanics, and improved patient~     satisfaction. However, a major concern is that there are no mid- or long-term data on~     implant survivorship (absence of loosening) in TKA based on anatomical implantation. The~     investigators propose to compare the clinical results of TKA implanted with mechanical~     alignment (standard practice) to kinematic alignment, in a double-blind, randomized trial.~   "
61143|NCT02256891|"~     This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of~     patients treated with arthroscopic rotator cuff repair using one of two techniques. One~     technique used is the standard double row repairs utilizing medial and laterally based~     anchor fixation and the other technique is the standard double row repairs utilizing medial~     and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It~     is hypothesized that patients undergoing the surgery with the PRFM will report a higher~     quality of life than the patients that do not receive this treatment.~   "
61144|NCT02256878|"~     The objective of the study was evaluate that there is no clinically relevant interaction~     between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite~     BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in~     an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline~     were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after~     repeated doses of BIRT 2584 XX near steady state~   "
61145|NCT02256865|"~     The purpose of this study is to study the effects of sleep restriction on the production of~     two hormones, cortisol and testosterone. The investigators aim to show that changing these~     hormones leads to insulin resistance, which is an important cause of type 2 diabetes~     mellitus. The investigators may also study the effect of sleep restriction on your food~     intake and cravings, mood, inflammation, metabolism (including bone), and other hormones.~     Inflammation is your body's response to stress and injury. Bone metabolism is a process of~     how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are~     natural substances (materials) that are produced in the body and that influences (effects)~     the way the body grows or develops.~   "
61146|NCT02256852|"~     The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism~     of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive~     or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.~   "
61147|NCT02256839|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
61148|NCT02256826|"~     To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR~     355 BS~   "
61149|NCT02256813|"~     The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on~     the Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.~      The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral~     omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and~     intravenous midazolam (for hepatic CYP3A)~   "
61150|NCT02256800|"~     Metastatic diseases were found in 20-25% of patients with initial diagnosis of colorectal~     cancer and developed in up to 50% of patients. Owing to limited post-treatment response of~     5-fluorouracil (5-FU) combined with leucovorin (LV) obtained in mCRC (metastatic colorectal~     cancer) patients, other therapeutic agents with different mechanisms were considered, such~     as irinotecan, a potent inhibitor of topoisomerase I, which is involved in the unwinding of~     DNA during replication. Bevacizumab is a humanized monoclonal antibody that inhibits tumor~     angiogenesis by blocking vascular endothelial growth factor (VEGF) and was the first~     antiangiogenic agent approved for the treatment of cancer.~      Infusional fluorouracil/leucovorin plus irinotecan-based regimen (FOLFIRI) with bevacizumab~     has been widely used as first-line treatment for patients with metastatic colorectal cancer~     (mCRC). Recently, the investigators have shown that prospective analysis of uridine~     diphosphate glucuronosyl transferase 1A1 (UGT1A1) genotyping for irinotecan dose escalation~     (FOLFIRI regimen) with combination of bevacizumab biweekly as the first-line setting in mCRC~     patients (ASCO Abstract #491 - 2013 Gastrointestinal Cancers Symposium).~      In this study, the investigators will enroll approximately 320 mCRC patients (It was~     considered that an increase of response rate of 15% compared to conventional irinotecan dose~     of 180 mg/m2, and these were chosen as parameters with which to calculate the study power.~     Initial power calculation was suggested that a minimum of 140 patients in each group would~     be required to achieve statistical significance with a power of 80% at the 5% significance~     level. It is estimated that about 10% of 320 mCRC patients fail to complete the study). For~     these enrolled patients, the investigators will randomize and divide these patients into two~     groups: control group and study group. Control group includes mCRC patients who will receive~     the conventional regimen of FOLFIRI plus bevacizumab. Otherwise, patients in the study group~     will have genotyping of UGT1A1 before therapy, and dose escalating of irinotecan will depend~     on results of genotyping.~   "
61151|NCT02256787|"~     The objective of the current study was to investigate the safety, tolerability, and~     pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5~     mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a~     high-fat breakfast was to be be investigated~   "
61152|NCT02256774|"~     Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of~     Combivir® on BILR 355 BS pharmacokinetics.~   "
61153|NCT02256761|"~     The study comprised two parts. The objective of the first study period was to assess the~     safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without~     food in male healthy volunteers and to determine the relative bioavailability of the BIRT~     2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG~     400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of~     BIRT 2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12~     days, or 750 mg qd for 28 days) in healthy male subjects (part 2)~   "
61154|NCT02256748|"~     The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite~     BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated~     high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for~     CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose~     of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days~   "
61159|NCT02256683|"~     The primary objective of this study is to assess whether Dabigatran leads to a faster~     complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon. The~     secondary objectives of this trial are to assess the impact of Dabigatran versus~     Phenprocoumon on complete LAA thrombus resolution rate until week 6 and change in LAA~     thrombus volume under treatment as well as to assess and compare safety and tolerability of~     both drugs. A total of 110 patients with atrial fibrillation and LAA thrombus will be~     randomized to receive either Dabigatran (150 mg bid) or Phenprocoumon (INR 2-3) for a least~     three weeks. Thrombus resolution will be determined by transoesophageal echocardiography~     (TEE) 3 weeks after start of study treatment and subsequently at week 4 and 6 if necessary,~     i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the~     resolution of the LAA thrombus. For those patients whose thrombus still exists after 6 weeks~     treatment, the study is also terminated. Further treatments will be decided at the~     discretion of the treating physician.~   "
61160|NCT02256670|"~     Pilot study to assess feasibility and patient acceptance of a text message cell phone~     application for patients with stage I-III, hormone receptor positive breast cancer who start~     adjuvant endocrine therapy.~   "
61161|NCT02256657|"~     The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of~     using a quality improvement toolkit among hospitals in Kerala, India. The quality~     improvement toolkit includes standardized admission and discharge sets, clinical pathways~     and an audit and feedback program.~   "
61162|NCT02256644|"~     Posttraumatic Stress Disorder (PTSD), as a common and serious mental health condition,~     affects about 25% of all military personnel that have served in combat. People suffering~     from PTSD may experience traumatic flashbacks, trouble sleeping, and problems in their~     relationships. This study is intended to help identify genes that influence and increase the~     risk of PTSD, to improve ways of detecting and treating the condition in the future.~      Previous research has studied genes that increase the risk of PTSD, but none of these have~     included a Veteran-only population. The current study focuses on US Veterans, utilizing the~     VA Million Veteran Program (MVP) database of approximately 300,000 participants as of August~     2014. In this context, participants with PTSD are referred to as cases and Veterans~     without PTSD are referred to as controls.~      This project will be done in three stages. The first stage will look at MVP-obtained data~     and electronic health record (EHR) data to implement methods for identifying combat-exposed~     case patients with PTSD and combat-exposed control patients without PTSD. The second stage~     will assemble and validate a study population of 20,000 participants including 10,000~     combat-exposed Veterans with PTSD as cases and 10,000 combat-exposed Veterans without PTSD~     as controls. The third stage will conduct genetic analyses (genotyping) comparing the~     cases to controls, to identify genes associated with increased risk of developing the~     condition.~   "
61163|NCT02256631|"~     VRC01 is an experimental monoclonal antibody, which is a substance that may have the~     potential to prevent mother-to-child transmission of HIV. The purpose of this study is to~     assess the safety and pharmacokinetics (PK) (which is how the body interacts with a drug) of~     VRC01 in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.~   "
61164|NCT02256618|"~     This is a pilot study to test feasibility and safety of intravenous infusion of autologous~     umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs~     of encephalopathy.~   "
61165|NCT02256605|"~     The purpose of this prospecitve randomized controlled trial is to compare effectiveness and~     patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with~     Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or~     deficient. The primary aim of this pilot study is to evaluate the effectiveness of once~     weekly verses daily D-3 dosing regimens based on the most current IBD supplementation~     guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is~     difference in adherence between dosing regimns.~   "
61166|NCT02256592|"~     Even in individuals treated for HIV, chronic immune activation persists and is associated~     with increased cardiovascular disease, liver disease, and mortality. HIV-infected~     individuals have imbalances in the community of intestinal microbes which is thought to~     contribute to increased and persistent inflammation. The purpose of this study is to examine~     the safety and durability of fecal microbiota transplant (FMT), the transfer of the~     bacterial community in stool from a healthy donor, in HIV+ individuals on anti-retroviral~     therapy. The study will also measure the effects of FMT on immune activation and~     inflammatory biomarkers in anti-retroviral treated HIV+ individuals.~   "
61167|NCT02256579|"~     This study is to investigate clinical utility of beta2 microglobulin as an early marker for~     renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.~   "
61168|NCT02256566|"~     The purpose of this study is to investigate the effects of a computerized cognitive training~     program (an attention and memory exercise performed on a computer) on thinking and memory in~     individuals with mood and anxiety disorders, and to begin to test whether this training~     affects symptoms of depression or anxiety.~   "
61169|NCT02256553|"~     The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed~     [Ambrosia artemisiifolia] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243~     (Timothy grass [Phleum pratense] extract, SCH 697243, GRASTEK®) sublingual tablets~     co-administered in participants 18 through 65 years of age with both ragweed- and grass~     polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma.~     The primary endpoint is the percentage of participants who experience at least one event of~     local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.~   "
61181|NCT02256397|"~     The purpose of this study is to assess whether comprehensive care enhanced with new~     technology to optimize asthma care in the home (using both a special sensor to track inhaler~     use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st~     second [FEV1]) is effective in reducing total days when medical treatment is given outside~     the home (in clinic, emergency department, or hospital) among children with severe asthma~     receiving comprehensive care.~   "
61182|NCT02256384|"~     The study will evaluate the performance of measuring respiration rate with the Respiratory~     Acoustic Monitoring (RAM).~   "
61183|NCT02256371|"~     A randomized double-blind controlled two centers study. The primary objective of this study~     will be to show a superiority of hypnosis over relaxation on pain intensity in patients with~     neuropathic pain.~   "
61170|NCT02256540|"~     This pilot study plans to learn more about the aging of blood vessels and arteries in women.~     As women age and go through menopause, their risk for cardiovascular disease increases. Also~     with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone~     replacement therapy to restore estradiol levels does not protect women from cardiovascular~     disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease~     risk. However, there are differences between men and women in their response to exercise. In~     older men, exercise improves the health of their arteries, but in postmenopausal women,~     exercise does not provide this benefit. The purpose of this pilot study is to determine~     whether low estradiol levels in postmenopausal women are responsible for the poor vascular~     response to exercise. In this study the investigators will also test whether treatment with~     resveratrol, a plant compound found in red wine, improves postmenopausal women's response to~     exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol~     will improve vascular responses to an acute bout of exercise.~   "
61171|NCT02256527|"~     Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital~     and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving~     Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in~     which patients received either the Taxus Liberte or XIENCE V drug eluting stent.~   "
61172|NCT02256514|"~     The purpose of this study is to evaluate daily dosing of oral immunotherapy~     hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical~     intervention or with recurrent tumor after surgery.~   "
61173|NCT02256501|"~     According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in~     pediatric, new modality of treatment is emerging. There are some case reports of~     administration of stem cell therapy. The investigators design the first randomized clinical~     trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16~     pts. in each group including cell therapy and control). The investigators assess the safety~     and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear~     cells in this patients compared to control group.~   "
61174|NCT02256488|"~     The purpose of this study is to evaluate the immunologic equivalence of three consecutive~     lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess~     immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit~     influenza vaccine (TIVf).~      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.~     Female subjects of childbearing potential were tested for pregnancy before the~     administration of the vaccine and included only if using and agreeing to continue to use~     contraception during the course of the study.~      The total study participation time per subject is about 3 weeks.~   "
61175|NCT02256475|"~     This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK),~     and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette~     syndrome (TS). The study will be conducted in approximately 18 male and female children (6~     to 11 years of age) and approximately 18 male and female adolescents (12 to 18 years of~     age). Both age groups will be divided equally into 3 dosing cohorts with 6 subjects each.~     Ascending doses will be evaluated as part of a staggered-cohort design. Study drug will be~     administered in each cohort for 14 consecutive days.~   "
61176|NCT02256462|"~     Objectives: To examine the effect of drug level-based personalized treatment of adalimumab~     in children with Crohn's disease. Design: A prospective, randomized, open label study.~     Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who~     are diagnosed with CD and are planned to receive adalimumab treatment. Main outcome~     measures: Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome~     measures: Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The~     effect of routine adalimumab drug monitoring-based treatment on trough levels and~     anti-adalimumab antibodies during therapy.~   "
61177|NCT02256449|"~     A multicentre, observational, prospective device registry, with no control group, designed~     to evaluate the efficacy and safety of the bioresorbable coronary device, used according to~     the indications of use, in daily clinical practice in a consecutive number of patients~     undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to~     be included in the registry.~   "
61178|NCT02256436|"~     Participants with metastatic or locally advanced/unresectable urothelial cancer that has~     recurred or progressed following platinum-based chemotherapy will be randomly assigned to~     receive pembrolizumab or Investigator's choice of paclitaxel, docetaxel, or vinflunine. The~     primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and~     Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.~      The study's interim analysis results demonstrated superior OS in the Pembrolizumab arm~     compared to the Active Comparator arm (investigator's choice: paclitaxel, docetaxel or~     vinflunine). Based on the positive outcome of the OS interim analysis, effective with~     Amendment 15, eligible participants who were allocated to the Active Comparator arm and~     experienced disease progression will be provided with the opportunity to crossover to~     receive pembrolizumab 200 mg one time every three weeks (Q3W) for up to two years of~     treatment in the Crossover Phase of the study.~   "
61179|NCT02256423|"~     This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to~     determine the comparative pharmacokinetic profile of the Test Investigational Medicinal~     Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the~     reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following~     single dose administration in healthy male and female subjects.~      The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3~     Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose).~     Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1)~     until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning~     of Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h~     post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified~     times throughout the study. There is at least 48 h between dose administrations.~   "
61180|NCT02256410|"~     Purpose of study is to test in a randomized controlled trial (RCT) the effects of the~     Nervomatrix device on various clinical outcomes of patients with low back pain, as well as~     its mechanisms of action.~   "
61185|NCT02256345|"~     This study will be performed to determine the safety, tolerability, and dose-response to~     inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:~        1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely~          given to subjects with HFpEF.~        2. Determine if there is a dose-response effect of nitrate supplementation on exercise~          capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations~          to exercise.~   "
61186|NCT02256332|"~     Effects of a plant based ingredient on blood glucose in Type II diabetes patients.~   "
61187|NCT02256319|"~     This clinical trial has been designed to study and compare changes in deep brain activity~     (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation~     with dexmedetomidine or propofol. The recording is made through a deep brain stimulation~     (DBS) electrode implanted for PD management.~      The investigators hypothesize that dexmedetomidine produces fewer changes as compared to~     propofol, and that those changes are consistent and recognizable when compared to activity~     in patients not exposed to any sedation. Typification of those changes would in the future~     allow for patients to undergo this surgery comfortably while not compromising the quality of~     the recording and of the final clinical outcome. The principal variable analyzed is the~     signal's power in each of the frequency bands, absolute and relative. The analysis will~     include usual clinical methods such as rapid Fourier transform (FFT) and window fast Fourier~     transform (WFFT), wavelet analysis, Gabor, and coherence.~   "
61188|NCT02256306|"~     The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered~     Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease~   "
61189|NCT02256293|"~     Individuals with diabetes often report that difficult thoughts and feelings about diabetes~     interfere with making healthy choices with regards to diabetes management. The purpose of~     this study is to evaluate a diabetes self-management group based on Acceptance and~     Commitment Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in~     treating psychological and behavioral difficulties. We are interested in whether individuals~     with diabetes will like an ACT-based diabetes management group and whether they find the~     group helpful.~   "
61190|NCT02256280|"~     At the end of anesthesia it's important to avoid residual neuromuscular block to ensure~     adequate respiratory function preventing postoperative pulmonary complications. This trial~     compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine)~     after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is~     faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic~     anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is~     to verify if there is a difference between sugammadex and neostigmine as regards adverse~     events after extubation and in the postoperative period (until the 30th day after surgery).~      Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value~     during an accelerometric train-of-four stimulation.~   "
61191|NCT02256267|"~     The aim of this two-period study is to compare how much of the study drug gets into the~     blood stream when it is given as a single oral dose and when it is given as a single oral~     dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic~     that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and~     other infections). Each participant will complete both study periods.~      The study will last about 34 days. Screening is required within 28 days before study drug is~     given.~   "
61192|NCT02256254|"~     The purpose of the study is to investigate if use of simvastatin is associated with the~     level of oxidative stress in humans. The association is examined by comparing changes in~     oxidative stress in a group treated with simvastatin with the change in a placebo group. The~     study is a randomized-based, double-blinded placebo-controlled study. Each treatment group~     consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The~     induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine,~     isolated from urine. A t-test will be performed to compare drug treatment with placebo. The~     results will be published.~   "
61193|NCT02256241|"~     Stage 1:~      Bone marrow will be collected from otherwise healthy patients undergoing orthopedic surgery~     - arthroplasty for the treatment of degenerative joint disease or traumatised patients. The~     bone marrow will be collected from disposable tissue that is removed during the normal~     sequence of the surgery. These cells will be used for:~      Establishment of the role of RING ubiquitin ligases in osteogenic progenitors proliferation~     and differentiation in culture.~      I. To determine the levels of RING ubiquitin ligases mRNA and protein in differentiating~     human mesenchymal precursor cells: To test the correlation between levels of RING ubiquitin~     ligases and degree of osteogenic differentiation, we will extract mesenchymal precursor~     cells from the collected tissue and test the mRNA protein level of RING ubiquitin ligases~     upon induction of differentiation. Specifically, we will compare the levels of RING~     ubiquitin ligases before and after the initiation of differentiational stimulus in time~     dependent manner by western blot and real time PCR analysis.~      II. To test the impact of specific RING ubiquitin ligases on differentiation of human~     mesenchymal precursor cells: to test the impact of RING ubiquitin ligases on the~     differentiation of mesenchymal precursor cell from the collected tissue by testing the~     expression of classical differentiational bone markers by flow cytometry (fibronectin,~     CD105) and by Alkaline phosphatase (ALP) activity assay. For this aim we developed both a~     constitutive and Dox-regulated conditional overexpression and shRNA lenti-viral systems that~     enables efficient modulation of these RING ubiquitin ligases level.~      III. Determine the role of RING ubiquitin ligases in proliferation and survival of human~     mesenchymal precursor cells: Via inhibition or overexpression of ligases in mesenchymal~     progenitor cells we will test the role of these ligases in proliferation and survival of~     mesenchymal precursors by using MTT assay, Propidion-Iodid (PI) and tunnel assays in flow~     cytometry analysis.~      Stage 2:~      Collection of connective tissue from patients with malignancies of musculoskeletal origin.~     The tissue that will be used is part of the resected tumor specimens. The tissue will be~     used for:~      The establishment of the role/s of RING ligases in musculoskeletal cancers using cell~     culture and in vivo activation. Test if the expression of selected positive candidates from~     stage 1 correlates with cancer development and progression in human-derived samples~     Independently of our mechanistic experiment we aim to determine the relevance of these~     ligases to human musculoskeletal cancers. As the first step we will screen primary tumor~     biopsies at the protein level correlates with cancer grade and prognosis. Toward this aim we~     recently generated a highly specific several anti-monoclonal antibodies in our laboratory as~     well use comercial available antibodies .~   "
61194|NCT02256228|"~     Can perioperative administration of intra-peritoneal local anaesthetics further reduce~     postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery~     (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.~   "
61245|NCT02255552|"~     The main objective of this study is to provide confirmatory evidence of efficacy of~     eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to~     skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the~     long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to~     exceed 48 weeks).~      Sites are currently being initiated into the study. Initiation of approximately 39 planned~     sites in the United States is expected to be completed by June 2016. The initiated sites can~     be found in the Contacts and Locations section of this posting in addition to a listing of~     the city and states of sites the investigators are working to initiate. This information~     will be updated on a rolling basis as additional sites are initiated.~   "
61195|NCT02256215|"~     Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially~     interfere with normal sleep, leading to significant impairment in patients' productivity and~     quality of life.~      The most common and potent of all treatment regimens are the dopaminergic agonist agents,~     which carry serious adverse events in their prolonged use despite their augmentation. A few~     basic studies have suggested a potential relationship between vitamin D and RLS. It has been~     implicated that dopaminergic system dysfunction plays a role in the development of RLS,~     while vitamin D has a protective effect on that system. This has been further substantiated~     by few clinical observations that showed prompt improvement of RLS patients upon receiving~     dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of~     vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement~     therapy, as has been demonstrated in a recent pilot study.~      This collectively points at vitamin D as a potential, more natural and safer treatment~     option for those suffering from RLS. However, the role of vitamin D in RLS has not been~     effectively investigated. The aim of this 12-week, triple-blinded, randomized,~     placebo-controlled trial is to confirm the relationship between vitamin D deficiency and RLS~     and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity~     of RLS, with predictions that the results will contribute to better understanding of the~     disease and its management.~      Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is~     take place over a duration of 2 years. It will be held in the city of Jeddah to assess a~     sample of Saudi residents of the Western region.~      It is comprised of a number of visits, with the first one consisting of a questionnaire that~     is to be answered regarding RLS, physical examination, electromyography, the objective~     multiple Suggested Immobilization test, and blood tests. The main purpose of the second~     visit is to establish a diagnosis of RLS.~      Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to~     determine the patient's adherence to trial procedures and pharmacological treatment.~      Then, patients are to visit the clinic every two weeks for the first two months, then at~     week 12. Patients will be assessed in regards to treatment response and adverse effects~     through history and physical examination along with further blood tests.~      Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate~     the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with~     predictions that the results will contribute to better understanding of the disease and its~     management.~   "
61196|NCT02256202|"~     There are actually no standardized quality assurance procedures included in pain treatment~     processes.~      In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested~     in pain therapy centres using the validated questionnaire Activity Index. The acceptance~     of electronic data capturing is tested in patients and therapy teams (doctors and nurses).~   "
61197|NCT02256189|"~     To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at~     moderate hypoglycemia in metformin-treated subjects with T2DM~   "
61198|NCT02256163|"~     The primary objectives of the study are~        -  to assess the contribution of alteration of each known gene on non-syndromic TAA.~        -  to map and identify unknown gene involved in the non-syndromic TAA.~   "
61199|NCT02256150|"~     To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that~     of standard therapy CTX through analyzing overall remission rate after treatment.~   "
61200|NCT02256137|"~     Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric~     malignancy. Unfortunately, treatment of childhood cancer continues to require agents~     designed to destroy malignant cell lines, and normal tissue is not always spared. While~     early treatment- related organ specific toxicities are not always apparent, many childhood~     cancer survivors report symptoms that interfere with daily life, including exercise induced~     shortness of breath, fatigue and reduced capacity to participate in physical activity. These~     symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most~     commonly described in older adults; it indicates persons who are highly vulnerable to~     adverse health outcomes. Frailty may help explain why nearly two thirds of childhood cancer~     survivors have at least one severe chronic health condition 30 years from diagnosis, why~     childhood cancer survivors are more likely than peers to be hospitalized for non-obstetrical~     reasons, and why they have mortality rates more than eight times higher than age-and-gender~     matched members of the general population.~      Frailty is a valuable construct because it can be distinguished from disability and~     co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability~     that identify individuals most at risk for adverse health outcomes. These investigators have~     recently presented data indicating that impaired fitness is present in survivors of~     childhood acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant~     because frailty, characterized by a cluster of five measurements of physical fitness, is~     predictive of chronic disease onset, frequent hospitalization, and eventually mortality in~     both the elderly and in persons with chronic conditions. Using a frailty phenotype as an~     early predictor of later chronic disease onset will allow identification of childhood and~     adolescent cancer survivors at greatest risk for adverse health. An early indicator of those~     at risk for adverse health will allow researchers to test, and clinicians to provide,~     specific interventions designed to remediate functional loss, and prevent or delay onset of~     chronic health conditions. The investigators goals include characterizing physical frailty~     over a five year time span in a population of young adult survivors of childhood cancer, as~     well as assessing the association between frailty and the increase in the number and~     severity of chronic health conditions.~   "
61201|NCT02256124|"~     The purpose of this study is to determine whether lamotrigine can improve cognitive and~     neurophysiological deficits in adolescents with Neurofibromatosis type 1.~   "
61202|NCT02256111|"~     This study will examine the effect of supervised exercise training on cardiopulmonary~     function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation~     therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to~     date has examined the efficacy, tolerability, and safety of exercise training to prevent~     and/or mitigate common adverse toxicities in men receiving combination androgen suppression~     therapy for hormone-naïve prostate cancer.~   "
61203|NCT02256098|"~     The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent~     clinical track record, good survival rates (98% 10 years survival in patients aged < 55~     years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at~     two years follow-up)(von et al., 2009).~      The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is~     designed to provide better range of motion and address the unstable feeling some patients~     experience during everyday activities, such as stair descent and bending. To date (March~     2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and~     positive feedback was received regarding patient recovery, stability and motion.~      The objective of this study is to accurately assess and compare migration, clinical and~     radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented~     ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed~     Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The~     primary objective of this study is to compare the magnitude and pattern of migration of the~     prostheses (Femoral and Tibial component). The secondary objective of this study is to~     compare clinical and radiological outcome of the prostheses and PROMS. The tertiary~     objective of this study is to compare clinical and radiological outcome and PROMS of the~     prostheses with migration data.~      This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System~     and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC~     Sigma Knee System will be included in this study.~      The study population will consist of patients with symptomatic osteoarthritis of the knee~     scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The~     Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of~     which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other~     indications. We anticipate that inclusion can be accomplished within a 1 year period and~     that the total study duration is 3 years.~      Main study parameters/endpoints are:~        -  Migration of the prosthesis with respect to the host bone measured by means of roentgen~          stereophotogrammetric analysis (RSA).~        -  Patient Reported Outcome Measures by means of questionnaires.~   "
61204|NCT02256085|"~     This is a randomized controlled trial (RCT) on the efficacy of repetitive Transcranial~     Magnetic Stimulation (rTMS) in the treatment of Depersonalization Disorder (DPD). TMS~     applies a magnetic field to the brain for a brief period of time. TMS is a procedure that~     involves 30 minute-long daily sessions every weekday for a series of weeks. The~     investigators are testing whether TMS can treat Depersonalization Disorder (DPD).~   "
63715|NCT02223299|"~     The purpose of this study is to determine if adding over the counter nutritional supplements~     will have a benefit to participants currently taking prescribed antidepressants who have not~     experienced complete remission of their depression symptoms.~   "
61205|NCT02256072|"~     The goal of this study is to develop and test an advance planning tool to help seniors~     understand projected health needs and plan ways to remain in their own homes when these~     crises occur. In this phase of the study through partnerships with seniors, senior community~     groups, area agencies on aging, and home care agencies the investigators are conducting a~     two-armed (attention control and intervention) randomized controlled trial.~      Individuals will be randomly assigned to one of two interventions: attention control or the~     advance planning tool. The investigators attention control group will control for the~     possibility that regular contact with the study team may improve outcomes in participants~     randomized to the intervention website. Participants in the attention control arm will~     navigate an electronic educational session via a National Institute on Aging at NIH Web site~     about physical activity and exercise as it is a topic of interest to seniors. A minimum of~     15 minutes and a maximum of 45 minutes will be allotted for navigating the Web site. The Web~     site is interactive and comparable to the intervention tool:~     http://go4life.nia.nih.gov/get-started).~      If randomized to intervention, subjects will be introduced to the advance planning tool, the~     Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is a~     Web-based planning tool that provides information for seniors related to advanced health~     planning for home services in specific content areas of: hospitalizations, falls,~     Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan website~     is also interactive in that it allows participants to enter their information and share it~     with others to facilitate conversations and decision-making. Participants will navigate and~     complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes~     and a maximum of 45 minutes to navigate the tool as part of the study.~      All participants will be administered a pre- and post-test before and after viewing the~     website they were randomized to. All participants will be followed up at one and three~     months post via a brief phone call where follow-up questions will be asked of all~     participants.~   "
61206|NCT02256059|"~     Treatment of lateral fractures of the clavicle is challenging and has been controversially~     discussed for a long time due to high non-union rates in non-operative treatment and high~     complication rates in surgical treatment. A recently developed implant was proven to ensure~     a biomechanically sufficient fixation of fractures leading to bony union and promising~     functional outcome in a small collective of patients.~   "
61207|NCT02256046|"~     Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic~     management of esophageal varices.~      This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta~     University, in at least six months in the period from august 2014 to march 2015 or until the~     target number of patients reached whichever is longer.~   "
61208|NCT02256033|"~     The purpose of this study is to test whether mild liver impairment affects blood levels of~     istradefylline in humans. Decreased liver function could possibly increase istradefylline~     levels.~   "
61209|NCT02256020|"~     Investigators anticipate to develop a customized WC-MAE for the improvement of insomnia and~     depression in wheel-chair dependent elders, and to identify related mechanisms as biomarkers~     for prediction and prevention of insomnia and depression in elders with physical disability~     in long term care facilities.~   "
61210|NCT02256007|"~     This study designs and develops an evidence-based game approach that will enhance the~     investigators understanding and usability of electronic tools to measure cognitive and~     sensorimotor abilities in an inpatient rehabilitation stroke population.~   "
61211|NCT02255994|"~     The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse~     recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE~     I.~   "
61212|NCT02255981|"~     The purpose is to assess the efficacy of acupuncture (Traditional Chinese Medicine) for~     chronic macular diseases, and help to solve a problem for cases that have no treatment, no~     response to the conventional treatment, or have no access to medical treatment.~   "
61213|NCT02255968|"~     The primary objective of the study is to determine the safety and tolerability of multiple~     doses of orally administered EDP-788. Secondary objectives of the study are to describe the~     pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally~     administered drug.~   "
61214|NCT02255955|"~     Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on~     postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a~     lumbar disk surgery.~   "
61215|NCT02255942|"~     Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric~     Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves~     as a Reference.~   "
61216|NCT02255929|"~     The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery~     for essential tremor. The gamma knife places a small lesion in the brain to suppress~     tremors.~   "
61217|NCT02255916|"~     The purpose of this study is to determine the effects of live sound-bed music on~     physiological and psychological parameters in staff of a hospital oncology ward.~   "
61218|NCT02255903|"~     The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios~     and amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated~     postdate pregnancy~   "
61219|NCT02255890|"~     The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as~     well as the change in functional outcomes (e.g. incontinence or erectile function) from~     baseline. Secondary objectives are to establish which indications lead to treatment with IRE~     Nanoknife® setting and safety assessment measured by number of complications and adverse~     events.~   "
61220|NCT02255877|"~     Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel~     staple placement when utilized for surgical wound closure after bi lateral unicompartmental~     or bi later total knee replacement.~   "
61221|NCT02255864|"~     The purpose of this study is to evaluate the safety and performance of a new coronary artery~     stent for treating blockages in the arteries supplying blood to the heart muscle. The~     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the~     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away~     over time, leaving no permanent implant after the blood vessel has healed.~   "
61222|NCT02255851|"~     The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the~     CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve~     stenosis indicated for TAVR.~      Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic~     information and detailed procedural data will be captured and documented in a registry case~     report form.~      All Sentinel filters will be sent for histopathology at an independent core-lab.~   "
61246|NCT02255526|"~     This project will compare BodyGuardian (BG) device measurements of breathing and activity~     levels to the gold standard measurement techniques of gas exchange using a mouthpiece~     connected to flow and gas analyzers measures for breathing and metabolic rate (indirect~     calorimetry) for activity, We are hopeful these comparisons will help us improve upon the~     measurements being made in the current version of the BG device.~   "
61223|NCT02255838|"~     Flexible bronchoscopes are typically reusable and therefore need high level disinfection to~     prevent inadvertent spread of microbial pathogens from patient to patient. The process of~     disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may~     not be readily available for another patient. One solution to this problem was to use a~     single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of~     the bronchoscope.(Colt, Beamis, Harrell, & Mathur, 2000). Another way to eliminate potential~     hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a~     disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been~     used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen~     & Fredensborg, 2013; Pujol, López, & Valero, 2010; Tvede, Kristensen, & Nyhus-Andreasen,~     2012). Further advancement in the imaging and handling of this disposable flexible~     bronchoscope now allows for the purpose of bronchoscopy and broncho-alveolar lavage in~     critically ill patients with pulmonary compromise. (FDA approval: 05-11-2013 date)~      The aim of the study is to compare image clarity, suction capacity, and handling performance~     of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition,~     the investigators intend to perform a cost analysis.~   "
61224|NCT02255825|"~     To gain knowledge about how patients undergoing prenatal diagnosis for a fetal abnormality~     understand and react to Whole Genome Sequencing (WGS) testing, so that the investigators can~     develop more ethical and responsible approach to patient education, counseling, and return~     of results for patients.~   "
61225|NCT02255812|"~     Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami~     and bitter. The receptors found on the tongue are also found in the entire gut. The~     correlation of stimulation of these gut receptors and brain activity has not yet been~     examined. The objectives are to investigate the effect of different taste substances on i)~     regional brain activity and ii) satiation peptide release.~   "
61226|NCT02255799|"~     This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week~     trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the~     subacute or chronic recovery period. The study will recruit 160 persons with TBI and~     functionally important memory problems during a four-year period of open recruitment.~      The study aims are:~        1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the~          Hopkins Verbal Learning Test-Revised Total Trial 1-3;~        2. To evaluate the effects of treatment with donepezil on memory-related activities as~          measured by the Everyday Memory Questionnaire;~        3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric~          symptoms, community participation, quality of life, and caregiver experiences.~   "
61227|NCT02255786|"~     The investigators will develop and pilot test an intervention called ACT for Parents which~     aims to decrease stress and improve quality of life in parents of children < 15 years who~     have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be~     conducted to gather initial data on the treatment feasibility and acceptability, detect~     treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine~     the treatment design for a future clinical trial.~   "
61228|NCT02255773|"~     The goal of this research study is to learn more about fatigue and how it affects your~     behavior as well as your willingness to learn new behaviors.~   "
61229|NCT02255760|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study~     evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy~     adult subjects 18 to 60 years of age.~   "
61230|NCT02255747|"~     This study is to evaluate the effect of anal dilation in infants and children with~     constipation.~   "
61231|NCT02255734|"~     Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)~     after Intravenous Infusion in Healthy Volunteers.~   "
61232|NCT02255721|"~     The SHIP study is a randomized controlled trial of an intervention for preschool children~     with sleep problems, in which we aim to give parents the knowledge, motivation, and skills~     necessary to set goals, problem-solve, and improve their child's sleep. In collecting three~     years of follow-up data, we will be able to determine the impact of the SHIP intervention on~     childhood sleep problems, obesity, academic achievement, and emotional and behavioral~     problems, as well as parental stress and daytime tiredness. This study has the dual~     potential to expand treatment resources for young children with behavioral sleep problems~     and to increase our scientific understanding of the long-term consequences of early~     childhood sleep problems.~   "
61233|NCT02255708|"~     The present study aims to assess through surface electromyography, the effectiveness of~     proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing~     muscles of the scapula and the anterior tibial muscle.~   "
61234|NCT02255695|"~     The objective of this study was to evaluate the effects of a school-based exercise program~     on posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was~     a Randomized controlled trial. The hypothesis was that the exercise group would have the~     postural deviations corrected, would have the trunk range of motion increased and would have~     the prevalence of pain decreased, while the control group would have not. Three schools from~     Brazil participated. The students that have been included (n=300) were randomly allocated to~     experimental (EG) or control group (CG). The intervention for EG consisted in a program~     based on stretching and strengthening exercises, applied twice a week, for eight weeks, with~     group sessions of 50 minutes. CG did not perform any intervention. Qualitative and~     quantitative postural evaluation (PAS/SAPO), musculoskeletal pain (self-report) and trunk~     mobility were collected.~   "
61247|NCT02255513|"~     This study will examine the efficacy and safety of HLD200 (methylphenidate) in patients age~     6-12 years with ADHD. This study has a 6-week dose optimization period followed by a one~     week double blind randomization assessment.~   "
61248|NCT02255500|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in~     subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee~     arthroplasty (TKA).~   "
61249|NCT02255487|"~     This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when~     the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute~     surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept~     device and half of the subjects will receive the respective institution's Standard of Care~     (SoC).~   "
61235|NCT02255682|"~     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the~     most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily~     basis, 40 % of these are taking the medication without having any other risk factors for~     cardio-vascular diseases than elevated blood-cholesterol i.e. they are in primary~     prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk~     of developing diabetes when taking statins. This has led to an increased debate about the~     use of statins in primary prevention. Furthermore a large meta-analysis has shown that to~     prevent one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5~     years. These data suggest that more conservative use of statins to prevent CVD in otherwise~     healthy individuals at low risk for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which~     potentially can prevent a physically active lifestyle. The biomedical background of these~     side effects is not fully elucidated but it has been shown that there is a link to~     decreasing levels of an important enzyme, Q10, which plays a role in muscle energy~     metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prevent) physical exercise training? Furthermore we would~     like to answer the following questions:~        1. Does statin treatment impair (or even prohibit) physical exercise training?~        2. Does statin treatment cause:~             -  Decreased muscle strength?~             -  Skeletal muscle inflammation?~             -  Decreased mitochondrial respiratory function?~        3. Abnormal glucose homeostasis?~   "
61236|NCT02255669|"~     The purpose of this study is to compare the duration of stent patency between partially~     covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.~   "
61237|NCT02255656|"~     Primary Objective:~      To evaluate long-term safety of alemtuzumab.~      Secondary Objectives:~      To evaluate long term efficacy of alemtuzumab. To evaluate the safety profile of patients~     who received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment.~      To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization~     of patients who received alemtuzumab.~      To evaluate as needed re-treatment with alemtuzumab and other DMTs.~   "
61238|NCT02255643|"~     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic~     pain not responsive to medication. An electrode is placed on the surface of the brain and~     connected to a programmable battery in the chest.~      The strength of stimulation can be individually adjusted by changing the voltage of~     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low~     voltage will not provide pain control. The aim of this study is to analyze the optimal~     stimulation parameters in patients already implanted with a motor cortex stimulation who~     have received good pain relief. The actual voltage may vary widely between patients but the~     investigators feel that there may be an ideal voltage if it is measured as a percentage of~     motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle~     contraction then a PMT = 80% would be a voltage that was eighty percent of that value.~     Although the actual voltage may be widely different between patients, the percentage needed~     may be very similar. The investigators therefore plan to measure the effect of different~     percentages of PMT in patients already being treated with motor cortex stimulation.~      Systematic analysis of the findings of this study might help the individual participant and~     future patients to better programming and less side effects.~   "
61239|NCT02255630|"~     Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of~     medals. However, most previous research has shown that β2 agonists do not improve exercise~     performance in either asthmatic or non-asthmatic athletes. Although the majority of these~     studies do not show an ergogenic effect, the small number of studies with extended exercise~     bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet~     sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have~     different effects on these two groups of athletes, the investigators will measure exercise~     performance in both female and male elite cyclists. The investigators hypothesize that~     athletes will perform better during a combination steady-state/sprint exercise task~     following salbutamol administration.~   "
61240|NCT02255617|"~     The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in~     cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance~     therapy with lactulose and/or rifaximin or metronidazole.~   "
61241|NCT02255604|"~     The investigators want to investigate whether specific immunotherapy can be delivered~     directly into a lymph node. The investigators think that a direct introduction of allergen~     to the antigen presenting cells in the lymph node a give a strong immune response and that~     this can change the number of injections needed in allergen immunotherapy. The investigators~     do measurements of clinical effect and a variety of paraclinical test to see if the~     investigators can find af biomarker of successful specific immune therapy of grass allergy.~   "
61242|NCT02255591|"~     The main objective of the trial is to complete a double-blinded randomized controlled trial~     of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident~     technique by estimating the time of performance of lumbar plexus blocks in healthy~     volunteers.~      Secondary objectives include a) estimates of number and depth of needle injections, distance~     of injection site from the midline, minimal electric nerve stimulation to trigger muscular~     response and the type of response, and volunteer discomfort during block injection, b)~     measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of~     sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator~     nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus~     block, e) perineural and epidural distribution of local anesthetics added contrast~     visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the~     Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in~     healthy volunteers.~      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar~     Ultrasound technique, and that the success rate of the Shamrock technique is equal to or~     higher than the Lumbar Ultrasound Trident technique.~   "
61243|NCT02255578|"~     Women with Polycystic ovary syndrome (PCOS) experience multiple fertility treatments, a long~     treatment duration and a low pregnancy prevalence. This syndrome is frequently accompanied~     by overweight and insulin resistance which can mediate the limited response to fertility~     treatment. The Endobarrier device was shown to be efficient in weight and glucose lowering.~     The aim of this study is to investigate the ability of the Endobarrier device to improve the~     outcome of fertility treatments in women with PCOS.~   "
61244|NCT02255565|"~     The purpose of this study is to determine whether Quillivant XR is effective in the~     treatment of ADHD in children with Autism Spectrum Disorder (ASD).~   "
69150|NCT02152228|"~     This is an observational, international, open label, pilot study to evaluate the safety,~     tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult~     hypoparathyroid volunteers.~   "
61252|NCT02255448|"~     Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke~     volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula~     CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Cardiac output~     monitoring is well established and validated for guiding fluid administration and~     resuscitation in intensive care and perioperatively in the non-pregnant population.~     Available CO monitoring methods may risk maternal health or fetal wellbeing or are~     unvalidated in the pregnant population. Invasive and semi-invasive methods of measuring CO~     such as the pulmonary artery catheter, the 'gold standard' require invasive arterial or~     central access negating their use in all but a select group of labouring women and have~     potentially serious risks attached to their usage. Echocardiography is a well-established~     and validated technique requiring no invasive access but the requirement for an experienced~     operator limits routine usage. It uses an external ultrasound probe to scan the heart.~      Several novel non-invasive cardiac output monitors have recently come to the market~     including the estimated cardiac output esCCO monitor (Nihon Kohden) which uses Pulse Wave~     Transit Time (PWTT) to estimate cardiac output. It requires 3-lead Electrocardiography and~     pulse oximetry alone which is part of the routine monitoring for high risk patients on the~     labour ward.~      The investigators research aims to evaluate the accuracy and precision of the esCCO in~     pregnant women and subsequently assess its utility during medical interventions such as~     epidural analgesia or caesarean section. The initial validation will take place in an~     antenatal clinic where women are assessed using Doppler echocardiography. The investigators~     will then compare the echocardiography results vs the esCCO results.~   "
61253|NCT02255435|"~     Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat~     expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first~     intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological~     consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster~     biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an~     increased sensitivity to oxidative stress.~      A hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which~     play a major role in disease progression. Studies have demonstrated that nuclear factor~     erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in patients with~     Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and~     induce antioxidant target genes is hypothesized to be therapeutic in patients with~     Friedreich's ataxia.~      This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone~     (RTA 408) in the treatment of patients with Friedreich's ataxia.~      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,~     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in~     patients with Friedreich's ataxia.~      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,~     parallel study to evaluate the safety, efficacy, and pharmacodynamics of up to 2 dose levels~     of omaveloxolone (RTA 408) in patients with Friedreich's ataxia. Eligible patients in Part 2~     will be randomized 1:1:1 to receive omaveloxolone (RTA 408) (at one of 2 doses chosen from~     Part 1), or placebo.~   "
61254|NCT02255422|"~     Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a~     wide range of biochemical and genetic mitochondrial defects and variable modes of~     inheritance. Currently there are no effective treatments for this disease. Despite the~     heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that~     the pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain~     invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial~     respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP),~     often resulting in muscle weakness, exercise intolerance, and fatigue in patients with~     mitochondrial myopathies.~      RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor~     kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and~     anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can~     increase mitochondrial respiration and biogenesis. Collectively, available data suggest that~     the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially~     improve muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial~     biogenesis in patients with mitochondrial myopathies.~      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,~     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in~     patients with mitochondrial myopathies.~      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,~     parallel study to evaluate the safety, efficacy, and pharmacodynamics of up to 2 dose levels~     of omaveloxolone (RTA 408) in patients with mitochondrial myopathies. Eligible patients in~     Part 2 will be randomized 1:1:1 to receive omaveloxolone (RTA 408) (at one of 2 doses chosen~     from Part 1), or placebo.~   "
61255|NCT02255409|"~     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine~     Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in~     Trial V118_05~   "
61256|NCT02255396|"~     Estradiol and Testosterone are two important hormones for the regulation of an effective~     spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in~     seminal plasma of men with non-obstructive azoospermia may be a predictive test before~     surgical testicular biopsy to determine the chance of a positive sperm extraction to use for~     ICSI.~   "
61257|NCT02255383|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona fixed bearing knee implants used in total knee~     arthroplasty. The assessment will include implant survivorship and clinical performance.~   "
61258|NCT02255370|"~     Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of~     inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible~     for the anti-inflammatory effect of curcumin~      Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with~     thiopurines in the prevention of Crohn's disease post-operative recurrence.~   "
61259|NCT02255357|"~     This proposal describes a combined laboratory and clinical trial preliminary investigation~     to advance medication development for cocaine dependence. The main objective is to test~     whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To~     measure the stress sensitivity, this study will evaluate a new stress challenge: a)~     Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its~     effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone~     (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and~     subjective response to intranasal desmopressin. These measures will be tested during a 7-day~     inpatient abstinence induction hospitalization. For those patients with family and work~     obligations, an outpatient abstinence induction procedure is available. The response to the~     desmopressin challenge will be compared to a cohort of matched control subjects. After~     abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized,~     placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this~     reduces the relapse risk.~   "
61260|NCT02255344|"~     Through the National Registry of patients with ACS in the IMSS (RENASCA IMSS) the~     investigators will know the real world in terms of risk factors frequency, clinical~     presentation and its complications, and in the end they can build a risk model for early~     Major Cardiovascular Events (MACE).~   "
61261|NCT02255331|"~     Patients with a total hip replacement may require early revision surgery due to an adverse~     local tissue reaction or bone resorption that occurs due to wear debris released from the~     implant. A non-invasive imaging biomarker does not exist to identify or to follow total hip~     replacement patients who are most at risk for suffering this type of premature implant~     failure. This study will evaluate magnetic resonance imaging (MRI) as a biomarker to predict~     a failing hip replacement.~   "
61262|NCT02255318|"~     The therapeutic management of patients with cancer often requires the establishment of a~     chamber implantable catheter. Infections are the main complication of these catheters. These~     infections may be responsible for a significant impairment of quality of life for patients,~     and may increase the frequency and duration of hospitalizations. The rate of mortality from~     these infections is about 17%. The objective of this study is to evaluate the efficacy of a~     1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections~     related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral~     nutrition.~      This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in~     patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline~     (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive~     pressure). The lock will be instilled after the end of the session IV treatment~     (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary~     endpoint will be the rate IRCIC in both groups.~   "
61263|NCT02255305|"~     The purpose of the study is to determine the safety and efficacy of Fecal Microbiota~     Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection~     (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI~     within 90 days of an admission for relapse of CDI will be approached to participate in this~     open-label, randomized controlled trial. Patients will either be randomized to the~     intervention group (receive FMT via retention enema) or the control group (receive~     antimicrobials targeting CDI).~   "
61264|NCT02255292|"~     Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including~     the cannabidiol (CBD) which does not posses the psychotropic effects of~     D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects~     and they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence~     from clinical trials among cancer patients is needed. The aim of the current study is to~     evaluate the impact of CBD as single treatment among cancer patients.~   "
61265|NCT02255279|"~     The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a~     more immunogenic and effective response compared with conventional influenza vaccines in~     elderly and adults.~      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children~     6 to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted~     trivalent influenza vaccine (TIV).~   "
61266|NCT02255266|"~     This study is conducted in Europe. The aim of this study is to investigate Long-Term~     Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.~   "
61267|NCT02255253|"~     In this research, the investigators aim to compare the antihypertensive efficacy and safety~     of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and~     diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate~     hypertension. The research will be conducted in the rural area in Hebei province, where~     people have a high sodium diet in their daily life. The 1200 eligible subjects will be drawn~     from 12 local county-level hospitals. Subjects will be randomly allocated in double-blind~     manner into ARB or HCTZ group to be administered telmisartan 40mg per day or~     hydrochlorothiazide 25mg per day respectively. After two-month treatment, the investigators~     will evaluate and compare the antihypertensive efficacy and safety between the two~     therapies.~      The first objective of the research is to compare the antihypertensive efficacy of~     monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and~     diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate~     hypertension.The second objective is to compare the safety between the two therapies~     applied.~      Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure~     between treating high sodium intake patients with mild to moderate hypertension with~     telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy~     differences of lowering the systolic pressure between treating high sodium intake patients~     with mild to moderate hypertension with telmisartan and hydrochlorothiazide.~      This research is a multicenter randomized double-blinded parallel controlled trial targeting~     on high sodium intake patients with mild to moderate hypertension in China. The eligible~     1200 subjects will be randomly divided into ARB and HCTZ two groups, treated with~     monotherapy of telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively.~     Then, the compliance of the patients will be followed after a week. The investigators will~     evaluate the efficacy of blood pressure control and the safety of the medicines after one~     month and two months of the beginning of therapies. Figure 1 shows the research process.~   "
61268|NCT02255240|"~     The purpose of this study is to test an intervention that uses home console video games to~     encourage increased physical activity among postmenopausal breast cancer survivors.~   "
61269|NCT02255227|"~     This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal~     vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by~     immunosuppressants and/or biotherapies. At present such patients are poorly protected by~     anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is~     much weaker than in the general population. There are two types of anti-pneumococcal~     vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate,~     Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising~     immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13®~     followed by one dose of PSV-23® after an interval of two months. In the case of young~     children infected with HIV, the recommendation is to multiply doses of Prevenar13® before~     the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.~      Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD~     patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine,~     PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined~     with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer~     against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We~     also want to evaluate the immunological impact of these different strategies in their~     capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim,~     we are studying all immunological functional aspects of the antibodies and B lymphocytes~     induced by the two vaccine strategies.~   "
61445|NCT02252913|"~     The purpose of this study is to evaluate the safety and tolerability of volitinib in~     combination with docetaxel in patients with locally advanced or metastatic gastric cancer~     and to determine the Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of~     volitinib in combination with docetaxel.~   "
61270|NCT02255214|"~     Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages~     over a general anaesthetic however contraindications include coagulopathy. Guidelines~     suggest a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5~     or greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of~     its effects is required.~      The Hemochron Signature Elite is a portable micro coagulation system that can be used as a~     point of care (POC) anticoagulation monitoring device. Marketing is focussed on its~     accuracy, convenience and efficiency in delivering a coagulation result.~      This study will assess the accuracy of this device in calculating the International~     Normalised Ratio (INR) result. This will be compared to another INR result obtained on the~     same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh~     (RIE) laboratories.~      The study will include patients presenting for surgery who have had their warfarin therapy~     stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are~     currently identified in preoperative assessment clinics, on average 12 weeks prior to their~     date of surgery.~      Anecdotally there appears to be a difference between the 'expected' and actual INR when a~     POC device is used. Concern exists that patients may be inappropriately denied the potential~     benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or~     conversely the investigators may be proceeding with CNB in patients with an unacceptably~     high INR if POC provides a falsely low result. There is also the possibility of improving~     hospital efficiency using this device as it provides a result much faster than the~     laboratory.~   "
61271|NCT02255201|"~     The purpose of this study is to determine the effects of four different pre-workout~     beverages as compared to placebo on muscular strength and endurance, perceived energy and~     cognitive performance in healthy adult males.~   "
61272|NCT02255188|"~     The purpose of this study is to determine whether the Vascular prosthesis manufactured by~     Electrospinning is safe with respect to the development of thrombosis.~   "
61273|NCT02255175|"~     Using neuroimaging, the investigator will study the effects of estrogen on mood and brain~     function in perimenopausal women either with or without depression.~   "
61274|NCT02255162|"~     This research study is evaluating the safety and tolerability of the drug lenalidomide in~     combination with and following mismatched related donor microtransplantation in high risk~     AML patients in first remission. This study also aims to define the maximum tolerated dose~     (MTD) of lenalidomide given in this setting.~      Microtransplantation seeks to give the participant donor cells in hopes that those cells can~     attack the underlying cancer. However, since the donor cells do not replace all of the host~     cells, it can hopefully avoid many of the serious risks involved with standard transplant,~     including graft-vs.-host disease (GVHD) - a complication where the donor cells attack the~     participant's normal body. Recent studies have suggested that lenalidomide can help aid~     donor cells to attack cancer when given after a stem cell transplant. This trial is trying~     to see if lenalidomide can help encourage the attack of leukemia cells by donor cells given~     as part of microtransplantation.~      The FDA (the U.S. Food and Drug Administration) has approved lenalidomide but it has been~     approved for other uses such as in the treatment of other cancers including multiple myeloma~     and non-Hodgkin lymphoma. Although lenalidomide has been studied in patients with AML, it~     has not been approved by the FDA for standard use in AML. Lenalidomide is a compound made by~     the Celgene Corporation. It has properties which could demonstrate antitumor effects. The~     exact antitumor mechanism of action of lenalidomide is unknown.~   "
61275|NCT02255149|"~     This study will involve placing donor bone into the back of lower jaw then covering with a~     newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it~     will be removed. Implants will be placed in the newly formed bone.~      The goal of this study is to test how well using a newly designed titanium mesh and bone~     particles can grow bone in the back of the lower jaw. The investigators are also checking if~     the newly formed bone will stay around implants that will have been in use for 12 months.~   "
61276|NCT02255136|"~     The purpose of this study is to test whether individualized homeopathic medicines can~     produce any significant effect beyond placebo in treatment of allergic rhinitis and/or~     induced bronchial asthma~   "
61277|NCT02255123|"~     This study is a multicenter, non-randomized, retrospective study to collect long term (4~     years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05~     study (NCT00466804) to evaluate participant and graft survival.~   "
61278|NCT02255110|"~     This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety,~     tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with~     locally advanced unresectable or metastatic soft tissue sarcoma (STS).~   "
61279|NCT02255097|"~     This is a study of single-agent pembrolizumab (MK-3475) in participants with recurrent~     and/or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on~     platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab~     will provide a clinically meaningful objective response rate (ORR).~   "
61280|NCT02255084|"~     Despite the existence of an effective screening test (pap smear), cervical cancer is, every~     year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4~     in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore~     necessary to develop new strategies to reach these women. The etiological factor of this~     cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).~     Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with~     HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal~     self-sampling with HPV test is a powerful means to increase the participation rate in~     cervical cancer screening.~   "
61281|NCT02255071|"~     In recent years, there is an increasing trend in the number of patients with~     Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in~     patients with non-erosive reflux disease. According to the theory of traditional Chinese~     medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the~     chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical~     efficacy of Neiguan (P6 point) acupressure in patients with GERD.~   "
61446|NCT02252900|"~     Primary objective: To describe the evolution of cerebral lesions in IE patients (number of~     patients with abnormal cerebral MRI in acute phase of IE and during follow-up).~   "
61282|NCT02255058|"~     It was decided to develop a comprehensive disability score specifically designed for~     patients receiving prolonged mechanical ventilation (PMV); the collection of information~     included in the score should not impose any further intervention beyond what is routinely~     performed. So a new questionnaire was created (called the Multi-INdependency Dimensions~     (MIND) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories~     and 18 items. Each question was adapted to have a 5 item Likert scale.~      The primary objective of the study will be to evaluate the psychometric performance of the~     MIND score in terms of validity, reliability and sensitivity to change over time. The~     secondary objective will be to assess the inclusion of biological markers on the overall~     performance of the MIND score~   "
61283|NCT02255045|"~     The investigators propose that the sustained vaginal administration would have a better~     response with respect to pain, and a better safety profile than the oral administration of a~     non-steroidal anti-inflammatory drug.~      Assess the relief of the symptoms associated to dysmenorrhea a specific survey was~     elaborated that also included a Visual Analog Scale (VAS) to make objective and measure~     dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).~   "
61284|NCT02255032|"~     The study is designed to evaluate the safety and efficacy of triamcinolone acetonide,~     CLS-TA, in subjects with macular edema following non-infectious uveitis. A single~     suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects~     with macular edema following non-infectious uveitis.~   "
61285|NCT02255019|"~     The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to~     examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid~     being exposed to unnecessary X-rays and invasive examination.~      It is the investigators expectation that this study will benefit to future patients, as they~     will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort~     associated with x-ray examinations. The aim is that patients with IBD achieve better and~     earlier treatment and if this is achieved it both benefits patient and public health. An~     earlier treatment leads to fewer hospitalizations and thereby saving the community money.~      The investigators hope is that the investigators study will show that MRI is one of the best~     tool to examine patients with IBD and that this in future leads MRI to be the first choice~     in contrary to all examinations with x-ray exposer, unless there is any contraindication to~     MRI.~   "
61286|NCT02255006|"~     Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents~     endothelial function, but no study has investigated whether acupuncture protects against~     ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.~      This is a prospective crossover study clinical trial. In the first crossover study, 20~     healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture~     or control. Endothelium-dependent, FMD of the brachial artery will be measured before and~     after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15~     minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till~     the end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers~     are administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2~     inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for~     acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR~     injury are same as above mentioned.~   "
61287|NCT02254993|"~     Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in~     healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for~     safety and microbiology parameters. A subset of subjects will be assessed for~     pharmacokinetic parameters. No longer enrolling study subjects in Part A.~      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and~     female subjects 18-75 years of age. All subjects will be assessed for safety,~     pharmacokinetic, and microbiology parameters.~   "
61288|NCT02254980|"~     In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have~     superior wear resistance and improved mechanical properties as compared to that of standard~     highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE~     although several trials are ongoing. All of these trials use uncemented acetabular cups~     intended for biological fixation. In many countries the standard fixation method for the~     acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a~     lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation~     when used in acetabular components. The aim of the study is to compare migration, linear~     wear and clinical results between two types of cemented acetabular cups.~   "
61289|NCT02254967|"~     The main objective of the study is to evaluate whether the extended duration fidaxomicin~     therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at~     30 days after end of treatment (Day 40 or Day 55).~   "
61290|NCT02254954|"~     This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study.~     Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the~     standard of care treatment for GBM. The study consists of a screening period, a treatment~     period, and a 30-day safety follow up period. The treatment period includes 6 weeks of~     concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of~     maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has~     completed study treatment and the 30-day safety follow-up period.~      The planned duration of the study is approximately 34-38 months depending on the number of~     dose levels and cohorts of subjects enrolled. Subject participation in the study will be for~     approximately 16 months.~   "
61291|NCT02254941|"~     The purpose of this study is to evaluate, in terms of overall survival, the benefit of~     monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a~     deferred basis after progression to treatment with chemotherapy alone.~   "
61305|NCT02254759|"~     This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to~     investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe~     CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical~     activity and sedation to explore the pharmacodynamic interaction between the gama-amino~     butyric acid (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA~     positive allosteric modulator midazolam. The anticipated study duration is up to nine weeks.~   "
61292|NCT02254928|"~     A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of~     corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian~     stimulation of women with a poor ovarian response undergoing IVF treatments. The main~     objective of this study is comparing the number of oocytes obtained after the follicle~     puncture when using each of these two stimulation protocols. Only poor responders according~     to the Bologna criteria will be recruited for this trial. All participants will undergo two~     stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will~     be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the~     order of application of these protocols will be randomised (crossover clinical trial) in~     each patient.~   "
61293|NCT02254915|"~     A multi-institutional, prospective, randomised, open-label, superiority, comparative,~     active-controlled, phase 3 study. The study will compare Synergo RF-induced~     hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus~     Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and~     high-risk NMIBC, and will evaluate recurrence and progression rate over two years of~     follow-up.~   "
61294|NCT02254902|"~     There is a significant need for culturally adapted and effective health education programs~     to address rising rates of obesity and chronic disease concerns for refugee communities.~     Physical activity has been identified as an important prevention tool to prevent numerous~     chronic health conditions. This research tests the feasibility and acceptability of a~     culturally adapted physical activity intervention for sedentary adult Somali women. Study~     participants will be randomized to a 3-month physical activity program or a wait-list~     control group. The primary outcome is increases in physical activity between baseline and~     the end of the program as measured by pedometer.~   "
61295|NCT02254889|"~     Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric~     neoplasms. Although ESD-related complications such as bleeding and perforation have been~     reported, data is currently lacking on the development of pain, which is one of the most~     common adverse events after ESD. Therefore, in the present study, we investigated the~     incidence and clinicopathologic risk factors of pain after ESD.~   "
61296|NCT02254876|"~     Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5%~     and 84% of patients, often having a strong impact on their well-being and resulting in~     delays achieving rehabilitative objectives.~      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a~     population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with~     respect to pain, spasticity and range of motion.~   "
61297|NCT02254863|"~     The primary objective of the study is to determine the safety and feasibility of intrathecal~     administration of DUOC-01 as an adjunctive therapy in patients with inborn errors of~     metabolism who have evidence of early demyelinating disease in the central nervous system~     (CNS) who are undergoing standard treatment with unrelated umbilical cord blood~     transplantation (UCBT). The secondary objective of the study is to describe the efficacy of~     UCBT with intrathecal administration of DUOC-01 in these patients.~   "
61298|NCT02254850|"~     The purpose of the study was to characterize the action of mesoglycan on vascular~     endothelium through the non-invasive assessment of vascular reactivity humeral artery by~     comparing effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery~     between a group of patients with metabolic syndrome assuming placebo and a group of patient~     with metabolic syndrome assuming mesoglycan; firstly after administration of the~     drug/placebo intramuscularly, and then, in a study of medium-term after oral intake of~     drug/placebo. The selection of patients with metabolic syndrome is related to the fact that~     this syndrome is associated with alterations in endothelial function and a high incidence of~     cardiovascular events. So it is a condition that offers the opportunity to explore the~     hypothesis that the mesoglycan may have a favorable effect on early vascular alterations~     that precede clinical events.~   "
61299|NCT02254837|"~     Japanese post market clinical study of the Zilver PTX device.~   "
61300|NCT02254824|"~     The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in~     hypertensive patients at low/moderate cardiovascular risk.~   "
61301|NCT02254811|"~     Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and~     lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized~     successfully. Endoscopic delivery requires significant health care utilization and~     associated cost. Therefore, it is extremely desirable if FMT can be infused by a non~     invasive modality, which would significantly reduce patient discomfort, procedure related~     risks and health care costs, while offering similar efficacy to colonoscopic delivery in the~     range of 90%.~   "
61302|NCT02254798|"~     Validation of already described biomarkers on acute GVHD prediction and severity Fecal~     calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha,~     HGF~   "
61303|NCT02254785|"~     The purpose of this study is to assess and compare the clinical benefit rate in patients~     with metastatic castrate-resistant prostate cancer and poor prognostic factors treated with~     cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to~     determine which treatment is most active in this population. Clinical benefit rate is~     defined as PSA or measurable radiological response of any duration or stable disease for >~     or equal to 12 weeks, in the absence of other indicators of progression.~      There is option to cross-over onto the other arm if the patient progresses.~   "
61304|NCT02254772|"~     This phase I/II trial studies the side effects and best dose of ipilimumab in combination~     with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients~     with low-grade B-cell lymphoma that has returned. Monoclonal antibodies, such as ipilimumab,~     may block cancer growth in different ways by targeting certain cells. Biological therapies,~     such as TLR9 agonist SD-101, use substances made from living organisms that may stimulate or~     suppress the immune system in different ways and stop cancer cells from growing. Radiation~     therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving ipilimumab in~     combination with TLR9 agonist SD-101 and radiation therapy may be a better treatment for~     B-cell lymphoma.~   "
61500|NCT02252198|"~     Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem~     Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF~     assay using a gold standard of four cultures~   "
61306|NCT02254746|"~     The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation~     Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment~     is the irradiation of the entire prostate gland with or without seminal vesicles accompanied~     or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use~     of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and~     highly efficient outpatient therapy.~   "
61307|NCT02254733|"~     This project is an effectiveness trial comparing two psychosocial treatments for~     schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills~     Training (CBSST) v. ACT, alone.~   "
61308|NCT02254720|"~     Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses~     of BEA 2180 BR; additional exploration of metabolism following inhalation~   "
61309|NCT02254707|"~     To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg,~     40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941~     ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine~     (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection~   "
61310|NCT02254694|"~     The purpose of this study is to investigate the influence of high heeled shoes on the~     sagittal balance of the spine and the whole body.~      The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the~     cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a~     posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity.~     This would be an explanation for the increased prevalence of back pain in individuals~     frequently wearing high heels.~      In order to assess these changes, differences in the two following outcome parameters will~     be measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high~     heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .~   "
61311|NCT02254681|"~     The overall goal of this study is to determine the safety and efficacy of combination~     treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy~     for locally advanced mass forming intra-hepatic cholangiocarcinoma.~   "
61312|NCT02254668|"~     Randomized prospective multi-center imaging study which investigates the impact of different~     immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on~     cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal~     intima-thickness will be visualized by optical coherence tomography (OCT) to assess the~     progression of CAV.~   "
61313|NCT02254655|"~     The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on~     carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine~     anti-rheumatic treatment.~   "
61314|NCT02254642|"~     Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular~     complications, essentially due to the aortic clamping. Ischemic preconditioning can be~     useful in order to decrease these complications. The investigators would like to use an~     ischemic preconditioning protocol during open surgery of aortic aneurysm in order to~     decrease these complications.~   "
61315|NCT02254629|"~     the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the~     fecal microbiota of the patients in a more robust manner .~   "
61316|NCT02254616|"~     Contemporary behavior interventions focused on upper limb training such as robotic-assisted~     training and constraint-induced movement therapy have been proven to promote motor recovery.~     However, the improvement is often of limited in practical significance. Mirror therapy (MT)~     and transcranial direct current stimulation (tDCS) on brain based on similar principle of~     utilizing brain plasticity have shown benefits in promoting motor function recovery and are~     particularly easy to apply in different settings. tDCS activates a bulk of neural circuits~     in a non-specific way, coupling tDCS with MT could steer plastic process toward a functional~     direction. However, current evidence is insufficient to support the efficacy of tDCS as an~     adjuvant to upper limb training, and long-term effect has yet to be explored.~      Cortical stimulation clearly has its role in stroke rehabilitation. However, current~     evidence is insufficient to support the efficacy of tDCS as an adjuvant to MT, and long-term~     effect has yet to be explored. Therefore, this randomized clinical trial will aim to examine~     (1) the beneficial effects of hybrid therapy (i.e., MT with tDCS) on health-related outcomes~     in patients with chronic stroke; (2) the long-term benefits of the hybrid therapy on~     activity participation at 6-month follow-up; (3) the underlying mechanisms of the hybrid~     therapy on motor control and brain organization; (4) the correlations between brain~     excitability patterns and movement kinematics/health-related outcomes. Accordingly, we will~     compare the hybrid therapy vs MT with sham tDCS vs MT vs conventional intervention (CI) on~     motor performance, daily function, and activity participation. We will also examine~     underlying mechanisms by kinematic measures for motor control and fMRI analyses for brain~     reorganization. The MT with sham tDCS group is included to achieve a double-blinded design~     (patient and evaluator blinded) with the MT with real tDCS group. The MT only group is~     included to examine if there exist a placebo effect of the presence of tDCS setting in the~     MT with sham tDCS. The CI group is included to provide a baseline treatment to see if the~     other three therapies induce larger improvements compared to currently standard therapy. We~     hypothesize that (1) the hybrid therapy will induce greater improvements on some~     health-related outcomes compared to other therapies; (2) such benefits will retain at~     6-month follow-up; (3) better motor control and brain reorganization will be found in the~     hybrid therapy than the other therapies; (4) correlations will be found between brain~     activity and movement kinematics/health-related outcomes. This study will be the first to~     investigate effects of the hybrid therapy, MT with tDCS, in chronic stroke. This study is~     unique in examining changes at different levels including motor performance, daily function,~     and activity participation, as well as brain and motor organization. To address the~     inconsistent benefits in daily function outcomes in previous research in MT and tDCS in~     stroke rehabilitation, we will modify the existing treatment protocols and include a~     30-minute functional training into each treatment session in all groups. The result of this~     project might unveil a potentially better hybrid intervention for chronic stroke population~     to choose from, compared to a stand alone therapy such as MT and CI. And the result will~     also provide information on changes in motor control and brain organization which help~     understand the underlying mechanism. The follow-up examination will provide information on~     long term effect at the level of activity participation, which is crucial considering that~     chronic stroke patients are most likely living in community. In addition, we may provide~     critical information on the association between brain activity and movement~     patters/functional outcomes in terms of analyzing the correlation of fMRI data with hand~     kinematics/ health-related outcomes.~   "
61317|NCT02254603|"~     The aim of this study is to examine the effects of combination of acupuncture and ayuveda~     yoga exercise on weight loss for the overweight.~   "
61318|NCT02254590|"~     To evaluate a new endoscopic technique for lumbar spinal canal decompression.~   "
61319|NCT02254577|"~     To determine whether the of vaginal progesterone replacement for frozen embryo transfer~     results in equivalent live birth rates to intramuscular injection progesterone replacement.~   "
61320|NCT02254564|"~     The main objective of this study is to identify unique DNA sequences within the genome of~     human scabies that can be utilized to identify the parasite through PCR.~   "
61321|NCT02254551|"~     The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus~     bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory~     multiple myeloma.~   "
61322|NCT02254538|"~     Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male~     volunteers after oral administration of BILR 355 BS~   "
61323|NCT02254525|"~     The purpose of this study is to study the efficacy of intravenous administration of~     ibuprofen compared to placebo in patients with postoperative pain and evaluate its~     tolerability and safety profile.~   "
61324|NCT02254499|"~     Despite improvements in treatment, a significant part of patients have severe pain following~     knee arthroplasty. Preoperative identification of high-risk patients would allow for an~     intensive individualized analgesic treatment pre- and postoperatively and thus potentially~     in reduced pain acute and chronically.~   "
61325|NCT02254486|"~     This study evaluates the efficacy, safety and tolerability of NER1006 with Trisulfate~     solution in patients requiring bowel cleansing prior to any procedure which requires a clean~     bowel. Half the participants will receive NER1006 and while the other half will receive~     Trisulfate solution.~   "
61326|NCT02254473|"~     This study is looking at the efficacy of a sloped insole in patients with knee~     osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in~     a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,~     decreased use of over the counter analgesics, and a clinically important improvement in the~     Womac pain and stiffness scale.~   "
61327|NCT02254460|"~     The present study supplements iron as part of multiple micro-nutrient supplementation to~     demonstrate that intake of a micronutrient fortified powder in milk helps increase the~     uptake of key micronutrients like iron due to unique nature of the given matrix, as compared~     to intake of iron alone in milk.~   "
61392|NCT02253615|"~     The latest randomized controlled trials and systematic reviews of resistance training~     performed by older adults reported that the systematic use of exercise in machines improves~     muscle strength and power, functional abilities, body mass and body balance. However, the~     effect of resistance training with elastic tubes exercises have not been studied in all the~     variables described above. The objective of this study is to analyze the effects of elastic~     tubes exercises on muscle mass, muscle strength, functional performance and postural control~     in elderly untrained.~   "
61328|NCT02254447|"~     This study will investigate the relative bioavailability of two candidate tablet~     formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the~     reference product ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects.~     This is an open-label, randomized, single dose, three-way crossover, six sequence study~     enrolling 18 healthy human subjects to ensure at least 14 subjects complete the study as~     planned. Each subject enrolled will participate in all three treatment periods and will be~     assigned to one of the six treatment sequences, in accordance with the randomization~     schedule. The treatment periods will be separated by a washout period of at least 7 days and~     no more than 14 days between dosing occasions. A follow up visit will be conducted 14-21~     days post last dosing. ATACAND is a registered trademark of the AstraZeneca group of~     companies.~   "
61329|NCT02254434|"~     This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in~     Mexican healthy volunteers under fasting conditions. The study will be an open label, single~     dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged~     between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0~     kg/meter (m)^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered~     trademark of the GSK group of companies.~   "
61330|NCT02254421|"~     This study will evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral~     load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an~     acute RSV lower respiratory tract infection (LRTI), the effect of presatovir on being free~     of any supplemental oxygen, and rates of respiratory failure and all-cause mortality, and~     pharmacokinetics (PK), safety, and tolerability of presatovir.~   "
61331|NCT02254408|"~     This study will evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral~     load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an~     acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development~     of lower respiratory tract complication, being free of any supplemental oxygen progression~     to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.~   "
61332|NCT02254395|"~     The purpose of this clinical study is to verify the long term effecacy and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with obesity.~   "
61333|NCT02254382|"~     This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants~     with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV~     device; therapy group). The trial will run for 6 months, after which change in~     echocardiographic parameters of diastolic left ventricular function, sleep and quality of~     life parameters will be evaluated.~   "
61334|NCT02254369|"~     The primary objective of the study is to assess the safety and tolerability of single oral~     doses of GC021109 when administered to healthy adult subjects.~   "
61335|NCT02254356|"~     Japanese post market clinical study of the Zilver Flex device.~   "
61336|NCT02254343|"~     The purpose of this study is to compare the training effects of robot-assisted therapy focus~     on proximal part, distal part, or total segment of upper extremity, respectively.~   "
61337|NCT02254330|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
61338|NCT02254317|"~     The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on~     glucose control in people with impaired glucose tolerance (IGT).~   "
61339|NCT02254304|"~     This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon~     beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in~     subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).~   "
61340|NCT02254291|"~     This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing~     of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy~     during 30 weeks of treatment in Japanese subjects with type 2 diabetes.~   "
61341|NCT02254278|"~     This randomized phase II trial studies the side effects and how well modestly reduced-dose~     intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating~     patients with oropharyngeal cancer that has spread to other places in the body (advanced).~     Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is~     not yet known whether IMRT is more effective with or without cisplatin in treating patients~     with oropharyngeal cancer.~   "
61342|NCT02254265|"~     This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose~     concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo~     (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).~   "
61343|NCT02254252|"~     Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed~     opacification of epicardial arteries in the absence of significant arterial narrowing and~     blockade. Endothelial dysfunction at the level of microarteries have been proposed as the~     main pathological mechanism in this regard. Available evidence suggest that standard~     anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might~     not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It~     is hypothesized that anti-angina medications which exert vasodilatory effects in large~     coronary arteries as well as small dividing branches might be superior to nitroglycerin in~     amelioration of angina symptoms. The present randomized clinical trial was thus designed and~     conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina~     medication with effects on both large and small coronary vessels) with nitroglycerin in a~     group of patients with slow coronary flow presented with frequent angina episodes.~   "
61443|NCT02252939|"~     The investigators are doing this research study to discover factors, such as job, hobbies,~     or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb~     arthrosis is one of the most common kinds of arthritis. About 116 people will take part in~     this research study at Massachusetts General Hospital (MGH).~   "
61501|NCT02252185|"~     The primary objective of this study is to demonstrate that the efficacy and safety of Spine~     fusion system manufactured in China is no inferior than imported product.~   "
61344|NCT02254239|"~     This phase I trial studies the side effects and the best dose of everolimus when given~     together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has come~     back (relapsed) or is not responding to treatment (refractory). Everolimus may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab~     vedotin may interfere with the ability of cancer cells to grow and spread by binding to a~     protein on the surface of cancer cells and then releasing a cancer-killing substance to~     them. Giving everolimus together with brentuximab vedotin may be a better treatment for~     Hodgkin lymphoma.~   "
61345|NCT02254226|"~     1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg~          Serevent ® MDI with sufficient precision so that in combination with a second trial it~          can be demonstrated that the systemic drug exposure of a new formulation of salmeterol~          xinafoate is not superior to that of Serevent ® MDI~        2. To test a system of ordered null hypotheses regarding the exposure of two dose levels~          of Serevent ® Diskus ® and Serevent ® MDI~        3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg~          Serevent ® Diskus ®~   "
61346|NCT02254213|"~     The main objective is to evaluate the stability of EEG features on an individual level.~   "
61347|NCT02254200|"~     Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to~     be linked with an impaired ability to oxidize lipids, particularly in class III obese~     individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy~     to improve insulin sensitivity and to reduce the risk of type 2 diabetes.~      This study aimed to compare the effects of two different 2-wk-long training modalities~     [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted~     high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and~     III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of~     rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity~     would be improved to a greater extent when adapted HIIT compared to Fatmax training.~   "
61348|NCT02254187|"~     The objective of this study is to investigate if the systemic drug exposure of at least 25~     μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and~     administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to~     investigate safety and tolerability of salmeterol presented as inhalation powder in PE~     capsules and administered via HandiHaler® 2~   "
61349|NCT02254174|"~     Assessment of the relative bioavailability of a fixed dose combination of tiotropium and~     salmeterol compared to a free dose combination of the marketed products of tiotropium and~     salmeterol (Spiriva® and Serevent® Diskus®).~      Assessment of the relative bioavailability of a fixed dose combination of tiotropium and~     salmeterol compared to tiotropium and salmeterol administered as individual mono substances~     from the marketed products.~      Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol~     in a PE (Polyethylene) capsule administered via the HandiHaler® 2~   "
61350|NCT02254161|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 1181181 in healthy young male and elderly male and female volunteers following oral~     administration of repeated rising doses of BI 1181181, given once daily over 10 days.~     Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics~     (PD) of BI 1181181.~   "
61351|NCT02254148|"~     To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein~     (P-gp) probe drugs as a means of predicting drug-drug interactions.~   "
61352|NCT02254135|"~     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral~     doses of BEA 2180 BR~   "
61353|NCT02254122|"~     Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics~     (PK) of BEA 2180 BR~   "
61354|NCT02254109|"~     Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese~     healthy volunteers~   "
61355|NCT02254096|"~     The objectives are:~        1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising~          single doses.~        2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT~          1696 BS after grapefruit juice.~        3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g~          fat and high caloric breakfast.~   "
61356|NCT02254083|"~     Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8~     mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood~     coagulation parameters~   "
61357|NCT02254070|"~     To assess the influence of different degrees of renal impairment on safety, tolerability,~     pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose~     infusion over 30 minutes in comparison to a normal renal function~   "
61358|NCT02254057|"~     Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3,~     1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous~     infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters~   "
61359|NCT02254044|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
61360|NCT02254031|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
61361|NCT02254018|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
61362|NCT02254005|"~     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
61363|NCT02253992|"~     The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and~     tolerable when they are given together.~   "
61364|NCT02253979|"~     Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The~     DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after~     intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the~     tube's right side port. This study was designed to compare the VivaSightTM DL to the~     standard DLT.~   "
61763|NCT02248779|"~     The purpose of this study is to better understand the risk factors and causes of diabetes in~     people who received radiation to the abdomen as children. The investigators hope this~     information will allow them to improve how they screen people at risk for diabetes and how~     they treat patients in the future.~   "
61365|NCT02253966|"~     Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for~     osteoarthrosis, a substantial part of patients still have severe acute pain after surgery.~     It has been suggested that preoperative degree of intraarticular inflammation is associated~     to postoperative degree of pain and level of function. Furthermore it is known, that~     patients with preoperative inflammation have hyperalgesia and severe movement related pain.~      The aim of this study is to investigate the effect of a preoperative intraarticular~     injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee~     arthroplasty in patients with signs of severe pre-operative inflammation and pain.~   "
61366|NCT02253953|"~     Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of~     a single dose of BILR 355 BS dissolved in PEG 400~   "
61367|NCT02253940|"~     Study to determine the single dose, relative BA of new SDS-containing formulations of BILR~     355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet~     formulation (50 mg tablet)~   "
61368|NCT02253927|"~     The primary objective was to explore the relative bioavailability of increasing doses of~     BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination~     with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing~     doses.~      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355~     (SDS)~   "
61369|NCT02253914|"~     Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low~     dose ritonavir in healthy male volunteers.~   "
61370|NCT02253901|"~     Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and~     TRUVADA on BILR 355~   "
61371|NCT02253888|"~     The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg~     self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled~     temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250~     mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C~   "
61372|NCT02253875|"~     Study to determine the effects of multiple-dose omeprazole on the single-dose~     pharmacokinetics of tipranavir and ritonavir~   "
61373|NCT02253862|"~     Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200~     mg on the single-dose pharmacokinetics of tadalafil 10 mg~   "
61374|NCT02253849|"~     Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg~     twice daily, depending on tolerability, and administered alone and in combination with~     tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200~     mg twice-daily)~   "
61375|NCT02253836|"~     Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the~     single-dose and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with~     Ritonavir (100 mg). To investigate the effects of single-dose and steady-state Atazanavir~     (300 mg) on the steady-state pharmacokinetics of Tipranavir and Ritonavir.~   "
61376|NCT02253823|"~     The objective of this study was to characterize the effects of two dose combinations of~     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily~     and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily~   "
61377|NCT02253810|"~     The goal of this randomized controlled, double-blinded trial is to assess the efficacy of~     intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients~     undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.~     The investigators hypothesize that tranexamic acid will be more effective than placebo~     (normal saline solution) in reducing blood loss and transfusion after periacetabular~     osteotomy.~   "
61378|NCT02253797|"~     Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion~     and mass balance of parent compound and radioactivity at steady-state; to isolate, identify~     and quantify major metabolites of tipranavir in plasma, urine and feces~   "
61379|NCT02253784|"~     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the~     duration of a block in total knee arthroplasty. The aim of this study is to determine~     whether this is a systemic or local effect.~   "
61380|NCT02253771|"~     The purpose of this study is to determine whether shockwave therapy is more effective in the~     treatment of unspecific acute low back pain than sham therapy.~      60 patients with acute low back pain will be recruited to a single-blinded, randomized,~     placebo-controlled trial. They are randomized to receive either shockwave therapy or sham~     treatment by a identically looking device for 4 weeks, twice a week. Additionally patients~     receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if~     necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every~     week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The~     clinical outcome will be primarily measured by pain intensity using a visual analogue scale.~     Secondary outcome measures are Oswestry Disability Index, Beck`s Pain Depression Scale,~     Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the~     difference in change of scores between groups using one-way t-test.~   "
61388|NCT02253667|"~     The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and~     90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.~      Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide,~     Heliox 28 and oxygen.~      Conventional oxygen supplementation is often used in these patients, but it may be~     inadequate, especially if they require high flows (from 30L/min to 120L/min in acute~     respiratory failure).~      High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen~     system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which~     generates the gas flow rate up to 55 L/min and a heated humidification system. This~     technology may have an important role in reducing respiratory distress in do-not-intubate~     patients.~      Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing~     rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen~     concentration; a better matching between patient's inspiratory demand and oxygen flow;~     generation of a certain level of positive pressure (PEEP) contributing to the pulmonary~     distending pressure and recruitment; improvement of lung and airway mucociliary clearance~     due to the heated and humidified oxygen; and patient's comfort because of the nasal~     interface allowing feeding and speech.~      The investigators hypothesize that patients supported with HFONC need less opioids to~     decrease dyspnoea.~   "
61381|NCT02253758|"~     Emergence from sedation involves an increase in both the level of consciousness and arousal.~     Some insight to the neural core of consciousness was gained in the recent past. Our research~     objective is to characterize for the first time the spatiotemporal mobilization of the~     ascending reticular activating system during emergence from sedation; stated otherwise - to~     capture the neural core of arousal.~      To achieve this objective we plan to utilize the advanced imaging modality of EEG-fMRI. In~     short, volunteers will be placed in the MRI. Following baseline recordings they will be~     sedated with a continuous drip of propofol, titrated to deep sedation. Once in that sedation~     level, propofol administration will cease until emerging to an awake-calm/light sedation.~      Continuous EEG recordings and fMRI scans will be taken, both task specific (auditory~     oddball) and resting-fMRI. Analyses will focus (but will not be restricted to) on~     constituents of the ascending reticular activating system.~      The expected advances of this proposal are:~        1. Emergence from sedation (and anesthesia) is one of the critical stages and least~          elucidated area in the practice of anesthesia. Delayed awakening of varying degree is~          not uncommon after anesthesia and may have a number of different causes, individual or~          combined, which may be both drug or non-drug related, thus causing a diagnostic~          dilemma. Eventually - better insight into this subject will lead to better clinical~          practice and better understanding why patients emerge in such a diverse and sometimes~          unexpected manner.~        2. Knowledge of the internal structure underlying arousal from anesthesia will help~          develop / upgrade brain monitors that could tell the anesthesiologist the patient's~          level of consciousness and prediction of arousal.~        3. A detailed reproducible mapping of the arousal process may serve as the core of a drug~          screening platform for drugs that may expedite patient arousal.~        4. Elucidation of the arousal paradigm from sedation will enhance our knowledge of~          physiological sleep.~      Research hypothesis~      Return of consciousness is a complex phenomenon comprising of interplay between the cortex~     and deeper brain structures. We hypothesize that the activation signature is conserved and~     similar between subjects. Furthermore, we hypothesize that inter-subject variability will~     arise mainly in the time domain, as evident from the clinical observation of variable time~     to emergence in different patients.~   "
61382|NCT02253745|"~     The purpose of this research study is to evaluate the safety, tolerability, effectiveness,~     and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.~     Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and~     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood~     samples will be taken throughout the study for PK analysis.~   "
61383|NCT02253732|"~     The purpose of this study is to determine specific changes in muscle secretory profile~     (myokines, miRNA) in association with neurodegenerative disease progression and metabolic~     dysfunction. Next the investigators would like to determine the shift in the muscle~     secretory activity induced by regular exercise intervention, which the investigators think~     could be translated into the beneficial changes in clinical phenotypes, determined by~     neuroimaging, cognitive function tests and metabolic phenotyping.~   "
61384|NCT02253719|"~     The prevalence of cervical neoplasia in Cambodia is not known. There are no screening~     programs in place. The investigators plan on introducing a screening program based on WHO~     criteria and utilizing visualization with acetic acid. Patients who are positive will be~     offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and~     hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of~     whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).~   "
61385|NCT02253706|"~     In general bronchoscopy is a safe procedure with low rate of complications. Indeed,~     contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is~     the case of preexisting decreased blood oxygen levels which may be present in patients~     requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen~     drops oxygen supplementation is recommended.~      The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation~     obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula~     during flexible bronchoscopy.~      Consecutive patients referred by their treating physician for bronchoscopy will be offered~     to take part in the study. Those who wish to participate and give their consent will be~     randomly assigned into one of two treatment groups (supplemental oxygen given via low flow~     nasal cannula or via high flow nasal cannula).~      Assignment to either treatment arm will not affect in any way the intended purpose of the~     bronchoscopy. All patients will be closely monitored during the procedure and 2 hours~     following its completion. Monitoring will be conducted, using strictly non-invasive~     measures.~   "
61386|NCT02253693|"~     Research Question: Does an specific and pre-defined physical exercise prescribed by a~     specialist provide any benefit on haemophilic arthropathy, the quality of life or the~     physical condition of patients with haemophilia A and haemophilic arthropathy? Does~     adherence to physical exercise improve when monitoring patients with an accelerometer? Do~     compliant patients find higher benefit on haemophilic arthropathy, quality of life or the~     physical condition than non-compliant patients?~      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a~     prescribed and specific physical exercise monitored by an accelerometer is producing any~     change in the following domains: progress of haemophilic arthropathy; health-related quality~     of life; physical condition.~      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with~     haemophilia A and haemophilic arthropathy by means of accelerometry, and asses if compliant~     patients achieve higher improvement in these 3 domains than non-complaint patients.~   "
61387|NCT02253680|"~     The use of compression bandages in elective orthopaedic knee surgery is well regarded,~     however, there is a lack of robust, well-designed evidence to support this.~      The aim is to determine the feasibility of conducting a randomised control trial comparing~     the use of a compression bandage worn post-operatively for 24 hours after elective total~     knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).~   "
61389|NCT02253654|"~     The purpose of this study is to compare two different dosing methods of epoetin alfa and~     their effectiveness in maintaining a Hemoglobin level between 10.0 to 11.0 g/dL.~      Study Hypothesis: An alternative dosing method to the United States package insert specified~     method can increase the percent of time Hemoglobin is within a prespecified range of 10.0~     to11.0 g/dL.~   "
61390|NCT02253641|"~     This study evaluates the efficacy of a stress-focused tailored weight loss intervention~     compared to a standard weight loss intervention on weight loss in severely obese (BMI >~     40.0) African American women.~   "
61391|NCT02253628|"~     This study investigated the acute effect of the consumption of four different kinds of~     coffee (hot and cold instant coffee, cold espresso and hot filter coffee) with the same~     caffeine content on salivary gastrin, cortisol and alpha-amylase concentrations, on~     self-reported gastrointestinal symptoms and on psychometric assessments in healthy~     individuals.~   "
61764|NCT02248766|"~     The aim of this dispensing study is to evaluate the clinical performance of existing wearers~     of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.~   "
61393|NCT02253602|"~     The current standard treatment of resectable esophageal cancer consists of neoadjuvant~     chemoradiation followed by resection. However, some patients develop recurrent disease~     despite chemoradiation and additional (systemic) treatment might have been indicated. Other~     patients show a (nearly) complete response after chemoradiation and could possibly have been~     treated with a less extensive treatment regimen. In patients without a threatened~     circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could~     possibly be omitted.~      Better stratification of patients with esophageal cancer is therefore urgently needed.~     Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative~     information on tumor biology and may prove to be a useful non-invasive tool for this~     purpose. In this project, ultra-small superparamagnetic particles of iron oxide (USPIO)~     enhanced MRI using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2* MRI will be~     developed, both in terms of improvement of acquisition and data processing techniques.~   "
61394|NCT02253589|"~     Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to~     a one-session brief intervention or waiting list. Reductions in khat use will be measured~     from pre- to post-assessment which will be one month apart. After one month, the waiting~     list will receive the same intervention.~   "
61395|NCT02253576|"~     Study Design: This randomized, double blind, controlled, multi-centre study will occur in~     the Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics~     (collectively ED) of 3 General Hospitals in Ontario and 1 in British Columbia.~   "
61396|NCT02253563|"~     Comparison of resistance training versus balance training to improve postural control in~     patients with Parkinson's Disease~   "
61397|NCT02253550|"~     This study will look at the safety and efficacy of 8 week and 12 week treatment with~     Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic~     hepatitis C genotype 4.~   "
61398|NCT02253537|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
61399|NCT02253524|"~     -  Vertigo complaint is one of the common cause of patients who applied to emergency~          services.~        -  Patients who have applied to emergency services with vertigo complaint mostly have~          nausea as an additionally symptom to this complaint and anti-emetic agents can be used~          in their treatments very often.~        -  The investigators purpose is to investigate the advantages of Dimenhydrinate and~          metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by~          nausea~   "
61400|NCT02253511|"~     Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different~     regions of the world. The 5-year risk of recurrence of HCC after resection has been reported~     to be as high as 70%. It has been proposed that best way to reduce recurrence is to search~     for improved adjuvant therapies. Especially for some postoperative patients who were~     identified with the risk factors for recurrence, several adjuvant therapies were often used,~     including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for~     toxicity reduction and enhancing the efficacy have been investigated in the treatment of~     HCC. Cidan capsules are a formula containing more than ten types of plant extracts, and has~     been clinically used for >10 years as a safe and nontoxic antitumor drug. However, the safy~     and efficacy of preventive therapy is still not clear. In this prospective control study, we~     enroll such HCC patients experienced operation and were identifed with high risk of~     recurrence. After a preventive TACE, the eligible patients were divided into two groups. One~     group will accept Cidan therapy and another will not. Under a basis of large sample, the~     safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and~     analysed.~   "
61401|NCT02253498|"~     The purpose of this clinical study is to verify the long term effectiveness and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with cognitive, behavioral, and functional disability of~     Tourette Syndrome.~   "
61402|NCT02253485|"~     Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV)~     infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born~     to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is~     evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg~     positive mothers with high serum HBV DNA loads.~   "
61403|NCT02253472|"~     The purpose of this clinical study is To verify the long term effectiveness and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with cognitive, behavioral, and functional disability of~     Obsessive-Compulsive Disorder.~   "
61404|NCT02253459|"~     The purpose of this study is to determine whether UTD1 Injection in combination with~     capecitabine is effective in the treatment of advanced metastatic breast cancer using~     capecitabine as a control.~   "
61405|NCT02253446|"~     -  Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians~          in Turkey for the treatment of patients with Primary Dysmenorrhea.~        -  The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's~          pain reduction dysmenorrhea in emergency department (ED) adults.~        -  The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours~          after discharge.~   "
61406|NCT02253433|"~     The purpose of this study is to improve the health of African-American adults who have~     poorly controlled asthma. The study will compare a home-based exposure reduction and asthma~     control intervention to enhanced in-clinic care that includes a standard clinical~     appointment as well as information from a detailed exposure history, asthma education,~     assessment for allergies, and a customized asthma self-management plan developed using~     motivational interviewing. The interventional group receives enhanced in-clinic care, as~     well as a customized home-based environmental exposure assessment and multicomponent~     exposure reduction and asthma control intervention (five home visits over approximately 12~     months).~   "
61444|NCT02252926|"~     Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and~     painful adverse effect caused by the radio therapy and/or chemo therapy patients with head~     and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the~     current treatment with opioids is not sufficient and can cause adverse effects.~      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce~     the oral pain caused by mucositis compared with the current standard treatment.~   "
61407|NCT02253420|"~     In summary, copanlisib is metabolized mainly by the CYP3A4 enzyme, thus a study to evaluate~     potential DDI (drug-drug interaction) of copanlisib with concomitant CYP3A4 modulators such~     as Itraconazole (CYP3A4 inhibitor) and Rifampin (CYP3A4 inducer) is necessary. With this~     regard this study aims to evaluate the effect of Itraconazole or Rifampin on the absorbtion,~     distribution, metabolization and elimination of Copanlisib (BAY80-6946) . In addition, as~     parameters of cardiovascular safety , the effect of copanlisib on the heart's ability to~     pump blood and to rule out copanlisib's potential for causing a specific type of~     life-threatening arrhythmia, QT/QTc intervals and left ventricular ejection fraction will be~     evaluated.~   "
61408|NCT02253407|"~     This is a study planned to determine and compare immunogenicity and reactogenicity of MMR~     vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or~     disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.~   "
61409|NCT02253394|"~     The purpose of this study is to find out if spironolactone added to ambrisentan for~     Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find~     out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart~     pumps every minute), right ventricle function and quality of life.~   "
61410|NCT02253381|"~     Hypotension is the most common complications after spinal anesthesia especially in pregnant~     patients who undergoing cesarean section. Position during spinal anesthesia may be altering~     the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena~     cava that may decrease venous return and cardiac output. This leads to hypotension.The~     hypothesis is the right lateral position during spinal anesthesia in pregnant women will be~     had hemodynamic changing more than the left lateral position. This objective is to compare~     hemodynamic change between left and right lateral position during spinal anesthesia in~     pregnant women undergoing cesarean section.~   "
61411|NCT02253368|"~     Bedtimes and wake-up times vary from person to person. The aim of this research is to~     examine the associations between sleep habits and metabolism in healthy people. In this~     study, the investigators will collect information on sleep-wake habits and how the body uses~     energy.~   "
61412|NCT02253355|"~     Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with~     Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging~     (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective~     evidence for the mechanism of Acupuncture on depression.~   "
61413|NCT02253342|"~     This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar~     macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in~     healthy adult subjects.~   "
61414|NCT02253329|"~     In the present study, the effect of a bolus of intrinsically labeled milk directly after~     one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:~     during the day and prior to sleep~   "
61415|NCT02253316|"~     The purpose of this research study is to evaluate a treatment regimen called IRD which will~     be given to participants after their stem cell transplant in an effort to help prolong the~     amount of time the participants are disease-free after transplant. IRD is a three-drug~     regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone.~     After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy~     either with ixazomib or lenalidomide.~   "
61416|NCT02253303|"~     The purpose of this study is to evaluate the midline extraction incision in patients with~     colon cancer. A prospective randomized controlled trial is conducted to compare midline~     extraction incision with off-midline extraction incision.~   "
61417|NCT02253290|"~     This project is a retrospective and prospective investigation of neuropsychological and~     psychosocial development of children with a neuromuscular disease.~   "
61418|NCT02253277|"~     In this study it is the rationale to evaluate the safety and tolerability of the combined~     administration of nilotinib and increasing dose of ruxolitinib in patients with chronic~     myeloid leukemia and patients with Philadelphia positive acute lymphoblastic leukemia.~   "
61419|NCT02253264|"~     Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous~     system that is characterized pathologically by focal demyelinating lesions in the brain~     parenchyma. Meningeal inflammation in MS was first noted in 2004. Ectopic lymphoid follicles~     were described in the meninges of patients with secondary progressive MS (SPMS) and were~     thought to correlate with cortical lesions and atrophy (a surrogate marker for disability).~     Subsequently, inflammation in the meninges has been described in primary progressive MS~     (PPMS) as well as early relapsing MS.~      The ectopic lymphoid follicles are composed of B-cells, T follicular helper cells and~     follicular dendritic cells. Rituximab is a monoclonal antibody against CD-20 (a B-cell~     marker) that is FDA approved for the treatment of various lymphomas. Intrathecal (IT)~     rituximab administration has been used in central nervous system (CNS) lymphoma to achieve~     greater cerebrospinal fluid (CSF) concentrations of rituximab. In MS, IT administration of~     rituximab could lead to higher CSF rituximab levels resulting in the disruption of meningeal~     ectopic lymphoid follicles, ultimately reducing cortical lesions and possibly disease~     progression.~      We hypothesize that IT rituximab therapy in patients with progressive forms of MS could~     disrupt ectopic lymphoid follicles in the meninges and thus slow progression of the disease,~     which is particularly important because there exist no FDA-approved therapies for~     progressive MS. We hypothesize that using magnetic resonance imaging (MRI) to identify those~     with enhancing meningeal lesions will provide a biomarker to select patients who might be~     most likely to respond to IT rituximab and to use these lesions to monitor therapeutic~     response.~      The primary aim of this study is to assess the safety of intrathecal administration of~     rituximab in patients with progressive MS. The secondary aims are to evaluate if IT~     rituximab leads to a decrease in the quantity of meningeal lesions on MRI or to changes in~     biomarkers of inflammatory activity or neuronal injury in the CSF.~   "
61420|NCT02253251|"~     The investigators will recruit and enroll individuals that may have the KRAS-variant or~     other microRNA binding site mutations to join registry studies. The investigators will allow~     individuals to obtain their results through a physician at the completion of the studies.~     The investigators current focus is breast cancer.~   "
61421|NCT02253238|"~     The goal of this research study is to learn if home-use of devices to identify dehydration~     risk, when added to standard care, will help to lower hospitalizations and emergency room~     visits (and related costs) in patients with head and neck cancer.~      CYCORE is a software-based system that enables comprehensive collection, storage and~     analysis of information related to cancer research and clinical care. In this study, those~     in the CYCORE group use devices at home to measure their dehydration risk. This information~     is monitored by their clinicians. Those in the standard care group complete health based~     surveys, as do those in the CYCORE group.~   "
61422|NCT02253225|"~     The investigators propose to examine both resting state activity and functional activity~     during rumination and during self-processing to study the relationship between neural~     correlates of rumination/self-focus and self-processing in major depression and bipolar~     disorder.~   "
61423|NCT02253212|"~     PURPOSE: The purpose of this study is to determine whether transient opening of the~     blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device~     is safely tolerated in patients with recurrent glioblastoma immediately before systemic~     delivery of carboplatin-based chemotherapy.~      STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior~     to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of~     the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to~     carboplatin-based chemotherapy and increase progression-free and overall survival in~     patients with recurrent glioblastoma.~   "
61424|NCT02253199|"~     Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.~     We performed a up-down sequential allocation study to determine the ED50 for rescue sedation~     following sedation failures in children and to investigate age-related differences in the~     rescue sedation with dexmedetomidine.~   "
61425|NCT02253186|"~     The objective of the study is to assess the effect of a new Armsleeve, worn during the night~     during maintenance phase of upper limb lymphoedema treatment in combination with Day-time~     usual lymphology hosiery.~   "
61426|NCT02253173|"~     This study will assess the safety and efficacy of a new formulation of vaginal estradiol for~     the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.~   "
61427|NCT02253160|"~     The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate~     the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared~     to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject~     safety will be evaluated beginning with mobilization, throughout the collection procedure~     and for the day following the last collection.~   "
61428|NCT02253134|"~     The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment)~     of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of~     suspected arrhythmic origin, within 30 days before enrollment.~   "
61429|NCT02253121|"~     Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid~     pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of~     COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced~     hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be~     randomized to treatment of dapagliflozin or placebo orally, once daily.~      Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of~     hypoglycemia will be compared between dapagliflozin group and placebo group.~   "
61430|NCT02253108|"~     The purpose of this study is to compare early vessel healing after implantation of SYNERGY~     drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.~   "
61431|NCT02253095|"~     Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,~     albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian~     children.~   "
61432|NCT02253082|"~     Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for~     thoracic aortic dissections - a randomized, controlled, single-blinded~     investigator-initiated pilot trial~   "
61433|NCT02253069|"~     To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in~     full-thickness surgical wounds in dermatologic surgery in order to minimise the development~     of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and~     postoperatively will be examined in order to understand the pathogenesis of surgical site~     infections better.~   "
61434|NCT02253056|"~     The aim of this pilot study is to evaluate the effects of one regular fasting day per week~     over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.~   "
61435|NCT02253043|"~     Purpose: The purpose of this clinical study is to verify the long term effectiveness and~     safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co.,~     Ltd. as a treatment option for patients with cognitive, behavioral, and functional~     disability of Alzheimer's disease.~   "
61436|NCT02253030|"~     The primary goals of this study are to use optical coherence tomography (OCT) angiography~     (blood vessel mapping) to:~        1. diagnose the presence of new blood vessels in wet age-related macular degeneration~          (AMD)~        2. evaluate patients undergoing treatment for wet AMD~        3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.~   "
61437|NCT02253017|"~     The purpose of this observational study is to assess the therapeutic strategies in the~     treatment of pediatric cataracts.~   "
61438|NCT02253004|"~     In a double blind placebo-controlled cross-over study the effect of cilostazol on aura~     induction and endothelial response is tested in patient with migraine with aura.~   "
61439|NCT02252991|"~     This trial will measure the fatigue in breast cancer patients.~      Two groups of patients will be realised:~        -  Arm A: Physical activity during treatment~        -  Arm B: No physical activity during treatment but after~      The aim of the study is to decrease fatigue, with adequate physical activity, in primary~     breast cancer patients who receive a treatment for their pathology.~   "
61440|NCT02252978|"~     This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in~     diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for~     examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat~     infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy~     may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial~     infection of the prostate gland and may or may not affect the detection rate of prostate~     cancer.~   "
61441|NCT02252965|"~     This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter~     trial in which metformin extended release (XR) will be compared with metformin immediate~     release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed~     subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to~     10.0 percent (%).~   "
61442|NCT02252952|"~     The purpose of this study is to investigate the effects of consumption of sugar sweetened~     and diet beverages on overall fat mass and the fat mass of various tissues implicated in the~     dysregulation of glucose metabolism. In addition, hypothalamic activity will also be~     investigated after acute exposure to sugar sweetened and diet beverages, and again after 6~     months of daily consumption.~   "
61447|NCT02252887|"~     The purpose of this study is to see if a combination of drugs can help to treat breast~     cancer. This is a Phase II study which will test whether this combination of drugs is~     effective and will provide further information on side effects and safety. A standard~     chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2~     receptor. The HER2 receptor is a growth protein on the surface of some breast cancer cells~     that provides messages telling the breast cancer cell to grow. The standard chemotherapy~     will be gemcitabine.. The other two drugs work against HER2. One is called trastuzumab~     (Herceptin) and it is commonly given to women with advanced and early HER2 positive breast~     cancer. The other drug, pertuzumab (Perjeta), is also given to women with advanced HER2~     positive breast cancer. The drugs in this study are each individually approved for the~     treatment of metastatic breast cancer. However, this study is looking at the effectiveness~     of gemcitabine with trastuzumab and pertuzumab when given to women who have advanced HER2~     positive breast cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based~     therapy.~   "
61448|NCT02252874|"~     This project is aimed to find out whether action video games can enhance dynamic visual~     function and improve balance function in the community-dwelling older adults. It is also~     aimed to examine the relationship between dynamic visions and balance functions.~   "
61449|NCT02252861|"~     Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium~     that can induce cerebral vascular events or systemic embolisms. This justifies the~     prescription of anticoagulant therapies in patients with high risk of thromboembolic event.~     Percutaneous left atrial appendage closure is a new interventional strategy for patients~     with high risk of cardiovascular events and a counter-indication for long term treatment~     with anticoagulant agents. However, only few data are available on effectiveness and~     prognosis of patients treated by this new interventional strategy.~      This national database record per-procedure and follow-up data of patients treated by left~     atrial appendage closure.~      This database is strictly observational.~      Percutaneous left atrial appendage closure is performed only for the purpose of patient~     care. No specific intervention is performed specifically for the database. Neither left~     atrial appendage closure procedure nor patient follow up are modified by patient inclusion~     in the database.~   "
61450|NCT02252848|"~     Hypoxic ischemic encephalopathy (HIE) occurs in ~ 2-4/1000 term infants and is a major cause~     of neonatal morbidity and mortality. To date, therapeutic hypothermia started within 6 h of~     birth is the only intervention known to be effective in reducing the morbidity and mortality~     of HIE. Hypothermia does not totally reverse the injury in many infants and is associated~     with side effects that may compromise its effectiveness. Low dose morphine is often used to~     reduce shivering in infants undergoing therapeutic hypothermia, but escalating doses of~     sedatives/analgesics are often required. Escalating doses of opioids and benzodiazepines~     causes respiratory depression and can either cause the need for or prolong mechanical~     ventilation.Agonists to the central a2 - adrenergic receptors are more effective at reducing~     postoperative shivering than opioid receptor agonists and provide analgesia and sedation~     without respiratory depression. The most desirable sedative-analgesic agent used in infants~     with HIE would: (a) have an excellent safety profile, (b) reduce shivering, (c) provide~     adequate analgesia and sedation, (d) cause minimal respiratory depression, (e) preserve~     cerebrovascular autoregulation, and (f) confer neuroprotection.~   "
61451|NCT02252835|"~     The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and~     potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult~     population with gout.~   "
61452|NCT02252822|"~     Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek~     treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of~     disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN~     often go unnoticed by parents and clinicians.~      In order to eliminate the barriers that prevent adolescents from seeking treatment, this~     study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for~     BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and~     acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been~     found to be as effective as specialized treatments, and more cost efficient.~      To remain anonymous and accessible, the self-help approach in this study will be provided in~     a non-guided, or pure format (only online sessions). Studies support that a pure self-help~     methodology is as effective as a guided version.~      Although anonymity may improve accessibility, this study design could also pose challenges~     in areas such as recruitment, treatment completion and obtaining adequate informed consent.~     Therefore, before embarking on a larger randomized control trail, we would like to propose a~     small, non-controlled feasibility study to assess potential issues in these areas.~      Primary hypotheses:~      Recruitment: Based on communication with public health nurses in the high schools we plan to~     recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month~     period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,~     Twitter, Facebook for a total of 5 participants over a 4-month period.~      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we~     hypothesize that approximately 15% of participants will not complete any sessions, and many~     will only complete about half of the sessions.~      Informed consent: Based on information from large randomized control studies in the UK, we~     hypothesize that adolescents will be capable of providing online consent, and that we will~     be able to adequately obtain consent without verbally communicating with participants.~      Secondary hypothesis:~      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner~     will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to~     baseline.~   "
61453|NCT02252809|"~     The main objective of this study is to characterize the biological responses elicited by~     endotoxin inhalation applied to healthy subjects, and to assess the effect of standard~     anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological~     responses.~   "
61454|NCT02252796|"~     This study will help researchers test the safety of hypofractionated dose of radiotherapy~     (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung~     Cancer.~   "
61455|NCT02252783|"~     BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in~     subjects with known or suspected coronary artery disease (CAD) as compared to standard~     nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known~     or suspected CAD subjects.~   "
61456|NCT02252770|"~     This is a study involving a dietary supplement. Patients with argininosuccinic aciduria will~     be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 2~     weeks, and then crossed-over to receive the other treatment for two weeks.~      The investigators expect to see that : 1) Patients with ASA will have a decreased ability~     for their arteries to dilate due to nitric oxide deficiency, 2) Treatment of ASA with the~     nitric oxide supplement will improve the ability of their arteries to dilate, and 3) Through~     the testing of subjects' fibroblasts (cells in connective tissue that produce collagen and~     other fibers), the investigators hope to predict which patients may respond NO~     supplementation.~   "
86231|NCT01928680|"~     It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in~     anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.~   "
61457|NCT02252757|"~     Heart failure is a common cardiovascular problem which is increasing in both prevalence and~     incidence and associated with substantial morbidity and mortality. The management of heart~     failure patients is complex and has become a priority world over. Effective methods to keep~     heart failure patients out of the hospital are essential, both in the interests of the~     patient's health, as well as to reduce the burden on the health care system~   "
61458|NCT02252744|"~     This study will evaluate the prevalence of dry eye disease in patients diagnosed with~     rheumatoid arthritis. No treatment is administered in this study.~   "
61459|NCT02252731|"~     This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics~     (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin~     alone and in combination with multiple doses of FG-4592, and will evaluate the effect of~     multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.~   "
61460|NCT02252718|"~     The aim of this study is to assess interobserver and intraobserver variability of the~     Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating~     in the study it will be assessed using the Amsterdam Stool Scale independently by one of the~     parents and the medical doctor. At the same time a parent will take 2 photos that will be~     independently evaluated by another doctor.~   "
61461|NCT02252705|"~     Prospective multicenter registry including incident patients and prevalent patients which~     pretends to identify clinical characteristics, treatment trends in-hospital and four years~     follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population~     with well characterized Pulmonary Hypertension.~   "
61462|NCT02252692|"~     Phase I study in healthy adult male and female volunteers to compare the bioavailability of~     enalapril administered in orodispersible Minitablets with or without water in comparison to~     the standard galenic tablet formulation of enalapril. The standard pharmacokinetic~     parameters will be calculated from the bioanalytical results for enalapril and enalaprilat~     and compared in a descriptive statistical analysis.~   "
61463|NCT02252679|"~     The purpose of this study is to determine whether mass spectrometry analysis of stable~     (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of~     bone and calcium disorders.~   "
61464|NCT02252666|"~     The investigators hypothesis is that electrical stimulation to the tongue that directly~     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural~     impulses to the brainstem and cerebellum. The investigators call this cranial nerve~     non-invasive neuromodulation (CN-NINM). The activation of these structures induces~     neuroplasticity when combined with specific physical exercises, can reduce symptoms of~     advanced MS, targeting primarily postural stability (sitting and standing), upper extremity~     movement, and ability to perform self-transfers.~   "
61465|NCT02252653|"~     The purpose of this study is to characterize the frequency of TTR mutations in subjects~     suspected of having cardiac amyloidosis~   "
61466|NCT02252640|"~     The purpose of this study is to assess two types of new malaria vaccines in different~     combinations. The study will enable us to assess:~        1. The ability of the vaccines to prevent malaria infection.~        2. The safety of the vaccines in healthy participants.~        3. The response of the human immune system to the vaccines.~      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then~     exposing them to malaria infection by allowing mosquitoes infected with malaria to bite~     under carefully regulated conditions. We will follow participants closely to observe if and~     when they develop malaria. If the vaccine combination provides some protection against~     malaria, participants will take longer to develop malaria than usual or will not develop~     malaria at all. We will also recruit 4 individuals to be control subjects - these~     participants won't receive any vaccinations but will be challenged with malaria.~      Vaccinated volunteers who do not develop malaria infection in the blood after being infected~     with malaria by mosquito bite the first time may be invited back to be again infected with~     malaria in a repeat challenge experiment. This would happen approximately 5-7 months after~     the first challenge. The purpose of this second challenge will be to see how long the~     protection of the investigational vaccine against malaria lasts.~   "
61467|NCT02252627|"~     During operations to treat abdominal problems the blood pressure can fall, resulting in~     falls in blood flow to the vital organs. This fall can be treated by the administration of~     drugs that cause constriction of blood vessels. Although these drugs correct falls in blood~     pressure, it is unclear what effect they have on blood flow from the heart and to the vital~     organs.~      In this study of healthy volunteers we aim to better understand the changes in blood flow in~     both small and large vessels that occur in response to administration of these drugs. To do~     this we will use two different techniques of ultrasound imaging. A narrow (4-5mm) ultrasound~     probe will be inserted into the oesophagus via a nostril to measure blood flow in a major~     blood vessel. A second probe will rest on the abdomen and will record changes in blood flow~     in small vessels of the liver. Two drugs which raise the blood pressure via different~     mechanisms will be administered and the changes in flow from the heart and to vital organs~     will be measured and compared.~   "
61468|NCT02252614|"~     Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of~     paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour~     after a lumbar disk surgery.~   "
61469|NCT02252601|"~     The purpose of this study is to find out whether the High Frequency Digit Triplet test can~     be used to screen patients with cystic fibrosis for hearing loss in conditions of health and~     pulmonary exacerbation. It is also designed to find out the youngest age at which a child~     can perform the test, the prevalence of hearing loss in a CF population and the prevalence~     of genetic mutations known to be associated with hearing loss in the same population.~   "
61470|NCT02252588|"~     Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota~     biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic~     bronchitis. Our primary outcome will be to compare the microbiota biomass (number of~     bacteria as measured by 16S rRNA copy number) of induced sputum and the oral cavity before~     and after 8 weeks of twice-daily chlorhexidine oral rinse (n=25) compared to controls (n=25)~     using qPCR and next-generation sequencing of the bacterial 16S rRNA gene comparing total~     bacterial biomass~   "
61471|NCT02252575|"~     E-Transportation is increasing all over the world. It is not known if the used engines~     interfere with cardiac implantable electronic devices. The study evaluates such potential~     interferences in vivo.~   "
61472|NCT02252562|"~     Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public~     health concerns that impact all areas of healthcare. Further work is needed to better~     understand these healthcare issues so that effective preventive measures can be developed.~      The investigators have developed and validated an experimental model for studying the risk~     factors for bacterial cross contamination in the surgical operating room. The investigators~     have confirmed in our previous work that intraoperative bacterial transmission events occur~     frequently both within and between surgical cases and that these transmission events are~     linked to 30-day postoperative HCAIs and increased patient mortality.~      In response, the investigators have implemented various strategies designed to bacterial~     transmission in the operating room, including anesthesia provider hand hygiene compliance.~     The investigators' recent work in the intensive care unit suggests that the hand hygiene~     system the investigators have previously studied could be further optimized.~      The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene~     system enhanced with novel wireless technology designed to facilitate real-time group and~     individual performance feedback.~      The investigators hypothesize that the use of this system will increase hourly hand~     decontamination events of anesthesia and circulating nurse providers and reduce 30-day~     postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay~     duration, and hospital re-admission rates, and mortality(secondary outcomes).~   "
61473|NCT02252549|"~     This study is a multicenter randomized controlled trial in which the efficacy between SPIES~     assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will~     undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive~     treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as~     short and long-term follow up.~   "
61474|NCT02252536|"~     The purpose of this study is to determine whether gabapentin enacarbil is effective in the~     treatment of problems with alcohol.~   "
61475|NCT02252523|"~     This will be an open, prospective pilot study with pharmacological analysis. This study is~     designed to assess the efficacity and safety of dexmedetomidine-based sedation in two~     subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48~     hours. Those with or at risk for intracranial hypertension requiring deep sedation and those~     requiring a light to moderate sedation for early neurological evaluation.~      The main objective is to assess the feasability of dexmedetomidine infusion in terms of~     efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted~     to intensive care unit and requiring sedation and mechanical ventilation for a predictable~     duration greater than or equal to 48 hours. Secondary objectives include the study of~     hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal~     fluid) drug concentration, opioates and co-hypnotic consumption.~   "
61476|NCT02252510|"~     It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This~     measurement helps to better diagnose male infertility and seems easy to apply in routine.~     However, the reliability of this method needs to be evaluated before applying for clinical~     practice in andrology laboratory.~   "
61477|NCT02252497|"~     The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid~     (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over~     height hours on blood loss.~   "
61478|NCT02252484|"~     The purpose of this study is to evaluate the effectiveness of a weight management program~     for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts~     weight gain, and reduces risk of cancer recurrence in the participants.~   "
61479|NCT02252471|"~     This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with~     master's level mental health professionals within a juvenile justice setting; 2) determine~     acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment~     satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk~     of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).~   "
61480|NCT02252458|"~     The purpose of this study is to examine whether two clinically sensible dose regimen of~     fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal~     rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application.~     Pain modalities tested will include transdermal electrical stimulation and cold pressor~     pain.~      The investigators hypothesize that the high dose fentanyl group will have an increase of~     approximately 20% in the NRS.~   "
61481|NCT02252445|"~     The investigators want to evaluate the efficacy of the propofol and sevoflurane for the~     prevention of catheter-related bladder discomfort.~   "
61482|NCT02252432|"~     The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar,~     an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after~     lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of~     both drugs may be able to provide better control of pain after lumbar surgery.~   "
61483|NCT02252419|"~     The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the~     prevention of postoperative sore throat.~   "
61484|NCT02252406|"~     The purpose of this study is to determine the effects of ranolazine on different markers of~     cardiometabolic disease in women with stable angina and on angina frequency.~   "
61485|NCT02252393|"~     This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion~     during robotic assisted radical cystectomy in reducing complications in patients with~     bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby~     tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to~     make a new way for urine to leave the body) is performed. It is not yet known whether~     intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion~     is a better method in patients with bladder cancer undergoing robotic assisted radical~     cystectomy.~   "
61486|NCT02252380|"~     The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a~     tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in~     patients with treatment-refractory symptoms of movement disorders.~   "
61859|NCT02247531|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study evaluating the efficacy and safety of lampalizumab administered by intravitreal~     injections in patients with geographic atrophy (GA) secondary to age-related macular~     degeneration (AMD).~   "
61487|NCT02252367|"~     At present time several preclinical and clinical study have demonstrated the safety and~     efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract~     symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction.~     However, the link between clinical outcomes (symptoms scores), functional activity~     (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern~     (molecular analyses), has not been previously investigated.~      Aim of present study is to assess, for the first time in literature, changes in pressure~     flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and~     tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with~     placebo and to correlate these data with changes in symptoms scores (IPSS, International~     Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.~   "
61488|NCT02252354|"~     The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and~     removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral~     tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).~   "
61489|NCT02252341|"~     Effects of N-Acetyl-Cysteine in patients with bipolar depression (primary outcome is~     Hamilton Depression Rating Scale) with and without tobacco use disorder and on inflammatory~     and oxidative stress biomarkers~   "
61490|NCT02252328|"~     The trial will compare the effect on disease control and immunosuppression treatment of~     adding simvastatin 80mg once daily, over a follow-up and treatment period of 2 years.~     Patients will be randomised in a 1:1 fashion to standard treatment with placebo or standard~     treatment with the addition of simvastatin (80mg daily). They will be followed at 3 months~     intervals for 2 years with a primary end point of mean reduction in corticosteroid dosage at~     the 12 month follow-up visit.~   "
61491|NCT02252315|"~     Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or~     alteration in mental status induced by an external mechanical force to the head. Education~     about symptoms and reassurance of a prompt recovery usually results in full recovery.~     However, a subgroup appears to have persistent symptoms and disability. This study will~     recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable~     patient characteristics that can delay or prevent full recovery. A secondary aim is to~     determine if providing education in writing or in-person makes a difference.~   "
61492|NCT02252302|"~     When exposed to air pollution, the asthma symptoms are aggravated and lung function is~     impaired. Due to high breathing rates and volumes, physically active individuals are at~     particular risk of lung health impairment due to the high breathing rates and volumes.~     Greater doses of air pollutants reach deeper areas in the lungs where they can trigger~     asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen~     even more, allowing the air pollutants to reach even deeper areas of the lung. With this~     study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and~     lung health in physically active asthmatics.~   "
61493|NCT02252289|"~     It is increasingly recognised that asthma is not a single disease but that there are many~     different phenotypes. Much of the work that we have previously carried out has focussed on~     differentiating children with difficult asthma (those whose asthma control improves with~     attention to the basics of asthma management such as adherence) from those with severe~     therapy resistant asthma (ongoing poor control despite high dose treatment and attention to~     the basics. Our collaborators in Basel, Switzerland have demonstrated that serial~     measurements of lung function (peak flow) in adults can characterise the severe asthma~     phenotype and its stability in adults with asthma. We plan to carry out twice daily peak~     flow measurement sin children with asthma using an electronic peak flow meter. We will~     analyse peak flow patterns in children with severe therapy resistant asthma (STRA),~     difficult asthma (DA) and mild to moderate asthma. We will also investigate the relationship~     between peak flow variations and symptoms, recorded in a daily diary and medication use,~     recorded by an electronic measuring device which attaches to the child's own inhaler~     (Smart-inhaler).~   "
61494|NCT02252276|"~     Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the~     same exercises and manual therapy on the recurrent ankle sprain management.~      Design: A randomized clinical trial with two intervention groups and triple blind.~      Settings: University Hospital.~      Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular~     sports practice and pain during the physical activity, randomly assigned to experimental or~     control group.~      Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises;~     experimental group performed 4 weeks of the same exercises combined with manual therapy.~      Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle~     eversion strength, and active range of motion in ankle joint. The measures were taken~     before, after and one month after the interventions.~   "
61495|NCT02252263|"~     To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and~     identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with~     either Lirilumab or Urelumab in subjects with multiple myeloma.~   "
61496|NCT02252250|"~     To investigates the feasibility, practicability, safety and subjective as well as functional~     outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.~   "
61497|NCT02252237|"~     The purpose of this study is to determine individual susceptibility factors (drug~     interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual~     variability towards corticosteroids (prednisone, prednisolone, methylprednisolone) in~     children, which could establish a base for therapeutic monitoring.~   "
61498|NCT02252224|"~     This surveillance is a postmarketing commitment following the marketing authorization for~     Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified~     by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical~     Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety~     assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.~   "
61499|NCT02252211|"~     The purpose of this study is to find a more effective way of treating solid tumors. This~     study will test the safety, bio-distribution, and tumor uptake of a new treatment for cancer~     called DS-8895a in patients with advanced solid tumors.~   "
61860|NCT02247518|"~     The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic~     properties of tadalafil~   "
61502|NCT02252172|"~     The purpose of this study is to compare the efficacy of daratumumab in combination with~     lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of~     progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a~     blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment~     of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).~   "
61503|NCT02252159|"~     This is a Phase IV, multicenter, non-interventional, non-randomized, prospective,~     observational study in an adult population (patients >18 years old) of men and women who~     have been diagnosed with clinically overt PV and are being followed in either community or~     academic medical centers in the United States who will be enrolled over a 12-month period~     and observed for 36 months from the date the last patient is enrolled.~   "
61504|NCT02252146|"~     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in~     approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B~     Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway~     of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the~     ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit~     ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P~     mutation ligand activation of those TLRs results in markedly increased signaling with~     subsequent increased cell activation, cell survival, and cell proliferation. The scientific~     rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P~     mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation~     of cells with the mutation and decreases the survival and proliferation of the cell~     populations responsible for the propagation of the disease.~   "
61505|NCT02252133|"~     The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact~     lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ±~     2 days of wearing of each product.~   "
61506|NCT02252120|"~     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic~     position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in~     non-paralyzed anaesthetized pediatric patients~   "
61507|NCT02252107|"~     This study examines whether the addition of decitabine to the standard Flu/TBI conditioning~     regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML~     patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any~     side effects, it will likely have little impact on the occurrence of Graft Versus Host~     Disease. The investigators are looking for a pre-treatment for transplantation which reduces~     the chance of recurrence of the disease without involving severe damage to normal tissues.~   "
61508|NCT02252094|"~     This study evaluates the use of ultra-protective ventilation, where very low ventilation~     volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting~     criteria to nurse in the prone position. Half the patients will receive ultra-protective~     ventilation support by extracorporeal carbon dioxide removal, while the other half will~     receive conventional lung protective ventilation.~   "
61509|NCT02252081|"~     Chronic kidney disease (CKD) is a major global health problem associated with substantial~     costs and resource utilization. Currently, CKD affects more than 500 million people~     worldwide. Patients with CKD have unacceptably high mortality rates due to cardiovascular~     (CV) causes, which are not entirely explained by traditional CV risk factors. The mortality~     rates in advanced CKD are six times higher compared to the Medicare population, with CVD~     accounting for the overwhelming majority of deaths. Insulin resistance (IR) is common in CKD~     patients and may represent a central link between CKD and the increased CVD risk observed in~     this population. Insulin resistance may increase CV risk by impairing and worsening~     endothelial function, increasing reactive oxygen species, and exacerbating systemic~     inflammation-hence, insulin resistance is considered a non-traditional CV risk factor in~     CKD.~      Obesity (defined by a body mass index [BMI] of at least 30 kg/m2) is a major public health~     problem-the upward trend in obesity prevalence across regions and continents is a worldwide~     concern. Obesity increases the risk for cardiovascular disease and death. In the general~     population, obesity hastens death by 9.4 years. Obesity is an independent risk factor for~     CKD. Besides its contribution to the development of diabetes and hypertension, increased fat~     mass may also have a direct impact on kidney function.~      In spite of the increasing prevalence of both obesity and CKD, the impact of obesity in the~     CKD population is not known, especially in terms of the exaggerated metabolic disturbances~     associated with their coexistence. It is highly likely that these two conditions have~     profound interactions that exaggerate the severity of the metabolic derangements when they~     coexist, particularly in regards to adipokine dysregulation, the risk of insulin~     resistance, and downstream effects on vascular health. The current proposal will attempt to~     characterize the relative and combined impact of both obesity and CKD on metabolic~     disturbances, which may aid in risk stratification and identifying specific targets for~     intervention.~      The ultimate goal of this proposal is to understand the relative and combined impact of~     obesity and CKD on the generation and maintenance of insulin resistance and their impact on~     cardiovascular health.~      Specific Aim 2: To study the effects of metformin, an AMPK activator, on metabolic~     disturbances associated with obesity and moderate CKD.~      S.A.2.a: To test if metformin will improve LAR in obese patients with moderate CKD compared~     to placebo.~      S.A.2.b: To test if metformin will improve markers of systemic inflammation, oxidative~     stress, endothelial dysfunction in obese patients with moderate CKD compared to placebo.~      S.A.2.c: To test if metformin will improve atherosclerosis markers and reduce clinical CVD~     events in obese patients with moderate CKD compared to placebo.~      Hypothesis: The investigators hypothesize that the administration of metformin in obese CKD~     patients will significantly improve the adipokine profiles-particularly through a reduction~     in LAR. Additionally, that it will improve systemic inflammation, oxidative stress and~     endothelial function, which may or may not be mediated by changes in adipokines. Finally,~     the investigators hypothesize that improvements in these markers of vascular health will~     translate into reduced arterial stiffness and less clinical CV events~   "
61510|NCT02252068|"~     Anxiety is highly prevalent among individuals with opioid dependence and confers greater~     risk for continued opioid use and poor treatment outcomes. However, there are currently no~     efficacious treatments available for co-occurring opioid dependence and anxiety. The~     ultimate aims of this trial are the development and testing of a novel integrated cognitive~     behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This~     clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We~     hypothesize that I-CBT will be a feasible and acceptable treatment that will result in~     significant reductions in anxiety and opioid use.~   "
61511|NCT02252055|"~     To collect evidence of the safety of administering autologous tolerogenic dendritic cells~     (ATDC) preparations to living-donor renal transplant recipients in the context of an~     international European Union funded consortium aimed at evaluationg cellular immunotherapy~     in solid organ transplantation (The ONE Study). It is anticipated that immune regulation~     induced by ATDC therapy can evntually be used to reduce the need for conventional~     immunosuppression in transplant recipients.~   "
61512|NCT02252042|"~     This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment~     (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and~     neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either~     pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis~     is that pembrolizumab treatment prolongs overall survival when compared to standard~     treatment.~   "
61513|NCT02252029|"~     This study will establish the duration of excretion of rotavirus vaccine in stool following~     vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.~   "
61514|NCT02252016|"~     This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC)~     of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic~     Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The~     primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir~     achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy~     (SVR12) will be greater than the reference rate of 40%.~   "
61528|NCT02251834|"~     Stroke is a leading cause of death and functional impairments and stroke risk factors (SRFs)~     disproportionately affect Latino populations. In the Hispanic Secondary Stroke Prevention~     Initiative (HISSPI) the investigators propose a study using Community Health Workers (CHW)~     and mobile technologies using cell phones to reduce the risk for a recurrent stroke among~     Latino stroke patients.~      The project examines the effectiveness of a combined multilevel intervention consisting of~     Community Health Workers (CHW) and mobile based phone technologies in lowering of systolic~     blood pressure (SBP) which is the most important risk factor for recurrent stroke.~   "
61555|NCT02251483|"~     The primary objective of this study is to determine whether giving SBI as a medical food~     starting with maintenance of health in the management of chronic loose and frequent stools~     in IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more~     prolonged duration of benefit and delay symptom recurrence. SBI is the main ingredient in~     EnteraGam™, an orally administered prescription medical food for the dietary management of~     patients with enteropathy or chronic loose or frequent stools, including patients with~     IBS-D.~   "
61515|NCT02252003|"~     In clinical practice with young children, gold standard rating scales used to evaluate the~     pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are~     self-assessment tools. These scales present however certain limitations: the VAS is not~     applicable if the child does not know how to estimate the distances, as young children, or~     children with mental retardation. As for FPS-R, it can be frightening for children by the~     aspect of faces looking like impersonal masks.~      For children under 4 years, only hetero-evaluation based on typical behavioral scales as~     Face Legs Activity Cry Consolability (FLACC) can be used, according to the current~     recommendations.~      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural~     and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide~     sample of children. We made the hypothesis that the teddy scale would enable to evaluate the~     pain in the same way that the FPS-R, being better accepted and preferred by children.~      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy~     children from 4 to 11 year-old, having already experienced pain. This stage allows the~     validation of the images chosen for the scale, to make sure of their relevance and their~     optimal recognition by the children.~      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11~     years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11~     years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be~     asked to determine which scale they preferred. Children from 2 to 4 years old will have the~     teddy scale; the FLACC will be filled in by parents.~      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that~     of the FPS-R scale The validation of the teddy scale will enable to objectify children's~     pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to~     check the efficiency of these decisions. This teddy scale could be used in current practice~     as a replacement of the FPS-R.~      Following this study, we planned to set up a second project in which the teddy scale will be~     adapted to electronic form (touchpads), to test its adaptability with the children.~   "
61516|NCT02251990|"~     This is a randomized, parallel-group, placebo-controlled, multi-site, multinational,~     double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172)~     in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination~     [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype~     (GT) 1, 4 or 6 infection. The primary hypothesis is that the proportion of participants~     receiving grazoprevir/elbasvir FDC in the immediate treatment arm achieving SVR12 (Sustained~     Virologic Response 12 weeks after the end of all study therapy) will be superior to the~     reference rate of 73%.~   "
61517|NCT02251977|"~     The primary objective of this study is to assess the efficacy of~     monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in~     colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.~   "
61518|NCT02251964|"~     This project will address rare immune mediated inflammatory diseases (IMIDs) involving the~     lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the~     effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary~     study parameter is pulmonary function.~      The secondary objectives are to explore the application of imaging with radiolabeled RTX as~     early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of~     life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical~     markers.~   "
61519|NCT02251951|"~     The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II~     trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and~     gastro-esophageal junction~   "
61520|NCT02251938|"~     The objective of this extension study is to evaluate the long-term safety of treatment with~     DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye~     who have participated in the SAKURA development program.~   "
61521|NCT02251925|"~     This study is a prospective randomized controlled trial to compare the pregnancy outcomes of~     frozen embryo transfer in natural and hormonal replacement cycles. The study population~     consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and~     frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran~     Iran.~   "
61522|NCT02251912|"~     Purpose: Test whether oxytocin treatment decreases symptoms of withdrawal from alcohol and~     decreases drinking in people who have been consuming alcohol heavily for long periods and~     are physically and psychologically dependent on (addicted to) alcohol.~      Participants: 50 adults with alcohol dependence~      Procedures (methods): Oxytocin or placebo will be administered three times a day for the~     first 2 days of the 12 week period, followed by twice daily intranasal sprays for the rest~     of the 12 weeks. Before, during and at the end of the trial, each subject will undergo~     evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about~     amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol~     craving and, at some visits, laboratory measures (blood and urine) to monitor safety and~     alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4~     weeks and 12 weeks to evaluate for post-medication safety and efficacy~   "
61523|NCT02251899|"~     The aim of this study is to determine whether a nurse-managed telephone-based~     disease-management intervention can reduce healthcare utilization and improve self-assessed~     health status in patients with congestive heart failure.~   "
61524|NCT02251886|"~     Moxibustion was tested for version of a breech position in singleton pregnancies. The women~     were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20~     minutes or no moxibustion. In week 36-37 the fetal position was checked and external~     cephalic version was offered for those still in breech position. The randomization was~     stratified for primigravida and multiparae separately. The randomization was made with a~     random number even and odd numbers indicating moxibustion or not. The randomization result~     was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn~     when the woman gave informed consent to the study.~   "
61525|NCT02251873|"~     Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)~     administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the~     effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the~     short-term safety of this combination~   "
61526|NCT02251860|"~     ARATA is a prospective, non-interventional, multi-center, observational study in Germany to~     evaluate the long-term effectiveness and tolerability of subcutaneously administered~     RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis in daily clinical~     practice. Participants will be followed over an observation period of up to 2 years after~     the initial injection.~   "
61527|NCT02251847|"~     To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe~     versus monotherapy of rosuvastatin in hypercholesterolemia patients~   "
61600|NCT02250898|"~     The aims of this study are to determine the effectiveness of myofascial massage specific to~     the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among~     patients who have undergone a mastectomy or other breast surgery compared to a control group~     receiving global relaxation massages.~   "
61529|NCT02251821|"~     This phase II trial studies how well giving a JAK inhibitor before a donor stem cell~     transplant works in treating patients with myelofibrosis that developed without another~     condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors~     are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed~     for cell growth. Giving a JAK inhibitor before a donor stem cell transplant may help reduce~     symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the~     patient's general physical condition, and prevent complications from occurring after the~     transplant. Infusing healthy stem cells from a donor into the patient may help the patient's~     bone marrow work normally and make stem cells, red blood cells, white blood cells, and~     platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve~     transplant outcomes in patients with myelofibrosis.~   "
61530|NCT02251808|"~     This study will be done because the investigators would like to evaluate product~     satisfaction of two PINS products (product A, product B) that are to evaluate the~     effectiveness of rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit~     and at follow-up visit) and by evaluating their responses to the product satisfaction survey~     that will be given to them by a study coordinator.~   "
61531|NCT02251795|"~     Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir~     (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at~     steady state plasma concentrations on other platelet functions and biomarkers of coagulation~     and fibrinolysis.~   "
61532|NCT02251782|"~     Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden~     and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually~     screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test)~     testing, both have patient-associated barriers that reduce their use. The combination of~     bowel preparation and procedure time are barriers to colonoscopy, while stool handling as~     part of the sampling protocol reduces FIT usage.~      It has been hypothesized and supported by a variety of preference studies that the~     availability of a blood-based assay for CRC screening would increase patient participation~     and adherence to CRC screening by reducing barriers that prevent participation.~      This study is designed to investigate the relative participation in CRC screening in average~     risk, screening eligible patients with demonstrated non-adherence to guideline-recommended~     screening modalities. Participation with the fecal immunochemical test (FIT) and the~     blood-based Epi proColon® test will be examined. Screening eligible average-risk patients~     identified as non-adherent by medical record will be eligible for the study. Potential~     subjects will be recruited to participate in a study via mailing and/or at a clinic visit.~     All study subjects will be enrolled at a clinic visit and will be randomized in two study~     arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to~     Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be~     compared between those that accept and complete the blood test and those that accept and~     complete the FIT test. A passive control, usual care arm will comprise subjects meeting~     eligibility criteria, but not recruited for or participating in the study.~      In conjunction with published data (Johnson et al, 2014), the relative utilization of the~     blood test will be compared to the screening participation via FIT. Increased participation~     with the Epi proColon blood test could increase screening rates in the non-adherent~     population. Additionally, for those testing positive in the trial, the rate of adherence to~     colonoscopy will be determined.~   "
61533|NCT02251769|"~     To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500~     mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the~     effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.~   "
61534|NCT02251756|"~     Study objective To assess the performance of different application regimens of Actinica® on~     protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned~     healthy subjects (phototype I to III).~      Study centers A total of 20 subjects will be enrolled in 1 site in France.~      Methodology This will be a monocentre, randomised, controlled, investigator-blind,~     intra-individual comparative clinical investigation.~      There will be a total of 6 visits for each subject. Each subject will participate for a~     period of maximum 35 days.~      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype~     I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion~     criteria.~      The clinical investigation will be conducted in 2 parts.~      Part 1 - SPF determination:~      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2~     mg/cm2).~      Part 2 - Sun exposure:~      To assess the performance of the different application regimens of Actinica® on protection~     from UVR-induced erythema throughout 1 day of sun exposure.~   "
61535|NCT02251743|"~     Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder~     (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has~     several randomized controlled trials showing significant benefit, but which are inconclusive~     because they were not double-blinded; the benefit could have been nonspecific (placebo~     response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a~     month's medication), It is important to know how much specific benefit it yields. This 2-~     site placebo-controlled double-blind randomized clinical trial is the first to test for a~     specific benefit of neurofeedback with adequate power, the first designed and implemented~     collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to~     rigorously monitor quality not only of treatment, but also of placebo and blinding, and the~     first to follow up for 2 years to examine enduring effect; the results, whether positive or~     negative, will provide evidence for clinical practice and public policy regarding ADHD.~   "
61536|NCT02251730|"~     To propose a feasibility study of introducing a smoking cessation program in head and neck~     cancer patients with planned radiotherapy. The study will feature the feasibility, safety,~     and efficacy of a prospective smoking cessation program during head and neck irradiation.~   "
61537|NCT02251717|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults~     with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a~     kidney transplant.~   "
61538|NCT02251704|"~     This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003~     studies, enrolling from the same HDSS (health and demographic surveillance system)~     populations. The primary objectives are to produce longitudinal estimates of parasite~     prevalence in humans, and record malaria control measure usage in areas where EPI-MAL-002~     and EPI-MAL-003 studies will take place.~   "
61539|NCT02251691|"~     The main objective of this study was to compare the drug compliance in patients after renal~     transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.~      The rationale for this study is to access the influence of once-daily prolonged-release~     tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal~     transplantation recipients base on the assumption that once-daily dosing regimen may help to~     improve drug compliance.~   "
61601|NCT02250885|"~     Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and~     gastrointestinal and pancreatic neuroendocrine tumors.~   "
61540|NCT02251678|"~     Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein~     (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),~     Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.~      Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with~     triggering factors such as trauma, inflammation or medication.~      Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.~     Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,~     Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,~     Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability~     to inhibit tumor necrosis factor-α (TNF-α).~   "
61541|NCT02251665|"~     A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage,~     and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in~     the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying~     characteristics, stroke features and severity, process for diagnosis and acute treatment,~     and long-term outcomes of stroke/TIA patients over the years.~   "
61542|NCT02251652|"~     Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of~     hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore,~     use of ingenol mebutate will also be evaluated for potential treatment of subclinical~     lesions.~   "
61543|NCT02251639|"~     The goal of this clinical study is to find out if certain instruments/devices, such as wide~     field fluorescence imaging point spectroscopy and/or brush cytology, can help health care~     providers find mouth cancer more quickly than a standard oral clinical exam.~   "
61544|NCT02251626|"~     To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after~     burn injury and that ubiquinol supplementation will increase plasma and intracellular~     coenzyme Q10 levels in burn patients.~      To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial~     dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins~     (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.~   "
61545|NCT02251613|"~     The purpose of this study is to evaluate the effectiveness and safety of Olopatadine~     Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution,~     0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a~     history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly~     assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl~     ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge~     (CAC) with Japanese cedar pollen will be performed.~   "
61546|NCT02251600|"~     Study to characterize the single-state and steady-state dosing of oral deflazacort in~     pediatric and adolescents subjects.~   "
61547|NCT02251587|"~     The purpose of this study is to learn if a weight loss program especially designed to~     address food insecurity is more effective compared to a standard weight loss program.~   "
61548|NCT02251574|"~     The purpose of this study is to test the effectiveness of two different weight loss diets on~     obstructive sleep apnea (OSA) severity.~   "
61549|NCT02251561|"~     The purpose of this study is to compare an investigational contact lens care product (FID~     109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal~     staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked~     in the products for 24-48 hours prior to a 2-hour contralateral wear period.~   "
61550|NCT02251548|"~     This research study is evaluating a new drug called ibrutinib in combination with the~     standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment~     for Chronic Lymphocytic Leukemia (CLL).~   "
61551|NCT02251535|"~     Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in~     the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs.~     rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based~     motion capture evaluation. How do different levels of intra-operatively observed femoral~     rollback correlate to postoperative kinematics under weight bearing conditions? Does the~     modified design of the Attune Knee System influence the extent of the femoral rollback~     compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of~     12 months follow up or is it reduced by, for example, remodelling of the posterior cruciate~     ligament?~   "
61552|NCT02251522|"~     It has been noted that patients dramatically overestimate their functional ability early~     after surgery. Despite use of assistive devices increasing and functional testing scores~     decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome~     questionnaires will be administered and functional testing will be conducted on all patients~     to capture these changes.~   "
61553|NCT02251509|"~     This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart~     rate control in patients with atrial fibrillation and a rapid ventricular rate.~   "
61554|NCT02251496|"~     At least one fifth of patients in European hospitals are malnourished. Malnutrition is~     associated with negative consequences, including higher rates of complications, longer~     hospital stay, impaired wound healing and increased mortality with consequent effects on~     costs of healthcare. Evidence suggests that there may be benefits to some malnourished~     patients from receiving oral nutrition supplements in the short-term but it is not known~     whether these benefits can be sustained and indeed whether similar benefits may be achieved~     using food-based interventions of lower cost. The overall objective of the study is to~     compare two nutritional interventions among malnourished patients with COPD (n=200); oral~     nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during~     hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is~     weight change. Secondary endpoints include forced expiratory volume in one second, forced~     vital capacity, six-minute walk distance, hand-grip strength, health related quality of~     life, length of hospital stay, energy- and protein intake, readmissions to the hospital and~     acute exacerbation. No studies are available comparing the supply of ONS to malnourished~     patients with COPD compared with the provision of regular food (in-between meals snacks).~     The results of the study will provide important information that might improve nutrition~     care in the hospital setting as well as after discharge from the hospital~   "
61861|NCT02247505|"~     The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic~     properies of tamsulosin~   "
61556|NCT02251470|"~     BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in~     rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo~     Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger~     trials are necessary to verify these positive effects after discharge from the hospital.~      AIM: This study aims to prepare and optimize a phase III trial which compares the effects of~     two HBE programs for stroke patients.~      METHODS: A pilot study with randomized control design and repeated measures over~     three-months will be conducted. Twenty elderly stroke patients will be randomly allocated to~     an experimental group (EG) and a control group (CG). All participants will receive an~     introduction to a HBE program by an individual mentoring over 6 weeks. During the following~     6 weeks the participants perform the HBE on their own. The EG will perform a balance~     exercise program using the WII, the CG will perform a balance exercise program without~     technical support.~      Recruiting potential, the participants' acceptance of the intervention and economic aspects~     will be examined. Additionally, basic information about sensitivity of change and potential~     effect sizes regarding the proposed instruments to measure mobility are expected.~   "
61557|NCT02251457|"~     The purpose of this study is to gather preliminary data to determine if ranolazine is a safe~     and effective treatment for the symptoms of myotonia congenita and paramyotonia congenita.~     The duration of the study is 5 weeks.~   "
61558|NCT02251444|"~     This study investigates effects of a multidisciplinary rehabilitation program or physical~     therapy in patients with chronic low back pain on emotion regulation and coping behaviour.~      Hypothesis: Significant differences of negative emotions pre and post treatment and between~     groups after intervention.~      Standardised questionnaires are used for investigation~   "
61559|NCT02251431|"~     Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with~     impaired relaxation of the heart mildly reduced kidney filtration function (Type 4~     cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of~     treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker~     blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain~     identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.~   "
61560|NCT02251418|"~     Introduction:~      Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain,~     discomfort and reduced quality of life. The development of foot ulcers places the patients~     at a risk of amputation. In the Danish Health Care System a substantial effort is done to~     prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is~     ongoing. The goal is to optimize wound healing and prevent amputations.~      Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates~     low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A~     small amount of energy will be deposited in the tissue when shockwaves are applied. This~     stimulates the cells to produce substances that generate new vessels. No side effects to~     ESWT have been shown.~      Purpose:~      The investigators want to test whether shockwave therapy can improve wound healing among~     diabetic patients with foot ulcers.~      Hypothesis:~      The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases~     blood flow, reduces pain, and has no side effects.~      Method:~      Patients who are interested in participation will be included in the study and divided by~     randomization into two groups of equal size. The first group is treated with ESWT in~     combination with regular guideline treatment. The second group is set up as control group~     and will only receive regular guideline treatment. The participants are examined in~     different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators~     want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are~     inspected for infection at every consultation, and a swab sample will be collected at~     enrollment. The size of the ulcers are measured and photographed each time. The~     investigators will count how many foot ulcers that are completely healed during the test~     period and measure the sizes of the remaining foot ulcers. The patients are asked to~     evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and~     use of analgesic drugs are obtained from the patient journal and by patient interview.~      Significance:~      ESWT should be considered a supplement to existing clinical guidelines in wound management~     if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce~     the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency~     of amputations among diabetic patients will decline by implementing new treatment options~     for the diabetic foot.~   "
61561|NCT02251405|"~     One source of melamine exposure in the modern life is from the use of melamine tableware.~     This study examines whether the use of stainless steel containers can decrease melamine~     exposure in the daily life. The investigators hypothesize that, compared to those without~     use of stainless steel containers, university student volunteers with use of stainless steel~     containers excrete significantly lower melamine levels in urine.~   "
61562|NCT02251392|"~     This study aims to evaluate therapeutics interventions in radiodermatitis in patients with~     breast or head and neck cancer. The data collect is going to begin after determining the~     better dose in a dose-response curve that is being conduct now in the same institution. To~     evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group~     (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse~     Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).~   "
61563|NCT02251379|"~     This study evaluates the effects of adding on an environmental home intervention to standard~     asthma medication management on controller medication requirements among children and~     adolescents with asthma. The investigators hypothesize that the addition of an~     individually-tailored, multi-faceted Environmental Control Strategy (ECS) to~     guidelines-based controller medication will result in less controller medication requirement~     and allergic inflammation than controller medication alone among urban asthmatic children.~   "
61564|NCT02251366|"~     Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has~     revolutionized the management of neovascular age-related macular degeneration (NVAMD).~     However, the requirement for near monthly administration of therapy coupled with the growing~     number of patients needing treatment has become a universal challenge in efficient delivery~     of care for retina physicians. While many retina practices have both increased the size of~     their staffs to accommodate the growing patient population and increased efficiency with the~     aid of digital photography, patient encounter times in clinic continue to increase, often~     spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined~     alternative in the evaluation of patients with NVAMD to determine whether intravitreal~     therapy with an anti-VEGF agent is indicated at a particular office visit would be~     desirable.~      This multi-satellite, prospective, randomized pilot study will compare standard-of-care,~     physician- based retinal evaluation, defined as retinal examination by a physician and~     standard imaging with optical coherence tomography (OCT) and optional fluorescein~     angiography (FA), versus physician-guided diagnostic evaluation, defined as standard imaging~     with OCT and optional FA without retinal examination by a physician in the management of~     NVAMD with anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating~     that the physician-guided diagnostic approach to managing patients with NVAMD is not~     inferior to the physician-based retinal evaluation based on measures such as a change from~     baseline in visual acuity and in central subfield thickness (CSF) on OCT. Other outcomes to~     be assessed in this study are length of visit times, numbers of intravitreal injections of~     anti-VEGF agents administered, numbers of diagnostic tests performed to determine whether~     treatment should be given at each visit, and frequency of retinal examinations performed for~     each participating patient in each cohort. Perceptions of quality of vision and patient~     satisfaction will be captured by interviews with patients following each clinic visit;~     clinical impressions of physicians will be captured by a brief physician survey. Finally,~     the feasibility of recruiting patients, as measured by how many eligible patients are seen~     at each Wilmer satellite, how many patients agree to be randomized, how many patients~     follow-up, and the attrition rates at the 4 and 8-month outcome visits will be assessed.~   "
61565|NCT02251353|"~     The number of intervention performed for metastatic breast cancer has dramatically increased~     over the past 2 decades. Hepatectomy and pulmonary resection for stage IV colorectal cancer~     is now considered the standard of care for resectable patients with isolated hepatic and/or~     pulmonary disease and acceptable performance status. However, the indications for resection~     / intervention of breast cancer origin metastases are not as clearly defined. The aim of~     this study to focus on emerging data for the intervention (resection and/or radiofrequency~     ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic~     radiosurgery) of breast cancer metastatic disease to the lung and liver, with a focus on~     indications for resection / intervention.~   "
61566|NCT02251340|"~     The objectives of this project are to increase families' understanding of eczema and improve~     eczema management in the primary care setting. We have created an Eczema Care Plan similar~     to those used in the management of asthma. It gives specific instructions about medications,~     bathing and moisturizing, as well as when to seek further treatment. We will conduct a~     randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period.~     Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and~     (3) increase parental knowledge and confidence about eczema management. We also plan to~     track provider uptake and documentation of the plan and elicit feedback from parents and~     providers on the utility and feasibility of the plan.~   "
61567|NCT02251327|"~     Consenting adults will be interviewed for demographic and medical information, and then will~     be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will~     be tested using conventional and investigational diagnostic tests for tuberculosis.~   "
61568|NCT02251314|"~     Despite recent advances in cancer treatment, little impact has been made on curing as~     opposed to controlling cancers over the last several decades. Part of the problem is that~     investigators have an incomplete understanding of how tumours behave as they evolve and in~     response to treatment. In this trial, the investigators hope to better understand the~     evolution of BRAF melanoma in response to drugs a patient may have received such as~     vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours~     evolve resistance to these drugs and whether this can be predicted through blood tests, in~     particular of the circulating tumour DNA.~   "
61569|NCT02251301|"~     The purpose of this study is to investigate whether combining interval training with skim~     milk supplementation will result in improved glucose control and markers of cardiovascular~     health in people with type 2 diabetes. Participants will complete supervised interval~     training three times a week over a 12 week training period while consuming skim-milk,~     whey/casein protein drink, or a placebo beverage that does not contain any calories or~     vitamins/minerals immediately and 1 hour after each training session. After twelve weeks~     participants will repeat baseline tests to examine any effects of the intervention on their~     glucose control, fitness, blood vessel function, body composition, and blood markers of~     inflammation.~   "
61570|NCT02251288|"~     A phase I prospective, randomized study in healthy adult subjects at a single center. Adult~     subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate~     as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks~     (Group 1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group~     (Group 4) which will not be scheduled for a booster dose but will serve as a backup for~     dropouts in the other three groups. A fifth group will receive two intramuscular doses of~     adjuvanted H7N9 pIIV separated by four weeks.~   "
61571|NCT02251275|"~     The purpose of the study is to evaluate and describe the long term safety of tolvaptan in~     patients with autosomal dominant polycystic kidney disease (ADPKD~   "
61572|NCT02251262|"~     With aging of the general population and broadening indications, the number of pacemaker~     recipients is steadily increasing. The incidence of infections of the implanted material, a~     dreaded major complication, is also rising. The diagnosis is evident in presence of an~     abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to~     the lead. On the other hand, a proportion of patients present with less specific clinical~     manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious~     disorder of unknown origin despite detailed investigations. Without proof of lead infection,~     removal of the system without confirmation of its infection is usually proposed, despite the~     known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive~     culture of the leads implies that the leads were involved in the infectious process. In~     recent years, 18FDG-PET-CT scan has made promising contributions in different areas~     including imaging to detect infection at different organ sites. Absence of hyperfixation of~     the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing~     system infection.~      The extraction of intracardiac implanted material, when it is indicated by the current~     standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients,~     even when they did not receive antibiotics before extraction.~      The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current~     strategy may avoid or reduce these false-positives.~      Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to~     avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive~     value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at~     providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its~     sensitivity.~      For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with~     suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit;~     secondarily, an intervention for the extraction of the intra-cardiac material, under general~     anesthesia, will be practiced and then a bacteriological culture for extracted material will~     be required.~      The end of study visit is complete the last day of material extraction. The follow up will~     last 2 to 7 days.~   "
61573|NCT02251249|"~     Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial~     infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric~     emptying time is observed during STEMI, limiting the use of morphine and encourage the use~     of prokinetic agents can be a first answer to optimize coronary angioplasty environment.~      Investigators propose a study to assess the gastric emptying times at the acute phase of~     myocardial infarction using a validated paracetamol absorption test. The STEMI group will be~     compared to in one hand, itself with measures performed 72 hours±12h after the event onset;~     and on the other hand, to a stable patient group referred for angioplasty for angina or~     non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient~     group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by~     VerifyNow® test and correlated to gastric emptying times.~   "
61607|NCT02250807|"~     The purpose of this study is to show superiority of simeprevir (SMV) in combination with~     sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite~     of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in~     combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in~     study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior~     relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in~     this study.~   "
61574|NCT02251236|"~     The project will have two tracks, one for participants who are currently taking~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir~     alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for~     participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track~     B).~      Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF)~     STR** (if available) for 24 weeks.~      *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,~     and 300 mg of tenofovir disoproxil fumarate.~      **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,~     and 10 mg of tenofovir alafenamide fumarate.~   "
61575|NCT02251223|"~     Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) /~     ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs.~     TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine,~     stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three~     treatment groups will be enrolled sequentially starting with the highest tipranavir dosage~     group first and ending with the lowest tipranavir dosage group.~      Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine,~     abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared~     to historical controls.~      B) To assess the safety of three tipranavir/ritonavir combinations when used in combination~     with protocol defined antiretrovirals.~   "
61576|NCT02251210|"~     To investigate efficacy and safety of 3 doses of BIIL 284 BS in active rheumatoid arthritis~     (RA) and determine the dose with most positive efficacy / safety ratio. Pharmacokinetic~     profile will be also obtained.~   "
61577|NCT02251197|"~     The objective of this study is to assess the safety, tolerability and pharmacokinetic~     characteristics of BIII 890 after intravenous infusion in acute ischemic stroke patients.~   "
61578|NCT02251184|"~     Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole~     administered as the immediate release formulation plus aspirin, under conditions of reduced~     stomach acidity.~   "
61579|NCT02251171|"~     Study to determine the effects of steady-state Tipranavir (TPV) / Ritonavir (RTV)~     (500mg/200mg bid) on the single-dose pharmacokinetics of Rifabutin (RFB) and to determine~     the effects of single-dose RFB on the steady-state pharmacokinetics of TPV 500mg~     (co-administered with RTV 200mg)~   "
61580|NCT02251158|"~     Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir~     (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration~     and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with~     food versus without food.~   "
61581|NCT02251145|"~     Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500~     mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of~     tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the~     pharmacokinetics of tipranavir/ritonavir.~   "
61582|NCT02251132|"~     The objective of this study is to establish the tipranavir-ritonavir steady-state~     dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the~     effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to~     establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally,~     the short-term safety and tolerance of this drug combination will be evaluated.~   "
61583|NCT02251119|"~     The objective of the study was to determine if the co-administration of loperamide (LOP)~     with tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically~     significant change in the respiratory response to carbon dioxide (CO2), defined as a 10%~     decrease in the area under the pharmacodynamic effect/time curve or at least a 25% decrease~     in at least one pharmacodynamic time point.~   "
61584|NCT02251106|"~     A recent province-wide survey (Alberta, Canada) suggests that clinicians' beliefs about soft~     lumbar bracing for low back pain (LBP) vary substantially. Approximately 50% of clinicians~     (MDs, DCs, PTs) find back braces useful for acute back pain while the remaining half~     report that bracing causes muscle atrophy. While previous studies suggest bracing for acute~     low back conditions can reduce pain and does not cause atrophy, no prior study has assessed~     back function after bracing using self-reported and objective measures within the same~     cohort.~      PURPOSE:~      To assess both self-reported and objective measures of spine function before, and after, use~     of an inelastic lumbar brace over a two week period.~      STUDY DESIGN:~      Before-After Design~      OUTCOME MEASURES:~      Self-reported spine function, spinal stiffness and muscle endurance.~      METHODS:~      Three groups were studied: asymptomatics who did not wear a brace (-LBP/-Brace),~     asymptomatics who were braced (-LBP/+Brace) and acute LBP subjects who were braced~     (+LBP/+Brace). Both groups of braced subjects (-LBP/+Brace; +LBP/+Brace) were instructed to~     wear the brace continually for 2 weeks with the exception of bedroom & bathroom activities.~     Before and after the 2 week period, 3 measures of spine function were performed: spinal~     stiffness via motorized indentation of the L3 spinous process, a modified Sorensen test~     (timed lumbar extension against gravity), and the Oswestry Disability Index (ODI). Unbraced~     (-LBP/-Brace) subjects were studied over the same time with the same measures. Repeated~     measures analyses of variance were conducted for all three outcomes with a significance~     level of 0.05.~   "
61602|NCT02250872|"~     Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by~     acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4)~     inhibitors are well known to improve glucose intolerance by augmentation of endogenous~     glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4~     inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model~     of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group,~     placebo-controlled, prospective study to investigate the renoprotective effect of DPP4~     inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with~     cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups.~     Subjects will take study drugs for 8 days starting from one day before cisplatin treatment.~     Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7~     days after cisplatin treatment.~   "
61603|NCT02250859|"~     The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101~     4% foam product in male and female some of which are with acne~   "
61585|NCT02251093|"~     The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of~     Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus~     rhamnosus Lcr35® is a live bacterium administered with its culture medium.~      It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking:~     0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects~     (lowering the vaginal pH).~      A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus~     rhamnosus Lcr35®:~        -  to establish itself in the vaginal epithelium, along with the durability of this~          establishment.~        -  and to inhibit the growth of pathogenic organisms responsible for causing bacterial~          vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida~          albicans), by synthesising various microbicidal substances.~      This research follows on from the Candiflore observational study in which 514 patients were~     monitored and which demonstrated a clearly positive result in favour of the use of vaginal~     Lcr Regenerans® for preventing recurrences of VVC.~      The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in~     the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC~     with recurrent episodes, in view of obtaining a marketing authorisation.~   "
61586|NCT02251080|"~     Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There~     are many safe oral therapies that require daily use to be effective. Because frequent~     follow-up visits have been shown to increase adherence to medication, we will determine if~     adherence to oral therapy for ADHD will improve with an intervention involving weekly~     internet-based contact without an office visit.~      The primary aim is to determine the effectiveness of an Internet-based survey in improving~     adherence to therapy for ADHD. Subjects in this study will be either receive a weekly~     Internet-based survey assessing the prescribed medication and their ADHD, or to receive~     standard-of-care therapy in which they will take their medication. The following hypothesis~     is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD~     medications.~   "
61587|NCT02251067|"~     The purpose of this study is to determine whether VPI-2690B Injection is effective in the~     treatment of diabetic nephropathy.~   "
61588|NCT02251054|"~     This study compares the efficacy of embedding avatars into an online self-management program~     that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy,~     and adherence versus the same program without avatars~   "
61589|NCT02251041|"~     The purpose of this study is to establish the effectiveness of the combined drug approach~     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,~     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce~     ischemia-reperfusion injury during liver transplantation in eligible recipients.~   "
61590|NCT02251028|"~     The purpose of this study is to determine whether a specifically tailored value-based~     cognitive behavioural therapy program (V-CBT) is able to prevent the development of~     persistent disability, pain, and psychological distress if delivered within the first three~     months after a whiplash injury.~   "
61591|NCT02251015|"~     To investigate the effects of the use of occlusal splint over postural balance in~     individuals with signs and symptoms of temporomandibular disorder. The research group~     consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and~     75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD~     questionnaire and magnetic resonance imaging of the temporomandibular joints. The research~     is a randomized, controlled, prospective clinical study with intervention. Postural~     equilibrium will be evaluated by means of a force plate. In the randomization, the splinted~     group was under an occlusal-stability criterion as well as advised under therapeutic~     exercises while the control group got only orientation about therapeutic exercises. After 12~     weeks, the groups were re-evaluated. The results will be analyzed by categorical data using~     absolute and relative frequencies as well as continuous data using average, median, standard~     deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the~     times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of~     significance of 0.05.~   "
61592|NCT02251002|"~     The purpose of this study is to determine whether there is a quantitative relationship~     between brain processes seen by a MRI and visual deficits caused by mild to moderate~     traumatic brain injuries (mTBI).~   "
61593|NCT02250989|"~     The objective of this study is to investigative the influence of different levels of~     glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after~     myocardial infarction~   "
61594|NCT02250976|"~     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to~     evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized~     fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen~     cap.160mg(micronized fenofibrate160mg) and Livaro tab. 2mg(pitavastatin Ca 2mg) under fed~     condition in healthy male volunteers.~   "
61595|NCT02250963|"~     This study aimed to compare dobutamine stress echocardiography (DES) with computed~     tomography coronary angiography (CTCA) in patients with undergoing intermediate to high risk~     noncardiac surgery.~   "
61596|NCT02250950|"~     The current study involves conducting an intervention based on self-determination theory~     (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse~     sample. It is expected that this intervention will successfully increase physical activity~     in participants.~   "
61597|NCT02250937|"~     The goal of this clinical research study is to compare how well two different schedules of~     giving busulfan with fludarabine and cladribine before a stem cell transplant in patients~     with AML or MDS may help to control the disease. The safety of this drug combination will~     also be studied.~   "
61598|NCT02250924|"~     This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial~     of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure.~     Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three~     times daily for 30 minutes starting the day following surgery until discharge or 24 hours~     after attainment of the primary endpoint.~   "
61599|NCT02250911|"~     The purpose of this study is to gather information on how easy it is to implement the~     workshop, as well as whether individuals find this workshop helpful. In this study,~     participants will be assigned at random to one of the two study groups. Based on the~     information we obtain, we hope to develop an easily accessible support service for~     caregivers.~   "
61608|NCT02250794|"~     The purpose of this study is to test whether a combination of two pills commonly used to~     treat outpatient diabetes called metformin and sitagliptin (januvia) could provide~     successful control of blood sugar levels in patients with type 2 diabetes during~     hospitalization for the treatment of a general medical condition. Both metformin and~     sitagliptin are currently approved by the Food and Drug Administration for the treatment of~     type 2 diabetes, but little experience exists for their use in hospitalized patients. The~     current standard practice is to use insulin injections to control blood sugar in~     hospitalized patients with type 2 diabetes. This study will compare the use of metformin~     tablets twice per day along with sitagliptin tablets once per day with daily insulin~     injections in patients with type 2 diabetes during hospitalization, and will study how well~     the blood sugar levels are controlled.~   "
61609|NCT02250781|"~     This phase I trial studies the side effects and best dose of Oral ONC201 in treating~     patients with advanced solid tumors. Oral ONC201 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
61610|NCT02250768|"~     The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage~     Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with~     repeated implantation failure (RIF)~   "
61611|NCT02250755|"~     This study therefore aims to assess current treatment recommended by scientific societies [~     6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain~     metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol /~     kg [ 14 ] . Sequences infusion different from one center to the other made : some use the~     infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to~     use one or the other of these sequences.~      No examination is added for the purposes of protocol. Indications for MRI and the number and~     timing of MRI checks under this protocol are consistent with what is done in practice . The~     used type of gadolinium and the injected dose will be identical for both sequences infusion~     . The assessment shall not in any case the contrast but the interpretation of the sequence~     itself. Special procedures monitoring implemented embodiment correspond to the two sequences~     instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and~     MRI of the first control , in order to compare their effectiveness~   "
61612|NCT02250742|"~     The study will establish data on the function of trunk muscles in healthy and low back pain~     patient's pre and post dry needling treatment. This will help in understanding the~     underlying mechanism of this treatment and reveal the effect of dry needling on muscle~     performance.~      Study hypothesis is that an improvement of back muscle function following dry needling~     procedure will be found.~   "
61613|NCT02250729|"~     The main objective of this study is to compare pholcodine exposure in patients having~     presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine~     exposure in matched anaesthetised patients with injection of NMBA, who did not present with~     an anaphylactic reaction (controls).~      The secondary objectives of the study are:~        -  To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the~          case and control groups.~        -  To study the concordance between exposure to pholcodine in cases and controls, by means~          of a patient self-questionnaire on the one hand and, on the other hand, by a~          computerized drug history, supplemented where relevant by the drug master file.~        -  To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.~        -  To study the association between exposure to pholcodine and the presence/levels of~          pholcodine-specific IgE, reflecting sensitisation to pholcodine.~        -  To study NMBA and pholcodine cross-sensitisation by testing skin reactions to~          pholcodine in case patients allergic to (at least) one NMBA.~   "
61614|NCT02250716|"~     Based on the high incidence of cervical cancer and high grade dysplasia and increased~     progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the~     effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month~     cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for~     HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen~     Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have~     had a colposcopic biopsy for persistent LSIL as per standard of care.~   "
61615|NCT02250703|"~     BACKGROUND INFORMATION AND RATIONALE~      Pediatric patients scheduled for dental procedures under general anesthesia can have~     significant anxiety before the procedure. They are commonly pre medicated to minimize~     distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose~     is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.~     It also has many limitations such as paradoxical reaction, increased incidence of emergence~     delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been~     used an effective and safe alternative premedication to oral midazolam in children. At a~     dose of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent~     sedation in children aged 5-8yrs with no adverse hemodynamic effects. It has other~     advantages such as providing analgesia and facilitating smooth emergence from anesthesia.~      The goal of this study is to find out if intranasal dexmedetomidine is a superior~     alternative as premedication to oral midazolam in children weighing more than 20kg~     undergoing general anesthesia for dental rehabilitation.~   "
61616|NCT02250690|"~     The aims of the present study was to analyze the effect of consecutive sessions of~     Transcranial direct current stimulation associated to kinesiotherapy about gait performance~     of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by~     means of space and temporal parameters as speed (meter/second ), stride frequency~     (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which~     is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to~     determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).~   "
61644|NCT02250326|"~     This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of~     second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying~     therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects~     with advanced non-small cell lung cancer (NSCLC).~   "
61645|NCT02250313|"~     The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for~     Prostate Cancer test in previously biopsied patients improves urologists' patient management~     by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse~     events in men being considered for a repeat procedure.~   "
61617|NCT02250677|"~     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases (CVD). The use of statins has increased markedly and it is now one~     of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a~     daily basis, 40 % of these are taking the medication without having any other risk factors~     for CVD than elevated blood-cholesterol i.e. they are in primary prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk~     of developing diabetes when taking statins. This has led to an increased debate about the~     use of statins in primary prevention. Furthermore a large meta-analysis has shown that to~     prevent one event of CVD, it is necessary to treat 200 people for 3-5 years. These data~     suggest that more conservative use of statins to prevent CVD in otherwise healthy~     individuals at low risk for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which~     potentially can prevent a physically active lifestyle. The biomedical background of these~     side effects is not fully elucidated but it has been shown that there is a link to~     decreasing levels of an important enzyme, Q10, which plays a role in muscle energy~     metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prohibit) physical exercise training? Furthermore we would~     like to answer the following questions:~      a Does statin treatment impair (or even prohibit) physical exercise training?~      b Does statin treatment cause:~        -  Decreased muscle strength?~        -  Skeletal muscle inflammation?~        -  Decreased mitochondrial respiratory function?~      c Abnormal glucose homeostasis?~   "
61618|NCT02250664|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the~     general US adult population. Opioid-dependent smokers are also at elevated risk for~     smoking-related adverse health effects. Studies testing an innovative regulatory strategy of~     reducing the nicotine content of cigarettes to a non-addictive level have shown promising~     beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased~     cessation) in the general population of smokers. However, these studies have uniformly~     excluded vulnerable populations like opioid abusers who may respond differently considering~     their greater vulnerability to smoking and nicotine dependence. Thus, little is known~     scientifically about how this highly vulnerable subgroup of smokers might respond to a~     nicotine reduction policy. This project is designed to address that substantial knowledge~     gap.~   "
61619|NCT02250651|"~     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in~     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month~     treatment period with an 8-month extended follow-up.~   "
61620|NCT02250638|"~     To obtain sufficient specimens and correlating clinical data from a well-controlled~     prospective clinical trial collecting longitudinal specimens from subjects diagnosed with~     any stage of pancreatic cancer.~   "
61621|NCT02250625|"~     To obtain sufficient specimens and correlating clinical data from a well-controlled~     prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,~     and to establish a collection of specimens that will support future assay discovery and~     validation efforts.~   "
61622|NCT02250612|"~     The purpose of this double-masked, randomized, controlled study is to assess the safety and~     ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops~     compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated~     intraocular pressure.~   "
61623|NCT02250599|"~     The present study will be a randomized, control, multicenter phase II study of metastatic~     nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and~     carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population~     consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy~     or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be~     evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H&N35 are~     used to measure PRO outcome for this study.~   "
61624|NCT02250586|"~     BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem~     gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can~     have devastating effects on the economy, health and relationship, both for the problem~     gambler and their concerned significant other (CSO). No empirically supported program exists~     for the CSOs of problem gamblers. Consequently, the aim of this study is to develop and~     evaluate a program aimed at CSOs of treatment refusing problem gamblers. The program will be~     based on principles from cognitive behavioral therapy and motivational interviewing. In~     order to benefit as many CSOs as possible, the program will be delivered via the Internet~     with therapist support via email and telephone.~      METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A~     cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem~     gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules~     over 10 weeks in a secure online environment, and receive support via text messages and over~     telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at~     baseline 3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating~     the PG to seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety,~     relationship satisfaction and quality of life.~      HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a~     reduction in gambling related harm experienced by the CSO, 2) the CBT-CSO program will~     reduce the CSO's anxiety and depressive feelings, 3) the CBT-CSO program will decrease the~     amount of time and money the problem gambler spend on gambling, 4) the CBT-CSO program will~     increase the CSO's relationship satisfaction with the problem gambler.~   "
61625|NCT02250573|"~     The main objectives of this study were to investigate the safety and efficacy of~     Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and~     achieve haemostasis in subjects with haemophilia B undergoing surgery.~   "
61626|NCT02250560|"~     The main objective of the study is to investigate the safety and efficacy of Replenine®-VF~     administered by continuous infusion in appropriate dosage to prevent bleeding and achieve~     haemostasis in patients with haemophilia B undergoing major surgery.~   "
61627|NCT02250547|"~     Evaluate the percentage of patients optimized at least once every month by the SonR~     automatic optimization method, until M6 follow-up, in Heart failure (HF) patients~     prevalently in sinus rhythm~   "
61646|NCT02250300|"~     This is a phase I/II study of MLN9708 for the prophylaxis of chronic~     graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell~     transplantation (HSCT). During the phase I portion patients undergoing both sibling and~     unrelated donor transplantation will be enrolled on the same arm to determine the dose~     limiting toxicity (DLT) and maximum tolerated dose (MTD). During the phase II portion of the~     trial, patients will be enrolled into two separate and independent cohorts: a) Matched~     sibling transplants and b) Unrelated donors transplants. Both cohorts will be enrolled and~     analyzed separately.~   "
61628|NCT02250534|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine~     dependence, and using high nicotine yield cigarettes and are also at significantly increased~     risk for smoking-related adverse health consequences, including cervical cancer, thrombosis~     related to hormone-based contraception, infertility, and early menopause. Studies testing an~     innovative regulatory strategy of reducing the nicotine content of cigarettes to a~     non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced~     toxicant exposure, and increased cessation) in the general population of smokers. However,~     these studies have uniformly excluded vulnerable populations like disadvantaged worn who may~     respond differently considering their greater vulnerability to smoking and nicotine~     dependence. Thus, little is known scientifically about how this highly vulnerable subgroup~     of smokers might respond to a nicotine reduction policy. This project is designed to address~     that substantial knowledge gap.~   "
61629|NCT02250521|"~     Our primary aim for the study is to measure intubation success rate on first attempt in~     management of the difficult airway, which could possibly allow us to determine at what~     direct laryngoscopic grade it becomes advantageous to use the McGRATH® MAC video~     laryngoscope.~   "
61630|NCT02250508|"~     The main objectives of the study were~        -  to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of~          vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and~          Factor VIII assays.~        -  to compare the clinical tolerance and safety of these two treatments after single IV~          infusions in subjects with VWD.~   "
61631|NCT02250495|"~     The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara~     Therapeutic System in the treatment of hypertension~   "
61632|NCT02250482|"~     The main objective of the study is to investigate the safety and efficacy of Optivate®,~     administered in appropriate dosage to present bleeding and achieve haemostasis in patients~     with Haemophilia A undergoing surgery.~   "
61633|NCT02250469|"~     12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in~     patient experiences with two different types of Spinal Cord Stimulator devices which are~     routinely used to treat chronic pain.~   "
61634|NCT02250456|"~     Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X~     chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and~     ovarian failure with infertility.~      Other anomalies are inconstant: morphological characteristics of varying intensity,~     associated malformations, and increased risk of acquired diseases ...~      The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular~     complications (congenital heart disease, dilatation of the ascending aorta with risk of~     dissection or rupture of aneurysm), causing early mortality with reduction of life~     expectancy of at least 10 years.~      For these reasons, screening for heart disease and dilatation of the ascending aorta is~     established and is intended to prevent the complications associated with medical treatment~     and / or surgery to increase life expectancy and reduce the co-morbidities.~      On the vascular level, the recommendations other than those relating to the monitoring of~     the diameter of the ascending aorta include research of renal artery stenosis by doppler~     ultrasound if the patient is hypertensive and looking for lymphedema.~      However, other arterial lesions were described in the literature, outside of the aneurysm of~     the ascending aorta. These peripheral arterial lesions can also be life and / or functional~     prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner~     syndrome.~      In addition, specific vascular lesions outside the affected artery are described: hepatic~     cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or~     lymphatic disease is unknown.~      A single-center review of 9 cases of patients followed at the University Hospital of~     Strasbourg showed the presence of vascular lesions discovered incidentally during~     assessments performed for reasons other than cardiovascular screening: cystic lymphangioma,~     internal carotid aneurysm, agenesis of the inferior vena cava, early varicose veins,~     embryonic cerebral artery, etc ... None of these patients showed any dilatation of the~     ascending aorta or heart disease. Peripheral vascular abnormalities in this patient group~     are exclusive.~      In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the~     entire arterial territory and is not confined to the ascending aorta. Screening for arterial~     lesions should be performed on the entire arterial vascular tree and regularly in the course~     of time, especially as the presence of cardiovascular risk factors increases with the age of~     these patients.~      The venous and lymphatic vascular damage in the literature and in our series of cases in~     University Hospital of Strasbourg description should also lead to the detection of these~     lesions.~      These vascular complications can be alone responsible for the reduction in life expectancy~     or responsible for serious morbidity. Improved screening of associated vascular lesions is~     necessary to enable the best prevention of cardiovascular complications.~      It is also to establish the prevalence of vascular anomalies, whether arterial, venous or~     lymphatic, to better understand the disease and its management. By collecting systematically~     karyotype leading to diagnosis, it may be possible to make a link between the genetic defect~     and heart or vascular disease.~   "
61635|NCT02250443|"~     This study is an open-label, long-term study for those patients who participated in the~     prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients~     with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is~     designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term~     dosing.~   "
61636|NCT02250430|"~     In this study, color (erythema) and pH will be measured on 3 consecutive days after~     application of 2 doses of SB204 to the cheeks of healthy volunteers.~   "
61637|NCT02250417|"~     Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI~     is the number of times per hour of sleep that the airway temporarily collapses at the level~     of the tongue or soft palate. In a significant number of individuals with OSA, the severity~     of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine~     (back) position and lowers in the lateral (side) position. This is called positional OSA.~      The primary objective of this study is to determine whether sleeping with a novel sleep~     surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those~     with positional OSA.~   "
61638|NCT02250404|"~     This pilot research trial studies molecular signatures of the return of cancer after a~     period of improvement (relapse) in tissue samples from patients with small cell lung cancer~     who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue~     from patients with small cell lung cancer in the laboratory may help doctors learn more~     about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related~     to cancer relapse.~   "
61639|NCT02250391|"~     Patients with portal vein thrombosis, who have chronic liver diseases especially liver~     cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06~     or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified~     in a randomized, double-blind, parallel-assignment design based on the proportion of~     patients obtained complete recanalization or partial recanalization of portal vein~     thrombosis.~      The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and 21 days after administration in comparison with~     the placebo group.~   "
61640|NCT02250378|"~     This pilot clinical trial studies the side effects and how well stereotactic radiosurgery~     followed by wedge resection works in treating patients with early stage non-small cell lung~     cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic~     radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation~     therapy that delivers a single, high dose of radiation directly to the tumor and may kill~     more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive~     type of surgery for removal of the tumor and a small amount of normal tissue around it.~     Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option~     for patients who cannot receive standard treatment with lobectomy.~   "
61641|NCT02250365|"~     This study evaluates the effect of electrical somatosensory stimulation (ESS) on the~     restoration of upper limb functioning in acute stroke patients. The effect will be measured~     at the end of the intervention and six months post-stroke. We expect that ESS facilitates~     the restoration of upper limb functioning and the brain reorganization following stroke.~   "
61642|NCT02250352|"~     This research trial establishes a breast tumor tissue repository from core biopsies.~     Collecting breast tissue from core biopsies may allow doctors to learn more about the~     biology of breast cancer and to analyze proteins, genes, and other components of tumor~     cells. It may also allow doctors to conduct future studies to help understand how breast~     cancer grows and how it responds to different types of therapy. This will help doctors~     develop better breast cancer therapies and better tests to help make treatment decisions.~   "
61643|NCT02250339|"~     The purpose of this study is to examine the feasibility and the effects of family-based~     interventions for children (aged 5-12) with neuropsychiatric and psychiatric disorders in~     Finnish health care settings.~   "
86232|NCT01928667|"~     The purpose of the study is to assess among others environmental and hygiene-related risk~     factors for microscopic colitis (MC), a common diarrheal disease.~   "
61647|NCT02250287|"~     The purpose of this study is to establish normal Magnetic Resonance quantitative values~     (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level~     Determination values for both renal cortex and medullary tissues and total renal blood flow)~     for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,~     and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and~     normal renal function.~      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,~     Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization~     Transfer and renal blood flow) will have different values in young adult ADPKD patients as~     compared to normal volunteers.~   "
61648|NCT02250274|"~     The purpose of this study is to assess the serologic and cell-mediated immune response to~     licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in~     children 5-17 years old. The effects of prior infection and or prior season vaccination will~     be examined. Children will be followed during the influenza season to identify~     laboratory-confirmed influenza (i.e. vaccine failure).~   "
61649|NCT02250261|"~     Walking and cycling to work is a natural way of increasing lifestyle activity in working~     population. In Finland, active travel is acknowledged as one of the key components in the~     most previous policy documents and initiatives related to physical activity promotion.~     However, the evidence on the effectiveness and cost savings of environmental as well as~     social and behavioral strategies in promoting active travel is thin both nationally and~     internationally. This study focuses directly on this gap by 1) conducting a~     cluster-randomized, controlled intervention where environmental change is supported with~     social and behavioral strategies in a large workplace area in Tampere, Finland, 2) assessing~     the cost-effectiveness and health-economic impact of the intervention and 3) examining the~     environmental mediators and moderators of active commuting to work among working aged~     population.~      The study will be conducted in Hatanpää workplace area located just outside the city center~     and including hundreds of workplaces. Workplaces with the minimum of 10 employees are~     contacted for recruitment in August 2014. Baseline information is collected about the~     workplaces (web-based questionnaire), employees (questionnaire, accelerometer, travel log)~     and environment (traffic calculations and audit system, Geographic Information System=GIS)~     first in September-October 2014 and second in March-April 2015.~      In the first phase of the study a cycle superhighway across the workplace area is built by~     the City of Tampere. Its' effects on walking and cycling are assessed after immediate and~     mid-term (6 months) exposure with the same measures as at baseline in September-October 2015~     and second in March-April 2016. In the second phase, the workplaces are randomized to~     intervention and control group based on the most relevant factors related to their~     comparability. Each intervention workplace nominates an internal team, which develops a~     multilevel social ecological plan to promote active commuting to work. The research group~     supports the teams with material, examples and three meetings. The plan is executed in May~     2016 and the effects are assessed in September-October 2016 and March-April 2017. The~     work-places randomized to the control group in the second phase of the study participate~     only in data collection but are offered one supportive meeting for promoting active~     commuting to work after the study.~      Efficiency evaluation based on HEAT (Health economic Assessment Tool, www.euro.who.int/HEAT)~     and costs-to-effectiveness ratios are calculated in the end of the study for the combination~     of both phases as well as for the comparison of the phases. Environmental mediators and~     moderators related to active commuting to work are examined objectively at all evaluation~     points with GIS-analysis by connecting in-formation on physical environment to the routes,~     which employees are using for commuting to work. The information on estimated routes is~     obtained from the questionnaires (home and workplace addresses) and the information on~     actual routes from GPS, which a subgroup of employees will provide by using free-of-charge~     application (e.g. SportsTracker) in their smartphones.~   "
61650|NCT02250248|"~     The objective of this study is to evaluate the clinical success of AttraX Putty as a bone~     graft substitute for autograft in XLIF procedures.~   "
61651|NCT02250235|"~     Helping patient with long-term conditions to make informed decisions about adherence to~     their treatment is an important element in facilitating self-management. Estimates of~     non-adherence to treatment in people living with long-term conditions are typically high,~     averaging at around 50%.This not only impacts negatively on patient outcomes but also places~     a significant financial burden on healthcare provision.~      While clinical efforts have focused on promoting patient self-management, with some success,~     work in Psychology on behaviour change has had little influence on clinical practice. In~     this project, the team wish to evaluate the potential for a novel intervention from the~     behaviour change literature, self-affirmation, to promote improved fluid control among~     non-adherent patients. The intervention works by promoting a patient's sense-of-self~     (self-affirmation), which has been shown to modify the patient's acceptance of health-risk~     information, their self-efficacy, their intention to change, and subsequently their~     behaviour.~      A randomised controlled pilot trial is proposed. The trial is designed to build upon routine~     education about fluid control during dialysis visits, and will compare a group of patients~     who have received an intervention to boost their sense-of-self (self-affirmation arm) to a~     control group (control arm). Patients in the self-affirmation arm should have a more~     positive evaluation of the health-risk information about fluid management, feel more able~     to, and intend to change their fluid control behaviour, and subsequently have lower~     interdialytic weight gain.~   "
61652|NCT02250222|"~     Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable~     addition to diet and exercise to improve glycemic control in adults with type 2 diabetes~     mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose~     production characteristic of type 2 diabetes mellitus that is a major contributor to~     hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating~     doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with~     type 2 diabetes mellitus.~   "
61653|NCT02250209|"~     The objective of this study is to assess the clinical efficacy and safety of trastuzumab~     plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.~   "
61654|NCT02250196|"~     Colonoscopy is a common screening method to detect polyps and CRC. With the early detection~     of CRC through screening colonoscopy, patients could have better therapeutic effects and~     outcomes. In population screening programs, an increase in completed colonoscopies is~     related to a decrease in mortality from CRC. However, the miss rate for detecting colorectal~     neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel~     preparation results in the relatively low rate of detection of polyps and CRC, because poor~     preparation interferes with successful colon mucosa examination during a colonoscopy.~      Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4~     liter polyethylene glycol. However, studies comparing the superiority between low-volume~     bowel preparations are rare, and results are controversial. This study aimed to compare the~     bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium~     citrate and polyethylene glycol with ascorbic acid.~   "
61675|NCT02249923|"~     Patients are being asked to be in this research study because medical researchers hope that~     by gathering information about a large number of children with pulmonary hypertension over~     time, their understanding of the disease process will increase and lead to better treatment.~     Investigators believe that pulmonary hypertension in children is different than pulmonary~     hypertension in adults and this study will help us understand those differences.~   "
61655|NCT02250183|"~     This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum~     honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in~     the wound, patient satisfaction, and treatment costs in patients with partial thickness~     burns. The study has four hypotheses:~        1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in~          significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.~        2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield~          significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria~          when compared to SANTYL® sites.~        3. It is hypothesized that patients will provide significantly higher patient care~          satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey~          sites when compared to ratings with regard to their SANTYL® sites.~        4. It is hypothesized that treatment costs, across participants, will be significantly~          lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.~   "
61656|NCT02250170|"~     This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will~     characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid~     tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,~     pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.~   "
61657|NCT02250157|"~     This study a nonrandomized, open-label, uncontrolled, single group assignment, safety and~     activity study in subjects with histologically or cytologically confirmed solid tumor that~     is metastatic or unresectable and for which standard curative or palliative measures do not~     exist or are no longer effective.~   "
61658|NCT02250144|"~     Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is~     defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to~     patellofemoral malalignment and soft tissue overload.~      A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral~     pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the~     outcome of morpho-specific foot orthoses in a prospective randomized study.~      The purpose of this prospective randomized study is to compare clinical outcomes in daily~     living and in sports activities, between morpho-specific and placebo foot orthoses.~      Morpho-specific foot orthoses are designed according to the patient's morphotype. They are~     intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to~     correct abnormal overload during patellofemoral tracking.~   "
61659|NCT02250131|"~     Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide~     production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in~     cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the~     correspondent critical value of DO2/VCO2 ratio is around 5.0.~      Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased~     incidence of acute kidney injury (AKI) after cardiac operations.~      These observations offer an interpretation for the well-known deleterious effects of~     excessive hemodilution during CPB, supported by many studies where an association between~     nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is~     reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the~     kidney, that due to its peculiar circulation is particularly susceptible to a decrease in~     the oxygen supply.~      However, there is no evidence that a strategy directed towards the specific goal of avoiding~     critical values of DO2 during CPB may actually decrease the postoperative AKI rate.~      The present study is designed to verify the hypothesis that a strategy based on a~     goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is~     effective in limiting the postoperative AKI rate.~   "
61660|NCT02250118|"~     Metastatic pleural effusion is a common complication of late-stage cancer and reduces the~     quality of life and survival of patients. The survival of patients with recurrent pleurisy~     by uncontrolled local or systemic treatment is less than 6 months. It is important to~     develop specific therapies to improve the quality of life and survival of patients with~     metastatic pleurisy.~      Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven~     effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an~     angiogenic factor which increases endothelial permeability. It plays a central role in many~     tumors of epithelial origin. In this context, it is legitimate to ask whether an~     antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by~     decreasing local blood supply and over-permeability.~      No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies~     and there are no predictive or prognostic biomarkers for metastatic pleural effusions.~      The investigators believe that intrapleural administration of bevacizumab will reduce the~     pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and~     reduce the replenishment of effusion due to its prolonged half-life of 21 days.~      The investigators therefore propose a phase I study to determine the maximum tolerated dose~     and the recommended dose for phases II, studying the pharmacokinetics of intrapleural~     bevacizumab administered by an implantable device after evacuating a symptomatic metastatic~     pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be~     study and the time until a new puncture. Dyspnea will be evaluated as well as its impact on~     quality of life.~   "
61661|NCT02250105|"~     This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo~     in reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL)~     hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week~     washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins~     during this period], 4 weeks for patients on statins only or not receiving any type of~     lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3,~     at least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the~     qualified subjects will be randomized at visit 4 and enter the double-blind, 12-week~     efficacy and safety assessment phase. End-of-study lipid levels will be assessed on visits 6~     and 7 (weeks 11 and 12 average). A final closeout and safety assessment visit will be done~     14 weeks post randomization~   "
61676|NCT02249910|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of~     metformin and digoxin in healthy subjects.~   "
86243|NCT01928524|"~     The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of~     docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.~   "
61662|NCT02250092|"~     Hemiparetic cerebral palsy influences motor function in children during development and~     throughout their lifetime. The deficits one sees are the result both of the congenitally~     induced brain lesion and the subsequent plasticity that can impair function of the surviving~     neurons in the damaged brain.~      Many current treatments have limited influence on children's neurorecovery.~     Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to~     encourage use of the affected limb has shown promise, yet with new technology revealing the~     potential to directly influence the brain, there is an urgent need to study the synergy of~     combined techniques.~      Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the~     potential to act synergistically with CIMT to influence neurorecovery.~      Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel~     form of neuromodulation, transcranial direct current stimulation (tDCS), we will investigate~     the influence of this intervention on improved motor outcomes in children with cerebral~     palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT~     and tDCS wherein those children who receive the combined intervention will reveal no major~     adverse events, yet improved hand function and cortical excitability.~   "
61663|NCT02250079|"~     INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries~     in the basic technology for neonatal adaptation may not be available. Polyethylene bags may~     be an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the~     differences between babies undergoing body bag with polyethylene or conventional drying~     during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,~     Colombia, 2013.~      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried~     conventional (control) or polyethylene body bag (intervention). The procedure lasted 10~     minutes, the bag body and / or radiant heat lamp was removed. Environment temperature and~     humidity, temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured.~     Statistical Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio~     (RR) and confidence intervals (CIs) were determined using contingency tables for risk~     analysis of the outcome. The study was approved by the hospital ethics committee of victory.~   "
61664|NCT02250066|"~     investigators evaluated the efficacy of two types of diet with different macronutrients, on~     prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting~     glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were~     randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106)~     or control group (n=109) and followed for 2 years. For calculating daily energy requirement~     in subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the~     ideal body weight with no attempt for losing body weight. Control group were encouraged to~     follow the Food Guide Pyramid and reduce their fat intake to less than 30% of energy~     consumed and saturated fat to less than 10 percent of total energy. The primary outcome~     variable was incidence of type 2 diabetes mellitus, diagnosed by the latest American~     Diabetic Association criteria.~   "
61665|NCT02250053|"~     Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of~     patients develop recurrent disease. Physical activity has emerged as a potential lifestyle~     intervention to reduce cancer recurrence and improve survival among people with colon cancer~     (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on~     molecular and cellular pathways associated with physical activity and CC outcomes among~     patients with stage II and III CC.~   "
61666|NCT02250040|"~     The purpose of this study was to identify and evaluate the effect of a new protocol of~     physiotherapy to retrain walking ability after stroke in subjects older than fifty-five.~     This protocol was composed of specific, clearly defined and reproducible techniques, based~     on clinical and functional criteria.~   "
61667|NCT02250027|"~     The purpose of this study is to determine the optimal dose of HL301 in patients with acute~     bronchitis or acute exacerbations of chronic bronchitis.~      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation~     of symptoms of cough and sputum~   "
61668|NCT02250014|"~     This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in~     treating patients with prostate cancer. Biological therapies, such as sargramostim, use~     substances made from living organisms that may stimulate the immune system in different ways~     and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells~     by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate~     cancer.~   "
61669|NCT02250001|"~     The primary objective of this study is: To evaluate the real-world safety, specifically the~     incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in~     Japanese patients chronically infected with HCV GT-1.~   "
61670|NCT02249988|"~     The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose~     of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic~     vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining~     control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg~     negative chronic Hepatitis B.~   "
61671|NCT02249975|"~     The purpose of this study is to assess the efficacy and performance of the C2 Focal~     Cryoablation System in patients with BE.~   "
61672|NCT02249962|"~     To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical~     outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for~     Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.~   "
61673|NCT02249949|"~     This phase II trial studies how well efatutazone dihydrochloride works in treating patients~     with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in~     chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading.~   "
61674|NCT02249936|"~     The study is designed to evaluate safety, tolerability, pharmacodynamics and~     pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects~     taking Omeprazole.~   "
61926|NCT02246660|"~     The RESTORE trial will determine whether resveratrol supplementation can improve walking~     performance in older people with lower extremity peripheral arterial disease (PAD).~     Resveratrol, a polyphenol and natural supplement, specifically targets several impairments~     associated with walking difficulty and mobility loss in people with PAD.~   "
61677|NCT02249897|"~     There is evidence of the association between diabetic microangiopathy and elevated serum~     concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with~     ingestion of specific foods (baked meats and milk powder); reducing their dietary intake~     lowers AGEs concentrations, with beneficial metabolic effects; however threre is still no~     evidence of whether this has an impact on microvascular complications of DM. We recently~     applied for funding to compare in a RCT the effects of Cholestyramine versus placebo, on~     visual electrophysiology. This drug is similar to Sevelamer in structure, both act as~     chelators of bile salts, and reduce absorption of dietary AGE, lowering serum levels.~     However it is essential to carry out preliminary tests to assess aspects that may imply~     adjustments to the proposed protocol, such as: 1) tolerance to the drug 2) short term effect~     of the drug versus placebo on serum levels of AGEs 3) effects of the drug versus placebo in~     levels of fat soluble vitamins (D and K specifically) 4) intra and interindividual~     variability of electrophysiological measurements of vision (ERGMF and optic nerve conduction~     velocity) 5) drug versus placebo in electrophysiological measurements of vision~     (neuroconduction ERGMF and optic nerve). Objective: The present project is planned as a~     pilot study, which will clarify points 1 to 5. Methodology: patients (6 DM2, 25 -50 y) will~     be assessed through anthropometry, clinical laboratory tests (creatinine, chemistry profile,~     lipid profile, microalbuminuria glycosylated hemoglobin, vitamin B12, 25OH vitamin D and~     prothrombin), dietary recalls specifically designed to analyze the regular consumption of~     AGEs, serum CML and neuro-ophthalmological study (fundus, ERGMF and optic nerve conduction).~     Subsequently each patient will be assigned to treatment with placebo for 3 months and then~     Cholestyramine 6 g / day for 12 weeks and at the end of each period will be reassessed using~     the same methodology. If patients cannot tolerate the drug, they will be assigned to a~     reduced AGE diet.~      Expected results: Cholestyramine will have side effect similar to placebo (mainly~     digestive). The active drug and not placebo will reduce serum levels of AGEs and~     electrophysiological parameters of vision at 12 weeks. It is expected that a low AGEs diet~     in patients who do not tolerate the drug will also reduce serum CML although to a lesser~     degree and will also induce electrophysiologic changes.~   "
61678|NCT02249884|"~     Dose response curve to define the security and tolerable dose to be used for prevention and~     treatment of radiodermatitis in patients with breast or head and neck cancer.~   "
61679|NCT02249871|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral~     semaglutide in healthy subjects.~   "
61680|NCT02249858|"~     Osteopathic medicine is a distinct school of medicine. Osteopathic physicians evaluate the~     neuromusculoskeletal system and work to achieve normal body mechanics. They use palpation to~     identify somatic dysfunctions. After performing osteopathic manipulative treatment (OMT),~     such as high velocity low amplitude (HVLA), a dysfunction is reassessed by palpatory~     assessment. While there are studies which show the effectiveness of OMT, a challenge remains~     to objectively assess a somatic dysfunction.~      The purpose of this study is to investigate the content validity of the palpatory~     examination for the cervical spine using ultrasonography and the effects of a single~     cervical HVLA technique. Content validity is the extent to which a measure adequately and~     comprehensively measures what it claims to be measuring. The Investigators aim to~     objectively assess diagnosis and treatment of the cervical spine.~      HVLA technique employs a rapid, therapeutic force of brief duration that travels a short~     distance within the anatomic range of motion of a joint, and that engages the restrictive~     barrier in one or more planes of motion to elicit release of restriction. It is also known~     as a thrust technique. The goal of the treatment is the restoration of physiological motion~     to the dysfunctional joint.~      Proper diagnosis of a joint dysfunction is important for spinal manipulation. Little~     assessment has been made of the clinician's ability to reliably identify a joint with~     biomechanical dysfunctions. Few studies attempt to address the challenge of evidence-based~     clinical practice. These have found the benefit of consensus training.~      In a study conducted by Shaw et al., ultrasound machine was used to assess the content~     validity of palpatory examination and objectively assess the effect of HVLA in the lumbar~     spine. The investigators aim to adapt the protocol for the cervical spine, but with the~     addition of a control cohort. Subjects will be subjected to the cranial vault hold, which~     assesses the primary respiratory mechanism in and the degree of participation of each bone~     in the general motion of the cranium. In the experimental group, participants will be~     receiving cervical HVLA to the key somatic dysfunction.~      The Investigators hypothesize that an ultrasound is a reliable instrument to objectively~     evaluate somatic dysfunction of the cervical spine. Furthermore, the investigators~     hypothesize that after performing cervical HVLA, the left and right articular pillars of the~     key somatic dysfunction vertebrae should be symmetrical compared to baseline.~   "
61681|NCT02249845|"~     The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale,~     Gorelick scale) among small children.~   "
61682|NCT02249832|"~     The purpose of this study is to determine if intensive lower extremity robotic therapy can~     improve gait speed and functional ambulation status in individuals 6 months or greater~     post-stroke.~   "
61683|NCT02249819|"~     The purpose of this study is to determine if non-invasive brain stimulation (transcranial~     direct current stimulation) delivered prior to language therapy will improve word-finding in~     individuals with aphasia who are 6 months or greater post-stroke.~   "
61684|NCT02249806|"~     PH is a serious disease with a dismal prognosis and impaired quality of life when left~     untreated. Reliable patient centered and prognostically relevant outcome measures are highly~     warranted in the field of PH. With this prospective cohort study the investigators intend to~     gain important information on the course of the disease and knowledge on the value of~     different new and already established outcome parameters.~   "
61685|NCT02249793|"~     As citizens of the information age, humans leave digital traces of behavior in their~     communication and movement patterns through our cell phone. The Global Positioning System~     (GPS) technology tracks the way persons commute to school or work or when visiting family~     and friends. Circadian rhythmicity describes the concept that many of the bodily functions~     follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is~     best during daytime while humans rest and sleep during nighttime. The current study wishes~     to look for a relationship between patterns in participants' cell phone use (Android only at~     this point) and several of their bodily functions.~   "
61686|NCT02249780|"~     Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation~     surgery. Create an objective basis for the decision whether or not to transplant the~     parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and~     thus abstention of systematic supplementation with calcium and vitamin D in case of good~     perfusion.~   "
61687|NCT02249767|"~     This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male~     and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild~     severity) acne vulgaris were treated on the full face once daily for 84 days with the~     Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded~     by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12~     at each location.~   "
61697|NCT02249637|"~     Given that both circumcision and orchidopexy are commonly done in a single setting, the~     investigators adopted the technique of orchidopexy via circumcision incision, particularly~     for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a~     novel technique and discuss our preliminary outcome of such procedure compared to the~     traditional inguinal-scrotal double incision technique. Specifically, the investigators~     aimed to determine the differences in operative time, testicular size changes,~     peri-operative complications, pain score and parent's satisfaction of both novel technique~     and conventional orchidopexy.~   "
62178|NCT02243384|"~     The purpose of this research is to compare short-term and long-term efficacy of laparoscopic~     hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma,~     and provide the evidence for the choice of surgical method from the pathology and cytology.~   "
61688|NCT02249754|"~     Building on the success of community-based peer education and counselling in breastfeeding,~     it is possible to address young child feeding and health practices in the surveyed district.~     Opportunities that can optimise success and encourage behaviour change in the district~     include mothers willingness to modify some feeding options; support of family members;~     seasonal availability and accessibility of foods; established set-up of village peers and~     existence of health centres and health staff in some villages. This study has developed a~     feasible, context-specific nutrition education package for use in rural Tanzania. The~     package is composed of 4 components, namely 1) education and counselling of mothers, 2)~     training of community-based nutrition counsellors, 3) sensitisation meetings with health~     staff and family members, and 4) supervision of community-based nutrition counsellors. The~     intervention will use a parallel cluster-randomised controlled trial design where infants~     will be recruited when aged 6 months and followed up for 9 months. The intervention expects~     to provide information and, where appropriate, recommendations to strengthen the nutrition~     component in the health education programme of the Tanzania child health services.~      The study hypothesises that the nutrition education package will be more effective than the~     routine health education in improving feeding practices, dietary adequacy and growth of~     infants and young children. Specific objectives of the study include:~        -  To evaluate the effectiveness of a nutrition education package on feeding practices and~          dietary adequacy~        -  To determine the effectiveness of a nutrition education package in improving growth and~          health of infants and young children~        -  To document the process of implementation of the nutrition education package to promote~          optimal feeding and health practice~   "
61689|NCT02249741|"~     Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced~     bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and~     osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of~     HOD in Indian population and its treatment outcome. The investigators aimed to determine~     prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone~     mineral density in patients with liver cirrhosis.~      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram~     Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic~     kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral~     density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine~     and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All~     patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and~     Estradiol in female) and parathyroid hormone (PTH) along with routine investigations.~     Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally~     for six months was given in patients with osteoporosis and DEXA scan repeated.~   "
61690|NCT02249728|"~     The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down~     and removed from the body when given as an oral capsule, a radiolabelled oral suspension and~     a radiolabelled intravenous injection.~   "
61691|NCT02249715|"~     -  To characterize physiological biomarkers of positive response to rDTMS using EEG and~          functional MRI (fMRI) in patients with PD.~        -  To develop a set-up and algorithm for neurophysiological monitoring for PD patients~          using EEG and fMRI in patients treated by rDTMS.~        -  To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of~          providing closed-loop feedback where monitoring informs the stimulation~   "
61692|NCT02249702|"~     The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60%~     of women present with disease limited to the uterus, cure rates range from 20 to 60%.~     Patients with metastatic disease at diagnosis or who recur after initial treatment have a~     dismal prognosis and, except for a subset of selected patients with completely resectable~     disease, the median survival is less than one year. Treatment options for~     recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are~     doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and~     27-53%, respectively. Both these regimens have been increasingly used in the last years also~     in the adjuvant setting. For relapsed patients other drugs have been tested as single agent~     but negligible activity was observed.~      Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated~     for the treatment of patients with advanced soft tissue sarcoma, after failure of~     anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS,~     activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma.~     Although the response rate did not exceed 10%, T was demonstrated to provide disease~     control, with progression arrest rates exceeding 50% and progression-free survival rates~     exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine~     leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in~     advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel~     translational studies will be performed to identify factors predictive of the activity of T~     in this specific histotype.~   "
61693|NCT02249689|"~     Comparison of different contact lens materials.~   "
61694|NCT02249676|"~     Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central~     nervous system affecting vision and brain and spinal cord function which leads to~     accumulating disability with a 5 year-mortality of approximately 30%. Survivors are~     typically left with severe morbidity secondary to blindness, quadriparesis and respiratory~     failure. No agent has been found to be highly effective in halting disease activity.Based on~     recent outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including~     multiple sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators~     anticipate that mesenchymal stem cells transplantation may provide lasting disease stability~     for neuromyelitis optica patients.~   "
61695|NCT02249663|"~     To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride~     and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in~     the relief of the signs and symptoms of Seasonal Allergic Rhinitis.~   "
61696|NCT02249650|"~     TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and~     applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.~      5441947) and Taiwan (Patent No. I432191 and I282280). The R&D laboratory in TSB is ISO/IEC~     17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is~     2026.The trade name of TSB-9-W1 is IDS in English, the registration number is 01472800 at~     2011 by Intellectual Property Office (IPO), Taiwan.~      A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the~     safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal~     cancer (mCRC).~      there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.~      This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.~      Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous~     3-day rest. Patient should take the study drug once daily before meal with approximately 250~     ml or appropriate amount of water.~   "
61698|NCT02249624|"~     Twins who share a placenta but have two separate sacs of amniotic fluid~     (monochorionic-diamniotic) are at risk of developing twin-to-twin transfusion syndrome~     (TTTS). TTTS results from anastomoses in the placenta that lead to unequal sharing of blood,~     causing abnormal blood flow to the twins. The donor twin may have low fluid levels, poor~     growth, and anemia. The recipient twin can have high fluid levels, high red blood cell~     counts, heart failure, and hydrops. Having TTTS, especially if there is demise of one twin~     or if disease is severe enough to warrant laser photocoagulation of the anastomotic sites,~     puts the surviving fetuses at risk for brain injury due to hypoxia, ischemia, or reperfusion~     injuries. Magnetic Resonance Imaging (MRI) is superior to ultrasound at detecting subtle~     cerebral injuries. An MRI scoring scale has been developed for use in very low birth weight~     infants that has been shown to correlate with neurodevelopmental outcomes, but it has not~     been tested in this patient population.~      Our center's guidelines recommend fetal MRI prior to intervention, at 32 weeks gestational~     age, and on the infants at term corrected gestational age. Infants who were treated for TTTS~     in utero are seen in Nursery Follow-up Clinic at 4 months of age, 8 months of age, and for~     Bayley Scales evaluations at 15-18 months of age and at 2-3 years of age.~      The purpose of this study is to correlate brain MRI score with neurodevelopmental outcomes~     in survivors of TTTS that have either required fetal surgical intervention or had demise of~     their cotwin. The investigators predict that more severe white and gray matter injury as~     determined by the Woodward/Inder grading scale will be positively associated with worse~     neurodevelopmental outcomes.~   "
61699|NCT02249611|"~     The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing~     for research purpose explication and informed consent will be collected before the study is~     executed. In the first 3 months, subjects of group A will use the mobile physical activity~     promotion tool (MT), receive professional personal counseling, and individualized reminding~     message (intervention) once a week. In the last 3 months, they will receive standard care~     (control) which is in support of behavioral and educational recommendations in diet control,~     increased physical activity, less smoking and drinking, deal with pressure, and regular~     health examination (based on the booklet of metabolic syndrome prevention which is edited by~     Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group~     B will begin with an initial 3 months control period of standard care only, and the~     intervention program will be conducted for last 3 months.~   "
61700|NCT02249598|"~     In the future it is likely that we will replace the current schedule of injected vaccines~     with interventions that interrupt transmission of infections in more subtle ways. The agent~     that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of~     individuals. In most people, the bacterium is harmless and survives for months in the~     nasopharynx, however in a minority of people the bacteria can cause invasive disease.~      Simply reducing colonisation amongst target groups may protect them, and the rest of the~     population as well. In a previous study we investigated cross protective antibodies, and~     found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless~     `cousin` of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could~     lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form~     of a nasal medication. The proposed study large experimental challenge study funded by~     Meningitis UK that will aim to establish if N. lactamica does or does not inhibit~     colonisation by N. meningitidis. We will also determine whether N. lactamica displaces~     existing N. meningitidis carriage, and whether there are individuals who are innately~     resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages~     of 1830yrs from the two universities in Sheffield. It will involve placing droplets of~     N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water~     like solution into the nose of the other half of volunteers. We will carry out nose swabs at~     intervals over a six month period to establish if the pattern of N.meningitidis carriage is~     effected by N.lactamica colonisation. If the findings are positive we will perform future~     mechanistic investigations. A62.~   "
61701|NCT02249585|"~     The purpose of this study is to find out the effect of low abdominal pressure vs. standard~     abdominal pressure on the cardiac and respiratory function of the patients undergoing~     laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the~     effect of the degree of neuromuscular blockade on the surgical condition of the patients~     undergoing laparoscopic colon surgery in Trendelenberg position.~   "
61702|NCT02249572|"~     The purpose of this study is to compare the outcome of patients with vestibular schwannomas~     in two groups of randomised to either radiosurgery or expectation.~      The optimal treatment for a small vestibular schwannoma is a matter of controversy and there~     are no class 1 studies investigating this. Even the natural tumor growth rate remains~     controversial and is reported to be from near 100% of cases showing growth to 40-60% in~     various reports. The clinical results of various treatment strategies are documented, but~     comparative studies are very few. Immediate radiosurgery or wait-and scan with subsequent~     treatment upon growth are two strategies that have both been used in many different centers.~     There are only two studies comparing these treatment modalities .These studies indicate~     significant effect of GKRS in reducing tumor growth, with less differences in hearing and~     complaint outcomes. None of the studies are blinded or randomised, allowing for bias.~      The present study aims at comparing the two modalities above. To achieve this, we intend to~     randomise patients with newly diagnosed VS to either of Wait-and Scan or immediate~     radiosurgery.~      The primary study endpoint is the relative tumor size measured as the ratio between tumor~     volume at four years compared with volume at inclusion. Secondary endpoints include symptom~     and sign development measured by clinical examination and by patient's responses to~     standardised validated questionnaires. In addition, the health economics involved with both~     strategies will be evaluated and compared, as well as the patient's working status.~      Patients will be asked to participate if their VS is diagnosed within the last six months,~     their age is between 18 and 70, and pending there are no exclusion criteria (see below). A~     power analysis indicates that about 50 patients per group is sufficient.~      In case of failure to recruit patients, we will change the design to a study based on~     patient's own choice of treatment.~      The study will be announced according to international guidelines. A steering committee will~     monitor the study and an intermediate analysis will be performed when the study group has~     been followed for two years. If the effect aim is already observed, the study should~     nonetheless continue, as it is too early to evaluate the results after such a short time~     course.~      It will also be discussed to do a follow-up of all patients ten years after inclusion.~   "
61703|NCT02249559|"~     This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife~     subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain~     stimulation.~   "
61717|NCT02249377|"~     This is a Prospective study with Randomized patients into either Ultrasound-guided~     Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3~     months and 6 months follow ups after aspiration at our institution. There will be 25~     patients in each group, including any patient with symptomatic baker's cyst.~   "
61704|NCT02249546|"~     Helicobacter pylori infection has been shown to be associated with the development of~     gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce~     the occurence or recurrence of these diseases. The triple treatment including a proton pump~     inhibitor, clarithromycin, and amoxicillin or metronidazole to treat H pylori infection,~     proposed at the first Maastricht conference has become universal since all the consensus~     conferences and guidelines around the world recommended it. However, the eradication rate of~     clarithromycin-based triple therapy has been declining in recent years, probably related to~     the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients~     would fail from first line standard eradication therapy and need second line rescue therapy.~      The H. pylori persistence in human infections and its resistance to the drugs commonly used~     in antimicrobial therapy have been attributed not only to genetic variability, but also to~     ability of H. pylori to form biofilm as a strategy to overcome environmental stress and to~     protect itself. Several recent reports indicate that H. pylori forms biofilm either in vitro~     or in vivo, N-acetylcysteine (NAC) were thought to reduce and prevent biofilm formation. Two~     small-scale clinical trials showed NAC offers additive effect on eradication effects of H.~     pylori therapy. A recent trial showed N-acetylcysteine pre-treatment before a culture-guided~     antibiotic regimen is effective in treating refractory H. pylori infection.~      Aims: Therefore, we aim to assess~        1. Whether triple therapy containing N-acetyl cysteine is more effective than standard~          triple therapy~        2. the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on~          the eradication rate of triple therapy containing N-acetyl cysteine.~   "
61705|NCT02249533|"~     Sports-related traumatic brain injuries (TBIs), including mTBIs—commonly referred to as~     concussions—are a serious public health concern. Diagnostic criteria and consensus return to~     play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and~     management of sports-related concussion as these guidelines are almost completely~     unsupported by an evidence base. It is well known that by increasing awareness of concussion~     signs and symptoms as well as the importance of addressing this injury, improving coaching~     on proper sports activity techniques and good sportsmanship, providing appropriate~     protective equipment, and quickly responding to injuries, the incidence, severity, and~     long-term negative health effects of sports-related concussion among children and~     adolescents can be reduced. The overall objective of this application, which is the first~     step toward attainment of our long-term goal, is to evaluate the effectiveness of Spot Light~     (a concussion injury management application [app] that coordinates diagnosis, management,~     and RTP procedures from injury to safe return to sport) when utilized by youth football~     teams. Our central hypothesis is that youth football teams randomized to receive SpotLight~     will report increased rates of concussion, increased referrals to physicians for care, and~     increased athlete compliance with RTP guidelines. The rationale that underlies the proposed~     research is that providing an easy to-use app has a high probability of effectively helping~     people involved with youth sports better recognize, respond to, and ensure athletes are~     fully recovered from sports-related concussion. We will test our hypothesis by pursuing the~     following aims: 1: Evaluate whether Spot Light will increase reported rates of~     sports-related concussion; Aim 2: Evaluate whether Spot Light increases referrals to~     physicians following concussion; Aim 3: Evaluate whether Spot Light improves the management~     of sports-related concussion. We expect to determine whether there is increased reporting,~     referrals to physicians, and athlete compliance with RTP guidelines. This contribution will~     be significant because it will allow physicians, athletic trainers (ATs), coaches, and~     parents to collaboratively track concussions from injury through safe RTP thereby lessening~     the chances of long-term negative outcomes as well as acute catastrophic outcomes.~   "
61706|NCT02249520|"~     This is an extended pilot protocol to facilitate on-site calibration of the technical~     aspects of the new Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic~     Resonance (PET-MR) scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging~     Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a~     FDA-approved standard clinical device (non-experimental) and will be used in accordance with~     clearance and approval from the FDA.~   "
61707|NCT02249507|"~     Aerobic exercise has the potential to diminish blood pressure values. The aim of this study~     is to determine whether this potential is also applicable for those with resistant~     hypertension and whether exercise intensity plays a role in this context. We hypothesize~     that performing an aerobic exercise session reduces blood pressure values in resistant~     hypertensive patients in a dose-response relation with exercise intensity.~   "
61708|NCT02249494|"~     The purpose of this study is to investigate whether the use of a mobile app could improve~     knowledge and practice in nutrition counseling performed by primary care physicians in~     Brazil.~   "
61709|NCT02249481|"~     Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24~     and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score~     which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic~     team).~      Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior~     patient mobilisation within the first 48 hours following total knee replacement compared to~     femoral nerve catheter infusions.~      Secondary Objective: To identify whether adductor canal nerve infusions result in superior~     analgesia within the first 48 hours following total knee replacement compared to femoral~     nerve catheter infusions.~   "
61710|NCT02249468|"~     Difference in nutritional status between patients with mild and moderate Alzheimer's Disease~     (AD) and cognitively intact healthy people in an Asian population~   "
61711|NCT02249455|"~     To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique~     in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients~   "
61712|NCT02249442|"~     To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir~     (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency~   "
61713|NCT02249429|"~     The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the~     Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309~     administered orally, as once daily capsules continously in patients with relapsed or~     refractory lymphomas.~   "
61714|NCT02249416|"~     The objective of this study was to characterize the effect of two dose combinations of~     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice~     daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as~     well as the effects of zidovudine on the pharmacokinetics of TPV/RTV~   "
61715|NCT02249403|"~     The objective of this trial was to assess the dose-response relationship of symptomatic~     efficacy of talsaclidine base on ADAScog and to assess safety and tolerability~   "
61716|NCT02249390|"~     The purpose of the study is to collate local information to better understand the~     motivations, accessibility and frequency of assisted reproductive technology (ART) use in~     the community.~   "
64247|NCT02216370|"~     Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence~     about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could~     be present but not revealed by rutinne ECG.~   "
61718|NCT02249364|"~     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what~     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.~      Two particular aspects of this study are~        -  the inclusion of women undergoing one day gynecological surgical procedures~        -  the use of a closed-loop system which delivers propofol according to bispectral index~          to provide induction of anesthesia.~   "
61719|NCT02249351|"~     Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients~     with mild to moderate dementia of Alzheimer type~   "
61720|NCT02249338|"~     Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils~     and specific inflammatory markers in patients with clinically well-defined moderate chronic~     obstructive pulmonary disease (COPD)~   "
61721|NCT02249325|"~     This pilot quasi experiment was designed to determine the feasibility of a randomized~     controlled trial of the oral probiotic combination of Florajen3 (>7.5 x109 L. acidophilus,~     >6.0 x109. B. lactis, and >1.5 x109 B. longum) taken orally once daily beginning at 28 weeks~     gestation, against placebo, to reduce the colonization of group B Streptococcus at 36 weeks.~   "
61722|NCT02249312|"~     Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in~     patients with asthma~   "
61723|NCT02249299|"~     Adult patients with ADHD commonly report an improvement in behavioural symptoms when using~     cannabis with some reporting a preference towards cannabis over their ADHD stimulant~     medication. The EMA-C study aims to investigate the effects of a cannabis based medication,~     Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.~      This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will~     take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance~     of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken~     before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will~     result in improvements in behaviour and cognition above that of the placebo group.~   "
61724|NCT02249286|"~     In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than~     the current nutrition and health education when investment on home-based food production is~     used as a platform for nutrition education. This project is proposed to evaluate the~     efficacy of a food-based package integrating child-centered nutrition counseling and~     home-based food production using a between-group comparative intervention study. The~     intervention comprises child-centered nutrition counseling for caretakers and support for~     'developed' gardens and improved backyard poultry production.~   "
61725|NCT02249273|"~     Background: Inappropriate use of antibiotics is one of the main causes for the increase of~     antibiotic resistance strains. In Denmark general practice accounts for 90% of all~     prescribed antibiotics and one of the most common reasons for prescribing antibiotics is the~     suspicion of a urinary tract infection (UTI). The use of point-of-care test is meant to~     decrease the uncertainty about the bacterial origin of the symptoms; however, there is a~     paucity of knowledge about the validity of the different diagnostic approaches, thus~     impacting on the proper use of antibiotics.~      Objective: To assess the diagnostic validity of different diagnostic approaches in patients~     with a suspected urinary tract infection and assess the impact on appropriate use of~     antibiotics.~      Methods: 70 practices at the capital region will consecutively include 15-20 patients. The~     inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) > 18~     years of age, c) patient consulting during office hours. Data at patient and GP level will~     be gathered.~      16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as~     a two-step process. The first step is the decision made during the consultation and the~     second step is the decision made after the consultation. Sensitivity, specificity and~     predictive values will be measure for each diagnostic approach using urine culture as a gold~     standard. The impact on proper use of antibiotics will be assessed in a hierarchical~     multivariable logistic model.~   "
61726|NCT02249260|"~     Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of~     this study is to examine factors who predict long-term effects of improved peak oxygen~     uptake one year after participating in cardiac rehabilitation.~      Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac~     rehabilitation program.~   "
61727|NCT02249247|"~     Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL~     284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety~     in patients with chronic obstructive pulmonary disease (COPD)~   "
61728|NCT02249234|"~     There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with~     scrotal pain that we found published.~      We proposed a pilot study using Botox to block the nerves on a small group of men with~     chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have~     had temporary relief from a testicular cord block using local anaesthetic drug.~      The encourage results of the pilot study has given us the background information to proceed~     with a formal randomised control trial of Botox vs placebo.~      We hypothesized that Botox injections to block the testicular nerve will be effective in~     providing long term pain relief for men with scrotal pain.~   "
61729|NCT02249221|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of~     GC3106 after single intramuscular administration in Korean healthy adults.~   "
61730|NCT02249208|"~     The purpose of this study is to determine the detection rate and the false negative rate of~     sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to~     radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant~     chemotherapy in patients with node-positive breast cancer converted to node negative after~     treatment by ultrasound. A randomized controlled trial.~   "
61731|NCT02249195|"~     Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with~     cardiovascular disease in 20 consecutive patients and will insert an implantable ECG~     monitoring device. The patient will then be followed up over a duration of two year and will~     be monitored for arrhythmia and mortality.~   "
61746|NCT02249000|"~     First-in-Human clinical investigation to evaluate the safety and clinical performance of the~     BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis,~     which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve~     implantation~   "
61732|NCT02249182|"~     This study will have two parts as follows:~      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and~     confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis~     C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the~     safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in~     HCV-infected pediatric participants.~      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate~     LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover~     into the Treatment Phase with no interruption of study drug administration. The Treatment~     Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/-~     Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.~   "
61733|NCT02249169|"~     This longitudinal study is being done to understand mechanisms underlying development of~     irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.~     This information will be used to determine whether temporal changes in gut microbial~     taxonomy and metabolism are associated with changes in symptom severity in IBS, and if~     targeted dietary interventions, including prebiotics, can reverse or moderate these changes.~   "
61734|NCT02249156|"~     Several employers in the US have introduced a program where their employees receive a~     financial incentive to receive lower cost care. Under this Rewards program, patients are~     free to choose providers but if they visit a pre-determined low-cost laboratory or radiology~     facility (called a rewards provider), they receive a financial incentive. The financial~     incentive is typically in the form of a Health Savings Account (HSA) contribution. The~     dollar amount varies by employer. This study will use medical claims data to examine if this~     program leads to an increase in the volume of services performed by low-cost providers and~     decreased health care spending.~   "
61735|NCT02249143|"~     The primary aim of this study is to quantify and compare changes in lung volumes (as~     measured by functional residual capacity) in premature infants stable on continuous positive~     airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air~     versus room air alone. We hypothesize that infants randomized to additional CPAP will~     demonstrate an increased functional residual capacity (at the end of the two week study~     period and prior to discharge) compared to those randomized to room air.~   "
61736|NCT02249130|"~     To investigate the safety of a standard triple therapy regimen of delavirdine (DLV),~     zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with~     regimens of tipranavir (TPV) with and without ritonavir (RTV)~   "
61737|NCT02249117|"~     Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of~     recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male~     volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of~     leukocyte, coagulation, platelet and endothelial activation will be quantified; To examine~     the safety of BIWH 3 in this setting~   "
61738|NCT02249104|"~     The goal of this study is to evaluate a complete topical acne regimen consisting of a~     prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®~     DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer~     SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne~     vulgaris.~   "
61739|NCT02249091|"~     Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several~     drugs with different ways of inhibiting the cell growth. In this trial, standard~     chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will~     be combined with a new drug called Selinexor.~      Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus~     which control the cell growth.~   "
61740|NCT02249078|"~     This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled,~     sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of~     E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized~     to one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The~     first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort~     will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within~     each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.~   "
61741|NCT02249065|"~     This study is designed to:~        1. assess the signs and symptoms of rosacea, including erythema, without treatment and~          during treatment with Mirvaso® gel~        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment~        3. gain a better understanding of the real-world use ofMirvaso® on the pattern and~          management of facial erythema of rosacea.~   "
61742|NCT02249052|"~     The purpose of this study is to determine whether collagenase is effective in reducing the~     surface area of a subcutaneous benign lipoma.~   "
61743|NCT02249039|"~     Critically ill infants and children who are mechanically ventilated are often given large~     doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs~     significantly cause tolerance and dependence, depresses the drive to breathe, and thus~     prolongs the need for mechanical ventilation and the associated complications. We propose IV~     CLON could be used as effectively as DEX.~   "
61744|NCT02249026|"~     Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for~     NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic~     treatment; those infants born to mothers with co-dependence on an opiate and a~     benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe~     in this population. If it is safe, we can include these infants in the large double blind,~     double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other~     hand, these infants have respiratory depression or other adverse events when buprenorphine~     is given, it will be important to report this study and caution the use of buprenorphine in~     these infants~   "
61745|NCT02249013|"~     This is a phase II open label, single arm clinical trial on safety and efficacy exploring an~     short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as~     upfront therapy for patients with advanced Epithelial Ovarian Cancer (EOC) undergoing~     Cytoreductive Surgery (CRS).~   "
61747|NCT02248987|"~     The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity~     according to the antipsychotic treatment response in schizophrenia.~   "
61748|NCT02248974|"~     The goal of this project is to develop a patient-centered decision aid for decision-making~     about end-stage heart failure treatment. This study seeks to create a decision aid that~     presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular~     Assist Device (LVAD) placement to help patients make values-based decisions about placement.~     The investigators propose a mixed methods design involving a literature search of clinical~     evidence, semi-structured patient interviews, and quantitative data from a multi-site trial~     of patients receiving the decision aid compared to patients not receiving the aid.~   "
61749|NCT02248961|"~     Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung~     Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),~     manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult patients~     with Grade I-II arterial hypertension in 12 weeks of therapy~   "
61750|NCT02248948|"~     This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving~     the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.~   "
61751|NCT02248935|"~     The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse~     from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y~     smartmesh lightweight mesh.~   "
61752|NCT02248922|"~     The purpose of the study is to evaluate lung clearance index (LCI) by a standardized~     procedure in a well characterized study setting and to assess feasibility of LCI as a more~     sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness~     of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung~     disease.~   "
61753|NCT02248909|"~     This study is an observational multicenter descriptive study. The study will be conducted in~     primary outpatient medical institutions in different cities of the RF. Primary care doctors~     who are primary contact for greater part of the population in RF including COPD patients~     will be invited as investigators. This observational descriptive study will be conducted~     within the routine practice of outpatient institutions. Since spirometry is not an integral~     part of the current all-round clinical practice, only those sites where spirometry test is~     routinely used in examination of patients with COPD risk factors and when monitoring~     condition of COPD patients will take part in the study. Thus the decision about spirometry~     in every study subject will be determined only by the existing treatment approaches.~   "
61754|NCT02248896|"~     The primary objective of this study was to assess whether there is an increased risk of~     sepsis with the use of telmisartan compared with other ARBs and with the other major~     antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A~     secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other~     three major antihypertensive classes and with untreated hypertension, is associated with an~     increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan~     compared with other ARBs, ACEIs and other major antihypertensive classes is associated with~     an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and~     death~   "
61755|NCT02248883|"~     To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect~     the QT interval more than placebo co-administered with ritonavir~   "
61756|NCT02248870|"~     Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to~     24 hours in patients with hip fracture would have a major impact in order to provide better~     preoperative analgesia for this group.~      In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone~     to the local anesthetics doubled the analgesic duration. No studies has investigated the~     effect of the addition of Dexamethasone to the femoral nerve block in patients with hip~     fracture.~      The aim of our study is to investigate if more patients with hip fracture experience lasting~     preoperative analgesia until the time of operation or 20 hours after a femoral nerve block~     with the addition of Dexamethasone compared to the same nerve block done without~     Dexamethasone.~   "
61757|NCT02248857|"~     The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS),~     which was designed as a strategy to standardize and simplify medication instructions to~     support safe and effective prescription drug use among diabetic.~   "
61758|NCT02248844|"~     This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness~     of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous~     glabellar lines.~   "
61759|NCT02248831|"~     Historically, ultrasound imaging of the lung parenchyma has been challenging because of the~     high total ultrasound energy attenuation and scattering by the air in the lungs. However,~     recent technological advancements have allowed for rapid assessment of various pulmonary~     diseases via the use of lung ultrasound. Furthermore, it has been shown that clear~     reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed~     Doppler ultrasound system incorporating a special signal-processing package.~      The LDS may contain information of significant diagnostic and physiological value regarding~     the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.~     In a pilot clinical validation study of patients with acute decompensated heart failure~     (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the~     normal Lung Doppler Signals (unpublished data). These are high velocity disorganized~     variable signals that are not synchronous with the cardiac cycle but rather sometimes with~     respiration.~   "
61760|NCT02248818|"~     This is a randomized, double-blind, placebo-controlled study of single and multiple~     ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day~     screening period, an in-house period during which AZD8108 or placebo will be administered~     orally as a solution, and a 4- to 10-day follow-up period after discharge.~   "
61761|NCT02248805|"~     The primary goal of this Phase 1 study is to characterize the safety and tolerability of~     MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered on either~     weekly or every three week schedules of administration among patients with metastatic~     colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of~     MGD007 will also be assessed.~   "
61762|NCT02248792|"~     Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe~     psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis,~     more so if disease is severe.~   "
61765|NCT02248753|"~     A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent~     reason for visits to the emergency department. Currently, in the majority of cases,~     immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation~     terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with~     rate-control medication only, and when needed cardioversion within 48 hours of onset of~     symptoms, could be effective, safe and more cost-effective than current standard of care and~     could lead to a higher quality of life.~   "
61766|NCT02248740|"~     The aim of this study is to perform a randomized, prospective trial comparing the two~     current methods of treatment for chronic venous insufficiency related to the Small Saphenous~     Vein (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if~     one is superior to the other.~   "
61767|NCT02248727|"~     The aim of this dispensing study is to evaluate the clinical performance of existing wearers~     of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily~     wear.~   "
61768|NCT02248714|"~     The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed~     type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS~     (continuous glucose monitoring system) and to further realize the safety and effect of~     Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.~   "
61769|NCT02248701|"~     The purpose of this study is to determine whether testosterone plus finasteride treatment~     will improve musculoskeletal health, neuromuscular function, body composition, and metabolic~     health in hypogonadal men who have experienced ambulatory dysfunction subsequent to~     incomplete spinal cord injury. The investigators hypothesize that this treatment will~     improve bone mineral density, enhance muscle size and muscle function, and improve body~     composition, without causing prostate enlargement.~   "
61770|NCT02248688|"~     The purpose of this pilot study is to achieve the collection of safety and efficacy data in~     patients undergoing left gastric artery embolization for morbid obesity in the United~     States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot~     study is not designed to achieve new indications for this device.~   "
61771|NCT02248675|"~     There is a strong association between sleep disturbance and suicidal thoughts and behaviors.~     Sleep disturbance is also highly comorbid with other common conditions associated with~     suicide such as depression and posttraumatic stress disorder. Accordingly, this application~     focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a~     broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral~     Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in~     Veterans who also suffer from additional conditions. The proposal further suggests that~     adding this sleep intervention to usual care may further enhance overall care by increasing~     the utilization of recommended treatments for depression and posttraumatic stress disorder.~   "
61772|NCT02248662|"~     Despite the large number of women affected, the optimal treatment strategy for DCIS is not~     known. To enable informed decision-making by DCIS patients, we seek to provide~     individualized data about outcomes following breast conserving-surgery with and without~     radiation therapy - in terms of recurrence, disease-free and overall survival, and~     likelihood of long-term breast conservation. To do this, we will study patient-specific risk~     factors for having a new breast cancer after DCIS and the likelihood of breast-conserving~     surgery versus mastectomy if a woman has a 2nd cancer diagnosis after DCIS and has not~     received radiation upfront, using 4 large datasets. The results of these analyses will then~     be combined into a model which will generate individually tailored predictions of the~     long-term likelihood of breast conservation with and without radiation therapy for DCIS. We~     will then design a web-based decision aid to present the tradeoffs and compare expected~     treatment outcomes with and without radiation therapy. This decision aid will enable~     patients and their physicians to choose the treatment most consonant with patient~     preferences, and will improve both the quality of decision-making and quality of life for~     patients diagnosed with DCIS.~   "
61773|NCT02248649|"~     This project is investigating whether a home-based exercise program will reduce cognitive~     decline in patients with Parkinson's disease.~   "
61774|NCT02248636|"~     This study tries to determine if stopping certain medications that are used to treat~     dementia will cause worsening.~      All of the participants will take pills that look identical, and that may contain active~     drug or an inactive pill (a placebo). Half of the group will receive the same treatment they~     were taking before the study -- this is called the sham discontinuation arm. The other~     half will receive a reduced dose of their medication, and then an inactive pill (placebo) --~     this is called the real discontinuation arm.~      Participants will be able to return to their previous dose of medication at any time during~     the study. The percentage of people who return will be measured and compared. Other medical~     events and factors such as behaviors, thinking, and caregiver distress, will be measured and~     compared between the groups.~   "
61775|NCT02248623|"~     A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience~     of surgery is the most secure way to prevent awareness with recall. Fortunately the~     incidence of awareness with recall (the patient can spontaneously remember the~     intraoperative event) is very rare (0.1-0.2%). However the investigators systematic review~     suggests that consciousness of intraoperative events may occur in approximately 37% of~     patients in experimental studies (as identified by the validated clinical procedure the~     isolated forearm test that does not require postoperative recall of the event). In this~     international cohort study, recruiting a minimum sample of 200 patients, the investigators~     will investigate the incidence of anaesthesia awareness (as identified by the isolated~     forearm test) following the induction of anaesthesia and before surgery.~   "
61776|NCT02248610|"~     In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators~     will collect real world data on their short and long term outcomes. The investigators~     hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment~     will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin);~     2. there will be less bleeding than when patients are on conventional anticoagulants; 3.~     there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary~     hypertension and post-thrombotic limb syndrome.~   "
86885|NCT01920126|"~     The purpose of study is to test whether perioperative sodium bicarbonate infusion can~     prevent acute kidney injury following open heart surgery in infective endocarditis patients.~   "
61777|NCT02248597|"~     This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in~     treating patients with hematological diseases. Giving chemotherapy before a donor stem cell~     transplant helps stop the growth of cells in the bone marrow, including normal blood-forming~     cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an~     immune response against the body's normal cells (called graft-versus-host disease). Giving~     cyclophosphamide after the transplant may stop this from happening.~   "
61778|NCT02248584|"~     The objective of this study was to evaluate the effects of supplementary antioxidant therapy~     on the levels of biomarkers and inflamatory citocines in patients with a previous history of~     non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,~     placebo-controlled trial. Patients were randomized into two groups, one receiving placebo~     (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50~     mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from~     patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,~     thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as~     well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two~     different times: (1) one day before the start of supplementation or placebo administration~     and (2) at 60 days after intervention. Statistical analyses were performed with the SAS~     System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures~     test.~   "
61779|NCT02248571|"~     This is a clinical trial with a crossover design to determine patients' preference for~     capecitabine in combination with bevacizumab or everolimus in combination with exemestane~     for advanced breast cancer patients and to evaluate, if any combination is associated with a~     better quality of life.~      To identify patients' preference for either therapy in this trial, patients without disease~     progression or other reasons for early discontinuation will be asked for their treatment~     preference and their treatment satisfaction. To correlate patients' preference with other~     patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and~     throughout the study, using dedicated questionnaires.~      With similarly active treatment options, it is of utmost importance to identify the~     treatment that has the least negative impact on the patients' quality of life.~   "
61780|NCT02248558|"~     Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote~     HIV testing among key populations such as men who have sex with men (MSM) and transgender~     (TG) individuals. The purpose of this randomized controlled trial is to compare the effect~     of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG~     in China. The crowdsourced video was developed using an open contest, formal transparent~     judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced~     video will be equivalent (within a margin of 3%) to a conventional video in terms of~     self-reported first-time HIV testing within 3-4 weeks of watching the video.~   "
61781|NCT02248545|"~     Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for~     wheat, barley, and rye) that primarily affects the small intestine in genetically~     predisposed patients and resolves with exclusion of gluten from the diet. Patients with CD~     show circulating autoantibodies (anti-transglutaminase, anti-tTG) and suffer from the~     destruction of a specific tissue cell type (the enterocytes) by CD8+ T cells. Furthermore,~     other autoimmune diseases have been reported in association to CD in 20-30% of the cases. In~     the last few year, a new clinical entity emerged, which seems include patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even~     though they do not have CD or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity (6), but, in a recent paper, the investigators suggested the~     term Non-Celiac Wheat Sensitivity (NCWS), since, to date, it is not known what component~     of wheat really causes the symptoms. The doubt areas about the NCWS regard also its~     pathogenesis as, despite some papers evidenced an intestinal immunologic activation, others~     excluded it. To explore the presence of autoimmunity in NCWS, the investigators evaluated:~     a) the frequency of autoimmune diseases and b) the frequency of serum anti-nuclear~     antibodies (ANA) positivity in newly diagnosed NCWS, compared to CD patients.~   "
61782|NCT02248532|"~     The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with~     chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is~     (1) on repetitive administration of cell therapy that would allow for long-lasting~     improvements in heart function and outcome in this patient population. In parallel, the~     investigators aim to (2) develop a standardized patient-specific stem cell product that~     could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used~     for therapeutic application when clinically indicated. By using a unique multimodality~     imaging platform, the goal of this project is also to (3) define standardized clinical~     criteria that would serve as a guideline for evaluation of the effects of stem cell therapy~     in future clinical trials and everyday clinical settings. Finally, to improve the clinical~     implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery~     technique that could be used to treat both left and right and ventricular failure and could~     be implemented in a standardized fashion designed for a widespread clinical use.~   "
61783|NCT02248519|"~     This is the first randomized controlled trial comparing laparoscopic and open gastrectomy~     for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic~     gastrectomy will result in a lower post-operative burden by means of shorter post-operative~     hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated~     with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better~     post-operative quality of life, with similar mortality and oncologic outcomes, compared to~     open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take~     three and five years respectively. Short-term results will be analyzed and published after~     discharge of the last randomized patient.~   "
61784|NCT02248506|"~     To determine proportion of women achieving clinical and mycological cure or have recurrences~     / reinfection after being treated for an acute episode of vulvovaginal candidiasis.~   "
62357|NCT02241057|"~     This is an open-label study. A total of approximately 60 subjects will be randomly assigned~     to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe~     or a heat patch (30 subjects) alone. The study will consist of 2 visits.~   "
61785|NCT02248493|"~     The purpose of this study is to define if intravenous paracetamol may improve analgesia and~     outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs~     (NSAIDs) postoperatively.~      Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV~     ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and~     adolescents following surgery.~   "
61786|NCT02248480|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.~   "
61787|NCT02248467|"~     The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible~     for bariatric surgery, the effect of testosterone replacement therapy in improving lower~     urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score)~     questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.~   "
61788|NCT02248454|"~     The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.~      Subjects will have several admissions during which the investigators will apply an iterative~     dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin~     ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The~     investigators hypothesize that the incremental insulin dose required to cover dietary fat in~     patients with type 1 diabetes will be related to total daily insulin dose (U/kg).~   "
61789|NCT02248441|"~     The present study will evaluate whether treatment with daily remote ischemic conditioning~     for a 28±4-day period induces beneficial effects in subjects with and without chronic~     ischemic heart failure in terms of improved left ventricular contractile function and~     exercise capacity.~   "
61790|NCT02248428|"~     Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple~     Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic~     regimens with new drugs. Clarithromycin may have partly efficacy in association with~     steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase~     3 clinical trial is proposed to explore whether clarithromycin could potentiate~     responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly~     Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by~     the combination of these drugs.~   "
61791|NCT02248415|"~     The aim of this study is to compare the effect of warm blood cardioplegia administration~     with and without roller pump on perioperative myocardial injury, reflected by postoperative~     biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a~     minimal extracorporeal circuit (MECC).~   "
61792|NCT02248402|"~     Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using~     dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple~     myeloma. Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded~     with the ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this~     study is to examine the safety and efficacy of Vax-DC/MM in patients with relapsed or~     refractory multiple myeloma.~   "
61793|NCT02248389|"~     The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity~     focused ultrasound to target and ablate tumors. It also does not require piercing the tumor~     with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also~     have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,~     there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging~     feedback could replace RF and Cryo for the treatment of small renal masses where the~     invasiveness of full resection partial nephrectomy is contraindicated due to patient~     comorbidities.~   "
61794|NCT02248376|"~     The primary purpose of the study is to compare efficiency of a non-stick gel application~     after scraping surgery for natural miscarriage with no non-stick gel application after~     scraping surgery.~      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy~     6-8 weeks after surgery.~   "
61795|NCT02248363|"~     Chronic pain is a common health problem that causes enormous social costs. A common method~     for treating patients with chronic pain problems are multimodal rehabilitation (MMR), which~     consists of a combination of physical exercise, cognitive behavioural therapy and work~     training coordinated in an interdisciplinary team. Our research aims to evaluate the~     effectiveness of MMR on health, quality of life, physical activity, return to work and~     health economics, with the long-term goal of developing MMR. We aim also to evaluate~     predictive factors for good and bad treatment outcomes in order to better adapt the MMR to~     the patient. The project is based on patient-reported data from the Swedish Quality Registry~     for Pain Rehabilitation, which routinely collects data from 35 Swedish specialist MMR~     clinics from all parts of the country. Physical activity will be assessed with advanced~     pedometer at random selected MMR clinics. We expect increased knowledge of treatment effects~     and how MMR can be effectively adapted according to the patient's limitations and resources.~     Our project group is interdisciplinary and is active in nationwide research networks that~     focus on chronic pain and rehabilitation.~   "
61796|NCT02248350|"~     This main purpose of this study is to examine the effects of an exercise intervention to~     counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate~     cancer patients. Specifically, a supervised and home-based exercise program will be used to~     assess its impact on clinical and behavioral variables related to ADT in prostate cancer~     patients.~   "
61797|NCT02248337|"~     Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel~     disease.~   "
61798|NCT02248324|"~     The purpose of this study is to determine whether common genetic polymorphisms that have~     been verified to be related to age-related macular degeneration (AMD) in some populations~     are also associated with AMD in Turkish population~   "
61853|NCT02247609|"~     Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy.~     Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which represents~     a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This~     study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal~     mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients.~   "
63051|NCT02231983|"~     Severe combined immunodeficiency (SCID), a rare primary immunodeficiency dieases (PID), is~     poorly characterized in mainland China. We meant to explore the patients with SCID refered~     to our hospital and summarize their clinical manifestations and genetic features.~   "
61799|NCT02248311|"~     Current methods based on traditional Cardiovascular risk factors are not clinically useful~     for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic~     events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in~     Type 2 Diabetes population have worse prognosis than in general population. In fact, there~     is sufficient experimental evidence indicating that diabetes exaggerates the deleterious~     effects of ischemic events and worsens their outcome.~      A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2~     Diabetes patients. Therefore, new strategies aimed at identifying those patients with this~     subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular~     events is a challenge to be met.~   "
61800|NCT02248298|"~     Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line~     treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative~     fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment~     of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is~     limited~   "
61801|NCT02248285|"~     BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel,~     a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common~     microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)~     from a stool specimen collected in Cary Blair enteric transport media. The test was made~     available for sale in the US and EU following FDA clearance and CE marking in May, 2014.~      The FilmArray GI Panel offers improvements over conventional laboratory testing which~     include: reduced turnaround time from specimen to result, reduced laboratory labor costs,~     increased sensitivity and specificity relative to current clinical reference methods, and~     larger breadth of organism identification than is available using standard methods. Because~     of these attributes, the results from this test have the potential to enable clinicians to~     more accurately diagnose and treat GI illness in a reduced time frame.~      Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics~     have designed a study to evaluate health outcomes of pediatric subjects presenting to~     emergency departments with GI illness before and after establishing the FilmArray GI Panel~     as the standard of care method for stool pathogen analysis. It is hypothesized that the~     rapid (~ 1 hour turnaround time), sensitive, specific, and comprehensive results provided by~     the FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate~     appropriate therapy and provide guidance when compared to the pre-implementation period.~   "
61802|NCT02248272|"~     This study investigated any potential associations between two isocaloric diets with~     different meal frequency (3 meals versus 6 meals) and glycemic control in people at high~     diabetes risk (lean and overweight/obese women with PCOS and individuals with~     hyperinsulinemia) and diagnosed with diabetes.~   "
61803|NCT02248259|"~     The objective of the current study is to evaluate the effect of once daily itraconazole on~     the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.~   "
61804|NCT02248246|"~     This is a prospective, non-randomized, single arm, multicenter, observational study to~     assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel~     sealing during laparoscopic colectomy. The study will not modify or influence current~     surgeon technique. Investigators will perform each procedure using the device in compliance~     with their standard surgical approach and product labeling.~      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in~     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,~     calibrated, and/or used in accordance with manufacturer design specifications, product~     instructions and guidelines.~   "
61805|NCT02248233|"~     Massive cerebral infarction is an ischemic stroke caused by complete blockage of the~     internal carotid artery, middle cerebral artery, or their cortical branches. The widespread~     infarction, pathological severity and high fatality rate associated with massive cerebral~     infarction pose a major threat to affected patients. However, there is a lack of unified~     diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral~     infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major~     brain-feeding artery is involved; the focal site affects more than two cerebral lobes;~     infarct diameter line ≥ 3 cm in internal capsule of striatum.~      Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain~     tissue, so the use of neuroprotective agents is very important. Remarkable progress has been~     made over the last decade in understanding the protective effect of calcium antagonists~     against cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist~     nimodipine selectively acts on cerebral vessels and neurons and can protect ischemic brain~     tissue, providing a new way of treating ischemic cerebrovascular disease.~      Preclinical and clinical tests have shown that nimodipine has a protective effect on~     ischemic brain tissue, and indicate that patients should take the drug as soon as possible.~     However, there are no reports of double-blind, randomized, controlled clinical trials~     addressing the administration of nimodipine via intravenous drip within the time window for~     successful treatment of acute massive cerebral infarction.~   "
61806|NCT02248220|"~     Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor,~     depression, anhedonia and tolerability~   "
61807|NCT02248207|"~     Study to obtain information about the co-operation of the different physician-colleagues in~     the treatment of patients with Parkinson's disease, both in private practices and clinics~     and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and~     to collect data on the tolerability of Sifrol® in ambulatory patients suffering from~     Parkinson's disease under routing conditions~   "
61854|NCT02247596|"~     The primary aim of our study was to examine the effects of two weeks of oral resveratrol on~     resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects.~     Secondary variables included plasma lipid subfraction, blood pressure and glycated~     hemoglobin (HbA1c).~   "
61858|NCT02247544|"~     This is an Italian, multicentre, single arm, phase II study, with an intra-patient~     comparison end point. This study aims at confirming the activity of the drug trabectedin as~     second/further line treatment in retroperitoneal leiomyosarcoma and well~     differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour~     growth.~      Another objective is to investigate this peculiar benefit of trabectedin in typical~     retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making~     in the management of retroperitoneal sarcomas~   "
61808|NCT02248194|"~     Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual~     blood ﬂow and heavy menstrual bleeding affects up to 30% of women at some time during their~     reproductive years. Abnormal menstruation can be due to conditions such as pregnancy~     complication uterine fibroids and adenomyosis, but in a large proportion of cases, the~     etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding~     (DUB). Treatment options for DUB include symptomatic medical treatment or surgery,~     traditionally hysterectomy.~      Hysteroscopically guided endometrial ablation methods have been shown to be effective and~     safe alternatives to hysterectomy for management of DUB. These methods require particular~     skills and experience and a long learning curve to be performed effectively and safely.~      Through the past three decades DUB patients in Assiut university hospital were treated with~     either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges~     during transcervical resection of the endometrium or rollerball coagulation, we used to~     shift to thermal balloon as backup method . However, expensive uterine balloon could not~     infrequently be afforded because of financial constrains and limited health resources .~     Therefore, another method was used as backup for hysteroscopic failures. It was first tried~     via insulating the conventional double-ended uterine curette then through a specially~     designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely~     similar to the dilatation and curettage procedure both principally and practically. Hence,~     the basic requirements for its performance are the general awareness with electrosurgical~     principles and adequate experience in performing dilatation and curettage. TEA is done by~     specially designed tactile diathermy probe that carried the job of electrosurgical ablation~     without hysteroscopy or distension media first in an experimental session that clearly~     clarified the reproducibility of the depth of thermal damage and safety of the tactile~     electrosurgical ablator . Thereafter, TEA was successfully performed with satisfactory short~     and medium term outcomes for ten cases with DUB during an active, relentless bleeding~     attack. TEA is done under laparoscopic monitoring.~      The aim of the present work is to present TEA as a simple, inexpensive, novel backup~     approach for treatment of DUB.~   "
61809|NCT02248181|"~     Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and~     dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms,~     assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and~     L-Dopa when given concomitantly.~   "
61810|NCT02248168|"~     The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as~     shown below through the Post Marketing Surveillance (PMS) study upon approval.~        -  Unexpected adverse events (especially, serious adverse events (SAEs))~        -  To find out the status of incidence of adverse events under actual practice~        -  Factors on the safety profile~        -  Factors on the efficacy profile~   "
61811|NCT02248155|"~     The objectives of this Post Marketing Surveillance (PMS) are:~        -  Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS)~          severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical~          Global Impression Improvement scale (CGI- I)~        -  Evaluation of the time to reaching maintenance dose of pramipexole~        -  Evaluation of work productivity impairment associated with RLS based on the Work~          Productivity and Activity Impairment Questionnaire (WPAI) questionnaire~   "
61812|NCT02248142|"~     Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I~     and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)~   "
61813|NCT02248129|"~     Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics~     and hypertensive with renal insufficiency (observed data) in the study population, with the~     objectives of the High Authority for Health recommendations (benchmark)~   "
61814|NCT02248116|"~     Safety and tolerability. Quality of life (EQ-5D, ACQLI) and health economic impact (health~     resource utilisation, living and employment status) assessments, will not be performed at~     the centers in the united kingdom (UK)~   "
61815|NCT02248103|"~     A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison~     with collagen membrane for management of periodontal intrabony defects.~   "
61816|NCT02248090|"~     This is a phase 1 open label multicentre study of AZD9496 administered orally in patients~     with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose~     with intensive safety monitoring to ensure the safety of patients. The study will determine~     the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic~     dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the~     safety, tolerability, pharmacokinetics and biological activity of AZD9496~   "
61817|NCT02248077|"~     This study is designed to demonstrate the outcome of complete ulcer closure of patients with~     Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary~     Care (UCC).~   "
61818|NCT02248064|"~     Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive~     pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home,~     from time to time patients still have low oxygen levels especially when walking which can be~     harmful.~      The investigators have designed a new system of delivering oxygen to overcome the above~     problem. The system measures the oxygen saturations of a patient and subsequently adjust the~     flow of oxygen to meet a pre-set oxygen saturation target.~      Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low~     levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with~     chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.~   "
61819|NCT02248051|"~     The main purpose of this trial is to demonstrate the safety, tolerability and~     pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient~     population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In~     addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.~   "
61820|NCT02248038|"~     The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable~     colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was~     not inferior to open surgery.~   "
61855|NCT02247583|"~     Prospective non-interventional non-controlled multicenter observational study to evaluate~     aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with~     an oral anti-cancer drug.~      The main objective of this study is to evaluate the patient perspective in the treatment of~     advanced renal cell carcinoma with an oral anti-cancer drug.~      The following aspects will be investigated:~        -  Intrinsic desire for information about treatment.~        -  Patient satisfaction with treatment information.~        -  Patient satisfaction with treatment.~        -  Medication adherence.~        -  Health-related quality of life.~        -  The role of different health care professionals in the treatment of RCC with oral drugs~      This study should reveal information necessary for the development of pharmacotherapeutic~     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug~     over a long period.~   "
61821|NCT02248025|"~     Fluid responsiveness in a context of circulatory failure can be assessed by different way.~     Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the~     available device are expensive and the analysis are delayed. Capillary refill time (CRT) is~     hampered by its variability. The investigators have developed a method to standardize the~     pressure, the length of compression and a computerized analysis to calculate the capillary~     refill time. This method enables accurate measure of CRT.~      The investigators will study if CRT variation induced by a passive leg raising (PLR) can~     predict CRT after a 500 ml Fluid Load.~      About thirty patients in circulatory failure with a continuous cardiac output monitoring for~     whom, the attending physician has decided a fluid load, will be included. hemodynamic~     parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters~     (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by~     sublingual video-microscopy) and capillary refill time measured on the thorax and on the~     gingival area will be recorded. Data collection will be made before and after a passive leg~     raising and after a 500 ml fluid load of crystalloids.~      Patients will be aposteriori sorted in two groups: responders and non responders, defined by~     the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after~     PLR to predict in which group each patient is classified will be investigate and receiver~     operative characteristic curve will be built. These results will be compared to the~     metabolic response, the macrocirculatory response, and the microcirculatory response.~   "
61822|NCT02248012|"~     To study the efficacy of everolimus combined with temozolomide as first-line treatment in~     advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as~     disease control rate (non-progressive disease) at 6 months.~   "
61823|NCT02247999|"~     Background:~        -  Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical~          cancer are caused by the human papillomavirus (HPV). HPV is more common in women who~          have the human immunodeficiency virus (HIV). India has one of the highest rates of~          women who have both cervical cancer and HIV infection.~        -  Cervical cancer can be discovered in early stages by screening for HPV infection.~          Researchers want to compare new cervical cancer screening tests for HIV-infected women.~          They also want to know more about how HPV can lead to cervical cancer in HIV-infected~          women. To do so, they will hold a study to screen HIV-infected women in India.~      Objectives:~      - To improve cervical cancer screening methods in HIV-infected women in India.~      Eligibility:~        -  Women at least 18 years of age who have HIV infection.~        -  Participants will be recruited from HIV-focused health care clinics in Pune and~          Chennai, India.~      Design:~        -  Participants will have a physical exam and medical history. They will provide a urine~          sample and proof of HIV infection.~        -  Participants will have a gynecological exam. This will involve a pelvic exam and Pap~          smear to collect cells for study. It will also involve a cervical exam to look for~          precancerous cells. Cervical tissue may be collected.~        -  Participants will also provide a blood sample for testing.~        -  Participants will return in 2 weeks for the test results. If there are signs of~          precancerous or cancer cells, participants will be referred to a doctor for treatment.~   "
61824|NCT02247986|"~     Background:~      - Disruptive behavior is a common problem for children and adolescents. It can be treated~     with some success with stimulant medicine. Researchers want to learn more about how this~     works.~      Objective:~      - To learn how the brain changes when taking the medicine methylphenidate for behavior~     problems.~      Eligibility:~        -  Children ages 10 17 with conduct disorder and/or attention deficit disorder.~        -  Healthy volunteers the same age.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants will have two 3-hour sessions at the clinic. Girls who are menstruating~          will have a pregnancy test before their scans.~        -  Visit 1: All participants will:~        -  Perform simple tests on a computer.~        -  Fill out a questionnaire along with their parent or guardian.~        -  Have an MRI scan. A magnetic field and radio waves take pictures of the brain.~          Participants will lie on a table that slides into a metal cylinder. A coil will be~          placed over their head. They will be in the scanner for 60 minutes, lying still or~          performing a simple task. They will practice the task before the scan. A computer~          screen will show them task information during the scan. The scanner makes loud knocking~          sounds. Participants will get earplugs. Their parent or guardian can stay with them~          during the scan.~        -  Only participants with behavior disorders will:~        -  Take a pill of the study medicine or placebo.~        -  Be monitored for any side effects.~        -  Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get~          the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.~   "
61825|NCT02247973|"~     The study is a phase II trial designed to evaluate the efficacy and safety of~     co-transplantation with bone marrow derived mesenchymal stem cells from related donors in~     alternative donor transplantation of severe aplastic anemia.~   "
61826|NCT02247960|"~     The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary~     catheter removal decreases the number of symptomatic urinary tract infections in patients~     after radical prostatectomy. In addition, the investigators aim to determine whether~     antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from~     antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The~     investigators also aim to identify specific populations that may be at higher risk of~     developing urinary tract infections with urinary catheter use after radical prostatectomy.~   "
61827|NCT02247947|"~     Proteomics is used to identify prognostic markers after CPR. Additionally neurological~     outcome should be estimated by specific protein alterations and affections of pathways.~   "
61828|NCT02247934|"~     The objectives of this qualitative study are to elicit concepts about symptoms that are~     important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts~     of symptoms on patients' day-to-day functioning.~   "
61829|NCT02247921|"~     Stroke is the second leading cause of mortality and disability among adults worldwide.~     Rehabilitation is an effective treatment for stroke; however rehabilitation services are far~     from adequate in China, especially in rural areas where the health and economic burden of~     disability from stroke is very high.~      The investigators propose to develop, implement, and evaluate an evidence-based~     caregiver-delivered stroke rehabilitation program designed to improve the physical~     functioning of disabled stroke patients in rural China.~   "
61830|NCT02247908|"~     The purpose of this randomized controlled trial is to determine whether graphic health~     warnings on cigarette packs are more effective than the existing Surgeon General's warning~     on cigarette packs at encouraging quit attempts. While previous experiments evaluating~     candidate graphic warnings have been informative, they have used psychological outcomes,~     such as attitudes or quit intentions, but not actual cessation behavior (e.g., quit~     attempts). Furthermore, they typically expose participants to warnings in controlled but~     artificial experimental settings for a short period of time, using much lower frequency and~     shorter duration of warning exposure than found in the real world. This study addresses~     these issues by evaluating the impact of warnings on quit attempts by randomly assigning~     smokers to have their cigarette packs labeled with either a graphic warning or a Surgeon~     General's warning for four weeks.~      Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs~     will be more likely to report a quit attempt in the 4 weeks of the study than smokers~     randomized to receive a Surgeon General's label on their cigarette packs.~      Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette~     packs will have higher quit intentions at 4 weeks than smokers randomized to receive a~     Surgeon General's label on their cigarette packs, controlling for baseline quit intentions.~   "
61831|NCT02247895|"~     Patients who are admitted to the intensive care unit and require mechanical ventilation~     frequently develop profound respiratory and limb muscle weakness. Studies show that the~     development of weakness during the ICU stay results in poor outcomes. Currently there are no~     treatments for this muscle weakness, but it has been suggested that this weakness might~     improve with physical therapy. Electrical stimulation is a method to provide direct~     stimulation to the muscles potentially enhancing function and improving strength. The~     purpose of this study is to test the hypothesis that neuromuscular electrical stimulation of~     the quadriceps muscle will improve muscle strength in patients who are critically ill on~     mechanical ventilation.~   "
61832|NCT02247882|"~     The purpose of this study is to determine whether education or aquatic physical therapy are~     effective in the treatment of osteoarthritis in Knee due to intensity of pain, function~     capacity, quality of life and kinetic.~   "
61833|NCT02247869|"~     Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD~     (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin~     Lymphoma.~   "
61834|NCT02247856|"~     Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are~     well-established, but couple to nebulization is still challenging. Aim: To compare~     radioaerosol pulmonary deposition and radioaerosol mass balance in the different~     compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet~     nebulizer (JN) coupled to NIV.Methods: It was a crossover study involving 9 stable moderate~     to severe COPD randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and~     phase 2(NIV+JN,n=9). Bronchodilators were delivered during NIV using a facemask (pressures~     of 12 cmH2O and 5 cmH2O - inspiratory and expiratory, respectively). Radioactivity counts~     were performed using a gamma camera and regions of interest(ROIs) were delimited. We~     determine aerosol mass balance from the lungs, upper airways, stomach, nebulizer, circuit,~     inspiratory and expiratory filters, and mask as a percentage.~   "
61835|NCT02247843|"~     This Phase I clinical trial will assess the safety and initial evidence for efficacy of an~     autologous transplant of lentiviral vector modified bone marrow for adults with severe~     sickle cell disease.~   "
61836|NCT02247830|"~     It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the~     prevention of radiodermatitis in patients with breast cancer or head and neck cancer~     undergoing radiotherapy.~      Prophylactic Trial will consist of a control group and two experimental groups, namely~     control group (usual care), Experimental Group 01 (usual care + topical application of the~     gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based~     cream).~      The doses used in the different compounds are being in test since february 2014 by a~     dose-response curve study, using 6 groups with three doses of urea cream and three doses of~     C. recutita gel.~      The study will be conducted at the Center for High Complexity Oncology at University~     Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly,~     according to established criteria to classify the effects of radiotherapy, which identifies~     grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group -~     RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria~     for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).~   "
61837|NCT02247817|"~     Cardiac resynchronization therapy has become one of the cornerstones of the treatment of~     heart failure. However, a large proportion of patients still fails to this type of therapy.~     This may be due to a suboptimal position of the left ventricular pacing lead, which may be~     caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video~     assisted thoracic surgery is more flexible and evades the venous system altogether,~     resulting in a much more favorable position of the pacing lead, with better treatment~     results as e consequence.~   "
61838|NCT02247804|"~     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in~     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month~     treatment period with an 8-month extended follow-up.~   "
61839|NCT02247791|"~     The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as~     an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following~     a displaced femoral neck fracture.~   "
61840|NCT02247778|"~     Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7~     to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness~     of this incision secondary problems like prolonged fracture healing, paresthesia of~     supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a~     mini-incision technique using an average incision length of 4cm.~      The aim of this study is to analyzed whether secondary problems following plate~     osteosynthesis of the clavicle correlate mit the length of the surgical access.~   "
61841|NCT02247765|"~     To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject~     population during motion over a specified saturation range.~   "
69151|NCT02152215|"~     The purpose of this study is to compare the clinical and histologic outcomes for acellular~     dermal matrix and resorbable membranes to determine if either provides a significant~     therapeutic advantage.~   "
61842|NCT02247752|"~     The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We~     spoke first from HBsAg healthy carrier , then from  asymptomatic carrier , last from~     HBsAg inactive carrier . This definition continue to be not totally consensual. A very low~     viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases~     and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status~     on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of~     alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40~     UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during~     a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some~     patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently~     normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in~     order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver~     cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant~     prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate~     HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion;~     will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of~     comorbidities on unexpected arrival of such events.~   "
61843|NCT02247739|"~     Primary Objective:~      To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of~     angioedema attacks in patients with HAE~      Secondary Objective:~      To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the~     prophylaxis of angioedema attacks in patients with HAE~   "
61844|NCT02247726|"~     The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein~     nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess~     the impact of maternal immunization on infant safety through one year of life.~   "
61845|NCT02247713|"~     A part retrospective, part prospective cohort study to assess the difference in 2-year~     overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative~     intent in low and middle income countries before and after a training intervention on the~     use of PET/CT for radiotherapy treatment planning.~   "
61846|NCT02247700|"~     Respiratory disorders are the leading cause of respiratory failure in children. Thousands of~     children are admitted to a pediatric intensive care unit each year and placed on mechanical~     ventilators. Despite over 40 years since the first pediatric-specific ventilator was~     designed, there has been no specific cardiopulmonary directed therapy that has proven~     superior. While mechanical ventilation is generally lifesaving, it can be associated with~     adverse events. There is evidence building to suggest that adopting a lung protective~     ventilation strategy by the avoidance of lung over-distension and collapse reduces death.~     Therefore, timely discovery of these two lung conditions is extremely important in order to~     mitigate the effects associated with positive pressure mechanical ventilation. The~     investigators research team has extensive research experience with a non-invasive and~     radiation free medical device called electrical impendence tomography (EIT). EIT is intended~     to generate regional information of changes in ventilation. Meaning it can detect this~     collapse and overdistension. This additional source of information could help fine tune the~     mechanical ventilator. A baseline of understanding of how often this occurs in the patients~     the investigators serve is required. Therefore the investigators propose an EIT observation~     study in their pediatric ICU patient population.~   "
61847|NCT02247687|"~     Management of participants with low-level persistent viremia~   "
61848|NCT02247674|"~     The investigators hypothesized that bilateral handgrip force training would result in~     significant improvements in paretic hand, arm movements and daily functional performances.~     In order to investigate whether the improvement of paretic hand could facilitate the motor~     recovery of paretic arm and functional performances, the investigators also hypothesized~     that motor recovery and functional performances improvements of paretic arm and hand have~     strongly correlation.~   "
61849|NCT02247661|"~     A prospective cohort study to compare the direct lateral and poster-lateral approach~     concerning abductor function. Patients admitted with a femoral neck fracture operated with a~     hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for~     inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers~     were excluded.~      Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1~     year postoperatively by clinical examination. Sample size were estimated to 30 patient in~     each group. Primary outcome variables were trendelenburg test, abductor strength measured~     with dynamometry, trochanteric tenderness measured with algometry and palptation.~   "
61850|NCT02247648|"~     The investigators hypothesize that the use of tramadol will reduce pain and analgesic~     consumption after arthroscopic shoulder surgery.~   "
61851|NCT02247635|"~     The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary~     lifestyle and the excessive intake of food among the risk factors that comprise it are~     located the obesity, hyperglycemia, dyslipidemia and hypertension.~      It has been observed that the interventions of lifestyle changes that promote weight loss~     through the practice of physical activity and intake of a hypocaloric diet, reduce the~     prevalence of chronic diseases such as Metabolic syndrome.~      Adherence is defined as the extent to which a person's behaviour - taking medication,~     following a diet, and/or executing lifestyle changes, corresponds with agreed~     recommendations from a health care provider. The World Health Organization has estimated~     that in developing countries, as in Mexico, less than 27% of people with chronic diseases~     will continue treatment as directed.~      Adherence to treatment of chronic disease is a multifactorial problem that includes not only~     patient-related barriers, but also providers of health services and social security systems~     themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic~     non-adherence to treatment will become a global problem even more serious.~      The purpose of this study is develop and implement a methodology to overcome barriers~     affecting adherence to treatment of women over 20 years with non-communicable diseases such~     as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact~     through various quantitative indicators such as weight loss or metabolic syndrome~     prevalence.~      This study will include two phases:~        1. Phase 1. Design. Qualitative methodology was used primarily to identify the barriers~          faced by individuals to adhere to treatment. From this methodology, we developed a tool~          to assess adherence to treatment of subjects with these conditions and then an~          intervention to improve it.~        2. Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180~          overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or~          hypertension. All study subjects will be randomized to a control group and~          intervention. The control group will receive a medical traditional clinical care. The~          intervention group will receive a lifestyle treatment with behavioral intervention to~          improve adherence for improve eating behaviors, physical activity and metabolic~          control.~   "
61852|NCT02247622|"~     PSC is a chronic cholestatic disorder. The investigators intend to study some telomere~     parameters and telomere length in order to predict a premalignant state.~   "
61862|NCT02247492|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and~     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in an all-comers patient population in daily clinical practice.~      Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the~     patient's body inflammation status correlates with the clinical outcome.~   "
61863|NCT02247479|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study evaluating the efficacy and safety of lampalizumab administered by intravitreal~     injections in participants with geographic atrophy (GA) secondary to age-related macular~     degeneration (AMD).~   "
61864|NCT02247466|"~     The purpose of this study is to investigate surgical work space and surgical conditions in~     patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The~     patients will act as their own control with evaluation of surgical work space and surgical~     conditions during both deep NMB and no NMB.~   "
61865|NCT02247453|"~     In the present project we propose a large prospective study in heavy smokers volunteers~     based on plasma miRNA profiling to assess its efficacy as a first line screening test for~     lung cancer detection.~      The study will be articulated in different phases: i) analysis of 1000 plasma samples of~     disease-free smokers already collected in our biological repository in the last two years~     ii) de-novo enrollment of 4000 smoking volunteers, collection of their blood samples and~     inclusion in a program of active surveillance on the basis of their miRNA risk profile iii)~     assessment of miRNA expression profile using a custom made microfluidic card containing the~     24 miRNA previously identified in the diagnostic signatures iii) bioinformatic analyses of~     miRNA ratios in the cohort in order to determine which individuals are in presence or will~     develop lung cancer and in particular the aggressive form of the disease iv) assessment of~     the best diagnostic and treatment algorithm for subjects with suspicious miRNA profiles v)~     functional validation of miRNAs as novel therapeutic targets using novel cellular~     genetically engineered models of transformation and patients' tumorgrafts models.~   "
61866|NCT02247440|"~     This is a study of HCV treatment using the standard regimen of pegylated-interferon plus~     ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment~     will be implemented in conjunction with gastro-enterologists/hepatologists by internists~     responsible for the participant's HIV treatment.~      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life~     threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected~     patients are at a higher risk of death compared to HIV mono-infected individuals, even if~     HIV replication is suppressed on antiretroviral treatment.~      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows~     fibrosis regression, improved clinical outcomes. In addition, individuals who have been~     cured are no longer contagious to other individuals, therefore widespread access to HCV~     treatment may contribute to the control of the HCV epidemic.~      A combination of injectable pegylated-interferon with oral ribavirin is currently the~     recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection.~     They are administered for 24 weeks in HCV mono-infected patients but need to be administered~     for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV~     protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in~     patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter~     treatment.~      PRIMARY OBJECTIVE~      1. To determine the percentage of patients according to genotypes with sustained virological~     response 6 months after treatment discontinuation (SVR).~      HCV TREATMENT~        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)~        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of~          anemia.~      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a~     first part (starting in August 2014) and 45 patients in a second part, depending on funding.~   "
61867|NCT02247427|"~     The purpose of this study is to determine clinical outcomes related to deactivation of~     Cardiac Resynchronization Therapy device in subjects with super response.~   "
61868|NCT02247414|"~     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and~     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic~     Splenectomy and Azygoportal Disconnection for Portal Hypertension~   "
61869|NCT02247401|"~     This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment~     naive and treatment experienced HCV GT4 subjects without or with compensated cirrhosis.~   "
61870|NCT02247388|"~     To study the efficacy of AB-CASI against standard of care in a randomized controlled trial~     in the Emergency Department.~   "
61871|NCT02247375|"~     Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.~   "
61872|NCT02247362|"~     One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q~     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for~     safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled~     study.~   "
61873|NCT02247349|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,~     immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in~     combination with nivolumab in patients with relapsed/refractory SCLC.~   "
61874|NCT02247336|"~     Family health history can help identify patients at higher than average risk for disease.~     There is no standardized system for collecting and updating family health history, using~     this information to determine a patient's disease risk level, and providing screening~     recommendations to patients and providers. Patients will enter their family health history~     into MeTree, a family history software program. The program will produce screening~     recommendations tailored to the patient's family health history. The investigators will~     examine whether this process increases physician referrals for, and patient uptake of,~     guideline-recommended screening for colorectal cancer.~   "
61875|NCT02247323|"~     The investigators are assessing the incidence of ovarian cancer in premenopausal women who~     were at moderate risk of malignancy with low CA125.~   "
61876|NCT02247310|"~     Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as~     well as the challenge to achieve high adherence to treatment, evaluating the benefits of any~     new measure to improve adherence is important. The data storage capabilities of the~     BETACONNECT device, including the automated recording of injections, will facilitate the~     collection of reliable data on patient's injection behavior and adherence, which should be~     unaffected by recall bias or reporting bias.~      To better understand the utilities of the new BETACONNECT device and characterize its~     contribution to adherence, we plan to prospectively follow-up MS patients using this device~     for 24 weeks. The study will take place in a real-life setting in Neurology centers across~     Europe.~   "
61877|NCT02247297|"~     This prospective, single centred cohort study evaluates the physiological course of the~     potentially novel biomarker PSP in pregnant women as well as its predictive role in the~     development of inflammatory complications during pregnancy.~   "
61878|NCT02247284|"~     The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™~     OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new~     software (glaucoma premium module) with the well established peripapillary RNFL thickness~     measurements in patients with primary open angle glaucoma.~   "
61879|NCT02247271|"~     This project is a partnership between the University of Victoria and the eleven Diabetes~     Health Centres in the Fraser Health Region of BC. The primary goal of this project is to~     evaluate the feasibility, viability, and effectiveness of using peer health coaches to~     assist persons with type 2 diabetes who are experiencing challenges in managing their~     diabetes. The University of Victoria will recruit and train sixty coaches with various~     cultural and socioeconomic backgrounds representing a community of practice. Coaches will~     also have type 2 diabetes and will have led or taken the Diabetes Self-Management Program in~     English, Punjabi or in Aboriginal communities. Training will also include navigating the~     health care system, accessing mandated health and employment- related services, importance~     of medication adherence and ability to understand health care instructions. Three hundred~     subjects with type 2 diabetes will be recruited by Diabetes Health Educators. Eligibility~     criteria for subjects include: adults with type 2 diabetes attending a Diabetes Health~     Centre, A1C over 8% within the past 6 months, and ability to speak English or Punjabi. A~     randomized controlled trial design will be used. After completing baseline measures subjects~     will be randomly allocated to a group which will get the coaches or to a control group.~     Measurements will again take place at six and twelve months. The Diabetes Coaches will~     provide assistance to subjects and their families for up to 6 months. A project community~     advisory committee comprised of the researchers, Diabetes Centre administrative staff,~     clinicians, coaches, subjects, key community leaders and representatives from the diabetes~     industry will meet every three months to guide implementation and sustainability.~     Qualitative research methods (i.e., focus groups and interviews) will be used to gather~     feedback, perspectives, and opinions of all the stakeholders.~   "
61880|NCT02247258|"~     The objective of this study is to evaluate if in the prevention of postoperative recurrence~     of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to~     delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by~     endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and~     surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.~   "
61881|NCT02247245|"~     To examine the effects of heart rate reduction on exercise capacity in control subjects and~     patients with chronic heart failure.~   "
61882|NCT02247232|"~     This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group~     comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical~     cancer on radiotherapy. The study will use a central randomization with a dynamic allocation~     using biased coin minimization.~   "
61883|NCT02247219|"~     The study aims at:~      Using Intervention mapping as a planning approach for behavior change intervention programs,~     based on an ecological approach to health and local community and user participation.~        -  Explore the behavioral change processes utilizing qualitative methods.~        -  Develop theory-based behavior change programs across different domain at healthy living~          centres.~        -  Evaluate the effect of behavior change intervention programs across different domains.~        -  Increase health providers` competence in effective behavioral change intervention~          techniques by networks and education seminars between municipalities and research~          groups.~        -  The programs will specifically target the underlying causes of chronic disease. The~          investigators will map the distribution of lifestyle habits among individuals and~          families. The investigators will also explore how lifestyle habits relate to known~          determinants of social health inequality, such as adverse previous experiences,~          participation in working life and low income.~        -  The investigators also intend to study if socioeconomic differences are of importance~          for entering or dropping out of HLC interventions, and the ability to sustain lifestyle~          changes. The investigators will do so by stratified analyses, or by using socioeconomic~          variables as determinants in effect analyses.~   "
61884|NCT02247206|"~     The purpose of this research is to examine the preliminary efficacy, feasibility, and~     acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette~     Syndrome through in a randomized waitlist-controlled trial.~   "
61885|NCT02247193|"~     Objectives: To determine if the use of botulinum toxin during primary cleft lip repair~     improves the cosmetic appearance of the scar~      Study Design: Double blinded randomized controlled trial~      Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months~     of age or younger with a unrepaired complete unilateral cleft lip and palate requiring a~     primary cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized~     sites in the cleft lip during surgical repair. Control subjects will receive a placebo~     injection in place of the toxin. Surgeons will be blinded to patients that receive the~     experimental injection. Outcomes will be determined using 3D-videography preoperatively and~     post operatively at scheduled visits with a total of one year follow up. A scar assessment~     questionnaire will be completed by parents at select post operative visits. Videography~     images will also be assessed by a blinded expert panel at the completion of the study.~   "
61886|NCT02247180|"~     This study aims to proof the efficacy of a cognitive rehabilitation program for patients~     with mild dementia in Alzheimers Disease with respect to activities of daily living.~   "
61896|NCT02247050|"~     This pragmatic trial examines the uptake and effects of primary care clinician commitments~     to follow 3 Choosing Wisely® recommendations. The investigators hypothesize that~     pre-encounter invitations to clinicians to commit to the recommendations will decrease~     ordering of: (1) imaging tests for low back pain, (2) antibiotics for acute sinusitis, and~     (3) imaging tests for headaches. The study is a mixed-methods, stepped wedge cluster~     randomized trial in which the intervention will be sequentially introduced to 6 clinics in~     southeastern Michigan in a randomly assigned order.~   "
61887|NCT02247167|"~     Sleep disordered breathing (SDB) is a common disease in both adults and children and is~     caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of~     paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main~     treatment option is adenotonsillectomy (AT). It is well known that obstructive sleep apnoea~     (OSA) in adults increases the risk for hypertension, coronary artery disease and stroke, and~     there is now mounting evidence that SDB also has a significant impact on the cardiovascular~     system in children with reports of elevated blood pressure, endothelial dysfunction and~     altered autonomic cardiovascular control.~      Oxidative stress seems to play a pivotal role in impairing flow-mediated dilation (FMD) and~     consequently enhancing cardiovascular risk in SDB patients but the underlying mechanism is~     still undefined.~      Previously, we demonstrated that endothelial dysfunction is directly related to NADPH~     oxidase activation. Furthermore, recently we assessed the association between OSA,~     endothelial dysfunction and oxidative stress in adults showing that increased NADPH~     oxidase-generated oxidative stress and arterial dysfunction are partially reversed by nasal~     continuous positive airway pressure treatment.~      There is evidence in literature that cardiovascular morbidities associated with SDB are~     potentially reversible in children; AT may have a significant role in reversing the~     cardiovascular sequelae of SDB (e.g. children with OSA).~      Nowadays, there aren't studies that analyzed the role of NADPH oxidase-generated oxidative~     stress in SDB children.~      The purpose of the current research project is to examine the role of NADPH oxidase~     activity, oxidative stress, inflammation and endothelial function in SDB children,~     understanding the mechanisms involved in this disease.~      Furthermore we will analyse the effect of a AT on inflammation, oxidative stress, NADPH~     oxidase activity and endothelial function in SDB children.~   "
61888|NCT02247154|"~     To determine:~        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency~          (PAD or SAD).~        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody~          deficiency.~        3. The half-life of Vigam® Liquid after 4 months of treatment.~        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®~          Liquid.~   "
61889|NCT02247141|"~     The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®)~     given subcutaneously by weekly infusion to patients with primary antibody deficiency.~      The secondary objective was to determine the safety of Subgam® given subcutaneously by~     weekly infusion to patients with primary antibody deficiency.~   "
61890|NCT02247128|"~     At present, a variety of antithrombotic regimens are prescribed in the early postprocedure~     period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy~     (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the~     recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to~     be inferior. In patients with atrial fibrillation (AF) or another indication for oral~     anticoagulation (OAC), no recommendations on best treatment regimen currently exist although~     triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.~      We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer~     and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC~     (cohort B).~   "
61891|NCT02247115|"~     The establishment of a number of training programs in therapeutic endoscopy, standardization~     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde~     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The~     length of training and minimum number of procedures, requisite theoretical learning and~     methodology to define competence in EUS and ERCP are not well defined. The investigators~     research has demonstrated that individuals in training acquire skills at different rates and~     the number of procedures completed alone is a suboptimal marker for competency in a given~     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed~     to performance metrics with well-defined and validated thresholds of performance.~     Multicenter prospective data are needed to help guide development of competency based~     medical education that define learning curves in EUS and ERCP and set evidence-based~     benchmarks required to achieve competence using a validated competency assessment tool.~      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment~     tool will allow for reliable and generalizable standardized learning curves, competency~     benchmarks and creation of a centralized national database that compares a trainee's~     performance amongst peers.~   "
61892|NCT02247102|"~     The study shall investigate whether isomaltulose~        -  is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as~          ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the~          postprandial period~        -  does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated~          as other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.~      It is hypothesized that isomaltulose, provided with a standard follow-on formula,~        1. will not significantly increase the mean basal breath H2-excretion rate (determined as~          the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial~          period compared to a sucrose containing standard follow-on formula.~        2. will not lead to a significantly different gastrointestinal tolerance in the~          conse-quent 24 h after formula consumption compared to a sucrose containing standard~          follow-on formula in infants aged 6 to 12 months.~   "
61893|NCT02247089|"~     Background:~      The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system~     (ANS), keep our body in a state of balance, which can be disturbed in situations of~     uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress~     with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular~     function. Furthermore, imbalanced autonomic profile is also associated with increased~     inflammation, a known risk factor for cardiac problems, diabetes, and cancer.~      Parasympathetic stimulation can control the inflammatory reaction, leading research toward~     interventions which can stimulate the cholinergic pathway. Among these interventions,~     massage therapy has shown to stimulate the PNS and bring back the balance within the body's~     organs.~      Objectives:~        1. To assess the physiological effects of night shifts on the ANS profile and bio-markers~          of inflammation and stress in blood~        2. To assess whether one session of massage therapy can revert the adverse effects of~          night shift via re-balancing these components.~      Methods:~      A pilot prospective randomized crossover trial with 10 healthy hospital staff is in~     progress:~      Each participants will be their own control. All participants will be measured for their~     baseline characteristics and outcomes of interest on a regular working day as well as at the~     end of 2 nights of shift work. At the end of one shift they will be randomly assigned to~     receive a 30-minute-long upper body massage, while at the end of the other shift they will~     receive a reading intervention which would serve as a control intervention. Randomization~     is done using a computer system that also verifies inclusion-exclusion criteria before~     allocating the intervention.~      The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV)~     captured by a state-of-the-art machine which non-invasively records electrical signals from~     the body. The inflammatory markers in the blood are also measured using top-notch laboratory~     technology.~      The results of the study will be reported by comparing the outcomes of each subject with~     their own baseline as well as comparing the two interventions for the effect of massage.~     Data will be pooled for all subjects in order to show the overall effect.~      The final results of this study will be used to plan stress management intervention trials.~   "
61894|NCT02247076|"~     The purpose of this study is to find out if meal timing affects calories burned and blood~     sugar levels.~   "
61895|NCT02247063|"~     The investigators are doing a study to learn about the effects of a type of low-energy~     non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints.~     Disorders in these joints are called temporomandibular joint disorders, or TMD.~   "
61897|NCT02247037|"~     This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as~     a reliable model for treatment response for individual patients with triple negative breast~     cancer. The collection of patient tumor tissue will also provide insight into the mechanisms~     of therapeutic resistance for those individuals. Ultimately, this study will enhance our~     understanding of the genomic basis for treatment response for triple negative cancer on an~     individual basis, while having the potential to suggest new therapeutic options for~     high-risk triple negative breast cancer patients with residual disease post neoadjuvant.~   "
61898|NCT02247024|"~     Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain~     intensity, sedation score, and other side effects of opioids. Measurements of the~     concentration of opioids and their active metabolites in blood.~   "
61899|NCT02247011|"~     This proposed study was designed to investigate the prevalence of a 5-year incident~     osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D~     (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the~     Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit~     of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and~     examined.~   "
61900|NCT02246998|"~     This study is to assess glomerular function before and during administration of stribild~     (STB; elvitegravir [EVG]/cobicistat [COBI]/emtricitabine [FTC]/tenofovir DF [TDF]) or a~     regimen containing TDF without COBI as ritonavir-boosted atazanavir (ATV/r) plus truvada~     (TVD; FTC/TDF) or atripla (ATR; efavirenz [EFV]/FTC/TDF) compared to a regimen containing~     neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual~     glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and~     estimated (calculated) glomerular filtration rate (eGFR). This study will assess tubular~     function before and during administration of stribild, ATV/r plus TVD, or atripla compared~     to a regimen of ATV/r plus ABC/3TC. This study will also evaluate the pharmacokinetics (PK),~     antiviral activity, efficacy, safety, and tolerability of the three treatment regimens~     through 24 weeks of treatment.~   "
61901|NCT02246985|"~     Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are~     responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers~     and orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important~     for the human body as precursors of vitamin A. They are also thought to be important as~     anti-oxidants and may help protect against cancer and heart disease. Although many foods are~     rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed~     and available for metabolism in humans.~      Devising practical ways and means of increasing carotenoid bioavailability could lead to~     better health outcomes. Processed foods are now widely eaten by many, both for their taste~     and convenience. No studies have thus far looked at the bioavailability of carotenoids that~     have been added into processed foods. Thus the purpose of this study is to investigate the~     bioavailability of carotenoids that have been incorporated into processed food products~     (bread and mayonnaise).~   "
61902|NCT02246972|"~     The proposed study is designed to test the clinical efficacy of the BRAVEMIND military~     sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45~     users.~      The following hypotheses will be tested:~        1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with~          posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates~          that are similar to existing Prolonged Exposure (PE) therapy delivered in military~          samples (20-40%) and by the absence of any critical incidents.~        2. Participants in the VRET group will show statistically and clinically meaningful~          reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician~          Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and~          psychophysiological measures) following treatment.~        3. Participants in the VRET group will show statistically and clinically meaningful~          reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological~          measures) compared to wait-list results.~   "
61903|NCT02246959|"~     In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and~     cost-effectiveness of improving cholesterol levels among participants who are at high risk~     of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes~     financial incentives. Participants will use electronic pill bottles that continuously~     monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12~     months.~   "
61904|NCT02246946|"~     The purpose of this study is to determine if the addition of intermittent positive airway~     pressure breathing (specific lung expansion technique) to conventional chest physiotherapy~     chest drainage is effective to accelerate the reabsorption of pleural effusion and~     consequently decrease the duration of chest tube drainage and respiratory system impairment.~     These effects would decrease hospital stay lengths and the incidence of pulmonary~     complications.~   "
61905|NCT02246933|"~     This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the~     negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation~     responses. Half of the participants will receive a high polyunsaturated fat diet )50%~     carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty~     acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the~     other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%~     carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated~     fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total~     energy will be saturated fatty acids.) for 7 days.~   "
61906|NCT02246920|"~     This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been~     designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray,~     50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone~     propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of~     Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be~     tested for superiority against a placebo nasal spray.~   "
61907|NCT02246907|"~     The purpose of this study is to evaluate the impact of an exercise intervention on~     patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia~     patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia~     patients.~   "
61908|NCT02246894|"~     The main objectives of this study are:~        -  to assess Optivate® consumption (IU/kg consumed per month for prophylactic and~          on-demand therapy and dose at each bleed).~        -  to assess clinical outcome when treating a bleed with Optivate®.~        -  to evaluate Optivate® in terms of clinical tolerance and safety in children under the~          age of 6 years. .~        -  to assess FVIII inhibitor development during the study.~   "
61909|NCT02246881|"~     The main objective of the study is to compare the pharmacokinetics of Optivate® with the~     subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary~     objective is to compare the first and second pharmacokinetic assessments on Optivate® (and~     recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance~     and safety.~   "
61910|NCT02246868|"~     The main objectives of this study are to compare the first and second recovery assessments~     and recovery when a subject changed batch and to assess whether haemostasis was achieved~     with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical~     tolerance and safety of Optivate®.~   "
61911|NCT02246855|"~     The main object of the study is to compare the AUC0-84, of a single intravenous infusion of~     Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up~     to 3mL/min and up to 6mL/min).~   "
61912|NCT02246842|"~     The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's~     D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.~   "
61913|NCT02246829|"~     Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for~     patients suffering from neovascular age-related-macular degeneration.1 This early dramatic~     reduction in CRT is already observed through week 4. Therefore it might be not necessary to~     consistently perform each of the three monthly consecutive intravitreal injections of the~     so-called loading phase.~   "
61914|NCT02246816|"~     MP-101 will be evaluated in this study to see if it is safe and tolerable.~   "
61915|NCT02246803|"~     The aim of this study is a comparative evaluation of progression of paroxysmal atrial~     fibrillation in patients with coronary artery disease after isolated CABG and CABG combined~     with pulmonary vein isolation.~      Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery~     disease after CABG in combination with isolation of the pulmonary veins have a better~     outcomes for the progression of AF compared with patients undergoing isolated CABG.~   "
61916|NCT02246790|"~     Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and~     biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.~      Hypothesis of the study - patients with long-standing persistent atrial fibrillation and~     coronary artery disease after CABG in combination with biatrial RFA have a better outcomes~     for the freedom of AF compared with patients undergoing left atrial RFA during CABG.~   "
61917|NCT02246777|"~     The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS™~     Glaucoma Filtration Device (Ex-PRESS) in Japanese patients with normal tension glaucoma.~   "
61918|NCT02246764|"~     The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil~     (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active~     comparator Timolol Maleate Ophthalmic Solution, 0.5%.~   "
61919|NCT02246751|"~     Little is known about how children with cerebral palsy (CP) use their sensory systems~     (touch, sense of body position, balance organs in the inner ear, vision) to help them~     achieve trunk control for independent sitting. If a child with CP does not achieve trunk~     control by 4 years of age their prognosis for motor skill development including walking is~     poor. Clinical researchers at The Movement Centre in Oswestry, England have developed a~     method called Targeted Training in which children train trunk control in small segments from~     the top down using a custom fit training device. This study aims to examine how children~     with moderate to severe CP use sensory information for trunk control before, during and~     after a program of Targeted Training.~   "
61920|NCT02246738|"~     Purposes are to determine whether various cohorts of bladder cancer patients have detectable~     tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see~     if tCTC's provide novel information.Study population are various cohorts of patients~     diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw,~     up to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will~     be collected at each blood draw.~   "
61921|NCT02246725|"~     In this trial, patients with cancer in the upper gastrointestinal canal who are going to~     receive first line palliative chemotherapy and patients with colorectal cancer who are going~     to receive second line palliative chemotherapy will be included. Participating patients will~     be randomized between early contact with a palliative care unit, or contact with a~     palliative care unit when needed. The objectives with the trial is to investigate if an~     early establishment with a palliative care unit will have a positive impact on the patients~     quality of life, this also applies for the nearest relative, survival, and if a difference~     in numbers of chemotherapy cycles can be detected.~   "
61922|NCT02246712|"~     This study aimed to investigate the influence of uncontrolled type 1 and type 2 diabetes~     mellitus (DM) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics~     of tramadol enantiomers in patients with neuropathic pain. Thus, nondiabetic patients~     (control group, n = 12), patients with type 1 DM (n = 9), and patients with type 2 DM (n =~     9), all with neuropathic pain and phenotyped as extensive metabolizers of cytochrome P450~     2D6 (CYP2D6) who were treated with a single oral dose of 100 mg racemic tramadol were~     investigated.~   "
61923|NCT02246699|"~     The prevalence of overweight and obesity is getting more and more important in developed as~     well as in emerging countries. It can be defined according to the degree of fat storage by~     measurement of fat mass.~      No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a~     fungal chitosan from the mycelium of non-genetically modified Aspergillus niger.~     KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.~      The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical~     device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body~     weight reduction after 3 months of intake in overweight and obese men and women.~     Furthermore, effects on anthropometric measurements, body fat mass percentage, serum lipids~     and safety parameters will be investigated.~   "
61927|NCT02246647|"~     Our overall objective with this study is firstly to provide a comprehensive assessment of~     intestinal permeability, mucosal barrier function using existing biomarkers and secondly to~     explore novel biomarkers for measuring intestinal permeability in patients with constipation~     predominant Irritable Bowel Syndrome (IBS-C).~   "
61928|NCT02246634|"~     Patients diagnosed with colorectal cancer routinely undergo a CT scan to identify whether~     the cancer has spread to other parts of the body, but diagnosis of secondary cancer in the~     liver is difficult using conventional CT. MRI is known to be better than CT at diagnosing~     cancer in the liver but it takes a long time to do. Recently it has been suggested that~     limited MRI of the liver can identify most cancer in the liver, however this has not yet~     been proven to be effective in patients with a new diagnosis of colorectal cancer. The~     purpose of this study is to test whether a quick MRI scan of the liver at the time~     colorectal cancer is diagnosed can identify more cancer that has spread to the liver than~     conventional CT.~      All patients who have been diagnosed with a high risk type of colorectal cancer but no liver~     metastases on CT will be eligible to take part in the study.~   "
61929|NCT02246621|"~     The main purpose of this study is to evaluate how effective nonsteroidal aromatase~     inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.~     Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.~   "
61930|NCT02246608|"~     This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure~     Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to~     the wound prior to activating the NPWT.~   "
61931|NCT02246595|"~     The trial enrolls patients with early severe sepsis or septic shock displaying at least one~     newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal~     infection. The primary goal of the trial is to assess the pharmacokinetics and~     pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and~     tolerability as well as evaluate parameters of efficacy.~   "
61932|NCT02246582|"~     The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168~     hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G~     Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.~   "
61933|NCT02246569|"~     For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for~     the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After~     the insertion of the coils distended lung sections shrink so that healthy parts can expand.~      In the present study investigators intend to examine, whether the insertion of the coils~     improves diaphragm function and force of the breathing muscles. Investigators hypothesize~     that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves~     breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.~   "
61934|NCT02246556|"~     This is a randomized, masked, controlled study of the effect of a virtual reality,~     binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with~     amblyopia.~   "
61935|NCT02246543|"~     This study will have the primary aim to investigate within-day changes in appetite after~     consumption of high-protein (HP, 30% of calories) and normal, or low, protein (LP, 15% of~     calories) whey protein meal, in solid and liquid form, on appetite and ad libitum food~     intake. Secondary objective will be to assess the statistical relationship between plasma~     concentrations of gut hormones and visual analogue scales (subjective hunger and fullness)~     and transit time.~      In order to investigate the interaction of food structure and protein content on appetite,~     this requires, in practice, either a differing amount (g) or calorie (kJ) load as a function~     of energy density (defined as kJ/100g). Delivering the test meal as a solid and liquid form~     gives an easy solution to achieve this manipulation without compromising the nutritional~     profile. Following on from this decision, it is easier to produce different preloads using~     whey protein (rather than meat protein), since it is easily incorporated into test meals.~   "
61936|NCT02246530|"~     The goal of this project is to identify an effective and conservative approach to treating~     partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical~     correction needed.~   "
61937|NCT02246517|"~     Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine~     block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also~     have antagonist property of NMDA receptors. The investigators hypothesize that prolonged~     treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic~     neuropathy, post herpetic neuralgia etc.).~   "
61938|NCT02246504|"~     The purpose of this study is to evaluate thyroid nodule's volume, structure and~     vascularisation changes following HIFU therapy assessed by ultrasonography~   "
61939|NCT02246491|"~     This research is being done to better understand the causes of the disease~     Ataxia-Telangiectasia and, in the longer-term, develop new therapies for the disease using~     stem cells.~      Induced pluripotent stem cells (iPSC) are a type of cells that can be made in the laboratory~     from cells in your body, such as blood cells or skin cells (fibroblasts). These stem cells~     can then be used for research purposes. For example, stem cells can be used to investigate~     how the mutation in ATM causes the actual symptoms of Ataxia-Telangiectasia. In addition,~     the stem cells can be used to screen for drugs that could be helpful to treat the disease or~     to develop new laboratory techniques to correct the mutation that causes~     Ataxia-Telangiectasia. where the mutation that causes the disease is corrected by the~     investigators. The stem cells generated in this study will not be used directly for patient~     therapy and therefore this research does not have a direct benefit to you. However, it will~     help advance our understanding of the disease and develop future therapies.~      Patients who enroll in this study will get all of the standard therapy they would get for~     their tumor whether or not they participate in this study. There is no extra or different~     therapy given. The study involves a one-time procedure (either blood collection or skin~     biopsy).~   "
61940|NCT02246478|"~     The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in~     patients with Duchenne Muscular Dystrophy.~   "
61941|NCT02246465|"~     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the~     recurrence of hypertrophic scar formation following elective revision of a pre-existing~     hypertrophic scar.~   "
87379|NCT01913626|"~     assessing the Efficiency of cognitive group therapy for patients with subjective memory~     complains, using the neuropsychological computerized assessment of WebNeuro by Brain~     resource (BRC).~   "
61942|NCT02246452|"~     The main objective of this study was the assessment of the nutritional status of children~     and adolescents aged between 0-18 with malignancies based on BMI percentiles and standard~     deviation scores, at diagnosis, during treatment and during a period of two years after the~     end of therapy.~   "
61943|NCT02246439|"~     Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg~     Bimodal Release Tablets) for Acute Gastroenteritis.~      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute~     Gastroenteritis, by comparing it to placebo.~   "
61944|NCT02246426|"~     This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled~     clinical trial to assess the efficacy of an experimental software program targeting social~     cognitive abilities versus a computer-based software control. Both the study and the~     software being investigated meet the criteria of Non-Significant Risk.~   "
61945|NCT02246413|"~     The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical~     and cost effectiveness and implementation potential of a primary care integrated~     multicondition intervention program to help improve mood and weight for obese adults with~     clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation~     added to the main trial with funding through the NIH common fund for the Science of Behavior~     Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial~     participants will be consented to undergo additional assays evaluating neurobiological~     mechanisms of self-regulation.~   "
61946|NCT02246400|"~     The eCMP Pilot aims to study the feasibility and potential effectiveness of an~     electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change~     among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.~   "
61947|NCT02246387|"~     Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique~     in the investigators department and the Manchester operation the preferred procedure. The~     investigators long-term reoperation rates for pevic organ prolapse are very low, as~     documented in the investigators previous long-term follow-up study (Oversand et al,~     International Urogynecology Journal 2013), however the data were retrospective and patients~     with avulsions of the levator ani muscle were not identified. The investigators hypothesize~     that correct fixation and elevation of the vaginal apex, as part of a three-compartment~     repair procedure, is essential in the POP surgical repair, also when treating women with~     levator ani avulsions.~      The purpose of this study is to:~        -  prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the~          3-compartment Manchester procedure) gives an adequate elevation and fixation of the~          vaginal apex.~        -  assess changes in subjective symptoms between the preoperative evaluation and the 1 and~          5-year postoperative evaluations.~        -  evaluate whether the patients identified with levator avulsions in the investigators~          population have an increased risk of failure (objectively and subjectively).~   "
61948|NCT02246374|"~     This is primarily a safety protocol to evaluate the safety of unilateral subthalamotomy~     using Transcranial ExAblate in a staged, escalating dose titration manner; Stage I is~     subtherapeutic; Stage II is full, therapeutic unilateral lesioning.~   "
61949|NCT02246361|"~     The purpose of this before-after prospective multicenter study is to assess the impact of~     six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and~     adherence scale for common acute illnesses in emergency ward.~   "
61950|NCT02246348|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package; i.e. the transthoracic~     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS signals~     that are related to pulmonary hypertension.~      The TPD performance in detecting PAH in SSc patients will be assessed in the study.~   "
61951|NCT02246335|"~     Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of~     displaced femoral neck fractures in the elderly-elderly~   "
61952|NCT02246322|"~     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe,~     and effective technique for obtaining samples from the GI wall lesions and from organs~     adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G~     and 19G. Some studies have suggested that the 25G needle could be equal or even better than~     the 22G needle.~      The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for~     testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles~     types, 25G and 22G.~   "
61953|NCT02246309|"~     Embryoscopes, allow for embryo culture to be performed in an automated incubation system~     under time lapse photography. Manufacturers of these systems (and investigators who have~     used these systems) claim that the availability of 24-hour time-lapse photographic control~     improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They~     also claim that use of this system saves laboratory personnel time.~      This study will randomize approximately 120 patients (60 in each arm) to standard embryo~     culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time~     spent by the laboratory personnel with each system. Secondary endpoints will be IVF~     outcomes.~   "
61965|NCT02246153|"~     -  Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC)~          has been supported by high-quality evidence, and the high-level evidence for advanced~          gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG~          0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid~          evidence of laparoscopy-assisted distal gastrectomy for the treatment of advanced~          gastric cancer (AGC).~        -  China has entered the aging society since 1999. Among the GC patients in China, the~          average age is 65 years old, which makes increasing attempts to explore laparoscopic~          techniques in the treatment of elderly patients.~        -  Nowadays, a considerable proportion of elderly patients suffer from multiple diseases,~          such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative~          and postoperative complications can not be ignored. Unfortunately, there are rare~          studies specializing into the LAG for the GC patients of > 65 years old.~        -  Accordingly, the comparison of intraoperative and postoperative complications between~          laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with~          gastric cancer based on a randomized controlled trial is warranted.~   "
61954|NCT02246296|"~     Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high~     mortality in Africa. This is partly because children are commonly brought for admission~     because they are seriously ill, rather than being brought to hospital because of~     malnutrition alone. Mortality rates are especially high where SAM is complicated by HIV or~     TB. The early phase of inpatient nutritional treatment for severe acute malnutrition is~     based on a low-protein milk known as F75, which is given to improve metabolic homeostasis~     prior to the re-feeding to achieve catch-up growth. F75 provides a high proportion of energy~     from carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of~     different types of carbohydrates, but lactose in particular, is known to occur in SAM and~     may lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated~     with increased mortality. Furthermore, switching from a catabolic state to a high energy~     diet that consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may~     lead to severe electrolyte abnormalities and multiple organ dysfunction.~      The aim of this trial is to determine whether reducing the carbohydrate content of F75, and~     removing lactose, improves the stabilisation of severely malnourished children. The trial~     will involve randomising children who are eligible to receive F75 milk to either the current~     formulation or a revised formulation. Both formulations will be given according to current~     recommendations regarding frequency of feeding and caloric value. Since the purpose of F75~     is to stabilise the child metabolically and biochemically, the primary endpoint of the trial~     will be time to stabilisation (the end of the first phase of treatment for severe acute~     malnutrition). Blood and stool samples at admission and after three days will be used to~     determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding~     syndrome. Children will be followed up until discharge from hospital. The project has been~     planned in consultation with the World Health Organisation (WHO) and, if the revised~     formulation of F75 results in improved outcomes, will lead to a global change in~     recommendations for its formulation.~   "
61955|NCT02246283|"~     The elderly demographic is on the rise - and this includes elderly living with~     schizophrenia. Yet very little is known about their lives, how they cope with their~     condition and how it develops over time.~      Research in this patient-group is sparse; overall there seem to be a tendency for elderly~     patients to manifest fewer psychotic symptoms and experiencing an increase in the~     psychological quality of life with older age. Opinions are divided on the degree and extent~     to which this tendency reflects remission and/or recovery in older patients.~      In order to identify factors associated with a positive outcome we:~        -  Investigate the course and the outcomes of the illness over the lifespan, as well as~          the life course and outcomes.~        -  Investigate the current status of mental and physical health, quality of life as well~          as functional competence of elderly (55+ yr) with schizophrenia.~      Also the investigators~      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type~     1 diabetes (a chronic somatic illness).~      This study will yield vital insights into how schizophrenia develops over time, isolating~     factors that determine how well patients fare. The perspective is to advance knowledge of~     elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the~     interventions offered to this group.~   "
61956|NCT02246270|"~     Urinary Tract Infections (UTIs) are the second most common infection in the body. UTIs~     account for five percent of all visits to primary care physicians. UTIs are less common in~     men than women. Many women who have had a UTI will develop recurring urinary tract~     infections. Recent studies suggest that some women who suffer from recurrent UTIs have~     urinary tracts that allow bacteria to adhere to it more readily than others. Women who~     suffered from bladder inflammation and recurrent UTIs were noted to have reduced UTIs and~     bladder inflammation with heparin bladder instillations. Heparin is a highly-sulfated~     glycosaminoglycan and stored within the secretory granules of mast cells and released only~     into the vasculature at sites of tissue injury. It has been proposed that, in addition to~     anticoagulation, the main purpose of heparin is defense at such sites against invading~     bacteria and other foreign materials. The central question the research is intended to~     answer is does Heparin bladder instillations decrease UTI rates in patients.~      Primary Objectives: The specific aims of this study are to 1) demonstrate that Heparin~     bladder instillations reduce the number of UTI episodes; 2) demonstrate Heparin bladder~     instillations increase median intervals between UTI; and 3) demonstrate that Heparin bladder~     instillations decrease urine inflammatory (NGAL) levels. Study Design: This study will be a~     randomized, double-blind, placebo-controlled trial of subjects treated for documented~     recurrent urinary tract infections with heparin bladder instillation versus sterile saline~     instillations. The study recruits women (n = 30) with 3 or more UTI episodes in one year~     from the patient population at OHSU and randomly assigns them to treatment as usual care~     with sterile saline instillation (n =15) or treatment as usual with heparin bladder~     instillations (n = 15). Subjects are given 6 weekly bladder instillations with interval~     follow-ups; the primary outcome measures are number of UTI episodes during the six month~     study period and a survival analysis assesses time to the next UTI. The usual care of this~     study is antibiotic treatment for UTI only. Urine samples will be collected at certain~     intervals. Analysis: We will seek a statistically significant difference of the recurrent~     UTI rate for 6 months between heparin instillation and sterile saline instillation group.~     Assuming Recurrent UTI rate of sterile saline bladder instillation is 2.3.3 UTI episodes per~     six months, a 35% reduction in the recurrent UTI rate is deemed significant based on~     previous literature. A sample size 30 (15 for each group) will achieve 60% power to detect a~     35% reduction in recurrent UTI rate at a 0.05 significance level. Allowing for a 25% drop~     out, a total of 30 subjects will be required. Significance: Recurrent UTIs are challenging~     to manage, especially if microbiological results are equivocal. In women who suffer from~     frequent recurrences, daily antibiotic use is the most effective strategy for recurrent UTI~     prevention compared to daily cranberry pills, daily estrogen therapy, and acupuncture.~     However even with this traditional approach of continuous antibiotic for 6 to 12 months, the~     rate of UTI was only reduced during prophylaxis and the rate of UTI was unchanged after~     stopping antibiotic treatment. Increasing antibiotic resistance rates require immediate~     identification of innovative alternative prophylactic therapies. The lack of non-antibiotic~     therapies gives an opportunity to develop innovative strategies to decrease recurrent UTIs~     and decrease the burden of UTIs. This study will augment the current evidence available on~     the aggregate effects of a treatment that emphasizes the optimization of both antibiotic~     regimens and non-antibiotic interventions.~   "
61957|NCT02246257|"~     The primary aim of our present study is to evaluate the effect of a targeted, intensified,~     multidimensional intervention compared to conventional treatment of modifiable risk factors~     for CVD in patients with early RA. The primary endpoint, a composite of death from~     cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be~     assessed after 5years' follow-up.~   "
61958|NCT02246244|"~     Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in~     France since 2002.~      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary~     regarding the tumor localisation, the population, intensity of the symptoms...~      Incidence of ENT cancer is highly significant in France, it is one of the most important in~     the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of~     depression is the most important (22%-57%).~      Researches appears necessary to assessed the efficacy of antidepressant treatments with as~     primary objective not only the decrease of depressive symptoms but also an ensemble of~     physic and psychological symptoms.~   "
61959|NCT02246231|"~     Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both~     ears. As a result of the tumours themselves or the treatment of the tumours, many patients~     become profoundly deaf in both ears. It is possible to restore a degree of hearing by~     placing a hearing implant in the brainstem adjacent to the hearing pathways within the~     brain. This is termed an auditory brainstem implant (ABI).~      The aim of this study is to find the optimum head position in relation to the MRI magnet~     field, which would produce least area of image distortion in patients with ABIs. This will~     be of benefit in optimising the MR imaging in future patients with implants.~   "
61960|NCT02246218|"~     This is an open-label study consisting of a transition period to RAVICTI, followed by a~     safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI,~     depending on age at enrollment. It is designed to capture information important for~     evaluating safety, pharmacokinetics and efficacy in young children.~      Subjects who are followed by or referred to the Investigator for management of their UCD or~     assessment of high blood ammonia may be eligible for this study. Subjects eligible for this~     study will include patients ranging from newborn to < 2 years of age with either a diagnosed~     or clinically suspected UCD.~   "
61961|NCT02246205|"~     The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,~     DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for~     DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE~     after pancreaticoduodenectomy.~   "
61962|NCT02246192|"~     The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the~     healing process of the wound, when compared with the usual technique of daily local healing.~     The investigators propose the objective of evaluating the efficacy of intra- and~     postoperative application of plasma rich in growth factors, to reduce healing time and~     complications, arising from its removal, compared to the standard surgical treatment.~   "
61963|NCT02246179|"~     The purpose of this study is to assess the efficacy of fractional CO2 laser assisted~     delivery of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine~     10 μg/ml solution and EMLA cream) regarding to anesthesia of the skin.~   "
61964|NCT02246166|"~     This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,~     single-dose study will assess the efficacy and tolerability of the active tablets versus~     placebo in participants suffering from cold and influenza. Eligible participants will be~     randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a~     four-hour (hr) treatment phase. Each participant will be administered only once during each~     study period. Participants will use a questionnaire to record the symptom severity scores as~     described, as well as time.~   "
61967|NCT02246127|"~     The purpose of this study is to elucidate which sequence of streptozotocin (STZ) based~     chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives~     better results in terms of second Progression Free Survival (PFS) in well differentiated and~     advanced pancreatic NETs.~   "
61968|NCT02246114|"~     Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant~     women. Investigators hypothesize that more regular self-monitoring, text messages and~     feedback as provided by home carbon monoxide monitoring device combined with medical~     feedback on results will reduce smoking during pregnancy compared to only receiving text~     message and no self-monitoring by home monitoring device and no feedback by home carbon~     monoxide monitoring device . The periconceptual period is a life period, where given the~     immediacy of the fetus and future child, a pregnant woman is willing to try and modify~     potentially harmful behaviors.~   "
61969|NCT02246101|"~     Environmental toxins exert damaging health effects in workers. Thousands of responders who~     worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following~     the September 11, 2001 attacks suffer from health conditions or may be at increased risk for~     worsening health. In a pilot study, investigators identified the first evidence of kidney~     damage in subjects with very high exposure at Ground Zero. Specifically, noted was a~     preliminary association between the intensity of particulate matter exposure and~     albuminuria, a marker of early chronic kidney disease (CKD), systemic endothelial~     dysfunction, and increased cardiovascular risk.~      The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among~     individuals exposed to inhaled toxins. The primary objective of this research is to quantify~     the risk of kidney damage among first responders to the WTC attack and to determine the~     relationship to particulate matter exposure as well as determine an association between~     renal and cardiovascular damage in first responders and to explore potential mechanisms. The~     central hypothesis is that exposure to inhaled particulate matter causes systemic~     inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular~     damage. This hypothesis will be investigated in a subgroup of participants from a previously~     conducted NIOSH-funded study Pulmonary Function Abnormalities, Diastolic Dysfunction and~     WTC Exposure: Implications for Diagnosis and Treatment (WTC-CHEST, PI Mary Ann~     McLaughlin).~      The proposed study will capitalize on unique resources in WTC-CHEST, including the~     standardized collection of data on particulate matter exposure and shared risk factors for~     CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this~     proposal is anticipated to have a broad impact on understanding the health effects of~     inhaled particulate matter.~   "
61970|NCT02246088|"~     Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes~     great disability and significant healthcare costs. Substantial scientific evidence indicates~     a role for central sensitization in OA pain. Reconceptualization of pain through~     Neuroscience Education (NE) is an intervention that has already been used successfully in~     some chronic musculoskeletal pain conditions characterized by alteration on CNS pain~     processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome,~     widespread pain and chronic whiplash associate disorders).There is compelling evidence that~     NE have a positive effect on pain, disability, catastrophization and physical performance~     for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA~     patients are essentially lacking.~      The primary aim of this study is to assess the effect of NE on pain, disability and physical~     performance in subjects with chronic OA knee pain waiting for replacement surgery. This will~     be the first time NE will be addressed specifically to OA pain. To investigate the benefits~     of NE on pain related to knee OA, the effect of a manual therapy intervention combined with~     NE (MT+NE) will be compared with this same manual intervention plus an educational program~     based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary~     aims will be addressed as well:~        -  Examining the effects of the two interventions on the mechanism of central~          sensitization in patients with knee OA;~        -  Examining the effects of the two interventions on pain catastrophizing, illness~          perceptions and kinesiophobia in patients with knee OA;~        -  Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.~   "
61971|NCT02246075|"~     The purpose of this study is to evaluate the safety of 2 fixed doses of EVP-6124~     hydrochloride (HCl) compared to placebo for 24 weeks in subjects with mild to moderate~     Alzheimer's disease who are concurrently receiving stable treatment with memantine and~     currently receiving stable treatment or previously treated with an acetylcholinesterase~     inhibitor.~   "
61972|NCT02246062|"~     Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience.~     Among the strategies for reducing children's anxiety, non-pharmacological strategies are as~     important as the pharmacological ones, but their its validity is still controversial.~      Objectives: The aim of this study is to verify if the information provided to relatives as~     well as and smartphone application provided to children interferes in prevalence and level~     of child preoperative anxiety.~      Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective~     surgical procedures and their relatives are randomly allocated into four groups: control~     group (CG) where the relative received conventional information about anesthesia; info group~     (IG), relative received an information leaflet about anesthesia; device group (DG), relative~     received only conventional verbal information and the child received smartphone application~     immediately before entering the operating room; device and info group (DIG) relative~     received a leaflet containing information and the child received smartphone application.~     Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale~     (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and~     at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and~     Mann-Whitney tests for prevalence and level of anxiety in the groups.~   "
61973|NCT02246049|"~     The purpose of this study to assess efficacy and tolerability of combination therapy~     FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic~     colorectal cancer.~   "
61986|NCT02245880|"~     Intubation must be done with utmost care in cervical trauma patients. cervical spine motion~     must be minimized and intubation must be fast. The aim of this study was to compare the~     effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients~     undergoing elective surgery were enrolled in this trial. After standard monitorisation~     including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with~     propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were~     divided into two groups glidescope and fastrach. Rigid collar was placed then patients were~     intubated with one of these devices. Mask ventilations with or without collar were recorded.~     insertion times, intubation times of the devices were recorded. Peroperative hemodynamic~     parameters and postoperative minor complications were also recoded.~   "
63052|NCT02231970|"~     Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations~     achieved by surgical sleeve gastrectomy.~      The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the~     treatment of patients with obesity~   "
61974|NCT02246036|"~     For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a~     very common complication yielding high morbidity and mortality. Inadequate regional~     perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main~     cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock~     but there are still lacks of information about the regional perfusion. This leads to late~     MODS diagnostics preventing the implementation of adequate treatment.~      Gut perfusion monitoring seems to be a good target to assess the microcirculation but,~     nowadays, no practical methods or devices are available to measure the gut perfusion, and~     the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).~      MC Monitor trial is a prospective, multi-center pilot study, enrolling 10 patients.~      The probe will be used by intensivists on ICU patients with a risk of shock and requiring~     mechanical ventilation.~      The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist~     (standard procedure for post-pyloric tubes placement). This procedure will be used to assess~     the status of the gut mucosa prior to the placement of the APD probe.~   "
61975|NCT02246023|"~     After randomization, the subjects undergo flexible bronchoscopy either with fractionated~     propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,~     oxygen saturation, and oxygen requirement are measured continuously during the procedure and~     thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted~     continuously during and after the procedure.~   "
61976|NCT02246010|"~     The purpose of this study is to determine whether lactose-free milk will shorten the~     diarrhea duration and decrease its severity in formula-fed infants presenting to the~     Emergency Department (ED) or pediatric clinics with acute diarrhea.~   "
61977|NCT02245997|"~     The purpose of this study is to give 12T a smaller dose of radiation in order to decrease~     these late side effects.~   "
61978|NCT02245984|"~     Compare the clinical competence of undergraduate nursing students' of mashhad nursing and~     midwifery school in two groups applying nursing process (paper- based versus electronic).~   "
61979|NCT02245971|"~     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc~     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a~     time-consuming procedure that requires a high level of endoscopic skill to achieve a~     desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum~     of lesser curvature side is difficult. Because the antrum of lesser curvature side is~     dependent position, irrigated water and blood may prevent visual field of ESD.~      Generally, whole precutting around the lesion during the ESD is performed prior to~     dissection. However, it is expected that partial precutting method for the lesion located in~     the antrum of the lesser curvature may improve the visibility of ESD because it can help us~     the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time~     of ESD for the lesion located in the antrum of the lesser curvature according to the~     precutting methods (whole precutting vs. partial precutting).~   "
61980|NCT02245958|"~     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins~     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of~     Cervical Dystonia and Blepharospasm in clinical practice.~   "
61981|NCT02245945|"~     The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1%~     gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the~     BAT24 regimen.~   "
61982|NCT02245932|"~     The overall objective is to investigate the efficacy of resveratrol in modulating metabolism~     and CVD risk profile in patients with COPD. The primary objective is to investigate the~     effect of resveratrol on CRP as clinical marker of low grade systemic inflammation. The~     secondary objective is to investigate the effect of resveratrol on body composition,~     inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a~     comprehensive assessment of metabolicand physical performance profile known to be affected~     by low grade systemic inflammation and by resveratrol.~   "
61983|NCT02245919|"~     Up to now, only little research has been performed inn tailoring treatment of patients with~     chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial~     intervention in patients with a moderate to high level of disability and in whom the~     contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).~     Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary~     rehabilitation settings but might also benefit from treatments based on these~     multidisciplinary rehabilitation treatment principles when provided by specifically trained~     primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate~     the feasibility of a specifically for primary care physiotherapist developed biopsychosocial~     intervention (Back on Track intervention) in WPN3- classified patients, and to evaluate~     whether this Back on Track intervention results in a significant improvement in functional~     disability in this subgroup of patients.~   "
61984|NCT02245906|"~     The purpose of the study was to investigate how Brazilian fruits peel affect~     acute/postprandial glucose and insulin responses, inflammatory markers, appetite control~     peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual~     analogue scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel~     added to a standardized meal will improve postprandial glucose tolerance and other metabolic~     biomarkers in healthy volunteers, compared with a similar meal without the corresponding~     plant materials.~   "
61985|NCT02245893|"~     This study evaluates fracture healing, anatomic reduction and return to functioning in~     patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when~     a good alignment of the ankle joint is maintained and natural function of the syndesmosis~     (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is~     stabilized by a series of ligaments which are often damaged in Weber C type fractures.~     Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically~     reconstruct the ligaments. The investigators will compare reconstruction of the unstable~     syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with~     anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a~     syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be~     compared between the groups using validated outcome measures.~   "
88692|NCT01896362|"~     The aim of this work was to investigate the healthcare professionals' knowledge about~     leishmaniasis in Divinópolis, an endemic county of Minas Gerais state, Brazil.~   "
61987|NCT02245867|"~     The purpose of this study is to examine the tolerance, safety, pharmokinetics, and possible~     clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive~     chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis.~      The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first~     patient will receive the starting dose of the antibody and, if tolerated, the following~     patients will each receive (if tolerated) progressively higher doses of the antibody.~     Patients in part 1a of the trial will receive only one infusion of the drug. Patients~     treated in the phase 1a part receive lower dosage which might not be effective.~      Once the maximal tolerated dosage is established during the phase 1a part, the investigators~     will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions,~     once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed~     no toxicity can be also treated in the part 1b of the trial. The first patient will receive~     the starting dose of the antibody and, if tolerated, the following patients will each~     receive (if tolerated) progressively higher doses of the antibody. When the investigators~     reach the maximum tolerated dose without toxicity, the investigators e will enroll another 4~     patients to receive the same dose. If there are no toxicities, another 4 patients will be~     treated at the next dose level, and so forth. Patients treated in Phase 1b may receive lower~     dosages which might not be effective. The goal of Phase 1b is to establish the tolerance and~     possible beneficial effects of 11-1F4. If successful, treatment with this antibody would~     represent a novel approach in the care of individuals with AL amyloidosis.~   "
61988|NCT02245854|"~     Colorectal cancer is a major cause of morbidity and mortality in Western countries.~     Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC~     incidence and mortality.~      Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel~     perforation, so that a careful balance between efficacy and safety appears to be clinically~     relevant.~      Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions,~     which represent over 90% of all the polyps.~      To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy~     techniques - i.e. without electric current - by means of biopsy forceps or snare, have been~     proposed.~      Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of~     electrocautery may result in an increased risk of bleeding. The safety of cold-snare~     polypectomy has however been recently shown in controlled trials.~      Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have~     assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual~     disease), and no studies have compared it to conventional polypectomy.~      The investigators perform this study to assess both the efficacy and safety of a novel snare~     (Exacto™) for polyp removal.~   "
61989|NCT02245841|"~     This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous~     manifestations in patients with refractory classic dermatomyositis, juvenile~     dermatomyositis, and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will~     be both safe and effective for such patients.~   "
61990|NCT02245828|"~     This is a double blind, randomized, placebo controlled, single and multiple ascending dose~     study in healthy subjects. Safety evaluation will include (serious) adverse events, vital~     signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be~     drawn at specified timepoints.~   "
61991|NCT02245815|"~     The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its~     effect over the secreting immunoglobulin A in the feces with the use of probiotics of the~     strain Boucardii vs. Multispecies in premature newborns weighting less than 1500 g.~   "
61992|NCT02245802|"~     This study aimed to validate CU prediction model on mortality for patients with high risk~     bleeding peptic ulcers after therapeutic endoscopy.~   "
61993|NCT02245789|"~     Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic~     induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a~     conventional MacIntosh laryngoscope.~      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a~     videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that~     it modifies the anesthetic drugs requirement. .~   "
61994|NCT02245776|"~     The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy~     in incurable neurological disorders.~   "
61995|NCT02245763|"~     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world~     outcomes related to the transcatheter mitral valve repair and replacement (TMVR) procedure.~     Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology~     (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure~     for the treatment of mitral valve disease.~   "
61996|NCT02245750|"~     In the current study the investigators hypothesize that Routine Hysteroscopy prior to~     IVF/ICSI cycle increases the clinical pregnancy rate.~   "
61997|NCT02245737|"~     The purpose of this study is to assess the efficacy and safety of LY3314814 compared with~     placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study~     will test the hypothesis that LY3314814 is a disease-modifying treatment for participants~     with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive~     impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of~     the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease~     Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2~     LY3314814 treatment groups compared with placebo.~   "
61998|NCT02245724|"~     The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy~     in mental retardation.~   "
61999|NCT02245711|"~     The purpose of this study was to study the effect of stem cell therapy on Limb Girdle~     Muscular Dystrophy patients.~   "
62000|NCT02245698|"~     The purpose of this study was to study the safety and effect of stem cell therapy on the~     functional recovery in patients with sub acute/chronic stroke.~   "
62022|NCT02245412|"~     The objectives of this trial are to evaluate the safety, tolerability,~     pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in~     subjects with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI)~     tract.~   "
62001|NCT02245685|"~     This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of~     the plan underlines the need to improve practices and access to opioid substitution~     treatment. Priority 3 stresses the importance of articulation and coordination between~     specialized structures and community medicine to optimize the quality of care and to ensure~     continuity in the followup of these patients. This study focuses on the followup of patients~     under substitution therapy from the moment they enter a specialized care center for addicts~     to the period they are monitored by a general practitioner outside the specialized care~     center. The assessment described in this study should allow to harmonize and keep a~     continuity in patient monitoring.~   "
62002|NCT02245672|"~     The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when~     administered by inhalation in adult asthma patients~   "
62003|NCT02245659|"~     Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in~     pregnant patients with sleep-disordered breathing and gestational diabetes~   "
62004|NCT02245646|"~     This study aims at capturing for the first time at which frequencies and sound intensities~     hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of~     patients perceiving these sound distortions and the length of time over which the~     distortions occur are assessed.~   "
62005|NCT02245633|"~     The aim of this research is to study how vitamin D affects various aspects of the disease~     process, such as inflammation, coagulation (ADAMTS13 and WVF) and miRNAs, in Diabetic kidney~     disease hemodialysis patients.~      Diabetes mellitus (DM) is one of the most common chronic diseases in nearly all countries.~     Diabetic kidney disease (DKD) traditionally has been referred to as diabetic nephropathy and~     is one of the microvascular complications of diabetes. Diabetic kidney disease (DKD) occurs~     in 25%-40% of patients with diabetes .~      Some studies have shown that the high risk of cardiovascular disease in diabetic patients~     with nephropathy is associated with increased plasma levels of von Willebrand factor (VWF)~     and decreased ADAMTS13 levels. VWF is a glycoprotein that plays an important role in~     platelet thrombus formation, whereas ADAMTS13 is a proteolytic enzyme that is responsible~     for degradation of large multimers of VWF released in the plasma by endothelial cells and~     platelets. Patients with both chronic kidney disease and diabetes have been shown to have~     higher plasma levels of VWF and decreased ADAMTS13 activity compared to healthy controls.~      Increased plasma levels of VWF, which reflects damage to endothelial cells and a~     hypercoagulability state, have been reported in atherosclerosis and diabetes. Thus, VWF and~     ADAMTS13 seem to be important players in the interface between diabetic nephropathy,~     hypercoagulability and atherosclerotic cardiovascular disease. Vitamin D deficiency is a~     risk factor for DM and hypertension. The investigators previous studies showed that adding~     calcitriol (activated vitamin D) to endothelial and vascular smooth muscle cells~     significantly down-regulated the inflammatory response of gene and protein expression~     involved in the nuclear factor kappa-light-chain-enhancer of activated B cells (NFĸB) signal~     transduction pathway. Micro RNA (miRNA) are short noncoding RNAs, 22-25 nucleotides long. As~     an endogenous production transcript, miRNAs can bind to the 3 untranslated regions (3 UTR)~     of its target messenger RNA (mRNA) in an imperfect, complementary manner, leading to~     post-transcriptional gene silencing. As a result, miRNAs can inhibit gene expression via~     mRNA degradation, translation inhibition, or transcriptional inhibition.The critical role of~     miRNAs has been established in several cellular and biologic processes, such as~     proliferation, differentiation, and development, and in the regulation of genes related to~     immune responses, cancer, and insulin secretion. MiRNA are involved in various biological~     processes and become novel biomarkers, modulators and therapeutic targets for diseases such~     as cancer, atherosclerosis, and DM.~      Significance: The high prevalence of cardiovascular morbidity and mortality in patients with~     DM on chronic hemodialysis remains a significant clinical problem and the finding of~     potential new biomarkers should be further investigated. This study aims to establish a link~     between ADAMTS13, VWF miRNA expression and vitamin D levels that can contribute to the~     development of new treatments for hemodialysis patients with diabetes.~      Methods: Each hemodialysis patient with diabetes in the investigators institute will be~     asked to participate in the study. After explaining the research goals, patients that agree~     to participate will sign an informed consent. The investigators estimate that the study will~     include 70 patients. Each patient will be assessed by a physician and 4 vials of blood will~     be taken while the patient is connected to the dialysis machine. The blood will be sent to~     the laboratory to check: 1) chemistry; 2) 1-25 vitamin D and 25- vitamin D levels; 3)~     ADAMTS13 activity and VWF; and 4) miRNA extraction. The patients will be grouped according~     to vitamin D levels (deficient /sufficient), and ADAMTS13, VWF and miRNA expression will be~     compared between the groups.~   "
62006|NCT02245620|"~     This study will be a Phase 2, randomized, double-blind, placebo-controlled study, enrolling~     40 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether~     the administration of MTP-131 will change either hand skeletal muscle energetics or muscle~     performance in age-related skeletal muscle mitochondrial dysfunction.~   "
62007|NCT02245607|"~     This is a randomized study to compare Compensatory Cognitive Training (CCT) versus~     Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.~      Study hypotheses: Compared to those who receive RT, study participants receiving CCT will~     show significant improvement in neurocognition, functional capacity, self-rated functioning~     and clinical measures.~   "
62008|NCT02245594|"~     In this study we would like to clarify the effect of long lasting Crohn's Disease on~     motility of the gastrointestinal system in patient and the effect regarding sleep~     disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector~     (Motilis Medica, Schweiz) and the well known polysomnographic equipment.~      Our hypothesises are:~      Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have~     abnormal colonic transit (primary endpoint).~        1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms~          have abnormal gastric emptying and small intestinal transit (secondary endpoints).~        2. Total and segmental transit times found in patients with CD will be compared with~          corresponding transit times in healthy volunteers found in a previous study.~        3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.~        4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or~          colonic CD in remission and sleep disturbances.~   "
62009|NCT02245581|"~     Patient characteristics, duration of surgery, and infusion volumes will be compared between~     the groups. Oxygen transport and organ function will be compared Length of hospital stay,~     morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed~     using the student t-test and discrete variables will be analyzed using Chi-Square test.~     P-value <0.05 will be considered significant, where appropriate 95% confidence intervals~     will be calculated. Statistical analysis will be carried out using standardize statistical~     programs SPSS 12.0 for windows.~   "
62010|NCT02245568|"~     The purpose of this study is to provide subjects who have completed participation in a Phase~     2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term~     safety of TRx0237.~   "
62011|NCT02245555|"~     Study to describe Tamsulosin prescription characteristics in a representative population of~     patients on treatment for benign prostatic hyperplasia~   "
62012|NCT02245542|"~     Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS®~     -treatment with special respect to nocturia~   "
62013|NCT02245529|"~     The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving~     patients treated with Secotex® (Tamsulosin) in real life settings. The aim of a PEM is to~     monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic~     Hyperplasia as used in general practice~   "
62014|NCT02245516|"~     The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25%~     ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal~     fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.~   "
62015|NCT02245503|"~     The objectives of this post marketing surveillance study were to document the comorbidity~     and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign~     Prostatic Hyperplasia).~   "
62016|NCT02245490|"~     Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity~     in patients with LUTS suggestive of BPH and relevant storage symptoms~   "
62017|NCT02245477|"~     In this study we explore To explore the role of maternal serum vascular endothelial growth~     factor (VEGF) in pregnancies complicated by foetal growth restriction.~   "
62018|NCT02245464|"~     The objective of this PMS study was to monitor and assess the safety of Micardis tablets in~     patients with hypertension over a period of 6 years~   "
62019|NCT02245451|"~     The primary objective of this study is to characterise the effects of tipranavir 500 mg and~     ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of~     methadone administered as a single dose in healthy adult volunteers~   "
62020|NCT02245438|"~     Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir~     (RTV) (TPV 750 mg/RTV 200 mg and TPV 500 mg/RTV 100 mg), administered twice-daily, on the~     pharmacokinetics of Norethindrone-Ethinyl Estradiol (NET/EE) 1 mg/ 0.035 mg administered as~     a single dose.~   "
62021|NCT02245425|"~     This study is designed to compare the short-term effects of two different thoracic spine~     thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability~     in people with neck pain.~      The null hypothesis is that there will be no differences between the two manipulation~     techniques for short-term effects on neck range-of-motion, pain, and self-reported~     disability in people with neck pain.~   "
62023|NCT02245399|"~     The purpose of the study is to assess whether a Mediterranean-type weight-loss diet,~     enriched with canola oil, high in plant protein, and low in carbohydrates will produce blood~     sugar control, reduce coronary heart disease (CHD) risk factors and maximize weight loss,~     better than conventional higher carbohydrate diets in overweight diabetic patients.~   "
62024|NCT02245386|"~     To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean~     section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and~     to study the effect of mode of delivery on female sexual function.~   "
62025|NCT02245373|"~     Major Depression (MD) is highly prevalent and has associated a high burden and economic~     costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).~      Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by~     NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.~      Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC~     center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring~     (n=150) and B) pharmacological treatment (n=150).~      Patients will be followed-up for one year and data will be collected at baseline, 6 and 12~     months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life~     with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version~     of the Client Service Receipt Inventory (including lost productivity).~      Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping~     replications will be conducted to asses uncertainty. Cost-acceptability curves will be done~     using two perspectives: the National Health Service perspective and the Societal~     perspective.~      The Propensity Score technique will minimize the absence of randomization, matching cases~     from both treatment options.~   "
62026|NCT02245360|"~     To investigate the immunologic effects and safety of 60-day treatment of the Standardized~     Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass~     pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.~   "
62027|NCT02245347|"~     Drug resistant tuberculosis is a growing problem world wide. The current methods for~     diagnosis are time consuming and may delay diagnosis and treatment for many weeks. In this~     study the investigators wish to take sputum samples from patients to see if the~     investigators can validate a molecular DNA based process for prompt identification of drug~     resistant tuberculosis. The investigators wish to extract and amplify DNA from drug~     resistant tuberculosis and identify genes within it that confer resistance.~   "
62028|NCT02245334|"~     To assess the effect of povidone-iodine on infectious complication rate caused by~     transrectal prostate biopsy~   "
62029|NCT02245321|"~     The prevalence of iron deficiency in blood donors has been demonstrated to be a direct~     consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is~     priority to implement programs to remediate iron deficiency issues associated with blood~     donations. To explore this issue, the study's aims to:~        1. Determine whether regular blood donors provided with accurate information about their~          iron status and written recommended courses of action will take steps to~          prevent/mitigate iron deficiency on their own without being given iron supplements by~          the blood center; and~        2. Determine if two different amounts of iron provided by the blood center will~          prevent/mitigate iron deficiency in regular blood donors.~      To conduct this randomized, placebo controlled study, participant donors will be assigned to~     one of two arms and followed for a 24 month period. Each subject will provide additional~     blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin~     (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.~      Under the two study arms, subjects are to be randomized into one of the following five~     blinded categories:~        -  Receive a thank you letter after each blood donation.~        -  Receive a letter informing them of their ferritin result at each visit, along with~          recommendations for blood donation.~        -  Receive pills to take daily that contain no iron (a placebo or inert pill).~        -  Receive pills to take daily that contain 19 mg of iron (the typical amount in a~          multivitamin with iron).~        -  Receive pills to take daily that contain 38 mg iron (the typical amount in an~          over-the-counter iron supplement).~   "
62030|NCT02245308|"~     The goal of this research study is to examine the effects of a treatment for helping~     homeless veterans who smoke to stop smoking. Participants in the study will be assigned to~     one of two study groups. Participants in the first group will be referred to the local~     Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment.~     Second group participants will receive a behavioral treatment designed to reward smokers for~     quitting and staying quit. These participants will also receive telephone counseling and~     medications for smoking cessation.~   "
62031|NCT02245295|"~     There is a paucity of data concerning the impact of the sedation technique used for~     endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic~     accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA~     in deep and moderate sedation, and to investigate other possible determinants of diagnostic~     accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).~      The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for~     selective sampling in deep sedation are compared with the first consecutive patients in~     moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with~     those on surgical or radiological follow-up.~   "
62032|NCT02245282|"~     Prostate cancer detection and disease progression monitoring relies on systematic multi-core~     biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly~     needed. The purpose of this study is to determine if a new MRI technique can identify~     prostate lesions or to monitor prostate disease progression. If so biopsy core number can be~     reduced to as small as one, and frequency for biopsy repeat can be reduced. The new~     technique is about a new way of analyzing the pictures taken as part of prostate MRI exam.~     This part is called dynamic contrast-enhanced MRI. It involves an injection of contrast~     reagent (or dye) through the arm vein during a time period when prostate MRI pictures are~     continuously taken.~   "
62033|NCT02245269|"~     Study to determine the effects of combined tipranavir and ritonavir treatment (at~     steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of~     single-dose atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects~     of antacid on the pharmacokinetics of tipranavir~   "
62034|NCT02245256|"~     To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative~     delirium in liver transplant patients in the ICU.~      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of~     dexmedetomidine or equivalent amount of saline infusion started after induction of~     anesthesia for liver transplantation and continued until 48 hours after surgery.~      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.~   "
62035|NCT02245243|"~     The purpose of this study is to evaluate the pharmacokinetic profile, safety, and~     tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects~     and subjects with mild, moderate, or severe hepatic impairment.~   "
62036|NCT02245230|"~     The purpose of this study is to better understand the cardiovascular effects of the~     vasodilatory peptide Angiotensin (1-7) in human hypertension. In this study, the~     investigators will test the hypothesis that systemic Angiotensin (1-7) infusion produces~     negligible effects with intact baroreceptors, and that the cardiovascular effects of this~     peptide are unmasked following elimination of baroreflex buffering.~   "
62037|NCT02245217|"~     Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer~   "
62038|NCT02245204|"~     The purpose of this study:~      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics~     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the~     advanced malignant tumor subjects;~   "
62039|NCT02245191|"~     It is a prospective clinical trial with random distribution that intends to investigate~     maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean~     delivery in patients with pre-eclampsia.~   "
62040|NCT02245178|"~     Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the~     United States, but markers that predict risk of developing disease outside of cigarette~     smoking have not been identified. Individuals with lung disease frequently have concurrent~     cardiovascular disease, but the reason for this is not well understood. In this study, we~     will identify markers that predict risk of future lung disease and evaluate the concurrent~     subclinical evolution of lung and heart dysfunction. This will allow for targeting of~     preventive strategies to stop the rising incidence of COPD and other lung diseases and~     provide insights into why heart and lung disease frequently occur together.~   "
62041|NCT02245165|"~     The aim is to elucidate how NO works in conjunction with other neurotransmitters to regulate~     the migrating motility complex (MMC). Twenty-two healthy volunteers should undergo~     water-perfused antroduodenojejunal manometry during a control period of 4 h, followed by~     another 4h after a bolus injection of either saline or the NO synthase inhibitor~     NG-monomethyl-L-arginine (L-NMMA, 10 mg/kg intravenously) with or without atropine (1 mg) or~     ondansetron (8 mg). Effects on the MMC pattern are determined. Exhaled and rectal NO is~     monitored throughout the experiments. Effects of L-NMMA on the MMC pattern are analyzed~     against a background of atropine or ondansetron. Blood samples are drawn for analysis of~     simultaneous peptide hormone release into the bloodstream. Peptide hormone release will be~     correlated to the respective motility pattern elicited by LNMMA.~   "
62042|NCT02245152|"~     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children~     younger than 5 years. 18.7 million children under five years of age suffer from severe acute~     malnutrition (SAM) and an additional 33 million children suffer from moderate acute~     malnutrition, and are at risk of developing SAM~      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute~     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -~     resulting in many missed opportunities for using prevention platforms to screen and refer~     SAM children, or for using screening and referral platforms to provide prevention services.~      This project will address two critical gaps related to the integration of preventive and~     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically~     integrated into routine health-center visits or mainstreamed into community outreach~     programs; and 2) screening programs often do not offer any preventive services for those~     children found not to be suffering from MAM/SAM at the time of screening; mothers of~     children identified as non-MAM/SAM case are usually sent home without receiving any health~     or nutrition inputs and as a result, may fail to come back for screening because they do not~     see any tangible benefit associated with their participation in the screening. This project~     will specifically address these gaps by assessing the effect of an integrated approach~     consisting of higher screening coverage and preventive Behavior Change Communication (BCC) +~     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and~     treatment of child undernutrition.~   "
62043|NCT02245139|"~     Acute gastroenteritis is a common cause of hospital admission and health office visits and~     have a huge burden on the economy of developing countries. The investigators proposed this~     observational prospective study during summer period in a community and tertiary care~     hospital in a rural area of Lebanon to investigate the etiologies and age distribution of~     admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.~   "
62044|NCT02245126|"~     Using routinely collected data to compare different concentrations of locally applied~     anaesthetic drugs and determine which concentrations give better pain control during~     voluntary medical Male circumcision.~   "
62045|NCT02245113|"~     This study will be comparing human body responses by the effects of diets cooked with~     NoveLin, virgin olive oil and RBD coconut oil.~   "
62046|NCT02245100|"~     This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in~     predicting outcomes in patients with stage IV head and neck cancer or stage III-IV non-small~     cell lung cancer. Studying circulating tumor DNA from patients with head and neck or lung~     cancer in the laboratory may help doctors predict how well patients will respond to~     treatment.~   "
62047|NCT02245087|"~     The purpose of this study is to determine whether pharmacologic lowering of low density~     lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can~     eliminate or markedly reduce the composite endpoint of incident all cause mortality,~     myocardial infarction, stroke or coronary revascularization.~   "
62065|NCT02244853|"~     The Cardiovascular disease research using Linked Bespoke studies and Electronic Records~     (CALIBER) e-health database was the data resource for this study. CALIBER links patient~     records from four different data sources: Clinical Practice Research Database (CPRD), MINAP~     (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES),~     the Office for National Statistics (ONS).~   "
62048|NCT02245074|"~     -  Background: Infantile asthma is composed of various phenotypes, however the definition~          is still based on the clinics. Namely, the infants could be classified as transitory,~          peristent or late and persistent asthma. Some risk factors for the persistent asthma~          phenotype are recognized as atopy. However all peristent asthma are not related to~          atopy. Regarding the pathophysiology, little is known on airways inflammation in these~          infants, and the current data are mostly based on the BAL analyses, or on biopsies.~          Consequently, BLA and biopsies should be justified by the need of an indicated~          fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion~          could be also collected after hypertonic saline induction and chest physiotherapy. This~          method has been validated in the children, but has not in the younger.~        -  Aim : Analyses of cell profiles regarding the severity of infantile asthma.~        -  Methods : This descriptive study compared 3 groups of infants, the first with acute~          exacerbation, the second with uncontrolled asthma and the third with controlled asthma.~          Accounting 25% of failure, the number of 40 infants per groups has been calculated. The~          sputum induction will be performed by repeated nebulizations of 3% saline hypertonic~          solution. Cellularity and cell profiles were analysed as previously recommended. Safety~          will be evaluated.~        -  Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of~          wheezing during the 2 first years of life), aged between 6-12months.Asthma control was~          evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was~          aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled~          asthma was defined whether the infant presented any symptoms during the last 4 weeks.~          Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.~        -  Feasibility : A preliminary study has been presented in the Vienna ERS congress.~   "
62049|NCT02245061|"~     The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy~     presurgical assessment frequently requires intracranial recordings like~     stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is~     commonly used during SEEG for functional mapping or to induce seizure.~      However, the recording of seizures is sometimes insufficient to circumscribe the EZ and~     development of new biomarkers is necessary.~      The cortex within the EZ is thought to be hyperexcitable. The paired pulses paradigm,~     using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical~     excitability level. The investigators hypothesize that paired pulses DES during SEEG could~     provide useful information for EZ identification.~   "
62050|NCT02245048|"~     The purpose of this research study is to determine if carotid artery ultrasound scanning can~     provide additional information for determining cardiovascular risk in patients.~      Patients who agree to participate wil undergo non-invasive carotid intima-media thickness~     (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of~     patient standard of care stress echocardiogram (SE) and of diastolic function.~      We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications,~     CIMT and plaque assessment will provide useful risk stratification beyond use of traditional~     risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise~     capacity and 3) Exercise capacity will correlate with diastolic function.~   "
62051|NCT02245035|"~     The purpose of this study is to learn if dairy food consumption may help brain health in~     aging by protecting nerve cells from oxidative damage.~   "
62052|NCT02245022|"~     Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women~      Rationale: In developing countries many women present with a new HIV diagnosis in late~     pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women~     may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in~     previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing~     mother to child transmission of HIV than NNRTI-based regimens.~      Study design: HIV positive pregnant women presenting with untreated HIV infection in late~     (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily)~     or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled~     in third trimester and post-partum.~      Although this is primarily a PK study (and has been powered as such) randomisation is~     included to allow comparison of plasma HIV VL responses against standard of care (NVP or~     EFV) and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in~     pregnancy.~      Number recruited N=30 per group~   "
62053|NCT02245009|"~     Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac~     rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators~     (ICD). External electrical cardioversion is an established method to achieve rhythm control~     (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and~     efficacy of external electrical cardioversion in patients with cardiac rhythm management~     devices exists. Thus, available data on the safety of external electrical cardioversion in~     cardiac rhythm management patients lacks statistical power to accurately reflect the true~     hazard of external electrical cardioversion in patients with cardiac rhythm management~     devices.~      The aim is to systematically include and follow all patients with cardiac rhythm management~     devices presenting for external electrical cardioversion, to analyse the effects of external~     electrical cardioversion on leads and devices.~   "
62054|NCT02244996|"~     Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)~     treatment on retinal functions, especially the cone function, and retinal structure in~     patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial~      Setting: Primary Care clinical trial~      Participants: 120 RP subjects will be recruited from Ophthalmology department at The~     University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly~     allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1~     year. After the 1st year, both groups will stop the treatment and all subjects will also~     have the same eye exam in 6-month period for the 2nd year.~      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4~     programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave~     amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct~     component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS~     visual acuity.~      Results: Lycium barbarum treatment provides the immediate effect and the persistent effect~     on retinal functions and structure in patients with retinitis pigmentosa to improve the cone~     activity. It does not cause any harmful effect to the subjects.~      Conclusion: Cone rescue is an alternative approach to save the vision for RP patients. The~     result of this study will provide valuable information for the treatment of RP. The~     antioxidative effect of LB is believed to delay or minimize the cone degeneration in RP and~     the intake of LB will be a very economic way in the RP treatment.~   "
62116|NCT02244190|"~     To establish the bioequivalence of the new tipranavir oral solution formulation with the~     current tipranavir oral solution formulation following single-dose administration. In each~     case, 500 mg tipranavir was coadministered with 200 mg ritonavir.~   "
62055|NCT02244983|"~     It is the investigators goal to identify the prevalence of underlying diseases, make~     disposition more rational, and establish risk stratification tools in elderly patients~     presenting with falls. Additionally, the outcome of standard care (clinical assessment only~     for disposition) will be compared with a new approach combining the standard of care with~     biomarker assisted disposition of elderly patients presenting with falls. Therefore the~     investigators are looking at the following points.~      Emergency department work-up~        1. Prevalence of underlying disease~        2. Developing algorithms for initial assessment Disposition~      a. Establishing biomarker enhanced disposition planning by using risk-stratification tools~     b. Comparing geriatric emergency assessment to standardized disposition planning~   "
62056|NCT02244970|"~     Depressive mood and anxiety are prevalent in patients suffering from early psychosis.~     Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed~     Mindfulness-based intervention (MBI) as an effective option in handling depression and~     anxiety. There is a great possibility that MBI is also useful in depression and anxiety~     associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong~     Kong or any other countries, a brief intervention is more favored. Current paper is a study~     protocol for a randomized controlled trial which assess the feasibility of a 7-week~     mindfulness-based intervention in patients with early psychosis targeting on their~     depressive mood and anxiety.~      In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and~     mild depressive mood or anxiety will be invited to join this single blind randomized~     controlled trial. After baseline assessments, eligible participants will be, using third~     party simple randomization, randomly assigned to either the 7-week Mindfulness-based~     Intervention (MBI), or the psychoeducation group as control.~      The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months.~     The secondary outcomes include life functioning, quality of life, other general clinical~     symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the~     feasibility of the intervention. Data will be analyzed according to the intention-to-treat~     principle.~      This randomized trial offers an insight into mindfulness-based intervention and its~     effectiveness on psychosis concomitants. It provides the foundation for future evaluation~     and implementation of an effective and cost-efficient treatment option.~   "
62057|NCT02244957|"~     The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea~     (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.~     population.The investigators propose to conduct this study that aims: (1) to compare right~     and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI)~     in overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level~     positive airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)~     hemodynamics in overlap syndrome.~      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have~     more RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia~     and hypercapnia during sleep will improve RV hemodynamics compared with treatment of~     hypoxemia alone in patients with overlap syndrome.~   "
62058|NCT02244944|"~     The purpose of this research is to gather information on the combination Zetia® (Ezetimibe)~     and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver~     function in subjects with nonalcoholic fatty liver disease (NAFLD).~   "
62059|NCT02244931|"~     The purpose of this study is to compare three assisting devices to propel personal~     wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual~     wheelchair in patients with spinal cord injury.~   "
62060|NCT02244918|"~     The researchers are testing if counseling alone or counseling plus over-the-counter nicotine~     replacement therapies (NRT), like the patch,gum, or lozenge, helps African American~     non-daily smokers quit smoking.~   "
62061|NCT02244905|"~     Healthcare-associated infections (HAI) are a significant public health burden. Even with~     existence of recommendations on technical strategies to prevent these infections, there is a~     need for strategies to increase staff engagement within the local organizational and~     cultural context. Positive deviance is one such approach that engages people in improvement~     efforts. Positive Deviance is based on the observation that in every community there are~     certain individuals or groups whose uncommon behaviors and strategies enable them to find~     better solutions to problems than their peers, while having access to the same resources and~     facing similar or worse challenges. In the proposed study, the investigators plan to test~     the effectiveness of using positive deviance based horizontal infection prevention approach~     to achieve overall reduction of HAIs among hospital inpatients. The investigators~     hypothesized that a broad and horizontal approach to reduce opportunities for acquisition of~     nosocomial pathogens using PD will lead to greater reduction of HAI among hospital~     inpatients compared to standard-of-care infection control approach. The investigators~     objective was to test the investigators hypothesis and evaluate whether there is greater~     decline in rate of HAI in the experimental group of wards compared to the control group of~     wards.~   "
62062|NCT02244892|"~     Disability glare is described as halos or starbursts around bright sources of light that~     can cause discomfort and reduce vision. The cornea is the clear window at the front of the~     eye, but certain conditions such as a previous infection can leave a scar. Corneal scars can~     cause disability glare by scattering and spreading incoming light instead of allowing it to~     focus on the back of the eye (retina) to get a crisp image. In this study, the corneal scar~     will be analyzed using a new device that measures scar density (Pentacam), and a~     relationship with disability glare will be made. This can help us further understand~     disability glare and make better decisions in the future on when to treat these scars to~     help patients see better.~   "
62063|NCT02244879|"~     This research will investigate the effect of resveratrol on inflammatory mediators in type 2~     diabetic patients in vivo.~      The investigators will also investigate the hypothesis that resveratrol has an antioxidant~     activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.~   "
62064|NCT02244866|"~     To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation~     (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.~      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH~     supplementation) for ovarian stimulation in aged IVF patients.~   "
62153|NCT02243709|"~     The goal of this study is to determine if, under stress, alcohol drinking is reduced using~     mifepristone~   "
62066|NCT02244840|"~     Sitz bath is conventional and empirical remedy and commonly recommended for non-operative~     treatment of various anal diseases. However, as there was no substitute for sitz bath until~     now, the patients have to accept the inconvenience for treatment of their diseases.~      Electronic bidet is used with convenience as automatic device for cleansing the perineal~     area, especially after defecation. The similarity of contacting water to perineal area,~     clinical use of electronic bidet has been suggested for treatment of anal diseases. However,~     there had been few reports of clinical use of electronic bidet.~      Investigators performed the study to evaluate the effects of electronic bidet on anal~     resting pressure, compared to conventional warm sitz bath in normal healthy volunteers.~   "
62067|NCT02244827|"~     This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate~     metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment~     and healthy volunteers.~   "
62068|NCT02244814|"~     The rapidly rising risk of gestational diabetes pregnant women demands that an effective~     diet strategy be developed due to the high risk of fetal overgrowth, which places the~     newborn at increased risk for childhood obesity and metabolic syndrome. The aims of this~     randomized clinical trial are to compare the effects of an 8-wk isocaloric higher complex~     carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on~     glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters,~     the maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary~     outcome). The investigators will then follow the infants for 1-yr and measure maternal~     breast milk and infant microbiome composition to observe if they impact net fat mass gain~     differently in infants exposed to one diet vs. the other. Identifying a diet for gestational~     diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to~     reducing short- and long-term metabolic risk in this growing cohort of mothers and infants~     and has the potential to be applicable to overweight/obese pregnant women.~   "
62069|NCT02244801|"~     This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for~     adult, de novo, living donor renal transplant recipients.~   "
62070|NCT02244788|"~     The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal~     Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a~     requirement by the FDA for humanitarian use of device~   "
62071|NCT02244775|"~     The purpose of this study is to allow patients to undergo surgery with the SR™ MCP~     (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but~     rather, a requirement by the FDA for humanitarian use of device.~   "
62072|NCT02244762|"~     Determine the influence of renal impairment on the pharmacokinetics and metabolism of~     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules~   "
62073|NCT02244749|"~     The researcher can proved that certain compounds play an important role in the prevention of~     skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes,~     and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies~     of normal skin and precancerous or cancerous lesions, and can compare the concentrations of~     these compounds to determine the difference between the two areas. The result can lead to~     further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers~     are so common, any knowledge would be very useful for many people in the future and may be~     used for development of future treatments or prevention strategies.~   "
62074|NCT02244736|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. The association between damage of endothelial glycocalyx,~     impaired arterial elastic properties, and CFR in diabetics and first degree relatives has~     not been explored. The purpose of this study is to explore the association between damage of~     endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and~     first-degree relatives before and after during oral glucose tolerance test (OGTT).~   "
62075|NCT02244723|"~     Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by~     mechanically-ventilated patients in the intensive care unit (ICU). It has significant~     clinical and economic consequences, as it is associated with considerable morbidity,~     increased mortality, and excess health care costs. Appropriate antibiotic therapy for~     patients with VAP significantly improves outcomes, making rapid identification of patients~     with VAP an important clinical goal.~      This application is for support of a prospective, multi-centered study to evaluate the~     diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association~     of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could~     allow for early and reliable diagnosis of bacterial VAP.~      Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung~     ultrasound alone and in association with the CPIS.~      Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural~     consolidation, irregular B-lines) in VAP.~      Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung~     ultrasound, and unprotected tracheal aspirate (UTA).~   "
62076|NCT02244710|"~     Randomized clinical trial to assess the influence of treatment with ticagrelor or~     clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial~     Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to~     chronic levels (1 month).~   "
62077|NCT02244697|"~     Stridor is a respiratory noise caused by partial obstruction of the large airways at the~     level of the pharynx, larynx and/or trachea. The second most common cause of stridor is~     vocal cord paralysis.~      Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of~     laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient~     and the laryngeal view may be obscured due to patient movement or anatomical variations.~      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging~     technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect~     reliability in comparison to nasolryngoscopy suggesting that US can be useful in the~     assessment of laryngeal adduction.~      The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in~     the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric~     population.~   "
62154|NCT02243696|"~     The purpose of this registry study is to confirm the long-term safety and reliability of the~     Protego DF4 right ventricular lead.~   "
62078|NCT02244684|"~     An overwhelming body of evidence of the protective effect of folic acid supplementation on~     neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada~     in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in~     DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated~     in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming~     occurs in utero and has the potential to be modulated by the methyl donor supply of which~     folate is a contributor. Animal studies have shown maternal folate exposure can modulate~     epigenetic changes in the offspring, however, there is limited evidence of this relationship~     in humans. The aim of this research is to determine the effects of maternal dietary folate~     and supplemental folic acid intake during the periconceptional and in utero periods on~     global and gene-specific DNA methylation in human infants. This is a prospective~     observational study involving 368 Canadian mother-child pairs recruited from St. Michael's~     Hospital in Toronto, Ontario. Dietary and demographical information was collected from~     consenting pregnant women at study baseline (12-16 weeks gestation) and in the third~     trimester (34-37 weeks gestation). Maternal blood samples were obtained at baseline and~     prior to delivery and a sample of umbilical cord blood was collected at parturition to~     measure levels of folate status. Global and gene-specific DNA methylation in umbilical cord~     blood will be correlated with cord and maternal folate status. The data will be analyzed~     using separate ordinary least squares (OLS) regressions. Results from this study will~     contribute to a better understanding of how maternal folate and folic acid intake can~     modulate epigenetic modifications in the offspring and potentially have an effect on disease~     susceptibility later in life.~   "
62079|NCT02244671|"~     immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with~     platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital~     fat~   "
62080|NCT02244658|"~     Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe~     thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at~     evaluating efficacy and safety of rhTPO in management of chemotherapy-induced~     thrombocytopenia in acute myelocytic leukemia.~   "
62081|NCT02244645|"~     This study may clarify a potential promising mechanism and clearest evidence to support the~     value of yoga as a therapeutic option for reducing chronic low back pain.~   "
62082|NCT02244632|"~     The purpose is to characterise the tolerability of Modufolin in combination with 5-FU alone,~     in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in~     combination with 5-FU, Oxaliplatin and Bevacizumab.~      Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further~     assessment.~   "
62083|NCT02244619|"~     The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip~     or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV~     acetaminophen~   "
62084|NCT02244606|"~     The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral~     SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the~     treatment of invasive candidiasis.~   "
62085|NCT02244593|"~     Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for~     detecting breast cancer however, MRI is not always reliable because it can indicate the~     presence of cancer when in reality, there is none; this is called a 'false positive' result.~     A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with~     breast MRI. This study is being done to assess a new technique called FAST breast MRI. A~     FAST breast MRI is different than a traditional breast MRI because it has much fewer~     sequences and takes approximately 3 minutes for the scan. MRI sequences are combinations of~     magnetic pulses that collect information about the tissues. There is no radiation associated~     with an MRI.~      The purpose of this study is to determine the impact on patient health when a FAST breast~     MRI is used as a screening technique in women with a personal history of cancer. It has been~     shown that FAST breast MRI is similar to routine breast MRI in the detection of breast~     cancer, but it has not been proven that FAST breast MRI will help women who have a personal~     history for breast cancer. Currently, routine breast MRI is not part of the standard of care~     in screening for breast cancer in women who have a prior personal history of breast cancer.~     By evaluating FAST MRI the investigators are able to study the effects of this short MRI on~     cancer detection in women with a personal history of breast cancer, and on the impact on~     overall health. The investigators estimate that 300 participants will be enrolled in the~     study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the~     Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants~     have had a history of breast carcinoma.~   "
62086|NCT02244580|"~     This is a prospective examination of tumor material of breast cancer patients randomized~     into the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as~     adjuvant treatments of breast cancer patients wirh a high risk of cancer recurrence).~      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor~     1 (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and~     Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.~      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall~     survival (OS) will be re-evaluated.~   "
62087|NCT02244567|"~     High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired~     insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women~     trying to interfere with the pathophysiology of PCOS in these women as followed up by serum~     UC-OC levels.~   "
62088|NCT02244554|"~     The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal~     with picosecond pulse durations as compared to treatment with nanosecond pulse durations~     using a single novel Q-Switched (QS) Nd:YAG laser.~   "
62089|NCT02244541|"~     The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of~     ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary~     objectives being to explore the relationship between dosing regimen and pharmacodynamics~     efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore~     the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.~   "
62090|NCT02244528|"~     The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used~     as treatment of pulmonary hypertension in neonate and preterm infant.~   "
62091|NCT02244515|"~     The purpose of this study is to determine whether dexmedetomidine is effective in the~     treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral~     palsy.~   "
62155|NCT02243683|"~     The purpose of this study is to determine the toxicity, tolerability and safety of single~     ascending doses of AX-024.HCl in healthy male subjects.~   "
90549|NCT01872013|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after multiple oral administrations to non-elderly subjects.~   "
62092|NCT02244502|"~     The study is a prospective, single arm, non-randomized, open label pilot trial, designed to~     study the safety, toxicity, feasibility and preliminary efficacy of a medical device, the~     NovoTTF-100L(O) concomitant with weekly paclitaxel in recurrent ovarian carcinoma patients.~     The device is an experimental, portable, battery operated device for chronic administration~     of alternating electric fields (termed TTFields or TTF) to the region of the malignant~     tumor, by means of surface, insulated electrode arrays.~   "
62093|NCT02244489|"~     This study will evaluate the safety, tolerability, and define the maximum tolerated dose~     (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with~     relapsed/refractory metastatic pancreatic ductal adenocarcinoma.~   "
62094|NCT02244476|"~     Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon~     consumption, food industry strives to reduce these ingredients while maintaining the taste,~     texture and aroma properties of the beverages. A successful reduction of fat and sugar from~     drinks has still proven a great challenge since consumers have less preference for the mouth~     feel of reformulated beverages than for the regular beverages. Mainly because instrumental~     measures like rheology and traditional tribology do not entirely predict the experienced~     mouth feel, there is an interest in alternative correlates for mouth feel aspects related to~     fat and sugar perception. In a recent study it was demonstrated that vibrations produced~     during interaction between the tongue, palate and beverages during consumption are very~     sensitive to the amount of fat and texturizers in the beverage. The present study aims at~     clarifying that relation for a larger panel of human subjects, by systematically evaluating~     vibration spectra during consumption of dairy beverages that differ in fat content, sugar~     content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with~     mouth feel-related sensory properties and composition of fat deposits on the tongue will be~     assessed.~   "
62095|NCT02244463|"~     This research study is studying a targeted therapy (ML0N128) as a possible treatment for~     anaplastic thyroid cancer.~      This research study is a Phase II clinical trial. Phase II clinical trials test the safety~     and effectiveness of an investigational intervention to learn whether the intervention works~     in treating a specific disease. Investigational means that the intervention is being~     studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a~     treatment for any disease.~      MLN0128 prevents tumor cells from dividing and growing by selectively and potently~     inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with~     anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their~     tumor cells which may make the cancer more sensitive to inhibition by MLN0128.~      In this research study,the investigators are investigating usefulness of MLN0128 in~     metastatic anaplastic thyroid cancer cases.~   "
62096|NCT02244450|"~     Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune~     system by characterised profound abnormalities of T cell development . Infants with SCID~     require prompt clinical response to Prevent life -threatening infection and studies show~     significantly improved survival in babies Diagnosed at birth as a result of previous family~     history . SCID follows criteria for population -based newborn screening since it is~     asymptomatic at birth and fatal within the first year of life, the confirmation of the~     disease is easy, there is a curative treatment , and it is known that early stem cell~     transplantation improves survival . Quantification of TRECs (T- cell receptor excision~     circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific~     and SCID .~      The investigators propose in this study to perform a neonatal screening of SCID , in a~     population of 200,000 babies over a period of two years .~      The investigators propose to study the clinical utility and cost effectiveness ratio, and~     SCID screening to demonstrate that could result in a broad benefit to Individuals detected ,~     making screening relatively cost-effective in spite of the low incidence of the disease .~   "
62097|NCT02244437|"~     AMS (acute mountain sickness) affects those who ascend too high (>2000m) too fast.~     Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization~     with gradual ascent may not be an option. AMS presents with headache and other non-specific~     symptoms such as nausea, tiredness, and dizziness. Because of the side effects of~     acetazolamide such as a tingling sensation, other drugs have been investigated to see if~     they will prevent AMS. Ibuprofen has recently been shown to prevent AMS. In this present~     study the investigators want to see if acetaminophen can also prevent AMS as acetaminophen~     unlike ibuprofen does not have gastric side effects. Second, because acetaminophen has much~     less anti-inflammatory component than ibuprofen, it may also provide some insight into the~     pathophysiology of AMS if acetaminophen were found to be effective in the prevention of AMS.~   "
62098|NCT02244424|"~     The purpose of this social media group randomized trial (GRT) is to test the feasibility of~     our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues~     and implement healthy feeding practices through development of a healthy feeding style.~      Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered~     to the target population as it relates to their acceptance and satisfaction with the~     content, format, delivery, and use of social media.~      Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of~     infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and~     feeding practices evaluated at the completion of the intervention using self-report methods.~   "
62099|NCT02244411|"~     The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic~     leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and~     exercise can help people lose weight and improve other health problems. This two year study~     will compare two methods of informing participants about ways to lose weight.~   "
62100|NCT02244398|"~     The purpose of this study is to evaluate the feasibility and acceptability of adding HIV~     testing and counseling (HTC) services to the family planning (FP) services provided by~     community health workers in Uganda.~   "
62177|NCT02243397|"~     The purpose of the study is to investigate the different types and subtypes of cells found~     in breast tumors. The investigators will do this using a variety of molecular analysis tools~     that may allow for improved tests. The different types of cells in breast cancer impacts the~     way individuals respond to various treatments.~   "
69509|NCT02147535|"~     The purpose of this study is to determine whether differences in the gene coding for the~     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of~     methylphenidate, a CES1 dependent drug.~   "
62101|NCT02244385|"~     25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity)~     will develop pre-eclampsia and or growth restriction. In addition, the frequency of~     stillbirths in this group is dramatically increased over the general population. Pregnancy~     complications in this very heterogeneous group are likely to be a combination of a failure~     of the maternal vasculature to adapt to pregnancy and/or a failure of placental development.~     The relative contribution of these two mechanisms is poorly understood and current~     preventative strategies (aspirin) in this group only prevent a small number of adverse~     outcomes. This important and complex group have been inadequately investigated to date~     mainly because of the diversity of their underlying disease complicating prospective~     research studies.~      The evolution of tools which allow more detailed assessments of both uteroplacental blood~     flow and maternal vascular function will enable us to perform prospective studies in these~     women and to develop targeted preventative measures. Recent biomarker studies have also~     identified a number of biomarkers which have not yet been assessed in these high risk~     groups.~   "
62102|NCT02244372|"~     The investigators performed randomized, double-blind, placebo-controlled human trial to~     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract~     (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured~     promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12,~     IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)~   "
62103|NCT02244359|"~     One of the toughest decisions faced by the frail elderly in Canada is whether to stay at~     home or move to a care facility. It is certainly difficult to make this decision alone, but~     can be even harder if someone else makes it for you. Shared decision making is when, instead~     of making decisions for the patient, healthcare professionals share information about what~     the evidence says, and they talk about what's important with the patient, and then make the~     decision together. In the case of the frail elderly in home care services, there are many~     health care professionals involved, e.g. the doctor, nurse and social worker. In this case~     decisions should be shared by all the professionals involved with the elderly person along~     with his or her caregivers. Unfortunately, in this context, shared decision making rarely~     occurs.~      We have designed a training program that teaches interprofessional teams how to share~     decisions with their frail elderly patients, and tested it in one Quebec City and one~     Edmonton home care team. This project tests the training program on a broader scale with 16~     home care teams attached to community health centres across the province of Quebec, and will~     compare the results with what happens when no one has completed the training (usual care).~     Home care is a rapidly growing sector and this study will lay the foundations for a national~     strategy to ensure that no one has to make this difficult decision alone.~   "
62104|NCT02244346|"~     Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of~     Benign Prostatic Hyperplasia in real clinical practice~   "
62105|NCT02244333|"~     Study to assess efficacy, tolerability and safety parameters of a one month ALNA® -~     treatment after switch from Terazosin-treatment~   "
62106|NCT02244320|"~     The objective of the observational study were to investigate the switch from phytotherapy to~     ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of~     ≥ 8 points (International Prostate Symptom Score (IPSS))~   "
62107|NCT02244307|"~     The primary objective of this observational study was the assessment of prognosis factors~     for having recourse to prostatic surgery in patients with BPH who were administered class-1~     alpha blockers. The secondary objectives were the assessment of the time from~     alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients~     during the study.~   "
62108|NCT02244294|"~     To establish whether the administration of FLOMAX® improves the outcome of a trial without~     catheter (TWOC) after an episode of acute urinary retention and to determine whether~     spontaneous voiding is maintained over the course of six months of active treatment~   "
62109|NCT02244281|"~     1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily~          compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a~          significant component of voiding symptoms~        2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient~          population, in quality of life~        3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo,~          in women suffering from LUTS with a significant component of voiding symptoms~   "
62110|NCT02244268|"~     The aims of this observational study are to identify the primary BPH symptoms responsible~     for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to~     assess the clincial efficacy on an improved occupational performance of the patients being~     still employed. Additionally to obtain relevant information for the 5-year report of~     experience with this product according to the requirements in § 49, para 6 of the German~     Medicines Act.~   "
62111|NCT02244255|"~     1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg~          daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the~          signs and symptoms of benign prostatic hyperplasia (BPH)~        2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in~          comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the~          symptoms of benign prostatic hyperplasia~   "
62112|NCT02244242|"~     Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in~     patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to~     provide primary care physicians experience with the use of tamsulosin hydrochloride capsules~     0.4 mg daily for the treatment of BPH~   "
62113|NCT02244229|"~     Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH~     patients, two medications indicated in BPH belonging to two different pharmacological~     classes, as evaluated from the point of view of patient's perception of his pathological~     condition and of the impact of the disease on general health and quality of life~   "
62114|NCT02244216|"~     Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec®~     200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler~   "
62115|NCT02244203|"~     Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics~     and pharmacodynamics of BI 60732~   "
62117|NCT02244177|"~     Numbers of postoperative PCA related side effects among three groups will be determined by~     comparing and analyzing frequency distributions. To determine whether the patients with~     hypertension require less post operative opiate analgesics than others, multivariate~     analysis with repeated measures will be performed to identify the major and the minor~     factors predicting the use of postoperative pain therapy. The major aim of the study is to~     test the hypothesis that the morphine comsumpted by the hypertension group is less than~     those of the normotension group. The minor aims for the study are the difference related to~     pain intensity, or the incidence of side effects among groups.~   "
62118|NCT02244164|"~     Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for~     diabetes. Previous retrospective studies have shown that these treatments induced an~     increase in pancreatic mass with potentially a risk for pancreatitis and development of~     precancerous lesions.~      The aim of our study is to provide a better understanding of the pathophysiological~     mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to~     certain treatment of type 2 diabetes.~   "
62119|NCT02244151|"~     The aim of this study is to determine what is the best time interval between GnRH agonist~     (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes~     (MII) collected in IVF cycles.~   "
62120|NCT02244138|"~     Preventive care for adolescents is vitally important for maximizing their health and~     well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive~     needs of adolescents as demonstrated by poor health outcomes for this population.~      In this grant application, the investigators propose to expand an existing computer decision~     support system (CDSS) into the investigators adolescent primary care practices for the~     purpose of implementing a comprehensive, and developmentally appropriate, screening and~     physician decision support process. Prior work completed by the investigators research group~     has demonstrated the feasibility of using CDSS to implement and evaluate clinical~     guidelines. The investigators seek to positively impact the effectiveness of preventative~     primary care visits by applying this previous success to the investigators adolescent~     practice. The investigators hypothesize that the implementation of developmentally~     appropriate universal screening practices, using tablet technology, and enhanced physician~     decision support regarding clinically relevant guidelines for all annual adolescent~     preventive care visits will result in better health outcomes, including higher rates of~     adherence to physician recommendations and improved patient functioning.~      The specific research aims of this proposal are:~      Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module~     comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years~     and tailored evidence-based clinical decision support for physicians.~      Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of~     specific mental and physical health problems and treatment outcomes in an adolescent primary~     health care setting.~      Adolescent primary care issues of interest for this project include sexually transmitted~     infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The~     investigators expect this project to improve the health outcomes of adolescents, guide~     future efforts to implement universal screening and CDSS in a variety of primary care~     settings, and provide additional evidence to support broad-based electronic screening and~     computerized decision support for use in preventive care as a method for improving~     adolescent health.~   "
62121|NCT02244125|"~     Imnovid in combination with dexamethasone is indicated in the treatment of adult patients~     with relapsed and refractory multiple myeloma who have received at least two prior treatment~     regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have~     demonstrated disease progression on the last therapy.~      Patients with relapsed and refractory multiple myeloma who have received bortezomib,~     lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal~     treatment, can access to pomalidomide under marketing authorization only as from third line~     of treatment.~      In France this combination is not authorized for marketing for a first line treatment and~     only patient randomized in the IFM/DFCI 2009 trial received it.~      This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have~     received bortezomib, lenalidomide and Dexamethasone combination in first line, which at~     progression/relapse time therapeutic opportunities remained limited and who cannot access~     pomalidomide under marketing authorization.~      This study is a multicentre, phase 2, open label, study testing the triple combination of~     pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who~     are refractory or in first progression/relapse after a first line treatment with bortezomib~     and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according~     to the IFM/DFCI 2009 trial.~      In the IFM/DFCI trial, patients in arm A received eight cycles of the~     Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance,~     patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus~     melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of~     Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide~     maintenance.~      This study will contain 3 treatment phases:~        -  Study treatment phase:~      All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone~     combination.~        -  Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):~             -  For patients previously randomized in IFM/DFCI 2009's arm A:~                  -  Melphalan 200 mg/m2 followed by Autologous Transplantation~                  -  Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone~                    combination~             -  For patients previously randomized in IFM/DFCI 2009's arm B:~                  -  5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination~        -  Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and~          Dexamethasone until progression / relapse or discontinuation for any other reason.~      For arm B patients, in case relapse occurs at least 12 months after the end of the~     maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation~     and therefore follow the arm A procedure. The decision to proceed to a second transplant~     will be made by the physician and the patient.~      In order to have the same amount of patients enrolled in this trial in the initial Arm A and~     Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B,~     subsequent patients will be eligible if they have not been initially treated as the first 50~     patients from either arm.~      The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles~     of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the~     studied population using International Myeloma Working Group (IMWG) response criteria.~   "
62122|NCT02244112|"~     The purpose of this Phase 1 of the study is to evaluate the effect of food on the~     pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam,~     and the safety and tolerability of oprozomib in patients with advanced malignancies~   "
62123|NCT02244099|"~     The purpose of this study is to characterize and improve controlled substance, carisoprodol~     and tramadol use in an internal medicine residents' clinic. Specific objectives of this~     study include:~        -  To measure the adherence to a controlled substance treatment agreement (CSTA) before~          and after implementation of a population management intervention~        -  To determine the number of patients on a CSTA with a discrepancy identified on a urine~          drug screen or an Ohio Automated Rx Reporting System (OARRS) report~        -  To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day~          before and after implementation of a review intervention~        -  To characterize the healthcare utilization of patients taking controlled substances,~          carisoprodol, or tramadol by tracking the mean number of ED visits, hospital~          admissions, telephone calls, and clinic office visits during a 6 month period~   "
62124|NCT02244086|"~     Abstract.~      Epidural analgesia is the most safe and effective for the treatment of pain of childbirth~     method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most~     widely used local anesthetic in obstetric anesthesia.~      Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women~     in labor.~      Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into~     two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group~     B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B~     received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure,~     heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at~     different periods of time.~      Results: Demographic characteristics and parity were compared, no statistically significant~     differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into~     statistically significant differences in favor of the group with 0.25% Bupivacaine with~     decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial~     pressure, heart rate and respiratory rate were found between the two groups.~      Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared~     with 0.125% bupivacaine.~   "
62125|NCT02244073|"~     During the last 2 decades, the management of hyperglycemia in critically ill patients has~     become one of the most discussed topics in the intensive-care field. The initial data~     suggesting significant benefit from the normalization of blood glucose levels in critically~     ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J~     Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some~     studies suggested that strict blood glucose control might benefit in non-diabetic patient~     and worsen outcomes in diabetics. We hypothesized that an individualized blood glucose~     target based on glycated hemoglobin measured at ICU admission would improve outcome when~     compared to a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We~     designed a randomized double blinded study in which Blood glucose control is piloted in both~     groups by a web-guided protocol that directly gives instruction to nurses~     (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.~     Primary end point is 90 d outcome after randomization.~   "
62126|NCT02244060|"~     Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued~     to be subjective and not comparable. A middle ground approach is to apply the frontier work~     of vignette methods. The aim of the survey experiment is to explore the validity of survey~     instruments to identify students who need glasses, using objectively measured visual acuity~     as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is~     significantly different from indirect comparison against vignette (ICV); meanwhile,~     self-assessment of vision (SAV) is significantly different from primed self-assessment of~     vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV~     to classify students who need glasses, using objective visual acuity as a gold standard.~     Lastly, it is hypothesized that priming effect from vignettes improves the validity of~     self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.~   "
62127|NCT02244047|"~     Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption~     of gluten and related prolamines in genetically susceptible individuals. Not only genetic~     but also environmental factors play an important role in CD pathogenesis. CD patients have~     imbalance in the gut microbiota, they have reduced number of Bididobacterium species in~     feces and biopsies.~      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If~     gluten free diet is not strict that leads over the years to complications of disease, such~     as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by~     continuous recirculation of activated immune cells between the inflamed organ and the~     periphery. To avoid complications of disease in long term the investigators want to test~     specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies~     recognized as anti-inflammatory.~      Hypothesis~        1. Children with celiac disease on gluten free diet have a higher level of~          pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in~          comparison with healthy controls.~        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level~          increase.~      In the investigators research will be selected 70 children, age from 2 to 18 years, divided~     in different groups:~        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive~          probiotic for 3 months.~        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive~          placebo for 3 months.~        3. Group: 20 healthy children~   "
62128|NCT02244034|"~     Background: Postoperative hypothermia may result in relevant complications such as adverse~     cardiovascular events, wound infection, and coagulopathy with consecutive blood loss.~     Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for~     hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158~     patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the~     first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface~     including wound surface are exposed. Many of these patients receive large amounts of~     infusions and transfusions, and undergo hemodilution during CPB, which may additionally~     contribute to development of hypothermia.~      Objective of the planned study is to find out incidence and duration of postoperative~     hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is~     the incidence of postoperative complications and its relation to postoperative core~     temperature.~      Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery~     with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative~     hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).~      The following parameters will be recorded: temperature is measured at ICU after arrived and~     after 6 hours which is primary outcome, biometric data include age, sex, body weight,~     height, ASA physical status, surgical procedure includes emergency cases, anesthetic and~     surgical (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest~     temperature during bypass, method of temperature protection, and the outcome of operation .~      All data will be described in number and percent and Pearson chi-square method will be used~     for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined~     to significant.~   "
62129|NCT02244021|"~     A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in~     relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.~   "
62130|NCT02244008|"~     The purpose of this study is to verify the effect of anteroposterior talus mobilization on~     range of motion, pain, and functional capacity in participants with sub-acute and chronic~     ankle injuries.~   "
62131|NCT02243995|"~     Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent~     problems in sarcoidosis. These physical impairments are disabling and affect quality of life~     in a negative way. The aetiology of these physical impairments is multifactorial. Physical~     inactivity can cause deconditioning, resulting in more perceived fatigue and muscle~     weakness. These symptoms may be partially reversible following a structured physical~     training program. However, scientific studies about physical training in sarcoidosis are~     lacking. Therefore, the aim of the present study is to examine the changes in fatigue~     complaints, physical functioning and quality of life (QOL) in patients with sarcoidosis~     following a 13-week physical training program.~      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical~     training program for three times a week. This training program includes peripheral muscle~     training for both the upper and lower extremities (starting at 40% of the~     multiple-repetition maximum) and endurance training consisting of walking on a treadmill~     (starting at 60% of the speed of the 6-minute walk test) or cycling on a ergometer (starting~     at 50% of the Wmax).~      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after~     ending the training. During these assessments, patients perform muscle strength (m.~     quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance~     cycling test). They also complete several questionnaires:~      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment~     instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical~     Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression~     Scale (HADS)~   "
62132|NCT02243982|"~     The PET tracer Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile ([F18]-FDDNP) has~     a specific affinity for lesions containing tau protein and beta-amyloid The study consists~     of two phases~        -  In a first transversal phase, 8 neurologically unimpaired controls, 15 patients with PD~          and no dementia (PDND) and 8 with PD and dementia (PDD) will undergo lumbar puncture~          for study of tau, phospho-tau and beta-amyloid levels in cerebrospinal fluid (CSF), as~          well as positron emission tomography (PET) with ([F18]-FDDNP. Concentration of CSF~          markers and both the degree and topography of FDDNP-PET uptake will be compared among~          groups, along with correlation analysis between CSF and PET findings.~        -  During the second phase (18 months follow-up), the PDND patients will undergo the same~          procedures, and cognitive changes including incident dementia will be assessed. The~          correlation between cognitive impairment and neurochemical and neuroimaging changes~          will be established to determine the predictive value of these markers.~      Since the pathological lesions observed in Alzheimer disease (AD) are common in the PD and~     the concentrations of tau and beta-amyloid are altered in AD and PET with [F18]-FDDNP is~     able to separate patients with AD and cognitive impairment from controls, we hypothesized~     that:~        1. - Patients with PD will show a biomarkers profile similar to the AD (decreased levels~          of beta-amyloid and increased phospho-tau and tau) in CSF, and an abnormal uptake of~          [F18]-FDDNP PET compared to PDND patients and controls.~        2. -The distribution of cortical [F18]-FDDNP in the PD will be different from the AD and~          similar to dementia with Lewy bodies, predominantly in posterior cortical areas.~        3. PDND patients will show a [F18]-FDDNP PET uptake and levels of protein markers in CSF~          intermediate between controls and patients with PD.~        4. -In the subsequent follow-up, PDND patients will show cognitive impairment correlate to~          changes in the levels of protein markers in CSF and uptake of PET with [F18]-FDDNP~        5. - The predictive value for the development of dementia in PD of specific patterns of~          PET uptake and CSF proteins profile will be established.~   "
62133|NCT02243969|"~     Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic~     acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for~     the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most~     common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also~     have a protective effect on the development on cardiovascular disease, but may exert its~     cardio protective effects through different routes. The benefit may (partly) be due to blood~     pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is~     conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA,~     using a study powered on 24-hour blood pressure, in a population with high normal blood~     pressure and mild hypertension.~      Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial~     pressure (MAP) in men and women with high-normal blood pressure and mild hypertension~     compared to high oleic sunflower oil, poor in ALA.~      Study design: Using a double blind randomized, placebo-controlled parallel design, subjects~     will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF)~     as control for twelve weeks, with a run-in period of 14 days in advance.~      Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood~     pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will~     participate in the run-in and intervention period. It is estimated that 144 subject have to~     be screened to find 72 subjects that will enter the run-in period.~      Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein~     oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil.~     All oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one~     at dinner.~      Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory~     mean arterial pressure (MAP)~   "
62134|NCT02243956|"~     The purpose of this study is to investigate effects of a selected food product rich in~     polyphenol on cognitive performance and mood.~   "
62135|NCT02243943|"~     Suboptimal reversal of neuromuscular blockage after surgery is possibly related to~     unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and~     complete reversal of neuromuscular block was not possible untill sugammadex was discovered.~     The investigators hyposthesise that reversal with sugammadex leads to favorable~     postoperative respiratory conditions and less pain compared to reversal with neostigmine.~   "
62136|NCT02243930|"~     The purpose of this study is to investigate the attachment of a transparent hood (cap) on~     the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce~     investigation time, and increases the success rate of the sigmoidoscopy. The study focus on~     the less-experienced endoscopist.~   "
62137|NCT02243917|"~     This is a multicenter, open-label, Phase 1 study of orally administered CB-5083 in adult~     subjects with advanced metastatic solid tumors. The study will be conducted in 2 parts: an~     initial Dose Escalation Phase (Phase 1a) of CB-5083 in subjects with advanced metastatic~     solid tumors who have progressed or are non-responsive to available therapies and for which~     no standard therapy exists, followed by a Dose Expansion Phase (Phase 1b) which will include~     1 to 4 arms: one arm in subjects with RAS mutated mCRC; optionally, at sponsors discretion,~     3 additional arms may be added for subjects with advanced RCC, advanced pNET, or solid~     tumors with mutations in the RAS-MAPK pathway.~   "
62138|NCT02243904|"~     Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up~     study of lead workers with exposure levels varying between and within individuals. SPHERL~     addresses to what extent between-subject differences or within-subject changes in lead~     exposure may have a measurable impact on blood pressure, the cardiovascular system, renal~     function, the autonomic nervous system, peripheral nervous conduction velocity, and~     neurocognitive function.~      At the beginning of December 2015, 70 participants were included in the study.~   "
62139|NCT02243891|"~     The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in~     hypertensive subjects is more effective when a ROX coupler is inserted concurrently.~   "
62140|NCT02243878|"~     This study investigates the use of radiation to treat wet age-related macular degeneration~     (AMD). The radiation is delivered using a robotically controlled device that projects~     overlapping beams of radiation onto the macula, the part of the eye that is affected by wet~     AMD. Participants will be randomized to receive radiation (stereotactic radiotherapy) or~     simulated placebo treatment (sham control). They will be followed up regularly for two~     years, and then again at the end of three and four years for a safety visit. Participants~     will also receive injections of ranibizumab (Lucentis) into their eye if their wet AMD is~     active. Ranibizumab is the standard anti-VEGF agent that is used to treat wet AMD. The study~     aims to determine if stereotactic radiosurgery can maintain vision and reduce the need for~     such regular anti-VEGF injections.~   "
62141|NCT02243865|"~     The purpose of this pilot study is to evaluate the performance of the Chordate System, in~     terms of the prophylactic effect and tolerability of treatment in patients diagnosed with~     migraine.~   "
62175|NCT02243423|"~     This study aims to compare the neonatal acid-base status of women who remain supine~     horizontal, with women who are tilted to the left side by 15° during elective cesarean~     delivery at term under spinal anesthesia, with systolic BP maintained at baseline with a~     phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine~     horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.~     The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The~     investigators will also examine the effects of maternal position during cesarean section~     under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a~     correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome~     will be the total phenylephrine dose requirement at 15 minutes after spinal injection.~   "
62142|NCT02243852|"~     This study will recruit healthy controls (who have normal GH production and growth hormone~     levels) and patients identified as having GHD, who are deemed eligible for GH replacement~     therapy according to NICE guidelines. The patients recruited will have been identified as~     starting on GH by their referring clinicians and a decision made on their replacement~     therapy prior to their potential enrollment in the study. The study, or its research team,~     will have no influence on the decision as to whether a patient will start on GH, or on which~     of the many GH formulations that the patients receives. The proposed study is an~     observational study to determine how GH affects the plasma levels of Fibroblast growth~     factor 21 (FGF21) in response to treatment; and whether the change in FGF21 mirrors the~     improvement in body composition/fat deposition. FGF21 is a metabolic regulator that acts on~     multiple tissues to coordinate carbohydrate and lipid metabolism and regulate energy~     balance.~      We hypothesize that FGF-21 is expressed and secreted from liver and skeletal muscle in~     humans in response to growth hormone administration and that levels may be reduced in~     patients with GHD compared with healthy controls. Furthermore, we believe that the~     beneficial effects of long-term GH replacement on body composition (reduction in visceral~     adipose tissue, subcutaneous adipose tissue and liver fat), on improvement in lipid profiles~     and on skeletal muscle mitochondrial function involve GH-induced release of FGF21.~   "
62143|NCT02243839|"~     Prosthetic heart valve thrombosis is a serious complication with high mortality and~     morbidity The best treatment of PVT is controversial, although surgery and thrombolysis~     options have been available. In this randomized and multicenter study, the investigators~     compared thrombolytic therapy versus surgery for the treatment of patients with obstructive~     prosthetic valve thrombosis.~   "
62144|NCT02243826|"~     This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain~     induced during lumbar puncture.~   "
62145|NCT02243813|"~     The current protocol is a pilot study of the effects and possible utility of~     psilocybin-facilitated experiences for professional religious leaders.~   "
62146|NCT02243800|"~     Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and~     also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and~     synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin~     D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and~     decreases pro-inflammatory process. There is an inverse relationship, at least in some~     epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence~     and / or activity of RA. The hypothesis of our study is that natural vitamin D~     supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL)~     improves functional disability.~   "
62147|NCT02243787|"~     This study is a randomised, double-blind, placebo-controlled, sequential, ascending~     single-dose, parallel group study to evaluate safety, tolerability, biological activity, and~     systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A~     (IL-17A) antibody fusion protein) in patients with stable chronic moderate-to-severe plaque~     psoriasis. Patients will receive ascending single-doses of COVA322 or placebo as a~     constant-rate i.v. infusion, followed by 12 weeks of evaluation.~   "
62148|NCT02243774|"~     The aim of this study is to determine whether receiving a core letter signed by the Surgeon~     General or the Director of the National Vaccine Program that provides only information about~     influenza, or a core letter signed by the Surgeon General with an added basic or enhanced~     implementation prompt, will increase rates of influenza vaccination among Medicare~     beneficiaries when compared to a control group.~   "
62149|NCT02243761|"~     Families of adolescents struggling with comorbid mental illness and addiction problems~     typically experience considerable emotional, financial and social burdens. Concurrent~     disorders (CDs) within families contribute to added stress and interpersonal conflict, as~     well as disrupt normal routines such as social and occupational activities. Despite the~     difficulties associated with being a family member of youth with CD, current mental health~     and addictions practices neglect to address this population. The overall purpose of this~     project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour~     Therapy skills (DBT) based training group for families of youth with CDs. The following main~     hypothesis will be examined: Family members of youth with concurrent disorders who~     participate in a 12-week skills group led by therapists and/or peer facilitators will show~     reduced caregiver burden and parenting stress from pre to post treatment.~   "
62150|NCT02243748|"~     This clinical trial studies a palliative care intervention in improving symptom control and~     quality of life in patients with stage II-IV non-small cell lung cancer and their family~     caregivers. Palliative care programs can provide patients and their caregivers with~     information on how to manage their symptoms, maintain health and well-being, and access~     supportive care services. An interdisciplinary palliative care model may effectively link~     lung cancer patients to the appropriate supportive care services in a timely fashion.~   "
62151|NCT02243735|"~     The aim of this multicenter trial is to determine the efficacy of preoperative intravenous~     iron suppletion in comparison with the standard preoperative oral substitution in anaemic~     patients with colorectal cancer in curing the anemia and the assess the effect of~     preoperative iron on morbidity, postoperative recovery and quality of life.~      Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with~     intravenous iron will lead to a higher percentage of patients with normalization of Hb-level~     (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially~     reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be~     more cost effective compared to current practice with oral substitution of iron.~   "
62152|NCT02243722|"~     Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing~     disturbance, which often happens after the treatment for laryngopharyngeal and esophageal~     cancer and may induce fatal complications such as aspiration pneumonia. By the conventional~     examinations, the tiny sensory or motor changes are hard to be detected before complete~     vocal paralysis. It is utmost important to establish a comprehensive quantitative method~     which is sensitive enough to evaluate the neuromuscular functions. The present project will~     evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was~     developed by the research team, and another novel examination technique, mucosal membrane~     sensation test. The comprehensive method is expected to grade the laryngeal nerve injuries~     quantitatively before the significant symptoms or complications and can also help to~     evaluate the treatment effect from medicine, rehabilitation or surgery.~   "
62156|NCT02243670|"~     This study uses an artificial intelligence platform to automatically confirm medication~     ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant~     platform can be downloaded as an 'app' onto any smartphone to automate directly observed~     therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically~     sent to a centralized web-based dashboard for use by healthcare professionals or research~     staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to~     confirm the process of medication administration; no human review is necessary.~      The purpose of this study is to evaluate the feasibility and acceptability, and measure the~     accuracy, of the AiCure platform (platform) in patients being treated for opioid~     dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1)~     to assess the feasibility and acceptability to both participants and study staff in using~     AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to~     optimize care pathways; and 3) to measure the reliability and validity of AiCure in~     detecting interruptions in treatment. To assess feasibility and acceptability of the~     platform, we will measure rates of physician satisfaction and user acceptance. Optimization~     of care pathways will be measured by assessing the sustainability of AiCure use over 12~     weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to~     historical data. Reliability and validity of AiCure will be measured by comparing AiCure~     adherence against pharmacokinetic data.~      All participants will be requested to take each of their prescribed doses using the app.~     Participants will be able to download the app onto their own smartphone or will be~     provisioned a device at the start of the study. The data captured during the medication~     ingestion process will be automatically encrypted and stored on the participant smartphone~     and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed~     dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be~     sent to study staff via email or SMS to prompt immediate intervention. In addition, all~     participants will receive treatment as usual.~   "
62157|NCT02243657|"~     The study investigates how safe ASP3652 is and how well it is tolerated when taken as~     multiple doses. The study also assesses how quickly and to what extent it is absorbed and~     eliminated from the body. In addition, the effects of age and gender are investigated.~      The study consists of two parts. In Part 1 four dose levels are administered to four~     separate groups initially. Two additional dosages are then investigated. Subjects receive~     either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.~      Part 2 is performed in one group of elderly healthy male or female (post-menopausal)~     subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.~      For both parts of the study, the subjects stay in the clinic for one period of 18 days.~   "
62158|NCT02243644|"~     Comparing the effect of two different duration of same drug albendazole in patients with~     Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.~   "
62159|NCT02243631|"~     This study will investigate the hypothesis that probenecid, a medication currently used for~     gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate~     deposition disease (CPPD), another common type of crystal-related arthritis. There is good~     evidence that CPPD results from an excess of ATP in joints. The investigators will measure~     levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This~     study will serve to rationalize larger studies of probenecid in CPPD.~   "
62160|NCT02243618|"~     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc~     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a~     time-consuming procedure that requires a high level of endoscopic skill to achieve a~     desirable oncologic outcome. Several procedure-related complications may occur after ESD.~     Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and~     patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are~     administered after ESD. In addition, ulcer protective agents such as rebamipide can be added~     to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for~     healing of iatrogenic ulcer.~   "
62161|NCT02243605|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of~     improvement. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and may also prevent the growth of new blood vessels that~     tumors need to grow.~   "
62162|NCT02243592|"~     This pilot research trial studies molecular profiling in tissue samples from patients with~     cancer who got better with treatment that didn't work for most other patients with the same~     disease. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify~     biomarkers related to how well patients respond to treatment.~   "
62163|NCT02243579|"~     This phase II trial studies how well pembrolizumab works in treating patients with stage~     IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement~     or has not responded to at least one type of treatment. Monoclonal antibodies, such as~     pembrolizumab, may block cancer growth in different ways by targeting certain cells.~   "
62164|NCT02243566|"~     The purpose of the study was to examine the effect of six- to eight-week treatment with~     MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure~     control. In addition, the post-marketing surveillance study offered the possibility to~     obtain information about the influence on different laboratory parameters during treatment~     with MicardisPlus® from an unselected patient group under office conditions~   "
62165|NCT02243553|"~     Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir~     500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp)~     biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine,~     warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.~   "
62166|NCT02243540|"~     The aim of this study was to evaluate an impact of preoperative bladder underactivity on~     treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser~     enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to~     compare it between the two types of surgery for benign prostatic hyperplasia.~   "
62167|NCT02243527|"~     The effects of inspiratory muscle training (IMT) remain controversial. Many studies have~     examined the effect IMT has on exercise performance, but any changes to the body that come~     from IMT have yet to be looked at.~      This study will look at how someone breathes can change after IMT. Understanding how IMT~     changes the body can help us use IMT in different treatments.~   "
62168|NCT02243514|"~     Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these~     conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an~     important part in the autonomic nervous system regulation, especially in cardiovascular~     system, the modulation of the renal nerves used as a therapeutic strategy has been~     researched across the world. The purpose of this study is to evaluate and quantify the~     morphology changes in different diseases, make the modulation therapy more selective and~     effective.~   "
62169|NCT02243501|"~     Up to 25% of children suffer from sleep problems that are referred to as 'behavioural~     insomnia'; that is, they have difficulty settling, falling asleep, and staying asleep. This~     leads to inappropriate daytime sleepiness and negatively effects behaviour, mood, and school~     performance. It also has negative effects on parents' sleep and their daytime functioning.~     Although there are methods for treating these problems, few children receive these~     treatments, and many get inappropriate treatments like medications. Only about 1% of~     children with insomnia are treated with the behavioural approaches that have been shown to~     work. The main reasons for this are that most parents are unaware of what the right~     treatments are, and most health care providers they contact do not have the training to~     provide these treatments. The Better Nights/Better Days Pediatric Sleep Team will address~     these barriers by developing, putting in place, and testing the usefulness of a sleep~     treatment program for children aged 1-10 years with behavioural insomnia that will be~     delivered over the internet, with added telephone support. This approach will make the~     treatment program available to the majority of parents whose children have insomnia. The~     investigators will test whether parents make good use of this program and whether it is~     effective in improving sleep among children. The investigators will also study whether~     improved sleep results in better daytime functioning for children and for the sleep and~     functioning of parents. The investigators will provide information to health care providers~     on how to use this treatment program. This approach will help ensure that the program will~     continue after the proposed research study ends. The proposed research program will~     therefore address an important public health issue by creating new knowledge and by turning~     this knowledge into a better way of delivering health care, thereby improving the health and~     well-being of Canadian children and parents.~   "
62170|NCT02243488|"~     This study builds on the pilot work of the Irise research group to investigate the impact of~     menstrual hygiene interventions on East African girls' school attendance, activities of~     daily living and self-esteem. The trial will be carried out in 40 schools to either~     intervention or control arms. Schools will receive a menstrual hygiene program, including~     the distribution of reusable sanitary pads and menstrual health education. The impact of the~     programme on girls' school attendance will be monitored using the validated Irise~     questionnaire and school registers. The impact of the programme on activities of daily~     living during menstruation and self-esteem during menstruation will also be measured using~     the Irise Questionnaire and explored using focus groups.~   "
62171|NCT02243475|"~     Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact~     on patients' quality of life and health care costs. Not all individuals with neuropathy~     develop pain and it is not possible to predict who is more or less susceptible among those~     with similar risk exposure. Current inability to identify high-risk individuals hinders~     development and application of therapies to counteract neuropathic pain and to address~     targeted prevention strategies. Recently, the investigators Consortium has identified novel~     pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to~     play a critical role in the generation and conduction of action potentials in nociceptors~     and their terminal axons. This study was undertaken in a carefully selected group of~     patients with painful neuropathy using a candidate gene approach and directly revealed~     targets for new therapeutic strategies. This discover widened the spectrum of sodium~     channel-related pain disorders including conditions more common in the general population~     than those known so far. PROPANE STUDY, starting from the hypothesis of a common origin of~     neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to~     develop this original idea in a larger and well characterized study population, to provide~     evidence for the reliable stratification of patients at high risk and potential new~     treatments tailored on patients' clinical features, in order to improve their quality of~     life.~   "
62172|NCT02243462|"~     Shivering is one of the most commonly recognized problem associated with anesthesia, It is~     believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient~     prior to the surgery can reduce the chances of hypothermia induced shivering during the post~     operative period.~      Forced air warmers are the most frequently used active warming devices in the peri-operative~     setting. Currently, our hospital does not pre-warm patients but if our study shows that~     pre-warming reduces post-operative shivering, we will be able to make an evidence based~     decision to start this practice.~   "
62173|NCT02243449|"~     During weaning the work of breathing is transferred from the ventilator back to the patient.~     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of~     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to~     identify weaning candidates. The investigators work demonstrates that once daily screening~     is the current standard of care. The conduct of daily ward rounds and once daily screening~     in ICUs is poorly aligned with the rapidly changing clinical status of critically ill~     patients. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a~     significant opportunity exists to screen patients more often, conduct more SBTs, and reduce~     the time spent on ventilators and in the ICU. Only one mechanical ventilation trial has~     focused on the elderly and no trial has evaluated weaning outcomes in the elderly and very~     elderly which may be influenced by the presence of comorbidities, frailty, malnutrition and~     treatment limitations.~      The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years)~     critically ill adults comparing 'once daily' screening to 'at least twice daily' screening~     in 8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to~     recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess~     whether protocols can be adhered to similarly between elderly (65 to 80 years) and very~     elderly (>80 years) trial participants. Moreover, they will also address generalizability~     issues in the conduct of mechanical ventilation research by evaluating potential biases~     associated with exclusion criteria and consent between elderly and very elderly patients and~     obtain preliminary estimates of differences in important clinical outcomes between elderly~     and very elderly participants.~   "
62174|NCT02243436|"~     Most patients suffering from Hodgkin's lymphoma (HL) can be successfully treated with~     standard chemo- and/or radiotherapy. However, in patients with refractory disease/relapsing~     after first line of therapy, conventional-dose chemotherapy regimens induce low remission~     rates, with long-term disease free survival not higher than 10% of patients.~      High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become~     the standard treatment for these patients. This treatment approach results in long-term~     remissions in approximately 40-50% of relapsed patients, and in up to 25-30% of those with~     primary refractory disease. The possibility of a cure depends on several prognostic factors,~     however, in almost all series, the strongest prognostic factor has been the disease status~     before ASCT. Patients with HL who do not achieve complete remission (CR) after induction~     chemotherapy and those with unresponsive relapse have a very poor prognosis. Therefore, the~     choice of a very active pre-transplant salvage chemotherapy regimen is extremely important~     to improve results after ASCT. In addition, this activity should also be combined with a~     good stem cell mobilizing potential and low toxicity profiled.~      Several pre-transplant salvage regimens for refractory/relapsed HL are currently used with~     an overall response (OR) and CR rates ranging from 60% to 88% and from 17% to 49%,~     respectively. No randomized trial exists comparing the effectiveness of these regimens.~     ESHAP (Etoposide, Solumoderin (methylprednisolone), Ara-C (Cytarabine) and cisplatin) is one~     of the most commonly used regimens. ESHAP induces an OR and CR of 73% and 41%, respectively,~     with 5% toxic deaths. In the present study, a combination of ESHAP plus Brentuximab Vedotin~     (BV) is proposed as pre-transplant therapy with the aim to improve the CR rate before ASCT.~      HL is characterized by the presence of CD30-positive Hodgkin Reed-Sternberg cells. The~     antibody-drug conjugate BV delivers the highly potent antimicrotubule agent monomethyl~     auristatin E (MMAE) to CD30-positive malignant cells by binding specifically to CD30 on the~     cell surface and releasing MMAE inside the cell via lysosomal degradation.~      Binding of MMAE to tubulin results in apoptotic death of the CD30 expressing tumor cell.~      The goals are:~      Determine the Maximum Tolerable Dose of the BV in combination with ESHAP in~     relapsed/resistant HL patients Evaluate the global and complete response rate after BV-ESHAP~     as salvage regimen prior to ASCT~   "
62176|NCT02243410|"~     It has come to our attention that there is not a general consensus of how to apply Visual~     Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.~      The assumption is that patients will grade the level of pain differently dependent on how~     VAS is presented.~   "
62179|NCT02243371|"~     The primary objective of this study is to compare the overall survival (OS) of subjects with~     previously treated metastatic pancreatic cancer treated with cyclophosphamide~     (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects~     treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).~   "
62180|NCT02243358|"~     To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy~     incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in~     combination with chemo-radiation with gemcitabine.~   "
62181|NCT02243345|"~     Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or~     tissues during a reduction in environmental pressure (decompression). Bubbles have~     mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.~     By reducing bubble volume and hastening inert gas elimination, recompression therapy with~     hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol~     used, is based on US Navy Treatment table 6, started as early as possible after surfacing.~     The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the~     patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.~      The significance of time to recompression is controversial. It has been suggested that early~     hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further~     tissue injury. However, in recent studies time to recompression had very little effect on~     clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has~     not been determined yet.~      The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment~     to divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after~     surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early~     treatments given at the same hyperbaric unit.~   "
62182|NCT02243332|"~     The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular~     electrical stimulation to assist quadriceps muscles as a user walks. This study will involve~     use of this device on individuals with patellofemoral pain, a relatively common injury among~     active people, to see if quadriceps stimulation could mitigate disparities in quadriceps~     activation timing that may indirectly lead to knee pain.~   "
62183|NCT02243319|"~     The purpose of this study is to investigate the pharmacokinetic drug interactions between~     HGP1201 and HGP0904~   "
62184|NCT02243306|"~     GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible~     factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of~     anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site~     of elimination for many drugs and their metabolites, and GSK1278863 will be administered to~     subjects with various stages of renal disease, it is important to characterize the~     pharmacokinetics in this target patient population. The purpose of this study is to~     characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end~     stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,~     open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in~     two cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory~     peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD~     (cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once~     daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.~   "
62185|NCT02243293|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or~     ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV~     genotypes 2, 3, 4, 5 or 6 infection.~      In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment~     with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without~     cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in~     GT2-infected DAA-naive subjects without cirrhosis.~   "
62186|NCT02243280|"~     The purpose of this study to evaluate the efficacy, safety, and pharmacokinetics of~     co-administration of ABT-493 and ABT-530 with and without ribavirin in subjects with HCV~     Genotype 1, 4, 5, and 6 infection.~   "
62187|NCT02243267|"~     The investigators are creating a data and specimen repository to study causes , early~     detection, prevention and treatment of colon and rectal cancer. The investigators are~     collecting data and specimens (blood, stool, urine and tissue) from people who have colon or~     rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.~     Data and samples are held in the repository until there are enough to be used for a large~     study or until there are new techniques that can be used to test them. The GI SPORE Program~     at the University of Michigan maintains a repository of specimens for colorectal diseases~     that the investigators hope will help fuel new research. The investigators hope that this~     work may lead to new treatments or earlier detection of colorectal cancer or improved~     diagnosis and treatment of other colon and rectal diseases.~   "
62188|NCT02243254|"~     Postoperative hyperalgesia has been reported after intraoperative administration of small or~     high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the~     development of opioid-induced hyperalgesia. The aim of this study is to evaluate the~     preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia~   "
62189|NCT02243241|"~     Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg~     tablets) on the QT/QTc interval.~   "
62190|NCT02243228|"~     The purpose of the study is to evaluate if inhaled granulocyte-macrophage colony stimulating~     factor delay the increase in alveolar-arterial oxygen difference, compared to no treatment,~     for adult patients with mild-to-moderate autoimmune pulmonary alveolar proteinosis in China~     over a two-year period.~   "
62216|NCT02242890|"~     This study has two goals: 1) to test an approach to helping women who use intrauterine~     contraception (IUC) spread the word about this type of long-lasting, highly effective birth~     control method among their friends and family and; 2) to test ways of getting in touch with~     these women's friends and family so that investigators can track whether this approach is~     effective at spreading birth control information through social groups.~   "
62217|NCT02242877|"~     The aim of this study is to compare the effect of treatment with telmisartan on patients in~     whom the systolic BP is approximately 12 weeks after starting treatment under control for~     the first time between patients with isolated systolic hypertension (ISH) at the beginning~     to patients with systolic/diastolic hypertension (SDH)~   "
62191|NCT02243215|"~     The study is a randomized study exploring the difference between off-site vs. on-site~     training in laparoscopic skills. The study will be performed using fifty surgical trainees~     from the departments of urology, surgery and gynecology. The participants will be recruited,~     enrolled and randomized during the introductory course in basic laparoscopic techniques held~     six times annually at Center of Clinical Education(CEKU).~      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual~     Reality Simulator(VRS). They will practice until they reach a predefined level of~     proficiency on seven basic modules, the procedure module; salpingectomy on the LapSim™ and~     reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic~     Techniques(TABLT) technical test.~      The intervention group will have a portable trainer available to allow training at their~     convenience, be it at home or at work. The control group will only practice on-site at CEKU~     and at their local hospital.~      Participants will be asked to keep a training log with details of time spend on training and~     number of training sessions. The training log will contain information on any type practice~     involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet~     trainer or training at CEKU. Also time spend in the operation room, assisting or performing~     laparoscopic surgery will be registered.~      To pass the TABLT all participants will book a test session at CEKU for their final test at~     the end of their training. At the test sessions TABLT test scores will be established on~     site by the Chief Investigator and afterwards using video recordings of the test. A blinded~     rater will give scores based on the video recordings and this will be the decisive rating to~     determine whether the participant has passed the test.~      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which~     proficiency level is reached.~      The enrollment of participants is expected to finish June 2015 a data analysis will be~     performed in July 2015.~   "
62192|NCT02243202|"~     The purpose of this study is to compare the effects of canagliflozin and phentermine to~     those of placebo to promote on a change in body weight over a 26 week period.~   "
62193|NCT02243189|"~     The purpose of this study is to investigate the cytokine levels in nasal lavage and gene~     expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy~     participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which~     there is wheezing and difficulty in breathing) participants with and without nasal allergen~     challenge prior to dosing.~   "
62194|NCT02243176|"~     SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active~     Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin~     Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes~     Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy~   "
62195|NCT02243163|"~     The purpose of study is to investigate if yoga exercise improve life quality and immune~     status in breast cancer patients after complete treatment (including surgery and / or~     radiotherapy and / or chemotherapy)~   "
62196|NCT02243150|"~     This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in~     humans and will allow further development of G1T28 1 in patients with cancer to reduce~     chemotherapy-induced myelosuppression.~   "
62197|NCT02243137|"~     This is a phase I clinical trial in healthy volunteers comparing the effect of lysine~     acetylsalicylate or aspirin on platelet function.~   "
62198|NCT02243124|"~     The purpose of the study is to test the safety of six cycles of cenersen treatment and to~     begin to test the hypothesis that intermittent administration of cenersen may lead to a~     reduced dependence on transfusion.~   "
62199|NCT02243111|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package; i.e. the transthoracic~     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS signals~     that are related to pulmonary hypertension.~      The TPD performance in detecting PAH in SSc patients will be assessed in the study.~   "
62200|NCT02243098|"~     The trial is conducted in Europe. The aim of the trial is to investigate the influence of~     semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of atorvastatin and digoxin in healthy subjects.~   "
62201|NCT02243085|"~     The aim of this study was to investigate the incidence of de novo urge urinary incontinence~     after the photoselective vaporization of the prostate for benign prostatic hyperplasia using~     the validated overactive bladder symptom score, and to determine the predictors of de novo~     urge urinary incontinence following the photoselective vaporization of the prostate.~   "
62202|NCT02243072|"~     Adolescents with T1D and chronic poor metabolic control are at high risk for short and~     long-term diabetes complications and are heavy users of both medical resources and health~     care dollars. The purpose of the proposed study is to collaborate with a community agency to~     develop and test an intervention, Fit Families, that uses the core components of a~     previously successful home-based family treatment, but that can delivered by lower cost~     community health workers. If successful, Fit Families could improve health outcomes in a~     vulnerable population at high risk for diabetes complications, and could be translated to~     real-world treatment settings.~   "
62203|NCT02243059|"~     Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting~     with advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging~     strategies to depict involved lymph nodes are currently not successful. The purpose of this~     study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium~     contrast enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify~     involved lymph nodes in a preoperative setting. This could guide the surgeon during surgery~     to dissect lymph nodes which could lead to an optimal diagnosis/staging with the lowest~     possible morbidity. We want to determine the optimal imaging settings and feasibility of MRI~     for the detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV)~     ovarian cancer undergoing primary debulking surgery and compare this to conventional imaging~     with computer tomography (CT).~   "
62204|NCT02243046|"~     This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one~     hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.~   "
62214|NCT02242916|"~     Given that the cost of proton therapy is considerably higher than that of conventional~     radiotherapy with photons, it is necessary to establish whether these higher costs are~     worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations~     in which proton therapy outperforms conventional photon treatment is needed. The~     investigators therefore aim to demonstrate through an in silico trial that proton therapy~     decrease the amount of irradiated normal tissue and, consequently, the risk of side effects~     in the surrounding normal tissue as well as the risk of secondary tumors. The same overall~     treatment time and an equal number of fractions will be used for both treatment modalities~     wherever possible. The most optimal technique for each individual patient, based on~     objective criteria related to limiting dose to normal tissue, will be prescribed by the~     institution concerned for each treatment option.~   "
62205|NCT02243033|"~     Target recruitment: 1000 subjects. The purpose of this research study is to continue to~     investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal~     therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize~     that laser focal therapy can be used to achieve oncologic control in carefully selected~     patients.~      MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses~     light to heat a target area to try to destroy cancerous cells.~      The laser system that will be used is called the Visualase® Thermal Therapy System. This~     system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.~     However; this study is the first time this system has been studied for use in the treatment~     of prostate cancer with a trans-rectal approach.~      MR-guided biopsies and laser applicator placement will be performed using the Invivo~     DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S.~     Food and Drug Administration (FDA) for such uses.~   "
62206|NCT02243020|"~     The primary study objectives are to assess the safety and feasibility of the therapy,~     including the surgical intervention and stimulation, as well as to provide information on~     the appropriateness of the study test measures (assessments) and to provide a basis for~     sample size calculations for a larger, pivotal study.~   "
62207|NCT02243007|"~     This research study is a Phase II clinical trial, which evaluates a combination of drugs,~     FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable~     pancreatic cancer prior to surgery.~   "
62208|NCT02242994|"~     The purpose of this study is to evaluate a touch screen application designed to help~     pediatric patients with cerebral palsy communicate. The study will test how well patients~     type on two different tools: one tool is already on the market , and the second tool is a~     newly developed App.~   "
62209|NCT02242981|"~     This type of study is called a radiolabeled study. For this study, LY2623091 (study drug)~     has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally~     occurring radioactive form of the element, carbon. This study will increase understanding~     about how the drug appears in the blood, urine, and stool after it is administered to~     healthy participants. Information about any side effects that may occur will also be~     collected. This study will last up to 22 days for each participant, not including screening.~     Screening is required within 28 days prior to enrollment~   "
62210|NCT02242968|"~     Background:~      - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group~     of healthy volunteers for clinical trials. Clinical trials are studies that test these~     vaccines and therapies in people.~      Objective:~      - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs~     to treat or prevent virus infections.~      Eligibility:~      - Healthy adults age 18 65.~      Design:~        -  Participants will be asked questions about their health history, including sexual~          activity and drug use. They will give blood samples. They may have a physical exam.~          They may give a urine sample.~        -  Participants may have the inside of their nose either swabbed or washed with some~          fluid. The fluid will be collected. They may give a stool sample.~        -  Participants may have an electrocardiogram. Soft, sticky patches will be attached to~          participants chest, arms, and legs. They will lie still on a table while the patches~          detect the heart s electrical signals. A machine will record these signals.~        -  Participants may have lung function tests. These tests measure the volume of air moving~          in and out of the lungs. Participants will forcibly blow air into a machine.~        -  Participants will be told if any tests show a medical problem.~        -  If a participant is eligible and decides to join an investigational clinical trial,~          researchers will explain the study and the risks involved. Participants will sign a~          separate consent for that clinical trial.~   "
62211|NCT02242955|"~     Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol~     withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference~     medication for preventing or treating AWS. The recommended average diazepam treatment~     duration is usually around one week, and this duration is generally not considered to impact~     the subsequent relapse rate in alcohol drinking.~      However, several previous studies have found that patients experienced frequent anxious~     symptoms during the weeks following detoxification. Such symptoms may foster early relapse~     in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to~     late withdrawal symptoms.~      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one~     month can significantly reduce the cumulated relapse rate in alcohol drinking over the three~     following months.~   "
62212|NCT02242942|"~     This open-label, multicenter, randomized Phase III study is designed to compare the efficacy~     and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +~     chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical~     conditions. The anticipated time on study treatment will be approximately one year and the~     follow-up period will be up to 5 years.~   "
62213|NCT02242929|"~     Basal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin~     tumour. It is the most common malignant disease in Caucasians, representing approximately~     80% of all cases of skin cancer and is therefore an important health problem. In the~     Netherlands incidence rates are 165 for men and 157 for women per 100.000 person-years, and~     these rates are rising with 3-10% every year.~      A simplified histological classification of BCCs includes the following three subtypes:~     nodular, superficial and infiltrative variants, with the nodular variant being the most~     frequent type. Although a characteristic feature of BCCs is their low risk to metastasize,~     if untreated they may be locally invasive and may induce considerable functional and~     cosmetic morbidity.~      The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but~     not all patients are eligible for surgery. In patients with multiple BCCs and older~     patients, surgery may lead to significant morbidity, and in some cases, it may result in~     disfiguring scarring. For these reasons and to reduce workload and costs in the healthcare~     system, there is a growing demand for alternative, non-invasive, treatments. An advantage of~     non-invasive treatment options is that they can be performed by other healthcare~     professionals, such as general practitioners and specialized nurses. For treatment of~     superficial BCCs (sBCC) non-invasive treatments, such as topical imiquimod (IMQ),~     5-fluorouracil (5-FU) or photodynamic therapy (PDT) are already commonly used. Our group~     investigated the efficacy of those three therapies and found that after 3 years, BCCs~     treated with IMQ had a significant lower risk of recurrence, compared to the other~     therapies.~      A recent study suggests that IMQ, besides being an immune-response modifier, also directly~     inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This~     targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of~     nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy~     rates were found, although efficacy was still slightly inferior to SE.~      The investigators hypothesize that the effectiveness of IMQ following prior curettage will~     not be inferior to SE and that the benefits will be a higher patient satisfaction and lower~     healthcare costs. A recently published discreet choice experiment showed that patients~     preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.~   "
62218|NCT02242864|"~     The primary objective was to evaluate the effect of the treatment with Micardis® or~     MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® /~     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose,~     insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential~     hypertension and diabetes mellitus~   "
62219|NCT02242851|"~     Primary objective: to characterize hypertensive patients treated for at least 1 month with~     Telmisartan (alone or in combination with other drugs) in order to define the beneficiary~     population (those actually receiving the treatment).~      Secondary objectives:~        -  to describe the patients' blood pressure values (when self-monitored) and satisfaction~          with the treatment (ease of use, efficacy, safety) on the basis of a patient~          self-questionnaire, filled out 4 weeks after consultation.~        -  to compare the characteristics of the beneficiary population to those of the initial~          target population defined in the SPC (summary of product characteristics) for~          Telmisartan~   "
62220|NCT02242838|"~     The primary objective of this survey is to prospectively investigate safety and efficacy in~     patients with hypertension treated with telmisartan in proper use in medical practice over a~     long period~   "
62221|NCT02242825|"~     The primary objective is to evaluate the effect of the treatment with Micardis® or~     MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® /~     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c)~     in patients with essential hypertension and diabetes mellitus~   "
62222|NCT02242812|"~     The primary objective was to show that telmisartan is not inferior to metoprolol succinate~     in respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment~     period. As secondary objectives, the improvement in left ventricular systolic and diastolic~     function and blood pressure reduction were assessed~   "
62223|NCT02242799|"~     Malaria and HIV are found in the same regions of the world and developing countries are most~     affected by both diseases. For malaria, new drugs have been introduced called ACTs. These~     drugs are effective against malaria but little is known about how the levels of these drugs~     in blood relate to how effective these drugs are. For HIV, a new drug has been developed~     called dolutegravir which has potential to be widely used in developing countries. This~     proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs~     and vice versa. In total, 46 healthy volunteers will participate in this study.~   "
62224|NCT02242786|"~     Recently, diffusion-weighted (DW) MR imaging has widened its application on various~     oncologic applications. Especially, it is expected the DW MRI could provide valuable~     information about early response evaluation after treatment using rapid apparent diffusion~     coefficient (ADC) value change. It has demonstrated potential usefulness in response~     evaluation in the liver tumors after treatments such as transarterial chemoembolization~     (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that~     does not require a contrast agent, it can be safely used in patients with renal~     insufficiency or other medical contraindications for contrast agents.~      The optimal assessment of early response of RT could provide one of the most important~     information to prescribe patient and cancer specific RT dose. It might be also important in~     palliative RT of HCC bone metastasis which is related with painful aggressive mass~     formation.~      This study is performed to evaluate the usefulness of DW MRI in early response evaluation~     after RT for HCC bone metastasis.~   "
62225|NCT02242773|"~     1. Multiparametric MRI ultrasound (MRIus)-guided or direct MRI-guided biopsies will allow~          for more directed sampling of the tumors from compartments with distinct~          multiparametric-MRI (MP-MRI) characteristics, termed habitats, that will increase the~          rate of progression on early (first and second) surveillance biopsies and decrease~          the rate of progression on late (third and further) surveillance biopsies compared to~          historic transrectal ultrasound (TRUS)-guided biopsy rates.~        2. Identifying higher risk tumor early on will reduce the proportions of patients with~          poor response to delayed primary treatment.~        3. Radiomics signatures from MP-MRI will define patterns that are associated with~          progression.~        4. Genomic signatures based on RNA from tumor tissue will define patterns that are~          associated with habitats and radiomics signatures, as well as progression.~   "
62226|NCT02242760|"~     This is a randomized, multi-center, double-blinded study in subjects with moderate to severe~     acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2~     concentrations of a topical drug in development or a vehicle. Subjects will be treated for~     up to 12 weeks.~   "
62227|NCT02242747|"~     Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic~     keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.~      Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial~     AKs.~      Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients~     with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three~     consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was~     evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT~     populations.~   "
62228|NCT02242734|"~     Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of~     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules~   "
62229|NCT02242721|"~     Approximately 300 patients have to be enrolled in the study. They are followed up until the~     end of ICU stay. Usually in clinical routine, patients suspected to have infection and~     simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and~     dialysate specimens are drawn and sent for analysis on specific time points. The analysis~     results are sent back to the study team at the Charité - Universitätsmedizin Berlin and~     enable them to optimize antiinfectiva treatment of the study patients.~      Data are used to test calculation tools and modify them if necessary.~   "
62230|NCT02242708|"~     The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative~     nostril breathing to improve life quality, autonomic nervous system and immune status.~   "
62231|NCT02242695|"~     A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg~     dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in~     patients suffering from vulvovaginal candidiasis, to assess safety of the two medications~     during the treatment, and to evaluate women's satisfaction with the two treatments.~   "
62233|NCT02242669|"~     The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target~     individuals with psychiatric diagnoses such as mood disorders, and provide evidence either~     supporting the expansion of such groups and the development and testing of clinical~     procedures, or point toward reevaluation and development of alternative low-cost, community~     based approaches to promoting recovery among individuals suffering from these disorders.~   "
62234|NCT02242656|"~     MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people~     with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the~     symptoms of Short Bowel Syndrome and reduce the number of times subjects experience bowel~     movements.~   "
62235|NCT02242643|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®~     Quadrivalent in children 6 to 35 months of age.~   "
62236|NCT02242630|"~     It is currently unknown whether or not the improvement in pain and function related to a~     steroid shot for shoulder pain due to subacromial bursitis is important. This study seeks~     to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone~     significantly affect improvement in shoulder pain 6 weeks after injection.~   "
62237|NCT02242617|"~     Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians.~     It is the cause of significant healthcare costs with increased morbidity and mortality. The~     two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic~     Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both~     therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance,~     cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness~     and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use.~     Until now, studies have used self-reported adherence data on MAS versus objective adherence~     on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is~     counterbalanced by the superior adherence relative to PAP, resulting in a similar~     effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS~     and could be used to prove this hypothesis and allow a new and complete comparison of~     effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's~     objective adherence and long-term symptomatic improvement would provide vital information to~     doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will~     receive both PAP and MAS in a random sequence. This innovative study lead by two experienced~     new investigators, and a research team of multidisciplinary experts, will assess objective~     adherence, treatment efficacy, patient preference, sleepiness and quality of life of each~     treatment used at home for 1 month per treatment. After this, patients will be able to go~     back and forth between both treatments during an additional 6-month period. The results of~     this study will be used by healthcare policy makers as well as clinicians who need to be~     part of the treatment plan decision for the many Canadians who suffer from sleep apnea.~   "
62238|NCT02242604|"~     Our purpose is to investigate the improvement of the cognitive, neuropsychologic and~     physical capabilities using a standardized multidimensional geriatric assessment (MGA)~     consisting of a battery of validated assays after correction of hyponatremia in patients 70~     years or older.~   "
62239|NCT02242591|"~     The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs.~     placebo on muscle strength, mobility and pain on the first postoperative day after total~     knee alloplastic (TKA).~   "
62240|NCT02242578|"~     Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal,~     affective flattening, poor motivation, and apathy) with medications and psychotherapy are~     almost non-existent, whereas treatment of the positive symptoms (hallucinations and~     delusions) has been more effective with psychotropic medications. The proposed research on~     human subjects using a non-invasive technology (such as repetitive transcranial magnetic~     stimulation [rTMS]) will provide efficacy data for treating negative symptoms.~      The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and~     frontal cortical networks associated with attentional processes as a component of the~     distracted affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the~     reticular activating system (RAS), and this will allow the mutism, which is a negative~     symptom, to be partially improved.~   "
62241|NCT02242565|"~     The purpose of this study is to assess the safety of ShangRing MMC procedures when providers~     choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14~     adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.~   "
62242|NCT02242552|"~     A new research paradigm that involves sequencing tumor DNA/RNA to identify driver mutations,~     select among the Health Canada approved drugs (for adult cancers) known to block certain~     oncogenic pathways, and recommend these drugs to the treating physician, without taking into~     account the tumor histology.~      In this paradigm, the treatment is targeted to the actionable mutation(s) i.e. those driving~     oncogenesis. It is also personalized to the molecular signature of the patient's tumor,~     irrespective of its histopathological subtype. The experience of the investigators team in~     genomics, including next generation sequencing and bioinformatic analysis combined with the~     clinical expertise, bring at last this approach within our technical capacities. In~     parallel, the number of Health Canada-approved drugs (which have been tested in a pediatric~     setting) designed to interfere with oncogenesis pathways is increasing exponentially.~   "
62243|NCT02242539|"~     In this study, we aim to improve child nutrition by increasing parents' awareness of their~     children's physical growth. We use a cluster-randomized trial design to evaluate two~     interventions that provide parents with regular information on their children's physical~     development and growth: 1) distribution of full-sized growth charts for measurement of child~     height within households; and 2) organization of community-based meetings, during which~     children's height and weight are measured by trained project staff.~   "
62244|NCT02242526|"~     The investigators propose a randomized, single blinded controlled trial to compare the use~     of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard~     of care surgical modalities. The investigators hypothesize that use of synthetic mesh will~     have lower recurrence at these time points compared to use of biologic mesh.~   "
62245|NCT02242513|"~     Although there are many conservative method for plantar fasciitis, patients might spend 2~     years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF)~     lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no~     studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using~     ultrasound-guided (UG) techniques.~   "
63100|NCT02231346|"~     New perceptions about handling and patient satisfaction of the everyday use of Berodual®~     Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease~     (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual®~     Respimat®~   "
62246|NCT02242500|"~     The purpose of this study is to compare the clinical outcomes after coronally advanced flap~     technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment~     of single gingival recessions. For this blinded randomized controlled clinical trial, 40~     patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will~     selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters~     evaluated will be probing depth, clinical attachment level, gingival recession height,~     height and thickness of keratinized tissue. Clinical measurements will be taken at baseline~     and 45 days, 2, 3 and 6 months after surgery.~   "
62247|NCT02242487|"~     This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of~     CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor~     fluctuations (OFF episodes). All patients will receive active treatment, but patients will~     be blinded to dose level. This will serve as an extension to the CVT-301-004 study for those~     patients who participated in that study and remain eligible for this study. In addition,~     patients who previously completed the CVT-301-003, CVT-301-009 and CVT-301-005~     (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they~     meet the CVT-301-004E eligibility criteria.~   "
62248|NCT02242474|"~     Rheumatoid arthritis (RA) is a frequent inflammatory arthritis that can lead to severe joint~     deformity and often requires orthopaedic surgical interventions. Anti-Tumor Necrosis Factor~     α (anti-TNFα) are biological disease-modifying antirheumatic drugs (DMARDs) increasingly~     used in the treatment of rheumatoid arthritis. An increased risk of opportunistic infection~     was demonstrated in patients treated with those drugs. This observation led many national~     committees to recommend anti-TNFα suspension in the perioperative period to avoid a raise in~     the postoperative infection risk in those patients. This approach is not supported by the~     data available in the current literature and it exposes patients to an increased risk of~     inflammatory flare ups of their disease during and after anti-TNFα suspension, which can~     compromise their postoperative rehabilitation and their quality of life.~      The objective of this prospective randomized multicentric trial is to determine the effect~     of anti-TNFα suspension in the perioperative period on the postoperative infection risk.~     Overall, 660 rheumatoid arthritis patients requiring an elective foot or ankle surgery will~     be randomized into two groups. In the first group, anti-TNFα will be stopped 3 half-lives~     before the surgery while they will be continued in the second group. The postoperative~     infection rate will be compared between the two groups. Postoperative complication rates,~     flares and revision surgeries as well as the functional improvement will be compared.~      The study hypothesis is that there is no significant difference in the risk of postoperative~     infection between the two groups.~      Results from this study will help determine the optimal way to use anti-TNFα in the~     perioperative period and will therefore improve the quality of life of rheumatoid arthritis~     patients.~   "
62249|NCT02242461|"~     We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with~     moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation~     and anti-oxidation for these patients, and these effects (2) may reflect in the improvement~     of patients' physiological measurements, quality of life and exercise tolerance.~   "
62250|NCT02242448|"~     Background:~      - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It~     uses X-ray radiation to produce an image in three dimensions. Researchers want to study how~     to get the best quality CT scans using the lowest possible radiation dose.~      Objective:~      - To determine how to improve CT scanning.~      Eligibility:~      - Adults 45 years of age and older who have not had a CT scan in the past year and do not~     have kidney disease.~      Design:~        -  Participants will be screened with a medical history and blood and urine tests.~        -  Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for~          several hours during the magnetic resonance imaging (MRI) and CT scans. Through this~          IV, blood will be taken, dye will be injected, and medicine will be given.~        -  Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis.~          Participants will lie on their back on a table. The table will slide into a~          donut-shaped machine. An X-ray tube will move around the body, taking pictures.~        -  Participants may be given a drug called a beta blocker by mouth or through the IV tube.~        -  Participants heart rate and blood pressure will be monitored.~        -  Participants may have an MRI scan. The MRI is a large hollow tube. The participant will~          lie on a table that will be moved into the tube, which contains a magnetic field. When~          the imaging starts, a thumping sound will be heard. Headphones or earplugs will be~          provided to muffle the sound.~        -  Participants will give blood samples.~   "
62251|NCT02242435|"~     In this Phase III clinical trial, approximately 320 eligible patients with OA of the knee~     will receive Ampion™ 4 mL or Saline 4 mL (1:1) administered as three IA injections, 2 weeks~     apart at Day 0, Week 2, and Week 4.~   "
62252|NCT02242422|"~     The aim of this study was to identify the serial changes in lower urinary tract symptoms~     (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery~     for treatment of female stress urinary incontinence.~   "
62253|NCT02242409|"~     A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting~   "
62254|NCT02242396|"~     The primary objective was to evaluate, through the use of Home blood pressure monitoring~     (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in~     patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis~     Plus®, Telmisartan hydrochlorothiazide.~      The co-primary endpoints were the degree of BP control, and change from baseline until study~     end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in~     the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis~     Plus®, Telmisartan hydrochlorothiazide.~      Secondary endpoints were office BP control rates, office BP response rates, and reduction in~     mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit,~     discontinuations and tolerability~   "
62255|NCT02242383|"~     To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual~     daily-practice prescribing conditions with a special emphasis on controlling morning blood~     pressure~   "
62256|NCT02242370|"~     Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to~     establish the effect on patient's quality of life scores.~   "
62258|NCT02242344|"~     Study to assess the blood pressure lowering effects of two doses of telmisartan over a~     four-week treatment period; to determine potentially effective doses for pediatric patients~     for future studies; to assess the safety and tolerability of two doses of telmisartan.~      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics~     of telmisartan in children and adolescents aged 6 to <18 years, and to determine if~     age-related differences exist~   "
62259|NCT02242331|"~     This post-marketing surveillance study is designed to supplement under conditions of normal~     clinical practice data on safety, tolerability and efficacy of Micardis® collected in~     clinical studies with special emphasis on the control of blood pressure in the morning~     before intake of the next antihypertensive drug~   "
62260|NCT02242318|"~     The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering~     diastolic blood pressure in patients who missed a dose of their medication, as measured by~     ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to~     valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end~     of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)~   "
62261|NCT02242305|"~     In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and~     safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of~     3 days for the treatment of occasional or recurrent episodes of self-reported gastric or~     intestinal spasm-like pain or discomfort~   "
62262|NCT02242292|"~     Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of~     a single episode - defined as lasting not longer than 1 day - and multiple episodes of~     abdominal pain or discomfort associated with cramping when used as needed~   "
62263|NCT02242279|"~     Study to investigate the dose-dependent bronchodilator effect and the safety of single~     inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with~     stable Chronic Obstructive Pulmonary Disease (COPD)~   "
62264|NCT02242266|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to tiotropium 10 μg, formulated as inhalation powder in the polyethylene hard~     capsule and delivered via the HandiHaler® 2, compared to tiotropium 18 μg, formulated as~     inhalation powder in the hard gelatine capsule and delivered via the HandiHaler® (Spiriva®)~     following single dose inhalation in patients with COPD. A hard polyethylene (PE) capsule~     with half the strength (tiotropium 5 μg) was included to investigate a dose ordering effect.~      The secondary objectives were to characterize the pharmacokinetics of tiotropium inhalation~     powder hard PE capsule (delivered via HandiHaler® 2) and tiotropium inhalation powder hard~     gelatine capsule (delivered via HandiHaler®) and to compare the safety of the two~     pharmaceutical formulations.~   "
62265|NCT02242253|"~     Main Study: To evaluate and to compare the lung function response to the free combinations~     of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium~     18 μg QD at the end of 6-week treatment periods in patients with COPD.~      Sub-Study: Was performed in subset of patients participating in the Main Study to assess the~     effect of the four randomised treatments on dynamic hyperinflation.~      Extension Study: To establish whether the FEV1 time profile following combination~     bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical~     formulation of salmeterol, i.e. the MDI or the Diskus®.~   "
62266|NCT02242240|"~     Study to establish the lung function effects of added formoterol (12μg QD and BID) during~     2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)~   "
62267|NCT02242227|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder~     delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent®~     Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose~     inhalation in patients with COPD.~      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation~     powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate~     delivered by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.~   "
62268|NCT02242214|"~     The design of the study is post-marketing, observational, multi-centre and open-label. The~     study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery~     system (VDS) is prescribed may be included. All directions for medication usage and patient~     monitoring are solely at the discretion of the investigator in accordance with their usual~     practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg~     VDS. No other (invasive) study-related interventions or measurements are done, other than~     the procedures routinely performed during induction of labour. No effort is expected from~     the study subjects. 150 patients from 20 Dutch centres will be included.~   "
62269|NCT02242201|"~     Total hip arthroplasty is a one of the most commonly performed surgical procedures with~     increasing numbers anticipated over the next several decades. Differences in the analgesia~     outcomes between these three intervention groups would provide for an evidenced-based~     clinical pathway that will emerge as a result of this study.~      Hypothesis:~      Patients undergoing total hip arthroplasty within a clinical pathway utilizing preemptive~     low-dose opioid and non-opioid medications for multimodal analgesia randomized to peripheral~     nerve blockade will report less pain with movement on an NRS scale POD #1 compared to~     randomization to periarticular injection with ropivacaine mixture or periarticular injection~     with liposomal bupivacaine (Exparel&#174;).~   "
62270|NCT02242188|"~     INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy~     of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants~     beginning at 4 months of age. Uncertainty exists regarding the effects of iron~     supplementation during infancy on neurodevelopmental outcomes in the absence of anemia.~      AIM To establish whether psychomotor and mental development is influenced by early iron~     supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants.~      METHODS Healthy term newborns will be recruited shortly after birth. If predominantly~     breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to~     receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age.~     Participants will be assessed with use of Bayley Scales of Infant and Toddler Development~     (Bayley III) at 12, 24 and 36 months of age.~   "
62271|NCT02242175|"~     Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It~     is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not~     proven. So, the treatment's target is the relief of the symptoms.~      Small intestinal bacterial overgrowth considered as the cause of the irritable bowel~     syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal~     discomfort could be relieved after taking antibiotics. There are several diagnostic methods~     for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for~     diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized~     cut-off value for the hydrogen breath test. So, we want to compare the hydrogen breath test~     between the irritable bowel syndrome patients and normal people. And then, we want to~     analyze the efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.~   "
62272|NCT02242162|"~     Respiratory failure is the main death cause in muscular diseases. Non-invasive and~     volitional measures of inspiratory muscles strength include the nasal pressure with an~     occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional~     maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive~     and non-volitional technique to evaluate diaphragm strength at muscular diseases~     patients.The methdology consist to compar PImax measure to nerves magnetical stimulation~     maneuvers measure.~   "
62273|NCT02242149|"~     This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults~     treatment with diacerein will improve glycemic control and will reduce liver fat within a 24~     month period.~   "
62274|NCT02242136|"~     Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former~     conflict regions were and are often exposed to multiple traumatic events and situations in~     which they are forced to engage in violent behavior. The treatment program Formation,~     Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a~     short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress~     Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.~     Addressing trauma-related mental disorders as well as emotions related to aggression by~     means of FORNET is expected to facilitate reintegration in civil life and reduce~     uncontrolled violence.~      The investigators want to provide evidence, that FORNET is an effective and efficient module~     to assist soldiers after deployment in Somalia and/or male and female ex-combatants who~     fought in the civil war in Burundi. In addition the investigators aim to explore how~     traumatic incidences and maltreatment during childhood may influence treatment outcomes.~   "
62275|NCT02242123|"~     Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically~     predisposed populations. Patients affected by the disease may be asymptomatic or manifest~     classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss~     after gluten ingestion (and related derivatives found in other grains). Diagnosis and~     screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG)~     and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the~     criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal~     villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure~     to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in~     identifying susceptible individuals. CD diagnosis is still anchored to the criteria~     established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition~     in 1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia~     and increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten,~     and (b) a full clinical remission after elimination of gluten from the diet. As a~     consequence, patients with minimal or no intestinal histology lesions pose a considerable~     problem, as serum anti-tTG and EmA are known to be often negative, or weakly positive, in~     patients with CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG~     antibody in the culture medium of intestinal biopsy specimens from patients with suspected~     CD and evaluated the relationship between antibody production and severity of intestinal~     mucosal damage, and demonstrated that anti-tTG assay of the culture medium of biopsy~     specimens can improve the accuracy of CD diagnosis in patients negative for serum~     antibodies. The same investigators, in 2011, evaluated the diagnostic accuracy of EmA assay~     in the culture medium of intestinal biopsies for CD diagnosis and demonstrated that EmA~     assay in the culture medium had a higher sensitivity and specificity than serum EmA and~     anti-tTG assay. The present study is performed to investigate the clinical usefulness of the~     in vitro production of EmA in CD diagnosis in a large number of consecutive adult patients~     with suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG.~   "
62276|NCT02242110|"~     Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. Though~     further evidence is needed, ERRT has shown strong support in reducing the number and~     intensity of nightmares, as well as improving overall sleep quality in both civilian and~     veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar~     disorder.~   "
62277|NCT02242097|"~     This study is being done to see whether or not a drug called ibrutinib can be given to~     patients with mantle cell lymphoma (MCL) as maintenance therapy after induction~     chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive.~     The investigators hope to learn how safe and effective ibrutinib is for treating patients~     with MCL after responding to induction chemotherapy.~   "
62278|NCT02242084|"~     Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic~     events in the central nervous system (CNS). In most cases the consequences are catastrophic,~     with a high rate of severe functional disability and mortality rate up to 30%.~      Ischemic stroke of the spinal cord can arise from:~        1. Dissection of the aorta.~        2. Aneurism in the aorta.~        3. Atherosclerotic disease of the aorta or vertebral arteries.~        4. Spinal surgeries.~        5. Spinal AVM.~        6. Embolism from cardiac origin.~        7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in~          hours until the patient becomes paralyzed in two or in all four limbs. In most cases~          the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor~          weakness accompanied by disturbance of temperature and superficial sensation, urinary~          retention or bowel disorder, with preserved position and vibration sense.~      The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis~     of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).~     Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the~     spinal cord is necessary upon arrival in the emergency department.~      One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and~     validated in numerous studies for ischemic events in the brain, until today no validated~     study in ischemic spinal stroke using thrombolysis has been completed.~   "
62279|NCT02242071|"~     The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic~     Lateral Sclerosis patients.~   "
69950|NCT02141945|"~     The purpose if this study is to measure the sensitivity, specificity and accuracy of the~     Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon~     polyps or colorectal cancer.~   "
62280|NCT02242058|"~     There has been little progress for effective treatment of pain in sickle cell disease (SCD)~     patients. Many organizations have recognized that understanding the causes and reducing the~     burden of pain in SCD is critical in order to improve the quality of life in SCD patients.~     As patients with SCD face the challenge of living with both acute and chronic pain which is~     often improperly treated, our translational and interdisciplinary project aims to identify~     objective measures of pain sensitivity and its biochemical and genetic correlates. We~     hypothesize that SCD patients will have decreased tolerance to thermal and electrical~     stimuli.~   "
62281|NCT02242045|"~     This study will evaluate the 28-day safety, tolerability, and pharmacokinetics (PK) of~     idelalisib with or without ofatumumab in Japanese participants with relapsed or refractory~     indolent non-Hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL).~   "
62282|NCT02242032|"~     The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic~     Solution in subjects with mild to moderate dry eye disease.~   "
62283|NCT02242019|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in the treatment of toenail onychomycosis.~   "
62284|NCT02242006|"~     Severe acute kidney injury (AKI) is a common complication of critical illness affecting~     almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a~     cornerstone in the management of AKI in these patients. Options for renal replacement~     therapy include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or~     a hybrid form of the two called sustained low efficiency dialysis (SLED). Globally there is~     a push to switch from traditional CRRT to SLED. Although there are resource and financial~     comparative benefits to SLED there is almost no literature describing how to dose~     antimicrobials (or other drugs for that matter). It appears that drug clearance on SLED may~     be more efficient than CRRT but not as efficient as IHD making extrapolation from these~     bodies of literature inappropriate for SLED. The investigators are proposing to conduct the~     population pharmacokinetic studies for the three most commonly used antimicrobials in~     critically ill patients receiving SLED therapy (piperacillin-tazobactam, meropenem and~     vancomycin). Population pharmacokinetic modeling of these drugs will provide estimates and~     sources of variability around pharmacokinetic parameters that will subsequently be used for~     Monte Carlo simulation to determine the most appropriate dosing regimens to achieve~     therapeutic targets while minimizing the risk of toxicity.~   "
62285|NCT02241993|"~     The purpose of the study is to test the accuracy benefit of having two glucose sensors (over~     one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet~     known how close two sensors can be and still work correctly.~   "
62286|NCT02241980|"~     Evaluation of patients' methodology and ability to select an economical and ideal Medicare~     Part D prescription drug plan (PDP).~   "
62287|NCT02241967|"~     The proper control of acute and chronic pain is one of the most important areas in health~     care. Despite the profound advances in neuroscience over the past 20 years, the~     investigators still largely use opiate narcotics, much as was done in the Civil War. Total~     knee arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While~     knee pain is often a complaint that precedes TKA, the procedure itself is associated with~     considerable post-operative pain lasting days to weeks. Adequate postoperative pain control~     is an important factor in determining recovery time and hospital length of stay. New~     analgesic strategies are needed that can be used adjunctively to existing strategies with~     the potential to reduce reliance on opioid analgesia. Several novel brain stimulation~     technologies including transcranial magnetic stimulation (TMS) and transcranial direct~     current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety~     of pain conditions. Electricity has no metabolite or other residue, and can be delivered~     with minimal discomfort and without problems associated with drug-drug interactions. In two~     independent preliminary pilot studies, the Investigators have shown that tDCS can reduce~     post-operative PCA use by as much as 46% while simultaneously reducing subjective pain~     ratings. The present study aims to determine the effects of transcranial direct current~     stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and~     post-surgical complications during the 48-hour post-operative period following total knee~     arthroplasty.~   "
62288|NCT02241954|"~     The hypothesis of the study is that individuals with poor pulmonary function secondary to~     TIS will benefit from expansion thoracoplasty. The investigators specific aims are to:~        1. Record pulmonary function and thoracic volume of TIS patients at enrollment and with~          serial observation~        2. Offer expansion thoracoplasty therapy to TIS patients with~             1. poor pulmonary function at enrollment~             2. progressive decline in pulmonary function~             3. progressive chest wall and/or spinal deformity~             4. lack of appropriate increase in thoracic volume during growth~        3. Document efficacy of expansion thoracoplasty for TIS patients~   "
62289|NCT02241941|"~     The purpose of this study is to determine single dose pharmacokinetics of daptomycin~     consecutively in 10 patients on three different time points after severe burn injury.~   "
62290|NCT02241928|"~     The purpose of this study was to analyze the effect of autologous bone marrow mononuclear~     cells in muscular dystrophy.~   "
62291|NCT02241915|"~     Surgical site infections (SSI) are costly complications that may cause significant morbidity~     and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS)~     are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of~     benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we~     hypothesized that a microbial sealant could reduce the rate of SSI by half for clean~     contaminated colorectal procedures (Class 2).~   "
62292|NCT02241902|"~     The aim of this study was to identify serial changes in the incidence of postoperative~     pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the~     presence of postoperative pyuria could be correlated with surgical outcomes after surgery~     and to identify predicting factors that influence on persistent pyuria after the PVP.~   "
62380|NCT02240758|"~     Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain~     lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and~     real-time assessment of resections margins during surgery. Probe-based CLE using the~     CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the~     potential of this technique in improving surgical resection outcome, a feasability study has~     to be performed.~   "
62293|NCT02241889|"~     Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar~     are paving the way to revolutionize the management of this disease. The benefit of improved~     control of blood sugar levels compared to standard insulin pump therapy has already been~     demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably~     during exercise. The investigators research group has shown that small doses of glucagon can~     prevent low blood sugar when used in a blood sugar control system in patients with type 1~     diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the~     ability to recognize the onset of physical activity in order to appropriately adjust the~     insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.~      The purpose of this study is to test how well a new modified blood sugar control system~     controls blood sugar during exercise compared to: 1) the current system without~     modifications and 2) standard insulin pump therapy.~   "
62294|NCT02241876|"~     Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as~     the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of~     cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities~     caused mainly by oxidative stress. The objective of this study will be evaluate the use of~     n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and~     neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial~     with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital /~     University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin~     antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will~     be included in this research. They will be studied in 2 groups (n-acetylcysteine and~     placebo). All patients will be evaluated in relation to cisplatin induced hematologic and~     gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and~     cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be~     statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated~     measures tests (p<0.05.)~   "
62295|NCT02241863|"~     Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar~     disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to~     treatments is also a major obstacle in translating efficacy in research settings into~     effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication~     treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD~     are multi-dimensional, and it has been suggested that a multifaceted intervention will be~     more effective. The study is aimed to assess the effectiveness of a multifaceted~     intervention on enhancing medications adherence in patients with bipolar disorders.~   "
62296|NCT02241850|"~     The objective of the study is to investigate the effect of high intensity training on~     maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.~   "
62297|NCT02241837|"~     The primary objective is to assess the longterm safety of the CardioKinetix Parachute~     Implant and Delivery System in the partitioning of the left ventricle in patients with heart~     failure due to ischemic heart disease. This sub-study has the additional assessment of~     improvement in Pressure Volume Loop and corresponding MSCT to allow improved monitoring of~     heart improvement after therapy. The PV Loop Substudy studies he effects of the Parachute~     Implant on pressure and volume as functional parameters of the Left Ventricle.~   "
62298|NCT02241824|"~     Rationale~        -  Statement of the Problem. Low back pain is a significant societal problem in the United~          States, affecting approximately one-fourth of all Americans at any given time.~          Non-pharmacological therapies have not been well studied although preliminary evidence~          shows the utilization of bracing may be beneficial in reducing pain and medication~          usage.~        -  Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic~          lumbar brace may decrease opioid use in chronic low back pain patients on a stable~          opioid regimen. The investigators propose to conduct a randomized controlled study to~          test our hypothesis.~        -  Specific Objectives.~      AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable~     opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace,~     elastic abdominal binder (standard care), and no brace (control).~      AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life,~     and functional capacity.~      Long Term aims: To decrease patient's chronic pain level, improve overall daily function,~     decrease overall opioid intake and improve quality of life.~   "
62299|NCT02241811|"~     Chronic foot wounds which is very difficult to treat are common especially in diabetic and~     peripheral arterial or venous insufficiency patients. This research is aim to observe the~     foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.~   "
62300|NCT02241798|"~     The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and~     carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit~     (EMU). The investigators hypothesize that providing oxygen prior to seizures will help~     eliminate the drops in changes seen during seizures, such as the drop in oxygen saturation~     and increase in carbon dioxide levels.~      Research will be done on patients that are admitted to the EMU specifically to have seizures~     occur and to be recorded on video electroencephalography (vEEG), and the only research~     intervention will be the use of oxygen prior to some of the seizures.~      The importance of this research relates to the phenomenon of sudden unexplained death in~     epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found~     dead by their families in the morning, without a clear cause for death. The risk of SUDEP is~     as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple~     mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation~     during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to~     decrease significantly in 25-50% of patients during or shortly after a seizure while being~     monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger~     a cascade of events from which the body may not be able to recover, leading to SUDEP. In~     animal models, providing oxygen prior to seizures occurring has been shown to eliminate~     oxygen desaturation, but more importantly eliminate mortality in animals prone to death due~     to seizures.~      Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it~     reduces the risk of oxygen desaturation during the apneic period of the procedure. On room~     air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes~     following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to~     oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs~     from which transfer to the bloodstream can continue despite the lack of ventilation. The~     apneic episode during seizures should benefit from the same principle.~      The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better~     characterize seizures, to identify the main seizure focus. In addition to standard EEG with~     electrodes on the scalp, some patients require invasive localization of the epileptic focus~     by surgically placing electrodes within the skull (often referred to as GRID patients) on or~     within the brain, with the goal of being able to resect the area that is causing seizures.~     To identify where seizure originate electrically, it requires that seizures occur during the~     vEEG procedure. To provoke seizures, medications are typically lowered, and both partial~     seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will~     occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex~     partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use~     oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the~     investigators also have the capability for both for clinical usage.~      Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs~     following seizures as part of the post-ictal nursing care, though there is no outcome data~     to support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of~     oxygen desaturations clinically, as seen in animal models, and this is the goal of this~     research project.~   "
62301|NCT02241785|"~     The primary objective of the study is to determine the efficacy of natalizumab (Tysabri,~     BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed~     Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by~     the proportion of participants with no evidence of disease activity (NEDA) at Year 1. The~     secondary objectives in this study population are: Change in total T1 hypointense and total~     T2 hyperintense lesion volume; Proportion of participants with NEDA at Year 2; Evaluation of~     the impact of natalizumab on annualized relapse rate (ARR); and Change in Multiple Sclerosis~     Impact Scale-29 (MSIS-29) physical impact score.~   "
62302|NCT02241772|"~     A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a)~     levels.~   "
62303|NCT02241759|"~     A study in healthy males and females to see if a high single dose of TA-8995 has an effect~     on the ECG QTcF interval.~   "
62304|NCT02241746|"~     The purpose of this study is:~        -  to diagnose malnutrition in Chinese hospitalized patients with four nutritional~          screening tools: mini-nutritional assessment - short form, subjective global~          assessment, malnutrition universal screening tool and nutritional risk screening 2002.~        -  to optimize the usage of nutritional screening tools based on data-mining methods.~   "
62815|NCT02235051|"~     This randomized pilot trial studies how well an exercise intervention works in preventing~     breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise~     may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to~     respond to inflammation more proficiently, helping to prevent primary and recurrent breast~     cancer.~   "
62305|NCT02241733|"~     People with moderate to severe COPD trap air in their lungs. This lessens their ability to~     exercise. The investigators developed a computerized breathing retraining program to help~     patients empty their lungs during exercise. The investigators believe that learning to~     control breathing will help patients be more active. The purpose of this study is to test~     the effects of using breathing retraining (intervention group) versus no breathing~     retraining (control group) as part of a 12-week exercise program. The investigators are~     examining the long term effects of this training on exercise capacity and the ability to~     empty ones lungs during exercise. Patients will participate in a 12-week exercise program,~     with or without breathing retraining. They will then participate in a 42 week adherence~     program to maintain physical activity. Patient testing will be competed at baseline, 12~     weeks, 6 months and 1 year. 250 patients with moderate to severe COPD will be enrolled.~   "
62306|NCT02241720|"~     Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced~     Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach~   "
62307|NCT02241707|"~     In this proposal, the investigators seek to determine whether a reduced compression after~     endovenous ablation procedure in treating superficial venous insufficiency affects the~     outcomes. This study involves only the use of the compression stocking post endovenous~     ablation procedure and everything else is standard according to current guidelines.~      The investigators general strategy will be to determine the role of a minimal post-operative~     compression and the status of patient satisfaction including (1) Success closure rate of the~     treated vein. (2) Less pain; (3) Easier accepted by the patients.~   "
62308|NCT02241694|"~     This survey is conducted in South America. The purpose is to identify the key psychosocial~     issues affecting patients with haemophilia.~   "
62309|NCT02241681|"~     Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to~     decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their~     metabolites have not been explored in details.~      This is an exploratory study aiming at determining the plasma level of MCT and their~     metabolites after oral intake of Peptamen.~   "
62310|NCT02241668|"~     The goal of this clinical research study is to learn if using a new imaging solution,~     3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help~     doctors determine if your brain lesion is from the tumor returning or the effects of~     previous treatments.~      The results of this imaging scan (called an FLT PET scan) will be compared to the results of~     a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have~     outside of this study.~   "
62311|NCT02241655|"~     This study aims to determine whether, compared with usual anesthetic care, an~     electroencephalography-guided anesthesia protocol is effective at preventing postoperative~     delirium and its downstream effects, and improving postoperative patient reported~     health-related quality of life.~   "
62312|NCT02241642|"~     The purpose of this Clinical Investigation is to validate that the clinical use of the~     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm~     its performance to percutaneously close femoral arterial puncture sites in the range of~     18-24 F, post endovascular procedures.~      This is a non-inferiority study based on safety. Safety will be assessed by incidence and~     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to~     3 months from implantation is no worse than those associated with cut-down and sutured~     close.~   "
62313|NCT02241629|"~     A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical~     superiority study.~   "
62314|NCT02241616|"~     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B~     Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition~     of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis~     and liver cirrhosis due to HBV, however some patients keep existence or development although~     HBV DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required~     the anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix,~     especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis.~     Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and~     have a good action against liver fibrosis in patients with chronic hepatitis B. However,~     there are no high quality clinical evidences which can demonstrate if the combination of~     anti-viral and anti-fibrotic therapy can improve the reversion of refractory liver fibrosis~     in liver cirrhosis due to HBV.~      The primary objective of this study is to establish the safety and efficacy of the~     combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in~     liver cirrhosis due to HBV.~   "
62315|NCT02241603|"~     Obesity is a common problem in the Veteran population as at least 1 in 3 Veterans are obese.~     When obese people eat food they have less response in areas of the brain that sense pleasure~     (reward). Decreased pleasure response to food predicts future weight gain. It is not known~     if this poor brain response is reversible or why obese people's brains respond this way.~     Insulin in the brain regulates the brain's sensing of pleasure. As people gain weight the~     function of insulin becomes impaired. The investigators will study if impaired function of~     insulin is related to a poor brain response to food and if this brain response predicts~     voluntary intake of food and response to a diet. The investigators will also study if~     improving the function of insulin with weight loss improves the brain response. These~     studies will improve the understanding as to why weight loss is difficult and inform us if~     improving insulin signaling is a potential way to treat obesity.~   "
62325|NCT02241473|"~     By analyzing energetic and biomechanical basis of walking, and the subsequent changes~     induced by hypoxic vs normoxic training in obese individuals, it may optimize the use of~     walking in hypoxia to gain perspective for exercise prescription to set up training programs~     that aim to induce negative energy balance and to deal with weight management. However to~     the investigators knowledge, the analysis of changes in mechanics, energetics and efficiency~     of walking after continuous hypoxic training (CHT) has not been performed yet.~      The aims of the present study were:~        1. Comparing the changes in body composition between continuous hypoxic training (CHT) and~          similar training in normoxia; e.g. continuous normoxic training (CNT) in obese~          subjects.~        2. Comparing the metabolic and energetics adaptations to CHT vs CNT.~        3. Finally, comparing the associated body‐loss induced gait modification since walking~          intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT.~   "
62316|NCT02241590|"~     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B~     Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition~     of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and~     liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of~     hepatic extracellular matrix is still required and hopefully improve the efficacy of~     anti-virals for liver fibrotic patients with HBV, especially is necessary for in the~     patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to~     enhance the degradation of collagens in fibrotic liver and have a good action against liver~     fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical~     evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy~     can improve the reversion of liver cirrhosis due to HBV.~      The primary objective of this study is to establish the safety and efficacy of the~     combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients~     with liver cirrhosis due to HBV.~   "
62317|NCT02241577|"~     This study will compare surgical and non surgical treatments of peri-implantitis.~     Peri-implantitis is an inflammation around dental implants that can lead to the loss of the~     implant over time if no treatment is established. The signs of peri-implantitis included~     bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients~     presenting with these characteristics will be included at random to one of the treatment~     groups. Those allocated to the non-surgical group will received implant cleansing after~     local anesthesia using adequate instruments. In the surgical group, patients will be~     submitted to a surgical procedure around the implant for visualization and cleansing also~     after local anesthesia. All patients will be followed over a 12-month period. The hypothesis~     is that surgical treatment is better than non-surgical treatment regarding clinical,~     radiographic, microbiological, and immunological.characteristics.~   "
62318|NCT02241564|"~     The aim of the project is to improve the overall treatment and outcome of renal, pancreas or~     liver transplanted patients who have encountered a malignancy by a structured treatment~     program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive~     treatment, follow-up and evaluation of the program.~   "
62319|NCT02241551|"~     This is a prospective, randomized phase II trial. Patients diagnosed with borderline~     resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms,~     either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the~     gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be~     restaged with CT scans and if they remain borderline resectable or have improvement of their~     disease They will then proceed to SBRT followed by surgical resection.~   "
62320|NCT02241538|"~     Low back pain is a major cause of disability and absenteeism and the supervised exercise is~     a recommended treatment by the guidelines and has been cost-effective. Currently, the~     Pilates method has shown to be effective in improving pain and disability in patients with~     chronic low back pain (CLBP). However, there is still no evidence about the ideal number of~     sessions for the treatment and the interval between sessions to achieve better efficacy of~     this method for these patients. Thus, the aim of this study is to investigate the~     effectiveness of the Pilates method with different weekly frequency of sessions in the~     treatment of patients with nonspecific CLBP. Investigators will assess 296 patients of both~     genders, with nonspecific CLBP lasting more than three months and aged between 18 and 80~     years. Participants will be randomly divided into four groups (n = 74 patients per group):~     Control Group will receive an educational booklet and no additional exercise, Pilates 1~     Group will receive a program of exercises based on Pilates method once a week for six weeks,~     Pilates 2 Group will receive the same program of exercises twice a week for six weeks and~     Pilates 3 Group will receive the same program of exercises three times a week for six weeks.~     The outcomes overall disability (Roland Morris Disability questionnaire), specific~     disability (Patient-Specific Functional scale), kinesiophobia (Tampa scale for~     kinesiophobia), pain intensity (Pain Numerical Rating scale) and global perceived effect~     (Global Perceived Effect scale) will be assessed by a blinded assessor before, six weeks,~     six and 12 months after randomization. Investigators expect that the largest number of~     weekly sessions of Pilates method may influence the results in all analyzes (short, medium~     and long term), since there is a relationship between frequency of exercises and effect size~     of the treatment.~   "
62321|NCT02241525|"~     Examine the feasibility and efficacy of individually optimized uniform contrast enhancement~     in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.~   "
62322|NCT02241512|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique~     utilized to diagnose and treat pathologic conditions involving the ducts draining the liver~     and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP~     and occurs in approximately 11% of children undergoing the procedure. By definition it leads~     to prolongation of hospital stay or delays in care and rarely can result in long-term~     morbidity or even death. Recent adult trials have demonstrated prevention of PEP with~     administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies~     have been performed in children thus no gold standard or even commonly accepted method of~     preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has~     distinct advantages over rectally administered NSAIDs in the pediatric population in that it~     would allow for more consistent weight based dosing and would have more predictable~     absorption compared to suppository. Thus, this project proposes a pilot study evaluating the~     effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of~     the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to~     placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at~     Children's Medical Center Dallas over a two-year period. The primary outcome measurement~     will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain~     scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time~     of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.~   "
62323|NCT02241499|"~     In this trial, patients with histologically proven adenocarcinoma of the esophagus or~     esophagogastric junction noneligible for surgery or chemoradiation with curative intent will~     be included. Primary objective is to determine the rate of improvement in dysphagia after~     palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy~     consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is~     evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is~     considered to be an improvement.~   "
62324|NCT02241486|"~     The purpose of this study is to examine the efficacy and safety of sublingual fentany spray~     (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn~     injury. It will be compared with a standard treatment regimen of oral morphine. The~     hypothesis is that the fentanyl spray will be more effective for the treatment of procedural~     pain in patients with burn injury.~   "
62326|NCT02241460|"~     The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine~     Spray compared with placebo in patients with premature ejaculation.~   "
62327|NCT02241447|"~     The purpose of this study is to narrow the gap between patients being diagnosed with severe~     aortic stenosis and those being appropriately monitored and treated. For this purpose a~     prospective survey of current practice (3 months) will be conducted followed by a six month~     period of intervention during which a variety of quality improvements measures will be~     implemented. There will then be a 3 month follow-up period during which the legacy of this~     initiative will be monitored during which no intervention will be carried out.~   "
62328|NCT02241434|"~     The purpose of this study was to study the effect of stem cell therapy in patients with~     Duchenne Muscular Dystrophy.~   "
62329|NCT02241421|"~     BACKGROUND: The relation between gut microbiota and obesity originates from animal studies,~     showing that the change of gut microbiota can induce changes in both insulin resistance and~     body composition. In addition, these studies have shown changes in gut permeability inducing~     a pro-inflammatory state, changes in adipose tissue function and inflammation, effects on~     energy harvesting and metabolism, skeletal muscle fatty acid partitioning and fat oxidation.~     Human data is lacking, although several studies suggested that the composition of the gut~     microbiota differs between lean and obese, and between diabetic and non-diabetic~     individuals.~      OBJECTIVE: To provide insight in the physiological significance and underlying mechanisms~     involved in the relation between gut microbiota, energy balance and insulin sensitivity in~     overweight men with impaired glucose homeostasis.~   "
62330|NCT02241408|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on joint pain and functionality in people with Osteoarthritis (OA). SVF contains~     components with regenerative properties, including stem cells that have shown promise for~     ameliorating specific disease conditions. This study is designed to evaluate joint pain and~     functionality changes in individuals with OA for up to 12 months following SVF treatment.~   "
62331|NCT02241395|"~     The purpose of this study was to study the effect of autologous bone marrow mononuclear~     cells on common symptoms of cerebral palsy patients.~   "
62332|NCT02241382|"~     Implantation of internal defibrillators, capable of monitoring the heart and shocking life~     threatening arrhythmias back to normal rhythm, for patients with severe heart failure~     increases the probability of survival. Arrhythmias of the atria of the heart are common in~     these patients. Administering a direct current electrical shock under anesthesia~     (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance.~     Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was~     demonstrated in several studies. Safety of internal cardioversion (shocking the heart back~     into normal rhythm via the implanted defibrillator) was described in several smaller trials.~      Performing external instead of internal cardioversion in patients with implanted ICDs is~     more feasible for most hospitals, as CV can be performed without a programming computer and~     an additional specialist present, e.g. on the intensive care ward, and device interrogation~     can be done after CV at the remote ICD/pacemaker clinic.~      No scientific data on safety and efficacy endpoints comparing internal vs external CV is~     currently available. The aim of the study is to compare external vs internal electrical~     cardioversion for atrial arrhythmias and establish a safety and efficacy profile for~     external and internal cardioversion in large cohort of ICD patients.~   "
62333|NCT02241369|"~     This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity~     of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation~     to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.~   "
62334|NCT02241356|"~     Visual acuity at near improves in children with Down syndrome using bifocals~   "
62335|NCT02241343|"~     Problems affecting the veins in the legs can cause discomfort and swelling. We want to see~     how artificially and reversibly blocking the leg veins affects swelling in the lower limb.~   "
62336|NCT02241330|"~     The objective of this research is to test the efficacy of Zn biofortified wheat in~     increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized~     controlled trial.~   "
62337|NCT02241317|"~     Development of a training concept for health care professionals (nursing and medical staff),~     according to the current guidelines on treatment of in-patients with Diabetes. Primary~     endpoint is the change in hypoglycaemia rates comparing data before and after the training.~     Hereby we can derive the effects of staff training on the quality of health care in this~     patient population.~   "
62338|NCT02241304|"~     TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular~     monitoring system intended for daily clinical use. The primary aim of this clinical~     investigation is to examine the applicability (ease of use, equipment need, etc.),~     repeatability (precision or internal consistency) and performance (signal quality, accuracy~     of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph~     device in patients undergoing elective surgeries requiring neuromuscular blockade.~   "
62339|NCT02241291|"~     The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural~     data as well as to assess the clinical outcomes of all patients undergoing percutaneous~     coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or~     without stent implantation will be prospectively registered. Device use is according to the~     decision of the treating physician and independent of this registry. At hospital discharge~     and one year, the following outcomes will be assessed: death, cardiac death, myocardial~     infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding,~     renal failure and vascular complications.~   "
62355|NCT02241083|"~     Vasopressors may be needed after head and neck microvascular reconstructions to maintain~     sufficient mean arterial pressure. This is crucial for the flap survival. The study~     hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap~     tissue oxygen level and microdialysate metabolites.~   "
62356|NCT02241070|"~     The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas~     a workplace health promotion program on psychological distress, prolonged fatigue, job~     strain (job control and job demand), and perceived stress and to explore the influences of~     personal characteristics (including gender, age, education, and occupation) on the outcomes~     of the intervention with time.~   "
62816|NCT02235038|"~     This study will evaluate a potential physiologic mechanism underlying the effects of dietary~     composition on control of body weight~   "
62340|NCT02241278|"~     The analgesic properties of ketamine are associated with its non-competitive antagonism of~     the N-methyl-D-aspartate receptor; these receptors exhibit an excitatory function on pain~     transmission and this binding seems to inhibit or reverse the central sensitization of pain.~     In the literature, the value of this anesthetic for preemptive analgesia in the control of~     postoperative pain is uncertain. The objective of this study was to ascertain whether~     preoperative low-dose ketamine reduces postoperative pain and morphine consumption in adults~     undergoing colon surgery.~      In a double-blind, randomized trial, 48 patients were studied. Patients in the ketamine~     group received 0.5 mg/kg intravenous ketamine before surgical incision, while the control~     group received normal saline. The postoperative analgesia was achieved with a continuous~     infusion of morphine at 0.015 mg∙kgˉ¹∙hˉ¹ with the possibility of 0.02 mg/kg bolus every 10~     min. Pain was assessed using the Visual Analog Scale (VAS), morphine consumption, and~     hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. We quantified~     times to rescue analgesic (Paracetamol), adverse effects and patient satisfaction.~   "
62341|NCT02241265|"~     The investigators hypothesis is that there will be improvement in FEV1 in patients with~     severe asthma.~   "
62342|NCT02241252|"~     This study will validate the recording accuracy of a specific electrical interval of the~     heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead~     electrocardiogram (ECG). These measurements will occur in hospitalized patients that are~     starting either sotalol or dofetilide, since both of these medications can prolong the QT~     interval.~   "
62343|NCT02241239|"~     There are many risk prediction models. And their estimates are different. This study aimed~     to investigate the differences between the estimates of Fuwai and Reynolds risk model in~     Chinese, and investigate the reason for the differences.~   "
62344|NCT02241226|"~     It is becoming increasingly recognized in the literature that ancient practices for~     wellbeing, including meditation, yoga, and specific herbs, can improve health and promote~     longevity. While studies have documented such effects for a variety of individual practices~     for wellbeing, few studies have taken a more whole systems approach that is simultaneously~     inclusive of numerous practices. This intervention study, the Self-Directed Biological~     Transformation Initiative, will examine the effects of a comprehensive whole systems~     approach to wellbeing on key biochemical, physiological, and psychosocial endpoints.~     Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing~     will be compared to individuals not taking the program.~   "
62345|NCT02241213|"~     Aphasia is one of the most disabling complications in language production in patients with~     left hemisphere stroke. About 19% of patients who experience aphasia may have a~     spontaneously recovery after several weeks or months. Some studies have reported that~     repetitive low frequency Transcranial Magnetic Stimulation (TMS-r) in patients with ischemic~     stroke generates left modulation of cortical excitability by facilitating and promoting~     functional reorganization and recovery of language production. In spite of this, most of the~     studies in patients with post-stroke aphasia, are small cases series without controls that~     correspond to a descriptive design and does not perform long-term follow up. Currently the~     population is heterogeneous respect to etiology, type of stroke and aphasia severity; also~     several authors have concluded that the exact location of the site, would be possible~     through the neuronavigation technique, to obtain better results.~      OVERALL OBJECTIVE Determine the efficacy of repetitive low-frequency TMS on oral language~     recovery in post-ischemic stroke patients with non-fluent aphasia~      ESPECIFIC OBJETIVES~        -  Estimate the effect of repetitiveTMS treatment on right Lowe Frontal Gyrus (GFI), in~          the evolution of the neuropsychological language test results in patients with~          non-fluent aphasia, compared to placebo.~        -  Describe the behavior of depression and anxiety levels in both treatment groups (active~          and placebo), through Zung anxiety and depression test, to establish their correlation~          with production testing language.~        -  Evaluate the effect of repetitiveTMS technique compared to placebo, on the overall~          functionality of the subject through Barthel scale.~        -  Describe the impact of language behavior on the quality of life of patients treated~          with placebo and active EMT, assessed by the EuroQol test.~      METHODOLOGY A placebo double blind controlled and randomize trial, to evaluate the efficacy~     of low frequency EMT-r in language recovery in 100 patients with first ischemic stroke event~     among the first 4-8 months postinfarction and non-fluent aphasia. The patient will agree and~     will sign the informed consent, in order to application aphasia diagnosis Boston test,~     Edinburgh test, Barthel scale, Zung anxiety and depression test, and EuroQol scale,~     Neuropsi. Subsequently the subjects will be randomizate to any of two arms of the study. A~     week before the start of the stimulation sessions, the following tests will be applied to~     assess language production: Boston Test and Verbal Fluency (FAS). Each patient will have a~     daily session EMT-r low-frequency active or inactive coil with a biphasic stimulator pulses~     applied for ten days in two weeks on the triangular area - homologous to injury Lower Front~     Gyrus (LFG), (right brain hemisphere). Complete the treatment schedule of two weeks, the~     language production will be evaluate again, and also scales as Barthel an Rankin-m, Zung~     anxiety and depression and EuroQol. This monitoring will be achieved in five stages: after~     one week, one month, 4 months, 8 months and 12 months post-stimulation, with the intention~     of determining the duration and effectiveness effects in language production of the EMT-r.~   "
62346|NCT02241200|"~     The main purpose of the study is to determine whether the test product and the reference~     product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a~     single intravenous dose and as a single subcutaneous dose of each of the formulations. The~     study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.~   "
62347|NCT02241187|"~     This study has several purposes. DCE-MRI will be used to image the tumor. Safety of~     cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be~     studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery~     will be studied. Also, the effects of PEGPH20 on tumors will be studied.~   "
62348|NCT02241174|"~     This study will determine the safety and efficacy of diluted bleach bath solution as final~     rinse on the reduction of Staphylococcus aureus colonization among children and adult~     Filipinos with mild to moderate atopic dermatitis..~   "
62349|NCT02241161|"~     Aim of the study was to evaluate the soothing and re-epithelizing activity of a single~     application of topical products on experimentally induced erythema by skin stripping on the~     forearm (volar surface) of 20 healthy volunteers. In particular the activity of the~     following three cosmetic products and the relative combinations (cream and serum) were~     assessed: rejuvenating cream, rejuvenating serum, antioxidant serum~   "
62350|NCT02241148|"~     The investigators will include patients attending outpatient clinic in the area of~     Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral~     Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting~     unilateral PFPS with six months of evolution, presenting anterior or retro knee pain that~     presents itself when undergoing two or more of the following activities: squatting, running,~     kneeling, jumping, or climbing stairs; physically active patients, with at least thirty~     minutes of physical activity at least three times per week. Exclusion criteria include~     patients with previous knee surgeries, chronic pain with more than one year of evolution,~     pregnancy or suspected pregnancy, application of intra-articular steroids in the three~     months prior to their evaluation, patients with meniscal injuries, ligament or~     intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid~     arthritis, OA of the knee, hip or ankle, history of dislocation or subluxation of patella,~     Osgood Schlatter syndrome and patellar tendinitis or quadriceps.~      The investigators will divide patients into two groups. The control group will receive~     treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and~     stretches at home intended for the strengthening of quadriceps, abductors and internal~     rotators of the hip for the duration of six weeks. The experimental treatment group will~     receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ®~     Kinesio taping on the affected knee. Both groups will be evaluated by an external~     consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the~     WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the~     beginning, third and sixth week. The patients in the experimental group will be quoted each~     week to change the tape. The control group will be quoted at the beginning, at three weeks~     and after six weeks. During the first appointment we will take patients anthropometric~     measurements (weight, height, BMI) as well as general information. Radiographic studies~     (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out~     other diseases and see the degree of contact of the patella on the patellofemoral joint. All~     patients will receive an explanation about their illness, and a booklet with the required~     exercises as well as their frequency.~      For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips~     that were placed inferior to the head with no pressure applied, then two bands are placed at~     the ends of the tape and crossed on the edges of the patella and ending at the thigh to~     finish applying moderate tension to place them, then two strips were placed at each end of~     the edges of the first and second tape without applying pressure. The tapes can last up to~     five days on the extremities while maintaining their purpose, patients included in this~     group will be summoned each week to remove the tapes and place new ones.~   "
62351|NCT02241135|"~     The purpose of this trial is to assess the safety and immunogenicity of an investigational~     RNActive® rabies vaccine (CV7201) in healthy adults.~   "
62352|NCT02241122|"~     Prostate cancer has been the most common neoplastic disease in men in Finland over the last~     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate~     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer~     detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography~     (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually~     performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of~     complications, there is an increasing interest in developing more accurate non-invasive~     imaging modalities.~      This prospective multi-institutional study will enroll 400 men with clinical suspicion of~     prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital~     rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted~     imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to~     non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided~     biopsy based on MRI findings will be performed in addition to routine twelve core TRUS~     biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from~     fresh biopsy sample will be collected and correlated with the presence or absence of~     prostate cancer.~   "
62353|NCT02241109|"~     Aortic stenosis is the most common valvular heart disease and an important public-health~     problem. Surgical or interventional aortic valve replacement are based on symptoms and~     measures of valvular and ventricular function using echocardiography.There is no uniform~     pattern of progression. Instead, marked differences not only between individuals, but also~     during the time course of the disease can be observed.~      Several prospective studies have been performed to enhance the predictability of disease~     behavior. Individually it is still prone to large errors and hard to predict aortic stenosis~     progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is~     desirable to find a strong predictor of rapid disease progression. This would allow~     anticipating cardiovascular deterioration by identifying individuals at particular risk.~      Study Hypothesis~      In patients with aortic sclerosis, increased serum calcification propensity, as measured by~     the T50-Test, is related to the amount of stenosis progression in one year.~   "
62354|NCT02241096|"~     To determine safe concentration level of lidocaine infusion in children.~   "
62358|NCT02241044|"~     Background:~      A second endoscopic method added to injection therapy is recommended for high-risk bleeding~     peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments,~     whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely~     investigated.~      Aim:~      This study was designed to know whether additional APC treatment could influence the~     hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding~     ulcers.~      Methods:~      From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were~     admitted to our hospital. They prospectively randomly underwent either APC therapy plus~     distilled water injection or distilled water injection alone. Pantoprazole infusion was~     conducted during the fasting period after endoscopy and orally for 8 weeks to encourage~     ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy.~     Patients who did not benefit from retreatment underwent emergency surgery or transarterial~     embolization (TAE).~   "
62359|NCT02241031|"~     The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic~     progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by~     chemotherapy in patients with acute leukemia (AL).~   "
62360|NCT02241018|"~     The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and~     calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients~     with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic~     hematopoietic stem cell transplantation.~   "
62361|NCT02241005|"~     Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality~     and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT).~     These infections are often caused by a patient's own microbial flora. Hence reduction of~     microbes in the skin could lessen the risk of contamination of central venous catheters,~     Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise~     of skin integrity.~      Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing~     agent that combines a specialized surfactant with skin healthy ingredients, including aloe,~     allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used~     on all parts of the body including burns, abraded skin, and on patients with skin~     graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial~     resistance. Microbiologic studies have shown several log fold reduction of bacteria~     including vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and~     activity against Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile,~     Candida albicans, and viruses including influenza A and Herpes Simplex. There is no data~     regarding the use of Theraworx™ (experimental) bath wipes in children or the HSCT~     population.~      Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with~     experimental bath wipes will be well tolerated and associated with reduction in microbial~     skin colonization in this population.~   "
62362|NCT02240992|"~     The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with~     or without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells~     (PBSC) in treating patients experiencing poor graft function or delayed platelet engraftment~     after allogeneic hematopoietic stem cell transplantation.~   "
62363|NCT02240979|"~     The purpose of the study is to evaluate a new way to examine cardiac function, using~     software developed at Caltech. The experimental device is software loaded on an iPhone. The~     iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the~     neck where the carotid pulse can be felt. In this study the information collected from the~     iPhone app is compared to cardiac function data obtained from the current gold standard for~     measuring cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from~     cardiologists will also generally have echocardiography information available for comparison~     with the iPhone app. For the study, subjects will have completely non-invasive studies done~     in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)~     arteries), tonometry (another non-invasive method using a modified stethoscope), standard~     pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete~     study will be done about 6 months after the first. The complete study session takes about~     1.5 hours.~   "
62364|NCT02240966|"~     The purpose of this study is to investigate the prevalence of signs and symptoms of~     hypogonadism in three groups of testicular cancer survivors.~   "
62365|NCT02240953|"~     Prosthetic valve thrombosis is a serious complication with high mortality and morbidity.~     However, the best anticoagulant treatment strategies for patients with prosthetic heart~     valve thrombosis have not been fully known. In this study the investigators wanted to~     identify the most effective and safe regimen among different anticoagulant regimens.~   "
62366|NCT02240940|"~     The design of this study is a multi-center, prospective, single-arm clinical trial to~     evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning~     system. The purpose of this trial is to use the Parachute percutaneous left ventricular~     partitioning system to isolate the malfunctioning portion of the left ventricle in patients~     with symptoms of heart failure due to ischemic heart disease and provide the data required~     to gain Chinese regulatory approval.~   "
62367|NCT02240927|"~     Pregnancy is associated with increased risk of thrombosis among women with mechanical~     prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant~     patients with prosthetic heart valves have been controversial. In this study the~     investigators wanted to identify the most effective and safe regimen among different~     anticoagulant regimens.~   "
62368|NCT02240914|"~     -  Determine the sensitivity, specificity and accuracy of vascular ultrasound, using~          direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous~          segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering~          the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.~        -  Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in~          the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).~   "
62381|NCT02240745|"~     The investigators are going to recruit patients who have a scheduled elective coronary~     angiography and going to do a dobutamin stress echography (DSE) before the coronary~     examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE,~     incl ventriculography. In the interventional part (coronary angiography), they will measure~     each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.~   "
62369|NCT02240901|"~     Perioperative airway management is a top priority of anesthesiologists in daily work, and~     endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic~     seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related~     complications such as concomitant hemodynamic responses, damage to the oropharyngeal~     structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the~     anesthesia management brings new choice with invasive, lighter cardiovascular reaction and~     many other advantages, particularly suited to short and minimally invasive surgery. But LMA~     increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted~     in intolerance in high airway pressure, especially in elderly patients with increased lung~     compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the~     occurrence of postoperative sore throat and hoarse.~      To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety~     of LMA in elderly patients. The investigators protocol will focus on the incidence of~     postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly~     patients.~   "
62370|NCT02240888|"~     The overall objective of this project is to study the influence of modern anti-inflammatory~     treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited~     by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In~     addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in~     immunosuppressed patients with IRD, impact on existing rheumatic disease, possible~     association with onset of new autoimmune diseases, long-term immunity following pneumococcal~     vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related~     serious infections. Results from this study are expected to bridge the existing knowledge~     gap and contribute to body of evidence needed for recommendations and implementation of~     vaccination program in IRD patients.~   "
62371|NCT02240875|"~     The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different~     doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to~     assess the safety of the vaccines and the extent of the immune response in healthy~     volunteers. The investigators will do this by giving volunteers a either one or two~     vaccinations, doing blood and saliva tests and collecting information about any symptoms~     that occur after vaccination. This is the first trial to use either of these vaccines in~     humans. We plan to recruit a total of 92 volunteers to be vaccinated.~   "
62372|NCT02240862|"~     The objective of C2R is to promote the rapid initiation and completion of enrollment in the~     CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe~     symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid~     artery stenting (CAS) performed by experienced and skilled interventionists.~     Interventionists' eligibility will be determined by a multi-specialty Interventional~     Management Committee (IMC). Patient eligibility will include patients with standard or~     high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for~     the occurrence of post-procedural complications. The primary safety and quality endpoint~     will be the occurrence of any stroke or death within the 30-day period following the~     stenting procedure. The safety and quality results from C2R will guide selection of~     interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into~     C2R will begin in 2015 and continue until publication of the primary results of the~     randomized trial.~   "
62373|NCT02240849|"~     The purpose of this study is to investigate the effects of functional cervical pillow on~     inpatients with neck discomfort.~   "
62374|NCT02240836|"~     The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise~     program comprised of strength and endurance training among newly diagnosed breast cancer~     patients undergoing adjuvant therapy, will influence factors associated metabolic profile,~     tumor growth and cardiopulmonary function. Secondary aims are to determine whether the 12~     month exercise program will influence disease-free survival, overall mortality and breast~     cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors~     will be assessed and evaluated.~   "
62375|NCT02240823|"~     Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.~     Studies have shown a high number needed to treat for each saved prostate cancer related~     death. Since the treatments incur many complications, there is a need to address these.~     After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of~     people's identity, self-esteem and quality of life. Stem cells have generated a large amount~     of promising data suggesting that stem cells can alleviate erectile dysfunction, by~     regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.~   "
62376|NCT02240810|"~     To compile acute procedural performance and clinical outcomes data for the Promus PREMIER~     everolimus-eluting coronary stent system in understudied/underserved patient populations~     including women and minorities.~   "
62377|NCT02240797|"~     The purpose of this study is to use positron emission tomography (PET) imaging and magnetic~     resonance imaging (MRI) to understand the brain function of individuals with anorexia~     nervosa and healthy controls.~   "
62378|NCT02240784|"~     The purpose of this study is to characterize the natural history and clinical management of~     Acute Hepatic Porphyria (AHP) patients with recurring attacks.~   "
62379|NCT02240771|"~     In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at~     presentation and hence are unsuitable for the available curative treatment options. In such~     patients the treatment options are mainly palliative. Transarterial chemoembolization~     (TACE), transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only~     available options currently. Many patients have more advanced disease with the involvement~     of branches of portal vein. This further limits the therapeutic options. According to~     Barcelona Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any~     standard form of therapy. TAC and oral chemotherapy has been tried in this group of patients~     by few researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for~     advanced stage (BCLC C) needs to be explored. However, there are no randomized controlled~     trials (RCT's) available.~      TAC is the procedure for treating patients of HCC with portal vein invasion where only the~     chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent~     embolization of the feeding vessels.~      In order to select a modality which would produce better outcomes in advanced HCC patients~     (BCLC C), this study was planned.~   "
62382|NCT02240732|"~     BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England,~     Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a~     surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's~     leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can~     therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative~     tourniquet can therefore help to improve the surgical field of view. Although the majority~     of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number~     are now not pursuing these devices.~      There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet~     is used for TKR surgery. In addition embolic material in the venous system have been~     observed following TKR surgery and have been noted to be present in the right atrium with~     transoesophageal (TOE) echo intra-operatively. , Significant and potentially life~     threatening emboli have been documented to enter the cerebral circulation via pulmonary~     arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The~     clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully~     understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the~     result of emboli formed during a TKR. ,~      AIM~        -  Is there evidence of emboli entering the cerebral circulation following tourniquet~          deflation in TKR surgery?~        -  Is there evidence of MRI detectable brain lesions and or any clinical change in~          cognition compared in patients undergoing TKR surgery with a tourniquet compared to~          those that do not have a tourniquet?~   "
62383|NCT02240719|"~     This phase I trial studies the side effects and the best dose of everolimus when given~     together with bendamustine hydrochloride in treating patients with cancer of the blood~     (hematologic cancer) that has returned after a period of improvement (relapsed) or did not~     get better with a particular treatment (refractory). Everolimus may prevent cancer cells~     from growing by blocking a protein that is needed for cell growth. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving everolimus together with bendamustine hydrochloride may be a~     better treatment for hematologic cancer.~   "
62384|NCT02240706|"~     Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability,~     pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients~     with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia.~     Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared~     to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic~     anemia without a deletion 5q cytogenetic abnormality.~   "
62385|NCT02240693|"~     The study is designed to compare the effects of 4 different doses of orally administered BI~     409306 to placebo in patients with Alzheimers Disease~   "
62386|NCT02240680|"~     To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day~     compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in~     elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient~     glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors~     is also allowed.~      In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when~     added to background basal insulin therapy. The treatment duration of this trial (24 weeks)~     will enable assessment of the clinically relevant endpoint of a decrease in glycosylated~     Haemoglobin, a well-accepted measurement of chronic glycaemic control.~   "
62387|NCT02240667|"~     1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12~     months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for~     definitive treatment discontinuation will be collected. At 6 months, patient adherence will~     be assessed, using the Morisky Score.~   "
62388|NCT02240654|"~     This is a descriptive, observational, multi-country European cross-sectional study of new~     users of dabigatran etexilate that aims to characterise on- and off-label status and other~     medical characteristics at the time of the first captured prescription of dabigatran~     etexilate in each database. The study will be conducted using Cegedim Strategic Database~     (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink~     (CPRD, UK).~   "
62389|NCT02240641|"~     The study aimed at comparing the evolution of renal function in patients showing a~     hypertension treated by various therapeutic strategies.~      Due to the contract research organisation (CRO) decision in September 2000, the database was~     locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to~     stop the study and not proceed to the analysis. Thus, only safety data were processed in the~     safety database.~   "
62390|NCT02240628|"~     The main objective is to evaluate if combining placing the Synera patch and using Propofol~     /Lidocaine mixture will further decrease the pain associated with the IV injection of~     Propofol.~   "
62391|NCT02240615|"~     Prospective, open label, multi-center, non-randomized study designed to collect initial~     clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent~     for use during repair of the lacrimal system in patients with functional or obstructive~     epiphora.~   "
62392|NCT02240602|"~     Postoperative pain control is required after major abdominal surgery, including laparoscopic~     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain~     control mainly in Europe. The aim of this study is to evaluate the optimal dose of~     intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.~   "
62393|NCT02240589|"~     The purpose of this study is to determine if memantine can improve cognitive and~     neuropsychiatric outcomes after severe traumatic brain injury.~   "
62394|NCT02240576|"~     We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the~     history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a~     retrospective analysis of 310 patients with a nasal fracture in the past would be useful to~     investigate the incidence of IR in this cohort afterwards (5-10 y later).~   "
62899|NCT02233959|"~     Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone~     to pediatric and adult patients. The rationale for this study is that palatability is the~     most important determinant of pediatric patient compliance, and therefore, it is critical~     that the Orbis formulation be perceived as significantly more palatable compared to today's~     commercially available products in order to warrant further development of the TP.~   "
62395|NCT02240563|"~     INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired~     hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized,~     placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without~     nodules on ultrasonography study (US) was conducted from March 2006 to March 2009~     (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to~     placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid~     vascularization pattern by US. There was also improvement in the thyroid function and~     reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown~     promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on~     the thyroid parenchyma are unknown. Thus, the objective of this study is to perform~     biochemical tests and thyroid US six years after the clinical trial interventions to~     evaluate levothyroxine dose, serum levels of autoantibodies and, especially, the frequency~     and nature of nodules in the gland and then compare these variables between LLLT and placebo~     groups. METHODS: This study will include the trial participants performed six years before.~     The levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and~     anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US~     will assess the texture (with particular attention to identifying nodules), echogenicity,~     volume, as well as vascularization of the gland. The US nodules features, such as~     dimensions, shape, margins, extracapsular invasion, echogenicity, texture, hypoechoic halo,~     calcification, internal content, vascularization pattern and resistivity index will be~     searched. Regional lymph nodes and other characteristics will be also investigated. The USs~     will be carried out by only one examiner who will be blinded for the previously performed~     intervention (LILT or placebo). The same investigator will execute a fine needle aspiration~     (FNA) of patients with thyroid nodules. The cytological analysis of the material collected~     from the nodules will be undertaken by a pathologist who will be also blinded for the~     treatment assignments. RESULTS: The following variables will be compared between the two~     groups: levothyroxine doses, antithyroid antibodies, US parameters, thyroid nodules (if~     detected) and in this case, the result of their respective FNA.~   "
62396|NCT02240550|"~     This investigation will be a double-armed, randomized (Blinded patients and Blinded~     examiner) prospective study designed to collect perioperative and postoperative data to~     compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.~   "
62397|NCT02240537|"~     The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor~     activity of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels.~     The peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Subjects with~     AML, MM, sMM, or MDS who are off treatment and with stable disease or better, or who are not~     eligible for or refuse allogeneic HSCT are to be enrolled. The study will be conducted at 2~     to 4 study centers in the US.~   "
62398|NCT02240524|"~     The purpose of this study is to study the efficacy of hyperthermic intraperitoneal~     chemotherapy in the treatment of patients with locally advanced gastric cancer after radical~     gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.~   "
62399|NCT02240511|"~     Heart Failure (HF) is a complex syndrome which can include the physiological, neural~     hormonal and metabolic complications known as Cardiac Cachexia (CC). In the development of~     CC there is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and~     6)that cause a decrease of fat free mass and fat mass. These changes in body composition~     might be reversed with a therapeutic combination of resistance exercise and branched chain~     amino acid supplementation (BCAA). Thus the purpose of this study is evaluate changes in~     body composition after a resistance exercise program and BCAA supplementation in patients~     with HF.~   "
62400|NCT02240498|"~     The objectives of this Phase 1 study are to evaluate the safety and feasibility of~     methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess~     drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination~     and imaging and laboratory studies in order to identify adverse events that may be induced~     by MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this~     patient population.~   "
62401|NCT02240485|"~     The aim of the study is to compare marital treatment to individual treatment for~     pathological gambling.~   "
62402|NCT02240472|"~     Since the introduction of sentinel node biopsy in breast cancer, it has become clear that~     its use is reliable and reproducible. Today, it is clinical routine to not remove further~     lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph~     node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also~     routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal~     cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in~     slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been~     shown that a completion axillary clearance (removal of further lymph nodes from the arm pit)~     does not contribute to a better survival. Data from a randomized study indicate that it~     seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes~     with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical~     practice in many countries, however, it is still debated whether it is safe to omit axillary~     clearance in the case of sentinel node macrometastasis due to under-recruitment in the~     aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance~     of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.~      The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2~     sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more~     than a maximum of 2.5% after 5 years.~      This study is a prospective multicenter randomized trial including the majority of centers~     in Sweden treating breast cancer. Planned accrual is 3700 patients.~      Breast cancer patients without signs of axillary nodal involvement will be eligible for~     sentinel node biopsy. Those who are found to have up to two sentinel node containing~     macrometastasis will be informed about this trial Those wishing to participate will be~     randomized to either undergo further axillary surgery (clearance) or not. Outcome measures~     are breast cancer-specific survival, disease-free survival, axillary recurrence rate and~     overall survival.~   "
62403|NCT02240459|"~     The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses~     versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older~     people with overactive bladder and mild cognitive impairment.~   "
62404|NCT02240446|"~     The overarching goal of this project is to expand the traditional expertise in non-invasive~     neuromodulation at the University of Minnesota towards developing novel neuromodulation~     approaches using transcranial direct current stimulation (tDCS) for treating schizophrenia~     patients with medication-resistant auditory hallucinations. The investigators will use tDCS~     to stimulate prefrontal cortex. TDCS is a non-invasive brain stimulation technique that can~     modulate brain connectivity. Non-invasive brain neuromodulation will be combined~     (paired-neuromodulation) with training of a task that requires top-down control of auditory~     processes. Paired-neuromodulation can potentially be used as a therapeutic intervention to~     decrease auditory hallucinations in schizophrenia.~   "
62405|NCT02240433|"~     The main purpose of this study is to evaluate safety and tolerability of LY2157299 when~     combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.~   "
62455|NCT02239770|"~     The objective of this study is to test the effect of a range of doses of a novel nicotine~     film on plasma nicotine levels, expired carbon monoxide and, via a questionnaire, subjective~     ratings of the film and side effects. The nicotine film is not part of standard of care and~     is not available in a non-investigational setting. The investigators hypothesize that plasma~     nicotine levels will be in keeping with those induced by other oral nicotine replacement~     therapies (NRTs) and by the smoking of a cigarette. Thus, the investigators predict that~     random delivery of nicotine via the oral film will be safe and well-tolerated by the human~     subjects.~   "
62406|NCT02240420|"~     The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base~     counseling intervention for young Latino women who are at high risk of diabetes. The~     intervention will focus at the end of pregnancy and the 9 months post-partum period to~     improve education and behavioral counseling on nutrition and other related health topics .~      The following hypotheses will be formally tested:~      Compared with controls at 9 months post-partum:~        1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for~          minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);~        2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;~        3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.~      Women in the STAR-MAMA will have lost more weight than women in the control group.~   "
62407|NCT02240407|"~     A recombinant AAV vector has been generated to carry the codon-optimized acid~     alpha-glucosidase (coGAA) gene expressed from a human desmin enhancer/promoter (DES). The~     proposed clinical trial is a within-participant, double-blind, randomized, phase I~     controlled study evaluating the toxicology, biodistribution and potential activity of~     re-administration of rAAV9-DES-hGAA injected intramuscularly into the TA. Nine participants~     (18 years old or older) Late-Onset Pompe Disease (LOPD) will be included. The goal of the~     immune modulation strategy is to ablate B-cells (Rituximab and Sirolimus) prior to the~     initial exposure to the study agent in one leg and the subsequent exposure of the same~     vector to the contralateral leg after four months. At each study agent dosing, the~     contralateral leg will receive excipient. Patients will act as their own controls. Repeated~     measures, at baseline and during the following 3 months after each injection, will assess~     the safety, biochemical and functional impact of the vector.~   "
62408|NCT02240394|"~     Increased intracranial pressure is a cause of disease progression in patients with brain~     disease, a common cause of poor prognosis. Intracranial pressure monitoring is the~     observation of the disease, treatment, evaluation and important way to improve the~     prognosis. Non-invasive intracranial pressure monitoring can be used to stroke, intracranial~     hemorrhage, brain trauma, encephalitis and other patients. Ophthalmic artery originated from~     the internal carotid artery, the optic canal into the orbit, the entire process can be~     divided into intracranial optic tube segment and orbital segment. investigators' preliminary~     experiments show that when intracranial pressure, intracranial ophthalmic artery segment~     velocity increases with increasing velocity difference orbital segment. Accordingly, the~     investigators speculate, may be judged by the level of intracranial pressure intracranial~     and orbital velocity difference between the ophthalmic artery segment, and accordingly~     calculate the specific values of intracranial pressure. The investigators will collect brain~     trauma surgery, performed invasive intracranial pressure monitoring cases, the use of~     transcranial Doppler ultrasound velocity and different segments of the ophthalmic artery~     pulsatility index, the invasive intracranial pressure and comparing the measured values to~     calculate the the critical value of the ophthalmic artery segment intraorbital and~     intracranial velocity difference when intracranial pressure, thus fitting Based on~     projections of mathematical formulas intracranial pressure. This study will provide a~     non-invasive intracranial pressure monitor new approach.~   "
62409|NCT02240381|"~     This clinical trial studies the physiology and immunology of new-onset post-transplant~     diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose~     tolerance testing (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used~     to define the mechanisms associated with abnormal glucose homeostasis following stem cell~     transplantation. Information from this clinical trial could be used to develop standardized~     screening procedures or to develop optimal treatment strategies for patients developing~     post-transplant diabetes mellitus.~   "
62410|NCT02240368|"~     The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG~     monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo)~     in relationship with the age in the pediatric surgery setting.~      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established~     in adult general anesthesia.~      Their utility is yet undefined in the pediatric population as age seems to affect their~     ability to track the cerebral hypnotic state in children.~   "
62411|NCT02240355|"~     This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study~     will investigate the safety and tolerability of RO6885247 in adult and pediatric patients~     with spinal muscular atrophy (SMA).~   "
62412|NCT02240342|"~     Women delay maternity and, as a consequence, available oocyte number and their quality~     decrease (9-18% of all IVF patients). Different treatment protocols have been developed~     nevertheless none of them optimal: the number of oocytes retrieved depends on the present~     ones. New generation of oocytes and follicles has been defended by some authors and bone~     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals~     able to activate dormant cells and to attract undifferentiated cells from other tissues~     (homing). This phenomenon has been described by our group in other human reproductive~     tissues like endometrium. The purpose of the study is to improve ovarian reserve in~     unfertile women with poor ovarian reserve by means of bone marrow protective capacity.~      Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to~     colonize ovarian niche.~      The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve~     differentiating themselves into germ cells or, more likely, stimulating the niche to~     activate dormant follicles.~   "
62413|NCT02240329|"~     The purpose of this research study is to evaluate coughing in people who have had a brain~     injury. It is hypothesized that individuals who have sustained a brain injury will~     demonstrate differences in cough waveform and respiratory measures compared to individuals~     who have not sustained a brain injury.~   "
62414|NCT02240316|"~     This observational study aims to assess the therapeutic responsiveness of MabThera SC in~     patients with malignant lymphomas under everyday clinical practice conditions. Patients with~     previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously~     untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy~     with MabThera SC according to the assessment of the physician will be prospectively enrolled~     for observation. No study specific measures are required; treatment and documentation will~     be performed according to usual clinical practice.~   "
70176|NCT02138799|"~     This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism~     of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in~     plasma.~   "
62415|NCT02240303|"~     The aim of this project will be to document the central and peripheral mechanisms, which may~     predict clinical pain characteristics and associated physical performance in older adults.~     Although chronic pain is common among older adults, there is limited understanding on the~     processing of pain and the mechanisms by which it affects physical function in these~     individuals. The first aim of this study will be to examine predictors of clinical pain in~     older adults. These will include a comprehensive somatosensory assessment battery including~     mechanical and thermal detection and pain thresholds in older adults with and without~     chronic pain. The investigators will also assess basal cognitive and physical function to~     determine their associations with chronic pain. Finally, brain structure and function will~     be assessed in these older adults with and without pain.~   "
62416|NCT02240290|"~     The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken~     down and eliminated from the body. The compound to be administered will be radiolabeled.~     This enables the investigator to trace the compound in blood, urine, feces, expired air and~     track what happens to it.~   "
62417|NCT02240277|"~     Patients with septic shock may have altered volume of distribution and metabolism of~     antibiotics which are crucial medications for treating infections. The aim of the study is~     to investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used~     antibiotics, in patients with septic shock. The hypothesis is that standard dosing may~     produce insufficient levels of antibiotics in patients with septic shock.~   "
62418|NCT02240264|"~     The brain is primarily developed in the third trimester of pregnancy, but continues maturing~     through the late twenties, especially the prefrontal cortex. Omega-3 long-chain~     polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell~     membranes, influence membrane fluidity and signal transduction, and thus learning, cognition~     and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with~     limitations in these complex brain functions. Previous studies suggested that such functions~     could be improved by increasing LCPUFA. The adolescent brain, however, has been largely~     neglected. This study investigates the effect of one-year daily omega-3 LCPUFA~     supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower~     general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority~     of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake~     of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents~     preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive~     daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be~     adjusted individually to reach a target level of 8-11%. The effects on learning (academic~     achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation,~     goal-orientation, absenteeism), and in a subsample cognitive processes, in particular~     perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months.~     This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a~     safe intervention, on a large variety of complex brain functions.~   "
62419|NCT02240251|"~     This is a prospective chart review to follow our laser-assisted IVC filter retrieval~     patients. We intend to validate existing literature and scientific findings by publishing~     our own clinical experience in difficult IVC filter retrievals.~   "
62420|NCT02240238|"~     In the dose escalation phase (Part 1), this study will determine the dose-limiting~     toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of~     NC 6004 in combination with gemcitabine.~      In the expansion phase of the study (Part 2), study will evaluate the activity of NC-6004 in~     combination with Gemcitabine in patients with first-line Stage IV squamous non-smallcell~     lung cancer (NSCLC), first line advanced or metastatic biliary tract cancer, and first line~     metastatic or locally advanced bladder cancer.~   "
62421|NCT02240225|"~     Assessment of health-related quality of life in COPD patients with severe chronic~     respiratory failure requires appropriate and highly specific measurement tools. We attempt~     to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)~   "
62422|NCT02240212|"~     This is a Phase Ib, open-label, dose-escalation study to determine the Maximal tolerated~     dose (MTD) and the recommended Phase 2 dose (RP2D) for the combination of afuresertib and~     paclitaxel in subjects with recurrent HER2-negative gastric cancer, and further assess~     safety and preliminary efficacy of combination at the RP2D. Afuresertib had showed~     synergistic activity when combined with paclitaxel in vitro and in vivo models of gastric~     cancer. Dose escalation will continue until the MTD is established. The dose schedule is~     once daily (QD) dosing for afuresertib and intravenous (IV) infusion for paclitaxel Dose~     escalation in Part 1 will follow the 3 + 3 cohort design. A sequential approach will be~     conducted to explore the optimal paclitaxel regimen (weekly or 3weekly schedule) when~     combined with afuresertib. The dose escalation will be started from Cohort A (afuresertib~     combined with weekly paclitaxel regimen at 80 milligram (mg)/meter (m)^2 day1, 8,15, every 4~     weeks (q4w). The starting dose in Cohort A will be 125 mg afuresertib QD. Once its MTD is~     identified, and then the study will move to dosing Cohort B (afuresertib combined with 3~     weekly paclitaxel regimen at 175 mg/m^2 day1, every 3 week (q3w). The starting daily dose of~     Cohort B will be 25 mg less than the MTD dose from Cohort A for afuresertib. If it is~     tolerated, then the dose escalation schedule will be followed in Cohort B until the MTD in~     this Cohort is reached. If the starting dose is not tolerated, then dose de-escalation will~     be explored until the MTD in this Cohort is reached. Once two dimensions of the MTD are~     achieved, then the optimal regimen for paclitaxel and MTD for afuresertib combined with~     paclitaxel based on the toxicity profile will be identified. The combination regimen at the~     RP2D selected following Part I will be further investigated in its efficacy and safety in~     the Part II Expansion Cohort. Once a combination dose regimen for Part 2 has been~     determined, at least 20 and up to 40 subjects will be enrolled at the dose regimen selected~     following Part I. Overall response rate (ORR) will be evaluated using a Green-Dahlberg~     design. The design consists with one interim analysis. If less than 3 responses are observed~     in the initial 20 subjects, enrollment will be terminated due to futility; otherwise, the~     study will continue to meet the planned sample size of 40 subjects.~   "
62423|NCT02240199|"~     Breast tissue and the areas surrounding the breast contain many small to medium-sized~     nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged.~     Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves.~     These nerves eventually become abnormal and provide pain signals to the brain well beyond~     the healing period after surgery. Patients with these abnormal nerves suffer from chronic~     pain in the breast area that persists for several years after surgery. Chronic pain is~     associated with a reduced quality of life, daily functioning, psychological distress, and~     contributes to excessive health care expenditures. There is encouraging data suggesting that~     an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can~     prevent the development of chronic pain after breast cancer surgery. A large randomized~     controlled trial is needed to determine the efficacy of these two interventions on reducing~     chronic pain after breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is~     first needed to determine the feasibility of undertaking such a trial.~   "
62424|NCT02240186|"~     This study will assess if the functional performance and musculoskeletal outcome of~     transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a~     Non-Microprocessor Knees (NMPK).~   "
62425|NCT02240173|"~     Sorghum bicolor is a naturally growing plant which has been of health benefit to the people~     of West Africa who traditionally prepare its leaf for various nutritional and health~     reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates,~     Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains~     Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the~     determinants of mental health are complex, the emerging and compelling evidence for~     nutrition as a crucial factor in the high prevalence and incidence of mental disorders~     suggests that diet is as important to psychiatry as it is to cardiology, endocrinology, and~     gastroenterology. Evidence is steadily growing for the relation between dietary quality (and~     potential nutritional deficiencies) and mental health, and for the select use of~     nutrient-based supplements to address deficiencies, or as monotherapies or augmentation~     therapies. There is currently strong advocacy for the recognition of diet and nutrition as~     central determinants of both physical and mental health.Its anti-inflammatory and~     haematocrit boosting properties have been well documented though the precise mechanism of~     action is still largely unknown. Its use has recently been extended to the field of mental~     health where findings in animal study suggest it could be of help in relieve of psychosis.~     The need for this study is therefore aimed at investigating the effect of this drug in~     patients with schizophrenia which is the prototypical psychotic disorder.~   "
62426|NCT02240160|"~     To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose~     of Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg~     cannabidiol (CBD)) by comparing the PK profile of Sativex in healthy subjects.~      The primary clinical hypothesis is that there will be an effect of oral pH on the PK of~     Sativex when administered as a single oromucosal dose (four sprays).~   "
62427|NCT02240147|"~     Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even~     though outcomes are good, they need lifelong follow-up because of a higher risk for~     cardiovascular diseases. Studies have shown that patients with CHD are not active enough and~     that a substantial amount of patients is overweight. Hence preventive strategies and~     education should not only focus on the heart problem, but also on a healthy lifestyle~     including physical activity. Recently a new guideline introduced exercise prescription based~     on the absence/presence of certain key elements. However, a number of important questions~     remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'~     program for adults with CHD, based on this new guideline, will be investigated. This study~     is a randomized controlled trial that investigates the effects of the program on daily~     physical activity, exercise capacity, quality of life and exercise self-efficacy both in~     short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training~     effects by using a new exercise-testing protocol that looks simultaneously to all body parts~     that are involved during exercise. Ultimately, our findings will result in the~     implementation of the guideline in clinical practice.~   "
62428|NCT02240134|"~     Acute lower respiratory tract infections (LRTIs) account for more than 27% of all~     hospitalizations among US children under five years of age, with recurrent LRTIs in children~     a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor~     levels of fine particulate matter (PM2.5) that often exceed current health-based air quality~     standards. PM2.5 exposure is associated with many adverse health outcomes, including a~     greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in~     wood stove homes have been either inconsistently effective or include factors that limit~     widespread dissemination and continued compliance in rural and economically disadvantaged~     populations. In this project, the investigators propose to test the efficacy of two~     intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk~     of LRTI in three unique and underserved settings: (1) rural mountain valley communities in~     western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The~     investigators will conduct a three-arm randomized placebo-controlled post-only intervention~     trial in wood stove homes with children less than five years old. Education on best-burn~     practices and training on the use of simple instruments (i.e., stove thermometers and wood~     moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be~     evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3,~     sham air filters). The primary outcome will be LRTI incidence among children under five~     years of age. To allow for detection of exposure and outcome differences within each of the~     three regions, a sample of 324 homes, or 108 within each study area will be equally assigned~     to each of the three intervention arms. The overall hypothesis is that a low-cost,~     educational intervention targeting indoor wood smoke PM2.5 exposures will be sustainable,~     and can reduce children's risk of LRTI in underserved Native and rural communities.~   "
62429|NCT02240121|"~     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for~     the induction of clinical remission and endoscopic response following 16 weeks of treatment~     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to~     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.~   "
62430|NCT02240108|"~     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for~     the induction of clinical remission and endoscopic response following 16 weeks of treatment~     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to~     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.~   "
62431|NCT02240095|"~     Translation of new knowledge from research into evidence-informed health care is a shared~     obligation of the clinical and the scientific communities. Unfortunately, studies of quality~     of care continue to show that this goal is substantially unrealized. One main barrier is~     lack of quick and easy identification, appraisal and synthesis of current best evidence.~     This start with medical and nursing students, which have numerous clinical-related questions~     daily, but face a large volume of 3000 articles published every day, accessible in many~     scattered resources.~      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,~     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search~     (MPFS), an online search engine that provides a unique 1-stop search and organized access to~     current best evidence in daily practice. However additional barriers need to be overcome for~     students to actually search and use this evidence in their learning and practice. Theses~     include logistical barriers (time constraints, forgotten questions), as well as educational~     barriers (eg, lack of awareness of the architecture of evidence, limited searching skills,~     and lack of reference standards among peers for finding best evidence).~      In a previous trial, the investigators tested 3 innovative online interventions among~     clinicians registered to MPFS to overcome these barriers and increase the quantity and~     quality of searching for current best evidence to answer clinical questions (NCT02038439).~     The investigators seek to conduct a second randomized trial testing the same 3~     interventions, this time among medical and nursing students registered in MPFS.~   "
62432|NCT02240082|"~     This study is a clinical trial in which 300 Police Officers who currently work midnight~     shifts in the participating police departments will be recruited to test the effectiveness~     of a new web-based program to address sleep and associated problems related to shift work,~     particularly night shift work. Recruitment letters will be sent to all officers currently~     working midnight shift, with the goal of recruiting 300 officers willing to participate in~     the study. The 300 participants will be randomly assigned to either the experimental group~     (receiving the web-based program) or the waitlist control group. Participants in the~     experimental group will be given access to the program site (COPing with Shift Work) and the~     mobile application (Sleep Tracker). Following completion of the field test, participants in~     the control condition (as well as all other interested officers) will have access to the~     web-based COPing with Shift Work program.~      All participants will be asked to complete a baseline questionnaire containing multiple~     measures of sleep, dietary practices, physical activity and job performance. Participants~     will be asked to complete the posttest approximately three months following initial access~     to the intervention.~      Primary and secondary outcome measures: The Primary outcome measures are sleep quality as~     measured by the Pittsburgh Sleep Quality Index (PSQI) and sleepiness as measured by the~     sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The~     investigators have adapted the sleep measures to apply to individuals who work nights and~     may sleep during the day.~      Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of~     the Block Self-Administered Diet History Questionnaire assessing the nutritional value of~     the respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health~     Belief Model and developed and validated by Trenkner and associates assessing perceived~     benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise~     Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work~     productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated~     by Lerner and associates.~      It is expected that the program group participants will have significantly better outcomes~     than the control group at three months.~   "
62433|NCT02240069|"~     A critical need exists for efficient community-based interventions aimed at reduction of~     environmental exposures relevant to health. Biomass smoke exposures due to residential wood~     heating are common among rural Native American communities, and such exposures have been~     associated with respiratory disease in susceptible populations. In many of these communities~     wood stoves are the most economic and traditionally preferred method of residential heating,~     but resource scarcity can result in burning of improper wood fuels and corresponding high~     levels of indoor particulate matter. Community-based participatory research techniques will~     be used to adapt intervention approaches to meet the cultural context of each participating~     community. At the community level, investigators will facilitate local development of a~     tribal agency-led wood bank program ensuring that elderly and/or persons with need have~     access to dry wood for heating. At the household level, investigators will use a three arm~     randomized placebo-controlled intervention trial to implement and assess education/outreach~     on best burn practices (Tx1). The content and delivery strategies of the education~     intervention will be adapted to each community according to stakeholder input. This~     educational intervention will be evaluated against an indoor air filtration unit arm (Tx2),~     as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the~     other two treatment arms to evaluate the penetration and efficacy of the community-level~     wood bank program. Outcomes will be evaluated with respect to changes in pulmonary function~     measures and respiratory symptoms and conditions among household elders. The investigators~     hypothesize that locally-designed education-based interventions at the community and~     household levels will result in efficacious and sustainable strategies for reducing personal~     exposures to indoor particulate matter, and lead to respiratory health improvements in~     elderly Native populations. This study will advance knowledge of cost-effective~     environmental interventions within two unique Native American communities, and inform~     sustainable multi-level strategies in similar communities throughout the US to improve~     respiratory health among at-risk populations.~   "
62434|NCT02240056|"~     Certain cardiac and neurologic diseases influence each other via a still poorly understood~     brain-heart axis. Subarachnoidal bleedings are well known to cause ECG alterations~     resembling those of myocardial infarction, along with a reduction of systolic myocardial~     function (neurogenic stunned myocardium). Alterations of the right insula region by a~     stroke or intracranial hemorrhage go along with a sympathetic activation (increased~     circulating catecholamine levels, tachycardia, arterial hypertension). In contrast,~     alterations of the left insula region often cause vagal reactions such as bradycardia,~     arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform~     of heart attacks, often caused by psychological or physical stress (death of a beloved one,~     divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects~     postmenopausal women.~      Functional MRT enables imaging of activated brain regions, either without (resting state)~     or with specific stimuli. The investigators speculate that there is a specific involvement~     of the insula region during TTC.~   "
62435|NCT02240043|"~     The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic~     hormone (ACTH) secretion in elderly without hypothalamic-pituitary disease using the~     glucagon stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate~     some parameters such as sarcopenia, nutritional state, bone mineral density, frailty~     criteria with secretion of GH.~   "
62436|NCT02240030|"~     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the~     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing~     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the~     clinic.~      Patients who successfully complete this study will be eligible to enroll into a 12 month~     treatment extension (CVT-301-004E) study .~   "
62437|NCT02240017|"~     This is a phase II/III, multicenter, randomized study which includes 420 patients on six~     years + 3 years follow up. 92 patients will be included during the phase II ; additional 328~     patients will be included.~      Patients with an advanced or metastatic urothelial cancer with impaired renal function will~     be randomized in one of the two following chemotherapy arm:~        -  Fractionated Cisplatin + Gemcitabine.~        -  Carboplatin + Gemcitabine.~      The main objective of the part II study will be to evaluate the efficacy and the safety of a~     chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin~     or Carboplatin in this population.~      The main objective of the part III study will be to compare the efficacy in terms of overall~     survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated~     Cisplatin or Carboplatin in this population.~   "
62438|NCT02240004|"~     The aim of this study is to compare purification efficiency of HFR in terms of clearance of~     protein-bound toxins and the effects on markers of inflammation and endothelial damage, in~     comparison to HF-HD and OL-HDF.~   "
62439|NCT02239991|"~     A point-of-care bleeding management protocol based on global viscoelastic test~     (thromboelastometry) can change the amount of blood products used during orthotopic liver~     transplant.~   "
62456|NCT02239757|"~     Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly~     related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion~     time has not been fully studied for SETMI patients undergoing primary percutaneous coronary~     intervention (PCI). The aim of this study was to randomly investigate the efficacy and~     safety of left radial approach for primary PCI in STEMI patients compared with right radial~     approach.~   "
62457|NCT02239744|"~     This study aimed to evaluate whether a short-term indoor air purifier intervention improves~     cardiopulmonary health based on a randomized double-blind crossover trial~   "
62458|NCT02239731|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104~     Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving~     Cetuximab or Panitumumab.~   "
62440|NCT02239978|"~     The primary goal of this project is to gain a better understanding of whether and how~     levodopa (a common anti-Parkinson disease medication) alters postural motor learning in~     people with Parkinson disease. A secondary goal is to assess whether motor cortical~     excitability, measured via Transcranial magnetic stimulation, is related to postural motor~     learning.~      Participants with Parkinson disease will complete between 50 and 100 postural perturbations~     (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.~     levodopa). Adaptation of responses to these perturbations will be tracked. Participants will~     also undergo transcranial magnetic stimulation to capture cortical excitability of the brain~     (in particular the motor cortex). Cortical excitability will be correlated to adaptation of~     stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture~     postural motor learning and cortical excitability in age-matched healthy adults.~      Investigators hypothesize that dopamine will have a negative effect on postural motor~     learning, and the cortical excitability will be correlated to postural motor learning.~   "
62441|NCT02239965|"~     Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications~     and patient discomfort. However, monitoring is not applied consistently by Danish~     anaesthesia personnel. Surveys show that part of the explanation is that the anaesthetists~     often experience problems with the equipment used for monitoring, though the problems have~     not been described in detail.~      We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by~     insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in~     interpreting the measurement results.~   "
62442|NCT02239952|"~     The purpose of this study is to determine intratumoral concentration of kinase inhibitors~     upon 2 weeks of treatment in tumor tissue (in the brain) of patients with high-grade gliomas~     (HGG).~   "
62443|NCT02239939|"~     The purpose of this research study is to see whether wearing a weighted vest during a period~     of active weight loss can decrease the loss of muscle and bone that occurs during weight~     loss. We will also determine if study participants who wear the weighted vest will have~     greater improvements in physical function and self-reported disability, pain, stiffness,~     fatigue and quality of life. This knowledge could impact weight loss programs designed for~     older adults.~      Hypothesis: Participants randomized to VEST will experience similar weight loss, but less~     loss of lean mass and bone density, than participants randomized to Control.~   "
62444|NCT02239926|"~     Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?~   "
62445|NCT02239913|"~     This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),~     alone and in combination, on the reinforcing, subjective and physiological effects of~     cocaine.~   "
62446|NCT02239900|"~     The goal of this clinical research study is to find the highest tolerable dose of ipilimumab~     and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these~     treatments given consecutively will also be studied.~   "
62447|NCT02239887|"~     Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage~     Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular~     atrial fibrillation in patients who are at increased risk for embolic stroke and have an~     ongoing indication for oral anticoagulation.~   "
62448|NCT02239874|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and~     will examine whether vitamin D effects mammographic breast density, mammographic texture~     features, and gene expression profiles in breast biopsy tissue.~   "
62449|NCT02239861|"~     This is a clinical trial for patients with a solid tumor which has come back, or may come~     back, or has not gone away after treatment, including the standard treatment we know for~     these diseases. This is a study using special immune system cells called tumor-associated~     antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.~      The proteins that the investigators are targeting in this study are called tumor-associated~     antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they~     either do not show or show up in low quantities on normal human cells. In this study, the~     investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a~     different study, patients have been treated and so far this treatment has shown to be safe.~      The investigators now want to try this treatment in patients with solid tumors.~      This protocol is designed as a Phase I dose-escalation study.~   "
62450|NCT02239835|"~     Objectives of the study were to evaluate the efficacy and safety of two different doses of~     tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI~     combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two~     different doses of TPV in combination with RTV for efficacy and safety.~   "
62451|NCT02239822|"~     Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive~     Disorder. The primary objective is to assess the safety and tolerability of eTNS (external~     trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive~     treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).~   "
62452|NCT02239809|"~     Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive~     Disorder. The primary objective is to assess the safety and tolerability of an implantable~     sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients~     with the diagnosis of unipolar MDD (Major Depressive Disorder).~   "
62453|NCT02239796|"~     To aim of this study is to establish the feasibility of undertaking a phase III trial of~     transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate~     stroke-related urinary incontinence.~   "
62454|NCT02239783|"~     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the~     safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU)~     . These types of studies are required by regulatory authorities for all THA devices that do~     not have clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
62459|NCT02239718|"~     Tooth replacement is a significant issue in the World and while dental implants and~     conventional bridges have been used to replace missing teeth, dental implants are too~     expensive for many and conventional dental bridges are destructive to supporting tooth~     tissue.~      Resin-bonded bridges (RBBs) are a conservative and cost effective replacement option that~     involves minimal tooth preparation, leaving the majority of the tooth intact. They are~     secured in place with an adhesive cement, which is bonded to the outer enamel layer.~     Clinical audit of these prostheses at the University of Hong Kong shows two-unit RBBs to~     have some of the highest success rates in the dental literature for the replacement of~     missing premolar and incisor teeth. However, for the replacement of molar teeth, two-unit~     RBBs are not performed, as established protocol and recognised texts contraindicate their~     use due to concerns with tipping or drifting of supporting teeth. Replacement of a single~     missing molar tooth can be with a three-unit, fixed-fixed (single-piece casting) or~     three-unit, fixed-movable (two-part casting). However, the fixed-fixed option has a higher~     debond failure rate than two-unit RBBs and therefore, at this centre, a modified, 3-unit~     fixed-movable design is used. This two-part casting allows for minor, independent movements~     of the supporting teeth and thereby aims to reduce stresses between them and, similarly,~     reduce de-bonding forces. This has the potential for greater longevity and easier long-term~     maintenance as if the major part of the bridge debonds it can be recemented.~      The aim of this unique study is to compare 2-unit and 3-unit RBBs for the replacement of~     single missing molar tooth in a randomized clinical trial. These two designs will be~     clinically evaluated at 6 months , 1 year, 2 years and 3 years to observe the outcome~     measures. The primary outcome will examine the success of the dental prostheses with~     respects to the need of any clinical intervention to repair or remediate the RBB or~     supporting tooth. Minor outcome measures will examine fatigue or damage to the prosthesis,~     changes in bone support, pulpal or periodontal health or tooth mobility. Patient~     satisfaction and quality of life evaluation of the dental prostheses will also be examined.~     Will 2-unit RBBs offer patients a simpler, cheaper, and successful option over current~     designs? This has not been previously reported.~   "
62460|NCT02239705|"~     The purpose of this study is to investigate whether cardiac output (CO) and global end~     diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are~     mathematically coupled during the infusion of fluid or inotropic agents in critically ill~     patients.~   "
62461|NCT02239692|"~     This was a phase 3, randomised, assessor‑blinded, multi‑centre trial comparing the efficacy,~     safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day‑before~     dosing schedule for colon cleansing in preparation for colonoscopy.~   "
62462|NCT02239679|"~     The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and~     effective in the treatment of actinic keratoses on the face, following treatment with liquid~     nitrogen cryotherapy.~   "
62463|NCT02239666|"~     To estimate the real-world effectiveness of approved biologics in subjects with~     moderate-to-severe plaque psoriasis who are either starting or switching biologic~     medication.~   "
62464|NCT02239653|"~     Objective: to test the hypothesis that an intervention comprised of targeted physician and~     print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB)~     and fruit juice they give to their children 1 - 12 years of age.~   "
62465|NCT02239640|"~     The purpose of this registry is to assess outcomes associated with the use of devices~     intended to restore blood flow in patients experiencing acute ischemic stroke.~   "
62466|NCT02239627|"~     Low back pain is a common condition, affecting majority of the adults in the United States~     at some point in their lives. Fortunately, most resolve, even without treatment. However,~     some suffer from continued or recurrent pain.~      For those suffering from continued or recurrent low back pain, numerous treatment options~     exist. One such option is an epidural injection, particularly when other non-surgical~     treatment options have failed. An epidural injection is the placement of a needle into the~     space around the spinal cord with the aid of a live X-Ray machine, followed by an injection~     of various medications. Typically, the medication that is injected is a steroid, commonly~     with the combination of local anesthetic medication. Epidural steroid injections, with or~     without local anesthetic is part of the established standard of care in the United States~     for those with continued or recurrent low back pain. The steroid is believed to reduce~     inflammation and edema of the injured or irritated nerves. However, despite the routine use~     of epidural steroids, the steroid itself is not without risks or side effects. Though rare,~     the steroids have been associated with complications including osteoporosis, steroid induced~     myopathy, cataracts and many others. In order to minimize the side effects associated with~     epidural steroids, limiting the dose and frequency have been outlined.~      Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and~     Drug Administration approved the medication for epidural use for cancer pain but studies~     have shown effectiveness in non-cancer pain was well and is routinely used for various~     conditions. There is growing evidence on the use of epidural clonidine for treatment of~     pain, including low back pain.~      This research will study and compare the effectiveness, if any, of clonidine compared to~     steroid in an epidural injection for low back pain.~   "
62467|NCT02239614|"~     The potential synergistic effect of administering 2 dengue vaccine candidates that were~     previously shown to be safe and immunogenic in humans will be evaluated in this study. A~     prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with~     alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17)~     will gather data to help better understand the human immune response to dengue vaccination~     and infection.~   "
62468|NCT02239601|"~     The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. A theory is~     that the microtubule-stabilizing agents that prevent division of cells also affect healthy~     peripheral nerves. Symptoms of CIPN are in the hands/feet and include: pain, numbness, and~     loss of function. An estimated 55-60% of patients will experience lasting symptoms affecting~     function for years post-treatment. Research on nerve disorders identifies that a nerve~     already entrapped/damaged at one site may be at greater risk when combined with chemotherapy~     (double crush syndrome). Physical therapy is an established, effective treatment for~     entrapped nerves and neuropathic pain. This study seeks to identify additional risk factors~     and provide evidence for the role of physical therapy in the treatment of CIPN.~      Hypotheses~        1. Physical therapy will assist in managing symptoms (sensory, pain, edema) compared to~          the control group during chemotherapy.~        2. Positive tests for mechanical entrapment prior to chemotherapy will result in more~          severe symptoms of CIPN.~        3. The treatment group will have greater resolution of CIPN symptoms compared to control~          at the six month follow-up.~   "
62469|NCT02239588|"~     This was a randomized, double-blind, single-center, placebo-controlled, three-arm study,~     with a 12-week intervention period.~      The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6~     months) milk powder on:~        1. Bone health;~        2. Infants growth;~        3. Intestinal health;~        4. Gastrointestinal tolerance to the test product;~      g) Incidence of Eczema~   "
62488|NCT02239328|"~     This survey study is looking to determine if patient reported outcomes(using the PROMIS~     survey) will vary according to the presence of recurrent or metastatic lung or esophageal~     cancer.~   "
62489|NCT02239315|"~     The purpose of this study is to find out if the pathological complete response (pCR) to~     chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the~     evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA~     score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third~     cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant~     chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast~     cancer management.~   "
62470|NCT02239575|"~     This study will enroll specimens from subjects diagnosed with various cancers and who have~     either:~        1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor~          and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within~          the local (or affiliated) pathology archive (replicate blocks from same tumor) or~          blocks no longer required to be maintained on file - discard blocks, or~        2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to~          scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After~          surgery, surplus tissues (including tumor and adjacent normal tissues) not required for~          diagnosis will be collected.~      Subject clinical information will be collected, including basic demographic information,~     medical history, current cancer history and treatment. A final pathology report will be~     obtained for each subject's surgical specimen. In some instances, and based on the cancer~     indications required, longitudinal data may also be collected at a frequency of every 6~     months to once per year. Longitudinal data will include information on study subject~     survival and disease recurrence.~   "
62471|NCT02239562|"~     The purpose of this study is to study the safety and tolerability of synthetic~     PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune~     hepatitis is a disease where the patient's immune system produces an inappropriate immune~     response against their own liver. PreImplantation Factor is a substance that is secreted by~     viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing~     the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous~     properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in~     preclinical models of autoimmunity and transplantation (published). Specifically sPIF~     protected the liver against immune attack. In FDA mandated toxicity studies (mice, dogs),~     high-dose sPIF administration for 2 weeks followed by 2 weeks observation period~     demonstrated a high safety profile. Based on those observations the FDA has granted a Fast~     Track designation for this trial. This study will evaluate the safety, tolerability and the~     blood level of this synthetic version of this natural compound in the circulation.~   "
62472|NCT02239549|"~     The purpose of this study is to evaluate and compare the incomplete resection rates for~     small colon polyps less than or equal to 6 mm in size using two conventional polypectomy~     tools, jumbo cold biopsy forceps and cold snare.~   "
62473|NCT02239536|"~     The complete removal of colorectal polyp is required to prevent tumor recurrence and~     development of potential interval cancers. However, several studies have shown high~     incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than~     5 mm. The polypectomy techniques using hot snare are usually used for the removal of these~     polyps. However, the optimal technique for complete resection of these polyps is unknown.~     There are few data comparing hot snare polypectomy with hot snare polypectomy after saline~     injection for complete resection of colorectal polyps (5mm or larger). The aim of this study~     is to compare hot snare polypectomy with hot snare polypectomy after saline injection for~     removal of 5-10mm sized colorectal polyps.~   "
62474|NCT02239523|"~     Patients who present with fragility fractures are consistently under-evaluated and~     under-treated for underlying osteoporosis. This point of care represents a lost opportunity~     to prevent future fractures. The medical field treats the fracture as if the fall is the~     problem, but bone quality is the real problem. Studies have consistently shown that the~     recommendations of the International Osteoporosis Foundation and World Health Organization~     are not being followed. Orthopedics treats the patients for their fractures and primary care~     physicians focus on general health but no one is taking responsibility for bone health.~     Strategies to convince primary care to assume care have not succeeded. On the other hand,~     strategies where orthopedics takes some responsibility have shown success. This prospective~     2-arm study will evaluate the success of effort by an academic orthopedic department in~     osteoporosis evaluation and treatment. We hypothesize that with greater effort by the~     orthopedic department, the better the adherence to standards of care. A cost benefit~     analysis will be made in parallel.~   "
62475|NCT02239510|"~     In this prospective, randomized, double blind study, the aim is to determine the efficacy of~     Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic~     constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and~     randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during~     the study and will be followed for 12 weeks. Main outcomes include number of daily bowel~     movements and measures from surveys regarding bowel habits, relief, and satisfaction.~   "
62476|NCT02239497|"~     Proper management of acute postoperative pain (DAPO) is essential for the recovery of~     orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and~     its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To~     evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower~     limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two~     groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15)~     received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus~     epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous~     analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general~     anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4~   "
62477|NCT02239484|"~     We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and~     Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and~     both together in a 3 period repeatedly.~   "
62526|NCT02238860|"~     Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents~     have been claimed equivalent in treatment, there are no head to head trials available in the~     literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed~     to compare safety/efficacy and virological response in patients with HBV Decompensated~     Cirrhosis.~   "
62527|NCT02238847|"~     The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to~     Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary~     obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.~   "
62528|NCT02238834|"~     This is a randomized, placebo controlled, single and multiple ascending dose study to assess~     the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.~   "
62478|NCT02239458|"~     Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The~     underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of~     investigation. In addition to localized tissue damage developing similar to that of the~     exocrine pancreas, other mechanisms may be involved. We have shown that a potential~     contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal~     profile, specifically of lower incretin hormone responses, prior to development of CFRD.~      We propose that an altered incretin response, probably due to impaired interaction of~     nutrients with the gut mucosa due to thickened secretions, may play a role in the~     development of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell~     function observed in these patients prior to CFRD appearance. These incretins have known~     trophic effects on β-cells, and thus their lower levels may contribute to the development of~     quantitative as well as qualitative defects in β-cell function and thus may lead to the~     development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may~     improve glucose metabolism and delay/prevent the development of CFRD.~      We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus~     provide relative protection from diabetes development and in addition we expect that~     Saxagliptin will lead to overall increased insulin concentrations and thus shift the~     metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction~     in inflammation.~   "
62479|NCT02239445|"~     The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine~     is as effective as second dose of oral chloral hydrate for rescue sedation in infant age~     between 1 and 6 months who were not adequately sedated following initial dose of chloral~     hydrate.~   "
62480|NCT02239432|"~     Early adenocarcinoma of the lung has an excellent five-year survival after resection.~     However, its clinical and radiologic presentation is highly variable. Traditional means for~     preoperative diagnosis such as Positron Emission Tomography (PET-CT) and trans-thoracic~     needle biopsy demonstrate unacceptable false positive and negative rates.~      Telomere biology is activated aberrantly is most lung cancers but has not been studied in~     early stages to the best of our knowledge.~      The objective of this study is to evaluate telomere length and activity with suspected early~     stage adenocarcinoma of the lung.~   "
62481|NCT02239419|"~     Foot ulceration usually precedes more serious foot complications such as infection, gangrene~     or amputation. The risk of developing foot ulcers has been estimated to be higher in~     individuals with kidney disease. Patients with kidney disease receiving dialysis have an~     increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been~     reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate~     the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on~     treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis.~     Forty individuals how have a distal extremity ulcer who are currently undergoing~     hemodialysis will participate in this study.~   "
62482|NCT02239406|"~     The purpose of this study is to determine if avascular necrosis of the acetabulum is present~     in metal-on-metal revisions and to what depth this dead avascular bone occurs.~      A convenient sample of a consecutive series of 15 patients treated for metal on metal~     acetabular revision surgery will be included.~   "
62483|NCT02239393|"~     The mechanism of action of MSC relies on their ability to modulate pathogenic immune~     responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant~     and trophic factors as demonstrated by in-vitro and in-vivo preclinical studies.~      Patients will be randomized to receive immediate vs. delayed treatment with either a dose~     equal to 1-2 millions/kg of body weight of autologous MSC, or equivalent volume of~     suspension media at baseline. At week 24 treatments will be reversed.~      The primary outcome of this study is to evaluate:~        -  Treatment's safety within one year from MSC administration by measuring the number,~          time-frame and severity of adverse events and~        -  Treatment's activity in terms of reduction in total number of gadolinium-enhancing~          lesions (GEL) by magnetic resonance imaging (MRI) scans.~      Secondary outcomes are to gain preliminary information on the efficacy of the experimental~     treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and~     disability progression).~   "
62484|NCT02239380|"~     The purpose of this study is to determine the efficacy, safety and pharmacokinetics of~     Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.~   "
62485|NCT02239367|"~     The goal of this proposed pilot study is to test the feasibility and acceptability of a~     Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR)~     and used by nurses with depressed ambulatory care patients. The Depression Decision Aid~     protocol is a streamlined adaptation of an in-person Shared Decision-Making (SDM)~     intervention, and its goal is to increase patient involvement in clinically appropriate~     treatment decision-making as a way of strengthening treatment engagement and outcomes. The~     protocol guides ambulatory care nurses in helping depressed patients (Patient Health~     Questionnaire-9 [PHQ-9] >10) develop informed treatment preferences through a process of~     education and values clarification. We will target patients in the general medical clinic,~     whether currently receiving depression treatment or not, because depression is highly~     prevalent but often poorly managed in this population.~   "
62486|NCT02239354|"~     The purpose of this trial is to test if VC-01™ combination product can be implanted~     subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will~     also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.~   "
62487|NCT02239341|"~     The current standard of care for pregnant women deemed to be high-risk often involves~     recommending varying levels of activity-restriction, up to and including hospitalization.~     High levels of activity-restriction can lead to physical deconditioning of the mother, which~     can be difficult to recover from after birth. The proposed study will investigate whether a~     mild muscular conditioning program conducted in bed and given to hospitalized~     activity-restricted high-risk pregnant women will improve functional ability, cardiovascular~     deconditioning and overall quality of life in the postpartum period compared to a control~     group with no in hospital bed-rest exercise program. We hypothesize that women with a~     in-hospital muscle conditioning program will be better able to perform functional ability~     tasks and activities of daily living than a control group with no exercise program.~   "
62490|NCT02239302|"~     Obstructed defaecation syndrome is a common problem in which patients experience difficulty~     to evacuate stools and feel that the bowel is incompletely empty, which causes the need to~     put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a~     significant effect on social, physical, emotional and sexual wellbeing all of which have~     impact on quality of life. These symptoms are caused by posterior compartment disorders such~     as the last part of the large bowel bulging into the vagina (rectocele), the small bowel~     pressing on the rectum (enterocele), a circumferential infolding of the rectal wall~     (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate~     (anismus).~      Currently the evacuation proctogram is the gold standard for diagnosis of posterior~     compartment disorders. This technique, however, exposes the patient to ionising radiation,~     requires preparation of the small and large bowel with contrast and defaecation in a~     non-private setting, which most women find embarrassing and unpleasant. Over the years,~     research has focussed on identifying alternatives that are better tolerated to substitute~     evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast~     and a well-tolerated method for the dynamic and static imaging of the pelvic floor without~     the use of ionising radiation. The level of agreement between transperineal ultrasound~     (TPUS) and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to~     proctography. The aim of this study is to assess the level of agreement between ultrasound~     (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment~     disorders.~   "
62491|NCT02239289|"~     The purpose of the present study is to evaluate the benefit of biofeedback training on the~     capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles~     activity during trunk full flexion and its relationship with changes in clinical outcomes.~     To do so, twenty patients with nonspecific mechanical low back pain will be recruited and~     all participants will take part in four sessions of supervised biofeedback training,~     consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized~     that participants will have improved neuromechanical parameters with the biofeedback~     training and that this improvement will be positively associated to changes in clinical~     outcomes. This study will also allow for generation of preliminary data, in order to plan~     for a larger randomized control trial.~   "
62492|NCT02239276|"~     This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic~     encephalopathies associated with sodium channel mutations who have failed other drugs in an~     effort to give them the best chance at seizure control and quality of life. As a treatment~     protocol and not a research study, children will only be monitored on a clinical basis for~     seizure improvement and side effects predominantly by parent and caregiver report.~   "
62493|NCT02237300|"~     Introduction: The purpose of this research is to develop a new component for~     cognitive-behavioral treatment (CBT), empirically validated, for binge eating behavior in~     patients with bulimia nervosa (BN) and binge eating disorder (BED), by means of cue-exposure~     therapy (CET) with virtual reality. While CBT is an effective treatment for these eating~     disorders, an important percentage of patients do not improve despite treatment. It is~     necessary to explore how to enhance the effectivity of usual treatments with the~     incorporation of new technologies and procedures. The innovation of this investigation is~     based on the use of VR for cue-exposure therapy, which has been found effective with~     patients resistant to conventional treatments (CBT and pharmacological intervention), and~     seeks to enhance this efficacy by increasing possibilities of generalization and providing~     more useful tools to clinicians, diminishing the logistic complications of the exposure to~     real cues (food).~      Participants: 60 patients with a diagnosis of BN or BED according the DSM-5 who had been~     proposed for participation in the study by their referral mental health's professional after~     conducting unsuccessfully a first level treatment (CBT structured intervention) at the~     clinical sites involved will participate in the study.~      Procedure: Participants with active episodes of binge eating (and purging, in the case of~     BN) during the last 2 weeks of the structured intervention of CBT will be provided with~     detailed information about the study. All patients who agree to participate in the study and~     who sign the informed consent form will be randomly assigned to one of the two second-level~     treatment conditions: virtual reality based cue-exposure therapy (VR-CET) or additional~     cognitive-behavioral treatment (A-CBT). Both second-level treatment conditions consist of~     six 60-minute sessions that are held two times per week over a period of three weeks.~      In an interview setting, all of the participants will be administered several questionnaires~     (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) and participants assigned to the~     VR-CET will also be exposed to various types of virtual foods in different virtual~     environments (kitchen, dining-room, bedroom, and café) where they will be asked about their~     food cravings and anxiety experienced in each situation to develop a proper exposure~     hierarchy according to the specific characteristics and needs of each patient.~   "
62494|NCT02237287|"~     Background: The wound healing promoting effect of negative wound pressure therapies (NWPT)~     takes place at the wound foam interface. Implementation of bioactive substances at this site~     represents a major research area for the development of future NWPT devices.~      Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure~     devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine~     nanofibers (sNAG) was studied in a prospective randomized clinical trial.~   "
62495|NCT02237274|"~     Important advances in cardiac surgery, intensive care, and diagnostic modalities over the~     last decades have led to a steady growth in the number of adults with congenital heart~     defects. Among adults with congenital heart disease, patients with a Fontan circulation~     typically show the lowest values of peak oxygen consumption. For these patients, strict~     exclusion from activities at high altitude may have an impact on quality of life. The~     investigators aim to elucidate the short term effects of a stay at high altitude on~     hemodynamic adaptation, exercise capacity and clinical well being in adult Fontan patients.~     The investigators hypothesize that patients with a Fontan circulation in NYHA functional~     class I-II are able to increase their cardiac output during exercise at high altitude in~     order to meet the required metabolic demands and therefore tolerate the journey to the~     Jungfraujoch well.~   "
62529|NCT02238821|"~     The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,~     featuring association of carcinogenesis with a blood procoagulant disorder. MET is~     frequently overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE)~     may occur in association with poor prognosis, but the biological and genetic factors that~     cause VTE are still obscure.~      The Investigators propose to study whether in patients harboring a surgically resectable~     colorectal cancer the MET oncogene is expressed and may be associated with a blood~     thrombophilic condition that favors the onset of VTE.~      These data would have two main implications: (i) for the first time, a direct genetic link~     between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)~     the procoagulant alterations would have diagnostic/prognostic significance for the~     identification of patients at risk for poor outcome, and implementation of appropriate~     therapeutic protocols.~   "
64851|NCT02208466|"~     In this study investigator's aim to assess the effect of a type of non-invasive brain~     stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in~     conjunction with fluoxetine on motor recovery after stroke.~   "
62496|NCT02239250|"~     DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH)~     are delivering an intervention, consisting on the free distribution of one advance water~     filter and one improved cookstove to all household classified as ubudehe 1 and 2 according~     to government approved registers (poorest tertile), in Western Province. The aim of this~     intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases~     and pneumonia in Rwanda.~      The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an~     independent evaluation of this large-scale intervention to assess its impact on health. The~     trial will evaluate whether the provision of improved cookstoves and advance water filters~     can reduce pneumonia and diarrhoea disease in children under 5 years of age.~      A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will~     be use to answer this question. The 96 sectors in Western Province, Rwanda, will be~     randomised to either receive the intervention or the control. Each eligible household in~     intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen~     Lifestraw Family™ 2.1 water filter free of charge. Eligible households in control sectors~     will continue with their traditional cooking and drinking practices. Health data on children~     under 5 years of age will be collected from community health worker (CHW) and health~     facility records all across Western Province to evaluate the health impact of the~     intervention. The study will encompass 12 months of follow-up. After this time the control~     sectors will receive the intervention.~      This independent evaluation will also include a nested village-level study within the larger~     sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the~     intervention, as well as to assess the impact on environmental exposures and health~     outcomes. 174 villages (74 controls and 74 intervention) will be selected for participation.~     Household surveys will be used to collect data on intervention use and acceptability as well~     as on self-reported health data. Water samples will be collected and monitoring of exposure~     to Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure,~     expirated Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and~     or children under 5 years of age. Additionally, as part of this nested study, two~     exploratory studies will also be conducted. One will be focused on assessing the potential~     of biomarkers as indicators of environmental exposures (mainly HAP and water quality) and~     health status, while the other exploratory sub-study will assess the reactivity of~     participants to the use of remotely reporting electronic sensors to measure target~     behaviours.~   "
62497|NCT02239237|"~     This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the~     potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind~     of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis)~     and Rhizoma Heterosmilacis Japonicae.~   "
62498|NCT02239224|"~     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in~     the treatment of adult patients with molecularly defined genetic muscular dystrophies~   "
62499|NCT02239211|"~     This is a phase II study to determine the safety and preliminary efficacy of a human~     monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its~     use in the treatment of patients with primary sclerosing cholangitis (PSC).~   "
62500|NCT02239198|"~     There are prevalent micronutrient and fiber deficiencies in a significant proportion of US~     population, particularly among the overweight or obese. Intensive lifestyle counseling~     results in modest, measurable dietary improvements and weight stabilization, yet falls short~     of restoring optimal nutritional status and metabolism. A carefully formulated nutritional~     supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct~     micronutrient deficiencies in overweight or obese adults and children. This may have a~     beneficial impact on traditional indices of insulin dysregulation and the metabolic~     syndrome, gut inflammation, redox status, immune function and DNA integrity, and may~     favorably influence weight change and fat distribution.~      The investigators believe that the improvements seen with CHORIBAR trials will be mediated~     at the level of generalized enhancement in cellular metabolism that are not readily achieved~     with lifestyle counseling alone. The investigators suspect this is due to many nutritional~     barriers, some of which are disproportionately borne by inner city populations, such as cost~     and access to healthy food. The investigators hypothesize that a nutritional supplement like~     the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic~     and weight outcomes.~   "
62501|NCT02239185|"~     Aim of the study The aim of this study is to test the hypothesis that during laparoscopic~     hernia repair, disconnection of the hernial sac along with suture ligation of the neck is~     better than transperitoneal purse string suture around the hernial sac at the neck leaving~     the sac in continuity. Also to compare the two different laparoscopic techniques as regards~     operative time, recurrence rate, hydrocele formation, and other possible complications as~     bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic~     results.~   "
62502|NCT02239172|"~     The purposes of this study is to evaluate and compare the safety, reactogenicity, and~     tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel~   "
62503|NCT02239159|"~     The investigators assume that transcutaneous electric acupoint stimulation (TEAS)~     pretreatment may activate the endogenous protective mechanism, as a result protect the~     patients against subsequent surgical stress pregnancy. And TEAS may induce the production of~     endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The~     investigators believe this intervention will reduce the subsequent incidence, duration and~     severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this~     study, the investigators hypothesize that TEAS before anesthesia and during surgery would~     decrease the morbidity and mortality of postoperative complications in 30 days after~     digestive surgery in elderly patients .~   "
62504|NCT02239146|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor~     XIII, catridecacog) administered following first time myocardial revascularization requiring~     cardiopulmonary bypass (CPB).~   "
62530|NCT02238808|"~     Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+~     tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot.~     Currently, there is no perfect way to tell these groups apart nor do the investigators know~     why some respond when others do not.~      Research findings suggest that the two types of ER+ breast cancers differ in their response~     to estrogen with estrogen being toxic to one type and not the other. For those tumours that~     find estrogen toxic, this may explain why tumours only start to grow when estrogen levels~     decrease after menopause.~      The purpose of this study is to see whether a two-week treatment of estrogen equal to~     pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow.~     This will be done by comparing the growth rate in the tissue removed during standard of care~     surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.~   "
62783|NCT02235467|"~     This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis~     (ABA) parent training using video modeling to teach parents of children with Autism~     techniques to apply to their children in order to improve eye contact and joint attention~     behaviors.~      Our hypothesis is that children with Autism whose parents will be trained by videomodeling~     will have better eye contact and joint attention behaviors compared to children with Autism~     whose parents will not be trained.~   "
62505|NCT02239133|"~     The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and~     Termination.~      Subject screening will be held during visit one (1) and visit two (2) at the clinic.~      Initiation and Size fitting:~      All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during~     visit 2, to find the suitable size for her. The subject will use the ProVATE device of the~     chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home~     environment, to confirm that the chosen size is appropriate for the user. Each usage will be~     followed by a vaginal examination. In case the investigator will determine that the subject~     should be fitted with a different size of the ProVATE device the subject will repeat this~     stage with a different device size until the suitable size is confirmed by the investigator.~      Usage:~      The subject will use the ProVATE device for at least 28 days during a 45 days period, at her~     home environment, and fill a usage diary. Each device will be used for at least 24 hours. At~     least one (1) follow-up phone call will be held with the subject per a week. After 14 usage~     days or following at least two (2) usages (the latest of them) the subject will be scheduled~     for vaginal examination at the clinic (visit four (4)).~      End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a~     vaginal examination and additional activities.~      The following questionnaires will be filled at baseline and end of study: Quality Of Life~     (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the~     end of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.~   "
62506|NCT02239120|"~     This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown~     source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1~     ratio) and have visits every three months. The study doctor may prescribe blinded~     concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse~     Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will~     conclude when the required number of stroke events are positively adjudicated which is~     estimated to take 3 years (including 2.5 years of enrollment).~   "
62507|NCT02239107|"~     Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of~     reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily~     by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene~     resistance and second line treatment is either laparoscopic ovarian drilling or~     gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring~     ovulation and achieving pregnancy, some women still remain anovulatory and infertile after~     the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic~     drilling to improve ovulation and pregnancy rate.~   "
62508|NCT02239094|"~     We propose to conduct a pilot study of biological predictors of lurasidone response in~     bipolar depression.~   "
62509|NCT02239081|"~     This is a Phase 1, single center, single-ascending dose, randomized study~   "
62510|NCT02239068|"~     Hypothesis: The investigators hypothesize that more than 50% of the patients receiving~     enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric~     fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by~     using region of interest in the CT technique is accurate compared to blind aspiration of the~     gastric contents with a syringe and a multi-orificed orogastric tube.~   "
62511|NCT02239055|"~     Despite expert opinion unconvinced of any value for hospitalization in caring for people~     with borderline personality disorder (BPD), this patient group still accounts for a~     significant proportion of adult acute mental health (AMH) admissions. Staff nurses generally~     voice negative perceptions of BPD, a view which is linked to an uncertainty of how to~     approach these patients, and difficulties leading to personal distress and burnout.~     Mentalization-based treatment (MBT) is an evidence based approach, focusing on the mental~     states of both self and others, developed specifically to treat BPD and facilitated~     successfully in specialised settings. MBT Skills training is a compact and cost effective~     two day workshop which equips generalist mental health nurses with a skillset enabling them~     to work effectively with BPD. MBT Skills training was first offered to staff nurses in Royal~     Cornhill Hospital, Aberdeen in 2013. This study aims to assess staff perceptions on the~     value of MBT skills training, evaluating how it impacts on clinical practice when working~     with BPD in AMH.~   "
62512|NCT02239042|"~     The aim of the present study was to evaluate the influence of LLLT on the recovery of the~     palatine donor site wounds after harvest connective tissue graft.~   "
62513|NCT02239029|"~     Although few studies have showed beneficial effect of platelet rich plasma (PRP) for~     osteoarthritis of knee (OA knee), only one study applied randomized, control method and none~     of them has the objective measurements such as balance test or muscle strength which were~     reported as decrease in patients with OA knees. We assess the analgesic effect and the~     extent of improved muscle strength and balance after PRP in patients with OA knee.~   "
62514|NCT02239016|"~     This study aims to study the temporal course of sickle nephropathy and assess novel~     biomarkers that can predict patients prone to nephropathy.~   "
62515|NCT02239003|"~     NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were~     found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This~     study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be~     allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500~     mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that~     DAOIB may yield better efficacy than placebo for cognitive function in patients with mild~     cognitive impairment.~   "
62516|NCT02238990|"~     The following trial is a multicenter and prospective research trial of the colposcopy unit~     of luebeck university and the national research center in Borstel, Germany.~      The study is to identify and evaluate new biomarkers in human papilloma virus (HPV)~     associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue~     samples being removed during conizations and/or hysterectomies are to be fixed in HOPE`s~     solution and analyzed according to their transcriptomes and methylosome. The hereby found~     candidates are to be validated using immunohistochemistry and RT [real-time] -PCR~     [polymerase chain reaction].~      The project is meant to be followed by continuous studies developing a new test describing~     the malignant potential of HPV associated genital lesions.~   "
93099|NCT01838590|"~     This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus~     ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.~   "
62517|NCT02238977|"~     The proposed study will evaluate the response and remission rates for major depressive~     disorder (MDD) in end-stage renal disease (ESRD) patients undergoing maintenance~     hemodialysis (HD) treated with bupropion or fluoxetine for 12 weeks. In addition, the study~     will document the relative tolerability and safety, and longitudinally contrast the effects~     of bupropion and fluoxetine on measures of cognitive function, fatigue, inflammation, and~     tryptophan (TRP) and TRP catabolites in blood. It is hypothesized that both drugs will~     significantly reduce MDD symptoms from baseline, and be tolerable and safe, but bupropion~     will be associated with greater reduction in pro-inflammatory cytokines, cognitive~     impairment, and fatigue compared with fluoxetine.~      The Specific Aims of this study are:~      Aim 1: Determine the efficacy of bupropion and fluoxetine in treatment of MDD in ESRD/HD~     patients.~      Aim 2: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and~     fatigue differ between bupropion and fluoxetine.~      Aim 3: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and~     fatigue correlate with change in inflammation, measures of TRP availability to brain, or~     neurotoxic TRP metabolites.~      Hypotheses:~        1. Bupropion and fluoxetine will both show efficacy in treating MDD;~        2. Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than~          fluoxetine; and~        3. Change in cognition and fatigue over time will correlate with change in c-reactive~          protein (CRP) and quinolinic acid and change in overall depression score will correlate~          with measures of TRP availability.~   "
62518|NCT02238964|"~     ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of~     stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen~     mesh (Strattice®) is superior to the standard technique in preventing herniation at 2 years.~   "
62519|NCT02238951|"~     The purpose of this study is to compare nurse-led care coordination for persons receiving~     cancer chemotherapy treatment incorporating mobile health technology to nurse-led care~     coordination without any mobile health enhancements.~   "
62520|NCT02238938|"~     Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can~     be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm,~     resections are usually done in a hospital setting. For the resection of large adenomas,~     different approaches can be used. The so-called piecemeal resection is done with snares, to~     cut off parts of the adenoma piece by piece until the whole adenoma is resected. This~     technique is the standard therapy, but is not required for very large adenomas, which can~     often show cell alterations that indicate cancer. Therefore these adenomas should be~     resected in one piece. This is done by the so-called en-bloc resection. For this kind of~     therapy, different endoscopic knifes are use to cut off the adenoma as a whole. Both~     resection techniques are done usually by previous injection of saline or other liquids to~     elevate the lesion from its bottom tissue.~      Although the piecemeal resection of large adenoma is the standard therapy, it shows~     recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls.~     En-bloc resections, though, are expected to have less recurrence rates but are much more~     complex to perform. They have higher complication rates especially in the West, where it has~     bee introduced only a couple of years ago.~      The data situation regarding safety and efficacy of both therapies is low. This study is the~     first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have~     influence on the logistics of future adenoma processing and patient flow.~   "
62521|NCT02238925|"~     The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization,~     assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.~      Efficacy and Safety will be assessed in all patients enrolled to the study.~   "
62522|NCT02238912|"~     this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga~     Rasayanam in Padarthamarai ( Ring worm infection )~   "
62523|NCT02238899|"~     The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All~     german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in~     the register. Object of the register is to maintain the quality of diagnostic standard by~     using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).~      Furthermore, the register should enable to continue the collection of epidemiologic data and~     biological material (tumor material, CSF, and blood) for associated studies.~   "
62524|NCT02238886|"~     The purpose of this study is to determine whether a goal directed nutritional intervention~     can reduce the convalescence period for patients undergoing radical cystectomy (RC).~      The aim is to examine the effect on quality of life of a standard nutritional strategy of~     resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery~     versus a goal-directed nutritional intervention combining oral intake and parenteral~     nutrition, in patients undergoing RC.~   "
62525|NCT02238873|"~     Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells,~     specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to~     decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer~     types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named~     filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to~     fight infection in patients undergoing chemotherapy. It has a much longer half-life than the~     parent filgrastim. It is removed from the body within the neutrophils. According to the~     American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours~     after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore~     it is cleared before and after neutropenia. Comparative low quality studies suggest that~     deferring pegfilgrastim delivery until neutrophil counts start dropping may result in~     improved its efficacy. This was further tested in a few small randomized controlled trials~     (high quality studies, considered the gold standard of studies) in different settings~     (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results.~     Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any~     salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The~     investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim~     given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in~     patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate~     whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia,~     neutrophil count, length of hospitalization, mortality, and safety.~   "
62531|NCT02238795|"~     Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is~     characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF~     is a manifestation of widespread clot formation in small blood vessels which emerges~     secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is~     dominated by symptoms of severe sepsis and multiple organ failure which are further~     aggravated by the massive skin lesions.~      At present, there are no evidence-based guidelines for the medical management of SAPF. With~     numerous therapeutic approaches in use, there are no consistent comparisons of their~     efficacy. Altered role of causal pathogens following the introduction of meningococcal and~     pneumococcal prophylactic vaccines also remains to be investigated.~      The goal of the registry is comprehensive collection and evaluation of information~     concerning the epidemiology, morbidity, therapy and outcome of SAPF.~   "
62532|NCT02238782|"~     To assess the absolute bioavailability of oral selumetinib in healthy male volunteers~   "
62533|NCT02238769|"~     18F-FluoroethylCholine (18F-FECH) is a new tracer used in PET synthesized by Nuclear Medical~     Center of Peking Union Medical College Hospital and is favored for diagnosis of primary~     brain tumor. Although 18F-FECH showed a high presence of biological distribution in liver,~     18F-FECH PET may have a higher sensitivity in diagnosis of intra- and extra-hepatic lesions~     of HCC respectively than those of 18F-FDG or 11C-acetate PET scan, and 18F-FECH PET could be~     a promising tool in diagnosis and staging, therapy selection and prognostic evaluation for~     HCC patients. However, much more cases are required to verify this theory. The purpose for~     this study is to establish the model of clinical experimental prospective study, and to~     evaluate the sensitivity, specificity and accuracy of 18F-FECH PET in diagnosis of HCC.~   "
62534|NCT02238756|"~     The purpose of this clinical trial is to investigate the safety and tolerability of IM~     administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in~     humans.~   "
62535|NCT02238743|"~     The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical~     outcome data following the completion of a hands-on proctorship training model in~     laparoscopic ventral hernia repair.~   "
62536|NCT02238730|"~     To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral~     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the~     treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral~     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.~   "
62537|NCT02238717|"~     This study will examine the activity of 2 different doses of PF-06372865 on a panel of~     evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male~     subjects.~   "
62538|NCT02238704|"~     The World Health Organization (WHO) now recommends prenatal calcium supplementation for~     prevention of preeclampsia in populations with inadequate dietary intake. This study seeks~     to compare the effect of two dosing strategies on the amount of supplement ingested by~     pregnant women and adherence to related recommendations.~   "
62539|NCT02238691|"~     Continuous positive pressure during anesthetic induction is today not routinely used partly~     a to the risk of gastric insufflation because of higher ventilatory pressures. However there~     are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The~     investigators aim to compare the risk of gastric insufflation regarding mask ventilation~     technique, with or without positive end expiratory pressure. For measurements a High~     Resolution Impedance Manometry Catheter is used.~   "
62540|NCT02238678|"~     It has been demonstrated that ligaments, both cardinal and uterosacral contain a~     considerable amount of autonomic nerve tissues. The resection of deep infiltrating~     endometriotic nodules at the level of the uterosacral ligaments or the rectovaginal space is~     supposed to damage the supplying autonomic nerve fibers of the lower urinary tract. The~     bladder receives motor and sensitive innervations from both the sympathetic fibers, most of~     which arise from the hypogastric plexuses and nerves, and the parasympathetic fibers, which~     arise from the pelvic splanchnic nerves and the inferior hypogastric plexus; therefore, even~     bladder function may be impaired in women affected by deep endometriosis.~      Very few data have been published regarding the urodynamic functional evaluation of bladder~     in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the~     postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing~     detrusor pathology.~      Since the urinary postoperative complications have a strong impact on quality of life of the~     deep endometriosis patients and often requires management (due to a poor spontaneous~     remission), it is crucial a better understanding of the problem. That will help for a more~     appropriate pre-operative counselling.~      Aims of this study are to evaluate the bladder function before and after deep endometriosis~     surgery, using standardized validated instruments and to correlate the localisation of the~     endometriosis lesion, the type/area of surgical dissection with the postoperative bladder~     function.~      This is a prospective multicenter cohort study involving the Department of General~     Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the~     Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).~      A total of 50 patients are planned to be included. The study protocol consider a~     Preoperative Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative~     specific questionnaire including obstetric, medical, and surgical history and standardized~     questions on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic~     floor) a Intraoperative Assessment (during laparoscopy, the localizations of endometriotic~     lesions recorded and identified by anatomical sites, numbers, and depth of infiltration).~     Before and 3 months after surgery a Urodynamic assessment is planned.~   "
62541|NCT02238665|"~     Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of~     pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities~     involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE)~     allows on demand in vivo characterization of architectural and cellular details during~     endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.~   "
62542|NCT02238652|"~     Improving quality of life (QoL) in residents of nursing homes:~      A cluster randomized clinical trial of efficacy - The KOSMOS study.~      COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and~     treatment, Medication review, Occupational therapy, and Safety) is a practical intervention~     aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention~     combines the most effective research results to improve staff competence and patients'~     mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.~   "
62543|NCT02238639|"~     The primary objective is to demonstrate the clinical benefits of an active strategy for the~     diagnosis and treatment of PE compared to usual care in patients with unexplained~     exacerbations of COPD who require hospital admission.~      The secondary objective is to assess the safety of an active strategy for the diagnosis and~     treatment of PE compared to usual care in patients with unexplained exacerbations of COPD~     who require hospital admission.~   "
62555|NCT02238470|"~     The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the~     risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite~     oral anticoagulation~   "
62544|NCT02238626|"~     This is a single center, randomized, double-blind, placebo-controlled, 6-month study~     designed to evaluate the safety, tolerability and clinical responsiveness of~     MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60~     subjects with ALS.~      This study will consist of two treatment arms, MN-166 and matching placebo. Randomization~     will occur in a 2:1 ratio (MN- 166: placebo).~      Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months;~     Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last~     dose.~      During treatment phase, subjects return to the clinic at Months 3 and 6 and will be~     telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new~     or concomitant medications.~      All subjects (subjects who complete the Double-blind Phase and subjects who complete the~     Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately~     2 weeks after the last dose of study drug to assess adverse event status and to document~     concomitant medications.~      Safety will be assessed by monitoring and recording all treatment-emergent adverse events~     (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs.~     Additional assessments will include regular monitoring of hematology, blood chemistry, and~     urine values, regular measurement of vital signs, ECGs, medical history, physical and~     neurological examinations.~   "
62545|NCT02238613|"~     The purpose of this study is to determine whether radioactive stents and common used plastic~     stents are effective and safety in the treatment of unresectable biliary tract cancer.~   "
62546|NCT02238587|"~     To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity~     status of the patients with head-and-neck cancer after complete treatment (including surgery~     and / or radiotherapy and/or chemotherapy)~   "
62547|NCT02238574|"~     Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a~     5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always~     preceded by precursor lesions. Treatment of these premalignant mucosal abnormalities is~     generally limited and not very inconvenient for the patient. If this precursor lesion remain~     untreated, it may develop into a malignancy of the head and neck. Extensive treatment will~     be necessary. This means loss of function of the mouth, eg chewing, speaking and swallowing.~      The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ~     hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying~     the follow up and treatment in premalignant CIN lesions, the incidence of progression to~     invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,~     there will be a place for CIN detection as a risk indicator in the diagnostic work up of~     premalignant lesions in the head and neck.~      The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA~     markers is a reliable indicator for progression to malignancy. By intensifying the~     outpatient clinic follow up and treatment in premalignant lesions, the incidence of~     progression to invasive carcinoma is expected to be significantly reduced. If this~     hypothesis is justified, there will be a place for CIN and LOH detection as a risk indicator~     in the diagnostic work up of premalignant lesions in the head and neck.~   "
62548|NCT02238561|"~     The investigators will examine the relationship between post-operative oxygen consumption~     (using non-invasive measurement technology ) and complications in patients having~     contemporary major abdominal surgery. The investigators hypothesis is that major surgery may~     trigger a physiological stress response that results in an increase in post-operative~     metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen~     delivery (DO2).~        1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2)~          using indirect calorimetry in a cohort of patients~        2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in~          the same cohort using non-invasive measures of cardiac output, oxygen saturation and~          haemoglobin (pulse wave transit time and co-oximetry techniques)~   "
62549|NCT02238548|"~     Rationale: Infections are an important worldwide cause of death, both in elderly and young~     children. Therefore, support of immunity could help to reduce the incidence of infections.~     To screen the potential of specific foods or food ingredients to support immunity, oral~     vaccination can serve as a model. In this study, oral cholera vaccination will be applied in~     human adult volunteers, and used as a model to study the support of the immune response by~     raw milk.~      Objective: To investigate whether raw milk is able to enhance the immune response as induced~     by oral cholera vaccination.~      Study design: The study is designed as a single-blind randomized controlled trial of 4~     weeks.~      Study population: Healthy subjects of 18-50 years of age.~      Intervention: Raw milk, obtained from farms that comply to the high quality requirements for~     production of raw milk, and that has been screened according to the safety criteria for raw~     milk.~   "
62550|NCT02238535|"~     To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic~     residual pulmonary hypertension.~   "
62551|NCT02238522|"~     The purpose of this study is to determine safety, tolerability, dose limiting toxicities~     (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory~     lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).~   "
62552|NCT02238509|"~     Recent clinical studies have shown that the combination of lapatinib and trastuzumab has~     superior antitumor activity compared to either single drug in both neoadjuvant and~     metastatic setting and is well tolerated. According to this evidence, the combination of~     lapatinib and trastuzumab today offers a valid chemotherapy-free option, primarily for~     patients with pre-treated HER2-positive MBC~   "
62553|NCT02238496|"~     The purpose of this study is to test the effectiveness of a drug called temsirolimus in~     combination with a drug called perifosine in treating brain tumors that have continued to~     grow after previous treatment. Temsirolimus is an intravenous drug approved by the FDA for~     treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain~     tumors. Perifosine is a pill that has not been approved by the FDA which blocks a messenger~     that tells cancer cells to grow. Research suggests that combined treatment with both drugs~     is better than either alone, and that it is reasonably safe.~   "
62554|NCT02238483|"~     The purpose of this study is to determine whether AZD7624 can reduce acute Chronic~     Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy~     with a history of frequent acute exacerbations~   "
62556|NCT02238457|"~     The sympathetic nervous system, a part of the nervous system that stimulates the heart via~     release of substances, noradrenaline and adrenaline (combined called catecholamines),~     becomes activated in people with heart failure. As these people become sicker, the nervous~     system becomes more active, causing further damage to the heart.~      Large trials have shown that Angiotensin-converting enzyme (ACE) inhibitors reduce morbidity~     and mortality in patients with heart failure. Higher doses of these drugs are more effective~     than lower doses. Studies show that ACE-inhibitors decrease catecholamine levels. This could~     be why congestive heart failure (CHF) patients taking this class of drugs show improvement~     in heart function.~      There are several ways of measuring the activity of the sympathetic nervous system. The most~     common measurement is to test the blood for catecholamine levels. This is not very reliable~     or reproducible. Microneurography is a new technique used to measure sympathetic nerve~     activity. A small electrode (comparable to an acupuncture needle) is placed in a muscle~     nerve and hooked up to a stimulator and a recorder. It produces direct recordings of~     skeletal muscle nerve traffic. Both the rate and amplitude of the burst can be measured. The~     results in this technique are highly reproducible. By using this technique we get a more~     accurate picture of how the nervous system responds to medications given to treat heart~     failure.~      Losartan (Cozaar) is an angiotensin II type 1 (AT1) receptor blocker. It blocks the binding~     of angiotensin II, a hormone that constricts blood vessels. As a result the blood vessels~     remain relaxed, leading to a reduction in the workload of the heart. Minor decreases in~     blood catecholamine levels have been reported with a low dose of this drug. The purpose of~     this study is to see whether a high dose of losartan (200 mg) has a greater effect on the~     sympathetic nervous system than a low dose of losartan (50 mg) does.~      A total of 30 participants will be recruited. Participants will be assigned to one of two~     groups: high-dose, in which subjects will receive treatment of 200 mg/day of losartan, and~     low-dose, in which subjects will receive treatment of 50 mg/day of losartan. Via~     microneurography the investigators will measure the difference in sympathetic activity in~     subjects in high-dose vs low-dose losartan. The investigators expect to see further decrease~     in sympathetic activity in high-dose group than in low-dose group.~   "
62557|NCT02238444|"~     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and~     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism~     after Laparoscopic Splenectomy.~   "
62558|NCT02238431|"~     Currently all patients that have freeze-all ICSI treatment cycles have the start of their~     FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the~     patients that have a blastocyst transfer has been maintained over time, 15% of started FET~     cycles are being cancelled because of premature luteinization, and the treatment (to~     transfer) takes approximately 89 days. The use of a Lucrin depot may reduce the number of~     cycles cancelled and reduce the treatment time to approximately 69 days. The use of no drugs~     and allowing the normal menstrual cycle to determine the time to start the FET cycle may~     suit some patients. Whether these benefits can be obtained while still maintaining the~     current FET pregnancy rate will be the main focus of the trial.~   "
62559|NCT02238418|"~     Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having~     an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and~     cardiovascular protection).~      Until recently, vitamin D repletion was defined as the minimal concentration that enables~     the prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL~     (20 nmol/L). However, most of the international experts agree to set minimal threshold of 25~     OH vitamin D serum concentration, higher than the one previously admitted, with a limit of~     20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to~     define vitamin D insufficiency.~      Recommendations for Vit D supplementation in healthy children were updated in France in~     2012. The invariable supplementation of infants and toddlers is efficient since~     deficiency-related rickets have almost disappeared; however there is very few information in~     ill children populations.~      Vit D supplementation tolerance is usually considered as good and over-dosage risks are low,~     however these studies were conducted more than 30 years ago, and as far as we know, there is~     no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of~     cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL,~     which is very rare in daily practice, toxic effects of Vit D may theoretically be observed,~     particularly hypercalcemia and hypercalciuria.~      Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to~     92% prevalence depending on the studies; it it is a risk factor for secondary~     hyperparathyroidism.~      Although international guidelines regarding the care of CKD children recommend 25 OH vitamin~     D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of~     dose and frequency of native Vit D treatment.~      Therefore, the objectives of the present study has are the following:~        -  to validate prospectively the efficacy of our service usual care for Vit D~          supplementation of children and adolescents seen in the paediatric nephrology~          department.~        -  and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol)~          on calciuria in these patients.~   "
62560|NCT02238405|"~     The primary focus of this intervention trial is to understand the effect of quitting smoking~     on TB treatment outcomes. The investigators will compare a cessation strategy based on~     guidelines recommended by the World Health Organization (WHO) and the International Union~     against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly~     observed therapy (DOT) clinics in Pakistan. The investigators study will provide~     comprehensive data towards understanding the effectiveness of these strategies for TB~     patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on~     TB treatment outcomes. These findings will guide development of effective smoking cessation~     strategies in a region with high prevalence of TB and increasing tobacco use.~   "
62561|NCT02238392|"~     This study investigates impact of adenosine versus AF inducibility and subsequent~     termination on the acute and long-term outcome of paroxysmal AF ablation.~   "
62562|NCT02238379|"~     The objective of this study is to investigate the effects of oxytocin on social behavior and~     brain activity using EEG and the event-related potential (ERP) technique. The value of EEG~     is its high temporal specificity, enabling precision in the timing of social behavior to be~     addressed. In order to elicit social responses in the human brain, a variety of social and~     emotional visual stimuli will be presented during EEG recording, namely infant and adult~     faces and houses. Brain responses after intranasal oxytocin will then be compared with~     placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We~     hypothesize that intranasal oxytocin will enhance the neural response to social stimuli~     (infant and adult faces) but not to non-social stimuli (houses).~   "
62563|NCT02238366|"~     The purpose of this study is to collect some parameters which may help to provide guidance~     on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.~   "
62564|NCT02238353|"~     Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of~     azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal~     AR. The combination formulation appeared to be superior in these patients with better~     symptomatic relief. However, objective analysis of the effect of this treatment on nasal~     mediators and/or nasal hyperreactivity has not yet been performed and would help in~     understanding the additional benefit of the combination treatment over monotherapy with~     nasal corticosteroids.~   "
62583|NCT02238158|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in long~     term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
62584|NCT02238145|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in~     the treatment of chronic obstructive airways disease under conditions of daily practice~   "
62585|NCT02238132|"~     To obtain further information on the tolerability of Atrovent® inhalets in the treatment of~     Chronic Obstructive Airways Disease under conditions of daily practice~   "
62565|NCT02238340|"~     Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for~     the patient, including significant cardiovascular and respiratory complications. Apart from~     the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the~     treatment of DAPO, have shown to be as or more effective than intravenous or epidural~     regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone~     sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)~     undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone~     metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at~     rest and effort, requirement for rescue intravenous morphine and incidence of side effects~     to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6,~     T18),and patient satisfaction.~   "
62566|NCT02238327|"~     The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic~     Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk~     factors and that persistent viral infection including residual HIV is linked to HIV COPD.~   "
62567|NCT02238314|"~     The primary objective was to evaluate the antiviral activity and safety of two regimens of~     tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in~     combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in~     multiple protease-inhibitor-experienced HIV-1 positive patients.~   "
62568|NCT02238301|"~     The purpose of this study is to evaluate the use of functional MRI in pregnant women as a~     non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy~     fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can~     detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus~     when the mother is breathing pure oxygen. This study aims hence to demonstrate the~     difference in the BOLD effect between normal feto-placental units and growth restricted~     ones.~   "
62569|NCT02238288|"~     Patients using anticoagulants present an increased risk of bleeding when subjected to oral~     surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures,~     may result in thromboembolic events, putting patients health in risk. Recent studies~     advocate the dental surgery treatment without suspending the anticoagulant therapy, since~     the values of the international normalized ratio (INR) are in acceptable therapeutic levels~     and local measurements are taken for the hemostasis control. The aim of this study is to~     compare the effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated~     to daily rinses with the drug, with routine post-surgical procedures, to control the~     post-exodontic bleeding in anticoagulated patients. Patients will be referred by the~     anticoagulation clinic of the Clementino Fraga Filho University Hospital. Once the study~     criteria is met patients will be randomly allocated into two groups and subsequently~     subjected to clinical and periodontal examination, radiographic examination and~     pre-operative periodontal therapy. Laboratory tests (partial thromboplastic time,~     prothrombin time, international normalized ratio and platelet count) will be held on the day~     of the extraction. Patients in group 1 ( EACA ) will receive a paste composed of 01~     macerated EACA tablet (500 mg), mixed with 0.9% saline solution in the alveolar socket, and~     routine post-operative care. Additionally, patients will perform oral rinses three times a~     day, on the first two post-operative days, with a solution from the macerated EACA 500mg~     tablet diluted in 2 spoons of filtered water. Patients allocated in group 2 (control) will~     receive routine post-operative care. Classification of immediate bleeding will be held by~     the professional, on the day of the surgery, immediately after the suture and twenty minutes~     later and the delayed bleeding, recorded by the patient through a daily questionnaire. The~     Statistical Package for the Social Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the~     database and the Chi-square, Kruskal-Wallis and Mann-Whitney tests will be applied to~     statistical analysis of the results.The study was approved by the ethical and research~     committee of the Clementino Fraga Filho University Hospital . All patients will sign a free~     consent and informed term.~   "
62570|NCT02238275|"~     Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice~     prescribing-conditions~   "
62571|NCT02237261|"~     The purpose of this study is to improve efficacy of treatment for patients with newly~     diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by~     autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.~   "
62572|NCT02237248|"~     The purpose of the study is to examine the changes in function and performance biomechanics~     in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis~     (AIS).~   "
62573|NCT02237235|"~     The goals of this study are to study MMFS-202-302 in a double blind, randomized,~     placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60~     patients with schizophrenia or schizoaffective disorder with stable levels of positive~     symptoms. Secondary end points will include changes in positive and negative symptoms. One~     dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to~     atypical antipsychotic drug treatment.~   "
62574|NCT02237222|"~     The aims of this project are to evaluate the psychometric properties of the German versions~     of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette~     Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years~     with a neuromuscular diagnosis.~   "
62575|NCT02238262|"~     The aim of the observational study was to supplement the data on efficacy, safety and~     tolerability of telmisartan under daily conditions in hospitals~   "
62576|NCT02238249|"~     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in~     daily clinical practice in Japanese paediatric patients with urticaria~   "
62577|NCT02238236|"~     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in~     daily clinical practice in Japanese paediatric patients with allergic rhinitis,~     eczema/dermatitis, urticaria and pruritus~   "
62578|NCT02238223|"~     Study to investigate the safety and efficacy information of Alesion® Tablet under the proper~     use in daily clinical practice after new treatment guideline for allergic rhinitis,~     bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris~     with itching~   "
62579|NCT02238210|"~     Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5~     years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from~     symptoms of rhinorrhea associated with allergies~   "
62580|NCT02238197|"~     To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml~     inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under~     conditions of daily practice~   "
62581|NCT02238184|"~     To obtain further information on the prescribing pattern and therapeutic long term value in~     patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under~     conditions of daily practice~   "
62582|NCT02238171|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the~     treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
62587|NCT02238106|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,~     administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene~     (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,~     administered as the xinafoate salt) following single dose inhalation in patients with COPD.~     A hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering~     effect.~      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation~     powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate~     delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical~     forms and/or doses.~   "
62588|NCT02238093|"~     Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients.~     Recently, its prevalence is rising. There are several different clinical presentations of~     this syndrome. It has a high rate of morbidity and mortality.~      The purpose of this study is to find the connection between the heart pathology and its~     effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these~     patients, and hopefully, aid in increasing their quality of life, and decrease their~     morbidity and mortality.~   "
62589|NCT02238080|"~     This observational, multi-center, open-label, prospective study will evaluate the~     relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and~     methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease~     (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene~     glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene~     glycol-epoetin beta.~   "
62590|NCT02238067|"~     This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim~     is to better understand the current therapy pattern for anemia in CKD treated with~     erythropoiesis-stimulating agents (ESAs) and not on-dialysis participant population in~     Israel. Participating physicians will be requested to interview eligible participants with~     CKD not on dialysis and to complete for them a satisfaction survey for anemia treatment. The~     survey will be completed twice, once at study start and once at six months' follow-up.~   "
62591|NCT02238054|"~     Observational Study, French, prospective, multicenter rated using intravascular prosthesis~     ABSORB BVS.~      ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all~     procedures for coronary angioplasty with implantation of at least one BVS with a clinical~     follow-up of all patients implanted with ABSORB BVS. This national observatory will collect~     all the events related to product and / or to procedure~   "
62592|NCT02238041|"~     The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear~     CGM System.~   "
62593|NCT02238028|"~     An intervention study to assess the short-term cardiovascular effects of reducing personal~     air pollution exposure by wearing particulate filtering respirators.~   "
62594|NCT02238015|"~     To compare tear film differences between surgical eyes and nonsurgical eyes in patients who~     had cataract surgery by phacoemulsification in one eye.~   "
62595|NCT02238002|"~     To investigate changes in anterior chamber angle configuration after phacoemulsification and~     intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).~   "
62596|NCT02237989|"~     The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on~     joint pain and function and its effects on urinary biological markers related to cartilage~     degeneration in patients with knee osteoarthritis.~   "
62597|NCT02237976|"~     The proposed study is designed to utilize a self-hypnosis training program for patients~     awaiting lung transplantation. This technique can increase their well being, particularly by~     decreasing postoperative pain.~   "
62598|NCT02237963|"~     The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on~     the surgical approach. The posterolateral approach is compared to the axillary approach~     especially in term of development of a chronic pain.~   "
62599|NCT02237950|"~     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on~     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in~     women with a history of recurrent BV.~   "
62600|NCT02237937|"~     The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation~     strategy within 28 days of treatment with approved antidepressants that are known substrates~     of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1~     gene.~      Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved~     antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the~     blood-brain barrier expressed by the ABCB1 gene.~   "
62601|NCT02237924|"~     A total of 120 patients with pathologically confirmed locally advanced low-risk~     nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60~     patients in each group. One group was treated with intensity-modulated radiation therapy~     (IMRT) combined with Endostar and the other group was treated with IMRT combined with~     concurrent chemotherapy. The short term efficacy and the toxic and side effects of these~     treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free~     survival of patients were analyzed. Our data may provide an alternative option for the~     treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low~     toxicity.~   "
62602|NCT02237911|"~     Although total knee replacement (TKR) improves pain in numerous patients, it does not~     resolve many of the substantial functional limitations and physical inactivity that existed~     for a long time prior to the surgery. Exercise is an intervention that could improve these~     long-term limitations. To promote these improvements, exercise should be implemented at~     later stage post TKR when patients can tolerate doses of exercise sufficiently high to~     promote substantial changes. To date, we just don't have enough good research to tell us~     which type of exercise works best for which patients and under which circumstances at later~     stage post TKR. This research study will provide evidence for recommended interventions~     during the later stage post TKR. The specific research questions are: (1) How do group~     exercise in the community and individual exercise in rehabilitation clinic compare with~     usual medical care on physical function and activity outcomes? (2) Who are the patients most~     likely to respond to each exercise intervention? (3) Are the approaches safe?~   "
62604|NCT02237885|"~     Up to half of military veterans with traumatic brain injury (TBI) also suffer from~     co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic~     pain, one of the most common health complaints among U.S. veterans who served in Operation~     Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn~     (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate~     that veterans perceive barriers to traditional mental health treatments. Little research~     exists regarding non-pharmacological, technology-based interventions designed to reduce pain~     in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG~     biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain~     in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of~     using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI.~     Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG~     brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides~     neurofeedback to induce relaxation). Veterans are taught how to use these together to do~     neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary~     data, we hypothesize that participants will show high levels of adherence to the NeuroSky +~     Mobile Neurofeedback intervention for the 3-month study duration and that participants will~     show statistically significant reduction in pain symptoms at 3 months compared to baseline.~     Given links between pain and other outcomes in veterans, we will also explore effects on~     drug abuse, violence, and suicidality. When the research is complete, the field will be~     changed because we will know whether new technology reading EEG brainwaves can be used to~     treat symptoms among individuals suffering from chronic pain. We will also know whether~     neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to~     reduce pain and related outcomes. If this program of research is successful, its impact will~     be to shift approaches to managing pain in clinical practice, for both veterans and~     civilians~   "
62605|NCT02237872|"~     The primary goal of this study is to assess the accuracy of conventional fat fraction proton~     MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using FDG-PET as~     gold standard.~      In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be~     performed on a combined PET/MRI scanner under mild cold condition.~   "
62606|NCT02237859|"~     We are doing this research study to determine if taking vancomycin in addition to a~     broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium~     difficile infection.~   "
62607|NCT02237846|"~     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once~     per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect~     in osteoarthritis (OA) patients.~   "
62608|NCT02237833|"~     The purpose of this study is to reveal if higher doses of vasopressors in septic shock~     patients correlates with cerebral vasoconstriction and lower cerebral oximetry.~   "
62609|NCT02237820|"~     This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with~     negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of~     HF patients hospitalized with exacerbation of COPD. The study may provide important data~     regarding a simple but potentially robust intervention among large patient population with~     high rates of hospital admissions.~   "
62610|NCT02237807|"~     The purpose of this study is to assess the bioequivalence of the investigational TEST~     product with the marketed REFERENCE products by measurement of Plasma concentrations of~     Erythromycylamine in plasma and calculation of the bioequivalence parameters from those~     measurements followed by ANOVA and 90% confidence interval statistical evaluation.~   "
62611|NCT02237794|"~     The purpose of this study is to determine the effect of medical treatment on longitudinal~     myocardial function. Patients who have been hospitalized for reasons other than heart~     disease will be examined with Transthoracic Cardiography before and after medical treatment~     to determine change in myocardial function.~   "
62612|NCT02237781|"~     Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable~     levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF~     about the effect of ovarian stimulation on the levels of AMH due to the increasing size of~     follicles and chances of success of the method.~   "
62613|NCT02237768|"~     The purpose of this study is to assess the bioequivalence of the investigational TEST~     product with the marketed REFERENCE products by measurement of Plasma concentrations of~     Erythromycylamine and calculation of the bioequivalence parameters from those measurements~     followed by ANOVA and 90% confidence interval statistical evaluation.~   "
62614|NCT02237755|"~     Coadministration of various drugs used for ovarian stimulation can increase the efficiency~     of IVF especially in poor responders. The investigators hypothesize that ovarian response of~     those patients could improve by using combination of clomiphene citrate with gonadotropins~     in infertile women with poor response to gonadotrophin administration only.~   "
62615|NCT02237742|"~     To determine how the body reacts to a low dose of PF‑06427878 when given in a vein over 30~     minutes to healthy, adult, males.~   "
62616|NCT02237729|"~     This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,~     single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and~     EU administered subcutaneously (SC) to healthy male and female volunteers~   "
62617|NCT02237716|"~     The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base~     excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid~     infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown~     in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min~     and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two~     variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no~     significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly~     increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which~     remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed~     a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min~     and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a~     significant decrease between -20 min and 0 min and a significant increase between 0 min and~     60 min (P < 0.001), which returned to the baseline after 20 min.~   "
62628|NCT02237573|"~     In France, patients with benign viral infections (ie: gastro enteritis and/or~     rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although~     there is evidence that these medicines are not efficient.~      We hypothesize that patients could be reassured by health advices, especially if they are~     written. In addition, we believe that doctors would feel less guilty for not prescribing~     drugs if they could hand written consultation reports to patients, in these situations.~      We aim to assess the impact of handing to patients with viral gastroenteritis or upper~     respiratory tract infections, a copy of the consultation report on their medicine~     consumption.~   "
62618|NCT02237703|"~     This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors~     (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD).~     The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD,~     N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma~     exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI)~     and one PET study. The investigators will also carefully document trauma history, and~     collect behavioral and neuroendocrine measures to provide a more integrative view on the~     neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater~     carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than~     control populations in an a priori defined PTSD circuit.~   "
62619|NCT02237690|"~     This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment,~     two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference~     (R) formulations of doxorubicin hydrochloride liposome injection in female patients with~     ovarian cancer.~      Each patient will be randomized to one of two treatment sequences (RT or TR) according to a~     randomization scheme prepared prior to the start of the trial.There will be at least 4-week~     apart between each single-dose administration. Serial blood samples for determination of~     free doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK~     analysis will be obtained in each cycle.~      The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products~     of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate~     bioequivalence.~   "
62620|NCT02237677|"~     The objective of the proposed translational study is to test a model, based upon basic~     science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB)~     and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1~     (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators~     propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral~     response to the stressor is associated with an upregulation of the CB1 receptors and~     insufficient glucocorticoid signaling.~   "
62621|NCT02237664|"~     Thoracic surgery is commonly associated with severe postoperative pain and marked impairment~     of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is~     assumed to result in better quality of life and less postoperative pain compared with~     standard open thoracotomy, other investigators have reported comparable patient-reported~     physical component summary and pain scores after VATS and thoracotomy during the first 12~     months after lung resection.2 That study was non-randomized and 41% of the included patients~     did not complete the follow-up period.2 VATS has recently been increasing in popularity as a~     fast-track surgery with potential enhanced recovery after surgery.~      Variety of approaches exist to manage pain after thoracotomy which could attenuate~     post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many~     decades to be the best method of pain relief after major thoracic surgery. In previous~     meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade~     (PVB) has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients~     undergoing thoracotomy.~      Additionally, PVB has a better side-effect profile, lower rates of failed block and is~     associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to~     enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7~      Patient-controlled analgesia (PCA) has been advocated as a favourable model for~     postoperative analgesia, that allows a perfect match between intensity of pain and analgesic~     delivery, improves the quality of analgesia and decreases the cumulative analgesic~     consumption. Furthermore, the introduction of patient-controlled epidural analgesia (PCEA)~     with background infusion during labour gave patients a sense of control over their~     analgesia, reduced the total dose of local anesthetic administered, and had less motor block~     than those who receive continuous epidural analgesia.8-9Patient-controlled epidural~     analgesia (PCEA) has become increasingly popular for pain control after thoracotomy.10-12 In~     a previous preliminary study, McElwain et al.13 have reported satisfactory analgesia after~     breast cancer surgery with the use of PC-PVB, using either 15-min or 30-min lockout, that~     study did not include a comparative arm with a continuous paravertebral infusion.~     Furthermore, Abou Zeid et al. have reported comparable analgesia after thoracic surgery with~     the use of either patient-controlled PVB had with the use of intrathecal morphine, that~     study was not controlled and included few patients.14~      The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of~     postoperative analgesia and pulmonary function after VATS has not yet been studied.~   "
62622|NCT02237651|"~     The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™~     Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical~     nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl~     Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.~   "
62623|NCT02237638|"~     The primary objectives of this study are to investigate the safety and tolerability profile~     of the therapeutic vaccine hVEGF26-104/RFASE and to determine the effective dose of~     hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0~     pg/mL.~   "
62624|NCT02237625|"~     Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective~     bone and teeth mineralization caused by mutations of the ALPL gene, which encodes for the~     tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and~     bone alkaline phosphatase levels. To date, over 250 different mutations in the gene encoding~     TNSALP have been associated with HPP. Clinically, the loss of TNSALP function results in~     progressive skeletal impact as well as progressive impact on all other major organ systems.~     It clinically manifests as rickets in infants and children and osteomalacia at all ages. The~     severe form of the disease has been estimated to have a prevalence of about 1 in every~     100,000 live births.~   "
62625|NCT02237612|"~     This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging~     (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph~     nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI,~     may be a less invasive way of predicting the stage and grade of prostate cancer.~   "
62626|NCT02237599|"~     This study hypothesizes that an automated device using small electronic impulses can detect~     nerve impairment in unconscious patients.~   "
62627|NCT02237586|"~     The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ)~     via intravenous (IV) administration in three groups with different malaria immunity-status:~        1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)~        2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)~        3. Adults without previous malaria episodes without sickle cell trait (HbAA)~      Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear~     positivity after challenge will be assessed. If in any of the groups with a history of~     lifelong malaria exposure, 50% or less of individuals become thick blood smear positive~     during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to~     12,800 PfSPZ in this group.~   "
62650|NCT02237196|"~     This trial will test whether a novel therapeutic approach, cat immunotherapy combined with~     an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal~     lymphopoietin] antibody being co-developed by Amgen and MedImmune) can lead to lasting~     tolerance to cat allergen.The objective of the study is to determine whether one year of~     immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.~   "
62629|NCT02237560|"~     The purpose of this study is to clarify the benefits to brain health and thinking processes~     that result from different forms of exercise. This study will examine the effectiveness of~     cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with~     MCI, and compare this with the individual cognitive, behavioral, and physiological effects~     of physical and mental exercise alone. The Investigators hypothesis that cognitive benefit~     will be greatest for combined aerobic and cognitive exercise compared to physical and mental~     exercise alone.~   "
62630|NCT02237547|"~     Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear~     Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected~     intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI)~     patients.~   "
62631|NCT02237534|"~     The purpose of this study is to compare the effect of lanthanum carbonate and calcium~     carbonate on the progression of coronary calcification and vascular endothelial dysfunction.~   "
62632|NCT02237521|"~     Patients with end-stage renal disease (ESRD) have a high prevalence of impaired glucose~     metabolism. The pathophysiological cause is uncertain, but disturbances in the secretion,~     elimination and effect of glucagon, insulin and the two incretin hormones glucagon-like~     peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), probably play~     important roles. Our research group has previously found that dialysis patients without type~     2 diabetes mellitus (T2DM) have a reduced incretin effect and an inability to suppress~     glucagon after a meal - two early pathophysiological characteristics of patients with T2DM~     and normal kidney function.~      The aim of the project is to provide a detailed description of the mechanisms underlying the~     (patho)physiological effects of the incretin hormones in patients with ESRD. We plan to~     investigate the above mentioned disturbances during fasting and hyperglycaemic conditions~     using incretin infusions during glucose clamping. Furthermore, stable isotopic tracers will~     be used to determine the effect of the incretin hormones on the endogenous glucose handling.~      We hypothesise that the effects of the incretin hormones in ESRD will be reduced in respect~     to healthy control subjects.~   "
62633|NCT02237508|"~     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in~     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence~     of the two products. Namely the study will compare the total systemic bioavailability (as an~     indicator of safety), and it will compare the pulmonary bioavailability (as a possible~     surrogate indicator of efficacy). This study will be performed in healthy subjects.~   "
62634|NCT02237495|"~     Cardiac surgery is associated with a high risk of cardiovascular and other complications.~     The investigators hypothesized that perioperative infusion of dexmedetomidine may reduce the~     incidence of complications and mortality following cardiovascular surgery.~   "
62635|NCT02237482|"~     This study is intended to compare the proximal migration of the tantalum design (TM) with a~     cemented cup used in conjunction with bone allografting in cases with major bone loss. A~     group of patients with good periacetabular bone stock are included to analyse the~     differences between the tantalum and titanium design regarding risk of loosening and~     differences in clinical outcome measures. Radiostereometry (RSA) is used to accurately~     measure migration and rotation of the revision cups.~   "
62636|NCT02237469|"~     The study purpose is to evaluate whether or not clinical characteristics of women with~     breast cancer can predict which position for radiation treatment, prone or supine, will be~     associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation~     dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed~     dose to tumor bed and ipsilateral breast.~   "
62637|NCT02237456|"~     The purpose of this study is to compare optical coherence tomography (OCT) scans performed~     in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and~     after implantation of stents or bioresorbable scaffolds.~   "
62638|NCT02237443|"~     Anesthesia providers are taught to test that they can properly ventilate a patient's lungs~     before administering a neuromuscular blocking drug (NMBD), rendering the patient apneic.~     This is a traditional teaching, not based on empirical evidence. The investigators primary~     hypothesis is that ventilation after the administration of NMBDs is non-inferior with that~     before their administration with respect to the composite safety endpoint of inadequate~     (MVi) and dead-space only (Vds) ventilation.~   "
62639|NCT02237430|"~     Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in~     the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.~   "
62640|NCT02237417|"~     This is a Phase 4, randomized, open-label, parallel group study designed to assess the~     clinical and biological effects of 12 months of treatment with long acting intramuscular~     (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on~     magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral~     antipsychotic medications and compared with a healthy control group.~      It is hypothesized that improved treatment compliance will lead to fewer white matter~     changes in the brain. Fewer white matter changes will be demonstrated via neuroimaging as~     increased FA and BPF values in the prefrontal region, and an increase in metabolites in a~     voxel centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim~     of this study is to examine the structural and metabolic effects of aripiprazole (Abilify®)~     once monthly in patients with schizophrenia using MRI techniques and to examine these~     effects in association with cognitive and clinical measures.~   "
62641|NCT02237404|"~     The purpose of this research is to estimate the outcomes in health and cost of the follow-up~     of patients with pacemakers.~      The initial hypothesize of this study is that remote monitoring of pacemaker will show a~     best relation of outcomes in costs and effectiveness than the conventional follow-up in~     hospital.~   "
62651|NCT02237183|"~     This randomized phase I trial studies the side effects and best dose of iloprost compared~     with a placebo in preventing lung cancer in former smokers. Chemoprevention is the use of~     drugs to keep cancer from forming or coming back. Inhaled iloprost may help prevent lung~     cancer from forming in patients who used to smoke and who have been found to have abnormal~     cells in their mucus.~   "
62652|NCT02237170|"~     The purpose of this protocol is perform comprehensive immune monitoring studies in patients~     with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better~     understand the mechanism of action of this treatment.~   "
62642|NCT02237391|"~     While significant advances in pain management have occurred in the last 20 years, the~     majority of patients with chronic pain (CP) are unable to access evidence-based treatment at~     either the primary or tertiary care level.~      Moreover, research has shown that unrelieved CP and the lack of available expertise~     contribute to emergency department (ED) visits and hospital admissions. At The Ottawa~     Hospital (TOH), close to 18,000 ED visits per year are related to CP (12.9%). Among high~     frequency visitors (HFV; >= 8 visits per year), a small number of patients with CP use an~     inordinate amount of acute care resources. The investigators study will use a randomized~     controlled (RCT) design to conduct a pilot evaluation of the impact of a Complex~     Interdisciplinary Pain Assessment Program (CIPAP) linked with primary care physicians (PCP)~     compared to a treatment as usual (TAU) control arm.~      The investigators hypothesis is that implementing a CIPAP will increase health care value~     through improved patient outcomes and reduced costs in HFV with chronic pain (CP-HFV). The~     investigators believe that a CIPAP will provide CP-HFV patients long-term pain management~     solutions, ED visits for CP will be reduced, and hospital admissions for CP will be~     prevented. This pilot RCT study will inform a larger-scale RCT study to be conducted in the~     future.~   "
62643|NCT02237378|"~     Right ventricular (RV) failure is the leading cause of death in pulmonary arterial~     hypertension. (PAH) Right ventricular ejection fraction is one of the most important~     predictors of prognosis in heart failure patients regardless of cause. It is estimated that~     30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right~     ventricular dysfunction and up to 70% of these patients will have significant pulmonary~     hypertension (PH), both of which are related to much worse prognosis. Right ventricular~     failure is becoming an increasingly prevalent and significant cause of morbidity in patients~     with left heart disease. Despite the significance of RV function to survival, there are no~     therapies available that directly or selectively improve RV function.~      The overall theme of this research project is to evaluate the mechanisms that contribute to~     the cause of right heart failure. This small study is designed to look at the role of heart~     and lung metabolism and pulmonary hypertension as they relate to the development of right~     heart failure in cardiovascular disease.(PH-LHD)~   "
62644|NCT02237365|"~     Tuberculous meningitis is a severe brain infection which often causes disability and death~     even when treated with the best available treatment. Aspirin is a type of anti-inflammation~     drug which can reduce the inflammatory response in brains of patients with tuberculous~     meningitis, and therefore may decrease some of the most severe outcomes. This study compares~     the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the~     standard treatment to see if aspirin is safe and helpful in reducing disability and death~     from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days~     and followed up while on standard treatment for 8 months.~   "
62645|NCT02237352|"~     The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of~     diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN)~     which is the largest single cause of end-stage renal disease and dialysis requirement. In~     South America the prevalence of DM and chronic kidney disease has increased, and great~     disparity exists among countries in regards to access to the dialysis treatment. It has been~     considerate that Hispanic origin increases the risk for DM. The South Americans have~     distinctive habits, culture, environment, behavior and genetic background and the factors~     involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis~     (pathologic generation of the new blood vessels) and extracellular matrix expansion have~     been described. The vascular endothelial growth factor A (VEGF) has been linked to~     angiogenesis, but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly~     through VEGF receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in~     kidney. Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the~     tenascin C/AVB3 complex have also been linked to angiogenesis, however their roles have not~     been unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C~     play an important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of~     this study is to characterize social, environmental and biological factors implicated in the~     DN in Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of~     the DN. Investigators propose to study factors involved in DN in diabetic and non-diabetic~     adults from general population, with and without DN. In a single time investigators will~     evaluate demographics data, habits, personal and family history through a survey.~     Investigators will measure anthropometrics parameters and blood pressure; investigators will~     quantify blood glucose, glycosylated hemoglobin A1c and proteinuria. In addition~     investigators will examine the role of tenascin C and VEGF signaling by analyzing paraffin~     embedded kidney tissue, plasma and urine samples. Characterizing the factors involved in the~     DN from Hispanic people is key to establish adequate strategies of prevention, diagnosis and~     treatment in this population. Furthermore elucidating the role of proteins involved in DN~     may offer valuable tools for the development of new treatments.~   "
62646|NCT02237339|"~     The presence of Left ventricular hypertrophy (LVH) confers high cardiovascular risk in~     hypertensive patients. LVH remains highly prevalent even when blood pressure (BP) is~     controlled. There is increasing evidence that a major non-haemodynamic contributor to LVH is~     oxidative stress. Allopurinol is known to markedly reduce oxidative stress.~      This pragmatic randomised double blind placebo controlled trial will examine whether~     allopurinol (300 mg bd) regresses LV mass as assessed by cardiac magnetic resonance (CMR) in~     66 patients with treated hypertension but who have persisting LVH.~      Endothelial and vascular function will also be assessed via flow mediated dilatation (FMD)~     and pulse wave analysis respectively (PWA) and plasma biomarkers of oxidative stress will be~     measured. The treatment (allopurinol or placebo) will last 12 months.~   "
62647|NCT02237326|"~     The clinical trial is part of a larger study to evaluate the safety and efficacy of~     screening techniques for cervical cancer among HIV-infected women. The investigators~     randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or~     Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and~     treatment decisions were based on the colposcopy exam done at the study visit. The~     investigators then compared outcomes between the two groups to assess the test~     characteristics of both VIA and VILI.~   "
62648|NCT02237313|"~     The bullous pemphigoid treatment is based on corticosteroids continued for several years.~     Pemphigus causes some patients a psychological impact and sometimes major vulnerability that~     can occur not only at diagnosis but also at later stages of disease progression. Our~     hypothesis is that these episodes of vulnerability may be under four kinds of factors that~     may be connected to the plurality of the history of these patients, and the resources they~     can mobilize throughout this experience, generating inequality in management and work~     around the disease.~   "
62649|NCT02237209|"~     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children~     around the world. This study will evaluate the safety and immune response to an RSV vaccine~     in RSV-seronegative infants and children.~      This study is a companion study to CIR 291.~   "
62653|NCT02237157|"~     A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the~     pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.~   "
62654|NCT02237144|"~     This is a randomized control trial in two zones of Bangladesh (north and south). Treatment~     is assigned at the village level where treatments are: cash transfers (north and south);~     cash transfers + nutrition behavior communication change (north only); food transfers (north~     and south); food transfers + nutrition behavior communication change (south only); food-cash~     split (north and south); and controls (north and south). Within treatment localities, women~     living in very poor households are targeted to receive benefits for two years.~   "
62655|NCT02237131|"~     To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual~     cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas~     following fertility-sparing surgery.~   "
62656|NCT02237118|"~     To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute~     wound management.~   "
62657|NCT02237105|"~     This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the~     outcome of spinal surgery.~      The goal of this treatment is to change the coping style, thoughts, behavior and adaptive~     perception of the patient, and to replace them with an adaptive style.~      The patients in this study will be randomly divided into two groups. One group will undergo~     Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a~     control group, and will not have any psychological intervention.~   "
62658|NCT02237092|"~     It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the~     volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute~     to the development of more high spinal block.~   "
62659|NCT02237079|"~     The goal of this pilot clinical study is to perform a randomized placebo-controlled study to~     assess the beneficial effect of a 3 month-treatment with DUAVEE vs. placebo on glucose~     homeostasis and body composition in 20 post-menopausal women. The recruitment will be~     performed at Tulane Health Sciences Center.~   "
62660|NCT02237066|"~     The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous~     Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence~     Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular~     response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with~     the primary endpoint being luminal gain assessed by OCT lumen volume measurements.~   "
62661|NCT02237053|"~     The purpose of this study is to collect data to help researchers better understand the~     effects of glucagon on the amount of calories burned.~   "
62662|NCT02237040|"~     This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar~     fractures in pediatrics treated simply with a mandibular manipulation technique accompanied~     by mouth opening training.~   "
62663|NCT02237027|"~     In the last few years, early treatment of HIV-infected individuals, or treatment as~     prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative~     people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising~     biological preventive interventions to tackle the HIV pandemic within the framework of~     combination prevention, a multi-component strategy that has been promoted for the last five~     years. In West Africa, the evidence strongly suggests that female sex workers (FSWs)~     contribute very disproportionally to the HIV spread. This is why the investigators propose~     this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV~     prevention research in the sex work milieu for the last two decades.~      After a run-in phase for community preparedness and the development of a specific education~     program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP~     component of the project (these women will receive a first-line antiretroviral treatment~     (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component~     (these women will receive Truvada®). The recruitment period will last for one year, followed~     by an additional one year of follow-up, for a total follow-up period varying between 12 and~     24 months, depending on when a given woman is recruited in the study. During follow-up~     visits every three months, the investigators will closely monitor treatment adherence and~     changes in sexual behaviour, including the use of viral load testing among TasP participants~     and Truvada® plasma level testing for PrEP participants, as well as detection of~     prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants.~      The investigators will evaluate the feasibility of TasP and PrEP through a set of~     indicators, including uptake, coverage, adherence, condom migration, occurrence of side~     effects and development of drug resistance, whereas mathematical modeling will be used to~     predict the potential impact of both interventions in the sex work milieu and the general~     population, based on the actual set of indicators observed. The study will be completed by~     an economic evaluation of the interventions and a cost-effectiveness analysis.~      Finally, the investigators will disseminate the results to the study population and to the~     Beninese health authorities and ensure the broad implementation of these interventions in~     Benin if the demonstration project shows that they are feasible and relevant.~   "
62664|NCT02237014|"~     Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen~     saturation, but the gold standard for arterial oxygen saturation is co-oximeter which~     requires an arterial blood sample. The purpose of this research study is to determine the~     accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the~     study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against~     co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low~     oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic~     interventions (including surgery and cardiac catheterizations) based solely on peripheral~     oximetry can be delayed and or inadequate. By doing this study the investigators will be~     able to establish correct limits of peripheral pulse oximeter when using the standard and~     the study sensors.~   "
62665|NCT02237001|"~     Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used~     suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the~     repair, by assessing the re-operation rate, and by assessing improvements in knee pain and~     knee function.~   "
62666|NCT02236988|"~     To study how the body absorbs apremilast, and how this absorption is affected when the drug~     is given as different formulations. Blood samples will be taken to look at the amount of~     study drug in the blood to determine how much apremilast is absorbed by the body. This study~     is beng done to iddentify the best tablet formulation (preparation) of apremilast.~   "
62667|NCT02236975|"~     Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus~     Resolute Integrity conducted in approximately 14 interventional cardiology centers in The~     Netherlands, Belgium, Spain and Portugal.~      Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients~     will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at~     baseline (pre- and post-procedure) and at 9 months follow-up.~   "
62688|NCT02236702|"~     The purpose of this study is to use positron emission tomography (PET) imaging to measure~     the activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed~     individuals.~   "
70965|NCT02128477|"~     Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac~     patients. This study thoughts to prospectively validate the prognostic value of PRD in~     post-infarction patients.~   "
62668|NCT02236962|"~     Obesity is epidemic in Australia, and current preventative strategies have had limited~     success in alleviating this health crisis. While numerous options are available for~     treatment of obesity, most do not result in sustained weight reduction. Obesity results from~     an imbalance between energy intake and expenditure, therefore new methods that correct this~     imbalance are essential for effective long-term treatment. Rodent studies show that brown~     adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore~     targeting BAT to increase its activity (energy burning rate) and quantity in humans is~     potentially a powerful tool for the treatment of obesity and related diseases. BAT has only~     recently been irrefutably identified in adult humans therefore little is known about how it~     functions in humans.~   "
62669|NCT02236949|"~     The purpose of this research study is to evaluate the effectiveness of short refresher~     sessions. Pain Practice Change Boosters given at regular intervals to sustain improved~     pain process (assessment and management) and clinical outcomes (pain intensity) achieved~     during a 15 month knowledge translation intervention, Evidence-based Practice for Improving~     Quality (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that~     affect that sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the~     effectiveness of the EPIQ intervention in 32 hospital units (4 units at each hospital site).~     16 hospital units were allocated to the intervention group and 16 units continued with~     standard care. The current study focuses on the 16 hospital units that implemented the EPIQ~     intervention only.~   "
62670|NCT02236936|"~     Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and~     Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result~     in higher treatment related toxicity and discontinuation of a potential curative treatment.~     Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional~     (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination~     with Cetuximab (E) or Cisplatin (P).~   "
62671|NCT02236923|"~     That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter~     length of stay in patients undergoing repair of aortic dissection, after adjusting for~     seasonal effects, demographics and cardiovascular risk factors.~   "
62672|NCT02236910|"~     Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as~     being effective in controlling symptoms and increase quality of life; induce stable disease~     and extend progression free survival; induce a (good) partial remission and induce a~     complete remission in patients with a somatostatin receptor positive tumour.~      The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression~     free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE,~     and the quality of life of the patients treated with Lu-DOTA-TATE.~   "
62673|NCT02236897|"~     This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and~     monitoring progression of ALS, based on a well established basic science pathway, published~     human autopsy data, preliminary data in ALS mutant mice, and our recently published data~     using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in~     healthy human volunteers.~   "
62674|NCT02236884|"~     During the past three years, a revolutionized radical surgical approach for rectal cancer~     (down to up TME  approach or transanal TME (TaTME)approach, which is opposite to the~     conventional approach) has emerged and it is a concept that combines natural orifice~     transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative~     intent. The feasibility, safety and reproducibility of it were first demonstrated in swine~     survival experiments and subsequently in human cadaver series, and then it was successfully~     applied to human patients in few centers around the world, most of which were performed with~     assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without~     conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases~     were more limited. In the initial stage, our group has successfully performed this no-scar~     transanal TME in a series of human cadavers with satisfactory outcome. Hence the~     investigators conduct this study, looking to see if this pure transanal NOTES~     investigational procedure is a safe and effective approach to radically remove rectal cancer~     of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and~     better function and life quality when gaining the best cosmetic effect.~   "
62675|NCT02236871|"~     The final stages in the development of peak bone mass (PBM) reside in late adolescence or~     early adulthood and are critical in the achievement of bone health. Optimization of PBM and~     maintenance of bone mineral density (BMD) are the best population health strategies in the~     primary prevention of osteoporosis. Diet and activity are key lifestyle factors in the~     primary prevention of osteoporosis as recognized in Canada's Food and Activity Guides.~     Dietary Reference Intakes are evidence-based regarding nutrition and bone health with a~     focus on calcium and vitamin D; yet the Food Guide and health behaviors are reliant on~     actual foods. The number of recommended servings of milk and alternatives varies by age with~     average intakes estimated to be below targets for all Canadians > 9 y of age. This is~     especially concerning during development of PBM. Therefore, the global objective is to~     generate high-level evidence that dietary intervention with milk and milk products will~     enhance PBM in young men and women and maintenance of BMD in their parents.~      The primary objective is to demonstrate in healthy young men and women (14-18.9 y at~     baseline) with habitually low usual milk and milk product intakes that intervention with~     greater milk and milk product consumption improves lumbar spine BMD in a dose-response~     manner over 2 y (while accounting for body size, physical activity, demographics and age).~     Healthy young men and women will be recruited and screened for usual intake of milk and milk~     products. Those with low intakes < 2 servings of milk or milk products will be randomized~     (stratified by sex and age) to 1 of 3 groups for the RCT (n=10090/group): maintain usual low~     intakes (<1 serving), improved intakes (average of 2 servings/d) or recommended intakes (≥3~     servings/d) of milk and milk products. A manualized motivational interviewing framework will~     be used for the interventions. Those meeting recommendations at screening will form a~     longitudinal cohort for 2 y. Key measurements include baseline and yearly assessment of BMD~     at multiple sites plus interim assessment of general health, anthropometry, dietary intakes,~     physical activity and biomarkers of calcium homeostasis; and in the young adults bone~     metabolism.~   "
62698|NCT02236572|"~     The purpose of this study is to see whether adding everolimus to hormone treatment before~     breast surgery will increase the chances of shrinking the breast cancer in those patients~     with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or~     less), compared to prior experience with hormone therapy alone. Everolimus is a drug~     currently approved for use by the United States Food and Drug administration (FDA) for the~     treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is~     considered investigational for non-metastatic breast cancer patients.~   "
62784|NCT02235454|"~     The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software~     for spectral domain optical coherence tomography (SDOCT) and if this software is superior to~     the conventional one that is currently used for SDOCT.~   "
62676|NCT02236858|"~     Objectives (include all primary and secondary objectives)~      Specific Aim #1: To determine whether an air cleaner intervention to improve home air~     quality will improve respiratory symptoms, quality of life, lung function and reduce risk of~     exacerbations in former smokers with COPD.~      Hypothesis: An intervention using HEPA and carbon filter air cleaners in homes of former~     smokers with COPD will improve respiratory symptoms, quality of life, and lung function and~     reduce risk of COPD exacerbations compared with placebo (sham air cleaners).~      Specific Aim #2: To determine whether an air cleaner intervention to improve home air~     quality will be associated with intermediate outcome measures known to be linked with long~     term outcomes in COPD, including airway and systemic markers of inflammation and oxidative~     stress, in former smokers with COPD.~      Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers~     smokers with COPD will be associated with lower levels of markers of inflammation and~     oxidative stress known to be associated with adverse outcomes in patients with COPD.~   "
62677|NCT02236845|"~     The study will assess the safety, tolerability and feasibility of Lacrima investigational~     medical device vs. sham device in adult patients with chronic Insomnia~   "
62678|NCT02236832|"~     Frontal patients are impaired in categorisation and analogical reasoning tasks, and~     different functional imaging studies from our group have shown the involvement of the~     prefrontal cortex in categorisation and analogy tasks. The aim of this project is to test~     our hypotheses about the role of the prefrontal cortex in explicit and implicit~     categorisation and analogy tasks.~   "
62679|NCT02236819|"~     There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA)~     across Europe. The likelihood of attempted resuscitation also varies. To better understand~     the factors that contribute to variation, more data on incidence, management and outcomes~     from OHCA is required. A European, multi-centre study provides the opportunity to uncover~     differences throughout Europe and may help find explanations for these differences. Results~     may also have potential to support the development of quality benchmarking between European~     Emergency Medical Services (EMS).~      This prospective European study will involve 27 different countries. It provides a common~     Utstein-based dataset, data collection methodology and a common data collection period for~     all participants, thereby potentially increasing comparability.~      Study research questions will address the following: OHCA incidence in different European~     regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting~     rhythm in patients where bystanders or EMS starts CPR or any other resuscitation~     intervention; rate of any return of spontaneous circulation (ROSC); patient status at~     handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30~     days after OHCA; incidence of patients discharged alive from hospital.~   "
62680|NCT02236806|"~     The aim of the study is to analyze the protective impact on the cardiac damage of beta~     blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based~     chemotherapy with or without trastuzumab.~   "
62681|NCT02236793|"~     The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB~     applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as~     compared to Standard of Care alone for the treatment of neuropathic and neurovascular~     diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile~     normal saline solution presented in the same multi-dose spray vials than BioChaperone~     PDGF-BB will be applied on patients of the control group).~   "
62682|NCT02236780|"~     The main purpose of the study is to assess the impact of environmental conditions on~     live-birth rates after intraconjugal IVF.~      The second purposes are~        -  to assess the impact on pregnancies (prematurity, preeclampsia);~        -  to assess the impact on newborn's health (stunted growth);~        -  to evaluate the consistency of results observed between assisted pregnancies and~          spontaneous pregnancies.~   "
62683|NCT02236767|"~     This is multiple baseline study including up to three participants with a primary diagnosis~     of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic~     stimulation study intervention.~   "
62684|NCT02236754|"~     Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to~     loss of insulin producing cells (beta cells). The amount of insulin that can be produced is~     imperfectly correlated with beta cell mass (BCM). The development of a reliable method to~     noninvasively quantify the total amount of insulin producing beta cells would be of great~     benefit by providing an important endpoint for the development of new treatments of~     diabetes. The investigators have previously identified a specific marker on islet cells~     called vesicular monoamine transporter 2 (VMAT2) that the investigators now propose to use~     in positron emission tomography (PET) scanning to determine islet beta cell mass. The PET~     radiopharmaceutical 18F-fluoropropyl(FP)-dihydrotetrabenazine(DTBZ) has been used previously~     in human subjects without adverse effects. It has shown promise in differentiating type 1~     diabetes and non-diabetes. The investigators now hypothesize that repeat PET scans will be~     reproducible in the same subject. Subjects with normal BCM will be recruited from among~     normal weight non-diabetic people with plasma insulin levels within the normal range.~     Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have~     low or non-measurable insulin levels. Two PET scan measurements will be taken in each~     subject and the amount of VMAT2 in the pancreas will be and compared for reproducible~     findings. Biochemical testing will also be performed and compared to PET scans as a~     potential indirect marker of beta cell mass.~   "
62685|NCT02236741|"~     Study to assess the risk of incident heart failure associated with the use of pramipexole~     compared with other dopamine agonists and additionally, to assess the risk of incident heart~     failure associated with the use of dopamine agonists in comparison with no use of dopamine~     agonist therapy~   "
62686|NCT02236728|"~     The primary objective of this study was to describe neurologists' population of patients~     treated with pramipexole and suffering from Parkinson's disease (so called 'primary care'~     population).~      The secondary objectives were:~        -  Evaluate the mean dose of pramipexole prescribed under actual conditions of use~          depending on the severity of the disease.~        -  Evaluate the reasons for choosing pramipexole as treatment.~        -  Identify the patient profiles determining the choice of dose of pramipexole prescribed~   "
62687|NCT02236715|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose~     vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of~     daily practice~   "
62689|NCT02236689|"~     Tennis elbow is a common occurrence in the general population that causes lateral elbow pain~     and diminished grip strength, which may be debilitating. Most affected individuals achieve~     symptom resolution within 6 months to 1 year with measures such as physiotherapy,~     anti-inflammatories and corticosteroid injections, but a small subset will go on to develop~     chronic symptoms. Chronic tennis elbow can be treated surgically, with arthroscopy gaining~     popularity in recent years as it presents a less invasive option, allows for direct~     visualization of the elbow joint for other pathology and has a faster return-to-work time~     compared to other surgical procedures. Despite its promise there have been no high quality~     studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual~     efficacy of this procedure into question. We propose a randomized, double-blind controlled~     trial comparing arthroscopic release with arthroscopic debridement for the management of~     chronic tennis elbow in an effort to definitively answer this question and provide better~     recommendations for the use of this procedure.~   "
62690|NCT02236676|"~     The purpose of this research study is to better understand how a daytime nap after training~     on a motor skill after brain injury improves performance compared with the same amount of~     time after training spent awake and resting.~   "
62691|NCT02236663|"~     Intimate partner violence (IPV), including violence in dating relationships (dating~     violence, DV) is a widespread and serious public health problem. Among U.S. female IPV~     survivors, 47.1% report their first abusive relationship occurred at college age (age~     18-24). Similarly, in national surveys, adults respondents 18-24 years of age report the~     highest rate of stalking victimization, most commonly by a former intimate partner. Safety~     planning is the most widely used intervention to prevent and respond to IPV, yet the vast~     majority of abused women never access safety planning services. Our challenge is to increase~     college women's access to safety planning, with the opportunity to consider their unique~     safety priorities and level of danger during and when ending an abusive relationship. In~     addition, while bystander interventions that train peers to safely intervene have been~     shown to be effective in sexual assault prevention on campus, and college women in abusive~     relationships most frequently disclose IPV to a friend, no similar interventions have been~     tested with friends for IPV response on campuses. Therefore, the objective of the study is~     to evaluate the:~        1. effectiveness of an interactive, personalized smart phone and web based safety~          application (App) intervention in Maryland and Oregon with: 1) college women (age~          18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The~          safety decision App allows the user to enter information on: a) relationship health; b)~          safety priorities; and c) severity of violence/danger in relationship. The App then~          uses the information to provide the user with a personalized safety planning~          information and resources; and~        2. dissemination of the App in an expanded four states (Arizona, Maryland, Missouri, and~          Oregon) to determine the reach, adoption, implementation and maintenance of App use~          among university/college students.~   "
62692|NCT02236650|"~     The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones~     Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve~     the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years),~     increase parental resilience and decrease parental stress.~   "
62693|NCT02236637|"~     The purpose of this registry is to document the characteristics and management of patients~     with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice,~     independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments,~     there is a need for a current and improved understanding of how these treatments fit into~     the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their~     relative effectiveness profiles emerge outside of a clinical trial setting. This will be~     based on documentation and description of sequencing of treatment initiation, termination,~     and duration; relative effectiveness of treatments; defined medical resource utilization~     (MRU) and quality-of-life parameters and follow-up for survival.~   "
62694|NCT02236624|"~     The purpose of the present study is to test the hypothesis that aerobic training can reduce~     flu-like symptoms following interferon beta 1a injections in patients with Multiple~     Sclerosis.~      A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a~     mechanism that can explain a potential positive effect.~   "
62695|NCT02236611|"~     This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed~     to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily~     [QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD)~     administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At~     the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive~     umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via~     BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at~     Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after~     Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and~     Day 85 (Visit 7). The total duration of subject participation in the study will be~     approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1~     (forced expiratory volume in one second) on treatment Day 85. All subjects will have~     spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and~     24 hours after the previous day's dose of open-label study medication at Visits 3 to 7.~      BREEZHALER is a registered trademark of Novartis AG.~   "
62696|NCT02236598|"~     African Americans suffer a disproportionately high risk of diabetes compared to other~     Americans. Reasons for race disparities in diabetes incidence are not completely understood.~     Although a difference in prevalence of obesity does explain a significant portion of the~     racial disparity in diabetes risk, it does not explain all of this disparity. Strategies to~     control the diabetes epidemic and reduce its racial disparity often overlook preventive~     measures. Currently, the most powerful known strategy for preventing diabetes is weight loss~     in the overweight/obese. However, because weight loss is often difficult to achieve and~     maintain, other opportunities to prevent diabetes should be identified, particularly in~     African Americans. Among potential novel opportunities is correction of low or low-normal~     potassium levels (hypokalemia). In secondary analyses, we have found low-normal potassium~     (K) to be a novel risk factor for diabetes; and we have found that this association between~     low-K and diabetes risk may be stronger in African Americans compared to whites. Therefore,~     a previously unrecognized alternative or adjunct strategy for preventing diabetes,~     particularly in African Americans, may involve correction of low or low-normal K levels~     (hypokalemia). Large-scale, adequately-powered, randomized controlled trials are needed to~     establish the effectiveness of this approach. However, prior to those trials, the~     pathophysiology of the association between low K and poor glucose metabolism must be~     understood. This pilot clinical trial will begin to determine the effect of K~     supplementation on measures of glucose metabolism in African Americans.~      In this pilot clinical trial, 30 African Americans with prediabetes and a low-normal serum K~     (<4.0 mEq/L) will be randomized to K-supplements, 20mEq (2-10mEq tablets) twice daily or a~     matching placebo capsules twice daily. Prior to randomization, baseline measures will be~     taken including measures of glucose metabolism with a 3-hour oral glucose tolerance test~     (OGTT), baseline chemistries and a baseline 24-hour urinary potassium measurement. Patients~     will take the intervention daily and will undergo repeat testing of all of these measures at~     the end of a 3 month period. The primary endpoint will be change in glucose tolerance, as~     measured by change in glucose area-under-the-curve (AUC) of a 3-hour oral glucose tolerance~     test (OGTT). Secondary endpoints will include changes in fasting, 1-hour, and 2-hour~     post-challenge glucose levels, as well as measurements of insulin secretion and insulin~     sensitivity as measures by the oral glucose minimal model method.(1) The baseline data from~     this trial will allow us to quantify abnormalities in glucose metabolism in African~     Americans with prediabetes/early diabetes and low-normal serum K. The post-intervention data~     will provide estimates of the impact of K-supplements compared to no supplements on these~     abnormalities. Data derived from the pilot study will be used in the design of a larger~     scale, adequately powered clinical trial. This trial will also help to assess the~     feasibility of recruiting this target population.~      With this pilot trial, we will begin to determine whether or not K-supplements, an~     inexpensive, well-tolerated, and simple intervention, could help to reduce diabetes risk~     among African Americans.~      ON 1/31/2016 we stopped consenting/enrolling subjects. We consented a total of 61 subjects~     of which 29 screened in and 32 screened out.~   "
62697|NCT02236585|"~     Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata~     through induction of infarction and subsequent hyaline degeneration. This could be followed~     with variable severity of pain that lasts for several days after the procedure secondary to~     the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been~     described as moderate to severe cramping increasing over the first 2 hours after UAE to~     reach plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The~     severity of pain after UAE seems unrelated to the uterine or fibroid size which makes the~     severity of pain is unpredictable.1~      Pain management after UAE most often consists of a combination of a non-steroidal~     anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following~     embolization of the uterine arteries may require large doses of parenteral opioids for~     relief with added unwanted effects.2~      Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA)~     after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during~     the first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce~     morphine consumption for the first 24 hours after UAE. 2~      Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic~     choice for uterine artery embolization as it improves patients satisfaction and reduces the~     severity of post-procedural pain.~      Although some investigators suggest an epidural analgesia for pain control after UAE,4 the~     use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain~     management after UAE.5~      Thus in an observational study included few patients, the investigators demonstrated~     considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of~     patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the~     catheterization of thoracic epidural space in such low-risk patients has many logistic~     issues.~      Up to the best of our knowledge, there is no available comparative randomized clinical trial~     compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.~   "
62731|NCT02236143|"~     The primary objective of this study is to develop new ways to acquire MRI data and/or new~     ways to analyze the acquired data.~   "
62699|NCT02236559|"~     The overall objective of this study is to determine if Vapotherm high flow nasal cannula~     therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to~     the current standard of care for non-invasive ventilatory support, non-invasive positive~     pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that~     HFT has possible advantages over NIPPV, such as decreased time to patient stability from~     respiratory failure, and the ease of use as a first line intervention for respiratory~     failure in the ED environment.~      The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical~     non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact~     on ventilation indices and a lower intolerance rate, and have a positive association with~     hospital disposition and length of stay.~   "
62700|NCT02236546|"~     This clinical trial studies how well FDG-PET/CT measures early response in patients with~     stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography~     (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose~     (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before,~     during, and after treatment may improve methods for predicting which patients may benefit~     from therapy.~   "
62701|NCT02236533|"~     The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects~     of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus~     coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized~     controlled trial.~   "
62702|NCT02236520|"~     Cardiovascular disease is the first common cause of death worldwide. Hypertension is the~     number one driving risk factor. Hypertension has long been associated with dietary salt~     intake. We believe that the accumulation of salt in the interstitium and inside cells~     represents a neglected risk factor, which initiates a pro-inflammatory state, chronically~     increases blood pressure, and leads to systemic energy imbalance. We will explore the~     concept that Na+ storage in the skin and in muscle is associated with increased blood~     pressure, a pro-inflammatory state, and reduced insulin sensitivity. We will do so by~     addressing the following specific aims:~        -  Specific Aim 1: To test the hypothesis that African Americans are characterized by~          increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced~          forearm blood flow, and enhanced pulse wave velocity~        -  Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces~          tissue Na+ content~        -  Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation~        -  Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle~          is associated with decreased insulin sensitivity and propensity to diabetes mellitus~   "
62703|NCT02236507|"~     Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry~     equipment and has been recently introduced into clinical practice. It is the most precise~     method to assess the anal sphincter pressure function and may be crucial for planning and~     controlling surgical procedures of the anorectal area. Normal values in pediatric population~     have not been established.~      The aim of this study is complex evaluation of anorectal function in children without~     symptoms from lower GI tract and establishment of normal values.~   "
62704|NCT02236494|"~     This is a randomized trial to assess the value of an emergency department-based intervention~     to reduce hazardous alcohol use among older adults. We hypothesize that the intervention~     will result in a 25% reduction in the prevalence of hazardous alcohol use while the control~     group will only have a 5% reduction.~   "
62705|NCT02236481|"~     The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret~     (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of~     anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid~     Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P.~     Cipriani (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of~     L'Aquila, L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A.,~     joint erosion and cartilage destruction.(1) Anakinra (a recombinant form of the naturally~     occurring IL-1 receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and~     IL-1β) has shown in a number of RCTs (2-6) to be effective in the treatment of R.A., in~     monotherapy,(2,4) as well as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an~     important role in the pathogenesis of T2D: Glucose has been shown to induce IL-1β~     hypersecretion through inflammasome activation, while IL-1β induces impairment of β-cell~     secretory function and β-cell apoptosis.(7) In prediabetic subjects, the expression of~     IL-1Ra is induced by IL-1β and reflects the body's response to counterbalance increased~     IL-1β activity.(7) Levels of IL-1Ra tend to rise up to 6 years before the diagnosis of~     T2D.(8,9) IL-1Ra has been successfully used as a marker for the risk of developing T2D in~     subjects with metabolic syndrome.(10) As a clinical proof of concept, IL-1 inhibition with~     anakinra in patients with T2D has shown to improve the secretorial function of beta-cells as~     well as to lower the ratio of proinsulin/insulin and glycated hemoglobin/hemoglobin~     significantly, favoring glycemic control and possibly reducing the severity and prevalence~     of the associated complications of this disease.(11) Summarizing, IL-1 inhibition with~     anakinra has a clinical impact on R.A. as well as T2D. As from 6-10% of Italian R.A.~     patients have also T2D, this trial aims at investigating the impact of IL-1 inhibition on~     both diseases. Very recent data also show that T2D is a predictor of response to~     anakinra-treatment in R.A. patients,(12) which furthermore justifies the use of anakinra in~     this subset of R.A. patients. Objectives: [Primary] To evaluate the change in HbA1c between~     baseline, 3 months, 6 months, 1 year and at last follow up of 2 years from the beginning;~     [Secondary] To evaluate the efficacy on controlling signs & symptoms of R.A., assessing the~     remission rate at 3 months, 6 months, 1 year and at follow up (2 years), using the~     evaluation scale of disease activity on 28 joints, DAS28 and SDAI improvements from baseline~     conditions over time points, according to EULAR response criteria. Methods: 200 patients in~     28 Italian centers with active R.A. refractory to treatment with methotrexate and T2D will~     be enrolled and randomized to receive either 100mg of anakinra once daily by subcutaneous~     injection or any anti-TNF-alfa drug treatment. [84 subjects will be required in each~     treatment arm to reach 90% power with an alpha error of 0.05 to detect a mean difference~     between the study arms of 0.25 percentage points of HbA1c . The assumed difference of HbA1c~     is rather conservative when compared to previously published changes in T2D patients (11).]~     Anti-diabetic treatment is required to be unchanged for at least one month prior to~     enrolment. Patients will be invited to maintain dietary habits and lifestyle during the~     study period. Further details can be viewed on the trials website after subscription.(13)~     References: (1) Arend & Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan, Arthritis Rheum.~     1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4) Nuki, Arthritis.~     Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen, Rheumatology~     2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder, Diabetes~     Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola, J.~     Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12)~     Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/~     Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to~     the Italian law decree 17 December 2004. (B) speaker fees~   "
62706|NCT02236468|"~     The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food~     Production Program implemented by HKI on household food security and nutritional status, as~     well as the impact on including additional interventions (BCC on WASH and malaria~     prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children~     aged 6-24 months old, in addition to the standard E-HFP model.~   "
62707|NCT02236455|"~     The purpose of this study is to determine the effects of complementary therapies delivered~     via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and~     self-efficacy in healing reports before, following, and at 10-day follow-up.~   "
62708|NCT02236442|"~     The purpose of this study is to determine if the use of a therapeutic and global protocol to~     relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.~   "
62709|NCT02236429|"~     Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a~     vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is~     a high rate of recurrence. Almost half of women successfully treated suffer a recurrence~     within three months. Complications include risk factors for premature birth, increased~     transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The~     investigators proposed study is a cost effective treatment based on returning the normal~     microbial balance to the vagina. The investigators propose to transfer normal vaginal flora~     from healthy individuals to women with BV and thus restore normal vaginal flora and cure~     this disorder.~   "
62710|NCT02236416|"~     The principal aim of this study is to verify whether a program of supervised, multimodal~     physical exercise improves cognitive function and/or reduces the rate of cognitive decline~     in older adults~   "
62711|NCT02236403|"~     Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and~     Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin~     inflammation, so a intervention that reduces the number of mites and bacteria would be~     desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and~     lice in humans and in animals and a single application have show a good response in lice~     eradication.~      In this study , investigators will determinate the security and effectiveness of this~     compound in the eradication of mites~   "
62752|NCT02235870|"~     This pivotal trial of the Obalon Balloon System is intended to generate safety and~     effectiveness data required to support a future marketing application. The trial has been~     designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition~     and lifestyle behavior modification program.~      Weight loss will be evaluated after the 6-month course to determine if a specific predefined~     superiority margin can be achieved in the device group compared to a sham-control group.~   "
70966|NCT02128464|"~     Customized cutting block and conventional cutting guide are both effective in improving~     accuracy and function of OA knee patients.~   "
62712|NCT02236390|"~     The purpose of the proposed pilot study is to extend previous findings regarding the~     efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by~     integrating this treatment with evidence-based treatment for posttraumatic stress disorder~     (PTSD). Cognitive processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established~     and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran~     populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith,~     Weaver, Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT~     among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified~     protocol without the utilization of written exposure (CPT-C) may be more effective than the~     original protocol. However, despite such promising evidence, individuals who experience~     chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares~     following PTSD treatment (Nappi, Drummond, & Hall, 2012). Given that nightmares are~     considered the hallmark of PTSD (Ross, Ball, Sullivan, & Caroff, 1989) and their~     treatment-resistant nature (Davis & Wright, 2007), specific psychological treatments have~     been developed to target sleep disturbances and nightmares.~      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. Though~     further evidence is needed, ERRT has exhibited strong support in reducing the frequency and~     intensity of nightmares, as well as improving overall sleep quality in both civilian and~     veteran samples. In addition, significant decreases in PTSD and depression symptoms have~     been reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al.,~     2011; Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B~     suggested treatment (Cranston, Davis, Rhudy, & Favorite, 2011).~      There is a call to research suggesting the importance of treatment studies which focus on~     interventions that integrate nightmare and sleep symptom treatment with evidence-based~     treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to~     tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect~     to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase~     CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep~     disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to~     cope adaptively (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, &~     Mayeda, 2005; Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may~     have additional personal coping resources for which s/he can use to address the broader~     trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT,~     CPT + ERRT, and CPT alone.~   "
62713|NCT02236377|"~     The purpose of this case series dismantling study is to extend previous findings regarding~     the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose~     effect and mechanism of change.~      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has~     exhibited strong support in reducing the frequency and intensity of nightmares, as well as~     improving overall sleep quality in both civilian and veteran samples. In addition,~     significant decreases in PTSD and depression symptoms have been reported following treatment~     (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, &~     Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis,~     Rhudy, & Favorite, 2011).~      Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to~     conduct a set of case series in order to examine the possible mechanisms: psycho-education,~     dose response for exposure, and no exposure components of the treatment. Each part of the~     treatment is theorized to contribute to the improved treatment outcome and it is~     hypothesized that participants will benefit no matter what group they are in. All~     participants will receive 5 treatment sessions, conducted twice per week for about 90~     minutes, of a modified version of ERRT.~   "
62714|NCT02236364|"~     Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown~     that glucose present in the fluid in the front of the eye, called the aqueous humor,~     correlates well with blood glucose. As blood glucose changes, the optical properties of the~     aqueous humor change, causing a change in the appearance of the iris of the eye.. The data~     collected in this study will be shared with IRISense to assist in validating the algorithm~     being used to develop the database needed. The data collected so far is in a narrow band of~     the normal glycemic range (healthy volunteers). We will collect standard digital~     photographic images of the eyes of subjects with diabetes along with corresponding blood~     glucose concentrations using the finger stick glucose monitoring method. In order to do this~     we will use standard digital photography techniques that is embedded in our benchtop~     prototype device~   "
62715|NCT02236351|"~     This project will assess whether there is a significant difference in compliance with~     patching in amblyopic patients whose parents are instructed to pinch the superior and~     inferior edges of the patch before applying (in order to improve comfort) versus patients~     whose parents are instructed to place the patch evenly around the orbit.~   "
62716|NCT02236338|"~     The aim of this study is to perform a randomized, prospective trial comparing the two~     current methods of treatment for chronic venous insufficiency, in an effort to evaluate~     complications and outcomes for each method, and ultimately, to see if one is superior to the~     other.~   "
62717|NCT02236325|"~     A significant percentage of individuals who die by suicide do not seek mental health~     services in the time preceding their death. This population is underserved and it is unclear~     what barriers keep them from seeking treatment. In order to begin a line of research aimed~     at addressing this high-risk population, this proposal rests on the hypothesis that suicidal~     individuals who do not seek treatment prior to attempting suicide experience the same~     psychopathological difficulties as suicidal individuals who do seek treatment - namely,~     severe emotion dysregulation. However, these non-treatment-seeker s will likely require more~     creative recruitment strategies and briefer interventions than treatment-seeking~     individuals. As such, this application proposes to use wide-reaching recruitment efforts~     throughout the community to locate and enroll individuals who are suicidal but not seeking~     treatment. Further, there is a paucity of empirical support for interventions targeting~     suicidal individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that~     have been demonstrated to be effective with a suicidal population and is the only treatment~     whose effectiveness has been replicated. Previous research has suggested that an abbreviated~     version of the skills that are taught in DBT skills training have effectively reduced~     emotion dysregulation (i.e., depression and anxiety) in problem drinkers and the format of~     the proposed intervention is derived from this evidence-based emotion dysregulation~     intervention. As such, the proposed research is a randomized, controlled pilot trial of a~     very brief, one-time, skills-based intervention targeting difficulties in emotion regulation~     and distress tolerance.~      This research aims to evaluate the safety of the intervention, the feasibility of the~     research methods (including the appropriateness of the relaxation training control~     condition), and to preliminarily estimate the immediate (one week) and long-term (one and~     three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to~     a relaxation training control on the primary outcomes of suicide ideation and emotion~     dysregulation as well as a number of secondary outcomes. These results will inform the~     design of a subsequent full-scale randomized controlled trial of the DBT-BSI.~   "
62718|NCT02236312|"~     The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a~     single treatment of three different doses of botulinum toxin compared to placebo, in the~     treatment of moderate to very severe glabellar frown lines.~   "
62763|NCT02235727|"~     A Single Dose Study of GBR 900 in Healthy Volunteers.~   "
62764|NCT02235714|"~     The purpose of this study is to obtain markers of airway inflammation from the exhaled~     breath condensate (the moisture in exhaled air) for comparison to blood based markers. These~     markers will be compared in tetraplegic, asthmatic and able-bodied control groups.~     Additionally, lung function testing will be performed, and the associations between breath~     condensate and blood markers and pulmonary function explored between groups.~   "
62719|NCT02236299|"~     The heart requires nutrients and oxygen carried in the blood to generate energy for healthy~     pump function. Blood is supplied via heart vessels called coronary arteries. When the~     arteries narrow the investigators call this coronary artery disease. Narrowing and blockage~     of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction~     in pump function) and if prolonged even irreversible muscle damage known as a heart attack.~     The investigators can treat patients with coronary artery disease with drugs that reduce the~     workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed~     coronary arteries and improve the blood supply. These treatments can relieve angina, improve~     breathlessness and avert heart muscle damage during a heart attack. A potential new~     mechanistic effect is emerging by modulating the type of fuel used by the heart to generate~     energy more efficiently has been tested in the left ventricle. This study is designed to see~     if mechanistic effect provides the same protection in the right ventricle. It is hoped that~     this may further improve heart pump function and reduce the size of a heart attack in~     patients with coronary artery disease.~   "
62720|NCT02236286|"~     This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's~     disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,~     resting state, functional brain connectivity (Aim II), and determine the number of subjects~     needed for a future, randomized clinical trial to test the efficacy of our novel, Agility~     Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches~     to these aims are cutting edge and will allow us to develop sensitive behavioral and brain~     biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.~   "
62721|NCT02236273|"~     Emerging communication technologies, such as text messaging offer low-cost, scalable~     opportunities to improve health literacy and promote healthy behaviors, such as vaccination.~     While the investigators reported the success of text message vaccine reminders, effects were~     limited by their untailored approach. The trans-theoretical model of behavior change~     supports tailoring interventions to an individual's stage of decision-making. Human~     papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can~     lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is~     90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV~     vaccine completion rates. Limited health literacy regarding the vaccine can affect series~     completion. The investigators will compare the effects of enhancing text message vaccination~     reminders with interactive, vaccine health literacy-promoting information tailored to~     vaccine decision making-stage on HPV vaccine series completion. The effects of these~     messages represent a new paradigm in interactive health communications.~   "
62722|NCT02236260|"~     The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely~     demonstrated. The success of this procedure requires that the patient is awake and~     cooperative. The conditions of this intervention can be difficult to tolerate by the patient~     for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly~     the head in the stereotactic frame), stress related to the localization of the DBS. It is~     therefore important to improve the comfort as well as the cooperation of the patient, during~     implantation of the DBS electrodes, in order to optimize the conditions of the intervention.~     In addition to analgesia, acupuncture should allow sedation without affecting alertness and~     should contribute to the regulation of any vegetative reactions during the procedure.~     Therefore, we hypothesize that acupuncture could improve the quality of care of the patient~     during a DBS procedure. In practice, this is electroacupuncture that will be used in this~     research to maintain the stimulation of acupuncture points to an optimal level during the~     time of the intervention.~   "
62723|NCT02236247|"~     Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate~     control in patients with decompensated heart failure (DHF).~   "
62724|NCT02236234|"~     Besides the specific response to vaccine antigens, the investigators will analyze the~     anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The~     hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess~     the range of the count with the highest possibility of vaccine response. Thus, knowledge of~     vaccine response in HIV-infected patients, indicate which patients would have greater~     potential for vaccine response in vivo.~   "
62725|NCT02236221|"~     The purpose of this study is to observe the effect of lack or excess of Vitamin D in the~     first, second and third trimester on child birth weight, fat content and the secretion of~     metabolism related hormone, and clinical follow-up their offspring obesity.~   "
62726|NCT02236208|"~     The purpose of this study is to observe the effect of lack or excess of folic acid in first,~     second and third trimester on child birth weight, fat content and the secretion of~     metabolism related hormone, and clinical follow-up their offspring obesity.~   "
62727|NCT02236195|"~     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a~     Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced~     urothelial carcinoma that has specific changes in tumor genes. Patients must have previously~     received treatment with chemotherapy that included a platinum-containing agent such as~     cisplatin. The study will enroll in stages, with 15 patients in the first stage. More~     patients will be added to the study if enough patients having beneficial responses are~     observed. Mocetinostat will be administered using oral capsules three times each week (eg,~     Monday, Wednesday and Friday). The study is designed to evaluate whether the number of~     patients responding to treatment is substantially higher than would be expected with other~     available treatments.~   "
62728|NCT02236182|"~     Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium~     bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG~     monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium~     bromide as delivered by the RESPIMAT® device when administered over a two-week period.~   "
62729|NCT02236169|"~     The objective of this study was to determine the pharmacokinetic comparability of 84 µg~     ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol~     in COPD patients~   "
62730|NCT02236156|"~     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on~     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in~     women with a history of recurrent BV.~   "
62732|NCT02236130|"~     Context:~      Single shot peripheral nerve blocks have limited duration of action depending on the local~     anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need~     oral analgesics at home once the block wears off to control the pain.~      Objectives:~      Primary Objective~      To determine if peripheral nerve blocks have any advantage in terms of decreasing oral~     analgesic requirements in the post operative period even after the effects of the block have~     worn off~      Secondary Objective~      To determine if inclusion of single shot regional technique improves patient/family~     satisfaction with post operative pain management .~      Study Design:~      Prospective randomized single blinded study.~      Inclusion Criteria~        -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic~          surgery with moderate to severe postoperative pain.~        -  Surgery of moderate duration (<2hr)~        -  Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)~        -  American Society of Anesthesiologists (ASA) classification 1 or 2~        -  Parents able to understand follow up instructions and are able to reach at home by~          phone~      Exclusion Criteria~        -  Known allergy to local anesthetics~        -  Preexisting neuropathy with sensory or motor deficits~        -  Skin infection at site of needle placement~        -  Parents refusal for peripheral nerve blocks~   "
62733|NCT02236117|"~     The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,~     many studies have been disseminated of heart rate variability in adults, however few results~     in a literature this parameters in pediatric population, mainly with children submitted the~     physical training. Thus, this Project aims to verify the effects of aerobic training, with~     10 weeks, in prepubertal on the performance and heart rate variability in rest.~   "
62734|NCT02236104|"~     A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve~     airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to~     confirm the beneficial effects of this treatment in a larger neuromuscular population, to~     study its mechanisms of action and to assess whether the effects observed persist over time.~     A better knowledge of this treatment should help to define its position in the respiratory~     management of neuromuscular patients.~   "
62735|NCT02236091|"~     The overall aim of this project is to monitor everyday life activity of children with~     neurological disorders undergoing rehabilitation using wearable sensors capable of accurate~     and unobtrusive long-term measurement.~      Specific objectives:~        1. To adapt the sensors for the use by children with neurological disorders. The focus~          lies on the exact positioning and the investigation of the needed amount of IMUs.~        2. To validate the sensor data with collected video recordings and to develop specific~          algorithms to automatically extract specific movements and to analyze long-term sensor~          recordings.~        3. To perform a cross-sectional study to assess intensity, task-specificity and duration~          of upper and lower limb activity during rehabilitation. There, we aim to gain objective~          information about levels and types of activity during rehabilitation in relation to~          age, gender and disorder.~        4. To conduct a responsiveness study to assess whether or not the sensor output is able to~          highlight changes over time during rehabilitation.~      Therefore, at time point T=0 (shortly after admission to our center), participants are~     equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum).~     Additionally, a small wearable camera is mounted to the chest. The participants then return~     to their everyday life for 4 hours (no therapies, measurement period is in the evening).~     Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol~     is being repeated 4 weeks later (time point T=1).~   "
62736|NCT02236078|"~     Multidrug-resistant (MDR) tuberculosis (TB) must be treated with second-line drugs (SLD)~     that are less effective, more toxic, and more expensive. Treatment requires at least 20~     months with 4 or more effective drugs based on timely drug susceptibility test (DST)~     results. However, there are many examples of closely related drugs with differing~     antimicrobial activities.~      Labs have found differences in DST results among the rifamycins, rifampin (RMP) and~     rifabutin (RBT); the fluoroquinolones, ofloxacin and moxifloxacin; and the second-line~     injectable agents, kanamycin, amikacin, and capreomycin. In a related finding, isolates~     resistant to 0.2 mcg/ml INH may be susceptible to higher concentrations. In the Preserving~     Effective Tuberculosis Treatment Study (PETTS), 32% of RMP-resistant isolates were~     susceptible to RBT, 41% of kanamycin-resistant isolates were susceptible to capreomycin, and~     45% of isolates resistant to 0.2 mcg/ml INH were susceptible to 1.0 or 5.0 mcg/ml (1). Other~     studies have demonstrated differences in DST results between moxifloxacin and ofloxacin.~     Whether these in vitro results translate into clinical efficacy is completely unknown. Given~     the severely limited treatment options in MDR TB, it would be exceedingly useful to know~     whether these in vitro results translate into evidence for clinically meaningful treatment~     decisions.~      The investigators will determine the clinical bactericidal activity of certain antibiotics~     against M. tb that appear to be effective in vitro even though closely related drugs from~     the same class are ineffective in vitro. Further, the investigators propose to determine the~     molecular genetic determinants of these differences.~      Specifically, we plan to determine:~        1. The bactericidal activity of RBT in patients whose baseline DST results demonstrate~          susceptibility to RBT and resistance to RMP.~        2. The bactericidal activity of high-dose INH in patients whose baseline DST results~          demonstrate susceptibility to high concentrations of INH and resistance to low~          concentrations of INH.~        3. The bactericidal activity of RMP when an approved molecular assay demonstrates genetic~          mutations associated with RMP resistance, but the phenotypic testing demonstrates~          susceptibility to RMP.~        4. The bactericidal activity of moxifloxacin in patients whose baseline DST results~          demonstrate susceptibility to moxifloxacin and resistance to ofloxacin.~        5. The bactericidal activity of amikacin and capreomycin in patients whose baseline DST~          results demonstrate susceptibility to either of these two drugs and resistance to~          kanamycin.~        6. The genetic mutations associated with both in vivo and in vitro drug resistance and~          bactericidal activity.~      To achieve these objectives the investigators propose an innovative variation on early~     bactericidal activity (EBA) study methodology. Patients at risk for MDR TB will be screened~     for RMP resistance and INH resistance using molecular assays. In those with RMP-resistant or~     INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct~     method in the Bactec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will~     be available within 14-21 days. If the DST results show, for example, RMP resistance but~     susceptibility to RBT, consenting patients will be treated with RBT by itself for 10 days.~     The investigators will assess its effect with serial quantitative sputum cultures. If the~     concentration of viable bacteria decreases significantly, the investigators will interpret~     this to mean the drug is having an effect. If not, the drug is ineffective. After 10 days,~     the patients will resume individualized multidrug treatment based on the full set of DST~     results.~      In case the investigators identify drugs that are effective under these conditions, the~     investigators will sequence known and putative genes associated with the action of these~     drugs for the mycobacterial isolates from these patients.~      The results would have immediate implications for treatment of MDR TB and for diagnostic~     mycobacteriology.~   "
62737|NCT02236065|"~     This open label trial is conducted to investigate the efficacy and safety of the combination~     therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor~     (G-CSF) for patients with brain injury or neurodegenerative disorders.~   "
62738|NCT02236052|"~     This is a multiple sites phase II trial, randomized, observer-blind, dose ranging,~     placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a~     single intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine~     administered in elderly subjects (50 years old and more).~      A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75~     subjects to receive one injection of either a non-adjuvanted low, medium or high dose level~     of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined~     with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate~     buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80)~   "
62739|NCT02236039|"~     The investigators are investigating the effects of traffic-related diesel exhaust on lung~     function and the immune system in those at risk for COPD. The individual will be exposed to~     either filtered air (FA) or carefully controlled levels of diesel exhaust (DE) in our~     exposure chamber. Post exposure the individual will complete a steady state exercise test.~     24h later, a procedure called bronchoscopy (whereby a thin, flexible tube is placed down the~     throat and into the lungs) will be used so that samples can be collected from the lungs.~     After 1 month the entire procedure will be repeated with the alternative exposure.~   "
62740|NCT02236026|"~     The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an~     bolus injection on the corrected QT interval using Fridericia's formula (QTcF).~   "
62741|NCT02236013|"~     The purpose of this study is to describe the dose limiting toxicities (DLT) and define the~     maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin remission~     induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This~     study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination~     with cytarabine/idarubicin remission induction and high-dose cytarabine (HiDAC)~     consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the~     effect of ASP2215 on the PK of cytarabine.~   "
62765|NCT02235701|"~     This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with~     ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.~   "
62766|NCT02235688|"~     This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus~     gemcitabine in Subjects with solid tumors.~   "
62767|NCT02235675|"~     Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating~     tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from~     1.5mm to 4.5mm.~   "
62742|NCT02236000|"~     This study is being done for the following reasons:~        -  The study has two parts. The purpose of the first part (Phase I) of the study is to~          find out the highest dose of neratinib that can be given safely with T-DM1.~        -  The purpose of the second part of the study (Phase II) is to find out whether the dose~          of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting~          worse for a period of time.~        -  In order to learn more about study therapy levels in blood and discover genetic and~          protein changes associated with cancer, the study includes special research tests using~          samples from blood and from breast tumor. Blood samples will be collected before study~          treatment, once during treatment, and after study treatment stops.~        -  In the optional part of this study, three biopsies will be performed to obtain fresh~          tumor samples from an area where your cancer has spread.~   "
62743|NCT02235987|"~     The study is designed to investigate the safety, tolerability and efficacy of DG3173 in~     untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and~     one dose of octreotide, the current gold standard of medical therapy for acromegaly, with~     each patient receiving all doses of DG3173 as well as octreotide.~   "
62744|NCT02235974|"~     To perform an exploratory single center randomized study that will form the basis for a~     larger scale, more definitive randomized clinical trial to determine the optimal time after~     stroke for intensive motor training. The investigators will perform a prospective~     exploratory study of upper extremity (UE) motor training delivered at higher than usual~     intensity at three different time points after stroke:~        -  early (initiated within 30 days)~        -  subacute/outpatient (initiated within 2-3 months)~        -  chronic (initiated within 6-9 months)~      The control group will not receive the therapy intervention during the 1-year study.~      Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and~     one year after stroke onset.~      Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or~     chronic (6-9 months after stroke onset) time points, participants randomized to early~     intensive motor training will show greater upper extremity motor improvement measured at one~     year post stroke.~   "
62745|NCT02235961|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the~     body) for single doses of NNC9204-0530 alone and in combination with liraglutide in~     overweight to obese but otherwise healthy male subjects.~   "
62746|NCT02235948|"~     The purpose of this study is to determine whether folic acid supplementation are effective~     on arsenic lowering in a chronic, low-level arsenic exposed population.~   "
62747|NCT02235935|"~     Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non~     proliferative DR and proliferative DR. The damage is caused by either macular edema, macular~     ischemia that can be followed by vascular proliferation.~      Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in~     the tissues and has been proven to be beneficial in treating different wounds in diabetic~     patients but its effect hasn't been tested in diabetic retinopathy yet.~      This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due~     to different indications such as chronic wounds or radiation damages and who also have~     diabetic retinopathy. These patients will undergo opthalmic physical examination including~     fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography).~     Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe~     Medical Center for all diabetic patients prior to their first treatment.~   "
62748|NCT02235922|"~     The purpose of this study is to analyze the effects of a dual task protocol on cognitive~     domains and functional capacity in non-sedentary older adults.~      The hypothesis of the present study is that older people undergoing to a dual task exercise~     protocol have greater benefits on cognition and functional performance, compared to a~     standard exercise protocol.~   "
62749|NCT02235909|"~     The purpose of the study is to evaluate the efficacy and safety of the study drug relative~     to an active comparator losartan which the same class of drug and is approved for use in the~     pediatric population aged 6 years and older. Approximately 260 subjects will participate in~     a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,~     randomized placebo-controlled withdrawal phase. This study also includes a 44-week,~     open-label extension (OL Phase) in which all subjects will receive AZM and other~     antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood~     pressure will be assessed in the clinic throughout the study, and subjects may also~     participate in a 24-hour ambulatory blood pressure monitoring (ABPM) procedure at baseline,~     at the end of the DB Phase and at the end of the OL Phase.~   "
62750|NCT02235896|"~     The ultimate goal of our partnership with local African-American churches is to implement an~     effective, multi-component intervention to increase awareness of the critical importance of~     healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the~     American Heart Association (AHA) prevention strategy, &quot;Life's Simple 7&quot; to address~     the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes,~     cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy~     consists of a community-based participatory research approach that involves focus groups to~     assess participant knowledge and beliefs about CVD risk factors prior to program initiation.~     We will also determine participant dietary and exercise practices, knowledge and perceptions~     related to healthy lifestyle and chronic diseases, demographic/health status information,~     health care utilization, biometrics (weight, blood pressure, blood tests for glucose and~     cholesterol, etc.) and attitudes about medical research at baseline, program completion and~     6-month follow-up.~   "
62751|NCT02235883|"~     The objective of the HEART Study is to develop a multiscale model of the coronary~     circulation based on multimodal imaging data (angiography, echocardiography). The predictive~     comprehensive multi-scale model, developed during this proof-of-concept study, will be used~     for analyzing functional aspects of coronary artery disease. Model validation is performed~     against invasive measurements~   "
62768|NCT02235662|"~     The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR),~     TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate~     pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate~     acceptability of the IVRs.~   "
62753|NCT02235857|"~     Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant~     lipoproteins including low density lipoprotein from circulating blood flow and rapidly~     reduces the plasma cholesterol level. The system was originally developed for the treatment~     of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied~     to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring~     about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g,~     proteinuria and hypoproteinemia).~      Although the definitive mechanism by which the system may relieve nephrotic syndrome is~     unknown, it has been recognized as one of alternative therapies for refractory nephrotic~     syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the~     Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of~     Nephrology.~      This study is conducted as a post approval study imposed by Humanitarian Device Exemption~     (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the~     treatment of drug-resistant pediatric primary FSGS.~   "
62754|NCT02235844|"~     This research study is designed to evaluate the effects of human umbilical cord mesenchymal~     stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle~     regenerative and anti-inflammatory properties of UC MSCs position them as a possible~     treatment option for DMD. Both of these properties could lead to potential benefits for a~     DMD patient.~   "
62755|NCT02235831|"~     The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort~     Plus® (DACP) MF contact lens using new objective measurements.~   "
62756|NCT02235818|"~     The purpose of this study was to compare the immediate efficacy of Counterforce brace versus~     kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a~     repetitive physical task. The investigators hypothesized that there would be difference in~     the outcomes with respect to interventions and activity. Patient came for one hour long~     Single occasion testing session and were not followed up after the testing was complete.~   "
62757|NCT02235805|"~     Observational epidemiologic studies have observed an inverse relationship between daily~     dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also~     beneficially affect other cardiovascular risk markers. Whether all these effects translate~     into improved vascular function is not known. Different vascular function markers at various~     stages on the pathway between diet and disease exist. One of these markers, vascular~     stiffness, is closely related to the process of atherosclerosis, an independent~     cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To~     examine the integrated effects of interventions on cardiovascular risk, vascular stiffness~     may therefore serve as a marker at the later stage of cardiovascular disease development.~      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,~     placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium~     on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold~     standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary~     excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time~     courses of an increased magnesium intake on changes in BP, other markers reflecting vascular~     function, and plasma biomarkers related to low-grade inflammation and vascular activity will~     be measured to unravel possible cause-effect relationships.~   "
62758|NCT02235792|"~     This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as~     pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson~     disease. Newly developed technology allows for the chronic recording of these brain signals~     at the same time as clinical stimulation is occuring. We will learn both whether these HFO~     correlate with disease activity and whether the HFO change in response to ongoing~     stimulation (potentially giving insight into the underlying mechanism of action of DBS).~   "
62759|NCT02235779|"~     Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies~     done via bronchoscopy in the investigation of interstitial lung disease in comparison with~     videothoracoscopy-assisted surgical lung biopsy.~   "
62760|NCT02235766|"~     Purpose of the observational study is to assess the capability of a satellite~     tele-echocardiography (STE) system to acquire and transmit echocardiographic images and~     clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of~     quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac~     resynchronization therapy response will be evaluated.~   "
62761|NCT02235753|"~     Despite the well-known health benefits of physical exercise in the prevention of chronic~     diseases, less attention has been focused on the use of physical exercise as an essential~     part of good treatment for chronic disease. The aims of the study are to investigate the~     feasibility, medical effects, cost-effectiveness, and social perspectives of the~     individualized exercise-based rehabilitation [2 different high-intensity training (HIT)~     protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event.~     The medical aim is to study mediating mechanisms of the physiological, biochemical and~     molecular effects of exercise training on the clinical outcomes. The aim of the~     health-economic evaluation is to assess the changes in the Health-Related Quality of Life~     (HRQL) and health care related costs for estimating the cost-effectiveness of HIT-based~     exercise rehabilitation. The purpose of the sociological analysis is to find out the social~     processes which make possible the emergence of the desired welfare effects.~   "
62762|NCT02235740|"~     This open-label, 2-part Phase I/ randomized Phase II multi-center study is conducted to~     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of~     afuresertib in combination with carfilzomib versus carfilzomib alone, in subjects with~     relapsed/refractory MM. Part 1 will evaluate 2 dose levels (125 milligrams [mg] and 150 mg~     of afuresertib) in 16 subjects (approximately 8 in each parallel arm) to determine an~     optimal dose of afuresertib for administration in combination with carfilzomib in Part 2. If~     neither of these dose levels are tolerated, an additional dose level of 100mg of afursertib~     in combination with carfilzomib may be explored in approximately 8 additional subjects. Part~     2 was to investigate the safety, and clinical activity of the combination of afuresertib~     with carfilzomib (determined in Part 1) compared to carfilzomib alone, in approximately 100~     subjects (50 in each parallel arm), however the study was terminated after the~     discontinuation of the single subject following the transition of the afuresertib~     development program from GSK to Novartis. The reason for the study termination is that the~     protocol defined study treatment was no longer aligned with the evolving standard of care.~   "
62769|NCT02235649|"~     Reduced social and community functioning is a predominant and enduring feature in people~     experiencing severe mental illness such as psychosis. The large majority of interventions~     (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and~     delusions) but poorly address functional and social consequences of the illness.~      This study attempts to fill this gap by assessing the feasibility and acceptability of a~     psychological intervention targeting social cognition deficit in people with psychosis. The~     intervention is a group psychological treatment facilitated by a clinical psychologist~     targeting competencies such as emotion recognition, social situation appraisal and guessing~     people's intentions and mental states. The group therapy takes advantage of audiovisual~     material to illustrate strategies and thinking styles that may help participants to overcome~     difficulties in social settings.~      A second objective of this study is to test a new method to measure social cognition. Recent~     research showed that interview and performance based tests are poorly associated with every~     day activity of people with schizophrenia. This study is planning to evaluate the~     feasibility of new assessment methods for social cognition in everyday life using portable~     electronic devices (Experience Sampling Method and an activity watch). These devices will be~     carried by participants in their everyday life and will ask about feelings and levels of~     social activities at random times and record basic physiological and activity levels.~   "
62770|NCT02235636|"~     To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and~     conventional Laparoscopic surgical suturing among novice~   "
62771|NCT02235623|"~     This is a randomized trial designed to evaluate testicular outcomes after a single stage~     versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in~     the abdomen. Also to determine and compare the costs, surgical complications and the health~     related quality of life for the two procedures. Testicular outcomes will be measured using a~     scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for~     those randomized to a 2 stage surgery).~   "
62772|NCT02235610|"~     The overall objective of this study is to evaluate the clinical effectiveness of the novel~     technique of donor EVLP in increasing lung transplant activity by allowing previously~     unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to~     utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory~     molecules (biomarkers) that would benefit a successful pre-conditioning and increase~     knowledge of the lungs inflammatory response before transplantation.~   "
62773|NCT02235597|"~     The investigators seek to improve health systems so underserved people, patients without~     insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access~     health care for common problems and acute care needs (same day appointments).~   "
62774|NCT02235584|"~     In this study we examine whether inducing insulin resistance by dexamethasone in healthy~     volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.~   "
62775|NCT02235571|"~     The investigators developed iChoose Kidney -- a shared decision-making support tool~     accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers~     with a simple, standardized, easily accessible, statistically robust tool for use in the~     clinic to guide patient education and healthcare decision-making about treatment options of~     dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with~     estimates of their individualized 1 and 3-year risks of mortality on dialysis vs.~     transplantation, based on previous national data. The tool has the potential to improve~     communication and decision-making between patients and their healthcare providers and~     improve access to kidney transplantation among patients with ESRD.~      This will be a two-arm, randomized study, and will be conducted at 3 large transplant~     centers with diverse patient populations. One group of patients will receive standard~     education alone during their scheduled transplant evaluation. The second group will receive~     the standard education as well have the provider use the iChoose Kidney aid with them. The~     project timeline will be a total of 24 months inclusive of enrollment, follow-up, data~     analysis, and outcome evaluation.~      This study will assess how well the iChoose decision aid works in improving patient~     knowledge, preferences for treatment, and patient access to transplant. The study will also~     assess whether providers find the tool useful for providing ways to share information with~     patients about ways to treat their kidney disease.~   "
62776|NCT02235558|"~     The purpose of this study is to determine whether super-selective intra-arterial~     administration of verapamil immediately following successful intra-arterial thrombolysis is~     safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and~     intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical~     thrombectomy). Experimental procedure is superselective injection of verapamil~     intra-arterially.~   "
62777|NCT02235545|"~     The purpose of this post approval study is to characterize the chronic performance of the~     SJM Optisure family of HV leads in patients.~   "
62778|NCT02235532|"~     This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and~     gingivitis.~      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and~     10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided~     into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out~     period was allowed and then subjects used fluoride toothpaste for the next 30 days . This~     order was reversed in group 2.~   "
62779|NCT02235519|"~     The goal of this study is to build a mathematical model to explain the effect of two doses~     of azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory~     parameters (cytokines) in function of metabolic strata like obesity, type 2 diabetes~     mellitus, hypertension and their combinations.~   "
62780|NCT02235506|"~     The investigators compared continuous epidural infusion with combined continuous femoral and~     single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and~     secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation~     indices.~   "
62781|NCT02235493|"~     The purpose of this study is to characterize the natural history of HPP in patients with~     Juvenile-onset HPP who served as historical controls in ENB-006-09.~   "
62782|NCT02235480|"~     The aim of this study is to determine the efficacy and safety of topical application of the~     gel compared to placebo in nail psoriasis.~   "
62785|NCT02235441|"~     There is growing evidence of the integral role of exercise following cancer treatment.~     Randomized trials show that exercise improves post treatment symptoms and quality of life in~     breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause~     mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50%~     relative risk reduction in cancer specific death and 20-50% relative risk reduction in all~     cause mortality have been reported with exercise. At present it is unknown if preclinical~     pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before~     launching into further studies of exercise training on changes in tumor hypoxia and response~     to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures~     of exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are~     associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2.~     Whether changes in measures of exercise exposure over the course of CRT are related to~     changes in tumor hypoxia and response to CRT.~   "
62786|NCT02235428|"~     To determine whether addition of ipratropium bromide to salbutamol nebulisations produces~     significantly greater bronchodilation in young children presenting to an emergency~     department with an acute attack of asthma~   "
62787|NCT02235415|"~     Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential~     hypertension. To obtain information on the dosage used in practice and the tolerance at the~     start of treatment (12 weeks)~   "
62788|NCT02235402|"~     The aim of this study is to compare the effects of lacidipine on markers of platelet~     activation and other rheological factors in hypertensive patients with those of~     bendrofluazide~   "
62789|NCT02235389|"~     The general aim of this study was to assess the feasibility of treating acute myocardial~     infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase~     (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition~     by paramedics~   "
62790|NCT02235376|"~     Identification of criteria associated with extubation failure of brain injured patients.~     Elaboration of a prognostic score of extubation failure of brain injured patients.~   "
62791|NCT02235363|"~     In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars~     with desired results. Especially to improve the jowls and nasolabial folds, the thread lift~     is a simple and inexpensive technique for patients who do not wish to undergo the typical~     facelift surgery, but the weak points of it are less effective and shorter duration than the~     conventional facelift.The investigators propose the new method of the thread lifting the~     subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments~     with two fixation points on both temporal fascia and retaining ligaments.~   "
62792|NCT02235350|"~     Epidemiological studies report that 85% of stroke survivors show hemiparesis and a~     percentage ranging from 55% to 75% report upper limb functional impairment. Early~     rehabilitation in stroke patients with motor disorders can be effective to restore the~     affected function and to improve the performance of daily activities. Up to now, different~     methods and techniques have been used to recover motor functions in stroke patients.~     However, none of these has been conclusively proven to be more effective than the others.~     The clinical benefits induced by motor rehabilitation are closely related to~     neuroplasticity. The main aim of the present study is to assess the efficacy of action~     observation treatment, based on Mirror Neuron System (MNS), in the rehabilitation of upper~     limb motor functions in acute stroke patients. The study will also aim at assessing~     neuroplasticity within areas belonging to the MNS through functional magnetic resonance~     (fMRI).~   "
62793|NCT02235337|"~     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the~     duration of time for a student-athlete to return to participation in sports after a sports~     related concussion.~   "
62794|NCT02235324|"~     This phase II trial studies how long it takes colorectal cancer resistant to standard~     treatment to grow while receiving treatment with ziv-aflibercept, and how well adding~     fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage~     IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop~     the growth of colorectal cancer by blocking the formation of tumor blood vessels.~     Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to~     stop the growth of tumors cells by preventing the cells from growing and dividing.~     Leucovorin calcium helps fluorouracil work better. Adding fluorouracil and leucovorin~     calcium to ziv-aflibercept may be an effective treatment for patients who progress on~     ziv-aflibercept alone.~   "
62795|NCT02235311|"~     Despite recommendations from clinical practice guidelines to discharge patients from the~     hospital on once daily proton pump inhibitors after acute management of UGIB, clinical~     practice is to use twice daily proton pump inhibitor therapy. The objective of this study~     will be to assess whether or not once daily pantoprazole is non-inferior to twice daily~     pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump~     inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe~     for any potential difference in safety for once daily versus twice daily proton pump~     inhibitors.~   "
62796|NCT02235298|"~     Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective~     sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with~     type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is~     a consistent associated finding. Because dapagliflozin increases urinary glucose excretion,~     weight loss could result from reduced body fat secondary to caloric loss or from fluid loss~     secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether~     Dapaglifozin may cause a reduction in visceral fat is unknown.~      Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin~     causes a rapid and significant reduction of the epicardial fat, the visceral fat of the~     heart, in type 2 diabetic patients.~      This hypothesis would be tested in a prospective interventional study in 100 overweight or~     obese type 2 diabetes subjects.~   "
62797|NCT02235285|"~     In 162 Asian patients, primary breast augmentations were performed by a single surgeon~     during 5 years. The purpose of this study evaluates Asian outcomes in primary breast~     augmentation using single antibiotic breast irrigation by a single surgeon's practice and~     examines the comparison of Asian and Western outcomes in primary breast augmentation.~   "
62800|NCT02235246|"~     Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or~     premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal~     neoplasms, increases the rates of histologically complete resections, and also reduces local~     recurrence rates. Despite these advantages, ESD is thought to induce various complications.~     Wellknown ESD-related complications include perforation, postoperative bleeding, or~     stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is~     one of these frequently noticed minor ESD related complications, is the main reason for~     prolongation of the hospital stay, and is related to patients' compliance; however, there is~     a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD~     are thought to be associated with transmural burn or transmural air leak. Some studies have~     tried to control localized pain during and after ESD using local lidocaine, single dose~     postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been~     reported to alter the perception and duration of pain and produce important analgesic~     effects. It is included the suppression of neuropathic pain, potentiation of morphine~     analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet~     fully understood, the analgesic properties of magnesium are believed to stem from regulation~     of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the~     central nervous system. Also, magnesium may prolong neuromuscular blockade after~     administration of neuromuscular blocking drugs, increase sedation and contribute to serious~     cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively~     better operative field, reduction in the duration of surgery and reduced blood loss. There~     have been no previous trials on the use of magnesium specifically for pain control following~     ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for~     pain relief after ESD.~   "
62801|NCT02235233|"~     This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on~     the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin~     disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy~     subjects compared to patients with NASH.~   "
62802|NCT02235220|"~     In this study it is to be evaluated wether a restoration with composite resin fillings to~     reestablish a canine guidance will reduce masticatory muscle activity in patients with~     bruxism.~   "
62803|NCT02235207|"~     The purpose of the study is to investigate the effectiveness of Fustra® exercise program in~     relieving recurrent pain in the neck or/and back, and thus improve quality of life in female~     and male office workers. The hypothesis is that neuromuscular exercise will improve control~     of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and~     leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In~     addition, financial feasibility of the exercise program and effects of training on quality~     of life and perceived work ability are studied.~   "
62804|NCT02235194|"~     It has previously been shown in healthy overweight subjects, that table water including a~     defined amount of amino acids and chromium can decrease the postprandial glucose and insulin~     response. In this study, the effect of this table water on glucose excursions after a test~     meal containing a defined amount of available carbohydrates, protein and fat will be studied~     in patients with early type 2 diabetes or prediabetes according to guidelines that are~     treated with dietary measures or metformin only. The study will be conducted in a cross~     -over design, double blinded and placebo controlled including 20 participants. The primary~     endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc)~     within 180 minutes after ingestion of the meal.~   "
62805|NCT02235181|"~     This study aims to determine whether the Arabin cervical pessary prevents preterm birth in~     women with a twin pregnancy and a short cervix.~   "
62806|NCT02235168|"~     To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.~   "
62807|NCT02235155|"~     The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol~     medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.~   "
62808|NCT02235142|"~     Open study to make a comparison between hypogonadism and euogonadism patients regarding the~     severity of prostate cancer. The purpose of this study is to determine the importance of the~     relationship between the hormonal status and the type of the tumor at the time of surgical~     intervention as well as follow up of the patients.~   "
62809|NCT02235129|"~     To compare the relationship between breath-hold time and the distance in a Six Minute~     Walking Test in chronic obstructive pulmonary disease population.~   "
62810|NCT02235116|"~     This is a cross-sectional survey distributed to a convenience sample of patients in a~     waiting room of an academic dermatology clinic. The survey assesses patient experiences with~     full body skin exams and attitudes towards full body skin exams. The survey is designed to~     help investigators better understand how many patients are not getting full body skin exams,~     why this may be occurring, and what types of interventions may be enacted to increase the~     number of patients getting full body skin exams.~   "
62811|NCT02235103|"~     Recent research has revealed that subtle abnormalities can be found in sperm samples that~     seem to be normal with conventional analysis techniques. The DNA in the sperm heads is~     sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained~     infertility do not achieve pregnancy.~      We are planning a study to examine the incidence of DNA fragmentation in the sperm of~     couples with previously unexplained infertility. In a first treatment cycle with~     intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured.~     Afterwards the results of the patients who are pregnant will be compared with those of the~     not pregnant ones. We expect to find differences between both groups.~      100 patients will be included in the study.~   "
62812|NCT02235090|"~     Clinical trials organization in several neuromuscular disorders (NMD) has some specific~     issues. Nonambulant status and difficulties with transportation are among them. Moreover a~     lot of patients with NMD have so poor condition that even short transportation is able to~     worse it. Such situation forces researchers to limit a region of recruitment for clinical~     trials and to exclude from trials more severe subgroup of patients, which cause additional~     issues especially for rare diseases.~      The purpose of this study is to prove hypothesis about possibility to reliably monitor~     patient condition remotely, without trial site visiting. Visit-free study design is~     potentially able to widen eligible patient population and to decrease patient dropout rate~     as well as burden of numerous assessments. Meanwhile assessment frequency could be increased~     enabling monitoring of short fluctuations in patients' condition.~      Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above~     issues are completely applicable. Direct current stimulation (DCS) of neural structures is~     well studied and safe intervention, however, its effects on SMA patients' strength and~     durability has not been reported for today. The investigators suppose that investigation of~     DCS action in SMA patient population is an adequate model for visit-free design feasibility,~     reliability and sensitivity evaluation.~   "
62817|NCT02235025|"~     The current definition of chronic obstructive pulmonary disease (COPD) is based on the~     presence of persistent airflow obstruction assessed by spirometry. About half of the~     subjects with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on~     forced vital capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with~     symptomatic mild COPD have reduced exercise tolerance and abnormal dynamic ventilatory~     mechanics compared to healthy subjects. The physiological and perceptual responses to~     exercise of subjects with asymptomatic mild COPD are currently unknown.~      The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal~     volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental~     cycle cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with~     symptomatic mild COPD and healthy controls.~   "
62818|NCT02235012|"~     Characterise cognitive biases resulting from low dose ketamine infusion, used as a~     pharmacological model of psychosis.~      Our assumption is that low dose ketamine results in reasoning biases by impairing the way~     uncertainty is monitored and taken into account for decision making.~   "
62819|NCT02234999|"~     To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects~   "
62820|NCT02234986|"~     The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a~     safe and effective treatment in patients with FLC. Safety will be measured by looking at the~     adverse events that may happen and the efficacy will look at the progression of the disease~     over time.~   "
62821|NCT02234973|"~     Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health~     outcomes compared to the general population because of a wide array of factors: social~     determinants of health, lifestyle, genetic susceptibility, and historic-political and~     psycho-social factors. Barriers to care that are unique to First Nations communities~     exacerbate the problem with fragmented healthcare, poor chronic disease management,~     healthcare staff turnover, and limited, or non-existent, surveillance.~      Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research~     program aims to develop and evaluate community-driven, culturally relevant, primary~     healthcare models that enhance chronic disease prevention and management in First Nations~     communities in Canada. Participants will consist of Indigenous community and clinic team~     members that will take part in multiple interrelated projects including community profiling,~     readiness consultations, diabetes registry and surveillance, and quality improvement~     workshops and action periods.~      Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical~     process and outcomes measures, 2) details about community-driven innovations, and 3)~     knowledge about the experience and cost of attempting to improve primary delivery in~     individual Indigenous communities.~      Intervention/Instrument: Survey, literature review, 15 month intervention (readiness~     consultations, implementation and maintenance of a registry and surveillance system,~     community and clinic focused quality improvement workshops), interviews.~      Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);~     Secondary-clinical process and outcome measures, change in stage of readiness, description~     of participation and innovation facilitators and barriers.~      Policy Implications: The outcomes of this research program have the potential to~     significantly affect future policy decisions pertaining to chronic disease care in First~     Nations communities. Policy recommendations will be made to help support Indigenous~     communities in adopting successful innovations to help address issues related to diabetes~     and other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and~     the subsequent policy decisions may enhance chronic disease prevention and management for~     Indigenous peoples across the country.~   "
62822|NCT02234960|"~     The aim of this non-interventional, prospective, observational study is to assess the~     effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic~     treatment in participants with moderate to severe active RA who are inadequate responders to~     disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to~     DMARDs, in a routine clinical practice setting in Poland. The length of the entire study~     will be 24 months.~   "
62823|NCT02234947|"~     Type 1 diabetes (T1D) is characterized by a progressive destruction of insulin producing~     beta cells, resulting in a lifelong dependence on exogenous insulin. While beta cells make~     up less than 1% of the pancreas, studies have demonstrated that T1D is associated with a~     marked reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if~     pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging),~     could be utilized as a marker of beta cell function in high risk patients, non-invasive~     pancreatic imaging could become an important part of staging diabetes risk. As such, the~     primary goal of this study is to measure pancreatic volume and compare differences in volume~     between new onset T1D patients, antibody positive subjects at risk for diabetes, antibody~     negative individuals, and healthy controls.~   "
62824|NCT02234934|"~     Chronic Granulomatous Disease (CGD) is an inherited immunodeficiency disorder which results~     from defects that prevent white blood cells from effectively killing bacteria, fungi and~     other microorganisms. Chronic granulomatous inflammation may compromise vital organs and~     account for additional morbidity. CGD is thought to affect approximately 1 in 200,000~     persons, although the real incidence might be higher due to under-diagnosis of milder~     phenotypes.~      The first gene therapy approaches in X-CGD have shown that effective gene therapy requires~     bone-marrow (BM) conditioning with chemotherapy to make space for the gene-modified cells to~     engraft. These studies demonstrated that transplantation of gene modified stem cells led to~     production of white blood cells that could clear existing infections. However, some trails~     using mouse-derived retroviral vectors were complicated by the development of myelodysplasia~     and leukemia-like growth of blood cells. This trial will evaluate a new lentiviral vector~     that may be able to correct the defect, but have much lower risk for the complication.~      This study is a prospective non-controlled, non-randomized Phase I/II clinical trial to~     assess the safety, feasibility and efficacy of cellular gene therapy in patients with~     chronic granulomatous disease using transplantation of autologous bone marrow CD34+ cells~     transduced ex vivo by the G1XCGD lentiviral vector containing the human CGD gene. Primary~     objectives include evaluation of safety and evaluation of efficacy by biochemical and~     functional reconstitution in progeny of engrafted cells and stability at 12 months.~     Secondary objectives include evaluation of clinical efficacy, longitudinal evaluation of~     clinical effect in terms of augmented immunity against bacterial and fungal infection,~     transduction of CD34+ hematopoietic cells from X-CGD patients by ex vivo lentivirus-mediated~     gene transfer, and evaluation of engraftment kinetics and stability. Approximately 3-5~     patients will be treated per site with a goal of 10 total patients to be treated with G1XCGD~     lentiviral vector.~   "
62825|NCT02234921|"~     This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.~   "
62836|NCT02234778|"~     The purpose of this study is to determine the safety and effectiveness of the Tissue~     Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™~     device removes certain cells from the adipose (fat) tissue which will be used to treat~     patients with blockages in the arteries of their lower legs that may require a future~     amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this~     study is to determine if treatment with cells that have been removed from the Icellator~     System™ device will reduce the number of major amputations and deaths in a six month time~     period.~   "
62900|NCT02233946|"~     The purpose of this study is to assess the psychometric properties of a brief screening~     questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians'~     offices, and to pilot test a personalized, computer-facilitated brief intervention delivered~     on a tablet computer and by the provider based on screening results.~   "
62901|NCT02233933|"~     Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and~     Hemospray in the therapy of bleeding from Radiation Proctitis~   "
62826|NCT02234908|"~     This pilot project is an evaluation of the feasibility, acceptability, and cost of offering~     an economic reward, in the form of a shopping voucher, to the household contacts of index~     patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the~     study clinic for TB screening and optional HIV testing, providing a reward to the index~     patients for participating, and entering index patients whose contacts do present into a~     lottery to win a prize. The reward of R50-R100 ($5-$10) will be large enough to encourage~     voluntary presentation at the clinic, but not so large as to be perceived as coercive to~     patients or unaffordable to the health system. The effectiveness of the intervention in~     screening a high proportion of contacts and its cost per contact screen and TB case~     diagnosed will be compared to existing published and unpublished data from studies of active~     case-finding through home visits and of the status quo passive case finding. If successful,~     this pilot project will create a demand for screening among high risk patients, who will be~     rewarded for identifying themselves to the healthcare system, and could prove to be an~     affordable alternative to resource-intensive home visits. It will also shift responsibility~     for contact tracing from overburdened clinic staff to those who have the most to gain from~     early case detection—the patients and their families.~   "
62827|NCT02234895|"~     Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of~     life and increased economic burden. Current research has focused on expensive, invasive~     treatments, whereas inexpensive conservative treatments have received less attention. One~     such treatment is the use of orthotics to reduce pain and increase function in people with~     knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and~     contradictory, and could benefit from more research taking into account foot posture. This~     study aims to compare the use of two orthotics designs in people with knee OA.~   "
62828|NCT02234882|"~     The purpose of this study is to assess the effect of the coadministration of multiple doses~     of BMS-663068 on the systemic exposure of rosuvastatin.~   "
62829|NCT02234869|"~     The primary objective of the study is to evaluate, in participants with RMS, safety and~     tolerability (as defined by the frequency of adverse events [AEs] of flu-like symptoms [FLS;~     chills, pyrexia, myalgia, and asthenia], injection site reactions [ISRs], and injection site~     reaction pain [ISR-P]) over 6 months of treatment (the active comparator period) with~     BIIB017 125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta~     (IFN-β) therapy. Secondary objectives of this study are to assess the following measures~     during the first (6-month) period of the study in participants treated with BIIB017 versus~     standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the~     following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire~     for Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ~     Side Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain~     Questionnaire Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs:~     Multiple Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5),~     EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity~     Questionnaire (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant~     adherence to study treatment, clinical status as measured by the Expanded Disability Status~     Scale (EDSS) and relapse activity, safety and tolerability of study treatment after a change~     in standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants~     changing from standard-of-care SC IFN-β to BIIB017.~   "
62830|NCT02234856|"~     This study aims to test the validity of a new educational tool in the form of a computer~     based video surgical simulator, that may be used to enhance the current teaching method of~     how to perform a hysterectomy.~   "
62831|NCT02234843|"~     The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to~     standard of care in children with acute venous thromboembolism.~   "
62832|NCT02234830|"~     Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence~     of adverse access site related events at 30 days.~   "
62833|NCT02234817|"~     Falls are dangerous leading to injuries and even death. The VA has made fall prevention a~     priority but effective programs only reduce falls by 30%. Tai Chi, a standing exercise~     program, has been effective at improving balance but may not prevent falls. Most falls occur~     during walking when an individual experiences a slip or a trip. Programs that focus on~     walking, stepping, and recovery from a slip may be more effective at fall reduction. This~     study will compare Tai Chi to the investigators new multimodal balance intervention (MMBI).~     MMBI focuses on standing balance, walking, stepping, strength training, and recovery from a~     slip. A multimodal program will most likely be more effective than Tai Chi at improving~     balance and preventing falls in older Veterans and the investigators will use the results of~     this study to develop a larger study on fall prevention in older Veterans.~   "
62834|NCT02234804|"~     Prospective, controlled, double randomized, non-blinded, multicenter, investigator~     initiated, academic superiority trial comparing optical coherence tomography (OCT) guided~     vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization~     1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent~     strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary~     endpoint and 30 days clinical follow-up.~      Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed~     struts in the segment facing the SB ostium.~      Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less~     malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience~     Prime stent.~   "
62835|NCT02234791|"~     X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected~     patients have very low levels of peripheral B cells and a profound deficiency of all~     immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk)~     are responsible for most of the gammaglobulinemia.~      We tend to investigate the gene mutation and clinical features of Chinese X-linked~     agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk~     gene mutations and severity of clinical presentation.~   "
62902|NCT02233920|"~     Study to obtain further information on the tolerability and efficacy of Ventilat®~     metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of~     daily practice~   "
62903|NCT02233907|"~     Study to obtain further information on the tolerability and efficacy of Ventilat® metered~     dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under~     conditions of daily practice~   "
62837|NCT02234765|"~     Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive~     sleepiness secondary to repeated obstruction of the upper airway during sleep and~     cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders.~     Epidemiological studies in our country have shown that OSA is a highly prevalent disease in~     the general population, affecting 2-4% of the adult population. The most important clinical~     manifestations of OSAS is a deterioration in the quality of life and an increase in~     cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and~     considering the medical complications of OSA, as well as the sociolaboral impact and its~     negative impact on quality of life and survival; is stated that this disease is a public~     health problem that requires the physician to identify patients eligible to treatment.~     Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health~     resources, comparing when the diagnosis and treatment has been established. Finally, we have~     a highly effective treatment using positive pressure in the upper airway (CPAP) that has~     been shown to be effective and cost-effective. The current situation in which all patients~     diagnosed with OSA and receiving different treatments are monitored and controlled by the~     Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC).~     Our working hypothesis is: By the coordination of actions at various levels including~     interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records~     and the use of new technologies can be achieved in AP satisfactory management of the~     diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both~     areas have a level of clinical response, satisfaction, compliance and avoidance of~     complications, similar to that obtained with monitoring by SU. In addition, management by AP~     will be more cost-effective than in the SU.~   "
62838|NCT02234752|"~     Aim: To examine the efficacy of the combination of galantamine and memantine for the~     treatment of cognitive deficits in outpatients with schizophrenia.~      Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in~     patients with schizophrenia.~      This is an open-label study to evaluate whether a six week course of galantamine ER and~     memantine XR is effective in improving the cognitive performance of patients with~     schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in~     level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The~     results of the MATRICS collaborative project recommended the need for standardized cognitive~     tests that better distinguish the different facets of cognitive dysfunction in~     schizophrenia. The MCCB will assess the following seven domains: attention/vigilance,~     reasoning and problem solving, processing speed, social cognition, verbal learning and~     memory, visual learning and memory, and working memory. The MCCB will be administered at~     baseline and at the end of the study. We will report total score and each domain score in~     the MCCB at baseline and six weeks.~   "
62839|NCT02234739|"~     voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis,~     however the efficacy and safety of voriconazole for treating invasive pulmonary~     aspergillosis secondary to COPD is not clear. This study aims to investigate the~     effectiveness and tolerability of intravenous voriconazole for treatment of invasive~     pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical~     symptoms, eradication of aspergillus, improvement of chest imaging as well as record of~     possible adverse reactions following 2-week intravenous instillation of voriconazole.~   "
62840|NCT02234726|"~     The purpose of this study is to evaluate the impact of a community-based early childhood~     development (ECD) program on children's physical and cognitive development. Under the~     program, targeted communities will be assigned a trained Child Development Agent (CDA) who~     will have four main tasks and responsibilities: 1) biweekly screening and management~     (including referral) of acute malnutrition in children; 2) encouragement of caregivers to~     utilize routine care services for children; 3) screening for symptoms of acute diseases~     including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4)~     organization and mentoring of biweekly caregiver meetings to discuss parenting and promote~     early childhood cognitive stimulation. The investigators will enroll at baseline around 600~     children ages 6 - 12 months and their caregivers, and randomize them at the community-level~     to receive the ECD program or to remain in the control group. The study period will be one~     year. At end line, the investigators will collect important indicators of child physical and~     cognitive development to assess program impact. If the program shows both feasibility and~     impact, there is the potential to integrate program interventions into existing national~     community-based health initiatives.~   "
62841|NCT02234713|"~     Disease modifying therapies (DMT) are widely used for children and adolescents with MS.~     Nonetheless, many pediatric patients continue to relapse and therefore require changes in~     therapy. We designed this research study to learn more about medication use in children and~     adolescents with MS. We are also interested in learning what a behavioral feedback~     intervention can tell us about adherence to medicine. Finally, we hope this research project~     will inform the way we provide clinical care for children and adolescents with MS.~   "
62842|NCT02234700|"~     Comparison between patients with nasolacrimal duct obstruction and healthy patients and the~     influence of their bacterial flora on the corneal epithelium.~   "
62843|NCT02234687|"~     In this study, we propose to employ a randomized, double-blind, placebo-controlled,~     outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40~     mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating~     fear-potentiated startle response and behavior in adults with post-traumatic stress disorder~     (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160~     mg vs placebo in a 1:1:1 ratio).~   "
62844|NCT02234674|"~     This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a~     leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).~      This study is a pilot controlled randomized study with two arms.~   "
62845|NCT02234661|"~     The CAP Family Advancement Study (CAP FAST) is a randomized control trial of CareerAdvance®,~     a dual-generation program providing education, career coaching, and soft-skills training for~     parents while their children attend CAP Tulsa's Head Start programs.~   "
62873|NCT02234297|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and~     reduced patient survival. In some sites, such as the brain, it is critical to avoid damage~     to normal tissue around the tumor to prevent adverse effects of surgery on function. We~     hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize~     the edges of the tumor and small groups of cancer cells that have spread to other sites in~     real-time as operate. This is a safety study to assess the safety of BLZ-100 in patients~     with gliomas undergoing surgery.~   "
62846|NCT02234648|"~     Given the global health issues associated with poor cardiovascular function, interventions~     that help reduce the severity, with emphasis on prevention would not only have economic~     implications, but would also improve health, wellbeing and quality of life. Research~     provides evidence that consumption of a diet high in plant foods and rich is polyphenols is~     associated with a reduction in the incidence of cardiovascular disease (Hung et al 2004).~     Tart Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al~     1999; Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve~     blood vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012),~     reducing vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et~     al 2006) and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of~     the lining of blood vessels (endothelial dysfunction) has been linked to increased risk of~     cardiovascular disease. However, the bioavailability of all the compounds in Tart~     Montmorency Cherry Juice and their efficacy with respect to vascular function has not been~     fully determined. This study will examine the influence of tart Montmorency cherry juice on~     cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood~     flow in the microcirculation by laser Doppler imaging. This study will also examine digital~     volume pulse and pulse wave analysis. These data will provide information on the ability of~     TMCJ to affect blood flow and vascular function.~   "
62847|NCT02234635|"~     In this study, the investigators examined the subjective visual quality including LogMAR~     uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity~     (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate~     visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near~     visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality~     including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index~     (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time~     and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical~     quality analysis system (OQAS).~   "
62848|NCT02234622|"~     Given the limited effectiveness of current treatments and the burden PTSD places on Veterans~     and clinicians, this research aims to compare the effects of a standardized, traditional,~     holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation~     practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.~   "
62849|NCT02234609|"~     Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment~     in many developing countries. Because, ART is intended to be operated in molars, and about~     10% of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was~     the aim of this study to clinically evaluate a modified ART restoration technique for~     anterior teeth as the traditional treatment approach did not show satisfying clinical~     results.~   "
62850|NCT02234596|"~     This is a phase II study of Nintedanib in patients with metastatic or recurrent~     esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an~     orally available triple kinase inhibitor targeting the receptors of the vascular endothelial~     growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor~     (FGF) receptor pathways.~   "
62851|NCT02234583|"~     This is an open-label study of DS-5565 in subjects who either completed participation in a~     preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309, DS5565-A-E310,~     or DS5565-A-E311 or are de novo subjects. Eligible subjects will be assigned to receive~     open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for~     the first three weeks of the treatment period. After three weeks, subjects may be titrated~     to 15 mg twice daily (BID) based on protocol-specified criteria.~   "
62852|NCT02234570|"~     The objectives of the Phase I study are to evaluate the safety and tolerance of increasing~     single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the~     pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The~     description of agent used is single oral dose of an aqueous suspension of oxfendazole, a~     benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two~     week safety data for the preceding group have been reviewed. If a clinically significant AE~     is observed, and if this event is drug-related the safety monitoring committee will be~     convened to determine whether the study should continue.~   "
62853|NCT02234557|"~     Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal~     impact, and the effectiveness of current standard treatments is limited. We examine a novel~     treatment that could remediate the core features of ADHD and thereby contribute to sustained~     improvements in behavioral control. This approach is motivated by mounting evidence that~     children with ADHD show difficulties with motor control, and that these motor deficits are~     strongly associated with the core behavioral features of ADHD. We employ Tai Chi, targeting~     improvements in well-established behavioral and physiologic measures of motor control, and~     with this, improvements in ADHD symptoms. The proposed study offers immense potential for~     the development of novel therapeutic approaches for ADHD with little risk of adverse~     reaction.~      The over-arching goal of this proposal is to examine a movement-based mindfulness training~     as a therapeutic intervention for children with ADHD. This approach is motivated by two~     complimentary lines of evidence: 1) Children with ADHD show impairments in motor control~     that parallel (and correlate with) core deficits in behavioral control that define the~     disorder. 2) Gains in cognitive and behavioral control have been observed in adults learning~     Tai Chi, dance, or meditation. These lines of evidence provide substantial motivation for~     our proposed investigation of movement-based mindfulness training in children with ADHD.~     Specifically, we propose to evaluate an established Tai Chi-based intervention. We chose~     this approach for a number of reasons: 1) Tai Chi is among the most well-established~     movement-based interventions with documented therapeutic effects, including cognitive~     effects. 2) While many movement-based approaches show evidence of yielding cognitive~     improvements Tai Chi provides excellent opportunities for engagement of 8-12 year old~     children in the form of the collaborative game push hands. 3) Tai Chi instruction consists~     of gentle movements that can be practiced even by those with physical limitations, and is~     readily available in the United States so the protocols developed in this study will be~     straightforward to deploy at a national level.~      Hypothesis: After participating in a Tai Chi program, children with ADHD will show~     improvements in behavioral and physiologic measures of motor control. We further expect~     movement-based training will result in decreases in ADHD symptom severity.~   "
62854|NCT02234544|"~     Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a~     single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.~      Differences between the serum levels of 25(OH)D in response to cholecalciferol plus~     ezetimibe compared to cholecalciferol plus placebo.~   "
62855|NCT02234531|"~     The aim of the project is to assess whether the continuous visualization of on-line teacher~     in virtual reality (VR) is effective for the improvement of upper limb motor function, in~     stroke patients.~   "
62904|NCT02233894|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets~     in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
62856|NCT02234518|"~     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the~     major contributors to GI discomfort is constipation, which has a prevalence of ~15% and~     symptoms of which have a significant negative impact on the sufferer's quality of life. One~     of the hallmarks of chronic constipation is slow progression of contents through the gut~     (i.e. slow gut / colonic transit time), which may be associated with hard stools that are~     difficult to expel.~      Dietary fiber supplements are widely used as a first-line treatment for constipation~     although little Level 1 evidence exists to support its use in adults. The effectiveness of~     different fiber supplements is difficult to compare given wide differences in~     water-retention capabilities and effects on the colonic microbial ecology. Given the~     promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of~     functional constipation, the objective of this clinical trial is to evaluate tolerance and~     effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on~     whole gut transit time and gastrointestinal symptoms in adults with functional constipation.~   "
62857|NCT02234505|"~     In human gait there is a certain amount of variation between steps; some considered~     physiological and owed to variations in environment or posture, and some severe enough to be~     indicative of gait instabilities that may lead to stumbling and falling. In users of lower~     limb prosthetics, such gait instabilities are of especially great interest.~      The study investigates the correlation between socket alignment quality and gait~     step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a~     clearly defined range of step-by-step variability exists, and that therefore step-by-step~     variability is suitable as an outcome variable for the assessment of socket alignment.~      A sample of ten persons with trans-tibial amputation will be recruited for this pilot study.~     Subjects will be asked to walk on different natural surfaces while the socket alignment is~     successively perturbed. Step-by-step variations in horizontal ground reaction forces and~     torsional moments will be measured and statistically compared.~   "
62858|NCT02234492|"~     The purpose of this study is to determine whether the use of rosuvastatin in Human~     Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels,~     improves blood circulation in the small arteries that provide nutrients to the heart muscle~     and improves neurocognitive function.~   "
62859|NCT02234479|"~     The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation~     dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It~     is hoped that the outcome of this pilot study will provide evidence supporting the use of~     Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary~     data to expand this study to larger, federally funded research (R01) looking at the~     beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in~     several disease settings.~   "
62860|NCT02234466|"~     Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the~     improvement of quality of recovery from surgery. The study population is limited to breast~     surgery patients. The investigators will also look at the effect of our intervention on post~     operative nausea and vomiting.~      Patients will be recruited before the date of their surgery and will complete the Quality of~     Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will~     also complete a Clinically significant nausea and vomiting score upon discharge from the~     post anesthesia recovery room, repeated at 24 hours post op.~   "
62861|NCT02234453|"~     The investigators hypothesise that cancer patients on systemic anticancer therapy can~     measure a home blood count, temperature, record qualitative data and transfer the results~     electronically to the hospital clinical team.~      A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic~     anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis.~     Neutrophil count is usually obtained by venepuncture by a health-care professional. The~     Minicare H-2000 is a new device which facilitates home self-testing of blood count,~     temperature and symptoms. The four components are i) blood count recorder using a capillary~     sample obtained via finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting~     patient-reported outcomes and iv) secure communication through the 3G network.~      The investigators propose a single-centre, non-randomised feasibility study to test the~     process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood~     count readings, temperature and qualitative data electronically to the hospital clinical~     team. The aim is to test training of patients to use a finger-prick method of obtaining~     blood count, patient ability to perform the test, retention of training, the ability of the~     Minicare H-2000 to facilitate the data transfer and to test the secondary care interface.~     This study will provide preliminary data on the potential of Minicare H-2000 to prevent~     wasted hospital journeys when the blood count has not recovered sufficiently for subsequent~     SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80~     patients to this study which will be performed in addition to current local standard of~     care.~      This study enables identification of suboptimal areas of the process prior to investigating~     the application of the minicare H-2000 within oncology to improve the clinical patient~     pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to~     reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys~     and hospital resources, reduce non-elective hospital admissions and personalise delivery of~     SACT.~   "
62862|NCT02234440|"~     In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis),~     coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or~     getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria~     and consent of the patient. These patients will be randomised to either metformin arm or~     conventional treatment arm. After enrollment these subjects will be monitored every three~     monthly for total of 12 months or till the primary endpoint is achieved. At the end of the~     study, outcome will be measured appropriately.~   "
62863|NCT02234427|"~     This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene~     expression in persons at high-risk of developing heart attacks due to family history of~     early-onset coronary artery disease~   "
62874|NCT02234284|"~     This proposed study will examine whether health coaches can improve the management of COPD~     in a population of vulnerable patients cared for in 'safety-net' clinics. The study is~     designed as a randomized controlled trial for patients with moderate to severe COPD.~     Patients will be randomized into a health coaching group and a usual care group. Those in~     the health coaching group will receive 9 months of active health coaching. Outcome variables~     will be measured at baseline and after 9 months~   "
62875|NCT02234271|"~     The primary objective of the investigators study was to design a comprehensive and medically~     accurate contraception counseling mobile health application and evaluate the effects of this~     contraception counseling application on the contraceptive methods that patients selected and~     their knowledge of that method.~   "
62905|NCT02233881|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets~     in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
62864|NCT02234414|"~     In Switzerland, the prevalence of vertebral fractures in community- dwelling women is~     unknown and the published data from the Swiss hospitals statistics represent only the tip of~     the iceberg. In addition, the percentages of women correctly identified with vertebral~     fractures due to osteoporosis and the treatment rate of these women with a drug proven to~     reduce the risk of further fractures are unknown. Furthermore, it is not known whether the~     prevalence of vertebral fractures differs between urban and rural areas or between mountain~     areas and plain country, e.g. due to possible differences in sun exposure (vitamin D~     production) and/ or in physical activity and/ or dietary habits.~      Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either~     sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a~     combination of both would improve sensitivity and specificity is unknown.~      The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and~     lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings,~     a retrospective study of hospitalized elderly patients has shown that as many as 50% of the~     radiographic reports failed to note the presence of moderate to severe vertebral fractures.~     In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or~     vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug~     treatment was offered to only 36% of the diagnosed patients.~      The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA~     measurements allows for the detection of vertebral deformities, which is critical for~     management of osteoporosis, as the existence of such deformities substantially increases the~     risk of subsequent fracture. Recently published results show that VFA allows the diagnosis~     of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures~     compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures,~     ranging between 90-94%.~   "
62865|NCT02234401|"~     Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years~     (UK CF Registry 2011). The commonest cause of death is respiratory failure.~      Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement~     the size and depth of each breath. It is introduced in CF to manage established respiratory~     failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation,~     is used just at night, or for part of the day in addition or for 24 hours as clinical status~     indicates. It is introduced within a normal ward environment and then continued longterm at~     home.Once respiratory failure is established longterm noninvasive ventilation is introduced~     throughout 24 hours and multidisciplinary assessment concludes that the timing is~     appropriate for the individual.~      This study aims to evaluate a potential development of current practice: the use of non~     invasive ventilation during hospital admission only to enhance recovery from an acute~     exacerbation which has caused respiratory failure in those individuals where long term non~     invasive ventilation is not yet indicated. A mixed methods design will allow description of~     the experience of noninvasive ventilation during a semistructured interview to add to~     understanding of the results from an experiment designed to measure the differences between~     noninvasive ventilation and standard care.~      Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an~     acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.~   "
62866|NCT02234388|"~     This registry has been established to gain a better understanding of the clinical and~     emotional presentations of patients with undifferentiated connective tissue disease.~   "
62867|NCT02234375|"~     The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who~     have a contraindication to iodine based contrast. These patients normally get investigated~     with studies such as ultrasound and nuclear medicine studies but the fastest and preferred~     investigation is CT with contrast to look for filling defects in the pulmonary arteries. The~     investigators will assess whether gadolinium, which is currently used with MRI can be used~     with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of~     CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium~     contrast on CT.~   "
62868|NCT02234362|"~     The broad goal of this study is to examine the efficacy and tolerability of vortioxetine~     (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women~     around the menopausal transition. We hypothesize that an eight-week treatment with~     vortioxetine will promote a significant improvement of depression symptoms and other~     menopause-related physical symptoms.~   "
62869|NCT02234349|"~     Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic~     patients with chronic kidney disease and improves patients' outcome. However, in spite of an~     optimized systemic insulin substitution, altered glucose metabolism and beta cell function~     are reported in these patients. The mechanisms behind these abnormalities are still unclear.~     Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could~     change physical and chemical properties of intestinal secretions, gut flora, as well as~     intestinal permeability. The effect of this procedure on gut derived metabolic factors, the~     enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been~     studied. This pilot prospective, study is aimed to evaluate the modification of bile acids~     concentrations and composition in PKT subjects, and the impact in glucose and incretin~     metabolism (measured by oral glucose tolerance test) one year after transplantation. The~     results will be compared to those of kidney transplant patients and control subjects.~   "
62870|NCT02234336|"~     Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and~     prognostic importance given its known association with sudden cardiac death. However, data~     regarding comparison of imaging modalities for this key measurement is lacking. This study~     seeks to compare assessment of maximum wall thickness between clinically indicated~     echocardiography (with and without contrast) and clinically indicated cardiac magnetic~     resonance imaging.~   "
62871|NCT02234323|"~     The primary objective of the study is to evaluate the safety of rFVIIIFc (BIIB031) in~     previously untreated participants with severe hemophilia A. The secondary objectives are to~     evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in~     previously untreated patients (PUPs), to evaluate rFVIIIFc consumption for the prevention~     and treatment of bleeding episodes in PUPs, and to describe experience with the use of~     rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.~   "
62872|NCT02234310|"~     The primary objective of the study is to evaluate the safety of rFIXFc (recombinant~     coagulation factor IX Fc fusion protein, BIIB029) in previously untreated participants with~     severe hemophilia B. Secondary objectives are to evaluate the efficacy of rFIXFc in the~     prevention and treatment of bleeding episodes in previously untreated participants (PUPs),~     and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in~     previously untreated participants.~   "
62886|NCT02234128|"~     This is a safety study to compare the safety of receiving a lung treated with the Toronto~     EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung~     transplantation.~   "
62876|NCT02234258|"~     Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses~     that incur substantial suffering for patients and major challenges to the investigators~     health care and legal systems. The prodrome is the period prior to onset of psychosis when~     functional decline and clinical symptoms gradually emerge. The presence of a clinical~     high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the~     later development of psychosis, and for those who do not necessarily go on to develop a~     psychotic illness, research has suggested that the majority continue to have fluctuating~     subthreshold symptoms and poor social and role functioning. There are no specific treatments~     to help with these functional difficulties. However, recent findings suggest that in people~     with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to~     significantly greater increase in the frequency of social functioning activities compared to~     treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is~     a feasible treatment for CHR. This proposal is a competitive application for a three-site,~     longitudinal study aimed at testing the effectiveness and feasibility as well as mediators~     and mechanisms of action of a manualized CBSST intervention that will target functional~     difficulties associated with clinical risk states for psychosis. The goals are 1) to examine~     whether CBSST compared to a placebo intervention (psychoeducation) matched for group~     involvement and therapist time improves functioning in youth at CHR and 2) to determine~     whether reduction in defeatist beliefs and improvement in social competence mediate change~     in psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm~     trial participants will be randomized to one of two treatments: CBSST, an 18-week group~     comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving,~     or a psychoeducation support group that does not teach active cognitive behavioral therapy~     or social skills training. Over a five-year period, the multi-site collaboration will follow~     large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral~     changes, to examine changes in social and role functioning, as well as symptom changes from~     baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate~     the feasibility of a treatment for which it is easy to train therapists and which can~     readily be disseminated to regular clinical community practice. In addition, it will provide~     insights into likely approaches to halting or mitigating the pathological process and~     advance the investigators understanding of risk prediction; both critical steps in~     prevention.~   "
62877|NCT02234245|"~     The purpose of this research is to estimate the outcomes in health and cost of the follow-up~     of patients with pacemakers.~      The initial hypothesize of this study is that remote monitoring of pacemaker will show a~     best relation of outcomes in costs and effectiveness than the conventional follow-up in~     hospital.~   "
62878|NCT02234232|"~     The primary aim of this pilot study is to evaluate the feasibility and safety of four~     different types of intradialytic exercise (exercise performed during dialysis) programs:~     resistance, aerobic, combined resistance and aerobic, and flexibility (attention control).~     The secondary aim of the study is to estimate the effect of aerobic and resistance exercise,~     each compared with the attention control on: health-related quality of life, tests of~     physical performance, strength, and physical activity outside of the dialysis unit. The~     results of this study will be used to inform the planning of a full-scale efficacy study.~   "
62879|NCT02234219|"~     Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.~   "
62880|NCT02234206|"~     This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in~     40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25~     ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum~     verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium~     fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,~     Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,~     Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna~     prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,~     Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera~     sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted~     in India (Chennai). Primary outcome measure is to see the changes in sperm count, motility~     and morphology. Secondary Outcome measure is to see the impact on the harmone level.~   "
62881|NCT02234193|"~     The investigators are doing this research study to learn about how the skin heals after many~     microscopic skin biopsies are collected.~      Skin-grafting is a life-saving procedure for people with large area skin wounds caused by~     burns or trauma. Conventional autologous (self) skin grafting techniques require the~     creation of large donor site wounds, causing numerous complications including pain,~     infection, blistering, discoloration, and scarring. Based on previous research, many of~     these adverse effects can be improved, or even eliminated, by harvesting skin tissue in very~     small biopsies. These micro-biopsies are less than the size of a sewing pin. Then, they~     are put back together into a skin graft.~      This concept is based on clinical observations from fractional photothermolysis laser~     therapy, an FDA approved laser that has been previously developed by the investigators~     research group for the treatment of scars and ageing skin. With this laser technique,~     thousands to millions of small burns are produced by laser on a patient's skin, and the skin~     responds by healing the damaged areas to create new healthy skin within days and without~     scarring.~      Although the results of laser treatment are well-known, it is not known what happens when we~     harvest the skin using needles instead of using the laser to cut the skin. The investigators~     also would like to understand how the body heals the skin. Understanding how this works~     helps in understanding wound healing, and may lead to future treatments for healing large~     wounds, disfiguring burn scars, and preventing scar formation.~      A tummy tuck (abdominoplasty surgery) is done to remove excessive skin of the belly. This is~     an elective surgery, in other words, it is optional and usually done for cosmetics reasons~     (to improve the appearance).~      The skin of the belly that is removed during an abdominoplasty surgery (tummy tuck) is~     discarded. The skin of the area removed is called pre-abdominoplasty skin. The~     investigators would like to study the effects of the micro-biopsies on pre-abdominoplasty~     skin to exam how the skin heals over time and to study the skin that will be removed during~     the abdominoplasty surgery.~      This is a pilot study. Pilot studies are done on a small group of subjects to learn if a~     larger study would be useful.~      The investigators are asking subjects to take part in this study who are healthy with an~     abdominoplasty surgery (tummy tuck) scheduled at Massachusetts General Hospital (MGH) by a~     plastic surgeon .~      The investigators will enroll about 28 subjects in this research study, all at MGH.~      The Department of Defense is paying for this study to be done.~   "
62882|NCT02234180|"~     This randomized phase II trial studies how well regorafenib works in treating patients with~     cancer of the esophagus or gastroesophageal junction that has spread from where it started~     to nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery.~     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
62883|NCT02234167|"~     The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was~     called The Social Medicine Remand Prison Project is to target injecting drug users (IDU)~     with primary and secondary health interventions with regards to injecting and sexual risk~     behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted~     infections (STI).~      The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk~     behaviour and disease outcome among IDUs over time.~   "
62884|NCT02234154|"~     This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain~     for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.~   "
62885|NCT02234141|"~     This study will compare the efficacy, safety, and tolerability of three doses of selonsertib~     (GS-4997) to placebo in adults with pulmonary arterial hypertension (PAH). The study will~     consist of a 24-week placebo-controlled treatment period and a long-term selonsertib~     treatment period. Participants completing the 24-week placebo-controlled period will be~     eligible to receive active treatment with selonsertib in the long-term treatment period.~   "
62888|NCT02234102|"~     The study aims to compare the results of pulmonary vein isolation (PVI) with a single~     technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with~     patients who have persistent AF of less than 3 months. Many studies have shown that~     electrical reconnection of the pulmonary veins following the index procedure can occur in up~     to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser~     ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe~     and effective and has also shown promising rates of durable isolation compared to point by~     point radio frequency techniques. However, the impact of employing this technique for~     patients with persistent AF has not yet been reported. The study hypothesis is that there~     will be no statistically significant difference between the results of PVI in the two groups~     of patients.~   "
62889|NCT02234089|"~     The purpose of this study is to detect factors influencing decision making for treatment~     pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving~     medicinal androgen deprivation therapy (Degarelix or LHRH agonists).~   "
62890|NCT02234076|"~     Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with~     posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent~     Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which~     psychotherapy is widely practiced. Depression is one of the most common co morbid disorders~     when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event~     often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and~     depression have been related to a reduced specificity in autobiographical memory.~      Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET)~     in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It~     will also attempt to develop protocols to implement this new technology into clinical~     practice and collect data to develop a treatment progress prediction model.~      Study design: A randomized controlled intervention study.~      Study population: 144 individuals with memories of CSA or war related trauma and symptoms of~     PTSD and/or depression.~      Intervention: VRET or TAU.~   "
62891|NCT02234063|"~     In this genomic medicine implementation pilot project, the investigators aim to conduct a~     randomized trial in a network of community health centers and primary care facilities to~     study processes, effects and challenges of incorporating information for apolipoprotein L1~     (APOL1)-attributable genetic risk for end stage kidney disease in patients of African~     ancestry with hypertension .~   "
62892|NCT02234050|"~     The aim of this study is to collect data on activity, toxicity and quality of life of~     trabectedin therapy in patients with recurrent high-grade meningioma.~   "
62893|NCT02234037|"~     STUDY BACKGROUND AND PURPOSE:~      Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more~     common with increasing age. AML is harder to treat in older patients, with typically poor~     responses to standard chemotherapy.~      Patients with AML are typically given intensive induction chemotherapy, but many older~     patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be~     active and better tolerated in frail patients with AML; however, most patients still~     relapse.~      Recent studies suggest that improving the performance status and fitness of older AML~     patients prior to induction chemotherapy may help to lessen side effects.~      This study will test the combination of decitabine treatment with physical exercise in~     elderly patients with AML who are not candidates for standard induction chemotherapy.~      STUDY DESCRIPTION:~      This is a pilot study to test the combination of decitabine treatment with an 8-week~     physical exercise program in AML patients ≥ 60 years of age who are not candidates for~     standard induction chemotherapy. Patients who are eligible to take part must give their~     written agreement before they can be enrolled.~      This study will enroll 20 patients who are not candidates for standard induction~     chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3~     sessions per week supervised by a physical therapist. During this 8-week period, patients~     will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a~     28-day cycle).~      Patients will be followed to assess the safety and tolerability of the program. Patients~     will also give blood samples that will be used to assess their response to treatment.~     Patients will be evaluated for their physical fitness before and after the 8-week exercise~     program and will complete questionnaires to assess their quality of life before and after~     the program.~   "
62894|NCT02234024|"~     The purpose of this pilot project is to see if a supplemental form of dietary gangliosides~     can serve as a potential treatment for the rare metabolic condition called ganglioside GM3~     synthase deficiency.~   "
62895|NCT02234011|"~     This study is being done to learn whether administration of intranasal (inhaled through the~     nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been~     approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine~     to reduce pain during surgery and other procedures) but ketamine has not been approved by~     the FDA as a treatment for OCD.~      The investigators believe that ketamine may be effective in reducing symptoms of OCD due to~     its ability to decrease the activity of a specific brain chemical called glutamate. Previous~     studies have shown that people with OCD can have abnormal levels of glutamate in their~     brains. This is the first time that intranasal ketamine is being studied in people with OCD.~     However, studies have been done in the past using intravenous (IV; through a needle into a~     vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in~     people with other psychiatric conditions.~      This research study will compare ketamine to placebo. The placebo looks exactly like~     ketamine, but contains no ketamine. At some time during the study, the investigators will~     give you ketamine. At another time, the investigators will give you placebo. Placebos are~     used in research studies to see if the results are due to the study drug or due to other~     reasons.~   "
62896|NCT02233998|"~     The reduction of existing plaque and gum inflammation will be evaluated using two marketed~     mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth~     rinse.~      165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to~     be in this study will have an equal chance of being assigned to one of the three treatment~     groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1~     2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will~     maintain a diary at home to record each treatment use and will be asked to come to the~     clinic without brushing or use their product for at least 8 hours, but no more than 18~     hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments~     will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.~   "
62897|NCT02233985|"~     - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate~     to severe bronchiolitis.~   "
62898|NCT02233972|"~     This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the~     purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection~     to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic~     parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.~   "
62906|NCT02233868|"~     Background:~      - Brain inflammation due to high alcohol intake may affect thinking, memory, and~     concentration. Researchers want to measure this using positron emission tomography (PET).~      Objective:~      - To study how excessive alcohol consumption affects brain function.~      Eligibility:~        -  Adults 30-75 years old who are moderate or severe alcohol drinkers.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, interview, and blood~          and urine tests. Their breath will be tested for alcohol and recent smoking.~        -  Phase 1:~        -  Participants will stay in the hospital 3 days. They will have blood and heart tests and~          daily urine tests.~        -  A small plastic tube will be inserted by needle in each arm. One will go in a vein, the~          other in an artery.~        -  Participants will have 2 PET scans with 2 different radioactive compounds. Participants~          will lie on a bed that slides in and out of the scanner with a cap on their head.~        -  Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in~          the scanner either resting with their eyes open or while performing an attention task.~        -  Participants will have tests of memory, attention, concentration, and thinking. They~          may answer questions, take tests, and perform simple actions.~        -  Phase 2 of the study will only be done if Phase 1 results show brain inflammation.~        -  Phase 2 will repeat Phase 1.~        -  For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1.~        -  Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up~          to 4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up~          calls over 3 months.~   "
62907|NCT02233855|"~     Background:~      - Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to~     serious brain problems such as seizures, sevre headaches and difficulties with movements or~     sensation in the limbs. Researchers want to learn more about the different ways in which~     people in the United States present with this disease and how they respond to standard and~     newer treatments.~      Objective:~      - To learn about the different forms of NCC that occurs throughout North America and how~     patients with these forms respond to treatment.~      Eligibility:~      - Adults age 18 or older with NCC.~      Design:~        -  Participants will be screened with:~        -  Medical history and physical exam.~        -  A computed tomography (CT) brain scan The participant will lie still on a table that~          slides into a large donut-shaped scanner.~        -  Blood drawn through an arm vein for analysis~        -  A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a~          long metal cylinder as the machine makes images of the body. During the scan,~          participants will receive a contrast agent through an IV that allows high resolution~          imaging of the brain and spine~        -  Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and~          depending on the need for monitoring, more times. Participants will receive a schedule~          that will explain the procedures done at each visit.~        -  At these visits, participants may:~        -  Repeat the screening procedures.~        -  Be asked about their NCC symptoms and their physical and mental health.~        -  Have a urine test.~        -  Take a test of their ability to concentrate, their memory and spatial recognition.~        -  Have a lumbar puncture, if indicated by the state and severity of infection. A needle~          will be inserted through the skin and into the space between the bones in the back.~          Cerebrospinal fluid will be removed.~   "
62908|NCT02233842|"~     Background:~      - People who have cancer have more medical problems if they smoke. Some studies show that~     smoking even makes cancer treatment less effective. Researchers want to teach people about~     how tobacco use affects people after a cancer diagnosis. They want to come up with questions~     for people who have cancer and who have survived cancer. The questions will be about using~     cigarettes and other tobacco products and about second-hand smoke.~      The questions will be used to understand how using tobacco affects people with cancer~     before, during, and after treatment. This will help doctors plan how to treat people with~     cancer and create programs to help people quit smoking in the future.~      Objective:~      - To evaluate and refine questions that assess tobacco use.~      Eligibility:~      - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any~     site and any stage.~      Design:~        -  This study will take about 1 hour.~        -  Participants will meet one-on-one with an interviewer. They will fill out a~          questionnaire and talk about the questions. Participants will explain how easy or hard~          it was to answer the questions and how they decided on their answers.~        -  All participants will be asked the same or very similar questions. Specific questions~          will be based on the participants own experiences with tobacco products.~        -  There will be no follow-up activities.~   "
62909|NCT02233829|"~     Background:~      - Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make~     these effects sensitive to the time of day they are taken. Cocaine can affect these genes in~     the brain. Researchers want to measure brain dopamine at different times of day.~      Objectives:~      - To look for changes to a person s biological clock in the function of the dopamine reward~     system. To test if cocaine disrupts this.~      Eligibility:~        -  Adults age 21-55 with a cocaine use disorder.~        -  Healthy volunteers age 21-55.~      Design:~        -  Participants will be screened with medical history, physical exam, interview, and blood~          and urine tests. Their breath will be tested for alcohol and recent smoking.~        -  Participants will have 3 overnight clinic visits.~        -  Visit 1: They will have blood and urine collected and a heart test.~        -  A plastic tube (catheter) will be placed into a vein in each arm by needle.~        -  Participants will have a PET scan in a donut-shaped machine. They will lie on a bed~          that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a~          drug (blocks dopamine removal) will be injected via catheter. Vital signs will be~          measured and blood will be drawn throughout.~        -  Visit 2: repeats Visit 1, except at night.~        -  Visit 3, participants will have urine collected.~        -  They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will~          lie on a table that slides in and out of it, with a coil over their head.~        -  Participants may answer questions, take computer or paper tests, and perform simple~          actions.~        -  For 1 week, participants will wear a wrist device that measures daily activity.~   "
62910|NCT02233816|"~     A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled~     study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular~     injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to~     healthy adults 18-49 years of age.~      A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to~     receive one injection of either a low, a medium, or a high dose level of the quadrivalent~     VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150~     mM sodium chloride (NaCl) + 0.01% Tween 80).~   "
62941|NCT02233413|"~     The purpose of this research study is to find out if a specialized helmet that provides low~     levels of near infrared light, also known as low-level light therapy (LLLT) has any effect~     on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain~     injury (TBI).~   "
62911|NCT02233803|"~     This Phase IV study is an a multi-centre, randomised open label, two way cross-over design~     to evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with~     asthma. The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol~     Fumarate combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400)~     compared with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler.~      The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis~     of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40%~     to 85% of the predicted normal value, and are receiving a stable dose of inhaled~     corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic~     agonist (LABA) prior to screening.~      The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment~     Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1~     week). The total duration of the study for each subject will be at least 17 weeks. There~     will be up to 6 study visits and a follow-up telephone call.~      Pre-screening Visit will allow subjects who had recent asthma medication changes to be~     stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will~     receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and~     salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication.~     The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one~     inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week~     Washout Period between treatments).~      The study will include 300 subjects for screening so that at least 210 will be randomised~     and a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on~     Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment~     Period 2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B:~     BFF (320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout~     Period of 4 weeks.~      NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and~     TURBUHALER are trademarks of AstraZeneca~   "
62912|NCT02233790|"~     The patients with acute myocardial infarction (AMI) present high mortality and morbidity~     rate,even treated with stenting in the blocked heart vessels.~      The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow~     were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and~     spasm of the micro-vessel during stenting.~      An agent with more effective anti-clotting and micro-vessel dilation would be helpful to~     solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor~     and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous~     potent small vessel dilator.~      This study is to test the effectiveness of ticagrelor on improving reperfusion and~     minimizing the myocardial infarct size after PPCI in patients with AMI.~   "
62913|NCT02233777|"~     The present study was conducted to find out whether the bioavailability of 150 mg pregabalin~     capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule~     150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).~   "
62914|NCT02233764|"~     In this study, iron- and zinc-biofortified pearl millet will be fed to young children in~     Mumbai, Maharashtra, India over a period of nine months to measure growth, cognitive~     changes, and immune function in comparison to children receiving non-biofortified pearl~     millet.~   "
62915|NCT02233751|"~     Evaluation of pharmacokinetic and safety profile of testosterone after a single dose using~     auto-injector~   "
62916|NCT02233738|"~     Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are~     heavily represented in VA housing. VA recently adopted a 'Housing First' approach~     emphasizing rapid housing placement to initiate recovery without requiring sobriety and will~     necessitate SUD interventions that are efficient and easily layered onto existing services.~     The proposed study will investigate the effectiveness, implementation process, and cost~     estimate of Group Motivational Interviewing (GMI) for Veterans with SUDs in VA housing~     (Housing Urban Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]).~     Outcomes will be assessed at multiple time points using a multi-modal approach. The ultimate~     goal of this research is to establish the basis of a GMI dissemination and implementation~     course of action for highly vulnerable homeless Veterans in VA housing for achieving their~     greatest success in attaining housing stability.~   "
62917|NCT02233725|"~     Prostate cancer is the most common cancer in men. It is most often detected by an abnormal~     digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test.~     When it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy~     is performed by the Radiologist with ultrasound guidance through the rectum. In some~     patients, a Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further~     evaluate the prostate. In some situations, the MRI and Ultrasound images will be fused~     (digitally merged) together during the ultrasound procedure to help localize the~     questionable lesions. Recent research has used an additional component known as a contrast~     agent - an intravenously injected inert substance - which is identifiable by ultrasound.~     This inert substance is more obvious in areas of increased blood flow, which is a common~     finding in cancerous lesions. In this research project, we would like to determine whether~     the use of contrast-enhanced ultrasound is beneficial in improving accuracy of the biopsies~     taken and the relative correlation to the MRI/ Ultrasound-fused images.~   "
62918|NCT02233712|"~     An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center~     study in patients with Stage I-III gastric cancer. The first group of patients received a~     starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100~     µg or 500 µg was based on antibody response and dose tolerability.~   "
62919|NCT02233699|"~     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in~     reducing the daytime cough frequency in patients with chronic idiopathic cough.~      The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective~     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual~     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester~     Cough Questionnaire (LCQ) will be evaluated.~   "
62920|NCT02233686|"~     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in~     reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease~     (COPD).~      The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective~     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual~     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD~     Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory~     Questionnaire (SGRQ-C) will be evaluated.~   "
62952|NCT02233270|"~     When compared to existing analyses: manometry, Smart Pill and lactulose breath testing,~     external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique~     audible patterns characteristic of features of gastroinestinal (GI) motility, gastric and~     small bowel contractions and emptying and small intestinal bacterial overgrowth (SIBO). This~     research study is designed to test the capabilities of AbStats/AEGIS to identify and~     associate symptoms and traditional diagnostics with sound readings and correlate this data~     with treatment outcomes and successes in standard of care.~   "
62921|NCT02233673|"~     Excessive weight gain during pregnancy, particularly in overweight and obese women,~     predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal~     health. With an inverse relationship between socioeconomic status and obesity, significant~     health disparities exist between obese and normal weight women. The Institute of Medicine~     (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid~     body mass index (BMI), to minimize pregnancy complications. However, these recommendations~     are based on cross sectional observational studies and neither the ideal method to achieve~     weight gain goals nor whether perinatal outcome is optimized with active management of~     weight gain is known. The investigators propose to investigate a behavioral incentive-based~     intervention to improve compliance with IOM weight gain recommendations during pregnancy in~     low-income overweight and obese women. The investigators will evaluate if 1) gestational~     weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain~     management during pregnancy improves perinatal outcomes. Two study groups will be compared~     in a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those~     receiving behavioral weight management counseling plus financial incentives for achieving~     weight gain goals. The main outcome measure will be the percentage of women gaining within~     the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include~     fetal growth and body composition changes, birth weight and the rate of cesarean delivery.~     The investigators hypothesize that 1) the behavioral intervention with incentives will~     result in greater compliance to IOM guidelines for gestational weight gain than standard~     care and 2) targeting weight gain to the IOM guidelines will lead to a reduction in the~     rates of fetal macrosomia and cesarean delivery. Finally, cost effectiveness of treatment~     conditions will be examined. This intervention, if efficacious and cost-effective, has the~     potential to improve compliance with gestational weight gain guidelines, optimize perinatal~     outcomes, and reduce health disparities.~   "
62922|NCT02233660|"~     This randomized clinical trial will investigate changes in hand function, active cervical~     range of motion and pinch grip force after the application of physical therapy in women with~     carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,~     cervical range of motion and pinch grip force induced after the application of a physical~     therapy program including manual therapies targeted to those areas related to the median~     nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The~     hypothesis is that manual therapy is more effective for increasing cervical range of motion~     and pinch grip force, but similarly effective for improving function, than surgical~     treatment in women with CTS.~   "
62923|NCT02233647|"~     This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a~     pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will~     be conducted in which the subjective and physiological effects of cocaine are evaluated~     during maintenance on placebo and phendimetrazine.~   "
62924|NCT02233634|"~     Patients with an impaired blood supply of the heart routinely receive oxygen in order to~     improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent~     studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart~     was able to show that the administration of oxygen or fast breathing can decrease the blood~     supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of~     oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the~     investigators want to investigate, whether the administration of exogenous oxygen via a mask~     alone and in combination with fast breathing leads to a decrease in oxygen supply in regions~     with already impaired blood supply by a narrowing of a coronary artery of the heart.~   "
62925|NCT02233621|"~     Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One~     of the main problem of endometriosis is the significant delay of diagnosis.This delay has~     significant consequences for patients. Currently the definitive diagnosis of endometriosis~     and the evaluation of its lesional extension require performing laparoscopy and a~     histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose~     development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES~     (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission~     tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of~     this functional imaging as a diagnostic tool for endometriosis.~      The aim of this multicenter, prospective, open study is to assess sensitivity of PET with~     [18F] -FES for diagnosing endometriosis compared to the gold standard (histological~     confirmation on biopsy or excision of lesions performed during laparoscopy) in women care~     for suspected endometriosis and for whom laparoscopy is already scheduled.~   "
62926|NCT02233608|"~     Radical prostatectomy is a common and effective treatment for prostate cancer but is~     associated with urinary incontinence that can persist for several months after surgery and~     significantly reduce quality of life. Studies have shown that routine performance of pelvic~     floor exercises after radical prostatectomy can aid in the recovery of urinary control;~     however, conventional pelvic floor exercises do not produce consistent results. Research~     indicates that incorporating other deep abdominal muscles can further activate the pelvic~     floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'~     and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises~     with activation of supportive muscles. Our proposed study will be the first to test the~     effect of an advanced pelvic floor exercise training program that includes Pfilates and~     Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim~     of this study is to assess the feasibility of conducting a full-scale RCT of an advanced~     pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,~     and Hypopressives techniques on urinary incontinence. Feasibility will be determined by~     measuring recruitment success, retention, outcome capture, and intervention adherence,~     tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate~     cancer in the advance pelvic floor training program will report greater improvement in~     urinary incontinence and health-related quality of life.~   "
62927|NCT02233595|"~     The investigators will be using the combination of FDG-PET and multiparametric MRI in pre-~     and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response~     on surgical resection.~   "
62928|NCT02233582|"~     Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute~     mountain sickness such as headache and malaise. However, the blunting of inflammation by~     ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of~     inflammation for adjustments in breathing.~      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to~     altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue~     oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that~     subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours~     at altitude than will placebo subjects.~   "
62929|NCT02233569|"~     This is a monocenter randomized controlled trial comparing two systems of mesh and fixation~     device for the laparoscopic ventral and incisional hernia repair with respect to pain. It~     has been designed as a superiority study to proof the concept of previously published~     mathematical model of front abdominal wall.~   "
62930|NCT02233556|"~     Patients with schizophrenia are deeply affected by the positive symptoms, negative symptoms~     and cognitive impairment. A generalized cognitive deficit could be frequently observed and~     traced back to early stage of the disease. Currently medication intervention significantly~     improves positive symptoms through dopamine receptor modification, leaving alone the~     negative symptoms and cognitive impairment. Besides dopamine dysregulation, more and more~     attention had been paid to the association of N-methyl-D-aspartate (NMDA) type glutamate~     receptor and schizophrenia, focusing on the neurobiological and cognitive biomarkers change.~     Memantine, an uncompetitive antagonist of NMDA type glutamate receptor approved as cognitive~     enhancer for Alzheimer's disease, is a potential candidate for preventing cognitive decline~     of schizophrenia. Previous randomized clinical trials failed to demonstrate its efficacy on~     chronic schizophrenic patients and it might be related to the chronic and irreversible~     disease process. There is also study supporting that memantine induces change in mismatch~     negativity (MMN) in frontal cortex of healthy subjects. This study will compare the MMN~     change of healthy subjects and the population of early schizophrenia, who has persistent~     neurobiological, cognitive biomarkers or negative symptoms despite subsided positive~     symptoms. Both male and female aged 20-45 years old outpatients with a length of illness for~     less than 5 years since first diagnosed as schizophrenia, currently receiving treatment by~     atypical antipsychotics in a relatively stable condition will be recruited. Healthy subjects~     will be recruited comparing their age and sex. We plan to recruit 10 subjects for both~     patient and healthy subjects with a total of 20 participants. All participants will receive~     general clinical, cognitive and event-related potential (ERP) evaluation as baseline before~     taking medication. Twenty mg of memantine will be given 4 hours before ERP retest. The~     analyses will be performed based on the change of ERP using paired-t sample test. Baseline~     clinical and cognitive symptoms will be analyzed as possible confounders.~   "
62931|NCT02233543|"~     The purpose of this study is to determine whether a fixed dose combination of indacaterol~     and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic~     Obstructive Pulmonary Disease.~   "
62932|NCT02233530|"~     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger~     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.~      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to~     facilitate diagnosis of, and therapy for, people with dementia led by local communities in~     sub-Saharan Africa. The investigators seek to improve quality of life for people with~     dementia and their caregivers.~      Within this trial of CST, the investigators hypothesise that CST can significantly improve~     the quality of people with dementia and their carers living in Africa~   "
62933|NCT02233517|"~     Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S.~     Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among~     their top priorities. PTSD-related anger and aggression are associated with profound~     functional impairments, yet to date there are no empirically-supported treatments for~     Veterans with PTSD and aggression. Effective group treatment programs could improve~     functioning and facilitate community reintegration for these Veterans. Given that anger~     impedes progress in treatment of PTSD symptoms, group anger treatment could also improve~     Veterans' capacity to benefit from individually-administered empirically-supported therapy~     for PTSD such as prolonged exposure or cognitive processing therapy.~   "
62934|NCT02233504|"~     The purpose of this trial is to examine the hematologic response rate of Exjade® in patients~     with AML and high risk MDS and chronic iron overload from blood transfusions. Deferasirox~     has been developed as an iron-chelating agent, and unlike deferoxamine, a previously~     developed iron chelator, deferasirox has the advantage of oral administration.~   "
62935|NCT02233491|"~     Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney~     transplantation, related to both transplant-specific and generic risk factors, and is~     associated with major complications after transplantation. The current PTDM Consensus Report~     recommends lifestyle modification (e.g. weight loss, dietary modification, structured~     exercise program) as the first line therapy of choice. No recommendation is given with~     regards to how such guidance should be delivered. In addition no clinical evidence exists to~     suggest lifestyle modification provides any sustained glycaemic benefits for kidney~     allograft recipients.~      While in the general population the benefits of lifestyle modification have been well~     documented with regards to attenuation of both pre-diabetic and diabetic states in the~     context of randomised controlled trials, no similar level of evidence exists post kidney~     transplantation.~      This prospective randomised controlled trial is designed to compare active versus passive~     lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic~     risk profile over the course of the intervention.~   "
62936|NCT02233478|"~     This study is comparing the quantity of active metabolites from consuming pomegranate juice~     in three different preparations. People who participate in this study will come in to the~     Center for a screening visit, which includes a blood test and medical history. If you~     qualify based on the screening visit, you will then come in to the Center while fasting in~     the morning on three different days. You will eat a standardized breakfast and drink one of~     three juices, and then remain for metabolic testing at the Center for a period of time after~     eating. You will also be provided a standardized lunch and water during this period. Each of~     those visits will last about 7 hours. During this time, and for the rest of the 24 hours~     following drinking the juice, you will collect all of your urine. Following all three of~     these 7-hour visits, you will return to the Center again the next day for a fasting blood~     draw, drop off your urine sample, and pick up a new container to collect another 24 hour~     urine sample. The following day, you will return to the Center to drop off your second urine~     sample collection.~   "
62937|NCT02233465|"~     Parastomal herniation is difficult to treat. Several different treatment has been tested but~     still none has revealed to be superior. The use of a mesh has been shown to be a promising~     way of treating. In this study the investigators will evaluate safety and hernia recurrence~     rate with a mesh tailored to treat parastomal hernias Parastomal hernia mesh BARD in~     patients with parastomal hernia requiring surgery.~   "
62938|NCT02233452|"~     Methadone and ketamine are effective for neuropathic pain management. However, the benefits~     of the association of both drugs are uncertain. Here, the investigators conducted a~     randomized, double-blind, in parallel, active controlled clinical trial to test the~     hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than~     methadone or ketamine alone in reducing neuropathic pain.~   "
62939|NCT02233439|"~     The purpose of this study is to assess the effectiveness of a commercially available product~     containing a combination of Silybum marianum and Galega officinalis to support continuation~     or augmentation of breast milk production.~   "
62940|NCT02233426|"~     The purpose of this study is to assess the effectivity of using hypertonic nasal solutions~     alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients,~     retrospectively.~   "
62942|NCT02233400|"~     Bariatric surgery is the only proven and effective long term treatment for morbid obesity.~     In an attempt to reduce patients' post-operative hospital stay, lower associated health care~     costs, and improve satisfaction scores, St Luke's University Health Network (SLUHN) recently~     adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is~     safe and effective when performed in a Center of Excellence (COE) such as ours. However,~     post-operative pain control remains a challenging issue, with only intravenous (IV) or PO~     (by mouth) narcotics appropriate for bariatric surgery patients.~      IV acetaminophen, which has been used successfully in Europe, was recently approved by the~     Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the~     use of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its~     cost effectiveness. Therefore, our study will investigate the economic impact of~     administering IV acetaminophen to bariatric surgery patients, as well as its effect on~     clinical outcomes such as patients' post-operative length of stay, self-reported pain,~     readmissions, emergency room (ER) visits and complications.~      The study design will be a randomized, double-blind, parallel-group, controlled trial in a~     single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health~     Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery~     candidates > 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB)~     or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen~     plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the~     remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for~     the first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data~     analysis will include quantile regression, mixed randomized-repeated analysis of covariance~     (ANCOVA) and selected univariate comparisons, with p < .05 denoting statistical significance~     for all outcomes.~   "
62943|NCT02233387|"~     The aim of this study is:~        1. to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in~          cervix cancer,~        2. to correlate the [18F]HX4 PET images with blood and tissue markers,~        3. to investigate the quality and optimal timing of [18F]HX4 PET images,~        4. to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and~        5. analyze correlation with responses~   "
62944|NCT02233374|"~     The purpose of this study is to investigate if PET/CT and MRI scans performed early in~     treatment and six weeks after treatment can predict the response of rectal cancer following~     chemotherapy and radiotherapy. This will help doctors to better tailor treatments for rectal~     cancer in the future.~   "
62945|NCT02233361|"~     The proportion of elderly people is expected to increase greatly within the next couple of~     decades, resulting in a proportional increase in the need for hearing rehabilitation.~     However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus,~     a major challenge for audiological rehabilitation is facilitating the use of fitted hearing~     aids.~      This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up~     appointment on hearing aid use, 2) to implement a specialized counselling program based on~     MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use~     with datalogging technology.~   "
62946|NCT02233348|"~     Autism spectrum disorders (ASD) is a common childhood-onset, multi-factorial, highly~     heritable, clinically and genetically heterogeneous, neurodevelopmental disorder. Due to its~     high prevalence and severe lifelong impairment without effective prevention and treatment,~     there is a dearth of investigating its pathogenesis, longitudinal outcome, and biomarkers~     (endophenotypes). The ultimate goals of this 5-year project are to prospectively investigate~     the outcome and changes of psychosocial and neurocognitive functions of a cohort of probands~     with ASD at adolescence and young adulthood as the primary aim; and to test whether~     structural and functional brain connectivity can be effective endophenotypes of ASD using~     the unaffected sibling and follow-up designs as the secondary aims.~   "
62947|NCT02233335|"~     Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may~     arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they~     are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome~     results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it~     is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease~     has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH).~     ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated~     Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%.~     The first line treatment is tumor resection. Other managements include radiotherapy,~     medication and bilateral adrenalectomy. The initial remission rate is high (66-90%).~     However, some patients encounter with disease recurrence during follow-up.~      The aim of this study is to clarify the factors associated with the recurrence after~     treatment. In this study, we will review the patients with Cushing disease thoroughly and~     analyze associated predisposing factors. These risk factors can remind the clinical~     physician to early detect the recurrent disease in these patients, and further prevent~     morbidity and mortality in their later lives.~   "
62948|NCT02233322|"~     The purpose of the study is to gain a better understanding of the effect of iron on~     fibroblast growth factor 23 (FGF23) in the inherited disorder, autosomal dominant~     hypophosphatemic rickets (ADHR). ADHR is an inherited disorder in which the body makes too~     much FGF 23 and causes low blood phosphorus levels and bone problems such as rickets (bowed~     legs in children) or bone pain and weakness in adults. This study is to test whether or not~     giving iron helps correct the high FGF23 and there by correcting the phosphate problem.~   "
62949|NCT02233309|"~     This study is a prospective study of epidural pressure changes when local anesthetic is~     injected from the caudal route. All patients will receive the same weight based volume dose~     of local anesthetic after induction of general anesthesia, and a CVP transducer will be~     attached to the standard caudal needle for measurement of pressure: under the skin, after~     entering the epidural space, and every 15 seconds for 3 minutes after completion of~     injection with the needle in situ. The placement of the caudal epidural will follow current~     standard of care and administration, the only variation will be the addition of a pressure~     transducer to the stopcock where the local anesthetic syringe is attached that will allow~     for pressure monitoring.~   "
62950|NCT02233296|"~     This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of~     lasmiditan in healthy subjects.~   "
62951|NCT02233283|"~     Undernutrition has a known and well recognized negative impact on reproductive hormones, and~     ultimately fertility. In contrast, much less is known regarding the potential effects of~     overnutrition on the same hormones. Epidemiological data suggest that overnutrition might~     have a deleterious impact as well on the fertile potential of affected women, but very~     little is known about the mechanisms implicated. Such knowledge may be of importance, given~     the increasing prevalence of overweight and obesity worldwide.~   "
62953|NCT02233257|"~     X-linked adrenoleukodystrophy (ALD) is a genetic disorder affecting the brain and adrenal~     glands. Approximately one third of boys who are at risk will develop cerebral disease. Using~     a specific diet and the compound Lorenzo's oil, it can be shown that very long chain fatty~     acids may be lowered in the blood, but it is not known to what degree that may prevent the~     onset of childhood disease.~      This proposal makes available Lorenzo's oil to individuals with ALD, a life threatening~     disorder for which there are presently no other therapies.~   "
62954|NCT02233244|"~     This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A~     activity in healthy subjects.~      The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood~     levels will not change after treatment with CTX-4430.~   "
62955|NCT02233231|"~     This is a study describing changes in inflammation of the airways in asthmatics before and~     after smoking cessation and steroid treatment.~   "
62956|NCT02233218|"~     To investigate the pharmacokinetic Drug-drug interaction~   "
62957|NCT02233205|"~     Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the~     therapeutic effects. The main purpose is to identify the safety of combining ultrasonic~     microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from~     alimentary system and pancreatic carcinoma.~   "
62958|NCT02233192|"~     The purpose of this study is to observe patient response to current clinical practice~     utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure~     Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S.~     cities that are currently offering this method as standard of care. This study is an~     observational cohort study, which will test the feasibility and acceptability of PrEP for~     conception, while examining the challenges and generalizability of this current medical~     practice. The CDC recently released formal clinical practice guidelines for the use of PrEP~     in the United States. For high-risk serodiscordant heterosexual couples using PrEP during~     conception, the guidelines state, PrEP use periconception and during pregnancy by the~     uninfected partner may offer an additional tool to reduce the risk of sexual HIV~     acquisition. Both the FDA labeling information and the perinatal antiretroviral treatment~     guidelines permit this use (CDC 2014).~   "
62959|NCT02233179|"~     The aim of the study was to explore the association between activities of daily living (~     measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an~     exploratory study, there was no study hypothesis.~   "
62960|NCT02233166|"~     In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first~     choice of treatment. Studies in recent years have shown that the procedure does not always~     have the expected effect. Children with OSA are at greater risk for complications from the~     procedure.~      There is disagreement regarding the need for sleep studies in children prior to surgery in~     order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography~     (PSG).~      The main purpose of this study is to describe the prevalence of OSA among children referred~     for adenotonsillectomy.~      The investigators will also examine these children prior to and six months after surgery to~     assess their sleep pattern and quality of life.~      The project outcome aims to improve the precision and quality of diagnosis and the short and~     long term effects of treatment of children with OSA.~   "
62961|NCT02233153|"~     The aim of this study is to examine the impact implementing an elder-friendly surgical unit~     has on post-operative complications, mortality and quality of life for patients ≥ 65 years~     old who have undergone emergency surgical care.~   "
62962|NCT02233140|"~     Diabetic foot complications are a common and costly problem. Excessive plantar pressures due~     to foot deformities and/or limited ankle dorsiflexion, especially in the presence of~     peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers.~     Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic~     foot ulcers.~      Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation~     Technology) was effective in treating subjects with chronic heel pain and Achilles~     tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with~     ankle equinus to perform more effective stretching exercises and may prevent recurrence of~     diabetic foot ulcers.~      The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus~     manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk~     subjects with a history of diabetic foot ulcer.~   "
62963|NCT02233127|"~     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of~     only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding~     of the causes of child mortality is necessary to guide research efforts aimed at tackling~     this important global health problem. Prospective birth cohort studies present an~     opportunity to examine the relationships between early-life exposures and multiple health~     and non-health related outcomes including death, illness, and socioeconomic factors. In this~     study, we will provide insight into the underlying causes of child mortality by collecting~     high-quality data on early-life exposures and health and non-health related outcomes in the~     first year of life.~   "
62964|NCT02233114|"~     Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and~     quality of life in patients with obstructive lung diseases. With follow up after 6 months.~   "
62965|NCT02233101|"~     Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the~     different routes of drug administration are equivalent in terms of post-operative reduction~     in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.~      Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.~   "
62985|NCT02232841|"~     The goal of this study is to evaluate the sensitivity and specificity of Electrical~     Impedance Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who~     are mechanically ventilated. In electrical impedance tomography low amplitude, low frequency~     current is applied on electrodes, and the resulting voltage is measured and used to computed~     the electrical properties of the interior of the chest as they change in time. The computed~     properties are used to form an image, which can then be used for monitoring and diagnosis.~   "
63126|NCT02230995|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing empagliflozin and metformin extended release compared to~     the free combination of empagliflozin and metformin extended release under fed conditions.~   "
62966|NCT02233088|"~     Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS),~     diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride~     and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and~     doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle~     modification is the initial step of treatment, but few studies have demonstrated early and~     sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change~     program for patients with MetS included a 1-year of development of an intervention by an~     interdisciplinary team of experts in medicine and the behavioral sciences. The investigators~     then tested the efficacy of the intervention in a treatment-only, proof-of-concept study.~     The investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26~     patients. This study is the second step of a research program testing an innovative~     bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by~     focusing on eating patterns, daily activity, and stress management. The overarching~     objective of this research program is to determine the efficacy of the ELM lifestyle~     intervention to achieve remission of MetS. This purpose of the current study is to prepare~     for a large, randomized, clinical trial by conducting a smaller clinical trial that examines~     the acceptability of the ELM intervention (ELM Group) as compared to two other intervention~     arms (ELM Classes, ELM Individual).~   "
62967|NCT02233075|"~     REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to~     clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV~     infected ducks) and in human patients and to act synergistically with immunotherapeutic~     agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host~     immunological control of HBV infection.~      HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action~     of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated~     interferon-alpha 2a is expected to have a significant antiviral effect against HDV~     infection.~      This study will examine the safety and efficacy of REP 2139-Ca therapy when used in~     combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.~      The primary hypothesis to be tested is that this combined dosing regimen is safe and well~     tolerated in patients with HBV / HDV co-infection which will be assessed by examining the~     number of patients with adverse events (including reported symptoms and laboratory~     abnormalities).~      The secondary hypothesis to be tested is that this combined dosing regimen will have an~     antiviral effect against HBV / HDV co-infection in these patients which will be assessed by~     examining the following outcomes:~        1. The number of patients with reductions in serum HBsAg.~        2. The number of patients with reductions in serum HDAg and HDV RNA~        3. The number of patients that experience a sustained antiviral response after treatment~          is stopped (reductions in serum HBV DNA and HDV RNA).~      The secondary hypothesis to be tested is that this combination approach can have an~     effective~   "
62968|NCT02233062|"~     The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm~     quality of patients with crohn's disease.~   "
62969|NCT02233049|"~     Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and~     adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the~     most common malignant brain tumours, there are only 30 to 40 new cases per year in France.~     Their clinical presentation is stereotyped with a short clinical history and a unique MRI~     appearance that was usually considered as sufficient to establish the diagnosis. The~     prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in~     general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave~     2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of~     paediatric oncology; despite numerous collaborative studies performed, patients' survival~     has not significantly increased in thirty years (Hargrave 2009). There is no validated~     prognostic factor. There is currently no validated treatment except radiotherapy.~      Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger,~     2011), without knowing whether the target was present in the tumour. A critical review of~     the paradigms of these trials tells us that there are long term survivors in these studies~     that is to say patients who may have benefited from the tested therapy, but they are few. So~     far, the new therapies that have been tried were evaluated one after the other in search of~     a treatment that would be effective for all patients, measuring the treatment effect on~     median survival. They were all rejected as ineffective. However the investigators can~     challenge the endpoint to evaluate efficacy in these trials as the existence of long term~     survivors (> 18 months, for example) and their number should not been ignored, especially if~     targeted therapies are considered. The investigators propose a paradigm shift in the choice~     of treatment; the issue raised would be to give to each patient the treatment associated~     with the highest likelihood of efficacy based on the specific biological tumour profile.~      The development of targeted therapies for malignant gliomas infiltrating the brainstem has~     been hampered by the absence of biological data. It is therefore crucial to better~     understand the biology of these tumours. Despite the safety of the biopsy in brainstem~     tumours, most teams of paediatric neurosurgery limit the use of stereotactic biopsy only for~     clinically or radiologically unusual forms. Until recently, there has been no systematic~     genetic study at diagnosis to date and the few available data were confounded by the~     inclusion of autopsies or clinically and radiologically unusual cases (Louis, 1993;~     Gilbertson 2003; Okada, 2008; Zarghooni 2010; Broniscer, 2010; Wu, 2012 and~     Schwartzentruber, 2012).~      French teams gathered in the French Society of Paediatric Oncology and the European~     consortium Innovative Therapies in Children with Cancer (ITCC) decided a few years ago to~     perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of~     certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted~     therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team~     of the Necker Hospital in Paris, confirming the low rate of complications of stereotactic~     biopsy procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing~     immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct~     sequencing of candidate genes studies.~      In this study, the majority of patients will receive a treatment assumed to specifically~     target a biological abnormality identified on the biopsy. More importantly, patients will~     not receive a drug for which the identified target is absent.~      In this first step of the protocol, the patients will thus be allocated to one of the three~     treatment groups as follows:~        -  If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive~          erlotinib or dasatinib allocated by randomization (R1 randomisation).~        -  If the tumor shows loss of PTEN expression without EGFR overexpression, patients may~          receive everolimus or dasatinib allocated by randomisation (R2 randomisation).~        -  If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may~          receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).~        -  If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare~          situation in our experience), patients will receive dasatinib (no randomisation).~        -  If the biopsy assessment is not contributive, the treatment will be allocated by~          randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).~   "
62970|NCT02233036|"~     Background:~      People who get chronic illnesses as children are living longer. When they turn 18, they~     switch from pediatric care to adult care. This can be a difficult change. Chronic~     Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated~     infections. People with CGD are usually diagnosed when they are very young children.~     Researchers want to find out more about how young people with CGD handle the change to adult~     care. What they learn may make this easier for people with CGD in the future.~      Objective:~      - To identify what helped or hurt young adults with CGD as they went from pediatric to adult~     care.~      Eligibility:~      - Adults with CGD who were 18 24 years old between January 2011 and February 2014.~      Design:~        -  Participants will already be enrolled in NIH studies.~        -  Eligible people will get materials in the mail. They will get a letter with study~          information, an interview questionnaire, and an information sheet.~        -  Researchers will call participants 1 week after the packets are sent. They will talk~          about the study and find out if the person wants to join.~        -  An interview will be completed immediately or scheduled for the future. The interview~          will take about 45 minutes. The researcher will ask the participant about their~          disease. They will also ask about travel to NIH, being an outpatient or inpatient~          there, and legal documents.~        -  Researchers may contact the subjects again by phone if they need more information at~          any point during the study.~   "
62971|NCT02233023|"~     Study to assess and compare the safety of long term oral treatment for Parkinson's Disease~     with pramipexole versus bromocriptine or other dopamine agonists, by measuring~     cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal~     degeneration, in a matched pair design~   "
62972|NCT02233010|"~     Although post-op renal function decrease is determined by serum creatinine, serum creatinine~     has disadvantages that it increases a long time after renal function decrease and it has~     various increasing time based on the level of renal function. Neutrophil~     Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage~     occurring from post-op cardiac surgery, being critical patients and contrast medium use is~     already proven.~      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and~     especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal~     disease patients is not proven.Therefore, the investigators will study about renal function~     decrease after non-cardiac surgery with NGAL and serum creatinine.~   "
62973|NCT02232997|"~     No well-defined protocols exist to guide fluid administration for prevention of contrast~     induced nephropathy in high risk patients. The investigators will compare long term~     hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term~     hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our~     hypothesis that the short term hydration may not be inferior to the long one.~   "
62974|NCT02232984|"~     The purpose of the study is to evaluate different ways to program around extracardiac~     stimulation.~   "
63009|NCT02232529|"~     The aim of the study is to assess how MIN-101 is taken up by the body when given in~     different amounts and in different formulations. The drug will be given as a single dose in~     Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days.~     The ultimate aim is to find an optimal formulation which can be developed as a once daily~     dose for the treatment of schizophrenia.~   "
62975|NCT02232971|"~     Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin~     and are advised to aim for near-normalization of blood glucose levels through intensive~     insulin therapy. We propose a new approach for achieving treatment goals in T1D: the~     combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect~     of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon~     treatment of mild hypoglycemia are needed to determine whether there is clinical rationale~     for dual-hormone treatment of T1D.~      Aim: The purpose of this clinical study is to investigate the glycemic response to~     subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with~     insulin pump. Different glucagon doses are applied to determine the most appropriate dose~     for future dual-hormone treatment of T1D.~      Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight~     T1D patients treated with insulin pump are studied on four days. All patients are in good~     metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On~     each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated~     with a single subcutaneous dose of glucagon. The study procedures are identical on all days~     except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug,~     day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days~     in random order.~      Endpoints: The present study focuses primarily on the dose related plasma glucose response~     of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary~     the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and~     triglycerides.~      The study will be conducted from august 2014.~   "
62976|NCT02232958|"~     The purpose of this study is to extend our previous work, in which we demonstrated an~     increase in the internal and cross network connectivity of resting state neural networks in~     patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least~     20 more individuals.~   "
62977|NCT02232945|"~     This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen~     granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.~   "
62978|NCT02232932|"~     A prospective, open-label, randomised, multicentre, comparative study in two parallel groups~     comparing an interventional group with liver transplantation preceded by neoadjuvant~     radio-chemotherapy and a control group receiving conventional liver and bile duct resection.~      The primary endpoint will be overall survival at 5 years in the intent-to-treat population.~     The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and~     tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the~     intent-to-treat population.~      The number of subjects necessary is 54 patients (27 x 2): this population will enable the~     demonstration of a significant difference is 5-year survival rates between the transplanted~     group and the resected group with a power of 80% and a first-species risk of 5%, under the~     hypothesis that these survival rates are 70% in the transplanted group and 30% in the~     resected group.~   "
62979|NCT02232919|"~     The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well~     as the psychological effects and related health-care costs, are well established in the~     medical literature. Lifestyle and dietary patterns remain critical factors modulating~     long-term weight control of morbidly obese individuals (bodymass index ≥ 40). Various~     dietary, pharmacological, and behavioral interventions have largely failed as therapies,~     often necessitating surgery as the last treatment option. Long term results of bariatric~     surgery suggest that sustained and substantial weight loss can decrease morbidity related to~     obesity secondary complications such as diabetes type 2 and cancers, enhancing the role of~     surgery for morbidly obese subjects. However the adverse effects of bariatric surgery are~     considerable and impact on quality of life. Its long-term failure rates and complications~     call for novel and effective long-term therapies, such as neurosurgical interventions.~      The investigators now propose to enhance our targeting capabilities in a feasibility study~     of low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six~     morbidly obese patients. After successful targeting, DBS stimulation parameters will be~     systematically evaluated and individually optimized at three-month intervals over a one-year~     stimulation period. Detailed recording of side effects, weight changes, food intake~     patterns, metabolic changes, and behavioral evaluations will be obtained throughout the~     study.~   "
62980|NCT02232906|"~     Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can~     reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels~     and iron status in adult patients with non-dialysis-dependent CKD who were on a stable~     ESA/oral iron schedule for 6 months prior to enrolment.~   "
62981|NCT02232893|"~     TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian~     ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous~     decoction and granulation technology. The aim of this study is to assess the effect of~     TU-100 on abdominal discomfort during the 4 week postoperative period after straight,~     hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for~     subsequent outcome studies also will be explored.~   "
62982|NCT02232880|"~     The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug~     Administration to treat rheumatoid arthritis, may help blood pressure medications to work~     better. This will be studied in people with high blood pressure that is not well controlled~     on three or more blood pressure medications, the condition also known as resistant~     hypertension. We expect to show that adding abatacept therapy to standardized treatment of~     resistant hypertension will result in a greater decrease in blood pressure at 24 weeks~     compared to treatment with placebo and conventional blood pressure treatment.~   "
62983|NCT02232867|"~     It has been found that arm and leg cycling is similar to walking in terms of the muscle~     activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking~     activate similar neural pathways. Another advantage of arm and leg cycling is that it~     involves coordination of all four limbs in a rhythmic movement. This may be particularly~     beneficial given previous findings that arm movement contributes to the activation of leg~     muscles during walking in humans. This is achieved with interconnected neural pathways that~     link the arms to the legs. These neural interlimb connections remain intact in stroke~     victims, such that maximizing the contribution of the arms to the legs may increase~     coordination for walking. Thus, the objectives of this research are to determine if arm and~     leg cycling can be used to increase the strength of interlimb connections and if this helps~     to improve walking ability in a post-stroke population. It is hypothesized that arm and leg~     cycling will transfer to improvements in walking in a post stroke population.~   "
62984|NCT02232854|"~     According to the literature the management of depressive disorders at primary care level is~     not always consistent with guidelines. The main objective of this study is to test whether a~     Comprehensive Technology-Assisted Training and Supervision Program will improve depression~     management in Primary Health Care clinics in Santiago, Chile.~   "
62986|NCT02232828|"~     Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step~     incomplete excavation seems advantageous compared with complete caries removal. However,~     current evidence regarding the success, as defined by not requiring any re-treatments, or~     survival of teeth after different excavations is insufficient for definitive recommendation,~     especially when treating deciduous teeth. Moreover, restoration integrity has not been~     comparatively analyzed longitudinally, and neither patients', dentists' or parents'~     preferences nor the clinical long-term costs emanating from both initial and re-treatments~     have been reported yet.~      Our primary hypothesis is that success rates differ significantly between selectively and~     stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to~     significantly differ between selectively and stepwise excavated teeth.~   "
62987|NCT02232815|"~     This study will examine outcomes for patients treated by planned culotte stenting and~     compare outcomes with 2 different stent platforms, the next generation Synergy II and the~     Xience Xpedition DES platforms.~   "
62988|NCT02232802|"~     This will be an open-label, randomised, single-dose, 2-way crossover study to determine the~     comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80~     mg/0.8mL) with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single~     dose administration in healthy male and female subjects.~   "
62989|NCT02232789|"~     The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of~     mephedrone after oral administration and 2) to compare the pharmacological effects of~     mephedrone with those obtained after administration of oral~     3,4-methylenedioxymethamphetamine (MDMA, ecstasy).~   "
62990|NCT02232776|"~     The investigators hypothesize that using Losartan would help decrease proteinuria in~     controlling proteinuria in children with immunoglobulin A nephropathy.~   "
62991|NCT02232763|"~     The investigators hypothesize that using Losartan would help decrease proteinuria in~     pediatric chronic kidney disease with tubular proteinuria.~   "
62992|NCT02232750|"~     The investigators hypothesize that CPD parameters will provide improved prediction of sepsis~     compared to currently employed laboratory parameters. These studies hold the potential to~     shape practitioner guidelines and improve the timeliness and accuracy with which patients~     with sepsis are treated today.~   "
62993|NCT02232737|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     people with affective disorders. People with affective disorders are at an increased risk~     for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at~     significantly increased risk for smoking-related adverse health consequences. Studies~     testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to~     a non-addictive level have shown promising beneficial effects (decreased smoking rate,~     reduced toxicant exposure, and increased cessation) in the general population of smokers.~     However, these studies have uniformly excluded vulnerable populations like people with~     current affective disorders, who may respond differently considering their greater~     vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about~     how this highly vulnerable subgroup of smokers may respond to a nicotine reduction policy.~     This project is designed to fill that substantial knowledge gap.~   "
62994|NCT02232724|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current~     methods for staging of bone metastases are known to be inaccurate. Staging of lymph nodes~     requires surgery associated with risk of bleeding etc. Prior studies from our department~     suggest that PET/CT is useful in staging of bone metastases in patients with prostate~     cancer. The aim of this study is to compare the usefulness of Dual time point FDG PET/CT~     with current methods for the staging of bone and lymph node metastases in patients with~     newly diagnosed prostate cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate and non-invasive method of staging patients with undetected~     metastases on current staging will be spared of the side-effects associated with current~     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.~   "
62995|NCT02232711|"~     The purpose of this study is to assess the accuracy and ease-of-use of a simplified~     FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the~     manufacturer's instructions by personnel in laboratories holding Clinical Laboratory~     Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples~     obtained from volunteers with signs and/or symptoms of a respiratory infection. The study~     data will be used to support an application to the FDA for CLIA-waived categorization of~     FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed~     in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing~     performed in a lab with a moderate or high complexity CLIA certification.~   "
62996|NCT02232698|"~     The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose~     Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing~     using a randomised controlled study design in adults with Type 1 diabetes using insulin.~   "
62997|NCT02232685|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current~     methods for staging are known to be inaccurate. Prior studies from our department suggest~     that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The~     aim of this study is to test the usefulness of Choline PET/CT for the staging of bone~     metastases compared to current standard methods in patients with newly diagnosed prostate~     cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate method of staging patients with undetected metastases on~     current staging will be spared of the side-effects associated with current treatment -~     impotence, incontinence, radiation damage etc.~   "
63020|NCT02232386|"~     The present study aims at evaluating whether treatment with two different drugs, Ibrutinib~     and Rituximab is both efficient and safe for newly diagnosed patients with chronic~     lymphocytic leukemia.~   "
63127|NCT02230982|"~     To provide early access and to evaluate the safety and tolerability of nintedanib in~     patients with idiopathic pulmonary fibrosis (IPF)~   "
62998|NCT02232672|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current~     methods for staging of bone metastases are known to be inaccurate. Staging of lymph nodes~     requires surgery associated with risk of bleeding etc. Prior studies from our department~     suggest that PET/CT is useful in staging of bone metastases in patients with prostate~     cancer. The aim of this study is to compare the usefulness of MeAIB PET/CT with current~     methods for the staging of bone and lymph node metastases in patients with newly diagnosed~     prostate cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate and non-invasive method of staging patients with undetected~     metastases on current staging will be spared of the side-effects associated with current~     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.~   "
62999|NCT02232659|"~     The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and~     Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent~     (about to happen) death from irreversible biventricular heart failure.~      The purpose of this research study is to evaluate whether the TAH-t can support patients~     with life-threatening irreversible biventricular heart failure who are not eligible for~     transplantation. The TAH-t, when used for patients who are not eligible for transplant, is~     considered to be an investigational (not approved by FDA) use. This use is called~     destination therapy (DT).~      Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for~     cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to~     six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that~     are experienced by the enrolled subjects and comparing them to previous experience of TAH-t~     patients who were waiting for a heart transplant. Since approximately 74% of patients with~     this condition would not be expected to live beyond six months, the benefit of the TAH-t for~     DT will be confirmed based on survival to six months without experiencing permanent~     disabling stroke-related deficits. After the six month follow-up visit, patients will~     continue to be followed under the study for up to five (5) years postTAH-t implant [every~     six months for up to two years while supported with the TAH-t implant and then annually for~     another three years].~      Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further~     characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be~     the same for patients enrolled in both arms of the study.~   "
63000|NCT02232646|"~     This is an open label, multi-center, Phase II study of BBI503 administered to adult patients~     with selected advanced urologic malignancies. The primary objective of this study is to~     evaluate the disease control rate of patients with renal cell cancer and urothelial~     carcinoma treated with BBI503.~   "
63001|NCT02232633|"~     This is an open label, multi-center, phase II study of BBI503 administered to adult patients~     with advanced hepatobiliary cancer who have exhausted all currently approved standard~     anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous~     28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no~     longer clinically benefiting from therapy.~      Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study~     treatment.~   "
63002|NCT02232620|"~     This is an open label, multi-center, phase II study of BBI503 administered to adult patients~     with advanced gastrointestinal stromal tumor who have exhausted all currently approved~     standard anti-cancer treatment options. BBI503 will be administered orally, daily, in~     continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until~     patients are no longer clinically benefiting from therapy due to disease progression,~     adverse events, or another discontinuation criterion.~      Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study~     treatment.~   "
63003|NCT02232607|"~     The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg~     decreased the symptoms of angina, compared to placebo in patients with chronic stable angina~   "
63004|NCT02232594|"~     The aim of this postmarketing surveillance is to obtain further information about the~     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic~     obstructive respiratory tract disease under conditions of daily practice~   "
63005|NCT02232581|"~     The primary objective was to determine the mean change in HIV viral load from baseline to~     Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected~     patients.~      Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety~     of different doses of alovudine and (2) the effect of baseline nucleoside genotypic~     susceptibility on virologic response after 4 weeks of alovudine administration~   "
63006|NCT02232568|"~     Trial of Feedback on Blood Use (TOFU)~      The TOFU study will represent the first attempt to rigorously assess the impact of~     audit-feedback on changing transfusion practice. The primary hypothesis is that providing~     individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC~     transfusions in the postoperative period.~      TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data~     will be collected at all study sites. Next, the PI at each site will give a short~     educational presentation to the orthopedic surgeons. The presentation will consist of a~     standardized 10-minute presentation reviewing the data from the FOCUS trial and the~     recommended red blood cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based~     on that data. Clusters of orthopedic surgeons will then be randomized to either the Control~     arm (no feedback) or the Intervention arm (monthly feedback). All of the surgeons at a given~     site will either receive or not receive feedback. The feedback will take the form of emailed~     monthly reports detailing blood use by each surgeon post-hip surgery. Surgeons will be~     anonymized in the reports as A, B, C . . . but each surgeon will know which data are his~     own. The primary end point is the decrease from baseline in the proportion of patients~     transfused with a pretransfusion hemoglobin of > 8 g/dL.~      TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken~     to minimize the labor and costs required to conduct this study. The only data collected will~     be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC~     units transfused; Hgb levels. The data will be entered at each site into a web-based Case~     Report Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC~     will generate monthly feedback reports and email them to each Intervention arm site PI. The~     site PI will then email the reports to each local orthopedic surgeon.~   "
63007|NCT02232555|"~     The purpose of this study was to investigate the efficacy of duloxetine versus placebo on~     pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory~     Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment~   "
63008|NCT02232542|"~     Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of~     duloxetine BID or placebo for 7 days~   "
63149|NCT02230696|"~     To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA~     approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.~   "
63010|NCT02232516|"~     The purpose of this study is to evaluate how safe and effective the combination of the study~     drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma~     (PTCL) who have not been previously treated for this cancer. Currently, there is no standard~     treatment for patients with PTCL; the most common treatment used is a combination of drugs~     called CHOP, but this can be a difficult treatment to tolerate because of side effects, and~     is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type~     of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways~     that can stop tumors from growing. It is given as an infusion through the veins.~     Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for~     short. This drug affects how tumor cells grow and survive, including affecting blood vessel~     growth in tumors. It is given as an oral tablet (by mouth).~   "
63011|NCT02232503|"~     The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy~     in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements~     in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of~     diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration~     of diabetes mellitus and risk factors. Project will also identify genetic factors linked~     with the diseases.~   "
63012|NCT02232490|"~     Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the~     therapeutic benefit of hepcortespenlisimu (V5) in subjects with advanced hepatocellular~     carcinoma. The results will be compared to placebo. The trial duration is 3 months and will~     consist of one stage with baseline laboratory evaluation including AFP levels with follow-up~     at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be~     preformed. The clinical evaluation will be quantified according to special performance~     questionnaire.~   "
63013|NCT02232477|"~     This is a five-year extension study of the pilot study, Intrathecal Enzyme Replacement for~     Cognitive Decline in MPS I. Participants must have completed the pilot study to participate~     in this study.~   "
63014|NCT02232464|"~     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset~     neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive~     deficits may last to adulthood. Our previous studies, like western results, have shown that~     children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways~     and impaired brain activity in frontoparietal network. However, there is lack of data with~     regards to whether adults with ADHD also demonstrate structural and functional~     disconnectivity of frontostriatal and frontoparietal networks as compared to healthy~     controls without ADHD in Asian population and no study has been done to correlate a wide~     range of executive functions with the connectivity of these two networks.~      Specific Aims:~        1. to compare the executive functions, and structural and functional connectivity in~          frontostriatal and frontoparietal circuitries between adults with ADHD and healthy~          controls without ADHD;~        2. to correlate the data from structural and functional connectivity, executive functions,~          and ADHD core symptoms stratifying by the ADHD and controls; and~        3. to explore other circuitries that may involve in ADHD by using whole brain tractography~          analyses.~   "
63015|NCT02232451|"~     The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip~     for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk~     patients.~   "
63016|NCT02232438|"~     At present, there are no established treatments for depression or anxiety in adolescents~     with cancer, creating an important clinical and research gap. Fortunately, there is now~     substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed~     and anxious adolescents in the general population.~   "
63017|NCT02232425|"~     The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong~     premature ejaculation.~   "
63018|NCT02232412|"~     Critically ill patients are frequently transfused with red blood cell (RBC) units with the~     predominant intention to increase arterial oxygen content and thus oxygen delivery to the~     tissues.~      To date, RBC transfusions have been proven effective in patients with profound anaemia or~     circulatory shock. However, the impact of the storage process and the so-called storage~     lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding~     tissue oxygenation are much debated at present. Alterations of RBC physiology have been~     comprehensively described ex vivo. Reduced deformability, increased adhesiveness and~     aggregability of stored RBC impair their rheological properties; anaerobic cellular~     metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP)~     increases oxygen affinity and impairs oxygen release to the tissues.~      This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen~     saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near~     infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might~     require RBC transfusion. The monitoring is continued for the time of transfusion and the~     hours afterwards.~   "
63019|NCT02232399|"~     The aim of the study is to assess the ability of Levosimendan to reduce the postoperative~     acute kidney injury in pediatric patients undergoing surgery for congenital heart disease~     (CHDs). Young children, between the age of 1 to 12 months, with congenital heart disease in~     need of elective heart surgery will be included in this study.~      The trial will contain two study groups, 35 patients in each. One group will receive~     Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening~     agent during and after the operation. Milrinone is currently used as the drug of choice in~     many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney~     protecting function in addition to its heart muscle-strengthening properties.~      The primary objective of this study is to investigate the preventive effect of Levosimendan~     on postoperative acute kidney injury in pediatric patients undergoing surgery for their~     CHDs. Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common~     marker of kidney injury, will be measured daily.~      The treatment with Levosimendan or Milrinone will be started during the operation (after~     initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained~     at six occasions perioperatively. Patients will be followed 4 days after termination of~     treatment (totally 5 days).~      The duration of study will be 30 days (24 hours treatment + 4 days follow up +~     30-days-mortality registration).~      Creatinine is the primary outcome in this study. Inflammatory biomarkers and other relevant~     biomarkers will comprise the secondary outcome variables.~   "
63021|NCT02232373|"~     The purpose of the study is explore the issues that relate to testing a particular dietary~     treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with~     which to compare it. In this trial the investigators will look at its effect on symptoms of~     people with persistent disturbance in their bowel pattern 3 months after an intestinal~     infection with Campylobacter.~      The investigators will also look at the changes in gut bacteria that occur with the diet.~   "
63022|NCT02232360|"~     The purpose of this study is to determine effects of combination therapy with rosuvastatin~     and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary~     lesions with intermediate stenosis in patient with coronary artery disease, compared with~     rosuvastatin alone therapy.~   "
63023|NCT02232347|"~     The objective of the study is to compare the effects of 48 hours ketamine infusion versus~     sufentanil infusion on brain glutamate concentrations measured with microdialysis after~     traumatic brain injury.~      We hypothesize that ketamine infusion will decrease high glutamate values faster than~     sufentanil.~   "
63024|NCT02232334|"~     Global osteopathic manual treatments will decrease the severity score of the Gastroparesis~     Cardinal Symptom Index tool of patients with idiopathic gastroparesis.~      In this longitudinal controlled pre-test post-test group design, subjects with idiopathic~     gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can~     decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting~     and abdominal pain secondary to delayed gastric emptying. There is no known cause for people~     suffering from IG.~      According to the power analysis, the population will be utilized as the experiment group and~     the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index~     (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The~     subjects in the population will each fill out the GCSI initially and again after an two (2)~     week period to measure their symptoms during a control period. The same subjects will then~     be treated with global osteopathic manual treatments one (1) treatment every two (2) weeks~     for four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first~     (1st) treatment (which is the last day of the control period) and then two (2) weeks after~     the last treatment (day 42). In order to reject the null hypothesis, with a p value of <~     0.05 and a power of 0.8, a minimum of ten (10) subjects in the treatment group is required~     with a treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d,~     where d = mean difference/standard deviation.~      It is expected that the results will show improvement of symptoms through the data collected~     from the GCSI questionnaires in the treatment group. The results of this study could be~     significant and contribute to the osteopathic community validating the effectiveness of~     traditional osteopathic manual therapy as well as giving non-invasive options to people~     suffering from the disease since those who struggle with it have minimal treatment~     options--medicines with significant side effects, full or total stomach removal or gastric~     electrical stimulator implants.~   "
63025|NCT02232321|"~     Objectives To investigate the effect of achieving minimal disease activity (MDA) using a~     protocolized treatment strategy on the progression of subclinical atherosclerosis and~     arterial stiffness in psoriatic arthritis (PsA) patients.~      Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have~     less progression of subclinical atherosclerosis and arterial stiffness then patients who~     cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA.~      Design and subjects One hundred consecutive PsA patients will participate in this 2-year~     prospective, hospital-based, cohort study.~      Interventions All participants will receive 2-year tight-control treatment. Treatment will~     be adjusted according to a standardized protocol based on the European League Against~     Rheumatism (EULAR) recommendation and the Hong Kong guideline on the use of biologics every~     4-monthly aiming at MDA.~      Study instruments Carotid intima-media thickness (IMT) will be measured using~     high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV)~     by a dedicated tonometry system and augmentation index (AIx) by the SphygmoCor device.~      Main outcome measures and analysis The main outcome measure is the change in IMT over a~     period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to~     those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the~     changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT,~     AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.~   "
63026|NCT02232308|"~     To assess if oral nizatidine or lisinopril alone and in combination will increase heme~     oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy~     subjects.~   "
63027|NCT02232295|"~     The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor~     functions and quality of life in patients with stroke that was conducted in two centers in~     india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary~     outcome measure was quality of life at 6 weeks.~      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions~     and quality of life in patients with stroke.~   "
63028|NCT02232282|"~     The investigators central hypothesis is that women with Interstitial Cystitis/Painful~     Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and~     acupuncture responders will have a differential urinary microbiome.~   "
63029|NCT02232269|"~     Hypertension affects an estimated 1.5 billion people world-wide and is a chief contributor~     to death, stroke, congestive heart failure, kidney disease, coronary artery disease and~     dementia. A number of important causal environmental factors have been identified and~     include excessive salt or alcohol consumption, physical inactivity, inadequate fruit,~     vegetable and potassium intake and obesity. Although there have been significant~     improvements in management, a high percentage of patients still do not achieve target blood~     pressures.~      Coffee is a popular beverage globally and elevates blood pressure variably among~     individuals. Customers in the United States comprise more than half of the population over~     the age of 18 years, consume an average of 1 cup (typical size: 270 ml) of coffee three~     times per day and spend an estimated $ 40 billion on the purchase of it each year. A major~     active constituent in coffee is caffeine, which is the most widely used pharmacological~     substance in the world.~      Drug therapy plays a major role in the management of hypertension. Concomitant intake of~     coffee is likely substantial. However, the interaction between coffee or caffeine and blood~     pressure lowering drugs has been assessed in only a few clinical studies conducted more than~     two decades ago. Moreover, it appears to have the potential to confound the routine drug~     management of hypertension.~      This clinical investigation reports the actions of a customary amount of coffee on the~     circulatory effects and blood concentrations of felodipine, a drug belonging to a class of~     drugs commonly used to treat hypertension. Application of results from this study to~     clinical practice has the possibility to improve the management of hypertension.~   "
63049|NCT02232009|"~     The investigational device studied is an MR Scanner for neonates and infants with a small~     size profile that makes it capable of being sited in a NICU or other neonatal and infant~     care units.~      The study hypothesis is to demonstrate feasibility of attaining diagnostic quality images~     and data using the MR scanner for neonates and infants with various hardware and software~     configurations.~   "
63030|NCT02232256|"~     California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild~     sedative and/or sleep aid. However there are no human clinical trial data to support its~     use. Sleep disturbances are a well-recognized component of chronic pain, and lead to~     additional social withdrawal, greater pain and worsening depression. Most hypnotics~     available either place the patient at further risk (e.g. benzodiazepines combined with~     opioids increase the risk of central or obstructive sleep apnea), increase adverse events~     (dry mouth, daytime somnolence, etc.) or induce sleep but do not improve the quality of~     sleep (no increase in Rapid Eye Movement or curative sleep). This study intends to use~     California Poppy to avoid adverse effects while improving sleep. An open-label clinical~     trial was performed to obtain preliminary safety and efficacy information of California~     poppy. This trial was approved by a central ethics review board. The study results showed~     that California poppy, can be used as a co-analgesic to provide additional analgesia and/or~     sleep improvement to the patient. Patients who are referred to the clinic will be asked to~     complete a few short questionnaires at every visit and on monthly basis respectively. This~     data, in addition to the usual follow-up questionnaires used by the clinics' physicians~     (McGill Pain Intensity, Pain Disability Index, Short-form Health Survey-12v2) and general~     demographic and medical information will be used to assess California Poppy's effectiveness~     on patients~   "
63031|NCT02232243|"~     Baseline levels of PAR-4 secreted by normal cells are generally inadequate to cause massive~     apoptosis in cancer cells and drugs that bolster the secretion of PAR-4 would constitute an~     important therapeutic advance.The apoptosis sensitizing features of hydroxychloroquine~     enhance the anti-tumor effects of a broad range of cancer therapeutics. The investigators~     hypothesize that hydroxychloroquine will induce at least 2-fold increase in systemic~     (plasma) PAR-4 levels compared to pre-treatment plasma levels in patients with resectable~     solid tumors.~   "
63032|NCT02232230|"~     Radiation in combination with Provenge based immunotherapy may improve outcomes seen on~     imaging as well as immunologic monitoring. This study will assess the effect of radiation~     therapy to augment anti-tumor responses from immune therapy with Provenge.~   "
63033|NCT02232217|"~     The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the~     efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in~     an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep~     disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly~     assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address~     behavioral sleep issues in children; EC will address sleep and dietary education and general~     coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height,~     weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime~     sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is~     hypothesized the children in the CBTcs will experience greater improvement in sleep than~     children in the EC.~   "
63034|NCT02232204|"~     This is a single-center, randomized controlled trial study design. Enrolled participants~     have a cardiovascular condition for which they are undergoing implantable cardioverter~     defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a~     behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment~     intervention period lasted 4 weeks with a telephone booster session administered at 3 month~     follow-up. The objective of the study is to examine the impact of a brief therapy combining~     established behavioral approaches to treating insomnia with novel components to target~     negative cognitions and anxieties associated with cardiac disease and ICD implantation.~     Primary patient outcomes include sleep, psychological functioning, daytime functioning,~     cardiac functioning, cognitive performance, and ICD adjustment.~   "
63035|NCT02232191|"~     Persons without a spleen are susceptible to potentially lethal infections from certain~     bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect~     against these infections, though they do not so with certainty. Trauma patients who sustain~     an injury to their spleen currently have three treatment options available for the treating~     surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of~     this study is to investigate the antibody response to pneumococcal vaccine in patients~     undergoing these modes of therapy.~   "
63036|NCT02232178|"~     Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy~     hernioplasty and assess the relative bioavailability of Xaracoll compared to a local~     bupivacaine infiltration.~   "
63037|NCT02232165|"~     Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend~     maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days~     after SCI as a clinical option. Unfortunately, the medical evidence to support this~     recommendation exists only at the clinical case series level (Class III data). Furthermore,~     maintenance of sustained systemic hypertension, as per clinical guidelines, may be~     associated with risks to the patient via adverse medical events. Given this equivocal~     evidence, the investigators group has questioned the merit of sustained induced hypertension~     following acute SCI and has previously conducted a randomized, prospective controlled~     feasibility study to further examine this issue. This prior pilot study randomized patients~     with acute SCI to a spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP))~     target of ≥ 75 mmHg or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The~     primary endpoint measure was defined as the change in American Spinal Injury Association~     (ASIA) motor score from baseline. No difference in the primary outcome was noted at one-year~     post-SCI in this study.~      In light of this pilot data, the investigators hypothesize that maintenance of normotension~     (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following~     acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority~     prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized~     into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP~     ≥ 65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint~     will be change in ASIA motor score from baseline at 12 months post injury. A difference of~     ≤10 ASIA motor points change from baseline between groups will be considered as~     non-inferiority. Secondary endpoints will include ASIA sensory score, proportion of patients~     achieving a one grade improvement in ASIA impairment scale, quality of life assessment (as~     measured by Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord~     Independence Measure (SCIM) and Functional Independence Measure (FIM). These will be~     measured at baseline, 72 hours and 3, 6 and 12 months from injury. Adverse events will be~     meticulously recorded. The information gleaned from this trial will provide valuable~     information for the acute treatment of traumatic SCI and will serve the objective of~     optimizing current clinical practice and thus maximizing medical and neurological outcome~     for individuals following acute traumatic SCI.~   "
63050|NCT02231996|"~     CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the~     subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who~     are diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine,~     including clinical feature, laboratory data and genetic information. we aim to find out~     clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus~     further improving the level of diagnosis and treatment for CGD.~   "
63038|NCT02232152|"~     This pilot phase I trial studies the side effects and best dose of CPI-613 when given~     together with fluorouracil in treating patients with colorectal cancer that has spread to~     other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by~     turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and~     are the building blocks needed to make more tumor cells. By shutting off these mitochondria,~     CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and~     grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more~     tumor cells.~   "
63039|NCT02232139|"~     The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test~     (4CRT) as a measure for recovery of the psychomotor function in patients after general~     anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in~     general anesthesia, will be randomized to the group with pharmacological anxiolytic~     premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients~     will be monitored using 4CRT before and after standardized general anesthesia. The reaction~     time, measured with 4CRT is the primary outcome parameter of the investigation.~   "
63040|NCT02232126|"~     In response to Program Announcement (PA)-09-164, NIH Exploratory/Developmental Research~     Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work~     Intervention Focused on Transitions among at-risk older adults following hospital discharge~     to home. This study is drawn from several observations. First, transitions between care~     settings create elevated risk for poor outcomes and for readmission among older adults~     leaving the hospital for home largely due to fragmented care and poor communication. Next,~     while few studies exist that test methods to improve transitions, those available are~     largely medically focused, using a nurse or advanced practice nurse in their approach.~     Although evidence exists to support the effectiveness of these models, few have been~     replicated and none have been integrated into standard health care practice. This may be~     attributed to several factors including the availability of the needed staff, the lack of~     existing structures to support these roles, and the costs of implementing these~     interventions. Finally, a social work driven intervention may provide a replicable mechanism~     for bridging medical care, addressing psychosocial needs as well as medical needs, and~     improving linkages with community services while reducing care duplication. This study aimed~     to test a structured social work transition intervention model to reduce rates of hospital~     readmission and medical service use while improving patient satisfaction with the care~     transition process. A randomized pilot study was used to test a social work transitions~     model designed to improve care provided to frail older adults being discharged from the~     hospital to return to the community. Eligible patients consenting to participate (n=181)~     were randomly assigned to either the social work transitions model intervention or usual~     care. This project was conducted at Huntington Hospital, a 525-bed, nonprofit, community~     hospital located in Pasadena, California. In an average year, Huntington Hospital has~     approximately 10,000 older adults discharged from their facility, 44% of who are 80 years~     old or older. Those randomized to the intervention arm received up to six sessions from the~     social worker, at least one provided in the home. The social work intervention was designed~     to overcome common problems following hospital discharge including medication review,~     discussion and planning around discharge instruction, assistance in scheduling follow up~     appointments, assessments of psychosocial and other support service needs and provision of~     linkages to address those needs. Outcomes were measured three and six months following~     arrival at home, with an interim measure of satisfaction at 10 days following arrival at~     home, with measures including patient level of depression, pain, physical functioning,~     self-efficacy with disease management, and medical service use.~   "
63041|NCT02232113|"~     The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose~     interval and the survey for influence factors:~      We aim to evaluate a better clinical response which can be achieved by different dosing~     interval of a fixed dose of CERA. We expect this study can determine the dosing schedule~     with better clinical response to CERA and identify the associated factors predicting the~     cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.~   "
63042|NCT02232100|"~     Chronic musculoskeletal pain is a complex medical condition associated with significant~     distress, disability, and reduction in quality of life. Research has shown that patients~     with chronic musculoskeletal pain demonstrate attentional biases towards pain-related~     information.~      The purpose of this study is to determine whether internet-delivered attentional bias~     modification, which aims to implicitly train attention away from pain-related information,~     has beneficial effects upon pain and pain-related distress in patients with chronic~     musculoskeletal pain.~      Participants will be randomised to either an attentional training condition, or to a~     no-training placebo condition. The primary outcome measures are pain intensity and pain~     interference, and secondary outcome measures include anxiety, depression, pain-related fear~     and sleep problems.~      It is hypothesized that participants receiving internet-delivered attentional bias~     modification will show significantly greater reductions in pain and pain-related distress~     compared to participants receiving placebo training.~   "
63043|NCT02232087|"~     The purpose of this study is to test the body's response to several doses of two different~     inhalation products in healthy volunteers.~   "
63044|NCT02232074|"~     The investigators plan to compare standard patient navigation with an enhanced navigation~     partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal~     needs of newly diagnosed cancer patients in addition to other barriers to care leads to~     better clinical outcomes.~   "
63045|NCT02232061|"~     This study will evaluate if patients who had a serious cardiovascular event upon initiation~     of fingolimod are at risk to delevop long term other cardiovascular events~   "
63046|NCT02232048|"~     Patients hospitalized in internal medicine departments are given corticosteroid treatment~     according clinical indications. Patients receive treatment at different dosage levels and in~     different preparations according to clinical indications. This study will investigate how~     corticosteroids effect the heart and specifically, longitudinal strain.~   "
63047|NCT02232035|"~     Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to~     increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress~     and asphyxia and requires early detection and appropriate clinical response. The risks for~     complications of prolonged labour are much greater in poor resource settings. Active~     management of labour versus physiological, expectant management, has shown to decrease the~     occurrence of prolonged labour. Administering sedatives during labour could also lead to~     faster and more effective dilatation of the cervix. Interventions to shorten labour, such as~     sedatives, can be used as a preventative or a treatment strategy in order to decrease the~     incidence of prolonged labour. As the evidence to support this is still largely anecdotal~     around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane~     Database of Systematic Reviews 2012, CD009223.pub2.)~      Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.~   "
63048|NCT02232022|"~     The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation~     (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial~     fibrillation.~   "
63053|NCT02231957|"~     There are a growing number of adolescents with chronic medical conditions in the United~     States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination~     and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination~     is also recommended for certain high-risk patients. Limited studies suggest that vaccination~     coverage of this population remains sub-optimal. Text message vaccine reminder/recall has~     been shown to be effective in increasing uptake of select pediatric and adolescents~     vaccines, but has yet to be examined among patients with chronic medical conditions who may~     also face unique barriers to vaccination. This intervention aims to implement and evaluate~     the use of text message vaccine reminders among urban low-income minority adolescents with~     chronic medical conditions. This investigator-initiated study is supported in part by a~     grant from the Pfizer Medical Education Group.~   "
63054|NCT02231944|"~     To compare the first and second recovery assessments on Replenine®-VF and to evaluate~     recovery of different batches if patients changed batches during the study.~      To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety~   "
63055|NCT02231931|"~     To investigate the mutual interaction potential of digoxin, furosemide, metformin, and~     rosuvastatin when given alone or together as a cocktail, and to investigate the effect of~     high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds~   "
63056|NCT02231918|"~     Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a~     single dose orally (p.o.) in pediatric patients with the diagnosis of RLS~   "
63057|NCT02231905|"~     Study to assess the safety, tolerability and effectiveness of a switching from Domin®~     (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease~   "
63058|NCT02231892|"~     Background:~      - Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help~     people quit drugs. Researchers want to study how it works in healthy people first.~      Objective:~      - To learn how to use rTMS to stimulate a brain area and to see how it affects brain~     function and thinking.~      Eligibility:~      - Healthy, right-handed adults ages 18-55.~      Design:~        -  Participants will be screened under another protocol.~        -  They will have 4-11 study visits.~        -  To start each visit, participants will have:~        -  Physical exam.~        -  Urine sample.~        -  Breath tests for alcohol and cigarette smoke.~        -  Questions about drug use and medications.~        -  Visit 1: participants will have:~        -  Single TMS pulses on the head to determine the right strength. They will wear earplugs~          and a cap. A wire coil will be placed on the head and an electrical current will go~          through it. Participants may perform simple muscle movements. They will repeat the~          procedures wearing another coil, in a helmet.~        -  A few TMS pulses to show how rTMS feels.~        -  A practice thinking task, maybe in a scanner that looks and sounds like a magnetic~          resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal~          cylinder surrounded by a strong magnetic field. The participant will lie on a table~          that slides in and out of the cylinder.~        -  They may have a real MRI scan.~        -  Visits 2-11, participants will:~        -  Complete two questionnaires.~        -  Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored.~        -  Have their vital signs checked.~        -  They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner.~          They may just lie still in the MRI scanner.~   "
63059|NCT02231879|"~     Background:~      - WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare~     disease. It can cause cancers, infections, and warts. Researchers want to see if a drug~     called plerixafor can treat WHIMS.~      Objective:~      - To compare plerixafor versus granulocyte colony stimulating factor (G-CSF) for preventing~     infections in people with WHIMS.~      Eligibility:~      - People ages 10 75 with WHIMS who have a CXCR4 gene mutation.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and~          urine tests. They may have heart and spleen tests and body scans. They may have samples~          of skin or warts taken. Researchers may take photographs of warts.~        -  Participants will start twice daily self-injections of G-CSF. Their doctors will decide~          the dosage.~        -  Initial Period (4 12 weeks)~        -  Participants will:~        -  continue the injections and their usual antibiotics and/or immunoglobulin~        -  have blood drawn~        -  keep a daily health diary~        -  Participants will visit the clinic for 2 days without injections.~        -  Adjustment Period 1 (8 weeks):~        -  Participants will:~        -  continue twice daily injections from home~        -  continue the daily health diary~        -  have blood tests every 2 weeks.~        -  Treatment Year 1:~        -  Participants will~        -  receive either plerixafor or G-CSF injections twice daily~        -  continue the health diary~        -  have blood tests every 2 months~        -  visit the clinic about every 4 months~        -  At the end of year 1, participants will visit the clinic for an evaluation. They will~          switch to the other study drug. They will have an 8-week adjustment and 1-year~          treatment period.~        -  At the end of year 2, participants will visit the clinic to complete their injections~          and go back to their previous G-CSF regimen. Participants will continue their daily~          health diary and have blood tests for 5 6 months.~   "
63060|NCT02231866|"~     Background:~      - Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is~     impossible for someone to get an Ebola infection from this vaccine.~      Objectives:~      - To see if an Ebola vaccine is safe and to study immune responses to it.~      Eligibility:~      - Healthy adults ages 18-65.~      Design:~        -  Participants will be screened through a separate protocol.~        -  Participants will receive the vaccine injection by needle and syringe into an upper arm~          muscle. - Participants will stay at the clinic for 3 hours after the injection.~        -  About 2 days later, participants must speak with clinic staff about how they are doing.~        -  Every day for 7 days after the injection, participants will record their temperature~          and symptoms and look at the injection site. They will get a thermometer and a ruler to~          measure any redness or swelling. They will report any side effects.~        -  In the first 2 months in the study, participants will have at least 6 clinic visits and~          1 phone call. They will have at least 3 other visits over the next 9 months.~        -  At each visit, participants will be checked for health changes or problems since their~          last visit. They will be asked how they feel and if they have taken any medicine. Blood~          will be drawn at most visits. Urine samples may be collected.~   "
63061|NCT02231853|"~     Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life~     threatening viral reactivation. Conventional antiviral therapy is suboptimal for~     cytomegalovirus (CMV), adenovirus (AdV) and Epstein-Barr virus (EBV) and nonexistent for BK~     virus (BKV). An alternative approach to prevent viral reactivation is to infuse~     virus-specific cytotoxic T cells (CTL) prepared from the donor early after SCT. Such~     multivirus-specific CTL cells (MVST) have been successfully used in a number of centers to~     prevent or treat CMV, Ad and EBV. Activity of BKV-reactive cells has not been studied. Multi~     virus-specific T cells (MVST) are donor lymphocytes that are highly enriched for viral~     antigens and expanded in vitro before infusion into the transplant recipient. Viral~     reactivation is a particular problem inT cell depleted SCT. Median time to CMV reactivation~     is estimated as 28 days post T-depleted transplant, but infusion of MVST within the~     immediate post-SCT period has not been previously studied. This protocol will be the first~     of a planned series of cellular therapies to be layered on our existing T lymphocyte~     depleted transplant platform protocol 13-H-0144.~      The aim of this study is to determine the safety and efficacy of very early infusion of MVST~     directed against the four most common viruses causing complications after T-depleted SCT.~     GMP-grade allogeneic MVST from the stem cell donor will be generated using monocyte-derived~     donor dendritic cells (DCs) pulsed with overlapping peptide libraries of immunodominant~     antigens from CMV, EBV, Ad, and BKV and expanded in IL-7 and IL-15 followed by IL-2 for~     10-14 days. A fraction of the routine donor leukapheresis for lymphocytes obtained prior to~     stem cell mobilization will be used to generate the MVST cells. MVST passing release~     criteria will be cryopreserved ready for infusion post SCT.~      Eligible subjects on NHLBI protocol 13-H-0144 will receive a single early infusion of MVST~     within 30 days (target day +14, range 0-30 days) post SCT. Phase I safety monitoring will~     continue for 6 weeks. Viral reactivation (CMV, EBV, Ad, BK) will be monitored by PCR by~     serial blood sampling. The only antiviral prophylaxis given will be acyclovir to prevent~     herpes simplex and varicella zoster reactivation. Subjects with rising PCR exceeding~     threshold for treatment, or those with clinically overt viral disease will receive~     conventional antiviral treatment. Patients developing acute GVHD will receive standard~     treatment with systemic steroids. These patients are eligible for reinfusion of MVST when~     steroids are tapered.~      The clinical trial is designed as a single institution, open label, non-randomized Phase~     I/II trial of MVST in transplant recipients, designed as 3-cohort dose escalation Phase I~     followed by a 20 subject extension Phase II at the maximum tolerated dose of cells. Safety~     will be monitored continuously for a period of 6 weeks post T cell transfer. The primary~     safety endpoint will be the occurrence of dose limiting toxicity, defined as the occurrence~     of Grade IV GVHD or any other SAE that is deemed to be at least probably or definitely~     related to the investigational product. The primary efficacy endpoint for the phase II will~     be the proportion of CMV reactivation requiring treatment at day 100 post transplant.~     Secondary endpoints are technical feasibility of MSVT manufacture, patterns of virus~     reactivation by PCR, and clinical disease from EBV, Ad, BK, day 100 non-relapse mortality.~   "
63081|NCT02231593|"~     The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated~     comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported~     Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will~     determine the potential use of a finalised operational version for patient classification in~     clinical practice and studies.~      In addition, this study intends to carry out a qualitative evaluation of the acceptability~     of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability~     and usefulness of the tool in practice.~   "
63150|NCT02230683|"~     This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of~     IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.~   "
63062|NCT02231840|"~     Background:~      - About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow~     people that have alcohol problems and want treatment, as well as those who do not want~     treatment and healthy volunteers. They also want to gather information on people with and~     without alcohol problems, including information on genes and biological processes in the~     body.. This will help them better understand, prevent, and treat alcohol problems.~      Objective:~      -To look at a broad range of traits in people who are healthy people and people with alcohol~     problems. To study them for potential eligibility for other research protocols conducted at~     the NIH Clinical Center.~      Eligibility:~        -  Adults age 18 and older.~        -  Not being pregnant or imprisoned.~      Design:~        -  Participants will have a physical exam. They will answer questions about their health~          and alcohol and drug use. They will have an electrocardiogram to check their heart.~          They will have blood, urine, and breath alcohol tests.~        -  Participants without alcohol problems, or who have them but do not want treatment, can~          sign the second consent for screening and research.~        -  Participants that have alcohol problems and want treatment will be treated at the NIH~          Clinical Center. They will be offered to sign the second consent at a later time.~        -  Participants may join an inpatient treatment and detox program. It could last up to 6~          weeks. Or they may join an outpatient program. Some may do both.~        -  After discharge, participants may be called and asked questions about their drinking~          and health.~        -  If participants sign the second consent, they:~        -  will complete paper- and computer-based questionnaires.~        -  will give blood samples.~        -  may have a brain scan using magnetic resonance imaging. They will lie on a table that~          slides in and out of a cylinder that takes pictures. The machine makes loud noises.~          They will get earplugs.~   "
63063|NCT02231827|"~     Gait and balance disorders are important public health problem necessitating studies to try~     to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance~     during quiet standing (posturography). Nevertheless, falls occurred predominantly during~     gait, and rarely during quiet standing. We have developed a tool to measure balance during~     gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the~     vertical velocity of the CM recorded with a force plate.~      In previous studies, we have shown that the braking of the CM was a physiological and a~     active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM~     measured on a force plate provide an important intra-individual variability.~      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The~     primary goal of this study is to compare intra-individual variability of the braking of the~     CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in~     healthy subjects.~   "
63064|NCT02231814|"~     This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's~     Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED~     alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks.~   "
63065|NCT02231801|"~     This observational study aims to monitor the vital sign changes in both mother and baby that~     occur during kangaroo care in preterm infants and to investigate any potential correlations~     between maternal measurement values and those of the infant. The purpose of this~     observational study is to look for a method to track the earliest responses that could,~     theoretically, be considered as 'social responses' in hopes of providing developmental~     interventions earlier to at-risk infants.~   "
63066|NCT02231788|"~     The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory~     BP Control Compared with Telmisartan Monotherapy~   "
63067|NCT02231775|"~     The goal of this clinical research study is to compare receiving the combination of~     dabrafenib and trametinib before surgery to having surgery alone in patients with melanoma.~     The safety of the study drug combination will also be studied.~   "
63068|NCT02231762|"~     The purpose of the study is to evaluate the efficacy and tolerability of the combination of~     Lanreotide Autogel 120 mg and Temozolomide in patients with progressive~     gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All~     progressive tumours classified according to Response Evaluation Criteria In Solid Tumours~     (RECIST, 1.1).~   "
63069|NCT02231749|"~     The purpose of this study is to compare the objective response rate, progression free~     survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib~     monotherapy in patients with previously untreated Renal Cell Cancer.~   "
63070|NCT02231736|"~     The purpose of the study is to determine whether glycemic control (HbA1c) is linked to~     chromosomal damage in type 2 Diabetes patients~   "
63071|NCT02231723|"~     This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered~     in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with~     5-FU and leucovorin.~   "
63072|NCT02231710|"~     The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells~     infused after a haplo-identical stem cell transplant to facilitate engraftment and the~     safety of AP1903 on day 7 to prevent GVHD.~   "
63073|NCT02231697|"~     This retrospective medical chart review (RECENSUS) of approximately 100 XLMTM patients (with~     a goal to obtain 50 deceased and 20 living records) will provide further knowledge about the~     clinical manifestations and recorded medical management of XLMTM and potentially inform the~     design of future therapeutic intervention studies.~   "
63074|NCT02231684|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of~     three different strengths of semaglutide and the absolute bioavailability of semaglutide.~   "
63075|NCT02231671|"~     The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed~     from the body.~   "
63076|NCT02231658|"~     The present study will compare lixisenatide and liraglutide in a population of subjects with~     T2DM not optimally controlled on OADs and / or insulin, which is the target population for~     these medications.~   "
63077|NCT02231645|"~     The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN~     DBS) can affect moral and economic decisions in patients with Parkinson's disease (PD).~   "
63078|NCT02231632|"~     The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live~     attenuated Poliomyelitis vaccine (human diploid cell)~   "
63079|NCT02231619|"~     The purpose of the study is to design a self-assessment package that could be the preferred~     option to a follow-up visit at the clinic by the majority of women having early medical~     abortion.~   "
63080|NCT02231606|"~     The aim of the project is to create, study and advocate for a model that can be adopted by~     the Chinese government to provide spectacles for all children sustainable.~   "
63082|NCT02231580|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for~     28 days in patients with Huntington's Disease (HD).~   "
63083|NCT02231567|"~     The purpose of the study is to evaluate the effectiveness of an approach based on~     neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose~     solution involves the use of higher cognitive functions (attention, memory, language), not~     required in a traditional approach proprioceptive, in order to obtain a more complete and~     long-lasting recovery.~   "
63084|NCT02231554|"~     The purpose of this study study is to determine whether the Feldenkrais method is effective~     on pain control, functional recovery and quality of life in patients with chronic low back~     pain by comparing it with a Back School program.~   "
63085|NCT02231541|"~     The purpose of the study is to determine the effectiveness of treatment with very low~     frequency electromagnetic fields on the reduction of pain in patients with fibromylgia,~     disease presenting with widespread musculoskeletal pain usually associated with other~     symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.~   "
63086|NCT02231528|"~     The GPS system would simplify the technical implementation of central venous catheter under~     ultrasound guidance. We can assume that the introduction of deep venous pathways (as a~     reference, the internal jugular) will be faster, and this, whatever the level of expertise.~     By checking this hypothesis, this technique could be applied to much less frequent~     situations establishment of difficult central venous catheters (hemodynamic status~     precarious, hypovolemia, or cardiac arrest).~      The main objective of this study is to evaluate the time savings provided by the ultrasound~     assisted GPS guidance for installing central venous catheters in the internal jugular.~     Central venous catheters are inserted in the operating room under conditions scheduled in~     advance that is to say outside emergency. The installation time for the central venous~     catheter is compared with that obtained by using the ultrasound machine without the GPS~     guide (conventional technique).~   "
63087|NCT02231515|"~     A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of~     selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with~     open-angle glaucoma.~   "
63088|NCT02231502|"~     The purpose of this study is to establish to what extent innovations in food production~     techniques may facilitate retention of bioactive compounds in healthy individuals.~      The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma~     concentration and urinary excretion levels of a range of bioactive compounds will be~     assessed over a 24 hour period following intake of either a vegetable based convenience~     food, or a minimally processed meal containing the same vegetable materials.~      To do this, 20 healthy volunteers will attend two assessment days (and a follow-up~     assessment at +24hr) and will provide blood and urine samples, which will be collected at~     biologically relevant times over the 24 hour period. In this cross-over study, each meal~     will be eaten on separate days, with a wash-out period of at least 1 week between~     assessments.~   "
63089|NCT02231489|"~     The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral~     dose of capsule (reference) versus tablet (test) in healthy participants.~   "
63090|NCT02231476|"~     Bone metastasis causes bone destruction and skeletal related events (SRE) including~     compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative~     treatments for pain control and local control have become important and multidisciplinary~     multimodality approach is needed for treatment of bone metastasis.~      The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that~     bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In~     previous retrospective reports, the combination of local RT and systemic bisphosphonate was~     more effective than RT alone.~      Therefore, the investigators designed a phase II study to evaluate the efficacy of RT in~     combination with zoledronic acid on pain relief and the safety of RT in bone metastasis~     patients with gastrointestinal tumors.~   "
63091|NCT02231463|"~     In 50 Patients who are undergoing a planned surgical procedure which require a central~     venous catheter the diameter of the subclavian vein is measured by ultrasound under 6~     different conditions.~   "
63092|NCT02231450|"~     The purpose of this study is to assess the impact of mild to moderate hepatic impairment on~     the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054~   "
63093|NCT02231437|"~     The aim of this post-marketing surveillance is to obtain further information about the~     tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive~     respiratory tract disease under conditions of daily practice~   "
63094|NCT02231424|"~     The aim of this postmarketing surveillance is to obtain further information about the~     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic~     obstructive respiratory tract disease under conditions of daily practice~   "
63095|NCT02231411|"~     The purpose of this study is to examine whether providing ventilation during delayed~     umbilical cord clamping provides greater placental transfusion and improved hemodynamic~     transition at birth.~   "
63096|NCT02231398|"~     This study is looking at the relationship between experiences during pregnancy and~     cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the~     approximately 10,000 women who were enrolled and followed over the course of their first~     pregnancy in another study.~   "
63097|NCT02231385|"~     The purpose of this study is to compare the additional diagnostic yield obtained by using~     the acetic acid as vital substance to improve the detection of serrated lesions at~     colonoscopy.~      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be~     recruited to the study and randomized to one of two groups. Each enrolled subject will~     undergo two back-to-back procedures limited to the examination of the right colon.~      Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon~     has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from~     cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B~     (control group) will undergo a second examination of the right colon without acid acetic and~     within the same frame-time.~      Results from the two groups will be analyzed and compared, with primary outcome measures~     being detection rates for serrated lesions. Secondary outcome measures will include adenoma~     detection rate in the right colon or other locations, characteristics of polyps detected,~     including size and histological results.~      Subjects will be followed through a 24-72 hour telephone interview for analysis of~     unexpected adverse events. Clinical results will be analyzed using various statistical~     measures of significance.~   "
63101|NCT02231333|"~     Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily~     outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and~     so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the~     future. It is a spectrum of hepatic pathology, ranging from simple steatosis,~     steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form~     of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of~     inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis.~     NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out~     of which 49 RCTs have been done till date to define the appropriate treatment of~     nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment~     available till date. Recently published PIVENS trial has shown that Vitamin E has proven~     benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the~     form of histological improvement and biochemical improvement in the form of liver enzymes.~     Role of SAMe has been studied in alcoholic liver disease and showed to improve in both~     biochemical and histological features. However the usefulness of SAMe in NAFLD is not known~     till now. Hence this study has been designed.~   "
63102|NCT02231320|"~     New perceptions about handling and patient satisfaction of the everyday use of Berodual®~     Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further~     knowledge should be attained about the tolerability of Berodual® Respimat®~   "
63103|NCT02231307|"~     The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in~     reducing birch allergy induced symptoms and birch allergy medication usage.~   "
63104|NCT02231294|"~     Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability~     in ambulatory patients suffering from idiopathic Parkinson's disease under routine~     conditions~   "
63105|NCT02231281|"~     The purpose of this study is to assess the ability of the early initiation of cART or cART~     in combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to~     achieve a post-treatment control among treatment-naïve acute HIV-infected adults.~   "
63106|NCT02231268|"~     -  Evaluation of a 6-months treatment with Gladem~        -  Experiences with the internet for performing a postmarketing study (PMS) trial~   "
63107|NCT02231255|"~     Documentation of the effect of an direct or overlapping switch from another dopamine agonist~     to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the~     reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the~     switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic~     Parkinson's disease under routine conditions~   "
63108|NCT02231242|"~     The purpose of this study is to determine whether the infusion of intrathecal autologous~     bone marrow total nucleated cells would improve the neurologic evolution of pediatric~     patients with quadriparetic cerebral palsy.~   "
63109|NCT02231229|"~     French guidelines currently recommend to initiate a 4-drug containing regimen associating~     isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol~     (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind~     routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of~     primary resistance to INH. Hence, early detection of resistance to INH and RIF using~     molecular testing in Mycobacterium tuberculosis could allow early adaptation of~     antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and~     PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth~     susceptibility testings.~      the duration of treatment is 6 months or 12 months.~   "
63110|NCT02231216|"~     Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is~     responsible for an increase in quality of life related to nasal obstruction when compared to~     no intervention in rhinoseptoplasty inferior turbinate?~        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic~        -  Intervention: surgery, turbinectomy of inferior turbinates~        -  Comparison: the absence of intervention in inferior turbinates~        -  Primary endpoint: Quality of life related to nasal obstruction~   "
63111|NCT02231203|"~     Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism~     that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled~     inflammatory response, however may lead to catabolism, tissue damage and organ failure.~     Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of~     the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells,~     they trigger intracellular signalling pathways that result in a less pro-inflammatory~     response. They modify gene and protein expression, modulate membrane protein activity and~     act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect~     by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve~     erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation~     and wound healing.~      The investigators hypothesize that the perioperative administration of intravenous omega-3~     fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby~     reducing the postoperative inflammatory response and improving erythrocyte function in~     patients undergoing colorectal surgery.~   "
63112|NCT02231190|"~     As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from~     unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study~     is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after~     unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or~     placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863~     on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1~     subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral~     doses of GSK1278863/placebo in total. The first dose will be administered immediately after~     completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be~     housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.~     After enrolment of approximately 30 subjects, enrolment will be paused and planned interim~     analysis will be performed to decide whether to terminate enrolment/study, continue dosing~     or to reduce the dose to 5 milligrams (mg).~   "
63151|NCT02230670|"~     This is a multicenter study to see if treatment with IDN-6556 can help improve the liver~     function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores~     between 11-18.~   "
63113|NCT02231177|"~     The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium~     at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL~     plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at~     steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg~     tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.~      The secondary objectives were to compare the safety and tolerability (adverse events,~     12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and~     tiotropium bromide when administered as fixed dose combination or as single-agent therapy.~   "
63114|NCT02231164|"~     The present trial will investigate the efficacy and safety of nintedanib in combination with~     docetaxel as compared to placebo in combination with docetaxel in patients with stage~     IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line~     platinum-based chemotherapy.~   "
63115|NCT02231151|"~     The investigators will look at how accurate pediatric healthcare workers are at judging~     quality of Cardiopulmonary Resuscitation, by observation of the chest compressions, and if~     they are more accurate at a certain position near the patient. The investigators will do~     this by having participants fill out a survey about the quality of the Cardiopulmonary~     Resuscitation in several recorded resuscitation scenarios.~   "
63116|NCT02231138|"~     Huangkui Capsule is a single medicament of traditional Chinese medicine consists of~     Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this~     study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic~     kidney disease in large scale samples with long time take.~   "
63117|NCT02231125|"~     -IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is~     a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has~     been widely used to treat kidney disease. The purpose of this study is to evaluate the~     safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale~     samples with long time take.~   "
63118|NCT02231112|"~     It is well known fact that postoperative whole breast radiation therapy (RT) in left breast~     cancer patient can cause cardiac problem according to the exposed dose. In the several~     studies in other countries, it was repeatedly showed that RT on prone position can reduce~     cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position~     in RT is not studied in the Korean women have relatively small breast. The investigators~     planned this study to evaluate the real efficacy of prone position in Korean breast cancer~     treated with RT.~   "
63119|NCT02231099|"~     Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of~     pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need~     for improvement of the surgical techniques currently used. Placement of a mesh aims at~     reducing the recurrence rate.~      In this study the investigators compare the effectiveness of the Tension free Vaginal mesh +~     Monocryl with standard vaginal prolapse surgery without mesh.~   "
63120|NCT02231086|"~     This study aims to determine the oncological effectiveness of adjuvant HIPEC, using~     intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of~     a T4 or intra-abdominally perforated Colon cancer in preventing the development of~     peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.~      Hypothesis:~      The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p.~     oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or~     intra-abdominally perforated colon cancer reduces the development of peritoneal~     carcinomatosis in comparison to standard adjuvant systemic treatment alone.~   "
63121|NCT02231073|"~     There is emerging research detailing the relationship between balance/gait/falls and~     cognition. Imaging studies also suggest a link between structural and functional changes in~     the frontal lobe (a region commonly associated with cognitive function) and mobility. People~     with Parkinson's disease have important changes in cognitive function that may impact~     rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal~     lobe connections with the basal ganglia and brainstem posture/locomotor centers are~     responsible for postural deficits in people with Parkinson's disease and play a role in~     rehabilitation efficacy. The purpose of this study is to 1) determine if people with~     Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively~     challenging mobility exercise program and 2) determine if cognition and brain circuitry~     deficits predict responsiveness to exercise rehabilitation.~      Design: This study is a randomized cross-over controlled intervention to take place at a~     University Balance Disorders Laboratory. The study participants will be people with~     Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6~     weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a~     cognitively challenging program based on the Agility Boot Camp for people with PD. The~     education program is a 6-week program to teach people how to better live with a chronic~     disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are~     measures of mobility, cognition and neural imaging.~      Discussion: The results from this study will further our understanding of the relationship~     between cognition and mobility with a focus on brain circuitry as it relates to~     rehabilitation potential.~   "
63122|NCT02231060|"~     The primary objective of HOPE is to improve the accuracy of outcome prediction in~     anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny~     some of the existing methods used for this purpose (e.g. somato-sensory evoked potentials).~     HOPE is the first multicenter prospective cohort study on coma prognosis to control for the~     effect of a possible self-fulfilling prophecy at the ICU and to cover the acute and~     neurorehabilitation phases with a long-term follow-up longer than the usual three or six~     months.~   "
63123|NCT02231047|"~     The purpose of this study is to compare the occurrence of childhood diarrheal disease and~     pneumonia in subjects under the age of 5 years in low resource settings who have received~     prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not~     received prophylactic 64N.~   "
63124|NCT02231021|"~     This study evaluate the efficacy and safety of alogliptin and pioglitazone combination~     therapy in comparison with either alogliptin or pioglitazone on glucose control in the~     metformin-treated type 2 diabetic patients in Korea.~   "
63125|NCT02231008|"~     The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of~     individuals with Smith-Magenis Syndrome.~   "
63128|NCT02230969|"~     The primary objectives of the study are to determine the incidence of serious adverse events~     (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical~     practice and to assess the overall long-term clinical effectiveness of Plegridy in~     participants with relapsing forms of MS in routine clinical practice. The secondary~     objectives of this study in this study population are to describe Plegridy prescription and~     utilization adherence patterns in routine clinical practice; to assess the specific~     long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in~     routine clinical practice; to monitor the safety and tolerability of Plegridy in routine~     clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms~     (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading~     to treatment discontinuation; to assess the effect of FLS on participant-reported~     effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog~     Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS,~     FLS-VAS, healthcare resource consumption, and treatment adherence over time.~   "
63129|NCT02230956|"~     This study will evaluate the efficacy and safety of a single intra-articular injection of 2~     doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee~     osteoarthritis symptoms.~   "
63130|NCT02230943|"~     The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR)~     and allows for a simplified entry process, while establishing a best-in-class resource to~     manage your patient population and improve patient care.~      RISE provides participants with an infrastructure for robust quality improvement activities~     leading to improved patient outcomes, patient population management and quality reporting~     related to rheumatic diseases and drug safety. RISE gives physicians and researchers the~     information they need to optimize patient outcomes, meet reporting requirements, and make~     discoveries that advance rheumatology.~   "
63131|NCT02230930|"~     Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently~     and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced~     skin reactions is poorly understood. Therefore treatment options are limited and suggestive.~      Objective: to investigate the efficacy of four treatments including massage, dilution of~     apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous~     administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin~     reactions.~   "
63132|NCT02230917|"~     Lytic bone disease continues to be one of the most devastating complications of multiple~     myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions~     persist and can continue to significantly impact a patient's morbidity, even when an~     individual's myeloma is otherwise under good control. To date, no agent has been shown to~     have a prolonged bone anabolic response in myeloma.~      Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept~     demonstrated a rapid and sustained increase in serum biochemical markers of bone formation~     and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept,~     RAP-011, increases bone mineral density and strength in murine studies of both normal~     animals and models of bone loss. We hypothesize that sotatercept will provide an anabolic~     response for bone in myeloma patients with bone disease.~   "
63133|NCT02230904|"~     The primary objective of the study is to compare the adhesiveness of 2 different patch~     formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption~     that both patch formulations show similar adhesiveness properties.~   "
63134|NCT02230891|"~     Despite advances in cardiovascular care, the occurrence of heart failure (HF) is steadily~     increasing. The increase in HF rates poses enormous challenges, as once an individual~     becomes symptomatic or requires hospitalization with HF, the prognosis remains poor.~     Therefore, prevention of HF is essential. HF prevention is a critical issue as HF risk~     factors that include common medical conditions such as hypertension and diabetes are also~     increasing. However, not everyone with these risk factors develops HF. Using novel blood~     tests, the investigators propose to identify and treat subjects at higher HF risk to see if~     the investigators can stabilize or improve ultrasound measures known to be associated with~     HF risk. This study will enroll only Veterans.~   "
63135|NCT02230878|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the~     study of the way a drug enters and leaves the blood and tissues over time),~     dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how~     drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female~     participants.~   "
63136|NCT02230865|"~     Pain is an expected part of surgical recovery but effective pain management remains~     challenging. The high variability in postoperative pain experience and analgesic treatment~     response between patients is part of the challenge. Few studies have yet combined~     preoperative assessment of responses to experimental pain with measurements of cognitive and~     emotional processes in the prediction of postoperative pain.~      We hypothesize, that preoperative evoked brain potentials (using standard~     electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned~     pain modulation), responses to pressure/thermal pain stimulation, and/or situational~     pain-related catastrophic thinking are useful clinical predictors of postoperative pain and~     analgesic consumption.~   "
63137|NCT02230852|"~     The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of~     acute stroke. The study is designed as a prospective monocentric observational trial on the~     safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion~     of acute stroke during transportation by the Paramedic Intervention Team of the Universitair~     Ziekenhuis Brussel.~   "
63138|NCT02230839|"~     The purpose of this study is to provide information regarding potential factors underlying~     metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.~   "
63139|NCT02230826|"~     This long-term outcomes study is designed to collect safety and efficacy data on designated,~     commercially available, Tornier hip arthroplasty products.~   "
63152|NCT02230657|"~     The purpose of this study is to identify differences in satisfaction, pain and length of~     stay between patients undergoing hip replacement who are discharged from the hospital on the~     day of surgery compared to patients who stay one night in the hospital.~   "
71397|NCT02122809|"~     The purpose of this dose-escalation study is to assess the safety and tolerability of~     treatment with Chiauranib administered orally over a range of doses in patients with~     advanced solid tumors.~   "
63140|NCT02230813|"~     The term cellulitis is a medical term describing a bacterial infection of the skin and~     tissues beneath the skin. Although it is usually easily treated with antibiotics given~     either orally or through a vein (intravenously), knowing which route of antibiotic treatment~     to prescribe to a person attending an Emergency Department with cellulitis is not clear.~      A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research~     as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which~     patients require oral and which patients require intravenous antibiotics for cellulitis from~     their first visit to an emergency department. The aim of this is to provide safer care by~     reducing the risk of a patient returning to the hospital with a worsening infection. It will~     also promote more cost-effective care by reducing hospital re-attendance rates and wasted~     antibiotics.~      Patients attending the department with cellulitis who are suitable for oral antibiotic~     treatment will be enrolled into this study. A separate doctor will re-examine at least 10%~     of study participants in order to reduce bias. A set of physical signs and symptoms will be~     recorded from each patient in order to determine which ones are associated with them~     failing prescribed oral treatment. A study investigator will then phone the patient after~     14 days to see whether they are better or whether they required intravenous antibiotics to~     get better.~   "
63141|NCT02230800|"~     Side effects are common after treatment with radiotherapy for tumours in the pelvis and can~     affect the way the bowel and urinary system work as well as causing sexual difficulties,~     skin damage and bone problems. Problems in the bowel, bladder, sexual organs and skin mostly~     result from thickening of the tissues in response to radiotherapy, a process called~     fibrosis. Fibrosis often worsens over time.~      There has been progress in treating bowel symptoms which usually are the worst problem after~     radiotherapy. However, even after receiving the best possible treatments, while many~     patients are better, they are often not cured of all their difficult problems.~      For some years, it has been hypothesised that if fibrosis could be treated then symptoms~     would improve. Recent research in laboratory animals has suggested that an effective~     treatment for radiation-induced fibrosis is combination therapy with a drug called~     Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid~     SupraBio), a substance derived from palm oil. Both of these agents are simple to take and~     side effects are rare.~      This study will recruit volunteers who continue to have difficult side effects after~     previous radiotherapy to the pelvis despite receiving the best treatments available from a~     unique clinic at The Royal Marsden which has pioneered treatment for bowel problems after~     radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to~     treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive~     dummy pills. Neither the patients nor the staff assessing them will know which treatment~     they have been given. Volunteers take the active treatments or dummy tablets for a year and~     will be assessed regularly while on treatment and for a year afterwards. This study will~     show whether active treatment is more effective than dummy pills in improving the symptoms~     caused by radiation-induced fibrosis.~   "
63142|NCT02230787|"~     Enamel matrix proteins have been shown to play a crucial role during tooth development and~     its supporting tissues. This is used in periodontal surgery where regeneration of lost~     tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains~     these matrix proteins and has been successfully used in regenerative periodontal surgery for~     more than 16 years.~      The treatment of gum recession is a common requirement, more and more patients are seeking~     treatment at the investigators' clinic due to aesthetic concern, root sensitivity and~     difficulties in performing adequate oral hygiene. The standard treatment comprises the~     transplantation of a piece of connective tissue from the palate to the denuded root surface.~     In many cases Emdogain is additionally applied to enhance healing. So far the effect of~     Emdogain on the early wound healing process after surgical root coverage has not been~     investigated.~      The purpose of the investigators' study is to compare early wound healing parameters between~     treatment with and without Emdogain. For this study 40 patients undergoing root coverage~     surgery at the investigators' department will be included. Early wound healing features~     between the two groups will be described and compared. Furthermore, inflammatory markers~     typical for early healing will be evaluated together with patients`subjective postoperative~     comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators'~     hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative~     complication rates.~   "
63143|NCT02230774|"~     The main purpose of this study is to assess and compare the hydration status of medical and~     nursing staff and to investigate the relationship between the hydration status, cognitive~     function and serum cortisol (marker of stress).~      We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the~     end of their working day. Some, as in other occupations, may be dehydrated at the start of~     their working day. This is likely to be associated with impairment in cognitive performance~     at the end of the working day compared to the beginning and expected to be more pronounced~     after a night shift. There may be less noticeable difference amongst nursing staff given the~     protected break time. Dehydration and associated impairment in cognition is of important~     clinical value as it can impact patient care. participants will be involved in the study for~     two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as~     15 medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15~     day and 15 night shifts from each group). Those that do not work both day and night shifts~     will participate for only one shift and a new participant will be recruited until target~     number of shifts is achieved.~   "
63144|NCT02230761|"~     This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids~     for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe~     steatoblepharon (excess eyelid fat).~   "
63145|NCT02230748|"~     -  Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice~        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put~          for patients with atrial fibrillation?~        -  Safety: How save is the implantation of LAA-Occluders?~        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical~          practice?~        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with~          LAA-Occluder?~   "
63146|NCT02230735|"~     Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral~     ligaments experience less pain postoperatively, need less narcotic pain medication and~     return to activities of daily living sooner.~   "
63147|NCT02230722|"~     The investigators propose to develop a novel intervention that targets the system~     (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran~     (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid~     pain management alternatives.~   "
63148|NCT02230709|"~     The aim of this study is to determinate the effects of percutaneous electrical nerve~     stimulation in the short-term for pain in patients with myofascial chronic neck pain.~   "
63153|NCT02230644|"~     Over 4.6 million operations are undertaken each year in England alone. Of these, many~     patients experience psychological distress, which has negative implications for patient~     recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger~     and distress, has been linked with slower wound healing (Broadbent et al., 2003) and more~     complicated post-operative recovery (Johnston and Wallace, 1990).~      However, pre-operative psychological interventions can have significant positive effects on~     components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988).~     In particular, music has been studied in a series of randomised control trials as a way of~     reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of~     stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and~     blood pressure, and have also found music to be more effective than benzodiazepine at~     reducing pre-surgical anxiety (Bringman et al., 2009).~      Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital,~     performing over 15,000 adult operations annually. Consequently, strategies to reduce patient~     anxiety and improve experience are amongst the hospital's priorities. A renovation of the~     Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and~     music in waiting booths to relax and distract patients. When asked how relaxing they found~     the space, patients at Chelsea and Westminster Hospital involved in a public consultation~     rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing~     music would help them feel less anxious. This project will test whether music and art in the~     SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with~     a view to extending the arts interventions to other surgical waiting areas such as the day~     treatment centre if there are significant positive findings.~   "
63154|NCT02230631|"~     This survey is conducted in South America. The aim of this survey is to investigate~     hypoglycaemia among Insulin-treated patients with diabetes.~   "
63155|NCT02230618|"~     This study is conducted in Asia. The aim of this study is to evaluate long term safety and~     efficacy in patients with diabetes mellitus in routine clinical practice in India.~   "
63156|NCT02230605|"~     Many individuals experience an acute change in thinking and reasoning skills after surgery.~     This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after~     surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study~     is to determine if performing mental exercise, before surgery, will help reduce post-surgery~     memory and thinking problems. A total of 268 patients will be recruited for this study.~      At least 10 days before surgery, subjects complete a series of questionnaires to assess~     baseline cognition level (or thinking ability) and status of overall well-being. At the~     completion of the screening visit, qualifying subjects are randomized into two groups:~      Participants randomized into the Cognitive Exercise group are expected to complete~     tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet~     for the duration of the preoperative period. Participants in this group are expected to~     achieve 1 hour of mental training each day for at least 10 consecutive days prior to~     surgery.~      Participants randomized into the Normal Activity group are encouraged to carry out their~     baseline daily activities, and do not have any study-related cognitive exercise expectations~     before surgery. These subjects still complete the same questionnaires and assessments as the~     Cognitive Exercise group throughout the study, however, are asked not to alter their normal~     daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are~     not permitted to subscribe to Lumosity while in the research study.~      On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is~     taken before surgery. During surgery, research personnel monitor vital signs and medications~     given. After surgery, another CAM evaluation is taken in the post-operative recovery room.~      Throughout the subject's hospital stay, pain levels and medication usage are recorded. The~     CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine~     severity of PD. The evaluations are given twice daily, at approximately 6:00 AM and 6:00 PM,~     for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of~     Recovery Scale (PQRS) is used each post-operative day at 6:00 PM until discharge, and~     completed over the phone on POD 7 if patient discharged. The PQRS is also administered over~     the phone on POD 30 and POD 90.~   "
63157|NCT02230592|"~     Objective:~      Metabotropic glutamate receptors (mGluRs) are G-protein coupled receptors that respond to~     glutamate by activating proteins inside nerve cells that affect cell metabolism, thereby~     fine-tuning the signals sent between cells to maintain balance in neuronal activity. mGluR~     subtype 1 (mGluR1s) are located in several brain regions, including the cerebellum,~     hippocampus, olfactory bulb, and basal ganglia. mGluR1 activation stimulates phospholipase~     C, resulting in phosphoinositide hydrolysis and increased intracellular calcium levels.~     Successful development of a positron emission tomography (PET) ligand to image mGlurR1 would~     impact clinical management of brain disorders characterized by disruptions in glutamatergic~     transmission, including anxiety and stress disorders, drug addiction, epilepsy, Huntington s~     disease, and Parkinson s disease. However, detailed study of mGluR1s has heretofore been~     hindered by the lack of high affinity and selective ligands for this receptor subtype.~      The present protocol will evaluate the ability of a new PET ligand, [18F]FIMX, to image and~     quantify mGluR1 in the brain of healthy human volunteers. This protocol covers four phases:~        1. Phase 0: screening whole-body scan;~        2. Phase 1: kinetic brain imaging to quantify mGluR1 in brain relative to concurrent~          measurement of the parent radioligand in arterial plasma;~        3. Phase 2: if the tracer is successful in Phase 1, we will estimate radiation-absorbed~          doses of [18F]FIMX by performing whole body imaging;~        4. Phase 3: test-retest analysis of brain binding relative to concurrent measurement of~          the parent radioligand in arterial plasma.~      Study Population:~      Healthy adult female and male volunteers (n=22, ages 18 to 55) will undergo brain or~     whole-body imaging..~      Design:~      This study will begin with a screening whole-body scan to confirm that the radioactivity has~     fairly broad distribution in several organs. For absolute quantification of mGluR1, 22~     healthy controls will have brain PET imaging using [18F]FIMX and an arterial line. Up to 12~     of them will have a test-retest scan. Eight additional subjects will have a whole body PET~     scan for dosimetry, which does not require an arterial line.~      <TAB>~      Outcome Measures~      To assess absolute quantitation of mGluR1 with [18F]FIMX, we will primarily use two outcome~     measures: the identifiability and time stability of distribution volume calculated with~     compartmental modeling. In test-retest study, we will calculate the retest variability. To~     assess whole-body biodistribution and dosimetry of [18F]FIMX we will use the organ~     time-activity curves.~   "
63158|NCT02230579|"~     This is a first-in-human study of MMV390048. The study will evaluate the safety,~     tolerability and pharmacokinetic properties of escalating single and multiple doses of~     MMV390048 when administered to healthy male volunteers and female volunteers of~     non-childbearing potential.~      In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will~     be investigated.~   "
63159|NCT02230566|"~     The Phase 3 study will use a novel randomized, intra-subject placebo-controlled, single~     crossover design, referred to as Blind Start, to evaluate the safety and efficacy of UX003.~   "
63160|NCT02230553|"~     This is an open-label phase I/II multi-center study consisting of two parts. Part A of this~     study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with~     trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt), CRC, NSCLC, or~     pancreatic cancer. Part B is designed to perform a randomized comparison of the~     lapatinib-trametinib combination versus standard of care therapy in patients with metastatic~     KRASm/PIK3CAwt CRC, NSCLC or pancreatic cancer.~   "
63161|NCT02230540|"~     The aim of this investigation is to study how the position of different catheters affect~     drainage of the bladder.~   "
63162|NCT02230527|"~     This is a single center, prospective, randomized, unblinded, open-label, active controlled~     pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus~     clopidogrel plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone~     a percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.~   "
63163|NCT02230514|"~     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures~     (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac~     crest.~      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded~     autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia~     (Blood and Tissue Bank of Catalonia).~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration up to consolidation of non-union fractures.~   "
63164|NCT02230501|"~     Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT~     01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin~     demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE~     insulin/day. The aim of the present study was to investigate in a randomized-controlled~     trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication~     or insulin.~   "
63165|NCT02230488|"~     The purpose of this study is to assess whether intensive case management interventions by a~     diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31~     day readmission in previously identified high risk patients with diabetes.The procedures of~     the study will focus on managing the patient's diabetes and diabetes education while in the~     hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital,~     and assist in the patient's diabetes management plan for a safe discharge.~   "
63166|NCT02230475|"~     This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic~     rhinitis symptoms in participants under controlled conditions, to collect well-characterized~     biological samples (urine and blood) before and after they develop these symptoms. The EEU~     provides the ability to control the timing, duration and levels of allergen exposure, and~     also other outside environmental factors, yielding ideal biologic samples for analysis with~     novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic~     rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance~     analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on~     blood samples and compared to spin prick testing and symptoms of allergic rhinitis.~   "
63167|NCT02230462|"~     The purpose of this study is to assess the effects of visualization of skin cancer resection~     defects on the face on the post-operative satisfaction of patients after their~     reconstruction. To achieve this aim, patients invited to participate in this study will be~     randomized to either seeing or not seeing their skin cancer excision defect prior to~     reconstruction. After reconstruction, patient satisfaction will be assessed in both groups~     to determine if visualization of the defect prior to reconstruction has any effect on~     patient satisfaction and if any detected effect has durability over time.~   "
63168|NCT02230449|"~     The aim of the study is to analyze the expression of genes and microRNAs potentially~     involved in oocyte competence in follicles of different sizes (<17mm and ≥17mm) at the time~     of oocyte pick-up.~   "
63169|NCT02230436|"~     The aim of this study is to demonstrate the hypothesis that early removal of drain can~     reduce the incidence of intra-abdominal infection and pancreatic fistula after~     pancreatectomy compared with later removal of drain.~   "
63170|NCT02230423|"~     This study investigates wether patients with increased trigeminal perception threshold and~     low expression of TRP channels have more often nasal blockage despite functionally~     successful nasal surgery (TRP channel = transient receptor potential channel).~   "
63171|NCT02230410|"~     To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro~     ablation .~   "
63172|NCT02230397|"~     Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the~     revitalizing activity of a face cream applied twice a day, morning and evening, for an~     uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face~     ritidosis and women aged 55-65 years not habitual user of antiage-creams.~      The study foresaw the comparison within subjects of the study product versus placebo (half~     face method).~      It was also aim of this study to evaluate products efficacy and cosmetic acceptability by~     the volunteers and tolerance both by investigator and volunteers.~   "
63173|NCT02230384|"~     The investigators will evaluate effects of a novel drug that improves nicotinergic receptor~     function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have~     a high interest in quitting. The investigators predict that the novel drug will increase~     days of abstinence, compared with placebo, identifying potential evidence of efficacy for~     smoking cessation in smokers with schizophrenia.~      The investigators will also assess if this new drug decreases nicotine withdrawal, craving,~     and cognitive impairment during early abstinence, as well as evaluate adverse effects.~   "
63174|NCT02230371|"~     The aim of this study is to to investigate if local treatment with intramuscular injections~     of granisetron are effective in alleviating pain in patients with chronic myofascial pain in~     the orofacial muscles~      The study hypothesis is that local administration of granisetron reduces pain and~     allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and~     that this effect of granisetron on pain is larger than the effect from placebo~   "
63175|NCT02230358|"~     The aim of this study is to investigate the differences between the cardiac output and the~     cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a~     randomized, controlled, single center study at the Medical University Innsbruck, Department~     of Anesthesia and Intensive Care Medicine.~   "
63176|NCT02230345|"~     The important role played by the GI tract microflora on the metabolic health of an~     individual are increasingly recognized. In this respect, the initial studies of Metchinkoff~     that suggested a role of fermented food (specifically yoghourts ) to modulate the gut~     microflora have evolved into the concept of probiotics. Probiotics are living~     microorganisms that bring a benefit to the host when administered in sufficient quantity~     (WHO/FAO, 2001).~      Here the investigators will study, in normal young male volunteers, the potential to~     modulate post-prandial metabolic and inflammatory responses by the administration of a~     yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).~   "
63177|NCT02230332|"~     Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against~     stimuli that produce bronchoconstriction. The combination of long-acting beta agonists~     (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller~     medication class in the United States, but unfortunately, even when LABAs are added to ICS~     and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular~     use of beta-agonists, both short and long-acting, reduces the ability of these agents to~     protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor~     stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of~     concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic~     receptor internalization, can reduce the loss of bronchoprotection that occurs with regular~     use of LABAs, even when used in combination with ICS.~   "
63181|NCT02230280|"~     Most stroke survivors live with other chronic health conditions that can negatively affect~     their recovery and overall health and well-being. Although stroke care has improved, there~     are still many challenges to the delivery of community-based stroke care. These challenges~     include: poor coordination of care across health care providers and settings; limited~     communication among health care providers; limited use of evidence-based treatment~     guidelines; difficulties navigating community services and supports; and limited client and~     family caregiver involvement in making healthcare decisions. The investigators developed a~     new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges~     to improve the overall quality of stroke care at home. This study will expand this work to:~     1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact~     and usability for home care providers, stroke survivors, and their family caregivers, and 3)~     determine its impact on the costs of use of health services.~   "
63182|NCT02230267|"~     Several animal and human epidemiologic studies have provided evidence that exercise may be~     neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the~     case of those who have already been diagnosed with PD, it may slow the observed~     neurodegeneration. Unfortunately, because this line of research is in early stages, there is~     little evidence to indicate what biological mechanisms underlie the neuroprotection that is~     conferred with exercise. Toward this end, it is possible that an interaction between~     endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be~     associated with exercise improvements in PD.~      One of the most common reasons for premature death in PD is falls. Several meta-analyses~     have concluded that exercise training programs focused on balance and/or strength training~     are effective at improving aspects of balance. Taken together, the current body of evidence~     suggests that exercise may be neuroprotective and balance/strength training may decrease the~     likelihood of a fall. The combination of these efficacious treatment modalities (exercise~     and balance/strength training) in a comprehensive treatment approach to improve PD symptoms~     and balance has been previously reported at relatively mild or moderate exercise~     intensities. Because recent research has suggested that patients with PD may benefit more~     from more physically intense programs, we are proposing a more aggressive approach with~     regard to exercise intensity and frequency in the present trial. The primary purpose of this~     study is to determine the feasibility and safety of a high intensity exercise approach to~     PD. A secondary purpose is to determine the trajectory of change in outcomes over the~     duration of the trial from a high intensity fall prevention program. It is hoped that a~     signal of efficacy will allow this trial to progress to a comparative effectiveness trial.~     An important innovative design element is collecting biological assays to better understand~     the mechanism underlying the anticipated clinical improvements.~      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp~     (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers~     for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;~     strengthening at least two times per week) for the duration of the trial. Aim 2 is to~     determine if participation in an 8-week HIBC under the direction of a physical therapist is~     safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week~     HIBC will produce a signal of efficacy for several physical outcomes: falls per physical~     activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,~     cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an~     8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory~     cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of~     BDNF val66val, val66met, met66met polymorphisms to determine if there is a differential~     response to exercise.~      This trial is innovative because it utilizes a high intensity comprehensive exercise~     treatment approach (aerobic exercise, strengthening, and balance training). To our~     knowledge, there have been no trials of individuals with PD who have participated in a trial~     of this intensity in a group boot camp setting. Another innovative design element is the~     use of three novel assessments: biological assays of pro- and anti-inflammatory cytokines,~     endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity~     ratio).~      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual~     care control group (standard, low intensity group therapy class) under the direction of~     physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist~     ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be~     required to attend 3 out of the 5 days. The protocol of the HIBC will include the following~     exercise components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15~     minutes of strengthening the major muscle groups; C. 15 minutes of balance training; and, D.~     15 minutes of interspersed rest and stretching. Participants will rotate through these four~     exercise components. Participants will have one baseline test and assessments at the 2-week,~     4 week, 8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be~     frequency counts of participation, adverse events, and compliance with exercise. The~     outcomes for the secondary aims will include measures of balance and falls, physical~     capacity, fatigue, exercise/physical activity behavior, and biological assays.~   "
63183|NCT02230254|"~     PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM~     Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of~     Atherosclerotic Lesion(s)~   "
63184|NCT02230241|"~     This is a multi-center survey of patients who are currently receiving lipid-lowering~     medications and have a moderate or higher cardiovascular (CV) risk. The survey will be~     conducted in the Russian Federation. Data collection for each study subject will be done~     within one physician visit. If an enrolled subject comes to the visit not fasting (for at~     least 8 hours), an appointment for the blood tests will be made for another day.~   "
63185|NCT02230228|"~     This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of~     ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.~   "
63186|NCT02230215|"~     This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging~     to determine whether patient-specific instrumentation for total knee arthroplasty~     (replacement) has an effect on implant loosening compared to conventional instrumentation.~     Secondary objectives will include assessment of post-operative implant alignment, patient~     satisfaction, operative time and surgical instrument use, cost, and environmental impact.~   "
63187|NCT02230202|"~     The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment~     with calcineurin inhibitors (CNIs) are each associated with the release of endothelial~     microparticles into the plasma.~   "
63188|NCT02230189|"~     This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs)~     that are differentially expressed in the airway epithelium of patients with asthma at~     baseline and in response to allergen challenge. We hypothesize that allergen exposure~     enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a~     consequence of locally increased T-cell derived cytokine production. The study will involve~     three visits over the course of approximately 14 days. At Visit 1, participants will be~     characterized in detail with lung function testing, methacholine challenge testing, and~     allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with~     segmental allergen administration of either cat or dust mite standardized allergen extract.~     At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to~     collect airway samples including bronchoalveolar lavage (BAL), epithelial brushings and~     endobronchial biopsies. Sample analysis will include measurement of miRNA and mRNA~     expression in epithelial brushings (RNAseq and qPCR); analysis of cell surface markers on~     BAL cells and blood cells; and collection of endobronchial biopsies for immunostaining of~     immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis~     of mucin content and smooth muscle cell subculture. A total of 38 subjects (26 asthmatics~     with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic~     non-asthmatics) will complete the study.~   "
63189|NCT02230176|"~     This study is the first randomized, open-label, national, multicenter, phase II study~     assessing the efficacy and safety of OCLU in subjects with pretreated progressive~     pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic~     neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of~     disease within 1 year prior to the start of the study. The control group of patients~     receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS~     equal to 35% in patients receiving Sutent.~   "
63190|NCT02230163|"~     Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first~     time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several~     other Caribbean islands as well as French Guyana, South America. During the outbreak of~     Chikungunya that affected the Reunion island in 2005/2006, it was observed that the neonatal~     forms of infections acquired by mother to child transmission during childbirth, were not the~     exception and were critical. Mother-to-child transmission occurs when the mother is viremic~     at the time of delivery. The mean duration of viremia after the onset of first clinical~     symptoms is six days. The rate of mother-to-child transmission is 50%. All neonates~     contaminated during labor and delivery present with a symptomatic disease and the rate of~     severe forms is about 50%, primarily due to damage of the central nervous system, often~     leaving permanent damage (seizures, cerebral palsy).Due to the severity of Chikungunya in~     neonates and the burden of cerebral palsy, it is imperative to identify a safe and effective~     preventive and/or curative intervention. Human polyvalent immunoglobulins purified from~     plasma samples obtained from Chikungunya-convalescent donors exhibit a potent neutralizing~     activity in vitro. They were evaluated for their preventive and curative effects in a~     neonatal mouse model of CHIKV infection. After administration of a lethal dose of CHIKV, all~     neonatal mice that had received immunoglobulins survived while all control animals that had~     received non hyperimmune immunoglobulins died. In humans, specific human immunoglobulins~     proved to be effective and safe in neonates born to hepatitis B viremic mothers.~      Hypothesis : The investigators hypothesize that the administration of anti-CHIKV hyperimmune~     human intravenous immunoglobulins to neonates exposed to a high risk of severe form of~     Chikungunya infection is safe enough to justify its evaluation in an open non randomized~     trial aimed to confirm the safety and preliminary assess the efficacy of this intervention.~   "
63191|NCT02230150|"~     The purpose of this study is to verify the impact of the educational intervention in the~     adhesion to therapeutic strategies for patients with heart failure.~   "
63192|NCT02230137|"~     The purpose of this study is to assess HbA1c reduction after supportive care by SMS among~     adolescents with poorly controlled type 1 diabetes.~   "
63193|NCT02230124|"~     The purpose of this project is to assess the utility of a new magnetic resonance technique~     called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal~     pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging~     signature for hydrocephalus that distinguishes the disease from the normal~     (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR~     imaging studies that are presently available.~   "
63194|NCT02230111|"~     The purpose of this study is to measure the effects of a reduced-calorie low energy density~     diet with and without increased cognitive dietary restraint (CDR) on stress (biological~     markers and perceived stress), eating behaviours, appetite sensations, anthropometric~     variables and women's attitude toward their children's eating behaviours in premenopausal~     overweight/obese women in both the short term (immediately after the end of the 4-week~     intervention) and longer term (3 months after the end of the intervention). The~     investigators hypothesize that cortisol concentrations are higher, appetite sensations are~     increased (i.e. increased global appetite score) and food cravings are more prevalent in~     women of the energy-restriction-plus-CDR group than in women of the~     energy-restriction-without-CDR group after the 4-week intervention. They also hypothesize~     that perceived stress is higher and food cravings are more prevalent in women of the~     energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group~     at 3-month post intervention. They hypothesize that no significant difference in body weight~     changes is observed between the two groups and that maternal restriction of their child's~     eating is higher in the energy-restriction-plus-CDR group than in the~     energy-restriction-without-CDR group both after the 4-week intervention and at the 3-month~     follow-up.~   "
63195|NCT02230098|"~     Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart~     disease accounts for the bulk of it. The purpose of this study is to clarify whether a~     mechanical method of remote ischemic conditioning in the form of short-term obstruction of~     the blood supply to the arm, can improve the heart's blood supply in patients with ischemic~     heart disease. This will be attempted through experiments on patients with ischemic heart~     disease and experimental animal studies with simulated cardiovascular disease.~      This study will help to clarify whether remote ischemic preconditioning can be used to treat~     patients with ischemic heart disease.~   "
63196|NCT02230085|"~     While continuous positive airway pressure (CPAP) is the gold standard treatment of~     obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The~     adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.~     The data collected from this trail allows for closer monitoring of at-risk patients. For the~     study, participants are provided with a questionnaire prior to starting CPAP therapy for~     OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem~     to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21,~     30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study~     the GSM unit is returned, and participants continue with CPAP therapy as instructed by their~     healthcare provider.~   "
63197|NCT02230072|"~     The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique~     for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.~      The investigators hypothesis is that this minimally invasive technique is feasible, and that~     this approach will have the same efficacy as open fetal surgery for MMC, but with~     significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery.~     The fetus will have a repaired MMC defect, and the mother will not have a uterine incision~     (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all~     subsequent deliveries are by cesarean section. There may also be a decreased risk of~     Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the~     current open operation. Finally, a vaginal delivery is possible following the fetoscopic~     fetal surgery if the baby is shown to have a skin covered repair.~   "
63198|NCT02230059|"~     The purpose of this study is to assess the treatment patterns in participants with~     metastatic castration-resistant prostate cancer (mCRPC). Additionally, participant's~     demographic and clinical characteristics, skeletal-related events, criteria used to define~     CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall~     survival will be observed.~   "
63199|NCT02230046|"~     The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic~     parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current~     commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or~     drinking) conditions in healthy male participants.~   "
63200|NCT02230033|"~     The purpose of this study is to assess the effect of multiple doses of itraconazole or~     gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood~     and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021)~     in healthy male participants.~   "
63201|NCT02230020|"~     Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand~     during sleep. The central hypothesis of this proposal is that lowering ventilatory demand~     using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on~     exertion and improve quality of life. Thus, this proposal aims will determine the effects~     HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.~   "
63202|NCT02230007|"~     The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population~     of elderly patients, the therapeutic resources to control the passing pain require in their~     manipulation a certain caution and are not divested of side effects badly tolerated at this~     age. An alternative in the opioid presents all its interest. The MEOPA is here an~     alternative of choice in the care of these pains, in particular in case of pre-existent~     cognitive achievement, of polypathologies or of polymédication.~      The gas MEOPA administered to the mask could thus be an effective additive in the~     physiotherapy treatment of the elderly person.~      The main objective is to Assess the efficacy , in terms of recovery of the hip and knee~     joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard~     reeducation within a population of elderly patients presenting a pain during the~     physiotherapy treatment.~   "
63203|NCT02229994|"~     The purpose of this study is the psychometric validation of a self-administered dyspnea~     questionnaire, usable in clinical practice in order to assess dyspnea and its impact on~     patients with chronic respiratory diseases.~   "
63204|NCT02229981|"~     The investigators are conducting sequential Phase 1 and IIa trials to identify the maximum~     tolerated dose and to evaluate safety, tolerability, toxicity, pharmacokinetics and~     pharmacodynamics of the oral anti-cancer agent ABC294640 specifically in patients with~     diffuse large B-cell lymphoma, including patients with virus-induced (e.g., KSHV- or~     EBV-associated) lymphoma.~   "
63205|NCT02229968|"~     The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective~     in reducing blood loss in children undergoing craniofacial reconstruction surgery.~      The investigators hypothesize that Amicar will decrease intraoperative blood loss and~     decrease the need for perioperative blood product administration in children undergoing~     craniofacial surgery.~   "
63206|NCT02229955|"~     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic~     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12~     weeks after treatment, each treatment group comparisons for evaluation of efficacy and~     safety in Moderate to Severe Dry Eye Disease.~      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),~     Non-anesthetic Schirmer test~   "
63207|NCT02229942|"~     The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic~     Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from~     B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and~     maintenance treatment.~   "
63208|NCT02229929|"~     The primary purpose of this study is to:~        -  Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one~          week in patients who are undergoing hemodialysis. (Part A)~        -  This study is also investigating whether repeated doses of IV CR845 over two weeks is~          safe and effective in reducing the intensity of itching in hemodialysis patients with~          uremic pruritus (Part B).~   "
63209|NCT02229916|"~     The majority of testicular cancer patients can be cured with cisplatin-based chemotherapy.~     Mortality has been reduced even more within the last 15 years due to the stringent~     application of standard chemotherapy followed by resection of residual disease. This is a~     positive development considering that testicular cancer usually affects young men. Active~     surveillance has become an acceptable and widely used strategy in stage I testicular cancer.~     Thus, it is important to follow these patients in a standardized way and to adhere to a~     rationale surveillance strategy. There is no international consensus regarding follow-up of~     testicular cancer patients. Stratification according to risks and patterns of relapse would~     allow to tailor follow-up schedules, aiming at early identification of relapse without~     causing unnecessary harm by using excessive radiation in these young long-term survivors.~     Follow-up procedures should not only aim at detecting relapse, but also long-term side~     effects from therapy, including hypogonadism, metabolic syndrome, cardiovascular disease and~     secondary malignancies. The Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS)~     will comprise consecutive newly diagnosed testicular cancer patients and is the first study~     to prospectively evaluate the initial indictor of relapse in testicular cancer patients, the~     frequency and pattern of relapse and document long-term toxicities of the treatment~     (cardiovascular, gonadal, hearing impairment, renal function and second malignancies) and~     psychosocial aspects. This cohort study will determine the relevance of each test performed~     routinely during follow-up. The collected data will have direct implications for the care of~     patients with testicular cancer and inform future adaptations of follow-up recommendations.~     The dataset will give information on baseline factors of testicular cancer patients~     patients, current treatment strategies in Switzerland, Austria and Germany, outcome and late~     sequelae.~   "
63210|NCT02229903|"~     The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)~     treatment in subjects with OCD. The device technology is based on the application of deep~     brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway~     DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS~     treatment to sham treatment.~   "
63211|NCT02229890|"~     Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen~     Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute~     ischemic stroke~   "
63212|NCT02229877|"~     The purpose of this study is to: determine the effect of stomach pH on the multiple dose~     pharmacokinetics (PK) of AF-219; assess the effect of multiple doses of AF-219 on various~     sensory assessments; and, assess the safety and tolerability of AF-219.~   "
63213|NCT02229864|"~     The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling~     approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB~     III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus~     delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only~     receive Absorb BVS with a maximum of two de novo native coronary artery lesions after~     implantation of the Absorb BVS.~      Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III~     RCT primary endpoint.~   "
63214|NCT02229851|"~     This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly~     dosing of NNC0195-0092 compared to placebo and once-daily dosing of somatropin (human growth~     hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.~   "
63215|NCT02229838|"~     Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464~     p.o once daily in a rising dose group-comparison (placebo controlled, double blind,~     randomized per dose level).~      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual~     comparison), preliminary assessment of food effects (interindividual comparison)~      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and~     Subsequent Randomised, Open Parallel Group Phase).~      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative~     Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial~     Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent~     Randomised, Open Parallel Group Phase).~   "
63216|NCT02229825|"~     Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized~     for severe depression after 4 weeks of treatment. To evaluate the rescue option in~     non-responding patients. Safety of Duloxetine will also be assessed.~   "
63217|NCT02229812|"~     Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom~     onset in acute ischemic stroke patients~   "
63218|NCT02229799|"~     The objectives of this study are to review the safety and efficacy of Actilyse Vial~     (hereafter referred to as Actilyse) in post-marketing use for treatment of acute ischemic~     stroke, through investigating followings;~        1. Unknown adverse events (especially serious adverse events)~        2. Frequency (Incidence) and trend of adverse events under the actual practice~        3. Factors on the safety profile of Actilyse~        4. Factors on the efficacy profile of Actilyse~   "
63219|NCT02229786|"~     Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,~     and placebo in patients with painful gastric or intestinal spasms.~   "
63220|NCT02229773|"~     Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene~     cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary~     pharmacokinetics~   "
63222|NCT02229747|"~     The objective of this study was to assess the clinical efficacy and safety of meloxicam~     suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day~     or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients~     with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis~   "
63223|NCT02229734|"~     This study will explore the combination of a stereotactic body radiation therapy (SBRT)~     approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for~     older men with high risk prostate cancer, or men unwilling to undertake conventionally~     fractionated therapy and three years of adjuvant hormone therapy.~      The purpose of this study is to examine the safety of a shorter course of radiation~     treatment combined wtih androgen deprivation therapy.~   "
63224|NCT02229721|"~     The purpose of this study is to determine whether intranasal oxytocin is effective in~     comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal~     women.~   "
63225|NCT02229708|"~     The purpose of this study is to find out whether a technology-base healthy lifestyle program~     is an acceptable and effective way for African-American mothers to improve their eating and~     activity during pregnancy, compared to usual obstetric care. The goal of the program is to~     enhance the health of African-American mothers and their babies.~   "
63226|NCT02229695|"~     This is a prospective comparison trial. Patients that will be included in the trial are~     those that will have operations in which their abdominal closure is temporary, i.e. patients~     sustaining trauma or septic abdomen.~      Patients will be grouped according to the method of temporarily abdominal closure (TAC)~     procedure:~        1. Vacuum-assisted closure (VAC)~        2. Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are~          currently accepted with no clear cut evidence to prefer one on another. At Soroka~          Medical Center the decision to choose either of the methods is at the surgeon's~          discretion.~      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure~     technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure~     done as part of the monitoring processes of critically ill patients in the General Intensive~     Care Unit (GICU).~      Patients will be evaluated for the development of acute intra abdominal hypertension with or~     without abdominal compartment syndrome.~   "
63227|NCT02229682|"~     This study is to make sure whether reduced-dose radiation treatment is sufficient to control~     the disease in patients with early-staged extranodal nasal-type NK/T-cell lymphoma, who have~     got complete remission tumor after chemotherapy in a new and more effective~     asparaginase-based GELOX regimen~   "
63228|NCT02229669|"~     This study compared the clinical outcomes of coronally advanced flap using two different~     surgical strategies in the treatment of multiple gingival recessions.~   "
63229|NCT02229656|"~     Accelerated, normofractionated radiotherapy is the treatment of choice in stage II-III~     laryngeal and oropharyngeal squamous cell carcinoma (SCC). However, twenty to thirty percent~     of patients with stage II-III laryngeal and HPV negative oropharyngeal SCC develop disease~     progression, mainly due to lack of locoregional control. Radiosensitizers such as cisplatin~     and cetuximab are added to radiotherapy in more advanced stage of head and neck (H&N)~     cancer. These radiosensitizers improve loco-regional control and overall survival.~     Unfortunately, as these radiosensitizers, notably cisplatin, also dose intensify the~     radiation dose in normal tissues, they also significantly increase toxicity. Adding a more~     tumor-specific radiosensitizing agent could improve loco-regional control and overall~     survival without significantly increasing toxicity.~      Radiotherapy kills tumor cells by inducing DNA damage. The efficacy of radiotherapy is~     limited by the ability of tumor cells to repair this DNA damage. Poly(ADP-ribose)polymerase~     (PARP) is an essential enzyme in base excision repair and single strand break DNA repair,~     DNA lesions arising from radiation treatment. PARP inhibition and consequently the~     inhibition of PARP-facilitated DNA repair enhances the anti-tumor activity of radiotherapy,~     as shown in preclinical studies including head and neck xenograft studies. This~     radiosensitization is thought to be proliferation dependent and is more pronounced in~     homologous recombination (HR) deficient cells, providing an opportunity for tumor specific~     targeting. Genetic analyses suggest that HR deficiency is commonly found in H&N SCC: ATM~     loss has been reported in 60% of human H&N SCC biopsies and FANC-F defects were reported in~     15-21% of human H&N SCC biopsies and cell lines.~      The efficacy of radiotherapy is also limited by tumor hypoxia, as tumor hypoxia results in~     radioresistance. Some PARP inhibiting compounds increase tumor perfusion in xenograft~     models, thereby reducing hypoxia and specifically sensitizing tumor cells to radiotherapy.~     Hypoxia is commonly found in H&N SCC and a high pre-treatment hypoxic fraction in H&N SCC~     tumors is associated with worse outcome. The high prevalence of both hypoxia and HR~     deficiencies in H&N SCC support the concept of tumor-specific radiosensitization by PARP~     inhibition in head and neck cancer patients.~      Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for HR defected tumors~     and as a dose intensifier for chemo- and radiotherapy. In humans, olaparib has a low~     toxicity profile as a single agent, with increasing bone marrow toxicity when combined with~     chemotherapy. The combination of olaparib and radiotherapy for H&N SCC is expected to~     improve locoregional control and thereby overall survival. However, this combination~     treatment has never been tested in humans before. The purpose of this study is to determine~     the safety and tolerability of radiotherapy for stage II-III laryngeal and stage II-III~     HPV-negative oropharyngeal SCC with concurrent olaparib.~   "
63230|NCT02229643|"~     Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an~     important role in mediating neuroanatomical plasticity and functional recovery following~     traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin~     and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h~     posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma~     Score and prognosis of such patients with traumatic brain injury.~   "
63231|NCT02229630|"~     The purpose of this study is to compare the apparent diffusion coefficient in the frontal~     lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared~     with foetuses with intra-uterine growth restriction and a good neonatal outcome.~   "
63232|NCT02229617|"~     For people who identify as transgender, there is a strong sense that they were born into the~     wrong body and that their outward looking body does not match how they truly feel about~     themselves. They feel male, not female and have always felt that way. There is a great deal~     of discomfort or dysphoria about looking and feeling female, and there is a strong desire to~     achieve a more masculine appearance. While surgery, clothing and hair for example, can help~     a person appear more like a male, many transgender males will want to take testosterone to~     make them feel and look more masculine.~      This usually involves injecting testosterone into a muscle every 1-2 weeks for many years.~     Intramuscular injections can often be uncomfortable or painful, and requires the patient to~     be taught how to inject themselves. Or somebody else has to do it. There is a growing trend~     in some transgender men to give their injection just below the skin or subcutaneously (like~     insulin in a diabetic), because it is less uncomfortable but we don't really know if~     testosterone gets into the blood in the same way. At least one clinic in the US already~     suggests that patients can use the subcutaneous method but there is almost no research to~     show it's the same as intramuscular.~      Our project will be looking at a small group of transgender males who are already on~     intramuscular testosterone and then switch them over to the same dose of subcutaneous~     testosterone, and then compare their levels of testosterone. If those levels are similar,~     then patients may chose the less uncomfortable subcutaneous injection.~   "
63233|NCT02229604|"~     Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes~     dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents~     and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular~     menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone~     (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the~     effect of EA versus other therapies for DOR.~   "
63234|NCT02229591|"~     Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing~     expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation~     and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles~     dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise~     tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis~     is that EFL should affect post operative outcomes like incidence of pulmonary complication~     and length of stay in hospital~   "
63235|NCT02229578|"~     Burn pain is known to be one the most severe forms of acute pain often requiring large~     amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for~     controlling pain in various settings including dressing changes of burns. The aim of this~     study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and~     narcotic requirements when applied to donor graft sites while at the same time not~     interfering with the standard of care TheraBond dressing. During this study the~     investiagtors will be monitoring for evidence of delayed wound healing, and surgical site~     infection.~   "
63236|NCT02229565|"~     The purpose of this study is to further elucidate the molecular mechanisms underlying~     prostate cancer disparities. In previous work the investigators have identified a set of~     differentially deregulated genes in African American versus Caucasian American prostate~     cancer. Based on these findings, they hypothesize that they will be able to validate these~     targets, originally identified in the previous work conducted at The George Washington~     University Medical Center, in an independent Duke University Medical Center cohort of~     prostate cancer specimens. In addition, the investigators hypothesize that they will be able~     to discover novel targets in the Duke University Medical Center cohort of prostate cancer~     specimens because of regional differences.~   "
63237|NCT02229552|"~     The study is designed to assess habituation of behavioral responding for food as risk~     factors for increases in Standardized Body Mass Index (zBMI) over three years in~     non-overweight children.~   "
63238|NCT02229539|"~     The purpose of this study is to test whether a mouthwash made with a drug called doxepin can~     reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth~     rinse preparations exist for patients with treatment-related oral mucositis pain such as the~     DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin~     compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by~     the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term~     pain management, as well as management of rash.~   "
63239|NCT02229526|"~     The initial trial examined if fish oil supplementation during pregnancy could reduce the~     risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth~     in pregnancies that were at increased risk of these complications. The study was designed as~     a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.~   "
63240|NCT02229513|"~     The objective of the study is to demonstrate whether cooling the uterine smooth muscle~     during cesarean section (following delivery of the fetus) will promote better uterine~     contraction and involution resulting in lower blood loss, use of fewer uterotonic~     medications, and fewer hysterectomies following cesarean section. The investigators suspect~     that it may.~   "
63241|NCT02229500|"~     Obesity, with its associated co-morbidities, is a major public health challenge. It is~     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is~     associated with increased risk of developing diabetes, cardiovascular disease, and certain~     cancers. The increasing epidemic of obesity has necessitated the study of the complex~     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are~     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of~     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several~     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been~     shown to play an important role in regulating short-term food intake. Peripheral~     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.~     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to~     nutrient availability in different regions of the gut and provide an exquisite mechanism of~     nutrient sensing in response to dietary intake. These hormones therefore represent potential~     targets in the development of novel anti-obesity treatments. A novel and attractive strategy~     to induce appetite regulation is the enrichment of foods with components that stimulate the~     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial~     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY~     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free~     fatty acid receptors (FFAR) on colonic L cells. Of the SCFAs produced by colonic~     fermentation of dietary fibre, propionate has the highest affinity for FFAR 2. Furthermore,~     propionate is an end product of bacterial metabolism, and thus, unlike acetate, does not~     undergo conversion to other SCFAs. Increasing colonic propionate is therefore an attractive~     target for appetite modulation.~      We have developed a novel delivery system for delivering propionate to the right site in the~     colon and we now wish to optimise the delivery of propionate to the colon in man using~     stable isotope labelling methods.~   "
63242|NCT02229487|"~     Hypothesis~        1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than~          those with normal sleep duration.~        2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to~          a standardized meal~   "
63243|NCT02229474|"~     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger~     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.~      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to~     facilitate diagnosis of, and therapy for, people with dementia led by local communities in~     sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and~     their caregivers.~      Within this trial of CST, we hypothesise that CST can significantly improve the quality of~     people with dementia and their carers living in Africa~   "
63244|NCT02229461|"~     To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory~     effect of a low dose Immediate Release Aspirin (IR ASA) regimen.~   "
63329|NCT02228330|"~     The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg~     jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of~     obturator nerve block in the prevention of inadvertent muscle spasm, and to identify~     predictors for both the jerking reflex and successful nerve block.~   "
63245|NCT02229448|"~     Immunoglobulin G4-related disease (IgG4-RD) is an increasingly recognized syndrome of~     unknown etiology comprised of a collection of disorders that share specific pathologic,~     serologic, and clinical features.~      Histopathological analysis of biopsy specimens remains the cornerstone in the diagnosis of~     IgG4- related disease. Elevated concentrations of IgG4 in tissue and serum are helpful in~     diagnosing IgG4-related disease, but neither one is a specific diagnostic marker.~     Correlation with specific histopathological findings is essential, regardless of the serum~     IgG4 concentration, the number of IgG4-positive plasma cells in tissue, or the ratio of IgG4~     to IgG in tissue. Misdiagnoses of IgG4-related disease are increasingly common because of~     excessive emphasis on moderate elevations of serum IgG4 concentration and overreliance on~     the finding of IgG4-positive plasma cells in tissue.~   "
63246|NCT02229435|"~     Statement:~      Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate~     (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula~     and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo~     nephrological and urological care (diagnosis and treatment) to prevent chronic kidney~     failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes~     Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European~     Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD.~     Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD~     should be treated and the medical care should be optimized.~      Hypothesis:~      Not all patients with CKD receive urological and nephrological care. Interdisciplinary work~     of outpatient working urologists and nephrologists in the metropolitan area Magdeburg /~     Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment~     connection of CKD patients for an orientating statement is needed.~   "
63247|NCT02229422|"~     We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will~     induce similar if not higher response rates than the ones observed in Rituximab plus HDMP~     studies (Castro et al., 2009, Castro et al., 2008).~   "
63248|NCT02229409|"~     This study evaluates the product Walkadoo to determine whether it effectively increases~     walking behavior in healthy adults.~   "
63249|NCT02229396|"~     Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,~     Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous~     administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)~     compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes~     who have inadequate glycemic control on metformin.~   "
63250|NCT02229383|"~     Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel~     group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added~     to titrated basal insulin glargine with or without metformin to placebo added to titrated~     basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus~     (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added~     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added~     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the~     28-week treatment period.~   "
63251|NCT02229370|"~     To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The~     aim of this study is to collect data on ECAA and its treatment to assess the natural history~     of ECAA and the success and safety of different treatment strategies.~   "
63252|NCT02229357|"~     This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose~     between subjects previously vaccinated with LAIV H5N2 and naïve subjects~   "
63253|NCT02229344|"~     The purpose of this study is to describe clinical course of newly diagnosed moderate to~     severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral~     hospitals in Korea for 5-year follow-up under usual care.~   "
63254|NCT02229331|"~     Haemophilia is a rare X chromosome-linked coagulation disorder resulting from a congenital~     deficiency or absence of circulating factor VIII (Haemophilia A) or factor IX (Haemophilia~     B).As a consequence, patients with haemophilia are unable to generate adequate thrombin~     resulting in abnormal bleeding. Approximately 80-90% of bleeding episodes occur in the~     musculoskeletal system, especially in the large synovial joints and muscles. Repeated~     haemarthrosis induce joint cartilage damage and irreversible degenerative joint disease.~      Regular intravenous administration of coagulation factor concentrates starting after the~     first joint bleed and/or before the age of 2 ('primary' prophylaxis) is now the~     evidence-based, first-choice treatment in children with severe haemophilia. This primary~     prophylaxis has radically decreased the incidence of arthropathy in patients with~     haemophilia. Despite the positive effect of primary prophylaxis on arthropathy at several~     joints, the ankle joint seems to be an exception to the rule, as patients with haemophilia~     treated with primary prophylaxis still experience ankle arthropathy. As such, the ankle now~     is the main affected joint in patients with haemophilia under the age of 20. This makes the~     scientific community facing a new challenge. Determining aetiologic/contributing factors~     associated to the ankle arthropathy pathophysiological cascade in children with haemophilia~     (CwH) is therefore a primary objective in the haemophilic research community nowadays.~      Loading of the ankle is crucial as the ankle plantar flexors provide the main propulsive~     power during gait, the tibiotalar joint caries a complex distribution of joint stresses as a~     consequence of talar morphology and kinematics and, from a biomechanical and biochemical~     viewpoint, differs significantly from other major lower limb joints. Previous biomechanical~     studies focused on kinematic and strength measures, however, they omitted to incorporate~     fundamental measures of joint loading (joint kinetics) and joint structural integrity (JSI,~     assessment of soft tissue and osteochondral integrity through MRI). This makes it impossible~     to draw firm conclusions on biomechanical contributing factors. Furthermore, few,~     low-quality studies focused on conservative treatment strategies (e.g. strength training,~     mobilisation, proprioceptive training) in patients with ankle arthropathy. In a minority of~     the cases, important adverse effects (joint bleeding during strength and proprioception~     training) have been reported. Because of the low quality of the intervention studies and the~     lack of biomechanical studies focusing on joint loading and joint integrity, it is~     impossible to pinpoint the aetiology of these side effects. One assumption might be that~     side effects originate from inappropriate conservative approaches as a consequence of~     lacking knowledge on joint loading and joint integrity.~      An innovative approach within the domain of ankle arthropathy in CwH is therefore to study~     foot and lower limb kinetics during gait. The quantification of foot joints kinetics~     encompasses considerable challenges and, until recently, only simplified single-segment foot~     models have been used. Those models typically underestimate the mechanical contribution of~     the different foot joints and, of equal importance, overestimate the kinetic contribution of~     the tibiotalar joint.~      To overcome the above mentioned shortcomings, a valid 3D Multisegment Foot Kinetic Model~     (3DMFKM) should be developed and introduced within the population of CwH. This is important~     as it allows to quantify increased loading at the tibiotalar joint (or other joints) that~     may help to explain this ankle arthropathy in these patients. This will have been missed by~     previous research due to the consideration of the foot as one entire segment.~      Providing a classification system based on these kinetic data would, in a second stage, be a~     pertinent and valuable approach as this provides a rationale for designing randomized~     controlled trials.~      In this perspective, it is also recommended to assess the relationship with other~     biomechanical and anatomical determinants, especially if one aims at developing optimal~     management and rehabilitation strategies.~   "
63255|NCT02229318|"~     Subjects will be asked to substitute their usual vitamin and mineral supplement/s with~     FruitiVits for seven consecutive days.~   "
63256|NCT02229305|"~     This study focused on youths who were referred to community-based mental healths clinics for~     problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any~     combination of these problems. Therapists were randomly assigned to deliver usual treatment~     procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment~     (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct~     Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment,~     and every 3 to 6 months for two years. Results will address critical questions about~     deployment of evidence-based youth practices to clinical settings.~   "
63257|NCT02229292|"~     Purpose of the study:~        -  To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in~          patients subjected to bi-maxillary orthognathic surgery~        -  To evaluate the potential effect of TXA on fibrin structure~        -  To evaluate the potential effect of TXA of binding of plasminogen to fibrin~        -  To evaluate the potential effect of TXA on postoperative edema formation.~      Hypothesis:~      H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration~     of tranexamic acid~      H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of~     tranexamic acid~   "
63258|NCT02229279|"~     The objective of this study is to assess the medical and economic relevance of~     teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.~   "
63259|NCT02229266|"~     The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural~     killer cells compared to standard chemotherapy (after first complete remission) in patients~     with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible~     for allogeneic transplantation~   "
63260|NCT02229253|"~     Patients with prostate cancer and a history of cardiovascular disease treated with degarelix~     for their prostate cancer, will be followed for a period of one year. In this real-life,~     non-interventional trial, any cardiovascular events occurring during degarelix therapy will~     be documented.~   "
63603|NCT02224768|"~     To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in~     terms of awareness about these tools, their utilization, knowledge and comprehension of~     Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional~     (HCP)s and patients~   "
63261|NCT02229240|"~     This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter,~     treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety~     of once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin~     therapy (with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM).~     Approximately 450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment~     groups: albiglutide + intensified basal-bolus insulin therapy (with or without metformin) or~     placebo + intensified basal-bolus insulin therapy (with or without metformin. The total~     duration of a subject's participation will be approximately 32 weeks.~   "
63262|NCT02229227|"~     This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat~     to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of~     once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes~     mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus~     insulin regimen (with or without metformin). Approximately 794 subjects will be randomly~     assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with~     insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification~     of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4~     study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and~     Post treatment Follow up (4 weeks). The total duration of a subject's participation will be~     approximately 36 weeks.~   "
63263|NCT02229214|"~     The main purpose of this study is measure the effect of VI-0521 on kidney function.~     Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks~     of study treatment, and after an additional 4 weeks of off-treatment recovery.~   "
63264|NCT02229201|"~     Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of~     inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released.~     Cell mediated immune balance can increase postoperative complications (infections, wound~     healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics~     reduce systemic and local inflammatory response during major surgery, but animal studies~     have shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads~     to decline of cognitive function in rodent and possible human.~      Our aim was to investigate how anaesthetic technique for craniotomy influences the release~     of inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies~     are followed during surgery intravenous anaesthesia attenuates inflammatory response~     comparing to inhalational anaesthesia.~      The investigators included 40 patients anaesthetised with remifentanil based anaesthesia~     with sevoflurane (S group) or propofol (P group).~      Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and~     postoperative periods of both groups of patients. The investigators also noted emergence~     parameters, postoperative (pain, shivering, vomiting) and neurological complications after~     surgery.~   "
63265|NCT02229188|"~     This is a pilot study divided into two phases. IN phase 1 (completed) participants will be~     randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a~     cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now~     recruiting), participants will be randomized to Evo, PST, and a different cognitive training~     program called Words. Words is similar to Evo in that it is an adaptive training program and~     includes case management. IN both studies participants will be assessed for clinical and~     functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.~   "
63266|NCT02229175|"~     Currently, diabetic macular edema is treated is through injection of a medications such as~     off-label bevacizumab, which decreases the swelling in the retina. These injections are~     sometimes required monthly until the condition is controlled. Recently, there have been some~     new FDA approved treatments using laser that decrease the swelling. These approximately ten~     minute treatments do not require injections and don't cause permanent damage to the eye, and~     they may decrease the number of injections one needs to get to treat diabetic macular edema~     (DME).~      The purpose of this randomized clinical trial is to determine whether subvisible laser in~     combination with intravitreal bevacizumab is non-inferior compared to current standard of~     care (intravitreal bevacizumab alone) in achieving favorable outcomes for visual acuity,~     mean macular thickness, and patient quality of life, and has fewer needed intravitreal~     bevacizumab injections throughout the course of the 12 month study period.~   "
63267|NCT02229162|"~     This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90~     to 120 seconds) during elective cesarean deliveries of term infants. The investigators~     hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this~     procedure for mothers and babies.~   "
63268|NCT02229149|"~     This randomized phase 2 study will seek to determine the effectiveness of chemotherapy~     (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or~     capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus~     pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been~     previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.~   "
63269|NCT02229136|"~     This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses~     (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention~     or treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients~     undergoing treatment with an aromatase inhibitor plus everolimus. An exploratory analysis~     will also evaluate patient response to next anti-cancer therapy of physician's choice~     following discontinuation of therapy with an aromatase inhibitor plus everolimus.~   "
63270|NCT02229123|"~     LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment~     strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this~     study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam~     as first line treatment in term new born babies with seizures. This new anticonvulsivant~     drug is a promising treatment for seizures in newborns.~   "
63340|NCT02228187|"~     The primary objective is to examine the efficacy of 8-weeks of a locally developed~     brain-computer interface based system intervention for improving attention and memory in~     healthy elderly and those with age related cognitive decline. We hypothesize that elderly~     who have completed the training program will have significant improvement in their attention~     and memory compared to the controls, based on the Repeatable Battery for the Assessment of~     Neuropsychological Status.~   "
63271|NCT02229110|"~     Patients with type 2 diabetes mellitus can receive care in the general practice or at the~     outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices~     and the hospital are connected through Diamuraal to organize the diabetes care in that~     region. They work in the same electronic medical record, and patients can request access to~     their own record (called a patient web portal). They set up Diamuraal guidelines, based on~     the guidelines of the Dutch College of General Practitioners and Internists, on where the~     patient care needs to be allocated (primary or secondary care), depending on the amount of~     specific care a patient needs. Despite guidelines, not all patients are treated in the~     correct place.~      Our hypotheses is that when we improve triage we can cause a major shift from treatment in~     secondary care to primary care and from primary care to self-care by using the patient web~     portal. Furthermore, patients who needs extra attention due to problems with their diabetes~     or complications can receive this extra attention due to increased e-consultation between~     primary care and secondary care and if necessary actually can, during a short time, be~     treated by an internist. We hope to achieve this by introducing a signal in the electronic~     medical record. This signal allocates patients according to the guidelines and warns a~     physician if their patients is not treated according to that guideline. The health care~     provider can then discuss this situation with his patient. We believe that this leads to~     shift in allocation of care, in which optimal care is provided and patients are made more~     aware of their situation which hopefully leads to better self-management and satisfaction.~   "
63272|NCT02229097|"~     A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a~     better coordination of meal boluses and post prandial basal rate could reduce the importance~     of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.~      The aim of the investigators study is to assess if these results are confirmed in a clinical~     trial.~      The aim of this study is to compare the efficacy of coordinated boluses versus normal~     boluses on postprandial glycaemic control of T1D patients treated with continuous~     subcutaneous insulin infusion.~   "
63273|NCT02229084|"~     The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide~     mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients~     with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer.~      This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to~     evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with~     neoadjuvant chemotherapy and (2) to determine if the pCR rate among ER-positive~     breast-cancer patients treated with the combination is significantly higher than the 8% rate~     observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized~     clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in~     combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or~     III ER-positive breast cancer.~   "
63274|NCT02229071|"~     This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and~     receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients~     wiht advanced hepatocellular carcinoma (HCC) .~   "
63275|NCT02229058|"~     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin~     Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric~     cancer.~   "
63276|NCT02229045|"~     The purpose of this study is to evaluate the effectiveness and safety of albumin bound~     paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients~     with advanced gastric cancer.~   "
63277|NCT02229032|"~     There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a~     specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A~     gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may~     have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success~     and lack of response with this therapy. Genetic analysis of the differences between Dravet~     responders and non-responders may prove useful for identifying patients likely to be helped~     by this therapy, as well as shed light on the putative mechanisms by which marijuana may~     exert any antiepileptic effect.~   "
63278|NCT02229019|"~     The Southampton Mealtime Assistance Study aims to determine whether it is feasible and~     acceptable to introduce trained volunteers as mealtime assistants in five different~     departments of one large hospital.~   "
63279|NCT02229006|"~     The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron~     Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of~     abdominal aortic aneurysm expansion.~   "
63280|NCT02228993|"~     Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors~     involving or adjacent to the eloquent or motor cortices, those portions of the brain that~     are responsible for language and motor skills, respectively. By mapping those areas of the~     brain that are necessary for such functions, the neurosurgeon is able to avoid resection of~     cortical tissue that might compromise the patient's abilities to speak or move, hence~     preserving neurologic function. AC is often accomplished by direct cortical stimulation or~     inhibition, while maintaining the patient's ability to interact with the operative team. The~     anesthetic technique often involves a regional (scalp) block combined with intraoperative~     intravenous mild sedation. In some reported instances of AC, no cortical mapping is~     performed, and the technique is performed solely because it is thought that AC leads to a~     better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)~     than craniotomy performed under general anesthesia.~      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has~     been used in various postoperative populations to assess the overall satisfaction and~     well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported~     that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison~     between AC patients and general anesthesia craniotomy (GAC) patients using this tool has~     never been performed.~      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The~     well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,~     consists of 12 items. It measures two domains, including mental and physical component~     summaries (mental component summary and physical composite score, respectively).~      Hypothesis:~      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of~     recovery in the immediate postoperative period, and better 30 and 90 day quality of life~     outcomes, than craniotomy performed under general anesthesia.~   "
63281|NCT02228980|"~     The main purpose of this trial is to describe the product profile in terms of immunogenicity~     and safety following administration of trivalent influenza vaccine (split-virion,~     inactivated) produced at Shenzhen (SP Shz TIV).~      Primary objective:~        -  To describe in each group the immune response induced by a single dose (subjects aged ≥~          3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.~      Secondary objective:~        -  To describe in each group the safety profile of the vaccine after a single dose~          (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35~          months).~   "
63282|NCT02228967|"~     An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be~     adapted for use in a large military hospital setting, and then pilot tested in a military~     emergency department (ED) to assess its potential for effectiveness and for further testing~     in a large-scale trial. SBIRT is an opportunistic approach whereby all adult patients in~     the ED are screened by Health Educators for their alcohol use, and then, taking advantage of~     a teachable moment, are delivered a brief, motivational intervention matched to their~     level of risk.~      The feasibility/formative research activities in the first phase (Phase I) of the study are~     not summative research, and therefore, do not lend themselves to testable hypotheses.~     Hypotheses with regard to the pilot randomized trial in Phase II are as follows:~        1. Participants in the SBIRT intervention will show relatively greater reductions over a~          six month period (or less increase) than the brochure/usual care control group in the~          prevalence of past-month heavy drinking, frequency of heavy drinking, past week number~          of drinks, and the AUDIT-based drinkers' index.~        2. Alcohol use-related motivation/readiness to change and controlled drinking~          self-efficacy will show greater change in the SBIRT intervention group relative to the~          brochure/usual care control group.~           In addition, exploratory analyses will examine the following:~        3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of~          service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline~          readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.~   "
63283|NCT02228954|"~     Rationale. In part of the patients with good and intermediate risk metastatic renal cell~     carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is~     not necessary. By now, the investigators are not able to identify those patients with~     indolent disease and the minor group of patients with rapidly progressive disease. In~     patients with indolent disease, a watchful waiting period is preferred, since their quality~     of life will not be unnecessary hampered by adverse events and therapy resistance is not~     induced. This study aims to identify those patients for whom a watchful waiting period is~     possible by molecular imaging. Furthermore several types of systemic therapy are possible~     once the progression is proven. These systemic treatments are comparable in terms of~     efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary~     objective, the usefulness of a decision aid guiding the choice of the patients is studied.~      Objectives.~      To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful~     waiting, the added value beyond clinical work-up of:~        1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid~          progression (≤ 2 months after the baseline scan) under watchful waiting.~        2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged~          indolent (≥12 months after the baseline scan) disease under watchful waiting.~      To assess the value of a therapy choice decision aid for patients with progressive disease.~      Study design. This is a multicenter non-blinded prospective observational study in 80 good~     and intermediate prognosis mRCC patients.~      Study population. Patients with good or intermediate prognosis mRCC according to the Heng~     criteria, ≥18 years, without contra-indications for a watchful waiting period, able to~     provide informed consent.~      Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the~     watchful waiting period, disease evaluation by CT according to the RECIST criteria will be~     made frequently, until established progressive disease. At that moment, a second FDG-PET-CT~     and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second~     89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to~     choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α~     with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy~     (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a~     separate phase II study.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness.~      At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the~     watchful waiting period CT's will be made. During therapy, follow-up will include standard~     laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects~     of the medication and adverse events as a consequence of the tumor biopsies may occur. The~     radiation exposure of both PET investigations is acceptable and requires no shielding after~     injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or~     stabilization. All three treatment choices has proven clinical benefit in this patient~     population. The risks of participation into the RIT trial are described in the phase II~     trial protocol, which already has been judged by the Medical Ethics Review Committee.~   "
63284|NCT02228941|"~     Hyper IgE syndrome (HIES) is a rare and complex primary immunodeficiency that affects~     multiple systems. It is characterized by elevated Immunoglobulin E(IgE), recurrent skin and~     pulmonary infections and eczematoid dermatitis.Somatic manifestations include scoliosis,~     joint hyperextensibility, impaired shedding of deciduous teeth and facial dysmorphism.~      The reason of extremely high level of serum IgE in the patients with HIES is unknown. Signal~     transducers and activators of transcription 3(STAT3) gene mutations can cause the~     STAT3/Janus kinase(STAT3/JAK) signal transduction pathway disorder, then can affect the B~     cell development.~      It is reported that levels of extracellular signal cytokine and the prolonged half-life of~     IgE are not the causes of dramatically increased IgE levels in STAT3-HIES patients.~     According to our preliminary work, we found that the slight increase of IgE-secreting plasma~     cells could not explain the tremendously increased IgE level and that the key class switch~     recombination enzyme (AID) was up-regulated in STAT3-HIES patients. Intriguingly, we found~     that deregulation of immunoglobulin class switch recombination (CSR) in IgE secreting plasma~     cells in STAT3-HIES patients might play a key role in dramatically increased IgE levels.~      Nuclear factor IL-3 regulated (NFIL3) is a newly discovered transcriptional factor. During~     STAT3-HIES IgE-secreting plasma cells differentiating, NFIL3 was significantly upregulated.~     The CSR of IgE was down-regulated in STAT3-deficiency mice as well as NFIL3-deficiency mice,~     however Interleukin-4（IL-4）, a STAT3-independent cytokine, promotes NFIL3 expression by~     Signal transducers and activators of transcription 6(STAT6) dependent manner. Thus, we~     hypothesize that NFIL3 may play a key role in dramatically increased IgE levels in~     STAT3-HIES patients.~      In-depth insight of the pathogenic role of NFIL3 within human STAT3-HIES has great~     significance in clarifying the pathogenesis of HIES and exploiting effective targeting~     interventions to improve clinical outcomes. Also, it can provide valuable clues for the~     clinical treatment of IgE-related diseases, such as parasite infection and malignant~     diseases.~   "
63285|NCT02228928|"~     The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)]~     capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch~     in patients suffering from peripheral neuropathy~   "
63286|NCT02228915|"~     The purpose of this research study is to discover and quantitate the differences in~     post-translational modifications found in the Cu, Zn superoxide dismutase (SOD1) of patients~     with amyotrophic lateral sclerosis (ALS) as compared to healthy individuals. SOD1 is a known~     genetic cause of ALS. With certain mutations, SOD1 gains a toxic function which leads to~     motor neuron death.~   "
63287|NCT02228902|"~     Introduction: There are indications that the absorption of oral iron supplementation is~     reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as~     standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric~     bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to~     a insufficient treatment of oral iron suppletion.~      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.~     Two groups will be created.~      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2~     receives a daily dose Losferron (1390mg).~      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron~     including ferritin, transferrin and transferrin saturation will be measured. After intake of~     losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after~     intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron~     absorption. All patients undergo a Roux- en -Y gastric bypass.~      Postoperatively; one month postoperatively the same absorption test will be repeated in the~     same patients.~   "
63288|NCT02228889|"~     The purpose of the study is to compare the clinical outcomes of two commonly used,~     FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice~     and XenMatrix). The two meshes are derived from pig skin from which cells have been removed~     and which have been sterilized. The two meshes are made by two different companies using~     different processes.~   "
63289|NCT02228876|"~     This 3-year proposal is a family-based cohort study to establish a representative sample of~     probands with ASD and their parents with well-characterized environmental, clinical~     phenotypes, endophenotypes, and genetic data to conduct CNV experiments and the~     genotype-phenotype correlations. Based on our previous findings, probands with CNVs larger~     than 500kb has been identified and their families will be newly recruit in the present~     project to reveal the origin of the CNVs and reveal the clinical feature of the families.~     The significant findings in specific genes will conduct pathway analysis to reveal the~     etiology in ASD, providing further understanding in the disease.~   "
63290|NCT02228863|"~     Concomitant use of botulinum toxin and robot would make better results regarding upper~     extremity function compared to robot, botulinum toxin, or no intervention.~   "
63291|NCT02228850|"~     The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a~     diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).~   "
63341|NCT02228174|"~     The objective of this study is to establish the safety and effectiveness of the Sonata®~     System in the treatment of symptomatic uterine fibroids.~   "
63342|NCT02228161|"~     This study will investigate if yoga exercises decrease work-related stress and improve~     stress adaptation in professional health helpers.~   "
63604|NCT02224755|"~     The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by~     demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of~     advanced, refractory, left ventricular heart failure.~   "
63292|NCT02228837|"~     The hypothesis of this study is that the daily consumption of 2 medium-sized pears for~     twelve weeks will improve blood pressure, lipid profiles, glycemic control and insulin~     resistance, inflammatory and oxidative status in men and women with metabolic syndrome. 50~     men and women between the ages of 45 and 65 who have three of the five features of metabolic~     syndrome as defined by the Adult Treatment Panel III will be included in the study. After a~     two-week run-in phase, eligible men and women will be randomly assigned to one of two~     treatment groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks.~     After an initial telephone screening, all participants will be requested to report to the~     study site for their first visit. On the first visit (screening), participants will be~     provided with verbal and written explanation of the project. They will then be asked to sign~     an informed consent form, followed by measuring waist circumference, resting brachial blood~     pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose~     levels to confirm metabolic syndrome. Baseline assessments will be performed for medical~     history, medication use, dietary intake, and physical activity. Qualified participants will~     be scheduled for their second visit two weeks later (actual baseline data collection) and~     randomly assigned to their treatment group. On the second (baseline) visit between the hours~     of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.~     Anthropometrics and body composition will be measured. Questionnaires regarding diet,~     physical activity, and gastrointestinal health will be performed. Participants will be~     provided with their assigned treatment and will receive standard instructions on how to fill~     out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),~     and 12-week (final visit) intervals. All assessments and information will be collected after~     an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the~     last bout of moderate to heavy physical activity. After the initial 12 weeks, participants~     will undergo a 4-week washout period in which they will not consume either the intervention~     or the placebo. After the 4-week washout period, participants will crossover into the other~     group to receive either the intervention or placebo.~   "
63293|NCT02228824|"~     The purpose of this research study is to investigate the impact of different nicotine levels~     in cigarettes among non-daily smokers. This research may help inform the Food and Drug~     Administration (FDA) on how best to regulate tobacco products in the future, with the goal~     of improving public health.~   "
63294|NCT02228811|"~     The main purpose of this study is to investigate the safety of the investigational drug~     DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer~     that has spread to other parts of the body.~   "
63295|NCT02228798|"~     The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to~     establish a safe, standardized protocol for the perioperative management of patients with~     atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either~     dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.~   "
63296|NCT02228785|"~     This study was designed to investigate the safety and tolerance of three doses (100µg,~     200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.~   "
63297|NCT02228772|"~     This research study is evaluating a combination of drugs considered standard treatment for~     children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new~     drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell~     transplantation, which will be given to some participants, helps to prevent ALL from~     returning.~   "
63298|NCT02228759|"~     Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks~     with continuous adductor canal block along with multimodal analgesia started pre-operatively~     and continued into the postoperative period. The study will evaluate the feasibility of home~     discharge within the first 24 hours following total knee arthroplasty. We will also evaluate~     the pain scores in the first 5 days following the surgery, causes of delayed discharge and~     any adverse events.~   "
63299|NCT02228746|"~     Clinical intervention on overweight or moderately obeses adults. The objective of this trial~     is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a~     low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in~     cardiometabolic risk factors through the intervention have been evaluated as secondary~     endpoints~   "
63300|NCT02228733|"~     This single ascending dose (SAD) study in healthy subjects will evaluate the safety,~     tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium~     and urine albumin levels) relationships will be explored to support the selection of dosing~     regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the~     efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of~     nephropathy as well as control hypertension.~   "
63301|NCT02228707|"~     The primary objectives of the study are to evaluate the safety and tolerability of multiple~     doses of BIIB061 administered to healthy adults. The secondary objective is to determine the~     multiple-dose PK profile of BIIB061 in this study population.~   "
63302|NCT02228694|"~     An automated dispensing cabinet (ADC) is a computerized drug storage device or cabinet~     designed for hospitals. ADCs allow medications to be stored and dispensed near the point of~     care while controlling and tracking drug distribution.This study seeks to obtain~     quantitative measurements of the impact of the regulated ADC System installed in select high~     volume units throughout the hospital.~   "
63303|NCT02228681|"~     The main purpose of this study is to evaluate the effectiveness of the combination of the~     drugs Everolimus and Letrozole compared to Tamoxifen and Medroxyprogesterone acetate in~     treating endometrial cancer and to determine the types and severity of side effects caused~     by treatment with these drug combinations.~   "
63316|NCT02228499|"~     Background: Asthma is the most common chronic disease of childhood with a prevalence that is~     1.6 times greater in African American (AA) children than in Non-Hispanic White children.1~     Nationally, 700,000 children are seen for asthma in Emergency Departments (ED) every year,~     1% of which are seen at Children's National Health System (CN) in Washington, DC. School~     performance and school attendance has not been well studied in urban children with asthma,~     especially at the middle school level.~      Objective: Our purpose is to test the hypothesis that middle school children with asthma~     have worse school performance than middle school children without asthma in Washington DC~     and Prince George's county schools.~      Methods: The investigators will conduct a cross-sectional observational study of~     middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without~     asthma recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The~     investigators will collect demographic information, asthma severity information (for cases),~     and request that parents mail report cards and standardized test scores directly to the~     investigators. The investigators will use multivariable linear and logistic regression to~     determine if the presence of asthma is associated with school performance.~   "
63817|NCT02221973|"~     The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids~     reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:~     demonstrate potential to reduce total blood cholesterol more than 10% and/or total~     triglycerides more than 15%, as required by State food and drug administration (SFDA)~     regulation.~   "
63304|NCT02228668|"~     The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow~     up of patients previously included in the AVANT trial from December 2004 to June 2007.~      Clinical data of the AVANT trial will be updated. Neither additional examination nor~     administration of any treatment will be performed on the patients.~      330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,~     Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,~     Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,~     Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,~     Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).~      The AVANT study aiming at demonstrating superiority of bevacizumab in combination with~     FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when~     adding bevacizumab to chemotherapy in resected stage III colon cancer.~      Adverse events were consistent with the known safety profile of bevacizumab. However, more~     relapses and deaths due to disease progression have been observed in both bevacizumab arms.~      A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term~     results and safety.~      Collection of additional follow-up data will start Q3 2014. Clinical data are to be~     collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year~     median follow-up (expected to be reached around Q2 2016).~      All analyses will be performed on an exploratory purpose only. An analysis at 8 years median~     follow-up and a final analysis at 10 years median follow-up will be performed in the main~     population (all randomized patients in the AVANT trial including patients lost to follow up~     or died).~   "
63305|NCT02228655|"~     FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.~   "
63306|NCT02228642|"~     Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at~     risk for losing the ability to develop symptoms that warn them that they are having a low~     blood sugar. There is almost no available information investigating how the inability to~     feel symptoms of a low blood sugar contributes to the risk of this happening when people~     with diabetes are hospitalized. The purpose of this study is to develop a symptom score~     model that will help to identify patients at risk for low blood sugars in the hospital and~     to examine what happens to patients who do experience a low blood sugar in the hospital.~   "
63307|NCT02228629|"~     Foot complications are a common and costly problem for subjects with diabetes. Although~     Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not~     wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such~     as flip flops or slippers, that provide little to no protection against injuries. While~     proper house shoe is important in the prevention of diabetic foot complications, this area~     has not received much attention. The purpose of this pilot study is to assess if CrocsRx~     Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles,~     and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to~     conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design~     will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with~     the order of shoes randomized.~   "
63308|NCT02228616|"~     The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally~     once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with~     Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by~     the percentage of subjects with a weekly average increase of 1 or more spontaneous complete~     bowel movements (SCBMs) (responders) during the 12-week treatment phase as compared to the~     baseline.~   "
63309|NCT02228603|"~     Exercise training is a core component in cardiac rehabilitation. Exercise adherence is,~     however, low after rehabilitation and the transition from supervised to unsupervised~     exercise is problematic for many patients with coronary artery disease. Therefore, it is~     important to provide extended services to improve exercise adherence and healthy lifestyle~     changes.~      The aim of this study is to assess the effect of a time-limited intervention following~     out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.~   "
63310|NCT02228590|"~     The primary objective of this study is to evaluate the efficacy, tolerability and safety of~     single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)~   "
63311|NCT02228577|"~     This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted~     using the Model 241 Applier. The objective of this study is to characterize and evaluate the~     safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.~   "
63312|NCT02228551|"~     This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a~     measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult~     non-critically ill abdominal and trauma surgery population. Secondary objectives are the~     identification of risk factors associated with ARC in this specific study population.~   "
63313|NCT02228538|"~     The purpose of this study is to obtain patient oriented and clinically oriented physical~     function outcomes both pre-operatively and post-operatively in patients receiving a total~     knee arthroplasty.~   "
63314|NCT02228525|"~     The purpose of this study is to see if selinexor will improve the blood counts and bone~     marrow function in people with your type of MDS.~   "
63315|NCT02228512|"~     Background:~      - The chemotherapy combination DA-EPOCH-RP includes the drugs etoposide (E), prednisone (P),~     vincristine (O), cyclophosphamide (C), doxorubicin (H), rituximab (R), and pomalidomide (P).~     Researchers want to see if including pomalidomide will help people with two rare lymphomas.~      Objectives:~      - To study the safety and efficacy of the chemotherapy drugs DA-EPOCH-RP.~      Eligibility:~      - Adults at least 18 years old. They must have primary effusion lymphoma or large cell~     lymphoma arising from Kaposi sarcoma Herpesvirus-associated multicentric Castleman disease.~      Design:~        -  Participants will be with screened with blood tests, scans, spinal tap, and bone marrow~          sample. They may have skin or lymph node samples taken and fluid removed from around~          some organs.~        -  Participants will have breathing and eye tests. A camera may take pictures inside their~          body.~        -  Participants will take pomalidomide alone by mouth for up to 21 days. Then they will~          get rituximab by intravenous (IV) catheter, which is a small tube that goes into a~          vein..~        -  Participants will have an IV inserted in an arm or chest vein to get the IV~          chemotherapy drugs, at the same time the will take pomalidomide by mouth for 5 days.~        -  They will get DA-EPOCH-RP in 21-day cycles. Most people will have 6 cycles.~        -  They will get 4 study drugs by IV for 5 days and 2 others by mouth for 5 days.~        -  They will get daily filgrastim injections in the skin until white blood counts are~          acceptable~        -  For 2 days of some cycles, methotrexate will be injected into the spinal fluid.~        -  After completing EPOCH-RP, some participants who have Kaposi sarcoma will be prescribed~          pomalidomide for 3-weeks, followed by a one week break, for up to 12 months.~        -  Participants will repeat the blood tests often. They will also have repeated medical~          history, physical exam, urine and stool tests, and pictures of any rashes associated~          with these lymphomas.~        -  Participants will have several follow-up visits over 4 years.~   "
63317|NCT02228486|"~     Relapse is a major risk in substance abuse disorders, which is closely related to craving~     for a substance, describing a strong urge for consumption. Cue-exposure therapy is an~     intervention aiming at the reduction of perceived craving by repeated confrontation. It is~     based on the assumption that craving drops after repeated exposure without the reinforcing~     experience elicited by consumption. In the present study, patients with alcohol dependency~     take part in nine cue-exposure training sessions. Each session consists of mood induction~     reflecting a high risk situation with subsequent in vivo confrontation with one's preferred~     alcoholic beverage followed by the training of coping strategies. During the cue-exposure,~     patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize~     that especially patients exhibiting initially high reactions to such cues should profit from~     this intervention the most. The reactions are measured on a subjective (craving) and~     physiological level (hemodynamics of the prefrontal cortex, heart rate variability,~     electrodermal activity). Furthermore, we want to strengthen the expected training effects~     during the cue-exposure by an activating transcranial direct current stimulation of the~     dorsolateral prefrontal cortex, which has been shown to be hypoactive in substance abuse~     disorders. We investigate how the cue-exposure training affects the processing of alcoholic~     cues (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.~   "
63318|NCT02228473|"~     We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of~     catheter-related bladder discomfort.~   "
63319|NCT02228460|"~     Primary Objective:~      To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy~     of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male patients diagnosed~     with Fabry disease.~   "
63320|NCT02228447|"~     The purpose of this study is to evaluate the impact of a multicomponent school-based~     intervention based on Bandura's Social Cognitive Theory targeting healthy eating and~     physical activity for high school adolescent girls from low-income communities in the city~     of São Paulo, Brazil.~   "
63321|NCT02228434|"~     The project aims at developing the tailored intervention strategy of childhood obesity based~     on monitoring physical activities with accelerometer and dietary behaviors using diary. It~     probably raise the passion of obese children to control weight, form healthy life style, be~     effective in sustaining weight loss and early prevent adulthood diseases.~   "
63322|NCT02228421|"~     This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of~     crizotinib and its companion diagnostic test used in a real-life setting in advanced~     ALK-positive non-small cell lung cancer (NSCLC) patients.~      NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the~     ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor~     tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in~     NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is~     capable of activating the ALK kinase domain, leading to cell growth. The estimated~     prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst~     patients with adenocarcinoma histology, in never smokers and in those who are known to be~     wild type for EGFR and KRAS.~      Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+~     NSCLC patients. This is an example of personalized medicine, where patients are selected for~     treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for~     their disease. The pharmacoeconomic impact of using genetic information in early treatment~     decisions in NSCLC has not been determined.~      The study will enable real-life Heath Economics and Outcome Research (HEOR).~      Approximately 90 patients will be recruited. Patients will be asked to complete~     quality-of-life questionnaires at regular intervals in a real-life setting of treatment with~     crizotinib.~   "
63323|NCT02228408|"~     This study is a pilot study designed to compare the safety and cardiovascular effects of 26~     weeks of combination hydralazine/isorsorbide dinitrate therapy with amlodipine therapy in~     patients receiving chronic hemodialysis.~      The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a~     combination of hydralazine/isosorbide dinitrate compared with amlopdipine is safe and that~     it will improve heart function as well blood flow/blood vessel supply.~   "
63324|NCT02228395|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of single ascending doses in healthy volunteers~   "
63325|NCT02228382|"~     The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to~     the European Medicines Agency in providing additional safety and efficacy data in~     approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with~     high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase~     patients in the fourth or later line treatment setting (i.e., after treatment with at least~     3 other Tyrosine Kinase Inhibitors).~   "
63326|NCT02228369|"~     This is the first time in patient study to assess the safety, tolerability and preliminary~     efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this~     study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to~     assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity~     of AZD9291~   "
63327|NCT02228356|"~     The investigators recently published 2 phase II trials on the use of helical tomotherapy for~     oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered~     in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate~     is probably the result of geographical misses due to tumor motion and a biologically~     effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year~     local control rate can be improved to 70%, using respiration correlated CT to individualize~     the margin needed to account for tumor motion, to avoid geographical miss, together with a~     Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80%~     isodose, allowing higher doses in the tumor core. As the concept of an internal target~     volume (ITV) may result in large margins for patients displaying metastases in high mobile~     organs, such as liver and lung, which may lead to exposure of a relatively high dose to a~     large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be~     applied in those patients.~   "
63328|NCT02228343|"~     Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk~     factors in patients with coronary artery disease.~   "
63818|NCT02221960|"~     To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with~     recurrent or metastatic solid tumors.~   "
63330|NCT02228317|"~     A large part of acutely ill patient's access to the health care system starts by calling the~     emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch~     center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the~     hospital. These patients are not referred by a physician (eg. a GP) and represent an~     unselected subpopulation of the acutely ill patients. At present, all non-critically ill~     patients not evaluated by a pre-hospital physician are normally be transported to hospital~     as category 2 (without activated emergency lightning and sirens).A part of this patient~     population, however, is not critically ill and a proportion of these may not need hospital~     admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave~     patients without a physician's involvement. If the EMT had 24/7 online access to medical~     control i.e. in form of a physician present in the EMDC , the number of patients transported~     to hospital for assessment may be reduced as well as response times for patients actually~     needing ambulance transportation. This could potentially reduce the workload on the whole~     healthcare system involved in the management of these patients - thereby potentially~     reducing costs.~      The objective of this study is to evaluate if a systematic telemedical assessment by an~     EMDC-physician of all patients who receive an ambulance but are not critically ill and would~     have a category 2 transport to hospital can reduce the number of the patients that are~     transported to hospital and save costs and time.~   "
63331|NCT02228304|"~     Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients~     treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation~     at year 2. Those who, in the opinion of the investigator, are still candidates for continued~     anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and~     followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,~     randomized, masked phase during which eligible patients will be randomized to the NT-503-3~     group or the control group.~      Clinical Hypotheses:~        -  NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the~          prevention of vision loss due to recurrent CNV secondary to AMD~        -  NT-503-3 ECT has an acceptable safety profile~   "
63332|NCT02228291|"~     This randomized, double-blind, placebo-controlled, parallel study aims to determine the~     6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and~     intestinal health as assessed by investigation of endothelial function, blood pressure and~     heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh~     subjects.~      Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum~     levels of specific metabolites of the study product.~   "
63333|NCT02228278|"~     The purpose of this study is to determine if health-related text messages sent from~     healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid~     clinic will result in increased adherence to their nutrition and physical activity goals and~     improve their weight loss. The study will also assess if the volume of texts per week~     impacts outcomes. This will be a small scale pilot study, with plans for a future larger~     scale study to assess for statistically significant effects.~   "
63334|NCT02228265|"~     This research trial studies molecular features and pathways in predicting drug resistance in~     patients with hormone-resistant prostate cancer that has spread to other parts of the body~     and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory~     from patients receiving enzalutamide may help doctors learn more about molecular features~     and pathways that may cause prostate cancer to be resistant to the drug.~   "
63335|NCT02228252|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate the effect of protein quality and the time factor~     of protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and~     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,~     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying~     and metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich~     isocaloric meal reduces triglyceride- and ApoB48 responses more compared to casein protein~     and gluten protein consumed 15 minutes prior to the meal and whey protein consumed 30~     minutes prior to the meal in subjects with MeS.~      The investigators research will hopefully contribute to a better understanding of how PPL~     can be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular.~     Thus, the results of this project can impart knowledge of great importance both to the~     national and international food industry as well as the healthcare systems.~   "
63336|NCT02228239|"~     The purpose of this study is to evaluate the effect of esketamine compared to placebo on~     driving performance as assessed by the mean difference of standard deviation of lateral~     position (SDLP) from an on-road driving test in healthy participants.~   "
63337|NCT02228226|"~     Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1~     for dislocation of shoulder to evaluate anchor bone hole condition and ossification.~   "
63338|NCT02228213|"~     The purpose of this study is to determine whether MIS416 administered once weekly over 12~     months is safe, tolerable, and improves a range of signs and symptoms associated with~     secondary progressive multiple sclerosis.~   "
63339|NCT02228200|"~     A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting~     was formulated. The aim of the study was to assess the effect of this nurse-led care program~     on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day~     center in terms of quality of life, symptom experiences, self-efficacy, health care~     utilization, and satisfaction with care. Specifically, the objectives are:~        -  To compare the differences of health care utilization between the two arms.~        -  To compare the differences of cancer patients' satisfaction with care between the two~          arms.~        -  To explore the experiences of cancer patients in the intervention arm.~        -  To understand the experiences of the intervention nurses of the program and their~          opinions on further development.~   "
63819|NCT02221947|"~     This study is being done to evaluate the safety, tolerability and potential effectiveness of~     a new investigational drug, bryostatin 1, in patients with Alzheimer's disease (AD).~   "
63820|NCT02221934|"~     The purpose of the clinical trial is to learn whether electrical nerve block is a safe and~     effective treatment for patients with post-amputation pain.~   "
63343|NCT02228148|"~     The purpose of this study is to evaluate if the new and simplified fitting method with~     Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the~     Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing~     outcome as the current and established clinical fitting method with Cochlear Nucleus Custom~     SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass~     and trebles adjustments, operations which are familiar to anyone who has used an audio~     player.~   "
63344|NCT02228135|"~     This is a retrospective chart review looking at the effect of dexamethasone dosing on~     post-tonsillectomy hemorrhage.~   "
63345|NCT02228122|"~     The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on~     chronic wound bacterial biofilms~   "
63346|NCT02228109|"~     The purpose of this study is to use a corneal topographer, a device that is readily~     available in most optometric practices, in order to determine the position of the multifocal~     (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of~     this study is to evaluate if there is a relationship between the positioning of the optics~     of the study lenses and the objective and subjective visual performance as well as~     participant satisfaction. The MF CL lenses will be fitted to two groups of participants~     (previously unsuccessful vs. currently successful MF CL wearers).~      HYPOTHESES~        -  The measurement of the power distribution acquired from the Medmont E300 corneal~          topographer is effective in determining MF CL lens centration and is a predictor of MF~          CL success.~        -  There is a difference in MF CL centration, determined by corneal topography, between~          successful and unsuccessful MF CL wearers.~        -  MF CL centration, determined by corneal topography, is correlated with visual~          performance, determined by ocular aberrometry, measures of visual acuity and subjective~          satisfaction.~   "
63347|NCT02228096|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell~     acute lymphoblastic leukemia, who are chemo-refractory, relapsed after allogeneic SCT, or~     are otherwise ineligible for allogeneic stem cell transplant.~   "
63348|NCT02228083|"~     To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.~   "
63349|NCT02228070|"~     Measuring ocular motility and alignment is important for diagnosing different causes of~     strabismus, following patients recovering from cranial nerve palsies, preparing patients for~     strabismus surgery and follow-up post surgery. The current clinical gold standards for~     measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are~     accurate, but require patient cooperation, and are not objective because the patient has to~     indicate the position of the light he sees on the screen. Our objective is to develop an~     accurate and easy to use goggles system to measure ocular alignment and motility using 3D~     video oculography.~   "
63350|NCT02228057|"~     Injury to the blood vessels of the extremities, and more specifically the arteries, can~     result from fractures and severe crush injuries. It occurs in about 3% of the general~     population. People affected by blood vessel injuries can have important problems, including~     cold intolerance, general pain, and weakened function of the associated limb. Even after~     surgical intervention to repair the affected artery, people may still experience numbness,~     problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are~     particularly relevant in the case of forearm arterial repairs because this repair directly~     affects one of our most vital structures: the hand. Despite available interventions and~     advances in microsurgical technique, arterial repairs can still result in significant~     sensory and functional impairment of the hand. Once an artery within the arm is injured, a~     surgeon's primary goal is to restore blood flow to the hand and prevent functional~     impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6~     months) sensory and motor function is hard to predict.~      Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this~     occlusion has a direct impact on a patient's perceived pain and cold intolerance at the~     level of the hand.~      In this study, we are investigating the occurrence of blood vessel occlusion in the arm~     after at least 6 months of surgery and the impact of this event. To assess this we will use~     physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires.~     Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold~     Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess~     pain, sensory, and motor impairments in both the affected and unaffected hand. Functional~     assessments will include 2-point discrimination, grip strength, pinch strength, capillary~     refill and range of motion.~   "
63351|NCT02228044|"~     This study examines whether an integrated alcohol/substance abuse, suicide, and HIV~     prevention protocol is associated with lower onset and frequency of alcohol and other drug~     use, suicidal behavior, and high risk sexual behavior among adolescents receiving community~     based mental health care.~   "
63352|NCT02228031|"~     The purpose of this project is to investigate the possible effect of intranasally~     administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron~     system (MNS) is thought to be involved in action perception and understanding, and may also~     underlie more complex cognitive processes such as imitation. We will use~     electroencephalographic (EEG) investigations to examine brain activity while participants~     complete two different tasks, consisting of the observation and imitation of emotional~     facial expressions (video presented) and the observation and execution of simple grasping~     actions (live presented), respectively. In addition, before the beginning of the EEG~     recording session, subjects will be randomly assigned to two different groups (Oxytocin or~     Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution.~     Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will~     identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of~     emotion and goal directed action perception and imitation/execution.~   "
63353|NCT02228018|"~     CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested~     in a group of healthy volunteers and asthma patients.~   "
63354|NCT02228005|"~     The purpose of this study is to examine the effects of sertraline treatment of depression in~     older adults on gait stability, balance recovery reactions, and markers of bone metabolism.~     This is a pilot study that will determine feasibility and generate hypotheses for a larger~     definitive study.~   "
63355|NCT02227992|"~     The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant~     Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft~     tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and~     thoracic (non-cardiac) surgery in paediatric patients.~   "
63821|NCT02221921|"~     The objective of this study is to evaluate the safety and effectiveness of the MicroPort's~     Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe~     aortic stenosis who are considered unsuitable for Surgical Valve Replacement.~   "
63356|NCT02227979|"~     The proposed study is designed to investigate whether the PURPLE Crying program attains~     efficacy by optimizing the neural response in the anterior insula, and augmenting activity~     in regions of the brain known to be important for emotion regulation.~      The aim is to determine the effects of the PURPLE Cry Intervention by investigating the~     following:~        -  independent variables that may affect a father's neural response to infant cries~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          reported aversiveness and empathy in response to cry stimuli~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          neural response to unknown infant cries compared to a tone control~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          neural responses to own infant cries compared to unknown infant cries~      The investigators hypothesize:~        -  prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be~          modulated by the following variables: subjective self-reported emotional reaction to~          cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant~          temperament, life stressors, parental expectations, personality (neuroticism), and~          father's own childhood experience~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will report a larger decrease in aversiveness and a larger increase in~          empathy in response to cry stimuli~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will show a larger decrease in activity in the anterior insula and~          amygdala in response to cry stimuli~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will show a larger increase in activity in regions of the brain important~          for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and~          orbitofrontal PFC~        -  fathers' neural activity in the amygdala in response to their own infant's cry stimuli~          will be positively correlated with both their own and infant testosterone levels~   "
63357|NCT02227966|"~     The primary objective of this preliminary study is to investigate whether the transcranial~     direct current stimulation (tDCS) improves the cognitive function in patients with Mild~     Cognitive Impairment (MCI)~   "
63358|NCT02227953|"~     The primary objective of this preliminary study is to investigate whether the transcranial~     direct current stimulation (tDCS) improves the cognitive function in patients with~     Alzheimer's disease~   "
63359|NCT02227940|"~     This phase I trial studies the side effects and best dose of ceritinib and combination~     chemotherapy in treating patients with solid tumors that have spread to other places in the~     body and usually cannot be cured or controlled with treatment (advanced) or pancreatic~     cancer that has spread from where it started to nearby tissue or lymph nodes (locally~     advanced) or has spread to other places in the body (metastatic). Ceritinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle~     formulation, and cisplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving ceritinib and more than one drug (combination chemotherapy) may be a better treatment~     for solid tumors or pancreatic cancer.~   "
63360|NCT02227927|"~     Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux~     disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.~      This is a long-term treatment program for prescription of this drug to all patients who, in~     the investigators' judgement, could benefit from its use.~   "
63361|NCT02227914|"~     The purpose of Phase 1b of the study is to determine the maximum tolerated dose,~     pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and~     activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular~     carcinoma (HCC).~      The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination~     with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects~     with advanced HCC.~   "
63362|NCT02227901|"~     This phase I trial studies the side effects and best dose of tipifarnib when given together~     with radiation therapy and temozolomide in treating patients with newly diagnosed~     glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor~     cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving tipifarnib together with radiation therapy and~     temozolomide may be a better way to treat glioblastoma multiforme.~   "
63363|NCT02227888|"~     This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the~     pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order~     to identify an initial starting dose for Phase 2 trials.~   "
63364|NCT02227875|"~     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily~     (both administered in combination with other anti-diabetic drugs) based on the change in~     HbA1c from baseline to 24 weeks~   "
63365|NCT02227862|"~     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily~     (based on change in HbA1c from baseline to 24 weeks) when administered in combination with~     mealtime insulin lispro.~   "
63366|NCT02227849|"~     The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284)~     in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.~   "
63367|NCT02227836|"~     Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic~     Esophagitis?~   "
63368|NCT02227823|"~     The purpose of this study is to evaluate safety and efficacy of anti-cholinesterase therapy~     on the motor function in SMA type 3 patients with impaired neuromuscular junction (NMJ).~   "
63369|NCT02227810|"~     Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong~     mechanical ventilator (PMV) and is associated with increased rate of weaning failure and~     days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in~     patients with severe chronic heart failure and chronic obstructive pulmonary disease. The~     purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary~     mechanics and hospitalization outcomes in patients with PMV.~   "
63370|NCT02227797|"~     The primary purpose of this study is to identify the optimal dose of voriconazole, an~     anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level~     is one level that provides a good blood level (concentration) of voriconazole without too~     much toxicity.~   "
63371|NCT02227784|"~     The purpose of the ACCENTUATE study is to evaluate whether the study drug known as~     evacetrapib is effective in treating participants with high cholesterol and atherosclerotic~     cardiovascular disease (ASCVD) and/or diabetes.~   "
63372|NCT02227771|"~     The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy~     stent should minimize the risk of late aneurysm formation and potential clinical~     complications but not at the cost of enhanced efficacy.~   "
63373|NCT02227758|"~     The purpose of this study is to evaluate the long-term safety and performance of~     neurostimulation for the treatment of intractable chronic migraine as well as to detect~     infrequent complications or problems only apparent in real-world practice~   "
63374|NCT02227745|"~     Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and~     allows the pigment epithelium remove the intraretinal fluid is effective in reducing the~     incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the~     characteristics of the function can be reduced such as setting (location and stability) are~     relevant to the quality of the patient's vision parameters, reading comprehension,~     especially the ability, duration of diabetic macular edema, could have a significant impact~     on survival and / or the functional reserve of the macular cells subjected to mechanical and~     toxic stress-induced edema. It seems that in the treatment of patients with EMCS,~     photoreceptor damage occurs as a recent phenomenon, and can precede neurodegeneration~     retinal photoreceptor loss, whereby visual function can be decreased. An adjunctive~     treatment as Dorzolamide facilitating effect helping resorption of intraretinal fluid~     through EPR and reduce adverse events that is the loss of contrast sensitivity and retinal~     sensitivity, response time of photocoagulation treatment could be reduced to the patient,~     because the rate of resorption of intraretinal fluid is facilitated and thus the duration of~     the response, also could reduce damage to vision caused by the inadequacies of the~     photoreceptors during the evolution of macular edema avoiding moderate visual loss, there by~     increasing the quality of life in terms of improving the quality of vision in diabetic~     patients. In addition to obtaining a specific adjuvant treatment with photocoagulation is~     helpful for focal edema in diabetic and a new level using dorzolamide in retina Dorzolamide~     as adjunctive therapy after focal photocoagulation is more effective than placebo in~     improving visual function in patients with diabetic macular edema~   "
63375|NCT02227732|"~     The purpose of this study is to determine whether a new catheter is safe and effective in~     treating malignant pleural effusions.~   "
63376|NCT02227719|"~     A single center, randomized, controlled, parallel-arm study is planned to investigate~     clinical outcomes of horizontal ridge augmentation with simultaneous single implant~     placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the~     inclusion criteria will be enrolled. They will be randomly placed into one of two treatment~     groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a~     control. The decision of which material to use will be made after an implant is placed.~     Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after~     which the implants will be surgically uncovered and restored. Outcome analyses will be~     performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from~     the implant surgery. Clinical and radiographic parameters will be compared between the two~     experimental groups. The primary outcome is linear increase of horizontal ridge width from~     direct measurements.~   "
63377|NCT02227706|"~     To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to~     achieve haemostasis during surgery in paediatric patients.~   "
63378|NCT02227693|"~     This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using~     avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver~     disease. This study will assess the effect of avatrombopag on platelet counts in Japanese~     subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count~     measured at Screening and Baseline. Within the lower baseline platelet count cohort (less~     than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg~     avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher~     baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be~     randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag~     for 5 days.~   "
63379|NCT02227680|"~     This project studies the feasibility of (1) implementing massage therapy and music therapy~     onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage~     therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The~     investigators will conduct a randomized controlled trial comparing massage therapy, music~     therapy, and usual care to collect preliminary data on critical outcomes for patients~     (satisfaction, symptom control) and for the hospital (pain medication use and length of~     stay, both critical drivers of cost). The investigators anticipate using these preliminary~     data to apply for a future larger and longer adequately powered randomized controlled trial~     to definitively answer the following research questions: does implementation of an inpatient~     massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce~     symptoms such as pain; and (c) lower health care costs through less pain medication and~     reduced length of stay?~   "
63380|NCT02227667|"~     The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the~     patient and cancer.~      MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the~     body that help fight infections and possibly cancer. MEDI4736 is a special type of an~     antibody produced in a laboratory. MEDI4736 works by blocking a specific protein called the~     Programmed Death Ligand-1 (PDL-1), located on tumor cells.~   "
63381|NCT02227654|"~     The present investigation will prospectively evaluate whether serial transvaginal~     ultrasonography with Morphology Index (MI) can further reduce false positive results by more~     accurately distinguishing benign from malignant ovarian tumors. If there is no change in the~     detection of true positive cases, the result will be an increase in the positive predictive~     value of ovarian cancer screening.~   "
63392|NCT02227511|"~     Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks~     between regular meals for two months. Laboratory tests for cardiovascular risk factors,~     metabolic rate, liver steatosis and physical activity are investigated ahead of start of the~     study and at the end of the trial period och two months. Participants will be allowed to buy~     fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be~     reimbursed for the costs of the snacks.~   "
63401|NCT02227394|"~     This study will be conducted as a randomized, double blind, double dummy two-period~     crossover study in stable asthma patients treated in accordance with the Global Initiative~     for Asthma (GINA) guidelines, will be included.~      The primary objective of this study is to evaluate the effect of the products under~     investigation on Functional respiratory imaging parameters and evaluate the particle~     deposition with Computational fluid dynamics (CFD).The secondary objectives of this study~     are to assess the effect of Z7200 and Symbicort® on lung function (spirometry and body~     plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS~     dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated~     through monitoring of adverse events throughout the study.~   "
63382|NCT02227641|"~     In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses~     such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life~     threatening complication requiring antiviral treatment. The underlying problem is a severe~     suppression of the donors immune system after transplantation into the patient.~     Herpesviruses such as CMV and EBV persist after primary infection life long in the host and~     therefore require constant immunological control. This control is largely provided by the~     T-cell compartment of the immune system. After allogeneic stem cell transplantation the~     T-cell compartment requires a long time for its reconstitution since only a small fraction~     of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the~     lack of effective T-cell control.~      This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific~     T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a~     phase I study to demonstrate that these in vitro generated T-cells can be applied safely in~     this patient population. The study also aims at demonstrating the efficacy of CMV/EBV~     specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis~     is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus~     host disease and that they successfully prevent reactivation of CMV and EBV after adoptive~     transfer in patients after allogeneic stem cell transplantation.~   "
63383|NCT02227628|"~     A human clinical consumption trial will be performed in volunteers with increased risk~     factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes~     and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4,~     8, and 12 weeks and a 24 hr urine collection on each blood draw day.~   "
63384|NCT02227615|"~     The objective of this research is to characterize the urinary metabolites produced after the~     consumption of mango pulp in an effort to begin to characterize the bioavailability of the~     major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight~     into their in vivo physiological behavior.~   "
63385|NCT02227602|"~     Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has~     been demonstrated in animals and humans. However, the efficacy of mangoes has not previously~     been compared with respect to mild inflammatory bowel disease. In order to justify future~     pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to~     determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary~     step. Therefore, in this aim we will determine the clinical relevance of mango as an~     adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of~     mango with common drug treatment in mild-moderate Inflammatory bowel disease will be~     compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be~     identified as helpful in shortening or reducing severity of episodes of inflammatory bowel~     disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel~     disease would have a significant impact on public health.~   "
63386|NCT02227589|"~     The investigators will recruit adolescents with alcohol or cannabis abuse and clinically~     significant depression. All participants will receive 12 sessions of an evidence-based~     treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12,~     over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to~     receive treatment augmentation with either an integrated cognitive behavior therapy for~     depression, delivered by their study therapist, or depression treatment-as-usual in the~     community. The study hypothesis is that integrated depression treatment will surpass~     community treatment-as-usual in efficacy.~   "
63387|NCT02227576|"~     Chemotherapy used in the treatment of primitive tumors of the central nervous system has a~     particularly important platelet toxicity compared to chemotherapy used for treatment of~     other tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The~     TP and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or~     induced (Gerber, 2006) can have dramatic consequences:~        -  specifically neurological (intratumoral bleeding with particularly important~          neovascularization) with a functional aggravation and sometimes involvement of vital~          prognosis,~        -  digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with~          corticoids (potential gastric toxicity).~      The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients~     with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9,~     8%), has changed the standard of care of these patients (Stupp et al., 2009). Patients with~     newly diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5~     days per week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg~     per square meter of body-surface area per day, 7 days per week from the first to the last~     day of radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg~     per square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the~     treatment of reference for glioblastoma and is used as a basis in various clinical studies~     with new agents.~      This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ~     chemotherapy of glioblastomas.~   "
63388|NCT02227563|"~     The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on~     auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the~     left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral~     prefrontal cortex.~   "
63389|NCT02227550|"~     Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor~     apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing~     catheter ablation of non-valvular AF in the prevention of peri-procedural complications.~      The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational~     treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial~     fibrillation (AF).~   "
63390|NCT02227537|"~     A multicenter, prospective, non-randomized, single-arm observational study evaluating the~     Providence nighttime bracing system in patients diagnosed with adolescence idiopathic~     scoliosis.~   "
63391|NCT02227524|"~     In this study, the investigators will examine a sample of persons with multiple sclerosis~     (MS) to determine whether their walking function and ability is different depending on which~     walking assistive device is used.~   "
64852|NCT02208453|"~     The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device~     implantation in a surgical procedure under local anesthesia using arthroscopic and/or~     fluoroscopic visualization of the affected shoulder.~   "
63393|NCT02227498|"~     The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with~     severe age-related macular degeneration (AMD). The Argus II System has already been studied~     in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of~     the retina are irrevocably damaged and the Argus II System has been found to restore some~     basic visual function. On these grounds, the device has received authorization for use on~     the European market (the CE certification) in 2011.~      In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with~     the Argus II System. The study will evaluate the safety of the device and surgery, as well~     as functioning of the system and the extent of any restored vision. Each subject will be~     followed for 3 years, with their eye health and visual function tested at multiple time~     points.~   "
63394|NCT02227485|"~     This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian~     traditional mouth rinse (Punica granatum Pleniflora or Golnaar mouthrinse) on treatment of~     diabetic gingivitis and compare it with chlorhexidine (0.2%).~   "
63395|NCT02227472|"~     Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of~     the impact the disease can have on the central nervous system. Specific impairments in~     working memory are particularly prevalent in school-aged children with SCD. Working memory~     is more strongly associated with school readiness and academic success than intellectual~     ability in the general population. The adverse effects of low socioeconomic status (SES) and~     poverty on cognition and neurodevelopment emerge early, before children have entered formal~     education. In addition, they affect language and executive function skills (e.g., working~     memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES~     is associated with less parental stress, more supportive parenting practices, and better~     cognitive stimulation based on the availability of books, computers, and outings.~      PRIMARY OBJECTIVE:~        -  To examine working memory and school readiness in young children with sickle cell~          disease in comparison to demographically matched control children without sickle cell~          disease.~      SECONDARY OBJECTIVE:~        -  To examine the relationships of family/environmental factors (caregiver stress,~          parental responsiveness, and cognitive stimulation in the home) and disease severity to~          working memory and school readiness skills in preschool-aged children with SCD.~   "
63396|NCT02227459|"~     The purpose of this study is to evaluate the safety and tolerability of multiple doses of~     ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.~   "
63397|NCT02227446|"~     The Vancomycin Study is a multi-center, prospective randomized controlled trial that will~     compare the proportion of deep surgical site infections within 6 months in patients treated~     with local Vancomycin powder compared to those treated without local Vancomycin powder at~     the time of fracture fixation.~   "
63398|NCT02227433|"~     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and~     safety of BV as a single agent in elderly patients at first relapse or with primary~     refractory HL.~      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of~     anti-cancer activity will be assessed using the revised response criteria for malignant~     lymphoma (Cheson et al. 2007).~      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at~     baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be~     done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT)~     assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up~     assessments (including survival and disease status information) will be performed every 12~     weeks until either patient death or study closure, whichever occurs first. Patients who~     discontinue study treatment with stable disease or better will have CT scans done every 12~     weeks until disease progression.~      Study Objectives~      Primary:~      • To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg~     administered intravenously every 3 weeks) as measured by the overall objective response rate~     in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).~      Secondary:~        -  To assess duration of tumor control, including duration of response and~          progression-free survival~        -  To assess survival~        -  To assess the safety and tolerability of BV~      Additional:~      • To assess disease-related symptoms Study Population Eligible patients are those with first~     relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed~     CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5~     cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate~     hematologic, kidney, and liver function. Eligible patients must not previously have been~     treated with BV, patients must not have congestive heart failure, known cerebral/meningeal~     disease, or any active viral, bacterial, or fungal infection requiring treatment with~     antimicrobial therapy within 2 weeks prior to first study dose.~   "
63399|NCT02227420|"~     In obese individuals cortisol production and secretion is increased but the underlying~     mechanism is not known. Obesity leads to a pathological activation of the innate immune~     system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to~     stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators~     hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby~     explaining the observed hypercortisolism.~   "
63400|NCT02227407|"~     Ambulation would bring many physiological and psychological benefits and getting up and~     walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for~     paraplegics particularly draws research attentions because it mimics human gait pattern.But,~     the high energy consumption and low walking speeds caused the frequent abandonment or the~     low utilization of the reciprocating gait orthoses.To improve the design reducing the energy~     expenditure, it requires biomechanical analysis of the pathological gait such that the gait~     deviations and energy consuming mechanisms can be identified and remedial means can be~     implemented.~      The investigators hypotheses will include that there would exist an energy saving mechanism~     of human reciprocating locomotion based on the principle of conservation of mechanical~     energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy~     saving mechanism. Finally, the control of knee joint coordinating with the hip joint~     movements would facilitate the gait progression and further reduce the energy consumption.~      The objective of this clinical trial is to evaluate the gait of paraplegic patients with~     reciprocating gait orthoses and to support the investigators research in biomechanical~     analysis, design and control of reciprocating gait orthoses for paraplegia patients. An~     experiment to study the pathological gait of paraplegia patients with an existing~     reciprocating gait orthosis will be carried out.~   "
63438|NCT02226913|"~     Buffering of local anesthetics (alkalinization) has been suggested in achieving pain~     control. The purpose of this prospective, randomized, double-blind study was to evaluate the~     effect of adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000~     epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars~     with symptomatic irreversible pulpitis.~   "
64885|NCT02208024|"~     The purpose of this study is to test the safety of focused radiation (Stereotactic Body~     Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.~   "
63402|NCT02227381|"~     Learning disability affects 3% of the population. Severe types of learning disability are~     more likely to have an underlying genetic cause but diagnosis is difficult because many~     different genetic abnormalities may be involved. Obtaining a diagnosis is important so that~     patients can be managed appropriately and their families can be given accurate information.~      We aim to use new types of genetic testing which will make it possible to screen for several~     different genetic abnormalities which cause learning disability at the same time, so~     improving the accuracy and speed of diagnosis in the group of patients with severe learning~     disability. We will focus particularly on patients where seizures and behavioural problems~     are also present.This will enable more patients to be diagnosed accurately, reduce the~     number of hospital appointments needed and ultimately be more cost- effective.~   "
63403|NCT02227368|"~     To compare the effect of ticagrelor versus aspirin on the change in peak walking time,~     evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in~     patients with peripheral artery disease who have undergone endovascular revascularization~     for moderate to severe claudication or ischemic rest pain.~   "
63404|NCT02227355|"~     This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy~     for younger and older patients with Parkinson's Disease under real life conditions. Effects~     on ability to perform activities of daily living, sleep, medication dose and other factors~     will be assessed.~   "
63405|NCT02227342|"~     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for~     IBD patients. Studies are now required to determine if repeated FMT can overcome the~     apparent immune response to FMT thereby maintaining sustained clinical improvement and~     remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a~     feasibility study to determine if serial FMTs can sustain a clinical response and maintain~     stability of transplanted microbiota.~   "
63406|NCT02227329|"~     This study is being implemented to identify the role of prophylactic use of ethanol lock in~     adult patients on home parenteral nutrition (HPN). Central catheter related blood stream~     infection is a major complication in patients on HPN. The investigators hypothesize that the~     prophylactic use of ELT will decrease the number of catheter related blood stream infections~     compared to the control group. The investigators further hypothesize that with the~     introduction of prophylactic ELT, the number of infections will decrease. This will improve~     the quality of life (assessed using Questionnaire) in HPN patients.~   "
63407|NCT02227316|"~     The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy~     menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.~     Post UFE procedural pain and nausea are expected events. These symptoms are treated with~     current standard of care medications, including opiates.~      Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers~     include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV~     ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled~     analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post~     procedure nausea control medications include a transcutaneous scopolamine patch and IV~     anti-nausea medications such as ondansetron and prochlorperazine.~      This study is being conducted to compare two new medications for pain, IV ibuprofen and IV~     acetaminophen, administered for 24 hours following UFE. The primary safety objective of~     non-inferiority will be met and the primary efficacy objective of superiority, decreased~     pain and nausea, will be accessed when compared to current standard of care regimens.~      This is a 4 arm, double blind, randomized, controlled study. All patients will receive~     standard of care baseline pain medications, including IV midazolam, fentanyl and~     hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure.~     The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV~     placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These~     medications will be given during the procedure and extended over a 24 hour stay.~      Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will~     include IV push (IVP) ketorolac, which would be given at the end of the procedure and be~     continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control~     every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at~     intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.~   "
63408|NCT02227303|"~     The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient~     Cloud (a mobile application for capturing data directly from subjects, enabling entry of~     diary and quality of life data into internet-enabled devices) in combination with an~     activity tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.~   "
63409|NCT02227290|"~     The study is being done to see how well the study cream works when applied once a day to~     affected area of child (where they have ringworm). The results will be compared to those~     seen with a placebo cream which has no active ingredient. Safety of the cream will also be~     measured.~   "
63410|NCT02227277|"~     The purpose of this study is to determine if treatment with pegylated interferon alpha 2b~     (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and~     tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).~      A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant~     in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV~     eradication.~      By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate~     measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment~     should be considered as a component of future viral eradication strategies.~   "
63411|NCT02227264|"~     Patients with primary hyperparathyroidism (pHPT) often present with fatigue, psychological~     and cognitive symptoms. Improvement in these symptoms after parathyroid adenomectomy (PTX)~     has been reported. But physicians lack a method to attribute the symptoms to pHPT and to~     predict the reversibility after PTX.~      This study aims to evaluate short-term calcimimetic treatment as a tool for predicting the~     outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive~     function in patients with pHPT.~      Material and Methods: 118 patients scheduled for PTX at Karolinska University Hospital,~     Sweden, will have a four week treatment with calcimimetics (Mimpara®) before undergoing~     surgery. Biochemicals, muscle strength, quality of life, psychological symptoms and~     cognitive function will be analysed at baseline, after four week follow-up and~     postoperatively.~      Hypothesis: The outcome of short-term calcimimetic treatment can predict the outcome of PTX~     on muscle strength, quality of life, psychological symptoms, and cognitive function in~     patients with pHPT~   "
63412|NCT02227251|"~     Randomized two-arm, multicenter, open-label Phase 2b study of 2 doses of selinexor (KPT-330)~     high in patients with relapsed/refractory de novo DLBCL who have no therapeutic options of~     demonstrated clinical benefit.~   "
63439|NCT02226900|"~     This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid~     myocardial revascularization strategy (coronary artery by-pass graft and percutaneous~     intervention) in comparison with conventional surgical coronary bypass grafting.~   "
63413|NCT02227238|"~     For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend~     to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse~     transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase~     inhibitors (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for~     further data on the best treatment options for people with HIV-1 who have virological~     failure with this first-line regimen. The number of patients failing on their first-line~     regimen is increasing thereby requiring a switch to second-line treatment to reduce~     accumulation of drug-resistance mutations, disease progression, HIV transmission, and death.~     WHO guidelines recommend second-line antiretroviral therapy for adults consisting of two~     NRTIs + a ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV)~     or lopinavir (LPV)/RTV are the preferred boosted PI options. This study is conducted to~     demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing~     regimen compared to a WHO-recommended standard of care regimen for second line treatment,~     LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy. This study~     comprises of a Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to~     Week 48 plus a 4-week treatment extension), and a Continuation Phase. Approximately 612~     subjects will be randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV~     (800/200 mg once daily or 400/100 mg twice daily, in accordance with investigator decision~     and local label), each added to an investigator selected background regimen of two NRTIs at~     least one of which needs to be fully active based on viral resistance testing at Screening.~     Subjects randomized to receive DTG who successfully complete 52 weeks of treatment will~     continue to have access to DTG until it is either locally approved and commercial supplies~     are available to patients or the patient no longer derives clinical benefit, or the patient~     meets a protocol-defined reason for discontinuation.~   "
63414|NCT02227225|"~     Postoperative delirium has been found to be associated with increased risk of future~     neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has~     been found to be associated with an increased risk of postoperative complication including~     delirium in the elderly.The purpose of this study is determine the factors affecting the~     incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the~     Singapore population.~   "
63415|NCT02227212|"~     Primary Objective:~      To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type~     2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.~      Secondary Objectives:~      To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and~     insulin-naïve T2DM patients.~      The safety and usability of the U300 pen injector. The glycemic control with the U300 pen~     injector. The safety of HOE901-U300.~   "
63416|NCT02227199|"~     This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can~     be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin~     lymphoma that has come back (relapsed) or is not responding to treatment (refractory).~     Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in~     different ways by targeting certain cells. Drugs used in chemotherapy, such as ifosfamide,~     carboplatin, and etoposide, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving brentuximab vedotin together with an ifosfamide, carboplatin, and~     etoposide chemotherapy regimen may kill more cancer cells.~   "
63417|NCT02227186|"~     Children in schools in which influenza vaccination clinics are held during school hours will~     have higher rates of influenza vaccination than children in control schools (no~     school-located clinics offered)~   "
63418|NCT02227173|"~     This is an open-label, single-sequence, drug-drug interaction study in healthy male and~     female subjects. There is no formal research hypothesis to be statistically tested. It is~     expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may~     increase the exposure of montelukast, flurbiprofen, and digoxin.~   "
63419|NCT02227160|"~     The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial~     with low-income African American suicide attempters. Guided by the Theory of Triadic~     Influence (TTI), this pilot randomized controlled trial aims:~        1. to determine if psychosocial group intervention (PGI) is more effective than enhanced~          treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary~          outcome) and improving its correlates (depressive symptoms, hopelessness, quality of~          life) (secondary outcomes) in low-income African Americans with a recent attempt.~        2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I),~          social/situational (SS), and cultural/environmental (CE) risk and protective factors~          that mediate the condition-suicidal behavior and correlates link and thus serve as~          mechanisms of change.~        3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link~          and thus serve as predictors of intervention outcome.~      Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence~     greater improvements in suicidal behavior and its correlates than those in ETAU.~      Hypothesis for Aim 2: Changes in these risk and protective factors will account for~     condition effects on outcomes: (1) psychological distress, aggression, impulsivity,~     substance abuse, low self-esteem, and suicide acceptability (I-risk); (2) perceived~     burdensomeness and thwarted belongingness, relationship discord, intimate partner violence~     perpetration and victimization (SS-risk); (3) access to a weapon and barriers to service~     utilization (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective~     coping, and spiritual well-being (I-protective); (5) overall family health and social~     support from family and friends (SS-protective); and (6) religious involvement and~     effectiveness of obtaining resources (CE-protective).~      Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of~     Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward~     the self and others (I); (2) children and more limited trauma histories (SS); and (3) more~     daily hassles and less exposure to community disorder (CE) will evidence greater reductions~     in suicidal behavior and its correlates and greater enhancements in quality of life at~     post-intervention and follow-up.~   "
63420|NCT02227147|"~     The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of~     rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle~     (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is~     intended as:~        -  complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)~          neurotrophic keratitis (NK) as measured by the central reading center using corneal~          fluorescein staining,~        -  assessing the duration of complete healing,~        -  improvement in visual acuity and improvement in corneal sensitivity.~   "
63421|NCT02227134|"~     This is a prospective study to see whether ultrasonography can predict difficult airway~     and/or predict obstructive sleep apnea syndrome (OSAS) in children.~   "
63422|NCT02227121|"~     The proposed study is designed to characterize defibrillation efficacy in humans for the~     potential development of a new extravascular implantable cardioverter defibrillator (ICD)~     system.~   "
63423|NCT02227108|"~     The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in~     pediatric subjects with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma~   "
63503|NCT02226068|"~     Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring~     systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven~     but potential side effects are concerning. Several reports point at extracorporeal~     photopheresis (ECP) as an efficient alternative treatment modality with few and mild side~     effects. However, no direct comparison between CsA and ECP in the treatment of AD has been~     performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard~     treatment with CsA.~   "
63424|NCT02227095|"~     This research focuses on overweight, sedentary children whose health, cognition, and~     academic performance are therefore at risk, and who may be particularly responsive to~     exercise interventions.~      This study will determine whether regular exercise per se (i.e. compared to attention~     control, or placebo, condition) benefits children's cognition and achievement, and will~     provide insight into neural mechanisms. A substudy will examine exercise-induced changes in~     brain structure.~      Provision of comprehensive evidence for the benefits of exercise on children's health may~     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic~     by persuading policymakers, schools and communities that time spent in physical activity~     enhances, rather than detracts from, learning.~   "
63425|NCT02227082|"~     The majority of breast cancer patients receive radiotherapy as part of their treatment.~     Radiotherapy improves both locoregional control and overall survival. In most patients with~     breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are~     found in certain patient groups, especially in locally advanced, inflammatory and triple~     negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug~     for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and~     radiotherapy. The combination of olaparib and radiotherapy is expected to improve~     locoregional control and thereby overall survival in both breast cancer patients with a high~     probability of locoregional recurrence and patients with HR deficient tumors. However, this~     combination treatment has never been tested in humans before. The purpose of this study is~     to determine the safety and tolerability of radiotherapy to the breast and regional lymph~     nodes with concurrent olaparib.~   "
63426|NCT02227069|"~     This is a single center, randomized, controlled, within-subject comparison, multiple dose~     study to determine the irritation potential of M518101 on normal skin under occlusive patch~     condition.~      The study drug will be applied for 21 days under occlusive patch condition. The irritation~     potential of M518101 will be compared with positive, negative control and M518101 vehicle.~     The study duration is 21days and there will be at least 23 visits to study center including~     screening visit.~   "
63427|NCT02227056|"~     The purpose of this study is to investigate the influence of Methylphenidate in pediatric~     acquired brain injury population, regarding ecologic (every day) function. It is~     hypothesized that the function with treatment will improve when compared to function without~     treatment in the same patient. Improvement is expected by shortening time of execution in~     each specific task and by reduction of the amount of assistance needed.~   "
63428|NCT02227043|"~     The investigators will study the influence of fat cell size/number and adipose function on~     weight development over very long time periods (years). By comparing fat biopsies obtained~     at baseline and after >7 years, the investigators will determine the association between~     adipose morphology/function and changes in weight or development of cardiometabolic~     complications (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).~   "
63429|NCT02227030|"~     Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL~   "
63430|NCT02227017|"~     Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg~     coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg~     coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted~     and fed conditions in healthy male and female volunteers.~   "
63431|NCT02227004|"~     Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to~     safety concerns. Recent work in our laboratory as well as our pilot study of approximately~     500 patients has shown the safety of most contemporary implanted rhythm management devices~     in the MRI environment given appropriate precautions. Because the investigators have~     completed testing in animals weighing as little as 80 lbs. without incident, the~     investigators feel they can safely image children at this weight or greater (Circulation~     2004; 110:475-482).~      The goal of this study is to expand on our pilot study and to develop a protocol, consistent~     with the DHHS requirements, that will increase our safety experience with clinically~     indicated MR imaging in patients with implanted cardiac pacemakers and ICD's.~      This is a cohort study. One thousand seven hundred patients with a clinical need for MRI~     will be recruited. Risks and Benefits associated with MR imaging in the setting of~     implantable devices will be discussed and informed consent obtained. The type of device and~     leads will be ascertained. Patients will be monitored by a physician or a RN with ACLS~     certification and familiarity with ICD/Pacemaker programming during the study. When imaging~     children who meet age and weight criteria, a physician will be present during the entire~     study. Fellow and attending radiology and electrophysiology support will be available in~     house in all cases.~      Standard device testing including battery voltages, thresholds, sensing and lead impedances~     will be measured.~   "
63432|NCT02226991|"~     Study to investigate the effects of steady-state Efavirenz (600 mg QD) on the steady-state~     pharmacokinetics of Tipranavir (500 mg BID) coadministered with Ritonavir (200 mg BID)~   "
63433|NCT02226978|"~     Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a~     prodrug of aciclovir (ACV)~   "
63434|NCT02226965|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a~     multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize~     anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r)~     diffuse large B-cell lymphoma.~   "
63435|NCT02226952|"~     Study to assess the antiviral efficacy, pharmacokinetics and tolerability of BILN 2061 ZW in~     a polyethyleneglycol 400 (PEG 400: ethanol) drinking solution given for two days bid in~     patients with chronic Hepatitis C Virus (HCV) infection.~   "
63436|NCT02226939|"~     Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN~     2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for~     two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection~   "
63437|NCT02226926|"~     Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with~     healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin~     Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein~     (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma~     levels~   "
97101|NCT01786044|"~     The purpose of this study is to assess the effects of an interactive educational program~     delivered through a patient portal on patients' medication knowledge and medication~     adherence.~   "
63440|NCT02226887|"~     Design Prospective , randomized, parallel phase IV.~      Objectives Main objective~        -  Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of~          incisional hernia of the abdominal wall at the site of a loop ileostomy when it is~          closed  to rebuild the intestinal transit. The effectiveness evaluation is done by~          tracking with scheduled patient visits for 12 months, assessing the physical~          examination the presence or absence of an incisional hernia and an abdominal tomography~          at the end of the 12 months .~      Secondary objectives Comparison of complications(morbidity and mortality) to assess safety~     and tolerability of the placement of the mesh described .~   "
63441|NCT02226874|"~     Background:~      - The National Cancer Institute was funded to study how much radiation U.S. veterans who~     served in the 1950s were exposed to. Researchers want to estimate how much radiation these~     veterans received. They will use two methods and compare them. One is to interview the~     veterans and study their military records. The other is to take blood samples and look for~     certain types of changes in the blood cells. Being exposed to some kinds of radiation is~     known to cause changes in blood cells. The amount of changes to these cells tells scientists~     about how much radiation was received.~      Objectives:~      - To better understand how to measure how much radiation a person has received.~      Eligibility:~        -  Veterans who were exposed to radiation at a specific site in the Pacific in 1954 or~          other sites in the 1950s.~        -  Veterans close in age to the first group, who have low levels of exposure to radiation.~        -  Men about 25 years old with no exposure to radiation.~      Design:~        -  Participants will have 1 visit, in their home.~        -  All participants will have blood drawn. This will take 10 minutes.~        -  The exposed veterans will be interviewed. They will answer questions about the nuclear~          events they experienced. This will take up to 40 minutes.~        -  For the exposed veterans, researchers will look at their military records, if they can.~          They will estimate how much radiation the veteran received.~   "
63442|NCT02226861|"~     Background:~      - Stem cell transplantation from a partially matched donor can lead to graft-versus-host~     disease (GVHD). Researchers want to learn how to improve these transplantations.~      Objective:~      - To see if very low doses of Interleukin-2 after a partially matched transplantation~     prevent GVHD.~      Eligibility:~        -  Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an~          available family member with partial tissue match.~        -  Donors: age 18 80.~      Design:~        -  Recipients will be screened with medical history, physical exam, and many tests~          including blood and tissue tying.~        -  Donors will be screened with medical history, physical exam, blood tests and tissue~          typing.~        -  Recipients will stay in the hospital 3 6 weeks.~        -  All participants will have apheresis. Blood is drawn from one arm, run through a~          machine that collects white blood cells, then returned into the other arm.~        -  Recipients will have:~        -  Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout~          transplant and recovery. They may also have a catheter inserted for collecting immune~          cells.~        -  Bone marrow sample taken by needle. They will have 3 more after transplant.~        -  Donors will have:~        -  Filgrastim injected once daily for 5 6 days.~        -  Stem and immune cells collected by another apheresis.~        -  Recipients will get:~        -  Eight 30-minute doses of radiation, sitting at a machine.~        -  Donor immune cells by IV, 6 days before the transplant day.~        -  Chemotherapy drugs by IV.~      <TAB><TAB>- Donor stem cells by IV on transplant day.~        -  After transplant, recipients will give self-injections of very low doses of~          Interleukin-2 once daily for about 12 weeks.~        -  Before and after transplant, recipients will get medicine to suppress the immune system~          and antibiotics to prevent infections~        -  Recipients must stay near NIH for 3 6 months after transplant.~        -  All recipients and donors will have 3 years of follow-up.~   "
63443|NCT02226848|"~     Background:~      - Traumatic brain injury (TBI) injures blood vessels in the brain. Endothelial progenitor~     cells (EPCs) help the body form new blood vessels. The drug erythropoietin (EPO) helps the~     body make more blood cells and might help make blood vessels. Researchers want to see if EPO~     helps people with TBI.~      Objective:~      - To see whether erythropoietin increases the number of endothelial progenitor cells~     circulating in the blood and changes reactivity of brain vessels.~      Eligibility:~      - Adults age 18 70 who had a TBI 3 7 days ago and still have symptoms.~      Design:~        -  Participants will be screened with medical history and blood tests. Vital signs will be~          taken.~        -  Visit 1:~        -  Medical history, physical exam, and blood sample.~        -  Neuropsychological tests of memory, attention, and thinking. These include written and~          spoken questions, tests on paper or computer, and simple actions.~        -  Magnetic resonance imaging (MRI) scan with carbon dioxide. Participants will lie on a~          table that slides in and out of a metal cylinder. For part of the scan, participants~          will wear a breathing mask like a snorkel and wear a nose clip.~        -  Study drug or placebo injection under the skin of the arm, leg, or buttock.~        -  Visits 2, 3, and 4 will be 1 week apart.~        -  Blood sample.~        -  Review of TBI symptoms and any drug side effects.~        -  Study drug or placebo injection under the skin.~        -  Visit 5 will be 1 week after visit 4. Visit 6 will be 6 months after participants start~          the study.~        -  Blood sample.~        -  Review of TBI symptoms and any drug side effects.~        -  Neuropsychological tests.~        -  MRI with carbon dioxide.~   "
63444|NCT02226835|"~     Background:~      - Alzheimer s disease affects the brain and causes memory and thinking problems in older~     people. Macular degeneration (MD) is an eye condition. It is the leading reason that people~     over age 55 in the United States lose their central vision. Central vision is important for~     seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease~     is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye.~     Researchers want to learn more about these diseases and find out if they are related.~      Objective:~      - To see whether there is a relationship between Alzheimer s disease and age-related macular~     degeneration.~      Eligibility:~      - People with or without Alzheimer s disease enrolled in another study. Participants must~     have someone to help them take part in this study.~      Design:~        -  Participants will be screened through the other study. They will have 1 visit. The~          tests will take about 3 hours.~        -  Participants will answer questions about their medical and eye history.~        -  Participants will have an eye exam to test how well they see. Their eye pressure will~          be measured and their eye movements will be checked.~        -  Participants will get eye drops to dilate their pupils. Researchers will take pictures~          of the retina and the inside of the eye. Researchers may measure the thickness of the~          retina.~        -  Participants will continue to receive care from their regular eye doctor during and~          after the study.~   "
63445|NCT02226822|"~     This study is intended to prospectively research the treatment reality and long-term disease~     control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line~     anti-diabetes treatment in sites across Japan.~   "
63822|NCT02221908|"~     The goal of this study is to assess decision making skills of emergency physicians when~     dealing with hypotensive patients. The hypothesis is that decisions made based on physical~     exam and vital signs regarding fluid resuscitation by emergency physicians are not~     statistically equivalent to those that would be made based on the use of a non-invasive CVP~     measurement~   "
63446|NCT02226809|"~     Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is~     a source of complications, mainly respiratory. The incidence is variable due to multiple~     factors. In Spain the incidence is unknown.~      The investigators hypothesize that a number of patients in the postanesthesia care unit~     (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular~     block agents (NMBA).~      The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary~     objectives are to observe the possible relationship with other pre- and intraoperative~     factors.~   "
63447|NCT02226796|"~     We hypothesize patients who have difficulty with word recall (naming pictures) due to a~     stroke will experience greater benefit in word recall after receiving a combination of~     transcranial direct current stimulation (tDCS) and traditional behavioral treatment. This~     study will investigate the effects of the timing of tDCS in relationship to the behavioral~     treatment to determine the most optimal protocol. Transcranial direct current stimulation~     involves placing two electrodes on your scalp and sending a very small electrical current to~     excite the brain cells of the target site.~   "
63448|NCT02226783|"~     Study to evaluate the effect of intake of food in comparison to fasting condition on~     pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet~     formulation~   "
63449|NCT02226770|"~     The aim of the present study is to measure heart-focused anxiety, general anxiety,~     depression, PTSD and quality of life as well as type D personality in patients with heart~     failure before and after the implantation of a cardioverter defibrillator (ICD) and/or~     assist device (AD).~   "
63450|NCT02226757|"~     This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on~     standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2~     expression, patients can participate in the trial after obtaining informed consent.~      Patients will be treated with weekly paclitaxel-trastuzumab.~   "
63451|NCT02226744|"~     Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow~     breathing techniques to induce physiological and mental relaxation. Medical research~     suggests that slow breathing techniques induce physiological relaxation. This 6 week study~     will compare the effects of different types of breathing. The hypothesis is that different~     breathing techniques produce different physiological and mental changes.~   "
63452|NCT02226731|"~     The purpose of this study is to evaluate the impact of early intrauterine tamponade with a~     Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal~     delivery and refractory to first-line uterotonic treatment, ie performed at the same time as~     second line uterotonic treatment, as compared tolate intrauterine tamponade performed in~     case of failure of second line uterotonic treatment, on the final severity of PPH. ).~   "
63453|NCT02226718|"~     For measuring quality of life in patients with chronic inflammation of the middle ear, only~     two questionnaires currently exist. However, these questionnaires are designed only to~     measure either disease-specific health or hearing-related quality of life. The aim of this~     project is the validation of a pre-existing comprehensive questionnaire, which is routinely~     administered in the investigators clinic but has never been validated. Following a~     retrospective item reduction based on existing data, this questionnaire will be~     prospectively validated. Applying the resulting questionnaire in future studies on chronic~     middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also~     quality of life will be assessed. Therefore, the investigators questionnaire will add~     substantial information to these outcome studies by providing a subjective outcome~     parameter.~   "
63454|NCT02226705|"~     Radical endoscopic transnasal surgery associated with medical treatment with liposomal~     amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the~     survival rate. The objective of this study is to evaluate the local control rate and~     survival rate at 3 months after radical endoscopic transnasal surgery extended towards the~     skull base in association with antifungal therapy and early surgical reevaluation of the~     extent of the disease.~   "
63455|NCT02226692|"~     The aim of the present study is to quantify the relative contribution of variables obtained~     during a physical fitness evaluation and a short screening questionnaire in determining the~     short-term and long term risk of persistent disabling low back pain in patients with chronic~     low back pain. It has been hypothesized that patients with higher physical fitness will~     present a lower risk of persistent disabling low back pain and so, a lower score on the~     questionnaire.~   "
63456|NCT02226679|"~     The objective of this extension study is to evaluate the safety and potential beneficial~     effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a~     dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the~     long-term safety and effectiveness of the Algisyl-LVR in patients with established heart~     failure.~   "
63457|NCT02226666|"~     The purpose of this study is to prospectively compare the physiologic response of patients~     who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine~     (MultiHance).~   "
63458|NCT02226653|"~     The purpose of this study is to determine if two different dosing strategies for evacetrapib~     will have essentially the same effect on the body. The study will also explore the effect of~     a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,~     not including screening. Screening is required within 28 days prior to the date of first~     dosing.~   "
63459|NCT02226640|"~     This is a study to identify different subtypes of type 2 diabetes. The investigators will~     look for information at the molecular level, which may lead to personalized diagnosis and~     therapies.~   "
63477|NCT02226406|"~     In the critically patient bed rest and immobilization are some of the responsable of the~     development of respiratory complications. Early physical exercise is a tool to prevent~     respiratory complications as lost of respiratory muscle strength, decrease in functional~     residual capacity and hypoxemia improving oxygenation.~      New technology as electrical impedance tomography (EIT) are available to visualize changes~     of regional lung aeration.~      The aim of this study is to assess the effect of early physical exercise improving alveolar~     recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with~     EIT.~      The ICU patients included at day of evaluation will be evaluated continuously with EIT in~     different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair~     3) Active physical exercise 4) And rest in chair after exercise~   "
63460|NCT02226627|"~     This study aims to make a proper scientific assessment on the dietary intake and physical~     activity levels of a representative sample of the urban population of 8 Latin American~     countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The~     study was based on complex, multistage sample design, stratified by conglomerates, being all~     regions of each country represented, and random selection of main cities within each region~     according to probability proportional to size method. Sample will be stratified by gender,~     age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and~     divided in three strata (high, medium and low) based on national indexes used in each~     country. All the study sites are university-based and will adhere to a common study protocol~     for training, implementation of fieldwork, data collection and management, and quality~     control procedures to be performed simultaneously. All participants will be required to~     provide a written informed consent. A pilot study at small scale will be performed in each~     country in order to test procedures and tools involved in ELANS. Anthropometric variables,~     including body weight, height, waist, hip and neck circumferences will be measured according~     to a standardized protocol. Nutritional intake evaluation will be performed using two~     24-hour dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.~     Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota~     University) after a harmonization process between local foods and NDSR database. Physical~     activity and energy expenditure will be assessed by IPAQ-long version questionnaire and~     7-day accelerometry.~   "
63461|NCT02226614|"~     This study is testing a head-cooling device on volunteers to assess temperature reduction.~   "
63462|NCT02226601|"~     Morphine and similar substances (called opioids) are often prescribed for moderate to severe~     pain, such as after a surgery, thus allowing for minimal pain and a better recovery.~     Unfortunately various, non-dangerous side effects from opioids occur often that limit the~     way patients feel and can take of themselves, despite otherwise good pain control and~     minimal limitations from the surgery itself.~   "
63463|NCT02226588|"~     The objective of this study is to compare two community-level strategies: either selective,~     early administration of 800 mcg sublingual misoprostol to women for secondary prevention of~     postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of~     delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority~     trial is its potential to inform service delivery programs on clinical outcomes, program~     feasibility, cost, and acceptability of two different community models of PPH care using~     misoprostol.1. The study hypothesizes that a service delivery model that administers~     misoprostol for secondary prevention is non-inferior to a model that administers misoprostol~     for universal prophylaxis.~   "
63464|NCT02226575|"~     The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress~     management program targeting wellbeing in patients with atrial fibrillation and their~     relatives.~   "
63465|NCT02226562|"~     The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate~     mouthwash formulation when used as an adjunct to brushing with a standard fluoride~     dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a~     standard fluoride dentifrice alone. This will be a single centre, eight week, randomised,~     examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff~     Sensitivity Score of the two selected test teeth) study in participants with at least two~     sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants~     will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and~     safety.~   "
63466|NCT02226549|"~     This study is to evaluate the antiviral efficacy, safety, and tolerability of combination~     therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir~     (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1~     hepatitis C virus (HCV) infection and cirrhosis.~   "
63467|NCT02226536|"~     Introduction: the global sugar consumption has increased in the past 50 years and their~     abusive intake is responsible for the insulin resistance and causes the metabolic syndrome -~     obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate~     the effect of scheduled diet without glucose as treatment of labyrinthine disorders~     associated with glucose-insulin index. Study Design: A prospective randomized controlled~     trial. Patients and Methods: A study conducted at the University of São Paulo with 51~     patients divided into two groups: Diet Group (DG) that comprises subjects treated with~     fractionated diet with glucose restriction and control group (CG) where individuals were not~     counseled regarding diet. Patients underwent computerized dynamic posturography - sensory~     organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days~     of the study.~   "
63468|NCT02226523|"~     To improve the sensitivity and specificity of immunoassay, the developing trends are to~     lower the detection threshold and to minimize the cross reaction. A new assay technology~     called immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with~     small volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and~     operational priority in busy emergency departments (ED), early and correct diagnosis is~     important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and~     electrocardiography (ECG) in combination with the medical history and physical examination~     are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good~     diagnosis accuracy and have additional prognostic information are highly needed. The~     combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque~     ruptures or heart failure with different mechanism) may increase clinical sensitivity and~     improve early risk stratification. The present study, a rapid IMR assay with multiple~     biomarkers is proposed and we will examine the performance of this new investigational IMR~     assays, comparison with current commercial assays.~   "
63501|NCT02226094|"~     The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT~     in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of~     the study is to investigate the durability, repeatability, and does response of the same.~   "
63502|NCT02226081|"~     We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam~     can improve the characterization (classification) of breast lesions.~   "
71681|NCT02119104|"~     The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v)~     in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months,~     exclusive.~   "
63469|NCT02226510|"~     Thickening of the heart muscle (left ventricle) known medically as Left Ventricular~     Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of~     cerebrovascular/cardiovascular event.~      LVH is asymptomatic and managed by the use of medication to control blood pressure, however~     LVH may be seen in normotensive patients where factors such as obesity and insulin~     resistance are present.~      Insulin resistance is a condition where although the body produces insulin it is unable to~     utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin~     resistance and cause weight loss, it may therefore improve LVH. This study will investigate~     the ability of metformin to reduce LVH in patients with heart disease, this may be a novel~     way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants~     will be identified throughout NHS Tayside, those eligible will be randomly allocated to~     either metformin or a dummy medication (placebo) and will receive one year of treatment. At~     the beginning of the study, the thickness of the heart muscle will be measured by ultrasound~     scan and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests~     to measure blood vessel function. These tests will be repeated after one year. At the end of~     the study, we will investigate the difference between placebo treatment and metformin~     treatment.~      This study is funded by the British Heart Foundation.~   "
63470|NCT02226497|"~     This randomized pilot clinical trial studies a home telemonitoring device in managing the~     care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are~     discharged from the hospital following chemotherapy. After treatment and hospital discharge,~     patients typically need extensive care to deal with the side effects of chemotherapy, keep~     up with medications, and obtain medical assistance. A home telemonitoring device would allow~     patients to monitor vital signs, symptoms, and use of medications, communicate with~     healthcare providers, and access educational material. A telemonitoring device may allow~     patients to be managed more effectively than standard outpatient care after being discharged~     from the hospital.~   "
63471|NCT02226484|"~     Purpose:~        1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the~          esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and~        2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by~          improvement in the barrier function and acid resistance of the lining of the esophagus~          of patients with a diagnosis of gastroesophageal reflux disease (GERD)~      If interested, participants will be consented and provided a questionnaire to complete as~     part of the study. Participants will undergo endoscopy for routine care and will have up to~     8 esophageal biopsies (small tissue samples) taken for the research study. After endoscopy,~     participants will be contacted to begin a 6 week treatment period with study drug~     (Quercetin, taken twice daily).~      At the end of the 6 week period, participants will be scheduled to have blood drawn and to~     have a follow-up endoscopy with biopsies performed for the research study.~   "
63472|NCT02226471|"~     Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines~     may play important roles in the pathogenesis of obesity, which are a link between obesity~     and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein~     4 (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This~     study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and~     essential hypertension.~   "
63473|NCT02226458|"~     The investigators hypothesize that EPI-743 may provide clinical benefit to children with~     Autism Spectrum Disorder.~   "
63474|NCT02226445|"~     The investigators knowledge of factors associated with treatment drop-out and missed~     appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a~     naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in~     randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates~     are reported in two naturalistic studies of medication adherence.~      Based on proposed hypotheses that past behaviour patterns are more predictive of current~     behaviours of treatment drop-out and missed appointments than are sociodemographic and~     clinical characteristics, the aim of the present study is to examine the associations of 1)~     sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational~     and occupational instability and 5) behaviours during primary/lower secondary school with~     treatment drop-out and number of missed appointments.~      The target group of the study consists of all patients who initiates assessment at the adult~     ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the~     period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic~     from general practitioners and specialised psychiatric authorities. The investigators study~     is designed as an observational, cohort study in which the patients are offered medical and~     non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic~     from which the data are collected.~      Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour,~     educational and occupational instability and behaviours during primary/lower secondary~     school are collected using a semistructured protocol.~      In the investigators study the investigators define treatment drop-out as premature~     termination of ongoing treatment, without any prior clinical or agreed resolution. No~     standardized definition of treatment drop-out is used through out the literature of~     adherence to treatment among patients in the psychiatric care system.~   "
63475|NCT02226432|"~     The objective of the present trial is to demonstrate Magnetic stimulation as an useful~     complementary treatment in order to improve patients' evolution without the need of~     extensive surgical lesion.~   "
63476|NCT02226419|"~     The investigators wish to investigate fat and sugar metabolism during exercise with and~     without L-carnitine supplementation in patients with carnitine transporter deficiency (CTD).~      Patients with CTD have low plasma- and muscle concentrations of carnitine, which is believed~     to lead to an impaired fat oxidation. Presently there is no cure available for these~     patients, but daily intake of L-carnitine has been shown to limit the amount of symptoms.~     Little is known about the metabolism during exercise and the pathophysiological mechanisms~     causing the symptoms.~      Studying the fat and sugar metabolism in CTD patients will contribute to the understanding~     of the role of the carnitine transporter in the development of symptoms in these patients.~     Furthermore, knowledge about the fat and sugar metabolism in these patients can increase the~     understanding of the role of the carnitine transporter in the metabolism healthy persons.~      The investigators have included 8 patients with genetically verified CTD in the study and a~     group of 10 age- and sex-matched controls. Subjects will perform a 1h cycling test,~     exercising at a moderate intensity. By measuring the expiration of carbon dioxide (CO2) and~     consumption of oxygen (O2), the investigators can determine the total fatty acid and~     carbohydrate oxidation during cycling. At the same time the investigators will measure the~     patients' whole body palmitate (fat) and glucose (sugar) oxidation rates using stable~     isotope technique.~      The patient group will repeat the cycling test after 4 days without taking their usual~     L-carnitine treatment. During the treatment break, patients will be admitted to be~     continuously monitored for heart rhythm disturbances, which is a known but rarely occurring~     complication to untreated CTD.~      Since the patients have a defect in their fat metabolism, the investigators expect to find~     that they have a reduced ability to burn fat, which is the major source of energy during low~     intensity exercise. It is therefore likely, that the CTD patients will benefit from~     adjustments in their daily diet, whenever they have to perform physically. By learning about~     the metabolism of different dietary substances, fat and sugar, these studies can help to~     improve the treatment in terms of dietary recommendations for CTD patients. This will have a~     direct impact on the daily life of the patients.~   "
63823|NCT02221895|"~     The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week)~     postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The~     study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher~     rate of breastfeeding 6 months postpartum.~   "
63478|NCT02226393|"~     Traumatic events have potentially debilitating long-lasting effects on the child's normal~     development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy~     has been found to be effective in reducing posttraumatic stress disorder symptoms in adults~     and in adolescents. It has not yet been tested in toddlers.~      The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for~     toddlers with PTSD and their parents. A randomized control trial could examine the efficacy~     of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous~     conditions would help broaden our knowledge about developmentally sensitive treatment tools~     for this age group.~      Our research hypotheses are:~        1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.~        2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers'~          parents.~        3. These results will be preserved in a follow-up of 3-6 months post treatment. Following~          psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50~          participants in each group).~   "
63479|NCT02226380|"~     Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant~     chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a~     series in local advanced gastric cancer patients.~      Patients and methods: The study is a prospective non-randomized study. Patients with~     histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled~     in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2~     lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative~     chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with~     postoperative pathologic staging on patients who underwent radical surgery. Tumor~     down-staging and the grade of pathologic response are included in a statistical correlation~     between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The~     primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,~     R0 resection rate, toxicity and prediction of response.~   "
63480|NCT02226367|"~     The purpose of the study is to evaluate if the drug prazosin:~        -  will decrease alcohol use in active duty members of the military who served in Iraq~          and/or Afghanistan and~        -  determine if presence or absence of posttraumatic stress disorder affects treatment.~   "
63481|NCT02226354|"~     Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a~     rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between~     omega-3 fatty acids found in other plants (such as flax) and those found in fish oils.~      The objectives of this study to collect safety data and to investigate the accumulation of~     long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation~     with Ahiflower oil in healthy adults.~   "
63482|NCT02226341|"~     Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the~     healthy cells and tissues, causing inflammation that can damage organs in the body. About~     50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to~     determine the effectiveness and safety of two dosing arms of ACTHar gel in treating~     proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar~     are safe and effective in treating proliferative LN (Class III and IV).~   "
63483|NCT02226328|"~     Flexible bronchoscopy almost always requires sedation to be successful. In order to increase~     the availability of propofol for sedation, non-anaesthesiologist administered propofol~     sedation has been suggested as an alternative to traditional midazolam/opioid sedation or~     the general anaesthesia provided by anaesthesiologists.~      Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist~     administered sedation with propofol as opposed to non-anaesthesiologist administered~     sedation with midazolam and fentanyl.~      Propofol sedation is as safe as midazolam and fentanyl sedation.~   "
63484|NCT02226315|"~     This study will evaluate the clinical performance of massively parallel sequencing (MPS)~     using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA~     extracted from a maternal blood sample obtained from women pregnant with a multiple~     gestation who were at increased risk for fetal aneuploidy.~   "
63485|NCT02226302|"~     The objective is to develop an organotypic model to assess the effects of obesity on the~     expression and methylation status of estrogen-responsive genes in endometrial cancer.~     Omental fat samples will be removed from participants during surgery and these fat samples~     will be used in laboratory analyses.~   "
63486|NCT02226289|"~     Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor~     (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and~     second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with~     cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.~   "
63487|NCT02226276|"~     This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic~     acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to~     treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor~     receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper~     Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive~     substance. Diagnostic procedures using PET may allow scanners to take pictures of where the~     drug travels in the body and may help doctors identify which patients may benefit from~     treatment with ado-trastuzumab emtansine.~   "
63488|NCT02226263|"~     The purpose of this study is to know the effects of probiotics on the incidence of~     Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.~   "
63489|NCT02226250|"~     Primary objective is to determine absorption profile of a sugar-based beverage on~     inflammatory mechanism by timing of beverage consumption relative to meal intake.~      Secondary objective is to determine absorption profile of a sugar-based beverage on~     oxidative and metabolic mechanism by timing of beverage consumption relative to meal intake.~      The results will be served as an internal reference or negative control group to compare~     with polyphenol containing studies from other studies.~      Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with~     standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size~     of 12 will be recruited into this part of the study.~      This study is a single-arm design utilizing a multiple sampling, and repeated measures~     paradigm to evaluate timing influence of consumption of sugar-based beverage associated~     acute effect on inflammatory markers.~   "
63490|NCT02226237|"~     The prostate cancer is the most common parenchymal neoplasia in men over 45 years old.~     Radical prostatectomy is curative treatment is most used today. Urinary incontinence and~     erectile dysfunction are the main complications of radical prostatectomy. Physical therapy~     has been used as a form of conservative treatment of these complications. However, the role~     of physiotherapy in the treatment of these complications is not well defined in the~     literature. We will do a randomized controlled study with patients undergoing radical~     prostatectomy. After removal of the Foley catheter, patients will be randomized into 3~     groups: control group, group of pelvic floor exercises and anal electrostimulation group.~     These patients will be evaluated preoperatively in an attempt to meet prognostic factors for~     urinary incontinence and erectile dysfunction. They will be followed by 2 years after~     surgery, to assess whether the therapy will alter the course of urinary continence and~     erectile function in these patients.~   "
63491|NCT02226224|"~     In our era of personalized treatment, both the prognosis and the choice of therapy for upper~     GI malignancies depend on the staging before any treatment. Most experts recommend EUS~     (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in~     clinical practice varies in different centers according to the published data. Neither the~     discrepancy between EUS and histological findings nor the variation between centers well~     explained. So the investigators designed this prospective study. In the present study, the~     investigators performed EUS on the resected specimen after surgery before fixation in~     formalin, evaluated the invasion of the GI wall, and marked the deepest location with~     sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy~     between EUS and histologic findings.~   "
63492|NCT02226211|"~     Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice.~     they can be used as primary airway devices or as conduits for endoracheal intubation and~     they become an integral part in the recent guidelines for managing difficult airway.~      Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal~     intubation.~      The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage~     over the competitors but not will studied as a conduit for endoracheal intubation.~      This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the~     air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.~   "
63493|NCT02226198|"~     The purpose of the study is to establish the efficacy, safety and tolerability of~     rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.~   "
63494|NCT02226185|"~     Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,~     anticancer activity of berberine hydrochloride have been explored. The aim of this study is~     to investigate the effect of berberine hydrochloride on the recurrence of colorectal~     adenomas.~   "
63495|NCT02226172|"~     A lead-in cohort of ~20 patients with primary or secondary myelofibrosis previously treated~     with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety~     and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized~     2:1 to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to~     ruxolitinib.~   "
63496|NCT02226159|"~     Cervical radicular pain is a common cause of disability and pain in the upper extremity and~     neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and~     includes relative rest, use of anti-inflammatory and analgesic medication, as well as~     physical therapy and home exercise. For patients who have persistent and significant~     symptoms, interventional pain management and surgical management are considered. Cervical~     epidural injections are the mainstay of the interventional, non-surgical modalities. They~     can be considered to provide short and long-term relief when disc herniation, foraminal~     stenosis or central canal stenosis pathology is identified. We are not aware of any~     published prospective, randomized, controlled, double-blinded studies demonstrating the~     efficacy of cervical transforaminal epidural steroid injections. However, the North American~     Spine Society (NASS) Review and Recommendation Statement states that based on the literature~     and expert opinion, a minimum of one or two cervical epidural steroid injections would be~     very appropriate in the treatment of a specific episode of cervical radicular pain.~      The purpose of this study is to determine the effectiveness of cervical transforaminal~     epidural steroid injections in decreasing the need for an operation in patients with~     cervical radicular pain, otherwise considered to be operative candidates.~   "
63497|NCT02226146|"~     This is an open-label, proof-of-concept, single group study in adult patients with newly~     diagnosed, moderate to extensive BP.~      The study will consist of three periods: a screening period of up to 2 weeks, an open-label~     treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14~     and 28, and a safety and efficacy follow-up period of approximately 13 weeks.~      Patients will receive concomitant oral steroids during the treatment and follow-up period.~   "
63498|NCT02226133|"~     Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique~     is safe and effective.~   "
63499|NCT02226120|"~     The purpose of this study is to collect safety and tolerability data on LCZ696 in eligible~     PARADIGM-HF patients receiving open-label investigational drug.~   "
63500|NCT02226107|"~     Disparities among racial and ethnic minorities remain prevalent despite advances in medical~     science that make thes early detection and prevention of colorectal cancer a possibility for~     all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented~     through screening. Unfortunately, among Latinos, colorectal cancer is the second leading~     cause of cancer death. This rate is influenced by the fact that Latinos have the lowest~     rates of colorectal cancer screening compared to other US racial groups. Moreover, Latinos~     are more likely than whites to be diagnosed with advanced-stage colorectal cancer, when~     treatment options are more limited. Lay health worker interventions for breast and cervical~     cancer education and screening have demonstrated success in increasing both knowledge and~     screening rates among racial and ethnic minorities. Additionally, our research has also~     shown success in training African Americans as peer navigators to increase colorectal cancer~     screening. Few lay health interventions, however, have been designed specifically for~     colorectal cancer screening among Latinos. Thus, the purpose of this study is to expand peer~     navigation for colorectal cancer screening to Latinos and increase their participation in~     screening by training Latinos, who have had a colonoscopy, to help navigate other Latinos~     through the colonoscopy screening procedure.~      This study will focus on expanding the work of our research group by training Latino peers,~     who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy~     screening completion to navigate Latino patients for screening. First, a training manual~     will be developed which will be culturally specific to Latinos. Feedback and input from~     community members will guide the development of the manual and training program. Second, the~     training program will be carried out with six bilingual Latino peers, who will be taught to~     master the core skills of patient navigation for screening colonoscopy. Finally, we will~     gather preliminary information about the trained peers' ability to successfully navigate~     patients for colonoscopy screening. If successful, this training program has the potential~     to increase colonoscopy screening rates of Latinos and will be critical to the development~     of future large-scale in interventions aimed at reducing advanced stage diagnosis of~     colorectal cancer and ultimately colorectal cancer deaths among Latinos.~   "
63504|NCT02226055|"~     1. We hypothesise that CKDu patients will have increased arterial stiffness and thus~          increased all-cause and cardiovascular mortality. The first objective of this study is~          to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura,~          and measure their arterial stiffness using the TensioMed® Arteriograph™ (details~          below). We will recruit an age, sex and blood pressure matched control group of healthy~          Sri Lankans (consenting visitors with patients both to clinic and as inpatients), and~          if possible, a second control group, similarly age, sex and blood pressure matched, who~          have CKD of known causes and attend general renal clinic in Anuradhapura.~        2. We hypothesise that detailed renal analysis will give insight into the aetiology of~          CKDu in the North Central Province of Sri Lanka. The second objective of the study is~          to recruit up to 250 CKDu patients and to characterize their disease profile using~          analysis serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.~   "
63505|NCT02226042|"~     This research will investigate the neuropsychological mechanisms underlying the eight-week~     Mindfulness-based Cognitive Therapy (MBCT) programme.~      Participants in remission from depression will be seen pre- and post-MBCT to assess the~     underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess~     the relationship of these neuropsychological changes with relapse risk.~      The research will focus primarily on changes in self-compassion, rumination, attention and~     structural brain changes, with secondary focus on other mechanisms of emotional processing~     and memory.~   "
63506|NCT02226029|"~     Quantitative MR methods will be validated for the non-invasive imaging of GI processing of~     lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized~     single blind two-armed crossover trial with two isovolumetric and isocaloric lipid emulsions~     of different microstructural properties. Hypotheses of this sudy are that~        1. the fat fraction of lipid emulsions in the GI tract can be monitored by quantitative MR~          methods and that 13C-sodium octanoate and~        2. 13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to~          their opposing binding affinity to water and fat.~   "
63507|NCT02226016|"~     The purpose of this study is to assess a new technique of measurement for the levator~     muscle.~      this measurement may be applied during a clinical evaluation of eyelid malposition.~      our purpose is to quantify the levator muscle strength and to corelate it to standard~     levator muscle strength assessment techniques routinley used in the oculoplastic clinic.~   "
63508|NCT02226003|"~     This is a study to evaluate the efficacy and safety of the ertugliflozin~     (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with~     Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The~     primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in~     lowering of hemoglobin A1C (HbA1C) than placebo.~   "
63509|NCT02225990|"~     The purpose of this research study is to implement into clinical practice, the comprehensive~     QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility,~     and fitness training. Feasibility will be tested in the clinical environment by providing~     the intervention, measuring patient outcomes, and identifying the obstacles to insurance~     payment for the QualPro intervention. By productively addressing issues of implementation,~     the hypotheses of this study include proven feasibility in the clinical environment and~     clinically significant gains for stroke patients in the areas of strength, balance, gait~     coordination, endurance, physical function, and increased life role participation.~   "
63510|NCT02225977|"~     In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune~     homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype~     in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this~     study we will determine the change in ratio of M2 (type II, alternatively activated) versus~     M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that~     have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess~     changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301~     by monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine~     phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1),~     which is critical for the activation of M1 myeloid cells. We will assess correlates with~     changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya~     on myeloid lineage cells.~   "
63511|NCT02225964|"~     This study is to find out the imaging marker and the changing laws of the marker during the~     course of the disease. The final purpose is to provide scientific evidence for new~     prevention, diagnosis and treatment of Alzheimer's disease.~   "
63512|NCT02225951|"~     This study is initiated to investigate the effect of a nutritional product on the 3-hr~     postprandial glucose response compared to a control standard breakfast at baseline and after~     4 weeks of intervention.~   "
63513|NCT02225938|"~     Increasingly patients with critical illness requiring life support in an intensive care unit~     are surviving their hospital admission. Currently the investigators do not know what effect~     the ICU admission, and the life support, has on their long-term quality of life and whether~     they can return to their pre-illness level of function following ICU.~      The investigators aim to test telephone follow-up of ICU survivors in assessing function and~     quality of life six months after ICU admission. Additionally, the investigators will~     identify if there are factors that lead to poor recovery. The investigators hope this can~     influence and change current ICU practice to improve recovery and long-term outcomes for~     patients.~      The investigators aim to select a total of 300 patients from ICU, 75 patients from each of~     the four ICUs. If they survive to hospital discharge, patients and their relatives will~     receive a telephone questionnaire at 6 months after the ICU admission that aims to assess~     their long-term outcomes, including physical, cognitive and emotional function, quality of~     life, and whether they have been able to return to work following ICU.~   "
63514|NCT02225925|"~     The purpose of this study is to assess the performance of a system of intraoperative dynamic~     dosimetry during prostate seed implantation (brachytherapy) including its new elements, to~     evaluate and refine technical methods of using the system, as well as confirm its~     performance and accuracy.~   "
63515|NCT02225912|"~     The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a~     day will prevent upper respiratory infections in otherwise healthy adults working in child~     day care centers.~   "
63516|NCT02225899|"~     With better medical care, patients with cystic fibrosis (CF), a life-threatening disease,~     are enjoying longer lives. As the CF life expectancy increases, conditions such as~     CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in~     maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate~     nutrition-related factors, such as vitamin D status, on oxidative stress and fat oxidation~     which may influence long-term survival in CF and CFRD. Based on preliminary clinical and~     metabolomics research findings, the working hypotheses of this project are: 1) oxidative~     stress in CF contributes to impaired fat oxidation, and 2) vitamin D supplementation~     normalizes oxidative stress and, subsequently, fat oxidation. This study will combine state~     of the art methods with traditional clinical methods to assess fat oxidation, oxidative~     stress, and nutritional status in adults with cystic fibrosis. Research methods include~     blood draws for plasma markers of oxidative stress and metabolomics (the measurement of~     thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess~     energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and~     regional body fat and muscle), and indirect calorimetry (to assess resting energy~     expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function,~     CF genotype, and diabetes status will be obtained from the electronic medical record and the~     CF Registry. This study consists of two sub-studies. The first is a cross-sectional study in~     66 clinically-stable adults with CF and 44 healthy control participants. Testing in~     clinically-stable adults will occur in the Emory University Hospital (EUH) Clinical Research~     Network (CRN) outpatient unit (blood draws, indirect calorimetry, DEXA) and in the Emory~     University Biomedical Imaging Technology Center (BITC) for MRI imaging. The second study~     will be an ancillary longitudinal study to the ongoing, double-blind, placebo-controlled,~     randomized high-dose vitamin D trial (DISC Study, IRB00052829, PI: Tangpricha) in patients~     with CF who are hospitalized for pulmonary exacerbation. Blood draws and indirect~     calorimetry will be performed in patients within 72 hrs of hospital admission (before~     vitamin D dosing), and during 3 and 6 month outpatient follow-up visits. The data generated~     from this study will be used to inform future nutrition intervention studies in adults with~     CF and CFRD.~   "
63517|NCT02225886|"~     The administration of ascorbic acid seemed to increase the iron available for~     erythropoiesis, thus improving the anemia response to the treatment.~      The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid~     administration in hemodialysed patients with iron overload.~   "
63518|NCT02225873|"~     This study will verify whether the cranio-cervical flexion coordination (motor control) and~     muscle strength training protocol is more effective in improving muscle than the~     proprioception and muscle strength protocol in patients with chronic neck pain.~      Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol~     will improve muscle function more than the proprioception and muscle strength protocol in~     patients with chronic cervical pain.~      Objective: To find out if applying the strength therapeutic exercise protocol and the~     craniocervical flexion coordination (motor control) training is more effective than the~     strength and articular repositioning protocol when carrying out the craniocervical flexion~     test in patients with chronic cervical pain.~   "
63519|NCT02225860|"~     The purpose of this study is to learn if dietary habits can affect vasopressin secretion in~     patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth~     of kidney cysts and accelerates disease progression. Understanding how to control secretion~     of this hormone based on dietary habits may help to develop treatments to control this~     disease. The study will include about 60 patients from Tufts Medical Center. The study will~     last for 2 weeks. Blood and urine tests will be done 3 times during the study period.~     Subjects will be randomly assigned (by chance like flipping a coin), to one of two study~     groups. Group 1 will be given instructions to adjust their diet. This will include adjusting~     the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or~     water. The project has tremendous public health relevance, given the large numbers of people~     affected by autosomal dominant polycystic kidney disease and the substantial impact of the~     disease on morbidity, mortality, hospitalizations,dialysis or transplant, and societal costs~     of caring for those patients.~   "
63520|NCT02225847|"~     The objective of the research is to test the hypothesis that participating in group-based~     gardening activities alters brain network activation and function, and that such change~     occurring in the brain forms the neurobiological basis for much of the nonphysical activity~     portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of~     the effects of the gardening activities on the experimental population will take two~     approaches, the first being the use of functional Magnetic Resonance Imaging (fMRI) to~     assess the regions of the brain that may become activated as a consequence of experiencing~     the cumulative gardening activities and associated stimuli. The allied approach will employ~     widely used and well-established self-reported assessment instruments that will capture~     information about the health and well-being that will then provide a psychometrically-based~     before and after physical and health summary of the participants in the control group and~     those engaged in the gardening activities.~   "
63521|NCT02225834|"~     Recent clinical trials and meta-analyses of b-hydroxy-bmethylglutaryl coenzyme A (HMG-CoA)~     reductase inhibitors (statins) have demonstrated a significant reduction in ischemic stroke~     in patients with a history of coronary artery disease, both with and without elevations of~     serum cholesterol. Recent data suggest that statins have other beneficial properties in~     addition to the retardation of atherosclerosis. Asahi et al demonstred that Statins~     increased eNOS and tPA mRNA levels but did not change mRNA levels of PAI-1 and that In eNOS~     knockout mice, atorvastatin reduced the volume of ischemic tissue and improved neurologic~     outcomes after arterial occlusion by blood clot emboli. In addition to their lipid-lowering~     effects, it has been speculated that statins may also have beneficial effects on cerebral~     circulation and brain parenchyma during ischaemic stroke and reperfusion. Aslanyan et al~     reported that statin use was associated with reduced mortality at 1 month during the~     follow-up.~      In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of~     atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events,~     despite a small increase in the incidence of hemorrhagic stroke period .~      Recently the investigators group reported that lacunar strokes compared to nonlacunar ones~     exhibited significantly lower plasma levels of TNF-α and IL1-β, P-selectin and ICAM-1 24-72~     h and 7-10 days after stroke onset (4). At extracranial arterial territories, inflammation~     plays a crucial role mediating all the stages of the atherosclerosis process . Similarly,~     thrombosis and defective fibrinolysis may also contribute to the progression of~     atherosclerotic lesions . Interestingly, both mechanisms might have a relevant role in the~     pathogenesis of intracranial large artery atherosclerosis and ischemic stroke Moreover our~     group showed that Patients with cardioembolic and atherothrombotic stroke subtypes showed~     significantly higher median plasma levels of TNF-α, IL-6, IL-1β whereas the lacunar subtype~     showed significantly lower median plasma levels of TNF-α, IL-6 and IL-1β and that~     immunoinflammatory marker plasma levels are significantly related to ischemic lesion volume.~      A meta-analysis showed that statins may possess antithrombotic property because these drugs~     were reported to reduce periprocedural infarction in patients undergoing percutaneous~     coronary intervention .~      This clinical benefit was detected after median, 0.5 days of treatment with statins~     (indicating that statins could potentially exert an antithrombotic effect even earlier than~     supposed from pharmacological studies.~      Violi et al recently showed the first evidence that atorvastatin acutely and simultaneously~     decreases oxidative stress and platelet activation by directly inhibiting platelet Nox2 and~     ultimately platelet isoprostanes and thromboxane A2 so providinf a rationale for the use of~     statins to prevent or modulate coronary thrombosis.~      Whereas recent data suggest that inflammatory reactions are involved in the pathogenesis and~     progression of cerebral ischaemia , no study has evaluated effects of atorvastatin 80 mg/day~     after a recent stroke on stroke outcome and on immunoinflammatory markers so to evaluate~     acute antithrombotic and anti-inflammatory effects of atorvastatin also in acute~     cerebrovascular event setting.~      On this basis the primary objective of the study was to evaluate the separate effects of~     atorvastatin in vivo on immunoinflammatory markers and on stroke prognosis in patients with~     recent acute ischemic stroke classified as atherothrombotic.~   "
63522|NCT02225821|"~     In the Netherlands about 18,000 surgical procedures with implant removal are annually~     performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg~     region. For clean surgical procedures, the rate of postoperative wound infections (POWIs)~     should be less than 5%. However, rates of 10-12% following implant removal, specifically~     after foot, ankle and lower leg fractures are reported. Currently, surgeons decide~     individually if antibiotics prophylaxis is given, since no guideline exists. This leads to~     undesirable practice variation.~      Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in~     patients scheduled for implant removal following a foot, ankle or lower leg fracture, to~     assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome~     is a POWI within 30 days after implant removal. Secondary outcomes are quality of life,~     functional outcome at 30 days and 6 months after implant removal and costs.~      With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in~     clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%,~     2-sided alpha=5%, including 15% lost to follow up).~      If the assumption of the investigators, that prophylactic antibiotics prior to implant~     removal reduces the infectious complication rate, is confirmed by this RCT, this will offer~     a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of~     care. This will reduce the incidence of POWIs and consequently will lead to less physical~     and social disabilities and health care use. In addition, it will decrease the rate of use~     of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion~     or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings~     in the Netherlands of €3.5 million per year.~   "
63529|NCT02225730|"~     Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain.~     Unblocking the blood vessel with a blood clot removal device restores blood flow and if done~     quickly may prevent the disability that can be caused by a stroke.~      However, not all stroke patients benefit from having their blood vessel unblocked.~      The aim of this study is to determine if special brain imaging, called MRI, can be used to~     identify which stroke patients are most likely to benefit from attempts to unblock their~     blood vessel with a special blood clot removal device. In particular, we will assess in this~     trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can~     demonstrate the presence of collateral blood flow (compared with a gold standard of the~     angiogram) and whether it is useful to predict who will benefit from treatment.~   "
63523|NCT02225808|"~     This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for~     anxiety in children with high-functioning autism spectrum disorder (ASD). In addition to the~     core symptoms, approximately forty percent of children with ASD exhibit clinically~     significant levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment~     for anxiety in children with high-functioning ASD, but the neural mechanisms of this~     treatment have not been studied. CBT teaches emotion regulation skills such as cognitive~     reappraisal, followed by behavioral exposure to anxiety-provoking situations. The~     investigators propose to investigate the neural mechanisms of CBT for anxiety by evaluating~     fMRI indices of socioemotional functioning before and after treatment in children, ages 8 to~     14, with high-functioning ASD. Dysfunction of the amygdala and its connectivity with~     prefrontal cortex has been implicated in co-occurring ASD and anxiety. In the investigators~     research, compared to typically developing controls, children with ASD have shown lower~     activation in several regions of prefrontal cortex and a lack of down-regulation in the~     amygdala during a task of emotion regulation. Based on these observations, the investigators~     propose that a positive response to CBT for anxiety in children with ASD will be associated~     with increased activation of several regions in the prefrontal cortex as well as increased~     functional connectivity between prefrontal regions the amygdala during the task of emotion~     regulation. The primary aim of this pilot study is to examine the effects of CBT on the~     neural basis of anxiety in ASD by collecting fMRI data during emotion regulation, face~     perception, and rest before and after treatment. The investigators hypothesize that CBT will~     increase prefrontal activity, decrease amygdala reactivity, and enhance amygdala-prefrontal~     functional connectivity during emotion regulation. The investigators also hypothesize that~     CBT will decrease amygdala reactivity during perception of emotional faces. Additional~     analyses will be conducted to explore change in resting-state functional connectivity before~     and after CBT for anxiety in children with ASD.~   "
63524|NCT02225795|"~     This is a study for people with Crohn's Disease (CD) that are not responsive to standard~     treatment. CD is a chronic disease with an auto-immune component that goes away and relapses~     over the years and causes lifelong impairment of health and quality of life. Regardless of~     the therapy used some patients remain seriously ill with active disease after multiple~     therapeutic options have been exhausted. There is currently no drug that will cure CD. Drug~     treatment is focused on controlling symptoms. Another treatment is to perform surgery but~     again this does not lead to cure and is often linked to infection, short gut syndrome~     problems and psycho-social and cosmetic issues. Therefore, a treatment that does not involve~     surgery or long-term drug treatment may be beneficial especially to young adults.~      Hematopoietic stem cell transplantation (HSCT) has been of value in other auto-immune~     diseases and it is possible that it could be of value in CD. This is a pilot study to~     determine if HSCT is safe and effective for children and young adults with severe CD. For~     this study the stem cells will come from the patient. This is called an autologous~     transplant. The patient will undergo collection and storage of his/her peripheral blood stem~     cells (PBSC). The patient will be given drugs to move (or mobilize) the stem cells from~     his/her bone marrow into his/her blood where they will be collected on a machine called~     apheresis (similar to dialysis.) The cells will be stored and given back to the patient~     about 1 month after collection.~   "
63525|NCT02225782|"~     Hemodialysis is a procedure that kidney physicians perform when the kidneys fail and can no~     longer clean the blood and remove extra fluid and toxins from the body. Hemodialysis~     therefore requires access to reach the blood through either a surgically created permanent~     fistula or graft or through the insertion of a temporary catheter in one of the large body~     veins. While the use of fistulas or grafts is preferred because they are permanent, there~     may be conditions that prevent patients from having them and a hemodialysis catheter may be~     used instead. The problem with the use of catheters however is that they can become blocked~     due to the formation of blood clots. Kidney physicians try to resolve occlusion of~     hemodialysis catheters by injecting a medication called Alteplase which breaks the clot at~     the catheter site. There is no consensus in the medical community as to how much of the~     medication should be injected at the occluded catheter site. While some kidney physicians~     and studies recommend the use of 1.0 mg of the medication at each occlusion site, others~     recommend that 2.0 mg of the medication should be used. Thus, the purpose of this randomized~     clinical trial is to compare the effectiveness of 1.0mg versus 2.0mg dose of alteplase in~     resolving blood clots in hemodialysis catheters.~      The investigators will recruit patients for the study from a regional hemodialysis unit that~     is located in southwestern Ontario. Patients who agree to participate in this research and~     experiences occlusion of their hemodialysis catheters will be divided into two groups;~     making sure that this division is completely by chance. The first group will receive 1.0mg~     alteplase, while the second will receive 2.0mg Alteplase. The investigators will collect~     information on both groups and will run statistical analysis of these information to compare~     the results of clot resolution between the groups.~   "
63526|NCT02225769|"~     Health professionals in developing countries have limited ability to identify children at~     risk of dying and those in need of antibiotics. The main reasons are limited clinical skills~     and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to~     practice guidelines. Child mortality is therefore higher than it should be. Etiological~     diagnostic tests (detecting microorganisms) may not always help since the distinction~     between infection and disease and between mild or severe disease is not straightforward.~     Overprescription of antibiotics is therefore widespread and leads to the development of drug~     resistance. To address these challenges, decision charts for the management of febrile~     illness will be developed and include i) few clinical parameters simple to assess, and ii)~     POCTs results based on specific host markers that can discriminate between mild and severe~     disease, pneumonia and upper respiratory tract infections, and unspecific fevers of~     bacterial and of viral origin. This algorithm combining clinical and bedside laboratory~     tests will be built on an electronic support (android tablet). The first objective of the~     study is to assess the safety of new electronic decision trees that integrate simple~     clinical assessment and POCTs results (oxygen saturation and a combination of specific~     biomarkers of inflammation) as a triage tool to decide on admitting febrile children; the~     second objective is to assess the usefulness and safety of new electronic decision trees~     that integrate simple clinical assessment and POCT results (a combination of specific~     biomarkers of inflammation) as decision-making tool to prescribe antibiotics to non-severe~     febrile children. The development of such a tool will decrease mortality due to delayed~     admission, At the same time, it will decrease irrational use of antibiotics, and hence drug~     pressure and emergence of drug resistance, which represents one of the most important public~     health threat our world is facing today. This project has the potential of huge~     applicability since it is specifically designed for end-users with limited medical skills~     and low resources, as it is the case in most areas of developing countries.~   "
63527|NCT02225756|"~     Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood~     to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high~     for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small~     aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A~     drug that would stop growth of small aneurysms would obviate aortic surgery, the current~     treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the~     possibility to stop growth of small aortic aneurysms in the abdomen with a drug,~     cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a~     placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be~     evaluated by measuring the diameter of the aneurysm during 2 years after treatment~     cessation. Drug safety analysis will evaluate the impact of the drug on renal function,~     blood pressure, and other parameters. In case of adverse event during the drug~     administration phase, dose of the drug or of the placebo will be decreased or administration~     stopped.~   "
63528|NCT02225743|"~     Total joint patients have poor outcomes with infection since they are having permanent~     hardware implanted. Infection prevention in this group is therefore critical and a major~     source of discussion in both the orthopedic and anesthesia literature.~      Hypothermia has been shown to increase the risk of infection and blood loss. However,~     studies have not examined when in the operation or how fast patients temperatures drop. This~     study will observe how patients' temperatures change during total joint arthroplasty. By~     identifying when body temperature changes occur, prevention strategies may be developed and~     implemented.~   "
63824|NCT02221882|"~     The main purpose of this study is to evaluate the safety of a study drug known as LY3164530~     in participants with cancer that is advanced and/or has spread to another part(s) of the~     body.~   "
63530|NCT02225717|"~     The investigators project aims to identify, in pregnant women, discriminating molecules to~     allow an early detection of women who will spontaneously deliver prematurely, suitable in~     routine clinical practice.~      Human parturition is tightly correlated with hormonal changes at the maternal-fetal~     interface during pregnancy, that may control cell interactions and fetal membranes (the~     water bag) remodelling. Precocious remodelling may lead to a premature onset of labor,~     associated or not with premature rupture of membrane whether the cause is infectious or not.~      In this regard, remodelled fetal membranes overlying the cervix may discharge signals that~     could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of~     delivery. Such information on delivery timing may be of great importance for an adequate~     prediction that would change drastically the management of threatening preterm delivery.~   "
63531|NCT02225704|"~     This study aims to determine the safety and tolerability of Radium-223 when administered in~     combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.~   "
63532|NCT02225691|"~     This study aims is to evaluate the effect of introducing paired testing on actual testing~     frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled~     diabetes patients in China.~   "
63533|NCT02225678|"~     Can a clinical test be developed that could help manage asthma symptoms?~   "
63534|NCT02225665|"~     The purpose of this study is to evaluate the safety and tolerability of repeat doses of~     T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.~      CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger~     nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from~     HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc~     finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in~     the study.~   "
63535|NCT02225652|"~     TITLE: A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and~     Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly~     Paclitaxel in Women with Primary Breast Cancer.~      PROTOCOL CODE: IRST 174.05~      PHASE: II~      STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial~      DESCRIPTION OF STUDY TREATMENT:~      FEC + filgrastim x 3 cycles q 14-21 days~      Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60~     mg/m2 IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).~      From day 7 until hematological recovery = Filgrastim 300 microg s.c.~      After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly~     for 8 cycles, at day 1).~      NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27~     patients to the second stage if at least 7 patients complete the planned treatment.~      OBJECTIVES~      Primary objective: this trial is designed to assess feasibility of the proposed regimen with~     regard to toxicity and deliverability. Tolerability is defined as absence of any grade 3 or~     higher nonhematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might~     be a consequence of the administration of filgrastim). Deliverability is measured as the~     percentage of patients who complete the planned treatment.~      Secondary objectives:~        -  Relapse-free survival: measured from enrollment to the first date between date of~          documented relapse (or death) or date of last tumor assessment (if no documented~          relapse), or the date of last tumor assessment before the start of any further~          antitumor therapy not planned in the protocol.~        -  Overall survival: measured from enrollment to the date of death of any cause or last~          follow-up.~      CORRELATIVE/SPECIAL STUDIES: to evaluate retrospectively potential biomarkers of activity~     and toxicity of this regimen, blood and plasma samples until 15 mL each one will be~     collected at study entry, before first docetaxel administration and 3-4 weeks after last~     docetaxel administration. Moreover, a paraffin block or specimens of the primary tumor will~     be collected for biological studies.~      STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed~     regimen with regard to toxicity and deliverability.~      Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity~     (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the~     administration of filgrastim).~      A Simon two-stage design has been used with a 60% tolerability rate considered not promising~     and an 80% tolerability rate as promising, and probability of type I and type II errors has~     been set to be 0.10.~      In the first stage, 11 patients have been planned, with an additional 27 patients to the~     second stage if at least 7 patients complete the planned treatment. The regimen would be~     considered tolerable and worthy of further study if at the end of the trial 27 out 38~     patients complete the planned treatment.~   "
63536|NCT02225639|"~     The primary objective of this study is to assess the time of onset and time course of~     efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a~     simulated adult workplace environment (AWE) setting, as measured by the PERMP (an~     individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours~     post-dose.~   "
63537|NCT02225626|"~     Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male~     subjects as well as to investigate pharmacokinetics, safety and tolerability~   "
63538|NCT02225613|"~     Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns~     young sportsmen. Consequences are limitation in physical and sporting activities and at~     work.~      Main objective: to compare water and traditional rehabilitation after cruciate ligament~     injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities~     development.~   "
63539|NCT02225600|"~     The study will examine behavioral patterns and underlying neural correlates which~     distinguish patients with borderline personality disorder (BPD) from healthy subjects as~     they participate in a two-person trust game and will determine whether administration of~     intranasal oxytocin (OT) will normalize trust game performance and concomitant neural~     processing in the BPD group.~   "
63540|NCT02225587|"~     The purpose of this study is to evaluate the safety and immunogenicity of sequential~     administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and~     older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to~     pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as~     measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and~     Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and~     placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as~     measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by~     Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.~   "
63541|NCT02225574|"~     The goal of this clinical research study is to find the highest tolerated dose of the~     combination of nilotinib and MEK-162 that can be given to patients with CML or acute~     leukemia. Researchers also want to learn if the drug combination can help to control the~     disease. The safety of the drug combination will also be studied.~   "
63561|NCT02225314|"~     Computer-Based Cognitive Training for Individuals with Parkinson's Disease is a 3-arm~     randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control~     (AC) training program to evaluate the feasibility of empirically supported computer-based~     cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD)~     with Mild Cognitive Impairment (MCI). This pilot study aims to address the need for~     increased interventions to target non-motor symptoms associated with PD.~   "
63825|NCT02221869|"~     The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics~     subjects with narcolepsy that includes cataplexy.~   "
63542|NCT02225561|"~     Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in~     France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic~     resuscitation survival after cardiac arrest remains low (1-8%) and has not changed~     significantly over the past five decades.It has recently been shown that the combination of~     different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with~     automated compression / decompression and an impedance threshold device, can increase the~     rate of return of spontaneous circulation and short and long term survival after cardiac~     arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium~     nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a~     mechanical component: cardiopulmonary resuscitation with automated mechanical external chest~     compression and an impedance threshold deviceb) a pharmacological component: sodium~     nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and~     improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of~     spontaneous circulation rate during cardiac arrest.~   "
63543|NCT02225548|"~     The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®)~     results in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's~     disease (PD) and moderate ED. Male PD patients who have an incomplete response to tadalafil~     alone will be given both medications to see if the addition of selegiline improves ED~     symptoms more than tadalafil alone. It is common practice for a medical doctor to prescribe~     these two drugs to a patient like you. However, there have been no studies conducted to~     examine the effects of these medications when taken together.~      Selegiline is normally prescribed for PD patients that are taking carbidopa/levodopa who are~     not receiving complete benefit from carbidopa/levodopa.~      Tadalafil is normally prescribed to men who have erectile dysfunction and/or benign~     prostatic hyperplasia (BPH).~   "
63544|NCT02225535|"~     The purpose of this project is to compare usual care for chronic low back disorders in a~     rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy~     (PT) into a rural health care team:~        1. in-person PT assessment, where the PT travels from an urban center~        2. interprofessional Telehealth assessment where the local NP is joined by a PT via~          Telehealth.~      The project will evaluate health, systems and process outcomes, comparative effectiveness~     and costs of the three methods of assessment. The hypothesis is that an interprofessional~     Telehealth assessment with be as effective as an in-person PT assessment, but more effective~     than usual care.~   "
63545|NCT02225522|"~     The purpose of this study is to compare the effectiveness of rapid next generation~     sequencing (NGS, such as whole genome sequencing1) with current practice to provide~     diagnostic or prognostic information or treatment guidance in acutely ill neonates and~     infants, particularly with respect to clinical care, cost and outcomes.~   "
63546|NCT02225509|"~     1. Principal objective:~           The primary objective of this study is to validate the diagnostic performance of a Dx15~          molecular test based on molecular transcriptomic signatures previously identified in~          distincts cohorts of samples to determine the malignant or benign profile of a thyroid~          nodule with indeterminate cytological analysis. The target population includes~          categories III [Follicular lesion of undetermined significance or Atypia of~          undetermined significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for~          follicular neoplasm (FN/SFN)] of the Bethesda classification.~           The expected target performance of the Dx15 molecular test in this target population is~          95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75%~          for sensitivity.~        2. Secondary objectives:~             -  To assess the performance of the Dx15 test in samples collected during the study~               by fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda~               classification categories (categories III, IV and V: suspected malignancy)~             -  To assess the performance of the TI-RADS ultrasonography score for diagnosing~               thyroid cancer in patients presenting with a thyroid nodule and having available~               cytological analysis results.~             -  To check the potential of performance of the molecular signature as well as of its~               combination with other tests by applying it in a blind manner to samples collected~               from patients presenting with thyroid nodules and whose aspiration biopsy result~               is benign (Bethesda category II), malignant (Bethesda category VI) or~               non-diagnostic (Bethesda category I)~             -  To assess the performance of mutation tests (isolated mutations, chromosomal~               rearrangements) for diagnosing thyroid cancer in patients presenting with a~               thyroid nodule and with available cytological results.~             -  To estimate the performance of the combination of the Dx15 test result and other~               diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose~               thyroid cancer in patients presenting with a thyroid nodule and having an~               indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of~               Dx15 diagnostic test results with other study parameters will also be considered~               in order to establish the option of an algorithmic approach for the diagnosis of~               thyroid cancer.~             -  To compare the results of cytological and histological analyses obtained in the~               centres and by centralised reading and assessment of the impact of its results on~               the other study analyses and parameters.~             -  Additional analyses deemed relevant on the basis of various parameters and data~               collected during the study.~        3. Objective of exploratory research:~             -  The use of all or part of the FNA samples for the purpose of research as part of~               thyroid cancers, especially with the objective of optimising or identifying~               additional molecular signatures.~   "
63547|NCT02225496|"~     Standard-of-care treatment options for oropharyngeal cancer often result in long-term side~     effects that interfere with normal quality of life. A minimally-invasive transoral robotic~     surgery (TORS) approach has been developed to operate on the disease site while affecting~     the surrounding tissue as little as possible. Researchers think that this approach may help~     to control the disease and avoid such long-term side effects.~      The goal of this clinical research study is to learn if minimally-invasive transoral robotic~     surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means~     through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical~     System.~      Researchers also want to learn if this surgery affects participants' ability to speak and~     swallow.~   "
63548|NCT02225483|"~     The is study will examine whether variation in clinical bleeding frequency and severity~     among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations~     in laboratory measurements of platelet activity.~   "
63549|NCT02225470|"~     This study is designed as an open-label randomized parallel two-arm multicenter efficacy,~     pharmacokinetics and safety study of intravenously administered eribulin versus~     intravenously administered vinorelbine in Chinese population. Eligible female subjects will~     have measurable disease according to RECIST 1.1 with the modification that chest x-ray~     cannot be used for assessment of disease.~   "
63550|NCT02225457|"~     Obesity results from complex interactions between genetic and environmental factors, and are~     strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity~     is defined as an excessive fat accumulation that presents a risk to health, a risk that is~     highly dependent upon the type of adipose tissue accumulation, whether visceral or~     sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory~     cells accumulation. Because of the well known sexual difference in fat accretion, this~     obesity-associated risk may also be very different for men and for women. In addition,~     recent data indicate that various factors such as the intestinal microbiota, but also the~     dietary intake of protective nutrients might be important determinants of the metabolic~     complications of obesity.~      Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue~     accumulation during a period of controlled caloric over-nutrition, both in men and in women;~     2) evaluate the potential protective effects of a supplementation with polyphenols on~     insulin resistance and other metabolic adaptations.~   "
63551|NCT02225444|"~     OsteoAMP is an allograft (transplantation of part of one person to another person) derived~     growth factor rich bone graft for use in spinal fusion. The study is designed to obtain a~     higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner~     FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center~     study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with~     degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild~     degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo~     instrumented, posterolateral spinal fusion surgery as part of their medical treatment and~     comply with the study eligibility criteria will be given the opportunity to consent and be~     entered into the study.~   "
63552|NCT02225431|"~     The aim of this study was to evaluate, in patients with lower fluid status defined by~     bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are~     associated with different volume expansion and differing risks for CI-AKI in patients~     undergoing coronary angiographic procedures.~   "
63553|NCT02225418|"~     The TQL block may prove a valuable method for treating postoperative pain following scopic~     removal of the gall bladder.~      The trial will compare active TQL block versus placebo TQL block after said operation.~      The hypothesis is that active TQL block significantly will reduce postoperative pain~     following scopic removal of the gall bladder compared with placebo TQL block.~   "
63554|NCT02225405|"~     The goal of this clinical research study is to learn if it is safe to give nintedanib in~     combination with cisplatin and docetaxel before surgery to patients with NSCLC. Researchers~     also want to learn if the drug combination can help to control NSCLC before surgery.~   "
63555|NCT02225392|"~     Approximately 5% of asthma patients suffer from severe asthma that is characterized by~     frequent asthma exacerbations resulting in significant morbidity and excessive utilisation~     of health care resources. Therefore, there is a strong need for improved therapeutic~     strategies for these patients. Insight in the pathogenesis and molecular pathways active in~     severe asthma is crucial to reach this goal.~      Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma~     that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.~      Hypothesis:~      BT-induced clinical improvement in severe asthma is a consequence of reduction in airway~     smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural~     innervation and/or vascular integrity resulting in altered airway remodelling. BT target~     identification and severe asthma phenotyping are critical for improved patient selection for~     BT and fundamental to discover novel, specific signalling pathways active in severe asthma.~   "
63556|NCT02225379|"~     Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines~     an array of non-invasive sensors which monitors the patient's physiological parameters~     (heart & respiration rate, perspiration, skin temperature and arm motion) designed as a~     wrist watch device.~      The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in~     hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to~     reference methods~      The proposed study will be consisting of two main segments:~      The primary aim of segment 1 of the study is data collection and calibration of the Hypo~     Sense sensor prototype compared to standard invasive reference glucometer.~      The primary aim of segment 2 of the study is to validate the Hypo Sense prototype~     performance in detecting hypoglycemic events.~      During the first segment of the study we intend to collect in parallel measurements of blood~     glucose using reference method (capillary glucometer) and continuous data generated by the~     non- invasive study device during approximately 4 hours, in which a hypoglycemic event will~     be induced.~      The reference and study device data will be analyzed using multivariate regression model to~     formulate a calibration algorithm model. This model will translate the set of the~     physiological recorded parameters into detection of hypoglycemic events.~      During the second segment of the study we intend to evaluate the validity of the Hypo Sense~     sensor ability to detect hypoglycemic events compared to standard invasive reference method~     (capillary glucometer).~   "
63557|NCT02225366|"~     The goal of this clinical research study is to find the appropriate dose of LL37 that can be~     given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the~     immune system to help control the disease.~   "
63558|NCT02225353|"~     Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized~     progesterone for the prevention of preterm delivery, established through spontaneous birth~     before gestation weeks 32 (31 6/7) and 34 (33 6/7), when the pessary is inserted during~     weeks 16th and 24th and removed at 36 6/7 weeks in pregnant women at high risk of premature~     birth.~   "
63559|NCT02225340|"~     Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by~     mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles~     from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma~     LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH~     carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying~     defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9)~     regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.~      The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein~     (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of~     HeFH subjects.~      The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C~     concentration variability and are associated with Lp(a) levels.~   "
63560|NCT02225327|"~     Similar to children, adults frequently visit outpatient clinics to get two or more kinds of~     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and~     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster~     vaccine, etc. This study is intended to evaluate the immunogenicity and safety of~     concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax)~     and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.~   "
63620|NCT02224547|"~     The purpose of this study is to perform prospective data analysis on tumor response in terms~     of local tumor control after 2 years, potential acute and late toxicity and survival in~     patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are~     medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens~     used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a~     risk-adapted approach.~   "
63562|NCT02225301|"~     Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact~     of iLook Out for Child Abuse, an online, interactive learning module about reporting~     suspected child abuse. Delivered via a learning management system to early childhood~     professionals who work with infants and young children, this study assessed iLookOut's~     effect on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting~     suspected child abuse; and 3) preparedness to protect children at risk.~      Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and~     increase self-reported preparedness of early childhood providers to report suspected child~     abuse.~      Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same~     measurements as Phase 1, and is available for use (free of charge) for all childcare~     providers in Pennsylvania at https://www.ilookoutforchildabuse.com.~   "
63563|NCT02225288|"~     This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A~     total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to~     administer one E2022 tape to designated sites.~   "
63564|NCT02225275|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     obinutuzumab can help to control CLL or SLL. The safety of this drug combination will also~     be studied.~   "
63565|NCT02225262|"~     The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients~     with early stage prostate cancer.~      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the~     CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and~     effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile~     bulb, and bowel) from receiving damaging doses of radiation.~   "
63566|NCT02225249|"~     Lung transplantation is a well established method for surgical therapy for patients with end~     stage pulmonary disease.~      The investigators seek to determine to which extent the pulmonary vascular barrier gets~     harmed during lung transplantation and whether pulmonary edema after reperfusion can be~     monitored with measurement of extravascular lung water index (ELWI).~      Additionally the investigaors are going to evaluate the correlation between ELWI and~     shedding of the endothelial glycocalyx.~      The study is designed as a prospective observational cohort study.~   "
63567|NCT02225236|"~     This project will develop and evaluate the initial effectiveness of an intervention training~     executive functioning, metacognition, and self-regulation in preschoolers attending certain~     high poverty Cincinnati preschools. Studies show that these skills are critical for school~     performance, and that children with better executive functioning have better long term~     outcomes. It is also important to intervene early when children are most likely to profit~     because their brains are rapidly developing. There are some promising programs targeting~     these skills in preschoolers, but few are available to teachers for implementation in the~     classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based~     program for the preschool classroom environment, and 2) to test the feasibility and initial~     impact of the adapted program on executive functioning and school readiness in schools with~     a high proportion of children from low income families.~   "
63568|NCT02225223|"~     The purpose of this study is to evaluate treating painful metastatic lesions in vertebral~     bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral~     augmentation (VA) prior to or following radiation therapy.~   "
63569|NCT02225210|"~     This study was designed to observe the effects of dexmedetomidine on delirium and~     haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of~     dexmedetomidine.~   "
63570|NCT02225197|"~     The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic~     radiosurgery has on tumors near the critical structures of the eye (optic apparatus).~      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the~     CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and~     effectively while sparing the adjacent optic apparatus and normal brain tissues from~     receiving damaging doses of radiation.~   "
63571|NCT02225184|"~     Background:~      - Differences in peoples genes can make them respond to drugs in different ways. Methadone~     and buprenorphine are two drugs used to treat drug addiction. A study showed that African~     Americans with a certain genetic marker did better using one kind of drug treatment over the~     other. Researchers want to see if they can repeat these findings. They also want to study~     other things that affect how well people do in treatment.~      Objective:~      - To see if certain genetic markers and other facts about a person s life can predict how~     well they do in treatment for addiction to opioids and cocaine.~      Eligibility:~      - African American adults age 18 and over. They must be former or current participants in an~     Archway Treatment Clinic study. They must have been on a stable dose of either study drug~     for at least 12 weeks. They also must have given urine samples regularly for at least 10~     weeks.~      Design:~        -  Participants will come to the clinic for 1 visit lasting about 2 hours.~        -  Participants will give 1 teaspoon of blood for genetic testing. They will be asked if~          their sample can be used in future studies.~        -  If researchers cannot get enough blood, they will do a cheek swab. This will collect~          skin cells for genetic testing.~        -  Participants will fill out 3 questionnaires.~        -  Results of genetic testing and answers to questionnaires will be kept private.~   "
63585|NCT02225002|"~     CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor~     types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell~     lung cancers. In preclinical models, activation of CD40 results in increased antigen~     presentation and induction of apoptosis. CD40 is also expressed on antigen presenting cells~     (APCs) (B cells, dendritic cells, monocytes) and is a key regulator of both cellular and~     humoral immune responses. Activation of CD40 by CP-870,893, an agonistic anti-CD40~     monoclonal antibody, enhances host immune responses and abrogates the growth of tumors~     independently of the expression of CD40 on tumor cells. Therefore, it is hypothesized that~     therapeutic intervention with CP-870,893 may be beneficial to a large number of cancer~     patients either through an immunomodulatory effect or through a direct effect on~     CD40-positive tumor cells.~   "
63586|NCT02224989|"~     This pilot project evaluates the efficacy of a mind-body awareness training intervention,~     Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for~     relative therapeutic benefit will be indicated by the difference in outcomes from pre- to~     post-intervention for PTSD as the primary outcome.~   "
63572|NCT02225171|"~     Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by~     which embryos, created through in vitro fertilization (IVF), can be screened for genetic~     conditions or traits before they are implanted into a woman s uterus. Within the past few~     years, a controversial non-medical use of PGD has gained recognition as having possible~     significant ethical implications. Non-medical sex selection (NMSS) describes the use of PGD~     technology to choose the sex of a child for social, as opposed to medical, reasons. In the~     US and a select few other countries, it is legal to use NMSS for family balancing, or the~     intentional selection of an underrepresented sex to balance a family where the majority of~     the children are of one sex. Proponents of family balancing believe that NMSS is an~     expression of reproductive autonomy and is ethically acceptable on those grounds. Opponents~     are more likely to cite beneficence (toward the existing children and the potential future~     child) and justice (resource allocation and access, for example) as the basis for concerns~     around NMSS and family balancing specifically. In the US and other countries, healthcare~     providers (HCPs) are often the gatekeepers to this technology. There is little research~     exploring the experiences of HCPs with PGD and NMSS. The Moral Experience framework (Hunt~     and Carnevale, 2011) is useful for understanding the potential concerns of HCPs as well as~     their feelings and behaviors evoked by lived and hypothetical experiences around NMSS. Also~     of interest is how HCPs feel that decisions about NMSS are made and their preferences as to~     how they should be made. Finally, there is concern that NMSS may be the first in a line of~     non-medical uses for PGD and that a slippery slope toward what some describe as designer~     babies will follow. We are interested in eliciting the traits that HCPs believe are~     hypothetically appropriate or inappropriate for PGD and how they make the distinction.~     Interviews with HCPs (OBGYNs and reproductive endocrinologists) on these topics will be~     transcribed and subjected to thematic analysis in order to identify common themes. An~     understanding of the experiences and attitudes of this stakeholder population can help~     clarify current issues at individual, societal, and global levels and future directions for~     research and policy.~   "
63573|NCT02225158|"~     Background:~      Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide.~     It is caused by a bacteria that enters through the lungs and can spread elsewhere in the~     body. People with latent TB have the bacteria that lie dormant but can become active and~     cause disease. These people are offered treatment to prevent development of active TB.~     Worldwide, a lot of people with LTBI also have a parasitic worm called a helminth that can~     stay in the gut or the blood. These parasites can affect the immune system and cause~     diseases like TB to become worse. Researchers want to see how helminth infection makes it~     harder for people to fight TB infection.~      Objectives:~      - To study how the immune system of people with latent tuberculosis infection (LTBI) acts to~     prevent development of active TB. Also, to study how helminth infection might affect this~     immune response.~      Eligibility:~        -  Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB~          Gold.~        -  No evidence of infections like Hepatitis or HIV~        -  Pregnant subjects and subjects taking medications that suppress the immune system are~          not eligible.~        -  Have not received prior treatment for LTBI. Participants might be still eligible if~          prior treatment for active TB has been received~      Design:~      Screening phase:~      - Participants will be screened with medical history, physical exam, and blood tests for~     other infections/conditions which might affect the immune system. They will have testing for~     active TB i.e. blood testing as well as testing of their spit, scans and X-rays.~      Baseline phase:~        -  Only eligible participants will be entered into the study.~        -  Participants will have interviews, medical history, and physical exam.~        -  Blood will be drawn from an arm vein for testing.~        -  Participants will collect stool samples at home for 3 days in a row to test for~          helminth infection..~        -  Participants may have apheresis. Blood cells are removed by needle. They pass through a~          separator machine which returns everything but the cells back to the participant.~        -  Participants may have procedures at the start and end of the study that let researchers~          look into the lungs and collect cells.~      Study phase, about 2 years:~        -  All participants will be offered treatment for LTBI which lasts 6-9 months.~        -  Participants being treated for LTBI will have about 11 study visits. They will visit~          monthly for 9 months while on treatment, then 6 and 12 months after treatment.~        -  Participants not eligible/refusing treatment for LTBI will be made aware of active TB,~          then have 3 other visits, about 6, 12, and 24 months after the baseline visit.~        -  Participants who have helminth infection will receive appropriate treatment.~        -  All participants will have blood drawn at each visit.~   "
63574|NCT02225145|"~     Background:~      - Some treatments for cancer or other diseases can lead to infertility in women. These~     treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They~     are called gonadotoxic therapies. Women can now have their eggs frozen before they have~     these treatments. This may allow them to get pregnant later. Researchers want to learn more~     about this technology and processes.~      Objectives:~      - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about~     the effects of these therapies.~      Eligibility:~      - Women at least 18 years old who are past puberty and before menopause. They must be~     scheduled to have gonadotoxic therapies.~      Design:~        -  Participants will be screened with medical history and blood and hormone tests. They~          will also have a physical exam and transvaginal ultrasound.~        -  Ovary stimulation: participants will have medications injected under the skin. These~          increase the chance of fertility. This phase will take about 8 20 days. Participants~          will have blood drawn and transvaginal ultrasound daily or every other day. Some~          participants will also have blood thinner injected daily.~        -  Egg retrieval: participants will check in to the hospital. Eggs will be removed with a~          needle during a short surgery. Participants will be awake but sedated.~        -  Participants may stay overnight in the hospital.~        -  They will return every 1 3 days for 1 3 weeks for blood tests.~        -  Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be~          fertilized for clinical use) will be used for research. Participants can use their eggs~          in the future at outside, private fertility clinics to try to become pregnant. If the~          eggs are stored for more than 5 years, participants must pay for storage.~   "
63575|NCT02225132|"~     Background:~      - Sickle cell disease (SCD) is a blood disease. The drug hydroxyurea (HU) is approved to~     prevent pain crises in people with SCD. Researchers want to see how higher doses of HU~     affect the blood. This will help them learn about the right dosage of HU to give to people~     with SCD.~      Objective:~      - To improve hydroxyurea dosing in people with SCD.~      Eligibility:~      - People age 15 or older with homozygous SCD (HbSS).~      Design:~        -  Participants will be screened with medical history, physical exam, medication review,~          and blood and urine tests.~        -  Participants will be in the study for about 15 months.~        -  First 3 months: monthly study visits with blood and urine tests.~        -  After 3 months: participants will take HU as a capsule by mouth. If you are already~          taking HU, your dose will be increased.~        -  Within a month of starting or increasing HU: participants will keep a daily pain diary~          for 2 weeks. They will have an echocardiogram (ultrasound) of the heart, a 6-minute~          walk test. They will complete a quality-of-life questionnaire.~        -  Participants will visit every month until they reach their highest tolerated dose of~          HU. They may need to come as often as every week sometimes to closely monitor their~          blood counts. Then they will alternate a phone call one month and a visit the next. At~          the visits, participants will bring their pill bottle, answer questions about side~          effects, and have blood tests.~        -  Every 2 months, participants will have a medical history, physical exam, and blood~          tests.~        -  Every 4 months, participants will have blood and urine tests. They will also complete~          another 2-week pain diary and quality-of-life questionnaire.~        -  About 12 months after starting or increasing HU, participants will have blood tests, an~          echocardiogram, and a 6-minute walk test.~   "
63576|NCT02225119|"~     Background:~      - Maculopathies are eye conditions that affect the center of the retina. Retina health~     depends on the RPE, a layer behind the retina. A new test may measure the health of the~     central retina and RPE.~      Objective:~      - To use the focal electro-oculogram test to understand how the central retina and RPE are~     affected in maculopathies.~      Eligibility:~        -  People at least 10 years old with a maculopathy.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical and eye history and an eye exam. Pictures~          will be taken of the eyes.~        -  Their eyes may be dilated.~        -  They may have a field test. They will look into a lens and press a button when they see~          a light. First, they may sit in the dark for 40 minutes.~        -  Participants will have 1 7 visits over 18 months.~        -  Their vision will be tested and eye pressure measured.~        -  Their pupils will be dilated with eye drops and researchers may take pictures of the~          retina and the inside of the eye, and measure the thickness of the retina.~        -  Participants will have an electro-oculogram. They will look at a 2 LED lights and~          follow them back and forth for 10 seconds once per minute. Participants will be in~          darkness for 15 minutes and in light for 20 minutes. One skin electrode will be placed~          on the nose and one next to the eye.~        -  Participants with maculopathy will also have:~        -  Field test.~        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses.~          A small metal electrode will be taped to the forehead. Participants will watch flashing~          lights and try not to blink. First, they may sit in the dark for 40 minutes.~   "
63621|NCT02224534|"~     The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV~     remodeling following ST-segment elevation myocardial infarction.~   "
63577|NCT02225106|"~     OBJECTIVES:~      Deficits in memory, attention, cognitive, and executive functions are the most common~     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is~     implicated in these neural functions and dopaminergic pathways are recognized to be~     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate~     (Ritalin ). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine~     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure~     tonic DA release provides valuable insight into the molecular basis of attention-deficit~     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding~     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging~     with [11C]-raclopride, a D2/D3 receptor ligand, before and after administering~     methylphenidate, to measure endogenous DA release in patients who are experiencing problems~     with cognition, attention and executive function in the chronic stage after TBI. In~     addition, we will use TMS to test short intracortical inhibition, a gamma-aminobutyric acid~     receptor A (GABAA) - mediated phenomenon, which is under partial DA control, as a measure of~     dopaminergic activity on and off~      methylphenidate.~      STUDY POPULATION:~      Males and females (n=30), between the ages of 18 and 55 years in the chronic stage after TBI~     who experience deficits in neuropsychological function from TBIs incurred 6 months after the~     injury, will be recruited from military treatment facilities or civilian clinics when~     presenting for clinical management of TBI or postconcussive symptoms.~      DESIGN:~        1. Study participants will be evaluated using brain MRI, psychometric measures adapted~          from the TBI Common Data Elements, attention tests and information about details of the~          injury and experience of post-concussive symptoms will be recorded. Transcranial~          magnetic stimulation (TMS) with placebo and with methylphenidate (60 mg by mouth)~          challenge will be performed to predict a stimulant response.~        2. Subjects will be studied with [11C]-raclopride PET in two imaging sessions. One session~          will be after administration of placebo and the other after methylphenidate, 60 mg by~          mouth. Both placebo and methylphenidate will be given 60 minutes prior to injection of~          [11C]-raclopride to allow for peak uptake of methylphenidate in the brain. The binding~          potential of [11C]-raclopride relative to a non-displaceable reference region~          (cerebellum), BPND, will be used as a measure of D2/D3 receptor availability. The~          difference in BPND between methylphenidate and placebo ( BPND) is used to measure of~          tonic DA release.~        3. Subjects will then be treated with oral methylphenidate, using a forced titration up to~          a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic~          tests are repeated.~      OUTCOME MEASURES:~      The primary outcome is change in information processing speed~      during neuropsychologic testing~   "
63578|NCT02225093|"~     This study evaluates how once daily enzalutamide affects the metabolism of caffeine and~     dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and~     their metabolites in plasma.~   "
63579|NCT02225080|"~     The purpose of this study is to gather information about post-market performance of DuraGen~     Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market~     clinical data to evaluate the presence of unintended residual risks associated with the use~     of DuraGen Secure that were not anticipated or identified in the animal studies, bench~     studies or clinical evaluation report.~   "
63580|NCT02225067|"~     The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH~     Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers~   "
63581|NCT02225054|"~     The purpose of this study is to determine whether a small dose of Dexmedetomidine, when~     given either intravenously or as part of the interscalene nerve block solution, prolongs~     pain relief following shoulder surgery compared to local anesthetic solution alone.~   "
63582|NCT02225041|"~     The purpose of this study is to determine the relationships between sedative exposure during~     pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and~     dose-dependent relationships between sedative exposure and neurocognitive outcomes along the~     early developmental spectrum and will control for baseline and environmental factors, as~     well as the severity and course of illness.~      Hypotheses:~        1. Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ~          even when controlling for severity of illness, hospital course, and baseline factors.~          In addition, benzodiazepines and/or ketamine will negatively affect other aspects of~          neurocognitive function.~        2. Younger children exposed to benzodiazepines and/or ketamine will have worse~          neurocognitive outcomes than older children with similar sedative exposure and severity~          of illness.~   "
63583|NCT02225028|"~     People with spinal cord injuries (SCI) are among the least physically active groups in our~     society. Approximately 1 in 4 healthy young persons with spinal cord injury (SCI) does not~     have sufficient fitness to perform many essential activities of daily living. About 50% of~     people with SCI engage in no leisure time physical activity. That is, they do not wheel or~     walk for pleasure, don't play a sport, don't exercise at home or go to a gym. As a result of~     this, cardiovascular, endocrine and metabolic conditions adversely affect the health of a~     large segment of the SCI population. Fortunately, clinic and/or laboratory-based aerobic~     conditioning and circuit training studies provide compelling evidence that people with SCI~     can improve their cardiorespiratory fitness and by doing so can partially reverse~     cardiovascular disease (CVD) risk factors, enhance Quality of Life (QOL) and improve~     elements of subjective well-being. While intensive, clinic-based, supervised exercise~     programs can improve the fitness and health of persons with SCI, the value of these findings~     for the SCI population is limited because the vast majority of people do not have access to~     these specialized programs and facilities. The gap that the present study addresses is: How~     can we extend the benefits of increased exercise and physical activity to more people with~     SCI?~      The goal of this study is to evaluate the feasibility of an individually tailored, home- or~     community-based, telephone delivered intervention that uses evidence-based behavioral and~     motivational counseling to increase daily physical activity and exercise.~   "
63584|NCT02225015|"~     This study aims to develop a follow-up telephone-based genetic counselling (FTGC)~     intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling~     in the past. Typically, when women undergo genetic testing, they receive standard genetic~     counselling prior to testing in order to fully understand the procedure and associated~     implications. If a woman's genetic test results are positive for a mutation, cancer~     prevention options are then discussed with a counsellor. However, in Canada, there is~     currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing~     guidance and support about latest risk reduction strategies. Standard care relies on women~     making contact for any follow-up questions or concerns they may have. As a result, these~     women might not have the most current information regarding genetic risk assessment and~     prevention options. Therefore, individuals are being asked to participate in this study to~     aid research about the efficacy of FTGC in women with a BRCA mutation.~   "
63587|NCT02224976|"~     The investigators propose a prospective, longitudinal, department funded study protocol to~     evaluate whether changes in energy availability, during a period of highly intensified~     exercise training, will increase bone turnover markers and decrease ovarian function and~     exercise performance, in a dose-dependent fashion in competitive female athletes.~   "
63588|NCT02224963|"~     The purpose of this randomized trial is to examine the effectiveness of a psycho-social~     Preventive Problem Solving Intervention on emotional well-being, change in future outlook,~     and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.~   "
63589|NCT02224950|"~     The study will primarily focus on evaluating the benefits of using a~     lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate~     eczema. More specifically, the study will focus on the upper limb area in these patients and~     will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can~     improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell /~     chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using~     the following four variables: an eczema severity index, amount of itching, bacteria levels~     in the affected areas of skin, and amount of water loss in the affected areas.~   "
63590|NCT02224937|"~     The purpose of this study is to evaluate the percutaneous transportation and~     pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery~     consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream~     application. Cognitive parameters are investigated using KSS, FTT and CRT tests at above~     mentioned time points.~   "
63591|NCT02224924|"~     The purpose of this study is to compare two methods that are currently used at the end of a~     CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the~     chance of air leaking out of the hole. The two techniques consist of either injecting a very~     small amount of your the blood called a blood patch into the biopsy hole or injecting a~     gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed~     into the body.~   "
63592|NCT02224911|"~     This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial~     thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer~     as well as to gather data for the design of future studies.~   "
63593|NCT02224898|"~     The research objective of this pilot study is to test the feasibility of a mobile electronic~     mindfulness therapy service for patients with definite or suspected chronic pancreatitis.~      A secondary aim will be to determine the effect of the intervention on a symptom~     severity/global assessment of improvement for patients with chronic pancreatitis. The~     investigators hypothesize that a one-month period of daily mindfulness therapy delivered via~     a phone messaging service will reduce symptoms.~   "
63594|NCT02224885|"~     This study is a prospective study in order to demonstrate the technical feasibility and~     safety of doing endomicroscopic imaging during interventional radiology procedure in two~     main indications: lung and liver.~      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The~     proposed study is a feasibility study.~   "
63595|NCT02224872|"~     Our primary objective is to determine if it is feasible for SAA patients to be transplanted~     using non-myeloablative conditioning and post transplantation cyclophosphamide with~     partially HLA-mismatched donors.~   "
63596|NCT02224859|"~     While using the device as a cushion, the passive distribution of pressure over bony skull~     prominences of infants will protect against formation of pressure ulcers.~   "
63597|NCT02224846|"~     The purpose of this study is to evaluate the safety and effectiveness of the study drug,~     taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).~     The study will last about up to 25 months for each participant.~   "
63598|NCT02224833|"~     PHARM-PC study is based on identify potentially inappropriate prescriptions (PIP) and~     delivery therapeutic appropriateness recommendations from the pharmacist to the physician~     and about drugs prescribed for elderly and polypharmacy patients in primary care. Assessment~     of the impact of pharmacist intervention on the appropriateness of prescribing and both~     health outcomes and economic outcomes will be done.~   "
63599|NCT02224820|"~     IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor~     specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS~     antibody reducing efficacy and its safety will be studied.~   "
63600|NCT02224807|"~     This pilot/feasibility trial seeks to explore whether an acute bout of negative energy~     balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese~     postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast~     cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to~     1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary~     approaches to correct nutritional deficiencies and progressive resistance training (PRT)~     that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that~     will receive PRT and guidance to correct nutritional deficiencies plus an intensive~     intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior~     modification. This study will explore and contrast changes in body mass index (BMI) observed~     from enrollment to the time of surgery in the experimental vs. attention control arms, and~     also monitor changes in energy intake and physical activity. These changes will be studied~     in relation to the following endpoints: a) changes in select circulating biomarkers and gene~     expression related to cancer progression, hormonal status, inflammation and other~     energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers,~     e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta~     (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and~     Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because~     both tumor tissue and blood will be examined from pre-to-post-intervention, this study will~     provide exciting new data that can elucidate pathways by which energy balance affects breast~     cancer progression. Although longer term weight loss is recommended for overweight and obese~     breast cancer survivors, it is not known whether placing the body in a state of negative~     energy balance will have a favorable impact on the tumor. If beneficial changes in tumor~     biology and the host environment occur with short-term, pre-surgical weight loss, this study~     provides proof of concept that weight loss may offer an acceptable and complementary~     treatment option that could be combined with standard therapies.~   "
63601|NCT02224794|"~     The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits~     associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive~     conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR~     protocol include: appropriate patient selection, bilateral percutaneous access, no general~     anesthesia, no ICU admission post procedure, and next day discharge.~   "
63602|NCT02224781|"~     This randomized phase III trial studies how well initial treatment with ipilimumab and~     nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment~     with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients~     with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed~     by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells.~     Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not~     yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and~     trametinib is more effective than treatment with dabrafenib and trametinib followed by~     ipilimumab and nivolumab.~   "
63605|NCT02224742|"~     Diabetic foot ulcers are the source of considerable suffering and cost and there are~     currently no wound care products available that have been demonstrated to improve healing,~     or that are cost effective. There have however been a small number of studies which have~     examined the use of platelets or fluid derived from platelets, either from the patient's own~     blood or from blood bank products. These have suggested some promise, but have suffered from~     technical difficulties in making a suitable wound care product or the volume of blood~     required to derive the product. It is thought that the reason why they may work is that~     growth factors released by the platelets may stimulate the wound to heal.~      This study will be a formal, randomised controlled trial to assess a new device for creating~     a wound care product which is a plug or patch comprising fibrin, white cells and platelets~     derived from 18 mls of the patients own blood. The application of this fibrin/white~     cell/platelet patch to the patients wound on a weekly basis will be compared with usual best~     care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25~     centres in the United Kingdom, Denmark and Sweden.~   "
63606|NCT02224729|"~     This phase II trial studies side effects and how well bendamustine hydrochloride,~     bortezomib, and dexamethasone work in treating patients with newly diagnosed multiple~     myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving~     bendamustine hydrochloride with bortezomib and dexamethasone may kill more cancer cells.~   "
63607|NCT02224716|"~     The purpose of this study is to evaluate the impact of a structured package (bundle) in~     reducing the use of antimicrobials and hospital stay of patients with community-acquired~     pneumonia (CAP), and no increase in mortality of these patients in different hospitals.~   "
63608|NCT02224703|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet syndrome.~   "
63609|NCT02224690|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects~     with Lennox-Gastaut syndrome.~   "
63610|NCT02224677|"~     This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial~     microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a~     series of evaluations between 0-3 years of age to comprehensively evaluate the developmental~     status of infants and toddlers with CFM. This research design will also explore specific~     pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the~     longitudinal relations between facial asymmetry and emotion-related facial movements and~     socialization; and (2) associations among ear malformations, hearing and speech deficits and~     cognitive outcomes. Results of this research will ultimately lead to future investigations~     that assess new interventions and corresponding changes in current standards of care for~     children with CFM.~   "
63611|NCT02224664|"~     This study will be an open label, dose escalation study to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses~     given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's~     disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period~     1 and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and~     dosed with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will~     not be conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD.~     Doses may be modified based on emerging safety, tolerability and PK data, but the maximum~     daily dose that will be given in any cohort will have PK predictions at steady state that~     are anticipated to be below toxicokinetic limits. An option for down titration to the~     previous dose level is available should the investigator consider that an AE is intolerable.~     Following down titration, a single up titration to the next dose level may be attempted if~     the subject remains symptom free for at least 48 hrs. Safety, tolerability and PK data of~     Cohort 3 will be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available~     safety, tolerability and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be~     reviewed prior to initiating the dosing in Cohort 6.~   "
63612|NCT02224651|"~     This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals~     are to assess the safety, tolerability and blood levels of ascending doses of multiple~     formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on~     exposure, in healthy subjects.~   "
63613|NCT02224638|"~     Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer~     wounds~   "
63614|NCT02224625|"~     Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product~     applied to see if they become sensitized to repeated applications.~   "
63615|NCT02224612|"~     Compare the fit of two pediatric face masks in children.~   "
63616|NCT02224599|"~     Patients diagnosed with progressive and/or refractory solid malignancies (SM), who have~     failed conventional therapy, and have no available, potentially curative therapeutic~     options, will be candidates for this Phase I/II study. Following confirmation of disease~     progression and/or refractoriness, eligible patients who agree to participate and sign a~     consent form will have their tumor cells/tissues and/or blood analyzed for the expression of~     a specific panel of Tumor Associated Peptide Antigens (TAPAs), including Sp17, ropporin,~     AKAP-4, PTTG1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1.~   "
63617|NCT02224586|"~     It is just an observation study. The investigates want to explore the signal changes of~     resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice~     infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin~     labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator~     of ASL is cerebral blood flow (CBF).~      The investigates assume that the children with jaundice after light therapy, ALFF and CBF~     will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were~     proved to be abnormal in MRI T1, T2 structure signal in kernicterus.~      Doctors observe the status of infants aside.Using monitoring probe can see clearly.~   "
63618|NCT02224573|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet or Lennox-Gastaut syndromes.~   "
63619|NCT02224560|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects~     with Lennox-Gastaut syndrome.~   "
63622|NCT02224521|"~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that~     reduces inflammation in cells.~      This study will evaluate three capsule and two tablet formulations to select the optimal~     formulation for further development. Safety will be assessed through clinical laboratory~     testing, 12-lead electrocardiogram (ECG), vital signs and Adverse Event/ Serious Adverse~     Event (AE/ SAE) recording.~   "
63623|NCT02224508|"~     Background: Sixty million American adults suffer from moderate to severe chronic pain. Of~     these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for~     chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This~     necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a~     large nonprofit health plan, developed and implemented opioid risk reduction strategies for~     doctors and patients in some, but not all, of its clinics. The risk reduction initiative~     achieved large opioid dose reductions, near universal documentation of care plans, and~     marked increases in patient monitoring. Rigorous evaluation of patient outcomes resulting~     from the opioid risk reduction initiative, incorporating patient perspectives, is needed to~     guide health care improvement efforts to reduce opioid risks regionally and nationally.~      Research goal: The investigators will evaluate a major health plan initiative to reduce~     risks of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced~     prescribing of high opioid doses. In 2010 the same clinics increased care planning and~     monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate~     effects of this initiative on health and safety outcomes of COT patients. We will test~     whether the initiative influenced pain outcomes; patient-reported opioid benefits and~     problems; and opioid-related adverse events.~      Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction~     initiative among COT patients using opioids long-term. The investigators will compare COT~     patients from clinics that implemented the initiative with COT patients from care settings~     that did not implement the initiative. The investigators will use survey data to assess~     patient-reported outcomes including pain severity, depressive symptoms, and patient~     perceptions of opioid benefits and problems, including validated measures of prescription~     opioid use disorder. They will interview and compare 800 COT patients using opioids~     long-term from clinics that implemented the risk reduction initiative and 800 COT patients~     from care settings that did not.~      Impact: This research will provide an urgently needed, rigorous evaluation of a major risk~     reduction initiative among COT patients. Evaluation results will guide efforts of health~     plans, clinicians and patients nationwide to ensure safe, effective and compassionate~     chronic pain care.~   "
63624|NCT02224495|"~     Exercise training, as part of cardiac rehabilitation, is effective in improving functional~     capacity and quality of life in patients with coronary artery disease. Other cardiovascular~     and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal~     muscle function, oxidative stress, vascular function, pulmonary circulation,~     ischaemia-reperfusion lesion and ventricular remodelling.~      However, the benefit of exercise training on systolic and diastolic function is~     controversial especially after acute myocardial infarction where no longitudinal study has~     evaluated diastolic function using modern echocardiographic parameters.~      The hypothesis is that a structured program of exercise training can improve systolic and~     diastolic function in patients after myocardial infarction.~   "
63625|NCT02224482|"~     The purpose of this study is to test how well an online program designed to help prostate~     cancer survivors cope with changes caused by their cancer or treatment works compared to~     standard print educational materials from the National Cancer Institute (NCI).~   "
63626|NCT02224469|"~     In this study a new means of communication for people with locked-in syndrome will be~     tested. The investigators will record brain signals directly from the surface of the brain~     by means of a completely implantable system. These brain signals are fed wirelessly into an~     assistive technology device and will control this device for communication and environmental~     control at the users home.~   "
63627|NCT02224456|"~     Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of~     liver disease that predisposes patients to the development of hepatocellular carcinoma~     (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and~     disease progression. Majority of Chinese patients are infected with genotype B and C HBV,~     which is different from Caucasian counterparts. This prospective multi-center cohort~     open-label study is designed to investigate the long-term effect of TDF on prevention of HCC~     and disease progression as well as to evaluate the efficacy and safety of long-term TDF in~     Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.~   "
63628|NCT02224443|"~     The purpose of this study is to identify the effects of different doses of dexmedetomidine~     on postoperative cognitive dysfunction in elderly hypertensive patients~   "
63629|NCT02224430|"~     This study is dedicated to achieving a better understanding of how to identify patterns that~     indicate someone might be at high risk for relapse in schizophrenia or schizoaffective~     disorder. The investigators are utilizing smartphone technology along with on body sensors~     to achieve this goal. The study will observe participants behavior in their natural~     environment for a period of 16 weeks or until a signal of relapse is obtained. Participants~     will also complete scales in a clinical research environment biweekly.~   "
63630|NCT02224417|"~     Type II diabetes is associated with a host of adverse and costly complications, including~     heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in~     amputations. For those with diabetes, glycemic control is essential to minimize~     complications but many fail at being sufficiently adherent to their treatment. The~     investigators propose to test two incentive-based intervention strategies aimed at improving~     diabetes outcomes amongst patients with uncontrolled glycemic levels. The incentives are~     tied either to processes aimed at improving blood sugar levels (glucose testing, physical~     activity and medication adherence) or directly to the intermediary outcome (blood glucose in~     the acceptable range). While process incentives are likely to provide more motivation for~     treatment adherence, as these goals may be comparably easier to meet, these incentives only~     reward intermediary outcomes and it might be more effective to reward successfully achieving~     a health outcome directly.~   "
63631|NCT02224404|"~     The primary objective of this post market clinical follow-up (PMCF) investigation is to~     evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure~     ulcers (PU).~   "
63632|NCT02224391|"~     The goal of this research study is to learn if a smartphone-delivered intervention combined~     with nicotine replacement therapy can help you to quit smoking.~   "
63633|NCT02224378|"~     Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and~     cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central~     venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after~     cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients~     with rhythm other than sinus. The aim of this study is to assess the predictability of~     PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume~     index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular~     heart surgery.~   "
63844|NCT02221622|"~     The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a~     naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's~     disease participants. The primary goal is to determine the maximally tolerated dose.~   "
63634|NCT02224365|"~     The hypothesis of this study is that the daily consumption of 75 g dried apple powder for~     twelve weeks will improve arterial stiffness and blood pressure by improving~     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering~     biochemical markers associated with cardiovascular risk and glycemic control compared to a~     macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with~     prediabetes or type 2 diabetes who are overweight or obese will be included in the study.~     After a two-week run-in phase, eligible men and women will be randomly assigned to one of~     two treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve~     weeks. After an initial telephone screening, all participants will be requested to report to~     the study site for their first visit. On the first visit (screening), participants will be~     provided with verbal and written explanation of the project. They will then be asked to sign~     an informed consent form, followed by measuring fasting glucose levels and a medical history~     questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be~     performed for medical history, medication use, dietary intake, and physical activity.~     Qualified participants will be scheduled for their second visit two weeks later (actual~     baseline data collection) and randomly assigned to their treatment group. On the second~     (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function~     will be measured followed by blood draw and urine collection. Anthropometrics will be~     measured. Participants will be provided with their assigned treatment and will receive~     standard instructions on how to fill out daily diaries for their treatment, and for food and~     physical activity records. Blood pressure, vascular function, blood draw, urine collection,~     and anthropometric, body composition, diet, and physical activity assessments will be~     repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular~     measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled~     room in the supine position after an overnight fast and 12 hours after the abstinence of~     caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.~   "
63635|NCT02224352|"~     Background: Over one million patients in the US are estimated to undergo mechanical~     ventilation every year, and approximately 300,000 of them fail attempts at weaning. The~     morbidity and mortality of these patients is greater than in patients who are successfully~     weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation~     have the potential to benefit society both in terms of human suffering and cost.~      Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by~     recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment~     occurs relatively late during a weaning trial. The knowledge that (a) expiratory muscle~     recruitment can assist inspiration, (b) the recruitment of the expiratory muscles is delayed~     during weaning, and (c) that the respiratory muscles in patients requiring mechanical~     ventilation are in a catabolic state raises the possibility that strategies designed to~     produce an early recruitment, and improve the strength, of the expiratory muscles could~     improve weaning outcomes in difficult to wean patients.~      The current investigation, which will be conducted in healthy subjects and in ambulatory~     patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1~     and 2), and in patients who are difficult to wean from mechanical ventilation at RML~     Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel~     triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular~     electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study~     the physiological (respiratory) responses to such stimulation in assisting respiration in~     healthy subjects, in ambulatory patients with COPD and in patients requiring pronged~     mechanical ventilation.~   "
63636|NCT02224339|"~     Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without~     neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical~     risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional~     speckle tracking strain indices).~      Primary Aims:~        1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking~          strain imaging for detection of carotid plaque:~             -  To determine the feasibility and safety of Carotid CEUS and Two-dimensional~               speckle tracking strain imaging SE .~             -  To determine if carotid CEUS and two-dimensional speckle tracking strain imaging~               findings are associated with coronary angiographic results in those patients~               undergoing clinically indicated cardiac catheterization.~             -  To determine the diagnostic accuracy of CEUS in identifying a vulnerable~               atherosclerotic plaque and neovascularization compared to carotid MRI, in a subset~               of patients.~        2. Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking~          strain imaging for prediction of MACE:~             -  To determine if plaque identification (with or without neovascularization) on~               Carotid CEUS SE can improve the overall prediction of MACE over stress echo~               results alone~             -  To determine if Carotid ultrasound two-dimensional speckle tracking strain indices~               can improve the overall prediction of MACE over stress echo results alone.~             -  To determine if the detection of plaque neovascularization by Carotid CEUS is an~               independent predictor of MACE (over clinical risk factors, stress echo wall motion~               results, and carotid ultrasound two-dimensional speckle tracking strain indices).~   "
63637|NCT02224326|"~     In its long preclinical course, AD shows a spreading pattern of specific pathology in a~     uniform sequence of predictable steps including brainstem nuclei in early stages. Many of~     these nuclei which are early involved in AD take equally part in the afferences of the Xth~     cranial nerve, the Vagus nerve. A method for the functional assessment of Vagus-related~     nuclei in the lower brainstem is the technique of somatosensory evoked potentials of the~     Vagus nerve (VSEP). This method targets the accessibility of early functional changes by~     evoked potentials on one hand and the early affection of specific brainstem nuclei~     comprising Vagus afferences in the course of AD on the other hand. The method of VSEP takes~     advantage of the transcutaneous stimulation of the auricular branch of the Vagus nerve~     (ABVN) which is presumed to be the only sensory part of this nerve innervating parts of the~     outer meatus acoustics at the tragus. This cutaneous branch was shown to gain access to~     Vagus afferences via brainstem regions which are affected in the course of AD. VSEP~     latencies in AD were shown to be significantly longer as compared to healthy controls. Yet,~     if VSEP really are suited for the early detection of AD is still not known.~      Functional near-infrared spectroscopy (fNIRS) measures changes in cerebral oxygenation by~     means of near-infrared light using wavelengths of 650-850 nm. The principle of fNIRS is~     based on the principle that regional neuronal activation of the brain leads to an increase~     in metabolism and oxygenation of brain tissue in that region which is accompanied by an~     elevated regional cerebral blood flow. In AD, there is a growing body of literature~     reporting deviant fNIRS activation patterns for a variety of tasks. For example, it was~     shown that the fNIRS activation pattern in frontal and parietal cortex areas in subjects~     with AD performing the line orientation paradigm is clearly different from healthy controls.~     Yet, if fNIRS is suited as a means of early detection of AD is not known.~      Therefore we aimed at testing the predictive value of VSEP and fNIRS in the early detection~     of AD. The hypothesis to be tested within this study states that subjects developing AD or~     MCI within an observation period of 6 years depict longer VSEP latencies, a different fNIRS~     oxygenation pattern and a lower performance in neuropsychologic rating below the level of~     dementia at baseline than those who remain cognitively stable.~   "
63638|NCT02224313|"~     The purpose of this study is to compare the vaginal health between premenopausal and~     postmenopausal women before and after using oral estradiol for 14 days then estradiol~     and progesterone for 14 days.~   "
63662|NCT02224001|"~     For achieving the desired refinements in Asian patients, sufficient septal cartilage must be~     needed for the ieal tip projection and lengthening of the nose by the septal extension~     graft, columellar septal strut graft, and onlay tip graft, shield graft. Actually there are~     many cases having insufficient septal cartilages in Asian augmentation rhinoplasty.~      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut~     complex in a flag-like shape : using only the septal cartilage as an elongated columellar~     septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the~     elongated columellar septal strut graft without the septal extension graft to achieve the~     desired the result.~   "
63842|NCT02221648|"~     The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA~     (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.~      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A~     into erector spinae muscles (extensors of the spine) can relieve low back pain through~     anti-spasm and analgesic effect of botulinum toxin.~   "
63639|NCT02224300|"~     Aims are:~        -  develop an Internet-based education programme about venous leg ulcer nursing care (ELC)~        -  evaluate the clinical, cognitive and economical outcomes of education programme~      Research questions are:~      1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg~     ulcer nursing care, theoretical knowledge level and practical knowledge)?~      Hypotheses for research question 1 are:~        1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical~          knowledge) than those who will not use the ELC.~        2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing~          care than those who will not use the ELC.~      2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?~      Hypotheses for research question 2 are:~        1. Ulcer healing progresses better among patients who are taken care by nurses using the~          ELC.~        2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.~        3. Nurses using the ELC will use mire adequate treatment supplies than those who will not~          use the ELC.~      3. What are the economical outcomes (treatment time and supply usage) of ELC?~      Hypothesis for research question 3 is:~      1. The economical expenditures will be lower among nurses using the ELC.~      The ultimate aim is to promote evidence-based nursing care among patients with venous leg~     ulcer.~   "
63640|NCT02224287|"~     This is a prospective randomized trial to study the effect of assigning the control of the~     fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist.~     Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose~     parameters (cumulative absorbed dose and dose area product). From exposure data, entrance~     skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in~     this study will be total fluoroscopy time for the procedure. A secondary outcome will be the~     ESD. The investigators will further analyze the contribution of clinical predictors (e.g.~     stone size/location) and procedural predictors on fluoroscopy times and ESD.~      It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating~     surgeon is controlling the activation of the x-ray beam.~   "
63641|NCT02224274|"~     There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid~     (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after~     cardiac arrest as in normothermic patients. The reasons for this are probably slower~     gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take~     action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism~     we expect its effect to be good even in patients with therapeutic hypothermia after cardiac~     arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous~     coronary intervention will be randomised into two groups. One will be treated with ASA and~     clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before~     and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will~     be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the~     groups will be analysed.~      Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with~     clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia~     and percutaneous coronary intervention (PCI).~   "
63642|NCT02224261|"~     Objective: To determine the effectiveness of physical therapy on the axillary web syndrome~     in improving pain, reducing swelling and increasing mobility of the shoulder. Design:~     randomized single-blinded controlled trial. Follow-up: five physical therapy assessments:~     pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.~     Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing~     unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in~     Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two~     groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy~     composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm,~     specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible,~     in conjunction with progressive active and action-assisted arm exercises; Control group:~     progressive active and action-assisted arm exercises. 9 physical therapy sessions.~   "
63643|NCT02224248|"~     The purpose of this study is to investigate if including fitness testing in preventive~     health checks increase cardiorespiratory fitness and motivation to change physical activity~     behavior compared with preventive health checks without fitness testing.~   "
63644|NCT02224235|"~     Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate~     COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography~     (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug~     eluting stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets~     for one week followed by aspirin, while patients implanted with ZES (Group 2), will receive~     Dual anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.~      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).~     Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent~     procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one~     month follow up.~   "
63645|NCT02224222|"~     The purpose of this study is to assess the impact of frailty as a multidimensional risk~     factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining~     patient frailty a multimodal questionnaire has been developed including measurement of~     psychological, socioeconomical, neurological and behavioral aspects. This study also~     features an investigation of the possible relationship between sudden regional weather~     changes, individual meteorological susceptibility of the patients and the outcomes of adult~     cardiac and vascular surgery.~   "
63646|NCT02224209|"~     The purpose of this study is to evaluate the efficacy and safety of staged carotid~     angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with~     carotid artery stenosis at high hyperperfusion risk in peri-procedural period.~   "
63647|NCT02224196|"~     Comparison of peak airway pressure and gastric insufflation in manual ventilation and~     pressure-controlled ventilation with facemask during anesthesia induction in children.~   "
63713|NCT02223325|"~     -  To compare the prognosis of acute pancreatitis between geriatric and other adult~          patients~        -  To evaluate the efficacy of various prognostic scores in geriatric patients with acute~          pancreatitis~   "
63648|NCT02224183|"~     Chronic low back pain (cLBP) is the most common pain condition in the military, causing~     substantial physical and psychological suffering, reduction in force readiness, and high~     economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting~     it may be effective in reducing pain intensity, improving back-related function, and~     lowering pain medication use. Multiple differences exist between civilian and military~     populations with cLBP, making it necessary to adapt and test yoga for cLBP in military~     populations. This study's primary aim is to evaluate the effectiveness of yoga for reducing~     pain in military personnel and Veterans with cLBP through a structured, reproducible 12-week~     series of hatha yoga classes, supplemented with home practice, compared to an education~     group. Additionally, the enormous mental health burden often shouldered by returning~     military personnel presents another important distinguishing factor. Thus, the study's~     secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (PTSS).~     The third aim is to evaluate the cost-effectiveness of yoga for cLBP at 3 months and 6~     months from the perspective of the provider, the Veteran, and the Veterans Health~     Administration. The fourth and final aim is to evaluate the effect of back pain and yoga on~     marital and family functioning. The proposed RCT will (1) establish a structured~     reproducible yoga protocol uniquely suited to Veterans populations with cLBP; (2) develop~     web-based delivery systems to assist Veterans in yoga home practice; (3) increase our~     knowledge of the feasibility and impact of yoga for Veterans' cLBP and psychological~     comorbidities. These results will help determine whether yoga is an effective modality for~     addressing cLBP in a Veteran population.~   "
63649|NCT02224170|"~     The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on~     postoperative quality of recovery after laparoscopic cholecystectomy~   "
63650|NCT02224157|"~     The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is~     effective in treating asthma when used 'as needed' in patients with milder asthma. The~     efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler~     twice daily plus terbutaline Turbuhaler 'as needed'~   "
63651|NCT02224144|"~     The purpose of this study is to test whether active vitamin D (calcitriol) protects bones~     from weakening and protects blood vessels from calcium deposits over the first year of~     kidney transplantation.~   "
63652|NCT02224131|"~     Patients' responses to oral antiplatelet therapy are subject to variation. Bedside~     monitoring offers the opportunity to improve outcomes of intracranial aneurysm patients~     undergoing stent deployment by individualizing therapy.This trial is designed to demonstrate~     the superiority of a strategy of platelet function monitoring with dose adjustment in~     suboptimal responders as compared to a more conventional strategy without monitoring and~     without dose adjustment to reduce the primary end point evaluated 6 months after stent~     deployment in patients with intracranial aneurysms.~   "
63653|NCT02224118|"~     The purpose of this study is to investigate the safety (adverse events, weight, blood~     pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead~     electrocardiography, and laboratory tests) of CNTO 3649 when administered once by~     subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese~     participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in~     the body or the body's insulin is not effective, resulting in high blood sugar, increased~     thirst and urine, and many other side effects).~   "
63654|NCT02224105|"~     The general aim of the current study was to investigate the safety and tolerability, and~     pharmacodynamics (endotoxin-induced inflammatory response of a single intravenous bolus~     administration of 2 ng/kg body weight Escherichia coli lipopolysaccharide (LPS)) of BI~     653048 BS H3PO4 capsules in healthy male subjects following oral administration of multiple~     rising doses of 25 mg to 200 mg over three days compared to the active comparator~     prednisolone and placebo.~      Pharmacodynamics were assessed by investigating the influence of LPS administration on~     inflammatory parameters. More specifically, it was evaluated whether and to what extent the~     symptoms induced by LPS challenge can be attenuated by ascending BI 653048 BS H3PO4 doses~     using prednisolone as positive control and placebo as negative control. A secondary~     objective was the exploration of pharmacokinetics of BI 653048 BS, the investigation of~     other pharmacodynamic parameters (biomarker) and of the tolerability of LPS.~   "
63655|NCT02224092|"~     The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin~     multimineral with phytonutrient product vs. placebo on heart health risk factors following~     twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the~     multivitamin multimineral with phytonutrient product vs. placebo following twice-daily~     consumption for eight weeks.~   "
63656|NCT02224079|"~     Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)~     doses of BIIB 722 CL~   "
63657|NCT02224066|"~     A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected~     for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated~     previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and~     Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet~     reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus~     DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following~     TAVI.~   "
63658|NCT02224053|"~     This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of~     AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will~     receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in~     Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be~     separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The~     study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole~     (proton pump inhibitor) on AZD9291 exposure~   "
63659|NCT02224040|"~     The current study goal is to examine the effect of Cephalosporins, Azithromycin and the~     combination of both on typhoid fever therapy in endemic population.~      The investigator's hypothesize that the combination of azithromycin and ceftriaxone may~     prove superior to each drug, ceftriaxone or azithromycin, alone.~   "
63660|NCT02224027|"~     The use of laryngeal mask airway or i-gel to manage airway may improve success rates,~     especially in difficult situations more than tracheal intubation.~   "
63661|NCT02224014|"~     Study to investigate the safety and the efficacy in patients with insomnia, receiving~     Lendormin D tablet under condition of normal clinical practice.~   "
63663|NCT02223988|"~     Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks~     of morbidity and mortality for patients who require mechanical ventilation.~      VAP is associated with the contamination and colonization of bacteria in the lower airway.~     These bacteria may be present in the lower airway by the aspiration of oropharyngeal~     secretions. Therefore limiting the amount of secretions that pass the glottis and enter the~     airway is paramount.~      Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to~     manage breathing. These tubes may have a distal cuff which sits within the trachea. When the~     cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube~     thereby limiting the amount of secretions entering the lower airway. These secretions may~     leak around the cuff and cause tracheobronchial colonization. It has been shown that removal~     of secretions that pool above the cuff via dorsal lumen suction leads to a decreased~     incidence of VAP.~      The purpose of this study is to measure the effect of suction above the cuff tracheostomy~     tubes related to VAP incidence~   "
63664|NCT02223975|"~     Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval~     skin disorders are common and the diagnosis of these conditions can be difficult. Reliable~     discrimination between benign vulval skin conditions, precancerous conditions or vulval~     cancer often requires tissue biopsies. In addition the monitoring of patients with vulval~     disease at risk cancerous change is currently limited to visual assessment often~     supplemented by multiple invasive tissue biopsies. There are currently no established non~     invasive tests available for the diagnosis of vulval skin diseases.~      The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform~     infrared spectroscopy are non invasive diagnostic tools that use the interaction of light~     within tissues to identify the chemical composition of different tissues. The use of these~     tools may reduce the need for invasive biopsies to diagnose and monitor women with vulval~     skin disease.~      The aim of this project is to explore the use of vibrational spectroscopic techniques in the~     diagnosis of vulval skin disease. This will be achieved by performing vibrational~     spectroscopy on samples of tissue previously taken from women with vulval skin disease~     treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy~     will be compared with the routine tests and the accuracy of spectroscopy determined.~   "
63665|NCT02223962|"~     Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant~     a hospitalization. During the hospitalization, patients are extremely physically inactive~     with only a limited recovery one month after discharge. Physical inactivity is associated~     with negative health benefits. Therefore intervening in the period after and exacerbation~     seems useful to improve the levels of physical activity. Physical activity counseling and~     real-time feedback have already been applied in stable patients with COPD, with beneficial~     effects.The present study will investigate whether this specific intervention will help to~     improve the activity level in patients after an acute exacerbation. Further we investigated~     the effects of the intervention on improvements in functional exercise capacity.~   "
63666|NCT02223949|"~     The purpose of this study is to investigate whether mechanical cervical ripening (using the~     Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in~     overweight and obese women undergoing labor induction.~   "
63667|NCT02223936|"~     Prospective, multicenter study following for 2 years, 250 children who presented during the~     first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of~     Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose~     pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of~     each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those~     children using a scale.~   "
63668|NCT02223923|"~     This study will investigate the use of a new drug targeting the DNA repair pathway AZD6738,~     an ATR inhibitor). Many tumours have lost important DNA repair functions and rely more~     heavily on a few remaining repair pathways to survive. Preclinical studies indicate that, in~     these tumours, preventing the function of the remaining pathways will lead to tumour cell~     death, while sparing normal cells. This study aims to investigate the safety and~     tolerability of the new drug in patients with advanced cancer, as well as in combination~     with palliative radiotherapy, where the drug may increase the effectiveness of radiotherapy~     by preventing repair of the radiationinduced DNA damage. As the drug has only been given to~     a small number of patients, the study will focus on safety and finding the correct dose to~     proceed to further studies, although preliminary signs of drug activity will also be~     examined.~      The initial part of the study will administer increasing doses of the drug to groups of~     patients with advanced cancer who have no standard anticancer treatment options available.~     Testing will establish whether the drug levels in the body and tumour are adequate for the~     drug to have an effect, and any toxicity will be assessed. After the recommended dose is~     established, the recommended dose schedule will be stablished by trialing different~     schedules. Participants will be tested to see if their tumours lack the main DNA repair~     pathway (those who are predicted to have a better response to this drug). Finally, the drug~     will be given to patients with advanced cancer who require a course of radiotherapy for~     symptom control - the drug will be tested at different doses and with different doses of~     radiotherapy.~      Side effects will be monitored and tests will establish whether the drug is enhancing the~     radiotherapy effect in the tumours or normal tissues.~   "
63669|NCT02223910|"~     Background: The technology of brain-computer interfaces (BCI) enables the monitoring of~     brain activity and the generation of a real-time output about specific changes in activity~     patterns. The recorded subject receives a feedback about the neural activity associated~     his/her efforts and can thus learn to voluntarily modulate brain activity. There is~     accumulating evidence that training of motor cortex activations with brain-computer~     interface systems can enhance recovery in stroke patients. Here we propose a new approach~     which trains resting-state correlates of motor performance instead of activations related to~     movements. Previous studies have shown that the more resting-state alpha oscillations in the~     motor cortex are coherent with the rest of the brain, the better stroke patients perform in~     motor tasks. Furthermore, observational studies have suggested that training of alpha-band~     coherence in the motor cortex with neurofeedback has beneficial effects on motor~     performance.~      Objective : This randomized controlled study aims to test the usefulness of training~     functional connectivity between the motor cortex and the rest of the brain with a~     brain-computer interface in patients with chronic stroke. We hypothesized that this network~     variant of neurofeedback training will lead to region and frequency specific increases in~     functional connectivity and to an improved function of the affected upper extremity.~      Methods : 10 patients with chronic stroke and significant unilateral deficit of upper~     extremity motor function will perform two periods of neurofeedback training in a randomized~     cross-over design. In one period, they will train alpha-band coherence between intact areas~     around the affected motor cortex and the rest of the brain. In a control period, they will~     train alpha-band coherence between a control region not directly related to motor function~     (the medial prefrontal cortex of the healthy hemisphere) and the rest of the brain. In each~     period, two training sessions per week will be performed for 4 weeks. The periods are~     separated by at least 4 weeks. Oscillations in the brain will be reconstructed from 128 EEG~     channels using an adaptive spatial filter and the coherence between the target area and the~     rest of the brain will be calculated in real time. Coherence magnitude will be displayed in~     the form of a cursor on a computer screen.~      Significance: This study may provide causal evidence for a role of functional connectivity~     in motor learning and may lead to new strategies for rehabilitation.~   "
63670|NCT02223897|"~     Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after~     orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment~     for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal~     stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions~     after liver transplantation.~   "
63671|NCT02223884|"~     This is the phase II, single-arm, single-center study assessing the efficacy of weekly~     docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or~     metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end~     point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and~     secondary end point includes disease control rate, progression free survival, overall~     survival and safety.~   "
63672|NCT02223871|"~     This was a single-center study using induced blood stage malaria infection to characterize~     the activity of ACT-451840 against early Plasmodium falciparum blood stage infection~   "
63673|NCT02223858|"~     Arthritis is a painful, disabling condition that disproportionately affects African~     Americans. Existing arthritis treatments yield only small to moderate improvements in pain~     and are not effective at reducing racial disparities in arthritis pain. According to the~     biopsychosocial model of pain, there is a need for novel interventions that target~     psychosocial factors associated with arthritis outcomes and disparities in outcomes.~     Evidence from the field of psychology suggests that an intervention designed to develop a~     positive mindset has the potential to improve pain and functioning and reduce racial~     disparities in patients with arthritis. Interventions to foster a positive mindset have been~     developed for clinical patient populations but have not yet been fully tested in patients~     with arthritis or in Veterans, nor have their effects on racial differences in clinical~     outcomes been examined. This study will address these gaps by testing the impact of an~     evidence-based positive activities intervention on pain and functioning in African American~     and White Veterans with knee arthritis.~   "
63674|NCT02223845|"~     To investigate whether listening to music at the time of embryo transfer reduces anxiety~     levels in women undergoing assisted conception treatment.~   "
63675|NCT02223832|"~     This is a study to evaluate the relative pharmacokinetic properties and the tolerability and~     safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after~     single-dose administration.~   "
63676|NCT02223819|"~     The study is designed to determine the 32 month rate of distant relapse in patients with~     uveal melanoma who are at high risk of recurrence following definitive therapy with surgery~     or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and~     disease specific survival in this patient population.~   "
63677|NCT02223806|"~     To determine whether there is a difference in effectiveness of routine uterine tonus~     assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered~     by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal~     and neonatal outcomes.~   "
63678|NCT02223793|"~     The overall goal of the present project is to contribute to new knowledge about the effect~     of a low threshold population screening system for cardiovascular risk factors in Norway.~     Further, this project aim to study if identifying high cardiovascular risk itself may lead~     to beneficial changes in health behaviors such as physical activity, diet, tobacco and~     alcohol behavior together with reduced risk score of cardiovascular disease, across~     socioeconomic status. This fall, a nationwide, free screening of cardiovascular risk factors~     will be conducted in 150 pharmacies in Norway. All participants that consent to participate~     will measure full lipid-profile, blood pressure, HbA1c, body weight and height by health~     care providers in pharmacies. Based on their measurement levels, participants will be~     stratified into either a low or a high risk group. In the high risk group, participants will~     further be randomized to either the intervention group or one of the two control groups.~     Participants in the intervention group will be informed about all their measurement levels~     with comparison to the recommended levels. Contrary, participants randomized to the two~     control groups will have delayed information of their measured levels. Participants in the~     intervention group and the first control groups will receive general oral and written~     information about how to lower their measurement levels in 8 weeks. In the second control~     group, participants will not receive any information at the first visit. In this way the~     investigators may be able to isolate the effect of identifying high risk and high levels of~     the risk factors itself. All groups will be given a diet- and physical activity~     questionnaire at visit 1, and will be invited back after 8 weeks to once more perform the~     measurement screening and receive the same questionnaire. At visit 2, all participants will,~     after the measurement screening, be informed about their measured risk factors and receive~     information on how to lower their levels. 1 year after inclusion, all participants in the~     three groups will be invited back for a one-year follow up visit in pharmacy.~   "
63679|NCT02223780|"~     Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment~     options, progressive lung disease. Patients with COPD often have only limited access to~     palliative care. The goal of this research project is to improve the quality of life of~     patients with COPD.~      Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain~     and depression) are insufficiently alleviated. In addition, often in connection with an~     infection, patients frequently suffer from respiratory decompensation; this may lead to~     invasive interventions as well as the admission to the emergency room or an intensive care~     unit. It may ultimately lead to the death of the patient.~      Aim This study aims to show that early palliative care can reduce the number of necessary~     invasive interventions and improve the quality of life of patients with COPD. For this~     purpose, a group of patients receiving early, standardized palliative care will be compared~     to a group of patients receiving customary treatment only, without systematic intervention~     by palliative care experts.~      Significance The results of this study should make it possible to efficiently use the~     medical resources which are required for the appropriate care of patients with COPD. The~     goal is the best possible quality of life and better coordination of the measures taken,~     especially with regard to the area of acute care and the wishes of the patient.~   "
63680|NCT02223767|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with a~     facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure~     sessions were realized in virtual reality. Before and after therapy, the phobic symptoms~     were measured on a subjective, behavioral and physiological level. The placebo-controlled~     single blinded study includes 50 phobic patients, which were randomized into verum or sham~     TMS.~   "
63681|NCT02223754|"~     The purpose of this study is to test the performance of an investigational multifocal test~     soft contact lens.~   "
63682|NCT02223741|"~     This study is designed to assess effectiveness, safety and cost-utility of conventional~     rehabilitation and traditional Korean medicine conjugated rehabilitation on children with~     cerebral palsy.~   "
63683|NCT02223728|"~     Interventions to help individuals with traumatic brain injury manage their healthy lifestyle~     behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a~     telehealth lifestyle program on reductions in weight and improvements in health~     behaviors/lifestyle choices.~   "
63684|NCT02223715|"~     The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational~     study to characterize patients with CDI as well as to understand treatment and management of~     the disease.~   "
97102|NCT01786031|"~     Toward personalised treatment in early metastatic prostate cancer based on the assessment of~     biomarkers in cancer tissue samples and circulating tumour cells.~   "
63685|NCT02223702|"~     The objective of this randomized clinical study was to evaluate the effect of systemic~     administration of moxifloxacin compared to amoxicillin plus metronidazole combined with~     non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in~     6-month follow-up.~      A total of 40 systemically healthy patients with GAgP will evaluate in this randomized~     clinical trial. Periodontal parameters (plaque index, gingival index, probing depth,~     bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and~     6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg~     metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.~   "
63686|NCT02223689|"~     Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.~   "
63687|NCT02223676|"~     The purpose of this study is to investigate the effect of implementing clinical pharmacists~     in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists~     conduct medication history, make medical interaction screenings, -reconciliations and~     -reviews on unscheduled patients admitted to the Emergency Department during daytime.~   "
63688|NCT02223650|"~     The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)~     overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles)~     in children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether~     to proceed to a full-scale, longer-term randomized trial.~   "
63689|NCT02223637|"~     The Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is~     stablished to meet a post marketing commitment agreed upon with CBER to prospectively~     collect data on pregnancy exposures to Novartis Meningococcal quadrivalent CRM-197 conjugate~     vaccine.~      It is an observational study of women inadvertently immunized with the Novartis~     Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or~     at any time during pregnancy as part of routine care.~      The objective of the pregnancy registry is to evaluate pregnancy outcomes among women~     immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior~     to conception or at any time during pregnancy. The primary outcomes of interest include~     major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes~     will be collected, including spontaneous abortions and stillbirths.~   "
63690|NCT02223624|"~     Many studies have shown that exercise training is beneficial for patients with chronic heart~     failure (CHF). Heart Foundation guidelines strongly recommend regular physical activity and~     referral to a specifically designed rehabilitation program for all patients with CHF who are~     medically stable. Such programs usually comprise aerobic exercises such as walking, and~     light weightlifting with care to avoid heavy straining due to stress that this may place on~     the heart.~      Eccentric contractions are those in which the muscle lengthens as it contracts. Exercise~     involving eccentric contractions is known to increase muscle strength and this type of~     exercise also requires less oxygen. This is because it requires less power to resist~     lowering a weight than it does to lift a weight. Initial evidence suggests that this form of~     exercise has favourable outcomes in the frail elderly and those with chronic disease.~      This study aims to determine if eccentric exercise can be applied to patients with heart~     failure to increase their physical function while using less energy so that exercise is more~     tolerable for patients who complain of significant breathlessness and fatigue. This study~     also aims to determine if eccentric exercise is a safe alternative exercise option for~     patients at risk of negative events.~      The investigators propose to run a randomised controlled trial. Eccentric exercise will be~     delivered to a group of heart failure patients referred to the existing heart failure~     rehabilitation program at the Northern Hospital. The program will consist of eight weeks of~     twice weekly exercise of one hour's duration comprising eccentric exercise combined with~     walking and light weight training. This will be compared to a group of patients~     participating in the current exercise program consisting of light weightlifting and aerobic~     exercises for the same length and duration of exercise and also to a third group of patients~     who will be wait listed for 8 weeks. Following the completion of the eight week waiting~     period, these patients will be offered the option of joining the standard exercise program.~      The investigators expect that the eccentric exercise group will have improved walking~     capacity and quality of life compared with the traditional program and the wait-list control~     group. It is also possible that there is no difference between the eccentric and traditional~     program in terms of functional outcomes but that the participants report that eccentric~     exercise is easier.~   "
63691|NCT02223611|"~     The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in~     stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate~     the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer~     patients after the complete resection.~   "
63692|NCT02223598|"~     The purpose of this study is to determine the safety, tolerability, dose limiting~     toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological~     malignancies.~   "
63693|NCT02223585|"~     Gut microbiota are involved in the regulation of mammalian metabolic pathways through~     host-microbiota metabolic, signaling, and immune-inflammatory interactions that~     physiologically connect the gut, liver, brain, and other organs. Correlation of these~     metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe~     relationships.~      Microbiome sequencing have generated novel insights into the role of gut microbial~     composition in health and disease, but are limited in addressing the microbial contribution~     to host metabolism and the gut microbial dysbiosis in disease.~      This is an exploratory trial, aiming to examine how gut microbial conditions determine~     response to dietary challenge by measuring urine, plasma and stool metabolites resulting~     from metabolism of protein, polyamines and bile acids in combination with stool bacterial~     composition. The focus of this trial is to evaluate impact of protein based food challenges,~     based on cross-over design of two diet challenges of animal and vegan protein sources.~   "
63694|NCT02223572|"~     Due to its prevalence worldwide, osteoporosis is considered a serious public health concern.~     The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the~     US only.~      Hip fracture is associated with serious disability and excess mortality. Studies have shown~     that an initial osteoporotic fracture is a major risk factor for a new fracture. An~     increased risk of 14.8% for a secondary hip fracture has been demonstrated in people that~     have already sustained a fracture in the past 4 years (In average). These data indicate the~     major opportunity afforded by secondary fracture prevention strategies.~      By responding to the first fracture, we can reduce the incidence of second and subsequent~     fractures. However, even after longer medical follow-up according to regular standard of~     care, medical treatment and rehabilitation, the medical system has been unable to translate~     the eminent risk into an effective preventive treatment.~   "
63716|NCT02223286|"~     The purpose of this study is to understand the use of Corus® CAD in the clinical decision~     making process of patients who underwent the evaluation of chest pain or anginal equivalent~     symptoms. Specifically, to better understand whether the use of the assay in clinical~     decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic~     yield of additional tests ordered and/or invasive angiography.~   "
63845|NCT02221609|"~     The objective of this study is to investigate the efficacy of a treatment based on Movement~     System Impairment based classification (MSI) model in patients with chronic non-specific low~     back pain.~   "
63695|NCT02223559|"~     The assessment of pulmonary artery pressure (PAP) and parameters describing right~     ventricular function stand in the focus of the diagnosis and clinical management of~     pulmonary hypertension (PH). Right heart catheterization (RHC) is the gold standard method~     to measure PAP and to provide hemodynamic information on right ventricular function.~     However, due to its invasive nature, RHC is not optimal for screening and for close~     monitoring of the disease. Therefore, the development of non-invasive methods providing~     reliable PAP measurements and right ventricular functional parameters would be of major~     benefit.~      Today, the most often used comprehensive non-invasive method for these purposes is~     echocardiography. However, the method has limitations; in many cases PAP is significantly~     under- or overestimated - especially in subjects with co-existing pulmonary diseases.~     Regarding right ventricular function, although novel echocardiography parameters appear to~     be promising, they have not yet been evaluated in all forms of PH.~      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is~     considered to be as gold standard for the non-invasive assessment of right ventricular~     function. In addition, our group showed that with a special approach (vortex method), MRI~     enables the determination of PAP with physiologic accuracy, but the method has not yet been~     validated systematically in different forms of PH.~      All patients undergoing right heart catheterization in our clinic are candidates for the~     study. Excluded will be patients not eligible for MRI or declining to take part in the~     study. MRI and Echocardiography will be performed within two weeks of the RHC.~      Hypothesis:~        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad~          collective of patients with PH of diverse ethology.~        2. MRI derived right ventricular functional parameters correlate better to invasive~          measurements and to established prognostic parameters than echocardiography derived~          right ventricular functional parameters.~        3. Novel right ventricular tissue Doppler parameters add substantially to classical~          echocardiography parameters to describe right ventricular function.~   "
63696|NCT02223546|"~     Choroidal volume measured fluctuates significantly over a 24 hour time frame.~   "
63697|NCT02223533|"~     Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan~     can help control postoperative pain. Placing a wound catheter intraoperatively following~     colon surgery could optimize the control of acute pain with less consumption of opioids and~     few adverse effects.~      Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo~     laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.~      Patients were recruited and randomly allocated to wound catheter placement plus standard~     postoperative analgesia or standard postoperative analgesia alone. A physician from the~     acute pain management unit monitored all patients for at multiple points over the first 48~     hours after surgery. The primary outcome variables were verbal numeric pain scale (NRS)~     scores and amount of intravenous morphine used via patient controlled infusion.~   "
63698|NCT02223520|"~     This trial will test our hypothesis that treating parents of neonates requiring NICU care~     with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S.~     aureus from parents to their neonates.~   "
63699|NCT02223507|"~     The objective of the present study was to obtain information about the safety, tolerability~     and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two~     increasing doses in healthy elderly volunteers, following the infusion schema of a loading~     dose (1 hour) and a maintenance dose (5 hours)~   "
63700|NCT02223494|"~     Study to assess the safety of terbogrel during open-label, long-term treatment in medically~     stable or improving patients with primary pulmonary hypertension who have completed the~     12-week, double-blind randomized trial of terbogrel (protocol 528.19)~   "
63701|NCT02223481|"~     This study sought to determine whether terbogrel was an effective treatment for primary~     pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.~   "
63702|NCT02223468|"~     The microbiota represents the collections of microbial communities that colonize a host. In~     health, the microbiota protects against pathogens and maturation of the immune system. In~     return, the immune system determines the composition of the microbiota. Altered microbial~     composition (dysbiosis) has been correlated with a number of diseases in humans. The real~     role of the microbiota in transplant recipients is still unknown even though we suspect that~     it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial~     prophylaxis taken by transplant patients, as well as by inflammatory process secondary to~     ischemia/reperfusion injury.~      A number of studies have investigated the impact of liver transplantation on the intestinal~     microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver~     transplant recipients, changes in the microbiota were correlated to post-transplant~     infections. The authors suggested that the shift to pathogenic strains of bacteria due to~     the use of prophylactic antibiotics may be contributing to post-transplant complications. In~     a larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated~     marked changes in the gut microbiota post-transplantation with an increase in~     Enterobacteriaceae and Enterococcus, and reduction in Eubacteria, Bifidobacterium and~     Lactobacillus species. These changes, however, resolved over time such that by 6 months, at~     times when bacterial prophylaxis ends and immunosuppression is reduced.~      A better characterization of the impact of post-transplant therapy on the human microbiota~     has the potential to improve our understanding of the infection process and translate into~     development of new therapeutic strategies.~      The main goal of this study is to characterize intestinal microbiota and confirm the same~     bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage~     chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting~     list throughout the first year after liver transplantation. For each patient, a healthy~     CONTROL with a similar age (± 10 years) will be selected from the same family setting, in~     whom just one sample will be obtained during the enrollment phase.~      The second goal is to analyze the potential associations between microbiota flora and~     transplant outcomes during the same period.~   "
63703|NCT02223455|"~     Hand hygiene is the single most effective practice in preventing the spread of~     hospital-acquired infections. Despite the strength of the evidence, hospital staff continue~     to sanitize their hands less than half of the time required by guidelines. Effective~     interventions are needed to improve hand hygiene compliance rates among hospital staff, but~     most are of poor quality and do not examine the specific effects of individual~     interventions. This study will build a bundle of three hand hygiene interventions using a~     research design that allows for the effectiveness of each intervention to be measured~     individually and combined.~   "
63704|NCT02223442|"~     Chronic pain is defined as pain that persists after healing of the wound that caused it, and~     can occur even in the absence of any obvious pathological trigger. In our country, there is~     a growing interest in the proper management of the disease pain.~      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease~     and from 75% to 90% of patients with advanced cancer suffers from chronic pain .~      However, pain management is mostly inadequate. This study aims to assess the Italian~     clinical practice in reference to the pharmacological management of chronic pain by health~     professionals involved in the treatment of pain in some centers belonging to the Italian~     network of pain therapy.~   "
63714|NCT02223312|"~     The purpose of this study is to evaluate the safety and effectiveness of Tumor Associated~     Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of progressive~     and/or refractory hematologic malignancies (HM). We hypothesize that treatment of patients~     with relapsed and/or refractory HM, without available potentially curative treatment~     options, and whose neoplastic cells express at least one (1) TAPA of a defined panel of~     TAPAs, using low-dose cyclophosphamide (CYP) followed by an autologous, monocyte-derived,~     TAPA-pulsed DC vaccine and low-dose granulocyte macrophage colony stimulating factor~     (GM-CSF), will result in TAPA-specific T-cell responses without significant toxicities. We~     also hypothesize CD4+ T-cell and CD8+ T-cell responses generated against specific TAPAs may~     translate into clinical antitumor activity.~   "
63705|NCT02223429|"~     The overall goal of this project is to identify the genetic, hormonal, and neurobiological~     influences on paternal nurturing behavior and to determine if fathers' neural responses to~     infants can be modulated by neuropeptides known to play a role in parenting in experimental~     animal models.~      The aim is to determine if pharmacological manipulation of central oxytocin (OT) and~     vasopressin (AVP) levels influences the neural response to viewing pictures of one's own~     infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old~     children will be scanned on two separate occasions; once under the influence of OT/AVP and~     once under the influence of placebo. Fathers will be randomized to either OT or AVP, and~     order of administration of drug and placebo will counterbalanced across subjects. Fathers~     will be scanned while viewing pictures of their own and an unknown child and while listening~     to unknown infant cry stimuli.~      The investigators hypothesize:~        -  OT will augment the ventral tegmental area (VTA), ventral striatum and medial~          orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will~          augment the primary auditory cortex (AI) response of fathers to infant cries.~        -  AVP will augment the lateral septum response to viewing own child pictures.~   "
63706|NCT02223416|"~     Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared~     in healthy female volunteers.~   "
63707|NCT02223403|"~     Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and~     submaximal exercise performance in healthy adults. Investigation for similar effects in~     patients with heart failure has not previously been conducted.~      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the~     active agent or placebo, subjects with systolic heart failure underwent submaximal steady~     state exercise with gas exchange analysis followed thirty minutes later by a six minute walk~     test. Second testing sessions were performed ten days.~      There were no significant differences in the treatment and placebo arms in average oxygen~     consumption or six minute walk distance.~      In conclusion, in patients with heart failure who have ingested a single dose of~     nitrate-rich beetroot juice concentrate, there is no significant difference with regard to~     oxygen consumption during submaximal steady state exercise or six minute walk testing~     distance.~      Further study is warranted to determine the true efficacy of nitrate consumption in this~     population with adjustments in acute or chronic dosing, exercise duration, or intensity.~   "
63708|NCT02223390|"~     In this study, the investigators propose to develop Improving AIDS Care after Trauma~     (ImpACT), an intervention based on theories of stress and coping and evidence-based~     treatment for traumatic stress. The intervention will target women in South Africa who have~     histories of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to~     reduce avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk~     behaviors.~   "
63709|NCT02223377|"~     Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as~     they offer significant benefit to the patients as well as to the hospitals. Inadequate pain~     relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care~     and hence its efficiency. Opioids form the primary modality to treat moderate to severe~     pain, but can also cause significant nausea-vomiting and other side effects. Although~     hydromorphone is five times more potent than morphine, in equianalgesic doses they both~     could provide similar pain relief. They both exert no ceiling effect for their analgesia,~     and hence incomplete or inadequate analgesia is related to the appearance of side effects.~     In this study the investigators shall assess the proportion of patients who satisfy the~     outcome of 'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries,~     assessed at 2 hours after surgery. Patients would be randomized to receive either morphine~     or hydromorphone in the surgical recovery area. All personnel involved with the study would~     be blinded. The investigators will also look to assess the time to discharge and other side~     effects. This will help to choose the better drug, thereby improving pain relief and side~     effects, and also the efficiency of health care delivery.~   "
63710|NCT02223364|"~     The purpose of this study is to evaluate the hypothesis that the investigators current total~     joint regional anesthesia pathway of continuous femoral nerve block plus single-injection~     sciatic block with multimodal analgesia (MC1156-462rev0114) is more effective than two other~     pathways utilizing periarticular local anesthesia injections for numeric rating score (NRS)~     of pain with movement after total knee arthroplasty (TKA) on postoperative day 1 morning.~     The periarticular injections include one consisting of ropivacaine and the other consisting~     of liposomal bupivacaine (Exparel).~   "
63711|NCT02223351|"~     ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to~     contracting other infections because of their compromised immune system. As HIV patients~     will be taking drugs to treat the virus this study aims to see if ASP2151 would interact~     with one of the drugs that is commonly prescribed to HIV patients (ritonovir).~   "
63712|NCT02223338|"~     1. Background: Over 1 million intravitreal injections are performed annually in the United~          States. The most devastating complication related to these injections is~          endophthalmitis, with an incidence of 0.02 - 0.1% per injection. Techniques aimed at~          prevention of this complication have been studied, though emergence rates of antibiotic~          resistant bacteria in a single clinic population comparing antiseptic technique with~          iodine vs. use of post-injection second generation fluoroquinolones has not been~          reported in the literature.~        2. Objectives: The purpose of the study is to help determine the best way to prevent~          infection and limit antibiotic resistance in patients receiving eye injections.~        3. Procedures Involved (Research Interventions): After the patient is chosen based on~          inclusion criteria and agrees to participate in the study, exclusion criteria will be~          reviewed, cognizance will be determined, informed consent and HIPAA compliance forms~          will be signed. At this point and prior to the instillation of ophthalmic medications,~          a Rayon swab will be passed along the inferior fornix of the study eye while the~          patient looks up and the examiner lowers the lower eyelid. The swab will then be used~          to inoculate chocolate agar and a blood agar culture plates and a glass slide. These~          will be brought to the FMO microbiology department for culture and Gram stain. All~          Staphylococcus aureus and coagulase negative Staphylococcus species identified will be~          subjected to sensitivity testing using the Gram Positive antibiotic panel available at~          Loma Linda, with the addition of ciprofloxacin.~   "
63717|NCT02223273|"~     Phase 1: An observational study ( registry) will be conducted with the objective of~     documenting the practice of stroke treatment in brazilian and latin american hospitals.~      Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy~     to increase evidence based treatments usage for stroke patients. The hospitals will be~     randomized into two groups: the multifaceted strategy group and the usual care group.~   "
63718|NCT02223260|"~     The aim of the study is to investigate the safety and tolerability of dabigatran etexilate~     solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to~     older children and adults and to confirm dabigatran etexilate dosing algorithm for children~     aged less than 1 year.~   "
63719|NCT02223247|"~     This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced~     stage solid malignant tumors. This research is being done to find out how safe and useful~     TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy~     exists that would be curative or might provide significant benefit. TVB-2640 belongs to a~     class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they~     interfere with the body's (and the tumor's) ability to use a substance called fatty acid~     synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.~   "
63720|NCT02223234|"~     The overall objective of the proposed study is to test, among Canadian families, the~     comparative effectiveness of 2 different versions (doses) of a family-based obesity~     prevention intervention that is tailored to families' behavioural risk profile.~      To achieve this objective, we will conduct a randomized controlled trial of families with~     children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1)~     Monthly emails with general health information (Attention Control), 2) Tailored weekly~     emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4~     home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months~     post-intervention (18 months from baseline). We will examine the impact of the intervention~     on the children's body composition, weight-related behaviours, and biomarkers of diabetes~     and cardiovascular disease risk.~      We hypothesize that, compared to children in the Attention Control, children in the Email +2~     and Email +4 conditions will achieve:~        1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass~          index (BMI),over a 6-month intervention period.~        2. higher frequency of family meals, child's sleep duration, physical activity, and fruit~          and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary~          behaviour over a 6-month intervention period. (secondary outcomes)~        3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting~          insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein,~          trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a~          6-month intervention period.~      We further hypothesize that there will be no significant difference in these outcomes~     between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.~   "
63721|NCT02223221|"~     Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all~     couples and challenges both patients and clinicians technically and emotionally. IVF clinics~     see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction~     treatment with or without other infertile factors. Guidelines for evaluation and treatment~     of RPL patients include screening for uterine abnormalities, parental chromosomes,~     autoimmune antibodies and cure gynecological infections, but there are still half of RPL~     patients remain unexplained.~      The documented high incidence of chromosomal errors in first-trimester miscarriages and an~     increased rate of aneuploidy in patients with RPL has led to the theory that screening~     embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and~     serve as a possible treatment. The technology, indications of use, and even terminology for~     genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic~     diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed~     by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal~     screening or comprehensive chromosome screening, PCS or CCS, or the investigators generally~     termed PGS) based on array-comprehensive genome hybridization(aCGH), single nucleotide~     polymorphism array(SNP-array) or next generation sequencing(NGS), to be the most powerful~     technology. However, for whom this PGS technique is most suitable to achieve improved~     clinical outcome have not yet been identified by well defined, ITT based research with~     carefully selected control and adequate sample size.~      The investigators research is to determine whether in vitro fertilization (IVF)/~     intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation~     comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile~     female patients with recurrent spontaneous abortion history.~   "
63722|NCT02223208|"~     This is a multicenter study that includes two phases:~        1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to~          CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose~          escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of~          Romidepsin will be used for the subsequent phase II study.~        2. A phase II study to evaluate the efficacy (response rate, progression free survival and~          overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy~          including SCT.~   "
63723|NCT02223195|"~     Purpose and aims This as a pilot study to see which biomarkers can be found in saliva in~     children with Juvenile idiopathic Arthritis (JIA).~      The hypothesis is that children with JIA will show a different pattern of biomarkers in~     saliva than healthy children The null hypothesis is that there are no differences.~   "
63724|NCT02223182|"~     The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after~     12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated~     cow's milk allergic children and to assess the long-term safety and treatment efffect of up~     to 48 months of treatment with Viaskin Milk~   "
63725|NCT02223169|"~     Heart disease and stroke are the most common cause of death in Ireland today.One of the main~     risk factors for heart disease and stroke is high blood pressure or hypertension. Research~     has found that certain specific proteins or peptides found in foods such as dairy, meat,~     fish and eggs may promote heart health reducing blood pressure in adults with hypertension.~     The aim of this study is to investigate the potential beneficial effects egg peptides may~     have on heart health, in particular, effects on blood pressure.~   "
63726|NCT02223156|"~     The main purpose of this study is to investigate effect of Medi Yoga on quality of life,~     biomedical factors and health care consumption, and to study gender differences between~     individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional~     purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects~     their condition.~      Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood~     pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and~     CRP are positively affected, and that individuals seek less medical care.~   "
63745|NCT02222909|"~     Project CONNECT (Community-based Organizations Neighborhood Network: Enhancing Capacity~     Together) is a randomized controlled trial that involves 22 community-based organizations~     (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the~     intervention group using a constrained cluster randomization process. The remaining 11 are a~     part of the control intervention group. The intervention is a co-developed set of IT tools~     hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care~     facilities and CBO clients.~   "
63746|NCT02222896|"~     Demonstrate the reduction of bacteria on the skin~   "
63727|NCT02223143|"~     Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a~     leading cause of morbidity and mortality. Dyslipidemia has long been recognized to be the~     most important risk factor in the development of atherosclerosis in human beings. In Taiwan,~     the rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980;~     and 17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970~     and 13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor~     among a good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol~     (LDL-C) with statins has in the last decade become part of the standard treatment regimen in~     patients with dyslipidemia. However, most embarrassing, is the insufficient data for~     clinical use in Taiwan. It is necessary to have rationalized and balanced guideline for the~     management of dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic~     research data. Because all these trials were conducted in Caucasians and no large-scaled~     end-point research about the lipid lowering therapy (LLT) was published in Asians before,~     this registry study attempts to define the status of lipid lowering therapy in Taiwan and~     the effect of LLT on CVD morbidity and mortality in a large population of patients receiving~     primary or secondary prevention therapy. The medications will only depend on the decision~     made by the primary care physicians. The patient or physician can decide to be withdrawn~     from this registry at any time because of any reason. The lipid profile change, myopathy, or~     liver enzyme change after the LLT will also be recorded.~   "
63728|NCT02223130|"~     The purpose of this research study is to test a group program aimed at improving the quality~     of life of HIV+ Black men who have sex with men. The group will address ways to cope with~     discrimination and will help men examine mistrust that they may have about healthcare,~     including doctors and other healthcare providers and HIV medications. The aim is to provide~     a supportive community for HIV+ Black men.~   "
63729|NCT02223117|"~     This first-in-human exploratory IND, single-center study will assess the safety, toxicity,~     hematology, and immunogenicity of sub-therapeutic microdoses of autologous Thrombosomes®~     in healthy human subjects.~   "
63730|NCT02223104|"~     The purpose of this study is to demonstrate that the performance of Flexima Active is~     non-inferior to the performance of Sensura.~   "
63731|NCT02223091|"~     The aim of the study is to investigate the effect of a consultation training program for~     physicians on the quality of their consultations of breast cancer patients regarding~     complementary medicine. We assume that the training program might enhance the communication~     of relevant information, empathy of the physicians or satisfaction with the consultation.~   "
63732|NCT02223078|"~     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin~     gene and to be sensitive to the trophic effects of the gastrin in animal models. The~     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies~     that will bind gastrin-17, thus preventing the trophic activity of cancer cells.~   "
63733|NCT02223065|"~     The purpose of this study is to demonstrate bioequivalence of coadministered drugs on~     healthy subjects.~   "
63734|NCT02223052|"~     This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting~     of 2 phases:~      Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics~     (Food Effect) with an Extension~      This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with~     hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that~     have originated or metastasized to the liver for which no standard treatment exists or have~     progressed or recurred following prior therapy. Subjects must not be eligible for therapy of~     higher curative potential where an alternative treatment has been shown to prolong survival~     in an analogous population. Approximately 23 sites in the US and 2 in Canada will~     participate in this study.~   "
63735|NCT02223039|"~     This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose,~     multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque~     psoriasis. The objectives of this study is to investigate efficacy, safety, tolerability,~     and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to~     patients with moderate to severe chronic plaque psoriasis.~   "
63736|NCT02223026|"~     Study to investigate the effect of food on the relative bioavailability of a 2.5 mg~     linagliptin+1000 mg metformin fixed dose combination (FDC) tablet~   "
63737|NCT02223013|"~     Comparative pharmacokinetics and tolerability of two experimental extended release~     formulations and a standard formulation of BIBV 308 SE following multiple doses.~   "
63738|NCT02223000|"~     Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral~     solution of BIBV 308 SE following multiple doses, tolerability~   "
63739|NCT02222987|"~     Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100~     mg terbogrel bid.~   "
63740|NCT02222974|"~     The objective of the study is to obtain information about safety, tolerability and~     pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses~     in healthy male volunteers~   "
63741|NCT02222961|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing~     doses in healthy young volunteers~   "
63742|NCT02222948|"~     Primary Objectives:~        -  To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in~          new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS)~          patients.~        -  To evaluate multiple doses of vatelizumab for a dose-response.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of vatelizumab compared to placebo.~        -  To evaluate the pharmacokinetics (PK) of vatelizumab.~   "
63743|NCT02222935|"~     Balance problems are addressed in low back pain patients. Dearth of literature available to~     prove core strengthening or any form of back exercises improving functional outcomes or~     balance in chronic back pain patients. No studies focus on balance training in improving~     balance of low back pain patients. The authors are conducting a randomised trial comparing~     balance exercises and routine back exercise program in improving pain, functional outcomes~     and balance of the patients~   "
63744|NCT02222922|"~     To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
63748|NCT02222870|"~     The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of~     Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with~     the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6~     months to < 9 years of age.~      Objective:~        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit available sera from each subject to Center for Biologics Evaluation and~          Research (CBER) for further analysis by the WHO, the Centers for Disease Control and~          Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation~          recommendations for subsequent influenza vaccines.~   "
63749|NCT02222857|"~     Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to~     devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and~     disease course according to the diagnostic criteria proposed by the American Uveitis~     Society: (1) one or more foci of retinal necrosis with discrete borders in the peripheral~     retina; (2) rapid progression in the absence of antiviral therapy; (3) circumferential~     spread; (4) occlusive vasculopathy with arteriolar involvement; and (5) a prominent~     inflammatory reaction in the vitreous and anterior chambers.~      Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus~     (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment~     with systemic antiviral agent had been the base of the therapy of ARN for decades and such~     treatment usually result in regression of retinitis.~      However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis~     in ARN are retinal detachment and optic nerve or macular involvement by ischemic~     vasculopathy. Less frequent causes include macular hole formation, macular pucker, or~     hypotony. Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may~     occur weeks to months after the onset of inflammation due to delayed formation of retinal~     breaks, which result from the combination of necrotic retina and vitreoretinal traction.~      Therefore, application of argon laser retinopexy prophylactically posterior to necrotic~     retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal~     traction had been used to protect the healthy area from detachment. However, the results~     were varied and there is no consensus on the efficacy and indications of those prophylactic~     procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to~     access the efficacy of the treatment strategy of ARN and the correlated factors to the~     outcomes.~   "
63750|NCT02222844|"~     The IMPRESS trial aims to see whether the improved results can be achieved for patients with~     pelvic sigmoid cancers by having an MRI scan prior to surgery so that doctors can make the~     most appropriate treatment choice.~      Everyone who agrees to take part will be randomly allocated by one of the research team to~     either have standard treatment for sigmoid cancer, which involves CT-imaging of chest and~     abdomen / pelvis before surgery, or to undergo standard treatment, plus an additional MRI~     scan, before surgery. The additional MRI scan will be the only difference in approach~     between the two arms of the trial. After all imaging is obtained, patients from both arms~     will be discussed by the Multidisciplinary Team as usual.~   "
63751|NCT02222831|"~     The aims of this study are to evaluate:~        1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on~          fertilisation rates and embryo quality in standard IVF.~        2. the association between PIF status in embryo culture medium and embryo quality assessed~          by standard subjective parameters and morphokinetic development.~   "
63752|NCT02222818|"~     The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac~     Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted~     AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF~     when CAFR (Conducted AF Response) is applied.~   "
63753|NCT02222805|"~     The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or~     late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed~     with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development~     is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by~     testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with~     a high proportion of anemia at one year of age (about 75%), we can reduce the number of~     children in the study and still achieve significant results.~      Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment~     in children. Anemia is estimated by WHO to occur among 25% of all children before school~     age, and the corresponding figure in Europe is 3-9 %.~      By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume~     remaining in the placenta is transfused over to the child's body. Research shows that the~     neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months'~     supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could~     reduce iron deficiency in children at four months of age by 90%. Globally, most countries~     practice early cord clamping and the child is deprived of the placental blood transfusion.~     The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia~     at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens~     development.~      The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It~     hosts approximately 23,000 births annually.~   "
63754|NCT02222792|"~     A national, prospective, open-label, non-interventional, multicentre, controlled study~     designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder~     prosthetic removal regardless of whether or not infection is suspected. Serological test~     results will have no impact on the therapeutic approach.~      Study objective: To evaluate the diagnostic performance of an antibody detection kit for the~     serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci,~     Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the~     reference method: the bacterial culture of deep intraoperative samples.~   "
63755|NCT02222779|"~     In this trial, concentrations of transition metals of interest are quantified in surplus~     cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals~     will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating~     physicians as well as the patients will not be informed about the results of drug~     concentrations.~   "
63846|NCT02221596|"~     The purpose of this study is to identify the magnitude of muscle lipid redistribution and~     muscle oxygen use in individuals 60 years old or older following combined treatment of~     vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic~     training alone, or no treatment.~   "
63756|NCT02222766|"~     The obesity epidemic has spared no age group, including our youngest children. My and~     others' formative research shows that ethnically-diverse, low-income parents of young~     children are enthusiastic about learning general parenting skills, such as discipline~     strategies, but less interested in nutrition and physical activity. To capitalize on this~     enthusiasm, I will create and test an intervention that embeds strategies to improve child~     weight-related behaviors within a general skills parenting program.~      The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based~     intervention to prevent obesity among children age 2 through 5 years. To achieve this goal,~     my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically~     diverse, primarily low-income families. Our specific aims are to:~        1. Determine the extent to which the intervention, compared with a control condition,~          results in a smaller age-associated increase in body mass index (BMI) among children~          after a 3- month intervention and a 9-month follow-up period (primary outcome).~        2. Determine the extent to which the intervention, compared with a control condition,~          results in:~             1. Improved parent general parenting behaviors, i.e., increased use of positive~               discipline strategies.~             2. Improved parent feeding practices, i.e., increased responsiveness to child satiety~               cues.~             3. Improved child weight-related behaviors, i.e., increased sleep duration and~               physical activity, and reduced sugar-sweetened beverage intake and~               television/video viewing.~   "
63757|NCT02222753|"~     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports~     concluded aberrant immunological function was associated with colorectal cancer outcome,~     however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in~     colorectal cancer survivors is largely unknown.The investigators will explore the impact of~     immunocyte subgroup and immunologic factors on colorectal cancer disease-specific,~     disease-free and overall survival. The investigators will recruit approximately 5,000~     patients as a prospective study cohort. During follow up, the investigators will explore the~     association of these factors with outcome of patients. The investigators believe that this~     project will improve the understanding of the impact of immunocyte subgroup and immunologic~     factors on colorectal cancer outcome.~   "
63758|NCT02222740|"~     Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40~     mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady~     state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.~   "
63759|NCT02222727|"~     Introduction~      Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding around the under surface of the brain~     caused by rupture of an aneurysm arising from a blood vessel. Stroke may occur in~     approximately one third of patients as a result of narrowing of the blood vessels around the~     brain, following aSAH.~      One theory as to why this may happen is because bleeding around the base of the brain~     damages particular cells (neurons) that control blood flow around the rest of the brain.~     These neurons may control blood flow by releasing a neurotransmitter called Acetyl Choline~     (ACh). Our hypothesis is that damage to these neurons may prevent the production of ACh,~     which then causes reduced blood flow and stroke if left untreated.~      By stimulating these neurons, we aim to investigate whether it is possible to improve the~     blood flow around brain and ultimately prevent strokes in patients following subarachnoid~     haemorrhage. Donepezil, a drug widely used in dementia, inhibits the brain's natural break~     down of ACh. We predict that by increasing the amount of Ach in these neurons, donepezil may~     improve blood flow to the brain, reducing the chance of developing stroke.~      Trial Protocol~      All patients admitted to St George's hospital with a confirmed aneurysmal subarachnoid~     haemorrhage between the ages of 18 and 85 years old will be invited to participate in the~     trial. The protocol has been designed to take place around the patients' aneurysm treatment,~     which is performed under general anesthesia (GA). Recruited participants will be~     anesthetized for their aneurysm treatment and then enter the study.~      All trial participants will have a Xenon CT scan under GA to assess brain blood flow prior~     to having treatment of their aneurysm. Patients randomized to donepezil treatment will~     receive a loading dose of 20mg via a feeding tube immediately after their Xenon scan.~     Patients in the control group will not receive the drug.~      All patients in the trial will undergo repeat Xenon perfusion scanning under GA between 3~     and 4 hours after their first scan, which coincides with the completion of their aneurysm~     treatment. Those in the donepezil group will then receive a daily dose of 5 mg for a period~     of 21 days.~      All aspects of care other than those related to the trial will be the same as for any other~     subarachnoid haemorrhage patients. Patients (or their legal representative for those unable~     to consent) will be able to decline participation in the trial or withdraw at any point.~   "
63760|NCT02222714|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary~     efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human~     activated protein C (APC), in in the treatment of acute ischemic stroke following treatment~     with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.~   "
63761|NCT02222701|"~     The purpose of this study is to evaluate the clinical performance of resin composite~     restorations refurbished and compare with 2 groups of resins, 1 without treatment and~     another replaced resins acted as controls. The null hypothesis of this study is that the~     group of refurbished resins have a similar behavior to the control groups.~   "
63762|NCT02222688|"~     The purpose of the study is to investigate the safety of the investigational agent,~     cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein,~     called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth~     and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get~     rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab~     can decrease the number of CLL cells, the investigators do not know if this will work in~     humans. This drug will be given to humans for the first time in this study. Therefore, the~     goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.~   "
63763|NCT02222675|"~     Aim of the study is to test whether surgical removal of a tumor under sonographic control as~     compared to conventional method reduces the rate of resections and local relapse~   "
63764|NCT02222662|"~     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute~     at Western Oregon University (WOU) will be conducting research on the effect of a~     parent-delivered massage program on measures of autism and general development in children~     ages 6 to 11 with autism. Families will participate in an initial training, and receive 24~     sessions of ongoing support and training from a trained therapist over the first nine~     months.~   "
63765|NCT02222649|"~     A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers~     of oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the~     VDR gene would become non-responsive to supplementation.~   "
63766|NCT02222636|"~     The purpose of this study is to explore the optimal protocol for dexmedetomidine used in~     children during perioperative period.~   "
63892|NCT02220998|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks~     compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in~     participants with chronic genotype 2 hepatitis C virus (HCV) infection.~   "
63767|NCT02222623|"~     The purpose of this study is to compare the safety and effectiveness of the two different~     basal insulins commonly used for basal blood sugar control in the treatment of type 2~     diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral~     protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown~     that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control~     of blood sugar in a type 2 diabetic patient. This research is being done because the costs~     of medications for diabetic patients are very expensive. Our goal with this research is to~     show that a less expensive insulin (NPH) is as safe and effective as a more expensive~     insulin [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the~     hospital.~   "
63768|NCT02222610|"~     The purpose of this study is to assess the tolerability and efficacy of ranibizumab~     treatment administered in subjects with radiation retinopathy~   "
63769|NCT02222597|"~     The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial~     hematoma detection of head trauma patients~   "
63770|NCT02222584|"~     Physical activity (PA) is beneficial in the prevention and management of chronic disease.~     However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and~     whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the~     level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the~     effect of PA on quality of life of patients with IBD.~   "
63771|NCT02222571|"~     This formative research shows that parents of preschool-aged children are enthusiastic about~     learning general parenting skills, such as discipline strategies, but that they are less~     interested in information on child nutrition and physical activity needs. To capitalize on~     this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that~     embeds strategies to improve children's nutrition and activity behaviours within an existing~     general skills parenting program. Results from the investigators feasibility trial with 16~     Boston-area parents show that PTT is feasible for implementation and is extremely~     well-received by parents. Results are also encouraging with respect to changing parent~     feeding behaviours and children's nutrition and activity behaviours. What is not known is~     whether this program is feasible and contextually appropriate for Canadian families. Thus,~     the next step in this research program, and the overall goal of this study, is to assess~     Parents and Tots Together (PTT), a family-based intervention to prevent obesity among~     children 3 to 5 years of age, within the Canadian context.~      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with~     60 families recruited through Ontario Early Years Centres (OEYC). The investigators will~     randomize 30 families to the 3-month PTT intervention and 30 to a control condition.~      The investigators primary objective is to implement and test the feasibility and~     acceptability of PTT among families with preschool children so appropriate revisions can be~     made to adapt it to a Canadian context. The investigators secondary objective is to compare~     the following outcomes among intervention versus control participants:~        1. Parent weight-related behaviours (i.e., parent physical activity, intake of~          sugar-sweetened beverages, and television/video viewing, as well as responsiveness to~          child satiety cues).~        2. General parenting behaviours (i.e., use of positive discipline strategies).~        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of~          sugar-sweetened beverages, television/video viewing).~        4. Nutritional risk score based on a screening tool for preschoolers.~        5. Child change in body mass index (BMI), standardized to age and gender.~   "
63772|NCT02222558|"~     Low testosterone is a condition that occurs when the body is unable to produce sufficient~     quantities of testosterone. The medical name for low testosterone is hypogonadism.~     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of~     energy and mood swings. The goal of testosterone replacement therapy is to return~     testosterone levels to the normal range and relieve symptoms.~   "
63773|NCT02222545|"~     The purpose of this study is to assess the safety, tolerability, and clinical activity of~     OMS721 in subjects with thrombotic microangiopathies (TMA), which include atypical hemolytic~     uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell~     transplant -associated TMA (HSCT-associated TMA). The study will also evaluate clinical~     activity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response~     (ADA).~   "
63774|NCT02222532|"~     Infants and children undergoing cardiac surgery require mechanical support for circulation~     called cardiopulmonary bypass. The artificial pump ensures that blood flow to the body is~     maintained during surgical procedure on the heart. However, the pump circulation disrupts~     regulation of thyroid hormone. This hormone is a critical regulator of heart and circulatory~     function. Deficiencies in thyroid hormone adversely affect recovery of the heart after~     cardiac surgery. A recent study by the principal investigator showed that supplementing~     patients younger than 5 months old shortened the time spent on the ventilator (breathing~     machine) after surgery. Populations undergoing heart surgery in developing countries such as~     Indonesia are different than those in the U.S. and other industrial nations. For many heart~     defects children undergo surgery at an older age. They are then sicker for longer periods,~     and are often malnourished. These older malnourished children have lower thyroid hormone~     levels even prior to surgery, and show dramatic further drops after surgery. Shortening time~     on the ventilator should improve their recovery, and also improve overall availability of~     resources in developing countries. The formulation of thyroid hormone provided in the U.S~     and given intravenous is relatively expensive. However, a much more inexpensive formulation~     is available in Indonesia, which can be given through a tube extending from the nose to the~     stomach. We propose testing this formulation made in Korea, known as Tetronine, in two~     vulnerable populations in Indonesia: children younger than 5 months of age, and those older~     than 5 months who are malnourished. All these patients will be undergoing cardiopulmonary~     bypass for congenital heart defects. This project will be an important collaboration between~     U.S and Indonesian investigators. If successful, it will have a general positive impact on~     care of the entire population of young children undergoing cardiac surgery in developing~     countries by reducing time on the ventilator and improving access to care.~   "
63775|NCT02222519|"~     provide evidence for prevention or reduction muscle pain.~   "
63776|NCT02222506|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     diabetic foot ulcers.~   "
63777|NCT02222493|"~     The study will assess the efficacy and safety of PF-06438179 and infliximab in combination~     with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate~     response to methotrexate.~   "
63778|NCT02222480|"~     A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the~     Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in~     Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension~   "
63779|NCT02222467|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     venous leg ulcers.~   "
63780|NCT02222454|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     stage II or III pressure ulcers.~   "
63781|NCT02222441|"~     This study is designed to evaluate the potential effect of the moderate CYP3A inducer~     modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.~   "
63891|NCT02221011|"~     The effect of traditional treatment for spasticity is barely satisfactory. The shock wave~     has been used to treat the spasticity with expressively response and the effect could~     persist for 1-3 months in different studies. However most sutdies lack the sham or control~     group. The purpose of this study was to assess the effect of shock wave for spasticity in~     wrist and hand.~   "
63782|NCT02222428|"~     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and~     CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following~     inhalation of the fixed dose combination (FDC) of 6.2 μg BI 1744 CL plus 727.3 μg BI 54903~     XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following~     inhalation of the mono compounds of 10 μg BI 1744 CL (as aqueous solution for inhalation,~     AIS) and 727.3 μg BI 54903 XX (EIS), respectively, when administered once-daily via~     Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy~     volunteers. Secondary objectives were to compare exposure to BI 1744 BS and CD 1857 XX after~     a single dose of the BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds,~     respectively; to compare exposure to BI 54903 XX after a single dose and at steady state~     after multiple doses of the BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono~     compounds, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903~     XX when administered as BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and as the mono~     compounds, respectively.~   "
63783|NCT02222415|"~     Resistance type exercise training has been shown to be a potent stimulus to increase~     skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also~     known to affect the muscle adaptive response following exercise. Whether timed protein~     intake could augment the increase in muscle fiber size and/or satellite cell content~     following long-term exercise intervention remains to be established.~      We hypothesize that protein supplementation before sleep, on both training and non-training~     days, during a 12 week resistance training program further increases type II muscle fibre~     cross sectional area when compared to the placebo group.~   "
63784|NCT02222402|"~     The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise~     training intervention designed to improve quality of life (QOL) and alleviate functional~     limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.~     Exercise rehabilitation will be compared against established treatment options available~     within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the~     experience and acceptability of the intervention for both participants and members of the~     renal care team. In addition, we want to examine whether this type of additional exercise~     treatment is cost effective within the health service setting.~      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380~     adult patients who have been on HD for at least 3 months, from 10 HD sites located in~     Scotland, England and Wales. The type of exercise programming will consist of cycling~     exercise performed during each dialysis session plus a muscle conditioning programme~     performed twice per week. All exercise sessions will be supervised by a physiotherapy~     assistant. The exercise prescription will be individualised for all patients on the basis of~     their fitness and clinical status.~      The main objective is to examine the impact of exercise rehabilitation on quality of life~     and well being of patients. We hypothesise that the exercise training delivered during~     haemodialysis treatment will significantly improve the functional limitations/abilities of~     the patients leading to the detection of clinically beneficial improvement in quality of~     life outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end~     point.~   "
63785|NCT02222389|"~     Contingency management (CM) is a type of treatment used in the substance abuse field.~     Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to~     treatment, contingency management emerged from the behavior therapy traditions in mental~     health. By most evaluations, contingency management procedures produce one of the largest~     effect sizes out of all mental health and educational interventions.~      The purpose of this study is to perform a randomized, controlled trial to evaluate the~     ability of a culturally-tailored contingency management (CM) intervention to increase~     alcohol and drug abstinence among American Indian (AI) tribal members from two rural~     reservations in the Northwest.~   "
63786|NCT02222376|"~     Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of~     various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and~     vascular endothelial growth factor, among others) that possesses anti-inflammatory and~     anti-fibrinolytic properties.~      The aim of this study is to compare the effect of topic treatment with pirfenidone compared~     to conventional treatment in chronic diabetic foot ulcers.~      The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers~     (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to~     conventional treatment. This is a randomized, controlled and crossover study. Patients will~     be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the~     end of this period they will change groups. Each week ulcers will be for size, depth, length~     and evidence of infection. The ulcers will have proper debridement in the conventional~     treatment group and debridement plus topical pirfenidone application in the pirfenidone~     group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical~     pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a~     day.~   "
63787|NCT02222363|"~     The purpose of this study is to evaluate the safety and tolerability of the investigational~     drug VLX600 in patients with refractory advanced solid tumors.~   "
63788|NCT02222350|"~     The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with~     placebo in Japanese patients with Type 2 Diabetes Mellitus.~   "
63798|NCT02222220|"~     Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable~     adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no~     effective enough treatment for this side effect.~      Previous studies demonstrated that different medications from the substitute benzamide~     derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine~     receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the~     deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of~     clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide~     derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in~     general medicine). The investigators hypothesis assumes that anti-salivation effect~     characterizes the whole group of benzamide.~      The aim of this study was to examine the efficacy of metoclopramide as an optional~     possibility for management of CIH.~   "
64948|NCT02207205|"~     1. Determine if there is any difference between the whole blood clotting time results~          obtained from blood drawn from indwelling catheters and direct venipuncture~        2. Determine the intra-subject variability in both procedures~   "
63789|NCT02222337|"~     Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors.~     Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends~     and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast~     cancer. Through strong community-academic partnerships, the investigators seek to improve~     the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In~     this project, the investigators plan to further develop and refine the intervention and then~     test it through a randomized controlled trial. First, the investigators will conduct~     in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the~     intervention fits for survivors and caregivers in different parts of the country. Then, the~     investigators will revise the intervention. Finally, the investigators will test the~     intervention in a randomized controlled trial. The investigators will invite 125~     survivor-caregiver dyads to be a part of our study. Half will be asked to complete the~     intervention and half will be offered the usual services, such as support groups. The~     information learned from this study could help improve the quality of life in Latina breast~     cancer survivors and their caregivers. Physicians, survivors, and community groups can also~     benefit from this study because they will have more information about the needs of Latina~     breast cancer survivors. The investigators hope to use the information to help other types~     of survivors and caregivers in the future.~   "
63790|NCT02222324|"~     This thorough QT (TQT) study will take place in healthy subjects administered single doses~     of study drug. It will be a randomized, double-blind, placebo and active-controlled,~     4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12~     possible treatment sequences. Each treatment sequence will comprise all 4 treatments.~   "
63791|NCT02222311|"~     The investigators wish to study the effect of Vitamin D on the development of autism in~     children. The investigators will also investigate the environmental and genetic influences~     on the level of Vitamin D in children with autism.~   "
63792|NCT02222298|"~     Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive~     treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have~     designed a comparative study between the conventional and the minimally invasive treatment.~     Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision~     with a Bascom out-midline closure (Control group).~   "
63793|NCT02222285|"~     The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related~     symptoms in children.~   "
63794|NCT02222272|"~     Stem cell transplantation will continue to be a treatment option for patients with chronic~     myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many~     patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the~     time of allogeneic stem cell transplantation.~      While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact~     on the outcome of allogeneic stem cell transplantation little is known on the impact of~     prior use of second generation TK inhibitors.~      Therefore this non interventional prospective study addresses this question and patients~     undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will~     be followed by the data office office on engraftment, treatment related mortality, relapse~     rate and survival, prospectively. Details on TKI therapy will be collected by the~     participating centers, retrospectively.~      This is a non interventional prospective study. There is no upper limit to the number of~     patients entered, but it is estimated that up to 450 patients will be included in 150~     centres for this non interventional prospective study. The registry will include patients~     for three years plus one more year for follow up and data analysis which should then be~     followed-up until the projected end of the non interventional prospective study.~   "
63795|NCT02222259|"~     The purpose of this study is to determine the feasibility of implementing a randomized~     controlled study of the intervention (Geriatric Assessment followed by an integrated care~     plan carried out by the multidisciplinary geriatric oncology team) designed to~     maintain/improve quality of life and functional status in older adults with advanced~     gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.~      Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer~     treatment decision of the cancer specialist.~   "
63796|NCT02222246|"~     The goal of this pilot study is to improve emergency department (ED) pain management for~     adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic~     disorder in the United States, and occurs primarily among African Americans. Management of~     painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the~     most common reason for SCD patients to visit the ED. Currently, there is no standard~     approach to managing VOC pain in the ED that is widely accepted and used, and pain~     management for vaso-occlusive crisis in persons with SCD is very different between providers~     and not based on research. Many times, patients who come to the ED with sickle cell pain~     feel that they do not receive adequate pain control. If EDs could provide efficient,~     effective, safe, patient-centered analgesic management, it may be possible to improve pain~     management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive~     crises caused by sickle cell disease will soon be published by the National Heart, Lung and~     Blood Institute of the National Institutes of Health. These guidelines recommend~     patient-specific pain treatment protocols or a standardized pain management protocol for SCD~     when a patient does not already have a pain treatment protocol designed for them. The~     purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the~     ED for adults with sickle cell disease, and to determine if a large randomized controlled~     trial is feasible and required.~   "
63797|NCT02222233|"~     To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)~     administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as~     solution to the jejunum, ascending or descending colon, or as particulate to the ascending~     colon~   "
63814|NCT02222012|"~     The investigators propose a multi-source pattern which integrates neuroimaging data~     associated with multiple, symptom-related neural processes relevant in depression to improve~     classification accuracy. The investigators conclude that combining brain activation related~     to the core-symptoms of depression using the multi-source monitoring data substantially~     increases classification accuracy while providing a sparse relational neuromarkers-model for~     future prediction.~   "
63799|NCT02222207|"~     Part A (Phase IIa):~      Primary objectives:~      The study part A is designed to investigate whether the use of regorafenib eye drops can~     help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better~     after 4 weeks and 12 weeks after inclusion into this study.~      Secondary objectives:~      The study will also evaluate the safety and tolerability of the regorafenib eye drops.~      Part B (Phase IIb):~      Primary objectives:~      The study part B is designed to investigate:~        -  how often the regorafenib eye drops need to be given per day~        -  whether the use of regorafenib eye drops can help patients with neovascular (wet)~          Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after~          inclusion into this study.~      Secondary objectives:~      The study will also evaluate how the different dosings of regorafenib eye drops affect~     patients vision, the safety and the tolerability.~   "
63800|NCT02222194|"~     In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal~     staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than~     50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of~     mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to~     perform a prospective multicentric observational study to measure the sensitivity of~     mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable~     (suspected) NSCLC patients.~   "
63801|NCT02222181|"~     In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even~     having access to, little is known about the effectiveness, safety and adherence of drug~     therapy in this group of patients. The research aims to promote adherence and develop~     strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference~     centre for the Elderly of Araraquara. The clinical parameters will be assessed at the~     beginning and after the educational intervention period from April 2014 to April 2015.~   "
63802|NCT02222168|"~     To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the~     pharmacokinetics of BI 409306 when given at bed time.~   "
63803|NCT02222155|"~     The aim of this trial is to test the safety and efficacy of two dose regimens of the~     complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody~     (ANCA)-associated vasculitis (AAV).~      Funding Source - FDA OOPD~   "
63804|NCT02222142|"~     Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to~     intermittent regional ischemic episode. The investigators retrospectively evaluated the~     cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients~     undergoing OPCAB.~   "
63805|NCT02222129|"~     A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local~     injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic~     urologic surgeries in an effort to determine which method reduced postoperative opioid use~     the most.~   "
63806|NCT02222116|"~     The objective is to demonstrate that the Flow Area within a blocked coronary vessel as~     assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent~     (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study~     hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with~     stenting with a non-mesh DES or BMS.~   "
63807|NCT02222103|"~     The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm~     Diagnostic Systems, Inc. which has many sensors inside in a Band-Aid like strip in order~     to see if it can help diagnose capabilities in individuals suspected of having obstructive~     sleep apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable,~     battery-powered, flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and~     records a number of physiological health related parameters such as ECG, heart rate, pulse~     synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and~     motion/position. One advantage of this device over current home diagnostic systems is the~     capability for recording over several nights.~      The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to~     gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring~     will explore potential findings supportive of sleep apnea while monitoring at home during~     routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically~     indicated sleep study will help us to make these determinations. Subjects will wear the~     device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10~     days. Subjects will go about their normal daily activities and return the device via mail~     once completed.~   "
63808|NCT02222090|"~     The aim of the present registry is to characterize and follow patients prospectively and~     retrospectively with renal impairment who have been prescribed apixaban for the prevention~     of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes~     associated with warfarin therapy in this population.~   "
63809|NCT02222077|"~     This study aims to investigate in adolescents and young adults:~        -  the 24h diurnal variation of ambulatory central blood pressure~        -  the association of central compared to peripheral blood pressure with indices of~          asymptomatic target-organ damage~   "
63810|NCT02222064|"~     Research questions/hypotheses~        1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients~          reduce pain-related distress, improve quality of life, and increase confidence in pain~          self-management?~        2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness~          methods?~   "
63811|NCT02222051|"~     In this study the efficacy of Tai Chi will be tested in comparison to conventional neck~     exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will~     be lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks~     of training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of~     life, wellbeing, stress perception, psychological distress will be used to determine~     effects.~   "
63812|NCT02222038|"~     The purpose of this study is to investigate the genetic architecture of Linear Localized~     Scleroderma (LLS) (linear morphea) by whole exome sequencing.~   "
63813|NCT02222025|"~     Playing football can induce considerable beneficial health effects, but is also a~     high-intensity and high-impact sport with many situations of direct contact between players~     which bear the risk of injury. Thus, it is necessary to implement preventive measures to~     reduce the risk of injury and support the health benefits.~      Injury characteristics of players older than 13 years are similar to adult players and,~     thus, similar preventive measures are beneficial. Younger players seem to show partly~     different injury characteristics. Consequently, preventive programmes proven effective in~     late adolescent or adult players need to be adapted for younger age groups. To date, no~     study investigated the prevention of football injuries in children under the age of 13~     years.~      We aim to assess the effectiveness of an exercise-based prevention program to reduce~     football-related injuries in children younger than 13 years.~      The primary outcome in this study is the overall injury rate. Secondary outcomes are the~     rate of severe injuries and acute injuries.~      The study is designed as a two-armed cluster-randomized controlled trial. We will recruit 9~     to 12 years old children (boys and girls, born 2002 to 2005) participating in regular~     training and match play in an officially registered football club in Switzerland (further~     study centres are located in the Netherlands, Germany and the Czech Republic). The chosen~     age group is usually subdivided into two age categories (9/10 years, 11/12 years).~      Recruitment will take place via the national and regional football associations.~      Inclusion criteria are: the clubs must be officially registered in the regional football~     association, children must be between 9 and 12 years old at the start of the study and~     regular training must take place at least twice per week. Teams will be excluded, if the~     coaches already perform a structured warm-up focusing on neuromuscular control or an~     existing injury prevention programme.~      Injury surveillance will include a baseline questionnaire, players´ exposure and injury~     registration. Anthropometric baseline data and information regarding previous~     football-related injuries will be obtained prior to the start of the study from the parents.~     Injury and exposure surveillance will be assisted by an automated internet-based injury~     recording system which has been developed and applied during our own epidemiological~     project.~      For all participating teams, one contact person will be appointed. Those persons will be~     provided with exact instructions on injury definitions as well as examples how to complete~     the injury and exposure forms within the online injury recording system.~      If an injury occurred, one trained person will contact the coach as well as the player and~     the parents by telephone and/or e-mail to assess all relevant aspects of the injury based on~     a standardized injury registration form. In case of injuries which require medical treatment~     parents will be supported to receive the exact diagnosis from the attending physician~     (either as specific written diagnosis or by use of a specific injury coding system). Two~     blinded investigators will additionally assess all information with regard to each injury to~     allow for objective and independent injury surveillance.~      20 study assistants and 4 scientific assistants will support coaches with data collection~     and injury recording. Each study assistant will be responsible for eight clubs. Study~     assistant will regularly keep in touch with the clubs and will visit two training sessions~     of each team during the study period.~      The intervention period will last one complete season. The injury prevention program will be~     included at the beginning of the usual football training by replacing the traditional~     warm-up. The programme will be conducted at least two times a week by the intervention~     teams. The prevention programme contains seven exercises and lasts about 10 to 15 min after~     familiarisation. Three exercises focus on unilateral, dynamic stability of the lower~     extremities (hopping, jumping and landing). Further, three exercises emphasize whole body~     and trunk stability. The last exercise contains rolling movements to improve fall technique.~      The coaches of the control group will receive the instruction to regularly perform a common~     warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and~     stability exercises).~      The yearly incidence injured players in children is 8.6%. A risk reduction of one third has~     been recently acknowledged as a relevant effect size for injury rate. This corresponds to a~     reduction of the yearly incidence to 5.8% injured players. In order to achieve a statistical~     power of 80% and taking an allocation ratio of 1:1 and a cluster-inflation factor of 1.7~     into account, in total 4´000 players are needed for statistical analysis. Assuming a~     realistic drop-out rate of about 33%, 6´000 children will be initially recruited.~   "
63815|NCT02221999|"~     The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based~     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast~     cancer.~      In patients with hormonal receptor positive advanced breast cancer, neo-adjuvant~     chemotherapy combined with hormonal therapy may improve the pathological remission rate.~   "
63826|NCT02221856|"~     Technological advances have made computer aided orthodontic treatment planning possible. 3D~     dental scanners and software make it possible to design and approve the outcome before~     treatment begins. Manufacturers have provided different customized appliance systems that~     would help practitioners achieve those computer-designed outcomes. The purpose of this study~     is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at~     achieving the predicted alignment and comparing that to the accuracy of conventional~     orthodontic bracket placement at achieving a predetermined goal. The results of this study~     will help orthodontists and patients know if there is an advantage to using custom~     appliances. The study will be a prospective clinical study and will include a total of 60~     arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will~     be assigned to each of the two study groups (Motion View or control). Both groups will have~     a 3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated~     design that the orthodontist believes is the optimized outcome. At the end of each patient's~     participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and~     alignment using ABO's objective grading system's criteria for alignment, marginal ridges and~     buccolingual inclination. Each arch will then be superimposed on the predicted outcome to~     determine how accurate each system was at achieving the planned movements in all 3~     dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion~     View) at achieving the predicted outcomes will differ in comparison to the accuracy of~     conventional orthodontic bracket placement at achieving a predetermined goal.~   "
63827|NCT02221843|"~     Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose~     of this study is to track sun behavior of patients at high risk for skin cancer, to~     investigate the feasibility of this prototype in daily life and to investigate the technical~     accuracy of the Sunbit.~   "
63828|NCT02221830|"~     Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in~     patients with pre-eclampsia (PE)~   "
63829|NCT02221817|"~     Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with~     trochanteric bursitis experience chronic intermittent or continuous hip pain at and around~     the greater trochanter.~      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,~     though this has not been confirmed. Accordingly, the use of corticosteroid injections has~     been shown to provide considerable relief. However, routine blind injections, those~     performed without the aid of imaging, such as fluoroscopy, have shown limited success in the~     appropriate needle placement. Fortunately, blind injections have yielded positive results in~     majority of the cases. Additionally, the use of fluoroscopy has not shown to improve~     clinical outcome for trochanter bursa injections.~      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such~     as ultrasound have not been studied and may be more useful. Fluoroscopy allows for~     bony-landmark based injections. Ultrasound allows for direct visualization of the soft~     tissue structures such as the bursa and has gained significant support for use in~     musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the~     benefit of an ultrasound guided injection and whether ultrasound should be routinely used~     during trochanter bursa injections.~   "
63830|NCT02221804|"~     Chronic Obstructive Pulmonary Disease (COPD) is the most common pulmonary disease,~     responsible for considerable morbidity and mortality and is the third leading cause of death~     worldwide. As well as its consequences in the lungs, COPD is well recognized to be~     associated with a range of important systemic consequences and co-morbidities.~     Interestingly, skeletal muscle dysfunction is noted in both early and advanced disease,~     suggesting its origins may not be wholly pulmonary.~      Treatment strategies targeting lung function are, unfortunately, of limited value. Given the~     burden of disease, it is becoming increasingly important that investigative and therapeutic~     work now focuses on other systemic characteristics and sequelae which define the disease~     phenotype.~      This is a randomized controlled trial of the effect of 14 days of voluntary reduced activity~     on muscle mass, muscle strength, body composition, and atrophy signalling in patients with~     COPD and age-matched controls.~      The primary hypothesis upon which this study is based is that a short reduction in~     ambulation will induce a transient reduction in quadriceps muscle mass, quadriceps strength~     and physical performance in patients with COPD compared to matched COPD patients whose~     mobility has not been restricted.~      The secondary hypothesis is that the magnitude of the above changes will be greater in~     physically inactive COPD patients compared to physically inactive age-matched controls.~      The overall aim of this research is to use an in vivo human model of 14 days of voluntary~     reduced physical activity to test the above hypotheses. If the model proves feasible, this~     will allow for earlier proof of concept studies of novel therapeutic agents.~   "
63831|NCT02221791|"~     Intervention studies support a protective effect of flavonoid-rich foods such as chocolate~     and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin~     improves markers of vascular function and insulin resistance although the results were less~     pronounced than the majority of chocolate intervention studies.~      The food matrix of chocolate or other compounds present in chocolate could play a role in~     the bioavailability of flavonoids, resulting in these heightened improvements in vascular~     function.~      In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid~     chocolate on markers of vascular function.~   "
63832|NCT02221778|"~     This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed~     Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation~     Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our~     population of patients.~   "
63843|NCT02221635|"~     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic~     stimulation in the prevention of relapse of the symptoms of schizoaffective disorder.~     Primary Outcome Measures:Time between subject randomization to treatment and the first~     occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures:~     Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and~     PANSS factor scores; Illness severity change as measured by Clinical Global Impression of~     Severity for depression (CGI-S-DEP); Change in subject functioning using the Personal and~     Social Performance Scale; Change in subject medication satisfaction using the Medication~     Satisfaction Questionnaire (MSQ).~   "
63833|NCT02221765|"~     Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by~     increasing cardiovascular disease, diabetes and cancer. Current treatments for obesity have~     either poor efficacy or significant side effects. Pancreatic polypeptide (PP) is a promising~     new drug target as it produces powerful appetite suppression which, following a 90-minute~     infusion continues to act for 24 h in man. We have developed a new long lasting high potency~     analogue of PP, PP1420. This is delivered as a once-a-day subcutaneous injection via a~     painless fine-gauge needle.~      In a first-time-in-man Phase 1a trial, that PP 1420 proved safe, well tolerated, and had~     extended pharmacokinetics compared to PP itself.~      We now plan to study the safety and PK of PP1420 up to 64mg. We will also assess:~        1. Its efficacy in reducing food intake after a single dose in a Phase 1B study in healthy~          volunteers.~        2. Its efficacy in reducing food intake and weight after multiple dosing in a Phase 1C~          study in healthy volunteers.~   "
63834|NCT02221752|"~     According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant~     women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at~     the same time showed that the prevalence of IDA among pregnant and lactating mothers was~     46.39% and 47.21% respectively. There was a significant difference between urban and rural~     areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF~     recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we~     don't know much about their influence on maternal and infant health and their clinical~     effectiveness. Health Department of China recommends taking 400ug folic acid before~     pregnancy and during early pregnancy. But for various reasons, not all expecting mothers~     take this advice. Besides, we don't have a national level technical standard of how to take~     nutrition supplements during pregnancy. Therefore, it's crucial for us to study if~     iron/folic acid or folic acid only can prevent perinatal complications, as well as their~     influences on infant and toddler health.~      The purpose of this study is to test whether taking iron/folic acid and folic acid only from~     early pregnancy until delivery will lower the chances of pregnancy complications, and to see~     how supplements affect gestation results. As well, it will evaluate a) whether taking iron~     supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron~     supplement can increase mother and fetus iron storage; and c) how mother's iron level~     affects newborn's iron level. We hope to understand nutrition conditions during pregnancy~     and investigate the relations between pregnancy diet and complications during pregnancy,~     weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of~     taking iron and folic acid during pregnancy on the health of infants and toddlers.~   "
63835|NCT02221739|"~     The purpose of this study is to investigate how effective and how safe the combination of~     radiation therapy and an investigational medication targeting the immune system known as~     Ipilimumab in the treatment of metastatic non-small cell lung cancer (NSCLC).~      The investigators would like to see if this combination of radiation and Ipilimumab can~     stimulate the body's immune system to stop the growth of tumors that are outside the field~     of radiation. The investigators would like see if using this combination of radiation~     therapy with Ipilimumab could help the body reject the patient's own tumor or at least help~     their immune system to maintain the disease stable and/or slow its growth.~      Radiation therapy (RT) is currently a standard procedure for treatment of NSCLC. Ipilimumab~     is considered an investigational medication because it is not approved by the Food and Drug~     Administration (FDA) for the treatment of NSCLC. Ipilimumab has been approved by the FDA for~     the treatment of metastatic melanoma.~   "
63836|NCT02221726|"~     The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive~     quality of placebo (an inactive substance that is compared with a drug to test whether the~     drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the~     skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch~     sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).~   "
63837|NCT02221713|"~     Colonic diverticula are outpouchings of the large bowel, and they occur in up to 60% of~     people over 60 years of age. About 10-25% of patients with diverticula will have symptoms.~     These can range from acute diverticulitis, which can be a lethal infection to symptomatic~     diverticular disease, which involves inflammation of the bowel and altered bowel habits,~     decreasing patients' quality of life. We do not know which patients will develop acute~     diverticulitis or which patients will develop diverticula in their colon.~      We believe that diverticulitis may be associated with, or even caused by, alterations in the~     bacteria that live in the colon, known as the gut microbiome. Until recently it was too~     expensive and too complex to examine the microbiome in detail. We propose to examine for the~     first time in detail the microbiome of patients with acute diverticulitis and asymptomatic~     diverticulosis.~      Stool samples will be analysed for gut microbiome composition by 16S ribosomal RNA gene~     pyrosequencing. There is a part of the bacterial cell, the ribosome, which is the same in~     all bacteria (16S). Through PCR, polymerase chain reaction, and sequencing, we can separate~     out the different types of bacteria in a sample. We can then look at the different kinds of~     bacteria in each patient population, as well as how diverse the populations are within the~     groups, and compared to other groups.~      We hope to be able to discriminate between the microbiome of patients with acute~     diverticulitis and asymptomatic diverticulosis. This study many change how diverticulitis~     and diverticulosis are conceptualized and treated. Alterations in the microbiome in these~     disease states may be able to be treated, preventing further disease.~   "
63838|NCT02221700|"~     The goal of this research study is to compare the level of effectiveness of two massage~     treatment schedules for chronic CIPN in people treated with Oxaliplatin or taxanes~     (docetaxel, paclitaxel) for their cancer (breast and gastrointestinal) . Researchers also~     want to study how participants may respond to massage treatments, and how the treatments may~     affect quality of life and physical performance.~   "
63839|NCT02221687|"~     The primary objective of this study is to demonstrate that a synbiotic formula, fed for the~     duration of the first year of life (infant and follow-on formula) reduces the incidence rate~     of episodes of infectious diarrhea in infants during the first year of life compared to a~     standard infant formula.~   "
63840|NCT02221674|"~     This is a multicenter, open-label (all people involved know the identity of the~     intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are~     absorbed in the body, how are they distributed within the body and how are they removed from~     the body over time) in children aged from birth to less than 2 years after a scheduled~     surgical procedure that routinely produces moderate to severe acute post-surgical pain.~      The trial will also evaluate the safety and tolerability of tapentadol oral solution in the~     population studied and the effect of tapentadol oral solution on pain.~   "
63841|NCT02221661|"~     The purpose of this study is to assess the performance of AclarusDx™, an investigational~     blood test detecting gene expression information, and intended to help physicians in making~     an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive~     impairments.~   "
63847|NCT02221583|"~     The purpose of this study is to evaluate how quickly and to what extent different~     immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal~     transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune~     system is the body's defense against diseases. It also attacks foreign tissues such as a~     transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL),~     Prograf, and mycophenolate mofetil may be given to suppress the immune system following~     kidney transplantation and prevent rejection of a transplanted kidney. This study is being~     performed to determine if patients who undergo laparoscopic sleeve gastrectomy need~     different doses of immunosuppressant medications.~   "
63848|NCT02221570|"~     Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism~     of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are~     associated with significantly diminished quality of life.~      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps~     in patients with liver cirrhosis.~   "
63849|NCT02221557|"~     A case series to compare the handling and effectiveness of two different treatment~     approaches using a new alloplastic bone graft material in ridge preservation compared to~     allograft existing historical data.~   "
63850|NCT02221544|"~     This study is a double blind comparative study examining the effectiveness of the rTMS~     treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We~     hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait~     quality and decrease the frequency of FOG in patients with Parkinson's disease.~   "
63851|NCT02221531|"~     Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml~     after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood~     transfusion within 24 hours after delivery (World Health Organization, Recommendations for~     the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).~     Since PPH is more common after caesarean deliveries than after vaginal births and the rate~     of CS is rising over time and will probably continue to rise, the incidence of PPH is~     expected to increase accordingly.~      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean~     delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al.,~     Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative~     delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the~     advantage over oxytocin of having a longer half-life and therefore reducing the use of~     additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a~     short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J~     Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin~     minimises the cardiovascular side effects without compromising the uterine tone. Therefore,~     we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid~     compared to a bolus application in women undergoing primary or secondary caesarean delivery.~     This prospective, double-blind, randomised controlled non-inferiority trial will take place~     at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be~     inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a~     short-infusion than after a bolus administration (primary safety endpoint).~   "
63852|NCT02221518|"~     The purpose of this study is to examine the brain functioning of OCD patients and healthy~     controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.~   "
63853|NCT02221505|"~     LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ~     antibody conjugated to a maytansine payload via a non-cleavable linker.~      LOP628 provides an opportunity to target cKit overexpressing tumors.~   "
63854|NCT02221492|"~     Primary Objective:~      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte~     colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a~     target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in~     4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.~      Secondary Objectives:~        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL~          participants.~        -  To compare the 2 treatment arms with respect to the number of participants who achieved~          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.~        -  To compare the 2 treatment arms with respect to the number of days of apheresis~          required to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.~   "
63855|NCT02221479|"~     Primary Objective:~      To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating~     factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of~     greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer~     days of apheresis than MM patients mobilized with G-CSF alone.~      Secondary Objectives:~        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM~          patients.~        -  To compare the 2 treatment arms with respect to the number of participants who achieved~          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.~        -  To compare the 2 treatment arms with respect to the number of days of apheresis~          required to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.~   "
63856|NCT02221466|"~     The purpose of this clinical study is to test whether or not patients treated with HBOT for~     diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during~     the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index~     (RHI) measured by the peripheral arterial tonometry (PAT).~   "
63857|NCT02221453|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This~     condition can develop in diabetics where swelling results from leaking of fluid from the~     blood vessels of the eye, into the center of the retina, the macula. If left untreated, this~     can affect central vision. The current standard treatment for diabetic macular edema~     includes medications injected directly into the eye (intravitreal injections) and laser eye~     treatment. The drugs that are injected directly into the eye are known as anti-Vascular~     Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes~     bevacizumab (Avastin®) and ranibizumab (Lucentis®).~      However, some patients do not respond well to these anti-VEGF treatments will be given the~     option of switching to an another class of medications, called steroids. Triamcinolone~     acetonide is one of these steroids and is also injected directly into the eye. These~     steroids will help reduce inflammation and possibly as a consequence, reduce swelling in the~     eye.~      The purpose of this study is to determine what cellular factors affect a patient's treatment~     response (amount of swelling reduction) following triamcinolone acetonide intravitreal~     injections for diabetic macular edema.~   "
63858|NCT02221440|"~     Supplementary oxygen is routinely administered to patients, even those with adequate oxygen~     saturations, in the belief that it increases oxygen delivery. However, oxygen delivery~     depends not just on arterial oxygen content but also on perfusion.~      Maternal oxygen administration has been used in an attempt to lessen fetal distress by~     increasing the available oxygen from the mother. However, the effect of supplemental~     maternal oxygen therapy on fetal acid base status has been debated for more than seven~     decades.~      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second~     stage of labor can relieve fetal distress.~   "
63859|NCT02221427|"~     The purpose of this study is to evaluate if the rate of emergency caesarean section can be~     reduced if adhering to a dynamic labour progression curve compared to a static progression~     curve for first time mothers without jeopardising maternal and neonatal outcomes~   "
63860|NCT02221414|"~     Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose~     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500~     mg administered together~   "
63861|NCT02221401|"~     Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose~     combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin~     1000 mg administered together.~   "
63862|NCT02221388|"~     To compare the oral bioavailability and rate of absorption of two different formulations of~     BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without~     EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA~     formulations were further investigated concerning food effect and one of the two BI 671800~     HEA formulations identified by interim pharmacokinetic analysis was further investigated~     concerning dose proportionality with 50 mg.~   "
63863|NCT02221375|"~     The objective of the study was to investigate safety, tolerability and pharmacokinetics of~     butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler~     B (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of~     BI 54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure~     of single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose~     Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).~   "
63864|NCT02221362|"~     Study 701-901, a multicenter, multinational, longitudinal, non-interventional observational~     study in subjects, at least 18 years old, diagnosed with late-onset Pompe disease~     prospectively collects data to understand clinical progression in terms of respiratory~     function, symptomology, genotype, biochemistry, endurance and selected subject-reported~     measures for 24 weeks followed by a 240 week additional observation period for up to 100~     subjects.~   "
63865|NCT02221349|"~     This study will compare the safety and effectiveness of normal oral hygiene with two~     different marketed dentifrices, on longer term dentinal hypersensitivity response following~     use of potassium oxalate desensitizers.~   "
63866|NCT02221336|"~     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many~     patients do not recover to their previous psychosocial function. Major reasons for poor~     outcomes are delayed intervention for prodromal depressive and manic symptoms as well as~     decreased adherence with treatment.~      Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a~     smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled~     trial, to test the effect of daily reporting of subjective self-monitoring of depressive and~     manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.~      In the MONARCA II trial the investigators will develop and deploy a new version of the~     smartphone based monitoring system. The investigators will in a randomized controlled single~     blind trial investigate whether daily electronic monitoring of subjective and objective~     measures of illness activity using a smartphone based self-monitoring system including~     feedback on subjective as well as automatically generated objective data (e.g.social~     activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive~     and manic symptoms and improves functioning more than a control group receiving a~     smartphone. All patients will be followed for 9 months with outcome assessments at baseline,~     after 4 weeks, after 3 months, after 6 months and after 9 months.~   "
63867|NCT02221323|"~     The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin~     lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both~     state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of~     insulin efficacy after injection into these different areas is still unclear. The results~     from this study may expand the knowledge on the severity of this issue and may provide~     evidence for future treatment recommendations regarding injection sites for insulin~     administration.~   "
63868|NCT02221310|"~     Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with~     chemotherapy followed by allogeneic stem cell transplantation will be given to patients with~     high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).~   "
63869|NCT02221297|"~     Purpose of the study is to determine the effect of the investigational products as consumed~     with a meal on serum lipids, primarily on LDL cholesterol.~   "
63870|NCT02221284|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of~     alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate~     response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin~     secretagogues)* in addition to dietary/exercise therapy in daily medical practice.~      * Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors,~     thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use~     surveys for Nesina Tablets.~   "
63871|NCT02221271|"~     Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic~     criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not~     conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin)~     400mg/kg/day for five consecutive days.~      Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by the start of the study treatment.~   "
63872|NCT02221258|"~     The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to~     severe rheumatoid arthritis after infusion.~   "
63873|NCT02221245|"~     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out~     normal cells, causing morbidity and ultimately mortality. the cancer stem cell theory~     suggests that most tumors undergo a process of differentiation through which a relatively~     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of~     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result~     of this cellular diversity, one or more cells within the tumor are likely to be resistant to~     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key~     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the~     original intervention. The cellular programs driving the uncontrolled proliferation of many~     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in~     esc. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs~     will be effective in the treatment of cancer. The investigator's research program focuses on~     the elucidation of signaling mechanisms, control of cellular processes and discovery of~     small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are~     fundamental to CSCs. Our preliminary results identified a novel Notch associated protein~     NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed~     in human solid tumors and is required for cell survival and tumor growth in notch -dependent~     tumor cells.~      The investigator's aim is to further interrogate the link between Notch and Nack.~      Specific Aims:~        -  Identify and isolate the cancer stem cell populations from primary chemo naive~          esophageal tumor samples.~        -  Interrogate the status of the Notch,( the link between Notch and Nack), Wnt and Hedghog~          pathways in the chemo naive esophageal tumor as well as in specific cell populations,~          such as the CSC.~        -  Determine the degree of cross-talk between these pathways and which of these pathways~          is essential for the self renewal properties and tumorigenic properties of the esc~          population.~        -  Identify critical targets for therapeutic intervention in CSC populations.~   "
63874|NCT02221232|"~     The purpose of this pilot study is to evaluate antimicrobial properties of a single test~     product, a vehicle product and a reference product applied in two different areas when used~     as a patient preoperative skin preparation.~   "
63875|NCT02221219|"~     Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions~     that commonly occur in preterm infants and are well-recognized major contributors to~     long-term brain injury and related disabilities later in life. Despite its prevalence, long~     term consequences, and enormous medical and social costs, mechanisms of IVH and optimal~     strategies to prevent or treat its occurrence are poorly defined, especially for extremely~     premature infants. Only one medical therapy, prophylactic indomethacin during the first 3~     days of life, has been shown to prevent or decrease the severity of IVH in preterm infants,~     but its use is limited by toxic side effects and debatable effects on long-term outcomes.~     Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC)~     may also decrease the incidence of IVH in premature infants, but thus far these trials have~     indomethacin treatment mixed within their cord clamping protocols. The investigators are~     conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no~     intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of~     DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity,~     neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in~     extreme prematurity births and clear links of IVH to long-term disabilities there is a need~     to improve care for these patients. This multi- disciplinary project addresses an important~     medical problem for an understudied patient population, where the current practice has clear~     limitations.~   "
63876|NCT02221206|"~     The intended study is designed as a prospective randomized controlled trial (RCT), comparing~     and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum~     anchorage by retracting the maxillary incisors.~   "
63877|NCT02221193|"~     Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can~     improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by~     targeting specifically oral malodor implicate anaerobic bacteria.~      Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive~     correlational crossover cross-section clinical trial conduct during the month of Ramadan in~     the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia~     involving the application of Listerine® Cool Mint® mouth rinse by either the traditional~     panoral rinsing method or a site-specific disinfection method targeting the subgingival and~     supragingival plaque and the posterior third of the tongue dorsum while avoiding the~     remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial~     counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and~     the tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.~   "
63878|NCT02221180|"~     The purpose of this study is to evaluate the bioequivalence of metformin component of the~     canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet~     compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and~     fasted participants.~   "
63879|NCT02221167|"~     This study is a randomized controlled trial seeking to determine whether supplementing~     infants at risk for excessive neonatal weight loss with a small volume of human donor milk~     prophylactically in the first 1-3 days of life, before maternal mature milk production~     (before mom's milk comes in) will decrease the incidence of formula use at 1 week and 1,~     2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk~     population.~      We hypothesize that supplementation of term infants who have lost greater than or equal to~     5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds,~     until mature milk production, will result in decreased supplemental formula use at 1 week~     and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This~     study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive~     breastfeeding with offering early small-volume donor milk supplementation in a population of~     infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence~     of formula supplementation at 1 week of life and 2) improving breastfeeding duration.~   "
63880|NCT02221154|"~     The original mechanism of action of myo-inositol and preliminary results available in the~     literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce~     the risk of OHSS in PCOS patients.~      The aim of the study is to demonstrate that administration of myo-inositol decreases the~     incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS~     supported in IVF patients.~   "
63881|NCT02221141|"~     The purpose of this study is to determine the prevalence in Belgium of Fabry disease in~     patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to~     determine in Fabry patients which was the most frequently initial symptom.~      Actually the early diagnosis is important because a treatment exists that can prevent future~     complications.~   "
63882|NCT02221128|"~     A prospective, single centre, single arm study designed to collect clinical data on PerClot~     when used in subjects undergoing endoscopic sinus surgery.~   "
63883|NCT02221115|"~     Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential~     video/picture recording using the Google Glass device during their visit with the~     orthopaedic surgeon or resident.~      The investigators want to record the patient's level of acceptance and response to this new~     technology. There are two arms: Patients seen by a doctor wearing the Google Glass device~     and those that will not be exposed. Both groups will be asked to complete a survey after~     their clinic visit.~      The device users (doctor) will complete a survey which will evaluate how effective this new~     tool is in the Orthopaedic clinical setting.~   "
63884|NCT02221102|"~     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent~     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and~     slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral~     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying~     significantly less risk of intracranial hemorrhage.~      This trial is a randomized, double-blind, multicenter, controlled clinical trial in China.~     The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to~     aspirin alone for the treatment of high-risk patients with acute nondisabling~     cerebrovascular event.~   "
63885|NCT02221089|"~     Oxidative stress has been implicated to play a pathogenic role in many disease processes,~     especially in age-related disorders such as age-related macular degeneration. It has been~     hypothesized that antioxidative agents such as vitamins and minerals, which are capable of~     scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for~     patients with age-related disorders. Based on this hypothesis several different combinations~     of vitamins have been introduced, all targeting at reducing oxidative stress. However, the~     in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is~     hard to investigate. In the current study, we propose to investigate the effect of Retaron®,~     a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and~     trace elements, in a systemic in-vivo inflammation model.~      In the present study, the infusion of LPS, which is a cell wall component of gram-negative~     bacteria and a major mediator in the pathogenesis of septic shock, will be used as a~     standardized experimental model of systemic inflammation in humans. Given that inflammation~     is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS~     model is well suitable for determination of the antioxidative effects of Retaron®. As a main~     outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced~     by breathing 100% oxygen) will be tested in presence or absence of the antioxidant~     combination.~   "
63886|NCT02221076|"~     The protocol aims at demonstrating the technical feasibility and safety of doing~     endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and~     needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and~     surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all~     pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.~   "
63887|NCT02221063|"~     The purpose of this study is to determine whether consumption of thiamin fortified fish~     sauce over 6 months increases the thiamin status of women to a level consistent with a low~     risk of infantile beriberi. The investigators hypothesize that consumption of~     thiamin-fortified fish sauce will increase red blood cell thiamin concentrations, an~     indicator of thiamin status, in women consuming thiamin-fortified fish sauce, while~     concentrations will not change in women consuming a placebo fish sauce that does not contain~     thiamin.~   "
63888|NCT02221050|"~     A study conducted in the laboratory revealed the existence of a window during which~     patients with renal failure appreciate the protein-rich foods. This period, located~     immediately after the dialysis, is likely related to the purification of plasma products~     resulting from protein catabolism. It therefore appears necessary to understand the~     mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),~     leptin (anorectic hormone) and plasma amino acids.~   "
63889|NCT02221037|"~     Lung injury in patients undergoing oesophagectomy may occur during surgery~     (peri-operatively) as a result of One Lung Ventilation (OLV) and/or during the immediate~     post-operative period when patients receive intensive care. This is reinforced by the~     observation that physiological markers of lung injury are most elevated immediately after~     completion of surgery, and the development of clinical Acute Respiratory Distress Syndrome~     (ARDS)occurs immediately post-operatively (within 72 hours of surgery), with the majority of~     cases reported 24-48 hours after completion of surgery. This study is designed to~     investigate the impact of pre-operative administration of GSK2862277 on biological and~     physiological markers of lung injury in patients undergoing surgical resection of~     oesophageal cancer in order to achieve optimal exposure at the site of injury following OLV~     and lung deflation. This study is a randomized placebo controlled, double-blind,~     multi-centre, single dose parallel group, design. There will be two treatment groups~     comprising one active and one placebo arm with approximately 40 patients per group. Patients~     enrolled in the study will be scheduled to undergo planned/elective trans-thoracic surgery~     for oesophagectomy. The primary endpoint for this study is the change in pulmonary vascular~     permeability index (PVPI) from pre-surgical levels to the end of surgery. GSK2862277 will be~     administered as an orally inhaled aerosol (single nebulized dose) over approximately 3 to 5~     minutes (min) 1-3 hours prior to surgery. Subject will be monitored daily until discharge~     and followed up till day 28.~   "
63890|NCT02221024|"~     Children admitted in a ward often require a peripheral intravenous catheter to provide~     access for administration of medications, nutrients, fluids, blood products. Vascular access~     in children is a frequent and stressful procedure that should be performed as infrequently~     as possible in order to reduce the child's pain experience and the child's and family's~     level of distress. The maintenance of patency of indwelling catheters is therefore relevant~     to minimize need for replacement and children discomfort.~      Recent studies investigated the most effective and safe method of maintaining peripheral~     intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the~     use of heparin versus saline flushes, showing similar efficacy of the two approaches.~      To the best of the investigators knowledge no study addressed the issue of the optimal~     flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of~     normal saline flushes, at 12 and 24 hours intervals.~   "
63893|NCT02220985|"~     This phase II trial studies how well selective T cell depletion works in preventing~     graft-versus-host disease (GVHD) in patients with acute lymphocytic leukemia, acute myeloid~     leukemia, or chronic myelogenous leukemia undergoing donor peripheral blood stem cell~     transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood~     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a~     donor are infused into the patient they may help the patient's bone marrow make stem cells,~     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Removing a subset of the~     T cells from the donor cells before transplant may stop this from happening.~   "
63894|NCT02220972|"~     This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study~     to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well~     controlled partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are~     experiencing sleep onset insomnia.~   "
63895|NCT02220959|"~     the purpose of this study is to determine if 60 meter test done prior to surgery is a~     predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.~   "
63896|NCT02220946|"~     vaginal electrical stimulation improves female sexual dysfunction~   "
63897|NCT02220933|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     disability of patients suffering from progressive multiple sclerosis and especially those~     with gait impairment.~   "
63898|NCT02220920|"~     The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284)~     in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.~   "
63899|NCT02220907|"~     The purpose of this study is to evaluate the safety and efficacy of co-administration of~     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and~     have inadequate glycemic control.~   "
63900|NCT02220894|"~     In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small~     cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to~     35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin +~     paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants on the~     platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed~     maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is~     that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.~   "
63901|NCT02220881|"~     The primary objective of this study is to investigate the effectiveness of mold making~     silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to~     determine the compliance of mold making silicone toe separator, the change in pain level~     and, including, the satisfaction of the participants after using mold making silicone toe~     separator.~   "
63902|NCT02220868|"~     The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the~     treatment of hepatitis c in patients taking stribild.~   "
63903|NCT02220855|"~     Thymic tumors are rare tumors, but represent the most common tumors of the anterior~     mediastinum. Thymoma has an indolent course in advanced disease and has the propensity to~     spread to the pleura. In first line therapy, combination chemotherapy produces responses in~     approximately 80% of patients. A number of single agents have activity in recurrent disease,~     but none are curable. Patients with recurrent thymoma have limited treatment options, and~     thus novel target modalities are needed.~      At the Indiana University Simon Cancer Center (IUSCC), more patients with advance thymoma~     are seen than any other institution in the country. Our main hypothesis is the PI3K pathway~     is an important driver for growth and metastasis of thymoma and that inhibition of the PI3K~     pathway is expected to produce clinically meaningful response in patients with recurrent~     thymoma.~   "
63904|NCT02220842|"~     This open-label, multicenter, global study is designed to assess the safety, tolerability,~     and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab administered~     in combination to patients with refractory or relapsed follicular lymphoma (FL) or diffuse~     large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 44~     months.~   "
63905|NCT02220829|"~     Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop~     symptomatic urinary problems .These symptoms can significantly diminish a patient's quality~     of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease~     resistance to urinary flow.~      This multi-institutional phase III trial is designed to compare standard of care versus~     preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group,~     whose treatment consists of radical radiation therapy. We plan to recruit 188 patients~     across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation~     therapy or if/when symptoms appear.~   "
63906|NCT02220816|"~     Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6~     months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of~     competitive versus non-competitive attentional training. Competitive training will include~     fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations~     and fifteen 1-hour sessions of competitive attentional games designed for this purpose using~     a new virtual reality system (conventional liquid-crystal-display screen with an infrared~     LED array to facilitate multi-touch experience embedded in a conventional table). Progress~     will be evaluated by pre and post measurement of attentional neuropsychological tests,~     subjective reports of global attention, usability and motivational scales. Our hypothesis is~     that competitive training is more effective in improving attention than conventional~     training in the chronic phase after acquired brain injury.~   "
63933|NCT02220465|"~     The study's primary aim is to test the hypothesis that an intervention that integrates low~     to moderate physical activity (walking) with evidence-based smoking cessation counseling~     (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a~     behavioral predictor of smoking relapse) as compared to standard care smoking cessation~     counseling (control group) in a sample of low-income sedentary male and female smokers. The~     study will also test the hypothesis that the participants randomized to the LMPA~     intervention will have greater quit rates at one-week and one-month post quit day follow~     ups.~   "
63907|NCT02220803|"~     This is a short term open, randomized cross over trial to explore and compare the efficacy~     of pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA)~     related hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ),~     Continuous Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week~     wash-out period all study participants will receive the alternative treatment regimen. The~     total length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on~     blood pressure,hemodynamics and sleep apnea will be investigated.~      Study hypothesis:~      Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce~     blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will~     induce a direct pharmacological effects on vascular stiffness as evidenced in overnight~     non-invasive assessments of vascular stiffness and that this effect will be particularly~     strong in patients also responding with a reduction of blood pressure.~   "
63908|NCT02220790|"~     The purpose of the study is to 1) define the operating characteristics of fungal biomarker~     assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine~     the change in fungal biomarker assay results in children who develop invasive candidiasis,~     and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive~     candidiasis and those with invasive candidiasis for future testing of fungal biomarker~     assays and development of new fungal biomarker assays. The study will assemble a prospective~     cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples~     for biomarker testing will be obtained at the time a patient has a clinical indication for~     blood culture attainment. Additional blood sampling will be performed on the sub-set of~     patients that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and~     NPV of biomarker assays will be determined for each biomarker assay. No PHI will be stored~     in the database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.~   "
63909|NCT02220777|"~     This is a 4-part study. Part I assesses the safety and tolerability of single ascending~     doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is~     similar to part I except that the study is conducted in young, vasectomized males.~      Part III assesses the effect of food (fed or fasted conditions) on ASP8477 in postmenopausal~     subjects.~      Part IV assesses the drug-drug interaction between ASP8477 and omeprazole in postmenopausal~     subjects.~   "
63910|NCT02220764|"~     The objective of this prospective clinical study is to investigate the differences in the~     complication rates between tooth- and implant- supported zirconia based fixed dental~     prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference~     in the complication rates between implant- supported and tooth- supported zirconia FDPs.~   "
63911|NCT02220751|"~     The purpose of the study was to monitor the activity of periodontal disease and suggest~     potential biomarkers related to active periodontal disease in patients with chronic~     periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the~     evaluation of the profile of gene expression of periodontal sites and the evaluation of~     inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but~     only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2~     months after non-surgical periodontal therapy. The final sample was: 21 patients with~     chronic periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM~     group). Fifteen periodontal- and systemically healthy patients were included as control~     group. Saliva collection, glycated hemoglobin measurement, periodontal examination and~     radiographs were conducted before and 2 months after non-surgical periodontal therapy.~     Radiographic subtraction was performed from pairs of the radiographs. Measurements of the~     areas with density loss were recorded. Gingival biopsies of active and non-active sites with~     similar clinical parameters were harvested for Real Time Polymerase Chain Reaction Array~     gene expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling~     Immunoassay for analysis of protein expression. The clinical attachment loss mean was higher~     in the PD+DM group (p<0.05). There was a high correlation between clinical attachment loss~     and darkened radiographic areas in active sites of the PD group and PD+DM group. When~     compared PD group to PD+DM, patients with diabetes had an up-regulated profile. Active sites~     of the PD group showed nine genes (specific chemokines, interleukins and receptors)~     differentially expressed with an up-regulated profile. Active sites of the PD+DM group~     showed six genes (specific chemokines, interleukins and receptors) differentially expressed~     with an up-regulated profile. After periodontal therapy, there was a reduction of some~     salivary proteins in both periodontal groups, but not significant. In conclusion, it was~     possible to identify genes differentially expressed in active sites from both groups, which~     may be considered useful in indicating potential biomarkers for the diagnosis of~     periodontitis; salivary proteins show a trend in distinguishing the standard of health and~     disease and may be used in the future as potential biomarkers of periodontitis with or~     without diabetes.~   "
63912|NCT02220738|"~     This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple~     doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.~   "
63913|NCT02220725|"~     The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the~     anticoagulation effect of Rivaroxaban.~   "
63914|NCT02220712|"~     To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot~     formulation in patients with schizophrenia after repeated administration by injection into~     the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals~   "
63915|NCT02220699|"~     All Danish general practices have a data capture system that collects selected data from the~     electronic patient record. These data are used for various quality assurance purposes. The~     aim of the study is to evaluate the quality assurance system/program that identifies~     patients having an increased risk of osteoporosis.~   "
63916|NCT02220686|"~     The purpose of the study is to see if vascular physicians (your provider) using a~     combination of proven smoking cessation tools in an organized way can help vascular patients~     quit smoking better than usual.~      The doctors where you are being treated have been chosen to either provide:~      the combination therapy of giving you advice, considering prescribing medications to help~     you quit smoking, and referring you to a phone quitline, or to continue their usual smoking~     cessation practices (which may include all, some, or none of the treatments above).~   "
63917|NCT02220673|"~     Primary objective: To investigate the safety and local tolerability of increasing cumulative~     doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT~     administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation~     solutions without BHT (placebo to BHT given by RMT B and placebo given by~     hydroxylfluoralkane metered dose inhaler (HFA MDI)). In a first step, the trial was~     performed in healthy subjects and - if no safety concerns arose - in a second step in~     patients with mild asthma who were sensitive to metacholine in a respective challenge test.~     Secondary objective: To explore the pharmacokinetics (PK) of BHT.~   "
63945|NCT02220309|"~     This research study is aimed at understanding behaviors and brain circuits that relate to~     anxiety and depression. Our goal is to learn which circuits of the brain are involved in~     anxiety and how these circuits might affect daily functioning. The ultimate goal of the~     study is to apply this knowledge to help personalize treatments.~      We invite anyone who has recently experienced any symptoms of anxiety and/or depression to~     participate (no diagnosis is required to participate).~   "
63918|NCT02220660|"~     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and~     CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following~     inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic~     solution for inhalation, EIS) with the systemic exposure following inhalation of the free~     dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX~     (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS~     and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to~     compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903~     XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after~     a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed~     dose combination and the free dose combination, respectively; to compare the safety and~     tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed~     dose combination and as the free dose combination, respectively.~   "
63919|NCT02220647|"~     Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose~     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850~     mg administered together~   "
63920|NCT02220634|"~     The purpose of this study is to see if Regadenoson may offer improved ease of use, single~     dose administration, and better tolerance for testing for pulmonary hypertension than iNO.~     You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,~     blood tests, and an ECG.~   "
63921|NCT02220621|"~     Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of~     myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as~     symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual~     abortion, which seriously affect the patients quality of life.~      Preventing IUA has been tried using different methods such as barrier or stent in order to~     separate the opposing endometrium during the tissue healing processes. Although some~     successes have been reported there are still some challenges need to be dealt with.~      One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a~     natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound~     repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA~     in clinical studies.~      A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with~     proprietary technologies. This product is a highly viscoelastic crosslinked gel that~     overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation~     in vivo. For this product, the results of animal experiments and various safety features~     have been designed and tested conforming to the national regulations and standards. In order~     to launch this product to the market, this prospective, randomized and controlled clinical~     trial is designed and will be performed to verify its safety/efficacy.~   "
63922|NCT02220608|"~     The purpose of this research study is to determine the highest dose of a drug called~     bortezomib that can be given with a drug called G-CSF before stem cell collection to help in~     the mobilization of stem cells.~   "
63923|NCT02220595|"~     This study compares cognitive function after carotid endarterectomy and stenting.~   "
63924|NCT02220582|"~     The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,~     multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at~     contextual risk factors and novel predictors of hard events over a period of four years.~      The unique features of this initiative are:~        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)~        -  Contextual factor analysis (including community environmental profile assessments)~        -  Record linkage follow-up of individuals to health services (administrative) databases~          for major morbidity and mortality events and health services utilization~   "
63925|NCT02220569|"~     PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving~     chemotherapy early on in order to avoid irreversible damage. In addition to that, we will~     test if the PhysioFlow is non-inferior to the conventional MUGA scan.~   "
63926|NCT02220556|"~     Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral~     type. Up to 50 patient can be included into each cohort.~   "
63927|NCT02220543|"~     The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new~     primary care intervention Back on Track as compared to usual primary care in patients with~     non-specific chronic low back pain in which disability levels are moderate and the role of~     psychosocial factors to this disability is at maximum low (classified as WPN2).~   "
63928|NCT02220530|"~     This study aims to assess the impact of the use of sedation on the overall quality of the~     colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific~     and technical quality, perceived quality and safety.~   "
63929|NCT02220517|"~     The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with~     additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more~     prostate cancers than targeted MR-guided in-bore prostate.~   "
63930|NCT02220504|"~     This open-label, non-randomized, prospective study will evaluate the risk of symptoms~     recurrence during the three years after antipsychotic discontinuation in a sample of~     functionally recovered first-episode patients with schizophrenia spectrum disorder.~   "
63931|NCT02220491|"~     Patients with brain metastases with expected life expectancy of 3-6 months are typically~     treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period.~     This study will compare this with volumetric modulated arc therapy (VMAT) which is capable~     of delivering 15 Gy in one single session to identified disease within the brain but sparing~     the normal surrounding brain tissue. Primarily the study will assess whether it is possible~     to recruit sufficient patient numbers to a trial of this type. It will also compare~     effectiveness, side effects and quality of life between the two treatment methods.~   "
63932|NCT02220478|"~     The primary purpose of this pilot study is to evaluate the accuracy of cup placement between~     two instrumentation technologies: Cutting Guide and Conventional Instrumentation.~   "
63946|NCT02220296|"~     This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a~     range of single doses of subcutaneous insulin 338.~   "
63947|NCT02220283|"~     Compare the renal complication of endovascular and open repair of acute aortic dissection by~     including patient treated at NTUH in 2010~2013.~   "
63934|NCT02220452|"~     -  The perioperative period can be a significant source of psychological burden, anxiety~          and fear for patients~        -  Both pharmacological and non-pharmacological methods have been proposed in order to~          alleviate perioperative stress~        -  Music is one of the non-pharmacological methods which have been used in this context,~          with favorable effects both preoperatively and postoperatively~        -  The attenuation of perioperative stress through music listening is probably due to the~          activation of emotional and cognitive processes that evoke feeling of pleasure and can~          distract patients' attention from fear and unpleasant thoughts related to the surgical~          procedure~        -  Little information is available regarding the effect of intraoperative music listening~          on anesthetized, unconscious patients~        -  There is a notion that general anesthesia does not completely abolish auditory~          perception and that some processing of intraoperative events can occur in unconscious~          patients, even in the absence of postoperative recall~        -  The investigators hypothesis is that intraoperative music listening can decrease~          anesthetic requirements and reduce sevoflurane consumption in female patients subjected~          to abdominal hysterectomy for benign disease.~   "
63935|NCT02220439|"~     This is a proposal for a nested case‐control study within an ongoing rotavirus vaccine~     immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the~     fecal microbiota composition and diversity of infants who do (control) and do not (case)~     demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for~     vaccination dose, age and breast‐feeding practices.~   "
63936|NCT02220426|"~     The primary goal of this study is to evaluate the feasibility of detecting Brown Adipose~     Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.~      In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to~     assess image quality using a prototype surface coil and pulse sequence following inhalation~     of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.~      The investigators are testing the abilities of xenon MRI to see brown adipose tissue and~     detect its thermogenic activity.~   "
63937|NCT02220413|"~     The purpose of this study is to investigate what proportion of obese women will have a~     self-reported delay in lactogenesis II (breastmilk coming in) compared to women with a~     normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed~     lactogenesis II.~      We will compare two group of women for delayed lactogenesis II, one group with obese women~     (BMI>30) and one group of women with a normal weight (BMI<30).~      The secondary objective is to assess what other factors influence the self-reported delayed~     lactogenesis II.~   "
63938|NCT02220400|"~     Previous study demonstrated that neuroinflammation induced by surgery is the main cause of~     the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved~     to be an anti-inflammation agent. In present study investigators hypothesized that low dose~     ketamine would prevent the cognition decline after orthopedic surgery in aged patients.~   "
63939|NCT02220387|"~     The objective of this study is to investigate molecular, cytological and genetic features of~     occupational chronic obstructive pulmonary disease (COPD) in conditions of different~     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and~     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar~     lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming~     growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene,~     rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3~     (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to~     polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between~     genotype and phenotype characteristics, such as an inflammation activity, assessed by~     C-reactive protein (hsCRP) and tumor necrosis factor-α (TNF α) serum concentration, in~     different occupational COPD groups will be studied. The hypothesis is that the mechanisms~     underlying disease development and progression are different due to environmental risk~     factor that reflex in differs in disease attributes - molecular biomarkers, cytology results~     and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in~     smokers therefore COPD can be subdivided into ecological phenotypes according to~     environmental risk factor.~   "
63940|NCT02220374|"~     Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment~     involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are~     amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some~     joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are~     investigating whether supportive taping of the painful finger joint reduces pain and~     improves function, and whether this treatment could be used to substitute pain killers,~     injections or surgery. We hypothesise that supportive finger tape may improve pain, improve~     the stability of the joint and thereby improve day-to-day hand function too. We will~     investigate this through a two-group parallel randomised controlled trial whereby one group~     will receive the treatment taping and the other group will receive a theoretically placebo~     taping configuration. We will measure pain daily, hand function and adverse events.~   "
63941|NCT02220361|"~     Hemabate is often used for gynecological patients. Hemabate is associated with many side~     effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is~     reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period.~     We design this clinical trial to find if dexmedetomidine can prevent the side effects of~     hemabate in Cesarean Section patients.~   "
63942|NCT02220348|"~     The purpose of this study is to determine the amount of linaclotide and its active~     metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of~     linaclotide (145 μg or 290 μg) in lactating women receiving the drug therapeutically.~   "
63943|NCT02220335|"~     A number of 100 patients with pulmonary arterial hypertension associated with the left Heart~     failure scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to~     either PADN or control group.~   "
63944|NCT02220322|"~     Age-related change of femur is not well-known. The investigators investigated the~     longitudinal changes of femur.~   "
63948|NCT02220270|"~     The purpose of this study is to determine the safety, performance and efficacy of the~     Hyperion™ Occluder Systems during treatment of ASD and PDA patients.~   "
63949|NCT02220257|"~     Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets~     of Langerhans in the pancreas. Symptoms of diabetes present when the mass of~     insulin-producing cells reaches a point where insulin concentration does not suffice to~     maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis~     of diabetes and initiation of insulin therapy. This phenomenon is called a remission.~      The aim of this study is to asses the influence of occurrence and duration of remission on~     development of chronic complications of diabetes and patients outcome.~   "
63950|NCT02220244|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     visual improvement of patients suffering from chronic visual loss resulting from multiple~     sclerosis related optic neuritis.~   "
63951|NCT02220231|"~     Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for~     excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with~     one-lung ventilation during VATET may cause hemodynamic instability due to the compression~     of intrathoracic structures. The purpose of this study is to evaluate the effects of~     capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the~     transesophageal echocardiography.~   "
63952|NCT02220218|"~     The purpose of this study to evaluate the bioequivalence (is the amount same in both the~     pills) of metformin component of the canagliflozin and metformin immediate release (IR)~     fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered~     with canagliflozin tablet in healthy fed and fasted participants.~   "
63953|NCT02220205|"~     Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In~     order to make them accessible to women, health care providers must be trained to insert~     them. Physicians, physician assistant, and nurse practitioners often learn how to do so by~     first learning about IUDs, then practicing on a model that the IUD manufacturer provides.~      Educators have recently been using more sophisticated models to teach clinical skills such~     as surgical procedures. We are investigating whether these models may be more useful in~     teaching IUD insertion.~   "
63954|NCT02220192|"~     This is a pilot study to test the short-term effectiveness of an alternative treatment~     approach for precancerous cells of the cervix. The study will also explore whether this new~     treatment is feasible to perform and if it is acceptable to patients.~   "
63955|NCT02220179|"~     In this project we invite 9.000 children and young persons in Denmark and their foster~     parents and staff at the residential institutions to participate in a cluster randomized~     controlled intervention study where we aim to test the effectiveness of a web based~     knowledge and inspiration program about resilience for children, adolescents and adults~     (called myresilience.org). The complete CONSORT trial protocol is available at~     http://myresilience.org/ at the subsite 'about us'.~   "
63956|NCT02220166|"~     Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient~     Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent~     with non toxicity and other suggestive of toxicity. We recently reported results of a single~     administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD),~     while assessing symptoms and changes of intestinal permeability. Although results of~     intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically~     well tolerated.~      The aim of the present study was to assess safety of 60 days of administration of Tm (100~     grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on~     clinical, serological and histological parameters in Celiac Disease patients on remission~     after 1 year of GFD.~   "
63957|NCT02220153|"~     This study is designed to evaluate the safety and tolerability of single ascending doses of~     UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.~   "
63958|NCT02220140|"~     In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a~     randomized controlled intervention study where we aim to test the effectiveness of a web~     based knowledge and inspiration program about resilience for children, adolescents and~     adults (called myresilience.org). The complete CONSORT trial protocol is available at~     http://myresilience.org/ at the subsite 'about us'.~   "
63959|NCT02220127|"~     Gamma Knife Radiosurgery (GKR) is a well-established treatment modality for brain metastasis~     (Chiou 2013; Salvetti, Nagaraja et al. 2013). Large multicentre series have been published~     on patients with single and multiple cerebral metastases, treated with GKR over a period of~     30 years (Karlsson, Hanssens et al. 2009). Multiple institutions have reported a~     consistently high local tumour control rate of 80%-90% following GKR (Chang, Lee et al.~     2000; Da Silva, Nagayama et al. 2009; Salvetti, Nagaraja et al. 2013).~      There is controversy over the use of GKR and/or Whole Brain Radiotherapy (WBRT) in patients~     with multiple metastases. WBRT provides a lower rate of distant recurrences, whereas GKR~     achieves good local control of treated lesions without the deleterious side effects of~     radiotherapy (Lippitz, Lindquist et al. 2014). This discussion is mainly focused on the risk~     of distant recurrences, which is lower if WBRT is given. There is evidence showing that~     Radiosurgery (RS) based on high contrast/resolution stereotactic MRI decreases the incidence~     and lengthens the time to distant recurrences (Hanssens, Karlsson et al. 2011). As a result,~     the current tendency is to treat all the lesions visible in high contrast/resolution images~     the day of Gamma Knife; which is followed by regular MRI follow ups and subsequent GKR for~     distant recurrences in order to avoid/delay WBRT.~      It has been estimated that more than a half of distant recurrences will grow from tumour~     cells that were already in the brain (as micrometastases) when radiosurgery is delivered,~     but not much has been studied on the optimal prescription and radiation delivery method for~     these lesions. There is controversy over which collimator should be used when treating~     micro-metastases (BmM). These lesions can either be treated with the 4mm collimator at an~     isodose between the 40% and 90%, or the 8mm collimator at an isodose above 90%. The 8 mm~     collimator is thought to offer better Local Control Rate (LCR) with the advantage of faster~     delivered treatments, while the 4 mm collimator is considered to be safer, given its steep~     dose fall-off. It is the aim of this study to find out which of the 4 mm or 8 mm collimators~     can achieve the higher LCR with less complications. A large number of lesions will be~     randomised to either the 4 or the 8 mm collimator and the patients followed up to evaluate~     clinical efficacy.~   "
63996|NCT02219646|"~     Given the protective effect of nitric oxide (NO) on the endothelium and the results obtained~     so far in short-term, continuous treatment with phosphodiesterase-5 (PDE5) inhibitors on~     parameters of endothelial function, we hypothesise that chronic treatment with vardenafil~     can prevent or delay the deterioration of systemic endothelial function in patients with~     type 2 diabetes mellitus. The favourable effect of PDE5 inhibitors on sexual function in~     these patients has been convincingly demonstrated in the past. Here we hypothesise that~     vardenafil treatment can have beneficial effects on the vascular physiology in other body~     districts, possibly preventing the development of microangiopathy and atherosclerotic~     cardiovascular disease in these patients.~      The main goal of this study is therefore to monitor the endothelial dysfunction during~     continuous treatment with vardenafil for 6 months; object of the study will be endothelin 1~     and other known parameters of endothelial damage in newly diagnosed patients with type 2~     diabetes mellitus.~   "
63960|NCT02220114|"~     The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the~     dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin~     (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6~     years) and 500 mg granules for oral solution sachets (for infants and children below 6~     years). Sabril™ is not adapted for administration to infants when a fraction of the sachet~     is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often~     required.~      This study is a descriptive, non-randomized, open label multi-centric acceptability study in~     infants and children affected with infantile spasms. The primary objective is to describe~     the adherence to the new formulation. Secondary objectives include:~        -  evaluation of the palatability and user-friendliness of the new treatment,~        -  evaluation of the pharmacokinetic parameters of the new formulation,~        -  PK parameters,~        -  evaluation of the tolerance,~        -  measurement of taurine plasma levels. This study will recruit up to 40 patients with~          infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23~          clinical sites in France.~   "
63961|NCT02220101|"~     Comparison of four methods for measuring temperature perioperatively in patients scheduled~     for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme;~     Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner.~     The study is a single-center, observational study carried out by the Central Surgical and~     Intensive Section at Vestfold Hospital Trust.~   "
63962|NCT02220088|"~     Transarterial chemoembolization (TACE) is considered the gold standard for treating~     intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not~     specify the criteria for repeating TACE.The study,conducted in Europe ，recently published in~     the journal of Hepatology shows the ART score of >=2.5 prior the second TACE identifies~     patients with a dismal prognosis who may not profit from further TACE sessions. However,in~     clinical practice，we also found some patients who showed TACE-resistant at the beginning of~     treatment may access to get objective response of retreatment with TACE.So the investigators~     conduct this prospective,randomized controlled study to find out whether the patient who~     showed TACE-resistant can obtain survival benefit from retreatment with TACE.~   "
63963|NCT02220075|"~     LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of~     LMA insertion. When the investigators evaluate the LMA position, the investigators can use~     fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway~     pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this~     will bring high risk of aspiration. Recent studies reported the LMA position after general~     anesthesia induction not after operation. Therefore, the investigators will observe the LMA~     position three times; after general anesthesia induction, after caudal block, and after~     operation as well as the difference regarding to spontaneous and controlled ventilation.~   "
63964|NCT02220062|"~     Pancreatic cancer related pain can be difficult to control, even with high doses of~     narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic~     ultrasound guided celiac plexus neurolysis) is well established as an effective technique~     for controlling pain and reducing narcotic requirements in patients with pancreatic cancer.~     Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it~     allows for direct injection into individual celiac ganglia to perform celiac ganglia~     neurolysis. This more precise delivery of therapeutic drug will offers the potential for~     enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial~     aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac~     ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus~     neurolysis) in providing relief from pancreas cancer-related pain.~   "
63965|NCT02220049|"~     VELCADE has demonstrated marked activity in haematological cancers leading to registration~     (MM, MCL).~      Currently only biweekly or weekly regimens have been explored. Key signalling pathways which~     are aberrant in haematological cancers are also present in solid tumors.~      VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as~     a single agent & in combination with chemotherapy in solid cancers has shown modest and real~     anti-tumor activity but insufficient for Phase III development.~      VELCADE PK exposure may be inadequate in solid tumors compared to liquid cancers. VELCADE~     daily low dose administration may allow a greater PK exposure to be achieved, which is~     tolerated~      Hypotheses:~      VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses~     VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S~     proteasome inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD~     results in improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially~     cross the threshold required for clinically significant anti-tumor activity in solid~     cancers).~      Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome~     inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have~     increased anti-tumor activity compared to monotherapy alone.~   "
63966|NCT02220036|"~     This is a double-blind randomized clinical trial which will start at June 2014 and end on~     June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the~     sample size calculated 80 persons (40 persons for control group and 40 persons for patient~     group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood~     Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular~     Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium~     supplement (250 milligram) and the other group will receive placebo which is similar to the~     magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will~     complete 4 physical activity and 4 dietary records. Outcome measurements including~     metabolic, renal and inflammatory profiles will be measured at the beginning and end of the~     study as well as anthropometric measurements.~   "
63967|NCT02220023|"~     The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and~     pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with~     pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on~     invasive catheterization as well as healthy subjects. Measurements will also be made after~     high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The~     investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to~     measure dynamic changes in RV-pulmonary vascular function in patients with~     vasodilator-responsive PAH.~   "
63968|NCT02220010|"~     Dividing pancreas when performing left-sided resections opens the risk for leakage from the~     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding~     abdominal tissues with abscess formation producing systemic inflammation and potential~     lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective~     drainage reduces healing time. A pancreatic stent could theoretically improve the drainage~     of pancreatic juice into the duodenum and by this shorten the healing time still further.~      Pre operative prophylactic stenting of the pancreas before division of the parenchyma has~     not shown a positive effect on fistula formation.~      In an open randomized multicenter clinical trial we want to test the hypothesis that a~     reduced fistula healing time, in left sided pancreatic resections, could be reduced by~     introducing a pancreatic stent when on post operative day 3 or later a B och C fistula~     (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by~     randomizing between pancreatic stent with drains versus only drains.~   "
63969|NCT02219997|"~     The purpose of this study is to compare the reaction time (as measured by braking reaction~     time in seconds during simulated driving) under glare and no-glare conditions in subjects~     implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.~     This study will enroll subjects previously implanted with IOLs in both eyes for at least 3~     months.~   "
63970|NCT02219984|"~     This is a phase 4 cohort prospective, open, national, multicentre study that collects data~     on history of patients treated chronically with anticoagulant drugs, including the novel~     direct oral anticoagulants (DOACs). The Registry is designed solely for observational~     purposes and is not intended to have any influence on the treatment of the single patients~     included.~      Patients are included when they start the anticoagulant treatment, whatever the drug used,~     or when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral~     anticoagulants, provided that the therapy is expected to last at least 3 months.~      The general aims of the study are to provide a better evaluation of efficacy and safety of~     different treatment options, and to improve our understanding of the risks/benefits of the~     various anticoagulant drugs and the different therapy options.~      The Registry is open to the participation of clinical centres or individual professionals~     (now called Participants) that are involved with management of anticoagulated patients.~   "
63971|NCT02219971|"~     The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single~     intravenous injection Kukoamine B Mesilate in health volunteer~   "
63972|NCT02219958|"~     Hypertension (HT) is one of the major cause of morbidity and among the top 10 causes of~     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has~     initiated service improvement through introducing the risk assessment and management~     programme (RAMP) to improve the quality of care (QOC) for HT patients in general outpatient~     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to~     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the~     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of~     the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital~     will be invited to complete a structured evaluation questionnaire. The data of all patients~     who have enrolled into the RAMP for more than one year will be included in the evaluation on~     the process and outcomes of care.~      One thousand two hundred and forty-eight age and disease matched control patients who have~     not been enrolled into the RAMP programme will be selected for the comparison in the~     outcomes of care. A hundred and thirty participants will be followed up by telephone to~     evaluate the effect of the programme in quality of life (QOL), patient enablement, and~     global rating of change in health condition at baseline and 6 months after enrolment. Data~     on the process of care will be retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the criterion process of care, and achieved the target blood pressure levels.~      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC~     criteria will be calculated. The changes in the clinical and patient reported outcomes of~     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample~     t-test. The clinical outcomes between RAMP subjects and control group will be compared by~     independent sample t-test or Chi-square test.~      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     RAMP programme can achieve improvement in QOC for HT patients. The information will be used~     to guide service planning and policy decision making.~   "
63973|NCT02219945|"~     Electronic noses detecting patterns of volatile molecules have recently been introduced for~     different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins~     et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.~     Here the investigators test a production type point-of-care hand-held device with less~     detectors. The investigators explore factors such as food intake, smoking, and co-morbidity,~     as well as the impact of TB treatment, and address the question whether the device could~     help monitor disease and response to treatment.~   "
63974|NCT02219932|"~     The primary objective is to determine whether prolonged-release fampridine (10 mg twice~     daily) has a clinically meaningful effect on patient-reported walking ability over a 24-week~     study period. The secondary objectives are: To determine whether prolonged-release~     fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and~     static balance, physical impact of Multiple Sclerosis (MS), and upper extremity function~     over a 24-week study period; To evaluate criteria for early assessment of response to~     fampridine that can predict clinically meaningful benefits in walking ability and balance;~     To assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over~     a 24-week treatment period.~   "
63975|NCT02219919|"~     This randomized clinical trial will investigate changes in pain intensity and nociceptive~     gain processing after the application of either physical therapy or surgery in women with~     carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain~     intensity, widespread pressure pain sensitivity and segmental thermal changes after the~     application of a physical therapy program based on desensitization maneuvers of the central~     nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up~     periods. We hypothesize that the physical therapy intervention targeted to desensitization~     of the central nervous system is more effective than surgical intervention for modulating~     altered nociceptive gain processing in women with CTS.~   "
63997|NCT02219633|"~     The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652~     cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.~   "
63998|NCT02219620|"~     To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and~     cognitive functioning in residents living in a community-based adult long-term care~     facility.~      Hypothesis 1: Residents who participate in the MiM group will improve in emotional~     functioning, as compared to residents in the control group.~      Hypothesis 2: Residents who participate in the MiM group will improve in cognitive~     functioning, as compared to residents in the control group.~   "
63976|NCT02219906|"~     Metabolic syndrome is a group of risk factors that increase a patient's likelihood for heart~     attack, stroke and diabetes. Our research is aimed at understanding whether a drug,~     resveratrol, commonly found in grapes and red wine, would have any benefit in reducing risk~     factors in patients that have metabolic syndrome. Despite the use of aspirin and cholesterol~     reducing medications, patients with metabolic syndrome still often have sticky platelets and~     dysfunctional lipid profile. This is likely due to inflammation and high oxidative state. In~     animal studies, this drug has reduced platelet stickiness and reduced oxidative stress.~     However, the effects of this drug have not been researched in patients with metabolic~     syndrome.~      We are interested in studying whether the benefits of resveratrol described in animal models~     can be translated to patients with metabolic syndrome who display high markers of oxidative~     stress. We plan to give a short intervention of drug to patients and then determine if the~     drug successfully:~        1. Decreases the stickiness of platelets. This is important because sticky platelets are~          more likely to form clot and contribute to plaque formation.~        2. Reduce the circulating dysfunctional HDL. HDL and its protein and lipid constituents~          help to inhibit oxidation, inflammation, activation of the blood vessel wall,~          coagulation, and platelet aggregation. Dysfunctional HDL, as occurs in metabolic~          syndrome patients, cannot properly protect against atherosclerosis.~   "
63977|NCT02219893|"~     The purpose of this study is through a phase I/II clinical trial to assess the safety and~     toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative~     day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)~     for peritoneal metastases from colorectal cancer (CRC).~   "
63978|NCT02219880|"~     The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised,~     placebo-controlled study.~   "
63979|NCT02219867|"~     Ketamine has been safely used for induction and maintenance of anesthesia for decades and~     more recently has been used for chronic pain. Ketamine is a noncompetitive, high-affinity~     antagonist of the N-methyl-D-aspartate type glutamate receptor, with additional effects on~     dopamine and μ-opioid receptors. During the last 9 years several uncontrolled reports have~     been published, showing a rapid and impressive effect of ketamine in TRD patients (Berman,~     Cappiello et al. 2000; Zarate, Singh et al. 2006; Mathew, Murrough et al. 2010; Aan Het Rot,~     Zarate et al. 2012; Mathew, Shah et al. 2012; Murrough, Iosifescu et al. 2013). Recently~     three placebo-controlled trials showed that a single dose of sub-anesthetic, (0.5 mg/kg)~     slow intravenous (IV) ketamine improves depressive symptoms dramatically. Across studies, a~     clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25~     patients. Nonetheless, all but two patients relapsed <2 weeks post-ketamine (Zarate, Singh~     et al. 2006; aan Het Rot, Zarate et al. 2012). Rot et al. showed that repeated IV ketamine~     infusions prolongs the duration of improvement.~      The investigators believe that the data presented above allows us to provide ketamine~     treatment here in the Sheba Medical Center for TRD patients.~   "
63980|NCT02219854|"~     Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric~     cancer is popular in East Asian countries. However, the long-term follow-up outcome based on~     randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic~     distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe~     procedure by experienced surgeons in high-volume specialized hospitals. However, the~     application of it is still limited because of lack of solid evidence on the oncologic~     efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is~     estimated up to 80 percent of all gastric cancer cases in China. Before the clinical~     application of laparoscopic procedure for the treatment with curative intent to advanced~     gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy~     must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and~     open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer~     based on a well designed RCT is needed.~   "
63981|NCT02219841|"~     This prospective randomized pilot study aims to evaluate the impact of aggressive life style~     modification in terms of calorie-controlled diet and supervised exercise on outcome of~     catheter ablation in overweight and obese patients with atrial fibrillation.~      Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen~     improves the chances of freedom from recurrence following catheter ablation.~   "
63982|NCT02219828|"~     Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized~     autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been~     shown by the achievement of complete responses after treatment with the recombinant~     IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed~     study is designed to demonstarate the efficacy of anakinra in RP.~   "
63983|NCT02219815|"~     The PREHAB study is a clinical trial where frail patients waiting for heart surgery are~     randomly chosen to either receive the current standard of care or to participate in an~     8-week exercise/education program at a community-based cardiac rehabilitation facility.~     Patients can wait for elective heart surgery for as long as 3-4 months. During this time,~     individuals are often fearful of making things worse, causing them to stop being active and~     further deteriorate their physical condition. This wait period presents a potential~     opportunity for health care providers to engage the patient to take control of their~     self-managed care prior to surgery with the intent of improving post-surgical outcomes.~     Patients randomized to the PREHAB intervention group will participate in supervised exercise~     twice per week in a program designed to improve physical functioning and exercise capacity.~     The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an~     elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical~     activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1~     year postoperatively, and improve overall quality of life.~   "
63999|NCT02219607|"~     The use of epidural anesthesia and postoperative analgesia influences fluid balance~     following colorectal surgery.~      Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate~     intravascular fluid load and predict outcome after colorectal surgery.~   "
64023|NCT02219295|"~     We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.~     There ist growing evidence, that components of the taste signalling system, including the~     taste receptor proteins , have important functions in the regulation of metabolic parameters~     in non-gustatory tissues.~   "
63984|NCT02219802|"~     Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and~     drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in~     primary percutaneous coronary intervention (PPCI). However, this did not result in a~     reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns~     of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and~     feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short-~     and long-term clinical results, with sustained safety and efficacy at 12 months follow-up.~     To date little is known about the long-term effects of this treatment modality in STEMI.~     Besides, angiographic follow-up is of great clinical importance by giving insight on the~     treated infarct lesion and to assess the functional angioplasty result.~      Objective: This randomized controlled, non-inferiority trial is mainly designed to~     prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only~     strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction~     (STEMI).~   "
63985|NCT02219789|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with fulvestrant in treating patients with hormone positive breast cancer that has spread to~     other parts of the body or has spread from where it started to nearby tissue or lymph nodes~     and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones~     made by the body and they can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the~     body makes. Giving alisertib together with fulvestrant may be a better treatment for breast~     cancer.~   "
63986|NCT02219776|"~     Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery~     propionibacterium acne remains a leading cause of post-operative infections. The purpose of~     this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to~     chlorhexidine-impregnated skin preparation in attempting to lower the colonization~     propionibacterium acne prior to surgery. This study will take cultures from patients who are~     randomly assigned into groups that receive and do not receive benzoyl peroxide as additional~     skin prep prior to elective shoulder surgery and compare quantified culture results.~   "
63987|NCT02219763|"~     Evaluate the impact of a 12-week behavioral weight management program on body weight and~     quality of life. We hypothesize that participants will lose body weight and see improved~     quality of life after program completion.~   "
63988|NCT02219750|"~     Comparison of efficacy and safety of different insulin regimens between basal bolus and~     premixed insulin in poorly controlled type 2 diabetes~   "
63989|NCT02219737|"~     This phase I trial studies the side effects and best dose of ibrutinib when given together~     with rituximab, ifosfamide, carboplatin, and etoposide (combination chemotherapy) in~     treating patients with diffuse large B-cell lymphoma (DLBCL) that has returned after a~     period of improvement (relapsed) or has not responded to treatment (refractory). Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as, rituximab, ifosfamide, carboplatin, and etoposide, work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving ibrutinib together~     with combination chemotherapy may be a better treatment for patients with relapsed or~     refractory DLBCL.~   "
63990|NCT02219724|"~     This is a first-in-human, Phase I, open-label, multicenter, dose-escalation study designed~     to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered~     intravenously in patients with locally advanced or metastatic solid tumors that have~     progressed after all available standard therapy or for which standard therapy has proven to~     be ineffective or intolerable, or is considered inappropriate. The planned duration of the~     study is approximately 3 years.~   "
63991|NCT02219711|"~     MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit~     a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR,~     DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with~     advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism,~     pharmacodynamic and clinical activity profiles.~      During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the~     Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient~     populations.~      Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor~     type, including but not limited to, non small cell lung cancer and head and neck cancer~     positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR~     gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or~     NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients~     with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic~     prostate cancer with bone metastasis will be enrolled.~   "
63992|NCT02219698|"~     The purpose of this study is to determine the safety and efficacy of symptomatic treatment~     (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.~   "
63993|NCT02219685|"~     The primary objectives of this study are to evaluate the effect of sustained virologic~     response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)~     and on neurocognition as measured by neurocognitive tests. This study will also evaluate the~     antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose~     combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.~      During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF~     FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,~     participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12~     weeks.~   "
63994|NCT02219672|"~     This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection~     phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese~     patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii~     on HIV-1 reservoir.~   "
63995|NCT02219659|"~     A three-arm, randomized, pilot feasibility, study to assess the effect three validated~     sedation strategies on outcomes of patient on mechanical ventilation.~   "
64000|NCT02219594|"~     In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug~     eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions~     though it was about 3-5% in general. It is particularly important that in-stent restenosis~     after implantation was early diagnosed and detected. The evaluation of OCT imaging is more~     accurate for narrow area calculation, more clear for narrow organization structure and more~     specific for detecting tissue types.It is currently the best way for restenosis histologic~     diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive~     instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as~     the gold standard of stent restenosis.~      The improvement of spatial resolution of Gemstone CT can effectively improve the imaging~     quality and the measurement's accuracy of coronary artery stents.The diagnostic value of~     in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a~     certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.~      This study will examine the degree of in-stent restenosis by the gemstone CT and the~     320-detector row spiral CT and compare the two ways on the basis of the result of OCT.~   "
64001|NCT02219581|"~     The purpose of this study is to evaluate if the use of two small doses of intravenous (IV)~     steroids around the time of knee replacement surgery decrease a patient's pain or use of~     pain medication. The investigators will also determine if the subjects receiving the steroid~     will have better pain control and better postoperative outcomes after their surgery.~   "
64002|NCT02219568|"~     The purpose of this study is to compare the efficacy between video capsule endoscopy and CT~     enterography in diagnosis of obscure gastrointestinal bleeding.~   "
64003|NCT02219555|"~     We hypothesize that the ultrasound detectable variations in nerve, tendon and SSCT mobility~     in patients with CTS may be useful clinically, not to diagnose CTS, but instead as~     functional biomarkers that correlate with, and thereby serve as predictors for, treatment~     response. To test this hypothesis, we propose a longitudinal clinical study in which~     patients presenting for treatment of CTS will be monitored by ultrasound and by clinical~     assessment before and after non-surgical and surgical treatment. We will correlate the~     clinical outcomes with the initial ultrasound motion patterns that we have found to be most~     variable in CTS patients. We will also test the hypothesis that successful treatment results~     in a change towards normal in the affected ultrasound variables.~   "
64004|NCT02219542|"~     The investigators designed a study to determine whether with combined general-transversus~     abdominis plane block anesthesia or standard general anaesthetic would provide same level of~     cytokines in patients undergoing Laparoscopic Colonic Surgery.~   "
64005|NCT02219529|"~     A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's~     approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy~     of MCE with that of standard gastroscopy for gastric diseases in 70 patients with~     encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both~     the diffuse and focal diseases in stomach, we performed this single-blinded multi-center~     prospective study compared MCE with gastroscopy in patients with gastric symptoms and~     indication for upper GI Endoscopy.~   "
64006|NCT02219516|"~     This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)~     study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.~   "
64007|NCT02219503|"~     The purpose of this study was to evaluate the safety and efficacy of ombitasvir/~     paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus~     (HCV) infection and cirrhosis.~   "
64008|NCT02219490|"~     The purpose of this study is to evaluate Long-term outcomes following treatment with~     ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic~     Hepatitis C Virus (HCV) infection.~   "
64009|NCT02219477|"~     A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and~     Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir~     with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and~     Decompensated Cirrhosis.~   "
64010|NCT02219464|"~     The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal~     oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery~     under moderate sedation.~   "
64011|NCT02219451|"~     The purpose of this study is to verify the effects of exercise training on sympathetic~     modulation and arterial baroreflex control in patients with chronic heart failure.~   "
64012|NCT02219438|"~     Patients usually experience moderate-to-severe pain following the knee replacement that is~     often treated with a femoral nerve block (injection of numbing medicine placed around the~     main nerve of the knee joint). To make the nerve block last longer, a tiny tube is often~     placed next to the nerve and numbing medicine is infused for multiple days. However, while~     the numbing medicine takes away pain, it also decreases sensations, muscle strength, and~     proprioception (knowing where the leg is in space without looking at it) which greatly~     increases the risk of falling. Since falling can be catastrophic following major surgery, a~     femoral nerve blocks are being phased out by surgeons and anesthesiologists. The~     most-promising replacement is called an adductor canal nerve block. For this new type of~     block, a perineural catheter is inserted into a small canal in the middle of the upper leg.~     This canal contains the sensory nerve fibers leading to the knee, and only a single nerve~     that serves a relatively small muscle. Multiple studies have demonstrated a dramatic~     increase in muscle strength using the new adductor canal block compared with the traditional~     femoral block. However, practitioners perceptions of the new block is that it provides~     insufficient pain control following knee arthroplasty, even though all of the sensory nerves~     affected with the femoral block are also—theoretically—affected with the adductor canal~     block. One reason for this difference may be the small canal of the latter which is a~     relatively tight area in which the numbing medicine might not spread particularly well (due~     to pressure from surrounding tissues). One way to possibly counter this issue is by~     providing repeated boluses of the numbing medicine that will improve the medicine's spread~     relative to a more-traditional slow, continuous (basal) infusion. This study seeks to~     compare these two techniques of medication administration through perineural adductor canal~     catheters:~      Our primary aim is to test the hypothesis that, for continuous adductor canal blocks,~     providing local anesthetic as repeated, hourly bolus doses results in an increased sensory~     block compared with providing local anesthetic as a continuous basal infusion at an~     equivalent hourly dose.~      As a secondary aim, we hypothesize that, for continuous adductor canal blocks, providing~     local anesthetic as repeated, hourly bolus doses results in either equivalent or less motor~     block compared with providing local anesthetic as a continuous basal infusion at an~     equivalent hourly dose.~   "
64013|NCT02219425|"~     The aim of this study is to evaluate the gene expression of the endometrium after an~     endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.~   "
64022|NCT02219308|"~     Intrauterine device (IUD) placement can be painful for patients during and after the~     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly~     effective long acting reversible contraception. Currently there are no proven effective~     methods for reduction of pain during and after placement of modern IUDs. Paracervical block~     pain may decrease this placement pain.~   "
64014|NCT02219412|"~     This study was a feasibility trial that was designed to provide preliminary observations and~     generate hypotheses for future studies. The aim of the study is to estimate the difference~     of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and~     aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary~     artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet~     aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of~     aspirin/ticagrelor dual-therapy.~   "
64015|NCT02219399|"~     Supplementation with DHA during pregnancy will increase gestational length and improve~     cognitive development.~   "
64016|NCT02219386|"~     Deep dry needling of active myofascial trigger points of trapezius muscle is effective in~     the dimminution of pain of patients~   "
64017|NCT02219373|"~     Given the widespread use of anticonvulsants in the pediatric chronic pain population and the~     absence of scientific data supporting their use, the investigators propose a randomized,~     double blind, two group parallel design in which a broad group of children and adolescents~     with chronic neuropathic pain would be randomized to receive either Gabapentin or~     Oxcarbazepine.~      The Primary Aim of the Study is to assess the frequencies of successful treatment of~     pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.~      The Primary Hypotheses are as follows:~      Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain~     scores when compared to each patient's baseline.~      Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the~     second phase of the trial will report greater pain reduction relative to baseline than~     patients who are randomized onto placebo at this randomization point.~      Secondary Aims of the Study are to compare groups treated initially with Gabapentin or~     Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked~     maneuvers), functional disability scores, tolerability, and measures of mood and cognitive~     functioning.~      Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:~        1. Pain scores at rest and with evoked maneuvers~        2. Functional disability scores~        3. Tolerability (frequencies of side-effects)~        4. Depression and anxiety scales~        5. Neuropsychological measures of cognitive processing speed, working memory, and~          attention.~   "
64018|NCT02219360|"~     Chronic obstructive pulmonary disease has become a serious global health care and public~     health problems due to its high prevalence, high morbidity and heavy economic burden. Acute~     exacerbation of chronic obstructive pulmonary disease is one of the most important causes of~     death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD~     exacerbations. In clinical practice for the treatment of acute exacerbation of COPD，~     antibiotic application is still controversial. Evidence from current guideline is based on~     strict criteria from randomized controlled trials, thus the given condition is simplified.~     Patients meet the criteria account for the minority in the real world. Therefore, it is~     still not clear whether most patients benefit from the recommended treatment. In our design,~     hospitalized patients with acute exacerbation of COPD will be enrolled, with their~     treatment, arterial hypoxemia, recovery time and length of hospitalization being observed.~     The main purpose is to evaluate the benefit effect of current recommended treatment of acute~     exacerbation of COPD in the real world.~   "
64019|NCT02219347|"~     Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom~     population; it is an autoimmune disease where the body's natural defences (the immune~     system) attack the body itself resulting, most notably, in joint damage and arthritis. To~     help prevent this, patients with rheumatoid arthritis need to take disease-modifying~     anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug~     treatments are prescribed as long-term medications taken for many years.~      With successful drug treatment, many patients are able to achieve an excellent control of~     their disease and their arthritis can go in to remission. At present, there are no markers~     which can reliably predict which of these patients can reduce their drug treatment, and~     hence benefit from a lower risk of side effects and inconvenience, without an increase in~     their arthritis activity.~      We invite patients with stable rheumatoid arthritis to participate in this study conducted~     by Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle~     University and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being~     in remission will be able to stop their DMARD medication and be monitored for a period of 6~     months. Patients whose arthritis activity increases during this time will be able to restart~     their DMARD medication, whereas those patients whose arthritis remains in remission will be~     able to stay off DMARD medication.~      The main aim of this study is to identify clinical, ultrasound and blood markers that can~     predict which patients will remain in remission after stopping DMARD medication. If~     identified, these markers could be a useful guide to doctors and patients in the future when~     deciding whether to stop DMARD therapy.~   "
64020|NCT02219334|"~     The purpose of our study is to determine the safety, efficacy, length of stay and parental~     satisfaction of the NoseFrida in comparison to suction devices used in the hospital setting~     in patients with bronchiolitis in the Emergency Department Observation Unit (EDOU).~   "
64021|NCT02219321|"~     Prescription drug abuse represents a major healthcare problem, with treatment costs reaching~     billions of dollars annually in the United States alone. Today opioids are commonly~     prescribed for chronic non-cancer pain and are only partially effective for short-term pain~     relief. Whereas opioids are initially part of the solution for pain, it eventually often~     turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be~     complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity,~     hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory~     drugs is associated with a marked increase in adverse effects.~      The purpose of this study is to determine whether systemic administration of lidocaine~     provides effective pain relief in opioid dependent chronic pain patients. Investigators~     intend to demonstrate that lidocaine infusion can improve pain relief and physical function~     in opioid dependent patients, thus improving compliance and patient satisfaction, which may~     potentially help wean patients off narcotics. The long-term goal of this proposal is to~     decrease opioid dependence in chronic pain patients by using lidocaine infusion.~   "
65386|NCT02201498|"~     This is a RCT that will compare the clinical and radiographic success of pulpotomies on~     primary molars between the traditional technique (Formocresol/ZOE) and the new technique~     with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12~     months.~   "
64024|NCT02219282|"~     As a result of rises in living standards quality of life is progressively increasing.~     Combined with developments in anesthesia, surgical techniques and medication allowing more~     difficult and complicated interventions to be carried out, elderly patients are encountered~     more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric~     patients increases the possibility of airway obstruction. In old patients with no teeth,~     sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.~      In addition to our observations that Laryngeal mask (LM) is more difficult to place in older~     patients, in the literature there are very few studies on the use of LM in older patients.~     Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more~     difficult for patients without teeth compared to those with teeth. Laryngeal mask is an~     alternative airway device for patients without teeth when the face mask does not sit~     correctly.~      The aim of this study is primarily to measure the success of placement on first try, ease~     and duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in~     patients 65 years of age and above dentulous and edentulous elderly patients. The secondary~     aim is to compare the effects on the hemodynamic response occurring during placement.~   "
64025|NCT02219269|"~     The investigators will conduct a prospective observational cohort study to investigate~     factors that influence contraceptive method utilization among women with medical conditions.~     The investigators will also investigate how women with medical conditions access to~     contraception and family planning fellowship trained specialist. After the baseline~     questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate~     continuation and satisfaction with the contraceptive method. This study is unique because it~     will allow us to explore doing collaborative family planning research at the multiple UC~     medical campuses.~   "
64026|NCT02219256|"~     The purpose of this study is to characterize the pharmacokinetic and safety and tolerability~     profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous~     administration at escalating dose levels in healthy participants.~   "
64027|NCT02219243|"~     A substantial number of children with social anxiety fail to gain benefit from contemporary~     cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment~     of social anxiety are needed. The current study attempts to modify an interpretation style~     that is characteristic of children who also display high anxiety in social situations.~     Participants between the ages of 8-12 years old, with social anxiety, will be randomly~     assigned to one of three treatment conditions: two conditions are designed to manipulate the~     interpretation bias or a wait-list control condition. All study procedures will be conducted~     online. This study will help develop an effective cognitive intervention program for social~     anxiety in children.~   "
64028|NCT02219230|"~     The goals of this study are to assess measured, observed, and self-reported outcomes~     achieved through the use of passive (mechanical), active(motorized) and adaptive~     (magnetorheological) prosthetic knee control systems in individuals with unilateral,~     transfemoral amputation.~   "
64029|NCT02219217|"~     The purpose of the study is to look at the levels of three HIV medications: dolutegravir,~     elvitegravir and cobicistat in blood after the drug intake has been stopped in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs after taking them every day for 10 days dolutegravir on a~     first stage and a combination of elitegravir and cobicistat in a second stage.~      If the participant decides to take part, the duration of the study will be up to 38 days~     plus a screening visit which will take place up to 28 days prior to the start of the study,~     and a follow up visit which takes place 7 to 14 days after the last dose of study~     medication.~      This study is not randomised which means that all participants will receive all study~     medications in the same order. The participant and the study doctor will know which study~     medications the participant is taking at all times during the study.~   "
64030|NCT02219204|"~     Dry eye is a major, common medical condition with significant health and economic burden in~     Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and~     underlying systemic disease, inducing a significant decrease in quality-of-life. The~     hallmark of this disease is raised tear osmolarity and inflammation. There is no definitive~     cure for this condition, as treatment in the form of lubricants is only symptomatic and~     treatment with cyclosporine eyedrops is expensive and may not be well tolerated.~      Following the rise in international interest in complementary medicine,~     randomized-controlled studies in dry eye using Traditional Chinese Medicine (TCM) have been~     published, with mixed results. However, the major limitation of these studies is the lack of~     objective assessment for inflammation.~      We propose to collaborate with an academically-trained Singapore TCM physician who has~     conducted dry eye trials, and synergistically exploit the existing state-of-the-art dry eye~     monitoring technologies available at Singapore Eye Research Institute (SERI). This proposal~     is cost-effective, building on previous government grants and expertise to provide~     definitive scientific evidence on the efficacy and safety of TCM in dry eye. SERI has an~     international reputation for interventional studies, and the PI has a good academic~     relationship with the above TCM physician. We propose to screen, recruit and treat 150~     patients with a herbal preparation and acupuncture, and evaluate over 4 weeks in a~     randomized-controlled study. Tests to be performed will include tear imaging and osmolarity,~     as well as protein and cytokine assays.~      Singapore is uniquely positioned at the crossroads of the East and the West to take the lead~     in this field. Given that there is an increasing patient interest in holistic care in~     Singapore and the rise of scientifically trained TCM practitioners, a study like this one is~     very timely, and will have tremendous impact to healthcare delivery in Singapore.~   "
64031|NCT02219191|"~     To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in~     patients with chronic rheumatic diseases~   "
64032|NCT02219178|"~     This study aims to evaluate the overall response rate after 4 cycles and the best response~     to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and~     dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.~   "
64033|NCT02219165|"~     Staphylococcus aureus and Streptococcus pyogenes produce many virulence factors. Some of~     them are responsible for severe infections in humans. Superantigen toxins synthesized by S.~     aureus or by S. pyogenes, are responsible for toxic shock syndromes (TSS) which lethality~     can attain 25% in children with validated criteria of septic shock.~      Previous studies, performed in vitro and in vivo in animals, have shown that Intravenous~     immunoglobulins [IVIG] contain antibodies [Ab] against these toxins and, when used at high~     concentration, IVIG are able to neutralize their toxicity. However, in all these studies,~     IVIG administration has been preventive and there is no reliable data demonstrating their~     therapeutic efficacy in vitro or in vivo in humans or in animals, once the disease is~     present.~      The efficacy of IVIG is established in other pathologies for which the role of the~     superantigens [superAg] is suspected, like Kawasaki disease in children. The mechanism of~     action, although not perfectly known, involves at the same time a direct effect on superAg~     (Ag-Ab complex) and indirect effects like the neutralisation of superAg within the network~     of anti-idiotype Ab or the neutralisation of the T-cells receptors. Staphylococcal and~     streptococcal toxic shocks imply bacterial exotoxins that are superAg. It seems thus~     consistent to imagine a same type of treatment with IVIG. However, there is currently no~     evidence of the efficacy of IVIG in this indication. One of the explanations relies on the~     lack of statistical power of previous adult studies, which principal objective was to show a~     reduction of the mortality. Taking into account the low prevalence of TSS, it has been hard~     to recruit enough patients to have the required statistical power. Moreover, some works have~     been extracted from larger studies on septic shock and the definitions of the TSS were nor~     always very reliable. Lastly, if the investigators consider the definition of the TSS as~     mentioned by the  Centre for Disease Control  [CDC], for which any hypotension, even a~     simple orthostatic hypotension, serves the diagnosis of TSS as long as the other symptoms~     are present, it is obvious that many patients are likely to be recruited in a study although~     it is highly probable that their health will get better with a  standard  treatment. The~     definition of a  real  TSS can be refined, keeping the CDC criteria, but changing the~     hypotension criterion in a more accurate criterion as described in the  surviving sepsis~     campaign , internationally accepted and based on norms adapted to the age for paediatric~     forms.~      IVIG therapy is very expensive and TSS is not recognized as indication of IVIG according to~     their marketing authorization. The feasibility of a randomized controlled study with this~     treatment needs to be assessed as it would be hazardous to conduct a large prospective RCT~     without having first assessed this feasibility in terms of recruitment rates, consent rates~     or compliance rates. Inclusion, randomisation and collect of inform consent in the context~     of severe shock are challenging and require evaluation of feasibility. The sample size~     calculation of the large study on mortality required estimations of the event in the~     specific population of children with criteria of septic shock. Surrogates markers of outcome~     need to be better defined. For example it would be useful to determine the evolution of~     organ dysfunctions with and without IVIG treatment in this population.~      Various organ failure scores, used upon admission and later on, have been validated in~     adults and in children. The absence of improvement of the Paediatric logistic organ~     dysfunction (Pelod) score over time is a good indicator of mortality in Paediatric intensive~     care unit (PICU). It could be used as surrogate marker to evaluate the efficacy of IVIG.~   "
64034|NCT02219152|"~     Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.~      Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial~     amount of bleeding that requires a special treatment or follow up.~      The goal of this study is to examine whether submission of tranexamic acid during the biopsy~     could diminish the amount of bleeding.~   "
64035|NCT02219139|"~     Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions~     on modified surface abutments compared to machined surface abutments.~   "
64036|NCT02219126|"~     This study aims to investigate differences in digestion rates and stomach problems caused by~     pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible~     capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol~     levels and plasma cytokine levels.~   "
64037|NCT02219113|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm~     study with no control. All patients receive cell therapy.~   "
64038|NCT02219100|"~     This study examined the acceptability and feasibility of using a simplified regimen of~     medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of~     mifepristone and misoprostol, and buccal administration of misoprostol, would be both~     acceptable to women and efficacious.~   "
64039|NCT02219087|"~     The purpose of this study is to determine whether liposomal bupivacaine is effective in the~     management of pain following total knee arthroplasty, as compared to standard of care~     analgesia.~   "
64040|NCT02219074|"~     Prospective, multicenter study with multiple arms to examine the safety and effectiveness of~     the Sebacia Acne Treatment System for the treatment of acne vulgaris.~   "
64041|NCT02219061|"~     Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.~        -  Geometric mean titers(GMTs) of measles and meningitis C.~        -  Follow-up on 0 month, 3rd month,5th month and 7th month after birth.~   "
64042|NCT02219048|"~     The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe~     asthma when added to standard of care and during staged withdrawal of background therapy.~   "
64043|NCT02219035|"~     In patients presenting with acute stroke or transient ischaemic attacks (TIA), von~     Willebrand factor related parameters, including VWF antigen, activity, FVIII:c and~     propeptides, ADAMTS13 levels and VWF multimers in cases where ADAMTS 13 was reduced will be~     measured. Global haemostasis will be assessed using thrombin generation and the relation~     between increase thrombin generation and VWF explored. Thrombin generation will be performed~     pre and post filtration for the presence of procoagulant microparticles. These parameters~     will be investigated acutely, at presentation and in convalescence; in addition, the effect~     on these parameters of treatment such as thrombolysis may be informative. Correlation~     between measured parameters and adverse clinical outcome would be used to identify markers~     of severity and progression of ischaemic stroke and identification of potential novel~     approaches to therapy that might improve outcome.~   "
64044|NCT02219022|"~     A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients~     will be randomized into two groups. Experimental group will do a 12 weeks training of~     progressive resistance exercise for global muscles and remain with the clinical treatment~     and the control only remain with the clinical treatment. Patients will be evaluated at~     baseline, after 6, 12 and 24 weeks.~   "
64045|NCT02219009|"~     The purpose of this study is to determine the usability of the Medical Information Device #1~     (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.~   "
64046|NCT02218996|"~     The purpose of this study is to examine the content of the treatment being delivered for~     anxiety disorders for children and adolescents in the regular outpatient clinics in western~     Norway. The study will also collect data before and after treatment to evaluate the result~     of the treatment. Furthermore, as part of the study we aim to collect normative data on two~     questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere~     with daily functioning. We also aim to develop a quality indicator for anxiety treatment~     that can be used to monitor treatment in the regular outpatient service, based on the~     results of the current study.~   "
64047|NCT02218983|"~     Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in~     critical care. First introduced for volume assessment in nephrology and cardiology, it is~     now being researched in emergency and critical care. Data is still evolving in its use in~     initial trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in~     trauma, but utility of its measurement on U/S in the emergency department still has some~     controversy. In trauma specifically, small studies suggests benefit to the use of U/S to~     predict volume status, and most of these data are from one author. It is not known if this~     can be applied more broadly. The prognostic value of findings on limited transthoracic~     echocardiogram (LTTE, SonoSite Ultrasound) has been studied in several small studies, and~     only one small randomized controlled trial has proven benefit to its use. Due to inter-rater~     reliability and the fact that all reports on credentialing of thoracic ultrasound use in the~     trauma bay are from one group, it is not known if it can be applied to all trauma~     populations.~      Research question:~      Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit~     (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as~     well as or better than other methods of organ perfusion?~      Hypotheses:~        1. Use of LTTE is associated with improved outcomes (less organ failure, decreased~          hospital and ICU stays, transfusions, and mortality).~        2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on~          ventilator, number of and transfusions better than other methods of organ perfusion~          (tachycardia, hypotension, lactate, lactate clearance, creatinine, base deficit).~   "
64048|NCT02218970|"~     Physical health does not have a high priority in today's treatment of patients with~     substance use disorder (SUD). SUD patients have a poor physical health not only due to~     injuries related to the substance abuse, but also because of the addiction-related~     lifestyle. There are few studies today that provide information about SUD patient's physical~     health, and especially there is little information about their muscular strength. One of the~     project's aims is to measure muscular strength in SUD patients who are being treated for~     their addiction, and see if they have decreased neuromuscular function. If so, we will~     investigate the effect of maximal strength training on neuromuscular function in these~     patients.~   "
64080|NCT02218554|"~     To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the~     BRONJ Assay) in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for~     developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous~     (IV) administration of Bisphosphonates (BP).~   "
64095|NCT02218346|"~     AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small~     molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer~     treatment.~      Administration of oral drugs with food may change the absorption of drugs, and it is~     therefore useful to characterize the effect of food early in drug development.~   "
64049|NCT02218957|"~     Morbid obesity is an increasing medical problem in the western countries. It's related to~     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.~     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese~     patients. A part of these patients will have disappointing results, and have weight regain~     on the long term. Some studies show more weight reduction by increasing the biliopancreatic~     limb in patients with morbid obesity.~      The objective of this study is to investigate the effect of a restrictive/extended pouch on~     weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the~     restrictive/extended pouch results in more weight reduction.~      The study design is a prospective, randomized control trial. The patients will be randomized~     in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.~   "
64050|NCT02218944|"~     The current study tests a response inhibition retraining program, implemented on a mobile~     device, as a mechanism to increase relapse prevention during a smoking cessation attempt.~     Study participants (n = 150) are randomly assigned to a control, benign, or intervention~     condition. They complete 2 weeks of response inhibition retraining, and then engage in a~     cessation attempt. It is hypothesized that individuals who receive the intervention will~     have a decreased likelihood of relapse following the cessation attempt. In addition, it is~     hypothesized that this is due to decreases in implicit smoking motivation as a function of~     the response inhibition training.~   "
64051|NCT02218931|"~     Obesity is a growing problem in East London and every other woman who enters pregnancy is~     obese or overweight. In addition to obesity, other metabolic risk factors such as raised~     lipids, high blood pressure and diabetes increase pregnancy related complications such as~     preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia,~     presenting as hypertension and proteinuria is a leading cause of maternal and fetal~     mortality and morbidity. Interventions that reduce cardiovascular events by modifying risk~     factors also have the potential to reduce the risk of preeclampsia. The investigators work~     funded by the National Institute of Health Research (NIHR) in the UK showed that dietary~     interventions in obese pregnant women may reduce the risk of preeclampsia. The investigators~     propose to show that pregnant women with metabolic risk factors derive the most benefit from~     a simple, targeted intervention based on Mediterranean dietary pattern to reduce the risk of~     maternal and fetal complications . Women with the risk factors (1230 women) will be randomly~     allocated to dietary intervention or usual antenatal dietary advice and the risk of maternal~     and fetal complications will be evaluated. The remaining eligible women who are consented~     for lipid tests, but do not have metabolic risk factors, will be followed up for outcome~     data only. Diet based interventions, especially those based on a Mediterranean dietary~     pattern has a potential to reduce the risk of preeclampsia. In the investigators study,~     pregnant mothers with risk factors will be randomly allocated to either a dietary invention~     or usual antenatal care and they will assess their composite maternal (pre-eclampsia or~     gestational diabetes) and fetal (stillbirth, small for gestational age or admission to~     neonatal intensive care unit) outcomes. The investigators will tailor the intervention to~     suit the individual needs of the mother and provide nuts and olive oil to improve~     compliance. The study will be undertaken across the three maternity units at Barts Health~     NHS Trust, which delivers 17,000 women/year and two other maternity units in England. The~     study is supported by the office of the Mayor of Tower Hamlets which will facilitate the~     involvement of grassroots workers to promote recruitment and uptake of the intervention.~   "
64052|NCT02218918|"~     Pulmonary Rehabilitation became a vital part of management in COPD patients in form of~     activity modification, dietary and pharmacological optimisation. But access to traditional~     supervised aerobic (treadmill) walking is debatable fact due to economical and staffing~     expertise in developing countries like India. The investigators designed a randomised~     controlled trial to evaluate the effectiveness of ground based walking over traditional~     treadmill walking in improving quality of life in COPD patients.~   "
64053|NCT02218905|"~     This study is to find relation between number of repetitions the volunteer able to sit and~     stand in an armless chair and their age, height, weight and gender. The investigators~     hypothesis there is a moderate relation between anthropometric characteristics and number of~     situps. This may partially define the ability of functional capacity and quadriceps ability.~   "
64054|NCT02218892|"~     Purpose and aims The general aim of this project is to improve the diagnostic methods for~     disease activity and identify predictive factors (clinical and radiographic factors, pro-~     and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ)~     involvement in juvenile idiopathic arthritis (JIA).~      The hypothesis is that self-reported pain and impaired jaw function together with clinical~     findings correlates well with radiological signs of jaw involvement.~      Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not~     correlate with radiological signs of jaw involvement.~      Study 1 The aim of this study is to investigate which findings from the patient history and~     from clinical examination that is of significance for diagnostics of TMJ involvement in~     patients with JIA both in a short- and long-term perspective. The patients will be~     followed-up during two years. They will undergo a clinical examination according to Research~     Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992)~     once a year and a telephone follow-up sixth months after the clinical examination. Further,~     the clinical findings from the orofacial regions will be compared to their general disease~     activity.~      Study 2 The aim of the second study is to correlate radiological findings and clinical~     findings in order to investigate any early radiological signs of disease activity and~     progression but also to compare the radiographic examination using conventional panoramic~     technique with computer tomography (CT).~   "
64055|NCT02218879|"~     The primary objective is to directly estimate brain glutathione concentrations in vivo using~     H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)~     patients considering switching therapy or being treatment-naive (first line).~   "
64056|NCT02218866|"~     The goal of this research is understand if obesity is a major factor for neuropathy~     development in patients with and without Type 2 diabetes. This study will examine the~     relationship between weight, metabolism, and nerve function and regeneration.~   "
64057|NCT02218853|"~     The objective of this multi-site research collaboration is to test the manifestation and~     distribution of biological markers for psychosis and affect dimensions across the~     schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic~     associations for these biological markers.~   "
64093|NCT02218372|"~     The purpose of this study is to investigate the clinical response to fidaxomicin oral~     suspension or tablets and vancomycin oral liquid or capsules in pediatric subjects with~     Clostridium difficile-associated diarrhea (CDAD). It will also investigate the~     recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well~     as acceptance of the fidaxomicin oral suspension formulation.~   "
64094|NCT02218359|"~     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin~     Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with~     Gram-negative and / or Gram-positive bacterial colonization.~   "
64058|NCT02218840|"~     Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This~     study will be evaluating the behaviors of cigar smokers and the short term effects of cigar~     smoking.~      A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are~     small cigars with filters that resemble cigarettes and large cigars that do not have~     filters. Because cigars come in so many shapes and sizes, the nicotine content varies as~     well. The way that a cigar smoker consumes the cigar can also have an effect on how much~     nicotine is absorbed. This study seeks to understand nicotine consumption and addiction in~     cigar smokers.~      Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your~     visits may include a physical exam, medical history review, questionnaires, blood~     collections, providing a urine sample, an exhaled breath test, having your vital signs~     collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we~     can review the technique you use while smoking.~      STUDY HYPOTHESES:~        -  Significant reductions in craving and withdrawal will be reported after ad libitum~          smoking of a cigar compared to self-report prior to cigar smoking.~        -  Cigar smokers will show a range of nicotine dependence, with a subset of users~          exceeding minimal criteria for nicotine dependence.~        -  Levels of nicotine, cotinine, Carbon Monoxide (CO), and~          4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from~          pre- to post-cigar smoking.~        -  Small cigar/cigarillo users will demonstrate greater levels of dependence and greater~          relief from craving and withdrawal compared to large cigar users.~   "
64059|NCT02218827|"~     Many patients refer to an oculoplastic or corneal clinic examination due to dry eye~     symptoms. epidemiologic studies estimate that as many as 15% of the population over 60 years~     suffer from dry eye. the disease can be treated both topically through several drugs or~     through mechanical closure of the lacrimal drainage system. in the past decade a few studies~     demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the~     inflammatory process that occurs in it. this treatment rises goblet cell counts but in the~     meantime elevates the intra ocular pressure and elevates the risk for infections. steroids~     that cause a lower increase in intraocular pressure have not been thoroughly evaluated in~     dry eye disease. we with to subjectively and objectively evaluate an FDA approved topical~     steroidal drug in the treatment of dry eye.~   "
64060|NCT02218814|"~     The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty~     who receive a single shot Adductor Canal nerve block and local infiltration will have~     improved functional outcomes compared to individuals who receive a femoral nerve block and~     local infiltration during the first 24 hours post surgery.~   "
64061|NCT02218801|"~     This prospective database has two main objectives;~        -  to evaluate the complication rates, 30-day and 90-day mortality from different surgical~          strategies for unresectable, borderline resectable or initially unresectable liver~          metastasis from colorectal cancer.~        -  to establish baseline quality parameters for different surgical strategies for~          unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM)~          patients.~   "
64062|NCT02218788|"~     The purpose of this study is to assess the safety and performance of Hydroxytite in all~     subjects who have received sub dermal or deep dermal injections.~   "
64063|NCT02218775|"~     The available treatments for patients with mood and anxiety spectrum disorders have~     significant limitations. This study will contribute significantly to public health by taking~     steps to address these limitations by aiding in the interpretation of a study that: 1) tests~     a promising new treatment for mood and anxiety spectrum disorders; 2) evaluates a potential~     target in the brain which could serve as the basis for development of additional new~     candidate compounds for the treatment of patients with mood and anxiety spectrum disorders;~     3) establishes more expeditious methods for evaluating potential new therapies for patients~     with mood and anxiety spectrum disorders; and 4) specifically establishes methods for the~     development of new therapies targeting anhedonia, an important RDoC (Research Domain~     Criteria) endpoint.~   "
64064|NCT02218762|"~     The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg)~     twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and~     licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the~     ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic~     patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment,~     four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild~     to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone~     proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58~     subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject~     will be allocated to one of two treatment sequences and will participate in four treatment~     periods, receiving each of the treatments twice.~      DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of~     companies.~   "
64065|NCT02218749|"~     The purpose of this study is to determine whether initial triaging to physiotherapists of~     patients with musculoskeletal disorders who seek health care from primary care clinics~     affects the patients health and/or health care utilization differently than initial~     consultation with a general practitioner.~   "
64078|NCT02218580|"~     While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no~     cure. Despite receiving standard of care, many children live with pain. Thus, it is not~     surprising that families turn to complementary and alternative medicines (CAM) therapies,~     including massage therapy (MT). Little is known about the efficacy of MT in JIA.~      In this project, a massage therapist will teach parents how to provide a massage to their~     child with JIA at bedtime, at home. The feasibility of establishing a home MT program for~     children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.~      This proposal is relevant to JIA families, who ask questions on MT to professionals of the~     JIA clinic.~      Beyond providing education to JIA families, this project demonstrates the team approach to~     JIA management. Team members will include a pediatric rheumatology nurse and a massage~     therapist.~   "
64079|NCT02218567|"~     The study hypothesis is that caregivers experience allows them to develop a lot of knowledge~     and know-how about behavioural problems in Huntington Disease and its consequences. The~     purpose of this study is to collect, describe and analyse caregivers experience in order to~     find and enhance their knowledge related to the adaptation to behavioural problems of~     Huntington Disease patients.~   "
64066|NCT02218736|"~     The available treatment for patients with mood and anxiety disorders have significant~     limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments~     for people with these disorders. Many research studies carried out in animals and a few~     preliminary studies carried out in humans suggest that medications which block kappa opioid~     receptors (KOR) have potential for being effective new treatments for patients with mood and~     anxiety spectrum disorders. These medications have shown particular promise for improving~     one important type of difficulty experienced by many patients who suffer from mood and~     anxiety spectrum disorders referred to as anhedonia, which is an impairment in~     reward-related function. In this study we will test the hypothesis that KOR antagonism is a~     promising means of improving anhedonia in patients with mood and anxiety spectrum disorders.~     We will do so by evaluating whether we can establish Proof of Concept (POC) that a~     relatively selective KOR antagonist, CERC-501 (formerly known as LY2456302), engages neural~     circuits involved in mediating reward-related function in patients with mood and anxiety~     spectrum disorders with anhedonia. We are attempting to establish POC in this study in order~     to determine whether there is a sufficient basis for pursuing future work evaluating whether~     KOR antagonism has therapeutic effects on clinical and behavioral measures of reward-related~     functioning.~   "
64067|NCT02218723|"~     This is an open-label, five- period, cross-over, randomized, single dose, single centre~     study in healthy subjects. This is the second clinical study for the UD-DPI. This study will~     ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the~     plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of~     FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the~     ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three~     dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This~     study is designed to compare the pharmacokinetic profile of various doses and blends of FF~     administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be~     screened 28 days prior to study initiation. During each treatment period, subjects will be~     at study site from evening prior to dosing until completion of the 48 hour post-dose PK~     sample collection on Day 3. Minimum 7 days washout will be between treatments after~     completion of all five treatments and the follow-up visit will be conducted 7-14 days post~     last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group~     of companies.~   "
64068|NCT02218710|"~     The aim of the study is to assess bone geometry, bone compartment specific volumetric~     densities and micro-architecture as well as to evaluate non-invasive estimates of bone~     strength in patients with adult onset growth hormone deficiency.~   "
64069|NCT02218697|"~     The purpose of this study is to investigate the immunogenicity and safety when GSK~     Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with~     Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age~     and older at risk for complications from influenza and pneumococcal infections.~   "
64070|NCT02218684|"~     The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg~     telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.~   "
64071|NCT02218671|"~     Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE~     941 OD tablets are administered in Japanese healthy male volunteers.~   "
64072|NCT02218658|"~     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken~     without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was~     evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)~   "
64073|NCT02218645|"~     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and~     brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated~     in healthy adult male subjects.~   "
64074|NCT02218632|"~     Galactosaemia is an inherited condition caused by a lack of an enzyme (catalyst) which~     normally breaks down galactose (the sugar found in milk products). This affects 1:19,000~     births annually in Ireland (the highest incidence worldwide) and is screened for by the~     National Newborn Screening Programme. When an affected infant is diagnosed, galactose is~     immediately restricted from the diet. This prevents often fatal liver disease and other~     immediate complications. However, despite early treatment the majority of affected patients~     go on to develop long-term complications such as intellectual impairment, neurological~     complications, speech difficulties and infertility in females. The underlying mechanisms for~     these complications are unclear. The investigators have shown in detailed biochemical and~     gene analysis studies that major abnormalities affecting the function of complex molecules~     in the body, particularly glycoproteins, (consisting of sugar chains attached to proteins)~     persist in treated individuals which may lead to disturbances of the body's intrinsic~     cellular machinery and relate to the complications seen.~      In this research the investigators expand on from their earlier studies to see if they can~     identify biomarkers and parts of the galactose/glycosylation pathways which could be~     modified or changed with new treatments to improve outcomes for this condition (i.e., IgG N~     glycans).~      In more detail, the investigators test the use of the most abundant glycoprotein in human~     plasma (IgG) as an improved clinical test for monitoring the galactose control needed in~     patients and also to see if some patients (including children aged 5-12 yrs) might have a~     better predicted outcome with moderate increases of galactose in the diet. The investigators~     believe that these studies greatly improve the understanding of Galactosaemia with a view to~     improving current treatment options and future outcomes.~   "
64075|NCT02218619|"~     Clinically, the ability to slow or prevent beta cell demise can prevent or improve the~     course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent~     major pathological basis for the disease, has led to efforts to prevent or suppress this~     immune assault. Here we propose to buttress the beta cell's capacity to withstand this~     assault by improving the function of the endoplasmic reticulum stress resolving mechanisms~     within these cells. The ability to do so could have a major impact on preventive and~     therapeutic strategies for type 1 diabetes (and possibly other types of diabetes). The type~     of endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be~     applied on an anticipatory basis to individuals at high risk for type 1 diabetes.~   "
64076|NCT02218606|"~     The purpose of this study is to see what effects (good and bad) treatment with abiraterone~     acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a~     chemotherapy) have on the cancer and to find out more about whether specific laboratory~     tests on tumor are useful in predicting how the patient will respond to treatment.~   "
64077|NCT02218593|"~     This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for~     children who are using the WREX, or have used it in the past. The survey consists of a set~     of questions a) performed online and b) performed over the phone.~   "
64081|NCT02218541|"~     The study will involve placing a dental implant through a guided surgery protocol developed~     using 3D CT technology. Because the implant position is planned digitally using the CT data~     from the patient, this allows investigation of an abutment that supports the implant crown~     and soft tissues to be fabricated prior to implant placement. In doing so, this makes the~     protocol for patient care simpler and faster. In fabricating the the abutment prior to~     surgery, the investigators will design the abutments at different heights below the gumline~     to see an optimal margin height for fabrication of the abutment prior to surgery. The study~     hypothesis is that more often the abutment margin placed just slightly below (.5mm) the~     gumline will be visible about half of the time while the abutment margin placed further~     under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is~     that at delivery and follow-up, the abutment margin will not show intraorally.~   "
64082|NCT02218528|"~     The study is designed to determine the extent to which a plant-based ingredient is able to~     modulate blood glucose response when administered with a meal.~   "
64083|NCT02218515|"~     The present study aimed to evaluate the effects of enamel matrix derivatives either alone or~     combined with autogenous bone graft applied to intrabony defects in chronic periodontitis~     patients on clinical/radiographic parameters and gingival crevicular fluid transforming~     growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test~     whether the use of autogenous bone graft and enamel matrix derivative combination in the~     treatment of intrabony periodontal defects enhance the clinical, radiographic and~     biochemical parameters in comparison to the use of open flap debridement alone.~   "
64084|NCT02218502|"~     This study is performed to compare the diagnostic performance and cost-effectiveness of~     different diagnostic methods for differentiating benign from malignant adnexal (ovary or~     Fallopian tube) masses: the Risk of Malignancy Index (RMI) will be compared with a two-step~     triage test called simple ultrasound-based rules supplemented -if necessary- with either~     subjective assessment by an expert sonographer or Diffusion Weighted - Magnetic Resonance~     Imaging (DW-MRI). The investigators will test the hypothesis that this two-step triage test~     will have better diagnostic accuracy than the RMI and therefore will improve the management~     of women with adnexal masses.~   "
64085|NCT02218489|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121~     ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of~     inflammatory meibomian gland disease.~   "
64086|NCT02218476|"~     The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be~     randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn~     at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified~     leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes~     operated on various prothrombotic/proinflammatory parameters and their associated~     intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity;~     mitochondrial antioxidant system characterization; Expression levels and activity of~     transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2),~     Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs~     microarrays, RT-PCR validation and correlation/association studies. 6) Induction of~     over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.~   "
64087|NCT02218463|"~     First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.~     This study aims to evaluate an alternative and less costly option of treatment with~     potentially less side effects.~      Primary Hypothesis:~      There will be a difference in complete resolution of labial adhesions with topical estrogen~     with lateral traction as compared to an emollient with lateral traction.~   "
64088|NCT02218437|"~     Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow~     and takes part in the bone marrow microenvironment. The response rate of early treatment on~     Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG~     treatment) is associated with long-term effect. The injection of Umbilical Cord Derived~     Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.~   "
64089|NCT02218424|"~     This study is a double-blind randomized controlled trial using intravenous magnesium versus~     placebo to determine if systemic magnesium can decrease postoperative pain in pediatric~     patients undergoing tonsillectomy.~      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg~     bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume~     of normal saline bolus followed by infusion (placebo).~      The primary objective is to determine if systemic magnesium will decrease postoperative pain~     in patients undergoing tonsillectomy. The secondary objectives will determine if systemic~     magnesium administration is associated with a decrease in opioid-related side effects,~     decrease the incidence of emergence delirium, and improve postoperative functional recovery.~      The study hypothesis is that the use of intravenous magnesium will decrease postoperative~     pain, decrease opioid-related side effects, decrease the incidence of emergence delirium,~     and improve functional recovery in patients undergoing tonsillectomy.~   "
64090|NCT02218411|"~     The purpose of this study was to evaluate the effects of a video-supported group-based Otago~     exercise programme intervention on balance, mobility, physical performance and aerobic~     endurance in community-dwelling older adults 65+ years old.~   "
64091|NCT02218398|"~     Investigators developed a test to assess the bronchodilator effects in mechanically~     ventilated chronic obstructive pulmonary disease patients by comparing the change of airway~     resistance. No matter whether patients respond to bronchodilator or not, they are randomized~     assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then~     investigators could objectively decide whether individual patients need or benefit from~     bronchodilator administration.~   "
64092|NCT02218385|"~     The purpose of this study is to measure the performance characteristics for the collection,~     fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the~     ForeCYTE Breast Aspirator across 3 independent labs and the National Reference Laboratory~     for Breast Health (NRLBH). The study hypothesis is that each lab will have a specimen~     acceptability rate of at least 90%. If it is assumed that the true level of acceptability~     testing is approximately 96%, then the lower bound of a one-sided 95% confidence interval is~     expected to be at least 90%.~   "
64097|NCT02218320|"~     This is a Phase IV, open label, observational study to compare the gastrointestinal tissue~     concentrations, inflammatory response, and viral replication of two integrase-inhibitors,~     raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in~     blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled~     equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral~     regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10~     subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir.~     Participants will provide small pieces of tissue, or biopsies, which will be taken from~     three distinct locations of the large intestine during a colonoscopy procedure. These~     biopsies will be used to measure the amount of raltegravir or dolutegravir, HIV virus, and~     inflammatory markers present in the gastrointestinal tract.~   "
64098|NCT02218307|"~     Double blind placebo controlled trial to evaluate whether the routine use of nasal~     irrigation with mupirocin is more effective than saline irrigations alone in reducing~     symptoms of chronic rhinosinusitis in the early postoperative period.~   "
64099|NCT02218294|"~     The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by~     mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made~     by the body, the chemical composition of these metabolites and their profile over time in~     blood and urine will be determined.~   "
64100|NCT02218281|"~     The recent Surgeon General's Report calls for effective and readily available treatment~     approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for~     connecting adolescent smokers with smoking cessation assistance. This study will adapt the~     Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking~     cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps~     teens stop smoking compared to another teen smoking cessation app that does not include~     mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen~     would be relatively easy to disseminate widely and have tremendous public health~     significance~   "
64101|NCT02218268|"~     Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of~     65 children with Type I diabetes mellitus. This prospective, crossover study will help~     determine if there is an acute increase in arterial stiffness in children with Type I~     diabetes mellitus who do not give extra insulin to cover a meal. This will give more support~     to show why it is so critical to bolus every time they eat and to bolus on time to decrease~     cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving~     insulin before a meal compared to not giving insulin before a meal will be associated with~     lower arterial stiffness in children with type I diabetes.~   "
64102|NCT02218255|"~     The purpose of this clinical investigation is to gather pilot data to evaluate the impact of~     using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on~     clinical pregnancy rates.~   "
64103|NCT02218242|"~     All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will~     receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph~     node dissection. After completion of the standard of care, intraoperative ultrasound will be~     used to evaluate lymph node stations for the presence of any missed lymph nodes with~     particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data~     will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of~     ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is~     hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted~     thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes~     in non-small cell lung cancer patients undergoing definitive surgical resection.~   "
64104|NCT02218229|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral~     nerve. The purpose of this study was to assess the effect of extracorporeal shock wave~     therapy on carpal tunnel syndrome.~   "
64105|NCT02218216|"~     This hypothesis-generating feasibility study to determine potential associations between a~     broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and~     clinical findings involved in mild traumatic brain injury (mTBI). These associations will be~     examined over the acute and sub-acute period (baseline to 3 months) following injury to~     provide information useful for optimization of MR pulse sequences for mTBI applications.~      The intent of this study is to broadly generate a range of potential mTBI biomarkers~     detectable using investigational MR pulse sequence technologies. Feasibility data attained~     in this study may be used for engineering program decision-making and in support of future~     scientific assessment, engineering development, published research databases or registries~     mTBI data and images, and other purposes determined by the Sponsor. The results of this~     study are not intended for use in regulatory submissions.~      Subjects will be examined on commercially available MR scanner using investigational or~     standard of care MR coils and a series of investigational Application Packs containing a~     predetermined set of MR pulse sequences optimized by Sponsor~   "
64106|NCT02218203|"~     This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was~     part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple~     dose-combinations of chronic oral (PO)dextromethorphan and intravenous (IV) lidocaine in~     central neuropathic pain following spinal cord injury.~   "
64107|NCT02218190|"~     The purpose of the study is to determine with Alvimopan reduces the incidence of post~     operative ileus in patients who undergo posterior spinal fusion.~   "
64108|NCT02218177|"~     The purpose of this study is to evaluate the level of cytokines (which are small proteins~     important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related~     macular degeneration patients who have been treated with an injection in the eye~     (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be~     compared between patients who have a good response to ranibizumab treatment and patients who~     are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help~     for the future treatment and to potentially develop new medication for wet age-related~     macular degeneration.~   "
64145|NCT02217696|"~     The long-term goal of this study is to improve prediction of poor reading outcome at~     preschool age by using a combination of behavioural and neuroimaging measures and to~     evaluate a specific computerized training program to support children with problems during~     reading acquisition.~   "
64109|NCT02218164|"~     The purpose of this study is to find out if the combination of two established anti-cancer~     therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically,~     investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and~     Interferon alpha-2b (injection) can help people with advanced cases of squamous cell~     carcinoma of the skin. For participants that are not approved for oral capecitabine,~     treating physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon~     alpha-2b have been used separately to treat squamous cell carcinoma of the skin and are FDA~     approved in other cancer types.~   "
64110|NCT02218151|"~     Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of~     malignant and non-malignant diseases. However, it is associated with significant morbidity,~     and treatment-related mortality. This is due in large part to the prolonged pancytopenia and~     immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation~     and the wait until engraftment of the transplanted hematopoietic stem cells. During this~     vulnerable period, infectious complications are common. Historically HCT patients were kept~     in protected environments to safeguard their health during the pancytopenic phase; despite~     these measures, infectious complications and graft versus host disease (GVHD) remained~     common and lead to significant morbidity and mortality after HCT. Currently patients are~     still closely watched in the inpatient or day hospital environment, though recent practices~     allow patients more freedom. This study randomizes eligible patients to receive~     post-transplant care at home vs. in the hospital or clinic, per standard of care. The~     primary objective is to compare the incidence of grade II-IV acute GVHD at 6 months in~     patients receiving patient-centered medical home (PCMH) vs standard care.~   "
64111|NCT02218138|"~     Type 2 diabetes is a chronic disease that puts people at risk for major health problems like~     heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there~     has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through~     poor insulin sensitivity, meaning that insulin - an important chemical the body makes to~     keep blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by~     improving insulin sensitivity. Stress is related to insulin sensitivity. Individuals who~     feel stressed have worse insulin sensitivity than individuals who do not feel stressed. In~     adults, decreasing stress leads to improvements in insulin sensitivity, but this hasn't been~     tested in teenagers. The purpose of this study is to find out if taking part in a brief~     group program to decrease stress will improve insulin sensitivity and lower diabetes risk in~     teenage girls.~   "
64112|NCT02218125|"~     The purpose of this study is to assess the safety and tolerability of Modified Vaccinia~     Ankara (MVA) Mosaic vaccine in healthy adult participants.~   "
64113|NCT02218112|"~     The sympathetic nervous (SNS) and the renin angiotensin aldosterone system (RAS) have a~     direct impact on renal hemodynamic, hormonal secretion and vasoactive peptide. Many~     mechanisms including the SNS, RAS and renal sodium handling could explain the pathogenesis~     of hypertension in obese patients. Lifestyle changes and bariatric surgery induce weight~     loss, which is associated with blood pressure lowering in obese patients. A diminution in~     the renal sympathetic stimulation and RAS activation could explain this effect.~      The AIM of this study is to show that weight loss induced by bypass surgery in obese~     patients affects renal salt excretion under  low body negative pressure (LBNP) conditions~     .~      Secondary objectives are to investigate the impact of weight loss on renal hemodynamic~     (glomerular filtration rate (GFR), renal plasma flow) and neurohormonal responses under ~     low body negative pressure conditions . We will also analyse renal blood oxygenation with~     Blood Oxygenation dependant IRM (BOLD-IRM) technique before and after weight loss.~      The population of this study will consist in two groups including 36 patients. The first one~     will include 24 obese patients that are going to undergo a bariatric surgery. The second one~     will include 12 obese patients without any weight loss associated surgery.~      Both group will undergo 3 investigation days. Each patient will have to undergo a screening~     visit that will provide dietary advice to ensure a standardized salt intake (120-180~     mmol/day) for the duration of the study. The first investigation will define baseline, the~     second and third day of investigation will take place after 3 month and 12 month after~     bariatric surgery for surgical patients or after baseline for patients without surgery. One~     to two weeks before phase 1 and 3 patients will perform a BOLD-MRI. The surgery group will~     undergo bariatric surgery between the first investigation phase (baseline) and the second.~     An ambulatory blood pressure and 24-hour urine collection will precede each investigation~     day. An investigation day consists in renal hemodynamics, neurohormonal and natriuretic~     response measurements before, during and after 60 min of LBNP at -30mbar . The duration of~     the study per subject is going to take 12 months.~   "
64114|NCT02218099|"~     This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK~     and PD of a single dose of ASP8232. In addition, the safety and tolerability will be~     assessed.~      Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232~     compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney~     Disease (CKD).~   "
64115|NCT02218086|"~     Slacklines have been established in the last few years as a training equipment in sports~     such as climbing, skiing and others to increase postural control. Furthermore, slacklines~     are used in physiotherapy in terms of stabilizing training such as wobbling boards.~      However, if slackline training is effective in rehabilitation has not been investigated yet.~     Therefore, to goal of this study will be to investigate the effectivity of slackline~     training in physiotherapy compared to a wobbling board with a single tilting axis.~      Outcomes will be electromyographic-data and the kinetics of the whole body.~   "
64116|NCT02218073|"~     The purpose of this study is to evaluate the absolute bioavailability (the extent to which a~     drug or other substance becomes available to the body) of JNJ-42756493 following a single 10~     milligram (mg) dose as an oral solution administered in combination with a single~     intravenous administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to~     evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution~     (reference) and a tablet (test) formulation in a crossover (method used to switch subjects~     from one study group to another in a clinical trial) design in healthy participants.~   "
64117|NCT02218060|"~     Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when~     a patient is suspected of having coronary artery disease. The test, however, requires~     relatively high levels of radiation, which have been linked to DNA damage and cancer, and~     the use of contrast material, which can affect kidney function. The SOMATOM Force, a new~     third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and~     holds the potential to obtain quality images while also reducing radiation dose and contrast~     material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting~     coronary artery disease and also see if radiation dose and contrast material are reduced~     compared to the previous 2nd generation scanners. It is suspected that the Force will~     provide clinical quality images while decreasing radiation dose and contrast material~     required.~   "
64161|NCT02217488|"~     This clinical trial investigated the safety, tolerability and pharmacokinetic profile of~     DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1~     study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via~     single dose subcutaneous injection.~   "
64118|NCT02218047|"~     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic~     increase of red blood cells and frequently also of white blood cells. The thickening of~     the blood in relation with a modified function of the cells has several consequences like~     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the~     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis~     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,~     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an~     additional risk of bleedings. As the disease progresses the size of spleen and liver~     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a~     progression at a later time point to a leukemia (increased formation of white blood cells)~     can occur.~      The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon~     alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm~     is receiving best available therapy as selected by the investigator. Response to the~     treatment is measured by several blood parameters as well as size of the spleen.~      Interferon-alpha has been shown to be effective in controlling the blood parameters by~     immunologically influencing the blood building cells. This can lead to a suppression of the~     disease-causing stem cells and help healthy stem cells to proliferate. Through this~     mechanism it is possible that Interferon-alpha can avoid long-term damaging effects of the~     disease.~   "
64119|NCT02218034|"~     This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with~     acne vulgaris.~   "
64120|NCT02218021|"~     The purpose of this study is to evaluate the abuse potential and safety of samidorphan in~     healthy, non-dependent, adult, recreational opioid users.~   "
64121|NCT02218008|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
64122|NCT02217995|"~     Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have~     reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive~     Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges~     with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI~     treatment, partial symptom reduction is substantial. Investigations into the effectiveness~     of alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as~     paying attention in a particular way (on purpose, in the present moment and~     nonjudgmentally), promotes awareness and attention to internal experience and has been shown~     to reduce symptoms of anxiety and depression. A number of controlled studies have found~     Mindfulness-Based Cognitive Therapy (MBCT) to be effective for depression, social anxiety~     disorder, and generalized anxiety disorder, but few have tested its effect on obsessive~     compulsive disorder (OCD). Moreover, those studies examining MBCT in OCD focused on clinical~     case studies and non-clinical samples. This study proposes to examine the effect of MBCT in~     clinical practice, in a randomized sample of patients with OCD whom are on a clinic wait~     list. As patients are allocated to the wait list, they will be randomly assigned to receive~     either 10 weeks of group MBCT or wait list as per usual. It is hypothesized that subjects~     randomly assigned to the MBCT treatment group, compared to those in the wait list control~     group, will see greater reductions in self-reported measures of OCD symptom severity and~     improvement in other measures of mindfulness, mood and level of functioning. The results of~     this pilot study, if successful, will provide evidence towards another route by which~     patients can improve their OCD while waiting for clinic services or consultation. Results~     will also lend more evidence as to whether MBCT is effective as a stand-alone treatment for~     clinical OCD, which will inform further investigations into the potential addition of~     mindfulness techniques to standard care.~   "
64123|NCT02217982|"~     Single site, open label, randomized design in patients with relapsing forms of Multiple~     Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS~     scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF),~     including the titration period.~      After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any~     category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be~     reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater~     than or equal to 3.5 in at least one of the key categories will be randomized to a standard~     therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period~     will be terminated from the study at this visit. Patients with an average reported MAGIS of~     greater than 6.5 at Baseline will be placed in the treatment arm.~      Patients who are randomized to the treatment arm will be instructed to take 125 mg~     simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each~     DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will~     also be instructed to take 2 mg loperamide three times daily.~      Patients randomized to the standard therapy arm will be instructed to follow the normal~     dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms~     (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to~     the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over~     the past 24 hours using the MAGIS scale once daily.~      Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily.~     Patients will return to the clinic at Week 3 and Week 6/End of Treatment for diary and~     compliance review. After Week 6, patients will be instructed to return to a standard~     therapy. MAGIS will be recorded for one more week and collected at Week 7/End of Study.~   "
64124|NCT02217969|"~     Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having~     their anesthesia team alerted or kept blinded to extended periods of less than normal blood~     pressure with the goal of studying if providing these alerts leads to improved outcome after~     surgery (lower risk of death or complication in the days and weeks following surgery).~   "
64125|NCT02217956|"~     HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background.~     Few studies have been published on the use of HCIP in peritoneal carcinosis from ovarian~     background but most of them were non-randomized phase II studies on a small population using~     different type of drugs and dosage. before this heterogeneity it seems necessary to~     standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian~     background~   "
64126|NCT02217943|"~     The primary goal of this study is to assess impact of metabolic surgery on glycemic control~     in diabetic patients.~   "
64127|NCT02217930|"~     The study designed to determine the effect induced by WCK 2349 on the QT interval.~      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)~     to assess the safety of high doses of single-dose administration of WCK 2349 on the QT~     interval.~   "
64128|NCT02217917|"~     This is a 2 part study designed to provide an initial assessment on the safety,~     tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple~     ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of~     the study will be conducted using a cross-over design while Part 2 of the study will be~     conducted using a parallel design.~   "
64129|NCT02217904|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral~     therapy (ART) activity of MK-8591 monotherapy in ART-naive, human immunodeficiency virus-1~     (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose~     of MK-8591, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction~     from baseline between MK-8591 and placebo is at least 0.5 log (base10) copies/mL.~   "
64130|NCT02217891|"~     The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address~     this research gap by examining MSK patients' attitudes, preferences, and information needs~     regarding incidental findings arising from tumor genomic profiling.~   "
64131|NCT02217878|"~     The purpose of the IMPRESSION study is to determine whether intravenous administration of~     morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction~     (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients~     alters the plasma concentrations of ticagrelor and its active metabolite and whether it is~     associated with any negative impact on the antiplatelet effect of ticagrelor.~   "
64132|NCT02217865|"~     The long-term goal of this research is to develop new tools to guide patients, caregivers,~     and clinicians in making individualized decisions regarding colorectal cancer (CRC)~     surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract,~     principal investigator will analyze surveillance data to determine the effectiveness of CRC~     surveillance and recurrence risk taking into account different patient and tumor~     characteristics; identify key issues about CRC surveillance important to patients,~     caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a~     patient-centered, risk stratified surveillance strategy by creating an interactive decision~     aid for use by patients and clinicians.~      The specific aims of the study are:~      Aim 1 - Determine the effectiveness of surveillance of colorectal cancer patients following~     curative resection and the factors associated with recurrence treatment eligibility.~      Aim 2 - Identify key priorities for surveillance that are important to patients and~     clinicians through stakeholder engagement.~      Aim 3 - Develop a patient-centered risk-stratified surveillance strategy utilizing a novel,~     interactive, decision aid to facilitate shared decision making.~      This protocol addresses a formative step in the creation of the interactive decision aid~     where patients' information needs and preferences are assessed regarding decisions about~     surveillance.~      The specific aims of this protocol are:~      Phase 1 - To interview patients and their caregivers to determine their concerns,~     preferences and key priorities regarding surveillance after curative resection of colorectal~     cancer, and~      Phase 2 - To refine the key priorities identified in phase 1 through focus groups and~     surveys with patients and caregivers.~   "
64133|NCT02217852|"~     Several surveys had revealed that Tibetan adults had high prevalence of hypertension.~     However, there was no research studying the antihypertensive effect of the known drugs in~     Tibetan. The main arms of our study were to determine if the efficacy of lowing blood~     pressure and protecting target organ damage differs between nitrendipine and~     Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of~     lowing blood pressure and protecting target organ damage differs between captopril plus~     Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan~     hypertension.~   "
64134|NCT02217839|"~     This multi-ascending dose study is designed to investigate the safety, tolerability,~     pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48~     healthy volunteers.~   "
64135|NCT02217826|"~     In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated~     with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173)~     and placebo control. The main purpose of the study was to investigate the effects of each~     treatment on the control of plasma glucose as well as the secretion of insulin and glucagon~     following a standard meal.~   "
64136|NCT02217813|"~     Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis~     blood concentrations will be measured periodically for one week. After about 20 days,~     subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis~     concentrations from the two different formulations will be compared to determine if they are~     approximately the same.~   "
64137|NCT02217800|"~     This study is designed to assess the effect of the different continuous s.c. infusion~     treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in~     comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and~     the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.~   "
64138|NCT02217787|"~     This study has been designed to investigate the effect of high fat food on the~     pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.~   "
64139|NCT02217774|"~     The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS),~     consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by~     evaluating the difference between planned and actual implant positions on pre- and~     post-operative CBCTs.~   "
64140|NCT02217761|"~     The purpose of this study is to investigate the factors influencing pharmacokinetic and~     pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.~   "
64141|NCT02217748|"~     The objective of our study was to determine the extent to which the order of specific items~     in a multiple name generator survey affects how social networks are measured.~   "
64142|NCT02217735|"~     This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to~     neutral writing in individuals with Parkinson's Disease and their support persons.~     Participants will be randomly assigned to complete three, 20 minute sessions of expressive~     or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate~     post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of~     these therapies on thinking abilities, physical health, and patient and support person~     ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing~     is hypothesized to result in greater improvements and/or stability of function on~     neuropsychological tests of attention, working memory, learning, and memory skills compared~     to the neutral writing condition.~      Results from this study will determine whether brief writing exercises are easily used by~     and beneficial for individuals with Parkinson's Disease and their support persons. If~     positive benefit is observed, information from this study will be used to further optimize~     these therapies for larger trials designed to evaluate the value of the therapies for~     individuals with Parkinson's Disease and their support persons.~   "
64143|NCT02217722|"~     The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of~     Remission. The investigators have postulated that we developed could be beneficial for~     patients with Ulcerative Colitis. To date, no study has explored this possibility.~   "
64144|NCT02217709|"~     This phase II trial studies phenelzine sulfate in treating patients with prostate cancer~     that has not spread to other parts of the body and has come back. Phenelzine sulfate is a~     type of antidepressant that works by decreasing the amount of a protein called monoamine~     oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.~   "
64146|NCT02217683|"~     The objective of this study is to assess if prolonged storage time of a packed red blood~     cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible~     population such as cardiac surgery patients. The investigators will also evaluate the~     potential reversal effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by~     stored blood transfusions.~   "
64147|NCT02217670|"~     The main purpose of this study is to assess comparative bioavailability of a test~     formulation of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt.~     Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) relative to~     Glucophage 1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects~     under fed conditions. The second aim is to asses the safety of subjects and to determine~     other pharmacokinetic data.~   "
64148|NCT02217657|"~     This prospective, randomized study will investigate, if information of the catheter force~     during ablation of a left anterior line does reduce total RF application time by prevention~     of ineffective lesions.~   "
64149|NCT02217644|"~     -  Investigation of safety and tolerability of BI 653048 H3PO4 following the~          administration of single rising doses of an aqueous solution in healthy male subjects~        -  Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the~          investigation of dose proportionality~        -  Investigation of relative bioavailability of capsules versus aqueous solution~   "
64150|NCT02217631|"~     The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and~     pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.~   "
64151|NCT02217618|"~     The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is~     to determine how much LY2409021 enters the bloodstream and how long the body takes to get~     rid of the drug after the dose. This study will last approximately 28 days, not including~     screening. Screening can occur within 30 days prior to the start of the study.~   "
64152|NCT02217605|"~     The purpose of this study is to determine the effects of an oral fructose challenge on liver~     adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a~     potential measure measure of liver health.~   "
64153|NCT02217592|"~     This is an observational study to identify the aetiology and factors associated with outcome~     of community-acquired sepsis and severe sepsis in Northeast Thailand.~      Potential study participants will be adult patients who are presented at the hospital with~     community-acquired sepsis. Clinical specimens (including blood, urine, sputum and throat~     swabs) will be collected from each participant on admission for culture, PCR and serological~     tests, and other laboratory tests, including inflammatory markers and genotyping.~     Participants' treatment will be closely monitored during the duration of their hospital~     stay. Blood will be again collected at 72 hours after admission. Participants will be~     contacted at 28 days after admission to determine clinical outcome by phone interview with~     standardized script.~      There will be a total of 5,020 patients enrolled in this study over 3 years.~   "
64154|NCT02217579|"~     The metabolic syndrome is rising worldwide as a consequence of the continued obesity~     epidemic. The current obesogenic environment makes the regulation of energy intake difficult~     and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb~     hunger and reduce energy intake are critically needed. We hypothesize that inclusion of~     protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity~     adults.~   "
64155|NCT02217566|"~     The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen~     (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer~     cells from one part of the body to another) castration (any action, surgical, chemical, or~     otherwise, by which a male loses the functions of the testes) resistant prostate cancer~     (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC),~     chemo-naive (treatment of cancer is not done using drugs), who received a prior~     diethylstilbestrol therapy (DES).~   "
64156|NCT02217553|"~     Platelets play pivotal role in atherosclerosis and acute cardiovascular events. Platelet~     hyperreactivity and increase platelet-monocyte aggregate (PMA) formation are found in HIV~     infected patients, which may contribute to the excess cardiovascular risk. Low level of~     vitamin D has been associated with the presence of cardiovascular diseases. The aim of our~     study is to determine the effect of vitamin D supplementation on platelet activation,~     platelet reactivity and platelet-leukocyte complex formation in asymptomatic HIV-infected~     patients treated with ART~   "
64157|NCT02217540|"~     Objective: To pilot the methods proposed for conducting a full randomised clinical trial to~     evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality~     in older adults with shoulder dysfunction.~      Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes,~     Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions:~     Participants will be randomly allocated into control group (n=22) treated with a~     physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and~     experimental group (n=22) treated with the same physical therapy standard protocol and~     Mulligan concept mobilisation with movement. Both interventions will take place three times~     a week for 2 consecutive weeks.~      Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability~     Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range~     of motion and pain intensity. Data will be collected at baseline, after each group~     intervention, and 1 and 3 months after finishing interventions.~   "
64158|NCT02217527|"~     The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid~     cessation during a one-week practice quit period for each condition in smokers with a high~     interest in quitting (i.e. crossover design). Medication effects on reducing craving,~     withdrawal, and cognitive impairment will help assess the mechanism to support quit smoking~     attempts.~   "
64159|NCT02217514|"~     Evaluation of the long-term (48 h) and short-term (1 h) effects of BI 44370 BS on the~     pharmacokinetics of midazolam as marker of a possible inhibition of CYP 3A4; safety and~     tolerability.~   "
64160|NCT02217501|"~     The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of~     aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will~     lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction~     (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at~     end of study treatment.~   "
64163|NCT02217462|"~     The primary purpose of this observational cohort study is to examine the role of food~     reward in maternal diet and weight change during pregnancy and postpartum. The study will~     further examine the importance of food reward in the context of behavioral control and other~     related aspects of eating behavior, as well as weight-related biomedical, psychosocial and~     behavioral factors including genetics, physical activity, stress, sleep and depression. Four~     hundred and fifty women of varying baseline weight status will be enrolled early in~     pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments~     will occur at baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation,~     16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months.~     Measures will include assessments of food reward and related constructs, dietary intake,~     other health behaviors, and anthropometrics. Clinical data and biological specimens will be~     obtained. Infant anthropometrics and feeding practices will also be assessed. Primary~     exposures include aspects of food reward and behavioral control, which will be assessed in~     multiple ways to maximize information and utility. Primary outcomes include gestational~     weight gain, postpartum weight retention and dietary quality.~   "
64164|NCT02217449|"~     To assess the accuracy of predicting histology with virtual chromoendoscopy for distal~     colorectal polyps according to the ASGE PIVI statement.~   "
64165|NCT02217436|"~     Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency~     department with facial lacerations requiring suture repair will be eligible to participate~     in the study. Participating children will be randomized to standard care versus standard~     care plus iPad use during the procedure. Children's anxiety levels assessed using a~     validated scale will be measured from video recordings made of the procedure. Parent and~     provider satisfaction surveys will be completed following the procedure. The primary study~     aim is to determine how iPad use affects children's anxiety levels during facial laceration~     repair. The secondary study aim is to determine how iPad use affects parent and provider~     satisfaction regarding a child's facial laceration repair. Hypothesis is that iPad use~     decreases children's anxiety levels during facial laceration repair and increases parent and~     provider satisfaction regarding a child's facial laceration repair.~   "
64166|NCT02217423|"~     The purpose of this study is to determine whether the hospitalized patients with increased~     waist circumference exhibit cardiorespiratory alterations after chest physical therapy.~   "
64167|NCT02217410|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK)~     and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar~     rate of acute rejection prophylaxis and renal function in a de novo renal transplant~     population receiving an allograft from standard criteria donors.~   "
64168|NCT02217397|"~     Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during~     sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was~     the standard therapy, especially those with daytime sleepiness and cardiovascular~     comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high~     pressure was often reported. Instead, oral appliance (OA) was the alternative for those who~     could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in~     compared with CPAP, but OA is more tolerable and acceptable in OSA patients.~      Only one observation study addressed the effects of the combinations of OA and CPAP in OSA~     patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA~     patients and could decrease CPAP pressure. However, the study enrolled the patients with~     CPAP intolerance according to the subjective chief complaint, not the objective CPAP~     pressure data. In the present study, we studied the effects of combinations of CPAP and OA~     for patients with severe OSA who could not tolerate CPAP with high-pressure setting.~   "
64169|NCT02217384|"~     Background. Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric~     disease, and less than half of the patients recover, completely refractory to any treatment.~     The etiology remains unknown and evidence for treatment is lacking. The intestinal~     microbiota and its microbiome provide humans with additional gene products which may be~     regarded as an organ, which contributes to multiple host metabolic pathways. Recent advances~     in microbial DNA sequencing technologies have resulted in metagenomic DNA analysis of whole~     ecosystems such as the human gut. Altered intestinal microbiota has been related to obesity~     and insulin resistance. Hypothetically, the intestinal microbiota could play a role in the~     generation and/or maintenance of the emaciation in AN.~      Aim. The aim of the present study is to investigate whether gut microbiota is altered in~     patients with AN.~      Subjects and methods. A cross sectional study of the gut microbiome profiles in 75 clinical,~     psychometric and biochemical well characterized treatment seeking females with AN. The~     microbiome profiles are compared with 75 age- matched healthy Danish control subjects.~      Perspectives. Clarifying whether the intestinal flora is implicated in the susceptibility to~     or maintenance of AN may provide the basis for development of new highly required~     treatments.~   "
64170|NCT02217371|"~     In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of~     Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without~     Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep~     disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or~     Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep~     disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,~     we wish to determine potential changes in the regulation of sleep / wake cycle through a~     protocol of extended wake.~      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD~     and healthy subjects during a protocol of extended wake.~      It's an observational study of interventional type realized in patient with ADHD syndrome~     deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the~     implication of the homeostatic and circadian systems in the preservation of awakening.~   "
64195|NCT02217046|"~     Cardiovascular implantable electronic device (CIED) infections have been increasing out of~     proportion to the number of devices implanted the investigators investigated recent trends~     and possible causes of the increasing numbers of Cardiovascular implantable electronic~     device infections.~   "
64196|NCT02217033|"~     The purpose of this study is to evaluate the effects of consuming R on quality of life in~     the areas of insomnia, fatigue, and depression in female breast cancer patients receiving~     multi-cycle adjuvant chemotherapy.~   "
64171|NCT02217358|"~     The aim of the project is to compare NBI endoscopy and standard endoscopic method using~     white light and evaluate accuracy both methods in early detection and diagnosis~     hypopharyngeal and laryngeal precancerous and cancerous lesions. A higher contrast between~     the mucosal epithelium and blood vessels is achieved in NBI endoscopy using filtered light~     comparing to white light observations. This allows detection of small mucosal changes, few~     millimetres in diameter, which are not observable using white light. The second aim in~     patients with squamous cell carcinoma of the upper aerodigestive tract is to compare~     extension of mucosal lesions by evaluation of NBI endoscopy and white light endoscopy, which~     is crucial for perform targeted biopsy and for determination of resection margins in cancer~     surgery. The investigators expect that dysplastic changes of mucosa or early laryngeal~     cancerous lesions are detected in white light endoscopy rarely. In case our hypothesis is~     confirmed, frequency of precancerous and early cancerous lesions of hypopharynx and larynx~     is more common in patients with non-specific symptoms of laryngeal and pharyngeal diseases.~   "
64172|NCT02217345|"~     Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of~     alcohol use, is an increasingly recognized complication of obesity, with prevalence~     estimates of about 30% of individuals in the United States. A subset of these will develop~     progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress~     to cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver~     transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will~     decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy~     (1H-MRS).~   "
64173|NCT02217332|"~     Phase 2, open-label, multi-center study to evaluate the clinical effects of oral~     administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal~     polyps and eosinophilia.~   "
64174|NCT02217319|"~     It has been shown that the use of volatile anaesthetics, that are usually used to perform a~     general anesthesia, have cardioprotective properties. This has been shown in animal studies~     and in patients that underwent cardiac surgery. The aim of our study is to examine if~     Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung~     surgery.~   "
64175|NCT02217306|"~     Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can~     be modified by different pathologies or by age. The purpose of this study is to identify the~     changes that could be in relationship with the course of diabetic retinopathy comparing with~     diabetic patient without retinopathy and in patients with diabetic macular edema so if it is~     a difference, research for therapeutic strategies to improve it in this patients.~   "
64176|NCT02217293|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although~     many conservative forms of management including the use of wrist splint, steroid injections~     and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or~     short-lived.~      Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade,~     was found to be able to alleviate pain for certain kinds of chronic pain conditions without~     damaging nerve. However, the application of PRF in CTS is scarce.~      The purpose of this study was to assess the analgesic effect and prognosis of~     ultrasound-guided PRF in the median nerve in patients with CTS.~   "
64177|NCT02217280|"~     This study will analyze injectate dispersal patterns after standard-of-care cervical~     epidural steroid injections using gadolinium as a marker and magnetic resonance imaging~     (MRI) to characterize the pattern. Although these procedures are performed with high~     frequency under the assumption that injectate remains localized to injection site, no~     peer-reviewed studies have validated this assumption. Comprehensive characterization of~     injectate dispersal patterns will provide important data regarding safety, as well as~     diagnostic and therapeutic potential of cervical epidural steroid injections.~   "
64178|NCT02217267|"~     The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion~     when compared with placebo in peripheral neuropathic pain patients in acute stage (less than~     6 months) at 3 months after first time of infusion~   "
64179|NCT02217254|"~     It is an unproven assumption that at least 2 cryoablations is necessary in each pulmonary~     vein for successful ablation of atrial fibrillation. The investigators hypothesize that a~     single cryoablation in each pulmonary vein that achieves isolation may leads to equivalent~     efficacy with decreased risk. The One Freeze Study evaluates this hypothesis.~      This study compares one 3-minute cryoablation per pulmonary vein versus two 3-minute~     cryoablations per pulmonary vein during atrial fibrillation ablation procedures.~   "
64180|NCT02217241|"~     The purpose of this study is to assess the effectiveness of an educational intervention on~     handoffs implemented during the third year of medical school. It also assesses whether these~     skills are maintained over time into their fourth year of training and whether there is~     transfer from the simulated setting into the clinical environment.~   "
64181|NCT02217228|"~     Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia~     microparticles with or without laser in the treatment of moderate to moderately-severe~     inflammatory acne vulgaris~   "
64182|NCT02217215|"~     The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy~     can improve the ability to detect the presence of premalignant lesions on the cervix.~   "
64183|NCT02217202|"~     The aim of the study is to determine whether the AQUACEL™ Ag SURGICAL cover dressing is~     successful in reducing the incidence of wound infection in high risk patients following~     total knee replacement. We will also look at the status of the wound, occurrence of~     blistering, biochemistry results, dressing wear time and the number of dressing changes to~     quantify the dressing performance.~   "
64184|NCT02217189|"~     Although several studies have considered the relationship between infertility and semen~     super oxide radical scavengers levels, no study on the effects of asthenospermia treatments~     such as oral zinc supplementation on superoxide radical scavengers activity which are~     important in fertility of the individual has been reported.~   "
64206|NCT02216903|"~     This is the evaluation which is associated with apnea symptom, one of the recurrence~     factors, after AF ablation to patients who diagnosed AF.~      This is the evaluation which is associated with excessive respiration exercise during AF~     ablation to patients who diagnosed AF.~      This is the evaluation which is associated with excessive respiration exercise to make a gap~     during AF ablation to patients who diagnosed AF.~   "
64185|NCT02217176|"~     Internal jugular venous catheterization is a challenging procedure in pediatric patients due~     to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery~     (CCA) may jeopardize the success and increase the complication rate.However, the use of~     ultrasound as an assistance tool might be helpful to identify the relationship between the~     IJV and the CCA. Endotracheal intubation and insertion of laryngeal mask are the common~     options for the airway management during general anesthesia for central venous~     catheterization. In this observational study, the investigators aimed to investigate the~     impact of the laryngeal mask insertion or endotracheal intubation and the role of head~     rotation on the overlap of the IJV and CCA evaluated with ultrasound in pediatric patients~     undergoing any kind of surgical procedure.~   "
64186|NCT02217163|"~     Patients with high risk multiple myeloma have shorter remission periods and reduced overall~     survival. Prognostic significance of minimal residual disease negative remission is being~     highlighted in many of the newer studies.~      The current phase 2 study investigates the combination of carfilzomib together with~     cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger~     transplantation eligible patients.~   "
64187|NCT02217150|"~     Prospective clinical series to gather post tumor ablation clinical outcomes from subjects~     with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment~     with the STAR™ Tumor Ablation System.~   "
64188|NCT02217137|"~     Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic~     autoimmune diseases that have been reported to affect the ocular surface of patients [1,2].~     However, the nature of the disturbances of the ocular surface immunity and their~     relationship to systemic disease severity are poorly understood.~      This study aims to profile the ocular surface inflammation of RA and SLE patients by a.,~     analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical~     imaging for conjunctival redness and tear stability.~      20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the~     Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another~     20 age matched controls for RA will be recruited.~      All participants will undergo~        1. Tear collection with Schirmer strips~        2. EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling~        3. Clinical ocular surface assessment with Oculus Keratograph 5M~        4. Collection of blood via venipuncture (optional)~        5. Retrieval of Clinical Information of participants~      The association of cytokines in the tears with various cellular and immune markers, as well~     as clinical signs of inflammation and tear stability will be investigated. This will be~     useful for further longitudinal studies of treatment in autoimmmune disease patients.~   "
64189|NCT02217124|"~     The primary objective of the proposed research is to determine the influence of 8 weeks of~     twice daily consumption of 120 kcal servings of dried apples or a commonly consumed lowfat~     120kcal muffin on components of obesity (waist circumference [waist measurement], serum~     glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood~     pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight~     and obese individuals. A total of 48 children aged 12-15 years will be randomly assigned to~     groups and provided with twice daily 120 kcal servings of either dried apples or muffins for~     8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood~     samples will be collected and analyzed. During each visit to the lab, subjects will be~     weighed in minimal clothing, tested for body composition using dual energy X-ray~     absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography~     (Bod Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will~     be performed prior to initiation of the study; one recall will be performed throughout the~     feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,~     vitamins and minerals will be assessed to determine diet quality. All food records will be~     analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the~     study include determining the effects of consistent snacking and particular snack foods on~     metabolism and weight management. There are no major risks to subjects in this study. There~     are minimal risks when performing venipuncture (blood draws) including bruising, perforation~     of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of~     needles, and infection. This study will hopefully allow more understanding and insight into~     the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized~     that the twice a day apple snack group will have decreased waist circumference, body~     adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at~     the end of 8 weeks.~   "
64190|NCT02217111|"~     The purpose of this prospective study is to obtain preliminary data on changes in pre-post~     voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a~     series of cognitive operations. The primary outcome is voice-related quality of life~     (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived~     from sustained vowel and running speech samples.~   "
64191|NCT02217098|"~     The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate~     when used for the treatment of occlusal and proximal caries in primary molars with ART under~     field conditions.~      This research will be done under field conditions in Barueri, a city in the state of São~     Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months~     the restorations and teeth will be evaluated by two independent evaluators. Only children~     whose parent or representative who have signed an informed consent are included in this~     research.The ART treatments will be done by two dental students. The operators will receive~     the same ART-training. The children will be randomly assigned to one of the operators. The~     restorative material to be used in each child will be assigned by another random list. It~     will be performed descriptive analyses to describe the sample. Bivariate analyses will be~     performed to test the hypothesis. The data will be analyzed with a chi-square test to~     compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as:~     operator effect, the influence of the cavity size on the survival rate, the position of the~     tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the~     preoperative conditions. The effect of these variables on the survival rate will be~     evaluated using a regression analysis.~   "
64192|NCT02217085|"~     The purpose of this study is to determine the best way to ensure that polyps are completely~     removed by evaluating the borders of the removed polyp. If a polyp is found that meets the~     size requirements for the study, the investigators will take extra biopsies of the margin to~     determine if there is any abnormal tissue or cancer at these borders.~   "
64193|NCT02217072|"~     A Randomized controlled study of two different educational support interventions developed~     for children in foster care (age 6-13).~   "
64194|NCT02217059|"~     The purpose of this study is to evaluate the Congruence of Emergency Department (ED)~     Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.~   "
64197|NCT02217020|"~     The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation.~     However, preoperative radiation cause kinds of adverse events, some were irreversible. And~     the survival benefit was not obvious. Whether chemotherapy alone is effective enough in~     treating rectal cancer is not yet known. Here, the investigators chose all the three active~     cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen~     (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as~     neoadjuvant regimen in treating patients with locally advanced rectal cancer.~   "
64198|NCT02217007|"~     This is an open-label study of SNC-102 (acamprosate calcium sustained release tablet) in~     adult subjects with Tourette Syndrome. Subjects will be treated with oral doses of SNC-102~     800 mg on a BID basis - before breakfast and at bedtime - for 4 weeks and the same subjects~     will be treated with SNC-102 1600mg in the morning and 800mg in the evening for an~     additional 4 weeks. Subjects will be assessed for changes in tic severity, safety, and~     pharmacokinetics. The study hypothesis is that treatment with SNC-102 will improve the tic~     severity in adult subjects with Tourette Syndrome.~   "
64199|NCT02216994|"~     1. The investigators previously reported a simple diagnostic scoring system to~          differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders~          (HAD) in the patients with suspected intestinal dysganglionosis. In the retrospective~          study, the investigators concluded that the patients with a predicting score of more~          than 5 are more likely to be diagnosed with HD, whereas a score less than 5 is mostly~          indicative of HAD.~        2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a~          prospective manner before it is used as a standard procedure, this prospective study is~          designed and performed.~   "
64200|NCT02216981|"~     The purpose of this study is to examine how feasible and acceptable it is to deliver a~     talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for~     people who have had treatment for OCD in the past but it didn't work out for them.~      The two different treatment formats are CBT delivered on a weekly basis (which is~     approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session,~     followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format~     (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by~     1-3 monthly follow up sessions as needed).~   "
64201|NCT02216968|"~     The purpose of this study is to test the feasibility of an innovative approach to increase~     the amount of vegetable's (V) intake consumed by preschool children who are predominately~     African-American (AA) and Hispanic-American (HA).~   "
64202|NCT02216955|"~     China has the largest gastric cancer patients population all over the world. Recent reports~     concluded nutrition status and lifestyle factors were associated with gastric cancer risk,~     however, the influence of nutrition and lifestyle factors on cancer outcome in gastric~     cancer survivors is largely unknown.The investigators will explore the impact of nutrition~     status, life style, dietary pattern, obesity, physical activity, depression, diabetes,~     aspirin use and vitamin supplement on gastric cancer outcome. The investigators will recruit~     approximately 50,000 patients as a prospective study cohort. During follow up, the~     investigators will explore the association of these factors with disease-specific survival,~     disease-free survival and overall survival of patients. The investigators believe that this~     project will facilitate the establishment of domestic nutrition and lifestyle data of~     gastric cancer of China, and the improvement of the quality of clinical management of~     patients with gastric cancer.~   "
64203|NCT02216942|"~     The maintenance of primary teeth until their exfoliation has been one of the main purposes~     of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of~     the permanent dentition. Often, injuries or extensive dental caries reach the pulp of~     deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this~     study was to conduct a randomized clinical trial with longitudinal follow-up of two years,~     double blind, to compare the degree of success of endodontic treatment in primary among the~     most used folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to~     control, Vitapex.~   "
64204|NCT02216929|"~     The demographic data, mortality rates and clinical diagnoses of the patients who were~     evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent~     consultation call from the emergency department in 2010-2011.~      Primary outcome: an examination of demographic data, predicted mortality rates and the~     clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio~     Inclusion criteria: patients throughout the hole hospital whom was intubated by the~     anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who~     refused treatment~   "
64205|NCT02216916|"~     Head and neck cancer is the sixth most common cancer and more than 650,000 new cases are~     diagnosed each year worldwide. About 60% of the HNSCC patients present with unresectable~     locally advanced disease at diagnosis and treated with multimodality approach. Despite such~     approach, majority (70%) of patients develop local or/and regional recurrences. Additional~     10% of patients present with distant metastasis at diagnosis. Most patients with recurrent~     or metastatic disease are treated with single agent chemotherapy, combination chemotherapy~     or targeted therapies.~      Despite its public health magnitude, HNSCC in Asian countries has received a limited~     attention for the drug development and cancer-related research. In fact, HNSCC ranked 7th~     among men and 10th among women by incidence in China, the largest producer and consumer of~     tobacco and alcohol. Recently, Chen et al. documented a 1:1:2 subset distribution for~     cancers of oral cavity, pharynx, and larynx in China, similar to the distribution reported~     in Korea but quite different from the general distribution of 5:2:3 in whites. Ethnic~     disparities in HNSCC also include its prognosis and this is partly explained by HPV-active~     disease ratio and genetic factors. Therefore, there is a strong need for an additional~     research in patients with HNSCC in Asia.~      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with HNSCC. The association between EGFR-activated signaling~     pathways and tumor cell survival are well documented in many studies. EGFR targeting~     strategies showed clinical anti-tumor efficacy in patients with HNSCC, especially with~     monoclonal antibody, cetuximab. In the Extreme study, it was shown that the addition of~     cetuximab to platinum-5-FU significantly prolonged the median overall survival from 7.4~     months to 10.1 months compared to platinum-5FU alone in the first-line setting.~      HM781-36B is a irreversible pan-HER inhibitor. In preclinical studies, HM781-36B has much~     lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations and~     produces tumor growth inhibition in gefitinib-resistant xenografts. A phase I trial of~     HM781-36B in patients with advanced solid tumors showed clinically significant anti-tumor~     activity and a phase II trials of HM781-36B in patients with non-small cell lung cancer and~     advanced gastric cancer are currently ongoing.~      We suggest a phase II trial of HM781-36B in patients with recurrent or metastatic HNSCC who~     are resistant or ineligible/intolerant to platinum-based chemotherapy. The aim of current~     trial is to evaluate the antitumor efficacy and safety profile of HM781-36B and to identify~     biomarker to predict the tumor response to HM781-36B.~   "
64248|NCT02216357|"~     The primary objective of the study is to determine the safety of oral ifetroban compared to~     placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of~     Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the~     aspirin challenge.~   "
64207|NCT02216890|"~     This study will examine the safety profile of SGN-CD70A. The study will test increasing~     doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks)~     to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be~     given to patients without causing unacceptable side effects. The pharmacokinetics and~     antitumor activity of SGN-CD70A will also be evaluated.~   "
64208|NCT02216877|"~     Randomized placebo-controlled interventional trial to investigate the effect of oral~     magnesium supplementation on intracellular magnesium in subjects with chronic kidney~     disease. We hypothesize that oral magnesium supplementation will increase intracellular~     magnesium in subjects with chronic kidney disease as well as increase serum magnesium.~   "
64209|NCT02216864|"~     The purpose of this study is to find out whether the use of multiple subcisions over several~     visits will improve the appearance of rolling acne scars compared to no treatment.~      This study was a pilot study designed to determine feasibility of this procedure.~   "
64210|NCT02216851|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane~     to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group~   "
64211|NCT02216838|"~     The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat~     facial flushing.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
64212|NCT02216825|"~     Background: In recent years, probiotics have shown promise in treating a variety of~     diseases. Previously, the investigators have reported on the clinical efficacy of bile salt~     hydrolase active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in~     hypercholesterolemic adults.~      Objective: The purpose of the study is to investigate the effect of a delayed release or~     standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over~     a 4 week period, on the plasma bile acid profile.~      Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The~     study will last a total of 6 weeks, including a 4-week intervention period and a 2-week~     washout period.~   "
64213|NCT02216812|"~     The reported prevalence of disproportionate pain and disability among patients recovering~     from a fracture of the distal radius varies widely. Literature reports numbers between 1%~     and 37%, perhaps in part because it is poorly defined, known by so many different names,~     subjective, and unverifiable.~      The investigators are interested in the effect of vitamin C after distal radius fractures on~     objective measurement of finger motion, patient reported outcome measures, and pain~     intensity, instead of the previously used, subjective and imprecise criteria for complex~     regional pain syndrome.~      Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius~     fracture will be asked to participate in this clinical trial. Patient will be randomly~     assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as~     regarded by the treating physician at follow-up or for 6 weeks.~      The investigators hypothesize no difference in finger stiffness at 6 weeks measured by~     distance to palmar crease of the index through little finger between patients taking vitamin~     C or placebo after a distal radius fracture. Additionally, the investigators assess finger~     stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper~     extremity function and pain score both measured at six months.~   "
64214|NCT02216799|"~     Hyperglycemia increases the risk of complications in surgical patients. Focus on poor~     glycemic control as a contributor to adverse outcomes in settings outside the intensive care~     unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing~     surgical patients with nutrition to prevent deterioration of nutritional status. However,~     many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires~     frequent insulin administration via sliding scale. Providing diabetic patient's receiving~     TPN basal insulin is a known strategy to aid in blood sugar control and prevention of high~     blood sugar spikes. Many strategies for basal insulin provision have been utilized~     clinically during the administration of TPN; this includes the incorporation of insulin with~     TPN solution or administration of long acting insulin such as glargine. However, no study~     has compared any of these strategies aiming for selecting the optimum modality for~     controlling blood glucose in diabetic surgical patient's receiving TPN. We will conduct a~     study to compare the efficacy of once daily insulin glargine versus continuous regular~     insulin incorporated TPN in controlling blood glucose in non-critically ill diabetic~     surgical patients receiving TPN.~   "
64215|NCT02216786|"~     This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014~     versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive,~     HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment~     with (or within 12 months after discontinuation of) an AI in the adjuvant setting or~     progressed during treatment with an AI in the metastatic setting. Patients will be~     randomised (2:3:3:2) to one of the four treatment arms:~        -  Fulvestrant~        -  Fulvestrant + AZD2014 (continuous daily schedule)~        -  Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off)~        -  Fulvestrant + everolimus~      Randomization will be stratified by the following criteria:~        -  Measurable disease (vs. non-measurable).~        -  Sensitivity to prior endocrine therapy (sensitive versus resistant)~   "
64216|NCT02216773|"~     The aim of this study is to compare two different techniques (portal vein embolization and~     radiofrequency assisted liver partition with portal vein ligation) for increasing liver~     volume prior to major liver resection.~   "
64224|NCT02216669|"~     This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an~     oral dual drug with two mechanisms of action:~        1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the~          sulfamide components~        2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety~      The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3~     design first as single agent then combined with radiotherapy:~        1. A single agent dose-escalation phase in patients with solid tumours.~        2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy~      The main objective is to determine the recommended phase II dose of DTP348 in combination~     with radiotherapy~   "
64225|NCT02216656|"~     This randomized, placebo-controlled, double-blind (included open arm of KRN1493~     (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and~     safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally~     administered for three weeks for secondary hyperparathyroidism patients receiving~     hemodialysis.~   "
64217|NCT02216760|"~     The heart beat is controlled by electrical signals. Following a heart attack, part of the~     heart muscle dies and is later replaced by scar tissue. Within this area of scar, there~     often remain channels of surviving tissue still able to transmit electrical signals.~     However, it is well established that these conduction channels (CC) can form a short~     circuit around the scar, leading to electrical disturbances (arrhythmias) that are~     potentially life threatening. The commonest of these is ventricular tachycardia (VT), and is~     estimated to cause 300,000 deaths per year.~      One recognised treatment option of VT involves burning (ablation) these conduction~     channels (CC) within the scar. However, at present, the procedure is long and is far off~     100% effective. Consequently, current best practice does not rely on treating the VT, but~     rather preventing it from causing sudden death - this is achieved with an Implantable~     Cardioverter Defibrillator (ICD), a device which can recognise when a patient is in VT and~     deliver an internal shock to restore the normal electrical conduction. Patients with~     defibrillators subsequently are subject to recurrent painful and debilitating shocks which,~     although lifesaving, significantly reduce their quality of life. The limitation with~     ablation at present is due to the difficulty in visualising these CC's.~      Investigators at Imperial College have created a novel electrogram visualisation program,~     Ripple Mapping (RM), which they have already found to be superior to currently used~     programmes in cases of arrhythmias in the upper chambers of the heart (the atria). During a~     retrospective study in patients with scar related VT following a heart attack, when ablation~     was delivered in areas associated with identified Ripple Mapping Conduction Channels, these~     patients remained free of VT recurrence for >2 year follow up interval.~      The study hypothesis is that Ripple Mapping can identify all conduction channels within scar~     tissue critical to the VT circuit, ablation of which will lead to long-term freedom from VT~     and ICD therapies. The investigators now aim to perform a prospective randomised study~     comparing Ripple Mapping guided VT ablation against conventional VT ablation.~   "
64218|NCT02216747|"~     Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood.~     conventional treatment is steroid treatment and nearly 90% response to this treatment well.~      Response to this treatment is the most important prognostic factor and this patients has a~     benign disease course.~      60-70% among patients that response to steroid treatment,will suffer a relapse of~     NS.repeated steroids courses can lead to serious adverse events in children such as low bone~     density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is~     side effect corelation between steroid dose and treatment duration.~      guidelines for steroid dose for NS relapse are not based on retrospective clinical research~     but only on Nephrologists and experts opinion.~      Rational- What would be the optimal low dose steroids and the shortest time of treatment in~     Nephrotic syndrome relapse?~   "
64219|NCT02216734|"~     The investigators hypothesize that a strategy of establishing facility-based mother support~     groups (MSGs) for HIV-positive mothers will result in increased retention rates of~     HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery~     compared to clinics that lack MSGs. The study will be conducted in health facilities in~     rural Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster~     controlled study design will be used in 30 rural clinics randomly assigned to either arm to~     compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst~     arm 2 consists of standard of care together with facility-based MSGs.~   "
64220|NCT02216721|"~     Primary aldosteronism (PA) is a disorder of the adrenal gland causing an autonomous~     overproduction of mineralocorticoids, leading to arterial hypertension. Although rare, it is~     the most frequent cause of secondary hypertension. Early detection is important to avoid end~     organ damage, specifically cardiovascular and metabolic morbidity. Recent studies showed a~     positive correlation between patients with PA with lower bone density especially at the~     spine, with significant improvement post treatment, either medically or surgically. There~     was also a positive correlation between high aldosterone renin ratio with higher levels of~     intact parathyroid hormone (iPTH) which is responsible for cortical bone loss especially at~     the distal forearm.~      We hypothesize that our patients with PA have a higher level of iPTH, with lower bone~     density especially at the distal forearm, with improvement post treatment.~   "
64221|NCT02216708|"~     The recommendation for correction of dehydration of severely malnourished children with~     diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,~     in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart~     failure. There is not enough evidence to convince some of the physicians dealing with~     severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid~     rehydration per se is associated with increased incidence of over hydration and heart~     failure. And whether this approach is applicable in the management of severely malnourished~     children with severe cholera, which usually require rapid correction of water and~     electrolyte deficits for prevention of deaths due to hypovolaemic shock and other~     complications, has not been studied carefully. Recently, we have demonstrated that rapid~     intravenous rehydration (within 4 to 6 hours) of severely malnourished children with~     dehydrating cholera replacing appropriate amount of fluid was found to be safe. We feel that~     rapid rehydration would help in improving the renal function, acidosis and thus improve~     appetite and reduce ORS failure subsequently. Since our study was uncontrolled, so we have~     planned a randomised controlled study with adequate sample of 250 participants; 125 will be~     rehydrated slowly (over 10 to 12 hours) following WHO guideline and 125 patients will be~     rehydrated with intravenous fluid over 6 hours. Children of either gender, age 6 to 60~     months, severely malnourished (Wt for length <-3 Z score of WHO growth chart or with~     nutritional oedema) with a history of watery of <24 hours with signs severe dehydration~     attending the ICDDRB Dhaka hospital will be asked to participate in this study. After the~     parents'/Legal guardian's consent, the children will be transferred to the study ward and~     will be treated according to the protocol. All children will receive similar treatment~     except the mode of rehydration, different for the two groups. The children will be closely~     monitored throughout the study period. The primary outcomes incidence of over hydration and~     ORS failure and secondary outcomes improvement of renal function and improvement of appetite~     measured by the food intake will be compared between the groups.~   "
64222|NCT02216695|"~     The true population incidence of acute kidney injury (AKI), previously called acute renal~     failure, in England is not known. A better understanding of the epidemiology of AKI at a~     national level is essential to inform initiatives to prevent AKI as well as reduce the~     associated morbidity and mortality. The purpose of this study is to combine the national~     database of all hospital discharges with national census data to investigate trends in the~     incidence of both, AKI not requiring dialysis and AKI requiring dialysis, as well as its~     associated mortality and its determinants in England between 1998 and 2013~   "
64223|NCT02216682|"~     To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and~     consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement~     with spinal anesthesia.~      Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid~     consumption, a lower percentage of patients rescuing, or a longer time to first rescue with~     IV acetaminophen. The investigators will compare the efficacies of oral and intravenous~     acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.~   "
64234|NCT02216539|"~     Patients benefitting from a lung transplantation are subject to long-lasting and often~     severe post-operative pain. Self-hypnosis has been proven effective in the management of~     acute pain.~      The study hypothesis is that pre-operative training in self-hypnosis given to patients~     awaiting lung transplantation, will result in a reduction of post-operative pain one month~     after surgery.~   "
64226|NCT02216643|"~     Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a~     sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with~     stentriever and/or Thromboaspiration versus medical management alone. Randomization will be~     done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion~     site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to~     medical management alone in achieving more favorable outcomes in the distribution of the~     modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel~     ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase~     or have received IV alteplase therapy without recanalization. Sample size is projected to be~     690 patients for a difference in treatment effect of 10%.~   "
64227|NCT02216630|"~     This will be an open-label, non-randomized multi-center study designed to assess the safety~     and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of~     cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect~     the adipose tissue specimen for subsequent processing to isolate the stem cells.~   "
64228|NCT02216617|"~     The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib~     administrated in combination with docetaxel (Taxotere®) and cisplatin in induction~     chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,~     allowing the comparison with standard induction chemotherapy TPF.~      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib~     (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of~     docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of~     afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks~     treatment each one (9 weeks on the whole). The next dose level will be studied only if the~     previous dose is well tolerated for the period of the first 4 weeks observation of the~     treatment (1st cycle more first week of the 2nd cycle). Once the MTD is determined, four~     additional patients will be treated with this dose. A maximum of 22 patients should be~     included in this study. The total duration of the study is estimated at 18 months. In case~     of major safety problems, the study may be stopped earlier. In short, the preclinical data,~     pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be~     regarded as positive and that the association of afatinib with cisplatin and docetaxel could~     be effective in patients with head and neck squamous cell carcinoma potentially resulting in~     an extension of time to progression.~   "
64229|NCT02216604|"~     Today about 80% childhood cancer patients become long-time survivors. In spite of the high~     cure rates the diagnosis cancer is associated with a variety of disease and~     treatment-related psychological and physical impairments mostly present into adulthood. So~     the attention has to focus on the improvement of these problems such as motor limitation,~     dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis~     and diminished quality of life (Qol). Although exercisel intervention studies in this field~     are generally scarce, the results of these studies are promising. Up to now studies during~     the acute phase of treatment are missing almost completely. The aim of this feasibility~     study is to evaluate the potential benefits of a modular exercise intervention program for~     childhood cancer patients startunf in parallel with treatment and longlasting for one year.~     Across two years cancer patients of the Children's Hospital of the University Clinic of~     Heidelberg aged 5-21 years, free of any contraindications for physical activity will be~     recruited. All participants are asked to complete a physical assessment battery (strength,~     endurance and balance capacity, posture control, functional mobility, range of motion) and~     additionally two questionnaires concerning Qol and motivation, at baseline and every three~     months following one year~   "
64230|NCT02216591|"~     The proposed study will test the efficacy of a cognitive training program to improve working~     memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults~     with poor medication adherence to one of two conditions (20/group): the experimental~     cognitive training intervention or a control training condition. Participants will complete~     12 training sessions across 10 weeks and will complete assessments at baseline and~     post-training. The specific aims are to:~        1. Investigate the effects of the cognitive training intervention on working memory and~          delay discounting in HIV-infected persons.~           Hypothesis 1: Participants assigned to active cognitive training, compared to those in~          the attention-matched control group, will have greater improvements in working memory~          and reductions in delay discounting.~        2. Characterize adherence to antiretroviral medications in this population and examine~          medication adherence after cognitive training.~      Hypothesis 2: Participants assigned to active cognitive training, compared to those in the~     attention-matched control group, will have greater improvements in medication adherence.~   "
64231|NCT02216578|"~     The study is a multi-center, multi-national, open label, single arm Phase II study of~     single-agent cabozantinib. The objective of the study is to assess the safety and activity~     of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib~     and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase~     inhibitors.~      Patient will receive cabozantinib until they experience no further benefit from the~     treatment, becoming intolerant to the drug or wishing to discontinue the treatment.~     Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit~     upon investigator's discretion, provided no other criteria for treatment withdrawal are met.~   "
64232|NCT02216565|"~     This trial aims at comparing two strategies currently used to address acute ischemic stroke~     of the middle cerebral artery : medical treatment without endovascular treatment on the one~     hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of~     the strategies will be assessed in terms of early neurological clinical recovery.~      The study will focus on three particular situations : (1) tandem internal carotid and middle~     cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis~     because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended~     because of a delay superior to 4.5 hours.~      The hypothesis to be tested is that medical approach plus endovascular treatment is superior~     to medical treatment alone~   "
64233|NCT02216552|"~     The current project is designed as a 30-day pilot trial to demonstrate the safety and~     tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and~     improve insulin sensitivity to prevent type 2 diabetes.~   "
64235|NCT02216526|"~     Residents of institutional long-term care facilities are at high risk for developing skin~     and tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis,~     candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant~     melanoma) but there are few epidemiological figures about the actual frequencies of these~     conditions in nursing homes. Therefore, in the first part of this study we aim at measuring~     key dermatological conditions and associated health and functional status, and the skin care~     practice of aged nursing home residents (prevalence study).~      Basic skin care interventions are believed to reduce skin dryness and to enhance skin~     health. Thus, the second aim of this study is to investigate the effectiveness of two~     structured skin care regimens compared to the routine standard skin care on skin health in~     nursing home residents (intervention study).~      The study will be conducted in a random sample of seven out of approximately 300~     institutional long term care facilities of the federal state of Berlin.~   "
64236|NCT02216513|"~     The investigators will test the central hypothesis that DFO treatment after SAH may improve~     cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective~     neuroprotectant against delayed ischemic injury after SAH.~   "
64237|NCT02216500|"~     Approximately a fourth of children with seizures do not respond adequately to available~     therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but~     there is no agreement concerning how it works and what is the best way to administer it.~     This natural history study will collect data pertaining to both questions.~   "
64238|NCT02216487|"~     As an approach to improve efficacy and provide clinical benefit to cancer patients~     undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel~     means for delivering anti-cancer agents to tumours. The drug delivery platform is based on~     the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in~     optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific~     example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced~     efficacy in both nonclinical and early clinical studies.~      The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm~     trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild~     type metastatic colorectal cancer. The study objectives are to confirm the safety and~     efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic~     colorectal cancer patients.~      It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent~     treatment and follow up; thus the trial will run for approximately 2-3 years.~   "
64239|NCT02216474|"~     Brain stimulation in movement disorders~      This trial will explore the effects of very gentle electrical stimulation of the brain in~     patients with movement disorders. Other studies have already been carried out and have shown~     that brain stimulation may help to improve mental abilities and the symptoms of conditions~     such as depression and stroke. The investigators will show whether this method can help with~     symptoms such as memory and concentration problems in patients with movement disorder who~     have mild to moderate problems with these mental abilities. The investigators will also look~     at the effects of brain stimulation on movement symptoms and mood. These people will be~     compared to healthy people to help us understand whether brain stimulation works differently~     in healthy people and people with brain disorders.~      This trial is being carried out at one centre in Birmingham. It is scheduled to begin in~     September 2014 and will last for up to five years. As the study commences it is being funded~     by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The~     investigators plan to recruit up to a maximum of 200 individuals in this study.~   "
64240|NCT02216461|"~     To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated~     dosing~   "
64241|NCT02216448|"~     The purpose of this study is to compare between two groups of residents with basic~     arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee~     arthroscopic simulator in a lab, and the second group will perform diagnostic knee~     arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy~     surgeon in the operating room based on selected competencies following the Global Rating~     System.~   "
64242|NCT02216435|"~     Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,~     slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain~     Stimulation (DBS) is the FDA-approved method for patients who no longer get effective~     treatment from the best available medication. The location in the brain where the electrode~     is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study~     aims to investigate another location in the brain, the Substantia nigra pars reticulata or~     SNr. The SNr is also known to be involved in motor control of muscles and may be involved in~     the process by which the initiation of movement occurs.~   "
64243|NCT02216422|"~     This was a multicenter study evaluating the efficacy and safety of~     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12~     weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV~     treatment-experienced, cirrhotic HCV genotype 1b-infected adults.~   "
64244|NCT02216409|"~     The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in~     participants with solid tumors.~   "
64245|NCT02216396|"~     One third of the population, aged over 65, live and will die with dementia. Half of people~     with dementia experience symptoms of agitation every month. Symptoms of agitation include~     restlessness, pacing, shouting and verbal or physical aggression. Many people with agitation~     are admitted to care homes as families find they cannot care for them at home. Within the~     care home, staff also often find managing people with agitation difficult and they react in~     a wide range of ways. Agitated behaviour takes up staff time and emotional and physical~     energy but they do not always know how to respond. This study is one of the streams in an~     integrated programme to help tackle agitation in a variety of settings from domestic~     environments to end of life.~      Our primary hypothesis is that for people with dementia living in care homes, paid carer use~     of dysfunctional coping strategies predicts lower quality of life in residents with dementia~     and that this is more so at higher levels of agitation.~      We will recruit 60-80 care homes (residential or nursing homes). We will identify all~     residents with dementia, and the care home manager will approach them and their family~     carers. After obtaining informed consent, or advice from personal or nominated consultees~     for those lacking capacity, we will ask people with dementia who can answer questions about~     their quality of life using the DEMQOL. We will also ask staff and their family carers for~     those who have them, to rate the quality of life of the person with dementia using the~     DEMQOLproxy. We will ask care home staff other questions about residents with dementia,~     including about agitation, using the Cohen-Mansfield Agitation Inventory (CMAI), and the~     care they receive. Staff will also answer questions about the ways they cope with caring~     stresses, using the COPE. We will measure quality of life and agitation 5 times over 16~     months. We will use our results to test our theory that agitation is an important factor~     determining residents quality of life, and that the ways staff cope with stress affect the~     impact agitation has on quality of life.~   "
64246|NCT02216383|"~     BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due~     to excessive bleeding after the birth of the baby and placenta, or post-partum haemorrhage~     (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely~     frightening for women and can cause them to need additional treatments including blood~     transfusion and removal of the womb as well as prolonging their hospital stay.~      The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the~     mother an injection of uterotonic medicine following the birth of their baby can prevent~     this. It reduces the risk of PPH by 66% and this should routinely be offered to all~     labouring women.~      In the UK, the two medicines most commonly used for this purpose are Syntocinon and~     Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published~     review of trials comparing these two medicines concluded that Syntometrine is no better at~     preventing severe blood loss. Syntometrine is associated with more side effects including~     nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases~     of stroke. All guidelines therefore recommend Syntocinon for preventing PPH.~      Our group conducted a telephone survey of all maternity units in the UK, and found that~     71.4% of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000~     women per year are experiencing distressing nausea and vomiting in the emotionally important~     first few hours following childbirth. These women are also receiving a medicine with the~     potential to cause dangerous high blood pressure.~      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet~     after vaginal birth. Other studies have shown that Carbetocin is slightly better at~     preventing bleeding after birth when compared to Syntometrine, that it has fewer side~     effects than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH.~     No studies have directly compared all three medicines or compared their overall cost;~     information vital to the NHS.~      METHOD Investigators propose a trial of 6285 women over 13 months, in four maternity units~     in the South-West to compare the effectiveness, side effects and cost of Syntocinon,~     Syntometrine and Carbetocin, for women having a vaginal birth.~      Women will be randomly allocated to receive one of these drugs. Women and staff will not~     know which drug they receive, so as not to influence the results collected. Staff will~     collect data such as the number of extra drugs and treatments needed and the volume of blood~     lost. Women will be asked to complete a side effects questionnaire. Investigators will~     perform an analysis of cost effectiveness once all results are available.~      AIMS Investigators aim to establish whether Carbetocin is an effective and affordable~     alternative to Syntocinon and Syntometrine, and whether it has fewer side effects for new~     mothers. Publication of our results, regardless of what they find, could potentially improve~     the birth experience of women across the UK, and support the health service in spending its~     money most effectively.~   "
64250|NCT02216331|"~     This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will~     examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects~     will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will~     examine the effects of repeated doses of either rifapentine or rifampicin on TMC207~     pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22~     daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day~     41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be~     confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study~     Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine~     whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax~     and AUC(0-t) to a lesser degree than rifampicin.~   "
64251|NCT02216318|"~     to investigate the effect of two lightning conditions on sleep hypothesizing that sleep~     length is influenced by the color of light during daytime~   "
64252|NCT02216305|"~     HYPOTHESIS~        1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision~          hemorrhoidectomy.~        2. HAL - RAR achieves similar immediate and long term results compared to the excision~          hemorrhoidectomy in the control of hemorrhoidal symptoms.~        3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.~      OBJECTIVES~        1. Compare postoperative pain of both techniques.~        2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique,~          and compare the results with those of the excision hemorrhoidectomy.~        3. Evaluate and compare the rate of complications of both techniques.~        4. Assess the quality of life of patients before and after treatment.~      MATERIAL AND METHODS~      The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació~     Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).~      All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with~     both methods who agree to participate in the study, will be included in the prospective~     randomized trial. All patients will be required to sign the specific informed consent.~      Patients who are suitable for treatment with both techniques will be randomly assigned to~     the surgical technique.~      Inclusion criteria:~      1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling~     or prolapse) that are eligible for surgical treatment with both methods.~      Exclusion criteria:~        1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,~          perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal~          stenosis.~        2. Prior anorectal surgery .~        3. Systemic pathology that could alter the outcome of the surgery as coagulopathies,~          chronic pain with continued consumption of analgesics.~        4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand~          the study objectives.~      All surgeries are performed on an outpatient basis under regional anesthesia and sedation~     for the same team of three surgeons. Preoperative preparation consists of a cleansing enema~     and no prophylactic antibiotics will be administered.~      Both techniques will be performed in Jack -Knife position. The open hemorrhoidectomy may~     include one to three anal cushions and made according to the Milligan-Morgan technique, with~     resection of the anal cushion and the external hemorrhoidal epidermal component using~     electrocautery and ligation of the hemorroidal base with absorbable suture. Once completed~     hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.~      Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally~     invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the~     superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the~     blood flow approximately 3 cm above the dentate line by using Doppler guidance.~     Subsequently, a running suture was added from the suture point to 5 mm above the dentate~     line to lift the prolapsing hemorroid. Other procedures will not be associated, if~     necessary, the patient will be excluded from the study .~      The patient will be discharged if adequate pain control, oral tolerance and spontaneous~     diuresis is achieved, and after examination by the surgeon in order to discard immediate~     complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide~     ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen~     (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case~     of persistent pain, the patient will be examinated in emergency room.~      EVALUATION OF RESULTS A power analysis was performed to assess the study sample size.~     Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that~     26 patients were needed in each arm. We increased this number up to 30 to increase~     reliability of the study.~      All patients will be evaluated with a validated questionnaire of 36 questions on quality of~     life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain,~     itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be~     answered before the intervention, after six and twelve months of follow up.~      All patients will complete a diary testing global postoperative pain every day, measured on~     a numerical scale from 0 to 10 during the first 15 days.~      The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative~     days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient~     clinic.~   "
64253|NCT02216292|"~     Human milk is the best source of enteral nutrition for the preterm infant. However during~     the infants first hours and days of life breastmilk from the own mother is usually not~     available. Until May 2012 the practice in the Neonatal Division of the Department of~     Pediatrics /Medical University Vienna was to start with formula feedings within the first 6~     hours of life of a premature infant and switch over to breastmilk as soon it was available.~     In June 2012 the investigators changed this feeding regimen and started to use single donor~     milk of mothers of preterm infants for the first hours and days of the preterm infants life.~     In a prospective observational study the investigators evaluated the impact of single donor~     milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and~     NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below~     32 weeks. Data will be compared with a historical control group starting with preterm~     formula as source of enteral nutrition. The investigators hypothesize that starting enteral~     nutrition with single donor milk of mothers from preterm infants with shorten time to full~     enteral feedings.~   "
64254|NCT02216279|"~     Pulmonary hypertension or elevation of the pressure in the pulmonary vessels, results from~     various clinical conditions. It may be idiopathic (of unknown cause) or associated with~     numerous diseases including cardiovascular and lung disorders. Affected individuals suffer~     from progressive shortness of breath and, in its most sever forms; pulmonary hypertension~     carries a worse prognosis than many types of cancer. There is no test currently that can~     easily and non-invasively detect abnormalities of the pulmonary circulation. Presently there~     is no cure for pulmonary hypertension and substantial research efforts are dedicated to the~     development of new drugs that will stop progression or better yet, reverse the disease~     process. The investigators do not know if any of the drugs currently commercialized for~     pulmonary hypertension directly improve the status of the pulmonary vessels since no test~     currently provides this information. Direct earlier detection of lung vessel abnormalities~     associated with pulmonary hypertension using a sensitive and non-invasive test would allow~     not only earlier testing of these and of new drugs, but would provide a much better~     surrogate of disease severity allowing more efficient pre-clinical drug testing. The aim of~     this phase II study is to evaluate the safety of PulmoBind in participants with pulmonary~     hypertension and its potential to detect abnormal pulmonary circulation associated within~     pulmonary hypertension.~   "
64255|NCT02216266|"~     Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in~     Intensive care after a surgery~   "
64256|NCT02216253|"~     This study will include women who will undergo pelvic reconstructive surgery and/or~     anti-incontinence sling procedures. Patients will be randomized to the combination of~     L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a~     day during the seven days before and after surgery (total of 14 days). In this randomized,~     double-blind study, the investigators will assess treatment of clinically suspected or~     culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and~     risk factors for treatment for postoperative urinary tract infections (secondary outcomes)~     between the two study groups.~   "
64257|NCT02216240|"~     Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half~     of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular~     SVT's are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry~     tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry~     tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT~     can cause unpleasant symptoms and are frightening it is not dangerous. If patients present~     with AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm~     stopped by either taking a deep breath and straining or by the use of drugs. Patients can~     then be discharged home and have further investigation and treatment as an outpatient. SVT~     can be frightening for the patient but is easy to diagnose and treat. There is high success~     rate post treatment for this benign condition. This is traditionally done in the local~     accident and emergency, although patients can sometimes be unnecessarily admitted to~     hospital overnight. We propose to investigate the safety and efficacy of training paramedics~     to treat safe forms of AV(N)RT at the scene and then giving the patient an information pack~     which includes a request for a GP referral to a heart rhythm specialist. Patients will be~     randomly allocated after consenting to take part in the study to either get paramedic or~     accident and emergency department treatment. We will compare these two approaches by~     telephone follow up of the patients. The costs of the different approaches will be compared~     by assessing the rate of appropriate investigation and the information given to patients and~     how they rated their experiences.~   "
64258|NCT02216227|"~     The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the~     checklist to prevent MRSA SSIs among veterans undergoing TJA or cardiac surgery, and 2) to~     assess barriers and facilitators to checklist implementation.~      Hypotheses:~        1. The SSI checklist will be effective at reducing MRSA SSIs among total joint~          arthroplasty and cardiac surgery patients.~        2. Implementation of the checklist will be associated with an overall reduction in SSIs~          caused by all pathogens.~        3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.~        4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI~          checklist.~   "
64260|NCT02216201|"~     The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical~     device for the the determination of sweat gland function in the pediatric population.~      Primary Objective: To measure sweat gland function in a pediatric population~      Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland~     function in the pediatric population~   "
64261|NCT02216188|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE®~     PD01A vaccinations in patients with Parkinson's disease. Patients, who have already~     participated in AFF008 will be involved and will be receive one boost immunization with~     AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.~      In addition, up to 8 patients will be offered participation within an untreated control~     group.~   "
64262|NCT02216175|"~     Allergy to cow's milk is the most common food allergy affecting children. There is currently~     no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted~     to induce desensitisation using small daily doses of cow's milk, predominantly by the oral~     route (oral immunotherapy, OIT). Although this therapy works for some people, its effects~     are not generally long lasting and it is associated with significant side effects during~     protocol, including potentially life-threatening allergic reactions.~      Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the~     tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer~     adverse events. However, the degree of desensitisation induced appears to be lower than that~     with oral immunotherapy.~      The investigators wish to determine whether a sublingual pretreatment phase can improve the~     safety of conventional OIT in cow's milk allergy.~   "
64263|NCT02216162|"~     PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric~     intervention on treatment compliance, measured regularly by blood dosing of drug~     metabolites.~      Patients in the intervention group will be proposed:~        -  A regular geriatric follow up including an attentive screening of joint symptoms and~          functionality,~        -  An adapted treatment of join pain,~        -  Weekly sessions of adapted physical activity (Taï Chi),~        -  And a systematic correction of vitamin D deficits.~   "
64264|NCT02216149|"~     Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are~     occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is~     infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less~     frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head~     comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical~     coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow~     response to a cold pressor test, in a patient population who are being treated for~     adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens,~     either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.~   "
64265|NCT02216136|"~     This is an observational study of 3 arms: breast conservation therapy (Group A), mastectomy~     and reconstruction (Group B), and mastectomy only (Group C).~   "
64266|NCT02216123|"~     This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total~     of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female~     subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD)~     deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear~     that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive~     tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects~     will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1~     or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will~     receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is~     180 days, including screening and randomization to treatment (Day 1), three in-hospital days~     (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11~     and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180).~      The primary safety data collected in this study will help to understand the hemolysis risk~     to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study~     will support the results for sister study TAF112582, the pivotal phase III efficacy and~     safety study of the TQ program.~   "
64267|NCT02216110|"~     Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic~     submucosal dissection (ESD) has been accepted as standard treatment in selected patients~     with negligible risk of lymph node metastasis. However, there are limited data regarding the~     long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall~     survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.~   "
64268|NCT02216097|"~     The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a~     well-established neuroimaging paradigm including behavioral tasks selected to activate~     neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that~     PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance~     Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress~     Disorder.~   "
64269|NCT02216084|"~     The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter,~     dose-escalation study is to evaluate the safety, including immunogenicity, and~     pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with~     severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%)~     who are assigned to one of three dose cohorts.~   "
64270|NCT02216071|"~     The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL~     CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic~     Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when~     administered twice daily for 7 days.~   "
64271|NCT02216058|"~     A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA~     CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.~   "
64272|NCT02216045|"~     Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this~     study is to evaluate effectiveness and safety of camel milk in combination with~     Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .~   "
65419|NCT02201069|"~     The My Health Coach Study seeks to determine if health coaching by a medical assistant can~     help patients have better sleep, a better diet, be more physically active or lose weight,~     according to the recommendation of their health care provider.~   "
64273|NCT02216032|"~     Thirty Million Words Home Visiting: A Longitudinal RCT is a longitudinal, randomized control~     trial, which is required to confirm whether the parent behavior changes seen during the~     feasibility trial are sustainable, and, critically, whether those changes translate into~     positive impacts on child language outcomes, child social-emotional development, and~     subsequent school readiness. The investigators will deliver the Thirty Million Words (TMW)~     Curriculum to 100 Treatment families, and the investigators will be following the children~     through kindergarten in order to measure the effects and sustainability of the curriculum.~     The investigators will deliver a Nutrition Curriculum to 100 Control families in order to~     control for the possible attentional effects experienced by those in the Treatment group.~     Moreover, as an ethical consideration, the investigators wish to also provide families in~     the Control condition with valuable education that may enhance their children's development.~      The investigators hypothesize that the primary effects of the TMW Intervention will~     significantly 1) improve low-SES parents' understanding of the importance of parent language~     in a child's development, 2) increase parents' linguistic interaction, responsiveness, and~     overall engagement with their children, and 3) increase children's language output.~     Furthermore, the investigators hypothesize that increased parental interaction will result~     in 4) an improvement in children's social-emotional development. Finally, the investigators~     hypothesize that these social-emotional and linguistic gains through early development,~     along with sustained increased parental engagement, will be expressed in 5) increased child~     school readiness upon kindergarten entry.~   "
64274|NCT02216019|"~     In septic patients, Septiflux1 study identified immature granulocytes which may have a~     diagnostic and prognostic interest. However, with these preliminary results it is not~     possible to make a difference between what is linked to the infection and what is a~     consequence of the inflammation which goes along with the septic process. Using flow~     cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary~     bypass in heart surgery could make possible to test the diagnostic interest of the immature~     granulocytes but also to attribute a prognostic value for the occurrence of post-operative~     infections.~   "
64275|NCT02216006|"~     Atelectasis is common during and after general anesthesia. Atelectasis develops early if~     preoxygenation with 100% oxygen is used and continuously used during induction until~     endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation~     maneuver immediately after confirming a successful intubation, reduces the area of~     atelectasis as investigated by computed tomography compared to a standard procedure.~   "
64276|NCT02215993|"~     Introduction:~      Platelet aggregation plays an important role in ischemic complications in patients~     undergoing to percutaneous coronary intervention (PCI). The addition of clopidogrel, as a~     second antiplatelet agent, to acetylsalicylic acid (ASA) was effective in reducing major~     cardiovascular events in patients with acute coronary syndrome (ACS).~      However, approximately 30% of ACS patients are resistant to clopidogrel, representing a~     population of medically vulnerable and high risk for major cardiovascular events, including~     myocardial infarction (MI), stent thrombosis and death.~      In the randomized trial TRITON, prasugrel compared to clopidogrel was more effective in~     significantly reducing the rates of MI (7.4% vs. 9.4%) and stent thrombosis (2.4% vs .1,1%)~     in patients with ACS, however, patients treated with prasugrel showed higher rates of~     bleeding (2.4 vs. 1.8%) and no difference in mortality. Upon analysis of subgroups is not~     recommended its use in patients with a history of stroke in those older than 75 years and~     weighing less than 60 kg.~      The latest class of inhibitors of the P2Y12 receptor is the cyclopentyl-triazolopyrimidines~     represented by ticagrelor. Unlike the thienopyridines, ticagrelor interacts with the~     platelet receptors in a reversible way and has a beginning and peak of action faster.~      The efficacy and safety of ticagrelor were evaluated in the study PLATO, where 18.624~     patients with ACS were randomized to receive clopidogrel (75mg/day, with a loading dose of~     300 to 600mg) or ticagrelor (90mg 2x/day with a loading dose of 180mg) The primary combined~     endpoint (mortality from vascular causes, MI or stroke) at 12 months was significantly lower~     in the ticagrelor (9.8% vs. 11.7%). There was no significant difference in the rates of~     major bleeding in both groups. Moreover, the isolated analysis of the rates of MI, vascular~     mortality and mortality from all causes showed statistically significant reduction in the~     ticagrelor users. In this study, the main adverse effects were dyspnea and bradycardia.~      The assessment of platelet reactivity may allow the individualization of antiplatelet~     therapy. However, simply increasing the dose of clopidogrel in patients who persisted with~     high platelet reactivity was not able to reduce the combined endpoint of cardiovascular~     death, nonfatal myocardial infarction and stent thrombosis in six months.~      In a population of patients with stable coronary artery disease, the substitution of~     clopidogrel for ticagrelor showed a rapid and persistent decrease in platelet aggregation~     measured by different laboratory methods. However, in patients with ACS subjected to PCI,~     the assessment of platelet aggregation after the replacement of clopidogrel for prasugrel or~     ticagrelor still requires evidence.~      Objectives:~      To evaluate the platelet response to ticagrelor and prasugrel in ACS patients with~     ST-segment elevation submitted to thrombolysis.~      To evaluate security in follow up of 30 days.~      Methods:~      The study will be a prospective, randomized, single-center (São Paulo Hospital - Federal~     University of São Paulo), single-blind. The investigators will select 50 patients admitted~     with ACS with ST-segment elevation submitted to thrombolysis and who underwent cardiac~     catheterization between 3 to 24 hours in the case of reperfusion or immediately for rescue~     angioplasty. Blood sample for analysis of platelet aggregation through the system VerifyNow~     ®, shall be obtained immediately after the procedure on patients on clopidogrel for at least~     seven days in maintenance dose of 75mg or after 8 to 6 hours after the dose of 300mg and~     600mg respectively. Patients will be randomized in a 1:1 ratio to receive ticagrelor the~     dose of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of~     60mg and maintained for thirty days at a daily dose of 10mg. A new blood sample and analysis~     of platelet aggregation will be repeated after 2, 6 and 24 hours. The demographic and~     clinical data of this population will be collected in specific form and stored in databases~     for later analysis~   "
64277|NCT02215980|"~     This protocol is a phase III multicenter, randomized, controlled study designed to assess~     the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in~     elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus~     steroids.~   "
64278|NCT02215967|"~     Background:~      - T cells are white blood cells that fight several cancers. One cancer therapy involves~     removing a person s T cells, changing them in a lab, and then returning them to the person.~     Researchers want to see if this helps people with multiple myeloma.~      Objective:~      - To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with~     multiple myeloma.~      Eligibility:~      - Adults ages 18 70 with multiple myeloma that has not responded to standard therapies.~      Design:~        -  Participants may be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart tests~        -  Bone marrow sample~        -  Multiple scans and X-rays~        -  Participants will have apheresis. Blood is removed through a needle in an arm. T cells~          are removed. The rest of the blood is returned through a needle in the other arm.~        -  The cells will be changed in a laboratory.~        -  Participants will get 2 chemotherapy drugs over 3 days.~        -  Two days later, participants will check into the hospital. They will get an intravenous~          (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1~          infusion.~        -  After this, participants will stay in the hospital for at least 9 days and stay nearby~          for 2 weeks. Then they will have blood tests and see a doctor.~        -  Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion,~          then every 6 months. A bone marrow sample will be taken at the 2-month visit.~        -  Participants blood will be collected for several years. Participants will have an~          annual physical at NIH for 5 years after the infusion. Then for 10 years they will~          answer health questionnaires.~   "
64279|NCT02215954|"~     To demonstrate non inferiority of a) FE 999169 Split Dosing Schedule (one dose on the day~     before and the second dose on the day of colonoscopy) and b) FE 999169 Day Before Dosing~     Schedule (two doses on the day before colonoscopy) to  Niflec On the Day Dosing Schedule~     in subjects requiring colonoscopy.~   "
64280|NCT02215941|"~     The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in~     plasma following single and multiple-dose topical application of 8% TV-45070 ointment.~   "
64281|NCT02215928|"~     This research trial studies using genomic profiling to recommend anticancer treatment to~     patients with cancer that has spread beyond the original site of the tumor (metastatic~     cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect~     genetic changes or abnormalities. This information can then be used to recommend treatments~     that may be more likely to result in a beneficial response. It is not yet known whether~     genomic profiling will detect abnormalities that can be used to make treatment~     recommendations and whether treatment based on genomic profiling is more effective than~     standard treatment.~   "
64282|NCT02215915|"~     A number of 1330 patients scheduled for elective percutaneous coronary intervention (PCI)~     with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly~     randomized 1:1 to either IVUS guidance or angiographic guidance groups.~   "
64283|NCT02215902|"~     Primary Objectives:~      To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood~     purification.~      Secondary Objectives:~      To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the~     first and last Hemopurifier treatments using elution methods developed by Aethlon Medical~     Inc.~      To measure changes in viral load in patients before and after treatment with the Aethlon~     Hemopurifier®.~   "
65420|NCT02201056|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-935~     in healthy participants when administered as a single dose of oral solution at escalating~     dose levels.~   "
64284|NCT02215889|"~     The patients will receive hepatectomy as a 2 stage procedure. In the first surgical~     procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth~     of donor segments 2-3, the remaining liver segments of the recipient are removed. The~     patient will at this time have only donor liver tissue in place.~   "
64285|NCT02215876|"~     This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in~     patients with operable, HER2-negative, breast cancer.~   "
64286|NCT02215863|"~     Recent reviews have highlighted the unpredictability and complexity of immune interference~     when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It~     has become evident that the likelihood of immune interference (in response to conjugated- or~     co-administered antigens) increases in proportional to the number of glyco-conjugates~     (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins:~     tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex~     outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus~     influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity,~     but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell~     dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but~     apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13~     co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat~     reduced compared to the results with PCV13 alone.~      Similar to children, adults frequently visit outpatient clinics to get two or more kinds of~     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and~     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster~     vaccine, etc. PCV13 has limited co-administration information for adjuvanted influenza~     vaccine.~      This study is designed to evaluate the immunogenicity and safety of PCV13 and~     MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60~     years or older.~   "
64287|NCT02215850|"~     SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in~     development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane~     metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its~     expression is highly restricted in normal tissue. CAIX is a functional regulator of~     processes critical for tumour growth and metastasis, including pH regulation, survival,~     migration and invasion.~      This prospective single arm study will evaluate the safety of SLC-0111 given once daily in~     28 day cycles in subjects with advanced solid tumours. The intent of this research study is~     to find our more information such as: the highest dose of SLC-0111 that can be given safely,~     the side effect it may cause, to examine how the body affects the study drug concentration~     in the blood (pharmacokinetics or PK), and to gain some information on its effectiveness in~     treating cancer.~   "
64288|NCT02215837|"~     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined~     with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK)~     for gastric cancer.~   "
64289|NCT02215824|"~     The primary aim of this trial was to investigate the safety of a 6 hour intraarterial~     infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive~     disease (PAOD) and chronic Critical Limb Ischaemia (Fontaine class III or IV).~   "
64290|NCT02215811|"~     This is a multi-center, open-label, non-randomized controlled trial. Patients with~     viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane~     oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic~     bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as~     preoperative clinical characteristics and postoperative clinical outcomes will be~     registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be~     performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute~     walk test will be performed postoperatively. All available data will be collected~     prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to~     patients meeting the inclusion criteria before the initiation of any study-specific~     procedures.~   "
64291|NCT02215798|"~     Primary objective: To estimate the frequency of adverse events, serious and non-serious in~     Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg~     once daily within the study duration of approximately 6-8 weeks in a naturalistic clinical~     setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief~     Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators~     in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino~     patients within the study duration of approximately 6-8 weeks in a naturalistic clinical~     setting.~   "
64292|NCT02215785|"~     Constipation is a symptom suffered by a large number of people, due to multifactorial~     causes. Some studies have proven that modifying lifestyle reduces the risk of constipation,~     with high-fibre diets being less prone to constipation. Kiwifruit consumption, improves~     functional constipation and some studies consistently report an increase in the frequency~     and ease of defecation, stool volume and softness.~      Although literature suggests kiwifruit consumption improves constipation symptoms, no~     studies have been carried out in adults and in Mediterranean patient populations,~     characteristic for its differential nutritional habits. The aim of the present study was to~     test the effect of kiwifruit consumption on functional constipation in a Spanish adult~     population.~   "
64293|NCT02215772|"~     Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,~     and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a~     single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to~     evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI~     44370 BS to healthy male volunteers~   "
64294|NCT02215759|"~     Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI~     44370 TA in healthy male and female volunteers~   "
64295|NCT02215746|"~     The objective of this trial was to evaluate the relative oral bioavailability and~     pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA~     tablets (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the~     safety and tolerability of the substances.~   "
72151|NCT02112968|"~     This clinical study has been planned to evaluate the safety and effectiveness of common~     treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and~     Presbyopia~   "
64296|NCT02215733|"~     The primary objective of this study was to assess whether angiotensin blockers (ARBs) and~     telmisartan in particular, are associated with an increased overall risk of the four most~     common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective~     was to explore these effects separately for each of the four cancers and in combination with~     angiotensin-converting-enzyme-inhibitors (ACEIs).~   "
64297|NCT02215720|"~     Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal~     cancer or head and neck cancer in several phase II/III studies.~      Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase~     I/II studies in advance kidney cancer of bad prognosis.~      Study hypothesis is that combination of those two compounds and the inhibition of two~     pathways at the same time will have more efficiency on tumoral growth than the inhibition of~     those pathways in isolation.~   "
64298|NCT02215707|"~     This is an open-label evaluation of the safety, tolerability immunogenicity and efficacy of~     the PfSPZ Vaccine administered by Direct Venous Inoculation (DVI) in healthy, malaria-naïve~     subjects. There will be 3 groups and a total of 69 subjects (45 immunized subjects and 24~     infectivity controls).~   "
64299|NCT02215694|"~     The purpose of this study is to evaluate the effect of dual probiotic strains containing~     Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and~     apolipoprotein A-V.~   "
64300|NCT02215681|"~     Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media~     with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are~     in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control.~     50 Children in the acupuncture group will receive standard treatment combined with~     acupuncture for 3 months. 50 Children in the control group will receive standard treatment~     only, for the same time period. After 3 months, both groups will be reassessed for OME.~     Children with no improvement from both groups will be assigned for tympanostomy.~      Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be~     collected, analyzed and evaluated for group differences.~   "
64301|NCT02215668|"~     Mammography is a systematic way in the main programs of screening for breast cancer in women~     over 40 or 50 years old, according to screening programs, but most research has shown a~     frequency of discomfort and pain during the examination mammography. This study is a~     randomized controlled trial, whose intervention will be a sequence of exercises body warming~     and muscle stretching, performed systematic manner and supervised by a physical educator. It~     is expected to find in this study a possible impact of physical exercise in reducing pain~     after mammography examination.~   "
64302|NCT02215655|"~     Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk~     factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as~     high as 74% in ESRD patients and has been shown to be most related to psychosocial factors~     including attitudes. There is limited data on the influence of attitudes and perceived~     autonomy support on phosphate binder adherence and these two psychosocial constructs can be~     positively influenced through the use of motivational interviewing skills to increase~     autonomous motivation. Furthermore, racial disparities are known to exist in ESRD however~     and there are still gaps, which exist in understanding the determinants of disparities in~     adherence in vulnerable patients with ESRD.~      In this study, the investigators seek to determine the impact of motivational interviewing~     on phosphate binder adherence in diverse ESRD patients. The investigators will ask all the~     subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy~     support and phosphate binder adherence. The investigators will administer motivational~     counseling to subjects in the intervention arm of the study, at baseline and 1 month after~     recruitment. The investigators will ask all the subjects to fill out the same surveys 2~     months after recruitment and the investigators will compare subjects who underwent~     motivational interviewing to those who did not.~   "
64303|NCT02215642|"~     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports~     concluded nutrition status and lifestyle factors were associated with colorectal cancer~     risk, however, the influence of nutrition and lifestyle factors on cancer outcome in~     colorectal cancer survivors is largely unknown.The investigators will explore the impact of~     nutrition status, life style, dietary pattern, obesity, physical activity, depression,~     diabetes, aspirin use and vitamin supplement on colorectal cancer outcome. The investigators~     will recruit approximately 50,000 patients as a prospective study cohort. During follow up,~     the investigators will explore the association of these factors with disease-specific~     survival, disease-free survival and overall survival of patients. The investigators believe~     that this project will facilitate the establishment of domestic nutrition and lifestyle data~     of colorectal cancer of China, and the improvement of the quality of clinical management of~     patients with colorectal cancer.~   "
64304|NCT02215629|"~     The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of~     leukemia patients and to find the right dose of VS-4718 for future clinical trials.~      Other purposes of this study include:~        -  Testing for study drug VS-4718 levels in blood over time and what happens to the study~          drug in patients.~        -  To find out if there are certain biomarkers in leukemia patients that predict if and~          how 4718 study drug may or may not work.~   "
64305|NCT02215616|"~     The primary objective of this study is to assess the efficacy of laquinimod 0.5, 1.0, and~     1.5 mg qd in patients with HD after 12 months of treatment using the UHDRS-TMS.~   "
64323|NCT02215382|"~     The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine~     combination on hemodynamic parameters and intraocular pressure during tracheal extubation.~      This prospective, randomised study was designed to compare two reversal methods with respect~     to changes in IOP, heart rate and blood pressure during tracheal extubation period.~   "
64324|NCT02215369|"~     The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose~     veins. AngioDynamics, Inc., the company that manufacturers the VenaCure device, is~     sponsoring this study to assess the safety and effectiveness of the VenaCure EndoVenous~     Laser Treatment (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins~     (IPVs). The VenaCure EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics~     for the ablation of IPVs.~   "
64325|NCT02215356|"~     This randomised, multi-center, controlled trial is designed to assess the efficacy and~     safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent~     radiotherapy in non-small cell lung cancer~   "
64306|NCT02215603|"~     Great controversy exists with respect to the optimal or the minimum volume, intensity, and~     frequency of physical activity capable of attenuating the hazards of prolonged sitting on~     the metabolic profile. Thus, our study aims to comprehensively investigate the effects of~     disrupting prolonged sitting with different physical activity protocols on metabolic risk~     factors in sedentary males.~      Ten sedentary males will take part in this randomized cross-over trial consisting of four~     27-h conditions. All conditions will be identical except for the physical activity:~     prolonged sitting intervention (SIT) participants will sit continuously for 9 hours;~     prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min~     every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged~     sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min~     moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they~     will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout~     +interval standing intervention (MVPA-STAND), participants will perform a 30-min~     moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they~     will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of~     sitting. Blood glucose, insulin, lipids and cytokines will be determined.~      The investigators expect that disrupting prolonged sitting with intermittent standing and a~     moderate-exercise bout will positively affect the metabolic profile of the participants.~     Furthermore, we will investigate if combined, these strategies will have an additive effect.~   "
64307|NCT02215590|"~     The purpose of this study is to:~        1. Test the walking functionality of people following Acquired brain injury (ABI)~        2. Suggesting a new treatment for their walking impairments~        3. Follow-up of motor learning ability and balance after intervention within this~          population~      The investigators intend to target dynamic stability and gait after ABI, in a group of~     individuals with ABI who have persistent balance and mobility deficits despite being able to~     walk independently and having high scores on standard clinical balance measures.~      Interventions: Training with Re-Step system shoes.~      In this study there is no control group.~   "
64308|NCT02215577|"~     Study Title Comparison of two different models of liver growth stimulation in advanced~     colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection~      Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial~      Study duration The planned duration of study participation for an individual subject from~     inclusion to follow-up are 3 years~      Primary investigator:~      Per Sandstrom (Linköping)~      Number of subjects 100 patients randomized in a 1:1 randomization~      Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring~     liver resection, but are not resectable in one step because of a future liver~     remnant/standardized total liver volume of < 30 % extrahepatic metastatic disease is not an~     exclusion criteria if they can be addressed surgically in the future~      Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients,~     primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with~     an acceptable level of complications and perioperative mortality.~      To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal~     embolization or portal ligation leading to a shorter treatment period.~      In addition the investigators aim to study if ALPPS may reach these goals without detectable~     or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a~     higher proportion of patients reaching R0.~      Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate~     resected compared to the previously established methods with portal ligation or~     embolization.~      This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien~     grade 4 complication or higher (H0).~      The ALPPS approach will increase the growth rate compared to portal embolization/ligation~     measured one week after the primary intervention.~   "
64309|NCT02215564|"~     The objective in this observational cohort study of young adults sampled at three intervals~     during the academic year is to ascertain if there is carriage of B. pertussis in~     asymptomatic individuals. We hypothesize that in asymptomatic college students there is no~     carriage of B. pertussis detectable by polymerase chain reaction (PCR) assay.~   "
64310|NCT02215551|"~     Decompressive laminectomy (DL) is the most common type of back surgery performed in older~     adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal~     causes pain and trouble walking. An estimated one in three people who undergo DL do not get~     well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside~     of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do~     poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of~     treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61~     The aim of this study is to identify conditions other than LSS that place Veterans at risk~     of poor DL outcomes so that future comparative effectiveness studies can be designed that~     examine the impact of a more comprehensive approach to treatment. Investigators believe that~     a patient-centered rather than a disease-centered approach will lead to superior outcomes,~     less suffering, and more appropriate use of health care resources.~   "
64311|NCT02215538|"~     This study will look at the effectiveness of osmotic release oral system (OROS)~     methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in~     adults. Concerta has received FDA approval for childhood ADHD and there is documentation~     that it is effective in adult ADHD. However this trial will explore its effectiveness in~     treating symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III)~     criteria. Subjects will experience one screening visit and one baseline visit. Those who~     meet admission criteria will enter the double-blind phase. This will involve two 4-week~     treatment periods one of which will involve the use of Concerta and the other a placebo~     pill. Subjects who complete the double-blind phase will be allowed to enter a 180-day,~     open-label Concerta phase designed to assess long-term effects.~   "
64312|NCT02215525|"~     A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of~     extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement~     (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic~     subjects with chronic hepatitis C.~   "
64313|NCT02215512|"~     In this dose-escalation study, the safety and tolerability of escalating dose levels of~     RRx-001 administered intravenously twice a week in subjects with brain metastases receiving~     whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is~     identified, further (up to approximately 30) participants will be recruited. The study will~     use MRI to monitor changes in tumor blood flow associated with RRx-001.~   "
64314|NCT02215499|"~     This study is being conducted to evaluate the safety, tolerability, blood distribution and~     effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.~   "
64338|NCT02215187|"~     The primary purpose of this research is to evaluate the impact of a telehealth-based,~     cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult~     informal military family/friend caregivers of OIF/OEF service members with a~     deployment-related TBI.~   "
64315|NCT02215486|"~     The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ~     systems such as the respiratory, circulatory, and urinary systems. It consists of two major~     components, the parasympathetic nervous system (PNS) and the sympathetic nervous system~     (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the~     state of chemical and metabolic balance within an organism; it is disturbed in situations of~     uncontrolled stress.~      Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full~     body massage, with limited assessment of ANS function, and lacked control groups.~      The effects of head massage therapy (HMT) on regulating the activity of the ANS have not~     been studied before. In this pilot study, we propose that by randomizing 10 participants to~     sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of~     measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as~     Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT~     in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a~     better and balanced profile of autonomic nervous system after receiving massage.~   "
64316|NCT02215473|"~     Bacteremia represents the presence of live germs in the blood stream. Patients with gum~     disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily~     activities such as mastication can induce bacteremia in these patients. Dental procedures~     related to bleeding also induce bacteremia. However, there are many questions that should be~     clarified. Among them, clinical strategies that are able to reduce the levels of germs in~     blood should be determined. This desirable effect could be particularly important for some~     patients, for example, for those at higher risk for endocarditis. Therefore, this study~     tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental~     instrumentation could reduce the levels of bacteria in the blood. In addition, the~     occurrence and magnitude of bacteremia in patients with gum disease were investigated by two~     different laboratorial techniques. After receiving verbal and written explanations and after~     signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum~     disease having dental plaque and tartar were randomly allocated in one the following groups:~     a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth~     rinse. In a preliminary visit volunteers underwent a complete periodontal examination which~     included clinical measurements (inflammatory and debris accumulation indicators), microbial~     (tongue and dental plaque samples collected with paper points), saliva (to determine volume~     and biological indicators) and gingival crevicular fluid sampling (to monitor gingival~     inflammation profile). In the next visit, dental instrumentation was performed under local~     anesthesia, after the mouth rinse single use in the most diseased periodontal~     teeth/quadrant. Blood samples were collected before any dental procedure, 2 and 6 minutes~     after dental instrumentation. Oral hygiene instructions and periodontal treatment were~     performed in additional visits according to individual needs. Finally, the relation between~     bacteremia and several indicators of periodontal status was investigated.~   "
64317|NCT02215460|"~     Periodontitis is a form of gum disease that affects many people in the world. Its~     traditional protocol of treatment includes oral hygiene instruction and dental scaling to~     remove debris, dental plaque and tartar in 4 weekly sections. There is an additional~     time-reduced option also usually cheaper. In this last one, all above described procedures~     are performed within 24 hours. However, up to now comparative effectiveness between these~     both types of treatment is not well understood. For, example it is not clear if patients~     treated in the shorter-time experienced more pain. Therefore, the present study used several~     parameters to clarify whether beneficial differences between these therapeutic protocols~     exist or not. In addition, aspects that could help clinicians' and patient's decisions such~     as experience of pain and anxiety related to dental treatment were also investigated. After~     receiving verbal and written explanations and signed the informed consent form 150~     individuals (n=15/group) having the most common type of periodontitis in adults were~     randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene~     instructions and dental debridement were performed alone or in conjunction with~     antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin~     antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment~     were: indicators of inflammation, amount of oral debris and malodor; quantification of~     bacteria in plaque samples collected with paper points from teeth and tongue; amount of~     produced saliva and self-reported questionnaires to collect information about oral~     condition, daily activities, pain and anxiety related to dental treatment.~   "
64318|NCT02215447|"~     Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a~     highly prevalent disease, responsive to a number of therapies, some of which are proven in~     modern randomised controlled trials, but many of which still require high quality clinical~     trial evidence to confirm their effectiveness and guide their use in practice. This study is~     the first prospective trial to evaluate modern combination chemotherapy. The study will~     determine whether Carboplatin and Paclitaxel NAB is a suitable combination for comparison in~     a subsequent randomised controlled phase III international trial.~      Given the paucity of randomized studies in NETs, there are no clear evidence based~     guidelines. Patients are treated according to guidelines established for small cell lung~     cancer, incorporating platinum (cisplatin or carboplatin) based doublet treatment with~     etoposide. Although these tumors are initially highly chemosensitive, the natural history of~     this disease is such that relapses occur early, which ultimately leads to a very poor~     prognosis. Almost all clinical trials investigating cytotoxic chemotherapy in NETs are small~     single arm studies and guidelines are derived from expert opinion and from extrapolating~     results from small cell lung cancer studies. Prospective clinical trials in this group of~     patients needs to be conducted to establish an evidence based standard of care and to~     improve the prognosis of this highly aggressive group of tumors.~      Participants will receive albumin bound paclitaxel (ABRAXANE®) 100 mg/m2 administered as an~     intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21 day cycle. Carboplatin~     will be given at an Area Under the Curve (AUC) = 5 mg/min/mL on Day 1 only of each 21 day~     cycle administered over 30 mins, beginning immediately after the completion of albumin bound~     paclitaxel administration. Participants can continue treatment at the investigator's~     discretion until disease progression, development of an unacceptable toxicity, or withdrawal~     of consent.~   "
64319|NCT02215434|"~     Female sexual dysfunction (FSD) is an established side effect of Selective serotonin~     reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing~     symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.~      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder~     (HSDD) in women has been demonstrated in studies including naturally and surgically~     menopausal women, either alone or in combination with estrogen, with or without progestin~     therapy.~   "
64320|NCT02215421|"~     A 20 episode video game called Mommio simulates parent-child feeding interactions for~     parents of 3-5 year old children within a storyline addressing a problem commonly reported~     by parents (getting their 3-5 yo to taste a vegetable, which is often a first step toward~     eating the vegetable), thereby training parents in effective food parenting practices. This~     research evaluates whether the 20 episodes targeting barriers identified by parents across~     five levels of difficulty influences vegetable parenting practices and children's dietary~     intake. We had to discontinue the study since changes in commercial availability of game~     development software required reprogramming and available funding did not allow for~     completion of game programming. Thus, no game evaluation was possible.~   "
64326|NCT02215343|"~     The main objective of this study is to investigate in detail how a high-(prebiotic)fibre~     diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged~     population, and if the diet-induced modulation of the gut microbiota mediates changes in~     metabolic risk markers.~      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in~     the gut microbiota composition and to affect markers for insulin sensitivity, lipid~     metabolism and inflammation. The investigators hypothesize that the effect of both~     interventions on the metabolic risk markers will be partly mediated by the diet-induced~     changes in the gut microbiota composition.~   "
64327|NCT02215330|"~     Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical~     retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal~     vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a~     'recurrent central retinitis' and is nowadays commonly known as 'central serous~     chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.~      Although the disease has been known for decades, the underlying mechanism is not yet fully~     understood. Numerous studies have shown an involvement of the retinal pigment epithelium~     (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent~     detachment of the neurosensory retina.~      Among several assumed risk factors, high serum glucocorticoid levels seem to be related to~     the occurrence of CSC.~      CSC typically affects young, male patients unilaterally and causes decreased and distorted~     vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced~     contrast sensitivity. CSC can occur in an acute or chronic form. However, there is no~     agreement in the literature concerning the duration of the two forms. Some authors define~     CSC as chronic if there is persistent subretinal fluid for at least 6 months 11, others~     speak of chronic CSC when symptoms last longer than 3 months. In contrast there are studies~     where CSC is defined acute within the first 4 months. Spontaneously absorption is possible~     in up to 50% and normally leads to the recurrence of a normal visual acuity. Chronic CSC can~     result in a wide spread RPE damage and in a constantly reduction of visual acuity.~      Structural changes in the retina and RPE have been found about 2 months after onset of the~     disease. Those changes can cause accumulation of photoreceptor outer segments, lead to~     consecutive atrophy of the photoreceptor cells and are associated with a loss of visual~     acuity.~      Different concepts of treatment exist, but none of these may be deemed to be the golden~     standard. In the past few years several studies where CSC was treated with photodynamic~     therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic~     reconstitution. However, PDT is a destructive method which causes structural damage and can~     trigger other severe complications like choroidal ischemia and iatrogenic CNV. Furthermore,~     CSC is a self-limiting disease in many cases and physicians often hesitate to perform a~     relatively destructive therapeutical approach to treat a potentially self-limiting disease.~      A newer, non-destructive therpeutical concept is the oral use of eplerenone a~     mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension~     and congestive heart failure. In the recent literature it was shown that eplerenone improved~     CSC and no serious adverse effects were observed in any case. However, no randomised~     controlled studies were performed comparing eplerenone with placebo to evaluate the clinical~     effect.~   "
64328|NCT02215317|"~     Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is~     crucial in risk assessments and therapeutic recommendations for affected individuals. The~     Sleep and Stent Study is a multi-center observational study investigating the relationships~     between OSA and cardiovascular outcomes in patients treated with percutaneous coronary~     intervention (PCI).~   "
64329|NCT02215304|"~     Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy~     infants. Participants are divided at random and unknown to the researchers, in four groups,~     three of which receive one of three probiotic bacteria while the fourth group receives~     placebo product.~   "
64330|NCT02215291|"~     This is a prospective, multi-site registry with longitudinal follow up for patients~     undergoing EGD or endoscopy. The primary objective is to provide a collection of patient~     NvisionVLE™ procedural data for participating physicians, including, but not limited to,~     imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.~      Up to 1000 patients from up to 20 sites nationwide.~      There are no protocol defined follow up visits. Patients will undergo an initial baseline~     Volumetric Laser Endomicroscopy (VLE) procedure. A patient with a negative screening~     examination may not require additional screening endoscopies. For patients with established~     disease, further surveillance endoscopies will vary based on the extent of the disease (e.g.~     every 3 months, every 6 months, annual), which is based on the following American Society~     for Gastrointestinal Endoscopy (ASGE) guideline: the role of endoscopy in the surveillance~     of premalignant conditions of the upper GI tract. If patients have additional VLE procedures~     during the enrollment period, associated data will be collected.~   "
64331|NCT02215278|"~     Recent iron absorption studies with biofortified beans indicated that the currently~     developed beans do not provide an extra amount of iron compared to normal iron beans. This~     effect was ascribed to the inhibitory nature of phytic acid (PA), which is present in high~     concentrations. A possible solution to alleviate problems associated with the high PA~     concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit~     a good agronomic performance, were tested in a human absorption study in Switzerland and~     provided a higher amount of bioavailable iron compared to their parent beans with normal PA~     concentrations. However, the informative value of the study for the real life situation is~     limited due to the simple study design with a relatively large amount of isotopic label~     added extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron~     sufficient women in a non-bean consuming population. Additional investigations are necessary~     to verify that iron bioavailability from lpa beans is high and that their performance is~     better compared to common biofortified beans in a real life situation. A multiple meal~     randomized crossover study in Rwandese women with low iron status will be done to measure~     iron absorption from three different beans (lpa bean line, biofortified high iron bean,~     normal iron bean as a control). During the study, the subjects will receive multiple meals~     to reduce the amount of extrinsic label, therefore more closely simulating hypothetical~     dietary iron intake from lpa beans. This will also allow to avoid an overestimation of the~     effect of inhibitors and to minimize the influence of intra subject day to day variation.~     The study will be divided into two parts. In part one, two of the three bean varieties will~     be fed as part of composite meals over several days (morning and lunch) and in part two, the~     remaining bean will be administered as part of composite meals over several days (morning~     and lunch). Iron absorption from the three varieties will be measured and compared with~     erythrocyte incorporation of stable isotopic labels 14 days after test meal administration.~   "
64332|NCT02215265|"~     The main objectives of the PATHOS study are:~      To assess whether swallowing function can be improved following transoral resection of~     HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to~     personalise treatment, based on disease biology (HPV status and pathology findings), to~     optimise patient outcomes.~      To demonstrate feasibility of recruitment- if the phase II recruits successfully, PATHOS~     will continue to a Phase III study aiming to show non-inferiority of survival in the reduced~     intensity treatment arms.~   "
64333|NCT02215252|"~     The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a~     monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral~     neuropathy (DPN)~   "
64334|NCT02215239|"~     The purpose of this study is to investigate the effectiveness of intervention applying WHO~     Healthy Workplace Framework and Model to enhance the level of physical activity on~     employees. This research is an experimental intervention study recruiting two working types~     in four workplaces. Two working types are: (1) Working type A: Workers tend to be seated~     during work hours. Two telecommunications enterprises will respectively stand for the~     experiment group and the control group. (2) Working type B: Workers tend to be standing~     during work hours. Likewise, two different enterprises will respectively stand for the~     experiment group and the control group. Purposive sampling method will be used to select the~     experiment group. The intervention plan is to implement a cyclic or iterative process~     recommended by WHO.~   "
64335|NCT02215226|"~     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers~     and their infants who develop disease versus those who do not. Use this comparison to~     establish antibody levels associated with reductions in risk of GBS disease in infants aged~     less than 90 days.~   "
64336|NCT02215213|"~     The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the~     study participants will receive Vitamin D in supplement form. Pregnant women will be~     individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till~     the time of delivery.A blood sample will also be collected from the participant at the time~     of recruitment /before the starting of the supplementation for the assessment of Calcium,~     Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D~     level to assess vitamin D status will be done after completion of the supplementation phase~     at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan~     University laboratory~   "
64337|NCT02215200|"~     This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at~     least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte~     colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at~     least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1~     Diabetes (T1D).~      The primary objective of the study will be to determine the safety and ability of low dose~     ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D~     patients demonstrating residual beta cell function.~   "
64339|NCT02215174|"~     Statins are the first-line and most commonly prescribed drugs for the prevention of~     cardiovascular diseases and stroke in the world. Our preliminary studies suggest that~     Caucasians might have a higher risk of developing potentially life-threatening drug-drug~     interactions than Asians when taking statins. Drug-drug interactions occur in the body when~     two or more drugs interact in a way that alters their effectiveness and/or toxicity. These~     interactions are becoming an increasingly severe problem with statin usage since patients at~     higher risk for cardiovascular diseases also take statins combined with many other drugs,~     such as antihypertensive and diabetic drugs. Our study is aimed at understanding the~     molecular factors and providing a sound basis for the interethnic dosage and response~     differences for statins.~      Drug-transporting proteins in intestine and liver tissues are responsible for taking up~     statins into the blood. It is hypothesized that there are interethnic function differences~     of these proteins and that they account for differences in statin blood levels between~     Caucasians and Asians and the frequency and/or severity of their respective drug-drug~     interactions. A clinical study will be conducted with Caucasian and Asian subjects~     undergoing gastric bypass surgery so excess intestine and liver tissue can be acquired as~     part of the standard procedure. Protein levels will be quantified in the tissues and~     correlate them with different statin blood levels.~   "
64340|NCT02215161|"~     Abiraterone acetate is now considered the standard of care for patients with metastatic~     castrate-resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Patients with~     primary or acquired abiraterone resistance typically have rapidly progressive, refractory~     disease for which limited treatment options are available. The development of new therapies~     in mCRPC requires a focus on patients with primary or acquired resistance to abiraterone.~     Patients with abiraterone-refractory mCRPC have a poor prognosis overall with median~     survival after progression of disease at approximately 19 months. While chemotherapy is a~     standard approach in this setting, it is refused by many patients and clinicians due to~     toxicity concerns.~      Selinexor is a first in class Selective Inhibitor of Nuclear Export (SINE) that specifically~     blocks the karyopherin protein Exportin 1 (XPO1/Exportin 1). XPO1 is a key regulatory~     protein responsible for the nuclear export leading to functional inactivation of tumor~     suppressor proteins (TSPs) and is up-regulated 2-4 fold in all cancers studied to date.~     Selinexor, given orally, has demonstrated potent anti-cancer activity in animal models of~     prostate cancer including inhibition of PC3 driven bone metastasis.The goal of this trial is~     to evaluate the potential for a progression free survival benefit associated with Selinexor~     administration in patients with abiraterone-refractory mCRPC.~      Single agent phase II open label study of Selinexor in patients with mCRPC with prior~     therapy with standard hormone ablation agents and abiraterone. A maximum of 54 evaluable~     patients will be accrued for this study, provided the early stopping criteria are not met.~      The starting dose for all patients will be an oral dose of 65 mg/m2, given twice per week at~     least 48 hours apart. Tablets for Selinexor oral administration will be supplied in two (2)~     strengths: 10 and 25 mg of active ingredient per tablet. Dexamethasone will be~     coadministered at a dose of 2 mg twice daily on the day of dosing and the day after.~      Patients will be followed for 30 days after completion of treatment or removal from study,~     or until death, whichever occurs first. Patients removed from study for unacceptable~     treatment related adverse event(s) will be followed until resolution or stabilization of all~     treatment related adverse events to Grade 2 or lower.~   "
64341|NCT02215148|"~     To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury~     patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute~     brain injured patients~   "
64342|NCT02215135|"~     Corifollitropin alfa, single dose administered sustains multiple follicular development for~     7 days. However, It may induce ovarian hyperstimulation syndrome (OHSS), especially in high~     responder women such as patients of polycystic ovary syndrome (PCOS). In GnRH antagonist~     protocol with agonist triggering of final oocyte maturation, following embryo~     cryopreservation can almost eliminate the risk of OHSS. To decrease the injection burden and~     prevent OHSS in PCOS patients undergoing IVF treatment, ovarian hyperstimulation with~     Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering of final oocyte~     maturation, following elective embryo cryopreservation was designed in this study. The~     purpose of this trial was conducted to confirmed whether this novel protocol could prevent~     OHSS, decreased the injection burden of PCOS patients and single dose corifollitropin alfa~     could support multiple follicular growth for 7 days.~   "
64343|NCT02215122|"~     This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate~     (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations~     (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749~     inhalers.~   "
64344|NCT02215109|"~     The authors investigated the consecutive change of retinal vessel's diameter in affected eye~     and fellow eye of Branch Retinal Vein Occlusion.~   "
64345|NCT02215096|"~     This Phase I, open-label, dose-finding, multicenter study is designed to determine the~     recommended Phase II dose (RP2D) for the combination of an orally administered~     Phosphatidylinositol-4,5-bisphosphate 3-kinase beta (PI3K-beta) inhibitor (GSK2636771) with~     enzalutamide. Subjects with phosphatase and tensin homolog (PTEN)-deficient metastatic~     castration-resistant prostate cancer (mCRPC) who are receiving a stable dose of enzalutamide~     with a recently demonstrated progression (either by RECIST [Response Evaluation Criteria In~     Solid Tumors] version 1.1, prostate-specific antigen [PSA] progression, and/or progression~     in bone) per the Prostate Cancer Working Group 2 (PCWG2) criteria will be enrolled. Eligible~     subjects will be enrolled in the Dose-Escalation Phase to determine the maximum tolerated~     dose (MTD) of the combination therapy using a modified 3+3 dose escalation procedure. The~     safety, pharmacokinetics (PK) and clinical efficacy will also be assessed to guide the~     selection of the RP2D. The starting dose will be GSK2636771 300 mg once daily in combination~     with the recommended dose (160 milligram [mg] once daily) of oral enzalutamide. Once the~     RP2D has been established, additional subjects will be enrolled in the Dose Expansion Phase~     to further evaluate the safety, PK and preliminary clinical activity. Safety assessments~     will be performed throughout the study including physical examinations, vital signs,~     clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events.~     Blood samples will be collected for pharmacokinetic analysis. Subjects will continue~     treatment until an unacceptable toxicity, disease progression, withdrawal of consent or~     death occurs. A post-treatment follow-up visit will be performed within 30 days of the last~     dose of study treatment. Xtandi is a registered trademark of Astellas Pharma Inc~   "
64346|NCT02215083|"~     The purpose of the study is to determine whether daily, high-dose administration of~     l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients~     with breast cancer.~   "
64347|NCT02215070|"~     The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in~     reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic~     stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing~     acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.~   "
64389|NCT02214524|"~     This is a randomized, open label, parallel two arm, clinical study, which compare the Bair~     Hugger forced-air warming blanket and the conventional warming care practice in China on~     patients undergoing major surgery to determine the impact of maintaining normothermia on~     intraoperative blood loss, requirement for transfusion of packed red blood cells and the~     changes of coagulation function.~   "
72152|NCT02112955|"~     The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing~     stroke self-management program on recovery of community-dwelling stroke survivors.~   "
64348|NCT02215057|"~     General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as~     most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections~     were performed deep into the orbit, but it is now accepted that peribulbar injections using~     shorter needles are safer. In the last few years, continuing concern over the rare but~     serious complications of sharp needle blocks has led to increasing interest in the use of~     sub-Tenon`s blocks utilizing a blunt cannula 1-5.~      Even with the use of blunt canulae sub-Tenon`s block, serious problems can still occur,~     especially in myopic patients with large axial length. In phakic IOL surgery,topical~     anesthesia has been used successfully for years. Topical anesthesia has several advantages~     over regional infiltrative techniques, the foremost of which is the abolition of any risk of~     inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient~     satisfaction, but still there are some patients that experience intraoperative discomfort.~      In this study we compared topical anesthesia alone with topical anesthesia plus intracameral~     lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision~     implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common~     adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory~     blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL~     placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be~     because of the direct action of lidocaine on the iris, which in turn causes muscle~     relaxation.~   "
64349|NCT02215044|"~     Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was~     given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15~     every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and~     characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor~     marker response in response to the combination of BI 2536 with gemcitabine in patients with~     locally advanced or metastatic pancreatic adenocarcinoma.~   "
64350|NCT02215031|"~     Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for~     intravenous (i.v.) infusion~   "
64351|NCT02215018|"~     To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI~     44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation~     and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further~     doses.~   "
64352|NCT02215005|"~     The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and~     80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril.~     Therefore the relative bioavailability of telmisartan and ramipril given in combination was~     determined in comparison with either telmisartan or ramipril given alone.~   "
64353|NCT02214992|"~     Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose~     combination versus its monocomponents given concurrently~   "
64354|NCT02214979|"~     Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril~     fixed-dose combination (FDC) versus its monocomponents given concomitantly~   "
64355|NCT02214966|"~     The objective was to investigate the relative bioavailability of the fixed dose combination~     (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the~     bioavailability of the FDC tablet while fasting.~   "
64356|NCT02214953|"~     To compare the oral bioavailability and rate of absorption of four prototype~     extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR)~     tablets in healthy male volunteers.~   "
64357|NCT02214940|"~     First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect~     of BI 11634 on coagulation parameters after multiple-dose administration (no primary~     endpoint in a statistical sense defined)~   "
64358|NCT02214927|"~     -  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking~          solution (no primary endpoint in a statistical sense)~        -  Safety and tolerability of the IR-tablet formulation and solution~        -  PK profile of the single ascending doses of the IR-tablet formulation (including~          analysis of dose proportionality)~   "
64359|NCT02214914|"~     First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of~     BI 11634 on coagulation parameters~   "
64360|NCT02214901|"~     Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS~   "
64361|NCT02214888|"~     Study to determine the efficacy (including American College of Rheumatology (ACR) 20~     response rate), safety, and pharmacokinetics of BIRB 796 BS as monotherapy in patients with~     moderate to severe rheumatoid arthritis who have failed at least one disease modifying~     antirheumatic drug (DMARD)~   "
64362|NCT02214875|"~     This study aims to address the research question: Will continuous quality improvement, using~     a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of~     HIV-infected pregnant women and mothers at six and 12 months postpartum?~      Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to~     systematically improve services and health outcomes. The Break Through Series (BTS) is a~     specific CQI approach is a short-term (6- to 15-month) learning system that brings together~     teams from several hospitals or clinics (collaboratives) to seek improvement in a focused~     topic area through a common process of data sharing and review Primary Objective To assess~     whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at~     health facilities implementing CQI-BTS approaches than at health facilities not implementing~     CQI-BTS approaches.~      Secondary Objectives~      To assess whether implementation of CQI-BTS initiatives at health facilities increases:~        1. Uptake of PMTCT services by HIV-infected pregnant women;~        2. Retention-in-care of HIV-infected women at twelve (12) months postpartum;~        3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;~        4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected~          women in health facilities.~   "
64416|NCT02214160|"~     This open-label long-term safety and efficacy study will provide an opportunity for LC-FAOD~     patients to be treated with UX007 for up to 3 years or until market approval under a single~     standardized protocol. The subjects may have participated in other studies or treatment~     programs with UX007/triheptanoin but would be consolidated into one program for long-term~     maintenance and consistent safety monitoring. The study is designed to obtain long-term~     safety information and evaluate maintenance of efficacy in a diverse LC-FAOD population.~   "
64363|NCT02214862|"~     The PET tracer [F18]-FDDNP has a specific affinity for lesions containing tau protein.~      The study consists of two phases:~        -  In the first (cross-sectional) phase it will be assessed the uptake of [18F]-FDDNP in~          10 cases with progressive supranuclear palsy (PSP, a tauopathy) en 10 with multi-system~          atrophy (MSA, a non-tauopathy), along with 20 individuals with Unclassifiable~          Parkinsonism, as previously defined in a European cohort study.~        -  In the second (longitudinal) phase it will be prospectively followed the 20~          unclassifiable patients (at 6, 12 and 18 months) by means of validated scales and~          accepted diagnostic criteria in order to try to correlate their eventual clinical~          diagnosis with baseline PET findings. On this basis, we endeavour to estimate the~          ability of this technique to detect in vivo underlying tau pathology in subjects~          initially unclassifiable on clinical grounds.~      We hypothesized that:~        1. Patients with clinically definite PSP will present an increased uptake in basal~          ganglia, brainstem and cerebellum.~        2. Patients with clinically defined MSA will not present specific uptake.~        3. Part of unclassifiable patients with parkinsonism will present a pattern of uptake~          similar to patients with clinically defined PSP and this part along the clinical~          follow-up will be meet clinical criteria for diagnose of PSP~   "
64364|NCT02214849|"~     The purpose of this study is to find out if a two-way texting platform to be used as an~     adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among~     women enrolled in the WIC program in Connecticut. The hypothesis of the study is that~     providing additional information and support through text messaging starting in pregnancy~     and continuing after the birth of the child will increase exclusive breastfeeding rates~     during the first six months of life.~   "
64365|NCT02214836|"~     The purpose of this study is to determine whether new software processing of ultrasound~     images can improve detection and size determination of kidney stones.~   "
64366|NCT02214823|"~     Project Summary: Patients who have a length of stay four or more days in ICU and requiring~     mechanical ventilation assistance to breathe for more than 48 hours will be invited to~     participate. Participants will be randomised to either receive Functional Electrical~     Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously~     been shown to improve physical function, patients who receive cycling as a treatment will~     have one leg that cycles and the other leg that cycles with assistance of electrical~     stimulation as we want to establish the effectiveness of the addition of electrical~     stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be~     measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive~     function will also be measured at hospital discharge, 6- and 12-month follow-up. A small~     group of patients in this study will be invited to provide samples of blood, urine and~     muscle at ICU admission and discharge to try and determine what happens to muscle in~     patients who are critically ill.~      Significance of the Project: This is an important study because the development of~     ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function.~     Early treatment to maintain strong muscles during an intensive care stay may help speed up~     recovery and enhance participation in other rehabilitation treatments and improve functional~     activities and cognition. These are important objectives for both patients and their~     families. In addition understanding why the muscles become so weak so quickly in patients in~     ICU will help to develop treatments that may help to maintain muscle strength.~      Study Hypotheses:~      Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at~     hospital discharge.~      Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at~     6 month follow up.~      Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic~     signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care~     rehabilitation.~   "
64367|NCT02214810|"~     Postsurgical pain may effectively be treated with a multimodal approach that incorporates~     the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be~     effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown~     to reduce opioid use, improve functional outcomes, allow for early mobilization, and~     decrease hospital length of stay. However, local anesthetics, via wound infiltration, are~     often short-acting and do not meet the duration of postsurgical pain due to their solubility~     and protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of~     bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. This~     formulation has been shown to have little to no adverse effects; although some studies have~     reported adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting,~     and dizziness. The occurrences of these adverse events were still less than the placebo~     cohort.~   "
64368|NCT02214797|"~     The aim of this study is to assess visual performance of prototype soft contact lens designs~     compared to commercially available contact lenses over one-week of lens wear.~   "
64369|NCT02214784|"~     Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which~     happens when physical activities such as running, jumping and lifting etc are carried out or~     when increased pressure to the bladder in everyday life is applied by simply sneezing or~     coughing.~      There are various treatment options available - surgical operations, pelvic floor~     exercises/muscle training and electrical stimulation. This study aims to prove that using~     the Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen~     and tone them and in doing so improving stress urinary incontinence. We are comparing the~     Neurotech Vital device with an altered Neurotech Vital device that does not give the same~     stimulation treatment. There is a 50% chance of you receiving the altered device, if you do,~     you will be offered the non-altered Neurotech vital device after your first 12 week~     treatment programme. Both devices are identical in looks, but give different stimulations~     through the skin contact electrodes.~   "
64370|NCT02214771|"~     The study aims to describe the characteristics and the methods of management and follow-up~     of patients treated with fidaxomicin for Clostridium difficile infection (CDI).~   "
64371|NCT02214758|"~     The aim of the study is to evaluate the impact of six month long nutritional and oral health~     intervention on nutritional status, oral health, functional performance and hospital~     admission/costs on older persons using home care services. Additionally, participants are~     interviewed at home regarding their drugs use and this information will be compared with~     medication information in electronic patient records.~   "
64372|NCT02214745|"~     To evaluate the demographic characteristics of patients suffering from mental retardation or~     cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and~     will be distributed amongst this population in order to identify these characteristics.~   "
64373|NCT02214732|"~     Anxiety, stress and depression are common during pregnancy and in the postpartum period. The~     lack of empirically supported, non-pharmaceutical interventions for psychological distress~     in pregnancy is a significant gap in the literature, especially given many pregnant women's~     preference for non-pharmaceutical treatments. This study will evaluate the efficacy of~     Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological~     distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women~     endorsing high levels of distress.~   "
64374|NCT02214719|"~     A closed loop system for diabetes care utilizing an insulin pump, continuous glucose sensing~     and appropriate mathematical modelling to guide insulin dosing is a goal for those with Type~     1 diabetes. Yet the cost of the associated hardware will be prohibitive for many people with~     diabetes or their health care payers. Carbohydrate counting, insulin dose correction~     systems, basal bolus regimens with or without an insulin pump all facilitate glucose control~     but frequent adjustment to a diabetes regimen is a necessary cornerstone to successful~     diabetes management; if all that is used is the regimen suggested by the health care~     provider at a visit and this regimen is left unchanged until the next visit or contact then~     success will be limited. A readily available user friendly program suitable for a smart~     phone or tablet would have widespread applicability and benefit. The investigators~     hypothesize that such an app linked into a web site that facilitated review of glucose~     records will be acceptable to people with diabetes and improve glucose control. Our long~     term goal is to create an app that can advise on diabetes management.~   "
64375|NCT02214706|"~     The purpose of this study is to improve the therapeutic outcome of laser therapy for port~     wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser~     and topical sirolimus.~   "
64376|NCT02214693|"~     This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and~     tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.~   "
64377|NCT02214680|"~     In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)~     eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic~     effect on the pupil, however the combined effect of alpha agonist and beta blocker has not~     been studied.~   "
64378|NCT02214667|"~     Treatment adaptation and implementation study for adult jail inmates with co-occurring~     substance use disorders.~   "
64379|NCT02214654|"~     The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger~     anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.~   "
64380|NCT02214641|"~     This three-year award will pilot-test an innovative intervention, Resilient, Empowered,~     Active Living with Diabetes (REAL), targeting underserved minority young adults with~     poorly-controlled diabetes. The individually tailored, community-based intervention merges~     findings of an in-depth needs assessment, principles of an evidence-based occupational~     therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management~     strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,~     acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to~     produce positive changes in diabetes self-care and glycemic control. The study will~     randomize 80 young adults with diabetes to receive either the six-month REAL intervention or~     an attention control condition. Blinded data collectors will assess glycemic control,~     diabetes self-care behaviors and quality of life outcomes, as well as potential intervention~     mediators, before and after the six-month intervention. It is anticipated that findings from~     this pilot study will be used to inform a large-scale randomized controlled trial of the~     REAL intervention.~      The study's specific aims and hypotheses are as follows:~      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and~     diabetes self-care.~      Hypothesis: At 6 months (immediately following the intervention), intervention group~     participants will demonstrate improvements in A1C and diabetes self-care as compared to~     control group participants.~      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and~     potential mediating mechanisms (to inform power estimates for a large-scale RCT).~      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in~     secondary outcomes: diabetes-related stress and quality of life, depression, and life~     satisfaction as compared to control group participants.~      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in~     potential mediators of the intervention: habit strength, problem solving, activity~     participation, self-efficacy and diabetes knowledge as compared to baseline.~      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine~     intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures~     (e.g. recruitment, retention, testing protocol).~   "
64381|NCT02214628|"~     The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered~     in combination with anti-VEGF therapy~   "
64382|NCT02214615|"~     This research study is designed to investigate brain response using fMRI scan, and~     behavioral responses, to treatment with the drug carbamazepine (CBZ) in patients with the~     painful sodium channelopathy inherited Erythromelalgia (IEM). This study is designed to~     identify the central nervous system (CNS) regions that are activated during ongoing or~     evoked pain attacks, and the altered CNS response to CBZ treatment. This will advance our~     understanding of how IEM affects the brain. We also hope to validate a pharmacogenic~     approach to the study of IEM by use of an FDA approved drug. We hope, but cannot be sure,~     that subjects will directly benefit from this study.~   "
64383|NCT02214602|"~     The aim of the study is to test the value of immediate post-operative intravesical~     instillation of epirubicin in patients with intermediate and high risk non muscle invasive~     bladder cancer (NMIBC).~   "
64384|NCT02214589|"~     A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU)~     require up to several hundred procedures during their hospitalization. Many of these are~     tissue-damaging procedures (TDPs) known to cause pain [1]. Through funding from NINR, the~     investigators found that TDPs not only caused pain but also increased markers of ATP~     degradation and oxidative stress[2[. The TDP was tape removal, a commonly performed~     procedure in the NICU2.~      Based on this finding, the investigators sought to determine if interventions that relieve~     pain also reduce biochemical markers of ATP degradation and oxidative stress. The~     investigators first examined the effect of oral sucrose, a commonly used intervention, when~     given before a heel lance. The investigators chose heel lance because it is the most~     predominant painful procedure in the NICU, as shown in 29 different clinical trials[3]. The~     investigators hypothesized that since oral sucrose is documented to significantly reduce~     pain scores, then administration of this analgesic will also decrease markers of ATP~     degradation and oxidative stress. However,the investigators observed the opposite effect.~     Although a single dose of oral sucrose reduced behavioral markers of pain, it significantly~     increased biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative~     stress (allantoin) over time[4]. More importantly, the effect of oral sucrose on breakdown~     markers of ATP were enhanced and were significantly higher in neonates that were intubated~     or were receiving more than 30% FiO25. These findings lead to the question: If oral sucrose~     does not effectively reduce the biochemical effects of procedural pain, what intervention or~     groups of intervention will decrease both behavioral markers of procedural pain and reduce~     ATP utilization and oxidative stress in premature neonates? For this RO1 renewal, the~     investigators propose to test the individual and additive effects of two commonly used~     interventions for procedural pain. These interventions are (a) administration of 30% oral~     glucose and non-nutritive sucking (NNS) (b) facilitated tucking and NNS c) administration of~     30% oral glucose, facilitated tucking and NNS. Administration of 30% oral glucose was~     documented to decreased procedural pain scores[6-9] without the potential adverse effects of~     fructose, a key ingredient of sucrose[10-11]. Facilitated tucking is the gentle positioning~     of preterm infants with arms and legs in a flexed, midline position close to the body, while~     either in a side-lying or prone position[12]. Because tachycardia often accompanies pain, a~     documented benefit of facilitated tucking is stabilization of heart rate and reduction of~     motor activity (flailing)[12-13]. Non-nutritive sucking refers to the provision of a~     weight-appropriate pacifier[14]. The painful procedure will be a clinically required heel~     lance, which refers to the puncture of a newborn's heel for blood glucose using a specially~     designed lancet. Our general hypothesis is that commonly used clinical interventions known~     to reduce procedural pain alter biochemical markers of ATP degradation, oxidative stress and~     cell injury.~      Specific Aim 1 will determine whether (a) 30% oral glucose and NNS or (b) facilitated~     tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease~     procedural pain.~      • Pain will be quantified using a validated pain scoring tool, the Premature Infant Pain~     Profile (PIPP). Individual and additive effect of interventions will be determined.~      Specific Aim 2 will determine whether (a) 30% oral glucose and NNS or (b) facilitated~     tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease~     biochemical markers of ATP degradation, oxidative stress and oxidative cell injury.~        -  Products of ATP breakdown in plasma—hypoxanthine (Hx), xanthine (Xa), and uric acid~          (UA)—will be measured using high performance liquid chromatography.~        -  Oxidative stress will be quantified by measuring plasma levels of allantoin using mass~          spectrometry.~        -  Cell injury will be quantified by measuring plasma levels of F2 isoprostane using~          liquid-chromatography/mass spectrometry.~   "
64385|NCT02214576|"~     Tracheal intubation in the ICU is associated with significant complications and morbidity.~     Desaturation is among the most frequent and hazardous complication, occurring in almost one~     out of four intubations, that may in some instances lead to cardiac arrest; despite~     appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but~     does not allow for apneic oxygenation and may not be performed in patients with neurological~     impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with~     acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is~     currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our~     first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to~     determine its use as a means to ensure preoxygenation in those ARDS patients that require~     intubation.~   "
64386|NCT02214563|"~     The purpose of this study is to determine whether cholecalciferol supplementation decrease~     the blood concentrations of hepcidin-25 in hemodialysis patients.~   "
64387|NCT02214550|"~     The purpose of this study is to determine if some women with dysmenorrhea (painful periods)~     are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives~     (OC) can be used to reverse this chronic pain risk.~      Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ~     sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected~     to reduce COS and decrease the risk of developing CPP.~   "
64388|NCT02214537|"~     The embryokinetics may be a new prognostic factor for choosing the human embryos with the~     highest implantation potential. In order to identify the factors that may affect the rate of~     embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen~     tension, oocyte quality or type of medication used for ovarian stimulation. However there~     are no published data with respect to the influence of sperm DNA fragmentation in the embryo~     kinetic.~   "
64417|NCT02214147|"~     The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment~     on the single-dose pharmacokinetics of alisertib in adult participants with cancer.~   "
64390|NCT02214511|"~     Major depression disorder (MDD) is a frequent and disabling mental disorder with great risk~     of recurrence and chronicity. Interpersonal factors are among the strongest predictors of~     the course and duration of an episode of depression. More specifically, social rejection is~     one of the most environmental risk factors of MDD. Targeted rejection predicts hastened~     onset of major depression. On the other hand, healthy subject show prosocial behavior after~     social rejection to reconnect to new source of social interaction. In addition to the~     potential impact of social exclusion on MDD onset, depressed patients may be more prone to~     be rejected as they encounter interpersonal difficulties and may less be able to reconnect~     to the social group after rejection.~      Recent neuroimaging data show that brain processing of social exclusion activate brain~     regions that are central to the pathophysiology of MDD. Some of these regions are also known~     to be activated during physical pain and may contribute to the aversive dimension of the~     experienced rejection. Pro-inflammatory cytokines are involved in MDD physiopathology and~     can induce social withdrawal behavior. Inflammation can modulate social interactions in~     mammals. Moreover, after a social stress such as social rejection, blood cytokines increase.~     At a cognitive level, self-esteem can modulate the sensitivity to social rejection.~      The major objective of the trial is to study sensitivity to social signals in MDD patient~     compared to healthy subject.~      The investigators hypothesize in MDD patient : (1) decrease of rapid facial reactions (RFR)~     to dynamic emotional faces expressing joy, (2) increase of RFR to dynamic emotional faces~     expressing sadness, (3) decrease of prosocial reaction after experimental social rejection.~      Secondary objective is to identify psychological and biological mediators We hypothetize in~     MDD patient: (1)mediating effect of systemic inflammatory cytokines, an (2) mediating effect~     of state self esteem 30 MDD patients and 60 healthy subject will be included. They will~     encounter psychiatric and psychometric evaluation. Their facial EMG will be recorded to~     assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces~     database, coupled to occulometric recording. Subjects will perform cyberball game as an~     experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of~     their prosocial behavior. Questionnaires will assess explicit measurement of social~     rejection pain and desire of affiliation. Inflammatory markers will be measured in a blood~     sample before the cyberball task for every subjects and 6 hours later for 20 healthy~     volunteers. Dosage of IL-6, IL-10, TNFa, IP-10, MCP-1, MIP-1b, Rantes, sIL-6Ra, IL1ra, VEGF,~     Leptin, PECAM1, sTie2, sVEGFR1, sVEGFR2 will be performed by luminex technique and usCRP,~     srIL2 ans sCD14 by ELISA technique.~   "
64391|NCT02214498|"~     Rationale:~      The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular~     disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In~     general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred~     to as dippers versus non-dippers. Evening administration of treatment might lower~     nocturnal blood pressure more effectively than morning administration, which is most~     commonly advised.~      The main hypothesis of this study is that evening administration of antihypertensive~     medication might resume the dipping pattern in non-dippers and as a consequence might reduce~     CVD risk more than morning administration.~      Primary objective (in short):~      -to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can~     resume a dipping blood pressure pattern in non-dippers~      Study design: A double-blind placebo-controlled cross-over study Each person will use for~     one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the~     evening, and one period of six weeks the other way around~   "
64392|NCT02214485|"~     Objective: To determine the differential effectiveness of integrated care (IC) and lower~     extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.~      Method: The investigators randomize participants at Bei-Hu site from the Intervention study~     of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial~     into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks~     and 6 months after initiation of the interventions.~      Interventions:~        1. IC: Participants visit the study site with health education, social activities, warm~          up, stretch, and low intensity resistance exercise for about 1 hour per week. If any~          medical problems or functional decline suspected during the visit, the case manager~          refers participants to their primary care physicians for further managements.~        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining~          using isotonic strength training machines each week. The intensity is set at 60-80% of~          1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2~          weeks for individualized adjustments~   "
64393|NCT02214472|"~     Rumination syndrome is characterized by effortless recurrent regurgitation of recently~     ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a~     previous study the investigators showed that rumination is produced by an unperceived,~     somatic response to food ingestion.~      After having identified the key mechanisms of rumination, the investigators developed an~     original EMG guided biofeedback technique with specific targets for correction, based on~     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the~     investigators showed the potential effectivity of this treatment. The current aim is to~     validate this previous uncontrolled observation by a formal placebo-controlled, randomized~     trial.~   "
64394|NCT02214459|"~     The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk~     interventions. The DASH program of diet and exercise based lifestyle change is the most~     well-established, evidence-based behavioral intervention to control HTN. Its recommendations~     are central to HTN control national guidelines and consumer health products aimed at~     behavioral management of HTN. However, translating these recommendations into~     population-wide, inexpensive, sustainable programs have to date proven largely unrealized.~     The objective of the proposed study is to determine the efficacy of a HTN intervention~     behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about~     the DASH diet, physical activity and HTN related behaviors from health coaches trained in~     evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a~     smartphone app that captures patients' behavioral data using intuitive self-tracking for~     DASH diet intake and Bluetooth wireless sensors for blood pressure, weight and physical~     activity and 2) a web-based coaching portal through which health coaches view and respond to~     patients' behavioral data and assist them in setting goals for changing behaviors consistent~     with their HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to~     determine improvement from baseline to 3-month follow-up in physiological (blood pressure,~     weight); behavioral (diet & physical activity); and psychological (e.g., quality of life)~     measures over a 3-month intervention. Completing this research will result in preliminary~     feasibility and efficacy data for a larger randomized efficacy trial.~   "
64395|NCT02214446|"~     The purpose in this study was to investigate the current status, changes, correlation, and~     predictive factors of the truth telling, hope, care burden, and quality of life during~     treatment in primary caregivers of newly diagnosed children with cancer.~   "
64418|NCT02214134|"~     SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the~     molecular characteristics of their disease. The thoracic tumors include lung cancer,~     malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular~     characteristics are identified, there might be the possibility to offer these patients~     access to targeted clinical trials.~   "
64396|NCT02214433|"~     Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called~     Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in~     NCT02214355). The registrations have been revised so all parts of this single trial (Parts~     A-C) are now included in this single registration (NCT02214433).~      The primary purpose of each part is provided below:~        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio~          1450 (tablet formulation) under varying gastric conditions~        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of~          multiple ascending doses of Debio 1450, administered sequentially IV and orally, once~          or twice daily.~        -  An additional 10 volunteers participate in PART C which is designed to assess the~          absolute bioavailability of various formulations of Debio 1450 under varying gastric~          conditions~      The dose administered during Part A is based on the safety, tolerability and PK data from~     study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single~     oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C~     based on the available safety and PK data from preceding cohorts.~   "
64397|NCT02214420|"~     Prior trials have shown that many G1 CHC patients are ineligible or intolerant to PEG-based~     regimens due to prior severe side effects, worsening of cytopenias, exacerbation of~     underlying psychiatric disorders, or autoimmune disorders. These patients will not be~     candidates for treatment with the approvals of SMV and SOF in early 2014 due to the~     combination with PEG-regimens. Results of the COSMOS study suggest that these patients are~     likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,~     and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed~     in order to confirm this hypothesis.~   "
64398|NCT02214407|"~     This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with~     individual therapeutic benefit aim:~      Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced~     proliferative Chronic Myelomonocytic Leukemia (CMML)~      The primary objective of the study is to compare between the two arms Event-free Survival~     (EFS).~      Secondary objectives are to compare between both arms:~      Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3~     and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity~     (hematological and non hematological) Prognostic factors~   "
64399|NCT02214394|"~     This study involves the use of an experimental device which will measure how much propofol~     is present in your exhaled breath during surgery compared to how much is in your blood. The~     study results will look at whether the device is as accurate as conventional methods for~     measuring propofol levels during surgery.~   "
64400|NCT02214381|"~     Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or~     Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly~     non frail primary breast cancer patients with increased risk of relapse.~   "
64401|NCT02214368|"~     The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV)~     bundle strategy compared with a conventional treatment in postoperative patients with ARF.~   "
64402|NCT02214342|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and~     gait) in people with mild cognitive impairment.~      The investigators hypothesize that the virtual reality-based balance training intervention~     will improve balance and gait performances in people with mild cognitive impairment compared~     to a control group receiving usual care only.~   "
64403|NCT02214329|"~     Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients,~     thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy~     of a virtual reality game based exercise training for improving postural body sway and gait~     in diabetes patients with peripheral neuropathy. The exercise training has been specifically~     designed for DPN patients with lost lower extremity joint perception and uses~     state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide~     real-time joint feedback through an interactive interface on a LCD monitor. The~     investigators hypothesize that tailored exercise with real-time visual joint feedback during~     exercise will reduce improve balance and gait.~   "
64404|NCT02214316|"~     Children with concussion may improve with intravenous fluids.~   "
64405|NCT02214303|"~     The prevalence of allergic diseases, especially airway allergic diseases, has increased~     dramatically over the last twenty years all over the world including Lithuania. Allergic~     diseases are associated with significantly reduced quality of life and can sometimes cause~     death. Allergic diseases have turned into an important economic and social burden and~     nowadays take a more and more important place in the health system. Despite all intensive~     investigations, the pathogenesis of allergic airway diseases still remains unclear. As~     allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important~     to investigate not individual cells, but examine various inflammatory cells instead,~     including their biological products and possible cellular interactions along the course of~     allergic diseases. This research focuses on the cells that are claimed to be important in~     the pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell~     subset (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell,~     eosinophil. This study aims at determining the importance the way the Th9 lymphocytes~     perform, the eosinophil's activity, as well as molecular factors affecting these cells has~     in the process of prognostication of allergic airway diseases, namely allergic rhinitis and~     allergic asthma. An allergen challenge test will be performed in order to define the meaning~     of pathogenetic changes. The results of this research may reveal useful information in the~     course of allergic diseases and may be valuable when creating strategic principles of~     prophylaxis. The findings could be used for prevention and early diagnostics of allergic~     diseases and it could also open doors to discovering new and effective treatment.~   "
64419|NCT02214121|"~     The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and~     pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of~     twice-daily treatment in paediatric patients with sickle cell disease~   "
64420|NCT02214108|"~     The purpose of this study is to determine the effect of interactive video game in management~     of overweight in children. The investigators will evaluate the effect of product versus~     standard physical activity.~   "
64406|NCT02214290|"~     Caffeine is an exceedingly popular and consumed pharmacological agent. Although caffeine is~     primarily consumed from coffee and tea beverages, it is also available in other forms such~     as sodas, energy drinks, tablets and capsules. Nevertheless, caffeine acutely increases~     brachial and aortic systolic blood pressure (BP) and arterial stiffness. Arterial stiffness~     is an independent predictor of cardiovascular disease (CVD) and assessed through pulse wave~     velocity (PWV). Interestingly, previous studies have proposed that caffeine may increase~     aortic BP through increases in aortic PWV and augmentation index (AIx), a measurement of~     wave reflection. Yet, these effects were seen in middle-aged adults with treated~     hypertension and a wide age range. Therefore, it is imperative to consider that caffeine may~     cause different effects in young normotensive individuals than in older adults independently~     of BP levels. Importantly, oral supplementation of the amino-acid, L-citrulline has been~     shown to enhance the bioavailability of L-arginine levels and nitric oxide (NO) production~     and, therefore, improve arterial function. L-citrulline supplementation for 7 days given at~     6 g/day has shown to increase NO levels while improving PWV. Previous studies by our group~     also demonstrated that L-citrulline supplementation reduces the BP response to cold~     exposure; a condition with an increased vasoconstriction. Therefore, the acute effects of~     caffeine on central and peripheral PWV and BP in healthy young men are yet to be fully~     evaluated. We hypothesized that acute caffeine intake would increase peripheral and aortic~     BP and PWV and that L-citrulline supplementation would attenuate the effects induced by~     acute caffeine ingestion.~   "
64407|NCT02214277|"~     The Sentinel System will be a safe and effective method for capturing and removing embolic~     material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce~     the ischemic burden in the cerebral anterior circulation.~   "
64408|NCT02214264|"~     The purpose of this study is to evaluate and compare the effectiveness of several brief~     trainings based on contemplative practices and positive psychology to buffer against the~     negative effects that acute stress has on behavior and cognitive abilities. The~     investigators hypothesize that training will buffer against negative effects of acute~     stress.~   "
64409|NCT02214251|"~     We aim to investigate the higher level mechanism of gait disorders in PD patients by~     ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG)~     signals during unconstrained walking. Independent component analysis will be conducted for~     signal analysis. The connectivity among different brain regions will also be investigated.~     The PD patients received deep brain stimulation will be recruited for the study. The local~     field potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly~     with EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles~     of these deep structures in ambulation and their functional connectivity with other brain~     regions during walking.~   "
64410|NCT02214238|"~     This study will test the hypothesis that the modified positive airway pressure (PAP) device~     for OSA will be no worse than a market released product in terms of its treatment efficacy,~     comfort and patient compliance. Patients will have their treatment pressure titrated using~     polysomnography (PSG) in the sleep laboratory, and then in a random order will spend~     additional time undergoing PSG using both devices, and using both devices at home for 3~     weeks. Data will be collected from the PSG studies, device downloads, independent~     pressure-flow loggers, and custom questionnaires.~   "
64411|NCT02214225|"~     This is a study to assess the immune (antibody) response and safety of a bioCSL split~     virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed~     2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine~     containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years~     and above.~   "
64412|NCT02214212|"~     This study proposes to investigate how well Bright White Light Therapy will work in the~     acute inpatient rehabilitation units for people whom have experienced a traumatic brain~     injury for the purpose of treating sleep disruption. Participants will be assessed based on~     sleep efficiency, thinking abilities, therapy participation, and perception of~     fatigue/sleepiness. In previous studies dim red light has not had the same effects on~     function as bright white light, and will be chosen for use as a placebo. Each subject will~     be randomized to receive 30 minutes of either Bright White Light Therapy or Red Light~     Treatment each morning for 10 days.~      To measure the effect of this treatment, the investigators will measure the each~     participants sleep daily by using an actigraph watch. This watch will record movement~     continuously. The investigators will also measure the subjects' report of how well they~     slept, whether fatigue is present, and how attentive they are before and after treatment.~      Research Hypothesis:~      In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning~     Bright White Light with a comparison group exposed to Red Light in an acute inpatient~     rehabilitation setting.~   "
64413|NCT02214199|"~     The objective of this protocol is to compare degree of improvement can be achieved in~     patients with shoulder pain by treatment with Manipulative Techniques for the~     cervicothoracic spine versus home exercises.~   "
64414|NCT02214186|"~     Introduction: Pre-eclampsia is a multifactorial syndrome which occurs in hypertension and~     proteinuria in pregnant women over 20 weeks gestation. It is the leading cause of maternal~     complications such as pulmonary edema, which occurs in about 3% of severe preeclamptic~     having as one of the causes volume overload. Anesthetic procedures are frequent in this~     population, with replacement with crystalloid of the duct during cesarean section under~     spinal anesthesia for combat hypotension and hypovolemia manifested by oliguria. However, as~     water therapy have antagonistic effects on cardiopulmonary and renal systems is no doubt as~     to the benefits compared to conventional or restrictive pattern of fluid therapy on renal~     function. Objective: To compare the renal function of patients with severe preeclampsia who~     received restrictive fluid therapy during caesarean section, as well as evaluating the use~     of cystatin C and Neutrophil gelatinase-associated lipocalin (NGAL) as a predictor of renal~     damage in this population. Hypothesis: Intraoperative fluid restriction did not influence~     renal function of patients with severe preeclampsia undergoing cesarean section under spinal~     anesthesia.~   "
64415|NCT02214173|"~     The purpose of this study is to investigate the effects of the nutritional supplement rice~     bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with~     HIV. The hypothesis is that there will be a significant improvement in metabolic syndrome~     and immune variables in HIV-positive participants in the intervention group compared to the~     control group.~   "
64421|NCT02214095|"~     This study is the first evidence based work evaluated the systemic use of glucosamine as an~     adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of~     glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of~     patients with moderate to advanced chronic periodontitis~   "
64422|NCT02214082|"~     Study intends to determine if there is any difference in the occurrence of major adverse~     cardiology events in patients discharged on the same day as their elective cardiac~     angioplasty or discharged one day after their angioplasty.~      Hypothesize that same day discharge is as safe as a day later discharge.~   "
64423|NCT02214069|"~     The purpose of this study is to examine whether patients can use the AliveCor case to record~     their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus~     rhythm~   "
64424|NCT02214056|"~     The main objective of this study is to assess the feasibility of standardized screening for~     comorbidities among patients with one or more of three chronic diseases (diabetes, COPD,~     atherosclerosis) by a mobile unit at times and localities under-served by health actors.~   "
64425|NCT02214043|"~     There are no special clinical characteristics of acute pulmonary embolism in Chinese~     population.~   "
64426|NCT02214030|"~     This study was performed to evaluate the safety and efficacy of a locally designed Assiut~     Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression~     devices have been developed thorough the past decades without being strongly implemented in~     the catheterization laboratory. Their limited adoption reflects concerns of high cost and~     conflicting data regarding their safety~   "
64427|NCT02214017|"~     Progress in technology has made telemedicine-based solutions with video consultations~     available in the management and treatment of chronic diseases like diabetes, heart failure~     and lung insufficiency at home. However, no direct comparisons on health outcomes of~     telemedicine using video consultations versus usual outpatient treatment are available.~      We wanted to implement a model of telemedicine and to evaluate health indicators in type 2~     diabetes patients treated by video consultations or the standard outpatient treatment~   "
64428|NCT02214004|"~     The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and~     safe in the preoperative treatment for postmenopausal patients with hormone~     receptor-positive and HER2-positive breast cancer.~   "
64429|NCT02213991|"~     The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy~     for the replacement of boost-external beam radiotherapy in Korean women who are candidates~     for breast-conserving treatment.~   "
64430|NCT02213978|"~     The purpose of this study is to analyze the effect of the prophylaxis of venous~     thromboembolism in the critical ill patients, and at the same time, to find out the risk of~     venous thromboembolism and hemorrhage events occurred under the prophylaxis.~   "
64431|NCT02213965|"~     A peripheral intravenous catheter is the most commonly used vascular access device in~     medicine. Primary objective is to compare insertion and handling of two peripheral~     intravenous catheters in clinical routine.~   "
64432|NCT02213952|"~     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in~     all the assistance levels, and they have big repercussion referring to individual, social~     and labour levels, supposing a big consumption of human and material resources.The cure with~     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a~     decrease in the cicatrization time comparing to conventional methods in hospital levels,~     which becomes interesting contrasting its efficacy in primary care.~      AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers,~     comparing to the conventional treatment ( cure with humid environment), in primary care~     patients with chronic venous insufficiency in C-6 degree (CEAP classification).~      DESIGN: A study will be executed, which will consist in a randomized clinical test,~     multicentered, in parallel groups and opened. 150 patients suffering of venous vascular~     ulcers will be studied, who will be between the age of 40-100 years old, and who will be~     attached to 10 health centers. Variables for the identification, following, result and~     patient profile have been defined. Emphasize the variables of ulcer area decreasing,~     CIVIQ index, % one cure per week.~   "
64433|NCT02213939|"~     Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma~     and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can~     cause a systemic inflammatory response syndrome (SIRS) which is associated with increased~     morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a~     potential benefit for cardiac surgery patients.~      The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with~     the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore,~     the investigators conduct this prospective, observational pilot study to determine the~     clinical impact of the use of a cytokine adsorbing circuit during CBP.~   "
64434|NCT02213926|"~     The purpose of this study is to characterize the safety and efficacy profile of ACP-196~     (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).~   "
64435|NCT02213913|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with combination chemotherapy and to see how well they work in treating patients~     with v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)-associated B-cell~     lymphomas. Lenalidomide may stop the growth of B-cell lymphomas by blocking the growth of~     new blood vessels necessary for cancer growth and by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as lenalidomide, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop cancer~     cells from growing. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine~     sulfate, doxorubicin hydrochloride, cyclophosphamide, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer~     growth in different ways by targeting certain cells. Giving lenalidomide together with~     combination chemotherapy may be an effective treatment in patients with B-cell lymphoma.~   "
64752|NCT02209753|"~     The clinical objective of this study was to determine the effect of BIRB 796 BS on~     pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population~     pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of~     treatment in patients with moderate to severe plaque-type psoriasis.~   "
64436|NCT02213900|"~     The purpose of this study is to investigate the effectiveness of a preventative low-dose of~     Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or~     thoracotomy.~      Delirium is state of severe confusion and some symptoms include:~        -  Cannot think clearly~        -  Have trouble paying attention~        -  Have a hard time understanding what is going on around them~        -  May see or hear things that are not there. These things seem very real to them.~   "
64437|NCT02213887|"~     The purpose of this 9-day study is to determine if:~        1. Pantoprazole modifies the steady-state plasma concentrations of orally administered~          psychotropic medications including valproic acid, lithium, and second-generation~          antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,~          paliperidone, quetiapine, risperidone, ziprasidone)~        2. Serum gastrin levels change within a week of starting or stopping pantoprazole~   "
64438|NCT02213874|"~     The purpose of this research is to understand the relationship between trust in the health~     care system and choice of contraception during the postpartum period among pregnant women~     receiving prenatal care.~      Research subjects will complete a questionnaire at enrollment and between delivery and~     within 5 days of hospital discharge.~      A chart review will also be completed to gather use of a birth control method at the six~     week postpartum visit as well as pertinent medical diagnoses and recorded data such as~     height, weight, body mass index, and contraceptive plan as documented in the postpartum~     medical chart.~   "
64439|NCT02213861|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE~     administered topically to skin lesions in patients with early-stage cutaneous T-cell~     lymphoma (CTCL).~   "
64440|NCT02213848|"~     The purpose of this study is to evaluate the effect of calcium chloride against residual~     neuromuscular blockade at the end of general anesthesia~   "
64441|NCT02213835|"~     The aim of this study is to determine the tolerability and potential efficacy of dietary~     therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease~     (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to~     determine tolerability, preliminary safety and potential efficacy in pediatric patients with~     CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the~     investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of~     10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the~     study for approximately 12 weeks.~   "
64442|NCT02213822|"~     The purpose of this study is to discover genetic changes associated with different cancers.~     With the information from this study the investigators hope to provide better ways to~     prevent, detect and treat many cancers.~      Many diseases can result from changes in a person's genetic material that causes cells to~     not work properly. Currently, researchers and doctors know some of the genetic changes that~     can cause disease, but they do not know all of the genetic changes that can cause disease.~      This project is designed to identify genetic changes that can cause cancer in humans.~     Specimens will be collected from a scheduled diagnostic or routine (i.e. blood draw for~     counts) procedure and may include samples from the tissue itself (surgery), bone marrow,~     blood, saliva, urine, spinal fluid, sputum, joint fluid, seminal fluid, ascites (a fluid~     that fills up in the abdomen), and/or pleural fluid (fluid in the lung cavity), to either~     confirm the diagnosis of cancer or to help to decide how best to treat cancer or other~     illness. Additionally archived tissue may be analyzed. Samples may be stored for future use~     in later experiments. The Department of Pathology at Rhode Island Hospital will store the~     samples.~      Information from the medical record, such as responses to treatments or family history of~     cancer, will be collected.~   "
64443|NCT02213809|"~     Background:~      COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most~     patients with COPD are discovered and treated in primary health care. Co-morbidity with~     heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is~     important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which~     is the most important factor for decelerating the progress of COPD. In addition, medication~     and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have~     shown poor quality of primary health care provided to patients with COPD.~      As general practitioners often deal with multiple medical problems and patients' motivation~     when diagnosing and treating COPD we hypothesize that case method education (see description~     under intervention) in COPD has better effect than traditional education (see description~     under intervention).This study aims to examine the effect of case method education on (1)~     learning in COPD among general practitioners and on (2) health in their patients with COPD.~      Method:~      Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be~     randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs)~     in COPD for their general practitioners. The educations will be held during two times (two~     hours each) within a time range of three months, covering examination and treatment of~     patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random~     sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients~     will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome~     measures) as well as questions about medication, exacerbations and other chronic diseases.~     The questionnaire will be sent to the patients 1-2 months before the education and 18 months~     after the education. Differences in assessments in the questionnaire before and after the~     education will be compared between the patients listed at the PHCCs that have received case~     method education vs. traditional education. In addition, general practitioners~     (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12~     months after the education, covering the learning outcomes in order to study differences in~     learning between the two intervention groups.~   "
64444|NCT02213796|"~     This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem~     during early phase of severe sepsis and septic shock in critically ill patients in an~     intensive care unit.~      Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE~     II score, SOFA score, BUN, Cr and blood culture will be collected.~      Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried~     out during the first and second dose after 1g meropenem administration. Blood samples~     (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25,~     0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h.~      Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr.,~     2001).~      The pharmacokinetics of meropenem will be modelled from concentration-time profile using~     compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will~     be conducted and the results will be reported as % PTA (Probability Target Attainment) and~     %CFR (Cumulative Faction Response)~   "
64445|NCT02213783|"~     This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g~     every 6 h of imipenem in twelve patients with febrile neutropenia following administration~     by a 4 h infusion or bolus injection.~      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte~     Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA~     (Probability Target Attainment) and %CFR (Cumulative Faction Response.~   "
64446|NCT02213770|"~     High-intensity training (HIT) has repeatedly been documented to have superior positive~     effects compared to moderate exercise in patients with coronary heart disease and heart~     failure. Since heart transplant recipients (HTx), have a denervated heart with different~     respond to exercise, HIT has previously not been introduced among these patients.~     Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found~     that this form of exercise also was highly effective and safe in long term HTx with~     clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL,~     and even slower progression of CAV (coronary allograft vasculopathy). Based on these~     findings we ask the following questions in this follow-up study:~        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study~          period continue during long term follow up (5 years)?~        2. Is the intervention group more physical active after HIT compared to the control group?~   "
64447|NCT02213757|"~     The purpose of this study is to determine if vaginal estrogen use is associated with~     resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The~     hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will~     have higher rates of resolution of hematuria after treatment course with vaginal conjugated~     equine estrogen cream compared to placebo cream~   "
64448|NCT02213744|"~     This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The~     trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the~     chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic~     HER2-positive breast cancer patients. Patients may not have been previously treated with an~     anthracycline in any setting. Patients must have received prior treatment with trastuzumab~     in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the~     metastatic or locally advanced setting, have either progressed or are intolerant to~     pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12~     months of pertuzumab treatment in the neoadjuvant or adjuvant setting.~   "
64449|NCT02213731|"~     The purpose of this clinical study is to assess the single procedure outcomes of using~     cryoballoon ablation without additional empirical lesions and/or complex fractionated~     electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year~     from first diagnosis of persistent AF).~   "
64450|NCT02213718|"~     This study is to assess the effect of desflurane on myocardial function in patents who~     underwent coronary artery bypass grafting.~   "
64451|NCT02213705|"~     The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic~     mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment~     will be given to patients with a rapidly evolutive disease or refractory to~     cyclophosphamide.~   "
64452|NCT02213692|"~     Blood loss during liver resection significantly associates with short term operative~     outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume~     centers. Conventional method (crush-clamp) has been a standard technique for liver~     transection. Technique advances related to liver transection have contributed to reduction~     in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe~     and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated~     with decreased operative time, blood loss and transfusion requirement, and an increased~     incidence of postoperative bile leakage. However, no randomized study has compared the~     difference between liver resection using traditional technology and harmonic Scalpel. The~     objective of this prospective randomized study is to compare the safety and efficacy of~     liver resection using the harmonic scalpel device with the crush-clamp technique in~     respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay~     and postoperative complications.~   "
64453|NCT02213679|"~     Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent~     studies have shown that CFS is associated with impaired cellular energetics and low levels~     of phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor~     of creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps~     prevention of CFS. The overall hypothesis to be evaluated is that medium-term~     supplementation with GAA will improve clinical outcomes in well-defined adult CFS patients~     via augmented provision of creatine. Specific aims: (1) To determine the effects of GAA on~     CFS symptomatology using a fatigue severity inventory, soreness of locomotive apparatus~     scales, and a health-related quality of life survey; (2) To determine the effect of GAA on~     creatine metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To~     characterize the physiological effects of GAA on work capacity via actigraphy and exercise~     performance tests; and (4); To determine the prevalence of subjectively reported~     side-effects and biochemical adverse events associated with GAA intervention.~   "
64454|NCT02213666|"~     The presence of intracardiac thrombi and their propensity for systemic embolism is a major~     concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing~     cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the~     clinical gold standard imaging modality for visualization of the right atrial appendage~     (RAA) and left atrial appendage (LAA) for detection of thrombi as well as risk factors~     associated with thrombus formation, including spontaneous echo contrast and low LAA~     velocity. However, TEE is a moderately invasive procedure that incurs additional risk, cost,~     and patient discomfort. In addition, thrombus detection via TEE may be ambiguous, and~     another tool capable of confirming uncertain TEE findings is desirable. This is particularly~     crucial in cases when adequate LAA imaging cannot be acquired or if TEE is clinically~     contraindicated, requiring alternative imaging modalities that can visualize these~     structures.~      Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is~     routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture~     and periprocedural catheter visualization. A majority of imaging acquired during AF ablation~     is performed with the ICE catheter in the right atrium (RA). However, these standard views~     are often unable to provide sufficient visualization of the LAA structure due to the~     relatively long distance between the ICE catheter and LAA.~      Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization~     of the LAA over other locations by reducing the anatomic distance between the imaging~     catheter and structure of interest. Recent retrospective studies have confirmed improved~     assessment of the LAA with ICE imaging from the PA and equivocal sensitivity and specificity~     when compared with TEE for evaluation of LAA thrombus. However, these studies did not~     systematically evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.~      Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE~     findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is~     required. We hypothesize that this prospective and blinded study will confirm ICE as~     non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of~     thrombi.~   "
64482|NCT02213289|"~     The purpose of this study is to determine if doctors can use the results of special tests of~     subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a~     specific drug that is targeted to work against that abnormality (called molecular profiling)~     and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it~     is given with standard chemotherapy.~   "
64455|NCT02213653|"~     Anemia in patients with cancer is a common problem associated with an impaired quality of~     life.~      Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin~     levels in 40-70% of patients and decreased transfusion requirements.~      Absolute or functional iron deficiency is also common with about 30% of cancer patients with~     all histologies combined iron deficiency and anemia.~      Several studies have shown the benefits of the combination of intravenous iron to~     erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the~     investigators knowledge, has not been specifically performed on a population of patients~     with functional iron deficiency.~      In addition, in clinical practice, this association is not carried out in particular because~     there is no dosage or consensus sequence for the administration of iron associated with~     ESAs.~   "
64456|NCT02213640|"~     Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral~     neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to~     pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses~     induce a shift to the right visual field for improving symptoms in short term.~      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency~     resulting from stroke with encouraging results. The hypothesis of the study is to evaluate~     the usefulness of brain stimulation as an adjunctive intervention to optimize and increase~     the rehabilitation of unilateral neglect to long-term.~      Thus, the main objective is to evaluate the effectiveness of standard treatment with~     prismatic adaptation with anodal tDCS or sham tDCS.~   "
64457|NCT02213627|"~     The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin~     administration) is effective in a controlled ovarian stimulation protocol in oocyte donors~     compared to daily gonadotropin administration (recombinant FSH or HP-hMG)~   "
64458|NCT02213614|"~     The word lithium frequently conjures images of catatonic psychiatric patients and side~     effects so severe that premature death is commonplace. But naturally occurring lithium is a~     far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an~     essential mineral for maintaining physical and mental health. When exposure is low, suicide~     rates, mental illness and violent crime increase~   "
64459|NCT02213601|"~     The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative~     to a wait-list control (WLC) condition, for improving psychological functioning and~     health-related quality of life in depressed postpartum women. It was hypothesized that the~     yoga intervention would be significantly more efficacious than the wait-list control~     condition in reducing symptoms of depression and anxiety, and improving health-related~     quality of life, at the end of the 8-week yoga intervention.~   "
64460|NCT02213588|"~     This study evaluates the response to oxidative stress in healthy men and women after taking~     a blend of plant concentrate.~   "
64461|NCT02213575|"~     This study is a mechanistic study that will enroll 9 subjects who are participating in~     NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that~     minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic~     hypertensive individuals) to test whether the antihypertensive effect of minocycline is~     associated with a decrease in activated microglia in central nervous system autonomic~     regions as evidenced by changes in PET and MRI imaging.~   "
64462|NCT02213562|"~     The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum~     flower oil in suppressing serum uric acid.~   "
64463|NCT02213549|"~     This study is designed to evaluate the effect of ume paste and ginger powder on glucose~     metabolism in prediabetic subjects.~   "
64464|NCT02213536|"~     To investigate the use of a scalp sparing technique of radiotherapy treatment designed to~     treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy~     result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and~     re-growth similar and slow.~      It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will~     reduce hair loss and increase the speed and evenness of re-growth.~   "
64465|NCT02213523|"~     This is a proof of concept study that evaluates the response to oxidative stress in healthy~     men after taking plant concentrates.~   "
64466|NCT02213510|"~     ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called Zip~     Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer~     for surgical incisions or laceration repair. The study will be comparing the Zip Surgical~     Skin Closure to standard sutures in patients undergoing cardiovascular implantable~     electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance~     of resulting scar, and overall cosmetic appearance of scar. The study will be following~     participants for 3 months following CIED procedure.~   "
64467|NCT02213497|"~     Patients with esophageal cancer to be treated with concurrent preoperative proton therapy~     along with carboplatin and paclitaxel.~   "
64468|NCT02213484|"~     The primary objective of this study is to determine whether specific patterns of circulating~     micro-ribonucleic acids (miRNAs) are associated with aortic aneurysm and dissection in~     patients with hereditary aortopathy syndromes. The most common of these syndromes is Marfan~     Syndrome (MFS), but several other recognized aortopathy syndromes are well characterized.~     The investigators propose the use of a simple blood test, from which miRNA profiles can be~     measured in individuals with aortopathy syndromes to be compared with miRNAs observed in a~     control population that has no known predisposition for aortic disease. The investigators~     hypothesize that microRNA profiles in individuals with Marfan syndrome, and related~     disorders, will be distinct from those seen in a control group. The investigators predict~     that up- or down-regulation of certain miRNAs will correlate with the presence and severity~     of aortic aneurysm, responses to medical therapy, and ultimately could be used to determine~     when an individual may be at risk of dissection.~   "
64469|NCT02213471|"~     Effective communication between physician and patient is fundamental to effective care. The~     recent introduction of electronic patient on-line portals has the potential to change the~     communication landscape. The investigators surveyed patients to assess their preferred~     modality for biopsy notification at 3 institutions with differing patient access to on-line~     portals, to ascertain what patient preferences are currently and if it has changed from~     historical preferences. Our hypothesis is that as patients become more familiar with ln-line~     portals, their preferences will likely reflect familiarity with this modality.~   "
64470|NCT02213458|"~     This is a 3 year clinical trial evaluating the benefits of a program that supports model~     care for patients with dementia and their family caregivers. Subjects will be recruited from~     several sites in San Francisco. Subjects determined to be eligible will be consented and~     randomized into one of two groups. Two thirds of patients will be enrolled into Navigated~     Care that provides them with assistance in meeting important benchmarks in their care, for~     example completion of legal and financial planning and strategies for minimizing caregiver~     burden. One third of patients will be enrolled to a control group, entitled Survey of Care.~     Outcomes include quality of life, health care utilization, caregiver burden, and~     satisfaction with care.~   "
64471|NCT02213432|"~     The purpose of this study is to determine the timing of influenza vaccination to induce~     higher antibody response in adult patients with non-hematologic malignancies receiving~     scheduled cytotoxic chemotherapy.~   "
64472|NCT02213419|"~     Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in~     abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant.~     The diagnosing specific type of cystic lesion is limited in spite of recent advances of~     diagnostic modalities. Surgical resection is generally recommended for malignant and~     potentially malignant lesions. However, surgical resection has significant morbidity and~     sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of~     the pancreas reported that complete resolution was achieved in only one-third of patients.~     Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.~      The purpose of this study is the double ethanol lavage is a safe and effective method for~     treatment in those with the indeterminate pancreas cysts.~   "
64473|NCT02213406|"~     This project will examine neuronal and sensory fat perception. Our hypothesis is that~     subjects being either hypersensitive or hyposensitive for fat will show different brain~     activities. Therefore the investigators will conduct functional magnetic resonance imaging~     (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.~   "
64474|NCT02213393|"~     The objective is to study the effectiveness of supplementing a standard hospital and 12-week~     home menu with protein-enriched Cater with Care products in reaching a protein intake of~     1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in~     elderly patients.~   "
64475|NCT02213380|"~     The purpose of this study is evaluate postoperative delirium after general anesthesia and~     regional anesthesia in elderly patients undergoing hip fracture surgery. Our research~     hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of~     postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient~     and reduce healthcare costs associated with postoperative delirium. (3) Postoperative~     delirium may result in poor long-term functional outcomes.~   "
64476|NCT02213367|"~     Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and~     chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of~     the population suffers from the disease. Although all age groups can be affected, the peak~     incidence is seen between 20 and 40 years of age. The duration of the disease is generally~     several years but is likely to be longer in more severe cases, cases with concurrent~     angioedema, in combination with physical urticaria or with a positive autologous serum skin~     test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep~     deprivation and psychiatric comorbidity being frequent. It also has a large impact on~     society in terms of direct and indirect health care costs as well as reduced performance at~     work and in private life.~   "
64477|NCT02213354|"~     This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males~     and females, 65 years of age and older, who are in good health and meet all eligibility~     criteria. This clinical trial is designed to assess the safety, reactogenicity, and~     immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by~     Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5,~     or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and~     Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and~     immunogenicity data will be collected at standard time points with safety follow-up to~     continue through one year post dose 2. Study Duration is approximately 30 months and Subject~     Participation is approximately 18 months. The primary objectives are to (1) assess the~     safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of~     an MF59-adjuv~   "
64478|NCT02213341|"~     The purpose of this study is to assess the responses in the immune system of infants after~     they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The~     investigators will do this by studying the immune cells and allergy responses in the blood~     prior to and after receipt of the third DTaP vaccine.~   "
64479|NCT02213328|"~     Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of~     antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as~     pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose~     of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as~     part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to~     19 years of age.~   "
64480|NCT02213315|"~     A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity~     of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.~   "
64481|NCT02213302|"~     Preoperative anxiety is a subjective and painful experience and may have adverse~     psychological consequences and complicate anesthetic management. The aim of the study is to~     show the effect of premedication by midazolam on preoperative anxiety assessed by a visual~     analog scale and by measuring salivary cortisol levels. This study was a monocentric,~     prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to~     79 years, to undergo elective surgery under general anesthesia with tracheal intubation must~     be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome~     is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are~     the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation~     of respiratory and hemodynamic adverse effects of midazolam.~   "
64791|NCT02209246|"~     The investigators of this study would like to see whether providing feedback to patients~     regarding their illness behavior/coping strategies, using online questionnaires, improves~     patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128~     patients.~   "
64483|NCT02213276|"~     Diabetes is associated with an increased risk of bone fractures, but current predictors of~     bone fracture seem to underestimate this risk. It is commonly known that increased levels of~     certain biochemical bone markers predict low-energy fractures, but the pattern of these~     markers in diabetics still show heterogeneity and inconsistency. Part of the pathology of~     diabetes is a high blood glucose level, and this can potentially influence bone turnover and~     thereby bone markers. Chronic inflammation in patients with inflammatory bowel disease is~     shown to increase bone resorption, and the same may be the case in diabetics. The purpose of~     this project is to investigate whether glucose has a direct effect on bone markers or an~     indirect effect through intestinal hormones or inflammatory processes.~   "
64484|NCT02213263|"~     This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in~     patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to~     be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall~     Response Rate, is similar to that of rituximab-EU.~   "
64485|NCT02213250|"~     The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK~     study and to support the registration in China.~   "
64486|NCT02213237|"~     It has always been a real challenge to treat sepsis in critically ill patients. The~     mortality is as high as 20％ in patients with severe sepsis and 46％ with septic shock~     develops. Early diagnosis and early treatment are the principles. Along with appropriate~     resuscitation, judicious and thoughtful intravenous antibiotic therapy is the critical~     determinant of survival in sepsis and septic shock given that ineffective initial therapy~     worsens the outcome. Blood culture and subsequent susceptibility testing are the gold~     standard for microbiological diagnosis to direct the optimal use of antibiotic. However,~     this conventional approach usually takes 5-7 days to wait for the final report. Positive~     results were reported in only 30% of patients with sepsis and 50 to 60% septic shock.~     Moreover, the very low bacteria level in blood and prior use of antibiotics may prevent~     pathogen growth. Surface-enhanced Raman scattering (SERS) is a novel spectroscopy technique~     based on Raman scattering and localized surface plasma resonance (LSPR), which results in~     strongly enhanced Raman signals derived from molecules attached to nanometre-sized gold (Au)~     and silver (Ag) structures. SERS provides the structural information of biomedical molecules~     with ultra-sensitive characterization down to single molecular level in fast and~     non-destructive manner. The clinical application of SERS in sepsis will first help to~     recognize pathogens as well as their specific drug sensitivity, and then optimally guide the~     initial antibiotics usage. Plasma from twenty blood culture proven Gram positive, negative~     and Candida cases will separately subject to metabolomics profiling and bioinformatics~     analysis to establish each pathogen metabolites profile. The sensitivity and specificity of~     SERS and metabolomics in identifying pathogen and antibiotics-resistant strains will be~     evaluated. The investigators expected both techniques to play a crucial role in modern~     sepsis treatment and bring great impact on mortality reduction.~   "
64487|NCT02213224|"~     The aim of this current study was to assess the therapeutic effects of perindopril and~     telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic~     effects of these two kind of drugs.~      This study is a randomized parallel control clinical trial which would be carried out in~     Nanfang Hospital, Southern Medical University.~      About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan~     and amlodipine three groups.~   "
64488|NCT02213211|"~     Malaria is an important contributor to ill-health experienced by school-children and may~     have profound consequences for their learning and educational achievement, and there is a~     small, but growing, body of evidence that suggests malaria control can help improve~     educational outcomes. In Malawi, school-aged children are estimated to experience 0.59~     clinical attacks of malaria each year, equivalent to 2.1 million attacks among Malawian~     school-aged children. To avert this health burden and potential education consequences, Save~     the Children in partnership with the Malawian Ministry of Health is providing treatment of~     symptomatic malaria cases in schools in southern Malawi, as part of the provision of first~     aid kits (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this~     intervention, a cluster randomised trial is being conducted among 58 schools in Traditional~     Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive~     LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination~     therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.~     The primary outcome is school attendance, with secondary outcomes of grade repetition,~     school drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and~     anaemia. The study aims to conduct several quantitative and qualitative assessments to help~     evaluate the external validity of the findings.~   "
64489|NCT02213198|"~     The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This~     translates to more than $1000 for every man, women, and child in the U.S. Hospitalization~     and Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened.~     There is a push to get people out of hospitals quickly, while they are still quite ill.~     These factors cause patients to be lost in the transition from inpatient to outpatient care.~     Many individuals are repeatedly rehospitalized or continue to clog emergency rooms in an~     attempt to receive care. The importance of transitional care between inpatient/ER facilities~     and outpatient services to prevent this revolving door phenomenon has been continually~     stressed. There is little research on the best way to accomplish smooth transition to~     outpatient care. We developed a 90-day transitional care clinic (TCC) to address this need.~     We propose a randomized treatment outcome study comparing two transitional service packages~     within our TCC: a Standard Care package versus an Engagement-Focused package that features a~     novel intake procedure and a Shared Decision-Making intervention: Access Group is an intake~     procedure designed to address many of the problems of traditional approaches to post-acute~     treatment engagement, including failure of patients to reach intake appointments. Shared~     Decision-Making (SDM) is a structured approach to provider-patient communication that has~     been shown to increase patient involvement in care and improve outcomes. Despite SMI~     patients' desire to be more involved in their treatment decisions and promising early~     evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in~     transitional psychiatric care. In the proposed study, patients referred to TCC will be~     randomized to either Engagement-focused Care or Standard Care. The relative benefit of these~     two approaches will be evaluated in 300 individuals who will be randomized to these two~     treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported~     satisfaction, shared decision making and quality of life will be higher for engagement~     focused care. The new treatment package is designed to get individuals into treatment~     quickly and to teach them how to be good consumers of mental health treatments going~     forward.~   "
64490|NCT02213185|"~     The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile~     water injections.~   "
64491|NCT02213172|"~     The purpose of this study is to determine if two different probiotic strains, Lactobacillus~     paracasei HA-196 and Bifidobacterium longum R0175, are effective in helping subjects manage~     the symptoms of IBS~   "
64492|NCT02213159|"~     The purpose of this study is to determine if Dexmedetomidine given at the end of surgery~     will reduce postoperative morphine consumption and improve postoperative quality of recovery~     as compared to morphine in patients undergoing laparoscopic bariatric surgery.~   "
64792|NCT02209233|"~     The purpose of this study is to determine the effect that receiving massage therapy~     post-operatively has on reducing perceived anxiety and pain in urology patients.~     Secondarily, the result of massage on patient satisfaction, length of hospital stay, and~     narcotic use will also be studied.~   "
64493|NCT02213146|"~     The addition of BioChaperone to already marketed prandial human insulin preparations may~     accelerate the onset and shorten the duration of action due to facilitation of the insulin~     absorption after subcutaneous injection.~      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in~     subjects with type 1 diabetes under a dose of 0.2 U/kg.~      This trial is a single center, randomised, double-blinded, three treatment, three-period~     cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each~     subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg,~     a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3~     separate dosing visits.~   "
64494|NCT02213133|"~     Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC~     of the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort~     3) who have relapsed or have metastasis following chemotherapy.~   "
64495|NCT02213120|"~     The VERTIGO study is likely to help determine characteristics of different types of vertigo~     in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness.~     Moreover, it will also help to develop an understanding about the current management~     practices of this condition at local level.~   "
64496|NCT02213107|"~     Determine the effect of enzalutamide and dutasteride on the time to prostatic-specific~     antigen level increase in patients age 65 or older.~   "
64497|NCT02213094|"~     This is an open labeled dose escalation safety study of vitamin B3-amide dietary~     supplementation in pregnant women with hypertensive complications of pregnancy. The~     investigators will enroll 5 pregnant women at 24-36 weeks' gestation with the diagnosis of~     hypertensive complications of pregnancy. If the woman is anticipated to remain undelivered~     for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day in a single daily~     dose, continuing for two weeks or until delivery, which ever occurs first. Maternal blood~     will be collected at baseline and 2 times per week to measure maternal LFTs and study~     markers (nicotinamide metabolites, sFlt-1-Soluble fms-like tyrosine kinase-1 and PlGF). The~     objective of this dose escalation safety study is to determine the safety of vitamin B3~     amide dietary supplementation during expectant management of hypertensive complications of~     pregnancy.~   "
64498|NCT02213081|"~     The aim of this research is to assess the benefit of a medication (ulipristal) for~     alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.~   "
64499|NCT02213068|"~     This study is being done to investigate the impact of changing immunosuppressive medications~     from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months~     after kidney transplantation. The immune system is the body's defense against infection and~     other disease. After transplantation, the body sees the new organ as foreign and tries to~     destroy or reject it. Immunosuppressive medications help to prevent the immune system from~     attacking the transplanted organ. The primary purpose of this research study is to evaluate~     the effects of three (3) different immunosuppressive treatments on rejection in~     post-transplant kidney recipients. This study will test whether switching from tacrolimus to~     belatacept will improve long-term kidney function.~      Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate~     mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug~     Administration (FDA) to be used after transplant. All of these medications have been~     routinely used in kidney recipients here at Northwestern University.~      Belatacept (the study drug) has been approved by the FDA for use at the time of~     transplant. However, the use of belatacept in this study is considered investigational as it~     has not been FDA approved for use beginning at 3 months after transplant.~      This study will involve 51 adult kidney transplant recipients at Northwestern.~   "
64500|NCT02213055|"~     -  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric~          population.~        -  To evaluate the safety of LiceMD in a pediatric population.~   "
64501|NCT02213042|"~     This is a multicenter, open-label, Phase II study in subjects with Human epidermal growth~     factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines~     of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing~     regimen. This study is a post-approval commitment with regulatory authorities. It is~     designed with the primary endpoint to evaluate the changes in biomarkers associated with HER~     family, immunomodulation, apoptosis, and Adenosine triphosphate binding cassette (ABC)~     transporters between the pre-treatment and disease progression biopsy. It is hypothesized~     that these changes in biomarkers may modulate resistance mechanisms and thereby alters the~     response to subsequent chemotherapy based regimens. Therefore, in addition to the~     description of the clinical outcome of Overall response rate, Clinical benefit rate,~     Progression-free survival and Overall survival for each arm, Progression-free survival on~     next-line therapies will be collected and summarized for each arm. All subjects will receive~     study treatment until disease progression, unacceptable toxicity, or subject withdrawal, and~     after which, will be followed for subsequent anticancer therapy and disease progression~     events, and survival. The primary endpoint of the study will be to evaluate changes in~     expression of biomarkers associated with the HER family or receptors and ligands,~     immunomodulation, apoptosis, and ABC transports between a pre-treatment biopsy and the~     disease progression biopsy. This study will evaluate potential mechanisms to explore the~     antitumor activity of dual blockade and will provide a descriptive clinical outcome for~     subjects treated with Trastuzumab in combination with Lapatinib or chemotherapy. No formal~     comparisons between treatment arms will be undertaken.~   "
64502|NCT02213029|"~     This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and~     pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce~     subendometrial contractractility induced by oxytocin in healthy female subjects.~     Additionally tissues concentrations of epelsiban will be determined from endometrial tissue~     biopsies. Data from this study will inform the identification of the doses of epelsiban to~     be used in future in-vitro fertilization (IVF) clinical studies. Expected number of subjects~     to be randomized are: Cohort 1- 10 subjects, Cohort 2a- 10 subjects for each epelsiban arm~     25 milligrams (mg), 200mg, 5 for placebo, Cohort 2b- 10 subjects per arm with dose to be~     determined, cohort 3- 6 subjects. Cohorts 1 and 2 will be double blind (sponsor unblinded)~     placebo controlled cohorts. Cohort 3 will be an open label cohort, cohort 4 will be a double~     blind (sponsor unblinded) placebo controlled cohort.~   "
64503|NCT02213016|"~     The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in~     patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex~     (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied~     vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment~     (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for~     three months.~   "
64504|NCT02213003|"~     Current islet transplantation into the portal vein of the liver has shown the unique ability~     of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected~     group of subjects with Type 1 diabetes. The main limitations of islet transplantation are~     the need for systemic immunosuppression to maintain function and the loss of islet function~     over time. Additionally, many studies have demonstrated that the current site of~     transplantation in the liver is not an ideal site due to several factors. These factors~     include (1) significant liver inflammation following islet infusion; (2) potential for~     life-threatening procedure-related complications such as bleeding and thrombosis; (3) high~     levels of immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity;~     (4) the inability to retrieve islets after infusion; and (5) development of graft~     dysfunction in a number of recipients of intrahepatic allogeneic and autologous islets. The~     implantation of islets into the omentum will allow adequate engraftment of islets onto the~     omentum and will lead to comparable or superior functional and clinical outcomes than in the~     traditional intrahepatic site.~   "
64505|NCT02212990|"~     This study aims to conduct a double-blind, placebo-controlled study to assess the effect of~     prophylactic antipyretics on the immune responses and rates of fever after inactivated~     influenza vaccine (IIV) in children 6 through 47 months of age.~      In this study, 160 healthy children, 6 through 47 months of age, including some children at~     risk of febrile seizure, will be randomized to one of three different treatment arms.~     Children will receive either blinded therapy with prophylactic acetaminophen or placebo~     immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV~     or open-label ibuprofen every 6 to 8 hours in the 24 hours after receipt of a dose of IIV.~     Children will be followed for the occurrence of fever, fussiness, changes in appetite and~     sleep patterns, and use of medical services on the day of and for two days following~     vaccination. Antibody to influenza antigens contained in the respective 2014-2015 and~     2015-2016 vaccines as measured by hemagglutination inhibition (HAI) antibody will be~     assessed at baseline and four weeks following vaccination. The proportions of children~     experiencing fever, having solicited side effects, using medical services, demonstrating a~     serologic response corresponding to seroprotection and seroconversion to each of the IIV~     antigens will be determined for groups of children in each of the three treatment arms.~     Likewise geometric mean HAI titers (GMTs) and corresponding 95% confidence intervals for~     each IIV antigen will be calculated for the three treatment arms. The investigators hope to~     learn whether or not prophylactic antipyretics affect the immune response and fever rates~     following IIV.~   "
64506|NCT02212977|"~     Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with~     stitches in Port a Cath patients, who, as a population, are at increased risk for~     complications. All adult patients who present for initial Port a Cath placement during the~     recruitment period will be eligible to participate in the study. Subjects will be randomized~     to either skin incision closure with standard stitches or closure with skin glue. Time to~     complete skin closure and costs of closure will be compared. Patients will be evaluated~     approximately one month and three months from the procedure to assess for complications of~     wound breakdown or infection, as well as for the appearance of the Port a Cath incision.~   "
64507|NCT02212964|"~     Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility~     maps and well as susceptibility-weighted imaging post processing the investigators~     hypothesize that the investigators would be able to distinguish between pseudoprogression~     and true progression with the use of an easily implementable sequence on clinical MRI~     scanners.~   "
64508|NCT02212951|"~     The study is to compare meal time glucose control associated with BIOD-531, a rapidly~     absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.~   "
64509|NCT02212938|"~     To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a~     standardised high fat breakfast~   "
64510|NCT02212925|"~     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332~     CL following administration of multiple rising oral doses over 10 days in patients with type~     2 diabetes.~   "
64511|NCT02212912|"~     The purpose of this study is to evaluate whether a multifaceted quality improvement~     intervention can improve the adherent rate of individual and composite of evidence-based~     performance measures for patients with acute ischemic stroke within the first 7 days of~     symptom onset and reduce the incidence of a new clinical vascular event, disability, and~     all-cause mortality at discharge and long term clinical outcome.~   "
64512|NCT02212899|"~     To establish an observational registry for systematic collection of clinical data from~     Renaissance-guided spine surgeries.~   "
64513|NCT02212886|"~     -  This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM~          injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment.~        -  The purpose of the study is to assess safety, tolerability, and efficacy of a monthly~          long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will~          include subjects switching from daily or thrice weekly administration of 20 mg or 40mg~          respectively of glatiramer acetate (GA, i.e., Copaxone) injection~   "
64514|NCT02212873|"~     In order to address and curb the high prevalence of childhood obesity in Malaysia, a~     school-based intervention program, MyBFF@school is developed for implementation in all~     schools in the country. The program is specific for overweight and obese students and it is~     hypothesized that by participating in this program, students will be able to control their~     body mass index.~   "
64556|NCT02212314|"~     The investigators will conduct a pilot study investigating the effectiveness of a~     computerized response inhibition training program at reducing the response inhibition~     difficulties often seen in children with Williams syndrome ages 10-17. The investigators~     hypothesize that after completing the training program, children with Williams syndrome will~     show improvement on computerized measures of response inhibition and on parent measures of~     impulsivity.~   "
64515|NCT02212860|"~     Radiation therapy after surgery to remove breast cancer improves control of the breast~     cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation~     to the entire breast.~      This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered~     only to the area in the breast where the lumpectomy will be performed.~      This study will determine if radiation therapy delivered in this manner will prevent the~     cancer from coming back and eliminate the need for five to six weeks of radiation.~      The study will also gather information about the safety and effects (good and bad) this~     radiation has, and on patient satisfaction with the appearance of the breast.~   "
64516|NCT02212847|"~     Spatial orientation is achieved through central integration of various sensory inputs and~     prior knowledge in a statistically optimal way based on the reliability of the different~     signals. When upright, the subjective visual vertical (SVV) is accurate and precise in~     healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle~     dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have~     been described. In case of a sudden unilateral vestibular deficit (UVD) a significant~     imbalance between the two vestibular organs occurs at the level of the vestibular nuclei,~     disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular~     deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular~     neuritis (VN). While in the acute stage these patients are usually immobilized due to the~     severity of symptoms, recovery is overall good and most patients return to their daily~     activities within a few weeks. Central compensation is considered the most important~     contributor to recovery in these patients, while recovery of the damaged vestibular nerve~     occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral~     vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.~      The percept of vertical can be quantified by assessing the subjective visual vertical or~     SVV, which is usually done by letting subjects adjust a luminous line along perceived~     direction of gravity. Modifications of this paradigm which are independent from retinal~     input are e.g. adjustments of a rod along perceived vertical in complete darkness (termed~     subjective haptic vertical or SHV) and self-alignments along perceived vertical (subjective~     postural vertical or SPV) and perceived horizontal (subjective postural horizontal or SPH)~     in complete darkness. Previous research has proposed no unified percept of vertical as~     errors assessed in different domains (visual, haptic, postural) were diverging in patients~     with acute UVD. While errors were profound for the SVV, the SPV remained accurate.~      Here the investigators aim to quantify verticality perception in patients with either acute~     or chronic UVD and patients with BVD both in upright and roll-tilted positions.~     Specifically, the investigators will use different paradigms to address the ques-tion~     whether there is a unified percept of vertical and how a bias in this percept changes over~     time.~   "
64517|NCT02212834|"~     The purpose of this study is to determine the effectiveness of surveillance breast MRI~     compared to mammography alone in women with a personal history of breast cancer~   "
64518|NCT02212821|"~     The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on~     hunger, and the brain mechanism lying behind it.~   "
64519|NCT02212808|"~     The Infectious Diseases Society of America (IDSA) guidelines recommend two core strategies~     for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2)~     prospective audit with intervention and feedback. Community hospitals have limited or no~     resources and staff dedicated to AS. Thus, understanding which of the core strategies is~     most feasible and effective in this practice setting would assist in appropriate allocation~     of limited resources. The purpose of this study is to evaluate the feasibility of~     implementing antimicrobial restriction and preauthorization vs. post antibiotic prescription~     review in resource-limited community hospitals.~   "
64520|NCT02212795|"~     Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of~     Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy~     volunteer~   "
64521|NCT02212782|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of~     Linagliptin after oral administration in healthy male volunteer.~   "
64522|NCT02212769|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of~     Losartan after oral administration in healthy male volunteer~   "
64523|NCT02212756|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of~     Metformin after oral administration in healthy male volunteer~   "
64524|NCT02212730|"~     This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab~     (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are~     that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and~     that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic~     infiltration in at least 30% of participants with RCC.~   "
64525|NCT02212717|"~     Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for~     surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage~     in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in~     treatment of this condition has been demonstrated but how the two procedures compare to one~     another is uncertain.~      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk~     patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize~     that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.~   "
64526|NCT02212704|"~     The purpose of this study is to evaluate the relative contribution of head- and trunk-based~     sensory systems to internal estimates of direction of gravity in healthy human subjects. To~     implement this assessment experimentally, the investigators will use a motor-driven~     3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted~     (±30°) or aligned with the trunk. The investigators will then obtain measurements of the~     subjective visual vertical in seven different whole-body roll positions (max. 90°~     roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The~     investigators hypothesize that different sensory input signals are combined in a~     statistically optimal fashion.~   "
64527|NCT02212691|"~     The purpose of this research is to use non-invasive imaging technologies to study how the~     human brain processes pain. The investigators will use contact heat to induce pain and~     record data scalp EEG and functional magnetic resonance imaging (fMRI). What the~     investigators learn from this study will help us gain insights in pain management with broad~     socioeconomic impacts~   "
64528|NCT02212678|"~     The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as~     therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.~   "
64529|NCT02212665|"~     The aim of the study 'Live - without diabetes' is to investigate the effects of increased~     physical activity on a daily basis with or without (high intense interval training) HIIT~     (short and intense: 3 minutes per week) during 12 weeks in risk individuals with~     pre-diabetes~   "
64557|NCT02212301|"~     This study is comparing two silicone hydrogel contact lenses in a controlled environment for~     identification of characteristics associated to vision.~   "
64530|NCT02212652|"~     VISTA is looking to see if vitamin D supplements before bariatric surgery might improve~     vitamin D stores, which may help to prevent some complications like infections.~      Who can join this research study?~        -  Approved to undergo bariatric surgery—Roux-en-Y Gastric Bypass or Vertical Sleeve~          Gastrectomy—at the Johns Hopkins Bayview Medical Center~        -  18 to 64 years of age~        -  BMI of 35 to 49.9 kg/m2~        -  VitD insufficient or deficient prior to having surgery~      What will happen if a participant chooses to participate in this research study?~        -  The participant will be randomly assigned (by chance) to receive either:~        -  Standard care plus vitamin D supplements or~        -  Standard care plus a placebo (contains no vitamin D)~        -  Either would be provided at no cost to the participant~        -  The investigators will ask the participant to complete a survey on the day of surgery~          regarding supplement use~        -  The investigators will follow the participants medical record through the 12 month~          follow up clinic visit.~   "
64531|NCT02212639|"~     Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with~     human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best~     30-60% of transient responses. While interferon responses are frequent, this drug is often~     poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS~     represents an ideal model for evaluating new drugs since patients do not receive concomitant~     immunosuppressive regimens nor antiviral therapies.~      Hypoxia-inducible factor 1(HIF-1 alpha) is a major regulator of solid tumor growth and~     therefore a suitable target currently explored in many cancers. Moreover HIF-1 alpha~     enhances HHV-8 gene expression in KS and induces lytic replication cycle. Digoxin has anti~     cancer effect in vivo through HIF-alpha down regulation in several preclinical tumor models~     including KS. The identification of HIF-1 alpha as a key factor in HHV8 replication prompt~     us to explore inhibition of HIF-1 alpha by digoxin as a potential therapeutic approach for~     KS treatment it has and consequently may down regulate HHV-8 replication in KS. This latter~     approach is heightened by recent data suggesting that Digoxin has some efficacy in vitro~     against others human herpes virus i.e. Herpes simplex and Cytomegalovirus (8) (9)~      In this study the investigators shall evaluate the benefit and safety profile of digoxin in~     classic and endemic KS (serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years~     and between 0.5-0.8 ng/ml in patients older than 75 years The participants will take study~     drug digoxin, for a total of 6 cycles (4 weeks/cycle).~   "
64532|NCT02212626|"~     The objective of this study is to evaluate the safety and efficacy of recanalization of~     acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub~     Medical)~   "
64533|NCT02212613|"~     The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive~     treatment in subjects with Major Depressive Disorder with irritability~   "
64534|NCT02212600|"~     The proposed project will be a multi-centre, prospective observational study to determine~     the prognosis and determinants of functional outcomes of patients with proximal humerus~     fractures. Approximately 10 centres will participate in this observational cohort, each~     enrolling at least 50 patients over the course of 2 years.~   "
64535|NCT02212587|"~     The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce~     the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum~     of cystic fibrosis patient.~   "
64536|NCT02212574|"~     Participants enrolling on this study will receive standard of care chemotherapy for Wnt~     positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is~     given during radiation therapy.~   "
64537|NCT02212561|"~     The purpose of this study is to test the safety of selinexor (KPT-330) and to find the~     highest dose of selinexor (KPT-330) that can be given safely when it is combined with two~     chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase~     I and Phase II.~      The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can~     give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine.~      The goal of the Phase II portion of the study is to give the highest dose of selinexor~     (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe~     for children with leukemia or MDS. The investigators will examine the effect of this~     combination treatment.~      PRIMARY OBJECTIVE:~        -  Determine a tolerable combination of selinexor, fludarabine, and cytarabine in~          pediatric patients with relapsed or refractory hematologic malignancies included acute~          myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute~          leukemia (MPAL) and myelodysplastic syndrome (MDS).~      SECONDARY OBJECTIVES:~        -  To characterize the pharmacokinetics of selinexor, when administered in tablet form,~          after the first dose and at steady-state, as well as in combination with fludarabine~          and cytarabine~        -  To estimate the overall response rate of selinexor given with fludarabine and~          cytarabine in patients with relapsed or refractory hematologic malignancies~   "
64538|NCT02212548|"~     This is a Phase I prospective study of 30 patients to determine whether PEG hydrogel~     (SpaceOAR) reduces the dose of radiation delivered to the rectum during Image Guided~     Intensity Modulated Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space~     between the prostate and the rectum.~   "
64539|NCT02212535|"~     The purpose of this study is to assess the tolerance and efficacy of mobilizing~     hematopoietic stem cells after a single injection of plerixafor (0.24mg/kg) in 3 adult~     patients (or 5, if results of the first 3 patients are not reproducible) affected by sickle~     cell disease.~   "
64558|NCT02212288|"~     To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim~     of the present study is to investigate oxidative stress in PKU with more comprehensive~     methods.The relationship between oxidative stress and metabolic disturbances~     (hyperPhenylalaninemia) will also be studied.~   "
64559|NCT02212275|"~     The investigators overarching aim is to obtain preliminary data to support a larger grant to~     validate a novel objective, physiologically-based outcome measure for clinical trials in~     autism spectrum disorders (ASDs) called the cortical metric. Absence of such an outcome~     measure has greatly hindered the development of treatments for core symptoms of ASD.~   "
65094|NCT02205307|"~     This is a randomized, controlled, parallel, multicenter study to determine the difference in~     post-operative anastomotic leak rate in low anterior resection procedures where colon and~     rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical~     practice compared to surgical procedures performed according to standard surgical practice~     alone.~   "
64540|NCT02212522|"~     The aim of this study is to complete the identification of genetic factors (G) and to~     undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by~     constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G~     analysis (whole genome genotyping done once a patient using methods conually updated at~     Centre National de Genotype) and innovative E analysis to develop the following long term~     objectives :~        -  Identify G and E factors influencing the process of remaining beta cells' destruction~          during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years~          diabetes duration);~        -  Identify G factors (pharmacogenomics) of the individual response to insulin using the~          effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D~          patients with negative C-peptide and well managed diabetes);~        -  Undertake a prospective research of G and E risk factors of death in bed syndrome in~          diabetic adolescents;~        -  Undertake a prospective research of G and E risk factors of incipient glomerular~          microangiopathy (regule measurement of microalbuminuria).~   "
64541|NCT02212509|"~     The aims of the cohort study is to describe the rates of 30-day surgical complication,~     functional decline, frailty and one-year mortality for patients experienced cardiac surgery~     and to delineate the trajectory of functional capacity 1 year after surgery for the~     patients. It also will test whether the trajectory of functional varied significantly~     according to delirium status and its type over the follow-up period and examine the~     patients' postsurgical actual caloric/protein/fluid intake in relation to the functional~     capacity within 3 months after surgery as well as evaluate whether activity levels, dietary~     diversity, and depressive symptoms at 3,6, and 12 months affect patient outcome.~   "
64542|NCT02212496|"~     Although there has been increasing interest in the association between cancer and~     cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is~     still not fully understood. The aim of this study is to investigate the stroke mechanisms in~     patients with cancer-associated stroke.~   "
64543|NCT02212483|"~     Asthma is one of the most prevalent chronic respiratory diseases, with potential~     lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases~     per year in France, and constitutes a public health problem in our country as in many~     countries in the world. The economic burden of asthma is also very high, in terms of health~     care, and indirect costs including lost work and lost school days.~      A few international and French studies have shown a positive clinical impact of Medical~     Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics.~     It has been proposed that MIECs could contribute to reduce patient exposure to many~     allergens and irritants, among them, house dust mite allergens, formaldehyde or molds. Most~     of the studies that show a significant decrease of hospitalization or visit in an emergency~     ward for asthma are monocentric and study the eviction of 1 such identified risk factor. By~     contrast, meta-analysis underline that additional studies are needed to evaluate the~     effectiveness of these interventions in adults, in a multicentric and controlled manner,~     with both clinical, environmental and economical endpoints.~   "
64544|NCT02212470|"~     The purpose of this study is to evaluate whether the results of drug eluting balloon are~     equivalent to the Nitinol stent implantation in the Superficial Femoral Artery.~   "
64545|NCT02212457|"~     The main purposes for conducting the study are firstly to assess immunological~     non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to~     healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine~     (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give~     the flexibility for the national vaccination program by showing the safety and~     immunogenicity of MenABCWY administrated according to four different vaccination schedules~     and additionally to evaluate a potential benefit of the 3-dose vaccination series.~   "
64546|NCT02212444|"~     Plantar fasciitis (severe pain in the heel) is a common problem that has a significant~     impact on quality of life. There is some evidence to support the use of orthoses and~     stretches in the conservative management of plantar fasciitis but current orthotic~     management may not be optimal. More prolonged stretching with night splints may achieve~     better results but such splints are clinically not well tolerated. Therefore, there is a~     potential need to apply prolonged stretching during the day and during dynamic tasks such as~     walking. This has led to the development of other rigid and semi-rigid splints that have~     shown promising results in small scale clinical trials. There are disadvantages however with~     the more rigid bracing and orthoses seen in these types of splints. For example, they are~     often difficult to accommodate with a person's available shoes; this can be particularly~     difficult for women and thus limits their compliance with the intervention. Further, more~     rigid bracing can be uncomfortable during fast walking and running and so limits~     participation in such activities.~      Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been~     developed. Being made from lycra® based materials the sock-like splint is lightweight and~     discrete, allowing it to be accommodated easily into most shoe types and potentially better~     tolerated when worn at night compared to currently available splints. Its design further~     allows it to be used comfortably during dynamic tasks such as walking and running as~     supported by initial anecdotal evidence in athletes. To date there has been no evaluation~     into the effectiveness of the DEFO in the general population with plantar fasciitis.~      This study will look at the feasibility of conducting a randomised controlled trial into the~     use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.~   "
64547|NCT02212431|"~     The morbidity and mortality associated with Cystic Fibrosis (CF) are the result of chronic~     suppurative lung disease. The aggressive use of antibiotics is one of the mainstays of~     treatment in CF, however, the problems of multiple drug resistance and adverse reactions are~     major clinical issues.~      Cysteamine is a licensed drug used in the treatment of cystinosis. In vitro work suggests~     that cysteamine has properties of potential benefit in CF. Cysteamine is a potent mucolytic,~     it disrupts biofilms, it is antimicrobial, and synergises with other antibiotic agents. CF~     is characterised by malabsorption and it is not known whether cysteamine is absorbed in CF,~     furthermore it is not known if cysteamine enters the bronchial secretions. It is not~     possible to assume that the pharmacokinetics of cysteamine in patients with CF are the same~     as those reported for cystinosis.~      Objectives: to characterise the pharmacokinetic profile of cysteamine in people with CF, to~     ascertain whether cysteamine enters the bronchial secretions and the tolerability of~     cysteamine by patients with CF.~      Method: a single centre, single group open label investigation of the tolerability and~     pharmacokinetics of oral cysteamine (Cystagon) when administered to patients with Cystic~     Fibrosis at the dose licensed for use in cystinosis.~      Setting: adult CF clinic, Aberdeen Royal Infirmary.~      Target population: 12 patients aged ≥18years with CF associated lung disease who are~     clinically stable.~      Intervention: Oral cysteamine (Cystagon) will be increased from 450mg od to 450mg qds over~     three weeks, they will remain on 450mg qds for two weeks.~      Assessment: face to face health outcome assessments will be carried out for all participants~     at recruitment/baseline, 1, 2, 3, and 5 and 6 weeks. Serial blood cysteamine levels will be~     measured in the first 24 hours after the first dose. Sputum cysteamine will be quantified~     after two weeks of full dose cysteamine 450mg qds. Disease specific health status (CFQ-R)~     will be assessed at baseline and after two weeks of full dose. At each assessment, lung~     function (FEV1, FVC), adverse reactions and serious adverse events will be ascertained.~     Blood samples will be taken for measurement of haematological and biochemical parameters.~     Sputum samples at each assessment will be analysed for microbial load and spinnbarkeit.~   "
65632|NCT02198274|"~     Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled~     sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12~     administrations) in patients with metastatic colorectal cancer.~   "
64548|NCT02212418|"~     Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic~     floor dysfunctions in the postpartum. In the last years it has been extended out of such~     medical context but there is a lack of scientific evidence, and the endurability of the~     effects of this technique are unknown. The investigator´s aim was to evaluate the effect of~     a 12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary~     incontinence, in women out of the postpartum phase. In addition the investigators looked for~     the endurability of its effect.~      Methods: The investigators performed a cross-over blinded intervention study of 4 month~     duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no~     AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2~     months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2~     months versus AHT.~      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,~     as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired~     as adequate.~   "
64549|NCT02212405|"~     Findings from this study may demonstrate how the insula contributes to reward pathways~     involved in addiction. There are three main hypotheses for this trial. The first is that~     inhibiting the insula using transcranial magnetic stimulation (TMS) will not cause~     noticeable changes of dopamine release in the striatum. The second is that stimulating the~     insula with TMS will increase dopamine release in the striatum, and will be visualized on~     PET imaging as decreased radiotracer binding. The third hypothesis is that the participants~     will not experience major side effects from TMS on the insula.~   "
64550|NCT02212392|"~     The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections~     and shorter hospital stay in patients of acute pancreatitis as compared to controls.~   "
64551|NCT02212379|"~     This multicenter, international, non randomized (single arm), open, phase II trial aims to~     evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological~     success in virologically suppressed HIV-1 infected patients, of at least 45 years of age,~     switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks.~     Measurement of primary endpoint will be at 48 weeks. Virological success is defined as the~     absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks of a dual~     raltegravir/etravirin regimen. Raltegravir/etravirine will be considered acceptable if the~     percentage of patients in virological success at week 48 is significantly above 90 %.~     Assuming a 95 % virological success rate, by including 160 individuals and considering the~     strategy to be acceptable if no more than 8 individuals have virological failure;~     investigators will have a 95 % probability to discard a combination for which efficacy is~     smaller than 90 % and investigators will select with a power of 80 % the strategy for which~     the efficacy is above or equal to 95 %. The principal secondary endpoint is the proportion~     of patients in therapeutic success up to week 48 and 96.~   "
64552|NCT02212366|"~     Late Life Depression (LLD) is a serious health problem which not only causes depressed mood~     but also results in impairments in memory and attention. These impairments are likely to be~     resistant to treatment, which increases the chances of developing dementia even after~     successful treatment of mood.This study is a randomized controlled trial of transcranial~     Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after~     successful treatment of mood with established medications. tDCS is non invasive, relatively~     inexpensive and portable, and has been found to be safe.This study also serves as a pilot~     study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition~     among patients with LLD. Primary study hypothesis is that participants Participants~     randomized to tDCS will perform better on a working memory task 2 weeks and 3 months~     following the tDCS course.~   "
64553|NCT02212353|"~     This small observational study is a contractual component of a 5-year (2013-18) NIHR funded~     programme called PERFECTED (Peri-operative Enhanced Recovery hip FracturE Care of paTiEnts~     with Dementia) whose overall aim is to develop and pilot an evidence-based intervention to~     improve the hospital care of patients with dementia suffering a fractured hip. The findings~     from this particular observational study will support other PERFECTED work-packages in~     establishing current care practices in acute hospital settings for older people in general~     with hip fractures.~      Observation is a well-established qualitative technique widely used to understand cultures,~     processes and interactions in defined locations including hospitals. In this study,~     researchers will observe day-to-day practices on specific ortho-geriatric wards and~     Emergency Departments in three English hospitals (Norfolk and Norwich University Hospital,~     Bradford Royal Infirmary and Queen's Medical Centre in Nottingham). Observations will occur~     intermittently over a 4-week period, covering the full 24h cycle. The prime objective of the~     study is to describe delivery of care to older patients with a hip fracture including an~     assessment of cost consequences. Crucially, the observations will focus exclusively upon the~     hospital personnel that routinely provide care in the designated locations being observed.~     Other individuals who frequent the locations (patients, visitors and other more peripheral~     health care professionals) are NOT the focus of the research and will be regarded as~     incidental others rather than participants. This approach is common in observational~     research.~      Observations will be conducted by experienced qualitative researchers and assisted by~     specifically trained lay researchers to provide a valuable service-user dimension to the~     study. Field-notes and contextual information will be collected and thematically analysed,~     again in partnership with trained 'lay' researchers. Resulting data will address the~     pre-defined aims of the observational study and feed into the findings reported across the~     whole of work package 1 of PERFECTED.~   "
64554|NCT02212340|"~     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely~     used, and there are many clinical trials comparing these on various aspects of anesthesia.~     However, there have not been studies comparing the quality of recovery from the different~     methods of general anesthesia in vitrectomy. In this study, the investigators compare the~     functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40~     questionnaire in vitrectomy.~   "
64555|NCT02212327|"~     The investigators' overarching goal is to improve long-term outcomes for end stage renal~     disease (ESRD) patients. In this study we focus specifically on patients receiving~     peritoneal dialysis (PD). Volume regulation in PD patients is related to hypertension, heart~     failure, nutritional status, and survival. Salt (NaCl) is the body's ion transport target to~     normally regulate volume via the kidneys; however, in hemodialysis (HD) patients the~     dialyser or in PD patients the peritoneal membrane, must serve that purpose. Determining~     volume status in PD patients is not easy and monitoring sodium (Na+) is more difficult~     still. The investigators have developed a novel, noninvasive approach to this problem~     involving 23Na+ magnetic resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in~     mostly the skin. Our technique measures Na+ in skin and skeletal muscle. In this study, we~     propose to apply this novel technique to PD patients.~      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls~     using Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency~     bioimpedance measurements and cross-sectional clinical data.~      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are~     increased in PD patients with volume expansion and in those patients with high soluble~     vascular endothelial growth factor receptor-3 (sFlt-4) levels.~      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal~     function in PD patients.~      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was~     found to have no utility in predicting preservation of residual renal function in PD~     patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will~     fulfill that function and will be inversely, rather than directly, related.~   "
64560|NCT02212262|"~     Progress in the treatment of myeloma and myeloma bone disease has substantially increased~     overall survival, but relapse is inevitable and better treatment is needed. The bone~     microenvironment is tremendously complex, so that targeting single interactions between~     tumor and bone is unlikely to be effective. Treatments need to block centrally important,~     multifunctional pathways. The investigators data point to a central role of the osteocyte to~     induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase~     due to FGF23 may make systemic inhibitors of heparanase less effective in bone than~     elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of~     FGF23 excess, such as chronic kidney disease (Shimada & Fukamoto, 2012), and could be used~     in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23~     has adverse effects, but neutralization of FGF23 excess may be practical, or in the future,~     suppression of excess FGF23 biosynthesis by osteocytes.~      The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho~     levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls~     with this exploratory study.~   "
64561|NCT02212249|"~     Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune~     disease with a endothelial dysfunction. This study is to evaluated the level of soluble~     VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.~   "
64562|NCT02212236|"~     This Phase II trial aims to evaluate a new psychological intervention to alleviate distress~     during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.~      HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses.~     Over 3,000 individuals undergo the procedure every year in the UK with substantial benefits.~     However, it is very costly, intensive, and has a range of debilitating side effects.~     Consequently, patients often experience considerable distress, which can impede recovery.~      A 90-minute, group-based intervention has been developed to address this need based on~     psychological theory of adjustment to illness-related difficulties. It is delivered by the~     transplant team and involves provision of information to foster more helpful perceptions~     about HSCT and facilitating more helpful coping with its difficulties. To evaluate the~     effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT~     at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients~     in the intervention group will receive the new intervention prior to transplantation~     together with treatment as usual (TAU) while patients in the control group will receive TAU~     alone. Participants and the researcher collecting the data will be blind to the allocation.~      Demographic and relevant clinical information will be recorded at the end of participation~     to ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and~     procedure-related perceptions will be measured at four time points: (i) prior to the~     intervention/transplantation, (ii) day of transplant, (iii) two weeks following the~     transplant, and (iv) four weeks following the transplant. It is hypothesised that patients~     in the intervention group will experience higher resilience and lower distress compared to~     controls and that this difference will be mediated by procedure-related perceptions and~     coping. A subgroup of participants of those randomised to the group intervention will be~     invited to participate in a feedback interview at the end.~   "
64563|NCT02212223|"~     Insufficient intake of vitamin D is a public health problem, affecting about 40% of the~     Finnish population in the winter. Vitamin D has a wide range of health effects: in addition~     to its effect on bone, it is known to affect inflammatory response among other things. The~     sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.~     In Finland and in Northern Europe vitamin D is formed in the skin only from March to~     October. This alone is not sufficient to cover the need for year-round, because vitamin D~     storage is used in a few months. During the winter months the only sources of vitamin D are~     diet and vitamin preparations. Current vitamin D recommendations are usually based on~     studies in white population. However, there can be a difference in the need of vitamin D and~     in vitamin D metabolism between different population groups. More research evidence is~     needed from the northern countries. The aim of this study is to evaluate the vitamin D need~     in Somali immigrant population and in original Finnish population. The hypothesis is that~     the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than~     the original Finnish population.~   "
64564|NCT02212210|"~     The purpose of this study is to look to see if adding steroids to an epidural reduces the~     chances of having a fever in labor, and protects the baby from exposure to inflammation.~   "
64565|NCT02212197|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and~     safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will~     receive leuprolide acetate administered subcutaneously once monthly during 3 months.~   "
64566|NCT02212184|"~     The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on~     diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods:~     Randomized controlled trial (double blinded) with COPD patients, allocated in two group:~     intervention (IG) who will receive the Diaphragm Release manual technique on 6~     non-consecutive sessions and control group (CG), who will receive a sham protocol (light~     touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post~     treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will~     be the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will~     comprise abdominal and chest wall kinematics.~   "
64567|NCT02212171|"~     Background: With new challenges for healthcare, there is a clear consensus among experts on~     the need to introduce changes in the organization of care in health centres to address the~     problems of over-attendance, bureaucratization and other emerging issues that require~     growing amounts of attention. However, there has been insufficient research into possible~     models and the impact of their adoption.~      The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a~     new organizational model based on triage and healthcare mini-teams (two general~     practitioners/pediatricians, two nurses and one member of the administrative staff) compared~     to the current model, aiming to achieve a correct classification of the healthcare needs of~     the primary care population and direct them to the most suitable professional.~      In addition, the implementation research objective is to identify the facilitators for and~     barriers to the implementation of the intervention in the context of primary care.~      Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in~     14 healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the~     Basque Healthcare Service (Osakidetza) Interior Health Region.~      The results will be assessed using the data on morbidity-adjusted attendance of users to~     their family doctor, number of referral, addition of new activities to the portfolio of~     services, and patient perception and professional satisfaction. All the variables will be~     measured at baseline and at the end of the intervention, 24 months later.~      Using covariance analysis models, the investigators will estimate the effect attributable to~     the intervention by analyzing differences in changes between the two groups, and calculating~     the 95% confidence interval, adjusting the comparisons for baseline values. The~     investigators will also adjust for potential confounding and effect-modifying variables.~      Nominal groups will be held at the end of the intervention with the participation of all the~     agents involved in intervention centres to identify the facilitators for and barriers to the~     implementation of the intervention.~      Discussion: There is a need to develop new forms of organization in primary care services to~     respond to new healthcare demands. To pursue this aim, changes have to be introduced in the~     organization of healthcare within health centres, redefining the roles of primary care~     professionals and refocusing their activity towards population health needs, seeking greater~     efficiency in health services.~   "
65095|NCT02205294|"~     Osteopathic treatment will provide:~        1. A significant reduction of pain and swelling of the affected DVT leg~        2. An increase in the quality of life (QOL) for individuals with DVT of the leg~        3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg~   "
64568|NCT02212158|"~     The purpose of this project is to assess the feasibility and efficacy of a new group therapy~     program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c).~     This intervention is aimed at addressing issues frequently found to be associated with poor~     control: knowledge deficits, parental supervision, parent-teen communication and~     psychosocial barriers. In order to test this new group therapy program, adolescents' HA1c~     and psychosocial functioning will be monitored pre- and post-intervention. It is~     hypothesized that individuals who participate in the group therapy program will show an~     improvement in their HA1c levels and quality of life, self-efficacy, supportive behaviors~     from family members, readiness to make improvements in their diabetes care and decrease~     symptoms of depression.~   "
64569|NCT02212145|"~     To evaluate long-term effects of one individual- and population-oriented cardiovascular~     prevention programs in primary care.~   "
64570|NCT02212132|"~     This pilot study is, in this new and original approach in cancer pathology, measure and~     explain the correspondence between perceived cognitive impairment (cognitive complaint) by~     cancer patients and their cognitive scores goals with tasks metamemory while controlling the~     anxiety and depression and fatigue factors of patients.~   "
64571|NCT02212119|"~     Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on~     muscle tone, and caregiver burden in individuals who are cognitively impaired and who are~     fully dependent.~      The primary objective is to confirm proof of principle that paratonic rigidity and the~     consequences associated with it can be reduced with injection of Botulinum toxin injections~     resulting in reduced care-giver burden.~      The secondary objectives are to determine optimal time points for evaluation of efficacy in~     this patient population and whether the time period is sufficient for washout of Botulinum~     toxin effect; determine most salient and sensitive outcome measures; identify obstacles in~     data gathering; and lastly, to determine feasibility of battery of assessments in this pilot~     study.~   "
64572|NCT02212106|"~     This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent~     Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in~     children aged 5 years to less than 9 years. Comparison will be made to a licensed~     Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the~     2014/2015 influenza season in the US.~   "
64573|NCT02212093|"~     Severe pneumonia has a high in-hospital mortality. There are few studies which investigate~     the long-term mortality in patients that are discharged alive from the hospital. In this~     study we want to investigate the 5 years mortality after treatment of severe pneumonia in an~     ICU. We will also investigate the cause of death after discharge from the hospital.~   "
64574|NCT02212080|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,~     randomized, single center design. In addition the bioavailability of two different liquid~     formulations will be compared.~   "
64575|NCT02212067|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effects of~     semaglutide on ß-cell function in subjects with type 2 diabetes.~   "
64576|NCT02212054|"~     The present study was designed to compare the efficacy of conservative treatment to~     operative treatment for improvement of constipation symptoms in children with Hirschsprung~     allied disease~   "
64577|NCT02212041|"~     People with mental illness are more likely to smoke and are more severely addicted to~     nicotine than the general population. As a result, the number of deaths related to tobacco~     is higher.~      Smoking is highly addictive because it delivers nicotine very quickly. Research studies show~     that people who use nicotine replacement therapies (such us patches, gums, etc) are more~     likely to quit smoking than those who try to quit without using these nicotine products.~     Recently a new electronic nicotine delivery system (ENDS), also known as electronic~     cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices~     that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous~     chemicals contained in tobacco cigarettes.~      Given the increasing popularity of e-cigs, there is an urgent need to improve our~     understanding of both the potential benefits and risks of e-cigs use in people with serious~     mental illness. In this pilot we propose inviting 50 people with schizophrenia (or~     schizophrenia-related disorder) who are not intending to quit smoking in the near future to~     take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week~     period in which they will not receive free e-cigs and we monitor which products participants~     choose, and a final 24-week follow-up visit. During the 24-week study period we will assess~     the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants,~     nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms~     as well as the e-cigs perceived benefits and risks.~   "
64578|NCT02212028|"~     Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing~     recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial~     infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage~     of 60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its~     antiplatelet effects in this particular setting has been consistently shown. administration~     of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater~     bioavailability compared to the whole tablets has been observed. However, if the~     administration of a crushed prasugrel LD may overcome the above limitation is still unknown~     and represents the aim of our study. The proposed investigation will have a prospective,~     randomized, design in which STEMI patients undergoing primary PCI will be randomized to~     receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed~     tablets). Pharmacodynamic testing will be performed at several time points to test our study~     hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet~     inhibitory effects.~   "
64579|NCT02212015|"~     Open-label phase II trial investigating the efficacy and safety of the investigational~     combination of pazopanib and paclitaxel.~   "
64603|NCT02211703|"~     Study Objective:~        -  to project the incidence of perioperative hypothermia in patients with elective surgery~          under general anesthesia in China~        -  to determine the risk factors associated with perioperative hypothermia.~        -  to explore the patient outcome of hypothermia such as cardiovascular events, wound~          infection,hospital stay and so on.~      Study Design: The present study is a cross-sectional study with 30-day follow-up period.~   "
64580|NCT02212002|"~     The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is~     influenced by several factors, such as mode of delivery, gestational age, maternal~     intestinal and vaginal microbiota, type of feeding, hospitalization after birth and use of~     antibiotics and probiotics.~      Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low~     count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli,~     which positively influence the host's immunity processes; hence, is considered to be ideally~     healthy.~      Group B Streptococcus (GBS) represents one of the most important causes of neonatal~     infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process~     from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the~     last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the~     introduction of GBS universal screening during late pregnancy and consequent intrapartum~     antibiotic prophylaxis (IAP) in GBS-positive women.~      The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby~     impairing the balance between health and disease later in life. The effect of IAP on~     bacterial colonization of the infant's gut, however, has not been largely investigated. The~     investigators have previously evaluated the effect of IAP in a relatively small sample of~     exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at~     7 days of life there were several differences in microbiota composition between infants~     IAP-exposed and not exposed.~      This observational prospective study thus aims to evaluate these differences in further~     detail, expanding the initial sample to formula-fed term infants and following up infants~     until one month of age. By including formula-fed infants, the investigators additionally aim~     to evaluate the influence of feeding type on the neonatal microbiota composition.~   "
64581|NCT02211989|"~     To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332~     CL~   "
64582|NCT02211976|"~     Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl~     and simeticone compared with the efficacy and tolerability of the single products in~     patients suffering from constipation and bloatedness~   "
64583|NCT02211963|"~     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     44847 following administration of multiple rising oral doses over 8 days in patients with~     type 2 diabetes.~   "
64584|NCT02211950|"~     The objectives were to investigate the relative bioavailability of BI 44847 in different~     racial groups (white, Asian, and African subjects) and to investigate the effect of~     different types of diet and acarbose coadministration on the bioavailability of BI 44847 in~     white subjects.~   "
64585|NCT02211937|"~     Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.~     400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic~     (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40~     mg BI 44847 as tablet.~   "
64586|NCT02211924|"~     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847~     in Japanese healthy volunteers~   "
64587|NCT02211911|"~     To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in~     breast milk of healthy lactating women after an oral administration of 10 mg once daily over~     a period of 8 days.~   "
64588|NCT02211898|"~     To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of~     heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with~     swelling of calf and ankle due to disorder of leg venous reflux.~   "
64589|NCT02211885|"~     Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its~     metabolites including excretion and mass balance of parent compound and radioactivity; to~     isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine~     and feces~   "
64590|NCT02211872|"~     The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI~     2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of~     safety, efficacy, and pharmacokinetics of BI 2536 BS~   "
64591|NCT02211859|"~     Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic~     profile of BI 2536. Assessment of safety and efficacy.~   "
64592|NCT02211846|"~     The purpose of this study is to evaluate the pharmacokinetics as well as the safety and~     tolerability of mirabegron OCAS tablets after single-dose administration at different dose~     levels in children and adolescents with NDO or OAB.~   "
64593|NCT02211833|"~     Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated~     dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed~   "
64594|NCT02211820|"~     Background:~      - Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury.~     The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain~     scan to help diagnose CTE in living patients.~      Objective:~      - To determine if a new type of brain scan can detect changes that occur in chronic~     traumatic encephalopathy.~      Eligibility:~      - Adults age 18 60 with previous head injury or participation in certain sports.~      Design:~        -  Participants will be screened with:~        -  Physical exam~        -  Blood and urine tests~        -  Tests of thinking, mood, and memory~        -  30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves~          take pictures of the brain. Participants will lie on a table that slides into a metal~          cylinder. They will get earplugs for the loud knocking sounds.~        -  Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount~          of a radioactive chemical. That will be injected through an intravenous tube (catheter)~          in each arm. A catheter will also be put into an artery at the wrist or elbow.~        -  Participants will lie on a bed that slides in and out of a donut-shaped scanner. A~          plastic mask may be molded to their face and head. Vital signs and heart activity will~          be checked before and during the scan.~        -  Blood and urine will be taken before and after the scan.~        -  Participants will be checked on by phone the next day.~        -  Visit 2: Participants will repeat Visit 1 with a different chemical and no artery~          catheter.~        -  Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle~          between the bones in the back.~   "
64595|NCT02211807|"~     The purpose of this study was to compare the frequency of suicidality and suicide attempt~     among HIV patients starting treatment with Efavirenz and with patients starting treatment~     with other HIV medications.~   "
64596|NCT02211794|"~     Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.~   "
64631|NCT02211339|"~     The purpose of this study is to investigate whether a peer led social skills training~     intervention is more effective than a social activity group (i.e. usual care) in improving~     social skills following brain injury.~   "
64632|NCT02211326|"~     The purpose of this study is to determine whether the international pharmacogenetic~     algorithm is better than the standard initiation dosing and whether the two algorithms are~     suitable for Chinese elderly patients.~   "
64597|NCT02211781|"~     Background:~      - The National Cancer Institute has been studying health risks to people in New Mexico at~     the time of the first nuclear bomb test. This was called the Trinity nuclear test. It took~     place in 1945. Researchers want to also learn about Native Americans and Hispanics at that~     time. They want to learn about their way of life and their diets. This will give a more~     complete picture of the health risks to people in New Mexico in 1945.~      Objectives:~        -  To learn about the activities and eating habits of Hispanic and tribal communities~          during the 1940s.~        -  To see if a group of Hispanic and Native Americans who were living in New Mexico in~          1945 can be gathered.~      Eligibility:~      - Native American or Hispanic adults who were alive in 1945. They must know firsthand about~     the lifestyle and diet in New Mexico at that time.~      Design:~        -  Participants will have 1 visit. They will be interviewed at a place like a library or~          office. They will answer questions about their lifestyle and diet around 1945. This~          will take up 60 90 minutes.~        -  Participants may agree to have their interviews taped. Their names will not be kept~          with their answers from the interviews.~   "
64598|NCT02211768|"~     Background:<TAB>~      - Many people with neurofibromatosis type 1 (NF1) get tumors of the nervous system. Finding~     malignant tumors early is important for removing them. Researchers want to find ways of~     doing this with scans and genetic testing.~      Objectives:~      - To learn more about neurofibromatosis type 1.~      Eligibility:~      - People age 10 and older with NF1 who have a benign tumor or have had a malignant one.~      Design:~        -  Participants will be screened in another study with medical history, physical exam, and~          urine and blood tests. They will have a magnetic resonance imaging (MRI) scan.~        -  MRI: Participants will lie on a table that slides into a metal cylinder. They will be~          in the scanner for 60 90 minutes, lying still for 15 minutes at a time. Participants~          will get earplugs for the loud sounds. They will get a contrast agent (dye) through a~          thin plastic tube (catheter) inserted in an arm vein.~        -  As part of their regular care, participants will have:~        -  FDG-PET/CT scan. They will get radioactive glucose (sugar) through a catheter in an arm~          vein.~        -  [18F]-FLT-PET/CT scan. This is like the FDG scan but with a different radioactive~          chemical.~        -  Biopsy. A piece of tumor tissue is removed with a needle. A piece of tissue from a~          previous biopsy may also be studied.~        -  Participants may have genetic testing. Blood will be taken. It will be tested along~          with biopsy samples. Researchers will explain the risks and procedures. They may notify~          participants if testing shows health problems.~        -  After this study, participants will continue their regular cancer care.~   "
64599|NCT02211755|"~     Background:~      - Researchers want to develop better ways to treat cancer. In this study, they will give~     people with cancer two drugs. These drugs have been used on their own to treat some blood~     cell cancers.~      Objectives:~      - To test the safety and efficacy of the drug combination of bortezomib and clofarabine.~      Eligibility:~      - Adults age 18 and over with advanced cancer that has progressed after receiving standard~     treatment or that has no effective therapy.~      Design:~        -  Participants will be screened with medical history, physical exam, and scans to measure~          their tumors. They will also have heart, blood, and urine tests. All of these may be~          done by their regular doctors.~        -  Participants will get the study drugs in 21-day cyles. They will stay at the clinic for~          week 1 of every cycle, then have 2 weeks off.~      <TAB>- Bortezomib will be injected under the skin on days 1 and 4.~      <TAB>- Clofarabine will be injected in a vein for days 1 5.~        -  During cycle 1 only, participants will go to the clinic or their doctor to have a~          physical exam and blood tests at the start of the second and third week.~        -  Participants will have a clinical evaluation throughout the study, before the start of~          each cycle, before receiving treatment.~        -  Participants may stay in the study as long as they are tolerating the drugs and their~          tumor is not getting worse.~        -  Participants will have follow-up for 30 days after the last dose of study drugs.~   "
64600|NCT02211742|"~     Dapagliflozin is a highly selective, reversible and potent inhibitor of the~     sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use~     as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an~     increased glucosuria, and it was shown that mean blood glucose concentrations and~     postprandial glucose excursion in special were significantly reduced in type 2 diabetic~     patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients~     will benefit from dapagliflozin. The present study is focused on the effects of~     dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type~     1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin~     and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind,~     randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic~     clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp~     tests (postprandial glucose excursions).~   "
64601|NCT02211729|"~     The primary objective of this study is to determine whether addition of azithromycin (AZ) to~     Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine~     (AQ) will provide an additional reduction in deaths and severe illness in young African~     children. The secondary objectives include an assessment of the safety and~     cost-effectiveness of the addition of AZ to SMC with SP+AQ.~      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be~     the household. Children aged 3 - 59 months will be randomised to receive four cycles of~     either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission~     season.~      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of~     3-59 months of age at the start of each period of drug administration will be eligible for~     inclusion in the trial provided that parental consent is obtained. Children with a severe,~     chronic illness or known allergy to one of the study drugs will be excluded.~      Primary endpoint: Incidence of the combination of death or hospital admission for at least~     24 hours, not due to trauma or elective surgery during the intervention period~      Secondary endpoints:~        1. incidence of the primary endpoint during the whole study period~        2. attendance at a study health centre with a nonmalaria febrile illness~        3. attendance at a study health centre with malaria,~        4. the prevalence of moderate anaemia at the end of each malaria transmission season,~        5. nutritional status at the end of each malaria transmission season,~        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant~          pneumococci before and at the end of each malaria transmissions season,~        7. prevalence of resistance markers to SP at the end of the study,~      Sample size: 19,200 children (9600 in each country) will be enrolled.~   "
64602|NCT02211716|"~     The objective of this clinical investigation is to evaluate, in a controlled setting, the~     long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System~     (Bentley InnoMed) in clincial settings post CE-certification when used according to the~     indications of the IFU.~   "
65697|NCT02197416|"~     This open-label, single arm prospective cohort study will assess the safety of dabigatran~     etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children~     from 0 to less than 18 years of age will be eligible to participate.~   "
64604|NCT02211690|"~     This study aims to describe the proportion of participants with non-occupational~     post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to~     follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants~     who should and do cease study drug because:~        1. The participant is found to be HIV-infected (study drugs will be ceased until the~          genotype of the infecting strain is determined)~        2. The source is found to be HIV-uninfected~      The primary study objectives are:~        1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using~          dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)~        2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)~          using dolutegravir with co-formulated emtricitabine-tenofovir~      The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)~     eligible participants will receive dolutegravir (one tablet) with co-formulated~     emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following~     exposures:~        1. receptive anal intercourse with a source known to be HIV-infected; or~        2. receptive anal intercourse with a source of unknown HIV status; or~        3. insertive anal intercourse with a source known to be HIV-infected~      There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.~     to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed~     at the investigator's discretion.~   "
64605|NCT02211677|"~     RATIONALE~        1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between~          actual clinical outcome and TNM stages because it is an anatomy-based system in which~          functional factors are not concerned.~        2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve~          prognosis prediction of TNM staging system in our previous retrospective study.~      PURPOSE To validate that the prognostic index based on complete blood count and TNM system~     had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system~     alone.~   "
64606|NCT02211664|"~     The objective of this clinical investigation is to evaluate the short- and long-term (up to~     24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing~     balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal~     arterial stenotic or occlusive lesions.~   "
64607|NCT02211651|"~     The purpose of this study is to discover the characteristics of pregnant women which~     increases risk for their babies to develop diabetes, later on in life.~   "
64608|NCT02211638|"~     The puropose of this study is to gain an understanding of the actual use of candesartan~     cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters~     such as blood pressure.~   "
64609|NCT02211625|"~     The primary objective of this study is to evaluate the safety, tolerability,~     pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A)~     and as multiple ascending doses (Part B) in healthy subjects.~   "
64610|NCT02211612|"~     To investigate metabolic and molecular response to fatty acid-specific overfeeding in~     overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin~     sensitivity~   "
64611|NCT02211599|"~     The purpose of the study is to determine how adding a carbohydrate beverage to a meal with~     different protein levels affects the rate at which one's body burns fats, sugars, and~     proteins.~   "
64612|NCT02211586|"~     The purpose of this study is to see what effect this investigational drug has on the body,~     and whether it causes a change to how your body uses fats and sugars as fuel sources.~   "
64613|NCT02211573|"~     Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains~     the leading cause of mortality in the industrialized world. In order to reduce the~     deleterious effects of the atherosclerotic process, proposals for non-pharmacological~     treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise~     -based therapy. Traditionally aerobic exercises like biking, walking and jogging are~     conducted, however, alternative ways such as aquatic exercise training have been proposed,~     however, the cardiorespiratory adaptations in this population are not well documented in the~     literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic~     training (AAT) on body composition, autonomic modulation of heart rate (HR) and~     cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal~     clinical trial with a sample allocated for convenience, in which twenty-one patients were~     male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8),~     who was only assessed, and training group (TG, n=13). All patients underwent assessment of~     body composition, heart rate variability (HRV) at rest in the supine posture, and~     cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The~     training protocol consisted of three sessions per week on alternate days for 16 weeks,~     totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was~     prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET.~     Given that these parameters represent risk markers for cardiovascular events in the~     population studied, the results suggest that the AAT proposed in this study may be an~     important therapeutic strategy to be incorporated into cardiac rehabilitation programs.~   "
64614|NCT02211560|"~     The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on~     cognitive abilities in MCI~   "
64615|NCT02211547|"~     The primary goal of the study is to determine if there is a difference in pain levels~     following the use of low level laser therapy versus placebo and control after placement of~     elastomeric orthodontic separators in pediatric patients. To test this, the investigators~     will assess the patient's pain levels immediately following separator placement and 24 hours~     post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS).~     Patients will be randomly assigned to one of three groups: treatment, placebo, and control.~     The aim of this study is to establish whether or not low level laser therapy can be used to~     reduce pain in pediatric patients following separator placement.~   "
64616|NCT02211534|"~     The purpose of this study is to investigate whether pulsed electromagnetic energy field~     (PEMF) therapy is effective in the treatment of persistent pain following total knee~     arthroplasty (TKA)~   "
64617|NCT02211521|"~     The purpose of this study is to compare the efficacy of platelet-rich plasma versus~     hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee~     joint.~      The hypothesis is that PRP intra-articular injection is comparable or even better than~     hyaluronic acid injection.~   "
64618|NCT02211508|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients~     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up~     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 200~     fibromyalgia patients will be randomized into one of two study groups. One of these groups~     will receive sham treatment, meaning they will receive no treatment at all, while the other~     group will receive active RINCE treatment. The study's primary outcome measure will be the~     difference between active and sham treatment groups in the mean change from baseline in~     patients' weekly worst pain scores. The study's hypothesis is that there will be a~     difference between treatment groups in primary outcome measure.~   "
64619|NCT02211495|"~     The investigators hypothesise that use of a medical device, that increases blood flow to the~     foot, will speed up ulcer healing in symptomatic diabetes~   "
64620|NCT02211482|"~     The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of~     dual therapy with 3TC and DTG as initial therapy among naïve HIV patients~   "
64621|NCT02211469|"~     The primary objective in this study is to assess if single doses of BMS-986104 that are~     safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute~     lymphocyte count) can be achieved without bradycardia or other adverse events in healthy~     male subjects.~   "
64622|NCT02211456|"~     We are investigating ways to help patients with heart failure, which is caused by damaged~     hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of~     energy and swelling.~      Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function~     of the main heart chamber in certain suitable people with heart failure. CRT requires a~     pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on~     the outside of the left heart chamber. These two wires act together to re-time the~     coordination of the heartbeat, which is known to improve heart function.~      The investigators are assessing whether they might be able to improve heart function even~     more by placing two wires on the inside of the left heart chamber, rather than one around~     the outside.~      The investigators wish to assess whether:~        1. Using two wires within the left side of the heart gives a greater increase in heart~          function than one.~        2. It is possible to choose the best spot inside of the heart by measuring the pattern of~          the heart beat.~        3. Is it possible to use a different type of heart monitor placed outside the body instead~          of a monitor wire inside the heart to assess improvement in heart function? They are~          investigating this in people with hearts that beat less effectively than normal.~   "
64623|NCT02211443|"~     The purpose of this study is to determine whether SCT200 is safe and tolerant in the~     treatment of metastatic colorectal cancer~   "
64624|NCT02211430|"~     To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant~     women to 90%, new methods for treating nicotine addiction among pregnant women are needed.~     To this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation~     intervention for low-income, minority women conducted in the prenatal and postpartum phases.~     Considering the strong link between tobacco use and cancer risk, the development of~     effective smoking cessation treatments has important health implications for cancer~     prevention and control initiatives. The aims to be addressed are:~      Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation~     intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e.,~     continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short-~     and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show~     reduced rates of tobacco use, versus those in the BP, over time.~      Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of~     behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced~     fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is~     hypothesized that the psychosocial factors will mediate the effect of the CBC intervention~     on change of smoking behaviors.~   "
64625|NCT02211417|"~     This study will compare the safety and efficacy of DS107G (2 g) to placebo in patients with~     moderate to severe atopic dermatitis.~      DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against~     placebo.~      This study will enroll approximately 100 adult patients.~   "
64626|NCT02211404|"~     Prospective evaluation of sleep in children admitted to the Intensive Care Unit at~     Nationwide Children's Hospital to determine how children sleep while admitted to the~     Intensive Care Unit~   "
64627|NCT02211391|"~     Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will~     be measured with the microdialysis technique by measuring glycerol concentration and blood~     flow in abdominal adipose tissue. Morning fat oxidation will be measured with indirect~     calorimetry.~      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis~     rate compared to casein protein and a non-caloric placebo. The investigators also~     hypothesize that casein and placebo will not be significantly different from each other in~     terms of overnight lipolysis.~   "
64628|NCT02211378|"~     This randomized controlled trial aims to determine if the stress response and performance of~     trainees who are observers in simulation training is similar to trainees who are actively~     participating in simulation training in the 'hotseat' during 3 consecutive simulation~     sessions.~      We hypothesize that trainees experience less stress when they are observers in the first 2~     simulation sessions. However, when they are placed in the 'hotseat' during the third~     session, their stress response, as well as their performance, will be similar to trainees~     who spend all 3 simulation sessions in the 'hotseat'.~   "
64629|NCT02211365|"~     The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the~     management of essential hypertension by integrating the activity of general practitioners~     (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously~     allocated in the regional area, and the Hypertension Clinic of the Federico II University in~     Naples, which served as co-ordinating centre. Through the RCSN system it is possible to~     store clinical data detected at each visit between the peripheral units and the~     co-ordinating centre and to support scientific analysis of the dataset.~   "
64630|NCT02211352|"~     The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease~     central blood pressure in subjects with hypertension.~   "
64633|NCT02211313|"~     A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as~     treatment of urinary stone disease. Stents are designed to help provide drainage of the~     kidney in the setting of an obstructing stone, or postoperative swelling of the ureter.~     Though their presence is only temporary, stents are associated with a significant amount of~     patient discomfort and bother, which can negatively impact overall satisfaction. Over the~     past decades, there have been refinements in stent technology and usage philosophy. Smaller~     and softer stents are now available for use in patients, though studies evaluating the~     relative benefits have been conflicting. The investigators aim to evaluate the effect of~     stent size and composition upon outcomes after the treatment of stone disease, including~     patient comfort and satisfaction.~   "
64634|NCT02211300|"~     The objective of this study is to demonstrate that the OptiScanner® is safe and can provide~     accurate blood glucose levels in critically ill subjects.~      Accuracy Hypothesis:~      The assessment of blood glucose level that results from the OptiScanner is comparable to the~     YSI 2300 STAT Plus™ Glucose and Lactate Analyzer (YSI Analyzer; YSI Life Sciences, Yellow~     Springs, OH).~      Safety Hypothesis:~      The OptiScanner has an acceptable risk/benefit profile for a system that can provide~     repeated automated blood glucose levels for critically ill subjects.~   "
64635|NCT02211287|"~     The purpose of this study is to evaluate the application of a best-practice Advance Care~     Planning (ACP) model for individuals living with dementia in a sample of nursing homes in~     Northern Ireland~   "
64636|NCT02211274|"~     Older adults prefer to live as in the community as long as possible. Creating a standardized~     treatment planning process that includes assessments of everyday competence and goal-setting~     techniques to help Veterans move from VA nursing homes back to the community can improve~     functional health, well-being, and quality of life for older Veterans. Research has shown~     that 29% of nursing home residents might be able to live safely in the community instead.~     Currently, VA provides nursing home care to more than 13,000 Veterans across the country,~     which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care~     to these inappropriate residents and they are using limited resources that could be given to~     another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for~     Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the~     community with the services and supports they need based on their individual level of~     everyday competence.~   "
64637|NCT02211261|"~     A first in human study to determine the safety, tolerability and pharmacokinetics of single~     and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus~   "
64638|NCT02211248|"~     Analyzing cardiovascular evaluation measures in the multidisciplinary and in the~     conventional treatment of hypertensive patients will provide better parameters for comparing~     the two approaches.~   "
64639|NCT02211235|"~     Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes~     recommend treatment for diabetes based on diagnostic criteria derived from adults with type~     2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic~     fibrosis patients to target CF specific outcomes, including lung function and nutrition~     (BMI). However, the criteria and timing of when to start insulin therapy in the~     `prediabetic' state are unclear. A more accurate characterization of blood sugar variability~     in youth with and without CF will help us better interpret continuous glucose monitor (CGM)~     findings in patients with CF prediabetes and diabetes and more accurately identify those~     individuals at greatest risk for disease progression.~   "
64640|NCT02211222|"~     This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization~     Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria~     will be treated. These subjects will be treated until progression of disease or unacceptable~     toxicity.~   "
64641|NCT02211209|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for~     52 weeks in patients with Familial Chylomicronemia Syndrome~   "
64642|NCT02211196|"~     This pilot clinical trial studies evidence-based tobacco cessation strategies in patients~     with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit~     smoking.~   "
64643|NCT02211183|"~     This is a post-marketing study to further assess the safety and effectiveness of the~     InSpace™ device implantation in comparison to surgical repair of full thickness Massive~     Rotator Cuff Tear .~   "
64644|NCT02211170|"~     Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory~     responses induced by endotoxin in healthy humans~   "
64645|NCT02211157|"~     Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating~     multiple doses with and without a 64 g fat breakfast at the 50 mg dose level~   "
64646|NCT02211144|"~     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as~     multiple daily doses at various dose levels~   "
64647|NCT02211131|"~     This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of~     talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery~     alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.~   "
64660|NCT02210962|"~     There is accumulating experimental evidence to suggest the role of essential fatty acids~     (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to~     be dysfunctional on early stages of schizophrenia, according to neurodevelopmental~     hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich~     diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular~     importance at the beginning of the illness. As a relatively safe option, EFA supplementation~     would be a preferable add on therapy in treating individuals with a first episode of~     schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up~     studies of EFA supplementation in FES patients were carried out. The demonstration of the~     efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would~     be a strong basis for further studies and prescribing EFAs for a large population of~     patients who are in the early stages of that debilitating illness.~   "
64661|NCT02210949|"~     Pre-treatment of patients with erythropoietin subcutaneously and iron supplement~     intravenously, in order to create a clinical pathway to minimize transfusion of red blood~     cells in a selected group of cardiac patients with an increased risk for blood transfusions~     in our cardiac surgery program.~   "
64648|NCT02211118|"~     A variety of medications have been used to treat the anxiety, discomfort, and fear~     associated with continuous and sudden episodic breathlessness in patients with advanced~     respiratory disease. Opioids and benzodiazepines, used alone or in combination, are commonly~     prescribed for this distressing symptom. Clinicians are concerned about the adverse effects~     of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines.~     Recent studies have shown that benzodiazepine use is associated with increased adverse~     respiratory outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).~      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.~     Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without~     respiratory depression or cognitive dysfunction. The drug can be administered intranasally~     to induce light to moderate sedation of several hours duration.~      The objective of the proposed research, a pilot study, is to assess the dose dependent~     safety and efficacy of intranasal dexmedetomidine in clinically stable patients with severe~     COPD. This will be accomplished in a staffed acute care setting with routine vital signs~     monitoring and pulse oximetry. Patients will be assessed objectively and subjectively for~     their level of sedation by validated sedation scales.~      This pilot study is an initial investigation of a drug with favorable pharmacologic~     properties in this patient population with distressing and difficult to treat symptoms. The~     pilot study may provide evidence that a larger trial is needed to confirm the study results,~     or evidence that additional study in symptomatic patients and treatment comparison trials~     should be pursued.~   "
64649|NCT02211105|"~     The purpose of this prospective observational research study registry is to examine whether~     two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless~     Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side~     effects and post-procedure costs associated with episodes of care and any ensuing~     complications.~   "
64650|NCT02211092|"~     The purpose of this study is to develop an individually tailored home-based physical~     activity intervention for family caregivers of people with advanced cancer and assess the~     feasibility of a future randomized controlled trial (RCT) to test the effects of this~     intervention.~   "
64651|NCT02211079|"~     The purpose of this study is to assess the effects of single and multiple once daily doses~     of 50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug~     enters and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide~     in healthy male participants.~   "
64652|NCT02211066|"~     The study is a single-centre, randomized, active controlled, open label clinical trial. The~     primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately~     after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)~   "
64653|NCT02211053|"~     The purpose of this study is to evaluate if the administration of an infusion of~     levothyroxine can improve heart function in organ donors~   "
64654|NCT02211040|"~     The investigators have developed an eHealth intervention based on self-regulation for the~     promotion of self-regulation of physical activity and fruit and vegetable intake among~     adults who visit general practice. Effectiveness of the intervention will be evaluated in a~     three-arm clustered quasi-experimental design in general practice.~   "
64655|NCT02211027|"~     Hypothesis The incidence of toxicity in patients receiving the tumor DNA-transfected~     fibroblast vaccine will be acceptably low and the immunologic response rate sufficiently~     high to warrant further study of this therapy~      The study of the vaccine will proceed in two stages after the method of Simon (102). In the~     first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic~     responses occur, the study will be terminated. If 3 or more responses are observed, the~     study will proceed to the second stage, accruing an additional 22 patients. If the second~     stage is complete and a total of 9 or more immunologic responses are observed among the 37~     patients treated, the treatment response rate for the vaccine will be considered high enough~     to warrant further study. Conversely, if the evaluation of the vaccine concludes at the~     first stage, or if 8 or fewer total immunologic responses occur after completing the second~     stage, the vaccine will not be considered for further study.~   "
64656|NCT02211014|"~     To characterize the safety profile of acalabrutinib with and without dexamethasone in~     subjects with relapsed or refractory Multiple Myeloma (MM)~   "
64657|NCT02211001|"~     The purpose of this study is to evaluate and compare the effects of three Exercise Movement~     Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises~     (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility~     of the posterior muscle chain.~   "
64658|NCT02210988|"~     The investigators design a randomized, single blinded, control study to evaluate the~     therapeutic effect of acupuncture in acute ischemic stroke patients:~   "
64659|NCT02210975|"~     Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure~     for morbid obesity due to its technical simplicity, low-morbidity and excellent results both~     for weight loss and control of metabolic syndrome. There are however reports of SG worsening~     pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing~     GERD have been denied the benefits of SG. In addition, patients that develop post-op GERD~     cannot undergo traditional anti-reflux surgery since the gastric fundus that is required for~     fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately~     controlled with medication can only opt for the more invasive gastric bypass procedure as~     their only surgical treatment option.~      In a recently reported case study, an obese patient with severe GERD successfully treated~     with EndoStim underwent SG and maintained adequate GERD control with continued use of LES~     stimulation therapy. However electrical stimulation was not yet tested systematically in~     patients with prior gastric operation such as sleeve gastrectomy.~      This study will test the hypothesis that electrical stimulation is effective in control of~     GERD associated with SG.~   "
64675|NCT02210767|"~     This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD~     risk factors, including central blood pressure, arterial stiffness indices, inflammatory~     markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and~     lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using~     the 16S rRNA gene.~   "
72313|NCT02110849|"~     To prospectively collect data from patients treated with proton therapy for prostate cancer~     using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment~     technique.~   "
64662|NCT02210936|"~     Brandeis University and University of South Carolina (USC) have joined together to develop~     the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic~     detailing (medical education) intervention for physicians and evaluate its effectiveness in~     a pilot study. The goal of the intervention is to increase the use of safe prescribing and~     prescription monitoring practices among primary care physicians. The research team will~     design and pilot an educational intervention for physicians who treat military personnel,~     veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to~     prevent the onset or progression of prescription drug problems among Iraq and Afghanistan~     veterans, military members, and their families who are at high risk for developing problems~     if their treatment involves long-term use of an opioid.~   "
64663|NCT02210923|"~     Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall~     in blood pressure in patients with resistant hypertension. Since the activation electrodes~     are implanted at the level of the carotid sinus, it is conceivable that the nearby located~     carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid~     chemoreceptors not only raises respiration, but it also increases sympathetic activity which~     may in part counteract the effects of BAT. The aim of the present study is to investigate~     whether there is evidence for concomitant carotid chemoreflex activation during BAT. We~     hypothesized that there is no clinically relevant co-activation of the carotid body~     chemoreceptors during BAT in patients with resistant hypertension.~   "
64664|NCT02210910|"~     This is a post-marketing study to further assess the safety and effectiveness of the~     InSpace™ in the study population in comparison to surgical RCT repair.~   "
64665|NCT02210897|"~     Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial~     infarction. Whereas the diagnosis is based on an increase and/or decrease in the~     concentrations of cardiac troponins with at least one value above the 99th percentile value~     of the reference population together with the evidence of ischemia, serial sampling is~     needed. Knowledge of the variation in cardiac troponin levels over time in individuals in a~     normal rest state (not during an acute myocardial infarction), also called the biological~     variation, is important regarding the interpretation of the serial cardiac troponin levels.~     A recent study by our group showed a circadian rhythm in cardiac troponin levels. This~     circadian rhythm is important regarding the interpretation of the serial cardiac troponin~     levels.~      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The~     mechanism of the elevated concentration of cTn in these subjects is still unclear. It is~     hypothesized that impaired renal clearance contributes to elevated levels of cTn. However,~     it is not clear whether renal function affects the biological variation and circadian rhythm~     of cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects~     with impaired renal function creates the opportunity to assess the effect of renal clearance~     on the circadian rhythm of cardiac troponins.~   "
64666|NCT02210884|"~     Synthesis of vitamin D in the skin through the action of sunlight is a major source of~     vitamin D in parts of the world where foods are not fortified with the vitamin. Skin~     pigmentation (color), dress habits and season are some of the factors that limit sun~     exposure and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially~     important to meet infant needs when newborns are not supplemented with vitamin D. In~     Ethiopia, vitamin D status of lactating women and infants and breast milk vitamin D~     concentration have never been assessed. The purpose of this study is to assess changes in~     maternal and infant markers of vitamin D status before and after vitamin D supplementation~     of the lactating mothers.~   "
64667|NCT02210871|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after~     a single injection of semaglutide in subjects with mild, moderate or severe hepatic~     impairment compared to subjects with normal hepatic function.~   "
64668|NCT02210858|"~     This phase I/II trial studies the side effects and how well tipifarnib works in treating~     patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated~     myeloproliferative disorders. Tipifarnib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
64669|NCT02210845|"~     The objective of this study is to investigate whether a behavioral modification intervention~     in the form of either a 6-month supervised training program or a 6-month financial incentive~     weight loss program, results in improvement of diabetes outcome such as overall sugar~     control and lipid control.~   "
64670|NCT02210832|"~     Investigators will examine whether adding financial incentives to current best practices for~     smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a~     telephone quit line) increases cessation rates and improves infant health. While more~     expensive upfront compared to best practices alone, the investigators hypothesize that this~     treatment approach will be economically justified by the later cost savings associated with~     more women quitting, having healthier babies, and needing less healthcare. It should also~     help to reduce the greater risk for health problems often seen among those who less well off~     economically.~   "
64671|NCT02210819|"~     Following the findings of the clinical trials in drug development, this global~     non-interventional cohort field study will investigate rivaroxaban under clinical practice~     conditions in comparison with current standard of care for patients with acute venous~     thoromboembolism (VTE).~      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of~     acute VTE in routine clinical practice.~   "
64672|NCT02210806|"~     This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol~     dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a~     DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.~   "
64673|NCT02210793|"~     The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser~     vision correction using no-touch all-laser photorefractive keratectomy in comparison to~     conventional lasik~   "
64674|NCT02210780|"~     This is a 32-week, randomized, double-blind, placebo-controlled, parallel-group study~     assessing immunization responses to vaccination in adults with moderate to severe atopic~     dermatitis who are treated with subcutaneous dupilumab.~   "
72322|NCT02110732|"~     The purpose of this study is to evaluate the effect of oral administration of probiotic~     Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.~   "
64676|NCT02210754|"~     This trial was the initial characterization of the blu™ products being studied, with the~     purpose of gaining an understanding of the exposure to nicotine and craving reduction~     attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were~     utilized: a single controlled administration and a short-term ad lib use. As smoking~     behaviors vary from smoker to smoker, a controlled administration allows for some~     standardization of nicotine dose for each of the study products to better understand their~     uptake characteristics as well as urge reduction achieved under controlled conditions.~     Further evaluation under ad lib product use conditions provides insight into product~     self-administration behaviors that will allow subjects to achieve acceptable levels of urge~     reduction. Comparisons were made to evaluate differences between blu™ formulations as well~     as to the market-leading conventional cigarette, Marlboro Gold King Size (Marlboro~     cigarette').~   "
64677|NCT02210741|"~     Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The~     prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of~     genetic predisposition. Despite its clinical and scientific significance, Graves' disease is~     still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The~     immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both~     a snapshot and a historical record of a person's immune function. Thanks to the power of~     next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell~     receptors suddenly becomes plausible, and opens a door for many creative approaches to study~     immune related diseases. The ultimate goal of this project is to use both the NGS deep~     sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic~     fine mapping, and to identify Graves' disease-specific T cell and B cell receptors.~     Furthermore, using the immune repertoire approach, investigators want to study the critical~     epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various~     disease stages and in various sub-groups. Investigators expect to solve the immune~     repertoire of Graves' disease of different sub-group presentations and at various disease~     activity stages.~   "
64678|NCT02210728|"~     The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT)~     for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant~     medication and compare it to medication alone. Subjects will be randomly assigned to~     stimulant medication only, CBT only and combined CBT and stimulant medication group.~     Patients will be evaluated at baseline, following mediation optimization (for medicated~     groups), following 12 months of treatment, after 3 months of follow up, and after 6 months~     of follow up. The investigators hypothesize that the combined group will have the best~     outcome at all evaluation points. ADHD in adults is associated with significant morbidity~     and impaired academic, occupational, social, and emotional functioning. Developing optimal~     treatment approaches for this population is key in improving their functioning.~   "
64679|NCT02210715|"~     People infected with HIV are living longer thanks to the use of antiretroviral therapy~     (cART). In aging HIV persons, other factors are associated with early death. One of the~     major factors is liver disease, which can be due to liver infections or reasons such as~     fatty liver. Fatty liver in the general population is a serious problem, affecting 30% of~     Canadian population. A specific type of fatty liver characterized by much inflammation,~     named nonalcoholic steatohepatitis (NASH) can lead to cirrhosis and death. Persons living~     with HIV can be at increased risk of NASH because of toxic effect of certain types of cART~     on the liver, obesity and other metabolic factors (for example diabetes). Some scientific~     data suggest that newer cART are associated with less fatty liver and liver damage. However,~     NASH has not been studied in detail in persons living with HIV. One reason for the lack of~     research is one of the only ways to detect liver disease is to undergo liver biopsy which~     can be painful and has complications. Recently, a new non-invasive technology (Fibroscan)~     has been developed which can tell doctors how much a liver is damaged and how much fat it~     contains without pain or complications. Moreover, a simple test measuring a specific protein~     in the blood, the cytokeratin 18 (CK-18), can help the diagnosis of NASH. We will study the~     effect of switching cART to newer types of HIV medication in patients with a non-invasive~     diagnosis of NASH done by Fibroscan and cytokeratin 18. We expect that switching older cART~     to less hepatotoxic drugs will lead to improvement of liver damage, fatty liver and NASH~     diagnosed by Fibroscan and cytokeratin 18. To evaluate this approach we plan to recruit 58~     consenting HIV mono infected patients with non-invasive diagnosis of NASH and/or fatty liver~     with liver damage. Participants will undergo Fibroscan, a blood test for cytokeratin 18, a~     complete physical examination and laboratory tests every 3 months for 12 months, then at 18~     and 24 months. The effect of the switching of HIV medications will be recorded. We~     anticipate that the current study will provide evidence for reduction of inflammation and~     liver damage with newer cART for treatment of HIV infection.~   "
64680|NCT02210702|"~     This is a prospective, randomized, controlled cohort study. This study will look at the~     effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20~     mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when~     compared to a control group using no hormonal contraception. Depressive symptoms and sexual~     function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona~     Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W).~     Participants will begin taking the medication at Week 3 postpartum, and these outcomes will~     be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators~     hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and~     BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and~     increase in sexual function in both of the oral contraceptive groups.~   "
64681|NCT02210689|"~     A multi-center, double-blind, randomized, placebo controlled, parallel-group study,~     comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse®~     (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo~     control in the treatment of bacterial vaginosis in non-pregnant women.~   "
64682|NCT02210676|"~     Aim:~      The purpose of the study is to learn more about how a person recovers after treatment for~     mallet finger injury. The investigators want to identify the best outcome after mallet~     finger injury and how to improve treatment strategies.~      Primary null hypothesis:~      There are no statistically significant factors associated with extensor lag between 4 weeks~     and 4 months after immobilization is discontinued for a mallet finger among demographic,~     injury, and treatment factors.~      Secondary null hypothesis:~      There are no statistically significant factors associated with PROMIS upper extremity~     function between 4 weeks and 4 months after completion of immobilization for a mallet finger~     among demographic, psychological, injury, and treatment factors.~   "
64683|NCT02210663|"~     This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and~     preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid~     tumors.~   "
64711|NCT02210286|"~     The purpose of this study is to examine the effects of supplementing Magnesium L-Threonate~     in people with mild to moderate dementia . The investigators goal is to understand whether~     Magnesium L-Threonate will be associated with improvement in memory and brain function.~   "
64684|NCT02210650|"~     Patients with a ureteral (the tube that leads from the kidney to the bladder) stone often~     also have small stones in the kidney (frequently visible on CT). If these small kidney~     stones are determined to be asymptomatic (not causing any problems or pain), then most~     urologists will simply remove the symptomatic ureteral stone and leave the additional stones~     in the kidney above. However, the investigators know that the ureteral stone started in the~     kidney. This means that the small stones remaining in the patient's kidney may cause~     problems later. The purpose of our research is to test if removing small stones from the~     kidney prevents future stone episodes~   "
64685|NCT02210637|"~     To evaluate the association of non attendance at scheduled appointments with visits in the~     emergency department, hospitalizations and mortality during one year follow up.~   "
64686|NCT02210624|"~     The purpose of study is to evaluate the safety and efficacy of autologous bone~     marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem~     cell therapy is an emerging alternative treatment modality in incurable and intractable~     neurological disorders. This pilot study aims to evaluate the feasibility and safety of stem~     cells in anaerobic brain injury.~   "
64687|NCT02210611|"~     The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved~     with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination~     than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH~     antagonists.~   "
64688|NCT02210598|"~     This study represents the first randomized trial comparing traditional inpatient induction~     with a transcervical foley catheter versus outpatient induction with immediate removal of a~     transcervical foley catheter. The immediate removal technique allows the induction process~     to begin in the hospital setting, but allows the patient to go home without a foreign body~     in situ. The investigators hypothesize the outpatient group will spend less time~     hospitalized prior to discharge. Additionally, the investigators will explore the vaginal~     delivery rates and maternal/neonatal safety profiles between groups.~   "
64689|NCT02210585|"~     The study was designed to test the following hypotheses:~      Main Objective:~      To compare the level of spontaneous physical activity at 3 months after re-entrainment by~     multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to~     conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation)~     (control arm).~      Secondary Objectives:~      To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical~     activity, quality of life and quality of sleep, at 3 months and at 2 years in the two~     groups.~      Design:~      We will conduct a multicenter controlled study vs. reference care with randomization into~     two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES~     material available at home and will be supervised by monthly visits over 3 months and by~     telephone follow-up for two years. The study size calculation is based on physical activity,~     the percentage of lean body mass and arterial stiffness measured in the OBEX study.~      This project will determine whether the training strategy is effective for increasing~     physical activity and/or in inducing significant metabolic and cardiovascular effects in~     these patients after 2 years. In addition, it provides a solid base of investigation for the~     study of the interactions between muscle contraction and cardio-metabolic health with~     greater precision.~   "
64690|NCT02210572|"~     It has been shown that patients complaining of gas-related symptoms significantly improve on~     a diet low in fermentable residues. However, other studies suggest that some non-absorbable,~     fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce~     beneficial effects to the host, including improvement of abdominal symptoms. The aim of the~     study is to compare the effects of a diet low in fermentable residues versus a diet~     suplemented with prebiotics on intestinal microbiota composition, microbiota activity~     (intestinal gas production) and digestive symptoms.~   "
64691|NCT02210559|"~     This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019~     administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced,~     unresectable pancreatic cancer.~   "
64692|NCT02210546|"~     A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of~     sensitivity, specificity, and predictive value, in the screening of women at intermediate~     risk of breast cancer.~      Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio~     to:~        1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or~        2. Yearly MRI.~   "
64693|NCT02210520|"~     The low level laser therapy has a better effect in decrease the pain than ultrasound~     therapeutic.~   "
64694|NCT02210507|"~     The goal of the research study is to determine the absorption, metabolism, and bioconversion~     of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava~     compared to a mixture of red palm oil and gari made from typical white cassava.~   "
64695|NCT02210494|"~     Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for~     early adenocarcinoma of the esophagus.~   "
64696|NCT02210481|"~     Comparison between intravitreous glucose rate and macular thinning measured by Ocular~     Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular~     membrane. Hypothesis : Association between post-operative macular thickness and~     intravitreous glucose rate~   "
64697|NCT02210468|"~     The mechanism of Osteoarthritis (OA) is complex, however the investigators know that~     cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes,~     leading to proteases that break down cartilage. There is a protein in the human blood called~     alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage.~     Cytonics developed a device that use the patient's own blood to remove all cells and~     concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.~   "
64698|NCT02210455|"~     Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in~     children, and is the leading cause of mental disability in Canada. The term fetal alcohol~     spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic~     effects induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live~     births in North America, and it is estimated that FASD may occur as frequently as 1 in 100~     live births, making this a public health problem of epidemic proportion. Even though~     considerable efforts have been aimed at identifying children with FASD, the need for access~     to services and supports for Canadian families affected by FASD remains unfulfilled.~     Additionally, there is little empirical data available to influence policy change in how~     these services and supports are delivered.~      A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol~     Spectrum Disorder (FASD): A Framework for Action document was the need to determine the~     types of supports children with FASD and their families require and to develop appropriate~     mechanisms to provide these services at the community, provincial/territorial and federal~     levels. This identified need forms the basis of the current proposal.~      Although a variety of psychosocial interventions have been developed to treat~     neurobehavioural disorders, relatively little research has been conducted that is~     specifically aimed at improving the behavioral challenges identified in children with FASD.~     Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be~     developed using input from major stakeholders to meet the current limitations in access for~     families seeking services and supports; and (ii) this intervention and its evaluation will~     provide evidence for feasibility and efficacy to support changes in policy by key~     decision-makers and provide the basis for developing promising practices in the area of~     interventions for families affected by FASD. This grant will link academic teams with~     parents/guardians and decision makers to develop and evaluate a training program for the~     parents/guardians of children with FASD.~      Participants will be recruited from across Canada. The specific objectives of the proposed~     research program, which will be addressed in three inter-related studies, are to:~        1. Develop an Internet-based intervention program for parents/guardians of children with~          FASD between the ages of 4-12 years, that is based on information collected from~          interviews completed by major stakeholders (e.g., parents/guardians, clinicians,~          decision-makers, community-based organizations);~        2. Evaluate the feasibility (usability) of the intervention; and~        3. Obtain data on outcomes from the randomized controlled trial This research will adopt~          an integrated knowledge translation and exchange approach where knowledge production,~          dissemination, uptake and usage will occur seamlessly throughout the project and~          researchers and knowledge users are engaged in the project right from its inception.~      The intervention will be based on the Strongest Families program that is designed to help~     families learn to deal with common childhood problems in the comfort and privacy of their~     home, and provide treatment and care via telephone contact with trained coaches, written~     manuals, videotapes, and audiotapes. This program has been successful in children~     neurodevelopmental disorders; and will be adapted for use in the FASD population, as~     children with FASD, share many of the same behavioral characteristics.~   "
64699|NCT02210442|"~     A multicenter study to evaluate the effectiveness of a teaching strategy based on the~     incorporation of educational games with simulated settings versus usual practice based on~     diffusion for the implementation of clinical practice guidelines in Family Medicine~     Residency Program. The impact of the new strategy will be measured in improving knowledge~     and skill acquisition in clinical decision making of Family Medicine Residency Program after~     6 months. Effectiveness will also be measured a month and 12 months after intervention.~   "
64700|NCT02210429|"~     We hypothesize that patients who receive a supraclavicular block via Angiocath, placed~     intra-operatively and dosed post-operatively following neurologic examination, will have~     lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care~     unit, and lower rates of intervention for post-operative nausea and vomiting. We also~     hypothesize that patients receiving this nerve block had the same rates of nerve damage as~     the patients who did not receive a block and that there will be no demonstrable safety~     concerns with this block.~   "
64701|NCT02210416|"~     Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of~     short-term advantages compared to open hernioplasties with mesh. In the prevailing economic~     climate, the total costs of treatment is a subject of intense research. This study is~     designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a~     special emphasis in costs of treatment, complications and convalescence.~   "
64702|NCT02210403|"~     The purpose of this study is to determine whether tDCS in combination with motor training~     can improve hand and arm function in stroke patients.~   "
64703|NCT02210390|"~     Aim:~      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological~     intervention for Bipolar disorder in Pakistan~      Design:~      Randomized Control Trial~      Setting:~      Psychiatric Departments of different Hospitals in Karachi.~      Participants:~      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and~     treatment as usual arm.~      Intervention:~      Culturally Adapted psychological intervention for bipolar disorder~      Outcome measure:~        -  Acceptance of intervention in terms of attending session and dropouts~        -  Knowledge and attitudes towards bipolar disorder~   "
64704|NCT02210377|"~     Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may~     contribute to cardiovascular events and high mortality. The etiology of IDH is~     multifactorial; therefore, it remains a challenging problem in the management of HD~     patients. Because moxibustion (MO) at specific points can influences hemodynamics, we~     hypothesize that Tianjiu (auto-MO) at the traditionally used meridian points will reduce the~     severity of hypotension in patients who undergo HD.~   "
64705|NCT02210364|"~     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin~     (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast~     Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the~     recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the~     safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the~     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity~     of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.~   "
64706|NCT02210351|"~     The asses and evaluate whether trans apical access for TAVR is associated with apical~     dysfunction.~   "
64707|NCT02210338|"~     The study aims to determine the better device to facilitate intubation in patients with a~     limited neck movement and small mouth opening. This may help anesthesiology as well as~     emergency medicine practitioners and departments to decide when choosing between these two~     conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior~     when compared to the Bonfils Intubation Fibrescope in success of intubation, time to~     intubation and complication rate in patients with a fixed cervical collar.~   "
64708|NCT02210325|"~     This study will compare a single dose of oral solithromycin to the standard of care~     (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with~     urogenital gonorrhea. A completed open-label Phase 2 study with single doses of~     solithromycin resulted in 100% microbiological eradication in male and female patients with~     uncomplicated urogenital gonorrhea.~   "
64709|NCT02210312|"~     Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions~     such as attention, perception, concentration, learning, abstract thinking and problem~     solving are impaired postoperatively. These changes can be resolved after weeks and months.~     In some cases, changes are permanent.~      The aetiology is multifactorial. One described risk factor is preoperative existing~     depressive symptoms in patients undergoing cardiac surgery.~      A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study.~     Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive~     function will be tested and compared to tests done before surgery. Postoperatively - from~     the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs~     of delirium, pain, cardiac, respiratory, renal and infectious complications will be~     monitored.~      Next to preoperative depressive symptoms we will also evaluate a diagnosed depression,~     anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical~     insufficiency, type of anaesthesia, intraoperative blood loss, organ complications,~     postoperative delirium, baseline cognitive functioning and the number of~     operations/anaesthetics in the study period after the initial operation as further potential~     predictors of POCD.~      In addition, laboratory values and certain medications will be documented. These include:~     anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea,~     glomerular filtration rate and cortisone therapy.~   "
64710|NCT02210299|"~     People are, especially in industrialized countries, exposed to a growing number of~     ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation,~     soil and dust dermal contact…), notably for semi-volatile organic compounds. Diet is~     generally sought to contribute the most to total exposure for many chemicals, the relative~     contribution of each pathway is nevertheless poorly described, and can be different among~     populations. This is in particularly the case For young children, who can be more exposed~     via the environment, because of frequent contact with object and dust and hand to mouth~     behaviors. Children are in addition considered more sensitive to chemical risk due to their~     maturating systems.~      In this context, the objective of this project is to characterize the young children's~     exposure to a particular class of semi volatile organic compounds. It will encompass the~     relative contribution of different pathways to the external dose, and to try to match the~     internal and external doses with a physiologically based pharmacokinetic (PBPK) model for~     molecules for which it is possible.~      The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated~     Substances (PFAS), used in numerous consumer products.~   "
64712|NCT02210273|"~     The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe~     and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.~   "
64713|NCT02210260|"~     Limiting surgical stress and managing postoperative pain are well understood to influence~     recovery and outcome from major surgery for colorectal cancer and both are fundamental~     aspects of enhanced recovery protocols.~      Traditional approaches for dealing with these problems such as epidural or patient~     controlled intravenous opioid analgesia are associated with problems that may be detrimental~     to postoperative recovery and surgical outcome. As a result there is evidence in the~     literature of increasing interest in alternative techniques such as intrathecal anaesthesia~     or continuous wound infusion of local anaesthetic, however nobody has examined the effect of~     combining the techniques or their impact on the surgical stress response.~      We intend to compare patients undergoing major resections for colorectal cancer receiving~     intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those~     receiving a continuous wound infusion alone. We will examine the surgical stress response~     and postoperative pain control in addition to objective measures of postoperative recovery.~      We suggest that our approach will attenuate the surgical stress response and provide optimal~     pain control that will ultimately translate in improved recovery and outcome following~     surgery for colorectal cancer.~   "
64714|NCT02210247|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL~     via local subcutaneous infiltration in healthy volunteers.~   "
64715|NCT02210234|"~     The purpose of this research was to understand the effects of bioactive compounds found in~     wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole~     wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function~     assays were performed at both sampling times. It was predicted that eating wheat bran would~     benefit immune function.~   "
64716|NCT02210221|"~     The research aims of the CENTER-TBI study are to:~        1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a~          European context, and~        2. identify the most effective clinical interventions for managing TBI.~      Specific aims~        1. To collect high quality clinical and epidemiological data with repositories for~          neuro-imaging, DNA, and serum from patients with TBI.~        2. To refine and improve outcome assessment and develop health utility indices for TBI.~        3. To develop multidimensional approaches to characterisation and prediction of TBI.~        4. To define patient profiles which predict efficacy of specific interventions (Precision~          Medicine).~        5. To develop performance indicators for quality assurance and quality improvement in TBI~          care.~        6. To validate the common data elements (CDEs) for broader use in international settings,~          and to develop a user-friendly web based data entry instrument and case report form~          builder.~        7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury~          Research (FITBIR).~        8. To intensify networking activities and international collaborations in TBI.~        9. To disseminate study results and management recommendations for TBI to health care~          professionals, policy makers and consumers, aiming to improve health care for TBI at~          individual and population levels.~       10. To develop a knowledge commons for TBI, integrating CENTER-TBI outputs into~          systematic reviews.~   "
64717|NCT02210208|"~     An open, non controlled, multi-centre, clinical investigation to verify performance and~     safety of a soft silicone wound contact layer containing silver in the treatment of skin~     grafts in surgical burn patients and the usefulness of a marketed donor site dressing.~   "
64718|NCT02210195|"~     The primary aim of the supplemental study is to provide POC testing of aprepitant as a~     treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in~     the parent grant will likewise be applied to the supplemental project to test for effects of~     aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The~     primary hypothesis is that subjects treated with aprepitant will have significantly less~     alcohol and marijuana use than subjects treated with placebo.~   "
64719|NCT02210182|"~     The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety~     and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects~     Undergoing Thermal Ablation~   "
64720|NCT02210169|"~     Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will~     be recruited. They will be randomised to receive vancomycin as an intermittent infusion~     (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that~     administering vancomycin as a continuous infusion will result in improved attainment of~     target concentrations in blood at steady state (when the drug is in equilibrium) compared to~     intermittent infusion.~   "
64721|NCT02210156|"~     The purpose of this study is to determine whether the consumption of a nutritional~     supplement with micronutrients and herbal extracts has an effect on the incidence of acute~     respiratory infections in susceptible adults.~      Our hypothesis is that subjects who consume the nutritional supplement will have a lower~     incidence and duration of acute respiratory infections in comparison with the placebo group.~   "
64722|NCT02210143|"~     The aim of this study was to evaluate the reliability of the avascular root surface area as~     a prognostic identification criterion for gingival recessions and to compare the predictive~     value of the Miller classification and avascular root surface area (AERSA) calculation on~     the final root coverage outcomes.~   "
64745|NCT02209844|"~     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847~   "
64746|NCT02209831|"~     Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.~      Safety and tolerability were also assessed.~   "
64747|NCT02209818|"~     The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain~     management in people commencing orthodontic treatment. The study design is a randomized~     controlled trial.~      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,~     and the other side will be treated by a placebo procedure. Pain assessment will be measured~     using Visual Analog Scales (VAS).~      The hypothesis of this study is that laser irradiation decreases the amount of pain~     following the insertion of orthodontic separators.~   "
64748|NCT02209805|"~     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as~     multiple daily doses at various dose levels.~   "
64749|NCT02209792|"~     The primary objective of this extension study was to obtain long-term safety data for BIRB~     796 BS in patients with moderate to severe Crohn's disease after 26 weeks of treatment.~     Secondary objectives were the evaluation of efficacy of BIRB 796 BS to induce clinical~     remission and response over 26 weeks of treatment.~   "
64723|NCT02210130|"~     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability~     in the general population, secondary to the accumulation of asymptomatic elementary lesions.~     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be~     challenging in term of public health care in the future. While HIV patients share the same~     cardiovascular risk factors and they are often diagnosed with cognitive impairment and~     frailty, CSVD has not been yet described in this population.~      The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating~     the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with~     the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular~     disease.~      HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough~     vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the~     macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic~     examination and specific kidney explorations to evaluate the micro-vascular disease of this~     two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same~     work-up.~      We are expecting to show the relationship between CSVD and cardiovascular risk factors in~     order to propose specific prevention. We will correlate the CSVD with the neurologic and~     cognitive function as it is already proved in the general population. We will correlate the~     CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap~     screening tools for the CSVD in the HIV+ population.~   "
64724|NCT02210117|"~     Objectives:~      Primary Objective:~      Safety and tolerability of therapy with nivolumab vs. nivolumab + bevacizumab vs. nivolumab~     + ipilimumab in Metastatic Renal Cell Carcinoma (mRCC) in the context of presurgical or~     prebiopsy therapy.~      Secondary Objective:~      To study immunological changes in tumor tissues and peripheral blood in response to~     nivolumab vs. nivolumab + bevacizumab vs. nivolumab + ipilimumab in RCC therapy.~      To assess the efficacy of presurgical nivolumab vs. nivolumab + bevacizumab vs. nivolumab +~     ipilimumab therapy in RCC by evaluating objective response rate and progression free~     survival.~   "
64725|NCT02210104|"~     The goal of this clinical research study is to learn about the safety of giving CD4+T cells~     with ipilimumab and cyclophosphamide.~      CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,~     and they are designed to find cancer cells and may kill them.~   "
64726|NCT02210091|"~     The study purpose is:~        -  To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly~          prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.~        -  To compare pharmacokinetic (PK) parameters to ADVATE.~        -  To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes.~        -  To evaluate safety and immunogenicity.~   "
64727|NCT02210078|"~     The goal of this clinical research study is to learn about the safety of giving cytotoxic T~     lymphocytes (CTLs) to patients who have had a stem cell transplant. Researchers also want to~     learn if these cells can help to control CMV.~   "
64728|NCT02210065|"~     The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes~     (CTLs) can help control CMV when it reactivates (becomes active again) in patients who~     receive an allogeneic stem cell transplant. Researchers also want to learn about the safety~     of giving CTLs to patients who have had a stem cell transplant.~   "
64729|NCT02210052|"~     The goal of the study is to determine if patients undergoing radiofrequency neurotomy of~     lumbar facet joints that are adjacent to previously placed pedical screws from a fusion,~     will lead to an increase in the temperature of the pedical screws.~   "
64730|NCT02210039|"~     The study is being done to test the feasibility and tolerability of a SECM imaging probe in~     patients with Barrett's Esophagus (BE).~      A total of 12 subjects will undergo SECM probe imaging while they are under conscious~     sedation. Spiral SECM imaging will be performed continuously over a pre-determined length.~     Patients will later be asked for their feedback.~   "
64731|NCT02210026|"~     The investigators propose to test the hypothesis that Seattle bubble nasal continuous~     positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth~     weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway~     pressure.~   "
64732|NCT02210013|"~     The investigators want to carry out a prospective study of 400 infertile Caucasian and~     Indian women who will undergo a controlled ovarian stimulation for in vitro fertilization~     (IVF). The investigators will collect data about ovarian reserve markers and also the~     results after ovarian stimulation in both ethnic groups.The aim is to identify differences~     in ovarian response after IVF stimulation between both groups.~   "
64733|NCT02210000|"~     This study is a randomized, double-blind, placebo controlled trial designed to confirm the~     symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1~     and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to~     determine if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat~     administration improves gastroparesis symptoms as measured by the Gastrointestinal Cardinal~     Symptom Index - Daily Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2~     diabetes mellitus (DM) who have documented abnormally slow gastric emptying and have~     symptoms consistent with gastroparesis.~      Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study~     will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a~     2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety~     follow-up visit.~   "
64734|NCT02209987|"~     This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,~     characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after~     subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation~     of anti-GS-5745 antibodies after SC and IV administration.~   "
64735|NCT02209974|"~     Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic~     inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is~     controversial.~   "
64736|NCT02209961|"~     A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and~     glaucoma surgery.~   "
64737|NCT02209948|"~     The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles~     improve progression-free survival in patients with glioblastoma included in this study,~     randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and~     residual disease or not, to receive an additional 6 cycles of temozolomide.~   "
64738|NCT02209935|"~     Background. Early rehabilitation programs (ERP) that include physical, occupational, and~     speech therapies lessens debilitation and promotes return to previous physical and cognitive~     functioning and have been successfully applied in adult intensive care units (ICUs). Despite~     the fact that critically ill children with acute brain injury (ABI) are at increased risk of~     life-long disability and stunted development, benefits of ERP for this group have not been~     studied and are not standard of care in pediatric ICUs.~      Objectives. The aims of this study are 1) To better understand current practices and~     barriers to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in~     children with ABI in the ICU by randomizing children to these groups and measuring outcomes.~     We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP~     group will be superior compared to the usual care group.~      Methods. The first task of this research program is to survey healthcare professionals~     (physicians, nurses, allied health) and families of children in the ICU about their~     hospital's resources, current practices, and barriers to ERP. This survey will be~     distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis~     Investigators (PALISI), a group of clinicians and researchers dedicated to improving child~     outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized,~     controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by~     48 hours of ICU admission and those in the usual care group will begin therapies when these~     services are ordered by treating physicians. Children aged 3-17 years with ABI expected to~     be admitted to the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to~     the brain are eligible. Therapy interventions are individualized for the child's clinical~     status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale~     (VABS) pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's~     physical and cognitive function as well as behavior. Other tests will be performed that~     assesses child and family quality of life and length of hospital admission. Our outcome~     tests were chosen because 1) They are the most important outcomes to families of children as~     surveyed in our ICU and 2) They are outcomes that can be influenced by ERP.~      Summary. This is the first and largest study designed to evaluate whether ERP improves~     outcomes for critically ill children with ABI. We anticipate that rehabilitation practices~     in ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group~     will have superior adaptive and quality of life outcomes, outcomes important to families,~     without increasing adverse events compared to patients in the usual care group.~   "
64739|NCT02209922|"~     Purpose:~      The incidence of stroke in low-to-middle income countries is increasing .Balance impairment~     and falling negatively impact function of stroke patients. Mobility is based on successful~     postural control and about 30% of individuals with stroke are unable to ambulate without~     assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor~     recovery in neurological disease.This can be addressed through a tDCS intervention.~      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined~     with Biodex balance training on postural control in chronic stroke patients using laboratory~     and clinical assessments. The following essential treatment components; a) active tDCS~     stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance~     training program.~      To identify combinations effects of tDCS stimulation plus balance training . Hypothesis:~     Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will~     significantly improve stroke clients' balance and functional mobility.~      Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions~      Experimental: Arm 1~      tDCS brain stimulation and simultaneous balance training~      Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance~     training(20 minutes) for 5 consecutive days.~      No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance~     training~   "
64740|NCT02209909|"~     Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect~     thrombus formation. The purpose of this study is to assess the effects of preoperative~     continuation of aspirin on platelet activation after off pump coronary artery bypass~     surgery.~   "
64741|NCT02209896|"~     The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external~     components.~      The system is intended for home care use. The chronic pain treatment is achieved by an~     electrical stimulation of peripheral nerve fibers. The stimulation is set so that it~     generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and~     improving the quality of life for the patient.~   "
64742|NCT02209883|"~     COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen~     occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic~     used considerably widely all over the world. Because respiratory functions and gas exchange~     became impaired in COPD patients, the respiratory system excretion/washout of inhalational~     anesthetic agents can be affected. In our study we aimed to investigate if there is a~     relation between sevofluorane's washout time and the degree of COPD.~   "
64743|NCT02209870|"~     The quality of cardiopulmonary resuscitation (CPR) has been identified as an important~     determinants for patient survival, yet many studies revealed poor CPR guidelines compliance~     in real-life practice for both health care providers and lay persons. Common shortcomings~     identified include an insufficient number of chest compression, too rapid lung inflations,~     and too much hands-off time. The poor quality of CPR is associated with lower survival rate.~     Besides, some other problems could be found during resuscitation, such as prolonged~     intubation time, delayed first shock delivery or unsteady drug delivery interval. These~     problems can't be blamed on the only person but the teamwork. Certain measurements could~     improve the performance of the resuscitation team, such as audio prompt or checklist.~      Methods proposed and improvised to improve the quality of CPR have included CPR assisted~     devices, automatic driven devices or audio prompt system. However, some of these methods are~     hardly incorporate with the original resuscitation process since it could be an extra~     workload. Therefore, the investigators try to provide an digitized checklist combined with~     visual and audio alarming system, which could not only minimize the workload of chart~     recording but also remind the team to perform essential procedures in time.~      Information gained from a video-recording evaluation system had been employed to improve the~     resuscitation skills. The improvement of resuscitation quality also could be found through~     video-recording after certain intervention. It can also avoid the interference of the~     resuscitation and find out other harmful factors to CPR quality.~   "
64744|NCT02209857|"~     Rationale:~      Prediction of prognosis in patients with breast cancer is important to determine the~     indication for adjuvant chemo-, endocrine- and immunotherapy. Apart from the~     clinicopathological parameters incorporated into the Adjuvant!Online predictive model, the~     validated 70-gene signature MammaPrint® is predictive of outcome too. MammaPrint® is advised~     in the current Dutch CBO guideline (2012) for hormone receptor positive, invasive ductal~     breast cancer in individual cases when there is 'doubt' about the indication for adjuvant~     chemotherapy based on traditional prognostic factors. In the present study MammaPrint® is~     used in this CBO 2012 guideline defined group of patients as an additional test for~     decision-making for adjuvant chemotherapy.~      Objective:~      To assess the impact of MammaPrint® on clinical decision making regarding the administration~     of adjuvant chemotherapy in the CBO 2012 guideline defined group of hormone receptor~     positive invasive ductal carcinoma patients when there is doubt about the indication for~     adjuvant chemotherapy based on traditional prognostic factors. The influence of various~     factors and the impact of MammaPrint® in predefined subgroups will be analyzed too. Data~     from a national registry regarding adjuvant systemic treatment in patients with similar~     clinicopathological characteristics in whom MammaPrint® was not used will be obtained to~     provide a control group.~      Hypothesis:~      In the group of patients where national guidelines advocate using systemic therapy but~     doctors are ambivalent in treating patients with adjuvant chemotherapy, it is hypothesized~     that using MammaPrint® as an additional test will change the indication for adjuvant therapy~     in a substantial proportion of patients resulting in at least 10% less patients who receive~     adjuvant chemotherapy. Thus, in the study group at least 10% less patients will receive~     chemotherapy when compared to a contemporary group of patients with similar~     clinicopathological characteristics but without using MammaPrint®~      Study population:~      Hormone receptor positive, invasive ductal breast cancer patients when there is doubt about~     the indication for adjuvant chemotherapy based on traditional prognostic factors.~      Study design:~      This is a prospective multicentre impact study.~   "
64753|NCT02209740|"~     Renal outcome could be different after switching tenofovir to different antiretroviral~     strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance~     of renal evolution in these patients, in terms of grade and time to renal improvement,~     according to the different options after interrupting tenofovir. The aim of this study was~     to explore the renal outcome after tenofovir according to new antiretroviral regimen.~   "
64754|NCT02209727|"~     Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose~     administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.~   "
64755|NCT02209714|"~     The objective of the study is to obtain information about the safety and tolerability of~     BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose~     (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic~     data.~   "
64756|NCT02209701|"~     Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin~     and major metabolites in head and neck cancer and other cancer patients with solid tumors~     who receive radiation therapy.~   "
64757|NCT02209688|"~     The objective of this study was to obtain safety and tolerability data and first~     pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.~   "
64758|NCT02209675|"~     Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker~     for differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients~     post living donor liver transplantation (LDLT) .As each condition require different~     treatment~   "
64759|NCT02209662|"~     Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with~     physician-selected standard of care treatment such as debridement, hydrogel or saline~     irrigation, primary dressing, and offloading will be randomized into one of two groups, the~     Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce~     growth factors that can help in wound healing.~   "
64760|NCT02209649|"~     Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed~     dose combination tablets with the separate Telmisartan and Lacidipine tablets.~   "
64761|NCT02209636|"~     The proposed research is a randomized-controlled trial to determine the effectiveness of~     reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the~     function of arteries in adults with moderate to severe chronic kidney disease (CKD). [COMIRB~     13-0328] Additionally, it will determine phosphorus balance among adults with CKD and~     whether there is a difference in phosphorus balance after three months of treatment with~     lanthanum carbonate. [COMIRB 15-0384]~   "
64762|NCT02209623|"~     The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced~     Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0~     days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be~     verified by medical record review when possible. There will be an emphasis on enrolling~     women who have received Tdap before the current pregnancy, to the greatest extent possible.~     Non-pregnant women who are receiving their initial Tdap will also be recruited.~      Injection-site (local) and systemic reaction data will be assessed on the vaccination day~     and during the 7 days following vaccination using either identical web-based or paper~     diaries, depending on the preference of the study participant.~      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal~     outcomes obtained from review of the electronic medical record.~   "
64763|NCT02209610|"~     A hallmark of patients with heart failure (HF) is premature fatigue which impairs their~     quality of life and depicts a major source of morbidity. Premature fatigue may be attributed~     to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or~     b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e.~     central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force~     and power generating capacity and to a compromised ability to perform whole body activities~     (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers~     from the working muscle play a critical role in the development of both components of~     fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during~     exercise and thereby exaggerate the development of central fatigue. In contrast, muscle~     afferents optimize muscle O2 delivery through the precise regulation of circulation and~     ventilation during exercise and thereby attenuate the development of peripheral fatigue.~   "
64764|NCT02209597|"~     Determine bioequivalence between branded and generic bupropion extended release (XL)~     products (and between generic products) at steady state in patients with major depressive~     disorder.~   "
64765|NCT02209584|"~     This registry is intended to measure the impact of Prolaris® testing on therapeutic~     decisions when added to standard clinical-pathological parameters in men with newly~     diagnosed prostate cancer.~   "
64766|NCT02209571|"~     Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients~     with age and gender-matched healthy adults in order to identify a disease-specific exhaled~     breath pattern as well as to gain insight into pathophysiological and microbial~     contributions to exhaled breath composition.~   "
64778|NCT02209415|"~     Follow-up after successful operative treatment of cancer in the esophagus, stomach or~     pancreas in order to detect recurrent disease is a controversial topic.~      This is because the methods and the consequence of following these patients is unknown.~      Therefore the investigators will randomize these patients in to two groups:~        1. One group of patients will be offered visits with a specialist surgeon in a outpatient~          setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is~          the current standard at our department.~        2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same~          intervals as the first group.~   "
64814|NCT02208947|"~     The specific aims of the project are: 1) to test the effectiveness of consumer-directed~     financial incentives paired with provider-directed financial incentives, compared to~     provider-directed financial incentives alone, for increasing advance care planning (ACP)~     among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of~     consumer-directed financial incentives for ACP among study participants. The investigators~     hypothesize that consumer-directed financial incentives will result in a 15-percentage point~     absolute increase in the proportion of subjects completing ACP. The investigators do not~     advance hypotheses about the qualitative component.~   "
64767|NCT02209558|"~     Sternal precautions are standard patient education protocol disseminated to post-operative~     open heart surgery patients . While this best practice safety measure is widely~     distributed to patients, the origin of said precautions is unknown. Statewide hospitals vary~     on their parameters for sternal precautions using a myriad of restrictions, i.e. weighted~     activities, biomechanical movements to be avoided. In addition, the medium in which sternal~     precautions are taught varies, thus complicating patient adherence to these vital~     post-operative measures.~      The primary objective of this study is to use a randomized pre-post test design to compare~     two different training procedures. One training group examines current standard of care~     (providing verbal instruction using teach back and written sternal precautions). The second~     training group provides subjects with visual depiction of sternal precautions, in addition~     to standard of care. The study will analyze 30 and 60 day readmission rates for~     aforementioned patients. Finally, the study will assess changes in behavior intentions from~     before training to after training in both groups via behavioral analysis survey consisting~     of 8 questions.~      Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal~     precautions, in addition to standard of care, will have a lower 30 and 60 day readmission~     rate when compared to subjects in the standard of care group~      Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward~     sternal precautions will be greater from before training to after training in the visual SPs~     in addition to standard of care group than the standard of care only group.~   "
64768|NCT02209545|"~     The aim of this research work is to assess the impact of a single preoperative dose of~     buccal misoprostol in reducing blood loss during abdominal fibroid surgery.~   "
64769|NCT02209532|"~     This is a randomized, prospective, open label, multicenter study to assess the safety and~     utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of~     lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN~     mapping.~   "
64770|NCT02209519|"~     Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with~     metronidazole or placebo to compare the rates of recurrent BV in the women~   "
64771|NCT02209506|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.~   "
64772|NCT02209493|"~     In light of the high CVD morbidity and mortality, promoting simple interventions to improve~     serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases.~     Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)~     are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol~     control. However, the literature documenting their purported hypocholesterolemic potential~     is scarce. Given the unique composition and potential benefits of nopales, their use may be~     an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.~     Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with~     nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison~     to a control food with lower antioxidant and fiber content (cucumber) among adults with~     moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited~     data exists on the effects of nopales supplementation on other factors associated with~     cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity,~     inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL~     oxidizability and total antioxidant capacity) will also be conducted.~   "
64773|NCT02209480|"~     This study aimed to test the efficacy of five Alexander Technique lessons compared to the~     same period of heat pad application and guided imagery in patients with chronic non-specific~     neck pain.~   "
64774|NCT02209467|"~     The study hypothesis is that for people with moderate to severe multiple sclerosis postural~     balance and walking improve and the risk of accidental falls are reduced after participating~     in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain~     a further 7 weeks post training.~      Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and~     postural balance are often affected early in the course of the disease. The risk of falls is~     large. Many persons with MS have decreased trunk stability compared to healthy persons . In~     an earlier study including people with mild to moderate MS we found that a period of core~     stability exercises reduced the risk of falls. In this study the training concept will be~     applied for persons with more severe walking limitations.~   "
64775|NCT02209454|"~     The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an~     Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In~     addition, this study intends to evaluate the safety and tolerability of Test and Reference~     formulations.~   "
64776|NCT02209441|"~     -  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of~          sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as~          first-line treatment for advanced gastric cancer~        -  The design of the study incorporated a standard 3 + 3 dose escalation procedure to~          guide elevation of the sorafenib dosage to the next level~   "
64777|NCT02209428|"~     Low grade gliomas (LGGs) are the most common primary central nervous system malignancies.~     Brain surgeries with the most possible extent of resection are endeavored to achieve longer~     survivals in LGG patients. For patients with tumor located in eloquent areas so that gross~     total resection is not applicable, National Comprehensive Cancer Network (NCCN) 2013~     guidelines assigned both radiotherapy or chemotherapy as adjuvant treatments of low grade~     glioma following surgeries. Retrospective studies have suggested that temozolomide (an oral~     chemotherapeutics) chemotherapy have good effects on the control of tumor progression or~     recurrence in LGG patients after surgeries, especially in those with isocitrate~     dehydrogenase (IDH) gene mutations.~      Therefore, our prospective cohort study is to provide a higher level(IIb) of evidence for~     the correlation between IDH mutation and the responsiveness to up-front adjuvant metronomic~     temozolomide chemotherapy in young patients with LGG located in eloquent brain areas. And~     hopefully justify future RCTs with comparison between effects of adjuvant radiotherapy and~     chemotherapy in these patients.~   "
64790|NCT02209259|"~     The investigators plan a prospective randomized study to see whether negative questions~     affect measures of mood, pain, or disability. A total of 175 patients will participate at~     Massachusetts General Hospital.~   "
64779|NCT02209402|"~     Chronic kidney disease (CKD) is a prevalent disorder and a major health concern.~     Cardiovascular disease is the most prevailing and life-threatening complication observed in~     patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk~     level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are~     more likely to occur than the evolution to final stages of kidney disease with the need for~     dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not~     affect cardiovascular prognosis in CKD, which suggests that the missing link between these~     two entities has not been elucidated yet.~      In the present project, the investigators focus on endothelial dysfunction in patients with~     CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the~     absence of structural changes, endothelial dysfunction is still reversible, which offers~     therapeutic perspectives to tackle the progression towards atherosclerosis in an early~     stage.~      The purpose of this study is to determine whether an exercise training program is effective~     in ameliorating endothelial dysfunction in patients with chronic kidney disease.~   "
64780|NCT02209389|"~     The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in~     asymptomatic women for whom screening or diagnostic mammography findings are normal or~     benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS~     composition/density 3 or 4). The device is intended to increase breast cancer detection in~     the described patient population. Based upon the result of OctavaPink, the patient will be~     further evaluated by their physician.~   "
64781|NCT02209376|"~     An Open-Label Phase 1 Pilot Study to determine the safety and feasibility of CART-EGFRvIII~     (autologous T cells transduced with a lentiviral vector to express a chimeric antigen~     receptor specific for EGFRvIII) in the treatment of patients with EGFRvIII+ glioblastoma who~     have had their first recurrence as determined by standard imaging or have have residual~     disease after initial resection.~   "
64782|NCT02209363|"~     Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's~     disease (PD), often progresses to dementia, and profoundly affects quality of life.~     Obstructive sleep apnea (OSA) is a common disorder in the general population that is~     treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive~     function, but whether treatment improves cognitive function is less clear. When already~     affected by a degenerative process like PD, the brain might be more vulnerable to the~     effects of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized~     as a significant factor in PD. In preliminary work in PD patients, the investigators have~     found an association between OSA and poor cognition, and cognitive improvement with PAP~     therapy. The investigators now wish to more rigorously evaluate the effect of OSA treatment~     on cognitive function in PD in a randomized controlled trial. The investigators primary~     objective is to assess, in PD patients with OSA and cognitive deficit, the effect of OSA~     treatment on global cognitive function. The investigators will also assess other non-motor~     symptoms of PD, quality of life, and specific domains of neurocognitive function. PD~     patients will be recruited from the McGill Movement Disorders Clinic and other Quebec~     Parkinson Network Centres. Participants will need to have evidence of cognitive deficit and~     presence of OSA on screening diagnostic polysomnography (sleep study). Ninety subjects will~     be randomly assigned to PAP or nasal dilator strips. Detailed neuropsychological testing and~     other measurements (including quality of life) will be done at baseline, 3 months and 6~     months. At the end of the study period, subjects will have polysomnography on their~     respective treatment to assess efficacy with respect to OSA treatment. This study may~     demonstrate that a non-pharmacologic intervention has the potential to have a marked~     beneficial impact on cognitive function and quality of life in a significant proportion of~     PD patients.~   "
64783|NCT02209350|"~     The aim of the study is to compare effectiveness and long-term results of aorta-femoral~     reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC~     C,D).~   "
64784|NCT02209337|"~     A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety~     and performance of the SRS (Lyra Medical) vaginal mesh in POP patients~   "
64785|NCT02209324|"~     A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151~     in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes~     and Kaposi varicelliform).~   "
64786|NCT02209311|"~     Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in~     vitro.Tissue engineered construction will be created using synthetic tricalcium phosphate~     and autologous MMSCs. Patients will undergo sinus lift procedure with implantation of~     created tissue-engineered construction. This is a single arm study with no control. All~     patients receive cell therapy.~   "
64787|NCT02209298|"~     This observational study is intended to collect real-world (post-approval use) data~     regarding the clinical utility and performance of the Medtronic CoreValve® System for~     Transcatheter Aortic Valve Implantation (TAVI).~   "
64788|NCT02209285|"~     Patients with vascular and multiple chronic conditions (MCC) move between multiple care~     settings, and so they are at high risk of receiving fragmented care leading to increased~     risk for avoidable illness, death, and health care costs. Recent Canadian studies and~     reports identify significant gaps in the delivery of effective care to patients with~     multiple chronic conditions in community-based settings.~      The overall goal of the program is to promote successful management of chronic conditions,~     enhance quality of life, reduce the on-demand use of expensive health services and support~     primary caregivers (i.e. family or friends) who provide physical, emotional or financial~     care to an older adult with vascular conditions and MCC. This research program will leverage~     the tremendous potential to reduce the burden of vascular and vascular-related diseases by~     enhancing community-based prevention and chronic disease management.~      This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of~     an interprofessional intervention on health-related quality of life (HRQOL), depression,~     anxiety, physical functioning, and the costs of use of health services for stroke survivors~     with MCC receiving home care and their family caregivers. The results will inform: (1) the~     development of national standards for community-based care for patients with multiple~     chronic conditions and (2) the development of a new and innovative community-based model for~     the management of multiple chronic conditions that can be scaled up and spread across~     Canada.~   "
64789|NCT02209272|"~     Local anesthesia is commonly used to reduce pain during joint injections, particularly for~     deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most~     medical practices. It is well known that lidocaine infiltration itself is painful. Many~     strategies have been studied to minimize pain associated with lidocaine administration,~     including buffering, warming, and slowing infiltration rate. Bacteriostatic saline (BS) is~     an alternative local anesthetic that has been shown to be less painful when injected into~     subcutaneous tissues compared with lidocaine. However, BS use has not been widely~     implemented for local anesthesia, and it has not been studied in the context of joint~     injections. The purpose of this study is to compare infiltration pain and anesthetic~     efficacy between lidocaine and BS for ultrasound (US) guided intraarticular hip injections.~   "
64793|NCT02209220|"~     Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic~     obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic~     activation and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor~     for perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie~     de Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.~     Consequently, the identification and management of OSA in this high-risk surgical population~     is an essential part of practice. Actual guidelines recommend that treatment for OSA be~     initiated before the surgical procedure. Presently, the first line treatment for OSA is~     continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously~     to maintain the patency of the upper airways. However the compliance to this therapy is~     poor. An available alternative is automatic positive airway pressure (APAP) which delivers a~     variable amount of pressure to prevent reduction in airflow that accompanies upper airway~     obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse.~     APAP significantly reduces the mean level of pressure delivered in comparison to~     conventional treatment. Theoretically, it seems logical that applying the lowest pressure~     necessary would allow a better device-patient synchrony and therefore improve patient's~     comfort.Recent trials comparing APAP and CPAP have shown that APAP is non-inferior to CPAP~     in controlling obstructive events. APAP would be a valuable alternative if it was not for~     its excess cost. However, APAP improves compliance to treatment in two types of population:~     poor compliant subjects and those needing high pressure levels. The investigators know that~     compliance to positive pressure is poor in patients without excessive daytime sleepiness,~     which represents the majority of patient waiting bariatric surgery. Moreover, in patients~     needing levels of pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance,~     minimises side effects and improves quality of life. The review of 180 files of OSA patients~     treated by CPAP who had bariatric surgery in our center in 2012 demonstrated that the~     majority of patients needed high level pressure. These values suggest that APAP could~     improve treatment compliance in apneic patients waiting for bariatric surgery because they~     are usually poorly symptomatic and they generally require high positive pressure level.~   "
64794|NCT02209207|"~     This study will investigate the effects of interval walking training versus continuous~     walking training in patients with chronic obstructive pulmonary disease. Patients will be~     recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized~     to one of the two intervention groups. All walking training sessions will be performed on~     the same treadmill. Walking intensity in the continuous walking group will be 60 percent of~     the average speed of the 6-minute walking test. Patients in the interval training group will~     perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds~     alternating with 60 seconds of rest. The total exercise duration will be progressively~     increased from 10 to 32 minutes.~   "
64795|NCT02209194|"~     The purpose of the study is to evaluate the clinical and technical success as well as safety~     and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or~     bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with~     primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac~     implantation side.~   "
64796|NCT02209181|"~     To assess the safety and effectiveness one dose of a new pain reliever medicine~     (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or~     acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will~     evaluate pain relief effectiveness up to 6 hours after administration of the study drug.~   "
64797|NCT02209168|"~     The aim of this study is to confirm the difference in ovarian reserve markers and serum~     vitamine D levels between infertile indian, arabian and caucasian population.~   "
64798|NCT02209155|"~     This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate~     the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.~   "
64799|NCT02209142|"~     Depression is a leading cause of disability worldwide, affecting nearly 16% of the general~     population. Its physiopathology remains unclear. Based on gene-environment studies and~     epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)~     results from the convergence of multiple factors including biological factors such as~     multi-genic vulnerability, hormonal and immunological variations as well as environmental~     factors. As a consequence, mRNA could define a biological signature of the MDE.~   "
64800|NCT02209129|"~     Patients with a higher breast cancer risk (higher than 17% according to the IBIS~     calculation) will receive a 2D digital mammography together with a 3D tomosynthesis (so~     called combo tomo) of both breasts in two views in order to investigate the additional value~     of tomosynthesis in the diagnosis of breast cancer.~   "
64801|NCT02209116|"~     Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health~     disorders of childhood. Children with ADHD often have poor attention, are restless and~     hyperactive and show impulsive behaviour.~      It is important to detect ADHD so young people can have access to appropriate clinical~     interventions.~      One of the most common ways ADHD is assessed is through the clinician's opinion; however,~     this can vary between clinicians and is thought to be one reason why ADHD may be~     mis-diagnosed. Using a more objective computer tasks may help improve our understanding of~     ADHD. One computer task is the QbTest.~      The test presents different symbols to the child, and the child has to respond by pressing a~     button only when a target symbol appears. The test measures the child's attention,~     impulsivity and movement whilst doing this task.~      Although the test is thought to be a valid measure, more research needs to be conducted on~     this measure to see whether it helps clinicians decision making.~      To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication~     decisions, children and young people will be asked to complete the task as part of their~     initial assessment for ADHD. Half the participants and their clinician will have access to~     the QbTest result; the other half will not have access to the QbTest result until the end of~     the study.~      Participant's parents, teachers and the clinician will also be asked to complete some~     questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD~     and is given medication they will be asked to complete the task again on medication. The~     same set of questionnaires will be completed by the parents/teachers/clinicians.~      The entire sample will be followed up at 6 months and asked to complete the questionnaires.~   "
64802|NCT02209103|"~     This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation~     can improve objective sleep duration and/or quality, and/or improve perceived sleep quality~     and feelings of rest.~      Participants will complete a total of 9 test nights, which consist of sleeping with the~     sleep monitoring system after ingestion of the test product or a placebo, and filling out~     sleep-related questionnaires.~      The study has a crossover design, meaning that all participants receive all three~     interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a~     randomized order.~   "
64815|NCT02208934|"~     Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5~     mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers~   "
64803|NCT02209090|"~     Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions~     in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant~     women with epidural anaesthesia.~      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the~     Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,~     Spain.~      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be~     selected. Each woman will be assigned to a control or experimental group via an opaque~     envelope at a 1:1 ratio.~      The control group will deliver in free intrapartum positions, and the experimental group in~     a modified Sims position. Correction of foetal position is the key study variable, and~     delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20~     program.~   "
64804|NCT02209077|"~     This single-center, prospective, interventional clinical study is conducted to evaluate the~     repeatability and reproducibility of structural parameters of the optic nerve head, the~     peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT~     (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study~     are compared to those from a previous, larger healthy volunteer study that was conducted in~     the United States and Europe (S-2012-1), and data from glaucoma patients are compared to~     those from the healthy volunteers.~   "
64805|NCT02209064|"~     Prospective non-randomized, single arm trial to further evaluate the safety and performance~     of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial~     space during epicardial diagnostic or therapeutic (ablation) procedures.~   "
64806|NCT02209051|"~     The primary goal of the study is to demonstrate the increased rate of complete wound closure~     by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers~   "
64807|NCT02209038|"~     There is a large gap between the care seriously ill patients want and the care they receive.~     Advance directives (ADs) offer an opportunity for patients to express specific end-of-life~     preferences to avoid unwanted care. As promising as ADs may be for improving the quality of~     care near the end of life, rates of AD completion remain low and previous efforts to~     encourage their completion have had limited success. Principles of behavioral economics,~     such as the effects of defaults and other framing effects, may offer a novel approach to~     bridge the gap in end-of-life care. The goal of this study is to test whether the framing~     effect of expanding choice sets can increase the completion of and specification of choices~     within advance directives.~   "
64808|NCT02209025|"~     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein~     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk remains. An~     additive strategy to further lower this residual risk may be via raising high-density~     lipoprotein (HDL) concentrations, and in particular those of its major protein constituent~     apolipoprotein A-I (apoA-I). Based on several studies, theobromine may be a promising~     candidate in this respect. Recently, theobromine was shown to increase serum HDL cholesterol~     (HDL-C) concentrations by 0.16 mmol/L or 10% and apoA-I levels with 8%. The question is~     whether this increase in HDL-C and apoA-I concentrations observed translates into an~     improved functionality of the blood vessels. Effects of theobromine on vascular function~     have never been evaluated in a placebo controlled human intervention study.~      Objective: The primary objective is to evaluate the long-term effects of theobromine on~     vascular function in healthy subjects with a slightly lowered HDL-C in the fasting and the~     postprandial state. The second primary objective is to evaluate the long-term effects of~     theobromine on intestinal apoA-I mRNA and protein expression levels in healthy subjects with~     a slightly lowered HDL-C in the fasting and the postprandial state.~      Secondary objectives are to study the long-term effects of theobromine on (1) fasting serum~     HDL-C concentrations, (2) cholesterol efflux capacity and (3) postprandial lipid and glucose~     metabolism.~      Study design: A randomized, double-blind, placebo controlled cross-over design. The total~     study duration will be 12 weeks, consisting of a 4 week experimental period, a 4 week~     wash-out, and a 4 week control period. At the end of the experimental and control periods, a~     postprandial test will take place.~      Study population: Forty-eight healthy men aged 45-70 years and women aged 50-70 years, with~     slightly lowered HDL-C concentrations (men <1.3 mmol/L and women <1.5 mmol/L).~      Intervention: During the experimental period, subjects will consume daily at breakfast an~     drink containing 500 mg theobromine. During the placebo period, the subjects will consume~     daily at breakfast the same drink without theobromine. During the wash-out period, they will~     not consume any of the drinks.~      Main study parameters/endpoints: Measurements will be performed at the end of both 4-week~     intervention periods. The effects of theobromine will be calculated as the absolute~     differences between values obtained at the end of each period. The primary endpoint is the~     change in vascular function defined as % change in flow-mediated dilation (FMD) after intake~     of a daily stressor, a milkshake providing all the three different macronutrients. The~     second primary endpoint is the change in apoA-I mRNA and protein expression on the end of~     each period 5 hours after intake of the milkshake.~   "
64809|NCT02209012|"~     The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT~     in subjects with multiple actinic keratosis of the upper extremities who received treatment~     as part of the DUSA CP0108 study.~   "
64810|NCT02208999|"~     Assessing the long-term efficacy, complications, revision rates and final explantation of~     the device~   "
64811|NCT02208986|"~     The aim of this randomized single center study is to explore the most optimal dose of GnRHa~     used for triggering of final oocyte maturation in IVF. The study group will consist of~     oocyte donors who have GnRHa trigger as a standard trigger concept.~      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa~     will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality~     embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of~     the dose of GnRHa used for trigger.~   "
64812|NCT02208973|"~     To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg~     and 60mg) after repeated (8 days) single daily oral dose administration in young male and~     female healthy subjects.~   "
64813|NCT02208960|"~     Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million~     children under the age of 5, almost all in low- and middle-income countries, are not~     fulfilling their developmental potential. The development of the growing brain can be~     affected through multiple mechanisms including the same insults that are major causes of~     mortality, namely hypothermia and infection. The first month of life is a crucial period in~     neurodevelopment (ND). In this study, the investigators propose the home-based use of an~     integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal~     insults that may affect brain development, decrease neonatal mortality rate (NMR), and~     provide early identification of danger signs. The investigators hypothesize that use of the~     neonatal toolkit will result in an improvement of at least one standard deviation in~     neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant~     and Toddler (PCM-IT) version.~   "
64816|NCT02208921|"~     This non-interventional, multi-centric, cross-sectional study is aimed to determine the~     prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000~     patients will be enrolled from 30 investigative sites all over the country. Each~     investigative site will be expected to enrol 100 subjects. All the procedures will be~     completed in a single day.~   "
64817|NCT02208908|"~     The purpose of this study is to measure the impact of training on the practical assessment~     and management of the oral status of patients hospitalized in palliative situation.~   "
64820|NCT02208869|"~     True prevalence of FH in the Russian Federation is unknown which leads to low percentage of~     diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific~     diagnostic algorithms and optimal treatment strategies. The main aim of the present study is~     to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian~     Federation for reduction of cardiovascular risk related to atherosclerosis in the country.~      As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be~     determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5~     mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass~     through non-invasive clinical examination at the Russian Cardiology Research and Production~     Center, including patient demographics, past medical history, family history of~     hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests,~     genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in~     selected cases. On the basis of the Moscow Program four major Federal Medical Centers will~     be involved, and FH Registry will be created as a national, multi-center initiative to~     screen FH patients, control their diagnosis and management, and track clinical-reported~     outcomes over time.~      Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of~     these data and implementation those into clinical practice in different regions of Russia~     will allow improving patient care. As an expected outcome, this program will raise awareness~     and increase appropriate assessment and treatment of FH patients in Russia, leading to a~     timely detection of the disease and therapy initiation.~   "
64821|NCT02208856|"~     To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single~     doses, with and without a 64 g fat breakfast at one selected dose.~   "
64822|NCT02208843|"~     The objectives of this single-arm, open-label trial are to assess the efficacy and safety of~     afatinib as second line treatment for patients with locally advanced or metastatic non-small~     cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line~     platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable~     to the results seen in previous trials.~   "
64823|NCT02208830|"~     The hypothesis of this study is that the group of patients who will carry out the~     rehabilitation program associated with respiratory therapy will have higher benefits in~     physical function, peripheral muscle strength and quality of life compared to the group that~     will only perform chest physiotherapy. Additionally, there will be a negative correlation~     between inflammatory mediators and measures of physical ability as well as the magnitude of~     improvement is lower after treatment in patients with higher baseline levels of~     inflammation.~   "
64824|NCT02208817|"~     2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies~     in recognising and managing sick children. Key recommendations from both reviews included~     the development and adoption of 'track and trigger' or a paediatric early warning score~     (PEWS) to better identify the sick or deteriorating child. PEWS tools offer the potential to~     identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a~     measure of skin blood flow and is a vital part of many early warning and resuscitation~     scores. It is a sensitive marker of infection and dehydration in children. However, due to~     how it is performed and interpreted CRT is prone to marked variability between observers.~      We have Medical Research Council (MRC) funding to develop an automated capillary refill~     device and user interface to provide a paediatric continuous early warning (PaedCEW)~     monitoring system. The PaedCEW system would complement and support current clinical practice~     and aim to address the difficulties of recognising ill children.~      We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2~     matched controls without significant illness from the Nottingham Children's Hospital. The 20~     ill children will have their CRT (and PaedCEW score) monitored before, during and after~     admission to PICU. This will allow correlation with invasive (BP, central venous oxygen~     saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of~     cardiovascular status during periods of stability and compromise. Matched controls will be~     monitored for around 24 hours. This pilot study will allow development of our system.~      This is a proof of concept study. This study aims to demonstrate a novel device for~     measuring CRT. Its correlation with noninvasive measures of cardiovascular status will~     enable a pragmatic comparison with current clinical practice. In addition, correlation with~     invasive measures of cardiovascular status will enable us to calculate sensitivity,~     specificity, negative predictive value (NPV) and positive predictive value (PPV).~   "
64825|NCT02208804|"~     The objective of the SIM trial is to investigate whether using the Surefire Infusion System~     during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity~     concentration ratio, compared with using a standard end-hole microcatheter.~   "
64826|NCT02208791|"~     The purpose of this study is to determine the effects of sirolimus in the phenotype of~     peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory~     phenotype and in the development of anti-HLA antibodies among kidney transplant recipients~     with high immunological risk for graft rejection.~   "
64827|NCT02208778|"~     Osteoarthritis (OA) is a degenerative joint disease and is the most common form of~     arthritis. Pain reduction and functional recovery are the key elements of the clinical~     management of OA. Current treatment guidelines recommend a combination of pharmacological~     and non-pharmacological treatments. However, these are not always effective, with nearly 20%~     of patients not responding to any standard therapy, including joint replacement.~      The mechanisms of pain relief are not well understood and are complicated by the remarkably~     large placebo effect, and inter-individual variation. There is no objective criteria for~     predicting whether a patient will respond to a given treatment~      Duloxetine, an antidepressant drug, has proven effectiveness in various chronic pain~     syndromes including knee OA. The effect is however limited and only clinically relevant in~     around half of the trial patients. Importantly, it is currently unclear how and in whom~     duloxetine alleviates chronic pain.~      Advanced MRI techniques use strong magnetic fields and radio frequency signals to generate~     metabolic, anatomical and functional brain images (fMRI).~      Remifentanil is a potent analgesic agent whose analgesic effect has been well characterised~     in healthy volunteers, including fMRI studies showing modulation of activation of regions in~     the brain related to pain processing. Nevertheless, the neural correlates of remifentanil~     effects have not yet been investigated in chronic pain patients.~      The aim of this research is to use a combination of multimodal MRI, genetic and psychometric~     assessments to identify the mechanisms of pain relief in knee OA patients, following~     treatments with duloxetine and remifentanil, in a placebo controlled condition. With this we~     also aim to identify genetic, anatomical and brain activity predictors of treatment~     outcomes.~      The main hypotheses are:~        -  Analgesic response to duloxetine treatment can be predicted using a range of baseline~          brain imaging markers and QST.~        -  Analgesic response to duloxetine is mediated by modulation of neural networks~          underpinning emotional control.~        -  Duloxetine-induced changes in brain activation differ between responders and~          non-responders.~      This study is expected to last for two years. It is funded by Arthritis Research United~     Kingdom and forms part of a wider scientific investigation, using translational~     methodologies, to enhance the understanding of arthritis pain and to improve its treatment.~   "
64839|NCT02208622|"~     Bioavailability of iron and zinc from habitual plant-based diets consumed by young children~     in Mexico is low due to the high phytate content. Whey protein has been found to increase~     zinc absorption, thus, providing a whey based supplement with micronutrients may be an~     effective strategy to increase iron and zinc bioavailability from plant-based foods and~     alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron~     in children receiving diets with and without whey protein supplements (WPS).~   "
64828|NCT02208765|"~     Endothelial dysfunction has been demonstrated to be an early marker of coronary artery~     disease (CAD). On the other hand, myocardial perfusion single photon emission computed~     tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected~     or known CAD.~      Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate~     marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its~     additive and independent prognostic value over the presence of myocardial ischemia remain~     unknown.~      Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial~     perfusion heterogeneity assessed by a new automatized image processing method applied to~     routine MP-SPECT.~      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive~     of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department~     for routine evaluation of known or suspected CAD.~   "
64829|NCT02208752|"~     This is a randomised controlled study involving a group of 20 patients- 10 patients in a~     control group, 10 patients in treatment group. The treatment group consists of exercises~     with theraband for the shoulder and exercises of motor control of the scapula. The purpose~     of the study is to measure the effects of a pre-operative physiotherapy program for patients~     awaitng for rotator cuff surgery, The duration of the pilot project is 4 weeks.~   "
64830|NCT02208739|"~     Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic~     inflammatory disease of the periodontium which results in irreversible destruction of~     supporting structures of the teeth such as periodontal ligaments, connective tissues,~     cementum and alveolar bone. More than 700 species of bacteria are estimated to be found in~     the sub-gingival dental biofilm in which periodontopathogens are found to be responsible in~     initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts~     as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for~     the systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide~     (LPS) from gram-negative bacteria with host cells initiates the secretion of cytokines and~     the expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar~     bone and connective tissues supporting the teeth.~      In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which~     includes oral hygiene instruction (OHI), scaling and root planing, is administered to~     improve clinical parameters as well as controlling the bacterial count responsible in~     initiating the disease and the resultant inflammatory response. Success of the treatment can~     be analyzed when the clinical parameters, counts of the microbes is reduced and inflammatory~     response is controlled. Studies which have evaluated the microbiological and immunological~     response following NSPT clearly demonstrates an improvement in clinical parameters,~     reduction in inflammatory mediators present as well as a decrease in microbial count.~      OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing~     microbial plaque, thus, preventing periodontal diseases such as gingivitis and~     periodontitis. Studies have evaluated the role of OHI on clinical and immunological~     parameters and microbiological profiles of periodontal maintenance subjects, while none of~     them evaluated its role alone in the management of chronic periodontitis subjects.~     Therefore, the purpose of the following investigation was to compare the changes in the~     clinical parameters, inflammatory mediators as well as level and frequency of detection of~     periodontopathogens that take place after 3-months of NSPT versus OHI and to evaluate if~     clinical parameters have an effect on these inflammatory mediators and microbiological~     changes.~   "
64831|NCT02208726|"~     Increased levels of stress and anxiety are experienced by many students. Stress can have a~     negative influence on academic outcome and performance, as well as on the student's mental~     health. Conventional treatment options for anxiety include counseling, as well as~     anxiolytics and antidepressants, which may have various adverse effects. Picricum acidum and~     Phosphoricum acidum are homeopathic remedies that may be helpful in alleviating anxiety in~     students; however there has been no research done to date to show their efficacy for this~     condition.~      The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum~     Homaccord on perceived levels of anxiety in university students, by means of the~     State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.~   "
64832|NCT02208713|"~     Facioscapulohumeral Dystrophy is a Autosomal dominant inherited dystrophy with the~     prevalence of 1:20,000 and it is the third most common dystrophy after the~     dystrophinopathies and myotonic dystrophy. The symptoms including: Pain, facial weakness,~     scapular fixator, humeral, truncal, pelvic girdle and lower-extremity weakness, High~     frequency hearing loss, Retinal telangiectasia . The existing treatments are not effective~     so, cell therapy is a new hope to improve patients' quality of life. Therefore, We design~     this clinical trial to evaluate the safety and feasibility of stem cell transplantation.~   "
64833|NCT02208700|"~     Patients with mechanical ventilation have shown improved weaning rates when enteral tube~     feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.~      LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical~     ventilation, decreased mortality rates and decreased organ failure when fed an enteral~     product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral~     nutrition product.~   "
64834|NCT02208687|"~     Fatigue is present in at least 60% of the patients with a muscle disease and can be the most~     disabling symptom. In combination with other impairments, this often results in low levels~     of physical activity and decreased social participation, leading to large societal costs.~     Energetic is a self-management group program aimed at improving participation and physical~     endurance in these patients. Our hypothesis is that Energetic results in improved~     participation and improved physical endurance, less experienced fatigue and better quality~     of life compared to usual care, without increasing health care costs.~   "
64835|NCT02208674|"~     Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased~     risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized~     clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and~     hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is~     screened and treated according to recommended guidelines. Using a cluster-randomized,~     controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize~     6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a~     pharmacist-directed CKD Action Plan (group 2). Determining the impact of the CKD Action~     Plan on screening and treatment guideline adherence is the primary goal of this pilot study.~   "
64836|NCT02208661|"~     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal~     recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage~     diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes~     of and finding a treatment for the physical aspects of the various diseases. Less attention~     has been paid to the psychological or emotional toll of these diseases, whether they are~     direct symptoms of the diseases themselves or reactions to living with a chronic progressive~     disease.~      It is well established in the health psychology literature, however, that the interaction~     between our physical health and our psychological health is bidirectional; that is, just as~     our physical health affects us emotionally (e.g. chronic pain can contribute to depression),~     so can our psychological health affect us physically (e.g. anxiety can contribute to~     feelings of chest pain).~      Prior to 2013, there was currently neither a cure nor treatment (other than palliative) for~     Morquio disease, although clinical trials with enzyme replacement treatment (ERT) were~     ongoing. In the latter half of 2013, ERT became available to the broader population of~     patients with Morquio A disease through BioMarin's Expanded Access Program.~      In a previous study, entitled Psychological Concomitants of Morquio syndrome the present~     investigator enrolled 20 adult subjects with Morquio disease into a pilot study designed to~     estimate a baseline incidence of psychological symptoms and overall quality of life.~     Subjects were all over the age of 18. The study was conducted with the timing of the release~     of BioMarin's Expanded Access Program in mind; i.e. all subjects in the study were naïve to~     enzyme replacement therapy, permitting baseline natural history data on psychological~     symptoms in Morquio syndrome. Data from this research study are presently being analyzed and~     should be published within 2014.~      The present study extends this research into psychological health in Morquio disease by a~     comparison of psychological issues and quality of life before and after treatment (i.e.~     ERT), to determine whether or not treatment of the physical symptoms by themselves reduces~     psychological issues and improves quality of life. As ERT does not cross the blood-brain~     barrier, it would be unlikely to improve organic psychological symptoms of Morquio disease,~     but might improve any reactive psychological symptoms caused by living over time with this~     chronic progressive genetic disease.~      The present study thus seeks to follow adult patients with Morquio A disease as they begin~     ERT and track their psychological health every 6 months for a duration of 2 years.~     Longitudinal tracking of subjects' psychological symptoms and comparison with baseline data~     is the goal of the present study.~      Adult patients with Morquio disease are invited to participate. Once consented, patients~     will be asked to complete three different self-report questionnaires, including the~     Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report (ASR) or Older~     Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health Questionnaire (SF-36),~     and the Brief Pain Inventory (BPI). Group aggregate data only will be reported; individual~     questionnaire content and results will be held confidential, except as in accordance with~     Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent.~   "
64837|NCT02208648|"~     The study will investigate whether the presence of coronary artery calcium as demonstrated~     on pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor~     for 90 day mortality in patients undergoing major abdominal surgery.~      The study research question: Do higher levels of coronary calcification correlate to an~     increased risk of post-operative mortality in patients undergoing major abdominal surgery?~   "
64838|NCT02208635|"~     The objective of this study is to compare the quantity of Zn absorbed from an accurately~     weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from~     biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified~     (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major~     habitual food staple is maize.~   "
64840|NCT02208609|"~     Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets~     and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.~     Supplementation of Zn to children during diarrhea episodes has been shown to diminish~     duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this~     diet might play a role in these processes. Supplementation of this micronutrient in the diet~     might be beneficial. The investigators will compare absorption of Zn from white maize~     tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool~     children in Guatemala.~   "
64841|NCT02208596|"~     To explore the feasibility of different doses of etomidate admixed with propofol in induced~     abortion: a randomized, double blind controlled trial.~   "
64842|NCT02208583|"~     To explore the molecular phenotypic changes and personalized treatment in~     castration-resistant prostate cancer.~   "
64843|NCT02208570|"~     The purpose of this study is to find out the predictability of the pulse pressure variation~     during spontaneous ventilation on the incidence of hypotension during induction of~     anesthesia.~   "
64844|NCT02208557|"~     Background: Development of an incisional hernia is one of the most frequent complications of~     midline laparotomies requiring reoperation. This paper presents the rationale, design, and~     study protocol for a randomized controlled trial, the aim of which was to evaluate the~     efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for~     reinforcement of a midline fascial closure.~      Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable~     mesh) is a multicenter randomized controlled trial in which adult patients undergoing~     elective or urgent open abdominal operations through a midline laparotomy incision are~     assigned to one of two groups based on the laparotomy closure procedure: an intervention~     group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially~     available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff,~     Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed~     over 6 months.~      Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical~     examination at clinical visits and radiologically (CT scan) performed at the end of~     follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma,~     burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate~     that suture plus prosthetic mesh insertion for routine midline laparotomy closure is~     effective in preventing incisional hernias after open abdominal surgery, to avoid the~     effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality~     of life, and to save costs potentially associated with incisional hernia surgical repair.~   "
64845|NCT02208544|"~     The purpose of this study is to determine whether the use of molecular imaging using~     FDG-PET/CT could prevent unnecessary diagnostic thyroid surgery in case of indeterminate~     cytology during fine-needle aspiration biopsy.~   "
64846|NCT02208531|"~     We hypothesize that it is feasible to integrate a program of Nutritional Care and~     Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve~     malnourished children's growth and development after a year of intervention.~   "
64847|NCT02208518|"~     Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and~     staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis~     of solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided~     fine needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been~     introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses,~     being an index of tissue elasticity, which may be related to histopathology features (hard~     tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However,~     recently publications show different results using elastography. Moreover, a lack of data in~     Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the~     diameter of the region of interest under analysis in previously studies that by physics~     could affect the tissue elasticity.~      Based on the hypothesis that elastography could be affected by compression rate of the probe~     and the diameter of the region of interest analyzed the present study aimed to evaluate the~     quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results~     determined by the compression rate of the probe (measured by the curve of compression in the~     second generation of elastography) and the diameter of the region of interest in normal~     pancreatic tissue.~   "
64848|NCT02208505|"~     After thyroid surgery, the incidence and severity of coughing is important because it may~     cause serious complications, such as bleeding in the surgical field, laryngospasm, and~     cardiovascular disturbance. Several studies have shown that the single-dose of~     dexmedetomidine is effective for reducing cough and agitation during emergence from general~     anesthesia.~      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose~     remifentanil infusion during emergence from general anaesthesia could reduce coughing as~     good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression~     and reduction of side effect of remifentanil using non-inferiority trial.~   "
64849|NCT02208492|"~     Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as~     levetiracetam are reported to have less adverse effect in children but not many studies have~     systematically reviewed the subject. This study aims to prospectively evaluate the effect of~     levetiracetam on neurocognition, behavioral issues and quality of life, as well as its~     seizure control efficacy and other adverse events in pediatric epilepsy patients, in~     comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed~     for both partial and generalized seizures, despite its well known side effects.~      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from~     age 4 to 16 woh will be randomized into two groups, which will be prescribed with~     levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and~     life evaluations of the patients will be performed at baseline period and after the 52 weeks~     of study period.~   "
64850|NCT02208479|"~     Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical~     ventilation and cause respiratory distress.~      The investigators' main objective is to determine the incidence of diaphragm dysfunction (~     using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic~     thickening fraction) in a selected population of cardiac surgery patients during weaning~     from mechanical ventilation.~      The second endpoints are to determine the associated risk factors to post-operative~     diaphragm weakness and the consequence on the patient outcome.~   "
64853|NCT02208440|"~     This is a post-marketing study to further assess the safety and effectiveness of the~     InSpace™ device implantation in comparison to surgical repair of full thickness Massive~     Rotator Cuff Tear .~      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick~     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily~     living (ADL) and improvement of range of motion (ROM).~   "
64854|NCT02208427|"~     Background:~      Tuberculosis (TB) remains the most important infectious disease in the world. Keys to~     successful control of TB is rapid diagnosis, prompt treatment, as well as effective~     preventive therapy for contacts with latent TB infection (LTBI). Current methods for the~     diagnosis of LTBI are tuberculin skin test (TST) and interferon-gamma release assay (IGRA).~     For preventive therapy, the recommended regimens include daily isoniazid for 9 months and~     daily rifampicin for 4 months. By incorporating long-acting rifapentine, a new regimen~     combining weekly rifapentine and high-dose isoniazid for a total of 12 doses has been proven~     of equal potency and toxicity. However, the treatment completion rate is much higher in~     weekly treatment for 3 months than daily treatment for 9 months. It is reasonable that using~     rifapentine-based preventive therapy can markedly increase the completion rate. However,~     study is lacking, especially in Asia, the high endemic area of TB.~      With the effort of all health care workers and public health personnel, the incidence of TB~     in Taiwan has gradually declined in recent 10 years. In order to maintain the trend of~     decreasing in incidence, preventive therapy for LTBI become more and more important.~     However, which is the best preventive regimen for LTBI is still unknown. Therefore, we~     conduct the prospective randomized multicenter studies to compare the treatment completion~     rate of two regimens in Taiwan. The first regimen is daily isoniazid for 9 months. The~     second is weekly rifapentine plus high-dose isoniazid for 3 months.~   "
64855|NCT02208414|"~     Purpose of this study is to determine whether NAET procedures are effective in the treatment~     of crab or shrimp allergy.~      Hypothesis: experimental group will show a significant improvement over the control group in~     allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp~     extract.~   "
64856|NCT02208401|"~     Different modalities are employed to remove small colonic polyps which potentially harbour a~     cancer risk. But, they can all vary in their completeness of removal, safety and the~     histological quality and the gold standard technique has yet to be defined. A novel suction~     pseudopolyp technique has been described by Patullo et al and in their prospective study,~     126 polyps measuring less than 10mm flat or sessile were removed by this method with 100%~     complete endoscopic resection and without any immediate or delayed complications. The aim of~     the investigators study is to compare this technique with the standard cold snare technique.~     Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size~     will be eligible and they will be randomised to the polypectomy technique. Patient~     demographics and polyp characteristics will be recorded. The primary outcome measured will~     be the macroscopic resection rate. The secondary outcome measures are abdominal pain,~     tenderness, bleeding and fever.~   "
64857|NCT02208388|"~     The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography~     perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization~   "
64858|NCT02208375|"~     The goal of this clinical research study is to learn about and compare the highest tolerable~     doses and combinations of the drugs Lynparza™ (olaparib), AZD2014, and AZD5363 that can be~     given to patients with recurrent endometrial, triple negative breast, ovarian, primary~     peritoneal, or fallopian tube cancer. The safety of these drugs and drug combinations will~     also be studied.~   "
64859|NCT02208362|"~     This phase I trial studies the side effects and best dose of genetically modified T-cell~     immunotherapy in treating patients with malignant glioma that has come back (recurrent) or~     has not responded to therapy (refractory). A T cell is a type of immune cell that can~     recognize and kill abnormal cells in the body. T cells are taken from the patient's blood~     and a modified gene is placed into them in the laboratory and this may help them recognize~     and kill glioma cells. Genetically modified T-cells may also help the body build an immune~     response against the tumor cells.~      Funding Source - FDA OOPD~   "
64860|NCT02208349|"~     The goal of this study is to compare the first pass success rate of intubation between video~     assisted intubation and traditional direct visualization intubation in the field by~     Emergency Medical Service (EMS) professionals~   "
64861|NCT02208336|"~     This research trial studies electronic medical record review in monitoring the effects of~     adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors~     receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone~     marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and~     platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to~     having a symptom of disease or medical problems caused by a treatment. Monitoring patients'~     electronic medical records to compare side effects, such as myelosuppression and morbidity,~     with treatment adherence may be a way to enhance patient care by organizing data for medical~     staff.~   "
64862|NCT02208323|"~     This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs~     to fit older children, will create a safe form of respiratory support that may help to~     decrease respiratory distress and thus mortality from pneumonia.~   "
64863|NCT02208310|"~     Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight~     is a major source of vitamin D. There is some research to suggest that patient's with higher~     vitamin D levels are less likely to undergo surgeries and have better control of their~     disease. We intend to study the effects of high dose vitamin D supplementation in patients~     with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses~     will have less hospitalizations, surgeries, steroid use.~   "
64864|NCT02208297|"~     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate~     (LE) ophthalmic gel, 0.38% (BID)~   "
64865|NCT02208284|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single oral doses of PF-06427878 in healthy adult subjects.~   "
65698|NCT02197403|"~     1. Adequate sedation with classical sedative agents, propofol~        2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol~          drinkers~        3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol~          drinkers~   "
64866|NCT02208271|"~     The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for~     adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip~     replacement.~      A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal~     revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant,~     control group) will be enrolled. Preoperative blood serum samples and intraoperative~     synovial fluid will be obtained from all hips and used for biomarker testing. Additionally,~     intraoperative assessment of tissue necrosis will be assessed.~   "
64867|NCT02208258|"~     The purpose of this study is to evaluate the safety, efficacy, and functionality of the~     Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal~     incontinence.~   "
64868|NCT02208245|"~     The brachial plexus block is an anesthetic technique often used for surgical procedures of~     the upper limb. To get the brachial plexus block, several routes can be used, including the~     axillary and infraclavicular approach.~      Few studies have compared these techniques, considering the time to perform the block, the~     onset time and success rate, with conflicting results. Furthermore, there is little~     information in the literature comparing the length of postoperative analgesia provided by~     these techniques.~      Therefore, the investigators designed this study in order to elucidate the differences~     between these two techniques to assist the anesthesiologist to choose the best of them in~     clinical practice.~   "
64869|NCT02208232|"~     The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125~     AS IOL.~      At the end of surgery the orientation of the IOL is documented with a short video clip via~     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6~     months after surgery. Rotational stability of the IOL is assessed using retroillumination~     images with a method to avoid bias from cyclorotation or head tilt.~   "
64870|NCT02208219|"~     Motor deficits are common after stroke, being one of the major causes of disability in this~     population. Because of the impact that motor impairments have in the life of patients and~     the associated financial costs, it is a health care priority to develop effective and~     efficient treatments to restore motor deficits. Music-supported therapy (MST) has been~     recently developed to enhance the use of the affected extremity after stroke.~      In the present project, a new multidisciplinary approach (neurology, neuropsychology, music~     and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of~     MST as a neurorehabilitation technique to restore the motor function in stroke patients. In~     addition, the complex pattern of reorganization of the sensorimotor system will be studied~     in order to provide information about the physiological mechanisms underlying the~     neurorehabilitation process.~      A randomized controlled trial is proposed to compare for first time the effectiveness of MST~     (at the hospital and at home) compared to conventional treatment in subacute stroke patients~     suffering from motor deficits. Our hypothesis is that patients will experience a large~     improvement in the functional use of the affected arm due to the implementation of the MST~     program when compared to conventional treatment. We also expect to observe improvements in~     cognitive functions, mood and quality of life. Besides, we hypothesize that these~     amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in~     the sensorimotor cortex and corticospinal tract.~   "
64871|NCT02208206|"~     The purpose of this study is to analyze associations between symptoms and specific markers~     in the blood in patients suffering from neuropathic pain linked to diseases of different~     origin. Such markers could be utilized in the future for precise diagnosis of neuropathic~     pain and might lead to targeted pain treatment.~   "
64872|NCT02208193|"~     Gardens and art represent public spaces and support venues of interactions and emotions,~     seeking not only a variety of conversational themes but also various cognitive skills such~     as mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden,~     jointly associated and made available to patients suffering from Alzheimer's disease, need~     to be evaluated.~      MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on~     cognitive and emotional processes by means of interview analyses in Alzheimer patients and~     control subjects based on the  art, memory and life  garden.~      SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer~     patients:~        -  create assessment methods of:~        -  the therapeutic efficacy of the design of the  art, memory and life  garden,~        -  the perception of an artistic dimension in the living environment of those with~          Alzheimer's disease,~        -  establish:~        -  workshop applications using art and the garden for therapeutic purposes,~        -  general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative~          data of discursive productions stemming from Interlocutory Logic (Trognon and Batt,~          2007, 2010, 2011) for the analysis of interactive behaviors and the assessment of~          parameters including esthetic appraisals, well-being, mnemonic and emotional processes~          (frequency and nature of these processes) as well as spatio-temporal orientation.~      SECONDARY ENDPOINTS~        -  Scores obtained in standard neuropsychological tests, in particular to assess~          spatio-temporal orientation (Folstein MMSE),~        -  Scores obtained with the  MemoArtZ  tool (MAZ) to evaluate the memorization of~          artistic elements of the garden,~        -  Scores from the  General Esthetic Preference  (GEP) tool to evaluate the consistency~          of general esthetic appreciations,~        -  Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,~        -  Score obtained with the specific assessment of emotional events scale (AES) for all~          subjects.~      RESEARCH METHODOLOGY~      Open, monocentric, controlled (group of healthy control subjects) study.~      Population: 2 groups:~      Group A Alzheimer group: patients with mild to severe stages of Alzheimer's disease:~     subgroup A1 Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul~     Spillmann, CPS) (CHU de Nancy, France); subgroup A2 Alzheimer group monitored at the~     Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)~     (CHU de Nancy, France) Group B healthy control group: healthy volunteers~      Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care~     management, notably: i) by determining the design, conception and layout of the gardens~     destined to these patients, ii) by developing the introduction of an artistic dimension to~     the design of such healing gardens and in their living environment, iii) by establishing~     workshop application perspectives using the contemplation of works of art and the garden for~     therapeutic purposes.~   "
64873|NCT02208180|"~     The investigators are conducting a two group intervention to study to the effect of~     individualized heart disease genomic risk results on motivation towards diet and physical~     activity behaviors to reduce heart disease risk. The intervention includes provided~     participants with genomic and lifestyle risk estimates. Investigators will follow~     participants for 3 months to determine if motivation towards and engagement in diet and~     physical activity behaviors change.~   "
64874|NCT02208167|"~     This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic~     efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in~     HIV-infected individuals with viral suppression on antiretroviral therapy (ART).~   "
64886|NCT02208011|"~     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as~     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart~     review after delivery.~      Inclusion Criteria:~        -  English speaking~        -  pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes~      Exclusion Criteria:~        -  Known placental previa~        -  Active vaginal bleeding~   "
65766|NCT02196519|"~     A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the~     anastomotic junction created during a stoma reversal procedure.~   "
64875|NCT02208154|"~     Previous research has shown that applying certain treatments can reduce both the number of~     infections and the presence of resistant bacteria in the intensive care (ICU) and its~     patients. These treatments have been used as standard care throughout the world for many~     years, but they have not been compared to each other yet. The investigators aim to evaluate~     the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial~     infections in the ICU and to establish which treatment is the best.~      All adult patients undergoing mechanical ventilation are eligible for this study and will~     receive treatment according to the study scheme. Twice weekly, sputum and rectal samples~     will be obtained to measure the effects.~      All ICU-patients will receive standard treatment, consisting of daily body washing with an~     antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers~     as endorsed by the WHO. According to 4 different study periods, each participant will~     receive one of the following extra treatments depending on his or her admission date:~        -  Standard treatment only (this is the control group)~        -  Chlorhexidine 1% oral gel, this is an antiseptic.~        -  Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal~          decontamination, SOD).~        -  Antibiotic mouth paste and suspension for the stomach and intestines containing 3~          different antibiotics (selective digestive decontamination, SDD).~      All treatments will be given 4 times daily with the purpose of killing harmful bacteria in~     the mouth (CHX, SOD,SDD) and digestive tract (SDD).~      During the study the investigators will examine the effect of these treatments on:~        -  the occurrence of blood stream infections with certain bacteria~        -  cross-transmission of certain bacteria between patients~        -  presence of these bacteria in the respiratory tract of the patients~        -  patient survival~      Benefits: Previous research has shown that these interventions can reduce infections in~     intensive care patients.~      Risks: The interventions performed (both cultures and treatment) are considered safe and are~     already given as standard care in many ICUs throughout the world. There is a slight risk~     that bacteria become resistant to antibiotics: this will be monitored closely during the~     trial.~   "
64876|NCT02208141|"~     In this study the investigators hypothesize that pathological alterations in adipose tissue~     biology already occur during the development and progression of obesity in children and~     adolescents. The investigators aim to identify and characterize mechanisms and molecular~     targets that affect the development of adipose tissue and ensuing obesity in childhood and~     adolescence.~   "
64877|NCT02208128|"~     Aim of the scientific analysis is to find biological factors (biomarkers) allowing a~     prediction of disease progression and a better choice of therapy. After diagnosis the kidney~     and the tumor will be removed by standard surgery followed by drug therapy. Within surgery~     remaining tumor tissue will be used for the scientific analysis. In case of disease~     progression during the drug treatment the drug therapy will be changed. Before therapy~     change a small tissue sample will be collected for molecular diagnostics. This will be done~     by puncture through the skin under local anesthesia. Blood samples taken before surgery and~     at the time of first and second disease progression will also be used for~     molecular-biological analysis. As there is no clear recommendation for drug therapy after~     disease progression this study should serve to determine an individual therapy on the basis~     of the molecular profile and the molecular changes. As the tumor disease changes and~     developes resistance to drugs, analysis at the time of disease progression shall identify~     biological factors which will predict a likelihood response to a specific drugs.~      This shall allow to give the patient an individual therapy.~   "
64878|NCT02208115|"~     The investigators hypothesise that manipulating the glycaemic index of the meal after~     exercise will influence the acute appetite responses of Type 1 diabetes individuals~   "
64879|NCT02208102|"~     The purpose of this study is to assess if pre-ablation levels of inflammatory biomarkers~     serve as independent predictors of procedure outcome To evaluate the inflammatory activation~     following catheter ablation by measuring serum-biomarker levels 24-hours after the procedure~     and examine the predictive role in procedure success To study the association of certain~     biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)~   "
64880|NCT02208089|"~     Young patients with keratoconus face two problems: disease progression and corneal shape~     irregularity leading to poor vision even in spectacles.~      Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression~     in keratoconus. The aim is to stiffen the cornea thereby preventing further shape~     deterioration.~      Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses~     the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal~     shape irregularity in early stage keratoconus, reducing dependence on contact lenses.~      In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure,~     preparing the cornea for CXL. Performing both treatments simultaneously (combining both~     procedures in one operation) may offer several advantages over performing CXL first then~     waiting for corneal shape to stabilise before performing transPRK. In particular, visual~     rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous~     CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients~     will be compared with results for a similar group of patients with early stage keratoconus~     who have already been treated with CXL alone.~   "
64881|NCT02208076|"~     This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®~     via easypod™.~   "
64882|NCT02208063|"~     This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus~     standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin~     (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S.~     aureus) bacteremia and SA right-sided infective endocarditis (RIE).~   "
64883|NCT02208050|"~     The purpose of this study is to examine the effect of treatment with fampridine in patients~     with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb~     dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in~     the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the~     Jebson Taylor Hand Function Test (JTT).~      Fampridine has been shown to be effective in improving motor function, specifically walking~     ability in prior studies in this patient population and is currently licensed for this use~     in Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often~     underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres~     and we would hypothesise that the improvement previously reported in walking ability would~     be similar to that on upper limb dysfunction. Our study aims to address this question using~     both independent and patient reported outcomes in the context of a randomised placebo~     controlled crossover trial.~   "
64884|NCT02208037|"~     Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality~     after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to~     determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and~     relapse free survival at one year after transplant compared to the current standard~     prophylaxis regimen.~   "
64887|NCT02207998|"~     Osteoarthritis (OA) is a chronic arthropathy characterised by disruption and possible loss~     of joint cartilage along with other joint changes. OA symptoms include progressively~     developing joint pain provoked or elicited by activity, joint stiffness that lasts for less~     than 30 minutes on waking and after activity, and occasional joint swelling. It is a common~     specific mechanical cause of chronic low back pain. Conventional treatment for OA includes~     physiotherapy treatment and drugs such as paracetamol, non-steroidal anti-Inflammatory drugs~     (NSAIDs), intra-articular injection of corticosteroids and surgery, however these may have~     possible side effects. Arnica montana, Bryonia alba, Rhus toxicodendron, Causticum, Kalmia~     latifolia and Calcarea fluoride are homoeopathic remedies indicated and used in the~     treatment of OA, however, there is no evidence of studies conducted on a complex made up of~     these remedies.~      The aim of the study is to investigate the efficacy of the homoeopathic complex (Arnica~     montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH~     and Calcarea fluoride 6CH) and physiotherapy in the treatment of chronic low back pain due~     to osteoarthritis, using the Oswestry Low Back Pain Disability Questionnaire, range of~     motion (ROM) measurement using the attraction tape and the visual analogue pain scale (VAS)~     .~   "
64888|NCT02207985|"~     Aim:~      To study the antitumour effect of reduced intensity conditioning (RIC) with allogeneic stem~     cell transplantation (HSCT) in patients with pancreatic adenocarcinoma after radical~     resection of the tumour and adjuvant treatment with standard chemotherapy.~      Importance:~      If investigators can accomplish an anti-tumour effect using RIC with HSCT as adjuvant~     treatment in patients with pancreatic adenocarcinoma, it might increase the survival or even~     cure patients in this group with very poor prognosis.~      Primary scientific question:~      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using~     adjuvant treatment with HSCT?~      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using~     adjuvant treatment with HSCT?~   "
64889|NCT02207972|"~     The investigators believe that ultrasound guided CSE technique will accurately place the~     epidural needle in the midline position compared to epidural needle placement via palpation~     of anatomical landmarks. This will result in positive CSF in the spinal needle, correct~     placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.~   "
64890|NCT02207959|"~     The overall objective of this pilot study is to determine whether multispectral imaging~     increases the diagnostic accuracy of the current standard of high-definition white-light~     endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part~     of an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic~     platform that can be used to survey a large surface area and, potentially, serve as a red~     flag for microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical~     and endoscopic specimens, the investigators have identified the optical settings and~     illumination wavelengths that are complementary to white-light imaging and enhance~     superficial mucosal and vascular changes associated with neoplasia. Based on this initial~     testing, vital-dye enhanced fluorescence imaging (VFI) and imaging with High Resolution~     Microendoscope (HRME) have been identified as modalities that may be complementary to~     white-light imaging. The goal of this pilot study is to preliminarily determine the accuracy~     of these modalities during the endoscopic surveillance and detection of gastric neoplasia.~   "
64891|NCT02207946|"~     The objective of this study is to assess the efficacy and safety of a single,~     kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in~     moderate to marked essential tremor of the upper limb.~   "
64892|NCT02207933|"~     To investigate the effect of anteroposterior weight shifting training with visual~     biofeedback on step length asymmetry. Reduced speed and asymmetry of stepping is a specific~     characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step~     length of the unaffected limb compared to the affected limb. Causes of this phenomenon are~     difficulty in weight bearing at the affected limb, weak propulsive force of the affected~     limb, and decreased strength of hip extensors. To correct these factors. we have developed~     an anteroposterior weight shifting training system with visual feedback and studied its~     effects.~   "
64893|NCT02207920|"~     This study will evaluate the safety, tolerability, and immune response to different~     combinations of two experimental HIV vaccines—the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E~     vaccine—in healthy adults who are not infected with HIV.~   "
64894|NCT02207907|"~     The primary objectives of this study will be to compare the Gingival Bleeding and Gingival~     Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice~     compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be~     conducted at Silverstone Research Group. Participants will be recruited from their database~     and by use of an external recruitment agency.~   "
64895|NCT02207894|"~     This research program is initiated to evaluate and document data on the success of ITI in~     300 haemophilia A patients with newly developed or already existing FVIII-inhibitors (also~     patients who might potentially have failed in earlier ITIs), which will be treated with ITI~     - preferably high-dose based on individualized product selection, in order to improve~     management of this potentially devastating complication of haemophilia treatment.~      In order to investigate the role of in vitro tests on individual ITI success rate in~     patients undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII~     concentrates using the following in vitro tests: Batch selection, Thrombin generation assay~     (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG~     Subclasses specific for FVIII, Immunogenotyping.~   "
64904|NCT02207777|"~     For this purpose, we will compare the effects of 16-18% weight loss induced by Roux-en Y~     Gastric bypass (RYGB) surgery, biliopancreatic diversion with duodenal switch (BPD), or~     sleeve gastrectomy (SG) surgeries with the same weight loss induced by laparoscopic~     adjustable gastric banding (LAGB) or a low-calorie diet (LCD) on liver and skeletal muscle~     insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects~     with T2D.~   "
64949|NCT02207192|"~     Postural changes are known to affect normal lung volumes. A reduction in sitting to supine~     functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine~     position. However, postural changes in lung volumes in the obese require further~     exploration. We aimed to longitudinally address the effects of weight loss on postural~     changes in lung volumes and pulmonary function, in obesity. We tested the hypothesis that~     supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.~   "
64896|NCT02207881|"~     Recurrent herpes labialis are usually a minor malady of limited duration, although they are~     often painful and are uniformly discomforting for patients. Oral antivirals represent an~     advance in the treatment of recurrent herpes labialis, but the clinical implications are~     modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the~     duration of lesion episodes and pain by approximately one day. In recurrent HSV infections~     including herpes labialis, many instances of viral re-activation occur without symptoms, and~     can only be identified by detection of virus on the lips of infected individuals. In these~     cases, the virus is cleared from the local site without the development of a classical~     ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly~     stops viral replication in the skin and also causes the development of the herpes lesion~     prodrome and a considerable part of the symptoms associated with a classical ulcerative~     herpes lesion. One could therefore predict that treatment with an antiviral drug alone would~     help the immune system in shortening the virus replication, but may not substantially reduce~     the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of~     using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related~     symptoms associated with the infection has been well established. We have found that a~     topical formulation of VDO is useful for alleviating pain and inflammation associated with~     infection caused by herpes virus.~   "
64897|NCT02207868|"~     The aim of the study is to document the left and right ventricular function in patients with~     sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results~     of this study should help to generate hypothesis for further future studies.~      The primary hypothesis is that the increased use of modern image guided methods could~     provide essential aspects for the follow up.~   "
64898|NCT02207855|"~     This a study to retrospectively review our experience with the use of chloroprocaine for~     postoperative epidural infusions in neonates and infants. Pain scores and the need for~     intravenous analgesic agents will be recorded from the records to demonstrate the efficacy~     of the technique.~   "
64899|NCT02207842|"~     One of the most common side effects of a surgical procedure is infection. In order to lower~     the number of infections that occur after surgery, it is important for physicians to know~     how medications used during surgery affect the way the body fights infection. Often, when~     anesthesiologists are helping people go to sleep before surgery they give people medications~     known as volatile anesthetics. Volatile anesthetics are medications that can change from a~     liquid or solid to a gas very easily. Some studies suggest that these types of medications~     may change the way white blood cells work in the body. Changing the way white blood cells~     work could possibly increase the person's risk of infection after their surgery or weaken~     their body's ability to fight infections. The goal of this research study is to learn about~     how volatile anesthesia medications change the way white blood cells work in people having~     anesthesia for cardiac procedures. To do this, investigators will examine the function of~     while blood cells in the laboratory based setting.~   "
64900|NCT02207829|"~     This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate~     the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]~     when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)~     administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in~     Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the~     run-in period, subjects who meet the randomization criteria will be randomized to receive~     UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via~     HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo~     administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an~     outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in~     period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28~     (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in~     Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and~     Day 168 (Visit 10). The total duration of subject participation in the study will be~     approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic~     visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects~     will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be~     obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits~     3 to 7.~      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.~   "
64901|NCT02207816|"~     The purpose of this study is to conduct long-term surveillance for efficacy, safety and~     immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria~     vaccine in infants and children in Africa following a primary vaccination series~     (NCT00866619). No new subjects will be enrolled in this extension study.~   "
64902|NCT02207803|"~     Traumatic brain injury (TBI) patients in Latin America experience high levels of disability~     and extremely poor functional outcomes, and their informal caregivers play a key role in~     their rehabilitation and care. To improve TBI rehabilitation through stronger informal~     caregiving, the proposed study will develop and evaluate an evidence--based and culturally~     sensitive Transition Assistance Program for informal caregivers of patients with TBI in~     Latin America during the patient's transition from hospital to home. This study will~     generate findings that can provide empirically supported guidance to clinicians regarding~     the provision of culturally tailored rehabilitation services for TBI caregivers in Latin~     America and in the U.S.~   "
64903|NCT02207790|"~     This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for~     E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK~     characteristics, the proposed study includes a cohort of white subjects treated for~     comparison with the cohort of Japanese subjects treated at the same dose. This comparison~     serves as a key PK bridge in assessing ethnic factors that may contribute to differences in~     plasma concentrations. Pharmacokinetic assessments in the proposed study will include~     confirmation of dose proportionality in Japanese subjects. This study will also evaluate~     safety and tolerability in Japanese subjects.~   "
65096|NCT02205281|"~     The purpose of this pilot study is to test the feasibility of an innovative, couples based~     approach to weight management during pregnancy. The primary hypothesis is that a~     couples-based behavioral weight management program will reduce the rate of gestational~     weight gain compared to standard care.~   "
64905|NCT02207764|"~     This research is being done to test whether a complementary intervention, Reiki therapy, can~     provide added benefits to the standard patient care. Reiki is method for stress reduction~     that uses hand positions over and/or on the body to help people relax.~      We are studying the effect of a 15-minute Reiki application compared to an intervention of~     nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and~     improving patient outcomes. In the future we would like to offer complementary interventions~     as an adjunct to our standard care for patients.~   "
64906|NCT02207751|"~     The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and~     the best way to collect data regarding their function in England, Wales and Northern~     Ireland.~      Phase 1: We will carry out a detailed examination of existing returned pilot data with~     emphasis on data fields with poor data completeness and perform root cause analysis, and~     assess deficiencies in data field definition to identify improvements to be implemented. We~     will construct and disseminate electronic survey material to all study centres with targeted~     visits by the Principle Investigator undertaken. These visits will facilitate insight into~     local organization of data collection including interaction with designated individuals~     responsible for data returns. PD training days will be organized with emphasis on clinical~     practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics~     will be linked to existing acquired PD patient information to ensure the accuracy of~     collected data. An online data acquisition system will be developed to allow direct data~     entry from centres.~      Phase 2: On-going and sustained data acquisition performed on a prospective basis.~      Phase 3: Primary data analysis including clinical practice variation in England, Wales and~     Northern Ireland to identify site specific PD catheter functionality variation.~     Additionally, patient and site specific characteristics that predict clinical outcomes in PD~     will be identified and characterised.~      Phase 4: Clinical guidelines will be developed.~   "
64907|NCT02207738|"~     Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar~     radiofrequency treatment for acne scar.~   "
64908|NCT02207725|"~     The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the~     anticoagulation effect of Apixaban.~   "
64909|NCT02207712|"~     In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis~     that preventing the dark adaptation and associated hypoxia of the rods in the eye could in~     turn prevent or halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO~     is a devastating disease that is the most common cause of registerable blindness in the~     working age-group in the United Kingdom (UK)~      This is a multi-centred randomised controlled trial involving 240 patients. Post~     randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at~     night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal~     (eye) ranibizumab. Those in the standard arm will receive their routine, prescribed~     ranibizumab treatment only.~      The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night~     reduces the number of intravitreal injections of ranibizumab required by patients undergoing~     such a course for the treatment of DMO.~   "
64910|NCT02207699|"~     The primary objective of this study is to determine the effects of benzonatate (200 mg and~     800 mg) on the QT interval following single dose oral administration at each time point~     post-dose.~   "
64911|NCT02207686|"~     The investigators aim to analyze tumors from vHL patients who have different courses of~     disease and different types of VHL gene alterations to characterize which types of genetic~     alterations the tumors contain and how these alterations affect the tumor cells' behavior on~     a molecular level. The investigators will then compare these observations to vHL disease~     outcome in patients and families.~      It is already known that most vHL tumors develop when both copies of the VHL gene in a cell~     are inactivated. The first copy is inactivated in all the person's cells from birth (first~     hit), leaving just one functional copy. A tumor can develop from cells where the second~     copy is also inactivated (second hit). So far, only the molecular consequences of the~     first hit have been investigated. It is our hypothesis that both the first and second hits~     in combination have consequences for tumor development and clinical outcome. The~     investigators will include tumors from patients with different disease courses and different~     types of first hits and analyse the tumors' DNA in order to find correlations between the~     first and second hits and patients' and families' medical histories. The investigators~     hereby hope to give new insights into how vHL tumors grow and which genetic factors~     influence tumor development. These results will contribute to the current knowledge of vHL~     and help us get one step closer to be able to predict an individual's tumor risks and need~     for surveillance.~   "
64912|NCT02207673|"~     Epilepsy occurs in 0.5-0.7% of the population, of which 25% are children. 30% Of patients~     with focal epilepsy do not respond well to medication and half of them are eligible for~     epilepsy surgery. In recent years, the importance of early epilepsy surgery has been~     stressed, as successful surgery may lead seizure and medication freedom and improved social~     and cognitive development, especially in children. The current success rate of epilepsy~     surgery is around 65%; During surgery intracranial electrocorticography (acute ECoG, aECoG)~     is recorded in some medical centers. The presence of epileptiform brian activity, spikes,~     identified by clinical neurophysiologists, is used to guide the neurosurgeon in the extent~     of the brain tissue that needs to be resected. Spikes are considered markers of the presence~     of epilepsy. High Frequency Oscillations (HFOs, >80-500Hz) in the ECoG have recently been~     identified as a new biomarker for epileptogenic tissue. Retrospective research shows that~     their local presence strongly relates to the seizure onset, and removal of tissue with HFOs~     could predict a better surgical outcome. The area showing HFOs usually overlaps with, but is~     smaller than the area with spikes, and HFOs do not tend to propagate to distant sites as~     spikes do. The identification of HFOs is more objective than of spikes and automatic~     detection software exists.~      A pilot study is performed to test the hypothesis : The intra-operative use of HFOs to~     delineate the epileptogenic cortex does not yield significantly worse outcome in seizure~     freedom than the current method based on spikes.~      Study design is a single blinded multi-center randomized controlled trial. In two Dutch~     centers, the VU medical center ( Amsterdam) and University Medical Center Utrecht.~      The study population (sample size 78) consists of patients of all ages with refractory~     epilepsy undergoing epilepsy surgery with aECoG to guide the extent of the resection.~      Eligible patients are randomised, after informed consent, into group 1 (HFOs) in whom a~     resection guided by HFOs in the aECoG (new), or into group 2 (spikes) in whom a resection is~     guided by epileptiform spikes in the aECoG (current standard). Ictiform spike patterns will~     always be resected.~      Main study endpoint is outcome after epilepsy surgery after 1 year of follow-up dichotomized~     in total seizure freedom (Engel Ia&b) vs. seizure recurrence (Engel Ic-IV).~   "
65106|NCT02205151|"~     An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics~     of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and~     Amlodipine as Individual Tablets in Healthy Male Volunteers~   "
64913|NCT02207660|"~     Objectives: To evaluate the effectiveness and toxicity of the combination of infusional~     cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly~     every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.~      Methods: The medical records of all patients with stage IVB, recurrent or metastatic~     cervical cancer who were treated with P-HDFL regimen between January 2005 and December 2009~     at National Taiwan University Hospital were reviewed.~      Expected results: Investigators will identify the effectiveness and toxicity of the~     combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus~     leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or~     metastatic carcinoma of cervix.~   "
64914|NCT02207647|"~     Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of~     a potentially infectious nature are among those of greatest concern. Routine clinical and~     laboratory evaluation of such patients involves screening for known infectious disease~     agents, selection of which is nonstandardized. Progress in diagnostic technologies,~     especially molecular techniques based on genetic characteristics of potential pathogens, has~     greatly expanded the investigators capacity to evaluate specimens from patients for a much~     wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of~     Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative~     agents for the approximately 50% of all such presentations which go un-diagnosed. The~     investigators propose a study involving a collaboration between the EMERGEncy ID NET, a~     network of 10 geographically diverse university-affiliated urban emergency departments~     (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and~     Prevention (CDC), to use these new technologies to address this issue.~   "
64915|NCT02207634|"~     This study evaluates change over time in neurocognitive testing in subjects receiving statin~     therapy in combination with evolocumab (AMG 145), compared with subjects receiving statin~     therapy in combination with placebo.~   "
64916|NCT02207621|"~     Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic~     Solution compared to Timolol Maleate Ophthalmic Solution~   "
64917|NCT02207608|"~     The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in~     reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial~     cell carcinoma.~   "
64918|NCT02207595|"~     The primary objective of this study is to investigate the safety and tolerability of~     UCB5857.~   "
64919|NCT02207582|"~     Transcranial random noise stimulation is used to stimulate the prefrontal cortices in~     patients with depression. It's a placebo-controlled two-arm study.~   "
64920|NCT02207569|"~     The study objectives are to assess the safety and efficacy of the CoreValve Evolut R~     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic~     aortic stenosis are considered at high or extreme risk for surgical aortic valve~     replacement.~   "
64921|NCT02207556|"~     In this study the investigators want to find out more about the addition of the antibiotic,~     doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators~     want to find out whether doxycycline improves the response to standard anti-amyloid therapy~     and whether it causes any problems (side effects).~   "
64922|NCT02207543|"~     The proposed work is part of a multidisciplinary approach to continuity of care in the~     particular context of the palliative phase of cancer. In conducting this study, we would~     like to characterize, at the regional level, satisfaction with the care of patients and~     their families in their care home situations palliative cancer. This evaluation will be~     based on questionnaires adapted versions in French language satisfaction questionnaires~     recently validated for patients in palliative situation and supported home care.~      It will also identify the challenges faced by both patients, caregivers attending~     physicians.~      The evaluation of these elements is a prerequisite to propose ways of improving at a~     hospital palliative care for output relay and anticipate the coordination of care for~     optimal care of the patient at home, to meet the expectations of different stakeholders, or~     even prevent certain readmissions avoidable.~   "
64923|NCT02207530|"~     Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR~   "
64924|NCT02207517|"~     CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages~     9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is~     to see if office-based therapy for convergence insufficiency (CI) improves reading ability~     and attention. CI is an eye-teaming problem where the eyes would like to drift outward when~     reading or doing close work. When eyes drift out, double vision can happen. To prevent~     double vision one must use extra effort to keep the eyes from going out. This extra effort~     can cause symptoms that can interfere with reading and working comfortably at near. These~     symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of~     place when reading or performing tasks at near. In a prior study we found that therapy~     improves these symptoms. In this study we are looking at whether the therapy improves~     reading and attention~   "
64925|NCT02207504|"~     This research study is comparing the combination of drugs Crizotinib and Enzalutamide as a~     possible treatment for metastatic castration-resistant prostate cancer (mCRPC).~   "
64926|NCT02207491|"~     To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324~     Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic~     Solution, 0.5%~   "
64927|NCT02207478|"~     The purpose of this study is to evaluate the efficacy and safety of electromagnetic~     navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral~     pulmonary lesions (PPLs) .~   "
64942|NCT02207283|"~     This study is intended to build on recent findings from our laboratory showing that a single~     dose of tadalafil (also known as Cialis) restored normal blood flow regulation in men with~     Becker muscular dystrophy. The investigators now wish to extend these findings by showing~     that the same dose of tadalafil will also prevent muscle injury and fatigue. Patients will~     take a single dose of tadalafil prior to exercising. Then doctors will measure whether the~     patients muscles receive more blood flow and are better protected during exercise.~   "
64943|NCT02207270|"~     The purpose of this study is to determine whether the total costs of care associated with~     uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through~     30-day follow up are lower among patients who are randomly assigned to same day discharge~     (SDD) or overnight hospital stay (ON).~   "
64928|NCT02207465|"~     The investigators hypothesize that intensification of local therapy will lead to~     improvements in local control and survival in patients with unresectable and borderline~     resectable pancreatic cancer. The investigators propose to do this by combining~     nab-paclitaxel concurrently with dose-escalated radiation therapy. In the first part of this~     phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation~     dose is held constant at a standardly accepted level. The use of this novel~     chemoradiotherapy regimen will take advantage of nab-paclitaxels specific anti-tumor and~     anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby~     improve local control. After the MTD of nab-paclitaxel had been determined, in the second~     part of this study (sub-trial 2), the investigators will administer nab-paclitaxel at the~     determined MTD concurrently with escalated doses of radiation. The investigators will~     utilize a combination of protons and IMRT to safely deliver high doses of radiation while~     maximally sparing surrounding normal tissue. Patients will also preferentially have 2-3~     fiducial markers placed in or around the tumor for daily localization and will be treated at~     breath hold in order to prevent tumor movement with normal respiration. Such a technique~     will help minimize target volumes and thereby avoid critical normal structures. The~     investigators will use gemcitabine and nab-paclitaxel before and after chemoradiotherapy~     given its promising results in metastatic pancreatic cancer patients. Correlative tissue and~     serum biomarkers are an important, but optional, part of this study.~   "
64929|NCT02207452|"~     This protocol describes the investigation of the use of hyperpolarised helium magnetic~     resonance imaging (MRI) in reflecting the regional differences in lung function of moderate~     to severe Chronic Obstructive Pulmonary Disease (COPD) patients.~      Since finalisation of the original protocol, new medications for COPD have received Market~     Authorisation Approvals. Protocol Amendment 02 has been prepared to include these~     medications in the protocol eligibility criteria and restrictions for the study.~   "
64930|NCT02207439|"~     This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease~     inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible~     patients will receive a lead-in period of Nelfinavir (1250 mg po bid) for 7-14 days prior~     to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based~     chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).~   "
64931|NCT02207426|"~     This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device~     with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of~     tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be~     determined.~   "
64932|NCT02207413|"~     The purpose of this trial is to demonstrate the acceptable safety profile and the~     immunological non-inferiority of the FLU D-QIV vaccine manufactured with this~     investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV~     manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).~   "
64933|NCT02207400|"~     This study will compare the Gingival Bleeding and Gingival Inflammation following twice~     daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium~     bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research,~     Inc. Participants will be recruited from their database and by use of an external~     recruitment agency~   "
64934|NCT02207387|"~     This study will investigate the effects of a contingency-based musical walking intervention~     program called Ambulosono on neural mechanisms in the brain. The investigators will~     investigate the long-term impact of Ambulosono on brain plasticity with functional MRI~     technique. Participants will undergo 3 months of Ambulosono training and their pre-training~     and post-training fMRI brain scans will be compared to understand the neural networks and~     brain mechanisms following this intervention. The investigators hypothesized that Ambulosono~     may induce functional compensatory reorganization of neural networks in the brain. This~     project will allow us to address the important potential confound of placebo influence and~     to aid in optimizing this intervention program. Additionally, the investigators are hoping~     to investigate the synergistic effects of rasagiline and exercise; the investigators'~     hypothesis is that there will be a positive synergistic effect, and that exercise will~     augment the effectiveness of rasagiline in treating Parkinson's symptoms.~   "
64935|NCT02207374|"~     This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy~     of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic~     drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on~     diet/exercise therapy or OAD monotherapy.~   "
64936|NCT02207361|"~     Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National~     Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is~     also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.~   "
64937|NCT02207348|"~     This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence~     between single-dose liraglutide administered subcutaneously with two different~     pen-injectors.~   "
64938|NCT02207335|"~     Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended~     scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination~     with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study~     with small sample.~   "
64939|NCT02207322|"~     The main purpose of this study is to assess whether early integration of palliative and~     supportive care services in care of patients hospitalized for hematopoietic stem cell~     transplantation (HSCT) can improve patients' and family caregivers' quality of life and~     mood.~   "
64940|NCT02207309|"~     This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients~     with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment~     including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional~     hyperthermia.~   "
64941|NCT02207296|"~     The purpose of this study is to determine whether an operative hemodynamic optimization~     using the plethysmographic variability index during orthopedic surgery could decrease the~     length of hospital stay and the postoperative morbidity.~   "
64944|NCT02207257|"~     This study will evaluate the establishment of anticoagulation (re-anticoagulation) of~     subjects with edoxaban following reversal by PER977 and will identify a dose regimen of~     PER977 that reverses the effects of edoxaban for up to 21 hours.~   "
64950|NCT02207179|"~     This study will evaluate LumaScan, an innovative polarization microscope for real time,~     intraoperative imaging and evaluation of the surface of excised tissue excised during Breast~     Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators~     hypothesis is that LumaScan will be comparable for cancer detection to conventional~     histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative~     images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision~     surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and~     loss of confidence in the tissue conservation surgery procedure.~   "
64951|NCT02207166|"~     Medical devices are designed and manufactured by subjective design process that was only~     based on engineers' direct concepts to essential principles sets for the device. A home user~     may not easily use or operate the piece of medical device through the interfacing components~     as the designer's expected such as the meaning when pushing a button or switching a knob,~     even the required procedure needed when a certain display shown to fulfill some knowledge~     dependent judgment. In addition, the incompatible interfacing designed communication between~     a user and the device may cause possible errors that may trigger further negative~     consequences during the use of the device to a innocent home user.~      The aim of this research is to closely understand the consequent results of human factor~     engineering or usability engineering practices of various types or models of marketed~     home-use blood pressure monitors (BPM) in real use.~   "
64952|NCT02207153|"~     Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death.~     The reasons for this excess cardiovascular mortality are only partly understood. Classical~     complicated artherosclerotic disease does not appear to be the primary cause of cardiac~     death in chronic dialysis patients. In fact, the predictive potential of classic~     cardiovascular risk factors such as hypertension, obesity and hyperlipidemia appears to be~     reduced in dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers~     to adequately reflect dialysis induced myocardial stunning, progressive cardiovascular~     disease, and the risk of death.~      To extend and corroborate these results, we are planning a large, prospective, observational~     study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its~     power calculation and hypotheses are based on our pilot studies~   "
64953|NCT02207140|"~     The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks.~     Following randomization, healthy elderly are randomized into two groups receiving probiotics~     or placebo. Fecal samples are collected before and after the study. The samples are~     investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as~     well changes in the fecal metabolome. The effects of the produced metabolites on~     mitochondrial activity will moreover be investigated using selected intestinal cell lines.~   "
64954|NCT02207127|"~     There is a fundamental gap in the investigators ability to design effective surgical~     treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate~     non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful~     outcome ranging from 5% to 65% for individual or combination procedures. To predict - and~     thereby to improve - outcomes, the investigators must determine what predicts surgical~     success. This project will compare findings from two evaluations: drug-induced sleep~     endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated~     important benefits, but it has important limitations. Upper airway MRI is the most complete~     evaluation performed during wakefulness, making it conducive to broad application and less~     expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The~     investigators propose a cross-sectional analysis of 40 adult subjects with moderate to~     severe OSA. In addition to history, physical examination, and polysomnogram (sleep study),~     all subjects will undergo DISE and MRI to characterize the pattern of obstruction. The~     investigators will examine the association between DISE and MRI, focusing on specific DISE~     findings that have been associated with surgical outcomes. The investigators~     multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,~     and upper airway MRI.~   "
64955|NCT02207114|"~     The proposed work will provide critical insights into the potential impact of a~     biomarker-based algorithm on reducing unnecessary antibiotic use in different adult and~     pediatric/neonatal ICU's. This proposal will also assess the costs (or savings) of a~     biomarker-based intervention. Overall, the results of this work will be critical in~     informing future strategies to eliminate unnecessary antibiotic use and curb the continued~     rise in antimicrobial resistance.~   "
64956|NCT02207101|"~     Young athletes are usually regarded as a special subgroup of healthy individuals with a~     unique lifestyle who are apparently invulnerable and often capable of extraordinary physical~     achievement. Most athletic disciplines to some extent combine endurance and strength modes~     of physical conditioning. Acute responses to endurance exercise training include substantial~     increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood~     pressure in-spite of this, high intensity chronic training such as marathons, very long~     distance bicycle racing etc., can lead to transient acute volume overload of the atria and~     right ventricle, with transient reductions in right ventricular ejection fraction and~     elevations of cardiac biomarkers. Although these biomarkers generally normalize back within~     seven to ten days, these transient changes may sooner or later mark the beginning of~     processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .~      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been~     no new advancements in finding an alternate option which can protect the cardio vascular~     system in the athletes.~      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in~     athletes along with improvising the endurance capacity, Enovate Biolife is in the process of~     development of an innovative product E-OJ-01.~      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes~     by enhancing ejection fraction which in turn improves cardiac output. This finally is~     hypothysed to increase the maximal oxygen uptake capacity in athletes.~   "
64957|NCT02207088|"~     This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week~     regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in~     HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,~     including those on hemodialysis or peritoneal dialysis.~   "
64958|NCT02207075|"~     This is pilot study designed to quantifying the innate immune inflammatory burden in a~     cohort of secondary progressive multiple sclerosis subjects. Innate immunity is recognized~     as a major cause of tissue injury in central nervous system (CNS) disease. Our hypothesis is~     that the innate immune response is heightened in SPMS as compared to healthy controls (HC's)~     and this activity increases over time and correlates with ongoing neuronal loss and~     disability. We will test this hypothesis by using highly specific molecular imaging~     techniques, specifically PET, in conjunction with high field MRI. We will utilize the PET~     radioligand [11C]PK11195 which will be used as a marker of activated macrophages/microglia.~     We will correlate [11C]PK11195 uptake with conventional measures of inflammation and~     neuronal integrity on high-resolution MRI.~      SPMS subjects will have two baseline [11C]PK-11195 PET scans (separated by 24 to 72 hours,~     test-retest) and subsequent scans at 6, 12 and 24 months. SPMS Subjects will have brain~     MRI's at baseline, 6, 12 and 24 months.~      Healthy Controls will have 2 baseline PET scans and one MRI.~   "
64959|NCT02207062|"~     This pilot clinical trial studies ibrutinib in treating patients with transformed indolent~     (a type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a~     period of improvement or do not respond to treatment. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes (proteins) needed for cell growth.~   "
64960|NCT02207049|"~     The purpose of this pilot study will be to examine the influence of providing snacks on~     consumption of overall energy intake in children aged 2-5 years in the Early Learning Center~     (ELC) at the University of Tennessee.~   "
64961|NCT02207036|"~     This randomized clinical trial will test the efficacy of a Facebook intervention based on~     the Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical~     Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).~   "
64962|NCT02207023|"~     The purpose of this study is to examine the efficacy of a lifestyle modification telehealth~     program on health-related behaviours in community-dwelling individuals living with stroke.~   "
64963|NCT02207010|"~     This study would test how much of the new drug, AZD1775, is present in tumor, blood, and~     skin after one dose of the drug.~      The purpose of the study is not to treat the tumor, but to see if the drug actually gets~     into the tumor cells. This study does not replace routine cancer treatment.~   "
64964|NCT02206997|"~     The aim of the study is to evaluate a patient prewarming concept following the~     recommendations of the S3-guideline Prevention of perioperative hypothermia with respect~     to incidence and complications of perioperative hypothermia. The study hypothesis is that~     postoperative core temperature in adult patients after prewarming is significantly higher~     than in patients who were treated following actual standard protocol (passive insulation).~   "
64965|NCT02206984|"~     RATIONALE: Currently, adjuvant endocrine therapy often follows a one-size-fits- all~     approach, with most premenopausal women receiving tamoxifen, and most postmenopausal~     receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive~     lobular carcinoma are treated no differently than patients with invasive ductal carcinoma~     based on the void of information specific to patients with this tumor type. Identification~     of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in~     ILC patients would have dramatic implications for the future management of this breast~     cancer subtype.~      PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in~     reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in~     expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve~     as a surrogate for outcome of ILC patients on endocrine therapy.~      Primary Objective:~      To determine the change from baseline to post-treatment Ki67 values in ER-positive,~     HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or~     further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine~     treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg~     given orally daily), or tamoxifen (20mg given orally daily).~   "
64966|NCT02206971|"~     The purpose of this study is to examine the impact of providing light smokers with feedback~     about their health, including exposure to tobacco-related chemicals.~   "
64967|NCT02206958|"~     Study Aim:~      To determine the feasibility and treatment effect of a multi-component intervention~     combining non-drug treatments for urinary incontinence, physical activity, and environmental~     modifications to prevent toileting disability in frail older women living in senior housing~     facilities.~      Hypothesis 1:~      Treatment group participants will have a 15% improvement in toileting skills as measured by~     the performance on timed toileting instrument compared to no improvement in women assigned~     to the no treatment group~      Hypothesis 2:~      Treatment group participants will have improvements in urinary incontinence severity and~     frequency, quality of life related to urinary incontinence, physical function, and barriers~     to toileting compared to no improvement in the no treatment group participants~   "
64968|NCT02206945|"~     The aim of this study is to train patients with obsessive-compulsive disorder to control a~     region of their brain that has been associated with their symptoms. Patients in the~     experimental group will be given direct feedback regarding activity in this brain area while~     they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to~     learn to control activity in the region during these feedback sessions. A separate group of~     patients will be given a control form of feedback that we do not believe can have clinical~     benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms~     more than the control feedback.~   "
64969|NCT02206932|"~     This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir~     and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.~   "
64982|NCT02206763|"~     This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of~     momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of~     momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor~     (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung~     cancer (NSCLC). Participants will be sequentially enrolled to receive progressively~     increasing doses of MMB in combination with erlotinib. Escalation of MMB doses will proceed~     to the MTD, defined as the highest tested dose associated with dose-limiting toxicities~     (DLT) during the first 28 days of combined erlotinib and MMB treatment. There will be four~     dose levels and each treatment cycle will consist of 28 days.~   "
64970|NCT02206919|"~     A major function of blood vessels is to control blood flow by dilating or constricting~     depending on the demand. Vascular dysfunction is a state in which blood vessels fail to~     carry out its normal roles such as regulating blood flow. Diabetes is a risk factor for~     vascular dysfunction. Dysfunction may involve the smaller and/or larger blood vessels.~     Failure in the ability of large (conduit) blood vessels to control blood flow may be an~     early feature of atherosclerosis, a leading cause of stroke and heart attack. Measures of~     blood vessel dilation give an indication of the health of the vessel. Ultrasound and MRI can~     assess vascular function by measuring changes in blood vessel dilation. Diabetes may also~     affect tiny vessels in the kidney. These vessels become porous allowing albumin (a protein~     in the blood) to leak into the urine. The investigators can easily measure the presence of~     albumin in the urine.~      This study aims to explore if MRI can demonstrate an association between vascular health in~     tiny and larger (conduit) blood vessels, by testing for an association between blood flow~     regulatory capacity of large vessels and presence of albumin in the urine.~   "
64971|NCT02206906|"~     Medication adherence is one of the most salient predictors of patient outcomes in the era~     following development of effective treatment for HIV infection. Evolving strategies to~     improve adherence, specifically incentive interventions and real-time medication monitoring,~     have shown some success in limited studies. Further investigation into incentive~     interventions for HIV-infected adolescents with poor medication adherence is necessary.~   "
64972|NCT02206893|"~     Introduction Chronic disease is prevalent and costly in the U.S. (Tu & Cohen, 2009). Poor~     eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, &~     Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health~     outcomes. However, its great potential has not been widely applied to people's eating~     behaviors and its impact is unknown.~      Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et~     al., 1999; Perri, Sears, & Clark, 1993). However, the former is usually delivered~     didactically or passively with limited use of smartphones. There is also little evidence of~     the effect of peer support delivered by smartphones in the domain of healthy eating. This~     research aims to study what smartphone technology can do to upgrade professional and peer~     supports, and to evaluate the impact of these mobile-app enabled supports on people's~     behavior of healthy eating and user engagement.~      Hypotheses~      According to Social Cognitive Theory, we hypothesize the following:~        1. Mobile-enabled self-monitoring approach improves users' healthy eating behaviors~          through improved self-efficacy~        2. Professional support improves users' healthy eating behaviors through improved~          self-efficacy~        3. Peer support improves users' healthy eating behaviors through improved self-efficacy~        4. The amount of support is positively correlated with the change in behaviors and their~          determinants~      Experiment Design The hypotheses will be examined bya 4-month randomized field experiment.~     375 subjects will be recruited and assigned to one of the five arms to receive the~     corresponding tool for diet management at no cost.~      Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer~     support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without~     any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are~     conducted at baseline and the end of each month. Respondents will be compensated by $8 and a~     chance to win $200 for each completed survey.~      Interventions~        1. All subjects receive the following interventions: an education package includes the~          importance of healthy eating, concept of MyPlate, personalized daily food plans;~          reminders throughout the study; goal setting capabilities;~        2. Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to~          record their food consumption which allows users to record their meals by images and~          doesn't require estimations in cups and ounces; daily reports and trend reports~        3. Self-monitoring provided by the web App: a traditional approach to record their food~          consumption which requires estimations in cups and ounces, and no images are allowed;~          no daily reports and trend reports are provided~        4. Professional support provided by a registered dietitian via the Android App: the~          supports include the following:~             1. Reply to users' messages regarding healthy eating~             2. Provide meal-specific comments on subjects' meal consumptions: one meal per week~             3. Provide feedback on the subjects' consumption patterns: once per week~        5. Peer support provided by other subjects via the Android App: the App provides platforms~          for subjects who have the same interest to communicate to each other. The actions the~          subjects can do in the platforms include:~             1. Post images or texts related to healthy eating~             2. Share meals with their ratings~             3. Like/dislike others' posts~             4. Comment on others' posts e Create groups which allow subjects who have the same~               interest to join~      Measurements~        1. Dependent Variables~             1. Eating behavior: a score of healthiness of a meal will be assigned by a dietitian.~               The scores obtained by the same subject along the experiment compose the subject's~               eating behavior~             2. Engaging behavior: this is measured by the number of meals recorded by the subject~               in a week. The numbers for the same subject along the experiment compose the~               subject's engaging behavior~        2. Independent Variables~             1. Level of peer support: this will be measured by a score representing the number of~               posts, likes, and comments received and given by a subject in a week~             2. Level of professional support: this will be measured by a score representing the~               number of messages or comments exchanged with the dietitian in a week~        3. Mediator Variables: self-efficacy, outcome expectation, and impediments will be~          measured by survey instruments~      Data~        1. User Survey: characteristics and perceptions~        2. Mobile App: time, location, and contents of goal setting, meal entries, communications~          with professionals and peers~        3. Web App: contents of goal setting and meal entries~      Analysis Confirmatory factor analysis and statistical modeling such as structural equation~     modeling and mixed models will be conducted to test our hypotheses.~   "
64973|NCT02206880|"~     Delirium is a prevalent complication following cardiac surgery that is under-recognized~     using current methods of delirium detection and that may be better identified through a~     systematic and standardized perioperative screening protocol.~      The purpose of this study is to determine the incidence of postoperative delirium in the~     current era of cardiac surgery using a validated delirium-screening tool.~   "
64974|NCT02206867|"~     To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those~     of Humira®.~   "
64975|NCT02206854|"~     For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study~     R-flurbiprofen, will be available as gelatine capsules.~      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine~     capsules. The serum availability will be determined by analysis of pharmakokinetic~     (pK)-blood samples at different time points. To assess the safety of the administered~     capsules adverse events will be documented.~      Analysis of lipid signaling molecules in plasma will be done to assess the role of this~     molecules as variable for therapeutic effects.~   "
64976|NCT02206841|"~     This study is designed for establishment of non-alcoholic fatty liver disease patients~     cohort to development of markers to predict histologic progression of liver fibrosis.~   "
64977|NCT02206828|"~     The aim of this Observational Registry Study is to assess the short- and long-term~     clinicaloutcomes following the use of Symbotex™ Composite Mesh in primary and incisional~     abdominal wall hernia surgeries by open or laparoscopic approach, according to the~     Instruction for use (IFU).~   "
64978|NCT02206815|"~     The aim of this study was to assess safety of antithrombotic drug ticagrelor plus oral~     anticoagulation adopted in persistent or permanent AF(Atrial fibrillation)~     patients（CHA2DS2VASc≥2） after PCI-S with specially regard to the occurrence of major~     bleeding complications. We hypothesized that baseline characteristics (ie age, anemia,~     previous major bleeding) and type of antithrombotic regimen could influence any bleeding~     events and the time of bleeding occurrence. We will test this hypothesis by comparing those~     AF patients who subsequently received double antithrombotic therapy (Ticagrelor + Warfarin)~     vs. triple antithrombotic therapy (Clopidogrel + Aspirin + Warfarin) after undergoing PCI-S.~   "
64979|NCT02206802|"~     The primary purpose of this study is to evaluate the clinical validity of the minoxidil~     response in-vitro diagnostic kit.~   "
64980|NCT02206789|"~     Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the~     efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk~     characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in~     preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials &~     Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom~     satisfactorily meet The inclusion criteria are different for each study Eligible candidates~     will be enrolled after signing an Informed Consent form Patients will be randomized into one~     of 2 groups~        -  Only on topical steroids group A~        -  On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized~          non-blinded study at a single centre. Methodology In both arms~           1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2~          weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1~          year is completed Systemic steroids may be administered in the initial 2 weeks at the~          discretion of the investigators. (For all patients with fungal keratitis topical~          steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until~          then voveran ophtha may be used~           3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day~          for 2years~           4. All patients will be followed for a minimum period of 2 years~           5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3~          months until 2 years are completed~           6. All episodes of graft rejection will be treated as per accepted norms and the~          patient will no longer follow the standardized protocol for steroid administration~   "
64981|NCT02206776|"~     Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and~     impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that~     are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3~     months), and even then they usually only partially reduce OCD symptoms. The present study,~     will test if intranasal ketamine is feasible to use and can reduce OCD symptoms~     significantly more than a comparison medication called midazolam. Therefore, you may or may~     not receive ketamine as part of this study. Results from this study will allow doctors and~     researchers to better understand if you and others with OCD may respond to this class of~     medications.~   "
64992|NCT02206633|"~     The study will aim to determine normal daily variation of the individual hydration level in~     longitudinal study on elderly in assisted living facility and assess a range of variation of~     individual hydration baselines for elderly in a normal physiologically hydrated state.~   "
64983|NCT02206750|"~     Purpose:~      The purpose of this protocol is to understand how social factors such as psychosocial stress~     may modify how people respond to air pollution. Ultimately this will help us understand~     health disparities from poor air quality.~      Participants:~      Up to 40 healthy adults,18-33 years old with different perception of stress will participate~     and complete this study.~      Procedures (methods):~      Subjects will be exposed to clean air and to ozone ( 300ppb) for 2 hours in a controlled~     environment chamber. Cardiac, vascular, pulmonary and cognitive function will be evaluated~     pre, immediately post and 18 hr post exposure.~      The primary endpoint will be Heart Rate Variability . Secondary endpoints will include~     pulmonary function, analysis of blood clotting/coagulation factors, biomarkers of stress,~     cognitive function, radial artery pulse wave measurements and analysis of soluble factors~     present in plasma.~   "
64984|NCT02206737|"~     Cigarette smoking is associated with poor wound healing and worse results after hand~     surgery. Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels~     in the hand.~      Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting~     smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a~     battery source. They are able to deliver vaporised nicotine in the absence of other~     ingredients found in normal cigarettes such as tar and carbon monoxide.~      Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine~     still has toxic effects on the body. Nicotine causes the release of chemicals within the~     body that act to reduce blood flow in small blood vessels of the hand.~      E-cigarettes remain a controversial topic among healthcare professionals due to the lack of~     research surrounding them. A recently published literature review identified only three~     significant studies into the effects of smoking e-cigarettes. All of these studies showed~     the harmful effects of e-cigarettes on the lungs but to date, there is no published research~     investigating the effects of e-cigarettes on the blood flow within the small blood vessels~     of the hand.~      Currently, we advise patients to quit smoking after they sustain a hand injury to improve~     healing and recent research suggests that patients should be advised to quit smoking 4 weeks~     before routine hand surgery. However, there is no guidance on whether we should also advice~     patients to refrain from using e-cigarettes for this time period.~      Our aims are to answer the following questions:~        1. Do electronic cigarettes have any effect on the blood flow in the hand?~        2. Do we need to give cessation advice to patients with hand injuries who smoke electronic~          cigarettes?~   "
64985|NCT02206724|"~     The investigators aim to test the safety and feasibility of prostate gland stereotactic body~     radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate~     cancer.~   "
64986|NCT02206711|"~     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and~     extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in~     healthy male subjects. There is no formal research hypothesis to be statistically tested for~     this study.~   "
64987|NCT02206698|"~     The submitted proposal is designed to reduce morbidity and mortality to injured children.~     Significant variability in the initial trauma assessment exists among institutions. The~     proposed project is a prospective, observational, multi-institutional study of children~     following blunt abdominal trauma. The specific goals of the project are to: 1) Document~     history, physical exam findings, imaging, and laboratory values, which are available to~     physicians during the initial trauma resuscitation prior to a decision on whether to order~     an abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and~     2) Derive and validate a multi-variable clinical prediction rule based on data variables~     readily available during the pediatric trauma resuscitation to identify patients at low risk~     for intra-abdominal injury, in which unnecessary CT might safely be avoided. Information~     from this study could be used to develop a more standardized approach to the evaluation for~     intra-abdominal injury following blunt trauma in children. This information could lead to~     significant improvement in the early recognition of injury and to improved resource~     utilization.~   "
64988|NCT02206685|"~     Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and~     can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle,~     which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior~     radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40~     degrees in the lumbar region) or when the curvature causes significant pain, or respiratory~     and cardiovascular restriction. Patient undergoing this surgical correction experience~     severe pain in the postoperative period and the management includes the use of opioid-based~     patient-controlled analgesia (PCA).~   "
64989|NCT02206672|"~     This prospective single-center study evaluates a current care procedure. It includes 14~     patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger~     criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their~     face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale~     0-48), a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth~     opening less than 55 millimeters. They should not have anticoagulant, anti-platelets~     aggregation medication or a daily steroid dose upper 20mg per day. Their BMI should exceed~     17.~      Micro fat grafting is a minimally invasive and usual procedure performed under local~     anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm~     diameter cannula from areas around the knees, the abdomen or the hips under a gentle~     aspiration. Lipoaspirated fat is then filtrated by the PureGraft system that offers a~     sterile, closed, single-use system, leading to a fast, consistent and controlled~     preparation. Then, 10 to 25 milliliters of this purified fat product is transferred through~     a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry~     points located around the mouth.~   "
64990|NCT02206659|"~     To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure~     monitoring in Chinese patients with mild to moderate essential hypertension~   "
64991|NCT02206646|"~     To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial~     infarction over a period of 6 years as required by Korean authorities, with the following~     observations:~        1. Unexpected adverse drug reactions~        2. Frequency and nature of adverse events (AEs)~        3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of~          Metalyse® was also assessed.~   "
64993|NCT02206620|"~     This study will compare the effects of placebo and donepezil, a drug that helps conserve~     concentrations of the neurotransmitter, acetylcholine on measures of balance and gait in~     subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled,~     cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a~     physiological index of cholinergic function will be measured to determine if the deficits in~     balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil~     as a measure of drug efficacy. Cognitive tests like the attention network test will be~     administered to determine if changes in gait and balance are mediated by changes in~     attention.~      The results of this study will be the most direct test of the hypothesized role of~     cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance.~     The study is exploratory because it is not known whether donepezil will affect gait, balance~     or attention, nor which measures of gait, balance or attention will be sensitive to drug~     manipulation. The study's immediate goal is to determine the potential utility of~     cholinergic manipulation as a strategy for preventing or treating balance and gait~     dysfunction in PD. The findings of this trial are intended to lead to more sharply focused~     questions about the role of cholinergic neurons in balance and gait and eventually to Phase~     II B trials to determine clinical utility of cholinergic manipulation to prevent falls and~     improve mobility.~   "
64994|NCT02206607|"~     Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three~     modified release formulations of PF-04937319 compared with the immediate release~     material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.~   "
64995|NCT02206594|"~     A pilot study designed to assess the feasibility of planned descemetorhexis for the~     treatment of Fuchs' corneal dystrophy.~   "
64996|NCT02206581|"~     The study will aim to evaluate the correlation between changes in ultrasound velocity and~     measures of hydration status including urine specific gravity, plasma and urine osmolality~     in male and female young adults after undergoing an acute dehydration and rehydration. The~     study will also test the hypothesis that body dehydration is a generalized physiological~     process equally affected all body muscles by comparing the data obtained on calf and biceps~     muscles.~   "
64997|NCT02206568|"~     To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).~   "
64998|NCT02206555|"~     Significant increases in HIV diagnoses among gay and other homosexually active men, in~     Australia and internationally, have been observed since the late 1990s. The levels of high~     HIV risk sexual practices among gay men have also increased, particularly unprotected anal~     intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed~     annually are among men who have sex with men (MSM). The proportion of heterosexual men and~     women among those diagnosed with HIV annually has also increased in recent years. Despite~     successes in some situations, HIV transmission has not been adequately reduced by the~     prevention methods available to those at risk, such as education, condoms, and treatment of~     sexually transmitted infections (STIs).~      The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis~     of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and~     homosexual men. Whether PrEP confers high rates of protection in real life situations and is~     a feasible strategy to implement still requires further investigation. Through its HIV~     prevention strategy 2015: New era, NSW Health committed to consider how to most~     appropriately and efficiently implement PrEP in line with evidence. This commitment~     translated in the support to this PrEP demonstration project.~      This demonstration project is designed to evaluate the off-label provision of daily~     combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA)~     as PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical~     settings in New South Wales. The project will inform policy development regarding primary~     HIV prevention with PrEP.~      This is an open-label, single-arm treatment evaluation study. All consenting and eligible~     HIV negative participants will receive TRUVADA prescribed for daily administration orally.~     At each followup visit, the following procedures will be conducted: clinical evaluations/~     procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal~     function, assessment for adherence to the prescribed medication, side effects, eligibility~     for next TRUVADA prescription, and willingness to continue on PrEP.~      As a study requirement, participants will be offered a self-administered assessment of~     behaviour, lifestyle and attitudes which will be conducted ideally within two and no more~     than seven days of the clinic visit in the participant's private space.~      Analyses will include: the feasibility of PrEP delivery, adherence to the study medication,~     safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of~     the risk of HIV seroconversion.~   "
64999|NCT02206542|"~     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly~     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively~     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and~     disability. These patients need early and regular rehabilitation to regain their function~     and prevent unnecessary complications such as contracture and disuse atrophy. Proper~     rehabilitation is important but the challenge is also great. However, rehabilitation~     training is a very labor-intensive task in which one to one treatment is essential and that~     will restrict the number of patients served. Moreover, patients receiving home programs are~     difficult to supervise, resulting in reduced training effect and delayed functional~     recovery. In order to reduce related cost (including time, personnel, facilities, and~     expense, etc.) of rehabilitation in hospitals or clinics, this Robot research team had~     developed a prototype of upper-limb exoskeleton rehabilitation robot and its related~     technology and human-robot interaction. This robot is used to serve the rehabilitation need~     of those patients suffering from upper extremities dysfunctions and also can provide careful~     designed therapeutic program of upper limbs including shoulder and elbow joint exercises.~     Its control software also provides a therapeutic management system with intelligence and~     ergonomic consideration. This work was funded by National Taiwan University Hospital (NTUH)~     since 2008 and has applied for both the U.S. and Taiwan (ROC) patents, where the latter has~     been approved in Nov. 2011. The clinical trial was firstly approved by Research Ethics~     Committee B of NTUH in 2009 and finally approved by Department of Health (DOH) in April~     2011. This team had completed the clinical trial for healthy subjects and pre-clinical trial~     for stroke patients. Based upon this experience an innovative and intelligent SMART Robot~     Rehabilitation System for Frozen Shoulder Syndrome is proposed to prove its safety,~     efficacy, and cost-effectiveness.~   "
65000|NCT02206529|"~     The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that~     will be integrated into a standard treatment program for childhood overweight. The~     investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its~     effectiveness compared with historical controls who received standard treatment. The~     historical controls will be participants in the FOCUS trial (Family Overweight: Comparing~     Use of Strategies; NCT00746629).~   "
65001|NCT02206516|"~     This study aims at combining imaging techniques and clinical evaluations to assess clinical~     change as well as brain changes that occur as a result of brain stimulation in adult~     attention deficit disorder.~   "
65002|NCT02206503|"~     This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose~     dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a~     biochemical progression, without CRAB, during Rd treatment.~   "
65003|NCT02206490|"~     Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments~     with FDA approved generic drugs are being administered to see if they help with the symptoms~     of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and~     thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are~     dextromethorphan and naltrexone.~   "
65004|NCT02206477|"~     Capsular contraction is the one of the most common complications of both esthetic and~     reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the~     contraction is unclear, but is believed to be similar to the formation of hypertrophic~     scarring.~      Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory,~     anti-proliferative, and antibacterial agent.~      The aim of this study is to test the effect of DMSO on the incidence and severity if~     capsular contracture after breast alloplastic reconstruction in irradiated patients.~      We conduct a prospective randomized-control single-surgeon study in the tertiary academic~     Rabin Medical Center.~      110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction~     will be included. They will be divided into two groups: the DMSO treatment group, which will~     be treated according to our protocol, and the control group, that will be treated with the~     same protocol but with 0.9% saline instead.~      Several measures will be taken, including: capsular contracture grading by two plastic~     surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography~     evaluation, and pathology examination of the capsule (biopsy will be taken during the second~     stage operation).~      Rates and grades of capsular contracture evident clinically, radiologically and~     pathologically, will be evaluated and compared.~   "
65005|NCT02206464|"~     Background:<TAB>~      - Flu virus that causes disease in birds can sometimes spread to people. It can cause severe~     illness, even death. Vaccines are used to try to create resistance to such infections.~     Researchers want to test a new vaccination strategy, combining two different vaccine types,~     the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if~     one of two combinations offer better protection against a certain type of bird flu in humans~     when compared to vaccination using two doses of MIV alone.~      Objectives:~        -  To see if 2 vaccines for bird flu, are safe and tolerable for humans.~        -  To study immune responses to these vaccines.~      Eligibility:~      - Healthy adults 18 60 years old.~      Design:~        -  Participants will be screened through a separate protocol.~        -  Participants will be randomly assigned to 1 of 3 groups. Each group will get a~          different combination of vaccines.~        -  Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be~          drawn at some visits. Urine samples may be collected.~        -  Participants will receive vaccinations at 2 of the visits, 16 weeks apart.~        -  The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA~          vaccine will be injected in the upper arm using a device that delivers the vaccine~          through the skin by pressure instead of a needle.~        -  Participants will be observed for at least 30 minutes after each vaccination.~        -  Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for~          evaluation, and complete a diary at home for 1 week. They will record their temperature~          and symptoms and look at the injection site daily.~        -  Participants will have follow-up blood tests.~   "
65006|NCT02206451|"~     Background:~      - Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs~     that are spread by mosquito bites. Researchers are creating vaccines that they hope will~     prevent malaria infection and/or the spread of it.~      Objective:~      - To test if the PfSPZ vaccine can stop malaria spread by mosquitoes.~      Eligibility:~      - People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be~     willing to have uninfected mosquitoes bite them.~      Design:~        -  Participants will be able to take part in this study at every visit after receiving all~          scheduled vaccinations.~        -  Participants will be asked whether they are willing to participate in the procedures.~          Female participants will have a pregnancy test.~        -  Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They~          will hold each cup to the participant s leg or arm so the mosquitoes can bite. These~          mosquitoes do not carry germs and will take about 3 drops of blood total.~        -  Participants will get a cream for any swelling or itching.~        -  Participants will be checked the next day for any discomfort.~        -  Participants may take part in this feeding test multiple times, if they are willing.~        -  If participants have malaria parasites in their blood, they may be asked to take part~          in another study. For this, they will sleep alone in their hut the night after the~          feeding test. A study team will set up nets to collect mosquitoes that may have bitten~          the participant overnight.~   "
65007|NCT02206438|"~     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these~     devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q~     (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that~     may optimise the airway sealing while reducing the potential for postoperative complications~     such as sore throat. The overall structure of the air-Q SP is identical to the original~     air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to~     compare the clinical performance of the classic LMA and the air-Q SP.~   "
65008|NCT02206425|"~     The goal of this clinical research study is to evaluate the safety and effectiveness (good~     and bad effects) of ixazomib given as part of a combination therapy to treat subjects with~     relapsed (subjects whose disease came back) or refractory (subjects whose disease did not~     respond to past treatment) multiple myeloma. More specifically, the study is focused on~     subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®)~     and showed worsening of their myeloma while receiving either one of these drugs in~     combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which~     means that ixazomib is currently being tested and is not yet approved by the United States~     Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple~     myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and~     carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current~     studies investigating ixazomib are demonstrating that it is as safe as bortezomib and~     effective for the treatment of multiple myeloma both on its own and in combination with~     other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone~     and melphalan.~   "
65032|NCT02206113|"~     A 16 week pilot study for Allina call center employees to look at the psychological outcomes~     and biological markers after an intervention of using a standing work station. There were~     two groups: group 1 received, and was instructed to use, the standing work station for all~     16 weeks, group 2 was a wait-list control group and received, and was instructed to use, the~     standing work station for the second 8 weeks. Psychological outcomes were measured at weeks~     0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.~   "
65009|NCT02206412|"~     High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and~     has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is~     released by inflammatory cells actively, or increased during cell death passively and~     mediates inflammatory response. It has been reported to have association with the prognosis~     after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis~     and heart failure. This study aimed to investigate the relationship of serum levels of HMGB1~     and post operative prognosis of patients who had undergone off-pump coronary artery bypass~     graft.~   "
65010|NCT02206399|"~     The investigators clinical trials will be for a medical device that is non-invasive in~     nature. The investigators will be studying whether their non-invasive medical device gets~     data that is as good as, or better than, an FDA previously approved, blood analysis device.~     There is no study hypothesis for this study.~   "
65011|NCT02206386|"~     To identify effective implementation strategies that can efficiently promote the use of~     evidence-based practices (EBP) across a large number of geographically dispersed,~     independent Home Health Agencies (HHAs). This study will use an agency-randomized design to~     test the effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of~     an evidence-based practice for geriatric depression by home healthcare agencies. The EBP is~     known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness~     of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH~     protocol with its depressed patients and changes in their patients' depressive symptoms over~     the episode of care.~   "
65012|NCT02206373|"~     Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there~     are many factors that may affect the measurement of serum creatinine, it is a well-accepted~     marker for renal function assessment. The creatinine clearance (ClCr) estimated by~     Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated~     glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in~     CKD staging. ClCr and eGFR not only have different units, but the results of estimation from~     the two varied among races and individuals. Since 2010, US Food and Drug Administration~     required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal~     insufficient patients during pharmacokinetic studies. Because most drugs are excreted~     through kidney, an understanding on the relationship between ClCr and eGFR is important to~     dose safely and effectively. Furthermore, identifying the factors that may influence the~     difference between ClCr and eGFR can provide in-depth consideration during clinical renal~     function assessment.~      Purpose： The purpose of this study is to analyze the correlation between different ClCr and~     eGFR equations in order to provide better renal dose. We also want to find the factors that~     may cause the differences between them.~      Methods： This study will conduct literature review to understand study population during the~     development of different ClCr and eGFR equations, as well as their scope of application.~     National Taiwan University Hospital electronic patient database will be used to analyze the~     correlation between ClCr and eGFR and to identify factors that may influence the difference~     between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine~     collection with calculated renal function will be used to verify the applicability of these~     equations (including a ClCr equation developed by our institute) in Taiwanese.~     Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal~     function while dosing a patient.~   "
65013|NCT02206360|"~     Early detection testing is recommended for individuals at elevated risk for the development~     of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal~     to or greater than five times the general population risk, or five times the average risk~     (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our~     inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the~     presence of hereditary cancer genes, as well as by family history. Enrolled subjects will~     undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every~     six to 12 months, for up to 5 years.~   "
65014|NCT02206347|"~     Postural-suprapostural task is defined as postural control takes place while at least one~     other concurrent task is being performed, and appropriate locus of attentional allocation is~     considered a critical factor for successful postural-suprapostural execution. Recent studies~     have indicated that the behavior performance of postural-suprapostural task would be~     affected by the prioritization of attentional allocation (postural-first vs.~     suprapostural-first); however, the inference of the appropriateness of attention~     prioritization is primarily limited to behavior observations and lacks direct neural~     evidences. How the effect of attentional priority between postural and suprapostural tasks~     on postural-suprapostural performance and its underlying cortical mechanism is rarely~     understood. By adopting postural-first and suprapostural-first strategies for~     postural-suprapostural task, the purpose of this 2-year research project is to 1)~     investigate the differences in performance quality and intrinsic neural mechanisms effect of~     a postural-suprapostural task for healthy adults with the analysis of event-related~     potential (ERP) and non-linear dynamics of behavior measures; 2) investigate brain plastic~     changes and the appropriateness of strategy use. In the first year, the attention~     prioritization effect on reciprocity of a postural-suprapostural task will be characterized~     by integrating the results of behavior performance and ERP causal connectivity with a~     special focus on validation of prevailing theoretical models. In the second year, the~     difference of task fluent for learning a postural-suprapostural task with~     postural-first/suprapostural-first strategy will be studied through the spatial and time~     variations in alpha rhythm after principle component analysis. The present project is~     expected to have significant contributions not only to gain a better insight to neural~     correlates of concurrent postural and motor suprapostural tasks, but to optimize treatment~     strategy for patients with balance or multi-tasking disturbances.~   "
65015|NCT02206334|"~     This phase I trial studies the side effects and the best dose of stereotactic body radiation~     therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate~     cancer that has spread to other parts of the body. Stereotactic body radiation therapy~     delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of~     cancer in the body while minimizing radiation exposure of surrounding normal tissue.~   "
65016|NCT02206321|"~     1. Prospective follow-up and comparative analysis of early, midterm, and long-term~          surgical results and complications between navigation assisted TKA and conventional~          TKA.~        2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from~          blood, tissues, and drainage between navigation assisted TKA and conventional TKA.~        3. Prospective follow-up of surgical results of navigation-assisted TKA.~   "
65017|NCT02206308|"~     The purpose of this study is to determine whether SCT400 is safe and effective in the~     treatment of B-cell Non Hodgkin's lymphoma~   "
65018|NCT02206295|"~     The primary aim of this study is to demonstrate bioequivalence in the rate and extent of~     absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets~     of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally~     as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects~     following a multiple-dose up-titration scheme.~   "
65019|NCT02206282|"~     A prospective clinical research is to assess the prevalence of implant rupture and presence~     of extracapsular gel in an un-referred population of women who have been implanted with the~     Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.~   "
65020|NCT02206269|"~     The objective of this Registry is to collect real-world outcome data for bronchial~     thermoplasty (BT) procedures in patients with severe persistent asthma who remain~     symptomatic despite taking standard of care maintenance medications.~   "
65021|NCT02206256|"~     Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method~     to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery~     are routinely pre-treated with a low calorie diet in order to reduce liver volume and to~     facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty~     acids has similar effects on liver volume, but a prospective comparison of both treatments~     has not been performed yet. Morbidly obese patients respond differently to surgical stress,~     due to a number of factors. First, obesity is associated with a low-grade inflammatory state~     induced by an increased amount of macrophages in adipose tissue. This state is associated~     with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune~     response to infections. Second, obesity is associated with an altered cortisol metabolism~     possibly related to adrenal insufficiency. This could play an important role in the altered~     response to surgical stress and postoperative complications in obese subjects. Third,~     obesity is associated with altered erythrocyte function, including decreased erythrocyte~     deformability and increased aggregation, factors contributing to an impaired~     microcirculation.~      This study has a number of different aims. First, we will compare pre-treatment with the~     standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for~     gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of~     omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the~     stress response of obese subjects before and erythrocyte function. Third, we will~     investigate the effect of gastric bypass surgery by comparing values before surgery with~     values on the first postoperative day and 6 months after surgery regarding to immunological~     parameters, stress response and erythrocyte function.~   "
65022|NCT02206243|"~     The purpose of this observational study is to evaluate the prostatic arterial embolization~     (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the~     treatment of symptomatic benign prostatic hyperplasia (BPH).~   "
65023|NCT02206230|"~     This study is being done to compare standard radiation therapy with hypofractionated~     radiation therapy for patients with newly diagnosed glioblastoma~   "
65024|NCT02206217|"~     The purpose of this study is to determine if the Multiple-Segment (MS) lens can slow myopia~     progression in Hong Kong schoolchildren.~   "
65025|NCT02206204|"~     This is a single-center, double-blind, randomized, placebo- and positive-controlled,~     double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over~     comparison between moxifloxacin and placebo in healthy male and female subjects. The primary~     objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an~     effect on cardiac repolarization exceeding the threshold of regulatory concern, at two~     orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female~     subjects. Moxifloxacin is included as a positive control.~   "
65026|NCT02206191|"~     In response to the high prevalence rates of childhood obesity in central Ohio, the Center~     for Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON);~     a partnership between primary care physicians and Nationwide Children's Hospital's Center~     for Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in~     Ohio. The overall goal of PCON is to bring an effective and user friendly obesity management~     program to the community physician's office to prevent and treat the growing number of obese~     children in the setting of the private office. The predominant nutrition messaging approach~     to tackling childhood obesity has revolved around the food choices and portion sizes. While~     this is relevant, an area with significant potential for impact for maintaining optimal~     growth and a healthy weight for young children is addressing feeding behaviors and~     self-regulation of intake;. - the how of eating. The investigators objective it to~     investigate whether this self-regulation approach can be employed for an older age group of~     6-11 years old.~   "
65027|NCT02206178|"~     Acetaminophen is one of the most widely used analgesic in the world, recommended for the~     symptomatic treatment of fever and pain.~      The purpose of this study is to assess the effectiveness of acetaminophen in association~     with N-acetylcysteine.~      The objective of this study is to evaluate if the association in healthy volunteers of~     acetaminophen and N-acétylcystéine~        1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control~        2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH~          enzyme.~   "
65028|NCT02206165|"~     The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine~     combined or alone and select better dose of CKD-330 in essential hypertension patients.~   "
65029|NCT02206152|"~     This is a single center, double blind randomized cross over design trial that will compare~     the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental~     hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18~     participants will be studied twice, 8 weeks apart. On each occasion they will undergo a 2~     hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and~     then again on the morning of day 2 and day 3. During the morning clamps, samples will be~     collected for later measurement of serum epinephrine levels, plasma and red blood cell NAC,~     cysteine, and glutathione concentrations and GSH/GSSG ratios (redox status), and~     participants will be asked to complete a hypoglycemia symptom questionnaire~   "
65030|NCT02206139|"~     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article~     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by~     work-related stress. A broadly applicable description defines burnout as a state of mental~     and physical exhaustion related to work or care giving activities. A long-standing~     conceptual and operational definition characterized burnout as a triad of emotional~     exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous,~     and detached responses to others), and reduced personal accomplishment (feelings of~     competence and achievement in one's work) In the World Health Organization International~     Classification of Diseases, 10th revision, burnout is defined as a state of vital~     exhaustion. Although no specific diagnosis of burnout is mentioned in the Diagnostic and~     Statistical Manual of Mental Disorders, burnout is a clear syndrome with significant~     consequences.~      Burnout in health care professionals has gained significant attention over the last several~     years. Given the intense emotional demands of the work environment, clinicians are~     particularly susceptible to developing burnout above and beyond usual workplace stress.~     Residency training, in particular, can cause a significant degree of burnout, leading to~     interference with individuals' ability to establish rapport, sort through diagnostic~     dilemmas, and work though complex treatment decision making. Overall, burnout is associated~     with a variety of negative consequences including depression, risk of medical errors, and~     negative effects on patient safety. The goal of this review is to provide medical educators~     and leaders with an overview of the existing factors that contribute to burnout, the impact~     of burnout, inter specialty variation, and suggestions for interventions to decrease~     burnout.~   "
65031|NCT02206126|"~     The purpose of this study is to evaluate the effects of moderate energy restriction on the~     body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,~     inflammatory biomarkers, metabolic profile and endothelial function in obese patients with~     OSA.~   "
65033|NCT02206100|"~     PER977 administration following a single subcutaneous (sc) dose of enoxaparin 1.5 mg/kg will~     have an acceptable safety and tolerability profile with no impact on pro-coagulant~     biomarkers.~   "
65767|NCT02196506|"~     The purpose of this study is to assess the tolerability, safety, and efficacy of~     brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD~     with and without anxious distress~   "
65034|NCT02206087|"~     Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with~     dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of~     PER977 followed by a one-week washout and then will receive unfractionated heparin followed~     by a single dose of PER977. The study will provide some insight into the doses that may be~     required to reverse anticoagulation induced by heparin. PER977 administration following~     heparin sodium injection will have an acceptable safety and tolerability profile with no~     impact on pro-coagulant biomarkers.~   "
65035|NCT02206074|"~     The investigators are conducting a research study to see if increasing the amount of nitrate~     (a substance found in large quantities in certain vegetables) in the diet can increase the~     ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D~     find exercise more uncomfortable than individuals who do not have T2D. This may be explained~     by the experimental studies showing that T2D can result in reductions in the supply of~     oxygen to the muscles. Studies have also shown that for a given level of activity,~     individuals with T2D will be much closer to their maximum exercise capacity than healthy~     individuals. Dietary nitrate may have two important beneficial effects in individuals with~     T2D: 1) The effects of dietary nitrate on the responses to exercise may have a significant~     impact on the ability of individuals with Type 2 diabetes to perform daily tasks and~     exercise more comfortably and 2) experimental studies suggest that increased nitrate~     consumption has been shown to reduce the amount of oxygen required for a given level of~     exercise.~      The investigators will recruit 60 individuals with T2D. These people will take part in a~     randomised crossover design study where they will be asked to drink normal beetroot juice~     (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different~     walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).~     This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen~     required for a given level of exercise in individuals with T2D. To test brain function~     individuals will be asked to perform a standard computerised decision making task following~     consumption of the nitrate rich and nitrate depleted juices.~   "
65036|NCT02206061|"~     The goal of this study is to evaluate the widespread implementation of a developmentally~     appropriate preventive asthma care intervention for urban teens. The School Based Asthma~     Care for Teens (SB-ACT) program includes two core components: 1) a trial of directly~     observed therapy (DOT) to allow the teen to experience the potential benefits from adhering~     to guideline-based asthma treatment, and 2) a developmentally appropriate Motivational~     Interviewing (MI) Counseling Intervention to help the teen transition to independent~     long-term medication adherence. The investigators hypothesize that teens receiving the~     SB-ACT program will 1) experience less asthma-related morbidity than an asthma education~     (AE) attention-control comparison group, and 2) have improved adherence, less urgent~     healthcare use, less absenteeism, improved quality of life, and reduced FeNO compared to AE.~     The investigators also hypothesize that participants receiving DOT-only will have improved~     asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but~     will not have sustained, clinically significant improvement in outcomes once the DOT phase~     is complete. This represents a unique opportunity to build upon existing community~     relationships with an innovative and developmentally focused program to improve asthma~     outcomes for urban teens.~   "
65037|NCT02206048|"~     The goal of this clinical research study is to learn if it is possible to get~     high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive~     carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images~     can show the difference between cancerous tissue and normal cervical tissue.~   "
65038|NCT02206035|"~     This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in~     preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial~     will be compared to those of contemporary controls from the CIBMTR.~   "
65039|NCT02206022|"~     At present, there is no reference protocol for Central Venous Catheter (CVC) insertion~     assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and~     anesthesia to realize this gesture, from single local anesthesia to general anesthesia.~     Remifentanil has been shown to decrease pain scores for insertion and removal of long-term~     central venous access. Remifentanil is also often employed for pediatric or labor analgesia~     for short acts as procedural sedation.~   "
65040|NCT02206009|"~     Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?~   "
65041|NCT02205996|"~     Strict glycaemic control has been associated with increased hypoglycaemia and mortality~     rate, the cause of which was unclear, in subjects with type 2 diabetes. In this study, we~     hypothesised that acute hypoglycaemia will result in platelet activation in people with type~     2 diabetes to a higher degree than controls.~   "
65042|NCT02205983|"~     In this study, the investigators will examine the effects of buprenorphine, as compared to~     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task~     and a non-stressful control task in healthy adults. There is strong evidence in support of~     the role of endogenous opioids and opiates in mediating social behavior in humans and other~     animals, and particularly, in social distress. The investigators have recently shown that~     buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the~     investigators propose to further explore the role of the opioid system in mediating stress~     responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition~     to buprenorphine. The investigators hypothesize that like buprenorphine, hydromorphone will~     reduce both physiological and subjective measures of stress.~   "
65043|NCT02205970|"~     The present study aims to verify the analgesic potential of a new methodological proposal~     for application for transcutaneous electrical nerve stimulation (TENS interactive) using~     patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind~     study with convenience sample.~   "
65044|NCT02205957|"~     Opinion survey to assess the level of satisfaction and the expectations of the residents in~     anesthesiology and intensive care in Tunisia ( North Africa)~   "
65045|NCT02205944|"~     The purpose of this research study is to determine whether two different types of forearm~     exercise, performed before fistula creation surgery, can improve surgery success and fistula~     maturation.~   "
72325|NCT02110693|"~     The purpose of the study is to develop and validate a questionnaire to screen and assess~     adult primary care patients for tobacco, alcohol, prescription drug, and drug use and~     problems related to their use.~   "
65046|NCT02205931|"~     Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the~     most common chronic neurological disorder in children. Epilepsy onset is most common in the~     first two years of life and is associated with poor prognosis for seizure control and~     neurodevelopmental outcome.~      The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in~     carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in~     children with epilepsy older than two. Associated benefits include: a reduced requirement~     for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital~     admissions. Although reports suggest that KD therapy improves seizures in younger children~     there is no high quality trial data that demonstrates effectiveness and safety in this age~     group. The KD is resource intensive, requiring dietetic and physician time; data is required~     to justify expansion of services to cater for the apparent need.~      The investigators therefore propose a prospective multicentre randomised trial to~     investigate the effectiveness and safety of the KD in children with epilepsy under the age~     of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to~     either receive the KD or further AEDs. The allocated treatment will be started after a 2week~     baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used~     to record seizures and related events, a questionnaire will be used to assess diet~     tolerance; also growth and blood biochemistry will be monitored.~      The information obtained from this study is necessary to optimise choices in epilepsy~     treatment, aiming to improve outcomes and thus determine whether and when the KD should~     should be used.~   "
65047|NCT02205918|"~     The purpose of this study is to examine how the brain and environment interact to influence~     children's ability to suppress tics using a medical technology called Transcranial Magnetic~     Stimulation (TMS).~   "
65048|NCT02205905|"~     This is an open-label, single-dose, non-randomized study in healthy male subjects to~     characterize the mass balance, metabolic disposition, and identification of the metabolites~     and general metabolic pathways following administration of a single dose of IV solution~     containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.~   "
65049|NCT02205892|"~     Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of~     inflammatory and non-inflammatory acne lesions in split face fashion~   "
65050|NCT02205879|"~     The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking~     and reducing drinking severity~   "
65051|NCT02205866|"~     This study evaluates the incidence of Non Receptive endometrium in obese infertile women~     compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,~     containing 238 genes, identifying the receptivity status of an endometrial sample and~     diagnosing the patient's Window of Implantation, regardless of the histological appearance~     of the sample. An endometrial biopsy is collected from the uterine fundus, either in a~     natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.~   "
65052|NCT02205853|"~     The aim of this study is to develop and identify the most effective strategy to implement~     PCRPs into daily care. We want to assess the added value of a multi-faceted strategy~     compared with a single-faceted patient-directed strategy.~   "
65053|NCT02205840|"~     The purpose of this study is to assess the safety and effectiveness of SI-614 solution~     compared with placebo solution in treating patients with dry eye.~   "
65054|NCT02205827|"~     The purpose of the study is to characterize the distribution and sources of variability in~     whole blood clotting time (WBCT) measurements in human blood collected from healthy~     volunteers by 5 different technicians.~   "
65055|NCT02205814|"~     This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm,~     dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy,~     safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of~     fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.~      Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a~     clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a~     total of 4 treatment arms. Each arm includes a single intra-articular injection of one of~     three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation~     ratio will be 1:1:1:1.~      The primary efficacy variable will be the change of the Western Ontario and McMaster~     Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from~     baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse~     events and clinical laboratory tests; local tolerability at the injection site will also be~     assessed. In addition, the population pharmacokinetics and the exposure-response~     relationship will be evaluated.~      The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7~     planned visits at site, including screening, randomisation, 4 follow-up visits and the End~     of study visit.~   "
65056|NCT02205801|"~     We aim to study the effect of local anesthetic when used in conjunction with general~     anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent~     pain control between bilateral superficial cervical plexus block and local wound~     infiltration when used in conjunction with a general anesthetic.~   "
65057|NCT02205788|"~     The purpose of this study is to determine if you can use an assay on tumor samples to see~     different patterns in response to the same chemotherapy treatment.~   "
65058|NCT02205775|"~     Myocardial necrosis is relatively frequent after percutaneous coronary intervention and is~     associated with higher mortality during the follow-up.~      Since anti-inflammatory properties of statins have been demonstrated and the benefit of~     statins in acute coronary syndromes have been proven, this study aims at testing the~     hypothesis that the pre-procedural intensive statin treatment reduce the extent of~     peri-procedural necrosis.~   "
65059|NCT02205762|"~     The LCH-IV is an international, multicenter, prospective clinical study for pediatric~     Langerhans Cell Histiocytosis LCH (age < 18 years).~   "
65090|NCT02205359|"~     The purpose of this clinical study is to test the hypothesis that market released Cardiac~     Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have~     a superior outcome compared to standard CRT devices in CRT indicated patients with normal~     atrio-ventricular (AV) conduction and left bundle branch block (LBBB).~   "
65060|NCT02205749|"~     Research with stored biospecimens can provide substantial societal benefits, including~     greater understanding of cancer etiology and discovery of new cancer therapies, but one~     critical social and ethical issue is the use of samples for research unplanned at the time~     of biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out,~     broad consent, study-specific consent) have been proposed for secondary research use of~     biospecimens, but empirical data on individuals' preferences for different consent models~     are limited, particularly from those with limited health literacy and from racial and ethnic~     minority groups. It is critically important to understand the consent preferences of diverse~     individuals, as participation of all population subgroups in biobanks is essential to reach~     translational cancer research goals. Based on a social ecological conceptual framework, the~     investigators will examine preferences for consent models for secondary research uses of~     biospecimens among a racially and socioeconomically diverse sample of women 35 years of age~     and older. The investigators aim to compare experimentally the effect of consent model on~     intentions to donate biospecimens for future research use among a diverse sample of women.~     The investigators hypothesize that women will have stronger intentions to donate based on~     the broad model of consent and the study-specific model of consent compared with the notice~     model of consent. These findings from groups underrepresented in research will be critical~     since the participation of these groups in biobanks is essential to generating findings that~     will achieve translational research goals of eliminating cancer disparities.~   "
65061|NCT02205736|"~     Subjects will be recruited from the participants in the Union and Mecklenburg County Living~     Room Visits. Participants in the Living Room Visit will have been recruited using community~     event flyers. During the Living Room Visits, the Health Educator will provide a general~     overview of the study. Individuals who are interested in participating in the study will~     then be generally screened for eligibility by the Protocol Coordinator who will then proceed~     to provide informed consent to potential subjects.~   "
65062|NCT02205723|"~     The objective of this protocol is to pilot an innovative approach to medication adherence to~     determine if such an approach will improve inhaled corticosteroid (ICS) medication~     adherence, a critical gap in improving the health of children with asthma. SNAPP~     incorporates monitoring, reminders, and dynamic feedback through a smartphone that will~     improve ICS medication adherence and that the investigators believe will influence the~     child's future independence and chronic disease-management skills.~   "
65063|NCT02205710|"~     Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate~     cognitive function in older adults and individuals with dementia. In recent years, such~     training has become particularly appealing in the clinical context, with many paradigms~     aimed specifically at adults experiencing various stages of cognitive decline due to Mild~     Cognitive Impairment, Alzheimer's disease, and vascular dementias. However, basic questions~     remain. For example, uncertainty persists regarding factors that influence observed~     improvements as well as the conditions that would maximize transfer and sustainability of~     training effects. The objective of this study is to evaluate factors that may maximize the~     benefits of computerized cognitive training in older adults.~   "
65064|NCT02205697|"~     Diet quality has been associated with a variety of chronic diseases including obesity. One~     measure that has been studied as an indicator for diet quality is fruit and vegetable~     intake. Although the US government has suggested that American's increase their intake of~     fruit and vegetables, epidemiological data suggest that most Americans have not been~     successful doing do, with the strongest disparity seen in people of low socioeconomic status~     (SES). This disparity in fruit and vegetable intake is thought to be the result of both~     individual and environmental factors that influence this health behavior. To help decrease~     the disparate rise in incidence of chronic disease in people of low SES, effective,~     cost-efficient and easy to implement interventions to improve fruit and vegetable intake and~     diet quality are needed.~      Theoretical models of health behavior change have been successfully used in research~     targeting individual factors associated with health behaviors. One theory, the Theory of~     Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)~     have been shown to be effective to increase fruit and vegetable intake in (mostly) white~     adults of average socioeconomic status. It is not know whether an implementation intention~     intervention to increase fruit and vegetable intake would be effective in women who are of~     low socioeconomic status. The primary aim of this research is to study (using quantitative~     and qualitative analysis) an implementation intention intervention to produce a positive~     change in fruit and vegetable intake. We theorize that the setting of an implementation~     intention in this group will be effective, cost-effective, and easy to implement~     intervention to promote an increase in fruit and vegetable intake.~   "
65065|NCT02205684|"~     Physical health problems are common in schizophrenia with a two- to three-fold increased~     morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A~     genetic vulnerability for developing cardiovascular disease has been documented in these~     patients, and many lifestyle factors also negatively influence physical health. Patients~     with schizophrenia are likely to smoke, are physically inactive and overweight, suffer from~     malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover,~     these patients have increased risk of developing diabetes mellitus type II and metabolic~     syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients~     with schizophrenia and underline the need for addressing their physical health.~      Poor physical fitness seems to be associated with exacerbated negative symptoms and~     increased cognitive dysfunction in patients with schizophrenia. However, evidence on~     physical activity and its consequences in schizophrenia is scarce. In this randomized~     controlled trial we investigate the effects of high intensity training in outpatients with~     schizophrenia on psychotic symptoms and well-being, cognition and cortical structure,~     tobacco smoking and substance use, in addition to metabolic indices.~   "
65066|NCT02205671|"~     The program consists of a 6-week small-group workshop for caregivers of people with memory~     problems.~      The goal of the study is to evaluate in a one year longitudinal study, program effectiveness~     in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving~     sleep, healthful behaviors and self-efficacy~   "
65091|NCT02205346|"~     Investigate urinary leukotriene E4 levels and determine if there is a correlation with~     severity of obstructive sleep apnea. The investigators then would like to determine a~     threshold level which could then be used for confirmation of diagnosis of obstructive sleep~     apnea (OSA).~   "
65067|NCT02205658|"~     The purpose of this study is to establish normative data for the Adult/Adolescent Sensory~     History (ASH) and to determine if the ASH is able to discriminate between individuals aged~     13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory~     processing Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who~     are typically functioning.~      It is anticipated that individuals with ASD will have the most problems with sensory~     processing, those with SPD will also have problems in comparison to typical individuals. It~     is also hypothesized that the measure will be able to discriminate between the three groups.~   "
65068|NCT02205645|"~     Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold~   "
65069|NCT02205632|"~     Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the~     macular area.~      Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be~     evaluated by its optical density.~      Reduced macular pigment level is a significant risk factor for age-macular degeneration. The~     nutritional intake can minimise the risk of age-macular degeneration.~   "
65070|NCT02205619|"~     The purpose of this study was to evaluate the residual cementum with the histological~     measurements and root surface topography with SEM evaluation using four periodontal~     treatment methods.~   "
65071|NCT02205606|"~     The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with~     primary hypercholesterolemia.~   "
65072|NCT02205593|"~     'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with~     psoriasis or atopic dermatitis. A range of support activities will be offered in order to~     learn effective self-management strategies and attitude to one's chronic skin disease and~     consequently improving quality of life.~   "
65073|NCT02205580|"~     Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and~     sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in~     children. There are few reports about its use for postoperative analgesia by continuous~     intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or~     vomiting.~      The investigators design this protocol to test efficacy of analgesia of three different~     rates of continuous intravenous sufentanil infusion for postoperative pain management~     following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also~     compare incidence rate of complications for three groups.~   "
65074|NCT02205567|"~     Bergamot-derived products have shown significant effects on plasma lipids. We aim in the~     present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.~   "
65075|NCT02205554|"~     The purpose of this study is to compare the safety, pharmacokinetic properties (the~     absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets),~     Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.~   "
65076|NCT02205541|"~     The investigators aim to perform the first controlled randomized prospective study using ECZ~     in pediatric STEC-HUS. This is of great interest as there is still no efficient specific~     therapy in that potentially devastating disease.~      Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial,~     reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the~     need for prospective studies.~   "
65077|NCT02205528|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC)~     injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with~     T2D.~   "
65078|NCT02205515|"~     Approximately 50% of patients with neuroendocrine cancers present with metastasis, a vast~     majority to the liver. In such patients, one treatment option for liver-directed therapy is~     surgical resection. However, a significant proportion of patients are not eligible for~     resection because of patient factors (age, comorbidities) or tumor-related factors.~      There have been scant data on the utility of EBRT (external-beam radiotherapy) and SABR~     (stereotactic ablative radiotherapy) for metastatic neuroendocrine tumors of the liver. This~     study will measure the effects of concurrent everolimus with external-beam radiotherapy to~     the liver for metastatic neuroendocrine New methods of tumor assessment are needed in NETs.~     Three new techniques are being developed at the Sunnybrook Research Institute to assess~     tumour response to treatment: (1) contrast enhanced ultrasound; (2) perfusion CT; and (3)~     perfusion MRI. These methods are devised to measure tumour perfusion and blood flow as~     response indicators and can measure cell death non-invasively.~        1. Concurrent everolimus given with external-beam radiotherapy to the liver for metastatic~          neuroendocrine tumors of the liver will enhance the efficacy of radiotherapy and add~          little, if any, toxicity~        2. New radiological measures of CEUS and DCE-CT are effective measure to delineate tumor~          response in NETs.~   "
65079|NCT02205502|"~     Ketamine seems an obvious choice in the setting of an emergency department in laceration~     repair.~      Lidocaine is the local anesthetics widespread used.~      Ketamine leads to dissociative amnesia.~      Theoretically , lidocaine is not useful in laceration repair using ketamine.~      However, lidocaine is used with ketamine in many emergency department.~      The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in~     children undergoing primary closure~   "
65080|NCT02205489|"~     Primary Objective:~      To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS~     patients who will be medicated according to specified algorithm designed to manage infusion~     associated reactions.~   "
65081|NCT02205476|"~     Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety~     and long-term efficacy of PF-06473871 one year after surgical revision and treatment with~     PF-06473871.~   "
65082|NCT02205463|"~     This dose-escalation study is to determine the safety, maximum tolerated dose (MTD) and~     efficacy of KD019 in combination with trastuzumab and mFOLFOX-6.~   "
65092|NCT02205333|"~     The main purpose of this study is to determine the best dose of MEDI6469 that is safe and~     tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736, or~     rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma~     (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with~     advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL.~     MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.~   "
65083|NCT02205450|"~     The PWS is a genetic disease with intellectual disabilities associated with multiple~     manifestations in other body systems. It is characterized by hypothalamic-pituitary~     abnormalities with severe hypotonia during the early years of life, conditioning feeding~     difficulties. Hyperphagia appears later, causing severe obesity in pre - school ages. Other~     endocrine abnormalities associated produce short stature, GH deficiency and hypogonadotropic~     hypogonadism. These patients also have varying cognitive dysfunction associated as well as~     learning problems, compounded by the development of psychological-psychiatric and behavioral~     problems language. The aetiology of GH decreased secretion of the SPW is controversial, it~     is known that IGF -1 levels are reduced in children and adults with PWS. The rational use of~     GH is derived from knowledge of comorbidities observed in PWS, which seem to be related to~     GH deficiency: hypotonia, altered body composition, decreased growth, even obesity.~      • The GH is accepted since 2000 for the treatment of PWS. Following fatal episodes in our~     country, it was decided to start treatment at 2 years of age in an arbitrary manner, but not~     in the U.S. or France. Subsequent studies have found that GH per se is not a risk factor for~     mortality. The currently published data supporting the benefits of GH treatment when started~     between 4 and 6 months of life, even some experts advocate starting at 3 months, but due to~     the lack of consensus on the age of onset treatment, despite the benefits of your home at an~     early age before the onset of obesity often starts around 2 years of life.~      HYPOTHESIS The use of GH is safe and effective in patients with PWS children under 2 years~     old.~   "
65084|NCT02205437|"~     Schizophrenia is a severe and chronic mental disorder. The lifetime risk of schizophrenia is~     around 1%. Its course is chronic and frequently disabling. The keystone of schizophrenia~     treatment is antipsychotic medications. The use of antipsychotics represents a huge public~     health and economic burden to society. Most of antipsychotics drugs are metoo drugs,~     directly or indirectly replicating dopamine D2 receptor blockade. Pharmaceutical companies~     have aimed to produce drugs with a general indication for all patients with schizophrenia~     with a one-size-fits-all strategy with no targeting or stratification. Second generation~     antipsychotics partly improve positive symptoms and are quite often associated to weight~     gain, metabolic changes and increased risk of cardiovascular diseases. Antipsychotics only~     achieve a certain degree of clinical improvement in a percentage of patients (45%) and 30%~     of the patients are treatment resistant. In light of the current deadlock, there is an~     urgent need to expand the horizon of pharmacological research by elucidating new mechanisms~     related to antipsychotic actions. An alternative strategy is the comparison of gene~     expression profiles in drug-naive accurately ill patients before and after antipsychotic~     treatment has been initiated. Our research group has a great experience in the field and has~     been working on this hypothesis in the latest years. We propose a continuation project to~     thoroughly explore the clinical implications (clinical response to antipsychotic drugs or~     emergence of metabolic side effects) of the variants in gene expression we have recently~     described in schizophrenia patients. This project takes advantage of an exceptional~     (regarding to the detailed knowledge of clinical outcome and side effect profile)~     longitudinal cohort of drug-naive patients with schizophrenia who had been followed up for~     three years at the University Hospital Marqués de Valdecilla.~   "
65085|NCT02205424|"~     Stroke and dementia are two of the most common and disabling conditions worldwide,~     responsible for an enormous and growing burden of disease. There is increasing awareness~     that the two conditions are linked, with cognitive impairment and dementia common after~     stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent~     evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet we still~     know very little about whether brain volume loss - a hallmark of dementia - occurs after~     stroke, and whether such atrophy is related to cognitive decline. The aim of this research~     is to establish whether stroke patients have reductions in brain volume in the first three~     years post-stroke compared to control subjects, and whether regional and global brain volume~     change is associated with post-stroke dementia in order to elucidate potential causal~     mechanisms (including genetic markers, amyloid deposition and vascular risk factors). We~     hypothesise that stroke patients will exhibit greater brain volume loss than comparable~     cohorts of stroke-free controls, and further, that stroke patients who develop dementia will~     exhibit greater global and regional brain volume loss than those who do not dement. An~     understanding of whether stroke is neurodegenerative, and in which patients, may be used to~     help guide the early delivery of disease-modifying therapies.~   "
65086|NCT02205411|"~     The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart~     HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death~     from refractory end-stage heart failure.~   "
65087|NCT02205398|"~     This is an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the~     orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination~     will be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on~     cetuximab or panitumumab treatment. The dose escalation part will be guided by a Bayesian~     Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC~     patients who have progressed on cetuximab or panitumumab treatment will be enrolled in two~     expansion groups to further assess the anti-tumor activity and the safety and tolerability~     of the combination of INC280 and cetuximab. Patients will receive INC280 on a continuous bid~     dosing regimen and cetuximab every week. A treatment cycle is defined as 28 days with no~     scheduled break between cycles.~   "
65088|NCT02205385|"~     Subjects are being asked to participate in this study because they have an arm or leg~     amputation and have developed pain related to a neuroma (an ongoing localized pain related~     to a cut nerve ending).~      We are studying two different types of surgery to treat the neuroma pain. Today there are~     many surgical options reported which often means that there is no one best treatment. The~     surgery that shows the best success so far, involves cutting out the scarred nerve ending~     (neuroma) and burying the freshly cut nerve ending in a nearby muscle. Recently, a new~     surgery has been developed called targeted reinnervation (TR). This surgery connects these~     cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was~     developed to allow amputees to have better prosthesis control. By chance, neuroma pain~     improved significantly with TR. We, therefore, are conducting this clinical trial to~     evaluate which of these two surgeries best treats neuroma pain. We will ask all participants~     to fill out a questionnaire both before and after surgery. This will help us understand how~     a neuroma affects the quality of life of amputees and will allow us to understand which~     surgery leads to the best improvement in neuroma pain.~      In order to confirm the presence and location of the neuroma before surgery, a magnetic~     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie~     still for a short period of time but does not involve any invasive procedures. After~     surgery, the MRI will be done again, this time to see if the nerve shows signs of scarring.~   "
65089|NCT02205372|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of~     MT-3995 in Subjects with Diabetic Nephropathy.~   "
65097|NCT02205268|"~     Background Attention Deficit Hyperactivity Disorder (ADHD) is one of the most frequently~     diagnosed behavioural disorders in childhood that requires treatment(3-5% of children). It~     is an important health problem because it impairs social, educational and occupational~     performance, and increases the risk of other psychiatric disorders including anxiety,~     depression and substance misuse. There is no cure for ADHD and standard stimulant medication~     treatment is at best symptomatic. Moreover, stimulants have side effects and parents are~     often concerned over the long-term effects. A number of non-drug treatments have been~     developed but these do not target the brain directly. Neurofeedback Training (NTx) is a new,~     non-drug treatment that targets the brain directly and that can potentially enhance the~     control of attention in ADHD. NTx could be a valuable alternative and/or adjunct to standard~     care.~      Aims Although NTx has gained popularity in Europe and the US, more rigorous studies are~     required to support its implementation in the NHS. We therefore propose a pilot study to~     establish tolerabilty and safety, and to develop treatment protocols and collect data to~     design a follow-on controlled NTx trial in ADHD.~      Methods We plan an open label, single arm, treatment trial of near infrared spectroscopy~     neurofeedback training of frontal lobe activation in school-aged children with ADHD. 48~     participants will be recruited over 1 year and will be offered 20 NTx sessions over 10~     weeks. Participants will be recruited from Mental Health Services. Primary outcomes will be~     safety and tolerability and secondary outcomes will include standard clinical behavioural~     rating scales and the Test Of the Variables of Attention.~   "
65098|NCT02205255|"~     A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.~      Our multicenter randomized trial executed in one country will provide an excellent tool for~     more precise health economic assessments. In a first approach, rough estimates on savings of~     direct costs in the entire study cohort will be made by taking into account the Flemish~     average costs for a single hospitalization day at a respiratory ward, for a day at intensive~     care, for an emergency visit, for a home physician contact and for an antibiotic-steroid~     course. A more detailed cost-effectiveness and cost-utility analysis at 3 and 9 months~     interval will only be performed in case significant clinical benefits are found in favor of~     the active treatment.~      For this purpose medical resource use data will be collected retrospectively via hospital~     invoices (direct costs including drugs, physician visits, laboratory tests, technical exams,~     medical imaging, hospital stay) but also prospectively via patient diaries, to cover direct~     and indirect costs during the entire outpatient period, and will be linked to EQ5D scores.~      Patient will have to give informed consent that additional to the clinical evaluation,~     invoices will be collected. However, individual patients can still opt out for these~     analyses (sub-study) and only participate in the medical intervention study (main study).~   "
65099|NCT02205242|"~     A first sub-analysis of the BACE trial will address physical activity levels in a subgroup~     of the intervention study with portable validated activity monitors. Physical activity is~     strongly reduced with exacerbations and failure to increase physical activity is associated~     with relapse. In addition, physical inactivity is known to be associated with cardiovascular~     and metabolic morbidity and is one of the strongest predictors of mortality in COPD. Apart~     from potential direct effects of the intervention on treatment failure and symptoms,~     positive effects on physical activity may offer considerable benefits in the long run.~      Randomized patients that are willing to participate in the sub-study will be monitored for~     activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor~     was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be~     used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive~     medical intervention, differences in recovery of physical activity will be appreciated.~      Patients will follow the standard protocol but will also wear the activity monitor for 7~     days post discharge from hospital (at investigator discretion), at day 90 (end of treatment)~     and at day 270 (end of follow-up). This device is not only registering physical activity for~     7 days but is also coupled to a standardized and patient-validated questionnaire on physical~     activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored)~     days.~      Patient will have to give informed consent for the additional measures that are related to~     the activity sub-study. However, individual patients can still opt out for these tests~     (sub-study) and only participate in the medical intervention study (main study).~   "
65100|NCT02205229|"~     Single center, prospective, observational study to assess serum concentration of ingredients~     used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.~   "
65101|NCT02205216|"~     Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and~     responds often incompletely to conventional therapy. The pathogenesis remains largely~     unknown and therapeutic alternatives are needed. Rehabilitative interventions that consist~     of learning cognitive strategies with sensory cueing to prevent and to overcome FOG~     represent the most efficacious intervention, but difficulties in learning and execution of~     these cognitive strategies are the main cause of failure. Transcranial direct current~     stimulation (tDCS) enhances motor task learning and execution in patients with PD and might~     enhance the efficacy of rehabilitative interventions.~      This study intends to address the following question whether tDCS can enhance the efficacy~     of rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?~   "
65102|NCT02205203|"~     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic~     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of~     anxiety disorders in youth, particularly those youth who may have limited access to mental~     health treatment in the traditional clinical setting.~   "
65103|NCT02205190|"~     A phase I clinical trial to compare the pharmacokinetics and safety of~     fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and~     rosuvastatin in healthy male volunteers~   "
65104|NCT02205177|"~     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic~     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of~     anxiety disorders in youth, particularly those youth who may have limited access to mental~     health treatment in the traditional clinical setting.~   "
65105|NCT02205164|"~     The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of~     palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in~     preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.~   "
65107|NCT02205138|"~     Among existing surgical techniques, spinal fusion is considered as the gold standard to~     treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and~     scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis~     and failure to relieve low back pain are unfortunately still frequent, irrespective of the~     type of procedures and grafts used by the surgeon.~      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.~   "
65108|NCT02205125|"~     Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional~     method for removal however the snared area after removal can occasionally appear uneven~     raising the possibility that complete removal has not occurred. The significance of this~     irregularity has not be studied. This study aims to separately sample the irregular area and~     determine the constituents while recording how frequently this occurs during routine~     colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue~     and do not represent polyp tissue left behind.~   "
65109|NCT02205112|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of~     intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with~     community-acquired pneumonia (CAP).~   "
65110|NCT02205099|"~     This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible~     dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable~     schizophrenia.~   "
65111|NCT02205086|"~     This study compares the ability of clinicians to make diagnoses with or without the~     assistance of diagnostic decision support software. The area of clinical focus is primarily~     rheumatology.~   "
65112|NCT02205073|"~     This is a single site, randomized, double-blind, three period cross-over,~     placebo-controlled, proof of mechanism study in healthy male subjects. The study will~     investigate whether the directionality of brain activity and connectivity in response to~     intranasal vasopressin treatment is similar to earlier studies and explores the effect of~     short-term treatment with RG7314 on functional MRI as a pharmacodynamic marker. While in the~     scanner, the participants will be asked to perform a face matching task and a Theory of Mind~     task, among other assessments. Participants' exposure to study drug will be assessed and all~     participants will receive follow-up examination 1 and 4 weeks after last dose.~   "
65113|NCT02205060|"~     The therapeutic efficacy of virtual reality has been validated for the treatment of various~     mental disorders ,smoking behavior is the first preventable cause of death in developed~     countries However, after a successful withdrawal, a high relapse rate (between 40 and~     70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual~     reality cue exposure for the relapse of tobacco consumption~   "
65114|NCT02205047|"~     The purpose of this study is to find out whether either trastuzumab or the combination of~     trastuzumab and pertuzumab with standard chemotherapy shows more activity against~     gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery~     and it can be safely administered.~   "
65115|NCT02205034|"~     The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling~     leading to failure to thrive in the most severe cases, subsequently followed by an early~     onset of morbid obesity with hyperphagia and deficit of satiety, combined with other~     endocrine dysfunction probably due to hypothalamic dysfunction. The pathophysiological~     mechanism of the occurrence of the 2 main nutritional phases of PWS is unknown. Swaab~     reported a deficit in the oxytocin (OT)-producing neurons of the paraventricular nucleus in~     the brain of these patients. In addition of its well-known anorexigenic effect, OT is~     involved in establishing and maintaining social codes. Moreover in a PWS mouse model~     generated from a MAGEL2 KO gene a single OT injection at 5 hr of life prevent the early~     death observed in 50 % of the new born mice by recovering normal suckling. Interestingly~     this effect is no longer observed if OT injection takes place later. Our hypothesis is that~     early administration of OT in babies with PWS may improve suckling and possibly~     infant-mother interactions. In our recent study (manuscript in preparation), we have shown~     that a single intranasal administration of OT is well tolerated. This escalating dose study~     is designed to evaluate the tolerance of repeated intranasal administration of OT in 3 steps~     (4IU every other day, 4 IU daily, 4IU twice daily) in babies younger than 5 months with PWS.~   "
65116|NCT02205021|"~     Accumulation of fat in the neck using tape measures has been linked to increased~     cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat~     using computed tomography will show that specific fat compartments in the neck contribute~     differently to cardiovascular risk.~   "
65117|NCT02205008|"~     Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate~     intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although~     we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal~     chemotherapy have been published.~      In this study, we review the clinicopathological characteristics of patients and effects of~     early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric~     cancer-specific survival and patterns of recurrence of gastric cancer patients with~     macroscopic serosal invasion.~      The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall~     and disease free survival of advanced gastric cancer patients with serosal invasion after~     potentially curative surgery.~   "
65118|NCT02204995|"~     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in~     postmenopausal women. Many surgical treatments have been described and recent literature has~     show that the relatively simple trapeziectomy gives equal results and less complications,~     when compared to other techniques such as ligament reconstructions and interpositions. These~     studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis.~     Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which~     increases the chance for collapse of the first metacarpal bone and associated problems.~      The investigators' hypothesis is that an LRTI can be of additional value in patients with~     stage 4 osteoarthritis.~   "
65119|NCT02204982|"~     A study to evaluate the safety and efficacy of IPI 145 administered in combination with~     rituximab vs placebo in combination with rituximab in patients with previously treated~     CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.~   "
65120|NCT02204969|"~     The thermal therapy combined with magnetic fields and ozone has a direct effect on patients~     with dementia and Alzheimer's with a regression of more than 60% of them~   "
65121|NCT02204956|"~     Smoking rates among individuals with psychiatric disorders are disproportionately higher~     than the general population. The majority of psychiatric hospitals ban smoking on hospital~     grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers~     in inpatient psychiatric settings are infrequently provided with referrals for cessation~     treatment on discharge (< 1 %) and most resume smoking upon discharge. Therefore, the~     integration of effective cessation interventions within the current mental health treatment~     system is a public health priority.~      The overall objective of this project is to adapt an Extended Care (ExC) model to smokers~     with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a~     randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted ExC~     in real-world practice. We will test the hypothesis that, among smokers with SMI in~     inpatient psychiatric treatment (n = 422), ExC will result in significantly greater rates of~     cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a~     group that receives Brief Education (BE) about smoking cessation. Furthermore, we~     hypothesize that a higher proportion of ExC vs. BE patients will use evidence-based smoking~     cessation treatment (counseling and pharmacotherapy) in the month after discharge. We will~     also explore the effect of ExC on health and health care utilization in the 12 months~     post-discharge (psychiatric symptoms, psychiatric and medical hospital readmissions and~     emergency room visits) and the effectiveness of ExC on smoking abstinence in patient~     diagnostic subgroups.~      The expected outcome of this project is a demonstration of the effectiveness of an Extended~     Care intervention for smoking cessation in individuals with severe mental illness (SMI)~     following psychiatric hospitalization. Future studies could extend these findings to~     individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall,~     this research would have a significant positive public health impact that will move us~     closer to the long-term goal of dissemination and integration of the Extended Care model to~     increase smoking cessation and decrease smoking related morbidity and mortality in people~     with severe mental illness.~   "
65122|NCT02204943|"~     This study will examine biomarkers involved in osteomimicry in bone metastases and~     circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the~     bone-targeting radiopharmaceutical radium-223. This study will also examine the~     bio-distribution of radium-223 in bone and bone metastases of men with mCRPC.~      The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly~     express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding~     osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will~     target both of these compartments including the more mesenchymal/osteoblastic tumor cells~     and the surrounding osteoblasts in the active bone microenvironment, with a relative sparing~     of normal bone and bone marrow.~   "
65123|NCT02204930|"~     The purpose of this First in Man study is to evaluate the safety and tolerability, as well~     as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in~     patients undergoing open liver resection surgery.~   "
65124|NCT02204917|"~     In this clinical trial the investigators aim to evaluate the diagnostic feasibility and~     safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and~     urethral imaging in children.~   "
65125|NCT02204904|"~     Study ALD 103 is a multi-site, global, data collection study that is designed to evaluate~     safety and efficacy of allogenic hematopoietic stem cell transplantation (allo-HSCT) in~     patients with CALD aged 17 or younger.~   "
65126|NCT02204891|"~     The aim of the present study is to demonstrate the effect of a mixture of four species of~     probiotics (Saccharomyces boulardii, Bifidobacterium lactis BB-12, Lactobacillus acidophilus~     LA-5 and Lactobacillus plantarum) in patients with symptomatic irritable bowel syndrome~     (IBS) who have culture verified syndrome of intestinal bacterial overgrowth (SIBO) and those~     who do not have. This will provide direct evidence for the role of probiotics in treating~     part of the pathogenesis of IBS.~   "
65127|NCT02204878|"~     To searching the role of parecoxib sodium for postoperative pain management in open~     hepatectomy~   "
65128|NCT02204865|"~     Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing~     for periods whilst asleep, is common in heart failure and associated with a poor prognosis.~     This study aims to validate a novel function available on certain pacemakers which is~     designed to detect this condition.The investigators hypothesize that ApneaScan can~     accurately detect moderate to severe sleep disordered breathing in patients with heart~     failure as compared against an Embletta sleep study. The investigators will also follow up~     our patients for 2 years to determine whether the severity of sleep disordered breathing as~     assessed by ApneaScan correlates with prognosis.~   "
65129|NCT02204852|"~     Objective Evaluating the safety and efficacy of iloprost and eptifibatide co-administration~     compared to placebo as an addition to standard care in septic shock patients.~      Trial rationale Iloprost and eptifibatide combination therapy in septic shock patients is~     expected to deactivate the endothelium and restore vascular integrity, reduce formation of~     microvascular thrombosis and dissolve existing clots in the microcirculation and maintain~     platelet counts, thereby improving platelet-mediated immune function and reducing the risk~     of bleeding. Together this is expected to translate into reduced organ failure and improved~     outcome in patients with septic shock.~      Trial population The trial population is patients >18 years admitted to the ICU with septic~     shock within the last 24h. Eighteen evaluable septic shock patients will be included.~      Trial design This is a single center, randomized (2:1, active:placebo), placebo controlled,~     double-blind investigator-initiated phase IIa trial in patients with septic shock,~     investigating the safety and efficacy of co-administration of Iloprost and Eptifibatide as a~     48h continuous i.v infusion in totally 18 patients.~      All patients will receive standard ICU care including LMWH thrombosis prophylaxis.~      As all patients present at the trial site in an acute, critical condition, scientific~     guardians will co-sign the informed consent form before inclusion. Next-of-kin and the~     patients' general practitioner will co-sign as soon as possible and the patient will provide~     informed consent whenever possible. The active treatment is expected to improve the clinical~     condition of the individual patient and to provide information that may translate into~     improved therapy of future sepsis patients.~      During the study, blood samples will be taken at different time points. Patients will be~     observed and assessed continuously with regards to complications including bleeding.~     Patients will be actively assessed as long as the patient is in the ICU. During the extended~     follow up period at day 30 and 90, contact will be made with the patients to follow up on~     safety events and vital status.~      The trial is conducted in accordance with the protocol and the current regulatory~     requirements and legislation in Denmark.~      Investigational product The active treatment in the trial comprises co-administration of 1~     ng/kg/min Ilomedin® and 0.5 µg/kg/min Integrilin® as 48h continuous i.v infusions. The drugs~     will be purchased and administered according to the product specifications.~      Placebo The placebo in the trial is 0.9% saline as 48h continuous i.v infusion, which will~     be used as placebo for both study drugs. The i.v volume of placebo saline to be administered~     is equal to the administered volume of diluted (in 0.9% saline) active drug.~      Data protection In compliance with the Danish data protection law, the trial will be~     approved by the Danish Data Protection Agency.~      Sponsor of study and financial support This research project is investigator-initiated by~     the trial sponsor and co-investigator Sisse R. Ostrowski and co-investigator Pär I.~     Johansson in collaboration with the principal investigator Morten Bestle.~      It has not received funding from any commercial sponsors.~      Time line Patient recruitment period runs from September 2014 to August 2015. Follow-up data~     on 30-day and 90-day outcome and adverse events will be collected. Initial data analyses~     will be done after completion of 30-day follow-up for all patients. Secondary data analyses~     will be done after completion of 90-day follow-up for all patients.~   "
65130|NCT02204839|"~     The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,~     Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate~     feeding and rapid-acting insulin dose recommendations will protect patients with type 1~     diabetes from early- and late-onset hypoglycaemia following evening time exercise.~   "
65131|NCT02204826|"~     Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting~     herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate~     its therapeutic characteristics. KRG has been shown to be effective in many diseases, such~     as cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency~     syndrome, and sexual dysfunction. Several studies have indicated effects of ginseng on~     improving spermatogenesis in animals. The major mechanisms behind these effects were~     speculated to be anti-oxidant and anti-aging effects, as well as modulation of the~     hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human~     clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male~     infertility.~      Only a small proportion of causes of male infertility are currently curable, including male~     hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia~     that can be corrected by surgery. In addition, evidence-based medicine has revealed that~     most empirical treatments are ineffective. Similarly, the efficacies of carnitine,~     anti-estrogens, kallikrein, vitamins C and E, and glutathione have not been confirmed.~      Therefore, the investigators investigated the effects of KRG on semen parameters in male~     infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic~     effects of KRG in male patients.~   "
65132|NCT02204813|"~     There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y~     gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part~     to an intestinal hormone, called GLP-1, that is released into the circulation immediately~     after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial~     effects of RYGB surgery on glucose homeostasis in humans.~   "
65133|NCT02204800|"~     Active surveillance in kidney cancer involves closely observing the tumor with periodic~     imaging studies rather than immediately proceeding to an invasive treatment. This does not~     mean that the tumor is ignored or that future treatment is not necessary, rather it means~     the tumor does not require treatment at this time. On active surveillance, a tumor is~     closely monitored without treatment, however if the tumor changes and reaches a predefined~     threshold that your physician no longer considers safe, your physician will strongly~     encourage treatment.~   "
65134|NCT02204787|"~     The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation~     technique, tDCS (transcranial direct current stimulation) used as a complementary treatment~     on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham~     tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes~     shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms~     and social functioning.~   "
65135|NCT02204774|"~     The objective of this prospective cohort study in patients with a known thoracic aortic~     aneurysm is to test the hypothesis that yearly aneurysm progression rate is higher in~     patients with obstructive sleep apnoea (OSA) compared to patients without OSA, and that the~     need for aortic operation or proven or presumed death from aortic rupture or dissection~     happens more often in patients with thoracic aortic aneurysm and OSA compared to patients~     without OSA.~   "
65136|NCT02204761|"~     This pilot clinical trial studies proton beam radiation therapy in treating patients with~     thoracic cancer that has come back and have received prior radiation therapy. Proton beam~     radiation therapy uses high energy protons to kill tumor cells and may cause less damage to~     normal tissue.~   "
65137|NCT02204748|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Specifically, posterior~     stabilizing (PS) knees have been found to be associated with lower amounts of posterior~     femoral rollback, higher occurrence of reverse axial rotation and increased amount of~     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB)~     knee system has incorporated subtle changes in its design to address restoration of~     kinematics that more closely resemble those of a normal knee. To understand if this design~     is able to effectively restore kinematics in the implanted knee, further in vivo analysis is~     necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months~     post-operatively using the University of Tennessee's mobile fluoroscopy unit while~     performing three daily activities, level walking, ramp down and deep knee bend. Since this~     is a pilot study, there is no hypothesis.~   "
65138|NCT02204735|"~     While eating the majority of energy earlier in the day appears to have a positive effect on~     weight and cardiometabolic outcomes, it is not clear how eating earlier in the day~     influences other behaviors that have a circadian rhythm (sleep), other energy balance~     behaviors important for weight loss (physical activity), and self-reported feelings of~     appetite control (hunger and fullness). Thus the purpose of this study is to examine the~     influence of timing of eating on sleep patterns, physical activity, and self-reported~     feelings of appetite control. It is hypothesized that those who eat the majority of their~     calories earlier in the day will have greater weight loss than those who eat the majority~     later in the day.~   "
65139|NCT02204722|"~     This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all~     patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic~     phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level~     after three month dosing and be maintained their dose of 400mg/day. On the other hand, the~     group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day.~     The superiority of the group B will be proved by evaluating the MMR rate of these two groups~     after 12 months of administeration of Imatinib.~   "
65140|NCT02204709|"~     The purpose of this study is to determine how eating fish raised to have different levels of~     omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated~     cardiovascular risk.~   "
65141|NCT02204696|"~     The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive~     sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with~     normal soft palate and uvula length.~   "
65142|NCT02204683|"~     The main goal is to study way that aflibercept injection behaves in the eye and in the body~     of patients with wet macular degeneration, in patients who have had previous vitreous~     removal surgery.~   "
65143|NCT02204670|"~     Background :~      Regular exercise is a cornerstone in the prevention and the management of comorbidities.~     Unfortunately, the metabolic benefit of exercise training is not universal and varies among~     individuals. A main factor likely to explain the exercise training variability is the lack~     of empirical evidence on the determinants of exercise training. A series of muscle-derived~     cytokines have recently been discovered that (1) are released during exercise and (2) exert~     positive effects on peripheral tissues. Irisin is one of these novel myokines and might~     contributes to the metabolic adaptations to exercise training.~      Methods:~      The investigators will perform a pilot cohort study in which obese adolescents will perform~     resistance exercise training for 6 weeks. The main exposure variable will be the acute~     release of irisin during resistance exercise. The main outcome measures will be the change~     in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral~     glucose tolerance test.~      Study Hypothesis:~      The primary overall hypothesis is that the change in plasma Irisin with a single bout of~     exercise will be associated with the metabolic adaptations to 6 weeks of resistance~     training, specifically, the reductions in hepatic triglyceride content and post-prandial~     glucose excursions, in obese adolescents.~   "
65144|NCT02204657|"~     The purpose of this study is to determine if professional Continuous glucose monitoring~     improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes~     Mellitus~   "
65145|NCT02204644|"~     A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line~     treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.~      Randomized,Open Label,Control~   "
65146|NCT02204631|"~     The goal of this study is to assess the experience of our patients with head and neck cancer~     in regard to the information they receive, their symptoms, and their understanding of their~     diagnosis, to determine ways to improve upon these aspects of patient care in the future.~   "
65170|NCT02204319|"~     The objectives of this pilot study are to demonstrate effectiveness of application of the~     Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk~     low level laser red diode light therapy device, in providing relief of pain symptoms in~     patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use~     of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar~     vestibulitis has on the patient's daily activities, relationships and emotional well-being.~   "
65147|NCT02204618|"~     The investigators assume that cochlear implants in this indication are not only effective~     but also cost-effective. The investigators' experimental protocol relies on real life~     therapeutic strategy, where a cochlear implant may be proposed once CROS and bone~     conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and~     bone conduction devices. If these trials are ineffective, the remaining subjects will be~     randomized between two arms (cochlear implantation vs 6 months abstention followed by~     cochlear implantation). A comparative cost-utility analysis between the two arms, of medical~     consequences measured in terms of quality of life will identify a preference for a strategy.~     Specific binaural hearing measurements with respect to each treatment option (abstention,~     CROS, bone conduction device, cochlear implant) will also be collected.~   "
65148|NCT02204605|"~     The investigators would like to determine if there is a difference in patient satisfaction~     among patients who have puzzling pain conditions and receive one evaluation from their~     treating physician, and those that receive an evaluation from their treating physician and~     from a group of consulting physicians by video. The investigators expect to enroll 128~     patients at Massachusetts General Hospital.~   "
65149|NCT02204592|"~     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article~     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by~     work-related stress. A broadly applicable description defines burnout as a state of mental~     and physical exhaustion related to work or care giving activities. A long-standing~     conceptual and operational definition characterized burnout as a triad of emotional~     exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous,~     and detached responses to others), and reduced personal accomplishment (feelings of~     competence and achievement in one's work) In the World Health Organization International~     Classification of Diseases, 10th revision, burnout is defined as a state of vital~     exhaustion. Although no specific diagnosis of burnout is mentioned in the Diagnostic and~     Statistical Manual of Mental Disorders, burnout is a clear syndrome with significant~     consequences.~      Burnout in health care professionals has gained significant attention over the last several~     years. Given the intense emotional demands of the work environment, clinicians are~     particularly susceptible to developing burnout above and beyond usual workplace stress.~     Residency training, in particular, can cause a significant degree of burnout, leading to~     interference with individuals' ability to establish rapport, sort through diagnostic~     dilemmas, and work though complex treatment decision making. Overall, burnout is associated~     with a variety of negative consequences including depression, risk of medical errors, and~     negative effects on patient safety. The goal of this review is to provide medical educators~     and leaders with an overview of the existing factors that contribute to burnout, the impact~     of burnout, inter specialty variation, and suggestions for interventions to decrease~     burnout.~   "
65150|NCT02204579|"~     This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor~     antagonist) on activating mutations of the Calcium-sensing receptor in patients with~     Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an~     inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and~     hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV~     infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary~     depending on measured levels of ionized calcium.~   "
65151|NCT02204566|"~     12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone~     Radio frequency (RF) ablation will be asked to swallow the capsule.~      As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation~     caused any form of damage to the esophagus considering it being so close to the heart.~      After the capsule has been removed from the mouth, they will be asked about the tolerability~     of the capsule.~   "
65152|NCT02204553|"~     This will be a multi-center, open label, expanded treatment protocol of panobinostat,~     bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.~     Panobinostat will be administered at a starting dose of 20mg orally three times a week~     (every other day) for two weeks on and one week off, with dose adjustments permitted based~     on observed toxicity. Bortezomib will be administered either intravenously or~     sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of~     treatment, patients who have achieved stable disease or better by modified EBMT 1998~     criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of~     a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks)~     patients with stable disease or better may continue on therapy at the discretion of their~     investigator until September 2015 or until drug is commercially available, whichever comes~     first. Patients who have not achieved at least stable disease by 8 cycles must discontinue~     from study treatment. Dexamethasone will be administered on the day of and the day~     immediately following bortezomib treatment. Patients will not receive any study treatment~     during the third week of each cycle. Cycles will be defined as 21 days of treatment.~     Investigators may not add any other anti-myeloma agents (with the exception of~     bisphosphonates) while patients remain on study treatment. Patients will remain on study~     until disease progression, unacceptable toxicity, or end of the study~   "
65153|NCT02204540|"~     This study tests the feasibility of having study participants use webcams to participate in~     research studies. The study scientists hypothesize (1) that webcams will be an adequate~     method of detecting a participant's ability to perform a tasks for a clinical trial (e.g.,~     swallowing a pill, eating food) and (2) that a majority of study participants would be~     willing to use a webcam to participate in a research study.~   "
65154|NCT02204527|"~     In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown~     to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D~     supplementation in patients with type 2 diabetes and hypertension~   "
65155|NCT02204514|"~     The purpose of this study is to assess the pain-relieving effects of surgery for painful~     external snapping hip.~   "
65156|NCT02204501|"~     The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of~     528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of~     midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK~     profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well~     as the safety of vapendavir will also be assessed.~   "
65184|NCT02204137|"~     The purpose of this research study is to look at the use of a series of questionnaires~     evaluating risk for falls in order to collect information that might be used to develop a~     larger study aiming to recognize who is more at risk for falls and how to best intervene to~     prevent falls in older adults with cancer.~   "
66053|NCT02192749|"~     Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells~     administered intravenously (IV) in a series of 4 infusions every 3 months over the course of~     one year is safe and will induce a therapeutic effect in autism patients.~   "
65157|NCT02204488|"~     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in~     postmenopausal women. Many surgical treatments have been described and recent literature has~     show that the relatively simple trapeziectomy gives equal results and less complications,~     when compared to other techniques such as ligament reconstructions and interpositions. A~     relatively new treatment modality, which has been further developed in recent years is the~     total joint arthroplasty. Randomized prospective trials and long-term results are lacking,~     but prospective cohorts show a faster recovery and good results after one year, without an~     increase in complication rate.~      We hypothesize that a total joint arthroplasty gives a better objective and subjective~     result after one year than a trapeziectomy.~   "
65158|NCT02204475|"~     This is a randomized, multi-site, open-label trial of a fixed-dose combination of~     Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon~     (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1~     hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion~     of treatment-naive (TN) and prior treatment failure (PTF) participants treated with~     grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic~     acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the~     proportion of BOC/PR-treated participants achieving SVR12.~   "
65159|NCT02204462|"~     Our preclinical studies suggest the capacity of the positron emission tomography imaging~     agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast~     tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy~     than that obtained by existing breast imaging tools.~   "
65160|NCT02204449|"~     The current study is a randomized controlled trial, being conducted at two hospitals in~     Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an~     intervention group, in which they will receive mentorship from a volunteer cardiac~     rehabilitation peer mentor, and a control group, in which they will receive usual care.~     Patients in both groups will be tracked to determine if they are referred to cardiac~     rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to~     cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac~     rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac~     rehabilitation.~   "
65161|NCT02204436|"~     Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a~     cosmetic treatment for spotted hand skin; in particular it was investigated the synergic~     activity of an emulsion, with clarifying-antioxidant activity combined with an activator~     gel, with hydration and keratolytic activity.~      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were~     included in the study.~      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by~     the volunteers and tolerance both by investigator and volunteers.~   "
65162|NCT02204423|"~     Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold~     standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI),~     where most benefits of the radial approach, such as reduced major bleeding and mortality,~     can be expected. However there is very limited research available looking at the~     consequences of trans-radial access for upper extremity function.~      The main objective of this study is to provide insight in the morbidity with regards to the~     upper extremity surrounding the radial access route in percutaneous coronary interventions.~     Secondary objectives are to provide insight in the consequences for functional status,~     factors influencing and financial costs of this morbidity, to identify subject who might~     benefit from early referral and treatment of this morbidity and to generate hypotheses for~     further clinical research into this matter.~      The investigators hypothesis is that approximately 20% of the population will experience~     upper extremity dysfunction after TR-PCI.~   "
65163|NCT02204410|"~     This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids~     for deficient emotional self-regulation (DESR) as a supplement to ADHD treatment in children~     and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the~     ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity~     Disorder but still experience DESR traits.~   "
65164|NCT02204397|"~     A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of~     INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in~     patients with established T1DM.~   "
65165|NCT02204384|"~     To compare the acute effect of soluble fiber intake from foods or supplement after a common~     meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The~     hypothesis is a meal with a high content of soluble fiber from food determines glycemic and~     insulinemic response similar to a meal with a high content of soluble fiber from supplement~     sources.~   "
65166|NCT02204371|"~     This study will investigate whether pazopanib can reduce epistaxis and improve anaemia in~     subjects with hereditary haemorrhagic telangiectasia (HHT) at a dose that is well tolerated.~     The study will have 2 parts. Part A will be an open label, dose-escalation study in which up~     to 4 cohorts of approximately 6 subjects each will receive increasing doses of pazopanib for~     a maximum of 12 weeks. The dose in the first cohort will be 50mg per day and the maximum~     dose in a cohort will be 400 mg per day. Dose escalation will not occur as planned if the~     predefined safety stopping criteria are met or at least 4 subjects in a cohort have~     demonstrated efficacy (as measured by epistaxis, haemoglobin, transfusion or iron infusion~     requirements). If efficacy is demonstrated in Part A with an acceptable safety profile, Part~     B will be initiated to further define the optimal dose(s) including dose duration/schedule~     and to provide further support for the proof of mechanism. Approximately 15 subjects will~     participate and will be randomised to active or placebo in a ratio of 3:2. This part of the~     study will be double-blind.~   "
65167|NCT02204358|"~     Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial~     dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide~     clinical evidence for the treatment of uterine infertility~   "
65168|NCT02204345|"~     A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and~     paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.~   "
65169|NCT02204332|"~     The purpose of this study is to determine efficacy and safety of cabazitaxel administration~     in patients with colorectal cancer resistant to standard treatment.~   "
65171|NCT02204306|"~     In gastric cancer patients treated with 5-FU and cisplatin, higher tumor TS levels were~     associated with a less favorable response (29% vs. 68%; p=0.024). Similarly, in a study in~     which patients were treated with high dose 5-FU, patients with high TS expression had a~     response rate of only 12.5%. Conversely a response rate of 92.9% was observed in patients~     with low tumor TS expression. A longer but not statistically significant survival advantage~     was observed in patients with the TSER*2 allele compared with the TSER*3/*3 patients.~     Additionally, a review by Patel et al. identified approximately 20 gastric cancer studies~     that have found a positive association between TSER genotype and clinical response (in~     either direction). Therefore, the primary goal of this proposal is to prospectively genotype~     patients, select patients with good risk TSER genotypes (TSER*2*/*2 or *2/*3) and treat~     them with a standard 5-FU containing regimen (FOLFOX) in order to improve clinical outcomes,~     while randomize patients with the poor risk TSER genotype (*3/*3) to either the standard~     5-FU containing regimen or another non-5-FU-based regimen (docetaxel/cisplatin).~   "
65172|NCT02204293|"~     Interleukin-1 antagonists such as canakinumab have been used for the treatment of AOSD and~     have had a marked influence on the activity of the disease, including joint mobility.~     Results from controlled clinical studies are not, however, currently available.~   "
65173|NCT02204280|"~     Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In~     most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in~     the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker~     in type 1 diabetes, because approximately 50% of type 1 diabetes patients with~     microalbuminuria will eventually develop diabetic nephropathy. Conversely, microalbu-~     minuria is of much less value as a marker in DM because it has a variety of causes,~     including hypertension. Thus, additional markers are needed to identify patient groups with~     a high risk of developing overt diabetic nephropathy. The aims of this study is checking~     urine UbA52 levels with ELISA to identify its significance in the diagnosis of diabetic~     nephropathy.~   "
65174|NCT02204267|"~     Investigator-initiated prospective randomized multicentre study to uncover the true burden~     of paroxysmal atrial fibrillation in a representative population of acute stroke patients~     without known atrial fibrillation.~   "
65175|NCT02204254|"~     Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like~     flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments~     include topical (metronidazole) and systemic (doxycycline) antibiotics with only a~     suspensive effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a~     device emitting an electromagnetic current inducing an increase in temperature when applied~     on the skin, potentiated by infrared light. The monopolar RF has already been used in~     rosacea on a small number of cases with positive and prolonged results. RF with Elos system~     has been evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex~     folliculorum (DF) is a long transparent mite which asymptomatically parasitizes~     pilosebaceous follicle of normal human skin sometimes responsible of inflammatory facial~     dermatoses. The prevalence and density of DF are increased in rosacea, and DF is suspected~     to play a role in the pathogenesis of rosacea. DF is sensitive to heat, and the~     investigators hypothesize that radiofrequency treatment may affect the survival of the mite~     and should be effective to treat papulopustular rosacea.~   "
65176|NCT02204241|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)~     patients.~   "
65177|NCT02204228|"~     The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder~     construct. When used under the conditions and purposes intended the TRS will relieve pain~     and restore some functional joint motion to the affected shoulder. The purpose of this study~     is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.~   "
65178|NCT02204215|"~     Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery.~     The purpose of this study is to determine whether electric acupuncture therapy is effective~     in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with~     sepsis or multiorgan system failure.~   "
65179|NCT02204202|"~     The purpose of this research study is to gain understanding of the basic responses of the~     lungs to inflammation and specifically if there may be a better way to detect graft~     inflammation using non-invasive methods as well as to determine the effectiveness of~     immunosuppressive treatment regimens in preventing acute rejection in lung transplant~     recipients.~   "
65180|NCT02204189|"~     The purpose of this study is to determine whether TongFuSan is effective in the treatment of~     acute pancreatitis with gastrointestinal dysfunction.~   "
65181|NCT02204176|"~     The rate of adult obesity in the United States has increased more than two times since 1970,~     and the rate of child-teen obesity has increased by four times. One of the antecedents of~     obesity is an inactive lifestyle. Exercise has been known to be associated with increases in~     both physical and mental health by increasing longevity, preventing risk of obesity,~     coronary heart disease, and hypertension, and increasing self-esteem and overall quality of~     life. The broad aim of the current study is to investigate the effectiveness of~     psychoeducational training to increase exercise activity initiation and maintenance in young~     adults.~      The goal of this study is to compare three training approaches for college students to~     increase exercise behavior. One approach provides general information on the different types~     of exercises and benefits of engaging in exercise behavior after an initial questionnaire~     assessment session. A second approach includes the general exercise information and~     questionnaire assessment as well as training on how to create specific goal intentions~     (i.e., implementation intentions) to aid in exercise initiation. A third approach uses all~     the components of the second approach but also tests the utility of a personality-informed~     module by incorporating concepts from the theory of learned industriousness. It is expected~     that the third approach will be the most effective in helping participants initiate and~     maintain their exercise activities during the course of the study duration.~   "
65182|NCT02204163|"~     Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin®~     in infants/toddlers with Prader-Willi syndrome~   "
65183|NCT02204150|"~     The main purpose of this research is to test the feasibility and tolerability of the~     tethered capsule Optical Frequency Domain Imaging (OFDI) screening probe in healthy~     subjects, patients with Barrett's Esophagus and Eosinophilic Esophagitis.~   "
65185|NCT02204124|"~     The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation,~     and stenosis (narrowing) near the head of the pancreas. This is a prospective observational~     study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and~     postoperative morbidity (the presence of illness or disease). The findings will then be~     compared to patients whose Whipple procedure will be performed using conventional dissection~     and hemostasis techniques.~   "
65186|NCT02204111|"~     The primary objective of the study is to compare quality of life (QoL) between patients~     suffering from soft tissue sarcoma, receiving a multidimensional intervention with those~     receiving standard treatment.~   "
65187|NCT02204098|"~     The purpose of this research study is to find out about the safety of injecting the gene~     (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was~     purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein~     that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way~     to generate an immune response to breast cancer cells. There is evidence that an immune~     response may be a way to fight cancer. In addition to evaluating the safety of the~     mammaglobin-A injection, this study is also looking at the immune response that the~     participant's body has after each injection.~   "
65188|NCT02204085|"~     This research study is studying a targeted therapy known as GO-203-2C as a possible~     treatment for with acute myeloid leukemia (AML) both alone and in combination with~     decitabine. GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a~     Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational~     intervention and also tries to define the appropriate dose of the investigational~     intervention to use for further studies.~   "
65189|NCT02204072|"~     The overall aim of the trial is to investigate the safety and anti-tumour activity of an~     experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,~     compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients~     that have previously been treated and failed on docetaxel and abiraterone treatments.~     Initially, a tolerability and safety phase (phase Ib escalation) will be performed to~     confirm the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and~     enzalutamide that can be taken together.~      Once the MTD, or recommended phase II dose, have been determined an expansion cohort will~     also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have~     a rise in prostate serum antigen (PSA) levels. Patients may not have received prior~     docetaxel or abiraterone. Patients in this cohort will receive the MTD, or recommended phase~     II dose, of BI 836845 and enzalutamide determined in the phase Ib escalation phase.~      The randomised trial (phase II) will be an open label, parallel group study design in a 1:1~     ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the~     MTD/recommended doses, or enzalutamide alone (Arm B).~      In all parts of the trial safety, anti-tumour activity will be assessed, in addition to~     circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and~     determination of Overall Survival (OS).~   "
65190|NCT02204059|"~     The primary objectives of this study is to assess the safety and tolerability of~     intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to~     investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in~     patients with non-small cell lung cancer (NSCLC)~   "
65191|NCT02204046|"~     The primary objectives of this study were to assess the safety and tolerability of~     intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate~     the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with~     adenocarcinoma of the breast~   "
65192|NCT02204033|"~     The general aim of the present study was to assess the safety and tolerability of~     intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re)~     -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc -~     labelled hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled~     hMAb BIWA 4 and to propose a safety dose for phase II development.~   "
65193|NCT02204020|"~     Despite improvements in outcomes after Hematopoietic Cell Transplantation (HCT) for Acute~     Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), the risk of relapse remains high~     and is the most common cause of mortality after HCT. Moreover, treatment options for relapse~     after HCT are limited. Strategies to reduce relapse with maintenance therapy in patients who~     are at high risk are needed to improve survival. 5-aza is a hypomethylating agent that has~     shown immune modulating properties that may enhance the graft-versus-leukemia (GVL) effect,~     including upregulation of tumor-associated antigen and costimulatory molecule expression.~     Moreover, 5-aza has properties that suggest protection against graft-versus-host disease~     (GVHD) as well. Preliminary data shows that it is well tolerated and effective in clinical~     use for the treatment of AML or MDS relapse after HCT, as well as for maintenance therapy.~     This study will evaluate the use of 5-aza for maintenance after HCT in patients with AML or~     MDS with risk factors that are associated with a high risk for relapse.~   "
65194|NCT02204007|"~     This is an observer-blinded prospective randomized clinical trial to define the efficacy of~     a new technology developed at the Cleveland Clinic to improve the positioning of the~     acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have~     consented to total hip arthroplasty with or without screw fixation for treatment of hip~     pathology. This treatment is standard of care. Patients will receive standard of care pre-~     and post-operative care and placement of standard of care implants all of which are~     commercially available and FDA approved for general use for the clinical indications used in~     these patients. The only difference in treatment between the groups will be the use of a~     surrogate bone model to help assist the surgeon visualize the ideal placement of the~     acetabular component. Diagnostic testing performed specifically related to this study~     consists of obtaining one pre-operative and one post-operative CT scan. The post-operative~     scan is to be performed within two weeks of surgery.~      The investigators predict that those patients with 3D imaging and bone model will have~     better acetabular shell placement than those with standard preoperative planning.~   "
65208|NCT02203825|"~     This Phase I clinical trial is evaluating chimeric-antigen receptor (CAR) T-cells (CM-CS1 T~     cells) which recognize NKG2D-ligands on the surface of cancer cells. This study evaluates~     the safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells~     to patients with AML, MDS-RAEB and Multiple Myeloma.~   "
65195|NCT02203994|"~     Spasticity is the most problematic self-reported secondary medical problem in patients with~     spinal cord injury. It has the potential to negatively influence quality of life through~     restricting activities of daily living. Problematic spasticity can cause pain and fatigue,~     disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a~     negative effect on patients morbidity. For this reason there is enormous interest in~     therapeutic interventions addressing to decrease spasticity in persons with spinal cord~     injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on~     spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no~     studies are published, assessing the effect of extracorporeal shock wave therapy on focal~     spasticity in patients with spinal cord injury.~      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb~     spasticity in patients with an incomplete spinal cord injury.~   "
65196|NCT02203981|"~     To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.~   "
65197|NCT02203968|"~     Trauma is the leading cause of death in people 44 years of age or younger. After major~     trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting~     defects is responsible for most of deaths in the first hours of hospital admission. Of note,~     these bleeding-related deaths are potentially preventable. Accordingly, the initial~     in-hospital management of severely injured patients focuses on stopping bleeding, replacing~     blood loss and correcting clotting defects.~      Recently, animal and human research demonstrated that one of the major clotting defects~     following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor),~     which is detected on hospital admission in severely injured patients. These low fibrinogen~     levels are associated with increased blood transfusion and death. However, in North America,~     the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which~     is a frozen blood product with long preparation time, and similarly to other blood products,~     carries the risk of viral transmission and transfusion complications. Alternately, many~     Europeans countries where cryoprecipitate has been withdrawn from the market due to safety~     concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen~     inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and~     parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada,~     fibrinogen concentrate is licensed for congenital low fibrinogen only.~      Although preliminary data suggest that fibrinogen supplementation in trauma is associated~     with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of~     early fibrinogen replacement remains unknown. We proposed to conduct a feasibility~     randomized trial to evaluate the use of early fibrinogen concentrate against placebo in~     injured patients at our trauma centre.~      A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering,~     and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in~     trauma. This feasibility trial will provide preliminary safety and clinical outcome data to~     inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths~     in the trauma population.~   "
65198|NCT02203955|"~     The main objective is to compare prebiotic therapy with placebo for the prevention of~     pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal~     anastomosis. This study will also characterize the effects of prebiotics on the fecal~     microbiota and fecal microbial metabolites and correlate these effects with the primary~     outcome of development of pouchitis.~   "
65199|NCT02203942|"~     Vaginitis is the most common condition encountered in the gynecologist's office and is most~     commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas~     vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be~     challenging, and the evaluation of vaginitis by physicians is often substandard.~      The investigators will determine whether NAAT testing will improve the diagnosis of vaginal~     infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and~     Trichomonas vaginalis (TV).~   "
65200|NCT02203929|"~     Knowledge of the natural history and progression of macular holes is mainly limited to the~     studies from the pre-optical coherence tomography era. By observing macular holes~     preoperatively we are able to determine the extent of the preoperative macular hole~     progression.~      At our institution macular holes are treated in an elective setting. The majority of macular~     holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation~     followed by vitrectomy.~      We wish to observe the effect of time and cataract surgery on the progression of macular~     holes prior to vitrectomy.~   "
65201|NCT02203916|"~     The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil~     versus placebo in Korean adults with essential hypertension.~   "
65202|NCT02203903|"~     This Phase I dose-escalation trial is designed to evaluate the safety of administering~     rapidly-generated multi-antigen-specific T lymphocytes, to HSCT recipients (group A) or~     future HSCT recipients (group B) for the treatment or relapsed or refractory hematopoietic~     malignancies.~   "
65203|NCT02203890|"~     This study will provide the researchers with an opportunity for the investigation of the~     biomarkers and different human biology component variable interactions in children;~     information that can generate new correlations between markers not known at the moment.~      Regarding their analysis, variation could have multiple connotations. A categorical that~     refers to a specific state, established with a diagnostic standard. And a numerical,~     referring to a range or the absolute value limits in a continuous spectrum; this research~     will allow us to express variability in the distance amplitude of the obtained values level,~     as well as classifications or categories previously established in the possible cases.~      OBJECTIVES PRINCIPAL OBJECTIVE~      To estimate the inter and intra-individual variety in a selected series or biological~     variables determinant of growth, body composition, infection, oxidation, inflammation and~     hydration, in preschool children sharing the same institutional-based diet.~      SPECIFIC OBJECTIVES~        -  To determine the inter and intra-individual variation of growth in preschool children,~          with a similar diet, who attend Secretariat of Beneficial Works of the First Lady~          system daycare centers and to compare between semi-urban and rural.~        -  To describe the inter-individual variation of the red blood cells circulating mass in~          preschool children, with a similar diet, who attend day care centers and to compare~          between semi-urban and rural.~        -  To determine the inter-individual variation of systemic and intraintestinal oxidation~          in preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To describe the inter-individual variation of systemic and intraintestinal inflammation~          in preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To determine the inter and/or intra-individual variation of urinary tract infection and~          gastrointestinal parasite infestation in preschool children, with a similar diet, who~          attend daycare centers and to compare between semi-urban and rural.~        -  To describe the inter and intra-individual variation of the hydration status in~          preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To explore intra-individual associations in variables of the same research component or~          different component variables.~   "
65204|NCT02203877|"~     To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis~     incidence.~   "
65205|NCT02203864|"~     Evaluation of safety and tolerability of four intradermal injections given at two week~     intervals. In addition the efficacy of transferrinfection was determined by quantifying~     Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic~     melanoma cells at the injection sites. Further determination of tumor specific and clinical~     host responses induced or augmented by the treatment were determined.~   "
65206|NCT02203851|"~     The primary objective of the study is to investigate long-term safety and efficacy of BI~     655066/ABBV-066/risankizumab, in patients with moderate to severe chronic plaque psoriasis,~     during open-label treatment.~   "
65207|NCT02203838|"~     This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with~     schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000~     subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting~     clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the~     Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness~     (CGI-S) scale.~   "
65209|NCT02203812|"~     The oral cavity is mostly influenced by general health. The oral microbiota which is as~     complex as the gastro-intestinal or vaginal microbiota are considered to be difficult~     therapeutic targets. The effects of probiotics in different fields of health care have~     resulted recently in the introduction of probiotics for oral healthcare. Probiotics have~     been clinically proved effective in different fields of oral healthcare such as halitosis,~     oral candidiasis and tooth decay. They have also been inducted in the field of periodontal~     healthcare because of the current views on the etiology of plaque- related periodontal~     inflammation.~   "
65210|NCT02203799|"~     Many children who are allergic to peanuts do not outgrow their allergy and have very severe~     allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,~     decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A~     severe allergic reaction can lead to death if not treated appropriately.~      The purpose of this study is to find out if there is a way to treat children with peanut~     allergy to help lower the risk of severe allergic reactions and also cause them to lose~     their allergy to peanuts. The approach that will used for this study is a process called~     desensitization.~      Oral immunotherapy involves eating gradually increasing amounts of a food over several~     months. This is a research study because at this time peanut oral immunotherapy (OIT) is~     investigational. Peanut OIT (study drug) is investigational because it is not currently~     approved for clinical use by the Food and Drug Administration. There are no alternative safe~     and effective treatments for peanut induced allergic reactions other than peanut avoidance~     and treatment with medications.~   "
65211|NCT02203786|"~     To determine if:~        1. pathological gambling is similar to psychostimulant addiction as reflected by parallel~          roles for D1 and D2 receptors in gambling and stimulant reinforcement.~        2. these parallel roles are linked with gambling pathology or if they are evident in both~          gamblers and controls.~   "
65212|NCT02203773|"~     This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of~     orally administered ABT-199 combined with decitabine or azacitidine and the preliminary~     efficacy of these combinations. In addition, there is a DDI sub-study only at a single site,~     to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.~   "
65213|NCT02203760|"~     Study design:~      This study is a prospective, randomized, open-label, multicenter phase II trial in order to~     determine progression-free survival of patients with refractory or relapsed metastatic~     uterine leiomyosarcomas or other metastatic uterine tumours.~      Indication:~      Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas~      Randomization:~      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the~     following therapy~        -  Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min~          d 1 and d 8 q3w or~        -  Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be~          treated according to Arm A.~      Planned number of patients:~      87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas~      Treatment schedules:~      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the~     following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once~     daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or~      • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with~     uterine carcinosarcomas will be treated according to Arm A.~      Planned treatment duration per subject:~      Patients continue on study treatment until disease progression, death, unacceptable toxicity~     or withdrawal of consent for any reason.~   "
65214|NCT02203747|"~     The purpose of this study is to evaluate visual distortions reported by pseudophakic~     patients.~   "
65215|NCT02203734|"~     This project will investigate the effects of massage therapy on depressed pregnant women.~     The investigators expect that massage therapy will improve blood flow from the mother to the~     fetus and reduce prematurity and depression.~   "
65216|NCT02203721|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS~     Symfony Extended Range of Vision IOL.~   "
65217|NCT02203708|"~     Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability~     of interpersonal relationships, self-image and emotions as well as marked impulsivity. When~     patients have children, they are at high risk of severe emotional and relational~     disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). In addition,~     studies support the effectiveness of parental guidance group to reduce emotional and~     behavioral difficulties of children. To our knowledge there are no programs directed to~     mothers with BPD who received a controlled evaluation.~      From experience with parental guidance, data from the observation of children of patients~     with BPD and psychosocial programs directed to patients BPD, we have built for preventive~     intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group~     sessions providing information (education, childcare, care specific to BPD) and promotes~     mother-child interactions (observation, games).~      Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to~     mothers with a BPD in addition to a minimal intervention (diagnostic announcement and~     provision of health care resources) on behavior withdrawal of children at 6 months compared~     to a group of mothers receiving only minimal intervention.~      Primary outcome: Difference at 6 months between the experimental and control groups on~     scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).~   "
65218|NCT02203695|"~     The primary hypothesis of this study is that outcomes for patients with biochemically~     recurrent prostate cancer following radical prostatectomy will be improved by the addition~     of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow~     for further study in the definitive phase III setting. This study builds on the prior~     success of high-dose bicalutamide (for 24 months) when combined with salvage external~     radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter~     duration of time (6 months) in an effort to minimize adverse effects.~   "
65219|NCT02203682|"~     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50~     mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).~   "
65308|NCT02202525|"~     The main purpose of this prospective, multicentre, french observational study is to analyse~     the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive~     patients three months after initiation of a new hypertensive therapy. The PP is defined as~     the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).~   "
65220|NCT02203669|"~     The purpose of this study is to demonstrate the benefits of a structured~     occupational/physical therapy program on upper extremity morbidity for patients who have~     received bilateral breast reconstruction in comparison to a home therapy program and no~     post-operative therapy.~      Hypothesis: Patients who engage in therapist-supervised occupational therapy following~     bilateral breast reconstruction have less upper extremity morbidity than those patients who~     complete a home therapy program or no therapy program.~   "
65221|NCT02203656|"~     The purpose of this study is to test the feasibility of interventions to accelerate recovery~     of muscle mass and function in older adults following acute hospitalization.~   "
65222|NCT02203643|"~     This study will evaluate the safety and the efficacy of carfilzomib combined with~     cyclophosphamide and dexamethasone (CCyd) or lenalidomide and dexamethasone (CRd) followed~     by autologous transplantation ASCT or 12 cycles of carfilzomib combined with dexamethasone~     and lenalidomide for patients eligible for ASCT with newly diagnosed multiple myeloma. As a~     secondary endpoint this study will evaluate the best maintenance treatment between~     lenalidomide and lenalidomide combined with carfilzomib.~      Four hundred seventy-seven patients, males and females aged > 18 years, enrolled in several~     sites, will take part in this study.~      The duration of the study is approximately 5 years.~   "
65223|NCT02203630|"~     Septic shock is a condition that is marked by severe infection causing hypotension requiring~     vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,~     an international organization formed for the purpose of guiding the management of sepsis and~     septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic~     shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as~     an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate~     cardiac complications. This recommendation is based solely on experience with no scientific~     evidence to support this recommendation.~      The investigators will conduct an open-label randomized controlled trial (RCT) directly~     comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used~     in clinical practice for the management of septic shock. The investigators will perform this~     study with a population of patients that have septic shock to complete the following aims:~      Aim 1: Determine the incidence of tachyarrhythmias.~      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a~     lower heart rate.~      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a~     higher incidence of new tachyarrhythmias.~      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less~     time in tachyarrhythmia.~      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with~     fewer complications, including cardiac complications.~      The investigators hypothesize that in this setting, phenylephrine will improve the~     management of septic shock when used as a first choice vasopressor by:~        1. Decreasing the mean heart rate~        2. Decreasing the incidence of new tachyarrhythmias~        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new~          onset and recurrent tachyarrhythmias~        4. Decreasing the number of cardiac complications~   "
65224|NCT02203617|"~     The Baby Books Project tests whether embedding educational information into baby books can~     improve the health and wellbeing of first-time mothers and their young children.~   "
65225|NCT02203604|"~     This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating~     patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies,~     such as aldesleukin, may stimulate or suppress the immune system in different ways and stop~     tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the~     ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with~     ipilimumab may work better in treating patients with melanoma.~   "
65226|NCT02203591|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA~     Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
65227|NCT02203578|"~     This pilot clinical trial studies romidepsin in treating patients with graft-versus-host~     disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an~     effective treatment for graft-versus-host disease caused by a bone marrow or stem cell~     transplant.~   "
65228|NCT02203565|"~     This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in~     patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin~     condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's~     solution may help reduce dermatitis caused by radiation therapy.~   "
65229|NCT02203552|"~     This randomized clinical trial studies how well minocycline hydrochloride works in reducing~     chemotherapy induced depression and anxiety in patients with stage I-III breast cancer.~     Minocycline hydrochloride may prevent changes in memory and thinking and improve the quality~     of life of breast cancer patients receiving chemotherapy.~   "
65230|NCT02203539|"~     The purpose of this study is to determine if an exposure to light in the evening has a~     positive influence on physical performance regarding endurance, strength and reaction time.~   "
65231|NCT02203526|"~     BACKGROUND:~        -  Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma.~        -  The outcome for patients with this diagnosis is significantly worse than for that of~          systemic DLBCL. Most treatment approaches in the past have included high dose~          methotrexate and radiation treatment.~        -  Most PCNSLs appear to be of activated B-cell (ABC) origin.~        -  Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and effective for systemic~          DLBCL of ABC origin.~        -  We propose doing a study in which ibrutinib is combined with a novel chemotherapy~          platform called dose adjusted temozolomide, etoposide, doxil, dexamethasone, ibrutinib,~          rituximab (DA-TEDDI-R).~      OBJECTIVE:~      - Identify the maximum tolerated dose (MTD) of ibrutinib or the dose that achieves adequate~     CSF concentrations, whichever comes first, when ibrutinib is given with DA-TEDDI-R.~      ELIGIBILITY:~        -  Newly diagnosed or relapsed/refractory PCNSL.~        -  Age greater than or equal to 18 years.~        -  No pregnant or breast-feeding women.~        -  Adequate organ function (defined in protocol).~      STUDY DESIGN:~        -  This is a phase 1 study of 40 patients.~        -  The study will have two components.~             1. Phase 1: MTD of ibrutinib will be identified or the dose at which ibrutinib~               achieves a concentration of less than or equal to 100 nM in the CSF, when given in~               combination with DA-TEDDI-R immuno-chemotherapy, whichever comes first.~             2. Expansion cohort: Safety and tolerability of the regimen in relapsed/refractory or~               previously untreated PCNSL (DLBCL type) will be assessed at the final ibrutinib~               dose with DA-TEDDI-R in 10 patients. Secondary objectives will be PFS and OS.~   "
65244|NCT02203357|"~     The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody~     persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine~     with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young~     adults, and the comparative immunogenicity among the three groups will be measured at 1 mon~     post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,~     the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.~   "
66085|NCT02192320|"~     To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative~     treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders~   "
65232|NCT02203513|"~     Background:~        -  All cells go through cycles which allow them to divide. In normal cells, Chk1 and Chk2~          (Chk1/2) stop cell division at various points to allow any damage to DNA to be~          repaired.~        -  When Chk1/2 are not present, cells stop dividing and eventually die. LY2606368 blocks~          the Chk1/2 proteins.~        -  Researchers hope that by blocking Chk1/2, it will cause tumor cells to die, thereby~          shrinking tumors.~      Objective:~      - To see if LY2606368 helps shrink tumors in patients with certain breast, ovarian or~     prostate cancers.~      Eligibility:~      - Patients at least 18 years old with breast or ovarian cancer. They must have a mutation in~     BRCA1/2 genes for group 1, high grade serious ovarian cancer without BRCA1/2 mutation for~     group 2, or triple negative breast cancer without BRCA1/2 mutation for group 3, or prostate~     cancer with or without BRCA1/2 mutation for group 4.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood tests, an electrocardiogram (ECG) heart test, scans, and X-rays. They will have a~          piece of their tumor removed at entry (CT-assisted biopsy).~        -  Study Day 1: Participants will have a physical exam and blood drawn. They may have a CT~          scan of the chest, abdomen, and pelvis.~        -  Day 1 and Day 15 of each 28-day cycle: Participants will receive the study drug through~          an IV.~        -  Vital signs will be checked before and after. An ECG will be done within 1 hour after.~        -  Day 15 and Day 28: Participants will have a physical exam, blood drawn, and a 12 lead~          ECG.~        -  Cycle 1: Participants will have weekly phone calls and blood draws. Participants may~          have another CT-assisted biopsy at the end of cycle 1.~        -  Cycle 2 and beyond, blood will be drawn every other week for routine blood tests.~        -  Participants will have an after-study visit with a physical exam and blood tests.~          Participants may have another biopsy when they progressed on treatment. They will have~          scans of the chest, pelvis, and abdomen and a 12 lead ECG.~   "
65233|NCT02203500|"~     The objectives of this study are to compare the steady state pharmacokinetics of lacidipine~     with and without the co-administration of telmisartan and to compare the steady state~     pharmacokinetics of telmisartan with and without the co-administration of lacidipine~   "
65234|NCT02203487|"~     The objective of the present study was to obtain information about the safety and~     tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary~     pharmacokinetics data (steady state and accumulation factor)~   "
65235|NCT02203474|"~     The primary objective of this study is to demonstrate the superiority of tiotropium~     hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated,~     once-daily dosing.~   "
65236|NCT02203461|"~     Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25)~     after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake,~     measured by hyperinsulinemic euglycemic clamp.~   "
65237|NCT02203448|"~     A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the~     FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to~     Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior~     instrumentation. The objective of this study is to assess outcomes following implantation of~     the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.~      The primary objective of this study is to determine the rate of re-operations at the index~     level(s).~      The secondary objectives of this study are to confirm the safety and performance of the~     device and to collect patient reported outcome data.~   "
65238|NCT02203435|"~     This study aimed to retrospectively examine patients evaluated by the Code Blue team on a~     Code Blue call in our hospital between 2009 and 2013.~      Primary outcome: an examination of the survival rates and demographic data of the patients~     evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to~     determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the~     relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients~     throughout the whole hospital for whom a Code Blue form was completed and who were evaluated~     by the Code Blue team on a Code Blue call.~      Exclusion criteria: patients who refused treatment~   "
65239|NCT02203422|"~     The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known~     hospitals in China. In order to report the efficacy and safety of recombinant human~     thrombopoietin combining with cyclosporin A for the treatment of adults with refractory~     immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.~   "
65240|NCT02203409|"~     The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a~     single center. The validity, feasibility and limitations were assessed objectively through~     our clinical prospective study.The investigators expect laparoscopic ALPPS is safe,~     effective and feasible.~   "
65241|NCT02203396|"~     Severe acquired aplastic anaemia (SAA) is a bone marrow failure disease characterized by~     pancytopenia and a hypocellular bone marrow. The corn pathophysiological mechanism is the~     destruction of hematopoietic stem/progenitor cells mediated by auto-reactive effector T~     cells. Immunosuppressive therapy with horse antithymocyte globulin (ATG) plus cyclosporine~     (CSA) is currently the standard of treatment in patients with aplastic anaemia who are not~     eligible for bone marrow transplantation and with response rates from 40% to 70%. Previous~     studies showed that horse ATG (hATG) is apparently more effective than rabbit ATG (rATG) as~     the latter has higher treatment related mortality (TRM). Unfortunately hATG is unavailable~     in China, so we conduct a optimized standard treatment (9 days protocol) of rATG plus CSA~     and Levamisole (LMS) Sequential maintaining (termed Optimized Standard Protocol, OSP) for~     severe aplastic anemia. This prospective study is designed to evaluate the efficacy and~     safety of Optimized Standard Protocol as first line therapy in newly diagnosed severe~     aplastic anemia patients.~   "
65242|NCT02203383|"~     Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is~     associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed~     with very shallow or absent breathing and is largely due to an exaggerated response to~     rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac~     Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated~     contraction of the heart, has been shown to reduce the severity of CSA in some patient~     groups. We aim to determine whether this improvement is due to normalization of the body's~     response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by~     normalizing the brain's response to carbon dioxide.~   "
65243|NCT02203370|"~     Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM~     Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy,~     Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with~     crossclamped internal carotid artery (ACI). All procedures will be performed in regional~     anesthesia, therefore the patients will be awake and direct neurological examination during~     the procedure will be possible, giving information how the drop in cerebral saturation~     (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical~     symptoms.~      We expect to see a difference in the total drop and in the delay of the drop of cerebral~     oxygen saturation, making it possible to detect varieties in specificity and sensitivity of~     both devices compared to neurologic examination in the awake patient.~   "
65245|NCT02203344|"~     Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes~     in adult intensive care unit (ICU) patients. The revised guidelines for management of pain,~     agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended~     that adult ICU patients should be maintained at a light level of sedation. The key point in~     light sedation strategy is the assessment of depth of sedation. At present, sedation is~     monitored mainly by the subjective clinical score systems, such as the Ramsay Scale, the~     Riker's Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS).~     However, the subjective and intermittent nature of these scales instruments has limited~     their application in light sedation algorithm. Consequently, objective and continuous~     measurement of the level of sedation would be more desirable in clinical practice. In recent~     years, objective measures of brain function have been of great interests in the evaluation~     of sedation level, and bispectral index (BIS) has been the most investigated instrument.~      Several studies compared BIS with subjective sedation scales in adult ICU patients, and~     yielded conflicting results. The different approaches to select BIS value may be the most~     important reason for these inconsistent agreements between BIS and subjective sedation~     scales. A formal scheme of subjective assessment of the depth of sedation and level of~     consciousness should incorporate exerting verbal and physical stimuli and observation of the~     patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS~     in detecting early deep sedation against the reference standard of subjective scale~     instrument. We hypothesize that BIS monitoring will provide accurate, subjective and~     continuous evaluation of deepen sedation.~   "
65246|NCT02203331|"~     Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new~     treatment option for patients with endometriosis-associated pelvic pain~   "
65247|NCT02203318|"~     The aim of this study is to verify whether the hypertrophy of contralateral testis may~     predict the absence of the non-palpable testis in the boys younger than 24months of age.~     According to the previous studies of other countries, the large size of the contralateral~     testis of the nonpalpable testis has positive correlation woth the weak viability of the~     affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups~     are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but~     not normally descended testis group(group2) and control group(group3). The size of testis~     will be measured with Ultrasound and the length, width and the height will be measured~     before surgery at outpatient department. For the group 1 & 2, the viability of the affected~     testis will be evaluated and compared after surgery. In addition the comparison with normal~     control group is also going th be conducted.~   "
65248|NCT02203305|"~     The primary goal of this project is to determine whether subjects with Single-Sided Deafness~     (SSD) experience an improvement in speech perception, localization, and quality of life with~     a cochlear implant as compared to an unaided listening condition.~   "
65249|NCT02203292|"~     TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of~     two red blood cells transfusion thresholds in moderate or severe traumatic brain injured~     patients~   "
65250|NCT02203279|"~     Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and~     6 months of use with mandibular complete dentures. The effect of hard relining materials on~     supporting tissues and patients' satisfaction will also be assessed.~      Materials and Methods: 36 complete edentulous patients who already have maxillary dentures~     and complaining of instable mandibular dentures will be invited to participate in this~     study. Mandibular dentures will be relined randomly by one of three relining materials: two~     chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and~     (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology~     Co, Holland).~      The color stability of relining material, peeling, and the effect on supporting tissue will~     be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition,~     patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS)~     ranging from 0 to 100.~   "
65251|NCT02203266|"~     The purpose of this trial is to discover whether providing feedback to patients from a~     device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:~        -  Improved compliance with prescribed inhaler use~        -  Improved technique of inhaler use~        -  A reduction in respiratory health related outcomes caused by poor inhaler compliance~          and usage.~        -  An improvement in patient quality of life scores~   "
65252|NCT02203253|"~     This study was aimed to evaluate efficacy and tolerability of thalidomide in improving~     prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive~     patients after highly emetogenic chemotherapy.~   "
65253|NCT02203240|"~     The purpose of this study is to determine the impact of consuming cocoa on blood glucose~     levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese~     individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and~     glucose metabolism in subjects at risk for developing type-2 diabetes.~   "
65254|NCT02203227|"~     The purpose of this study is to investigate the efficacy and safety of dietary supplements~     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in~     chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.~   "
65255|NCT02203214|"~     The purpose of this study is to evaluate the safety and effectiveness of the Ligamys~     technique for the treatment of acute ruptures of the anterior cruciate ligament in a~     multicenter routine clinical setting. To conduct a long-term follow-up of the case series as~     a post-market product surveillance endeavor.~   "
65285|NCT02202824|"~     The objective of our study was to determine the extent to which contextual information about~     the circumstances of intimate partner violence affects participants' responses to questions~     about their personal attitudes toward intimate partner violence.~   "
65286|NCT02202811|"~     The purpose of this study is to understand how behaviors and the effects of the body's~     internal clock (called the circadian pacemaker) affect the control of the heart and blood~     pressure.~      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian~     amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced~     circadian phase in some of the same key indices of CV risk. The investigators hypothesize~     that such changes, taken together, may explain the different timing of heart attack and~     sudden cardiac death in OSA.~   "
65256|NCT02203201|"~     The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e.~     celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides~     celiac disease and wheat allergy, there are cases of gluten reactions in which neither~     autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as~     GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion,~     and an elimination diet and an open challenge (i.e., the monitored reintroduction of~     gluten-containing foods) are most often used to evaluate whether health improves or worsen~     with the elimination or reintroduction of gluten in the diet, respectively. In some~     circumstances, it is very difficult to distinguish between NCWS and celiac disease. The~     presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase~     (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the~     diagnosis. However, it is well known that the frequency of a positive serology is dependent~     by the severity of the intestinal damage. Consequently, patients with less severe histology~     damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that~     EmAs are produced by the intestinal lymphocytes and previous data from our group showed that~     EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy~     than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the~     clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the~     culture medium of the duodenal biopsies at the time of the first evaluation, and the~     adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS~     diagnosis based on double-blinded placebo-controlled (DBPC) challenge.~   "
65257|NCT02203188|"~     Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in~     the body. Some of these glands are responsible for providing lubrication for the eye. As a~     result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had~     shown that dry eye symptoms were improved by removing debris and old skin cells along the~     eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this~     study is to determine how well this technique works in improving dry eye signs and symptoms~     in individuals with Sjogren's Syndrome.~   "
65258|NCT02203175|"~     Pain on injection of propofol is a comman problem. The investigators planned to evaluate the~     effect of propofol-fentanyl mixture on propofol injection pain and compare it with fentanyl~     pretreatment and control groups.~      Following ethics committee approval, 150 ASA I,II patients (18-65 yr) undergoing general~     anesthesia were enrolled to this study. Exclusion criteria were communication difficulty,~     psychiatric, neurologic disorders and history of allergy. Patients were randomly assigned to~     one of tree equal groups. Before the anesthesia induction, Group C (Control, n=50) and group~     M (mixture, n=50) received 5 ml isotonic saline, group F (fentanyl, n=50)received 2micgr/kg~     fentanyl. 10 seconds after the study drugs had been given, a standart question about the~     comfort of the injection was asked to the patient. The investigators used the verbal rating~     scale (VRS) for evaluation of propofol injection pain. Statistical analyses were performed~     with Student's t and Fisher's exact tests; p value <0,05 was considered significant.~      Demographic data was similar among the groups (table I) In group M, the number of the~     patients having propofol injection pain was significantly lower compared to groups F and C~     (p<0,001 for both) None of the patients in groups F and M experienced severe pain whereas 24~     patients (48%) had severe pain in group C (p<0.001 for both).~      This study shown that fentanyl-propofol mixture is more effective compared to both fentanyl~     pretreatment and placebo in preventing propofol injection pain.~   "
65259|NCT02203162|"~     Although electronic cigarettes (e-cigs) are now widely used, very little information exists~     regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim~     of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30~     seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.~   "
65260|NCT02203149|"~     This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese~     participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding~     study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose~     determined in Part I in combination with elbasvir. The primary study hypothesis is that the~     percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who~     achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be~     greater than the reference rate of 75%. A separate study arm for cirrhotic participants will~     also be included in Part II; these participants will receive grazoprevir at the determined~     dose in combination with elbasvir.~   "
65261|NCT02203136|"~     The goal of this research study is to improve detection of cancer outside of the bladder~     through genetic testing and improved imaging.~   "
65262|NCT02203123|"~     -  There is no definite tool for measurement of dehydration in children~        -  Subjective clinical dehydration scale is considered as valuable scoring system, but it~          cannot be reliable among clinicians sometimes.~        -  Some authors found Inferior vena cava/Aorta ratio can be a objective marker for~          dehydration~        -  However, there is no evidence of correlation between clinical dehydration scale and~          inferior vena cava/aorta ratio~        -  We will observe correlation between clinical dehydration scale and inferior vena~          cava/aorta ratio and change of the ratio according to hydration with intravenous normal~          saline infusion.~   "
65263|NCT02203110|"~     The purpose of the study is to determine if the clinical course of pneumonia is more severe~     when both, bacterial and viral pathogens are find as possible causative agent and how does~     it affect treatment.~   "
65264|NCT02203097|"~     Purpose:~      The purpose of this study is to examine the effect of different carbon-dioxide~     concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic~     arteries during anesthesia with target-controlled infusion anesthesia using intravenous~     propofol. Propofol is a widely and commonly used intravenous anaesthetic, that is mainly~     used for the induction of general anesthesia and the maintenance of total intravenous~     anaesthesia (TIVA).~      Changes in the velocity of cerebral blood flow and arterial stiffness due to the different~     exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these~     parameters during the course of the narcosis.~      Instruments:~      An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of~     blood flow within a main artery located inside the skull.~      A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the~     radial artery, from which the stiffness of the systemic vessels can be concluded.~      Measurements:~      - Examinations with the ultrasound and tonometry devices are carried out once before the~     operation, three times during the intervention, with different exhaled CO2 values and once~     after the operation is completed.~      Hypothesis:~      - Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries~     during TCI anaesthesia.~   "
65307|NCT02202538|"~     This study will evaluate the Indego® device for safety and effectiveness at allowing persons~     with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of~     conditions.~   "
65265|NCT02203084|"~     Anyone who practices clinical medicine will understand that socially disadvantaged children~     will have worse health outcomes, no matter what the underlying condition might be. There is~     limited prospective data on the effects of social deprivation on children in BC and there is~     none concerning the effects of social deprivation on children with chronic diseases. In~     order to generate relevant data for those who manage children with chronic diseases in BC,~     the investigators wish to perform an observational study of the relationship between~     questionnaire-derived social variables and measured outcomes in children with cystic~     fibrosis, type 1 diabetes, and chronic kidney disease.~      Our working hypothesis is that there is an association between social determinants of health~     (income, education, race) and health outcomes in children with cystic fibrosis, type 1~     diabetes and chronic renal failure, that is independent of access to health care (assessed~     by distance to nearest specialty clinic and number of clinic visits in the last year).~   "
65266|NCT02203071|"~     Subjects will be selected among the investigators' patient population who are already~     scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of~     BioCartilage.~      During the surgical operation for MSP, a portion of the patient's blood is taken out and~     used to form a patch to cover a cartilage defect of the knee. Currently it is considered~     standard of care to either form the patch using only a portion of the patient's blood, or~     form the patch using a portion of the patient's blood combined with an FDA-approved~     augmentation such as BioCartilage.~      This study will collect outcomes data and MRI for patients that are undergoing MSP with and~     without BioCartilage augmentation, then compare the data between those who received~     BioCartilage and those who did not.~      The primary endpoint is to determine whether subjects receiving a marrow stimulating~     procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality~     of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP~     without the use of BioCartilage.~   "
65267|NCT02203058|"~     Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and~     consequent limitations in functional capacity of chronic obstructive pulmonary disease~     (COPD) patients. It has not been completely elucidated whether pursed-lips breathing (PLB)~     is able to minimize DH and its effects on exercise tolerance in these patients. The aim of~     this study was to evaluate the acute effect of PLB on DH and functional capacity in patients~     with COPD.~      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient~     pulmonary rehabilitation program in Florianópolis, Brazil.~      Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%~     predicted, BMI=27.6 (5.13)kg/m2).~      Interventions: Patients will randomly perform two six-minute walk tests with and without PLB~     (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and~     TGlittreNon-PLB).~      Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)~     will be assessed by the slow vital capacity (SVC) maneuver.~   "
65268|NCT02203045|"~     The overall goal of this study is to determine the effects of intraoperative tourniquet use~     during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet~     (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During~     the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower~     extremity while the contralateral lower extremity undergoes TKA without the use of a~     tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are~     commonly used in TKA to improve visualization of the surgical field and limit blood loss.~     However, studies suggest that tourniquet use may be associated with higher rates of medical~     complications and poor functional outcomes, including increased swelling, decreased muscle~     strength and altered neuromuscular activity. We will measure strength, voluntary muscle~     activation, and other functional outcomes for each lower extremity at 4 time points (preop;~     inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize~     that lower extremities in the NOTQT group will demonstrate improved strength and performance~     when compared to lower extremities in the TQT group.~   "
65269|NCT02203032|"~     The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959)~     in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin~     rash) who had inadequate response to ustekinumab.~   "
65270|NCT02203019|"~     Patients with infections in their blood often become very sick. These patients are usually~     put in an intensive care unit for careful observation and treatment. These patients may~     develop a low blood pressure, lung failure, and kidney failure. When these problems develop,~     care becomes quite complicated. Patients with lung failure often need help with a breathing~     machine to make certain that the breathing is adequate. The machine helps keep the oxygen~     level high enough for healthy tissues. When patients are placed on the machine for breathing~     they require a tube to be placed into lungs. This can be quite uncomfortable. These patients~     need sedation to help them tolerate the uncomfortable breathing tube and other parts of~     their routine necessary care. This study will compare two drugs (dexmedetomidine and~     propofol) which are frequently used for sedation in intensive care patients. Clinical~     studies suggest that these drugs are both effective and safe. The main question is whether~     or not one of the drugs is better in a patient with a blood infection. This study will try~     to determine that. Our main goal is to see whether or not patients on one particular drug~     come off the breathing machine faster than patients on the other drug. These drugs are not~     experimental drugs and are approved by the Food and Drug Administration. There is no placebo~     drug being used in this study. All patients in this study will receive the best possible~     care based on their medical condition.~   "
65271|NCT02203006|"~     The purpose of this study is to improve our knowledge concerning HIV infection, treated or~     not, in the current conditions of care to optimize it.~   "
65272|NCT02202993|"~     This is a dose-escalation study that will assess the safety and determine the maximum~     tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium~     channel blocker, combined with hypofractionated radiation therapy (RT) in subjects with~     recurrent glioblastoma multiforme (GBM).~   "
65273|NCT02202980|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of combination~     therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.~   "
65353|NCT02201940|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with~     chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.~   "
65274|NCT02202967|"~     Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used~     commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many~     patients in order to prevent blood clots. Despite their desired benefits, these medicines~     can cause internal bleeding from the digestive system. The source of this bleeding can be~     obvious (overt), or obscure and thought to come from the small intestine. Obscure bleeding~     can show as anemia due to lack of iron in the blood. Small intestine ulcers are now easily~     diagnosed using an endoscope the size of a big pill (video capsule endoscopy). Small bowel~     ulcers are not related to stomach acid and therefore do not heal using remedies usually~     taken to stop acid formation. A different drug, misoprostol, consists of a chemical~     (prostaglandin) that is usually lacking in patients using aspirin or anti-inflammatory~     drugs. Misoprostol is licenced to heal stomach and duodenal ulcers in patients using these~     drugs. Our hypothesis is that misoprostol might be effective in healing small bowel ulcers~     as suggested by pilot studies; however, such works only included small numbers of patients,~     did not include control groups and both patients and investigators knew the nature of the~     tablets used. To test this hypothesis, we propose to compare misoprostol to a dummy tablet.~     The numbers of subjects to be studied have been calculated using established statistical~     methods~   "
65275|NCT02202954|"~     In the situation of motor limitations that people often experience after stroke, current~     health systems cannot provide for the daily amount and duration of high intensity muscle~     stretch and motor training that would be required over protracted periods to involve muscle~     and brain plasticity. For patients with sufficient cognitive abilities, Guided~     Self-rehabilitation Contracts allow implementing stretch and training at high intensity and~     may result in meaningful functional improvement in chronic stages, as long as discipline~     persists over at least a year span.~      This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as~     against conventional therapy in the community, for a one year duration in persons with~     chronic hemiparesis after stroke.~   "
65276|NCT02202941|"~     This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten~     duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.~   "
65277|NCT02202928|"~     The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed~     dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).~   "
65278|NCT02202915|"~     This study examines a training program for clinicians who work in mental health clinics that~     serve children with OCD. We will provide clinician training in conducting exposure-based~     treatments for children with OCD. The purpose of the project is to test the use of a new~     tool to enhance training in exposure-based treatments for clinicians. Therapists will~     receive training and oversight from the researchers regarding the treatment procedures and~     use of the new tool. All children enrolled in the study will receive treatment by clinicians~     who are participating in this study. Therapists and youth will be recruited separately for~     the study and will be assigned to work together.~   "
65279|NCT02202902|"~     This study aims at evaluating the myocardial triglyceride content and cardiac structure and~     function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging,~     in patients with Cushing's syndrome before and after treatment and in age-, sex- and~     BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's~     syndrome patients compared to healthy subjects present with excess lipid storage in cardiac~     myocytes, reversible upon correction of hypercortisolism.~   "
65280|NCT02202889|"~     School based educational intervention to educate on bone health among Hispanic, Asian or~     non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium~     intake and bone density in . The hypothesis was that the educational program would increase~     knowledge, improve dairy food and calcium consumption and enhance bone health in this~     population. A secondary hypothesis was that lactose maldigestion would be an impediment to~     improved dairy food consumption.~   "
65281|NCT02202876|"~     Cystic fibrosis-related diabetes (CFRD) occurs in almost 20% of teens and 50% of adults. The~     investigators' long term goal is to determine the cause of CFRD in order to translate this~     knowledge into therapies aimed at preventing CFRD. Since CFRD and type 2 diabetes share~     several clinical features and since oxidative stress is a key factor in the development of~     type 2 diabetes, the investigators explored the role of oxidative stress in CFRD. The~     investigators discovered a unique CF biochemical signature that they believe could be~     implicated in the development of CFRD. The investigators found that glucose ingestion in CF~     teens and young adults causes an acute and profound systemic redox imbalance to the~     oxidizing state. The degree of redox imbalance was quite severe and would be expected to~     damage the insulin producing cells as these cells are particularly vulnerable to oxidative~     stress. Thus, these findings could prove to be a critical factor in the pathogenesis of~     CFRD. This proposal will test the hypothesis that glucose-induced redox imbalance is an~     intrinsic, metabolic defect in CF. In addition, because CF people are required to consume a~     high calorie diet to maintain their weight, the investigators also hypothesize that certain~     high caloric foods will recapitulate the redox imbalance induced by ingesting glucose and~     thus hasten the development of CFRD. Specifically, the investigators aim to:~        -  Determine whether young children with CF have glucose-induced redox imbalance~        -  Determine whether eating a meal with a high glycemic index induces acute redox~          imbalance~   "
65282|NCT02202863|"~     Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco~     smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and~     fiber, two components of Mediterranean diets, are key functional elements for healthy eating~     and nutrition. We prepared flour from wine grape pomace (WGPF), a rich source of antioxidant~     and fiber, to be used as an ingredient for functional foods and as a dietary supplement to~     increase the intake of dietary fiber and bioactive compounds. WGPF was obtained from red~     grapes (Cabernet Sauvignon variety, Chile). The byproduct of pressing crushed grapes after~     alcoholic fermentation was dried, grounded and stored. The purpose of this study is to~     determine the effects of red wine grape pomace flour intake on glycaemia, plasma lipid~     profile, plasma antioxidants (vitamin C and E), oxidative stress and inflammatory markers.~   "
65283|NCT02202850|"~     Determine which remission criterion at Month 6 predicts remission at Month 12 the best.~   "
65284|NCT02202837|"~     Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life~     Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept~   "
65287|NCT02202798|"~     Over the past 5 years, there has been a change in clinical practice with the use of cuffed~     instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies~     have recently introduced syringe-like devices to the market which allow the measurement of~     the intracuff pressure. This study proposes to prospectively compare the intracuff pressure~     from these devices with the gold standard technique (manometer).~   "
65288|NCT02202785|"~     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in~     patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the~     pancreas.~   "
65289|NCT02202772|"~     The investigators intend to evaluate the safety and toxicity proﬁle of intravesically~     administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment~     refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase~     I trial to assess the safety, toxicity, and efﬁcacy of a novel multidrug intravesical~     regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG~     resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will~     have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.~   "
65290|NCT02202759|"~     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in~     patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of~     the stomach or gastroesophageal junction.~   "
65291|NCT02202746|"~     The purpose of this study is to determine whether lucitanib is safe and effective in the~     treatment of patients with FGF aberrant metastatic breast cancer, as well as in the~     treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.~   "
65292|NCT02202733|"~     The primary goal of the study is to use an iterative process to develop and refine a~     skill-based cooking intervention to decrease the consumption of energy from foods prepared~     away from home for evening meals, decrease energy intake, and promote a healthy weight in~     parents and children aged 3-10 years.~   "
65293|NCT02202720|"~     Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of~     Minimum alveolar concentration of sevoflurane during sedation of patients in ICU~   "
65294|NCT02202707|"~     The purpose of this study is to preliminarily determine whether the frequency and/or~     severity of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with~     gabapentin, relates to various cardiovascular control measures.~   "
65295|NCT02202694|"~     Aim:~      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in~     Pakistan.~      Design:~      Randomized Control Trial~      Setting:~      Psychiatry Departments of General Hospitals in Karachi.~      Participants:~      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a~     psychological intervention or treatment as usual arm.~      Intervention:~      Culturally Adapted Cognitive Behavioral Therapy (CBT)~      Outcome measure:~      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)~   "
65296|NCT02202681|"~     The study is being done to assess the tolerability and feasibility of a tethered OFDI~     capsule to image the duodenum.~      A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake~     and unsedated and ask for their feedback. Images will be taken using the OFDI system while~     the capsule travels from the esophagus into the stomach and into the duodenum.~   "
65297|NCT02202668|"~     The primary translational research objective of the study is to demonstrate feasibility of~     using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This~     study represents an initial evaluation of the device in a small cohort of human patients~     with diabetic foot ulcers. We will be evaluating safety, device design and certain human~     engineering factors associated with point of care use of the TRS. We anticipate the data we~     collect in this study will form the basis of later medical device studies.~   "
65298|NCT02202655|"~     The purpose of this study is to investigate the changes of lymphocyte subsets in~     chemotherapy course of patients with non-small cell lung cancer~   "
65299|NCT02202642|"~     Using collagenase to isolate limbal stem cells and improve the technique of ex vivo~     expansion of limbal stem cells for the treatment of patients suffering from unilateral~     limbal stem cell insufficiency based on the concept of limbal stem cells need special~     cell-cell contact and cell-extracellular matrix interaction to support their survival.~   "
65300|NCT02202629|"~     Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the~     effect of different combinations of plant based extracts on cognitive function and cerebral~     blood flow.~   "
65301|NCT02202616|"~     This is a single cohort, prospective post approval study conducted on patients with COPD in~     Canada. The study will enroll patients that have not responded to their current treatment of~     tiotropium alone, or who are on the fixed dose combinations fluticasone~     propionate/salmeterol. Only patients for whom the physician has decided to change treatment~     due to lack of efficacy will be eligible to be enrolled in the study.~      Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium~     50 mcg) in the management of patients.~   "
65302|NCT02202603|"~     A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and~     Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety,~     tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of~     Entera's oral PTH(1 - 34) in adult healthy human volunteers.~   "
65303|NCT02202590|"~     The goal of this study is to test the feasibility and the tolerability of a tethered~     spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.~   "
65304|NCT02202577|"~     Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior~     to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean~     related surgical site infection.~   "
65305|NCT02202564|"~     HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic~     and extrahepatic portal branches participated in the study. Patients were randomized~     allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All~     patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK~     therapy was delivered to patients twice.~   "
65306|NCT02202551|"~     This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral~     capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD)~     patients with Levodopa Induced Dyskinesia (LID).~   "
65309|NCT02202512|"~     Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed~     by iohexol clearance in healthy male normovolemic subjects after oral administration of~     single and repeated doses of BI 1060469, and BI 1021958.~      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)~     as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after~     oral administration of single and repeated doses of BI 1060469, and BI 1021958.~   "
65310|NCT02202499|"~     The purpose of this Pilot feasibility study is to find out the effect of different~     behavioral treatments along with different duration of a drug called varenicline, on smoking~     behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved~     medication that has been shown to help people quit smoking.~   "
65311|NCT02202486|"~     Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our~     hypothesis that we will test in this study is that the blood-brain barrier breaks down~     during migraine attacks but not out side attacks using MRI.~      Substudy 2 Altered cerebral resting-state functional connectivity networks have been~     reported in migraine patients outside migraine attacks. What happens during migraine attacks~     has never been investigated. The hypothesis we will test is that pain related networks are~     affected during spontaneous attacks using functional MRI.~      Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with~     migraine with aura, but not in those without aura. We hypothesize that CBF is altered~     regionally during attacks, which we will investigate in this study using arterial spin~     labeling (ASL).~      Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been~     suggested but never investigated during migraine attacks. Our hypothesis is that pain~     related structures show altered VBM during spontaneous migraine attacks.~   "
65312|NCT02202473|"~     The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine~     Combination Therapy and whether it could lower the incidence of Lamivudine long-term~     resistance compared to Lamivudine Monotherapy.~   "
65313|NCT02202460|"~     Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and~     MRI.~   "
65314|NCT02202447|"~     The purpose of this study is to determine the safety of EC1169 and the best dose to use in~     humans in future studies. This study will also determine how EC1169 is distributed, broken~     down, passed and absorbed through your body and how quickly it is eliminated (leaves the~     body). All patients will receive EC1169.~      As a secondary objective in Part A: To explore the relationships between baseline PSMA~     expression (tumor and patient level) as measured by 99mTc-EC0652 scans and the antitumor~     activity of EC1169.~      As an exploratory objective in Part B: To assess EC0652 as a predictive biomarker for the~     efficacy of EC1169 by comparing PSMA-positive and PSMA-negative lesions for response.~   "
65315|NCT02202434|"~     The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve~     System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in~     symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     extreme or high risk for surgical valve replacement.~   "
65316|NCT02202421|"~     This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy~     of T-ABA with combined parent training and individual child sessions versus T-ABA with~     individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a~     form of behavior therapy used to promote skill development and reduce disruptive behavior in~     individuals with autism. Four key outcome assessment points will be used: baseline (week 0),~     midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving~     T-ABA parent training only will be offered eight individual therapy sessions at the end of~     the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up~     assessment.~   "
65317|NCT02202408|"~     In this Phase I study, the primary objective is to investigate the safety and tolerability~     of SKI2670 after oral administration in healthy female subjects. And secondary objective is~     to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral~     administration in healthy female subjects.~   "
65318|NCT02202395|"~     The purpose of this study is to investigate the efficacy and safety of~     Hydroxytriptolide(LTS) in active rheumatoid arthritis patients with an inadequate response~     to methotrexate.~   "
65319|NCT02202382|"~     Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.~     However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on~     spermatogenesis has been performed. This study was performed to investigate the effects of~     KRG on semen parameters in male infertility patients in a randomized, double-blind,~     placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele~     were recruited from April 2011 to February 2012. The subjects were then divided into the~     following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;~     non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy.~     Semen analysis was performed and hormonal levels were measured in each treatment arm after~     12 weeks.~   "
65320|NCT02202369|"~     The purpose of this study is to determine if post-operative pain and rate of recovery are~     improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to~     usual analgsic care.~   "
65321|NCT02202356|"~     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect~     of single and multiple doses of ALS-008176 in infants hospitalized with respiratory~     syncytial virus (RSV)~   "
65322|NCT02202343|"~     School based Health and Nutrition Education (SHNE) is a key component of school health and~     nutrition programs that can address several health and nutrition issues in Ethiopia.~   "
65323|NCT02202330|"~     Two thirds of all strokes happen in developing countries like Pakistan. There is a serious~     lack of health literacy regarding survival after stroke. We hypothesize that our set of 5~     minute videos that teach important skills to stroke survivors and their caregivers , that~     can be replayed in cell phones for extended learning, will increase their adherence to~     Medications after stroke and improve the control of blood pressure, elevated cholesterol and~     glucose in the participants getting cell phone based educational videos.~   "
65364|NCT02201797|"~     Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced)~     and DWI MRI can provide valuable information regarding tumor biology and response to~     treatment through various parameters. Validating stability of these parameters will further~     establish robustness and reliability of these promising biomarkers.~   "
65324|NCT02202317|"~     This is a prospective non-blinded case series involving the acquisition of a pair production~     PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic~     malignancy. It will be performed in addition to the standard Brehmsstralung SPECT scan. The~     sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability~     of the scanners at the time. However, it is intended that both be acquired on the day of the~     Y-90 treatment.~      The length of subject participation will be one year.~      The measures used will be mostly qualitative in nature, and will include:~        -  Degree of correlation with expected vs. achieved tumor coverage by the treatment~        -  Degree of correlation between treatment distribution depicted by Brehmsstrahlung scans~          vs. the Internal Pair Production PET/CT scans, to include an assessment/comparison of~          the precision of anatomic localization achieved by the two modalities.~        -  Determination of Tumor/Background ratios, and correlating with planned dose~        -  Detection of non-target embolization, where applicable, and qualitative comparison~          between the two modalities as to the conspicuity of the abnormality~      Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing~     them to the Brehmsstralung SPECT images as previously described.~      Tumor to background ratios will be generated and used as a metric for correlation with~     planned/administered dose and also with CT and/or FDG PET scans pre or post treatment, if~     available. For CT, the RECIST criteria will be used to calculate volumes of necrosis, would~     be used for the correlation. For FDG PET scans, SUV would be used for correlation.~   "
65325|NCT02202304|"~     Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger~     populations. This study wants to investigate if the use of this product would reduce the~     risk of losing abutment teeth on patients that are wearing partial dentures as the~     literature has proven that these teeth are more prone to caries and periodontal disease.~      The primary objectives of this research project are to:~        1. Assess if the topical application of CHX/thymol varnish every three months on partial~          denture abutment teeth results in a clinicallu significant decrease in any loss of~          attachment compared to no application, and~        2. Assess if the topical application of CHX/thymol vanirhs every three months on partial~          denture abutment teeth results in a clinically significant decrease in carious lesion~          development or progression compared to no application.~      The secondary objectives of this research project are to:~      1. Assess of the topical application of CHX/thymol varnish every three months on partial~     denture abutment teeth compared to no application results in a clinically significant~     difference in:~        1. Bleeding on probing (BoP).~        2. Plaque formation.~        3. Periodontal pocket depths.~        4. Microbial composition and GCF cytokine profile of the sub gingival environment.~        5. The patients self perception of oral health.~   "
65326|NCT02202291|"~     Vasospasm is a transient contraction causing a decrease in caliber of a vessel and thus a~     decrease in vascularization in a vascular territory leading to suffering of tissue in the~     sector concerned. Vasospasm-related diseases have different clinical presentations such as~     migraine, spastic angina, hypertension related to vasospasm or primary Raynaud's phenomenon~     (RP). These diseases have few therapeutic methods due to poorly understood pathophysiology.~     For migraine and angina, the vascular exploration is problematic unlike for primary~     Raynaud's phenomenon (RP).~      Primary Raynaud's phenomenon (RP) is a common peripheral vascular disease to cold with an~     estimated prevalence between 5-9 % of the general population. It is the expression of an~     extreme vasospasm microcirculation of the extremities linked to hypersensitivity to cold and~     that is clinically expressed by the occurrence of syncope stages where the fingers are~     anesthetized and white, followed by a stage with hyperemic restaining .~      The objective of our study is to identify new metabolic pathways involved in vasospasm in~     order to consider new specific treatments, currently lacking.~      The identification of these pathways will be made by the detection of genetic abnormalities~     causing vasospasm in Raynaud's phenomenon. This disease is a perfectly appropriate model to~     study vasospasm by its high frequency in the population, its hereditary nature and simple~     diagnosis. The powerful current genetic strategies will be applied to this model (exome~     sequencing combined to family connection analysis).~   "
65327|NCT02202278|"~     The aim of the study is to determine serum oxidative stress status by ischemia modified~     albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative~     stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control~     group. We also aim to reveal the association between serum levels of these factors and~     oocyte quality.~   "
65328|NCT02202265|"~     Background: Cardiovascular diseases are the major health problem worldwide and the~     understanding of genetic contributions on the development of cardiovascular diseases is~     increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of~     LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is~     correlated with increased consumption of total fat. The transcription factor STAT3 is~     released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3~     gene is associated with abdominal obesity and higher intake of saturated fat. Studies have~     been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular~     disease and these dietary patterns have been often studied with nutrigenetic approach; these~     studies, however, are often limited to European populations, making it difficult to~     generalize to different populations.~      Hypothesis: Different dietary approaches may similarly influence in modifying metabolic,~     inflammatory and anthropometric profile, especially among patients with coronary arterial~     disease (CAD). The genetic interaction with environmental factors such as the nutrient~     intake, and the prescription of a different diet according to individual genotype, could~     influence the development and/or the treatment of cardiovascular diseases.~      Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and~     anthropometric profile in patients with CAD and possible interactions with polymorphisms in~     CD36 and STAT3 genes.~   "
65365|NCT02201784|"~     The purpose of this study is to compare the effects of two intrathecally administered~     drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia~   "
65375|NCT02201641|"~     This study aims to investigate the tooth nerve response to a recently introduced therapeutic~     filling material (calcium silicate cement) called Biodentine and to assess the quality of~     the overlying filling compared to another material (glass ionomer cement) called Fuji IX~     used more commonly. Also to compare the effectiveness of cone beam computed tomography~     x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.~   "
65329|NCT02202252|"~     It is not known whether decreasing the number of drains used decreases patients' discomfort~     and duration of hospital stay without increasing seroma formation after mastectomies.~      Hypothesis. Use of one drain increases patient comfort without increasing seroma formation~     after modified radical mastectomy (MRM) as compared to double drains.~      Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and~     Research Hospital will be randomised into single versus double drains groups. A negative~     pressure drain will be inserted below the lower flap directing to the axilla in the single~     drain group or two similar drains will be inserted into the axilla and below the lower flap~     in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma~     is defined as fluid accumulation below the flaps and will be examined daily after the~     operation. One day after removal of the drains seroma under the flaps and in the axilla will~     be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of~     the patients duration of the hospital stay, duration of the drains in place, total drain~     output in the first three days after the operation and the need and frequency of aspirations~     due to seroma formation will be recorded. Patient comfort was measured with a comfort scale~     between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep~     disturbances caused by the drains, The duration of the longer staying drain in the double~     drain group will be recorded for the duration of the drain in place parameter.~   "
65330|NCT02202239|"~     To explore the effect of induction and maintenance of anesthesia with etomidate on~     hemodynamics and oxidative stress in diabetic patients.~   "
65331|NCT02202226|"~     The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after~     repeated oral dosing to patients with schizophrenia.~   "
65332|NCT02202213|"~     The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in~     patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone~     or as added treatment to risperidone).~   "
65333|NCT02202200|"~     An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD)~     evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering~     metastatic melanoma with BR.~      The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added~     to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of~     PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion~     of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.~   "
65334|NCT02202187|"~     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of~     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive~     including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens~     associated with respiratory tract, skin and soft tissue infections including isolates~     resistant to existing classes of antimicrobials. This is a First Time in Human (FTIH) study~     to assess the safety, tolerability, and pharmacokinetics of single oral doses of GSK2140944~     in healthy volunteers. This study will be a single-blind, randomized, placebo-controlled,~     dose-rising study in healthy subjects. The proposed single doses will range from 100 mg to~     3000 mg.~   "
65335|NCT02202174|"~     This purpose of this study is to determine the effectiveness, risk factors, and~     complications associated with use of supraglottic airway devices for primary airway~     maintenance during routine anesthesia in children.~   "
65336|NCT02202161|"~     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for~     14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female~     subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for~     this study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on~     metformin 850 milligram (mg) twice a day (BID). Subjects will then be randomized to~     GSK2330672 10 mg, 20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for~     14 days BID. Subjects will return for a follow-up visit 7-10 days after discharge.~   "
65337|NCT02202148|"~     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum~     Levels Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.~      Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption.~     It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to~     depend on alcohol consumption in alcohol dependent patient, more precisely on the time after~     the last alcohol consumption. This is very few documented after alcohol withdrawal, and has~     never been explored during several months after withdrawal as a function of alcohol~     consumption and abstinence.~      Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis~     and also liver function.~      We propose here to analyse the serum BDNF levels variations after withdrawal according to~     liver stiffness levels and alcohol consumption status.~      We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included~     in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14,~     28 and months 2, 4, and 6.~   "
65338|NCT02202135|"~     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus~     Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft~     tissue infections.~   "
65339|NCT02202122|"~     Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the~     prognosis of postoperative mortality after femoral neck fracture.~   "
65340|NCT02202109|"~     The study will test the significance of community health worker (CHW) participation by~     comparing self-sampling provided by a community health worker and self-sampling provided by~     mail. The study will enroll 700 participants in communities that lack access to medical care~     in South Florida.~   "
65341|NCT02202096|"~     The primary hypothesis is that a comprehensive transitional care program based on the~     premise of a patient-centered medical home versus routine care reduces emergency room visits~     and hospital readmissions without increasing costs among cancer patients undergoing surgery~     at a large safety-net hospital.~   "
65342|NCT02202083|"~     Currently, the study about intervention on the induced abortion at trimester is so little.~     So, the investigators want to compare the safety and effectiveness of different induced~     labor.~   "
66086|NCT02192307|"~     This study will compare the safety and effectiveness of two water-based potassium oxalate~     desensitizers on existing dentinal hypersensitivity.~   "
65343|NCT02202070|"~     Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated~     with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter~     muscle hyperactivity and spasm~      This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain~     disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint~     disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units~     Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.~      The objective of the proposed study will be to establish the safety and efficacy of botox in~     treating TMD associated with bruxism. By the time patients reach the specialists office,~     most have failed maximal conservative therapies, including non-chew diet, night guard, oral~     analgesics, muscle relaxants, physical therapy, and a portion have even undergone more~     invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty~     surgeries with limited improvement or recurrence. Primary outcome of the study will be 50%~     reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25%~     increase in maximal inter-incisal opening (MIO). The investigators look forward to working~     with you on the proposed study~   "
65344|NCT02202057|"~     The purpose of this study is to determine whether people with Parkinson's disease (PD)~     experience reduced perception of respiratory resistive loads versus healthy adults in the~     same age group. Further, the study will determine whether people with PD and trouble~     swallowing experience even more reduction of their perception of a respiratory resistive~     load.~   "
65345|NCT02202044|"~     The primary objective of the study is to assess the bladder cancer recurrence free rate,~     according to a phase II pilot study, of intravesical instillation of sequential BCG and~     EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure~     is disease recurrence rate. Follow up will continue up to 5 years.~      For sample size determination, disease recurrence rate will be compared with literature data~     of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).~   "
65346|NCT02202031|"~     We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation~     therapies in 160 ambulatory women who report an average of at least 3 urgency-associated~     voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:~     1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at~     least 15 minutes/day at home using a portable guided-breathing device; or 2) use an~     identical-appearing device that plays relaxing music while monitoring their spontaneous~     breathing pattern. We do not know if either of the two types of relaxation therapies is~     effective in treating OAB. All women will also receive a usual care pamphlet providing basic~     information about other traditional self-management strategies for OAB.~   "
65347|NCT02202018|"~     Patients with severe kidney failure require dialysis or transplantation to survive. For~     those in whom a transplant is not an option, there are two main dialysis options:~     hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies~     (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with~     the proportion of home-based therapies varying between 10 and 40% across centres. Studies~     show that the low use of home dialysis is due to a variety of factors, though patient and~     provider awareness and knowledge of home dialysis are major factors. In this cluster~     randomized trial, the investigators will determine whether a standardized modality education~     program directed at patients, in combination with a provider-directed intervention, can~     increase the use of home dialysis in incident dialysis patients in Canada.~   "
65348|NCT02202005|"~     The objective of this steady state pivotal study is to compare the rate and extent of~     absorption and to evaluate Bioequivalence of test drug compared to the approved reference~     product in HIV infected individuals~   "
65349|NCT02201992|"~     This randomized phase III trial studies how well crizotinib works and compares it to placebo~     in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by~     surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations,~     or changes, in ALK can make it very active and important for tumor cell growth and~     progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from~     working. Crizotinib may be an effective treatment for patients with non-small cell lung~     cancer and an ALK fusion mutation.~   "
65350|NCT02201979|"~     Breast lift surgery performed in combination with breast implants is a common cosmetic~     operation. However, there have been concerns regarding the safety of this treatment~     combination. Some investigators are concerned that an implant may increase the risk of~     complications, including loss of circulation to the nipple and areola. This study was~     undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent~     imaging and to determine whether a breast implant compromises blood supply to the nipple and~     areola.~   "
65351|NCT02201966|"~     Low back pain is a common condition in children who perform gymnastics. Commonly, the injury~     is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional~     interdependence is a theory that suggests when adjacent joints and muscles are not working~     properly increased stress is placed on a particular joint. This theory would suggest that if~     a patient did not have enough hip extension to perform a back bend increased motion would~     occur in the lumbar spine allowing the gymnast to complete the technique. Currently, no~     research links impairments in other joints to low back pain in gymnasts.~      This is a cross sectional study assessing the relationship between gymnast with back pain~     and flexibility and strength of the shoulder and hip joints. Investigators will travel to a~     local gymnastics training centers and assess the gymnasts' strength and flexibility of the~     the hips and shoulders. The gymnast will also fill our a questionnaire assessing if they~     have had back pain in the past month and how much has it limited their ability to~     participate in gymnastics. Investigators will be blinded to the results of this survey.~      The goal of this research study is to see if there are any link between strength and~     flexibility of the hips, and shoulders and gymnasts with low back pain. The investigators~     hypothesize that gymnasts who demonstrates impairments in strength and flexibility of the~     hips, or shoulders will be more likely to have complaints of low back pain.~   "
65352|NCT02201953|"~     The primary objectives of this study are to compare the efficacy of treatment with~     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of~     sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability~     of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV)~     infection.~   "
65354|NCT02201927|"~     Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients~     suffering right posterior parietal lesions fail to update their own position after a body~     rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal~     cortex and reduces symptoms of spatial neglect, another disability frequently encountered~     after right posterior parietal lesion. The aims of this study are to confirm posterior~     parietal involvement in automatic updating of body-centered spatial relationships and to~     evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three~     groups of adults are compared before and during galvanic vestibular stimulation on a~     pointing task: a healthy control group, a brain-injured control group with stroke lesions~     sparing right posterior parietal cortex and a group of stroke patients with right posterior~     parietal lesions.~   "
65355|NCT02201914|"~     Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating~     condition, due to its poor prognosis in terms of chances of pregnancy and live births.~     Various ovarian stimulation regimens have been tried to overcome these obstacles. A simple~     approach is increase the dose of the gonadotropin administration, but the results in terms~     of pregnancy rate are very low Another commonly used stimulation regimen is the microdose~     GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins~     that follows the agonist administration in the early follicular phase and subsequently~     prevents a premature LH surge, with fewer cycle cancellations. However, their application in~     poor responders, even if in small doses and for a limited period, has been questioned as~     they may cause oversuppression of ovarian function, leading to a prolonged cycle and~     increased treatment costs without improving the outcomes.~      Recently, GnRH antagonists were introduced in ART treatment. They are effective in~     preventing a premature LH surge and allow for a more natural recruitment of follicles in the~     follicular phase in a non-suppressed ovary, offering a potential alternative in the~     treatment of these patients. However, randomized studies evaluating the efficacy of this~     regimen in poor responders did not show any improvements in pregnancy rates. Current~     approach have included the addition of oral agents such us clomiphene citrate (CC) to~     gonadotropins. Some authors have investigated the role of CC in addition to low dose of~     gonadotropins in mild stimulation regimen, demonstrating that, despite a small number of~     retrieved oocytes, good quality embryos were produced with a subsequent improvement in the~     fertilization rate, clinical pregnancy rate and live birth rate. The only study that~     evaluate the efficacy of CC in addition to high doses of gonadotropins in poor responders~     showed improving in number of retrieved oocytes, transferred embryos and biochemical~     pregnancy; however, clinical pregnancy rate and live birth rate remained low and showed no~     measurable increase.~      The aim of this study was to compare the efficacy of the CC as an adjunctive to a high dose~     of gonadotropins in cycles with antagonist protocols with the microdose GnRH agonist and~     flexible antagonist protocols in women who responded poorly to ovarian stimulation, to~     determine whether this protocol may improve IVF outcomes, offering a valid alternative in~     poor responder patients treatment.~   "
65356|NCT02201901|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without~     ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C~     virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.~   "
65357|NCT02201888|"~     Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence~     suggests has consequences for functional adaptation and which cause difficulties in social~     re-integration after hospitalization. The investigators propose a large scale, multicentric~     study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed~     at answering outstanding questions concerning the effectiveness of cognitive estimulation~     therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)~     issues related to the size of the effect compared to treatment as usual and compared to a~     control intervention; b) generalizability of improvement to cognitive function and social~     cognition in daily life; and c) the durability of therapeutic gains after the end of~     treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three~     treatment conditions: a computer- assisted cognitive estimulation program (n=64),~     non-structured time on computer (n=64) and treatment as usual (n=64). A battery of~     neurocognitive tests of memory and executive function, including 'ecologically valid'~     measures, will be administered by blind evaluators at baseline, after 6 months of cognitive~     estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem~     will be also be assessed at baseline, after the treatment and at follow-up.~   "
65358|NCT02201875|"~     We made a fortuitous observation of periodic breathing in a healthy subject coming to our~     outpatient mountain medicine consultation at Avicenne hospital in Bobigny (France). During~     this consultation, subjects perform a hypoxia exercise test, which allows a good prediction~     of their risk factors for severe high altitude illnesses. Surprisingly, breath-by-breath~     recording of the ventilation signal showed a periodic breathing pattern, which increased~     when the subject started to exercise in hypoxic conditions and was maintained during~     normoxic exercise.~      Therefore, our objective was to confirm this observation in a retrospective study led in 82~     subjects who passed this test. We tested the hypothesis that subjects with a brisk~     ventilatory response to hypoxia might show a more pronounced periodic pattern of~     ventilation, due to a higher gain of the chemoreceptor feedback loop. Then, our objective is~     to investigate the mechanisms involved in the periodic pattern in healthy subjects, as a~     function of exercise intensity, altitude intensity, role of peripheral and central~     chemoreceptors to O2 and CO2. Finally, we want to investigate the possible role of this~     ventilatory instability in patients with obstructive or central apneas.~   "
65359|NCT02201862|"~     This study is being conducted to provide clinically annotated samples to support continued~     improvements in the Ariosa Test content, methodology, specimen processing and quality~     control.~   "
65360|NCT02201849|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a~     monomethyl fumerate (MMF) molecule.~   "
65361|NCT02201836|"~     The onset of asthma is particularly frightening for children. When the symptoms of asthma~     decrease, children and parents forget about the maintenance and control of breath and lung~     volume. Because adherence is so poor, asthma is known as the emergency room illness. The~     playing of a wind instrument is a unique way to provide a creative means for children and~     teens to understand both the impact of diaphramatic breathing and their ability to control~     it as well. This study builds upon the evidence, though sparse, that suggest that the~     blowing of a wind instrument with clinical music therapy intervention strengthens the~     muscles of breathing and fortifies the incentive toward attending to the daily symptoms and~     general management of asthma.~   "
65362|NCT02201823|"~     Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new~     drug, ABTL0812, that will be administered orally daily to patients with advanced solid~     tumors.~   "
65363|NCT02201810|"~     This study is a randomized clinical trial designed to measure the effectiveness of three QL~     interventions for smokers who failed to quit an initial smoking cessation intervention, but~     remain motivated to quit smoking.~   "
66087|NCT02192294|"~     This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period~     crossover study in healthy subjects.~   "
65366|NCT02201771|"~     The study population will include all patients undergoing elective CABG. Consent and~     randomization will occur before surgery. Total 500 patients undergoing elective CABG will be~     randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this~     open-label study. All the enrolled patients will stop oral antiplatelet drugs according to~     local protocol before the surgery. Within the first 24 hours after surgery, study medication~     should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs~     by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving~     ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet~     drugs by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time~     patients will undergo a multislice computed tomography angiography to assess vein graft~     patency.~      This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as~     compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of~     vein graft patency.~   "
65367|NCT02201758|"~     This study proposes to examine the effect of diet as a modifiable risk factor among patients~     with ulcerative colitis (UC). Flax seeds contain many bioactive constituents which have~     anti-oxidative, anti-inflammatory, and anti-carcinogenic effects. These bioactive compounds~     represent novel classes of pharmacologically active compounds which may represent new~     options to treat chronic disease of the gastrointestinal tract. Participants with mild to~     moderately severe UC will supplement their current medications with flaxseed lignan-enriched~     complex (FLC). This is a 12 week double blind placebo controlled study with assessment~     throughout. Stool and blood samples (biomarkers) as well as bowel assessment via~     sigmoidoscopy will be evaluated before and after the intervention. The treatment arm~     consists of 300 mg FLC taken orally twice daily.~   "
65368|NCT02201732|"~     The purpose of this study of is to compare subsequent fertility rates between hysteroscopy~     and aspirative curettage in the surgical treatment of incomplete spontaneous abortion~   "
65369|NCT02201719|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been~     correlated with adenomyosis.~      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as~     local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune~     and mechanical factors are also hypothesized.~      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic~     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin~     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation~     have been tried, but studies are few in number, retrospective, and have small sample sizes.~      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of~     adenomyosis remains still unclear, there are not many satisfying treatment options and~     diagnostics include mostly magnetic resonance imaging (MRI) and histology.~      The investigators designed a series of 3 studies with a broad approach in understanding~     adenomyosis. This is part 1.~      NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic~     of adenomyosis~   "
65370|NCT02201706|"~     Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a~     complex retinal detachment with poor prognosis.~      In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation~     retinectomy to reattach the retina. Here the investigators aimed to explore the safety and~     efficacy of this new surgical approach~   "
65371|NCT02201693|"~     The purpose of this study is to compare the rate of first relapse at 12 months between~     maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily~     calories) and maintenance therapy with supplementary enteral nutritional support (25% daily~     calories).~   "
65372|NCT02201680|"~     1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.~        2. Several factors defined to effect the anxiety levels preoperatively in children such as~          , age, previous medical encounters , education level and parental anxiety. 3. This~          information was tested for Turkish children during the preoperative anesthetic~          evaluation.~   "
65373|NCT02201667|"~     The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial~     blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been~     documented as being the most effective method for restoration of epicardial blood flow.~     However, epicardial blood flow does not necessarily equate to myocardial perfusion.~     Clopidogrel binds irreversibly to platelet P 2 Y 12 receptors to inhibit platelet~     aggregation, with main limitations of slow onset, prevention of recovery of platelet~     functions, and interindividual variability. Clinical pharmacology and early dose-finding~     studies suggested a faster onset and greater and more consistent inhibition of platelet~     aggregation (IPA) with ticagrelor compared with clopidogrel. Two currently main methods of~     angiographic assessment of myocardial perfusion includes thrombolysis in myocardial~     infarction(TIMI) myocardial perfusion grading (TMPG) and myocardial blush grading (MBG).~     These established myocardial perfusion parameters have been widely used in various important~     trials and are reported to be highly useful in predicting clinical outcomes. However, visual~     assessment of these methods is categorical, subjective, and operator dependent of contrast~     in the myocardium using cine-angiographic frame-counting, was developed by the~     investigators' center to quantify myocardial tissue- level perfusion and was proved to be a~     predictive value on clinical prognosis.~      Thus, the investigators aim to initiate an open-label study evaluating the acute efficacy of~     treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed~     by Myocardial Perfusion Frame Count(TMPFC) and magnetic resonance imaging (MRI) in patients~     with high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing early~     percutaneous coronary intervention (PCI) .~      The investigators hypothesize that compared with clopidogrel, ticagrelor can significantly~     improve myocardial perfusion assessed by Myocardial Perfusion Frame Count(TMPFC) in~     high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) patients undergoing early~     percutaneous coronary intervention (PCI), without additional increased major bleeding.~   "
65374|NCT02201654|"~     This research study compares two ways to biopsy lymph nodes in the chest using endobronchial~     ultrasound-guided transbronchial needle aspiration (EBUS-TNBA). During a EBUS-TBNA~     procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted~     through the mouth into the large airways of the chest, allowing us to see (via ultrasound)~     and biopsy the lymph nodes in the chest.~      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made~     simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2)~     an inner stylet that runs through the middle of the needle. Because many other biopsy~     needles (such as the needles used in breast biopsy and different types of lung biopsy~     needles) do not use an inner stylet, the investigators do not think the use of a stylet is~     necessary. If this step can be safely eliminated without decreasing the effectiveness of the~     procedure, this could shorten the procedure (saving time). This study is deigned to formally~     test the hypothesis that a stylet is not necessary in EBUS-TBNA.~   "
65376|NCT02201628|"~     Children lose heat under general anaesthesia, thus temperature is routinely monitored during~     anaesthesia for all but the shortest cases, and active warming can be used to prevent~     hypothermia and its resulting complications. Temperature can be measured at several sites~     dependent on the type of surgery and patient factors. Previously a temperature probe has~     been sited in the lower third of the oesophagus (swallowing tube) but it is difficult to~     accurately place this without an X-Ray. Consequently it is more common to use a temperature~     probe placed in the nasopharynx (where the nose and throat meet), when the child is~     anaesthetised.~      However the investigators do not know if the temperature in the nasopharynx correlates well~     with the real core temperature or not.This prospective, unblinded, agreement study will seek~     to find an agreement of 2 methods to measure temperature in children undergoing general~     anaesthesia with a breathing tube that has a leak.~   "
65377|NCT02201615|"~     Objective To examine the effects of perineal massage applied during the action of birth on~     the frequency of episiotomy procedures, perineal tearing and the duration of the second~     stage of birth.~      Methods The present study was a randomized controlled experimental. Women (284 women) were~     informed on the study and provided their written consent. 10-minute perineal massage with~     glycerine was applied to the women in the test group for 4 times during the first stage and~     1 time in the second stage of birth. The women in the control group received the routine~     care procedure at the clinic.~      Results According to the study findings, 31% of the women in the test group and 69.7% of the~     women in the control group were made subject to episiotomy (p<0.05). In the test and control~     group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The~     average duration of the action of birth was 25.33 minutes in the test group and 28.18~     minutes in the control group (p<0.05).~      Conclusion The study results indicate that perineal massage applied during the action of~     birth decreased the rate of episiotomy procedure and shortened the duration of the second~     stage of birth.~   "
65378|NCT02201602|"~     Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes~     mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.~   "
65379|NCT02201589|"~     The purpose of this study is to investigate the outcome of patients with pathologies of the~     ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from~     the heart) including type A aortic dissection, retrograde type A aortic dissection,~     intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular~     (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician~     Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a~     condition where blood passes through the inner lining or between the layers of the blood~     vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type~     A aortic dissection is a condition where the dissection or tear in the ascending aorta~     starts from the descending aorta; an intramural hematoma is a collection of clotted blood~     within the aortic wall; a penetrating ulcer has a plaque or clot within the wall and a~     pseudoaneurysm is a false aneurysm . If left untreated in any of these conditions, the aorta~     can enlarge and rupture causing injury or death. The plan for these patients is to repair~     the ascending thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the~     Captivia Delivery System. The Valiant Captivia has been evaluated worldwide and used~     extensively in patients with type B (descending) thoracic aortic dissection. Since the~     dissections in the ascending aortas mirror that of the descending aorta, it is expected that~     this stent graft will deliver similar performance and endurance in patients with type A~     aortic dissection. The investigators expect to reroute the blood to the true lumen (the~     inner space within the blood vessel) by covering the proximal (nearest to the heart) tear~     with the stent graft. The stent graft is a stent frame made from Nitinol wire and covered~     with an expandable material made of a polyester material. This new study will determine how~     well the device works to treat dissections, intramural hematomas, penetrating ulcers and~     pseudoaneurysms in the ascending thoracic aorta.~   "
65380|NCT02201576|"~     The purpose of the study is to assess the efficacy of bortezomib, in association with~     steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of~     chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney~     transplant recipients~   "
65381|NCT02201563|"~     Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic~     brain tumors. Although SRS has a very high tumor growth control these interventions are~     associated with adverse radiation effects (ARE) in approximately 15 % of patients. The~     traditional approach, and still a mainstay, is the administration of a course of high dose~     anti-inflammatory corticosteroids. Currently there are no other effective oral~     neuroprotective agents in clinical practice which can improve outcomes of patients with ARE~     after radiosurgery for brain metastases.~      Minocycline, an antibiotic with a favorable adverse effect profile and pharmacokinetics, has~     been shown to have neuroprotective properties in experimental models of a variety of~     neurological diseases, as well as in human clinical trials. The investigators propose a~     single arm clinical trial, to evaluate the safety and feasibility of minocycline in~     improving ARE. This study will recruit 15 patients who will be treated with minocycline~     (100mg BID) for 3 months. This clinical trial has the potential to prove that minocycline~     therapy is safe in this patient population. In addition, positive results will provide~     preliminary evidence for its use in an array of radiosurgical indications.~   "
65382|NCT02201550|"~     The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on~     the immune system i.e on the regulation of immune cells important in diseases such as~     obesity and diabetes.~      The hypotheses are:~        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells~          in the blood~        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the~          blood~        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine~          profile in the blood~   "
65383|NCT02201537|"~     The hypothesis of our study is that a correlation exists between the couple ultrasound~     elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of~     fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as~     elastography alone did not allow to differentiate moderated fibrosis at 3 months in our~     feasibility study.~   "
65384|NCT02201524|"~     Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842~     in patients with moderate to severe psoriasis. The study will include three PF-04965842~     groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The~     treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up~     period.~   "
65385|NCT02201511|"~     The study is designed to understand the blood concetration of PF-06412562 and its~     metabolite, PF-06663872, following a single oral dose of a modified release formulation. The~     study will include two doses of the PF-06412562 modified release formulation to understand~     the proportionality. Effect of food on absorption of PF-06412562 from the modified release~     formulation will also be investigated in this study.~   "
66088|NCT02192281|"~     The purpose of this study is to determine whether Playworks has an impact on student and~     school outcomes such as physical activity, behavior, and academic performance.~   "
65387|NCT02201485|"~     Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small~     hepatic veins to the confluence between inferior vena cava and right atrium, which often~     leads to the life-threatening complications, such as liver failure and portal~     hypertension-related complications. At present, a stepwise treatment strategy is employed,~     including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous~     transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular~     intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of~     BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization~     is the most common treatment modality used in China.~      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has~     shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with~     stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as~     the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might~     have a worse survival than PTA combined with stent placement in Chinese patients with~     primary BCS.~   "
65388|NCT02201472|"~     MRI & MRE in infants~   "
65389|NCT02201459|"~     This is a phase III trial comparing, for newly diagnosed chronic phase CML patients,~     nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa~     2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses~     for a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the~     primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is~     the rate patients obtaining MR4.5 will be measured at this time point.~   "
65390|NCT02201446|"~     Efforts to identify circulating factors that predict severity of acute lung injury/acute~     respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this~     study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS~     biomarker.~   "
65391|NCT02201433|"~     Breastfeeding is recommended for preterm infants. Development of breastfeeding is an~     important issue, requiring the involvement of medical and paramedical staff in neonatal~     units. There are few data concerning the fathers of preterm infants. However, the role of~     the father is identified in the literature as a key factor in the initiation and~     continuation of breastfeeding. In our neonatal unit care, reasons for breastfeeding high~     rates are not identified but may be related to the father being in close and constant~     contact with the medical and paramedical staff. In fact, fathers are often first in contact~     with caregivers. They can be invested in the implementation of nursing care, skin to skin,~     as well as being asked to support the development of their child in the service and at home.~      The aims of this study are to:~        -  Analyze the beliefs, social representations and the experience of the fathers of~          premature infants hospitalized in intensive care unit concerning breastfeeding.~        -  Analyze the factors facilitating and inhibiting the initiation and continuation of~          breastfeeding.~        -  Consider strategies of care and support that can be used for the families of premature~          infants and of children born at term.~        -  Explore the expectations of medical staff with regards to the management of children~          and families, their practices, identify the role attributed to the father.~        -  Initiate and facilitate reflexivity of medical and paramedical staff about their~          respective practices~   "
65392|NCT02201420|"~     The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc~     99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This~     is a single center, open-label, within-subject study.~   "
65393|NCT02201407|"~     This open-label, multicenter, national observational study will investigate the~     effectiveness of standard of care treatment with PEGASYS in patients with chronic hepatitis~     B (CHB). Patients who have never received any hepatitis B virus (HBV) treatment and patients~     previously treated with nucleos(t)ide analogs are qualified for enrollment. The observation~     period is 48 weeks (PEGASYS standard of care treatment) and for up to 24 weeks thereafter~     (72 weeks in total).~   "
65394|NCT02201394|"~     ACS patients treated with antiplatelet drugs who require CABG surgery have to wait 5-7 days~     for the effects of the drugs to wean off. This treatment-devoid period leaves the patient~     vulnerable, therefore any means to shorten this period could be useful. The present study~     aims to investigate the possibility of reversing the antiplatelet effects of ticagrelor with~     the help of fresh donor platelets. Fresh platelets will be added to blood samples of treated~     patients in varying concentrations at specific timepoints to determine the time and amount~     of fresh platelets needed to normalize platelet reactivity in the treated samples.~   "
65395|NCT02201381|"~     The purpose of this study is to determine the effectiveness of a regimen of selected~     metabolic treatments for patients with cancer in a real world setting and to conduct~     exploratory analysis on the relationship between the degree of response and changes in~     biochemical markers (such as glucose and lipid levels).~   "
65396|NCT02201368|"~     The purpose of this study is to determine if administration Triheptanoin is an effective~     treatment for defects of the long-chain fatty acid beta-oxidation in young adults or adults.~     Period of treatment and follow-up will be 16 months.~   "
65397|NCT02201355|"~     Primary Objectives:~      To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx,~     hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks~     using reduced volume IMRT~      Secondary Objectives:~      To describe the adverse events associated with hypofractionated, reduced volume cisplatin~     chemoradiation.~      To estimate response rates and progression-free survival rates of hypofractionated, reduced~     volume cisplatin chemoradiation.~      To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.~      If patients can safely be treated in three weeks rather than six weeks, such a schedule~     would provide a much more convenient alternative for patients and result in a significant~     reduction in the health care resources currently expended on cure of these patients.~   "
65398|NCT02201342|"~     To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan~     physiology and to assess the short-term pharmacodynamic effect of udenafil on~     pharmacodynamic measures of exercise capacity, ventricular performance, and vascular~     function.~   "
65569|NCT02199093|"~     The purpose of this study is to analyze the effects of a mixed intervention of occupational~     therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and~     moderate patients post stroke in comparison to a control group with a traditional health~     educative protocol.~   "
65399|NCT02201329|"~     To identify the maximum tolerated dose or recommended dose for further development of~     volasertib in combination with azacitidine in Japanese patients with myelodysplastic~     syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability,~     pharmacokinetics and the preliminary efficacy of this combination.~   "
65400|NCT02201316|"~     This study aims to determine the relative bioavailability of two candidate formulations of~     mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate~     5mg) from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an~     open-label, randomised, single dose, three-way crossover, six sequence study. Subjects will~     receive a single oral dose separated by at least 7 days and no greater than 14 days washout~     period. This study is required to select a candidate mosapride citrate (GR107719B)~     formulation for further development and provide data to allow the design of a future pivotal~     bioequivalence study. The candidate formulations will be compared with the innovator~     GASMOTIN. GASMOTIN is a trademark of Dainippon Sumitomo Pharmaceutical Company.~   "
65401|NCT02201303|"~     This study is to determine danirixin (GSK1325756) concentrations required to inhibit~     neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected~     children <2 years and healthy adults. The study will evaluate differences in neutrophil~     activation between RSV-infected children <2 years and healthy adults with escalating~     concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if~     RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited~     by danirixin. This study will guide dose prediction to inhibit specific percentages of~     neutrophils in future pediatric RSV-infection studies. This single-center, in vitro study~     will consist of 2 parts. Approximately 24 subjects will be enrolled, including 12 healthy~     adults and 12 RSV-infected children <2 years.~   "
65402|NCT02201290|"~     This is an open-label Phase III extension study to evaluate the long-term safety of~     eltrombopag in pediatric patients with chronic ITP who previously participated in study~     TRA115450. This study will allow dosing of eltrombopag at an individualized dose for each~     subject based upon platelet count. The starting dose will be based on the subject's dose at~     the end of the TRA115450 study. The maximum dose will be 75 mg daily.~   "
65403|NCT02201277|"~     This research study is a prospective randomized trial evaluating the relative safety of two~     inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous~     deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All~     eligible patients will have been ordered to have a IVC filter placed by their primary~     medical team and filters will be placed in these patients whether or not they wish to~     participate in this trial as part of standard of care. The investigators will follow up with~     patients 30 days after IVC filter placement and ask them to come back for filter removal if~     medically appropriate. If removal is not medically appropriate in 30 days, the investigators~     will attempt to schedule removal every 30 days after initial placement.~      Primary outcome measures will be IVC filter complications such as filter penetration through~     the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots~     formed within the filter. All of these are reported complications of all IVC filters.~      The research also aims to improve the standard of care for IVC filter patient follow up as~     the FDA and Society of Interventional Radiology recommend that IVC filters be removed as~     soon as it is safe to do so.~      Hypothesis:~      The investigators hypothesize that there is no significant difference in efficacy and~     complication rate between the Option and the Denali filter.~   "
65404|NCT02201264|"~     The proposed study is a registry of patients treated with primary angioplasty for acute~     myocardial infarction.~      The aim of this registry is to define the outcomes of patients treated for acute, ST-segment~     myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery~     programs that have completed the C-PORT Primary Angioplasty Development program. The primary~     medical outcome for the registry is the combined incidence of death, recurrent non-fatal~     myocardial infarction and stroke.~   "
65405|NCT02201251|"~     The purpose of this study is to evaluate the safety of topiramate monotherapy compared with~     levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or~     recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone~     mineralization, and kidney stone formation in children aged 2 to 15 years.~   "
65406|NCT02201238|"~     This research study is being conducted to characterize the pharmacokinetic properties of a~     new topical medication (MFC51123) that contains two active ingredients (diclofenac and~     menthol) in two formulation packages. One formulation package is in the form of a gel in~     aluminum tube and the other one in the form of a gel in roll-on applicator bottle.~     Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel~     and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol~     gel has being developed to treat mild to moderate pain and inflammation, such as acute sport~     injuries, sprains and strains. The rationale for conducting the study is to prove that~     repeated topical treatment of the new diclofenac + menthol formulation in either of the two~     packages does not result in unsafe systemic exposure.~   "
65407|NCT02201225|"~     This methodology study will evaluate the sensitivity in using sitting knee digital caliper~     to measure changes in sitting knee length from over a 12-week study period amidst children~     in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who~     are receiving nutritional supplementation with micronutrients or without micronutrients.~   "
65408|NCT02201212|"~     In this research study, the investigators are evaluating the clinical benefit of everolimus~     in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations.~      This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug called everolimus to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is being studied. It also means that~     the FDA (the U.S. Food and Drug Administration) has not yet approved everolimus for your~     type of cancer.~      Everolimus is a drug that may stop cancer cells from growing by blocking an important factor~     (mTOR) involved in the growth of cells. This drug has been used in treatment for other~     cancers and is approved by the Food and Drug Administration for treatment of several types~     of cancer, including renal cell carcinoma. Treatment with this drug has been associated with~     responses in some patients whose cancers had mutations in TSC1 or TSC2. The investigators~     think that patients whose tumors have mutations in TSC1 or TSC2 may have a good chance of~     responding to treatment with drugs like everolimus.~   "
65409|NCT02201199|"~     Primary Objective:~      To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine~     given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic~     clamp setting in subjects with type 1 diabetes.~      Secondary Objectives:~      To compare the metabolic activity characteristics of single doses of insulin glargine given~     as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting~     in subjects with type 1 diabetes.~      To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in~     subjects with type 1 diabetes.~   "
65410|NCT02201186|"~     Patients with a bowel condition called ulcerative colitis have bowel surgery in which a~     portion of their bowel is removed and the reconnected at the small bowel to the anus.~     Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a~     condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics;~     however, some patients do not respond and need additional surgery. In this study, we will~     test an alternative treatment for this complication by performing manuka honey enemas twice~     a day for 30 days. This is a pilot study and ten patients will undergo enema treatment.~   "
65411|NCT02201173|"~     People with spinal cord injury (SCI) suffer from secondary health conditions that can result~     in undue physical challenges and impact participation in activities in everyday life.~     Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking~     function in both the animal and humans by reactivating spinal circuits through intensive~     therapy of muscles below the level of the injury. However, it is not known if LT also has~     beneficial health effects and it is the focus of this study proposed to be undertaken at~     Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal~     networks to help recover balance and walking after SCI and may correspond with improvements~     in health measures such as bladder function, breathing capacity, cholesterol and other~     cardiac risk factors markers, and the ability to stand upright without drops in blood~     pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body~     weight supported in a harness, while walking overground and with the practice of key~     exercises in the home and community. The emphasis is on loading the body through the legs~     without braces and other devices except where necessary to function at home. The overall~     objective of this study to capture and analyze health outcome data collected on 80 patients~     enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is~     funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people~     with SCI. The purpose of this application is to leverage the NRN funding, that provides~     support for LT and standardized outcome measures, to generate further knowledge on health~     outcomes after LT for individuals with SCI. The proposed project will be accomplished~     through the utilization of staff at each of the 6 NRN sites, lead by the study principal~     investigator and the lead clinical research coordinator at SBU. They will ensure the data~     are captured before and after LT in a standardized manner, at the correct time and entered~     into a de-identified database. The study hypotheses are that after LT, compared to before,~     patients with SCI will improve lipid profiles and insulin factors as measured by fasting~     blood tests; respiratory function as measured by specialized but easy to use breathing~     equipment; and blood pressure and heart rate during a maneuver to test for responses to~     abrupt changes in posture. The relevance of this proposal is that it will help to determine~     if there is an association between an intensive activity- based intervention (LT) and~     improvements in health and will be used to form the basis for a larger randomized clinical~     trial and clinical practice guidelines.~   "
65412|NCT02201160|"~     Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total~     liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the~     mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and~     finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular~     carcinoma. It is a common condition associated with a combination of disorders, namely~     obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS)~     was mainly studied in the adult population and very little in the paediatric population,~     while 15 and 25% of obese children are affectés. The severity of histological disease~     appears to be associated with the degree of obesity in children and particularly in the~     MetS. in addition, epidemiological data indicate that the incidence of this disease is~     increasing in children and positioning as the first NASH liver disease in North America. the~     revelation of the factors associated with the occurrence of NASH is a first necessary step~     to understanding this disorder worrying for the future of children and adolescents. In~     addition, clarification of the mechanisms responsible for its development is essential if~     the investigators want to consider targeted and effective treatments to slow the rat race of~     NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS.~     Finally, in view of growth and puberty of children, it would be extremely beneficial to find~     nutritional avenues that would avoid the side effects of chemical agents.~   "
65413|NCT02201147|"~     The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy~     using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.~   "
65414|NCT02201134|"~     Studying the feasibility of an initial sedation with inhalated sevoflurane during~     therapeutic hypothermia of cardiac arrests resuscitated patients.~   "
65415|NCT02201121|"~     Although induced hypertension decreased SVV and PPV,the influences of stroke volume~     variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were~     unknown.~   "
65416|NCT02201108|"~     Primary Objective:~      To assess the effect of teriflunomide in comparison to placebo on disease activity measured~     by time to first clinical relapse after randomization in children and adolescents 10 to 17~     years of age with relapsing forms of multiple sclerosis.~      Secondary Objectives:~        -  To assess the effect of teriflunomide in comparison to placebo on disease~          activity/progression measured by brain MRI and on cognitive function.~        -  To evaluate the safety and tolerability of teriflunomide in comparison to placebo.~        -  To evaluate the pharmacokinetics (PK) of teriflunomide.~   "
65417|NCT02201095|"~     During anaesthesia for caesarean section it is common to lose heat and become hypothermic,~     (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid~     and insulated from cold surfaces. There are also 2 types of machine available to actively~     warm women;~        1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air~          pockets that have warm air blown into them continuously by a fan.~        2. Conduction Warming Mattress - a thin mattress which covers the operating table and the~          woman lies on top. The padded mattress has strips of material that heat up when~          electricity passes through it, similar to a normal electric blanket.~      We plan to carry out a randomised controlled trial to compare these 2 methods with the~     current practice of no active warming.~      The hypothesis for this study is that active warming women during elective caesarean section~     prevents women's temperature from dropping and keeps them more comfortable than if active~     warming were not used.~   "
65418|NCT02201082|"~     The purpose of this study is to determine the optimal time for the nebulization depending on~     the respiratory physiotherapy session in cystic fibrosis patients.~   "
65421|NCT02201043|"~     1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the~          treatment of active ankylosing spondylitis.~        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the~          treatment of active ankylosing spondylitis, as well as selecting the appropriate dose~          for the further larger scale clinical trials.~   "
65422|NCT02201030|"~     This study will assess the immunogenicity and safety of primary vaccination with NBP606~     compared to the existing commercial vaccine, when given concomitantly with routine pediatric~     vaccinations.~   "
65423|NCT02201017|"~     A total of 621 consecutive male and female subjects, without established CAD, referred to~     exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina~     with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes~     mellitus who are referred EST for risk assessment prior to initiation of an exercise~     program.~      To validate the diagnostic performance of the HeartTrends device for the detection and~     ruling out of myocardial ischemia in a population of subjects who are currently referred for~     cardiovascular evaluation using EST.~      Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV~     analysis by the HeartTrends device for the detection of myocardial ischemia, as determined~     by stress echocardiography.~   "
65424|NCT02201004|"~     Primary Objectives:~      To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an~     add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over~     a period of 16 weeks in patients with type 2 diabetes mellitus.~      To assess the safety of tofogliflozin in combination with insulin treatment throughout 52~     weeks.~      Secondary Objectives:~      To assess the effects of tofogliflozin in comparison to placebo on:~        -  Body weight~        -  Fasting plasma glucose (FPG)~        -  Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of~          tofogliflozin.~   "
65425|NCT02200991|"~     Primary Objective:~      To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a~     standardized breakfast from baseline to Day 29.~      Secondary Objectives:~      To demonstrate:~        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,~          C-peptide and glucagon levels after a standardized breakfast~        -  Delaying gastric emptying (13C-acetic acid breath test)~        -  Safety and tolerability~   "
65426|NCT02200978|"~     Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of~     all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy~     (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths.~     Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there~     remains a subset of the patients in whom the disease relapses. Recently, a randomized~     prospective study showed that the addition of ATO to ATRA + chemotherapy treatment~     protocol had a significantly higher EFS in patients with APL than those treated with ATRA +~     chemotherapy protocol. The patients treated with ATO + ATRA + chemotherapy had a five~     years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a~     traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and~     tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL~     model in vivo and in the induction of APL cell differentiation in vitro . It is about 20~     years since RIF was used to treat ALP in China. Clinical studies showed that this agent was~     effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken~     orally, resulting in reducing the number of hospital days and the treatment cost. However,~     there is no report comparing treatment outcomes of ATO + ATRA + chemotherapy and RIF +~     ATRA + chemotherapy protocols in children with APL so far. For this purpose, therefore,~     investigators are going to conduct a multicenter and randomized prospective study in~     children with APL.~   "
65427|NCT02200965|"~     Health professionals usually lead in the management of long term conditions such as~     Diabetes. In a conventional professionally driven compliance model of care, patients may be~     placed in a secondary role. National audits show components of systematic diabetes care~     consistently fail despite several years of heavy expenditure in the service focused Diabetes~     Quality and Outcome Framework. To what extent is this due to the nature of that process~     which may not engage patients nor be focused on informed patient centred concerns? The aim~     of this research is to determine the effectiveness of a healthcare delivery approach in~     which patients, empowered with structured guidance and specific information about their~     diabetes, take decisions to get involved in their diabetes care as determined in hard~     measures of engagement and outcomes. The methodology will be by a whole population cluster~     randomised controlled study of an intervention the delivery of an individualised diabetes~     specific structured report, and we will look at its impact on measured key diabetes access~     and process outcomes. The contention is that the patients, guided in their understanding of~     empowerment and enablement, equipped with highly person specific risk stratified outcome~     based information, and informed regarding which actions they may accordingly take, will be~     enabled to make a significant and impactful contribution in improvement in their own care .~     This large scale project can deliver on that research question in a tested , efficient and~     cost effective manner.~   "
65428|NCT02200952|"~     The purpose of this study is to prove that luteal phase supplementation with recombinant LH~     can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk~     of OHSS~   "
65429|NCT02200939|"~     The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after~     implantation of the Rotation Medical Bioinductive Implant used as either a standalone device~     or adjunct to surgical repair in the treatment of supraspinatus tendon tears.~   "
65440|NCT02200796|"~     Objectives: To determine the effect of protein content of familiar breakfast meals on~     subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in~     normal weight (NW) and overweight (OW)/obese (OB) children.~      Specific Objectives:~      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying~     in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food~     intake at a test meal 4 h later in NW and. OW/OB children.~      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in~     protein (optimal protein from Objective 1a) or low in protein on TEF and substrate~     utilization over 5 h in NW and OW/OB children.~   "
65570|NCT02199080|"~     The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of~     intraatrial thrombus before performing an ablation of atrial fibrillation~   "
65430|NCT02200926|"~     The previous studies used the slow loaded breathing device for breathing training (Jones et~     al., 2010). It has been shown that slow loaded breathing training can reduce resting blood~     pressure and heart rate in essential hypertensive patients. However, this has not been~     studied in elderly with essential isolated systolic hypertensive patients. Not only highest~     prevalence of hypertension in Thailand was found in elderly but also physiological changes~     in the elderly are cause of interest in this special population. It has many advantages to~     use a slow loaded breathing training in elderly people. Firstly, it is low technology and~     easily implemented at home. Secondly, it can be practiced almost anytime and anywhere.~     Thirdly, the orthopedic complications of slow loaded breathing training are minimal.~     Finally, slow loaded breathing training may be enhancing cardiopulmonary function and other~     fitness traits, but it out of scope of this study. Moreover, slow loaded breathing exercise~     by itself should not result in any metabolic adaptation of skeletal muscles, such as the~     forearm, which had not been trained. If slow loaded breathing training modified some central~     component of the pressor reflex pathway in a way that single muscle training might work, as~     suggested above, then loaded breathing training would have a modulating effect on the~     pressor responses of muscles that had not been trained.~      We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax~     on blood pressure at rest and exercise in elderly with essential isolated systolic~     hypertension and also investigate the autonomic function and others that may be involved~     with the changed blood pressure in elderly with essential isolated systolic hypertension. We~     hypothesized that slow loaded and unloaded breathing training could reduce resting and~     exercising blood pressure in elderly with essential isolated systolic hypertension.~   "
65431|NCT02200913|"~     Recent studies indicate that patients with chronic low back pain (LBP) present problems in~     balance. Alterations in proprioception are the possible causes of alteration of postural~     balance in LBP.~      Previous studies reported an improvement of CSE on joint mobility, pain, functional~     disability, and trunk muscle activation pattern in patients with clinical lumbar instability~     (CLI); however, it was an immediate effect. However, previous studies did not report~     indirect effect may occur in CLI as postural balance and other kinds of exercise as~     strengthening in CLI. The general trunk strengthening exercise is common used in physical~     therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity.~     To our knowledge, the usefulness of CSE has not yet been investigated in CLI patients with~     outcome measure of balance.~      The present study will conduct to fill the gaps of previous studies which will provide~     immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity~     and ratio activation of trunk muscles and included blinding process of the assessor.~   "
65432|NCT02200900|"~     The most commonly used noninvasive respiratory support in preterm babies is Continuous~     Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are~     breathing by themselves). Increasingly High flow Nasal Cannula (HFNC, newer form of extra~     breathing support) therapy has found its way in clinical practice despite lack of good~     physiological data. There are also concerns about its potential to generate higher pressures~     in airways which can cause over distension of lungs.~      We would like to find out the effects of HFNC on~        -  1. Airway pressures in various flow rates and in comparison to CPAP.~        -  2. Breathing markers including respiratory rate (speed of breathing), oxygen and carbon~          dioxide levels, tidal volumes (how much air breathed in with each breath) and airway~          wash out (wash out of waste gas from the airway).~      We plan to study 15 babies each in three different weight categories supported with either~     CPAP or HFNC. The airway pressures, oxygen and carbon dioxide concentration in airway are~     measured by a small plastic catheter (similar to feeding tube but much shorter in length),~     carbon dioxide levels by skin sensors, how fast and how much babies breathe by a special~     vest applied like a layer of clothing. These will be recorded both on HFNC and CPAP. There~     are no blood tests or invasive procedures involved. The baby will be monitored throughout~     the study period of approximately two hours by experienced registrar who is trained to use~     the study device.~      This study will improve our understanding of physiological effects of HFNC and lead to~     better care of preterm babies.~   "
65433|NCT02200887|"~     Parkinson's disease is characterized in the advanced phases by an altered response to~     dompaminergic therapy for the occurrence of abnormal movements called dyskinesias, that~     worsens the quality of life of the patient and exposes him to comorbidities. Several data~     show a reduction in the amount of slow wave sleep that corrrelates inversely with disease~     duration. Since this stage of sleep is linked to mechanisms of deletion of superfluou~     information we hypothesize that the onset of dyskinesias is related to such alteration of~     sleep.~      -With this study we want to investigate, by means of high-density electroencephalography~     (hd-EEG), the sleep and in particular the slow wave in order to clarify the relations with~     the development of dyskinesias.~   "
65434|NCT02200874|"~     The purpose of this study is to investigate the effectiveness and efficiency of a structural~     clinical nutrition support by an interdisciplinary Nutrition Support Team. To do this we~     examine nutritional management and its economic impact as well as the nutritional status of~     patients of University Hospital Tübingen before and after the implementation of a~     Nutritional Support Team.~   "
65435|NCT02200861|"~     In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts~     were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep~     sedation. All patients dates will evaluate from their patient file retrospectively from 2011~     to 2014.~   "
65436|NCT02200848|"~     This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this~     study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at~     different dose levels, in combination with the drug rituximab. We want to find out what~     effects, good and/or bad, they have on patients with CLL/SLL.~      The hypothesis of the study is that it will be safe to give the three drugs in combination~     and the information learned from this trial will be used to study the 3 drug combination is~     a larger future trial.~   "
65437|NCT02200835|"~     Few data exist on gender-related differences in clinical features, management, and outcomes~     of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD~     from 15 hospitals in China to access differences in clinical features, management and~     outcomes between men and women. in this study, our results provided new insights into~     gender-related differences in clinical features, management and outcomes in the Chinese~     patients with AAD. Important implications may be helpful to improve diagnostic and~     therapeutic outcomes.~   "
65438|NCT02200822|"~     The primary objective of this study is to demonstrate that in patients with~     recuperated/normalized left ventricular function, defined as an ejection fraction (EF) ≥~     50%, after implantation of cardiac resynchronization therapy, device treatment is sufficient~     and neurohumoral blocker therapy can safely be withdrawn~   "
65439|NCT02200809|"~     Purpose of the investigators study is to determine the short and medium term histological~     cancer control of focal therapy using MR-guided focal laser ablation therapy in the~     treatment of localised prostate cancer.~   "
65441|NCT02200783|"~     Excessive radiation received by the operator has been described as a possible drawback of~     the radial catheterization technique when compared with the femoral access.~      The study hypothesis is that the use of radial access device dedicated radioprotective~     TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral~     technique and superior to standard radial technique as radioprotection strategy to the~     operator in patients with acute coronary syndromes acute and submitted to cardiac~     catheterization.~   "
65442|NCT02200770|"~     To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD~     attack in subjects with NMO/NMOSD.~   "
65443|NCT02200757|"~     The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared~     to topotecan in subjects with metastatic small cell lung cancer.~   "
65444|NCT02200744|"~     The purpose of this study is to determine the incidence of recall in patients managed in~     emergency department with a procedural sedation protocol using propofol in a population of~     250 .~   "
65445|NCT02200731|"~     To investigate whether a home-based psychosocial family intervention that takes place~     shortly after ending the primary medical treatment can help families adjust to their~     cancer-related psychological issues.~   "
65446|NCT02200718|"~     A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple~     Sclerosis to demonstrate safety & efficacy~   "
65447|NCT02200705|"~     To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and~     distant recurrence of early stage breast cancer .~   "
65448|NCT02200692|"~     Allergic transfusion reactions are a common complication of transfusion by blood components~     containing plasma. This study aims to investigate passive transfer of Immunoglobin E~     antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent~     Detergent plasma.~   "
65449|NCT02200679|"~     The aims of the national population-based study on Autism Spectrum Disorder (ASD) include:~     (1) to understand the overall prevalence of ASD in children aged 6-12 years in 8 cities~     (n=120,000), (2) to explore environmental and genetic risk factors associated with ASD~   "
65450|NCT02200666|"~     The purpose of the investigation is to confirm the following under the post-marketing actual~     use of Forxiga Tablets (hereinafter referred to as Forxiga).~        -  Development of ADRs specified as Key Investigation Items and the risk factors~        -  Contributing factors possibly having an impact on the safety and efficacy~        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug~          use~   "
65451|NCT02200653|"~     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and~     COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during~     the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives~     include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during~     the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from~     baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes~     from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer,~     and 4) responder rates based on both ABPM and trough cuff blood pressure~   "
65452|NCT02200640|"~     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan 40-80 mg)~     and COZAAR® (losartan 50-100 mg) in lowering ambulatory diastolic blood pressure (DBP)~     during the last 6 hours of the 24-hour dosing interval as measured by ABPM after 8-weeks~     treatment. Secondary objectives include evaluations of: 1) change from baseline in mean~     systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as~     measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the~     24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured~     by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff~     blood pressure~   "
65453|NCT02200627|"~     The purpose of the investigation is to confirm the following under the post-marketing actual~     use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients.~        -  Development of ADRs specified as Key Investigation Items and the risk factors~        -  Contributing factors possibly having an impact on the safety and efficacy~        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug~          use~   "
65454|NCT02200614|"~     The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in~     patients with non-metastatic castration-resistant prostate cancer.~   "
65455|NCT02200601|"~     The study sponsor has developed a patented medical device called Seipher Wellness. This is a~     non-invasive medical device that assesses heart health based on established cardiac~     parameters; timing events of the cardiac cycle. These are specific parameters captured and~     analyzed by the device. A ratio of two specific timing parameters provides an assessment of~     the subject's overall heart health. The aim of this study is to validate the device~     algorithm across a range of subjects.~   "
65456|NCT02200588|"~     Schizophrenia is a chronic brain disease that is still understood as a condition that limits~     the development of a normal life for the patient who suffers it and their families. The idea~     that only one third of patients have a good outcome is still in force, despite the lack of~     clinical and epidemiological longitudinal studies that have addressed this issue rigorously.~     Most studies that have established the poor prognosis of the disease have followed a~     cross-sectional design and are based on samples of patients undergoing treatment in~     healthcare devices and therefore represents an important bias. Based on clinical, cognitive,~     functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can~     establish that the particular idea of poor prognosis should be reconsidered. The development~     of longitudinal studies of first-episode patients in representative samples of a population~     and long-term it is of high value to shed light on the clinical course of the disease. The~     belief that there are factors determining the disease progression beyond the initial three~     years brings us to publish this study.~      Given this background, our project's main objective is to know the evolution at 10 years of~     patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is~     that a higher percentage of expected patients have a favorable outcome of the disease.~     Factors such as enhancing treatment completion, abstinence from drug use, return to work,~     the reduction of expressed emotion in families during the early years of the disease (at~     least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution~     of patients on long-term (10 years). Our hypothesis defends the existence of certain factors~     as independent risk factors for poor clinical and functional outcome of patients who should~     be known for establishing intervention strategies that attempt to mitigate their impact on~     the quality of life of patients and their families.~   "
65491|NCT02200120|"~     The purpose of this study is to examine the placement, timing, associated complications,~     efficacy of temporary and tunneled catheters for renal replacement therapy in patient with~     acute kidney injury.~   "
65457|NCT02200575|"~     Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal~     conditions of use after market launch and to supplement the present data on the safety of~     telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to~     control blood pressure for 24 hours, especially during the last few hours of the dosage~     interval. Additionally to evaluate compliance with treatment, as an indirect measurement,~     and to confirm the efficacy and possible risks associated with treatment.~   "
65458|NCT02200562|"~     Phase I/II study of ipilimumab concurrent ipilimumab and dabrafenib as first line treatment~     in Stage III or IV melanoma.~      Assessing safety of Ipilimumab and dabrafenib in combination. Also, assessing disease~     control rates.~   "
65459|NCT02200549|"~     Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the~     world, represents an important public health challenge. It is also a major cause of chronic~     morbidity, mortality and disability throughout the world, leading to a heavy social and~     economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,~     pulmonary rehabilitation is recognized as a core component of the management of individuals~     with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,~     increase exercise capacity, and improve quality of life.~      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one~     of the best available means of improving muscle function in COPD.The most commonly form is~     cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an~     additional benefit on inspiratory muscle strength, endurance and exercise capacity in~     patient with COPD.~      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle~     training and cycle training. This study will evaluate the effects of combined inspiratory~     muscle training and cycle training in patients with COPD.~   "
65460|NCT02200536|"~     Governmental initiatives (such as Sure Start in the UK) have integrated an oral health~     promotion intervention within their maternal and child health program and delivered dental~     education and enabling resources (a gift bag including a baby toothbrush, fluoride~     toothpaste and a trainer cup) to infant's mothers. Whilst this approach has minimal~     financial implications of human resources, no evidence exists regarding its effectiveness in~     establishing desirable infant's oral health behaviours. In Syria, there is a great need for~     developing an infant's oral health promotion program to promote oral hygiene practice,~     provide access to fluoride and terminate bottle-feeding practice. Thus, the current study~     aimed to test the effectiveness of an integrated infant's oral health promotion intervention~     within the Syrian national immunization program, which delivered printed dental education~     materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in~     establishing one-year old infant's oral hygiene and bottle-feeing termination practices.~   "
65461|NCT02200523|"~     The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by~     combining multiple steps that burden conventional EEG procedures into one. The investigators~     believe that the proposed system will reduce patient hookup time by more than 50% (from 40~     to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required~     for the EEG recording will make EEG more feasible in time critical situations and will~     improve patient care and service. The clinical testing in Phase II will investigate patient~     acceptance, clinician acceptance, time savings, and signal quality for 3 different~     environments: the large hospital institution, a small rural hospital setting and in an~     emergency department.~   "
65462|NCT02200510|"~     The purpose of the study is to develop patient-provider clinical support tools to improve~     clinical practice, patient self-management, and disease outcomes in sickle cell disease~     during transition to adult care. The investigators hypothesize that these clinical support~     tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,~     user friendly, and beneficial. The investigators hypothesize that participants will~     demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain~     these gains during the follow-up period (up to 1 year post-intervention).~   "
65463|NCT02200484|"~     Specific Aims:~        1. The primary aims of this study are to conduct formative interviews with teen mothers to~          inform a targeted adaptation of empirically based weight management and parent training~          programs for teen mothers for their preschoolers.~        2. To conduct a small pilot and post-pilot focus group of the feasibility and~          acceptability of recruitment and retention methods & the intervention.~      Study Hypotheses:~      Given the small sample size and fact that this is a pilot study, focus will be on estimating~     effect sizes rather than statistical hypothesis testing. However, the investigators~     exploratory hypotheses are as follows:~        1. (a) The adapted intervention will be more feasible compared to the wellness control~          condition, with a participant retention rate of ≥80% and an average adherence~          (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥~          75%; (b) The adapted intervention will be more acceptable compared to the wellness~          control condition, based on the Consumer Satisfaction Scale and Therapy Assessment~          Inventory with ≥90% of the participants responding to the item, In general how~          satisfied were you with the intervention? by choosing unsatisfied to very~          satisfied.~        2. (a) The adapted intervention will result in greater improvements in child behavior and~          parent-child connectedness compared to the control condition; (b) the adapted~          intervention versus wellness control condition will result in greater increases in~          child and teen mother individual as well as joint physical activity and physically~          active play and greater reductions in individual and joint teen mother and child~          sedentary behavior (television viewing) from baseline to post-intervention; (c) the~          greater teen mother and child fruit and vegetable consumption; and reduced child juice~          and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the~          adapted intervention versus wellness control condition will result in smaller increases~          in child BMI percentile and teen mother BMI from baseline to post-intervention; (e)~          participants who attend higher numbers of intervention sessions will show greater~          improvements in target outcomes (child behavior, parent-child connectedness, and teen~          mother and child physical activity, sedentary behavior and BMI); with participants~          receiving the adapted intervention versus wellness control showing the greatest~          dose-based improvements.~   "
65464|NCT02200471|"~     This study aims to understand the impact of VeinViewer technology during routine cosmetic~     and dermatologic procedures.~   "
65465|NCT02200458|"~     This study will look at the performance capabilities of software for VeinViewer.~   "
65466|NCT02200445|"~     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of~     Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.~   "
65467|NCT02200432|"~     The purpose of this study is to maximize patient perspective and effectively support~     lifestyle choices, investigators will develop the Patient Experience Recommender System for~     Persuasive Communication Tailoring. PERSPeCT is a computer system that will assess adult~     smokers' perspective, to understand the patient's preferences for smoking cessation health~     messages, and provide personalized, persuasive health communication that is useful to the~     individual patient in making positive health behavior changes such as smoking cessation.~   "
65492|NCT02200107|"~     The purpose of this study is to determine the ability to assimilate and implement an~     integrated treatment program osteoarthritis of the knee, including the diagnosis and~     follow-up by a family physician in primary care clinics, combined with patient self-care~     training and physiotherapy program~   "
65468|NCT02200419|"~     This multi-centre study will provide sound, generalizable data on the effectiveness of a~     POC-based algorithm to determine to what extent this guideline can reduce blood product~     transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at~     10 participating hospitals. The proposed trial addresses several important research and~     clinical issues and has the potential to markedly improve the transfusion management and~     surgical care in general of cardiac surgery patients.~      The intervention will be a novel POC-based algorithm that has been shown in a pilot study by~     us to be associated with a substantial reduction in blood product transfusions. The~     algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of~     blood loss. The primary outcome will be avoidance of red blood cell transfusion during~     hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate.~     Secondary outcomes will include avoidance of red blood cell use and other blood products~     (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse~     clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data~     will also be collected for future health-economics analyses.~      Largely due to the limitations of existing evidence, however, such algorithms are rarely~     used in clinical practice. The proposed trial will provide sound, generalizable data on the~     effectiveness of a POC-based algorithm to guide their future use. An integrated blood~     management algorithm that employs POC coagulation tests will reduce blood product~     transfusions in cardiac surgery, thereby improving clinical outcomes.~      Does an integrated blood transfusion algorithm that employs POC coagulation tests applied~     across a network of hospitals reduce blood transfusions and associated adverse outcomes in~     cardiac surgery?~   "
65469|NCT02200406|"~     Background: Although substitution therapy has been shown to be highly effective to retain~     opioid-dependent patients in treatment and reduce drug use, this population is afflicted by~     numerous conditions including depression. Unfortunately, studies published thus far have~     reported inconsistent or no difference in response between placebo therapy and~     antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the~     feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and~     explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of~     DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms~     at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will~     lay down the foundation on which a larger multisite clinical trial could be conducted to~     examine DESV as new treatment for opioid-dependent population with comorbid depression.~   "
65470|NCT02200393|"~     Compromised respiratory function as a result of tetraplegia leads to many tetraplegics~     requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is~     associated with additional costs to the local health care provider and reduced quality of~     life of the patient. Electrical stimulation of the abdominal muscles has previously been~     used to improve the respiratory function of tetraplegic patients in the chronic stage of~     injury. In this study the investigators aim to evaluate whether electrical stimulation of~     the abdominal muscles can assist the process of weaning from mechanical ventilation in acute~     ventilator dependent spinal cord injured patients.~   "
65471|NCT02200380|"~     This is an open-label, multicenter, prospective pilot study of CDX-301 with or without~     plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come~     from another person). HLA-matched sibling healthy volunteers (donors) and patients with~     protocol specified hematologic malignancies (recipients) will be enrolled.~   "
65472|NCT02200367|"~     In the treatment of depression, primary care team play an important role, but they are most~     effective when inserted into a collaborative model of disease management.~      Hypotheses:Depressed patients treated in rural primary care clinics participating in a~     e-mental heath collaborative programme to manage depression achieve at least 20% better~     recovery rates in comparison with the control group three months after the baseline~     assessment.~      Goal: to compare the effectiveness of a e-mental health collaborative programme with usual~     care in rural primary-care clinics.~      Methodology: a clinical trial with two arms will be conducted in 13 community rural~     hospitals in Chile. The active group will participate in a collaborative programme between~     primary care teams and specialized teams, with support from an electronic platform and a~     call center.The control group will receive usual care, according to the Ministry of Health's~     Guidelines to Depression.To evaluate inclusion criteria -depressive patients aged between 18~     and 70 years- and exclusion criteria -current in treatment for depression- an interview will~     be used that will include the Mini-International Neuropsychiatric Interview (MINI) to~     evaluate depression .The principal outcome will be depressive symptoms measured with the~     Beck Depression Inventory (BDI-I), and secondary outcome quality of life measured with the~     Health Survey (SF-36) at three and six months after baseline assessment.To detect a~     difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, would require~     152 depressed persons (76 to intervention and 76 to control group).A design effect of 1.35~     based on an Intraclass Coefficient Correlation (ICC) of 0,03839 and 13 clinics were~     considered. After applying the design effect the sample needed increased to 206 depressed~     persons. Considering a retention rate of approximately 85% 237 depressed cases will be~     needed.~      A program of this kind may be useful to assist primary care teams in remote areas of the~     country, in order to improve treatment outcomes for depression that is currently addressed~     at the primary care level.~   "
65473|NCT02200354|"~     For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and~     cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the~     PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not~     progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted~     from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab~     continuous maintenance might be better treatment option, considering the results from~     AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients.~     Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with~     bevacizumab,we conducted this study.~   "
65474|NCT02200341|"~     The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive~     Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in~     individuals suffering from major depressive disorder (MDD).~   "
65475|NCT02200328|"~     The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing~     the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk~     for this infection.~   "
65476|NCT02200315|"~     The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial~     prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.~   "
65477|NCT02200302|"~     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the~     vertebrae and discs gradually develop a curvature that is first detected in patients between~     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from~     radiographs by the Cobb angle .~      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each~     vertebra and disc between the superior and inferior end vertebrae . Although a small curve~     is well tolerated and does not require treatment, a large curve can progress to the point~     that it is cosmetically unacceptable, interferes with chest wall mechanics, and produces~     cardiac and pulmonary compromises. The natural history of AIS apparently includes 2 stages:~     the initiation of the curve and its subsequent progression. The factors responsible for the~     initiation of the curve are unknown, but the subsequent progression of the curve is clearly~     associated with the adolescent growth spurt . The primary risk factors for progression~     include age at onset and the magnitude of the curve; young patients with large curves are at~     the highest risk .~      Although numerous treatment methods have been recommended for patients with AIS, the only~     accepted treatment includes bracing for skeletally immature patients with curves between 25~     and 40 degrees and operative correction with spinal fusion for patients with curves greater~     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with~     bracing has caused compliance problems with wearing the brace and many patients only wear~     the brace at home . While operative intervention completely corrects the scoliosis or rib~     hump, it eliminates segmental spinal motion, and concentrates stresses at the ends of the~     fusion potentially leading to disc degeneration and back pain.~      Despite satisfactory short-term results of operative instrumentation and fusion, a less~     invasive technique preserving more motion with a smaller scar represents a major~     improvement. Realizing this goal is contingent on treating curves early, before they~     progress to an irreversible deformity, and when there is still enough residual growth and~     remodeling potential.~      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C~     system is designed to correct the deformity step by step along a period of time, giving the~     skeletal and soft tissues time to accommodate any incremental correction.~      The MID-C System inherent benefits are:~        -  Only two screws are used~        -  Incision size is much smaller~        -  Simpler operation with shorter operative time~        -  Less complications (attributed to the three points above).~        -  Minimal spinal mobility loss.~      All the device components are made of materials well accepted in the orthopedic field and~     are fully biocompatible (see Investigator Brochure).~      The unique concept of the system and the materials used may provide favorable results as~     follows: Smaller scare, quicker healing period and better spine mobility over the years.~      This study is designed to demonstrate that the MID-C System is safe and effective.~   "
65493|NCT02200094|"~     This study is designed to supplement, under conditions of usual clinical practice, the data~     on the efficacy and safety of Micardis® collected during the clinical studies.~   "
65494|NCT02200081|"~     Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC)~     as maintenance treatment in patients with extensive disease small cell lung cancer (SCLC)~     who achieved at least a partial response (PR) following platinum-based first-line therapy.~   "
65554|NCT02199288|"~     This prospective, open-label, multicenter, observational study will investigate the~     effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in~     patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV~     (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8~     months.~   "
65478|NCT02200289|"~     Household air pollution from cook stoves using solid fuels dominates total population air~     pollution exposures. Females and young children are disproportionately affected as they~     either perform or are present for the majority of cooking activities. Worldwide, household~     air pollution is responsible for 1.6 million premature deaths annually, largely secondary to~     respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children~     that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases~     worldwide are secondary to household air pollution. Reducing female and infant morbidity and~     mortality related to household air pollution secondary to biomass smoke exposure is a~     top-priority public health goal.~      We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance,~     which negatively impacts lung development. We will leverage the success of the Ghana~     Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of~     1,415 mother-infant pairs, to examine the impact of maternal household air pollution~     exposure on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at~     least 150 infants, analyze cord blood samples for markers of oxidant imbalance and perform~     infant pulmonary function testing. Cord blood will also be prepared for future immune,~     hormonal and epigenetic testing. This study will allow us to consider interventions, such as~     maternal antioxidant dietary supplementation during pregnancy, to compliment existing cook~     stove interventions and reduce household air pollution-related morbidity and mortality.~   "
65479|NCT02200276|"~     The immune system is the part of the body that protects against infection. The immune system~     often doesn't work as effectively as people get older. This research is being done to find~     out how the immune systems in older people who are over age 75 respond to influenza vaccine~     (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common~     virus infection in older persons affects the immune response in people older than 75 years~     of age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of~     influenza (Flu) infections and is recommended every year for all persons 50 years and~     older. People who are older than 75 years of age are considered healthy or frail may join. A~     total of 525 persons will be participating in this study.~      In order to determine if you are qualified for the study, we would ask you to answer a few~     questions over the phone that will take approximately 5 minutes. If you qualify and agree to~     proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are~     unable to come to Bayview, one of our staff can visit you at your home. During that visit we~     obtain consent, review your medical history, and measure your vital signs, walking speed and~     grip strength. We will also administer a few brief questionnaires and collect urine and~     blood samples. We will then give you the Flu shot for free. Three to four weeks after you~     receive the Flu shot, you will have another visit at Johns Hopkins Bayview or your home~     where we will repeat some of the questionnaires, vital signs, and collect a second blood~     sample. Throughout the study, we will call you once a week to ask about your general health~     and any Flu-like symptoms. These calls will be made throughout the Flu season which~     typically lasts through the end of May. If you begin to have any influenza like symptoms at~     any time during the study, we ask that you call our office to report these symptoms so that~     we may perform a nasal swab to confirm influenza, and a third blood draw to look at the~     immune response and protection of influenza vaccine.~   "
65480|NCT02200263|"~     The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects~     of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or~     oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo~     (no treatment) gel pill over the period of 12 months, with study visits approximately every~     3 months for the first year and a final visit 18 months after enrollment.~   "
65481|NCT02200250|"~     Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for~     Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).~   "
65482|NCT02200237|"~     This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in~     health children and infants aged from 2 months to <12yrs.~   "
65483|NCT02200224|"~     The purpose of this study is to:~        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria~          Gonorrhoeae (NG) testing on antibiotic over and under treatment for CT/NG in women~          evaluated in the Emergency Department (ED) for a Sexually Transmitted Infection (STI).~        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic~          under and over treatment for TV in women evaluated in the ED for an STI~        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria~          Gonorrhoeae (NG) and TV testing in the Emergency Department setting.~      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually~     Transmitted Infection diagnosis.~   "
65484|NCT02200211|"~     The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game~     play 7 days per week with 2 hours/day patching 7 days per week in children 5 to <17~   "
65485|NCT02200198|"~     Malnutrition affects 50% of hospitalized patients around the world and causes changes in~     respiratory muscles predisposing the development of pulmonary complications probable,~     because of the ineffectiveness of cough. How the training of respiratory muscles can improve~     the effectiveness of cough, malnourished patients could benefit from this train however, the~     training of the muscles in malnourished patients has not been tested for safety or~     efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory~     muscle training to improve the potency of cough in malnourished patients.~   "
65486|NCT02200185|"~     The investigators test a different technique using morphine to improve pain relief in~     patient visiting the emergency department with acute trauma pain, for this we are comparing~     three different methods of morphine administration:~        -  intravenous titrated morphine~        -  low dose nebulized morphine and~        -  high dose nebulized morphine~   "
65487|NCT02200172|"~     The purpose of this feasibility study is to inform a larger randomized, placebo-controlled,~     double blind, parallel-group, single-centre trial of an oral, daily administered single dose~     of melatonin to prevent delirium in patients with advanced cancer.~   "
65488|NCT02200159|"~     Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU~   "
65489|NCT02200146|"~     The aim of the study is determining the non-inferiority in the overall success rate and the~     safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids~     compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary~     sarcoidosis.~   "
65490|NCT02200133|"~     This randomized study will compare a personalized Survivorship Care Plan (SCP) template with~     usual care (no SCP). The investigators hypothesize that the personalized SCP that~     incorporates patient specific treatment exposures and provides a framework for long term~     followup based on those exposures and subsequent risks for late complications will enhance~     patient survivorship confidence in knowledge, increase adherence to recommended healthcare,~     improve health behaviors and reduce HCT-related emotional distress.~   "
65495|NCT02200068|"~     Recommendations of Rheumatoid Arthritis management agree on the necessity of patient~     self-involvement in the care. In parallel, the observation of the adoption rate of websites~     directed toward patients may indicate that this involvement is shared by a large number ot~     the population.~      However, most of these sites are only informative and few of them offer patients to be~     engaged to generate their own data that can impact on the patient-physician relationship by~     easing the dialog and then leading to better mutual understanding.~      As new web or mobile services allowing patients to self-report their outcomes are~     flourishing only a very few of them have already addressed the their impact of the~     patient-physician relationship.~      The main objective of this study is to quantify the effect of a website (Sanoia) on the~     quality of patient-doctor interactions, as perceived by the patient using the french~     translations of the Peppi Questionnaire during the 12 months observation period.~      In France, the patient protection committee (CPP) has ranked this study in Soins Courants~     (Usual Care).~   "
65496|NCT02200055|"~     Being able to accurately monitor patient bodily fluid levels during and after surgery is~     very important, as there are a number of complications that can arise if a patient's fluid~     levels become unbalanced, such as swelling within or pressure on various bodily organ~     systems. There are several different ways that physicians can monitor a patient's fluid~     balance during and after surgery, such as measuring the amount of urine output or the use of~     central venous catheters which measure the pressure in the veins entering the heart. Most of~     these techniques are invasive since they require tubes to be inserted into the body. A~     potential alternative would be to use a noninvasive technique such as electrical~     bioimpedance (BIA).~      Bioimpedance assessments work by using small electrical currents that can accurately predict~     both the water surrounding the outside of cells in the body, as well as the total amount of~     water in the entire body. Electrical bioimpedance assessments have been used to estimate~     patient swelling following surgery (edema), to measure the volume of blood the heart is~     pumping out, as well as to calculate body fat percentages.~      The goal of this study is to relate this technology to fluid shifts within the body that~     occur as a result of surgery, in particular, major intra-abdominal surgeries. By using~     bioimpedance during and after surgery, the investigators will compare the data collected~     with that calculated by using traditional measures of body fluid status, such as urine~     output and intraoperative blood loss. During the study, the bioimpedance monitors will not~     replace the standard bodily fluid monitors and will not interfere with their readings.~     Additionally, the electrical current produced by the bioimpedance monitors is too small for~     patients to feel and will not interfere with medical devices such as pacemakers.~   "
65497|NCT02200042|"~     This randomized phase III trial studies how well gemcitabine hydrochloride and cisplatin~     with or without radiation therapy work in treating patients with localized liver cancer that~     cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving~     gemcitabine hydrochloride and cisplatin is more effective with or without radiation therapy~     in treating patients with localized liver cancer that cannot be removed by surgery.~   "
65498|NCT02200029|"~     A research study of an approved drug called Heptral®, ademetionine, to treat adults with~     intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum)~     in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with~     liver disease has shown that ademetionine is effective.~   "
65499|NCT02200016|"~     Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A~     randomized controlled double blinded MRI study comparing long versus short axis catheter~     placement. Which procedure for insertion of nerve catheters for postoperative pain after~     major foot and ankle surgery is the best~   "
65500|NCT02200003|"~     Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective,~     and easy to administer, targets a key mechanism in pathological anxiety - the threat bias,~     or exaggerated attention feared or threatening stimuli. It remains unclear how and for whom~     ABMT is effective, limiting clinical translation. The proposed research involves an RCT~     using a highly sensitive measure of neurocognitive functioning, scalp-recorded event-related~     potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety.~     Researchers will recruit 90 anxious participants to engage in the study and pursue the~     following three specific aims: Aim 1 will examine relations between neural and behavioral~     responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat,~     threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and~     reductions in threat bias and anxiety. Researchers will test whether post-training neural~     changes, specified in Aim 2, are associated with reductions in behavioral threat bias and~     anxiety severity. Researchers will also explore whether ERP measures of greater attention~     capture and/or reduced control of attention to threat at baseline predict treatment~     response, helping identify which patients will benefit most from ABMT. Through the~     innovative combination of a highly sensitive neurocognitive measure and an RCT design, this~     study aims to delineate core neurocognitive responses to threat as mechanisms in the~     remediation of anxiety. Confirmation of study hypotheses would, ultimately, accelerate the~     pace of development of more biologically-informed, accessible, and targeted interventions~     for anxiety.~   "
65501|NCT02199990|"~     Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool~     children propofol and etomidate on behavioral and cognitive function after intravenous~     anesthesia in according to beta protein in serum and plasma glutamate (Glutamic acid, Glu)~     and gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid~     development period children's cognitive function after anesthesia short-term and long-term~     change process and its possible mechanism is studied, for the current international debate~     on anesthetics effects on developing kids brain nerve research hot spot in the city of~     clinical basis and research argument, for pediatric anesthesia clinical safety, provide~     theoretical basis for the rational use of drugs.~   "
65512|NCT02199847|"~     The general aim of this study is to assess the effects of Pharmaton® Caplets on mental~     performance and physical fatigue in nurses and nursing auxiliaries working night shifts~   "
65513|NCT02199834|"~     In this project, the investigators hypothesize that in an integrated, multifaceted,~     team-based program incorporating comprehensive assessment with risk stratification, diabetic~     patients with high risk of negative emotions and hospitalization will benefit from~     additional peer support which will improve their psychological health, cardio-metabolic~     control, self-management, quality of life and reduce hospitalization. The investigators~     further hypothesize that peer support will interact with regular personalized feedback~     reporting to improve clinical outcomes.~   "
65555|NCT02199275|"~     During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a~     performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general~     anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.~   "
65502|NCT02199977|"~     There are compelling medical and public health reasons to reduce unnecessary consumption of~     antimalarials and strong evidence to support the use of RDTs in malaria case management. The~     primary study hypothesis to be tested is that clients who know they will receive a subsidy~     conditional on a positive test are more likely to opt for testing before deciding which drug~     to buy. The primary endpoint is whether subjects choose to be tested for malaria with a~     rapid diagnostic test. The secondary endpoint is whether they purchased an artemisinin~     combination therapy (ACT) or not. The primary outcome of interest is to compare the~     proportion of participants who choose to receive a free malaria diagnostic test when they~     can receive a subsidy for a discounted drug conditional on a positive test (Group A compared~     to Group B) compared to those without the offer of a conditional subsidy. The investigators~     will use an experimental design that randomly assigns clients to one of four groups. Field~     workers will canvas households in the study area looking for individuals who have fever or~     history of fever or illness in the last 24 hours (current illness) who have not yet taken~     drugs or sought treatment outside the home. Clients who meet the inclusion criteria and give~     verbal consent to participate will be randomly assigned to one of the four groups. They will~     be given the location and contact information for their local community health worker who~     can provide a malaria rapid diagnostic test if they choose to be tested. They will also~     complete a survey tool. One week later, the field worker will return to interview the~     participant and determine whether they were tested, what action they took for their illness,~     what medicine they purchased and how much they paid. The investigators will summarize~     clients' choice by the four randomized study groups.~   "
65503|NCT02199964|"~     This study will test that hypothesis that topical administration of the FDA approved~     immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface~     disease that results from a short term low humidity environmental stress~   "
65504|NCT02199951|"~     WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of~     uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the~     African market and will be used by the public health care system. The collection of safety~     data and risk evaluation through observational data are critical in order to assess~     risk/benefit profile of each ACT through its life cycle and providing information on the~     best use. Additionally there is need to assess the impact of the introduction of a new ACT~     in the evolution of its efficacy and malaria morbidity and mortality.~     Dihydroartemisinin/Piperaquine (DHA/PQP) is a new ACT approved by European Medical Agency~     and a number of African countries. This is a phase IV observational evaluation of the~     clinical safety of the fixed-dose DHA/PQP (Eurartesim®) in public health facilities within~     selected Health and Demographic Surveillance Centres in Burkina Faso (Nouna), Mozambique~     (Manhica), Ghana (Dodowa, Kintampo, Navrongo), Tanzania (Rufiji) and other African countries~     to be added. Eurartesim® will be used as first-line treatment of uncomplicated malaria an~     objective to evaluate the safety of Eurartesim® when used under usual conditions in 10,000~     patients. Patients > 6 months and 5 kg except pregnant women will be enrolled and~     Eurartesim® administered as a single daily dose regimen over 3 days. Patients will be~     contacted at Day 5 (± 2 days) after treatment, to assess recovery and any adverse events.~   "
65505|NCT02199938|"~     The aim of the study is to improve the understanding of molecular mechanisms in the~     development and progression of musculoskeletal tumors. These tumors do have in general~     unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or~     chemotherapy) could not enhance the prognosis of these patients during the last ten to~     fifteen years. Therefore the investigators chose a new way, as they try to identify markers~     on a genetic level, who ideally act as a basis to develop new treatment options.~   "
65506|NCT02199925|"~     If autism is the consequence of a chronic inflammatory process preventing the infant brain~     from forming the proper neural connections, then treatment that reduces inflammation might~     have a positive impact on autism. IGIV treatment has been known to suppress inflammation and~     has been used in the treatment of inflammatory conditions and autoimmune diseases.~   "
65507|NCT02199912|"~     Cachexia associated with cancer is a grave and most of the time irreversible common~     situation. It seems independent from the size of the tumor or from its metastatic character.~     The consequences for the management of the patient are major and exceed widely the frame of~     the nutrition.~      Undernutrition of patients with cancer is described by a decrease of the energy~     contributions and a loss of muscular and fat mass, leading to a progressive functional~     deficiency which can go to the cachectic state.~      Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia~     but it remain too indistinct to allow an early and efficient screening and set up effective~     measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast~     iron of the energy reserves.~      It is necessary to have clinical and biological markers with diagnostic aim and forecasts~     during the situations precedents the appearance of cachexia.~      The present study will allow calibrating a longitudinal study, which could confirm the value~     of measures made for the diagnosis of pre-cachexia.~   "
65508|NCT02199899|"~     The objective of the present study is to obtain information about the safety and~     tolerability of BIIF 1149 BS, to determine the pharmacologically active dose (range) by~     performing a citric acid challenge test and to obtain preliminary pharmacokinetic data~   "
65509|NCT02199886|"~     Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics~     associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in~     tumour to that of normal tissue in patients with non-small cell lung cancer and to measure~     human anti-human antibody (HAHA) concentrations.~   "
65510|NCT02199873|"~     The objective of the present study is to obtain information about the safety and~     tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by~     performing a methacholine challenge test and to obtain preliminary pharmacokinetic data~   "
65511|NCT02199860|"~     The purpose of the present study was to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses~     of spray-dried powder in healthy male and female volunteers. According to the original~     protocol, the primary objective was to investigate the safety and tolerability of single~     doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following~     implementation of Amendment 2, this objective was extended to the second spray-dried~     inhalation formulation SD II with and without concomitant administration of lactose~   "
65514|NCT02199821|"~     Background and Aims: Nutritional support is considered an integral part of the supportive~     care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with~     omega-3 fatty acids can modify the inflammatory response. The aim of this study is to~     compare plasma cytokines levels in children after bone marrow transplantation using a lipid~     formula enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.~      Methods: A randomized double blinded controlled study including 14 children with BMT and~     requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or~     soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to~     analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha~     (TNF-α).~   "
65515|NCT02199808|"~     Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related~     changes in executive functions in children and older adults.~      Participants: Eighty-four typically-developing 7-to 12-year-old children.~      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three~     sessions will consist of the screening. These sessions will be telephone calls to collect~     24-hour diet information that will be used to determine whether they are eligible for the~     fourth session. Approximately 120 participants will be screened to find 84 participants who~     are eligible for the fourth session, in which participants will complete a series of tests~     on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device~     that provides computerized versions of standardized cognitive tests. They will also complete~     a maze task in which they figure out a path through the maze by walking on the correct~     squares. Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS)~     system.~   "
65516|NCT02199795|"~     This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos)~     and chronic (>6 mos) stroke survivors (n=18 total) with dorsiflexion weakness. The subjects~     will be stratified based on interval post-stroke and baseline level of motor impairment and~     then randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES)~     versus control. The primary objective of this study is to compare the effect of 6-weeks of~     lower extremity CCNMES, applied in an anti-phase application, on motor impairment and~     functional mobility to a control group; the effect of interval post-stroke, subacute (early)~     versus chronic (late) post-stroke, will be assessed. The secondary objective is to determine~     the effect of 6-weeks of lower extremity anti-phase CCNMES on functional magnetic resonance~     imaging (MRI) cortical activation patterns using an ankle dorsiflexion paradigm. The~     specific use of functional MRI as an outcome measure is to explore a central mechanism for~     between-group differences.~      AIM 1: Determine the effect of lower extremity CCNMES, applied in an anti-phase application,~     on motor impairment and functional mobility in hemiparesis compared to a control group;~     assess the effect of application in the subacute (< 6 mos, early) versus chronic (> 6 mos,~     late) post-stroke period.~      Hypothesis: Subjects randomized to the lower extremity CCNMES group will achieve greater~     improvement in motor impairment and functional mobility as compared to the control group;~     subjects in the subacute post-stroke period will achieve greater improvement than subjects~     in the chronic post-stroke period.~      AIM 2: Demonstrate change in functional MRI activation patterns using an ankle dorsiflexion~     paradigm following the lower extremity anti-phase CCNMES intervention.~      Hypothesis: Subjects randomized to the anti-phase CCNMES group will demonstrate change in~     functional MRI cortical activation patterns which differs from the control group; subjects~     in subacute post-stroke period will demonstrate change in functional MRI activation patterns~     that are distinct from change noted in chronic subjects.~      AIM 3: Define a central mechanism for post-stroke motor and functional recovery associated~     with lower extremity anti-phase CCNMES.~      Hypothesis: Change in functional MRI cortical activation patterns following anti-phase~     CCNMES intervention will correlate with change in motor impairment and functional mobility.~   "
65517|NCT02199782|"~     19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body~     providing services to the public in Wales has to prepare a scheme setting out how it will~     provide those services in Welsh.~      Diagnosing dementia requires a comprehensive assessment, an essential component of which is~     a cognitive assessment tool, which takes the form of a questionnaire. In clinical practice,~     this is currently only available through the medium of English.~      The investigators objective is to measure the difference between Cognitive Assessment scores~     (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those~     who are cognitively impaired and whose first language is Welsh. The investigators predict~     that there will be a significant difference in scores in favour of the Welsh-medium tests,~     thus proving that the current mode of administering the test is prejudiced against patients~     whose first language is Welsh.~      If the investigators predictions are correct, then the investigators would seek to introduce~     a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.~   "
65518|NCT02199769|"~     This study will focus on the cohort of 20,000 established patients cared for by 31 attending~     physicians in the outpatient, adult primary care practices at UT Southwestern (two general~     internal medicine one family medicine and one geriatric practice). The investigators will~     develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on~     electronic medical record (EMR) lab data to systematically identify all primary care~     patients with elevated random plasma glucose results (RPGs) who are at high risk of diabetes~     and thus in need of further testing. In a cluster-randomized trial, primary care providers~     will be randomized to either the intervention/DDT arm or usual care. Providers in the~     intervention arm will receive visit-based, EMR-enabled case identification and real-time~     decision support. Outcomes will be tracked at a patient level. All subjects will be followed~     for 12 months to assess rates of follow-up diabetes testing, time to testing, rates of~     subsequent diabetes diagnosis, and time to diagnosis. The investigators hypothesize that the~     visit-based provider decision support will be superior to usual care.~   "
65519|NCT02199756|"~     The purpose of the study is to find out whether indomethacin encapsulated within a~     nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a~     major contributor to newborn deaths. The treatment of preterm labor includes medications~     that stop contractions within the uterus, or womb. Indomethacin is effective in stopping~     uterine contractions, but crosses the placenta to the unborn baby causing problems for the~     baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be~     delivered directly to the uterus using a nanovector, it may be an ideal medication to treat~     preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine~     contractions.~   "
65520|NCT02199743|"~     24 individuals with schizophrenia or schizoaffective disorders, who are currently considered~     stable, will be recruited, screened for entry criteria into a blinded study with a 4-week~     randomization to either lurasidone, haloperidol, or perphenazine to examine~     glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.~   "
65549|NCT02199353|"~     To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL)~     Occupational Therapy programme on the independence of ADL by persons with dementia who are~     institutionalized. This programme is based on the recovery of the cognitive functions.~   "
65567|NCT02199119|"~     The purpose of this study was to describe the effect of 30 min TV viewing with or without~     simultaneous moderate exercise using a treadmill on subsequent subjective appetite,~     satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized~     that TV viewing during exercise immediately before mealtime affects food intake regulation~     through its effect on the control of appetite and satiation.~   "
65521|NCT02199717|"~     This pilot project was developed to investigate subjective and objective data related to the~     patterns of physical activity participation among hemophilia patients (FVIII or FIX) between~     the ages of 5 and 18 years. Physical activity participation among different levels of~     disease severity will be compared using accelerometers to calculate the amount of time spent~     in moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA;~     additionally, data will be collected from two validated questionnaires (PedHAL and 3 day~     physical activity recall). Current literature that relates level of physical activity to~     disease severity in the pediatric hemophilia population is limited. The information gained~     about the type and quantity of physical activity participation in children with varying~     levels of hemophilia will assist in the development of education and interventions to~     promote good physical activity and potentially examine the role of tailored prophylaxis.~   "
65522|NCT02199704|"~     The aim of the case series study is to explore if a self directed version of the Positive~     Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with~     psychosis who are parents.~   "
65523|NCT02199691|"~     The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate~     vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW~     conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.~      Primary objective:~        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine~          when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is~          given alone.~      Secondary objective:~        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate~          vaccine, when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV~          vaccines, compared to those when it is given alone~        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap~          vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared~          to those when Tdap vaccine is given with HPV vaccine only~      Observational objective:~        -  To describe the safety profile of MenACYW conjugate vaccine, compared to that of the~          licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV~          vaccines.~   "
65524|NCT02199678|"~     This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,~     placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of~     ketamine sublingual wafer in adult subjects who experience post operative pain after~     undergoing third molar extraction.~   "
65525|NCT02199665|"~     This phase I trial studies the side effects and best dose of selinexor and carfilzomib when~     given together with dexamethasone in treating patients with multiple myeloma that has~     returned or does not respond to treatment. Drugs used in chemotherapy, such as selinexor and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving selinexor, carfilzomib, and dexamethasone may be a better treatment for multiple~     myeloma.~   "
65526|NCT02199652|"~     Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are~     already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine~     Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The~     investigators hypothesize that patients receiving prazosin will have a greater reduction in~     suicidal ideation.~   "
65527|NCT02199639|"~     Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It~     aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain,~     El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the~     degree of injury, age, presence of inhibitors and the development of physical activity;~     identify the relationship between the functional deficit by clinical assessment performed~     with the use of validated measurement scales, the assessment of the degree of injury to~     specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their~     impact on gait in patients with hemophilia; and evaluate the factors that influence the~     perception of illness and quality of life of patients with hemophilia.~   "
65528|NCT02199626|"~     This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are~     candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System~     and the second generation of colon capsule in comparison second generation of colon capsule~     endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast~     ultrasonography (SICUS) and endoscopy (upper and lower).~      This study aims~        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the~          evaluation of pediatric Crohn's disease.~        2. To evaluate the safety of CCE-2 in pediatric CD.~   "
65529|NCT02199613|"~     The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated~     elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet~     as a simplification strategy for the treatment of HIV infection in HIV-infected subjects who~     have had previous antiretroviral treatment experience with multiple-drug regimens.~      We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will~     offer a safe and efficacious treatment simplification strategy for HIV positive patients~     currently receiving multiple-drug regimens to control their HIV infection.~   "
65530|NCT02199600|"~     This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.~   "
65553|NCT02199301|"~     Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been~     well-known that long-term IS inevitably causes various complication e.g. infection,~     toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and~     malignancies and so on. Tolerance induction showing graft function without maintenance IS~     has been considered as a final solution in the transplantation recipients. Tolerance~     induction can be achieved in KT recipients with donor hematopoietic stem cell~     transplantation (HSCT).~      In this study, adult patients (18 and more years of age) with a human leukocyte antigen~     (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for~     HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the~     time of nephrectomy for transplantation in donor. Donor BM is infused immediate~     post-transplantation at intensive care unit (ICU). Immunologic measurements including~     microchimerism study and protocol biopsy will be followed at several time points. IS will be~     tapered slowly and withdrawn over a period of several months.~   "
65531|NCT02199587|"~     The investigators would like to examine the contribution of medical clowns in routine~     medical procedures in the endocrine clinic. This will be the first time that will objective~     evaluate the effect of medical clown on stress hormone such as adrenaline cortisol and~     prolactin, and also evaluate the effect of mental stress on growth hormone secretion in~     children.~      The aim of the current study is testing the pain and anxiety of the patient and the~     accompanying parent and medical staff in the presence or absence of medical clown at the~     time:~        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.~        2. Growth hormone tests.~      Secondary end point will be:~        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone~          tests in the presence of a clown.~        2. Does the presence of a medical clown and the mental stress affect the secretion of~          growth hormone?~        3. Are there differences in growth hormone secretion and stress hormones between the~          various tests for growth hormone secretion (glucagon, clonidine or arginine) in the~          presence of a clown?~        4. Are there differences in response to stress and the secretion of growth hormone in~          children with obesity?~   "
65532|NCT02199574|"~     The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single~     dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for~     prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of~     the adenoids.~   "
65533|NCT02199561|"~     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for~     CD patients. Studies are now required to determine if repeated FMT can overcome the apparent~     immune response to FMT thereby maintaining sustained clinical improvement and remission.~     Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility~     study to determine if serial FMTs can sustain a clinical response and maintain stability of~     transplanted microbiota.~   "
65534|NCT02199548|"~     Adolescents with cancer weigh multiple influences in medical decision-making, including~     their own best interest, the perceived wishes of family members, and the interpreted~     preferences of the health care team. Parents of children with cancer often describe~     themselves as trying to be a good parent in making decisions in the child's best interest.~     Adolescents with cancer often describe themselves as trying to be a good patient and good~     child in making decisions in accord with how they believe a good patient and good child~     would decide.~      Among the challenges of caring for adolescents is the reality that the formative relational~     influences in adolescents' decision-making are both complex and unique due to adolescent~     patients' social networks and relational roles. Delineating adolescents' definitions of~     being a good patient, a good child, a good sibling, and a good friend may enable the care~     team to better understand the formative decisional influences relevant to adolescents with~     cancer. Expanding knowledge about the decision making constructs relevant to adolescents~     with cancer and recognizing the role of these social constructs in medical interactions has~     the potential for development of a comprehensive care model that methodically evaluates the~     self-assessed decision making influences and needs of adolescents at various stages in~     oncology care.~      This qualitative construct-defining study represents an initial step in the development of~     enhanced interventions for improved psychosocial support in this vulnerable population.~   "
65535|NCT02199535|"~     The aim of the study was to investigate the analysis of the risks faced by the personnel~     working in the field of Anesthesiology and Reanimation in Turkey~   "
65536|NCT02199522|"~     As we know propofol is popular use in the anesthesia induction with kilogram and it always~     cause hypotension. So we compare haemodynamic changes and drug consumption between propofol~     titrated administration and traditional administration for anesthesia induction.~   "
65537|NCT02199509|"~     Background:~      - People with dystonia cannot control their muscle contractions. This disorder can affect~     different body areas. When it affects the face, tongue, and jaw, it is called oromandibular~     dystonia (OMD) or cranial dystonia (CD). Researchers want to find out if a drug that treats~     seizures may help people with this kind of dystonia.~      Objective:~      - To see if levetiracetam can improve symptoms of jaw or face dystonia.~      Eligibility:~      - Adults ages 18 70 with OMD or CD.~      Design:~        -  Participants will be screened with a medical history and physical exam. Researchers~          will test how severe their dystonia is.~        -  Participants will have blood drawn through a needle in the arm.~        -  Participants will be assigned to take either levetiracetam or placebo.~        -  Phase 1:~        -  Participants will start with one 500-mg tablet twice daily. The dose will be increased~          by 500 mg every 3 days. The maximum dose will be 4000 mg a day over 3 weeks.~          Participants who cannot tolerate that will take the highest dose they can.~        -  Participants will return for study visits at weeks 3 and 6. They will be asked about~          their health, side effects, and symptoms of depression. They will have a neurological~          examination and test of their dystonia.~        -  After the week 6 visit, participants will taper and stop the study drug over about 1~          week.~        -  Phase 2 begins one week later. Participants will repeat phase 1, but with the other~          drug.~        -  After phase 2, participants will return to their usual clinics. They will be told how~          to stop taking the drug. They will have a follow-up phone call 2 weeks later.~   "
65550|NCT02199340|"~     The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in~     exercise capacity. The assessment of fitness and exercise capacity in CF is an important~     measure of the impact of the disease process, particularly if it is repeated over time. With~     recent advances in clinical management, CF lung disease in children can be relatively mild~     and exercise tolerance good. The currently available field tests e.g. 3 minute step test,~     are often completed too easily. These tests provide limited information relating to maximal~     exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a~     progressive, incremental, gold standard exercise test with breath by breath analysis of~     expired gas, has proved to be a valuable means of assessing exercise response in patients~     with CF. Its only limitation is the requirement for specialist laboratory facilities,~     equipment and staff.~      A new field test for evaluating exercise capacity in children is needed. This should be~     portable, easy to administer and simple to perform by young children, while providing a~     higher intensity of exercise which correlates with day to day activity patterns of children,~     and clinically relevant information in the short term and longitudinally. This test needs to~     be a good surrogate measure of exercise capacity when formal CPET is unable to be~     undertaken. By providing accurate and useful information the results can be used to~     prescribe and train individuals with CF safely and effectively and can also be used in the~     short and long term for guidance of the medical management of these complex patients.~      The aim of this study is to develop and validate the use of a new incremental step test to~     assess exercise tolerance/capacity in children with CF, compare this with the gold standard~     CPET and to provide normative healthy control comparison data The main objectives of the~     study are~        1. To develop an incremental step test to assess exercise tolerance / capacity in children~          with CF.~        2. To compare the incremental step test with the gold standard CPET~        3. To assess the level of exercise response produced by the incremental step test~        4. To assess the correlation between independent variables of lung function measurements,~          age, weight and height with VO2peak and other exercise test outcomes~        5. To assess the repeatability and evaluate the normal variability of the new incremental~          step test~        6. To provide healthy control normative data for comparison~   "
65538|NCT02199496|"~     Background:~      - Some people with Common Variable Immunodeficiency Disease (CVID) have gastrointestinal~     inflammation. This can cause diarrhea, weight loss, and not being able to absorb nutrition~     from food. Researchers want to see if the drug ustekinumab can help these problems. This~     drug blocks some proteins that cause inflammation.~      <TAB>~      Objective:~      - To test the safety and efficacy of the drug ustekinumab for people with CVID with~     gastrointestinal inflammation.~      Eligibility:~      - Adults ages 18-75 with CVID. They must have chronic diarrhea, have unintentionally lost~     weight in the last year, and/or need to use nutritional supplements to maintain their~     weight.~      Design:~      Participants will undergo the following screening studies to make sure that this study is a~     good fit for your medical situation, and to make sure it is safe for you to receive the~     study medications tests, including tests for HIV and hepatitis . This will be done as an~     inpatient at the NIH Clinical Center and takes about 5-6 days:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood tests, including tests for HIV and hepatitis.~        -  Stool tests, including a timed 48 hour collection for fat malabsorption and a 24 hour~          collection for protein malabsorption~        -  Urine tests, including a pregnancy test for any women with the ability to have a child~        -  Chest CT scan to look for infection~        -  D-xylose testing, which involves drinking a sugary solution and then having a blood~          sample drawn to test carbohydrate (sugar) malabsorption~        -  Hydrogen breath testing for test for small intestinal bacterial overgrowth (SIBO) this~          test also involves drinking a sugary solution and then collecting breath samples~        -  Upper endoscopy (EGD) and/or colonoscopy to look at the lining of the GI tract and take~          biopsies for testing. This will be done under sedation by a qualified~          gastroenterologist.~      Participants who complete screening and meet all criteria will then return to the NIH~     Clinical Center for the following visits:~      First Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital~     signs and weight, review of medications, and an assessment of number and consistency of~     stools each day. A pregnancy test for women of childbearing potential. A nurse will give you~     three shots of 90 mg ustekinumab (270 mg total dose) by very small needles injected under~     the skin, and then observe you for 1 hour.~      Week 8 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital~     signs and weight, review of medications, and an assessment of number and consistency of~     stools each day. Blood, urine and stool samples will be collected. A pregnancy test for~     women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a~     very small needle injected under the skin, and then observe you for 1 hour.~      Week 16 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital~     signs and weight, review of medications, and an assessment of number and consistency of~     stools each day. Blood, urine and stool samples will be collected. A pregnancy test for~     women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a~     very small needle injected under the skin, and then observe you for 1 hour.~      Week 24 Treatment and Mid-point Evaluation Visit (4-6 inpatient days): Medical history,~     physical exam, measurement of vital signs and weight, review of medications, and an~     assessment of number and consistency of stools each day. Blood, urine and stool samples will~     be collected, including repeating the d-xylose carbohydrate malabsorption testing, the 24~     hour stool collection for protein malabsorption and the 48 hour stool collection for fat~     malabsorption. A pregnancy test for women of childbearing potential. A nurse will give you~     one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then~     observe you for 1 hour.~      Week 32 Treatment Visit: Medical history, physical exam, measurement of vital signs and~     weight, review of medications, and an assessment of number and consistency of stools each~     day. Blood, urine and stool samples will be collected. A pregnancy test for women of~     childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small~     needle injected under the skin, and then observe you for 1 hour.~      Week 40 Treatment Visit: Medical history, physical exam, measurement of vital signs and~     weight, review of medications, and an assessment of number and consistency of stools each~     day. Blood, urine and stool samples will be collected. A pregnancy test for women of~     childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small~     needle injected under the skin, and then observe y...~   "
65539|NCT02199483|"~     Background:~      - Many people can lose weight by changing their diet or exercise. However, most people~     eventually regain the weight over time. This weight regain may be related to changes in~     metabolism as well as changes in the brain caused by weight loss. Researchers want to learn~     more about these changes.~      Objective:~      - To see how weight loss and regain affects the body s metabolism and the brain of obese but~     healthy adults.~      Eligibility:~      - Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one~     of several participating clinics or resorts.~      Design:~        -  Participants will first be screened at home through questionnaires and telephone~          interviews.~        -  Participants will then be screened at the NIH with blood tests, medical history,~          physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic~          resonance imaging (MRI) scan.~        -  At visit 1, participants will stay at the NIH and will:~        -  have MRI and PET brain scans.~        -  have body composition scans and measurements.~        -  give blood samples.~        -  eat a special diet.~        -  wear a physical activity monitor.~        -  provide a urine sample and body weight daily.~        -  drink a special type of water to measure calorie burn.~        -  wear a clear plastic hood over their head while lying down, to collect exhaled air.~        -  spend 24 hours in a room that measures oxygen and carbon dioxide.~        -  complete questionnaires and computer tasks.~        -  After visit 1, participants will give daily urine samples and weight and physical~          activity measurements from home. Then they will follow a lifestyle intervention for~          weight loss and give daily weight and activity measurements.~        -  Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program.~          Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each.~        -  Researchers will track participants weight and physical activity for up to 26 months~          after visit 2.~   "
65540|NCT02199470|"~     Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve~     glycemic control and decrease complications and rates of mortality. However, it can be~     succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of~     β-cell function by determining fasting levels of C-peptide and those after meal stimulus.~   "
65541|NCT02199457|"~     A medical device study to assess the clinical accuracy and equivalence to reference devices~     of the SVSS to satisfy the requirements of the recognised applicable international~     standards. The SVSS is designed to measure and display 5 vital signs: pulse rate, blood~     oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These~     results will be compared for accuracy with the results obtained using standard vital sign~     measurement equipment on the same subject.~   "
65542|NCT02199444|"~     The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by~     resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease~     (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are~     highly demanded. It has been reported that the phosphate binder sevelamer sequesters~     p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results.~     Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.~   "
65543|NCT02199431|"~     The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a~     single oral dose of Lu AF11167 with and without administration of multiple oral doses of~     itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic~     status as CYP2C19 extensive metabolisers~   "
65544|NCT02199418|"~     The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based~     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast~     cancer.~   "
65545|NCT02199405|"~     The incidence of cervical spondylosis on young people is increasing every year. Suffering~     from this disease will affect the normal life and learning of young people. Episode younger~     and incidence higher of this disease could increase health care spending of the government~     in the economy. Cervical spondylosis of cervical type is the main type of cervical~     spondylosis of young people. Patients of cervical spondylosis of cervical type always~     manifest the head, neck and shoulder pain accompanied by corresponding pressure point, the~     X-ray display of Upper cervical curvature change and instability of intervertebral joint~     performance ,and the dynamic lateral X-ray shows vertebral instability or trapezoidal~     change. The conservative treatment is the primary and preferred treatment of the disease.~      This study is designed as a random, control, single blind study. It will recruit 140 cases~     of cervical spondylosis of cervical type. Both the treatment group and the control group~     will be randomly assigned 70 cases. Patients in the treatment group will be treated by~     Massage of chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4~     weeks，and the control group by conventional massage and cervical traction. The total study~     includes 2 views that are baseline and post-4week intervention. At all of the 2 views, all~     participants will be examined range of motion of cervical vertebra, cervical curvature, and~     Surface Electromyography of neck muscles, and will be estimated scores of The Neck~     Disability Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill~     Pain Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to~     investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and~     Sishi Daoyin practice, and discover the correlation between these scales and these objective~     indicators to discover the indicators of early warning signs of cervical spondylosis of~     cervical type of young people.~   "
65546|NCT02199392|"~     The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy~     subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4~     and P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral~     administration of 24 mg lenvatinib to healthy volunteers.~   "
65547|NCT02199379|"~     The purpose of this multicenter, open-label, non-randomized, single, oral dose,~     sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg)~     administered to healthy subjects and to subjects with renal impairment.~   "
65548|NCT02199366|"~     This is a pilot study to determine if there are changes in heart function following~     completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance~     imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side~     effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and~     compare quality of life questionnaires.~   "
65556|NCT02199262|"~     Agitation in the intensive care unit can have multiple consequences. The investigators~     hypothesize that agitation and its consequences can be reduced by the introduction of a~     reminder aiming at guiding the management of agitation. The investigators also hypothesize~     that they can prevent agitation and its consequences by acting on patients environment with~     reafferentation and relaxation methods.~      The investigators' objectives are to test within a quality improvement project by a~     prospective randomized study:~        -  If by reducing the number of agitation episodes we reduce the number of harmful~          consequences.~        -  If the introduction of reafferentation and relaxation methods (music therapy or~          reflexology) can prevent the occurrence of agitation.~        -  If the introduction of a reminder on management of agitation can reduce the number of~          agitation episodes.~      This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for~     a total of 6900 hospital /days /year, in a tertiary teaching hospital.~      The study is organized in 3 phases:~        1. First phase: Baseline phase (Prospective analysis of the present situation)~        2. Second phase: Learning phase (Implementation of a reminder about the management of~          agitation and delirium )~        3. Third phase: Randomized Intervention (reminder alone vs addition of music or~          reflexology)~      The interventions are :~        1. Implementation of a reminder of guidelines of agitation diagnosis and management.~        2. Music intervention( see description below) + reminder~        3. Reflexology (see description below)+ reminder~      Agitation is monitored with two scales SAS and CAM-ICU(description below) . Harmful~     consequences and complications are systematically registered as well as medication and the~     use of contention methods.~      Adherence to the implemented monitoring and interventions is also regularly checked.~      Data are daily collected (see details below) Statistical analysis and power calculation (see~     below)~   "
65557|NCT02199249|"~     Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is~     assumed to disrupt the syndesmotic ligaments.~      The goal of operative treatment is to reduce the ankle mortise to restore normal joint~     kinematics. Syndesmosis repair can be performed using either open or closed reduction,~     combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated~     high rates of non anatomic reductions greater than 40%; therefore, open reduction will be~     performed in this study. Screw fixation is stable but concerns exist regarding potential~     excess rigidity.~      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated~     improvements in functional outcomes and reduction quality. Both open reduction and flexible~     TightRope fixation have considerable support in the literature in cohort studies but have~     not been compared to open screw fixation in a randomized controlled trial.~      In this multi centre randomized study, radiographic, economic and functional outcomes are~     compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open~     reduction screw fixation (OS)] of the syndesmosis.~   "
65558|NCT02199236|"~     The purpose of this study is to see what amount of radiation is safe to give to rectal or~     anal cancer patients who are being treated with a procedure called brachytherapy.~   "
65559|NCT02199223|"~     Evaluate the safety of regorafenib and panitumumab~   "
65560|NCT02199210|"~     The purpose of the project is to investigate the function of self-regulatory processes in~     anesthesiologists and how application of these processes influence performance in a crisis~     situation.The investigators intend to explore specifically the first phase of~     self-regulation, i.e. the forethought phase which describes processes related to strategic~     planning, goal setting, goal orientation, and outcome expectation. The investigators~     hypothesize that prompting forethought before engaging in a simulated massive transfusion~     crisis situation will result in better task performance in anesthesiologists.~   "
65561|NCT02199197|"~     Study of Radium Ra 223 dichloride with enzalutamide compared to enzalutamide alone in men~     with metastatic castration refractory prostate cancer~   "
65562|NCT02199184|"~     The goal of this clinical research study is to learn if adding ofatumumab/rituximab to the~     standard combination of DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine, and~     cyclophosphamide) can help control the disease in patients with newly diagnosed or~     relapsed/refractory Burkitt leukemia or relapsed/refractory ALL. The safety of this drug~     combination will also be studied.~   "
65563|NCT02199171|"~     This phase I trial studies the side effects and best dose of heated carboplatin given into~     the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian~     tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it~     directly into the area around the tumor during surgery may kill more tumor cells.~   "
65564|NCT02199158|"~     Purpose:~      To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to~     report its complications at 1-week and 1-month follow up in patients that did not achieve a~     satisfactory clinical angle opening despite patent laser peripheral iridotomy.~      Design:~      Prospective, Interventional case series~      Subjects:~      Patients with an occludable angle in more than two quadrants in dark room indentation~     gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle~     closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.~      Patients will undergo complete examination and AS-OCT before ALPI, one week and one month~     after it. We analyzed the images in a masked manner and took the angle measurements (AOD500,~     AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome~     measure to determine effectiveness.~   "
65565|NCT02199145|"~     Membranous Nephropathy (MN) is an auto-immune kidney disease and a common cause of nephrotic~     syndrome. About 30% of MN patients progress to end-stage kidney disease (ESKD) while 30%~     undergo spontaneous remission. The phospholipase A2 receptor (PLA2R1) is the major~     auto-antigen in idiopathic MN. Anti-PLA2R1 autoantibodies are found during the active phase~     of MN. Predictors of disease progression include high titers of anti-PLA2R1 autoantibodies~     and serum creatinine levels at presentation, as well as decline in renal function during the~     first six months of follow-up. Investigators identified new prognostic factors in a cohort~     of 41 idiopathic MN patients with nephrotic syndrome and anti-PLA2R1 autoantibodies at the~     time of presentation. During a follow-up of at least 36 months, 21 patients had a persistent~     nephrotic syndrome (group A) and 20 showed partial or total remission (group R). We first~     measured the cross-reactivity of their sera at the time of presentation to human, rabbit and~     mouse recombinant PLA2R1 by western blot. All patients exhibited reactivity against human~     and rabbit PLA2R1, but only some of them did against mouse PLA2R1. These results suggest the~     presence of distinct epitopes that are differentially conserved among PLA2R1~     orthologs.Investigators then set-up three parallel ELISAs using human, rabbit and mouse~     recombinant PLA2R1. All 41 MN patients showed activity in human and rabbit ELISAs at~     presentation but only 32 of them (78%) in mouse ELISA.They finally analyzed the association~     between anti-PLA2R1 titers at presentation in the different ELISAs and the subsequent~     clinical outcome. The mean anti-PLA2R1 activity was significantly different between group A~     and R in mouse ELISA but not in human and rabbit ELISA. Patients with anti-mouse PLA2R1~     activity over 605 RU (relative unit)/ml showed a significantly lower survival without~     doubling of serum creatinine or ESKD , but patients in the highest tertile of anti-PLA2R1~     activity in rabbit and human ELISA did not show a significant increased risk of renal~     failure progression. The results suggest that the specific detection of particular~     anti-PLA2R1 autoantibodies using the novel anti-mouse PLA2R1 ELISA can identify MN patients~     at risk for ESKD. The aim is to confirm these result on a prospective cohort.~   "
65566|NCT02199132|"~     Retrospective study of patients diagnosed with a nasopharyngeal carcinoma included in our~     data base care between June 1990 and September 2013.~      Our hypothesis is:~      Our series of patients with a history of nasopharyngeal carcinoma presents epidemiological,~     response rates to the different treatments and survival similar to those described in the~     literature~   "
65571|NCT02199067|"~     Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for~     permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the~     volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an~     total intravenous anaesthesia with propofol is done only by experience of the anaesthetist~     or according to pharmacokinetic models. In this study we want to investigate if the exhaled~     fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled~     propofol will be measured with an electrochemical sensor developed by Drägerwerk AG & Co.~     KGaA. Exhaled propofol levels will be compared with the corresponding arterial serum~     concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol~     levels with the Bispectral Index (BIS).~   "
65572|NCT02199054|"~     This research study is being done to help researchers develop new dietary options for~     menopausal women to maintain a healthy weight by developing more nutritious snacks that have~     health benefits. From this study, the researchers hope to gain understanding on how~     menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its~     own and when combined with soy. The research team hypothesize that the two different types~     of pretzels may be processed by your body differently and that components in the pretzel~     snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and~     soybeans contain many natural chemicals that may benefit human health. However, this~     relationship is not well understood. This study will look at the impact of the pretzel~     snacks on your blood fat and glucose levels as well as a group of chemicals found in soy~     called isoflavones. Isoflavones are natural chemicals found commonly in soybeans or foods~     made from them.~      Participants will be screened to determine if they qualify in meeting the study~     requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or~     wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy~     protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of~     this study. The study will require five visits to the Ohio State University Clinical~     Research Center (CRC) which part of the Ohio State University's Center for Clinical and~     Translational Sciences. Once the investigators have determined that you qualify for this~     study and you decide to participate, you will be consuming three different pretzels each for~     one month, starting with a control pretzel. After the control pretzel treatment period, you~     will be randomly assigned (like the flip of a coin) to start with one of the two pretzel~     groups (wheat or soy pretzel with safflower oil) for your first treatment period and then~     switch to the other safflower oil pretzel at your second treatment period.~   "
65573|NCT02199041|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched~     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin~     receptors (KIR) ligand mismatched haploidentical donor identified, will receive a combined T~     cell depleted (TCD) haploidentical peripheral blood stem cell (PBSC) and unrelated umbilical~     cord blood transplantation (UCBT) using a total lymphoid irradiation (TLI) based preparative~     regimen.~      Primary objective:~        -  To estimate the incidence of donor derived neutrophil engraftment by day +42~          post-transplant for participants with high-risk hematologic malignancies undergoing a~          total lymphoid irradiation (TLI)-based hematopoietic cell transplantation (HCT) using a~          T cell depleted (TCI) haploidentical donor peripheral blood stem cell (PBSC) donor~          combined with an unrelated umbilical cord blood (UCB) donor.~      Secondary objectives:~        -  Estimate the incidence of malignant relapse, event-free survival (EFS), and overall~          survival (OS) at one-year post-transplantation.~        -  Estimate the incidence and severity of acute and chronic graft versus host disease~          (GVHD) in the first 100 days after transplantation.~        -  Estimate the incidence of secondary graft failure transplant related mortality (TRM)~          and transplant related morbidity in the first 100 days after HCT.~   "
65574|NCT02199028|"~     This research study examines the effect of hyaluronidase on the length of time of insulin~     infusion set wear. The aim of the study is to improve the length of time that an infusion~     set can be worn by infusing hyaluronidase directly into the insulin infusion site. The~     investigators will also assess the accuracy of the Dexcom G4 Platinum (G4P) sensors with~     extended sensor wear beyond the 7 day FDA approved time frame.~   "
65575|NCT02199015|"~     The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS)~     causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing~     spasticity and the spastic syndrome in selected cases of patients with cerebral palsy~   "
65576|NCT02199002|"~     Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of~     adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors~     (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this~     therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not~     fully understood, there is currently no adequate therapy available.~      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs~     from a reservoir of acid floating on top of the meal: the so-called acid pocket. In this~     study, we aim to investigate further the acid pocket by determining its exact position and~     chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI~     therapy and GERD patients with barrett's esophagus.~   "
65577|NCT02198989|"~     40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression~     in the community will be recruited and stochastically divided into the intervention group~     and the control group. Both groups will take the same group education courses including DSME~     (Diabetes Self-management Education), psychological support, improvement in sleep. Patients~     in the intervention group will receive peer support and yoga music therapy before bed. The~     observation period will last for 6 months so as to evaluate the benefits of peer support and~     yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic~     patients with sleep disorders and mild depression.~   "
65578|NCT02198976|"~     The purpose of this study is to collect prospective observational data regarding endoscopic~     management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia~     and/or intramucosal carcinoma. To observe the natural history of patients with low grade~     dysplastic and non dysplastic Barrett's oesophagus~   "
65579|NCT02198963|"~     The purpose of this study is to determine the skin irritation potential of RUT058-60 after~     repetitive patch application to abraded and non-abraded skin of human subjects.~   "
65580|NCT02198950|"~     The purpose of this study is to determine wether the combined measurement of the soluble~     form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose~     sepsis in critically ill patients.~   "
65581|NCT02198937|"~     Investigation on the effect of smoking on thrombus formation in humans. The expression of~     pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50~     year old healthy smokers and non-smokers. The investigators are interested in possible~     differences between the two groups.~   "
65582|NCT02198924|"~     In mainland China, knee Osteoarthritis (OA) is the leading cause of disability in older~     persons. Total knee arthroplasty (TKA) is now generally regarded by orthopaedic surgeons and~     patients as an effective treatment for end-stage knee OA in order to relieve pain, correct~     joint deformity and improve the life quality of patients.However, TKA has been called as one~     of the most painful Orthopedics surgery due to the weight bearing characteristics of knee~     joint and the high demand of functional exercise within the 6-8 weeks post operation. The~     targeted application of selective cyclooxygenase (COX) -2 inhibitor, such as Parecoxib or~     Celecoxib, can significantly reduce the level of inflammatory reaction one and two days~     postoperation . In addition, the perioperative administration of Celecoxib can directly or~     indirectly relieve postoperative pain, improve articular function and eventually augment~     life quality of the patients . Recently, effective treatment of post-operative pain with~     intravenous followed by oral COX-2 specific inhibitor has been demonstrated in many~     post-operative pain models . Significant morphine sparing effect and reduction of opioid~     distressed symptoms were also observed. In China, many surgeons have accept it as a routine~     strategy for controlling pain post TKA to sequentially give parecoxib 40 mg intravenously~     twice daily for the first 3 days post surgery and then Celecoxib 200mg orally twice daily.~     Although satisfactory results of this combination treatment on short-term pain reduction and~     functional improvement has been observed in clinical practice, high quality evidence is~     still lacking to prove its effect on the medium or long-term functionality recovery. This~     study is being conducted to investigate the combination regimen with intravenous parecoxib~     followed by oral celecoxib for post-surgical analgesic treatment in osteoarthritis patients~     undergoing total knee arthroplastic (TKA) surgery. Subjects will receive double-blinded~     study medication consisting of parecoxib injection in analgesic doses or matching placebo~     followed by oral celecoxib in acute pain doses or matching placebo in a double-blinded~     fashion. The hypothesis is subjects treated with parecoxib/celecoxib will consume less~     morphine over the first 24 hours of postoperation period, achieve improved pain control over~     study period, a quicker return to functionality, and has less opioid adverse events than~     those treated with opioids alone over 6-week recovery phase.~   "
65583|NCT02198911|"~     The purpose of this study is to examine if chewing gum before an eating bout will increase~     the rate of habituation and subsequently reduce energy intake within the eating bout.~   "
65584|NCT02198898|"~     This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea~     and the investigators hypothesized applying of adhesive preventing agent would reduce~     incidence of adhesive obstruction after gastrectomy.~   "
65585|NCT02198885|"~     The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch~     Technologies) provides a means of transmitting ultrasound images, video, and audio to a~     remote location in real-time. It has been envisioned that this system be used to diagnose~     trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal~     blockage during prehospital care; under the guidance of in-hospital physicians, paramedics~     would perform an Focused Assessment with Sonography for Trauma (FAST) examination while~     trauma patients are transported to hospital via ambulance. The investigators hypothesize~     that in-hospital physicians interpreting ultrasound images obtained by paramedics during~     trauma patients' transportation to hospital will reduce time to diagnosis; thus,~     preparations by emergency physicians, surgeons, and operating room teams to receive~     critically injured patients may begin earlier, reducing time to intervention during a~     critical period in patient care. Data will also be collected regarding quality of images~     obtained in-ambulance and the interaction between paramedics and physicians using the~     remote-presence system.~   "
65586|NCT02198872|"~     In the pathophysiological process of coronary artery disease (CAD), are present, autonomic~     dysfunction and reduced functional capacity. Studies showed that physical training (PT) is~     critical in the treatment of CAD by promoting beneficial effects. Although water based~     exercises program have been documented in patients with various cardiovascular diseases, the~     most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To~     evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic~     modulation of heart rate (HR), body composition and cardiorespiratory and metabolic~     variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD~     diagnosed by coronary angiography showing obstruction greater than 50% and underwent~     angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical~     assessment, body composition analysis and recording of HR and NN intervals during rest. 2)~     The components of step 1) will be repeated after three month, adding the record of HR and NN~     before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise~     testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48~     sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus,~     it is expected that WPT promote beneficial physiological adaptations in CAD patients with~     obstruction greater than 50%.~   "
65587|NCT02198859|"~     Laboratory testing has suggested that lithium may decrease the incidence of certain types of~     cancer, including prostate cancer. Additional research has suggested that lithium decreases~     prostate cancer tumor size over time. This study will investigate the effect of lithium on~     men with prostate cancer.~   "
65588|NCT02198846|"~     Insulin deficiency resulted from progressive beta cell failure and insulin resistance in~     type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic~     agents. Previous data have been suggested that continuous subcutaneous insulin infusion~     (CSII) does not only have efficacy in glucose control but also restore beta cell failure.~      The investigators plan to compare the efficacy/safety and beta cell function between insulin~     pump treatment and the intensification of conventional treatment in patients with~     uncontrolled type 2 diabetes.~   "
65589|NCT02198833|"~     The purpose of this study is to determine if the study Foley catheter with its patterned~     external surface can delay the time to the onset of urinary tract infection in spinal cord~     injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.~   "
65590|NCT02198820|"~     Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital~     between October 1th 2014 and September 30th 2015.~      Comparison of severity scores of these patients and the scale of Nottingham on immediate~     (day 1 and day 2) and late (1 month) outcome.~   "
65591|NCT02198807|"~     The objective of this study is to explore the role of fosmidomycin and piperaquine as~     non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when~     administered over three days.~      Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by~     meeting the three key parameters of having different modes of action and different~     biochemical targets while exhibiting independent blood schizonticidal activity. Like the~     artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active~     against existing drug-resistant parasites. Piperaquine has a long half life protecting~     fosmidomycin as a much shorter lived molecule against selection of resistant parasites and~     will provide post-treatment prophylaxis.~   "
65592|NCT02198794|"~     The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of~     SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe~     tardive dyskinesia.~   "
65593|NCT02198781|"~     This is a pilot study into the effects on heart function when pacing the right ventricle~     (RV). This study aims to enrol a population who are clinically indicated to receive a~     pacemaker.~      When normal conduction within the heart fails, the treatment may be to implant a permanent~     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical~     impulse to stimulate a beat.~      Increasingly the available evidence suggests that long term RV pacing is associated with~     complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF)~     and death in some patients. What we do not see are a large proportion of all patients who~     receive pacemakers suffering pacing related adverse effects.~      If there could be a way of identifying those patients in the group who go on to develop~     pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very~     valuable clinical measure. These patients could be identified from the outset and paced with~     a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has~     been directed towards the LV as a focus of the clinical markers of disease, little has been~     published looking at RV haemodynamics.~      We plan to study a cohort of patients who are clinically indicated to receive a pacemaker~     and study their RV in detail at the time of implantation. We will use conductance catheters~     and echocardiography to determine measures of pumping function. We will then follow them up~     for a period of six month using echocardiography and blood markers of heart dysfunction. In~     those patients who have a reduction in heart function we will then look for common patterns~     within their initial measurements.~   "
65594|NCT02198768|"~     The purpose of this study is to compare outcomes of patients with an ankle fracture to those~     with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for~     patients sustaining ankle fracture dislocations are poorer than those without dislocation.~   "
65595|NCT02198755|"~     The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the~     diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of~     HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.~   "
65596|NCT02198742|"~     The study is a randomized crossover study where anesthesia practitioners will intubate three~     different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome~     anatomy) using three different intubation devices (the Miller blade, the Truview VL, the~     Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an~     immobile neck). The order of presentation will be randomized. As this is a cross over study,~     all subjects will complete all scenarios. There is no placebo group, and each subject wil be~     his or her own control.~   "
65597|NCT02198729|"~     The investigators have recently become proficient in a new, and we believe more effective~     technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves~     removing the polyp in one piece. It is preferable to remove the polyp in one piece as it~     minimises the chance of leaving residual polyp tissue behind. There have also been recent~     studies overseas that have shown this new technique to be quite effective. In this study,~     half of the patients will receive the newly developed technique of polyp removal (ESD),~     while the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment.~     This study will allow us to show which technique results in lower recurrence rates and is~     more effective.~   "
65598|NCT02198716|"~     The treatment of complex coronary disease causing limiting symptoms of angina with~     drug-eluting stent technology will prove superior to bare metal stent technology, with~     respect to a combined endpoint of mortality, MI, requirement for target vessel~     revascularisation and severe haemorrhage, in patients aged 80 or above.~   "
65599|NCT02198703|"~     This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic~     blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.~   "
65600|NCT02198690|"~     The aim of this study is to test whether an educational pamphlet on mammography designed for~     women aged 75 and older improves older women's decision-making around mammography screening.~     The investigators aim to show that the educational pamphlet improves older women's knowledge~     of the pros and cons or screening and leads to fewer women in poor health with short life~     expectancy being screened.~   "
65601|NCT02198677|"~     The aim of the investigators study is to investigate whether posteriorly directed (AP)~     pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation~     or lowering in patients with neck pain. The answer will advance the investigators~     understanding of why manual therapy works.~   "
65602|NCT02198664|"~     This is a multi-center, open-label, follow-on study to gather additional information on the~     safety and tolerability of oral desensitization with CPNA in the subjects who participated~     in ARC001.~   "
65603|NCT02198651|"~     A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging~     TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of~     Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA).~   "
65604|NCT02198638|"~     Hospital acquired influenza is associated with significant morbidity and mortality in~     hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent~     influenza transmission in healthcare setting.~      Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage~     in patients (higher than 85%). It is necessary to underline that an adequate vaccine cover~     in the elderly population will not necessarily result in a total control of the incidence.~     Consequently, the prevention of influenza outbreaks in this vulnerable population must also~     include the reduction of the exposure to the influenza viruses, in particular thanks to the~     vaccination of HCW.~      A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University~     hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital~     acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results~     suggest a protective effect but investigations, carried out on a more important sample are~     needed to validate the benefit of HCW vaccination.~      The aim of this prospective multicentric cohort study is to estimate incidence of influenza~     among hospitalized patients according to % of influenza vaccination of HCW in short stay~     units.~   "
65605|NCT02198625|"~     The purpose of this study is to determine the influence of moderate FiO2 and the lung~     protective ventilation on postoperative pulmonary complications following hepatic resection~     surgery.~   "
65606|NCT02198612|"~     Over the past years, arterial closure systems have tended to replace manual compression to~     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce~     hemostasis and patient immobilization times, thus enabling early resumption of walking.~     These devices have contributed extensively to the development of outpatient stays for~     cardiology, vascular and neuro-radiology procedures.~      According to certain studies however, it would appear that arterial closure devices do not~     present any greater benefits than manual compression in terms of hemostasis and~     complications. Moreover, the use of increasingly small diameter instruments would tend to~     render manual compression sufficient. Finally, the use of these devices generates additional~     costs.~      The purpose of our study is to evaluate the feasibility and safety of manual compression~     before early resumption of walking in patients managed by conventional hospitalization for a~     diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F~     guide catheter.~   "
65607|NCT02198599|"~     Objectives: This parallel RCT investigated the effect of a new nursing intervention~     (Mobility Enhancing Nursing Intervention - MFP) designed to improve the rehabilitation~     programs' outcomes and patients' quality of life.~      Intervention: The IG combined standard care with the 30-day mobility-enhancing-nursing~     intervention (MFP). MFP placed patients on a mattress on the floor and used constant~     tactile-kinaesthetic stimulation in everyday tasks to increase spatial orientation, to teach~     patients to get up safely and to move independently.~      Primary and secondary outcome measures: Outcomes were defined as functionality (Extended~     Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I).~   "
65608|NCT02198586|"~     The purpose of this study is to investigate the influence of the APOE genotype on brain~     morphology, function and metabolism, related to other factors such as cognitive reserve,~     cognition and episodic memory, in subjects at greater risk of developing AD.~   "
65609|NCT02198573|"~     -  Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin~          resistance containment measures have been launched since 2009-2010.~        -  It is important to monitor the spread and magnitude of artemisinin resistant malaria in~          Myanmar.~        -  So, day-3 surveillance study have been conducted.~        -  Recently artemisinin resistant molecular marker, K13 have been identified and it was~          used as a tool in this study.~   "
65610|NCT02198560|"~     The primary objectives of the study are to assess the agreement between the two different~     scan mode of the RS-3000 Lite.~   "
65611|NCT02198547|"~     The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time~     and can enhance offset time.~   "
65612|NCT02198534|"~     A) For the investigation of Visual acuity, inter-test agreement and the test-retest~     reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart~     and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice~     but the sequence of the visual acuity tests were randomize and so different for each~     examinee. The examinees were 24 adult Aalen university students (except students of~     ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with~     correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a~     maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C~     was projected in eight-orientations. For the FrACT Test we used two different devices for~     response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt~     device with an adjustable Landoltring (FrACTh). The primary objective was the comparison~     between FrACTk and FrACTh. The secondary Objective contains the comparison between all~     visual acuity tests.~      B) Background: Landolt Cs and letters are commonly used optotypes. In the explorative study~     we compare four different ways of applying them: The Freiburg visual acuity test (FrACT)~     using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and~     DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to~     determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the~     inter-test agreement between the tests and test-retest reliability of the tests, concerning~     the test duration.~      Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were~     included in the explorative study. The visual acuity of one eye was measured monocularly,~     randomized with regard to the leading/non-leading eye. The subjects passed every visual~     acuity test twice in a randomized sequence of the visual acuity tests, which is maintained~     by a pre-specified randomization list, making use of forced choice.~   "
65613|NCT02198521|"~     Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis~     Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in~     overall pain intensity of pain between sides.~      Secondary null hypotheses~        -  There is no correlation in overall pain intensity after open CTR surgery and distal~          sensory latency, distal motor latency, electromyography (EMG), demographics,~          occupation, avocation, relevant comorbidities, dominance, left vs. right, Pain~          Self-Efficacy, Patient Reported Outcomes Measurement Information System (PROMIS) Upper~          Extremity or PROMIS depression when both surgeries are performed within 6 months.~        -  There is no difference in satisfaction with treatment at the time of suture removal~          after the first and second open CTR surgery when both are performed within 6 months..~      IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors:~     Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study~     Background Many hand surgeons note that patients undergoing staged bilateral open carpal~     tunnel release often experience more pain with the second side. The investigator felt this~     was an easily testable hypothesis worthy of study.~      Subjects~      Eligibility:~      Inclusion:~        -  Age 18 or older~        -  Idiopathic carpal tunnel syndrome~        -  No prior surgery for carpal tunnel syndrome~      Exclude:~        -  Pregnant women~        -  Not fluent in English~      Response Variables:~        -  11-point ordinal measure of overall pain intensity during and after surgery measured at~          the time of suture removal.~        -  11-point ordinal measure of satisfaction with treatment~        -  PROMIS upper extremity~      Explanatory Variables:~        -  Distal Sensory Latency (DSL)~        -  Distal Motor Latency (DML)~        -  EMG changes~        -  Demographics: age, sex, race, occupation, avocation~        -  Time limit between two surgeries < 6 months~        -  Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger~          finger~        -  Involved hand (Dominance, Side)~        -  First side vs. second side surgery~        -  PROMIS Pain Interference Computer Adaptive Testing (CAT)~        -  Pain Self Efficacy Questionnaire (PSEQ-2)~        -  PROMIS Depression~      Methods The investigator and study staff will invite all adult patients (age 18 and older)~     presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts~     General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral~     carpal tunnel release.~      Analysis Power analysis An a priori power analysis for matched pairs was performed. To~     detect the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and~     80% power, a total sample size of 34 patients is needed.As the investigator expects to have~     patients who will be lost to follow-up the investigators will count 10% extra, a total of 38~     patients will be needed.~      Univariate analysis: Variables will be presented with frequencies and percentages for~     categorical variables and as mean with standard deviation or median with interquartile range~     for respectively normal or non-normal distributed continuous variables. Normality of~     continuous distributed variables will be tested a paired T-Test.~      Bivariate and multivariable analysis will be performed and subsequently all variables with a~     probability < 0.10 in bivariate analysis will be inserted in a backward, stepwise,~     multivariable linear regression analysis to assess their ability to explain variation in~     outcome. The 11 point Likert Pain scale score is considered significant when there is a~     difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]~   "
65614|NCT02198508|"~     Background: Three iron chelators now available on the market differ in toxicity and organ~     specificity; evidence on standardized chelation protocol remains inconclusive, but patients~     with transfusion-dependent beta-thalassemia treated with DFO infusion show significant~     differences in the limitations of daily activities, physical activity, and quality of life~     when treated with oral chelator. With licensing of DFP in America, it is reasonable to~     combine DFP with DFX. Patients find two oral chelators more acceptable than one oral and one~     injectable. This pilot study rates use of DFP for improving iron excretion profile of~     deferasirox.~      Methods: The investigators enrolled 13 beta-thalassemia patients in China Medical University~     Children's Hospital in May 2009-October 2011. Five refused to take part in pharmacokinetics;~     they only participated in iron excretion study. Seven with irregular bowel function were~     unable to collect feces in the screening period as baseline data. Subjects were randomly~     assigned and rotated to undergo all treatments (with informed consent): (A) single oral dose~     of DFX 30 mg/kg once daily, (B) single oral dose of DFP 40 mg/kg twice a day, (C) oral doses~     of DFX and DFP administered sequentially (DFX 30 mg/kg/d, deferiprone 40 mg/kg/d and~     deferiprone 40 mg/kg/d at 7-hour intervals). Three-day drug dosage was followed by four-day~     washout. Collections of urine and stool proceeded 24 hours per day, each analyzed~     separately. Through a venous catheter, serial blood samples (1 mL/each sampling) were~     collected in glass tubes containing heparin as anticoagulant at Time 0 (pre-dosing) and at~     0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 7, 8, 10, 12 and 24 hours after dose; plasma~     concentrations of DFP and DFX were measured.~   "
65615|NCT02198495|"~     Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron~     supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels~     with or without additional use of erythropoiesis-stimulating agents (ESA).~      The investigators aim to compare two different intravenous iron preparations, ferric~     carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary~     objective is to assess whether both agents are equally effective to maintain a target~     haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin,~     transferrin saturation, and how much ESA therapy is administered.~      Patients will be randomly assigned to either treatment group and followed in parallel over~     an active study period of 40 weeks.~   "
65616|NCT02198482|"~     Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) in~     Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid~     Leukemia (AML)~   "
74932|NCT02076529|"~     This study is designted to know optimal dose of Ramosteron to control for chemotherapy~     induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and~     clinilcal parameters using Rhodes Index.~   "
65617|NCT02198469|"~     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few~     cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy~     prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative~     fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may~     improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with~     and without Er:YAG AFL in treating AC~   "
65618|NCT02198456|"~     The aim of the study is to intensify the follow up of patients with pulmonary arterial~     hypertension via modern imaging guided methods in due consideration of the possibilities of~     three-dimensional echocardiography in order to optimize their specific therapy.~      The hypothesis is that the increased use of modern imaging guided tools is essential for the~     follow up.~   "
65619|NCT02198443|"~     The main objective of this study is to compare the tolerability and adherence to a new drug~     regimen of post-exposure prophylaxis (PEP) for HIV,~   "
65620|NCT02198430|"~     Multidisciplinary assessment of the physical, functional and psychosocial alterations in~     patients with hemophilia around the country. The aims of this study are:~        -  Descriptive study of joint involvement in hemophilia patients with and without a~          history of hemarthrosis.~        -  Descriptive study of the alterations of periarticular muscle strength as a result of~          acute processes or the development of chronic articular sequelae.~        -  Descriptive study of biomechanical changes in lower limb joints and their impact on~          gait in patients with hemophilia.~        -  Descriptive study of the joint space, regarding hemarthrosis and synovitis,~          intraarticular by ultrasonography.~        -  Descriptive study of the relationship between skeletal muscle pathology in patients~          with hemophilia and their perceptions of it and their quality of life.~   "
65621|NCT02198417|"~     PCOS occurs when a woman does not release an egg regularly each month, causing her periods~     to be irregular. Women with PCOS can also have increased hair growth on the face and body,~     acne, head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with~     oral contraceptive pills (also known as the birth control pills). Sometimes, a medication~     called metformin is also used to treat PCOS, especially if a woman has evidence of insulin~     resistance or if fertility is desired. Unfortunately, metformin works in only some women~     with PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult~     to predict who will benefit from metformin treatment and who will not.~      The investigators are doing this research study to look at how the medication metformin~     affects the cells in the body of patients with PCOS. Specifically, the investigators will~     look at how metformin affects the mitochondria. Mitochondria are the part of cells that~     produce fuel (energy) for other cells and play a role in metabolism. The investigators would~     like to see whether there is a relationship between mitochondrial activity and symptoms of~     polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also~     like to study whether genes affect the response to metformin in women with PCOS.~   "
65622|NCT02198404|"~     In the palliative care unit, certain patients suffer from pain associated with medical~     procedures/care which is poorly controlled by antalgics. These situations may necessitate~     temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,~     either in the literature or in clinical studies conducted, on the choice of sedative agent~     however Midazolam is the general recommendation.~      The investigators believe that Propofol could be used in this instance~   "
65623|NCT02198391|"~     This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two~     dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.~   "
65624|NCT02198378|"~     In the management of acute coronary syndromes with ST-segment elevation (STEMI), early~     analgesia reduces the effects of hyperadrenalism which increases the size of myocardial~     infarction. In order to reduce pain intensity, the recommendations advocate emergency use of~     morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at~     least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely~     used in emergency medicine and has minor secondary effects that are very rapidly reversible~     when inhalation is discontinued. Used in association with paracetamol, it could be an at~     least equally effective alternative to the use of morphine.~   "
65625|NCT02198365|"~     The investigators hypothesis is HPV integration could result in expression of oncogene~     transcripts, and not only constitutive expression but also the level of expression will be~     decisive for transformation and the maintenance of the malignant phenotype. Moreover, the~     expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the~     severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).~   "
65626|NCT02198352|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing~     doses in healthy male and female volunteers~   "
65627|NCT02198339|"~     Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a~     single acute migraine attack with or without aura~   "
65628|NCT02198326|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing~     doses in healthy male and female volunteers~   "
65629|NCT02198313|"~     The objective of the present study is to obtain information about the safety and~     tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary~     pharmacokinetic data~   "
65630|NCT02198300|"~     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary~     interventions (PCI) and are associated with higher rates of periprocedural complications as~     well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting~     (PTS) is the best treatment strategy at the moment. However, the optimal approach to~     coronary bifurcations treatment is still a subject of debate, especially when the side~     branch is large, not easily accessible and narrowed by a long lesion. One of the proposed~     alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of~     randomized trials with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation~     Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland)~     was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is~     verified.~   "
65631|NCT02198287|"~     Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.~   "
65633|NCT02198261|"~     Topical minoxidil is the most common drug used for the treatment of AGA in men. While~     topical minoxidil exhibits a good safety profile, the efficacy in the overall population~     remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair~     growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to~     the significant time commitment and low response rate, a diagnostic test to identify~     non-responders prior to initiating therapy would be advantageous.~      Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the~     sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We~     have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in~     plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus~     can server as a predictive biomarker.~      Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify~     non-responders prior to initiating therapy with 5% topical minoxidil foam.~      The primary purpose of this study is to evaluate the clinical validity of the minoxidil~     response in-vitro diagnostic kit.~   "
65634|NCT02198248|"~     Previous reports suggested conventional immunosuppressants such as cyclophosphamide could~     not reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because~     of lower remission rate and higher relapse rate. However those reports didn't include~     rituximab.~      B cell depletion therapy by rituximab is a new strategy for remission induction in~     ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose~     glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose~     glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational~     studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe~     relapsing ANCA-associated vasculitis.~      Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose~     in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy~     between low-dose and high-dose glucocorticoid plus rituximab). Participants will be~     randomised to the low-dose glucocorticoid plus rituximab or the high-dose glucocorticoid~     plus rituximab groups. Primary endpoint is proportion of remission at 6 months, then data~     regarding relapse and long-term safety will be collected until 24 months.~      The study has been designed by the principal and coordinating investigators. It will include~     140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and~     Chiba East Hospital.~   "
65635|NCT02198235|"~     This study looks at addition of medications to the local anesthetic for the nerve blockade.~   "
65636|NCT02198209|"~     Type 2 diabetes is a chronic disease that has reached epidemic proportions. In order to~     improve our strategies for preventing and treating type 2 diabetes the investigators need to~     better understand the mechanism of this disease, and the way in which current therapies,~     such as the drug liraglutide, work to control blood sugar. It is known that liraglutide acts~     via increasing the secretion of the hormone insulin from the pancreas, hormone that in turn~     controls blood sugar. However, it is not known whether liraglutide also has actions on the~     liver. Animal studies have suggested that liraglutide might act by controlling the liver~     enzyme glucokinase (GCK), an enzyme that increases blood sugar uptake by the liver. This~     could be a crucial mechanism in which liraglutide controls blood sugar independently of~     insulin, thus making it beneficial not only in type 2 but also in type 1 diabetes. The~     effect of liraglutide on GCK activity has not been yet measured in humans. The investigators~     propose to investigate the acute and chronic effect of liraglutide on GCK by using a simple,~     widely used procedure (an IntraVenous Glucose Tolerance Test-IVGTT) and a novel approach~     (mathematical modeling of data obtained from this procedure), to assess GCK activity in~     people with type 2 diabetes. The investigators will first compare data obtained form 2~     IVGTTs (with and without liraglutide) performed 1 week apart (acute effect). The~     investigators will then give liraglutide to patients for 6 weeks and do another IVGTT to~     measure GCK activity (chronic effects). Data obtained from this study will be used to~     further understand the mechanism of liraglutide action and how to better employ our current~     therapeutic options and develop new strategies for preventing and treating diabetes.~   "
65637|NCT02198196|"~     The purpose of this study is to explore the efficacy of a phone-based weight loss program~     that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The~     program is targeted at employees of certain companies who meet a cut-off score on a measure~     of stress-related eating. The control group will receive a standard phone-based program with~     no additional stress management information (Weight Talk-Standard).~        -  Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience~          decreases in their stress-related & emotion-related eating compared to the Weight~          Talk-Standard (WT-S; n=25) group.~        -  Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.~        -  Hypothesis 3: Participants in WT-M will experience decreased perceived stress,~          increased eating self-efficacy, increased acceptance of weight-related thoughts &~          feelings and increased mindfulness compared to those in the WT-S control arm.~        -  Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss~          program as those in WT-S.~   "
65638|NCT02198183|"~     The purpose of this study is to measure cerebral oxygenation and cardiac output of total~     shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure~     ventilation (PPV).~      We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare~     during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is~     well maintained under GA in the sitting position when epinephrine is used, but that~     decreased cardiac output increases the risk of cerebral desaturation.~   "
65639|NCT02198170|"~     The purpose of this study is to assess the influence of simultaneous CYP3A4 and~     p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5~     mg lenvatinib.~   "
65650|NCT02198027|"~     Patients may feel significant pain at the surgery site after they wake up from the surgery.~     Usually pain is managed in the ward by giving strong pain medication that may slow down your~     mobilization and recovery process. Some recent work in other countries has shown that if~     investigator give patients an injection at the end of the operation, patients have less need~     for pain medication when they wake up. If investigator find that is also true in our~     population, then we can use this method as routine step after this operation to improve pain~     management and early mobilization of our patients~   "
65640|NCT02198157|"~     -  Labor is divided into three stages: the first stage is from labor onset until full~          dilation, second stage is from full dilation until delivery of the baby, and the third~          stage from the delivery of the baby until the delivery of the placenta~        -  The mean duration of second stage in nulliparas as defined by the American college of~          obstetricians and gynecologists (ACOG) is 54 minutes~        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.~          Prolonged second stage in nullipara women with epidural is defined as more than 3~          hours, and more than 2 hours in those without epidural.~        -  Although perinatal outcome is not compromised with a prolonged second stage , there is~          evidence that maternal morbidities such as perineal trauma, chorioamnionitis~          ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage~        -  Another effect of epidural anesthesia during labor is urinary retention and a need for~          catheterization.~        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the~          birth canal, increasing by that the duration of the second stage.~        -  This study aims to investigate the effect of intermittent versus continuous~          catheterization on the duration of the second stage of labor~   "
65641|NCT02198144|"~     African American men have the highest risk of any group for early death & disability from~     high blood pressure (BP). Clinical investigations in Dallas, TX demonstrated that African~     American men with high BP are able to improve their BPs when participants agree to have~     their BP measured at their barbershop by their barber & also take BP reducing medication as~     instructed by a healthcare team that includes their doctor. The goal of this study is to~     bring a barbershop-based model of BP measurement, treatment & follow-up from Dallas, TX to~     the Southern California area. This study is the 2nd of two Barbershop studies at~     Cedars-Sinai Medical Center. The 1st study was called the Barber-Based Intervention for~     Hypertension in Black Men: Baseline Data Collection. In this 2nd study at Wally's~     barbershop, the Investigators will enlist pharmacists to integrate the community health~     promotion program in barbershops into the healthcare system. Barbers are uniquely positioned~     to facilitate hypertension case detection & referral, pharmacists are uniquely positioned to~     facilitate case management. Pharmacists have extensive knowledge of BP medication & they~     have earned the respect of patients and physicians alike. In this intervention study,~     barbers will be trained to measure the BP & refer those who have already been identified as~     having high BP to a community pharmacist for confirmation of uncontrolled high BP &~     development of a BP management plan. The pharmacist will work with the customers' physicians~     to optimize the BP medication prescribed & with individual customers to provide a~     user-friendly medical home. Pharmacists will improve the customer's access to~     state-of-the-art medical care, The data from this study will be used to apply for a new NIH~     Grant. In addition, the summarized data will be shared with key stakeholders in the local~     community (including barbers, patrons, local healthcare providers, local pharmacists & other~     community leaders) to design a larger community-partnered intervention.~      Specific Aims:~      Aim 1. To evaluate the impact of the new intervention model on HTN control in African~     American males.~      Aim 2. To evaluate the cost-effectiveness of the new intervention. The investigators~     hypothesize that the projected cost-savings to the healthcare system in reduced heart attack~     & stroke care will outweigh intervention & medication costs.~   "
65642|NCT02198131|"~     This pilot trial studies pulsed dye laser in treating patients with post radiation~     dysphonia. Dysphonia, or vocal cord scarring, can include trouble with the voice when trying~     to talk, such as hoarseness, change in voice pitch, and poor voice quality, and it commonly~     happens after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post~     radiation dysphonia.~   "
65643|NCT02198118|"~     Background: Breast cancer is the most common type of cancer among women. Its treatment,~     including radiotherapy (RT), can cause potential complications to be treated by the~     physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper~     limb applied during the period of radiotherapy in women submitted to surgical and~     radiotherapy for breast cancer. Study design: This is a prospective randomized controlled~     clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March~     2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after~     the end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm~     circumference. They were divided into two groups: CG) control group, submitted only to the~     assessments and SG) study group, submitted to domiciliary physiotherapy.~   "
65644|NCT02198105|"~     Observational registry including patients with peripheral artery disease due to~     femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent~     drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).~   "
65645|NCT02198092|"~     This is an observational, case-control study evaluating the quantitative level of Septin9 in~     plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients~     (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple~     Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family~     members as controls and references.~   "
65646|NCT02198079|"~     To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric~     patients with cystic fibrosis in the State fo Florida. HYPOTHESIS: There is high prevalence~     of NTM in CF pediatric population in the State of Florida, and likely higher than in the~     rest of the country.~   "
65647|NCT02198066|"~     The purpose of this study was to determine which of three types of dressings, a dry sterile~     dressing, a metallic silver dressing or an ionic silver dressing provided better patient~     outcomes for the post-sternotomy cardiac surgery patient population. In this prospective,~     randomized controlled trial, the hypothesis was that subjects who received either of the~     silver impregnated dressings would have better outcomes (better wound healing, less~     discomfort, and less incidence of infection). Investigators also evaluated dressing factors~     such as adherence, time for application and ease of use.~   "
65648|NCT02198053|"~     Different antiplatelet drugs played various role in coronary artery disease. The mechanisms~     were unclear. Platelet reactivation maybe was one of major causes. Compared with~     clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased~     bleeding and dyspnea risk, both loading double dose and following second dose time had~     potential risk and inconvenient in routine clinical work, especially in elective PCI of~     comparable stable patients in Chinese. The benefit and risk should be balanced in such~     patients. The investigators supposed loading single dose and followed by second routine time~     dose was superior to clopidogrel and safer than ticagrelor previously prescribed.~   "
65649|NCT02198040|"~     The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one~     with joint traction, passive muscles stretching and Proprioceptive Neuromuscular~     Facilitation (PNF), and the other with education sessions and home exercises, for the~     improvement of the ROM, biceps strength, perimeter of arm and the perception of pain in PwH~     and arthropathy of the elbow.~   "
65660|NCT02197897|"~     Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors~   "
74956|NCT02076217|"~     This project will quantify rates of contraceptive failure when unprotected intercourse~     occurs 5-14 days prior to initiation of highly effective reversible contraceptives (such as~     IUD's and Implants).~   "
65651|NCT02198014|"~     This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual~     therapy using joint traction, passive muscle stretching, and isometric exercise, active~     resisted and proprioception exercises; and other treatment with educational sessions and~     home exercises to improve the ROM, muscle strength and proprioception in patients with~     haemophilia and arthropathy of the knee.~   "
65652|NCT02198001|"~     This prospective study will include patients taking or having taken bisphosphonates and~     needing dental extractions.~      The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth~     extraction sites.~      In the test group (PRF) and in the control group (no PRF), we use the same atraumatic~     extraction protocol associated with the same antibiotic procedure.~   "
65653|NCT02197988|"~     The purpose of this study is to compare two standard methods of pain control management used~     at Spectrum Health for patients undergoing major surgery. The two methods being compared are~     the thoracic epidural and the TAP block. The thoracic epidural method involves medication~     being given through a patient's back and the TAP block involves medication being given~     through a patient's abdomen (belly). The investigators will compare side effects experienced~     by the patients that take part in this study, including a change in blood pressure, as well~     as the patients' opinions about their pain management experience after surgery.~   "
65654|NCT02197975|"~     Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese~     Descent Following a Single Dose and After Chronic Dosing for 7 Days.~   "
65655|NCT02197962|"~     The objective of this study is to compare the results of 2000 impulses of radius shockwaves~     per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of~     patients with severe primary knee osteoarthritis, who did not satisfactory respond to~     previous conventional treatments.~   "
65656|NCT02197949|"~     At present, patients diagnosed of a breast cancer with infiltration of the axillary~     lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)~     technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the~     surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The~     reason for not performing SN is that patients diagnosed of an infiltrated axilla though~     ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed~     after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant~     systemic treatment and the axillary clinical exploration is negative after the treatment,~     different studies showed that the SN false negative rate is unacceptably high.~      Despite these facts, a high proportion of patients with a positive axilla at diagnosis and~     submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated~     in the pathological study, frequently four or less neoplastic nodes. New methods of~     detecting these patients with limited infiltrated nodes should be developed and new~     approaches to axillary surgery (i.e., partial resection) should be offered.~      To date, the only information expected to get after an axillary imaging is performed is if~     the axilla is infiltrated or not. No information about the tumoral load is demanded. In the~     other hand, level I and II ALND is performed according to established anatomic limits,~     without selecting the nodes to be excised neither identifying the ones infiltrated for a~     directed excision.~      The aim of the study is to evaluate the ability of a specified and reproducible imaging~     protocol for distinguishing patients with a high axillary tumoral load from the ones with a~     low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be~     the ones commonly affected, identifying these nodes injecting diluted methylene blue in the~     retroareolar parenchyma and studying their tumoral load could help selecting patients with~     high from those with low axillary tumoral load.~      Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue~     protocol), could eventually help to distinguish which patients should be submitted to a~     classical level I and II ALND and which ones can be spared from excising the lymph nodes not~     stained by the methylene blue.~   "
65657|NCT02197936|"~     Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and~     the role of correct peristalsis is most important for correct sperm transport towards the~     fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time,~     an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and~     may also account for heavy menstrual bleedings and menstrual pain.~      In this study, the uterine peristalsis of women with adenomyosis will be investigated. This~     condition is associated to heavy menstrual bleeding, menstrual pain and infertility.~   "
65658|NCT02197923|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been~     correlated with adenomyosis.~      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as~     local hyperestrogenism and elevated levels of prolactin (PRL) have been identified, but~     autoimmune and mechanical factors are also hypothesized.~      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic~     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin~     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation~     have been tried, but studies are few in number, retrospective, and have small sample sizes.~      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of~     adenomyosis remains still unclear, there are not many satisfying treatment options and~     diagnostics include mostly magnetic resonance imaging (MRI) and histology.~      The investigators designed a series of 3 studies with a broad approach in understanding~     adenomyosis. This is part 2.~      In this study the investigators take both tissue samples and blood samples that will be~     investigated in order to understand the basic processes leading to adenomyosis.~   "
65659|NCT02197910|"~     In this study we will assess the effects of bioactive peptide rich wheat products on blood~     pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,~     cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The~     intervention will be based on commercially-packaged pasta, which will appear and taste the~     same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion~     Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV~     risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40~     and 70 years old; Primary prevention for CVD but otherwise in good general health and have~     had no major illness in the previous 6-months; Volunteer providing their signed and dated~     informed consent form. Exclusion Criteria will be: Severe medical illness/chronic~     disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;~     Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other~     related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin~     supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be~     recruited and following adherence to a standardized diet for a 4-week period, will be~     randomly assigned to complete one of 2 treatment sequences by consuming a prescribed~     quantity of pasta products for a 4-week period followed by a 4-week washout before random~     assignment to the 2nd treatment.~      The Primary Outcome will be the modification of office blood pressure (assessed by systolic~     and diastolic BP, pulse and mean pressure (mean of 3 standing & sitting measures) and~     24-hour blood pressure.~      Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),~     Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios),~     Estimated CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA,~     PWV, Aix), Liver and renal functionality biomarkers, 24-h urine collection at baseline of~     treatment phase 1 and endpoint of the final phase will be analysed to account for potential~     confounding of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the~     SOPs have already been established and all the personnel to be involved in the study is~     continuously trained in trials with similar outcomes~   "
65661|NCT02197884|"~     The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4~     inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a~     drug enters and leaves the blood and tissues over time) of single dose of JNJ-54861911 in~     healthy male participants.~   "
65662|NCT02197871|"~     Insufficient energy intake and systematic inflammation lead to malnutrition in patients with~     chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the~     patients'nutritional status by increasing energy intake and providing anti-inflammatory~     elements，which can relieve the patients' symptoms and delay the disease progression.~   "
65663|NCT02197858|"~     During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood~     pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called extended~     hemodynamic monitoring depending on the operation and patient. Frequently an invasive~     arterial cannula is used to provide continuous information on the blood pressure. This~     invasive method is very accurate and clinically established, but can be linked to adverse~     effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection~     etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a~     non-invasive manner. It thus offers beat-to-beat information even about the extended~     hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV),~     stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical~     platform EV1000 (Edwards Lifescience).~      Assuming that the two methods are equal we plan to measure extended hemodynamic parameters~     before, during induction and during ongoing anesthesia both invasive and non-invasive. Data~     will be recorded every 30sec.~      Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters~     is to our knowledge rare and further assessment in this field is needed to offer patients a~     potentially equally reliable but less invasive monitoring. Furthermore the study should~     model the effect of remifentanil, propofol or its combination on haemodynamics .~   "
65664|NCT02197845|"~     Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of~     Virginia to demonstrate:~        1. the feasibility of using patient navigators to improve the percentage of children and~          adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care~        2. the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation~          and adherence among adult patients with SCD eligible for HU~      (Patient navigators may also be known as public health workers.)~   "
65665|NCT02197832|"~     This is a randomised controlled trial on the effect of endometrial injury in the cycle~     preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that~     endometrial injury will increase the ongoing pregnancy rate in FET cycles.~   "
65666|NCT02197819|"~     Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2%~     in the general population. In young patients, recurrence after a primary dislocation is also~     common (~60%) and multiple recurrent episodes can cause significant disability over time.~     Following initial reduction of the joint, the traditional treatment for primary shoulder~     dislocations has been immobilization in a sling, with the arm in a position of adduction and~     internal rotation. The length of the immobilization period is controversial, however most~     authors would recommend between three to six weeks in a sling followed by several months of~     rehabilitation to include range of motion and strengthening exercises. The clinical course~     of patients after this approach has been extensively investigated. Of particular interest is~     the relatively high rate of recurrent instability in young patients, reported to be between~     17 and 96%.~      A prospective randomized trial is needed to determine whether in young patients (16-30 yrs~     of age) following reduction of a first-time traumatic anterior shoulder dislocation, does~     EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external~     rotation reduce the rate of recurrent instability experienced within 12 months versus~     emergent immobilization in a traditional internal rotation sling? Eligible patients will be~     randomly allocated to the sling or ER brace. The results of this study will provide the best~     evidence for choosing emergent immobilization for shoulder dislocations.~   "
65667|NCT02197806|"~     A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and~     concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus~     for near vision).~   "
65668|NCT02197793|"~     The purpose of this study is to evaluate the impact of a community mobilization intervention~     on the uptake of HIV testing, linkage to and retention in HIV care using a community,~     cluster randomized trial.~   "
65669|NCT02197780|"~     RATIONALE:~      A substantial proportion of children and teenagers with suspected inflammatory bowel disease~     (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical~     decision rule that included a calprotectin stool test to discern which patients require~     further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of~     missing IBD cases. Although the number of negative endoscopies was reduced after~     introduction of this strategy, still 22% of the referred children and teenagers underwent an~     unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted~     exclusively by activated neutrophils and this stool marker may be more IBD-specific than~     calprotectin.~      OBJECTIVE:~      To determine whether the specificity of S100A12 is superior to the specificity of~     calprotectin without sacrificing sensitivity~      HYPOTHESIS:~      Inclusion of the calgranulin C stool test will improve the specificity of the~     screening-strategy.~   "
65670|NCT02197767|"~     Will use of Rituximab reduce proteinuria over a 12 month period and will there be~     preservation of kidney function with the use of this study drug?~   "
65671|NCT02197754|"~     There are two primary objectives to be addressed in this study: to assess the differential~     response in bioavailability and metabolic pathways between lean and obese individuals~     exposed to acute, short term (14 day), and long-term (10-week) consumption of~     polyphenol-rich fruits (berries and apple), and beverages (tea); and to determine the~     differential systemic and gut anti-inflammatory response between obese and lean individuals~     exposed to polyphenol-rich fruits (berries and apple), and beverages (tea).~   "
65686|NCT02197559|"~     The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis~     than Bare-metal stents after Vertebral Artery Ostium stenting~   "
68465|NCT02161159|"~     This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in~     patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms~     have not been adequately managed by oral anticholinergic therapy.~   "
65672|NCT02197741|"~     An additional, intermittent bolus application in patients with intrathecal opiate~     administration for chronic pain syndrome may have a positive effect on the effectiveness of~     the treatment. Thus, the effect of an additional, intermittent bolus application in patients~     with intrathecal opiate administration was therefore investigated.~      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each~     patient was submitted to two treatment periods in randomly chosen order (cross-over design):~     1. standard treatment (continuous opiate administration) and 2. continuous opiate~     administration with intermittent opiate bolus application. Both treatment periods lasted 14~     days. Patients were asked to record pain intensity, side effects and satisfaction with the~     treatment.~      The following hypotheses were tested:~        -  The application of additional opiate boli results in significantly lower pain~          intensity.~        -  The application of additional opiate boli does not result in a higher rate of adverse~          Events.~   "
65673|NCT02197728|"~     We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy~     reduces operative time (from skin incision to detachment of the uterus) and lateral termal~     damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine~     manipulation is better with the Hohl manipulator®, thereby facilitating dissection during~     all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,~     thereby hastening electrosurgical transection, reducing activation time and reduce lateral~     thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,~     due to the tight connection between the Hohl manipulator® and the cervix of the uterus,~     which also affects speed of transection, electrosurgical device activation time and lateral~     thermal damage.~   "
65674|NCT02197715|"~     This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an~     intervention designed to increase acceptance of and adherence to contraceptive practices~     among opioid-agonist-maintained women of childbearing age. The intervention will be~     delivered in one of two formats: a face-to-face brief intervention approach or a novel~     computer-adaptive platform. To the extent that either version of SAFE is found to be~     efficacious compared with usual care, it has the potential to reduce the number of~     unintended pregnancies and consequently decrease the need for and the costs of child~     protective services.~   "
65675|NCT02197702|"~     In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks~     triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5~     months during their usual clinic visit. This study will test whether children receiving a~     high dose of vitamin D have less frequent and less severe asthma exacerbations compared with~     those receiving placebo.The study will also document the safety profile of this strategy.~   "
65676|NCT02197689|"~     Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare~     system around the world with many countries in Europe and the United States using it as a~     benchmark. However, increasing medication costs over the past two years account for more~     than 25% of total expenditure, surpassing every OECD member and mounting increasing pressure~     on the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the~     investigators assessed the effectiveness of a personalized medication management system for~     improving the medication adherence for patients, in order to save long term medication~     costs.~   "
65677|NCT02197676|"~     Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow~     blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6~     courses, or relapse after initial response.~   "
65678|NCT02197663|"~     The lifestyle of Taiwanese people has been changed over the past decade with the improvement~     of economic growth, environmental sanitation and the quality of medical care. Now the~     investigators pay more attention to the increasing risk of people's diseases of civilization~     than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular~     accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the~     patient of cerebrovascular accident cause a lot of money and is a burden of our country.~      Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with~     cerebrovascular accident. The investigators use some scales to assess efficacy of~     acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual~     Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating~     Scale.~      Besides, the investigators notice that there are few journals about acupuncture effect of~     treating depression following cerebral vascular accident. The investigators may~     underestimate the amount of people having post-stroke depression. So the investigators use~     Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular~     accident patient.~      By assessing bio-psycho-social level of CVA patient, the investigators hope this study will~     offer them more Holistic Health Care.~   "
65679|NCT02197650|"~     Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for~     patient unable to receive any other form of Asparaginase.~   "
65680|NCT02197637|"~     The purpose of this study is to determine whether oral vinorelbine is effective in the~     treatment of children with progressive or recurrent unresectable low grade glioma.~   "
65681|NCT02197624|"~     The two specific aims of this study are: 1) to assess the impact of a genetic variant on~     iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian~     women. The investigators hypothesize that the genetic variant could enhance iron status and~     iron absorption in Asian women.~   "
65682|NCT02197611|"~     Research project for the development, construction and validation of a questionnaire of~     adherence to treatment in adult patients with hemophilia. It aims to build a scale according~     to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2)~     knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences~     and difficulties, and 5) benefits of treatment.~   "
65683|NCT02197598|"~     The purpose of this study is to explore the treatment effects of Selincro in alcohol~     dependent patients with liver impairment.~   "
65684|NCT02197585|"~     To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.~      Hypothesis: Glue may induce less complications and chronic pain than suture~   "
65685|NCT02197572|"~     The purpose of this study is to characterize the effect of a single dose of 40 mg MLN0128 on~     the electrocardiographic QT/QTc interval in participants with advanced solid tumors.~   "
65687|NCT02197546|"~     Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients~     experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and~     distress in children receiving an injection of a local anaesthetic (LA). Children scheduled~     for dental treatment using local anesthesia as a standard treatment, received bilateral~     acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the~     patients stimulated the needles by massage. Two different treatment regimes were compared: a~     standardized LA injection given 5 minutes after acupuncture, and an LA injection without~     acupuncture. The order of treatment was randomised, with the two treatments performed on~     different days. Pain intensity during LA injection, assessed by the patient with the Verbal~     Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and~     dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction~     with the received therapy were also recorded.~   "
65688|NCT02197533|"~     Background: Overactive bladder (OAB) is a common condition among postmenopausal women,~     requiring a multifaceted treatment approach that requires patient retention of information~     given to them in clinic. Recall of recommendations is a key component of compliance.~     Supplemental educational tools such as handouts and audiovisual information have been~     investigated for their ability to improve patients' recall of information and increase~     satisfaction with the clinical encounter.~      Objective: To determine if a written list of seven management strategies for overactive~     bladder leads to improved immediate and delayed recall of these recommendations in~     postmenopausal women presenting with OAB compared to a traditional verbal discussion.~      Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed~     (2-week) recall of seven OAB management strategies will be compared between two groups. The~     intervention group will receive a handwritten list during their verbal discussion of OAB~     treatment while the control group will receive standard care (verbal discussion only).~     Immediate and delayed recall will be assessed by a member of the study team who has been~     blinded to participants' group assignments.~      Results: The results of this study may guide clinicians in the most effective mode of~     providing treatment recommendations to post-menopausal patients with OAB.~   "
65689|NCT02197520|"~     This study will look into insulin sensitivity (how the body responds to insulin) and effects~     of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has~     two treatment periods, each of which will last about four weeks. One drug (insulin peglispro~     or insulin glargine) will be administered in each period. Participants will receive both~     drugs during the study. Participants may remain on stable dose metformin, as prescribed by~     their personal physician.~   "
65690|NCT02197507|"~     Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults.~     Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are~     also validated questionnaires for self-assessment of the disease by the patient. Grip~     strength measured using a digitized sensor used by the patient could be an additional tool~     to the remote monitoring of patients with RA.~      Main Objective : To evaluate the correlation between the measurement of grip strength in the~     dominant hand measured by a digital sensor and activity of RA assessed by DAS 28~      Secondary objective : Evaluate the correlation between grip strength of the dominant hand~     and :~        -  scores of fatigue and pain (VAS and FACIT)~        -  the self-assessment scores known in RA : functional index Health Assessment~          Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.~      It is a cross-sectional study involving 150 patients followed in our department for RA. Grip~     strength of the dominant hand will be measured by a digitalized sensor during a single visit~     integrating into the routine monitoring of patients.~   "
65691|NCT02197494|"~     The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,~     single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg~     under fed conditions.~   "
65692|NCT02197481|"~     The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps~     hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic~     resection.~   "
65693|NCT02197468|"~     Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants~     in the neonatal intensive care unit (NICU). It has been postulated that abnormal~     colonization of the preterm gut, or an unfavorable balance between gut bacteria may~     contribute to the development of NEC.~      Recent clinical randomized studies and meta-analysis have shown that proactive colonization~     of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all~     Norwegian NICUs started routinely administration of probiotics to all extremely premature~     neonates susceptible to NEC (gestational age <28 weeks/birth weight <1000g).~      The current project is investigating the gut microbiome in patients receiving probiotics and~     compare the the gut microbiome with moderate premature infants not receiving probiotics. In~     addition, we are including a control of healthy full-term infants.~      Samples containing feces from participants will be analyzed by state of the art whole-genome~     sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.~      Study hypotheses:~        -  Probiotics given to extremely preterm infants will change the biodiversity of the gut~          microflora.~        -  Antibiotics given to these patients may influence the gut microflora also in infants~          receiving probiotics. In particular use of vancomycin may change the gut flora.~        -  After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics~          will gradually resemble the gut flora of infants not receiving probiotics.~        -  A cross-contamination of probiotic bacteria between patients treated with probiotics~          and patients not treated with antibiotics may occur.~   "
65694|NCT02197455|"~     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus~     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia~     areata and its variants.~   "
65695|NCT02197442|"~     The study was an open label, balanced, randomized, two-treatment, four-period, two sequence,~     single oral dose, crossover, fully replicate bioequivalence study of two formulations of~     Valsartan 320 mg under fasting conditions.~   "
65696|NCT02197429|"~     A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture~     protocol for the treatment of vulvodynia.~      Hypotheses:~        1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.~        2. Acupuncture increases sexual function in women with vulvodynia.~   "
68466|NCT02161146|"~     This study will evaluate the safety and efficacy of AGN-229666 for the prevention of~     allergen-mediated conjunctivitis.~   "
65699|NCT02197390|"~     Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by~     the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level~     approaches to prevent and control childhood obesity. Our Choice is translating~     evidence-based approaches for modifying behaviors, policies, systems, and environments to~     promote fruit and vegetable consumption, physical activity, water consumption, and quality~     sleep. The ultimate goal is to assist Children's Health Insurance Program-eligible children~     between 2-12 years old attain a healthy weight. In addition to site-specific intervention~     and evaluation activities, Our Choice is working with the University of Houston Evaluation~     Center to conduct a cross-site evaluation on a set of shared measures.~   "
65700|NCT02197377|"~     With an aging population a prevalence of edentulous patients increased above 60 % among~     individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often~     difficult because of the inadequate fitting of the standard mask to the face. In addition,~     because of a reduction in muscle tone under general anesthesia, the air space in the~     oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis~     tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to~     the standard face mask if the facial contours of the patient are not suited to the standard~     face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than~     in patients with intact dentition. The laryngeal mask airway (LMA) provides a better~     alternative to the standard face mask if the facial contours of the patient are not suited~     to the standard face mask.~      We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™~     with the newly released LMA Supreme™ in edentulous elderly patients for the success in first~     attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.~   "
65701|NCT02197364|"~     The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the~     clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among~     patients with ILD, and comparing them to the clinical diagnostic criteria and other~     respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of~     ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment~     and after treatment.~   "
65702|NCT02197351|"~     It is thought that the development of cancer of the stomach follows a series of stages in~     which the lining becomes increasingly abnormal. Early detection of precursors of gastric~     cancer likely enable less invasive treatment.~      The assessment of gastric mucosa using the endoscope is used to detect cancers and these~     precursor lesions. Narrow band imaging uses filtered light already built into modern~     endoscopoes to identify the early changes in the gastric lining.~      The investigators' hypothesis is that narrow band imaging improves detection of precursor~     lesions and is a method amenable to international standardization.~      The investigators will conduct a prospective trial in which standard random biopsy, white~     light guided biopsy, and narrow band imaging guided biopsy will be performed for each~     patient. The yield of the different methods for gastric cancer precursors will thus be~     compared.~   "
65703|NCT02197338|"~     1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove~          bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.~        2. Given the small size of the bile duct orifice and its close proximity to the pancreatic~          duct, selective biliary cannulation is the most difficult part of the endoscopic~          retrograde cholangiography (ERCP).~        3. New small diameter sphincteromes and short wire systems (which allow physicians to~          control guidewires) offer potential, though untested advantages.~        4. At most hosptial both the long and short wire systems as well as small versus standard~          are routinely used for clinical care.~        5. Our hypothesis is that small diameter, physician controlled wires favor biliary~          cannulation~        6. Our objective will be to assess whether small diameter sphincterotomes and short wire~          physician controlled guidewire cannulation favors successful bile duct cannulation and~          minimize complications.~   "
65704|NCT02197325|"~     The purpose of this research study is to find out whether PICSO (Pressure Controlled~     Coronary Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI~     and stenting, can improve final infarct size and myocardial function.~      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according~     to standard treatment, PCI followed by stent placement, with or without PICSO therapy. In~     NSTEMI patients, PICSO therapy will be given during PCI and stenting for a minimum of 30~     minutes or the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will~     be given after successful primary percutaneous coronary intervention of a left anterior~     descending coronary artery culprit lesion. PICSO therapy is initiated prior to stent~     deployment and continued during stenting. The functional efficacy measures, related to the~     PICSO duration and coronary sinus pressures, will be stored on the PICSO Impulse console and~     analysed offline. The clinical efficacy measures, cardiac enzyme release during 24 hour~     following PCI, cardiac function, infarct size and level of microvascular obstruction will be~     assessed by cMRI. Patients will be followed for a maximum of 4 months after the primary PCI~     procedure~   "
65705|NCT02197312|"~     Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide~     partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a~     veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate~     after 5 years~   "
65706|NCT02197299|"~     A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by~     the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance).~     Insulin resistance can be caused by the accumulation of fat within muscle of overweight~     individuals. The aim of the present research is to test whether a novel nutritional~     intervention containing L-carnitine can increase the amount of carnitine within muscle of~     individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning~     fat' within our muscles and it is hoped that increasing the amount of carnitine within~     muscle can increase fat burning, lower muscle fat, reverse insulin resistance and ultimately~     lower blood glucose levels and wellbeing. We also aim to investigate the cellular mechanisms~     underlying any observed effects in a hope to identify further targets to lower muscle fat.~   "
65892|NCT02194842|"~     The objective of this randomized phase III open label trial is to assess if upfront~     combination of enzalutamide and Ra223 improves radiological progression-free survival~     compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration~     resistant prostate cancer patients metastatic to bone.~   "
65707|NCT02197286|"~     A ten week, blinded trial of vitamin D vs. placebo in 80 patients with schizophrenia or~     schizoaffective disorder who have low blood levels of vitamin D and elevated blood levels of~     the amino acid proline. The aims of the study are to evaluate an anticipated clinical~     response to vitamin D supplementation including negative symptoms and cognitive deficits,~     evaluate safety of vitamin D supplementation for schizophrenia patients and evaluate the~     relationship of changes in plasma proline levels and efficacy outcomes.~   "
65708|NCT02197273|"~     The purpose of this study is to determine whether liposomal bupivacaine is effective in the~     management of pain following total joint arthroplasty, as compared to standard of care~     analgesia.~   "
65709|NCT02197260|"~     It is common practice to carry out the therapy of periodontal diseases in two phases. In a~     first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are~     removed using a cleaning method called scaling and root planing (SRP). After three to six~     months the case is evaluated and, if necessary, further treatment is provided, usually~     taking a more aggressive, surgical approach. Beneficial effects of adjunctive systemic~     antibiotics on clinical outcomes have been shown repeatedly but specific indications for~     antibiotics in subgroups of diseased patients, and the optimal timing of antimicrobial~     therapy, continue to be issues of a long lasting controversy.This study assessed the~     differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole~     during either the non-surgical or the surgical treatment phase.~   "
65710|NCT02197247|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung~     cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine~     kinase inhibitor (TKI) agent.~      Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of~     AZD9291 and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin~     and AZD9291 in a fasted state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients who complete Part A will be able~     to enter part B, and continue to receive AZD9291 80 mg once daily until: disease~     progression; they are no longer deriving clinical benefit; or any other reason.~   "
65711|NCT02197234|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung~     cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine~     kinase inhibitor (TKI) agent.~      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of~     simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted~     state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients from Part A who completed~     treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they~     are no longer deriving clinical benefit; or any other reason.~   "
65712|NCT02197221|"~     Phase III multicenter randomized, open-label study comparing the efficacy of a combined high~     dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem~     cell transplant in frontline multiple myeloma patients, non-progressive after induction~     therapy.~   "
65713|NCT02197208|"~     This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in~     frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural~     cycles.~   "
65714|NCT02197195|"~     The purpose of the study is to understand the role chocolate milk compared to a fruit drink,~     with and without exercise, on glycaemic regulation and subjective appetite in children. The~     investigators hypothesize that chocolate milk in combination with exercise will have the~     greatest effect attenuating glycaemic response. Blood glucose will be measured by finger~     prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65~     minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.~   "
65715|NCT02197182|"~     LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL~     Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered~     intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..~   "
65716|NCT02197169|"~     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of~     malignant primary brain tumor in adults and can be resistant to conventional therapies. The~     purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or~     gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified,~     conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered~     directly into the tumor where it may establish an active infection by replicating in and~     killing tumor cells.~   "
65717|NCT02197156|"~     The purpose of the study is to establish a dose-response relationship among several capsule~     strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to~     placebo following bunionectomy surgery~   "
65718|NCT02197143|"~     -  Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency~          physicians in Turkey for the treatment of patients with dyspepsia.~        -  The objective of the study was to assess whether intravenous esomeprazol has superior~          dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency~          department (ED) adults~        -  The investigators second aim was to compare recurrent dyspeptic pain within 24 hours~          after discharge and cost of treatments in the treatment of dyspepsia.~   "
65719|NCT02197130|"~     This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920~     5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of~     subjects with Huntington's Disease. A total of approximately 260 subjects are planned to be~     randomized in the study. Primary endpoint is the change from baseline in the Total Motor~     Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks~     of treatment. secondary endpoints will include change from baseline in the Total Maximum~     Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global~     Impression-Improvement score after 13 and 26 weeks of treatment.~   "
65905|NCT02194673|"~     Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia~     and insulinemic responses compare to a trans free palm margarine (TFPM).~   "
65720|NCT02197117|"~     New treatments are required to improve health outcomes in patients with ischemic heart~     disease. This is especially so in developing countries such as Mauritius in which optimal~     therapy for acute myocardial infarction may not be widely available. For example for~     patients presenting with a heart attack (caused by a blockage in one of the heart blood~     vessels) the treatment of choice would be to remove the blockage by primary percutaneous~     coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like~     structure) to keep the artery opened. However, PCI is not widely available in Mauritius and~     heart attack patients are given clot-busting therapy to remove the blockage, but this is not~     as effective as PCI.~      Therefore, in this research study we investigate a new cheap treatment that may help protect~     the heart against damage during a heart attack, called remote ischemic conditioning (RIC),~     in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and~     deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting~     with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood~     pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage~     occurring during the heart attack and thereby prevent the onset of heart failure.~      Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring~     to the heart muscle during a heart attack..~   "
65721|NCT02197104|"~     The objective of this study is to determine if citocoline is effective for balance~     abnormalities and to stabilize cognitive decline in patients with fragile X-associated~     tremor ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months~     in an open label pilot study, with study visits at baseline, 3, 6, and 12 months.~   "
65722|NCT02197091|"~     This pilot research trial studies communication effectiveness in cancer treatment. Studying~     how well patients and their doctors communicate about the treatment being given for cancer~     may help improve the decisions that patients and physicians make together.~   "
65723|NCT02197078|"~     This protocol is for a series of comparative effectiveness and safety analyses within~     periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and~     other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety~     of health outcomes. The primary analysis will be conducted among patients without prior~     within-class medication use.~   "
65724|NCT02197065|"~     Up to 35% of hip fracture patients have been shown to experience heart injury after surgery,~     and as many as 10% have a heart attack or die in the three months after surgery. Hip and~     knee arthroplasty patients are also at risk of cardiovascular complications. Patients who~     have these complications have higher levels of inflammation postoperatively. Statins (such~     as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these~     effects are important in preventing heart attacks. Statins have been shown to reduce the~     risk of heart attacks in non-surgical patients, and to protect from heart attacks in~     patients having heart surgery. Whether statins can prevent heart attacks in orthopedic~     patients is not known.~      In this pilot study the investigators will treat 30 orthopedic surgery patients (hip~     fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no~     study drug). Patients will start the study drug prior to surgery and take it for 45 days~     after surgery. Neither the doctors nor the patients will know whether they are taking~     atorvastatin or placebo. The investigators will look for evidence of inflammation and heart~     injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree~     of postoperative inflammation found in these patients. In this study, the investigators will~     use a very sensitive test of heart injury that can detect problems even when patients have~     no symptoms. The investigators hypothesize that this test will demonstrate silent heart~     injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our~     study.~      The results of this trial will help us to develop a larger study in 1000 hip fracture and~     joint replacement patients to determine whether atorvastatin protects orthopedic surgery~     patients from heart injury and other complications of surgery.~   "
65725|NCT02197052|"~     The goal is to better understand the social needs of a population seeking care in a large,~     urban children's hospital emergency department with a large Medicaid population. Consenting~     English and Spanish-speaking adult caregivers will be randomized to social screening via a~     face -to-face interview with a trained bilingual researcher or via a self-completed~     tablet-based survey. We hypothesize that there will be no difference in disclosure rates~     between the two screening formats for items other than highly sensitive items. For highly~     sensitive items we hypothesize disclosure rates will be higher for the self-completed~     tablet-based survey.~   "
65726|NCT02197039|"~     The purpose of this prospective study is to identify risk factors which could predict poor~     fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful~     endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection~     criteria for patients who are indicated to receive second-look endoscopy.~   "
65727|NCT02197026|"~     Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc®~     versus usual treatments as well as evaluation of safety and effectiveness of these~     treatments.~   "
65728|NCT02197013|"~     Incidence and time of occurrence of blood leakage with the closed intravascular catheter~     Introcan Safety 3 in comparison to Introcan Safety~   "
65729|NCT02197000|"~     The purpose of this study is to determine whether adding DIM supplement will decrease breast~     density among female BRCA mutation carriers in two years.~   "
65730|NCT02196987|"~     Currently, there are no specific guidelines or best practice suggestions for best male~     catheterization as fat as insertion technique. There is however, information as to reducing~     infection, and as to recommended lubricant.~      From our experience, the investigators have noticed that when requesting the patient to~     attempt urination while inserting a urethral catheter, the level of pain and discomfort is~     reduced. In this study, the investigators will evaluate the pain level during male urethral~     catheterization in each technique.~      Our hypothesis is that the level of pain will be much less if the in the study group where~     the act of urination will be requested from the patient.~   "
65731|NCT02196974|"~     In patients with peripheral lung nodules, what is the additional diagnostic yield of~     biopsies obtained with flexible cryoprobes compared to standard techniques? For patients~     with peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of~     tissue to be obtained and therefore, will increase the diagnostic yield over conventional~     techniques~   "
65785|NCT02196272|"~     A number of strategies have been evaluated to improve clinical outcomes in diabetics~     patients, however no studies explored the efficacy of a nurse-led reminder program through~     email (NRP-e) to improve medication adherence, even if it is fundamental in the management~     of diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led~     reminder program through email (NRP-e) to improve medication adherence in diabetic patients.~   "
65938|NCT02194244|"~     This study will compare the pharmacokinetic performance of film-coated tablet and granule~     formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,~     four-period, four-treatment crossover design is used. In each period, each volunteer will~     receive a single oral dose of the tablet or granule formulation either with or without food.~   "
65732|NCT02196961|"~     Primary Objective:~      To estimate the efficacy of adjuvant ipilimumab therapy in completely resected Merkel cell~     carcinoma (MCC) patients; i.e. the primary endpoint is disease-free survival (DFS) rate at~     12 months, defined as the number of patients alive and free of disease at 12 months after~     randomization divided by the total number of patients randomized.~      Secondary Objectives:~      To assess safety and additional efficacy parameters of the ipilimumab treatment in MCC, as~     well as to characterize potential biomarkers; secondary endpoints are: (i) adverse events~     according to CTCAE (Common Terminology Criteria for Adverse Events), Version 4.0 criteria,~     that are definitely, probably, or possibly related to the administration of ipilimumab, (ii)~     Overall survival rate at 12 months, defined as the number of patients surviving at 12 months~     after randomization divided by the total number of patients randomized.~   "
65733|NCT02196948|"~     Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that~     eccentric exercise protocols can be effective for this condition. The inclusion of other~     therapeutic modalities could help to the management of these patients. A new therapeutic~     approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.~     The objective of this randomized clinical trial is to determine the effectiveness of the~     inclusion of EPTE into a eccentric exercise protocol for the management of patients with~     unilateral supraspinatus tendinopathy~   "
65734|NCT02196935|"~     Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly~     being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology~     patients at the Los Angeles County Hospital presents a unique and diverse patient~     population.~      Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct~     stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI~     cancer diagnosis and management, and the management of pancreaticobiliary problems in the~     underserved.~      All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be~     enrolled in the databaseThe timing, clinical presentation, and objective details of patient~     presentation are recorded prospectively. Additionally the results of the subsequent ERCP and~     EUS procedures. Subsequent, clinical course and pathology will also be recorded.~   "
65735|NCT02196922|"~     In the US, racial and ethnic disparities persist, even when income, health insurance and~     care access are addressed. For example, there is a greater prevalence of chronic heart~     failure (CHF), higher rates of hospital use and higher death rates in blacks as compared to~     whites. This is due to many factors including: reduced healthcare access, higher prevalence~     of hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and~     obesity. Given the magnitude of this chronic health issue, the growth of the elderly~     population, and increases in ethnic diversity, providers need to develop new ways of caring~     for those with chronic conditions living in health disparity communities.~      The investigators propose to implement a randomized study with health disparity~     community-dwelling patients. A bilingual clinician will follow patients for 3 months after~     hospitalization for CHF to test this approach for the proposed health disparity population.~     The investigators will obtain patient/caregiver input at multiple points during the research~     to make necessary adjustments to the intervention to ensure that disparity patients~     accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance~     for patients, a Community Advisory Board (CAB) of stakeholders will advise the study team~     throughout the study process. The investigators believe that studying patient use of TSM~     over a 3 month period will: 1) identify cost-effective care approaches for patients living~     with chronic disease; 2) involve the patient in identifying and testing approaches that work~     for them; 3) enhance provider-patient communication; 4) teach the patient how to~     self-monitor and explore his/her role in self-care; 5) improve patient education about~     treatment options and 6) explore how usable the patients feel the program is. If our goals~     are achieved, these strategies will result in patient-led improvements in health,~     satisfaction and quality of life. Knowledge gained will further understanding of the use of~     telehealth programs as effective self-management tools.~   "
65736|NCT02196909|"~     The objective of the study is to identify the best clinical and biological outcome measures~     for further therapeutics approaches.~   "
65737|NCT02196896|"~     The purpose of this study is to determine the acceptance and efficacy of the online~     self-help program deprexis® for depressed patients in reducing the clinical symptoms of~     their depression. The patients of the experimental group use deprexis® for 90 days, the~     patients of the placebo group receive weekly online information about depression for 90 days~     as well. Both groups receive their treatment in addition to their regular inpatient~     psychosomatic treatment and as an aftercare intervention.The investigators hypothesize that~     the online self-help group achieves a greater reduction of depression compared to the~     control group.~   "
65738|NCT02196883|"~     Patients are being asked to participate in a research study because the patients are being~     treated for low back pain and the patients have decided to have an epidural steroid~     injection.~      Low back pain has a tremendous impact on the individual and society. It not only affects the~     individuals quality of life, it also contributes to lost productivity and increased health~     care costs.~      Epidural steroid injections (ESIs) are a common treatment option for many forms of low back~     pain. They have been used for low back problems since 1952 and are still being used as a~     non-surgical form of treatment for low back pain. The goal of the injections is reduction of~     pain, increased quality of life and improved function.~      This study is being conducted to determine the outcomes of injections given at the level of~     MRI Pathology versus at the level of clinical symptoms to see if one is more effective~     than the other and to learn more about the characteristics of the two different injections.~   "
65739|NCT02196870|"~     Patients with chest wall elastance increasing could worsen lung function. Increasing of~     chest wall elastance plays a great role in lung mechanics, and could influence mechanical~     ventilation settings. Therefore, It could help the physicians to find appropriate indicators~     and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics~     changse in the patients with high chest wall elastance.~   "
65740|NCT02196857|"~     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help~     to control the disease in patients with AML and high risk MDS with FLT3-ITD mutation. The~     safety of this drug combination will also be studied.~   "
65741|NCT02196844|"~     The goal of this behavioral research study is to learn the opinion of patients and their~     caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer.~     Researchers also want to learn the effect of this program on lung function, distress,~     biological function, and quality of life. For comparison purposes, there will also be a~     group of participants (Group 2) that does not take part in this program.~      You and your caregiver/family member will have about a 50/50 chance of being assigned to~     each group. The groups are randomly assigned, but it is also based on other factors such as~     your age and the status of the disease.~   "
65939|NCT02194231|"~     The purpose of this study is to determine whether trabectedin is effective in the treatment~     of malignant pleural mesothelioma (MPM).~   "
65742|NCT02196831|"~     Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV)~     infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40%~     of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of~     NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and~     fibrosis.~      NAFLD is most prevalent in patients who also have increased visceral adiposity, and our~     group has previously shown that HIV-infected individuals with increased visceral adiposity~     generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing~     hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is~     FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous~     study, treatment with tesamorelin in HIV-infected individuals selected for abdominal~     adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin~     on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The~     investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate~     the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.~   "
65743|NCT02196818|"~     This is a multi-centre, prospective post marketing surveillance study to assess mid-term~     performance of the Mpact cup in subjects requiring primary total hip arthroplasty.~   "
65744|NCT02196805|"~     This study compares the pharmacokinetics characteristics of a single oral intake of an~     imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang~     Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.~   "
65745|NCT02196792|"~     The aim of this study is to investigate the wear of two different polyethylene liners~     (E-Poly and ArcomXL, Biomet inc.) of primary total hip arthroplasty. This study is divided~     into one main study and three sub-studies.~        -  The main study investigates the wear of the liner using radiostereometric analysis~          (RSA) with five years follow-up. A two year follow-up analysis will be reported.~        -  Other studies i) investigate the cup migration in respect to the pelvis between two~          different femoral head sizes (32- and 36-mm), ii) clinical outcome score (Harris Hip~          Score, SF-36, UCLA, EQ5D) will also be evaluated.~      An explorative study will be conducted investigating the possibility of using a bi-plane~     technique as RSA to detect the rigid body segment of the hip with a reduction of roentgen~     dose.~   "
65746|NCT02196779|"~     Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of~     complications is reduced by limiting the operative dissection. However, this can compromise~     the quality of the result. This study was undertaken to investigate the blood supply of the~     abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is~     injected and the fluorescence is recorded using a near-infrared laser. The blood supply is~     tested after a limited dissection and then after a traditional dissection to determine~     whether an extended dissection reduces the skin circulation. The study hypothesis is that~     there is no difference in blood supply and the traditional abdominoplasty does not~     compromise skin circulation.~   "
65747|NCT02196766|"~     To determine if patients are unreactive to the lens care solution / Biofinity combination.~   "
65748|NCT02196753|"~     The aim of this single-center randomized controlled trial is to assess clinical usefulness~     of positron emission tomography combined with computed tomography (PET CT) in the diagnostic~     process of suspected cardiovascular implantable electronic device (CIED) infection (lead~     dependent infective endocarditis, generator pocket infection, fever of unknown origin).~   "
65749|NCT02196740|"~     The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root~     canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in~     the treatment of periapical periodontitis of deciduous teeth is superior to other drugs~     currently in use as creosote.~   "
65750|NCT02196727|"~     The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation~     receiving multimodal analgesia in day-case surgery setting.~      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom~     Cleft Lift operation.~   "
65751|NCT02196714|"~     A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,~     Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the~     Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.~   "
65752|NCT02196701|"~     The purpose of this study is to determine the safety and efficacy of the use of the~     combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in~     suboptimal responders to ADA monotherapy.~   "
65753|NCT02196688|"~     Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and~     one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor~     activity in patients with advanced CRC in phIb study.~      This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of~     patients with metastatic CRC who have progressed after metastatic CRC second line or above~     standard chemotherapy.~   "
65754|NCT02196675|"~     Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung~     cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm~     and/or 60 mm (study devices) in a Korean population.~   "
65755|NCT02196662|"~     The primary objective of this study is to compare the rate and extent of absorption of~     mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus~     Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single~     oral dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or~     1 x 400 mg delayed-release capsule under fasting conditions.~   "
65756|NCT02196649|"~     Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal~     Resection (EMR) site following complete removal of the lesion, or will not receive clips and~     proceed with standard of care.~   "
65757|NCT02196636|"~     This two-part study will assess the safety and tolerability of single ascending oral doses~     of RO6806127 in a group of healthy male participants and investigate the effect of high fat~     and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in~     a separate group of healthy male participants. The relationship between drug exposure and~     tolerability will be explored.~   "
65796|NCT02196129|"~     The purpose of this study is to investigate the immediate pain relieving effects of~     sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care~   "
65758|NCT02196623|"~     Ageing is the primary risk factor for most chronic diseases including type 2 diabetes~     mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial~     mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus,~     metabolic disease and frailty, which limits physical mobility as well as quality of life,~     share common cellular mechanisms.~      The investigators will test the hypothesis that a combination of normobaric hypoxia and~     exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle~     dysfunction and the investigators will address the molecular mechanisms. In a randomized~     clinical study, the investigators will compare normoxic and hypoxic training conditions in~     elderly subjects. Outcome measures will focus on whole body insulin sensitivity and~     mitochondrial responses in skeletal muscle before and after the 8-week training~     intervention.~   "
65759|NCT02196610|"~     People with kidney failure have a higher chance of getting disease in the blood vessels and~     this result in a decreased elasticity of the arteries of their body which make them very~     stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the~     risk of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a~     method called applanation tonometry, which measures the pulse wave velocity of major~     blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is~     to determine if we can measure arterial stiffness reliably and accurately using this method~     in healthy people and in people with kidney failure receiving hemodialysis treatments at our~     centre. Also, we would like to know how stiff these arteries in healthy people are. If we~     demonstrate that the method is reliable and accurate in these 2 groups of participants at~     our centre, a future larger study is planned to determine if we can use measures of arterial~     stiffness to evaluate the risk of stroke and heart disease in people with kidney failure~     receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside~     Campus.~   "
65760|NCT02196597|"~     Background: High prevalence of fecal incontinence after rectal resection in patients with~     rectal carcinoma.~      Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict~     fecal incontinence.~      Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal~     endosonography before and 1 month after closure. Prediction of postoperative incontinence by~     the surgeon (digital sphincter examination). Visual analog scales for continence, subjective~     success of operation, and global well being; Wexner and Vaizey incontinence score; Parks~     incontinence classification; Rockwood fecal incontinence quality of life score; each before,~     1 and 6 month after closure.~   "
65761|NCT02196584|"~     Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid~     speculum during intravitreal injections~      Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with~     those of the conventional lid speculum and caliper approach~   "
65762|NCT02196571|"~     Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various~     degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize~     glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is~     recommended to continue or initiate exercising with moderate intensity. However, available~     data on the effects of physical activity on GDM are based on a small number of trials. The~     aim of the trial is to examine and add new scientific evidence on possible health-related~     effects of application of structured programme consisting of aerobic and resistance~     exercises on the course and outcomes of GDM. Primary goal of research is to determine how~     proposed exercise programme effects glycaemic control, rate of complications during~     pregnancy, labour, delivery, immediate after delivery and health status of newborn. Main~     hypothesis is that parameters of glycaemic control, course of GDM, complications during~     delivery and birth outcomes directly and significantly correlate with participation in~     structured programme of exercise. Research will be conducted as experimentally designed~     randomized controlled trial. Participants will be pregnant women diagnosed with GDM, age~     between 20 and 40, without comorbidities. Women in the experimental group will be included~     in exercise programme two times per week with duration of 50 minutes. Training sessions will~     start right after the diagnosis and will be performed until the end of the pregnancy. The~     training protocol will follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008;~     NICE, 2008; ADA 2011). Women in the control group will receive standard medical care.~   "
65763|NCT02196558|"~     This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study~     is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate~     mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011~     in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg~     group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400~     mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011.~     Subjects who roll over onto the Extension phase will have continued monitoring until 52~     weeks after the initial administration.~   "
65764|NCT02196545|"~     The purpose of this study is to determine if a home based physical activity training program~     for patients with Alzheimer's dementia has effects on clinical and neurobiological~     parameters.~   "
65765|NCT02196532|"~     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can~     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber~     layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected~     in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's~     disease. Different studies have reported RNFL changes also in migraine, is a common~     hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic~     nervous system. The pathophysiology of migraine has not been fully clarified, but there is~     increasing evidence that episodes of migraine with aura are initiated by a focal reduction~     in cerebral blood flow, which occurs most commonly in the posterior region of one~     hemisphere. Although vasoconstriction of cerebral and retinal blood vessels is a transient~     phenomenon, the chronic nature of the migraine might cause permanent structural~     abnormalities of the brain and also of the retina, which may correlate with RNFL thinning.~     Previous studies on this subject, however, reported contradicting results. Some~     investigations reported reductions of the RNFL thickness while others did not. In the~     present study, in order to determine whether RNFL thickness is reduced in migraine patients,~     the investigators performed a meta-analysis and systematically evaluated RNFL thickness~     measurements with OCT in a series of migraine patients and in the healthy control groups.~   "
65768|NCT02196493|"~     We have noticed a group of patients presenting with a longstanding wet cough which has often~     been treated as asthma. The cough is productive of sputum which frequently contains~     bacteria, but does not resolve with standard antibiotic treatment.~      A very similar cough is seen in subjects who smoke, have exposure to airbourne dusts or~     chemicals or have a condition known as bronchiectasis, but these problems have already been~     excluded.~      We have found that prolonged treatment with an antibiotic called azithromycin is very~     effective but using azithromycin in this way is not licensed and there is currently no trial~     evidence to support its use.~      This research will evaluate the clinical benefit of low dose azithromycin to determine if~     this is an effective and safe treatment for these patients. It will also involve a detailed~     investigation of these patients to determine whether they have enough in common to believe~     we are describing a new condition.~   "
65769|NCT02196480|"~     Objectives: To assess immunogenicity and safety of the 23-valent polysaccharide pneumococcal~     vaccine (PPV23) in JIA patients with and without anti-TNF therapy. The influences of~     demographic data, disease activity and treatment on immune response and the potential~     deleterious effect of vaccine on disease itself were also evaluated.~      Methods: 17 JIA patients immediately pre-etanercept (Group 1) and 10 JIA patients on stable~     dose of methotrexate (Group 2) will receive one dose of PPV23. All patients will be~     evaluated pre-vaccination, 2 months and 12 months post-vaccination for seven pneumoccocal~     serotypes. Serology will be performed by enzyme immunoassay and the immunogenicity endpoints~     will include seroprotection (SP), seroconversion (SP) and geometric mean concentration of~     antibodies (GMC). Clinical and laboratorial parameters of JIA will be evaluated before and~     after vaccination.~   "
65770|NCT02196467|"~     This Phase I/II of the clinical trial is to investigate whether the transplantation of~     normal myoblasts throughout one muscle (the extensor carpi radialis) of the patients is safe~     and will improve the strength of that muscle. During this Phase I/II, the patients will be~     transplanted with myoblasts grown from the muscle biopsy of a donor and kept frozen in~     liquid nitrogen. Thirty million myoblasts will be injected per cm cube in a progressively~     higher surface of the radialis (i.e., 3, 6 and 9 cm2). The contralateral muscle will be~     injected with saline to serve as a control. The strength of both muscles will be measured at~     3 months post transplantation to verify whether the myoblast transplantation improved the~     strength of the muscle. If there is no significant strength improvement, the protocol will~     be terminated immediately for that patient. If there is a significant strength improvement,~     the patient will be maintained under immunosuppression until 6 months post transplant and~     his strength will be re-evaluated.~   "
65771|NCT02196454|"~     The purpose of this research study is to determine if video-based education will increase~     HPV vaccination rates among 11 - 17 year olds.~   "
65772|NCT02196441|"~     General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery~     (Phakic IOL) , the short duration of the surgery, general anaesthesia complications,~     decrease the length of hospital stay and decreasing the costs direct the interest to the~     regional anaesthesia By the time the traditional retro and peribulbar injections recede to a~     newer techniques that is safer and cheaper, sub tenon's block using a blunt needle took over~     due to the more safety profile Even though, still serious problems can occur specially in~     patients with long axial length.~      Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took~     over with promising and successful results, decreasing length of hospital stay and~     increasing patient satisfaction and fewer margins of complications.~      In this study the investigators compared topical anaesthesia alone with DTFNBA in patients~     undergoing posterior chamber phakic IOL surgery (Visian ICL).~   "
65773|NCT02196428|"~     The aim of this study is to explore the requirements and conditions of medical~     teleconsultation and remote diagnostics (telemonitoring) of older people in the residential~     environment with an emphasis on the need for adaptation, feasibility and acceptance of~     telemedicine services to a web based documentation and communication platform (Ambient~     Assisted Living Wizard).~   "
65774|NCT02196415|"~     -  The measurement of hindfoot alignment is a technical challenge.~        -  Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs~          or long axial view radiographs. Measurements on both types of radiographs are hampered~          by technical shortcomings such as minimal rotational misplacement of the foot at the~          time of image acquisition. In previous publications our study groups demonstrated~          substantial measurement errors due to these shortcomings as well as bad interreader~          agreement.~        -  Hindfoot alignment measurement is feasible on MR images but hampered by the~          non-weight-bearing position of the patient and therefore not suited for pre-treatment~          evaluation.~        -  In an ex vivo study using plastic phantoms of a foot our research group could~          demonstrate superior interreader agreement and complete correction for foot~          misplacement at the time of image acquisition using a 3D secondary measurement~          technique based on biplanar low dose radiographs.~        -  Image acquisition using biplanar low dose radiographs is associated with a substantial~          reduction (about 1/7) of radiation dose applied to the patient compared to standard~          radiographs.~        -  Therefore the question arises if these excellent ex vivo results can be confirmed in a~          prospective clinical study.~      Objectives:~        1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on~          biplanar radiographs.~        2. Reproduction of superior interreader agreement of measurements based on biplanar~          radiographs compared to measurements on conventional radiographs.~   "
65797|NCT02196116|"~     This research aim to explore relationships between the presence of amyloid burden and~     cognitive performance, and its modulation by educational level. For this purpose we will~     combine Positron emission tomography (PET) imaging and neuropsychological assessment~     acquired on 3 groups of subjects, from two population-based cohorts 3C and AMIMage The~     first group includes cognitively intact participants who will serve as controls, the second~     group, subjects with mild cognitive impairments without memory complaint and the third,~     subjects with both mild cognitive impairments and memory complaint.~   "
65798|NCT02196103|"~     Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity~     of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has~     led us to undertake the present clinical trial.~   "
75086|NCT02074514|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir~     (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C~     virus (HCV) infection.~   "
65775|NCT02196402|"~     Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow~     band imaging (NBI), might allow the determination of polyp management and surveillance~     interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced~     histological features are uncommon and the prevalence of invasive cancer is negligible (1).~     On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an~     initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical~     practice (1), which states that:~        1. for diminutive polyps to be resected and discarded without pathologic assessment,~          endoscopic technology (when used with high confidence) used to determine histology of~          polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm~          in size, should provide a > 90% agreement in assignment of post-polypectomy~          surveillance intervals when compared to decisions based on pathology assessment of all~          identified polyps.~        2. In order for a technology to be used to guide the decision to leave suspected~          rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the~          technology should provide > 90% negative predictive value (when used with high~          confidence) for adenomatous histology~      This strategy could potentially exert a significant impact on colonoscopy practice, by~     decreasing at some extent pathology-associated costs, although those related to histological~     analysis of >5mm polyps is maintained.~      In a recent study performed in our Centre (2), we restricted the application of the resect~     and discard strategy to patients with small or diminutive polyps only, achieving an~     accordance between endoscopy-directed and histology-directed surveillance strategy of about~     85% in both populations. This approach, where decisions on patient management are driven~     only by the in vivo endoscopic assessment, provides on one hand a slightly lower~     accordance than the threshold of 90% set by the PIVI, but on the other one it allows the~     complete spare of pathology related costs, although for a smaller proportion of patients.~     Moreover we observed a negative predictive value of 86% for the presence of adenoma within~     the diminutive polyps cohort, although a separate analysis for left sided ones was not~     performed.~      AIms of this single center, prospective, observational study:~        1. To prospectively evaluate the accordance between the endoscopy-directed and~          histology-directed surveillance strategies by applying the resect and discard strategy~          for diminutive polyps according to the PIVI statements~        2. To assess the economic impact of the resect and discard strategy when applied either~          according to the PIVI statements or to restrictedly to subjects with diminutive polyps~          only~        3. To provide a temporary validation of diagnostic performances of the resect and discard~          strategy for our group and the potential presence of a learning effect for the~          methodology~        4. Accordance between endoscopists' and nurses' categorization of adenomas according to~          standardized criteria (see below)~   "
65776|NCT02196389|"~     Several nasal dilators are currently commercially available, and can be applied endonasally~     (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison~     between these dilators has not been made so far, and would help the clinicians to advise the~     use of any of these dilators. From clinical experience, endonasal dilators are well~     supported and improve breathing better than the external dilators~   "
65777|NCT02196376|"~     In this pilot study, the investigators will test the hypothesis that patients with postural~     tachycardia syndrome will have an elevated percentage of functional antibodies to adrenergic~     receptors compared with control subjects without POTS. The investigators further hypothesize~     that the percentage of POTS patients with antibodies will be higher in those patients with a~     viral infection at the onset of their illness than in those patients with other or undefined~     illness onsets.~   "
65778|NCT02196363|"~     Babies that are either very small or very big have increased perinatal morbidity and~     mortality. Predicting which babies will fall into these groups is traditionally done with~     risk assessment and third trimester manual palpation, however neither of these techniques~     are sensitive and a considerable number of affected pregnancies are missed. This results in~     stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third~     trimester can improve detection rates but this is expensive and cannot currently be provided~     to all NHS patients.~      A more sensitive test that can be performed earlier in pregnancy would allow identification~     of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound~     techniques that measure volume and volumetric flow have become available that may allow this~     to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant~     women. The findings from these scans will then be correlated with actual birth weights at~     the end of pregnancy to determine the ability of these parameters to act as screening tools~     for babies at the extremes of size.~   "
65779|NCT02196350|"~     The study aims to assess the impact of the P4 approach on established markers of glucose~     metabolism in type 2 diabetics.~      Secondary objectives are examination of the changes in physical characteristics, quality of~     life and the indices for beta cell function, hepatic insulin resistance and muscle insulin~     resistance .~   "
65780|NCT02196337|"~     The purpose of this study is to determine whether universal salt iodization (USI) meets the~     iodine requirements of pregnant women, lactating women and infants.~   "
65781|NCT02196324|"~     The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor~     antagonist is safe and effective for treatment of prurigo nodularis versus placebo.~   "
65782|NCT02196311|"~     Patients treated with circular external fixation will have better outcomes (as measured by~     range of motion (ROM), alignment, outcome surveys) than those treated with open reduction~     and internal fixation (ORIF).~   "
65783|NCT02196298|"~     The Lokomat is a robotic treadmill gait trainer that is used to help people who have~     neurologic conditions walk better. Early research with children with cerebral palsy (CP)~     shows that it may help to improve walking skills. The purpose of this two-group randomized~     study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on~     walking abilities and related function. The primary (alternate) hypothesis is that children~     will improve more with Lokomat training in terms of gross motor skills and walking~     endurance.~      The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP~     and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20).~     In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is~     done first is decided by an independent randomization process that occurs after the first~     baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly~     therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for~     set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum~     of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and~     balance activities. There is a 6 week break between the Lokomat and PT interventions.~      Each child has four study assessments during their ~6 months in the study. The first~     assessment is done before starting the Lokomat or physiotherapy phase. The second happens~     after the first intervention has finished. The child then has a 6-week break period. The~     third assessment is done at the end of this break, and the fourth occurs after the second~     intervention. The PT assessor who does these assessments will not be the same as the PT who~     gives the intervention. The assessor is blinded to the child's intervention phase and~     previous assessment results. The primary outcome measures are the Gross Motor Function~     Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities,~     participation, health related quality of life and individualized goals.~      The randomized aspect of the study lets us look at outcome differences between children for~     Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase~     evaluates within-child outcomes across the two phases. A qualitative component is~     concurrently underway to examine child/parent experiences and their views of Lokomat~     outcomes.~   "
65784|NCT02196285|"~     Measles and rubella are highly contagious acute viral diseases. As per WHO, several~     evidences demonstrate the benefit for providing the universal access to vaccines containing~     measles and rubella antigens, mainly due to, respectively, mortality in children and~     malformations in fetuses. This is a Phase I, open study, non-controlled, to evaluate the~     safety, tolerability and imunogenicity of double viral vaccine anti-measles and rubella~     (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos~     Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 30 eligible volunteers, between~     18-49 years old, will be vaccinated and monitored for local and systemic adverse events and~     titration of antibodies. The study will last 20 months in total.~   "
65786|NCT02196259|"~     Functional connectivity is defined as a correlation in neural activity between distinct~     regions of the brain. Several recent studies have demonstrated areas of low-frequency~     functional connectivity inherent to brain tissue at rest. These oscillations can be measured~     using functional magnetic resonance imaging (fMRI) and appear to be synchronized between~     related areas of the brain.~      To date, no investigators have examined the effects of low-dose anesthesia on functional~     connectivity. This study will image the human brain under conditions of rest, and low-dose~     anesthetic induced sedation. Quality of the acquired signals will be evaluated and~     functional networks in the brain will be examined. Of interest is whether administration of~     a low-dose anesthetic disrupts functional connectivity in the brain, and whether a~     disruption of functional connectivity is responsible for the reported analgesic and~     antidepressant effects of a anesthetic.~      Participation in the study includes four visits: an in-person interview, an initial fMRI~     scan, the anesthesia infusion, and a second fMRI scan. There is an optional follow-up fMRI~     scan one week post infusion.~   "
65787|NCT02196246|"~     To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination~     of benign from malignant suspicious skin lesions or moles. Specifically the objective is to~     demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to~     identify lesions which are benign~   "
65788|NCT02196233|"~     Trigger finger is a condition commonly treated with surgical intervention, yet no specific~     incision type has been associated with improved or worsened scar quality or outcome.~     Therefore, the investigators objective is to determine if the incision type may affect the~     results of operative treatment of trigger finger. Therefore, the goals of this study are as~     follows:~      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for~     trigger finger release with scar quality and patient satisfaction via a validated scar~     evaluation scale.~      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for~     trigger finger release to patient outcome via a validated upper extremity outcome score.~   "
65789|NCT02196220|"~     Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo~     syndromes. These patients have a genetic enzyme deficiency that results in the inability to~     degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell~     enlargement and subsequent dysfunction. The accumulation occurs in all tissues including~     cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger~     digits, and various other orthopaedic manifestations [Van Heest, White]. These children~     often suffer from severe cognitive impairment and are often unable to communicate pain or~     numbness. Carpal tunnel syndrome is almost always present, but may not become apparent until~     symptoms are severe and loss of function has occurred. The current gold standard for~     diagnosis consists of electromyographic (EMG) and nerve conduction velocity (NCV) studies~     under sedation or general anesthetic [Khanna].~      Primary Objective: The investigators plan to correlate EMG findings and median nerve~     cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is~     that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove~     to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding~     the need for EMG studies and anesthesia.~      Secondary Objective: The investigators want to determine the cross-sectional area of the~     median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The~     investigators plan to evaluate a cohort of healthy children to determine a normal~     cross-sectional area of the median nerve.~   "
65790|NCT02196207|"~     This study will evaluate if inhibitors are reduced when Eloctate is begun in children with~     severe Hemophilia A before the first bleed (preemptive) and continued weekly to prevent~     bleeds (prophylaxis).~   "
65791|NCT02196194|"~     This prescription-event monitoring study was based upon 'event' monitoring and so capable of~     identifying signals of events that might be associated with the use of tiotropium, which~     none of the participating general practitioners (GPs) suspected to be an adverse drug~     reaction. The methodology of this study readily permits follow up of specific events and the~     obtaining of additional data as appropriate.~   "
65792|NCT02196181|"~     This randomized phase II trial studies how well dabrafenib and trametinib work in treating~     patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf~     proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
65793|NCT02196168|"~     This randomized phase II trial studies how well cisplatin with or without WEE1 inhibitor~     MK-1775 works in treating patients with head and neck cancer that has come back or has~     spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin, may~     prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA), which in~     turn stops the tumor from growing. WEE1 inhibitor MK-1775 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether~     cisplatin is more effective with or without WEE1 inhibitor MK-1775 in treating patients with~     head and neck cancer.~   "
65794|NCT02196155|"~     Plantar fasciitis is the classic and most common type of heel pain. Considering the costs~     for health care and the temporary disability not only for work, plantar fasciitis results in~     a substantial (and at least partially unnecessary) burden for the Swiss health care system~     and national economics.~      Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no~     treatment has proven to be superior to others, and there is national and international lack~     of consensus of how to treat plantar fasciitis best.~      The investigators believe that the BTX-A injection in the gastrocnemius and the soleus~     muscles is currently the most promising non-operative approach, because it is considered to~     treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as~     opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections,~     ESWT).~      However, to date there is no evidence in the literature that compares the new, promising~     technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection~     and to the gold standard steroid injection at the plantar fascia insertion site. With the~     intended study, this gap is going to be closed.~   "
65795|NCT02196142|"~     To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol~     addicted subjects.~      Randomized, double-blind, placebo-controlled, cross-over, single administration of study~     medication.~      Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity~     in alcohol dependent subjects.~   "
65799|NCT02196090|"~     Obsessive Compulsive Disorder (OCD) is a condition associated with recurrent intrusive~     distressing thoughts, images and urges compelling the person to perform neutralizing acts or~     thoughts to the extent of significantly interfering with their daily activities. The~     symptoms of OCD are associated with both subjective and objective signs of distress.~     Treatment for Obsessive Compulsive Disorder is often associated with significant subjective~     distress with high dropout rates and often only limited improvement. Attempts to reduce~     distress in anxiety often focus on re-establishing the sympathovagal balance by enhancing~     the vagal or parasympathetic tone and it has been suggested that this can reduce the~     mobilization behaviours of fight or flight response and improve emotion regulation. This~     study will investigate the effect of a procedure potentially reducing distress and improving~     outcome of treatment in inpatients admitted for treatment for OCD to the Anxiety Disorders~     Residential Unit. The procedure will be based on increasing vagal tone by application of~     cold face mask on 3 consecutive days in addition to the standard Exposure and Response~     Prevention therapy (ERP).~   "
65800|NCT02196077|"~     This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five~     treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The~     overall objective is to demonstrate that the combination of budesonide (BD; PT008) and~     formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides~     benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.~   "
65801|NCT02196064|"~     To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin~     elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the~     combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a~     single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus~     (HCV)-coinfected subjects.~   "
65802|NCT02196051|"~     The purpose of this study is to examine the pathophysiology of insulin resistance and the~     relation to the metabolic syndrome in humans.~   "
65803|NCT02196038|"~     REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a~     multicenter, randomized, attention-controlled, single-blind trial designed to examine the~     hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain~     rehabilitation intervention administered to older patients with acute decompensated heart~     failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will~     improve physical function and key clinical outcomes, including the rate of~     rehospitalization.~   "
65804|NCT02196025|"~     Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that~     has been approved as a treatment of depression in patients that have not responded to a~     trial of one antidepressant medication. The investigators hypothesize that low frequency TMS~     exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia~     and therefore is therapeutic. The investigators want to compare the change in insomnia~     scores between baseline and end of treatment in an open label trial with bifrontal low~     frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3~     weeks (15 week days).~   "
65805|NCT02196012|"~     The purpose of this study is to determine the feasibility and acceptability and efficacy of~     a two month technology-based weight loss program for overweight and obese college students.~   "
65806|NCT02195999|"~     This study seeks to develop and validate non-invasive assessments of cardiac and respiratory~     muscles with magnetic resonance imaging (MRI) to better predict the natural disease~     progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well~     as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary~     dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle,~     and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.~   "
65807|NCT02195986|"~     The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol~     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol~     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7~     day treatment.~   "
65808|NCT02195973|"~     The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial~     effects when combined with paclitaxel in women with platinum resistant ovarian cancer.~     Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone~     chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).~   "
65809|NCT02195960|"~     Attention has been focused recently on the development of modalities that can protect~     healthy organs from the harmful effects of radiation applied during different cancer~     treatment schedules. As radiation-induced DNA damage involves oxidative stress, the~     protective role of antioxidants has been tested in different dietary studies. Previous~     experience by the collaborative team of the principal investigator and radiotherapists at~     the Catholic University of Campobasso has shown in a retrospective study that moderate wine~     consumption can reduce the side-effects of radiation therapy in patients with breast cancer.~     This effect was presumably due to the polyphenol non alcoholic fraction of wine, a finding~     in agreement with a cross-over intervention study in adult male volunteers, on protection by~     de-alcoholized red wine from ex vivo radiation-induced DNA damage.~      The purpose of this clinical trial will be to test the impact of supplementation with~     anthocyanin-enriched food on the acute and medium-term side effects of radiotherapy in~     breast cancer patients, in a prospective study design. Therefore a double blind, randomised,~     placebo-controlled clinical trial will be organised by assigning patients with breast cancer~     scheduled for radiotherapy to a diet supplemented with an anthocyanin soluble extract.~   "
65810|NCT02195947|"~     The effect of use of the growth hormone with antagonist protocol on the outcome of the~     IVF/ICSI cycles in poor responders.~   "
65823|NCT02195778|"~     Health Literacy is the ability to understand health information and to use that information~     to make good decisions about health and medical care. Health informatin can overwhelm even~     people with advanced literacy skills. About one third of the adult population in the United~     States has limited health literacy.~   "
65931|NCT02194335|"~     The objective of the present study was to obtain information about safety, tolerability and~     pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy~     male and female volunteers. With respect to pharmacokinetics, it was of particular~     importance to investigate whether therapeutic plasma levels (for treatment of migraine)~     could have been achieved by oral administration of a BIBN 4096 BS formulation.~   "
65811|NCT02195934|"~     This study aims to compare the effect of an anthocyanin-rich blood orange juice with a~     standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).~      Participants aged between 25 and 84 years of age will be recruited into a single arm, two~     way cross-over study based on their waist measurement, with 42 individuals required to~     complete the study. Participants will each receive two interventions in a randomised order:~     500mL blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily~     for 28 days.~      Prior to each intervention there will be a 2 week run in period where participants will be~     asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention~     period, there will be a 3 week wash out period after which the participants will be asked to~     then drink the other juice for 28 days. The 500 mL of blood orange juice contains~     approximately 50mg of anthocyanins, whereas the standard juice contains none.~      Blood samples will be collected for the preparation of plasma and peripheral blood~     mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,~     transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion~     of anthocyanin metabolites will be quantified. Other measurements will include pulse wave~     analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood~     glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements~     using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,~     fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral~     fat rating, and degree of obesity. All measurements and samples will be taken at baseline~     and post intervention for each phase of the study.~   "
65812|NCT02195921|"~     The purpose of this study is to clarify whether the matching acupoints is more effective~     than a single point by electroacupuncture in the management of chemotherapy-induced nausea~     and vomiting .~   "
65813|NCT02195908|"~     The purpose of this study is to clarify whether the matching acupoints are more effective~     than a single point by electro-acupuncture in the management of chemotherapy-induced nausea~     and vomiting .~   "
65814|NCT02195895|"~     The purpose of this study is to determine if a year of alendronate treatment will maintain~     or increase bone mass density (BMD) compared to baseline BMD values in people with chronic~     SCI.~      This study will also investigate 1) if alendronate therapy will increase bone strength in~     people with chronic SCI, 2) the safety of alendronate, and 3) the effects of alendronate on~     serum markers of bone metabolism.~   "
65815|NCT02195882|"~     The purpose of this study is to determine whether a specific strengthening program for the~     stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.~   "
65816|NCT02195869|"~     The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in~     subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.~   "
65817|NCT02195856|"~     Rationale:~      Mediterranean style diets and diets rich in green leafy vegetables protect against the risk~     of developing type 2 diabetes and a wide range of cardiovascular disease. These diets are~     rich in nitrate. Numerous studies have shown that nitrate from the diet can have a wide~     range of beneficial effects. These include relaxing blood vessels and improving their~     function. It has been shown that following a meal with added nitrate, blood flow to the~     stomach increases more than would be expected if the same meal is given without nitrate.~     This is because when we eat nitrate the body concentrates it and recycles it through the~     digestive system. As it cycles through it is converted into nitrite and nitric oxide which~     cause blood vessels to relax. The nitrite and nitric oxide also seem to protect against~     infection from food sources such as E.coli.~      What we do not know is whether this nitrite and nitric oxide has any effect on the small~     intestine and the liver. Some nitrite reaches the small intestine and may have the same~     effect on blood flow there as it does in the stomach. This could be very important because~     the small intestine releases hormones called incretins which we now know play a very~     important role in controlling blood sugar every time we eat. These incretin hormones~     regulate insulin release and the body's sensitivity to insulin. When we eat blood containing~     the substances we have absorbed from the gut, such as sugars and fats, goes to the liver for~     processing. The blood then leaves the liver and enters the circulation. This means the blood~     supply to the liver will have much higher concentrations of nitrite than the blood~     circulating in the rest of the body. High concentrations of nitrite appear to cause blood~     vessels to open up. This means more blood vessels in the liver should be opened after a~     nitrate rich meal. It seems likely that this will help the liver to control blood sugar more~     effectively.~      Purpose To find out if supplementation by inorganic nitrate as found in beetroot or green~     leafy vegetables increases liver (hepatic) microvascular perfusion and increases incretin~     secretion.~      Plan of investigations:~      We will recruit 16 individuals for each of the three groups (Young adults, older adults and~     individuals with type 2 diabetes). Participants will be recruited from a database of~     volunteers who have consented to being contacted for research studies which are held by the~     NIHR Exeter Clinical Research Facility. This is a double blind, placebo controlled crossover~     design study (nitrate rich beetroot juice vs a placebo, nitrate depleted beetroot juice).~     Three visits will be required for participants to complete this study.~      Visit 1. Screening and consent. The experimenter will explain to the participant what the~     study is designed to test. If the participant is completely clear on the study and~     understand what they are agreeing to, they will sign a consent form. In addition a standard~     medical history and clinical examination will be undertaken by a research nurse and or~     Anthony Shepherd. A venous blood sample will be taken using standard aseptic procedures.~     Following consent participants will be assigned a study number. Study numbers will be~     previously assigned (by a research statistician) to a randomisation order to begin either~     the beetroot juice or placebo arm of the study first.~      Visit 2. Visit 2 will require the participant to fast over night from 10pm. Only water will~     be admissible from this time. The following morning participants will arrive at the~     laboratory in a fully hydrated and rested state at ~ 7.30am. This visit will take ~ 5 hours~     and will require 4 MRI scans. Participants will have the first MRI scan after a short~     acclimatisation period. Participants will then be provided with a concentrated 140 mL~     nitrate drink or placebo with a standardised breakfast (2 slices of toast with butter).~     Three subsequent MRI scans will be required (one per hour for three hours). Venous blood~     samples taken from cannulas will be sampled, in order to assess glucose, insulin, incretins~     and nitrate/nitrite prior to each scan. Visit 3. Visit 3 will take place after a minimum~     washout period of 7 days from Visit 2. Visit 3 will be identical in nature to visit 2;~     however, it will be with the opposite supplement (either nitrate rich or placebo beetroot~     juice).~      Impact:~      Dietary nitrate appears to offer a simple, low cost means of modifying cardiovascular risk.~     This study will deepen our understanding of the role of the nitrate/nitrite/nitric oxide~     pathway in normal physiology. By understanding what effect inorganic nitrate from the diet~     has on hepatic perfusion and other pathways involved in glucose homeostasis this may lead to~     a range of simple, low cost therapeutic strategies to prevent and treat type 2 diabetes.~   "
65818|NCT02195843|"~     Heart failure is the most rapidly growing cardiovascular condition in developed countries.~     Despite advances in medical therapy, patients with heart failure are at high risk for death~     and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an~     effective treatment for heart failure.~      Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV~     lead cannot be implanted in patients undergoing a trans-venous system implantation. In this~     case, the patients may undergo multiple procedures before a lead is successfully implanted.~     These implant failures are not due to patient selection but rather to patients heart anatomy~     leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic~     stimulation) and poor electrical measurements.~      The phrenic nerve is not part of the heart but runs near to this area on the way to a large~     muscle, called diaphragm, which separates the lung space from the space containing stomach,~     liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to~     this nerve, it can cause a small part of it to contract giving you an uncomfortable~     hiccupping sensation.~      In many patients, phrenic nerve stimulation is not identified until after the implant~     procedure when movement and postural changes bring the LV lead into closer contact with the~     phrenic nerve.~      The investigation is performed to demonstrate the equality of performance of two different~     modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)~     optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.~   "
65819|NCT02195830|"~     There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid~     volume status in patients with sepsis.~      To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we~     first need to define the inferior vena cava collapsibility index in this population of~     patients.~      The research question is: In adult patients with sepsis, severe sepsis and septic shock what~     is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid~     resuscitation.~   "
65820|NCT02195817|"~     To determine the reduction in alcohol consumption in patients with alcohol dependence~     treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial~     support in primary care~   "
65821|NCT02195804|"~     The objective of this study is to establish the relative bioavailability (BA) of two~     different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over~     the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation~     following oral single dose administration in fasting healthy male volunteers~   "
65822|NCT02195791|"~     Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease~     inflammation. It has been proven to be an effective neuroprotective agent in animal model of~     ischemic stroke. In this study, the investigators will conduct a phase II clinical trial~     (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of~     pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke~     patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and~     will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and~     control group (placebo). The investigators expect to prove the neuroprotective efficacy of~     Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with~     good neurological outcome in patients with Pioglitazone treatment from the investigators~     clinical trial.~   "
65932|NCT02194322|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing~     doses in healthy male and female volunteers~   "
65824|NCT02195765|"~     This is a split-mouth, double-blind randomized controlled trial. Computerized linear~     radiographic measurements were used to detect infrabony defects treated with open flap~     debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months.~     Ten patients presenting 2 or more defects were selected (43 defects). An individualized film~     holder was used to take standardized radiographs at baseline and after 24 months. Images~     were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to~     the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.~   "
65825|NCT02195752|"~     A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients~     prescribed compounded pharmaceutical creams for the treatment of pain. The project is~     designed to accumulate tracking information from both patients and physicians over the~     course of therapy as a supplement to the ordinary care that the patients will normally~     receive. We seek to discover aspects of successful and unsuccessful treatment using topical~     pain creams. This information will be analyzed and reports prepared of observations and~     emergent findings. These reports will be sent during the study every 1 or 2 months to~     patients, physicians and pharmacists who are participating in the Study. A final compilation~     of findings and observations will be circulated to participating patients, physicians and~     pharmacists.~   "
65826|NCT02195739|"~     The aim of this study is to compare the cardiovascular disease event rate in smokers~     undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group)~     with the event rate in smokers attempting smoking cessation assisted by pharmacological~     interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray,~     transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation~     aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary~     care population.~   "
65827|NCT02195726|"~     The purpose of the present study is to determine if remote ischemic preconditioning reduces~     incidence of acute kidney injury in patients with reduced kidney function undergoing~     Percutaneous Coronary Intervention.~   "
65828|NCT02195713|"~     Urine output and urine drain line pressure were monitored while urine was drained into~     either:~        1. Accuryn Urine Output Monitor (Potrero Medical) OR~        2. Criticore Monitor (Bard Medical)~   "
65829|NCT02195700|"~     The purpose of this study is to determine whether an investigational drug, SD-809~     (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive~     dyskinesia.~   "
65830|NCT02195687|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared~     with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).~   "
65831|NCT02195674|"~     The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant~     correlation between post-study massage-seeking and changes in pain reported by participants~     during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study~     (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief~     during the parent study and post-study massage-seeking behavior.~   "
65832|NCT02195661|"~     This study aims to determine the safety and effectiveness of oral melatonin as natural~     inducer of sleep to acquire useful EEGs in South African children following its introduction~     as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.~     This is an observational retrospective study.~   "
65833|NCT02195648|"~     The main objective of this study is to determine the effects caused in neck movement, neck~     pain, headache in patients with tension type headache and cervicogenic headache after~     application of sub-occipital muscle inhibition technique associated with interferential~     electrotherapy.~   "
65834|NCT02195635|"~     To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the~     pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to~     administration of single-dose telotristat etiprate in healthy male and female subjects~   "
65835|NCT02195622|"~     To compare efficiency, in terms of tissue morcellation and removal time, of two commercially~     available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing~     HoLEP procedure for benign prostatic hyperplasia (BPH).~   "
65836|NCT02195609|"~     This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women~     treated for 4 months with Omega-3 vs Soy Isoflavones.~   "
65837|NCT02195596|"~     A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with~     resistance, progressive and moderate intensity intervals, carried out in primary care, is~     effective in terms of a smaller increase in respect to the baseline measurement in the total~     score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive~     section),in the control group that receives an intervention similar to low intensity (30-40%~     of Heart rate reserve).~      We Expect a difference of at least 3 points between the means of the increments between the~     intervention and control group.~   "
65838|NCT02195583|"~     This study will evaluate the effect of experimental sodium fluoride-silica dentifrice~     formulations, with and without zinc, on remineralization of enamel in situ. Following the~     remineralization phase, the acid resistance of the new mineral formed will be assessed.~     Fluoride uptake during the remineralization phase will also be measured.~   "
65852|NCT02195388|"~     Myocardial infarction is related with endothelial function, arterial stiffness and autonomic~     nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is~     also related with endothelial function, arterial stiffness and autonomic nervous system~     dysfunction.~      Primary aim of study is to investigate how complex cardiac rehabilitation influence~     endothelial function, arterial stiffness and autonomic nervous system activity according to~     presence or absence arterial hypertension.~      Secondary aim is to obtain correlation between methods for the assessment of particular~     disorders and intercorrelation between different disorders for example endothelial function~     and autonomic nervous system activity.~   "
65853|NCT02195375|"~     The purpose of this study is to investigate whether flutiform® is effective and safe in the~     treatment of chronic obstructive pulmonary disease (COPD).~   "
65933|NCT02194309|"~     To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine~     following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5~     mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg~     amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days~   "
65839|NCT02195570|"~     The long-term goal of this research is to reduce tobacco-related disparities in maternal and~     infant health outcomes by improving smoking cessation and relapse prevention interventions~     for minority pregnant and postpartum women, who have been significantly underrepresented in~     smoking cessation research. This study will examine the feasibility and efficacy of a~     prize-based contingency management approach for increasing smoking cessation and preventing~     relapse among socioeconomically disadvantaged minority pregnant smokers. First, the~     intervention will be pretested with 10 pregnant low-income minority smokers and then refined~     based on acceptability survey and focus group data. Next, a pilot study will be conducted.~     60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a~     large teaching hospital, who report daily smoking and who meet other eligibility criteria~     will be enrolled and randomized to one of two study conditions: 1) Standard~     Psychoeducational Intervention (6-week, individually-administered, pregnancy-specific Quit~     Smoking Now curriculum, as currently implemented in the clinic; QSN Only); 2) Standard~     Psychoeducational Intervention plus Contingency Management (provision of incentives~     contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired~     carbon monoxide and salivary cotinine levels will occur in both groups beginning on the~     first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM~     group will be reinforced for biochemically-verified abstinence with chances to win prizes~     ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study~     outcomes will be assessed through follow-up research exams (delivery and 6-months~     postpartum) and hospital chart reviews. The primary hypothesis is that that women randomized~     to the QSN-CM condition will have higher rates of abstinence during pregnancy and postpartum~     compared to women receiving standard of care alone. Results should advance scientific~     knowledge regarding effective methods for promoting and maintaining smoking abstinence among~     pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to~     support a larger randomized controlled trial.~   "
65840|NCT02195557|"~     Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among~     the patients with knee osteoarthritis (OA) since at least three years.~   "
65841|NCT02195544|"~     Study of prescription methods in everyday medical practice, tolerance profile and effect of~     Synvisc® until six months of follow-up.~   "
65842|NCT02195531|"~     The study hypothesis: in groups receiving tailored education and feedback in a style that~     matches their psychological profile, will show a higher CPAP adherence rates than groups~     receiving mismatched tailored education / feedback, and groups that receive no tailored~     education and feedback (standard of care).~   "
65843|NCT02195518|"~     This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF~     in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues~     (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects~     will be assessed for eligibility at a screening visit, with eligible subjects returning for~     a baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase~     all enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally~     once daily. All the eligible study subjects will undergo safety and efficacy assessments~     every 12 weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of~     tenofovir (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding~     and after incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain.~     TDF is a highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB~     patients. The purpose of our study is to evaluate the efficacy of TDF treatment in Chinese~     CHB patients following failure of multiple NAs. In addition, the study will also explore the~     relationship of baseline factors and early HBV DNA suppression to long-term virological~     response. The efficacy of TDF in multi-drug resistant patients will be analysed separately.~     The data generated by this study could then be used to optimize the clinical application of~     TDF and provide new evidence for management of the HBV infections following failure of~     multiple NAs. The result of this study will help Chinese physicians better manage the CHB~     patients following failure of multiple NAs.~   "
65844|NCT02195505|"~     The USAGE study aims at assessing on a long-term period (two years in average) the outcome~     in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with~     Synvisc®, in the 1139.4 clinical trial.~   "
65845|NCT02195492|"~     Retrospective collection of data, aimed at a better knowledge of the context of use of~     Synvisc® among the patients practising a regular activity (professional/leisure), and at~     evaluating the different practices and their results.~   "
65846|NCT02195479|"~     The purpose of this study is to determine if the addition of daratumumab to velcade~     (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS)~     compared with VMP alone in participants with previously untreated multiple myeloma who are~     ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).~   "
65847|NCT02195466|"~     Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the~     steady-state pharmacokinetics of fluconazole~   "
65848|NCT02195453|"~     The purpose of this study is to observe quality of life and treatment side effects in~     patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and~     Yangzhengxiaoji capsule.~   "
65849|NCT02195440|"~     The purpose of this study is to investigate the safety and tolerability of PRI-724 in~     patients with HCV-induced cirrhosis.~   "
65850|NCT02195414|"~     The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will~     enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical~     feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary~     scaffold in the treatment of patients with de novo coronary lesion.~   "
65851|NCT02195401|"~     A child and their parent were asked to participate in a research project that sought to~     study whether sleeping in a very clean environment for 14 days improved the elimination of~     chemicals and metals from the child's body. The child had an approximately two hour~     evaluation to confirm his or her diagnosis of Autism or Pervasive Developmental Disorder.~     Not Otherwise Specified. When one of these diagnoses was confirmed the child was scheduled~     to spend 14 nights sleeping in a very clean environment in a specially created room at The~     Children's Institute.~      Several hours prior to the first night the child slept in the clean room the child's mother,~     father, or guardian filled out behavioral rating scales about the child with the assistance~     of the study's research coordinator. The child also had approximately two tablespoons of~     blood drawn from an arm and a few inch sample of hair was taken from the back of the child's~     head. The child and a parent or guardian arrived at The Children's Institute about one half~     hour prior to the child's normal time of settling for bed for 14 consecutive nights. The~     child and a parent or guardian slept in the clean room, wearing the provided very clean~     clothes and sleeping on special mattresses and sheets each night for 14 consecutive nights.~     The child and parent were observed by a nurse through a window during the time in the clean~     room. The child and parent participated in regular daytime activities during these 14 days~     of the study. On the morning after the last night the child and a parent or guardian slept~     in the clean room a parent or guardian filled out behavioral rating scales with the help of~     the research coordinator. Approximately two tablespoons of blood were drawn from an arm and~     a few inch sample of hair was obtained from the back of the child's head, at The Children's~     Institute or at home.~   "
65864|NCT02195219|"~     The aim of this study is to compare two therapeutical procedures for the grade III~     acromioclavicular dislocations, either open reduction and internal fixation with a~     coracoclavicular device (MINAR-STORZ ) or non operative treatment.~      For these purpose we have designed an interventional, prospective, parallel assignment,~     opened and randomized study.~   "
65854|NCT02195349|"~     This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled,~     single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized~     Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that~     is specific to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first~     administration of GSK2831781 in humans and will evaluate in two parts the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV~     doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus~     Calmette Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with~     plaque psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the~     mechanism in biopsies and clinical response endpoints in these populations, as well as~     investigate systemic biomarkers will provide useful information prior to conducting studies~     in other immune-inflammatory disease which will involve more invasive tissue biopsies.~     Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin~     biopsies from Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin~     biopsies from patients with psoriasis, will be helpful in understanding of the dose response~     relationship, which will be important for designing future studies in immuno-inflammatory~     diseases, including psoriasis. Approximately 63 subjects will be enrolled to complete dosing~     and critical assessments. The subject numbers will be split to approximately 31 healthy~     subjects (Part A) and 32 patients with psoriasis (Part B)~   "
65855|NCT02195336|"~     To date, there are no methods to reliably select which patients with non-squamous non-small~     cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown~     that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome~     in some tumour types, including advanced NSCLC.~      Recent data are suggestive of a predictive value of imaging techniques for early detection~     of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no~     presented data available on correlation between changes in diffusion-weighted MR and~     response to bevacizumab treatment in lung cancer. The current study is designed as a pilot~     study to prospectively investigate changes in MR variables during treatment with bevacizumab~     and to detect signals of prognostic and/or predictive value of MR changes during treatment.~   "
65856|NCT02195323|"~     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)~     therapy in chronic kidney disease (CKD).~   "
65857|NCT02195310|"~     The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS)~     versus standard wound care for the incision in subjects undergoing a sternal midline~     incision (sternotomy). The subjects targetted for the study are at high risk for surgical~     complications (like infections) around the environment of the incision.~      The study is conducted in The Netherlands, Germany and Austria.~   "
65858|NCT02195297|"~     Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental~     evaluations the activity of an anticellulitis cosmetic product vs a reference product of~     the market (comparison within subjects), applied once a day, for an uninterrupted period of~     4 weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic~     lipodystrophy on the thighs.~      It was also aim of the study to evaluate cosmetic acceptability by the volunteers and~     products efficacy and tolerance both by investigator and volunteers.~   "
65859|NCT02195284|"~     This study is designed to assess the proportion of asthma subjects making critical and~     non-critical errors made in using ELLIPTA® inhaler compared with other commercially~     available inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and~     DISKUS/ACCUHALER®. This study will also assess the ease of use and preference between the~     ELLIPTA inhaler and the other commercially available inhaler devices. This is a randomized,~     open-label, placebo, crossover, multicentre study with a single visit. The study will~     comprise three sub-studies. Subjects will receive inactive treatment (placebo) via the~     ELLIPTA inhaler and one of the other inhaler devices depending on the sub-study they are~     allocated to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other~     inhalers that will be used in this study will be included. The study will be conducted in~     the Netherlands and the UK, and comprises one visit only. A sufficient number of subjects~     (at least 190) with asthma will be screened and 180 will be randomized to one of the three~     sub-studies. Eligible subjects will be allocated to one of the sub-studies in the following~     order depending on their experience of using the other inhaler (i.e., depending on which~     other inhaler they are naïve to).~      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.~     TURBUHALER is a registered trademark of AstraZeneca.~   "
65860|NCT02195271|"~     Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is~     is associated with a wide range of diseases and their social consequences is a public health~     problem.~      With the progress of neuroscience and studies on the plasticity of the central nervous~     system, it has been provided a better understanding of the neurobiological mechanisms of~     pain.~      The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both~     in physiological and pathological situations, with modulating effects on the process of~     nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and~     GABAergic, exerting anti-inflammatory action, analgesic activity among others.~      The advent of neuromodulation techniques such as transcranial direct current stimulation~     (tDCS), which promote changes in neuronal activity and signaling to be effective in~     conditions of chronic pain by attenuating changes in cortical excitability.~      There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus,~     considering the potential for each isolated intervention and the lack of knowledge of their~     combined effect, the authors propose the present study to investigate the effect of this~     combination on the heat-pain detection threshold and the neuroplasticity in the healthy~     subjects.~   "
65861|NCT02195258|"~     this study is designed to identify the genetic factors which can be implicated in the~     salbutamol responsiveness for asthmatic children in pediatric emergency department~   "
65862|NCT02195245|"~     CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers~     pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic~     drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to~     the problem of organ-toxin production in anesthetic circuits.~   "
65863|NCT02195232|"~     This research study is evaluating a drug called isoquercetin to prevent venous thrombosis~     (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal~     cancer.~   "
65865|NCT02195206|"~     In this pilot study, MRI of the lungs of healthy adult volunteers will be performed at 1.5~     Tesla to assess image quality using a prototype chest coil and pulse sequence following~     inhalation of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital~     for Sick Children, Toronto, Canada. Twenty subjects aged 18 to 75 will participate in this~     study. Xenon MRI is a non-invasive imaging technique that does not involve X-rays or~     ionizing radiation. Rather, this imaging method utilizes the same hardware and software~     principles that are used for conventional proton MRI of patients in a hospital. The~     investigators are testing the abilities of xenon MRI to see if it will produce lung images~     of equal or better quality to that of proton MRI.~      The investigators hypothesize that they will get good quality images of the lungs for~     analysis using our method.~   "
65866|NCT02195193|"~     The overall goal of this study is to develop, pilot test, implement, and evaluate a~     nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes~     (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and~     cost in rural China. This study is a large multi-center, randomized clinical trial among~     4,000 ACS patients from 20 rural county hospitals selected from a well-established research~     network across China.~   "
65867|NCT02195180|"~     A new approach that aims to destroy pancreatic tumor cells through modification of the tumor~     environment.~      Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an~     essential nutriment for pancreatic cancer cells which have no or low level of ASNS.~      by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.~      in selected patients having no or low ASNS, may provide a new therapeutic approach.~   "
65868|NCT02195167|"~     Pediatric PK study of SEP-225289 (Dasotraline)~   "
65869|NCT02195154|"~     Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the~     study. Each evaluable subject involved in this study must fulfill all the inclusion and~     exclusion criteria and each subject will have 3 visits in the study, as one screening visit,~     one imaging visit, and one safety evaluation visit.~   "
65870|NCT02195141|"~     Pathological complete response, (pCR) correlates with a favorable overall prognosis in~     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining~     a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of~     preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological~     complete remission rate.~   "
65871|NCT02195115|"~     The goal of this study is to challenge the existing clinical practice of employing~     laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to~     a regimen of active non-surgical therapy.~   "
65872|NCT02195102|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     Replacement (TAVR) in the Asian Pacific population~   "
65873|NCT02195089|"~     The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for~     the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).~   "
65874|NCT02195076|"~     The investigators have developed an early detection solution for lung and breast cancer. A~     system which can distinguish between different medical odors based on biosensors. Our~     product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The~     technology enables a high level of sensitivity and provides users with a quick lab response~     and a simple yes or no answer.~      The aim of this study is to contribute and detect the patient at the earliest possible~     stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples~     are a promising approach towards future possible lung and breast cancer screening method.~   "
65875|NCT02195063|"~     This is a survey study that will be given to patients who have been prescribed a topical~     compound for pain management, wound care or scar care or to patients who have been requested~     to do a urinary drug test (UDT) by their provider.~      The initial survey for pain management, wound care, scar care or UDT will be given to the~     patient by their providers during their office visit.~   "
65876|NCT02195050|"~     1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels~          in the following populations:~             1. Tertiary centre lipid clinic patients with raised TG treated with statins.~             2. Patients with type 2 diabetes treated with statins.~             3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins.~        2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated~          patients have residual cardiovascular risk related to raised hsCRP. The relationship~          between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by~          apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin~          treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients~          achieving LDL targets but not apo B targets.~        3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting~          serum triglyceride >5.5 mmol/l) have evidence of greater nerve damage compared with~          matched controls.~        4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low~          HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver~          enzymes.~   "
65877|NCT02195037|"~     Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay~     of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the~     newborn to receive his/her own blood from the placenta (placental transfusion) which helps~     their transition in the first hours of life. The purpose of the study is to learn about the~     amount of blood flow to and from the baby's heart during normal newborn transition~   "
65878|NCT02195024|"~     Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI)~     in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker~     system, to assess MR-image quality and to prove the safety of MRI in this specific~     population in the short term as well as during long term follow-up.~   "
65879|NCT02195011|"~     The purpose of this study is to determine the safety of regorafenib, an antiangiogenic drug,~     when combined with radioembolization using SIR-Spheres® microspheres in the treatment of~     colorectal cancer (CRC) that has spread to the liver.~   "
65890|NCT02194868|"~     The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution~     in recipient and in the graft content can predict the outcome of human allogeneic HSCT and~     to set up an algorithm for clinical practice that would allow the prediction of acute GVHD~     risk according to the quantity and functionality~   "
65880|NCT02194998|"~     HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and~     routes of transmission. For this reason, many people infected with HIV are also infected~     with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with~     HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The~     purpose of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free~     HCV treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.~   "
65881|NCT02194985|"~     This is an open-label extension study intended to provide continued treatment with~     migalastat HCl for subjects with Fabry disease who completed treatment of a previous~     migalastat HCl monotherapy study.~      The study will assess the long-term safety and effectiveness of migalastat HCl in subjects~     with Fabry disease who completed migalastat HCl treatment in a previous study.~   "
65882|NCT02194972|"~     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary~     fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with~     slow-transit constipation.~   "
65883|NCT02194959|"~     Cancer health disparities related to race and ethnicity are among the most serious problems~     facing the US health care system. A recent institute of medicine report stated that such~     disparities are seen at every level of health care, from prevention to treatment and~     follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among~     African Americans. According to the American cancer society, African Americans have the~     highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and~     mortality are 15% and 43% higher among African Americans than whites, respectively. These~     disparities could be effectively reduced through greater African American participation in~     CRC screening and early detection. More importantly, due to the preponderance of CRC in~     African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to~     colonoscopy among African Americans will save lives. Although there is clear evidence that~     providing patients with someone to help them manage/navigate the health care system (i.e.,~     patient navigation (PN)) is effective in helping them to complete cancer screening, very few~     hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to~     provide PN for patients for whom colonoscopy is recommended, in large part because of the~     costs associated with professional-led PN. This project seeks to address this serious public~     health problem by investigating the success of training African Americans who have undergone~     colonoscopy to serve as volunteer peer patient navigators to encourage others from their~     community to complete CRC screening via colonoscopy.~   "
65884|NCT02194946|"~     Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents~     overt clinical symptoms and is a critical stage when patients are encountered with dialysis.~     The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the~     most important dialysis-related question. As indicated by the recently published European~     Renal Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but~     greater expenditure and sometimes more harm.Renal replacement therapies (RRT) including~     dialysis are the most common procedures for patients with end-stage renal disease (ESRD),~     but conservative management should be an option in patients who still experience the stable~     period without clinical indications of dialysis.Chinese Medicine (CM) is recognized as an~     alternative therapy on alleviating uremic symptoms, deferring dialysis initiation, and~     improving quality of life. Although the effects of CM on kidney disease have been~     demonstrated in animal experiments, evidence from large clinical trial is insufficient. So~     we raise the hypothesis that CM therapies including Chinese herbal formula, Chinese patent~     medicine via oral pattern and/or Colonic administration, will defer the initiation of~     dialysis in adults with stage 5 CKD.~   "
65885|NCT02194933|"~     The purpose of this study is to evaluate the effect of brexpiprazole, via functional~     magnetic resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC)~     activated by impulsive behavior.~   "
65886|NCT02194920|"~     The purpose of this study is to evaluate safety and effectiveness of normal parathyroid~     tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of~     parathyroid gland during thyroid surgery.~   "
65887|NCT02194907|"~     This study will determine whether brain activity can be modified and improves performance on~     a task by showing participants live 'video feed' of their brains on advanced imaging~     technology. The study is particularly interested in brain regions that have been shown to be~     relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.~     Advanced technology will map the brain using magnetic pulses with a real-time functional~     Magnetic Resonance Imaging (rt-fMRI) machine.~   "
65888|NCT02194894|"~     In this first pilot study, we will examine the effects of acetaminophen dosing in adult~     patients with NAFLD in comparison to the effects in a healthy control group. Both groups~     will receive 3 grams (g) of acetaminophen, the maximum recommended daily dose, daily for 14~     days. We hypothesize that NAFLD patients are more prone to APAP toxicity than normal~     controls.Treatment will be stopped after two weeks or in the following conditions:~      Treatment with APAP will be stopped in healthy volunteers if ALT and/or AST reached three~     times the ULN. In patients with NAFLD, treatment will be stopped if: ALT or AST reach ≥~     three times the upper limit of entry value or ≥ 5 times the ULN; or if there is ALT or AST~     >3 times ULN and TBili >2xULN or INR >1.5; or if there is ALT or AST >3 times ULN with the~     appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever,~     rash, and/or eosinophilia (>5%). We follow a conservative approach derived from the FDA~     guidelines for stopping medications expected to cause drug induced liver injury (DILI).~     Indeed, the FDA allows continuation of the medication until ALT or AST are >8x ULN in the~     absence of elevated Tbili or INR. Patients who have hepatotoxicity will have close~     monitoring of their liver enzymes until they normalize. Taking acetaminophen up to 3g daily~     has been shown to be safe and acceptable. We have followed very strict criteria for~     monitoring and stopping rules however in the usually cases of toxicity the patient will be~     admitted for monitoring.~   "
65889|NCT02194881|"~     The purpose of this study is to determine whether the treatment with Ivacaftor remains~     effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR~     mutation) in the real life setting, after the drug has been approved by the Health~     authorities.~   "
65891|NCT02194855|"~     The investigators investigated whether laparoscopic versus open surgical approaches affected~     the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or~     cisatracurium.~   "
65893|NCT02194829|"~     This partially randomized phase I/II trial studies the side effects and best dose of WEE1~     inhibitor MK-1775 when given together with paclitaxel albumin-stabilized nanoparticle~     formulation and gemcitabine hydrochloride and how well they work in treating patients with~     previously untreated pancreatic cancer that has spread to another place in the body or~     cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel~     albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. WEE1 inhibitor MK-1775 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride~     are more effective with or without WEE1 inhibitor MK-1775 in treating patients with~     pancreatic cancer.~   "
65894|NCT02194816|"~     We are trying to identify factors associated with improved quality of life and fewer PD~     symptoms. We are attempting to identify practices, beliefs, and therapies used by~     individuals who report excellent quality of life, few PD symptoms, and reduced rates of~     progression. After agreeing to participate, we will ask participants to fill our~     questionnaires about their experience with PD, their health in general, along with their~     food intake every six months for five years.~   "
65895|NCT02194803|"~     A multicentre, open-label, non-interventional study to observe treatment patterns in~     patients with wet age-related macular degeneration (wAMD), with visual impairment due to~     diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or~     due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated~     intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a~     24 months observational period under real life conditions.~   "
65896|NCT02194790|"~     Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have~     demonstrated that integrated pre-dialysis care may slow the decline in renal function~     (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early~     intervention especially in high risk groups like Diabetic may also improve outcome of these~     patients in primary health care setting resulting in delay of CKD progression.~   "
65897|NCT02194777|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing~     doses in healthy male and female volunteers~   "
65898|NCT02194764|"~     The purpose of this study is to develop a cost-effective breath-based medication adherence~     monitoring system that can monitor whether recovering opiate addicts actually take a~     specific treatment medication called naltrexone.~   "
65899|NCT02194751|"~     This Phase II trial studies the overall tumor response of vaccine therapy in patientswith~     previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The~     vaccine contains an extract of the patient's own cancer cells and the immunostimulant~     protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine~     will enable the patient's immune system to recognize and destroy the cancer cells. The trial~     will also assess the safety of the vaccine, the time from vaccine treatment until the~     patient requires another type of anti-lymphoma treatment, progression-free survival, and the~     anti-tumor immune response.~   "
65900|NCT02194738|"~     This research trial studies genetic testing in screening patients with stage IB-IIIA~     non-small cell lung cancer that has been or will be removed by surgery. Studying the genes~     in a patient's tumor cells may help doctors select the best treatment for patients that have~     certain genetic changes.~   "
65901|NCT02194725|"~     Background:~      - Children with Duchenne/Becker Muscular Dystrophy (DBMD) slowly lose muscle function. They~     usually die at a young age. Some mothers adapt to the demands of caring for a child with~     this disease better than others. Studies show that a person s hope may positively affect how~     they cope and adapt. Researchers want to find out more about this. They want to develop ways~     to improve caregivers overall wellness.~      Objective:~      - To study the relationships between uncertainty, hope, and coping ability in mothers of~     children with DBMD.~      Eligibility:~      - Women in the United States 18 years and older. They must be biological mothers of a living~     child with DBMD and be able to answer a survey in English.~      Design:~        -  This study is part of a larger study that examines the well-being of mothers with sons~          who have DBMD.~        -  Participants will take a questionnaire. The questionnaire can be done on paper or on a~          computer. It will take 30 45 minutes to complete.~        -  The questionnaire will include basic demographic questions about the participant and~          the child. There will also be questions about how the participant copes with the stress~          and uncertainty of DBMD.~        -  For most of the questions, participants will rate their feelings on a scale. There will~          also be four open-ended questions.~   "
65902|NCT02194712|"~     Schistosomiasis is increasingly encountered among travellers returning from the tropics and~     is known for its focal endemicity, associated with the presence of the snail intermediate~     host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic~     due to the low intensity of infection, many infections likely go undiagnosed and will~     develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in~     travellers with praziquantel 40mg/kg daily dose is known for its modest success rate.~     Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low~     burden infections, or serology, which is inadequate to monitor cure. The department of~     parasitology of the Leiden University Medical Center has developed a novel diagnostic test~     based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen~     (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis~     infections and confirm cure after praziquantel treatment. This study will assess the~     performance of UCP-CAA in travellers with high-risk water contact.~   "
65903|NCT02194699|"~     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase~     3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with~     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist~   "
65904|NCT02194686|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are~          inversely associated with coronary risk factors and atherosclerotic diseases.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and endothelial function as well as the potential~          mechanisms of action in patients with high risk for cardiovascular disease.~   "
65906|NCT02194660|"~     Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and~     its Beihu Branch (BB).~      Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13~     'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan~     University Hospital (NTUH) health care system. The main hospital (MH) program enrolled~     patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3)~     clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB)~     program enrolled only the later two types of patients from outpatients. During the whole~     study period, two programs planed to enroll 600 fracture patients. Each patient would be~     assessed at baseline, and every 4 month for at least one year.~   "
65907|NCT02194647|"~     BACKGROUND:~      One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent~     years, efforts have been made to change the delivery of these medications from oral form to~     injection form every, 3, 6 or 12 months to increase adherence. However, both patients and~     providers are sometimes confused about the multiple choices. Also, patients may receive~     extra medications if providers did not keep tract of their previous AOM uses or patients may~     changes providers. There were urgent needs to provide AOM monitoring and management services~     to improve cares.~      OBJECTIVES:~      To establish a anti-osteoporosis medication management service at National Taiwan University~     Hospital and its BeiHu Branch.~      METHODS:~      Participating physicians will select those eligible for services and refer to study~     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture~     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,~     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic~     visit, telephone reminder and follow up for patients, and communicate with providers on~     regular bases. the investigators plan to enroll 500 patients with 18-month follow up for~     each.~   "
65908|NCT02194634|"~     This study is designed to assess safety and efficacy of intravitreal injection of Conbercept~     on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .~   "
65909|NCT02194621|"~     The primary objective was to evaluate the antibacterial effects of two toothpastes~     containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as~     compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours~     after 13 days of product use. A secondary objective was to demonstrate that a toothpaste~     containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with~     odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides~     a level of antibacterial efficacy that is equivalent to a toothpaste containing 0.3%~     triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate~     Total Toothpaste-Flavor Option 2) after 13 days of product use.~   "
65910|NCT02194608|"~     The primary goal is to evaluate whether a home telehealth system that enables the~     participant to monitor their body weight, blood glucose values and blood pressure values,~     associated with remote educational support and feedback to the general practitioner, can~     improve metabolic control and overall cardiovascular risk in individuals with type 2~     diabetes mellitus (T2DM), as compared to usual practice.~   "
65911|NCT02194595|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a randomized controlled trial to determine whether~     combining basal insulin with a new medication called exenatide is a therapeutic strategy~     that can preserve beta-cell function early in the course of type 2 diabetes.~   "
65912|NCT02194582|"~     The investigators are trying to learn more about the cause of kidney diseases such as Focal~     Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The~     investigators are interested in discovering which genes play a role in causing a~     predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in~     families. Participation in our study involves a saliva sample and a urine sample that you~     can give from home. There is no cost to participate. All information is kept private and~     confidential. The investigators also like to include healthy volunteers (parents, spouses)~     if interested/available but of course this is completely optional.~   "
65913|NCT02194569|"~     Rationale:~      A higher citrate dose during continuous venovenous hemofiltration provides better~     anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic~     limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a~     negative magnesium balance is unwanted.~      Objective:~      Aim of this study is to determine the magnesium balance of citrate-based continuous~     veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium~     balance depends on citrate dose.~      Study design and methods:~      A prospective randomized study conducted in critically ill patients with acute kidney injury~     (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter)~     or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a~     postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL~     (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations~     in the patient are tested for the following variables:~      (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca~     (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and~     creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the~     time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and~     24 hrs or at protocol exit.~      Sample sites: arterial line, postfilter port (after postdilution and calcium compensation),~     effluent sample. All flow rates to be noted.~      Study population:~      Twenty patients admitted to intensive care, requiring continuous renal replacement therapy~     (CRRT) for AKI.~      Intervention:~      Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat~     (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both~     regimens are within standard protocolled CVVH treatment in the intensive care department.~   "
65914|NCT02194556|"~     This randomised, controlled, open-label, prospective trial is designed to assess the~     efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus~     chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV~     non-small cell lung cancer patients with EGFR mutation.~   "
65915|NCT02194543|"~     To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract~     surgery~   "
65934|NCT02194296|"~     Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge~     compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation~   "
65935|NCT02194283|"~     The main objectives of the present study are to determine pharmacokinetics of ambroxol in~     healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for~     four days~   "
65936|NCT02194270|"~     Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles~     15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol~     hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state~   "
65916|NCT02194530|"~     This pilot study is collaboration between the Weill Cornell Medical College, Department of~     Genetic Medicine and Yale University and will examine the pathways involved in allergic~     response, primarily in food allergy; specifically peanut allergy.We will also study~     non-allergic donors as well as patients with atopic disorders, primarily as control~     subjects.We believe that this study will lead to discovery of significant pathways involved~     in the allergic pathway that can be explored in more detail during follow-up studies in~     order to address mechanistic questions that cannot be answered in a pilot trial. We believe~     that such a pilot study represents the ideal approach to identify effective therapeutic~     interventions and to simultaneously better understand the underlying mechanistic properties~     involved in the allergy cascade. We think that this study forms the basis for a novel avenue~     of research into the pathogenesis of allergic pathways, a disease that is still associated~     with significant morbidity and mortality.~   "
65917|NCT02194517|"~     ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO)~     and fat/protein (FP) exchanges. It consists of ELKa software including database of various~     meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a~     real-time to a computer via universal serial bus (USB) port. After choosing the name of~     particular product from the list, the program gives precise information about the amount of~     CHO and FP exchanges in serving.~      The aim of the study is to investigate the benefit of using ELKa toolset in comparison with~     standard method of CHO and FP counting on metabolic control in type 1 diabetic children.~   "
65918|NCT02194504|"~     In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic~     health will be examined in male and female subjects with increased abdominal adiposity (BMI~     >27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver,~     gut and the adipose tissue, examined in a static state as well as after the application of a~     challenge test.~      The diets are equally caloric-restricted, but differ in nutrient composition. It is~     hypothesized that one of the two diets causes a larger improvement in organ health and~     reduction in liver fat.~   "
65919|NCT02194491|"~     The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use~     [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain~     prior to and following single oral dose administration of ASP3662.~   "
65920|NCT02194478|"~     This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week~     mind-body/meditation intervention on self-reported quality of life in individuals employed~     by Allina Health. Outcomes will include validated questionnaires for depressive~     symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as~     biological outcomes of salivary cortisol for a sub-sample of employees.~   "
65921|NCT02194465|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY2623091 in participants with high blood pressure.~   "
65922|NCT02194452|"~     This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission~     tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients.~     Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and~     diagnose brain tumors.~   "
65923|NCT02194439|"~     This study is designed to collect longitudinal biological samples from patients after~     hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant~     centers to validate biomarkers of both acute and chronic GVHD as well as for use in future~     unspecified research. The centers include Dana-Farber Cancer Institute and Boston's~     Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred~     Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical~     Center, and Indiana University Simon Cancer Center.~   "
65924|NCT02194426|"~     This research study is looking at a new DARPin based medication, called MP0250. There is~     evidence from preclinical studies that MP0250 may be effective in the treatment of cancer.~     This is the first study of MP0250 in humans and its main purpose is to test its safety and~     tolerability in patients with cancer. This study will also examine how the drug is changed~     by and removed from the body and look for indicators that the drug may be effective against~     cancer. This study will test several different dose levels of the study drug to determine~     the safety and tolerability profile of the drug.~   "
65925|NCT02194413|"~     This randomized pilot clinical trial studies healing touch or usual care in improving~     quality of life in patients undergoing stem cell transplant. Healing touch may improve the~     quality of life of patients undergoing stem cell transplant.~   "
65926|NCT02194400|"~     A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous~     infusions of RSLV-132 in subjects with inactive to mild SLE.~   "
65927|NCT02194387|"~     Objectives:~      Pilot 1 Primary aim: To explore the feasibility of using the Multi-phase Optimization~     Strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD~     Anderson employees.~      Pilot 2 Primary aim: To explore the feasibility of using the MOST approach to optimize~     energy balance interventions in a sample of BRCA (BReast CAncer) positive and Lynch Syndrome~     positive individuals and their family members.~      Pilot 3 Primary aim: To explore the feasibility of using the MOST approach to optimize~     energy balance interventions in a sample of CLL (Chronic Lymphocytic Leukemia) patients.~   "
65928|NCT02194374|"~     Gene transfer is a process in which the DNA (genetic material) of certain cells is changed.~     In this study, gene transfer will be performed on a type of white blood cell (called T~     cells) to recognize leukemia cells in the same person the T cells were collected from.~      The goal of this clinical research study is to learn if it is safe to give these~     genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if~     these cells can help to attack CLL/SLL cells.~   "
65929|NCT02194361|"~     Study to determine the Efficacy of Standardised Bilberry Extract in improving the night~     vision and to evaluate its tolerability and safety.~   "
65930|NCT02194348|"~     The objective of the present study was to obtain information about safety, tolerability and~     pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing~     doses in healthy male and female volunteers~   "
65937|NCT02194257|"~     Study to determine the basic pharmacokinetics of ambroxol and [14C]-radioactivity including~     mass balance, excretion pathways and complete metabolism in healthy male volunteers~     following administration of a lozenge of 20 mg ambroxol together with an oral solution of~     0.4 mg [14C]-ambroxol labelled in two different positions~   "
65940|NCT02194218|"~     Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as~     4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence~     of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single~     dose~   "
65941|NCT02194205|"~     To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT~     hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation~     Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state~     pharmacokinetics over one dosing interval following four weeks of therapy will be~     characterized.~   "
65942|NCT02194192|"~     Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a~     very common problem leading to several complications to both patients and their babies. It~     can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important~     complication is the decreasing blood flow to babies; which may lead to fetal acidosis.~      Many interventions has been studied in order to prevent hypotension after spinal anesthesia~     in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine,~     phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic~     drug) can be effectively used to prevent hypotension after spinal anesthesia in normal~     patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish~     reflex.~      This aim of this study is to compare the efficacy of ephedrine and ondansetron in the~     prevention of maternal hypotension after spinal anesthesia in cesarean section.~   "
65943|NCT02194179|"~     The objective was to establish the pharmacokinetic (PK) profile at steady state of two~     different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD)~     under fasted and fed conditions in comparison with the commercially available NVP immediate~     release (IR) tablet at 200 mg BID (400 mg/day).~   "
65944|NCT02194166|"~     This multicenter study in patients with HER2-positive eBC will investigate patients' pain~     and discomfort of subcutaneous (SC) trastuzumab (Herceptin) administered either via a~     single-use injection device (SID) or via vial for manual administration using a hand-held~     syringe (SC vial). In total, patients wil obtain at least 18 cycles/1 year of trastuzumab (4~     cycles of IV and 14 cycles of SC trastuzumab).~   "
65945|NCT02194153|"~     Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of~     treatment initiation and safety of prehospital and early hospital thrombolysis with~     Metalyse® in a real life setting outside clinical trials.~   "
65946|NCT02194140|"~     Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's~     localization by oral administration of iodinated contrast material.~   "
65947|NCT02194127|"~     Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision~     and to test its tolerability and safety.~   "
65948|NCT02194114|"~     The primary purpose of this study is to assess dietary protein requirements in clinically~     stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary~     protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that~     a safe intake that maintains balance in almost all MHD patients is about 1.25g~     protein/kg/day.~   "
65949|NCT02194101|"~     This is an observational pilot study of supernormal oxygen delivery goal for patients with~     proximal femoral fracture.~   "
65950|NCT02194088|"~     This research study is being done to assess if a combination of medications can enhance the~     relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The~     investigators also want to find out if certain genes may be linked to individual differences~     in experienced efficacy of pain killers. The combination of medications under investigation~     is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug~     Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain~     types of poisoning, heartbeat problems, and other diseases but atropine is not approved to~     treat pain. However, atropine has been used for many years in different European countries~     to treat painful conditions such as stomach cramps.This research study will compare~     diclofenac and atropine to placebo.~   "
65951|NCT02194075|"~     Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on~     pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients~     with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the~     hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of~     fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic~     strategy to improve outcome in OCD.~   "
65952|NCT02194062|"~     The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal~     saline rinses in both the upright and head forward positions in patients who have had~     functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis~     (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-~     Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4~     months, and 6 months post-op.~   "
65953|NCT02194049|"~     This phase I trial studies the side effects and the best dose of PI3K inhibitor BKM120 when~     given together with cisplatin and etoposide in treating patients with advanced solid tumors~     or small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing , or by stopping them from spreading. PI3K inhibitor BKM120 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving PI3K inhibitor BKM120 with cisplatin and etoposide may kill more tumor cells.~   "
65954|NCT02194036|"~     Outpatients that suffer from different anxiety disorders may have physical ailments that~     negatively affect daily life functioning and quality of life. LOF is a physical therapy~     approach focusing on the link between bodily and mental balance and through defined, but~     simple movements, patients are expected to learn how to cope and reduce health complaints.~      This study aims to investigate the short- and longterm effect of LOF compared to other~     standardized psychiatric treatments given in the clinic on levels of anxiety and depression,~     health related function and quality of life.~   "
66008|NCT02193334|"~     This study is randomized, double-blind, placebo-controlled Phase I/II study designed to~     evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation~     for intrathecal injection, as a treatment for acute spinal cord injury. The study is~     conducted at two clinical sites in Japan.~   "
65955|NCT02194023|"~     In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)~     mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield~     similar or better clinical results regarding the inhibition of de novo plaque growth~     compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid~     Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the~     marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological~     effects, and they control total bacterial loads.~   "
65956|NCT02194010|"~     The purpose of this research study is to create and validate two patient reported outcome~     (PRO) questionnaires. PRO questionnaires ask questions that help to measure disability in~     patients with inherited neuropathies. These questionnaires ask questions about what~     participants think disability is for themselves or others with inherited neuropathies. These~     questionnaires are a useful tool when evaluating whether treatments are working in the day~     to day life of an individual, although there are currently no questionnaires available~     specifically for people who have Charcot Marie Tooth disease (CMT).~   "
65957|NCT02193997|"~     This study examines the effects of dietary fiber in the treatment of functional childhood~     constipation.~   "
65958|NCT02193984|"~     Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family~     Physicians Foundation. The study was designed to help patients better manage their diabetes,~     and was a partnership between the Institute for Behavioral and Community Health and Clínicas~     de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive~     primary care services to residents throughout Imperial and Riverside Counties, California.~     The investigators identified 336 patients with uncontrolled diabetes from three CDSDP~     clinics. Patients were randomly assigned to intervention or control conditions. The 12-month~     intervention consisted of individual diabetes management support delivered by a trained~     volunteer peer supporter. The primary aim was determine if peer support can help patients~     better manage their diabetes and improve the quality of their lives. Intervention~     effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and~     12 months. This study was part of the global Peers for Progress network which has been~     testing peer support programs in 13 countries.~   "
65959|NCT02193971|"~     -  Study objectives~             1. To compare the safety and long-term efficacy of coronary stenting with biostable~               polymer everolimus-eluting coronary stent system (Promus PremierTM) with~               biodegradable polymer biolimus-eluting coronary stent system (Biomatrix®,~               Biomatrix Flex® and Nobori®) in patients with acute coronary syndrome~             2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared~               with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome~               undergoing percutaneous coronary intervention~        -  Study design :~      Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the~     following in CHD patients~        1. Non-inferiority of biostable polymer everolimus-eluting stent (Promus PremierTM)~          compared with biodegradable polymer biolimus-eluting coronary stent system~          (Biomatrix®,Biomatrix Flex® and Nobori®) in terms of patient-oriented composite outcome~        2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of~          major adverse cardiovascular events~   "
65960|NCT02193958|"~     A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory~     Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts~     will be enrolled in Phase 1 to establish the MTD. Phase 2 will consist of 2 cohorts: Cohort~     1 will include subjects with high-risk MDS/CMML who have relapsed or are refractory to prior~     therapy; Cohort 2 will include subjects with AML who have relapsed or are refractory to~     prior therapy or are ≥ 60 hears of age and not candidates for other therapies.~   "
65961|NCT02193945|"~     The purpose of this study is to retrospectively review and further characterize anatomic and~     symptomatic changes over six months immediately following treatment of symptomatic~     vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset~     and resolution of anatomy and symptoms.~   "
65962|NCT02193932|"~     A prospective exploratory study in patients with drug resistant epilepsy with a target~     comparison of long term outcome. NeuroScan software modules and a MagLink will be used to~     acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining~     integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the~     MRI machine, without compromising the raw EEG data.~   "
65963|NCT02193919|"~     Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments~     may help even more. Determining if a high protein diet vs a low protein diet results in~     improving psoriais may help lead to future dietary effects on psoriasis therapy~   "
65964|NCT02193906|"~     The purpose of the study is to determine the effect of an web-based intensive cognitive~     rehabilitation program in neuropsychological performance of a population of patients with~     multiple sclerosis or clinical isolated syndrome.~   "
65965|NCT02193893|"~     The purpose of this study is to test the safety and effectiveness of an autologous bone~     marrow-derived stem/progenitor cells infusion in the subjects with diagnosed amyotrophic~     lateral sclerosis.~   "
65966|NCT02193880|"~     The purpose of this study is to determine the safety and efficacy of post-transplant~     cyclophosphamide and a post-transplant infusion of donor cells, that have been specially~     processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic~     stem cell transplant to help reduce the risk of relapse without increasing the risk of~     graft-versus-host disease.~   "
65967|NCT02193867|"~     This is an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly~     progressive LAL Deficiency. Eligible subjects will receive once-weekly infusions of~     sebelipase alfa for up to 3 years.~   "
66009|NCT02193321|"~     The purpose of this study is to to evaluate the rate of new onset postoperative atrial~     fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial~     surface as compared to subjects who did not undergo epicardium intervention.~   "
66010|NCT02193308|"~     To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose~     combination (FDC) vs. its monocomponents~   "
66011|NCT02193295|"~     The purpose of this study is to examine whether weight reduction decreases intramyocellular~     (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue~     in people who are insulin resistant and have a family history of type 2 diabetes.~   "
65968|NCT02193854|"~     Objective This study is aimed to estimate the distance, time and the cost of travel saved by~     patients who are seeking tele-dermatology (TD) service though smart mobile phones in the~     resource poor settings at the rural clinics of Mongolia.~      Methods A cluster-randomised trial was conducted for six months at the 20 rural health~     clinics selected from three districts in Mongolia. With a computer-generated sequence,~     health clinics were randomly allocated either to the intervention group, in which all~     general practitioners (GPs) received TD consultation through Sana system, or the control~     group, in which GPs referred patients to the dermatologist at district hospital whenever~     needed. The primary outcome was to estimate the distance traveled, times spend and the cost~     of travel required in receiving dermal care for patients in rural Mongolia. Analysis was~     done to estimate the difference between the aforementioned parameters among intervention and~     control groups.~   "
65969|NCT02193841|"~     Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long~     bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one~     is better than another. The purpose of this research trial is to compare the effectiveness~     of two common treatments that are used by surgeons today.~   "
65970|NCT02193828|"~     The objectives of this study are to assess the safety and effectiveness of AA4500 in~     treating palmar Dupuytren's disease nodules.~   "
65971|NCT02193815|"~     This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the~     effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects~     with psoriasis vulgaris.~   "
65972|NCT02193802|"~     The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been~     demonstrated in a number of studies.~      Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of~     small bowel mucosal healing by conventional colonoscopy is an invasive technique which is~     not complete since it does not allow exploration of the small bowel beyond the terminal~     ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is~     lacking.~   "
65973|NCT02193789|"~     In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis~     site stricture is very severe complication. It can improve by temporary through the scope~     covered metallic stent. It is very effective procedure about the stricture. But stent~     migration is very severe complication. Herein the investigators suggest newly method to~     prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent~     stent migration. But it is difficult to remove stent after resolved stricture. So the~     investigators add the suture between hemoclip and stent. And the investigators cut the~     suture when stent removal.~   "
65974|NCT02193776|"~     The purpose of this study is to determine the mycobactericidal activity of combinations of~     bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks~     of treatment.~   "
65975|NCT02193763|"~     This is a prospective, randomized study evaluating the efficacy of bedside ultrasound~     assisted lumbar puncture in pediatric patients~   "
65976|NCT02193750|"~     The investigators hypothesize that a novel method for oligosaccharide supplementation, in~     the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides~     (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's~     disease (CD) in remission.~   "
65977|NCT02193737|"~     National guidelines about post-operative fasting after general anesthesia are missing.~      Current clinical practices are highly variable and no study has ever evaluated on a large~     scale the real risk of an early drinks recovery in postoperative period.~      The aim of this study is to state the impact of early drinks recovery after general~     anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.~   "
65978|NCT02193724|"~     The goal of this study is to determine if human RB1-deficient induced pluripotent stem cells~     (iPSCs) can produce retina, and, furthermore, can give rise to retinoblastoma in culture.~     This unique opportunity to study the initiation of retinoblastoma in the developing retina~     will shed light on the cell of origin for retinoblastoma and allow the investigators to~     study the earliest molecular and cellular events in retinoblastoma tumorigenesis.~      OBJECTIVES:~        -  To establish the feasibility of producing induced pluripotent stem cells (iPSCs) from~          retinoblastoma patients with germline RB1 mutations (RB1-deficient iPSCs).~        -  To validate human RB1-deficient iPSCs by confirming karyotype, pluripotency and RB1~          mutation.~        -  To differentiate the RB1-deficient iPSCs into retina as a model of the initiation of~          retinoblastoma in the developing retina.~   "
65979|NCT02193711|"~     The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy~     of a topical cream compared to a placebo cream. The study population will be those with mild~     to moderate osteoarthritis of the knee.~      The trial will also provide information about potential side effects and verify the safety~     of this composition. Blood levels will be done to assess inflammation and to determine~     whether any systemic absorption has occurred.~      Hypothesis/Purpose~        -  Pain scores after active treatment will be significantly reduced in comparison to~          placebo.~        -  There will be an improvement in stiffness and physical function as measured by the~          WOMAC using the active cream as compared to placebo.~        -  There will be a decrease in the level of inflammation assessed at baseline, end of week~          3 and end of week 6.~        -  The blood concentration of the active ingredient in the topical cream will not exceed~          the maximum daily dose that will be consumed by participants.~   "
65980|NCT02193698|"~     This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent~     or refractory POEMS (Crow-Fukase) syndrome.~   "
66012|NCT02193282|"~     This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo~     works in treating patients with stage IB-IIIA non-small cell lung cancer that has been~     completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
66013|NCT02193269|"~     To determine minocycline's effects on cognitive performance and measures of mood in~     abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also~     inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and~     nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may~     have utility as a treatment for cocaine addiction.~   "
65981|NCT02193685|"~     To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream~     characterization) risk factors that influence the likelihood of development of the HAEC~     phenotype in children who carry the diagnosis of HD. The newly formed HAEC Collaborative~     Research Group (HCRG) will utilize the 4 participating centers in the current consortia and~     recruit additional centers to enroll children diagnosed with Hirschsprung disease.~      1a: To recruit 200 patients with Hirschsprung disease without HAEC.~      1b: To recruit 200 patients with Hirschsprung disease and HAEC using standardized diagnostic~     criteria by collaborating with participating members of the HAEC Collaborative Research~     Group[1].~      1c: To collect clinical and demographic information from well-characterized HD patients both~     with and without HAEC.~      1d: To collect samples blood for DNA for genome wide association study (GWAS) by high~     throughput SNP technology and mutational analysis of known HSCR genes.~      1e: To collect serum samples at the time of recruitment in a subset cohort (n=50 HD only,~     n=50 HD + HAEC) for serological immune markers known for inflammatory bowel disease (IBD)~     including ANCA, ASCA, OMPC, I2, and CBir1 and any newly identified markers.~      1f: To collect and store fresh fecal specimens for future evaluation by molecular~     methodologies to determine relative proportions of enteric microflora in a subset cohort~     (n=50 HD only, n=50 HD + HAEC) of children (<18 years).~      1g: To establish a Centralized Data Coordinating Center for data collection, data quality~     and detailed data analyses (CSMC) and tissue bank (CSMC) to facilitate specimen analysis for~     this study.~      The HAEC risk factor identification will be completed by multivariate logistic regression~     analysis. Genetic association will be studied for each SNP in the GWAS together with all~     other potential risk factors. Further analysis will be carried out to evaluate multiple~     SNPs/genes simultaneously.~   "
65982|NCT02193672|"~     The goal of this clinical research study is to find out if using the tracer (liquid used in~     imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography~     (PET/CT) scans will help researchers learn more quickly if the disease is responding to~     treatment.~   "
65983|NCT02193659|"~     The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who~     had some lipidic profiles to the limit is highly conditioned by their nutritional~     acceptance. The main objective is to assess the effect of breakfast cereals intake with~     omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this~     way reduce the small dyslipidemia.~   "
65984|NCT02193646|"~     The investigators are retrospectively comparing detection rates of adenomatous polyps,~     advanced adenomas, and size assessment of the polyps among Rush University Medical Center~     endoscopists. The investigators plan to review whether the size assessment of adenomatous~     polyps affected the surveillance protocols and if the location of polyps detected affected~     the detection rates.~   "
65985|NCT02193633|"~     This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel~     anticancer agent, in combination with paclitaxel.~      AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,~     4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment~     break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will~     be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.~     Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off~     schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel~     infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses~     of AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.~      On completion of the dose escalation phase of the study patients with ovarian cancer and~     squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A~     minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to~     the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients~     will be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of~     the combination of AZD2014 and paclitaxel.~   "
65986|NCT02193620|"~     The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of~     Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.~   "
65987|NCT02193607|"~     1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O)~          procedure, when added to a planned improved reconstruction pelvic surgery, improves the~          rate of urinary stress continence in subjects with occult stress incontinence.~        2. Observe the immediate and short-term complications, overall urinary tract function, and~          other aspects of pelvic health between subjects with and without a TVT-O procedure.~   "
65988|NCT02193594|"~     Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of~     gastroesophageal junction and upper gastric cancers in the decade.According to some~     researches,CRT had shown its good curative effects in local control and prolonged overall~     survival.However,the optimization scheme for CRT and its influence to surgery remains~     controversial.Meanwhile,there were many design flaws in the past few research,such as the~     lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry~     out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and~     safety of CRT.~   "
65989|NCT02193581|"~     The use of MDS to access the presence of melanoma in the skin.~   "
65990|NCT02193568|"~     This randomized clinical trial studies light sedation compared with intubated general~     anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep~     sleep) in reducing complications and length of hospital stay in patients with brain cancer~     undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed~     so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients~     to remain awake during their surgery, while intubated general anesthesia puts patients to~     sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided.~     Additionally, patients not receiving intubated general anesthesia tend to recover more~     quickly after surgery. It is not yet known whether light sedation is better at reducing~     complications and length of hospital stay compared to intubated general anesthesia.~   "
65991|NCT02193555|"~     The aim of this study is to assess the visual performance of prototype soft contact lens~     designs compared to a commercially available contact lens~   "
66050|NCT02192788|"~     This study aims to probe the effect of SBRT as a treatment oligometastases of prostate~     cancer, regardless of basal treatment received, and I know the response, biochemical~     control, the progression-free survival as well as their impact on quality of life.~      Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated~     by SBRT.~      Secondary Objectives: Analyzing biochemical progression rates, progression-free survival,~     chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of~     patients before and after treatment~   "
66051|NCT02192775|"~     The purpose of this study is to determine the clinical efficacy of MV-NIS (measles~     virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when~     given with cyclophosphamide~   "
65992|NCT02193542|"~     Anesthesiologists commonly administer pain relief during labor or providing anesthesia for~     cesarean delivery. Two main methods are used to achieve these goal: Regional anesthesia~     where the mother is given medication through a needle or catheter in her back and the mother~     is kept awake, or General anesthesia, where the mother is given intravenous medication and~     is kept asleep.~      Regional anesthesia uses a needle to enter a narrow space in the mother's back where~     medications can be given. In some patients, it takes longer to find this target space in the~     back. In emergency situation, however, there is often little time to find this space, and~     the backup method would be the general anesthesia technique.~      If general anesthesia is required, a breathing tube needs to be inserted to help support the~     mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing~     this in advanced helps anesthesiologists create a safe plan for the patients. A lot of~     research has been done to determine factors that would predict which patients would need~     more time and preparation for general anesthesia and regional anesthesia.~      The purpose of this study is to study how common it is for the pregnant patients who have a~     difficult regional and general anesthesia.~   "
65993|NCT02193529|"~     Weight reducing surgery is the only effective therapy for morbid obese patients.~      Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There~     is poor knowledge about the nutritional status inpatients after LSG. The aim of our study~     was to investigate the relationship between dietary intake and weight loss after LSG.~   "
65994|NCT02193516|"~     Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can~     indicate possible nephropathy. The evolution of CMD across gestation had not been well~     established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20~     weeks. In our study we would like to determine the exact timing of it's sonographic~     visualisation. This is a prospective study recruiting women between 14-24 week gestation~     during routine ultrasound screening. A midsagittal image of each kidney will be taken by a~     single sonographer and examined for the presence of the CMD by two other sonographers~     blinded to gestational age.~   "
65995|NCT02193503|"~     The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1,~     administered sub-cutaneously (injections and capsules implantations), in patients with~     advanced metastatic solid tumor in progression who are not or not any longer amenable to any~     standard therapy of their tumour disease.~   "
65996|NCT02193490|"~     The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase~     eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.~   "
65997|NCT02193477|"~     The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint~     Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in~     patients undergoing radical surgery for gastric cancer~   "
65998|NCT02193464|"~     The purpose of this study is to investigate the incidence and natural course of inflammatory~     bowel disease in the southeastern area of Korea.~   "
65999|NCT02193451|"~     Some men develop difficulty passing urine (voiding) as they age. This may be because an~     enlarged prostate gland (which sits round the base of the bladder) narrows the bladder~     outlet (urethra) or because the bladder becomes less able to contract. Prostate surgery is~     more likely to help symptoms in the first group, while the second group may have no~     improvement after surgery, while being exposed to risk of complications of surgery.~      Invasive urodynamics involves putting a tube (catheter) into the bladder via the penis, and~     another into the rectum, to measure bladder and abdominal pressures while the bladder is~     filled with a sterile fluid. Invasive urodynamics can measure bladder pressures during~     filling and voiding, and bladder outlet obstruction pressures. The procedure is considered~     safe, but some men find it uncomfortable or undignified, and a few develop urine infection~     afterwards. We think that it could be useful to select the men who should and should not~     have surgery. However, no studies have been conducted so far to tell us if this is true:~     UPSTREAM is designed to find out if the invasive tests are worthwhile.~      UPSTREAM is a randomised controlled trial in men who have bothersome difficulty passing~     urine and who are considering having surgery for the symptoms. The group studied will be men~     who continue to be bothered by difficulty passing urine, despite initial treatment such as~     drugs, where symptoms are thought to be due to bladder outlet obstruction. The men will be~     assigned at random to either invasive urodynamic tests as well as the standard tests~     (Invasive urodynamics) or to the routine standard tests (Usual care control arm) alone.~     Routine standard tests include asking men to complete a questionnaire (the International~     Prostate Symptom Score (IPSS)) and a bladder diary, carrying out flow rate testing, and~     checking the urine for infection. Some surgeons also use discretionary tests such as the~     PSA cancer-screening blood test.~      The following men will be invited to participate (inclusion criterion);~      • Men considering undergoing surgery as a treatment option for bothersome urinary symptoms~      Men will not be invited to participate (exclusion criteria) if they:~        -  are unable to pass urine without a catheter (urinary retention)~        -  have a relevant neurological disease, such as a stroke~        -  are undergoing treatment for prostate or bladder cancer~        -  have previously had prostate surgery~        -  are not medically fit for surgery, or are unable to complete outcome assessments~        -  do not consent to be assigned at random to one of the pathways We will compare the two~          methods of investigation by finding out whether the men had similar relief of their~          symptoms, by measuring the change in the prostate symptom score (IPSS) in the two~          groups at 18 months after randomisation.~      We will also look at the following secondary outcomes:~        -  Whether the invasive tests changed the decision for surgery in some of the men (how~          many men had surgery in each of the two groups?)~        -  The cost-effectiveness of the two management pathways~        -  Adverse effects of (a) the tests and (b) the treatments at 6, 12 & 18 months (e.g.~          urinary infection, urinary retention)~        -  Urinary symptoms at 6, 12 & 18 months, using the International Consultation on~          Incontinence Questionnaires (ICIQ) and the Male Lower Urinary Tract Symptoms~          questionnaire (ICIQ-MLUTS)~        -  Quality of life, using the ICIQ-QoL questionnaire~        -  Sexual function, using the ICIQ-MLUTS sex questionnaire~        -  Satisfaction with urodynamic testing, using the ICIQ-UDS-S questionnaire~        -  The maximum urinary flow rate (Qmax) at 18 months~        -  Health outcomes, using the EQ-5D-5L questionnaire~   "
66000|NCT02193438|"~     Human studies have shown that capsaicin, a compound extracted from chilly peppers, can~     stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,~     lipid oxidation, heart rate, etc.).~      The purpose of this study is to measure the impact of ingesting various spicy molecules on a~     set of physiologic parameters compared to a placebo. The molecules were selected for their~     different sensory properties.~      The results of this study will allow us to implement an effective method for measuring the~     impact of ingesting spices on certain body functions (for example, metabolism and autonomic~     nervous system activity). This study will also allow us to identify the beneficial~     properties of eating certain spices.~   "
66001|NCT02193425|"~     Background:~      - Magnetic resonance imaging (MRI) is used to investigate brain function. Researchers want~     to use MRI to better understand the function patterns and connections between brain regions~     in healthy people. This might help people with brain diseases in the future.~      Objectives:~        -  To evaluate MRI methods performed twice on the same day.~        -  To evaluate brain function using positron emission tomography (PET).~      Eligibility:~      - Healthy volunteers at least 18 years old.~      Design:~        -  Visit 1:~        -  Participants will be screened with medical history, physical exam, and interview about~          drug and alcohol use and psychiatric history.~        -  They will give blood and urine samples. Their breath will be tested for alcohol and~          smoking.~        -  Visit 2:~        -  Participants will have urine collected. They will have MRI scans, some while resting,~          some while doing tasks on a computer.~        -  The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie~          on a table that slides in and out of the cylinder, with a coil over their head.~          Participants will get earplugs for loud noises.~        -  Visit 3:~        -  Participants will have urine collected.~        -  A needle will guide a thin plastic tube (catheter) into each arm. The needle will be~          removed, leaving the catheter in the vein.~        -  Participants will then have a PET scan. They will get the chemical 18FDG in the~          catheter. They will lie on a bed that slides in and out of the PET scanner, with a cap~          on their head.~        -  Participants may have tests of memory, attention, concentration, and thinking. They may~          complete interviews, questionnaires, tests on paper or computer, and simple actions.~        -  Participants will wear a device for 1 week between visits to measure activity and~          sleep.~   "
66002|NCT02193412|"~     The purpose of this study is to determine whether the value of analgesia nociception index~     (ANI) is influenced by variations of systemic venous return (cardiac preload) under general~     anaesthesia.~   "
66003|NCT02193399|"~     Research project with patients undergoing allogeneic hematopoietic transplantation in the~     hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main~     objective is to assess the differences in skeletal muscle and functional variables in the~     experimental group underwent a physiotherapy treatment that takes place during the pre-and~     post-transplant period, compared to a control group.~   "
66004|NCT02193386|"~     The study aims to evaluate evidence-based practice behavior in usual care physical therapy~     in Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy~     program based on evidence-based guidelines to the effects of a period of usual care. It is~     hypothesized that supporting therapists by providing a predefined evidence-based~     intervention program, will result in an improved treatment outcome compared to the usual~     care physical therapy.~   "
66005|NCT02193373|"~     The purpose this study is to determine which manual medicine technique or combination of~     techniques has the greatest effect on the natural changes in heart rate.~   "
66006|NCT02193360|"~     The purpose of this study is to determine the initial safety, tolerability and~     pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC~   "
66007|NCT02193347|"~     Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive~     testing from the primary tumor (initial diagnosis) will be offered this treatment study in~     order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy~     (temozolomide).~   "
66014|NCT02193256|"~     The purpose of this study is to examine the effect of varenicline and prazosin on smoking,~     drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an~     FDA approved smoking cessation medication. Some smokers report sleep problems when taking~     varenicline. This study will test whether using prazosin, which is an FDA-approved blood~     pressure medication, in combination with varenicline reduces sleep problems that can be~     associated with using varenicline for smoking cessation. In addition, the study will examine~     the combined effects of these medications on smoking and drinking.~      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and~     insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice~     quit attempt.~      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and~     insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit~     attempt.~   "
66015|NCT02193243|"~     The six-minute walk test is an established submaximal exercise test. Its role in examination~     of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective~     of this study was a comparison of the 6MWT with other established parameters of functional~     capacity, in grown-up patients with GUCH.~   "
66016|NCT02193230|"~     Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.~      The treatment consists in making daily local treatment with topical steroid on inflammatory~     lesions and emollient on the whole body. However, approximately 70% of patients do not~     adhere to therapy.~      Studies have shown that this treatment failure is caused by the complexity of the treatment,~     the time required for its implementation, the cost of treatment, the dosage of the products,~     fear of side effects or misunderstanding about the chronicity of these diseases inflammatory~     conditions of the skin.~      This study aims to evaluate the consideration of patient preference in the choice of~     excipient used for the topical treatment of eczema.~   "
66017|NCT02193217|"~     The purpose of this study is to explore the cardiac pharmacodynamics, safety and~     tolerability of MT-1303 in healthy subjects.~   "
66018|NCT02193204|"~     The purpose of this study is to examine potential stress and immune systems adaptations~     underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and~     social drinkers (SDs) with and without high levels of depressive symptomatology (+dep / -~     dep). Using the investigators experimentally validated guided imagery procedure, the~     investigators propose to examine the response of brain stress and immune systems to~     personalized guided stressful imagery using subjective, physiological and neurobiological~     assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without~     depressive symptomatology.~   "
66019|NCT02193191|"~     The purpose of this research study is to test the safety and efficacy of a drug called~     Plerixafor. Plerixafor is approved by the US FDA for use in increasing blood stem cell~     counts before collection in cancer patients. It is not yet approved for patients with sickle~     cell disease. The investigators want to find out if Plerixafor can be used to increase cell~     counts in patients with sickle cell disease.~   "
66020|NCT02193178|"~     The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better~     than the participants' habitual contact lenses. Further, that a minimum of 80% of those~     enrolled will complete 2 weeks of lens wear with no contraindication to continue.~   "
66021|NCT02193165|"~     The objective of this clinical research study is to assess the efficacy of three oral~     hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and~     a mouthwash in controlling established dental plaque and gingivitis.~   "
66022|NCT02193152|"~     The purpose of this study is to evaluate how participants with advanced non-small cell lung~     cancer (NSCLC) that have certain abnormalities in the pazopanib target genes respond to~     pazopanib treatment.~   "
66023|NCT02193139|"~     This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing~     medication and identify the dose or doses that may effectively reduce axillary sweating in~     hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.~   "
66024|NCT02193126|"~     The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois~     Department of Children and Family Services (DCFS) is implementing a trauma-focused~     intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase~     permanency rates for a target population of children identified as being most at risk of~     long-term foster care.~   "
66025|NCT02193113|"~     This is a Phase 1 study to investigate the safety, tolerability of the novel plasma~     kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first~     step to investigate the hypothesis that plasma kallikrein plays an important role in the~     disease process behind diabetic macular edema in many patients~   "
66026|NCT02193100|"~     To characterize the metabolism of glucose by the leukemic cells in patients with leukemia~     before and after initial chemotherapy.~      To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells~     in leukemic patients.~   "
66027|NCT02193087|"~     The purpose of this study is to evaluate the equivalence of the lyophilized formulation of~     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of~     TDV.~   "
66028|NCT02193074|"~     This study will test the Clinical Efficacy and Safety of IONIS-SMN Rx in patients with~     infantile-onset Spinal Muscular Atrophy.~   "
66046|NCT02192840|"~     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary~     interventions (PCI) and are associated with higher rates of periprocedural complications as~     well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal~     approach to coronary bifurcations treatment is still a subject of debate, especially when~     the side branch is large, not easily accessible and narrowed by a long lesion. One of the~     proposed alternatives are dedicated bifurcation stents (DBS). However, there is large~     scarcity of randomized trials with DBS.~      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two~     intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any~     regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting~     of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®~     (Balton, PL).~   "
66047|NCT02192827|"~     The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.~     two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.~   "
66029|NCT02193061|"~     Assess the immunological behavior of children from 2 months of age that receive one out of~     seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -~     Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)~     versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent~     vaccine), Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent~     vaccine), Group 5 (two doses of pentavalent vaccine followed by a dose of monovalent~     vaccine), Group 6 (one dose of pentavalent vaccine followed by a dose of monovalent vaccine~     and a dose of pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a~     dose of pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.~      Secondary objectives~        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus~          displayed in the seven prevention schedules.~        -  To describe the adverse events temporarily associated with the seven prevention~          schedules.~      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus~     antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages~     and the GMTs induced in subjects that received the routine vaccination schedules with two~     doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).~   "
66030|NCT02193048|"~     The purpose of this study is to prospectively evaluate a scoring system to predict a mild~     course of disease in patients newly diagnosed with Crohn's disease.~   "
66031|NCT02193035|"~     Microparticles are small cell fragments that can induce fat plaques, calcification and~     formation of thrombus. They can be released through multiple stimulations, but also the high~     flow of blood through partially obstructed aortic valves.~      In patients with severely obstructed aortic valves the investigators hypothesize that~     microparticles levels will be elevated and that they will go down after percutaneous~     treatment of the valves.~   "
66032|NCT02193022|"~     Hypothesis:~      Primary hypothesis:~        1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based~          on body weight and height) for 12 weeks is safe with a cure rate of ≥95%.~           Secondary hypothesis:~        2. Development of PKDL in children and adolescent is genetically predisposed and is~          associated with IL-10 & IFN-gamma gene polymorphism causing high and low serum level of~          IL-10 and IFN-gamma respectively.~        3. Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic~          exposure are associated with PKDL.~   "
66033|NCT02193009|"~     The primary aim of this pragmatic randomized-controlled trial was to determine the~     effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption~     (SIPsmartER) when compared to a matched contact physical activity promotion control group~     (MoveMore).~   "
66034|NCT02192996|"~     This pilot trial is designed to investigate the benefits of the use of probiotics in GUT~     microbiota development and/or immunological biomarkers and how this can be related with the~     clinical status of very low birth weight preterms during their first weeks of life at the~     neonatal intensive care unit(NICU).~   "
66035|NCT02192983|"~     This study is designed to assess what is the better neoadjuvant chemotherapy regimen for~     patients with initially unresectable locally advanced gastric cancer.~   "
66036|NCT02192970|"~     The investigators hypothesize that bevacizumab instilled into the vitreous after primary~     retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and~     subsequent retinal re-detachment.~   "
66037|NCT02192957|"~     Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the~     atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart~     rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart~     through electrodes (paddles or skin patches) applied to the outside of the chest wall. The~     shock resets the heart rhythm back to its normal pattern.~      This technique is practiced at many hospitals, including the Heart Institute, and is not~     experimental. However no detailed national or international guidelines exist to assist~     physicians in performing cardioversion. Physicians use a variety of methods. Electrical~     cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose,~     changing the electrode position and applying pressure to the electrodes may improve the~     success rate.~      This study will look at the safety and efficacy of a protocol (step by step method) for~     electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode~     position and the application of pressure to the electrodes the physician will use. The~     individual elements of the protocol (energy dose, electrode position and pressure~     application) are often used by physician in clinical practice but not necessarily in the~     step by step order.~      The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF~     cardioversion protocol'. We think that using this protocol will improve overall~     cardioversion success rates. The results of this study may change usual practice in Canada~     and in other countries.~      All supplies, equipment and medications used in the protocol cardioversion are approved by~     Health Canada.~      We estimate that 389 participants from the University of Ottawa Heart Institute will be~     enrolled in the study over the next 2 years. The results will be compared with a group of~     previous patients.~   "
66038|NCT02192944|"~     Chloroquine and piperaquine are the two most widely used antimalarial drugs ever. Hundreds~     of millions of people have received these drugs. Both are structurally similar and have~     cardiovascular effect. While there are no concerns over the use of chloroquine, regulatory~     authorities have suggested restrictions on the use of piperaquine.~      We have recently completed a series of cross-over clinical and pharmacokinetic evaluations~     of chloroquine, piperaquine, pyronaridine and primaquine in healthy subjects. These studied~     were approved by the ethical committee of FTM. All drugs were well tolerated with no~     clinically significant ECG changes. Four subjects were in two studies. This offers a unique~     opportunity to compare the electrocardiographic effects of chloroquine and piperaquine in~     the same subjects and therefore characterize the concentration-effect relationships, and~     thus relative safety.~      We propose to extend the previous subject study to recruit 16 subjects including those who~     have received either piperaquine or chloroquine in our previous studies so that 20 subjects~     received both drugs for a crossover comparison. The blood sampling schedule and~     electrocardiograms would be exactly the same as previously but would finish at 24 hours.~   "
66048|NCT02192814|"~     EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability~     of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day)~     will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with~     partial-onset seizures.~   "
66049|NCT02192801|"~     Patients with classical bladder exstrophy undergo many surgical interventions with secondary~     urinary tract infections complicating their course. lately primary definitive surgical~     correction of this congenital anomaly has been implemented with satisfactory results.~     Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical~     surgical complications can potentially damage their kidneys in the long-term. therefore we~     decided to evaluate renal function in the long-term in these patients.~   "
66039|NCT02192931|"~     Methamphetamine (MA) addiction is a public health concern that causes substantial harm to~     individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion~     annually. This study proposes to address a critical aspect of this problem: the lack of any~     proven, FDA-approved pharmacological treatments for MA users. The proposal combines an~     intervention designed to improve energy metabolism in the brain, and a neuroimaging~     technique capable of measuring the neurochemicals that represent cerebral bioenergetic~     function. The study will replicate and extend a key neuroimaging finding from the~     investigators recent MA studies: that MA users have decreased phosphocreatine (PCr) levels~     in the brain, compared to healthy volunteers. Phosphocreatine is the substrate reservoir for~     the creatine kinase reaction, which reversibly converts PCr into adenosine triphosphate~     (ATP), the brain's major energy supply, and creatine. Neuronal energy demands are met~     through a shift in reaction equilibrium, which is designed to maintain the concentration of~     ATP constant. Research results from the investigators recent study also showed that female~     MA users have lower brain PCr levels compared to male users. These findings join the~     converging lines of evidence that MA use is associated with mitochondrial dysfunction, i.e.~     deficient energy metabolism, in the brain. Frequently, MA users also experience depression,~     as well as cognitive deficits. Interestingly, both of these entities are also linked to~     mitochondrial dysfunction in the brain.~      The long-term goal of this research program is to define the alterations in brain chemistry~     that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy~     (MRS) neuroimaging to identify rational brain-based treatment targets. Once a~     hypothesis-driven intervention is identified, MRS can then be further employed in treatment~     studies, to verify that target engagement is achieved. The specific aims of this proposal~     are an example of this stepwise scientific process: the nutritional supplement creatine will~     be tested in a randomized, placebo-controlled study of women with MA use disorders, to~     investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.~   "
66040|NCT02192918|"~     The goal of this research is to develop and test the feasibility of an intervention that~     stimulates uptake of healthy alternatives to tanning by providing free access to them for a~     limited time. Free access gives participants a low-risk opportunity to try something new~     that is consistent with their motivations. Free access also allows them to experience the~     reinforcing properties of the alternatives which could prime continued use after the free~     trial period. The objective of the present study is to determine the feasibility and~     short-term efficacy of providing free alternatives to indoor tanners in an effort to nudge~     them to switch from indoor tanning to healthy alternatives.~   "
66041|NCT02192905|"~     The purpose of this research is to develop and test the feasibility of Habit, a weight loss~     mobile application that is designed to coach patients through their weight loss challenges.~     In a pilot randomized trial in 50 obese participants, we will test the feasibility of the~     Smart Coach mobile application when paired with a shortened online-delivered (8-week)~     behavioral weight loss intervention relative to a shortened behavioral weight intervention.~     Feasibility outcomes include frequency and duration of usage of the mobile app and each~     feature, recruitment, and retention. Post-intervention focus groups will discuss the~     feasibility and acceptability of the intervention. The investigators will also do~     exploratory analyses comparing conditions on problem solving skills and weight loss at 8~     weeks, which will inform a subsequent randomized controlled efficacy trial.~   "
66042|NCT02192892|"~     Addition of α-amylase is considered as one of most effective solution to improve energy~     density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of~     porridges will be decreased while keeping dry matter content constant. Potential positive~     impact is to significantly improve efficiency of WFP nutritional programmes targeting~     vulnerable groups suffering from acute malnutrition.~      The acceptance of porridges made with α-amylase is tested compared to porridges made without~     α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based~     on energy intake. The porridges tested consist of fortified blended Supercereal (12- <24~     months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum~     dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a~     commercial porridge, or eeZee bar.~   "
66043|NCT02192879|"~     This study aims to compare the efficacy and safety of three alternative methods of analgesia~     in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia~     (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and~     3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and~     PVB may improve recovery and decrease postoperative pain scores in addition to other~     benefits such earlier return of bowel function and shortened length of hospital stay,~     although some practitioners have voiced concerns about the safety and efficacy of these~     techniques in patients after liver resection who may develop postoperative coagulation~     abnormalities. The investigators plan to enroll a total of 150 patients (adults >/= 18 years~     of age who meet study criteria) scheduled for complex liver resection surgery in this study,~     who will then be randomized into 50 patients per arm of the study (3 total arms).~     Postoperative pain scores will be collected in PACU and throughout the patient's hospital~     stay as well as routine blood tests including complete blood count, coagulation labs~     (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also~     collect additional data prospectively on all patients enrolled in the study; these~     parameters will include age, sex, type of operation performed, length of operation, volume~     of intraoperative blood loss, volume of intraoperative fluid administration including blood~     products, daily postoperative intravenous fluid administration, length of time to first~     feeding, day of epidural catheter removal, length of hospital stay and incidence of major~     postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and~     secondary data points are obtained, the data will undergo rigorous statistical analysis~     using the appropriate statistical techniques to determine the outcomes. The investigators~     propose that epidural and/or paravertebral analgesia may improve recovery times and decrease~     hospital length of stay, which would be beneficial for the patient as well as decrease~     hospital costs. In addition, if better postoperative pain management scores can be achieved~     with epidural or paravertebral analgesia, and no significant prolonged postoperative~     coagulopathy is associated with patients undergoing major hepatic resection surgical~     procedures, these regional analgesia strategies can be considered a safe option for pain~     management in this patient population.~   "
66044|NCT02192866|"~     Food allergies are now a major problem. These experiments involve getting blood from people~     with food allergies and from people without food allergies. The blood collected will be used~     to answer questions and find information about peanut and other food allergies.~      Samples will come from:~        -  People signed up by the investigators at the University of Colorado Denver~        -  University of North Carolina and Massachusetts General Hospital where people have been~          treated for peanut allergies~        -  University of North Carolina, Massachusetts General Hospital, National Jewish Health~          and The Children's Hospital in Denver where people have taken part or will take part in~          clinically indicated oral food challenges.~      Blood and health histories from the University of North Carolina, Massachusetts General~     Hospital, National Jewish Health, and The Children's Hospital will not have personal~     information linked.~      The specific aims of this experiment are:~        1. Come up with a lab test that will predict how bad an allergic reaction will be to~          peanuts.~        2. Find out what part of a peanut causes allergic reactions.~        3. Come up with preventions that can block peanut allergies.~        4. Find the strongest proteins in walnuts.~   "
66045|NCT02192853|"~     The investigators want to estimate both the endothelial and the plasma activity of~     dipeptidyl peptidase 4 during different doses of sitagliptin in healthy subjects and~     patients with type 2 diabetes. Furthermore, the investigators want to investigate whether~     the current clinical dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma~     and the endothelial activity of the enzyme dipeptidyl peptidase 4.~   "
66054|NCT02192736|"~     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived~     mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and~     useful procedure for inducing improvements in pulmonary function and quality of life in~     asthma patients.~   "
66055|NCT02192723|"~     The purpose of this study is to compare the efficacy and side effects of 6 commonly used~     antipsychotic drugs in the treatment of schizophrenia in a Chinese population.~   "
66056|NCT02192710|"~     Rationale:~      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug~     premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so~     coordination between departments and operating room, exposed to the risks of side effects~     and failure and this variability action. Alternative means were evaluated, such as the~     presence of parents during anaesthetic mask induction, distraction by clowns, hypnosis or~     video games.~      Electronic tabs are small devices; light, easy to use with age-specific and interactive~     programs. Our hypothesis is that these electronic tabs are more effective in reducing~     anxiety and distract children compare to preoperative medication.~      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10~     years old programmed for a short term and low level of pain outpatient surgery. My pass~     score will be measured when arriving at the hospital, at the time of the separation with the~     parents, at the time of the anaesthetic mask induction and after the surgery.~      118 patients will be randomized as follows :~        -  Arm 1 : Hypnovel® (midazolam)~        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the~          Lyon area.~   "
66057|NCT02192697|"~     Purpose of the study is to determine the following in patients with non-small cell lung~     cancer (NSCLC) harboring EGFR activating mutations.~        -  the safety and tolerability of ASP8273.~        -  the pharmacokinetics (PK) of ASP8273.~        -  the antitumor activity of ASP8273.~   "
66058|NCT02192684|"~     Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and~     public health burdens in the United States. That these diseases appear to co-exist and~     together increase one's risk of cardiovascular disease renders investigation into their~     shared pathophysiology even more urgent. Investigators will assess prevalence of insulin~     resistance, a precursor to diabetes, among overweight patients with OSA. Among those at~     highest risk of diabetes, investigators will randomize participants to pioglitazone or~     placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or~     insulin secretion. In a separate intervention, investigators will evaluate the~     cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in~     patients with OSA. Investigators will also study subjects from the community without known~     sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea~     using clinical screening questionnaires.~   "
66059|NCT02192671|"~     The purpose of the investigators' study is to prospectively compare the safety and efficacy~     of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients~     with portal hypertension.~   "
66060|NCT02192658|"~     According to the recent World Report on Disability, around 15% of the world population lives~     with a disability and 80% of people with disabilities (PWD) live in developing countries.~     More and more evidence show that PWD are more likely to be poor, vulnerable to physical and~     sexual violence, and to have less access to education. Therefore, PWD are likely to have an~     increased risk for HIV infection, potentially being a key population in regard to this~     epidemic.~      The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the~     Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV~     is still very limited. As a result, PWD are usually overlooked by National AIDS Control~     Programmes and few projects specifically targeting them have been developed.~      Recognizing the need for appropriate and reliable data to help protect the rights of PWD and~     achieve a better inclusion of disability in National AIDS Control Programmes, the Institute~     of Research for Development (IRD), the Institut de Formation et Recherche Demographique~     (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative~     and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina~     Faso, in order to define if this vulnerable population is also a Key Population in relation~     to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and~     qualitative methods). Quantitative data are collected only in Cameroon.~      Only the quantitative study is described here.~   "
66061|NCT02192645|"~     The purpose of this study is to determine whether Sanfujiu is effective and safe in the~     treatment of persistent allergic rhinitis.~   "
66062|NCT02192632|"~     The purpose of this study is to evaluate the efficacy and tolerability of this combination~     gel compared with BPO monotherapy in Korean patients, and test clinical practicability of~     dermatologists' educational demonstration for how to apply this gel in reducing~     uncomfortable irritations.~   "
66063|NCT02192619|"~     The registry aims to document epidemiologic data, treatment and long-term outcome as well as~     quality of life of patients with APL. Additionally, a biobanking project for further~     translational studies is integrated.~      Prospective population-based non-interventional and non-randomized multicenter registry.~   "
66064|NCT02192606|"~     The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal~     cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice~     laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial~     comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by~     residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be~     randomized to either 2D versus 3D.~   "
66065|NCT02192593|"~     This is a randomized controlled trial, examining the effects of a computerized,~     internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a~     schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).~     Participants are randomized to one of two conditions: either to receive the 10-session~     computer-based program on a weekly basis, or to their usual care at their mental health~     clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It~     is hypothesized that the participants who participate in the CBT program will have~     significant improvements in the severity of their auditory hallucinations, as well as their~     associated distress, compared to the participants receiving usual care.~   "
66066|NCT02192580|"~     Urinary tract infections (UTI) are a common and important clinical problem in~     childhood.Upper urinary tract infections (ie, acute pyelonephritis) may lead to renal~     scarring, hypertension, and end-stage renal disease.Pathogenesis of acute pyelonephritis~     (APN) is associated with urinary tract anatomy and function, bacterial virulence factors,~     the host innate immune system and production of free radicals. Oxygen-free radicals and~     oxidative stress play a role in renal scar formation after an APN. Oxygen-free radical~     scavengers and antioxidants can reduce tissue damage and renal scaring during acute~     pyelonephritis.we want to publish a study that indicates that antioxidant therapy with~     omega-3 given to children with pyelonephritis may indeed lower the risk for renal scarring.~      Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is~     a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to~     antibiotic on preventing renal scaring after acute pyelonephritis in children. This~     randomized clinical trial on 60 patients in 2 groups (intervention & control) is~     conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings,~     and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute~     pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder,~     systemic hypertension, obstructive uropathy and high grade vesicouretera are~     excluded.Patients in Intervention group are administered omega-3 based on body weight in~     divided doses in addition to antibiotic regimens and patients in control group received~     antibiotic regimens without omega-3. Primary outcome is the development of renal scar by~     doing DMSA renal scan on the 7th day of admission and four to six months after the~     intervention and compared between groups.Also,measurement of urinary biomarker of acute~     kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of~     subsequent scarring in both groups will be done . Secondary outcome is the incidence and~     severity of renal scarring after pyelonephritis and response to treatment between two~     groups.~   "
66067|NCT02192567|"~     This is an open-label, sequential dose escalation and expansion study to evaluate the~     safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant~     tumors.~   "
66068|NCT02192554|"~     To follow-up on the safety of subjects who were previously treated in a double-blind trial~     of brexpiprazole.~   "
66069|NCT02192541|"~     Background:~      - Some people have cancers that don t respond to standard treatments. In these cases,~     doctors may try to use drugs to slow the growth of the cancer.~      Objectives:~      - To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept.~      Eligibility:~      - Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and~     sarcomas.~      Design:~        -  Participants will be screened with medical history, blood tests, and scans to measure~          their tumors.~        -  Participants will have one or two eye exams, with dilating eye drops.~        -  Participants will get the study drugs at the clinic as an infusion in a vein.~          Ganetespib will be given once a week on the same day for 3 weeks in a row, followed by~          a 1-week rest period. Ziv-aflibercept will be given once every other week. The drugs~          will be given in 28-day cycles.~        -  Participants may have a small piece of their tumor collected once or twice. This is~          done using a small needle during computed tomography (CT), magnetic resonance imaging~          (MRI), or ultrasound scan.~        -  Participants will have their blood pressure checked at each visit. They will check it~          at home every day of the study.~        -  Participants may have one or more whole-body PET scans with 89Zr-panitumumab. A small~          amount of a radioactive chemical will be injected through a tube in an arm.~          Participants will lie on a bed that slides in and out of the donut-shaped PET scanner.~          They will have small amounts of blood drawn.~        -  Participants may stay in the study as long as they are tolerating the drugs and their~          tumor is not getting worse.~   "
66070|NCT02192528|"~     We will use a retrospective data analysis to evaluate the association of the two vitamin D~     metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac~     surgical patients. The occurrence of several postoperative adverse events such as myocardial~     infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from~     cardiac surgery to discharge. In addition, we will assess the association of the two vitamin~     D metaboolites with the duration of mechanical ventilatory support and intensive care unit~     stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed~     according to vitamin D metabolite levels.~   "
66071|NCT02192515|"~     The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy~     Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,~     placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a~     single center, randomized, open-label study that consists of two sequential two-way~     crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized~     to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study~     drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group~     (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized~     to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study~     drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In~     cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)~     to receive study drug in the sequence shown below.~      Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose =>~     XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d.,~     multiple dose (fed)~      Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) =>~     XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d.,~     multiple doses (fasted)~   "
66089|NCT02192268|"~     The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources~     may have positive effects in this population of children with acute respiratory illness.~      Thinking about this physical and physiological issue and due to the absence of a study that~     has evaluated the effectiveness of these instruments in patients with pneumonia, the~     objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in~     children hospitalized for community-acquired pneumonia.~   "
66090|NCT02192255|"~     This multisite pragmatic clinical trial was designed to assess the effectiveness of a single~     scripted telephone call to diabetes patients who (a) were currently above recommended~     clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed~     a new medication for that specific clinical domain. The goals of the intervention were to~     improve primary adherence and persistence to the newly prescribed medication and to improve~     control of glucose, blood pressure, and lipids.~   "
66091|NCT02192242|"~     The pathophysiology of acute ischemic pain is not well established. The aim of the present~     study was to investigate acute ischemic pain in humans with a view to establish a scientific~     model to perform future studies. The investigators examined whether peripheral nerve damage~     and acute inflammation occur during short episodes of acute ischemia.~   "
66072|NCT02192502|"~     The purpose of this study is to evaluate the safety of a standard volume replacement called~     HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an~     alternative to pure fluid replacement solutions that are associated with problems after~     surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4~     (Voluven) will be evaluated by examining its effects on kidney function, and coagulation~     parameters and platelet (part of the blood that help it clot) function.~      Participants will be randomized (like flipping a coin) to receive one of two possible volume~     replacements during surgery, if fluid volume decreases enough to need replacement with one~     of the fluids. The two possible volume replacements are Voluven (a starch-containing fluid)~     or human albumin 5% (a protein-containing solution).~      To examine kidney function, urine will be-sampled when the participant is put under general~     anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours~     after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established~     line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24~     hours after surgery and every morning during the participants postoperative ICU stay.~      Additionally, health and recovery information will be recorded from the participant's~     medical record. We will phone participants around 90 days and one year after surgery to ask~     a few questions about one's health and recovery. We will also record blood sample analysis~     results from follow up appointments within the first year after surgery. If this analysis is~     not conducted at the Cleveland Clinic, with permission, we will obtain the results from a~     treating physician.~   "
66073|NCT02192489|"~     This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy~     of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.~   "
66074|NCT02192476|"~     california tri-pull taping (CTPT) method might be effective in reducing shoulder~     subluxation, pain, and improving active flexion range (AFLXN) range of motion, and~     functional recovery after stroke.~   "
66075|NCT02192463|"~     Study to determine the relative bioavailability of different oral Viramune Extended Release~     (ER) formulations compared to Viramune® Immediate Release (IR) tablet~   "
66076|NCT02192450|"~     The purpose of this study is to determine whether insulin degludec compared to insulin~     glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the~     greatest potential benefit from optimised insulin treatment, which are patients with type 1~     diabetes and high risk of nocturnal severe hypoglycaemia.~   "
66077|NCT02192437|"~     Studies in laboratory models indicate that dietary methionine restriction (MR) enhances~     longevity and produces short- and long-term metabolic changes that are consistent with a~     healthy lifespan. The present study was designed to establish levels of dietary methionine~     or methionine and cysteine that induce physiological changes in healthy adults like those~     observed in rodent studies .~   "
66078|NCT02192424|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a randomized controlled trial to determine whether~     intermittent intensive insulin therapy is an effective therapeutic strategy that can~     preserve pancreatic beta-cell function and maintain glycemic control early in the course of~     type 2 diabetes.~   "
66079|NCT02192411|"~     Endovenous laser treatment is a minimally invasive procedure that has been shown to be a~     safe and effective treatment for varicose veins. Essential to the successful ablation of~     refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. One of the~     components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While~     lidocaine can be used safely as long as serum concentrations remain low, its use carries the~     risk of lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is~     desirable to use the minimum effective concentration of lidocaine needed to manage pain~     during a procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in~     tumescent anesthesia will function as well as the standard dose for pain management in~     endovenous laser treatments. If we find that this is the case, we will be able to reduce the~     risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while~     maintaining their comfort throughout the procedure. This will be achieved through a direct~     comparison of intra- and post-operative pain for patients randomized to receive either the ¼~     tumescent lidocaine concentration or the standard lidocaine concentration.~   "
66080|NCT02192398|"~     Combination of guanfacine with opioid medication as a standard treatment for chronic pain.~   "
66081|NCT02192372|"~     Prevention of contrast induced nephropathy after interventional cardiologic procedures~     deserves close interest because of its association with prolonged hospitalization, increased~     cost and increased in hospital and long term mortality rates. An observational prospective~     cohort study was designed to determine whether metabolic syndrome predicts the development~     of contrast induced nephropathy after elective percutaneous coronary intervention.~   "
66082|NCT02192359|"~     This phase I trial studies the side effects and best dose of carboxylesterase-expressing~     allogeneic neural stem cells when given together with irinotecan hydrochloride in treating~     patients with high-grade gliomas that have come back. Placing genetically modified neural~     stem cells into brain tumor cells may make the tumor more sensitive to irinotecan~     hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural~     stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.~   "
66083|NCT02192346|"~     The goal of this study is to find the highest dose of α-TEA that can be given to patients~     safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in~     patients' blood.~      Additional goals of this study are to monitor the effect on tumors, to check for specific~     immune cells circulating in the blood, and to see if there are certain features of tumors~     that make it possible to predict the response to α-TEA.~   "
66084|NCT02192333|"~     This randomized clinical trial studies survivorship care in reducing symptoms in young adult~     cancer survivors. Survivorship care programs that identify the needs of young adult cancer~     survivors and ways to support them through the years after treatment may help reduce~     symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult~     cancer survivors.~   "
66092|NCT02192229|"~     Abstract:~      The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of~     the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of~     population with vitamin D deficiency.~      A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be~     conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years~     who attend the rehabilitation clinics at Jordan University Hospital .Participants who met~     the inclusion criteria will be asked to sign an informed witnessed consent form. Results~     obtained are expected to assess the safety and efficacy of the dose regimen used in this~     study as per Biodal SmPC. This study will also contribute to the global body of knowledge in~     this field. The major findings generated from this study could open certain avenues for~     further research through the association of the status of vitamin D in serum .~   "
66093|NCT02192216|"~     Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma~     patients. The Danish nation-wide training and rehabilitation offer 'Body & Cancer' offers~     intensive resistance and endurance training to all Danish cancer patients receiving~     chemotherapy with the aim of reducing treatment-related fatigue and physical impairments,~     but the potential of the training to preserve or improve muscle mass is uninvestigated.~      Furthermore, the underlying biological mechanisms of treatment and/or exercise induced~     changes in muscle mass in cancer patients remains uninvestigated.~      Thus, the primary purpose of the present study is to investigate changes in body composition~     during chemotherapy and after resistance and aerobic training combined with protein~     supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to~     investigate the underlying biological mechanisms of muscle mass regulation in biopsies~     obtained before and after a control period as well as after 10 weeks of exercise, both~     during chemotherapy.~      We hypothesize that 10 weeks exercise will improve muscle mass and body composition in~     cancer patients during chemotherapy as compared to a control period during chemotherapy~     alone.~   "
66094|NCT02192203|"~     This research study is being carried out to determine the possibility that a new medication~     causes allergic reactions. This new medication contains two active ingredients (diclofenac~     and menthol) together in a gel and is being developed to treat mild to moderate pain and~     inflammation, such as acute sport injuries, and sprains and strains. Approximately 240~     participants will have the medication (gel) applied to the skin on a small area of the upper~     back for approximately 48-hour or 72-hour periods over the course of six weeks.~     Participation in this research study is voluntary, requiring participants to visit the study~     clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or~     trained staff members will examine the amount of redness, swelling, and other signs of~     irritation (if any) of the skin where the medication (gel) was applied.~   "
66095|NCT02192190|"~     The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.~     The study drugs will be given as an injection under the skin and as an oral capsule. The~     study will last about 28 weeks for each participant.~   "
66096|NCT02192177|"~     Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially~     late second and third trimester. We aimed to investigate the role of apoptosis in~     etiopathogenesis of obstetric cholestasis.~   "
66097|NCT02192164|"~     Pilot observational study to describe the relationship between the smoking status of a~     psoriatic individual and the success of etanercept therapy in psoriasis treatment~   "
66098|NCT02192151|"~     To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability~     of PHN131 in healthy volunteers~   "
66099|NCT02192138|"~     Research project objectives.~      The project includes eight research hypotheses and eight corresponding study objectives. The~     most relevant objectives are:~        -  Analysis of lung function and gas exchange parameters in relation to the removed~          pleural fluid volume and intrapleural pressure changes.~        -  Evaluation of changes in lung and chest wall compliance and related changes in work of~          breathing during therapeutic thoracentesis and pleural fluid withdrawal.~        -  Study of the relationship between intrapleural pressure changes and cardiac function~          assessed by echocardiography and alterations in serum natriuretic peptide A and B~          concentration.~        -  Comparative analysis of the reliability of the volume-pressure curve slope prediction~          based on different variables measured before thoracentesis and real measurements of~          ventilation and intrapleural pressure during thoracentesis.~           2. Research methodology The study will be performed in 60 patients with pleural~          effusion planned for therapeutic thoracentesis.~      Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity~     (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic~     peptide concentration.~      Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory~     rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous~     measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to~     enable fluid drainage and intrapleural pressure measurement after completion of~     thoracentesis.~      Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be~     repeated in specific time points and compared in two subgroups (active physiotherapy to~     improve lung re-expansion and passive lung re-expansion).~      Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the~     catheter will be removed.~      Analysis.Signal analysis and visual multidimensional analysis performed with the use of own~     computer programs will be the first step of the analysis. The identified relationships~     between the analyzed parameters should allow to form physiological, medical, and statistical~     hypotheses, as well to verify the analysis of previously obtained data .~      Expected impact of the research project The study results will allow to define lung~     function, blood gases and cardiovascular function in relation to changes in intrapleural~     pressure. Some of these correlations had not been previously investigated. Our results may~     influence management standards in patients who require therapeutic thoracentesis.~   "
66100|NCT02192125|"~     The study examines the possible application of the rehabilitation platform REWIRE.~   "
66101|NCT02192112|"~     Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during~     XLIF has been demonstrated, it is hypothesized that more information may be gathered if a~     greater section of the motor neural pathway was monitored (i.e., stimulation above the~     surgical site and recording the subsequent muscle response in the lower limbs). Currently,~     there has not been demonstrated a practical method of stimulating the lumbosacral nerve~     roots locally, but well-above the surgical site in this fashion.~      This protocol is intended to evaluate the feasibility and reproducibility of using surface~     stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and~     record responses from the relevant innervated muscle groups of the lower limbs.~   "
66102|NCT02192099|"~     Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in~     GLYX13-C-202.~   "
66103|NCT02192086|"~     The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid~     administration algorithm on early graft function in patients undergoing kidney~     transplantation. Fluid administration has increasingly been scrutinized within anesthesia~     related literature as an area for improvement, and the imbalance present between estimated~     blood loss and total fluid administered for kidney transplants must be amongst the highest~     case categories. Considering the patients are anuric for the majority of the procedure,~     unguided administration of multiple liters of crystalloid appears antiquated.~   "
66104|NCT02192073|"~     Biceps pathology typically includes pain in the anterior shoulder that is reproduced with~     provocative maneuvers. However, optimal treatment of patient with this diagnosis is not~     clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting~     then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral~     discomfort from spasms, many surgeons perform tenodesis. There are various techniques for~     tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an~     incision higher in the shoulder) versus subpectoral fixation (surgery which involves making~     an incision lower in the shoulder).~      Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or~     open subpectoral biceps tenodesis results in better function.~   "
66105|NCT02192060|"~     The aim of the study is to compare the effect of a suspension containing Triclosan in~     dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial~     subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).~   "
66106|NCT02192047|"~     The investigators hypothesized that there will be a significant difference between the~     effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on~     cardiovascular disease, inflammation, insulin resistance and obesity.~   "
66107|NCT02192034|"~     Colorectal cancer is the second leading cause of death from cancer in the United States. Two~     major barriers to successful colorectal cancer screening are appointment keeping and proper~     bowel preparation. The purpose of this study is to test the efficacy of a patient navigation~     program to increase colorectal cancer screening at Rush University Medical Center. The~     investigators hypothesize that colorectal cancer screening will be improved for subjects who~     utilize a patient navigator.~   "
66108|NCT02192021|"~     The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will~     kill tumor cells locally and alter the tumor microenvironment to induce durable systemic~     tumor-specific immunity.~      The purpose of this study is to test a new method of experimental treatment for CTCL, using~     small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens~     of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy~     agent. The overall goal of this study is to test the safety and effectiveness of these~     patches. We also want to determine which micro-dose of the drug is the best to achieve the~     best response. To make sure that we observe the effects of the very low dose of the drug and~     not the MNA patch itself, we will also use a placebo (a patch without drug in some patients)~     in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where~     the patches are applied. Once the best dose is determined for use in the patch, we will also~     begin to look at how well the patches work in clearing the skin.~   "
66109|NCT02192008|"~     Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a~     bacteria called Salmonella enterica. After ingesting contaminated food or drink, the~     Salmonellae travel first to the gut, then the bloodstream, from where they can infect other~     parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of~     antibiotic resistance, this treatment is becoming less effective.~      Two Salmonella variants, Typhi and Paratyphi, cause over 30 million cases of enteric fever~     and more than 200,000 deaths per year, mostly in developing countries. While improved~     hygiene and sanitation should eventually eliminate enteric fever, reduction of the disease~     burden in the medium term is achievable through effective vaccination.~      Vaccines likely to be available for mass vaccination are effective only against those~     Salmonella strains that bear the Vi polysaccharide capsule protein. Strains that do not have~     these capsule proteins, or have no capsule, will not be affected by vaccination and could~     'fill' the space vacated by the capsulated strains. Indeed, enteric fever caused by S.~     Paratyphi A which does not carry the Vi protein, has risen during the past decade and~     accounts for more than half of all cases in some areas. Thus it is important that effective~     vaccines are available to protect against infection by both capsulated and noncapsulated~     Salmonella enterica. To develop such vaccines, we need a complete understanding of the human~     immune response to both types, including the contribution of immunity in the gut and the~     bloodstream, immune response to bacterial surface proteins, and the role of antibodies. How~     much cross-protection there is between the types of typhoidal Salmonellae after natural~     infection or vaccination is not known, but this is critical to vaccine development.~      This project aims to fill in the knowledge gaps highlighted, by fully characterising the~     infection process and immune response in enteric fever.~   "
66110|NCT02191995|"~     Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.~   "
66111|NCT02191982|"~     This study will look at the impact of a self-directed walking program on post-chemotherapy~     survivors experiencing fatigue. It is hypothesized that the walking program will help lessen~     fatigue.~   "
66112|NCT02191969|"~     This study will see if patient who undergo a physical activity intervention called Walk With~     Ease report experiencing less fatigue and a higher quality of life during chemotherapy for~     colorectal cancer than those who do not participate in this intervention.~   "
66113|NCT02191956|"~     This study aims to the test the efficacy and cost effectiveness of new service delivery~     methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent~     Training (BPT), for early onset disruptive behavior disorders.~   "
66114|NCT02191943|"~     The aim of the planned in-vivo trial is to investigate the effectiveness of the caries~     infiltration technique for the repression of caries progression.~      Within the framework of this investigation it is intended that the hypothesis to be~     substantiated is that carious cavities, which have been treated with the caries infiltration~     technique, exhibit significantly reduced radiological progression than those cavities that~     have been treated using standard preventive treatments.~      In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at~     each institution are to be treated with both, the infiltration technique and using~     conventional fluoridation treatment in different sides of the mouth (split-mouth design).~      The anticipated result of this trial shall deliver information on the long-term~     effectiveness of caries infiltration to prevent the progression of existing approximal~     carious lesions, and thereby enable an improvement in caries prevention within the scope of~     dental treatment.~   "
66115|NCT02191930|"~     The purpose of this trial is to determine~        1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or~          PR in the centrally reviewed restaging after six cycles of chemotherapy~        2. Progression-free survival (PFS) 3 years after registration~   "
66116|NCT02191917|"~     Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will~     test respiratory muscle strength initially and again after 24 weeks in subjects treated or~     not treated with BMN 701 .~   "
66129|NCT02191761|"~     This is an open-label, multi-center, dose escalation study in adult subjects with advanced~     colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety,~     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered~     orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be~     enrolled.~   "
66117|NCT02191904|"~     To ensure minimal cervical motion during the intubation of trauma patients is important for~     the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.~      Intubation is required to secure the airway in patient during an anesthesia management or a~     mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for~     intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,~     various types of laryngoscopes have been developed to be used for in case of difficult~     intubations, the intubation of the patients with head and neck trauma, or the intubation~     attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly~     developed laryngoscopes, integrated with an optical view system.~      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently~     introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type~     laryngoscopes, having an angle of 46° at the end of blade and including a camera system that~     magnifies the image.~      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed~     type of laryngoscope, including optical imaging system. There is a channel on the device for~     the placement of the endotracheal tube. Endotracheal tube is inserted into the channel~     before the laryngoscopy. It has been reported that Airtraq is a novel single use~     laryngoscope which provides glottis display without any deviation in the normal position of~     the oral, pharyngeal or the tracheal axes.~      In the literature, there are many studies comparing the effects of these newly developed~     laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.~     However, in these studies, individual vertebral motion was reported during the placement of~     the tube, while the angulation of the head and neck and the difficulty of the intubations~     were not clear.~      In this study our first hypothesis was cervical motion during endotracheal intubation in~     Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one~     was the endotracheal intubation time is similar to the Macintosh that is used more often.~   "
66118|NCT02191891|"~     Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose~     (RP2D) of BI836845 in combination with afatinib in patients with non-small cell lung cancer~     with progression following prior treatment (EGFR TKI or platinum-based chemotherapy).~      Part B: To evaluate the early anti-tumour activity of BI836845 in combination with afatinib~     in patients with EGFR mutant non-small cell lung cancer with progression following prior~     irreversible EGFR TKIs.~      Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with~     afatinib in patients with non-small cell lung cancer~   "
66119|NCT02191878|"~     This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2~     expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor~     activity of intravenous TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC).~      This study is being done to:~        -  Test the safety and tolerability of TKM-080301 in subjects with advanced hepatocellular~          carcinoma~        -  Find the highest dose of TKM-080301 that can be given without causing side effects,~          called the maximum tolerated dose (MTD).~        -  Provide a preliminary assessment of anti-tumor activity of TKM-080301~   "
66120|NCT02191865|"~     The primary objective of this study is to investigate the effect of mild (Child-Pugh A,~     score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the~     pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group~     with normal hepatic function following oral administration of nintedanib as single dose.~   "
66121|NCT02191852|"~     Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid~     reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)~     and in plasma, compared to baseline values; furthermore to detect the quantitative~     enrichment of individual antioxidant compounds contained in the product and to investigate~     whether or not some of them accumulate in target tissues such as skin, BMCs and plasma~   "
66122|NCT02191839|"~     Protocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo~     controlled study.~      STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the~     Department of Cardiothoracic Surgery, Soroka University Medical Center.~      OBJECTIVE To evaluate anti-inflammatory effects, effects on organ function preservation, and~     postoperative blood loss reduction following AAT-1 administration in patients undergoing~     CABG with CPB.~      PRIMARY ENDPOINT Postoperative organ function preservation and blood loss following~     preoperative single-dose AAT-1 administration.~      SAMPLE SIZE CONSIDERATIONS A cohort of 20 patients will be recruited. Patients will be~     randomized to receive either AAT-1 or placebo prior to surgery. Whereas this is a proof of~     concept pilot study, statistical significance is not the primary objective.~      INCLUSION CRITERIA 1. The study population will comprise patients between 40 and 70 years of~     age, irrespective of gender, at low or intermediate operative risk (calculated Logistic~     Euroscore stratification of 5% or less), assigned to elective CABG with CPB. Recruitment~     depending on patients informed consent.~      EXCLUSION CRITERIA Co-existing conditions including:~        1. Coagulation abnormalities~        2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of~          less than 60% of predicted.~        3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,~        4. Abnormal liver function tests~        5. Uncontrolled diabetes mellitus,~        6. Severe peripheral vascular disease~        7. Prior cerebrovascular neurological event.~        8. Abnormal left or right ventricular function.~        9. Treatment with warfarin or thienopyridine class of anti platelet agents.~   "
66123|NCT02191826|"~     Clinical proof of concept study to evaluate SOM0226 efficacy in TTR Amyloidosis.~   "
66124|NCT02191813|"~     Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by~     Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1~     expression) activated by UV radiation~   "
66125|NCT02190760|"~     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the~     duration of a block. The aim of this study is to determine whether this a systemic or local~     effect.~   "
66126|NCT02190747|"~     Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life~     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza~     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to~     cumulative loss of function and disability. Mouse models of FOP have demonstrated the~     ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification~     (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR~     gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.~   "
66127|NCT02191787|"~     Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers~     and the optimal time for blood sampling~   "
66128|NCT02191774|"~     Medical abortion performed in the womens home has shown to be safe and acceptable up to 9~     weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally~     effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of~     gestation.~   "
66130|NCT02191748|"~     Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to~     depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing~     not only changes in the color of skin, but also significant cosmetic concerns and quality of~     life issues. Current treatment modalities, which include topical corticosteroids,~     intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably~     effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory~     to treatment. There is a need for new, effective modalities to treat patients with otherwise~     refractory vitiligo.~      Needling is an office based procedure that theoretically transposes healthy, pigmented skin~     cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of~     needling as a novel treatment for vitiligo had promising results but were limited by small~     sample size and subjective results.~      The proposed randomized control trial (RCT) will further investigate the use of needling to~     treat vitiligo. It differs from the previous studies in that it seeks to identify the cause~     of clinical benefit by comparing needling alone to needling with corticosteroid, examines a~     larger number of patients, and quantifies improvement using confocal microscopy. Confocal~     microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has~     been used in the past to diagnose cutaneous pigmentary conditions. This study would be the~     first RCT of needling in vitiligo to use an objective measure to quantify results, thus has~     the potential to establish needling as a novel, effective treatment for vitiligo and to~     evaluate the utility of CFM for monitoring response to treatment.~   "
66131|NCT02191735|"~     This clinical investigation is designed to demonstrate the performance characteristics of~     the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the~     point-of-care when compared to the results for the same samples analyzed on the RAMP®~     Reader.~   "
66132|NCT02191722|"~     We believe, that the results of this study will show that children learn from the comic book~     about their disease, and are now more aware and less frightened about it, and increase their~     compliance.~   "
66133|NCT02191709|"~     Study to investigate the relative bioavailability of orally administered dextromethorphan~     syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female~     subjects who are extensive metabolisers for CYP 2D6~   "
66134|NCT02191696|"~     The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the~     IMED-4~   "
66135|NCT02191683|"~     Study Hypotheses:~        1. Anaemia, which is frequent before conception as well as during early pregnancy, affects~          metabolism and foetal growth trajectories, influencing the risk of NCDs in the~          offspring.~        2. Anaemia from conception till end of 2nd trimester is most detrimental for foetal and~          newborns' health, compared to 3rd trimester anaemia.~        3. Anaemia from conception till end of 2nd trimester affects foetal and newborns health~          through poor placental development reflected in increased villous branching and changed~          umbilical and uterine blood flow.~        4. Anaemia in early pregnancy disrupts the vascular endothelial growth factor A~          (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor~          (IGF) axis resulting in poor placental development, and poor health of newborns. This~          may be reflected in specific methylation patterns.~        5. Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic~          mechanisms, including changes in DNA methylation patterns.~   "
66136|NCT02191670|"~     Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation.~     Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue~     plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction~     in usual routine treatment after market launch~   "
66137|NCT02191657|"~     The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of~     different dosages of deferiprone in subjects with or without HIV infection.~   "
66138|NCT02191644|"~     This study examined whether dietary-induced reductions in lipoprotein-associated~     phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma~     affected metabolic profiles in PBMCs and plasma.~   "
66139|NCT02191631|"~     The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17~     years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either~     ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment~     condition.~   "
66140|NCT02191618|"~     The study is a prospective, multicenter single-arm cohort. Patients with wide neck~     bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular~     treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB.~     The primary effectiveness outcome of the study is the likelihood of complete intracranial~     aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.~   "
66141|NCT02191605|"~     Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal~     exposure to marijuana can have lasting negative effects. However, current answers to this~     problem are failing to reach most women who use marijuana while pregnant. This project will~     develop and begin testing two technology-based, highly practical interventions that could~     reduce the number of children who are prenatally exposed to marijuana.~   "
66142|NCT02191592|"~     The purpose of this research study is to test a new way of measuring the severity of~     tinnitus using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will~     compare the relationship with this tool with another widely used questionnaire. Previous~     studies we have done suggest there are different patterns of tinnitus bother; we plan to~     explore how often these patterns occur, and how many patterns of tinnitus bother there are.~     And lastly we want to test how reliable this type of testing is for measuring the amount of~     bother people experience from their tinnitus.~      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.~      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of~     bother individuals have from tinnitus.~   "
66143|NCT02191579|"~     This study will evaluate the efficacy, safety and tolerability of prophylactic~     (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults~     with chronic migraine.~   "
66144|NCT02191566|"~     After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given~     chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and~     oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was~     administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).~   "
66145|NCT02191553|"~     Mindfulness can be considered as a family of complex attentional and emotional regulation~     strategies that promote the cultivation of well-being and emotional balance. The practice of~     mindfulness produces the development of a consciousness that unfolds moment to moment, open~     and unprejudiced in the present moment, here and now. Despite its extensive benefits, the~     practice of mindfulness requires a significant commitment in time and effort, which limits~     the potential for its dissemination. The studies to narrow the differential effects of the~     various exercises based on mindfulness, will further enhance their effectiveness and they~     can guide the practice sequence according to user needs. In this paper we will research~     mindfulness electroencephalographic correlates of as four different exercise programs~     included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on~     mindfulness (MBSR) as well as its effect on several psychological variables.~   "
66146|NCT02191540|"~     Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of~     Abnoba viscum F 20mg in patients with malignant pleural effusion~   "
66147|NCT02191527|"~     The general goal of the proposed study is to evaluate the cost-effectiveness of POC~     technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4~     counting performed within MCH services to improve maternal and infant health.~      A prospective, quasi-experimental study will be done in Cabo Delgado province, where health~     facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and~     infant health will be measured.~   "
66148|NCT02191514|"~     Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is~     available, but only 12% of stroke patients receive it.~      The treatment is only available within a time frame of 4,5 hours from symptom onset, thus~     the Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.~      The aim of this study is:~        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the~          EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast~          and correct EMS-response.~        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,~          create a baseline for future comparison and generate explorative hypotheses for~          forthcoming interventions.~      The overall aim of this study is, to ensure the best possible prehospital care for all~     stroke patients. The study will determine, if the EMD is at a high and international level~     in regards to stroke recognition, and if there is a potential to decrease on-scene time.~     This will serve as future comparison and have an effect on the structure and future~     education in the prehospital services, and potentially improve the outcome after acute~     ischemic stroke.~   "
66149|NCT02191501|"~     The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing~     of the gastric pylorus to delay gastric emptying and treat obesity.~   "
66150|NCT02191488|"~     Removing a tumor from a patients brain is hard to do because, very often, brain tumors do~     not have boundaries that are easy for the patients surgeon to find. In many cases, the~     surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove~     most of the patients tumor by looking at the MRI images that were taken of the patients~     brain before surgery. However, the surgeon does not have any good way to tell if the entire~     tumor has been removed or not. Removing the entire tumor is very important because leaving~     tumor behind may allow it to grow back which could decrease the chances of survival.~   "
66151|NCT02191475|"~     Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic~     therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®)~     scheme, compared with the classical scheme, evaluate its efficacy, safety index.~   "
66152|NCT02191462|"~     The purpose of this study in to analyse the way in which the body processes Niagen~     (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are~     given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the~     dose.~   "
66153|NCT02191449|"~     Warfarin therapy is usually monitored using the international normalized ratio (INR), and~     prolonged INR means coagulation impairment that can leads elevating transfusion requirement~     after operation. This study was designed to assess the relationships with warfarin and TEG~     values related to transfusion amount, to set up blood transfusion strategy in patients on~     atrial fibrillation undergoing cardiac surgery.~   "
66154|NCT02191436|"~     Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter~     study. Multicenter cross sectional study of patients with hemophilia and their families~   "
66155|NCT02191423|"~     Rationale and Hypotheses of the Current Research: the investigators speculate that mothers~     suffering from PPD exhibit high levels of depression and low levels of OXT, hence~     experiencing the interaction with their child as less rewarding, which in turn promote~     further depressive symptoms and interfere with child development. While dyadic psychotherapy~     has been studied in this context, it is unknown which depressed women will respond to this~     type of therapy, and whether such a response is mediated by the pro-bonding effect of~     oxytocin.~      The aim of this study is three-fold:~        1. To study the effect of the administration of a single dose (24IU) of oxytocin on~          cerebral circuit processing and connectivity of empathy and attachment.~        2. To examine whether the clinical response of mothers suffering from postpartum~          depression to short term dyadic psychotherapy (based on improved mother-child~          interactions) can be predicted by a unique brain response pattern to oxytocin.~        3. To assess the relationship between levels of oxytocin in mother and baby and the~          effectiveness of psychological dyadic treatment on mothers suffering from postpartum~          depression.~   "
66190|NCT02190968|"~     Many patients report residual depressive symptoms despite seemingly successful treatment.~     With the investigators' previous funding, we developed - Mindful Mood Balance - an online~     treatment that targets RDS by teaching specific emotion regulation and depression~     self-management skills that are entirely compatible with antidepressant treatment. The~     investigators now propose a controlled study to determine whether MMB is more effective than~     usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery~     format would provide high fidelity and low-cost empirically supported management of residual~     symptoms, leading to more robust remission, improved functioning and sustained recovery from~     MDD over time.~   "
68519|NCT02160457|"~     The aim of this study is to test the hypothesis, that improvements in gait pattern following~     individually tailored interventions guided by instrumented 3-dimensional gait analysis are~     superior to those used in 'care as usual'.~   "
66156|NCT02191410|"~     The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards~     Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during~     one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%,~     specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory~     pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and~     rhythm, and ventricular function and afterload,6-7 all have been documented to have effects~     on the SVV.~      SVV is calculated as the variation of beat-to-beat SV from the mean value during the most~     recent 20 seconds of data: SVV = (SVmax − SVmin)/SVmean, where SVmax, SVmin, and SVmean are,~     respectively, the maximum, minimum, and mean SV determined by the system.~      SVV may not be sufﬁciently sensitive to predict fluid responsiveness in patients with right~     ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a~     decrease in preload variation and subsequent inaccuracy in SVV measurements.8~      OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic~     volume, and stroke work index, thus impeding RV function.9-11The increases in the right~     ventricular afterload may exaggerate the cyclic variation in stroke volume.12~      In the authors' previous study,9 they found that the high-frequency positive-pressure~     ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV,~     resulting in significantly higher RV ejection fraction, lower RV afterload and higher~     arterial oxygenation, whereas the former limiting the adequate operative field visualization~     during video-assisted thoracoscopic surgery (VATS).13~      The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid~     responsiveness during OLV has not yet been studied.~   "
66157|NCT02191397|"~     This multi-centre study will follow a randomised, double-blind, parallel-group,~     active-controlled design and will evaluate the efficacy, safety and tolerability of~     bupropion extended-release (XL) (300 mg/day) compared with escitalopram (10-20 mg/day) in~     outpatients and inpatients with major depressive disorder (MDD). The total duration of the~     study will be 11 weeks consisting of three phases. The screening phase (phase I) will be~     lasting for 0-14 days, subjects will be randomised to bupropion XL or escitalopram in a 1:1~     ratio for acute phase treatment phase (phase II) for 8 weeks. There are 3 dose levels during~     this acute treatment phase. The 3-dose level plan is designed to ensure each drug is~     titrated according to the prescribing information and to reach an optimal clinical dose.~     Finally patients will enter the taper phase (phase III) for up to 1 week to assess and~     reduce the possible withdrawal symptoms.~      In China almost all existing antidepressants are available on the market, but bupropion XL~     has not yet been approved. This Phase III clinical trial will be used for the purpose of~     registering bupropion XL in China.~   "
66158|NCT02191384|"~     The purpose of this study is to determine whether Orcinoside Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in~     the Chinese Patients with Depression.~   "
66159|NCT02191371|"~     One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral~     microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational~     anesthetics can be used during one-lung ventilation. However, there is still a controversy~     which anesthetic would be more appropriate during one-lung ventilation in the perspective of~     oxygenation and microcirculation. The investigators hypothesized that intravenous and~     inhalational anesthetics may affect oxygenation and microcirculation differently during~     one-lung ventilation.~   "
66160|NCT02191358|"~     This multicenter observational study aims to investigate the benefits of providing~     pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a~     clinical decision support tool and individualized pharmacist recommendations to elderly~     polypharmacy patients who are most at risk of adverse drug events. The YouScript system is~     unique in identifying drug-gene, and drug-drug-gene interactions that are missed by existing~     systems, and represent over 35% of significant interaction warnings. Data analysis will~     assess the impact of recommendations for medication changes on clinical decision making,~     patient outcomes, and healthcare resource utilization to determine which medications,~     specialties, or patient segments derive the greatest benefit from this intervention. Data~     gathered from patients enrolled in this study will be compared to patients matched on key~     characteristics from Inovalon's MORE2 healthcare database.~   "
66161|NCT02191345|"~     Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for~     4 weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and~     vicarious trauma in Fronltine Service staff.~      Primary Aim B. To determine if staff will continue to listen to guided imagery after the~     first 4 weeks of the study is over.~   "
66162|NCT02191332|"~     Observational study to collect data on maintaining anti-retroviral activity (quantitative~     HIV RNA determination) and immunological activity (CD4 cells) despite switching from~     protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).~   "
66163|NCT02191319|"~     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)~     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to~     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and~     liver enzymes.~   "
66164|NCT02191306|"~     Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients~     on Long-Term Antiretroviral Therapy~      Intro:~      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary~     artery disease. Studies have documented this with various methods including analyzing the~     effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and~     hypertension. Still other studies have looked at carotid and brachial artery intimal~     thickness. Our study, then, aims to evaluate the relationship between HIV medications and~     coronary atherosclerosis using a novel method. Coronary artery CT angiography is a~     relatively new diagnostic procedure to evaluate heart disease in cardiac patients. We will~     apply this test to HIV patients on longstanding antiretroviral therapy to directly examine~     their coronary arteries to assess heart disease.~      Hypothesis:~      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary~     artery disease compared to the general population.~      Methods:~      This project will be conducted in collaboration between Florida Heart Center and Associates~     in infectious Disease - two communities based infectious disease and cardiology practices.~     We will identify all the HIV positive patients seen within a 1 month timeframe at the~     infectious disease office. These patients will then be filtered by our exclusion/inclusion~     criteria. After obtaining informed consent, we will draw blood from each patient to gather~     lab values such as A1C, cholesterol, inflammatory markers, and other markers associated with~     coronary artery disease. Each enrolled patient will then schedule and receive a 64 slide~     coronary CTA at Florida Heart Center. The results of the CTA scans will be categorized in~     mild, moderate, and severe coronary artery disease. The data, then, will consist of the~     parameters measured on blood work, and the results of the coronary CTA.~      Inclusion Criteria:~      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.~      Exclusion Criteria:~      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or~     heart surgery.~      Statistical Analysis:~      We will conduct a multivariate analysis on the cardiac risk factors taken from patient~     history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the~     CTA. We will also conduct basic analysis to support our hypothesis that long term~     antiretroviral therapy increases coronary artery disease.~      Funding:~      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies~     where available. In cases where insurance companies will not pay, Florida Heart Center will~     pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.~      Humans Subjects Protection:~      This will be a projective chart review study that will require access to protected health~     information. Thus, we will seek full IRB approval from the FSU IRB committee with informed~     consent. An informed consent document will be given to each patient explaining all the risks~     and benefits of the study in addition to the methods. Recruitment will be done by an office~     staff or medical assistant not on the research team. After patient recruitment, their~     medical records will be flagged for study and they will undergo the required testing. At~     completion of testing, their results will be recorded in the final data sheet, and their~     medical record will no longer be flagged for study. No identifying data will be recorded in~     the final data sheet, and the data will be stored in an encrypted excel sheet on a secure~     password protected personal laptop running antivirus and firewall. Third parties (such as~     family members) will not have access to any research data regardless of authorizations~     received from the study subjects. All the test results and labwork performed for the study~     will go into the patient's individual medical record at their respective offices. Thus, if~     an authorized third party wishes to view any test results, they can do so via the normal~     methods at the doctor's office.~   "
66165|NCT02191293|"~     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)~     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to~     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and~     liver enzymes.~   "
66166|NCT02191280|"~     Study to determine the efficacy and tolerability of two dose levels of Antistax relative to~     placebo in patients suffering from CVI grade I or incipient grade II~   "
66188|NCT02190994|"~     The purpose of this four-arm randomized controlled study is to determine whether eliminating~     glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar~     lesion could result in similar or better outcomes comparing to traditional replacement~     therapy, regarding postoperative recovery of pituitary function and other postoperative~     complications (infection, pain, quality of life, recurrence). Surgical patients of our~     center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance~     test (ITT) will be performed for assessment of the pituitary function at enrollment.~     Patients with normal pituitary function will be randomized into non-GC replacement group~     (group A) and low-dose GC replacement group (group B), while patients with impaired~     pituitary function will be randomized into low-dose GC replacement group (group C) and~     high-dose GC replacement group (group D). The primary outcome is the~     hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma~     cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the~     hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free~     T3, free T4), postoperative water-electrolyte balance, infection, recurrence and~     health-related quality of life.~   "
66167|NCT02191267|"~     Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with~     symptoms that include memory loss, problems with impulse control, and depression that can~     lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only~     be diagnosed postmortem where an over-accumulation of a protein called tau is observed.~     There is now a new experimental measure that makes it possible, for the first time, to~     measure tau protein in the living human brain using a novel positron emission tomography~     (PET) ligand, [F-18] AV-1451 (aka, [18F]-T807).~      The main objective of this study is to use a novel PET approach to measure tau accumulation~     in the brain. The presence of CTE at autopsy in deceased National Football League (NFL)~     players has been well documented. Accordingly, we will conduct this study in a group of~     retired NFL players who have clinical symptoms of CTE and are suspected of having CTE based~     on high levels of tau in their spinal fluid and abnormalities seen on research brain scans.~     We will compare them with a control group of former elite level athletes who have not~     experienced any brain trauma, deny any clinical symptoms, and who have completely normal~     spinal fluid tau and amyloid levels, and brain scans. We will also include a group of~     subjects with AD. All participants will be recruited from ongoing studies, headed by the~     Partnering PI of this proposal, Dr. Robert Stern, at the Boston University Center for the~     Study of Traumatic Encephalopathy and the Alzheimer's Disease Center. We will use both a~     beta amyloid PET scan ([18F]-florbetapir) and a tau PET scan ([18F]-T807) on consecutive~     days. With the beta amyloid scan we expect little or no evidence of amyloid in the NFL~     players with presumed CTE, and no evidence of amyloid in the control group of athletes with~     no history of repetitive brain trauma. In contrast we expect to see beta amyloid~     accumulation in the AD patient brains. With the new tau ligand, we expect that the NFL~     players with presumed CTE will show elevated levels of tau protein in the brain, which will~     not be observed in athletes without a history of brain trauma, but which will be seen in the~     AD patients' brains.~      Another goal is to use the latest MRI technologies to develop specific tau imaging~     biomarkers that correlate with the PET and spinal fluid tau measures but without the~     radiation of PET or invasiveness of spinal taps. The development of these surrogate imaging~     markers of tau, is critically important to diagnosing CTE. This in turn will lead to studies~     relevant to treatment and prevention of this devastating disease. Finally, as an exploratory~     method of examining possible genetic risk for CTE, we will also use cutting edge genetic~     analysis of blood samples from subjects in this proposal and compare tau load, measured by~     PET tau ligand uptake and cerebrospinal fluid (CSF) p-tau level, with a measure of genetic~     susceptibility to tau load, referred to as the genetic risk score for tau.~   "
66168|NCT02191254|"~     Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients~     with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location,~     Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)~   "
66169|NCT02191241|"~     To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol~     glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf~     Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this~     dose in healthy subjects.~   "
66170|NCT02191228|"~     The main objective of this study was to assess the effect of normal and impaired renal~     function on the safety, pharmacokinetics, and pharmacodynamics of linagliptin following oral~     administration of 5 mg daily for 7 days (Groups 1 to 3), 5 mg daily for 10 days (Groups 6~     and 7), or as a single dose (Groups 4 and 5)~   "
66171|NCT02191215|"~     The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of~     nevirapine in the management of the HIV/AIDS in an open environment.~   "
66172|NCT02191202|"~     Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of~     life of HIV-positive patients~   "
66173|NCT02191189|"~     Study to determine the absorption of Nevirapine from different regions of the Gastro~     Intestinal tract.~   "
66174|NCT02191176|"~     The primary objective of the current study is to investigate the safety with special~     emphasis on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate~     (2mg/mL syrup) in healthy male and female subjects following oral administration of 30 mg~     q.i.d. and 90 mg q.i.d. for 2 days followed by a single morning dose (extensive metabolisers~     of CYP 2D6) and for 10 days followed by a single morning dose (poor metabolisers of CYP~     2D6).~      Additionally pharmacokinetic properties of dextromethorphan and its main metabolites~     dextrorphan, 3-hydroxymorphinan, and 3-methoxymorphinan will be investigated~   "
66175|NCT02191163|"~     Study to determine the efficacy and safety of Antistax® film coated tablets in improving~     microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)~   "
66176|NCT02191150|"~     The study will obtain data to show insight into clinical outcomes of patients switching from~     Darbepoetin Alfa to a epoetin alfa biosimilar.~   "
66177|NCT02191137|"~     The MOTION study is a prospective, Phase IV study, enrolling 61 patients with Pulmonary~     Arterial Hypertension (PAH). The study designed to further explore patient-reported outcomes~     in PAH subjects who are not on active treatment and living in the United States. In~     addition, the study will be exploring the use of new telemetric technology (Accelerator~     band) to evaluate if this technology correlates with improvements in 6 Minute Walking~     Distance 6MWD in patients with PAH~   "
66178|NCT02191124|"~     In recent years, measurement-based care (MBC) has been gaining more attention in the~     treatment of depression because it allows psychiatrists to individualize treatment decisions~     for each patient based on the change of psychopathology and tolerance toward~     antidepressants. Several studies, such as the Sequenced Treatment Alternatives to Relieve~     Depression (STAR*D) trial using MBC, found that MBC-informed sequential algorithms can be~     successfully integrated into clinical practice and improve patients' outcomes However,~     despite a strong theoretical rationale for MBC and data supporting the ability to implement~     MBC in clinical practice settings, there is currently no randomized controlled trial in MDD~     patients comparing MBC with usual/standard care. The investigators compare MBC with~     clinician's treatment decisions, standardizing care to two commonly prescribed~     antidepressants.~      Therefore, the aim of this study is to determine the effects of MBC in patients with MDD~     compared to standard treatment (ST). The research hypothesis is that compared to ST, the~     estimated time to response and to remission would be significantly shorter in the MBC group~     without increased dropout rates and side effect burden.~   "
66189|NCT02190981|"~     The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing~     small bowel obstruction in emergency department patients, as compared to the criterion~     standards of computed tomography, operative reports, or discharge diagnosis.~      The secondary purposes of the study include evaluation of the effect of ultrasound for small~     bowel obstruction on the patient length of stay in the emergency department and the~     diagnostic utility of specific ultrasound findings in the diagnosis of small bowel~     obstruction. The study will also examine the inter-rater agreement between point-of-care~     sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.~   "
66191|NCT02190955|"~     The purpose of this study is to learn about patient, caregiver and healthcare worker~     perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients~     enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to~     participate in this study.~   "
66179|NCT02191111|"~     Background: Despite evidence of benefit for pharmacist involvement in chronic disease~     management, the provision of these services in community pharmacy has been suboptimal. The~     Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests~     that for knowledge translation to be effective, there must be evidence of benefit, a context~     conducive to implementation, and facilitation to support uptake. We hypothesize that while~     the evidence and context components of this framework are satisfied, that uptake into~     practice has been insufficient because of a lack of facilitation. This protocol describes~     the rationale and methods of a feasibility study to test a facilitated pharmacy practice~     intervention based on the PARiHS framework, to assist community pharmacists in increasing~     the number of formal and documented medication management services completed for patients~     with diabetes, dyslipidemia, and hypertension.~      Methods: A cluster-randomized before-after design will compare ten pharmacies from within a~     single organization, with the unit of randomization being the pharmacy. Pharmacies will be~     randomized to facilitated intervention based on the PARiHS framework or usual practice. The~     Alberta Context Tool will be used to establish the context of practice in each pharmacy.~     Pharmacies randomized to the intervention will receive task-focused facilitation from an~     external facilitator, with the goal of developing alternative team processes to allow the~     greater provision of medication management services for patients with diabetes,~     hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the~     needs of community pharmacies to provide more clinical services, the acceptability and~     uptake of modifications made, and the willingness of pharmacies to participate. Secondary~     outcomes will include the change in the number of formal and documented medication~     management services in the aforementioned chronic conditions provided 6 months before,~     versus after, the intervention between the two groups, and identification of feasible~     quantitative outcomes for evaluating the effect of the intervention on patient care~     outcomes.~      Results: To date, the study has identified and enrolled the ten pharmacies required and~     initiated the intervention process.~      Conclusion: This study will be the first to examine the role of facilitation in pharmacy~     practice, with the goal of scalable and sustainable practice change.~   "
66180|NCT02191098|"~     To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of~     ALT-803 in HIV~   "
66181|NCT02191085|"~     Access to medical care for patients with breathing disorders during sleep is a major problem~     for Canadians. Recently, there has been increasing interest in how health care providers who~     are not physicians can help to improve access to medical care for these patients, but it is~     unclear whether patients with severe sleep-disordered breathing who receive care from these~     non-physician providers have the same response to treatment as patients who receive care~     from physicians. Since these severe have a high risk of developing cardiac and respiratory~     complications and of being hospitalized, an initiative to improve access such as the use of~     non-physician providers could be of great benefit to individual patients and the health care~     system.~      The objectives of this project are:~        1. to determine whether patients with severe breathing disorders during sleep have the~          same response to treatment when cared for by non-physician health care providers~          (respiratory therapists) as they do when cared for by physicians;~        2. to determine the effects of non-physician health care provider treatment to patient~          access;~        3. to determine health care utilization and related costs associated with non-physician~          health care provider treatment.~   "
66182|NCT02191072|"~     Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II~     and phase III studies. Clinical symptoms and signs had been significantly reduced with~     omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic~     spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab~     had an onset of effect within a week after initiation. Thus, the investigators hypothesize~     that omalizumab will be effective in the treatment of severe acute urticaria as add on~     therapy with a fast onset of action. Objective:To investigate the efficacy and safety of~     omalizumab in the treatment of severe acute urticaria Study design: This prospective,~     interventional, single-arm open label study will recruit patients with severe acute~     urticaria from emergency departments, hospitalized and outpatient departments. The included~     patients will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy~     of omalizumab will be evaluated by physical examination and assessed by Urticaria Activity~     Score (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy.~     The frequency and severity of treatment-emergent adverse events will also be evaluated~   "
66183|NCT02191059|"~     1. There is as yet no optimal treatment regimen for patients with epidermal growth factor~          receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .~        2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang~          BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the~          similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed~          icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,~          anti-tumor activities were observed in patients with advanced NSCLC.~        3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in~          combination with Docetaxel as second-line treatment for NSCLC patients with wild type~          EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall~          survival(OS) and health related quality of life(HRQoL) will be monitored.~   "
66184|NCT02191046|"~     The purpose of this study is to the effect of squeezable bottle nasal irrigation device with~     syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation~   "
66185|NCT02191033|"~     This study is a randomized-controlled clinical trial which evaluates the efficacy of~     physician brief advice, nicotine replacement therapy and a 6-week course of text messaging~     in promoting cigarette smoking in smokers enrolled in college.~      The primary hypothesis is that smokers receiving physician brief advice, nicotine~     replacement therapy, and text messaging will have higher quit rates that smokers receiving~     physician brief advice and nicotine replacement therapy alone.~   "
66186|NCT02191020|"~     This is a randomized, double blind, placebo parallel-controlled, multi-center clinical~     trial. Patients with psoriasis vulgaris were randomly divided into the experiment group~     （treated with TGP combined with acitretin capsules) and control group （treated with placebo~     combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety~     were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of~     treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe~     and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.~   "
66187|NCT02191007|"~     Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol~     Ointment in sequential therapy~   "
66192|NCT02190942|"~     The purpose of this study is to provide validation of patient-reported data in the VCRC~     Patient Contact Registry by comparing patient-reported data with data provided by the~     physician who is the primary provider caring for the patient's vasculitis. Patients enrolled~     in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with~     polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with~     polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN),~     and Takayasu's arteritis (TAK) were invited via email to participate in this study.~   "
66193|NCT02190929|"~     A cross-sectional study design and online questionnaire was used to assess the informational~     needs of patients with several different types of systemic vasculitis. Patients were~     recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient~     Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry~     were compared to responses from a similar survey recently administered to patients within a~     United Kingdom (UK) based vasculitis support group (Vasculitis UK).~   "
66194|NCT02190916|"~     The purpose of this study is to learn about how patients with vasculitis think about their~     illness and to assess to what extent patient perceptions of illness are associated with~     physical, mental, and social functioning~   "
66195|NCT02190903|"~     This pilot project will address the gaps in knowledge regarding the effect of anesthetic~     technique on the risk of delirium through an adequately-powered trial employing standardized~     regimens for treatment and outcome assessment to test the hypothesis that use of spinal~     versus general anesthesia decreases the risk of delirium after hip fracture surgery.~   "
66196|NCT02190890|"~     The purpose of this study is to determine the effectiveness of different dry needling~     dosages in the treatment of myofascial trigger points in the upper trapezius muscle in~     patients with myofascial neck pain.~   "
66197|NCT02190877|"~     This study is designed to validate ease-of-use for the CoVa Monitoring System, along with~     simple statistical parameters such as reproducibility and inter-subject agreement between~     test and reference devices.~   "
66198|NCT02190864|"~     Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences~     into clinical treatment planning.~   "
66199|NCT02190851|"~     Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was~     reported at the congress of the Société Interdisciplinaire Francophone d'UroDynamique et de~     Pelvi-Perinéologie (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients~     with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder.~     Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated~     with subjective improvement of LUTD assessed with the Patient Global Impression of~     Improvement (PGI-I) in 5 of the 6 patients.~      In view of the encouraging results of this pilot study, we hypothesize that TENS treatment~     may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and~     multisystem atrophy (MSA).~   "
66200|NCT02190838|"~     Treatment of disseminated melanoma is still a difficult issue. Obvious achievements of~     recent years proves efficacy of immunologic approachees in this field. The ability of~     melatonin and metformin to decrease metabolic immunosuppression was shown in many~     experimental studies. Some literature data confirm the possibility of increasing efficacy of~     melatonin with dacarbazine (DTIC) and metformin with DTIC combinations. We hypothesized that~     this combinations could be more effective than DTIC monotherapy in terms of response rate~     and time to progression.~   "
66201|NCT02190825|"~     This study aims to investigate the safety, efficacy, peri and postoperative complications,~     and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of~     pelvic organ prolapse (POP).~      Prolapse staging for all subjects in this study will be performed according to the POP-Q~     staging system.~      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and~     will be performed if required by qualified personnel~   "
66202|NCT02190812|"~     Use the system to evaluate of wrist muscle strength.~   "
66203|NCT02190799|"~     Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in~     September 2012, more than 800 cases have been reported to the World Health Organization~     (WHO) with substantial mortality.~   "
66204|NCT02190786|"~     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of~     multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.~   "
66205|NCT02190773|"~     In the present clinical study including chronic, aggressive periodontitis and healthy~     individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),~     Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and~     after surgical periodontal treatment and search out the relationship of clinical parameters~     with these cytokine levels.~   "
66206|NCT02190734|"~     Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this~     study is to see if there are immediate changes in pushing behaviors in individuals who have~     had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking~     overground.~      The investigators do not think there will be a change with sitting in the wheelchair, but~     the investigators think there may be an improvement in pushing behaviors after walking~     training.~   "
66207|NCT02190721|"~     The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children~     and adolescents with solid tumors without bone marrow involvement.~   "
66208|NCT02190708|"~     Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours)~     and is primarily metabolised by CYP3A.~      Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid~     secretion. Omeprazole is primarily metabolised by CYP2C19.~      Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to~     evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and~     the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.~      The aim of this study is to assess the effect of PQ912 on the PK of midazolam and~     omeprazole. In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes,~     including CYP3A4 and CYP2C19 and at the expected exposure levels in patients, has the~     potential to inhibit these enzymes in-vivo. This study is therefore planned to investigate~     the potential changes in the PK of midazolam and omeprazole due to the effect of PQ912 at~     steady-state. In clinical practice it is likely that co-administration of PQ912 with other~     drugs that are metabolised via the CYP3A and/or CYP2C19 enzymes will occur. This study will~     provide important information for the requirement of dose adjustments or contraindications~     in these circumstances.~   "
66209|NCT02190695|"~     The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML),~     Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are~     used to treat AML and MDS but are not usually combined together. The investigators are~     looking at both the safety and Efficacy of each combination.~   "
66210|NCT02190682|"~     Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%.~     This high incidence effects quality of life of patients causes social-economical problems~     and arises medico-legal issues. This study will be undertaken for producing a database by~     the evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used~     in establishing a software by using data mining technology in the prediction of PPP~   "
66211|NCT02190669|"~     This proposal seeks to gather continuous blood glucose and physical activity data from~     individuals with and without diabetes.~   "
66212|NCT02190656|"~     Bowel cancer is the third most common cancer in the UK in both males and females. The rectum~     is the most commonly affected part of the bowel. Improvements in surgery have meant that~     many patients with rectal cancer can now undergo surgery that removes the rectum and avoids~     a permanent stoma. The operation that most patients have is an anterior resection of the~     rectum.~      Unfortunately this surgery frequently leads to a change in bowel function, with patients~     suffering from incontinence, urgency and unpredictability a problem known as anterior~     resection syndrome. These problems are believed to be fairly common following surgery but~     follow up appointments have traditionally concentrated on ensuring that the cancer has not~     returned and have not reviewed functional outcomes in enough detail. Because of this we are~     unsure exactly how common the problems described are.~      The proposed study will allow us to determine how many patients have ongoing symptoms~     following their surgery for rectal cancer. It will also allow us to use a newly developed~     scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK~     population, to ensure that it can accurately be used in the future to measure the problem~     and aid development of new therapies. An appreciation of the impact of symptoms on~     postoperative quality of life will encourage routine assessment of functional outcomes in~     clinical practice, allowing identification of patients who may benefit from treatment.~   "
66213|NCT02190643|"~     The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive~     smokers focused on improving adherence to using the nicotine skin patch.~   "
66214|NCT02190630|"~     The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring~     following wear of a twin block functional appliance (removable brace which postures the~     lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing~     time periods.~   "
66215|NCT02190617|"~     The primary hypothesis the investigators will test is that that improving asthma guideline~     implementation and providing patients with a unified asthma management plan using a~     multi-component and multilevel intervention will improve patient-centered asthma outcomes~     compared to health plan case management, passive guideline dissemination and provider~     education.~   "
66216|NCT02190604|"~     This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary~     pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis~     patients following single and multiple doses. This first-in-human and proof of concept study~     will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in~     cystic fibrosis patients.~   "
66217|NCT02190591|"~     The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after~     epidural anesthesia in patients who have never given birth. The study will measure the~     impact on the length of labor, cesarean section rate, operative vaginal delivery rate~     (vacuum or forceps use), and third or fourth degree laceration rates. This study will~     determine the impact of PLB use by comparing two cohorts of nulliparous patients: one with~     the PLB use and one with traditional wedge and pillow positioning. If benefits related to~     use of the PLB can be demonstrated, it is our intention that each labor room will be stocked~     with a PBL for use as standard of care.~      This study will test the following hypotheses:~        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal~          delivery rate in low risk nulliparous patients who receive epidural anesthesia compared~          to similar cohort using traditional wedge and pillow positioning.~        2. Using the PLB will impact the amount of time from epidural placement to complete~          dilation and the time of second stage of labor, when compared with the control cohort.~        3. Use of the PLB will impact the third and fourth degree laceration rates when compared~          with the control cohort.~   "
66218|NCT02190578|"~     To determine the efficacy of an improved rapid diagnostic test using venous whole blood and~     fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test~     will be determined by comparing the results with patient infected status for HIV-1 (human~     immunodeficiency virus type 1).~      The study will consist of a single one-hour visit, at which time blood samples will be~     collected and tested with the investigational device (Reveal G4) and FDA approved comparator~     assays for detection of HIV-1 antibodies.~   "
66219|NCT02190565|"~     The purpose of this study is to determine whether a food supplement consisting of vitamins,~     minerals and fish oil taken during and after pregnancy can decrease the need for additional~     iron supplementation due to anemia during pregnancy, and optimize levels of nutritional~     markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal~     blood and breast milk, compared to placebo.~   "
66220|NCT02190552|"~     A.R.I.S.E. is a post approval observational study using standard care. The purpose of this~     study is to collect information about the ability of the EmboTrap device to remove blood~     clots from the brain, and the associated performance characteristics and clinical outcomes.~     No formal hypothesis testing is needed as no comparisons are planned within the study.~     Instead, estimates of each population parameter of interest for all primary and secondary~     endpoints will be provided using appropriate confidence intervals.~   "
66221|NCT02190539|"~     The objective of this study is to conduct a feasibility study at Meir Oncology Institute~     examining whether patients with advanced breast cancer would follow a homeopathic protocol~     for three to six months.~      The primary aim of the study is to establish if patients with advanced breast cancer in Meir~     Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for~     six months.~      The secondary aim is to observe the quality of life and wellbeing of patients undergoing~     this protocol~   "
66231|NCT02190409|"~     The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF~     application on implant osseointegration in the early phase of healing.~   "
66222|NCT02190526|"~     The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on~     the Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant~     Irritable Bowel Syndrome (IBS-D).~      All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS)~     , Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the~     beginning of trial and at weeks 2,4,6 and 8 of treatment.~      Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a~     clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for~     the first time to our private gastrointestinal clinic from 2014 until 2016.~      All patients who meet the inclusion criteria enrolled for a 2-week period screening phase.~     In order to exclude patients with Lactose intolerance, all patients take a lactose-free diet~     for 14 days before inclusion and patients whose symptoms improve by this regimen will be~     excluded.~      This trial is a double-blind study and all patients will be assigned randomly to three~     groups:~        1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to~          Amitriptyline (10 mg/HS) for 8 weeks~        2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like~          Asacol (800 mg/ TDS) for 8 weeks~        3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and~          placebo similar to Amitriptyline (10 mg/HS) for 8 weeks~      Ethical considerations:~        1. All patients will fulfill an informed consent~        2. Drugs are available without any charge~        3. Observation of Helsinki ethical statement~   "
66223|NCT02190513|"~     Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the~     gastrointestinal tract with specific clinico-pathological characteristics. In recent years,~     in the literature, several children who underwent upper gastrointestinal endoscopy for~     suspected CD, which was confirmed histologically, were also found to have coexistent EE.~     There are reports of coexistent CD and EE. We would like to see the prevalence of EE in~     children with CD and the prevalence of CD in children with EE in our population, and to do~     so would like to review medical records. Our objectives are to determine if children with~     celiac disease have a high prevalence of eosinophilic esophagitis.and to determine if~     children with eosinophilic esophagitis have increased risk of developing celiac disease.~   "
66224|NCT02190500|"~     The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis~     and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with~     subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for~     further management, to standard pre-hospital triage and transport by Emergency Medical~     Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).~   "
66225|NCT02190487|"~     Acute kidney injury (AKI) is one of the most frequently encountered and prognostically~     significant complications after cardiovascular surgery. However, there is no definitive~     treatment to intervene after development of AKI, therefore, preventive strategy has been the~     major issue. By this time, incidence of AKI after cardiovascular surgery has been reported~     3-50% based on the studies with various definition of AKI and different patient cohorts.~     Development of unified definition for AKI in the early 2000s opened a new era in AKI study.~      According to the previous studies, aortic surgery, especially thoracic aortic surgery was~     known to be highly prevalent of AKI, which was considered to be caused by use of total~     circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion~     syndrome before surgery and relatively complicated surgical procedure. However, there has~     not been many studies of AKI in thoracic aortic surgery because of its low incidence and~     urgent clinical presentation of aortic pathology, which hinder large randomized controlled~     study. Moreover, there are conflicting reports of incidence and risk factors of AKI after~     thoracic aortic surgery, no conclusive result has been made. Therefore, this study was~     designed to investigate the incidence and risk factors after thoracic aortic surgery only~     due to dissection.~   "
66226|NCT02190474|"~     The primary objective of this study to determine the feasibility and acceptability of a~     mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain~     and other similar chronic symptoms.~   "
66227|NCT02190461|"~     Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory~     Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted~     patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life~     related to health (HRQOL).~   "
66228|NCT02190448|"~     The overall aims of this project are to 1) determine the quality of life effects and safety~     of a combination herbal galactagogue tea in lactating women, and 2) measure changes in~     maternal blood concentration of oxytocin, prolactin, and milk production. The defined~     outcome measures will include quality of life measures and safety parameters in the~     breastfeeding woman and basic infant health. If the tea proves safe and effective, then it~     can provide a proven all-natural and organic supplement for increasing lactation in women.~     This in turn will increase quality of life for both the infant and the mother.~   "
66229|NCT02190435|"~     There are approximately 250,000 hip fractures in the US every year, and intertrochanteric~     (IT) fractures (fractures that occur just below the femoral head) account for nearly half of~     these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has~     become a well-accepted and increasingly more common procedure among orthopaedic~     traumatologists, and is standard of care at our institution.~      While advancements in intramedullary nail fixation have made it a relatively efficient~     procedure, the placement of the lag screw into the femoral head still remains a challenging~     step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most~     commonly reported complications with IM nail fixation. Previous work has shown that the lag~     screw position is an important factor in reducing screw cut-out. This step of the procedure~     can be time demanding and often requires several intraoperative radiographs for accurate~     placement. Recently developed computer-assisted navigation systems provide surgeons with the~     ability to track screw placement in real-time. This could allow for improved screw placement~     and potentially reduce radiation exposure to the patient and surgeon. To date, the potential~     advantages of computer-assisted navigation have not been examined.~      The primary objective of this study is to examine whether the use of Stryker's ADAPT~     computer-assisted navigation for Gamma nail fixation can result in improved lag screw~     placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail~     fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a~     difference in the lag screw placement (i.e. tip to apex distance measurement) between~     procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.~     Additionally, we hypothesize that there is a difference in radiation exposure (i.e.~     fluoroscopy time) between procedures using the ADAPT system versus the conventional~     technique for Gamma nail fixation.~   "
66230|NCT02190422|"~     Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile~     couples. However, the long-term effect of ART exposure on cardiovascular development and~     potential association with ART procedure and parental factors is confused. The aim is to~     shed more light on the pattern and extent of cardiovascular developmental alteration among~     ART children and its association with potential confounders.~   "
66232|NCT02190396|"~     Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The~     role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at~     placental pathologies is unknown. Placental calcification is usually thought to be a~     physiological aging process. Nevertheless, it can be a pathological change resulting from~     the effects of environmental factors on the placenta. The aim of the investigators study was~     to evaluate the relationship between placental calcification and maternal and cord blood~     25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population~     at term and their consequences.~   "
66233|NCT02190383|"~     The main purpose of this study is to evaluate the efficacy of a habit reversal based~     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.~   "
66234|NCT02190370|"~     The main purpose of this study is to evaluate the efficacy of a resources activation based~     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.~   "
66235|NCT02190357|"~     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and~     increased intestinal permeability all leading to an increase in bacterial translocation and~     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral~     administration and exhibits broad spectrum antimicrobial activity against both aerobic and~     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.~     It has been suggested that oral prophylactic antibiotics or bowel decontamination might~     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore~     the effect of rifaximin on the complications of advanced cirrhosis.~   "
66236|NCT02190344|"~     The objective of this study is to determine the functionality of an eight-channel paddle~     coil system which is to be used in future MRI studies.~   "
66237|NCT02190331|"~     -  To evaluate the effects of a 32-weeks resistance and stretching training program~          applied in Physical Education classes on forward head and protracted shoulder~          Portuguese adolescents (15-17 years old).~        -  To evaluate on adolescents submitted to strength and stretching exercises the effects~          of a 16-week detraining period after the end of the intervention protocol.~   "
66238|NCT02190318|"~     Aldosterone blockade is useful in preserving residual renal function in patients on PD.The~     long term efficacy of dual blockade of the RAAS is better than monotherapy.~   "
66239|NCT02190305|"~     The purpose of this study is to determine the efficacy of two rapid diagnostic tests in~     plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of~     Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected~     status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV~     (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by~     comparing the results with patient infected status for HBV.~      Subject participation in the study will consist of a single one-hour visit, at which time~     blood samples will be drawn for testing with the investigational devices and with approved~     comparator assays. The test results, which are the outcome of the study, will be obtained~     only once, at the time of this visit.~   "
66240|NCT02190292|"~     Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating~     of the psychiatric illnesses, yet much remains unclear regarding causes and cures. A~     diagnostic subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or~     anorexia nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute~     onset Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory~     therapy or antibiotics, with a variable outcome. A diagnosis of PANS is supported by~     elevated levels of auto-antibodies and antibody-enzyme activity measured with the Cunningham~     panel, but the relationship between these biomarkers and the patients' symptoms remains~     unclear. A clinician rated symptom scale for PANS (the PANS scale) has been developed, but~     needs to be further evaluated regarding sensitivity and specificity.~      Aims:~        -  To assess a Swedish cohort of patients diagnosed with PANS and compile their~          psychiatric health status, biomarkers, psychiatric symptoms, soft neurological signs~          and treatment outcomes in a systematic way~        -  To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor~          symptoms in this PANS cohort with a control group of psychiatric patients and with~          healthy children.~        -  To evaluate the Cunningham panel as a diagnostic tool for PANS.~        -  To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for~          PANS.~      Method: Observational study Participants: Patients (n≈150) who have been tested with the~     Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will~     be asked to participate.~      Procedure: Assessment of current symptoms, psychiatric health, neurological and motor~     symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective~     assessment through interview and medical records, including results from the first~     assessment with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of~     the total PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control~     group consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined~     with a similar test battery and signs and symptoms will be compared with the PANS group.~      Significance:~      Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will~     be investigated, thus knowledge regarding long-term outcome and evidence for the use of~     clinical assessment tools and biomarkers for diagnosing PANS will be gained.~   "
66241|NCT02190279|"~     Background:~      - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical~     called a radiotracer helps doctors get images of this type of cancer. Researchers want to~     test a radiotracer called 18F-DCFBC.~      Objective:~      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.~      Eligibility:~      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have~     relapsed, or has spread outside the prostate.~      Design:~        -  Participants will be screened with physical exam and medical history. They will give a~          blood sample.~        -  Participants will be divided into three groups.~      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or~     biopsy at NIH.~      Group 2: people who had their prostate removed or had radiation therapy and now have a~     rising prostate-specific antigen (PSA) without other signs of disease.~      Group 3: people whose cancer has spread to other areas of the body.~        -  Participants will have 18F-DCFBC injected into a vein then imaged in a PET/CT camera.~          During the scans, they will lie on their back on the scanner table.~        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the~          rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a~          contrast agent injected through an intravenous line.~        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21~          days of the 18F-DCFBC scan to look for prostate cancer in the bone.~        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.~        -  A few days after each scan, participants will be contacted for follow-up.~   "
66260|NCT02190032|"~     The investigators are trying to compare the individually modified-angled tube and the~     conventional-angled tube in ease of double lumen endotracheal tube insertion and the~     incidence of related postoperative complications.~   "
66395|NCT02188277|"~     1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in~          children with spastic equine and equinovarus foot deformation in pediatric cerebral~          palsy~        2. To assess the safety of Xeomin® use as compared to Botox® in this patient population~   "
66242|NCT02190266|"~     Background:~      - Coccidioidomycosis is caused by a fungus that grows in the southwest United States and~     parts of Mexico and South America. This disease is caused by breathing dust containing the~     fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect~     other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays~     in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM).~     People with DCM or RCM may have difficulty fighting off infection because of immune system~     problems. Researchers want to study the immune systems of people with DCM or RCM, to learn~     more about the disease and the best ways to treat it. They also want to learn more about the~     types of people that get DCM or RCM and about the fungus that causes it.~      Objectives:~      - To learn more about DCM and RCM, the fungus that causes these diseases, and the people who~     get them.~      Eligibility:~      - People over age 2 with DCM or RCM.~      Design:~        -  Participants will be screened with a review of their medical records.~        -  At the initial visit, participants will have:~        -  Medical history and physical exam~        -  Blood and urine tests. Some blood may be used for genetic testing. The samples will not~          include participants names. Participants will be notified only if the tests show~          something urgent about their DCM/RCM. Researchers think this sort of problem will be~          rare.~        -  Questionnaire about their DCM/RCM~        -  Sputum (mucus) collection. They will spit into a cup.~        -  Participants will have 1 follow-up visit per year for up to 5 years. They will have~          blood tests. They may have other procedures to treat their DCM/RCM.~   "
66243|NCT02190253|"~     Background:~      - The hepatitis E virus causes an acute hepatitis that usually goes away by itself.~     Researchers in France studied people who received a liver or kidney transplant. They found~     that hepatitis E may not go away by itself in these people. It becomes chronic. This can~     cause serious liver disease. More than half the people who had organ transplant who had~     hepatitis E seemed to get a chronic infection.~      Researchers want to find out if hepatitis E happens this often in patients who have liver,~     kidney, or small bowel transplants in the United States. If it does, they want to know why.~     They want to know if chronic hepatitis E will become an important medical problem. This~     research might help improve care for people who have a transplant. It also might help~     researchers prevent the spread of hepatitis E.~      Objective:~      - To see how many patients who have received or are waiting for certain transplants have~     antibodies to hepatitis E virus.~      Eligibility:~      - Adults over age 18 who have had a liver, kidney, liver and kidney, or small bowel~     transplant, or are on a waiting list for one.~      Design:~        -  Participants will be enrolled from 3 transplant centers.~        -  Participants will complete a questionnaire. They will be asked about possible risk~          factors for hepatitis E exposure.~        -  Participants will have a blood sample drawn through a needle placed in a vein.~   "
66244|NCT02190240|"~     The proposed study has 3 aims: 1) quantitatively describe a model for delivering~     complementary and alternative medicine (CAM) therapies to understand the selection of~     patients and CAM therapies used for pain management, 2) examine the effects of selected CAM~     therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies~     on duration of pain change.~      Positive results from this study will assist hospitals in the integration of usual care and~     CAM therapy for pain reduction. Findings may also drive future research on the cost~     effectiveness of these therapies for pain management, as well as the impact on patient~     outcomes such as length of stay and use of narcotics.~   "
66245|NCT02190227|"~     The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption~     Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast~     cancer treated with neoadjuvant chemotherapy.~      This is important because the earlier non-responders are identified, the greater is the~     impact of reducing side effects of ineffective treatments.~      The study hypothesis is that the RDA score will accurately predict for tumor response after~     one cycle of chemotherapy.~   "
66246|NCT02190214|"~     This will be a population based study looking at the prevalence of thyroid disorders in~     Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its~     association with different ethnicity and iodine status. The study will also look at genetic~     susceptibility for autoimmune thyroid disorders in the Malaysian population~      General hypotheses:~      The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for~     hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population~     There are different susceptibility gene for autoimmune thyroid disorder in different~     ethnicity in our population~   "
66247|NCT02190201|"~     The investigators previous study showed that McGrath Series 5 videolaryngoscope is an~     alternative tool for double-lumen tube intubation. But it is not determined about the~     advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube~     intubation, compared with traditional Macintosh laryngoscope.~   "
66248|NCT02190188|"~     Research on the implications of orthotic devices and the recovery after knee arthroscopy are~     widely known. But only a handful of specific issues have been studied to date. However, the~     effect of orthotic devices on the recovery after partial meniscectomy are largely unknown.~     To our best knowledge, there are no studies that deal with the treatment of partial medial~     or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this~     study is to find out if using wedge inserts or knee orthoses improve the outcomes after~     partial meniscectomy.~      We therefore verify the following hypothesis: In patients with partial meniscectomy can be~     by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a~     significantly better clinical outcome than without specific treatment.~   "
66249|NCT02190175|"~     This is a multicentre non interventional observational study with the objective to follow up~     patients with atrial fibrillation who based on current indications are treated with per os~     flecainide , for cardiac pulse maintenance.~   "
66261|NCT02190019|"~     Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of~     motivation, is a common behavioral problem in MCI. Presence of apathy may increase the~     chance of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic~     Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of~     refractory depression. Since dysfunction in the frontal lobe of the brain is seen in~     patients with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study~     hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve~     apathy and executive function better than sham treatment in those with MCI~   "
66250|NCT02190162|"~     The purpose of this study is to assess the effects of Tantum Verde® for improving recovery~     following tonsillectomy Study design: A prospective double-blined randomized trial. Sample~     size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth~     wash solution, and a control group of 30 patients that will undergo tonsillectomy and will~     be treated with a placebo.~      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the~     Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for~     tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign~     the inform consent in one of two places: in the departments before the surgery or in the~     clinic in the visit before the surgery. The patients will be evaluated for their ability to~     gargle and spit water before the surgery, after which they will be assigned to either the~     treatment group who will get a solution of Tantum Verde or the control group who will~     receive saline with mint flavor, both in identicle bottles. Randomization will be done using~     a random number generator program.~      The patients will be asked to gargle and spit the solution they received three times a day~     for 30 seconds, for the following week after surgery.~   "
66251|NCT02190149|"~     This 6-month prospective outcomes study addresses the association between timing of~     infusion, patient activity levels, and bleeding episodes through patient-reported~     measurements.~   "
66252|NCT02190136|"~     Stretching and flexibility exercise such as yoga and functional resistance exercise are two~     forms of exercise that are growing in popularity. However, they have not been scientifically~     tested to demonstrate their ability to improve body composition, fitness, heart and~     metabolic health, and mood state in overweight/obese women. The investigators hypothesize~     that during an 11 week intervention, both forms of exercise will improve body composition,~     heart and metabolic health and mood state.~   "
66253|NCT02190123|"~     REWINDER is a multinational, multicentre, non-interventional, retrospective study of~     patients treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in~     hospital after an acute coronary syndrome (ACS) event, to be conducted in Belgium and~     Luxembourg.~      Primary objective is to evaluate the actual treatment persistence with oral antiplatelets~     (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.~      The main secondary objectives are to describe the most frequent reasons for OAP treatment~     switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment~     changes and to characterize the patient profile in terms of demographics, diagnosis,~     management strategies, comorbidities and concomitant medications to identify any association~     between patient profile and treatment duration.~   "
66254|NCT02190110|"~     Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,~     shock/hypotension, or cardiac arrest. Discriminating patients in different categories of~     pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The~     most frequently used clinical prediction rule is the Wells score (PE likely > 4 points and~     PE unlikely ≤ 4 points). PE can be safely ruled out in patients with a PE unlikely~     associated with a negative d-dimer test result. Conversely, patients with PE likely or~     positive d-dimer level should undergo further diagnostic testing, like multidetector~     computed tomography pulmonary angiography (MCTPA).~      Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as~     an extension of physical examination and have a high specificity. The aim of this study is~     to evaluate if the combination of clinical data reported in the Wells score and US data~     obtained from vein and lung US (US Wells score) has a better diagnostic accuracy compared to~     traditional Wells score.~      In adult patients suspected of PE traditional Wells score will be calculated and vein and~     lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.~     The US Wells score differs from the traditional Wells score in the following items: signs~     and symptoms of DVT, replaced by vein US showing DVT, and alternative diagnosis less~     likely than PE replaced by alternative diagnosis less likely than PE after multiorgan US.~     This latter item is considered positive if at least one subpleural infarct is detected at~     lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis~     like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms~     of presentation. If no findings are detected at lung US, the points for the item remain the~     same assigned by traditional Wells score. Final diagnosis of PE will be preferentially~     established by MCTPA and in patients discharged without a second level imaging test because~     of negative Wells or d-dimer, and patients with not conclusive second level diagnostic test,~     will enter the 3 months follow-up protocol.~      The diagnostic performance of traditional and US Wells scores will be assessed by~     calculating sensitivity, specificity, positive, and negative predictive value, and~     likelihood ratios. Failure rate and efficacy of d-dimer in patients stratified as PE~     likely and PE unlikely will also be calculated.~   "
66255|NCT02190097|"~     Polycystic ovary syndrome (PCOS) is a syndrome which includes elevated androgen levels,~     irregular menstrual cycles and insulin resistance. Standard treatments, which include weight~     loss and medications to improve insulin secretion are only partly successful, and may~     require that young women take medications for decades.~      The study investigators have been evaluating the effects of specific diets on insulin~     resistance in healthy volunteers and subjects with type 2 diabetes, and have found that~     subjects with insulin resistance seem to respond particularly well to these diet regimens.~      Volunteers with PCOS are being asked to participate to see if following these diets can help~     regularize your menstrual cycles. The results of this study may help improve fertility~     treatments for women with PCOS.~   "
66256|NCT02190084|"~     Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of~     motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain~     and loss of dopamine, a type of neurochemical, in this part of brain results in apathy.~     Presence of apathy is linked to deficits in planning sequential tasks such as keeping a~     routine. Patients with apathy have poor physical function and their caregivers experience~     extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved~     the use of brain stimulation by a magnet known as repetitive transcranial magnetic~     stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to~     frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in~     AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will~     improve apathy and executive function better than sham treatment in those with AD.~   "
66257|NCT02190071|"~     The purpose of this study is to determine whether there is a difference of diagnostic~     accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients~     who were previously suspected of pancreatic cancer in radiologic test.~   "
66258|NCT02190058|"~     This is a randomised, double-blind, placebo-controlled multiple dose study designed to~     explore the safety, tolerability and PK of DS-1971a following oral administration over 14~     days to healthy male subjects.~   "
66259|NCT02190045|"~     Falls are a major public health problem. They are the leading cause of injuries and~     injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major~     reasons for falls in elderly. Exercise interventions improve gait and balance in the~     elderly. Despite the many proven benefits of exercise, many older adults in the US remain~     sedentary. This study targets at improving balance and gait with use of Wii-Fit as an~     exercise program.~   "
66262|NCT02190006|"~     Our study is observational, we are observing data from routine measurements during IVF/ICSI.~     Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI and~     preovulatory count which are calculated by observing routine measurements during the~     IVF/ICSI procedure.~      300 women with polycystic ovarian syndrome (PCOS) who are decided to be treated with ICSI.~     will be subjected to full history taking and clinical examination. On the second day of~     menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral~     follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined~     as the number of follicles measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by follicle stimulating~     hormone (FSH) stimulation until the day of Human chorionic gonadotrophin (HCG)~     administration.~      On the day of HCG administration, ovarian ultrasound scan will be performed using a~     transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is~     defined as number of follicles measuring≥16mm. Follicular output rate (FORT) will be~     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).~      FORT correlation to pregnancy will be compared to that of the preovulatory count number~   "
66263|NCT02189993|"~     The purpose of this study is to determine what the long term survival is after in hospital~     use of total parenteral nutrition due to intestinal failure.~      Earlier studies only followed patients for a maximum of 6 months or included only very~     specific patients. We were interested in all patients in our hospital and followed them for~     up to 2 years.~   "
66264|NCT02189980|"~     The purpose of this follow up study is to determine the duration of action regarding~     aromatherapy to treat nausea occurring postoperatively.~   "
66265|NCT02189967|"~     In this randomized multicentric phase II study it will be investigated whether an~     accelerated postoperative radiotherapy (7 fractions per week, 2 Gy single dose) may improve~     locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to~     conventional fractionation (5 fractions per week, 2 Gy single dose).~   "
66266|NCT02189954|"~     Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal~     morbidity linked to laryngeal mask use is related to correct choice of mask size, placement~     technique, placement of the laryngeal mask in the correct position on the larynx, cuff~     volume and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below~     45 mmHg (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to~     laryngeal mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after~     Laryngeal Mask Unique placement to limit pressure within the cuff can reduce this morbidity~     by nearly 70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a~     certain age group and cover stages including very young and middle-aged groups. In the~     literature only one similar study on the geriatric age group was found.~      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group~     with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal~     Mask cuff inflated without reference to pressure in the geriatric age group with indications~     for Laryngeal Mask Unique placement.~   "
66267|NCT02189941|"~     The purpose of this study was to evaluate the pharmacokinetic and safety profile of the~     sustained-release formulation of deferiprone under both fasting and fed conditions, and~     evaluate the relative bioavailability of this sustained-release formulation when compared to~     immediate-release formulation of deferiprone under fasting conditions.~   "
66268|NCT02189928|"~     Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first~     cause of acquired disability, and the 2nd cause of dementia and death. The only approved~     treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose~     objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few~     patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is~     mainly correlated to the final infarct size. The objective of neuroprotective treatments is~     to reduce the final size of the cerebral infarction.~      The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral~     ischemia by reducing the final size of cerebral infarction animal models. The per-CID~     corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member~     with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized~     control trial involving 250 patients within 6 first hours of myocardial infarction and~     candidate for primary angioplasty.~   "
66269|NCT02189915|"~     Study Purposes and Objectives:~      The objectives should be stated in such a way that the reader can determine the~     appropriateness of the study design. If appropriate, state the specific hypotheses being~     tested and/or study aims. Use lay language.~      Methamphetamine use is of great concern in the state of Utah because it's the primary drug~     of threat in the state, and is the primary drug of choice among females between the ages of~     18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine~     supplementation will result in improvements in depression rating scores in female MA users.~     Secondary hypotheses include the following: 1) creatine supplementation will result in a~     decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase~     after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal~     lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral~     supplementation.~   "
66270|NCT02189902|"~     The goal is to determine the vit D supplementation dose that safely results in optimal serum~     vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do~     this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol~     (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living~     in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D~     concentrations and efficacy to replete vit D status as determined by achieving a minimum~     serum 25D concentration of 32 ng/mL (80 nmol/L).~   "
66271|NCT02189889|"~     Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major~     health problem for patients having heart surgery. Hemoglobin is the part of our blood that~     carries oxygen from the lungs to the rest of the body. Anemia that is present before~     surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity~     (illness) and/or mortality (death) after heart surgery. It is also an important indicator of~     blood transfusion necessity. Recent clinical research investigations done to study~     preoperative anemia suggest a blood transfusion can damage the immune system (the system~     that protects us from disease) which can lead to infection, organ dysfunction (especially of~     the heart, kidney, brain), prolonged hospital stays, as well as increased supplies,~     resources and cost in surgical patients. Comprehensive anemia management can reduce or~     eliminate the need for blood transfusions and provide better outcomes after surgery.~     Therefore, controlling anemia before surgery is extremely important, and could be a~     lifesaving measure.~      This pilot, feasibility study is being done for several reasons. First of all, it will test~     the the safety and effectiveness of using a short-course of two medications, erythropoietin~     (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order~     to improve preoperative anemia, reduce transfusions and lower postoperative complications in~     anemic patients undergoing heart surgery. Secondly, findings will be used to design a large~     randomized controlled trial (RCT). The RCT will establish a protocol to actively manage~     anemia before surgery, thus reducing transfusions during surgery and improving recovery~     afterwards. It will also help identify valuable information regarding what needs to be done~     for timely completion of the planned RCT.~      EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia~     in patients with certain conditions in order to reduce blood transfusions. And although~     approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or~     vascular (blood vessels, including veins and arteries) surgery. Common side effects include~     nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis~     (blood clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement~     product approved for the treatment of low iron anemia in adult patients. It may cause~     serious allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as~     well as low BP and excessive iron storage.~      Patients meeting all eligibility requirements that consent to participate will be randomized~     into the study. Randomization is being placed by chance (like a flip of a coin) into one of~     two study groups, the treatment group or the control group. There is an equal chance of~     being placed into either group, which will be done by a computer.~        1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and~          a 510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And~          again 1-7 days before the day of surgery, a second dose of both of these medications~          will be given. The third dose, of EPO only, will be administered 2 days after surgery.~          Before initiating a dose or giving a subsequent dose, laboratory parameters will be~          measured to assess the hemoglobin level and response to the medication. If blood values~          increase too rapidly or are too high, the meds will not be started or, if already~          dosed, they will not be given again.~        2. The Control Group will receive no preoperative intervention for anemia unless lab~          results show iron deficiency anemia. The control group will be screened for the~          presence of iron deficiency anemia by evaluating blood laboratory values drawn during~          the baseline or preoperative visit. If lab results indicate iron deficiency anemia,~          over-the-counter oral iron will be recommended, to take until the day of surgery. In~          doing so, patients may benefit by potentially reducing the need for blood transfusions.~      Data will be collected from all participants from the preoperative visits throughout the~     admission, including lab results, medications, vital signs, information about the procedure,~     transfusions, and any problems or adverse events.~   "
66353|NCT02188823|"~     The study is a pilot, designed to provide data regarding the feasibility and acceptability~     of conducting such a study on a larger scale. The present study is a clinical trial~     assessing a programs to help people manage prediabetes and lose weight with a~     low-carbohydrate diet (LC) along with information about positive affect, mindful eating~     strategies, exercise, and sleep.~   "
67456|NCT02174380|"~     The purpose of this study is to determine the effectiveness and cost-effectiveness of a new~     population-based active case-finding program among adult household contacts of new~     infectious TB cases to detect active TB cases in the largest district, Lima, Peru.~   "
66272|NCT02189876|"~     The FemAALES Project is a community collaborative two-arm intervention designed to prevent~     HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and~     transmission among African American women and men by reducing sexual risk factors and~     enhancing sexual negotiation skills. The team of investigators is a collaboration of~     researchers and community service providers who are committed to developing prevention~     interventions that employ holistic and culturally relevant approaches. This includes~     recognizing the impact of forces such as racism, sexism, and gender expectations on~     individual behavior and relationship dynamics in African American communities. Specifically,~     the investigators hypothesis is that compared to the control condition the FemAALES~     intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection)~     incidence and will increase condom self-efficacy and risk behavior communication with sexual~     partners.~   "
66273|NCT02189863|"~     The overall objective of this study is to compare the effect on simulated driving~     performance of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late~     presbyopes.~   "
66274|NCT02189850|"~     The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a~     bowel preparation prior to colonoscopy in pediatric patients.~   "
66275|NCT02189837|"~     This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of~     evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.~   "
66276|NCT02189824|"~     A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells~     (microtransplantation) following consolidation chemotherapy in patients with AML that are~     not suitable for allogenic stem cell transplantation.~   "
66277|NCT02189811|"~     Poliomyelitis eradication has entered its last phase with only three remaining endemic~     countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2~     since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic~     polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge,~     and reported from several areas with low population immunity to polio, including in~     Pakistan. This study will provide data to National Immunization Authorities in order to make~     strategic decisions about their polio vaccination schedules in anticipation of the global~     tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus~     outbreaks.~   "
66278|NCT02189798|"~     The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing~     sensitivity can be preserved in newly implanted adults with partial deafness (considerable~     low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural~     hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™~     Mid-Scala electrode to support the development of electro-acoustic stimulation technology~     (EAS).~   "
66279|NCT02189785|"~     This project hypothesizes that the brain's opioid system determines rejection sensitivity, a~     personality trait that is a vulnerability factor and feature of several psychiatric~     disorders. This project will use positron emission tomography to measure the brain's opioid~     response to social rejection and acceptance in a nonclinical population with varying levels~     of rejection sensitivity. The results will provide the first major step towards~     understanding a neurotransmitter mechanism for rejection sensitivity, allowing for further~     investigation into predicting and treating its associated disorders.~   "
66280|NCT02189772|"~     The purpose of this study is to evaluate the safety and tolerability of a single~     administration of Metadoxine Extended Release (MDX) formulation for the treatment of~     adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will~     also try to evaluate the efficacy of MDX and its level in the blood.~   "
66281|NCT02189759|"~     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination~     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia~     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in term infants (greater than or~     equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.~   "
66282|NCT02189746|"~     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination~     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia~     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7~     weeks of gestational age) when compared with routine WHO thermoregulation alone.~   "
66283|NCT02189733|"~     The primary objective of the study is to evaluate the pharmacokinetic characteristics and~     demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab~     for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference~     liquid formulation of caplacizumab.~      The secondary objective of the study is to compare the safety and tolerability, and the~     pharmacodynamic parameters of the new formulation with those of the reference formulation.~   "
66284|NCT02189720|"~     The primary objective of the study is:~      • To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate~     therapy until the product becomes commercially available.~      The secondary objective of the study is:~      • To assess the long-term safety of amifampridine phosphate in patients with~     LEMS/CMS/downbeat nystagmus~   "
66285|NCT02189707|"~     To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal~     symptoms in adults with constipation.~   "
66286|NCT02189694|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose~     levels in children with type 1 diabetes in a diabetes camp.~      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent~     in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone~     closed-loop strategy, which in turn is more effective than the conventional pump therapy to~     reduce time spent in hypoglycemia~   "
66369|NCT02188615|"~     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown~     Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in~     terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell~     esophageal carcinoma.~   "
66287|NCT02189681|"~     Spinal anesthesia is widely performed using a surface landmark based 'blind' technique.~     Multiple passes and attempts while administering spinal anesthesia are associated with a~     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.~      Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the~     success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia~     has to date been limited to case series and case reports.Its use may be limited by the~     requirement for wide bore needles and the technical difficulties associated with~     simultaneous ultrasound scanning and needle advancement. The use of pre-procedural~     ultrasound has been shown to increase the first pass success rate for spinal anesthesia only~     in patients with difficult surface anatomic landmarks. No technique has been shown to~     improve the success rate of dural puncture when applied routinely to all patients. Routine~     use of pre-procedure ultrasound guided paramedian approach results in 50% reduction in~     number of passes required for spinal anaesthetic, from a study at Cork University Hospital~     (awaiting publication). L5-S1 is the widest interlaminar space and provides minimal~     contribution to overall movement of lumbar spine.This interspinous space might still be~     accessible even if the patient has minimal spine flexion. We also noted that spinal needle~     insertion via the L5-S1 interspace was associated with the fewest passes in the~     pre-procedure guided ultrasound group (although non-significant).~      We hypothesise that the routine use of pre-procedural ultrasound-guided paramedian spinal~     technique at L5S1 interspinous space will result in fewer needle passes to enter the~     subarachnoid space when compared to the conventional landmark based midline approach.~   "
66288|NCT02189668|"~     To determine if non-operative management with antibiotics alone is a feasible treatment~     alternative for pediatric patients with uncomplicated acute appendicitis with an~     appendicolith identified on imaging.~   "
66289|NCT02189655|"~     This prospective randomized double-blinded study was conducted to compare the antishivering~     effects of two different types of intrathecal administration.~   "
66290|NCT02189642|"~     The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care~     Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as~     intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators~     hypothesize quality of PACU outcomes will correlate with preoperative demographic and~     behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.~     This study will help the investigators improve post anesthetic care quality and create a~     higher level of satisfaction for patients, family, and health care providers.~   "
66291|NCT02189629|"~     Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of~     treatment on the face and trunk for acne vulgaris.~   "
66292|NCT02189616|"~     Asthma is the disease being studied. The main objective of this study is to assess the~     clinical efficacy of mobile phone short message service (SMS) reminder and consultation on~     the self-management and outcomes of poorly controlled asthma which is first diagnosed in a~     time period of 3 months. The secondary objective is to explore the cost-benefit and~     cost-effectiveness of the proposed intervention.~      Aims: The main aim of this study is to assist asthma patients to practice asthma~     self-management at home by sending reminders and responding to patients' consultations with~     mobile phone short message service (SMS), which will eventually help them to control their~     asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is~     to improve patient health outcome via enhancing patient-physician interaction through mobile~     phone short message service (SMS) that is low-cost and could be followed easily by the~     patients and their physicians.~      The hypothesis is that asthma patients who receive weekly text message reminders to educate~     them and reinforce adherence will have better asthma outcome, such as asthma control, while~     the intervention integrating patient consultation and reminders by SMS improve asthma~     outcome even more. The investigators further hypothesize that these subjects under~     intervention will have an improvement in secondary measures including quality of life and~     patient satisfaction. The investigators also anticipate that such an approach in asthma~     management will be cost-effective.~   "
66293|NCT02189603|"~     The purpose of this study is to determine the safety and immunogenicity of the recombinant~     hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E~     vaccine in this population.~   "
66294|NCT02189590|"~     The purpose of this study is to determine if there is a difference in time for successful~     fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.~   "
66295|NCT02189577|"~     The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate~     bromide) for the treatment of COPD patients.~   "
66296|NCT02189564|"~     The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is~     investigated in a single blinded parallel group design. Reward consists of performance~     dependent monetary reward, or of knowledge of performance in selected (above average)~     trials.~      The investigators hypothesize improved motor skill learning and higher involvement of the~     dopaminsrgic system under rewarding vs. non-rewarding conditions.~   "
66297|NCT02189551|"~     The objective of the study is to compare a new medical devices with an established medical~     device for lower limb rehabilitation regarding training outcome and patient comfort /~     patient satisfaction (primary objective) and treatment effect (exploratory objective).~      Primary study endpoints will be a significantly higher rated patient comfort and or patient~     satisfaction using the new versions, compared with the established Lokomat. Furthermore,~     muscle activity and kinematic movement patterns will be expected to show more involved~     muscle groups and a walking pattern involving more degrees of freedom during use of the new~     version compared with the established Lokomat.~      Exploratory endpoints will be a significantly stronger involvement of muscles needed for~     balance, more physiological walking patterns and more change on the lateral positioning of~     the feet due to training with the new version, compared with the established Lokomat.~   "
66357|NCT02188771|"~     This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial~     designed to assess the safety and tolerability of single intra-articular injection of~     RegenoGel-SP for the treatment of OA.~      RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The~     viscoelastic properties resulting from the combination of these two natural macromolecules~     is further enhanced by joint surface associated factors to generate a viscoelastic gel with~     superior stability and mechanical integrity.~   "
66298|NCT02189538|"~     Studies have shown that burn patients may benefit from low fat diets, but there is still no~     strong data regarding the impact of fatty acid composition used for feeding. The trial test~     the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome.~     Prospective randomised controlled trial in adult patients admitted for burns > 15% body~     surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral~     nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular~     enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study~     endpoints: mechanical ventilation time, inflammation (CRP), infectious and other~     complications, mortality until discharge.~      The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study,~     2) the study completed with information from the preliminary phase, both phases being~     randomised and controlled.~   "
66299|NCT02189525|"~     The purpose of this study is to evaluate blood-based biomarkers before and after~     sports-induced concussion using neuroimaging and head impact sensor technology.~   "
66300|NCT02189512|"~     The aim of this study is to study the impact of brain death and surgical small bowel~     manipulation on the release of different types of monocytes.~   "
66301|NCT02189499|"~     The purpose of this study is to evaluate the safety and feasibility of a new coronary artery~     stent for treating blockages in the arteries supplying blood to the heart muscle. The~     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the~     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away~     over time, leaving no permanent implant after the blood vessel has healed. This study will~     will be the first evaluation of this stent in humans.~   "
66302|NCT02189486|"~     Research repository designed to establish prostate cancer upgrading reference set and~     development of a risk prediction tool. Repository will include clinical information and~     biologics on a cohort of 600 men, to predict presence of high grade cancer at time of~     prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time~     of biopsy.~   "
66303|NCT02189473|"~     The primary aim of this randomized multi-center trial is to investigate the efficacy of the~     radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in~     patients with metastatic epidural spinal cord compression.~   "
66304|NCT02189460|"~     The purpose of this study is to understand the effect of age on language abilities. The~     investigators aim at investigating the cerebral modifications that take place in normal~     aging, at the functional an anatomical level.~   "
66305|NCT02189447|"~     Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking~     in patients with keratoconus~   "
66306|NCT02189434|"~     Serum procalcitonin levels will be considerably higher, for a longer period of time, in~     patients who develop sepsis compared to patients with SIRS or those who have an~     uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow~     for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current~     standard ICU methods.~   "
66307|NCT02189421|"~     The aim of this study is to evaluate the usefulness of a newly developed multibending~     ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without~     assisting accessory in comparison with conventional ultra-slim endoscope. The investigators~     expect that multibending endoscope will show more higher successful performance than~     conventional endoscope.~   "
66308|NCT02189408|"~     The purpose of this study is to investigate reduction of pain, gain of function and~     improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during~     knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized-~     controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months~     and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.~   "
66309|NCT02189395|"~     The goal of the current study is to determine difference in glycemic control between~     traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs~     basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly~     encountered in the investigators county hospital setting which include newly diagnosed type~     2 patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight.~     Primary outcome of the study is to determine differences in glycemic control between~     treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure~     number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.~   "
66310|NCT02189382|"~     This study will compare the safety and effectiveness of a potassium oxalate desensitizer or~     negative control on dentinal hypersensitivity.~   "
66311|NCT02189369|"~     This clinical validation study is being carried out to validate the efficacy of a test~     measuring the clinical application of prostaglandins present in the endometrial fluid in~     patients, 24 hours before the embryonic transfer. This test is capable of predicting~     endometrial receptivity without the need of performing a biopsy.~   "
66312|NCT02189356|"~     The aim of this study was to evaluate the effect of exercise programs on pregnant women with~     pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise~     programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote~     functional capacity for pregnant women with LBPP.~   "
66313|NCT02189343|"~     To determine the maximum tolerated dose (MTD), if present, and dose schedule of ACY-1215~     (ricolinostat) in combination with pomalidomide and low-dose dexamethasone in patients with~     relapsed-and-refractory multiple myeloma.~   "
66314|NCT02189330|"~     All subjects in this study will be given tafamidis. After swallowing a single pill of~     tafamidis, measurements including blood samples will be compared to see if tafamidis made in~     different ways is about the same. After approximately 28 days subjects will be given another~     pill of tafamidis and the study measurements will be repeated.~   "
66354|NCT02188810|"~     This is a phase 1, research study is looking at the safety and acceptability of a new~     vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine~     (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy~     volunteers.~      The study will enroll approximately 48 healthy adult participants, and occur over 3 years.~     In the first six months/180 days of the study participants will have visits to the study~     site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year~     3, participants will be contacted by telephone or email to collect information on any~     adverse events.~   "
66315|NCT02189317|"~     This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine~     Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps~     tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.~     Patients will be randomized into treatment and control arms. The treatment arm will include~     40 patients receiving liposomal bupivacaine intra-operatively in addition to the current~     standard pain control regimen. The control group will include 40 patients receiving the~     standard post-operative pain control regimen. Patients will be assessed to identify~     differences in post-operative pain, satisfaction, as well as concomitant pain medication~     use. Post-operative range of motion will also be assessed.~   "
66316|NCT02189304|"~     This is a single-center, Phase I, healthy adult subject study with a randomized, double~     blind, three period, three-treatment, cross-over design.~   "
66317|NCT02189291|"~     Objectives~      The objective of this study is to help identify the best practice regarding the use of~     indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a~     randomized controlled trial comparing the immediate removal of indwelling urethral catheter,~     after minimally invasive sacrocolpopexy, to the present standard catheter removal on post~     operative day one. Evidence based catheter management will be helpful to both providers and~     patients in post-operative decision making.~      Specific Aims~      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.~      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy confers no increased risk of re-catheterization.~      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy decreases the occurrence of urinary tract infection.~      Design~      A randomized controlled trial comparing the standard overnight indwelling urethral~     catheterization with removal of catheter immediately post surgery after minimally invasive~     sacrocolpopexy, at Oregon Health & Science University.~      Outcome measures~      Primary outcome measures are hospital stay in hours after completion of surgery and need for~     re-catheterization. Hospital stay will be counted from the time the patient leaves the~     operating room to the time she leaves the hospital. To avoid confounding, investigators are~     only including the first / morning case of the day. For re-catheterization, investigators~     will evaluate if patient was able to void after completion of surgery. Investigators will~     compare the post voiding residuals, the need for re-catheterizations and the numbers of~     patients going home with an indwelling catheter between the two groups. Investigators will~     also compare the number of urinary tract infections, as documented by urine culture and~     subsequent treatment, between the two groups.~      Study Subjects~      Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be~     invited to participate in the study during their preoperative visit. If they agree to~     participation, this will be noted in their chart. Randomization to group will occur~     immediately following surgery.~   "
66318|NCT02189278|"~     Evidence-based guidelines recommend cancer surveillance procedures for breast cancer~     survivors including physical examination, mammography, breast self-exam, and gynecologic~     follow-up. The early detection of recurrent and new cancers can best be achieved through the~     combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55%~     of breast cancer survivors do not undergo these procedures as recommended. This study tests~     a telephone-based psychosocial intervention aimed at improving adherence to recommended~     surveillance in breast cancer survivors. The psychosocial intervention for improving~     adherence is compared to treatment as usual.~   "
66319|NCT02189265|"~     The purpose of this study is to investigate whether there has been a change in perinatal~     outcomes following the phased smoking ban introduction (January 2004 for workplaces; July~     2008 for bars and restaurants) workplaces in the Netherlands.~   "
66320|NCT02189252|"~     This is a randomized, open-label crossover study. The primary objective of this study is to~     compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid~     (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a~     single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.~   "
66321|NCT02189239|"~     The objective of the STRESS trial is to investigate in a mode of action setting the effect~     of Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after~     acute stress in healthy male volunteers. In addition, data on safety and tolerability of~     Zeller Entspannung will be obtained.~      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers~     will be included into this randomized, double blind study. Study duration will be 7 days,~     study medication intake will be over 4 days: participants will take the medication one~     tablet three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only~     two tablets will be taken (morning and midday).~   "
66322|NCT02189226|"~     The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser~     endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin~     of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).~   "
66323|NCT02189213|"~     1 out of 8 children, adolescents, and young adults suffer from an anxiety disorder. Studies~     over the past decade show that selective serotonin-reuptake inhibitors (SSRIs), a class of~     medication that treats anxiety in adults, also works well in young adults, children, and~     adolescents with anxiety disorders, but only for about 50%. 50% will have undergone~     treatment for several months before it will be established that the medication is not~     working to treat the anxiety. The purpose of this study is to find a test that will predict~     treatment outcome from the beginning based on behavioral and biological measures.~   "
66324|NCT02189200|"~     Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to~     genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of~     adverse events with statins, added to recent questions about their benefits on hard~     outcomes, opens a gap for the importance of seeking other forms of treatment of~     dyslipidemia, particularly in patients for secondary prevention. The consumption of oat~     bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption~     of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides,~     phytochemical compounds with alleged antioxidant in lipid membranes, can be effective~     strategy for secondary prevention of atherosclerotic disease.~   "
66325|NCT02189187|"~     The goal of this project is to characterize changes in emotion regulation pathways~     associated with healthy behaviors in people who have recently lost weight and are seeking to~     maintain weight loss over a 1-year period.~   "
66326|NCT02189174|"~     To estimate the maximum tolerated dose (MTD) or recommended dose for phase II (RP2D) of~     CLR457 and to investigate the anti-tumor activity of CLR457~   "
66327|NCT02189161|"~     Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency~     ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).~     Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA~     will be applied using the Barrx™ Ablation System.~   "
66355|NCT02188797|"~     The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered~     risk reduction program for homeless young adults. It is hypothesized that youth who~     participate in the program will show greater reductions in substance use intentions,~     behavior and consequences, as well as sexual activity intentions and risk behavior, over a~     3-month period compared to a usual care control sample of youth who do not participate in~     the program.~   "
66328|NCT02189148|"~     Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal~     outcomes, including fetal growth restriction and perinatal death. Several measures are used~     or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid,~     among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who~     could benefit from those preventive measures are not identified until late in pregnancy.~     Recent evidences suggest that the investigators could identify women at risk of developing~     preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester~     of pregnancy. This screening test needs external validation. A first-trimester screening~     strategy will strengthen clinical research on preeclampsia and will contribute to the~     development of strategy combining the prediction and prevention of the disease and its~     related complications.~   "
66329|NCT02189135|"~     Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of~     illness, disability, and death in Malaysia with an increasing prevalence. Despite the best~     effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2~     diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk~     of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM~     Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at~     sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will~     generally consume large quantities of fried and sugary foods when they break their fast or~     during the night. Given the importance and public health significance of poor diabetes~     management and its associated risk especially during Ramadan, the investigators aim to test~     the intervention of using remote monitoring within community provider practice for patients~     with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer~     which can directly feedback the patients glycaemic levels to the physicians will reduce and~     even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain~     euglycaemic throughout the whole Ramadan month.~   "
66330|NCT02189122|"~     The investigators will compare the effects of rapid release aspirin and NHP-544C on the~     prostacyclin response to intravenous bradykinin.~   "
66331|NCT02189109|"~     This clinical trial is testing the safety, tolerability and effectiveness of NVX-108~     administered via intravenous infusion in combination with standard radiation and~     chemotherapy.~      NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is~     hoped to increase the effectiveness of radiation therapy.~   "
66332|NCT02189096|"~     Sepsis claims over 37,000 lives in the United Kingdom each year- more than lung cancer, and~     more than breast cancer, bowel cancer and HIV/AIDS combined. Less than two-thirds of~     patients who develop sepsis will survive. Sepsis can affect a person of any age, social~     background, and can strike irrespective of underlying medical conditions.~      An important element in improving the care of patient with sepsis is early identification~     and early intervention, both of which have been shown to improve outcomes. Physiological~     deterioration often precedes clinical deterioration as patients develop critical illness.~     Recognition of this has led to the development of Early Warning Score (EWS) systems which~     allow earlier identification of physiological deterioration. By assigning numerical values~     to various physiological parameters, a composite score can be assigned to a patient,~     allowing early identification of patients who are at risk of critical illness.~      EWS were initially developed to assist in the management of patients in the general ward~     setting. A recent study has shown that an increased EWS on arrival at the Emergency~     Department (ED) is associated with higher odds of adverse outcome amongst patients with~     sepsis. Consequently, the use of EWS could facilitate patient pathways to ensure triage to a~     high acuity area of the ED and senior clinician involvement at an early stage. The use of a~     standard single National EWS (NEWS) across the National Health Service in the United Kingdom~     has been recommended to improve patient care.~      NEWS also lends itself to extension to pre-hospital care and ambulance services. Most~     ambulance services routinely collect the physiological data required to calculate a NEWS~     score and indeed some ambulance services have incorporated this into electronic patient~     record forms (ePRF). An agreed NEWS score of greater than a specific level could be used as~     a trigger for ambulance service pre-alert of a receiving ED.~      Point of care measurement of lactate has also been shown to be feasible in the ED. Serum~     lactate is recognised as an independent predictor of mortality in sepsis and there may be~     potential for combining NEWS systems and point of care to further improve diagnostic~     accuracy for patients at risk of adverse outcomes.~      In this study, we aim to apply the use of early warning scores and point of care testing to~     a cohort of all ambulance patients to assess the feasibility and utility of this approach.~   "
66333|NCT02189083|"~     On the basis of empirical evidence and clinical practice, the investigators have developed a~     formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids~     (UFs). The investigators preliminary clinical observation has demonstrated the benefits of~     TSD in improving UFs.~      TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis,~     Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina~     draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with~     vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.~      It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms~     associated with UFs and the greater anti-tumor potency of TSD is associated with higher~     therapeutic doses.~      To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be~     conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of~     TSD could produce significantly greater effects in reducing the fibroid size and improving~     its related symptoms and biochemical profiles compared to the lower dose (69 g/day).~   "
66334|NCT02189070|"~     The purpose of this study is to determine the preference of patients regarding the approach~     for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that~     patients prefer questionnaires for annual follow-up assessment when compared to telephone or~     email.~   "
66335|NCT02189057|"~     The overall goal of this investigator-initiated trial is to evaluate the treatment outcome~     of depression utilizing platform algorithm products that can allow rapid identification of~     pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may~     have the potential to optimize treatment selection by improving response, minimizing~     unfavorable adverse events / side effects and increasing treatment adherence.~   "
66356|NCT02188784|"~     The purpose of this study is to determine if oral iron (FE) polysaccharide is superior to~     oral placebo in improving functional capacity as measured by change in peak VO2 by CPET~     (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart~     Failure Exercise Testing) and Fe deficiency at 16 weeks.~      Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral~     placebo, therapy with oral Fe polysaccharide will be associated with improvement in~     functional capacity at 16 weeks as assessed by CPET.~   "
66370|NCT02188602|"~     The investigators would like to investigate the effect of chloride dosing on the development~     of acute kidney injury in critically ill patients. The investigators hypothesis is that~     administering intravenous fluids with higher chloride content are more likely to lead to~     acute kidney injury.~   "
66336|NCT02189044|"~     Introduction: Among the systems of the organism, it is believed that the respiratory system~     is the one which gets older faster due to the greater exposure to environmental pollutants~     over the years.The Pilates method has emerged as a form of fitness particularly providing~     general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises~     on respiratory muscle strength in elderly women. Methods: The investigators have studied 07~     women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function~     Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory~     muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP)~     and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment~     lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations,~     the investigators applied the paired t test and a significance level of 5%.~   "
66337|NCT02189031|"~     Upper limb amputation is a devastating injury that leaves many thousands of typically young~     and active individuals in the US to rely on artificial arms and hands to help restore their~     lost function. The investigators research is focused on helping these individuals to feel~     where their prosthetic limbs are moving without having to look at them by developing devices~     and approaches to provide sensory feedback of limb movement through the nerves that once~     served the missing limb.~   "
66338|NCT02189018|"~     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs~     and decreased blood flow to the legs. This may cause difficulty or pain with walking or~     other activities that use leg muscles. Exercise may help improve blood flow in the legs and~     improve the ability to walk. This research project is being implemented in adults with PAD~     to examine the effects of exercise or weight loss programs on lower extremity blood flow,~     health, and physical function.~   "
66339|NCT02189005|"~     The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with~     higher than normal blood sugar levels.~   "
66340|NCT02188992|"~     Between 6 and 16% of patients presenting to hospital emergency departments have infections,~     with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue~     is that, at time of presentation, it can be difficult to determine who has inflammation as a~     result of infection and who does not.~      Some of the patients with infections will deteriorate to organ failure ('severe sepsis')~     including failure of the heart and blood vessels to maintain normal blood pressure ('septic~     shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated~     with a significant mortality, which can be reduced by early intervention. However~     identifying those patients who are at high risk of deteriorating to septic shock can be~     difficult on initial presentation to hospital, and thus these patients risk being 'triaged'~     to an inappropriate level of care and/or missing the crucial early interventions which can~     modify mortality. Equally failure to identify which patients have underlying infections can~     lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory~     tests are often unable to accurately identify those patients with infection, and those who~     are likely to deteriorate to severe sepsis and septic shock.~      Investigators in this group have recently identified several signatures of immune system~     activation which predict those patients who are likely to deteriorate, and which patients~     with suspected infection subsequently have this confirmed. Such tests would have major~     benefits for the management of patients with early suspected infection and sepsis if they~     can be translated into a test usable in everyday clinical practice. This study aims to~     determine the prevalence of these markers in a cohort of patients admitted with suspected~     sepsis, and their predictive ability for developing established septic shock. From this~     investigators aim to derive an optimal test, to be tested in a validation cohort~     (ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the~     next step towards developing a market-ready test.~      Study hypothesis is:~      Measurement of markers of immune activation will allow i) Risk stratification for~     deterioration into severe sepsis ii) Risk stratification for death amongst patients~     presenting with sepsis iii) Identification of patients with confirmed sepsis~   "
66341|NCT02188979|"~     BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy~     occurs frequently in obese patients. We investigated the incidence of DTI using the~     GlideScope® videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment~     with the El Ganzouri Risk Index (EGRI).~      METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing~     abdominal surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation~     (FFBI) or GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome~     was the occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III,~     Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS)~     was also used. Secondary outcomes included intubation success during the first attempt, the~     time to Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen~     desaturation and difficult ventilation.~   "
66342|NCT02188966|"~     In the Emergency Department Regional Hospital Horsens a monitor will display Geographical~     Information System data (GIS data) for all ambulances with the hospital as final~     destination. The location, estimated time of arrival (ETA) and urgency code for the~     ambulances will be showed. Furthermore the patient's name, personal identification number~     and the primary message received by the emergency medical dispatch center resulting in~     ambulance dispatch will be displayed. This may enable the coordinating nurse to optimize~     timing of the ad hoc trauma team and medical emergency team activation. The teams are~     activated if the patient's condition is assessed to be of the highest urgency and/or~     severity - triage 1 or red. The coordinating nurse makes this assessment on the basis of~     information from the ambulance personnel and makes the decision to activate the team and~     when to do it. In this study the investigators want to examine if the availability of GIS~     data in the emergency department results in reduced waiting time for the members of the~     trauma team and medical emergency team. The study will be conducted as a before and after~     study.~   "
66343|NCT02188953|"~     The purpose of this study is to pilot test the effectiveness, acceptability, and~     palatability of ACCS100 in a high-risk Kenyan population.~   "
66344|NCT02188940|"~     Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life~     and a reduced response to inhaled corticosteroid medication compared to non-obese~     asthmatics. In addition, the impact of a weight-loss program on clinical control and~     psychological outcomes has been poorly demonstrated and the effect of exercise training~     remain unknown. The investigators aim to investigate the effect of exercise training in a~     weight-loss program on asthma clinical control (primary outcome), health factors related to~     quality of life and psychosocial symptoms (secondary outcomes) in obese patients with~     moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep~     disorders will also be evaluated. The investigators' hypothesis is that exercise as part of~     a weight-loss program is more effective to lose weight and improve asthma control, quality~     of life and psychosocial symptoms in obese asthmatics.~   "
66358|NCT02188758|"~     The goal of this study is to identify chemical compounds in the blood and sputum (i.e.,~     biomarkers) that are associated with objective measurements of health status in patients~     with cystic fibrosis (CF). This study builds upon observations that blood levels of~     hepcidin-25, a protein that regulates how the body uses and stores iron, vary during CF~     pulmonary exacerbation (CFPE).~   "
66345|NCT02188927|"~     Participation in a primary screening colonoscopy programs remains low. Advanced notification~     letter has been shown to increase participation in colorectal cancer screening with fecal~     occult blood testing and to be cost effective compared to standard invitation. It is unknown~     whether advanced notification letter increases participation rate in primary colonoscopy~     screening program.~      We hypothesize that an Advance Notification Letter will have significant influence on~     participation in screening colonoscopy, comparing to standard invitation procedure and will~     thus result in higher efficiency of the program.~      This randomized controlled study aims to compare the participation rate in screening~     colonoscopy in response to advanced notification plus standard invitation letter and~     standard invitation letter alone.~      Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population~     Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy~     with advanced notification letter (send two weeks before standard invitation) plus standard~     invitation (send six weeks before planned screening colonoscopy) or to standard invitation~     only (send six weeks before planned screening colonoscopy). The sample size was calculated~     to detect 3% difference in participation rate between the groups (25% vs 28%) with 80%~     power.~   "
66346|NCT02188914|"~     Inhalants substance misuse is an important public health problem whose prevalence is~     approximately 1% in the general population and 7% among high school students in Mexico.~     Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,~     2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition~     (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based~     inhalant substance leading to clinically significant impairment or distress. There are~     studies to suggest that long-term exposure to inhalants is associated with structural brain~     abnormalities, as well as neuropsychological impairments. However many of these studies have~     been limited to the gross anatomical report, therefore is necessary the use of complimentary~     techniques which provide a better understanding of brain. To the date there is no evidence~     of the use of positron emission tomography, and there are few studies have employed other~     magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used~     to know the metabolic activity and white matter tract integrity respectively in inhalant use~     disorder participants. The purpose of this study is evaluates the effects of the inhalant~     use disorder in the brain. The investigators will be using positron emission tomography~     (PET), Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this~     study will examine the impact of inhalants consumption on executive function performance and~     the transcriptomic changes associated with inhalants consumption. The investigators hope~     that the data gathered from this study will lead to the development of more effective~     treatments~   "
66347|NCT02188901|"~     B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma~     (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast~     agent for ultrasonography, has reported to have superior sensitivity in detecting focal~     liver lesion since it has ability of Kupffer phase imaging as well as vascular phase~     imaging. So our aim is to compare the detection rate of early stage HCC and false referral~     rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same~     prospective data group. Our hypothesis is that S-US has superior detection rate of early~     stage HCC (5%) than that of B-mode US (3%).~   "
66348|NCT02188888|"~     Clinical study suggests that beta-blockers by decreasing heart rate together with an~     increase in stroke volume do not negatively affect cardiac output allowing an economization~     of cardiac work and oxygen consumption in patients with septic shock. Whether this~     hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The~     objective of the present study is therefore to elucidate whether a reduction in heart rate~     with esmolol is associated to an improvement of cardiac efficiency in patients with septic~     shock who remained tachycardic after hemodynamic optimization.~   "
66349|NCT02188875|"~     Previous studies suggest self-regulatory techniques including self-monitoring, and SMS~     text-messaging as an intervention modality, can modify health behaviors including physical~     activity (PA). The primary purpose of this study was to examine change in objectively~     measured PA in a randomized controlled pilot trial that tested a wearable sensor/device~     (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in~     overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One~     and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided~     to facilitate self-monitoring with a wearable tracker for instant feedback and website of~     daily PA summaries. Outcome measures were number of steps and minutes of PA by~     intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week~     follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that~     text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA~     compared to only the Fitbit One at 6-week follow-up.~   "
66350|NCT02188862|"~     The purpose of this study is to investigate whether there are genetic differences between~     patients with rheumatic heart disease and members of the general population.~   "
66351|NCT02188849|"~     To determine, in a double blind trial, the effects of creatine supplementation during 12~     weeks on muscle mass and function of community living older women subjected to resistance~     training. Material and methods: Fifty healthy older women will be selected for the study.~     All participants will be subjected to a progressive resistance training program using~     elastic bands and weights, consisting in three sessions per week lasting 1 hour. Participant~     will be randomly allocated in a double blind fashion, to receive creatine 5 g per day or an~     identical placebo. The training and supplementation period will last 12 weeks. At baseline~     and at the end of the study, body composition will be measured by dual energy x-ray~     absorptiometry, rectus femoris cross sectional height and surface will be measured by~     ultrasound, quadriceps strength will be measured in a quadriceps table and 12 minutes' walk~     will be assessed. The main outcome measure will be quadriceps cross sectional height.~     Expected results: We expect that creatine supplementation will increase rectus femoris~     height over and above the effect of resistance training.~   "
66352|NCT02188836|"~     This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal~     femur fractures using a device developed by the investigators.~      The hypothesis is that patients with femoral diaphysis treated with the electromagnetic~     stimulation have less non-union after six months than patients treated with a placebo~     device.~   "
66359|NCT02188745|"~     Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor~     (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems~     counterintuitive since anti-estrogens block ER function, while estrogens increase ER~     function, but these therapies are effective to similar extents for the treatment of~     metastatic ER+ breast cancer. Estrogen therapies are most effective against cancers that~     develop resistance to anti-estrogens, likely because such cancers have adapted to grow~     without ER function, and restoring ER function (with estrogen) is damaging to the cancer~     cells. In some patients with ER+ breast cancer that becomes resistant to anti-estrogens,~     treatment with the estrogen 17b-estradiol induces tumor response. Furthermore, when~     17b-estradiol-sensitive tumors eventually become resistant to 17b-estradiol, switching back~     to anti-estrogen therapy is often effective. These observations suggest that cancers can~     alternate between anti-estrogen-sensitive and 17b-estradiol-sensitive states. The~     investigators hypothesize that treatment with alternating 17b-estradiol / anti-estrogen~     therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth~     than continuous treatment with either type of therapy in patients with metastatic~     anti-estrogen-resistant ER+ breast cancer.~   "
66360|NCT02188732|"~     This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and~     medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone~     (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also~     receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3~     hypotheses:~      Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater~     health self-management and greater mental health self-management.~      Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater~     reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.~      Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less~     acute service use and less acute service use costs.~   "
66361|NCT02188719|"~     The purpose of this study is look at the safety of:~        -  Taking a specific combination of immunosuppressant drugs after liver transplantation~        -  Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells~          (darTregs) while taking this specific combination of drugs~   "
66362|NCT02188706|"~     The goal of this clinical research study is to compare the response rates of patients~     receiving decitabine alone, decitabine with carboplatin, and decitabine with arsenic~     trioxide in patients with AML or MDS.~   "
66363|NCT02188693|"~     The primary purpose of our study is to evaluate whether gemcitabine as a single agent is~     superior to observation in improving progression-free survival (PFS) in patients with~     metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG~     as their first-line treatment~   "
66364|NCT02188680|"~     The patients having a syndrome SII would be more intolerant in the fructose than the healthy~     subjects and would benefit from a fructose diet but also from the fructans which contain~     some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test~     after absorption of fructose. However, the eviction of the fructose is sometimes recommended~     to the patients without having realized beforehand the test of intolerance.~   "
66365|NCT02188667|"~     The purpose of this study is to assess the impact of clinician education, electronic health~     record integrated patient reported outcomes, and electronic health record integrated~     decision support on pain-related care quality, outcomes, and service utilization.~   "
66366|NCT02188654|"~     Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in~     PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic~     inflammation and proinflammatory cytokines. Clinical observations and experimental results~     argue for an anti-inflammatory and immunosuppressant property of MET.~   "
66367|NCT02188641|"~     Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in~     association with psoriasis. PsA patients have a higher prevalence of comorbidities including~     obesity, metabolic syndrome, depression and premature cardiovascular disease. There is~     evidence that obesity is associated with PsA. A 12 month study was conducted to determine~     whether exercise and dietary weight loss are more efficacious, either separately or in~     combination, than standard care alone in improving symptoms and signs in obese adults with~     PsA.~      Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients~     were randomized into usual lifestyle (controls), diet only, exercise only, and diet plus~     exercise groups for 12 months. Disease activity was assessed. Blood samples collected after~     12 hours overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP,~     proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6)~     and interleukin-17 (IL-17). The primary outcome measures included improvement in ACR20.~     Secondary endpoints included reduction in PASI score, DAS28-CRP response and physician and~     patient global assessment (PGA). Safety and tolerability were also assessed. Data was~     collected at baseline and every 6 months.~   "
66368|NCT02188628|"~     Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in~     Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the~     stroke survivors will require specialized rehabilitation. In recent years, robot-aided~     therapy has been proposed as a means of complementing traditional therapy to alleviate the~     burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens~     of robots have been proposed in the literature but only half a dozen have been~     commercialized and typically none are seen in local clinics, due to exceedingly high costs.~     A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and~     developed at NTU for experiments in motor control neuroscience. The H-man can generate~     computer-controlled force fields to assist or resist a subject's motion and is potentially~     an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of~     the H-Man is available at NTU.The primary aim of this proposed project is to assess to what~     extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility~     pilot clinical trial design involving stroke survivors. The investigators believe that H-Man~     can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor~     incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians~     at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will~     be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized~     Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a~     pared down home use model will be assessed in 4 subjects.~      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit~     clinically significant decreases of impairment when training with the H-Man combined with~     standard arm therapy on robot-measured scales and standardized clinical scales, at the level~     of elbow/shoulder after 18 sessions of training on the H-Man.~   "
66371|NCT02188589|"~     To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate~     to severe nasal valve collapse.~   "
66372|NCT02188576|"~     This research study is being performed to evaluate two different doses of Tranexamic acid~     (TXA) in children who have craniosynostosis and have been referred to Boston Children's~     Hospital for corrective surgery. This surgery is associated with significant blood loss and~     frequently requires the transfusion of blood. TXA is a medication that reduces the amount of~     bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an~     FDA-approved drug that is routinely used in infants and children undergoing major surgery~     including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to~     decrease both the amount of bleeding and the amount of blood transfusion needed. We would~     like to compare the different doses of TXA to see if a lower dose has the same effect on~     blood loss as a higher dose. We are also interested to learn why TXA seems to work better in~     some patients than in others. In order to study the effect of this drug we would like to~     give this drug to your child and measure the blood loss and the volume of blood given to~     your child during his/her surgery.~      The research is being done at two sites; Boston Children's Hospital and Gaslini Children's~     Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan~     Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this~     study.~      We are planning to study a total of 68 infants and children from age 3 months to 6 years old~     scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini~     Children's Hospital.~   "
66373|NCT02188563|"~     Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and~     neck) and negatively impacts survival and other outcomes, but many patients have difficulty~     quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far~     have had limited success. This is a pilot randomized controlled trial designed to determine~     if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates~     for cancer patients who smoke.~   "
66374|NCT02188550|"~     The purpose of the study is to determine if the combination of Everolimus and Letrozole is~     effective in the treatment of women with either recurrent or persistent epithelial ovarian,~     fallopian tube, primary peritoneal or endometrial cancer.~      Experiments have shown that everolimus (Afinitor®) can prevent cells such as cancer from~     growing in number. Therefore, everolimus (Afinitor®) is being tested in specific diseases to~     stop cells from growing too fast (as in cancer).~      Everolimus (Afinitor®) has been FDA approved for adults with advanced kidney cancer (Renal~     Cell Carcinoma). Everolimus (Afinitor®) received approval for patients with subependymal~     giant cell astrocytoma (SEGA), a brain tumor seen with genetic conditions called tuberous~     sclerosis complex (TSC) who require therapy, but are not candidates for surgery. Everolimus~     (Afinitor®) was approved for pancreatic neuroendocrine tumor (PNET) in patients with~     unresectable, locally advanced, or metastatic disease. Everolimus (Afinitor®) received~     approval for the treatment of postmenopausal women with advanced hormone receptor-positive,~     HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure~     of treatment with letrozole or anastrozole. Everolimus (Afinitor®) also received approval~     for the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate~     surgery.~      Everolimus (Afinitor®) has been used to treat patients in clinical studies since 2002 and~     approximately 25,645 patients (as of 30-Sep-2012) have been treated with everolimus~     (Afinitor®).~   "
66375|NCT02188537|"~     Trial objectives:~      To decide whether the addition of nelfinavir to the approved antimyeloma therapy with~     bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant~     myeloma patients to merit further clinical investigation in a prospective controlled trial.~      Additional research questions:~      To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the~     assessment of the biology of proteasome inhibitor resistance and the identification of~     predictive markers for response to nelfinavir-based antimyeloma therapy.~   "
66376|NCT02188524|"~     For the duration of 10 weeks, participants will be asked to maintain their current levels of~     physical activity and to take part in three testing sessions over the course of 10 weeks.~     Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and~     after the intervention terminates (week 10). The objective measurements will be taken by~     inserting pressure sensors directly into the shoe and recording the centre of pressure.~     Markers will be attached to the surface of the body on the shoulders, feet and belly button~     and video recording will be used to assess the movement of the centre of mass. The first~     task requires individuals to stand in one spot with their eyes open, and then eyes closed.~     Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as~     fast as possible. Lastly, participants will walk around a set of chairs while music plays~     and when the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires~     participants to rise from a seated position, walk 3 meters, turn and return to their~     original seated position. The Berg Balance Scale requires the completion of a 14 task~     sequence which evaluates balance ability during seated, and various standing positions as~     well as transitioning movements. The other measurements taken are collected via a~     questionnaire about balance confidence level. Upon arrival, participants are required to~     report whether they have experienced a fall since the last class attended and if yes, a~     follow-up questionnaire is also required to gain information about the nature of the fall.~   "
66377|NCT02188511|"~     E-cigarettes are an increasingly popular alternate nicotine delivery system, but nothing is~     known about the effects of electronic cigarettes on the lungs. We hypothesize that~     e-cigarettes disorder airway epithelial and alveolar macrophages biology. Our goal is not to~     carry out a large epidemiologic study of electronic cigarette users to study lung function~     and other possible abnormal clinical phenotypes, but rather to focus on whether electronic~     cigarette smoke disorders the biology of the lung cells first exposed to the electronic~     cigarette smoke, a parameter that is the precursor of abnormalities in lung function and~     which is far more sensitive than lung function.~   "
66396|NCT02188264|"~     This phase I/Ib trial studies the side effects and best dose of selumetinib when given~     together with cyclosporine in treating patients with solid tumors or colorectal cancer that~     have spread to other places in the body and cannot be cured or controlled with treatment.~     Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as cyclosporine, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop tumor~     cells from growing. Giving selumetinib and cyclosporine may be a better treatment for solid~     tumors or colorectal cancer.~   "
66378|NCT02188498|"~     The objective of this study is to determine if a non-invasive technique, using an innovative~     analysis of electrocardiogram (ECG) data, would allow for detection of respiratory events~     during sleep and discrimination between central and obstructive apnea. Obstructive Sleep~     Apnea (OSA) is the most common respiratory disturbance seen during sleep, with an estimated~     prevalence of 10 % in the population and is strongly associated with the development of~     cardiovascular disease. In patients with underlying cardiac disease, particularly in heart~     failure (HF), central respiratory events such as Cheyne-Stokes Respiration (CSR) are often~     seen during sleep. The presence of CSR is also associated with increased cardiovascular~     morbidity and mortality. Currently, the identification and classification of sleep related~     respiratory disturbances is performed during over-night sleep studies (polysomnography),~     which are labor-intensive, time-consuming, expensive and difficult for patients. Thus, the~     development of alternative techniques to assist in the identification of those events in the~     outpatient setting is of marked importance for widespread screening of sleep apnea.~   "
66379|NCT02188485|"~     With the long-term goal of improving interventions for late-life suicide, the purpose of~     this study is to examine whether a mechanism by which behavioral interventions reduce risk~     for late-life suicide is by increasing social connectedness. The investigators propose to~     examine whether a manualized intervention that targets connectedness--ENGAGE--increases~     connectedness in older adults who report clinically significant depression and~     disconnectedness—operationalized as feeling lonely and/or like a burden on others. The~     investigators propose a randomized controlled trial comparing the ENGAGE intervention with~     care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social~     disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression.~     At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social~     connectedness, depression, and suicide risk. The investigators hypothesize that those~     subjects assigned to ENGAGE will report greater increases in connectedness—measured as~     greater belongingness and lower burdensomeness—compared to CAU; that ENGAGE will produce~     greater reductions in depression and suicide ideation than CAU; and that changes in~     depression will be accounted for changes in social connectedness.~   "
66380|NCT02188472|"~     The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and~     trimethoprim's possible induction of oxidative stress in human cells. The induction is~     examined by comparing changes in oxidative stress in the treatment group with the change in~     a placebo group. The study is a randomized-based placebo-controlled study. Each treatment~     group consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim~     or placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and~     8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug~     treatment with placebo. The results will be published.~   "
66381|NCT02188459|"~     Smoking during pregnancy adversely affects the health of the mother and her developing baby.~     Maternal smoking approximately doubles the risk of miscarriage, placental complications,~     preterm delivery, low birth weight and fetal and newborn death. The most common adverse~     effect of smoking during pregnancy is low birth weight, which sharply increases the risk of~     the newborn becoming ill or dying. In the US, maternal smoking is responsible for 30% of low~     birth weight babies, 10% of premature deliveries, and 5% of infant deaths. Fortunately,~     smoking cessation by pregnancy week 16, or as late as the third trimester, results in a~     near-normal weight infant at birth. Even reductions in smoking increase birth weight.~      Despite the known risks, the majority of women who are smoking at the time of their first~     prenatal visit continue to smoke. Bupropion is approved by the US Food and Drug~     Administration (FDA) for smoking cessation in people who are not pregnant, but there are no~     carefully controlled studies on the use of Bupropion to help pregnant women quit smoking.~     Bupropion is also FDA approved to treat depression, and some pregnant women have taken it~     for that purpose, even though it has not been formally tested. The investigators propose to~     conduct a randomized, parallel-group, double-blinded, placebo-controlled, 10 week trial of~     Bupropion in 360 pregnant women who smoke daily and wish to quit smoking.~      The study has three primary hypotheses. First, the investigators hypothesize that Bupropion~     treated subjects will decrease the frequency of smoking more than placebo-treated subjects.~     Second the investigators hypothesize that Bupropion treated subjects will have greater~     positive pregnancy and child health outcomes than placebo-treated subjects. Third the~     investigators hypothesize that Bupropion treated subjects will have decreased frequency of~     depressive symptoms and cigarette craving than placebo-treated subjects. These finding will~     provide information on the safety and efficacy of bupropion treat for smoking cessation in~     pregnant women.~   "
66382|NCT02188446|"~     Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial~     cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol~     consumption above two drinks per day is associated with an increased risk of postoperative~     morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is~     recommended to reduce this risk, but for cancer patients the preoperative period is often~     very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect~     of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using~     the Gold Standard Programme (GSP) on the frequency and severity of postoperative~     complications after bladder cancer surgery.~   "
66383|NCT02188433|"~     Although smoking prevalence is decreasing in Hong Kong, there are still 645,000 daily~     smokers 10.7% ( Thematic Household Survey 2012) and half will be killed by smoking (Lam~     ,2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001).~     Smoking also accounts for a large amount of medical cost, long-term care and productivity~     loss of US$688 million (0.6% Hong Kong GDP) (McGhee et al., 2006) (Census & Statistics~     Department (Hong Kong Special Administrative Region government), 2001). Smoking is a highly~     addictive behavior and it is difficult for smokers with strong nicotine dependence to quit~     without assistance. On the other hand, reaching and helping the many smokers who have no~     intention to quit is a challenge, because they are unlikely to seek professional help from~     smoking cessation services. The Quit and Win programme provides an opportunity to reach and~     encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit~     and Win model posits that smokers participating in the contest will have higher motivation~     to quit with incentives and better social support (Cahill & Petera, 2011). Studies have~     found that such quitting contests or incentive programs appeared to reach a large number of~     smokers and demonstrated a significantly higher quit rate for the quit and win group than~     for the control group (Cahill & Rafael, 2008).~      The Quit to Win Contest in 2014 and the study's interventions using cut down to quit~     approach are theoretically based on the Health Action Process Approach ( HAPA) for the~     intervention group (Schwarzer, 2008). The HAPA suggests that one's intention of behavior~     change can be fostered by knowing that the new behavior has positive outcomes as opposed to~     the negative outcomes that accompany the current behavior; and planning (action planning and~     coping planning) which serves as an operative mediator between intentions and behavior.~     Using gradual cut down approach on smoking cessation will probably increase smoker's~     self-efficacy on smoking cessation as the process could be achieved at the smoker's own~     perceived pace without placing too much pressure on themselves but with greater control of~     self in the cessation process. This was supported by the evidence that smoking reduction~     approach led to a greater self-efficacy to resist smoking and increased subsequent quitting~     (Broms, Korhonen, & Kaprio, 2008). Most importantly, reducing cigarette consumption will~     lower the nicotine dependence which is associated with later abstinence (Hughes et al.,~     2004). On the other hand, quitting immediately will have a less sense of control and may be~     subjected to relapse thus lower the self-efficacy on quitting.~      Therefore, the present study will examine (1) effectiveness of the cut down to quit (CDTQ)~     and quit immediately (QI) approaches; (2) explore the use of Community-Based Participatory~     Research (CBPR) model to build capacity and to engage community partners in taking on this~     important public health issue for sustainability in the community. In addition, process~     evaluation will be conducted to assess the effectiveness of the recruitment activity and how~     it is linked with the overall program outcomes.~   "
66384|NCT02188420|"~     After a stroke, there is an exaggerated inhibitory influence from the non-stroke hemisphere~     to the stroke hemisphere. Brain stimulation using repetitive transcranial magnetic~     stimulation (rTMS) to the non-stroke hemisphere can decrease this inhibition. Paired~     Associative Stimulation (PAS) may be a more effective way to produce this same inhibition,~     as shown in healthy subjects. However, it is not known whether this will translate to people~     with stroke. PAS consists of a peripheral nerve stimulus paired a short time later with a~     cortical stimulus to change the excitability within the brain. Thus the investigators will~     apply PAS to people with stroke, but the investigators need to first determine the most~     effective interpulse interval (IPI) between the peripheral and cortical stimuli. Our~     research question is which of three different IPIs is most effective in changing the~     excitability of the brain.~      The purpose of this study is to determine the optimal IPI between a peripheral nerve pulse~     and a cortical stimulus that will be most effective in changing excitability of the brain in~     people with chronic stroke. The investigators hypothesize that the cortical excitability of~     the nonstroke hemisphere will be most inhibited with the latency-5ms condition.~   "
66393|NCT02188303|"~     LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of~     the study will assess the safety and tolerability of single doses of LY2944876 in Japanese~     participants. Participation is expected to last up to about 7 weeks, not including~     screening.~      Part B of the study will investigate the safety and tolerability of multiple doses of~     LY2944876 in non Japanese participants. Participation is expected to last up to about 8~     weeks, not including screening.~      All doses will be administered as injections into the fatty layer just beneath the skin.~      Screening is required within 28 days prior to the start of the study. All participants will~     attend a post study safety assessment approximately 6 weeks after their final dose.~   "
66385|NCT02188407|"~     The aim of the study was to prospectively investigate the influence of one-lung ventilation~     (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the~     volatile anaesthetic sevoflurane.~      Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective,~     randomised study. The patients were randomly allocated into two groups to receive either~     propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.~      Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C-~     reactive protein)CRP) were measured intra- and postoperatively.~      Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was~     taken and assessed.~      The clinical outcome determinated by postoperative adverse events was assessed as the~     secondary endpoint.~   "
66386|NCT02188394|"~     Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of~     headaches, yet its efficacy in migraine has hardly been assessed with controlled studies.~     The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic~     blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)~     in different areas. We hypothesize that those patients receiving real GON anesthetic~     blockade will receive greater improvements in pain nociception. We will conduct a~     double-blind, randomized, parallel and placebo-controlled clinical trial where one group~     will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will~     be treated with placebo.~   "
66387|NCT02188381|"~     Hypertension is the single most prevalent risk factor for heart diseases, heart failure,~     kidney failure and stroke. About 1 in 3 adults in the United States have hypertension.~     Approximately 28-30% of hypertensive patients suffer from resistant hypertension (RH).~     Inflammation has been implicated in the pathogenesis of the hypertension. Additional data~     suggests the involvement of gut microbiota in host normal cardiovascular functions and~     pathophysiology. Accumulating evidence demonstrates that antibiotic treatment benefits~     patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular~     events. Even though these studies did not address effects of antibiotic treatment on the gut~     microbiota, it is possible that gut microbiota could affect neurologic inflammation.~     Finally, intestinal microbiota has recently been proposed to modulate blood pressure (BP)~     through production of short-chain fatty acids. In order to investigate this, the~     investigators hypothesize that gut microbiota is involved in the neuroinflammation-mediated~     initiation and establishment of RH, and targeting gut microbiota by minocycline would~     produce beneficial outcomes in RH.~   "
66388|NCT02188368|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness~     (good and bad effects) of pomalidomide given as part of a combination therapy that include~     more than just steroids to treat subjects with relapsed (subjects whose disease came back)~     or refractory (subjects whose disease did not respond to past treatment) multiple myeloma~     (MM).~      Pomalidomide (alone or in combination with dexamethasone) has been approved by the United~     States Food and Drug Administration (FDA) for the treatment of MM patients who have received~     at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated~     disease progression on or within 60 days of completion of their last therapy. However, the~     use of pomalidomide in combination with other drugs used to treat MM, such as~     chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not~     approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like~     lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere~     with the development of small blood vessels that help support tumor growth. Therefore, in~     theory, it may reduce or prevent the growth of cancer cells. The testing done with~     pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM~     both on its own and in combination with dexamethasone. Using another drug class, namely~     proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor~     with another in an established anti-myeloma treatment regimen can frequently overcome~     resistance regardless of the other agents that are part of the anti-myeloma regimen.~     Importantly, the toxicity profile of the new combinations closely resembled that of the~     proteasome inhibitor administered as a single agent. Based on this experience, we~     hypothesize that the replacement of lenalidomide with pomalidomide will yield similar~     results in a similar relapsed/refractory MM patient population.~   "
66389|NCT02188355|"~     The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in~     unselected patients representing everyday clinical practice. Also the study will assess the~     impact of non-compliance with dual antiplatelet therapy, one month after stent~     implementation (frequently observed in every day clinical practice), on stent thrombosis.~   "
66390|NCT02188342|"~     The primary aim of this study is to determine whether an improvement in aerobic fitness, as~     judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a~     group of older, colorectal cancer patients.~   "
66391|NCT02188329|"~     The primary purpose of the National Survey of Early Care and Education (NSECE) was to~     provide a comprehensive snapshot of both the availability and utilization of early care and~     education in the United States. The main objectives of the study included:~        -  Providing the first national portrait of the availability of early care and education~          for the full spectrum of care providers, including householders and providers from all~          50 states and the District of Columbia.~        -  Identifying early care and education and school-age care (ECE/SA) needs and preferences~          among households in the United States with children under age 13 as they pertain to~          supporting both the employment of parents and the development of children.~        -  Capturing data on all forms of non-parental care for all children in a household.~        -  Providing the perspectives of both families and providers on the services offered in a~          system where children are often in multiple arrangements and providers receive funding~          from multiple sources.~        -  Linking the data set collected with policy-relevant data.~        -  Increasing the understanding of the care received by low-income children and how that~          varies across communities.~      The NSECE is a set of four integrated, nationally representative surveys conducted in 2012.~     These were surveys of 1) households with children under 13, 2) home-based providers 3)~     center-based providers, and 4) the center-based provider workforce. Together they~     characterize the supply of and demand for early care and education in America and permit~     better understanding of how well families' needs and preferences coordinate with providers'~     offerings and constraints.~   "
66392|NCT02188316|"~     -  Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still~          widely used methods for endoscopic resection of diminutive colorectal polyps~          (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of~          DCPs because of their larger size.~        -  This was a prospective study of consecutive patients undergoing colonoscopy and found~          to have at least one diminutive polyp. One experienced endoscopist removed DCPs using~          either jumbo or hot biopsy forceps.~        -  Aim was to evaluate the histological quality and adequacy of the DCPs resected using~          jumbo forceps in comparison with HBF.~   "
66398|NCT02188238|"~     The aim of this study is to help us understand how saliva forms a thin film inside the~     surfaces of the mouth which is known as the salivary pellicle, and how this film helps to~     protect our teeth from decay. We know that the thickness and physical properties (viscosity~     and mechanical strength) of the salivary pellicle influences:-~        -  How we chew and sense the structure of food in our mouth.~        -  How we digest the food and extract nutrients from it.~        -  Protection against tooth decay and infection.~      However, studies have only recently established the different proteins within the pellicle.~     The effects of oral care products (e.g. toothpaste, mouthwash etc.) and ingredients they~     contain on pellicle formation and removal remain poorly understood. Therefore we need to~     understand how the formation of the salivary pellicle is controlled by ingredients it comes~     into contact with such as those from food and oral hygiene products (e.g. toothpaste and~     mouthwash).~      In this study, we are asking volunteers to provide samples of saliva. We will take the~     saliva samples back to our labs and measure how they form films under different conditions~     and determine the influence of ingredients from oral hygiene on the film forming properties.~     We will also measure the protein content of the saliva sample to see how this affects~     pellicle formation. Eventually, this information together with knowledge from other studies,~     should lead to the development of more effective oral hygiene products.~   "
66399|NCT02188225|"~     The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on~     improvement quality of life among menopausal women.~   "
66400|NCT02188212|"~     Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult~     patients will be treated. Female or male, with an age range from 18 (or age of consent) to~     70 years, provided they fulfill the inclusion criteria and need two single tooth~     restorations on contralateral teeth in the same arch. Each patient will receive in minimum~     one NobelProceraTM Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max~     CAD in lithium disilicate on the 1st or 2nd molar randomly allocated to the same tooth~     position contra-laterally in the maxilla or mandible. The patients will be followed for 5~     years after receiving their final prosthetic restorations. Possible dropouts and~     withdrawals, as well as possible adverse events, will be carefully monitored during the~     entire investigation period.~   "
66401|NCT02188199|"~     This study will assess the efficacy of products, implants, and procedures for knee and hip~     replacement.~   "
66402|NCT02188186|"~     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option~     in the treatment of drug-naïve Korean type 2 diabetic patients.~   "
66403|NCT02188173|"~     This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema~     (DME).~   "
66404|NCT02188160|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
66405|NCT02188147|"~     The purpose of this study is to conduct an observational investigation of a novel care path~     used to manage emergency department (ED) presenting syncope patients on an outpatient basis.~   "
66406|NCT02188134|"~     Per-capita consumption of medication is higher in older adults than any other sector of the~     population. In fact, it has been estimated that although older adults comprise 13% of the~     population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs)~     consumed in the US (National Council on Patient Information and Education, 2010). Given~     current trends in aging, the savings, freedom and flexibility that self-medicating provides,~     as well as the trends to switch prescription products to an OTC status, it is likely that~     older adults will increasingly turn to OTCs as part of their medical regimens for years to~     come (Hanlon, J et al, 2001).~      In addition to the advantages that self-medicating offers, there are risks. These risks are~     more pronounced in older consumers, who are likely experiencing physiological changes (e.g.~     pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a~     propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has~     also been suggested that low health literacy rates in older consumers detrimentally impact~     health and health outcomes in this population (Kutner et al., 2005 and Federman et al.,~     2009).~      Despite the risks associated with improper OTC use, the critical importance of OTC labeling~     information (there is no learned intermediary), and the fact that older consumers are~     significantly more likely to experience an adverse drug reaction than younger adults,~     surprisingly little information exists about the decision making process older adults employ~     when selecting and using an OTC product.~      We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The~     study has the following objectives:~        1. To begin to garner insights regarding the proportion of subjects who closely examine~          (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or~          not) a drug is appropriate for them (based on their health history and current~          medications).~        2. To quantify and compare the attentive behaviors to specific information (Specifically:~          name, active ingredient, symptom relief).~        3. To quantify and compare the attentive behaviors to different formats of information~          (prominently featured information vs less prominently featured information).~        4. To begin to benchmark whether or not older consumers make appropriate choices based on~          their current conditions and medication history.~   "
66407|NCT02188121|"~     Patients with severe mental illness (SMI) die younger than persons in the general~     population. Much of the excess mortality for SMI patients is attributable to cardiovascular~     disease, and is exacerbated by treatment with second-generation antipsychotics (2GAs).~     Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few~     SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor~     patient adherence are central problems to reducing cardiovascular risks for patients with~     SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized~     controlled trial comparing an initial treatment strategy of free, fixed-doses of two~     generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within~     mental health clinics versus usual treatment. The study will include adult patients (18+~     years old) with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive~     disorder, or psychosis NOS who have received 2GAs treatment within the past six months from~     within four mental health clinics in the Boston area. We have three aims: 1) to compare the~     proportions of subjects in each arm who are receiving cardiovascular drug treatment and are~     adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g.,~     Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels~     using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting~     for variation in adherence over time, using causal inference techniques to estimate the~     per-protocol effect of the intervention. Our three aims examine whether this low cost,~     streamlined treatment strategy increases the numbers of subjects receiving cardiovascular~     prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12~     months, and collect interview and biometric data at baseline and over the following 12~     months. Subjects will have the option to continue for another 12 months, during which we~     will continue to collect interview and biometric data, but will not prescribe cardiovascular~     medications. This population-based initial treatment strategy could be an effective and~     efficient approach for overcoming traditional barriers to cardiovascular disease prevention~     within the SMI population. Findings from this study will inform efforts to improve care and~     outcomes, and to enhance survival for patients with severe mental illness.~   "
66501|NCT02186873|"~     The purpose of this study is to evaluate the efficacy of intravenously (administration of a~     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants~     with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that~     involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral~     joints).~   "
66408|NCT02188108|"~     The overall purpose of this study is to evaluate criterion-related validity of a~     newly-developed disease-specific instrument to assess the health-related quality of life~     (HRQOL) of patients who have had kidney stones. Specific aims of this study are:~        1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin~          Stone-QOL by answering the question, Is the Wisconsin Stone-QOL useful for assessing~          the HRQOL of patients who form kidney stones from a broad region of North America?~        2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients~          related to stone interventions and other disease-specific outcomes by answering the~          question, Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes~          within individuals?~   "
66409|NCT02188095|"~     Clinical and radiological 3 year results of Excia T® Hip Stem~   "
66410|NCT02188082|"~     Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of~     sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of~     IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to~     severe chronic systolic heart failure.~   "
66411|NCT02188069|"~     SCAD (Spontaneous coronary artery dissection - tear in the arterial wall that is not related~     to trauma) is an under-diagnosed and poorly understood condition that mostly affects young~     women without common cardiovascular risk factors, and can result in heart attack and death.~     This observational study is designed to capture the disease's natural history and~     predisposing arteriopathies (medical conditions resulting in changes in the arteries),~     treatment strategies, long-term cardiovascular outcomes. It will also improve the diagnosis~     of SCAD on coronary angiography by participating clinicians, and provide guidance on~     investigating predisposing conditions.~   "
66412|NCT02188056|"~     Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year~     after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence,~     estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For~     a number of these patients, risk factors have been identified (congenital or acquired~     thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of~     cases, the etiology remains unknown, justifying the need for well-conducted studies to~     determine other potential risk factors. In addition, the expansion of treatment options with~     the arrival on the market of new direct oral anticoagulants, allows comparative studies on~     the effectiveness and frequency of adverse events for each treatment.~   "
66413|NCT02188043|"~     The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients~     at a general hospital to start specialized alcohol treatment in order to assess i) efficacy,~     ii) cost-effectiveness and iii) overall societal cost impacts.~      The effect of the Relay Model will be investigated in a single-blind pragmatic randomised~     controlled trial in which the control group consists of patients referred to treatment by~     usual procedures.~   "
66414|NCT02188030|"~     This study is double-blinded RCT, whose aim is to assess if an individual exercise program~     is more effective to reduce complaints in neck, shoulders and arms that an group exercise~     program, in industrial workers.~      The participants will be randomly allocated to receive 12 treatment sessions of individual~     exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes~     and will be held twice a week for 12 weeks. Participants will also be encouraged to continue~     the use of medicines and other health care.~   "
66415|NCT02188017|"~     An randomized trial of two maintenance doses of Acthar Gel for patients with chronic~     pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.~   "
66416|NCT02188004|"~     primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases~     in subjects.~      Secondary purpose:Analyze risk factors of HPV infection and related diseases.~   "
66417|NCT02187991|"~     The goal of this clinical research study is to learn if the study drug, alisertib, in~     combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with~     hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple~     negative) locally recurrent or metastatic breast cancer. The safety of alisertib in~     combination with paclitaxel will also be studied. The physical state of the patient,~     symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study~     will help the research team decide if alisertib plus paclitaxel is safe and effective in~     patients with this type of breast cancer.~      Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the~     activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and~     survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer,~     including breast cancer, and preclinical studies suggest that blocking the activity of this~     protein can lead to the death of cancer cells.~      Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer,~     including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that~     in cancer therapy, combinations of drugs are often more effective as a treatment than either~     of the same drugs used alone.~   "
66418|NCT02187978|"~     The purpose of this study is to compare the effect of early total oral feeding versus~     conventional oral feeding in stable VLBW infants. In current clinical practice, the~     introduction of oral feeds for VLBW infants is often preceded by a period of fasting or~     minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be~     associated with potential disadvantages and increased infectious and metabolic complications~     related to prolonged fasting and use of parenteral nutrition. The studies conducted till~     date have shown better outcomes and improved postnatal growth with early initiation and fast~     advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total~     oral feeds on day 1 of life. No such study has been conducted on early total oral feeding~     but observational work in our unit has shown it to be safe without any increased incidence~     of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW~     infants all over the world, the investigators decided to assess the effect of early total~     enteral feeding in stable VLBW infants.~   "
66419|NCT02187965|"~     Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different~     testing days for 2.5 hours each day. On one day the subjects participated in blood pressure~     and body weight measurements as well as a muscle biopsy from the thigh. On the second day~     the subjects underwent an MRI and MRS scan of the thigh and calf.~   "
66420|NCT02187952|"~     The primary objective of the proposed study is to determine whether behavioral feeding~     intervention impacts mother-child attachment in infants and toddlers with feeding problems.~     The investigators propose the following hypotheses:~        -  Behavioral feeding intervention will not significantly impact parent-child attachment.~        -  Behavioral feeding intervention will not significantly impact parent-child unstructured~          play interactions.~        -  Severity of feeding problems will decrease after behavioral feeding intervention is~          implemented.~        -  Behavioral feeding intervention will have either no significant effect or a significant~          positive effect on general child behavior.~   "
66421|NCT02187939|"~     Get in the GROOVE! will address health disparities impacting underserved youth. Given the~     alarming rate of overweight and obesity among high school minority youth, the project will~     focus on middle school with the primary aim of reaching middle school girls before unhealthy~     habits become firmly ingrained.~      The primary aim of the research project is to investigate the impact of two types of summer~     science enrichment programs (that focus on health and wellness) on middle school girls'~     self-efficacy, health knowledge, health behaviors, and interest in science. One program will~     present the curriculum by conventional means (GROOVE condition) while the second program~     will include the addition of a closed 3-D virtual world environment to reinforce concepts~     (GROOVE+ condition).~      The following hypotheses will be tested in the randomized controlled trial:~        1. Upon completion of the summer program, the enhanced summer program GROOVE+ relative to~          the conventional summer program will result in a) increased self-efficacy for adopting~          healthy behavior change; b) increased health knowledge; c) enhanced science~          self-concept; and e) more positive behavior change (e.g., improved nutrition, increased~          physical activity).~        2. At follow-up, the enhanced summer program relative to the conventional summer program~          will result in further and/or sustained improvements in positive behavior health~          behaviors and attitudes.~   "
66422|NCT02187926|"~     The purpose of this study was to examine the characteristics of patients selected for~     treatment with roflumilast and the effectiveness and safety of roflumilast in patients with~     severe or very severe COPD treated in Hospital and outpatient specialist ward settings in~     Greece.~   "
66423|NCT02187913|"~     -  About two-thirds of adults in the United States are overweight or obese which can cause~          adverse health consequences for those individuals. Post-prandial hyperglycemia is one~          of these possible consequences and is associated with a higher risk for Type 2~          Diabetes. Controlling hyperglycemia is important in the prevention of the onset of~          diabetes and obesity. Resistant starch is a dietary carbohydrate which is not~          completely digested in the gut and produces energy for the body to use. The~          investigators are interested in assessing the effects of resistant starch on~          postprandial blood glucose and insulin concentrations.~        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and~          insulin concentrations.~        -  Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the~          post-prandial rise in blood glucose and insulin concentrations compared to a baked~          snack bar with maltodextrin (an easily digested carbohydrate).~   "
66424|NCT02187900|"~     The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii~     HOOK. f. is effective and safe in the treatment of IgA nephropathy.~   "
66425|NCT02187887|"~     The primary objective of the research study is to test the feasibility of a brief~     Internet-based intervention to reduce heavy alcohol use among young adult veterans of wars~     in Iraq and Afghanistan. Veterans are recruited through the social media website Facebook in~     two phases. In the first phase, investigators collect data from 800 veteran participants to~     document and analyze drinking norms in this population. In the second phase, investigators~     use the norms collected in Phase 1 and information from the analyses to develop and pilot~     test an online intervention with young adult veteran participants. Six hundred participants~     are recruited through Facebook and randomly assigned to intervention (N = 300) or control (N~     = 300) conditions. It is hypothesized that those in the intervention condition will drink~     less at a one-month follow-up period than those in the control condition. Investigators also~     collect feedback from participants on the usability of the online intervention.~   "
66426|NCT02187874|"~     Early cord clamping after delivery has been common practice for many decades as part of the~     active management of the third stage of labour. However in recent years, several studies~     have shown that delayed cord clamping may offer important benefits to the newborn. The data~     gathered indicate that delayed cord clamping may be particularly useful in premature babies,~     between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the~     incidence of intraventricular haemorrhage.~      However it is argued that the described potential benefits of delayed cord clamping could be~     negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by~     potential interference with the postpartum haemorrhage management, initial care and~     reanimation of the premature newborn, and the possibility of cord blood donation. These~     factors, together with as the lack of homogeneity among existing studies regarding the~     delayed cord clamping technique create the need, in our opinion, for further research, to~     establish the proper place of this measure.~      Our hypothesis is that delayed cord clamping in the premature newborn significatively~     reduces the need for blood transfusions and intraventricular haemorrhage, compared with~     usual early cord clamping.~      Secondary outcomes:~        -  To define the impact of delayed cord clamping on neonatal assessment parameters after~          delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.~        -  Neonatal mortality and morbidity~        -  Effect of the procedure on the incidence and severity of maternal postpartum~          haemorrhage~        -  To study the correlation between Iron metabolism and reticulocitary haemoglobin levels~          in cord and infant blood.~   "
66514|NCT02186704|"~     The primary aim of the Sensing Atrial High Rate Episodes with DX System in Implantable~     Cardioverter Defibrillators Trial (SENSE Trial) is to assess the efficacy of a implantable~     cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting~     atrial high rate episodes.~      The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles~     will have a diagnostic yield comparable to that of a standard dual chamber ICD system and~     superior to that of a standard single chamber ICD system.~   "
68549|NCT02160067|"~     The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and~     relative bioavailability assessment of 2nd generation BTDS patches compared to 1st~     generation BTDS patches.~   "
66427|NCT02187861|"~     This open-label, international, multicenter study will investigate the safety and efficacy~     of GDC-0199 in combination with bendamustine plus rituximab (GDC-0199 + BR) compared with BR~     alone in participants with relapsed and refractory fNHL, comparing two~     chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an~     exploratory analysis of the safety and efficacy of GDC-0199 in combination with rituximab~     (GDC-0199 + Rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free~     Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be~     decided at the discretion of the investigator, unless one of the cohorts is not open to~     enrollment; in which case, participants may be enrolled only to the open cohort. The first 6~     participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will~     comprise the Safety Run-In group for Treatment Arm B, dosing GDC-0199 at 600 milligrams (mg)~     in combination with BR. Once a dose has been chosen from the Safety Run-In Period,~     randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C)~     will begin. The anticipated time on study treatment is approximately 24-52 weeks, depending~     on treatment arm.~   "
66428|NCT02187848|"~     Primary Objectives:~      To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once~     every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid~     tumors (Escalation Phase).~      To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST~     1.1) (Expansion Phase) of SAR408701 administered once every 2 weeks without a loading dose~     at Cycle 1.~      Secondary Objectives:~      To characterize the overall safety profile of SAR408701. To characterize the pharmacokinetic~     (PK) profile of SAR408701 and of its potential circulating derivatives.~      To identify the recommended phase 2 dose (RP2D) of SAR408701. To assess the potential~     immunogenicity of SAR408701.~   "
66429|NCT02187835|"~     Aim was to detect EEG complexity in a specific group of patients to contribute to the~     discussion whether schizophrenia is associated with increased or decreased complexity. We~     included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized~     that chronic residual schizophrenia is characterized by decreased complexity in EEG.~   "
66430|NCT02187822|"~     The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and~     tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better~     controlling the growth of brain lesions in people with brain metastases from their cancer.~   "
66431|NCT02187809|"~     To investigate the long-term safety and tolerability of clobazam when administered for 1~     year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.~   "
66432|NCT02187796|"~     1. To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence~          of~             -  NC (normal cognition )~             -  ANI (asymptomatic neurocognitive impairment )~             -  MCD (mild cognitive disorder )~             -  HAD (HIV-associated dementia )~        2. To determine whether the following variables affect the three categories of HAND~             -  Time since first diagnosis of HIV infection~             -  Anti-viral medications used~             -  Age~             -  Gender~   "
66433|NCT02187783|"~     The purpose of this signal seeking study is to determine whether treatment with LEE011~     demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
66434|NCT02187770|"~     The purpose of this study is to determine if IMED-4 recordings have sufficient precision to~     detect a clinically significant change in lung fluid status in acute heart failure syndrome~     with pulmonary congestion.~   "
66435|NCT02187757|"~     Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood~     lipid levels~   "
66436|NCT02187744|"~     The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014~     (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus~     Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin~     (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant~     setting. The hypothesis to be tested in this study is the percentage of patients with steady~     state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to~     EU-approved trastuzumab, using a margin of -12.5%.~   "
66437|NCT02187731|"~     The FULIMA study is a two-center study at Odense University Hospital and Vejle Hospital,~     Denmark. The primary objective is to identify the optimal imaging technique for studies in~     multiple myeloma with focus on PET/CT and MRI.~      By combining early (1 hour) and late (3 hours) 18F-2-fluoro-2-deoxy-D-~     fluorodeoxyglucose(18F-FDG)-PET/CT scans the investigators expect to see increased uptake of~     radioactive tracer and thus an improved ability to identify malignant tissue. A second~     tracer 18F-natrium-fluoride is used to explore early signs of bone remodeling. By using new~     software (ROVER) for interpreting PET data the investigators expect to obtain a quantitative~     measurement of total disease burden with less risk of misinterpretation of data.~      Diffusion weighted MRI (DWI) is a new MRI technique which, like PET/CT, makes it possible~     quantitatively to calculate the overall disease activity and to give an early evaluation of~     response to chemotherapy. The study examines DWI for development and standardization.~      To validate imaging findings and to explore the pathogenetic heterogeneity of multiple~     myeloma, the investigators perform CT guided biopsies from PET/ DWI positive sites.~     Pathoanatomical and immunohistochemical findings and gene expression data from positive~     sites are compared to random bone marrow. The question is whether disease heterogeneity may~     explain the lack of FDG uptake in bone marrow in some patients? To the extent that the~     FULIMA study produces useful data, the defined and standardized imaging techniques will form~     the basis of a larger prospective study at national level in Denmark.~   "
66438|NCT02187718|"~     Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator.~     At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC)~     of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When~     US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery.~     Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the~     abovementioned diagnostic entities reveals lymph node metastases. However, the extensive~     role of ALND in BC patients with lymph node metastases may change or diminish in upcoming~     years due to emerging evidence that completion ALND (cALND) does not affect disease-free~     survival and overall survival in early BC patients with (sentinel) node-positive disease.~     Whether ALND is needed in these patients, should be based on (axillary) tumour load. Because~     of the fact that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the~     role of SNP might become even more important in upcoming years.~      Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a~     patient tailored treatment plan can be made and discussed with the patient before breast~     surgery. In this context, it would be very logical to perform a SNP under local anaesthesia~     (LA), prior to breast surgery. This might not only lead to significantly less two-step~     surgical procedures under general anaesthesia (GA), but might also lead to a reduction of~     depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because~     BC patients are in particular risk for psychological distress in the first three months~     after diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as~     possible (by performing a SNP under LA), might reduce this psychological distress. To~     investigate which BC patients would benefit most from SNP under LA, the investigators~     recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node~     metastases and prevalence of false negative results of US+FNAC were directly associated with~     age <60 years and with primary breast tumour size >20 mm. Hence, these BC patients might~     benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC~     patients (i.e. <60 years with a breast carcinoma >20 mm) will be analysed.~      Objectives: Reduction of the mean number of operations under general anaesthesia per~     patient. Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.~      Study design: Prospective single centre randomised controlled clinical trial. Study~     population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of~     >20 mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.~      Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control:~     Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study~     parameters: Primary outcome parameters are the number of operations under GA per patient and~     the number of operations under LA per patient. Secondary outcome parameters are QoL,~     experienced depressive symptoms and anxiety.~      Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to~     the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power~     0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical~     procedures under general anaesthesia with 30%. Data will be analysed using descriptive~     statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis~     test, students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test,~     Pearson's and Spearman's rank correlation coefficients and finally logistic and linear~     regression analysis.~   "
66439|NCT02187705|"~     The aim of this observational study was to supplement the data on efficacy, safety, and~     tolerability of telmisartan under daily conditions in hospitals~   "
66440|NCT02187692|"~     The aim of the study is to compare the effectiveness of the meta-cognitive training (MCT)~     for schizophrenia against treatment as usual (TAU) among patients who attends community~     support groups. 4 weeks of MCT will be administered for patients two times per week. MCT~     consists of well structured cognitive behavioral therapy interventions. MCT will be~     administered according authors recommendations. All participants will be assessed at~     baseline (T0) and up to one week after the MCT intervention (T1, 4-5 week of the study).~   "
66441|NCT02187679|"~     Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal~     cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy~     trial to understand the right dosage of Abobotulinum toxin A which can be affective. The~     study will involve an injection of 2.5 units of Dysport on each side of the affected vocal~     cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also~     complete a self assessment survey on how vocal tics affect their daily lives. Afterward, a~     further evaluation of the tics will be conducted by the investigator using the Yale Global~     Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear,~     Nose and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a~     provoked cough by the patient. This will allow the lidocaine to be sprayed throughout the~     airway preventing coughing and swallowing during the procedure. An Electromyography (EMG)~     guidance a needle containing Dysport will be injected into the thyroarytenoid muscles will~     potentially reduce the vocal dyskinetic features in patients with TS. This needle will be~     connected to a syringe and once determined active, it will be placed appropriately when the~     EMG emits a characteristic sound. If this does not occur with the patient then the injection~     will be administered under direct vision via direct laryngoscopy using an orotracheal~     injector system.~      This procedure is conducted in an outpatient clinic because no hospitalization is required.~     The patient is not allowed to consume food or drink for about 45-60 minutes after the~     injection. The throat will be numb and may cause coughing and some blood tinged sputum: The~     expectancy of this outcome is reason to not consider is a serious event. Asprin and~     ibuprofen is not allowed a week prior to and until the injection at least 3-4 days after to~     prevent excessive bleeding. The patient is also instructed to ensure that they chew their~     food thoroughly and drink sufficient water for the initial days after the study~     intervention. Mild dysphasia may be noted initially which should resolve within a few hours.~     On Visit 1, the patient will complete all required study documents and forms. Then the ENT~     physician will proceed with the injection Dysport on the same day. If unforeseen~     circumstances render the subject unable to be injected on the same day, the intervention~     must take place within three days and this will be considered V1, follow up events should be~     scheduled accordingly.~   "
66442|NCT02187666|"~     The primary objective of the Spine Registry is to enhance the understanding of spinal~     disease and treatment of spinal disease with the goal of guiding treatment options.~   "
66443|NCT02187653|"~     The primary objective of this study is to evaluate the rate of new or worsening neurologic~     deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using~     neurological testing (motor and sensory) in the optimal management of the surgical patient.~   "
66444|NCT02187640|"~     This study is to evaluate the effects of self-administered acupressure therapy for~     psychiatric in-patients with constipation~      Two main research questions include:~        1. What are the effects of the standardized self-administered acupressure program on~          reducing those adult psychiatric patients' symptoms of constipation?~        2. What are the psychiatric patients' (participants') perceived benefits and limitations~          of self-administered acupressure on management of their constipation?~      In this study, the participants who met the study criteria and completed the baseline~     measurement would be randomly assigned into either the self-administered acupressure~     program, or a sham control group who receive a placebo, non-acupoint pressure. The null~     hypotheses of this study are:~        1. There is no significant difference between the acupressure and sham group immediately~          and/or two weeks after the completion of intervention on patients' symptom severity of~          constipation; and~        2. There is no significant difference between the acupressure and sham group on patients'~          perceived quality of life at immediately and two weeks after treatment completion.~   "
66445|NCT02187627|"~     This study is designed to obtain basic information on three PET imaging tracers developed to~     detect tau pathology in the brain. In this study, healthy control participants and~     participants with AD will be studied. Information collected will include brain and plasma~     kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest~     variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part~     2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one~     tracer will be prioritized over the other two tracers. The tracer selected will be further~     investigated in Part 2A and Part 2B.~   "
66446|NCT02187614|"~     Abdominal pain is one of the most common presentations to an emergency department (ED).~     Among patients presenting with abdominal pain, a common diagnosis in the Middle East is~     renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around~     in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe~     analgesia and to be pain free as early as possible. There are variations in physician~     preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:~        -  Opioids such as Morphine or Fentanyl~        -  Non steroidal drugs such as Diclofenac, Ketorolac or Brufen~        -  and Paracetamol intravenous injection.~      A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking.~     This study is design to obtain data on efficacy of these three drugs within 30 minutes in a~     non inferiority trail.~   "
66447|NCT02187588|"~     Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of~     Eschscholtzia Californica per os and placebo in patients undergoing dental surgery over an~     observation period of 6 hours. In a secondary analysis, kinetic of analgesic effect~     comparison between Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg~   "
66448|NCT02187575|"~     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules~     (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.~   "
66449|NCT02187562|"~     The objective of this study was to investigate the influence of meloxicam on low dose~     aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is~     given before aspirin.~   "
66450|NCT02187549|"~     The purpose of this study is to determine whether intra-articular hyaluronic acid provides~     symptomatic relief of osteoarthritis of the knee.~   "
66451|NCT02187536|"~     To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant~     administration of telmisartan~   "
66452|NCT02187523|"~     A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose~     combination in comparison to the single unit formulations~   "
66453|NCT02187510|"~     The purpose of this study is to determine whether the umbilical cord milking in preterm~     infants born by cesarian section less than 34 weeks is more effective than delayed cord~     clamping to obtain higher levels of hemoglobin.~   "
66454|NCT02187497|"~     The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives~     was evaluated. The results of the present study are to be used in the Japanese population~     pharmacokinetics analysis~   "
66455|NCT02187484|"~     The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were~     evaluated in hypertensive patients with nephropathy~   "
66456|NCT02187471|"~     DS 5565 will be better than placebo (sugar pill without active drug) in managing~     fibromyalgia pain and will be well tolerated.~   "
66457|NCT02187445|"~     Acute and chronic pulmonary complications with concomitant inflammatory response are a~     leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute~     chest syndrome (ACS), defined broadly as an increase in respiratory effort, fever and new~     radiodensity on chest x-ray, is a major cause of death in children and adults with SCD.~     There is a high rate of ACS in children between 1 and 4 years of age that is associated with~     an asthma diagnosis, and children with ACS events before 4 years of age have a 50% rate of~     being hospitalized for either ACS or pain within 1 year of admission. For children with SCD~     that develop ACS, the investigators propose that the use of budesonide inhalation suspension~     (BIS) will attenuate pulmonary inflammation after an ACS episode and will decrease future~     vaso-occlusive pain and ACS episodes. Through a single-arm prospective feasibility trial and~     in preparation for a limited-institution randomized trial, the investigators plan to test~     the following primary hypothesis for a phase III definitive trial: In children with SCD~     admitted to the hospital for an ACS episode between 1 and 4 years of age, low dose BIS for 6~     months will result in a 50% reduction in the recurrent incidence rate of ACS or pain~     requiring hospitalization. Through this trial, the investigators will determine the~     acceptability of and adherence to BIS in the study population. The investigators will track~     respiratory symptoms in cases versus controls over 6 months. Finally, the investigators will~     explore the impact of BIS on biological correlates (sVCAM-1).~   "
66458|NCT02187432|"~     EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant~     polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational~     cohort study has the potential to identify progression factors and biomarkers, and to assess~     disease stage specific mortality, morbidity and health care costs.~   "
66459|NCT02187419|"~     The purpose of this study is to determine feasibility and adherence to a hypnosis program to~     improve sleep. It is theorized (based on prior experience and pilot data) that one or more~     hypnosis program(s) will be feasible and will exhibit acceptable adherence. The programs~     will assess to determine optimal dose (3 vs 5 sessions) and method (audio-recorded vs~     therapist delivered).~   "
66460|NCT02187406|"~     Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the~     completion of a tennis warm-up.~   "
66461|NCT02187393|"~     The investigators are trying to understand the role of specific genes in the function of~     airway surface cells. The investigators know that there are some common genetic markers that~     are associated with various lung diseases. However, most people with these genetic markers~     never develop any evidence of lung disease, so it is not understand how or if these markers~     play a role in disease. Investigators are asking healthy people to provide three (3) tubes~     of blood as well as a sample of cells from their nose. Investigators will use the blood~     sample to provide genetic information (specifically, presence or absence of alleles known to~     be associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers~     that investigators are studying will be grown in the the lab to allow investigators to learn~     more about how the cells respond to various forms of environmental stress, such as exposure~     to cigarette smoke. The goal of this study is to understand how specific genes affect airway~     cell function.~   "
66462|NCT02187380|"~     The objective of the SIMCA study was to analyse the impact of structured medication~     counselling by community pharmacists on medication adherence, economic, clinical and~     humanistic outcomes of depressed primary care patients who started a new treatment with~     antidepressants.~      A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At~     the time of the start of the study, the Surplus Network included 97 pharmacies, in all five~     Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were~     informed about the SIMCA-study and instructed how to approach eligible patients.~      Randomisation was obtained at the pharmacy level by a computerized random-number generator,~     following a permuted block design (1:1). The Surplus Network contains a number of local~     pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy~     chains.~      Pharmacists in the intervention group were trained in communication skills related to~     depression treatment counselling in groups of no more than 10 participants over a single~     day. In total, 10 training days were scheduled between November and December, 2010.~      Patients were eligible for inclusion in the study if they started using at least one~     antidepressant drug, if they were at least 18 years old, if they were able to understand and~     complete Dutch questionnaires and if they could be reached by telephone for follow-up.~     Starting was defined as not having been prescribed antidepressants over the last six~     months, which was checked in the pharmacy records. If the patient gave verbal consent to the~     pharmacist, to be contacted by the research team, the patient was provided with written and~     oral information about the SIMCA project and a consent form. At the same time an automatic~     e-mail was generated from the pharmacy software to inform the research team about the~     patient's willingness to be contacted about the study. The patient was contacted by the~     research team, as soon as possible to give more information about the study, to ask for~     informed consent and to schedule a first telephone survey interview. If the patient wished~     to participate, he/she completed the consent form, and sent it back with the included~     postage-paid envelope addressed to the research team. Upon receipt of the consent form, the~     recruited patient's prescribing doctor was contacted and asked to complete and return a~     brief questionnaire to provide the diagnosis and its severity related to prescribing~     antidepressants.~      Telephone survey interviews based on validated scales were used to collect data at the start~     of treatment (as close as possible to the time of recruitment), after one month, three~     months and six months of treatment.~   "
66463|NCT02187367|"~     The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an~     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to~     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is~     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of~     proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in~     Cuba. The result from previous studies demonstrated positive correlation between extended~     survival and immune response against the vaccination in the late-stage NSCLC patients' age~     below 60 with improved quality of life. The purpose of this international Phase 3 trial is~     to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and~     effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF~     biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.~   "
66474|NCT02187224|"~     This is a randomized control trial with 36 participants diagnosed with post-traumatic stress~     disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive~     either progesterone (200 mg. bid) or placebo in identical looking capsules for three days.~      One goal of this research study is to test if progesterone is more effective than placebo in~     reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm~     among men and women with AD and PTSD. We hypothesize that progesterone in comparison to~     placebo will significantly reduce craving for alcohol in response to trauma cues alone and~     in combination with alcohol cues in individuals with AD and PTSD.~      A second goal is to examine if there are gender differences in progesterone effects on~     stress and alcohol cue-induced craving. We hypothesize that the effects of progesterone on~     stress and craving will be stronger in women than in men. Participants will be recruited~     primarily through advertisement, but also through the clinical facilities at the VA and from~     other collaborators.~   "
66464|NCT02187354|"~     Primary Objective:~      To estimate the incidence of treatment-emergent and treatment-related adverse events during~     treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in~     second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to~     other treatments~      Secondary Objective(s):~      To describe key efficacy outcomes, including incidence of complete response (CR) within 2~     cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of~     blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and~     100-day mortality after alloHSCT.~      Hypotheses:~      A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and~     treatment-related adverse events will be estimated.~      Study Endpoints:~        -  Incidence of treatment-emergent and treatment-related adverse events~        -  Incidence of CR within 2 cycles of blinatumomab~        -  MRD remission within 2 cycles of blinatumomab~        -  RFS~        -  OS~        -  Incidence of alloHSCT~        -  100-day mortality after alloHSCT~      Study Design:~      Multi-center, open-label, single-arm expanded access protocol~   "
66465|NCT02187341|"~     It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it~     has been shown that intense exercise stimulates an increase in plasma and salivary cortisol~     levels. The purpose of this study is to examine the combined effects of 5-HTP + intense~     exercise on plasma and salivary cortisol levels.~   "
66466|NCT02187328|"~     The purpose of this study is to determine whether grapefruit juice alters the metabolism of~     cortisol following intense exercise.~   "
66467|NCT02187315|"~     Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent~     combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with~     induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with~     intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of~     locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two~     groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative~     effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.~   "
66468|NCT02187302|"~     This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC)~     which has progressed through 2 to 3 prior lines of therapy, with the investigational drug~     CRLX101 in combination with bevacizumab compared to treatment with a standard of care~     therapy. The study will compare which treatment resulted in longer time before progression~     of the RCC. Patients will be treated and followed for progression of their disease on~     average for up to 6 months.~   "
66469|NCT02187289|"~     Lymphedema (significant arm swelling on the surgical side) is one of the most common~     complications following treatment for breast cancer. The impact of lymphedema is profound,~     resulting in negative self image, increased anxiety and poorer quality of life. In time,~     lymphedema can result in recurrent infections in the arm, functional impairment and pain.~     Approximately 21% of women who undergo breast cancer treatment develop lymphedema.~     Unfortunately this is a life-time condition which tends to worsen over time. Currently,~     treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by~     the wearing of compression sleeves during the day for maintenance. This study hopes to show~     that the addition of night-time compression creates a measurable reduction in arm volume and~     that adding night-time compression to the standard care (daytime compression only) will~     produce improvements in quality of life for breast cancer survivors.~   "
66470|NCT02187276|"~     Background and objectives: The aims of this naturalistic study were: to analyze factors~     which could be predictive of good response to cholinesterase inhibitors (ChEI), such as:~     age, sex, schooling, mild (CDR 1) or moderate Alzheimer's disease (AD),(CDR 2), Apoliprotein~     epsilon 4 (APOE Ɛ4), among others, in their cognitive and clinical response. We also~     classified patients according to their response to Mini mental State of Examination (MMSE).~     Finally we saw the polymorphisms of APO E and cytochrome P450 2D6 (CYP2D6) and tried to~     correlate the response with different allelic forms of Apo E and among others with wild type~     homozygotes (wt/wt) and their polymorphisms (CYP2D6*3,*4, *5, *6 and 10) of CYP 2D6.~      Patients and Methods: 129 patients were diagnosed as AD or AD+cerebrovascular disease (CVD)~     mild or moderate. After 12 month-treatment, 97 patients completed the study. They were~     assessed (four) times. In the first visit, without taking ChEI, after 3, 6 and 12~     month-treatment, they were taking donepezil or rivastigmine or galantamine. We also~     extracted 5 mL of blood sample to genotype the DNA. In each visit, we applied cognitive,~     functional, mood and behavior scales. Good responders were defined as those who scored > 2~     in MMSE.~      Results and Conclusion: In longitudinal analysis, patients with mild AD and good responders~     at 3 months were considered good responders at 12 months. We obtained a higher rate of good~     responders comparing with other researches (27.8%). There was no correlation between dose,~     APOE and CYP 2D6 polymorphisms, although we already obtained clinical results with the dose~     dosage of 5mg.~   "
66471|NCT02187263|"~     This is a joint project by Heidelberg University and Greifswald University.~      Our objective is to establish an unique national multi-center registry and biobank of well~     phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,~     molecular and omics-based phenotyping to serve as:~        1. central hub for clinical outcome studies.~        2. joint resource for diagnostic and therapeutic trials.~        3. common biomaterial bank.~        4. resource for detailed molecular analyses on patients' biomaterials and patient specific~          model systems.~   "
66472|NCT02187250|"~     The purpose of this study was to determine whether monotherapy treatment with~     phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with~     glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in~     the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight~     reduction who have not been treated before. The investigators anticipated greater changes in~     body weight in patients on roflumilast treatment than in liraglutide or metformin.~   "
66473|NCT02187237|"~     The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area~     that emit laser light to reduce the circumference waistline.~   "
66500|NCT02186886|"~     Aim of this study is to determine wether the macromolecular spectral characteristic of~     ulcerative colitis patients - measured by Physiological Intermolecular Modification~     Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment~   "
68550|NCT02160054|"~     To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation~     when converted from cyclosporine~   "
66475|NCT02187211|"~     This is a double-blind, placebo-controlled, outpatient study with a between-groups design.~     Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or~     400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3~     outpatient visits for medication administration, dispensing of take-home doses and~     monitoring of any adverse effects from study medications. On days 8 and 10 of treatment,~     subjects will have 2 laboratory sessions where alcohol or placebo will be administered~     intravenously using a clamp procedure. Alcohol administration will use a breath alcohol~     concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow~     collection of multiple outcome measures including subjective, motor, cognitive measurement~     and plasma cytokine levels.~   "
66476|NCT02187198|"~     This is a randomized, open-label clinical trial with 200 Veteran opioid dependent men and~     women. Veterans will be randomized to one of two treatment groups: low dose range of~     buprenorphine (<8mg) vs. high dose range of buprenorphine (<16mg). During induction into~     buprenorphine, all participants will be started at a dose of 2mg, and this dose will be~     increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low~     dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will~     be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of~     the 12-week study, participants will either be referred to a buprenorphine clinic if they~     wish to continue this medication, or if they wish to be drug free, will undergo~     detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at~     1, 3, and 6 months after study completion, will evaluate the durability of treatment effects~     on drug use and psychosocial outcomes. Veterans will be recruited primarily through~     advertisement, but also through the clinical facilities at the VA and from other~     collaborators.~   "
66477|NCT02187185|"~     This research study has 2 aims. One aim is to see if saliva testing can show if a person has~     healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate,~     or severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush~     on periodontitis.~   "
66478|NCT02187172|"~     The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab~     (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers~     in patients with moderate to severe psoriasis.~      This study will look for systemic vascular inflammation in study participants with a test~     called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The~     study will also look for cardiometabolic identifiers (heart disease and metabolic factors)~     in blood samples, including markers of high cholesterol, cholesterol efflux function (the~     ability of cholesterol to move in the body), metabolic factors, and inflammation.~      The study will also examine the effects of ustekinumab compared to placebo on psoriasis~     activity, severity and safety.~   "
66479|NCT02187159|"~     DS 5565 will be better than placebo (sugar pill without active drug) in managing~     fibromyalgia pain and will be well tolerated.~   "
66480|NCT02187146|"~     The purpose of this study is to investigate whether an association exists between serum~     vitamin D levels and IVF treatment outcome~   "
66481|NCT02187133|"~     This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution~     study to evaluate the safety and tolerability of carfilzomib in combination with~     bendamustine and rituximab in patients with relapsed or refractory NHL and to determine the~     recommended phase II dose and preliminary efficacy of this combination. The study will have~     two phases: a dose-escalation phase to determine the maximal tolerated dose of carfilzomib~     in this combination where participants will be monitored for toxicity, tolerability and~     response and a dose-expansion phase that will determine the preliminary efficacy in patients~     with Mantle cell lymphoma or any other disease subtype in which there is a preliminary~     efficacy signal observed.~      Determination of the maximum tolerated dose (MTD) will follow standard 3+3 design with~     escalation of the carfilzomib dose only (Table 5.2). Dose levels of carfilzomib will be 15~     mg/m2, 20 mg/m2, 27 mg/m2, and 36 mg/m2 IV administered on days 1, 2, 8, 9, 15 and 16. The~     last 2 cohorts will have a starting carfilzomib dose of 20 mg/m2 on days 1, 2. Bendamustine~     will be administered at the well-tolerated dose of 90 mg/m2 IV on days 1 and 2. A dose~     de-escalation of bendamustine to 75 mg/m2 (cohort -1) will occur if the starting dose proves~     intolerable in this combination. Rituximab will be given at a dose of 375 mg/m2 on day 9 of~     Cycle 1 and day 1 of subsequent cycles. Rituximab will be intentionally delayed to day 9 of~     cycle 1 to help facilitate performance of the correlative studies.~   "
66482|NCT02187120|"~     The purpose of this research is to determine whether giving severely injured adults a drug~     called tranexamic acid (TXA) as soon as possible after injury will improve their chances of~     survival and their level of recovery at six months.~      After severe injury, a person may have uncontrolled bleeding that places them at high risk~     of bleeding to death. Coagulation (the formation of blood clots) is an important process in~     the body that helps to control blood loss. Up to a quarter of people that are severely~     injured have a condition called acute traumatic coagulopathy. This condition affects~     coagulation and results in the break down of blood clots (fibrinolysis) that can lead to~     increased blood loss and an increased risk of dying.~      TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic~     coagulopathy by preventing blood clots from breaking down and helping to control bleeding.~     In Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to~     reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e.~     cardiac surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial~     (CRASH-2) showed early treatment with TXA reduced the risk of death in severely injured~     patients, however the majority of patients involved in the study were injured in countries~     where prehospital care is limited and rapid access to lifesaving treatments is limited~     compared to that available in countries like Australia and New Zealand. It is unclear~     whether TXA will reduce the risk of death to the same degree when it is given alongside~     other lifesaving treatments that are available to patients soon after injury in these~     countries.~      The hypothesis is that TXA given early to injured patients who are at risk of acute~     traumatic coagulopathy and who are treated in countries with systems providing advanced~     trauma care reduces mortality and improves recovery at 6-months after injury.~   "
66483|NCT02187107|"~     The purpose of this study was primarily to assess the long-term safety and tolerability of~     TMC114/rtv in addition to an individually optimized background antiretroviral therapy in~     HIV-1 infected participants. In addition, antiviral activity and immunological effect were~     also evaluated.~   "
66484|NCT02187094|"~     Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic~     disorder that slows or stops the passage of food from the stomach to the small intestine.~     The purpose of this study is to test whether TC-6499 is safe and effective at reducing~     gastric emptying time in diabetic subjects with gastroparesis.~   "
67668|NCT02171611|"~     To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on~     food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution,~     both with 150 mg of dabigatran etexilate as capsule in healthy volunteers~   "
66485|NCT02187081|"~     Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in~     diameter. However, the long-term prognosis is not satisfactory due to the high incidence of~     recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with~     locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug~     associated with improved overall survival (OS) in patients with advanced HCC. Retrospective~     and randomized studies have suggested that the combined use of Sorafenib may be useful in~     patients with unresectable HCC. Based on these information and the multiple actions of~     Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to~     Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination~     Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1~     HCC in a multicenter prospective cohort study.~   "
66486|NCT02187068|"~     The aim of this study is to characterize, using two different modeling approaches, one based~     on purely statistic concept and one using a more mechanistic analysis, the influence of body~     weight and composition on the pharmacokinetic of dexmedetomidine.~   "
66487|NCT02187055|"~     To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as~     compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy~     compared to tofacitinib combined with methotrexate. To compare effects on all health~     outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and~     adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of~     tofacitinb or adalimumab.~   "
66488|NCT02187042|"~     220 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib~     (Sutent) will be randomized into two arms :~        -  Control arm: Followed with standard care~        -  Experimental arm: Followed with standard care plus a call center~      Principal assumption : reduce the percentage of adverse events of grade 3, 4 by 20% between~     the control arm (60%) and the experimental arm.~   "
66489|NCT02187029|"~     The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid~     in subjects suffering from gout following 14 days of dosing, as well as assessing safety and~     tolerability.~   "
66490|NCT02187016|"~     The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal~     cleaning modalities with and without chemistry on oral health over 28 days.~   "
66491|NCT02187003|"~     This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in~     treating subjects with sickle cell disease (SCD) who are 6 years of age or older~     experiencing a pain crisis necessitating hospitalization.~   "
66492|NCT02186990|"~     The purpose of this study is to evaluate the effect of propofol, etomidate and~     propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal~     intubation and assess the adverse effect related to this drugs.~   "
66493|NCT02186977|"~     A proof of concept (POC) study will be conducted in 44 volunteers that have been fully~     vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and~     immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a~     newly developed intradermal injection device VAX-ID, compared to intramuscular and~     intradermal (Mantoux technique) injection.~   "
66494|NCT02186964|"~     Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen~     in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is~     found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.~      There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in~     between those methods is the closing of the defect that occurs after the excision of the~     sinus tract. The defect can be closed by primary sutures or it can be left for secondary~     healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap~     procedures are commonly used. However, it has been reported that there is no difference~     between flap procedures and tension free primary closure. This result triggered the~     controversy that; if the healing side is tension free, midline suturing may have no~     importance. The aim of this study is to compare the results of 3 different surgical~     procedures used in treatment of pilonidal disease.~   "
66495|NCT02186951|"~     Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with~     shockable rhythm. In mechanically ventilated patients who were resuscitated after~     out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive~     for infectious complications and especially for ventilator-associated pneumonia (VAP).~      Despite high incidence of VAP and other infectious complications, it is not currently~     recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could~     be decreased if an antibiotic therapy was systematically given to patient treated with mild~     therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less~     infectious complications but also decreased morbidity and mortality related to these~     complications when antibiotic therapy was given early to patients treated with therapeutic~     hypothermia after cardiac arrest.~   "
66496|NCT02186938|"~     This study aims to investigate whether the intraoperative use of the FloTrac device to guide~     fluid and vasopressor management during head and neck free flap surgery improves~     postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary~     postoperative outcomes include days in ICU, days on ventilator, presence of postoperative~     pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap~     complication rate, inpatient postoperative cardiorespiratory complications/events, and~     overall 30 day flap failure rate.~   "
66497|NCT02186925|"~     Identifying clinical factors such as medication, background diseases and blood tests that~     effect the course of disease in cancer patients can help physicians to better decide on the~     patient's treatment plan. The study seeks to identify and analyze relevant clinical factors~     that effect the course of the disease and the results of treatment in patients with cancers~     of the prostate, bladder and kidney.~   "
66498|NCT02186912|"~     Indication : edentulous patients To evaluate and compare the marginal bone level change~     around tilted and straight NobelActive implants placed in healed sites with~     All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge~     (fixed) in the mandible and maxilla.~   "
66499|NCT02186899|"~     Arthroscopic ACL repair can be performed under different types of anesthesia. In the last~     few years peripheral nerve blocks have increased their popularity for this kind of~     operation. The investigators want to see how the type of anesthesia and postoperative~     analgesia effects the time required for patient mobilisation.~   "
66502|NCT02186860|"~     Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for~     fighting cancer. Many people do not respond to the standard treatments of ALL. One possible~     treatment is chimeric antigen receptor (CAR) modified T cell infusions. Third generation~     CAR-T which contains Cluster of Differentiation 28 (CD28) and Cluster of Differentiation 137~     (CD137) has stronger effect of anti-tumor capacity compare with second generation CAR-T. The~     investigators believe that the cells with CD28 and CD137 will have a better chance of~     killing the lymphoma cells. In the lab, the investigators constructed a third generation CAR~     containing both CD28 and CD137. The investigators start Phase I study aimed to chemotherapy~     resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is~     to assess the safety and effectiveness of third generation CAR-T cells in patients.~   "
66503|NCT02186847|"~     This randomized phase II trial studies how well chemotherapy and radiation therapy given~     with or without metformin hydrochloride works in treating patients with stage III non-small~     cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and~     keep them from coming back. It is not yet known whether chemotherapy and radiation therapy~     is more effective when given with or without metformin hydrochloride in treating stage III~     non-small cell lung cancer.~   "
66504|NCT02186834|"~     The main purpose of this study is to see whether the combination of Selinexor (KPT-330),~     liposomal doxorubicin and dexamethasone can help people with relapsed and refractory~     Multiple Myeloma. Researchers also want to find out the combination of Selinexor (KPT-330),~     liposomal doxorubicin and dexamethasone is safe and tolerable.~   "
66505|NCT02186821|"~     The purpose of this signal seeking study is to determine whether treatment with ceritinib~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
66506|NCT02186808|"~     The objective of the study is to evaluate the clinical performance of Procera® Bridge~     Zirconia veneered with NobelRondo Zirconia.~   "
66507|NCT02186795|"~     The goal of this retrospective chart review is to evaluate if the implementation of lumbar~     plexus block placement for postoperative pain and administration of multimodal oral~     analgesia have improved conditions in the postoperative period for patients undergoing total~     hip arthroplasty when compared to the placement of epidurals for postoperative pain~     management.~   "
66508|NCT02186782|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile~     women.~   "
66509|NCT02186769|"~     A review of the amount of drug in your blood over time.~   "
66510|NCT02186756|"~     The purpose of this study is to determine whether EMG-Biofeedback is effective in the~     treatment of Fibromyalgia.~   "
66511|NCT02186743|"~     The primary objective of the clinical trial portion of this study is to assess whether an~     individualized dietary plan based on a commercial food sensitivity assay provides specific~     benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).~   "
66512|NCT02186730|"~     This study forms the second phase of previous work to examine the effectiveness of~     computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low~     mood/depression.~      Depression affects around 2% of adolescents. Antidepressants are not recommended for this~     age range as a first line treatment because of concerns about their usefulness and side~     effects. Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which~     is effective and one of the main treatments recommended for depression. It has been~     suggested that computerised versions of CBT (cCBT) may be effective for treating depression~     in young people who may prefer this to seeing a therapist face-to-face, but little research~     exists to date to support this. This study examines the feasibility of running a large scale~     randomised controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with~     self-help websites for adolescents with low mood and depression (LMD).~      Eligible and consenting participants will complete several questionnaires to assess their~     mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to~     selected websites providing self help for LMD. Participants will complete further mood~     questionnaires 4 and 12 months after treatment completion/withdrawal. We have already~     recruited 97 individuals to this trial but aim to recruit a further 48 participants to~     collect further information.~      We are also keen to find out whether sending participants text messages before sessions and~     around follow up periods will increase attendance/completion. Therefore all trial~     participants will receive text messages from the research team during their participation.~   "
66513|NCT02186717|"~     The specific aim of this prospective, randomized controlled trial is to compare the effect~     of chewing gum on the return of bowel function in a group of patients undergoing spinal~     surgery with a group of matched controls that do not receive any chewing gum. A 24-hour~     reduction in time to passage of first flatus will be considered an important clinical~     difference.~      The research questions are:~        1. Does providing chewing gum post-operatively hasten the return of bowel function?~        2. Does providing chewing gum post-operatively reduced overall length of stay?~        3. Does providing chewing gum post-operatively have any associated complications?~        4. Does providing chewing gum post-operatively result in higher objective outcomes scores?~      The secondary aims are:~        1. To compare hospital length of stay between the groups with a mean of ½ day considered~          clinically important.~        2. To compare time until tolerating regular diet as defined as two consecutive meals with~          no complications with 24 hours considered statistically significant.~        3. To compare incidence and nature of complications between the two groups.~        4. To compare the time until completion of rehab milestones with 1 day being considered~          clinically important.~        5. To compare the requirement for nutrition evaluations~        6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10~          points or more measured between the two groups upon discharge from hospital and at~          six-weeks after surgery.~   "
66542|NCT02186340|"~     The improvement in inspiratory muscle function might result in beneficial changes in~     breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory~     muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing~     pattern during an incremental cycle exercise.~   "
66515|NCT02186691|"~     Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at~     35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or~     pulmonary regurgitation (PR). It is well established that these lesions can lead to~     irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve~     replacement technique was developed to avoid long term right ventricular dysfunction.~     Pulmonary valve replacement indications are based upon the presence of symptoms at exercise~     and/or morphological or functional parameters such as severe pulmonary regurgitation with~     right ventricle dilatation/dysfunction. The best timing of such intervention is still~     underdebate with the main aim of having the right balance between avoiding long term~     sequelae of PR or PS and being the latter possible to push ahead the need for new~     intervention. Recent publication showed that myocardial diffuse fibrosis can contribute to~     irreversible alteration of myocardial contractility. Quantification of diffuse fibrosis by~     magnetic resonance imaging is feasible and could help the physician to best determine the~     right timing for PVR in this population of patients. Cardiac function assessment at rest and~     during exercise is possible using MR and our centre has developed a program for cardiac~     exercise during MRI. This could help to detect infra clinic abnormality and to analyse~     myocardial adaptation during exercise.~   "
66516|NCT02186678|"~     18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and~     Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as~     dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine~     Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)~     imaging using peptide receptors has gained an increasing role in the management of NETs. The~     use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of~     Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of~     SSTRs-expressing tumors, including PGLs.~      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than~     other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the~     most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and~     68Ga-DOTATATE PET-CT have never been compared in this clinical setting.~   "
66517|NCT02186665|"~     The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to~     8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice~     daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.~   "
66518|NCT02186652|"~     Multicenter, comparative single-dose pharmacokinetic (PK) study~   "
66519|NCT02186639|"~     To answer the question whether a disease specific profile of breath in patients with COPD~     can be detected by an untargeted metabolomic study using exhaled breath analysis by mass~     spectrometry.~   "
66520|NCT02186626|"~     West Nile virus (WNV) is considered an emerging virus in the United States, and infection~     can lead to severe illness in older adults. This study will evaluate the safety of and~     immune response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West~     Nile encephalitis in adults 50 to 65 years old.~   "
66521|NCT02186613|"~     The investigators will conduct a telephone-based support to breastfeeding women with healthy~     newborns to improve breastfeeding outcomes.~   "
66522|NCT02186600|"~     The purpose of this study is to identify the best way to prevent bone loss in the first~     years after menopause. The HOPE study will compare bone loss at 12 months in women: 1) who~     take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication~     risedronate; or 3) who take calcium and vitamin D plus participate in bone-loading~     exercises. Our central hypothesis is that improvements in bone health will be greater in~     women randomized to bone-loading exercises with calcium and vitamin D compared to women who~     take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.~   "
66523|NCT02186587|"~     To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the~     outcomes of patients who receiving an off-the-shelf total knee implant.~      Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data,~     and implanted with CT-navigated custom instruments will show faster functional recovery,~     including gait and patient functional outcome scores, when compared to standard,~     off-the-shelf total knee components inserted with non-navigated instruments (the present~     standard of care in total knee surgery).~   "
66524|NCT02186574|"~     The purpose of the study is to determine how effective preemptive tenofovir therapy is in~     preventing the re-activation of Hepatitis B infection, in patients who are receiving~     rituximab-based chemotherapy for Non-Hodgkin's Lymphoma. The rate of re-activation will be~     compared between patients who receive preemptive tenofovir and patients who receive~     tenofovir as needed.~   "
66525|NCT02186561|"~     The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device~     in the treatment of unruptured, wide-neck intracranial aneurysms.~   "
66526|NCT02186548|"~     Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In~     approximately 2% of the Swedish population they fail to erupt, and are then referred to as~     impacted. One severe complication of impacted maxillary canines is damage (root resorption)~     to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth~     are lost. If the impaction is detected early (at 9-10 years of age), the recommended~     treatment is to extract the deciduous canine, to help the permanent canine to resolve its~     unfavorable position. If there is no improvement of the position of the canine 1 year after~     the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is~     followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine~     into correct position.~      Two different main principles of surgical exposure in palatally impacted maxillary permanent~     canines are the so called closed versus open surgical techniques.~      Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap~     dissected off the bone. The bone covering the canine is being removed and an attachment with~     a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain~     above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The~     canine is orthodontically moved beneath the palatal mucosa by forced eruption.~      Open technique involves surgically uncovering of the canine, removing a window of tissue~     around it and placing pack to cover the exposed area. Then the treatment approaches vary~     depending on whether the attachment with a chain is bonded to the exposed tooth at surgery~     or if spontaneous eruption of the palatally impacted canine is expected postsurgically. In~     both alternatives orthodontic force is applied via the chain and the canine is~     orthodontically moved above the mucosa. These two techniques of surgical exposure of~     palatally impacted canines seem to be the two routinely used in Sweden.~      The purposes of this study are to examine, describe and compare the treatment outcomes in~     regard to success and duration of treatment, complications, side effects, cost-benefit~     aspects and patients´ perceptions in closed versus open surgical exposure techniques, in~     cases with palatally impacted canines.~      The objective is to test the null hypothesis that there are no differences in the above~     outcomes between open or closed surgical exposure of palatally impacted canines.~   "
66527|NCT02186535|"~     The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D~     (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on~     female reproductive tract immunity.~   "
66528|NCT02186522|"~     Patients admitted to intensive care units (ICU) are at high risk of developing secondary~     infections, and this is in part due to dysfunction or failure of their 'germ killing'~     functions (the immune system). Our group has recently identified three signatures of immune~     system failure which can be readily detected on a blood sample, and importantly, appear to~     predict the chances of developing secondary infection. Such a test would have major benefits~     for the management of patients in intensive care if it can be translated into a test usable~     in everyday clinical practice. This study aims to validate our original findings in a cohort~     of patients from multiple ICUs, using a test which will be suitable for everyday clinical~     practice, and thus take the next step towards developing a market-ready test.~      Study hypothesis:~      Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict~     the risk of nosocomial infection.~   "
66529|NCT02186509|"~     This phase I trial studies the side effects and best dose of alisertib when combined with~     fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that~     have returned after previous treatment with radiation therapy (recurrent). Alisertib may~     stop the growth of tumor cells by blocking an enzyme needed for the cells to divide.~     Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery~     uses special positioning equipment to send a single high dose of radiation directly to the~     tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over~     multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue~     while maintaining the advantage of its accuracy.~   "
66530|NCT02186496|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of~     the two separate drugs in healthy male volunteers.~   "
66531|NCT02186483|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Metformin and Rosuvastatin in healthy male volunteers.~   "
66532|NCT02186470|"~     This clinical trial studies intensity-modulated accelerated partial breast irradiation~     (APBI) before surgery in treating older patients with estrogen receptor positive or negative~     and progesterone receptor positive stage 0-I breast cancer. APBI is a specialized type of~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
66533|NCT02186457|"~     The purpose of this study is to determine if the routine use of antibiotic irrigation during~     pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.~   "
66534|NCT02186444|"~     The purpose of this study is to evaluate the impact of providing newly diagnosed prostate~     cancer patients and their caregivers with an interactive mobile tablet technology-based~     application delivered by a community navigator versus providing National Cancer Institute~     (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes~     (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared~     decision making practices (decision making involvement).~   "
66535|NCT02186431|"~     To quantify and compare baseline tear proteins and ocular response in contact lens wearers~     with a history of corneal infiltrative events, to those without a history of complications.~     This will be accomplished via measurement of select anti-inflammatory tear proteins before,~     during and after contact lens wear.~   "
66536|NCT02186418|"~     The purpose of this study is to determine whether transfer of a fetal hemoglobin gene using~     a lentivirus vector (gene transfer) into human blood making cells is safe and feasible in~     patients with sickle cell disease.~   "
66537|NCT02186405|"~     Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and~     normal T4 are less known and the indications for treatment of subclinical hypothyroidism are~     subject to controversies.~      The investigators propose to assess whether the hormone replacement for subclinical~     hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and~     renal functions and which mechanisms are involved.~      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic~     evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried~     out before and 6 months after substitution.~   "
66538|NCT02186392|"~     The purpose of this study is to investigate the impact of exposure to ergonomic circadian~     light on physiological and mental parameters in stroke patients admitted for rehabilitation.~   "
66539|NCT02186379|"~     The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace)~     to help children at risk for obesity (children who eat rapidly and have an overweight~     parent/legal guardian) develop a more normal eating rate.~   "
66540|NCT02186366|"~     Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or~     fear of no explicit object and fixed content, or things that might occur in real life，which~     not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms~     including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as~     psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some~     type of functional disability or decrease in quality of life. GAD is treated by Selective~     Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI)~     and 5-ht1a receptor agonists as regular medication which have the definite effects. But,~     some adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of~     patients with GAD. There is an impressive data suggesting that Abdominal Massage Therapy is~     effective in decreasing some symptoms of somatic symptoms and psychological feelings.~      This study is designed as a parallel group, positive control, non-inferiority study. It will~     recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen~     type. Both the treatment group and the control group will be randomly assigned 70 cases.~     Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the~     control group by buspirone . The total study includes 4 views that are respectively before~     the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the~     whole treatment. At all of the 4 views, all participants will be estimated the scores of~     Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life~     assessment scale. At the second, third and the forth views, all participants will be~     estimated Clinical Global Impression ( CGI). At the first and the third views, all~     participants will be collected the data of content of hydroxytryptamine（5-HT）,~     Norepinephrine and total cortisol in blood plasma, and of blood stream speed, vascular~     resistance index and pulsatility index of middle cerebral artery （MCA）, anterior cerebral~     artery（ACA）, posterior cerebral artery （PCA） and basilar artery（BA）. This study aims to~     investigate the efficacy of Abdominal Massage Therapy vs. buspirone, and discover the~     correlation between these scales and these objective indicators.~   "
66541|NCT02186353|"~     The primary objective of this pilot study will be to examine the effects of consuming whole~     grains, differing in the degree of processing, on insulin sensitivity and other~     cardiometabolic risk factors. The overall aim will be to assess feasibility of the test~     diets and to generate preliminary data.~   "
66543|NCT02186327|"~     This study examines a pilot project to introduce integrative health coaching to two~     community clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke~     Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site~     (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a~     3-month period at no cost by coaching trainees completing their certification hours. Pre and~     post measurements of BMI, patient activation, and perceived interpersonal support will be~     collected and analyzed for interaction effects. Qualitative process evaluation will be~     conducted as a thematic analysis via guided interviews with stakeholders and participants,~     using the RE-AIM framework. Feasibility measures will include recruitment of both coaches~     and clients, subject/client retention, and number and duration of coaching sessions~     completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a~     post-intervention focus group that addresses the impact of coaching on perception of~     health-related resources and needs in the community.~      Primary Hypotheses:~      Integrative health coaching will be a feasible intervention in both community and clinical~     settings, in terms of required resources, patient or client adherence, and satisfaction by~     community stakeholders, including providers and participants.~      Additional hypotheses:~      Individuals who receive integrative health coaching sessions as an adjunct to their standard~     medical care will see improvements in patient activation and perception of interpersonal~     supports, when compared to controls.~      Individuals who receive integrative health coaching (or in the case of the pediatric cohort,~     children of individuals who receive coaching) will see minor improvements in BMI over the~     study period when compared to controls.~   "
66544|NCT02186314|"~     In this study we will select twenty patients with chronic atrial fibrillation and~     ventricular dysfunction with permanent cardiac pacemaker indication. We will dosage serum~     level natriuretic peptides for comparison between conventional and bifocal cardiac pacing.~   "
66545|NCT02186301|"~     The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with~     erlotinib in patients whose tumors have specific EGFR mutations and who have not previously~     received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a~     'Randomized' Study. This means that upon entering the study, patients will be randomly~     assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients~     will continue to take either rociletinib or erlotinib until it is no longer beneficial.~   "
66546|NCT02186288|"~     Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by~     electrical impedance tomography~   "
66547|NCT02186275|"~     The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve~     the outcome (i.e. fewer relapses) and the quality of life, including levels of physical~     activity, in children with newly diagnosed Crohn's disease (CD).~   "
66548|NCT02186262|"~     Grading of gliomas is of significant clinical importance since the prognosis as well as the~     treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI~     modalities, however, a reliable distinction is often impossible. Moreover, the gold standard~     for glioma grading by histopathology may also have limitations due to unrepresentative tumor~     samples. Therefore, more advanced MRI techniques are urgently needed that would have higher~     sensitivity and specificity in the definition of tumor type, grade and extent.~      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria~     12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify~     nonresponding patients earlier, preferentially midtreatment in order to consider alternative~     treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have~     provided promising results in assessing early treatment response. Furthermore, a serum~     biomarker with diagnostic value could improve tumor follow-up and clinical management of~     gliomas.~      The aim of our study is to develop novel imaging protocols suitable for the magnetic~     resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame~     imaging, novel DWI acquisition and post-processing methods We also study the correlation~     between advanced MRI parameters and histopathology of the tumor specimen. In addition, early~     treatment response is assessed with advanced MRI parameters at 3 week and 10 week after~     initiation of radiotherapy. Finally, our objective is to study the association between serum~     biomarkers and corresponding MRI with potential tumor progression.~   "
66549|NCT02186249|"~     The purpose of this study is to provide treatment with nivolumab in combination with~     ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have~     unresectable or metastatic melanoma.~   "
66550|NCT02186236|"~     The purpose of this study is to see whether gene mutations can be found in the urine or~     blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are~     when DNA in a gene is damaged in a way that changes the genetic message carried by that~     gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found~     in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer~     tumors and colorectal cancer tumors are now tested for different gene mutations as their~     presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are~     typically tested for these gene mutations.~   "
66551|NCT02186223|"~     The primary objective of this multicenter, prospective, single arm clinical trial is to~     evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,~     and with recognized contraindications to standard pharmacological therapy (anticoagulation).~   "
66552|NCT02186210|"~     Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial~     injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery~     without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is~     important for clinical outcome. The investigators hypothesized that prewarming during~     induction of general anesthesia would reduce drop of body temperature and change of~     peripheral microcirculation.~   "
66553|NCT02186197|"~     Shock and respiratory failure are common reasons for admission to the intensive care unit~     (ICU) at our institution. The various causes of acute shock and respiratory failure are~     traditionally assessed with the use of history, physical examination, chest x-ray, EKG and~     laboratory studies. Unfortunately, much of this clinical information is either insensitive~     or non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which~     has been shown to be useful in the intensive care unit to assist in the diagnosis and~     management of patients in shock or respiratory failure.2~      The investigators hypothesize that the trained fellow's interpretation of critical care~     ultrasound images will be accurate when compared to experts and that ultrasounds will change~     diagnosis and management of the patient in shock and respiratory failure.~   "
66584|NCT02185794|"~     This study will evaluate the safety, tolerability, and antiviral activity of GS-9857 alone~     or with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2,~     3, or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48~     weeks after the last dose to monitor for persistence of viral mutations.~   "
66554|NCT02186184|"~     Orthokeratology is becoming popular for the treatment of myopia children. Many studies have~     shown that orthokeratology is effective in temporarily reducing refractive error, and is~     also helpful for controlling myopia progression. However, the mechanism for its slowing~     myopia progression and rebound effect after the treatment have not been clearly studied. In~     addition, the effect of orthokeratology among Chinese children has not been evaluated with~     randomized controlled trial.This study is to assess the effect of orthokeratology versus~     spectacles on myopia progression in school-aged Chinese children during two years.~   "
66555|NCT02186171|"~     This is a phase 3 multicenter study to compare the efficacy and safety of Romosozumab (AMG~     785) with placebo in men with osteoporosis.~   "
66556|NCT02186158|"~     Pneumonia is the second common infection and its risk increases for elderly. In this~     population, it is the first cause of mortality by infections, and source of many~     complications. Geriatric studies had shown the high prevalence of ascorbic acid 's~     deficiency, especially in older hospitalized people. It is well known that vitamin C is one~     of the key of the immune system, it has a scavenger's role in case of aggression like~     sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for~     preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory~     symptoms for patients treated by vitamin C, and for one of those studies it was noted a~     significant reduction of mortality. The main objective of our study is first to determine~     the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management~     of pneumonia in older people hospitalized, and then evaluate its impact on functional~     status.~   "
66557|NCT02186145|"~     The purpose of this study is to evaluate the efficacy and safety of association of~     metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal~     infections.~   "
66558|NCT02186132|"~     Balanced general anesthesia with neuromuscular blocking agents has been widely used for~     surgery.. At the end of surgery, neostigmine has been given for the reversal of~     neuromuscular blocking agents with several adverse effects such as bradycardia and profuse~     secretion. Atropine has been used to prevent those side effects of neostigmine. The routine~     dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.~      Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with~     2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was~     increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the~     mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of~     atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32~     bpm. However this study did not report the incidence of bradycardia and blood pressure. The~     mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)~      Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of~     neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest~     heart rate at 40 minutes after administration. This study also did not report the blood~     pressure.~      The baseline heart rate (HR) before administration of the reversal was associated with the~     following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after~     receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal~     of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients~     receiving alcuronium. However, before administration of atropine and neostigmine, the mean~     heart rate of patients was significantly lower in the pancuronium group.~      Either tachycardia or bradycardia with hypotension causes adverse affect to patient~     especially in specific group like patient with coronary artery disease or undergoing~     craniotomy.~      The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood~     pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant~     compare to 1.2 mg atropine.~   "
66559|NCT02186119|"~     This is a safety and efficacy study of abicipar pegol in patients with diabetic macular~     edema.~   "
66560|NCT02186106|"~     Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our~     objective was to determine how to calculate the quantity of cholecalciferol needed for~     supplementation by single algorithm, usable on a patient-to-patient basis.~      We've conducted two studies. Study 1 was done retroactively and included 88 patients treated~     for low vitamin D, 60 of those with a loading dose. The second study included 29 patients~     and aimed to test the validity of an algorithm based on data from study 1, which included~     patient BMI. Both studies used oral loading doses and daily supplementation of~     cholecalciferol.~   "
66561|NCT02186093|"~     There are several physiologic parameters in evaluating cardiovascular disease. This study~     will reveal which parameter is the most proper value in predicting disease severity and risk~     factors of patients.~   "
66562|NCT02186080|"~     This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.~     The investigators will measure systemic endotoxin level and lipid level after ingestion of~     high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic~     endotoxemia and lipemia induced by high fat diet.~   "
66563|NCT02186067|"~     Hypertension has become a public health concern worldwide due to its significant~     contribution to the global health burden and its role as a prominent risk factor for the~     development of a number of chronic diseases such as Cardiovascular diseases (CVD), the~     leading cause of mortality in Pakistan and Worldwide. According to WHO, about 7.5 million~     deaths worldwide is attributable to hypertension i.e. about 12.8% of the total of all~     deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total~     DALYS.~      Studies suggest that hypertension is among the top five most common presenting complaints to~     private general practice clinics. Therefore, primary care physicians/Family physicians are~     the first line service providers and; thus it is important to manage hypertensive patients~     early, through lifestyle and treatment interventions that may prevent the complications such~     as development of CVDs etc.~   "
66564|NCT02186054|"~     The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to~     see how they compare to previously used imaging sequences as they may improve the quality of~     abdominal MRI.~   "
66565|NCT02186041|"~     The purpose of this study is to document the safety, the effectiveness, the continued~     performance at mid and long term, the morbidity and the percent of surgical revisions of the~     Interstim® therapy for up to 5 years in a representative sample of French centers under~     real-life conditions of use.~   "
66566|NCT02186028|"~     The purpose of the study is to evaluate the effect of daily oral supplementation with~     vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various~     studies that vitamin D is highly deficient in Indian mother infant diads. There is a need to~     supplement vitamin D from neonatal period to prevent various metabolic disturbances due to~     vitamin D deficiency in later life. This study aims to find the effectiveness and the~     optimum dose of routine vitamin D supplementation in healthy term newborns for fulfilling~     the normal requirements in Indian infants.~   "
66585|NCT02185781|"~     The present study aims at studying how safe and tolerable a new therapy for patients with~     Acute Lymphoblastic Leukemia (ALL) is.~      This new therapy consists of an immunotherapy, that is an approach focusing on the immune~     system, and it targets ALL patients in complete remission but who may still have the disease~     at a cellular level (this is called 'minimal residual disease').~      For any further information, please, discuss with your treating physician.~   "
66567|NCT02186015|"~     Background: Several clinical trials are underway to investigate if variable forms of vitamin~     D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the~     side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer,~     specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential~     safety purposes, these trials predominantly exclude women with metastatic breast cancer~     (MBC); a rapidly expanding sector of the cancer survivor population who experience~     significant treatment-related side-effects. Evaluation of the safety of vitamin D3~     supplementation is crucial since supplementation can lead to high calcium and importantly,~     in lab studies have shown that vitamin D3 affects a gene that increases estrogen production.~     To assure that vitamin D3 does not affect the clinical effects of anti-estrogen therapies,~     the effect of vitamin D3 supplements on estrogen production requires an evaluation that~     further explores and defines its potential role in symptom management for this population.~      Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in~     women with MBC, providing much needed data on the preliminary safety and efficacy of this~     treatment in this patient population. This study will determine: 1) if weekly~     supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse~     effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation~     on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated~     with improved inflammation (exploratory aim.)~      Methods: This is an 8 week proof of concept study to monitor important laboratory~     parameters and to assess potential effects on short-term outcomes. Adult, female patients~     (>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D < 30~     mg/dl will be recruited from within and around LUMC. Following current clinical practice~     guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks.~     Laboratory values, muscle function and inflammation will be examined pre- and~     post-supplementation, while symptoms (e.g., pain, sleep, fatigue, mood, and overall quality~     of life) will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if~     increases in vitamin D are associated with clinically significant changes in serum~     estradiol, improvements in symptoms and QOL, and decreased inflammation, controlling for~     sunlight exposure, diet, physical activity and body composition.~   "
66568|NCT02186002|"~     The primary objective of the study was to evaluate the safety and tolerability of ACT-451840~     in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics~     (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate~     the urinary excretion of ACT-451840 and to investigate the antimalarial activity of~     ACT-451840.~   "
66569|NCT02185989|"~     Early mobilization (from the first day if possible), first passive and then passive and~     active, is recommended for critically ill patients in whom it reduces the duration of~     mechanical ventilation, the length of hospital stay, improves functional status, muscle~     strength and quality of life after hospital discharge. The early addition of leg bicycling~     on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve~     muscle strength and further increase the beneficial effects of early mobilization.~     Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units,~     and it should, in theory, also through an improvement of muscle strength, increase the~     beneficial effects of early mobilization.~      We hypothesized that early quadriceps electrical stimulation and early work on a~     cyclo-ergometer associated with a standard protocol of early passive/active mobilization in~     the ICU may improve muscle function and reduce the duration of mechanical ventilation,~     length of stay, the number of readmissions and improve the quality of life in the mid term~     in critically ill patients, as compared to a conventional protocol of early passive/active~     mobilization.~   "
66570|NCT02185976|"~     Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a~     special group who need special attention. Some studies have shown that cartoons are a very~     good tool for distraction in the preoperative period for children.~      Our hypothesis is that children watching Cartoons in the preoperative period will have less~     anxiety and will be fit with preparation.~   "
66571|NCT02185963|"~     The patients who have achieved LDL-C levels below the currently recommended targets may~     still experience cardiovascular events. To reduce further the risk of coronary heart disease~     (CHD), raising HDL-C and lowering TG may be the secondary therapeutic target. However,~     increased HDL-C levels do not mean increase in functional HDL-C. It also remains~     controversial whether functional HDL is more important than total circulating levels of~     HDL-C in reducing CHD.~      Actually, the increased concentration of HDL alone might be ineffective indicating that~     qualitative changes in HDL levels in response to drug interventions are required to result~     in clinical benefit.~      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment~     on functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.~   "
66572|NCT02185950|"~     Burning produces changes in the biomechanical properties of the skin causing limitation of~     movement. The increase in skin suppleness is very important in the rehabilitation process,~     since its increase makes therapeutic interventions aimed at increasing the range of motion,~     thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80~     years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão~     Preto. There will be a traditional physical therapy evaluation as well as evaluation of the~     specific characteristics of the burn and scar. The temperature of the region will be~     assessed by thermography, and biophysical parameters and biomechanical skin evaluated by~     Cutometer and their accessory probes (mexameter, reviscometer, sebometer) before,~     immediately after and 10, 20 and 30 minutes of application of therapeutic resources.~     Volunteers will undergo continuous application of ultrasound with 3 MHz and intensity of 1~     W/cm2 in the region due to scar deep second degree burn or third degree, and the application~     time of 2 minutes for each effective radiation area of the head (ERA) in a predetermined~     region of 9X5 cm a total of 4 minutes of application, therapy paraffin 20 minutes and 4~     minutes endermology negative pressure between 100 and 200mmHg, in a continuous mode with~     glass head (1.5cm in diameter .) Applications will be set by random draw (design crusader~     cross-over) with an interval of 7 days between applications (wash-out). The data will be~     submitted to analysis of normality by the Shapiro-Wilk test, and the behavior of the effect~     between groups and pre-and post-intervention will be evaluated by two-way ANOVA followed by~     post-hoc (Bonferroni) or Friedman, p <0.05~   "
66586|NCT02185768|"~     The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and~     epirubicin (12%). But until recently, there were no obvious reasons to use one product over~     another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular~     carcinoma], which does not allow any argument in favour of the product. Moreover, 2~     randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative~     in terms of survival.~      Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to~     select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including~     those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be~     the most effective in vitro by far. The superiority of idarubicin (as opposed to~     doxorubicin) was noted especially on the SNU-449 line, which is known for its resistance to~     several chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2~     mechanisms: 1) idarubicin has a better intracellular penetration than the other~     anthracyclines. This is probably due to its more considerable lipophily, facilitating thus~     its passage through the membrane made up of a double lipid layer, 2) idarubicin is resistant~     to the multidrug resistance system (MDR). The MDR mechanism, which is often noted in HCC,~     consists of membrane pumps transporting the molecule outside the cell. These two~     particularities could explain a more significant accumulation of idarubicin in the HCC~     cells, and thus better efficacy. It is interesting to note that orally administered~     idarubicin (5 mg/day for 21 days) has proved to be less toxic and is effective in HCC.~     Currently, idarubicin is used to treat leukaemia. Its toxicity profile (especially,~     haematological and cardiac) is known.~      On these grounds, A pilot study has been conducted in order to assess the tolerance and~     efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with~     unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and~     less toxic.~      Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC~     Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The~     DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21~     patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the~     idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10~     mg dose is compatible with the known toxicity profile of idarubicin: cumulative~     cardiotoxicity of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted~     from 93 mg/m². There is thus a 5.9:1 ratio between their cumulative toxicities. The most~     frequently used dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The~     equivalent of the idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9~     (doxorubicin/idarubicin ratio) = approx. 10 mg of idarubicin.~      It has been already demonstrated that hepatic extraction of idarubicin is better than those~     of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC~     0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was~     35% higher.~      The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by~     doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised~     trial on CHE published. The PRECISION V data can be thus used to compare the other studies~     in terms of efficacy and tolerance.~      To continue our preliminary study and the phase I IDASPHERE study, investigators wish to~     assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of~     HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.~   "
66587|NCT02185755|"~     Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to~     minimize health problems and complications. One way for patients to notify doctors and~     receive feedback about their blood sugar management is through an online system. As~     Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective,~     the investigators hypothesize that IBGMS is effective as an intervention even when limiting~     feedback to non-medicine related changes.~   "
66785|NCT02183181|"~     Primary Objective:~      To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg~     (Reference, R) following oral administration.~      Secondary Objective:~      To investigate the safety and tolerability of meloxicam following a single dose of meloxicam~     capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese~     subjects.~   "
66573|NCT02185937|"~     The most common sites for GIST to occur are the stomach (60-70%) and proximal small~     intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor~     resection or palliative surgery which might affect imatinib exposure. Indeed, Yoo et al.~     showed that steady state imatinib trough levels in patients with advanced GISTs after major~     gastrectomy are lower compared to patients with a previous wedge resection or without~     gastric surgery. Patients that underwent major gastrectomy had an average imatinib plasma~     trough levels below 1000 µg/L. This while imatinib trough levels above 1000 µg/L are~     correlated to more beneficial treatment out-comes (longer Progression Free Survival).~      Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid~     secretion might be causing the decreased exposure in the patients that underwent major~     gastrectomy.~      Therefore the investigators would like to study if the exposure to imatinib in patients~     after major gastrectomy can be improved by creating a more acidic environment for absorption~     through combining imatinib intake with Coca-Cola.~   "
66574|NCT02185924|"~     Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine~     consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,~     transfusion requirements , Range of motion and rehabilitation parameters between two groups~   "
66575|NCT02185911|"~     To describe anaemia correction via haemoglobin measurements taken throughout observation~     period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM~   "
66576|NCT02185898|"~     This study will assess environmental emissions of selected compounds in a test chamber after~     cigarette smoking or e-cigarette vaping.~   "
66577|NCT02185885|"~     STUDY HYPOTHESIS~      In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by~     increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.~      BRIEF STUDY SUMMARY~      Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain.~     Previous studies using brain scans have reported small stroke-like lesions in up to 51% of~     patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of~     severe brain damage.~      The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in~     blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow~     to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB~     usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since~     sufficient total blood flow is guaranteed during CPB.~      The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or~     reduce the extent of brain injury after cardiac surgery. A beneficial effect could result~     from reduced embolic injury through increased blood flow in collateral vessels and/or by~     increased blood flow in calcified arteries.~      180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP~     (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow~     is intended equal and fixed in the two groups. Patients are examined before and 3-6 days~     after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood~     borne markers of brain injury.~      If higher MAP during CPB is beneficial, a change of practice can easily be implemented in~     the clinical routine.~   "
66578|NCT02185872|"~     The purpose of this study was to examine the differences in glucose control, fitness, and~     body composition between a standard aerobic and resistance exercise training program and a~     shorter-duration, high-intensity CrossFit training program in overweight and obese~     physically inactive adults.~      Hypotheses:~        1. Both groups would improve glucose control, with the CrossFit group improving~          significantly more than the aerobic and resistance training group.~        2. Both groups would improve fitness, with the CrossFit group improving significantly more~          than the aerobic and resistance training group.~        3. Both groups would demonstrate decreases in body fat percentage and fat mass and~          increases in lean body mass, with the CrossFit group improving significantly more than~          the aerobic and resistance training group.~   "
66579|NCT02185859|"~     Postsurgical pain is a relevant side effect following surgery which increases the risk of~     various complications and delays postoperative patient recovery. Among the many types of~     surgeries, mastectomy causes not only acute but also chronic pain in many patients.~     Therefore, it is important to control pain and increase patients' recovery satisfaction~     following many kinds of operations by using as small an opioid analgesic dose as possible~     and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among~     nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be~     helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical~     stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve~     postoperative pain control by reducing postoperative pain and opioid consumption. Another~     report showed that an intraoperative intravenous injection of lidocaine improved the quality~     of postoperative functional recovery after general anesthesia in a laparoscopic~     cholecystectomy patient. In addition, a review article on the effect of intraoperative~     intravenous injection of magnesium found it to be an effective analgesic that may be added~     to conventional opioid-based therapy because it generally reduces opioid consumption,~     decreases pain assessment for 24 hours after surgery, and lacks severe side effects in~     relation to magnesium administration. However, there has been insufficient research~     comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of~     which is more helpful for general functional recovery and decreased postoperative pain.~     Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery;~     to help patients return to daily life, the research trend is now shifting from the~     improvement or resolution of a specific symptom to the measurement of general recovery. A~     widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40)~     survey.~      Therefore, in this study, the researchers investigated the intraoperative intravenous~     injection of lidocaine and the intravenous injection of magnesium to compare these drugs'~     helpfulness in the functional recovery of mastectomy patients after general anesthesia.~   "
66580|NCT02185846|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the~     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence~     interval statistical evaluation.~   "
66581|NCT02185833|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the~     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence~     interval statistical evaluation.~   "
66582|NCT02185820|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM)~     patients.~   "
66583|NCT02185807|"~     The investigators will investigate whether video-assisted informed consent is superior to~     routine discussion for cataract patients about risks, benefits and alternatives to receiving~     phacoemulsification cataract extract and intraocular lens implantation, and will determine~     whether video-assisted informed consent can reduce the work load of physicians.~   "
66786|NCT02183168|"~     Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam~     tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients~     with ankylosing spondylitis~   "
66588|NCT02185742|"~     Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and~     Suppression) is a project to improve the connection to community care for HIV infected~     persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.~      Hypothesis: Participants who receive the intervention will be more likely to link to medical~     care after jail release than similar participants who do not receive the intervention.~      Rationale and objective: This project aims to make sure HIV positive persons leaving jail~     maintain medical care. Case managers will use strength based case management and phone~     texting technology to improve release's connections to care in the community.~      This study will have extensive tracking of outcomes. The key outcome will be whether HIV~     infected participants receiving an intervention experience suppression of their viral load~     after release from jail . The investigators wish to demonstrate the ability to recruit~     participants into the SUCCESS intervention and repeatedly check community medical records to~     see how well their infection is being controlled after they linked to care. Investigators~     also want to conduct a survey at baseline, 3 months and 12 months.~      Investigators will compare the viral load of participants receiving the intervention to~     participants passing through the jail who do not receive the outcome.~   "
66589|NCT02185729|"~     Many patients in the hospital who are malnourished or not eating received intravenous~     feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase~     the risk of infections and hospital complications. We do not know why TPN increases hospital~     complications, but it may be caused by the high sugar or fat content in TPN solutions. The~     investigators believe that the high sugar and high fat content can limit the ability to~     fight infections and produce stiffness of blood vessels. This study will compare the effect~     of high sugar, high fat content or both on blood sugars, blood vessel function, on blood~     vessel function. The investigators will also compare the effect of different fats (olive oil~     and soybean) in the TPN solution on the risk of infection and blood vessel function on a~     total of 12 healthy subjects.~   "
66590|NCT02185716|"~     Postoperative pain is a significant cause of increased morbidity in the perioperative~     period, leading to patient discomfort and greater hospital length of stay. Laparoscopic~     cholecystectomy associated with significant postoperative pain, a substantial component of~     which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has~     been used for providing pain relief following abdominal surgeries. We designed this study~     with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic~     cholecystectomy provides superior analgesic effects than port-side infiltration.~      In this randomized and double-blind study, 75 patients who are in American Society of~     Anesthesiology (ASA) I-II risk group, between the ages of 20-60, and who will undergo~     elective laporoscopic cholecystectomy operation under general anesthesia will be accepted.~     The patients will be divided into three groups and they will be given postoperative pain~     treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8,~     12, 16 and 24,VAS I (superficial pain), VAS II (deep pain), postoperative total analgesic~     proportion, nausea, and vomiting will be recorded under evaluation Postoperative sedation~     score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative~     1, 2, 4, 8, 12, 16 and 24.~   "
66591|NCT02185703|"~     The main purpose of the study is to evaluate the impact of treatment with the Chordate~     System S020 (medical device) on acute migraine headache pain.~   "
66592|NCT02185690|"~     MEK162 has shown significant inhibition of tumor growth as a single agent in NSCLC xenograft~     models in mice and human cancer cells in vitro, which have KRAS and/or other mutations.~     These data suggest that MEK162 may provide a potential benefit in cancer indications~     harboring these mutations. MEK162 is currently being investigated in phase I clinical~     testing and has been well tolerated up to an MTD of 45mg BID in cancer patients.~      There has been little change in survival benefit for patients with non-small cell lung~     cancer in recent years. Emerging new treatment options relying on molecular and genetic~     markers are being studied extensively. Thus, there has been a shift to manage non-small cell~     lung cancer with molecular targeted therapies in combination with standard chemotherapy.~     This study will be targeting patients with KRAS mutations.~   "
66593|NCT02185677|"~     The main objective of the study is to compare the score to the Behavioral Dysexecutive~     Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and~     cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 3~     years) and sex .~   "
66594|NCT02185664|"~     Cannulation of the internal jugular vein (IJV) for central venous access is a standard~     practice in cardiac surgery. In this study, the authors tested the hypothesis that using an~     ultrasound (US) scanner would increase the success of IJV cannulation and decrease the~     incidence of complications in adult cardiac surgical patients.~      The study will include adult cardiac surgical patients, randomized into two groups (control~     vs. US). In the control group, IJV cannulation will be performed by the conventional~     landmark technique using Seldinger method. In the US group, the course of the IJV will be~     marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The~     success rate, number of attempts, cannulation time and complication rate will be compared~     for the two groups.~   "
66595|NCT02185651|"~     Hypothesis: the effectiveness of treatment of Pompe disease with rhGAA enzyme replacement~     therapy (ERT) is limited at least in part because patients develop antibodies against the~     provided rhGAA enzyme. Treatment with Zavesca® prior to infusion may dampen or eliminate the~     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT~     efficacy.~      Treatment with Zavesca® before a enzyme replacement therapy (ERT) may decrease the severity~     of, or eliminate infusion associated reactions (IAR) in people with Pompe Disease receiving~     ERT.~   "
66596|NCT02185638|"~     Background:~      Supplementation with the combination of Yerba maté, guarana and damiana (YGD) has been found~     to slow gastric emptying by 15 to 58%, and to induce a substantial weight loss over 45 days~     without changes in diet. Enhanced gastric emptying rate has been shown to reduce the~     satiating effect of food and may thereby promote obesity. Yerba maté and guarana are known~     to contain large amounts of caffeine, resins, saponins and tannins, whereas damiana contains~     ethereal oils, tannins and resins. Caffeine belongs to a class of compounds called~     methylxanthines and epidemiological studies suggest that caffeine might possess weight~     reducing properties. The sympathomimetic properties of caffeine act to some extent through~     α- and β-adrenoreceptors, but most of the sympathoadrenergic stimulation caused by caffeine~     (even in very small doses) acts through the dual ability to antagonise adenosine and to~     inhibit the activity of cellular cyclic nucleotide phosphodiesterase. Stimulation of the~     sympathetic nervous system can cause suppression of hunger, enhance satiety and increase of~     energy expenditure covered in part by increased fat oxidation.~      Aim:~      To evaluate the effect of YGD combination or Akavar 20-50 (A20-50) compared with placebo on:~        1. Acute change in 4-h subjective appetite sensations~        2. Acute change in ad libitum energy intake (EI) 30 minutes post intake~        3. Acute change in serum glucose, insulin, ghrelin and other appetite-regulating hormones~          (glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK))~      Subjects:~      19 , healthy, premenopausal, overweight to obese (BMI between 27 and 32 kg/m2) women(age: 18~     to 45 years).~      Method:~      The study is designed as a 3-way crossover, randomized, placebo controlled, double-blind~     study.~      The bioactive components will be administered as capsules containing YGD or A20-50. The~     placebo capsules will contain rice flower. The subjects will undergo following treatments:~        1. YGD capsules~        2. A20-50 capsules~        3. Placebo capsules~      On each test day the subjects will be instructed to rest in a supine position for 15 minutes~     before dual measures of blood pressure and HR. A blood sample will be taken (baseline). The~     subject's appetite sensations will also be assessed by visual analogue scales (VAS) prior to~     intake of the test compound. Immediately hereafter the subjects will be served the first~     dose of the test compound. Blood samples will be taken at 15 and 30 minutes (time 0) post~     test compound. After 30 minutes post test compound the subjects will be given a standard~     breakfast (2.5 MJ = 598 kcal). Additional blood samples will be taken 15 minutes 30, 45, 60,~     90, 120, 150, 180 and 240 minutes post-meal, together with a VAS appetite score assessment~     (0, 30, 45, 60, 90, 120, 150, 180 and 240 minutes).~      Immediately after the last blood collection subjects will be asked to take a second dose of~     the test compound. After 30 minutes the subjects will repeat one VAS score assessment and be~     served an ad libitum lunch.~      Blood samples will be analyzed for insulin, glucose, and appetite regulating hormones such~     as glucagon-like peptide-1 (GLP-1), ghrelin, cholecystokinin (CCK).~   "
66597|NCT02185625|"~     The purpose of this study is to determine whether use of the Safe Delivery smartphone~     application by midwives can reduce excess blood loss from bleeding, and infant death during~     childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery~     application can increase midwives' knowledge and skills in managing childbirth.~      Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe~     Delivery application (intervention), or to no intervention (control). In the intervention~     hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be~     enrolled at delivery and followed until 7 days postpartum. Data collection will begin July~     2014 and is expected to be finished by October 2014.~   "
66598|NCT02185612|"~     The current literature in social epidemiology and public health suggests that low financial~     savings has an unsurprising negative relationship with subjective well-being, and increases~     the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis,~     and experiencing medical disability. Earn.org is a community-based non-profit based in San~     Francisco with a mission to help low-income workers build lifelong savings habits and~     financial capability. The organization is one of the largest providers of goal-based~     savings accounts or matched savings accounts in the US. The investigators propose to~     conduct a randomized controlled trial to determine the health effects of Earn's savings~     program. Through this trial, the investigators will test three principal hypotheses: (1)~     Participants in the Earn account, as compared to a control group, are hypothesized to~     demonstrate improved scores on mental health scales assessing depression and anxiety.~      (2) Participants in the Earn account, as compared to a control group, are hypothesized to~     experience lower odds of harmful behaviors associated with stress, specifically tobacco and~     alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller~     effect size, and more delayed, than the effect on mental health outcomes, judging from~     similar effects observed in the micro-credit literature.~      (3) The mediating variables between Earn account participation and beneficial health~     outcomes will include increased optimism and internal locus of control.~   "
66599|NCT02185599|"~     The study will observe and quantify shifts in colposcopy practice and outcome improvements~     in U.S. community-based cervical screening colposcopy examinations after the introduction of~     the DySIS colposcope with Advanced Cervical Scan.~      The study will collect colposcopy data across multiple sites in two arms; a prospective arm,~     with DySIS being used for the examination and a retrospective arm, with data retrieved from~     patient charts.~   "
66600|NCT02185586|"~     We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account~     to this new method, the three incisions are all located on the lower abdominal,~     theoretically it could get more beautiful outlook and less stress response than traditional~     laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single~     port laparoscopic cholecystectomy(one large incision located on umbilicus).~      We plan to conduct a randomized controlled trial to compare those there methods of~     laparoscopic cholecystectomy, in order to find out if there will be some advantages of this~     new method,such as in lowering the stress response,reducing impact on respiration, relieving~     post-operation pain and improving appearance.~   "
66601|NCT02185573|"~     Three clinical groups will be evaluated. Each group of patients will undergo one method of~     Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -~     Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is~     going to be made between the three groups in relation to the modified United Sates Public~     Health Service (USPHS) criteria of good restorations.~   "
66602|NCT02185560|"~     This is a non-interventional, multi center post-authorization safety study that includes all~     patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with~     Sorafenib within a certain period. The investigator should have made the choice of treatment~     (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this~     study.~      The enrollment period is of 9 months. The observation period for each patient starts when~     the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is~     no longer possible (e.g. lost to follow-up); this will be considered the standard~     observation period. Those patients, to whom a total of 24 month follow up is possible,~     information on effectiveness including treatment duration and survival status of the patient~     and of keratoacanthoma and/or squamous cell cancer development will be collected.~   "
66603|NCT02185547|"~     This study targets women with moderate depression during pregnancy. We aim to investigate~     the direct effect of the newborn child and the long term consequences on the cognitive~     developement on children who´s mother has been treated with CBT alone or in combination with~     antidepressants.~   "
66604|NCT02185534|"~     This study will be an open-label, randomised, three-way crossover study in healthy male and~     female subjects, performed at a single centre. The objective of the study is to assess the~     bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister~     from KRKA) and two reference formulations (Clopidogrel 75 mg tablet [Plavix, sourced in US~     and Japan]).~   "
66605|NCT02185521|"~     Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor~     (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill~     patients, who were not previously known to be at risk. This algorithm provides with the~     numerical index - Hemodynamic Instability Index (HII) and its trend which are calculated~     from existing real time data derived from patient's current hospital stay such as heart rate~     and blood pressure, labs, and Admission - Discharge- Transfer (ADT) data to help healthcare~     providers obtain information about patient's status and make clinical decisions.~      The aim of the study is to determine if the patient clinical information, displayed in the~     form of HII, can prompt possible patient hemodynamic status change and trigger earlier~     clinical care team response. Study will also identify if the use of the Philips new~     algorithm called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve~     outcomes for patients admitted to the intensive care units (ICUs).~      During this study, upon patient admission to the ICU clinical data collection will begin.~     Data that will be pulled during the study includes: vital signs, medications, reason for~     admission to the ICU, results from blood work, treatments that patient may receive.~      Research subjects will not be asked to do anything as far as specific activities expected to~     be accomplished during study participation. Subjects will be involved in the study only~     during their stay in ICU. HII information will be visible to clinicians, taking care of this~     patient only during his/ her stay in the study unit. Patients will be randomized into HII~     arm (treatment group) and into no-HII - standard treatment arm (control group).~      Study team will collect patient information and have the ability to view the HII for~     subjects randomized into HII group arm. For subjects randomized into the control arm study~     team will collect patient's clinical information but the clinical care team will not have~     the ability to view the HII.~      Once patient leaves the ICU the study team will collect information on the remainder of~     patient's hospital course including date of hospital discharge. All collected data will be~     then fully de-identified and released to Philips for analysis.~      This clinical investigation is designed to answer several key questions including:~        1. Are the performance metrics the same when the algorithm operates in the live host as it~          does on retrospective data?~        2. Are there opportunities for improvements in the host implementation; including~          graphical rendering of the HII information and creation of an alert?~        3. Are the predicted workflows which result from the use of the HII clinically acceptable?~        4. Is there a difference in the clinical measures for patients who have HII displayed when~          compared to those who do not?~        5. What is the optimal care process which should be followed based on the presence of the~          indicator?~   "
66783|NCT02183207|"~     Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and~     easy to perform. However, it is limited by its need to be performed in an endoscopy unit.~     E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any~     hospital setting and introduced via nasal approach. Our aim is to prove that PEG by~     introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at~     hospitals and medical facilities without endoscopic units.~   "
66606|NCT02185508|"~     The purpose of this study is to determine the relation among: (1) changes in voltage and~     amplitude of trans-operatory records obtained through the use of Intra-operative~     Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1~     or 2 levels surgical decompression at lumbar spine.~      IONM is the use of real time neurophysiological techniques during spinal surgeries. The~     modalities included in this study are:~        -  Somatosensory evoked potentials (SSEPs).~        -  Trans-cranial electric motor evoked potentials (tceMEPs).~        -  Spontaneous electromyography (EMG).~      Clinical outcome of the patients will be assessed through a careful evaluation of clinical~     data, as well as the application of three outcome scales:~        -  Oswestry Disability Index 2.1a~        -  Visual Analogue Scale for Pain~        -  Patient's Overall Impression of Change~   "
66607|NCT02185495|"~     Imaging procedures including chest X-ray and low-dose computed tomography may be effective~     in lung cancer early detection. Yet it is unknown whether low-dose computed tomography~     combined with computer aided detection （CAD) is more effective than LDCT in screening of~     early lung cancer.~   "
66608|NCT02185482|"~     There is a high prevalence of depression in patients with diabetes mellitus. Depression has~     been shown to be associated with poor self-management (adherence to diet, exercise, checking~     blood glucose levels) levels in patients with diabetes.To determine whether enhancing~     quality physician's care for depression improves both depression and diabetes outcomes in~     patients with depression and diabetes.~   "
66609|NCT02185469|"~     There are multiple ways to treat retinal detachment, the aim of this study is to compare the~     amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to~     vitrectomy.~   "
66610|NCT02185456|"~     Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of~     women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three~     months and 70-80% within a year. Given the paucity of information and data regarding~     pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown.~     Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are~     not available.~      In 2013, the investigators published two manuscripts documenting a new qPCR based approach~     to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of~     lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this~     study are to validate that this metric is a reliable diagnostic of BV, by determining~     sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy~     women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second~     goal is to determine whether empirically determined low LbRC scores (1-2) in BV patients~     after treatment are indicators of recurrence, and whether preemptive action, based on this~     score, with more intensive treatment, delays or eliminates recurrence in these patients.~   "
66611|NCT02185443|"~     This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in~     patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal~     Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of~     extra-hepatic disease or have disease that is planned to be treated with curative intent.~      Therefore, SBRT is being considered as a potentially curative procedure.~   "
66612|NCT02185430|"~     COPD is often associated with the airflow limitation and the pulmonary hyperinflation.~     During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and~     hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary~     hyperinflation would divert pulmonary blood flow and impair arterial oxygenation.~     Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral~     vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The~     investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min~     followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation)~     as bronchodilator in COPD patients when administered during surgery with the one lung~     ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a~     vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a~     vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to~     anesthetic agents in COPD patients during the OLV.~   "
66613|NCT02185417|"~     The purpose of this study is to determine whether chlorthalidone is more effective than~     hydrochlorothiazide at preventing cardiovascular outcomes in Veterans over age 65 with~     hypertension. Both medications are thiazide-type diuretics that have been used for more than~     50 years and are considered first-line treatment for hypertension. Patients currently~     prescribed hydrochlorothiazide will be randomized to either continue taking~     hydrochlorothiazide or to receive chlorthalidone, and followed for major cardiovascular~     events, such as myocardial infarction (MI) and stroke. The study will use a new, efficient~     and less expensive study design termed 'point of care', in which study operations will be~     conducted centrally and patient data will be collected passively through the electronic~     medical record.~   "
66614|NCT02185404|"~     The objective of this research is to test a passive shoe capable of to test the capability~     of a mobile shoe to enhance gait improvements in individuals with asymmetric walking~     patterns. Individuals with central nervous system damage, such as stroke, often have~     irregular walking patterns and have difficulty walking correctly. Recent research has shown~     that using a split-belt treadmill can create after-effects that temporarily correct the~     inefficient walking patterns. However, the corrected walking pattern does not efficiently~     transfer from the treadmill to walking over ground. The Gait Enhancing Mobile Shoe (GEMS)~     may allow a patient to practice walking in many different locations, such as their own home,~     which we hypothesize will result in a more permanent transfer of learned gait patterns. To~     enable long-term use, our proposed shoe design is passive and uses the wearer's natural~     forces exerted while walking to generate the necessary motions.~   "
66615|NCT02185391|"~     Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine~     the risk factors secondary prevention is of great importance. After their residence in~     rehabilitation centers patients often get rid of newly required skills. In addition to that~     parameters like BMI, blood pressure and cholesterol level return to their initial value.~      Using an Audience Response System (ARS) during oral presentations in rehabilitation centers~     should improve the learning effect of patients. Furthermore patients will receive motivating~     telephone calls in the follow-up. These methods should lead to a sustainable improvement of~     learning effects, health care behavior and quality of life.~   "
66616|NCT02185378|"~     One-lung ventilation, even in patients with healthy weight, causes an impairment in~     gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung~     ventilation in obese patients would be improved by applying inverse-ratio ventilation,~     reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the~     restrictive ventilatory effects of obesity, these patients often show a decreased functional~     residual capacity and decreased expiratory reserve volume, leading to an overall decreased~     tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt~     shunting. There are few studies on the one lung ventilation in obese patients about this~     prolonged inspiratory time ventilatory method. We plan to investigate the effect of this~     ventilation method in obese patients during one lung ventilation.~   "
66617|NCT02185365|"~     When arthritis starts it can be noticed first in certain molecules in your joint.~     Proteoglycan is a molecule that is important to cartilage structure, and is lost as~     arthritis develops. Magnetic resonance imaging (MRI) is one of the best ways to image~     cartilage, and an investigational MRI technique that has shown great promise in detecting~     proteoglycan amounts is called T1-rho.~      In this study, patients with hip dysplasia will undergo this investigational MRI in addition~     to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at~     detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while~     the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can~     then be used to look at cartilage damage in the hip without having to have an injection.~   "
66618|NCT02185352|"~     The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction~     BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole~     bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in~     metastatic breast cancer (MBC) patients who have not previously received WBRT.~      In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective~     treatment for brain metastases of breast cancer progressing from WBRT by a multi-center~     phase II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of~     preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that the~     effect of bevacizumab induced tumor vascular normalization takes time to mature.~      The investigators hypothesized that as induction BEEP decreased the size of brain tumors,~     the effectiveness of WBRT would be maximized. The investigators expect this integrated~     approach will do greater benefit to MBC patients with BM, irrespective of subtype.~   "
66619|NCT02185339|"~     The primary objective of the current study is to compare intraoperative respiratory~     mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade~     (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare~     intraoperative hemodynamics and postoperative pulmonary function between the two groups.~   "
66620|NCT02185326|"~     The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI~     cycles in poor responders~   "
66621|NCT02185313|"~     The long-term goal of this research is to advance the investigators knowledge of how the~     cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)~     modulates vestibular information that is forward-ed from the labyrinth and brought to~     perception. While gaze holding is stable also at large angles of gaze eccentricity in~     healthy human subjects, patients with chronic (degenerative) cerebellar disorders are inable~     to stabilize gaze in eccentric positions, resulting in eye drift towards primary~     (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary~     position, a compensatory nystagmus into the opposite direction (called rebound nystagmus)~     can be observed in these patients. Unlike patients with de-generative cerebellar disorders,~     patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with~     acute deficits of gaze holding and verticality perception.~      While a linear relationship between the amount of eye velocity drift and eccentricity of eye~     position has been proposed in healthy human subjects, others suggested non-linear behaviour.~     The strategy of this research is to characterize gaze holding and verticality perception in~     healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic~     degenerative cerebellar disorders and to relate eye movement findings with structural~     imaging of the cerebellum. The investigators will therefore analyze key cerebellar~     structures with regards to loss of volume and relate these imaging findings with the~     participants' ability to hold gaze and es-timate direction of vertical. The investigators~     hypothesize that besides the flocculus other vestibulo-cerebellar structures are involved in~     gaze holding and verticality perception in humans.~   "
66622|NCT02185300|"~     Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada,~     Australia and EU. A dispersible tablet has been developed for pediatric use as an~     alternative to the granule formulation, already in development, and the approved film-coated~     tablet. This is a single-center, randomized, open-label, 5-way crossover study in healthy~     adult subjects. The study will evaluate the relative bioavailability of five dosing~     regimens: 20 mg DTG pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets~     (DTG 20 mg DT) after dispersed in: low mineral content(LMC) water (Treatment B); dispersed~     in CONTREX™ mineral water (Treatment C); dispersed in low mineral content water and consumed~     after standing for 30 minutes (Treatment D) and dispersed in CONTREX mineral water and~     consumed after standing for 30 minutes (Treatment E). Safety evaluations and serial PK~     samples will be collected during each treatment period. A follow-up visit will occur 7-14~     days after the last dose of study drug. CONTREX is a trademark of Nestlé Waters Corporation.~   "
66623|NCT02185287|"~     Aim of the study protocol is to evaluate in a prospective investigation of health statistics~     if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be~     the result of past urinary pediatric dysfunction. The aim is to be able to identify the~     risk conditions which, if treated properly in early childhood, to help avoid debilitating~     problems that manifest themselves as adults and possibly to implement a strategy of~     prevention.~      The choice of this age group is due to the fact that it allows for easier retrieval of data,~     as it is presumed that the concerned can more easily remember their history of pediatric and~     / or have parents still young enough to ask for such information. The problems of urinary~     disorders in childhood era have been the subject of increased attention by pediatricians~     from the end of the 70s, therefore, history taking may be more complete.~      A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore~     our study aim is to investigate an age group that does not appear in the literature to~     supplement these findings, already reported.~      Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult~     Urologists in order to implement a shared strategy for the management of patients with~     problems of impaired bladder function in order to improve the future lower urinary tract~     function.~      Materials and Methods: A self administered questionnaire will be used in accordance with the~     guidelines of the International Children's Continence Society. The questionnaire consists of~     two parts: the first explores the history of urological clinic patient until the age of~     14,in order to evaluate any symptoms reported in a specific category of typical dysfunction~     of childhood; the second part refers to the present together with urological disorders of~     sexual function which, as emerges from the data of the literature may be of relevance~     urological diseases detectors. The data obtained will then be subjected to statistical~     calculations by which will evaluate the significance of the symptoms present in childhood in~     relation to their penetrance in various forms of adult diseases dysfunctional bladder and /~     or sexual abuse, with the prediction of the evolution of the same.~      The questionnaire is anonymous in order to protect privacy. The questions that comprise it~     have been partly extracted from the questionnaire validated by the International Children's~     Society Continent and partly made by the authors of this study on the basis of the~     scientific evidence.~      Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,~     University of Perugia, while the healthy controls will be recruited by submitting a~     questionnaire to the women chosen to sample a healthy population of Graduate Schools found~     in the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.~      The Investigators defined that the statistically significant number of healthy and~     pathological subjects can not be less than 200 units per reference category.~      The time duration of the collection of anamnestic data depend on the ability of the authors~     of this research in finding the subjects to be analyzed.~      There are no conflicts of interest to declare, no drugs or medical equipment will be tested~     .~   "
66632|NCT02185170|"~     The aim of this study is divided in 4 different steps:~        -  the first step has two different purpose: assess the impact of the storage medium of~          fresh prostatic chips on fluorescence signal and adjust the entire chain~          (immunolabelling,counter-stain and imaging),~        -  the second step is the adaptation of immunolabelling protocol on histopathology slides,~          using fresh prostatic tissue,~        -  the third step is to validate the use of:~             1. the medical device created by the FEMTO-ST institute use for the detection of~               fluorescence signal on fresh tissue,~             2. the Light-CT scanner use for tissue structural observation.~        -  the four step is to check the preservation of morphological structure of tissue under~          the effect of laser excitation from the medical device.~   "
66624|NCT02185274|"~     Gender identity disorders (also known as transsexualism) is defined as a condition in which~     a person with apparently normal somatic sexual differentiation is convinced that he or she~     is actually a member of the other sex. Most patients therefore undergo so called cross-sex~     hormone treatment. Treatment protocols follow international consensus statements but vary~     considerably between different centres and countries since no prospective and controlled~     trials are available on this subject and recommendations are mainly based on retrospective~     data analysis and experience of the individual centres. Applying high doses of testosterone~     to biological females and vice versa high doses of estradiol to biological males definitely~     impacts myriads of body functions, from which it has to be assumed that only a minority has~     already been elucidated so far. Especially in male-to-female-transsexuals there seems to be~     an increased risk for the development of mood disorders and cardiometabolic comorbidities.~     In this multi-center observational study we want to investigate, if there is any difference~     with regard to these outcomes, according to the varying standards of cross-sex hormone~     treatment between the different centers. Different outcome measures described below will be~     assessed each time during routine visits at the different centers.~   "
66625|NCT02185261|"~     This study aimed to evaluate the efficacy of interferon α among patients undergone~     unmanipulated blood and marrow transplantation following day 60 post-transplantation who~     were minimal residual disease positive after transplantation.~      Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute~     leukemia and many other hematological malignancies. However, post-transplant relapse can~     occur in some patients, and the prognosis of these patients is usually very poor.The~     persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is~     an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen~     patients with a high risk of relapse to provide timely intervention and prevent~     post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect.~     It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell~     functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients~     with MRD-positive after transplantation.~      The study hypothesis:~      Prevention of relapse using interferon α-2b following hematopoietic stem cell~     transplantation in patients with standard risk acute leukemia can reduce relapse rate.~   "
66626|NCT02185248|"~     The objective of this study was to determine the effectiveness of a novel Wellness Action~     Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing~     follow-through with plans and 3) aiding parents in identifying their child's weight~     category.~   "
66627|NCT02185235|"~     Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse~     (POP), and fecal incontinence—which often occur together.~      Pelvic floor disorders impair multiple aspects of the life quality, including the sexual~     function of women.~      Surgery became the first choice of treatment, however, and not until 1980s was the renewed~     interest in conservative therapies.~      This may be because of higher awareness among women and cost of and morbidity after surgery.~      The conservative treatment included pelvic floor muscle training, electrical stimulation,~     vaginal cones, and biofeedback.~      The outcome was up to 35~70 % improved rate as the literature before. Current guidelines~     recommended conservative management as a first-line therapy. However, there was no~     consistent consensus on this issue due to variations in stimulation parameters、adjuvant~     concurrent modality or duration of treatment course, and insufficient result about large and~     long term follow up of randomized- controlled studies.~      Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the~     efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary~     incontinence, chronic pelvic pain etc.).~      At the aspect of Quality of life, our studies tried to focus on the different domains of~     pelvic disorder and sexual quality by means of validated questionnaire more objectively.~   "
66628|NCT02185222|"~     As recommended allowance of oral vitamine D are unable to ensure the recommended serum~     concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3~     higher than the recommended allowance may slow the cognitive decline of patients with a~     memory complaint.~   "
66629|NCT02185209|"~     The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in~     the treatment of periimplantitis is needed.~   "
66630|NCT02185196|"~     Background:~        -  Burden: Pneumonia is the leading cause of morbidity and mortality in under-five~          children, particularly in developing countries.~        -  Knowledge gap: Although many studies have reported an association between vitamin D~          deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e.~          the impact of vitamin D supplementation in the management of childhood pneumonia.~        -  Relevance: Vitamin D plays an important role in modulating the innate immune response~          against infections. We, therefore, propose to conduct this study to assess the impact~          of vitamin D supplementation, in addition to standard antibiotic and supportive~          therapy, on the outcome of severe childhood pneumonia.~      Hypothesis: The investigators hypothesise that in the management of hospitalized severe~     pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard~     antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may~     thereby shorten duration of severe pneumonia and also reduce the risk of new episode of~     pneumonia.~      Objectives: The objective of the investigators study is to assess the clinical benefit of~     oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive~     therapy, to hospitalised, under-five children with severe pneumonia.~      Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children~     of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically~     diagnosed severe pneumonia will comprise the study population. Eligible children will be~     allotted a sequential study number, which will have been previously assigned to vitamin D or~     placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the~     children will be blinded as to whether vitamin D3 or placebo has been added to their child's~     diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6~     months or older will receive Milk Suji as a complementary food. Vitamin D3 supplementation~     will be given on five consecutive days, from the day of enrolment in addition to standard~     antibiotic and other supportive therapy.~      Outcome measures/variables:~      Primary outcome measure will be time to resolution of severe pneumonia.~      Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in~     drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new~     episode of pneumonia after discharge.~   "
66631|NCT02185183|"~     Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will~     be tested in patients with inflammatory bowel disease.~   "
66653|NCT02184897|"~     Twenty four patients with multiple myeloma will be randomized to either AM group~     (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am~     ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on~     D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with~     pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic~     progenitor cell count. In addition, the yield of stem cell collection between two arms will~     be analyzed.~   "
66633|NCT02185157|"~     The training of a secondary task while walking, whether it is reasoning activities, memory~     or motor tasks, may enhance automation, walking performance, and postural control and, thus,~     minimize the risk of falls influenced by the walking patterns variability. However, the~     literature is scarce regarding the influence of dual-task training on changes in gait~     parameters.~      The purpose of this prospective, blinded randomized controlled trial is to compare the~     short- and long-term effects of dual-task and aerobic training on gait stride variability~     and superior cerebral functions of independent community-dwelling elderly women.~      The participants will be randomly allocated into either experimental or control groups.The~     experimental group will undertake 50 minutes/day of dual-task training, three times/week~     over 12 weeks, totaling 36 sessions, whereas the control group will receive the same doses~     of aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation~     of the interventions, researchers blinded to group allocations will collect the outcome~     measures.The interventions will be delivered by trained physical therapists.~      Primary outcome will include gait stride variability, which will be assessed by a movement~     analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal~     and fast speeds. Secondary outcome measures will include a battery of global and specific~     cognitive function tests.~      The findings of this trial may help better understand whether cognitive-motor interventions~     with older adults, when compared to traditional aerobic training, would result in greater~     improvements in gait under dual-task conditions and lead to improvements in cognitive tasks.~     Furthermore, the findings could potentially bring important insights regarding the impacts~     of improvements in walking abilities and cognition.~   "
66634|NCT02185144|"~     The PATH for Triples (PFT) Study is an effectiveness trial comparing a nurse health~     navigator (NHN) model for HIV+ persons with severe mental illness and substance abuse (i.e.,~     triply diagnosed) with Treatment as Usual (TAU). The team completed a Phase II trial of the~     nurse health navigator model for HIV+ persons with severe mental illness that showed the~     intervention was effective. The investigators are now testing the intervention in a real~     world setting with patients recruited from psychiatric and substance abuse inpatient units~     in Philadelphia using a longitudinal design. The intervention is set up as a cascade where~     non-adherent patients receive additional visits from the study nurses. It is hypothesized~     that patients assigned to the NHN will have better medication compliance, reduced viral~     loads and improved CD4 counts compared to patients assigned to TAU. It is also hypothesized~     that the PFT intervention group will be more cost effective compared to TAU. This group of~     triply diagnosed patients are at very high risk of negative health outcomes and secondary~     transmission of HIV and, therefore, the study is of high public health significance.~   "
66635|NCT02185131|"~     Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique~     structure and mechanism of action. Recent study results suggest that mirtazapine may be more~     effective and faster acting than other antidepressants. Levels of alcohol use have been~     shown to be associated with levels of depressive symptoms among comorbid populations. Our~     own recent open label pilot study suggested robust within-group efficacy for mirtazapine for~     decreasing both the drinking and the depressive symptoms of persons with co-occurring~     alcohol dependence/major depressive disorder (AD/MDD). However, no placebo control group was~     employed in that study, so between-group efficacy versus placebo could not be assessed. The~     current grant submission proposes to conduct a first double-blind, placebo-controlled study~     to evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and~     depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed~     double-blind pilot trial are promising, then the effect sizes found in this proposed study~     will be used to help design an adequately-powered R01 treatment trial to definitively test~     the efficacy of mirtazapine in this comorbid population.~   "
66636|NCT02185118|"~     Sepsis is a major cause of death in intensive care units. Despite the investigators improved~     understanding, which has reduced the risk of dying with sepsis, the number of people who die~     each year continues to increase due to an overall increase in the number of cases.In our~     previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar~     concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line~     against in-vitro sepsis induced by lipopolysaccharide (LPS).~      In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC~     isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis~     induced by LPS or plasma from septic patients.~   "
66637|NCT02185105|"~     The study hypothesis is there is no difference in the clinical performance between the test~     and control lenses, in particular in lens stability, toric mislocation, comfort ratings and~     anterior segment ocular health findings.~   "
66638|NCT02185092|"~     The purpose of the study is to examine the hypothesis test that probiotics will reduce the~     frequency of exacerbation in patients with COPD.~   "
66639|NCT02185079|"~     Procedural skills are an important determinant of clinical outcomes for certain patient~     groups. Training for procedural skills in the medical profession is still largely based on~     an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do~     so by practicing on patients under direct supervision by seniors (consultants or senior~     registrars/residents). Learning a complex and high risk procedural skill on patients is not~     ideal.~      As medical training moves from apprentice based to competency based training along and as~     for the number of clinical learning opportunities for trainees is less, it is necessary to~     develop a comprehensive training programme which enables effective and efficient learning~     without compromising on patient safety. Metrics-based performance based progression has~     shown to improve clinical performance not only in novices but also in experts.~      We envisage a standard methodology which could address the deficiencies in procedural~     training currently. This would entail development and validation of a set of metrics for a~     particular procedure, evaluation of a proficiency based progression training programme based~     on those metrics to and demonstration of improved clinical performance and clinical outcome~     associated with that programme. Although elements of this end -end approach have been~     demonstrated previously for various procedures, we propose to apply this methodology in its~     entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To~     date we have developed and are validating a set of metrics for this procedure. Proficiency~     based training leading to better procedural skills leading to better patient outcomes has~     not been studied so far. Epidural analgesia during labor lends itself as an excellent model~     for evaluating the whole process. It has a specific procedural skill which is closely linked~     to patient outcome which is measurable and occurs in finite time interval.~      The hypothesis of the study is that in novice anaesthetic trainees, training with metrics~     based performance based progression in addition to improving the clinical performance will~     also reduce the failure rates of labor epidural analgesia to 5% when compared to 25%~     achieved by conventional training.~   "
66640|NCT02185066|"~     This study is designed to evaluate safety and pharmacokinetic properties of the two~     treatments, the administration of CJ-30056 and the co-administration of atorvastatin and~     metformin XR, in healthy volunteers.~   "
66641|NCT02185053|"~     This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple~     Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with~     Alzheimer's Disease Type Dementia.~   "
66642|NCT02185040|"~     The purpose of this study is to determine whether CC-220 is effective for the treatment of~     skin, joint and serological manifestations of systemic lupus erythematosus.~   "
66643|NCT02185027|"~     The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran~     (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises~     novel questions among clinicians confronted with the emergency management of patients~     treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will~     eventually win a significant market share in the indications secondary prevention of venous~     thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial~     fibrillation, due to their net clinical benefit and their practicality of use compared with~     vitamin K antagonists (VKAs).~      However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about~     half compared with VKAs, the risk remains significant; furthermore, in clinical trials,~     these drugs had little or no effect on reducing the incidence of major extracranial~     bleeding. In everyday practice, where the indication could be expanded to unselected~     populations and due to a potential for misuse, it is likely that the incidence of bleeding~     complications will be higher than that reported in clinical trials. Indeed, the numerous~     alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear~     witness to this, and should serve as a reminder that these anticoagulants have a real~     potential for bleeding complications and, in the absence of an antidote, there is no~     validated management strategy.~      Furthermore, as these drugs can be prescribed for months or years, patients may eventually~     be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive~     procedures, trauma, etc. Analysis of data from the RE-LY trial (dabigatran versus warfarin~     in patients with atrial fibrillation) showed that during the two years of follow-up,~     approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker~     insertion to major surgery. Thus, a large proportion of patients treated with NOACs are~     concerned by this issue.~      In anticipation of a gradually increasing influx of patients in a critical situation (active~     bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to~     define the conduct to adopt based on the experience gained from the earliest cases. This is~     the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French~     Working Group on Perioperative Hemostasis).~      For the moment, then, the management recommendations derive from expert opinions based on~     pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by~     various nonspecific procoagulants (non-activated or activated prothrombin complex~     concentrates, recombinant factor VIIa). These procoagulants are currently used in an~     empirical manner to control bleeding, with as many successes as failures reported in the~     literature, and their benefit-risk ratio in these patients is therefore uncertain.~   "
66644|NCT02185014|"~     This study will evaluate the long term efficacy, safety, and tolerability of repeated~     administration of adalimumab in subjects with Crohn's disease.~   "
66645|NCT02185001|"~     Background: The forces involved in a patella dislocation event can cause significant~     collateral damage involving the articular cartilage of the patella femoral joint. As a~     result, prevention of recurrent patella dislocation and the associated disability and~     morbidity has generated significant interest in the orthopedic community. Historically,~     nonoperative treatment for first time patella dislocation has been problematic due to high~     redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization,~     followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both~     soft tissue and boney realignment operations, have also had mixed results, including low~     success rates, associated complications, and variable rates of return to functional activity~     (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial~     Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.~      Methods/Design: This study is designed as a two arm randomized prospective trial.~     Approximately fifty subjects will be randomly assigned to either a surgical or non-operative~     arm by means of a computer randomized allocation program. All subjects will have X-Ray~     Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to~     determine if any excluding conditions exist. Subjects randomized to the surgical group will~     have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that~     has agreed to follow our protocol. Subjects randomized to the nonoperative group will~     receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with~     physical therapy for approximately 12 weeks. Physical therapy will progress through five~     phases with the goal of gait normalization, full range of motion and return to sport. Both~     arms will be given outcome questionnaires and physical activity assessments before~     treatment, and at one, three, six, twelve, and twenty four month intervals.~      Discussion: This prospective randomized trial will investigate the results of direct repair~     of the medial patellofemoral ligament and conservative treatment by applying subjective~     outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration~     or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and~     six months post trauma. Any reported recurrent dislocation or subluxation event will be~     documented during recovery. All subjects will receive merchant x-ray views at 3 months with~     manual lateral translation of the patella.~   "
66646|NCT02184988|"~     The purpose of this study is to demonstrate the safety of multiple doses of DWP-450~     (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe~     glabellar lines in adult subjects.~   "
66647|NCT02184975|"~     The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined~     according to the colposcopic evaluation of the patient. In case colposcopy findings are~     satisfactory (visible squamocolumnar junction), both ablative and excisional methods are~     adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the~     cold knife conization surgical technique to reduce blood loss. Some authors recommend that~     these branches should be ligated, but it remains unclear whether these sutures are actually~     effective in reducing bleeding.This study compared blood loss during cold knife conization~     of the cervix with and without lateral hemostatic sutures.~   "
66648|NCT02184962|"~     The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their~     relationship in gingival crevicular fluid of post-menopausal women with~     osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect~     that the use of bisphosphonates in periodontal disease.~      Study hypothesis:~      The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease~     affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring~     osteoclastogenesis processes ~   "
66649|NCT02184949|"~     The relationship between annual procedural volume and patient outcome remains a debated~     issue in the field of interventional medicine. An under-explored issue in a UK context is~     whether or not such a relationship exists for percutaneous coronary interventions (PCI). In~     recent years, this procedure has replaced thrombolysis as the standard intervention method~     used in UK hospitals for widening patients' obstructed coronary arteries. However, the~     actual number of such procedures currently undertaken annually remains variable across~     hospitals where these interventions are performed. The UK's National Institute for Health~     and Care Excellence has consequently called for research into whether such differences in~     volume play any role in patient outcome for this particular procedure. The current study is~     intended to address that research need, and will do so by looking at whether the annual~     number of PCI procedures undertaken by individual hospitals is predictive of patient~     mortality post-procedure.~   "
66650|NCT02184936|"~     Treatment of acute ischemic stroke is aimed at salvaging viable but ischemic brain by~     opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time~     saved while making critical decisions correctly is vital in acute ischemic stroke~     management. Conventional angiography is invasive, resource intensive and not feasible as a~     fast diagnostic tool. Perfusion CT and MRI are both susceptible to patient motion, need~     trained personnel to process and take at least 10-30 min to acquire and interpret. The~     investigators have developed a new imaging selection tool, multi-phase CT Angiography (CTA),~     which generates multiple time resolved images of backfilling arteries beyond a blocked~     artery filled by collaterals.~      The investigators seek to determine: i) if patients with acute ischemic stroke will have a~     differential clinical response to early recanalization based on collateral status assessed~     on multi-phase CTA, ii) if the extent to which collateral assessment on multi-phase CTA~     resembles perfusion CT in predicting which patients will have good clinical outcome with~     early recanalization, iii) Identify determinants of variability in native collateral status~     in patients with acute ischemic stroke.~      The investigators hypothesize that patients with good and intermediate collaterals on~     multi-phase CTA achieve good clinical outcome with early recanalization (within 4 hours of~     baseline imaging); patients with poor collaterals do not do well even with early~     recanalization.~      Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive~     patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with~     evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other~     comprehensive stroke centers will recruit patients into this study. Primary outcome is~     defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours~     or an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a)~     90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic~     improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct~     volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II~     criteria) at 24 hrs.~      Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and~     thrombolysis decisions in the setting of acute ischemic stroke which is widely available,~     and can quickly and reliably detect salvageable brain.~   "
66651|NCT02184923|"~     The long-term goal of this research is to advance our knowledge of how information from the~     labyrinth is brought to perception and how adaptation to vestibular imbalance influences~     spatial orientation. In healthy human subjects verticality perception is accurate while~     upright.The strategy of this research is to quantify changes in verticality perception after~     unilateral lesions along the central graviceptive pathways and to assess the frequency and~     pattern of abnormal verticality perception in patients with acute stroke (ischemic or~     hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality~     perception by use of a mobile device assessing the subjective visual vertical (SVV) during~     the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those~     patients with defects. Early detection of deficits in verticality perception may help to~     initiate balance physiotherapy early.~   "
66652|NCT02184910|"~     It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which~     leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to~     assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for~     atrophic gastritis and whether gastric atrophy based on the PG test would be improved after~     H. pylori eradication.~   "
66654|NCT02184884|"~     The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,~     maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in~     platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A~     study reported that the TEG® can be used as routine monitoring of the variability in ADP~     receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping~     assay, we could find out the perioperative clopidogrel responsiveness of the patients with~     ACS undergoing OPCAB.~      The purpose of this study is to determine whether the rate of the major adverse cardiac~     events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in~     the patients with high degree of clopidogrel resistance, who are scheduled to undergo the~     OPCAB due to ACS.~   "
66655|NCT02184871|"~     The aim of the present study is to perform a comprehensive molecular characterization of~     intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk~     factors (such as asbestos) for this malignancy, in order to identify possible molecular~     signatures associated to such different risk factors.~   "
66656|NCT02184858|"~     This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and~     safety of lisinopril in children 1-18y whose parents grant permission to participate. This~     dose titration study is being conducted to support the statement that personalized titration~     of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient~     response.~   "
66657|NCT02184845|"~     Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with~     single crowns in the maxillary lateral incisor area or mandibular central or lateral incisor~     area.~   "
66658|NCT02184832|"~     This study will examine the influence of dietary intake of tryptophan on response to~     metformin. The investigators hypothesize that dietary tryptophan alteration will influence~     metformin response.~   "
66659|NCT02184819|"~     The investigators want to test the hypothesis that an infusion of levosimendan started prior~     to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients~     with poor LV function (EF 40% or less).~   "
66660|NCT02184806|"~     Ovarian tissue cryopreservation is a new technique for female fertility preservation. One~     way to restore fertility is autotransplantation of ovarian tissue.~      The principal purpose of this study will be to evaluate the efficiency and safety of this~     procedure.~   "
66661|NCT02184793|"~     Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head~     of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in~     those patients. However, such a bed inclination frame is still difficult to maintain in~     day-to-day care.~      The aim of the study is to evaluate the impact of an electronic monitoring device on the~     proportion of time spent per day in semi-recumbent position, as defined by a head of bed~     inclination between 40° and 50°, in mechanically-ventilated patients.~   "
66662|NCT02184780|"~     This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia~     on neurocognitive outcomes in early childhood by analyzing neurocognitive data already~     obtained from the local prospective observational cohort study: Growing up in Singapore~     Towards Healthy Outcomes (GUSTO).~      We hypothesize that:~        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer~          neurocognitive outcomes at 6, 18, 24 and 36 months.~        2. Maternal anxiety and depression during the antenatal and post-partum period is~          associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.~   "
66663|NCT02184767|"~     This study is to assess the pharmacokinetics of loxapine and will be using plasma~     concentration data obtained over 48 hours after administration of the study drug~   "
66664|NCT02184754|"~     Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope~     navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in~     which scope navigation is particularly important. The MEI will be compared with x-ray which~     is still the current gold standard for scope navigation in small bowel enteroscopy.~   "
66665|NCT02184741|"~     To estimate the safety and efficacy of intravenous immunoglobulin therapy using GB-0998 in~     women with four or more miscarriages by carrying out randomized, placebo-controlled,~     double-blinded study．~   "
66666|NCT02184728|"~     An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for~     PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread~     use of capnometry on-site at emergency and trauma fields. So, portable device can be used~     usefully.~   "
66667|NCT02184715|"~     The purpose of this study is to investigate the effects of virtual reality system on~     children with developmental delays.~   "
66668|NCT02184702|"~     Intubation is needed in general anesthesia and appropriate cuff pressure is important to~     avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some~     amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure~     cuff pressure during shoulder arthroscope.~   "
66669|NCT02184689|"~     The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole~     (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping~     sickness in children at least 6 years old and over 20 kg bodyweight.~   "
66670|NCT02184676|"~     The purpose of this study is to determine whether early immunological markers (activation of~     autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies~     in children born from type 1 diabetic parents.~   "
66671|NCT02184663|"~     Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for~     patients with unresectable pancreatic cancer.~      Thereby, it is proposed to conduct an open trial to assess effects of the APA program in~     such population~   "
66672|NCT02184650|"~     The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks,~     the association between:~        -  the quantity of mother's milk and duration and breastfeeding~        -  the intake of polyunsaturated fatty acids and iron during hospitalizations~   "
66678|NCT02184572|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     trivalent MMR (Priorix®), comparing it to Merck's MMR vaccine (M-M-R®II), which is approved~     for use in the US in healthy children 12 to 15 months of age.~   "
66673|NCT02184637|"~     This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in~     healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK)~     evidence to support the safe usage of Tafenoquine (TQ) in studies and markets where the~     Artemisinin-based Combination Therapies (ACTs) are the standard of care for patients with~     Plasmodium vivax malaria (i.e., co administration with TQ). The objective of this study is~     to assess the pharmacokinetics, safety and tolerability of TQ when co-administered with the~     chosen ACTs (AL and DHA + PQP), administered concomitantly in healthy subjects.~     Specifically, the study will evaluate whether there are drug-drug interactions between TQ~     and each of the ACTs and if these interactions are considered to be clinically significant.~     The co-primary objectives of this study are to characterize both the effects of a 300~     milligram (mg) single dose of TQ on the pharmacokinetics; changes in (area under the~     concentration-time curve from 0 to time t) AUC (0-t), AUC (0-infinity), and maximum observed~     concentration (Cmax) of each of the two Artemisinin-based Combination Therapies (ACT)~     according to their prescribed dose when co-administered as well as the effects of the ACTs~     on the PK of TQ.~      A total of 120 subjects (24 subjects in each of 5 cohorts) are planned to be enrolled in~     order to ensure a target sample size of at least 22 subjects completing the study per~     cohort. All subjects will arrive in the unit at least 24 hours prior to dosing and be~     discharged after 72-hour post first dose assessments have been completed. Subjects will~     return for outpatient visits on Days 7, 14, 21, 28, and 56 after first dose.~   "
66674|NCT02184624|"~     This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.~     The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)~     via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study~     they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the~     other inhaler devices that will be used in this study will be included. Furthermore,~     subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all~     other inhaler devices that requires a capsule. The study will be conducted in the UK and the~     Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600)~     with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible~     subjects will be allocated to one of the sub-studies depending on their experience of using~     the other inhaler (i.e., depending on which other inhaler they are naïve to).~      This study is designed to assess the proportion of COPD subjects making critical and overall~     (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other~     commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI~     and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and~     preference between the ELLIPTA inhaler and the other commercially available inhaler devices.~      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.~     TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of~     Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis~     AG.~   "
66675|NCT02184611|"~     Studies to date provides substantial evidence for the effectiveness for UMEC 62.5 microgram~     (mcg) as a long term maintenance therapy for the treatment of COPD; this study further~     evaluates the efficacy and safety of UMEC 62.5 mcg administered once-daily (OD) for 24 weeks~     via a NDPI compared with placebo in Asian subjects with COPD. Over approximate 27 weeks of~     entire study duration, 10 study clinic visits will be conducted on an outpatient basis.~     Pre-screening visit will be conducted for the informed consent form, review demography, COPD~     history and COPD concomitant medications. Subjects meeting the eligibility criteria at~     screening will complete a 7 to 14 day Run-in period and will be provided with~     albuterol/salbutamol as rescue medication on an as-needed basis. Further, subjects will be~     randomized to the UMEC 62.5 mcg or matching placebo in a 1:2 ratio for 24 week treatment~     period. A follow up for adverse event assessment will be scheduled approximately 7 days~     after the treatment period or the Early Withdrawal Visit.~   "
66676|NCT02184598|"~     Purpose: This project assess the effectiveness of a cognitive training as an add-on~     intervention to drug treatment in children and adolescents diagnosed with~     Attention-Deficit/Hyperactivity Disorder (ADHD) compared to a placebo training. The~     cognitive training consists of 6 computerized games that are based on principles of~     neuroplastic change.~      ADHD: current treatment - International clinical guidelines indicate that pharmacological~     interventions in particular stimulants are the first-line treatment for ADHD. However, about~     30% of children affected by the disorder do not respond to medication alone, exhibit partial~     response or can not tolerate the adverse effects. In addition there is a group of parents~     who do not accept the use of medication for the treatment of ADHD in their children. In~     recent years cognitive training has received considerable attention as a treatment to ADHD.~     The evidence base for cognitive training programs are still forming with few randomized~     placebo-controlled studies. However, this approach seems to be effective either as a~     treatment for ADHD - and others cognitive disorders in childhood - or as a tool to enhance~     cognitive ability and school performance in children and adults. No previous study has~     evaluated this cognitive intervention in a clinical trial with placebo-controlled~     intervention and as an adjunctive treatment to medication. Additionally, the investigators~     will assess brain changes associated with this intervention using neuroimaging (fMRI).~   "
66677|NCT02184585|"~     This study will be an open-label, randomized, single dose, three way crossover study in~     healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of~     two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin~     hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg) relative to co-administration of dutasteride~     0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in both the fed and fasted~     states. Approximately 84 healthy adult male subjects will be enrolled into the study and~     split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete~     each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment~     periods and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA,~     CAB, CBA) wherein A= FDC1: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), B= FDC2:~     Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), C= Co-administration of commercial~     formulations of dutasteride(0.5mg) and tamsulosin HCl (0.2mg). Each treatment period will be~     separated by a minimum 28 day washout period. Blood samples for pharmacokinetic analysis~     will be taken at regular intervals after dosing. Safety will be assessed by measurement of~     blood pressure, heart rate and review of adverse events.~   "
66679|NCT02184559|"~     The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia~     and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention,~     respiratory depression ...). In the case of caesarean sections, the quality of analgesia~     allows one hand to improve the mother-child relationship and the quality of breastfeeding,~     the other to reduce the risk of postpartum depression and chronic pain . Two methods of~     administration of local anesthetics have been proven effective for analgesia of the~     abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and~     infiltration of the scar continues operating. The TAP block was performed under ultrasound~     guidance by the anesthesiologist after the intervention in a single injection of local~     anesthetic in the abdominal wall and has a period of limited and variable. The infiltration~     continues catheter is placed by the surgeon before closing the wound and allows the infusion~     of local anesthetics for 48 hours.~      The purpose of this study was to compare morphine consumption between both techniques, and~     the quality of analgesia and side effects of morphine~   "
66680|NCT02184546|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains~     components with regenerative properties, including stem cells that may be capable of~     ameliorating specific disease conditions. This study is designed to evaluate quality of life~     changes in individuals with PD for up to 12 months following SVF treatment.~   "
66681|NCT02184533|"~     The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium~     selenite when administered in combination with radiation therapy to subjects with metastatic~     cancer based on safety and tolerability.~   "
66682|NCT02184520|"~     This postmarket surveillance study is being conducted to evaluate the TRANSITION~     Stabilization System as an adjunct to fusion in the treatment of acute or chronic~     instabilities or deformities of the thoracic, lumbar and sacral spine. The study will~     involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION~     Stabilization System. The data from this postmarket surveillance study will be provided to~     FDA in accordance with the 522 order.~   "
66683|NCT02184507|"~     The present study aimed to evaluate the effect of a combination of insulin resistance~     reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood~     glucose and oxidative stress regulation.~   "
66684|NCT02184494|"~     Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's~     Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of~     disorder-related fatigue, however, it is unknown whether PD or MS patients experience~     compromised blood lactate responses to an acute bout of exercise, subjecting them to~     exercise-related fatigue. These populations may experience higher energy expenditure at rest~     due to increased rigidity, however, limited data exists investigating resting energy~     expenditure in these populations.~      Researchers hypothesize that PD and MS patients will display higher resting energy~     expenditure than healthy age-matched controls, and that level of energy expenditure will~     correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels~     of lactate will not be different between PD/MS and control groups, but post-exercise blood~     lactate levels will be significantly higher in the PD/MS groups.~   "
66685|NCT02184481|"~     Depression is associated with impairments in executive functions, including working memory~     (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM~     impairments depressed individuals have difficulties inhibiting and shifting from irrelevant~     (negative) information and updating goal relevant information. This study explored whether~     training WM decreases these impairments and reduces clinical symptoms of depression, anxiety~     and rumination. Sixty-one students with an elevated score on the BDI-II, representing a~     dysphoric mood state, executed a working memory training (n = 34) or placebo training (n =~     27). Before and after training their depression, anxiety, rumination and working memory were~     assessed. Furthermore, they executed a working memory task while their pupil dilation was~     measured to assess their fatigue. Moreover, the investigators compared the dysphoric~     students with a healthy student population on all measures.~   "
66686|NCT02184468|"~     The purpose of this study is to determine if dual dispatch of ambulance, fire fighters~     and/or police in out-of-hospital cardiac arrest (OHCA), can reduce the time to~     cardiopulmonary resuscitation (CPR) and defibrillation, thus increasing survival.~   "
66687|NCT02184455|"~     The purpose of this clinical trial is to perform a limited pilot study to determine the~     safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers~     (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment~     will result in positive healing outcomes with no significant adverse effects.~   "
66688|NCT02184442|"~     The purpose of this post approval study is to determine the safety, effectiveness and~     learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients~     and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable~     patients with Severe Symptomatic Native Aortic Stenosis via all access sites.~   "
66689|NCT02184429|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in~     healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of~     food on PF-06669571 plasma concentrations will be be evaluated after a single dose of~     PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days~   "
66690|NCT02184416|"~     This is an international, multi-centre, prospective (partly retrospective), observational~     study to evaluate treatment patterns and clinical outcomes in patients with advanced or~     metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line~     post sunitinib. The study is designed to enroll approximately 750 patients over the course~     of an enrollment period of approximately 36 months.~   "
66749|NCT02183649|"~     The primary objective of this trial was to investigate the potential effects of~     pentoxyverine on the ECGs of healthy subjects. A secondary objective was the exploration of~     safety and tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for~     the explanation of ECG effects.~   "
66750|NCT02183636|"~     Determination of the relative bioavailability of 2 different formulations of a 5 mg~     linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5~     and formulation C8, compared with the mono-components linagliptin and pioglitazone~     administered together~   "
66691|NCT02184403|"~     Laryngeal cancer is common in the Taiwanese populations. Before early 80's, open~     laryngectomy was the suggested treatment modality for laryngeal cancer. Patients of~     laryngectomy lost speech and should communicate by using prosthesis. So after 90's, medical~     organ preservation by chemoradiation therapy took the place of operation.~      Unfortunately, from the recent review, five-year survival rate was decreasing and is even~     lower than that reported 10 years ago. In 1983-1985 it was 68.1% but decreased to 64.7% in~     1992-1999. It is the only cancer type of decreasing survival in 24 index cancers.~      Laser resection of laryngeal tumor was first reported by Jako and Strong and widely used in~     the Europe. Dr Steiner and his colleagues developed a non-en block resection technique made~     microscopic resection more easily and would not be limited by tumor location or size so~     much. The investigators used transoral microscopic laser (TLM) in early glottic cancer and~     reported five-year overall survival as 97%. TLM five-year disease control rate was reported~     as 85%. There are some reports about TLM in advanced stage laryngeal cancer and overall~     5-year survival rate can be achieved as high as 55%. Present project is planning to develop~     a comprehensive organ preservation protocol based on microinvasive TLM as primary treatment~     modality for early glottic cancer without neck or distant metastasis. The objects of the~     project are as followed.~        1. Long term outcomes by performing the treatment protocol. The outcome measurements~          include local control rate, overall and disease specific survival, larynx preservation~          rate.~        2. The difference between surgical samples and pretreatment imaging examination.~        3. The role of adjuvant therapy.~        4. Management and follow-up in neck metastasis.~        5. Searching for risk factors and predictor factors.~        6. Adequate salvage treatments in local or regional recurrence.~        7. Realizing failure patterns and appropriate follow-up protocol according to it.~   "
66692|NCT02184390|"~     This study will evaluate the efficacy and user satisfaction with a web-based interactive~     tutorial for caregivers of young children with autism designed to a) teach parents how to~     promote their child's development in the core deficit areas, b) help parents understand and~     improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress~     through more effective interactions. It emphasizes everyday situations as opportunities for~     learning, including common home routines and contains videotaped illustrations of parents~     using the techniques taught in the home environment.~   "
66693|NCT02184377|"~     Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch,~     Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same~     segmental context carries different meanings depending on the tone. The function deficit of~     cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN),~     would impair the speech tone adjustment. The defect in tone adjustment may interfere with~     the communication function in Mandarin Chinese speaker more than other language users. This~     may explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN~     injury had worse outcomes than those with sole recurrent laryngeal nerve paralysis. The~     neuromuscular control of laryngeal muscle can be evaluated by laryngeal electromyography~     (LEMG). The investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous~     research to measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid~     (TA-LCA) adductor complex. However, the task to measure the CT muscle function by Q-LEMG has~     not been developed yet. It is of thus of utmost interest to develop a standardized task to~     measure the neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking~     patients with UVFP, the lexical tone influence from CT muscle can be discovered by the~     technique. The investigators also want to measure the lexical tone correction by~     conventional laryngoplasty and its influence in CT muscle activity. The data of lexical tone~     and its correlation with CT contractile activity is important in attempting pitch adjust~     artificial electrolarynx.~   "
66694|NCT02184364|"~     To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and~     tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract~     corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative~     and mental complaints~   "
66695|NCT02184351|"~     The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole~     troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where~     this condition has been diagnosed by clinical examination and confirmed by fungal culture.~   "
66696|NCT02184338|"~     Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising~     oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in~     healthy male subjects~   "
66697|NCT02184325|"~     Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets,~     in children of 6 to 14 years, comparing a given formula with an improved one with reduced~     mineral content (qualitatively equivalent to the first one) and a comparator product.~   "
66698|NCT02184312|"~     Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily)~     and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to~     estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE®~     tablet as well as to 400 mg Nevirapine extended release tablet~   "
66699|NCT02184299|"~     Study to determine the incidence of rash between the group receiving nevirapine without~     prednisone and the group receiving nevirapine with prednisone~   "
66700|NCT02184286|"~     The objectives of this study are to determine the effects of nevirapine on the steady-state~     pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the~     steady-state pharmacokinetics of nevirapine. This study will also evaluate the~     pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical~     controls treated with nevirapine but without saquinavir-sgc.~   "
66701|NCT02184273|"~     Study to assess the analgesic efficacy in the prevention of postoperative pain in children~     undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of~     Metamizol in this group of patients.~   "
66702|NCT02184260|"~     Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy~     in the acute phase of ischemic stroke.~   "
66703|NCT02184247|"~     Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release~     theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg~     theophylline anhydrous (sustained-release product) by comparing the rate and extent of~     absorption of theophylline based on both single and multiple-dose profiles.~   "
66704|NCT02184234|"~     Main objective: Safety and tolerability of Antistax® film coated tablets~      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of~     chronic venous insufficiency~   "
66751|NCT02183623|"~     Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin~     and simvastatin acid with and without concomitant administration of BI 1356 BS~   "
66705|NCT02184221|"~     Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in~     major depressive disorder, but the effectiveness is not clear due to stimulated region,~     frequency and intensity of magnet field. Standard TMS techniques only can stimulate~     superficial cortical areas as the electric field decreases rapidly as a function of tissue~     depth，while depression is also interconnected with deeper neuronal regions. Deep-brain~     magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.~     Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have~     particular relevance to the response to antidepressants, and reduction of alpha frequency~     (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency~     and low-field magnetic stimulation could improve depressive symptoms.~      The objective of this study is to compare the effectiveness of the two different parameters~     of DMS in the treatment of major depressive disorder. The changes of brain derived~     neurotropic factor (BDNF) are also investigated to make a relevant analysis of the~     improvement of depressive symptoms.~   "
66706|NCT02184208|"~     Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic~     monitoring are under-utilized when translating research into decision support. Current~     medical informatic capabilities can be leveraged to calculate trends in measured parameters~     to initiate a paradigm shift in critical care from reaction-based treatment to proactive and~     plausibly preventative care. Therefore, the purpose of this study is to develop baseline~     understanding of our practice and how data collection utilizing a newly implemented system~     called T3. We would like to retrospectively review mechanically ventilated patients in which~     we have collected continuous data to test a newly developed analytic platform. Additionally~     we would like to compare these results to our standards of practice established by clinical~     practice guidelines.~   "
66707|NCT02184195|"~     A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance~     Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose~     Disease Has Not Progressed on First Line Platinum Based Chemotherapy~   "
66708|NCT02184182|"~     One of the limiting factors in the execution of a liver resection, in particular an extended~     liver resection, it's represented by the future remnant liver (FRL) after hepatic surgery.~     In cases of normal organ function an FRL of 25% is considered sufficient. In case of~     impaired hepatic function or a history of chemotherapy, it is considered safe if at least of~     40%.~      Many strategies have been developed and proposed to increase the resectability in patients~     undergoing major liver resections.~      One of these is a new two-stage technique proposed recently by a group of German surgeons.~     This approach consists in the ligation of the right portal vein associated with resection of~     the liver along the falciform ligament (step 1). Step 2, after a period of 9 days (median -~     5-25 days), after a volumetric CT to ensure an adeguate hypertrophy of the left lateral lobe~     due to the combination of right portal occlusion and segment 4 devascularization, the~     patient undergo a right trisectionectomy. The hypertrophy of the left lateral lobe is shown~     to be of 74%, higher than any other techniques of ligation or portal embolizatiol proposed~     in the literature.~      On the basis of the clinical experiences reported the investigators designed a new protocol~     of two-stage hepatic resection for the treatment of primary or secondary tumors of the right~     lobe. Step1: laparoscopic radio frequency / microwave ablation of the future transection~     plane between segment 4 and left lateral lobe and surgical ligation or embolization of the~     right portal vein. The ablation has the purpose to devascularize the segment 4 and has the~     same significance of the resection of the liver along the falciform ligament described by~     the Regensburg group.~      Step2: After a period of time of 9 ± 2 days, following a volumetric CT showing an adequate~     liver volume gain (ratio FRL / patient body weight> 0.5), the patient undergo the~     second-stage surgery: laparoscopic/ laparotomic right trisectionectomy.~   "
66709|NCT02184169|"~     The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn~     infants recovering from congenital heart surgery. Currently, we utilize important but~     unsophisticated measures, such as vital signs and lactate measurements, to monitor these~     patients. Although they are useful in categorizing patients as well or unwell, these signs~     currently lack the power quantify a patient's risk for cardiac arrest. More to the point,~     they are mostly indirect measures of what we really are assessing, which is tissue oxygen~     delivery.~      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a~     baby consumes every minute. Historically, these values are more commonly used in combination~     with other measures to assess nutritional and metabolism status. In critically ill patients,~     however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen~     their circulation delivers. This may represent a critical relationship, which has been~     previously described, but not exploited for the purpose of identifying patients with~     critically low oxygen delivery.~      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be~     safely and precisely measured continuously in newborns undergoing one of two common~     congenital heart surgeries, (2) to determine whether postoperative circulatory failure is~     associated with a precedent change in oxygen consumption, and (3) to determine whether the~     addition of the oxygen-based measurements (including oxygen consumption and venous oxygen~     saturations) to standardly measured parameters will add power in predicting which patients~     will experience postoperative circulatory failure.~      If successful, this study may improve our capacity to non-invasively and continuously~     monitor patients following the highest risk congenital heart surgeries, and in the future,to~     create an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may~     permit providers to intervene on these patients earlier, improving the morbidity and~     mortality associated with congenital heart disease.~   "
66710|NCT02184156|"~     In this Phase I/Phase II clinical trial, 7 eligible patients with OA of the knee will~     receive Ampion™ 4 mL administered as three IA injections, 2 weeks apart. In the absence of~     serious drug-related AEs of unanticipated drug-related AEs, enrollment will be initiated in~     Phase II of the study.~      In Phase II, a total of 30 eligible patients with OA knee pain will be randomized 1:1 to~     receive either the active drug (Ampion™ 4 mL) or placebo as three IA injections, 2 weeks~     apart.~   "
66711|NCT02184143|"~     The overall objective of this study is to conduct a two-group randomized control trial (RCT)~     to compare which of two treatments provided by telephone - a cognitive-behavioral based~     physical therapy (CBPT) program focusing on self-management strategies or an education~     program about postoperative recovery - are more effective for improving patient-centered~     outcomes in older adults recovering from lumbar spine surgery for degenerative conditions.~     Our central hypothesis is that the CBPT intervention focusing on self-management will~     decrease pain and disability and improve general health, physical activity and physical~     function in community-dwelling adults undergoing spine surgery, through reductions in fear~     of movement and increases in pain self-efficacy.~   "
66752|NCT02183610|"~     To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and~     radioactivity including excretion mass balance, excretion pathways and metabolism following~     the intravenous and oral administration of [14C] BI 1356 BS~   "
66753|NCT02183597|"~     Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate~     diagnostic accuracy through application of optimized protocols for screening of cancer~     patients.~   "
66754|NCT02183584|"~     Investigation of the bioavailability of linagliptin after concomitant multiple oral~     administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison~     to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)~   "
66755|NCT02183571|"~     Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in~     the strengths of 1000 mg (part I) and 500 mg (part II)~   "
66712|NCT02184130|"~     The long-term goal of this research is to advance our knowledge of how information from the~     labyrinth is brought to perception and how adaptation to vestibular imbalance influences~     motion sensation. Patients with vestibular disorders frequently have disabling disturbances~     of perception. Related to these symptoms is that large areas of the cerebral hemispheres and~     the cerebellum receive information from the vestibular, visual and somatosensory systems~     that is integrated within a vestibular cortical network into an accurate perception of~     spatial orientation. Interrupting the pathways that process information about the direction~     of gravity and angular velocity leads to impairment of the internal estimate of gravity and~     the perception of body motion. The strategy of this research is to use repetitive~     transcranial magnetic stimulation (rTMS) to produce transient focal lesions that allow study~     of acute loss of function within the central vestibular pathways at the very beginning of~     adaptation. Our underlying hypothesis is that the immediate effects of a lesion in the~     cerebellum will be to affect ocular motor control of vestibular reflexes and perception~     alike but with a cortical lesion there will be dissociation between ocular motor control and~     perception. This research helps to understand the mechanisms involved in the perception of~     vestibular information and the cerebellar influence on processing vestibular input and~     offers a unique opportunity to make major inroads into the understanding and eventually~     treatment of the often incapacitating symptoms of patients with vestibular disease~   "
66713|NCT02184117|"~     The purpose of this study is to determine the diagnostic performances of iodine contrast~     medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will~     be measured using standard adenosine. We hypothesize that contrast FFR will offer superior~     diagnostic agreement compared to resting conditions.~   "
66714|NCT02184104|"~     The purpose of this study is to determine how fast caffeine gets into your body with a~     product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then~     put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is~     deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the~     membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the~     absorption of caffeine after using the Aeroshot™ with the absorption after drinking an~     energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in~     your blood. You will also be asked to fill out some scales to measure the effects you feel~     after the caffeine dose. We hypothesize that caffeine absorption after inhalation will be~     faster than after an energy drink.~   "
66715|NCT02184091|"~     Study to assess the effects of varying degrees of renal dysfunction and hepatic~     insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites~     in order to establish an appropriate dose and/or dosing frequency for renally- and~     hepatically-impaired patients~   "
66716|NCT02184078|"~     Study to determine the effects of nevirapine on the steady state pharmacokinetics of~     rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in~     combination with rifabutin~   "
66717|NCT02184065|"~     Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican~     population with rheumatic diseases~   "
66718|NCT02184052|"~     Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment~     of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful~     inflammatory conditions.~   "
66719|NCT02184039|"~     Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with~     rheumatic diseases.~   "
66720|NCT02184026|"~     The study implements a trauma-related nightmare treatment for children aged 8 to 13 years.~     Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration,~     academic indicators, and sleep quality will be examined.~   "
66721|NCT02184013|"~     This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan~     imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial~     fibrillation and in guiding an innovative AF catheter ablation strategy.~      It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis~     with enhanced imaging and performing an individualized innovative AF catheter ablation will~     result in higher procedural success rates.~   "
66722|NCT02184000|"~     AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in~     chronic hepatopathy~   "
66723|NCT02183987|"~     Chronic kidney disease (CKD) and its end stage of kidney failure requiring dialysis are~     important contributors to morbidity, mortality and health care costs. Over the last two~     decades, there has been a strong secular trend in the earlier initiation of dialysis for~     treatment of kidney failure from progressive CKD. These trends have occurred in spite of~     evidence showing harms with early dialysis initiation and increased health care costs.~     Recently, investigators from the Canadian Society of Nephrology, including study~     co-investigators, have proposed clinical practice guidelines to recommend an~     intent-to-defer approach for dialysis initiation. Whether these guidelines require an~     active knowledge translation strategy or they will simply translate through passive~     dissemination is unknown.~      In the investigators' proposed national cluster parallel group randomized clinical trial, we~     will randomize CKD clinics across Canada to an active knowledge translation strategy to~     defer dialysis initiation or passive dissemination of guidelines (current practice). The~     unit of observation will be the patient (i.e., outcomes will be measured at the level of an~     individual patient), and the unit of randomization will be at the level of the~     multidisciplinary CKD clinic. The investigators will then evaluate the kidney function~     (estimated glomerular filtration rate - eGFR) at dialysis initiation for all dialysis starts~     originating from these clinics to examine whether our KT strategy is safe and effective at~     delaying dialysis initiation. Our active KT strategy, if effective, will have a significant~     impact on patient morbidity and health care costs.~      The investigators' hypothesis and specific aims are as follows:~      Hypothesis: The investigators hypothesize that the clinics randomized to the active KT~     strategy will start a greater proportion of patients on dialysis later (eGFR below 10.5~     ml/min/1.73m2) compared to the control.~      Aim 1 - Efficacy: To compare the impact of an active KT intervention with passive guideline~     release on the proportion of patients followed by a Nephrologist ( > 3 months) who start~     dialysis with an eGFR >10.5ml/min/1.73 m2 across the randomized CKD clinics (clusters) in~     Canada.~      Aim 2 - Safety: To compare the impact of an active KT intervention with passive guideline~     release on safe dialysis initiation (acute unplanned dialysis starts) across the randomized~     CKD clinics in Canada.~   "
66724|NCT02183974|"~     The aim of the study was detection of pepsin in effusion in children with OME using Peptest~     as new quick and cheap method of detection and comparison results with results of other~     studies in which pepsin was detected by more demanding methods. Such a type of study hasn't~     been done so far.~   "
66725|NCT02183961|"~     Detection of extraesophageal reflux (EER) in children with chronic otitis media with~     effusion (OME) using three different diagnostic methods and selection of the group of~     patients with severe EER who could potentially benefit from antireflux therapy.~   "
66726|NCT02183948|"~     The purpose is to test whether oxytocin has an effect on masked facial expressions~   "
66727|NCT02183935|"~     Obesity and its complications have a significant effect on morbidity and mortality in these~     subjects. Especially at risk are subjects with extremely increased BMI (above 99th~     percentile for age and gender in adolescents). In these subjects classical treatment with~     diet and cognitive therapy has a limited effect. Bariatric procedures, at the moment, are~     the only feasible therapeutic possibility.~      Bariatric procedures are based on several principles; restrictive, malabsorptive and~     combined. They can be surgical or endoscopic. The later are used in subjects that do not~     qualify for surgical procedures that decline them or are used before a planed definite~     bariatric procedure.~      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to~     decrease body weight and ameliorated obesity complications, especially those associated with~     diabetic state.~      Aims of the study are:~        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in~          adolescents.~        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of~          morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion~          pattern, altered secretion pattern of gastrointestinal hormones in adolescents.~        -  To visualize functional alternations in the selected central nervous system regions~          associated with appetite regulation upon insertion of DJL.~   "
66728|NCT02183922|"~     Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with~     microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body~     composition, insulin resistance and lipid profile in women with metabolic syndrome and~     genotype Pro12Pro in the PPAR gamma 2 gene.~   "
66729|NCT02183909|"~     The overall goal of the CRUSH project is to enhance and extend a response to the local~     HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions~     across the continuum of HIV prevention and care, targeting individuals and communities most~     vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of~     California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and~     several key community-based organizations, are engaging in a participatory partnership to~     enhance and implement HIV services which target the East Bay's highest risk population-~     young men who have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to~     evaluate a combination of program approaches to address the sexual health care needs of~     young gay men of color and their sexual partners by enhancing the current program activities~     of the Downtown Youth Clinic (DYC).~      We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC~     services structure in two ways. We intend to expand HIV testing, and linkage to and~     retention in care for youth who test HIV positive, providing them with intensive~     risk-reduction counseling and antiretroviral treatment, and thereby ultimately reducing the~     risk of further HIV transmission. And we intend for the first time to offer a comprehensive~     combination package of preventive services to HIV-negative youth, including routine accesses~     to HIV/STI screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).~      The CRUSH Project will also have a substudy that will enroll HIV-negative participants who~     are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability~     of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual~     acquisition of HIV-1 in Y/MSM of color.~   "
66730|NCT02183896|"~     The purpose of this research project is to assess the effectiveness of intra-articular~     injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our~     hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and~     chondral healing following microfracture performed during femoroacetabular impingement (FAI)~     hip arthroscopy.~   "
66731|NCT02183883|"~     To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer~     (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as~     opposed to non-dominant (≥5 to <50%) or low frequency mutations (<5%).~      This trial will only be available to patients registered to the TRACERx study (NCT01888601).~   "
66732|NCT02183870|"~     EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients~     with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated~     with 250mg crizotinib bid until progression or intolerable toxicity.~   "
66733|NCT02183857|"~     The use of ultrasound guidance by senior residents learning the technique of femoral artery~     catheterization is superior to the landmark technique.~   "
66734|NCT02183844|"~     It is important that individuals with serious mental illness make informed choices among~     alternative healthcare treatments based on their preferences. However, at present,~     individuals' preferences are often not being elicited, nor used to guide which treatments~     are made available. In this pilot project, the investigators implement and evaluate a~     computerized method for assessing treatment preferences of individuals with schizophrenia.~     The investigators use weight management treatments for this initial test of the system. If~     this assessment method is found to predict treatment use and satisfaction, it can be used to~     guide implementation of treatments that improve outcomes while meeting individuals'~     preferences.~   "
66735|NCT02183831|"~     This study was set up to identify clinical outcomes including a refractive shift or change~     in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the~     eyes without zonular instability.~   "
66736|NCT02183818|"~     We aim to use an integrated network systems approach to analyze certain existing small~     airway epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene~     expression, microRNA and metabolomic levels, to develop an initial model of network~     connectivities and key network pressure points relevant to SAE biology in health and~     disease.~   "
66737|NCT02183805|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~   "
66756|NCT02183558|"~     Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy,~     insulin sensitivity decreases. The investigators examine glucose metabolism during oral~     glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective~     cohort of pregnant women with PCOS and controls.~   "
66757|NCT02183545|"~     The objective of this single rising dose study (SRD) is to investigate safety, tolerability,~     and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.~   "
66758|NCT02183532|"~     Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of~     5 mg in Chinese healthy subjects~   "
66784|NCT02183194|"~     The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter~     (CE mark) for use as intended in the treatment of subjects with clinically significant~     hemodialysis vascular access stenosis or occlusion.~   "
66738|NCT02183792|"~     Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with~     worse prognosis. In addition to its prognostic value, hyponatremia may have importance~     during the acute management of HF. We've recently shown that acute or chronic hyponatremia,~     especially <130 mEq/L, was associated with higher loop diuretic dose requirements and more~     frequent need for escalation of the diuretic regimen to achieve the same level of diuresis~     as normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous~     approach to the management of volume overload in HF, especially in patients presenting with~     concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the~     comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to~     conventional diuresis with a furosemide-based regimen on short-term clinical and treatment~     outcomes in hyponatremic acute HF patients.~      This will be a prospective, open-label, parallel-group, randomized study comparing a~     tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based~     regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with~     acute HF and signs of volume overload, and serum sodium less than 135 mEq/L will be~     randomized to tolvaptan or furosemide treatment arms. The initial 24 hours of study~     treatment will compare tolvaptan monotherapy to furosemide monotherapy. After the initial 24~     hours, treatment regimens may be altered to achieve desired clinical goals. Patients will be~     followed for up to 96 hours and at discharge for study purposes.~   "
66739|NCT02183779|"~     The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids~     (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with~     Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response~     after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.~   "
66740|NCT02183766|"~     Some prebiotics are useful for improving symptoms related to constipation, but clinical~     trials including infants and older children are scarce. A double-blind, placebo-controlled,~     crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides~     (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16~     years of age, who spontaneously sought medical care at a primary healthcare unit, received~     1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout~     period and a 30-day use of an alternative product. A clinical score was calculated at~     baseline, at the 15th (D15) and 30th (D30) day of each period, to assess bowel movement~     frequency, straining/ pain during defecation and stool consistency. Oral anal transit time~     with activated charcoal was determined at baseline and D30 of each period.~   "
66741|NCT02183753|"~     This study is focused on the pathophysiology underlying the association between exposure to~     particulate pollutants and risk for/response to viral infection. The investigators~     hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced~     granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.~     Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,~     the purpose of the study is also to test novel assays of granulocyte activation (Doershuk~     lab) and lipid mediator activation (Albritton lab) which have not previously been used in~     this type of research.~      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo~     controlled study comparing NLF granulocyte responses to LAIV administered after either WSP~     or clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean~     air), followed by a standardized dose of LAIV and serial post-infection sampling of nasal~     lavage fluids, nasal biopsy and blood~   "
66742|NCT02183740|"~     Fecal incontinence (FI) has an increasing prevalence in the geriatric population which~     cannot be explained by co-morbidity or anatomical and psychological changes of aging alone.~     In the nursing home population previous studies suggest a prevalence between 10 and 69%, but~     is most often reported to be between 40 and 55%. FI leads to a high direct and indirect~     economic burden to the health-care system, and is an important cause og institutionalization~     of the elderly patients. In addition, FI is associated with shame, social isolation and~     reduced quality of life.~      The importance of identifying treatable causes of FI in the frail elderly, rather than just~     managing passively, is strongly emphasized. It is indicated that the level of awareness~     among health personnel regarding appropriate assessment and treatment options is limited,~     and that FI is considered a normal part of aging.~      This study is based on the assumption that FI among nursing home patients can be prevented,~     cured or ameliorated by offering nursing home staff knowledge of best practise. The primary~     objective of the study is to test the hypothesis that a multifaceted educational program for~     staff on assessment and treatment of FI, is associated with a reduction in patients'~     frequency of FI.~      The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated~     cross-sectional approach.The results will be analysed according to multilevel and~     longitudinal modelling, and the study will use mixed effect models with the cluster treated~     as a random effect.~   "
66743|NCT02183727|"~     The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament~     versus Hamstring Autograft for treatment of acute rupture of the ACL.~   "
66744|NCT02183714|"~     To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared~     to placebo in patients with mild to moderate insomnia.~   "
66745|NCT02183701|"~     The general aim and clinical objective of this trial is to determine the effect of~     telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on~     reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed~     by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff~     measurements at the end of the treatment.~   "
66746|NCT02183688|"~     To confirm the combination rationale for the combination of ASA + paracetamol + caffeine~     compared with the combination of ASA + paracetamol and the individual substances ASA,~     paracetamol, caffeine, and placebo administered orally to headache patients for two headache~     episodes~   "
66747|NCT02183675|"~     To assess drug drug interaction through pharmacokinetics investigation at steady state of~     Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different~     formulations in healthy Japanese male subjects~   "
66748|NCT02183662|"~     To investigate safety and pharmacokinetics of BI 224436 ZW~   "
66809|NCT02182869|"~     Study to evaluate the safety of combivent delivered in two different formulations~     (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI),~     using a cumulative dose response model in patients with COPD.~   "
66759|NCT02183519|"~     The purpose of this research study is to test cough function in individuals with Parkinson's~     disease and healthy older adults. Cough is a complex, defensive function which involves~     movement of the chest and lungs. The investigators want to compare the movement of the chest~     wall and the lungs during voluntary and reflex cough.~      The long-term goal of this research is to develop treatments for people with cough~     dysfunction. Cough dysfunction increases the risk for respiratory infections such as~     pneumonia. The results from this study will provide information to help researchers~     understand the difference between reflex and voluntary cough more fully.~   "
66760|NCT02183506|"~     Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple~     oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI~     1356 BS and metformin given alone~   "
66761|NCT02183493|"~     To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5~     mg BI 1356 tablet administered as a single dose~   "
66762|NCT02183480|"~     Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg~     tablets of linagliptin~   "
66763|NCT02183467|"~     Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval~   "
66764|NCT02183454|"~     To collect post marketing surveillance data on patients receiving at least one Combo~     Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data~     will be collected in order to assess the long term safety and performance of the Combo Stent~     in routine clinical practice.~   "
66765|NCT02183441|"~     Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor~     ritonavir on the pharmacokinetics of BI 1356~   "
66766|NCT02183428|"~     The objective of this study was to investigate the effect of multiple doses BI 1356 given~     once daily in the estimated highest therapeutic dose of 5 mg until steady state on the~     pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of~     1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg~     being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was~     investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in~     combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD~     1750 were determined at steady state of BI 1356 when given alone or in combination with~     glyburide.~   "
66767|NCT02183415|"~     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     1356 BS during 4 week treatment duration~   "
66768|NCT02183402|"~     The purpose of this study is to investigate the pharmacokinetics, safety and tolerability of~     digoxin with and without co-administration of BI 1356. Additionally the steady state~     pharmacokinetics of BI 1356 when co-administered with digoxin will be determined.~   "
66769|NCT02183389|"~     To investigate whether and to what extent BI 1356 affects pharmacokinetic and~     pharmacodynamic parameters of warfarin~   "
66770|NCT02183376|"~     To investigate the influence of mild, moderate, and severe liver impairment on the~     pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with~     normal hepatic function after single or multiple oral administration of 5 mg linagliptin~     tablets~   "
66771|NCT02183363|"~     Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations~     (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF~     IIb~   "
66772|NCT02183350|"~     The primary objective of the current study was to investigate the safety and tolerability of~     BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and~     10 mg over 12 days in male patients with type 2 diabetes.~   "
66773|NCT02183337|"~     Study to investigate the bioavailability of BI 1356 with and without co-administration of~     pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI~     1356~   "
66774|NCT02183324|"~     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese~     patients with type 2 diabetes mellitus.~   "
66775|NCT02183311|"~     Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356~     BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg,~     and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12~     days)~   "
66776|NCT02183298|"~     Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI~     1356 as formulation for intravenous administration~   "
66777|NCT02183285|"~     To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and~     film-coated tablets~   "
66778|NCT02183272|"~     The objective of the current program of research will be to test whether intranasal ketamine~     treatment is more effective than placebo in reducing suicidal ideation in suicidal patients~     presenting for acute treatment in emergency department settings. Secondary objectives will~     test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine~     and the correlation of speech patterns and facial movement patterns with subjective~     reductions in suicidal ideation after ketamine treatment.~   "
66779|NCT02183259|"~     To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma~     concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to~     healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150~     CL.~   "
66780|NCT02183246|"~     Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to~     radiotherapy in postoperative head and neck a cancer patients as well as assessment of~     population pharmacokinetic parameters.~   "
66781|NCT02183233|"~     The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica~     (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised~     placebo controlled trial during a 28-day treatment duration.~   "
66782|NCT02183220|"~     The objective of the study was to evaluate the efficacy, safety and tolerability of a single~     peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid~     in 2 episodes of moderate tension headache.~   "
67711|NCT02171052|"~     To investigate the bioavailability of dabigatran with and without concomitant administration~     of digoxin and the bioavailability of digoxin with and without concomitant administration of~     dabigatran etexilate~   "
66787|NCT02183155|"~     The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15~     mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an~     active control to assess trial sensitivity on bleeding time in healthy subjects. The~     secondary aim of this study was to assess effects of treatment on other platelet function~     and coagulation parameters.~   "
66788|NCT02183142|"~     The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic~     tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany~   "
66789|NCT02183129|"~     To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac~     100mg SR once daily over a treatment period of 8 weeks~   "
66790|NCT02183116|"~     To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of~     56 days~   "
66791|NCT02183103|"~     Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam~     rapid releases tablet~   "
66792|NCT02183090|"~     Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg~     meloxicam injection in comparison to the 15 mg oral tablet~   "
66793|NCT02183077|"~     Study to gain information on the percutaneous absorption of meloxicam after administration~     of a topical gel over 7 days.~   "
66794|NCT02183064|"~     Study to compare the percentage of treatment successes or failures in patients randomized to~     meloxicam 7.5 mg vs. usual care prescription NSAIDs. Additionally, health care utilization,~     efficacy and safety of patients in a managed healthcare setting with osteoarthritis (OA) of~     the hip, knee, hand or spine will be assessed.~   "
66795|NCT02183051|"~     To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and~     1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg~     administered in a single dose, over an observation period of 6 hours in the treatment of~     pain after surgery of the third molar.~   "
66796|NCT02183038|"~     Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15~     mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non~     bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.~   "
66797|NCT02183025|"~     To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with~     Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation~     period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea~   "
66798|NCT02183012|"~     -  Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet~          (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under~          fasted conditions.~        -  Study to determine the relative bioavailability of ibuprofen following single~          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg~          ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.~        -  Study to determine the relative bioavailability of ibuprofen following single~          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg~          ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet~          (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.~        -  Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three~          formulations.~   "
66799|NCT02182999|"~     The aim of this study is to investigate the effect of continuous wound infiltration with~     ropivacaine in comparison to standard pain management after elective distal metatarsal~     osteotomy for postoperative pain control.~   "
66800|NCT02182986|"~     Solid organ transplantation is an important therapeutic option for children with a variety~     of end stage diseases. However, the same immunosuppressive medications that are required to~     prevent the child's immune system from attacking and rejecting the transplanted organ can~     predispose these individuals to developing a very serious cancer that is linked to~     Epstein-Barr virus (EBV).~   "
66801|NCT02182973|"~     This study is designed to develop pilot data on the acceptability and benefit of donor human~     milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal~     (GI) sub-scores, as well as total scores, will be compared between infants historically fed~     formula and those enrolled in a 2-week donor human milk study period.~      Purpose of study: to test the following null hypothesis:~      Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to~     opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan~     scoring tool when compared to (historic) infants fed formula.~      A rejection of the null hypothesis will be used to design a randomized trial of donor human~     milk in infants with NAS.~   "
66802|NCT02182960|"~     Pharmacokinetics (relative bioavailability), safety and tolerability~   "
66803|NCT02182947|"~     Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have~     been retrospective with the main goal of making a diagnosis in patients with suspected IBD.~     The current study is the first prospective study in children with known IBD assessing the~     roles of MRE and WCE in identifying disease exacerbation. This study will help to identify~     if capsule endoscopy is superior or complementary to MRE in the evaluation of suspected~     disease exacerbation in IBD patients.~   "
66804|NCT02182934|"~     To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy,~     recreational sports people and to assess the safety of the product.~   "
66805|NCT02182921|"~     The purpose of this study is to evaluate the visual outcome of the cataract surgery,~     including best uncorrected and corrected visual acuity, spherical equivalent, wavefront~     aberration and other measurements.~   "
66806|NCT02182908|"~     The primary aim of the study is to determine if the evolutivity of global and segmentary~     captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is~     predictive of the 9 month evolution of diameter and volume of the aneurysm, measured~     globally and segmentary in angioscan.~   "
66807|NCT02182895|"~     The purpose of this research study is to test the safety and efficacy of a drug called~     saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized~     patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an~     HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.~   "
66808|NCT02182882|"~     Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in~     healthy, recreational sportspeople and to assess the safety of the product~   "
66810|NCT02182856|"~     Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with~     COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen~     saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary~     disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.~   "
66811|NCT02182843|"~     The purpose of this study is to assess the clinical and radiographic outcomes in patients~     who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical~     allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be~     compared to published data for autograft in NDI (Neck Disability Index) improvement and~     radiographic success of fusion.~   "
66812|NCT02182830|"~     This trial is designed to investigate the efficacy and safety of empagliflozin compared with~     placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since~     hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular~     complications, assessment of both glucose and BP lowering effects of empagliflozin in~     hypertensive African American patients with type 2 Diabetes Mellitus could provide~     clinically highly relevant, new information for the use of empagliflozin.~      Essential hypertension is four times more common in African Americans than in Caucasians.~      One of the risk factors for hypertension is sodium sensitivity and approximately one third~     of the essential hypertensive population is responsive to sodium intake. There is a higher~     association of hypertension with sodium sensitivity in African American patients with type 2~     Diabetes Mellitus.~      The treatment duration of this trial (24 weeks) will enable assessment of the clinically~     relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic~     control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP~     (DBP) at 12 and 24 weeks.~   "
66813|NCT02182817|"~     This prospective cohort study aims to determine if apparently healthy children with no~     significant co-morbidities who undergo general anaesthesia for minor surgery before 1 year~     of age will develop measurable deficits in neurocognitive development compared to apparently~     healthy children with no significant co-morbidities who do not undergo general anaesthesia~     or surgery.~   "
66814|NCT02182804|"~     This descriptive cross sectional study aims to directly compare the diagnostic capability of~     the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging~     (M-NBI) in the Lugol's voiding lesions.~   "
66815|NCT02182791|"~     Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl~     estradiol (EE)/norethindrone (NET).~   "
66816|NCT02182778|"~     To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for~     unresectable biliary tract cancer.~   "
66817|NCT02182765|"~     Study to determine the effects of 28 days of nevirapine treatment on the steady-state~     pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics~     of nevirapine in combination with amprenavir and abacavir compared to historical controls~     treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of~     nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical~     laboratory data.~   "
66818|NCT02182752|"~     The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine~     local anesthetic solution in interscalene brachial plexus block for shoulder surgery.~   "
66819|NCT02181777|"~     The purpose of this study is to assess the feasibility of a social skills training group for~     people with psychosis.~   "
66820|NCT02181764|"~     The objective of this study is to assess the safety and tolerability of KRN23 after a single~     subcutaneous (SC) administration in subjects with X-linked hypophosphatemic~     rickets/osteomalacia (XLH) in Japan or Korea.~   "
66821|NCT02181751|"~     Our goal in this study is to decrease the severity of Post-Traumatic Stress Disorder~     symptoms in sexually abused children between the ages of 8-12. We also aim to improve~     children's quality of life, decrease levels of anxiety and depression as well as improve~     their levels of attachment.~   "
66822|NCT02181738|"~     The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously~     treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma~     subjects.~   "
66823|NCT02181725|"~     The purpose of this study is to evaluate whether a multimodal rehabilitation program~     effectively reduces functional disability in adolescents with chronic musculoskeletal pain,~     compared to care as usual.~   "
66824|NCT02181712|"~     To assess the safety and feasibility of mesenchymal stem cells therapy in patients with~     transplant related bronchiolitis obliteran syndrome (BOS)~   "
66825|NCT02181699|"~     This is a first in human, non-randomized, open-label, dose escalation study to investigate~     the safety, pharmacokinetics, immunogenicity and pharmacodynamics of repeat doses of~     KHK2823.~   "
66826|NCT02182739|"~     Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug~     tolerability.~   "
66827|NCT02182726|"~     The aim of the study is to investigate~        -  the indication for MOBEC in a dose of 15 mg per day~        -  the treatments patients were receiving before switching to 15 mg MOBEC~        -  how treatment with 15 mg is assessed compared with previous treatment~        -  how effective and safe treatment with 15 mg MOBEC is considered~   "
66828|NCT02182713|"~     The purpose of this study was to evaluate whether 2 puffs of fixed combination of~     aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg~     ipratropium bromide confers significant additional protection against metacholine induced~     bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100~     mcg salbutamol alone.~   "
66829|NCT02182700|"~     Study to evaluate the bronchodilator efficacy and safety of a fixed combination of~     salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus~     spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency~     room.~   "
66830|NCT02182687|"~     This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial~     chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic~     liver transplantation. We propose that SBRT will be associated with longer time intervals~     between initial treatment and the need for retreatment, compared to TACE, as a bridge to~     orthotopic liver transplantation.~   "
66831|NCT02182674|"~     Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA)~     inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two~     puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC)~     inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The~     dose response profile, safety and pharmacokinetics of Combivent HFA formulation are to be~     characterized.~   "
66832|NCT02182661|"~     The objective of this study is to investigate the long-term safety of Ba253BINEB.~     Secondarily the long-term efficacy of Ba253BINEB is also investigated.~   "
66833|NCT02182648|"~     This research through using bispectral index to guide the induced dose and speed of~     etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference~     for clinical anesthesia physician.~   "
66834|NCT02182635|"~     The objective of this study is to investigate the long-term safety of Ba253BINEB.~     Secondarily the long-term efficacy of Ba253BINEB is also investigated.~   "
66835|NCT02182622|"~     The purpose of this study is to first determine the highest dose of LDE225 combined wtih~     Docetaxel and Prednisone that can be given that does not cause unacceptable side effects~     when given to patients with castrate resistant prostate cancer who failed previous docetaxel~     therapy.~   "
66836|NCT02182609|"~     The objectives of this study are:~        -  To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128~          administered as an intravenous bolus over 10-20 seconds.~        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of~          99mTc-rhAnnexin V-128 in normal healthy adult volunteers.~   "
66837|NCT02182596|"~     For several years, the effective standard induction chemotherapy for AML has been limited to~     the association of anthracycline and aracytine. GO is the first effective targeted antibody~     used in leukemia patients. In a previous study, we showed efficacy and safety of~     fractionated doses of GO used as a single agent for treatment of adult AML patients in first~     relapse. In the present study the possibility of combining fractionated doses of GO to~     escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.~   "
66838|NCT02182583|"~     The objective of this study is to investigate the efficacy and safety of Ba253BINEB during~     the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan®~     aerosol) as the comparator drug.~   "
66839|NCT02182570|"~     The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment~     of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.~   "
66840|NCT02182557|"~     Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated~     with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup~     and to confirm the appropriateness of dosage of WAL801 Dry Syrup.~   "
66841|NCT02182544|"~     Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen~     fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry~     Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801~     Dry Syrup.~   "
66842|NCT02182531|"~     Study to compare the bioavailable fraction of epinastine and pseudoephedrine when~     administered as a fixed dose combination in tablet form (new pharmaceutical formulation),~     with that obtained with each of these drugs when administered separately to healthy~     volunteers.~   "
66843|NCT02182518|"~     The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg +~     Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10~     mg alone administered twice daily.~   "
66844|NCT02182505|"~     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg~     ipratropium bromide, 1 puff t.i.d.) administered via Respimat® device gives a bronchodilator~     response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol~     hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) administered via the MDI~     (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is~     at least as good when paediatric asthma patients are treated for four weeks.~   "
66845|NCT02182492|"~     Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical~     management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy.~     Nevertheless, the postoperation medical therapy was considered as a crucial procedure for~     the success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for~     the treatment of CRS, but their effect as postoperation medical therapies of ESS need more~     clinical data to clarify.~      The purpose of this prospective, randomized,study is to determine the effect of~     glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in~     different subtypes of CRS.~   "
66846|NCT02182479|"~     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium~     bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is~     not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg~     ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at~     least as good in asthma patients treated for 12 weeks.~   "
66847|NCT02182466|"~     Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This~     is to investigate safety, quality assurance and quality control of colon capsule endoscopy.~   "
66848|NCT02182453|"~     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5,~     10, 25, and 100 mg).~   "
66849|NCT02182440|"~     The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP)~     is effective and save, and to determine the most effective dose, in the treatment of~     patients with acute kidney injury caused by sepsis.~   "
66868|NCT02182193|"~     To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120~     soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120~     drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo~     correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male~     volunteers (if feasible)~   "
66850|NCT02182427|"~     Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide~     and results in poor outcomes. However there is no universal method for diagnosing~     malnutrition. A group of experts created a set of 6 characteristics to identify~     malnutrition. The goal of this project is to determine whether these characteristics are the~     best indicators to identify malnutrition or if there are other factors that may better~     identify malnutrition. Because there is no gold standard definition for malnutrition, the~     investigators will compare the characteristics against outcomes such as length of stay,~     hospital readmission and death. Outcomes are also influenced by disease state, therefore,~     information on what brought the patient to the hospital and what happened to them in the~     hospital will be collected that allows the investigators to separate the effect of~     malnutrition from disease. The hypothesis for this study is that the malnutrition clinical~     characteristics and diagnosis criteria, as presented by the experts, are valid and reliable~     principles for the diagnosis of adult under-nutrition.~   "
66851|NCT02182414|"~     Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial~     formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet~     formulation (trial formulation I) in healthy male volunteers with the aim to identify the~     best formulation for further drug development (formulation finding part / trial part 1) and~     to investigate the effect of food on the relative bioavailability of the most promising one~     of these trial formulation II prototypes (food-effect part / trial part 2).~   "
66852|NCT02182401|"~     Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and~     BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and~     BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the~     probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).~   "
66853|NCT02182388|"~     The objective of this trial was to investigate the safety, tolerability, pharmacokinetics,~     and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral~     dosage form (tablets) without and with food.~   "
66854|NCT02182375|"~     Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI~     201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to~     investigate safety and tolerability.~   "
66855|NCT02182362|"~     The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK)~     of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS)~     following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20~     mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the~     highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase)~     were assessed in healthy male subjects with GS over a 28-day continuous drug administration~     period.~   "
66856|NCT02182349|"~     Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including~     excretion mass balance, excretion pathways and metabolism following the oral administration~     of [14C]-BI 201335 at steady state.~   "
66857|NCT02182336|"~     The objective of this trial was to quantify the effect of oral single-dose (480 mg) and~     steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and~     P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for~     the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin~     were assessed.~   "
66858|NCT02182323|"~     The objective of this study was to investigate the safety, tolerability, and~     pharmacokinetics of BI 201335 NA following administration of single rising doses from 4 mg~     to 1200 mg. In addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was~     investigated.~   "
66859|NCT02182310|"~     To demonstrate that BI 201335 does not prolong the QT interval more than placebo.~      To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects~     (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the~     cross-over part of the trial.~   "
66860|NCT02182297|"~     The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of~     BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335~     NA in healthy Japanese male volunteers.~   "
66861|NCT02182284|"~     The objective of this study was to establish the relative bioavailability of a new soft~     gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution~     formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way~     cross-over study design.~   "
66862|NCT02182271|"~     The objective of the current study is to investigate safety, tolerability, and~     pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg~     to 1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI~     201335 ZW as a liquid formulation given with and without food.~   "
66863|NCT02182258|"~     The primary objective of this trial was to assess the safety and tolerability of BIBF 1120~     administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the~     absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules.~     A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after~     single iv dosing, including dose proportionality.~   "
66864|NCT02182245|"~     The primary objectives of this trial were to determine the safety, tolerability, and MTD of~     BIBF 1120 when added to standard therapy with carboplatin and paclitaxel~   "
66865|NCT02182232|"~     The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination~     with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment~   "
66866|NCT02182219|"~     The primary objective of this study was to determine the safety and Maximum tolerated dose~     (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with~     hormone refractory prostate cancer. Secondary objectives were to characterise the~     pharmacokinetic profiles of BIBF 1120 and docetaxel and possible Pharmacokinetic (PK)~     interactions between BIBF 1120 and docetaxel and to obtain preliminary information on~     anti-tumour activity.~   "
66867|NCT02182206|"~     Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,~     pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))~   "
67712|NCT02171039|"~     To investigate the bioavailability of dabigatran with and without concomitant administration~     of atorvastatin and the bioavailability of atorvastatin with and without concomitant~     administration of dabigatran etexilate~   "
66869|NCT02182180|"~     The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF,~     the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and~     other body fluids and tissues from people who have been seriously injured or ill. The~     samples will be used to develop and assess tests and/or tools that doctors can use to decide~     the best treatment plan for seriously injured or ill military personnel and for civilians.~     Additonal protocols to use the samples will be submitted as separate protocols.~   "
66870|NCT02182167|"~     We will conduct a randomized placebo controlled trial to determine whether administration of~     intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in~     paracetamol poisoning, can improve recovery from hepatotoxicity.~   "
66871|NCT02182154|"~     To assess the metabolic profile,~      to obtain the mass balance after oral administration,~      to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and~     faeces,~      to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if~     feasible,~      to determine the protein binding of [14C]-radioactivity,~      to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a~     single oral administration of [14C]-BIBF 1120 in healthy volunteers~   "
66872|NCT02182141|"~     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,~     pharmacodynamics~   "
66873|NCT02182128|"~     Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as~     safe and tolerable treatment in Japanese patients with advanced solid tumours, overall~     safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.~   "
66874|NCT02182115|"~     Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant~     morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections~     (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire~     SSIs. Such infections double the length of hospitalization and risk of dying, and increase~     U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent~     SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA)~     strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than~     non-carriers of acquiring an SA SSI. A potential prevention approach is routine~     pre-operative screening of patients, followed by decolonization of identified SA carriers.~   "
66875|NCT02182102|"~     The primary objective was to determine the safety, tolerability and maximum tolerate dose~     (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize~     the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary~     anti-tumour efficacy information.~   "
66876|NCT02182089|"~     The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory~     adequacy derived from CVInsight and compare it with other measures in recognizing~     hypotensive events during hemodialysis..~   "
66877|NCT02182076|"~     Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120~     soft gelatine capsule with food effect (BA) in healthy subjects respectively.~   "
66878|NCT02182063|"~     The aim of this study was to evaluate the efficacy of two different doses of BIBF 1120 (250~     mg twice daily versus 150 mg twice daily) in an exploratory manner. Safety, quality of life~     and pharmacokinetic parameters on a sub-sample of 20 patients were also analysed for the two~     different doses.~   "
66879|NCT02182050|"~     The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120~     twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung~     cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety~     data for the two different dosages were collected and analysed.~   "
66880|NCT02182037|"~     A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011~     BS, on coagulation parameters.~   "
66881|NCT02182024|"~     To assess the effect of different degrees of renal impairment on the pharmacokinetics and~     pharmacodynamics of dabigatran etexilate administered orally.~   "
66882|NCT02182011|"~     Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and~     streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2~     hours after the start of treatment versus baseline values.~      Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change~     from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence~     of adverse events (AE's), in -hospital complications, major or minor bleedings and serious~     adverse events.~   "
66883|NCT02181998|"~     The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety~     and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A)~     and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective~     in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.~   "
66884|NCT02181985|"~     The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase~     with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and~     half dose tenecteplase combined with abciximab and heparin sodium (group C).~   "
66885|NCT02181972|"~     The primary objective of this study was to assess the efficacy and safety of Gingko biloba~     film-coated tablets in improving cognitive function and neuropsychological functioning of~     middle-aged cognitively intact adults.~   "
66886|NCT02181959|"~     The purpose of this trial was to evaluate the safety and tolerability of a galenic~     formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy~     volunteers.~   "
66887|NCT02181946|"~     The purpose of this study was to determine the effects of nevirapine on the steady state~     pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of~     nevirapine when given in combination with fluconazole.~   "
66898|NCT02181803|"~     This 3-part dose titration study will assess MK-8189 safety, tolerability, pharmacokinetics~     (PK), and central nervous system activity. Part 1 will assess MK-8189 administered as~     monotherapy in participants with schizophrenia. Part 2 will assess MK-8189 administered as~     add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 will~     assess monotherapy with MK-8189 in healthy participants, including those of Japanese~     descent. The primary hypothesis is that there is at least one dose of MK-8189 that is~     generally safe and well-tolerated which will have the desired PK parameters in participants~     with schizophrenia.~   "
66888|NCT02181933|"~     The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC~     (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing~     peripartum mother to child transmission of HIV (Human Immunodeficiency Virus).~      The secondary objective was to assess the overall HIV transmission rate between the 2 groups~     (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the~     relationship between infection and timing of maternal dose relative to birth, infant feeding~     method, maternal peripheral blood viral load, and other potential risk factors for~     transmission.~      Following the introduction of the second and third Amendments to the Protocol, 2 substudies~     were added. The objectives of these substudies were to evaluate the frequency of~     resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to~     determine whether there was a reversion of any resistant virus to the wild type; and to~     determine if the resistant virus was transmitted from the mother to the child.~   "
66889|NCT02181920|"~     Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients~     with moderate to severe chronic cancer pain in comparison to administration of placebo or~     diclofenac.~   "
66890|NCT02181907|"~     Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX~     capsules 10 mg by single administration in healthy volunteers.~   "
66891|NCT02181894|"~     Placing artificial airways in infants is often performed under emergent life-saving~     conditions, which necessitates a procedure that is both accurate and efficient. Intubations~     of the newborn are often necessary before an accurate weight can be reported and estimations~     are often inaccurate. The current national standard uses body weight to predict the~     appropriate tube depth yet this approach tends to place the tube too deep for the smallest~     and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The~     consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation,~     pneumothoraces and death has been suggested to cost $20 to $54 million annually.~      The morbidity and the financial impact suggest an optimal and accurate approach to place ETT~     in neonates has not been identified. Other methods to estimate the proper depth of the~     orotracheal tube have shown promise yet no comparison studies have been performed.~     Identifying the most accurate method to safely place neonatal orotracheal tubes will improve~     placement precision and reduce adverse events and their associated costs.~      Hypothesis~      Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to~     tragus length will become the most accurate method for predicting the safe depth of orally~     placed neonatal endotracheal tubes.~   "
66892|NCT02181881|"~     The investigators will pilot test the intervention by randomizing 30 couples to one of three~     conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a~     standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment~     as usual (TAU) assessment-only control condition. After randomization, intervention sessions~     will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be~     assessed pre/post intervention to evaluate intervention acceptability and feasibility.~   "
66893|NCT02181868|"~     The mandible bears a wide range of mechanical load from the contraction of masticatory~     muscles, and has a significant function in normal chewing movements. Mandibular fractures~     are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial~     fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes~     assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide~     variance exists in the reported percentage of anterior mandible fractures, aggregate~     analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal~     fixation (RIF) technique has become a common treatment for mandibular fractures, in which~     titanium plates are used in the operation. Some patients have to remove the titanium plates~     in a second operation following bone healing because of sequelae, such as stress shielding.~     Biodegradable plates and screws have been developed to eliminate the problems associated~     with titanium fixtures. In this study, we aim to compare the clinical performance between~     biodegradable and titanium fixation systems after 12 months of follow-up in fixation of~     mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress~     distributions of biodegradable and titanium fixation systems at mandibular symphysis~     solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and~     premolar and molar occlusion using finite element analysis.~   "
66894|NCT02181855|"~     Patients with atypical symptoms of objectified gastroesophageal reflux disease will be~     treated by full-thickness gastroplication and the effect of this intervention will be~     measured by questionnaires and clinical diagnostics (for example pH/MII).~   "
66895|NCT02181842|"~     The purpose of this survey is to evaluate the effects on glycemic control and to evaluate~     the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic~     patients with inadequate glycemic control and a prior history of cerebral infarction.~   "
66896|NCT02181829|"~     The purpose of this study is to find out what effects, good and/or bad, radiation has on the~     lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard~     treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without~     surgery to remove the tumors in the lungs. However, tumors often come back in the lungs~     after chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to~     radiation, this study is looking at whether radiation therapy which is targeted to the~     entire lung can further reduce the chances of the cancer returning. This type of radiation~     is commonly used in other types of sarcoma to treat the cancer once it has spread to the~     lungs and it may be very useful in synovial sarcoma as well.~      In this study, a special type of radiation will be used, called Intensity Modulated~     Radiation Therapy (IMRT). With IMRT the radiation beams are more customized to focus more~     radiation on the tumor cells while delivering less radiation to areas like the heart. The~     goal of this study is also to measure pulmonary toxicity and see if IMRT is feasible and has~     less toxicity.~   "
66897|NCT02181816|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of~     azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in~     hypertensive patients in daily medical practice.~   "
67594|NCT02172573|"~     The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole)~     tablets administered in combination with L-dopa in patients with Parkinson's disease using~     placebo and bromocriptine tablets as comparators in a double-blind design (phase III~     comparative study).~   "
66899|NCT02181790|"~     Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe~     psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be~     sufficient for treatment of some patients, psoriasis of the palms and soles is particularly~     challenging to treat, and may not respond to acitretin alone.~      In this study, the focus is on patients who have psoriasis of the palms and soles, and are~     currently taking acitretin. The aim is to initially recruit 10 patients and offer them~     treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive~     laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin~     tablet. If the side treated with the excimer laser shows greater improvement compared to the~     other side, the second part of the study will be conducted.~      In this second part, another 15 patients will be included. These patients will receive twice~     weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8~     weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin~     will lead to greater improvement of psoriasis on palms and soles.~   "
66900|NCT02181686|"~     The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP~     LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device~     system.~   "
66901|NCT02181673|"~     The purpose of this study is to evaluate the efficacy of intravenously (administration of a~     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants~     with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with~     psoriasis).~   "
66902|NCT02181660|"~     The objectives of this study are to determine the safety and tolerability of ASP2215 as well~     as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT)~     and/or determine the recommended dose (RD) of ASP2215 for the next phase in subjects with~     relapsed or treatment-refractory acute myeloid leukemia (AML).~   "
66903|NCT02181647|"~     The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse~     prevention program entitled, Safe Touches: Personal Safety Training for Children (Safe~     Touches). The main study hypothesis is that children who receive the Safe Touches~     intervention will show greater improvement on their knowledge of inappropriate touches~     compared to children who do not receive the intervention.~   "
66904|NCT02181634|"~     Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for~     curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and~     gemcitabine chemotherapy.~      The purpose of this study is to evaluate the effectiveness and safety of the combination of~     nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the~     length of time during and after treatment, that the CCA does not get worse.~   "
66905|NCT02181621|"~     This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is~     better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism~     bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.~      ◊ Trademark of Smith & Nephew~   "
66906|NCT02181608|"~     Background:~      - Researchers want to see if people with alcohol dependence have more trouble learning to~     feel calm, or learn to fear things more easily, than non-alcoholics and to study how early~     life stress (ELS) affects these things.~      Objective:~      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel~     calm than people without these conditions.~      Eligibility:~        -  Adults age 21 65 with diagnosed alcohol dependence, with/without ELS.~        -  Healthy volunteers age 21 65 with/without ELS.~      Design:~        -  All participants will be screened with medical history and physical exam. They will~          have blood and urine tests, and a psychological assessment.~        -  Participants with alcohol dependence will:~        -  be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls~          and 3 in-person visits over 3 months.~        -  follow the NIH alcohol treatment program during the study. They cannot take psychiatric~          medications.~        -  rate their alcohol craving, depression, and anxiety throughout the study.~        -  have fear conditioning and extinction sessions that use noise and mild electric shock.~          Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine~          that takes images, while they perform tasks.~        -  listen to recordings that describe stressful events. They will rate their feelings and~          have blood drawn through an intravenous (IV) line.~        -  have their hormone response to stress tested. They will take a pill and get a hormone~          via an IV, then have blood drawn.~        -  Healthy volunteers will:~        -  have 2 inpatient stays, each lasting a few days. They will answer questions about how~          they feel.~        -  have fear conditioning and extinction sessions, including fMRI.~        -  have blood drawn several times.~   "
66907|NCT02181595|"~     Background:~      - Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally~     before they turned 40. This usually causes infertility, which challenges many women with the~     condition to ask themselves, Why me? This kind of question is about our human existence, or~     what some call an existential view of life. Researchers have learned that spirituality and~     finding existential purpose help women with POI. So does meeting other women with the same~     problem. Researchers want to find new ways to help women with POI cope with it.~      Objective:~      - To develop and test a practice for women with POI called Deep Reading.~      Eligibility:~      - Women enrolled in another POI protocol, who can read and speak English.~      Design:~        -  Participants will first have an individual visit or phone call. They will describe~          spiritual or existential practices they have done. They will also answer questions~          about spiritual and existential health and daily functioning.~        -  They will join a group for 6 weekly sessions. Each session will be 60 90 minutes.~        -  In each group session, a coordinator will teach participants about Deep Reading. They~          will read a piece of up to 1000 words. They will think about the piece and then talk~          about it with the group.~        -  Between sessions, participants will practice Deep Reading at least once for 15 20~          minutes on their own. They will check in once with another group member. They will keep~          a log of these activities.~        -  After session 3, participants will answer questions online about wellbeing and~          satisfaction.~        -  At session 6, participants will answer questions online about wellbeing. They will~          answer questions about their overall experience.~        -  One and 3 months after the sessions end, participants will again complete online~          wellbeing questionnaires and report on their continued practice of Deep Reading.~   "
66918|NCT02181452|"~     Chronic liver disease/fibrosis can be the result of various causes, and the result is that~     the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer®~     ultrasound system, is a method that can be used to measure the stiffness of organs in the~     body, for example the liver.~      This study will evaluate how this technology performs as a non-invasive test to stage liver~     fibrosis in patients with chronic liver disease.~   "
66932|NCT02181270|"~     Individuals with obesity and particular type 2 diabetes have abnormally high levels of fat~     in liver cells and are at increased risk for cardiovascular and liver-related mortality.~     Prior research has shown that caloric restriction, exercise, and behavior modification can~     help lower hepatic fat levels in these individuals. Additional research has also shown that~     exercise independent of weight loss can reduce hepatic fat content in obese humans. The~     current exercise guidelines do not specify what type or what intensity of exercise is~     required to induce such reductions in hepatic fat. Thus, the purpose for doing this study is~     to determine if there are differential effects on liver fat with 4 wk of high intensity~     intermittent exercise compared with continuous moderate exercise in obese individuals.~   "
68551|NCT02160041|"~     The purpose of this signal seeking study is to determine whether treatment with BGJ398~     demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or~     hematologic malignancies to warrant further study.~   "
66908|NCT02181582|"~     Background:~      - A brain protein called translocator protein (TSPO) shows changes in some brain diseases. A~     radioactive drug called 11C-(R)-PK 11195 is used to take pictures of TSPO using a camera~     called positron emission tomography (PET). Researchers want to find out how well 11C-(R)-PK~     11195 takes the pictures.~      Objective:~      - To evaluate the radioactive chemical 11C-(R)-PK 11195.~      Eligibility:~      - Healthy volunteers ages 18-55.~      Design:~        -  Participants will be screened with a medical exam.~        -  Participants will have scans at up to 4 visits.~             -  PET scan using 11C-(R)-PK 11195:~                  -  A small tube (catheter) will be put into an artery at the wrist or elbow, by~                    a needle. The needle will be removed, leaving only the catheter in the~                    artery. Blood samples will be taken through this catheter.~                  -  Another catheter will be placed into a vein in the arm or hand.~                  -  11C-(R)-PK 11195 will be injected through the second catheter.~                  -  The PET scanner is shaped like a doughnut. Participants will lie on a bed~                    that slides in and out of it. They may get a plastic mask for their face and~                    head.~             -  Participants will receive a dose of emapunil by mouth. Participants will then have~               another PET scan.~             -  Participants may have a magnetic resonance imaging (MRI) scan. The MRI scanner is~               a metal cylinder surrounded by a magnetic field. The participant will lie on a~               table that can slide in and out of the cylinder. Participants will get earplugs~               for the loud knocking noises.~        -  After each scan, participants will get a follow-up phone call. Two to seven days after~          taking emapunil, participants will return for a follow-up visit.~   "
66909|NCT02181569|"~     Despite research establishing the relationship between sleep disturbances and alcohol use,~     there is no clear understanding or model for what occurs once individuals who seek inpatient~     alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate~     back into their homes and communities. The purpose of this investigation will be to~     characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol~     rehabilitation. The misuse of alcohol is a global public health concern that compromises~     both individual and societal wellbeing, resulting in an estimated 2.5 million deaths~     annually. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes~     alcoholism by craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol~     Use Disorders). The relationship between alcohol use and sleep disturbances is complex and~     bidirectional, but sleep disturbances are common among alcoholics during phases of drinking,~     withdrawal, and abstinence. Outcome expectancies, behavioral capability, and self-efficacy~     beliefs are central constructs in the Social Cognitive Theory and will be measured directly~     in this study using both quantitative and qualitative methods. A mixed methods approach will~     be used to study the following aims: a) to assess individuals' perceptions of and~     experiences with sleep during alcohol rehabilitation, b) to describe sleep patterns,~     perceptions, and beliefs among alcohol-dependent individuals throughout the transition from~     a clinical research facility providing rehabilitation treatment back to the community, c) to~     assess whether sleep-related beliefs and/or behavior of individuals are predictive of sleep~     quality or relapse to drinking, and d) to assess whether sleep quality predicts relapse.~     Adult research participants admitted to the inpatient behavioral health unit and enrolled on~     to the NIAAA intramural study NCT 0010693: Assessment and Treatment of People with Alcohol~     Drinking Problems will be recruited for participation in this study (n=215). Sleep quality~     and duration will be quantitatively assessed approximately one week prior to discharge from~     the inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be~     asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the~     transition from inpatient to outpatient. In addition to quantitative measures, qualitative~     semi-structured interviews will be conducted with a subset of 25 participants (to reach 25~     completed cases) within a week of the scheduled discharge date and again four to six weeks~     post-discharge to assess perceptions of sleep during recovery. The proposed study will fill~     a gap in the literature by characterizing sleep throughout the rehabilitation process and~     ongoing maintenance of abstinence.~   "
66910|NCT02181556|"~     One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI.~     The purpose of this study is to improve the efficacy of the chemotherapy by adding a~     protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.~      Aflibercept is a protein that has already been studied in the treatment of metastatic~     colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to~     5FU (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the~     United States. Its addition to this chemotherapy combination has in fact brought about a~     benefit in terms of progression-free survival and overall survival.~      The purpose of the study is to evaluate the efficacy and tolerance of this combination~     rather in the initial approach to the treatment of metastatic colorectal cancers and hence~     to evaluate it as 1st line treatment~   "
66911|NCT02181543|"~     The purpose of this study is to determine efficacy of intraoperative clonidine to prevent~     postoperative agitation in pediatric anesthesia with sevoflurane.~   "
66912|NCT02181530|"~     This study will use retrospective data to evaluate the safety and efficacy of OZURDEX®~     (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to~     retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as~     part of this study.~   "
66913|NCT02181517|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration to establish comparability between Japanese and~     non-Japanese.~   "
66914|NCT02181504|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration to establish comparability between Japanese and~     non-Japanese.~   "
66915|NCT02181491|"~     There has been recent interest in the role of the 5-HT1B receptor as a possible modulating~     factor in cocaine dependence, certainly in preclinical models. The Yale Positron Emission~     Tomography (PET) Center has developed a novel 5-HT1B receptor antagonist radioligand,~     [11C]-P943, which has been validated in human studies. We hypothesize that the 5-HT1B~     receptor plays a key role in cocaine dependence. The long term goal of this project would be~     to study pharmacological manipulation of the 5-HT1B receptor as a potential molecular target~     for cocaine dependence.~   "
66916|NCT02181478|"~     This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal~     cell co-transplant in treating patients with hematologic malignancies. Giving low doses of~     chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood~     and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer~     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving cyclosporine and~     mycophenolate mofetil at the time of transplant may stop this from happening.~   "
66917|NCT02181465|"~     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin~     gene and to be sensitive to the trophic effects of the gastrin in animal models. The~     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies~     that will bind gastrin-17, thus preventing the trophic activity of cancer cells.~   "
66919|NCT02181439|"~     It is a single-center, prospective clinical study of a medical device, controlled,~     randomized, non-stratified, double-blind (neither the patient nor the parents know which~     area is irradiated / practitioner who performs the measures and evaluates the class I~     achievement or non also ignores the irradiated area) .~      Children included in this clinical trial will be their own control, an area receiving LASER~     irradiation the other receiving a simulation LASER irradiation (placebo side, inactive~     laser) .~      In the maxilla, it will be segmented using a technique by the introduction of sectional side~     (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support~     for Intermaxillary Strength II (or Intermaxillary Elastics II).~      The patient should put his own Intermaxillary Elastics II, force adapted to the amount of~     class II dental, and this 24h/24. The patient should position him/herself these~     intermaxillary elastics in the first mandibular molar to the maxillary canine ; their~     action, in case of maximum mandibular anchorage, is to reduce maxillary canine in order to~     obtain reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar~     anchor is to place the roots of mandibular molars in the vestibular cortex in order to~     anchor them there. This allows the lower canines, premolars and maxillary molars under the~     action of FIM without causing mutual advancement of the mandibular arch.~      This procedure does not differ from the usual treatment. The application of laser diode~     appears, by biomodulatrice action, to show promising results on accelerating the kinetics of~     tooth movement during orthodontic treatment. The main hypothesis of the research is an~     increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest~     delay in obtaining the class I for irradiated areas vs. non irradiated ones.~      The main objective of this study is to evaluate the effect of the application of low energy~     laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II~     (Class II elastics)~   "
66920|NCT02181426|"~     Ketorolac is administered as current practice to the majority of patients undergoing knee~     arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.~   "
66921|NCT02181413|"~     The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy~     on progression-free survival (PFS), compared to placebo, in participants with newly~     diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good~     partial response [VGPR], or partial response [PR]) to induction therapy followed by~     high-dose therapy (HDT) and autologous stem cell transplant (ASCT).~   "
66922|NCT02181400|"~     This pilot study aims to establish that treatment with near infrared light (NIR) reduces~     diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive~     beneficial effect at retinal cellular level.~      Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of~     blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling~     of the central retina or macular oedema. Patients will be treated in an office~     clinic,three times a week for a treatment duration of 2 minutes per session, a total of 12~     times over the duration of 4 weeks and will be assessed at 8 weeks to establish any change~     induced in retinal oedema.Safety folllow up will be assessed at 3 and 6 months post~     treatment.~   "
66923|NCT02181387|"~     The hypothesis is if administration of acetaminophen during labor will reduce the amount of~     neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo~     capsules will be administered at the time of neuraxial analgesia placement and then~     administered every 6 hours until delivery. Overall consumption of neuraxial pain medication~     will be determined.~   "
66924|NCT02181374|"~     The purpose of this study is to evaluate the diagnostic value of serum NT - proBNP in stroke~     associated with nonvalvular atrial fibrilltion.~   "
66925|NCT02181361|"~     The Secondary Prevention of patients with an initial cardioembolic stroke associated with~     nonvalvular atrial fibrillation.~   "
66926|NCT02181348|"~     Anemia is one of the major health problems of the developing countries of the world [1].~     According to the WHO reference criteria, an adult is labeled as anemic, if the blood~     hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the~     non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a~     common laboratory finding in apparently healthy people in general population all over the~     world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to~     establish the probable cause of their anemia and thus may end up with morbidity and health~     problems, especially the young women in developing countries [4].~      Only few studies on the use of vitamin E in the correction of anemia have been published and~     hardly any on correction of mild anemia in healthy adults. The objective of this~     intervention study was to investigate the association of vitamin E supplementation with~     post-supplemental blood hemoglobin levels in mildly anemic healthy Pakistani adults.~   "
66927|NCT02181335|"~     To establish that at least one of the two doses of Budesonide, as an ethanolic solution~     inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study~     period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response,~     which is not inferior to that obtained from the dose of Budesonide inhaled from the~     Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good~   "
66928|NCT02181322|"~     Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.~     administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality~     over a dosage range of 7.5 mg to 22.5 mg~   "
66929|NCT02181309|"~     Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to~     assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.~     administration of 22.5 mg meloxicam oral suspension.~   "
66930|NCT02181296|"~     The objective of our study is to compare the degree of phrenic nerve blockade after~     interscalene block using 0.1% ropivacaine or 0.2% ropivacaine. Our hypothesis is that using~     a lower concentration of local anesthetic will result in lesser degree of phrenic nerve~     block. 40 patients will be enrolled. Half will receive the block with 0.1% ropivacaine and~     half with 0.2% ropivacaine. Phrenic nerve and diaphragm function will be assessed by bedside~     spirometry and ultrasound visualization.~   "
66931|NCT02181283|"~     National Guard members, especially those who have been combat-deployed, are at high risk for~     developing alcohol- and prescription-related drug problems. The use of novel Web-based~     interventions combined with either Web-based boosters or Peer support sessions, may have a~     major public health impact for the National Guard by reducing hazardous use of alcohol of~     prescription drugs. The aims of the study are to develop, refine and test tailored~     motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web~     vs. Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs~     (W+W; W+P) to usual care on subsequent alcohol/drug consumption and consequences, including~     injury, mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and~     12-months post-enrollment.~   "
67666|NCT02171637|"~     Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992,~     pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor~     (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective~     tumour responses~   "
66933|NCT02181257|"~     The purpose of this study is to determine if Extracorporeal Photopheresis (ECP) is effective~     in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after~     lung transplantation. Lung transplantation has become the treatment of choice for selected~     patients with end-stage lung disease. However, long-term survival after transplantation~     remains disappointing. Chronic rejection (bronchiolitis obliterans syndrome [BOS]) has~     emerged as the leading obstacle to better long-term outcomes, and represents the leading~     cause of death beyond the first year after transplantation. BOS is diagnosed by the decline~     in the FEV1 measurement from a pulmonary function test. The management of BOS has been~     disappointing. In general, BOS is treated by intensifying the immunosuppressive regimen.~     Despite treatment, most patients continue to show progressive decline in lung function~     resulting in worsening functional status, quality of life, and ultimately graft failure and~     death.~      Extracorporeal Photopheresis (ECP) has been used as a salvage treatment for progressive BOS~     with favorable clinical results in many cases showing patient improvement. On May 2, 2012,~     the Center for Medicare Services issued a decision memo statin the ECP is covered for~     Medicare beneficiaries for the treatment of BOS following lung allograft transplantation~     only wehn the procedure is provided under a clinical research study. It is highly unlikely~     that providers that currently order ECP for their BOS patients who have already failed~     optimized immunosuppressive drug therapy would be willing to randomize half of their~     patients to continue on their failed drug therapy.What is not well understood at this time,~     however, is whether certain coexisting disease states or patient-related demographic,~     functional, treatment-related or diagnostic variables might prove to have predictive value~     in identifying subsets of BOS patients that are likely, or unlikely, to experience reduced~     rate of decline or stabilization in FEV1 following ECP treatment. This is a Registry study~     to enroll 160 patients from multiple U.S. centers to (1) confirm that ECP significantly~     reduces the rate of FEV1 decline in BOS patients refractory to standard immunosuppressive~     drug therapy, and (2) capture and assess specified patient demographic, treatment-related,~     diagnostic, functional and co-morbidity- related variables that may predict outcomes after~     ECP therapy.~   "
66934|NCT02181244|"~     There is concern in the literature regarding egg consumption in diabetic people. The~     investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based~     breakfast will not increase the risk for heart disease in diabetic people but it may reduce~     inflammation, in this population characterized by chronic low grade inflammation.~      This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per~     day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk~     washout period, subjects will be allocated to the alternate treatment for additional 5~     weeks.~      Blood will be collected at baseline and at the end of each dietary period to measure plasma~     lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.~   "
66935|NCT02181231|"~     The investigators are conducting a research study to learn about the safety and benefit of~     using a medication called buprenorphine for patients with difficult to treat depression.~     This research study is testing whether combining two medications will be effective in~     treating depression when initial treatment with just one antidepressant does not relieve the~     depressive symptoms; this is what is called difficult to treat depression or treatment~     resistant depression. The two medications the investigators are using are: an~     anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is~     the generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA~     approved for the treatment of opioid dependence. The investigators are testing whether~     adding buprenorphine to venlafaxine XR enhances treatment response.~   "
66936|NCT02181218|"~     The purpose of this research study is to find the maximum tolerated dose of a drug called~     romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment~     for certain types of lymphoma, and involves the administration of three drugs: gemcitabine,~     oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of~     romidepsin, the investigators want to look at the side effects of these drugs when given~     together, as well as how the lymphoma responds to this treatment.~   "
66937|NCT02181205|"~     The investigators are attempting to determine a less invasive method of treatment for~     postdural puncture headaches that can occur after regional anesthesia. The investigators~     will be evaluating the relief of headache with those subjects receiving treatment with a~     sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of~     epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with~     post study treatment versus placebo, and potential side effects of those patients receiving~     study therapy as well as epidural blood patch.~   "
66938|NCT02181192|"~     PSA-recurrence prostate carcinoma is associated with two general problems.~        1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local,~          locoregional oder systemic relapse is available.~        2. There is no standard therapy proved by randomised clinical trials. Recommended~          radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is~          based on retrospective data.~      These difficulties may lead to a therapy potentially not adapted to patients situation of~     disease.This study aims to randomised examine if an instant radiotherapy of prostate~     PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with~     additional imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for~     reliable information about tumor location and expansion is beneficial regarding therapy~     efficiency, quality of life and social economic aspects.~   "
66939|NCT02181179|"~     The primary aim of this research study is to examine the effects of an 8-week yoga program~     on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt.~      Guided by initial studies reporting on the effects of yoga on putative mediators of smoking~     relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment~     examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of~     aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of~     the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal,~     (2) guide the development of effective alternative interventions for smokers susceptible to~     relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and~     (3) to help guide behavioral strategies for treating substance addictions broadly.~   "
66959|NCT02180919|"~     The aims of the study are to:~        1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease~          (COPD) /chronic respiratory patients by assessing the real world impact of on~          readmissions, consults, home visits, quality of life and economic endpoints.~        2. Explore the effects of telemonitoring across heart and respiratory groups with respect~          to i) factors that influence how patients integrate telemonitoring into their daily~          routines and self care behaviour and ii) how healthcare professionals use~          telemonitoring to aid decision- making.~        3. Understand the impact of telemonitoring on a variety of care pathways.~   "
66960|NCT02180906|"~     The purpose of this study is to investigate the immune response in patients with necrotizing~     soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive~     biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet~     and the following 3 days~   "
66940|NCT02181166|"~     Myofascial pain considerably affects women undergoing treatment for breast cancer, is~     characterized by the presence of myofascial taut bands and trigger points. This study aims~     to evaluate the effects of ischemic compression, high-voltage electrical stimulation and~     rehabilitation of kinesio in women with myofascial pain following treatment of breast~     cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers~     undergoing treatment for breast cancer, randomized and allocated into three groups: G1~     (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical~     stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance~     will be assessed by means of photogrammetry and baropodometry respectively. Myofascial~     trigger points will be assessed with the use of infrared thermography, algometry and~     numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will~     be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The~     volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and~     after thirty days. Normality test is used to verify data distribution and consistent~     statistical test for proper intra and comparisons between groups, being thus considered two~     factors in the comparisons, time and group. A significance level of 5% is assumed.~   "
66941|NCT02181153|"~     Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the~     last decade active research allowed to gain more precise insights in the pathophysiology of~     IBD indicating that the chronic inflammation of the intestinal mucosa is directed against~     the microbiota of the gut in particularly susceptible individuals. Genetic studies and more~     recently genome-wide association studies (GWAS) have allowed to identify over 70~     susceptibility genes which confer an increased risk of developing IBD. In the last years the~     attention of researchers has shifted to the identification of the early immunological~     changes that occur already at a preclinical stage of the disease, trying also at identifying~     the disease before it shows itself. Recently, the ability of a combination of serological~     markers in predicting the development of IBD has been demonstrated in adults. However, there~     are no studies evaluating a cohort of children at high risk for the disease, in whom the~     first immunological changes underlying the development of IBD could be studied, including a~     combination of genetic, serological, fecal and clinical markers.~      The purpose of this study is to evaluate in a population genetically well-characterized, as~     siblings and twins of patients affected with IBD, early genetic, serologic, fecal and~     clinical markers of disease, which may be present even years before developing the disease.~     The identification of these markers in predisposed individuals could help to implement~     strategies for prevention or early treatment to modify the natural history of IBD.~   "
66942|NCT02181140|"~     The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic~     ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS~     aspiration needle in GI-tumors.~   "
66943|NCT02181127|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for~     people with type 1 diabetes > 21 years old.~   "
66944|NCT02181114|"~     Because of the deceased donor organ shortage, more kidney patients are considering whether~     to receive kidneys from family and friends, a process called living donor kidney~     transplantation (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal~     disease, they are less likely to receive LDKTs. To address this disparity, this randomized~     controlled trial will assess whether Black and White transplant patients' knowledge and~     receipt of LDKTs can be increased when they receive access to the Your Path to Transplant~     computerized Expert System (YPT). This trial will also examine how other known patient,~     family, and healthcare system barriers to LDKT impact YPT's effectiveness.~      Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical~     evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program~     (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to~     one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant~     evaluation, patients in the YPT condition will receive individually-tailored feedback~     reports, coaching, and socioeconomic resource guidance associated with reducing barriers to~     access to LDKT. Control patients will receive usual care transplant education provided by~     UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and~     self-efficacy will be assessed at four time points: prior to presenting at the transplant~     center (baseline), during transplant evaluation (approximately 2 months post-baseline), and~     4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will~     be assessed 18-months post-baseline.~      At the conclusion of the study, we will have developed an innovative and cost-effective YPT~     Computerized Expert System that could be utilized to tailor LDKT discussion and education in~     different medical settings based on the needs of individual patients of different races.~   "
66945|NCT02181101|"~     This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III~     study comparing the disease free survival after randomisation in patients treated with 3~     cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles~     of Docetaxel(Doc)-chemotherapy versus 3 cycles of~     Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of~     Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the disease free survival~     after randomisation in patients treated with 2 years of Zoledronate versus 5 years of~     Zoledronate in patients with early primary breast cancer. Patients will be required to have~     histopathological proof of axillary lymph node metastases (pN1-3) or high risk node~     negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative hormone~     receptor', but are not allowed to have evidence of distant disease. Patients will have to be~     entered into the study no later than 6 weeks after complete resection of the primary tumor.~     No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and~     endocrine treatment and radiotherapy will be allowed prior to study entry and during the~     course of the study.~      After surgery, leading to R0 resection of the invasive and intraductal components of the~     primary tumor, patients will be randomized to one of the following treatments:~      First randomization~      AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m²~     i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on~     day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v.~     (Doc), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1,~     followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22~      AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m²~     i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on~     day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v.~     (Doc), administered on day 1, repeated on day 22~      Second randomization B~      BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently~     followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three~     years~      BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years~      During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid~     and 400 i.E. Vitamin D p.o. qid.~      Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen~     and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per~     day for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal~     patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®)~     1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment~     for additional 3 years. In addition to tamoxifen, all patients with positive hormone~     receptor status of the primary tumor and under the age of 40 or restart of menstrual~     bleeding within 6 months after the completion of cytostatic treatment or with premenopausal~     hormone levels as defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously~     every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine~     status will be assumed, if the following serum levels are met: Luteinizing hormone (LH) < 20~     mIE/ml, follicle stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml.~     Endocrine therapy will start after the end of chemotherapy.~      All patients with breast conserving therapy or more than 3 axillary lymph node metastases or~     in the following cases after mastectomy:~        -  T3/T4-carcinoma~        -  T2-carcinoma > 3 cm~        -  multicentric tumor growth~        -  lymphangiosis carcinomatosa or vessel involvement~        -  involvement of the pectoralis fascia or a safety margin < 5 mm.~      will receive adjuvant radiotherapy.~   "
66946|NCT02181088|"~     The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at~     different doses and alone or in combination. The study will enable us to assess the safety~     of the vaccines and the extent of the immune response in healthy volunteers. We will do this~     by giving volunteers one or two vaccinations, doing blood tests and collecting information~     about any symptoms that occur after vaccination. This is the first trial to use these~     vaccines in humans.~   "
66947|NCT02181075|"~     This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent~     (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia,~     by using focused ultrasound (FUS), to achieve enhanced intra-tumoural doxorubicin~     concentrations for the same systemic dose.~   "
66948|NCT02181062|"~     Stroke is a cruel disease that disproportionately kills and disables African-Americans,~     Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at~     particularly high risk. There is a higher incidence of hemorrhagic stroke in African~     Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans~     have up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A~     critical need therefore exists for a sustainable and scalable mechanism to disseminate~     culturally-tailored stroke knowledge/prevention education in community-based settings where~     large numbers of these high-risk ethnic minority older adult groups are regularly served,~     such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation~     (16 of which are in Los Angeles alone).~      The overall objective of the proposed study is to develop and test the implementation of a~     training program for case managers at senior centers to implement a stoke~     knowledge/prevention education program among four high-risk ethnic minority older adult~     groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop~     a culturally-tailored case manager training curriculum, implement the training at 4~     community-based sites, and evaluate the training model using a randomized wait-list~     controlled trial (n=244) testing the hypothesis that training case managers will decrease~     older adult participants' stroke risk in a sustainable fashion through increasing their~     preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3~     months).~      Findings will inform similar community-academic partnership efforts around stroke and other~     disease-specific prevention research/interventions; they will also determine next steps in~     terms of whether this case manager-centric model can be scaled up and deployed in other~     community-based settings.~   "
66999|NCT02180386|"~     The aim of the study was to assess whether the behavior, anxiety, and dental pain of~     pediatric patients during dental treatment improves when a video game is played as method of~     distraction.~   "
66949|NCT02181049|"~     Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased~     to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from~     significant excess in mortality risk associated with treatment-related complications at~     least for 25 years after the initial cancer diagnosis. In particular, the prevalence of~     cardiovascular disease seems to be elevated compared to the general population. The CVSS~     study is a multi-disciplinary cooperation project between the Institute for Medical~     Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry~     (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and~     Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz.~     The central element is a thorough clinical cardiovascular examination of all patients, which~     permits detecting subclinical disease. Therapy data will be extracted retrospectively from~     various sources. The study intends to describe the current situation of a cohort of~     approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health.~     The role of risk factors (treatment related and classic cardiovascular risk factors), as~     well as related predisposing genetic factors is investigated. The results will contribute to~     recommendations to improve follow-up care.~   "
66950|NCT02181036|"~     To identify the effects of family work shop for children with speech developmental delays.~   "
66951|NCT02181023|"~     -  Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation~          and flow limitation. These physiopathological modifications are secondary to loss of~          elastic recoil and bronchial obstruction due to emphysema.~        -  The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and~          anticholinergics. The molecules of the latter classes can be characterized by short~          lasting action (few hours), long acting action (12 hours) or ultra long acting duration~          of action (24 hours).~        -  For years the only anticholinergic (or antimuscarinic) drug other than those used by~          aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been~          launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice~          daily).~        -  The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume.~          The part of the curve that reflects lung ventilation inhomogeneity is the slope of~          phase III~        -  For COPD patients, the most important characteristic for an inhalatory drug is a prompt~          action in order to give a quick relief from respiratory symptoms, in particular~          dyspnoea.~        -  The objective of this study is to study the acute action of glycopyrronium and~          aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances,~          lung volume distribution and dyspnoea at rest in severe COPD patients.~        -  To our knowledge no study has explored these aspects before.~   "
66952|NCT02181010|"~     The BHCK study will develop, implement, and evaluate a community-based obesity prevention~     program, which operates at multiple levels of an urban food system (policy, wholesaler,~     corner stores, carryout, household, individual; in Baltimore, MD), and will improve the~     healthy food supply chain to increase affordability, availability, purchasing and~     consumption of healthy foods within low-income, minority neighborhoods.~   "
66953|NCT02180997|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Solifenacin and Tamsulosin in healthy male volunteers.~   "
66954|NCT02180984|"~     The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating~     disorder (BED) is a new category in DSM-5 highly associated with higher body mass index~     (BMI). The neural mechanisms that underlie BE are of great interest in order to improve~     treatment interventions. Brain mechanisms underlying drug and food craving are suggested to~     be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior~     cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several~     novel studies began to assess the potential benefits of brain stimulation in reducing~     craving and associated addictive behaviors with promising results. Previous findings testing~     a one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women~     identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating~     disorders reported reduction of food craving and BE, providing evidence to support a broader~     and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain~     imaging studies contributes to the understanding of psychiatric disorders and underlying~     mechanisms being target by the rTMS intervention.~      Objectives: The primary aim is to investigate the effects of rTMS over BE frequency.~     Secondary aims include the evaluation of the effects of rTMS on food craving, body weight,~     brain activity, cognition, general psychopathology, hormonal regulation and neurobiological~     markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of~     rTMS (n=30) or placebo (n=30) scattered 3 days/week.~      Expected Results: Primarily it is expected that rTMS intervention will decrease BE~     frequency. Consequently, body weight will be reduced. It is also expected that food craving~     be decreased, cognitive performance be enhanced, and neurobiological markers be improved.~   "
66955|NCT02180971|"~     The purpose of this study is to compare the extent of coronary vessel stenosis between~     coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health~     volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the~     diagnostic efficacy of MDCTA in patients with VSA.~   "
66956|NCT02180958|"~     The main objective of this study is to assess the safety at 1 month after any embolization~     session and the efficacy at:~        -  12 months post last embolization in case of treatment with embolization only~        -  12 months after additional treatment with neurosurgery~        -  36 months after additional treatment with radiosurgery~   "
66957|NCT02180945|"~     The objective of this study is to evaluate the safety (at 1 month) and the performance (at~     3-6 months) post last embolization with Onyx or Onyx associated with other embolization~     products (cyanoacrylate glue, coils, balloon, other…)~   "
66958|NCT02180932|"~     The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used~     in combination with chemotherapy. Patients treated with radiotherapy have multiple oral~     diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over~     70% of patients with head and neck cancers treated with radiotherapy have a lower level of~     dental clinical attachment and 92% have loose teeth or missing. The management of these oral~     complications is a priority in OLR oncology. The aim is to improve the oral health of~     patients to achieve a comfortable life acceptable and necessary for healing.~      This project proposes to deepen the investigation with two main objectives:~        1. To study in vivo the effect of radiation treatment on the evolution of the viral flora~          of the periodontium in a cohort of patients and matched controls.~        2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in~          producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated~          with EBV that existence were recently discovered.~   "
66961|NCT02180893|"~     Pain after robotic cardiac surgery is a known problem and is often difficult to manage.~     Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A~     paravertebral block has been shown to provide good pain relief with minimal side effects,~     however, paravertebral blocks for robotic surgery have not been well studied. Currently the~     investigators routinely perform PVB on this patient population (of 50 MV robotic cases done~     between January and October 2012, 36 received paravertebral blocks with no adverse events~     noted). The investigators believe this should be studied further and that paravertebral~     blocks will reduce the amount of additional pain medication patients require in the first 24~     hours after surgery, decrease intubation time and improve PACU and hospital discharge times.~   "
66962|NCT02180880|"~     1. Neuropathic pain in spinal cord injured patients~        1. Inclusion criteria~             -  pain intensity, visual analogue scale > 3~             -  a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above~             -  aged ≥20~        2. Method~             -  Stop pain medications~             -  Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)~             -  Check pain intensity (VAS score) with Baron's classification~   "
66963|NCT02180867|"~     This randomized phase II/III trial studies how well pazopanib hydrochloride, combination~     chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in~     combination with pazopanib hydrochloride or combination chemotherapy in treating patients~     with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by~     surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as ifosfamide and doxorubicin hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     radiation therapy works better when given with or without combination chemotherapy and/or~     pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.~   "
66964|NCT02180854|"~     Acute deterioration among hospitalised patient can result in serious adverse events like~     cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most~     events are preceeded by deteriorating vital signs, and potentially avoidable.~      To detect and treat hospitalised at-risk patients early an early warning score (EWS) was~     introduced at the investigator site. EWS measures of a number of physiological parameters~     that are aggregated to a common score, that directs monitoring frequency, clinical~     interventions and competency of the provider.~      Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious~     adverse events. The optimal monitoring frequency for this group is unknown, and presently~     based on a compromise between patient safety and work load issues.~      The aim of the present study is to explore if an 8 hourly monitoring interval (intervention)~     is correlated with a better outcome than 12 hour intervals (control), based on the number of~     patients that deteriorate to a higher EWS 24 hours after hospital admission in each group.~   "
66965|NCT02180841|"~     The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate~     with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle~     size and HDL function), central blood pressure, and indices of arterial stiffness.~   "
66966|NCT02180828|"~     The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs~     Fluconazole for the treatment of severe vulvovaginal candidiasis~   "
66967|NCT02180815|"~     The purpose of this post-market observational study is to assess the effectiveness and~     patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with~     Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is~     a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep~     Apnea System consists of an implanter kit and tongue implants. The implants are permanently~     implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent~     tongue base closure during sleep.~   "
66968|NCT02180802|"~     Motivational interviewing (MI) has been shown to be an effective strategy in targeting~     obesity in adolescents and parental involvement has been associated with increased~     effectiveness. The aim of the study is to evaluate and compare the role of parental~     involvement in MI interventions for obese adolescents~   "
66969|NCT02180789|"~     This is an open-label, single-arm, prospective interventional study to assess the~     tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied~     with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated~     with benign prostatic hyperplasia (BPH).~   "
66970|NCT02180776|"~     The objective of this study is to evaluate clinical effectiveness and the effect on quality~     of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic~     patients with moderate to severe back pain disability and to demonstrate the safety of the~     intervention through detailed reporting and analysis of adverse events.~   "
66971|NCT02180763|"~     The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment~     interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL~     according to the delivery device.~   "
66972|NCT02180750|"~     Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children~     living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the~     intervention improves outcomes compared to standard care. We aim to test the hypothesis that~     attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural~     difficulties, and self-efficacy compared to standard care.~   "
66973|NCT02180737|"~     Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing~     interventional radiological procedures and measuring its different outcome variables.~   "
66974|NCT02180724|"~     This study is evaluating the safety and efficacy of acalabrutinib for the treatment of~     subjects with Waldenström Macroglobulinemia (WM)~   "
66975|NCT02180711|"~     To characterize the safety profile of acalabrutinib alone or in combination with rituximab~     in subjects with relapsed,refractory,or treatment naive Follicular Lymphoma (FL)~   "
67000|NCT02180373|"~     The overall goal of this multicenter collaborative research study is to identify genetic,~     proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower~     extremity revascularization in patients with advanced peripheral artery disease (PAD).~   "
66976|NCT02180698|"~     This pilot phase I clinical trial studies the side effects and best dose of toll-like~     receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given~     together with radiation therapy in treating patients with soft tissue sarcoma that has~     spread to other parts of the body (metastatic) or cannot be removed by surgery~     (unresectable). TLR4 agonist GLA-SE may stimulate the immune system to kill sarcoma cells.~     Radiation therapy uses high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE~     with radiation therapy may be a better treatment to treat sarcoma that cannot be removed by~     surgery.~   "
66977|NCT02180685|"~     The purpose of this present study is to determine which surgery technic provides the best~     clinical outcome after medial patellofemoral ligament reconstruction comparing suture~     anchors and screw fixation in medial femoral condyle.~   "
66978|NCT02180672|"~     This double-blind, randomized controlled trial will evaluate the use of nasal~     corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS).~     Efficacy, duration of action and side-effects will be determined.~   "
66979|NCT02180659|"~     The primary objective of the study is to demonstrate maintenance of treatment efficacy when~     transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg~     or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.~      The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult~     outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.~   "
66980|NCT02180646|"~     This study examined the effect of a high protein or high carbohydrate breakfast on the~     glucose and insulin response following the breakfast meal, as well as the subsequent~     response following the lunch meal.~   "
66981|NCT02180633|"~     A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are~     idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about~     0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye~     of patients suffering from unilateral macular hole.~      Our hypothesis is that embedded in the topography of the retina is information that can~     allow for discrimination between healthy eyes and eyes with an increased risk of developing~     IMH. As such, our work aims to develop a system that allows the automatic identification of~     these eyes.~   "
66982|NCT02180620|"~     With many medications we prescribe them relative to time of day or a meal. This study~     established if pre dinner vs post dinner exercise was more effective at altering post dinner~     glucose and triglyceride levels vs no exercise at all.~   "
66983|NCT02180607|"~     The overall goal of the proposed project is to investigate the neuronal pathways regulating~     the effects of social acceptance and rejection in healthy controls and patients with Major~     Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit~     declaration that an individual is liked or not liked. Social acceptance can boost one's~     self-esteem and mood, whereas rejection can lower them. The neurological relationship~     between social acceptance/rejection and depressive symptoms is not known. Using functional~     magnetic resonance imaging (fMRI), it is hypothesized that social feedback will activate a~     specific interconnected neuronal pathway involved in social separation and reward. Executive~     functioning and response to monetary reward will also be assessed during fMRI using two~     additional tasks (monetary incentive delay, parametric go no-go) to determine how these~     cognitive brain functions regulate responses to social feedback.~   "
66984|NCT02180581|"~     The aim of the intervention is to examine the effect of a combination of the two bacterial~     strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic~     manifestations in small children, and how a combination of BB-12 and LGG affects the immune~     system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter~     seasons.~   "
66985|NCT02180568|"~     The study object is to demonstrate the usefulness and safety of lipiodol localization~     technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic~     surgery (VATS) resection compared to hook wire localization technique. A total of 250~     participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims~     of this study are achieved, the use of lipiodol localization technique will be widespread~     their application for localization of non-palpable pulmonary lesions that are indicated for~     VATS resection.~   "
66986|NCT02180555|"~     Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit~     (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when~     it occurs in previously non-diabetic patients, it reflects a latent disturbance of the~     glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk~     factors could support prevention, detection and early treatment of impending diabetes~     mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU~     admission to screen for disorders of glucose metabolism. Furthermore, we examined~     characteristics that could have predicted the post-discharge disturbances: patient~     characteristics, parameters of disease severity and of glucose metabolism, as well as the~     FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.~   "
66987|NCT02180542|"~     The purpose of this study is to improve secondary prevention of ischemic stroke patients by~        1. Estimating prevalence and the prognostic significance of frequent premature atrial~          complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial~          fibrillation.~        2. Characterize ischemic stroke patients by~             1. Echocardiographic characteristics~             2. Biochemical markers~             3. Plaque composition in the carotid arteries~                  -  in order to improve risk stratification.~   "
67025|NCT02180048|"~     The purpose of this study is to observe effects of caffeine on overactive bladder symptoms~     and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or~     if lower doses of caffeine decrease the effects.~      The study will propose the following hypothesis:~        1. The voiding and mental health symptoms will be greatest in the high dose treatment and~          lowest in the placebo treatment.~        2. The low dose treatment will produce more voiding and mental health symptoms than the~          placebo treatment.~        3. Voiding and mental health symptoms will be mediated by hydration status of the patient~          which will be assessed using a Tanita Scale.~   "
67026|NCT02180035|"~     To evaluate if nutritional treatment with nutritional supplementation of dietary fiber~     reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS~     receiving antiretroviral therapy (HAART).~   "
66988|NCT02180529|"~     Background: The increase in life expectancy and the rise in the ratio of older to younger~     people in the population has resulted in an increase in the number of those suffering from a~     decrease in cognitive ability, such as Mild Cognitive Impairment (MCI). Methylphenidate can~     improve cognitive ability, mainly in memory and executive function.~      Working hypothesis and aims:~      This study examines the effect of Ritalin treatment in older people suffering from MCI. Our~     hypothesis is that treatment with Ritalin will improve cognitive function in those suffering~     from MCI, especially in the domains of attention and executive function.~      Methods A randomized, double-blind, case-control study. 120 patients older than 65 years of~     age diagnosed as suffering from MCI in the past year in geriatric assessment facilities in~     Beersheva. Patients will be randomized in equal groups to either the study group (Ritalin~     treatment) and control group (placebo). Each participant will attend the geriatric unit for~     four consecutive days: on the day prior to beginning the intervention participants will~     undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants~     will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at~     10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention.~     Participants in the control group will receive placebo. Two hours after taking the drug or~     placebo participants in both groups will be assessed cognitively by means of Mindstreams and~     MoCA (Montreal Cognitive Assessment).~      Expected results: Ritalin treatment will improve the cognitive function of the subjects,~     mainly in the domains of concentration and executive function~   "
66989|NCT02180516|"~     Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal~     adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.~   "
66990|NCT02180503|"~     Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB~     reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a~     food effect for the 10 mg tablet dose group~   "
66991|NCT02180490|"~     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules~     (reference drug) of meloxicam (UHAC 62 XX) in fasted state.~   "
66992|NCT02180477|"~     Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different~     tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent~     pivotal bioequivalence (BE) study between capsule and tablet formulations.~   "
66993|NCT02180464|"~     Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a~     LAS41004 formulation vs active control No formal study hypothesis, but descriptive~     evaluation (PoC).~   "
66994|NCT02180451|"~     The purpose of this study is to characterize the circadian rhythm disruption experienced by~     patients as determined by plasma melatonin, cortisol, and other circadian analytes~   "
66995|NCT02180438|"~     There is a critical need for safe and effective antiretroviral treatment (ART) regimens for~     HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2~     million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is~     limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors~     (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad~     resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently~     observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors~     (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important~     differences in their susceptibilities with studies indicating that saquinavir (SQV),~     lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and~     cross-resistance is frequent. Although an increasing body of evidence supports the potential~     utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to~     assess their effectiveness and they are not routinely available in resource-limited~     settings. These limitations present major challenges to HIV-2 treatment, particularly in the~     areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir~     (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an~     INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators~     hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific~     Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir,~     cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected~     Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2~     antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA >250~     copies/ml) participating in the 48 week trial of STRIBILD~   "
66996|NCT02180425|"~     The purpose of this study is to evaluate the differences in the skin lipid profile of~     patients with and without acne. Secondly, the goal is to learn more about what the effects~     of retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that~     the skin lipid profile of subjects with acne will be lower in inflammatory lipids in~     comparison to subjects without acne.~   "
66997|NCT02180412|"~     This study aims to provide high quality evidence for the effectiveness and safety of hemin~     (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of~     studies have not been done before with either PanhematinTM or the hemin preparation~     available in Europe (NormosangTM, Orphan Europe).~      There are two treatment groups in this study. One group will be treated with PanhematinTM~     plus glucose, and the other group will be treated with glucose plus an inactive salt~     solution (called a placebo). To avoid prejudice, the treatment given to each participant~     will be blinded (meaning the participants and most of the hospital staff will not know which~     treatment the participant will receive) and randomized (meaning participants will have an~     equal chance of receiving either treatment, like the flip of a coin). A placebo-controlled,~     randomized study is the standard method used to prove treatments are effective and safe.~     PanhematinTM and glucose will be given in the same manner as is usual for treating an attack~     of porphyria. For participants who are chosen to receive the placebo, their treatment will~     be switched to real PanhematinTM at any time if their symptoms do not improve. This is~     called rescue treatment, and assures that they study is safe and patients who need hemin~     will receive it. Treatment with hemin will be for 4 days, or longer if needed. Since the~     study treatment is started as soon as possible after symptoms appear, there will be very~     little delay in providing hemin to those who need it. Funding Source - Office of Orphan~     Products Development (FDA OOPD)~   "
66998|NCT02180399|"~     Determination of capillary lactate by using point-of-care technique is accessible, fast~     and allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared~     to conventional assay techniques in arterial blood, capillary assay technique may have an~     increased susceptibility to metabolic alterations induced by sepsis in its initial stages.~     This increased sensitivity is not necessarily relevant in the management of the most serious~     patients for whom the diagnosis is obvious, but it could be very useful in patients for whom~     a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better~     identify patients who would require intensive management and avoid the installation of these~     serious disorders.~   "
67001|NCT02180360|"~     Background: Nowadays, a commonly used sport that helps enhancing physical fitness~     components, including flexibility, is Capoeira. This modality is defined as an athletic~     sport composed by an individual attack and defensive system, which was originally created in~     colonial Brazil. Capoeira is characterized by its main movement, the ginga, and by other~     several dodging, unbalancing, traumatizing and acrobatic movements. The literature~     empirically discusses that Capoeira contributes in general physical fitness by modulating~     several variables of human movement. Among these variables it is possible to highlight the~     influence of Capoeira in the amplitude of movement of the practitioner's joints. However, no~     study with a control group has investigated the alterations in flexibility of beginners~     using an experimental protocol based exclusively in basic techniques of Capoeira, without~     applying any usual stretching exercises that are commonly used, independently of the~     specificity of the sport. Objective: To analyze the effects of eight weeks of basic training~     in Capoeira on the flexibility of beginners in the sport. Methods: Twenty-one individuals,~     divided in two groups [Capoeira, n=13; 26.1±7.2 years; 22.7±2.7 kg.m2(-1) and Control, n=8;~     27.1±0.5 years; 24.3±3.3 kg.m2(-1)] participated in the study. The Capoeira group performed~     eight weeks of basic training (two sessions per week lasting 60 minutes each). The~     experimental protocol used was exclusively based in basic techniques of a programmed~     Capoeira training system. Before and after the intervention measurements were performed~     aiming to analyze: trunk flexion flexibility, through a sit-and-reach test using a Wells'~     Bench (WBtf); and passive tension (PThf) and maximum amplitude of hip flexion (MAhf) through~     goniometry. The hypothesis of this study is that the group Capoeira (beginners) will~     increase the linear and angular flexibility after eight weeks of basic training in the~     sport.~   "
67002|NCT02180347|"~     The objective of this study is to determine if multifocal contact lenses affect~     accommodation and/or binocular vision when worn by pediatric patients. This will be~     accomplished through subjective and objective accommodative and binocular experiments in~     children wearing single vision and multifocal soft contact lenses.~   "
67003|NCT02180334|"~     The aim of this study is to investigate the effects of combined administration of mosapride~     as modulator of gastrointestinal motility and DPP-4 inhibitor on secretion of gut hormone~     such as glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), and oral~     glucose tolerance. Additionally, change in lipid profile and insulin secretion will be also~     assessed.~   "
67004|NCT02180321|"~     Massive bleeding is expected when performing distraction osteotomy for craniosynostosis~     patients. Since such operation is performed at very young age, many efforts are performed in~     order to reduce the total amount of bleeding and the transfusion during and after the~     surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion~     during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic~     acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the~     changes in coagulopathy will be defined using thromboelastography.~   "
67005|NCT02180308|"~     The overarching goal of this study is to develop PET/MR techniques to accurately detect~     nodal metastases for surgical planning and assessment of treatment response.~   "
67006|NCT02180295|"~     The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety,~     tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is~     that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days~     after the fourth dose.~   "
67007|NCT02180282|"~     Up to 20 healthy subjects age 15-45 years old ,Skin Phototype I-V,Study will be conducted in~     1 site.~      Primary objectives is to evaluate the efficacy of IPL acne filter treatment for improvement~     of acne vulgaris as assessed by lesion count.~   "
67008|NCT02180269|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK,~     study of the way a drug enters and leaves the blood and tissues over time) of~     single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.~   "
67009|NCT02180256|"~     To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler,~     performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates~     in women who will be submitted to a fresh embryo transfer.~   "
67010|NCT02180243|"~     The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE)~     and iRest Yoga Nidra (meditation)/auricular (ear) acupuncture for Veterans with Gulf War~     Veterans' Illnesses (GWVI).~   "
67011|NCT02180230|"~     The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and~     Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant~     survival rate, soft tissue health and maintenance.~   "
67012|NCT02180217|"~     The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of~     patients with Cushing's disease. It is a pivotal trial intended to support the registration~     of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other~     countries.~   "
67013|NCT02180204|"~     This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of~     intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present~     with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.~   "
67014|NCT02180191|"~     An altered gut microbiota composition has recently been linked to obesity and diabetes. The~     principal aim of this study was to investigate and compare the gut microbiota composition of~     obese, diabetic and control individuals. Then, associations between analyzed gut microbial~     concentrations and clinical-biochemical blood parameters were assessed.~   "
67015|NCT02180178|"~     Goal of the registry is to collect data on patients undergoing coronary angiography in~     Mainz. Following amendment of the procol, this study will also include patients who received~     an Aborb bioresorbable scaffold for the therapy of de novo stenoses.~   "
67016|NCT02180165|"~     The primary objective of this study is to assess and compare the safety of posaconazole with~     voriconazole in Japanese participants with Aspergillosis.~   "
67017|NCT02180152|"~     The purpose of this study is to verify if postprandial walks are effective in obese pregnant~     women, as regards to gestational weight gain and typical diseases of that period, as~     gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as~     macrosomia, shoulder dystocia and fetal death.~   "
67027|NCT02180022|"~     Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial~     function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This~     study was designed to investigate whether consumption of onion peel extract (OPE) improves~     endothelial function in healthy overweight and obese subjects.~   "
67028|NCT02180009|"~     In this study, the investigators will dynamically detect the expression of an immune~     regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.~   "
67018|NCT02180139|"~     Dystonia is a devastating disorder defined by involuntary, sustained muscle contractions or~     abnormal postures that can affect any part of the body. Cervical dystonia (CD) is the most~     pervasive form of dystonia affecting 60-90,000 individuals in the United States alone and is~     characterized by involuntary twisting of the neck. The symptoms of CD are disabling,~     disfiguring, painful, and have a strongly negative impact on quality of life, including~     social withdrawal and depression. At present, there is no treatment that has been shown to~     have long term benefit in CD. Standard of care (SOC) is botulinum toxin, which temporarily~     paralyzes affected muscles, resulting in reduced muscle spasms. This treatment has many~     undesirable side effects, variable effectiveness, is expensive, and must be repeated every 3~     months throughout the lifespan. Physical therapy based treatments aimed at retraining~     posture or stretching dystonic muscles are largely ineffective and not typically delivered~     as a part of standard of care. There is an urgent need for novel and effective therapies.~     Emerging technologies, specifically non-invasive brain stimulation (NBS), have demonstrated~     compelling evidence to make a meaningful impact in the lives of people with CD. In this~     study, individuals with cervical dystonia will be randomly assigned to receive tDCS for 15~     minutes daily for 4 days in 1 of 4 stimulation location groups.~      Hypothesis 1: One location of stimulation will result in clear benefit with at least 1~     standard deviation (SD) improvement in the CDQ-24, the primary outcome measure, at 1-week~     follow-up.~      Hypothesis 2: The cortical silent period will be the most sensitive measure investigated and~     will demonstrate significant increase in inhibition as determined by an elongation of silent~     period in the affected upper trapezius muscle.~      Hypothesis 3: The stimulation location determined to be most effective in Objective 1 will~     produce the greatest physiologic change in inhibition increase.~      Hypothesis 4: The hypothesis for this aim is if certain characteristics can predict response~     to treatment, a strong association will be seen between baseline measure(s) and the primary~     outcome measure. A thorough assessment of characteristics including: age, sex, duration of~     symptoms, genotyping for two specific polymorphisms, botulinum toxin history, baseline~     measures of outcome variables, measures of brain excitability, and genetic testing will~     predict response.~   "
67019|NCT02180126|"~     A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a~     high probability for vasculitis has high sensitivity and specificity for vasculitis. A~     positive ANCA test result in those patients who do not have a high probability for~     vasculitis requires extensive follow-up because those patients eventually present with~     malignancy or other inflammatory diseases. The investigators wish to investigate the~     correlation between the differing levels of positive ANCA tests and their relationship to~     vasculitis, malignancy and inflammatory diseases.~   "
67020|NCT02180113|"~     FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in~     Europe since December 2003 and is currently used in many countries. FibroScan® is an~     ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to~     liver stiffness measurement (LSM).~      Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver~     fibrosis.~      Some other studies have already shown the good correlation between LSM, assessed by~     FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).~      PHT is a clinical condition characterized by a high blood pressure in the portal vein and~     its tributaries and it is defined as a gradient between portal and systemic blood pressure >~     6 mmHg.~      The development of oesophageal varices (OV) in cirrhotic patients, as well as their~     potential bleeding, represent one of the most severe and life-threatening complication of~     cirrhosis.~      Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric~     varices or congestive gastropathy, for estimating the grade of OV and for the recognition of~     the presence of red color signs and wale marks or other indicators of high risk for~     bleeding.~      However these two methods are quite invasive and associated with some risks; at the same~     time, not all cirrhotic patients present OV at endoscopic screening.~      The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition~     parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence~     of OV in liver cirrhosis patients.~   "
67021|NCT02180100|"~     The objectives of this study were to demonstrate comparable safety and efficacy of~     Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with~     severe vulvovaginal candidiasis.~   "
67022|NCT02180087|"~     Currently, the management of pain after cardiac surgery is based on the concept of~     multimodal analgesia: Combined use of non-opioid analgesics associated with morphine~     intravenous analgesia by a system controlled by the patient (patient-controlled~     analgesia-PCA).~      The combination of paracetamol and morphine PCA is very effective on pain at rest, but is~     limited on pain mobilization and causes the problem of side effects associated with opioid~     (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention~     ...) which are contributing factors to increase the length of stay in Intensive Care Unit,~     an additional cost of care and an increase postoperative morbidity and mortality.~      Methods that have proved their effectiveness on pain and mobilization used in postoperative~     cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia~     techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in~     morphine consumption, improved postoperative pain, decreased sedation and decreased~     postoperative morbidity and mortality.~      Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently,~     NSAIDs, in the absence of against-indications, should always be prescribed and used at the~     lowest effective dose and for the shortest possible time.~      Some studies have suggested that lower doses of NSAIDs didn't appear to affect their~     effectiveness. At present, the investigators have no studies that address the hypothesis~     from which minimum dose of ketoprofen analgesic effect is obtained.~      The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the~     postoperative mobilization of cardiac surgery. The investigators want to find, in their~     study, this optimal ketoprofen dose which would be the minimum dose for clinical efficacy~     demonstrated dose.~      This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will~     probably not have enough power to prove it. NSAID use at these low doses, in postoperative~     cardiac surgery, could be extended to patient populations most at risk or for a duration~     longer than 48 hours.~   "
67023|NCT02180074|"~     Cardiovascular disease which includes coronary artery disease and peripheral artery disease~     remains the leading cause of death among women in the United States. The impact of~     cardiovascular in women was not recognized by clinicians for a long time. It is now evident~     that, women suffer the consequences of cardiovascular at rates at least as high as those~     observed in men but there are still major gaps in our understanding this disease in women.~     Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular~     system. Research has demonstrated it's critical role in animal ischemia reperfusion models.~     Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has~     pioneered the development of new analytical techniques for accurate measurement of all~     biological pools of H2S. By measuring these distinct pools of H2S in women with and without~     cardiovascular disease the investigators hope to further understanding of role of H2S in~     pathophysiology of cardiovascular disease. This research will help to assess the ability of~     H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic~     target for cardiovascular disease.~   "
67024|NCT02180061|"~     This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W)~     of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive~     pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis~     is that treatment with single agent pembrolizumab will result in a clinically meaningful~     overall response rate.~   "
75768|NCT02065557|"~     The purpose of the study is to demonstrate the efficacy and safety, and to assess the~     pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with~     moderate to severe ulcerative colitis (UC).~   "
67029|NCT02179996|"~     Preterm neonates are fragile to infections. Their immune system is immature, yet in France,~     primary vaccines are injected at two months of age, as in term infants.~      Recommendations for vaccinations in infants have changed in France in 2013, suppressing the~     second injection at three months after birth. Preterm and full-term born infants are now~     vaccinated at two and four months of age, but no data regarding efficacy in very preterm~     infants have been registered.~      The investigators hypothesize that two vaccine injections (at two and four months) would be~     less efficient than three injections (two, three and four months) in very preterm-born~     infants.~   "
67030|NCT02179983|"~     Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of~     COPD, rehabilitation is associated with reduced frequency of exacerbations and improved~     exercise capacity. No data are available in bronchiectasis.~      This study will randomly assign patients with bronchiectasis exacerbations to pulmonary~     rehabilitation or standard care. The hypothesis is that exercise capacity will be improved~     by pulmonary rehabilitation at 8 weeks.~   "
67031|NCT02179970|"~     Pancreatic, ovarian and colorectal cancers are difficult to treat using chemotherapy and~     immune therapies.Currently most patients are offered treatment with a standard chemotherapy~     drug depending on their cancer type. Recently, laboratory studies have shown that a drug~     called plerixafor may help the body to overcome resistance to immune therapy.~      The purpose of this study is to find out if the study drug has the same effect on patients~     with advanced pancreatic, ovarian or colorectal cancer, as we have seen in our laboratory~     experiments, and find out the right dose of the study drug to give. This is a 'dose~     escalation study'. Patients will be recruited slowly and the study team will closely monitor~     the effect the drug has, until they find the best dose to give. As part of this study, blood~     and tumour samples will be collected and analysed in our laboratories and the patients~     cancer will be monitored using two imaging techniques, CT and FDG-PET scans.~   "
67032|NCT02179957|"~     The identification of abnormal narrowing of a blood vessel from non-invasive coronary~     angiography remains an exciting goal. While Computed Tomography (CT) has established a clear~     role in patients it retains some limitations. Primarily, alterations in blood flow leading~     to a restriction in blood supply to tissues cannot be accurately predicted from the~     anatomical assessment of an abnormal narrowing in a blood vessel - a limitation of both~     invasive, and computed tomographic, angiography. This is important, as there is now a raft~     of evidence demonstrating that revascularisation should only be considered in the presence~     of a restriction in blood supply to tissues.~      The gold standard method of identifying a restriction in blood supply to tissues is~     measurement of the fractional flow reserve (FFR), a dimensionless value generated as a ratio~     between the circulatory pressure before and after a narrowing of a blood vessel.~      At present, patients with indeterminately significant abnormal narrowing in a blood vessel~     identified using CT must go on to have a further test for a restriction in blood supply to~     tissues, prior to any decision about revascularisation being made.~      As part of our governance commitment to maintaining our reporting standards, we undertake~     ongoing audit of our cardiac CT practice. The investigators recently identified a group of~     patients who have undergone FFR measurement as part of routine clinical care, and compared~     these to our clinical reports, to ensure that appropriate recommendations were being made.~     It appeared that the ability to predict important abnormal narrowing in a blood vessel was~     reasonable (~70%) and hence we propose the formulation of a research question to explore~     this further.~      The primary objective of this study is to determine the accuracy of a visual assessment of~     the likely significance on blood flow of a narrowing of a blood vessel identified on cardiac~     CT, in comparison to invasive, fractional flow reserve.~      The secondary objective is to evaluate features of an abnormal narrowing in a blood vessel~     that is likely to have a significant impact on blood flow.~      The investigators' working hypothesis is that cardiac CT FFR is a useful predictor of~     abnormal narrowing in a blood vessel.~   "
67033|NCT02179944|"~     This project will be a prospective physiologic study. We will closely follow 60 medication~     abortion patients with serial repeat serum hCG and urine semi-quantitative hCG testing. We~     plan to recruit patients from two gestational age strata: ≤ 49 days and > 49 days.~      Study Objectives:~        1. To create a nomogram describing the change in serum hCG values in the first five days~          immediately following medication abortion with mifepristone and misoprostol.~          Specifically, we will describe the percent serum hCG decline from Day 1 (day of~          mifepristone) to Day 3 (day after misoprostol), from Day 1 to Day 5, and from Day 1 to~          Day 7-10.~        2. To explore whether there is a significant difference in the rate of hCG decline based~          on initial gestational age determined by ultrasound and initial serum hCG.~        3. To describe the correlation between semi-quantitative urine hCG test results and serum~          hCG values to determine how soon after initiating medication abortion the urine test~          can detect completed abortion.~      We hypothesize that among successful medication abortions, there will be a predictable trend~     with at least a 50% drop by Day 3 and 80% drop by Day 5.~   "
67034|NCT02179931|"~     To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet~     formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet~     formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.~   "
67035|NCT02179918|"~     This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum~     tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a~     4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in~     patients with solid tumors.~   "
67036|NCT02179905|"~     This study is to analyze the relationship between brain structure, the heart rate~     variability and the serum fatty acid component of the irritable bowel syndrome patients.~   "
67037|NCT02179892|"~     The purpose of this study is to compare the efficacy and duration of bupivacaine~     extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in~     transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory~     University Hospital and Emory University Hospital Midtown.~      The investigators hypothesize that Exparel will provide greater postoperative pain relief~     than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and~     female subjects meeting inclusion and exclusion criteria who will be randomized to receive~     either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the~     TAP block to achieve at least 22 subjects in each group~   "
67047|NCT02179762|"~     This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing~     active surveillance in patients with prostate cancer that has not spread to nearby lymph~     nodes or to other parts of the body. Active surveillance involves watching the patient's~     condition but not giving any treatment unless test results show that the patient's condition~     is getting worse. Exercise may improve fitness, quality of life, brain health, and blood~     biomarkers in patients with prostate cancer on active surveillance. It is not yet known~     whether vigorous or moderate exercise works better in enhancing active surveillance in~     patients with localized prostate cancer.~   "
67048|NCT02179749|"~     This is an 8-week, randomized, double-blind, placebo-controlled, 3 arm, parallel groups,~     dose-ranging study of 1-week of treatment with mifepristone (0, 600, 1200 mg/d) given in~     conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.~   "
67038|NCT02179879|"~     Procedural skills play an important role in anaesthetic expertise. More focused training and~     assessment of procedural skills will be needed in the future as training moves from an~     apprenticeship based training system to competency based assessment.~      Currently various techniques exists to assess procedural skills of anaesthetist. For~     epidural catheter placement, task specific check list, global rating scales and cumulative~     sum techniques have been developed and validated. These techniques aim either for better~     qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in~     objectivity in turn hampers inter-rater reliability which is an essential component of a~     valid assessment model. Checklists type assessments force the developer to comprehensively~     characterize the procedure of interest and then validate the completed procedure~     characterization. This approach has been quantitatively shown to have higher assessment~     reliability levels compared to Likert-scale assessment.~      The objective of the project is to develop and validate a comprehensive procedure~     characterization for labor epidural catheter placement. Another objective is to compare this~     new assessment tool with existing checklist and global rating scale for labor epidural to~     establish concurrent validity.5 A well-developed objective, validated procedure~     characterization serves as a master tool which has multiple applications. It helps to build~     a training programme for the procedure, allows providing metrics based feedback to trainees~     using simulator, helps to assess the performance of trainees and in future might be used as~     benchmark to allow competency based progression in the training.~   "
67039|NCT02179866|"~     This study is designed to investigate the absorption, distribution, metabolism and~     elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male~     participants.~   "
67040|NCT02179853|"~     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the~     developed world. Despite available treatment, 25% of children in San Diego County~     appropriately treated for KD develop coronary artery abnormalities that may lead to~     complications later in life, including heart attack. Although the investigators can identify~     children with KD that have these coronary artery abnormalities, there is no approved~     additional treatment to decrease coronary artery inflammation and arrest or prevent damage~     to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1~     (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to~     prevent the development of coronary artery damage. Therefore, the investigators propose to~     study the safety and activity of anakinra in infants and children < 2 years old with~     coronary artery abnormalities from KD.~   "
67041|NCT02179840|"~     One of the fundamental goals of anesthesia care is to optimize tissue perfusion and~     oxygenation, especially in critically ill patients. The standard monitors such as blood~     pressure, heart rate and pulse oximetry do not directly reflect tissue information and can~     be misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry~     is proposed as a continuous and non-invasive tool assessing cerebral microvascular~     hemodynamics. The investigators propose this study to explore the validity of CHS via~     comparison with transcranial Doppler measurement in anesthetized surgical patients. The~     hypotheses are: 1) CHS can effectively measure cerebral microvascular hemodynamic changes~     associated with mechanical ventilation adjustment during anesthesia. 2) CHS can assess~     functional status of cerebral autoregulation that is altered by hypercapnia and inhalational~     anesthetic agent.~   "
67042|NCT02179827|"~     The aim of this study is to assess the responsiveness of the standard minimally invasive~     hemodynamic monitors used in the operating room to known changes in the intravascular volume~     status that occur during blood removal and volume replacement with three different standard~     fluids used during ANH.~   "
67043|NCT02179814|"~     Bulimia nervosa is a severe psychiatric disorder characterized by recurrent binge eating~     episodes followed by inappropriate compensatory behavior to prevent weight gain such as~     self-induced vomiting. With this project, the investigators want to investigate the role of~     the neurotransmitter dopamine in bulimia nervosa. Dopamine is reported to have an important~     influence on the neural reward system and is involved in the processing of gains and losses.~     The reward system is functionally connected to the individual perception of rewards in the~     environment. A previous study revealed that under catecholamine depletion including dopamine~     depletion women suffering from bulimia nervosa in their past reported mild bulimic symptoms~     and their reward processing became dysfunctional: their ability to use rewarding stimuli for~     task solving was diminished.~      The aim of this study is to investigate the role of reduced dopamine availability in the~     development or maintaining of bulimia nervosa and in the dysfunctional processing of~     rewarding stimuli and negative visual information. Therefore, the investigators hypothesize~     that catecholamine depletion achieved by oral administration of alpha-methyl-paratyrosine~     (AMPT) will induce mild bulimic symptoms in females suffering from bulimia nervosa in their~     past. In addition, they will reveal dysfunctions in reward and emotional processing under~     catecholamine depletion. Using functional magnetic resonance imaging, the investigators~     propose that a reduced activation of the nucleus accumbens, a neural structure of the reward~     system, will be the neural correlate of this dysfunctional reward processing. Furthermore,~     the amygdala, a neural structure that is involved in emotional processing, will show a~     higher activation under catecholamine depletion. Genetic factors additionally have an~     influence on the dopaminergic system. Therefore, the investigators hypothesize that genetic~     factors, for example the COMT val-158-met polymorphism may have an effect on the behavioral~     and neural response to catecholamine depletion. In sum, this investigation may help to~     understand which changes in reward and emotional processing may lead to a reoccurrence of~     bulimic symptoms.~      In future, the findings of this study may help to develop individual pharmacological and~     psychotherapeutical interventions to enhance the outcome of treatment.~   "
67044|NCT02179801|"~     The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is~     to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms~     in these patients should be identified at an early stage and thereby AAA-associated~     mortality be decreased.~   "
67045|NCT02179788|"~     Most new mothers in the United States will start off breastfeeding. For some mothers,~     despite following best practices, they are not able to meet their breastfeeding goals due to~     unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic~     (elevated blood sugar, but not yet diabetic). My progression of research suggests that the~     same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin~     is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small~     scale randomized trial designed to test for a trend in the hypothesis that metformin is safe~     and potentially effective in treating low milk supply in insulin resistant and pre-diabetic~     mothers.~   "
67046|NCT02179775|"~     The purpose of this study is to determine whether Quince Oxymel is effective in the~     prevention of Migraine attacks in patients with simultaneous upper gastrointestinal~     dysfunction.~   "
67049|NCT02179736|"~     This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in~     correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate~     the safety of repeat treatment of the nasolabial folds 12 months after the initial~     treatment.~   "
67050|NCT02179723|"~     This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar~     incisions are greater or equivalent to those provided by the standard therapy of~     transcutaneous sutures.~      In particular, it tests the long-term cosmetic result after 3 months, the safety and~     tolerance, as well as the practicality of treatment with Leuksan Adhesive.~      An open, randomised, controlled, prospective, single location, clinical study of women of~     ages between 18 and 60 years within the time span of March 2013 and April 2013.~   "
67051|NCT02179710|"~     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains~     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic~     saline. Programs to enhance adherence, including comprehensive behavioral interventions with~     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,~     and data capture technology offer the potential for enhancing adherence by providing~     immediate and more frequent feedback to the patient regarding his or her fidelity to the~     prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a~     systematic approach to linking treatment and feedback components to enhance adherence.~   "
67052|NCT02179697|"~     The purpose of this study is to compare surgery plus bracing versus bracing alone. Both~     groups are considered standard of care treatments. The goal of this study is to determine~     which group is a better treatment.~   "
67053|NCT02179684|"~     The purpose of this study is to investigate if an early surgical intervention on patienst~     with Bell´s Palsy has a better impact on their facial muscular function and their quality of~     life as compared to conventional therapy.~   "
67054|NCT02179671|"~     Primary objective: To assess the efficacy of various sequences of either a small molecule or~     an IMT (IMT-A) followed by a IMT-B (MEDI4736) .~   "
67055|NCT02179658|"~     The primary objective of this study is to investigate the safety and efficacy of OPT-80~     versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
67056|NCT02179645|"~     A Single Dose Study of GRC 27864 in Healthy Volunteers.~   "
67057|NCT02179632|"~     Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and~     the companies often pay large sums for consulting and advising services. Recipients of these~     payments and companies have stated that these financial relationships contribute to~     innovation in health care. However, multiple studies have also found that such payments have~     the potential to bias prescribing and treatment behaviors, and thus may lead to increases in~     health care costs.~      One way to address potential conflicts of interest in medicine is public disclosure. As part~     of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a~     national disclosure website that posts all payments from pharmaceutical, medical device, and~     biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10~     must be reported, and they will be listed by category, such as speaking engagements, meals,~     travel, and consulting services.~      The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final~     Regulations for the PPSA that the disclosure website will permit patients to make better~     informed decisions when choosing health care professionals and making treatment decisions,~     but the ways in which patients will evaluate and interpret disclosure remain unclear. One~     prominent topic in the discussion of disclosure is patient trust in health care providers~     and how transparency will affect the patient-doctor relationship—and, consequently, how the~     new law may affect physicians and hospitals.~   "
67058|NCT02179619|"~     The study is to verify that Dermalax (Deep) is not inferior to the reference device,~     Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects~     who voluntarily signed the informed consent and are judged to be eligible for this study~     will be intradermally injected both of study device and comparator device. Subjects will be~     randomized to receive injection of study device and comparator device on their each~     nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale~     (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject~     diary which will be given to subjects during the first 2 weeks after the injection. Any~     uncomfortable things and adverse events will be investigated from subject diary and follow~     up visits.~   "
67059|NCT02179606|"~     This study is to verify that Dermalax Implant Plus is not inferior to the reference device,~     Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds~   "
67060|NCT02179593|"~     A few studies state that 3-segment SARPE has the following advantages: a) higher level of~     expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster~     bone healing. The investigators hypothesize that 2-segment SARPE is as effective as~     3-segment SARPE concerning treatment and/or quality of life in daily practice.~   "
67061|NCT02179580|"~     Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially~     subsidizes domestic teaching hospitals to install clinical study centers for Chinese~     pharmacies, in order to establish the clinical study environment for Chinese pharmacies~     meeting the international regulations, to assist promoting and performing clinical studies~     in Chinese pharmacies, and then to improve the nation's health and benefits. This will~     render Chinese pharmacies competitive in the international market by employing scientific~     tests and verifications. The new project applications are respectively as follows: A~     randomized double blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in~     patients with irritable bowel syndrome The main clinical manifestations of irritable bowel~     syndrome (IBS) are chronic, recurrent abdominal pain or abdominal dyscomfortable associated~     with the changes of defecation habit, such as constipation and/or diarrhea. Clinical~     treatment of IBS includes behavioral, and drug treatment, such as anti-diarrheal agent,~     5-HT3 receptor antagonist and 5-HT4 receptor agonist, but these treatments relieve partial~     symptoms only. Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses~     XSLJZT to treat the patients who has qi deficiency, phlegm-retained fluid, nausea and~     vomiting, gastrointestinal dysharmony and producing many symptoms. These symptoms of~     mentioned-above are similar to IBS. Therefore, the purpose of the present study was to~     investigate the therapeutic effect of XSLJZT on IBS, the investigators designed a randomized~     double blind placebo control study to assess the effect of XSLJZT on IBS.~   "
67062|NCT02179567|"~     The investigators propose to study the efficacy and safety of the combination of Docetaxel~     plus Bevacizumab in a Phase II trial of elderly subjects with non-small cell lung cancer~   "
67063|NCT02179554|"~     The loss of the sense of smell, anosmia, can have profound effects on the lives of those who~     suffer from it. In our clinical practice, we have encountered several patients complaining~     of anosmia after recently undergoing surgery requiring cardiopulmonary bypass. We want to~     investigate this peculiar observation and determine if such a link exists. Thus far, there~     have been no similar studies published, and as such, no previous evidence on this matter.~     This study will help formalise and clarify these observations, empowering clinicians to~     better inform patients in the future; if cardiopulmonary bypass procedures do carry a risk~     of anosmia. This study may also give rise to further research into the matter.~   "
67064|NCT02179541|"~     Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic~     findings are subjective and not always reliable. As an objective test tympanometric~     evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate,~     in OME cases, the correlation of tympanic membrane color changes with the presence and~     viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and~     therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity~     of the fluid and evaluating color changes objectively with red-green-blue (RGB)~     measurements.~   "
67065|NCT02179528|"~     Patients with extensive-stage small cell lung cancer receive six cycles of~     chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete~     Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance~     treatment. The objective of this study is to evaluate the progression free survival,overall~     survival,objective response rate,disease control rate and safety of etoposide as maintenance~     therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the~     hypothesis of this study is maintenance therapy using etoposide may improve progression free~     survival,overall survival for selected patients. The investigators will use the peripheral~     blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a~     subgroup of patients with better response to etoposide maintenance therapy.~   "
67066|NCT02179515|"~     Background:~      - This cancer vaccine was developed to help teach the body's immune system to attack and~     destroy cancer cells. It teaches immune cells to target the Brachyury protein. This protein~     is present in some tumor cells, and it can help tumor cells spread to other parts of the~     body. Researchers want to see whether the new Brachyury protein vaccine can help treat~     people with advanced carcinomas.~      Objective:~      - To test the safety and effectiveness of giving the MVA-brachyury-TRICOM vaccine to people~     with cancer.~      Eligibility:~      - Adults ages 18 and over whose type of cancer has not responded to standard therapies who~     do not have a history of autoimmune diseases and are capable of taking care of themselves.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests. They may have a computed tomography (CT) scan, a positron~          emission tomography (PET) scan, and a brain magnetic resonance imaging (MRI) scan. They~          may have a bone scan. They will have an electrocardiogram (ECG) to test heart rhythm.~        -  Participants will have visits about every 4 weeks. They will have a physical exam and~          blood and urine tests. They will be injected with the vaccine under the skin into the~          upper thigh or around the armpits.~        -  CT scans or MRI scans will be done at visit 1, after 3 months on study, and again 3~          months later if still on the study. Another ECG will be done at their last vaccine~          visit.~        -  When participants stop the vaccine, they will return for visits until they recover from~          any side effects. They will have tests including physical exam, blood tests, scans, and~          x-rays.~        -  Participants will be asked to enroll in another study for long-term follow-up.~   "
67067|NCT02179502|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to~     healthy male subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as~     well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics)~     will be characterized compared to placebo.~      The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those~     of a liquid dosage formulation of GLPG1690.~      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with~     GLPG1690 will be explored.~   "
67068|NCT02179489|"~     Multicentric randomised trial. The goal of this clinical research study is to learn if~     hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of~     peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal~     cancer. The safety of this treatment will also be studied.~   "
67069|NCT02179476|"~     A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device~     in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful~     neural ablation in which the facet joint is confirmed as the source of pain.~   "
67070|NCT02179463|"~     RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric~     cancer, yet the best pattern of response evaluation remain unknown.~      PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.~   "
67071|NCT02179450|"~     Based on recent findings that botulinum toxin injections in the cranial muscles might reduce~     emotional processing (Havas 2011), an increasing number of popular newspaper tabloids are~     suggesting a negative effect on cognition. The underlying research articles address the~     facial feedback hypothesis. The hypothesis indicates that expressive behaviour, including~     facial mimic expressions influences the subject's brain via feedback. (Alam 2008) Other~     systemic neurological diseases, e.g of inflammatory origin, may lead to temporary bilateral~     facial nerve palsy (BF). During recovery process, the palsy usually remits completely.~      The effect of bilateral facial muscle palsy on cognition and emotional possessing has never~     been evaluated.~      The results of this pilot study might provide new information about the effect bilateral~     facial palsy on emotional processing and cognition and the facial feedback hypothesis.~      The aim of this controlled pilot study is to assess cognitive function and emotional~     processing in patients with bilateral facial palsy. In addition, differences in cognitive~     function and emotional processing in patients with different manifestations of dystonia~     should be evaluated.~      According to the facial feedback theory, paralysed mimic muscles might alter emotional~     processing. Therefore, investigators compare patients with bilateral facial muscle palsy and~     healthy controls. Investigators expect no influence of facial muscle palsy on cognitive~     functions in any of the tested groups; the investigators expect a mild impairment of~     emotional processing only in the patients group with bilateral facial muscle palsy (BEB and~     BF). In addition, the investigators expect no difference in emotional processing in patients~     with different manifestations of dystonia (BEB and CD) at remission. There might be a slight~     difference of emotional processing in patients with different manifestations of dystonia~     (BEB and CD) at time of prominent facial palsy.~   "
68876|NCT02155816|"~     The purpose of this study is to determine if supplementation with a mixture of omega 7 and 3~     fats has a favorable influence on blood inflammation and lipoprotein biomarkers in women~     with systemic inflammation compared to omega 3 and placebo.~   "
67072|NCT02179437|"~     Postoperative pain can be severe after liver resection surgery. However, postoperative pain~     management may be difficult for this group of patients. Opioidergic neurotransmission may be~     altered in cirrhotic patients and selectively increasing receptor affinity for opioids.~     Large dose of strong opioid may be required to achieve adequate pain control. However, this~     may not be possible due to the side effect of opioid and liver dysfunction after liver~     resection.~      Propofol is a commonly used anaesthetic with rapid recovery and less side effects and TIVA~     (total intravenous analgesia) with propofol is a common technique now. The reduction on~     certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.~      Recent case report proved the analgesic effect of propofol infusion. However other animal~     and clinical studies showed controversial result.~      The aim of this retrospective study is to investigate the postoperative analgesic effects~     and side effects of intraoperative TIVA with propofol in patient undergoing liver resection~     surgery at Queen Mary Hospital, Hong Kong between 2010 to 2012.~   "
67073|NCT02179424|"~     Previous research shows a significant proportion of smokers work in full-time employment.~     Given that the majority of smokers do not aware of the smoking cessation services available~     in Hong Kong, implementing smoking cessation policy in the workplaces may assist a~     considerable number of smokers to stop or reduce smoking.~      This study aims to:~        1. examine the employers' knowledge, attitudes and practices in promoting smoking~          cessation in workplace.~        2. test the effectiveness of a brief and an intensive smoking cessation interventions to~          help workers stop smoking~      In Phase I of this study, a large scale cross-sectional survey will be conducted to 3000~     corporate companies in Hong Kong. The questionnaire will examine the employers' knowledge,~     attitudes and practices in promoting smoking cessation in the workplaces.~      In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a~     smoking cessation intervention offered by the Department of Psychology, the University of~     Hong Kong. Smokers from the participating companies will be interviewed before the~     intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and~     52-week post-intervention follow-ups.~      The follow-up assessments will consist of a biochemical validation for the self-reported~     quitters who report quitting in the past 7 days via exhaled carbon monoxide and saliva~     cotinine concentration tests. Participants' smoking behaviour, knowledge on smoking and~     satisfaction of the smoking cessation services will also be evaluated.~      It is hypothesized that the smoking cessation intervention helps workers stop smoking.~     Employers' knowledge and attitudes are positively associated with the practices in promoting~     smoking cessation in workplace.~      Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group~     will be conducted after 6-month follow-up.~   "
67074|NCT02179411|"~     Autonomic nervous system contributes to the regulation of renal blood flow, affected by~     upright posture. Kidney transplantation implies sympathetic denervation. The aim of this~     study is to compare the renal vascular response in volunteers and renal graft recipients to~     an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are~     assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma~     concentrations of catecholamine before and after the head-up tilt test.~   "
67075|NCT02179398|"~     Detecting serious bacterial infections (SBI) in children presenting to the Pediatric~     Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic~     challenge. The recently described Lab-score, based on the combined determination of~     Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an~     accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess~     the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in~     children with FWS, and to prospectively determine the diagnostic characteristics of the~     Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count,~     band count and CRP).~   "
67076|NCT02179385|"~     CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle~     and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.~      Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence~     improves self treatment among uncontrolled diabetic patients.~   "
67077|NCT02179372|"~     The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin~     levels in IBD patients in clinical remission. During the study fecal calprotectin levels~     will be measured every 3 months and clinical flares will be registered.~   "
67078|NCT02179359|"~     This is a study to collect the outcomes of stem cell transplantation for patients with~     hematologic diseases other than cancer.~   "
67079|NCT02179346|"~     Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients~     with full thickness cartilage defects in the hip.~   "
67080|NCT02179333|"~     The objectives of this study are:~        -  To validate the inter-rater and intra-rater reliability of a new scale for the~          assessment of ataxia and neurologic dysfunction (STAND)~        -  To assess common constructs and correlation between STAND subscale items.~   "
67081|NCT02179320|"~     AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the~     pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome~     (MPS) patients.~   "
67082|NCT02179307|"~     The literature is not clear as to which training volume to employ during initial phases of~     resistance training programs to ensure optimal muscular adaptations. The purpose of this~     study is therefore to compare effects of strength training with low versus moderate volume~     on muscular function and hypertrophy in previously untrained, healthy individuals.~     Furthermore, the investigators will relate individual variation in responses to proxy~     markers of individual training state, such as baseline muscular function and muscle fiber~     type.~      The study will include 25 women and 25 men and will consist of a 12-week resistance training~     protocol. Each study participant will act as their own control, performing both the low-~     (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or~     non-dominant leg, in a stratified and randomized fashion.~      Primary outcome measures are thigh muscle cross section area and unilateral knee extension~     strength. Additionally, muscle fiber type composition will be evaluated as well as~     additional parameters of muscular function.~      The primary hypothesis is that low-volume protocols will be beneficial for individuals with~     glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more~     aerobic phenotypes.~   "
67106|NCT02178982|"~     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically~     diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main~     causes of death in patients. There is no unified treatment process for ARDS currently and~     the treatment measures are not yet standardized, so the standardization of ARDS treatment~     processes is needed to reduce mortality in patients. Following the evidence-based medicine~     principles and six-step treatment standards of ARDS, this study uses the method of~     multi-center randomized controlled clinical trials to evaluate the standardized treatment~     process of ARDS, which provides the basis for the standardized treatment of ARDS.~   "
68877|NCT02155803|"~     ACTHAR Gel has activity in sarcoidosis associated hypercalciuria and calcium dysregulation.~   "
67083|NCT02179294|"~     Childbirth can be an extremely painful and the provision of pain relief during labour is a~     vital component of a positive maternal experience. The majority of women who deliver in~     modern obstetric units choose a pharmacological method of pain relief, including Entonox,~     the injection of opioids or epidural placement. The commonest opioid used in labour is~     pethidine administered by intramuscular (im) injection. The effectiveness of pain relief~     provided by pethidine has long been challenged. Its shortcomings are more serious when set~     against known side effects including maternal sedation, nausea and potential transfer across~     the placenta to the foetus. More than a third of women who receive pethidine subsequently~     require an epidural due to inadequate pain relief. Epidurals provide highly effective pain~     relief, but increase the risk of a forceps or suction delivery resulting in prolonged~     hospital stay. Therefore, there is a clear need for a safe, effective, easy to administer~     analgesic alternative.~   "
67084|NCT02179281|"~     The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed~     system significantly reduces hypoglycemic excursions and thus provide proactive protection~     to the user.~   "
67085|NCT02179268|"~     The aim of this five arm randomized trial was thus to compare selective serotonin reuptake~     inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a~     nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the~     primary endpoint being bone mineral density, and secondary endpoints being bone turnover~     markers.~   "
67086|NCT02179255|"~     Synthetic human growth hormone (HGH) has been available for more than a decade for specific~     indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under~     off-label use) for improving ovarian function have shown that a combination of traditional~     gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing~     pregnancy rates, but not increasing egg production after IVF in women with documented~     diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at~     least 6 weeks prior to IVF start, the investigators will be able to increase production of~     oocytes and further improve pregnancy chances. This hypothesis is based on prior~     observations of effects of growth hormone on small antral follicles and the fact that prior~     studies utilized HGH principally only during ovulation induction itself.~      The investigators plan to recruit 30 women (15 in each group) to an open label randomized~     controlled trial of HGH for augmentation of ovarian response among women with documented DOR~     and poor prior response to ovulation induction.~      Eligible participants will be women < 45 years with documented history of prior retrieval of~     2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with~     dehydroepiandrosterone (DHEA).~      Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before~     start of their treatment cycle. Cost of treatment with HGH will be a cost to the~     participating patient. HGH will cost the patient approximately $800 per week of treatment.~     Patients who are randomized to the non-HGH treated group, and do not conceive, will in the~     following cycle be offered HGH supplementation outside of this clinical trial. This~     subsequent cycle will not be part of the study dataset and patients will also be responsible~     for the cost of HGH.~      Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to~     detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit~     15 patients in each group to allow for possible dropouts.~   "
67087|NCT02179242|"~     The aim of the investigators' project is to determine if patients admitted with a primary~     diagnosis of heart failure to Sanford Health facilities in regional southeastern South~     Dakota demonstrate benefits in improvement in functional capacity, quality of life, and a~     reduction in hospital readmission rates from a cardiac rehab program immediately following a~     discharge for an acute decompensated heart failure diagnosis related inpatient~     hospitalization encounter. The investigators hypothesize that those that receive cardiac~     rehab will have improved quality of life and reduced readmission rates at 30 and 90 days.~   "
67088|NCT02179229|"~     The purpose of this study is to establish whether a short treatment with the synbiotic~     combination Probinul neutro® may decrease the plasma concentration of the uremic toxin~     p-cresol in patients bearing a kidney allograft. The effect of this treatment on plasma~     levels of immunosuppressant drugs will be evaluated as well.~   "
67089|NCT02179216|"~     Primary objective: To compare the decrease in systolic blood pressure between hydration and~     venous contention when switching to a standing position. Hypothesis in that hydration is~     better than venous contention.~      Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure~     during the passage standing in elderly patients with orthostatic hypotension.~      Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1~     and / or 3 min~   "
67090|NCT02179203|"~     Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler~     signals changes during cardiac resynchronization procedure. As the LDS represent the various~     mechanical events of cardiac origin it is assumed that they may reflect the relative timing~     between contraction of the ventricles and atria and thus serve for effective synchronization~     of these activities.~      Aim of the study:~      The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves'~     characteristics will mimic the changes in echocardiographic parameters designed to assess~     diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.~   "
67091|NCT02179190|"~     Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an~     adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms~     in the middle cerebral and basilar arteries.~   "
67092|NCT02179177|"~     In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a~     significant decrease in morbidity and as a result, decrease healthcare utilization and~     costs. This study attempts to critically avoid admissions by reducing daily pain scores and~     pain crisis as an outpatient by use of a novel oral anticoagulant.~   "
67093|NCT02179151|"~     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese~     adolescent and adult subjects with Prader-Willi Syndrome.~   "
67094|NCT02179138|"~     To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir~     (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural~     KwaZulu-Natal, South Africa.~   "
67107|NCT02178969|"~     The purpose of this study is to better understand disease extent and to identify appropriate~     methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and~     qualitative manner.~   "
67108|NCT02178956|"~     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,~     in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as~     second line treatment for gastric and gastroesophageal junction cancer after prior first~     line platinum and fluoropyrimidine based chemotherapy.~   "
67109|NCT02178943|"~     Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA~     in association with the measurement of AlloMap, a non-invasive gene expression test to aid~     in heart transplant management.~   "
67095|NCT02179125|"~     Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a~     bronchoscopic lung volume reduction treatment designed to compress the areas of lung~     parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and~     effective in previous studies. However, patient-based outcomes besides quality of life~     questionnaires are hardly measured after intervention treatments for COPD. Furthermore, the~     exact underlying physiological mechanism of the LVR-coil treatment is unknown. Another~     aspect of the treatment which we to date do not fully understand is which group of patients~     benefit of the treatment and which group of patients do not, this knowing that the responder~     rate is already about 60%.~      Objective: The objectives of the study are to gain more knowledge on 1) the effect of the~     LVRC treatment on patient-based outcomes like physical activity, 2) the underlying~     physiological mechanism of the treatment, 3) the predictors of response to the treatment at~     baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung~     compliance.~      Study design: This study is a non-randomised open label multi-center intervention study.~      Study population: The study population exists of adult patients with severe emphysema with~     no other treatment options left besides surgical procedures.~      Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.~      Main study parameters/endpoints: The main study endpoint is the change in physical activity~     between baseline and 3 months follow-up after the second treatment. The secondary endpoints~     are the changes between baseline and 3 months follow-up after the second treatment in:~     patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung~     volumes, lung compliance, diaphragm function, lung perfusion, systemic inflammation and~     small airways function.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the~     risks associated with the LVRC system are largely attributable to the bronchoscopic~     procedure itself rather than to the device per se. Therefore, it appears that the LVRC~     device itself does not appreciably increase the risk of serious adverse events beyond the~     risk of undergoing a bronchoscopy procedure or simply having emphysema. Currently, this~     treatment is not commercially available in the Netherlands and study participants will have~     to visit the hospital multiple times. Previous studies have shown that the treatment has~     beneficial effect for the patient, however not all patients respond. Part of this new study~     is to try to identify which group of patients respond to the treatment and which patients do~     not. Therefore, it is possible that a patient will not receive any benefits from the~     treatment.~   "
67096|NCT02179112|"~     A multicentre, international evaluation of emergency abdominal surgery to establish surgical~     outcomes and identify common, modifiable best practice processes.~   "
67097|NCT02179099|"~     This is a single arm pilot study evaluating the feasibility and preliminary safety of a~     single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for~     symptomatic improvement in overactive bladder patients.~   "
67098|NCT02179086|"~     This randomized phase II trial studies how well dose-escalated photon intensity-modulated~     radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose~     radiation therapy when given with temozolomide in patients with newly diagnosed~     glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor may kill more tumor cells and cause less damage to normal~     tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation~     therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation~     therapy is more effective than standard-dose radiation therapy with temozolomide in treating~     glioblastoma.~   "
67099|NCT02179073|"~     Bladder management has a major impact on the quality of life in patients with neurogenic~     bladder dysfunction. This a prospective investigation of the effects of the method for~     bladder evacuation on the health-related quality of life in patients with neurogenic bladder~     dysfunction. The changes in health-related quality of life over time (longitudinal~     investigation) and the differences between the different methods for bladder evacuation will~     be investigated. Patients will be given a standardized and validated questionnaire annually~     for 10 years.~   "
67100|NCT02179060|"~     Therapeutic hypothermia improves the neurologically-intact survival rates in those patients~     resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible~     might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted~     magnetic resonance imaging have recently shown to be able to identify early ischemia-related~     changes within the brain three days after cardiac arrest, among sudden cardiac arrest~     patients cooled in hospital. The physical changes seen within the brain may be able to~     distinguish survivors at very early phase.~      This study aims to assess early ischemia-related changes of the brain seen in MRI~     approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the~     groups of patients treated with early intra-arrest cooling with the RhinoChill device and in~     hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital~     hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital~     hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint~     is the presence and pattern of white matter and gray matter degeneration and volumetric~     changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and~     secondary endpoints are total survival at 90 days, and time to reach a target temperature~     (≤36/33 Celsius).~   "
67101|NCT02179047|"~     Through the literature review , we pick out a series of forward-looking biological~     indicators as follows :~        1. NGAL~        2. Cystatin C:~        3. Galectin-3:~        4. Copeptin:~        5. MR-Pro ANP:~        6. sST2:~   "
67102|NCT02179034|"~     This study is to examine if inhaled doses of menthol that produce low and high cooling~     effects change the appeal of e-cigarettes containing low and high doses of nicotine in~     adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when~     compared with menthol or nicotine alone, will result in greater increase in liking of an~     e-cigarette and greater reduction in nicotine withdrawal.~   "
67103|NCT02179021|"~     The purpose of this study is to investigate, if the haemostasis is impaired in cardiac~     arrest patients during therapeutic hypothermia compared with normothermia.~   "
67104|NCT02179008|"~     The purpose of this study is to investigate the safety and efficacy of five concentrations~     of DE-117 ophthalmic solution.~   "
67105|NCT02178995|"~     Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties~     associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008).~     Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties~     in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer,~     2012). We seek to evaluate the potential efficacy and safety of this medication in treating~     attention deficits, as well as other cognitive difficulties, experienced by adult patients~     with epilepsy.~      To our knowledge, there are currently very few studies which explicitly examine the impact~     of MPH on measureable attention deficits and other cognitive deficits in adult patients with~     epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in~     addition to other specific measureable cognitive functions, in patients with cognitive~     complaints and epilepsy, and contribute to a growing body of evidence which supports the~     safety of methylphenidate's use for attention deficits in patients with epilepsy. As other~     effective treatments for attention and other cognitive difficulties in patients with~     epilepsy are not currently available, MPH could represent an important option in the~     treatment of such patients.~   "
67110|NCT02178930|"~     The purpose of this study is to improve the health status of people living with HIV in~     Australia. The overall goal is to rigorously evaluate the impact of interactive health plans~     and self-management support on chronic condition outcomes in people with HIV.~      The specific aims are to:~      Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive~     health plans and self-management support on coronary heart disease risk and other chronic~     condition outcomes in people living with HIV.~      Aim 2: Evaluate patient and health care provider experiences and acceptability of~     interactive health plans and self-management support.~      Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.~   "
67111|NCT02178917|"~     Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.~     SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP).~     This pain typically develops several months after the injury. In 30-40% of SCI patients,~     severe CNP affects their everyday living including sleep and mood. Many patients give up~     work, not because of the injury, but because of pain. Medical treatment of CNP is moderately~     effective and costly, both to the patient and to the health care system.~      In previous research, characteristic 'signatures' of brain waves that are probably related~     to CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback~     was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was~     used to record patients' brain waves and these were shown to patients on a computer screen~     in a simple graphical form (e.g. bars). Patients were trained to change their brain activity~     at will and, as a consequence, their pain was reduced. Patients who had suffered from CNP~     for years received up to 40 neurofeedback treatment sessions, reducing their pain for~     several days after each session.~      The primary aim of this study is to apply neurofeedback therapy to a larger number of~     recently injured patients, who are still in a hospital. It is hypothesised that~     neurofeedback treatment will be more effective in people who have suffered from CNP for a~     shorter period of time.~      The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in~     recently injured patients with no chronic pain, knowing that a certain number of patients~     will develop CNP within weeks or months. These patients will be followed up for a year and~     the EEGs of patients who develop CNP will be compared with those who do not.~   "
67112|NCT02178904|"~     The purpose of this study is determine the diagnostic performance of dual energy computed~     tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary~     stenosis, as compared to a direct measurement of fraction flow reserve during cardiac~     catheterization as a reference standard.~      The overall objective of the present study is to determine the diagnostic performance of~     dual energy computed tomography perfusion for non-invasive assessment of the hemodynamic~     significance of coronary stenosis, as compared to direct measurement of fraction flow~     reserve during cardiac catheterization as a reference standard.~   "
67113|NCT02178891|"~     An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone~     anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.~   "
67114|NCT02178878|"~     The purpose of this study is to try to understand why the experience of labor differs among~     women. The investigators want to understand why some women have longer or shorter labors and~     why the amount of pain women experience is different. The investigators hope to be able to~     consider women more individually in terms of their pain and progress of labor.~   "
67115|NCT02178865|"~     The purpose of this study is to assess the accuracy of predicting the normal or carrier~     status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a~     balanced translocation.~   "
67116|NCT02178852|"~     Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed,~     neuroimaging studies show changes in neural activity in specific brain regions such as the~     amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical~     connections established with the trigeminal nerve have been associated with the mechanism~     called bottom-up neuromodulation. According to this hypothesis, the spread of electrical~     stimulation follows a path from the peripheral nerves towards the brain stem was then~     advertise for cortical and subcortical regions. Connections to structures involved in the~     reward system as the amygdala and hippocampus could theoretically modulate dysfunctional~     brain activity in these regions, which may induce favorable clinical effects.~   "
67117|NCT02178839|"~     The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on~     Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in~     Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.~   "
67118|NCT02178826|"~     Nocturnal enuresis (NE) is the involuntary loss of urine that occurs only at night in~     children aged 5 years or more.~      NE is a common problem, affecting about 10% of school children. The prevalence declines with~     each year of maturity but for some it persists in to adolescents and early adulthood. It can~     lead to bad self-confidence and low self-esteem, which can have psychosocial consequences.~      NE is a multifactorial condition. Three central factors have been identified:~      A) Many bedwetting children produce large amounts of urine at night due to a deficiency of~     the antidiuretic hormone vasopressin.~      B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all~     children are deep sleepers with high arousal thresholds. They simply don't wake up when the~     bladder is full or when it contracts.~      There are two well established and evidence based treatments today: the bed-wetting alarm~     and the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets~     the bed, which conditions the child to wake up or inhibit bladder emptying. This method is~     curative for about half of the patients who try this, but relapse occurs. Desmopressin is a~     synthetic analog of arginine vasopressin and works by decreasing the urine volume at night.~     About half of the patients become dry with this medication but only as long as they take the~     medicine. To day, at least 25% of all children with NE do not respond to any of the above~     treatment.~      Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a~     narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is~     activated twice every day for 10-14 days. The procedure is neither painful nor harmful and~     is not very visible at all.~      There are a few reports about children who have become dry after RME treatment. None of them~     have been randomised or placebo controlled but indicates that quite a few children do become~     dry after this treatment. A recently carried out study in Sweden show that half of the~     children became dry after RME treatment. These children were all classed as therapy~     resistant and had already tried the alarm and medication without success.~      The reports are intriguing, but invite the question why a brace would help cure NE? It is~     likely that sleep and respiration is involved. This study will investigate these children's~     sleep during the treatment. The trial is a randomised, placebo controlled trial.~   "
67161|NCT02178267|"~     In this study, the investigators investigated the effect of probiotic use on colonization of~     resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the~     use of probiotics in preterm neonates in neonatal intensive care units expect to prevent~     colonization by resistant microorganisms.~   "
67119|NCT02178813|"~     The purpose of this study is to evaluate the safety and tolerability of high-dose~     minocycline in the patient population undergoing carotid revascularization procedures,~     namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of~     safety will facilitate proceeding to a phase II trial.~      During this trial, patients undergoing carotid revascularization procedures will receive~     high doses of minocycline with the following schedule (based on previous trials):~        -  Day prior to procedure: 800mg orally (p.o), 700mg p.o.~        -  Day of procedure: 600mg intravenously( i.v.), 500mg p.o.~        -  Day after procedure: 400mg p.o., 400mg p.o.~      The levels of the drug in the plasma, standard blood tests (complete blood count,~     creatinine, liver function tests) as well as markers of neuronal injury (Neuron specific~     enolase, protein- S100b) and inflammation (C-reactive protein) will also be monitored. The~     patients will be monitored closely for the development of side effects from minocycline.~      MRI imaging will be used to follow the development of small strokes as a result of the~     revascularization procedures and their resolution. The patients of this study, all receiving~     peri-operative minocycline, will be compared with historical controls with regards to~     development of small strokes and persistent of these strokes on subsequent MRI imaging.~   "
67120|NCT02178800|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the~     body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in~     healthy, HIV-uninfected adults. Researchers will evaluate the use of this medicine for both~     the prevention and treatment of HIV infection.~   "
67121|NCT02178787|"~     Cerebral autoregulation (CA) is a complex mechanism that serves the essential and vital~     purpose of controlling cerebral blood flow and metabolism. A stable and optimal brain blood~     flow is imperative for normal brain function. Diabetes Mellitus (DM ) is associated with~     microvascular disease that alters CA and also with autonomic failure that may lead to~     orthostatic hypotension (OH). These conditions may lead to decreased brain blood flow in~     upright position. This observational study will compare two technologies that evaluate brain~     blood flow during standing up and other maneuvers in people with and without type 2~     diabetes. These technologies are transcranial Doppler and UTLight technology (CerOx). This~     study will determine the safety and feasibility of CerOx technology for continuous~     monitoring of cerebral blood flow.~   "
67122|NCT02178774|"~     Hypotension after spinal anesthesia for cesarean section is one of the most common~     perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the~     associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower~     extremities and an increase in venous capacitance. Hypotension is a distress for both~     anesthesiologists and obstetricians as it endangers parturient's hemodynamics and~     compromises the uteroplacental blood flow. In clinical practice, there are several ways to~     treat hypotension after spinal anesthesia such as preloading with intravenous fluids and~     administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the~     well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the~     anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia~     would correlate with the perfusion of the lower extremities. To measure the perfusion of the~     lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared~     spectroscopy.~   "
67123|NCT02178761|"~     Erectile dysfunction is highly prevalent as men grow older. Among the various causes of~     erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very~     important role. The investigators have recently developed the first imaging analytical~     algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT)~     angiography to delineate the whole arterial system supplying the penis. To establish a~     comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile~     dysfunction, the investigators therefore design this series of studies by including experts~     from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes~     the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial~     lesions in coronary artery disease patients with and without erectile dysfunction/lower~     urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial~     lesions in patients with vascular risk factors and with or without erectile~     dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty~     (with various interventional strategies/instruments) for patients with erectile~     dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4)~     efficacy and safety of comprehensive pelvic angioplasty (with various interventional~     strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive~     arterial disease: a randomized controlled trial.~   "
67124|NCT02178748|"~     Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects~     humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality~     and morbidity; development of an effective vaccine is a global health priority.~      Over a billion people worldwide are infected with one or more helminths. Helminths are~     parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that~     helminth infection may affect a person's response to a vaccine. In this trial the~     investigators hope to investigate whether Schistosoma mansoni infection affects adolescents'~     responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group~     for an effective TB vaccine.~   "
67125|NCT02178735|"~     To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh~     surgeries.~   "
67126|NCT02178722|"~     The purpose of this study is to assess the safety, tolerability, and efficacy when combining~     MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2~     phases, Phase 1 and Phase 2.~   "
67127|NCT02178709|"~     The primary objective of this study is to evaluate the rate of pathologic complete response~     to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue~     collection component.~   "
67162|NCT02178254|"~     The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single~     doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug,~     Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to~     dosing on Day 1 of Period 1 prior to study screening.~   "
67713|NCT02171026|"~     Investigation of the bioavailability, safety and tolerability of dabigatran with and without~     concomitant administration of amiodarone and the bioavailability of amiodarone and~     desethylamiodarone after administration of a single dose of amiodarone with and without~     dabigatran~   "
67128|NCT02178696|"~     Major depression is a highly prevalent, frequently debilitating illness that too often fails~     to respond to currently available treatments such as antidepressant medication. Furthermore,~     randomized controlled trials of antidepressants consistently demonstrate large placebo~     effects. The investigators hypothesize that individual differences in the function of key~     brain circuits underlie the observed variability in clinical responses to both placebo and~     antidepressant medication. This study will test this hypothesis by recruiting~     treatment-seeking volunteers with major depression, with or without comorbid nicotine~     dependence. Volunteers will participate in positron emission tomography (PET) and functional~     magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they~     will receive both placebo and antidepressant medication. A major goal of the study is to~     improve prediction of individual clinical responses in future treatment trials in which~     brain imaging may be unavailable, and to study the mechanisms of antidepressant response in~     Major Depression.~   "
67129|NCT02178683|"~     This protocol will evaluate Tacrolimus and MMF after conditioning with fludarabine and~     low-dose TBI in patients who are not candidates for conventional allografting. A novel~     approach to immunosuppression will be tested incorporating an early but extended taper of~     Tacrolimus starting on day +80 or in the case of relapse. The goal is to induce early~     immunity and GVT effects without compromising GVHD control. The anti-metabolite MMF will be~     re-introduced on day +100 to try and induce tolerance and block chronic GVHD during the~     taper of the Tacrolimus. DLI may be given in the presence of disease progression but not for~     mixed chimerism as in previous protocols.~   "
67130|NCT02178670|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
67131|NCT02178657|"~     This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear~     cells in acute ischemic stroke patients is safe and improves neurological outcomes.~   "
67132|NCT02178644|"~     This pilot study focuses on KD018 and will investigate the effect of this agent on reducing~     the Gastrointestinal (GI) toxicity associated with combined modality therapy of~     locally-advanced rectal cancer.~   "
67133|NCT02178631|"~     Online self-help is an innovative way of providing self-help. The investigators want to~     study the effect of an interactive online self-help-program (Deprexis) in the treatment of~     severe depressive symptoms. Participants will be randomised to either twelve weeks of~     online-self help or a waiting-list control. Symptoms of depression and other aspects will be~     assessed over a six months period. The investigators hypothesise that online self-help is~     superior to the control condition in alleviating depressive symptoms and preventing full~     blown depression.~   "
67134|NCT02178618|"~     Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been~     used as a principle palliative method of distal biliary obstruction in patients with~     pancreaticobiliary cancers. With potentially curative surgical resection being impossible,~     the maintenance of successful biliary drainage through patent stent has been regarded as the~     key to improve the quality of life and survival of patient, because it could prevent biliary~     infection or liver failure, and give patients opportunities for anti-cancer chemotherapy~     and/or radiotherapy.~      Although SEMSs have been reported to be superior to large bore plastic stents in terms of~     stent patency, they still have some controversial issues to resolve in relation to stent~     dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to~     overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant~     higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not~     show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs,~     despite some clinical results of randomized trials favor to covered SEMSs.~      From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting~     results have been produced. It was initially assumed that covered SEMSs could cause the~     higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic~     duct and cystic duct by covering materials. However, no significant difference was found~     with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered~     SEMSs in several randomized trials and meta-analysis.~      The aim of the current study is to compare the cumulative stent patency of partially covered~     and uncovered SEMS as a primary objective, and investigate overall patient survival, stent~     dysfunction-free patient survival, and incidence of adverse events including stent~     dysfunction as secondary objectives.~   "
67135|NCT02178605|"~     This prospective study will investigate the use of recombinant human bone morphogenetic~     protein (rhBMP-2) in the current surgical standard of care for cervical spine pathology.~     Specifically, the outcomes of three forms of cervical fusion will be investigated:~        1. Anterior cervical fusion with rhBMP-2, allograft corticocancellous bone as an interbody~          device, and anterior cervical plate fixation.~        2. Posterior cervical fusion with rhBMP-2, local bone graft, with or without posterior~          screw fixation.~        3. A combination of the previous two approaches: a combined anterior-posterior cervical~          fusion with rhBMP-2.~   "
67136|NCT02178592|"~     HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is~     the most common cause of death in patients with HIV worldwide. Rifamycins (such as~     rifampicin [RIF]) are an important component of TB therapy because of their unique activity.~     The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase~     inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that~     can lead to reduced concentrations of these agents with risk of treatment failure or~     resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does~     not present the same significant drug interactions with RIF. EFV-based HIV treatment was~     tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that~     their co-administration can be used safely and effectively. However, the side effect profile~     of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment~     toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer~     an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug~     interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG~     at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG~     concentrations similar to those of DTG 50 mg given once daily alone, which is the~     recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily~     may represent a new treatment option for TB-infected patients who require concurrent~     treatment for HIV infection. This is a Phase III b, randomized, open-label study describing~     the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected~     patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV)~     ART-containing regimens through 48 weeks. A total of approximately 125 subjects will be~     randomly assigned in a 3:2 ratio to DTG (approximately 75 subjects) and EFV (approximately~     50 subjects), respectively. This study will include a Screening Period, a Randomized Phase~     (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During~     the DTG OLE, subjects will be supplied with DTG until it is locally approved and~     commercially available, the subject no longer derives clinical benefit, or the subject meets~     a protocol-defined reason for discontinuation, which ever comes first.~   "
67137|NCT02178579|"~     Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac~     toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart~     disease. While the presence of cardiac events may be a class effect of proteasome~     inhibitors, the effect may be more profound with the irreversible inhibition of carfilzomib~     compared with reversible inhibition with bortezomib. Data available from currently published~     clinical trials may be inadequate to fully understand the incidence and severity of cardiac~     injury in patients treated with proteasome inhibitors because the trials were not designed~     to fully assess cardiac events. The purpose of this study is to better define and understand~     potential cardiac toxicity and begin to understand optimal management strategies.~   "
67138|NCT02178566|"~     The investigators' hypothesis is that pretreating patients with COPD with inhaled~     treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise~     tolerance during sessions. This in turn will lead to an increased response to pulmonary~     rehabilitation, resulting in improved exercise tolerance and quality of life.~   "
67139|NCT02178553|"~     In this study we will study to see if a single set of unilateral intercostal nerve blocks~     provides pain control as effectively as a continuous thoracic epidural, and will a lower~     incidence of side effects. Although the anesthesiologists involved in providing care for~     patients having thoracotomy incisions at SMH are experts at placing thoracic epidural~     catheters, this study will attempt to show that a less technically challenging procedure~     done by surgeons intraoperatively can provide comparable pain relief.~   "
67140|NCT02178540|"~     The purpose of this actual use human factors (HF) study is to validate the approved US TOBI~     Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates~     the information necessary to achieve safe and effective use of the Podhaler device.~   "
67141|NCT02178527|"~     This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of~     a multifaceted podiatry intervention designed to reduce falls in care homes. The~     investigators hypothesise that the intervention will reduce the high falls rates present in~     care homes for older people, compared to usual care.~      The results will inform the sample size calculation for a full-scale definitive RCT~   "
67142|NCT02178514|"~     Our main research question is: Do infants fed with BabyNes Nutrition System grow in~     agreement with the WHO reference?~      Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic~     profile closer to breastfed infants?~      In order to answer both questions an observational trial will be carried out for 12 months~     in order to measure weight and to calculate the weight for age z-scores according to the WHO~     reference.~      A breastfeeding group will be used as reference for the metabolic parameters measured in~     blood of infants from Chinese background.~      The effect of the Babynes formulas will be compared to the metabolic values obtained from~     this breast-feeding reference group.~   "
67143|NCT02178501|"~     The major source of mortality and morbidity of diabetic patients is cardiovascular disease~     (CVD). Moreover, in CVD patients the presence of diabetes is associated with the increased~     risk of major adverse cardiac events as compared to patients without diabetes. The~     pathophysiology of macrovascular complications in T2D is not fully understood and involves:~     1/ induction of oxidative stress, 2/ the formation of advanced glycation end products, 3/~     activation of blood coagulation and platelet aggregation, 4/ increased inflammation, 5/~     altered secretion of adipokines in obese subjects and 6/ endothelial dysfunction. All those~     mechanisms in T2D patients could potentially be a subject of new therapeutic interventions.~      A therapy that continues to show promise in T2D patients with CVD is supplementation with~     omega-3 polyunsaturated fatty acids (PUFA). Clinical studies have indicated that omega-3~     PUFA decrease the risk of major cardiovascular events, although the mechanism of action is~     not completely understood. Moreover, there were no trials exploring the mechanisms and~     outcomes of omega-3 treatment in T2D patients with CVD. Despite that fact, Polish Diabetes~     Association guidelines recommend the use of omega-3 PUFA in patients with diabetes in the~     prevention of macrovascular complications. Moreover, it is unclear whether the benefits of~     modifying the pathophysiological processes during supplementation with omega-3 PUFA occur~     only in patients with their deficiency or in all patients with type 2 diabetes.~      Potential benefits of omega-3 PUFA in such patients are: 1/ decreased oxidative stress, 2/~     decreased platelet aggregation and reduction of hypercoagulable state, 3/ anti-inflammatory~     effects, 4/ improvement in endothelial function. All those effects were explored previously~     with inconsistent findings. There is very limited information from clinical studies on the~     mechanisms and benefits of omega-3 PUFA in T2D patients with CVD.~      The objective of the current study is to evaluate the effects of omega-3 PUFA administered~     on top of optimal therapy of atherosclerotic vascular disease and T2D on endothelial~     function, platelet aggregation and thrombotic, inflammatory and oxidative stress biomarkers.~   "
67144|NCT02178488|"~     The purpose of this study is to treat persistent MRSA carriers with vitamin D~     supplementation during a 12 month to see if the number of MRSA positive patients can be~     reduced.~   "
67145|NCT02178475|"~     Prospective observational study of febrile neutropenia (FN) and pegfilgrastim primary~     prophylaxis in breast cancer and non-Hodgkin's lymphoma patients receiving high (>20%)~     FN-risk chemotherapy~   "
67146|NCT02178462|"~     A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for~     gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles~     (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed~     by multivariate statistical analyses. However, further studies to assess whether this~     biomarker demonstrates the same performance characteristics in non-Japanese populations for~     cancer is yet to be determined.~   "
67147|NCT02178449|"~     The main aim of the study is to investigate the proven effect of dexamethsone on the~     duration of the interscalene block. The investigators try to define optimal dose and volume~     for ropivacaine, when used together with dexamethsone. The current literature uses often~     very high volumes of ropivacain when used together with dexamethasone. The investigators try~     to research the effect of using dexamethsone together with low volume, high concentration~     ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone~     has an positive effect on the pain free after used together with ropivacaine at the scalene~     block.~   "
67148|NCT02178436|"~     This partially randomized phase Ib/II trial studies the side effects and best dose of~     selinexor when given together with gemcitabine hydrochloride and paclitaxel~     albumin-stabilized nanoparticle formulation and to see how well they work in treating~     patients with pancreatic cancer that has spread to other parts of the body. Drugs used in~     chemotherapy, such as selinexor, gemcitabine hydrochloride and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
67149|NCT02178423|"~     After the placement of a central venous catheter in children, a routine chest X-ray will be~     performed in order to examine the correct position of the catheter. In this feasibility~     study the investigators intend to evaluate whether the ultrasound is as sufficient as the~     chest X-ray to verify the correct position of the central venous catheter in children with~     the purpose to prevent radiation on children in the future.~   "
67150|NCT02178410|"~     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,875~     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3~     (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in individuals who do not have a prior history of these~     illnesses.The purpose of this ancillary study is to ascertain and adjudicate atrial~     fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or~     vitamin D supplementation influence atrial fibrillation risk in the general population. We~     also plan to examine how these agents might impact intermediate phenotypes for heart rhythm~     disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death~     and whether baseline blood levels and/or race modify treatment effects.~   "
67151|NCT02178397|"~     The current first line treatment of patients with EGFR activating mutation lung cancer is~     EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of~     response rate and progression-free survival. However, an acquired resistance occurs almost~     constantly. The second-line treatment includes platinum-based chemotherapy in the absence of~     contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.~      However, a rebound phenomenon of the disease was described in patients who discontinued EGFR~     TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any~     withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI~     acquired resistance.~      It seems therefore useful to conduct a study to better define the therapeutic strategy to~     adopt in patients developing an acquired resistance after having received EGFR TKIs as first~     line treatment.~   "
67152|NCT02178384|"~     The two structures that support a mandibular distal extension removable partial denture~     differ markedly in their visco-elastic response to loading. The difference between the~     resilience of the residual ridge tissues and the teeth permitted by the periodontal ligament~     presents a disparity of support that is in contrast to the uniform support accorded a~     tooth-supported removable partial denture. Hence the denture tends to rotate about its most~     distal abutments, inducing heavy torsional stresses on alveolar ridges.~      Many methods have been used to control this movement, some of them:~        1. Implant support on distal extension removable.~        2. Stress breakers provide a mean of interposing a flexible connection between the~          tooth-borne retainer portion of removable partial denture and its distally extended~          tissue-borne segment.~        3. Altered-cast technique.~        4. Design development by using mesial indirect retainers rather than distal ones.~      The purpose of this study is: (1) to compare bone absorption around abutment teeth nearby~     the free saddle; (2) denture displacement and pressure on the soft tissue under the denture~     base of distal extension RPD (Removable Partial Denture) (3) cellular changes in the soft~     tissue under the denture base of distal extension RPD.~   "
67153|NCT02178371|"~     The purpose of this study is to assess the functionality of the affected upper limb in~     infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.~   "
67154|NCT02178358|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY2157299 in participants with hepatocellular carcinoma.~   "
67155|NCT02178345|"~     Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of~     the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses~     faster imaging. It also includes a contrast material that is given by vein. This makes~     specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the~     motion of water in the tumor.~      Perfusion and diffusion MRI give extra information which is not available with the regular~     MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the~     current standard of care. The purpose of this study is to see if new MRI methods can give us~     more information about the tumor.~   "
67156|NCT02178332|"~     The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole~     school programme is effective in improving children's socio-emotional skills and mental~     health and socio-emotional skills.~      All Finnish elementary schools and their classes in 1-3 grades were invited to participate~     in the study. The schools were randomly allocated to receive either Yhteispeli programme or~     two lectures~   "
67157|NCT02178319|"~     Many patients with portal hypertension require surgical treatment each year,and Hassab's~     operation, or esophagogastric devascularization and splenectomy, is an elective procedure.~     In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used~     to treat portal hypertension. However, the potential benefits remain to be demonstrated in~     the context of a randomized trial. In this study, 120 patients will randomize equally~     receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion~     criteria included: platelet count < 50×109/ml, esophageal and gastric varices revealed,~     agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and~     infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns~     of reflux on duplex ultrasound examination, complications, platelet and liver function~     variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and~     ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study~     was proved by the ethical committee of second hospital of Xi'an jiaotong university.~   "
67158|NCT02178306|"~     To evaluate the safety and efficacy, in particular with regard to renal function of~     telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to~     endstage renal impairment after 12 weeks of treatment~   "
67159|NCT02178293|"~     A study to in order to verify any differences between the 2 treatment groups in terms of~     duration of analgesic effects after the first drug intake and time to remission of symptoms~     and signs of pharyngitis~   "
67160|NCT02178280|"~     Hilar cholangiocarcinoma is a highly malignant tumor. Surgical resection or simple liver~     transplantation leads to poor prognosis accompanied by high recurrence rate and low survival~     rate. The newly proposed neoadjuvant therapy with liver transplantation strategy shows~     promising clinical application, which once reported 5-year survival rate 82%. However,~     transplantation centers conducting this kind of research are limited due to its complexity~     and long-term. The investigators would like to conduct a clinical trial for only~     unresectable hilar cholangiocarcinoma patients who should take neoadjuvant brachytherapy and~     chemoradiotherapy followed by orthotopic liver transplantation.~   "
67163|NCT02178241|"~     This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in~     treating patients with bladder cancer that has spread to other places in the body or cannot~     be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and~     eribulin mesylate, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
67164|NCT02178228|"~     The purpose of this study is to identify the cause of leaks that sometimes occur after a~     section of the bowel is removed and reconnected. Certain staplers from the operating room~     will be collected and sent to a third party (ECRI Institute) to be examined for defects. The~     patient's charts will be analyzed for medical issues that may contribute to leaks after~     surgery.~   "
67165|NCT02178215|"~     Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are~     many cosmeceutical skin products in which their major action affects skin hydration and skin~     barrier function. In addition, there are some herbal medication remedies used for the~     treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients~     with pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine,~     Siriraj Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up~     appointment showed significant improvement. Nevertheless, the knowledge of using this herbal~     medication for treating pruritic skin rash so far has been categorized as folk wisdom and~     not been confirmed by any clinical-trial study on its efficacy and mechanism of action.~      Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act~     as adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy~     of Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin~     barrier function in atopic dermatitis.~   "
67166|NCT02178202|"~     The purpose of this study was to investigate the effects of HT compared with McK exercise on~     pain and disability in patients with LBP.~   "
67167|NCT02178189|"~     Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early~     caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy~     to implement and could improve early outcomes for these high-risk infants. We will conduct a~     preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for~     methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and~     estimates of whether high-calorie formula results in more normal patterns of weight loss and~     gain, less severe NAS symptoms and shorter hospital stays.~   "
67168|NCT02178176|"~     The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is~     controlled is decreasing over time. This project can have a significant public health impact~     because we are refining and pilot testing a primary-care based intervention aimed at~     improving patient engagement and function which are critical components of diabetes care and~     are associated with improved glycemic control, lower disease-related health-care~     expenditures, and reduced mortality.~   "
67169|NCT02178163|"~     This research trial studies comprehensive genomic analysis in tissue samples from patients~     with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic~     analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and~     help doctors to tailor treatment to target the specific mutations.~   "
67170|NCT02178150|"~     This is a double-blind randomized clinical trial which will start at June 2014 and end on~     June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the~     sample size calculated 70 persons (35 persons for control group and 35 persons for patient~     group). Patient group will receive magnesium supplement (250 milligram) and the other group~     will receive placebo which is similar to the magnesium tablets in color, odor and appearance~     both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records.~     Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will~     be measured at the beginning and end of the study as well as anthropetric measurements.~   "
67171|NCT02178137|"~     There has been intensive search for a substance that can have disease-modifying activity for~     osteoarthritis. A number of medications have been reported to be of benefit on slowing~     progression of knee OA. This trial will be the first head to head comparison of these~     medications.~      Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically~     using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall~     physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence~     grading and will also be measured for joint space narrowing at follow up. The response to~     arthritis medications on slowing down cartilage loss will be measured biochemically with~     COMP levels.~   "
67172|NCT02178124|"~     Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil~     patch in healthy male subjects~   "
67173|NCT02178111|"~     The study hypothesis is that not performing never episiotomies is safe and results are~     equivalent to performing episiotomies ina selective manor.~   "
67174|NCT02178098|"~     This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus~     placebo in patients with hypercholesterolemia and hypertension.~   "
67175|NCT02178085|"~     Background : Glaucoma is a common disease, potentially blinding, characterized by~     progressive damage to the optic nerve. If the intraocular pressure is the most known risk~     factor, however, there are cases of glaucoma scalable despite well-controlled intraocular~     pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension~     (normal tension glaucoma).~      Purpose :Involvement of vascular factors in the development of glaucoma and scalability has~     been proved, associated with a possible loss of vascular autoregulation. The objective of~     this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma~     untreated comparison with control subjects.~   "
67186|NCT02177929|"~     The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy~     activities the groups could show improvement in muscle strength of the arms, decreased~     resistance of the lower limbs (spasticity), improved trunk balance and movements of the~     upper limbs, improves cardiovascular function, bone health, and consequently improve the~     quality of life.~   "
67316|NCT02176200|"~     Study to compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide~     50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same~     dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs~     ) in COPD patients at different inspiratory flow rates.~   "
67176|NCT02178072|"~     The purpose of this study is to assess the activity of 5-azacitidine in patients with Human~     Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma~     (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to~     and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and~     neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment~     with 5-azacitidine increases changes in cancer cells that lead to their death. This study is~     designed to determine if similar changes occur in cancer cells of patients with head and~     neck cancer.~      The study also aims to determine the amount of a specific type of protein, p53 before and~     after treatment. Research has shown that the p53 protein is associated with anti-tumor~     activity.~      Finally, this study is measuring the amount of a specific type of protein called interferon~     in your tumor tissue. Interferons are proteins made and released by the body in response to~     pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons~     allow for communication between cells to trigger the protective defenses of the immune~     system that remove pathogens (disease causing agents) or tumors.~   "
67177|NCT02178059|"~     Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via~     current version of Turbuhaler with inhalation via a new version~   "
67178|NCT02178046|"~     There is a need for toothpastes that more effectively remove oral plaque and prevent~     re-formation. The objective of this study is to map the development and resolution of~     clinical gingivitis using conventional clinical examination and imaging data to determine~     how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth~   "
67179|NCT02178033|"~     An adequate level of bowel preparation is crucial for the efficacy and safety of~     colonoscopy. Strong evidences suggest that bowel-preparation quality shows an inverse~     correlation with length of the interval between the end of cleansing agent intake and the~     start of colonoscopy (shorter intervals are associated with better preparation levels).~     Accordingly, the use of a split-dose administration regimen has been demonstrated to~     significantly improve the quality of preparation, besides patient acceptability, as compared~     with standard administration the day before colonoscopy. All randomized controlled trials~     comparing split versus standard preparations were primarily aimed at assessing the quality~     of colon cleansing, by means of either validated or not-validated colon cleansing scales.~     The impact of a split dose regimen on objective colonoscopy performance measures such as~     adenoma detection rate (ADR) has never been specifically and prospectively evaluated.~      The present study is aimed at evaluating whether the split-dose preparation regimen is~     associated with an increase of adenoma detection.~      For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for~     positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive~     low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a~     full-dose regimen (control arm).~      Treatments are allocated using a computer-generated, randomized code list. The treatment~     allocation is concealed and is accomplished at the screening visit through non-research~     personnel who is not involved in the study. To ensure masking, the endoscopists who perform~     the colonoscopies are not involved in the randomization process and in the pre-procedure~     data collection.~      In this study the the primary outcome measure was the proportion of patients with at least~     one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient~     compliance, tolerability and acceptability were also collected.~      A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a~     relative increase of 25% in the adenoma detection rate in the split dose preparation group,~     assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing~     screening colonoscopy (significance level 0.05, 90% power).~   "
67180|NCT02178020|"~     Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing~     total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced~     to decrease this problem, but there is little data on the results and complications of this~     polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following~     questions: (1) Are there any differences in the clinical and radiographic results when a~     highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency~     of reoperation in these two groups and are there any specific complications related to~     highly cross-linked polyethylene liners.~   "
67181|NCT02177994|"~     A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in~     elective cesarean section 30-60 min before skin incision versus after cord clamping.~   "
67182|NCT02177981|"~     Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe~     CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment~     strategies need to be pursued to respond to the continuous increase in the risk profile of~     contemporary CABG patients. Surgical myocardial revascularization is commonly performed with~     the use of cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on~     the form of a new-onset motor deficit or postoperative cognitive dysfunction. The former is~     rare, but potentially devastating. Conversely, declines in attention, memory and fine motor~     skills can frequently be documented.~      Ischemic preconditioning is a phenomenon of an endogenous protective response to organ~     ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in~     tissues known to be more resistant to ischemic insults. In clinical practice remote ischemic~     preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent~     restitution of flow to the upper extremity. This intervention has been shown to be effective~     in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in~     this research proposal is that RIPC will decrease the extent of postoperative neurological~     injury following CABG.~      In this research project, 70 patients scheduled for an elective CABG will be recruited at a~     single center. They will be randomly allocated to either undergo RIPC (intervention arm) or~     a sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will~     induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a~     5-minute arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be~     induced in this fashion.~      All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the~     brain, as well as neurocognitive testing. The array of MRI tools that will be used for the~     quantification of brain injury will include fluid attenuated inversion recovery, diffusion~     weighted and susceptibility weighted imaging, coupled with resting state functional MRI.~      The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on~     neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.~   "
67183|NCT02177968|"~     The purpose of this study is to identify the prevalence and the characterization of health~     of elderly fallers and non-fallers in the southeastern community of Brazil in the state of~     São Paulo.~   "
67184|NCT02177955|"~     Objective: The aim of the present study was to compare hemodynamic changes using 7.5 mg of~     midazolam and 10.0 mg of diazepam during the surgical removal of symmetrically positioned~     third molars.~      Study design: A prospective, randomized, double-blind, clinical trial was carried out~     involving 120 patients divided in three groups: Group 1 (diazepam and placebo), Group 2~     (midazolam and placebo) and Group 3 (diazepam and midazolam). Each subject underwent two~     surgeries on separate occasions under local anesthesia.~   "
67185|NCT02177942|"~     The effect of supplementation using both protein and multiple micronutrients in preschool~     age children on cognitive performance and growth is unknown. The study will compare the~     effect of combination of protein and multiple micronutrients on indicators of cognitive~     performance and growth in preschool age children. Cognitive performance and anthropometric~     assessments will be measured at baseline and at 6 months.~   "
67317|NCT02176187|"~     Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage~     of the dose received from the Respimat® inhaler and metered dose inhaler~   "
67187|NCT02177916|"~     The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the~     quality and quantity of the education that is provided to patients listed for lung~     transplantation. We propose to change the method and timing of our transplant patient~     education. The objective of this prospective data collection will be to collect and analyze~     pre and post test scores of patients when patient education is provided via compact disc as~     compared to individualized teaching.~   "
67188|NCT02177903|"~     The application of active warming to patients whether awake or under general anesthesia has~     been proven safe in numerous studies and it is common practice to use warmers. The warmers~     are commonly used with both the supplied blankets and also with hospital blankets.~      Subjects receiving standard care will not benefit from this study. Subjects in the~     investigational group may benefit in several ways:~        -  Increased comfort in the pre-operative period by being warmer~        -  Decreased incidence of mild hypothermia~        -  Possible decreased incidence of transfusion with less bleeding~        -  Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)~        -  Possible shorter stay in the PACU and overall Length of Stay (LOS)~        -  Possible decreased risk for surgical site infection~   "
67189|NCT02177890|"~     Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms~     emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as~     on one hand it represents a normal, highly conserved, physiological response to an ingested~     toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of~     pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life,~     adherence to treatment and is a cause for discontinuation of the development of novel~     compounds. Experimentally, nausea can be induced in humans using a visually induced motion~     stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as~     seen from the perspective of a subject standing on Westminster Bridge, London. The tilted~     and rotating view visual display makes the subject perceive that they are spinning round and~     round on a spot tilted away from centre of gravity due to circular vection. This motion~     video induced nausea in approximately 50% of healthy participants and caused a reduction in~     cardiac vagal tone, a validated measure of the parasympathetic nervous system branch on the~     autonomic nervous system. We therefore are evaluating the role of external transcutaneous~     vagal nerve stimulation in visually induced motion sickness.~   "
67190|NCT02177877|"~     This study will assess whether a movement detecting wristwatch can accurately detect~     seizures and seizure characteristics and record them into an online epilepsy diary. The~     patients may manually record a description into the online epilepsy diary of the symptoms~     they experienced before, during or after the seizure.~   "
67191|NCT02177864|"~     The investigators hypothesize that fiber supplementation will provide measurable differences~     in indices of children's health (fewer complaints of abdominal pain and constipation, lower~     body mass index) compared to placebo.~   "
67192|NCT02177851|"~     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem~     worldwide, especially in women of reproductive age and young children. Iron supplementation~     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron~     bioavailability from different supplementation regimens and how to optimize bioavailability~     in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg~     body weight for 3 months is reported to be the most effective method to rapidly increase~     iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often~     prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg~     iron, arguing that the splitting would increase iron bioavailability compared with one~     single high dose. However, there is no scientific evidence for this assumption; to the~     contrary, results from a recent study suggest that iron bioavailability from a second~     supplementation dose of iron after a first supplementation dose of iron is impaired due to~     increased hepcidin levels. To address this bioavailability issue, the present study will~     determine iron absorption from 120 mg iron administered for 3 consecutive days and compare~     it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The~     investigators hypothesize that the iron bioavailability from the single daily dose will be~     lower than that from the 2 doses. By measuring also hepcidin, this study will provide~     important insights on the iron bioavailability from a single dose of iron and on the same~     amount iron split into two doses (b.i.d. administration).~   "
67193|NCT02177838|"~     This pilot clinical trial studies cetuximab and radiation therapy in treating patients with~     stage III-IV head and neck cancer. Monoclonal antibodies, such as cetuximab, may block tumor~     growth in different ways by targeting certain cells. Radiation therapy uses high energy x~     rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving cetuximab or cisplatin together with~     radiation therapy may kill more tumor cells.~   "
67194|NCT02177825|"~     This phase II trial will test the hypothesis that inhibition of c-kit signalling pathways in~     pediatric patients with Neurofibromatosis Type I(NF-1) and progressing plexiform~     neurofibroma will result in objective reduction and/or inhibition of plexiform neurofibromas~     progression.~      This will be a Phase II study of imatinib mesylate given orally. Patients with stable or~     responding disease may receive the drug for a period not exceeding one year.~   "
67195|NCT02177812|"~     This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and~     regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor~     GSK2879552. The recommended dose and regimen will be selected based on the safety,~     pharmacokinetic (PK), and pharmacodynamic (PD) profiles observed after the treatment of~     subjects with relapsed/refractory AML. The study consists of two parts. Part 1 will identify~     the maximum tolerated dose (MTD) and/or RP2D using a dose-escalation procedure. Dose~     escalations will be guided by the Neuenschwander-continual reassessment method (N-CRM).~     PK/PD expansion cohorts will also be included in Part 1 to characterize the range of~     biologically effective doses by assessing PD markers and obtain additional PK data. Part 2~     will explore further the safety, tolerability, and clinical activity of GSK2879552 at the~     RP2D in subjects with AML.~   "
67219|NCT02177500|"~     An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg~     plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic~     blood pressure in patients who fail to respond adequately to telmisartan monotherapy.~   "
67196|NCT02177799|"~     Acute gastroenteritis is a common cause of hospitalization in children with significant~     socioeconomic burden on the health community, we will follow in this observational and~     analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the~     Sheikh Ragheb Harb Hospital over a period of summer time to determine the causes, etiologies~     and epidemiology of Age in a community hospital.~   "
67197|NCT02177786|"~     This study will evaluate the efficacy, safety, and tolerability of selonsertib (formerly~     GS-4997) in participants with diabetic kidney disease (DKD). Participants will be randomized~     with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or~     matching placebo.~   "
67198|NCT02177773|"~     The primary objective of this study is to determine if Gallium-68 labeled DOTA-TOC will~     result in the delineation of more lesions in patients with somatostatin receptor positive~     malignancies than with conventional imaging.~   "
67199|NCT02177760|"~     Study Design: SCID infants receiving an unconditioned haploidentical transplant will be~     started on Sirolimus (0.05 mg/kg/day) day -5 for Acute Graft-Versus-Host Disease (aGVHD)~     prophylaxis. Sirolimus levels will be monitored with goal sirolimus trough level of 5-8~     ng/mL. Patients will be monitored for signs of aGVHD as defined by UCSF SOP CL 221.06~     through day +100. Sirolimus will be tapered once T-regulatory cell to CD4 effector cell~     ratio is > or = 9%.~      Setting: Inpatient BMT Unit Benioff Children's Hospital at UCSF Medical Center~      Study Subjects: 15 infants with diagnosis of maternally engrafted T cells SCID by CA Newborn~     screen receiving unconditioned haploidentical HSCT~      Main Outcome Measures: Incidence of aGVHD (dermatitis, hepatitis, enteritis) as defined by~     SOP CL 221.06 by Day +100.~      Hypothesis 1. Patients placed on sirolimus prophylaxis will have lower incidence of aGVHD~     compared to historical controls.~      Hypothesis 2. Lower doses of sirolimus milligram per kilogram will be required to maintain~     goal troughs of 5-8 ng/mL.~   "
67200|NCT02177747|"~     A subset of 120 diabetic patients underwent dilated examination and smartphone~     ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and~     delivered the smartphone's LED light coaxially to the camera, allowing a clear and~     convenient view of the retina.~   "
67201|NCT02177734|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.~   "
67202|NCT02177721|"~     This field study is designed such that it may be implemented for any individual who has been~     administered raxibacumab for treatment of anthrax or for post exposure prophylaxis including~     sporadic cases, small anthrax incidents and/or a mass event. This study is designed to~     describe the clinical effectiveness (including course of illness and survival), safety~     profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with~     raxibacumab as part of their clinical care following exposure to B. anthracis. Study data~     and samples for PK and other investigational research will be collected prospectively to the~     extent possible at pre-specified time points. However, because of the logistical~     complexities that would likely accompany a mass anthrax event, most data in this study is~     anticipated to be collected retrospectively. During such a mass anthrax event scavenged~     blood samples will be utilized where possible to maximize sample analyses for PK and other~     investigational parameters. Therefore, both retrospective and prospective data collection~     are allowed in this protocol in order to maximize the amount of information obtained in~     subjects who have been administered raxibacumab. This field study will be the first~     opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to~     better understand the clinical benefit and safety of the drug and to further inform patient~     care and treatment choices for management of anthrax~   "
67203|NCT02177708|"~     There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is~     tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to~     osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE~     patients or used indirect methods.~      Methods: The investigators wish to describes quantitative measurement of localized water~     content using MRI water mapping in a cohort of patients with cirrhosis during an episode of~     overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history~     of HE and healthy subjects will be investigated as controls.~   "
67204|NCT02177695|"~     The primary focus of this study is to see if looking at tumor biomarkers using a program~     called coexpression extrapolation or COXEN may predict a patient's response to~     chemotherapy before surgery.~   "
67205|NCT02177682|"~     Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma~     models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple~     myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and~     efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This~     is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the~     subjects meet any study treatment withdrawal criteria including disease progression. A total~     of up to 24 subjects will be enrolled in the study.~   "
67206|NCT02177669|"~     The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial~     vision and predicts functional vision better than visual acuity, but long testing times~     prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al.~     (2010) developed the qCSF method to obtain precise CSF measurements in only 30-50 trials~     using a computerized software program that presents letters on a large monitor that are~     identified by a patient similar to typical visual acuity testing with an eye chart. The~     quick CSF method is a Bayesian adaptive method that estimates the full shape of the CSF, and~     the test duration is only about 3-6 minutes. Some preliminary testing has been performed at~     other sites with this test in patients with vision loss due to amblyopia and glaucoma, but~     data from individuals without eye disease who have normal visual acuity has not been~     systematically collected with the latest version of this test procedure across a wide range~     of ages. In addition, we aim to gain a better understanding of the typical test-retest~     variability that is obtained between-sessions that are about a week apart from individuals~     with good ocular health and visual acuity.~   "
67220|NCT02177487|"~     Study to assess the safety of six month of open-label, treatment with the fixed dose~     combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients~     with mild-to-moderate hypertension who completed the eight week randomized, double blind~     502.261 study.~   "
67207|NCT02177656|"~     This study will test the effectiveness of motivational interviewing and skill building~     compared to usual care to improve self-care in heart failure (HF) patients. The target~     population is HF patients recruited from the Hospital of the University of Pennsylvania~     after an in-patient admission. Patients in the intervention arms will receive one home-visit~     from a nurse who does a self-care intervention followed up by 3 follow-up phone calls.~   "
67208|NCT02177643|"~     Considering that, Diacerein is on the market for almost 20 years, being used continuously in~     elderly patients with osteoarthritis without present significant side effects, and~     considering the anti-hyperglycemic effect and the improvement in the insulin resistance~     observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim~     of our study is to investigate the effect of Diacerein, a medication with~     anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and~     antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory~     cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the~     glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to~     metformin treatment.~   "
67209|NCT02177630|"~     The purpose of this study is the assess the diagnostic performance of magnetic resonance~     imaging in patients with suspected myocarditis by applying different imaging sequences at~     different MR scanners~   "
67210|NCT02177617|"~     This study aims to compare Botox injections without Physical Therapy sessions to Botox~     injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is~     expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms~     and quality of life more than Botox alone. It is also expected that Botox combined with~     Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new~     connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after~     Botox injection.~   "
67211|NCT02177604|"~     Previous research has shown that indulging in 50% more calories than required for as little~     as 3 days can significantly impact markers of metabolic health in lean and overweight~     individuals. Here, the investigators will determine if 3 brief sessions of high-intensity~     interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in~     sedentary, overweight males.~   "
67212|NCT02177591|"~     The prevalence of cardiovascular disease is rising; new methods must be created to assess~     the cardiovascular status of patients. If cardiovascular disease can be predicted, it may~     facilitate prevention. An association between periodontal disease and cardiovascular has~     been established, but a definitive mechanism is not understood. A good first step in finding~     that mechanism is to look at the correlation between periodontal disease and cardiovascular~     disease, both of which have an inflammatory component. This study observes the level of~     cardiovascular disease in patients and correlates it with the presence and degree of~     periodontal pathogens.~   "
67213|NCT02177578|"~     In this study patients will be treated with 6 weeks of radiation therapy plus temozolomide~     chemotherapy according to the standard of care. However, the radiation treatment plan will~     be modified to deliver an higher than routine radiation dose to the subventricular zone~     which is an area of the brain that contains stem cells that some scientists believe may~     contribute to glioblastoma recurrence. The purpose of the study is to see if the tumor is~     controlled for a longer period of time in patients treated with this modified radiation~     technique than it is in patients treated with standard radiation therapy plus temozolomide~     chemotherapy.~   "
67214|NCT02177565|"~     Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.~   "
67215|NCT02177552|"~     The main purpose of this study is to determine the effects of treatment with carboplatin,~     docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.~   "
67216|NCT02177539|"~     The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate~     + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply~     cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)~   "
67217|NCT02177526|"~     Management of prostatic carcinoma varies according to stage of disease. Trans-rectal~     ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling~     and random non-targeted technique. Methods to improve pre-operative tumor localization and~     grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area~     of research but requires further validation.~      High grade tumors can undergo comedo-type necrosis with malignant calcifications which only~     occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using~     computed tomography (CT) and/or MRI.~      Detection of malignant calcification within tumor foci will improve the accuracy of~     localization and grading in prostatic carcinoma.~   "
67218|NCT02177513|"~     Background:~      - Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions,~     attention, and behavior after they take marijuana in different ways. They want to learn~     better ways to detect drugs in a person s body They also want to know how long marijuana can~     be found in blood, urine, saliva, and breath.~      Objectives:~      - To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component)~     and how their bodies handle it after it is given in different ways.~      Eligibility:~      - Adults age 18 50 who use marijuana.~      Design:~        -  Participants are screened under another NIDA protocol.~        -  This study involves up to 6 visits to NIDA.~        -  At the first visit, participants will practice the tasks and tests they will do at~          their dosing sessions. They will learn how to give breath and saliva samples.~        -  Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a~          research clinic the night before these sessions. Some participants can stay at the~          clinic and some must go home between sessions.~        -  At each session, participants will eat a brownie with placebo or marijuana. Then they~          will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana~          after it is vaporized.~        -  Throughout the sessions:~        -  Participants will give urine, saliva, and breath samples. Their blood will be taken~          with a tube in a vein and finger pricks. Their vital signs will be checked.~        -  Participants will answer questionnaires and take thinking tests. They will also take~          tests that assess eye movement, balance, and time estimation.~        -  Participants may have a 5th dosing session. They will eat a marijuana brownie and have~          the above tests and samples.~   "
67221|NCT02177474|"~     In a randomized controlled trial the investigators intended to evaluate the effect of a~     telephone based peer support intervention on depressed or anxious women with coronary heart~     disease (CHD). The investigators intended to include 198 depressed or anxious women aged~     over 18 years with CHD. Participants were randomized to intervention (IG) or waiting list~     (WL). IG was offered immediate telephone-based contact to peer counselors while WL received~     the offer with a 6-month delay. All participants got at least one telephone call by a~     clinical psychologist (study information, feedback about the individual level of distress,~     proposal to get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived~     social support (F-SozU K-14). In an additional quasi-experimental trial, the investigators~     included 11 peer counselors and 11 matched controls not taking part in the intervention.~     Main outcome variables were mood states (POMS) and perceived social support (F-SozU K-14).~   "
67222|NCT02177461|"~     Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared~     with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.~   "
67223|NCT02177448|"~     The efficacy and safety of Telmisartan capsule in patients with essential hypertension were~     evaluated in comparison with Enalapril Maleate in the double blind trial.~   "
67224|NCT02177435|"~     Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus~     hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80)~     alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated~     trough diastolic blood pressure (DBP) after eight weeks of treatment.~   "
67225|NCT02177422|"~     The primary objective of this trial was to assess the efficacy and safety of telmisartan 80~     mg during open-label, long-term treatment. An additional objective was to assess the~     efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ~     (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of~     hypertension.~   "
67226|NCT02177409|"~     The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering~     ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing~     interval in patients with mild-to-moderate hypertension as measured by ambulatory blood~     pressure monitoring (ABPM)~   "
67227|NCT02177396|"~     The primary aim of the trial was to compare the effect of telmisartan and valsartan in~     lowering ambulatory diastolic and/or systolic blood pressure in the last six hours of the~     dosing interval. Secondary variables included changes from baseline in diastolic and~     systolic blood pressures during other times during the 24-hour ABPM profile, changes from~     baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff,~     and responder rates. Assessment of safety was also considered. Adverse events and use of~     concomitant therapies were monitored at each study visit. Blood pressure and heart rate were~     collected at each visit. Physical examination, electrocardiograms (ECG) and laboratory tests~     were completed during the trial as well.~   "
67228|NCT02177383|"~     There are conflicting evidences of the effects of dietary supplementation with~     polyunsaturated fatty acids (PUFAs) on athletic performance. The investigators working~     hypothesis is based on the polyunsaturated fatty acids, given its pro-oxidative character~     and also by its action on transcription factors can modulate the antioxidant response and~     oxidative damage induced by physical activity.The overall objective of the study is to~     establish situations improving athletic performance and study the oxidative balance by~     manipulation of feeding patterns and consumption of nutritional supplements and investigate~     the involved mechanisms.~   "
67229|NCT02177370|"~     The aim of the study was to compare the effect of fenoterol metered dose inhaler with~     disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population~     as well as on the clinical findings in patients with bronchial asthma over a two-week period~     of treatment.~   "
67230|NCT02177357|"~     The objectives of this study were to evaluate the efficacy, safety, and tolerability of~     pramipexole, as single-agent therapy or in combination with levodopa, in patients with~     Parkinson disease living in Hong Kong and Taiwan.~   "
67231|NCT02177344|"~     The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of~     ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical~     comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol~     (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary~     disease (COPD). The efficacy and safety profiles of the two doses administered via the~     RESPIMAT device will also be compared to their respective placebo groups~   "
67232|NCT02177331|"~     In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to~     provide long-term data on its impact on liver function, glucose homoeostasis and lipid~     metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be~     studied.~   "
67233|NCT02177318|"~     To collect post-marketing safety and effectiveness information on the use of Tiotropium~     Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily~     clinical settings~   "
67234|NCT02177305|"~     Safety and tolerability after ocular administration~   "
67235|NCT02177292|"~     The purpose of this study is to find out the effects (good and bad) of using newer~     technologies that allow very precise delivery of radiation. These newer technologies are~     Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).~   "
67236|NCT02177279|"~     There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran~     are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It~     is still not clear exactly why this happens, but it is likely that the compounds which enter~     our bodies when we eat such products are responsible. In this study we plan to find out what~     these compounds are and where they are found. The investigators will do this by asking~     volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood,~     urine and stool samples over the next twenty-four hours. Once the investigators know how~     much and which compounds are present, we can then find out possible reasons why they are~     protective, for example by looking to see whether they are anti-inflammatory. We also plan~     to look at whether if having a diet which contains either a lot of wheat-bran products or~     very low amounts of these foods effects how they are absorbed by the body.~      HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are~     metabolized to compounds responsible for high cellular bioactivity imparting important~     health benefits.~   "
67237|NCT02177266|"~     The study will determine the benefit of Colchicine versus placebo for cardiac surgery~     patients on the post-operative development of atrial fibrillation and post-pericardiotomy~     syndrome.~      Primary Objective. Colchicine will reduce the composite endpoint of incidence of~     post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following~     cardiac surgery.~      Secondary Objectives.~        1. Colchicine will reduce the incidence of constrictive physiology on echocardiography at~          3 months following cardiac surgery.~        2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3~          months following cardiac surgery with the use of colchicine.~   "
67238|NCT02177253|"~     The primary objective of this study was to compare the long-term (12-week) bronchodilator~     efficacy and safety of ipratropium bromide / salbutamol combination administered by the~     Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two~     inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo~     formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An~     additional objective was to show the superiority of Combivent Respimat as compared to~     ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing~     interval following four weeks of therapy were also characterized.~   "
67239|NCT02177240|"~     The purpose of this study is to determine if the Flex-it® Articulating Stylet or the~     GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult~     GlideScope® intubations.~   "
67240|NCT02177227|"~     The purpose of our study is to determine, using a prospective, randomized-controlled trial,~     the economic viability and clinical outcomes associated with patient-specific~     instrumentation (PSI) for total knee arthroplasty in an obese patient population.~   "
67241|NCT02177214|"~     Purpose of the study is the visualization of the mesh and the determination of the mesh~     surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh~     visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to~     visualize the mesh position in vivo in a safe manner. This provides long-term benefit to~     early recognize possible recurrence caused by shifting or shrinking of the mesh and to~     provide early treatment.~   "
67242|NCT02177201|"~     Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or~     adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of~     super-hydration with 0.9% saline in children undergoing specifically elective~     otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended~     period of fasting that interrupts the perfusion in gut. Based on this knowledge, we~     hypothesized that administration of supplemental fluid would reduce the incidence of~     postoperative vomiting.~   "
67243|NCT02177188|"~     In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life~     Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR),~     arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and~     temperature. However, some of these signs, such as hypotension and tachycardia, lack~     specificity and sensitivity and do not occur early enough. Even with an early preload~     reduction, blood pressure can remain constant due to compensatory mechanisms, such as~     vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor~     specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that~     among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90~     bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting~     from other stimuli influencing heart rate, such as pain, fear, circulating hormones and~     endogenous enkephalins. Therefore, it could be very useful to have an index that identifies~     initial volume variation, when physiological regulatory mechanisms are still effectively~     maintaining normal BP.~      Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between~     the onset of ventricular depolarization and ventricular ejection) and vascular transit time~     (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral~     arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP,~     showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the~     head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt~     angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early~     sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening~     the PTT increase, since PTT is influenced by both continuous PEP increase and progressive~     VTT decrease occurring during hypovolaemia.~      Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT~     is the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular~     depolarization (the 'R' wave of the ECG trace) to the systolic peak of the~     photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG~     to counteract sympathetic activation that would dampen PEP increase and enhance VTT~     reduction, by means of positive inotropism and peripheral vasoconstriction, respectively.~     iHAT therefore increases during haemorrhage because of preload reduction and the consequent~     PEP increase and RR interval decrease. iHAT is expressed as the time percentage of the~     interbeat interval (RR) it takes to the PPG waveform to travel to peripheral arteries. In~     this study iHAT has been calculated as the average of beat-to-beat mPTT/RR ratios over 30~     heart beats (corresponding to at least 2 breathing cycles) in order to minimize the effect~     of spontaneous breathing on preload, and thus on PEP and PTT.~      In the present study, the investigators aimed to evaluate iHAT in a simulating model of~     hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates~     haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model~     of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in~     2001 Convertino suggested it is a useful device to test severe haemorrhage-related~     hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique~     to study physiological behaviours in humans.~      The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The~     secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared~     to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess~     feasibility of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a~     haemorrhagic model and to evaluate CO changes with respect to measured hemodynamic~     variables.~      TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use~     in an emergency setting.~   "
67244|NCT02177175|"~     The purpose of this study is to find out the effects, good and/or bad, of a beta blocker~     (carvedilol) on heart function during treatment with anti-HER2 medication(s) including~     trastuzumab (Herceptin).~   "
67245|NCT02177162|"~     Physiotherapists' knee OA care is suboptimal. Exercise therapy including a combination of~     aerobic, muscle strengthening and functional exercises is not always performed and a lot of~     treatments are used for which there is no evidence. By a continuing education session and a~     pop-up in the electronic patient file, this study wants to improve knee OA care by focusing~     on combined exercise therapy.~      The study will be performed in collaboration with Pro-Q-Kine, an independent organization~     implementing quality improvement in Belgian physiotherapists' care. Besides Pro-Q-Kine the~     study will be performed in collaboration with two or three software producers of~     physiotherapists' electronic patient files that reached a national homologation for their~     respective software packages and covering a large part of the Flemish physiotherapists.~      Pro-Q-Kine will organize sessions of continuing education with a focus on optimal knee OA~     care. These sessions will be performed in LOK-groups (local peer-groups of physiotherapists~     who meet each other for continuing education). At these sessions the physiotherapists will~     be asked to take part to the study. A pop-up will be installed in the electronic patient~     file of the participating physiotherapists, lightening up when physiotherapists register a~     patient with knee OA. The pop-up includes a short message about optimal knee OA care. The~     physiotherapists will also receive a script for a query in their electronic patient files in~     order to extract those patients that initiated a treatment for knee OA between 1 year and 3~     months before the therapists received education. These patients will receive a letter of~     their respective physiotherapists in which they are addressed to take part to the study. An~     informed consent, patient questionnaire and retour-envelope will be included. There will~     also be the opportunity to complete the questionnaire electronically with an electronic~     informed consent. The patient questionnaire will include some background details (such as~     age and gender) and details about the physiotherapeutic treatments they received for knee~     OA. The patient questionnaire will be coded with a number, referring to the physiotherapist~     and to the individual patient (the first patient of the first physiotherapist will be coded~     as 1.01, the 10th patient of the 14th physiotherapist will be coded as 14.10). Patients'~     names will not be revealed to the investigators and physiotherapists will not have any~     access to the completed patients' questionnaires. The general practitioners in the~     environment of the physiotherapist will (probably) receive a letter from the researchers.~     This letter will contain information about the importance of referral to a physiotherapist~     in knee OA care and about knee OA care in general. This letter will also refer to the study~     that is going on in physiotherapists' care, without details.~      Six months after the installation of the pop-up, the physiotherapists will be asked again to~     perform the query to extract patients out of the electronic patient file that have been~     treated for knee OA and whose treatment sessions had been started in the period of three~     months from the installation of the pop-up.~   "
67246|NCT02177149|"~     The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision~     support system for individual patient management will enable considerable time savings~     compared to standard care. This hypothesis was formulated from pilot studies that showed~     dramatic decreases in DBS programming time compared to standard care for clinicians who used~     an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes.~     Study group Parkinson's patients with DBS Systems~   "
67247|NCT02177136|"~     This is a phase 2, double-blind, placebo controlled trial in patients with primary~     sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in~     particular, serum alkaline phosphatase; and, safety.~   "
67248|NCT02177123|"~     The purpose of this study is to collect additional safety and effectiveness data on the~     InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who~     are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥~     18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.~   "
67249|NCT02177110|"~     This is an exploratory prospective translational multicentre study. Melanoma is the 5th most~     common cancer diagnosed in Ireland and its incidence among women and men is above the~     European average.~      Following treatment the elimination of cancer cells ultimately occurs by the activation of~     apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical~     systems of modelling, quantitative biochemistry and cell biology, and specifically predicts~     the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.~      The investigators propose to validate the SYS-ACT approach and application in a~     translational systems medicine study.~   "
67267|NCT02176876|"~     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple~     infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be~     randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every~     2 weeks, for a total of 3 IV infusions.~   "
67250|NCT02177097|"~     Revision surgery after total hip or knee arthroplasty is an ongoing issue due to an~     increasing number of primary surgeries. Patients seek physicians due to pain. The cause is~     divided between loosening, infection or chronic pain. Some are operated on the suspicion of~     a chronic infection. However, postoperative microbiological testing does not always~     correlate with the suspicion and the operation may have been superfluous.~      The objective is to employ a highly advanced diagnostic algorithm based on state of the art~     diagnostic techniques in order to improve the basis of preoperative diagnosis. Through this~     approach treatment can be given according to the causal problem.~   "
67251|NCT02177084|"~     The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS)~     associated with conservative therapy (arm A) for the treatment of low anterior resection~     syndrome (LARS) compared with only conservative therapy (arm B).~      The secondary aims are the evaluation of the following parameters:~        -  Effect of PTNS on manometric parameters~        -  Effect of PTNS on quality of life~        -  Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation~        -  Safety of PTNS~   "
67252|NCT02177071|"~     Phase IV~      Design : Prospective, open-label, randomized three-arms study~      Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at~     least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1~     year~      Primary objective To demonstrate that Infliximab scheduled maintenance with or without~     antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free~     remission over 2 years, while the latter is non inferior with regards to the mean time spent~     in remission over the same duration~      Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2~     years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.~      Number of subjects 300 randomized patients (100 per arm)~      Study duration: 2 + 2 years Enrollment: 2 years Follow-up: 2 years~   "
67253|NCT02177058|"~     This project directly addresses the national imperative for innovative strategies to improve~     care for Medicare beneficiaries and reduce health care costs. The overall objective of the~     proposed project is to improve the care of older individuals who reside in nursing homes~     (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be~     accomplished by testing a quality improvement program designed to reduce the number of~     avoidable hospitalizations of NH residents in a randomized controlled trial.~      The primary hypotheses to be tested are:~      Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will~     have a greater reduction in hospitalization rate than the control and monitoring only NHs~     during the 12-month implementation compared to a 12-month baseline period.~      Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT~     implementation NHs will be greater than the estimated costs of implementing the~     intervention.~      Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among~     patients on the Medicare skilled benefit for post-acute care, than for long-stay patients.~      Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those~     NHs with higher vs. lower intensity (fidelity) of implementing the program.~      Hypothesis 5: There will be a greater reduction in measures of hospitalizations for~     conditions defined as potentially preventable than for other transfers and~     hospitalizations.~      Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant~     quality measures in the participating NHs.~   "
67254|NCT02177045|"~     Breast lesions are a common condition, diagnosed by imaging and palpation. In order to~     reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an~     imaging method with a high degree of accuracy is needed. Ultrasound imaging with~     microbubbles contrast media allows the diagnosis of vascularization of the lesion, according~     to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early~     timing is most likely to represent a malignant lesion and thus, deserves biopsy for a~     definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be~     suitable to perform this examination.~   "
67255|NCT02177032|"~     Demonstrate non-inferiority of the immune response between new versus the currently~     recommended intradermal regimens of rabies vaccine when administered with or without rabies~     immunoglobulins in healthy subjects ≥ 1 years of age.~   "
67256|NCT02177019|"~     The research project is a component of a mentored research career enhancement award. The~     purpose of the award is to help the PI and his collaborators prepare for future research~     grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The~     research project is a feasibility study with the following specific aims; 1) to assess~     outcomes associated with a personalized health plan for frequent headaches; 2) to identify~     measurable outcomes that are meaningful to patients with frequent headaches; and 3) to~     create a patient stakeholder group to inform patient-centered outcomes research for frequent~     headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established~     patients at the Duke Family Medicine Center who have frequent headaches. The intervention~     consists of 3 study visits with the PI, 2 clinical consultations with subjects' established~     primary care provider at the Duke Pickens Family Medicine Center, and participation in 2~     focus groups. Personalized health plans might consist of a combination of medical~     management, lifestyle changes, nutrition counseling, or other therapeutic modalities as~     appropriate. Data analysis will be descriptive; no formal hypotheses will be tested.~   "
67268|NCT02176863|"~     This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel~     group clinical trial with adaptive dose selection in subjects with post polio syndrome~     (PPS).~      The main purpose of this study is to select a dose of Flebogamma 5% DIF and confirm the~     efficacy of the selected Flebogamma 5% DIF dose by assessing physical performance, as~     measured by 2 Minutes Walk Distance (2MWD) test.~   "
67269|NCT02176850|"~     This post-marketing surveillance study was designed to supplement under conditions of normal~     clinical practice the data on the safety, tolerability and efficacy of Micardis® collected~     during the clinical studies.~   "
67270|NCT02176837|"~     The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the~     reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral~     aneurysm.~   "
67714|NCT02171013|"~     To establish the bioequivalence of two drug product batches of dabigatran etexilate, one~     batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate~     polymorph II in addition to polymorph I~   "
67257|NCT02177006|"~     Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk.~     Pediatric clinicians can provide important sun protection counseling. In 2003, the United~     States Preventive Services Task Force determined that clinician counseling has an effect on~     use of sunscreen for children but not for other sun protection measures such as protective~     clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in~     adults as well as nevi in children, but reliance on sunscreen as the only form of sun~     protection is problematic.~      This novel research seeks to develop a sun protection program that is feasible for pediatric~     clinicians to deliver with patient-centered messages and systems to support program~     implementation in the clinical offices. The sun protection messages will enable behavioral~     change by the stakeholders (caregivers and children) that will reduce painful sunburns in~     the children and eventually reduce the incidence of melanoma. Testing the feasibility of~     delivering the intervention in a pediatric practice will enhance the sustainability of the~     intervention, and lead the way to dissemination of good practice.~      This proposal seeks to develop and test an intervention that seeks to improve sun protection~     of young children. The intervention includes two phases:~      Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection~     provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory~     guidance sheet provided by the practice to caregivers of children 2-6 years of age.~      Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported~     surveys~      We hypothesize that redemption of the vouchers will be associated with the perception of the~     child having sun sensitive skin.~   "
67258|NCT02176993|"~     The investigators goal is to improve the outcome of patients with acute stroke by inducing~     mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using~     EMCOOLS Brain.Pads®.~      For this project, the investigators can build further on their research group's experience~     with hypothermia in animal models and invasive cooling in stroke patients.~      The COOL program will prospectively evaluate safety, feasibility, patient acceptance and~     efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of~     patients presenting with acute stroke at the Emergency Department of the Universitair~     Ziekenhuis Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine~     clinical practice in a randomized controlled trial. If proven to be safe, feasible,~     well-tolerated and efficacious in the inhospital setting, future use in prehospital acute~     stroke care will be incorporated with telemedicine support, as part of the Prehospital~     Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB).~   "
67259|NCT02176980|"~     Subjects are being asked to take part in a research study to test two levels of alcohol~     services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ~     in intensity of alcohol services and in whether or not they include a focus on liver health.~     The study will look at which level of alcohol services best decreases alcohol use among~     patients with HCV.~   "
67260|NCT02176967|"~     This phase III trial studies how well response and biology-based risk factor-guided therapy~     works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may~     not need treatment until it progresses. In this case, observation may be sufficient.~     Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and~     what the best treatment is. Response and biology-based risk factor-guided therapy may be~     effective in treating patients with non-high risk neuroblastoma and may help to avoid some~     of the risks and side effects related to standard treatment.~   "
67261|NCT02176954|"~     The aim of this study is to investigate the influence of the adhesive wafer design on the~     products ability to fit to the body..~   "
67262|NCT02176941|"~     The prevailing view in telomere epidemiology is that leukocyte telomere length (LTL) is~     associated with atherosclerosis and accelerated aging since it serves as a biomarker of the~     cumulative burden of inflammation and oxidative stress during adult life. Our recent results~     however, indicate that telomere length (TL) is mainly determined at birth and childhood.~     Since short telomeres ante cede atherosclerosis, the investigators hypothesize that TL is~     not just a simple marker, but a real determinant of arterial aging. That is because TL~     reflects cellular repair capacity and a short LTL denotes diminished repair reserves. This~     hypothesis cannot be tested by measurements of LTL alone, since this parameter reflects TL~     at birth and its age-dependent attrition thereafter. The investigators propose, therefore, a~     model that makes it possible to examine different elements of TL dynamics in different~     tissues: leukocytes, skeletal muscle, endothelial progenitor cells (EPCs), skin or~     subcutaneous fat in patients with or without atherosclerosis.~      Our model is based on the following premises, which are derived from observations that TL is~     synchronized (equivalent) across somatic tissues/cells of the newborn:~        -  TL in skeletal muscle mainly reflects TL at birth~        -  The difference in TL between muscle and leukocytes in adults (approximately 1.5 Kbp)~          mainly reflects LTL attrition during the growth period, i.e., childhood/adolescence~        -  TL in EPCs determines the cell proliferative ability and therefore capacity for vessels~          repair during aging.~      The general aim of the present project is to examine the links of arterial aging with TL, as~     expressed in different tissues, and LTL dynamics, as expressed in the difference between TLs~     of muscle and leukocytes.~   "
67263|NCT02176928|"~     The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment~     in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the~     treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality,~     health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate~     measures in persons with chronic SCI.~   "
67264|NCT02176915|"~     The Fresh Start postpartum weight loss program will test the effectiveness of a group-based~     weight loss intervention that includes videos featuring peers who have successfully achieved~     postpartum weight loss. The group-based condition will be compared to a control condition~     involving print materials related to weight loss.~   "
67265|NCT02176902|"~     This randomized phase II trial will evaluate if a low-fat diet with fish oil has the~     potential to delay disease progression in patients with prostate cancer undergoing active~     surveillance.~   "
67266|NCT02176889|"~     The purpose of this study is to determine whether Lactospore is safe in healthy adults.~   "
67291|NCT02176551|"~     The purpose of this study is to evaluate the safety and efficacy of product 0405 in~     pediatric subjects with Mild to Moderate Atopic Dermatitis.~   "
67271|NCT02176824|"~     Chronotherapy is a term that describes therapeutic alterations of sleep wake cycles.~     Different variations of sleep deprivation, set sleep wake schedules, and types of light~     therapy have demonstrated efficacy in rapidly treating depression, and suicidal thinking.~     This study seeks to explore the effect of two different chronotherapuetic protocols on~     acutely depressed and suicidal inpatients admitted to the Medical University of South~     Carolina~   "
67272|NCT02176811|"~     The study searched for answers to two questions:~      1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease~     and healthy controls.~      2. Is there any relationship between plasma betatropin levels and different stage of~     non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin~     levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.~   "
67273|NCT02176785|"~     Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation~     technology that has demonstrated the ability to temporarily increase or decrease activity in~     specific regions of the brain. The researchers are investigating the effect of this~     technology on sleep propensity by applying two different types of stimulation as well as~     sham (Placebo) stimulation during three different afternoon naps. The researchers are~     subsequently hoping to recruit healthy volunteers without medical, or sleep problems who~     have a regular sleep schedule to participate in the study~   "
67274|NCT02176772|"~     Background: The disease burden of tuberculosis (TB), second only to HIV/AIDS among~     infectious diseases, is a major public health problem in developing countries. Accumulating~     evidence suggests that iron status is a primary determinant of TB progression. Anaemia is~     prevalent in patients with TB, particularly in sub-Saharan Africa, and associated with~     increased mortality. Anaemia in TB may be due to inflammation, dietary iron deficiency, or~     both, and distinguishing among these aetiologies is difficult. Iron supplementation is~     commonly used to treat anaemia in TB patients, but may be unnecessary if inflammation is the~     cause. Body iron sequestered by TB inflammation can be mobilized during treatment and used~     to correct the anaemia. Moreover, supplemental iron may be retained within macrophages,~     potentially increasing susceptibility to TB and leading to a poorer clinical outcome. Thus,~     better understanding of iron metabolism during TB and the aetiology of TB-related anaemia~     would clarify the potential role of iron in pathogenesis and optimal management of the~     disease.~      The investigators hypothesize that: a) TB will increase circulating hepcidin and thereby~     impair dietary iron absorption and systemic utilization of iron, resulting in iron~     sequestration and anaemia; b) TB treatment and resolution of inflammation over 6 months will~     decrease circulating hepcidin, correcting these impairments and improving iron status and~     hemoglobin; c) the majority of iron utilized to replenish hemoglobin during recovery from TB~     will come from mobilization of sequestered iron stores rather than from iron absorption.~      Objectives: Use iron stable isotopes to characterize iron balance over six months of TB~     treatment, and specifically to: a) quantify oral and intravenous iron incorporation (oral~     absorption and systemic iron utilization) at three time points during TB treatment (acute~     disease, after the intensive treatment phase and at completion of the continuation treatment~     phase); and b) determine the effect of treatment on iron mobilization from stores to~     replenish hemoglobin.~      Methods/Subjects: Using a triple stable-isotope technique, iron absorption from labelled~     test meals (57Fe) and systemic iron utilization after labelled intravenous doses (54Fe,~     58Fe) will be determined in 18 Tanzanian subjects with newly diagnosed pulmonary TB. The~     subjects will be studied at three time points (i) the day after TB diagnosis while infected,~     (ii) after 8 weeks of intensive phase treatment, and (iii) after another 16 weeks of~     continuation phase treatment. Iron status, hemoglobin, hepcidin and inflammation indexes~     will be measured at each time point. Isotope enrichment during the two treatment phases will~     be measured to estimate the relative rates of iron absorption and mobilization from stores~     during the intensive and continuation phases to determine the relative contributions of iron~     absorption and iron mobilization from stores during TB treatment and recovery.~      Outcome: These studies will provide important new insights into the aetiology of anaemia and~     iron metabolism in TB patients. The results will provide essential data for evidence-based~     recommendations on the timing, administration route and efficacy of iron therapy in patients~     with TB, making possible, a safer and more effective treatment of anaemia in TB while~     decreasing morbidity and mortality from the disease.~   "
67275|NCT02176759|"~     Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify~     rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the~     food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance~     the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP~     need to be investigated. The primary objectives of the present study are: 1) to test whether~     the presence of citrate in iron fortified rice with FePP results in higher iron~     bioavailability, and 2) to test whether the presence of citrate in the rice grain during the~     extrusion and cooking process results in higher iron bioavailability compared with~     iron-fortified rice where citrate has been added shortly before consumption. As a secondary~     objective the investigators will compare the absorption from different FePP combinations~     with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the~     addition of citrate enhances iron absorption and that the positive effect is greater when~     the citrate is added during the extrusion.~      The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to~     evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2)~     regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate~     added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at~     the time of consumption. Iron absorption will be measured as erythrocyte incorporation of~     stable iron isotopes at least 14 days after the administration of the isotopically labelled~     test meals. The iron absorption from the different meals within the same participant will be~     compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.~      The present study will provide important data where iron bioavailability from rice is~     accurately and directly measured using stable isotopic labels as absorption tracers. This~     direct data can be used to base decisions on the level of fortification, can potentially~     reduce costs and optimize iron delivery to the targeted population in iron fortification~     programs.~   "
67276|NCT02176746|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor~     immunity.~   "
67277|NCT02176733|"~     The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission~     of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive~     blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral~     bilateralisation taking place in the vast majority of cases in weeks or months. The~     neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting~     the anti-apoptotic mechanisms) are particularly promising.~      The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase~     of the disease process and would limit the loss of visual acuity and improve the visual~     prognosis of these patients.~   "
67278|NCT02176720|"~     It was previously shown that [18F]Fluorodopa (FDOPA) PET imaging results in intended~     management changes in 41% of brain tumor patients. However, its impact on patient outcome~     defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory~     agencies require randomized trials to determine the impact of PET on patient management and~     outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient~     outcome by more accurately identifying presence or absence of tumor recurrence than~     conventional imaging.~   "
67279|NCT02176707|"~     As there are no validated tools for assessing patient reported outcomes or health related~     quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised~     different methods. This means that comparison of the outcomes of studies is difficult or~     inaccurate. By collecting different quality of life tools and patient reported outcome at~     the same time, it will be possible to map or model the results of one tool or groups of~     tools onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings~     Brief Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC~     dyspnoea scale, University of California, San Diego shortness of breath questionnaire and~     the Hospital Anxiety and Depression Scale, along with spirometry every 3 months, and undergo~     a 6 minute walk test every 6 months, over a 12 month period. Prognostic models will be~     constructed from all the clinical (questionnaire and function) measures a linear regression~     model.~   "
67280|NCT02176694|"~     A randomized controlled trial of a texting intervention to increase adherence to~     preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary~     care clinics.~   "
67292|NCT02176538|"~     The purpose of this study is to evaluate the safety and efficacy of product 0405 in~     pediatric subjects with Mild to Moderate Atopic Dermatitis.~   "
67293|NCT02176525|"~     The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics~     of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both~     treatment-naïve patients and patients previously treated with peginterferon and ribavirin~     were included. In addition, the effect of study medication was examined in a group of~     patients with liver cirrhosis.~   "
67281|NCT02176681|"~     Diabetes is a major concern for dialysis units, as it is now the most common cause of~     end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than~     one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type~     2 diabetes) and especially in East part of France.~      Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly~     from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients~     has an important impact in reducing risk of progression nephropathy. Data are scarce on how~     diabetes should best be treated in dialysis patients. The evidence for improving glycaemic~     control in patients on dialysis having an impact on mortality or morbidity is sparse.~     Indeed, many factors make improving glycaemic control in patients on dialysis very~     challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring~     difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.~      Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are~     contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment.~     Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues~     have become available, but until recently, renal failure has precluded their use. Newer~     gliptins, however, are now licensed for use in 'severe renal failure', although they have~     yet to be trialed in dialysis patients.~      The investigators study, using continuous glucose monitoring as a new tool for monitoring of~     therapy should provide information on vildagliptin in add on therapy to insulin in this~     population.~   "
67282|NCT02176668|"~     The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of~     YH4808 New Formulation in healthy volunteers.~   "
67283|NCT02176655|"~     This study proposes to compare the efficacy of sumatriptan and aspirin to placebo as an~     acute abortive treatment for delayed alcohol induced headache in adult subjects.~   "
67284|NCT02176642|"~     This is a randomized double-blind placebo-controlled clinical trial of posterior tibial~     nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills)~     in women undergoing treatment of urgency urinary incontinence (UUI).~      The investigators hypothesize that combination therapy with PTNS and anticholinergic~     medication will result in a significant incremental improvement in UUI symptoms over that~     achieved with PTNS alone. In addition, the investigators hypothesize that the addition of~     anticholinergics to PTNS will result in a greater improvement in patients' perception of~     treatment response, symptom distress, and quality of life than PTNS alone.~      Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day~     using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus~     placebo in women undergoing treatment for UUI.~      Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus~     anticholinergic medication versus PTNS plus placebo.~      Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of~     life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the~     Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire~     Short Form (OABq-SF).~      An interim analysis will be conducted by an independent entity after 50 participants have~     completed the study protocol. A Data Safety Monitoring Board is not utilized because the~     study utilizes FDA approved treatments for urgency urinary incontinence.~   "
67285|NCT02176629|"~     Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these~     disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) ,~     as well as pathophysiological processes are frequently found and involved significantly in~     maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation~     is the most common disorder behavior and early stages of cognitive impairment. Apathy is~     particularly associated with cognitive difficulties such as attention deficit disorder -~     concentration.~      In terms of prevention as term care , there is now a broad consensus that interventions on~     cognition and behavior must not be limited to pharmacological treatment but should also~     promote non-drug approaches.~      Interest in video games (serious games and serious games) as intervention support~     rehabilitation is growing. Similarly, the virtual reality (VR) and the new information~     technologies and communications offer significant opportunities in terms of rehabilitation~     and therapeutic assistance.~      This protocol is part of a European project to propose techniques for improving the~     treatment of people at risk of social exclusion ( VERVE project ) aims .~      A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in~     healthy elderly subjects. In a second step , it is important to validate the feasibility of~     using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in~     mild to moderate in a clinical environment.~      This is a biomedical , randomized given to a group of patients with mild cognitive~     impairment or Alzheimer's disease & diseases associated with mild to moderate.~   "
67286|NCT02176616|"~     1. Purpose of the study~      1) To compare clinical outcome, procedure time, complication rate of patients who were~     changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between~     ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary~     vein isolation with conventional linear ablation.~      2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. However, there are no consensus for proper ablation strategy in patients who were~          changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .~        5. additional ablation make extent of myocardial injury and paradoxically increase~          recurrence rate, thus still controversial.~        6. Therefore, we will compare conventional pulmonary vein isolation with additional~          conventional linear ablation.~      3. Methods~        1. Treatment of All patients with atrial fibrillation is performed according to the~          standard treatment guideline of atrial fibrillation.~        2. there is no additional blood sampling, imaging study, or any other invasive procedure~          according to the inclusion of the study.~      4. study contents~      1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial~     fibrillation from persistent atrial fibrillation~        -  compare conventional pulmonary vein isolation with additional liner ablation, both~          strategies are conventional ablation strategies being performed world-wide.~   "
67287|NCT02176603|"~     The purpose of this study is to determine whether adolescent and adult patients with~     phenylketonuria who are on long-term phenylalanine-restricted diet suffer from endothelial~     dysfunction.~   "
67288|NCT02176590|"~     This project will test the proximal and distal effects of an integrated dual-generation~     intervention, Power PATH, in Head Start preschoolers and their parents in Alabama.~   "
67289|NCT02176577|"~     The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the~     Treatment of Atopic Dermatitis in Adolescent Subjects.~   "
67290|NCT02176564|"~     A pharmaco-epidemiological, observational study that aimed at assessing in a prospective~     manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease~     (COPD) patients treated with inhaled bronchodilators~   "
67295|NCT02176499|"~     Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate~     hypertensive patients on a controlled sodium diet as well as to explore the effects of~     telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine~     potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was~     assessed whether the natriuretic effect disappears after treatment when telmisartan is~     stopped. The effects of telmisartan on seated clinic blood pressure and the relationship~     between urine sodium loss and decrease in ambulatory blood pressure after the first dose~     were assessed descriptively. Assessment of safety was also considered.~   "
67296|NCT02176486|"~     The purpose of this study is to characterize the safety and tolerability of ixazomib when~     administered as multiple oral doses at escalating dose levels in participants with lupus~     nephritis.~   "
67297|NCT02176473|"~     In an open-label feasibility study, fifteen will be recruited to participate in the study~     from among those who have already chosen of their own accord to undergo ECT (standard of~     care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients~     will receive computer-assisted cognitive behavior therapy (CCBT).~   "
67298|NCT02176460|"~     Uric acid may be involved in the activation of the innate immune response in osteoarthritis~     (OA) pathology and progression. This suggests that traditional gout therapy may be~     beneficial for OA. Our goal therefore is to assess colchicine, an existing commercially~     available agent for gout, for a new therapeutic indication-knee OA. The investigators~     propose a randomized clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral~     colchicine or placebo for knee OA. The investigators hypothesize that colchicine will block~     inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce~     synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers.~     This trial will potentially provide data to support a new treatment option for knee OA.~   "
67299|NCT02176434|"~     This pilot study of combined kidney and hematopoietic stem cell transplantation attempts to~     establish a protocol to induce immunological tolerance as a new strategy to prevent renal~     graft rejection. If successful, this strategy would restore renal function, while avoiding~     the risks associated with long-term standard anti-rejection therapy, and would represent the~     first option to cure end-stage renal disease.~   "
67300|NCT02176421|"~     A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for~     the correction of skin depressions in the infra-orbital area (under the eyes)~   "
67301|NCT02176408|"~     Major depressive disorder (MDD) is the leading cause of disability in the developed world~     and is associated with lost productivity, increased health care utilization, and mortality.~     Several empirically supported treatments, such as antidepressant medication and cognitive~     behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many~     as 34% of individuals do not respond to these treatments. Exercise and stretching~     interventions represent alternative strategies associated with strong effect sizes in past~     studies. Additionally, exercise has been shown to enhance cognitive functioning, especially~     attention and memory. This study aims to investigate the effect of a combined aerobic~     exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment~     involves completing both pleasant and mastery-based activities with the goal of enhancing~     mood. The current study will recruit 32 MDD patients for an active treatment phase of nine~     60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise~     (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding~     aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an~     active control condition.~   "
67302|NCT02176395|"~     The purpose of this study is to explore the pharmacological mechanism of Danhong injection~     in the treatment of acute ischemic stroke.~   "
67303|NCT02176382|"~     The aim of the study is to assess the effect of an antiresorptive medication in combination~     with standard dose or alternate dose teriparatide.~   "
67304|NCT02176369|"~     Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death~     worldwide with 1.4 millions of deaths every years. Current standard therapies include~     platinum-containing drugs but at one year from diagnosis the survival rate is still low~     (30-40%) .~      The purpose of this study is to evaluate the role of a platinum-free drug, named~     Vinorelbine, administered by the so called metronomic schedule in order to prolong the~     progression free survival of patients.~   "
67305|NCT02176356|"~     A study to evaluate patient satisfaction, aesthetic and psychological impact of combined~     treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA~     PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).~   "
67306|NCT02176330|"~     The purpose of this study is to assess the impact of using a virtual clinic which combines a~     web-based interactive questionnaire (ePAQ-PF) used in advance of clinic appointments in~     combination with a telephone consultation has on patient experience and cost compared to~     standard care.~   "
67307|NCT02176317|"~     This study is a prospective phase 1 single-center trial designed to determine the safety of~     a single intravenous infusion of autologous umbilical cord blood in children with Autism~     Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine~     which measure(s) can be used as primary and secondary endpoints for a future randomized~     phase 2 clinical trial. All subjects will receive infusion of cord blood cells at baseline~     with follow up assessments at 6 and 12 months.~   "
67318|NCT02176174|"~     Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary~     by ethnic group. However, less is known about differences between ethnic groups and a wider~     range of cardiovascular diseases. This study will examine differences between ethnic groups~     (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve~     different cardiovascular diseases. This information may help to predict the onset of~     cardiovascular diseases and inform disease prevention strategies.~      The hypothesis is that different ethnic groups have differing associations with the range of~     cardiovascular diseases studied.~   "
67319|NCT02176161|"~     This is a Phase II clinical study to determine if Metformin can increase Prostate Specific~     Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary~     treatment with radiation, or surgical patients that are at high risk for recurrence based on~     surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will~     receive Metformin and will be monitored for PSA response and disease progression.~   "
67308|NCT02176304|"~     Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the~     aging population, a 40% patient increase is expected to present at clinics with complaints~     of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical~     criteria for knee arthritis and usage of resources to avoid major surgery. It has long been~     accepted as a treatment option for patients who have failed to respond to NSAIDs and other~     non-surgical therapies to receive intra-articular injections of steroid and anesthesia~     mixtures to hold off disease progression.~      Various studies have compared different sites of injection and the accuracy rate of the~     injection being within the joint. Recent studies report a 66% accuracy on palpation-guided~     injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the~     superolateral portal of the knee, and new studies show an improvement of up to 98% with use~     of ultrasound guiding software. However, in a health care system with limited resources,~     providing patients with US-guided injections represented an increased cost of $178.35 per~     patient as per 2010 Medicare reports.~      Therefore, assuming these accuracy rates, we will compare the anterolateral and~     superolateral portals for knee injection and their clinical effect to monitor if in fact~     there is a difference in patient reported outcomes. As a secondary analysis, if no~     difference is found, a strong case for palpation-guided injections versus ultrasound-guided~     injections can be made.~      In this study we will prospectively enroll 60 patients to be divided into two 30 patient~     groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated~     with an intraarticular knee injection through an anterolateral portal or a suprapatellar~     portal as per group in which they are placed. Scores will be given for pain of the injection~     and of the baseline illness and compared on a subsequent visit to assess self-reported~     functional outcomes.~   "
67309|NCT02176291|"~     The purposes of this project are to examine the feasibility, safety, tolerability and~     clinical effect of low-dose buprenorphine as a novel treatment for late-life~     treatment-resistant depression and to develop preliminary data about mechanism of action.~   "
67310|NCT02176278|"~     In this quality improvement program (DKD-TMT), patients will be recruited from multiple~     sites across Asia, with each site recruiting at least 300 type 2 diabetic patients with~     Diabetic Kidney Disease (DKD). After explanation by trained doctors and nurses, and with~     written informed consent, patients will be randomized to the UC (n=100, usual care) group,~     the EC (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group.~     Patients in all 3 groups will undergo a comprehensive assessment (CA) guided by the~     templates in the Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12.~     They will also self-administer a set of questionnaires for assessing quality of life and~     psychological distress during the CA at both time points.~      During the 12 months between the 2 CAs:~        -  Patients in the UC group will receive UC in accordance to the practice of the health~          institution.~        -  Patients in the EC group will receive a JADE summary report with personalized risk~          prediction, treatment targets and decision support with explanation from the doctor and~          nurse. In addition to receiving UC in accordance to the practice of the health~          institution, the nurse will telephone the patient 3-monthly to remind them to adhere to~          treatment, provide support and empower them to discuss with their doctors about their~          treatment needs and any concerns.~        -  Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to~          achieve multiple targets, but tailored to patients' risk profile. The patients will~          receive telephone reminders and also be given a JADE follow up report 3-monthly.~      The primary composite endpoint is attainment of treatment goals and/or control of risk~     factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The~     tertiary changes are behavioral changes, psychological well-being and quality of life.~   "
67311|NCT02176265|"~     Objective of this First in Man study is to assess feasibility and safety of Qvanteq's~     bioactive coronary stent for treatment of stable coronary artery disease patients with de~     novo coronary artery stenosis in native vessels.~      The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth~     behavior of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth~     (similar to BMS), which however is not resulting in excessive tissue overgrowth as observed~     in BMS but rather has an efficacy profile similar to drug-eluting stent (DES), meaning~     suppression of tissue overgrowth. This should reduce the risk of restenosis and thrombus~     formation despite the presence of a short term dual anti platelet therapy (DAPT).~     Furthermore, prolonged DAPT time as applied with current DES increases the bleeding risk of~     patients.~      The study is a prospective, multicenter, open-label, single arm study; conducted in up to 6~     cardiology centers in CH and NL. In total, approx. 35 patients will be enrolled. All~     patients will be treated with the Qvanteq's bioactive coronary stent. Clinical follow-up~     will occur at 1, 6 & 12 months post-stent implantation. All patients will undergo~     angiography assessment (QCA) and Optical Coherence Tomography investigation (OCT) at~     baseline and at 6 months follow-up. Baseline OCT should be performed after the successfully~     completed angiographic procedure (documentary OCT). 1 and 12 months clinical follow-ups are~     conducted via telephone.~      Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by off-line~     QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by off-line OCT~     analysis.~   "
67312|NCT02176252|"~     The study is designed to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7~     days in order to allow for including Japanese subjects in future global studies. A cohort of~     Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by~     digital ECGs (dECG) recordings, also in Caucasian subjects.~   "
67313|NCT02176239|"~     The purpose of this study is to demonstrate the utility of measuring outcomes in 5%~     treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD)~     patients using infusion nurse and patient measured physical, quality of life (QOL),~     respiratory, and disability assessments using CareExchange in the home setting.~   "
67314|NCT02176226|"~     This study will evaluate a Smartphone intervention for depression and anxiety that uses~     machine learning to tailor treatment for patients. The intervention, referred to as~     IntelliCare, delivers patient-specific treatment material and motivational messaging via a~     mobile phone, to help individuals with depression and/or anxiety. Information and data~     received from the patient will inform the tailored treatment approach through machine~     learning. The purpose of this study is to obtain preliminary information on the feasibility~     and effectiveness of IntelliCare in improving symptoms of depression and anxiety.~   "
67315|NCT02176213|"~     This study is being done to learn more about the drug, pomalidomide and to gather data on~     its safety and side effects when used in combination with commercially available~     cyclophosphamide and dexamethasone. This combination is considered experimental and has not~     been approved by the FDA.~      Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent~     version of thalidomide and lenalidomide drugs that have been approved by the United States~     Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide~     was also approved by the FDA for patients with MM who have had more than 2 types of therapy.~      Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also~     taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially~     available and are often used in combination with other drugs to treat Multiple Myeloma.~     Preliminary data from both the laboratory and patient studies suggest that this combination~     of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen~     being used in this study, which consists of daily cyclophosphamide, also permits support of~     low blood counts with either injections or transfusions as needed.~   "
67320|NCT02176148|"~     Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many~     presentations. Its effect on physical appearance greatly affects patients' quality of life.~     In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical~     therapies are the mainstay of cutaneous lupus treatment; however patients often find these~     treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease~     patients are often placed on concurrent systemic therapies. The primary hypothesis of our~     study is that poor adherence contributes to poor treatment outcomes in patients with~     cutaneous lupus.~   "
67321|NCT02176135|"~     The main purpose of the study is to evaluate the safety of oral auranofin, a gold compound,~     in patients with HIV infection whose viral load has been suppressed by antiretroviral~     therapy for no less than 3 years and have a CD4+ cell count over 500 cells/uL~   "
67322|NCT02176122|"~     No randomized controlled trials (RCTs) have yet been performed comparing different treatment~     options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen~     an exponentially increasing rate of carbapenem resistance worldwide, including Australia and~     New Zealand. The investigators urgently need data from well-designed RCTs to guide~     clinicians in the treatment of antibiotic resistant Gram-negative infections. The~     investigators face a situation where a commonly used antibiotic for these infections~     (meropenem) may be driving carbapenem resistance. For this reason, the investigators are~     seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these~     infections. Formal evaluation of safety and efficacy of generic antibiotics in the treatment~     of infection is of immense clinical and public health importance, and no formal trial has~     yet been conducted to address these issues. The international collaboration between teams of~     clinician researchers, some of whom are leaders in their field, makes it highly likely that~     the outcomes of this trial will have a significant impact on clinical practice.~      The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen)~     is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of~     bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or~     Klebsiella species.~   "
67323|NCT02176109|"~     In this study, the investigators study the prognostic role of oxidative stress metabolism~     and iron in Acute myeloid leukemia.~   "
67324|NCT02176096|"~     The objective of this demonstration project is to compare a novel long-acting starch,~     Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy~     tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I.~     Glycosade has been reported to increase the duration of euglycaemia. Its slow release and~     longer periods of normal blood sugar achieved would preclude the need for the overnight~     dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube~     for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus~     potentially improving compliance to therapy. The investigators intend to evaluate Glycosade~     in our patients and determine its efficacy on glucose control, on the length of~     normoglycemia achieved and to determine if there are reduced side effects in our patients~     with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients~     who consent to the protocol.~   "
67325|NCT02176083|"~     Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments~     that impair ovarian function and result in significant reproductive health late effects.~     These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal~     dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this~     pilot study is to test the feasibility of a 4-week text message based intervention on hot~     flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the~     intervention (text messages on hot flash and vaginal dryness management) and control arms.~     All participants will be prompted to provide daily hot flash frequency and severity via text~     messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting~     via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash~     severity and vagina dryness between the intervention and control arms.~   "
67326|NCT02176070|"~     The purpose of this study is to learn about reproductive health, including fertility and~     pregnancies, in people with vasculitis.~   "
67327|NCT02176057|"~     The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can~     be eliminated in communities in Nepal following mass antibiotic distributions with~     azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis~     infection. The overall objective is to determine if the current World Health Organization~     (WHO) treatment strategy results in elimination of trachoma and infection.~        1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham~          districts of Nepal which receive mass antibiotic treatments will achieve elimination of~          trachoma as a public health problem (clinical disease <5% in children 1-9 years old)~          more frequently than communities which have not received antibiotic treatments.~        2. The investigators hypothesize that infection with C. trachomatis will be undetectable~          in all members within a community following mass treatment as determined by the most~          highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur,~          Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will~          achieve elimination of trachoma as a public health problem (clinical disease <5% in~          children 1-9 years old) more frequently than communities which have not received~          antibiotic treatments.~      2. The investigators hypothesize that infection with C. trachomatis will be undetectable in~     all members within a community following mass treatment as determined by the most highly~     sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based~     AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and~     DNA-based AMPLICOR PCR).~   "
67343|NCT02175849|"~     Tuberculosis burden in Vietnam increasing with contribution from low detection rates and~     increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant~     Tuberculosis) among both notified TB cases and their contacts in the community. Traditional~     contact tracing often focuses on household contacts while strains of TB circulate in homes,~     schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach~     which includes a set of persons and the connections among them used for analysis of~     structure of disease transmission.~      In this study, SNA will be used to collect network data from 60 newly detected Rifampicin~     resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to~     identify and test potential MDR-TB cases.~   "
67328|NCT02176044|"~     Spatial working memory (ability to remember where objects are in space) is impaired in~     patients with schizophrenia. It is thought that this impairment occurs due to problems with~     the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA)~     glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation~     leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA~     receptor function would therefore be predicted to lead to reductions in Nitric Oxide~     production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric~     oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative~     symptoms). In this study, the investigators will test the hypothesis that sodium~     nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients~     will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their~     performance on a spatial working memory task will be tested before and after administration~     of sodium nitroprusside or placebo.~   "
67329|NCT02176031|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug Natalizumab in treating Acute Graft versus Host Disease in the~     Gastrointestinal Tract.~   "
67330|NCT02176018|"~     The purpose of this study is to evaluate the efficacy and effectiveness of daily~     dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic~     migraine.~   "
67331|NCT02176005|"~     The purpose of this study is to determine whether DAV132 is safe and effective for capturing~     fecal residues of moxifloxacin in healthy volunteers.~   "
67332|NCT02175992|"~     Pancreatic cancer has a high mortality rate. Patients with an intended curative resection~     show a median survival of 17-23 months. Therefore, quality of life is very important in this~     patient group. In this study, the effect of pancreatic surgery on quality of life is~     measured.~   "
67333|NCT02175979|"~     The main objective is to investigate the effects of perioperative nutrition on postoperative~     ileus and anastomotic leakage in patients undergoing colorectal surgery.~      Perioperative enteral nutrition is compared to the standard of care (fasting~     perioperatively).~   "
67334|NCT02175966|"~     The purpose of the study is to determine whether the combination of Daclatasvir (DCV),~     Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C~     virus.~   "
67335|NCT02175953|"~     This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a~     specifically on the needs of caregivers of people with dementia composed new short-term~     psychotherapeutical intervention.~   "
67336|NCT02175940|"~     This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in~     eyes with mCNV treated with IVB.~   "
67337|NCT02175927|"~     No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as~     second-line treatment for Helicobacter pylori infection. The study aims to compare the~     effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with~     classical quadruple regiment for rescue eradication of Helicobacter pylori.~   "
67338|NCT02175914|"~     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world~     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly~     affects the risk. Around one third of all genetic disorders as well as most cases of~     Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur~     as a result of premature nonsense mutations (creating a stop codon) in an individual's~     adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in~     the DNA that prematurely halt the protein translation process, producing a shortened,~     nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the~     premature stop codon signal, the resulting protein may be able to ameliorate or stop the~     disease.~      Recently, members of the aminoglycoside family of antibiotics have been found to induce~     ribosomal read-through of nonsense mutations, leading to expression of a full length,~     functional protein. Investigators have recently shown that members of the aminoglycoside and~     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC~     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.~      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin~     to induce read-through of the nonsense mutations in the APC gene and to induce expression of~     a full length, functional APC protein in patients suffering from FAP and to tests its effect~     on adenoma number and size and on desmoid tumors in these patients. The future goal is to~     maximize the effect of stop-codon suppressors on APC while minimizing side effects.~      In this study investigators will select FAP patients which carry APC nonsense mutations,~     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as~     well as abdominal desmoid tumors, that will be documented before during and after treatment.~     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as~     blood samples from these patients for changes in expression levels of the APC protein and~     related oncogenic markers.~      Suppression of nonsense mutations within the APC gene should be of benefit for patients~     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or~     diffuse CRC. Furthermore, given the rapid progress being made in the identification of~     different nonsense mutations in human genes that lead to mostly un-curable disease, the~     identification of clinically approved compounds that suppress nonsense mutations and that~     can be administered long-term without significant side effects would open new venues in the~     treatment of genetic human diseases that arise from pre-mature stop codons in important~     coding sequences.~      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation~     in FAP patients. The read-through effect of erythromycin will be clinically tested by~     counting and measuring the number and size of both colonic and duodenal adenomas before and~     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas~     and desmoid tumors will be tested by western blot, immunofluorescence and~     immunohistochemistry for restoration of APC expression and changes in oncogenic markers.~     These experiments should be conducted within 6 month.~      Long term objective:~        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia~          and CRC in patients expressing a truncated APC protein due to nonsense mutations.~        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC~          nonsense mutation suppression using in-vitro methods. Investigators will focus on~          macrolide antibiotics that are currently in clinical use and are administrated for long~          terms. These objectives should take around 6 month and will be conducted in parallel.~   "
67339|NCT02175901|"~     No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple~     therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and~     safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple~     regiment for Helicobacter pylori eradication.~   "
67340|NCT02175888|"~     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem~     worldwide, especially in women of reproductive age and young children. Iron supplementation~     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron~     bioavailability from different supplementation regimens and how to optimize bioavailability~     in a cost-effective and patient-friendly way. The present study will test whether the~     fractional and total iron absorption from iron supplements (60 mg) administered daily for 14~     days differs from that of iron supplements (60 mg) administered every second day for 28~     days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron~     absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole~     supplementation period. We hypothesize that the fractional and total iron absorption from~     the daily administration of 60 mg is lower than that from the administration on every second~     day due to increased SHep levels when supplements are administered daily.~      The study will provide important insights about the optimization of iron bioavailability~     from different supplementation regimens including the performance of SHep, a key regulator~     of human iron metabolism.~   "
67341|NCT02175875|"~     The study will investigate the effect of the oral antiplatelet agent ticagrelor (Brilique)~     when it is administrated through a nasogastric tube in comatose patients. The platelet~     function can be determined by various platelet function tests (PFT), Multiplate and~     VerifyNow . As control, the reference intervals from the literature are used. Futhermore,~     plasma concentrations of the active metabolite will be determined at aeveral timepoints~     after first intake of a bolus dose.~   "
67342|NCT02175862|"~     In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service~     (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of~     Denmark.~      In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus~     Hesselfeldt, conducted an observational study to investigate the possible effects on time to~     definitive care, secondary transfers and 30-day mortality in a before and after design.~      Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min~     to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day~     mortality significantly reduced from 29 % to 14 % in the year after implementation.~      The present study is an observational cohort study with long-term follow-up of the same~     trauma population as mentioned above. Patients were followed until may 1st, 2014.~      Primary outcome is early retirement and secondary outcomes are quality of life and~     mortality.~      The investigators hypothesize that a greater proportion of trauma patients in the after~     period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients~     treated in the before period.~   "
67344|NCT02175836|"~     Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic~     Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern~     Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden~     Cardiac Death Prediction.~   "
67345|NCT02175823|"~     To improve quality of life of elderly cancer survivors~        1. Using physical activity and environmental sensing technology~        2. Monitoring physiological indicators of cancer recurrence~             -  Analyzing the patient's circadian rhythm, frailty and his/her vital sign.~             -  Vital sign includes blood pressure, weight and hrv.~        3. Collecting the patient information in real time~             -  Giving alarm information to the patient, if any special cases our system found.~             -  Giving circadian rhythm report to the patient.~             -  Giving healthy report to the patient, collected from his/her vital sign.~   "
67346|NCT02175810|"~     Obesity is a growing problem worldwide and its prevention has become one of the leading~     priorities for the World Health Organisation. Obesity results from chronic imbalance between~     energy intake and energy expenditure. Although early prevention of obesity is preferable,~     surgical treatment is often required for severely obese people.~      Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight~     loss following bariatric surgery results in significant improvements in coexisting~     comorbidities, such as diabetes and hypertension but there is controversy whether bariatric~     surgery also improves aerobic capacity.~      The purpose of this study is to investigate the effects of bariatric surgery on~     cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric~     surgery will improve aerobic capacity and result in beneficial lifestyle changes from~     sedentary to more active.~   "
67347|NCT02175797|"~     The purpose of this study is to report the stability of atrial and ventricular leads by~     absence of effect of the MRI exam on the pacing and sensing threshold and to report the~     safety based on the serious adverse events.~   "
67348|NCT02175784|"~     The purpose of this study is to assess the efficacy (superiority to placebo) of~     ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2~     diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The~     long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.~   "
67349|NCT02175771|"~     The primary objective of the study is to evaluate the long-term safety of fluticasone~     propionate inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation~     powder in 2 strengths when administered with the Teva MDPI device over 26 weeks in patients~     with persistent asthma~   "
67350|NCT02175758|"~     This study will have two parts as follows:~      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and~     confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric~     participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days~     of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.~      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate~     SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the~     Treatment Phase with no interruption of study drug administration. The Treatment Phase will~     evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in~     pediatric participants with genotype 2 or 3 HCV infection, respectively.~   "
67351|NCT02175745|"~     This clinical trial compares fluorine F 18 fluorodopa (18F FDOPA) positron emission~     tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in~     patients with glioma that is newly diagnosed or recurrent (has returned). 18F FDOPA is a~     radioactive drug that binds to tumor cells and is captured in images by PET. Computed~     tomography (CT) and MRI are used with PET to describe information regarding the function,~     location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in~     helping doctors find and measure brain tumors.~   "
67352|NCT02175732|"~     Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that~     arise through living with and managing diabetes. High DD is characterized by feeling~     frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a~     negative impact on disease management and glycemic control; poor glycemic control can also~     have a negative effect on DD.~      Few interventions have been assessed that directly target DD or mood in adults with Type 1~     diabetes. In this study the investigators will compare two active, evidence-based behavioral~     interventions to reduce high DD and improve glycemic control and disease management:~        1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in~          diabetes education and behavioral management.~        2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal~          stresses and strains of having diabetes.~      Participants in both arms will attend a single, day-long workshop, four hour-long web group~     meetings and four personal phone calls with the group facilitator during the intervention~     period. Assessments will be carried out at baseline and at three and nine months.~      Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at~     follow-up.~      Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the~     difference between the two study arms and primary outcome.~      Hypothesis 3: The differences between the two study arms and changes in the primary outcomes~     will be qualified by patient characteristics such as age, length of diagnosis, higher~     baseline distress or HbA1c.~   "
67353|NCT02175719|"~     Investigation of the clinical condition in patients with cervical dystonia by Toronto~     Western Spasmodic Torticollis Scale (TWSTRS)~   "
67365|NCT02175563|"~     According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of~     approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary~     resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR~     performers should compress the sternum of a compression in an oblique direction, such as in~     elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that~     the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to~     support the pelvis and thorax because the pregnant uterus can compress the inferior vena~     cava. We hypothesized Smartphone based chest compression feedback app would improves quality~     of CPR in an angulated surface.~   "
67374|NCT02175446|"~     In the second-line treatment setting for MBC, many agents, including antitubulin drugs~     (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated~     activity, but no agent is clearly superior. Although some combinations of cytotoxic agents~     provide a small progression-free survival advantage, none has demonstrated an OS advantage,~     and toxicity is generally greater than for single agents. At present, there is no standard~     for this treatment setting. New treatments that could delay disease progression without~     systemic toxicity would represent a significant advancement.~   "
67354|NCT02175706|"~     Rationale:~      The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease~     has led to a significant reduction in morbidity but there are further demands on DES~     performance. Such demands are an optimized performance in very challenging coronary lesions;~     third generation DES were developed in an effort to further improve DES performance in such~     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus~     Element stents) are currently available; there are no data that indicate an advantage of one~     of these DES over the other.~      Objective:~      To investigate whether the clinical outcome is similar after implantation of the Promus~     Element versus the Resolute Integrity stent (non-inferiority hypothesis).~      Study design:~      Multicenter, prospective, randomized single-blinded study.~      Study population:~      Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary~     stenoses with an indication for DES use, according to current guidelines and/or the~     operators clinical judgement. All clinical syndromes will be included.~      Intervention:~      In patients who are eligible for DES implantation, the type of DES implanted will be~     randomized (Resolute Integrity stent versus Promus Element stent). At the start of the~     study, both DES will also be used in routine clinical practice.~      Main study endpoints:~      The primary endpoint is the incidence of target vessel failure at one year follow-up. Target~     vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI,~     or clinically driven target vessel revascularization. Further secondary clinical and~     angiographic endpoints will be investigated, defined in accordance with suggestions of the~     Academic Research Consortium (ARC). Of note, the angiographic assessment is based on~     clinically indicated projections only and results in no additional x-ray exposure. There is~     no routine angiographic follow-up. If angiographic data are available in patients who~     undergo symptom-driven re-catheterization, we will analyze these data to get insight into~     the mechanisms of potential DES restenosis.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients will receive the routine clinical treatment. As a consequence, the~     risks of this trial do not exceed the risks of any routine PCI procedure.~   "
67355|NCT02175693|"~     Investigation of the clinical condition and safety in patients with cervical dystonia~   "
67356|NCT02175680|"~     This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability~     of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable~     on combination antiretroviral therapy.~      Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140~     monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the~     one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study~     treatment, and one week overlap at the end of the treatment in subjects who do not~     experience virologic failure.~   "
67357|NCT02175667|"~     Determine the influence of a treatment with Global Postural Reeducation techniques and the~     personality traits in the stabilometric parameters~   "
67358|NCT02175654|"~     The purpose of this study is to assess the efficacy of single-agent regorafenib in the~     second-line treatment in metastatic colorectal cancer with any RAS or BRAF mutation~     previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at~     6 months.~   "
67359|NCT02175641|"~     This goal of this randomized controlled effectiveness trial is to compare the effectiveness~     of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in~     supportive housing agencies in New York City and Philadelphia serving diverse clients with~     serious mental illness who are overweight or obese. The intervention follows the Group~     Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been~     shown to help people achieve clinically significant weight loss (equal to or greater than 5%~     weight loss of initial weight). The intervention will be delivered by trained~     peer-specialists employed at the supportive housing agencies and supervised by the study~     team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by~     improving people's diet and increasing their physical activity and consists of weekly core~     group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance~     monthly sessions (6 mo.).~      We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI~     equal to or greater than 25) from our two supportive housing agencies. Clients will be~     randomized to either the Peer-led healthy lifestyle intervention or usual care conditions.~     The primary outcome for this study is achieving clinically significant weight loss (equal to~     or greater than 5% weight loss from baseline weight) at 12 and 18 months post randomization.~     The secondary outcomes for this study include overall reductions in weight, waist~     circumference, blood pressure, and improvements in physical activity, self-efficacy,~     recovery and health-related quality of life. Repeated assessments will be at baseline, 6, 12~     and 18 month post randomization.~      Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving~     clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18~     months than UC participants.~      Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant~     reductions in average weight, waist circumference, blood pressure, and significant~     improvements in physical activity, self-efficacy, recovery, and health-related quality of~     life in Peer GLB compared to UC.~   "
67360|NCT02175628|"~     Purpose: This study will evaluate a new ultrasound imaging technology called acoustic~     angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved~     for use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses~     ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike~     traditional angiography and mammography. Specific goals will be to evaluate the quality of~     the images provided by acoustic angiography in the human breast, and furthermore to evaluate~     whether or not acoustic angiography provides additional diagnostic information over~     traditional ultrasound which could provide an improvement in assessing breast lesions.~     Specifically, this additional diagnostic information will hopefully enable us to reduce~     false positive tests and discriminate lethal cancers from non-lethal disease.~      Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who~     are undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions).~      Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with~     standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be~     conducted to compare these modalities. Finally, the images will be analyzed with image~     processing techniques to determine quantitative metrics exhibited by the blood vessel~     morphology in the images. These metrics will be utilized to develop a malignancy score~     equation to predict malignancy of a lesion.~   "
67361|NCT02175615|"~     The specific objectives of this study are:~      Primary:~      1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and~     severe aGVHD (grade III and IV)~      Secondary:~        1. To determine the relationship between individual concentration-time points achieved~          prior to engraftment and severe aGVHD (grade III and IV)~        2. To validate the previously developed LSS to determine cyclosporine AUC after IV~          administration at steady state and~        3. To describe the relationship between cyclosporine AUC and individual concentration-time~          points achieved prior to engraftment and other HSCT outcomes (clinically significant~          aGVHD (grade II to IV), hypertension, engraftment failure, relapse~   "
67362|NCT02175602|"~     The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and~     BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.~   "
67363|NCT02175589|"~     The purpose of this study is to evaluate the effect of discontinuation of colchicine~     treatment in a specific group of asymptomatic FMF patients with a single mutation in MEFV~     gene, both from a clinical and laboratory aspects.~   "
67364|NCT02175576|"~     Randomized Controlled Study to determine if preservation of ligaments provides increased~     functional ability post-operatively in comparison to traditional TKA which sacrifices soft~     tissue.~   "
67715|NCT02171000|"~     To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral~     administration of multiple doses (150 mg b.i.d., 7 days)~   "
67366|NCT02175550|"~     A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The~     implant is a two piece design to allow both one- and two- stage surgical procedures. The~     entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to~     promote and maintain primary stability, which later on leads to secondary stability.~      NR CC implants are used as the foundation for anchoring tooth replacements in either jaw.~     Restorations range from replacing one single tooth to an entire arch of bridgework. The~     implants are also intended as retentive elements for overdenture applications.~      The present study is designed to evaluate, after the insertion of the NR CC, the marginal~     bone levels and bone remodelling at the implant sites over various time points up to 5~     years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing~     (BoP) are as well evaluated together with implant success and survival rate.~      Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this~     clinical investigation will demonstrate clinical safety and reliability of the NR CC using~     different treatment options.~   "
67367|NCT02175537|"~     The purpose of the study is to pilot-phase test the effectiveness of the microclinic social~     induction model and its effects on behavioral and metabolic outcomes in different levels of~     social and familial relationships in Qatar. The investigators novel microclinic model is~     based on the principle that both healthy and unhealthy behaviors spread through preexisting~     social networks. A microclinic is a small group of approximately 2-8 friends or family~     members who are taught to modify their own behaviors as well as the behaviors of those~     around them, with a particular focus on the four M's: Meals, Movement, Monitoring, and~     Medication. More than social support groups or peer-to-peer interventions, the microclinic~     model is unique in its focus on the long-term propagation of healthy behaviors throughout a~     participant's entire social network. Qatar is uniquely positioned (with its central~     geographic location in the Gulf region and its leadership in science and education) to~     spearhead a regional intervention focused on managing and preventing diabetes in the Gulf~     region.~   "
67368|NCT02175524|"~     The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS),~     the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal~     patients. The current study was designed as a case-control study. Patients proved to be oral~     and esophageal cancer and had the habit of areca nut chewing are defined as case group.~     Patients proved to be oral and esophageal cancer and did not have the habit of areca nut~     chewing are defined as control group. The participants' age, blood pressures, and smoking~     habits will be recorded. Body weight, height, waist, and hip circumferences will be~     measured. Fasting venous blood samples will be obtained to determine hematological~     parameters [i.e., serum creatinine, total cholesterol, triacylglycerol, low density~     lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide~     dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein,~     tumor necrosis factor-alpha, and interleukin-6)]. Logistic regression analyses are going to~     perform to examine the relationship between areca nut chewing and MS in this population. If~     we can make sure the relationship between areca nut chewing and MS, the clinicians and~     nutritionists can teach people to quit areca nut chewing in order to avoid the possibility~     of developing metabolic syndrome and cardiovascular disease.~   "
67369|NCT02175511|"~     Importance: Less than fifty percent of patients with hypertensive disease manage to maintain~     their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models~     are needed in order to improve BP management in patients with hypertension.~      Objective: To evaluate whether cloud BP system integrated with computerized physician order~     entry (CPOE) is useful for improving BP management as compared with traditional care.~   "
67370|NCT02175498|"~     The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female~     infertility.~   "
67371|NCT02175485|"~     Primary Objective:~      To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom~     Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar~     pollen exposure.~      Secondary Objective:~      To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom~     Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about~     efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar~     pollen exposure.~   "
67372|NCT02175472|"~     Light treatment was originally employed in Parkinson's disease (PD) to determine if it might~     be effective in treating co-existing symptoms of depression and insomnia. However, a~     preliminary double-blind study as well as other studies reported significant improvement in~     both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study~     has validated these findings. This study will use a double-blind design to evaluate the~     safety and efficacy of a non-invasive light therapy device to be used with ongoing~     pharmacotherapy for PD, over a six month treatment period.~   "
67373|NCT02175459|"~     Regeneration of mature cells that produce functional insulin represents a major focus of~     current diabetes research aimed at restoring beta cell mass in patients with most forms of~     diabetes. The capacity to adapt in response to diverse physiological conditions during life~     and the consequent ability to cope for increased metabolic demands is a distinctive feature~     of the endocrine pancreas in the regulation of glucose homeostasis. Both beta and alpha~     cells are dynamically regulated to continually maintain a balance between proliferation,~     neogenesis, and apoptosis. In this proposal, the investigators will focus on exploring key~     mechanism(s) that potentially regulate islet cell plasticity in altered glucose metabolic~     states.~      Investigators will explore in a unique cohort of individuals who undergo duodenal~     pancretectomy. Prior to their surgery will be performed in vivo studies (Hyperglycemic~     clamp, Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests) to accurately assess glucose~     homeostasis parameters to classify each individual into metabolic phenotypes. Then exploit~     the opportunity to collect pancreas samples from these patients who will be evaluated again~     after surgery, the investigators will determine the ability of the remnant pancreas to~     compensate for the acute reduction in islet mass and perform correlations between ex vivo~     and in vivo parameters.~      Specifically, the patients will be subjected to incretin secretion (mixed meal), metabolic~     status (OGTT), insulin secretion characteristics (first and second phase responses), β-cell~     insulin content evaluation (arginine bolus). Subsequently, pancreas samples will be~     evaluated for morphometry, and proteomics and gene expression analyses of islet cell samples~     obtain by laser capture will allow a detailed investigation of mechanisms that contribute to~     islet plasticity. The overall goal of this project is to investigate key mechanisms driving~     the ability of islet mass to adapt to diverse metabolic states. We aim to explore~     modifications in gene expression and proteomics and correlate them with specific metabolic~     phenotypes, in order to determine key regulators of islet morphology.~   "
67375|NCT02175433|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or~     relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also~     be assessed.~   "
67376|NCT02175420|"~     The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.~      Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have~     non-specific effects on the innate immune system and is in epidemiological studies~     associated with reduced mortality due to infectious diseases.~      Several studies have shown that BCG can boost the effect of other vaccines. The present~     study aims to investigate the boosting effect of BCG on the response to typhoid fever~     vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at~     early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14~     days later.~      The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better~     vaccination result in terms of antibody production will be accomplished against typhoid~     fever due to the effects of BCG on the innate immune system.~   "
67377|NCT02175407|"~     The purpose of this study to explore the effect of multiple oral doses of itraconazole on~     the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study~     will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in~     combination with itraconazole.~   "
67378|NCT02175394|"~     The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the~     steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the~     components of Microgynon®~   "
67379|NCT02175381|"~     The investigators propose to study the safety and efficacy of the combination of Carboplatin~     plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.~   "
67380|NCT02175368|"~     Investigation on the clinical performance of a new dental adhesive when used in direct~     filling therapy after phosphoric acid etching.~      Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good~     filling quality.~   "
67381|NCT02175355|"~     Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are~     more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure~     (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response~     relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80~     mg.~      Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability~     of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations,~     heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity~     of adverse events.~   "
67382|NCT02175342|"~     This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal~     dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks~     in patients with COPD.~   "
67383|NCT02175329|"~     60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered~     with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The~     goal is to compare clinical survival , biological or technical behaviour of the~     restorations.~   "
67384|NCT02175316|"~     This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset~     muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC~     count, CRP count, CPK count, and pain tolerance.~   "
67385|NCT02175303|"~     To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and~     inflammation, with special focus on allogeneic hematopoietic cell transplantation patients.~     The hypothesis to be tested is that the cells are safe to infuse and that they have an~     anti-inflammatory and healing effect.~   "
67386|NCT02175290|"~     Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common~     dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion~     of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of~     MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of~     this study is to describe the clinical phenotype and genotype of the Yemenite Jewish~     subpopulation with MJD living in Israel~   "
67387|NCT02175277|"~     This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160~     study for the treatment of anaemic subjects with MDS. Subjects that complete the~     active-treatment period of the darbepoetin alfa MDS 20090160 study and meet the eligibility~     criteria may be enrolled into this study to continue treatment of darbepoetin alfa for up to~     73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.~   "
67388|NCT02175264|"~     In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the~     occurrence of novo mutations (dominant or recessive). Our objective is to test this~     hypothesis by combining the search for pathogenic genomic alteration and intragenic~     mutations through whole exome sequencing in a homogenous group of patients.~   "
67389|NCT02175251|"~     Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia.~     Almost a quarter of patients are medication resistant to such symptoms. The application of~     rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported~     successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an~     easier treatment for out-patients with schizophrenia compared to low stimulation treatment.~   "
67390|NCT02175238|"~     The primary objective of this trial is to investigate the relative bioavailability and~     pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with~     and without food in healthy male subjects.~   "
67391|NCT02175225|"~     The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate,~     improves the outcome of patients with brain hemorrhage.~      The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of~     sufficient promise to improve outcome before pursuing a larger clinical trial to examine its~     effectiveness as a treatment for intracerebral hemorrhage.~   "
67392|NCT02175212|"~     The present study is a phase III randomized and multicentric trial evaluating the potential~     additional impact effect of two years adjuvant androgen deprivation when combined with~     neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk~     prostate cancer patients. Stratification will be performed by prognostic factors and by~     participating institution.~   "
67393|NCT02175199|"~     The purpose of this study is to evaluate the comfort of color contact lenses in a population~     of clear contact lens wearers who have an interest in wearing color contact lenses.~   "
67395|NCT02175173|"~     This surveillance's objectives are~        1. Unknown adverse reactions~        2. Incidences of adverse drug reaction~        3. Efficacy during long-term administration~        4. Factors considered to have effect to safety and effectiveness~        5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and~          central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)~   "
67396|NCT02175160|"~     Several studies exist on patient performance in drive simulators especially around and after~     surgery. Recommendations concerning the ability to drive preoperatively are based on these~     studies, which generated their data using drive simulators. However, in all the datasets~     driving performance remains highly individual. Since a drive simulator is not readily~     available in normal general practitioner surgeries it would be helpful to have convenient~     clinical tests to evaluate a patients individual ability to perform an emergency stop. This~     study aims at evaluating different possibilities how such performance might be predicted.~     Patients with knee osteoarthritis and patients who have received total knee arthroplasty are~     tested clinically and their results are compared with the gold standard experiment - a drive~     simulator.~   "
67397|NCT02175147|"~     Rationale: Palliative care integration in treatment pathways, palliative care networks and~     institutional collaborations in health services delivery seems a promising approach reducing~     fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are~     largely unknown and under-investigated. The investigators aim is to explore experiences of~     patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic~     Heart Failure (CHF), family and professional caregivers within with IPC. This includes~     perceived quality of life, quality of care, burden/rewards of care giving, symptoms and~     collaboration between caregivers in the patient's care network.~      Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and~     professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary,~     The Netherlands and United Kingdom experience care delivery in the last phase of disease.~        -  To investigate what opinions patients and family caregivers have on the (continuity~          and) quality of care delivered~        -  To investigate how patients rate their symptoms and quality of life~        -  To investigate how family caregivers rate their burden / rewards of care giving~        -  To investigate how the care network of the patient is organised with respect to the~          type, properties and quality of relationships between patients and family /~          professional caregivers~      Study design: Longitudinal multiple embedded case study.~      Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC~     initiatives in five participating countries, their family and professional caregivers. The~     investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional~     caregivers in total.~      Study parameters: Experiences with IPC initiatives, quality of care, quality of life,~     perceived symptoms, perceived collaboration between professional caregivers, burden and~     rewards of care giving.~      Methods: Semi-structured interviews, patient diary, Social Network Analysis and the~     following questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction~     Assessment. Patients and family caregivers will be followed over 3 months at 4 consecutive~     contact points. The diary (containing two questions) will be kept weekly by patients. There~     will be group or individual interviews with professional caregivers.~      Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative~     data. For more information see Detailed Description.~   "
67398|NCT02175134|"~     The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent~     on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for~     diagnosing TBP shows has given promising results. The investigators thus created a 2-step~     algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites~     for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as~     a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the~     randomized controlled trial on whether this 2-step algorithm-based approach can reduce the~     laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP.~   "
67399|NCT02175121|"~     This study is going to assess the safety and tolerability of PF-06291874 in adults with Type~     2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control~     in these subjects.~   "
67400|NCT02175108|"~     This study aims to fill a gap in the literature, identify relevant clinical measures, and~     provide insight into the independent modifiable risk factors of obesity in the CP population~     with the long-term goal of improving screening, management and prevention of obesity in this~     at-risk and underserved population.~   "
67401|NCT02175095|"~     Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have~     been progressed after standard therapies, however, there has not been a predictive~     biomarker. The investigators designed this study to investigate whether [18F]FLT-PET might~     paly a role as a predictive imaging biomarker of treatment responses to regorafenib.~   "
67402|NCT02175082|"~     The purpose of this study is to assess the effectiveness of a forced exercise aerobic~     exercise program, utilizing a cycling activity, on specific gait parameters and balance in~     individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control,~     evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H&Y)~     stage II or III. Intervention: Participants randomly assigned to one of two exercise groups,~     forced exercise or self selected exercise, on cycling machine three times a week for 8~     weeks. Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80%~     heart rate max. Outcomes: Gait parameters of step length, width, and variability as measured~     by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via~     Patient Reported Outcomes Measurement Information System (PROMIS) scale.~   "
67403|NCT02175069|"~     Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for~     surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many~     institutions worldwide. Local anesthetic is being injected around the nerves supplying the~     arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles,~     thus called interscalene plexus block). The optimal volume of injection with regard to~     efficacy, safety and avoidance of untoward effects has been subject to intense debate for a~     long time. In spite of evidence that small volumes (between 5 and 7 mls) are effective for~     adequate postoperative analgesia, larger volumes up to 40 mls are still frequently used in~     many practices. However, with the use of such large doses, adverse events are known to occur~     with increased frequency, including paralysis of the diaphragm or spread of local anesthetic~     to the spinal cord.~      This study is intended to help evaluate the effects of small or larger injection of local~     anesthetic around the brachial plexus, and to correlate the distribution with clinical~     efficacy, block duration, and possible side effects. It is a randomized, controlled,~     observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly~     allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus~     block. Magnetic resonance imaging will be performed immediately afterwards, followed by a~     series of neurological exams during the hospital stay. Test of lung function (spirometry)~     and ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory~     mechanics.~   "
67404|NCT02175056|"~     The study design of this trial is a Dose-Block Randomized, Placebo controlled~     (Double-blind), Active Controlled(Open-label), Dose-escalation.~   "
67405|NCT02175043|"~     1. Purpose of the study~      1) To compare clinical outcome, procedure time, complication rate of persistent atrial~     fibrillation patients between conventional additional linear ablation and additional complex~     fractionated atrial electrogram targeted catheter ablation.~      2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. However, there are no consensus for proper ablation strategy in longstanding persistent~          atrial fibrillation.~        5. additional ablation make extent of myocardial injury and paradoxically increase~          recurrence rate, thus still controversial.~        6. Therefore, we will compare conventional linear ablation with additional complex~          fractionated atrial electrogram targeted catheter ablation.~      3. Methods~        1. Treatment of All patients with atrial fibrillation is performed according to the~          standard treatment guideline of atrial fibrillation.~        2. there is no additional blood sampling, imaging study, or any other invasive procedure~          according to the inclusion of the study.~      4. study contents~        1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation~             -  compare conventional linear ablation with additional complex fractionated atrial~               electrogram targeted catheter ablation. both strategies are conventional ablation~               strategies being performed world-wide.~        2. compare complex fractionated atrial electrogram before and after linear ablation.~   "
67406|NCT02175030|"~     This study is a randomized trial of two IUDs for emergency contraception: the copper IUD,~     the most effective method of emergency contraception vs. the levonorgestrel IUD, the most~     preferred IUD which has never been tested as an emergency contraceptive. This research has~     the potential to increase use of highly effective contraception in a high-risk population~     and lower the persistently elevated rate of U.S. unintended pregnancy.~   "
67407|NCT02175017|"~     The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects~     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy~     and resistant to a platinum-based chemotherapeutic regimen.~   "
67408|NCT02175004|"~     This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in~     patients with Familial Amyloid Polyneuropathy.~   "
67409|NCT02174991|"~     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5%~     and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are~     facing surgical intervention. Patients will be treated for 6 months in this initial trial.~      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the~     necessity of surgical intervention.~   "
67410|NCT02174978|"~     The proposed study is a Phase 1 study with controlled human malaria infection (CHMI)~     designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system.~     AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant~     manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes~     mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21.~     The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition~     to safety.~   "
67411|NCT02174965|"~     The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.)~     femoral component has a predictable and stable migration pattern (mean migration of the~     femoral component in three-dimensions,in mm) over a three year period, compared to a~     conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study~     are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable~     and stable migration pattern over a three year period and to measure the linear wear of~     femoral head into the ECIMA Highly Cross-linked polyethylene.~   "
67412|NCT02174952|"~     Therapist-led parenting interventions have been shown to reduce symptoms of attention~     deficit hyperactivity disorder (ADHD) and are recommended as a first line treatment for~     school age children with ADHD. However, parenting interventions can be costly and~     impractical for parents due to factors such as time constraints and travelling costs. A~     self-help parent training manual has been developed and initial results have shown moderate~     reductions in ADHD symptoms, indicating that whilst self-help may offer a cost effective~     alternative to therapist led parent training interventions, it may not be sufficient to~     treat ADHD alone. This study therefore aims to compare the efficacy and additional benefits~     of the self-help intervention plus treatment as usual including pharmacotherapy with a~     control treatment as usual group . Families with a child aged 6-10 with a clinical diagnosis~     of ADHD will be recruited to the study via referrals from community paediatricians and child~     and adolescent mental health services. After gaining informed consent subjects will be~     randomised to self-help plus Treatment as usual (TAU) + or TAU (control). Those allocated to~     TAU+SH will be issued with the self-help manual and an introductory DVD to highlight key~     aspects of the intervention. Self-help intervention will last for 12 weeks. Data will be~     collected via standardised questionnaires completed by the parent, teacher and child and a~     recorded speech samples from the parent. Data will be collected at three time points;~     pre-intervention, post-intervention (12 weeks) and as a long term follow up (28 weeks).~     After completing the trial, qualitative data will be collected about participants'~     experience of self-help intervention.~   "
67413|NCT02174939|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are~          inversely associated with coronary risk factors and atherosclerotic diseases such as~          coronary artery disease (CAD) and cardiovascular high risk.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and endothelial function as well as the potential~          mechanisms of action in patients with CAD and cardiovascular high risk.~   "
67414|NCT02174926|"~     The purpose of this study is to find out whether elective sigmoid resection will improve~     quality of life compared to conservative treatment with lifestyle guidance and fiber~     supplement in patients with a recurrent or complicated diverticulitis.~   "
67415|NCT02174913|"~     BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS~     can reduce total propofol dose when being used with TCI.The objective is to compare~     awakening time after spine surgery between using clinical signs and bispectral index (BIS)~     guided target controlled infusion(TCI) of propofol in patients having neurophysiologic~     monitoring.~   "
67416|NCT02174900|"~     The purpose of this study is to evaluate the tolerability and safety of increasing doses of~     primaquine in combination with artemether-lumefantrine in G6PD deficient males with an~     asymptomatic P. falciparum malaria infection.~   "
67614|NCT02172313|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food~     on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in~     a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three~     different dosing conditions in healthy subjects.~   "
67615|NCT02172300|"~     Study to investigate whether tiotropium therapy can increase duration of steady-state~     exercise by decreasing dynamic and static lung hyperinflation in COPD patients.~   "
67417|NCT02174887|"~     The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold~     standard since the end of the 90s' is gemcitabine; unfortunately all trials testing~     combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to~     demonstrate any superiority over gemcitabine monotherapy.~      In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel~     in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an~     impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week~     for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy,~     nausea, haematological side effects). This efficacy can be related to an improvement of~     gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in~     xenografts was better with the combination; this improvement was associated with an increase~     of intratumoral gemcitabine concentration in mice receiving the combination when compared to~     mice receiving gemcitabine alone. This might be associated to modifications of peritumoral~     stroma with reduction of stromal content and increase in dilated vessels.~      The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine~     induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor~     and of liver metastases after 2 cycles of treatment by comparison to baseline.~   "
67418|NCT02174874|"~     In children aged 3 months to 10 years who present to the Pediatric Emergency Department~     (PED) with recent, significant vomiting and moderate dehydration, is treatment with~     Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with~     Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT~     will have 10% less vomiting within 15 minutes of administration than those receiving~     Ondansetron OS.~   "
67419|NCT02174861|"~     To assess the long-term safety and efficacy of AMG 334 .~   "
67420|NCT02174848|"~     Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only~     patients who have completed the earlier study TIRCON2012V1 (a double-blind~     placebo-controlled trial in which participants were randomized to receive either deferiprone~     or placebo for 18 months) are eligible to enroll.~   "
67421|NCT02174835|"~     To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786~     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy~     volunteers.~   "
67422|NCT02174822|"~     To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786~     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine~     and between AVP-786 and duloxetine.~   "
67423|NCT02174809|"~     Excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and~     their offspring, and in 2011, 59 % of women in Nova Scotia gained weight in excess of~     recommendations. A number of factors influence how much weight a woman gains, including lack~     of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income,~     and education. Although a clinician's advice also plays a role, simply giving advice does~     not necessarily translate into patient behaviour change. On the other hand, advice that is~     given through a patient-centred approach is significantly associated with increased patient~     acceptance of and adherence to recommendations, and increased intentions and attempts at~     behaviour change. In addition, this approach has been shown to decrease costs to the health~     care system. Patient-centredness can measured from the perspective of the clinician, an~     observer, or the patient. Research suggests that the patient's perspective of~     patient-centredness is the perspective most significantly associated with improved health~     outcomes.~      Clinicians avoid discussing weight-related matters for a number of reasons, including a lack~     of time and general discomfort in raising the subject. There are some tools that can address~     some of these barriers, and example being the 5As of Obesity Management. This tool is~     based on principles of behaviour change science and patient-centredness. Pilot data on the~     use of this tool showed a two-fold increase in the initiation of weight-related discussions~     between clinicians and their patients. Our team was instrumental in the development,~     dissemination and initial evaluation of this tool, and Dr. Piccinini-Vallis has recently led~     a national multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the~     5As of Healthy Pregnancy Weight Gain tool. It is now time to evaluate whether the use of~     this tool is acceptable to clinicians and whether its use translates into any patient~     outcomes.~   "
67424|NCT02174796|"~     this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or~     orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction~     (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the~     cardiac output difference before and after intervention, measured by transthoracic~     impedancemetry, during an exercise stress test~   "
67425|NCT02174783|"~     Many metabolic complications can develop after liver transplant including: diabetes, high~     blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the~     safety and effect of 2 well known and established diet regimens on the people who had a~     prior liver transplant and investigate whether it helps with the control of these~     comorbidities.~   "
67426|NCT02174770|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet,~     leads to beneficial changes in muscle at low resistance and minimal stress on the nearby~     joint. This novel resistance training has the potential to greatly improve extremity muscle~     strength gains for rehabilitation patients who are unable for medical reasons to perform~     high resistance exercise. Our study will explore this with specific rehabilitation~     populations: post-operative knee scopes, post-operative anterior cruciate ligament (ACL)~     reconstruction patients who have acute post-operative changes in thigh muscle function and~     chronic thigh weakness. The primary outcome is to achieve accelerated functional thigh~     recovery with outcome measures including thigh strength, validated questionnaires, and~     validated functional testing. Occlusion training can enhance rehab patients outcomes, reduce~     the cost of care, and improve the skills and efficiency of care providers.~   "
67427|NCT02174757|"~     Periodontitis is a multifactorial disease that can lead to the destruction of supporting~     tissues of the teeth resulting in pocket formation, recession or both. Since the primary~     etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm,~     efforts for disease prevention and treatment are mainly focused on pathogen reduction and~     strengthening of epithelial barrier, thus contributing to decreased susceptibility to~     infection. Due to emergence of antibiotic resistance and frequent recolonization of treated~     sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced~     to periodontal disease. The need was fulfilled by the introduction of Probiotics and~     Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning for~     life are microorganisms proven to exert health promoting influences in humans and animals.~     Food and Agriculture Organization and WHO have stated that there is potential for probiotic~     foods to provide health benefits and that specific strains are safe for human use.~   "
67716|NCT02170987|"~     To investigate if dabigatran has a clinically relevant impact on the cardiac~     electrophysiology that is manifest as prolongation in QT-interval.~   "
67428|NCT02174744|"~     The pain of the elderly is often trivialized and ignored in spite of its high frequency: the~     chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in~     institution and 80 % of this population at the end of life.~      The evaluation of pain appeals to the same strategy as to the younger subject but with some~     specificities, related more to the pathologies associated with the ageing than to the real~     age. For that purpose, the investigators have self-assessment scales as the Numeric Pain~     Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a~     bias because, some patients do not express spontaneously their pain.~      So behavioural scales were elaborated to solve the difficulties of detection and to care the~     pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be~     completed) whose objective is the observation of behavioural changes caused by the acute~     pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in~     few minutes a good evaluation of pain) whose objective is the observation of behavioural~     changes caused by the chronic pain in elderly having communication impairments.~      In practice, because of its popularity, the Algoplus® scale is widely used out of the~     specificity in which it has been validated. Practitioners, worried about this misuse,~     suggested to Doloplus® group, to test the concordance between the two behavioural scales in~     order to develop recommendations more targeted. The risk is that the use of the Algoplus®~     scale may underestimate pain that would have been detected by Doloplus® scale, and lead to~     under-treatment or non-treatment of pain in elderly having communication disorders.~      This study aims to establish the concordance between these two scales to generate advices~     and recommendations to assess efficiently the pain in this vulnerable population.~      The main objective of this study is to assess whether the use of Algoplus® scale is in good~     concordance with Doloplus® scale.~      The secondary objective of this study is to assess the concordance with different levels of~     Algoplus® pain scale: (0-1), (2-3), (4-5).~   "
67429|NCT02174731|"~     The purpose of this study is to evaluate the safety and efficacy of roxadustat compare to~     epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.~   "
67430|NCT02174718|"~     A clinical need exists for non-oral vitamin D administration. This study is designed to test~     a new proprietary transdermal system. It is looking to see if this new system will safely~     and successfully deliver vitamin D3 to humans.~   "
67431|NCT02174705|"~     This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to~     sugar water for reducing vaccine injection pain in infants.~   "
67432|NCT02174692|"~     The aim of this study is to understand how healthy muscle repairs in response to eccentric~     exercise by evaluating functional, metabolic and molecular measures. Furthermore, this study~     will aim to understand the repair mechanisms in elderly healthy muscle following eccentric~     exercise by evaluating the same measures and highlighting age-related differences in repair~     mechanisms which may account for the age-related loss in muscle mass. It is hypothesised~     that elderly muscle will have a lesser/ blunted repair process compared to young muscle.~      To meet the aims of this study and to answer the hypothesis, this study protocol is as~     follows:~      Baseline functional, metabolic and molecular values are obtained via functional testing and~     a muscle biopsy. Participants then perform eccentric exercise designed to induce functional~     decline and muscle soreness and the contralateral leg performs concentric exercise which~     isn't designed to induce soreness or functional decline. Using a time-course, various~     metabolic and molecular measures are taken prior to and up to 7 days post exercise to~     understand the mechanisms underlying muscle repair. In addition the use of a novel amino~     acid tracer (D2O) will allow for synthesis measures over the duration of the study rather~     than the typical tracer techniques which only capture ~12 hours of synthesis.~   "
67433|NCT02174679|"~     To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine~     tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.~   "
67434|NCT02174666|"~     The aim of the project is to execute a double-blind, parallel, randomized 12-month~     intervention trial on postmenopausal women with osteopenia (low bone mineral density), in~     order to determine the effects of daily intake of fermented red clover (RC) extract on~     estrogen dependent bone mineral resorption when compared to placebo. Both groups will~     recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also~     assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular~     disease.~   "
67435|NCT02174653|"~     The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term~     (4 months) medication. The protective effects of EPs®7630 and its effects during a cold~     episode will also be studied.~   "
67436|NCT02174640|"~     The primary objective is to test if acute supplementation with Coffee would improve~     antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat~     meal in over weight/ obese humans.~      Secondary objective is to determine the ability of coffee to modify postprandial~     inflammation in overweight/ obese humans.~   "
67437|NCT02174627|"~     The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment~     of anemia in patients with chronic kidney disease not on dialysis.~   "
67438|NCT02174614|"~     The investigators are conducting a randomized clinical trial of rapid abstinence initiation~     and cognitive control training as a precursor to our new web-based version of the CBT4CBT~     (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its~     effectiveness relative to standard outpatient counseling at the Midwestern Connecticut~     Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and~     inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching~     basic coping skills, presenting examples of effective use of coping skills in a number of~     realistic situations in video form, and providing opportunities for patients to practice and~     review new skills while receiving cocaine abuse treatment.~   "
67439|NCT02174601|"~     After written consent for participating in clinical research studies, all clinical studies~     conducted to in the one day. The investigators will ask and record about bowel cleansing~     state in all patients who performed colonoscopy. There is no additional cost and the~     expected complications.~      Based on answer, the investigators will develop a prediction model for inadequate bowel~     preparation and prove validation. This model can take the additional measures to subjects~     predicting improper cleansing. It can contribute to improve the accuracy of the test and~     reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost~     savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a~     improvement of the quality of management~   "
67440|NCT02174588|"~     Since introduction in 1989, propofol has gained wide acceptance for sedation during~     endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not~     established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation~     (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this~     study, the investigators want to compare the patient satisfaction with EGD following~     balanced propofol sedation (BPS) versus propofol sedation alone.~   "
67717|NCT02170974|"~     Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg~     BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph~     I in HPMC capsules~   "
67441|NCT02174575|"~     -  It has been shown that patients who undergo liver resection surgery are at high risk~          for postoperative acute kidney injury (AKI).~        -  Sevoflurane may increase the risk for postoperative AKI because of production of~          compound-A.~        -  Therefore, we have planned to investigate the effects of different anesthetic agents on~          postoperative renal function.~        -  Patients undergoing liver resection surgery are randomized into 2 groups.~        -  One of the groups receives sevoflurane and the other group receives desflurane.~        -  Blood and urine specimen are sampled both pre- and postoperatively, and several~          biomarkers are compared between the groups.~   "
67442|NCT02174562|"~     This research aims to help older African Americans with diabetes and mild memory problems~     improve how they take their medications and control their diabetes. This may preserve their~     independence and health, prevent cognitive and functional decline, and reduce health care~     costs. As the population ages and becomes more racially diverse, finding ways to achieve~     these outcomes has great public health importance.~   "
67443|NCT02174549|"~     This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating~     agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer~     patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4~     nodules are eligible. Tirapazamine will be given by intravenous infusion in the first two~     cohorts and then switched to intra-arterial injection before embolization in subsequent~     cohorts. Treatment effect is evaluated by MRI based on modified RECIST criteria. Repeat~     treatment is necessary only if disease progression. Each patient is allowed to have up to 6~     treatments in a 18-month period.~   "
67444|NCT02174536|"~     A prospective double blind randomized study comparing placenta derived decidual stromal~     cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell~     transplantation. It is hypothesized that the decidual stromal cell therapy will be superior~     to placebo.~   "
67445|NCT02174523|"~     To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of~     40 mg lurasidone in healthy Chinese subjects.~      To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone~     in healthy Chinese subjects.~   "
67446|NCT02174510|"~     To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral~     administration of different doses in healthy Chinese subjects.~      To evaluate the safety and tolerability of lurasidone after single oral administration of~     different doses in healthy Chinese subjects.~   "
67447|NCT02174497|"~     This was a blinded study conducted on the efficacy and safety of a one-day versus a~     three-day bowel preparation in a pediatric population. Limited data is available in this~     regard, and this study supports the use of a one-day bowel preparation, as this is both safe~     and effective.~   "
67448|NCT02174484|"~     The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature~     (intracardiac electrogram) to provide more extensive remote information about cardiac~     rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical~     action.~      PREMS is a non-interventional, prospective, and multicenter study. The primary objective is~     to assess the added clinical value of periodic IEGMs, based on the rate of patients with a~     rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring~     (HM) and non detectable so obvious on the other parameter set offered for the remote~     follow-up.~   "
67449|NCT02174471|"~     Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and~     the Western world. Surgery for severe AS prior to symptom onset is controversial.~     Conventionally changes in valve area and gradient are used to time intervention but~     myocardial changes may be more predictive of surgical need.~      This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker,~     implementing a novel, non-invasive MRI technique to measure it.~      Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with~     severe narrowing of the aortic valve before and one year after valve replacement. Expected~     outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after~     surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post~     operative morbidity and mortality, who may benefit from earlier valve replacement.~   "
67450|NCT02174458|"~     Body contouring (BC) surgery after major weight loss (MWL) requires extensive and multiple~     procedures. Yet, there are inconsistent data regarding the outcome after BC procedures. The~     aim of this study is to investigate the outcome from patients who elect to have BC~     procedures after MWL treated at a single metropolitan tertiary referral center.~   "
67451|NCT02174445|"~     This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to~     800 mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with~     confirmed MMR without MR4.5~   "
67452|NCT02174432|"~     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER~     tablets during a treatment period of up to 50 weeks.~   "
67453|NCT02174419|"~     The primary objectives of the study are to evaluate the effects of two doses of nalbuphine~     HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in~     patients with prurigo nodularis and to evaluate the safety and tolerability in the study~     population.~   "
67454|NCT02174406|"~     The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis~     (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and~     DBT.~   "
67455|NCT02174393|"~     Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults.~     Early treatment is imperative to reduce acne scarring which can appear with atrophic~     lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory~     hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the~     aforementioned types of lesions. Pharmacologic management is essential, but safe procedural~     therapies are also necessary specifically with darker skinned individuals.~      Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using~     a micro-needling device, which is safe and effective in causing micro-wounds into the~     dermis thereby initiating wound healing followed by collagen production. This is an ideal~     treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin~     types . Currently there are very few studies evaluating the safety and efficacy of~     microneedling and chemical peels in skin types III-VI.~      The aim of this study is to evaluate the effects of the combination of microneedling and~     chemical peel for the treatment of acne scars in skin types III-VI.~   "
67457|NCT02174367|"~     • Main objectives and outcome measures.~        1. Establish prevalence of and factors contributing to fatty liver disease and liver~          fibrosis in patients with psoriasis.~           Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy~          or non-invasive tests of fibrosis including transient elastography, ultrasound, serum~          markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).~        2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely~          transient elastography, standard liver function tests and P3NP.~        3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic~          syndrome on response to treatment in patients with psoriasis.~      Data on co-morbid disease collected through questionnaires and review of medical records.~     Response to treatment assessed using psoriasis area and severity index (PASI) physician~     global assessment (PGA) and dermatology life quality index (DLQI).~        -  Study population: 380 patients with moderate to severe psoriasis will be prospectively~          recruited to the study.~        -  Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine~          Smith~        -  Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and~          St Thomas Hospitals Trust~   "
67458|NCT02174354|"~     Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including~     psoriasis, where it is the recommended first-line systemic therapy in moderate-to-severe~     disease. Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and~     a significant number experience side effects that may include deranged liver enzymes. There~     is currently no validated test to predict how patients with psoriasis will respond to MTX,~     in terms of disease outcome and/or toxicity, or to guide dose escalation in this group.~   "
67459|NCT02174341|"~     This test is to be collected during the dengue outbreak samples, including samples back in~     the past and forward to close the case, investigating the prevalence of serum Chikungunya~     virus infection, and against those suspected dengue fever, Chikungunya disease-related tests~     conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to~     detect Chikungunya virus and then develop.~   "
67460|NCT02174328|"~     The main objective of this trial is to study the occurrence of preeclampsia in recipients of~     donated oocytes receiving aspirin at an early stage during pregnancy and to compare the~     results with those obtained in patients receiving placebo.~   "
67461|NCT02174315|"~     This study examines the impact of a culturally tailored version of contingency management~     treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives.~     Participants will be recruited from addiction treatment agencies and throughout the~     community. Those who complete a 4 week induction period will be randomized to receive 12~     weeks of contingency management or a non-contingent control condition. Individuals will then~     be followed for an additional 3-months to assess the long term efficacy of the treatment.~   "
67462|NCT02174302|"~     Comparison of Images of the same area in the bladder in four different SPIES modalities on a~     tablet computer. Participants are asked to delineate the area on the image suspect for~     malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s)~     is/are captured. Time to start the drawing and total time per image are captured. Hereafter,~     an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10~     being best possible.~   "
67463|NCT02174289|"~     Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic~     heart failure with well documented benefits in symptom improvement and reduction of~     morbidity and mortality. However, upto 30% of patients do not respond to treatment despite~     fulfilling the recommended indications. Lack of clinical response may be the result of~     imperfect left ventricular lead placement in the veins around the heart with conventional~     techniques. Optimum lead placement may constrained by coronary venous anatomy and may~     overlie scarred heart muscle or may not be at the site of latest electrical depolarisation.~     In a further 10% of patients, conventional left ventricular lead placement is not possible~     for other technical reasons.~      Left ventricular endocardial lead placement may overcome the limitations and allow placement~     to be guided by echocardiography, electrical mapping and the pattern of heart muscle~     scarring.~      We aim to investigate if targeted left ventricular endocardial lead placement improves~     exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency~     and biochemical markers of heart strain. Each parameter will be assessed independently and~     as part of a composite cardiac performance score.~      Patients with heart failure will be enrolled who require an endocardial left ventricular~     lead on clinical grounds as either conventional left ventricular lead implantation has~     technically failed or they have clinically non-responded to CRT.~   "
67464|NCT02174276|"~     This study is to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with~     chronic hepatitis B infection (CHB) and who are currently not on treatment. Participants~     will be randomized to receive tenofovir disoproxil fumarate (TDF) alone or GS-4774 plus TDF~     for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on~     TDF and will be followed for an additional 28 weeks. Following completion of the 48 week~     study period, all participants will be eligible for a 3 year registry study.~   "
67465|NCT02174263|"~     This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host~     disease (GVHD) in patients that have not responded to treatment after at least two prior~     therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By~     blocking this protein, the investigators may reduce the symptoms of chronic GVHD.~   "
67466|NCT02174250|"~     The purpose of this study is to test whether Rifampin affects blood levels of istradefylline~     in humans. Rifampin could possibly decrease istradefylline levels.~   "
67467|NCT02174237|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and~     female subjects~   "
67468|NCT02174224|"~     The purpose of this study is to determine if a hospital-based violence intervention programs~     can make sustainable behavior changes in at-risk youth using two key components, brief~     intervention at the hospital bedside and case management.~   "
67469|NCT02174211|"~     To study the effect of pars plana vitrectomy and posterior vitreous detachment on the~     intravitreal pharmacokinetics of ranibizumab~   "
67718|NCT02170961|"~     this study aim to investigate the:~        -  association of RAAS polymorphisms and AHF~        -  association of MMP 3 and 12 polymorphisms and AHF~   "
67470|NCT02174198|"~     This study compares two ways of placing a dental implant on the day of tooth extraction. One~     method will place a additional bone graft (derived from bovine bone) and the other group~     will not have the graft placed. Both groups will be restored at the same time with an~     immediate crown.~      The investigators will be researching and comparing the changes in gum level that occur~     after each surgical method, as well as changes in jaw width where the implant is placed.~      The investigators will enroll 16 patients per group. The patients will be followed for 3, 6,~     and 12 months post-immediate implant placement to observe healing.~   "
67471|NCT02174185|"~     The aim of this study is to compare the health-related quality of life (HRQoL) between~     patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The~     investigators plan to use validated HRQoL questionnaires to learn about how the different~     urinary diversion operations affect the HRQoL of people living with bladder cancer. The~     findings from this study may help doctors and patients choosing the proper operation type.~   "
67472|NCT02174172|"~     This global, multicenter, open-label study will evaluate the safety and tolerability of~     MPDL3280A in combination with other immune-modulating therapies in the treatment of selected~     advanced or metastatic malignancies. The MPDL3280A plus ipilimumab arm (Arm A) will focus~     primarily on patients with advanced or metastatic NSCLC. The MPDL3280A plus interferon~     alfa-2b arm (Arm B) will enroll patients with advanced or metastatic RCC and melanoma.~     MPDL3280A will be administered intravenously every 3 weeks (q3w).~   "
67473|NCT02174159|"~     The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral~     activity of a single dose of MK-8507 in antiretroviral therapy (ART)-naive, HIV-1 infected~     participants. The hypothesis tested in the study is that at a safe and well-tolerated dose,~     MK-8507 has superior antiretroviral activity to a historical placebo control, as measured by~     change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.~   "
67474|NCT02174146|"~     1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?~        2. Does their level change after periodontal therapy?~   "
67475|NCT02174133|"~     End stage heart failure is characterized by a critical inability of the heart to meet the~     organism's blood demand even under resting conditions. Heart transplantation (HTx) is the~     established therapeutic approach in the treatment of end stage heart failure and still the~     gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital~     therapeutic option to temporarily or permanently assist the failing circulation. The~     hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The~     aim of the study is to investigate the effect of LVAD implantation compared to heart~     transplant (HTx) on micro- and macrovascular function in patients with end stage heart~     failure.~   "
67476|NCT02174120|"~     To explore the application of target controlled infusion of etomidate combined with propofol~     in the maintenance of anesthesia during brain surgeries.~   "
67477|NCT02174107|"~     The purpose of this study is to evaluate cost-utility analysis in order to provide~     recommendations to French decision-makers between vertebroplasty and radiation therapy in~     Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The~     object of this study would be to expand the use of vertebroplasty.~      Moreover, this study assess to the strategy impact on the pain control reduction and~     functional preservation. In fact, analgesic effect is achieved differently depending on the~     procedure used.Eligible patients will be recruited and registered consecutively. Patients~     will be randomly,~      This is a health-economic multicenter, prospective, randomized with stratification according~     to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :~        -  Arm A: Percutaneous vertebroplasty~        -  Arm B: External radiotherapy~      This is an open-label study. The expected total study period is 2.5 years (enrolment: 2~     years, patient follow-up: 6 months). A total number of 304 patients with spine metastases~     will be recruited (152 patients/arm).~   "
67478|NCT02174094|"~     The purpose of this study is to investigate the effect on the frequency of tonic-clonic and~     clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of~     treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.~   "
67479|NCT02174081|"~     ARDS is a severe disease, it's important to predict the incidence of ARDS.~   "
67480|NCT02174068|"~     Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a~     significant percentage of patients disclaim little or no pain relief with common analgesics,~     specific or not their type of pain. This is especially true in cases of chronic pain, and~     current treatments are associated with many side effects. A need for therapeutic innovation~     is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its~     excellent safety, its analgesic effect is limited from moderate to severe pain. Many~     analgesic drug combinations include paracetamol, recently the co-administration of~     paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et~     al. 2013). The development of a formulation associating paracetamol and nefopam first~     requires searching a possible pharmacokinetic interaction between the two active substances~     and assessing safety of this combination in healthy volunteers. No published studies~     providing such information.~   "
67481|NCT02174055|"~     The purpose of this study is to develop an accurate and useful way of measuring older~     patients' moods and reactions to the combined issue of cancer treatment and aging.~   "
67482|NCT02174042|"~     The aim of this retrospective study is to review and describe safety and efficacy of Tang~     Ning Tong Luo capsule.~   "
67490|NCT02173938|"~     Our overall research goal is to determine how these novel psychosocial factors impact~     cessation. This pilot study will answer how dual use of other tobacco products, direct to~     consumer marketing, and the new phenomenon of butting-out and relighting influences~     cessation, and how understanding impulsivity and task persistence could lead to new and~     improved behavioral interventions for tobacco dependence. Answers to these pilot questions~     will lead to the publication of several manuscripts and provide important feasibility data~     to design large, well-powered clinical trials, population-level epidemiological studies, and~     contribute to furthering the field of tobacco treatment.~   "
67667|NCT02171624|"~     Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a~     randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate~     alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and~     the pharmacokinetic interaction between quinidine and dabigatran etexilate.~   "
67483|NCT02174029|"~     When a person is put on a breathing machine the investigators think that the breathing~     muscles can get weaker. The investigators are not sure how quickly this happens but in some~     people this leads to problems when they try to breathe on their own without the breathing~     machine. The diaphragm is at the bottom of a person's chest separating their lungs from what~     is in their belly and it is a very strong muscle. In fact, it is main muscle that one uses~     for breathing.~      An ultrasound machine is a painless way to see what is happening beneath the skin. It is~     safe and easy to do. Using an ultrasound the investigators are planning to measure how thick~     the diaphragm is and how much it changes while a person is on a breathing machine in the~     ICU.~      Getting a better understanding of this condition could lead to improved treatments that~     might help support patients who require a ventilator for breathing.~      The investigators hypothesis is that patients for whom the breathing machine is doing all of~     the work of breathing, will have their diaphragm thickness gradually decrease and changing~     to a breathing modem mode where they have to put in more effort the diaphragm thickness will~     start increasing again.~   "
67484|NCT02174016|"~     This is a prospective pilot study evaluating the safety and feasibility of implementing the~     ketogenic diet in children admitted to the pediatric intensive care unit with acute brain~     injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies~     suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is~     impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in~     clinical practice for the treatment of medication resistant epilepsy and is intended to~     switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their~     standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive~     low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be~     detectable through serum tests and MRI spectroscopy studies of the brain within several days~     of diet initiation, and that there will be a low incidence of side effects and adverse~     events,~      Measures of interest will include the incidence of kidney stones, excessive acidosis and~     excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy~     trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a~     type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies~     within the brain will be measured through MRI spectroscopy sequence which will be acquired~     at the same time as a follow-up MRI brain study ordered for clinical purposes.~   "
67485|NCT02174003|"~     This protocol will allow for the implementation of a research registry pertaining to Whole~     Body Hyperthermia (WBH) use in various subject populations. The primary objective of the~     proposed study is to determine if WBH can have beneficial effects in various subject~     populations currently experiencing numerous other comorbidities, and the duration of the~     effect(s).~      This protocol is intended to become a secondary resort for individual's interested in~     receiving a Hyperthermia treatment for potential beneficial gain related to symptoms~     stemming from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal~     symptoms, arthritis, etc). Due to the fact that no external research funding has been~     acquired for this broad application this protocol is intended to charge a fee for cost~     covering purposes only.~      The registry trial will not be limited to only include individuals with major depressive~     disorder, however, this protocol will allow for an expanded use in all populations (while~     still excluding subjects based on safety parameters). We will monitor subject's~     physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia~     treatment in an open fashion (no placebo/control condition). This registry study will~     include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.~   "
67486|NCT02173990|"~     The PULsAR trial is an international, investigator-initiated, single arm open-label phase II~     study. The aim of this study is to measure the clinical activity of the combination~     FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer,~     and treated with a FOLFIRI-aflibercept regimen as first line treatment.~   "
67487|NCT02173977|"~     The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation~     (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation~     characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible~     multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist~     protocol.~      The investigators hypothesized that combining the stimulatory effect of GnRH agonists and~     immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH~     strategy for IVF patients, resulting in improved ART outcome.~   "
67488|NCT02173964|"~     1. Background~             1. PET/CT (positron emission tomography/computed tomography) using FDG~               (fluorodeoxyglucose) is widely used for evaluation of cancer patients.~             2. Bowel uptake of FDG is a serious problem that hampers the proper reading of~               PET/CT.~             3. There is no widely-accepted method to reduce the bowel FDG uptake.~        2. Purpose~             1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce~               bowel uptake of FDG.~             2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.~             3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel~               contraction during PET/CT acquisition.~        3. Method~             1. Intervention versus control: administration of single tablet of pinverin (50mg)~               perorally versus simple water (~100mL).~             2. Timing of administration: At the time of FDG injection. PET/CT images will be~               acquired 1hr post FDG injection.~        4. Primary outcome~             1. SUV (standardized uptake value) difference between pinverin administered patient~               group versus control group.~             2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity~               in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)~   "
67489|NCT02173951|"~     A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50~     mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and~     with either appearance of LPI > 0.2 or TSAT reaches 50% compared with non treatment arm.~      So the aim of this study:~        1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg )~          which lead to Serum ferritin reaches 500 ng /ml and LPI appearance >0.2 as well as TSAT~          reaches 50 % .~        2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or~          prevent SF from reaching 1000 ng/ml or LPI >0.6 or TSAT >70% in comparison to patients~          not starting chelation therapy~        3. Determine adverse events whether drug or non drug related~   "
67491|NCT02173925|"~     The pathophysiology of functional dyspepsia is still unclear but several peptides have been~     indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of~     appetite and gut motility and serotonin is a typical neurotransmitter related with sensory~     and motor functions of gut. On the other hand, transient receptor potential vanilloid~     receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal~     disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or~     glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine~     whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric~     mucosa of FD patients are different from those in healthy controls, and whether some changes~     of their expression correlate with certain dyspeptic symptoms. The investigators also~     investigated the effect of H. pylori infection by comparing their expressions before and one~     year after H. pylori eradication.~   "
67492|NCT02173912|"~     This study is designed to evaluate the bioequivalence of the two treatments, the~     administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine~     besylate, in healthy volunteers.~   "
67493|NCT02173899|"~     The purpose of this study is to observe the occurrence of adverse events, seroconversion~     rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.~   "
67494|NCT02173886|"~     This study is being conducted to evaluate how the body absorbs and processes the sustained~     release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are~     1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls~     will also be enrolled based on a matching criteria to post gastric bypass subjects.~     Participants will be asked to complete two 12-hour study days approximately 11 days apart.~   "
67495|NCT02173873|"~     Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology~     (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml~     injection). The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml~     injection would cost 20 USD for patients. Animal studies showed the injection is safe,~     knowing that the rabbit vitreous volume is 3-4 times smaller than the human eye. Our pilot~     study is to ascertain if the approved molecule for oncology when injected in the eye is safe~     as it is diluted into 5ml vitreous (100 times dilution). If this is so then we can save the~     patient 100 times for the most efficient antiVEGF that is used for maculopathy in various~     diseases (AMD, DME, CRVO, etc..)~   "
67496|NCT02173860|"~     The purpose of this study is to determine whether, in patients undergoing elective valvular~     heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR~     (Fractional flow reserve) would be superior to standard angiography-guided-revascularization~     approach on major efficacy and safety outcomes~   "
67497|NCT02173847|"~     Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the~     surgical outcomes: minimally invasive procedures, improved biomechanical stability of the~     transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of~     infections risk, faster healing process.~      In order to achieve these goals, two different lasers were used during PK surgery:~        -  a femtosecond laser to cut an anvil shaped profile~        -  a diode laser to weld the surgical wound~   "
67498|NCT02173834|"~     In this study the investigators aim to investigate whether the sympathetic stimulation of~     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed~     tomography computed tomography scan, differs between lean and obese individuals, as an~     explanation for the diminished metabolic brown adipose tissue activity in obese subjects.~      The investigators hypothesis is that sympathetic nervous system activity in the obese is~     diminished as compared to their leaner counterparts as an explanation for the diminished~     metabolic brown adipose tissue activity in the obese.~   "
67499|NCT02173821|"~     This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily~     dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of~     anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No~     investigational medicinal product will be administered in connection with this follow-up~     study. Eligible patients will attend one visit in this follow-up study.~   "
67500|NCT02173808|"~     To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a~     single 20 mg dose of levonorgestrel butanoate (LB).~   "
67501|NCT02173795|"~     The primary objective of this study was to investigate patients acceptability / preference~     of Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol~     (MA) inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life~     conditions was also evaluated.~   "
67502|NCT02173782|"~     To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium~     bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which~     is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21~     µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile~     is at least as good when COPD patients are treated for 12 weeks.~   "
67503|NCT02173769|"~     The decrease in physical activity due to increasing dyspnoea that over time leads to a~     steadily worsening condition and increasing restriction of physical functioning is a key~     problem for COPD patients and affects even the early stages.~      Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a~     marked improvement in physical exercise capacity.~      However, there have so far been no data from the daily practice setting about everyday~     functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or~     Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2~     long-acting bronchodilators.~      The objective of this NIS is to measure changes in physical functioning as a surrogate for~     physical activity and exercise capacity in COPD patients on treatment with Spiriva®~     Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in~     routine daily treatment (so-called real life setting).~   "
67521|NCT02173522|"~     The purpose of this study is to determine whether pre-operative prostate artery embolization~     (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate~     cancer patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).~   "
67504|NCT02173756|"~     Chemotherapy kills tumor cells but can also damage healthy cells and cause significant~     digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient~     but their intensity may require special measures. Mucositis are painful and morphine gel or~     intravenous morphine is used to relieve pain.~      However, the pain of oral mucositis induced by chemotherapy is not completely relieved by~     morphine administered intravenously.~      As part of the study, the investigators want to evaluate an oral gel containing a small~     amount of morphine so that it acts directly on the mucositis. The investigators believe that~     the direct action of morphine on mucositis may be more effective on pain.~   "
67505|NCT02173743|"~     Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific~     tendinitis which does not respond to conservative treatment. NACD is effective in~     approximately 70% of the patients.When NACD is not effective, surgery is often the only~     treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for~     diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and~     the doctors treating those patients will benefit from a more effective minimal invasive~     treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering~     its positive effect on tissue repair, be a possible solution here.Previous research~     investigating the effects of PRP on other tendinopathies did, however, show controversial~     results. The aim of this double-blind randomized controlled trial is to investigate the~     effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder~     function, tendon recovery,resorption of calcific deposits, the percentage of patients with~     persistent complaints and quality of life.~   "
67506|NCT02173730|"~     To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of~     BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences.~     To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953~     ZW.~   "
67507|NCT02173717|"~     Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer~     rifampicin affects plasma exposure of dabigatran.~   "
67508|NCT02173704|"~     Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of Novartis~     Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly~     administered with routine vaccines in healthy infants in Taiwan.~   "
67509|NCT02173691|"~     The objective of this study is to compare the long-term (six month) bronchodilator efficacy~     and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo~     inpatients with COPD.~   "
67510|NCT02173678|"~     Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as~     compared to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive~     dosing in healthy male and female subjects~   "
67511|NCT02173665|"~     The objective of the current study was to investigate safety, tolerability, pharmacokinetics~     and pharmacodynamics of BI 1356 BS.~   "
67512|NCT02173652|"~     The objective was to investigate the influence of 2 different dosage regimens (5 mg once~     daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of~     orally administered BI 1356.~   "
67513|NCT02173639|"~     The objective was to assess the relative bioavailability of a pilot scale linagliptin 2.5 mg~     / metformin 1000 mg fixed dose combination (FDC) tablet in comparison with single tablets of~     linagliptin 2.5 mg and metformin 1000 mg administered together.~   "
67514|NCT02173626|"~     An eight week mindfulness training for physicians in a community hospital setting, largely~     administered through web-casts, will decrease stress and burnout, increase job satisfaction,~     and develop lasting mindfulness skills in the participants.~   "
67515|NCT02173613|"~     The main objective is to evaluate the interest of the repeated measurement of procalcitonin~     in patients with pulmonary infection to reduce the duration of antibiotic therapy in~     comparison with a conventional clinical strategy.~   "
67516|NCT02173600|"~     The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion~     activity. It is being implemented by the Andalusian Health Service to reinforce basic~     intervention advice on healthy diet and exercise. The IDC intervention is aimed at the~     prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and~     stroke).~      The main objective of the present study is to assess adherence to the IDC intervention and,~     consequently, its effectiveness on the prevention of the above mentioned diseases.~   "
67517|NCT02173587|"~     Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of~     100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling~     and arthritis index in rat model. In the present study, HMLE was processed to capsules under~     strict food safety supervision and patients with active rheumatoid arthritis (RA）were~     selected to examine whether supplementation with HMLE could improve clinical and laboratory~     parameters of disease activity. The validated disease activity score that include 28 joint~     counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary~     outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2~     were also measured to explore the mechanisms.~   "
67518|NCT02173574|"~     The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in~     combination and obtain initial safety data for co-administration of alisporivir and EDP239~     to support future treatment studies in patients. The purpose of Part 2 is to inform the~     drug-drug interaction potential of EDP239 more broadly and possibly facilitate the~     interpretation of lower than expected alisporivir concentrations in Part 1, if observed.~   "
67519|NCT02173561|"~     The purpose of this study is to conduct a randomized controlled trial to compare group and~     individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.~   "
67520|NCT02173548|"~     -  Heart Failure with Preserved Ejection Fraction (HFpEF) is a common form of heart~          failure~        -  Standard treatment for heart failure, show less than ideal results in HFpEF~        -  Evidence of systemic inflammation is common in all forms of heart failure, including~          HFpEF~        -  The main hypothesis of this study is that systemic inflammation contributes to heart~          failure symptoms and exercise limitations in patients with HFpEF~        -  The main objective is to treat patients with HFpEF and evidence of systemic~          inflammation with an anti-inflammatory drug targeting Interleukin-1 (or placebo) to~          determine effects on cardiovascular function~   "
67522|NCT02173509|"~     This is a cluster randomised controlled trial covering all general practitioners working in~     the National Health System (SNS) and all pharmacists working in community pharmacies in the~     area covered by the Health Region Administration of Center (ARS-C) . A specific educative~     intervention, designed from gaps detected in knowledge and attitudes with respect to~     antibiotics and resistance, will be carried out on the intervention group. The control group~     will not receive any specific intervention.~      Hypotheses:~        1. The attitudes and knowledge towards antibiotics generate habits of prescription by~          physicians~        2. The attitudes and knowledge towards to antibiotics generate propensity to dispense~          antibiotics without prescription by pharmacists~        3. The identification of the attitudes, knowledge and factors that generate habits of~          inadequate prescription will allow the design of specific educative interventions to~          improve the use of antibiotics~        4. The identification of the attitudes, knowledge and factors that generate propensity to~          dispense antibiotics without prescription will allow the design of specific educative~          interventions to antibiotic use~        5. The interventions designed from gaps detected in knowledge and attitudes with respect~          to antibiotics and resistance will improve the prescription and dispensation of~          antibiotics by physicians and pharmacists, respectively.~        6. The intervention will collaborate in the control of the bacterial resistance.~   "
67523|NCT02173496|"~     Neovascular or wet age-related macular degeneration (ARMD) is a retinal disease and is the~     leading cause of sight loss in the over 50s; it constitutes a major public health problem~     which will have an increasingly large impact as the population ages, because sight loss has~     been associated with loss of independence, depression, social isolation, and falls.~      Recent advances in medicine, and in particular the approval on behalf of the National~     Institute for Health and Clinical Excellence (NICE) for use of ranibizumab (Lucentis) in wet~     ARMD, have allowed this condition to be treated; however success is more likely when~     treatments occur at a very early stage.~      Unfortunately the early stages of wet ARMD do not cause symptoms and most cases are~     diagnosed when irreversible retinal damage has already occurred.~      In all stages of ARMD, even when no symptoms are present and non-invasive techniques~     currently used in routine clinical practice are not sufficiently sensitive to identify~     abnormalities, retinal function and possibly anatomy are abnormal.~      This study will evaluate techniques that may be useful in flagging subjects with the~     preclinical stages of the disease. This may allow early preventative measures to be taken,~     in order to stop altogether the onset of blindness.~      The study will focus mainly on colour contrast sensitivity, a simple but highly sensitive~     technique to assess retinal function, to establish if people with wet ARMD can be identified~     before symptoms develop. Other assessment modalities, evaluating either structure or~     function of the retina, will also be employed in selected individuals to establish if they~     may be used in the routine clinic; however it is already known that these modalities are not~     suitable for all individuals, as they are more demanding time-wise and concentration-wise,~     and therefore not universally suitable.~   "
67524|NCT02173483|"~     The purpose of this study is to determine whether there is a difference in muscle strength~     after anterior cruciate ligament comparing 2 surgery technics. Using either autograft~     hamstrings tendon or a autograft quadriceps tendon.~   "
67525|NCT02173470|"~     To assess if information about aortic calcification obtained from routine preoperative ultra~     low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery~     by optimizing surgical strategy compared to the normal work-up with a conventional chest~     X-ray.~   "
67526|NCT02173457|"~     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare~     with Sitagliptin.~   "
67527|NCT02173444|"~     Serum bio-markers have different prediction values for ovarian response during ovarian~     stimulation in-vitro fertilization~   "
67528|NCT02173431|"~     Prolonged external pressure to the tissue leads to compression, ischemia and development of~     pressure ulcer.~      Underweight seems to be associated with high pressure ulcer risk but the distinct relation~     between overweight and pressure ulcer development is uncertain.~      Bedsores are caused by pressure against the skin that limits blood flow to the skin and~     nearby tissue.~      Others factors related to limited mobility can make the skin vulnerable to damage and~     contribute to the development of pressure sores. Three primary contributing factors are~     sustained pressure, friction and shear.~      Bedsores are easier to prevent than to treat.~   "
67529|NCT02173418|"~     The purpose of this study was to test whether peroperative infiltration of the phrenic nerve~     during lung surgery would protect patients against postoperative shoulder pain.~   "
67530|NCT02173405|"~     This research study because is looking at woman with symptoms of chronic pelvic pain caused~     by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The~     purpose of this study is to determine whether or not injections with onabotulinumtoxinA~     (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA~     approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic~     pain (MPP). Therefore, Botox is considered experimental or research in this study.~   "
67531|NCT02173392|"~     A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL~     dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)~   "
67532|NCT02173379|"~     ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind,~     multi-center study, registering approximately 3000 subjects from approximately 140 sites in~     the United States and outside the United States. ABSORB IV is a continuation of ABSORB III~     (NCT01751906) trial which are maintained under one protocol because both trial designs are~     related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV~     primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.~      The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the~     safety and effectiveness as well as the potential short and long-term benefits of Abbott~     Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS~     System (once commercially available), as compared to the commercially approved, control~     stent XIENCE.~   "
67544|NCT02173223|"~     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5%~     and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering~     surgery and uncontrolled IOP who are facing further surgical intervention. Patients will be~     treated for 6 months in this initial trial.~      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the~     necessity of further surgical intervention.~   "
67616|NCT02172287|"~     To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium~     inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A~     secondary objective of this study was to compare the impact of tiotropium and salmeterol on~     humanistic and economic health outcomes, such as quality of life, patient preference and~     Health Resource Utilisation in this patient population.~   "
67533|NCT02173366|"~     African American women have among the highest rates of overweight and obesity and few meet~     dietary or physical activity guidelines. The investigators seek to develop a new~     intervention strategy that will help alleviate health disparities, thereby improving quality~     of life, health care costs, and disease burden. The African American Collaborative Obesity~     Research Network (AACORN) recommends an eco-social, community-engaged approach to behavior~     change that is in line with cultural values of interconnectedness and care for others. The~     purpose of this study is to operationalize the AACORN paradigm to promote improvements in~     weight status and health through a civic engagement approach. To achieve this, participants~     will meet in church-based Change Clubs and be led through a 6 month curriculum, which~     includes both lessons in cardiovascular risk reduction and a civic engagement project. Civic~     engagement may lead to change in individual health behaviors by increasing self-regulation~     and self-efficacy. The investigators will measure club members' adherence to the Change Club~     intervention, defined as average number of sessions attended, retention in the clubs,~     satisfaction with the Change Club experience and achievement of at least 50% of~     self-identified benchmarks for community change within 6 months. In addition the~     investigators will compare anthropometric factors, diet and physical activity behaviors,~     blood pressure, cardiorespiratory fitness, and psychosocial factors before and after~     participation in the Change Club intervention.~   "
67534|NCT02173353|"~     The purpose of this study is to evaluate the effectiveness of using ultrasound to image and~     track pancreas/duodenum motion during radiation therapy treatment delivery. Also develop a~     workflow and process to allow the final ultrasound system to be used routinely by radiation~     therapists.~   "
67535|NCT02173340|"~     Sedation during spinal anesthesia is very useful for patients' comfort. However,~     intermittent bolus of sedative frequently results in inappropriate sedation which comes with~     various side effects such as patients' discomfort and apnea. Therefore, it would be~     reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious~     side effects.~      In this study, the investigators try to find the appropriate propofol target concentration~     with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol~     target concentration and side effects.~   "
67536|NCT02173327|"~     Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery~     remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one~     approach to minimize the frequency and severeness of PPC.~      In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used~     routineously after major abdominal surgery.~      Recently new devices has been designed, which give the opportunity tip deliver continuously~     CPAP with out interruptions because of presumed better comfort. Therefore better patient~     compliance.~      No studies to date have investigated the possible benefit of using continuously helm CPAP~     versus the traditional intermittent mask CPAP after major abdominal surgery.~      The investigators' study will investigate if there are any benefits with continuously Helm~     CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.~   "
67537|NCT02173314|"~     The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes~     three populations. It will examine how the interventions SAFE- FC and FSE impact or relate~     to permanency outcomes for children most at risk for long term foster care and currently in~     care.~   "
67538|NCT02173301|"~     The purpose of the study are:~        1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of~          moderate-to-severe chronic plaque-type psoriasis.~        2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.~        3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of~          peripheral blood samples.~   "
67539|NCT02173288|"~     The development of ascites in the natural history of cirrhosis heralds a worsening of the~     prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the~     ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to~     neurohumoral systems are essential in pathophysiology of ascites formation. The theory that~     best explain the ascites formation and sodium retention in cirrhotics is portal hypertension~     leading to splanchnic arterial vasodilatation leading to underfilling of arterial~     circulation which is sensed by the arterial and the cardiopulmonary receptors leading to~     sympathetic nervous system activation and activation of the anti-natriuretic factors (RAAS~     and arginine vasopressin), resulting in sodium and water retention. The therapeutic options~     available for patients with refractory ascites are serial therapeutic paracentesis, liver~     transplantation and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor~     antagonists antagonize the antidiuretic effects of vasopressin at the V2 receptor located in~     the renal collecting duct, they increase free water clearance, and thus may be helpful in~     mobilizing excess water in conditions associated with water retention including cirrhosis.~     The use of V2 receptor antagonists in cirrhosis with ascites has been shown to be safe and~     efficacious. Midodrine, an alpha adreno receptor agonist by causing splanchnic~     vasoconstriction has been used in hepatorenal syndrome (HRS) and for control of ascites in~     patients with refractory or recurrent ascites. It is possible that vasoconstrictors and~     aquaretics (V2 receptor antagonists) by acting at different sites in combination may reverse~     some of the pathogenic events that results in refractory or recurrent ascites.There are no~     reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis~     with ascites. Therefore, we plan to study the role of midodrine, tolvaptan and their~     combination on systemic hemodynamics, renal functions and control of ascites in patients~     with cirrhosis and refractory or recurrent ascites.~   "
67540|NCT02173275|"~     The study seeks to determine the accuracy of using anatomic and physiologic information~     measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT~     and to compare this measure to stress testing for the detection of myocardial ischemia~     against the gold standard of cardiac catheterization with fractional flow reserve. The~     hypothesis of this proposal is that integrating anatomic plaque features with physiologic~     fractional flow reserve-CT will optimize identification of coronary lesions that are~     ischemia-causing by computed tomography .~   "
67541|NCT02173262|"~     The Integrated Consent Model is being increasingly used internationally to improve patient~     care. In this feasibility study we will explore whether the model is feasible in practice;~     and whether it can be used to increase the number of physicians and patients who take part~     in clinical trials, and address the critical issue around the optimal febrile neutropenia~     prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.~   "
67542|NCT02173249|"~     The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170~     0.24% in Healthy, Adult Subjects when used twice daily for one week.~   "
67543|NCT02173236|"~     The impact of platform switching with flapless surgery on early-loaded single-tooth implants~     on esthetic outcomes.~   "
67559|NCT02173028|"~     Patients will be treated according to the clinical practice of the participating centers and~     to the international guidelines for the treatment of heart failure.The present analysis~     provides a collection of data about the changes to drug therapy after the Cardiac~     Resynchronization Therapy (CRT) procedure , and any signs and symptoms of intolerance to~     prescribed medications.~   "
67545|NCT02173210|"~     This project is examining genetic and metabolic markers for the use of 17~     hydroxyprogesterone caproate (17OHPC) in pregnant women with a history of preterm birth~     (PTB). 17OHPC has been associated with a 30-35% reduction in repeat PTB in women carrying a~     singleton gestation. However, it is not well known why it works for some women but not for~     others. There are limited available interventions for the prevention of recurrent PTB. This~     study will enroll 150 women at risk for PTB and eligible to receive 17OHPC, and expect that~     80% will use 17OHPC and 20% will decline use. We will obtain blood samples and samples of~     cervical cells and cervical vaginal fluid. The objective of the study is to identify~     genetic, microbial and molecular markers that help to identify which women at risk for~     recurrent preterm birth will respond to 17OHPC and which women will not. The ultimate goal~     is to develop a personalized screening test based on these markers.~   "
67546|NCT02173197|"~     To date, there are no studies that demonstrate that the intervention of Occupational Therapy~     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical~     and functional outcome for the patient.~      For this reason, we intend to undertake a study that will allow us to deepen the knowledge~     about the impact of the OT on in-hospital patients considered complex according to the~     assessment by the Rehabilitation Complexity Scale (RCS ).~      Our hypothesis is that the intervention of OT can improve their care by qualified and~     focused on the needs of the person interventions.~   "
67547|NCT02173184|"~     To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot~     treatment period in patients with bacterial vaginosis, based on the Nugent Score and the~     Amsel criteria~   "
67548|NCT02173171|"~     A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who~     Previously Received Talimogene Laherparepvec~   "
67549|NCT02173158|"~     Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous~     Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.~   "
67550|NCT02173145|"~     Idiopathic pulmonary fibrosis (IPF) is a devastating disease with no cure available.~     Patients suffer from respiratory symptoms including dyspnea and cough. To improve life~     quality the investigators will test the effects of immunomodulation of macrolides~     specifically on cough in IPF patients. The investigators hypothesize that immunomodulatory~     treatment reduces cough frequency and might improve lung function.~   "
67551|NCT02173132|"~     This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress,~     Work Ability and Work Performance in subjects with Hepatic Encephalopathy.~   "
67552|NCT02173119|"~     Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for~     the treatment of HCC. Palliative means that it does not cure the disease prolongs your life~     and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with~     an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a~     material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected~     into an artery (blood vessel) directly supplying blood to a HCC tumor.~      Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to~     quantify the amount of lipiodol delivered to the HCC tumors.~      In this study, the investigators want to see if patient survival is related to the amount of~     lipiodol delivered to HCC tumors.~   "
67553|NCT02173106|"~     This prospective, randomized, controlled, multicenter clinical trial will evaluate~     Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of~     Idiopathic Membranous Nephropathy.~   "
67554|NCT02173093|"~     The investigators have found in the previous research that the investigators can coat (arm)~     T cells with a special molecule called GD2 bispecific antibody that will help T cells~     recognize neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody~     recognizes GD2, a protein found on almost all neuroblastoma and osteosarcoma cells. The~     investigators put the GD2 bispecific antibody on T cells and give large numbers of these T~     cells back to patients. The investigators think that these T cells may have a better chance~     of killing neuroblastoma tumor cells when they are armed with GD2 bispecific antibody. This~     trial studies the side effects and best dose of activated T cells armed with GD2 bispecific~     antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and~     other GD2-positive solid tumors.~   "
67555|NCT02173080|"~     This Pilot study will enable development & assessment of a Polycystic Liver Disease-specific~     patient reported outcomes questionnaire (PLD-Q). Polycystic liver disease (PLD) is~     characterized by the formation of numerous cysts in the liver, and can lead to severe~     symptomatic hepatomegaly. It is common in patients with autosomal dominant polycystic liver~     disease (ADPLD) and autosomal dominant polycystic kidney disease (ADPKD).~   "
67556|NCT02173067|"~     The purpose of this study is to investigate the variation in blood glucose levels,~     hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes~     mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and~     without epinephrine.~   "
67557|NCT02173054|"~     Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such~     as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another~     way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory~     property could reduce irritant effects, emergent from using topical treatment and also~     reduce severity of acne.~      Research teams chose an adapalene gel to act as topical treatment for curing acne. It has~     anti-inflammatory and comedolytic effects and has fewer side effects than other groups of~     topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching~     sensation may occur if they are continually used for a long period. Thus, for the purpose of~     studying the efficacy of moisturizer containing licochalcone A, L-carnitine and~     1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has~     anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has~     anti-bacterial effect).~   "
67558|NCT02173041|"~     Substance Use Disorder has been showing a rising trend all over the world including India.~     The project tested whether a Integrated community wide effort of Prevention and Awareness~     Groups (PAG) to manage substance use would have a greater effect on treatment attendance and~     drug abstinence than a de-addiction program alone.~   "
67560|NCT02173015|"~     The purpose of this study is to evaluate the effect that a new fall prevention training~     program has on the fall incidence of long-term care facility residents at high-risk of~     falling.~   "
67561|NCT02173002|"~     Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young~     people. The disease is characterized by a heterogenic phenotype and the disease course by~     flares and remissions. As in most chronic diseases the economic burden of IBD is important~     due to direct health care costs and disability. Health care reorganization for IBD patients~     in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal~     inflammation results in irreversible bowel damage and complications and none of the~     presently available drugs is effective for all patients and many drugs have possible severe~     side effects. To prevent complications of the disease and side effects IBD should be~     monitored carefully. In the Netherlands however there is a shortage of gastroenterologists~     where the incidence of IBD is rising. Secondly evidence exists that direct involvement of~     health care workers, patient empowerment and integrated care can improve the outcome of~     chronic diseases. Thirdly many clinically relevant aspects (e.g. malnutrition) of this~     complex disease are not systematically followed in routine care. Finally the government~     demands registration of efficacy endpoints for expensive drugs in the near future. Therefore~     the investigators developed a web-based Telemedicine tool for IBD patients in collaboration~     with the Dutch IBD patient's organization (CCUVN). myIBcoach contains E-learning modules,~     monitors disease activity, disability, quality of life, adherence, infections, smoking~     status, side effects, stress and malnutrition on fixed time points with validated~     questionnaires, allows the patient to communicate with health care workers and gives~     feedback to the back office and the patient. A feasibility study in 30 IBD patients in 3~     centres showed a high satisfaction and compliance of IBD-patients and health care workers~     with this telemedicine tool.~      The aim of this study is to compare standard care for IBD patients in 3 hospitals with a~     care via the telemedicine tool myIBDcoach.~   "
67562|NCT02172989|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to~          ensure better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
67563|NCT02172976|"~     In this multicenter study, patients with resectable pancreatic carcinoma will be treated~     with (a) surgery followed by 6 cycles gemcitabine or (b) 6 cycles FOLFIRINOX followed by~     surgery followed by 6 cycles FOLFIRINOX.~      The overall survival between both therapies will be compared as well as other parameters.~   "
67564|NCT02172963|"~     The purpose of this study is to evaluate the safety and efficacy using placenta derived~     decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell~     transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse~     and that they have a positive clinical effect.~   "
67565|NCT02172950|"~     This multicenter, open-label, phase 3 extension study will investigate the safety and~     efficacy of rVIII‑SingleChain for prophylaxis and on‑demand treatment of bleeding episodes~     in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and~     previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to~     rVIII-SingleChain in this study, as well as in at least 50 previously untreated patients~     (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to~     rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate~     the use of rVIII-SingleChain in surgery.~   "
67566|NCT02172937|"~     The purpose of this study is to evaluate safety and efficacy using decidual stromal cell~     therapy for graft versus host disease after allogeneic hematopoietic stem cell~     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that~     they have a positive clinical effect.~   "
67567|NCT02172924|"~     The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell~     therapy for graft versus host disease after allogeneic hematopoietic stem cell~     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that~     they have a positive clinical effect.~   "
67568|NCT02172911|"~     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of~     INO-3112 DNA vaccines delivered by Electroporation to female subjects with HPV-16 and/or~     18-positive cervical carcinoma.~   "
67569|NCT02172898|"~     To conduct a prospective, multicenter, observational study of patients with~     well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age,~     gender, and race) with comparable history of alcohol consumption but no clinical evidence of~     liver disease (controls). At the end of the study, a robust clinical information, central~     bio-repository will be developed from both cases and controls.~   "
67570|NCT02172885|"~     The purpose of this study is to determine the safety and effectiveness of five infusions of~     characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis~     Imperfecta (OI).~   "
67571|NCT02172872|"~     Older patients with acute myeloid leukemia (AML) have a small (< 10%) chance of long-term~     survival. Despite the treatment of elderly AML patients with intensive chemotherapy, the~     survival has not been improved during the last decades.~      The purpose of this study is to determine whether frontline therapy with a 10-day decitabine~     schedule provides a better survival than standard intensive combination chemotherapy in~     elderly AML patients (>= 60 years).~   "
67572|NCT02172859|"~     The purpose of this study is to determine whether a chronic dose of a tryptophan-rich~     protein drink (lumiVida™) can improve cognitive function, emotional processing and sleep in~     middle-aged women. In addition, also genetic predictors of susceptibility to an increase of~     Trp levels will be investigated.~      lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators~     do not claim that this supplement is meant to treat any ailment~   "
67573|NCT02172846|"~     This phase I trial studies the side effects and best dose of hypofractionated proton beam~     radiation therapy when given together with paclitaxel and carboplatin in treating patients~     with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of~     radiation therapy that uses streams of protons (tiny particles with a positive charge) to~     kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days~     (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton~     beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung~     cancer~   "
67591|NCT02172612|"~     This will be an eight-week, prospective, placebo-controlled, randomized trial to evaluate a~     patient-centered team (pharmacist-physician) intervention to improve medication~     appropriateness and reduce the use of inappropriate anticholinergic medications in elderly~     patients enrolled in the Sanders-Brown Alzheimer's Disease Center (ADC) cohort.~   "
67574|NCT02172833|"~     Over the past few decades, a good number of studies with regard to coagulopathy and~     increased bleeding tendency which is defined as macro- or microscopic hemorrhage,~     declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially~     caused by the use of antibiotics through a variety of suggested mechanisms, including~     myelosuppression, immune-mediated destruction of thrombocytes and coagulation factors, and~     suppression of vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase~     which may lead to inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have~     been reported or published. Nevertheless, many of them are case-series studies or case~     reports with low level of evidence, and there have been no large-scale retrospective cohort~     studies regarding antibiotic-associated coagulopathy being published. Moreover, in addition~     to exposure to antibiotics, there are several risk factors, including severity of illness,~     hepatic or renal function, nutrition status, comorbidities such as cancer and hematologic~     disease, surgery or other invasive procedure, concomitant use of anticoagulants, NSAIDs, and~     salicylates, and age, which may exert influence on the function of the coagulation system as~     well. Therefore, the study aims to clarify the association between the use of antibiotics~     and the increase of bleeding tendency or the development of bleeding event and to identify~     possible risk factors of the increase of bleeding tendency or the development of bleeding~     event in patients receiving antibiotic treatment through the application of nested~     case-control design and the usage of both the National Health Insurance Research Database~     (NHIRD) and medical records in National Taiwan University Hospital during the time period~     from January, 1995 to December, 2013.~   "
67575|NCT02172820|"~     Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality~     for patients hospitalized with myocardial infarction, coronary bypass surgery or~     percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is~     indicated choose to participate. Medicaid coverage and similar state-supported insurance are~     robust predictors of CR non-participation. There is growing recognition of the need to~     increase CR among patients with this form of insurance and other economically disadvantaged~     patients, but there are no evidence-based interventions available for doing so. In the~     present study we are examining the efficacy of using financial incentives for increasing CR~     participation among Medicaid patients. Financial incentives have been highly effective in~     altering other health behaviors among disadvantaged populations (e.g., smoking during~     pregnancy, weight loss). For this study are randomizing 130 CR-eligible Medicaid enrollees~     to a treatment condition where they receive financial incentives contingent on initiation of~     and continued attendance at CR sessions or to a usual-care condition where they will not~     receive these incentives. Treatment conditions will be compared on attendance at CR and~     end-of-intervention improvements in fitness, decision making and health-related quality of~     life. Cost effectiveness of the treatment conditions will also be examined by comparing the~     costs of the incentive intervention and usual care conditions with their effects on~     increasing CR initiation and adherence. Should this intervention be efficacious and~     cost-effective, it has the potential to substantially increase CR participation and~     significantly improve health outcomes among low-income cardiac patients.~   "
67576|NCT02172807|"~     Study to investigate the efficacy and safety of Ba679BR powder inhalation during the~     continuous once/day administration to the patients with COPD using oxitropium bromide~     (Tersigan® aerosol) as the comparator drug.~   "
67577|NCT02172794|"~     The primary objective of this study is to evaluate the effect of tiotropium on gross~     muscular efficiency~   "
67578|NCT02172781|"~     Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo~     After 19 Days of Tiotropium Treatment~   "
67579|NCT02172768|"~     The primary objective of this trial is as follows:~      To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for~     developing an invasive fungal disease (patients who are being treated for acute or chronic~     graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell~     Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid~     Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of~     micafungin given daily.~      The secondary objective of this trial is as follows:~      To determine whether adequate exposure of micafungin is attained. To determine the safety of~     micafungin in this patient population~   "
67580|NCT02172755|"~     The purpose of this study is to determine the effects of age on the pharmacokinetic profile~     of BIA 2-093 and its active metabolites.~   "
67581|NCT02172742|"~     The purpose of this study is to investigate the effects of multiple-dose administration of~     BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.~   "
67582|NCT02172729|"~     To investigate whether increased dose of local anesthetic (lidocaine) increases duration of~     peripheral nerve block (adductor canal block) and to develop a model for assessing duration~     of peripheral nerve blockades. The investigators hypothesize that increasing the dose of~     lidocaine (by increased concentration) will increase the duration of an adductor canal~     block.~      The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 )~     made earlier with different concentrations of lidocaine and a placebo group. For further~     information see trial registration at European Union Drug Regulatory Authorities Clinical~     Trial System.~   "
67583|NCT02172716|"~     The primary objective of this study is to assess the short-term immune response of type-2~     diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.~      The investigators hypothesize that type-2 diabetes exacerbates the disruption of DC~     (dendritic cells)-mediated immune homeostasis associated with periodontitis.~   "
67592|NCT02172599|"~     The purpose of this study is to examine the contribution of sit-stand workstations to total~     daily physical activity in a multi-component office-based 12 month intervention.~   "
67593|NCT02172586|"~     Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan~     50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic~     blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of~     the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).~      Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of~     treatment and at the end of the study, evaluated by sphygmomanometric blood pressure~     measurement and ABPM~      Safety:~      Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters~   "
67584|NCT02172703|"~     Introduction: Increased intracranial pressure (ICP) is considered to be the most important~     intracranial mechanism causing secondary injury in patients admitted after acute traumatic~     brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage~     (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two~     ICP measurement methods available - intraventricular and intraparenchymal - require both a~     neurosurgical procedure in order to implant the catheter and probes within the brain. The~     invasiveness of current methods for ICP measurement limits the diagnoses reliability of many~     neurological conditions in which intracranial hypertension is a treatable adverse event. A~     reliable, accurate and precise non-invasive method to measure ICP would be of considerable~     clinical value, enabling ICP measurement without the need of a surgical intervention.~      Aim:~      The aim of this study is to validate a novel non-invasive ICP measurement device by~     comparing its measurement with the gold standard invasive ICP-measurement by intracranial~     probe. The device used in this study has been been developed in the Telematic Science~     Laboratory at the Kaunas University of Technology, Lithuania.~      Methods:~      The non-invasive ICP measurement method will be assessed prospectively using repeatable~     simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements~     on patients presenting with TBI and SAH. The device method is based on two-depth~     transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the~     intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial~     segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed~     by the pressure Pe externally applied by the device. Two-depth TCD device is used as an~     accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood~     flow velocity waveforms in the intracranial and extracranial segments of OA are identical.~     The device has the same ultrasound transmission parameters as existing TCD devices and meets~     all patient safety criteria.~   "
67585|NCT02172690|"~     RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric~     cancer, yet the efficiency have not been fully investigated in Chinese people.~      PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as~     locally advanced gastric cancer.~   "
67586|NCT02172677|"~     Schemas describe mental structures storing recurrent and organized pattern of information.~     Schemas may have a strong influence on the process of storing and retrieving new information~     into memory. Previous approaches in the cognitive neuroscience of memory have entirely~     focused on the individual dimension of preexisting schemas. In the real world though, much~     of our experiences and knowledge are collective or shared. Such social-cultural frameworks~     stored in collective memory may also reshape and reconfigure the construction of individual~     memories. Attempting to ascertain the influence of collective schema on the neural~     substrates of individual memories using cutting-edge brain imaging methods represents the~     challenge that MULTIBRAIN seeks to tackle. To achieve this goal, we will record brain~     activity in a group of 24 participants while there are remembering pictures from a tour at~     the World War II Memorial of Caen. This study will seek to identify brain areas of the~     prefrontal cortex encoding the organization of knowledge in collective memory using~     multivariate analyses of brain patterns of activation, and then to understand how such~     regions might modulate the recruitment of the hippocampus during episodic memory retrieval~     using analyses of effective connectivity. The organization of knowledge in collective memory~     is measured in parallel through 1) the analysis of French social memory of World War II~     using a corpus of 100 000 television and radio shows from the National Institute of~     Audiovisual, and 2) an internet task measuring the organization of individual knowledge in a~     large group of individuals that will allow to separate shared from non-shared memories of~     the World War II. Once collected, these data will help us to understand how collective~     schemas may reconfigure the organization of individual memories.~   "
67587|NCT02172664|"~     The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA~     approved and marketed universal dental adhesive formulation in adult noncarious cervical~     lesions using self-etch and selective etch approaches.~      The hypothesis is that using a selective enamel etch with this universal adhesive will~     enhance the restoration margin performance.~   "
67588|NCT02172651|"~     This study seeks to learn more about the vitamin D receptor and its relationship to colon~     cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the~     receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause~     cancer cell death. Vitamin D has been used in other research studies and information from~     those other research studies suggests that Vitamin D may help in the treatment of colon~     cancer.~      Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study~     drug will be given 14-28 days prior to your surgery. The number of days will depend on when~     the surgery is scheduled.~   "
67589|NCT02172638|"~     The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new~     approach to the management of patients undergoing major surgery that re-examine traditional~     practices, replacing them if necessary with the best evidence based practices, creating a~     multimodal perioperative care pathway designed to achieve early recovery. In Colorectal~     Cancer Surgery , as well as in a number of other procedures it has been shown to reduce~     Hospitalization by more than 30% without increasing the rate complications or readmissions.~      However information on the results of Fast-track protocols when applied to Gynecological~     patients is sparse, being especially notorious the lack of data regarding the efficacy of~     Fast-track in the management of Advanced Gynecological cancer.~      Hypothesis: the application of a Fast-Track protocol in the management of patients with~     advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery~     of these patients allowing for an early discharge and significant cost reduction, when~     compared with de usual management, without increasing the number readmission or surgery~     related complications.~   "
67590|NCT02172625|"~     Nutrition supplementation with antioxidants have been discussed as a way to further enhance~     overall well-being of athletes, promote faster recovery, and improve overall performance.~     The use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150~     mg; milk thistle 225mg; ashwagandha 150 mg; green tea 75 mg; turmeric 75 mg) has shown~     promise in an earlier study by reducing oxidative stress and increasing the amount of the~     anti-oxidant enzymes in the blood.~      The purpose of this study was to examine the effect of ~90 day Protandim supplementation on~     5-km running performance and on acute and long term oxidative damage as assessed by blood~     markers. Secondarily, another purpose of this study examined the effect of Protandim~     supplementation on other blood parameters (such as antioxidant enzyme concentrations) and~     measures of quality of life. The experiment was double-blind, placebo controlled. The study~     addressed two main questions and two secondary questions:~      Main Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) improve~     5-km running times? Hypothesis: Protandim would improve 5-km running time by 0.5 min (SD~     1-min). This is equivalent to an effect size of 0.5. The placebo group will have no change~     in performance.~      Main Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) reduce~     oxidative damage at rest as assessed by lipid peroxides (TBARS) in runners? Hypothesis:~     Based on the data by Nelson et al. (2006), oxidative damaged would be reduced by 40% (effect~     size = 4.8).~      Secondary Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) in~     runners reduce the increase in oxidative damage post-race compared to pre-race as assessed~     by lipid peroxides (TBARS)? Hypothesis: Based on the data by Kyparos et al. (2009), we~     expected a 45% increase in TBARS post-exercise compared to pre-exercise (effect size of~     3.6). However, we expected that those that are on Protandim for 90 days will only have 31%~     increase in TBARS post-race (effect size = 2.5) [based on changes in pre-post lipid~     peroxides from Arent et al. (2010)].~      Secondary Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days)~     improve quality of life according to WHOQOL-BREF (Skevington, Lotfy, O'Connell, & Group,~     2004)? Hypothesis: There would be a statistical improvement in the quality of life~     post-Protandim supplementation which a small effect size improvement of 0.33.~   "
67595|NCT02172560|"~     The objectives were to collect information on vital status and pulmonary medication use at~     the predicted exit date for patients who participated in two one-year trials and withdrew~     prematurely. The primary objective was to ascertain the vital status (dead or alive) of~     these patients in the time interval between the patients' withdrawal from the trial and~     their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30~     days). The secondary objective was to collect information on classes of pulmonary medication~     and some other specified pulmonary interventions used by these prematurely discontinued~     patients at the time of their predicted exit date (i.e 48 weeks from the first intake of~     randomised treatment + 30 days) or at date of death (if this occurred during the time~     interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).~   "
67596|NCT02172547|"~     Post marketing Surveillance to gain insights into the effects of therapy with Spiriva®~     (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking~     during treatment and to obtain safety data regarding adverse events.~   "
67597|NCT02172534|"~     Study to obtain information about the safety and tolerability of tiotropium bromide~     administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and~     adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as~     well as to obtain pharmacokinetic data for tiotropium in CF patients after single and~     multiple doses~   "
67598|NCT02172521|"~     -  Primary objective of this observational study was to gain insights into the effects of~          therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality~          of life and physical functioning in patients with chronic obstructive pulmonary disease~          (COPD) and demonstrated hyperinflation.~        -  Secondary objective was to obtain safety data regarding adverse events.~   "
67599|NCT02172508|"~     The primary objective of the study is to investigate the effect of the combined therapy 18~     μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary~     rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients~     with moderate to severe COPD. The secondary objective of the study includes assessments of~     the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo~     plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and~     lung volumes. The third objective of the study is to investigate the correlation between the~     results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and~     daily activity.~   "
67600|NCT02172495|"~     Post-marketing surveillance to gather information regarding the tolerance and efficacy of~     Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.~   "
67601|NCT02172482|"~     As part of the post-marketing surveillance, information is to be gathered regarding the~     tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of~     daily practice~   "
67602|NCT02172469|"~     To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg~     once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD~   "
67603|NCT02172456|"~     Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled~     tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as~     well as in patients with mild, moderate and severe COPD~      Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety~     and tolerability~   "
67604|NCT02172443|"~     The objective of this study is to compare the bronchodilator efficacy and safety of~     tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg~     q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)~   "
67605|NCT02172430|"~     The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium)~     powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator.~     Secondarily, the long-term efficacy of Ba 679 BR is also investigated~   "
67606|NCT02172417|"~     Study to investigate the effect of an inhibition of the renal cationic drug transporter on~     single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to~     typical Chronic Obstructive Pulmonary Disease (COPD) population~   "
67607|NCT02172404|"~     Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the~     learning retention of the administration technique for the HandiHaler® vs. MDI and to~     compare the ease of use for HandiHaler® vs. MDI~   "
67608|NCT02172391|"~     Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter~     in COPD patients as measured by inspiratory capacity (IC).~   "
67609|NCT02172378|"~     Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function~     and static lung volumes, correlate this effect with dyspnoea in COPD patients.~   "
67610|NCT02172365|"~     The investigators will evaluate the outcomes of allogeneic stem cell transplantation which~     is the only curative treatment modality in the patients with chronic myeloid leukemia after~     failing tyrosine kinase inhibitor therapy. However, any update was not reported on the~     transplant outcomes in the patients failed TKI therapy, thus necessitating update of this~     data. Also, the European Group for Blood and Marrow Transplantation (EBMT) risk score is~     still of value, but insufficient numbers of patients have been transplanted in recent years~     and after TKI therapy to allow a robust reanalysis. Our study hypothesis is that allogeneic~     SCT treatment modality can rescue CML patients who failed TKI therapy due to resistance or~     to intolerance with improved survival and long-term outcomes. Also, another hypothesis will~     be examined if the EBMT risk score proposed pre-imatinib era can reproduce similar~     prognostic risk stratification of long-term outcomes in the patients treated with TKI.~   "
67611|NCT02172352|"~     To investigate the dose response following single inhalation of Ba 679 BR inhalation powder~     in COPD patients using pulmonary functions as indicators, and to compare data obtained with~     overseas study findings~   "
67612|NCT02172339|"~     Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in~     patients with renal impairment in comparison to healthy subjects.~   "
67613|NCT02172326|"~     Study to evaluate the pharmacokinetics of tiotropium following 14 days of administration~     (18µg once per day) in elderly COPD patients.~   "
67617|NCT02172274|"~     Study to determine the pharmacokinetics of BI 10773 and total radioactivity including~     excretion mass balance, excretion pathways and metabolism following the oral administration~     of [14C] BI 10773~   "
67618|NCT02172261|"~     The objective was to investigate whether there was a drug-drug interaction between BI 10773~     and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773~     and glimepiride were determined when both drugs were given in combination compared to~     multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given~     alone.~   "
67619|NCT02172248|"~     The objective was to investigate a possible drug-drug interaction between BI 10773 and~     metformin when co-administered as multiple oral doses. Therefore, the relative~     bioavailabilities of BI 10773 and metformin were determined when both drugs were given in~     combination compared with BI 10773 or metformin given alone.~   "
67620|NCT02172235|"~     The objective was to investigate the effect of different doses of BI 10773 on the~     bioavailability of pioglitazone after multiple oral doses of both drugs~   "
67621|NCT02172222|"~     Study to investigate the relative bioavailability of BI 10773 and of linagliptin after~     concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in~     comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.~   "
67622|NCT02172209|"~     Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a~     single dose BI 10773 tablet in healthy subjects~   "
67623|NCT02172196|"~     The objective was to investigate whether there was a drug-drug interaction between BI 10773~     and sitagliptin when co-administered as multiple oral doses. Therefore, the relative~     bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in~     combination compared with BI 10773 or sitagliptin given alone.~   "
67624|NCT02172183|"~     This is the first randomized controlled study that tests the efficacy of a~     cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in~     pharmacological treatment but still presented persistent symptoms.~   "
67625|NCT02172170|"~     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single~     rising oral doses of BI 10773 to healthy male subjects.~   "
67626|NCT02172157|"~     Primary objective:~      To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS -~     glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and~     metabolism following intravenous and oral administration of [14C]BI 1744 CL~      Secondary objective:~      To determine safety and tolerability following intravenous and oral administration of~     [14C]BI 1744 CL in healthy male subjects~   "
67627|NCT02172144|"~     Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG~     (electrocardiogram) in comparison to placebo~   "
67628|NCT02172131|"~     To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI~     1744 CL~   "
67629|NCT02172118|"~     Study to assess the influence of severe renal impairment on the pharmacokinetics (PK),~     safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by~     inhalation with the Respimat® Inhaler)~   "
67630|NCT02172105|"~     Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy~     Japanese male volunteers.~   "
67631|NCT02172092|"~     The purpose with the study is to follow the fluid shifts that occur during fluid~     resuscitation of patients with diabetic ketoacidosis.~      In the study measurements of changes in blood and urine concentrations of Sodium and~     Chloride as well as blood hemoglobin are used to mathematically calculate changes in~     distribution volumes of these different endogenous markers.~   "
67632|NCT02172079|"~     Controversy exists regarding the effectiveness of manual therapy techniques for the~     management of impingement syndrome. However, no adequately powered clinical trials have~     examined the effects of mobilization-with-movement. The purpose of the current study was to~     perform a randomized controlled trial comparing the effects of real MWM to a group receiving~     a sham intervention on shoulder pain at different moments and active shoulder range of~     motion in an adequately powered sample of patients with shoulder impingement syndrome.~   "
67633|NCT02172066|"~     In the aftermath of natural disasters, e.g., flood disasters, there is a great need for~     humanitarian assistance in the domain of psychological support. This is particularly true in~     post-conflict settings because people have suffered severely from multiple traumatic events~     and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term,~     culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder~     (PTSD) symptoms.~      The investigators want to provide evidence, that NET is an effective and efficient module to~     assist people in the aftermath of natural disasters using the example of the recent flood~     disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences~     and maltreatment during childhood may influence treatment outcomes.~   "
67634|NCT02172053|"~     Studies show that exercise resistance in workplace can reduce the symptoms of induced labor,~     however, the effectiveness of such programs depends on the characteristics of the training~     fatigue. Thus, it is expected that this study the intervention group with training heavy~     using progressive resistance exercise protocol will be better in reducing fatigue when~     compare with light training group.~   "
67635|NCT02172040|"~     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety~     of amlodipine besylate in subjects with hypertension requiring antihypertensive therapy.~      This study is being conducted to support a future marketing application for KIT-302, an oral~     fixed combination drug product (FCDP) consisting of the antihypertensive drug amlodipine~     besylate and the non-steroidal anti-inflammatory drug (NSAID) celecoxib.~      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve~     patient compliance with the once a day administration of its individual components,~     amlodipine and celecoxib, when used together for the treatment of hypertension in patients~     who also require the use of an NSAID for relief of the signs and symptoms of osteoarthritis.~      Although the final KIT-302 formulation will be a single capsule, for this study, two~     separate capsules will be utilized: one containing a commercial celecoxib capsule~     (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate~     tablet (Norvasc®) or matched placebo tablet.~      The study hypothesis is that treatment with the amlodipine besylate containing capsule plus~     the celecoxib containing capsule will reduce blood pressure (BP) in subjects with~     hypertension with an efficacy that is not substantially inferior to the effect of amlodipine~     besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the~     celecoxib capsule).~   "
67636|NCT02172027|"~     Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that~     is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion~     of lung cancer patients is a cytological test and serves as an initial diagnosis. These~     cells can then be used to prepare a cell block for staining and further tests.~      In some research despite clinical suspicions, the cytological diagnosis is negative, due to~     the specimen containing too few cells or damage to the cells whilst the specimen is~     processed. A new method of identifying rare cells in a fluid is by immunomagnetic~     separation. Using this method, an antigen binds to proteins in the cell wall that are unique~     to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the~     cells with the magnetic tags from the remainder of the cells. The separated cells can then~     be stained or cultured.~      The currently approved method of immunomagnetic detection has been approved for clinical use~     in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli~     Biotech company has developed an advanced technology that allows identification of a larger~     number of cells without causing morphological damage to the cells.~      The purpose of the current study is to examine the technique of immunomagnetic separation in~     pleural effusion of lung cancer patients in comparison to the cytological tests. In the~     future it is hoped that a larger number of patient samples will be included and further~     characterization of the cells will be possible to be compared to the clinical and~     cytological characteristics.~   "
67637|NCT02172014|"~     Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically~     ill children with mechanical ventilation~      Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with~     midazolam in children with mechanical ventilation.~      Design: Double-blind randomized controlled study~      Patients: Patients age 2 months through 18 years who are admitted in Seoul National~     University Hospital pediatric intensive care unit, and applied with mechanical ventilation.~      Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal~     saline) is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents~     of the patient don't know whether the blind reagent is fentanyl citrate or not, but only~     preparing pharmacist knows that.~      Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent.~     The start time of study is when the continuous infusion of midazolam and blind reagent are~     begun. Assigned research nurse check Comfort behavior scale of the patient every hour~     regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours~     after begining. If there is any adverse effect or unexpected event, however, the study can~     be early terminated.~   "
67638|NCT02172001|"~     The primary objective of the study is to evaluate and compare the effect of iron~     isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with~     IDA when oral iron preparations are ineffective or cannot be used.~   "
67639|NCT02171988|"~     The purpose of the study is to investigate effect of medical treatment and prognosis of~     Postural Orthostatic Tachycardia Syndrome (POTS)~   "
67640|NCT02171975|"~     Multiple passes and attempts while administering spinal anesthesia are associated with a~     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The~     investigators hypothesised that the routine use of pre-procedural ultrasound-guided~     paramedian spinals reduces the number of passes required to achieve enter the subarachnoid~     space when compared to the conventional landmark-guided midline approach.~   "
67641|NCT02171962|"~     The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent~     for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient~     population.~   "
67642|NCT02171949|"~     The purpose of this study is to evaluate the safety and efficacy of multiple infusions of~     mononuclear bone marrow cells in patients with chronic liver diseases.~   "
67643|NCT02171936|"~     In the care of the chronic pain in pain's department, pain consultation or Evaluation and~     Treatment of the Pain Center (CETD), the patients are often in a situation of physical and~     psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the~     chronic painful patients lost their employment, are disintegrated because of their pain,~     this being able to provocate a loss of their financial autonomy. A large number of painful~     patients thus find themselves in situations of social vulnerability even of precariousness~     often denied and difficult to detect by the caring team. Precarity is define as  the lack~     of one or several securities, in particular the employment, allowing the people and the~     families to assume their professional, family or social obligations, and to enjoy their~     fundamental rights. To allow a earlier identification of the populations in deprivation~     situation, the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of~     health for the Centers of Examination of Health (CES)) was administered to more than 7000~     people. The individual score, indicator of the precariousness and the disparities of health,~     is calculated after answer to 11 questions and was calculated on about 200 000 French~     people. Among numerous indicators, it appears that the consumption of psychotropics or a~     negative perception of the health are socioeconomic indicators, mode of life and health~     which are prevailing according to the quintiles of the score EPICES.~      This national study, on the French CETD aims is: 1 - to study prevalence of the social~     vulnerability even of the precariousness thanks to adapted questionnaires of which the~     questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and~     amplify this circumstance, 3 - to identify the patients for whom a situation of~     precariousness and social vulnerability is proved true, justifying the earlier orientation~     towards the social worker of the Center so allowing a global care of the patient during~     the second visit~   "
67644|NCT02171923|"~     To examine whether the medial prefrontal cortex displays an increased activity during~     self-referential processing among remitted depressed patients compared to healthy controls~   "
67645|NCT02171910|"~     Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography~     (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with~     use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally~     benzodiazepines have been used but nowadays propofol is becoming the drug of choice for~     sedation during ERCP.~      The problem with propofol sedation is the fact that it may case cardiorespiratory depression~     and there is no antidote for this like there is for benzodiazepines. Cardiovascular~     depression can usually be easily counteracted with drugs that are used to raise blood~     pressure or heart rate during general anesthesia but respiratory depression remains a~     problem.~      The aim of this study is to try to counteract the respiratory depression caused by propofol~     sedation using an old respiratory stimulant doxapram as opposed to placebo using a double~     blind randomized protocol.~      The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the~     respiratory depression caused by propofol sedation.~   "
67664|NCT02171663|"~     The primary objective was the assessment of safety of BIBW 2992 as assessed by the maximum~     tolerated dose (MTD). Secondary objectives were collection of overall safety data, antitumor~     efficacy data, as well as the determination of pharmacokinetics and the pharmacodynamic~     modulation of biomarkers by BIBW 2992.~   "
67646|NCT02171897|"~     This is a single-centre, comparative, prospective randomised trial. It will include 70~     patients over a period of 2 years randomized into two groups of 35 patients: one group of~     patients treated with osteosynthesis (plate, nail or screw) and the second group treated~     with total hip replacement.~      The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1~     year.~      The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality~     of life questionnaire, the VAS score for pain at rest and when walking, the Parker score,~     the rate of complications and deaths will also be measured. Operating time, blood loss and~     scar size will also be evaluated.~   "
67647|NCT02171884|"~     For this project, 4 groups of 38 infants have been created so as to evaluate the impact of~     Assisted-Reproduction Technology (ART) and more particularly the two procedures classically~     used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of~     culture in appropriate in vitro conditions to allow development of the embryo) in contrast~     with shorter culture of only two days.~      Participation consists in accepting samples to be taken at the birth of the infant:~        1. from the umbilical cord.~        2. from the placenta.~   "
67648|NCT02171871|"~     The study will examine changes in the respiratory system mechanics and in respiratory~     physiology after exposure of subjects to passive smoking. It is about healthy non-smoking~     volunteers and it will be carried out through the techniques of forced oscillation with~     Impulse Oscillometry (IOS) technique methodology and nitrogen washout.~      The present study will contribute to the understanding of passive smoking consequences on~     the respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique,~     changes to closing volume and closing capacity will be examined during measurement in~     different positions (sitting, decubitus) together with exposure to passive smoking. With IOS~     methodology, changes in respiratory system resistance in four positions (standing, sitting,~     right and left lateral decubitus) will be evaluated before and after exposure to a passive~     smoking environment. Results of the present study are expected to provide interesting~     information on the changes in measured parameters not only in different positions but also~     after exposure to smoking.~   "
67649|NCT02171858|"~     Stroke is one of main causes of death and impairment worldwide. Objective of this study is~     to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients~     attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate~     with stroke extension and clinical features.~   "
67650|NCT02171845|"~     This is a single-centre study over 36 months for the inclusion of 30 patients. The selection~     and inclusion of patients will take place according to the criterion of Medical Termination~     of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23~     WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue~     will also be systematically harvested in parallel (liver and psoas muscle) for control~     purposes. The gonads will be subjected to molecular biology analyses destined to quantify~     the expression of transposons and their inhibitors.~   "
67651|NCT02171832|"~     The main objective of this study was to investigate the influence of mild and moderate liver~     impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI~     1744 CL in comparison to a control group with normal hepatic function after single orally~     inhaled administration of BI 1744 CL with the Respimat® Inhaler.~   "
67652|NCT02171819|"~     This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole~     cell vaccine manufactured by the IVAC in Vietnam when given in two injections in two doses~     (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam.~   "
67653|NCT02171806|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL~   "
67654|NCT02171793|"~     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral~     doses of BI 1744 CL.~   "
67655|NCT02171780|"~     To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL~   "
67656|NCT02171767|"~     Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4~     different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg,~     50 mg) administered as single doses to healthy male volunteers~   "
67657|NCT02171754|"~     The objective was to investigate the effect of ritonavir, an inhibitor of P-glycoprotein~     (P-gp) and cytochrome P450 3A4 (CYP3A4), on the pharmacokinetics of BIBW 2992~   "
67658|NCT02171741|"~     Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW~     2992 when administered in combination with docetaxel as determined by drug-related adverse~     events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.~   "
67659|NCT02171728|"~     Investigation of maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamic~     parameters, and efficacy of BIBW 2992~   "
67660|NCT02171715|"~     The primary objective of the study was to investigate the relative bioavailability and~     pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet~     (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in~     comparison with the drinking solution and in comparison with the trial formulation II~     tablet, which was administered in phase II clinical trials and also partly in phase I~     trials.~   "
67661|NCT02171702|"~     The primary objective of the study was to identify the maximum tolerated dose and to~     evaluate safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992.~   "
67662|NCT02171689|"~     The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2~     after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers.~     Metabolites in human plasma and excretions were measured, the structures of the metabolites~     analysed and compared with metabolites in animals. In addition, the mass-balance of~     excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW~     2992 MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were~     measured. The safety and tolerability of BIBW 2992 were also investigated.~   "
67663|NCT02171676|"~     Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and~     efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)~   "
67665|NCT02171650|"~     The primary objective was to collect safety data for BIBW 2992.~   "
67669|NCT02171598|"~     The primary objective of the study (Main Part 2) was to investigate whether and to which~     extent a combination of multiple oral doses (steady state conditions) of 75 mg of~     clopidogrel q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran~     etexilate b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of~     dabigatran etexilate and clopidogrel.~      The objective of the preceding Pilot Part 1 of the study was to explore the effect of a~     single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg~     dabigatran had reached steady state, regarding safety as well as pharmacokinetic and~     pharmacodynamic parameters.~      The Main Part 3 of the study moreover was to compare intra-individually the effects of a~     single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally~     to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and~     pharmacokinetic and pharmacodynamic parameters.~   "
67670|NCT02171585|"~     To investigate whether and to what extent the reported potent P-gp inhibitor clarithromycin~     affects pharmacokinetic parameters (area under the curve (AUC) and maximal concentration~     (Cmax)) of dabigatran.~   "
67671|NCT02171572|"~     The objective of the current study is to investigate safety, tolerability and,~     pharmacokinetics of dabigatran etexilate following oral administration of single and~     multiple oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.~   "
67672|NCT02171559|"~     To investigate the relative bioavailability and the pharmacodynamics of dabigatran after~     switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone~   "
67673|NCT02171546|"~     Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on~     the bioavailability of dabigatran etexilate,~      Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe~     substrate for P-gp~   "
67674|NCT02171533|"~     To investigate whether and to what extent the P-glycoprotein inhibitor (P-gp) verapamil~     affects the pharmacokinetic parameters of dabigatran with verapamil given at different~     dosages, in different formulations (immediate release (IR) and extended release (ER)), and~     in different intervals in relation to the dabigatran dose.~   "
67675|NCT02171520|"~     The objective was to demonstrate the bioequivalence of capsules made from 2 different drug~     product batches. The reference batch was representative of the current commercial drug~     product and of the pivotal Phase III batches. The test batch was the drug product batch~     intended for future commercial use.~   "
67676|NCT02171507|"~     To investigate the relative bioavailability of dabigatran with and without concomitant~     administration of diclofenac and the relative bioavailability of diclofenac with and without~     concomitant administration of dabigatran etexilate~   "
67677|NCT02171494|"~     To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of~     Coumadin / formulation tablet~   "
67678|NCT02171481|"~     To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and~     polymorph II~   "
67679|NCT02171468|"~     To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran~     etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days)~     in healthy male subjects between Japanese and Caucasians~   "
67680|NCT02171455|"~     To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters~     prior to administration of a high dose of dabigatran etexilate in a QT study~   "
67681|NCT02171442|"~     The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048~     MS and BIBR 953 ZW in man.~   "
67682|NCT02171429|"~     This phase III, double blind, placebo and active comparator controlled, multicenter study~     will investigate the efficacy and safety of etrolizumab in induction of remission in~     participants with moderately to severely active UC who are naïve to TNF inhibitors and~     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.~   "
67683|NCT02171416|"~     Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized~     by the development of wheal and flare type skin reactions due to the release of histamine~     and other proinflammatory mast cell mediators following exposure of the skin to cold.~     Typically, symptoms occur within minutes after cold contact, including exposure to cold air,~     liquids or objects and are limited to cold exposed skin areas.~      The investigators postulate that there is an overlap between acquired cold urticaria and~     cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to~     antihistamines will benefit from IL-1 targeting treatment strategies.~      This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept~     in patients with cold contact urticaria who could not be successfully treated with~     first-line medication such as antihistamines.~      This is a double-blind placebo-controlled parallel group phase II study of the efficacy and~     safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the~     Urticaria specialty clinics of ACC. The total duration of the study course for each patient~     is 14 weeks and is divided in:~        1. Screening period (2 weeks, days -14-0)~        2. Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)~        3. Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized~          (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and~          will receive the respective dose subcutaneously. Following the placebo-controlled~          double-blind phase patients will enter the open-label phase and receive rilonacept~          open-label treatment (160mg or 320mg depending on treatment response during part A).~   "
67684|NCT02171403|"~     Most people are born with the ability to digest lactose, a dissacharide consisting of~     β-D-glucose and β-D-galactose, because of the presence of lactase at the brush border of the~     small intestine. In about 75% of the world population the activity of this enzyme decreases~     after weaning (primary hypolactasia or lactase-nonpersistence), resulting in incomplete~     digestion of lactose and lactose malabsorption in adulthood (1). Secondary forms of lactose~     malabsorption may be due to inflammation or functional loss of the intestinal mucosa such as~     celiac disease, infectious enteritis or Crohn's disease. Very rarely, lactase deficiency is~     congenital due to an autosomal recessive genetic disorder, preventing lactase expression~     from birth (2). Whereas some people with lactose malabsorption are asymptomatic, most~     lactose-nonpersisters experience symptoms like abdominal pain, bloating, excess flatulence~     or diarrhea. Lactose intolerance refers to the syndrome of having one or more symptoms after~     consumption of lactose-containing food (3). At present, the origin of the symptoms of~     lactose-intolerance is not well understood.~      Several studies have indicated a poor correlation between lactose maldigestion and symptoms~     of lactose intolerance (4). In a study by Vonk et al. (2003), lactose intolerant subjects~     with severe symptoms (diarrhea) and intolerant subjects with only mild symptoms (without~     diarrhea) did not differ in degree of lactose digestion in the small intestine indicating a~     similar lactase activity and leading them to the hypothesis of a colon resistence factor~     (5). It was suggested that the colonic processing of maldigested lactose may play a role in~     the symptoms experienced by lactose intolerant patients. When lactose is malabsorbed and~     enters the colon, it is rapidly fermented by the resident microbiota into a variety of~     metabolites including lactate, formate, succinate and short chain fatty acids (SCFA,~     acetate, propionate, butyrate) as well as gases (H2, CO2 and CH4). When incubating fecal~     samples from lactose-tolerant and intolerant subjects with lactose, the samples from the~     lactose-intolerant subjects showed faster production rates of D- and L-lactate, acetate,~     propionate and butyrate, as compared to tolerant subjects (6). Although the colon is thought~     to possess a high capacity to absorb SCFA, it was hypothesized that a temporary accumulation~     of these metabolites due to rapid fermentation of maldigested lactose could be responsible~     for abdominal pain, excess flatulence and bloating (7;8). Possible mechanisms proposed to~     explain how SCFA might induce symptoms included an increase in the osmotic load that draws~     fluid to the colonic lumen, changes in colonic motility and an increased colonic sensitivity~     (9-11). However, the calculated amount of fluid drawn in the colon is unlikely to cause~     symptoms considering the high water absorbing capacity of the colon and the effect of SCFA~     on colonic motility and colonic sensitivity have only been observed in rats and not in~     humans.~      More recently, Campbell et al. introduced the bacterial metabolic toxin hypothesis, stating~     that also other bacterial metabolites, such as alcohols, aldehydes, acids and ketones,~     resulting from carbohydrate fermentation play a role in the pathogenesis of~     lactose-intolerance. These metabolites might inhibit bacterial growth and affect eukaryotic~     cells (12). In our own previous studies in which we related colonic fermentation patterns to~     parameters of cytotoxicity, we identified compounds like propionic acid, medium chain fatty~     acids, 1-octanol and heptanal as more prevalent in the most cytotoxic samples (13),~     supporting the hypothesis of Campbell et al. Therefore, it seems necessary to include not~     only SCFA, but also other metabolites, in the investigation of the pathogenesis of lactose~     intolerance.~      Differences in fermentation patterns might be associated with differences in the composition~     and/or activity of the intestinal microbiota. Evidence on the potential role of the colonic~     microbiota in lactose intolerance is very limited. Total bacterial numbers were not~     significantly different between 16 intolerant and 11 tolerant lactose maldigesters although~     a negative correlation between total bacteria and symptom score was found (14). Similarly,~     the composition of fecal microbiota was not different between 5 intolerant and 7 tolerant~     subjects (6).~   "
67685|NCT02171390|"~     The study searched for answers to two questions~        1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with~          congenital hypogonadotropic hypogonadism?~        2. What is the effect of testosterone replacement therapy on endothelial dysfunction,~          inflammation and insulin resistance?~   "
67750|NCT02170545|"~     Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge~     for patients and orthopedic surgeons. Proximal humerus fractures represent the third most~     common fracture after hip and distal radius fractures, and more than 20% of these fractures~     meet operative indications. Unfortunately, one of the major complications of these fractures~     is the development of avascular necrosis (AVN), or death of the bone as a result of the loss~     of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this~     study is to determine if computed tomography imaging can identify a quantifiable predictor~     of AVN following this type of humeral fracture.~   "
67686|NCT02171377|"~     Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.~      Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD)~     patients has been demonstrated to improve both dyspnea and physical status. The aim of our~     study is to demonstrate that ES added to respiratory rehabilitation program induces a~     greater improvement on exercise tolerance in such patients.~      Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either~     rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both~     groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks),~     health education, global muscular strengthening. In group 2, bilateral quadricipital~     electrical stimulation 30 min sessions is added 5 days / week.~      Subjects : COPD patients with FEV1 < 50% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea,~     in stable conditions, and 18 > BMI < 35 kg/m² .~      Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity,~     work rate, ventilatory threshold), physical activity with activity monitor, health related~     quality of life will be determined before and after training.~      Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total~     lung capacity; BMI = body mass index.~   "
67687|NCT02171364|"~     Radiofrequency catheter ablation is highly effective in the treatment of patients with~     persistent atrial fibrillation. In order to decrease the recurrence rate after catheter~     ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by~     simulating 3D atrial computer model. The investigators will test with five different set of~     ablation methods and find successful methods for a specific patient. Then, this result will~     be compared to empirical catheter ablation result by randomly controlled trial.~   "
67688|NCT02171351|"~     Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to~     increase insulin sensitivity and improve metabolic control. However, adherence to PA is~     often poor, due to a lack of motivation or due to disabling complications or comorbidities.~     Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve~     muscle strength and volume in several situations: after stroke, after limb trauma or during~     chest rehabilitation in deconditioned patients. The investigators have already shown in a~     first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in~     the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin~     sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a~     population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up~     to 50% in the most deconditioned subjects. Discrepancy between this result and the very low~     energy expenditure measured during sessions suggests that the metabolic effect was not~     solely mediated by muscle contractions. The investigators hypothesize the involvement of~     neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an~     important regulator of glucose metabolism with pancreatic action, a key role in energy~     metabolism and a complex relationship with insulin resistance. Muscle activity, whether~     static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy~     subjects but its effect in type 2 diabetic subjects is not known. The investigators~     hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity~     by NMES could be involved in the improvement of insulin sensitivity. To address this~     question, the investigators propose to assess sympathetic nerve activity with the gold~     standard method of microneurography before and after a single bi-quadricipital NMES session.~     The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular~     threshold) and the impact of voluntary isometric muscle contractions (VC) will also be~     evaluated. These procedures will also be applied in healthy control subjects.~   "
67689|NCT02171338|"~     The purpose of this study is to investigate weather or not the use of a~     procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of~     antibiotics in patients with lower respiratory tract infections.~   "
67690|NCT02171325|"~     The purpose of this study is to identify the appropriate dose of irinotecan by dose~     escalation(dose climbing) test. The study would provide rationale for regimen decision in a~     future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be~     selected as therapeutic drugs.~   "
67691|NCT02171312|"~     The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain~     injury) system is a novel portable, open access platform that enables immediate and rapid~     assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT~     function testing battery with currently used balance and inner ear assessment methods during~     initial concussion clinic referral. Two groups of participants will be enrolled; a~     concussion related dizziness cohort and control subjects. The investigators will enroll the~     concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with~     persistent dizziness and imbalance symptoms following possible concussion. Healthy control~     participants will be recruited from the local community. iDETECT's ability to identify post~     concussion balance/vestibular disturbances will be compared to an expert concussion~     assessment. Both cohorts will participate in the iDETECT assessment and the clinical~     assessment.~   "
67692|NCT02171299|"~     Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart~     from the obvious immediate action it has been supported that a possible down regulation of~     pain receptors may lead to longer effects. Our aim was to compare the use of local~     anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.~      Materials and methods: We will conduct a RCT involving 400 consecutive general surgery~     patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with~     ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as~     well as the type and quantity of the analgesia used during the study period.~      Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic~     have lower pain during the 1st postoperative week and require less pain killers .~   "
67693|NCT02171286|"~     The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a~     prospectively defined set of genes.~      The purpose of this pilot study is to assess the feasibility and effect on~     clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced~     lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being~     considered for clinical trials.~   "
67694|NCT02171273|"~     The overall objectives of the proposed study are to examine the consequences of chronic~     circadian disruption and chronic sleep restriction on metabolic function in healthy older~     adults.~   "
67751|NCT02170532|"~     Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two~     new medications that have been approved by the United States Food and Drug Administration~     (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma~     bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There~     are also newer devices to deliver these medications into the lungs: breath actuated~     nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered~     dose inhalers (MDIs or puffers). The purpose of this study is to deliver these new~     medications using several different devices and measuring lung function, heart rate, and~     sensations of breathlessness.~   "
67695|NCT02171260|"~     This is a Phase 1 study of eribulin mesylate in pediatric patients with recurrent or~     refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be~     administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims~     to determine the MTD and/or the RP2D of this regimen in Part A1 (patients greater than or~     equal to 12 months and less than 18 years). Part A2 will enroll infants (greater than 6~     months and less than 12 months) one dose level behind the dose level at which patients in~     Part A1 are enrolling, in order to maximize safety for infant subjects. Additionally, this~     study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when~     administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate~     will also be described.~   "
67696|NCT02171247|"~     Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in~     the body as an alternative to directly injecting contrast into the vessels and taking~     pictures. Different types of intravenous (into the vein, IV) contrast are available to fill~     the vessels and make them easier to see. The purpose of the study is to determine the best~     type of contrast for this scan.~   "
67697|NCT02171234|"~     The purpose of this study is to investigate the safety and tolerability of multiple dose~     regimens of BIA 2-093 in healthy young male volunteers~   "
67698|NCT02171221|"~     This is a first-in-human, open label, single arm, sequential dose escalation and expansion~     study of oral DFP-11207 in patients with advanced solid tumors.~   "
67699|NCT02171208|"~     The primary objective of this study is to establish the bioequivalence of the test product~     (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012~     supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.~      The secondary objectives of this study are to determine the safety and tolerability of the~     test product compared to the reference product, to estimate PK parameters of the test~     product and the reference product, and to estimate the intra-subject coefficient of~     variation (CV%) of the referenced product for both area under the plasma concentration curve~     (AUC) and peak plasma concentration (Cmax).~   "
67700|NCT02171195|"~     The purpose of this study is to determine the safety and tolerability of single rising oral~     doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg)~     in groups of 8 healthy male adult volunteers.~   "
67701|NCT02171182|"~     The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin~     patch in real-life clinical practice in the treatment of post-operative neuropathic pain.~   "
67702|NCT02171169|"~     The purpose of this retrospective data review is to evaluate the health economic drivers and~     complications of two surgical procedures: transsacral lumbar interbody fusion and~     transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental~     screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and~     comply with US regulations and requirements.~   "
67703|NCT02171156|"~     To provide early access and to evaluate the safety and tolerability of nintedanib in~     patients with idiopathic pulmonary fibrosis (IPF).~   "
67704|NCT02171143|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis~     (RA) on methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2409.~   "
67705|NCT02171130|"~     Up to two hundred (200) adult patients with T1D aged 18 to 75 years will be selected for~     inclusion in the study. The target is to obtain treatment response and user-experience data~     following use of AMG504-1 in treating episodes of hypoglycemia. The population will be~     enriched to include participants who suffer from impaired hypoglycemia awareness.~   "
67706|NCT02171117|"~     Patients enrolled from each center according to confirmed criteria specified in cooperative~     scheme are randomly assigned to standard induction and consolidation chemotherapy with~     microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year~     disease-free survival (DFS) and overall survival(OS) rate of the two groups.~   "
67707|NCT02171104|"~     This study aims to test the effectiveness and safety of a novel conditioning regimen in~     attaining donor blood stem cell engraftment in persons with certain inherited metabolic~     disorders, severe osteopetrosis and males with Rett syndrome who undergo blood stem cell~     transplantation.~   "
67708|NCT02171091|"~     The purpose of this research study is to determine how cell changes during endotracheal~     intubation and artificial lung ventilation affect lung inflammation.~      Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal~     (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic~     (lung) samples will be collected at the same time intervals when possible and if they are~     done as standard of care.~      Blood samples will be obtained simultaneous with the collection of the trachael (windpipe)~     specimens.~   "
67709|NCT02171078|"~     Nearly three million living women have survived breast cancer. Physicians rely on clinical~     practice guidelines to make decisions on follow-up care. Among other things, the goal is to~     monitor for recurrence or side effects of treatment among survivors. It is unclear whether~     these guidelines represent the best approach for any given patient as they do not account~     for differences in disease or patient preferences and may not consider recent advances in~     imaging and treatment options. We seek to develop a new approach to surveillance following~     breast cancer treatment which will be more patient-centered and effective than the existing~     one-size-fits-all approach and will consider individual risk factors.~   "
67710|NCT02171065|"~     The present study has two components, an overall prospective observational study using~     multimodality imaging (PROSPECT II) that will examine the natural history of patients with~     unstable atherosclerotic coronary artery disease with the specific goal to establish the~     utility of low risk intracoronary imaging modalities, Intravascular Ultrasound (IVUS) and~     Near InfraRed Spectroscopy(NIRS), to identify plaques prone to future rupture and clinical~     events. Due to the difficulty of interpreting the IVUS images, this study will be, however,~     using Plaque Burden (PB) ≥65% as the primary threshold defining vulnerable plaques. However,~     sensitivity analyses will be run for patients and lesions with PB≥70%. The randomized~     PROSPECT ABSORB sub-study will examine whether treatment of vulnerable plaques with the~     ABSORB Bioresobable Vascular Scaffold (BVS) plus Guideline Directed Medical Therapy (GDMT)~     safely increases the Minimal Lumean Diameter (MLA) at 25 month compared with GDMTalone.~   "
67719|NCT02170948|"~     Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours,~     with patients generally being allowed to go home on the same day. Despite this, post-surgery~     pain is often severe and a delay in the discharge of patients due to difficulty with pain~     control after the surgery is common.~      Performing nerve blocks in association with sedation is the preferred way to provide pain~     relief and offers important benefits for foot surgeries. With nerve blocks, the requirement~     for oral painkillers and their associated side effects is reduced. Increasing the duration~     of local anesthetic action is helpful as it increases the time of pain relief, allowing for~     a smoother transition to oral pain medications, earlier discharge, and faster recovery.~      Recently, Precedex has been considered for its usefulness in prolonging the pain relief~     produced by nerve blocks. The identified benefits of this particular use include reducing~     post-surgical pain medications requirements, reducing the incidence of nausea and vomiting,~     reducing the incidence of sedation from such medication, and diminishing the incidence of~     respiratory depression (inadequate breathing). Two small studies have also shown that adding~     dexmedetomidine to nerve block solution results in prolonging pain relief.~      The purpose of the study is to examine several doses of dexmedetomidine combined with local~     anesthetic drugs and determine the best combination for prolonging pain relief, while~     minimizing potential side effects.~   "
67720|NCT02170935|"~     To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered~     1-3 hours post surgery in hip replacement patients.~   "
67721|NCT02170922|"~     Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food~   "
67722|NCT02170909|"~     Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048~     MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg~     and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and~     Caucasian origin.~   "
67723|NCT02170896|"~     To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each~     administered as four experimental capsule formulations relative to drinking solution with~     and without coadministration of 40 mg pantoprazole.~   "
67724|NCT02170883|"~     Between 8% and 12% of Canadians suffer from asthma. Although there are effective and~     inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic~     diseases.The purpose of this study is to determine whether enhancing the role of community~     pharmacists in asthma management using interactive short messaging service (SMS) with asthma~     patients is a cost-effective model that will improve adherence to inhaled corticosteroid~     medications compared to usual care.~   "
67725|NCT02170870|"~     To understand why patients with indigestion with or without diabetes have gastrointestinal~     symptoms and in particular to understand where the symptoms are related to increased~     sensitivity to nutrients.~   "
67726|NCT02170857|"~     The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment~     of periodontal pockets in people with gum disease.~      This research consists of clinical and radiographic studies. Participants should have~     symmetric periodontal pockets in the upper or lower jaw.~      Participants will be treated surgically using hyaluronic acid on one side of the jaw.~      Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken~     for each participant before surgical treatment and 12 months after surgical treatment.~   "
67727|NCT02170844|"~     To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS~     following oral administration of single rising doses from 50 mg to 350 mg in healthy male~     subjects of Japanese and Caucasian origin. This was the first administration of this~     substance to subjects of Japanese origin.~   "
67728|NCT02170831|"~     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.~   "
67729|NCT02170818|"~     Importance Team members speaking-up by raising concerns about inappropriate or unsafe~     actions of others within the team can have direct, immediate, and preventive effect on~     adverse outcomes. However, little is known about the hurdles and enablers of this behavior~     in healthcare, especially within the operating room setting.~      Objective~      1. Determine if an educational workshop would improve speaking-up behaviors of practicing~     anesthesiologists when presented with realistically-simulated clinical situations.~     2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3.~     Identify the self-reported hurdles and enablers for speaking-up in those situations~     encountered.~      Design Randomized controlled experiment of an educational workshop intervention on~     communication behaviors in a simulated case. Qualitative analysis of debriefing~     conversations following the simulated case.~      Setting Established academic simulation center~      Participants Seventy-one practicing anesthesiologists from four academic medical centers and~     one community hospital~      Intervention Fifty minute educational workshop on speaking-up that included rationale,~     conversational techniques, a rubric for speaking-up, and role-play.~   "
67730|NCT02170805|"~     The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule~     formulation using melt extrusion technology was assessed in two separate, single dose, 3-way~     crossover, open design, randomised studies. The 3-way crossover treatments included~     administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A~     or B and administration of the capsules with coadministration of pantoprazole.~   "
67731|NCT02170792|"~     To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without~     coadministration of 150 mg ranitidine.~   "
67732|NCT02170779|"~     This is a study to determine the impact of education and specific lower extremity stretches~     for MS-related spasticity. The study will evaluate the acceptance and efficacy of education~     and stretching using a randomized controlled pilot trial.~   "
67733|NCT02170766|"~     To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with~     and without coadministration of 40 mg pantoprazole.~   "
67780|NCT02170155|"~     Understanding the onset and progression of spinal cord disorders is an important aim in~     clinical neurology. An early diagnosis with consequent therapy might prevent the progression~     of disability. Therefore, we aim to determine structural and dynamic changes in the~     microstructure of the spinal cord and CSF, and to explore the relationships between the MRI~     parameters, clinical disability, and electrophysiology.~   "
67734|NCT02170753|"~     Purpose: The primary purpose of this study is to determine whether or not the addition of~     thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach~     consisting of motor control exercises and lumbar spine manual therapy is better than~     standard PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain~     intensity, disability level, and perceived change in patients with chronic low back pain~     (CLBP) and movement coordination impairments.~      Hypothesis: In a CLBP subgroup with movement coordination impairments, participants~     receiving thoracic, pelvic, and hip manual therapy with standard PT will be superior to~     participants receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain~     intensity, physical disability level, and perceived change at two, four, and 12 weeks after~     initiating treatment.~   "
67735|NCT02170740|"~     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters~     in healthy volunteer subjects.~   "
67736|NCT02170727|"~     To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed~     dose combination in Genotype 1 Chronic Hepatitis C subjects.~   "
67737|NCT02170714|"~     Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening~     event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a~     second line therapy. This study was performed in consecutively observed pediatric patients~     with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-~     European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)~     guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical~     predictors of poor outcome.~      Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative~     Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment~     through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,~     hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All~     patients were treated according to the above mentioned guidelines for ASC and received~     intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as~     second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy~     rate and the efficacy of IFX in avoiding colectomy were evaluated.~   "
67738|NCT02170701|"~     -  To determine the therapeutic window of BIBR 1048 in order to select doses for further~          studies in the development plan.~        -  Twice daily regimen will be tested for most dose levels and once daily administration~          will also be evaluated when appropriate.~   "
67739|NCT02170688|"~     There are several different methods that can be used to determine the dose of iodinated~     contrast material for a CT scan. These include a standard fixed dose, a dose based on total~     body weight, a dose based on body mass index, a dose based on lean body weight, and a dose~     based on estimated lean body weight. The fixed dose method uses a predetermined amount of~     contrast material for all patients having a CT scan of the abdomen regardless of size. This~     is the standard procedure currently used at Duke. The other methods use the patient's~     weight, either the total body weight or lean body weight, to determine the amount of~     contrast necessary for the CT exam. For this study, the investigators will use the fixed~     dose, total body weight, the lean body weight, and estimated lean body weight methods. The~     purpose of this study is to evaluate these five methods of determining the IV contrast~     volume and which may be best for abdominal CT scanning.~   "
67740|NCT02170675|"~     To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole~     affects plasma exposure of dabigatran.~   "
67741|NCT02170662|"~     The purpose of this study is to determine the effect of bimatoprost solution on scalp hair~     growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment~     of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is~     not approved for the treatment of scalp hair loss and its use in this study is considered~     investigational which means it is still being tested in research studies.~      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.~   "
67742|NCT02170649|"~     The purpose of this study is to investigate the effect of food on the pharmacokinetics of a~     single 800 mg oral dose of BIA 2-093 in healthy volunteers.~   "
67743|NCT02170636|"~     Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048~     bid over three days each administered as four experimental formulations relative to drinking~     solution with and without coadministration of 40 mg Pantoprazole~   "
67744|NCT02170623|"~     Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after~     administration of 50 mg of BIBR 1048 bid over three days each administered as two~     experimental formulations relative to drinking solution with and without coadministration of~     40 mg Pantoprazole.~   "
67745|NCT02170610|"~     To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule~     formulation with and without coadministration of 40 mg Pantoprazole and to assess the effect~     of food on rate and extent of absorption.~   "
67746|NCT02170597|"~     Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a~     150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after~     administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative~     bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without~     food.~   "
67747|NCT02170584|"~     Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1~     and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as~     'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of~     BIBR 1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the~     absolute bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.~   "
67748|NCT02170571|"~     Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the~     pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran~     etexilate. Determination of safety and tolerability of dabigatran upon administration to~     hepatically impaired patients and healthy subjects (matched pairs)~   "
67749|NCT02170558|"~     To determine if the subject metal reduction software helps to better visualize bone~     interphase and fusion reliability. Assess whether the appropriate procedural modification~     facilitates clearer images when implanted with a trabecular metal spinal implant~   "
67752|NCT02170519|"~     Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right~     ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective~     pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice~     for this condition. The evidence supporting INO safety and efficacy under these~     circumstances is sparse, however, and is largely extrapolated from the use of INO in~     neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes~     the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized~     prostacyclins such as iloprost may be a favorable alternative therapy.~   "
67753|NCT02170506|"~     Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It~     involves many brain areas, including primary motor and sensory areas. Its dysfunction,~     called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In~     this case, it is conventionally translated by a swallow response time delay of the~     swallowing reflex.~      Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function~     that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients~     with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain~     normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery~     appear to be related to a reorganization of the motor cortex intact. Patients who retain~     disorders are those who have not cortical reorganization.~      With this in mind a team used different methods known to modulate brain plasticity, which~     electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation~     increases the excitability of the cortico- bulbar reflex, which improves swallowing function~     in the clinical application.~      The hypothesis of this work is that the transcutaneous electrical stimulation applied~     submental, noninvasive technique, would also have an impact on cortical plasticity may~     explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) (~     Gallas , 2010).~   "
67754|NCT02170493|"~     The purpose of this study is to use a novel load monitoring technology to correlate limb~     loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first~     to collect continuous limb loading data and will provide the first objective insight into~     how limb loading directs fracture healing. To meet this purpose, two specific aims have been~     developed.~      Specific Aim 1: Preclinical validation of a load-monitoring insole~      The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load~     monitoring: development of load sensor technology that is affordable, accurate and capable~     of monitoring for over four weeks. To develop this sensor technology into a load-monitoring~     insole, the Hitchcock lab will incorporate consumer type electronics into the design,~     including a microprocessor, battery, and data storage media.~      Following construction of a functional load-monitoring insole, a pilot human study with~     orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify~     modes of device failure, improve device interfacing and develop data handling protocols and~     software for the clinical arm of the proposed study.~      Specific Aim 2: Conduct a prospective, direct observational cohort study.~      Thirty (30) open tibial fracture patients will be recruited at two centers: University of~     Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a~     walking boot instrumented with the load-monitoring insole that will continuously record limb~     loading and serve as a step counter. X-rays collected at standard-of-care follow-up visits~     will be used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A~     questionnaire regarding subjective perception of patient compliance will be collected at the~     first and last follow-up visits. Data collected from the insole sensor will be correlated to~     objective measures of fracture healing and subjective measures of patient compliance to~     determine the effect of patient limb loading on injury outcome. The Hitchcock laboratory~     will develop software to process and summarize data from the load monitoring insole and~     continually improve human interfacing factors of the load monitoring insole based off of~     feedback from the clinical team and study participants.~   "
67755|NCT02170480|"~     It has been the investigators observation that large diameter traction pins cause more~     postoperative knee pain than smaller traction pins. To the investigators knowledge, no study~     to date has identified knee pain as a consequence of traction pin placement. Furthermore, no~     study has identified whether pin size has an effect on the incidence of postoperative knee~     pain. The goal of the present study is to establish whether use of temporary skeletal~     traction is associated with subsequent knee pain and to determine whether traction pin size~     influences the incidence and/or magnitude of knee pain.~      Objective #1:~      Determine whether pin size influences the incidence and/or severity of postoperative knee~     pain in patients who undergo temporary skeletal traction.~      Hypothesis:~      Larger traction pins are associated with an increase in both the incidence and severity of~     postoperative knee pain.~      Objective#2:~      Determine whether pin size affects musculoskeletal function in the postoperative period.~      Hypothesis:~      There is no difference between small and large traction pins in postoperative~     musculoskeletal function.~   "
67756|NCT02170467|"~     In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier~     preventing the passage of toxic substances from the intestinal lumen to the blood stream.~     Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract~     profoundly affect small bowel morphology and physiology. Many reports have described~     alterations of ion and nutrient transport, mucosal atrophy and modifications in the~     intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in~     severe starvation. These changes may dampen both the absorptive and the barrier functions of~     intestinal mucosa.~      The assessment of intestinal permeability, by measuring the urinary excretion of substances~     that are not metabolised by human tissues and passively cross the intestinal epithelium, is~     a reliable and non invasive method to investigate the anatomo-functional integrity of the~     intestinal mucosa. Previous studies have shown an increase of permeability in malnourished~     humans . The increase of may also increase the risk for inappropriate passage of food~     antigens and other noxious substances across the mucosal barrier. To this regard, the~     enhanced susceptibility of malnourished subjects to systemic infections and postoperative~     sepsis has long been recognised.~      Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours~     aiming to decrease body weight. Typically, women with anorexia nervosa restrict food~     ingestion up to severe starvation. These behaviours usually lead to malnutrition and a more~     or less prolonged absence of luminal nutrients in the gastrointestinal tract. Therefore,~     alterations in the integrity and functioning of intestinal mucosa are likely to occur in~     this condition. There is no information on intestinal permeability in patients with eating~     disorders. We hypothesised that, as it occurs in simple starvation and malnutrition,~     intestinal permeability should be increased in fasted undernourished people with anorexia~     nervosa and decrease after re feeding. Therefore, in the present study, we explored~     intestinal permeability of 23 subjects with anorexia nervosa by means of the~     lactulose-mannitol test and urinary sucralose excretion and compare them to 46 controls.~      Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The~     origin of these auto-antibodies is still unknown , but some studies suggested a digestive~     origin. Moreover, modifications of intestinal flora have been described in patients with~     anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia~     nervosa is necessary. In this study, a comparaison of intestinal permeability and~     autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with~     anorexia nervosa.~   "
67757|NCT02170454|"~     The aim of this study is to test the hypothesis that rTMS on the dominant swallowing~     hemisphere is able to modify swallowing coordination.~   "
67758|NCT02170441|"~     The goal of this study is to evaluate time to diagnosis for three assays (line probe,~     pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect~     resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium~     tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively~     drug-resistant TB (XDR-TB).~   "
67759|NCT02170428|"~     The overall objective with the study was to contribute to the scientific basis for dietary~     and life strategies, policies and dietary guidelines to infants and young children in~     Denmark and with special focus on prevention of obesity and diet related chronic diseases~     such as type 2 diabetes, ischemic heart disease and osteoporosis.~   "
67760|NCT02170415|"~     Numerous surveys have shown that following breast surgery, longterm pain affects around half~     of patients. Given that 1 in 9 women will get breast cancer and that surgery is the~     cornerstone of treatment, persistent pain represents a major challenge. In addition to the~     suffering chronic pain causes to individual patients, the investigators know that it places~     a substantial burden on families and carers, and that patients with pain represent an~     excessive demand on healthcare resources.~      This research will evaluate the impact of introducing a proactive, integrated care plan for~     patients having breast surgery. It will assess the effect of the care plan on reducing the~     number of patients with pain at 3 and 12 months after their procedure.~      The personalised plan involves numerous evidence based steps linked by a single unifying~     description aimed at controlling pain, before, during and after the procedure, in hospital~     and at home.~      Patients at risk of developing pain will be identified prior to the procedure and randomly~     allocated to follow either the personalised care plan or to receive 'usual' care. In the~     personalised care plan group, participants will get information about chronic pain, be~     screened for pain and offered immediate treatment. During their procedure both the surgeon~     and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the~     likelihood of experiencing pain.~      After their procedure, patients will be again screened for pain and further treatment~     instigated. Physiotherapists and other allied health professionals such as psychologists~     will also be involved as appropriate. A package of care for pain will then be passed on to~     the patients' GP, in the form of a written pain management plan, for ongoing care which will~     be linked to the hospital. Patients from both groups will be followed up for a year at~     regular intervals.~   "
67761|NCT02170402|"~     The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in~     the treatment and prevention of bleeding episodes (BEs)~   "
67762|NCT02170389|"~     This pilot clinical trial studies vaccine therapy before surgery in treating patients with~     kidney cancer that has not spread to nearby lymph nodes or to other parts of the body.~     Vaccines made from a person's tumor cells and white blood cells may help the body build an~     effective immune response to kill tumor cells when they are infused back into the body.~   "
67763|NCT02170376|"~     The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50~     and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics~     (PK), in comparison to placebo and 200 mg entacapone (ENT).~   "
67764|NCT02170363|"~     The purpose of this clinical investigation is to evaluate the performance and safety of the~     HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the~     HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries.~     The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP~     and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with~     country-specific requirements, under one clinical study protocol.~      This study will evaluate the performance of the HM3 LVAS, side effects and undesirable~     conditions within acceptable risks and weigh them against the intended performance of HM3~     LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical~     Device Directive 90/385/EEC (AIMDD).~   "
67765|NCT02170350|"~     This pilot clinical trial studies how well brief mindful mediation practice works in~     improving quality of life in patients with cancer undergoing radiation therapy. Brief~     mindful mediation practice may improve the well-being and quality of life of patients with~     cancer who are undergoing radiation therapy by increasing levels of mindfulness and reducing~     stress, anxiety/depression, and fatigue.~   "
67766|NCT02170337|"~     A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects~     with chronic rhinosinusitis with nasal polyps~   "
67767|NCT02170324|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Excess expansion of WAT~     due to positive energy balance and defects in thermogenic gene expression in BAT are~     associated with obesity and various metabolic diseases. Until 2009 the question of whether~     adult humans had BAT and whether it could conceivably contribute to whole body energy usage~     in a meaningful way was a matter of vigorous debate. The publication of three apppers in the~     New England Journal of Medicine that demonstrated adult humans do have BAT, that it can be~     activated, and that this activation appears to be defective in obesity reframed the debate,~     and revived interest in BAT physiology. Recent studies also reveal the presence of a subset~     of cells in WAT that could be induced by environmental or hormonal factors to become~     ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong~     antiobesity and antidiabetic benefits.~      The extrapancreatic actions of glucagon-like peptide-1 (GLP-1) on endothelial cells and the~     liver have been reported. Additionally, effects of GLP-1 on adipose tissue have been~     described. Studies performed in isolated adipocytes have demonstrated that GLP-1 has the~     ability to induce both lipogenic and lipolytic mechanisms in white adipose tissue (WAT) .~     More recent study showed that GLP-1 agonism stimulates brown adipose tissue thermogenesis~     and browning through hypothalamic AMP-activated protein kinase (AMPK) in animal. However,~     there is no data clearly show that GLP-1 agonism stimulates browning of subcutaneous white~     adipose tissue (SWAT) in human obesity.~   "
67768|NCT02170311|"~     The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be~     investigated in patients with iron-deficiency anemia after administration of a single dose~     (100 mg, 500 mg, 800 mg or 1,000 mg iron).~   "
67769|NCT02170298|"~     The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural~     and behavioral subcomponents of self-control, that is cognitive control and reward~     functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.~      The investigators hypothesize that LDX is associated with 1a) decreased task-independent~     locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive~     control network; 2) increased LC connectivity with the cognitive control network and 3)~     improved task performance and self-control. The investigators will test their hypotheses on~     fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both~     univariate and connectivity analyses).~      The investigators will also assess change in brain activity with the LDX in the LC and~     ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to~     cognitive control and self-control dysfunction in ADHD.~      The investigators will use a repeated-measures, between-subject design to compare the~     effects of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT)~     on neural (fMRI) and behavioral correlates of cognitive control via a working memory and a~     reward - delay discounting task in adolescents and young adults.~   "
67814|NCT02169713|"~     The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the~     concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the~     safety and tolerability of the combined administration of solifenacin, mirabegron and~     tamsulosin HCl.~   "
67770|NCT02170285|"~     The purpose of this study is to test tDCS (transcranial direct current stimulation), a type~     of non-invasive brain stimulation, to determine whether it can improve motor function in~     children with perinatal stroke and hemiparesis. Children 6-18 years with imaging-confirmed~     perinatal stroke and functional motor impairment will be recruited. Children will be~     randomized (1:1) to receive sham or tDCS (20 minutes daily) during daily intensive,~     goal-directed motor learning therapy (90 minutes). Motor outcomes will be repeated at~     baseline, 1 week, and 2 months.~      Aim 1: Establish the ability of tDCS to safely enhance motor learning in children with~     perinatal stroke.~      Hypothesis 1: tDCS is safe and well tolerated in children.~      Hypothesis 2: Contralesional, cathodal tDCS increases motor functional gains measured by AHA~     at 2 months in children with perinatal stroke.~   "
67771|NCT02170272|"~     This pilot clinical trial studies a home-based lymphedema care program in improving~     lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program~     may help head and neck cancer survivors manage their lymphedema and improve their well-being~     and quality of life.~   "
67772|NCT02170259|"~     Introduction. Tension-type headache is a highly prevalent disorder with a significant~     socio-economic impact, affecting psychological aspects. This study aims to assess aspects~     pertaining to anxiety, depression, headache frequency and pain intensity.~      Subjects and methods. A clinical trial was conducted on 84 participants suffering from~     tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The~     first group received suboccipital soft tissue treatment (ST); the second group was treated~     with articulatory technique (AT); the third group was applied a combination of both~     techniques (ST and AT) and a forth group which served as control group. Treatment sessions~     were administered during four weeks, with a post-treatment assessment, and follow-up after~     one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA)~     to evaluate the effect of treatment on between and within-subject conditions and their~     interaction on reported depression, anxiety, and headache pain frequency and intensity.~   "
67773|NCT02170246|"~     This research project will study whether the drug telmisartan administered in conjunction~     with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The~     investigators are studying the effect of this treatment in people who have contracted HIV~     infection within the past three weeks, and thus have a form of HIV called acute HIV~     infection. The investigators will measure biological markers of immune activation in the~     blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs~     in affected patients.~   "
67774|NCT02170233|"~     The study aim is to examine point-of-care ultrasound findings, reliability, and ease of~     performance in association with fluid responsiveness for patients with severe sepsis and~     septic shock. The investigators propose a prospective observational research study of~     patients presenting to one of three Yale New Haven Hospital emergency departments, York~     Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for~     sepsis, severe sepsis or septic shock during their emergency department visit.~   "
67775|NCT02170220|"~     The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its~     metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of~     vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy~     participants.~   "
67776|NCT02170207|"~     The purpose of this survey is to evaluate the safety (that is, frequency of adverse events)~     and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of~     hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron~     Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute~     gastric mucosal lesion in daily medical practice.~   "
67777|NCT02170194|"~     There is no question that combat and domestic attacks can be stressful, and can have effects~     that last for months or even years, including reliving some of the events through nightmares~     or flashbacks, wanting to avoid anything that is a reminder of combat or domestic attack~     such as movies or the nightly news, or being jumpy and concerned about security. When~     someone has a lot of these symptoms they might be told they have PTSD, but even when that~     person doesn't have the full condition, just having some symptoms can affect their ability~     to function at the highest level at home, work, or in social settings, and puts you at~     greater risk for developing full PTSD. While someone who went through a significant~     stressful event might not need a long course of therapy if they don't have full PTSD, the~     investigator of this study thinks that working with them from a distance through their smart~     phone over time may decrease their symptoms, help them feel better, and prevent full PTSD.~     Thus the purpose of this study is to assess how a brief, relatively simple resiliency~     enhancement strategy, provided mostly through smart phones, affects someone with~     stress-related symptoms.~   "
67778|NCT02170181|"~     This prospective protocol will enroll patients with pathologically confirmed solid~     malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for~     consolidation after systemic therapy, prior to systemic therapy for the purposes of~     debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials~     in patients with malignancies of all histologies is being utilized in these settings.~     However, individualized outcomes and characteristics of treatments are not prospectively~     followed and not well documented. By instituting a registry of patients receiving SBRT in~     these settings it will be possible to determine trends in patterns of care and outcomes for~     refinement and justification of this treatment.~   "
67779|NCT02170168|"~     The overall aim of this project is to deliver better health care services through improved~     coordination of cancer care within specialist care (at the local hospital Orkdal Hospital)~     and community care (13 municipalities in the Orkdal region, Norway), and between these two~     levels in the health care system. The Orkdal model is developed and will be implemented~     and evaluated within cancer care. Cancer patients living in one of the 12 municipalities~     participating in the formal collaboration Samhandlingsenheten i Orkdalsregionen (SIO), or~     the municipality of Oppdal, having metastatic and/or loco-regional disease will be included~     in the study. Carers and health care providers will be included as well. Results from this~     project will be transferable to other parts of Norway and/or to other countries as well as~     to patients with other diagnoses causing complex conditions, such as chronic heart-, lung-~     and neurological disease.~   "
67781|NCT02170142|"~     The major goal of this project is to characterize the structural and functional development~     of cortical plate and white matter of the human neonatal brain from the equivalent 30~     gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535.~     Furthermore, it is related to the blue print project of transcriptome atlas (niH~     RC2MH089921) with at least 36 million funding also sponsored by niH.~      Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain~     not only aids in understanding this highly ordered process, but also provides clues to~     detect abnormalities caused by genetic or environmental factors. Cerebral vascular~     measurements offer important information on cerebral metabolism. However, either anatomical~     or functional studies of human brain development during this period are surprisingly scarce.~     Diffusion tensor imaging (DTi), a recently developed technology of magnetic resonance~     imaging (MRi), is capable of noninvasively delineating macroscopic anatomical components~     with high contrast and revealing structures at the microscopic level. Cerebral vascular~     quantification including cerebral blood flow (CBF) and cerebral metabolic rate of oxygen~     (CMRo2) can also be obtained through noninvasive MRi, specifically arterial spin labeling~     (aSL) and T2-relaxation under spin tagging (TRuST) MRi. in this proposed study, the~     structure and function of neonatal brain will be explored using noninvasive MRi~     technologies. 102 infants will be recruited and no sedation will be applied during MRi. The~     resultant database will provide reference standards for diagnostic radiology of premature~     newborns and reveal the vascular activities of these newborn brains. Specifically, three~     aims will be achieved:~        1. To delineate the anatomical development of complex structure in the cerebral wall and~          white matter tracts of neonatal brains at different equivalent gestational ages.~        2. To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.~        3. To correlate the structural and functional measurements with the gene transcriptome~          results.~   "
67782|NCT02170129|"~     Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase~     bone height in the atrophic posterior maxilla for dental implant placement. In bone~     reconstructive surgery, in general, autogenous bone is considered as the gold standard,~     primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are~     available that can overcome the limitations of autologous bone due to their osteoconductive~     properties and biocompatibility. Several studies seem to validate these concepts, but~     further comparative trials are needed.~      Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine~     bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral~     approach.~      Material and Methods: This study was designed as a randomised, controlled, clinical trial.~     Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been~     bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses~     were randomised according to a parallel group design. Sinuses were grafted according to a~     lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss)~     and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone~     (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants~     (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm.~     At same surgical procedure a sample of bone was harvested for histomorphometric analysis .~     All implants were delayed loaded with screw retained temporary crowns 3 months after~     implants insertion and with screw retained definitive crowns 4 months later. Outcome~     measures were implant survival, biological and prosthetic complications, radiographic~     marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12~     months. Statistical significance was tested at the 0.05 probability level, and all values~     were presented as mean and standard deviation.~   "
67783|NCT02170116|"~     The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR~     953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR~     1048 MS, in healthy male subjects. This was the first administration of this substance to~     humans.~   "
67784|NCT02170103|"~     The investigators propose to test the effectiveness of a technique that uses a modified~     commercially available ultrasound system used for cardiac imaging, and a commercially~     available ultrasound contrast agent (microbubbles) to break up the blood clots that cause~     heart attacks. The ultrasound and microbubbles will be applied as soon as possible to~     patients presenting to the emergency department, after an EKG confirms that a heart attack~     is ongoing. Patients who provide emergent consent will be randomized to either conventional~     therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The~     ultrasound will be applied both before and after emergent heart catheterization, in order to~     break up the blood clots that are not only in the artery supplying the heart muscle, but~     also in the small branches (capillaries) that are fed by this artery. Following the~     randomized treatment, patients will be followed for the development of any complications~     (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by~     echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment. A~     total of 250 patients will be enrolled and followed at two different sites. Randomization~     will be stratified at each study site. The initial site enrolling patients will be~     University of Sao Paulo Medical School. Wilson Mathias, MD, will serve as the principal~     investigator for this site. The other is VU University Medical Center in Amsterdam, where~     Otto Kamp, MD, will serve as the principal investigator.~   "
67785|NCT02170090|"~     This is a multicentre, prospective, randomized, controlled phase III trial designed to~     assess the clinical performance of gemcitabine with cisplatin and observation vs.~     observation alone in patients after curative intent resection of cholangiocarcinoma and~     muscle invasive gall bladder carcinoma.~   "
67786|NCT02170077|"~     The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of~     epileptic patients with refractory simple or complex partial seizures with or without~     secondary generalization.~   "
67787|NCT02170064|"~     The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate~     in children and adolescents with epilepsy.~   "
67788|NCT02170051|"~     This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive~     Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention~     better improves symptoms and functioning in people with schizophrenia.~   "
67789|NCT02170038|"~     The clinical phase I study aims at investigating the conversion of the contraceptive~     compound norethisterone within the body towards the contraceptive compound ethinylestradiol.~     Therefore concentrations of ethinylestradiol will be measured from blood samples after~     administration of a single intramuscular dose of norethisterone. In a comparison arm~     concentrations of ethinylestradiol will be measured from blood samples after administration~     of a pill containing ethinylestradiol itself.~   "
67790|NCT02170025|"~     Assessment of the safety, tolerability and early signs of efficacy of three times a day~     orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not~     on treatment with Orkambi~   "
67791|NCT02170012|"~     The purpose of this study in healthy elderly people is to evaluate safety, toleration and~     time course of plasma concentration of multiple oral doses of PF-06743649- The~     pharmacodynamic activity of PF-06743649 will also be assessed.~   "
67792|NCT02169999|"~     The purpose of this study is to determine the impact of web-based personalized decision~     support on:~        1. Patient awareness of treatment goal options and ability to articulate their goals of~          diabetes care.~        2. Provider awareness of patients' clinical status (e.g. life expectancy) and treatment~          preferences.~        3. Individualization of care plans in accordance with geriatric diabetes guidelines.~   "
67793|NCT02169986|"~     Forgetting is usually listed as the most important cause of low adherence among patients.~     Most studies to date have looked at the adherence of adults or adolescent population. No~     studies have been done looking specifically at adherence to topical treatment by~     parents/caregivers of young children. Our project will try to replicate the same results~     among the parents/caregivers responsible for children ten years and under. The population in~     this study will be the parents/caregivers of children 10 and under with atopic dermatitis~     and the intervention will be the effect of electronic reminders in adherence rates for the~     use of a moisturizer which is recognized as part of the standard of care in the treatment of~     atopic dermatitis.~   "
67794|NCT02169973|"~     The purpose of the study is to measure the uptake, distribution, and clearance of~     11C-MK-3168 by Positron Emission Tomography (PET) scan and to model the tissue specific~     kinetics of 11C-MK-3168 with the appropriate input function in human brain in Part A; to~     measure blocking of retention of 11C-MK-3168 at the estimated time to maximum plasma~     concentration after dosing (tmax) following each single oral doses of JNJ-42165279 and model~     the exposure/enzyme interaction of JNJ-42165279 in Part B; to measure the saturation of~     enzyme inhibition in the brain at steady state plasma concentrations of JNJ-42165279 (on Day~     8) after 7 once-daily doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at~     trough plasma concentrations on Day 2 in Part C.~   "
67795|NCT02169960|"~     The majority of addiction and mental health problems seen in adults present first in youth.~     There is strong evidence that prevention and early identification during childhood can~     mitigate some of these risks. Students who screen at risk for the development of mental~     illness will be offered online intervention programs with personal guidance from a trained~     coach. In addition, lessons revolving around resiliency will be provided to all students.~      The objectives of this study are:~        -  Decreased rates of depression and suicide (as well as rates of suicide attempts)~        -  Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits~          such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer~        -  Decreased school drop-out rates Decreased rates of interactions with the justice system~        -  Decreased costs across a range of ministries (health, education, justice, human~          services), both for youth as well as their families who have been involved in this~          program~   "
67796|NCT02169947|"~     The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study~     in rural, African American adults of faith. The study will see whether a weight loss +~     maintenance intervention will cause participants to maintain their weight better than a~     weight loss only intervention.~   "
67797|NCT02169934|"~     The purpose of this study is to determine the routes of excretion for TRV130 and it's~     metabolites, and to determine and characterize, structurally, the metabolites present in~     plasma, urine, and feces in healthy male subjects.~   "
67798|NCT02169921|"~     The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for~     the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the~     popliteal arteries with the Japanese population.~   "
67799|NCT02169908|"~     The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy~     has been previously described in mice and in neuronal cell cultures (Massicot 2013);~     clinical manifestations and pathophysiological mechanisms potentially involved have also~     been described in humans (Andreas 2007) (Attal 2009).~      The investigators team plans to conduct a translational clinicobiological research to~     explain the nature of the biochemical and molecular mechanisms of the development of~     oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose~     to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted~     in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion~     of 20 patients.~      The main objective of this pilot study is to evaluate the occurrence of acute and chronic~     neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization~     of this pain is based on validated tests (Cruccu 2010).~      Moreover, the biochemical changes related to oxidative stress and those related to cellular~     lipid composition are characterized in these patients.~   "
67800|NCT02169895|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)~   "
67801|NCT02169882|"~     Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high~     mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key~     drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose~     may be more effective.~      There are several highly relevant, outstanding questions related to the appropriate dose of~     rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:~        1. Previous phase 2a randomized clinical trial (done in the same setting as this proposed~          study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for~          TBM is safe and associated with a survival benefit in adults. Given that i.v.~          rifampicin is not readily available, this needs to be confirmed using an equivalent~          higher oral dose of rifampicin.~        2. Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v.~          rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may~          be needed; but this has not been examined~        3. Based on those previous data, there is a need to explore a longer duration of high-dose~          rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in~          the investigators previous trial suggest that the optimal duration may be > 14 days.~        4. There is a need to explore relevant treatment endpoints besides mortality including~          neurological, neuroradiological and inflammatory response.~   "
67812|NCT02169739|"~     Previous studies in animals and humans has shown that brief periods of reduced blood flow to~     one organ or tissue in the body can help protect other tissues from subsequent injury caused~     by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic~     preconditioning and may help protect brain cells after a stroke. The investigators are~     studying a specific stroke type called subcortical stroke that is very common and has a high~     rate of recurrent stroke and cognition problems despite intensive prevention measures.~   "
67813|NCT02169726|"~     Back injuries are the most common reason people seeking for effective treatment. One of the~     most common treatments in sports medicine for muscular injuries is therapeutic ultrasound,~     which is designed to heat the injured tissue and increase the flow of blood to promote~     healing.~   "
67802|NCT02169869|"~     The study will be a randomized clinical trial. Women with less than 10 prenatal visits~     and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered~     for enrollment. If consented and meet inclusion criteria, they will be randomized after~     delivery to receive an IUD immediately postplacental or at their routine postpartum visit.~      Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon~     Health and Science University (OHSU) hospital will be considered for inclusion in the study.~     Women who desire an IUD for postpartum contraception will be approached for study~     participation. The postpartum contraception plan is routinely documented during their~     prenatal course. It is also addressed by the obstetrical team upon admission to Labor &~     Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet~     the criteria of poor prenatal clinic attendance and express interest in intrauterine~     contraception. Immediately after vaginal or cesarean delivery, consented subjects will be~     randomized to immediate postplacental IUD placement or IUD placement at their routine~     postpartum visit. Women randomized to the immediate postplacental IUD group will receive~     their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital~     women who received a postplacental IUD will be assisted in scheduling a routine postpartum~     visit with their primary provider. Subjects who are randomized for IUD insertion at their~     postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with~     their usual obstetrical care provider. All subjects in the delayed group will be provided~     with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject~     cannot obtain an IUD at her usual place of care, the device will be placed at no cost~     through the WHRU.~      At 3 months after delivery, all subjects will be contacted by phone, text, or email to~     complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or~     elective IUD removal. The questionnaire will include questions regarding ease of placement~     and overall satisfaction with the timing of placement. Subjects will be compensated for~     their participation in the study after the 3 month contact.~   "
67803|NCT02169856|"~     In our study the investigators want to evaluate the effects of EFTs (emotional freedom~     techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects~     of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it~     will be much valuable adjunct to postoperative management of the patients.~      Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of~     postoperative nausea and vomiting after laparoscopic cholecystectomy.~   "
67804|NCT02169843|"~     Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can~     inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction~     in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of~     emergence agitation of children and adults,especially in elderly patients(>64 years) after~     using sevoflurane anesthesia.~   "
67805|NCT02169830|"~     The investigators' study plans to randomize treatment naive patients with vestibular~     migraine to an 8 week trial of an escalating dose of either nortriptyline or topiramate~     followed by an 8 week crossover to the other drug if patient is willing, if patient wants to~     stay on first medication we will just continue to follow. During the first 8 weeks if there~     is an intolerance to the first drug they can be switched to the other drug at any point and~     then followed on that medication for the remainder of the study. Response to therapy will be~     quantified by the Migraine Specific Quality of Life (MSQ) and Dizziness Handicap Inventory~     (DHI) administered at multiple time points during the study. Three groups of patients that~     will be eligible for the study will include 1)Patients with Neuhauser dVM; 2)Patients with~     pVM; and 3) Patients with dizziness that falls outside the Neuhauser criteria (non-Neuhauser~     vestibular migraine or nNVM).~      The investigators' hypothesis is that even patients with dizziness outside of the Neuhauser~     dVM and pVM spectrum will respond to treatment for vestibular migraine, and thus likely have~     migraine as a cause of their dizziness. Previous research by our group has suggested that~     such patients do in fact respond to migraine therapy1. A second goal of the study is to~     evaluate the comparative efficacy of nortriptyline and topiramate in the treatment of these~     three subgroups of patients with vestibular migraine.~   "
67806|NCT02169817|"~     Primary Objective:~      To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain~     (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days,~     in the duration of acute community-acquired diarrhea in Latin American children.~      Secondary Objectives:~      To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to~     demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting~     episodes.~      To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of~     Enterogermina in norovirus acute gastroenteritis (AGE).~   "
67807|NCT02169804|"~     • To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly~     healthy adult male subjects.~   "
67808|NCT02169791|"~     In an attempt to reduce relapse risk and improve outcomes following haploidentical~     transplantation for patients with high risk hematologic malignancies, the investigators will~     implement several strategies to augment the well documented effect of NK cell alloreactivity~     seen in HLA-mismatched transplantation. These strategies include (1) choosing potential~     haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition~     post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect~     against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the~     post-transplant immunosuppression regimen to improve NK cell reconstitution following~     haploidentical peripheral blood stem cell transplantation.~   "
67809|NCT02169778|"~     Obesity has become a global epidemic with huge public health implications. Although clinical~     significant weight loss can be achieved by a combination of diet and behavioral~     modification, strong metabolic adaptations, with increased appetite and suppressed energy~     expenditure, are activated, which compromise weight loss maintenance and increase the risk~     of relapse. The aim of this project is to compare the effects of intermittent versus~     continuous energy restriction on the compensatory responses previously described using two~     low calory diets, with a similar macronutrient distribution. More specifically, this study~     will analyze, in the short-term, if an intermittent energy restricted diet is associated~     with less appetite and low reduction in energy expenditure when compared with a continuous~     energy restricted diet. This project can bring large practical benefits concerning the~     design of weight loss programs to minimize weight relapse.~   "
67810|NCT02169765|"~     Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is~     important to explore a safe and effective therapy for early-stage HCC. Previous studies~     reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer~     complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC.~     However, meta-analysis and systematic review found that RFA is associated with higher~     recurrence rate and lower long-term overall survival.~   "
67811|NCT02169752|"~     This research study is looking at the use of the drug ambrisentan and if it can improve~     right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial~     hypertension. It is also looking at using right ventricle function changes as a marker of~     disease severity.~   "
67815|NCT02169700|"~     Myofascial trigger points (MTrPs) are identified through physical examination as~     hypersensitive spots within taut bands of skeletal muscle, painful on compression,~     triggering characteristic referred pain and generating motor dysfunction as well as~     autonomic phenomena. Different dry needling procedures have been described in the treatment~     of MTrPs. Needling therapies which consist in partially inserting and withdrawing the needle~     from the trigger point site in order to elicit local twitch responses are associated with~     higher effectiveness in releasing MTrPs. Deep dry needling has obtained a grade A~     recommendation compared to sham, for immediate reduction of pain in patients with~     upper-quadrant myofascial pain syndrome. Nevertheless, trigger point dry needling are~     frequently associated to a post-needling soreness. The application of ischemic compression~     (IC) after trigger point injection in the upper trapezius muscle has shown higher reduction~     of pain and disability in myofascial pain patients, compared with trigger point injection~     alone. To the authors' knowledge, no previous studies have evaluated the effectiveness of IC~     or any manual therapy methods for the treatment of post-needling soreness. The aims of this~     study were: (a) to evaluate the effectiveness of IC on reducing post-needling soreness after~     dry needling of one latent MTrP in the upper trapezius muscle, and (b) to investigate the~     effect dry needling combined with IC, compared to dry needling alone and dry needling~     combined with placebo IC will have on cervical range of motion (c) to determine whether~     psychological factors are predictive of postneedling pain and (d) to analyze if the~     relationships between psychological variables and postneedling pain varied as a function of~     postneedling soreness treatment~   "
67816|NCT02169687|"~     The purpose of this study is to assess the efficacy and safety of High Intensity Focalized~     Ultrasound (HIFU) in the treatment for toxic Thyroids nodules~   "
67817|NCT02169674|"~     This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with~     Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B~     disease. Adolescents will be invited to have a blood test and those without a minimal level~     of protection (antibody titer) will be offered a test vaccination to see if they still~     have capacity to recall an immune response. About one month later they will get another~     blood test to see if a booster response occurred. A few participants will have lost~     protection (no booster response) and will be offered a second HB vaccination to restore~     protection. Results of this study could influence the way in which children in British~     Columbia (BC) are immunized against HB disease.~   "
67818|NCT02169661|"~     Consumption of ready meals and other convenience foods are rapidly increasing. However,~     their nutritional value is problematical. For example, many are high in fats which are~     potentially oxidisable resulting in the formation of toxic end products. Consequently the~     aim of this study is to assess whether consumption of ready meals rich in certain fats~     leads to a post-prandial increase in lipid oxidation products in plasma and whether this can~     be ameliorated by reformulating the meals with natural extracts rich in phytochemicals with~     potential antioxidant activity in the stomach~   "
67819|NCT02169648|"~     The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by~     determining the pathogenesis of macular edema, which cause a direct effect on visual~     function. In particular, we focus on the correlation between the treatment effectiveness of~     ranibizumab and the role of the cytokines involved in the cause of macular edema.~   "
67820|NCT02169635|"~     High myopia is characterized by prolonged axial length and posterior staphyloma, which~     result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead~     to anatomical improvements, but an higher axial length and the presence of a sever posterior~     staphyloma remains to be the two most important risk factors for poor visual outcomes. For~     these reasons, a different surgical approach, including macular buckling, might be~     considered in those patients with extremely high degree of myopia, in order to counteract~     the traction exerted by the posterior staphyloma. Macular buckling with or without pars~     plana vitrectomy had been proved to be an effective way to resolve myopic staphyloma related~     foveoschisis, macular hole, and associated retinal detachment. In this study, we sought to~     investigate the safety and efficacy of a macular buckling technique using a three-armed~     silicone capsule to support the posterior staphyloma in high myopia.~   "
67821|NCT02169622|"~     Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass~     graft operations. How often this happens and what other problems occur for a person after~     these operations needs to be better understood. This study uses a device called the Reveal~     XT, a small device that records heart rhythms to track a patient's heart rhythms after the~     bypass surgery. The device is implanted at the time the bypass graft is made. The~     information that is gathered for this study will help physicians to provide better treatment~     and follow-up of the patients under their care.~   "
67822|NCT02169609|"~     The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal~     antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or~     RA) in patients with high-risk neuroblastoma.~   "
67823|NCT02169596|"~     Background~      Acute coronary syndrome (ACS) is a term representing all diseases related to reduction in~     blood flow to the heart characterised by clot formation over a segment of blood vessel~     narrowing. A major constituent of clot are blood cells called platelets and many of the~     medications used in ACS target platelet function. Ticagrelor is known to reduce platelet~     activity in clot formation by blocking a specific step in the process (P2Y12 receptors). A~     recent study has found that the presence of ticagrelor may also reduce clot formation by~     significantly enhancing another process involving the molecule nitric oxide (NO). This is of~     particular interest if translates into clinical practice, as many patients with heart~     disease have abnormal function of their blood vessel lining. This is known to cause a~     reduction in available nitric oxide. Does this therefore mean these patients will have a~     reduced response to ticagrelor therapy and subsequently be at increased risk of clot~     formation?~      Aims~        1. Will ticagrelor increase the anti clot effect of vessel lining produced nitric oxide?~        2. Do patients with diabetes or smokers, who have poor function of their vessel lining,~          have a reduced response to ticagrelor?~      Methods~      This is a pilot study in which we propose to look at 64 patients with known disease of their~     heart blood vessels, with an equal mix of smokers, diabetics, smoking diabetics and non~     smoking non diabetics. We will also recruit ten healthy normal subjects to ensure that our~     tests produce the same results as the basic science study mentioned above.~      To answer the questions posed we will perform blood tests, primarily looking at platelet~     function, and non-invasive blood vessel lining assessment. This will be done before and~     after ticagrelor treatment on each participant, enabling statistical comparison.~   "
67837|NCT02169414|"~     The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg)~     in steady-state conditions on the levodopa pharmacokinetics of a single dose of~     immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release~     levodopa/benserazide 100/25 mg.~   "
67824|NCT02169583|"~     This will be the first time GSK1325756 Solution for Infusion formulation that has been~     administered to humans. Prior studies have been performed with oral GSK1325756. The primary~     objectives of this study are to obtain information on the safety, tolerability, and~     pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of~     GSK1325756 in healthy subjects. In Part A, single, escalating doses will be given in the~     same cohort of subjects after a seven day washout. In addition, the study will evaluate the~     absolute bioavailability of a single dose of the current oral tablet formulation as compared~     to the IV formulation in Part A. In Part B, twice daily (BID) intravenous dose~     administration will be given for 5 days (9 total doses) in two separate cohorts of subjects.~     Data from this study will provide understanding of the safety, tolerability, and PK of~     intravenously administered GSK1325756 twice daily to guide dose selection in future clinical~     studies in patients with viral respiratory tract infections~   "
67825|NCT02169570|"~     Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a~     major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and~     people suffering from DM are more prone to catch TB as compared to healthy individuals. This~     concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM~     co-occurrence results in various clinical issues as TB in DM patient increases blood~     glucose, making DM more difficult to treat, while DM raises the risk of treatment failure,~     relapse and death among TB patients. In addition, both DM and TB usually coexist with~     micronutrients deficiencies like vitamin D, which has a vital role in immunity, insulin~     functioning and respiratory health. It has been suggested that the combined supplementation~     with vitamin D and calcium might be beneficial in improving the glucose metabolism but the~     current knowledge is very limited. In a resource restrained country with double burden of~     infectious and non-infectious diseases, an integrated approach with modification of~     treatment options may benefit in management of these outbreaks.~      Therefore, this study aims whether vitamin D and calcium supplementation could influence the~     recovery in patients with TB of lung and DM.~   "
67826|NCT02169557|"~     The purpose of this study is to demonstrate the treatment success of fexinidazole, at one~     year follow-up visit, in HAT stage 1 and early stage 2 patients.~   "
67827|NCT02169544|"~     The purpose of this study is to evaluate the risk of infections and malignancies among~     Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.~   "
67828|NCT02169531|"~     Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized~     by insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that~     liver would be the primary organ responsible for the metabolic disorder because of some~     unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading~     to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the~     pancreas to eventually exhaust their ability to produce and secret sufficient amount of~     insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and~     correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and~     secret growth factors which would help endothelial cells of blood vessels to reproduce and~     grow, resulting in reduced arteriosclerosis.~   "
67829|NCT02169518|"~     The incidence of coronary heart disease (CHD) is significant in the super-obese and~     diabetics.~      Inflammation is believed to play an important part in the development of CHD, and the large~     collection of abdominal fat in the obese person is a vast source of inflammation. Diabetics~     have abnormal glucose and cholesterol metabolism which ultimately compromise their bodies'~     circulatory system and nerve function.~      Cholesterol plays a vital role in CHD. Low-density lipoprotein (LDL) particles carry~     cholesterol and deposit it in blood vessel walls which become damaged as a result. When LDL~     particles undergo changes chemically (called oxidation) or as a result of high circulating~     blood glucose (called glycation), they become more harmful to the body. High-density~     lipoprotein (HDL) particles have a protective function in CHD. Not only do they transport~     cholesterol away from the blood vessels to the liver to be broken down, they have properties~     against oxidation and inflammation. These properties are related to the activity of an~     enzyme on HDL called paraoxonase 1(PON1).~      Super-obese patients are increasingly treated by weight-reducing surgery (bariatric~     surgery). In this study we examine whether weight loss following bariatric surgery results~     in reduced inflammatory state, improved HDL function (higher PON1 activity), better control~     of blood glucose and less nerve damage.~      We will study PON1 activity, inflammation and glucose control in patients with type 1~     diabetes (with and without kidney damage) and type 2 diabetes. We will also study the~     effects of rapidly rising blood glucose levels on PON1 and glycated LDL in patients~     undergoing oral glucose tolerance test.~   "
67830|NCT02169505|"~     The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab~     vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or~     haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab~     vedotin can help to prevent the disease from coming back.~   "
67831|NCT02169492|"~     The main objective of this study is to assess the safety and effectiveness of the ReVive SE~     (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy~     when used according to its Instruction for use (IFU).~   "
67832|NCT02169479|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)~   "
67833|NCT02169466|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).~   "
67834|NCT02169453|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 100/25)~   "
67835|NCT02169440|"~     The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the~     assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.~   "
67836|NCT02169427|"~     The purpose of this study is to determine the rate and routes of excretion of OPC and the~     mass balance in urine, faeces and expired air.~   "
67840|NCT02169375|"~     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for~     controlling electronic devices using only brain signals. Often, the computer software that~     analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals~     when the training target location is known. The investigators want the BCIs to be more~     universal, and not depend on knowing the target location. Therefore, the investigators will~     test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.~   "
67841|NCT02169362|"~     The study will examine the safety of using a concentration of proteins from a patient's own~     blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn~     wound.~   "
67842|NCT02169349|"~     The purpose of this study is to develop an ultra sensitive assay of mutation detection on~     circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of~     Non-Small Cell Lung Cancer (NSCLC).~   "
67843|NCT02169336|"~     The primary objective of this study is to evaluate the analgesic efficacy of two dose levels~     of DEX-IN compared with placebo, using the summed pain intensity difference over the first~     48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral~     bunionectomy.~   "
67844|NCT02169323|"~     There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled~     corticosteroids (ICS) than eosinophilic asthmatics.~      As non-eosinophilic asthmatic patients are treated by ICS according to international~     guidelines for asthma, the investigators would like to investigate whether stepping-down of~     ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a~     progressive cessation of ICS is possible in some of these patients without any clinical~     worsening.~   "
67845|NCT02169310|"~     Background:~      - People with a traumatic brain injury (TBI) can have trouble making the best possible~     decisions. Researchers want to learn more about the parts of the brain that control decision~     making. They also want to know how these are different between people. This may help predict~     how people make decisions after TBI.~      Objective:~      - To learn more about which parts of the brain are involved in making decisions and how~     decisions may be hurt after TBI.~      Eligibility:~      - Adults age 18 to 60.~      Design:~        -  Participants will be screened with medical history and physical exam. They will also~          take memory, attention, concentration, and thinking tests.~        -  Participants will do up to 2 experiments.~        -  For Experiment 1, participants may have 3 scans:~        -  PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a~          bed that slides in and out of the scanner.~        -  MRI: a strong magnetic field and radio waves take pictures of the brain. Participants~          lie on a table that slides in and out of a metal cylinder. It makes loud knocking~          noises. Participants will get earplugs. They might be asked to do a task. A coil will~          be placed over the head.~        -  MEG: a cone with magnetic field detectors is lowered onto participants head.~        -  After the scans, participants will perform a decision-making task.~        -  For Experiment 2, participants will perform a decision-making task before and after~          receiving transcranial direct current stimulation (tDCS).~        -  tDCS: wet electrode sponges are placed over participants scalp and forehead. A current~          passes between the electrodes. It stimulating the brain.~        -  Participants will return 24-48 hours later to repeat the decision-making task.~   "
67846|NCT02169297|"~     The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia~     technique developed at the investigators institution, as part of a quality improvement~     initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients.~     The investigators hypothesized that the local anesthetic infusion via bilateral~     multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location~     under ultrasound guidance would significantly improve pain control, as reflected by the~     decrease in pain intensity score, reduction in opiate requirement and improvement~     infunctional rehabilitation measure scores in patients who underwent the Nuss procedure for~     pectus excavatum repair. However, the goal of this pilot study was not to detect a~     statistically significant difference in the primary outcomes between control and treatment~     groups (as the number of study subjects was chosen out of necessity of what could be~     completed within a specified time period), but to estimate the parameters which allows~     appropriate power and sample size calculations for a future multi-institutional study.~   "
67847|NCT02169284|"~     This randomized phase II trial studies how well erlotinib hydrochloride works in treating~     patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
67848|NCT02169271|"~     This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating~     high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be~     malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep~     cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from~     forming in patients with subsolid lung nodules.~   "
67849|NCT02169258|"~     1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is~          high in patients who have low extremity artery disease (LEAD).~        2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA)~          remains poor and CAD is an independent predictor of total mortality after PTA.~        3. This prospective randomized controlled trial will evaluate the prognostic effects of~          routine versus selective coronary angiography before PTA for LEAD and elucidate the~          potential mechanism.~   "
67850|NCT02169245|"~     The objectives of the research are to assess the effects of increased protein and fiber~     intake at breakfast on neural activation in brain regions associated with appetitive drive~     and reward-driven eating, measures of subjective appetite, and ingestive behavior in~     overweight adults. Additional outcomes of interest include the effects of the breakfast~     intervention on blood sugar and cholesterol profiles.~   "
67889|NCT02168738|"~     The purpose of this study is to compare three lipidic forms of DHA in their metabolic~     pathway in human by using 13C labeled molecules.~      The circulating form of DHA plays a major role in his cerebral incorporation. The aim of~     this research is to confirm that some lipidic forms are best carriers for the cerebral~     incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.~   "
69084|NCT02153086|"~     The purpose of this survey is to examine the safety and efficacy of long-term use of~     ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep~     associated with insomnia in daily medical practice.~   "
67851|NCT02169232|"~     Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic~     bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an~     airway while a patient is awake, has many limitations. The video laryngoscope is a device~     that is similar to a conventional laryngoscope but uses a video system to visualize the~     larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or~     bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be~     useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic~     bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal~     intubations in of obese patients. Patients undergoing laparoscopic gastric bypas~     andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or~     video assisted laryngoscopy. The investigators primary outcome will be the time required for~     successful intubation.~   "
67852|NCT02169219|"~     The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,~     combined with rituximab, is effective in treating ANCA-associated vasculitis.~   "
67853|NCT02169206|"~     This study on frozen shoulder addressed the null hypothesis that there is no difference in~     the motion of scapula against the thoracic wall between affected and non-affected shoulder.~   "
67854|NCT02169193|"~     Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently~     occurs in intubated critically ill patients, and plays a major role in the pathogenesis of~     ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would~     be useful in diagnosing microaspiration of gastric contents in intubated critically ill~     patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of~     microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good~     diagnosis marker of microaspiration compared to the gold standard.~   "
67855|NCT02169180|"~     The purpose of this study is to evaluate overall response rate (ORR) (complete response [CR]~     rate plus partial response [PR] rate) of ibrutinib (IMBRUVICA™; PCI-32765; JNJ-54179060), as~     assessed by an Independent Review Committee (IRC), in participants with relapsed or~     refractory mantle cell lymphoma (MCL-a cancer of the lymph nodes or tissues).~   "
67856|NCT02169167|"~     Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from~     diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral~     neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers~     with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and~     ischemic etiology. Ulceration of lower limb is one of the most common complications related~     with diabetes and one of the major causes for hospitalization of diabetic patients. The most~     significant contributors to diabetic lower limb ulceration are neuropathy, deformity,~     uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease,~     male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous~     burden on health care resources worldwide, and at least 33% of all expenses are spent to~     treat diabetic ulcers manifested as a complication of diabetes.~      Although at least 170 topical wound care products are available, evidence of the superiority~     of one over another is tenuous, well-designed randomized, controlled trials are rare, and~     the number of case-control or observational studies is limited. In recent years, salve~     prepared from Norway spruce (Picea abies) resin has successfully been used in medical~     context to treat both acute and chronic wounds and ulcers of various origins. The objective~     of this prospective, randomized and controlled clinical trial is to investigate healing rate~     and healing time of neuropathic diabetic foot ulcer in patients, who are suffering from~     infected fore- or mid-foot ulceration (PEDIS-classification ≥ Grade II; 19) originated from~     Type I or II diabetes, and in patients whose diabetic ulcerations are candidates for topical~     treatment with resin (Study treatment) or octenidine (Control treatment). In addition,~     factors contributing with delayed healing of ulceration, antimicrobial properties, safety~     and cost-effectiveness of the resin salve treatment and control treatment will be analyzed.~   "
67857|NCT02169154|"~     This research study is being conducted to investigate the skin irritancy potential of a new~     medication which contains two active ingredients (diclofenac and menthol) together in a gel~     formulation and is being developed to treat mild to moderate pain and inflammation, such as~     acute sport injuries, sprains and strains.~   "
67858|NCT02169141|"~     This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and~     Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).~   "
67859|NCT02169128|"~     Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life~     threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles.~     Approximately 40% of all patients with infections caused by S. Pyogenes develop a~     streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite~     of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage~     on soft tissues and high risk of death, the microbes are called flesh-eating bacteria. The~     present study is a spin-off of the larger EU funded INFECT study, looking at the experiences~     of patient and family to understand the impact on every day life. The present prospective~     mixed methods study has the potential to provide important knowledge regarding the~     occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after~     diagnosis, and how the care and treatment can be optimized and organized in a person/patient~     and family centered way. The study also aims at validate the SF 36 questionnaire for this~     group of patients.~   "
67860|NCT02169115|"~     Urticaria is a very frequent skin condition characterized by transient wheal and flare type~     skin reactions associated with severe pruritus. In Europe alone, more than 5 million~     patients are thought to suffer from persisting urticaria symptoms, which either occur~     spontaneously, i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental~     physical stimuli such as friction, pressure, UV irradiation or cold (physical urticaria).~     Urticaria factitia (also known as dermographic urticaria and symptomatic dermographism) is~     characterized by whealing and itching following a minor stroking pressure, rubbing or~     scratching of the skin. The majority of patients with urticaria factitia benefits from~     treatment with nonsedating antihistamines. Some patients, however, do not achieve adequate~     symptom control even with updosing of antihistamines and may suffer from substantial quality~     of life impairment . Since even very minor stroking of the skin can lead to the development~     of wheals and severe itching, these patients are for example limited in their choice of~     clothing and are impaired in their social interaction and partnership.~      In all patients with a history of wheals after stroking of the skin, a provocation test~     should be performed. This can be done by stroking of the skin lightly with a smooth blunt~     object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built~     instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the~     smooth blunt object should be held perpendicular to the skin and should be used to apply a~     light stroking pressure to the skin of the upper back or volar forearm. The reaction is~     considered positive in patients who show a weal response and report pruritus at the site of~     provocation.~      Patients with a positive test reaction should be evaluated for individual pressure~     thresholds. For this purpose a provocation device (FricTest) has been developed that allows~     for reproducible and standardized threshold testing. Threshold testing enables physicians to~     assess disease severity and treatment response more precisely.~   "
67979|NCT02167555|"~     Primary objective is to characterize the relative bioavailability and kinetic profile of~     wild blueberry polyphenols over 24-hours period.~      Secondary objective is to examine the relationship between bioavailability and kinetic~     profile of wild blueberry polyphenols on markers of chronic diseases.~   "
67861|NCT02169102|"~     Anxiety, pain and discomfort are common stressful situations that occur during the dentistry~     practice, especially in the urgency endodontic practice. Studies have concluded that low~     intensity laser therapy is effective in treating pain. However, most studies have reported~     the low intensity laser therapy in chronic pain, few studies have shown its application on~     acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain~     of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be~     surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than~     usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always~     completely effective. Thus, this present study aims to evaluate whether previous therapy~     with low intensity laser could, by its analgesic effect, promote greater comfort especially~     to this type of patient. 60 patients with acute pulpits pain will be selected to this study~     (randomized and double-blinded) and they will be divided in 4 groups:~      Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40~     milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group~     3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated~     points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.~      The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial~     pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham~     laser irradiation). After that, patients with acute pulp irreversible inflammation will be~     submitted to conventional endodontic urgency treatment. Data concerning the need of~     complimentary local anesthesia will be also taken into account. Data of different groups and~     times will be statistically compared.~   "
67862|NCT02169089|"~     Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of~     the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries.~     High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role~     in developing clinical symptoms of atherosclerosis disease. The complications of advanced~     atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack,~     stroke and/or death and blockage of arteries.~      This study is being done to assess the effectiveness of Spironolactone therapy to slow down~     the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a~     large vessel coming out of your heart) compared to placebo (look alike sugar pill). This~     will be checked by comparing before and after therapy magnetic resonance imaging (MRI)~     pictures of your aortic wall.~      Spironolactone is an FDA approved drug used to treat heart failure and in the management of~     hypertension (high blood pressure), but in this study it is used for another unapproved~     reason. In this study, we would like to evaluate the effects of Spironolactone in people~     with diabetes and atherosclerotic disease.~   "
67863|NCT02169076|"~     Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly~     being implanted in patients with severe heart failure which have failed medical therapy. In~     patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is~     a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy~     (CRT) aims to restore the synchronized contraction of the heart and has proven to be~     beneficial for improving ejection fraction of both right and left ventricle as well as~     quality of life in selected heart failure patients. The role of CRT in patients with LVADs~     is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular~     function in LVAD patients and improve their quality-of-life.~      The specific questions that this study aims to answer are:~        1. What are the effects of CRT on the function of the non-supported right ventricle in~          patients with an implanted LVAD?~        2. Can the effects of CRT on cardiac function positively impact quality-of-life and~          exercise capacity in LVAD recipients?~      In this study patients with a previously implanted CRT device, who later receives an LVAD,~     will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients~     will be followed for an 8-week period, and then switched over to the opposite CRT status.~     The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic~     visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final~     visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart~     function will be assessed with comprehensive echocardiographic studies during the CRT on~     and CRT off periods. Quality-of-life and exercise capacity will be assessed with a~     standardized questionnaire and a 6-Minute Walk Test.~   "
67864|NCT02169063|"~     This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron~     emission tomography (PET) as a biomarker of treatment response in patients with prostate~     cancer that does not respond to treatment with hormones and has spread to other parts of the~     body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be~     useful in evaluating prostate cancer activity in response to treatment. Comparing results of~     diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done~     before and after therapy may help doctors predict a patient's response to treatment and help~     plan the best treatment.~   "
67865|NCT02169050|"~     Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D~     status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent~     rickets; however, recently it has been recognized to inversely associate with many~     non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro~     studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains~     unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing~     inflammation in human adipose tissues. The main objective of this study was to assess the~     association between vitamin D and insulin sensitivity and inflammation in morbidly obese~     pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at~     Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery~     clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity~     (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis~     model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and~     insulin. Also, to better understand the potential mechanism and the role circulating vitamin~     D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid~     (mRNA) expression of vitamin D receptor (VDR) and various inflammatory genes in visceral~     (VAT) and subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive~     bariatric procedure. We hypothesized that subjects with higher serum vitamin D levels would~     be less inflamed and more insulin sensitive and have increased expression of VDR and~     pro-inflammatory markers compared to those with lower serum vitamin D levels.~   "
67866|NCT02169037|"~     This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal~     Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial~     fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year~     will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal~     Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV~     isolation).~   "
67890|NCT02168725|"~     The main objectives of this study are to determine the safety profile of briciclib, an~     experimental anti-cancer drug, as it is administered intravenously once weekly as escalating~     doses in adult patients with advanced cancer and solid tumors, and to determine the highest~     dose of briciclib that can be safely given. Secondary objectives are to determine how the~     amount of briciclib in circulation changes over time and how much briciclib gets into the~     urine for excretion, and to document potential anti-tumor effects of briciclib.~   "
67867|NCT02169024|"~     This study addresses the intractable challenges of adverse birth outcomes, including preterm~     delivery and low birthweight, by proposing the development, implementation and evaluation of~     a model of group prenatal care that could be scaled nationally. Group prenatal care models~     have been demonstrated through rigorous research to provide significantly improved birth~     outcomes with implications for maternal-child health and substantial cost savings. However,~     group prenatal care is currently available to only a small fraction of the more than four~     million women who give birth annually in the US. Through the development, implementation and~     evaluation of a new model of group prenatal care, we will create an outcomes-focused model~     of group prenatal care that will be scalable nationally with an eye toward improving US~     birth outcomes.~      The long-term objective of the proposed study is to reduce the risk for adverse perinatal~     outcomes during and after pregnancy among women and families receiving prenatal care in~     health centers in 3 geographic locations serving vulnerable populations: Hidalgo County~     Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate~     a new and improved model of group prenatal care, Expect with Me, based on our previous~     research on group models of prenatal care, which has already yielded favorable behavioral~     and biological results in two randomized controlled trials.~      We hypothesize that, relative to women who receive standard individual prenatal care, the~     women who receive Expect with Me group prenatal care will be significantly more likely to:~        1. have better perinatal outcomes, including better health behaviors during pregnancy~          (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm~          labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum~          indicators (e.g., increased breastfeeding);~        2. report greater change in risk-related behaviors and psychosocial characteristics that~          could be considered potential mechanisms for the program's effectiveness;~        3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year~          postpartum;~        4. have lower healthcare costs through improved outcomes (e.g., appropriate care~          utilization, fewer complications, reduced NICU admissions/length of stays)~      Comparisons based on propensity-score matched sample of women receiving standard individual~     prenatal care at the same clinical sites.~   "
67868|NCT02169011|"~     The purpose of this study is to examine the different outcomes of breast reconstruction in~     women who are treated for breast cancer with mastectomy and subsequently have delayed breast~     reconstruction by one of two different surgical techniques both of which are based on the~     use of a tissue flap from the patient's back. These techniques are either a latissimus dorsi~     flap (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap)~      The main objective of the study is to establish whether one of these techniques may result~     in a superior outcome and thus should be recommended as first choice treatment rather than~     the other.~   "
67869|NCT02168998|"~     The purpose of this study is to determine whether the presence of a medical clown in a~     pediatric emergency department procedure room would reduce children's anxiety. The~     investigators hypothesize that this positive influence will be expressed as lower levels of~     the stress hormone (Cortisol) in the blood.~   "
67870|NCT02168985|"~     The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to~     increase household resilience by strengthening families. TFH draws on improved communication~     and conflict resolution skill building and the individual's faith-values as a catalyst for~     transformation in attitudes regarding gender roles in care giving and the use of violence in~     the home. The study hypothesis is that couples who complete the Faithful House Programme~     will demonstrate increased communication skills with their spouses and children, which~     reduces the negative impact of family stress triggers and ultimately leads to a reduction of~     intimate partner violence witnessed by children as well as physical and emotional violence~     against children by parents.~      The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected~     or conflicted couples and a child in each household, focus group discussions (FGD) of men,~     women and children and key informant interviews of local experts in family violence and~     social protection service network providers.~   "
67871|NCT02168972|"~     The purpose of this study is to provide clinical data pertaining to the safety and~     performance of the Globe® Mapping and Ablation System for treating patients with atrial~     fibrillation.~   "
67872|NCT02168959|"~     The primary purpose of the proposed study is to compare postoperative pain scores and total~     opioid consumption between two groups randomized to either receive or not receive a femoral~     nerve block for pain control following surgical repair of a tibial plateau fracture. Pain~     will be assessed post-operatively using standard numeric pain scores rated on a 0 - 10~     scale, as well as using the University new pain assessment tool - the Clinically Aligned~     Pain Assessment (CAPA). This new 5 question pain assessment tool has not yet been validated,~     but does address several key questions, including patient comfort, pain control, change in~     pain status, daily functioning, and sleep quality. Along with post-operative pain scores, we~     will compare total opioid consumption between the two groups.~      The null hypothesis is that there is no difference in pain scores or total opioid~     consumption between patients receiving a femoral nerve block and those without a nerve block~     following surgical repair of a tibial plateau fracture.~      A secondary outcome will examine long-term pain control, range of motion, and functional~     status of these patients at their regular orthopedic clinic follow-up appointments. The same~     pain scores will be assessed, along with quadriceps strength and knee range of motion.~     Patients will complete the PROMIS Physical Function CAT and short Musculoskeletal Function~     Assessment, patient reported outcomes tools to evalute physical function.~      A teriary outcome will be to retrospectively examine postoperative pain scores and total~     opioid consumption for all tibial plateau fracture patients seen at the University of Utah~     for surgical repair in the past 10 years.~   "
67873|NCT02168946|"~     Carbavance™, (meropenem/vaborbactam) is being compared to the Best Available Therapy in the~     treatment of adults with selected serious infections due to Carbapenem Resistant~     Enterobacteriaceae~   "
67874|NCT02168933|"~     Psoriasis is a common skin disease, which affects 2-3% of the population. Up to two third of~     patients with psoriasis develop nail changes. These visible changes can be painful and~     disabling and are associated with social stigma. Most topical treatments are only partially~     effective. Systemic treatments can have serious side effects. Excimer laser is a form of~     targeted ultraviolet light therapy that has been successfully used to treat isolated~     psoriatic plaques on difficult to treat areas such as scalp or palms. The purpose of this~     study is to investigate efficacy of excimer laser for treatment of fingernail psoriasis.~     Sixteen patients with stable fairly symmetric fingernail psoriasis will be enrolled. After~     obtaining informed consent, an investigator will evaluate the severity of nail psoriasis in~     each hand using an objective score, called Modified Nail Psoriasis Severity Index (mNAPSI).~     In a random fashion, one hand will be treated with excimer laser and the other hand will~     receive sham treatment. During the treatments, patients will wear protective eyewear that~     does not permit them to see which hand receives active treatment and which hand receives~     sham treatment. Patients will be treated twice a week for 8 weeks. At weeks 8, 12, and16 the~     investigator who is blinded to the treatment assignments will re-evaluate the fingernails~     using mNAPSI score. Mean change from baseline mNAPSI score at weeks 8, 12, and 16 in hands~     treated with excimer compared to hands treated with sham will be measured. We will also~     measure patient's assessment of severity of nail disease and the pain or any adverse events~     associated with laser treatments. Given the slow growth rate of fingernails, the final~     evaluations will be performed at week 16. In summary, this is the first controlled study to~     evaluate efficacy of excimer laser in fingernail psoriasis. If found to be effective,~     excimer laser could be used as a safe, locally administered treatment for recalcitrant nail~     psoriasis.~   "
67875|NCT02168920|"~     To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI]~     total score from baseline as the primary efficacy variable), dose-response, and safety of~     aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation~     associated with Alzheimer's type dementia~   "
67876|NCT02168907|"~     This phase I trial studies the side effects and best dose of CPI-613~     (6,8-bis[benzylthio]octanoic acid) when given together with bendamustine hydrochloride and~     rituximab in treating patients with B-cell non-Hodgkin lymphoma that has come back or has~     not responded to treatment. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic~     acid and bendamustine hydrochloride, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill~     them. Giving 6,8-bis(benzylthio)octanoic acid with bendamustine hydrochloride and rituximab~     may kill more cancer cells.~   "
67877|NCT02168894|"~     The goal of this clinical research study is to learn if one acupuncture treatment approach~     is more effective than another in helping to relieve neuropathy in cancer patients.~   "
67878|NCT02168881|"~     This study is to compare between oral misoprostol in solution and vaginal dinoprostone in~     induction of labour in primiparous women with singleton pregnancy as regards efficiency and~     safety to both mother and fetus.~   "
67879|NCT02168868|"~     The purpose of this study is to analyze the immunological profile in blood of children with~     ASD.~   "
67880|NCT02168855|"~     The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement~     Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent,~     smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment~     (EMA).~   "
67881|NCT02168842|"~     The purpose of the study is to determine whether treatment with isradipine is effective in~     slowing the progression of Parkinson disease disability.~   "
67882|NCT02168829|"~     This trial is comparing medical approaches for stroke prevention in people who have atrial~     fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or~     substantially reduce the arrhythmia. AF is normally associated with an increased risk of~     stroke which in many patients can be prevented with appropriate blood thinner therapy. This~     trial will compare a strategy of oral anticoagulant therapy after successful ablation to~     therapy with an aspirin per day.~   "
67883|NCT02168816|"~     The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and~     treatment of diabetic foot infections state that for the treatment of diabetic foot~     osteomyelitis No data support the superiority of any specific antibiotic agent or treatment~     strategy, route, or duration of therapy. Traditionally, osteomyelitis has been treated with~     a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high~     bioavailability and adequate bone penetration have been shown in published studies to be~     effective for the treatment of osteomyelitis.~      The investigators propose to conduct a prospective, single-center, randomized, open trial at~     Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to~     intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The~     investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic~     therapy.~      Bone/tissue cultures are obtained for all patients for clinical purposes and are sent to~     pathology for histologic examination and to the clinical microbiology laboratory for culture~     and susceptibility.~      Patients will receive six weeks of IV or oral antibiotic therapy depending upon their~     randomization group. Primary outcomes at six months clinical follow-up will include: (i) no~     evidence of bone infection and (ii) resolution of ulcer.~   "
67884|NCT02168803|"~     The main purpose of this study is to measure how much of the drug gets into the blood stream~     and how long it takes the body to get rid of it when given once a day for 12, 24, and 52~     weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream.~     Information about any side effects that may occur will also be collected.~      This study will also evaluate how the study drug reacts in the body when given once a day~     for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment~     is complete. The relationship between study drug and the results from the how the study drug~     reacts in the body may be explored, if needed.~   "
67885|NCT02168790|"~     The investigators aimed at developing a technique to apply amniotic membrane to a diseased~     ocular surface without surgical intervention (sutureless amniotic membrane transplantation).~     This system needs to be concordant with laws and guidelines for the use of medical and~     pharmaceutical products.~   "
67886|NCT02168777|"~     Phase I: Determine the maximum tolerated dose of combination of Regorafenib with~     Refamentinib through a dose escalation study, all tumor types that meet certain~     inclusion/exclusion criteria can be entered.~      After the recommended dose is determined, the Phase II portion of the study will evaluate~     tolerability and efficacy of the combination treatment in patients with breast cancer, lung~     cancer, or colorectal cancer, respectively.~   "
67887|NCT02168764|"~     The primary objective of the study is to demonstrate the safety and efficacy of SPG~     stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in~     chronic cluster headache patients.~   "
67888|NCT02168751|"~     Lung ventilation required for lung resection surgery induces a proinflammatory response~     including cytokine production and recruitment of leukocytes and macrophages in the lung~     associated with postoperative complications, mainly acute lung injury (ALI). The~     lung-protective ventilation has been shown reduce this inflammatory response and play a~     protective role against ALI, even though it is unclear the role of intravenous and~     inhalational anesthetic agents in immunomodulation of the inflammatory response during lung~     ventilation and its possible protective role against ALI. This study aims to determine the~     effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative~     stress and ischemia-reperfusion, and assess the relationship between these mediators and~     postoperative morbidity defined as percentage of postoperative lung complications (ALI /~     ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30~     days. The investigators hypothesis, based on results of our group in animal research, is~     that inhalants cause a lower proinflammatory response to intravenous agents for lung~     resection surgery.~      A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung~     protective ventilation, in which the markers will be measured before and after one-lung~     ventilation in both lungs and in plasma before, during and after one-lung ventilation.~     postoperative lung complications, ICU and hospital stay and 30 days mortality.~   "
67891|NCT02168712|"~     Exercise therapy increase functional capacity improving the morbidity and mortality of~     patients with cardiovascular disease. Moderate continuous training is the best established~     training modality for this patients. However, a body of evidence has begun to emerge~     demonstrating that high intensity interval training obtained better results in terms of~     morbidity and mortality.~      The purpose of this randomized clinical trial was to determine the effect of two types of~     exercise training: moderate continuous training vs high interval training on functional~     capacity and quality of life as well as verify the safety in its application.~      We included 72 patients with coronary artery disease by assigning one of the training~     modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of~     life as well as a record of adverse events.~   "
67892|NCT02168699|"~     Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete~     anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve~     is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while~     there is limited information regarding ultrasound imaging of the musculocutaneous nerve in~     children.~      The aim of this prospective imaging study is to investigate whether musculocutaneous nerve~     is visualized in childhood with the use of ultrasound imaging or not. A secondary aim of~     this study is to assess the percentage of its visualization according to the age.~      Parental written informed consent is obtained from all participants. The children are~     divided into three groups according to their age: Group 1, with infants aged less than 12~     months; Group 2, with toddlers and preschoolers; and Group 3, with school-aged children~     (6.5-12 years).~      Children are placed in the supine position with the involved arm abducted at 90° and the~     elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the~     axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is~     searched near the axillary artery (proximally) and its course is followed distally (into the~     coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both~     proximally and distally.~   "
67893|NCT02168686|"~     The purpose of this study is to test the safety and primary efficacy of a gene transfer~     vector (drug) for the treatment of alpha1-antitrypsin (A1AT) deficiency. The study uses an~     experimental drug (ADVM-043 also known as AAVrh.10halpha1AT) to deliver a gene (gene~     transfer) to treat the signs and symptoms of A1AT deficiency. Unlike other drugs, this one~     is made of a virus called adeno-associated virus (AAV). In this study, the AAV acts as the~     vehicle used to carry the A1AT gene into the lung cells so it can treat the cells.~   "
67894|NCT02168673|"~     Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary~     disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their~     airways. Even smokers who have not developed COPD may have difficulty clearing the airways.~     This is partly because smoking impairs the function of cilia, tiny hairs lining the airways~     that sweep out mucus to keep the airways clean. The investigators have found that smoking~     reduces the length of cilia, which may contribute to the worsened cilia function in smoking~     and COPD. This is true even in smokers who show no signs of lung disease. The investigators~     believe that smoking affects levels of genes in lung cells, resulting in shorter cilia.~   "
67895|NCT02168660|"~     Vitamin D deficiency is extremely common in obese youth. In our obese population followed in~     the Endocrinology clinic at CMC, vitamin D levels were inversely correlated with a measure~     of insulin resistance. We propose to show that correction of vitamin D levels in obese~     children and adolescents improves their insulin sensitivity. Obese youth presenting to the~     Center for Obesity and its Consequences on Health (COACH) clinic will be randomized to~     receive either the most recent Institute of Medicine (IOM) recommendations of minimum D3~     dose of 600 IU/day (1), or receive higher doses of D3 such that the blood levels of vitamin~     D will be brought to a target level in either the low part or high part of the normal range.~     The goal is to determine if correction of vitamin D deficiency will improve insulin~     sensitivity in this group. Secondary goals include determining whether correction of vitamin~     D deficiency in obese adolescents and children results in less weight gain, and determining~     the amount of D3 required to correct vitamin D levels in this population.~      Our specific hypotheses are as follows:~      Hypothesis #1 Obese youth treated with Vitamin D3 who achieve low-normal 25-OHD levels~     (30-50 ng/mL) or high-normal 25-OHD levels (60-80 ng/mL) will have improved insulin~     resistance, as measured by HOMA-IR, compared to those individuals with deficient 25-OHD~     levels (< 30 ng/mL).~      Hypothesis #2 Subjects with a higher BMI will have higher Vitamin D dose requirements than~     current IOM recommendations of 600 IU/day and will take a longer period of time to reach~     target 25-OHD levels.~      Hypothesis #3 Subjects with normal 25-OHD levels will demonstrate less weight gain compared~     to subjects on the control arm.~   "
67896|NCT02168647|"~     Multiple studies have demonstrated a very low prevalence of women meeting physical activity~     and weight gain recommendations during pregnancy. The aim of this study is to provide a~     lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent~     excessive gestational weight gain, decrease postpartum weight retention, and improve mental~     well-being compared to usual care using a randomized controlled design in pregnant women.~     Participants in the intervention group will receive behavioral lifestyle counseling and take~     part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week~     14 of their pregnancy to child birth. Participants in the usual care group (control) will~     not receive any lifestyle counseling. Data collected from this group will be used to compare~     the effectiveness of the lifestyle intervention. Unlike many studies examining diet and~     physical activity factors alone, this study evaluates additional psychosocial factors such~     as psychological health, self-efficacy, competence, motivation and barriers that may~     influence excessive gestational weight gain. In addition, the Self-Determination Theory~     framework will be used to measure how motivation and motivational interviewing strategies~     can help explain changes in volitional behavior.~   "
67910|NCT02168465|"~     1. Design and develop web-based self-management intervention to improve catheter-related~          outcomes and quality of life in people with spinal cord injury (SCI).~        2. Conduct a pilot study to assess the feasibility (i.e., acceptability and usability of~          the website application) and preliminary effectiveness of this new self-management~          intervention.~        3. Develop and test the reliability of new/modified measures (intermittent catheter~          self-efficacy and self-management).~   "
67897|NCT02168634|"~     Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the~     population. The patients with hypertrophic scar usually seek medical assistance not just for~     the annoying appearance but mostly due to the intractable itchiness. There have been a~     variety of effective methods to alter the appearance of the scar. However, the treatments~     for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat~     histamine-induced itch with favorable results. In the clinical setting, however, the~     efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the~     goal of this study is to conduct a randomized controlled trials about using Botox to treat~     itch from hypertrophic scar.~   "
67898|NCT02168621|"~     Treatment directed towards the control of periodontal infections is to about 90%~     non-surgical procedures. There is evidence from a large number of randomized controlled~     studies that the efficacy in terms of clinical outcomes of a full-mouth ultrasonic~     debridement approach (FMUD) is comparable to that of traditional section-wise scaling and~     root planing (SRP). A hypothesis for the current effectiveness study is that comparable~     clinical effects will be obtained with the FMUD approach as with conventional section-wise~     SRP, but with significantly more favourable patient-centred and health-economic outcomes.~      This randomized study involves about 100 professionals (dental hygienists) and more than~     1000 patients at 45 dental clinics in the Vastra Gotaland Region, Sweden. The project not~     only evaluate treatment effects in terms of pertinent clinical outcomes, it also has a~     strong focus on patient-centered measures - patient-reported experience measures (PREM) and~     patient-reported outcome measures (PROM) - as well as health-economics.~   "
67899|NCT02168608|"~     Remote ischemia precondition could protect the liver from ischemia reperfusion injury in~     patients undergoing hepatectomy.~   "
67900|NCT02168595|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single~     ascending IV doses of GMI-1271 in healthy adult subjects.~   "
67901|NCT02168582|"~     This is an observational study that aims to characterize individual response of patients~     getting physical therapy for chronic non-specific low back pain.~      Participants will be classified based on a questionnaire and motor tests to investigate~     whether individual improvement after physical therapy may be predicted. These observations~     may help to decide which should be the preferred treatment offered.~   "
67902|NCT02168569|"~     This is a classical in vivo clinical trial, following World Health organization's~     recommendations, ran as a multisite study within Mozambique trying to assess the efficacy~     and safety in 5 sites of the two oral ACTS artemether-lumefantrine (AL) and~     Amodiaquine-Artesunate (AQ-AS), first and second line treatment for malaria in mozambique,~     respectively, for the treatment of uncomplicated malaria in children aged<5 years.~   "
67903|NCT02168556|"~     This is a randomized controlled trial to determine if music, a video, or standard of care~     will decrease anxiety in patients undergoing urodynamic testing.~   "
67904|NCT02168543|"~     -  Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases~          new bone formation in chronic periodontitis patients~        -  Till date no study has reported the effect of local delivery of ALN in chronic~          periodontitis patients among smokers. Hence the aim of this study is to investigate the~          clinical and radiographic effects of locally delivered ALN as an adjunct to the non~          surgical treatment in smoker chronic periodontitis patients.~   "
67905|NCT02168530|"~     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of~     vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one~     of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks.~     Study drug will be administered daily by the oral route. An 8-week safety follow-up period~     is included for all patients who receive at least one dose of study drug.~   "
67906|NCT02168517|"~     The overall aim of the study is to investigate if patients with musculoskeletal chronic pain~     have reduced semen quality in comparison with age matched healthy controls. Secondly, the~     aim is to investigate whether overweight with or without chronic pain are related to reduced~     semen quality. We will investigate semen quality in obese chronic pain patients, normal~     weight chronic pain patients and in obese and normal weight healthy controls.~   "
67907|NCT02168504|"~     A simple, painless and reliable method to detect Parkinson's disease at an early stage is~     very important to patients, doctors and researchers. Doctors want to help patients early,~     and scientists want to select patients for their research who will help in development of~     better drugs. We hope that the changes in electrical activity of hand muscles during~     handwriting will help in early detection of this disease.~   "
67908|NCT02168491|"~     Premixed insulin-based therapy is a standard insulin treatment strategy in Austria. The~     widespread use of premixed insulin is explained by high acceptance by health care~     professionals and patients due to one single product and flexible number of injections (1-3~     daily) which covers the demand in controlling fasting and postprandial glucose excursions of~     most patients with diabetes. However, the use of pre-mixed insulin frequently leads to a~     high insulin demand and consequently weight gain and an increased risk of hypoglycemia.~     Hence, achieve good metabolic control in these patients remains a major challenge.~      For those patients, the approach to treatment intensification without facing the typical~     risks of insulin treatment (hypoglycemia and weight increase) is of major importance. One,~     so far not exploited option may be the BIT-strategy: Basal insulin in combination with~     incretin-based therapy.~      Pathophysiologically basal insulin inhibits glucose production in the liver, decreases~     hepatic insulin resistance and improves the function of beta cells in the postprandial state~     by discharge of fasting insulin secretion. During further diabetes progression steadily~     increasing HbA1c levels - despite good fasting blood glucose control - indicate the need for~     additional intervention of meal-related glucose excursions. In this stage of type-2 diabetes~     basal insulin can be combined with prandial (short-acting) insulin or prandial GLP-1~     receptor agonists. However, regarding important safety parameters: risks of hypoglycemia and~     weight gain in the long-term treatment GLP-1 receptor agonists are beneficial.~      Lixisenatide is a novel GLP-1 receptor agonist with a pronounced postprandial (PPG) effect~     which fits with basal insulin mode of action primarily focused on fasting blood glucose~     reduction.~      Therefore 10 patients (both gender) under treatment with premixed insulin (2-3 times daily)~     and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1~     receptor agonist Lixisenatide (Lyxumia, once daily). The investigators hypothesize that~     switching from a therapy based on premixed insulin to a simple, once daily administered~     combination of basal insulin plus a GLP-1 receptor agonist in patients with type-2 diabetes~     not achieving therapeutic target (HbA1c>7%) is clinically feasable in an out patient setting~   "
67909|NCT02168478|"~     A 48 hour patch test performed in healthy volunteers to determine the presensitization~     (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),~     fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium~     Lauryl Sulfate) and a negative control (Saline).~      The primary objective of this study is to determine if any subjects exhibit an allergic~     reaction which may be indicative of a pre-existing sensitization.~   "
67911|NCT02168452|"~     This study aimed to evaluate the feasibility of dual sentinel node staining method using~     mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who~     receive neoadjuvant chemotherapy.~      Over the past few years, several studies have found using methylene blue, isosulfan blue,~     indocyanine green or radioisotope alone by detection method had several disadvantages.~      In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has~     potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive~     neoadjuvant chemotherapy.~   "
67912|NCT02168439|"~     The objective of this research study is to show superiority of intranasal dexmedetomidine to~     intranasal midazolam as anxiolysis prior to pediatric laceration repairs.~   "
67913|NCT02168426|"~     The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing~     the incidence of bowel obstruction and to evaluate the incidence of all serious adverse~     events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days~     postoperatively.~   "
67914|NCT02168413|"~     This study has two main goals :~        -  to develop the cortcial excitbality (CE) measurement methodology using coupling between~          transcranial magnetic stimulation (TMS) and physiological recordings such as~          electroencephalography (EEG) and electromyography (EMG),~        -  to automatize these measurements using robotized TMS.~      Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or~     clinical research. It is an important indicator which determine the stimulation power~     applied on the cortical target during the TMS experiment, or during the rTMS cure~     (patients). CE is in general measured on the motor cortex using EMG activity as the main~     indicator of the system's response, whatever the real cortical target is located. The~     present study thus propose to generalize this measurement on other cortical areas in link~     with the actual targets, and using other external recordings such as EEG. Moreover, as~     neuronavigation systems significantly improved TMS precision in the past years, CE~     measurements could significantly gain to become fully automatized using robotized TMS.~   "
67915|NCT02168400|"~     Long-term abstinence from alcohol is supported by a compensatory mechanism in functional~     brain connectivity, a potential brain biomarker that could be an intervention target. These~     findings provide a compelling case to explore whether this brain biomarker can be modulated~     to enhance patients' ability to remain abstinent. There is a need to investigate methods~     that can be used to increase functional brain connectivity. The overall objective of this~     proposal is to enhance brain functional connectivity in short-term abstinent alcoholics as a~     therapeutic intervention that supports abstinence.~   "
67916|NCT02168387|"~     The purpose of this study is to evaluate whether a therapy that uses a machine called a~     continuous high frequency oscillator (CHFO) is more successful at removing mucus than~     medications that thin out the mucus.~   "
67917|NCT02168374|"~     This study assessed the clinical performance of a resin-modified glass ionomer cement~     containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.~   "
67918|NCT02168361|"~     Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis~     comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label~     combination of simeprevir+ sofosbuvir without Ribavirin.~   "
67919|NCT02168348|"~     The investigators set out to determine whether malnutrition delayed healing of foot lesions~     in diabetic patients.~   "
67920|NCT02168335|"~     Gingivitis is defined as inflammation of the gingiva. It is a common disease that is~     prevalent in both children and adults, and in both genders . The primary cause of gingivitis~     is plaque accumulation due to poor oral hygiene; however, gingivitis may result from many~     varied aetiological factors. Gingivitis is characterized by red, swollen, spongy gums that~     bleed easily . Current conventional treatment of gingivitis involves removal of plaque and~     the use of an antimicrobial mouthwash. Mouthwashes containing chlorhexidine gluconate are~     most commonly prescribed, however these have certain adverse effects. Ora-saltsTM is a~     commercially available mouthwash composed of natural sea salt, Arnica montana 30 centesimal~     (C), Echinacea angustifolia 30C, Staphisagria 30C, Phosphorus 30C, Hepar sulph 30C, cinnamon~     and liquorice. To date there is no research on the use of OrasaltsTM in the treatment of~     gingivitis. The aim of this study is to determine the efficacy of OrasaltsTM in the~     treatment of gingivitis using the Modified Gingival Index (MGI) and the Quantitative~     Gingival Bleeding Index (QGBI).~   "
67921|NCT02168322|"~     Membrane modifecation:~      Guided tissue membrane perforations may serve as a more biologic scaffold that could allow~     for the free passage of biologic mediators from the periosteum and overlying gingival~     connective tissue into the periodontal defects.~      Study hyposethis:~      To test this hyposthesis, this study was designed to evaluate levels of vascular endothelial~     cell growth factors and platlet derived growth factors in gingival crevicular fluid (GCF)~     during the early stages of healing for localized intrabony defects treated with modified~     perforated membranes (MPMs), occlusive membranes (OMs) as compared to open flap debridement~     control (OFD).~      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this~     prospective, randomized and single blinded trial. Each patient contributed one interproximal~     defect that was randomly assigned to experimental modified perforated membrane group (10~     sites), occlusive membrane group (10 sites) or open flap debridement control (10 sites).~     Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the~     intrabony depth of the defect (IBD) were measured at baseline for patients enrollment.~     Gingival crevicular fluid (GCF) samples were collected on day 1 and 3, 7, 14, 21, and 30~     days after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels~     for sites treated by MPMs or OM compared to that of the OFD treated cases.~   "
67922|NCT02168309|"~     This study's aim is to determine whether oral extended release nifedipine is superior to~     oral labetolol for the management of postpartum severe hypertension, specifically time to~     achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral~     extended release nifedipine is superior to oral labetolol for achieving goal blood pressure~     in the postpartum period.~   "
67923|NCT02168296|"~     The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two~     different matrices, at different dose levels.~   "
68984|NCT02154399|"~     This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen,~     hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in~     measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.~   "
67924|NCT02168283|"~     INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease~     patients. However, cardiovascular disease remains the major cause of morbidity and mortality~     in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is~     an important cause of cardiovascular disease in PD patients.~      OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood~     pressure, hospitalization and cardiovascular morbidity in PD patients.~      HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could~     improve the clinical outcome of PD patients.~      DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to~     recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2~     liters. Patients will be randomized to active fluid management (treatment arm) or~     conventional management (control arm).~      STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.~      INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling,~     diuretics, and intensive dialysis regimen. For the control arm, patients will only receive~     dietary counseling. Patients will be followed for one year.~      MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of~     hospitalization for all cause, and hospitalization for cardiovascular disease during the~     study period.~      DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization~     data will be compared by non-parametric Mann Whitney U test.~      EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid~     overload in PD patients.~   "
67925|NCT02168270|"~     This phase I trial studies the side effects and best dose of ascorbic acid when given~     together with temozolomide in treating patients with high-grade glioma that has come back.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Ascorbic acid contains ingredients that may prevent or slow the growth~     of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.~   "
67926|NCT02168257|"~     The purpose of this study is to determine if the RAM cannula is as effective as conventional~     binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.~   "
67927|NCT02168244|"~     Injectable biologic drugs are used as a treatment of psoriasis. These injections can~     sometimes be associated with pain. In this study the investigators aim to reduce the pain by~     applying heat or ice to the skin 2-3 minutes before injecting the drug, and to compare the~     pain to injection without any heat or ice.~   "
67928|NCT02168231|"~     Incisional hernia is the most frequently seen long term complication in surgery causing much~     morbidity and even mortality in patients. Despite studies on the optimal closing technique~     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%.~     It has been established that implementing a mesh reduces recurrence of the incisional hernia~     but still the results of repair are often disappointing. Incisional hernias can become~     increasingly complex due to complicated abdominal wall defects caused by a disturbed~     anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save~     to repair the incisional hernia by means of a synthetic mesh and other augmentation tools~     need to be implemented.~      In the recent years the use of biological meshes has been gaining popularity. Recent reports~     of the use of collagen-based prosthesis have suggested that they support new vessel growth,~     do not excite a significant foreign body reaction, form fewer adhesions, are well~     incorporated into host tissues with minimal wound contraction, and can be used in grossly~     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a~     source tissue and processed for medical use but they vary widely in their processing~     methods. They include tissues of human or animal origins, both chemically cross-linked and~     non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current~     studies investigating the effectiveness of these meshes are small and have short periods of~     follow-up. These shortcomings can be explained to high cost of the meshes and unclear~     indication when to use a biological mesh.~      The aim of this study is to investigate the short and long term effects of the Strattice~     biological mesh. The investigators will also inquire why a biologic mesh was used and what~     the direct and indirect costs were.~   "
67929|NCT02168218|"~     This study aims at assessing the hypothesis that dietary protein content is a major factor~     regulating lean body mass gain and energy expenditure during overfeeding, and thus long term~     body weight gain~      To test this hypothesis, healthy normal weight male and female subjects will before and~     after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a~     low (5% total energy) or a high (20% total energy) protein intake. Each subject will be~     studied with both hlow- and high protein diets according to a randomized, crossover study.~     On each occasion the following measurements will be done in basal conditions (after 2-day~     isoenergetic, controled diet) and at the end of the 7-day overfeeding:~        -  whole-body protein turnover, oxidation and synthesis in fasting conditions and fed~          conditions (13C-labelled leucine)~        -  intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)~        -  Energy metabolism in fasted and fed conditions (indirect calorimetry)~        -  plasma concentration of glucose, non-esterified fatty acids, total triglyceride,~          very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone~          (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein~          (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and~          low-protein sucrose overfeeding on whole body protein synthesis will be compared using~          two-way ANOVA; relationships between changes in whole body protein synthesis on one~          hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and~          plasma concentration of metabolic variables on the other hand, will be evaluated by~          linear regression analysis~   "
67930|NCT02168205|"~     This study will evaluate the effect of food and smoking on healthy older subjects taking~     pomalidomide.~   "
67931|NCT02168192|"~     The purpose of this study is to assess the utility of training in Breaking Bad News (BBN)~     skills. We hypothesize that given little or no formal training in breaking bad news,~     obstetric providers will benefit from a curriculum of teaching breaking bad news techniques,~     but will benefit more from a simulation teaching technique than from a lecture in breaking~     bad news techniques.~      The investigators also hypothesize that providers who have undergone breaking bad news~     simulation will receive improved scores after the simulation debriefing compared to their~     pre-simulation scores, and their improvement with be greater than the control group.~   "
67932|NCT02168179|"~     This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in~     patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy,~     painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy~     may be a better treatment for radiation dermatitis.~   "
67933|NCT02168166|"~     Cognitive remediation (CR) therapies refer to a number of recent developments to use~     behavioural strategies to improve neurocognitive abilities and improve everyday functioning~     in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study,~     we aim to examine whether we can observe CR effects on measures of neuroplasticity,~     cognition, and functioning when using a rigorous control comparison group. We hypothesize~     that the active group will exhibit improvements in executive functioning composite scores,~     improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the~     placebo group.~   "
67934|NCT02168153|"~     This study is a randomized controlled trial designed to evaluate changes in reaction times~     (RTs) and response times (RespTs) following chiropractic treatment compared to controls in~     the Special Forces Qualified (SFQ) population, including Special Operation Forces who are~     part of the 160th SOAR regiment on flight status.~   "
67935|NCT02168140|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together~     with bendamustine hydrochloride in treating patients with relapsed or refractory T-cell~     non-Hodgkin lymphoma or Hodgkin lymphoma. CPI-613 may kill cancer cells by turning off their~     mitochondria, which are used by cancer cells to produce energy and are the building blocks~     needed to make more cancer cells. By shutting off mitochondria, CPI-613 may deprive the~     cancer cells of energy and other supplies needed to survive and grow. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving CPI-613 with bendamustine hydrochloride may kill more cancer~     cells.~   "
67936|NCT02168127|"~     The purpose of this six month, open-label study is to evaluate the long-term safety and~     efficacy of PRC-063 in adults and adolescents with ADHD.~   "
67937|NCT02168114|"~     The purpose of this research study is to determine the potential of Optical Imaging~     techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected~     exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms~     before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only~     undergo the imaging techniques without exercise.~   "
67938|NCT02168101|"~     The purpose of the study is to determine whether MLN9708 is effective as maintenance therapy~     following allogeneic stem cell transplant in patients with high-risk multiple myeloma.~   "
67939|NCT02168088|"~     This study seeks to incorporate genetic testing into the postmortem examination of cases of~     sudden unexplained death.~   "
67940|NCT02168075|"~     Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical~     field, especially in large size or with brain edema, it is necessary to decrease brain~     volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has~     been known to decrease ICP effectively. But there are some debates in regard to appropriate~     dose of mannitol.~   "
67941|NCT02168062|"~     Randomized, phase 2 study to assess the impact of the multi-disciplinary STAND clinic on~     changes in key metabolic parameters, quality of life, and patient satisfaction among men~     receiving androgen deprivation therapy for prostate cancer. Standard-of-care therapy will~     consist of every 3-month visits comprised of review of medical history, toxicity assessment,~     and lifestyle modification counseling provided by a dietitian and exercise physiologist on~     an as-needed basis. Men randomized to participate in the multi-disciplinary STAND clinic~     will have, in addition to every 3-month visits with an individual health care provider,~     structured and individualized exercise and dietary counseling.~      A separate non-randomized patient cohort of 20 patients who are receiving concurrent~     chemohormonal therapy will be enrolled in parallel.~      The primary hypothesis of the study is that active participation in a multi-disciplinary~     clinic, as compared to current standard-of-care, will lead to lessened impact of androgen~     deprivation therapy on metabolic parameters and improved quality of life.~   "
67942|NCT02168049|"~     The investigator goal is to test a new device to see if it can provide continuous and~     simultaneous monitoring of heart and lung function.~   "
67943|NCT02168036|"~     The purpose of this protocol is to obtain biologic materials from the mediastinal lymph~     nodes from patients with lung disease and mediastinal lymph node involvement in order to:~     (1) develop a better understanding of the cause and development of lung disorders involving~     the mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict~     the behavior of human lung diseases; and (3) identify individuals who will be suitable~     candidates for other protocols such as those involving investigational new drugs.~   "
67944|NCT02168023|"~     Surgical site infections (SSIs) constitute an important medical and socioeconomic problem~     worldwide. Despite the fact that the risk factors for SSIs were identified and the~     continuously increasing medical knowledge in the fields of tissue engineering, molecular~     biology and microbiology facilitated the development of numerous new recommendations and~     methods for management, in many cases the available options for successful treatment of~     post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs~     often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas,~     or become sites of origin for systemic infections. Patients are exposed to risk of further~     complications and hospitalization time extends resulting in increased total treatment costs.~     Treatment prolongation affects also the quality of life and psychosocial functioning of~     patients with impaired wound healing. Considering the arguments above, appropriate~     prevention and management of infected post-surgical wounds is currently one of the~     priorities for the majority of invasive medical disciplines.~      Obstetrics constitute a field of medicine in which the issues associated with wound healing~     are particularly relevant. According to the literature data wound infections occur in~     approximately 1.8-11.3% of women undergoing caesarean section.~      Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds~     microorganisms to the dressing fibres as a result of hydrophobic interaction. As the~     mechanism of DACC action is solely physical no chemical agents are released into the wound~     bed and the dressing could be safely used by women during puerperal period.~      The purpose of this randomized controlled study is to compare the effect of DACC impregnated~     dressing and standard surgical dressing in the prevention of SSIs in adult women following~     caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors~     of SSIs and analyze health economics of DACC impregnated dressings for prevention of~     post-cesarean wound infections.~   "
67967|NCT02167711|"~     The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct~     cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective~     internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with~     intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic~     cholangiocarcinoma. This study aims to study the benefits of sequential administration of~     SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic~     cholangiocarcinoma.~   "
67945|NCT02168010|"~     The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in~     patients with low back pain for 3 months after surgical treatment. It is a randomized,~     placebo-controlled, double blind, multi-center phase III clinical trial. Patients with~     chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and~     70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are~     divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with~     Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4~     measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required~     to score their pain with pain VAS and to have regular blood, urine, and renal/liver function~     tests. The changes of the pain VAS at day 21 are compared between groups.~   "
67946|NCT02167997|"~     To compare the safety and efficacy of treating small aneurysms with coils specially designed~     for small aneurysms to historically reported rates of safety and efficacy for the treatment~     of larger aneurysms.~   "
67947|NCT02167984|"~     Esophageal dysmotility due to immaturity could promote impaired bolus transit during~     esophageal swallow events,thus influencing gastroesophageal reflux (GER) clearance.~      Aim of this study was to describe esophageal bolus transit characteristics during swallow~     and to evaluate the relationship between esophageal swallow (ES) and GER in newborns with~     gastroesophageal reflux disease symptoms using multichannel intraluminal impedance.~      The simultaneous analysis of swallow and GER events in newborns undergone MII/pH monitoring~     could provide useful information to better understand the physiopathology of~     gastroesophageal reflux disease (GERD) and could help clinicians to identify newborns with~     prolonged esophageal clearance time, making the recommendations for further tests and the~     therapeutic approach more accurate~   "
67948|NCT02167971|"~     The purpose of this study is to determine whether repetitive Transcranial Magnetic~     Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse~     axonal injury(DAI) after Traumatic Brain Injury(TBI).~   "
67949|NCT02167958|"~     The purpose of this study is to determine whether stem cells collected from a donor's blood~     stream will be as safe and effective as using bone marrow collected from a donor's pelvic~     bone.~   "
67950|NCT02167945|"~     The purpose of this study is to evaluate Long-term Outcomes following treatment with~     ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C~     Virus (HCV) Infection~   "
67951|NCT02167932|"~     This study will look at whether or not participating in a physical activity intervention~     during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a~     large increase after chemotherapy.~   "
67952|NCT02167919|"~     Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with~     benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in~     decreasing the volume of the prostate gland.~      Participants: Study participants will be recruited from UNC Urology clinics as well as~     referring providers. We will include 15 men who are experiencing LUTS not controlled by~     medication with estimated prostate gland weight between 80 and 150 grams.~      Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical~     prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT~     angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will~     be scheduled at 1, 3, 6, and 12 months after the procedure.~      At the end of the follow-up period, if reduction in prostate gland size has made the patient~     eligible for transurethral therapy, they may proceed to such procedure or elect to undergo~     no further surgical procedure, depending on residual symptoms. Similarly, if insufficient~     gland size reduction has occurred, the patient may elect to pursue OP or no further~     procedure if they are no longer bothered by LUTS.~   "
67953|NCT02167906|"~     Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the~     general population, mainly due to cardiovascular diseases. OA patients without~     cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although~     the molecular mechanisms are still not well known, the structure and function of the vessel~     wall can be affected by several inflammatory and metabolic parameters during OA.These~     functional and structural changes of the arterial wall leads to arterial stiffness, measured~     by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial~     stiffness and has been shown to have predictive value for morbidity and mortality. In our~     study, we planned to compare arterial stiffness in OA patients with healthy subjects.~   "
67954|NCT02167893|"~     The purpose of this survey is designed to evaluate the efficacy and safety of long-term use~     (96 weeks) of leuprorelin acetate SR 11.25 mg injection kit (Leuplin SR 11.25 mg Injection~     Kit) in prostate cancer patients in daily medical practice.~   "
67955|NCT02167867|"~     The purpose of this study is to test the ability of the lay end user to understand the~     information contained in the User's Guide; to correctly identify patients who are suitably~     qualified to receive treatment; and to correctly administer the treatment with the Erchonia~     ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter~     setting.~   "
67956|NCT02167854|"~     This is a Phase I study. The purpose of this study is to determine what is the best dose of~     the study drug BYL719 in combination with the study drug LJM716 and traztuzumab~     (Herceptin®). The study will test the safety of the combination of these three drugs, and to~     find out the effects, good and/or bad, that these three drugs have on the patient and breast~     cancer.~   "
67978|NCT02167568|"~     Corpus callosum agenesis or dysgenesis (CCA) is a major brain malformation (˜1/4000 births)~     presently diagnosed by prenatal ultrasonography. In about half of the cases, CCA is~     associated with other anomalies (complex CCA), which usually leads to medical abortion.~     Syndromes including a CCA are many (hundreds), most of which are also associated with~     intellectual deficiency (ID). Several genes are involved in such complex CCA. On the other~     hand, several studies pointed to the favorable cognitive outcome of individuals/fetuses with~     an apparently isolated CCA (ICCA) during pregnancy in about 70% of cases. However, there are~     still 30% of cases with ID or developmental delay. The precise incidence and severity of~     these disorders are presently unclear. Therefore, prenatal counseling of couples facing a~     prenatal diagnosis of ICCA is still elusive.~      Our aims are to unravel the genetic causes of CCA by combining phenotypic and genetic~     analyses in a prospective cohort of patients with CCA and intellectual disability, in order~     to improve prenatal information.~   "
67957|NCT02167841|"~     Background: The incidence of breech presentation in pregnant women is 4%. The situation can~     be treated by two methods. The first is a version of the fetus from breech presentation to~     head presentation, which can be performed in several ways, such as, an action called~     EXTERNAL CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the~     second is a cesarean section. In this study we wish to investigate if the Knee-Chest~     position is as effective as the ECV action and as a result to decrease the need for ECV.~      Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the~     ECV action.~      Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.~      Methods: The investigators will conduct a randomized clinical trial study. Every pregnant~     woman in a breech presentation with a singleton between weeks 28-32 will be randomly~     assigned into one of two groups. In the first group the women will perform daily the~     Knee-Chest position between weeks 32-37. In week 37 the investigators will check via ultra~     sound if there was a successful version (if not, the woman would go to ECV) in the second~     group we will perform ECV without doing maternal Knee-Chest position before. Every woman~     will fill a questionnaire which includes gynecological history and details regarding the~     degree of persistence and performance of the activity. At the end of this process the~     investigators will analyze the results and will come to the conclusions.~      Significance: With ECV there are number of risks and complications such as fetal distress,~     placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus.~     The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest~     position is effective as the ECV action, the investigators will recommend every patient to~     persist with this position and avoid the ECV action and the risks it entails.~   "
67958|NCT02167828|"~     Prior research has documented serious health, mental health, and social-behavioral issues~     among people living with HIV (PLH) in St. Petersburg. The investigators have established~     that PLH are clustered in friendship groups with other HIV+ persons and that an intervention~     delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in~     real life reduced mental health distress more than individual counseling. Specific aims of~     the collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify~     facilitators and barriers of medical care attendance and ART adherence among PLH in St.~     Petersburg; (2) integrate these data into an intervention designed to increase HIV care~     attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that~     recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups~     to encourage mutual social support for attending medical appointments and adhering to HIV~     care; and (4) evaluate the effects of the intervention on both behavioral and biological~     measures, including viral load. These specific aims will be achieved by research carried out~     in two phases:~      In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St.~     Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent~     or not adherent to ART, and including men and women representing diverse exposure risks.~     In-depth interviews will be analyzed to identify factors associated with attending or not~     attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends~     can support one another in HIV care entry, retention, and adherence.~      In Phase II, the investigators will undertake a randomized intervention pilot study in which~     20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care~     or is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A~     7-session group intervention will be undertaken with all members of the friendship groups in~     the experimental condition to increase care and adherence-related social support,~     problem-solving, and mutual assistance for care. Baseline to 6-month followup data will~     determine whether the intervention produces greater improvement than found in the comparison~     group in care attendance and treatment adherence, improved mental health, lower substance~     use, and lower HIV viral load.~   "
67959|NCT02167815|"~     This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of~     Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance~     of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the~     inflammatory and granulating stages of the wound healing process.~   "
67960|NCT02167802|"~     Community bacterial infection remains to this day a common cause of morbidity and mortality~     in children, which preventability is a challenge for clinicians. In a previous work, the~     investigators found that 76% supported children admitted to the ICU for severe bacterial~     infection were appraised as suboptimal and significantly associated with an increased risk~     of death. In this context, the investigators seek to identify indicators of extractable data~     PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children~     with severe bacterial infection in order to combine them and use them as a score or decision~     tree that the investigators will validate data from a national prospective multicenter study~     including 512 children admitted to the ICU for severe infection. The investigators then~     propose a score associated with a risk of suboptimality care to evaluate the performance of~     the healthcare system .~   "
67961|NCT02167789|"~     This clinical investigation is a prospective, non-randomized, multi-center, pivotal~     trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic~     feature Physiological Diagnostic (PhD).~   "
67962|NCT02167776|"~     Male circumcision has been demonstrated by three randomized trials to be a highly effective~     method of HIV prevention, leading the World Health Organization to recommend its widespread~     implementation. The investigators' prior work in Tanzania has shown that the acceptability~     and uptake of male circumcision depends highly on religious beliefs. The investigators~     hypothesize that the uptake of male circumcision can be increased in villages in which male~     circumcision is offered in conjunction with church-based teaching and practice, compared~     with villages in which male circumcision is not promoted through churches.~      The investigators will conduct a community randomized trial in rural Tanzania, where the~     government is systematically providing free male circumcision via campaigns in villages in~     which rates of circumcision are low. Prior to the start of the campaign, villages will be~     randomized to receive or not to receive church-based and culturally-informed promotion of~     male circumcision. All villages will receive the standard non-church-based health education~     that accompanies male circumcision campaigns.~      The investigators will compare rates of male circumcision, both by self-report and by~     demographic data collected at the time of circumcision, among men and boys before and after~     the campaign in intervention villages with church involvement versus control villages~     without church involvement.~   "
67963|NCT02167763|"~     The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low~     Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the~     TCu380.~   "
67964|NCT02167750|"~     The primary purpose of the research is to test the short-term effects of the consumption of~     beverages containing phytochemicals and caffeine on several aspects of cognitive~     performance.~   "
67965|NCT02167737|"~     This study aims to determine if a bedside decision aid used in the ED for mechanical fall~     prevention can increase patient participation in management options that decrease their fall~     risk. Additionally, the investigators aim to determine if there are gender differences in~     patient choices in management options and accomplished goals inspired by the decision tool.~   "
67966|NCT02167724|"~     The aim of this study is to know the bucco-dental status of patients with schizophrenia in~     Côte d'Or.~      Participation in this study will last only as long as it takes to:~        -  carry out a bucco-dental examination: evaluation of dental plaque and calculus~        -  take a blood sample to assess needs in vitamin C (only for patients included at DIJON~          CHU and CHS Chartreuse)~        -  complete a 30-minute questionnaire: clinical data and answers to questions concerning~          dental hygiene and eating habits.~   "
67968|NCT02167698|"~     This study attempts to study a new ventilation mode in children with Acute respiratory~     distress syndrome (ARDS). Despite decades of research, no intervention has brought about a~     significant decrease in ARDS mortality. Moreover, most of the studies are adult-based and~     have been extrapolated to children. Airway pressure release ventilation (APRV) mode is~     hypothesized to be superior in terms of lower need for sedation, shorter duration of~     mechanical ventilation, etc. It is unique and the first worldwide randomized controlled~     trial on APRV mode in children.~      We plan to recruit a minimum of 50 children aged (1 month-12 years) in each group. The study~     is to be conducted at the Post-Graduate Institute of Medical Education and Research~     (PGIMER), Chandigarh between March 2014 to March 2016. This trial would recruit children~     with respiratory failure and early ARDS and, randomize them to receive either conventional~     ventilation or the APRV mode. Rest of the supportive care has also been protocolized so that~     both groups receive treatment as per the existing best practices in every aspect. The~     primary outcome being studied is the number of ventilator-free days. The secondary outcomes~     include length of PICU stay, hospital stay, organ-failure free days, 28 day & 3 month~     survival, biomarkers of lung injury (IL-6, IL-8, Angiopoeitin-2, soluble-ICAM-1, etc),~     functional status, Pulmonary function tests, etc. Funding request would be sent to the~     Indian Council of Medical Research, New Delhi, India.~      Assessing lung biomarkers like Interleukin-6 would assess the role of different modes of~     ventilation in acting as triggers for multi-organ dysfunction as well as for worsening lung~     injury. This pathbreaking research is likely to open up new avenues upon completion.~   "
67969|NCT02167685|"~     The prospective observational study is to establish a registry database to evaluate the~     potential impact of prior treatment with CMX001 on the long-term incidence of specific~     events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s~     well as survival rates in subjects previously enrolled in selected clinical studies of~     CMX001. Each Registry participant will be followed for a period of approximately 3 years~     from their enrollment in the Registry.~   "
67970|NCT02167672|"~     Hysterectomy (surgical removal of the uterus) is the most common major gynaecological~     operation in women in developed countries. In Queensland, 6000 women require a hysterectomy~     for irregular periods, benign tumours or pelvic pain every year. Surgical approaches to~     surgical removal of the uterus (womb) include Laparoscopic Hysterectomy (LH), Vaginal~     Hysterectomy (VH) and Abdominal Hysterectomy through an abdominal incision (AH).~      It is widely accepted that LH and VH are less invasive surgical procedures, cause less~     bleeding, surgical complications and pain and are associated with quicker recovery from~     surgery than the more invasive AH. In a clinical trial comparing LH and AH we recently~     demonstrated that LH outperforms AH with regards to cost effectiveness causing less total~     health-services cost than AH.~      Implementation of LH in Queensland could save $9.8 million every year. Despite the evidence~     for LH and VH, 2600 hysterectomies (43%) are still performed through an open, abdominal~     incision. In brief, a common but outdated operation is still performed regularly causing not~     only unnecessary pain, surgical adverse events and longer hospital stay but also increased~     healthcare costs.~      This study will assess reasons why a significant number of gynaecologists and patients~     prefer AH over LH (Barriers to the uptake of laparoscopic hysterectomy). We will survey~     specialist gynaecologists as well as patients who have had a hysterectomy for different~     health reasons. Based on the information from the survey the investigators will develop an~     intervention to increase the rate of laparoscopic hysterectomies in Queensland and pilot~     test it.~   "
67971|NCT02167659|"~     Based upon the current state of science, the investigators are proposing to conduct a~     randomized clinical trial in which participants are randomized post-surgery to either BIS or~     circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS~     group have an L-Dex change that is ≥10 units higher than the pre-surgical baseline measure,~     and when patients in the tape measurement group have a volume change in the at-risk arm that~     is between ≥ 5% and <10% above pre-surgical baselines (without similar change in non-at-risk~     arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.~   "
67972|NCT02167646|"~     Sensory coverage in the finger continues to be a challenging problem. This study reports~     sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps~     and compares the results between the dual- and single-innervated flaps.The main evaluated~     outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the~     flap, fingertip pain and joint motion.~   "
67973|NCT02167633|"~     To determine whether stereotactic radiosurgery of metastatic spinal cord compression is~     equivalent to decompressive surgery followed by external body radiation therapy to maintain~     ability to walk at 6 weeks.~   "
67974|NCT02167620|"~     Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular~     disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk~     through associated metabolic side-effects. Risk factors for early CV mortality, including~     diabetes, are thought to occur early in the illness. Metformin, a medication used to treat~     prediabetes, and diabetes in the general population, holds promise with regard to reduction~     of antipsychotic-related metabolic problems, but has not been directly tested in early~     episode patients beyond weight loss, nor specifically in patients with diabetes or~     prediabetes and psychosis. We propose to replicate findings that metformin can reduce weight~     gain, and dysglycemia uniquely focusing on an early episode population diagnosed with~     prediabetes or diabetes. To help determine long-term risk/benefit of adjunctive metformin,~     we propose to look at changes in abdominal and liver fat, two well-established risk factors~     for CVD.~   "
67975|NCT02167607|"~     Primary objective is to determine the bioavailability of and characterize the kinetic~     profile of target polyphenol metabolites of potatoes over 6 hour postprandial period.~      Secondary objective is to assess the influence of potatoes' bioavailability and kinetic~     profiles on markers of chronic diseases.~   "
67976|NCT02167594|"~     This study will evaluate 18F-AV-1451 for brain imaging of tau in subjects with progressive~     supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.~   "
67977|NCT02167581|"~     Systematically compare the phenotype and genotype of epithelial odontogenic tumors in~     children and adults with a clinical, radiographic, pathologic and molecular level.~      Either:~      establish an observatory of this multidisciplinary tumor establish a tumor bank annotated~     scale unparalleled testing pathophysiological hypotheses search for prognostic factors.~   "
67980|NCT02167542|"~     It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV)~     to assist spontaneous breathing through a face mask during fiberoptic bronchoscopy (FOB)~     with bronchoalveolar lavage (BAL) in severely hypoxemic, nonintubated patients. With NPPV,~     FOB was well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided~     the need for endotracheal intubation. Two randomized studies have provided supporting~     evidence that the application of NPPV or CPAP via a face mask was superior to oxygen~     supplementation alone during FOB.~      For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 <~     60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon)~     delivered through a face mask.~   "
67981|NCT02167529|"~     The purpose of this study is to evaluate the evolution of quality of life and voice function~     with different questionnaires (VIH, SF36) before and after total thyroidectomy.~   "
67982|NCT02167516|"~     Complementary and alternative medicine has been employed over thousands of years to relieve~     knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been~     used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects~     may explored its mechanism. However, presently, there is a lack of large-sample,~     multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule~     treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled,~     double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule~     in the treatment of KOA.~   "
67983|NCT02167503|"~     The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome~     on patients with chronic hepatitis B.~   "
67984|NCT02167490|"~     The hypothesis of this trial are that:~        -  avoiding axillary surgery does not worsen the outcome of patients with small breast~          cancer the absence of the pathological information on the risk of recurrence given by~          nodal status is not worsening outcome of these patients~        -  pre-operative imaging of the axilla can identify patients with clinically relevant~          nodal burden.~      The aims of this prospective randomized study are:~        -  to verify whether, in presence of a negative preoperative axillary assessment, SLN can~          be spared~        -  to verify whether, in presence of a negative preoperative axillary assessment, the~          decision on adjuvant medical treatment can be taken according only to the biology of~          the tumour without the prognostic information achieved by SLNB on the nodal status~        -  to verify whether, in presence of a negative preoperative axillary assessment, the~          patients' quality of life can be improved by a less invasive surgical procedure.~   "
67985|NCT02167477|"~     An anaesthetist inserts a laryngoscope into the mouth to see the voice-box (larynx) for~     tracheal intubation, when a tube is advanced into the windpipe (trachea) to protect the~     airway and administer anaesthetic gases.~      This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz~     C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel~     photographic overlay technique to analyse the basis for any differences.~   "
67986|NCT02167464|"~     Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South~     Carolina. The investigators will assess 4 efficacious approaches to controlling~     treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension~     Specialist, Renin Treatment-Guided Therapeutics, and combination of Hypertension Specialist~     and Renin Treatment-Guided Therapeutics. Patients with TRH are evaluated with the BpTRU~     device for an accurate and representative blood pressure measure on two occasions before~     entry into the study. Qualitative data from focus group discussions with practice staff, and~     patient surveys and interviews will provide contextual data to help explain why some~     interventions are more acceptable and successful than others.~   "
67987|NCT02167451|"~     The purpose is to determine if the addition of Maraviroc to a standard transplant regimen~     will reduce the incidence of graft versus host disease in children and young adults after a~     stem cell transplant.~   "
67988|NCT02167438|"~     This study is being conducted to evaluate an FDA approved device called the HEM-AVERT®~     Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the~     second stage of labor times.~   "
67989|NCT02167425|"~     To improve ART initiation among people who inject drugs, the investigators propose to~     develop and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy~     (IMAT) in Dar es Salaam, Tanzania. In doing so, the investigators anticipate building a~     functional model of methadone and ART integration that improves the effectiveness and~     efficiency of service delivery.~   "
67990|NCT02167412|"~     Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve~     with recumbency. Few studies have evaluated orthostatic intolerance symptoms by~     electroencephalography (EEG), and none of those studies have focused on the adolescent-aged~     patient. This study will compare EEG characteristics and sweat rate during head-upright tilt~     (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with~     syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and~     lower extremity compression. The primary aim of this study is to characterize video EEG~     changes that correspond with orthostatic intolerance in youth during HUT testing. The~     investigators hypothesize that the clinical encephalopathy related to POTS and referred to~     as 'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG~     comparisons of POTS symptoms with and without abdominal and lower extremity compression~     during HUT, (2) correlation between sweat rate and EEG changes during HUT, and (3) analysis~     of EEG characteristics that distinguish syncope with POTS from syncope without POTS. The~     investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to~     syncope patients without POTS) which are protective of syncope during daily activities.~   "
68000|NCT02167269|"~     The investigators invented the baby enclosed afferent reservoir anesthesia circuit (Baby~     EAR) which could be used safely in children between 5 and 20 kg, using a fresh gas flow of~     2.5 and 3 L/min in the spontaneous breathing and controlled breathing, respectively. There~     has as yet been no study comparing the minimal fresh gas flow between the Baby EAR and~     Jackson-Rees anesthesia circuit (JR).~   "
68022|NCT02166983|"~     This randomized clinical trial studies cognitive enhancement program in improving cognitive~     function in breast cancer survivors. A cognitive enhancement program may help improve~     cognitive function in breast cancer survivors and may help doctors plan better treatment for~     cognitive decline.~   "
67991|NCT02167399|"~     Evidence supports the use of two dimensional video analysis to assess the presence of~     dynamic knee valgus during generally used screening tasks, however there is limited evidence~     to support the use of the various smart phone applications as a time and money saving option~     for clinic use . Subjects that present to the clinic and display dynamic valgus at the knee~     during the lateral step down test will be given the option to participate in the study. If~     they consent to the study they will be evaluated with 2-Dimensional video analysis to~     determine the amount of valgus present at the knee during the lateral step down test. The~     subject will also have the smart phone attached to their lower leg and the amount of valgus~     will be concurrently measured by the selected application. The primary objective of this~     study is to determine the validity of an application on the smart phone to provide an~     objective measure of dynamic knee valgus. The secondary objective of this study is to~     determine the possibility of the use of the application as a source of feedback during~     neuromuscular re-education training in order to decrease or eliminate a subject's dynamic~     valgus collapse and subsequently decreased their risk for future injury.~   "
67992|NCT02167386|"~     Black men who have sex with men (MSM) have among the highest rates of new HIV infections of~     any group in the United States. Developing effective HIV prevention interventions that work~     with this group is a critical element of the National HIV/AIDS Strategy. In the first phase~     of our study (the ethnographic phase), the investigators will carry out community-based~     research that will explore structural, social and cultural factors relevant to how Black MSM~     might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research~     will inform the design of an enhanced PrEP adherence intervention, which will be~     subsequently tested at a community-based health clinic in Harlem in the second phase of the~     project.~   "
67993|NCT02167373|"~     The purpose of this study is to determine whether the use of a mobile sensing platform in a~     primary care setting has an effect on provider workflows, patient outcomes, patient~     engagement, patient self-help behavior, health research, and total cost of care.~   "
67994|NCT02167360|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following~     sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary~     Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary~     follow-up is 1 year from cell infusion. Safety will be assessed until the end of the~     treatment and primary follow-up phase.~   "
67995|NCT02167347|"~     Aim:~      To assess the feasibility of culturally adapted Family Intervention for Psychosis.~      Design:~      Randomized Control Trial~      Setting:~      psychiatric department of different hospitals~      Participants:~      A total of 36 caregivers of Psychosis patients will be randomized to psychological~     Intervention and treatment as usual arm.~      Intervention:~      Culturally Adapted Family Intervention for Psychosis~      Outcome measure:~      Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care~     Well-Being & Support(CWS)~   "
67996|NCT02167334|"~     the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure~     Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during~     panendoscopy compared to spontaneous breathing preoxygenation.~      the hypothesis is PPV extends the residual functional capacity of lung so it provides more~     oxygen during apnea.~   "
67997|NCT02167321|"~     The introduction of total mesorectal excision (TME) and the progress of neoadjuvant~     chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced~     rectal cancer. However, systemic recurrence rate is not being improved and that is~     considered as the cause of unsatisfactory overall survival of patients with rectal cancer.~     Relatively higher systemic relapse rate than local recurrence rate is probably due to the~     insufficient control of systemic micrometastasis during adjuvant chemotherapy. The efficacy~     of adjuvant combination cytotoxic chemotherapy after surgery in treatment of rectal cancer~     remains controversial. In addition, preoperative radiotherapy increases surgical~     complication such as anastomosis site leakage and radiotherapy itself worsen sexual and~     urinary function and bowel habit which result in aggravation of the quality of life.~     Furthermore the preoperative chemoradiotherapy upto 3 months not only extends treatment~     period but increases cost of care. To reduce the possibility of overtreatment, it is needed~     to confirm that the preoperative chemoradiotherapy is absolutely necessary to locally~     advanced rectal cancer patients with safe circumferential margin (CRM) resected curatively~     by standardized TME operation.~      In this study, investigators aim to evaluate the efficacy of adjuvant FOLFOX chemotherapy~     after TME without preoperative chemoradiotherapy in patients with locally advanced rectal~     cancer having spared CRM are not inferior to that of current standard treatment.~   "
67998|NCT02167308|"~     Background: Obesity-related diseases have a profound economic impact on health care systems.~     Laser acupuncture has been shown to have beneficial effects on obesity. However, to our~     knowledge, those trials were either non-randomized, non-blinded, or included low-calorie~     diet control. Investigators have therefore designed a patient-assessor-blinded, randomized,~     sham-controlled crossover trial to investigate the significance of laser acupuncture on~     obesity.~      Methods/design: One hundred and four subjects above 20 years of age with a body mass index~     (BMI) of over 25 kg/m2 will be divided into two groups: experimental and control. Each~     subject will receive the treatment relevant to their group three times a week for eight~     weeks. After eight weeks of treatment the subject will enter a two week washout period,~     after which the subjects will switch groups. Measurements will include BMI, body fat~     percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold~     thickness, thigh circumference, body fat, blood pressure, heart rate, hunger, and the~     36-item short-form health survey (SF-36).~      Discussion: The results of this pilot study will provide the basis for future large-scale~     multicenter trials investigating the effects of laser acupuncture on obesity.~   "
67999|NCT02167295|"~     Cancer of the oral cavity is one of the fastest growing cancers among men in Taiwan.~     Previous research has established a strong link between betel quid chewing, a common~     practice among Taiwanese men, and oral cancer. However, despite the strong association, no~     attempt has been made to develop behavioral measures to facilitate betel quid cessation.~     This application extends upon existing collaboration between MD Anderson and China Medical~     University Hospital (CMUH) and seeks to characterize betel quid chewers and their withdrawal~     symptoms, in order to address an urgent cancer epidemiology issue in Taiwan.~   "
68001|NCT02167256|"~     AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment~     for malignancies because these kinases play a role in tumor invasion and proliferation.~     However, the Src family kinases (SFKs) are highly expressed in brain and have major effects~     on synaptic plasticity2. Moreover, the investigators have recently shown that a specific~     SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß)~     peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in~     preclinical models. This clinical trial will test the potential benefit of AZD0530 for~     Alzheimer's disease modification.~   "
68002|NCT02167243|"~     The purpose of this project is to evaluate the efficacy of a behavioral economic~     intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young~     adults with T1D. The intervention will reinforce patients for conducting SMBG, with~     escalating reinforcers provided when patients achieved sustained periods of testing at least~     4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients~     will be randomized to: (1) standard care or (2) standard care plus the reinforcement~     intervention.~   "
68003|NCT02167230|"~     This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to~     jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary~     intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial~     infarction, as well as 1-year major adverse cardiovascular events(MACEs).~   "
68004|NCT02167217|"~     While it has been known for many years that corticosteroid use benefits boys with Duchenne~     Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4~     years of age. The primary reason for the delay is that daily corticosteroid use has many~     side effects including short stature, obesity, and osteoporosis. A recent randomized blinded~     study of weekend oral corticosteroid use over one year showed equal improvement in strength~     with fewer side effects, particularly as related to growth and cushingoid changes. The~     investigators will test the efficacy of oral weekend corticosteroid use in infants and young~     boys with DMD who are under age 30 months. The investigators have demonstrated that the~     Bayley-III Scales of Infant development shows that infants and young boys in this age group~     who are untreated decline in abilities when compared to their peers. Here, in this Phase 2~     historically controlled trial, the investigators will use these two measures and treat boys~     at five Muscular Dystrophy Association-DMD centers~   "
68005|NCT02167204|"~     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission~     tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with~     brain tumors. Comparing results of diagnostic procedures done before, during, and after~     treatment may help doctors measure tumor growth and plan the best treatment.~   "
68006|NCT02167191|"~     It is widely known that exercise improves general fitness and that fitter patients recover~     more easily from illness and surgery. Conversely, unfit patients have a significantly higher~     morbidity and mortality after surgery and a longer inpatient stay. This will become~     increasingly important in an aging population as baseline fitness generally declines with~     age.~      One method of improving cardiovascular fitness is by using low intensity endurance training~     programmes, a disadvantage of these it that they can take several months to show~     improvement. High intensity interval training (HIT) programmes that use short episodes of~     high intensity exercise have also been shown to improve fitness. These HIT programmes have~     also shown improvement in functional capacity and quality of life in patients with chronic~     disease. An advantage of HIT is that improvements in fitness may occur in a shorter time~     than traditional endurance training. It is also known that HIT can give superior gains over~     endurance training.~      The primary aim of this study is to determine whether an improvement in aerobic fitness, as~     judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT~     programme, in a group of healthy elderly volunteers.~      As a secondary aim we will assess whether this programme would be acceptable to the group~     studied, through determination of subject compliance and adherence to the training~     programme.~   "
68007|NCT02167178|"~     Although major surgery is often required to treat abdominal problems, there is a significant~     risk of death or complication following these operations. By using ultrasound the amount and~     timing of fluid patients receive during operations can be optimised and the risk of surgery~     reduced. However, little is known about the exact changes in blood flow in the small vessels~     of the body in response to fluid. A greater understanding of this may allow for more~     appropriate care of patients undergoing this type of surgery in the future.~      In this study of healthy volunteers we will attempt to better understand how fluid~     administration guided by ultrasound effects blood flow in large and small vessels, by using~     two different techniques of ultrasound imaging. A narrow bore (approximately 4-5mm diameter)~     ultrasound probe will be passed through the nostril and mouth to rest within the oesophagus~     allowing measurement of blood flow in the main artery, while a second probe will be rested~     on the volunteer's abdomen and used to record changes in blood flow in small liver blood~     vessels. Comparison of these two techniques during the administration of fluid will allow us~     to better understand the relationship between large and small vessel blood flow.~      Because different types of fluid may behave in different ways, we will test the effect of~     two types of fluid commonly used in clinical practice; `normal` saline solution and~     gelofusine.~   "
68008|NCT02167165|"~     This study tested the hypothesis that response to digoxin is modulated by single Nucleotid~     Polymorphism (SNP):~        -  Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion~          transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the~          response to treatement.~        -  Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha~          subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to~          digoxin.~   "
68009|NCT02167152|"~     The purpose of this study is to learn about the impact of ischemic preconditioning in~     reducing contrast induced kidney damage in people with pre-existing kidney problems who are~     undergoing cardiac catheterization procedures.~   "
68010|NCT02167139|"~     This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to~     Humira® in subjects with moderate to severe RA despite MTX therapy.~   "
75935|NCT02063386|"~     To assess the absorption, distribution, metabolism and excretion of a single dose of 14C~     labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if~     formed, metabolites.~   "
68011|NCT02167126|"~     Kinesio Taping (KT) is used often, but there is little scientific information on its effect.~     The aim of this study was to evaluate the effects of KT on knee extension force among soccer~     players. KT (K-Tape®) and Micropore (3M®) were applied on the right and left thighs of 34~     professional soccer players (20 males and 14 females). Half of the participants had KT~     applied to the left and half to the right thigh. The subjects performed two maximal~     isometric voluntary contractions of the quadriceps pre, immediately post, and 24 hours after~     tape application. Isometric knee extension force was measured using a load cell and the~     following variables were assessed: peak force, time to peak force, rate of force development~     until peak force, time to peak rate of force development and 200 ms pulse. There were no~     statistically significant differences between KT and Micropore conditions or among testing~     sections (pre, post, and 24h after). Therefore, taping (independently of the type of tape~     used or time since application) did not affect the force-related measures assessed during~     maximal isometric voluntary knee extension trials performed by healthy professional~     athletes.~   "
68012|NCT02167113|"~     This non-interventional clinical study will be conducted to prospectively collect serial~     plasma samples from subjects with chronic HBV infection who are initiating antiviral~     therapy. These samples will be used to estimate clinical utility endpoints for the Aptima~     HBV Quant assay, which is used as an aid in the management of HBV-infected patients~     undergoing HBV antiviral therapy.~   "
68013|NCT02167100|"~     The purpose of this study is to determine linkage and retention in care in patients with HIV~     infection and reasons for loss to follow up Care in a High HIV-caseload Inner City Primary~     Care Practice in Sydney, Australia.~      The investigators hypothesise that patients attending HHMP will have higher rates of linkage~     and retention in care than the US HIV-infected population, and equivalent to Australian~     modelling.~   "
68014|NCT02167087|"~     This study is a clinical feasibility trial that will contribute to the clarification of~     whether sentinel node mapping with indocyanine green (ICG) provides a better basis for~     staging of colorectal cancer.~   "
68015|NCT02167074|"~     The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue~     acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G~     Echotip ProCore Fine Needle Biopsy (FNB) device.~   "
68016|NCT02167061|"~     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of~     DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in~     healthy male volunteers~   "
68017|NCT02167048|"~     This double-blind crossover study aims to compare cognitive performance (e.g., working~     memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed~     with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20~     mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants,~     vs. b) a lower-dose of psychostimulants (half of their current dose).~      The investigators hypothesize that the lower-dose psychostimulants will result in better~     cognitive performance than moderate-to-high doses of psychostimulants.~   "
68018|NCT02167035|"~     To compare Combigan BID vs Simbrinza TID in subjects currently being treated with~     Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are~     currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or~     Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment,~     if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to~     assess the tolerability of each drug.~   "
68019|NCT02167022|"~     Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain~     when the brain is most rapidly developing and which results in some motor dysfunction.~     Causes for the injury to the brain are numerous and can occur prior to birth, during the~     birth process, or within the first few months following birth. The motor dysfunction can~     involve any or all four extremities but most often affects the legs, causing abnormal~     ambulation. The level of severity depends on the extent of the injury to the brain and can~     be mild to severe. In severe instances, the child is dependent on others for all his/her~     care.~      There is no known cure for CP, but physical and occupational therapies are administered in~     an attempt to improve function. The frequency of these therapies varies from once a week~     (the standard of care in the Western Hemisphere) to five times a week (the standard of care~     in Asia and some Eastern European countries). The current understanding of brain plasticity~     offers a theoretical explanation to justify the more intense approach. Active repetitive~     motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore~     some function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons~     and prevent their 'natural' degeneration in order for them to substitute for the function of~     injured neurons. It is the very young brain that is most likely to respond to this therapy.~      The aim of this proposal is to evaluate the effect of administering both physical and~     occupational therapy five times each week for 12 weeks and compare it with the standard of~     care (SOC) approach of one time each week in children between the ages of 12 months and 36~     months. This is the first randomized crossover trial to both enroll this young a population~     of children with cerebral palsy as well as to evaluate this approach from both the~     therapists and the parents perspectives. The number of children that this study will enroll~     is larger than in most CP studies. The children will be evaluated clinically with two~     validated instruments, one of which was designed specifically for children with CP and is~     administered and scored by certified therapists and the other which was designed for~     children with developmental disabilities and is scored by the child's care provider. A~     sub-set of children will have a special type of MRI to evaluate any changes in the~     neurological structure of the brain.~      The Department of Pediatrics at the University of Arizona recently completed a collaborative~     study with the Neurologic Department at the Beijing Children's Hospital where the intense~     approach of five therapies per week is the SOC. The positive results prompted another~     investigation to determine if such an approach would be feasible in the United States. A~     compliance rate of 81% confirmed feasibility and the perception that parents who have a~     child diagnosed with CP will do whatever they can to improve their child's motor function.~   "
68020|NCT02167009|"~     Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track~     symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.~   "
68021|NCT02166996|"~     A single-center, prospective, randomized comparison with blinded assessment of cosmetic~     outcome.~      To compare cosmetic outcome of surgical defects of head and neck, repaired with~     non-resorbable monofilament sutures from the aspect of suture removal time 7 and 14 days.~     Data are gathered through a standardized form at the time of surgery concerning width and~     length of the surgical excisions, and if the patient has any systemic cortisone treatment or~     diabetes mellitus. At the time of surgery the patients are randomised to a suture time at 7~     or 14 days postoperatively and all receive the same written information about postoperative~     care and restrictions.~      Photographs of the scars are taken one month and one year after the procedure and rated~     using a visual analogue scale (VAS) by three independent assessors blinded to the~     intervention and suture time. The width of the scar is measured after one ear.~      Study hypothesis is that leaving non-resorbable monofilament sutures in clean surgical~     wounds in the head and neck area for up to 14 days does not lead to poor cosmetic outcome.~   "
76849|NCT02051439|"~     This study was designed to compare the party balloon assisted Valsalva with the conventional~     Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence~     duplex examination.~   "
68023|NCT02166970|"~     In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than~     3 months, metallic stent performance is superior to plastic stenting for palliation with~     respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent~     of drainage are issues that remain to be definitively decided. The optimal endoscopic~     management strategy is contentious. The investigators conduct the present study to~     prospectively in multi-centers compare unilateral (single) with bilateral (multiple)~     deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of~     these two deployment methods using metallic stents.~   "
68024|NCT02166957|"~     Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic~     approach had already been described for complex stenoses but never for disruption with loss~     of tissue and SES. Patients and methods: This is a retrospective observationnal study about~     patients referred for complete esophageal disruption and classified in two groups: 1/ Long~     disruption (> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS~     removal; 2/ Short disruption (< 5cm), consecutive to radiation therapy. All the procedures~     are performed according the anterograde retrograde approach, using CO2 and under X-rays~     guidance. We report the characteristeristics of the procedures, the efficacy, the time~     before discharge and refeeding, the complications, and the follow-up, especially the number~     of dilatation sessions for each group. The hypothesis is that anterograde retrograde~     endoscopic technique is safe and effective for the management of esophageal disruptions in~     patients for which the surgical treatment confers a high risk of morbidity and mortality.~   "
68025|NCT02166944|"~     The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND)~     patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related~     to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS,~     and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy~     pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation~     and rescue in motor function in animal model. Tamoxifen had shown ability of enhance both~     proteasome and autophagy pathway, therefore the investigators assume that Tamoxifen probably~     can ameliorate TDP-43 accumulation and inclusion body formation in ALS.~   "
68026|NCT02166931|"~     The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective~     in the promotion of resilience and resistance to stress-associated cognitive inhibition.~   "
68027|NCT02166918|"~     In the last decades the impact of several variables on patients' social functioning has been~     investigated with conflicting findings. The involved variables might be grouped in three~     main categories: a) disease-related variables; b) personal resources; c) context-related~     factors. The present study is aimed to identify factors that affect most real-life~     functioning of subjects with schizophrenia and to assess negative and depressive symptoms,~     neurocognitive deficits and impairment of social cognition. Domains of negative symptoms and~     cognitive dysfunctions most associated with impairment of real-life functioning will be~     identified and appropriate data analyses will be carried out to define whether it has a~     direct or indirect impact on real-life functioning. The research units of Turin and Genua~     will also investigate the relationships between insight into the illness and real-life~     social functioning. The research unit of Genua will evaluate prevalence and course of~     depressive symptoms, insight impairment and neurocognitive deficits, and will define the~     relationships of these aspects with suicidal behavior and real-life social functioning. The~     Naples research unit n.1 will investigate the hypothesis that deficits of preattentive and~     perceptual functions underlie impaired social cognition and negative symptoms. An~     electrophysiological study will be carried out in which abnormalities of event-related~     components and gamma rhythm synchronization, relevant to preattentive and perceptual stages~     of information processing, will be studied as endophenotypes of the disorder.~      The study will also investigate the heritability of disease-related variables by evaluating~     them in non-affected, first-degree relatives of subjects with schizophrenia. The research~     unit of Bari will test functionality of genetic variants relevant to dopaminergic signaling,~     that might confer risk for neurocognitive and related prefrontal dysfunction assessed by~     specific functional magnetic resonance imaging (fMRI) paradigms. The Naples research unit n.~     6 will perform an association study between selected putative schizophrenia genes and~     specific psychometric, neurophysiological and neurocognitive schizophrenia endophenotypes;~     moreover, the research unit will search for de novo copy-number variations (CNV) as putative~     risk factors for schizophrenia or schizophrenia endophenotypes and for de novo~     protein-altering mutations that may contribute to the genetic component of schizophrenia~     endophenotypes. The Naples research unit n. 5 will be responsible for defining a~     standardized protocol for the assessment of medical comorbidities in subjects with~     schizophrenia. All psychiatric research units will contribute to assess the role of factors~     related to the context in modulating the impact of variables related to the disease on~     real-life social functioning.~   "
68028|NCT02166905|"~     This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1~     inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly~     ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or~     primary peritoneal cancer who no longer have evidence of disease. Antigens (such as~     cancer/testis antigen [NY-ESO-1] protein) are found on many cancer cells. Vaccines made from~     NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may~     help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells.~     By finding them, the immune system may then work to control or eliminate the remaining~     cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase~     (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the~     efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC~     and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune~     responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in~     remission.~   "
68029|NCT02166892|"~     Previous studies demonstrated that children served themselves more food when using larger~     plates and bowels. The purpose of this study is to evaluate if self-served portions and~     caloric intake in normal weight and overweight children will be influenced by a specially~     designed eating plates compared to similar size normal plates.~   "
68030|NCT02166879|"~     The primary aim is to determine whether patients with suspected OSAHS as predicted by the~     STOP-BANG questionnaire will have an increased length of stay (LOS) in the postanesthesia~     acute care unit (PACU) compared with those without suspected OSAHS.~      The second aim will be to determine the LOS in patients with known sleep apnea by history.~     This length of stay will be compared with LOS in patient with an affirmative response to the~     STOP-BANG questionnaire to determine if prior knowledge of diagnosed sleep apnea will be~     associated with a lower LOS than in patients with suspected OSA.~      The third aim will be to characterize the adverse clinical outcomes (respiratory,~     cardiovascular, and neurological) associated with suspected OSAHS in patients who respond~     affirmatively to the STOP-BANG questionnaire and in those patients with known OSA. These~     data (including number of desaturations, bradypnea, brady- or tachycardia, and use of~     reversal agents) will be recorded by the PACU nursing staff. Unexpected admissions to the~     hospital and transfers to the intensive care units will also be measured. These data will~     help identify the most critical determinants of length of stay.~   "
69085|NCT02153073|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of~     granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules)~     in patients with hyperlipidemia in daily medical practice~   "
68031|NCT02166866|"~     This study defines cancer caregivers as unpaid individuals who provide physical, practical,~     and/or emotional care and support to the cancer patient in the home setting. They may~     participate in this study if care recipients and the caregiver are both adults (18 years or~     older), with the patient having been diagnosed with cancer.The 8 intervention sessions will~     target the five domains of Quality Of Life (emotional, physical, social, cognitive, and~     spiritual well-being), be provided in group settings, and be delivered in two 45-minute~     sessions each week over a 4-week period.~   "
68032|NCT02166853|"~     Numerous trials support the efficacy and safety of volatile anesthetic agents, namely~     inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients.~     Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and~     decreases pulmonary and systemic inflammation in experimental models of acute respiratory~     distress syndrome (ARDS).~      The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the~     effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in~     patients with ARDS.~   "
68033|NCT02166840|"~     Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of~     their jaundice with transpapillary stenting at endoscopic retrograde~     cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.~      Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative~     stenting in patients with obstructive jaundice due to periampullary tumour obstruction.~   "
68034|NCT02166827|"~     To evaluate the long-term efficacy of the NeuroAD system~   "
68035|NCT02166814|"~     The purpose of this study is to evaluate the efficacy and safety of combination of~     Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with~     essential hypertension and dyslipidemia.~   "
68036|NCT02166801|"~     Children with cerebral palsy (CP) have life-long motor disorders and are typically subjected~     to extensive treatment throughout childhood. Despite this there is a lack of evidence~     supporting the effectiveness of treatment aiming at improving motor function and activity in~     daily life. The primary area of interest of this research programme is to determine the~     effectiveness of an early intervention program in children younger than 12 months of age who~     are at risk of developing CP. A randomised control trial is planned, addressing hand use,~     mobility and communication in a home-based program. New treatment principles based on recent~     knowledge of brain plasticity will be employed.~      The overarching goal of this research programme is to develop and evaluate new intervention~     principles for children with neurodevelopmental disorders based upon theories of early~     learning induced brain plasticity. Our overall aims can be formulated as follows:~      To evaluate the effects of an early intervention programme on the overall development in~     children with risk of developing cerebral palsy and other neurodevelopmental disorders. The~     program includes intensive intervention towards the foci: hand use, mobility and~     communication in a home based program~      The hypothesis is that the design of the Small-Step-Program intervention, with clear foci on~     specific areas of development during different time periods and conducted in the child's~     home environment, will facilitate development and be more effective than usual care.~      The second hypothesis is that children learn what they practice, meaning that children will~     have a more rapid development within the focus of each specific step in the training, when~     compared to the, for the time being, untrained steps.~      The third hypothesis is that children's ability to learn within the different steps of the~     intervention programme will be influenced by the specific characteristics of any underlying~     brain pathology.~      The fourth hypothesis is that parents in the study group will be less stressed and can~     better cope with their child's situation than parents to children receiving usual care.~     Thus, the tools provided within the Small-Step-Program intervention, like education,~     supervision and feedback of how to practice communication and task performance will make~     parents more able to cope with the child's delayed development.~   "
68037|NCT02166788|"~     BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event~     affecting about 350 people a year in Australia. Globally it has been shown that patients~     with involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3~     management strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal~     lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different~     experts have strong and polarised opinions favouring either IL or more extensive I-IL with~     existing cases series reporting conflicting data on best cancer outcomes. No high level~     evidence proves which operation is best. HYPOTHESIS: There will be no significant difference~     in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of~     pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a~     rational evidence base for management for melanoma to the groin LNs by randomly assessing~     the effect of each operation on DFS, distant DFS, overall survival (OS), morbidity -~     including early complications and longer-term rates of lymphedema as well as comprehensively~     assessed QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and~     evaluate any health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634~     patients in 5 years. DESIGN: An Australian led, international, multi-centre,~     non-inferiority, phase III, prospective, randomised clinical trial comparing IL or I-IL for~     patients with metastatic melanoma to groin LNs and no evidence of pelvic disease on PET/CT.~     ENDPOINTS: DFS, Distant DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN~     metastases.~      OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for~     patients with groin metastatic melanoma. Proof of principle about extent of surgery when~     PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of~     other lymph node fields.~   "
68038|NCT02166775|"~     In this trial, the correlation between the psychopathological profile and sagittal balance~     unexplored to date spine will be studied. Indeed, a number of patients who benefited from~     well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly~     to it. The investigators wonder if there are biomechanical factors or factors of~     psychopathological order which might influence the effectiveness of treatment. This seems~     logical for the entire medical community, but it has never been demonstrated in a clinical~     trial.~   "
68039|NCT02166762|"~     This is a prospective clinical trial to determine the optimal QLV interval during~     implantation to achieve the best possible response from cardiac resynchronization therapy~     for heart failure patients.~   "
68040|NCT02166749|"~     The purpose of this study was to find out subjective and objective outcomes of patients~     undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years~     after the operation. The hypothesis is that there are similar outcomes after both types of~     operations.~   "
68041|NCT02166736|"~     Previous trials have demonstrated that the use of physiological assessment of stenosis~     severity using fractional flow reserve (FFR) is superior to angiographic assessment in~     percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical~     utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption~     rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost~     associated with Adenosine.~      Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for~     functional significance. The main benefits of the method compared to FFR are that the~     measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does~     not experience any discomfort from the measurement and procedural time could be shortened~     compared to when using FFR. This could potentially increase the adoption rate of physiologic~     assessment of coronary lesions.~      The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with~     patients assessed by FFR.~      Furthermore, the trial will be conducted as a registry based randomized clinical trial~     (RRCT) which is a novel strategy to conduct clinical trials. The randomization will occur~     online in the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based~     platform.~   "
68042|NCT02166723|"~     Patients with persistent irregular heartbeats also called persistent atrial fibrillation~     usually have a lower probability of curing their arrhythmia with ablation with heat called~     radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have~     shown.~      The emerging ablation with freeze(cryoablation) has not been studied for persistent atrial~     fibrillation but has been proven to be efficient in the paroxysmal type.~      We hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate~     of 70% after use of cryoablation at one year of follow up.~   "
68043|NCT02166710|"~     Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis.~     This major surgery is associated with a reduction in knee extensor muscle strength~     persisting several weeks after surgery. This decrease in strength correlates with poor~     functional recovery. Its cause is multifactorial, including a deficit of the quadriceps~     activation, an acute postoperative atrophy of the muscle and an important limitation related~     to postoperative pain.~      Peripheral nerve blocks using local anesthetics are frequently used for postoperative~     analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and~     allows early passive mobilization after surgery. This block also facilitates functional~     recovery and allows early discharge from the hospital. However, blocks involving the~     proximal femoral nerve contribute to quadriceps weakness for the duration of nerve blockade.~     Quadriceps weakness, in turn, results in functional impairment and increases recovery time.~     A possible long-term quadriceps weakness associated with the femoral nerve block has even~     been suggested in a recently published abstract. Hence, there is a need for an alternative~     technique that could minimize postoperative pain as well as the femoral nerve block without~     causing weakness of the quadriceps muscle.~      Femoral nerve block performed at the level of the adductor canal seems to be a promising~     alternative to the classic inguinal approach of the femoral nerve block. Studies comparing~     femoral nerve block performed at the canal adductor level to the inguinal approach reported~     a similar quality of analgesia, a reduction in motor block and a better functional recovery~     in the early postoperative period in the canal adductor block group. The long-term effect of~     femoral nerve block performed at the level of the adductor canal on knee extensor strength~     after surgery remains to be studied.~      This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h,~     48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal~     level compared to a simulated block.~      Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle~     strength when compared to a simulated block at 6 weeks after total knee arthroplasty.~   "
68044|NCT02166697|"~     The purpose of this survey is designed to investigate the treatment status of hypertensive~     patient with metabolic syndrome-related risk factors treated with candesartan cilexetil~     tablets (Blopress Tablets), as well as to assess relationships between risk factors~     (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular~     events in an exploratory manner.~   "
68045|NCT02166684|"~     The study aims to evaluate whether do-it-yourself devices for self-measuring health~     parameters by subjects can be used for obtaining useful data in scientific studies.~      Besides, the study aims to evaluate if increased awareness of own health status by~     self-monitoring health parameters also serves as motivational instrument for changing health~     behaviour.~   "
68046|NCT02166671|"~     This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine~     booster in healthy adults which received a full course of neonatal hepatitis B vaccination~     20-23 years ago.~   "
68047|NCT02166658|"~     Patients suffering from histologically or cytologically confirmed stage IV lung or breast~     cancer with progressive or recurrent brain metastases after prior external beam radiotherapy~     will receive treatment with cabazitaxel until progression of brain metastases (BM) or~     unacceptable toxicity.~   "
68048|NCT02166645|"~     The purpose of this study is to determine whether patient positioning (prone and supine~     positioning) contributes to the success of extubation in the immediate postextubation period~     of preterm infants.~   "
68049|NCT02166632|"~     The purpose of this study is to determine quantitative and qualitative differences in~     post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who~     receive administration of a newly approved, long acting local anesthetic branded as~     ExparelTM (bupivacaine liposome injectable suspension) introduced by one of two different~     administration methods.~      Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly~     into the joint capsule at the conclusion of the surgery, effectively bathing the joint in~     anesthetic solution.~      Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local~     infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9)~     standard sites at the conclusion of the surgery.~   "
68050|NCT02166619|"~     In this study, the investigators wondered whether bihemispheric transcranial direct current~     stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper~     limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the~     pattern of physiological variables involved in the recovery of these patients. For this~     purpose, patients included will be submitted to 10 sessions with active or sham~     bihemispheric tDCS associated with intensive and individual physical therapy session.~   "
68051|NCT02166606|"~     The objectives of this registry are to~        1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems~          involving the INGEVITY lead based on observations / events~        2. Gather data on actual number of MRI scans performed in the patient cohort implanted~          with an ImageReady system including information about scanned body parts.~        3. Collect physician feedback on lead handling with the INGEVITY lead~      in a real-life, market-released standard of care environment using devices on intended~     purpose and which are authorized to bear the CE (Communauté Européenne) marking / are~     approved for use in the applicable area of participating centers. No additional invasive or~     other burdensome examinations are to be carried out other than the ones conducted by the~     centers per their general standard of care.~   "
68052|NCT02166593|"~     1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C~          but inadequately controlled triglyceride level by atorvastatin monotherapy~        2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is~          clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each~          group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin~          sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately~          controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized,~          double blind setting.~        3. Phase and design : A multicenter, double blind, randomized, active controlled,~          parallel-design, Phase 3 study~        4. Duration of study : 12 months from the IRB approval date~        5. Duration of administration : 4-week single blind run-in period plus 8-week double blind~          treatment period~   "
68053|NCT02166580|"~     Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is~     compared with the gold standard of invasive measurements. Cardiac output is derived by the~     PICCO monitor.~      Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the~     prediction of fluid responsiveness will be defined.~   "
68054|NCT02166567|"~     In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods~     rely on physical properties of the spermatozoa, such as the swim-up methods and density~     gradient centrifugation. It is now known that current processing of spermatozoa does not~     prevent the admixture of spermatozoa with damaged genetic material. The latter have a~     negative impact on the outcome of ART. The investigators developed a new method for the~     processing of spermatozoa with intact genetic material based on flow cytometry and sorting~     (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of~     this novel method of sperm sorting on the outcome of ART.~   "
68055|NCT02166554|"~     The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel~     was safe to use, and was effective for the prevention/reduction of adhesion formation~     following gynecological surgery~   "
68056|NCT02166541|"~     A randomized control trial investigating Biomechanical Correction of the Spine according to~     Kozyavkin (BCSK) which is a part of the treatment concept Intensive Neurophysiological~     Rehabilitation System (INRS). BCSK is used with the aims to reduce muscle tone and improve~     gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.~   "
68057|NCT02166528|"~     Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures,~     degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP),~     urinary incontinence(UI) and genital tract injury. Although it does not pose a serious~     threat to life, but affect the patient's quality of life seriously in the physical,~     psychological, social behavior and other aspects. With the growing aging population, the~     incidence rate has gradually increased, and increasing demands for people's quality of life~     simultaneously, more and more attention was raised to PFD as common chronic diseases.~      In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of~     PFD have made great progress, especially in developing gynecological urology theory and~     reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind,~     especially susceptibility gene localization and functional studies did not get enough~     attention.~   "
68058|NCT02166515|"~     As human aging, 50% of women will be faced with the threat of cancer, especially~     gynecological malignancies. Ovarian, cervical and endometrial cancer are three major~     gynecological malignancies. In recent years, the incidence of cervical cancer, especially in~     young women significantly increased; ovarian cancer, although the incidence of malignant~     tumors in the female reproductive system ranked second, but its mortality rate already in~     the first place; and the morbidity and mortality of endometrial cancer is also rising.~      The key to gynecologic malignancies is how to early diagnose and treat. With the advancement~     of science and technology, such as molecular biology techniques widely used in the medical~     field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is~     expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for~     linkage analysis for gynecological malignancies possible. Therefore, the investigators~     intend to find specific mutations to provide a new early screening approach for~     gynecological malignancies, which in later result in early diagnosis and specific treatment~     for gynecological malignant tumors.~   "
68059|NCT02166502|"~     The purpose of this study is to determine whether the current dose of nevirapine recommended~     in the Ontario Ministry of Health vertical transmission prevention protocol achieves~     therapeutic drug levels in newborn infants at high risk of HIV infection.~   "
68060|NCT02166489|"~     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)~     therapy in chronic renal failure due to autosomal dominant polycystic kidney disease~     (ADPKD).~   "
68061|NCT02166476|"~     Carbavance, (meropenem/vaborbactam) is being compared to piperacillin/tazobactam in the~     treatment of adults with cUTIs or AP~   "
68062|NCT02166463|"~     This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to~     see how well they work compared to combination chemotherapy alone in treating younger~     patients with newly diagnosed Hodgkin lymphoma. Combinations of biological substances in~     brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin~     lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin~     sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. It is not yet known if combination~     chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin~     lymphoma.~   "
68063|NCT02166450|"~     The aim of this study is to evaluate the influence of presence of oral fungal infection,~     which leads to denture-related stomatitis, on blood pressure, endothelial function and~     immune cell phenotype in patients wearing dentures.~   "
68064|NCT02166437|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly~     divided following daily teriparatide in Japanese patients under clinical practice. The~     participants are treated in the investigators hospital, who are under severe osteoporotic~     condition.~   "
68065|NCT02166424|"~     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty~     acids for pregnant women with depressive symptoms.~   "
68066|NCT02166411|"~     The aim of this study is to compare operative data and early postoperative outcomes of~     laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using~     conventional sutures .~   "
68067|NCT02166398|"~     A randomized, open-label, single dose, two-way crossover clinical trial to compare the~     safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a~     single oral administration in healthy male volunteers~   "
68068|NCT02166372|"~     T2DM has become a major health burden for our society. More and more data support the~     relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in~     the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI~     over 27.5 in Asia.~      The evidence reviewed above strongly points to the need for a large randomized, controlled~     trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2~     diabetes Mellitus. This study is expected to provide very significant findings about the~     natural course of diabetes in obese diabetic patients.~   "
68069|NCT02166359|"~     Patients with chronic kidney disease (CKD) have a markedly higher prevalence of~     cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major~     cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use~     of glucose as the osmotic agent in PD solutions has been associated with a variety of~     metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia~     and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD~     patients. A study showed that patients with high triglyceride levels were more~     insulin-resistant than those with normal triglyceride levels.~      Insulin resistant is associated with atherogenic response represented high plasma levels of~     monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high~     triglyceride level may play an important role to CV outcome of PD patients. PD solution~     decreasing triglyceride levels is essential in PD patients.~      Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase~     ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of~     icodextrin, which is catabolized into maltose, considerably reduces caloric uptake.~     Therefore, icodextrin may have an additional favorable effect on triglyceride level.~      There are several studies regarding the effect of icodextrin on triglyceride level in PD~     patients. However, the outcomes are controversial, some studies showed no association~     between icodextrin and triglyceride change, even the others showed positive results but~     these also have study design limitations such as non-randomized study or secondary primary~     outcome. It is not clear about the effect of icodextrin on triglyceride especially in PD~     patients without diabetes.~      The investigators therefore want to conduct a randomized, cross-over, controlled multicenter~     trial comparing icodextrin solution and glucose solution in PD patients with and without~     diabetes, focusing on triglyceride change.~   "
68070|NCT02166346|"~     Transverse myelitis (TM) is an inflammatory disorder of the spinal cord that leads to~     disabilities of gait. Dalfampridine, a sustained-release potassium inhibitor has been shown~     to be effective in improving gait and other neurologic functions in multiple sclerosis.~     Dalfampridine has the potential to improve neurologic function in patients with transverse~     myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis.~     The in a clinical trial to test the efficacy of dalfampridine in TM.~      The clinical trial that the investigators propose to conduct will focus on TM and will~     evaluate the dalfampridine in primary neurologic outcome, 25-foot timed walk, and several~     secondary outcomes including valid behavioral and neurophysiological tests.~      This is a re-launch of the previous trial, which now includes additional behavioral and~     clinical testing.~   "
68071|NCT02166333|"~     Vitamin D supplements might substantially reduce the risk of falls, potentially by more than~     25%. The proposed study is a clinical trial that will determine the effects of 4 doses of~     vitamin D (200 International Units [IU]/day, 1000 IU/day, 2000 IU/d and 4000 IU/d) as a~     means to prevent falls in high-risk adults, ages 70 and older. Results of this trial will be~     directly relevant to public health and clinical guidelines, and will immediately influence~     policy.~   "
68072|NCT02166320|"~     Self expandable stent (SEMS) constitutes the main palliative treatment in advanced~     esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of~     dysphagia. The duration of this effect is however questionable. The design of SEMS can be of~     importance since the device can dislodge and as a consequence of that dysphagia recur. The~     hypothesis has therefore been formulated that a partially covered SEMS is associated with~     less tendency to dislocate as compared to those SEMS, recently developed, which are covered~     through their entire length.~   "
68073|NCT02166307|"~     Aging in human physically refers to a multidimensional process that all the changes were~     accumulated in a person over time. These aging changes are responsible for the progressive~     increases in the chance of disease and death associated with them. So far, there are several~     theories have been developed to understand the aging process, such as cross-linking, which~     is led by Maillard Reactions. Maillard Reaction is a complex series of reactions between~     reducing sugar/aldehydes and amino groups on proteins. Under physiological conditions,~     aldehydes are products of various exogenous and endogenous amines catalyzed by~     semicarbazide-sensitive amine oxidase (SSAO), a family of heterogeneous enzyme. It was~     reported that SSAO shows a significant higher catalytic activity, producing more aldehydes~     in age-related diseases. However, SSAO is not a perfect candidate to be monitored for~     evaluating aging, because it is widely distributed in tissues, which are not readily~     accessible sample-sources for clinical applications. In this work, the investigators have~     found 6 biomarker candidates by developing a standard-free, label-free MS-based proteomics~     method based on standard protein (human serum albumin, the highest abundance protein in~     human plasma) model in vitro. Then, the investigators wanted to verify these biomarker~     candidates by clinical plasma samples to see if there is significant quantitative difference~     among people with different ages.~   "
68074|NCT02166294|"~     In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K~     will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K~     is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for~     use as a wound covering for dermal ulcers and defects. It is designated as a Human Cell &~     Tissue Product (HCT/P) by the U.S. FDA.~   "
68075|NCT02166281|"~     Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase~     inhibitor.~      However it is difficult to establish whether it is due to the knowledge of the disease or~     the treatment administred.~      The investigators designed a cohort study in which questionnaires for the assessment of~     sleep quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State~     and Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of~     life in general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS~     (Restless Legs Syndrome Rating Scale) will be prospectively administered to patients with~     early breast cancer at baseline and during adjuvant treatment with aromatase inhibitors.~      As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn~     over and BMI.~   "
68076|NCT02166268|"~     The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment~     of rhinitis in an environmental challenge chamber.~   "
68077|NCT02166255|"~     This phase I trial studies the side effects and best dose of small interfering ribonucleic~     acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401) in treating~     patients with melanoma, kidney, or pancreatic cancer, or other solid tumors that have spread~     to other parts of the body or that cannot be removed by surgery. There are factors in immune~     cells in the blood that inhibit their ability to kill cancers. Treating white blood cells~     with one of these factors in the laboratory may help the white blood cells kill more cancer~     cells when they are put back in the body.~   "
68100|NCT02164903|"~     The broad goal of this study is to investigate if differences exist (and in which areas and~     of what magnitude) in QoL and symptoms of patients with CML being treated with first line~     therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an~     additional objective is to characterize medication-taking behavior associated with imatinib~     or dasatinib.~   "
68078|NCT02166242|"~     Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed~     that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell~     growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200~     mg dose ethaselen could be well tolerated, in pre-clinical study we found that,~     approximately 50% non-small cell lung cancers harbored high thioredoxin reductase~     expression(IHC result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result~     showed that 1200mg ethaselen per day was safety and tolerated by Chinese malignant tumor~     patients.In pre-clinical research, our group found that, elevated of thioredoxin reductase~     activity was associated with the expression of thioredoxin reductase tested by~     immunohistochemistry, which means high expression of this enzyme may be a favourite~     predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.~   "
68079|NCT02166229|"~     To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve~     the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital~     ulcers, and joint contractures.~   "
68080|NCT02166216|"~     Competitions such as marathon running and endurance cycling events are increasingly popular~     and represent an important motivation for sustaining training among leisure-time athletes.~     However, there is a concern that prolonged, high-intensity exercise may increase the risk of~     cardiovascular (CV) events. Following prolonged high-intensity exercise there is an increase~     in levels of circulating markers of myocardial damage such as Troponin I (TnI). The precise~     cause and clinical significance of this TnI increase is unknown.~        -  The primary objective of this study was to determine the relationship between~          high-sensitive cardiac troponin I (hs-cTnI) levels and coronary artery disease and~          cardiovascular outcomes in 1000 presumably healthy leisure sport athletes that~          participated in a 91 km long, high intensity endurance cycling competition.~        -  The secondary objective was to assess the relationship between other CV risk factors,~          fitness level and outcomes following high intensity endurance cycling competition in~          the same population.~   "
68081|NCT02166190|"~     Malignant obstructive jaundice is a common complication of advanced stage pancreatic~     adenocarcinoma and cholangiocarcinoma. Over 50% of common bile duct (CBD) obstructions are~     due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis.~     Biliary drainage with placement of self-expanding metal stents (SEMSs) for palliation is the~     therapy of choice in this set of patients. Conventional stent placement provides palliation~     for a limited duration only and these subjects come back with obstructive jaundice. Due to~     age, comorbidities, malignant disease status, it is better to conduct reduced number of~     therapeutic endoscopies to reduce the number of complications. Additionally, only biliary~     stenting itself may provide only palliation, and not increase the duration of survival.~      Currently, there are only two therapies. Recently, photodynamic therapy (PDT) has been~     evaluated as a palliative and potential neoadjuvant modality. Therefore if RFA confers~     similar benefits, then it may potentially be used as an alternative to PDT, given the lower~     adverse event profile. More recently, RFA has been recognized for its potential in~     palliative treatment of malignant biliary strictures. Based on the published data, RFA~     provides palliation and seems to increase survival duration in pancreatic cancer. Our own~     limited experience shows the same. The goal of this randomized controlled trial is to~     definitely confirm the benefit of Radiofrequency ablation (RFA) in providing increased~     survival time and quality of life in patients with non-resectable cholangiocarcinoma and~     pancreatic cancer. These benefits will improve clinical practice by making RFA the new~     standard of care for unresectable cholangiocarcinoma (CCA) and pancreatic cancer (PC). It~     will also enhance scientific knowledge by opening the door for new opportunities, e.g. RFA~     as a potential use for neoadjuvant therapy or as a downstaging agent for surgically~     resectable patients.~   "
68082|NCT02166177|"~     'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell~     therapy, as adjunct immunosuppressive treatment in the context of liver transplantation~   "
68083|NCT02166164|"~     In this prospective trial we aim to investigate the intra-individual and inter-individual~     variance in secondary hyperalgesia following pain elicited by the experimental pain model:~     Brief Thermal Sensitization.~      Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing~     Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary~     hyperalgesia.~   "
68084|NCT02166151|"~     The study is designed to assess the efficacy and safety of monthly injections of Omalizumab~     150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive~     to convetional therapy by antihistamins or oral corticosteroids.~   "
68085|NCT02166138|"~     The condition to be studied is post-surgical scarring following primary total knee~     replacement, specifically whether fractional non-ablative laser therapy can be used to~     significantly decrease the morbidity of scarring.~   "
68086|NCT02166125|"~     The purpose of this prospective registry is to assess long term data on efficacy, safety and~     clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue~     within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate~     technical feasibility, clinical outcome, safety profile and overall clinical management~     through medical chart review. The procedures the investigators are evaluating are all~     clinically indicated and will not be prescribed to someone to participate in this research~     study.~   "
68087|NCT02166112|"~     Incisional hernia is the most frequently seen long term complication in surgery causing much~     morbidity and even mortality in patients. Despite studies on the optimal closing technique~     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20~     %. It has been established that implementing a mesh reduces recurrence of the incisional~     hernia but still the results of repair are often disappointing. Incisional hernias can~     become increasingly complex due to complicated abdominal wall defects caused by a disturbed~     anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save~     to repair the incisional hernia by means of a synthetic mesh and other augmentation tools~     need to be implemented.~      In the recent years the use of biological meshes has been gaining popularity. Recent reports~     of the use of collagen-based prosthesis have suggested that they support new vessel growth,~     do not excite a significant foreign body reaction, form fewer adhesions, are well~     incorporated into host tissues with minimal wound contraction, and can be used in grossly~     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a~     source tissue and processed for medical use but they vary widely in their processing~     methods. They include tissues of human or animal origins, both chemically cross-linked and~     non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current~     studies investigating the effectiveness of these meshes are small and have short periods of~     follow-up. These shortcomings can be explained to high cost of the meshes and unclear~     indication when to use a biological mesh.~      The aim of this study is investigate the short and long term effects of the Permacol©~     biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what~     is the true indication to use a biological mesh.~   "
68157|NCT02165397|"~     The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination~     with Rituximab in subjects with Waldenström's Macroglobulinemia.~   "
68158|NCT02165384|"~     The purpose of this study is to determine if the Hummingbird ear tube delivery system is a~     safe and effective way to put ear tubes in place.~   "
68088|NCT02166099|"~     The purpose of this registry is to record information and evaluate the impact of SpyGlassTM~     Direct Visualization System for choledochoscopy on the management of pancreatico-biliary~     disorders. The registry will evaluate diagnostic performance and overall clinical management~     impacted by SpyGlass.~      This multi-center registry has been initiated:~        -  To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on~          the clinical management of pancreatico-biliary disorders including malignancies.~        -  To assess the sensitivity, specificity, accuracy, technical feasibility, safety and~          cost effectiveness of SpyGlass and compare it to other diagnostic modalities.~   "
68089|NCT02166086|"~     The purpose of this registry is to record information and evaluate the impact of advanced~     imaging techniques on the management of pancreatico-biliary disorders. The registry will~     evaluate diagnostic performance and overall clinical management impacted by advanced imaging~     techniques.~   "
68090|NCT02165033|"~     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and~     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway~     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly~     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is~     used as a bronchodilator in the management of reversible airways obstructive pulmonary~     disease. Budesonide and Procaterol therefore have complementary effects, treating two~     different components of asthma.~   "
68091|NCT02165020|"~     The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2~     after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy~     with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.~     Thirty-six patients with a low- to intermediate-risk prostate cancer according to the~     D'Amico classification are included in the present protocol. The main characteristics of the~     study are that the patients benefit of a reduction of the treatment duration from 40 to 20~     fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of~     hyaluronic acid in the perirectal fat between the rectum and the prostate.~   "
68092|NCT02165007|"~     The study is designed as a Pilot trial of reduced intensity Haploidentical HSCT in patients~     with sickle cell disease and thalassemia. The purpose of the study is to assess the safety~     and toxicity of reduced intensity conditioning haploidentical hematopoietic stem cell~     transplantation.~   "
68093|NCT02164994|"~     This clinical study is an open, controlled, prospective, single center, single-surgeon,~     post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of~     the femtolaser-assisted astigmatic keratotomy.~   "
68094|NCT02164981|"~     The primary objective of this study is to investigate whether a single infusion of~     intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5%~     dextrose solution) at in treating positive and negative symptoms of schizophrenia~   "
68095|NCT02164968|"~     INTRODUCTION~      Lung function assessment of preschool children is hindered by their limited co-operation in~     conventional tests such as peak expiratory flow (PEF) or spirometry and the methods~     available for younger children are, again, laborious and time consuming. However, impedance~     pneumography (IP) records indices of airway obstruction during normal sleep at home and has~     been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).~      AIM OF THE STUDY~      The general purpose of this study is to assess the clinical value of the information~     provided by overnight home recording of tidal breathing by means of IP technique in young~     children with asthmatic symptoms and inhaled corticosteroid (ICS) medication.~      The main hypothesis is that IP measurement can distinguish between groups whose asthmatic~     symptoms recur or do not recur after ending the ICS drug treatment period.~      METHODS~      The study recruits 1-5 year old children (n=75) who have presented at the emergency room due~     to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed~     based on the national guidelines.~      The subjects will perform three overnight IP measurements at home at two weeks intervals~     close to and after ending of the treatment period.~      SIGNIFICANCE OF THE STUDY~      Being an affordable, simple and convenient ambulatory measurement method, IP may bring~     needed objectivity to asthma diagnostics and asthma drug response assessment in young~     children.~   "
68096|NCT02164955|"~     This registry is a prospective, multi-center, observational study and will collect safety~     data on multiple myeloma adult patients who have received at least two prior therapies and~     take IMNOVID (pomalidomide) as part of standard care.~      The registry will remain open until 500 patients will have received at least 3 cycles of~     pomalidomide. All patients registered will be followed up prospectively for up to 3 years~     following the end of pomalidomide treatment. During this time the incidence of second~     primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be~     assessed.~   "
68097|NCT02164942|"~     This is a prospective, single arm, observational study examining aurora kinases and~     circulating tumor cells in subjects with bladder cancer being treated with standard~     cisplatin-based chemotherapy.~   "
68098|NCT02164929|"~     The purpose of this study is to assess the effectiveness of transversus abdominal plane~     (TAP) block, thoracic epidural or paravertebral block (PVB) for controlling postoperative~     pain when compared with opioid you self-administer in your vein using a PCA device. The~     primary outcome will be postoperative opioid consumption within 24 hours after surgery. A~     total of 120 subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA~     or no block (PCA alone).Patients in all groups will be cared for using an established~     enhanced recovery after surgery (ERAS) pathway incorporating a multimodal analgesic regimen~     using IV acetaminophen and postoperative PCA fentanyl.~   "
68099|NCT02164916|"~     This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with~     or without vemurafenib works in treating patients with colorectal cancer that has spread to~     nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be~     removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known~     whether irinotecan hydrochloride and cetuximab are more effective with or without~     vemurafenib in treating colorectal cancer.~   "
69086|NCT02153060|"~     The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known~     hospitals in China. In order to report the efficacy and safety of different dose~     dexamethasone in treating the immune thrombocytopenia (ITP).~   "
68101|NCT02164890|"~     Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in~     high-risk patients, such as immunocompromised patients. Candida is currently the predominant~     fungal pathogen in these patient populations and is associated with significant morbidity~     and a high mortality.~      Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal~     agents, the echinocandin lipopeptides, that has potent in vitro and experimental in vivo~     activity against a variety of pathogenic Candida species and Aspergillus species. Its~     applied indications are so the treatment and/or the prophylaxis of Candida and Aspergillus~     infections. MCF is currently licensed for the treatment of candidiasis at doses of either~     100 or 150 mg a day.~      The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in~     the steady state divided by the MIC (AUC0-24/ MIC ratio).~      On one hand:~      - It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio~     between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an~     AUC/MIC ratio < 3. In the case of infections by Candida parapsilosis, which exhibits drug~     MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio >285 achieve~     microbiological clearance, as opposed to 82% of those below that exposure level.(1)~      On the other hand:~        -  It is well known that patients of intensive care units (ICU) are characterized by~          particular pharmacokinetic parameters with higher apparent volume of distribution~          (VC/F) and/or higher apparent systemic clearance (CL/F). In a population of healthy~          volunteers, it was observed that CL/F of MCF presents a high interpatient~          variability.(2)~        -  Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses~          has not been investigated so far. In particular, lower AUCs might be reached in~          patients having the highest VC/F values. Such patients would then be at risk of therapy~          failure and would benefit from individualized-dosing strategies.~      In this context, the study of the pharmacokinetics of MCF in critically ill patients seems~     to be necessary.~   "
68102|NCT02164877|"~     The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial~     translocation and mucosal immunology in patients with Crohn's disease.~   "
68103|NCT02164864|"~     The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen~     of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE DAT) and 150mg~     dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple~     Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA~     <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI~     with stenting (elective or due to an Acute Coronary Syndrome).~      The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT~     in terms of safety. Safety will be determined by comparing the rates of bleeding events,~     assessed using the modified International Society of Thrombosis and Haemostasis~     classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.~   "
68104|NCT02164851|"~     The goal of this study is to compare the characteristics of echocardiography and different~     monitoring devices in shock patients, the relationship of device parameters to biomarkers~     associated with shock, and determine if these any of these add clinical utility when~     predicting the cause of shock. We will perform a prospective, observational study of~     patients found to have shock physiology in the ED and follow them to determine the final~     shock category and ultimate outcomes.~   "
68105|NCT02164838|"~     This trial will be the first study of axitinib in children and adolescents. The primary~     objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or~     recommended Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid~     tumors. Additional objectives include measurement of pharmacokinetic and pharmacodynamic~     parameters, description of the toxicity profile of this agent in children and adolescents,~     and assessment of response within the confines of a Phase 1 trial. A standard rolling 6~     design will be used for dose escalation. Further development of axitinib will focus on~     development of a joint cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric,~     adolescent and young adult translocation renal cell carcinoma.~   "
68106|NCT02166060|"~     The purpose of this study is to determine the role of ivabradine in cardiac~     resynchronization recipients with an unsatisfactory percentage biventricular pacing.~      The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV~     treated with optimal medical therapy as clinically indicated who received CRT-D device more~     than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest~     and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up~     of patients in the study will be at least six months.~   "
68107|NCT02166047|"~     This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically~     suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being~     treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts.~     Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of~     the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current~     oral antiviral treatment for the entire duration of the study. Cohorts A, B, and C will~     consist of a different treatment period of 4, 8, or 12 weeks, respectively, and will be~     followed to Week 48. After Cohort A completes treatment, a safety review will be conducted~     by an external data monitoring committee prior to beginning Cohort B. Another safety review~     will be conducted after Cohort B completes treatment prior to beginning Cohort C.~   "
68108|NCT02166034|"~     The purpose of this study is to determine whether school gardens influence children's~     dietary intake, nutritional knowledge, and other outcomes.~   "
68109|NCT02166021|"~     The purpose of this study is to to evaluate the optimal dosage and the way of administration~     of autologous mesenchymal bone marrow stem cells (MSC) either in maximal proximity of the~     lesions in the CNS or by intrathecal injection to the CSF.~   "
68110|NCT02166008|"~     -  Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in~          patients taking dual antiplatelet agents~        -  Study Design: Single center, double-blind, randomized-control trial study~        -  Study drug: Repamipide vs. placebo~        -  Assessment criteria The patients will be discharged from the study when one of the~          followings occurred,~             1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up~             2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy~             3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy~             4. Evidence of recurrent myocardial infarction from stent thrombosis~   "
68111|NCT02165995|"~     The goal of this clinical research study is to learn about using Navigated Transcranial~     Magnetic Stimulation (nTMS) in patients having surgery to remove a brain tumor in areas of~     the brain that control movement (motor function) and/or speech.~      nTMS is a system designed to map the brain's function relating to movement and speech.~   "
68971|NCT02154568|"~     Computer simulations are being developed to predict air flow abnormalities in the airways of~     patients with lung disease. The purpose of this study is to obtain actual gas flow~     measurements in the lungs of healthy patients and patients with lung disease and use these~     measurements to validate the computer models.~   "
68112|NCT02165982|"~     Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un~     échantillon clinique à un échantillon de témoins issus de la population générale.~      Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de~     patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les~     caractéristiques de l'activité physique et la dépendance à l'exercice physique en~     comparaison avec des sujets issus de la population générale appariés pour l'âge et le sexe.~      Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus~     dépendants à l'exercice physique que des sujets de la population générale de même âge et de~     même sexe.~   "
68113|NCT02165969|"~     The purpose of this study is to compare a subject's sense of smell before and after~     endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory~     process, fracture, defect, etc.) and use the information collected to validate approaches to~     surgery that will minimize side effects to the sense of smell function. Data will be~     collected using a smell identification test along with two questionnaires. In addition,~     demographic, medical history, treatment, outcome, and follow-up information will be~     collected.~   "
68114|NCT02165956|"~     The purpose of this study is to determine whether a new infant cereal has an effect on~     weight gain and intestinal microbiota compared to a standard cereal in healthy infants .~   "
68115|NCT02165943|"~     This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients~     treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA).~     There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in~     patients identified during the retrospective portion of the study. It is thought that the~     inclusion of BMA will facilitate the resorption of the graft material, leading to better~     long-term bone healing.~   "
68116|NCT02165930|"~     To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting~     Conditions with 40% Ethanol Compared with Water in Healthy Volunteers~   "
68117|NCT02165917|"~     Endometriosis is a common disease of women in the reproductive age and is an important cause~     for female infertility. Endometriosis is often associated with the development of adhesions~     which further compromises the fertility of the affected women. The main purpose of this~     study is to investigate the pregnancy rate one year after excision of endometriosis and~     application of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the~     patients will receive traditional endometriosis treatment with the excision of the~     endometriotic lesions only. The other half will additionally receive a gel which can reduce~     adhesion formation (Hyalobarrier®). Further study objective is the investigation in the~     development of different types of endometriosis-associated pain over a period of one year.~     Potential study participants are women with endometriosis-associated pain and with a desire~     to have children. It will be investigated in the study if the use of Hyalobarrier® will~     result in a higher pregnancy rate due to reduced adhesion development.~   "
68118|NCT02165904|"~     The study goes on 24 months, with recruiting, treatment and follow period for all patients.~     The first day for each patient will be the first cellular administration. 3 doses will be~     administrated every 3 months from first dose.~      When the clinical trial finishes, it will be done a completed check of all obtained~     parameters.~   "
68119|NCT02165891|"~     Despite the improvement in the technology available for diagnosing and treating empyema, the~     management of empyema in children remains controversial.~      The purpose of this study is to compare the efficacy and safety of two common technical~     approach used for pleural effusion drainage in the treatment of childhood empyema.~   "
68120|NCT02165878|"~     KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) is a~     nation-wide, ten-year longitudinal cohort study, launched in 2011. The aim of the study is~     to assess the characteristics and risk factors of progression and complications of CKD of~     Korea. Pediatric sub-cohort of KNOW-CKD is planned to enroll 450 children with CKD, stage I~     to V (pre-dialysis).~   "
68121|NCT02165865|"~     The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary~     research effort with the goal of restoring form and function to unilateral or bilateral~     upper extremity amputees by vascularized composite allotransplantation of the hand/upper~     extremity (hand transplantation). Hand transplantation includes transferring upper~     extremities/hands from deceased human donors to patients with single or bilateral hand or~     arm amputation. The purpose of the trial is to study functional, psychological, and~     immunological outcomes of human upper extremity allotransplantation.~   "
68122|NCT02165852|"~     Because the ampulla of Vater is strategically located at the confluence of the pancreatic~     and common bile ducts, endoscopic resection of papillary neoplasms may be technically~     different from endoscopic mucosal resection in other parts of the gastrointestinal tract.~     The best method of endoscopic ablation and the optimal period for surveillance have not been~     established.~   "
68123|NCT02165839|"~     PRIMARY OBJECTIVE(S):~      The purpose of this study is to test the efficacy of brief behavioral therapy versus control~     condition that accounts for time and attention (nutrition education) in the treatment of~     insomnia in humans.~      SECONDARY OBJECTIVE(S):~      To assess the impact of different biomarkers on sleep disruption and other patient reported~     outcomes~   "
68124|NCT02165826|"~     The purpose of this study is to evaluate discontinuation rates of roflumilast using an~     up-titration regimen for the first 4 weeks of treatment compared with continuous treatment~     of 500 μg one daily (OD) during the entire 12-week main period, and to evaluate if~     participants who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg~     roflumilast OD similar to that observed in other participants with the 500 μg OD dose.~   "
68236|NCT02164162|"~     In Parkinson's disease, gait disturbances represent one of the most disabling motor~     symptoms, frequently associated with an increased risk of falls, loss of independence and a~     negative impact on quality of life. In recent years, the interest in automated robotic~     devices for gait training for Parkinson's Disease patients has grown. With their consistent,~     symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive~     inputs that may increase cortical activation and improve motor function while minimizing the~     intervention of a therapist. So the main aim of this study will be to analyze, through a~     clinical and an instrumental evaluation, the effectiveness of a Lokomat gait training in~     subjects affected by Parkinson's disease in comparison to a ground conventional gait~     training.~   "
68125|NCT02165813|"~     This is a multi-centre (RDH and ASH), phase IV, double-blind, randomised, placebo-controlled~     trial of oral NTZ for the treatment of acute gastroenteritis requiring admission to~     hospital. Four hundred children aged between three months and less than five years of age~     will be enrolled. Study participation would be from the point of enrolment until 60 days~     after enrolment. Enrolment will occur within 48 hours of admission to hospital. Enrolled~     participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo. Other treatment and~     management will be as per the standard of care described in the admitting hospital's~     guidelines and will be ultimately the decision and responsibility of the named medical~     consultant. Stool samples will be collected at the point of admission. Solicitation of~     symptoms will be by review of routinely collected medical data recorded in the participant's~     medical record, and will be supplemented by completion of study specific diary cards until~     discharge. All participants will be followed up at day 7 after enrolment (by telephone if~     already discharged) to ascertain symptoms occurring in the intervening period. At days 30~     and 60 after enrolment a clinical record review will be conducted for all participants to~     ascertain health care attendances following discharge.~   "
68126|NCT02165800|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic~     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary~     and sexual function disorder. However, 32%-44% patients still suffered from urinary and~     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).~      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of~     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the~     protection of urinary and sexual function of male mid-low rectal cancer patients. The~     results showed that L-PANP-TME significantly decreased incidence of urinary and sexual~     function disorder. In order to further confirm our early work, we design a multiple-center~     randomized controlled clinical trial to compare differences in urinary and sexual function~     protection and long-term outcomes between L-PANP-TME and O-PANP-TME.~   "
68127|NCT02165787|"~     In the cross-sectional component of this study, our overall objective is to gather a large~     pool of data from which we can generate gait profiles. These profiles will consist of a~     constellation of gait (+/- electrophysiological) parameters associated with a particular~     neurological diagnosis or specific lesion(s) in neuroanatomical systems. Once developed,~     these profiles can be compared for differences and similarities; allowing insights into the~     specificity of the effect on gait of a given diagnosis or lesion in the case of the former~     and redundancy of neuroanatomical systems in that of the latter. A longitudinal component of~     the study will look at the evolution of gait parameters over time in a group of patients~     with spinal cord injury.~   "
68128|NCT02165774|"~     Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4~     tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil,~     St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after~     neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF~     (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological~     assessments, patients who agree will also undergo neurophysiological investigation of the~     lower urinary tract, i.e. recording of current perception thresholds, sensory evoked~     potentials, and electroencephalography after stimulation of the urethra and bladder.~   "
68129|NCT02165761|"~     To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic~     vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 /~     heparin antibodies (anti-PF4 / H antibodies).~   "
68130|NCT02165748|"~     Aim of this prospective observational study -in patients undergoing craniotomy for supra or~     infratentorial surgery as elective or emergency procedure- is to test the hypothesis that~     severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased~     incidence of infections within the first postoperative week (pneumonia, blood stream,~     urinary, surgical site/wound and cerebral infections)(NCT01923571).~   "
68131|NCT02165735|"~     The purpose of this study is to rigorously assess a program designed to empower patient~     living with HIV, to improve their health care and health, and to reduce disparities.~   "
68132|NCT02165722|"~     The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit~     increases adolescent vaccination rates, particularly influenza and human papillomavirus~     (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV)~     vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to~     national guidelines. The investigators will conduct a randomized cluster trial of this~     toolkit in diverse primary care practices with electronic medical records (EMRs).~   "
68133|NCT02165709|"~     Women undergoing surgical sterilization will be interested in risk reducing salpingectomy,~     and surgeons performing the procedure will be able to successfully complete the~     salpingectomy.~   "
68134|NCT02165696|"~     Lymphedema is the result of accumulation of fluid and other elements in tissue spaces~     because of an imbalance between the production of fluid interstitial and transport.~     Lymphedema can cause significant physical and psychological morbidity. Prevalence of~     lymphedema in patients after breast cancer surgery is 12-60% and the incidence is~     12-26%.Psychological and social consequences of secondary lymphedema related breast cancer~     have been little recognized and documented. Although, it have performed many studies related~     secondary lymphedema it not found sufficient evidence in the literature to suggest the most~     effective treatment. There is some evidence suggesting that compression therapy and manual~     lymphatic drainage can improve lymphedema but more studies are needed. The aim of this~     research is to to evaluate the clinical effect of multimodal treatment (compression~     bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with~     arm lymphedema after breast cancer surgery.~   "
68249|NCT02163993|"~     The main purpose of this study is to evaluate whether the study drug known as LY2951742 is~     safe and effective in the prevention of migraine headaches. The study will last between 28~     and 36 weeks.~   "
68250|NCT02163980|"~     The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX)~     added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.~   "
68135|NCT02165683|"~     This is a single-arm, open-label study to assess the safety and effectiveness of a single~     dose of oral propranolol in reducing18F-fluorodeoxyglucose (FDG) uptake in brown adipose~     tissue (BAT) in pediatric oncology patients. This study is designed to better understand if~     taking a single dose of an oral medication called propranolol can reduce the chance of brown~     fat showing up on a PET scan, and therefore make the scan more accurate and easy to~     interpret. All humans have some degree of normal brown fat (called brown adipose tissue),~     and this normal tissue can sometimes light up on a PET scan. That creates problems because~     it may be wrongly interpreted by the radiologist as tumor, or it may hide true areas of~     tumor underneath it. Participants will not be randomized and will receive a single dose of~     oral propranolol approximately 60 minutes prior to the injection of the FDG tracer. The dose~     of propranolol will be 20 mg for all participants.~   "
68136|NCT02165670|"~     BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from~     2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with~     follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of~     the national SWEDEHEART registry).~   "
68137|NCT02165657|"~     The overall aims for this study are to determine whether UVB excimer laser treatment of~     psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema~     with excimer laser treatment.~      The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm~     excimer laser will decrease the levels of serum inflammatory markers. The investigators~     hypothesize that treatment will decrease plaque erythema and will result in minimal~     hyperpigmentation.~   "
68138|NCT02165644|"~     Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm.~     SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of~     non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths.~     Mortality can be 50% in the first few years of aneurysmal SAH rupture, 15% are severely~     disabled post SAH and only 20-35% having a moderate to good recovery it has gained lot of~     attention and pre-clinical and clinical trials of various agents have been tried to prevent~     poor outcome. The United States epidemiology data reveals the fact that 1% to 5% of adults~     have unruptured brain aneurysm and 30,000 people suffer from aneurysm rupture annually~     translating to brain aneurysm rupture every 18 minutes.~      Vasospasm is the most common SAH complication post 24 hours. It is the segmental or diffuse~     narrowing of the vessels especially the large vessels. Fifty percent of those patients who~     develop clinical vasospasm, progress to infarction and 15-20% will advance to disabling~     stroke or die of cerebral ischemia. The present treatment modalities are insufficient to~     prevent vasospasm. So, we need new treatment modalities to decrease the mortality and~     morbidity in SAH patients.~      The investigators hypothesize that Acetazolamide administration can prevent development of~     vasospasm after aneurysmal SAH.~   "
68139|NCT02165631|"~     The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease~     in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and~     nocturnal periods. The primary aim of this study will be to determine the effects of~     Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to~     compare these to those of timolol.~   "
68140|NCT02165618|"~     Polypharmacy is a common problem in elderly, leading among others to increased adverse drug~     events. The aim of this pilot study was to evaluate whether a systematic medication~     evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on~     admission by an adjusted STOPP*-list in older patients) list could reduce inappropriate~     prescribing for elderly admitted patients, admitted to non-geriatric departments.~      (* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)~   "
68141|NCT02165605|"~     This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness~     and safety of HylaCareTM. The study will employ the patient as her own control, a commonly~     used method for the evaluation of topical dermatologic agents. Each patient will be~     randomized blindly as to whether the study serum will be applied to the medial or lateral~     portion of the treated breast, using the nipple as the dividing line. The product and~     placebo will also be applied to the contra-lateral breast in the same fashion, as a further~     control. The study drug and placebo will be applied three (3) times daily.~   "
68142|NCT02165592|"~     Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region~     of Murcia.~        -  Describe the periarticular muscular deficit of the lower limbs, depending on the degree~          of injury: acute and chronic, or subacute.~        -  Identify the range of motion of joints with higher prevalence of hemophilic~          arthropathy.~        -  Detect the biomechanical changes of the lower limbs and their impact on gait in~          patients with hemophilia.~        -  Assess the factors that influence the perception of illness and quality of life of~          patients with hemophilia.~   "
68143|NCT02165579|"~     The investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic~     foot infection in order to compare serial bone biopsies (the current gold standard) and~     procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. The~     investigator will collect specimens as part of an existing trial to evaluate negative~     pressure wound therapy in diabetic infected wounds. A high proportion of these patients have~     osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral~     antibiotics. The investigator expects repeated measurement of procalcitonin will be highly~     correlated with repeated bone biopsy after antibiotic treatment has been completed to~     determine if therapy has been successful or if additional antibiotic therapy is needed.~   "
68144|NCT02165566|"~     Insulin preparation -random assignment to regular insulin lin or lispro insulin as first~     treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients~     presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose~     concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction~     in blood glucose concentration after discontinuation of insulin infusion was recorded~     (post-infusional blood glucose concentration drop). During the study period blood glucose~     concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was~     allowed between the 2 treatments.~   "
69400|NCT02148952|"~     The purpose of this study is to measure the impact of a checklist-based childbirth safety~     program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal,~     and newborn harm in institutional deliveries in north India.~   "
68145|NCT02165553|"~     Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a~     cold or hot drink and is available in the United Kingdom (UK) markets in different forms~     including tea bags. There is preliminary data that support the hypothesis that HSC extract~     consumption has beneficial effect on blood vessel health and blood pressure reduction.~     Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key~     modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death~     throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the~     effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa~     calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels~     function will be investigated after a high - fat mixed meal. This is with a view to~     determining the impacts of the extract on postprandial (after meal) blood pressure and other~     CVD risk factors. Results from the PHYTOVAS study could lead to identification of more~     dietary approaches that will contribute to CVD risk prevention and management.~   "
68146|NCT02165540|"~     The purpose of the study is to examine the impact of doula support for women undergoing a~     manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.~   "
68147|NCT02165527|"~     The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer~     software program can make accurate measurements of the length of leg bones compared to~     conventional x-rays.~   "
68148|NCT02165514|"~     Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar~     iDXA x-ray scan.~   "
68149|NCT02165501|"~     Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis~     management are recognized. Investigators present a population-based registry with easy~     feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of~     the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or~     septic shock). Baseline data on ICU- and hospital care will be extracted from patient~     records at ICU discharge. The primary outcome is change in all-cause mortality from baseline~     to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data~     will be collected from the primary care provider of the patient. The registry may provide~     valid data on quality in sepsis care.~   "
68150|NCT02165488|"~     0% of ketamine users complain of abdominal discomfort. Long-term ketamine use is associated~     with hepatotoxicity and pathologic changes to the biliary tract. Yet the prevalence of~     gastrointestinal and hepatobiliary pathologies in ketamine users has not been~     well-described. The investigators plan to recruit a large number of ketamine users based on~     referrals from different Psychiatry clusters in Hong Kong and to investigate the underlying~     cause of abdominal discomfort, describe the prevalence of different gastrointestinal and~     hepatobiliary pathologies and describe their long-term outcome.~   "
68151|NCT02165475|"~     Background: Biofeedback and medical treatments have been extensively used for moderate fecal~     incontinence. There is limited data comparing and combining these two treatments.~      Aim: To evaluate the effect of biofeedback and medical treatments, separately and in~     combination.~      Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal~     incontinence were included. The patients were randomized to start with either biofeedback~     (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both~     groups continued with a combination treatments, i.e. medical treatment was added to~     biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal~     physiology were evaluated at baseline, after single- and combination treatments.~   "
68152|NCT02165462|"~     Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in~     patients with haemophilic arthropathy Describe the differences in terms of the physical~     variables (muscular strength, range of motion and proprioception) in patients with~     hemophilia who have conducted a home treatment with a digital tool.~      Bookmark the relationship between clinical history of joint bleeds and clinical~     manifestations in standing and walking.~   "
68153|NCT02165449|"~     The drug Ketamine, available in medical practice since the late 1960s, is currently used for~     inducing general anesthesia or sedation during medical procedures. When given slowly as an~     injection into a vein, ketamine is shown to produce a very rapid effect on depression and to~     improve depressive symptoms within hours to days. By studying patients who receive a~     ketamine IV infusion, as an add-on treatment for depression, investigators may start to~     understand how changes in the brain or in gene function relate to getting better over a very~     short period of time. In this study, the investigators will enroll 30 patients currently ill~     with major depression selected to receive IV ketamine therapy under medical supervision. To~     study neurobiological changes relating to symptom improvement, the investigators will use~     advanced brain scans to measure brain structure, chemistry and function. Blood samples will~     measure changes in gene regulation and immune system response. Although some people have a~     rapid antidepressant response to ketamine, others do not respond. Also, antidepressant~     effects after ketamine usually wear off within days to weeks. In 20 of the 30 patients~     enrolled in this trial, we will also determine if up to four doses of ketamine delivered two~     to three times a week may prolong antidepressant response to ketamine therapy. To determine~     the durability of ketamine treatment for depression, patients will be monitored by phone and~     via electronic devices twice a week for up to five weeks and will return for a final~     assessment when their symptoms return. For this trial, brain and blood sample measurements~     will occur before and at three time points (6 hours and 24-hours) after a patient receives~     their first ketamine infusion. Patients who do not remit after an initial dose of ketamine,~     will receive up to three additional ketamine treatments. Mood will be measured 24-hours~     after each subsequent ketamine infusion and brain and blood measurements be repeated at the~     time of remission or after the fourth ketamine infusion if remission does not occur.~     Patients will return for a final brain scan and blood sample when their depressive symptoms~     return or at five weeks if they continue remission. Investigators will able to see how~     changes brain measurements, gene regulation and immune response relate to improvements and~     relapse of depressive symptoms with ketamine IV therapy. The ketamine infusion sessions will~     occur at a special research unit (CTRC) at UCLA.~   "
68154|NCT02165436|"~     The purpose of this study is to evaluate the effectiveness of chewing gum on reducing~     post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric~     patients undergoing surgical correction of scoliosis. This study would provide minimal risk~     to its study population, and has the opportunity to provide a benefit to patients undergoing~     scoliosis surgery. If shown to be effective, this could lead to changes and improvement of~     the post-operative course for pediatric scoliosis patients.~   "
68155|NCT02165423|"~     The purpose of this study is to address a gap in knowledge needed for care of children with~     solid organ transplantation (SOT) and their parents by combining mHealth technology with an~     individualized family centered self-management intervention (referred to as myFAMI). This~     study is critical to the increased understanding of hospital to home transition and family~     management at home with the potential to transform the way clinicians approach the care of~     complex chronic illness children and families.~   "
68156|NCT02165410|"~     The purpose of this study is reproduce the individual detection results by PET with Arterial~     Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.~   "
68159|NCT02165371|"~     It has been established that children in families affected by either intimate partner~     violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are~     at substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan~     African context of high levels of HIV/AIDS and family violence, it is crucial that parents~     be supported to establish positive parenting practices and reduce harsh or abusive parenting~     within their families.This randomized controlled trial will be testing the Sinovuyo Caring~     Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for~     primary caregivers of children between 2 and 9 years old. Participants will not be~     restricted to biological parents and include primary caregivers of children between 2 and 9~     years old, who live in the same house as the child at least 4 nights per week. Participants~     will be recruited through systematic household sampling, liaising with Western Cape~     Department of Social Development and local community-based NGOs. Self-reporting~     questionnaires and qualitative observational assessment data for intervention and control~     groups will be collected at pre- and post-test evaluation as well as 12-month follow-up.~     Primary outcomes will include child behaviour problems, harsh and inconsistent parenting and~     positive parenting. Secondary outcomes will include parental depression, parental stress,~     parental monitoring and supervision and parent perceived social support.~   "
68160|NCT02165358|"~     The purpose of this study is to investigate the paradoxical muscle enlargement in the calves~     and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular~     dystrophy type 2I.~      The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle~     structure on MRI and based on a calculation of muscle strength per cross-sectional area.The~     findings will be compared with results from non-affected controls.~      Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.~   "
68161|NCT02165345|"~     This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118~     [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous~     (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile~     idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue~     to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to~     arthritis subtype and body weight. Participants will receive the treatment until commercial~     availability of the drug or for a maximum of 3 years, whichever is earlier.~   "
68162|NCT02165332|"~     This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses~     of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in~     healthy volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind,~     placebo-controlled study to determine the safety tolerability and pharmacokinetics of a~     supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8~     cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single~     dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way~     crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose~     of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by~     changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic~     parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated~     in Part 2.~   "
68163|NCT02165319|"~     To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped~     cuff~   "
68164|NCT02165306|"~     More than half of patients with epilepsy achieve full control of their seizures with~     antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational~     intervention in improving medication adherence in patients with epilepsy.~   "
68165|NCT02165293|"~     This single-center, open-label study will investigate RO7033877 concentrations in plasma and~     in various lung compartments, including epithelial lining fluid (ELF), and alveolar~     macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration.~     Bronchoscopy will be performed after the start of the last infusion on Day 3 at different~     timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine~     RO7033877 concentrations. The anticipated time on study treatment is 3 days.~   "
68166|NCT02165280|"~     We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery,~     have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after~     surgery compared to women who undergo our routine pre-operative care.~   "
68167|NCT02165267|"~     Antibodies are natural proteins that the body makes to fight infections. Antibodies can also~     be manufactured like a drug and infused or injected into the body to prevent or treat a~     disease. The purpose of this study is to test the safety of and the body's response to an~     antibody against HIV in healthy, HIV-uninfected adults.~   "
68168|NCT02165254|"~     The purpose of this study is to develop a tai-chi based exercise program designed for~     patients who recently had a heart attack and do not wish, or are unable, to attend~     traditional cardiac rehabilitation.~   "
68178|NCT02165124|"~     The purpose of this study is evaluate the safety and effectiveness of bariatric embolization~     as a minimally-invasive image-guided procedure for morbid obesity. In this procedure,~     specific blood vessels to the stomach are blocked in order to suppress some of the body's~     signals for feeling hungry, leading to weight loss.~      Morbid obesity is currently treated with diet and exercise, medications, and surgery. This~     study is designed to help treat obesity using a minimally invasive, non-surgical,~     angiographic (through the blood vessel) approach. This procedure is similar to a common~     procedure used to treat bleeding within the stomach. This version of the procedure has been~     named bariatric embolization.~      Although there are over 40 hormones that limit food intake, there is only one hormone,~     ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating~     fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and~     to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has~     been a target for the treatment of obesity and weight loss. More recently, ghrelin has been~     shown to have a significant role in the long-term effect of weight loss in bariatric~     (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated~     patients.~      Recent data collected in animals in has shown that blocking blood vessels to a particular~     portion of the stomach (bariatric embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5~     people, there was a decrease in ghrelin levels and weight loss in the first month after the~     procedure, but there is no information about the effects of the procedure over longer~     periods of time.~      We hope to learn if bariatric embolization results in safe and effective weight loss in~     people who are morbidly obese.~   "
68399|NCT02162017|"~     This study is an investigator-initiated and conducted, international collaborative,~     regionally organised, multicentre, prospective, cluster randomised, crossover, blinded~     outcome assessment study to compare the effectiveness of the lying flat (0°) head position~     with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for~     patients with acute stroke, on the poor outcome of death or disability over the subsequent~     90 days.~   "
68169|NCT02165241|"~     It is commonly known that heart failure (HF) is the main cause of mortality and morbidity~     which affects about 15 million people in the world and is the primary chronic cause of~     death. In spite of the development of pharmacological therapies which have led to a good~     control of the pathology, almost 50% of patients with advanced HF does not survive after the~     first year. Heart failure consists of a deterioration of the cardiac pump, whose performance~     become insufficient to satisfy the organism needs. HF can be the consequence of various~     pathologies, such as ischemia, chronic hypertension, valvulopathies, pericarditis, etc. In~     conditions of chronic overload, as the one induced by the cited pathologies, the~     cardiomyocytes reply with hypertrophy and/or death due to necrosis or apoptosis. At the same~     time, there is a collagen alteration which causes the substitution of the myocardial damaged~     portion with fibrotic material, increasing in this way cardiac rigidity and reducing~     contractility. Finally, the onset of inflammation, the activation of the immune system and~     of the inflammatory mediators affect heart functionality. These phenomena are regulated by a~     complex interaction between the cellular and molecular mechanisms, which moreover guarantee~     the homeostasis maintenance in physiological conditions. Nevertheless, their imbalance~     activates a complex series of events which have recently started to be recognized and~     studied. In effect, a recent work has underlined the importance of the splenic monocytes in~     the cardiac response to acute heart ischemia, changing our vision concerning the role of the~     immune system in heart diseases.Historically, the term cardiac remodeling had been~     introduced to describe the anatomical change of the heart which occurs after myocardial~     infarction. At a later stage, it has been acknowledged that also other pathological~     conditions, such as chronic hypertension, can be a cause of the myocardial remodeling.~     Physiologically, the immune system cells have always been considered for their role of~     protection from infections. Recently, instead, evidence have been showing that immune system~     cells might have far more complex functions in the heart. The myocardial remodeling comes~     from modifications that may be adaptive to the initial insult, but then this structural~     adjustment may become the activation of structural/metabolic circles which can potentially~     culminate in the transition to HF.~      This observational study will evaluate the immunological profile in relation to cardiac~     geometry variations in hypertensive patients. Aim of this project is to characterize the~     profile of immune system activation during the process of cardiac remodeling which is~     typical of the cardiomyopathy of overload. The main goal will be reached through the~     characterization of the circulating profile of immune system cells, in order to find a~     correlation with the clinical phenotype.~   "
68170|NCT02165228|"~     The long-term goal of the proposed research is to identify and develop effective~     interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a~     substantial contributor to inflammation, and interactions among stress, inflammation, body~     mass index, and health behaviors have been measured. Mindfulness-based stress reduction~     (MBSR) is effective for stress reduction, has been shown to be effective for inflammation~     reduction in individuals with disease, and is a sustainable practice for individuals across~     the health spectrum. Diet strategies are an effective means of reducing inflammation for~     some individuals, but may not be successful for many people, as evidenced by the steady rise~     in obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR~     compared to an established intervention of a nutrition enhancement (NE) intervention for the~     reduction of inflammation, and 2) test the effectiveness of MBSR compared to a~     non-intervention control conditions (CON) for the reduction of inflammation. Men and women~     25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or~     CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory~     cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles,~     anthropometrics, dietary intake, and all components of the metabolic syndrome will be~     measured pre- and post-intervention to elucidate underlying mechanisms and to determine~     whether health benefits beyond inflammation reduction occur.~   "
68171|NCT02165215|"~     This Phase III, randomized, double blind, parallel grouped, placebo-controlled, multicenter~     study will investigate the efficacy and safety of etrolizumab in maintenance of remission in~     participants with moderately to severely active ulcerative colitis (UC) who are naïve to TNF~     inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid~     treatment.~   "
68172|NCT02165202|"~     This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the~     safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight~     weeks over a 40 week period among sexually active, HIV- uninfected women.~   "
68173|NCT02165189|"~     The purpose of this study is to evaluate sustained virologic response 12 weeks after the end~     of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without~     ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic~     liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus~     (HCV) Genotype 1 infection.~   "
68174|NCT02165176|"~     Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of~     orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of~     oral cannabis dose effects on these parameters is required to determine the level and~     duration of biological cannabinoid exposure and associated subjective, cardiovascular and~     cognitive effects. The present study will evaluate the detection of cannabinoids in oral~     fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis~     (10mg, 25mg, or 50mg THC). In addition, we will conduct subjective, behavioral, and~     cognitive performance assessments to evaluate the time course of the consequences of oral~     cannabis ingestion among study participants. The outcomes of the study will extend~     scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis and~     can inform policies regarding clinical, workplace and roadside drug testing programs.~   "
68175|NCT02165163|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and~     gait) in cancer patients.~      The investigators hypothesize that the virtual reality-based balance training intervention~     will improve balance and gait performances in cancer patients compared to a control group~     receiving usual care only.~   "
68176|NCT02165150|"~     The goals of this research project are: 1) to develop and evaluate the safety and~     feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long~     term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional~     fitness and sleep quality of elderly residents in long term care facilities, and 3) to~     investigate the compliance of elderly residents with long-term SEB exercises.~   "
68177|NCT02165137|"~     Quality control and improvement project: Assessment and analysis of processes and outcome in~     trauma emergency room and major trauma patients at the Aarau trauma center (cantonal~     hospital) with regard to initial emergency management, hospital processes and short- and~     long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of~     processes and outcome pre- and post- project initiative. Benchmarking with the literature~     and by participation in the German and Swiss Trauma registry each.~   "
69184|NCT02151786|"~     The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and~     efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of~     administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to~     a large number of patients in daily medical practice.~   "
68179|NCT02165111|"~     This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of~     Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's~     syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in~     one randomly-selected hand, and the contralateral hand will be injected with sterile saline~     (placebo) to serve as a control.~      Study participants at the first study visit will complete study questionnaires, their hands~     will be assessed clinically for digital ulceration, and their hands will undergo~     non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the~     patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of~     sterile saline solution (placebo) in the other, in a randomized, blinded manner.~      Patient will report the severity of their Raynaud's symptoms weekly over the four month~     study period. At one month post-injection, the patient will complete study questionnaires,~     their hands will be assessed clinically for digital ulceration, and their hands will undergo~     non-invasive laser Doppler imaging. At four months post-injection, the patient will again~     complete study questionnaires, their hands will be assessed clinically for digital~     ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition,~     patient will be given the option of one week post-injection visit, at which point the same~     assessment will be performed.~      At the conclusion of the study, unblinding will occur.~   "
68180|NCT02165098|"~     The investigators are doing this study to compare blood levels and side effects of~     cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate~     release' capsule. The investigators will also find out if food affects the absorption of~     cariprazine into the bloodstream after a 'slow release' tablet.~   "
68181|NCT02165085|"~     The purpose of this study is to determine whether patients with vascular Ehlers-Danlos~     syndrome present significant and specific changes of arterial endothelial and smooth~     muscular cell signalling/secretion, in comparison to matched healthy volunteers and patients~     with spontaneous arterial dissections.~   "
68182|NCT02165072|"~     This is an observational study that will examine the possibility of determining the type of~     Acute Kidney Injury (AKI) using bedside ultrasound machines.~   "
68183|NCT02165059|"~     In this research study, biopsy samples will be collected to provide more insight into the~     underlying cause of the motility disorders, help direct further investigation into the cause~     of the underlying condition, provide future prognosis and predict response to gastric~     electrical stimulation (GES).~   "
68184|NCT02165046|"~     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and~     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway~     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly~     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is~     used as a bronchodilator in the management of reversible airways obstructive pulmonary~     disease. Budesonide and Procaterol therefore have complementary effects, treating two~     different components of asthma.~   "
68185|NCT02164825|"~     Single-shot femoral nerve block is similar to continuous epidural technique for~     postoperative analgesia in total knee arthroplasty~   "
68186|NCT02164812|"~     The purpose of this study is to determine whether multiple doses of Efavirenz has an effect~     on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.~   "
68187|NCT02164799|"~     The Shock Tool study is designed to improve the clinical evaluation for differentiating~     shock in the emergency department. The goal of this study is to evaluate and improve the~     accuracy of physicians differentiating causes of shock.~   "
68188|NCT02164786|"~     Acute severe disease is a major public health challenge that often affects young adults.In~     past decade, there are lot of new techniques have been developed that aim to improve the~     outcome of acute severe disease, But few of these works success. According to recently~     studies, the mortality of the multiple organ dysfunction syndrome（MODS) that is the major~     cause of death in patients who suffering from acute severe disease, is not improved. On the~     contrary, if MODS be predicted in early stage of acute severe disease, the death can be~     prevented. Because acute severe disease poses complex injury that involves multiple~     pathological processes, understanding the cellular and metabolic network malfunction during~     acute severe disease is crucial for clinical monitoring and intervention.~      Human metabolism is a complex network with hundreds of cross-linked paths. During critical~     illness, the metabolic network is dynamically disturbed at multiple points. Classical~     research typically isolates a small part of this network to investigate the impact of~     pathological physiology molecular mechanisms on clinical outcome. In particular, researchers~     have examined metabolic disturbances such as cytokine network dysfunction, skeletal muscle~     breakdown, insulin resistance, dyslipidemia, testosterone and growth hormone/Insulin like~     growth factor （IGF）dysfunctions, low thyroxine syndrome, and deficiency of vitamin D and~     calcium with secondary hyperparathyroidism. These complex metabolic disturbances appear and~     interact at different stages during the pathological process after acute severe illness.~     Therefore, an integrated approach that combines the biochemical/molecular changes with~     network disturbances is the key to understanding acute severe illness at the systems biology~     level and establishing an accurate quantitative model for clinical monitoring.~      An interdisciplinary method that includes high-throughput quantitative techniques and~     effective mathematical and visualization tools is necessary. Furthermore, interdisciplinary~     methods present the opportunity to develop innovative clinical diagnosis and monitoring~     methods for severe injuries. The aim of this study is to provide a novel high-throughput~     method that integrated proton-nuclear magnetic resonance (NMR) metabolomic fingerprinting~     and High Performance Liquid Chromatography with advance mathematics tools to modeling~     metabolic dynamics after acute severe disease.~   "
68189|NCT02164773|"~     Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The~     aim of the study is to delineate the effect of caudal magnesium sulfate in children~     undergoing lower abdominal surgery to prevent postoperative emergence agitation.~   "
68190|NCT02164760|"~     In this study the safety and feasibility of an acellular dermal template (Novomaix),~     combined with split thickness skin grafts, for use in patients with full thickness skin~     defects, is tested. Results will be compared intra-patient with those obtained after~     conventional treatment with split thickness skin grafts. We expect this treatment to be~     safe, and to provide better outcome regarding scar quality.~   "
68191|NCT02164747|"~     The purpose of this study is to determine whether teleconsulting would be effective and~     cost-effective by reducing the patients transportations and the use of emergency units for~     nursing home residents.~   "
68223|NCT02164331|"~     Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the~     Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly~     visits for hypertensive patients with uncontrolled blood pressure (BP) using a~     theoretically-informed, empirically grounded, multimodal quality improvement (QI)~     intervention.~      Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly~     visits.~      Aim 3: To assess potential mediators and moderators of the intervention.~   "
68192|NCT02164734|"~     In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via~     nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be~     randomized to standard delivery of surfactant via and endotracheal tube airway (inserted~     after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via~     laryngeal mask airway (LMA). The intent is to remove the airways and return babies to~     non-invasive CPAP support, after surfactant is given. The primary outcome measure is the~     rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a)~     early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal~     intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,~     retreatment with surfactant within 8 hours or more than 2 doses of surfactant.~      The objective of this protocol is to reduce the need for endotracheal intubation and~     mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by~     instilling surfactant though an LMA, while achieving comparable efficacy of surfactant~     treatment.~      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of~     babies with RDS who require mechanical ventilation or subsequent intubation, when compared~     to standard surfactant treatment following endotracheal intubation with sedation.~   "
68193|NCT02164721|"~     The purpose of this trial or study is to determine if cardiac resynchronization therapy~     (CRT) can be a benefit to people who have impaired heart function due to past treatment with~     chemotherapy and/or chest radiation. The investigators are looking to enroll approximately~     30 eligible subjects with heart failure in this trial. All patients enrolled and registered~     in the study will be implanted with a cardiac resynchronization therapy device that includes~     an implantable cardiac defibrillator (CRT-D). Clinical histories, physical exams, and~     external device testing will be collected both at the time of enrollment in the trial and~     during follow-up study visits. Following implantation of the CRT-D, patients will be~     contacted by phone at 3 months and will have a scheduled clinic visit follow-up at 6 months.~   "
68194|NCT02164708|"~     This paper extends prior research by exploring how students with self-critical (SC) traits~     respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety~     sensitivity and mood changes during the school year as students attended MM tutorials ii) to~     study the relationship between self-criticism and MM-related benefits over time. This paper~     reports on participants' mood and anxiety sensitivity changes before, during, and after the~     MM program and the association between depressed mood and SC levels. Participants were~     trained in MM over two continuous semesters, with two specific hypotheses guiding~     evaluations:~        1. Participants overall would report progressive improvements in psychological well-being~          as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of~          the MM program.~        2. Elevations in self-critical personality traits would predict greater improvements in~          depressed mood, given the greater need to neutralize cognitive events related to~          negative moods.~   "
68195|NCT02164695|"~     To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in~     patients with ST-segment elevation myocardial infarction treated with primary percutaneous~     coronary intervention (PPCI) within 12 hours of symptoms onset.~        -  Control group: PPCI only~        -  Study group: PPCI + RIPC~      Primary endpoint: Salvage index measured by contrast-enhanced cardiac magnetic resonance~     (CMR) at 3 to 5 days after index procedure~   "
68196|NCT02164682|"~     Hypospadias refers to a disease represented by a congenital defect in the urethra meatus~     (urinary opening) in male children. Due to the postoperative pain, symptoms such as~     discomfort, agitation, and restlessness are generally found. In particular, young children~     with restlessness often express their pain or discomfort with their bodies because they are~     unable to express it in words. This severe restlessness may make an operated region~     unstable, accompanying bleeding, infection, or other surgery-related complications. Because~     postoperative pain control is very important, neuraxial block techniques such as epidural~     block or caudal block have been employed in addition to a penile dorsal nerve block.~     Although the neuraxial block technique including the caudal block is an easy and safe method~     and has an excellent effect, the neuraxial block technique poses a potential risk in the~     procedure. In addition, with respect to the surgical prognosis, it has been reported that~     penile engorgement may cause penile vasodilation, resulting in oozing at the surgical region~     or other surgical complications. However, there has not been a report on the increase of~     postoperative complications by penile vasodilation or on the difference in the recovery or~     surgical prognosis according to the types of pain control for young patients.~   "
68197|NCT02164669|"~     Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the~     underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and~     biochemical indicators will be used to explore the underlying mechanisms and represent a~     promising precursory target for diagnosis and treatment of POCD.~   "
68198|NCT02164656|"~     The Mindfulness Training for Smokers Online Feasibility Study is a pilot study designed to~     test Mindfulness Training for Smokers in an Internet format with phone counseling.~   "
68199|NCT02164643|"~     A Multicenter national longitudinal cohort study including at least 800 individuals~     consecutively recruited from French Research Memory Centers and followed-up over 24 month~     and included in Memento.~   "
68200|NCT02164630|"~     The purpose of this study is to examine the effects of a hope-based intervention on clinical~     and experimental pain in individuals with temporomandibular disorder (TMD). To examine the~     effectiveness of this intervention, a two-arm randomized trial will be conducted with 50~     individuals, between the ages of 18 and 65, who have TMD.~   "
68201|NCT02164617|"~     The goals of this three-year research project were: 1) to develop and evaluate the~     feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented,~     wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects~     of the instructor-led WSEB on the functional fitness, daily life function, depression, and~     problem behaviors of this senior population, and 3) to test the feasibility, compliance, and~     effectiveness of the DVD-led WSEB on this senior population.~   "
68412|NCT02161848|"~     The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag~     muscles, thighs and calves in patients with the mitochondrial disease chronic progressive~     external ophthalmoplegia (CPEO).~      Additionally an investigation of the volume of the eye muscles will be done and compared to~     the patient's clinical presentation of ptosis and ophthalmoplegia.~   "
68202|NCT02164604|"~     Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born~     children, characterized by the development of retinal neovascularisation, macular dragging~     and eventually retinal detachment. ROP is a leading cause for childhood blindness,~     especially in developing countries. Vascular endothelial growth factor (VEGF) plays an~     important role in the development of the disease. Recently, the BEAT ROP study tested the~     efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled,~     randomized, stratified, multicenter trial. Authors found that bevacizumab showed a~     significant benefit for Zone I but not Zone II disease, with continuation of peripheral~     retinal vessel growths after treatment. The authors also concluded that safety could not be~     assessed due to the small sample size. Other authors raised concerns regarding the results~     of the BEAT ROP study and the safety of bevacizumab.~      The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus~     ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single~     injection of ranibizumab.~   "
68203|NCT02164591|"~     The purpose of this study is to determine the physiologic effects of temporary gastric~     electrical stimulation in subjects with severe gastroparesis.~   "
68204|NCT02164578|"~     Study to investigate microvascular and antiinflammatory effects of Rivaroxaban compared to~     low dose aspirin in type 2 diabetic patients.~      Especially patients with cardiovascular disease and subclinical inflammation are in the~     focus of interest.~   "
68205|NCT02164565|"~     The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur~     surgery.~   "
68206|NCT02164552|"~     The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS~     will improve insulin sensitivity and resistance and inflammatory response to PCOS.~   "
68207|NCT02164539|"~     The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium~     bromide in combination with fluticasone furoate compared with fluticasone furoate~     monotherapy in chronic obstructive pulmonary disease participants with an asthmatic~     component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to~     the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone~     furoate/vilanterol.~   "
68208|NCT02164526|"~     Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging~     society, chronic heart failure has become a global public health problem. Therefore the~     prevalence of pulmonary hypertension due to the left heart disease is increasing. However,~     there is no research on the prevalence of pulmonary hypertension due to the left heart~     disease in China. Therefore, the aim of the present study was to describe real-world outcome~     of Chinese patients with pulmonary hypertension due to the left heart disease and identify~     factors that may predict outcome. Our study will profile the demographics, clinical course,~     treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.~   "
68209|NCT02164513|"~     The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol~     (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with~     dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the~     use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic~     Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple~     inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health~     Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared~     to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety~     profile with dual or monotherapy doses for periods of up to one year. Given the clinical~     experience with FF, UMEC and VI, and that the associated risks with these compounds are~     anticipated from their known pharmacology, the potential benefit of a new therapy option in~     patients with moderate to severe COPD supports the further development of the closed triple~     combination (delivered via one inhaler). In the current study subjects meeting all~     inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period~     and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the~     following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once~     daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD~   "
68210|NCT02164500|"~     The Purpose of this trial is:~        -  to determine the overall response rate (ORR, complete response [CR] + partial response~          [PR]) in patients with relapsed or refractory HL~        -  to determine the safety profile of ruxolitinib in patients with relapsed or refractory~          HL~   "
68211|NCT02164487|"~     Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety~     of plants and microorganisms. Since animals usually cannot synthesis it, humans must be~     supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small-~     about 30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might~     occur when the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in~     energy metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the~     central and peripheral nervous systems as well as affecting the heart and gastrointestinal~     systems.~      Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in~     diet and recently secondary to anti-obesity surgery and few case reports described eating~     disorders as the reason for developing deficiency causing neuropathy, (1,2) and~     encephalopathy (3,4,5).~      One of the presentations of thiamine deficiency is peripheral neuropathy mimicking~     Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms.~      One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa~     patients (6) by measurement of the activation of the enzyme erythrocyte transketolase~     following addition of thiamin pyrophosphate and comparing them to control of blood donors.~     This study found significant lower levels of vitamin B1 in the anorectic patient compared to~     the controls.~      Rational of the study:~      The investigators assume that these few cases described of overt neurologic impairment due~     to vitamin B1 deficiency because of distorted eating are just the tip of the iceberg and~     more eating disorders patients lack thiamine, that may have neuropsychiatric effect on the~     illness and identifying and treating the shortage may improve the symptoms of the disorder~     and maybe even the distorted thoughts that are fundamental in eating disorders.~   "
68234|NCT02164188|"~     This protocol proposes a well-being program based on meditation and Positive Psychology~     principles such as human development, the improvement of virtues, quality of life and~     well-being. The investigators hypothesize that this program may promote well-being and~     reduce stress related problems in the participants. Objectives: To evaluate the efficacy of~     a well-being program in a sample of managers who work in a company (Natura~     Inovação/Cosméticos ) and health care professionals who work in a hospital (Hospital~     Israelita Albert Einstein) as well as its implication in the work environment. Methods:~     Sixty managers from Natura Inovação/Cosméticos and 60 health professionals from Hospital~     Israelita Albert Einstein will be recruited. The participants will be randomized in two~     groups of 30 participants each one, half of them in the control group (GC) and the other~     half to the intervention group (GI).~   "
68212|NCT02164474|"~     Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have~     been prescribed moderate-intensity continuous aerobic exercise but adherence to this~     standard exercise program is dismal. High-intensity interval training (HIIT) is a novel form~     of exercise that involves brief, repeated bursts of vigorous exercise separated by periods~     of recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to~     traditional exercise but does so with a lower amount of exercise and in substantially less~     time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a~     time-efficient exercise strategy for improving health. Whether overweight individuals at~     risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous~     exercise over the long-term (12-months) has not been tested. Because exercise adherence~     requires complex self-regulation, interventions designed to improve adherence should include~     a behavioural component. The investigators will assess adherence to HIIT and~     moderate-intensity continuous exercise over 12 months following a short-term (2 week)~     intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will~     include a self-regulatory component targeted to increase participants' confidence to engage~     in regular, independent exercise. The results will help determine whether HIIT is a more~     feasible option for promoting exercise adherence for pre diabetes prevention than the~     traditional moderate-intensity continuous exercise. The investigators hypothesize that a)~     over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere~     when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up~     subjects randomized to HIIT will have higher rates of adherence and levels of total physical~     activity, c) greater increases in self-regulation (including goal setting, self-monitoring,~     and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d)~     10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory~     fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve~     glucose control and e) Improvements in cardiometabolic health factors will be greater~     following HIIT compared to moderate-intensity continuous exercise.~   "
68213|NCT02164461|"~     To evaluate the tolerability and safety of ADXS11-001 (1 x 10^10 colony forming units [cfu])~     administered with prophylactic premedication in repeating 3-dose study cycles in women with~     persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or~     adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS,~     time to progression) by immune-related Response Evaluation Criteria in Solid Tumors~     (irRECIST).~   "
68214|NCT02164448|"~     The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate~     the hemodynamic instability and decrease in the splanchnic blood flow caused by~     pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of~     intraoperative dexmedetomidine infusion on postoperative bowel movement in patients~     undergoing laparoscopic gastrectomy.~   "
68215|NCT02164435|"~     This is a prospective, single centre clinical investigation looking at short (6 months) and~     long term (24 months) changes in cardiac function and renal function in patients with~     drug-resistant hypertension post renal sympathetic denervation.~   "
68216|NCT02164422|"~     Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize~     that guanfacine versus placebo will decrease the number of drinks consumed during the 2-hour~     self-administration period across stress and neutral/relaxing conditions.~   "
68217|NCT02164409|"~     This is a research study for patients who currently have or previously had an H. pylori~     infection and who plan to undergo an endoscopy as part of their care. The purpose of this~     study is to find out how and why H. pylori infections can cause progression to gastric~     cancer and if it's possible for intervention prior to this progression.~   "
68218|NCT02164396|"~     The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or~     persists after the continued usage or discontinuation of contact lenses or refitting with~     low coefficient of friction lenses.~   "
68219|NCT02164383|"~     The objective of this research is to determine whether smartphone games show promise for~     helping smokers increase their chances of quitting. The central hypothesis is that smokers~     who have access to smartphone games during their quit smoking attempt will smoke fewer~     cigarettes and report less craving than will smokers without such access.~   "
68220|NCT02164370|"~     Acid/base imbalances are not well understood in pre-eclamptics, and better tools are needed~     to allow a thorough and meaningful evaluation. Disorders of electrolytes and albumin are~     common findings [13, 14], and the impact of such disorders on acid-base homeostasis has~     increasingly been acknowledged [4, 15]. The purpose of this prospective case-control study~     is to evaluate acid-base status in 100 women with mild or severe pre-eclampsia and 25~     healthy controls by applying the Stewart Fencl's physicochemical acid-base model. We~     hypothesize that several simultaneous, and possibly offsetting, metabolic acid-base~     disorders will be identified and quantified, and that these may be useful to guide~     clinicians in their medical management and indication for delivery. Intermediate and~     long-term goals are to evaluate the ability of the Stewart Fencl's physicochemical acid-base~     model to guide fluid management and predict maternal and neonatal outcomes.~   "
68221|NCT02164357|"~     This study will compare two ways of treatment for acute ischemic stroke: an endovascular~     treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a~     first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT~     in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours~     after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed~     separately.~   "
68222|NCT02164344|"~     Combined antiretroviral therapy (cART)-treated patients have increased mortality and~     morbidity compared to age-matched seronegative individuals. This increased mortality and~     morbidity has been associated to immune activation that persists also in patients under cART~     even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients,~     irrespective of cART treatment, show higher levels of activated T cells, inflammatory~     monocytes and proinflammatory cytokines than seronegative individuals. Several putative~     causes of this residual inflammation have been proposed and include ongoing HIV replication~     at low levels, the presence of coinfections such as cytomegalovirus, and microbial~     translocation.~      None of these causes are mutually exclusive and understanding the degree to which of these~     three cause residual inflammation in cART-treated individuals will require novel therapeutic~     interventions aimed at alleviated each putative cause.~      In this longitudinal study we aim:~        1. to reduce microbial translocation induced inflammation in cART-treated individuals with~          supplementation of cART with the probiotics.~        2. to investigate the potential benefits of 24 weeks of probiotics supplementation on~          immune function and on immune activation status~      Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract~     microbiome with reducted levels of bifidobacteria and lactobacillus species with increased~     levels of potentially pathogenic proteobacteria species.~   "
68235|NCT02164175|"~     Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving~     Hemodialysis~   "
68413|NCT02161835|"~     Investigators aimed to investigate whether training can increase fitness levels in patients~     with myotonia, and thereby reduce the symptom of myotonia.~   "
68224|NCT02164318|"~     This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates~     of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring~     vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize~     a program of forearm exercise training, application of nitroglycerin ointment or both. Goals~     of this study are (A) to measure if recruited subjects can tolerate the intervention~     protocols, and determine if dependent variable measures, including surgery outcome, and~     measurement of physiologic and biologic markers, can be obtained; (B) To measure subject~     compliance and adherence rates for each of the intervention arms and testing visits; (C) To~     examine which intervention or combination of interventions demonstrates the strongest~     preliminary effects in order to estimate power for a pivotal intent to treat trial; and (D)~     explore group differences in clinical vascular markers and biologic markers in vein tissue.~   "
68225|NCT02164305|"~     Dynamic control of the rotator cuff muscles plays an important role in stabilizing the~     shoulder during motion. Impairment in the neuromuscular control of these muscles may to lead~     to injury and pain. Rehabilitation programs have moderate success in decreasing pain and~     improving shoulder function. While most of these programs target the rotator cuff, it is~     still unknown if they serve to improve the neuromuscular control of the rotator cuff~     muscles. The rehabilitation may induce neurological and physiologic changes in neuromuscular~     structures and thus alter the neuromuscular control of the entire shoulder complex.~     Kinematics and electromyographic (EMG) activities have been widely used to study~     neuromuscular control. However, corticospinal excitability, which has been widely examined~     in the patients with neurological disorders, provides a more detailed account of central~     control from the primary motor cortex through the spinal cord to the muscles. This~     assessment of neuromuscular control will serve to illuminate the ability of the shoulder~     muscles to handle the stress from activities such as overhead sports activities and carrying~     or lifting heavy objects. This approach could be used to help design efficient training~     program for athletes and effective rehabilitation program for patients with shoulder~     injuries. The purpose of the proposed study is to investigate the effect of exercise~     treatment effect on the proprioception, kinematics, EMG and corticospinal excitability of~     shoulder muscles, including the deltoid and rotator cuff muscles.~   "
68226|NCT02164292|"~     The possibility to achieve a curative resection in patients with liver malignancies is~     limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein~     ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a~     revolutionary strategy to achieve resectability by inducing a rapid and large FLR~     hypertrophy. However, the possibility of achieving a short-term hypertrophy and high~     resectability rates has been counteracted in most published series by an increased risk of~     morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS~     procedure in a single high-volume HPB center, with special emphasis in the safety and~     feasibility of this new 2-stage strategy. The aim of the present study was to assess the~     safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.~   "
68227|NCT02164279|"~     About 30 to 40% of patients suffering from type I diabetes are at risk of developing a~     diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease.~     Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset~     of DN. However, it is a late (because it permits to detect a renal disease already present),~     non-specific and low sensitive biomarker.~      Therefore the main objective of this study is to identify early urinary biomarkers~     predictive of DN in children with type I diabetes, before the appearance of a~     microalbuminuria.~   "
68228|NCT02164266|"~     This study is designed to investigate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in~     healthy volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated~     time on study treatment is two weeks.~   "
68229|NCT02164253|"~     The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of~     iron deferiprone, which would reduce the brain iron to limit the development of amyotrophic~     lateral sclerosis.~      It has been shown an excess of iron in the central nervous system carrying a sporadic ALS~     patients. Iron overload associated with a loss of motor neurons may explain the signs of the~     disease (atrophy).~      The investigators discuss the hypothesis that reducing excess iron, the investigators can~     reduce the loss of neurons and thus the progression of signs of the disease.~   "
68230|NCT02164240|"~     The purpose of this research study is to determine the safety and tolerability of sunitinib~     alternating with regorafenib in participants with advanced gastrointestinal stromal tumor~     GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed~     to control the disease. Additionally, this study seeks to determine the highest dose that~     can be given safely for this combination of drugs.~   "
68231|NCT02164227|"~     The effectiveness of breathing exercise on anxiety in women during the first period of~     labor.~   "
68232|NCT02164214|"~     TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the~     TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on~     target cell type, TWEAK triggers multiple cellular responses ranging from modulation of~     inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the~     first to describe pro-inflammatory effects of TWEAK during central nervous system~     inflammation. Various data support the possibility that TWEAK produced by synovial~     macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic~     arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF~     in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing~     anti-TNF autoantibodies referred as beneficial autoimmunity to pro-inflammatory mediators.~     In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory~     synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy.~     The role of TNF-alpha in the regulation of TWEAK expression remains unclear.~   "
68233|NCT02164201|"~     This is a prospective, multicenter, single-arm study designed to collect clinical data to~     support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic~     hemostasis following cardiovascular surgery.~      The overall objective of this clinical study is to collect clinical data supporting the~     safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis~     following cardiovascular surgery. This study is intended as a post-market surveillance~     (follow-up) study.~   "
68237|NCT02164149|"~     The quality of colon cancer surgery is highly debated these years since the mortality of the~     disease is not declining markedly. Surgery is the main treatment of colon cancer and during~     surgery it is very important for the surgeon to remove the tumour and all potential ways of~     tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along~     the tumour feeding artery the surgeon aims to cut the vessel as central as possible. This~     means that all of the tumour feeding artery should have been removed after surgery.~      In this study the investigators want to measure the length of the tumour feeding artery~     after surgery as a quality control of the surgery. The investigators hypothesize that the~     artery will be shorter than 5 mm.~      The investigators wish to CT scan all patients two days after colon cancer surgery and~     afterwards measure then length of the artery on the images. This study will not inflict with~     the normal routine for patient information and treatment.~   "
68238|NCT02164136|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic~     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary~     and sexual function disorder. However, 32%-44% patients still suffered from urinary and~     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).~      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of~     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the~     protection of urinary and sexual function of male mid-low rectal cancer patients. The~     results showed that L-PANP-TME significantly decreased incidence of urinary and sexual~     function disorder. In order to further confirm our early work, we design a randomized~     controlled clinical trial to compare differences in urinary and sexual function protection~     and long-term outcomes between L-PANP-TME and O-PANP-TME.~   "
68239|NCT02164123|"~     The purpose of this study is to determine whether passive accessory intervertebral~     mobilization applied to the fourth thoracic vertebra produces autonomic effects.~   "
68240|NCT02164110|"~     The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of~     Euvichol in Healthy Adults and Children.~   "
68241|NCT02164097|"~     This study will be with pediatric patients who have refractory/recurrent solid tumors. They~     will receive standard chemotherapy (ICE) and we are investigating if the addition of a new~     drug, ODSH, will help to increase the time of their platelet recovery after ICE~     chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in~     pediatric patients receiving ICE chemotherapy.~   "
68242|NCT02164084|"~     This study will identify how much (if any) drug is absorbed from the skin of subjects with~     acne vulgaris after topical application of SB204.~   "
68243|NCT02164071|"~     The elderly comprise the most prevalent population in oncology practice. The available~     evidence suggests that old patients are undertreated patients, mainly because of their~     advanced age, regardless of whether they are highly functional patients, they do not present~     co morbidities and could benefit from oncology therapies.~      Treatment planning must consider several health indices that are useful when it comes to~     detecting geriatric problems that could affect the patient's treatment experience. The~     complete comprehensive geriatric evaluation stands out as cornerstone among other validated~     tools that do not work as isolated instruments; however, its length and complexity may~     hinder its routine use in clinical practice for decision making.~      The purpose of this study is to validate a comprehensive health status assessment scale in~     elderly patients (≥65 years) with hematological malignancies that, while integrating the~     essential dimensions of geriatric assessment and, with the same precision as the currently~     available valid tools, is shorter and easier to apply, so it can be incorporated into the~     daily practice and that aids in clinical decision making objectively.~      If so, this information would help identify patients that could benefit from a specific~     oncology treatment, thus contributing to developing a targeted intervention plan and to~     optimizing the cancer results in this patient population.~   "
68244|NCT02164058|"~     The purpose of this study is to determine if a device known as the TandemHeart® System~     (TandemHeart) can help limit heart damage and reduce serious complications after a certain~     type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by~     evaluating the use of the TandemHeart system prior to a procedure called percutaneous~     coronary intervention (PCI)~   "
68245|NCT02164045|"~     The current food effect study is being performed to support a Phase 3 study with BMS 663068.~     Results from this study will inform whether patients in the upcoming Phase 3 study can be~     given the flexibility to dose BMS-663068 in the fasted state, if so desired.~   "
68246|NCT02164032|"~     Non-alcoholic fatty liver disease (NAFLD) is a common human liver pathology, closely~     associated with the obesity pandemic and insulin resistance. In the insulin resistant state~     the liver remains sensitive to pro-lipogenic signals of insulin, which further promote lipid~     accumulation. Secretion of very-low-density-lipoproteins (VLDL), the main carriers of~     triglycerides (TG) in the plasma, is the principal pathway for the liver to mobilize and~     dispose of lipids. Thus, hepatic TG export must not be too low in order to prevent~     steatosis. Our preliminary data from animal experiments suggest that enhanced brain insulin~     signaling promotes hepatic VLDL secretion, and reduces lipid accumulation in the liver. It~     remains to be tested whether other insulin sensitive tissues, such as the myocardium or the~     skeletal muscle, are also affected. In humans, neuropeptides, including insulin, can be~     delivered to the brain via an intranasal (IN) route of administration, without causing~     relevant systemic side effects.~      Therefore, we hypothesize that by enhancing brain insulin signaling using chronic IN insulin~     administration hepatic TG export increases and prohibits lipid accumulation in the liver and~     other insulin sensitive tissues, such as the myocardium and the skeletal muscle.~   "
68247|NCT02164019|"~     The purpose of this study is to look at two different types of surgeries regularly used for~     treating cancer that has spread to and weakened the thigh bone (femur). Because it is not~     known which of these surgeries is best, the investigators will compare the results of the~     two procedures. They are looking to see if differences exist (after surgery) in function,~     quality of life, pain control, and possible complications.~   "
68248|NCT02164006|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in~     combination with brentuximab vedotin in patients with hodgkin's lymphoma.~   "
68251|NCT02163967|"~     The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone.~     Healthy subjects will have three 20 minute sessions of CES stimulation, at three different~     intensities of stimulation, with each session occurring on a separate day. Effect on~     parasympathetic tone will determined by measuring high frequency heart rate variability~     before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which~     delivers a low dose alternating current a varying frequencies will be used for the~     stimulation.~   "
68252|NCT02163954|"~     Patients with severe chronic kidney disease or end stage renal disease (ESRD) on~     hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with~     normal renal function. Not enough study has been conducted about the antiplatelet effects of~     ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would~     achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on~     HD.~   "
68253|NCT02163941|"~     For individuals suffering from posttraumatic stress disorder (PTSD), the emotional numbing~     and isolation that are a core aspect of their suffering and consistently impedes remediation~     often remains after first-line treatments are administered. Few interventions have proven~     successful for enhancing the empathy and social connectedness that will ultimately allow~     patients to flourish, and the search for target therapies is made more difficult by the fact~     that very little is known about the underlying physiology of emotional numbing and social~     isolation. The proposed study is designed to (1) investigate the hormonal, neural and~     immunological biomarkers related to emotional numbing, and (2) test whether~     cognitively-based compassion training (CBCT), an intervention designed and proven to enhance~     empathy, will reduce emotional numbing and increase empathy and social connectedness in~     veterans. To this end, thirty medically healthy males diagnosed with PTSD who continue to~     report emotional numbing symptoms after prolonged exposure therapy will receive 8 weeks of~     training in CBCT. Prior to, and again after the training, the investigators will assess~     patients' levels of oxytocin, inflammation, and self-reported emotional numbing and social~     connectedness. The investigators will also assess their neural response during a video task~     that assesses their ability to accurately read others' emotions. The investigators~     hypothesize that oxytocin, neural activity, and inflammation will predict social numbing,~     isolation, and empathy, and also that CBCT will positively impact the social outcomes that~     will pave the way toward health and well-being.~   "
68254|NCT02163928|"~     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will~     use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and~     vegetables to increase SCS in medical students. This will be an observational, non-invasive~     study examining skin carotenoid levels over time in individuals who have increased their~     intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will~     be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per~     day over an eight week period of time. Students will self-select their fruits and vegetables~     from a given list and will receive supermarket gift cards to offset the cost of the~     increased food. Students will be asked to follow their usual diet for one week. Then~     increase their intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight~     weeks. Then return to their usual diet for 2 weeks. SCS scores will be taken at baseline and~     week 1. At the beginning of week 2, students will be asked to increase fruit and vegetable~     intake to 4-6 cups per day. SCS will be measured every two weeks during the 8-week~     intervention phase. Students will return to their usual diet for 2 weeks and SCS will be~     measured at the end of that 2-week period.~   "
68255|NCT02163915|"~     The purpose of this study is to characterize the safety and tolerability of TAK-137 when~     administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder~     (ADHD).~   "
68256|NCT02163902|"~     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of~     submental fat.~   "
68257|NCT02163889|"~     The objective of this study is to investigate T2Candida performance as a monitoring tool for~     post-therapy clearance of Candida compared to blood culture.~      This study will collect a T2clinical specimen and companion blood culture from patients who~     have exhibited a positive blood culture by gram stain for yeast, and who are receiving~     treatment with antifungal therapy.~   "
68258|NCT02163876|"~     This study will evaluate the safety and efficacy of human central nervous system stem cell~     transplantation into patients with traumatic injury in the cervical region of the spinal~     cord.~   "
68259|NCT02163863|"~     Primary purpose of the Mimics Study is to evaluate the safety and performance of the~     BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.~   "
68260|NCT02163850|"~     Prospective, randomized, unblinded, multi-center investigational study with enrollment at up~     to 45 investigational sites. The study is designed to compare the study device (Direct Flow~     Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial~     comparator (using approved Medtronic self-expanding bioprosthesis or Edwards~     balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic~     aortic stenosis. Subjects will be followed through the index procedure, hospital discharge,~     and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual~     follow-up at 2 through 5 years will be conducted and analyzed separately.~   "
68261|NCT02163837|"~     Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The~     purpose of our study is to assess sleep quality, quantity, sleep schemes and physical~     activity in patients suffering from HE, before and after a 2 weeks treatment with~     rifaximine, which is currently given to lower blood ammoniac levels.~   "
68262|NCT02163824|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121~     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.~     The efficacy and safety of two different concentrations and two different dosing regimens of~     KPI-121 are also being assessed.~   "
68315|NCT02163122|"~     This is a pilot trial in cat allergic participants, designed to compare allergic responses~     in each participant to a specific allergen by two methods of exposure. The methods of~     exposure to be used are: the environment exposure chamber (EEC) and nasal allergen challenge~     (NAC). Potential participants will be screened for evidence of cat allergy.~      Participants with a range of allergic sensitivities to cat allergen will be enrolled. To~     help ensure some breadth in the level of allergic sensitivity among participants,~     individuals with both high and low exposures to cat allergens in their daily lives will be~     enrolled.~   "
68263|NCT02163811|"~     Lower extremity amputations are a significant cause of morbidity, mortality, loss of~     function and reduced quality of life. Self-management (defined as the process by which an~     individual adopts an active role in managing the symptoms, treatment, consequences, and~     lifestyle changes inherent in living with a chronic condition) is an important mechanism for~     improving health and reducing disability. This study will evaluate a 5-week group-based~     self-management intervention for Veterans with lower extremity limb loss (VETPALS) and~     determine its impact upon physical and psychosocial functioning, patient activation,~     self-efficacy, problem solving, quality of life and positive affect. This study represents~     one of the only prospective randomized controlled trials of a behavioral intervention for~     individuals with limb loss. It is expected that results will be used to inform the~     integration of self-management interventions into the VA Amputation System of Care. The~     specific primary hypotheses are:~        1. Individuals randomized to VETPALS will display greater improvements from baseline in~          physical functioning as measured by the MFA-SF than Veterans in the individual~          education support condition post-intervention and at a 6 month follow-up.~        2. Individuals randomized to VETPALS will display greater improvements from baseline in~          psychosocial functioning as measured by the PHQ-9 than Veterans in the individual~          education support condition post-intervention and at a 6 month follow-up.~   "
68264|NCT02163798|"~     Cardiovascular diseases (CVD) accounted for major mortality and morbidity rates in Hong Kong~     (HK) other than cancer. Increasing energy expenditure through regular exercise participation~     has been found to lower the risk of CVD such as hyperlipidemia and obesity. Healthcare~     professionals often prescribe lifestyle exercises for disease prevention, rehabilitation,~     and health maintenance purposes. Previous study revealed that Tai Chi and walking were~     widely practice by HK citizens. However, limited studies are found to compare the health~     benefits between Tai Chi and walking. Do Tai Chi and walking have equally effective in~     raising metabolic rate and reducing CVD risks? The difference in energy cost between a~     single bout of Tai Chi and walking has not been documented. Limited studies report the~     effects of Tai Chi in lowering the CVD risk. Since walking and Tai Chi are being heavily~     promoted in HK in recent years, there is an urgent need to document the evidence of these~     two common forms of exercise in terms of reducing CVD risks. Therefore, the purpose of the~     present study was to investigate the energy costs as well as CV health benefits, in terms of~     aerobic fitness, body composition, blood pressure, and blood lipid profiles, from the~     walking and Tai Chi exercise in a sample of HK Chinese adults, and to compare the effects~     between these two exercises. The investigators hypothesized that Tai Chi and walking had~     similar effects on improving energy cost and reducing CVD risks.~   "
68265|NCT02163785|"~     Prospective multicenter randomized controlled trial comparing the prone vs. the supine~     position of the perineal time of the Miles operation in patients with advanced rectal~     cancer.~      Primary objective:~      - Pathological circumferential resection margin~      Secondary objectives:~        -  5 year oncological outcomes~        -  Morbimortality rates~        -  Surgical specimen quality~        -  Perineal hernia incidence~   "
68266|NCT02163772|"~     Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN)~     injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes.~     Although the long term treatment effect is encouraged, the point when to perform surgical~     treatment is not conclusive. Previous reports suggested late treatment principle because~     patients may spontaneous reinnervation to some degree within 4-5 months after injury. The~     vocal cord position and tone may change during reinnervation. Others delineated laryngeal~     synkinesis by misdirected reinnervation is common and suggested early temporary injection~     laryngoplasty. They implied early injection laryngoplasty may improve patients'not only~     short term voice outcomes but also decrease the incidence of transcervical laryngeal~     framework surgery as a determined surgery. However, lacking of prospective study and~     objective data makes the treatment-time policy still controversial. Purposes: 1. To find~     incidence of spontaneous reinnervation or synkinetic regeneration. 2. To detect the~     relationship between changing of glottal gap and laryngeal synkinesis. 3. To detect the~     impaction of early intracordal hyaluronic acid injection on vocal cord position change in~     patients with laryngeal synkinesis. Study design: Forty patients is planned to be enrolled~     in the study. Twenty of them will undergo hyaluronate intracordal injection at three-six~     month from RLN damage. The other 20 patients will follow the watch-and wait policy.~     Laryngoscope, laryngeal EMG (electromyography), voice analysis and voice outcome survey will~     be done at 3-6 month and 12-month after RLN injury. At the end of follow up, the glottal~     gap, voice laboratory data and quality of life will be compared. The outcomes will also be~     correlated with laryngeal electromyography (LEMG) data and the impact of synkinetic~     reinnervation.~   "
68267|NCT02163759|"~     This Phase III, double blind, placebo and active comparator controlled, multicenter study~     will investigate the efficacy and safety of etrolizumab in induction of remission in~     participants with moderately to severely active UC who are naïve to TNF inhibitors and~     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.~   "
68268|NCT02163746|"~     This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa:~     carbon dioxide (CO2) laser excision versus surgical deroofing.~   "
68269|NCT02163733|"~     This is a 2-part study in patients with epidermal growth factor receptor mutation positive~     (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with~     an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will~     determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow~     patients further access to AZD9291 and will provide for additional safety data collection.~      Part A is a randomised, open-label, 2 treatment period crossover study in which patients~     will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time~     (approximately 0800) in each of 2 treatment periods (once immediately following a high fat~     meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between~     doses.~      Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable~     patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2~     [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30~     evaluable patients.~   "
68270|NCT02163720|"~     The French cooperative group GINECO proposes to implement an observational study to describe~     a real situation, in daily practice tolerance and methods of administration of trabectedin~     (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer~     relapse.~   "
68335|NCT02162862|"~     The purpose of this study is to determine if either a targeted type of talk therapy (Phase~     I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in~     individuals with Inflammatory Bowel Disease (IBD).~   "
68336|NCT02162849|"~     The goal of this clinical research study is learn if varenicline or the nicotine patch can~     help people with different types of emotion and attention levels to quit smoking.~   "
68271|NCT02163707|"~     Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species~     of mushrooms, collectively known as psilocybin mushrooms. Psilocybin~     (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first~     isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is~     to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The~     study is performed in support of Phase II and Phase III studies of psilocybin for the~     treatment of refractory anxiety associated with incurable cancer, as well as other possible~     indications. Psilocybin is at present not an FDA-approved drug.~   "
68272|NCT02163694|"~     The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in~     combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced,~     unresectable, BRCA-associated breast cancer.~   "
68273|NCT02163681|"~     The purpose of this study is to develop rapid MRI techniques for imaging the lung with~     hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted~     in adults and older children before testing them in younger children and infants. The~     purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.~   "
68274|NCT02163668|"~     This study examined the effects of 8 months of Yoga training on bone density and bone~     turnover markers in premenopausal women, ages 35-50 years. The style of Yoga used was power~     Yoga that involved postures with a jumping component. The investigators hypothesized that~     the Yoga intervention would result in beneficial improvements in bone turnover markers, by~     increasing the bone formation marker and decreasing the bone resorption marker.~   "
68275|NCT02163655|"~     The purpose of this study is to determine if furosemide administered after the first 24~     hours of delivery, in women with severe peeclampsia and eclampsia accelerates high blood~     pressure control and diminishes hospital stay.~   "
68276|NCT02163642|"~     The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial~     peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis,~     which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB);~     and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds~     (VOC) for patients with non-CF bronchiectasis colonized by PPB.~   "
68277|NCT02163629|"~     In spite of major medical advances in heart transplant patients, psychiatric comorbidity~     remains very high in pre-and post-transplant phases. Anxiety and depression are especially~     frequent. They impact significantly morbidity and mortality. Especially because they are~     associated with poor therapeutic adherence and risks of infection and rejection. The~     inability to make beneficial therapeutic choice can be explained by the negative perception~     of events, associated with anxio-depressive disorders. This results in an important~     deterioration in quality of life of patients.~      The investigators assume that better management of emotions might reduce the stress of~     waiting situation and its psychopathological and somatic consequences pre-and~     post-transplant.~   "
68278|NCT02163616|"~     This study seeks to assess whether populations of women in Latin America outside Quito,~     Ecuador are at increased risk for developing elevated body temperature above 40.0°C~     following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in~     hospitals representative of different regions of Latin America to explore environmental and~     genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood~     loss, pulse and blood pressure will be systematically measured for all women enrolled to~     explore new clinical indicators for identifying women who require clinical intervention for~     excessive bleeding. Blood samples will be collected among women treated with misoprostol to~     investigate genetic factors responsible for elevated body temperature induced by~     misoprostol.~      The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol~     treatment (800mcg given sublingually) will be variable across settings. The investigators~     expect that the side effect profile following 800 mcg misoprostol given sublingually, in~     particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous~     results using misoprostol for PPH.~   "
68279|NCT02163603|"~     Developmental dislocation of the hip is a common disease in children, and its incidence in~     China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation~     and residual deformity and other complications are relatively common after treatment. The~     X-ray appears great acetabular index and wide medial gap , small central-edge angle. As~     there is no effective methods for treating such complications , investigators conducted this~     trial to find and prove optimal intervention time and treatment programs.~   "
68280|NCT02163590|"~     Passive mobilizations of the spine are widely used by physiotherapists in the management of~     neuromusculoskeletal disorders.~      There is a nascent body of work of the mechanical properties of joint mobilizations.~     Treatment dose is characterized by the direction of force applied, magnitude of force~     applied, frequency of oscillation, amplitude of displacement, repetition and time. Although~     the choice of better treatment dose is based on patient complaints and clinical reasoning,~     the comprehension of the effects of different parameters of joint mobilization will improve~     the decision making process. The optimal dose of treatment, however, is not already known.~      The primary aim of this study is to determine whether different rates of thoracic~     mobilization are capable to produces hypoalgesic effects, and secondarily investigate if~     such effects are local or widespread.~   "
68281|NCT02163577|"~     UX023-CL201 is a randomized, multicenter, open-label, dose finding, Phase 2 study. The study~     will be conducted in prepubescent children aged 5-12 years with XLH to assess the~     pharmacodynamics and safety of KRN23 administered via subcutaneous injections monthly (every~     4 weeks) or biweekly (every 2 weeks) for a total of 64 weeks. The study consists of a~     16-week individual dose Titration Period, followed by a 48-week Treatment Period. The study~     will enroll approximately 50 pediatric patients with XLH and radiographic evidence of bone~     disease. Subjects will need to discontinue oral phosphate and vitamin D metabolite therapy~     prior to randomization and throughout the duration of the study.~   "
68337|NCT02162836|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in~     Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate~     cancer that is resistant to medical [for example. hormonal] or surgical treatments).~   "
69549|NCT02147015|"~     The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD),~     personalized variable dose glucocorticoid treatment will result in superior clinical outcome~     when compared to fixed or experiential dose therapy.~   "
68282|NCT02163564|"~     Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90%~     of those adolescents have insomnia. If left untreated, insomnia increases the risk of~     relapse and recurrence of depressive episodes, unintentional injuries, poor school~     performance, substance use, obesity, and the risk for suicide. This project seeks to develop~     a nonpharmacological treatment for insomnia in adolescents with depression that is feasible~     and effective. The specific methodologies that will help accomplish these results are: 1)~     use of focus groups of adolescents with depression and insomnia to determine how the current~     standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for~     insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2)~     determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in~     adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This~     project will help to improve the quality and scope of delivery of mental health services in~     Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate~     depression in adolescents and b) to provide mental health professionals with a~     nonpharmacological treatment option for insomnia in adolescents with depression.~   "
68283|NCT02163551|"~     Dyspnea is a subjective experience of breathing discomfort that consists of qualitatively~     distinct sensations that vary in intensity. It is known that sensory information from the~     respiratory system activates regions of the cerebral cortex to produce the perception of~     dyspnea but far less is known about the neurophysiology of dyspnea than about vision,~     hearing, or even pain. Dyspnea likely arises from multiple nervous system sources, but the~     exact locations have not been well identified. Investigations of the mechanisms underlying~     respiratory sensations have included studies of airway anesthesia, chest wall strapping,~     exercise, heart-lung transplantation, hyperventilation, and opioid use. Study of the~     perception of breathing sensations in individuals with a spinal cord injury presents~     additional opportunity. The goal of the proposed project is to examine the effects of~     increasingly severe levels of spinal cord injury on the perception of breathing sensations~     in participants who are able to breathe without the use of a ventilator. The investigators~     hypothesize that the perception of breathing varies with the extent of somatosensory~     information that reaches cerebral cortex.~   "
68284|NCT02163538|"~     This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index)~     ergonomic assessment tool to detect differences in surgeon workload when using commercially~     available advanced bipolar devices. It is anticipated that the raw-TLX version of the~     validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the~     procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also~     positively impact other variables such as blood loss, operative time and cost.~   "
68285|NCT02163525|"~     This Post Market study is being conducted to compare the direct and indirect cost of three~     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of~     symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the~     requirements of the United States Food and Drug Administration's 522 (post market~     surveillance) order.~   "
68286|NCT02163512|"~     Multicentric, observational and prospective study with two groups of treatment: Refractory~     ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic~     blockers as primary or secondary profilaxis for variceal bleeding.~   "
68287|NCT02163499|"~     The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed~     with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance~     Phase.~   "
68288|NCT02163486|"~     Airway management is one of the basic topics in anesthetic practice. Use of endotracheal~     intubation and face mask are standard methods to maintain an open airway widely adopted for~     many years. As a result of a search for more appropriate choices from the point of view of~     effectiveness, reliability and side effects, supraglottic airway devices (SGAD) have been~     developed.~      SGAD's are used for thyroid surgery, ear surgery, carotid endarterectomy, adenotonsillectomy~     and laser pharyngoplasty, which require a variety of head-neck positions. Changing the head~     and neck position leads to changes in the shape of the pharynx, which causes variation in~     the cuff pressure and oropharyngeal leak pressure. Oropharyngeal leak pressure values play a~     determining role in protecting the airway from high cuff pressure. Additionally it shows~     that the laryngeal mask is correctly placed and is a sign of the effectiveness of positive~     pressure ventilation. During surgery head-neck and trunk position may change. As a result~     there is a need for research evaluating the effect of head and neck position on~     oropharyngeal leak pressure during SGAD use.~      AIM~      The aim of this study is to compare the effect of different head and neck positions on the~     oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Additionally the placement~     duration, ease and success of these two supraglottic airway devices will be compared.~   "
68289|NCT02163473|"~     The purpose of this research study is to determine if a chemical marker in the blood,~     hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes~     when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of~     pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most~     significant challenges in critical care medicine. The investigators propose that~     hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of~     Sepsis and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.~   "
68290|NCT02163460|"~     The aim of this study was to perform a randomised clinical trial comparing the use of~     closed-suction tubular drains and progressive tension sutures in individuals with large~     incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and~     surgical wound infection after surgery.~   "
68314|NCT02163148|"~     Anxiety disorders are common and impairing. Although exposure therapy is one of the most~     effective treatments for anxiety, some individuals do not fully respond to treatment, and~     these individual differences are not well understood. Exposure therapy involves repeated,~     deliberate, safe engagement with a feared stimulus without the feared outcome occurring.~     This treatment is thought to work through a type of emotional learning called fear~     extinction. This study aims to look at links between fear extinction learning and exposure~     success, with the overall goal of better understanding who is likely to respond best to~     exposure therapy and why.~   "
78277|NCT02032797|"~     The aim of the study is to determine whether 5 or 7 days of progesterone supplementation~     before transfer of a day 5 cryopreserved thawed embryos in an artificial cycle results in a~     significant higher pregnancy rate.~   "
68291|NCT02163447|"~     This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected~     pregnant women and the children born to them. The study interventions will be divided into~     two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be~     randomized in equal proportions to one of three intermittent preventive therapy in pregnancy~     (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of~     dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will~     have either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the~     pregnant women will end approximately 6 weeks after giving birth. In the second phase of the~     study, all children born to mothers enrolled in the study will be followed from birth until~     they reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP~     during pregnancy will receive DP every 3 months between 2-24 months of age. Children born to~     mothers randomized to receive 3 doses of DP or monthly DP during pregnancy will receive~     either DP every 3 months or monthly DP between 2-24 months of age. To ensure adequate~     blinding, children who will receive DP every 3 months will be given DP placebo during the~     months they will not be taking DP. Children will then be followed an additional year between~     24-36 months of age following the interventions. We will test the hypothesis that IPT with~     DP will significantly reduce the burden of malaria in pregnancy and infancy and improve the~     development of naturally acquired antimalarial immunity.~   "
68292|NCT02163434|"~     The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2~     weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded~     trial. After completion of the 2-week double-blind phase, subjects will be offered~     open-label gabapentin with rescue metoclopramide until their symptoms no longer require~     treatment. Enrollment will occur at the University at Buffalo and the University of~     Rochester.~   "
68293|NCT02163421|"~     The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of~     vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.~   "
68294|NCT02163408|"~     This is a technical development study with the goal to develop 3D techniques for~     atherosclerosis plaque characterization. We hypothesize that 3D MRI is superior to 2D MRI in~     characterizing major plaque constituents that contribute to severe clinical events such as~     myocardial infarction or stroke. The major advantages of the 3D techniques to be developed~     will include high spatial resolution, reduced scan times, and optimized image contrast. The~     use of contrast injection is not needed with the new techniques, which is greatly beneficial~     for patients with advanced chronic kidney disease.This is not a funded clinical trial.~   "
68295|NCT02163395|"~     -  Straumann Monotype FullCeram implants serve as a suitable alternative for implant~          therapy especially in the aesthetic zone~        -  The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant~          losses out of 40 patients) after the first year~   "
68296|NCT02163382|"~     Mechanical ventilation permits to support the work of breathing in case of respiratory~     failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which~     delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these~     complications. However, NIV is not always successful and half of children in respiratory~     failure finally require invasive ventilation. A major cause of NIV failure is the ventilator~     inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted~     ventilatory assist) improves the detection of patient efforts during mechanical ventilation.~     The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and~     therefore permits to unload the patient ventilatory efforts.~   "
68297|NCT02163369|"~     The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to~     medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness~     to relieve symptoms of nausea or vomiting and/or anxiety.~      Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety.~     This study will involve administration of aromatherapy to a convenience sample of patients,~     who will then be asked to complete a brief questionnaire. The questionnaire will involve a~     simple likert scale to measure efficacy (in the opinion of the patient) and simple~     multiple-choice questions to determine patients' likeliness to use aromatherapy again.~   "
68298|NCT02163356|"~     Currently there is no known effective treatment for recurrent or resistant neuroblastoma.~     Fenretinide is an anticancer agent that may work differently than standard chemotherapy. It~     may cause the buildup of wax-like substances in cancer cells called ceramides. In laboratory~     studies, it was found that if too much ceramide builds up in the neuroblastoma cells, they~     die.~      Fenretinide has been given by mouth as a capsule to many people, including children. When~     Fenretinide is given in capsules, very little of the drug is absorbed through the intestines~     into the body. This means patients have to take many capsules of fenretinide by mouth~     several times a day. In this study, a new oral preparation of fenretinide (called 4-HPR/LXS~     oral powder) is being tested to see if more fenretinide can be absorbed into the body.~     4-HPR/LXS oral powder has been tested previously in a limited number of both children and~     adult cancer patients.~      Ketoconazole, commonly used to treat fungus infections, can increase fenretinide levels in~     the body by interfering with the body's ability to break down fenretinide. Ketoconazole will~     be given at the same time as the fenretinide powder.~      There is preclinical data that shows that combining fenretinide and vincristine prolonged~     survival in animal models, therefore, it is hoped that giving the vincristine with~     fenretinide will work better against the neuroblastoma that either drug given alone.~      About 70 children with neuroblastoma have been treated with various versions of the~     fenretinide powder to date, including about a dozen children that also took the fenretinide~     powder with ketoconazole, and no toxicities have occurred that limited the dosage and no~     serious or unexpected side effects occurred. However, vincristine has never been given with~     fenretinide or fenretinide plus ketoconazole before. Vincristine has been been given before~     with ketoconazole to both children and adults with neuroblastomas and other cancers.~   "
68299|NCT02163343|"~     Elevated serum metal ions are well recognized in metal-on-metal articulations in total hip~     replacements. The objective of the study is to see if the Cathcart / Corail device implanted~     during a hemiarthroplasty (replacement of one half of the hip joint) results in elevated~     serum metal ion levels (cobalt & chromium) and to see if there is an association between~     size of Cathcart head used and metal ion levels.~   "
68300|NCT02163330|"~     Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible~     with treatment. First described in 1965 it consists of a triad of gait disturbance,~     cognitive deterioration, and urinary incontinence together with enlarged cerebral ventricles~     and normal cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection,~     mass lesions, or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or~     secondary forms of NPH are not considered here and the focus lies on the idiopathic type~     (iNPH). Prevalence of iNPH increases significantly with age. General estimates range from~     21.9 per 100,000 in total population surveys but increase up to 181.7 per 100,000 for people~     70 to 79 years of age. The clinical presentation varies significantly in severity and~     progression of symptoms. For diagnosis the entire triad does not have to be present. In~     typical cases gait and balance disturbances appear either before or concurrently with~     urinary incontinence or the onset of dementia. Current treatment recommendations are based~     on surgical diversion of CSF , with shunts placed either into the ventricular system or the~     lumbar subarachnoid space to a distal site, such as the peritoneal or the pleural cavity or~     the venous system, where the CSF can be reabsorbed . Even though immediate response rate to~     shunt treatment might be favorable and rates of 80% responders have been reported , the~     perioperative and long-term morbidity and mortality of CSF shunting procedures are~     significant. A meta-analysis of 44 articles found that the pooled, mean rate of shunt~     complication was 38% . Even though acute surgical complication rates are low, shunt~     dysfunctions and long-term complications are relatively common. Shunt malfunction (20%),~     subdural hematoma (2-17%), seizure (3-11%), shunt infection (3-6%) and intracerebral~     hematoma (3%) are the most common complications . In those with good long-term survival,~     sustained improvement is possible, with a rate of 39% documented after 5 years .In view of~     the complication rates, the lack of alternative treatment options and clinical studies is~     surprising. Even though iNPH per definition lacks raised intracranial pressure on spinal~     tap, monitoring of ICP prior to surgery reveals an increased amount of brief (usually 30~     seconds to 1 minute) increases in the static ICP, called Lundberg B waves, in patients which~     improve by shunt placements . When patients are scheduled for shunt treatment there is a~     waiting period of several weeks between diagnosis and operation due to congested waiting~     list.~      Acetazolamide (Diamox) has been shown to reduce the production of CSF in clinical cases of~     raised intracranial pressure . It is considered the drug of choice for the treatment of~     idiopathic intracranial pressure (pseudotumor cerebri). Intuitively a connection between~     Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have~     been published previously showing a fascinating improvement and success of treating iNPH~     with Acetazolamide. A systematic placebo controlled study concerning the use of~     Acetazolamide in iNPH is missing and would possibly pave the way to an alternative treatment~     option avoiding surgery and its complications.~   "
68301|NCT02163317|"~     This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic~     radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate~     cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause~     less damage to normal tissue.~   "
68350|NCT02162667|"~     This study will determine whether CT-P6 and Herceptin are equivalent in patients with~     early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the~     pathologic complete response rate will be equivalent in patients treated with neoadjuvant~     CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to~     10 cycles of therapy in the adjuvant setting.~   "
68302|NCT02163304|"~     The primary purpose of this study is to quantify activation of regions of the brain~     associated with taste, appetite, and reward after viewing high sugar and high fat (HS/HF)~     images compared to control images following ingestion of (1) an artificially sweetened~     solution, (2) a sucrose solution, and (3) a tasteless control solution in normal weight vs.~     obese women. This is a repeated measures study design; hence, data are collected on three~     days corresponding to the three solutions. Body mass index (BMI) is a between subjects~     measure.~        1. After consuming an artificially sweetened solution and a sucrose solution compared to a~          tasteless solution, viewing HS/HF food images vs. control images will result in higher~          activation of taste pathways (frontal operulum and anterior insula (FO/AI)) in the~          brain.~        2. After consumption of a sucrose solution compared to an artificially sweetened solution~          and a tasteless solution, viewing HS/HF food images vs. control images will result in~          higher activation of regions of the brain associate with appetite (hypothalamus).~        3. After consumption of a sucrose solution compared to an artificially sweetened solution~          and a tasteless solution, viewing HS/HF food images vs. control images will result in~          higher activation of regions of the brain associated with reward [amygdala, anterior~          cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA),~          striatum, insula] in obese but not normal weight women. After consuming an artificially~          sweetened solution compared to a tasteless solution, viewing HS/HF images vs. control~          images will result in no differences in activation of reward pathways of the brain.~   "
68303|NCT02163291|"~     Gastric cancer is the second cause of cancer related death and China has the most gastric~     cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy,~     postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed~     benefits these years, the prognosis of advanced gastric cancer is still not satisfactory.~     Optimal regimens and optimal method administration is still being found. Neoadjuvant~     chemotherapy has many advantages, including downstaging the tumor, increasing R0 rate, early~     eradicating of micrometastasis. In previous trials, combination of paclitaxel and s-1 has~     showed safety and tolerance in recurrent or metastatic gastric cancer. Using liposome as a~     carrier, paclitaxel has a better histocompatibility and cellular affinity, resulting a~     improved stability and reduced toxicity. In this phase II trial, we are going to study the~     safety and feasibility of paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.~   "
68304|NCT02163278|"~     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK)~     and pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male~     subjects.~   "
68305|NCT02163265|"~     Pectus excavatum or carinatum are the most common congenital deformations of the ventral~     thoracic wall. Several different surgical methods with different techniques to correct these~     deformations have been described.~      Some clinicians recommend a correction of the deformation to improve the cardiopulmonary~     efficiency. Other think that the correction has a more an aesthetic than a physiological~     benefit.~      The aim of our prospective study is to evaluate whether patients with PE or PC are suffering~     preoperatively from a cardiopulmonary limitation at rest and under physical stress and if~     there is a change of cardiopulmonary function after the surgical correction.~   "
68306|NCT02163252|"~     The purpose of this study is to examine whether providing additional intervention support to~     individuals with lower than expected weight loss within the initial stages of an~     internet-based behavioral weight loss program improves weight loss outcomes at Week 12,~     compared to the internet program alone.~   "
68307|NCT02163239|"~     This study evaluates the use of the FloShield System with the FloShield 10mm reusable~     Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study~     will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci®~     Robotic Surgical System during single-site laparoscopic surgery.~   "
68308|NCT02163226|"~     The goal of this clinical research study is to learn if 1 large dose of radiation therapy is~     better at controlling pain from cancer that has spread to the bones than 10 smaller doses of~     radiation. Researchers also want to learn if 1 large dose of radiation therapy can help~     decrease the use of drugs to control the pain, and if it can help to control the disease.~   "
68309|NCT02163213|"~     To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine~     Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal~     expression of pivotal genes including tight junction, secretory mechanisms, tissue repair~     proteins and chemokines in subjects with IBS-D.~   "
68310|NCT02163200|"~     Patients candidates for total hip replacement are, generally elderlies and have hip pain, we~     will check if the pressure to the soft tissue changes before and after operation using a~     tapet with pressure sensors sending the information to specific software.~   "
68311|NCT02163187|"~     The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will~     help patients to have more normal bowel movements. The InterStimTM device is a~     neuromodulating device. Neuromodulation is a way of changing the activity of the nervous~     system by using electrical stimulation. InterStimTM is FDA approved to help people who have~     a hard time controlling their bowl movements. This is called fecal incontinence.The device~     is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker~     by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it~     is initially tested to make sure it will work using a temporary wire and then, if~     successful, the device is permanently implanted.~   "
68312|NCT02163174|"~     -  Hypothesis: The investigators hypothesized that Pentoxifylline has potent~          anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in~          treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal~          mortality and morbidity.~        -  The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an~          adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.~   "
68313|NCT02163161|"~     Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a~     solid dose formulation of PF 04965842 relative to a suspension formulation under fasting~     conditions and the effect of food on the bioavailability of the solid dosage formulation of~     PF 04965842 in healthy subjects.~   "
70177|NCT02138786|"~     This is a multi-center, Phase 2, single arm, open-label study of oral selinexor monotherapy~     in patients in patients with Richter's transformation, arising in the setting of prior CLL,~     after at least one chemo-immunotherapy regimen for CLL.~   "
68316|NCT02163109|"~     Many serious illnesses are characterised by a lack of oxygen delivery to the body's tissues.~     This can be due to problems with the circulation, such as when the heart fails to pump blood~     efficiently or if the blood pressure is very low, or due to changes in the lungs preventing~     them from transferring oxygen effectively from the air into the blood.~      Many of the treatments used in critically ill patients are aimed at improving the supply of~     oxygen-rich blood to the tissues. These include drugs to increase the blood pressure or make~     the heart pump more forcibly, blood transfusions to increase the amount of oxygen that the~     blood can carry, and ventilators (breathing machines) to help the lungs introduce more~     oxygen into the bloodstream. Decisions to use such treatments are based on a number of~     factors. One of the most important is an assessment of how much oxygen an individual patient~     is using at a given time. Whilst it is possible to measure average oxygen consumption over a~     long period of time in healthy individuals, the equipment and techniques needed are simply~     not practical for routine use in the clinical setting of a critical care unit. Critical care~     doctors and nurses therefore have to rely on a number of different indicators of the~     adequacy of the amount of oxygen that is being provided in order to make decisions about how~     best to treat patients. Unfortunately, all of these have their limitations, are affected by~     other treatments patients may be receiving, and can be difficult to interpret. Examples~     include 'mixed venous oxygen saturation' (SvO2), that is the amount of oxygen in the blood~     coming back to the lungs from the body, ready to have more oxygen added, and blood lactate~     levels, which give an indication of whether the tissues have enough oxygen to produce the~     energy they need to function in an efficient manner.~      Our group has developed a device which can be added easily to the normal equipment used on a~     critical care ward when a patient is on a ventilator, which can accurately and rapidly~     measure the amount of oxygen the individual is consuming.~      This study will provide us with data so the investigators can define a normal range of~     oxygen consumption in these patients, and treatments which alter consumption. In a future~     study, once the investigators know what the normal range is, they can introduce new~     techniques to improve oxygen consumption in those patients whose consumption is less than~     ideal.~   "
68317|NCT02163096|"~     The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in~     children with a history of wheezing or asthma. BJHS is a common syndrome of joint and~     connective tissue laxity without any other rheumatologic disease. This assessment will be~     performed by using either method below depending upon if the child has a history of wheezing~     or severe asthma:~        1. Determine the correlation, if there is an increased rate of BJHS in children with a~          history of wheezing as well as if there is an increased history of wheezing in children~          with BJHS; or~        2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute~          worsening of symptoms) in children with BJHS compared to children with asthma without~          BJHS, to assess if it BJHS is associated more with children with severe asthma.~   "
68318|NCT02163083|"~     The purpose of this study is to investigate, whether the detection of lymph nodes by means~     of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted~     radical prostatectomy is higher than without the use of indocyanine green (ICG).~   "
68319|NCT02163070|"~     The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on~     nutritional status, inflammatory markers and oxidative stress in hemodialysis patients~   "
68320|NCT02163057|"~     This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and~     immunogenicity of INO-3112 DNA vaccine delivered by Electroporation to subjects with HPV~     associated head and neck squamous cell cancer.~   "
68321|NCT02163044|"~     Coronary heart disease (CHD) is the leading cause of death worldwide. The disease is~     characterized by a high mortality rate (about 40%) and a course continuously altered by~     lifestyle, gene polymorphisms and therapeutic treatment. Fasting concentration of blood~     lipids and lipoproteins only partially express the complex relation between dyslipidemia and~     CHD. Following the indication stated nearly 40 years ago by Zilversmit, there is now~     accumulating evidence that postprandial lipemia plays an important role in the atherogenic~     process [ref Kolovou], particularly that most hours of the day are spent in the postprandial~     state. Furthermore, the increases in blood glucose and triglycerides (TGs) following meals~     stimulate oxidative stress, impair endothelial function, and rises the inflammatory factors~     that lead to atherosclerosis. Previous studies reported on postprandial lipemia in subjects~     with obesity, metabolic syndrome, diabetes mellitus, elderly, patients with CHD and others.~     However, currently the estimation of cardiovascular disease risk is based on fasting blood~     values of triglycerides (TGs) and inflammatory markers. The effect of postprandial~     atherogenic factors on the initiation and progression of atherosclerosis is actually not~     known.The Hellenic Postprandial Lipemia Study (HPLS) was designed to study the consequences~     of postprandial lipemia in CRP as inflammatory marker in high-risk adults. Furthermore, the~     HPLS study will investigate whether hypolipidemic, hypoglycemic or antihypertensive~     medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal~     postprandial metabolism. Finally, the HPLS study is intending to evaluate the influence of~     gene polymorphisms involved in lipid and glucose metabolism on postprandial lipemia and~     cardiovascular outcomes.~   "
68322|NCT02163031|"~     Orthotopic heart transplantation is a well established therapeutic measure for end stage~     heart failure, leading to significant improvements in survival and quality of life. In the~     routine clinical practice, orthotopic heart transplantation patients receive periodic~     cardiac catheterization for early detection of allograft vascular disease.~      The coronary angiography of these patients is characterized for several technical~     difficulties, generally related to the presence of the aortotomy with anomalous implantation~     of the coronary ostia and to the orthotopic position of the allograft. For these reasons,~     trans femoral approach is usually preferred. In the last two decades, trans radial approach~     for coronary angiography emerged to be effective, safe and able to improve patient comfort.~     However, there is no universal consensus on the optimal choice of radial access from either~     the left or the right artery. Currently, this choice is largely dependent on the operator's~     preference. The trans right radial approach is generally preferred in routine clinical~     practice mainly due to its easier catheter manipulation for the operators from patient's~     right side, and the current design of radial compression devices for the right wrist in~     medical market. As such, a major barrier to prevent the wide adoption of the left radial~     access lies in some difficulty to reach the left wrist leaning over the patient,~     particularly for shorter operators or in obese patients. However, a great deal of attention~     has been recently directed toward the trans left radial access, as it has an important~     anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter~     route to the left coronary ostium, which could also reduce the risk of cerebrovascular~     complications.~      However, no data are available about the performance of trans left radial or trans-right~     radial approach in coronary angiography orthotopic heart transplantation patients. However,~     in this particular setting of patients, the left radial approach might reduce the technical~     difficulties related to the anatomical variations.~      In this single centre, prospective, randomized study, we sought to compare trans right~     radial versus trans left radial approach in terms of amount of contrast medium, radiation~     exposure, number of catheters used, cross over to the other access site rate and local and~     systemic complications in orthotopic heart transplantation patients.~   "
68323|NCT02163018|"~     Currently, there is no effective causal treatment for peanut allergy. A chemically modified,~     aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has~     been developed. Results from in vitro and in vivo preclinical studies demonstrate the~     immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial~     has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic~     patients.~   "
68577|NCT02159703|"~     To determine 2-year local (primary tumor site) control and toxicity rates in patients~     receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely~     resected, HPV-positive SCCA of the oropharynx.~      To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,~     omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of~     the oropharynx.~   "
68324|NCT02163005|"~     Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with~     contrast, unless they are premedicated. Premedication can result in a delay in diagnosis,~     that can be significant with acute conditions such as Pulmonary embolism.~      The investigators are evaluating the use of Gadolinium as an alternative contrast agent in~     CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not~     sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has~     better sensitivity to lower doses of intravenous contrast and the investigators aim to study~     its effectiveness in improving the enhancement with Gadolinium. The investigators will~     compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to~     assess the possibility that Gadolinium could be used as an alternative for patients who are~     suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a~     routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and~     Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.~   "
68325|NCT02162992|"~     Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA~     antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus~     erythematous (SLE). The aim of this study is to evaluate the relationship between SLE,~     arrhythmias and its serologic profile.~   "
68326|NCT02162979|"~     This study is to determine if Viagra is effective in reducing dyskinesias in patients with~     Parkinson's Disease.~   "
68327|NCT02162966|"~     Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post~     antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa,~     Acinetobacterbaumannii, and Klebsiella pneumonia.~   "
68328|NCT02162953|"~     Background: Autosomal recessive bestrophinopathy (ARB) is one of 5 blinding eye diseases~     caused by mutations in the gene BEST1. These diseases, collectively termed~     bestrophinopathies include ARB, Best vitelliform macular dystrophy (BVMD), adult-onset~     vitelliform dystrophy (AVMD), autosomal dominant vitreoretinalchoroidopathy (ADVIRC) and~     retinitis pigmentosa (RP) .~      Objective: To collect DNA/RNA and skin samples from individuals with ARB or other diseases~     due to mutations in the gene BEST1. These models will be used to identify and test~     therapeutic approaches to treating these diseases.~      Design: Study involves a one time donation of a skin punch biopsy and whole blood. Once the~     skin biopsy is obtained, skin fibroblasts will be isolated, which will be reprogrammed into~     iPSCs. RPE cells will be derived from the iPSCs~   "
68329|NCT02162940|"~     The impact of statin use on response to epidural steroid injections remains unknown and may~     well increase the effect considering the substantial anti-inflammatory properties. We thus~     tested the primary hypothesis that patients taking statins before and after the procedure~     will have lower VAS scores compared to patients not on statins. Secondarily we tested the~     hypothesis that statin users will have improved quality of life evaluated with Short Form 36~     (SF 36).~   "
68330|NCT02162927|"~     In the past, dietary nitrate supplementation has been shown to have clinical benefits in the~     treatment of cardiovascular issues. More recently, however, the focus of nitrate~     supplementation has shifted to focus of human performance, and has shown to increase the~     time to exhaustion during maximal intensity exercise and lower the cost of oxygen~     consumption during submaximal intensity exercise. Acutely, nitrate supplementation in the~     form of beetroot juice has been shown to increase strength measurements, as well as increase~     the time to complete a 2000 meter rowing ergometer test. However, to the author's knowledge,~     there are no studies that link the relationship between multi-day nitrate supplementation~     and the rowing test or the nitrate's effect on strength when in the salt form. Additionally,~     to the author's knowledge, no evidence has been published which relates dietary nitrate~     supplementation and its effects on a CrossFit circuit workout.~      Our central hypothesis is that six days of dietary nitrate supplementation will improve~     strength, endurance, a power more than a placebo in male CrossFit athletes.~   "
68331|NCT02162914|"~     The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II~     trial aiming to demonstrate an improvement of median PFS when treating locally advanced~     unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming)~     cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after~     GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or~     oxaliplatin)-based chemotherapy.~      The principal objective is to investigate Regorafenib efficacy by prospectively evaluating~     the PFS after the administration of Regorafenib combined with BSC as compared to placebo~     with BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in~     Regorafenib group).~   "
68332|NCT02162901|"~     The aim of this project is to evaluate the reach, effectiveness, and costs of two~     patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate~     and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired~     glucose tolerance) within a health care setting. The overall aim is consistent with the~     NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and~     community-based strategies for prevention of diabetes and its complications. While evidence~     of lifestyle interventions that increase physical activity and improve eating habits to~     achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues~     to mount, the translation of these interventions into effective programs to health care~     settings with modest resources remains a challenge. The proposed research project will~     conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled~     Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in~     achieving objectively verified weight loss relative to a standard care control at~     comparatively lower costs. Adult patients (18 years of age and older) at risk for developing~     diabetes will be randomized to either the Choice group or the Randomization group. Those~     patients randomized to the Choice group (n=240) will have the opportunity to choose one of~     two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated~     interactive voice response (IVR) systems targeting personal action planning to support~     lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention~     with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be~     randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).~     SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures~     include weight loss, cost, and reach of each program. Secondary outcome measures include~     physical activity behavior; eating behavior; and process evaluation. It is hypothesized that~     both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of~     weight loss at 6, 12, and 18 months following program initiation than SC but will not differ~     from one another. The investigators also hypothesize that the DVD/IVR will have broader~     reach and may be more cost-effective than SG/IVR or SC.~   "
68333|NCT02162888|"~     The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM)~     Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in~     patients with cancer.~   "
68334|NCT02162875|"~     The objective of this study is to determine the strategy for mass drug administration (MDA)~     which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in~     school-aged children after 4 years of intervention.~   "
68338|NCT02162823|"~     SPP study includes incidence cases of pancreatic cancer in the Stockholm county region from~     2007 to 2014. The purpose of SPP study is to estimate relative risk of pancreatic cancer in~     relation to snuff dipping, overweight/obesity, individual food items, food groups, dietary~     pattern and various nutrients; to estimate relative risk of pancreatic cancer in relation to~     exposure to nitrosamines, either endogenously or exogenously; to estimate relative risk of~     pancreatic cancer in relation to oral health and H.pylori infection and their interaction~     with ABO blood type; to estimation relative risk of pancreatic cancer in relation to~     hepatitis B or hepatitis C infection; to estimate relative risk of pancreatic cancer in~     relation to some genetic polymorphisms, either functional or being suggested in GWAS study;~     to estimate mutation profile in pancreatic cancer cases, and its correlation with~     environmental exposures, and the impacts on survival periods in pancreatic cancer patients.~      The MeSH name is Carcinoma, Pancreatic Ductal~   "
68339|NCT02162810|"~     The primary objective of this study is to determine the efficacy of administering a course~     of postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair~     as prevention against complications. Specifically, the study aims to assess if the steroids~     i) decrease the incidence of wound breakdown, fistula formation, stenosis or stricture~     formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and~     ii) improve the quality of wound healing including the overall cosmetic appearance of the~     phallus (i.e. location of the urethral meatus).~   "
68340|NCT02162797|"~     INTRODUCTION:~      An adequate zinc supplementation is essential for a good immunological function. However,~     zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and~     efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.~      HYPOTHESIS~      Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV~     patients after three months of daily consumption.~      Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV~     patients after three months of daily consumption~   "
68341|NCT02162784|"~     The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a~     combination drug product of budesonide and procaterol hydrochloride, in asthma patients.~     Patients with mild to moderate asthma will be recruited. There will be two study medication~     administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol~     hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is~     Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be~     administered by oral inhalation with the supervision of the investigator or a qualified~     staff.~   "
68342|NCT02162771|"~     This study is a Phase 1/3 prospective, randomised, parallel-group, active controlled, double~     blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate~     equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of~     CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients~     with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.~   "
68343|NCT02162758|"~     This study is designed to evaluate the effect of dexlansoprazole QD and BID dosing on the~     recurrence of intestinal metaplasia (IM) in subjects who achieved complete eradication of~     Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation~     (RFA).~   "
68344|NCT02162745|"~     Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of~     life. Most children with bronchiolitis have mild disease and are managed at home with~     support from primary care providers, while children with more severe symptoms require~     supportive therapy with oxygen and fluid administration.~      Neonates may be obligate nasal breathers until they are at least 2 months old and nasal~     obstruction may play a relevant role in respiratory resistances throughout the first months~     of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance.~     Some guidelines recommend to clear the nostrils of secretions to improve airway patency but~     no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was~     carried out.~      The aim of this randomized controlled trial is to compare normal saline and hypertonic~     solution for nasal irrigation versus simple supportive care in infants admitted to Emergency~     Department with bronchiolitis and mild desaturation.~   "
68345|NCT02162732|"~     The purpose of this study is to test the feasibility (ability to be done) of experimental~     technologies to determine a tumor's molecular makeup. This technology includes a genomic~     report based on DNA exomes and RNA sequencing that will be used to discover new ways to~     understand cancers and potentially predict the best treatments for patients with cancer in~     the future.~   "
68346|NCT02162719|"~     This multicenter, randomized, double-blind study will estimate the efficacy, safety and~     tolerability of ipatasertib combined with paclitaxel compared with placebo combined with~     paclitaxel in participants with inoperable locally advanced or metastatic triple-negative~     breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants~     and in participants with phosphatase and tensin homolog (PTEN)-low tumors.~   "
68347|NCT02162706|"~     Cortisol is a hormone critical for survival in times of stress. Currently most measurements~     are done with blood samples. The hypothesis of this study is cortisol measured from saliva~     using mass spectrometry can be used to replace measurements by blood.~   "
68348|NCT02162693|"~     Current medication treatments for KOA aim to relieve inflammation and pain, but they do~     little to delay or reverse the disease progression and most medications have obvious side~     effects. When the conservative treatments are useless to patients and joint deformities and~     joint disfunction, the patients may require surgery. Although surgery of the joints can~     relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.~   "
68349|NCT02162680|"~     The purpose of this study is to compare how well different anesthetic, or numbing, solutions~     injected under the skin work in reducing the discomfort associated with placing a catheter~     in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have~     been found to be effective in reducing discomfort when injected under the skin just prior to~     inserting the catheter. This study compares these two solutions, and will compare the~     discomfort that occurs both with and without using these solutions.~   "
69412|NCT02148796|"~     The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk~     infants for 10 days, monthly, for two consecutive years can increase time to occurrence of~     the first episode of wheezing lower respiratory tract illness (WLRI) during a third~     observation year after therapy~   "
68351|NCT02162654|"~     The RIPAT study is a prospective, randomized, double-blind study organized by the~     neurovascular group of the Clinical Department of Neurosurgery of Innsbruck Medical~     University, Innsbruck, Austria. Patients aged 18+ in whom the treatment of an un-ruptured~     intracranial aneurysm is indicated are eligible for study participation. Prior to aneurysm~     treatment, with the patient already under general anesthesia, the blood supply to an arm~     will be restricted for 3x 5minutes by inflating a standard blood pressure cuff. The study~     hypothesis is that this remote ischemic preconditioning maneuver is able to prevent a~     stroke during the following treatment of the aneurysm.~   "
68352|NCT02162641|"~     The purpose of this study is assess the technical and operational feasibility of a~     specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal~     cancer.~   "
68353|NCT02162628|"~     The purpose of this study is to compare safety and effectiveness of the Exair Prolapse~     Repair System for treatment of pelvic organ prolapse to traditional native tissue repair~     through 36 months of follow-up.~   "
68354|NCT02162615|"~     The purpose of this study is to collect information on the safety and effectiveness of~     Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results~     will be compared to the safety and effectiveness results in patients who have native tissue~     repair (without mesh) as their pelvic organ prolapse treatment.~   "
68355|NCT02162602|"~     Compromised bone strength and increased fracture susceptibility pose significant morbidity~     and health care costs in children. Inadequate childhood bone accretion also may have~     lifelong consequences. Bone fragility among children with chronic medical conditions is a~     special concern. Identifying children at-risk for bone fragility and factors affecting bone~     strength requires understanding normal bone development. Dual energy x-ray absorptiometry~     (DXA) is the most common method for measuring bone mineral content and bone density in~     children. There are bone density reference data for children ages 5-20 years. An important~     gap is the lack of reference data for children ages < 5 years, who also experience numerous~     medical conditions that threaten their bone health.~      Growth and body composition influence bone mineral accrual, and are important for~     interpreting bone density measurements in children with conditions that threaten bone~     health. Gross motor skills and subsequent physical activity may also affect bone accrual.~     Children with chronic illness are at risk of altered body composition, delayed growth and~     gross motor skills, and restricted physical activity. Understanding independent effects of~     growth, body composition, gross motor skills and physical activity on bone accrual will~     improve interpretation of bone density measurements and has important research and clinical~     applications for identifying risk factors and therapies for young children.~      This study will involve a longitudinal cohort of 280 children studied every 6 months for 3~     years, and a cross-sectional cohort of 240 children measured once. The study will be~     conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and~     the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers.~     Measurements will include bone density, growth and body composition, dietary intake, sleep,~     physical activity and gross motor skills. Results from this study will enable clinical bone~     health assessment of young children with disorders that threaten bone health, and identify~     factors that affect bone accrual.~   "
68356|NCT02162589|"~     Prospective Multicenter registry study to assess the safety and efficacy of clinically~     indicated peroral endoscopic myotomy (POEM) for the treatment of Achalasia~   "
68357|NCT02162576|"~     Propeller Health is collaborating with Walgreens Pharmacies, the City of Louisville,~     Qualcomm Life and other local partners to carry out a focused demonstration project that~     will evaluate the effectiveness of the Propeller Health approach to asthma management while~     exploring means to use real-time data on asthma exacerbations in a public health setting.~     The Asthma Data Innovation Demonstration Project (ADID) will use wireless sensor technology~     to develop spatial and temporal data on the use of rescue inhalers by 300 study subjects~     with asthma in the Louisville metropolitan area. Propeller Health will process these data to~     support two general strategies.~      Asthma self management: Rescue inhaler actuation data will be compiled into individualized~     feedback reports to support asthma self management. Propeller Health will combine~     information on individual rescue inhaler actuations with evidence-based asthma management~     tips into real-time reports that will be provided to subjects. ADID staff will evaluate any~     resulting improvements in asthma control that may be based on this information. Subjects may~     share reports with their healthcare providers.~      Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial~     and temporal asthma rescue inhaler actuation data to City personnel and authorized public~     health researchers in Louisville. These data will show the times and locations of the use of~     rescue inhalers by the 300 study subjects throughout the greater Louisville area. ADID staff~     will work with City personnel and researchers to investigate how this unprecedented level of~     detailed information on exacerbations can be used best to increase public awareness of~     environmental triggers while supporting public health surveillance efforts around~     respiratory diseases.~   "
68358|NCT02162563|"~     Colorectal cancer patients with initially unresectable liver-only metastases may be cured~     after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal~     neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for~     resectability.~      In this study colorectal cancer patients with initially unresectable liver-only metastases,~     as prospectively confirmed by an expert panel according to predefined criteria, will be~     tested for RAS and BRAF tumor mutation status. Patients with RAS mutant tumors will be~     randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1),~     and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS~     wildtype tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus~     either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be~     reviewed for resectability by a central panel, consisting of at least one radiologist and~     three surgeons every assessment. Central panel review will be performed prior to~     randomization as well as during treatment, as described in the protocol.~   "
68359|NCT02162550|"~     Investigators will be determining whether a once weekly injectable medication Bydureon~     versus placebo is able to reduce the development of atherosclerosis.~      Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will~     improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis~     plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these~     studies will provide novel information about the temporal relationship between Bydureon~     induced changes in risk factors, endothelial function and atherosclerosis progression.~   "
68374|NCT02162355|"~     The purpose of this multiple ascending dose study is to characterize the safety,~     tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics)~     of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in~     Japanese healthy subjects.~      Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects~     of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of~     once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese~     vs Caucasian healthy subjects.~   "
68360|NCT02162537|"~     The patients carrying a complicated primary lung cancer brain metastases die in less than 3~     months of delay disease in the absence of treatment. The median survival of these patients~     is approximately six months when the treatment associated with radiotherapy chemotherapy~     based on cisplatin is now the standard treatment. In most studies the patients die of their~     brain disease in one case only two, so it is likely that some patients do not require brain~     irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for~     patients in group B (without systematic irradiation) are not to suffer the side effects of~     this radiation. The risks are in the same group to see brain metastases become symptomatic.~      The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear:~     should all patients be irradiated systematically (since the reference treatment is~     involved and with the aim of obtaining better control of the brain lesions and maintaining a~     better neurological status) or should only the patients showing cerebral progression be~     irradiated (avoidance of possibly useless brain radiotherapy and its side effects). The aim~     of this study is to better determine the position of cerebral radiotherapy in this context.~      Main objective:~      determine whether there is a difference in terms of progression-free survival between a~     therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy~     cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy~     cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of~     cerebral progression in patients with NSCLC with asymptomatic brain metastases~   "
68361|NCT02162524|"~     The primary purpose of this study is to quantify activation of regions of the brain~     associated with appetite and reward after viewing high sugar and high fat (HS/HF) images~     compared to control images following long-term aerobic exercise.~        1. After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF~          food images vs. control images will result in higher activation of regions of the brain~          associate with appetite (hypothalamus).~        2. After long-term aerobic exercise compared to a no-exercise control group consumption of~          a sucrose solution compared to an artificially sweetened solution and a tasteless~          solution, viewing HS/HF food images vs. control images will result in lower activation~          of regions of the brain associated with reward [amygdala, anterior cingulate cortex~          (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula]~          in overweight and obese men and women.~      Exploratory Aims As exploratory aims, investigators will test a preliminary brain~     connectivity analysis.~   "
68362|NCT02162511|"~     The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic~     cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS~     system is currently approved for use in patients who have AML, and a genetically matched~     sibling donor. Through this protocol, the investigators will be able to offer potentially~     life-saving transplants to patients who have genetically mis-matched donor, who have no~     other options for treatment.~   "
68363|NCT02162498|"~     The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or~     treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in~     prevention of mother-to-child transmission (PMTCT); care; and treatment programming. Yet~     despite South Africa's adoption of this guidance, myriad challenges currently exist.~     Confusion in the public health care system related to mixed messaging around safe infant~     feeding and the provision of—and now withdrawal of—free formula milk have made adherence to~     exclusive breastfeeding a challenge in South Africa. Cultural, social, and psychological~     factors influence the ability of women to follow PMTCT guidelines, which include exclusive~     breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant~     diagnosis. Facility-based interventions alone are often inadequate to effect sustained~     behavioral changes in the face of multiple contextual factors. Community- and home-based~     support are needed, yet cost and systems constraints make these infeasible in many PMTCT~     programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this~     gap and provide a home-based support system for the mother. The feeding buddy, who is~     selected by an HIV-positive pregnant woman to support her in overcoming sociocultural~     challenges to adhering to various aspects of PMTCT programs, is not an employed health care~     worker, but rather an individual known to the mother, making the intervention extremely~     cost-effective, and requiring minimal resources to implement. In the Uthungulu District of~     KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme~     (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding~     buddy strategy is one of the strategies included in this overall package of care. While this~     strategy has been encouraged by the South African Department of Health, it has not~     previously been implemented nor obviously evaluated. In order to scale-up such a programme~     and justify the human resource costs, it is vital that such a programme be evaluated.~      The goal of this proposed research study is therefore to evaluate the effect of the feeding~     buddy strategy to support mothers to adhere to PMTCT recommendations.~      The investigators hypothesize that mothers who choose a feeding buddy will have increased~     rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as~     improved rates of early infant diagnosis and stigma reduction.~      This evaluation will provide valuable information to the Department of Health in terms of~     choosing best practice models for promoting HIV-free infant survival and optimum health of~     infants in resource limited settings. The project plans to employ a cluster randomized~     intervention design and will include 300 mothers and their infants as well as the 300~     buddies in the intervention group, as well as 300 mothers in the control group. All~     participants will be part of the WinOp feeding buddy intervention programme.~   "
68364|NCT02162485|"~     The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler~     with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream~   "
68365|NCT02162472|"~     The aim of this study is to determine if videocapillaroscopy could be used as an objective~     and reliable method to assess psoriasis severity and to document improvement during~     treatment by measuring changes in vascular features.~   "
68366|NCT02162459|"~     This study investigates the strength gains associated with resistance training in a group of~     18 male high school athletes consuming either a whey protein supplement or chocolate milk~     following their exercise.~   "
68367|NCT02162446|"~     The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for~     the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).~   "
68368|NCT02162433|"~     The investigators aim to investigate the effect of dexmedetomidine on the perioperative~     respiratory complications in this patient population undergoing both awake and deep tracheal~     extubation.~   "
68369|NCT02162420|"~     Fludarabine-based preparative regimen followed by an allogeneic hematopoietic stem cell~     transplant using related or unrelated donor in persons 0-70 years of age diagnosed with~     dyskeratosis congenita or severe aplastic anemia who have bone marrow failure characterized~     by a requirement for red blood cell and platelet transfusions. Three different preparative~     regimens are included based on disease and donor type.~   "
68370|NCT02162407|"~     This study is conducted in Europe. The aim of this study is to estimate the relationship~     between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous~     (i.v.) administration of insulin detemir and human soluble insulin.~   "
68371|NCT02162394|"~     The investigators are conducting a prospective, observational study to examine the ECG~     waveforms captured by the new medical device as compared to a traditional Holter monitor for~     subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac~     impulse and/or conduction disorders by qualified clinicians.~      The hypothesis is that this new medical device prototype is non-inferior to traditional~     Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and~     ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.~   "
68372|NCT02162381|"~     Study will include adults with abnormal visual fields. Half of them will be given either~     methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as~     controls. All Subjects will also have a complete eye examination, a short questionnaire and~     a questionnaire to screen for attention deficit disorder. The investigators will compare the~     visual field results between the 2 tests.~   "
68373|NCT02162368|"~     Spine surgery is the most common procedure in neurosurgical setting. Some centers have~     chosen the patient self-position to avoid complications such as accidental extubation or~     loss of the iv line. The aim of our retrospective study is to describe our experience in the~     laryngeal mask use for airway management in patient submitted to spine surgery in~     neurosurgery~   "
68414|NCT02161822|"~     Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a~     favorable safety profile. In our recent in vitro study, the addition of simvastatin to~     chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer~     cells (unpublished data). So we planned this study to investigate the synergistic effect of~     simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer~     patients.~   "
68375|NCT02162342|"~     The subjet is sitting on a chair and in front of him an adjustable (height) table with a~     glass of water. 17 passive reflective markers are placed on his upper extremities and torso.~     The subject is requested to reach the glass (once with the right hand and then with the left~     hand) and bring it to the mouth and drink. Then the subject put the glass back at the~     starting position. This is performed twice for each hand. In the second part, the same trial~     is repeated but muscle activity is recorded with surface electromyography.~   "
68376|NCT02162329|"~     The goal of this research study is to test Tibetan meditation as a therapy to teach cancer~     patients to change their brain functioning and to improve quality of life. Researchers want~     to compare the cancer patients' outcomes to people who have never had cancer.~   "
68377|NCT02162316|"~     This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication~     therapy and Motilitone in Functional Dyspepsia~   "
68378|NCT02162303|"~     The purpose of this trial is to assess the effects of colchicine on vascular inflammation~     measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect~     will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic~     investigation will be performed to identify genetic biomarkers of patient response.~   "
68379|NCT02162290|"~     The research will study the differences between interval training and continuous training~     among cardiac patients in a cardiac rehabilitation facility.~      The main objectives are:~        1. Functional capacity measures (VO2 max).~        2. Cardiac risk factors~        3. Quality of life assessments.~      Study hypothesis:~      Interval training will be more effective in improving functional capacity, cardiac risk~     factors and quality of life, compared to continuous training.~   "
68380|NCT02162277|"~     The frequency of osteoporosis in Japan is increasing. Also, the frequency of~     osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is~     urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the~     longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan.~     There are several problems in this issue from the medical site and the patient site. The aim~     of this study is, from the patient site, to increase the motivation of postmenopausal women~     for osteoporosis using osteoporotic diagnostic kit.~   "
68381|NCT02162264|"~     To investigate the factors that affect Aricept medication persistence rate and the safety~     and efficacy in patients with Alzheimer's Disease in clinical practice~   "
68382|NCT02162251|"~     To investigate the safety and effectiveness about administration of both donepezil~     hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical~     practice.~   "
68383|NCT02162238|"~     Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is~     73.5% and this is likely due at least in part to low bioavailable zinc from the local~     cereal-based diet. Interventions that will increase zinc intake could prove useful in the~     effort to control zinc deficiency. A potential strategy is to increase zinc intake through~     enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A,~     Switzerland) is capable of purifying water and at the same time enriching it with zinc at a~     variable concentration with mean delivery of approximately 1-4mg/L.~      Aims of the study: The primary aim of this study will be to quantify in under 5 year old~     children the contribution of the household LSF device to zinc intake and dietary zinc~     bioavailability in participating households. Secondary objectives are; 1) to assess change~     in serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to~     characterize composition of the intestinal flora of children in the intervention group~     compared to control.~      Study Design and Methods:~      Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2~     treatment arms in an effectiveness study (90 under-five's per treatment arm). Group one will~     receive the LSF device with the zinc delivery system; group 2 will receive a LSF without the~     zinc delivery system.~      Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the~     effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2~     non-consecutive days in the dry and wet season. Selected food samples will be collected for~     direct analysis of zinc and phytic acid content, to supplement data from food composition~     tables (FCT's). The dietary assessment data will be used to estimate the distribution of~     zinc intakes in this age group and the EAR cut-off method will be used to estimate the~     proportion at risk of inadequate intakes.~      Data on water intake from the LSF device will be obtained by personal diaries and tally~     counters. The Zn concentration of the filtered water will be measured weekly. Using these~     data and the data from the dietary assessment, the contribution of the LSF zinc delivery to~     the overall dietary zinc intake will be estimated.~      The effectiveness study will be conducted as a 6-month double blind randomised trial with 3~     assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be~     collected from under 5 year old children enrolled in the households for determination of~     serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin~     (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in~     the intervention and control group to assess the composition of the gut microflora and gut~     inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and~     endpoint of the study. Weekly active surveillance for incidence and severity of malaria,~     diarrhea and other infectious diseases will be done by questionnaire.~   "
68384|NCT02162225|"~     The investigators hypothesize that increasing plasma nitrite using dietary nitrate will~     improve platelet function and red cell deformability and decrease MCHC in patients with~     sickle cell disease. The investigators will test this hypothesis through administration of~     daily intake of beetroot juice (Unbeetable - Performance Drink) to patients with sickle cell~     disease for 28 days. The investigators will evaluate the safety of daily beet root juice~     intake in patients with sickle cell disease. In addition, the investigators will measure~     MCHC, red cell deformability, and platelet function (activation and aggregation) in response~     to daily intake of beet root juice in this patient population.~   "
68385|NCT02162212|"~     The primary goal of this project is to determine how advanced glycation end-product (AGEs)~     accumulation and shoulder movement (humeral thoracic range of motion and activity count)~     interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if~     an intervention consisting of a tailored dose of stretching and active shoulder movement can~     reduce these problems in people with diabetes mellitus (DM). The investigators will focus on~     the following measures that span health domains; Skin intrinsic fluorescence to measure~     AGEs; Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of~     motion and activity counts to measure shoulder movements; and the Disability of the Arm,~     Shoulder and Hand (DASH) questionnaire to measure patient reported pain and disability. The~     investigators will test the innovative hypothesis that metabolic and movement factors~     interact to cause severe shoulder problems in people with DM and that an optimized shoulder~     movement intervention can have an important impact on reducing the development of limited~     joint mobility, pain and disability in this population.~   "
68397|NCT02162043|"~     This project aims to evaluate a self-administered screening test for glaucoma, the second~     largest cause of blindness in the western world. New approaches to glaucoma screening are~     needed because a significant number of patients first present to hospitals with~     advanced-stage glaucoma and late presentation is associated with a much higher risk for~     future blindness. This project will develop a new user-friendly visual field test that will~     be made available through the internet for self-testing. It will conduct both hospital-based~     and community-based clinical trials to establish benefits and costs of this new test.~   "
68386|NCT02162199|"~     The sponsor is trying to develop a medicine for infections that are not cured by regular~     antibiotics. They have an experimental drug called Debio 1450 that may work. They need about~     48 healthy adults to volunteer for this study.~      This study looks at what the body does to the drug. It measures how the amount of drug in~     blood and urine changes over time.~      From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to~     the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers~     to participate or serve as alternates. Alternates might not actually complete the study~     procedures.~      The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2~     receive Placebo. The drug each participant receives is decided by chance - like flipping a~     coin.~      Eligible volunteers check into the clinic for testing and those chosen to participate remain~     for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is~     required. Participants must stay at the clinic for the length of the study.~      This study is a dose escalation study. That means that if no safety concerns come up a new~     group starts. Each new group of eight participants receives more capsules.~      The study product is contained in capsules. Each capsule contains either placebo or 40 mg~     Debio 1450. After fasting overnight, the first two participants in the group receive their~     capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side~     effects for 24 hours, the remaining six participants receive their assigned capsules.~      The plan is to increase the dose for the next group. The study doctor reviews the~     measurements collected from each group after three days. He may decide to repeat, increase,~     or lower the dose or even stop the study. The most any participant receives is 800 mg in 20~     capsules.~   "
68387|NCT02162186|"~     The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at~     2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has~     been any movement or wear in the hip stem over the course of the study. The study will also~     record clinical data on each patient using various functional tests and questionnaires at~     the same intervals.~   "
68388|NCT02162173|"~     Background: Familial adenomatous polyposis (FAP) patients are at risk to develop~     periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of~     the lesion is generally required to identify the presence of adenoma. However, the risk of~     tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous,~     therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and~     Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with~     NPV≥ 90% is required.~      Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI)~     and probe-based confocal endomicroscopy (pCLE) in FAP patients.~      Design: Diagnostic study.~      Setting: Single tertiary-care referral center.~      Patients: Twenty-six patients with previously diagnosed with FAP.~      Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by~     two different endoscopists for each of the technique. Histology from the matched lesion was~     used as the gold standard.~      Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and~     accuracy. With the threshold for negative predictive value (NPV) ≥ 90%~   "
68389|NCT02162160|"~     Generate more information on the use of the Probiotic Intimate Crème regarding feeling of~     dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora~     and presence of coliform bacteria in respect to E. coli in the intimate area of women before~     use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days~     after (9-11 days) finished crème-usage.~      The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women~     with use of a probiotic creme.~   "
68390|NCT02162147|"~     Patient safety is an internationally recognized health care priority. Canadian data suggests~     that about 8% of adults admitted to hospital experience unintended harm (or 'adverse~     events') from the health care provided during their hospital stay. On a national level, this~     represents almost 25,000 preventable deaths among hospitalized adults each year. The~     emergency department is recognized as a high-risk environment for adverse events but most~     patient safety research is not specific to the emergency department. As well, the vast~     majority of people treated in the emergency department are sent home after their visit; yet~     safety research focuses primarily on people who are admitted to hospital. Finally, although~     children have also been identified as particularly high risk for suffering adverse events,~     very little research has been done on how often these events occur among children who visit~     the emergency department. Our study will address this gap in our knowledge about patient~     safety and provide important information on the frequency, severity and preventability of~     adverse events occurring among children in the emergency department. This information will~     help us to improve the safety of emergency department care for all Canadian children.~   "
68391|NCT02162134|"~     Laparoscopic cholecystectomy is now very common procedure to remove the gall bladder from~     abdomen. After this procedure many patients suffer from the non functioning of intestine and~     stomach which is very common after any abdominal surgery. Many efforts tried to reduce this~     non functioning period or postoperative ileus but non of them was superior later on. The~     investigators want to evaluate the role of chewing gum for reducing postoperative ileus. The~     investigators hypothesis is that Chewing gum after laparoscopic cholecystectomy reduces~     postoperative ileus and sugared preparations are more effective to reduce it.~   "
68392|NCT02162121|"~     Stimulating catheters have been introduced to reduce the incidence of secondary failure~     after continuous peripheral nerve blocks, but they effectiveness over traditional~     nonstimulating catheters is still controversial. The aim of this prospective, randomized,~     blinded study is to detect if stimulating catheters improve postoperative compared with~     conventional non-stimulating catheters.~   "
68393|NCT02162095|"~     Patients with chronic obstructive pulmonary disease suffer from significant cardiovascular~     morbidity and mortality. This study wants to determine whether chronic obstructive pulmonary~     disease might be a risk factor for coronary atherosclerosis and other cardiac markers~     independent of conventional cardiovascular risk factors. The study is designed as a~     retrospective matched case-control study with follow-up via telephone interview.~   "
68394|NCT02162082|"~     To evaluate the long-term results after recanalization of coronary chronic total occlusions.~   "
68395|NCT02162069|"~     To evaluate the long-term results after transcatheter aortic valve replacement~   "
68396|NCT02162056|"~     To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold~     (BVS) system in patients with coronary artery disease~   "
68398|NCT02162030|"~     The purpose of this study is to determine whether a specific component of Acceptance and~     Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this~     therapeutic approach.~   "
69430|NCT02148562|"~     In this project proposal, the investigators will investigate the genetic alterations of~     Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage~     liver disease. Additionally, the investigators will compare and link these data sets with~     three genetic factors involved in immune system response.~   "
68400|NCT02162004|"~     The potential of currently available diabetes technologies could be further exploited. The~     investigators propose that sensor-augmented insulin pump therapy may be improved by~     continuous correction, i.e. continuous evaluation of the need for correction boluses. In~     practice, this is carried out by running the bolus calculator every 10 minutes. The glucose~     sensor will provide the bolus calculator with glucose input. Many times, the bolus~     calculator will come to the result that no insulin is needed. However, when the blood~     glucose is above the pre-set target value and a correction bolus is needed, an appropriate~     bolus is automatically delivered by the insulin pump.~      The investigators hypothesize that sensor-augmented continuous correction insulin pump~     therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients~     with type 1 diabetes.~   "
68401|NCT02161991|"~     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention~     of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up~     to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell~     lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence~     aprepitant plasma concentration, which may lead to the individual difference of CINV control~     rate.~   "
68402|NCT02161978|"~     project is a pilot prospective, longitudinal, before-after, open label multicentric study.~   "
68403|NCT02161965|"~     The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is~     a comparative, parallel, prospective, controlled and randomized study of the structural and~     functional impact of rivaroxaban versus anti-vitamin K drugs on the arterial vasculature.~   "
68404|NCT02161952|"~     The aim of this study was to assess whether two-year treatment with Pirfenidone influence~     necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.~   "
68405|NCT02161939|"~     The primary objective of this program is to provide DCV for 24 weeks to be given in~     combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or~     post-liver transplant subjects with chronic hepatitis C recurrence with either advanced~     fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately~     life-threatening condition or experienced an event that has decreased their life expectancy~     to <12 months, therefore, no research hypothesis will be tested and no specific endpoints~     are defined. However, safety data will be collected throughout the study as well as efficacy~     data~   "
68406|NCT02161926|"~     The prevalence of obesity is growing in elderly with heavy consequences in term of medical~     complications and mortality, so that this is nowadays an important public health issue.~      The major therapeutic solution is dietary restrictions, but and the advantages and the~     metabolic consequences are not well known in elderly. The MONA study main aim is to assess~     the metabolic changes in this population, after dietary restrictions, compared to young~     people.~   "
68407|NCT02161913|"~     Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries~     result in incredibly difficult, long-term, life adjustments both for patients and their~     caregivers. Many families continue to struggle with the physical, emotional and social~     impacts of SCI for months and years after the injury. Family education and support improves~     the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but~     little effort has been made to provide such interventions for persons with SCI and their~     caregivers. The proposed study will address this problem by refining and testing a group~     treatment for SCI called Multi-family Group (MFG) intervention. The groups will include~     people with SCI and their primary caregivers, and will be facilitated by an educator who~     is a health care provider who works with people with SCI. By providing education about the~     management of SCI and support in an MFG format, quality of life for persons with SCI is~     predicted to be improved. In turn, it is expected that caregivers will also benefit from the~     information, problem-solving activities, and social support that they receive from the~     educators and other group members. The investigators will recruit 32 individuals with SCI~     who have been discharged from inpatient rehabilitation within the previous three years and~     their primary caregivers. Participants will be randomized to the MFG intervention or to an~     education control condition and tested before and after treatment and 6 months following~     treatment. It is hypothesized that participants receiving MFG-SCI will have better outcomes~     than controls on measures of quality of life, health, and adjustment. The study will also~     test whether participants who are more recently discharged from inpatient rehabilitation~     will experience greater benefit from the MFG intervention or the education control~     intervention. If the outcomes support the hypotheses, the MFG intervention should be made~     available to those with SCI and their caregivers.~   "
68408|NCT02161900|"~     TITLE: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment~     for Breast Cancer~      Yoga and Quality of life:~      Yoga is based on the practice of physical postures, breathing techniques and meditation.~     Philosophically, it aims at increasing the body's ability to master the mind with the goal~     of spiritual awareness and connection. A randomized trial of yoga in women with breast~     cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at~     3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of~     meaning in cancer by 3 months. Randomized studies have demonstrated evidence of yoga~     improving the emotional well being of women with breast cancer and improving their~     distressed mood, thus providing a buffering effect on QOL. The main beneficial effects~     demonstrated are on social functioning. Among patients not receiving chemotherapy, yoga~     appears to enhance emotional well-being and mood and may serve to buffer deterioration in~     both overall and specific domains of QOL.~      EVALUATION TOOLS- European Organisation for Research and Treatment of Cancer-Quality of Life~     Questionnaire (EORTC QLQ-C30 & BR-23) Brief Fatigue Inventory VAS (Pain score) Spirituality~     Questionnaire Pulmonary function test Objective assessment~      STUDY ENDPOINTS- Primary end points- Disease free survival Secondary end points- Quality of~     life & Improvements in overall survival~      STUDY DESIGN TREATMENT PLAN - All newly diagnosed cases with stage I-III of breast cancer~     who present to Tata Memorial Hospital will be randomly assigned to perform either a set of~     'Yogic and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to~     as exercise II)./ Patients will begin the exercises within a week of starting treatment.~      Both arms of the study will receive a training session one hour per day for the first week,~     during which they will be instructed to practice daily and maintain a daily log. The other~     evaluation tools will be used as per the assessment time line (enclosed).The exercises in~     the Exercise I arm (Yoga and conventional exercises) will be upgraded within the next 2 days~     to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase~     I and II. Patients will be assessed at 6 months for compliance to phase II exercises. Only~     if patients are fulfilling the criteria for accuracy, sequence and duration of phase II~     exercises, will they be taught phase III exercises. Patients who are unable to do phase II~     exercises at 6 months will be re taught phase II exercises. These patients will then be re~     assessed at 1 year for up gradation to phase III. Six months after completion of phase III~     exercises, patients will be assessed for compliance to phase III exercises. Patients will~     also undergo an objective assessment at 1 year. An additional up gradation will be after~     completion of adjuvant therapy at 6 months.~      Patients will be followed up for a period of 5 years. DFS will be measured from the time of~     randomization to either progression or death. Quality of life will be measured at baseline~     and every six monthly using the functional assessment cancer therapy- quality of life.~     Quality of Life analysis at 400 patients will be performed with appropriate correction for~     multiple analyses applied.~      STATISTICAL ANALYSIS- For an expected 50% 5 year disease free survival (DFS) for the control~     group, the expected 5 years DFS for the intervention group will be 60%. With a two-sided~     analysis, and at 80% power and 95% confidence to detect a 10% difference between the arms,~     the sample size would be 761 patients. Assuming a 10% loss to follow up, a total of 850~     patients would be accrued. We expect to complete accrual in 3 year.~      RANDOMIZATION AND STRATIFICATION- Randomization for intervention will be done centrally from~     Clinical Research Secretariat and patient will be stratified by~      Menopausal status: Pre + Peri or Post Neoadjuvant or adjuvant treatment Stage of disease:~     I/II/III ANALYSIS- Disease Free Survival (DFS) will be calculated from the date of~     randomization to the date of local, regional or distant relapse or death from any cause and~     will be censored at the last date of follow up for the patients that are alive and disease~     free or have been lost to follow up.~      Overall Survival (OS) will be calculated from the date of randomization to the date of death~     or censored at the date of last follow up for the patients who are alive or lost to follow~     up. DFS and OS will be evaluated using Kaplan Meier and compared by Log-rank test. The Cox~     proportional hazard model will be used to assess the impact of intervention after correction~     for stratification, menopausal status and age.~   "
68409|NCT02161887|"~     The overall objective of this study is to develop and test an efficient set of self-report~     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual~     factors important in healing. The initial phase of the study involves developing and~     refining an item bank. During the initial 'item bank development' phase, the investigators~     will run focus groups and cognitive interviews with individuals who participate in CAM and~     conventional medicine interventions. The next step of instrument development is called~     Calibration, and involves administering the revised item bank to an internet sample and to~     persons who receive services in a CAM clinic and a conventional primary care setting. The~     items will be calibrated using item response theory and classical test theory. This will~     result in a computerized adaptive testing version of the instrument, as well as a static~     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to~     the final, Validation Phase of the study. The final phase of the project will involve~     conducting initial validation studies of the set of instruments. The set of instruments will~     be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate~     the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of~     200 persons with chronic low back pain or neck pain who are receiving physical therapy,~     chiropractic care, acupuncture, medical management, or mindfulness-based stress reduction.~     For convergent validity, the HEAL is expected to display moderate to large correlations with~     measures of similar constructs. The HEAL is expected to correlate modestly with self-report~     measures of general psychosocial functioning, in support of discriminant validity. Finally,~     HEAL scores should account for a significant proportion of the variance in treatment~     outcome, supporting predictive validity.~   "
68410|NCT02161874|"~     This study evaluates the T3 implant system for the preservation of alveolar crestal bone and~     the establishment of initial integration. The new surface-treated features of the implant~     may contribute to improved soft and hard tissue healing. The success rate of the T3 implant~     will be no different than that of the control implant, which possess similar geometry but~     different surface treatments.~   "
68411|NCT02161861|"~     cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human.~     It improves sperm movement's parameters.~      It has been studied over 3 generations of mice and appears without any side effects. The~     Agence de la BioMédecine has given the authorization for testing the peptide in human IVF.~      It is expected to improve the fertilization rate, and thus provide more embryos per IVF~     attempt.~      160 couples will be included over 15 months. Patient sperm parameters should be suitable for~     IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly~     distributed to one of the 2 groups The first group will be inseminated with 105/ml motile~     spermatozoa. The second will be similarly inseminated but in a middle which will be~     supplemented with cFEE 100µM.~      Criteria: number of embryos in each group~   "
69655|NCT02145637|"~     This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose~     (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that~     inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.~   "
68415|NCT02161809|"~     The investigators long-term goal is to increase the number of Summer Day Camps (SDC) that~     meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA)~     Standards. The objective is to evaluate the effectiveness of a multi-component intervention~     designed to increase children's PA levels and improve the quality of lunches and snacks~     children consume in SDCs. The HEPA intervention is designed to target children, parents,~     staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC~     leaders to train their staff to deliver and integrate the intervention into routine~     practice. In the proposed study, the investigators will evaluate these HEPA strategies,~     using a 4-year randomized controlled trial with 20 SDCs. An important feature of the study~     will be the evaluation of maintenance of the intervention after the removal of research~     support (e.g., training, boosters) during the final year, as well as costs associated with~     implementation.~      The investigators hypothesize that intervention SDCs will achieve significantly greater~     increases in HEPA, compared to control SDCs. The investigators expect the study to support~     the cost-effectiveness and maintenance of our strategies for promoting HEPA that will~     facilitate SDCs meeting newly-established HEPA standards for this setting.~   "
68416|NCT02161796|"~     This study evaluates the concentration of FG-4592 in the blood over a certain period after~     the intake of different doses, and assesses the effects, the safety and the tolerability of~     the study drug in healthy young and elderly male and female subjects.~      On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a~     placebo, depending on the treatment sequence to which they are randomized. For each period~     the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all~     assessments are completed on Day 4 of each period, and return for an End of Study visit~     (ESV) between 5 and 9 days after the last assessment of Period 4.~   "
68417|NCT02161783|"~     This is a guideline for the treatment of graft failure after hematopoietic stem cell~     transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low~     dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after~     initial graft failure.~      The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a~     haploidentical related donor. The source of stem cells will be determined by the transplant~     team based on factors such as patient's age, medical history, donor availability and will be~     according to the current University of Minnesota Blood and Marrow Transplantation Program~     selection guidelines.~   "
68418|NCT02161770|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment~     compared to patients with normal hepatic function; Part B will allow any patient with mild~     or moderate hepatic impairment or normal hepatic function, who completes Part A, continued~     access to AZD9291 after the PK phase and will provide additional safety data.~   "
68419|NCT02161757|"~     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase~     3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with~     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist~   "
68420|NCT02161744|"~     The purpose of this study is: 1.- to assess the safety and tolerability of autologous~     adipose derived stem cells (aADSC) administered intravenously in patients with chronic~     obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of~     lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control~     baseline of 6 weeks.~      Patients will be followed up for 12 months after the therapy.~   "
68421|NCT02161731|"~     All study participants will receive both warfarin and a study drug called evacetrapib. The~     main purpose of this study is to look at how much warfarin gets into the blood stream and~     how long it takes the body to get rid of warfarin when given both with and without~     evacetrapib. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent~     blood clots when given with evacetrapib by measuring the time it takes for blood to clot and~     comparing it to an average of the international normalized ratio (INR). INR measures the~     time it takes for blood to clot and compares it to an average.~      The study will last approximately 5 weeks, not including screening.~   "
68422|NCT02161718|"~     This double-blind, randomized study will evaluate the efficacy, safety and tolerability of~     ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).~   "
68423|NCT02161705|"~     Primary Objective To determine if post-operative static pain scores differ between women~     undergoing bilateral mastectomy followed by bilateral immediate tissue expander~     reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)~     pre-operatively placed paravertebral blocks.~      Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of~     surgery while the patient is still hospitalized (post-operative day 0). This will be~     patient-provided data. Unblinded data analysis will compare scores between treatment and~     control groups.~      Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,~     and sleep interference differ between women undergoing bilateral mastectomy followed by~     bilateral immediate tissue expander reconstruction randomized either to ropivacaine-~     (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.~      Pain score, opioids use, nausea, and sleep interference data will be collected via patient~     self-report. When possible (i.e., while hospitalized) objective data on opioids and other~     pain medication administered to the patient will be used.~      Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36~     Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and~     Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral~     immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or~     saline- (placebo) pre-operatively placed paravertebral blocks.~      This data will be collected via validated questionnaires through patient interviews at~     3-months, 2-years, and 4-years (±14 days) after surgery.~      Once enrolled in the study, participants will be encouraged to remain in the study for the 4~     years following surgery in order to get final pain scores and quality-of-life/health outcome~     survey information. Participants who cannot be contacted after several phone attempts and~     the sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year~     outcome assessments will be considered lost to follow-up.~   "
68424|NCT02161692|"~     The purpose of this study is to determine whether the use of a sequential high dose~     chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin,~     etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.~   "
68425|NCT02161679|"~     This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132~     alone and in combination with carboplatin in patients with triple-negative breast cancer.~     IMMU132 will be administered once-weekly for the first 2 weeks of 3-week treatment cycles.~     For those patients assigned to also receive carboplatin, will receive it on the same~     schedules starting 30 minutes after the completion of IMMU-132 administration. Patients may~     receive up to a maximum total of 8 cycles.~   "
68592|NCT02159508|"~     The purpose of this study is to assess the effect of a pre-planned patient-adjusted~     intensive nutritional counselling given by a dietitian several times during~     (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in~     the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck~     squamous cell cancer.~   "
68426|NCT02161666|"~     To examine pancreatic islet function and incretin function during intravenous and oral~     stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance.~     We hypothesize that islet cell and incretin function is enhanced in response to oral, but~     not intravenous, stimulation - i.e. incretin released from the gut in response to oral~     stimulation play a key role for the enhanced islet function after gastric bypass surgery.~   "
68427|NCT02161653|"~     The purpose of this study is to determine whether metadoxine is effective for improve~     survival and reduced oxidative stress in patients with severe alcoholic hepatitis.~   "
68428|NCT02161640|"~     Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory~     conditions acquired due to genetic susceptibility and/or environmental triggers. The disease~     manifestations are being increasingly seen in young children and the life-long debilitation~     has a severe effect on quality of life. Limited evidence suggests, although rare, in some~     young IBD individuals vascular complications may ensue. This leads to increased risk of~     vascular problems such as thrombosis, arterial disease and stroke.~      In the present project we aim to study and highlight potential vascular changes in young~     Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender~     matched controls. Vasculature will be measured in multiple ways including blood analysis in~     the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound~     arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of~     vascular dysfunction as this will open new avenues for early therapeutic intervention.~   "
68429|NCT02161627|"~     The aims of the study are to compare automatic control of spinal cord stimulation with~     manual control in patients with chronic pain of the trunk and limbs~   "
68430|NCT02161614|"~     The aim of this study is to evaluate the vascular effects of estradiol valerate on~     climacteric women measured by flow-mediated evaluation of the brachial artery using high~     resolution ultrasound and compare to placebo.~   "
68431|NCT02161601|"~     During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the~     cricoid cartilage of the patient in order to prevent passive regurgitation of gastric~     content into the pharynx. This maneuver is called cricoid pressure.~      Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid~     cartilage in many patients. Despite this, the effectiveness of an incorrectly applied~     cricoid pressure has not been investigated. In this study we have used high-resolution~     manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied~     cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid~     pressure (against the thyroid cartilage and against the trachea) during a rapid sequence~     induction.~   "
68432|NCT02161588|"~     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics~     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the~     investigated drug on the body), safety and tolerability of oral semaglutide in healthy male~     Japanese and Caucasian subjects.~   "
68433|NCT02161575|"~     AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and~     blindness registration in the UK . It is a disease which affects the retina (the nerve and~     blood vessel network at the back of the eye responsible for vision). Patients can suffer~     with severe visual loss and have difficulties with every day tasks such as recognising~     faces, reading & driving.~      There are two variations of the disease, a 'dry' type & a 'wet' type also known as~     neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the~     retina, in part due to higher than normal levels of a protein called Vascular Endothelial~     Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for~     patients with wAMD have dramatically improved.~      There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of~     patients have a successful outcome with treatment, many patients experience suboptimal~     response. This study will evaluate if these patients experience a benefit from a switch to a~     different antiVEGF drug treatment. In this study nAMD patients who are showing no or poor to~     response to treatment with aflibercept will be switched to ranibizumab to assess if there is~     any benefit in terms of treatment outcomes.~      Patients will visit the hospital clinic 8 times over the 7 - 8 month study period. Monthly~     ranibizumab injections will be given for the first 3 months, then monthly as required for~     the next 3 months. 162 patients will be treated in around 33 centres in Europe, of which~     approximately 127 patients will be included in the UK~   "
68434|NCT02161562|"~     This trial will assess the efficacy of optimized re-treatment therapy with omalizumab (150mg~     or 300mg) after relapse, in patients with Chronic Spontaneous Urticaria who were clinically~     well-controlled following their first course of treatment with omalizumab (150mg or 300mg).~      Will also assess the benefit of uptitrating to 300mg dose those patients who are not~     well-controlled following their first course of treatment with omalizumab 150mg.~   "
68435|NCT02161549|"~     Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby~     integrating colon cleansing, screening and treatment into one procedure.~      The device creates turbulence within the colon using water jets. The colon's fecal fluids~     are evacuated by the system.~   "
68436|NCT02161536|"~     The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.~   "
68462|NCT02161198|"~     Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from~     the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its~     function as an immunomodulatory molecule. The present study performed to evaluate the safety~     and beneficial effects of Y-75 on immune function in a group of healthy adults.~      The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of~     natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear~     phagocytes, and serum levels of monocyte-derived mediators.~   "
68463|NCT02161185|"~     The purpose of this study is to examine the long-term safety and tolerability of USL261 in~     the treatment of seizure clusters.~   "
68491|NCT02160821|"~     Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional~     anesthesia technique for providing postoperative lower abdominal analgesia. Complications~     associated with TAPB are very rare and pose a lower overall risk to the patient receiving a~     TAPB versus a caudal block, which is considered the gold standard for pediatric lower~     abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to~     caudal block initially in providing postoperative pain control but would show improved pain~     relief beyond the anticipated caudal duration.~   "
68437|NCT02161523|"~     In addition to their role in allergic inflammation, mast cells are often found at the site~     of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on~     the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast~     growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8)~     can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.~      The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung~     cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.~      In this work, we are interested to determine the factors in lung cancer microenvironment~     that attribute to mast cell activation. Beside the tumor cells themselves, the cancer~     microenvironment includes other cells such as fibroblasts. The fibroblasts arising from~     tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have~     different feature compared to normal fibroblasts (NFs). In this work we are interested to~     determine whether CAF cells derived from lung tumors, together with the lung cancer cells,~     or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate~     and/ or to release various cytokines and chemokines.~      For this propose, during surgery of patients with lung cancer, we will take unnecessary~     sample from the cancer and from normal area for purification of CAF or normal fibroblast~     cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or~     microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will~     be collected for determine degranulation and cytokine release from these mast cells.~   "
68438|NCT02161510|"~     The objective of this study is to identify a safe dose of MK-2248 in participants with~     Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from~     baseline. It is anticipated that once-daily administration of a safe and well tolerated dose~     of MK-2248 will reduce VL by at least 3 log10 IU/mL.~   "
68439|NCT02161497|"~     The investigators are studying the difference between the history taken from parents prior~     to their child's anesthesia to information gleaned routinely from a patient information~     system called Ofek.~   "
68440|NCT02161484|"~     The purpose of this research study is to evaluate the analgesic efficacy of adding a single~     shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients~     undergoing total hip replacement.~   "
68441|NCT02161471|"~     The purpose of this study is to determine whether patients with repaired congenital heart~     disease show differences in size or function of their heart atria compared to normal~     controls and depending on the nature of their heart disease.~   "
68442|NCT02161458|"~     Alzheimers disease (AD) is a devastating illness, estimated to affect 5 million patients in~     the United States alone and projected to increase dramatically over the next decades as the~     population ages unless preventive measures can be developed. The investigators have~     preliminary evidence that selective serotonin reuptake inhibitor (SSRI) antidepressants~     lower the amount of amyloid plaques in the human brain. The interventions now propose to~     study the effects of an SSRI (escitalopram) on levels of amyloid beta peptide (the major~     constituent of the plaques) in the cerebrospinal fluid (CSF) of cognitively normal older~     adults. The investigators will measure CSF Amyloid Beta levels before and after two weeks of~     treatment with escitalopram using a double blind placebo-controlled study design with~     approximately 30 cognitively normal participants, age 65-85, with a Clinical Dementia Rating~     scale, [CDR] = 0. They will be recruited from the community. Participants will be randomized~     (approximately 15 per group). Participants will have three office visits: the first visit~     will be for screening and consent and participants will be randomized 1:1 to receive~     escitalopram or placebo for two weeks; the second and the third visits will be for lumbar~     puncture (LP) and CSF analysis. Each LP visit will take about 2 hours. The second LP will~     occur two weeks after the first LP. At each LP visit, approximately 1½ tablespoons of blood~     and 4 teaspoons of CSF will be obtained. Participants randomized to escitalopram will take~     10 mg escitalopram for 5 days, then take 20 mg escitalopram for the remainder of the two~     week exposure period, and then taper down to 10mg for 3 days. The current proposal will test~     whether clinically relevant doses of an SSRI reduce CSF levels of Amyloid Beta in healthy~     older human participants. The investigators hypothesize that compared to placebo,~     participants receiving escitalopram will show significantly lower Amyloid Beta levels in the~     second CSF sample.~   "
68443|NCT02161445|"~     the gold standard for the diagnostic of acute heart failure is based on clinical, biological~     (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is~     difficult and requires further investigations.~      BNP dosages and echocardiography are not always available in many medical centers,~     especially in emergency departements, and are expensive.~      we investigated the use of alternative methods, such as the systolic time intervals (STI),~     in the diagnosis of acute heart failure (AHF) in emergency departement patients consulting~     for dyspnea.~   "
68444|NCT02161432|"~     To determine the relative bioavailability of an BI 187004 tablet formulation compared to an~     oral solution of BI 187004 and to assess the influence of food on the bioavailability of the~     tablet formulation.~   "
68445|NCT02161419|"~     This is a study to investigate the potential clinical benefit of roniciclib when given in~     combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line~     treatment in patients with extensive disease small cell lung cancer. Approximately 140~     patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in~     combination with chemotherapy.~      Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. The~     growth of the tumor may be decreased by preventing these specific proteins from functioning.~     By specifically targeting these proteins, roniciclib in combination with chemotherapy may~     stop cancer growth.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on~     the progression free survival, i.e. the time the disease is not worsening. The aim is to~     show that the therapy with roniciclib in combination with chemotherapy prolongs the time the~     disease is not worsening in this patient population compared to patients receiving placebo~     in combination with chemotherapy.~   "
68446|NCT02161406|"~     The study hypothesis is that SC abatacept is safe and shows evidence of efficacy~     (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic~     sclerosis (dcScc) compared to matching placebo.~   "
68464|NCT02161172|"~     Patients with traumatic brain injury are likely to present with cognitive, psychological,~     emotional and behavioral problems during different periods, all of which affect patients'~     life quality seriously. The aim of this study was to assess cognitive and psychosocial~     outcome in patients with mild traumatic brain injury, and to determine the risk factors~     associated with cognitive and psychological outcome. Mini-mental state examination (MMSE),~     activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and~     mental health symptom checklist (SCL-90) were used to assess the cognitive performance and~     psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square,~     Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.~   "
68447|NCT02161393|"~     The primary aim of this study is to assess the feasibility of conducting a trial to~     investigate the effectiveness of a physical activity intervention (physical activity~     consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in~     improving physical activity in COPD.~      Objectives are:~      (i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events)~     of delivering a physical activity intervention in the COPD patient population versus~     pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and~     benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to~     investigate between and within group change in physical activity, exercise capacity, quality~     of life, self-efficacy and changes in the transtheoretical model with the physical activity~     intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a~     physical activity intervention versus pulmonary rehabilitation for patients with COPD.~      The hypothesis for this study is that it will be feasible to conduct a trial that will~     investigate the effectiveness of a physical activity intervention (physical activity~     consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation~     for improving physical activity in COPD. The study will provide important information about~     interventions designed to promote and maintain physical activity, improve patient outcomes~     and increase patients' choice relating to exercise and physical activity interventions. It~     will provide a rationale and data for an adequately powered clinical trial evaluating the~     effects of a physical activity intervention.~   "
68448|NCT02161380|"~     Hypotheses:~      The primary hypothesis being tested is that there will be no toxicity resulting in loss of~     vision to no light perception in injected eyes.~   "
68449|NCT02161367|"~     Post-operative ileus is a common complication following abdominal surgery. It results in~     abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this~     results in prolonged hospital stay and occasionally readmission following abdominal~     surgery.The etiology of post-operative ileus is multifactorial and studies evaluating~     potential treatment options are abundant, though few reliable interventions exist. This~     study proposal describes a double-blinded randomized controlled trial investigating the~     effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.~   "
68450|NCT02161354|"~     To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following~     third molar extraction.~   "
68451|NCT02161341|"~     The ocular surface is the first line of defence of the eye, it is therefore where external~     threats are sensed, and potential insults neutralised. Over the course of evolution, various~     microbes, especially bacteriae, have come to colonise the ocular surface as commensals. The~     commensals have a role to maintain the homeostasis of the ocular surface. 1 The innate~     immunity of the ocular surface is very active, and consists of active mechanisms to suppress~     inflammation 2. For example, there exist macrophages, dendritic cells, suppressor cells,~     regulatory cells, B cells, IgA, lysozyme, anti-microbial peptides and barriers against~     external agents. The normal commensals of the ocular surface maintain a basal level of~     activation of innate defence by stimulating the pattern recognition receptors on ocular~     surface epithelial cells. This normal composition of microbes is important since~     inflammation and infection will result if there is introduction of a pathogenic strain that~     overcomes the flora, or if a dominant strain secretes excessively immunogenic products, such~     as the exotoxin A of Staphylococcus which triggers marginal keratitis, a form of type IV~     hypersensitivity. The flora load of microbiome could also influence tear function as a~     higher flora load was found to be associated with increased mucin degradation 3 and reduced~     globet cell densitiy 4. Previous studies [I'm not sure which studies these are] at SERI/SNEC~     also point to the importance of microbes. For example, in dry eye patients, there is~     increased lysophospholipids in the tear, and this may contribute to inflammatory mediators~     such as arachidonic acid and other metabolites. The lysophospholipids are formed by~     phospholipase A2 reactions, and the latter may be microbial in origin. Since dry eye is a~     known inflammatory disease of the ocular surface, this is one way that microbes can~     contribute to the pathology.~   "
68452|NCT02161328|"~     The changes of local pulmonary ventilation should be registered with an electric impedance~     tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT~     cannot show changes in local ventilation due to the tracheotomy.~   "
68453|NCT02161315|"~     Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast~     Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline.~     In the past controlled clinical trials with small sample.~   "
68454|NCT02161302|"~     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)~     is effective in the treatment of chronic pelvic pain associated with endometriosis~   "
68455|NCT02161289|"~     Objectives~        1. To evaluate the acceptability and feasibility of standard HIV prevention package~          among Thai men who have sex with men (MSM)~        2. To conduct a pilot study to demonstrate the acceptability and feasibility of~          internet-based social networking, asymptomatic sexually transmitted infection diagnosis~          and treatment and pre-exposure prophylaxis strategies as potential HIV prevention~          methods among Thai MSM~        3. To use mathematical modeling to identify the most effective HIV prevention package~          optimized for Thai MSM~      Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic~     (TRC-AC), age ≥18 years old,Each participant will have a 12-month follow-up duration in the~     study.~   "
68456|NCT02161276|"~     Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.~      aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo~     Capsule to treat type II diabetes mellitus.~      ---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the~     treatment of type II diabetes~   "
68457|NCT02161263|"~     The investigators are administering a validated questionnaire looking at patient reported~     quality of life and quality of vision after LASIK surgery~   "
68458|NCT02161250|"~     Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise~     in blood glucose and insulin concentrations compared to beverage with maltodextrin (an~     easily digested carbohydrate).~   "
68459|NCT02161237|"~     Primary purpose of this study is to compare renal function between subjects receiving~     optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving~     standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf®~     over 52 weeks after kidney transplantation will also be obtained.~   "
68460|NCT02161224|"~     The effect of moderately diminished liver function on the exposure, safety and tolerability~     of a single dose of FG-4592 is studied in male and female subjects. The results are compared~     to the data gained from subjects with normal liver function.~   "
68461|NCT02161211|"~     The purpose of this study is to establish a brief CBT intervention that can largely, if not~     fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol~     use disorder treatment outcomes.~   "
68467|NCT02161133|"~     There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating~     multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant~     activity limitations and chronic cognitive problems consistent with problem-solving~     deficits. Problem-solving is considered the most complex of cognitive abilities and is what~     enables us to conduct complicated behaviors such as setting goals, sequencing and~     multi-tasking. As a result studies have found that problem-solving deficits are~     prospectively related to a greater risk of disability. Despite published reports documenting~     these problems there are no treatments that target the problem-solving deficits of GWI. This~     proposal seeks to determine whether Problem-Solving Therapy, a patient centered cognitive~     rehabilitation therapy, can reduce disability by compensating for problem-solving deficits.~   "
68468|NCT02161120|"~     The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-,~     Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than~     commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims~     to investigate patients' compliance to rye bread regimen, potential changes is gut~     microbiota and hydrogen production during the test periods (a marker of large bowel~     fermentation of poorly absorbed carbohydrates).~   "
68469|NCT02161107|"~     The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to~     subjects suffering from both grass allergy and asthma~   "
68470|NCT02161094|"~     Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the~     study seminar. Those physicians who meet the criteria of the study plan were being selected~     to participate voluntarily. From their patient's record, the physicians will recruit a total~     of 1300 patients with type 2 diabetes who meet the criteria of the Jiading Study.~      The study utilizes the social learning theory that motivation and social support are~     important to make behavioral change. The mechanism of providing incentive for patients and~     physicians will be established after the permission from the Internal Review Board of the~     hospital and will be approved by the hospital director. Physicians and their patients were~     randomly divided into 4 groups: Group 1- Physicians only; Group 2 - Patients only; Group 3 -~     Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they~     can maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. The~     forth group serves as a control and will not receive any incentive but will be provided~     diabetes education booklet and group education courses for DM control as usual. Based on the~     annual evaluation of the level of improvement on HbA1c that is a joint effort of both~     patients and physicians to achieve the targeted goal of adequate HBA1c level, the value of~     incentives will be increased accordingly. Our ultimate goal is to evaluate the effectiveness~     of incentive as an intervention tool to improve the health status of the diabetic patients.~   "
68471|NCT02161081|"~     Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most~     advantageous in obtaining information on myocardial blood flow and volume. However, dynamic~     CT perfusion technique involves higher radiation dose than static CT techniques. Patients~     have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If~     patients cannot hold their breath, anterior or inferior myocardium might be excluded due to~     limited scan coverage of a 128-slice dual-source CT scanner.~      Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation~     exposure, but also make patients more comfortable. Therefore, the investigators intended to~     propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy~     of a modified scan protocol with the current scan protocol.~   "
68472|NCT02161068|"~     This is a retrospective analysis to include demographic, clinical, biochemical, and genetic~     data that will further explore the natural history of ADPKD and assess the factors that are~     likely to be associated with the progression of disease and the incidence of complications~     including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular~     disease.~   "
68473|NCT02161055|"~     An increase in blood glucose is a common clinical symptom in patients following traumatic~     brain injury. Studies confirm that death after traumatic brain injury was not only~     associated with nerve injury, but also correlated with abnormal physiological and metabolic~     reactions. Hyperglycemia is a manifestation of physiological and metabolic disorders after~     traumatic brain injury. Traumatic brain injury induced hyperglycemia, and then aggravated~     secondary injury to the brain. Therefore, it is of important clinical significance to study~     the treatment of hyperglycemia after traumatic brain injury.~   "
68474|NCT02161042|"~     Blood transfusion is often used to treat patients with Anemia. The period of storage of~     blood products prior to use for transfusion may vary. Prolonged storage of blood products~     may result in changing their biochemistry.~      This study aims to look into whether the transfusion of old blood, which is stored for~     more than 7 days, as compared to the transfusion of Fresh blood, which is stored for less~     than 7 days, will affect endothelial function.~   "
68475|NCT02161029|"~     The purpose of this study is to determine whether the newly constructed CE (Conformité~     Européenne) marked drill biopsy instrument for flexible endoscopes can make possible~     representative biopsies of the increasing numbers of submucosal tumours in the~     gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the~     biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy~     investigations is measured in the study and compared to the amount of submucous tissue~     harvested with the existing biopsy forceps.~   "
68476|NCT02161016|"~     This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle.~     Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem~     cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed~     an informed consent, the baseline visit and examinations will be completed. Patients will be~     evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.~   "
68502|NCT02160678|"~     To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference~     listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and~     to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo)~     in the treatment of acne vulgaris.~   "
68503|NCT02160665|"~     The purpose of this study is to compare the safety and efficacy profiles of Tazarotene~     Cream, 0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence~     and to demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo)~     in the treatment of plaque psoriasis.~   "
68477|NCT02161003|"~     The problem of the incontinence imposes considerable strain on the child and their parents.~     These patients suffer from a long-life handicap and they need support and follow-up. The~     cost associated with these diseases has clearly been illustrated to be a major component in~     the healthcare spending picture, may be adding hundreds of thousands of dollars to~     healthcare cost, as well as loss of productivity in the work force. Fecal incontinence~     treatment has been a difficult challenge for surgeons for several generations until now the~     current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may~     represent a new attractive treatment option for anal sphincter lesions. Moreover,~     experimental injury of muscle of anal sphincter in rats has been successfully treated with~     stem cells injections. In this study, the investigators will shed more light on the ability~     of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients~     with fecal incontinence. It will be very useful to many Egyptian patients.~   "
68478|NCT02160990|"~     The overall goal of this study was to determine the effect of exenatide on gastric emptying,~     satiety and satiation in obese participants. The hypothesis in this study was that exenatide~     retards gastric emptying in obese patients with baseline accelerated gastric emptying.~   "
68479|NCT02160977|"~     If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover~     earlier, it will accelerate the regaining of motion control ability and motion control~     accuracy of the TKA patients. This study compared the proprioception difference of the post~     operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of~     proprioception recovery were analyzed following the two different TKA procedures and the~     advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.~   "
68480|NCT02160964|"~     Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements~     have been made in the filter design to resolve problems of structural integrity and increase~     the ability to remove the filter after longer periods of time.The FDA issued a communication~     in August 2010 advising physicians to remove retrievable filters whenever possible and~     updated that letter again in May 2014 due to concerns that these retrievable IVC filters,~     intended for short-term placement, are not always removed once a patient's risk for PE~     subsides. Known long term risks associated with IVC filters include but are not limited to~     lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter~     embolization and IVC perforation.~   "
68481|NCT02160951|"~     This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in~     Japanese patients with relapsed and/or refractory multiple myeloma for which no standard~     effective treatment options exist.~      The study consists of a dose escalation part to estimate the maximum tolerated dose and/or~     the recommended dose for expansion and a dose expansion part to further assess safety and~     preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the~     recommended dose for expansion.~   "
68482|NCT02160938|"~     The objectives of this multi-center collaborative study are to ascertain the frequency of~     specific copy number variants (CNVs) identified prenatally and to evaluate in detail through~     continued follow-up of the children the phenotypes associated with CNVs of known or~     uncertain clinical significance.~   "
68483|NCT02160925|"~     The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT~     imaging for the diagnosis of renal oncocytomas.~   "
68484|NCT02160912|"~     In this observational study insights regarding the tolerability and influence on the quality~     of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in~     patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.~      Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the~     demands of the physician and the instructions for use.~   "
68485|NCT02160899|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     ISIS-APO(a)Rx given to patients with high lipoprotein(a) for 12 weeks.~   "
68486|NCT02160886|"~     A randomized trial investigating if effects of a goal-directed task oriented intervention is~     influenced by who takes the decision and establishes the goal (the child or the parent) and~     whether establishing a goal per se influence performance and goal-achievement. The main~     hypothesis are that children's participation in the goal-setting process would positively~     influence goal achievement, children's self-identified goals would be achievable and that~     both groups would achieve goals that were the target of a goal-directed intervention.~   "
68487|NCT02160873|"~     The purpose of this study is to investigate the influence of a nighttime feeding on next~     morning running performance, hydration status, and exercise metabolism in female endurance~     athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a~     non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime~     consumption of chocolate milk, a whole food complex, will result in improved next morning~     running performance versus placebo. Secondarily, the investigators hypothesize that any~     potential positive performance outcomes from the chocolate milk treatment may be due to an~     enhanced pre-exercise hydration status or improved exercise metabolism.~   "
68488|NCT02160860|"~     Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.~   "
68489|NCT02160847|"~     The purpose of this study is to help overweight or obese children to maintain or reduce~     their body mass index (BMI) through the home-based parent training program the investigators~     developed called DRIVE. The investigators hypothesize that children from families that~     receive the DRIVE program will show greater maintenance or improvement in their BMIs than~     families who do not receive DRIVE.~   "
68490|NCT02160834|"~     Greater time spent in sedentary behaviors, independent of physical activity level, can~     increase risk of morbidity and mortality. Objective assessments indicate that bariatric~     surgery patients spend large amounts of time in sedentary behaviors. The present study is~     the first to test whether a mobile health (mHealth) approach that employs widely adopted~     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible~     and acceptable method of reducing sedentary time in these patients and other obese~     populations.~   "
68504|NCT02160652|"~     A single center single arm prospective study, assessing the outcome of ureteral~     re-implantation for malignant ureteral obstruction.~   "
68601|NCT02159391|"~     The purpose of this study is to determine whether the Brief Motivational Interview will~     produce a significantly reduction in risk behavior than usual treatment 3 months after~     discharge from hospital in people who have survived a traumatism.~   "
68492|NCT02160808|"~     Pancreatic leaks complicate pancreatic resection in approximately 20% of cases. The~     pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic~     surgery. Unfortunately, despite recognition of this problem and multiple operative~     techniques proposed to prevent this complication, leaks continue to represent a major cause~     of morbidity for patients undergoing pancreatic surgery. Treatment of leaks often requires~     nutritional support with total parenteral nutrition to diminish the leak in addition to~     invasive interventions to contain the leak with drains, stents or in severe cases,~     reoperation. Experiential data suggest that intra-operative infusions of secretin, a~     naturally occurring hormone that stimulates bicarbonate release from the pancreas, following~     resection but just prior to abdomen closure, may identify a leak if present. If secretin can~     demonstrate evidence of leaking intra-operatively, the pancreatic duct leak may be able to~     be fixed prior to abdominal closure. The investigators aim to determine if giving an~     intra-operative infusion of secretin will allow for identification and treatment of leaks~     after pancreatic reconstruction and prior to abdominal closure, leading to a reduction in~     the rate of pancreatic anastomotic leaks requiring intervention. The investigators will~     perform a double-blind, randomized pilot study of 176 patients undergoing pancreatic~     resection (pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical~     Center. 88 of those patients will receive an intra-operative secretin infusion prior to~     abdominal closure and 88 will receive a saline placebo. Our primary outcome of interest will~     be the rate of pancreas duct leaks in each group as measured by the amount of amylase~     present in the surgical drains 5 days following surgery.~   "
68493|NCT02160795|"~     Background:~      - Pregnant women are encouraged to take the vitamin folate. It helps prevent some birth~     defects. Children of mothers who take it also have less risk of some cancers. Between 1993~     and 1995, some women in China took the vitamin daily before and during early pregnancy.~     Another group did not. This study will follow up on children born to both sets of women.~     (The children were born between 1994 and 1996.) Researchers will use these data to study the~     link between folate and cancer in infants and children.~      Objective:~      - To see if folate may reduce childhood cancer if women take it every day before and during~     early pregnancy.~      Eligibility:~      - Mothers who took part in a Chinese folic acid study between 1993 and 1995 and their~     offspring.~      Design:~      - Mothers of children in the study will sign a consent form. The form lets the researchers~     review the child s medical history. They may also review data about their cancer diagnosis.~     The children will also sign a form.~   "
68494|NCT02160782|"~     This is a long-term, open-label study with a double-blind, placebo-controlled, randomized~     drug withdrawal period in children with ALGS designed to evaluate the safety and efficacy of~     LUM001. The study is divided into 5 parts: a 6-week open-label, dose escalation period, a~     12-week stable dosing period, a 4-week randomized, double-blind, placebo-controlled drug~     withdrawal period, a 26-week long-term stable dosing period, and an optional 52 week~     follow-up treatment period for eligible subjects who choose to stay on treatment with~     LUM001. Subjects' participation in the optional follow-up treatment period will continue~     until the first of the following occur: (i) completion of 52 weeks of additional treatment~     (Week 100), or (ii) in the event that a new study of LUM001 opens to enrollment.~   "
68495|NCT02160769|"~     The investigators study aims to capture the objective effects of pterygium surgery on tear~     layer lipid thickness and the tear layer.~      Previous objective studies of the tear film has been limited to corneal staining grading,~     tear break up time and Schirmer's test which have been shown to poor to moderate~     repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not~     previously been explored. With the LipiView Ocular Surface Interferometer, the investigators~     have the ability to assess the optical coherence interference pattern produced by light~     reflected off the tear film in a safe and non-invasive manner. Software analysis of the~     image then measures the tear LLT which can be used to objectively quantify the diagnosis of~     lipid-deficient dry eye.~   "
68496|NCT02160756|"~     The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a~     drug enters and leaves the blood and tissues over time) and relative bioavailability (the~     extent to which a drug or other substance becomes available to the body) of JNJ-56021927,~     when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule~     formulation (reference) in healthy male participants under fasted conditions at a single~     dose of 240 milligram (mg).~   "
68497|NCT02160743|"~     This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination~     of CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) in healthy male subjects~   "
68498|NCT02160730|"~     The investigators hypothesize that R-roscovitine will suppress pituitary corticotroph tumor~     ACTH production and normalize urinary free cortisol levels in patients with Cushing disease.~     To date, R-roscovitine has been evaluated in several Phase I and II studies and has shown~     early signs of anti-cancer activity in approximately 240 patients.~   "
68499|NCT02160717|"~     Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome~     have abnormalities in glucose metabolism which can lead to diabetes. The current screening~     guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood~     sugar once a year. The objective of this study is to determine if there are abnormalities in~     glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study~     hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin)~     is more prevalent in girls with Turner Syndrome compared to healthy controls.~   "
68500|NCT02160704|"~     This is an exploratory, single center, randomized, parallel, double-blind placebo- and~     active-controlled trial in adult males ages 18 to 35 years of age who have male infertility~     of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment~     groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half~     of the men will receive a placebo (non-active pill) for 16 weeks. This study will last~     approximately 4 months and involve up to 7 visits.~      The purpose of this study is to determine the effect the Androxal on sperm production.~   "
68501|NCT02160691|"~     The purpose of the study is to determine if a new device, called the Anxiety Meter, improves~     recognition and management of psychological arousal associated with anxiety in children with~     ASD.~   "
78278|NCT02032784|"~     Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or~     ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.~   "
68505|NCT02160639|"~     Improving diabetes social support is associated with health improvement benefits. This study~     is a prospective randomized controlled trial comparing the effects of telephone-based~     diabetes self-management support (DSMS) compared with usual care, which includes diabetes~     self-management education (DSME), during a 1-year period. It will determine whether this~     specific model for providing on-going support to people with diabetes will better enable~     them to maintain the engagement in self-care behaviors, clinical improvements and~     diabetes-specific knowledge gained during the course of diabetes self-management education.~   "
68506|NCT02160626|"~     The main objective of this study is to evaluate the dose-response relationship of two~     concentrations of A-101 solution when applied to individual seborrheic keratosis (SK)~     lesions (target lesions) compared with a matching A-101 Solution Vehicle.~   "
68507|NCT02160613|"~     The study hypothesis:~      Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?~   "
68508|NCT02160600|"~     To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass~     evaluation in terms of appropriateness of treatment received after diagnosis. To determine~     SBDECT diagnostic accuracy.~   "
68509|NCT02160587|"~     This is a safety study to determine the skin sensitization potential of ZuraPrep™ and~     ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of~     human subjects. Indications of both sensitization and skin irritation will be evaluated.~   "
68510|NCT02160574|"~     This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™~     and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human~     subjects.~   "
68511|NCT02160561|"~     Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS)~     and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The~     cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used~     supine position might also contribute to this shunt. Reports indicate that obese patients~     may be more likely to develop dorsal atelectasis than non-obese patients.~      The investigators hypothesized that opening the body position angle at the waist from a~     typical head of bed at 30 degrees to one similar to a more upright reverse trendelenburg~     position, would alter the position of the diaphragm downward, allowing for improved aeration~     of lung bases. Thus, the investigators examined the upright body positioning in mechanically~     ventilated patients with ARDS primarily by evaluating for effects on oxyhemoglobin~     saturation (O2sat), Tidal Volume (TV) and Respiratory Rate (RR).~   "
68512|NCT02160548|"~     We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine~     alone in OP poisoned patients. We propose to compare the effect of two stat doses of~     nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic~     patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning~     with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary~     outcome will be oxygen saturation's over the following 60 min during resuscitation.~     Secondary outcomes will include atropine dose administered, speed to stabilization,~     aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome~     will result in design of a large definitive phase III study.~   "
68513|NCT02160535|"~     This study will provide evidence on whether the use of an FDA-approved drug therapy for the~     treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of~     chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the~     head, or a fall, or a motor vehicle accident, or some other traumatic event.~   "
68514|NCT02160522|"~     Our study will measure the pressure of the endotracheal tube cuff in intubated patients in~     the emergency department.~   "
68515|NCT02160509|"~     1. Purpose~             -  This study aims to evaluate the feasibility of iPhone based telementoring for the~               ultrasonography.~        2. Methods~             -  Study Design: Prospective observational study~             -  Study Setting: Urban academic ED of tertiary care teaching hospital~             -  Study period: July, 2014 ~ December, 2014 (six months)~             -  Study participants: Of the patients who need to undergo ultrasonography in the ED,~               those who are agreed to participate in this study are enrolled.~        3. We hypothesize that the iPhone based real time tele-diagnosis by remote expert would~          not be different from the diagnosis via his/her direct ultrasound examination.~   "
68516|NCT02160496|"~     The objective of the study is to assess the effect of diets with different protein~     composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on~     body weight and lipid profile in overweight and obese women. A dietary intervention is~     carried out during 3 months in 90 women who are individually randomized to an hypocaloric~     diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35%~     carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat~     and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or~     shoulder of lamb) by providing up to 15 different recipes to participants to use them as~     part of the diet. At the beginning of the study, after 6 weeks and at the end of the~     intervention, the following parameters are determined: anthropometric (weight, waist~     circumference, body mass index and body composition), blood pressure, dietary (72-hours~     dietary registry) and exercise assessments and biochemical analysis (total cholesterol,~     triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron,~     transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months~     visit, participants will be advised to follow the prescribed diets during the next 3 months.~     Monitoring visits with the nutritionist will not be performed. A follow-up visit will be~     done after 3-months of end of intervention (at 6-months after beginning the study) to assess~     the long-time efficacy on main endpoint of each diet. In this visit only anthropometric~     parameters (weight, waist circumference, body mass index and body composition) will be~     determined.~   "
68517|NCT02160483|"~     Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin~     labelling, functional connectivity, diffusion tensor imaging and magnetic resonance~     spectroscopy.~   "
68518|NCT02160470|"~     This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the~     addition of a brief fear retrieval trial prior to treatment, and the use of compound~     extinction during treatment. The goal of the study is to determine whether these behavioral~     techniques enhance the efficacy of exposure therapy, one of the most empirically supported~     treatments for anxiety disorders.~   "
68520|NCT02160444|"~     Investigation is designed to determine whether the gold standard for treating anxious youth~     is enhanced by teaching parents to become their anxious child's CBT coach. Children (7-17~     years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety~     Disorder are treated with a combination of the Coping Cat Program and a parent-training~     intervention that is designed to teach the child's parents the same cognitive and behavioral~     skills that the child is learning and how to help their child to complete exposure~     activities. The research methods are parallel to those used in the CAMS study so that this~     data can be merged with that data set to evaluate the relative efficacy of the enhanced~     intervention.~   "
68521|NCT02160431|"~     The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.~   "
68522|NCT02160418|"~     In this randomized controlled study, the investigators compare two classes of behavioral~     approaches to change habits and health outcomes with an application to dental health:~     cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid~     to correctly answer health-related quizzes. Under behavioral incentives subjects earn money~     for making healthy choices. The investigators apply these incentives to toothbrushing, a~     daily health-related behavior critical to the prevention of dental caries and periodontal~     disease, two high-burden conditions among US adults.~   "
68523|NCT02160405|"~     Nutritional deficiencies can lead to a number of health problems in children. In Latin~     America and the Caribbean countries, are registered so much problems of insufficient~     ingestion of food as of imbalances in the composition of the diet. These latter are~     expressed in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major~     health burden in developing countries. Being the globally's leading risk factor for disease~     and death, with hundreds of millions of pregnant women and young children particularly~     affected.~      Justification: In Nariño, Colombia higher levels of malnutrition are presented with respect~     to country, just as micronutrient deficiency in children 1 to 4 years is higher than the~     national average. Most of these households are poor families with restrictions on access to~     food sources of these micronutrients, which is reported in a consumption of fruits,~     vegetables, milk products and meat, less than the national average. In this place is~     developing a project that aims to improve potato in higher yield, nutrition and resistance,~     for contribute to increase food security of native communities.~      Objective: Evaluate the effect on iron levels generated by the inclusion of native potato in~     the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the~     municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia~      Methods:~      Design: A cluster randomized controlled trial. Open label Setting: 6 clusters,~     municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will~     be randomly assigned to 2 groups: the treatment group that receives native potato, and the~     control group that receives traditional potato, that will be include in the usual~     Institution meal Participants: children from 2 to 5 years, beneficiaries of programs in~     institutional modality of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres,~     Cumbal and Pasto.~      Main outcome measures: serum ferritin and transferrin levels~      The study was conducted in the form of institutional programs ICBF, in the municipalities of~     Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based~     on the changes that occur over time after surgery in the mean values (μ) of serum ferritin~     in the treatment group compared with the control group. A sample size of 212 children were~     calculated. The study has been presented and approved by the Ethics Committee of the Faculty~     of Medicine of the National University of Colombia and the Institutional Review Board of the~     participating institution. All parents of participating children must sign a written form to~     accept the voluntary participation of their child in the study.~   "
68524|NCT02160392|"~     The female upper genital tract is a unique compartment involved in HIV pathogenesis.~   "
68525|NCT02160379|"~     This is a cross-sectional study enrolling~        -  11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric~          Bypass (RYGB)~        -  11 age- and weight-matched female subjects~        -  10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will~          be performed in each participants in basal conditions (after an overnight fast) and~          after ingestion of a standard meal~        -  electroencephalographic recordings of visually evoked potential after presentation of~          food- or non-food pictures~        -  plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones~          (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP),~          Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of~          this observational study are~        -  to evaluate the effects of RYGB on brain perception of food related visual stimulation~        -  to search for relationships between RYGB effects on brain responses and~          gastro-intestinal hormone secretion~   "
68526|NCT02160366|"~     The goal of this laboratory research study is to collect and analyze treatment, molecular~     profiling and biomarker data. The results of the data analysis will be used to better~     understand how to characterize tumors and identify therapies that may be tailored to~     individual patients and to identify and/or predict side effects that may occur and/or~     predict which therapies may be best for participants. Research may also be done on your~     existing tissue to identify new biomarkers.~   "
68527|NCT02160353|"~     The role of this study is to focus on the potential role of abiraterone acetate in~     treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring~     combined hormonal therapy and radiotherapy.~   "
68528|NCT02160340|"~     The purpose of this study is to evaluate the prevalence of vitreomacular adhesion (VMA) in~     patients 40 years and older using Spectral Domain Optical Coherence Tomography.~   "
68529|NCT02160327|"~     The specific aims of the the investigators studies are as follows:~        -  To collect the tear samples from patients with different ocular surface disorders,~          including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).~        -  To evaluate the differential expression of tear cytokines and pH values between~          different ocular surface disorders.~        -  To collect the surgical conjunctival specimens from the patients with SLK and~          conjunctivochalasis.~        -  To evaluate the factors inducing mast cell migration and how mast cell is activated in~          SLK via surgical specimens and cultivated fibroblast.~   "
68530|NCT02160314|"~     This study will evaluate the safety of the pessary device by objective evaluation of vaginal~     wall integrity and subjective assessment of comfort during in-use conditions.~   "
68531|NCT02160301|"~     The study is a prospective, randomized, open-label comparison of a multimodal regimen and a~     standard, narcotic-based regimen for postoperative pain control in patients undergoing~     surgery for an operatively indicated, isolated extremity fracture. The investigators will be~     measuring pain levels, narcotic use, patient satisfaction, patient reported function,~     adverse events and fracture union. The investigators hypothesize that this multimodal~     regimen will lead to improved pain, less narcotic use and improved satisfaction as compared~     to the standard regimen.~   "
68532|NCT02160288|"~     The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will~     improve symptoms of constipation in obstructed defecation syndrome (ODS).~   "
79760|NCT02013453|"~     The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs)~     to standard chemotherapy can improve progression free survival in patients with head and~     neck cancer.~   "
68533|NCT02160275|"~     In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This~     system for automated control of blood glucose in patients with type 1 diabetes was tested in~     the clinical research center as well as at the home of the patients. Glucose control with~     automated closed loop control was comparable to patient-managed open loop control.~      The closed loop system has been further developed and miniaturized (from backpack to~     smartphone size) in order to interfere as little as possible with daily patient life. The~     aim of this trial is to assess the efficacy of the new prototype at the home of the patient.~     It is hypothesized that the closed loop system provides better glucose control than standard~     open loop therapy.~   "
68534|NCT02160262|"~     To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with~     Attention Deficit Hyperactivity Disorder (ADHD)~   "
68535|NCT02160249|"~     The purpose of this study is to determine whether community-based rehabilitation plus~     facility-based care is superior to facility-based care alone in reducing disability related~     to schizophrenia in rural Ethiopia.~   "
68536|NCT02160236|"~     In this study the investigators aimed to compare of postoperative analgesic effects of~     intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.~   "
68537|NCT02160223|"~     Incomplete recovery of neuromuscular function after surgery can lead to respiratory~     complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory~     complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.~      The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence~     of respiratory complications and cost in patients undergoing surgery for OSA~   "
68538|NCT02160210|"~     This study is the evaluation of ultrafine endoscope (with small caliber and turning radius~     )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in~     this trial.~   "
68539|NCT02160197|"~     The purpose of this study is to examine the effect of variations in practice, ranging from~     early functional rehabilitation to complete immobilsation in post operative patients with~     ankle fixation following fractures. The primary goal of any post-operative regimen is to~     attain full weight-bearing and as close to pre-injury levels of activity as soon as~     possible.~      We seek to establish the effect on (1) functional outcome, (2) complication rates and (3)~     time to return to work of three different approaches to rehabilitation after ankle fracture~     fixation in order to produce a standardised, evidence-based guideline for our unit. We also~     aim to perform a cost analysis for each approach.~   "
68540|NCT02160184|"~     The aim of the study is to assess the efficacy and safety of a closed-loop system consisting~     of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control~     System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and~     post-breakfast periods. Intervention will be to apply the automated closed-loop system by~     administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a~     continuous glucose measurement (CGM) system.~   "
68541|NCT02160171|"~     A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure~     Detection: ANSeR~   "
68542|NCT02160158|"~     The purpose of this study is to evaluate the relative bioavailability of 2 new~     bead-in-capsule formulations compared to the commercial extended-release formulation (both~     fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on~     the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).~   "
68543|NCT02160145|"~     The purpose of the study is to determine whether tolvaptan is effective and safe for the~     treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney~     disease (ADPKD)~   "
68544|NCT02160132|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     effect and security of steroids therapy for patients of IgA nephropathy with active~     pathological changes,including crescents,necrosis and microthrombus.~   "
68545|NCT02160119|"~     Several studies seem to indicate that emotional attention and change-related attention are~     impaired in ASD. The goal of this study is to identify the relationships between those two~     types of automatic attention in visual and auditory modalities in subjects with ASD compared~     to healthy controls and also, over the course of development (children, adults). In order to~     achieve this goal, the investigators will use complementary techniques (EEG and MRI-based~     techniques (fMRI, DTI)).~   "
68546|NCT02160106|"~     The phase I dose escalation study will investigate the safety, tolerability, and~     pharmacokinetics of the TGF-β pathway inhibitor TEW 7197 in subjects with advanced,~     refractory solid tumors.~   "
68547|NCT02160093|"~     Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in~     geriatric outpatients cooperated with the Department of Family Medicine, Department of~     Geriatrics and Gerontology, National Taiwan University Hospital, this study will be~     conducted to examine the impacts of the specific co-morbidities and ageing psychology on the~     outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be~     reviewed after frailty being considered in the elderly with co-morbidity condition. In~     addition, the conceptual framework and corresponding measuring instrument of mental~     frailty will be expected developed.~   "
68548|NCT02160080|"~     End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for~     liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver~     transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani~     et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver~     transplantation.(Bzowej et al., 2011)~      Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver~     disease patients awaiting for liver transplantation annually. If the HCV viral load can be~     significantly reduced or sustained virologic response (SVR) can be achieved by triple~     therapy with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before~     liver transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we~     can reduce the risk of early fibrosis progression in the liver graft, and hopefully,~     improving graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani~     et al, 2011).~      We aim to conduct an prospective, open label, single arm study. This study design is single~     arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC)~     triple therapies before liver transplantation for patients with detectable HCV RNA. The~     total number of patients would be around 20 cases included in the study and all of them will~     take Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The~     experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus~     Ribavirin. Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will~     be used for at least 16 weeks or maximal 44 weeks before transplantation. Normal practice~     based on the treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver~     transplant center will be done before enrollment. Patients will be monitored for all the~     efficacy and safety endpoints during the treatment period. HCV RNA will be checked at time~     of transplant. Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12~     months after liver transplantation.~   "
68552|NCT02160028|"~     Information about the effectiveness of treatment has been found to reduce pain, termed~     placebo analgesia. In this study it will be investigated whether this finding translates to~     the dental clinic. It will be investigated whether information that suggested that minimal~     pain will be experienced during filling therapy, can reduce the pain associated with that~     procedure compared to a group that receives standard information. All patients will receive~     the same amount of anesthesia and similar procedures during filling therapy. It is predicted~     that extended information should reduce pain, and that the reduction in pain should be~     associated with a reduction in stress.~   "
68553|NCT02160015|"~     This phase I trial studies the side effects and best dose of lenalidomide when given~     together with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia~     or small lymphocytic lymphoma that has come back, has not responded well to prior~     treatments, has spread to other parts of the body, or cannot be removed by surgery.~     Biological therapies, such as lenalidomide, use substances made from living organisms that~     may stimulate or suppress the immune system in different ways and stop cancer cells from~     growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, may find cancer cells and~     help kill them. Giving lenalidomide together with ibrutinib and rituximab may kill more~     cancer cells.~   "
68554|NCT02160002|"~     The objective of this proposal is to evaluate whether weaning from an incubator to a crib at~     lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay~     among moderately preterm infants.~      The hypothesis of this study is that length of hospital stay (from birth to discharge) will~     be decreased among moderate preterm infants weaned from an incubator to an open crib at a~     lower versus higher weight, 1600g vs. 1800g.~   "
68555|NCT02159989|"~     This phase I trial studies the side effects and best dose of sapanisertib and~     ziv-aflibercept in treating patients with solid tumors that have come back and have spread~     to another place in the body or cannot be removed by surgery. Sapanisertib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Ziv-aflibercept may stop the growth of solid tumors by blocking the growth of new blood~     vessels necessary for tumor growth. Giving sapanisertib with ziv-aflibercept may kill more~     tumor cells.~   "
68556|NCT02159976|"~     1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and~          to establish more effective first-line regimen for the eradication of Helicobacter~          pylori in Korea.~        2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of~          functional dyspepsia~   "
68557|NCT02159963|"~     The investigators aim to investigate the effect of high-intensity training in patients with~     facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise~     without muscle damage.~   "
68558|NCT02159950|"~     This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod~     works in treating patients with hormone-resistant prostate cancer that has spread to other~     parts of the body. Vaccines made from a person's tumor cells and white blood cells may help~     the body build an effective immune response to kill tumor cells. Tasquinimod may stop the~     growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor~     growth. It is not yet known whether sipuleucel-T is more effective with or without~     tasquinimod in treating prostate cancer.~   "
68559|NCT02159937|"~     The purpose of this study is to evaluate in vitro the potential of peptides, to modify,~     phenotypically and functionally, the monocyte-derived dendritic cells of patients with~     metastatic cancer.~   "
68560|NCT02159924|"~     This study aims to investigate posture-mobility associations in the upper quadrant by means~     of smartphone measurements~   "
68561|NCT02159911|"~     A randomized, double blind study to compare 200 and 400 mcg misoprostol for cervical~     preparation before hysteroscopy.~   "
68562|NCT02159898|"~     This is a prospective, single blinded, randomized study of EndoMAXX EVT Fully Covered~     Esophageal Stent with Valve for the treatment of malignant strictures of the lower~     esophagus. The purpose of this study is to evaluate improvement of dysphagia due to~     esophageal stricture with EndoMAXX EVT Fully Covered Esophageal Stent with Valve~     (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference~     device).~   "
68563|NCT02159885|"~     Automatically titrating continuous positive airway pressure (APAP) and continuous positive~     airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea.~     There is a growing body of evidence that suggests that early patient education and~     intervention may improve adherence with positive airway pressure. The investigators plan a~     prospective, randomized trial to see if telemonitoring in the first several weeks of PAP~     therapy improves adherence following 3 months of treatment.~   "
68564|NCT02159872|"~     The goal of this clinical research study is learn if omacetaxine can help to control MDS.~     The safety of this drug will also be studied.~   "
68565|NCT02159859|"~     The purpose of this study is to determine the amount of ertapenem in the blood over time~     between hemodialysis session.~   "
68566|NCT02159846|"~     The aim of this study was to evaluate the effects of mixed herbs as ad-on therapy on blood~     sugar and lipid profile of patients with established T2DM. A total 20 patients were~     consented and were equally divided into the Control and the Test groups and was fed with the~     Placebo or mixed herbs 4 g daily for 30 days, respectively. Blood samples were collected~     before and at the end of the feeding period and analyzed for the parameters namely Fasting~     Blood Sugar (FBS), 2 hours post prandial (2HPP) Glycosylated Hb (HbA1c) and Lipid Profile.~     The collected data was analyzed using SPSS Statistical Software version 12.~   "
68567|NCT02159833|"~     The investigators will conduct low-dose intranasal allergen challenges on~     children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut.~     The data will be used to determine the safety and potential utility of intranasal food~     challenges in the diagnosis of food allergy.~   "
68651|NCT02158741|"~     The overall purpose of this research is to examine and compare the effectiveness and costs~     of a community-based intervention to support self-management with usual primary care for~     older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family~     caregivers. Once the study is complete, the investigators will be able to determine if there~     is any measurable difference in self-care management between usual care plus the~     intervention versus usual care alone.~   "
68568|NCT02159820|"~     Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer~     death in women. Most patients are typically diagnosed with advanced-stage disease.~     Platinum-paclitaxel regimen has been widely adopted as a standard first-line treatment for~     advanced ovarian cancer. Multiple collaborative randomised phase III trials evaluating the~     addition of a third chemotherapy agent, maintenance therapy or alternative taxanes failed to~     demonstrate significant improvements over a standard carboplatin/taxane doublet.~      Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of~     preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug~     Administration. Past trials of these with high doses, i.e., the use of maximal tolerated~     dose, for patients with solid tumors showed a low therapeutic index, due to extreme~     toxicities that have probably confounded the ability to document the true clinical response.~      Low dose DNA demethylation agent decitabine (DAC) can resensitize the therapeutic indexes of~     resistent ovary cancer cells in vivo and in vitro.~      The investigators hypothesized that DAC-triggered epigenetic reprogramming of tumor cells~     and possible immune cells could induce pronounced long-dated clinical effect by~     chemosensitization- and immunopotentiation-driven maximal eradicating roles on the~     minimal/residual lesions in primary patients with poor prognosis.~   "
68569|NCT02159807|"~     The purpose of this study is to determine what dose of medication administered through a~     combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of~     side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor~     floor (depending on the physician preference) but the idea is to quantify safety, efficacy~     and side effects for each of these doses.~   "
68570|NCT02159794|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
68571|NCT02159781|"~     The investigators plan to recruit 40 healthy patients referred to the unit of~     Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.~      treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions~     and motivation.~      Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.~      Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment~     has an affect on saliva components.~   "
68572|NCT02159768|"~     The Airtraq is a battery powered single use optical laryngoscope with a channel to hold and~     guide the tracheal tube into the trachea. It enables tracheal intubation in patients with~     normal and difficult airways, by enabling laryngoscopy without neck movement. As a single~     use device, it is cost effective to have these placed in emergency equipment kits, and for~     use by emergency and military personnel.~      However, it does have several limitations. The Airtraq requires the user to place his/her~     eye to the eyepiece in order to see the advancement of the laryngoscope and the tracheal~     tube, which may be difficult if the patient is on the ground or in emergency scenarios. Only~     the user can see through the eyepiece and any assistants are unable to view the larynx, this~     makes it difficult for assistants to help the operator.~      Many handphones now incorporate high quality cameras. In this study, we will evaluate the~     effectiveness of using the iPhone to aid laryngoscopy with the Airtraq optical laryngoscope~     during laryngoscopy and intubation in 30 patients presenting for elective surgery under~     general anaesthesia. We have manufactured an attachment that fits over the eyepiece of the~     Airtraq, to hold an iPhone to the eyepiece. This will enable to operator and assistants to~     simultaneously view the insertion of the Airtraq, view the larynx and view the passage of~     the tracheal tube into the trachea.~   "
68573|NCT02159755|"~     This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in~     treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the~     drug.~   "
68574|NCT02159742|"~     From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic~     diseases both on prospective research protocols (for head and neck cancer, pleural~     malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for~     FDA approved and off label or compassionate exemption indications (neoplasms of the skin,~     bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize~     quality of life and organ function while minimizing the chance of tumor recurrence. As such,~     we would like to retrospectively review the treatment parameters of all patients who~     undergo/underwent PDT (including operative notes and photodynamic therapy records) and~     treatment outcomes (including all organ functions, performance status, tumor recurrence,~     laboratory values and any other data present in the routinely documented follow up visits).~     For patients who have died or were lost to follow-up prior to initiation of this study, a~     retrospective review of available data will be performed. For patients who are still being~     actively followed after PDT or who receive PDT after the initiation of this study, informed~     consent will be obtained for obtaining continued follow-up data prospectively and any~     previous data will be collected retrospectively.. These subjects will continue to receive~     care from their current physicians according to standard medical practice and no attempt~     will be made to alter the types of follow-up, radiologic or other diagnostic studies or~     medical treatment as a result of enrollment in this study. All data will be de-identified~     and added to our already existing PDT treatment outcome databases for outcomes analysis,~     quality improvement and reporting of results in abstract and manuscript forms.~   "
68575|NCT02159729|"~     Long-term follow-up study of subjects who completed Kythera-sponsored trials of ATX-101~     (06-03, 07-07, 09-15)~   "
68576|NCT02159716|"~     Phase I study to establish safety and feasibility of intravenously administered lentiviral~     transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose~     escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian~     cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort~     3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we~     will dose deescalate by 10-fold.~   "
68652|NCT02158728|"~     To collect SVT data for developing and testing sensing and detection algorithms for a~     subcutaneous ICD.~   "
79790|NCT02013050|"~     To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment~     for the treatment of head and neck cancer.~   "
68578|NCT02159690|"~     This study investigates the pathologic effects of the combination of enzalutamide,~     abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to~     prostatectomy in men with localized prostate cancer.~      Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR~     as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate~     inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is~     a 5-alpha-reductase inhibitor which blocks conversion of testosterone to~     dihydrotestosterone. Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to~     GnRH receptors on the pituitary gland thus suppressing testosterone release from the testes.~      Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate,~     dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable~     pathologic changes after 12 weeks of therapy.~   "
68579|NCT02159677|"~     The purpose of this study is to assess neck and low back pain using Electrical Impedance~     Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the~     diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and~     associated software of ease-of-use and interpretation by PCPs and staff.~   "
68580|NCT02159664|"~     Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to~     assess the changes in upper airways obstruction levels before and after Didgeridoo practice~     in moderate OSA patients.~   "
68581|NCT02159651|"~     This study is to evaluate the safety and the efficacy of Prograf in patients with~     interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical~     setting.~   "
68582|NCT02159638|"~     Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1~     diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides~     a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level~     by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose~     levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels~     estimated by CGM with measured glucose levels in plasma. In the current study, we will~     compare the accuracy of the 2 CGM systems available on the market for clinical use in~     patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness,~     safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic~     patients.~   "
68583|NCT02159625|"~     Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of~     cardiovascular (CV) morbidity and mortality than do the general population and many~     populations with other chronic diseases. This exceptional risk is explained in part by known~     risk factors, such as diabetes, hypertension, and other uremia-related factors, including~     vascular calcification and stiffness, autonomic dysfunction, and a high burden of~     circulating inflammatory mediators. Recent studies suggest that blood pressure variability,~     especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV~     events. Studies have also shown that the use of IAB is capable of improving cardiovascular~     function for avoiding or minimizing the development of an orthostatic hypotensive episode~     (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes~     patients and children with orthostatic intolerance, and post-dialytic orthostatic~     hypotension (PDOH).~      The investigators propose a study to examine the use of an abdominal compression elastic~     support (ACES) to prevent the development of IDH in patients who are known to be prone to~     these episodes. The ultimate goal is to facilitate more effective and safer dialysis~     therapy. The ACES has a configuration that is similar to a back-support work belt or an~     inflatable abdominal band (IAB). All of these devices are wrapped around to compress the~     abdomen at the waist.~   "
68584|NCT02159612|"~     An investigation of disease progression in adult danish patients with facioscapulohumeral~     muscular dystrophy. The disease progression is followed for a year with two test-days,~     including functional muscle tests and a MRI scan of muscles in the back and legs.~   "
68585|NCT02159599|"~     This is an open label randomized clinial trial to evaluate the treatment with~     darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with~     darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or~     abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.~   "
68586|NCT02159586|"~     The objective of this study is to determine if Gastric Electrical Stimulation may influence~     vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.~   "
68587|NCT02159573|"~     The primary objective of the study is to evaluate relapse activity, as measured by the~     proportion of participants relapsed at 12 months, in participants with relapsing-remitting~     multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in~     the real-world setting. The secondary objective is to further evaluate relapse activity,~     defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid~     use, during the first year of Tecfidera treatment following transition from Tysabri~     treatment.~   "
68588|NCT02159560|"~     The investigators hypothesize that multi-port thoracic epidural catheters will provide~     superior pain relief when compared to uniport catheters for post-surgical patients.~   "
68589|NCT02159547|"~     H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in~     emergency department.~      H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine~     attack in emergency department.~   "
68590|NCT02159534|"~     Background : Brain vulnerability is particularly marked in preterm neonates and has~     long-term consequences. Unlike lesions affecting other organs, those that affect the brain~     can currently not 'be repaired' by producing new cells. However, exeprience-driven brain~     plasticity allows the brain to reorganise its connections to compensate (at least partially)~     the effects of an injury.~      Purpose : To evaluate the influence of NOBEPPI sensorimotor stimulation on cognitive, motor~     and language development at 18 months of corrected age in children born <32 weeks' gestation~     or with birth weight <1500 g.~   "
68591|NCT02159521|"~     To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic®~     Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome~     and chronic venous occlusion.~   "
68663|NCT02158585|"~     This double-blinded study evaluates the frequency of vertigo attacks and the quality of life~     of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo~     or lamotrigine.~   "
68593|NCT02159495|"~     This phase I trial studies the side effects and the best dose of genetically modified~     T-cells after cyclophosphamide in treating patients with relapsed or refractory acute~     myeloid leukemia. An immune cell is a type of blood cell that can recognize and kill~     abnormal cells in the body. The acute myeloid leukemia-specific immune cell product will be~     made from patients' blood cells. The immune cells are changed by inserting additional pieces~     of deoxyribonucleic acid (DNA) (genetic material) into the cell to make it recognize and~     kill acute myeloid leukemia cells. Placing a modified gene into white blood cells may help~     the body build an immune response to kill cancer cells.~   "
68594|NCT02159482|"~     This research study is for people who have previously received cancer vaccines. The~     investigators are testing a form of therapy known as interferon alfa-2a, which is~     commercially available as the drug Roferon®-A, to see if it can be used to help boost the~     effects of the cancer vaccine and help the immune system attack the cancer.~      It is believed that the body's immune system can attack tumor cells and kill them. This is~     thought to be due to immune cells called T cells which can recognize special proteins on the~     surface of tumors as a signal to fight the cancer. However, the vaccine may not work very~     well if the protein signal is too weak for the T cells to find your tumors. The~     investigators think that interferon alfa-2a can signal the cancer cells in the body to make~     more proteins that may allow the T cells to recognize and kill the cancer cells better.~   "
68595|NCT02159469|"~     Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously~     using an auto-injector~   "
68596|NCT02159456|"~     1. Nutritional support during critical illness is important to improve the clinical~          outcome of patients. Recently, the apply of early enteral nutrition is recommend in~          critically ill patients on basis of data that enteral nutrition can be helpful to~          prevent the hospital-acquired infections.~             -  However, in critically ill patients, the smooth progress of nutritional support is~               often hindered by gastrointestinal intolerance, underlying clinical condition, and~               temporal necessity of procedure or operation.~             -  Continuous feeding method, compared with intermittent feeding, is expected to~               reduce the risk of gastrointestinal intolerance, and improve the nutritional~               support, but this hypothesis is not supported by appropriate evidences.~        2. We will elucidate to compare the efficacy and safety of the continuous feeding method~          in critically ill patients, compared with the intermittent feeding method.~             -  Prospective, randomized controlled study~             -  Primary outcome: the achievement rate of target nutritional goal within 7 days~               after the start of enteral nutrition~             -  Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality,~               frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of~               mechanical ventilation~   "
68597|NCT02159443|"~     Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital~     (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their~     surface. Sometimes the human body will make an antibody to the therapeutic antibody (like~     hu14.18K322A) that is being given for treatment. These are called human anti-human~     antibodies (HAHA). When testing for HAHA in a previous cohort of patients who received~     hu14.18K322A, it was found that some patients tested positive for high levels of an antibody~     before receiving hu14.18K322A or any other anti-GD2 antibody. In this study, investigators~     would like to know more about the nature of this pretreatment antibody, how often is it~     present, and if in the laboratory it increases the killing of tumor cells.~      OBJECTIVES:~        -  To determine whether pretreatment anti-therapeutic antibodies (PATA) represent~          antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2~          antibody hu14.18K322A~        -  To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro~   "
68598|NCT02159430|"~     Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder~     (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1~     esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general~     population. From this period the link between HAE and psychiatry was interrupted, however~     genetic issues could not comprehensively explain the clinical evolution of the disease.~     Clinical studies show an evident gap between genotype and phenotype of HAE. For this still~     controversial question, we have designed this cross-sectional study in order to establish~     the relationship between HAE clinical manifestations and neurobiological/psychopatological~     parameters.~   "
68599|NCT02159417|"~     A lot of data show that therapeutic education is beneficial for diabetic patients. In the~     French jails, there are very few programs of therapeutic education while this population is~     usually precarious with no access at care sector before the jail.~      The purpose of this study is to determinate if the therapeutic education of the diabetic~     patients is possible in the Paris jail La Santé.~   "
68600|NCT02159404|"~     Nasal mucus as first line defense barrier of the nasal mucosa contains a variety of proteins~     that act as functional units. We recently showed that the nasal mucus proteome between~     allergic rhinitis patients and healthy controls is significantly altered. On protein level,~     immune response in allergic rhinitis is enhanced and barrier function is reduced as~     reflected by increased epithelial permeability. Moreover, there is an unfavorable imbalance~     in innate anti-proteases. Proteases in pollen grain could therefore not be adequately~     deactivated in the mucus further damaging the epithelium which leads to submucosal~     penetration of allergens and facilitated presentation to antigen presenting cells.~      The aim of the present project is to show changes in nasal mucus proteome between allergic~     rhinitis patients and healthy controls over the pollen and non pollen season and to further~     determine whether and if so how the proteome changes under immunotherapy. For the first aim~     patients and healthy controls will be enrolled at two time points namely during the pollen~     season and out of the pollen season. Statistical differences will be determined within the~     groups and between the groups. The protein changes over the time course reflect how~     allergics but also healthy controls react to allergen challenge. The results should give~     insight on possible biomarkers that could be used for diagnostics and therapy. Protein~     substitution or inhibition may be a future therapy to reinforce the barrier function of~     nasal mucus and treat allergic rhinitis symptoms. The effect of immunotherapy as sole causal~     therapy will be determined and therapy responders will be compared to non-responders. We~     hypothesize that responders will show proteome changes similar to healthy conditions. This~     further concretizes distinct proteins as biomarkers that could be used as therapeutic~     agents. Moreover proteome changes could be used to predict and monitor therapeutic success~     or failure and patients may be stratified to be subjected to other therapeutic strategies~     than immunotherapy saving time and money.~      Mucus will be collected with a special suction device equipped with a mucus trap. Then,~     proteomic analysis will be performed by LC MS/MS mass spectrometry. Database search will~     identify distinct proteins and their function, origin etc. will be annotated. Protein groups~     will be analyzed through pathway enrichment and cluster analysis. By this means complex~     proteomic data can be visualized for a better understanding of global changes in protein~     networks and functions.~      Investigating the nasal mucus proteome in diseased and healthy state leads to a better~     understanding of its barrier function and reaction to allergens. Distinct proteins and/or~     proteins groups could be used as biomarkers for novel diagnostic and therapeutic approaches.~     Furthermore, mechanisms of immunotherapy in responders and success or failure of therapy~     could be determined.~   "
68664|NCT02158572|"~     Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.~   "
68602|NCT02159378|"~     The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much~     higher in specific populations.~      The specific treatment of gestational diabetes (diet, control weight gain, self monitoring~     glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and~     preeclampsia compared with abstention therapy, without additional risk of caesarean section.~      Several early studies have shown that the determination of fructosamine is a very bad way of~     diagnosis for Gestational Diabetes. However, few studies have investigated the relationship~     between the determination of serum fructosamine and put under insulin in case of Gestational~     Diabetes.~      The purpose of this study is to determine if serum fructosamines rate can be a predictive~     marker of the starting insulin at the patients suffering from Gestational Diabetes~   "
68603|NCT02159365|"~     To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible~     and safe.~   "
68604|NCT02159352|"~     The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or~     lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.~   "
68605|NCT02159339|"~     Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In~     previous multi-center study, we have found that the prevalence of GDNF family receptor alpha~     1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and~     coordinately associated with GC metastasis and the patients' overall survival throughout~     discovery and testing cohorts in China, Japan and Korea. The present cohort study is to~     investigate whether methylation of those genes can predict the metastasis and prognosis of~     GC.~   "
68606|NCT02159326|"~     Physicians might be concerned that Adempas may have a metabolic interaction with oral~     contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The~     information regarding lack of potential pharmacokinetic interaction has been communicated;~     there is a need for more re-assurance and further data that there is no interaction between~     Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in~     the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is~     considered adequate to inform about safe use of Adempas with OCs.~   "
68607|NCT02159313|"~     To investigate relative bioavailability of crushed tablets suspended in apple sauce or water~   "
68608|NCT02159300|"~     The long-term purpose of the investigator's research is to understand the pathophysiological~     basis of chronic pain. This will help provide a framework for the development of effective~     treatments. The purpose of this specific study is to find if there are abnormal brain~     rhythms in patients with fibromyalgia syndrome (FM) who are in pain since this will indicate~     particular types of treatments.~      FM is a disorder of the muscles and/or joints, and patients experience sever fatigue. FM~     occurs more often in women than in men (3.4% of women, 0.5% of men). The diseases can appear~     at any age, but in most of the cases it occurs in women of childbearing age. FM is~     considered a chronic pain condition since the pain is persistent. Pain and tenderness can be~     widespread throughout the body. FM patients are more sensitive to sound and pressure~     stimulation than healthy controls, indicating that there may be changes in the brain. Also,~     pain is made worse under conditions of stress.~      Treatments for FM pain include life style changes such as exercise, dietary changes,~     cognitive-behavioral therapy, medications and even surgery, but there is no accepted best~     treatment. This is partly because the underlying cause of the pain is not well understood.~     The design of this study is to record brain activity to find if there are abnormal brain~     rhythms in people with FM that are not present in healthy adults of the same age.~      Specifically, the investigators will test the hypothesis that constant low frequency~     oscillations will be present in patients with chronic pain due to FM. This has been found in~     people with other types of pain and is called Thalamocortical Dysrhythmia (TCD). The study~     has two parts. In the first part, a complete medical history will be obtained, including a~     description of the person's pain. In the second part the investigators will use~     magnetoencephalography (MEG) to non-invasively record brain activity. The MEG data will be~     analyzed in terms the presence of normal alpha rhythm and abnormal low and high frequency~     oscillations. Each person will have an MRI so the investigators can localize the rhythms~     recorded by the MEG in the person's brain using their MRI. The people who record and analyze~     the MEG recordings will not know if the person is a healthy control or a FM patient. The two~     parts will be joined to test the hypothesis and find if there is a correlation between the~     people with abnormal low frequency brain rhythms and the presence or degree of pain.~   "
68609|NCT02159287|"~     Patients with Atrial fibrillation (AF) make a unique group of ischemic stroke, mostly caused~     by emboli from the left atrial appendage. Oral anticoagulation (Warfarin) is recommended for~     prevention of recurrent embolic stroke but it takes several days to reach a therapeutic~     international normalized ratio (INR : 2.5) so bridging therapy with a short acting~     intravenous anticoagulant is recommended until therapeutic INR level is reached. A common~     strategy is to use intravenous unfractionated heparin (UFH) until a standard activated~     partial thromboplastin time (aPTT) is reached and then initiating warfarin. Another strategy~     is to use subcutaneous (SQ) injection of a low-molecular-weight heparin (LMWH) eg.~     Enoxaparin.~      The investigators will compare LMWH and UFH, focusing on risk of new stroke and mortality~     rate.~      METHOD: This study is randomized controlled trial that will be performed in 80 patients ages~     between 18 and 75 with confirmed acute ischemic stroke purely due to AF who will be~     hospitalized in Shiraz Medical University affiliated teaching hospitals. Patients will be~     randomly assigned in two groups. A brain CT will be done to confirm the absence of~     intracranial hemorrhage and to assess the size of cerebral ischemia.~      First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body~     weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued~     until the target INR level (2.5) is reached then clexane will be discontinued.~      The second group will receive continuous UFH infusion 1000 unit per hour and then the dose~     will be adjusted to maintain a therapeutic aPTT (two times to baseline) level then warfarin~     will be started (5 mg everyday).~      The investigators will follow patients in both groups until target INR will be achieved~     (2.5) and after that clexane and UFH will be discontinued. Adverse events will be assessed~     in both groups for three months.~      Data will be analyzed with Statistical Package for the Social Sciences (SPSS) version 15 and~     Chi-square statistics.~      Main outcome of our study will be evaluation of new stroke, mortality, central nervous~     system (CNS) hemorrhage, major bleeding, drop out and other unwanted side effects in first~     week and three months after stroke.~   "
68610|NCT02159274|"~     Breast cancer affects a large proportion of Danish women and late morbidity following breast~     cancer treatment including pain, reduced motility and force of the arm and shoulder,~     disturbed sensitivity, and lymph edema affects many patients. The risk for such late~     complications have previously been carefully described by us and others in patients operated~     by traditional methods, but the follow-up in most of these studies have been rather short ,~     and long time follow-up results are not available. The impact of the new oncoplastic~     techniques that allows more women to have breast conserving surgery is not known yet. These~     operations are more extensive and therefore might be accompanied by more complications. The~     purpose of this study is to give answer to that question.The study includes three parts.~     First a questionnaire to patients who have breast conserving surgery performed in one of the~     three breast units in Central Region Denmark. It contains questions regarding arm morbidity,~     quality of life, comorbidity, and body image. The questionnaire should be filled in~     preoperatively and 18 months after surgery. The second part consists of an objective~     evaluation of shoulder and arm function and cosmesis before and after breast conserving~     surgery with and without oncoplastic techniques. This should be performed at baseline before~     surgery and 18 months later. The third part is a long time follow-up of patients after~     breast conserving surgery without oncoplastic techniques. This group of patients is~     recruited from three breast units in Central Region Denmark. It contains questions regarding~     arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be~     filled in preoperatively and 18 months after surgery. The second part consists of an~     objective evaluation of shoulder and arm function and cosmesis before and after breast~     conserving surgery with and without oncoplastic techniques. This should be performed at~     baseline before surgery and 18 months later. The third part is a long time follow-up of~     patients after breast conserving surgery without oncoplastic techniques. This group of~     patients is recruited from the cohort in a previous study with 18 months follow-up following~     breast conserving surgery without oncoplastic technique.~   "
68611|NCT02159261|"~     Local prospective multicenter non-comparative non-interventional observational study. It's~     planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment~     for 13 cycles in real practice.~   "
68665|NCT02158559|"~     This study focused on the effect of Danhong injection on microcirculation in the treatment~     of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.~   "
68666|NCT02158546|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
68612|NCT02159248|"~     The purposes of this study are to:~        -  Evaluate the safety and toxicity of tolfenamic acid when used with gemcitabine and~          radiation therapy in patients with locally advanced or metastatic pancreatic cancer.~        -  Determine the maximum-tolerated dose (MTD) of tolfenamic acid when used with~          gemcitabine and radiation in pancreatic cancer.~        -  Characterize the pharmacokinetic profile of tolfenamic acid when used with gemcitabine~          and radiation.~        -  Assess the anti-tumor response to tolfenamic acid when used with gemcitabine and~          radiation in patients with advanced pancreatic malignancies.~   "
68613|NCT02159235|"~     The present study aims is to investigate:~        1. whether patients suffering from acute resp. chronic ischemic heart disease show higher~          levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international~          reference levels suggest;~        2. the correlation between severity of coronary artery disease and angiogenic and~          angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth~          factor, osteopontin-OPN) The patient population consists of about 270 female and male~          patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21;~          CIHD: ICD-10 I25).~        3. whether patients suffering CAD and valve calcification (mitral annulus, aortic valve)~          show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to~          patients with CAD but without valve (annulus) calcification The measurement of cadmium~          (urine), lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin~          (plasma) in patients with angiographically verified coronary artery disease are in the~          fore. Furthermore, basic laboratory diagnostics as well as data from coronary~          angiography and echocardiography will be collected. Additionally, the investigators~          will inquire heavy metal exposition during life by an interview.~      Recruitment will be done during the in-patient stay at the General Hospital of Vienna,~     Medical University of Vienna.~   "
68614|NCT02159222|"~     The purpose of this study is to determine whether an additional physical therapy program can~     improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an~     illness in which the body has a severe response to bacteria or other germs and develops~     worsened function of a major organ such as the kidneys, heart, or lungs).~   "
68615|NCT02159209|"~     Some medications are known to cause kidney damage because the person is allergic to the~     medication while others cause direct damage to the kidney because they are toxic at certain~     concentrations. Risk factors for developing kidney damage have been identified for some~     medications but not for all. Patients who are exposed to these important medications and~     develop problems with their kidneys may have some genetic risk. The purpose of this study is~     to determine the genetic risk factors for drug induced kidney injury. A better understanding~     of the role of genetics for the development of kidney injury from medications will allow us~     to better select medications, improve effectiveness of treatment and minimize harm.~   "
68616|NCT02159196|"~     The purpose of this multi-center randomized controlled non-inferiority trial is to determine~     the effect of a strategy using routine nebulisation of mucolytics and bronchodilators (four~     times daily) as compared to a strategy using nebulisation of mucolytics or bronchodilators~     only on clinical indication (i.e. occurrence of persistent thick and tenacious sputum or~     bronchospasm) in mechanically ventilated intensive care patients. The investigators will~     examine the effects in terms of ventilator-free days, defined as the number of days alive~     and free of ventilation at day 28 after start of ventilation.~      We hypothesize that a strategy that uses nebulisation of mucolytics or bronchodilators only~     on clinical indication not to be inferior to a strategy using preventive nebulisation of~     mucolytics or bronchodilators with regard to the number of ventilator free days in ICU~     patients at day 28.~   "
68617|NCT02159183|"~     This study will investigate the effect on the soft tissue that is in contact with a dental~     implant with a modified surface of the neck (the part of the implant that is above the bone~     and in contact with the soft gum tissue).~   "
68618|NCT02159170|"~     Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia~     for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological~     ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of~     pain and hyperalgesia are not yet understood in this group of patients. The investigators~     plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy~     subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using~     functional magnetic resonance imaging and resting state network analysis.~   "
68619|NCT02159157|"~     This study is designed to randomly assign breast cancer patients requiring and agreeing to~     chemotherapy into two groups. One group will be receive an exercise prescription aimed at~     increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per~     week. The other group will not receive a exercise prescription but their activity will be~     recorded. The hypothesis is that participants that are most active will exhibit improved~     chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers~     for inflammation in their blood.~   "
68620|NCT02159144|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Recent studies also~     reveal the presence of a subset of cells in WAT that could be induced by environmental or~     hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been~     suggested to have strong antiobesity and antidiabetic benefits. More recently, same studies~     showed that cold stress stimulate the browning of subcutaneous white adipose. However, to~     the investigators knowledge, there are no direct data that clearly show that cold stress can~     promote the browning of subcutaneous white adipose.~   "
68639|NCT02158897|"~     Evidence from bio-gerontology research from our laboratory and others have showed that~     short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting~     normal cells and tissues and potentially sensitizing malignant cells to chemo drugs.~     Furthermore, STS improves risk factors associated with aging and age-related disease in~     rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible~     or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted~     in a pilot human trial. The objective of the study is to ascertain the impact of the~     fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months.~     The investigators hypothesize that the specially designed dietary regimen can reduce the~     risk factors for metabolic syndrome and biomarkers associated with aging and age-related~     diseases.~   "
68621|NCT02159131|"~     This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744~     (744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a~     commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and~     levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in~     Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive~     oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC~     free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC~     alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined~     on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel and~     ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration with~     744 results in a significant change in OC exposure compared to OC alone. Subjects will~     return to the study center for final follow-up evaluations 7 to 14 days after the last dose~     of study medication (Days 28 to 35).~   "
68622|NCT02159118|"~     The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy~     device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to~     obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered~     device will improve the quantity and quality of bone marrow biopsy specimens when compared~     to the manual device.~   "
68623|NCT02159105|"~     This study is designed to see if abdominal ultrasound after planned cesarean delivery can~     identify women with ongoing intra-abdominal bleeding.~   "
68624|NCT02159092|"~     Tobacco use kills more than 500,000 people in the United States each year. Although the use~     of cigarettes has declined, the use of other tobacco products has remained steady. Waterpipe~     smoking is a common form of tobacco smoking after cigarettes in the U.S. In fact, in 2007~     the American Lung Association issued a policy alert to warn consumers about this first new~     tobacco trend of the 21st century (American Lung Association, 2007). Few studies have been~     conducted on waterpipe smoking to investigate its harmful effects. Furthermore, no known~     studies have evaluated treatments for smoking cessation in waterpipe smokers. This study~     aims to test the role of contingency management (CM) in promoting abstinence from waterpipe~     smoking for 5 weeks verified by salivary cotinine and to characterize self-reported nicotine~     withdrawal symptoms. Based on the alarming growth rate over a short period of time in~     waterpipe tobacco smoking, there is a critical need for clinical research to investigate~     treatment modalities targeting smoking cessation for waterpipe smokers. Given the evidence~     for the role of CM in promoting abstinence from many types of drug use, investigation of the~     utility of CM for waterpipe smoking cessation is important and timely. Although Nicotine~     Replacement Therapy is the mainstay treatment for treating nicotine dependence delivered~     through cigarettes, the intermittent use patterns that characterize waterpipe smoking~     suggest that CM may be more effective in promoting waterpipe smoking cessation. The evidence~     based knowledge generated in this study may assist in the translation of the treatment~     program into public health practice.~   "
68625|NCT02159079|"~     Sepsis is a common inflammatory response to infection characterized by hypovolemia and~     vasodilation for which early administration of intravenous fluids has been suggested to~     improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic~     patients treated in the intensive care unit commonly receive significant volumes of~     intravenous fluids with resultant positive fluid balance for up to a week after their~     initial resuscitation. Observational studies have associated fluid receipt and positive~     fluid balance in patients with severe sepsis and septic shock with increased mortality but~     are inherently limited by indication bias. In order to determine the optimal approach to~     fluid management following resuscitation in patients with severe sepsis and septic shock, a~     randomized controlled trial is needed. The primary hypothesis of this study is that,~     compared to usual care, a conservative approach to fluid management after resuscitation in~     patients with sepsis and cardiopulmonary dysfunction will increase intensive care unit free~     days.~   "
68626|NCT02159066|"~     The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in~     combination with targeted agents after progression on LGX818/MEK162 combination therapy, as~     well as the safety and tolerability of the novel triple combinations.~   "
68627|NCT02159053|"~     The purpose of this study is to provide 16-week efficacy, safety and tolerability data~     versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)~     self-administration with or without a loading regimen and maintenance dosing using~     pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in~     subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic~     anti-TNFα therapy.~   "
68628|NCT02159040|"~     The primary objective of the study is to compare the overall response rate (inclusive of~     complete response, partial response and hematologic improvement) per IWG 2006 criteria in~     patients with higher risk MDS treated with azacitidine with or without deferasirox achieved~     over the course of one year. Hematologic improvement must be maintained for at least 8~     weeks.~   "
68629|NCT02159027|"~     Maraviroc is an antiretroviral medication that may help in improving mental function in HIV~     infected patients with mental problems by decreasing inflammatory tendencies. We will test~     this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental~     problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar~     pill to their HIV medications and see if mental function improves over 48 weeks. This study~     will be conducted at 2 sites in Hawaii and Puerto Rico.~   "
68640|NCT02158884|"~     The goal of the PRIORITI-MTF study is to help determine whether a new type of custom~     designed brace, called the IDEO ™ along with a physical therapy program, called Return to~     Run, improves physical function. This brace was developed for wounded warriors who wanted to~     return to an active lifestyle.~      The primary objective of this study is to examine the benefits (and cost-benefits) of an~     integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic~     Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but~     designed for scalability in the broader military environment (i.e. beyond San Antonio~     Military Medical Center where the program was developed)~   "
68667|NCT02158533|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
70178|NCT02138773|"~     The purpose of this study is to investigate the relative bioavailability of two types of~     prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The~     safety of tamsulosin formulation is also compared.~   "
68630|NCT02159014|"~     Regular physical activity improves physical and mental health and reduces the risk of heart~     disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately~     the majority of adults are not active enough to reap these benefits. People who are inactive~     and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from~     increased activity can be identified in primary care by combining standard risk tools. These~     high risk patients can be offered physical activity programmes that are designed to increase~     longterm adherence. Aerobic dance is an activity that combines physical, social and~     cognitive stimulation and allows easily adjusted intensity levels to meet individual needs.~     Engagement in an activity program also provides opportunities to offer advice on healthy~     nutrition and associated meal preparation skills. Information technology can be used to~     increase activity participation. Video materials can be produced to guide activity~     participation at home, thereby increasing overall activity participation. The investigators~     propose a feasibility study of a multimodal dance-based physical activity and nutrition~     intervention aimed at patients at high risk of stroke, heart disease, diabetes and dementia,~     in primary care settings.~   "
68631|NCT02159001|"~     Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used~     in psychiatry. Only case reports and open label non-randomized studies have been published~     of ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study~     the efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia~     patients taking clozapine.~   "
68632|NCT02158988|"~     Patients with histological proven gastric cancer (including cancer of the esophagogastric~     junction (AEG)) and synchronous peritoneal carcinomatosis, who fulfill the inclusion and~     exclusion criteria, can be recruited in this study. There are two treatment groups (A and~     B). The chemotherapy applied intravenously is the same in both groups and is approved for~     the treatment of gastric cancer. Patients with negative or unknown HER-2 status will be~     administered Epirubicin, Oxaliplatin and Capecitabine (EOX). Patients with positive HER-2~     status will be treated with Cisplatin, Capecitabine and Trastuzumab (CCT).~      The chemotherapy is followed by surgical cytoreduction in both groups. Patients randomized~     into group B will be treated with an intraperitoneal (in the abdominal cavity)~     chemoperfusion with Mitomycin C and Cisplatin .~      Patients in both groups receive 3 cycles of postoperative chemotherapy within 4-12 weeks~     after the surgical procedure and are followed up for 30 months.~      If progress of the tumor is detected the patient will no longer be treated according to the~     study therapy. Patients of group B may get a HIPEC intervention without surgical~     cytoreduction if contraindication to the drugs applied can be excluded.~   "
68633|NCT02158975|"~     Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately~     30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be~     active in this disease and will improve best objective response.~      We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting~     T-cell-specific transcription factor) expression, which is associated with poor prognosis,~     and whether GATA-3 expression represents a novel predictive biomarker for MLN9708~     sensitivity.~   "
68634|NCT02158962|"~     The purpose of this study is to combine a culturally tailored and integrated Risk Reduction~     Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused~     women to a 1) Healthy Relationships experimental group of three sessions of risk reduction~     interventions or 2) a Healthy Living comparison control group of three session of health~     promotion activities to determine if the combined, intervention is safe and effective in a~     test the following hypotheses:~        1. Women in the integrated risk reduction intervention will score significantly lower on~          outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of~          Session III and at 3 and 6 months than women in the control group~        2. Women in the integrated risk reduction Intervention will score significantly higher on~          IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3~          and 6 months than women in the control group.~      Several exploratory and major controlled studies on the mainland US have shown intimate~     partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of~     physical, reproductive and mental health problems, including sexually transmitted infections~     and HIV/AIDS, many of which are areas of known health disparity for African American and~     Latina women. A recently completed study of African Caribbean and African American women in~     the US Virgin Islands revealed that nearly one third of women reported lifetime partner~     abuse and increased risk for sexually transmitted infections including HIV/AIDS. Abused~     women in the USVI had significantly more risk factors for HIV/AIDS than did women who were~     not abused.~      The proposed intervention combines an empowerment model designed to help abused women make~     choices that protect the physical and emotional health of the woman and her family with a~     sexual safety model designed to help her make choices to reduce her risk of acquiring an STI~     or contracting HIV/AIDS. The integrated model adapts two interventions that have been tested~     with African American women on the US mainland and found to be effective as separate~     interventions for IPV and IPA and reducing the risk of STI/HIV. The adapted interventions~     will be used with abused African Caribbean women based on an a priori assessment of the~     cultural attitudes, beliefs and resources available to women living in an island environment~     with limited resources.~   "
68635|NCT02158949|"~     In this study, the investigators will be developing and testing a mobile phone text message~     intervention to reduce alcohol use for people at risk of alcohol dependence. The~     investigators hypothesize that this intervention will be acceptable to participants, and~     that they will stay in the intervention until it's one week completion.~   "
68636|NCT02158936|"~     Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin~     receptor agonist that may be beneficial in medical disorders associated with~     thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with~     thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver~     disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350~     subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the~     placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with~     intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75~     Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind,~     parallel group, placebo-controlled study designed to explore the platelet supportive care~     effects of eltrombopag versus placebo in combination with the standard of care~     hypomethylating agent, azacitidine. The primary objective of this study is to determine the~     effect of eltrombopag versus placebo on the proportion of subjects who are platelet~     transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints~     include overall survival, disease response, and disease progression.~   "
68637|NCT02158923|"~     The purpose of this study is to determine whether individualized ventilatory management~     combining the use of low tidal volumes, alveolar recruitment maneuvers, individually~     titrated positive end-expiratory pressure and postoperative individualized ventilatory~     support will decrease postoperative complications, unplanned ICU readmissions, ICU and~     hospital length of stay and mortality compared to a standardized Lung Protective Ventilation~     (LPV) for all patients at risk.~   "
68638|NCT02158910|"~     The purpose of the study is for investigation and collection of Aricept safety information~     with a dose increase on Alzheimer's disease patients.~   "
68641|NCT02158871|"~     The purpose of this study is to compare the impact of a new workplace-based mental health~     peer education program with standardized mental health literacy training on early~     intervention and support for healthcare employees with mental health issues. Participants~     are healthcare workers who volunteer to participate in one of the two twelve-hour group~     education programs. It is hypothesized that the customized Beyond Silence peer education~     program led by trained staff members with personal experience of mental ill-health will be~     more effective in reducing the stigma associated with help-seeking and help-outreach~     regarding mental ill-health in the workplace. The comparison group is a standardized mental~     health literacy training program that has been widely implemented in both Canada and around~     the world. Change in help-seeking/help-outreach behavior, mental health knowledge and~     beliefs of participants will be assessed at three-month intervals; before, after and three~     months following the educational intervention.~   "
68642|NCT02158858|"~     Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with~     previously treated Acute Leukemia, Myelodysplastic Syndrome,~     Myelodysplastic/Myeloproliferative Neoplasms, and Myelofribrosis. CPI-0610 is a small~     molecule inhibitor of bromodomain and extra-terminal (BET) proteins.~   "
68643|NCT02158845|"~     The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic~     inflammatory disease affecting 10% of women. The objective of this study is to compare the~     hemostatic effects of two treatments widely prescribed to women with endometriosis: the~     levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog~     (GnRHa) leuprolide acetate.~      Hypothesis:~      H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There~     is alteration in hemostatic system with the use of GnRHa or LNG-IUS~   "
68644|NCT02158832|"~     This study is being conducted to determine if electro-acupuncture can reduce swelling of the~     arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research~     conducted on animals suggests that such treatment might be used to improve circulation~     leading to reductions in swelling. Previous research in humans with lymphedema suggests that~     treatment may be safe to use, although results regarding its efficacy in the reduction of~     swelling have not yet been established.~      This research will use sophisticated, non-invasive assessment methods to determine if a~     single session of electro-acupuncture treatment can be effective for reducing lymphedema.~     Results may be used to further develop our understanding of how electro-acupuncture can be~     used in the management of this condition. Electro-acupuncture may provide a promising~     complement or alternative to conventional lymphedema treatments such as compression~     bandaging, massage therapy or surgery.~   "
68645|NCT02158819|"~     The purpose and primary objective of this study is to compare health economic outcomes~     between the use of a patient-matched cutting guide (Visionaire) versus the use of standard~     instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively,~     intra-operatively and post operatively up until and including the six week post-operative~     assessment. The secondary objectives of the study are to compare safety and early~     readmission rates between the two techniques. The study hypothesis is that there is no~     difference in the cost of the episode of care from hospital admission to discharge,~     including pre-operative radiology costs and cost of resources, with the Visonaire~     patient-matched cutting guide compared to standard instrumentation.~   "
68646|NCT02158806|"~     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,~     lifestyles and activity, especially in older patients. There are few effective treatments -~     compression therapy (tight bandaging or stockings) helps healing, but about half the people~     with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking~     aspirin as well as using compression may speed up healing for VLU, but the current evidence~     is not enough to change clinical practice. We will conduct a randomised controlled trial to~     test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.~   "
68647|NCT02158793|"~     The purpose of this study is to perform face transplants on people who have suffered severe~     facial trauma with tissue and functional loss; and evaluate the acceptance and function of~     the transplanted tissue. The aim of the transplant is to provide patient a more normal~     appearance . Additionally we aim to restore functioning, movement, and sensation of their~     face including that of the lips, mouth, and eyes.~   "
68648|NCT02158780|"~     Undescended Testis is the most common congenital abnormality of the genitalia in boys and it~     is commonly managed by surgical intervention. Evidence in the medical literature to support~     the superiority of either scrotal or inguinal (standard) orchidopexy is lacking. To~     determine which technique is superior, this study focuses on the degree of post-operative~     pain after surgery. Therefore, the objective of this randomized control trial is to~     determine if scrotal orchidopexy reduces postoperative pain in children diagnosed with~     undescended testis when compared to standard inguinal orchidopexy.~   "
68649|NCT02158767|"~     This clinical trial studies the use of a second infusion of donor hematopoietic cells that~     have had removal of T cells for the treatment of engraftment failure after a first~     hematopoietic stem cell transplant.~      Hematopoietic cell transplants from donors can be complicated by complete or incomplete~     failure of recovery of blood counts. This results in frequent needs for transfusions and~     other methods to maintain blood counts at acceptable levels. One way of improving the blood~     counts in the recipient is to give a booster dose of cells from the donor, but this is~     associated with increased risk of an immune reaction from the donor cells against the~     recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,~     responsible for this type of immune reaction. These cells are removed by a special handling~     of the graft, which allows to remove the cells directly or indirectly (by selecting other~     cells to stay in the graft).~   "
68650|NCT02158754|"~     This retrospective study will investigate clinician behavior in diagnosing patients with~     possible obstructive coronary artery disease who received a CORUS® CAD result compared to~     patients who did not have the test performed (matched control patients). The data collected~     will be from primary care practices and will also assess one to two year health outcomes~     (MACE, procedure complications). Furthermore, in these real world practice settings, the~     study will investigate the economic impact of CORUS® CAD usage at each practice using~     practice specific data, when available.~   "
68702|NCT02158078|"~     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported~     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2~     diabetes mellitus (T2DM).~   "
68653|NCT02158715|"~     For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most~     important teaching point. However, the tool to feedback depth of chest compression like~     Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to~     be used widely. In these days, smartphone free application can measure depth of chest~     compression in real-time. This study assess the validity of depth of chest compression by~     smartphone application, PocketCPR, as three sites of smartphone on arm or hand.~      1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band~      To analyze the difference between Skill Reporter manikin and PocketCPR application, the~     investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.~   "
68654|NCT02158702|"~     Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide~     will treatment on pomalidomde and dexamethasone.~      Baseline, follow-up, survival and toxicity information will be collected.~   "
68655|NCT02158689|"~     The accurate identification and efficient management of poor responders remains one of the~     most enigmatic challenges in assisted reproductive technology (ART). The investigators study~     will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who~     poor responders.~   "
68656|NCT02158676|"~     The study will recruit patients submitted to bariatric surgery. Individuals will be~     supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days.~     Immunological, metabolic and anthropometric parameters will be assessed before and after the~     supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate~     plasma concentrations of immunological and metabolic parameters and anthropometric measures~     of subjects undergoing gastric bypass Roux-Y.~   "
68657|NCT02158663|"~     Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1~     Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater~     improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS~     score. The secondary objectives include: one, testing which treatment provides a~     significantly greater improvement in depressive symptoms as measured by change in QIDS~     score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for~     PTSD symptoms; and three, testing which treatment is better tolerated as measured by~     participant drop out and side effect profiles.~      Research Design: Randomized single-blind (raters) prospective clinical trial testing the~     effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.~      Methodology: Veterans 18 to 50 years of age suffering from PTSD with and without depressive~     symptoms will be recruited from the community as well as from the mental health clinics at~     the James A. Haley Veterans Administration Hospital. Plan to enroll 50 in order to have an~     evaluable sample of approximately 20 in each group. Participants will be consented and~     undergo screening for safety and appropriateness to be in the trial. Those deemed eligible~     will be evaluated with clinical measures of function, PTSD, depression, pain, and~     neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by~     significant depression defined as MADRS greater than 19) to one of two active treatments:~     right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo~     assessment for safety prior to each treatment. The treatments will be performed 5 days a~     week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1~     day per week. Clinical evaluations will be performed at baseline, after every five~     treatments, at the end of the treatment, and at 1 and 3 months post treatment. CAPS and IPF~     scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz~     right prefrontal rTMS for PTSD symptoms and function respectively. The QIDS scores will be~     used to test for a significant difference in change in depressive symptoms for both the~     participants with significant depressive symptoms and the entire group. The number of~     dropouts (related specifically to side effects and all cause) will be used along with side~     effect profiles to test for differences in tolerability of the two treatments.~   "
68658|NCT02158650|"~     The purpose of this study is to determine if presenting treatment options to basal cell~     carcinoma patients in video format will improve efficiency and allow patients to receive~     consistent, comprehensive, visually-depicted treatment option information to improve patient~     quality of care. Patients can learn more about treatment options as they are depicted~     visually so as to better assist them in understanding treatment risks and benefits to~     confidently make a well-informed decision. Primarily, the study will evaluate efficiency~     when using the education video medium. The study will also evaluate the effectiveness of the~     video medium as an aid to decision making in addition to standard of care in comparison to~     the standard of care alone. Additionally, the study will evaluate both patients' and~     dermatologists' satisfaction of the educational intervention.~   "
68659|NCT02158637|"~     This study is being done to try out questions from a large set of questions called the~     Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events~     (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms.~     This study will look at properties of these questions and will provide information about how~     these questions can be improved for research studies. PRO-CTCAE questions were developed~     under a contract from the National Cancer Institute (NCI) to allow patients to self-report~     symptoms in future cancer clinical trials. Patients with cancer receiving treatment will~     complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet~     containing a commonly used questionnaire for assessing quality of life, functioning, and~     symptoms at two visits one to six weeks apart. Some patients will additionally complete~     web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while~     completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone~     system. Lastly, a small number of patients will complete only a single visit in which a~     web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is~     completed in addition to a paper booklet containing a commonly used questionnaire for~     assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores~     for PRO-CTCAE questions will differ between patients with high versus low general well-being~     as measured by your doctor using a scale called the Eastern Cooperative Oncology Group~     Performance Score.~   "
68660|NCT02158624|"~     To establish the correlation between visual acuity improvement and QOL measurement after~     ranibizumab treatment for AMD patients.~   "
68661|NCT02158611|"~     This project aims to provide more treatment options to suicide patients to further enhance~     the holistic medical services in Far Eastern Memorial Hospital. It focuses on high-risk~     cases, especially those whose suicidal behaviors are triggered by interpersonal/or emotional~     problems because psychological counseling or interpersonal growth groups of services have~     been shown to be beneficial to this population.~   "
68662|NCT02158598|"~     This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women~     aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D~     concentration following vitamin D supplementation with chewable tablets versus pills.~     Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet~     supplement. Questionnaires on physical activity, sunlight exposure and dairy product~     consumption will be administered to adjust for confounding factors. A questionnaire will be~     administered to assess satisfaction and pill count to evaluate adherence to treatment. This~     research intends to test the hypothesis that the vitamin D chewable tablet supplement is as~     effective as a traditional vitamin D pill supplement to increase serum 25(OH)D~     concentrations.~   "
68668|NCT02158520|"~     This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle~     formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients~     with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such~     as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Bevacizumab may stop the growth of tumor cells by binding~     to a protein called vascular endothelial growth factor (VEGF) and by preventing the growth~     of new blood vessels that tumors need to grow. Ipilimumab blocks a substance called~     cytotoxic T-lymphocyte-associated antigen-4 (CTLA4) on the surface of T cells and may help~     the immune system kill cancer cells. It is not yet known whether paclitaxel~     albumin-stabilized nanoparticle formulation and bevacizumab is more effective than~     ipilimumab in treating melanoma.~   "
68669|NCT02158507|"~     This study will evaluate the effectiveness and safety of the combination of two drugs,~     Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer~     that have undergone previous treatment. Veliparib is an investigational drug and has not~     been approved by the FDA while Lapatinib has been approved by the FDA for another type of~     breast cancer. All eligible participants will receive the study medications and not a~     placebo.~   "
68670|NCT02158494|"~     The investigators hypothesis is that electrical stimulation to the tongue that directly~     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural~     impulses to the brainstem and cerebellum. The investigators call this cranial nerve~     non-invasive neuromodulation (CN-NINM). The activation of these structures induces~     neuroplasticity when combined with specific physical, cognitive and/or mental exercises,~     promoting recovery of selected functional damage such as problems with balance or walking.~      44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training~     followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of~     the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will~     use very low level stimulation in conjunction with the exercise, and will serve as a control~     group.~   "
68671|NCT02158481|"~     The main aim of the study is to investigate the effects of dietary ingredients (polyphenols~     and carotenoids) on vascular function during acute glucose load. Each subject will receive 4~     weeks of intervention with test product or placebo product after a dietary restriction~     run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test~     (OGTT) immediately after the run-in phase and at the end of the intervention phase. During~     the OGTT, blood samples will be taken at regular intervals.~      The study will be conducted in subjects with impaired glucose tolerance.~   "
68672|NCT02158468|"~     The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study~     that will assess the effect of different intrahospital conditioning protocols on myocardial~     damage assessed by MRI in patients with acute ST-elevation myocardial infarction.~      The following groups will be compared:~        1. Combined intrahospital pre- plus postconditioning versus~        2. Postconditioning versus~        3. Control~   "
68673|NCT02158455|"~     The investigators have developed a novel technique for saphenous vein graft harvesting for~     coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of~     surrounding tissue. A randomized trial has shown a significantly higher patency rate for~     vein grafts harvested with this new methode compared to conventional harvesting technique~     8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective~     randomized trial comparing patency between vein grafts harvested with surrounding tissue and~     radial artery grafts. The result showed that vein grafts harvested with surrounding tissue~     had a significantly higher patency rate compared to radial artery grafts 3 years after~     surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients~     included in the second randomized trial. The hypothesis is that vein grafts harvested with~     surrounding tissue have a significantly higher patency rate compared to radial artery grafts~     8 years after surgery.~   "
68674|NCT02158442|"~     The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing~     antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes~     who have a significant lower limb infection and it is deemed that IV antibiotics are needed~     in order to salvage the limb or life.~   "
68675|NCT02158429|"~     1. A randomized trial of 3-dimensional vs. 2-dimensional ultrasound, comparing scores on~          the Maternal Antenatal Attachment Scale (MAAS), a validated instrument measuring~          maternal attachment as a marker of maternal bonding. The hypothesis is that~          3-dimensional ultrasound is better at eliciting maternal attachment than 2-D~        2. To assess changes in maternal confidence to stop using drugs and quit/reduce smoking~          with 3-D vs. 2-D ultrasound. Again, the hypothesis is that 3-D ultrasound will improve~          the woman's confidence to stop using substances.~        3. To evaluate if 3-D ultrasound improves paternal attachment as measured by pre- and~          post- scores on the Paternal Antenatal Attachment Scale (PAAS). The hypothesis is that~          3-D ultrasound will have a greater effect on PAAS scores than 2-D.~   "
68676|NCT02158416|"~     The planned minimal risk study is a blinded study on consecutive transfusable platelet~     products. The aim of the study is to evaluate the quality of platelet components sampled~     prior to transfusion.~      The primary patient transfusion outcome in this study is the 1-hour corrected count~     increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products~     will be sampled for ThromboLUX testing before being sent from the blood bank to the~     treatment center. After receipt at the treatment center, the platelet products will be used~     as per regular clinical practice, and the outcome data from each patient will be collected.~     At the end of the study, TLX Scores will be compared to the transfusion outcomes to~     determine if a low TLX Score is associated with a poor transfusion outcome.~      During the course of the study, the TLX Score will not be known to the clinicians, or~     utilized in any way to decide if the platelet product should be transfused.~   "
68677|NCT02158403|"~     The purpose of this study is to assess how often blood clots form in the FDA-approved~     HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to~     clotting within the pump.~   "
68703|NCT02158065|"~     The purpose of this 3 month randomized intervention study is to investigate the additional~     effect of a physical activity telecoaching program on physical activity in patients with~     COPD, compared with usual care.~   "
68678|NCT02158390|"~     Children with Down syndrome (DS) have greater difficulty acquiring expressive language than~     is predicted by their general cognitive abilities and language comprehension (Miller, 1999).~     To date, interventions to improve communication outcomes for children with DS have met with~     only modest success. The proposed study is a randomized controlled trial of an early~     communication intervention combining two evidence-based treatments that teach expressive~     communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint~     Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC).~     The intervention (a) teaches the foundations of communication (joint attention, play), (b)~     builds on positive child characteristics of social attention, (c) uses naturalistic~     strategies to increase the rate and complexity of communication and increase task~     engagement, (d) addresses the potential value of adding visual support (AAC) to spoken~     communication, and (e) includes parents as implementers of the intervention to promote~     generalization across settings and activities, and to ensure maintenance over time. It is~     hypothesized that children with DS enrolled in the intervention will have better language~     and communication skills at the end of treatment and followup than children in the BAU~     comparison group.The study will enroll 82 30 to 54 month old children with DS who have fewer~     than 20 words. Examining predictors of response to treatment and the effects of treatment on~     executive functioning will inform both theory and practice.~   "
68679|NCT02158377|"~     Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent~     (TSV) dental implants loaded early in maxillary and mandibular sites.~   "
68680|NCT02158364|"~     The purpose of this survey is to assess the safety of freeze-dried live attenuated measles~     and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live~     attenuated measles and rubella combined vaccine Takeda) in terms of the occurrence of~     unknown/known adverse drug reactions and factors that may influence the safety of vaccinees~     after the second vaccination.~   "
68681|NCT02158351|"~     Several experimental data suggest that gut-derived endotoxin and GM composition can act as a~     second hit or insult to convert hepatic SS to NASH and cause both local hepatic and~     systemic inflammation.This study's aim is to analyze microbiota diversity, providing~     information both on intestinal microbial composition and on the metabolic processes linked~     to them. In addition, we will correlate, for the first time, GM composition to hepatic and~     white adipose tissue gene expression patterns of interest and serum and fecal markers~     possibly related to impaired fat storage and inflammation. We aim to provide preliminary~     data to design future intervention studies with pre- or probiotics or bile acid derivatives~     to prevent/treat inflammation and fibrosis in NAFLD patients.~   "
68682|NCT02158338|"~     Six studies have preceded this project. Three studies suggested that there is a significant~     connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg,~     1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma~     benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames,~     Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington,~     Brown & Wolfe, 2011).~      This study proposes to study in a more thorough fashion the question of the incidence of~     bonding disruptions with between mothers and their children with asthma. This time there~     will be a larger sample, and more stringent criteria will used in assigning children to the~     asthma cohort. Through questions answered by mothers whose children have been said to have~     asthma, we will be able to decide if the children's respiratory conditions are likely to be~     attributable to asthma or more likely reflective of another respiratory condition such as~     vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).~   "
68683|NCT02158325|"~     Different capsulorhexis size results in different capsular outcome when treating pediatric~     cataract, and there should be an appropriate capsulorhexis size for the best capsular~     outcome.~   "
68684|NCT02158312|"~     Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor~     circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to~     enhance after-effects of rehabilitation through membrane polarization modulation. In this~     double-blind, crossover randomized controlled trial, we aim to investigate whether~     single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with~     upper extremity rehabilitation therapy modulates ipsilesional motor circuit excitability~     using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.~   "
68685|NCT02158299|"~     After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma~     formation and it can not be ignored.Investigators aimed to study two new methods of~     application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation~     and to verify the efficacy and safety of these two applications.Try to prove them as~     beneficial supplements for axillary lymphadenectomy of breast cancer.~   "
68686|NCT02158286|"~     Retention of the gastric tube after esophagectomy is a clinically important problem, and~     there is a need of a simple method to evaluate emptying rate from the gastric tube after~     esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the~     gastric tube. In non-operated patients, paracetamol clearance technique have been widely~     used for measuring gastric emptying rate. There is no validation however if paracetamol~     clearance technique can be used for measuring emptying rate of the gastric tube. The~     investigators aim of this pilot- study is to validate paracetamol clearance technique to~     scintigraphy for measuring emptying rate from the gastric tube and to evaluate if there is a~     correlation between symptoms of retention and quality of life with the emptying rate.~   "
68687|NCT02158273|"~     The primary hypotheses under test are that alcohol dependent subjects treated with~     fenofibrate will report decreased craving for alcohol following cue-exposure in the~     laboratory and report less drinking post treatment relative to placebo.~   "
68688|NCT02158260|"~     It is a single center, prospective and self-controlled trial. We'd like to explore a new~     method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)~   "
68736|NCT02157636|"~     Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with~     previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain~     and extra-terminal (BET) proteins.~   "
69798|NCT02143778|"~     This study will be used to train an algorithm using Methacetin breath test (MBT) measures~     and to select a cut-off to determine presence or absence of Clinically Significant Portal~     Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg~   "
68689|NCT02158247|"~     1. Airway length from the medial incisor to carina is divided into four segments ; the~          length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to~          vocal cords and vocal cords to carina.~        2. Determining the mean length of each segments with the direct laryngoscope,~          videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.~        3. Making a new formula to determine the proper individualized depth of intubation on the~          basis of the length of segments~        4. Virtual experiment : comparing the new formula with conventional method of determining~          the depth of endotracheal intubation~   "
68690|NCT02158234|"~     This study involves another course of radiation (called re-irradiation) to the participant's~     tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The~     purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT~     given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of~     radiation will work best in controlling the growth of head/neck cancer. The usual treatment~     for head/neck cancer that has grown is surgery and/or more radiation with various~     chemotherapy drugs.~   "
68691|NCT02158221|"~     The investigators hypothesized that migraine without patients with many genetic loci~     associated with migraine (high genetic load) would be more sensitive and get provoked more~     migraine attacks by PACAP compared to patients with few genetic loci associated with~     migraine (low genetic load).~   "
68692|NCT02158208|"~     The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of~     Horton's disease.~      At the inclusion visit, patients will have, as is the case in the usual strategy:~        -  A complete clinical examination carried out by the doctor in charge of the patient~        -  ESR, and CRP and fibrinogen assay~        -  A full blood count for leukocytes and lymphocytes~        -  A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting~          Horton's disease. The clinician in charge of the patient will decide if a second biopsy~          is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological~          cytology service. Immunohistochemical analyses will be done if the TAB is positive.~      In addition to the standard clinical examination and complementary examinations relative to~     the patients' pathology, the following will be done:~        -  Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4)~          and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it~          possible to calculate the absolute value for different T lymphocyte populations.~        -  A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which~          will be stored at -80°C for future assays for cytokines and other biomarkers of~          interest for Horton's disease.~        -  16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used~          immediately for cytometric and functional analyses.~   "
68693|NCT02158195|"~     The aim of this study is to compare different blood cells of the immune response in patients~     with Autoimmune Hemolytic Anemia and healthy subjects.~      Evaluate the impact of treatments, notably corticoids, on blood cells of the immune~     response.~      Better understanding of the mechanisms involved in the course of this disease could lead to~     new treatments.~      12 patients with Autoimmune Hemolytic Anemia will be compared with 12 controls matched for~     sex and age.~      Controls will provide blood samples only once. The will have no particular follow-up.~      Patients will provide blood samples at the time of diagnosis then 3 months after the start~     of treatment. If a new treatment needs to be started before the end of the 3-month period, a~     new blood sample will be taken.~   "
68694|NCT02158182|"~     The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and~     rifaximin are effective in the prevention of the development of hepatic encephalopathy in~     cirrhotic patients with acute variceal bleeding~   "
68695|NCT02158169|"~     The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha~     biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to~     concomitant iron supplementation.~   "
68696|NCT02158156|"~     The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy~     can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10~     weeks.~      Participants will be evaluated on maximal oxygen consumption and maximal workload measured~     by an incremental test at baseline and at the end of the exercise period.~   "
68697|NCT02158143|"~     evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young~     people.~   "
68698|NCT02158130|"~     The proposed study seeks to better understand the role of body weight, energy expenditure,~     and energy intake as mechanisms of body weight gain during detraining following aerobic~     exercise. It is hypothesized that participants in the higher dose exercise group will have~     greater body weight gain compared to the lower exercise dose and control group from wk 24 to~     wk 76 follow-up.~   "
68699|NCT02158117|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. The annual death toll from overdose is about 250, twice the annual death toll~     from traffic accidents. Those who inject heroin or other opioids are considered to have the~     highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid~     antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood~     vessel. Administration of naloxone via the nose has been suggested as an alternative for use~     by emergency teams and possibly also bystanders. This is not only an easier way to give~     naloxone, but would also eliminate the risk for needle stick injuries and blood~     contamination. A pilot study in this hospital has shown no significant side effects or~     adverse reaction. While significant benefits are expected from developing an adequately~     formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal.~     Therefore this preclinical study in healthy volunteers will be undertaken.~   "
68700|NCT02158104|"~     Pain after dry needling or injection in the muscle is a frequent secondary effect in the~     treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed~     during a 72 hours follow up period. Factors that may contribute to higher levels of pain or~     sensitivity will be evaluated.~   "
68701|NCT02158091|"~     This research study is evaluating a new drug called IPI-145 in combination with the standard~     drugs fludarabine, cyclophosphamide, and rituximab (FCR), as a possible treatment for~     chronic lymphocytic leukemia (CLL).~   "
68704|NCT02158052|"~     This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or~     systemic AL amyloidosis for which hematopoietic stem cell transplantation would be~     ordinarily indicated and the reversal of end-stage renal failure, while avoiding the risks~     associated with long-term standard anti-rejection therapy used in renal transplantation. The~     primary objectives of this study are to assess renal allograft tolerance (that is, the~     acceptance of the kidney without the need for anti-rejection therapy), assess anti-tumor~     response rates in multiple myeloma and AL amyloidosis, and assess complication rates for~     genetically (HLA) matched related donor combined bone marrow and kidney transplantation~     using a low dose total body irradiation based preparative regimen.~   "
68705|NCT02158039|"~     Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical~     removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol)~     injection may treat cysts by killing the lining cells of the cyst, and is an accepted~     treatment for cysts of other organs. In this study, participants with pancreatic cysts~     underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was~     a pilot study to assess safety and efficacy.~      The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring~     hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with~     retreatment as necessary, will ablate at least 50% of pancreatic cysts.~   "
68706|NCT02158026|"~     1000 women with infertility who are already decided to be treated with ICSI will be~     subjected to full history taking and clinical examination. On the second day of menstruation~     serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count~     (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of~     follicles measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by (Human menopausal~     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)~     administration. On the day of HCG administration, ovarian ultrasound scan will be performed~     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)~     is defined as number of follicles measuring≥16mm. Follicular sensitivity index (FSI) will be~     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH)~   "
68707|NCT02158013|"~     The purpose of this study is to investigate the effect of Levorag Emulgel compared with~     diltiazem gel on the healing of chronic anal fissures.~   "
68708|NCT02158000|"~     To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in~     cases undergoing intracytoplasmic sperm injection (ICSI) cycles.~   "
68709|NCT02157987|"~     Epistaxis are present in over 90 % of patients with Rendu - Osler . They involve no~     significant difference 2 sexes. They often appear in childhood and adolescence and are~     present in three-quarters of patients at the age of 20 years. These epistaxis increasing in~     frequency and volume to the age of 60 in 2/3 of patients. Epistaxis are spontaneous ,~     repetitive and recurring . They are highly variable in duration, intensity and frequency of~     occurrence . Some patients may have more than 40 monthly episodes with mean duration of 5~     minutes of bleeding and chronic anemia and can sometimes acute anemia with transfusions need~     to be source. These epistaxis stigmatize patients and inevitably affect their quality of~     life and social skills . The various proposed ( cauterization , intra- mucosal injections,~     laser selective hémostatses , embolization or surgical dermoplasties ) allow for some~     short-term remissions . Bevacizumab is an antiangiogenic use in the treatment of colorectal~     cancers . It is also used in ophthalmology intravitreal to reduce vascular proliferation in~     glaucoma retinopathy and certain corneal neovascularization. In 2009, Prithviraj reported~     the use of bevacizumab injection to treat pulmonary arteriovenous malformations in a patient~     with Rendu - Osler . The result is doubly interesting including a saving action on epistaxis~     which decrease in frequency and duration. This communication prompted the authors to focus~     more on this medication. The product has been used in local submucosal injection intranasal~     laser was coupled with satisfactory results objectified by a decrease in the number of~     epistaxis , reducing blood transfusions and improved social lives. The use of local~     instillation bevacuzimab represents a way forward for the treatment of these epistaxis.~   "
68710|NCT02157974|"~     Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis~     compared to weight similar women with regular menses. It is unclear if this is related to~     high testosterone or insulin resistance. We will assess hepatic glucose release, rates of~     lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine~     if alterations in the processes contribute to hepatic steatosis. Subjects will be~     overweight, sedentary girls with or without PCOS who are not receiving medical therapy for~     insulin resistance, or PCOS.~   "
68711|NCT02157961|"~     This is an observational study to assess the health behavior of Physicians from medical~     practices in Germany. Physicians will be asked by a questionnaire (self-report) on health~     behavior, self-diagnostics and self-medication in case of sickness. We will send the~     questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We~     expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive~     analysis for primary outcome. Results may provide a better understanding of the Physicians~     health behavior.~   "
68712|NCT02157948|"~     This study will compare the effect of denosumab produced by two different manufacturing~     processes on bone mineral density at the lumbar spine in postmenopausal women with~     osteoporosis.~   "
68713|NCT02157935|"~     Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing~     exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
68714|NCT02157922|"~     The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder~     formulation, in adult subjects with cystic fibrosis.~   "
68715|NCT02157909|"~     The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere~     modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit~     by comparing the percent of subjects satisfying the no re-fit criteria in each treatment~     group.~   "
68800|NCT02156804|"~     The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0~     Grade 3 or higher), treatment-related, select adverse events in subjects with histologically~     confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment~     containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with~     Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.~   "
68716|NCT02157896|"~     Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after~     cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role~     in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators~     sought to compare the expression of VEGF and ES in serum and the circulating EPCs in~     patients after AIS with that of healthy control subjects. The investigators obtained~     peripheral blood and serum samples from study subjects. EPCs in blood samples from AIS~     patients and healthy controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7~     days after AIS. VEGF and ES were measured by enzyme linked immunosorbent assay at the same~     time points. The relation between them and the relation of them to prognosis of such~     patients with acute ischemic stroke were assessed.~   "
68717|NCT02157883|"~     This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose~     disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy.~     Part A will assess the effect of multiple oral doses of itraconazole on the single dose~     pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue~     to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19~     if they and the Investigator deem it appropriate, until such time as their disease~     progresses, the Investigator believes they are no longer deriving clinical benefit, or they~     stop taking AZD9291 for any other reason.~   "
68718|NCT02157870|"~     Multi-Phase study (I/II) that did not progress to Phase II of clinical trial, terminated~     early due to low accrual, separate ClinicalTrials.gov Registration NCT00102622 for Phase I~     of study:~      Phase I:~        -  Enrollment of up to 24 subjects in 8 cohorts of three subjects to one of three~          combinations of intraperitoneal (IP) tgDCC-E1A + intravenous (IV) paclitaxel by the~          continuous reassessment method (CRM) will be sufficient to establish the MTD~        -  The single agent paclitaxel cohort will consist of 24 subjects~      Phase II:~        -  Enrollment of up to 20 subjects to one of three combinations of IP tgDCC-E1A + IV~          paclitaxel decided by Phase I.~        -  The single-agent paclitaxel cohort will consist of 20 subjects.~   "
68719|NCT02157857|"~     The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect~     lymph node metastases in lung cancer patients using EBUS-TBNA samples.~   "
68720|NCT02157844|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an~     obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia~     and re-oxygenation, which lead to increased oxidative stress, increased inflammation,~     endothelial dysfunction, and insulin resistance. Chronic obstructive pulmonary disease~     (COPD) is a lung disease that leads to poor airflow. This disease leads to systemic hypoxia,~     reduced oxidative capacity, and increased inflammation. The direct cause of OSA and COPD is~     unclear, but OSA and COPD may be linked to other comorbid conditions such as obesity and~     type II diabetes. Upon onset of OSA and COPD, metabolic disturbances associated with obesity~     and type II diabetes can be exacerbated.~      Obesity is a condition characterized by an increase in visceral fat, elevated plasma levels~     of free fatty acids, inflammation, and insulin resistance. Although the effects of body fat~     distribution have not been studied in these patients, an increase in both subcutaneous and~     abdominal fat mass in non-OSA older women was shown to increase morbidity and mortality.~     Fat/adipose tissue is an active tissue capable of secreting proinflammatory cytokines such~     as tumor necrosis factor (TNF)-alpha and interleukin (IL)-6, reactive oxygen species and~     adipokines. Particularly, abdominal fat is a prominent source of pro-inflammatory cytokines,~     which contributes to a low grade, chronic inflammatory state in these patients.~     Additionally, an increased inflammatory state is associated with reduced lean body mass, and~     together with elevated circulating free fatty acids may increase the occurrence of~     lipotoxicity and insulin resistance. Thus, increased fat deposition is associated with a~     poor prognosis in OSA and COPD patients and therefore it is of clinical and scientific~     importance to understand the changes in fat metabolism and digestion as a result of OSA and~     COPD.~      It is therefore our hypothesis that fat synthesis and insulin resistance is increased and~     whole body protein synthesis is decreased in OSA and COPD patients, leading to a poor~     prognosis.~   "
68721|NCT02157831|"~     Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol~     UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on~     UPCC 10903 intravenously.~   "
68722|NCT02157818|"~     1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for~          patients. In non-surgical approaches, benzodiazepines are broadly used for ideal~          sedated status for patients.~             -  However, especially in bronchoscope procedure, continuous monitoring of oxygen~               saturation is needed to prevent hypoxia due to respiratory distress induced by~               benzodiazepine.~             -  A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has~               less adverse effect of respiratory distress compared to previous agents, was~               introduced.~        2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of~          midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).~             -  Double blind randomized trial~             -  Primary outcome: The number and duration of desaturation, volume of sedative, any~               use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and~               hypertension, tachycardia, any need for mandible support or manual ventilation,~               and any need for intubation (for safety).~   "
68723|NCT02157805|"~     This project aims to assess the impact of technological processes of meat, as cooking~     conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that,~     even if meat is considered as a good provider of fast proteins and so could be useful to~     prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and~     amino acids bioavailability for muscle synthesis.~   "
68724|NCT02157792|"~     An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK)~     of VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors~   "
68725|NCT02157779|"~     Excessive and poorly controlled anger is one of the most common problems experienced by war~     Veterans. The consequences can be severe, including increased risk for divorce, domestic~     violence, job loss and instability, and other serious impairments in family, social, and~     occupational functioning. Availability of effective treatments is critical to reducing the~     adverse effects of anger in Veterans. The investigators propose to conduct a controlled~     study to determine whether a cognitive behavior treatment that has been adapted for treating~     anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to~     a supportive therapy. Results will be examined for improvement in anger, functioning, and~     quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.~   "
68801|NCT02156791|"~     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.~     The purpose of this clinical trial is to confirm the safety, clinical tolerability and~     immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with~     grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated~     dose of gpASIT+TM .~   "
68726|NCT02157766|"~     The Wisconsin Center for the Neuroscience and Psychophysiology of Meditation will be a~     highly focused center dedicated to novel and cutting edge research on the mechanisms by~     which meditation works. The core set of hypotheses for this Center focus on the mechanisms~     of two common meditation practices: Mindfulness Meditation (MM) and~     Loving-Kindness/Compassion Meditation (LKM-CO), both taught in Mindfulness-Based Stress~     Reduction (MBSR). The investigators will study both Long-Term Meditators (LTMs) as well as~     meditation-naïve participants (MNPs). The latter group will be randomly assigned to MBSR, a~     rigorously matched comparison intervention called the Health Enhancement Program (HEP;~     MacCoon et al., 2012), or to a Wait List (WL) control group. This will give us a~     comprehensive view of changes that are produced by meditation practices per se, changes~     generically associated with interventions designed to promote well-being, and changes that~     might be effects of repeating testing protocols across multiple occasions. In addition, the~     inclusion of both novice and experienced meditators provides a wide range of practice~     experience that will provide critical information on dose-related effects, information that~     is lacking in the research literature today.~      Each of the projects is focused on examining the brain mechanisms and peripheral biological~     correlates of meditation. Project 1 (Davidson) will examine the impact of the explicit use~     of mindfulness and loving-kindness/compassion strategies on emotion regulation, specifically~     neural, biobehavioral and hormonal indices of reactivity to and recovery from pictures of~     human suffering and flourishing. Project 2 (Busse) will investigate the brain to periphery~     pathways through which psychological factors contribute to the expression of asthma~     symptoms. In addition, it will examine the efficacy of meditation training in reducing the~     inflammatory response to an allergen in asthmatic individuals by reducing the reactivity of~     emotion-related neural circuitry. Project 3 (Tononi) will examine whether the previously~     reported increase in gamma oscillations during Non-REM (NREM) sleep in meditators is~     associated with changes in sleep mentation (Ferrarelli et al. 2013). In addition, project 3~     will examine relations between meditation-induced changes in brain activity during sleep and~     brain activity and cognitive function during wakefulness.~   "
68727|NCT02157753|"~     As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after~     about 500 fracture patients hospitalized with an age over 50 years a year. First, we were~     interested in the effective rate of osteoporotic fractures in this cohort. As to this~     objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a~     diagnostic pathway for every patient over 50 years of age with a fracture, including dual~     energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning~     osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a~     laboratory workup focusing on this topic. Considering all these information we sent a~     detailed therapy-plan to the responsible General practitioner.~      The main goal of this study is to verify the persistence and compliance of the osteoporosis~     therapy 12-15 months after fracture and to clarify any obstacles potentially impeding~     therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.).~     The investigators use a postal questionnaire provided to the patient and the general~     practitioner. Data collection is undertaken by a study nurse, in addition phoning for~     missing data by phone-call. With the aim to ameliorate the implementation of treatment,~     patients and general practitioners will be provided with the specifically tailored~     information found to be missing.~   "
68728|NCT02157740|"~     The purpose of this study is to determine whether teleconsulting would be effective and~     cost-effective by reducing the patients transportations and the use of emergency units for~     nursing home residents requiring emergent or elective care.~   "
68729|NCT02157727|"~     The purpose of this study is to determine whether telemedicine would be as effective as~     having a pediatrics ophthalmologist on site for screening examination of retinopathy in~     premature infants and would be cost-effective.~   "
68730|NCT02157714|"~     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics~     and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.~   "
68731|NCT02157701|"~     This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with~     exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule~     compared to placebo capsule in improving exercise capacity and overall parameters of joint~     health.~   "
68732|NCT02157688|"~     The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on~     scalp. This disease is currently not curable, responsible for significant for patients. The~     pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role,~     never previously studied, and the study will attempt to clarify it.~      Controversies in the literature on the pathophysiological hypotheses can be summed up as~     follows :~      FD is it an infectious folliculitis where SA (almost always found on the lesions plays a~     direct role possibly aided by a lack of local immune protection , or is it a pustular~     inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple~     germ superinfection.~      Our study has plans to bring new evidence to help decide between these two opposite but not~     mutually exclusive concepts .~   "
68733|NCT02157675|"~     This study is a randomized, double-blind, placebo-controlled, crossover design study in~     healthy subjects to determine the effects of a polyherbal supplement on the signs and~     symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.~   "
68734|NCT02157662|"~     The risk of developing clinical manifestations of ischemic heart disease is currently~     assessed by using integrated multifactorial prediction models based on the presence of~     non-modifiable risk factors, such as age, gender and a family history of early ischemic~     heart disease along with risk factors which are defined as conventional, such as arterial~     hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.~      However, if the relationship between risk factors and ischemic heart disease clinical~     manifestations shows some limitations, the relation between risk factors and the coronary~     atherosclerosis process underlying most ischemic syndromes seems to be even weaker.~      In fact there is significant individual variability and the limits of such relationship are~     demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the~     prediction model. At one outlier, in the presence of multiple risk factors, these subjects~     do not develop neither coronary events nor coronary atherosclerosis whereas, at the other,~     coronary events and disease occur in the absence of risk factors.This study aims at~     detecting new protection and susceptibility factors, thus enabling to formulate new~     etiopathogenetic hypotheses concerning coronary atherosclerosis and to identify new~     therapeutic targets.~   "
68735|NCT02157649|"~     The objectives of this study are (a) to determine if drug levels from a single dose of an~     extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given~     every four hours containing lower doses considered safe for over-the-counter use; (b) to~     evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet~     after a single administration; and (c) to assess the safety and tolerability of the~     Codeine/Guaifenesin extended-release and immediate release tablet formulations.~   "
68737|NCT02157623|"~     The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic~     Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell~     carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an~     FDA-approved method widely used currently for squamous precancers of the skin. The~     investigators hypothesize that PDT will provide exceptional benefit in the BCNS population~     because PDT is nonmutagenic, nonscarring, and can be safely repeated many times.~     Additionally, the study will investigate whether there are any differences in tumor~     clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.~   "
68738|NCT02157610|"~     The goal of this research study is to compare a program called Motivation And~     Problem-Solving (MAPS) to the standard treatment to help participants with a history of~     cervical cancer to quit smoking.~   "
68739|NCT02157597|"~     Heart surgery in young children involves some risks. This study looks at a new type of~     monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to~     measure if enough blood reaches vital organs in the body. The investigators goal is to see~     if this shows problems developing sooner than usual. The investigators do not know at this~     time if they can improve the blood supply to the vital organs. The investigators main aim is~     to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug~     Administration (FDA).~      The investigators will also follow the progress of recovery after surgery in the Cardiac~     Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the~     outcome for children.~   "
68740|NCT02157584|"~     This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of~     telotristat ethyl and its metabolite LP-778902 relative to administration of single dose~     telotristat etiprate in the fasted state in healthy adult male and female subjects.~   "
68741|NCT02157571|"~     The purpose of this study is to use oral prulifloxacin to treat patient with Acute~     Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.~   "
68742|NCT02157558|"~     The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on~     the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.~   "
68743|NCT02157545|"~     Pyridostigmine is a medication that is used in certain heart rate and blood pressure~     conditions. This medication, as a side effect, is known to also cause changes in the~     junction between a nerve and muscle. The changes caused at the nerve muscle junction by~     pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery~     and anesthesia). The investigators are conducting this study to see whether patients taking~     pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used~     during surgery).~   "
68744|NCT02157532|"~     Stroke constitutes the primary cause of acquired disability in adults and the second cause~     of dementia following Alzheimer disease. It has been shown that patients with a moderate to~     severe clinical score have occlusion of brain large vessels, resulting in a worse clinical~     outcome. Many studies have demonstrated that early recanalization after IV rtPA is more~     restricted, the larger and more proximal the artery. Several systems for mechanical~     intracranial arterial thrombectomy of large trunks have recently been proposed and are now~     available. Potential advantages of these mechanical systems on chemical thrombolysis are~     speed (a few minutes versus 1 hour) and absence of thrombolytic injection.~      The objective of the EASI trial is thus to:~        -  To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke~          in patients treated with IV thrombolysis or in patients for whom thrombolysis is~          contra-indicated.~        -  To determine whether a combined approach, standard treatment plus thrombectomy, is~          superior to standard treatment alone within 5 h of the appearance of symptoms, in~          patients with occlusion of proximal cerebral arteries following moderate to severe~          stroke (NIHSS larger than or equal to 8), evaluated at 3 months.~      The design is a randomized, controlled multicentric trial, with a parallel comparison~     between standard and combined (standard plus thrombectomy) treatment.~      480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary~     hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or~     equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment~     at 3 months.~      IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is~     carried out with already approved devices, according to the manufacturer's instructions,~     following a diagnostic cerebral angiography.~      The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3~     months.~      The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage~     at 24 hours.~      If the primary hypothesis is validated, expected benefits of this study is a higher rate of~     autonomy for stroke patients with all the attendant consequences: reduction in hospital~     stays, and a faster return to the activities of daily life.~   "
68745|NCT02157519|"~     Many people treated for cancer receive oral chemotherapy medications for their illness. This~     means that much of their cancer care occurs at home, away from a traditional oncology care~     setting. The purpose of this study is to explore how a smartphone mobile application~     (mobile app) can help improve the cancer treatment process in people who are prescribed~     oral chemotherapy medication. The investigators will explore how well the mobile app helps~     patients stay connected with their oncology care team, take their oral medications as~     prescribed, and manage their cancer-related symptoms from home. This study will be done in~     two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention,~     and 2) a randomized-controlled trial to test the intervention.~   "
68746|NCT02157506|"~     A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of~     CXL-1427 in hospitalized patients with systolic heart failure.~   "
68747|NCT02157493|"~     This study will use a randomized controlled design to evaluate whether a youth~     entrepreneurship/life-skills intervention for reservation-based American Indian adolescents~     (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes~     from baseline for up to 3 years follow-up as compared to a recreational sports league~     control condition.~   "
68755|NCT02157389|"~     Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological~     rather than psychological interventions. Moreover, only few studies examined patients or~     tested how previous experience and attitudes affect placebo and nocebo responses. On the~     psychological level expectancy and classical conditioning have been identified as two~     primary mechanisms. Both seem to be important with classical conditioning potentially having~     more long-term effects and expectancy being more important in nocebo effects. There is some~     initial evidence from the investigators own research that patients may be more prone to~     these effects and the investigators have also shown that placebo effects may last up to~     several years after treatment. The investigators therefore examine previous attitudes to~     pharmacological interventions for chronic pain in patients with chronic back pain and~     subdivide them into groups with high of low belief in the respective treatment modality. The~     investigators then apply a pharmacological placebo and study the interaction between the~     prevailing attitude (implicit and explicit) and the placebo effect with respect to pain~     perception but also to neurobiological mechanisms using functional magnetic resonance~     imaging. In addition to expectancy, conditioning of placebo will be examined and the~     long-term effects of the intervention will be determined.~   "
68748|NCT02157480|"~     Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the~     cornerstone treatment for patients with T2D who are often overweight and sedentary.~      Physical activity improves glucose metabolism of patients with T2D : increased glucose~     utilization during acute muscle activity and improved insulin sensitivity after regular~     training. The molecular mechanism underlying the effects of exercise on glucose metabolism~     involves the glucose transporter GLUT-4 which is regulated by physical activity.~      Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6%~     on average. In addition, other data suggest a decrease in cardiovascular morbidity and~     mortality through physical activity.~      Recent recommendations for T2D management call for the practice of a structured type of~     endurance 150 minutes per week and muscle building 2 times per week. However, implementation~     of these recommendations is low, even when integrated into a therapeutic education program.~     Adherence is often transient and / or partial. In addition, many T2D subjects are unable to~     initiate a physical activity because of disabling complications or comorbidities or because~     of a major cardiorespiratory deconditioning.~      Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional~     rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been~     little studied. A pilot study conducted by our team on a population of 18 subjects with T2D~     showed that a week of daily NMES sessions significantly improved insulin sensitivity of~     about 25% and up to 50 % for good responders. This result contrasted with the low induced~     energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the~     possibility of a humoral or neural mechanism associated with NMES.~      To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without~     NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES~     per week) to assess the glucose profile of sedentary T2D subjects during these different~     periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D~     subjects and thus represent an alternative to traditional physical activity.~   "
68749|NCT02157467|"~     The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of~     coadministered oral contraceptives.~   "
68750|NCT02157454|"~     Being diagnosed with cancer confronts patients with a severe disease and they need to learn~     to deal with a range of new challenges. In order to support patients in the coping process,~     the website www.krankheitserfahrungen.de provides patients free, reliable information about~     health issues by sharing peoples' real-life experiences. In our project, the investigators~     developed a new module on the website for patients with colorectal cancer.~      The objective of our study is to evaluate if access to the new colorectal cancer module on~     the website www.krankheitserfahrungen.de increases patient's competence.~      The investigators will conduct a two-arm randomized controlled trial. Patients affected by~     colorectal cancer will be randomized into an intervention and a control group: the~     intervention group will have access for two weeks to the website~     www.krankheitserfahrungen.de (colorectal cancer module) with cancer patients´ experiences.~     Patients in the control group will not receive any intervention but will have access to the~     website for two weeks after completing the study.~      Patient competence is measured by the self-efficacy component of the German short form of~     the Cancer Behavior Inventory via an online questionnaire at baseline and after two weeks. A~     second follow-up assessment will be implemented six weeks after baseline.~   "
68751|NCT02157441|"~     Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral~     uterine artery ligation and compression of the lower uterine segment at the same time with~     one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage~     in women with placenta previa complete centralis. Method: This prospective study of 50 women~     with postpartum hemorrhage following removal of placenta previa complete centralis during~     elective cesarean section. All 50 patients will have lower uterine compression sutures~     (involving bilateral uterine artery ligation and compression of the lower uterine segment at~     the same time with one circular stitch). All patients will be followed postpartum for~     evaluation of uterine cavity and menstrual cycles~   "
68752|NCT02157428|"~     Background and objectives: The inhalational anesthetic isoflurane is widely used in general~     anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino~     butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil,~     benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could~     therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and~     early anesthetic recovery reduce morbidity and incidence of complications. The objective of~     this trial is to determine whether the use of flumazenil may contribute to faster recovery~     from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with~     isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were~     randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two~     groups. The anesthetic technique was standardized. The groups were compared concerning~     values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from~     the application of flumazenil or placebo until 30 minutes after injection. Data regarding~     time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and~     Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results,~     considering p <0.05.~   "
68753|NCT02157415|"~     It is the first clinical study aimed at assessing the safety and tolerability of UT-P as~     routine rinsing and bacterial decolonization solution device for urinary catheters. The~     study will be conducted in hospitalized adult patients who had an urethral or suprapubic~     catheter in place for longer than two consecutive weeks and who are able to provide written~     consent.~      This is an open-label prospective observational cohort study. No comparative control group~     is planned as no other preventing infection solution is commercially available at this time.~   "
68754|NCT02157402|"~     Our hypothesis is that healthy lifestyles improvement by an intervention designed according~     8 social marketing Benchmark criteria, can reduce overweight or obesity implemented by~     adolescents on their colleges.~      The general aim of EYTO program is to improve health and well-being among adolescents who~     live in low socioeconomically communities, through an intervention study designed by~     selected adolescents with the inclusion of social marketing Benchmark criteria.~   "
68756|NCT02157376|"~     The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously~     demonstrated prevention of bleeding events) during treatment period in proportion of~     patients for the prevention of upper GI bleeding.~   "
68802|NCT02156778|"~     Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of~     developing post-stroke complications. There is a substantial gap between risk factor~     management in real life and that recommended by international guidelines. Stroke Card is a~     multifaceted comprehensive post-stroke disease management program to detect and treat~     complications and optimize secondary prevention. The investigators hypothesis that, compared~     to standard care, Stroke Card will lead to an at least 13.3% risk reduction in recurrent~     cardiovascular events and improve health-related quality-of-life.~   "
68757|NCT02157363|"~     Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for~     resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine~     position for the abdominal part and in a left-lateral decubitus (LLD) position for the~     thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of~     the present study is to compare peri- and postoperative outcome variables after TAE for~     esophageal cancer in the two positions.~      POETRI is designed as a single-center, randomized controlled trial with two parallel arms~     including patients with resectable esophageal cancer and type I cancers of the~     esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or~     both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant~     pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity,~     lymph node yield, pulmonary function, pain control and wound healing assessed during a~     follow-up of 3 months.~      POETRI is a single-center, randomized controlled trial to evaluate different positioning and~     thoracic access during radical open thoracoabdominal esophagectomy for patients with~     resectable esophageal cancer.~   "
68758|NCT02157350|"~     The purpose of this study is to determine the threshold level of proliferative diabetic~     retinopathy progression and regression after standard panretinal photocoagulation.~     Predictors of progression and regression will be identified which will include retinal~     vessel geometry (caliber, fractals and tortuosity), retinal vessel oxygen saturation and~     retinal areas of non-perfusion.~   "
68759|NCT02157337|"~     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.~     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and~     postoperative mortality. Aortic surgery is the most risky surgery that causes the~     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.~      Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is~     used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect,~     statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress,~     recovery of endothelial cell injury and stabilization of thrombus.~      The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow~     but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and~     oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to~     decrease after the perioperative use of statin because of the pleiotropic effects of it. The~     aim of this study is to examine the association between preoperative statin treatment and~     the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic~     surgery~   "
68760|NCT02157324|"~     This study is evaluating the safety and efficacy of the combined use of acalabrutinib and~     ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)~   "
68761|NCT02157311|"~     Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on~     treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable~     viral load for at least 12 months and continuous antiretroviral regimen unchanged for at~     least 4 months, to maintain a therapeutic success defined by the absence of virological~     failure (2 consecutive viral loads > 50 cp/mL) and the absence of interruption of~     therapeutic strategy (interruption or change of the  4 days on / 3 days off  strategy for~     a time longer than 30 consecutive days).~   "
68762|NCT02157298|"~     Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with~     inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and < 11% will be~     enrolled into the wash-out phase or directly into the lead-in phase depending on whether the~     patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1~     agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as~     part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl~     Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be~     randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the~     dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects~     who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open~     extension treatment period.~   "
68763|NCT02157285|"~     This is a prospective, randomized-controlled trial in which subjects will be randomized to~     receive either routine contraceptive counseling or peer mentoring plus routine contraceptive~     counseling.~   "
68764|NCT02157272|"~     Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of~     Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR~     2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute~     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings,~     and death in triple aPL-positive APS patients.~      Study Design A multicentre, interventional, prospective, parallel, randomised, controlled,~     open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency)~     vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients~     in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional~     Review Board will approve the study.~      Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid~     syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are~     eligible for this study.~      Primary Outcome variables The primary cumulative outcome measure will be incident acute~     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or~     death.~      Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and~     all-cause death.~      04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.~   "
68765|NCT02157259|"~     This is an observational study to identify the etiology, management, and outcome of~     community-acquired sepsis and severe sepsis in children and adults in Southeast Asia. The~     study will take place in Thailand, Vietnam, and Indonesia, the partner countries of SEAICRN.~     Potential study patients will be any patients (both children and adults) who are presented~     at the hospital with community-acquired sepsis or severe sepsis and require hospitalization.~   "
68797|NCT02156843|"~     The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg~     BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.~   "
69871|NCT02142829|"~     This study was conducted to compare the effectiveness of two local pain control methods in~     bariatric patients by assessing the amount of postoperative pain and amount of postoperative~     pain medications needed. This information was used to determine which local anesthetic~     provided the best pain control.~   "
68766|NCT02157246|"~     A low level of oxygen in cancer cells makes them less likely to respond to chemotherapy and~     radiotherapy treatments. There is interest in using new drugs that improve the level of~     oxygen in tumours. Another approach would be to increase the radiotherapy dose to tumours~     with low oxygen levels.~      Before we can do this for patients with rectal cancer, we need to develop a reliable way of~     identifying areas of low oxygen within the rectal tumour. This will make us able to tell~     which patients may be suitable for such a change in their treatment.~      Traditionally, the level of oxygen in tumours is measured by inserting a needle into the~     tumour and measuring it directly. This is not possible in rectal cancer. This study has been~     designed to identify the best alternative method. We would like to do a blood test, take~     samples of cancer tissue and some detailed scans (18F-fluoromisonidazole (F-MISO) positron~     emission tomography, perfusion computed tomography, functional magnetic resonance imaging).~     The results of these tests will be compared to decide which gives us the most comprehensive~     and reliable information.~      Patients in Group A go straight to surgery. By looking for markers of low oxygen levels on~     the tumour that has been removed, we will be able to find out which of the study tests~     performed before the tumour was removed is the best. By repeating the scans we will be able~     to see how reliable they are and how much they change on a day to day basis. We think that~     tumours that still have low levels of oxygen after 8 to 10 doses of radiotherapy are the~     least likely to respond to treatment.~      Group B will have scans before radiotherapy treatment and after 8 to 10 doses of~     radiotherapy to see if we can identify the patients that have persistent low levels of~     oxygen.~   "
68767|NCT02157233|"~     The potential of physical activity and other non-medicinal methods for the care and~     prevention of metabolic and cardiovascular disorders has been insufficiently used. There is~     a potential influence of environmental heat in energetic balance regulation. However, the~     existing knowledge is insufficient to optimize physical activity programs based on the~     impact of exercise on energy intake regulation in hot climates. The aim of the present study~     is to define the major physiological determinants of short-term food intake regulation in~     young active and healthy men, when exposed to different levels of metabolic activity and~     environmental temperatures. We will thus explore the biological mechanisms related to~     post-exercise relative energy intake. Post-rest and post-exercise energetic compensation~     will be analysed in these different environmental conditions, with a special focus on the~     effect of the birth weight. This study should open interesting ways to define adequate~     nutritional and exercising programs in hot environments.~   "
68768|NCT02157220|"~     This is a randomised control trial comparing two different prosthetic designs used in total~     knee arthroplasty. Participants were randomised to receive either of the two prostheses and~     then were followed up of a period of 7 years, looking at pain, range of motion and impact on~     quality of life. The literature and joint registry of Australia shows that one of the~     prosthesis may be inferior to the other. Our research team hypothesised that this was not~     the case and that previous elicited differences were related to other factors.~   "
68769|NCT02157207|"~     This research is,being done to better understand how antioxidants (vitamins C, E and Alpha~     Lipoic Acid) af,f,ect the heart,and arteries. For this study, we will obtain blood samples~     to measure oxidative stress markers (substances in the blood that are linked to oxidative~     stress), cholesterol, insulin and blood glucose (sugar), as well as measure how well the~     heart and arteries are working following supplementation with the antioxidants.~      Our central hypothesis is that acute antioxidant supplementation will improve arterial~     function at rest and during exercise in African Americans without an impact of age, whereas~     aging will modify these effects in Caucasians.~   "
68770|NCT02157194|"~     EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular~     analysis. The purpose of this study is to evaluate if samples from on lymph node site can be~     divided for diagnosis and molecular analysis.~   "
68771|NCT02157181|"~     The study will test the effectiveness (rate of complete remissions, total remission rate and~     duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous~     cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for~     relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous~     therapy.~      CD20* = cluster of differentiation antigen 20~   "
68772|NCT02157168|"~     The investigators propose to test a community-developed and targeted intervention that~     employs community health workers (CHWs) as aides to newly Medicaid-insured women. These~     women face the challenges of engaging with their healthcare and health and of making highly~     personal and socioculturally embedded decisions about reproductive health-related preventive~     services (e.g., contraception, STI and cancer screening).~   "
68773|NCT02157155|"~     Hypothesis~        1. To define whether stimulation of ATGL and suppression of G0/G1 switch gene occur in the~          initial phases of diabetic ketoacidosis and thus can be identified as the primary~          mechanisms behind this life threatening condition.~        2. Make a human model for studying ketoacidosis.~      The investigators plan to reduce in their regular insulin over night. In the morning we~     administer endotoxin, which together with a relative lack of insulin will initiate~     ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is~     imposed by means of intravenous insulin. The testing is done two separate days with at least~     3 weeks in between and patients are admitted to hospital the evening before the day of~     testing. The investigators use isotopic tracers to determine metabolic fluxes and analyse~     fat (ATGL, G0/G1 switch gene) and muscle biopsies.~   "
68774|NCT02157142|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
68798|NCT02156830|"~     The project consists of qualitative interviews with all the members of the obesity team~     (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish~     hospitals. These interviews have the aim to gain insight into the current practice about~     counseling patients with bariatric surgery, with a focus on medication counseling. This will~     make it possible to assess the strengths and weaknesses in the current practice of obese~     patients who will undergo and have undergone bariatric surgery.~   "
70195|NCT02138552|"~     The objective of this clinical trial is to identify the most efficacious octenidine~     dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo~     in the oral cavity.~   "
68775|NCT02157129|"~     Patients after tracheostomy represent a substantial part in the ear nose throat clinic.~     Long-term intubated patients in intensive care units also profit from tracheostomy due to an~     improved respiratory toilet. However, after tracheostomy patients demonstrate shunt~     ventilation bypassing the sinonasal and pharyngeal system. The physiological moistening,~     cleaning and warming of the breathing air fail resulting in a respiratory inflammation.~     Beside a variety of supportive medical devices no general recommendation exists at present.~     Recently, we demonstrated the beneficial application of local phospholipids in Sjoegren's~     syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis.~      In the current monocentric, two-armed, double-blinded, randomized parallel group study we~     would like to evaluate the beneficial application of LipoAerosol© when compared with~     standard physiologic saline inhalation. LipoAerosol© is a licensed, tradable medical device~     and will be applied as part of its intended use. Liposomal inhalation solution provides~     moistening, cleaning and warming of the upper and lower respiratory tract and supports the~     natural moistening film in airway irritations and diseases.~      Blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion~     (Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage~     colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7,~     8, tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. In~     addition, medical examination records the number of suction maneuver (0 points: none; 1~     point: 5-10x/d; 2 points: 10-20x/d; 3 points: >20x/d), flexible-optical assessment of~     tracheo-bronchial redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points:~     tracheo-bronchial) and flexible-optical assessment of mucous congestion (0 point: none; 1~     point: fluent; 2 points: tenacious; 3 points: barky).~      Subjective estimation of the respiratory impairment will be analyzed via visual analogue~     scale (Subjective overall impairment, coughing frequency, breathlessness, mucous congestion,~     color of sputum, consistency of sputum). The study is designed without any additional~     invasive or incriminating clinical examination.~      Aim of the study is to maintain the functional integrity of the tracheo-bronchial system~     after tracheostomy using LipoAerosol© resulting in a general therapeutic recommendation.~   "
68776|NCT02157116|"~     Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less~     time between treatments than in standard chemotherapy. The two chemotherapy drugs used in~     this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when~     given every 21 days. This study is exploring the response to chemotherapy when these drugs~     are given every 14 days. In addition, genetic tests will be performed on pre-treatment~     specimens to identify signatures that may predict chemotherapy sensitivity or resistance.~   "
68777|NCT02157103|"~     STUDY BACKGROUND:~      This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA~     approved for the treatment of glioblastoma that gets worse after standard therapy. For~     glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to~     see if bevacizumab works as well when it is given as a daily subcutaneous shot as it does~     when given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The~     dose of bevacizumab given on this study is in total slightly lower than the FDA approved~     dose for glioblastoma.~      STUDY DESCRIPTION:~      About 10 people will take part in the study. Participants or caregivers will be educated on~     injection and given prefilled syringes to take home. Participants or caregivers will~     administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the~     refrigerator.~      Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks,~     the follow up interval can be increased to every 6 weeks at the treating physician's~     discretion.~      Participants can keep taking the bevacizumab until:~        -  Tests show that they are not benefiting from it,~        -  The participant has a bad side effect related to study treatment,~        -  The participant can no longer comply with study requirements, or~        -  The participant or doctor feels it is no longer in the participant's best interest.~   "
68778|NCT02157090|"~     Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and~     comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording~     additional benefits of wound protection, discretion and relief of social embarrassment. The~     aim of the actual study was the clinical assessment of the effectiveness and safety of~     Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in~     treating HSL. Both products are CE-certificated and are available at the market for medical~     devices.~   "
68779|NCT02157077|"~     The purpose of the current study is to evaluate the ability of Eylea to induce a regression~     of PED height on patients previously extensively treated by Lucentis.~      The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks~     interval injection until week 26.~   "
68780|NCT02157064|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with multiple sclerosis (MS). SVF contains~     components with regenerative properties, including stem cells that may be capable of~     ameliorating specific disease conditions. This study is designed to evaluate quality of life~     changes in individuals with MS for up to 12 months following SVF treatment.~   "
68781|NCT02157051|"~     This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic~     acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor~     receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based~     vaccine may target immunogenic proteins expressed in breast cancer stem cells which are the~     component of breast cancer that is resistant to chemotherapy and has the ability to spread.~     Vaccines made from DNA may help the body build an effective immune response to kill tumor~     cells.~   "
68782|NCT02157038|"~     This study is investigating whether changes in the shape and size of bodily muscles and~     spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC).~     The objective is to demonstrate that the presence of muscle and spinal cord degeneration and~     associated muscle weakness is the consequence of a mild MVC-related injury involving the~     cervical spinal cord.~   "
68799|NCT02156817|"~     Moderate and late preterm infants contribute to significant neonatal intensive care unit~     health care resource utilization because of their sheer numbers. Determinants of the length~     of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used~     most commonly as a predictor for LOH but there are many limitations including inaccurate~     dating and morbidities of prematurity which at least partly related to neurophysiological~     immaturity. The latter can be assessed by amplitude integrated electroencephalogram (aEEG, a~     simplified 5 lead EEG), and possibly by heart rate variability (HRV) and respiratory~     variability (RV). All 3 are non-invasive tests that can be done at the bedside. Our study~     hypothesis is to determine if neurophysiologic maturation as assessed by aEEG, HRV and RV~     within 24-96 hours following birth improves the correlation between gestational age and~     length of hospitalization compared to gestational age alone.~   "
70524|NCT02134262|"~     The purpose of this study is to evaluate the safety, efficacy and blood kinetics of~     autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in~     patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.~   "
68783|NCT02157025|"~     The majority of young children do not think that visual field (VF) testing of peripheral~     vision is similar to a game; therefore, it is not surprising that they have difficulty~     maintaining attention during VF testing and thus the test reliability suffers as a~     consequence. Poor VF reliability has been a longstanding, major issue since it leads to an~     increased number of tests and/or longer duration of time needed to determine when there are~     true vision losses. Providers are less likely to obtain VF tests in children since the~     results are of doubtful value and challenging to interpret when they are inconsistent.~     Effectively this means that children with untreated, slowly progressive eye diseases may go~     undiagnosed and incur greater visual losses. The investigators aim to create a prototype~     device that the investigators hypothesize will make VF testing more engaging for young~     children, thus increasing their attention and consistency of their responses to the test~     stimuli, which in turn should improve VF reliability. The components include a microdisplay~     video screen (1.5 diameter) as the fixation target (instead of the standard LED light)~     displaying video clips of popular cartoon characters, and audio clips of impersonated~     cartoon character voices presented by the test operator to provide instructional feedback~     based on the child's performance during testing. Improved VF reliability from the~     investigators intervention would translate to improved diagnosis and care for young~     childrens' peripheral vision loss through widespread implementation of the investigators~     innovative, affordable and readily adoptable system at eye care providers' offices.~   "
68784|NCT02157012|"~     To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis~     patients~   "
68785|NCT02156999|"~     To examine the changes of bone mineral density and bone turnover markers after Bonviva~     treatment in osteoporotic patients~   "
68786|NCT02156986|"~     The main objective of the study is to conduct a pilot study on the characterization of the~     mastication abilities of infants and toddlers using different commercial cereal based~     products in order to gain knowledge and be able to plan future studies.~   "
68787|NCT02156973|"~     Coming for a cardiac test can be a daunting experience. Despite providing written~     information sheets for patients, experience in the scanner demonstrates that many patients~     are ill-prepared when they attend for cardiac computed tomography (CT). Heart rate control~     is essential for high image quality, as this prolongs cardiac diastole (during which imaging~     occurs) and results in less motion blur, but this may be challenging to achieve in the~     context of an anxious patient. In such situations, additional radiation exposure is required~     to optimise the chances of diagnostic images. Thus, poor patient selection and preparation~     has been shown to increase the radiation burden to the patient, as well as to increase the~     rate of non-diagnostic scans, leading to patients needing additional, alternative testing.~     This can be distressing for patients and increases downstream costs for the hospital. Poor~     patient awareness is also known to increase the anxiety of attending for a test.~      Improved patient information and understanding has been shown to improve outcomes in a wide~     variety of hospital settings. Evidence from cardiac catheterisation angiography suggests~     that the use of alternative information formats can reduce patient anxiety and improve~     patient satisfaction, as well as improving their understanding of the technical requirements~     of a test. The latter may contribute to improved preparation - for example, patients who do~     not understand the requirements for cardiac CT, particularly the need for a slow heart rate,~     will often consume caffeine, stop their heart-slowing drugs, or even run or cycle to their~     appointment.~      We have agreed a collaboration with Plymouth University to create patient information videos~     for CT. These will utilise the expertise of media students (their department also runs a~     commercial arm, due to the quality of their output), in conjunction with the clinical~     requirements and patient participation groups, to create an accessible, engaging and~     informative film. We wish to evaluate the impact of this method of conveying information to~     patients on how well they are prepared to undergo testing.~      If this concept is successful, it may be of use to patients undergoing a huge range of tests~     or treatments across specialities. We therefore need to demonstrate the efficacy (or~     otherwise) of such an intervention.~   "
68788|NCT02156960|"~     It has not been well known about the changes of bone metabolic markers, bone mineral density~     and other bone-related markers after teriparatide and/or denosumab treatment in Japanese~     osteoporotic patients.~   "
68789|NCT02156947|"~     In theory, increased vascularity of GB wall could be associated with intraoperative~     findings, such as, GB wall inflammation and accompanying adhesions. There are not enough~     reports in the literature describing the correlation between GB wall vascularity and~     operative findings according to adhesion scoring scale. In this prospective clinical study,~     we aimed to highlight the correlation between preoperative power Doppler sonography detected~     GB wall vascularity and intraoperative findings - postoperative outcomes of chronic and~     acute cholecystitis patients.~   "
68790|NCT02156934|"~     This study was designed to provide confirmation of efficacy of muscle derived stem cells~     (MDCs) for the treatment of SUI in women.~   "
68791|NCT02156921|"~     This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound~     training compared to self-directed training with written handouts on subsequent performance~     on simulated patient cases and theoretical cases.~   "
68792|NCT02156908|"~     The investigators will first test, in a pilot study, the effects of 3 days of D-serine (DSR)~     on auditory plasticity in a sensory based remediation (SBR) paradigm, and then do a~     small-scale double-blind study of DSR + SBR on auditory emotion recognition.~   "
68793|NCT02156895|"~     The objective of this study is to monitor the usage of INLYTA® in real practice, including~     the adverse events associated with INLYTA®.~   "
68794|NCT02156882|"~     In this longitudinal study with a follow up time of at least 6 months, up to 300~     tuberculosis (TB) patients or TB suspects will be screened for TB using the Xpert MTB/RIF~     assay along with standard smear microscopy after Ziehl-Neelsen staining at the TB health~     clinic located at Mavalane health center. Confirmed TB cases will be followed up during TB~     therapy until month six after treatment initiation in order to obtain clinical and~     microbiological data on treatment including treatment response. Apart from relevant research~     questions in the field of TB diagnostics and treatment, the main objective of this study~     will be the development of a clinical TB research site, including capacity development in~     clinical and laboratory based TB research methods, in Mavalane, Maputo.~   "
68795|NCT02156869|"~     Although the number of recommendations against systematic screening of prostate cancer, 70%~     of patients still request testing because they overestimate the benefits and are unaware of~     the limitations.~      The investigators aim is to assess the impact of a short printed decision aid presenting~     benefits and limits of screening, on patients' intent to undergo prostate cancer screening.~   "
68796|NCT02156856|"~     Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome,~     mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or~     cardiac output due to hypovolemia or cardiac defects play a central role in causing poor~     peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive~     and non-invasive methods available. Up to the present date it is unknown, if these methods~     may by used interchangeably in patients with severe cardiac defects like aortic stenosis.~   "
68803|NCT02156765|"~     Three purpose of this study:~        1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in~          ischemic stroke patients;~        2. Evaluation on specificity and sensitivity of STAF score;~        3. Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical~          database and sample database of ischemic stroke.~   "
68804|NCT02156752|"~     This project is a randomized controlled trial to compare the efficacy of two interventions-~     one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)-~     and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All~     participants will first participate in an initial 4-month standard behavioral weight loss~     program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop;~     the ACT workshop will teach ACT skills including acceptance and mindfulness techniques~     designed to promote behavior change and health behavior persistence consistent with one's~     core values. The SR program will focus on self-regulation, regular weighing, and modeling~     behavior on successful maintainers. The WLO group will receive a control workshop focused on~     cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24~     months. The secondary outcome is change in psychological flexibility, a critical component~     of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At~     24 months, the ACT group will show significantly greater weight loss as compared to the SR~     and WLO groups.~   "
68805|NCT02156739|"~     The goal of this clinical research study is to learn if using 2 different kinds of contrast~     agents (Eovist [gadoxetate] and Gadovist [gadobutrol]) given at the same time is better than~     using 1 contrast agent alone in learning which liver lesions may be cancerous.~      Contrast agents are used by doctors in order to see MRI images more clearly.~   "
68806|NCT02156726|"~     FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold~     standard in treatment of younger and physically fit CLL patients. These excellent results,~     however, cannot be generally applied to the whole CLL population. This is because the median~     age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in~     fact account up to 50%-75 % of the CLL population. Nevertheless, such population is~     considerably underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it~     is not clear whether elderly/comorbid patients could profit from newer treatment approaches~     such as purine analog combinations or chemoimmunotherapy. Several publications demonstrated~     unacceptable toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using~     attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low~     toxicity.~   "
68807|NCT02156713|"~     Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy~     (CP). It is currently part of standard of care for children with unilateral CP, but is~     typically done one-on-one and with the child wearing a cast 24 hours a day during the~     duration of treatment. The purpose of this study is to assess the effects of an intensive~     group-based CIMT summer camp in which participants wear a removable cast on upper extremity~     function, occupational performance, and patient-specific goals. The investigators~     hypothesize that upper extremity skills and occupational performance will increase, and that~     patients will reach their individualized goals.~   "
68808|NCT02156700|"~     Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue~     stiffness. The difference in stiffness between benign and malignant tumors has been~     demonstrated by other elastography methods (acoustic radiation force impulse imaging,~     transient elastography and/or magnetic resonance elastography). The investigators~     hypothesized that benign liver tumors are softer than malignant liver tumors measured by~     SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal~     (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1)~     hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver~     tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors~     mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly~     occurring in cirrhotic liver, which can potentially influence elastographic measurements~     therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic~     liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination.~     The tumor stiffness will be measured five times for each tumor. Additionally, surrounding~     liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined~     through a standard diagnostic workup according to current guidelines, including contrast~     enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis~     the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as~     well as for benign and malignant tumors separately, and cut-off values for the~     differentiation of various groups will be derived. The clinical value of the method will be~     appraised based on specificity, sensitivity, positive and negative predictive values, and~     AUC.~   "
68809|NCT02156687|"~     The primary objective of the proposed study is to determine the difference in suturing time~     when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of~     laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.~      Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using~     the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic~     sacrocolpopexy.~   "
68810|NCT02156674|"~     This is a single center study in which Naglazyme® will be given weekly for two years in~     patients with Maroteaux-Lamy syndrome, also known as mucopolysaccharide VI (MPS VI), who~     have previously been treated with an allogeneic transplant.~   "
68811|NCT02156661|"~     The purpose of this study is to determine whether oxytocin influences emotional processing~     and learning of emotional and social stimuli.~   "
68812|NCT02156648|"~     The purpose of this project is to assess the feasibility of collecting plasma samples for~     cardiac biomarker assessment, and to identify if there is an associations between the~     biomarkers, echocardiographic features and the cardiac PET scan results (in patients~     receiving radiation therapy). This is the first step in a research program that has an~     overall goal of being able to predict early-treatment induced cardiotoxicity in patients~     with breast cancer.~   "
68813|NCT02156635|"~     The purpose of this study is to determine whether active stimulation of the affected~     hemisphere will be more effective than simulated current in treatment of stroke~   "
68814|NCT02156622|"~     The purpose of this study is to adapt depression treatment intervention for HIV patients in~     Cameroon. The PI will validate a depression severity measure, adapt key elements of the~     intervention to the Cameroon context, train nurses and physicians to carry out the~     intervention, and examine preliminary outcomes.~      Participants: Aim 1: Hospital and clinic patients, visitors, health care workers. Aim 2: No~     participants. Aim 3: HIV-infected patients. Procedures (methods): Survey instruments and ARV~     treatment.~   "
70525|NCT02134249|"~     The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in~     the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent~     intracytoplasmic sperm injection (ICSI).~   "
68815|NCT02156609|"~     The HeartMate PHP is a catheter-based pump designed to provide partial left heart~     circulatory support. The study will assess the safety and performance of the HeartMate PHP~     in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically~     unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent~     placement.~   "
68816|NCT02156596|"~     The aim of the investigators study was to evaluate the feasibility, efficacy and safety of~     nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the~     management of renal colic.~      Determine the need for systematic outpatient prescription of NSAI.~   "
68817|NCT02156583|"~     This is an observational study evaluating changes in frailty and associated impairments in~     older heart failure patients receiving left ventricular assist device therapy.~   "
68818|NCT02156570|"~     The purpose of the study is to examine whether patients who have acute or early chronic~     hepatitis C virus (HCV) infection can be treated effectively and safely with an~     interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir)~     with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this~     study will investigate whether treatment of acute or early chronic HCV can be shortened. The~     study will assess efficacy by looking at the proportion of people who clear the virus (have~     no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after~     treatment.~      The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will~     result in successful virological eradication in the majority (≥80%) of subjects treated for~     recently acquired HCV.~   "
68819|NCT02156557|"~     We are studying new ways to look for abnormal areas/tissues of the colon during a~     colonoscopy. The current scopes used for colonoscopies are very good. But if the area~     doesn't look different to the naked eye, then the scope can't improve on that. We are using~     special stains or dyes and special scopes to see abnormal areas that are hard to see with~     the naked eye. The stain or dye is fluorescent, meaning it glows when special light is~     used in the colonoscopy scope.~      You are being asked to let us spray a peptide with a fluorescent tag onto your colon.~     Peptides are small chains of amino acids (the building blocks that make up proteins) linked~     together. The peptide we use has 7 amino acids attached to a fluorescent tag (FIT C or~     Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye~     drops).~      We are testing this fluorescent peptide to see if it will stick if there are any abnormal~     areas. If the peptide sticks, it will glow when a special light in the scope is used. In~     this study, we will apply the fluorescent peptide to your colon by using a spray tube that~     fits in the colonoscope.~      This is a phase IB study. This means that although we have applied the peptide to 25 people~     in our first research study, we still need to learn more about fluorescent peptide in~     people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing~     us to test it in this study. The main goal of this study is to see if the peptide glows~     well and if we can take pictures of areas that do glow.~      This is a research study of the peptide and our ability to see it glow or fluoresce. Being~     in this study and applying the peptide won't change how our biopsies are taken or how your~     colonoscopy is done.~   "
68820|NCT02156544|"~     The purpose of this study is to investigate the safety/tolerability and~     pharmacokinetics/pharmacodynamics of CKD-519.~   "
68821|NCT02156531|"~     Research in the last fifteen years suggests that anxious individuals selectively attend~     towards threatening information. Attention modification interventions for internalizing~     adults have been developed to target cognition at this basic level; these programs have~     demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date,~     there have been minimal published studies of attention modification in youths with clinical~     levels of anxiety.~      This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit~     of this low-cost, computerized attention modification intervention (Cognitive Bias~     Modification (CBM) computer application) for anxiety disorders and symptomatology in youth~     ages 12 to 17. This trial conducted will compare three intervention arms, all of which~     include underlying treatment as usual (TAU). The investigators directly test the level of~     clinical support (scaffolding) needed to adequately deliver self-administered CBM to~     anxious youth, a finding that will be key to preparing for future deployment-focused trials.~     The investigators will compare an attention control version of the CBM program (Arm 1) to~     two active versions of the CBM intervention that have varying levels of patient clinical~     support: a self-administered CBM program that participants download and install on their~     home computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an~     adherence promotion (AP) component delivered via brief telephone calls from study coaches,~     including as needed, brief motivational enhancement and/or technical assistance~     (Self-Administered CBM+AP; Arm 3).~      The investigators expect that youth receiving CBM and CBM+AP will have improvement in~     anxiety symptoms and functioning. The investigators will also complete a cost-effectiveness~     analysis to examine potential costs offset by this intervention.~   "
68822|NCT02156518|"~     The purpose of this study is to determine if the systematic practice of Vocal Function~     Exercises (VFE) improves selected measures of voice production in participants who have~     previously been irradiated for early glottic cancers compared to participants who receive~     the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a~     prescriptive vocal exercise program (VFE) will improve the voice production of individuals~     who have been previously treated for laryngeal cancers when compared to participants who~     receive vocal hygiene alone.~   "
68823|NCT02156505|"~     Self-expandable metallic stents provide effective palliation of malignant gastric outlet~     obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor~     in-growth through the stent mesh. The Self-expandable metallic stents which has the design~     of smaller wire mesh size (double bare stent) were developed and used in Korea. This new~     design was developed to minimize the re-stenosis of uncovered stent, but the outcome is~     unknown. The end point of this study is the 8-weeks patency rate after placement of double~     bare as well as technical and clinical success rates.~   "
68824|NCT02156492|"~     The main purpose of this study is to investigate how the body responds to evacetrapib and to~     evaluate the safety and the effect of evacetrapib, alone and in combination with selected~     statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4~     weeks and part two will last up to 5 weeks, not including screening. Participants may only~     enroll in one part.~   "
68835|NCT02156349|"~     This study is a German, prospective, multicenter, controlled, cluster-randomized,~     interventional comparative study evaluating the efficacy and benefits of integrated PDM care~     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into~     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.~   "
70196|NCT02138539|"~     The purpose of this study is to evaluate the effectiveness and tolerability of an herbal~     de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to~     the other side of the face in treating mottled hyperpigmentation and melasma.~   "
68825|NCT02156479|"~     This study in a cohort of allo-HSCT recipients aims to validate the suitability of an~     improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector~     cells and its suitability to determine cut-off values mediating protection from recurrent~     CMV reactivations in allo-HSCT recipients.~      Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to~     assess the functionality of a network of clinically relevant CMV-reactive effector cells. It~     is based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated~     immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of~     CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.~   "
68826|NCT02156466|"~     This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in~     subjects with moderate to severe psoriasis to assess the safety, tolerability,~     immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple~     subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F]~     Nanobody).~   "
68827|NCT02156453|"~     Total knee replacement is one of the most successful surgical procedures in Orthopaedics.~     However, 10-20% of the patients are still dissatisfied with the results of the surgery. In~     general, the evaluation of postoperative functional outcomes are usually measured by~     self-report questionnaires, such as the Western Ontario and Mcmaster Universities~     osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to~     evaluate functional outcome of the patients is to use the performance-based tests such as~     the two-minute walk test, but there is still little information regarding its use for~     evaluating functional recovery in patients receiving total knee arthroplasty.~      The objectives this study are: 1) to assess the relationship between self-report~     questionnaires and performance-based tests among patients scheduling for TKA; and 2) to~     identify clinical variables that are associated with pre- and postoperative functional~     performance of the patients.~   "
68828|NCT02156440|"~     Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises~     the quality of life of more than 21 million North Americans. Studies on the use of~     complimentary and alternative medicines have reported that OA patients in the US are among~     the highest users of CAM. Previous studies on a unique natural mineral product SierraSil®~     demonstrated an improvement in joint health and function in subjects with mild to moderate~     OA of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in~     response to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated~     events in human cartilage. The primary objective is to assess the efficacy of SeirraSil~     Joint Formula versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™~     Osteoarthritis Index Pain subscale in subjects with osteoarthritis of the knee.~   "
68829|NCT02156427|"~     The purpose of this study is to assess the efficacy of autologous epidermal cells suspension~     grafting using a newly developed device named VITICELL® compared to placebo.~      The secondary objective is to evaluate safety of VITICELL® and global satisfaction of~     patient and investigator.~   "
68830|NCT02156414|"~     Prostate cancer is considered the fourth most common malignancy cancer in America. However,~     in Colombia the incidence is higher, and it is considered the second cause of death among~     men for malignance diseases. In the framework of clinical localized prostate cancer there is~     a controversy regarding the best predictors of risk and the best treatment options. The~     actual literature is discussing the possibility of underestimate the disease and actual~     tools are not sufficient for proper characterization. Is in this context that extended~     pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the~     real commitment of the disease. The investigators need to know the characteristics that the~     disease has on the investigators community so the investigators can generate appropriate~     therapeutic approach. Thus, the present prospective observational-descriptive multicenter~     study, want to determine in three referral centers in Bogotá Colombia , the frequency of~     pelvic node involvement in patients with localized clinical prostate cancer from the~     stratification achieved by pelvic lymphadenectomy extended.~   "
68831|NCT02156401|"~     Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT)~     and pulmonary embolism (PE) is a life-threatening disease that is associated with~     considerable morbidity and mortality. The incidence of VTE increases with age and it - as~     the third most common cardiovascular disease after ischemic heart disease and stroke -~     represents an important public health problem in industrialized countries with several~     aspects in need to be addressed.~      VTEval Project includes three long-term prospective observational studies to evaluate and~     improve VTE diagnostics and management, treatment and outcome. The aims of the project~     include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and~     subclinical aspects) and risk profiles (classic, psychosocial and environmental factors),~     using a system-oriented approach. VTEval collects three large prospective cohorts of~     patients with suspected and incident VTE consisting of individuals with a clinical suspicion~     of acute PE, individuals with a clinical suspicion of acute DVT, and individuals with~     incidental diagnosis of VTE).~      The standardized and harmonized data acquisition of the study establishes a sustainable~     resource for comprehensive research on VTE, thus providing the basis for both short- and~     long-term analysis.~   "
68832|NCT02156388|"~     This study is designed to access the safety, tolerance and~     Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in~     patients with metastatic tumors.~   "
68833|NCT02156375|"~     The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels)~     comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter~     (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration~     of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.~   "
68834|NCT02156362|"~     It is generally estimated that 5 % of patients with thyroid cancer will develop distant~     metastases, and most of them had an advanced stage of the disease at presentation. Thirty~     per cent of them are resistant to radio iodine therapy and are called refractory. Their~     long term survival is estimated to be less than 10 %.~      The objective of this study is to identify the factors associated with poor outcome in a~     cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and~     medullary thyroid carcinomas were excluded.~   "
68873|NCT02155855|"~     Investigators hope that providing patients and families with additional ways of~     communication with the diabetes care team will improve diabetes control.~   "
68836|NCT02156336|"~     The purpose of this trial is to determine if patients suffering from diabetic peripheral~     neuropathic pain treated with ranolazine will have a greater reduction in pain compared to~     placebo.~      Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical~     animal model of neuropathic pain, the investigators hypothesize that subjects randomized to~     ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.~   "
68837|NCT02156323|"~     This single center, open-label, randomized study will investigate the drug-drug interaction~     potential between multiple doses of RO7033877 and multiple doses of colistin~     methanesulfonate sodium (CMS).~   "
68838|NCT02156310|"~     Background: High blood pressure is a common complication observed in cancer patients~     prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and~     strokes, thus adversely affecting survival and quality of life in this patient group.~     However, little is known about the mechanisms leading to high blood pressure with anti-VEGF~     drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely~     empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e.~     antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic~     management and reduce the risk associated with hypertension and proteinuria in patients with~     cancer.~      Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib,~     i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure~     changes over time after commencing anti-VEGF treatment; 2) identify whether there are any~     relationships between pre-study and baseline blood pressure values, treatment with specific~     antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment;~     and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed~     either before or after commencing anti-VEGF treatment, lead to a better blood pressure~     control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses~     will be conducted to assess and identify associations and will account for other patient's~     characteristics and repeated observations over time. The investigators plan to conduct this~     study over 6 months.~      Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF~     drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time,~     inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug,~     sunitimib, will allow initial comparisons across different groups.~      The results deriving from this study will provide important knowledge on 1) patterns of~     blood pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs~     or drug classes might be better than others in preventing and managing anti-VEGF induced~     hypertension and proteinuria.~   "
68839|NCT02156297|"~     It is a prospective, non-interventional, open-label study, in order to observe the safety~     and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as~     induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the~     study from June 2014 through May 2019, with the recruitment duration from June 2014 to May~     2017. The inclusion criteria is:~        1. Definitely diagnosed as AML~        2. FLT3-ITD mutation has been confirmed~        3. Accepting the prescription of sorafenib~   "
68840|NCT02156284|"~     The objective was to compare the frequency and intensity of symptoms of fear in patients of~     preoperative cardiac surgery who received empathic behaviour from nurse or those who~     received no specific type of empathic behaviour. This is a randomized clinical trial. The~     sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two~     groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was~     assessed at two time points: before and after the intervention. The instrument used was~     developed and validated, comprising 15 defining characteristics of the nursing diagnosis~     fear. The hypothesis is that the group who received empathic behaviour from nurse will~     reduce the anxiety.~   "
68841|NCT02156271|"~     The purpose of this study is to help scientist better understand the effect of a 12-week~     single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U.~     S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep~     or staying asleep). The study will measure levels of inflammation, fasting insulin and~     fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.~   "
68842|NCT02156258|"~     This is a case collection study of breast images using standard and new mammography~     technology.~   "
68843|NCT02156245|"~     The aim of this study is to assess the efficacy of a rehabilitation protocol based on~     individualized combined eccentric and concentric cycle ergometer training compared to~     classical concentric cycle training among patients with either coronary artery disease (CAD)~     or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the~     efficacy of combined eccentric/concentric training on physical capacity and overall~     autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac~     and muscular effort and tolerance.~      The research will take place in 3 phases:~      PHASE 1 (DURATION 6 MONTHS):~      30 healthy volunteers will be included to test tolerance to personalized exercise on an~     eccentric cycle ergometer.~      PHASE 2 (DURATION 6 MONTHS):~      15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from~     chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.~      PHASE 3 (DURATION 24 MONTHS):~      A total of 169 patients split into 2 parallel groups will be included: a group receiving~     conventional rehabilitation (group A) and the other group receiving eccentric exercise~     combined to conventional rehabilitation (group B).~      Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).~      COPD patients: 76 patients will be included (38 patients per group).~   "
68844|NCT02156232|"~     The purpose of this study is to determine whether transjugular intrahepatic portosystemic~     shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective~     in the prevention of refractory hepatic encephalopathy (HE).~   "
68845|NCT02156219|"~     The purpose of this study is to determine whether the separation of men and women in the~     metro of Mexico City leads to an improvement in the violence and perception of violence~     towards women.~   "
68846|NCT02156206|"~     The purpose of this study is to determine whether the 123 women emergency phone line of~     Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in~     their psychological wellbeing and attitudes towards violence.~   "
68847|NCT02156193|"~     Although endoscopic colonic polypectomy has been an established procedure for two decades,~     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the~     presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine~     injection have been proposed in the management of postpolypectomy bleeding in large colonic~     polyps. For prophylactic clip, there was no randomized controlled study assessing the~     efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So~     the investigators designed a randomized controlled trial to confirm the efficacy of~     application of prophylactic clip in the prevention of postpolypectomy bleeding in large~     polyps.~   "
70755|NCT02131220|"~     The purpose of this study is to determine whether intracoronary selective thrombolysis are~     more effective than tirofiban on the coronary flow during primary percutaneous coronary~     intervention for the acute myocardial infarction.~   "
68848|NCT02156180|"~     In this study the Investigators aim to determine specific volatile compounds present in~     breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before~     and after tumour resection or before and after chemotherapy +/- radiotherapy using gas~     chromotography-mass spectrometry. The Investigators hypothesize that study participants with~     a tumour will display a distinct set of volatile organic compounds than can serve as~     potential cancer biomarkers.~   "
68849|NCT02156167|"~     The purpose of this study is to evaluate the effect of the sound processor upgrade from the~     C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor~     for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability~     of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810~     Sound Processor for the Codacs™ system, to collect long term data, to evaluate the~     acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability~     of the Codacs™ Test System.~   "
68850|NCT02156154|"~     Some patients have respiratory depression (decreased breaths per minute) after surgery.~     Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of~     this study is to determine if acetaminophen decreases respiratory depression after surgery.~     The investigators will also evaluate the cost effectiveness of acetaminophen.~      Patients having elective major abdominal surgery are being asked to participate in this~     research study. If eligible, a patient will have their baseline tidal volume (amount of air~     moved into or out of the lungs) and vital capacity (how much air the lungs are capable of~     holding) measured using a spirometer (apparatus for measuring the volume of air inspired and~     expired by the lungs) measured before surgery. Three questionnaires will also need to be~     completed before surgery.~      The patient will then be randomized, like flipping a coin, to receive either Acetaminophen~     or placebo (inactive substance) as an infusion throughout surgery and for the first two days~     thereafter. Neither the patient nor his or her physician will know if the patient is~     assigned to study drug or placebo. Regardless of study assignment, both groups will receive~     standard pain management medications and sedation.~      After surgery, the patient's blood pressure, activity, posture, respiratory rate, the~     electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and~     respiratory rate will be continuously monitored and recorded for 48 hours using a wireless~     pulse-oximeter and a respiratory volume monitor.~      48 hours after surgery the patient will be asked to complete a patient satisfaction~     questionnaire, which will allow the patient to rate the satisfaction with the treatment~     received for pain. The patient will also be asked to complete a questionnaire about~     recovery.~      At discharge, the patient will be given two questionnaires about pain and quality of life.~   "
68851|NCT02156141|"~     We want investigate if high intensity training can increase daily functionality without~     causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if~     there is a difference in effect with supervised and unsupervised training. Furthermore we~     want to study if a supervised training program will motivate participants to continue~     training by the end of the program.~   "
68852|NCT02156128|"~     The aim of this study is to examine if repetitive computerized cognitive training improves~     working memory in patients who are on sick leave due to complex symptom disorders (chronic~     pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of~     cognitive control training transfer to other tasks.~   "
68853|NCT02156115|"~     Background:~      - Lymphatics are a type of vessel, similar to arteries and veins. Lymphatic disorders happen~     when these vessels don t work properly. Researchers want to look for a relationship between~     lymphatic disorders and variations of certain genes found in the lung, blood, and other~     places in the body.~      Objective:~      - To learn more about lymphatic disorders and evaluate how genetic factors affect lymphatic~     disorders.~      Eligibility:~        -  People ages 2 90 who have a lymphatic disorder or relatives of people with lymphatic~          disorders.~        -  Healthy volunteers 18 and older.~      Design:~        -  Participants may have 1 2 visits a year, or more as needed. The study is expected to~          last 5 years. Visits may last 1 5 days. Participants may have lab tests, medical~          history, and physical exam at each visit.~        -  Participants may have blood testing that includes genetics tests, and urine tests. They~          may have nose and throat cultures, saliva collection, and cheek swabs to collect~          samples.~        -  Participants may have a skin biopsy and have blood taken from an artery.~        -  Participants may have breathing tests and be studied while exercising.~        -  Participants may have an electrocardiogram. Electrodes will be placed on their chest,~          tracing heart rhythms. They may also have chest X-rays.~        -  Participants may have a bronchoscopy. A thin, flexible instrument will be passed~          through the nose or mouth, into the lung. A tissue sample will be taken.~        -  Participants who have lymphatic disease or have a relative with it may also have:~        -  CT scans. They will lie on a table and hold their breath while their chest is scanned.~        -  MRI. They will lie flat on a table that slides in and out of a scanner.~        -  ultrasound. A probe is rolled around outside the abdomen.~        -  removal of fluid around the lungs, chest, and abdomen.~   "
68854|NCT02156102|"~     Background:~      - People with sickle cell disease and other blood disorders sometimes get chronic leg~     ulcers. These are wounds that develop on the skin and don t go away. Current treatments do~     not work very well, so researchers want to learn more about why the ulcers happen. They want~     to find out which bacteria may cause it, and if external factors play a role.~      Objective:~      - To study social and environmental factors of sickle cell disease and the causes of sickle~     cell disease leg ulcers.~      Eligibility:~      - People age 18 and older who have sickle cell disease or another red cell disorder, with or~     without an active leg ulcer.~      Design:~        -  Participants will have a medical history and clinical evaluation. They will also have~          blood drawn.~        -  Participants will complete questionnaires about their life, health, environment,~          stress, and other topics.~        -  Participants may provide a small sample of hair.~        -  Participants will be asked to collect a small amount of saliva.~        -  Participants with leg ulcers will have their skin microbiome sampled. The microbiome is~          all of the microbes (bacteria and and/or fungi) and their genes in and on the body.~          Researchers will use swabs to collect skin samples. Photographs will be taken of the~          skin sample area.~        -  Some participants without leg ulcers also will have their skin microbiome sampled.~        -  Some participants who have their skin microbiome sampled will return for a second~          visit. At this visit, their microbiome will be resampled. It will take place more than~          30 days after the first visit.~   "
68855|NCT02156089|"~     Background:~      - People with attention-deficit hyperactivity disorder (ADHD) often have problems with~     motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children.~     Researchers want to learn more about the brain activity of people with ADHD and see how~     taking omega-3 fats might help.~      Objective:~      - To learn more about how omega-3 fats affect brain activity and ADHD symptoms.~      Eligibility:~      - Adults age 18 55 with ADHD symptoms.~      Design:~        -  Participants will be screened with medical history and review of medical records.~        -  For study visit 1, participants will have a medical examination and be interviewed to~          confirm they have ADHD. They will have an IQ test and give blood and urine samples.~          Height, weight, and blood pressure will be measured. They will also need to sign~          consent to agree to take part in the study. They will be asked to complete a food diary~          for 4 days~        -  For visit 2, participants will give a blood sample. They will complete questionnaires~          about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic~          testing.~        -  Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a~          table that slides in and out of a metal cylinder. It makes loud noises; participants~          will get earplugs. This scan examines the structure of the brain.~        -  Participants will have a functional MRI scan. This scan measures the function of the~          brain while the volunteer is performing tasks in the scanner. They will stop ADHD~          medications 48 hours before this scan.~        -  Participants will receive key-lime flavored omega-3 smoothie mix or placebo to~          takeevery day~        -  For visit 3, participants will give blood samples and complete questionnaires.~        -  For visit 4, participants will be weighed and have a blood test and MRI scans as per~          before. They will repeat the questionnaires and will guess whether they received the~          omega-3 or placebo.~   "
70766|NCT02131077|"~     The objective of this study is to evaluate the safety and efficacy of allogeneic~     adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.~   "
68856|NCT02156076|"~     The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation~     (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with~     paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg~     QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,~     respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will~     reduce AF burden as compared to baseline relative to placebo.~   "
68857|NCT02156063|"~     This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous~     NT100 in pregnant women with a history of unexplained recurrent pregnancy loss.~     Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.~   "
68858|NCT02156050|"~     Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the~     potential toxicity of bilirubin, newborn infants must be monitored to identify those who~     might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or~     kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants~     during the first week after birth. However, in some babies the amount of bilirubin pigment~     can increase to dangerous levels and require treatment. Treatment of jaundice in newborn~     infants is done by placing them under phototherapy, a process of exposing their skin to~     light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as~     light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type~     of light source which is power efficient, has a longer life and is portable with low heat~     production. Several technologies and devices are developed around this LED and specially a~     compact system.~      The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with~     conventional phototherapy (non-LED) and satisfaction of the parents and the professional~     staff about comfort of this new technology. The newborn infant is placed in a sleeper with~     the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the~     blue light. This one is generated by the module LED and transmitted in the braid of optical~     fibers which takes place directly on the mattress of the cradle in which is placed the~     patient usually.~      The device is endowed with an hour counter to schedule the time of treatment. The energy~     illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².~   "
68859|NCT02156037|"~     To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's~     use of a diabetes dashboard with a usual diabetes team care condition (UDC) that does not~     have access to the diabetes dashboard.~   "
68860|NCT02156024|"~     The purpose of this study is~        1. To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of~          masked hypertensive patients below 70 years.~        2. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.~   "
68861|NCT02156011|"~     The objective of this research is to synchronously assess in vivo loading data of the knee~     joint, tibio-femoral 3D kinematics by means of automated video-fluoroscopy, whole leg~     kinematics by means of skin markers, ground reaction forces, as well as muscle activity~     patterns in 4 to 6 subjects with instrumented total knee arthroplasty (TKA) during dynamic~     functional activities of daily life. The comprehensive in vivo dataset will provide unique~     information to evaluate the relationship between the kinematics, respectively the alignment~     of the TKA, and the resulting loading of the implant in vivo.~      The whole data package will be made available for download on a public database, such that~     it can be utilized for the testing and improvement of TKA designs as well as for the~     validation and improvement of musculoskeletal modelling by researchers around the world.~   "
68862|NCT02155998|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative medical institutions in order to get the information on administration of~     postoperative and post-radiation adjuvant androgen deprivation therapy (including go / no~     go decision, regimens, dosages and duration) used in locally advanced prostate cancer~     patients with high and very high risk of recurrence in Russia.~   "
68863|NCT02155985|"~     Since people started taking HIV medications, illness from AIDS has decreased, but other~     serious diseases like heart disease, cancer, and kidney, and liver disease have increased.~     HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured~     by blood. Inflammation can lead to diseases that have become some of the leading causes of~     death in people with HIV. HIV therapy can partially lower levels of inflammation measured in~     blood, however, levels of inflammation in people who have HIV may remain high compared with~     people not infected with HIV.~      Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and~     Drug Administration (FDA) for preventing heart attacks and stroke in those who are at~     increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the~     FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is~     thought to decrease risk of heart attack and stroke because it blocks the activation of~     platelets and prevents blood clots from clogging narrowed blood vessels, a disease called~     atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in~     some people at higher risk, but aspirin has been shown to modulate (or change) the immune~     system. In HIV-infected people who have been taking antiretroviral therapy and have an~     undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby~     aspirin), given for one week, lowers platelet activation and reduces blood markers of~     inflammation which may improve the function of the immune system.~      The purpose of this study was to evaluate whether aspirin improves inflammation and immune~     activation when compared to a placebo (inactive medication like a dummy pill) and to~     determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons~     on antiretroviral therapy. Additionally, it studied whether a higher dose and longer~     duration of aspirin provides further anti-inflammatory and immune-modulating benefit. This~     was done using blood and urine tests that measure inflammation and also with a test that~     uses ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation~     (FMD) of the brachial artery (BART). This is a painless test that bounces sound waves off of~     a blood vessel in your arm.~   "
68864|NCT02155972|"~     This is an 8-week randomized, double-blind placebo-controlled proof of concept study~     assessing the combination of a mood stabilizer + Align in the treatment of participants with~     a bipolar depressive episode. The study has two treatment arms: mood stabilizer plus placebo~     and mood stabilizer plus Align.~      The dose of mood stabilizer will be in accordance with clinical practice guidelines and the~     dose for Align will be 1 capsule per day as per appropriate product dosing.~   "
68874|NCT02155842|"~     The purpose of this study is to determine whether endurance exercise of either high or~     moderate intensity can reverse structural and functional changes of the heart in patients~     with diastolic heart failure, and to investigate which type of exercise is best in terms of~     aerobe capacity and quality of life.~      The investigators expect that high intensity endurance exercise is superior to moderate~     intensity endurance exercise.~   "
68875|NCT02155829|"~     The purpose of this study is to determine whether Riluzole is effective in the augmentation~     treatment of post-traumatic stress disorder (PTSD) that is experienced by Active Duty~     military service members and Operation Enduring Freedom (OEF), Operation Iraqi Freedom~     (OIF), and Operation New Dawn (OND) veterans who have not had symptom reduction after one or~     more kinds of medications or therapies.~   "
68865|NCT02155959|"~     Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis~     Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective~     single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl~     Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study~     patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the~     IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating~     Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in~     the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic~     acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery~     retroillumination photographs were taken to assess the rotational stability of the IOL.~     Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance~     corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss~     Meditec AG, Germany) measurements were performed at the 3 months follow-up.~   "
68866|NCT02155946|"~     The aging US population threatens to overwhelm our healthcare infrastructure, especially~     since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming~     decades. Memory cause functional impairment, reduced quality of life, increased caregiver~     burnout, and eventual institutionalization. The diagnosis of mild cognitive impairment (MCI)~     identifies those with memory deficits but who remain relatively independent in everyday~     life. MCI provides a window for interventions that target memory functioning. The proposed~     study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and~     non-invasive brain stimulation. The main idea is that brain stimulation can enhance~     functioning in the specific brain regions/networks, thereby increasing the patients' ability~     to benefit from different types of memory rehabilitation. This will be a randomized,~     double-blind study (active vs. fake brain stimulation), that provides multiple treatment~     session. Outcome will be examined using both laboratory-based and real-world memory testing~     as well as brain imaging. This first-of-its-kind study has the potential to meaningfully~     translate more basic science findings into neuroanatomically targeted and functionally~     meaningful treatments for our aging population.~   "
68867|NCT02155933|"~     Hormones are substances that are made by the body and are sent directly out into the~     bloodstream to increase or decrease the function of certain organs, glands, or other~     hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too~     much testosterone in their blood. Too much testosterone in the blood can possibly lead to a~     problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual~     periods, excess facial and body hair, and too much testosterone in their blood. On the other~     hand, some girls with too much testosterone in their blood do not develop PCOS. We do not~     know why some of these girls develop PCOS and why some do not. The purpose of this research~     study is to find out whether too much testosterone can cause problems with other hormones~     that can lead to the development of PCOS. This study may help us understand more about the~     causes of PCOS.~   "
68868|NCT02155920|"~     The purpose of this study is to evaluate the anti-tumor activity of Everolimus among~     children with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is~     incurable and has very limited treatment options. The rationale for this study is based upon~     both pre-clinical and clinical considerations: Immunohistochemistry studies have~     demonstrated that 20 out of 23 (87%) pediatric ependymomas are immunoreactive for~     phosphorylated S6, a biomarker that often predicts response to mTOR pathway-targeted~     therapy. Furthermore, children with with multiply recurrent ependymomas have had objective~     and durable responses to the mTOR inhibitor, Sirolimus (Rapamune, Pfizer). As a result of~     this pre-clinical and clinical data, this study will further investigate the activity of an~     mTOR pathway inhibitor, Everolimus, against children with recurrent or progressive~     ependymomas. In this study, Everolimus will be administered at a dose and schedule that have~     previously been demonstrated as safe and effective in children. Children may take Everolimus~     for up to 2 years on this study, until tumor progression or unacceptable toxicity.~   "
68869|NCT02155907|"~     Purpose~        1. To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording~          (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a~          consecutive population of patients with stroke or transient ischemic attack (TIA).~        2. To determine whether short run of atrial fibrillation (< 30s ) or the presence of many~          supraventricular extrasystoles detected on Holter recording, is associated with risk of~          re-stroke in a consecutive population of patients with stroke or TIA .~        3. To test whether a 7-day Loop Recording (R -test) detects more patients with atrial~          fibrillation than 2 days of Holter recording in a consecutive population of patients~          with stroke or TIA.~   "
68870|NCT02155894|"~     The study aims to investigate the effect a systematic telemedicine intervention, based on~     the tigth control principals, as a platform for disease monitoring among patients with~     rheumatoid arthritis.~      It is hypothesized that:~        -  A systematic telemedicine intervention targeted to tight control of disease activity~          among patients with RA will be equally effective as usual care (outpatient consultation~          by a rheumatologist).~        -  There will be no difference in the effect whether this telemedicine consultation is~          carried out by a rheumatologist or a rheumatology nurse.~        -  Patient satisfaction and the patient's general perception of involvement in their~          treatment will be increased for patients who receive the telemedicine intervention.~        -  All the effects will apply both in the short term (< 6 months) and in the long term (>~          1 year).~   "
68871|NCT02155881|"~     The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray~     200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in~     Russian participants.~   "
68872|NCT02155868|"~     Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality~     used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared~     spectroscopy has increasingly been used in perioperative setting of heart surgery and many~     studies have outlined an increased incidence of postoperative morbidity in patients with~     significant perioperative reductions in rSO2. Although a relationship between rSO2~     reductions and adverse outcomes has been reported, there is not compelling evidence that~     interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.~      Hypothesis of the study is that interventions to normalize intraoperatively decreased~     cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk~     cardiac surgery patients.~   "
68878|NCT02155790|"~     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device~     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving~     the kidneys. The catheter is typically inserted via the femoral artery, steered into the~     renal artery, and then delivers, by infusion from its distal end, a neurolytic agent. This~     targets the nerve bundles, which are in the adventitia - a sheath surrounding the artery.~     The aim is to reduce blood pressure in cases of resistant hypertension - seriously elevated~     blood pressure which does not respond to drug treatment.~   "
68879|NCT02155777|"~     Use of oral contraceptives (OCs) reduces a woman's risk of ovarian cancer very significantly~     and the protective effect continues for at least 25 years after use of OCs is stopped; the~     mechanisms of how this occurs are not understood. We are proposing here to directly study~     the effect of OCs on the fallopian tube and inclusion cysts within the ovary - sites from~     which most ovarian cancers are thought to arise - in order to better understand the~     mechanistic basis for OC protection against ovarian cancer. We think the protection results~     from reduced cell proliferation. It will lay the foundation for further studies to ensure~     that the protection against ovarian cancer afforded by 'traditional' OCs is not lost with~     alterations in OC formulation, and, if possible, to guide development of OC formations to~     improve further on the protection afforded by OCs.~   "
68880|NCT02155764|"~     Return to normal life and shortening rehabilitation period of patients after surgical~     removal of teeth is important and urgent social problem. In this regard, higher demands for~     quality of care and treatment of patients, which requires the development of new approaches~     to the treatment of patients, the introduction of new technologies and the associated~     development of new materials . Serious problem of contemporary oral and maxillo-facial~     surgery and dentistry is augmentation of bone defects generated during the surgical~     treatment of diseases and injuries of the bones. The results of surgical repair of bone~     defects are more dependent on the course of the process of reparative osteogenesis.~     Long-term periods of clinical studies indicate that reparative osteogenesis in posttraumatic~     bone defects is slow - months and years, and in some cases no bone defects filled with bone~     tissue.~      This project aims at addressing the preservation of bone volume in humans after tooth~     extraction using biomaterials with optimum performance. The practical significance of the~     project is to establish an effective tissue response and, thus, possible subsequent quality~     installation of dental implants. The proposed solution is based on the scientific~     development of the operative techniques, and a comparative analysis of several classes of~     biomaterials (xenogenic and synthetic analogs), including the use of biological precursors~     of bone apatite mineralization having osteoinductive (stimulating) properties.~   "
68881|NCT02155751|"~     This is a pilot project in which investigators will recruit obese (pre-pregnancy BMI of ≥ 35~     kg/m2) women from the newly developed My Clinic at London Health Sciences Centre as well~     as normal obstetrical care at London Health Sciences Centre.~      Patients will be randomized to one of three treatment groups: 1) the full Nutrition and~     Exercise Lifestyle Intervention Program (NELIP), 2) Nutrition program only, or 3) Exercise~     program only.~      The investigators hypothesize that the evidence-based NELIP for obese pregnant women will be~     feasible to adopt in a clinical setting and will prevent excessive gestational weight gain,~     gestational diabetes and promote healthy infant growth patterns at the 6 and 12 month~     milestones. Outcomes may be improved in My Clinic over normal obstetrical care patients with~     interprofessional services.~   "
68882|NCT02155738|"~     The purpose of this study is to determine whether preoperative IV Acetaminophen reduces~     postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic~     organ prolapse.~   "
68883|NCT02155725|"~     The purpose of the study is to assess the benefits of a therapeutic strategy that associates~     an early administration of human fibrinogen concentrate in the management of PPH on the~     reduction of bleeding after the initiation of prostaglandins intravenous infusion, following~     vaginal delivery.~   "
68884|NCT02155712|"~     The success rate of the Triathlon Tritanium Knee, defined as absence of revision for aseptic~     loosening of the tibial baseplate at 2 years, is no worse than rates reported in the~     literature for cemented devices.~   "
68885|NCT02155699|"~     The goal of this proposal is to test the feasibility and effectiveness of cardiovascular~     exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that~     are not there, feeling emotionally detached from self and others), cognitive difficulties~     (troubles with memory and learning), and every day social-occupational functioning in youth~     at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding~     how exercise may protect or improve the health of a brain area that is implicated as a major~     contributing factor to the onset of psychosis may lead to a path-breaking new intervention~     that does not suffer from many of the side effects, costs, and other barriers that~     characterize treatments that are currently available for this group. Because a significant~     portion of high-risk youth go on to develop a psychotic disorder in a short period,~     intervening at this stage may help to improve the clinical course and ultimately prevent the~     onset of a devastating and prevalent mental illness.~   "
68886|NCT02155686|"~     The elderly or people with disabilities want to remain in their homes even when their health~     condition has been getting worse.~      This project aims to demonstrate that home automation and telemonitoring can lead to develop~     a home safety environment that could help the elderly and individual with disability live~     independently in their own home.~      In this study, the automation sensors containing devices follow up chronic disease clinical~     factors to monitor their biometrical parameters and detect any abnormal prodromal disease~     decompensation via telemonitoring and geriatric expertise.~      The purpose of this study is:~        -  to provide clinical evidence of the effectiveness of automation tools and~          telemonitoring/expertise for the home support for people at risk of loss of autonomy~        -  to demonstrate the clinical benefit of combining the automation and telemonitoring and~          geriatric teleexpertise~   "
68887|NCT02155673|"~     The primary objective of this study is to determine the safety and tolerability of extended~     dosing of GCS-100 in patients with CKD.~   "
68888|NCT02155660|"~     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in~     symptomatic patients with moderate to very severe COPD who are receiving standard of care~     therapies.~   "
68889|NCT02155647|"~     This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the~     efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).~   "
68890|NCT02155634|"~     The purpose of this study is to see how long lenalidomide therapy can maintain or improve~     the disease response obtained after induction therapy that does not include lenalidomide,~     pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate~     the activity of lenalidomide. Patients will receive lenalidomide or be under observation.~     All patients will attend regular clinic visits to evaluate their disease and health.~     Patients will have the option to participate in additional biomarker correlative studies in~     addition to their participation in the main study.~   "
68891|NCT02155621|"~     The genomic heterogeneity of cancers implies that to effectively use targeted therapies the~     investigators will need to assess each individual cancer and match it to a biologically~     relevant targeted therapy. The investigators will use full genome sequencing to try to~     identify cancer drivers and corresponding drugs that may inhibit these pathways.~   "
68892|NCT02155608|"~     The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a~     potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).~      Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS~     treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG)~     profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side~     effect profiles.~   "
68893|NCT02155595|"~     The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone)~     fractures after long term fracture prevention therapy with a class of drugs called~     bisphosphonates, colloquially referred to as Alendronate, risedronate, Ibandronate, and~     Zoledronate.~      In addition, the study is designed to find out which patient is most likely to develop this~     potential life changing complication and why. Finally, the results of this study will help~     clinicians to better understand the reason and thus tailor patient specific treatments…i.e.,~     the right treatment for the right patient for right duration.~   "
68894|NCT02155582|"~     This study aims to analyze what the study drug does to the body and its relationship to drug~     levels and safety after patients with advanced cancer have been treated with copanlisib in~     different dose groups.~   "
68895|NCT02155569|"~     The aim of the study is to compare post operative morbidity between extra peritoneal~     cesarian and trans peritoneal cesarean section.~   "
68896|NCT02155556|"~     Aim of this study is to gain a better understanding of the diurnal changes of the cornea to~     improve toric IOL power calculations.~   "
68897|NCT02155543|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575~     in healthy subjects.~   "
68898|NCT02155530|"~     This study is a prospective randomized trial to evaluate and compare the quantitative and~     qualitative characteristics of neointimal formation between high and low efficacy statin~     treatment after drug eluting stent (DES) implantation, in patients with homogeneous or~     heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The~     investigators postulate that high efficacy statin could have superior effect on modification~     of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that~     Atorvastatin 40mg, high efficacy statin might have superior effect on modification of~     neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in~     patients with DES implantation.~   "
68899|NCT02155517|"~     Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more~     complete published until now. Schnider was derived from 24 healhty people, and including~     other covariates in addition to weight, such as age, height and lean body mass though.~     Schnider model should not be used in obese patients. Cortínez model was derived from 20~     obese patients. The differences between both models has been founded at the initial drug~     distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the~     plasma-effect equilibration time). We believe that Cortinez model also could be used in No~     OBESE patients because is an allometric model, and one way to evaluate and to compare both~     pharmacokinetics models is studying the temporary course of the effect.~      The main objective of our study is to evaluate BIS and Cardiac Output values during~     propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion~     in non obese healthy volunteer.~   "
68900|NCT02155504|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of single ascending oral doses of ASP3700 in healthy male subjects. This study will also~     explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to~     evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole~     in healthy male subjects.~   "
68901|NCT02155491|"~     The protocol is a large registry to describe acute, sub-acute and extended duration of~     anticoagulation management, clinical and economic duration of anticoagulation management,~     clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the~     real-world setting.~      Main objectives are to clarify the:~        -  treatment related details for acute VTE (either conventional anticoagulation therapy,~          treatment with a direct oral anti-coagulant or other modalities of treatment)~        -  Rate of early and late symptomatic VTE recurrence~        -  Rate and nature of complications of VTE including post thrombotic syndrome and chronic~          thromboembolic pulmonary hypertension~        -  Rate of bleeding complications~        -  Rate of all-cause mortality at six months~   "
68909|NCT02155374|"~     Objective: to determine which regimen results in best glycemic control and safety profile,~     expressed as glucose values within target range and occurrence of hypoglycemia. Secondary~     objective is to compare patient satisfaction, clinical outcomes and toxicity.~      Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years,~     who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of~     antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of~     chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent~     glucocorticoid and a wash-out period of 4-38 days between each cycle.~      Intervention: subjects will be treated by insulin regimen A and B in random order during two~     consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg~     prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin~     according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.~      Main study parameters: Difference in fraction of blood glucose measurements (BGM) within~     target range and occurrence of hypoglycemia.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both study treatments are just a slight variation in regular care for~     glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to~     treatments and increased counselling. All subjects will receive both treatment regimens.~      The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1~     venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3~     months before start), and 1 randomization visit to the outpatient clinic. Potential risk is~     the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators~     account for this risk by giving subjects dietary advice and education how to prevent,~     recognize and treat hypoglycemia.~   "
68902|NCT02155478|"~     The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular~     material in the anterior chamber of the eye as well as in other tissues of the body. Approx.~     70 million worldwide have a PXF syndrome.~      After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens~     more frequently than in the general population due to a higher incidence of zonular weakness~     and an increased capsular fibrotic reaction.~      Decentration, tilt and / or rotation of the lens can reduce the quality of vision.~      It is believed that the design of the implanted IOL, more precisely the front surface of the~     IOL has an influence on the extent of capsular fibrosis and contraction. Especially in~     presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the~     design of the IOL has an effect on the post-operative stability.~      In this study, two different IOL models are compared in terms of their stability. The~     Tecnis 1-piece ZCB00 (AMO, USA), with a concave lowering comprising the lens edge and the~     Acrysof SA60AT (Alcon, USA), with a biconvex design are compared. Forty eyes of 20~     patients are planned to be included in this study. One eye receives the Tecnis ZCB00~     1-piece (AMO, USA), while the other eye receives theAcrysof SA60AT (Alcon, USA).~      In which eye which IOL is implanted, is assigned by randomization. To measure the~     decentration, tilt and rotation of the IOL an examination will be performed before the~     operation and there will be follow-ups one hour after the operation of the first eye, one~     hour after the operation of the second eye, three months and twelve months after the~     operation on the second eye. All measurements will be done without touching the eye.~   "
68903|NCT02155465|"~     This is a phase 2 study. The goal of this study is to find out what effects, good and/or~     bad, taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and~     ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib~     together has not been studied before and is not FDA-approved.~   "
68904|NCT02155452|"~     The investigators aim to study the heterogeneity of fluorescence within malignant gliomas by~     sampling tissues from these variable areas within the same tumor. These tissue samples will~     then be subjected to pathological and biological analysis to assess proteins related to ALA~     metabolism and correlated with the fluorescence emitted as well as levels of protoporphyrin~     IX in the tissues.~   "
68905|NCT02155439|"~     The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in~     keloid disease treatment.~   "
68906|NCT02155426|"~     TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change~     of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy~      BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in~     oncology, and some studies have been conducted with success on breast and prostate cancer.~     Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC~     identification and monitoring these cells after treatment could help the clinicians to~     detect relapse or be a prognostic factor.~      PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of~     treatment (Overall response rate and Progression-free survival).~      SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.~      STUDY DESIGN : This is a prospective, observational study.~      Duration of the inclusions: 12months.~      SAMPLE SIZE : 1200 patients~   "
68907|NCT02155413|"~     Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other~     countries. With accumulation of experience and clinical evidence, APS has been well~     established. A study conducted in 1997 suggested that monitoring, management protocol and~     nursing experience were mandatory to the safety for APS. Our recent study showed that pain~     relief of our post-operative patients using patient controlled analgesic with morphine was~     still not adequate. The results has driven us to continue the improvement of post-operative~     outcomes for our surgical patients. Tolerability and safety are always our concerns for~     patients using our APS. Therefore, the investigators aim to conduct this retrospective study~     in order to assess if the tolerability and safety of our present APS are adequate or not.~     The study results will help us to further improve our APS at QMH if necessary.~   "
68908|NCT02155387|"~     The use of cardiopulmonary bypass (CPB) combined with one lung ventilation (OLV) allows to~     perform minimally invasive cardiac surgery (MICS) through small incisions. MICS is described~     to be associated with similar outcomes compared with conventional surgery. Although less~     invasive, MICS has not been reported to favorably impact the incidence of respiratory~     failure after surgery.~      The combination CPB and OLV may induce acute respiratory distress syndrome (ARDS). After CPB~     contact of blood components with the artificial surface of the bypass, lung ischemia~     reperfusion injury (LIRI) and operative trauma may trigger a systemic inflammatory response~     syndrome (SIRS). During OLV, ARDS can result from hyperoxia, hyperperfusion and ventilatory~     distress in the ventilated lung as well as from LIRI and operative trauma of the collapsed~     lung.~      Extravascular lung water (EVLW) includes all fluids in the lung except for those in the~     vascular compartment. An excess of EVLW may lead to respiratory insufficiency. This may be~     due to an increased hydrostatic intravascular pressure, as it occurs in cardiogenic~     pulmonary edema, and/or by an increase of lung endothelial and epithelial permeability, as~     in ARDS. The extravascular lung water index (EVLWI) assessed by the transpulmonary~     thermodilution technique may be a useful tool for accurate diagnosis of ARDS, and the~     pulmonary vascular permeability index (PVPI) may help in the differentiation between~     pulmonary edema due to an increase in the pulmonary capillary permeability versus an~     increase in the pulmonary capillary hydrostatic pressure.~      As both CPB and OLV may induce an excess of EVLW, the investigators hypothesize that~     patients after MICS with intraoperative combination of CPB and OLV may have higher EVLWI and~     PVPI than those who received either CPB or OLV alone.~   "
68910|NCT02155361|"~     This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in~     treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind~     placebo-controlled clinical trial design. This study includes 60 patients from SUMS~     endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as~     radiculopathies will be excluded. After giving the Informed consent the patients will be~     underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They~     will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic~     Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief)~     questionnaire and electrodiagnostic criteria will be evaluated.~   "
68911|NCT02155348|"~     More and more patients like to achieve complete spectacle independence after cataract~     surgery. Two possibilities that are particularly often used today are on the one hand~     multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is~     adjusted for closeness and the other focuses for distance). The drawback with multifocal~     lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision~     is that some patients lose a little of their stereo vision.~      The aim of this study is a direct comparison of these two methods. Therefore 70 patients are~     included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a~     near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1~     week and 3 months after surgery, patients are invited and tests for visual accuity are~     performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm).~     Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional~     measurements for detecting the tilt of the lens will be performed.~   "
68912|NCT02155335|"~     This study is designed to determine whether ulcerative colitis participants prefer delivery~     of golimumab via a prefilled syringe or the Smartject™ device.~   "
68913|NCT02155322|"~     This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant~     treatment for melanoma.~   "
68914|NCT02155309|"~     Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval~     Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time~     to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the~     efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.~   "
68915|NCT02155296|"~     The Restorative Practices Intervention (RPI), is a whole school environment intervention~     which is integrated into existing school practice (rather than 'added on') so does not~     compete with academic priorities; and it has some evidence supporting its effectiveness at~     improving school environment and promoting positive peer relationships. The specific aims of~     this investigator initiated study are to:~        1. Assess the mechanisms of how RPI implementation influences the school environment;~        2. Assess the effects of RPI on school staff perceptions of school climate and~          adolescents' reports of school connectedness, peer relationships, developmental~          outcomes (academic achievement and social competency) and problem behaviors (alcohol~          use, bullying, disciplinary referrals);~        3. Assess the extent to which the positive effects of RPI on adolescents persist over time~          during the transition between middle and high school.~      For the first time utilizing rigorous scientific methods, this study has the potential to~     document whether a whole-school intervention like RPI, that can be integrated into existing~     school practice, can affect both developmental outcomes and problem behaviors and whether~     the effects persist during the transition from middle to high school.~   "
68916|NCT02155283|"~     The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive~     motion home-use device in relieving low back pain, improving proprioception (balance and~     fall prevention) and improving the symmetry of muscle function on either side of the spine.~   "
68917|NCT02155270|"~     We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and~     surgically induced astigmatism as compared to a stab-incision (a corneal incision without a~     pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.~      Postoperatively, OCT scans will be obtained, corneal curvature will be measured and~     subjective and objective refraction will be performed in order to measure the~     surgically-induced astigmatism.~   "
68918|NCT02155257|"~     The purpose of this research study is to test whether or not researchers can alter or change~     expectations on pain. The researchers will test whether there is an effect on the size of~     the pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the~     knee or hip or healthy subjects for comparison.~      One of 3 possible treatment groups will be administered to qualifying subjects: (1)~     gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a~     medication that is commonly used to treat people with narcolepsy (a disorder that causes~     people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill,~     that is not thought to have any effect on your disease or condition~   "
68919|NCT02155244|"~     In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified~     after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this~     study is to determine leaving the gallbladder in situ does not reduce the morbidity rate~     after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.~   "
68920|NCT02155231|"~     OBJECTIVES~        1. To determine the prevalence and incidence of anal HPV infection, including infection~          with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.~        2. To study the prevalence and incidence of HGAIN among these MSM.~        3. To evaluate risk factors, including HIV status, for anal high-risk HPV infection and~          HGAIN among these MSM.~      Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the~     study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also~     enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT~     study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in~     this study.~   "
68938|NCT02154997|"~     During pregnancy nutrition demands change and the pregnant woman needs to adjust her food~     intake and take into consideration the corrected daily recommendations for micro and macro~     nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food~     choice.~      Amongst pregnant women with Diabetes the glucose balance is extremely important during~     pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin.~     This delicate balance requires from the pregnant women an ability to perform correct~     carbohydrate count.~      Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes.~     Hypoglycemia may also have a negative effect but the main danger is immediate harm to the~     mother and therefore to the fetus. For those reasons glucose balance is crucial and demands~     delicate synchronization of nutrition and insulin therapy.~   "
68983|NCT02154412|"~     This clinical study is designed to investigate the mechanisms of blood pressure regulation~     and respiratory motor function affected by spinal cord injury (SCI). We hypothesize that~     impaired blood pressure regulation in individuals with chronic SCI can be improved by~     restoring respiratory motor function by using Respiratory Motor Training (RMT).~   "
68921|NCT02155218|"~     In Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) a contrast agent is injected~     into an arm vein using a programmable medical device called a power injector. Once the~     contrast has circulated to the blood vessel of interest they can be imaged with MRI and~     distinctly separated from surrounding non-vascular tissue.~      This project is designed to find the best way to administer the contrast agent during CE-MRA~     to produce the best images. The clinical availability of programmable power injectors~     facilitates the use of variable contrast rate and volume injection protocols that are based~     on patient specific parameters.~      CE-MRA is a valuable imaging tool for diagnosing abnormalities of the major blood vessels in~     the chest and abdomen. It is often used in conjunction with cardiac magnetic resonance (CMR)~     examinations to evaluate the blood vessels of the heart and lung. CE-MRA is attractive~     because 1) it does not involve radiation, and 2) the contrast agents used are not toxic to~     the kidneys and can be used in patients who are at greater risk for kidney dysfunction~     following iodinated contrast agents.~      We plan to administer a small (1cc) test amount of contrast, taking pictures as the contrast~     passes through the blood vessels, and analyze the results. Using this information, we will~     administer an individually patient-tailored injection given in multiple phases (i.e., a~     multi-phasic injection) to maintain constant contrast concentration (and therefore~     constant signal intensity) throughout the scan. We believe this will reduce image blurring,~     and improve the sharpness and likely the diagnostic quality of CE-MRA.~   "
68922|NCT02155205|"~     The purpose of this study is to demonstrate that telotristat etiprate does not differ from~     placebo in the mean change from Baseline QT interval corrected for heart rate.~   "
68923|NCT02155192|"~     The purpose of this study is to evaluate the association between genetic factors and~     response to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis~     (scaly skin rash).~   "
68924|NCT02155179|"~     The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest~     implantation potential. In order to identify the factors that may affect the rate of embryo~     cleavage, there are many studies about morphokinetics and culture medium, oxygen tension,~     oocyte quality or type of medication used for ovarian stimulation. However there are no~     published data with respect to the influence of semen quality in the embryo kinetic.~      In this study The investigators propose that the sperm quality may has influence in the~     embryo division.~   "
68925|NCT02155166|"~     This study has the objective to evaluate the effect of Injectable intracervical anesthesia~     in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores~     immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in~     women without previous vaginal delivery.~      H0: There is no difference in terms of pain score between the treatments H1: There will be~     difference in terms of pain score between treatments~   "
68926|NCT02155153|"~     Postoperative ileus is generally referred to as the transient impairment of bowel motility~     after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting~     constipation and distension.~      The potential complications of prolonged POI include increased postoperative pain, increased~     nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral~     intake, delay in postoperative mobilization, prolonged hospitalization, and increased~     health-care costs. The estimated economic impact of POI in the United States is $7.5 billion~     per year, excluding the expenses of work loss.~      In view of these complications and economic burden a number of pharmacologic and~     non-pharmacologic strategies have been adopted by the doctors all over the world to reduce~     the burden of postoperative ileus.These programs involve transverse or curved surgical~     incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and~     postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.~      The use of gum chewing has emerged as a new and simple modality for decreasing POI. And~     reviews have concluded that there is consistent benefit for patients from gum chewing after~     the intestinal surgery; colonic surgery and gynecological surgery.~      This study is based on the hypothesis that postoperative gum chewing is beneficial in~     prevention of postoperative ileus after reversal of ileostomy.~   "
68927|NCT02155140|"~     Patients due to undergo surgery for oesophageal and gastric malignancy are often~     malnourished. Up to 10% of patients preoperative weight may also be lost during the early~     postoperative period. Following discharge from hospital the mechanics of the surgery leads~     to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and~     gastro-oesophageal reflux which usually results in reduced dietary intake and further weight~     loss. In patients who have undergone upper gastrointestinal resections there are no studies~     examining the benefit of nutritional supplementation following hospital discharge, however,~     studies in other groups of surgical patients have failed to show benefit. Despite patients~     who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no~     evidence demonstrating the value or not of nutritional supplementation following hospital~     discharge.~      Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will~     exacerbate the reduced quality of life and fatigue patients' already experience. The~     investigators hypothesise that improving patient's nutritional intake following hospital~     discharge will improve their quality of life and fatigue levels.~   "
68928|NCT02155127|"~     Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the~     U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million~     individuals. Impairments in physical function and mobility limitations have been reported in~     older Chronic Kidney Disease patients, however the consequences of impaired functioning on~     participation in daily life and quality of life have not been studied. Early identification~     and interventions to mitigate deterioration in physical function and mobility should lead to~     improved health and quality of life outcomes in older patients with Chronic Kidney Disease.~     Although older individuals with Chronic Kidney Disease have reduced survival expectancy,~     maintaining physical function and mobility may contribute to longer active life expectancy,~     and higher quality of life despite their diagnosis.~   "
68929|NCT02155114|"~     The purpose of this study is to survey iron storage levels and their prognostic consequences~     in the context of acute inflammation. The impact of iron substitution in inflammatory states~     is controversial. We hypothesize that iron substitution may influence outcome in patients in~     inflammatory states.~   "
68930|NCT02155101|"~     The aim of this pilot study is to assess the feasibility, efficacy and safety of~     Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance~     strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon.~     HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2~     nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir~     (LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA (viral) load~     testing. Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test~     ideally 4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50~     cps/ml the patient will be invited to join the randomised phase of the study. Patients~     (n=150) will be randomised 1:2 to either continue the current triple ART regimen (n=50) or~     switch to DRV/r monotherapy (n=100). The primary end-point will be viral load suppression~     <400 cps/ml at week 24; secondary end-points will be viral load suppression <50 cps/ml at~     week 12 and week 24, safety, tolerability, and emergence of protease inhibitor (PI)~     drug-resistance. Patients will continue observational follow-up depending on the treatment~     arm they are randomized to. After week 48, patients will return to local standard of care.~     Pharmacokinetics (PK) and pharmacogenomics sub-study to correlate plasma concentrations of~     DRV to outcomes, HIV-1 drug resistance testing sub study to detect mutants archived at the~     time of first-line ART failure and measuring HIV DNA load will be performed, as well as a~     cost-effectiveness analysis will test the hypothesis that savings can be achieved by~     switching to DRV/r monotherapy without affecting quality of care. The primary virological~     objective is to evaluate efficacy in terms of the percentage of subjects who have plasma~     HIV-1 RNA levels <400 cps/ml after 24 weeks of follow-up following a switch to DRV/r~     monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA~     Snapshot method).~      Study hypothesis:~      we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe~     treatment option for patients receiving second-line ART in Yaoundé.~   "
68931|NCT02155088|"~     The main purpose of this study is to see primarily if BYL719 is safe to be given to patients~     in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an~     FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the~     effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In~     the first part of the study, different doses of BYL719 will be tested. In the second part of~     the study, all patients will be started at the same dose of BYL719.~   "
68932|NCT02155075|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging~     technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology~     generates 3D metabolic maps of the breast and based on sophisticated machine learning~     technology, provides objective risk assessment for the presence of malignant tumor in the~     breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation.~     It is based on acquiring infrared images of the breast. Those images are processed and~     analyzed by computers to provide the objective risk assessment.~      The technology is intended to be used as a screening tool for breast cancer and emerges as~     highly useful in women for whom screening mammography is sub-optimal, such as women with~     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating~     patients with mammographically dense breasts.~      Another group of women for whom screening mammography is sub-optimal are women with breast~     implants. There is reason to believe that 3D MIRA technology can be applied successfully for~     breast cancer screening in women with implants.~      The purpose of this clinical study is to assess the ability of this novel technology to~     detect breast cancer in augmented women.~      The investigators hypothesize that the presence of breast implants will not affect the~     ability of this new technology to correctly classify healthy women and breast cancer~     patients.~   "
68933|NCT02155062|"~     Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye~     grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in~     measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are~     absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable~     biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting~     this proposal. Different AR species are present in characteristic quantities in WG wheat in~     comparison to WG rye cereals, which can allow identification of the main source of WG (wheat~     or rye) in individuals by analysing the AR concentrations in blood. However the patterns of~     urinary AR metabolite excretion following wheat or rye intake have not yet been investigated~     to determine if there are differences according to WG source.~      The present study aims to:~      (i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine~     samples after following a predominantly WG rye-based diet in comparison to a predominantly~     WG wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the~     validity and reproducibility of AR metabolites in spot urine samples in comparison to 24~     hour urine samples.~   "
68934|NCT02155049|"~     Prostaglandin analogues eye drops are common and effective treatment for decreasing~     Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case~     reports have documented periorbital fat atrophy following treatment by prostaglandin~     analogues. In this study the investigators want to use this side-effect of prostaglandin~     analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid~     eye disease (TED) patients, as a conservative substitute for surgical intervention.~   "
68935|NCT02155036|"~     The proposed research aims to examine whether regular aerobic exercise can preserve renal~     function, improve aerobic capacity, physical and psychosocial function, strength,~     cardiovascular function, general well-being and quality of life. Ultimately, the research~     aims to prove that exercise is a more cost-effective and a more efficient use or healthcare~     resources used in the treatment of patients with CKD. Exercise is a relatively cheap~     treatment option which is readily available and accessible for this patient population.~     establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;~        1. Preserves renal function.~        2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular~          function, general well-being and quality of life.~   "
68936|NCT02155023|"~     Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM,~     Germany)) will be investigated to determine the optimal calibration method in patients with~     type 1 diabetes~   "
68937|NCT02155010|"~     Patients were randomized into two groups, A group and B group. A group and B group patients~     are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy~     bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine,~     respectively.~      The investigators will compare of hemodynamics and patient's comfortability between two~     groups.~   "
68949|NCT02154854|"~     The purpose of this study is to compare parallel-group effects between 4 months and 12~     months post-transplantation 2 values of target residual concentrations of Advagraf on~     vascular parameters in de novo renal transplant patients.~   "
84351|NCT01953302|"~     Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate~     efficacy of modified technique of ventral hernias repair: an open intraperitoneal mesh~     technique.~   "
68939|NCT02154984|"~     The purpose of this study is to study the relationships between obesity, hormones and~     menopausal status, and breast cancer. The researchers would like to study whether a type of~     nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a~     smartphone application; the researchers also want to study the effect that a tRD has on~     weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to~     restrict their daily eating to a specific time frame each day. The researchers think that~     this might be an effective and manageable way to control weight.~   "
68940|NCT02154971|"~     The ageing process is known to be accelerated in HIV-infected patients, compared to the~     general population.~      Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than~     70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial~     damage caused by oxidative stress.~      Risk factors for accelerated age-related hearing loss are present in many HIV-infected~     patients : chronic inflammation, smoking, diabetes, etc.~      The global aim is to measure the prevalence of presbyacusia in a well controlled HIV~     positive population in France, and to compare it to HIV negative controls matched for age~     and sex.~      90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a~     screening for presbyacusia (pure-tone, speech and evoked-response audiometry).~      We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as~     compared to controls matched for age and sex.~   "
68941|NCT02154958|"~     300 women with unexplained infertility who are already decided to be treated with ICSI will~     be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.~      On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed~     and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC~     will be defined as the number of follicles measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by (Human menopausal~     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)~     administration. On the day of HCG administration, ovarian ultrasound scan will be performed~     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)~     is defined as number of follicles measuring≥16mm. FORT will be calculated as: (PFC) *~     100/AFC.~   "
68942|NCT02154945|"~     Purpose:~      Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness~     changes during pregnancy by Optical coherence tomography~      Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in~     participants who develop systemic or ocular complications during the study period.~   "
68943|NCT02154932|"~     Introduction: The study aimed to investigate the effectiveness of a single versus double~     dose of Prostaglandin E2 Misoprostol, 400 microgram during myomectomy for multiple uterine~     fibroids. This was a prospective randomized controlled trial comprised of 69 patients with~     multiple myomas undergoing myomectomy. Patients randomly allocated to either an~     intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34~     cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra~     and post-operative blood loss, hemoglobin concentration, blood pressure and body's~     temperature were estimated and compared in both groups.~   "
68944|NCT02154919|"~     To compare the different effect of conservative pharmacotherapy and Staged Percutaneous~     Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment~     elevation myocardial infarction (STEMI) at presentation remains controversial~   "
68945|NCT02154906|"~     Inflammatory periodontal disease often results in loss of bone around the teeth. Bone~     defects that have a certain size and shape (called intrabony or intraosseous defects) may be~     improved by using a graft material in the bony defect. The purpose of this study is to~     compare healing of periodontal intrabony defects that are treated using demineralized freeze~     dried bone allograft (DFDBA) versus autogenous platelet-rich fibrin.~      The null hypotheses is that there will be no significant differences in bone fill, CAL gain,~     PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.~   "
68946|NCT02154893|"~     There are several therapeutic effects of the ultrasound (US) or low level laser therapy~     (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory~     response and accelerated tissue repair. The investigators hypothesis was that a combination~     of US, LLLT and therapeutic exercise may maximize clinical outcome.~   "
68947|NCT02154880|"~     Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.~      The study is a multicenter, prospective observational study of aging and pulmonary function~     in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction~     as quantified by pulmonary function testing in both younger (<50 years) and older (≥50~     years) HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and~     enrich enrollment for individuals over the age of 50 while adjusting for important~     co-variates such as ART, smoking history, co-infections, and illicit drug use. Evaluations~     will be scheduled at baseline, 18 months, and 36 months. Study visits will consist of blood~     draw, questionnaires, and pulmonary function testing.~   "
68948|NCT02154867|"~     Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded~     Placebo Controlled Trial - the REFIT project~      Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like~     diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of~     life and increased sickness absence. The prevalence of IBS in the general population may be~     as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS~     is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other~     less well founded theories have been stated. So far, no measurement or test can affirm~     diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern~     according to the Rome classification can set the diagnosis.~      Earlier non-controlled case reports have shown a convincing effect of fecal microbial~     transplantation (FMT) in IBS patients. However, no placebo controlled trial has been~     performed in this condition. Changes in the gut microbiome may be an important factor in IBS~     pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may~     trigger changes in visceral sensibility and pain perception.~      The fecal microbial transplantation (FMT) procedure has been used primarily to treat~     clostridium difficile infections. Few minor side effects have been reported.~      Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by~     transplanting a microbiome sample from a healthy donor.~      Aim of study:~        -  To test the clinical effect of FMT in patients with IBS~        -  To describe the fecal microbiome in IBS patients~        -  To describe changes in the fecal microbiome of IBS patients following FMT~      The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on~     IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients~     will recruited from general practice and allocated to active (30) or placebo (30) by block~     randomization. Donors will be 15 healthy volunteers with no risk behaviour and a~     pre-screening for communicable diseases will be performed.~      Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0,~     1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing~     (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.~   "
68950|NCT02154841|"~     It is well known that patients who have undergone major surgical procedures are vulnerable~     to the consequences of inadequate calorie or nutritional intake. Clinical studies have~     demonstrated that early post-operative feeding increases strength and healing of an~     intestinal anastomosis, reduces surgical site infection and length of hospital stay. The~     'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its~     key goals, however there is no guidance on the type of food that should be offered to~     patients in this programme. Anecdotally, many patients and healthcare professionals believe~     that there are differences in how food tastes to early post-operative patients. If there are~     changes in taste following surgery this will affect the food choices that patients make in~     the early post-operative period. No studies have addressed this question to date. In this~     study we hope to describe this affect and consider the significance of any changes on the~     background of current hospital food options.~      We hypothesise that food preference and tastes and desires are altered in the early post~     operative period and this affects what patients eat at this critical time.~   "
68951|NCT02154828|"~     The research project is part of the evaluation of the therapeutic approaches in mental~     health. Its framework infant and juvenile units that have developed integrative devices,~     taking into account recent advances in knowledge and providing care, education and~     pedagogical approach. The evolution of autistic children receiving these integrative devices~     is studied to determine the validity of the devices mentioned. The methodology is based on~     case studies in a natural situation. Clinicians are committed to network among themselves~     and with researchers in a multicenter study.~   "
68952|NCT02154815|"~     The main objective is to assess the psychological impact of pre-emptive kidney~     transplantation on patients' quality of life taking into account psychological adjustment~     (response shift), compared to patients who have experienced a short pre-transplant dialysis~     period of less than 36 months.~   "
68953|NCT02154802|"~     Because people with undiagnosed HIV will not receive treatment and may unknowingly infect~     others, the investigators propose a mobile computer-based video intervention to increase HIV~     test rates in high volume urban hospital emergency departments (EDs). EDs offer important~     points of contact for many of those at greatest risk for HIV. Unfortunately, when ED~     patients are offered routine HIV testing, most decline. Our proposed intervention builds~     upon initial findings from a trial our research team conducted with patients who declined~     HIV testing. The intervention, grounded in the Information-Motivation and Behavioral Skills~     model (IMB), showed an onscreen physician explaining the importance of HIV testing (to build~     knowledge and motivation) and modeling a rapid HIV test (to increase motivation and~     behavioral skill). This brief intervention had a potent effect: a third accepted HIV testing~     post-intervention. While this preliminary study is highly encouraging, it revealed a number~     of other critical research questions. First, it remains unclear what intervention component~     most strongly contributed to patients' decisions to test: the video content or the offer of~     an HIV test by a computer rather than a person. Second, consistent with the literature,~     participants indicated a community member disclosing positive HIV status onscreen would~     increase the proportion of patients who test. Third, results suggest there is individual~     variation in the extent to which behavior is more strongly influenced by onscreen community~     members or experts (e.g. physicians). Therefore, the goal of the present study, guided by~     the IMB model, is to determine how the investigators can refine mobile computer-based~     interventions to maximize HIV testing rates among patients who initially decline to test in~     the ED. At the end of the computerized intervention, onscreen text will ask patients if they~     would agree to an HIV test. Those who agree will be tested by ED staff. The study's endpoint~     will be post-intervention HIV test rates. The investigators' study will inform scalable~     interventions for underserved populations nationwide.~   "
68954|NCT02154789|"~     Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint,~     usually the last joint of the finger or toe, often due to underlying joint arthritis. They~     may connect with the joint. Pressure from the cyst can result in deformity of the digit's~     nail and trauma to the cyst results in leakage of the fluid, representing a potential source~     of entry for infection. Cysts can be tender and interfere with the digit's function. A~     variety of treatments are available, from simple extrusion which is rarely successful, to~     more destructive cryotherapy, infra-red coagulation and formal excision under local~     anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant~     injection of polidocanol in one small non-randomised trial has been reported to be a well~     tolerated efficacious treatment with minimal scarring and long-term resolution. Following a~     pilot study, the investigators aim to trial this treatment to assess efficacy in a larger~     population.~   "
68955|NCT02154776|"~     This is a multi-center, open-label, non-randomized, phase I study~   "
68956|NCT02154763|"~     This is a pilot study in a randomized, controlled, double-blinded format and will evaluate~     the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass~     surgery. The drug will be administered into the abdomen during a bariatric bypass surgery.~     After surgery, patients who received Ropivacaine will be compared to those without~     Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to~     walk, and quality of life during recovery.~   "
68957|NCT02154750|"~     This is a randomized, prospective clinical trial to determine the effects of two different~     pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual~     chamber pacemakers implanted for symptomatic bradycardia with long PR intervals (delayed~     conduction between upper and lower chambers of the heart). The study will compare a long,~     fixed AV delay (standard) with an optimized AV delay for each individual using~     echocardiography (experimental).~   "
68958|NCT02154737|"~     The purpose of this study is to see whether an altered schedule of giving erlotinib in~     combination with gemcitabine will be safe and might improve the results of the treatment for~     advanced cancer of the pancreas.~      Gemcitabine and erlotinib are commercially available. Gemcitabine is FDA approved as~     first-line treatment for patients with locally advanced, unresectable or metastatic cancer~     of the pancreas. Erlotinib is FDA approved in combination with gemcitabine for the~     first-line treatment of patients with locally advanced, unresectable or metastatic~     pancreatic cancer.~      The FDA recommended dose for erlotinib is 100 mg daily. This study will investigate the~     experimental administration of higher doses of erlotinib given for only three days twice a~     month, a schedule called pulse dosing.~   "
68959|NCT02154724|"~     Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain~     stimulation (DBS) strategy could achieve an even better clinical result by adapting to~     patient's condition. As intracerebral activity analyzed by recording local field potentials~     (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an~     intelligent adaptive DBS system able to change stimulation settings automatically to the~     patient's needs using LFPs as control variable.~   "
70984|NCT02128230|"~     The purpose of this study is to improve the clinical outcomes of research subjects with~     high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial~     2008-02 and Total therapy 3 trials 2003-33 and 2006-66.~   "
68960|NCT02154711|"~     The purpose of the study is to use a new research imaging technique, a kind of magnetic~     resonance imaging (MRI), to measure important metabolic features of muscle, including~     mitochondrial function, in people with mitochondrial disease and in healthy individuals.~     (Mitochondria are tiny organelles that generate energy for the body.)~      It is hoped that this new strategy will help physicians to understand better the health~     problems of people with mitochondrial disease. Eventually, this could lead to better~     diagnostic and treatment approaches.~   "
68961|NCT02154698|"~     The purpose of this study is to compare the usefulness of two needles (used for obtaining a~     lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial~     ultrasound~   "
68962|NCT02154685|"~     Smoking occurs in approximately 21% of the US population, is responsible for an annual~     mortality rate of approximately 438,000 citizens, and has an associated healthcare economic~     burden of $167 billion. Although pharmacotherapies have improved cessation outcome, the vast~     majority of individuals making quit attempts relapse within 5-10 days of cessation. The~     hypotheses to be examined in this study may have potentially important implications for~     smoking cessation treatment and will, therefore, target the single greatest~     addiction-related cause of morbidity and mortality.This study will investigate a novel~     behavioral strategy for altering important memory processes that underlie human~     smoking-related nicotine addiction. This strategy used in this study employs established cue~     exposure procedures to putatively update smoking-related memory with information that will~     suppress responding to smoking cues. The goal here is to alter existing nicotine-related~     memory directly rather than rely exclusively on the establishment of an inhibitory~     extinction process, via traditional cue exposure therapy, which is known to be vulnerable to~     spontaneous recovery, renewal and reinstatement. Positive findings would represent a~     significant advance in exposure-based therapy for addiction and could lead to a treatment~     that uniquely targets the problem of cue-elicited craving and reactivity, thereby addressing~     a major obstacle to successful smoking cessation.~   "
68963|NCT02154672|"~     The purpose of this study is to determine the incidence of prostate cancer in men with the~     BRCa2 gene mutation as an independent indicator for prostate cancer screening.~   "
68964|NCT02154659|"~     Gastroesophageal reflux disease is increasing worldwide. The causes of reflux symptoms are~     not found exactly. especially, the postprandial reflux symptoms are more common than the all~     day reflux symptoms. One of the causes of reflux symptoms is the relaxation of the lower~     sphincter of the esophagus. But, the sphincter relaxation also occur in normal people. But,~     there is a difference in postprandial reflux pattens between the patients and the normal~     people. So, in this study, we want to compare the difference of reflux pattern between the~     patients who have postprandial reflux symptoms and normal people though the 24hr pH~     monitoring.~   "
68965|NCT02154646|"~     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in~     combination with gemcitabine in Japanese participants with pancreatic cancer that is~     advanced or has spread to another part of the body.~   "
68966|NCT02154633|"~     Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer~     syndrome. Genetic testing identifies mutation carriers and enables them to manage their~     cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance).~     However, uptake of genetic testing among at-risk individuals is low, implying that~     information about the disease and genetic testing is not being communicated effectively~     among family members. Mutation carriers are distressed about disclosing test results, while~     their relatives do not understand the implications of a positive test result for their own~     health. Thus, interventions that support family communication about genetic risk, and~     address psychological distress of family members could contribute to more effective~     management of hereditary breast/ovarian cancer.~      The project aims to develop a family communication and decision-support intervention to 1)~     increase family communication about BRCA1/2 mutations; 2) reduce psychological distress~     associated with these mutations; and 3) increase informed decision-making regarding uptake~     of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and~     at-risk relatives will inform the refinement of the intervention, as well as timing and mode~     of delivery. Two group, pre-post test study with a new sample of mutation carriers and~     family members will be used to test the feasibility, acceptability, and effect of the~     intervention.~   "
68967|NCT02154620|"~     Distal radius fractures with dorsal dislocation among patients 70 years or older are~     randomized to conservative treatment with plaster or internal fixation with a volar plate.~     Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray,~     functional scores and clinical examination.~   "
68968|NCT02154607|"~     Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally~     presenting a management challenge to the clinician. In addition it can have debilitating~     consequences on the patients' quality of life. The malignant transformation of OLP has been~     well documented. The aims of this work were to measure the number of patients developing~     malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients~     undergoing traditional symptomatic treatments with those patients that were treated by CO2~     laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).~   "
68969|NCT02154594|"~     To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in~     patients with fixed orthodontic appliances.This study is a double blind randomized~     controlled trial.~   "
68970|NCT02154581|"~     In this study a tooth that needs to be extracted will be replaced by an implant (artificial~     root) placed at the same appointment as the extraction. The investigators want to observe~     how the gums change shape with healing in two different scenarios:~        1. If the soft tissue around your tooth is thin, following extraction and implant~          placement an extra soft tissue graft (taken from your palate) in the area in order to~          increase the thickness of your gums after healing.~        2. If the soft tissue around your tooth is thick, the implant will be placed without a~          soft tissue graft.~      Previous studies have shown that both methods work and can give good results. In fact the~     two methods are used routinely but they have never been compared objectively to one another~     in the same research study.~      The main purpose of this study is to evaluate if there is any difference in terms of~     esthetic outcomes between these two treatment modalities after a crown has been placed on~     the implant.~   "
68972|NCT02154555|"~     Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33~     million Americans. The treatment of CRS typically begins with maximal medical therapy~     however, when this fails to improve patient symptoms, surgical intervention is considered.~     Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with~     approximately 600,000 sinus surgeries performed annually in the United States alone. Despite~     the success of this intervention, up to 26% of patients experience complications following~     surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle~     turbinate lateralization. Currently, there is no consensus as to the postoperative care~     regime that is most effective at minimizing or preventing these potential complications.~     Therefore there is need for further study into the role of debridement, examining patients~     undergoing endoscopic sinus surgery while concurrently addressing the potential confounders~     of maximal medical therapies in the postoperative setting.~      This prospective, randomized, single-blind, controlled study design will investigate the~     efficacy of postoperative debridement following ESS. Patients who have undergone ESS will~     have one nare randomized to debridement and the other to no debridement at the first week~     post-operative visit. In this way, the patients will act as their own controls in order to~     account for inter-patient variability in disease severity. The primary outcome will assess~     synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific)~     attributed to the debridement procedure as well as comparing pre and post endoscopy scores~     and SNOT-22 questionnaire responses.~   "
68973|NCT02154542|"~     Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive~     care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial~     pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the~     duration of ventilation, mortality, length of ICU stay and health costs. The practitioner~     should ask the benefit of the continuation of this IV daily and adapting it, to limit~     complications. The evaluation of the work of breathing is a key element in understanding the~     pathophysiology of respiratory distress but is also a key element in improving the~     management of ventilatory support and the adjustment of ventilatory parameters .~      It has been shown that there is an increased work of breathing in all children admitted in~     ICU for clinical acute respiratory distress that is significantly reduced by ventilatory~     support. There is probably a relationship that should be proportional between the work of~     breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and~     the electrical activity of the diaphragm ( Edi ) .~      The validation of this correlation PTP / Edi has a direct impact on the monitoring of~     ventilated patients with the ability to monitor the physiological factor while maintaining a~     classical treatment of children by simply monitoring Edi without additional invasive device~     .~   "
68974|NCT02154529|"~     Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the~     combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast~     cancer~   "
68975|NCT02154516|"~     The purpose of this study is to assess the early safety and efficacy of a new hard-on-hard~     total hip replacement system in patients with non-inflammatory arthritis.~   "
68976|NCT02154503|"~     Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which~     has been limited with few options for medical and surgical treatment, the cost of the latter~     being prohibitive for many. Recently there have been several new modalities proposed as~     treatment, namely Microneedling and Platelet Rich Plasma.~      Microneedling has been shown to overexpress hair growth factors which may enhance or~     stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of~     topical products significantly. The exact mechanism of action of Microneedling is still~     being delineated.~      In this study, we aim to do a half lesional study with global photographs and hair counts~     done at the start of , week four and week twelve. Patients would be needled once weekly~     after application of topical anaesthetic (5% EMLA). If by week six there is significant~     regrowth (>30%), then total lesional needling will be done. Patients will only be using~     topical 5% Minoxidil throughout the study as this will prolong the effects of the regrowth.~   "
68977|NCT02154490|"~     This screening and multi-sub-study randomized phase II/III trial will establish a method for~     genomic screening of similar large cancer populations followed by assigning and accruing~     simultaneously to a multi-sub-study hybrid Master Protocol (S1400). The type of cancer~     trait (biomarker) will determine to which sub-study, within this protocol, a participant~     will be assigned to compare new targeted cancer therapy, designed to block the growth and~     spread of cancer, or combinations to standard of care therapy with the ultimate goal of~     being able to approve new targeted therapies in this setting. In addition, the protocol~     includes a non-match sub-study which will include all screened patients not eligible for~     any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to~     standard of care also with the goal of approval.~   "
68978|NCT02154477|"~     Over the last few years, studies have shown that men with type 2 diabetes sometimes develop~     a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce~     little or no sex hormones. Obesity and metabolic syndrome are also associated with HH.~     Research suggests that insulin in the brain may benefit the glands that release these~     hormones. During this study, subjects will spray a small amount of insulin into their~     nose.This will increase insulin concentrations in the brain. The purpose of this study is to~     find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in~     obese diabetic men with HH.~   "
68979|NCT02154464|"~     The investigators predict that giving patients paracetamol in the operative period will~     reduce their need for opioid pain reducers in the post operative setting.~   "
68980|NCT02154451|"~     The hypothesis or study goal is to determine whether functional dynamic infrared imaging can~     be used for melanoma and other skin cancer screening and/or diagnosis.~   "
68981|NCT02154438|"~     The purpose of this study is to evaluate the effect of ketamine infusion for reduction of~     neuropathic pain and improvement of quality of life after lumbar surgery.~   "
68982|NCT02154425|"~     The primary objectives of this study are to assess whether there is transfer of Certolizumab~     Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing~     regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to~     calculate the daily infant dose of maternal CZP.~   "
68985|NCT02154386|"~     Bone grafting following tooth extraction is commonly performed to preserve bony ridge~     dimensions adequate to support subsequent implant placement. Alveolar ridge resorption~     commonly occurs following tooth extraction, and the decrease in bone volume has the~     potential to make dental implant therapy impossible without surgery to reconstruct the~     ridge. The aim of ridge preservation grafting is to prevent or minimize this resorptive~     process, thereby preserving an adequate volume of bone for implant placement. Ridge~     preservation generally involves placement of a particulate bone graft material in the tooth~     socket, followed by use of a membrane or similar substance over the socket entrance to~     contain the bone graft. Various grafting materials have been recommended for these ridge~     preservation procedures, including demineralized freeze-dried bone allograft (DFDBA). The~     timing of dental implant placement following ridge preservation procedures is controversial,~     and few studies have examined the effects of different healing time intervals between ridge~     preservation and implant placement. The purpose of this project is to evaluate the formation~     of new bone at a site where tooth extraction has been performed followed by grafting using~     DFDBA. Two different study groups are included, one having the dental implant placed 8-10~     weeks after tooth extraction and ridge grafting, the other having the dental implant placed~     18-20 weeks after extraction and grafting.~   "
68986|NCT02154360|"~     This is an open-label, single arm, phase I study to determine the safety, PK characteristics~     and anti-inflammatory effects of the NK-R1 coadministered with ritonavir-containing~     antiretroviral therapy in individuals with well-controlled viral replication.~      Our hypothesis is that Aprepitant will be safe, well tolerated, and will have~     anti-inflammatory properties when administered concomitantly with the protease inhibitor~     ritonavir.~   "
68987|NCT02154347|"~     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as~     combination therapy with insulin in patients with type 2 Diabetes Mellitus who show~     inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral~     hypoglycemic agent.~   "
68988|NCT02154334|"~     The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms~     affecting the nose) and co-administration of mometasone or oxymetazoline on the~     pharmacokinetics (explores what the body does to the drug), safety, and tolerability of~     intranasal (administered through the nose) esketamine.~   "
68989|NCT02154321|"~     The purpose of this research is to assess and determine brain oscillations or brain~     signatures of adult participants with Attention Deficit Hyperactivity Disorder (ADHD)~     relative to adult participants without ADHD using the technique electroencephalogram (EEG).~     Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal~     of this study is to establish biological factors for determining the diagnosis of Attention~     Deficit Hyperactivity Disorder (ADHD).~   "
68990|NCT02154308|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG~     Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.)~     administered as a single intramuscular injection.~   "
68991|NCT02154295|"~     The purpose of this study is to investigate and compare the images obtained from coronary~     imaging catheters used in the treatment of coronary blockages both in a clinical setting~     with patients and in models.~   "
68992|NCT02154282|"~     To see if using ipod games can improve mental functioning~   "
68993|NCT02154269|"~     The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in~     patients with chronic heart failure secondary to Chagas disease.~   "
68994|NCT02154256|"~     This study will be a three-arm randomized, controlled trial that the investigators will run~     in 2014 with approximately 4,000 users of an app called Achievemint. AchieveMint rewards~     users with points (which can be redeemed for prizes) for every step they take. The~     investigators will be testing three different point-based programs designed to encourage~     users to build exercise habits over the course of a month: stable incentives, increasing~     incentives, and decreasing incentives. After the investigators' month-long intervention~     period, the investigators will observe users' step counts during a month-long follow-up~     period to test which of the investigators' habit-building programs leaves users with the~     best exercise habits (or the highest step counts) after they conclude.~      The time frame of observation will be 8 months.~   "
68995|NCT02154243|"~     Orthostatic hypotension following total hip arthroplasty is known to limit the ability of~     patients to perform physical therapy (PT) and increase the length of hospital stay and~     costs. Our goal is to prospectively study the effects of oral midodrine on the signs and~     symptoms of orthostatic hypotension in 20 patients and the effects of intravenous fluid on~     the signs of symptoms of orthostatic hypotension in 10 patients. Midodrine will be~     administered to patients with suspected low SVV, and an intravenous fluid bolus will be~     administered to patients with low CO. 120 patients will be consented with a view to studying~     30 patients who meet the inclusion criteria for orthostatic hypotension. Patients who~     receive midodrine or the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr,~     2 hrs, 3 hrs, and 4 hrs post-intervention. All patients will undergo measurements for blood~     pressure, arterial augmentation index, and heart rate at baseline (pre-op; holding area) and~     the time of first PT attempt. Patients will be monitored up to post-operative day 3. The~     working hypothesis is that midodrine or fluid therapy will significantly raise the mean~     arterial blood pressure (MAP) by 5 mmHg+ and/or cause a significant change in the~     Orthostatic Hypotension Questionnaire (characterized by a two-point improvement in symptom~     score).~   "
68996|NCT02154230|"~     Overweight and obese patients will be recruited and randomly assigned to two groups of~     intervention. To the first group [sulphate-bicarbonate-calcium water and low-calorie diet~     (SW-D)] will be administered Acqua Santa di Chianciano®, associated to a personalized low~     calorie diet, while the second group [tap water and low-calorie diet (TW-D)] will follow the~     personalized low calorie diet but will be asked to drink the same quantity of tap water,~     over a 4 week period. Stool samples will be collected and analyzed for changes in gut~     microbiota composition. Patients' body weight will be recorded at the beginning and at the~     end of the study.~   "
68997|NCT02154217|"~     This is a data revision with a focus on 24 hour perfusion pressures of data from a previous~     randomized, double masked, multicenter clinical trial.~      The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost~     and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched~     from a nonfixed combination of latanoprost and timolol.~      The main findings of the original trial had been published on Ophthalmology [2007;114:~     2244-2251].~   "
68998|NCT02154204|"~     The aim of this study is to examine the use of Near Infrared Fluorescence imaging on~     lymphatic vessels in humans.~      Different parameters that reflect lymphatic function will be tested for intra and inter~     individual reproducibility.~      We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy~     men between the ages of 20 and 30.~      When the fluorescent dye indocyanine green, has been injected into the skin on the~     patients feet, it will be transported through the lymph vessels, resulting in clear~     visualization of the vessels, using a laser and a EM-CCD camera.~      On both legs we examine the frequency of vessel contraction and the velocity of lymph moving~     in vessels. We furthermore use several methods to quantify the vessel function such as the~     refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and~     pumping pressure (at what pressure lymph can pass a blood pressure cuff).~      We investigate the activity of vessels over time, and after several interventions such as~     exercise, and water baths of the foot at different temperatures.~      The patients are examined for approximately 4 hours and wil be examined again 14 days later.~   "
68999|NCT02154191|"~     The purpose of the proposed research is to explore the relationship between objectively~     measured physical activity and surgical intervention for lumbar spinal stenosis (LSS). Our~     primary hypothesis is that post-surgery, LSS patients will demonstrate increased physical~     activity compared to their baseline assessment. A non-intervention control group will be~     measured at the same time intervals as the surgical group to look at test re-test~     reliability. In the event that our hypothesis is rejected, and surgery does not lead to a~     decrease in sedentary behaviour analysis of questionnaire-based sedentary behaviour measures~     and objective activity-based measurement can examine the relationship between self-report~     and actual performance-based objective measures. The primary objective of our proposal is to~     determine if surgical intervention leads to increased activity, and decreased sedentary~     behaviour. The findings of the proposed research will inform healthcare stakeholders that if~     surgery alone does not lead to increased activity, a more concerted research effort may need~     to be made for post-surgical rehabilitation, lifestyle and physical activity counselling so~     that post-surgical patients may make changes toward leading more active and productive~     lives.~   "
69000|NCT02154178|"~     The investigators hypothesized that the use of biomarkers of invasive fungal infections~     would increase the percentage of early discontinuation of empirical antifungal therapy and~     thus reduce the duration of treatment in ICU patients.~   "
69001|NCT02154165|"~     The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by~     clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength~     about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden~     standard in phototherapy treatment today. Though, previous studies used light tubes, today~     we use light emitting diodes (LED'S).~      The overall aim of this study was therefore to compare the efficacy of turquoise LED's~     versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33~     weeks and uncomplicated hyperbilirubinemia.~   "
69002|NCT02154152|"~     Homeopathic Medicine Causticum 200c will be prescribed in cases of Primary Enuresis on the~     basis of available symptoms for a period of one year and the results will be evaluated at~     the end of the given period and efficacy of the drug will be assessed.~   "
69003|NCT02154139|"~     The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks)~     of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR~     11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice,~     as well as to examine factors that can influence the safety and efficacy of treatment with~     leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).~   "
69004|NCT02154126|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics~     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with~     reference standard measurements (YSI glucose analyzer). The investigation will also evaluate~     safety of the Senseonics CGM System usage, while in the clinic and during home use.~   "
69005|NCT02154113|"~     The purpose of this study is to compare the clinical performance of the Ultrashape system~     with VelaShape II device for reduction of the waist.~   "
69006|NCT02154100|"~     The hypothesis of this study is that the daily consumption of 480 ml tart cherry juice for~     twelve weeks will improve blood pressure and arterial stiffness by improving~     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering~     biochemical markers associated with cardiovascular risk. 28 men and women between the ages~     of 20 and 40 who have three of the five features of metabolic syndrome as defined by the~     Adult Treatment Panel III will be included in the study. After a two-week run-in phase,~     eligible men and women will be randomly assigned to one of two treatment groups: 1) 480 ml~     tart cherry juice or 2) 480 ml control drink daily for twelve weeks. After an initial~     telephone screening, all participants will be requested to report to the study site for~     their first visit. On the first visit (screening), participants will be provided with verbal~     and written explanation of the project. They will then be asked to sign an informed consent~     form, followed by measuring waist circumference, resting brachial blood pressure, fasting~     serum triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm~     metabolic syndrome. Baseline assessments will be performed for medical history, medication~     use, dietary intake, and physical activity. Qualified participants will be scheduled for~     their second visit two weeks later (actual baseline data collection) and randomly assigned~     to their treatment group. On the second (baseline) visit between the hours of 7-10 A.M.,~     blood pressure and vascular function will be measured followed by blood draw.~     Anthropometrics will be measured. Participants will be provided with their assigned~     treatment and will receive standard instructions on how to fill out daily diaries for their~     treatment, and for food and physical activity records. Blood pressure, vascular function,~     blood draw, and anthropometric, body composition, diet, and physical activity assessments~     will be repeated at 6- (third visit), and 12-week (final visit) intervals. All~     cardiovascular measurements will be performed between 7:00 to 10:00 A.M., in a quiet~     temperature-controlled room in the supine position after an overnight fast and 12 hours~     after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy~     physical activity.~   "
69007|NCT02154087|"~     Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in~     chronic venous leg ulcers~   "
69008|NCT02154074|"~     Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the~     activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the~     operation period. Dexmedetomidine have influence on perioperative stress response and immune~     function,but it is not clear.~   "
69052|NCT02153502|"~     The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability~     of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive~     disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A~     secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and~     potential correlations with pharmacodynamic effects.~   "
69009|NCT02154061|"~     The purpose of the study is to better understand how the use of antibiotics changes~     micro-organisms in the intestines. The change to micro-organisms in the intestines may~     change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal~     flu) vaccine.~      In particular, the investigators will be looking at certain markers in blood after~     vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before~     vaccination.~      There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days~     prior to vaccination and continue taking antibiotics the day of vaccination and one day~     after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu~     vaccine) and will not take any antibiotics.~      The investigators hope to enroll 50 subjects at Emory.~   "
69010|NCT02154048|"~     The purpose of this study is to determine whether the addition of dexamethasone prolongs~     analgesia when added to long-acting local anesthetic during single-injection supraclavicular~     block for outpatient hand surgery.~   "
69011|NCT02154035|"~     Background:~      Human Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood~     for many years, even in people who have their HIV infection under control. HIV that is~     hiding in the blood is called the latent HIV reservoir. Researchers want to find out more~     about it in this study. This knowledge may help them develop new ways to prevent or control~     HIV. This study will draw its participants from the Rakai Health Sciences Program in rural~     southwestern Uganda.~      Objective:~      - To measure and learn about the latent HIV reservoir in Ugandans with HIV.~      Eligibility:~      - Men and women at least 18 years of age with HIV.~      Design:~        -  Participants will have a medical history and physical exam. Their medical records will~          be reviewed. Researchers will ask participants about their health and recent illnesses.~          Participants able to get pregnant will have their urine tested for pregnancy.~        -  Participants will have their finger pricked to see if they have enough red blood cells~          to be eligible for the study.~        -  If eligible, participants will have blood drawn through a needle in the arm. Their~          blood will also be tested for other diseases.~        -  After the blood draw, participants will be asked to stay seated or lying down if they~          are not feeling well for up to 30 minutes.~   "
69012|NCT02154022|"~     Background:~      - Certain drugs even when they are meant to help people cause side effects. These are~     unwanted effects of the drug. There are many reasons why a drug might cause side effects in~     one person and not in another. It may be because of how much of the drug is in the person s~     blood at one time. Researchers want to study the blood of people having drug side effects to~     better understand why they happen.~      Objective:~      - To obtain blood samples from patients being treated with an investigational or FDA~     approved drug at the National Cancer Institute who are having bad side effects that are~     thought to be due to large amount of the drug in their blood. The samples will be used to~     assess the cause of the side effects.~      Eligibility:~      - People 2 years and older with cancer who are currently enrolled in clinical trials at the~     National Cancer Institute.~      Design:~      - Participants will give blood samples.~   "
69013|NCT02154009|"~     Background:~      - The autonomic nervous system helps control things that happen automatically in the body,~     like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called~     dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn~     how to better diagnose them.~      Objectives:~        -  To allow people with autonomic disorders to be evaluated.~        -  To help fellows in the NIH Autonomic Disorders fellowship program see a variety of~          diseases in their training.~      Eligibility:~        -  People age 18 and older with dysautonomia; children over age 2 if they might benefit~        -  Healthy adult volunteers~      Design:~        -  Participants will have different procedures depending on their symptoms. They will have~          one or more visits. They will have some but not all of the tests below.~        -  Participants will have a medical history and physical exam. They may be tested for~          problems thinking. They may complete a symptom questionnaire. They may have their~          temperature and blood pressure taken.~        -  Participants may have an intravenous line placed. A needle will guide a thin plastic~          tube into an arm vein.~        -  Participants may have blood drawn several times. They may give a urine sample.~        -  Participants may have an electrocardiogram.~        -  How much blood a participant s heart is pumping and/or how much blood is flowing~          through their arm may be measured. The total amount of blood in their bloodstream may~          be measured.~        -  Participants may have their ability to sweat and/or sense of smell tested.~        -  Breathing, bowel sounds, and/or body functions may be monitored.~        -  Pupil size, response to environmental temperature changes, and/or breathing may be~          measured.~        -  Participants may have a bladder ultrasound.~        -  Small pieces of skin may be taken for study.~   "
69014|NCT02153996|"~     Plasmodium falciparum malaria is a major cause of morbidity and mortality in tropical and~     sub-tropical areas worldwide. Repeated P. falciparum infections in endemic areas induce~     protective immunity, thus providing optimism that an effective malaria vaccine can be~     developed. Key to the development of such a vaccine is an understanding of the immune~     mechanisms underlying protection and the longevity of these responses in the absence of~     continuous P. falciparum exposure. Anecdotal evidence suggests clinical immunity to malaria~     wanes within months to years after an immune individual leaves an endemic area. A detailed,~     systematic description of the quality and longevity of the P. falciparum-specific humoral~     and cellular immune responses in such individuals over time in the absence of ongoing~     exposure is lacking.~      This protocol will attempt to fill this knowledge gap through comprehensive longitudinal~     immunological analyses of two populations of healthy adult volunteers: 1) naive travelers~     returning from malaria endemic areas recently treated (within 2 weeks) for acute P.~     falciparum malaria and referred from hospitals in the metropolitan Washington DC area; and~     2) immigrants from malaria endemic areas living in the metropolitan Washington DC area with~     serologic evidence of past P. falciparum exposure. In both groups, venipuncture and possibly~     apheresis will be performed for the isolation of plasma, RNA and peripheral blood~     mononuclear cells (PBMCs) which will be analysed to understand the components of innate and~     adaptive immunity to malaria. Na(SqrRoot) ve travelers returning from malaria endemic areas~     recently treated for acute malaria will undergo venipuncture at enrollment, then once every~     2 weeks for 2 months, then every 3 months for 1 year, and then every 6 months for up to 5~     years. Immigrants will be seen every three months for one year and then every six months for~     up to 5 years. All subjects who return to the U.S. from a malaria endemic area will be~     evaluated within two weeks of return for repeat venipuncture and will restart the same~     sequence of blood draws as naive travelers. Optional apheresis will be performed on both~     na(SqrRoot) ve travelers and immigrants at enrollment, at 1, 6, and 12 months, then yearly~     therafter.~      The primary objective is to estimate the quality and longevity of P. falciparum-specific~     humoral and cellular immune responses in the absence of ongoing P. falciparum exposure in~     both returned na(SqrRoot) ve travelers and immigrants. The secondary objective is to compare~     the P. falciparum-specific humoral and cellular immune response in na(SqrRoot) ve travelers~     and immigrants to individuals in malaria-endemic areas enrolled in ongoing LIG protocols in~     Mali.~   "
69015|NCT02153983|"~     Background:~      - Being overweight may cause low-level inflammation. This inflammation may cause some of the~     medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study~     will test whether a medication called colchicine can improve metabolism in adults who are~     overweight but have not yet developed diabetes.~      Objectives:~      - To learn whether colchicine improves sugar regulation and metabolism.~      Eligibility:~      - Healthy overweight adults at least 18to 100 years old.~      Design:~        -  Participants must fast before each visit, including the screening visit.~        -  Participants will be screened with blood tests,urine tests, medical history, and~          physical exam. They will have to drink sugar water, and have blood drawn to find out if~          they are healthy.~        -  For visit 1, participants will have a medical history and physical exam and answer~          questions. They will have blood taken with an intravenous (IV) line, give urine sample,~          and give 2 stool samples..~        -  Also, subjects will get sugar water through one IV. Blood will be drawn from the other.~          This measures sugar and insulin levels. During this, participants will lie in a bed and~          can watch TV.~        -  Participants will have a full-body X-ray, lying on a table while a camera passes over~          them. They will also have an abdominal CT scan, lying on a table that moves through a~          ring that takes pictures.~        -  Participants will have a small fat tissue sample taken from their abdomen. It is like~          getting a mini-liposuction.~        -  Participants will be given the study drug or placebo. They will take it twice daily for~          3 months.~        -  For visit 2, participants will have blood tests, urine tests, medical history, and~          physical exam.~        -  For visit 3, participants will repeat the tests in visit 1.~   "
69016|NCT02153970|"~     Background:~      - Neuromuscular diseases (NMDs) do not have cures. But future treatments will try to improve~     the health-related quality of life (HRQoL) in people with NMD. Computer questionnaires can~     help test HRQoL in people with NMD. They could help clinicians and researchers know how~     people with NMD and their caregivers are doing. They could also help show if treatments are~     making a difference.~      Researchers want to make sure two of these questionnaires PROMIS (Patient Reported Outcomes~     Measurement Information System) and Neuro-QOL (Quality of Life in Neurological Disorders)~     work the same way every time. They also want to make sure the questionnaires test the same~     things every time.~      Objective:~      - To make sure the PROMIS and Neuro-QOL questionnaires are valid.~      Eligibility:~      - Children age 8 17 who have NMD. Also, caregivers of children age 5 17 who have NMD.~      Design:~        -  Participants will complete the PROMIS and Neuro-QOL questionnaires on a computer. The~          caregiver and child versions are not the same.~        -  Participants will complete the questionnaires at the beginning of the study. It will~          take about 15 20 minutes. They will complete the questionnaires again after 2 4 weeks.~          They may receive phone or email reminders.~        -  Participants will complete the questionnaires at the NIH outpatient clinic and/or on~          their own device. At NIH, they will use a computer or tablet.~   "
69017|NCT02153957|"~     Background:~      - More children with cancer are surviving into adulthood. Some side effects from treatment~     go away quickly. But some problems may not go away or may only show up months or years~     later. These problems are called late effects. Late effects can cause difficulties in~     cognitive functions, such as attention and memory. Physical activity has been found to~     improve the attention and memory skills of children with Attention Deficit Hyperactivity~     Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive~     problems in children with brain tumors.~      Objectives:~      - To see if physical activity can improve cognitive functions in children who had radiation~     therapy for a brain tumor.~      Eligibility:~      - Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must~     have access to a computer.~      Design:~        -  Participants will be screened with height, weight, and medical history. They will~          answer questions about daily physical activities. Their heart will be checked.~        -  Participants will go to the clinic for 2 days. They will have a fitness exam and tests~          about attention, memory, and concentration. They will have blood taken and answer~          questions. Parents will also answer questions.~        -  Participants will be put into 2 groups. For the first 12 weeks, the intervention group~          will follow a physical activity program. The control group will do their usual physical~          activities.~        -  For the second 12 weeks, the control group will follow the physical activity program.~          The intervention group will continue the activities on their own. All groups will track~          their physical activity with an activity monitor and computer.~        -  Participants will have a follow-up visit at the clinic after each session. They will~          repeat some of the tests listed above.~        -  The study lasts 24 weeks plus the two follow-up visits. Participants can keep their~          activity monitor.~   "
69018|NCT02153944|"~     Background:~      Stress and anxiety can interfere with how well people perform tasks. But performing a task~     can sometimes lessen anxiety by distracting people from the stress. Researchers want to~     examine the interaction between attention and stress. They will use two drugs with different~     effects on stress and concentration.~      Objective:~      - To better understand how thinking and emotion affect anxiety and performance. Also, to~     study the effects of methylphenidate and propranolol on performance.~      Eligibility:~      - Adults age 18 50.~      Design:~        -  First, participants will be screened with a test in which they hear loud, sudden noises~          through headphones. Sticky pad electrodes will be placed on the skin under one eye.~          These electrodes will tell us how sensitive participants are to the noises.~        -  Second, participants will complete questionnaires about their mood, thinking, and~          anxiety. They will give a saliva sample. For this, a cotton swab will be placed in~          their mouth for 2 minutes.~        -  Third, participants will take a single dose of one of the study pills or a placebo.~          They will then look at words, shapes, and letters on a computer monitor. They will~          answer questions about what they remember. They may receive a shock or hear loud noises~          during the tests.~        -  For the shocks, small metal disk or sticky pad electrodes will be taped to a wrist or~          finger. For recording bodily responses, additional electrodes will be placed on the~          arms, body, and under each eye.~        -  Blood pressure and pulse will be measured during the tests. More saliva samples will be~          taken.~        -  At the end of the study, participants will answer questions about their reaction to the~          study testing and about any effects they noticed from the study pill.~        -  After the experiment, participants will be evaluated for effects of the study pill.~   "
69019|NCT02153931|"~     Background:~      - Studies show that Internet Support Groups (ISGs) can help parents of children with chronic~     conditions. Researchers want to find out if ISGs can help parents of a child with the~     genetic disorder Neurofibromatosis Type 1 (NF1).~      Objective:~      - To see if an ISG for parents with a child with NF1 can give the parents more social~     support and less anxiety.~      Eligibility:~      - Adults age 18 and older with a child (age 0 25 years) with NF1.~      Design:~        -  Participants will register for the study on a website hosted by the Children s Tumor~          Foundation.~        -  Participants will complete 5 questionnaires. These will be about their emotional~          well-being, their child s health status, and their contact information.~        -  The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7~          days a week. A professional moderator will post questions and discussion topics. The~          moderator can also respond to questions. They will be a psychologist, a psychology~          associate, or a nurse-practitioner. Each one will be highly experienced at working with~          young people with NF1 and their families.~        -  The ISG also will contain a chat room. Here participants can chat with other users in~          real time. The chat room will be open for one 90-minute session per week.~        -  The ISG will remain open for 8 weeks. Then participants will retake 4 of the~          questionnaires from the beginning of the study. They will also complete 1 other~          questionnaire about their experiences with the ISG. Information from any messages~          participants post on the ISG website will be collected.~        -  Three months after the ISG closes, participants will complete the questionnaires one~          final time.~   "
69020|NCT02153918|"~     Background:~      - Some men with prostate cancer have their prostate glands removed. The cancer can still~     come back. Researchers want to know if receiving a vaccine before prostate removal surgery~     can lead to less recurrence.~      Objective:~      - To see if a vaccine and booster shots given to men with prostate cancer before surgery~     changes the immune cells in the prostate gland.~      Eligibility:~      - Men age 18 and older who have prostate cancer that has not spread, and who want to have~     their prostate glands removed as treatment.~      Design:~        -  Participants will be screened by their regular cancer care. They may have a small piece~          of prostate removed.~        -  Participants must practice effective birth control before and during the study~          treatment and for 1 month after the last vaccine booster.~        -  Participants will have a medical history, physical exam, and blood and liver tests.~          They will be asked about how they perform daily activities.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The~          scanner is a metal cylinder in a strong magnetic field. Participants will lie on a~          table that slides in and out of the scanner.~        -  Participants will be injected with the vaccine, most likely in the leg. They will be~          injected with the vaccine booster 3 times over several weeks.~        -  At each booster visit, participants will have a medical history, physical exam, and~          blood and liver tests.~        -  Participants will have another MRI. Then they will have surgery to remove their~          prostate.~        -  Participants will have 2 follow-up visits during the year after surgery. They will have~          a medical history, physical exam, and blood test.~   "
69021|NCT02153905|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     cancer that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying these specific cells with a type of virus~     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.~     This type of therapy is called gene transfer. In this protocol, we are modifying the patient~     s white blood cells with a retrovirus that has the gene for anti-MAGE-A3 incorporated in the~     retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-MAGE A3 cells) cause tumors to shrink and to~     be certain the treatment is safe~      Eligibility:~      - Adults age 18-66 with cancer expressing the MAGE-A3 molecule.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti MAGE-A3 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti MAGE-A3 cells and aldesleukin. They will~          stay in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
69022|NCT02153892|"~     To assess the safety and performance of the GDS Accucinch System when used percutaneously to~     reduce functional mitral regurgitation.~   "
69023|NCT02153879|"~     The structural and functional alterations of high density lipoproteins (HDL) levels in type~     2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance,~     inflammation and oxidation, play a major role in the increased macrovascular risk in these~     patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL~     concentrations.~      Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by~     ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship~     between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of~     arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in~     Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the~     impact of HDL increasing drugs on HDL qualitative changes.~   "
69024|NCT02153866|"~     Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if~     the safety and immunogenicity are same between inoculating several vaccines simultaneously~     and inoculating individually. So we carry out this study.~      The purpose of this study is to evaluate the difference of safety and immunogenicity on~     vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or~     measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR~     individually.~   "
69025|NCT02153853|"~     Obesity is on the rise in the Western population and BMI has been shown to be associated~     with an increased risk of per- and postoperative complications.~      The investigators intend to study a population of more than 300 patients undergoing~     laparoscopic surgery for rectal cancer.~      The investigators main outcome measure will be the conversion rate, and the investigators~     also intend to study other indications of short term complications, such as peroperative~     bleeding, infection, re-operation and mortality.~      The investigators hypothesise that increased BMI does not increase the risk of conversion.~   "
69026|NCT02153840|"~     The purpose of this study is to evaluate the efficacy and safety of Chinese herbal~     PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of~     Chinese Medicine.~   "
69027|NCT02153827|"~     The purpose of this study is to examine the effects of eccentric exercise to the shoulder~     muscles for people with shoulder pain. Identifying specific exercise protocols for~     individuals with shoulder pain will provide evidence to help clinicians select the best~     interventions.~   "
69028|NCT02153814|"~     Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro~     fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with~     sperm to make embryos, which are then placed in the woman's uterus using a small catheter, a~     procedure called embryo transfer. Unfortunately, pregnancy rates from IVF are less than~     50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing~     the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks~     prior to embryo transfer. These studies were all performed outside the United States (U.S.)~     in women with multiple failed IVF attempts and did not investigate the mechanisms by which~     endometrial injury works. This study will be the first to evaluate the effect of endometrial~     injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo~     transfers, and donor eggs.~   "
69029|NCT02153801|"~     The aim of this study is to compare the incidence of genito-urinary function depression and~     anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal~     Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the~     Left Colic Artery by a prospective randomized trial.~   "
69030|NCT02153788|"~     The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and~     one of which is a placebo (an inactive substance that looks just like the temazepam), to see~     if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are~     given in research studies to try and make sure that subjects are responding to the effects~     of the study drug and not to other factors, like the attention they are receiving. If you~     decide to take part in this study, you will take 1 capsule of study drug every night~     approximately 30 minutes before bedtime for approximately 12 weeks.~      This study is to test the study drug called temazepam for the treatment of insomnia (trouble~     sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the~     treatment of insomnia. However, because this study requires treatment for 12 weeks instead~     of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be~     investigational in this study.~   "
69031|NCT02153775|"~     Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive~     Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.~   "
69053|NCT02153489|"~     The purpose of this study is to assess the effect of aclidinium bromide compared with~     placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic~     obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of~     treatment with aclidinium bromide 400 μg administered twice daily in patients with stable~     moderate-and-severe COPD.~   "
69054|NCT02153476|"~     Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human~     subjects with symptomatic focal vitreomacular adhesion~   "
69032|NCT02153762|"~     The purpose of this study is to evaluate the safety and tolerability, as well as~     effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic~     Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash.Topical~     skin barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added~     lipids (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to~     the the treatment of atopic dermatitis. BRTs are often used along with topical steroids~     (medicated creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single~     treatment) on both non-diseased and diseased skin. Since BRTs help to restore components of~     skin that are absent in skin with AD, it is believed that long-term BRT use may reduce~     further development of further AD. This is an open-label, single site study.~   "
69033|NCT02153749|"~     The investigators propose that brief training in regulation of craving may increase the~     efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based~     strategies may operate via different psychological and neural mechanisms.~   "
69034|NCT02153736|"~     The primary aims of this randomized controlled trial are to evaluate efficacy potential of~     SPEEDI at enhancing reaching and play based problem solving compared to infants receiving~     usual care.~   "
69035|NCT02153723|"~     A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading~     known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic~     name - Glatiramer acetate) is medication FDA approved for the treatment of multiple~     sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients~     for more than 12 years.~   "
69036|NCT02153710|"~     This is a behavioral speech therapy trial for individuals who have suffered a stroke on the~     left side of the brain and have difficulty speaking. The name of this disorder is called~     aphasia. Individuals in this study will receive one of two treatments. The first is a~     phonological (sound level) treatment and the second is a semantic (word level) treatment.~     Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5~     days/week, 6 weeks).~   "
69037|NCT02153697|"~     Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals.~     Their removal may be requested for aesthetic reasons.~      The goal of the study is comparing the efficacy and tolerance of two different therapy~     modalities established for treating solar lentigines.~      The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser,~     the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm®~     cream).~      The investigators estimate that a physical therapy with a Q-switched Rubin laser system is~     more effective in the removal of solar lentigines than a topical chemical therapy with a~     hydrochinon containing bleaching cream.~   "
69038|NCT02153684|"~     The Canadian Respiratory Research Network (CRRN) has recently been established to study the~     origins and evolution of airways disease in the population. The CRRN is funded by the~     Institute of Cardio-respiratory Health (ICRH), an institute of the CIHR. The Physiology~     platform will support the other CRRN platforms (biology, imaging, population health,~     knowledge transfer) by providing a comprehensive characterization of the nature and extent~     of physiological impairment of respiratory function in smokers at risk for airways disease~     and in those with early or mild airway obstruction. The planned studies of the physiology~     group (core sites located at Queen's University, University of British Columbia and McGill~     University) will initially focus on smoking-related lung injury in those at risk for COPD~     and in those meeting spirometric criteria for mild airway obstruction, with or without~     respiratory symptoms. The primary aim of this initial study is to identify and validate~     sensitive test(s) of peripheral airway dysfunction that may qualify as physiological~     biomarkers for use in future CRRN studies.~   "
69039|NCT02153671|"~     This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can~     induce a long-lasting immune memory by comparing the immunologic response to two doses of~     the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects~     who did not received LAIV.~   "
69040|NCT02153658|"~     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV~     prevention. The Government of Rwanda was the first country to implement the PrePex and acts~     as the leading Center of Excellence providing trainings and formal guidelines. As part of~     the Government's efforts to improve the PrePex implementation, it made efforts to improve~     the psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC~     in sub-Saharan Africa.~      Some men who gone through the PrePex procedure complained of foreskin odor while wearing the~     PrePex 3-7 days after it is placed. This complaint was identified as potential risk for the~     PrePex uptake. Researchers from Rwanda assumed there is a possible relation between the~     level of foreskin odor to the patient foreskin hygiene technique. It was speculated that a~     patient that follows an appropriate foreskin hygiene technique while wearing the device will~     have a significantly lower foreskin odor on day 7 than a patient who does not follow such~     technique. The Government of Rwanda decided to investigate those assumptions in a scientific~     way and conduct a study to test different hygiene cleaning methods in order to increase the~     acceptability of PrePex and mitigate the odor concern.~   "
69041|NCT02153645|"~     Amantadine has been used for many years as a treatment for Parkinson's disease. It has been~     reported in the literature to effectively treat the motor complications of levodopa,~     especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this~     multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the~     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to~     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's~     disease. The dose will be given once a day in the morning so that amantadine concentrations~     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be~     lower during the night, potentially reducing the negative impact of amantadine on sleep.~   "
69069|NCT02153281|"~     The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution~     volume (VT), after phenelzine treatment and if so to what extent.~   "
69070|NCT02153268|"~     Phase I/II open label first in human single center clinical study, is to evaluate the safety~     and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose~     tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area~     approximately 6 month follow up after implantation in the following two clinical~     indications:~        1. Bone augmentation (e.g. sinus augmentation)~        2. Bone grafting after removal of cysts from jaws~   "
69042|NCT02153632|"~     Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It~     has been reported in the literature to effectively treat the motor complications of~     levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of~     this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the~     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to~     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's~     disease. The dose will be given once a day in the morning so that amantadine concentrations~     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be~     lower during the night, potentially reducing the negative impact of amantadine on sleep.~   "
69043|NCT02153619|"~     Many parents who have lost a child use counseling or other resources to help with the~     emotional burden of their loss. The aim of this study is to begin to test a new counseling~     program for parents who have lost a child to cancer.~   "
69044|NCT02153606|"~     All premature babies have problems with feeding and nutrition. Some can develop a~     life-threatening bowel infection necrotizing enterocolitis. This can result in the need for~     emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature~     babies glycerin suppositories may be one way to stimulate the digestive tract and help~     prevent these problems. To see if this treatment works, the investigators need to study~     hundreds of premature babies in a large trial involving multiple hospitals. The purpose of~     this project is to carry out a small study first and make sure that the larger trial is~     feasible. The investigators will invite approximately 30 premature babies from the Neonatal~     Intensive Care Unit at McMaster University Medical Centre to participate in this study over~     a 6-month period. The investigators will focus on feasibility issues, including cost,~     safety, and rate of participation. This will allow us to rigorously test our study protocol~     and lay the groundwork for the larger study involving multiple hospitals.~   "
69045|NCT02153593|"~     Massive bone tumour resection is often associated with important postoperative bleeding.~     This may determine systemic (anaemia), as well as local complications (wound healing,~     seroma, haematoma).~      The objective of this study is to determine whether the use of topical tranexamic acid or~     topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.~   "
69046|NCT02153580|"~     This phase I trial studies the side effects and best dose of cellular immunotherapy~     following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic~     leukemia or B-cell prolymphocytic leukemia that has come back. Placing a modified gene into~     white blood cells may help the body build an immune response to kill cancer cells.~   "
69047|NCT02153567|"~     Background:~      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of~     functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that~     FD is strongly associated with common mood disorders especially depression and anxiety~     disorders, which can be treated with serotonin selective uptake receptor (SSRI).~      Our previous study shows that the relief of FD symptom has an association with the change of~     plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin~     level in FD patients treated with SSRI is lacking in these studies.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims :~        -  To evaluate the effect of SSRI treatment on change of plasma serotonin level~        -  To evaluate the relationship between dyspeptic symptom and change of plasma serotonin~          level~      Study medication:~      Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus~     Placebo for 10 weeks~      Study design:~      Double-blind randomized placebo-controlled trial~      Number of subjects:72~      - 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls~      Patient population:~      Functional dyspepsia patients age 18-60, with element of anxiety or depression~      Duration of study: 1 June 2013 - 30 November 2015~      Primary variable(s):~      Change of serotonin and ghrelin level in blood plasma after medication treatment~      Secondary variable(s):~      Rate of adequate relief using global symptom assessment and symptom scores~      Number of visits: 2~   "
69048|NCT02153554|"~     The purpose of this study is to determine whether the training of civil servants leads to a~     reduction in the violence suffered by women, as well as in their psychological wellbeing and~     attitudes towards violence.~   "
69049|NCT02153541|"~     This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults~     with poorly controlled moderate to severe asthma. The researchers believe that by using a~     local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma,~     such as decreasing the numbers of times patients have to use a rescue inhaler, and improving~     asthma treatment assessment questionnaire scores, with no bad changes to lung function and~     inflammation.~   "
69050|NCT02153528|"~     - Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion~     using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without~     excess serious toxicity, and allows early switch to specific treatment of MDR-TB without~     using Cat. 2 retreatment regimen~      - General study design: This open label, randomised clinical trial is intended as a pilot~     study on the efficacy and safety of high-dose rifampicin and feasibility and added value of~     auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase.~     If this proof-of-concept study provides substantial indication of benefit without indication~     of excess toxicity, the data from the study will be used to design a larger scale,~     cluster-randomized study. The aim of this cluster randomised study would be to provide~     definite proof of the benefit of the intervention on adverse treatment outcomes and lack of~     excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized~     study would provide a more precise assessment of the suppression and prevention of~     (acquired) resistance endpoints.~      An interim analysis is thus planned at the time the last recruited patient finishes~     treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of~     drug toxicity versus suggested benefits of the intervention. This analysis will be primarily~     performed for the go/no-go decision and design considerations for the cluster-randomized~     trial. The decision on proceeding to the cluster randomized study will be based on the~     absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding~     relapse), and possible favourable effects on initially present low-resistance mutations /~     mutations acquired during treatment. It will also allow to adapt the design of the larger~     study particularly regarding the algorithm for resistance screening, and whether or not~     treatment shortening could be justified with rapid initial conversion.~   "
69051|NCT02153515|"~     To investigate if fresh finger prick autologous blood (FAB) instead of serum from~     venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial~     defects. Currently there are no studies on the use of whole fresh blood for the treatment of~     chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate~     that fresh blood can be an effective tool to the treatment of corneal pathology.~   "
69055|NCT02153463|"~     Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS)~     is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic~     disorders affect up to 8% of children. Peak severity of tic disorders occurs between the~     ages of 8 to 12 years, therefore during childhood and adolescence the most significant~     impacts are felt. The quality of life of young people with tics is lower than their peers'~     and tic severity predicts lower quality of life. Studies have also shown negative social~     perception toward children with tics.~      Approximately 50% of patients with Tourette syndrome will have other diagnoses including~     attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and~     depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic~     disorders are thought to involve the same areas of the brain; thus it is possible that tics~     might also improve with physical activity. However, no studies to date have examined this.~     The investigators predict that by implementing a motivational physical activity program, in~     conjunction with physical activity counseling, the investigators will be able to increase~     levels of physical activity in children with tics and Tourette syndrome, with a positive~     impact on tic severity.~   "
69056|NCT02153450|"~     This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in~     treating patients with pancreatic cancer that may be removed (borderline-resectable) or not~     removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes,~     may also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic~     radiosurgery with metformin hydrochloride may kill more tumor cells.~   "
69057|NCT02153437|"~     To determine the effect of our compound (BMS-919373) on electrical activity of the heart~     using pacemakers.~   "
69058|NCT02153424|"~     The primary objective of the study is to identify and describe any suspected (AEs) in all~     patients with NVAF treated with Apixaban, as a request of the National Center of~     Pharmacovigilance (CNFV) in Mexico.~   "
69059|NCT02153411|"~     Descriptive study on the management of asthma in asthmatic Middle East adult population :~     Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE~   "
69060|NCT02153398|"~     The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and~     efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in~     Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are~     suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU),~     non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison~     syndrome.~   "
69061|NCT02153385|"~     Background: Women are more likely to suffer from depression and anxiety, which have been~     linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and~     mortality. The purpose of this study was to examine the effects of an 8-week yoga program on~     HRV and mood in generally healthy women. The investigators hypothesized that there would be~     improvements in HRV and reductions in perceived stress and symptoms of depression and~     anxiety after the yoga intervention.~      Methods: Fifty-two healthy women were randomized to either a yoga group or a control group.~     Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute~     session, twice a week. Each session consisted of breathing exercises, yoga pose practice,~     and supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms,~     and state and trait anxiety were assessed at baseline and week 9.~   "
69062|NCT02153372|"~     In the present phase-I clinical trial we investigate safety and feasibility of an~     augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in~     combination with an angle stable fixation (Philos plate®) for the therapy of proximal~     humeral fractures.~   "
69063|NCT02153359|"~     This study is about asthma and how the environment affects asthma. Scientists know that air~     pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms~     worse. This research is being done to study how the health of a person with asthma responds~     to an air cleaner. The investigator hypothesize that an air cleaner will improve the health~     of persons with asthma.~   "
69064|NCT02153346|"~     Rationale Asthma is a chronic inflammatory disorder of the airways affecting persons of all~     ages and is recognized as one of the most common chronic diseases. Canada has one of the~     highest asthma prevalence rates in the world (8.5%, aged 12 and over) and it is a major~     cause of hospitalization. The cost of asthma varies dramatically across disease severity,~     and it is expected that these costs are greater when the condition is sub-optimally managed~     and controlled. Although a number of publications have been reported on the economic burden~     of asthma, there is a lack of information on the cost of asthma based on disease severity~     and level of disease control in Canada. The proposed study aims to i) estimate the annual~     indirect cost of asthma and ii) the impact of asthma on absenteeism, presenteeism and work~     productivity in Canada. This information is essential to further quantify the burden of~     asthma on patients and the healthcare system in the Canadian setting.~      Overall Objectives The overall objective of this study is to describe the impact of asthma~     on patients with moderate to severe asthma and to estimate the indirect costs of asthma care~     in asthmatic patients followed in tertiary clinics specialized in the field of asthma in~     Quebec, Canada.~      Study Design~      A prospective cohort study will be conducted to measure the indirect economical burden of~     asthma on patients. Patients will be selected and recruited from the BD-Asthma registry and~     followed prospectively for 1 year. Recruited patients will be asked to complete~     questionnaires at regular intervals for 1 year to measure indirect cost of disease, using~     the Valuation of lost productivity (VOLP) questionnaire.~      Data Collected For each patient, the following data will be collected~        -  Patient demographics~        -  Age~        -  Sex~        -  Income~        -  Level of education~        -  Smoking~        -  Disease management and Treatment utilization in the year prior to recruitment~        -  Physician visits and follow up~        -  Hospitalizations (number and total days)~        -  Emergency room visits~        -  Disease characteristics~        -  Asthma history~        -  Year of first diagnosis of asthma severity~        -  Asthma Control Questionnaire score~        -  Lung function measures~      Data Analysis Methods For each participant, the percentage of time missed from work over a~     year will be calculated. We will use the human capital approach to calculate the costs of~     asthma due to lost productivity, incorporating both absenteeism and presenteeism in the~     calculation of the productivity loss. We will calculate the number of work days in which the~     person was unable to attend the workplace, and the number of days and percentage of time~     lost during the days the person's work was affected by their asthma. The fraction of time~     lost from work in the past year will be multiplied by the average income in Quebec. Finally,~     this value will be multiplied by the coefficient generated by the VOLP, which reflects the~     relative value of the productivity loss. In addition, we will calculate the VOLP multiplier~     for each participant which, combined with the percentage of time missed from work, will~     create a measure of productivity loss adjusted for the relative importance and~     replace-ability of the participant's profession.~      Sample Size and Power~      One hundred subjects will be randomly selected from the BD-Asthma registry.~      Limitations~      The study population may not be representative of the general asthma population, as moderate~     to severe asthma will be over represented in these tertiary centers.~   "
69065|NCT02153333|"~     This study aims to evaluate the serologic response to PCV-1 in the serum samples previously~     collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies~     (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera~     samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time~     point will also be evaluated.~   "
69066|NCT02153320|"~     The purpose of this long-term follow-up study was to evaluate the persistence of the~     cellular and the humoral immune response 4 years after the first dose of GSK Biologicals'~     investigational vaccine formulations containing HBsAg (used as a model antigen) and an~     adjuvant.~   "
69067|NCT02153307|"~     The purpose of this study is to determine the incidence and predictors of high degree or~     complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset~     persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve~     implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac~     Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant~     arrhythmias in patients with NOP-LBBB following TAVI.~   "
69068|NCT02153294|"~     The purpose of this national multicentre randomized controlled trial is to compare a~     ventilation strategy using lower tidal volumes and higher respiratory rates with a~     ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated~     and ventilated intensive care unit (ICU) patients without Acute Respiratory Distress~     Syndrome (ARDS) at start of ventilation.~      Participating centres in The Netherlands will include a total of 952 adult patients admitted~     to intensive care units without ARDS. Patients are randomized and ventilated with either a~     strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy~     with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day~     28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90.~     Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are~     ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of~     ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of~     sedatives, and neuromuscular blocking agents, incidences of ICU delirium and ICU acquired~     weakness, patient-ventilator asynchrony and the need for decreasing of instrumental dead~     space.~   "
69071|NCT02153255|"~     Mucopolysaccharidosis Type IVa (MPS IVa, Morquio Disease) is a rare inherited lysosomal~     storage disorder caused by deficiency of the enzyme galactose-6-sulfatase.~      Children with this disease accumulate a chemical called keratan sulphate, which stops their~     skeletons developing properly. They are very short in stature and many of their joints are~     unstable. Children with MPS IVa walk in a different way to other people due to a combination~     of lax ligaments and skeletal problems such as knock-knees.~      Human walking involves the coordinated movements of all four limbs. As we walk, the arms~     swing oppositely to the legs. This movement pattern is very different in children with MPS~     IVa. This change seems to involve the whole musculoskeletal system and depends on the~     severity of the disease.~      Recent studies in children with MPS IVa describing walking pattern have concentrated solely~     on the lower or upper limb respectively, and have not looked at the interaction of the upper~     and lower limbs during walking.~      To our knowledge, the mechanics of walking in children with MPS IVa has not been~     investigated using a dynamic gait analysis tool (using cameras, sensors and electrodes to~     track the movements of different parts of the body during walking) and we aim to~     characterise this in a small number of children with MPS IVa and also examine the effects of~     splinting the wrist upon the walking pattern to see if this simple intervention makes it~     easier or more difficult for children with MPS IVa to walk.~   "
69072|NCT02153242|"~     This is a pilot study into the effects on heart function when pacing the right ventricle~     (RV). This study aims to enrol a population with structurally normal hearts. The~     investigators aim to measure heart function directly when pacing.~      When normal conduction within the heart fails, the treatment may be to implant a permanent~     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical~     impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been~     shown to be less efficient than the normal conduction system of the heart and in some cases~     leads to markedly reduced function. What the investigators do not know is why this is the~     case.~      Much effort has been directed at looking at features within the left ventricle (LV) for~     markers of disease progression but little has been investigated regarding the RV.~      There may be some benefit to pacing the heart preferentially from different parts of the RV~     and the investigators aim to measure if any differences are detectable from stimulating the~     heart at various sites within the RV.~   "
69073|NCT02153229|"~     A randomized Phase II trial to test whether the addition of intraoperative~     Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative~     chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to~     the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive~     maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment~     using real-time, isotropic light dosimetry.~   "
69074|NCT02153216|"~     This study is the Formative Phase of a larger study; once this phase is completed,~     enrollment into the randomized controlled trial (RCT Phase) will begin. The primary~     objective of the Formative Phase is to gain a better understanding of the context in which~     drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the~     intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to~     40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the~     ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not~     recruited from the ART clinics (whom we will refer to as general population PWID).~   "
69075|NCT02153203|"~     Children with autism spectrum disorders often engage in problem behaviors such as~     self-injury, destruction, aggression, and stereotypy. Prior research has clearly shown that~     these problem behaviors may interfere with learning, daily functioning, and social~     participation. As such, engaging in problem behaviors has a negative impact on the health~     and quality of life of children with autism spectrum disorders and their families. One~     promising solution to reduce problem behaviors in this population is the~     Prevent-Teach-Reinforce (PTR) model, which relies on the evidence-based practices of~     positive behavior support. Although the use of PTR has been gaining considerably support in~     schools, the model has never been evaluated as part of a rigorous large-scale study using~     parents as interventionists. Thus, the purpose of the project is to conduct an assessment of~     the effectiveness of a home-based version of the PTR model in reducing problem behaviors in~     children with autism spectrum disorders and in improving families' quality of life. Our~     hypotheses are that implementing the PTR will (a) produce larger reductions in problem~     behaviors than participating in an individual parent training session, (b) increase~     engagement in prosocial behaviors, (c) decrease parental stress, and (c) improve the quality~     of life of the family. The results of the study will allow an examination of whether PTR is~     an effective and acceptable model to reduce problem behaviors at home in this population.~     Given that problem behaviors incur high societal costs when they persist into adolescence~     and adulthood, the study may potentially lead to large cost reductions in the treatment of~     difficulties associated with autism spectrum disorders. By reducing engagement in problem~     behaviors, the implementation of the model may also promote and facilitate the social~     participation as well as improve the quality of life and health of children with autism~     spectrum disorders and their families.~   "
69076|NCT02153190|"~     The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in~     home setting in Type 1 Diabetic patients~   "
69077|NCT02153177|"~     The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory~     Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.~   "
69078|NCT02153164|"~     This is a single site, prospective, non-blinded, non-randomized, non-interventional study~     designed to evaluate the effect of changes in patient position on the measurement of~     respiratory heat loss (enthalpy). This study would be carried out on patients whose~     operation requires the use of the steep Trendelenburg position independent of this study.~   "
69079|NCT02153151|"~     This pilot research trial studies the response in blood cells to AMP-514, a drug shown to~     increase immune response (capacity to fight against infections and cancer) against cancer in~     patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help~     doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to~     combine the drug with radiation.~   "
69080|NCT02153138|"~     The investigators' hypothesis is that a plant-based diet may be beneficial if nutritional~     deficiencies will be corrected. The aims of the present proposal are to 1) study endothelial~     functions of subjects on well-defined vegetarian/vegan diets compared to age and sex matched~     omnivores (controls), and 2) study the differences in energy expenditure, body composition,~     overnight substrate utilization, blood work results, and levels of intracellular reactive~     oxygen species (ROS) and of adhesion molecules on the different diets.~   "
69081|NCT02153125|"~     The aim of the study is to determine the efficacy and safety in treating patients with~     chronic central serous chorioretinopathy with the drug eplerenone.~   "
69082|NCT02153112|"~     The purpose of this study is to select the optimal formulation of the norovirus vaccine from~     different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for~     further development in children.~   "
69087|NCT02153047|"~     There is controversy about the effectiveness of interventions based on spirometry for~     smoking cessation.~      The investigators want to evaluate the effectiveness of motivational intervention performed~     by a doctor to obtain abstinence compared with normal practice in primary care.~      This study, is the second half of what was began with ESPITAP study~   "
69088|NCT02153034|"~     Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans~     (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to~     15 years. Access to treatment is limited and many cases present late. There have been major~     advances in understanding the mechanism of disease together with improved diagnosis and~     management. The aim of the proposed studies is to identify markers predictive of a rapid~     response to antibiotic treatment and to investigate the pathogenesis of paradoxical~     reactions and oedematous lesions in Mu disease.~      Infection with Mu results in a nodule under the skin which enlarges and breaks down to form~     an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous~     tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily~     tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better~     if the treatment could be shortened. Our previous studies suggest this may be possible.~     Therefore a wide range of tests will be investigated in order to identify markers for people~     in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of~     toxin in the skin. During antibiotic treatment the rate of healing will be measured to find~     out which markers are the most reliable.~      In some patients new areas of inflammation develop despite treatment and this is called a~     paradoxical reaction. The immune response to Mu will be investigated serially during~     antibiotic treatment to investigate the cause of paradoxical reactions.~      About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will~     study the amount of Mu toxin produced by the strain of Mu cultured from patients with this~     form of the disease.~      Hypothesis~        -  Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with~          treatment will have associated predictive viability or serum biomarkers.~        -  Buruli ulcer patients with oedematous disease are associated with larger amounts of~          mycolactone and viable organisms~   "
69089|NCT02153021|"~     Obesity is a chronic disease of increasing prevalence, being currently considered a global~     epidemic, including children, adolescents, adults and the elderly of different nationalities~     and ethnicities, socioeconomic levels, education levels. Non-pharmacological therapeutic~     interventions, such as physical exercise and fitness healthy eating strategies seem to be~     increasingly studied and recommended for healthy weight loss. In addition, therapies that~     can complement the effect of exercise and diet for reducing body weight are considerate~     important strategies. Thus, experimental evidence shows that the use of laser therapy~     combined with exercise swimming was effective in controlling the lipid profile, reducing the~     mass of adipose tissue, suggesting increased metabolic activity and changes in lipid~     metabolism.~      To investigate the effect of the use of therapeutic laser when associated to exercise like~     response to new therapy for weight loss and decrease of dyslipidemias levels.~   "
69090|NCT02153008|"~     To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs~     collected from symptomatic subjects.~   "
69091|NCT02152995|"~     This phase II trial studies how well trametinib works in increasing tumoral iodine~     incorporation in patients with thyroid cancer that has come back or spread to another place~     in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and may help make treatment with iodine I-131 more effective.~   "
69092|NCT02152982|"~     This randomized phase II/III trial studies how well temozolomide and veliparib work compared~     to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether temozolomide is more effective~     with or without veliparib in treating glioblastoma multiforme.~   "
69093|NCT02152969|"~     To evaluate Drug-drug interaction~   "
69094|NCT02152956|"~     The primary goal of this Phase 1, dose-escalation study, is to determine the maximum~     tolerated dose level of MGD006 in patients with AML and MDS whose disease is not expected to~     benefit from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in~     the body (pharmacokinetics [PK], pharmacodynamics) and to evaluate potential anti-tumor~     activity of MGD006.~   "
69095|NCT02152943|"~     The goal of this clinical research study is to find the highest tolerable dose of Femara~     (letrozole) that can be given in combination with Afinitor (everolimus) and Herceptin~     (trastuzumab) to patients with advanced cancer. The safety of this drug combination will~     also be studied.~   "
69096|NCT02152930|"~     Intermittent claudication (IC) is caused by peripheral arterial disease and has a high~     morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease.~     Primary treatment consists of cardiovascular risk management and improvement of functional~     capacity with supervised exercise therapy (SET). A potential additional therapy is the~     administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated~     Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved~     hemorheological parameters such as erythrocyte deformability and aggregation, and a number~     of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the~     microcirculation, which is of main importance in patients with IC since the macrocirculation~     is compromised. Inflammation is considered an important etiologic factor in the pathogenesis~     of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also~     have a strong anti-inflammatory effect, they might be effective in patients with IC by~     lowering the inflammatory response. In addition, visceral fat rather than obesity in general~     has been recognised as an etiologic and prognostic factor in atherosclerosis.~      We hypothesise that the administration of omega-3 PUFA's in patients with IC has a~     synergistic effect with SET and improves walking distance after SET, by improving~     hemorheological parameters resulting in a better microcirculation. Second, we hypothesise~     that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo~     stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a~     decrease in visceral fat mass.~   "
69108|NCT02152774|"~     To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%)~     ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6~     months.~      Secondary Outcome~      Secondary objectives are:~        1. To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular~          pressure (IOP).~        2. To evaluate the long term effect of the drug on IOP.~        3. To determine if AR-12286 can be used as directed therapy for CACG, reducing or~          eliminating the structural blockage of the trabecular meshwork that leads to~          development of elevated IOP.~   "
69109|NCT02152761|"~     The purpose of this study is to assess if bimagrumab is safe and effective in patients with~     muscle wasting (atrophy) after hip fracture surgery.~   "
69097|NCT02152917|"~     The total knee arthroplasty (TKA) is a well established option for the treatment of~     osteoarthritis in this joint. Nevertheless, there are still some concerns related to the~     peri-operative management of elderly patients, highlighting the complications related to~     medical comorbidity and bleeding produced by surgery. One of the proposed methods to~     decrease postoperative bleeding, which has been accumulating favorable evidence, is the use~     of tranexamic acid (TA). Several studies (including prospective randomized trials with~     placebo group) showed excellent results with TA intravenous administration during TKA,~     reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion.~     Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®,~     composed of thrombin and bovine gelatin. This substance has presented significant benefits~     on bleeding control in several areas of medicine, including orthopedic surgery, but no~     action has yet been established in TKA. The main objective is to evaluate the amount of~     bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the~     use of TA, Floseal® and a control group. The secondary objective is to evaluate the rate of~     adverse events in the studied groups.~   "
69098|NCT02152904|"~     The purpose of the investigators study is to investigate the factors associated with~     rebleeding in patients with peptic ulcer bleeding.~   "
69099|NCT02152891|"~     Older adults living in subsidized housing report poorer health. Their age and low income~     make it harder for them to use community services. Many older adults have heart disease and~     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the~     costs of treating heart disease and diabetes through emergency and hospitalization, improved~     screening and health education is needed. Our program will take place in communal areas~     within housing buildings of older adults and deliver a heart disease, diabetes, and falls~     risk check-up with health education. This is expected to improve the health of older adults~     leading to fewer emergency calls and hospital visits.~   "
69100|NCT02152878|"~     Non-invasive brain stimulation therapies have been increasingly investigated in recent years~     as a treatment for neuropsychiatric disorders, particularly mood disorders. They are~     particularly appealing since many patients are either refractory or present side effects to~     standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel~     non- pharmacological brain stimulation technique, might help in overcoming some of these~     issues, since it has low cost, high portability and it is relatively easy to use. TDCS~     consists in applying a weak, direct current through two electrodes placed over the scalp;~     the anode and the cathode increasing and decreasing cortical excitability during and beyond~     the period of stimulation. It is also a safe technique with only mild adverse effects~     described. Previous studies, some of them from our group, have described that tDCS is an~     effective technique for major depression. However, the role of tDCS as a treatment for~     bipolar depression (BD) has been insufficiently investigated. Therefore, our aim is to~     address the antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in~     a refractory sample.~   "
69101|NCT02152865|"~     For the chemical lupeol isolated from eggplant, we applied it to one side of face, and~     applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week,~     randomized controlled, split face fashion. Investigators evaluated safety and efficacy~     during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.~   "
69102|NCT02152852|"~     The purpose of this study is to test the hypotheses that CHWs providing in-home support for~     self-management of type 2 diabetes, resources for diabetes, and assistance in effective~     linkage and communication with medical providers will: (1) improve HbA1c (primary outcome)~     and secondary outcomes including lipids, blood pressure, health care utilization, and~     health-related quality of life; (2) improve diabetes self-management, including~     self-efficacy, physical activity, nutrition, and medication adherence; and (3) be~     cost-effective and feasible.~   "
69103|NCT02152839|"~     Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we~     lose on average 1-2% of our muscle each year. In order to slow this loss we need to~     understand fully the mechanisms regulating muscle mass with ageing. In this project we aim~     to determine these mechanisms using a new novel technique of 'heavy' water ingestion, which~     will allow us to measure multiple aspects of skeletal muscle mass control during normal~     everyday activities in young and old individuals over a period of 6 weeks. We will also~     determine the influence of resistance exercise training during this period in offsetting~     declines in muscle with ageing using this method~   "
69104|NCT02152826|"~     This study will compare the safety and effectiveness of two water-based potassium oxalate~     desensitizers on existing dentinal hypersensitivity.~   "
69105|NCT02152813|"~     This proposed study aims to compare the effects of unilateral and bilateral transcutaneous~     electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +~     task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength,~     co-ordination, dynamic standing balance, walking performance, and functional mobility in~     patients with chronic stroke.~      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not~     significantly different in promoting the recovery of these functions.~   "
69106|NCT02152800|"~     The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in~     patients with acute herpes zoster.~   "
69107|NCT02152787|"~     The occurrence of emergence agitation (EA) in pediatric patients who have received~     sevoflurane anesthesia is a common postoperative problem. Among various strategies for~     reducing the incidence and severity of EA, the use of pharmacological agents at the end of~     anesthesia is thought to be the most convenient and easily applicable method in clinical~     situation. The one of typical agents that can be administered in this way is propofol.~     Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could~     reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However,~     it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could~     delay the emergence time. The purpose of this study is to compare the preventive effect on~     EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the~     end of sevoflurane anesthesia.~   "
69128|NCT02152514|"~     The purpose of the study is to determine if the administration of a mix of Sufentanil and~     Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.~   "
69110|NCT02152748|"~     Summary of scientific evidence and rationale of this project:~      Integrative molecular-genetic approaches have provided important insights in the biology of~     glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity~     but comprises different molecular subtypes, which are associated with a distinct~     genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio-~     and chemotherapy as well as the recent introduction of novel antiangiogenic agents have~     resulted in increasing survival times and improved quality-of-life of glioblastoma patients.~     Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma~     patients is limited, leading in virtually all cases to tumor recurrence and death of the~     patients.~      As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor~     recurrence (< 10%), post-therapeutic samples are rare and no systematic, large-scale studies~     exist, which address post-therapeutic morphological and molecular alterations in~     glioblastoma tumor tissue. Yet, these data would help to improve the understanding of~     mechanisms involved in therapy-resistance and tumor progression, to develop new therapeutic~     approaches and could pave the way for personalized treatment strategies.~   "
69111|NCT02152735|"~     PURPOSE:~      To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries~     does not increase intraoperative and postoperative complications.~      METHODS:~      We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning~     (n=103) versus no cleaning (n=103) of the uterine cavity following placental delivery. Women~     will be excluded if any of the following criteria are encountered: preterm premature rupture~     of membranes, spontaneous rupture of membranes prior to cesarean section, chorioamnionitis,~     fetal demise, uncontrolled diabetes or an immunosuppressive disorder. Primary outcome~     measure will be endo-myometritis after delivery. Secondary outcomes will include post partum~     hemorrhage, mean surgical time, retained products of conception, retained placenta,~     quantitative blood loss, length of hospital stay, return of gastrointestinal function,~     repeat surgery, and hospital readmission rates. Analysis will follow the intention-to-treat~     principle.~      GENERAL DESIGN All eligible patients who are scheduled for cesarean section at the Sparrow~     hospital/Michigan State University Resident OBGYN and Perinatology clinics will be evaluated~     for study inclusion. Patients meeting this study's inclusion criteria and lack exclusion~     criteria will be approached for consent and enrollment.~   "
69112|NCT02152722|"~     The effect of radiation on normal tissue varies widely between individuals. Consequently, a~     test to measure tissue response to radiation could be clinically useful by permitting more~     accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging~     concerns about possible nuclear terrorism a test for exposure to radiation might also be~     useful in evaluating victims of a dirty bomb explosion. A number of different techniques~     have been previously reported in epidemiological studies for the estimation of prior~     radiation exposure. This study explores one approach to estimating radiation exposure by~     measurement of increased oxidative stress which can be detected by a breath test.~      In this study subjects undergoing significant exposure to therapeutic radiation will provide~     breath samples for analysis in a central laboratory. The hypothesis of the study is that the~     analysis of these samples will lead to the identification of a set of markers of radiation~     exposure.~   "
69113|NCT02152709|"~     The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml~     and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in~     saccharomyces cereviside yeast for infants and other age groups.~   "
69114|NCT02152696|"~     This is a randomized controlled trial to compare three currently available management~     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes~     them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a~     confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed~     by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic~     pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. Randomization will~     be 1:1:1 into these three arms. After randomization, they will be followed and treated~     clinically as is indicated by the progression of their condition. Primary outcome measures:~     uneventful decline of hCG to 5 IU/mL.~   "
69115|NCT02152683|"~     The study is aimed at comparing the performance of protocols employing one and two sessions~     per week, respectively. The study hypothesis claims that there is no significant difference~     between the performances of the compared protocols.~   "
69116|NCT02152670|"~     Studies using positron emission tomography (PET) have been used with great success in~     demonstrating specific abnormalities in several facets of dopaminergic system function in~     human populations (Narendran and Martinez 2009). Among the first, most consistent, and~     broadly replicated of such findings in drug‐ (including cocaine) dependent individuals has~     been the reduction in subcortical (striatal) D2/3 receptors as imaged, most commonly, by the~     reversible, non‐selective, D2/3 receptor antagonist radiotracer, [11C]raclopride. Certain~     dissociations on D2/3 availability by radioligand ([11C]raclopride vs. [11C]PHNO) and by~     brain region (striatum vs. SN; terminal vs. somatodendritic, respectively) are poorly~     understood in relationship to prior antagonist tracer results. In the current study the~     investigators will use pharmacological interventions (AMPT and methylphenidate) with both~     antagonist and agonist radiotracers to experimentally reconcile these discordant findings~     and clarify potential mechanistic inter‐relationships.~   "
69117|NCT02152657|"~     The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell~     transplantation through percutaneous injection in patients with chronic spinal cord injury.~   "
69118|NCT02152644|"~     This is a cross sectional study to estimate the prevalence of the presence of amyloid~     deposits in a biopsy of subcutaneous fat cell, carpal flexor retinaculum and synovial tissue~     sheath of the flexor tendons requirement for carpal tunnel surgery.~   "
69119|NCT02152631|"~     The main purpose of this study is to evaluate how safe and effective the study drug known as~     abemaciclib is in participants with lung cancer.~   "
69120|NCT02152618|"~     The intervention provides services to children with Serious Emotional Disturbance (SED) who~     are in foster care and to their parent(s) to prepare the families for reunification.~   "
69129|NCT02152501|"~     The purpose of this study is to research the effects of exercise on calories eaten and~     expended. The investigator expects to find out whether subjects change their eating and~     activity behaviors when starting an exercise program.~   "
69121|NCT02152605|"~     This study is a 12-week, multicenter, randomized, double blind, parallel group,~     placebo-controlled study.~      The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25~     microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory~     Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in~     the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it~     provides an objective measure to support the subjective patient reported outcomes of SGRQ~     and rescue medication use. The study is intended to provide additional evidence to support~     the use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be~     randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks~     of treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1~     ratio. All treatments will be administered once-daily in the morning via a Dry Powder~     Inhaler (DPI).~      There will be a total of 5 clinic visits. The total duration of study participation will be~     approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as~     needed for the relief of COPD symptoms throughout the run-in and double-blind treatment~     periods.~   "
69122|NCT02152592|"~     the primary objective of this study is to assess and compare the efficacy, safety and~     benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol~     (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful~     day-case surgery. We hypothesize that ambulatory patients postoperatively treated with~     oxycodone/paracetamol will achieve better pain relief with equal side effects compared to~     patients treated with paracetamol/naproxen.~      Our second goal is to assess analgesic adherence in the outpatient setting.~      Endpoints:~      Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: -~     side-effects/ adverse effects of study medication~        -  patient satisfaction with pain treatment~        -  compliance to study medication~      Study design:~      Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or~     laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial~     (RCT) at our pre-assessment clinic.~      Subjects will be enrolled by a study nurse and will be randomized into one of three study~     treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are~     assigned to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours~     postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally~     twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch~     CR oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol~     1000 mg orally four times a day for 48 hours postoperatively.~      Recovery after discharge will be assessed using a diary for up to 48 hours after surgery.~     Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea,~     vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore,~     compliance to the use of the study medication will be assessed by checking whether the~     patients took the study medication as prescribed and if any other pain medication was used.~     Compliance will be assessed three times a day and patients will be divided into three groups~     according to medication use: always = full compliance, sometimes = partial compliance, or~     never = no compliance.~      Finally, overall satisfaction with the postoperative pain treatment will be assessed (score~     0-10).~   "
69123|NCT02152579|"~     Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide~     mononitrate from the incidence of events (angina episodes).~      This is an open, comparative, monocentric trial. The hypothesis, regarding the number of~     angina episodes, to be tested are:~        -  H0: μD = 0 ot H0: μAfter = μBefore~        -  HA: μD ≠ 0 ot HA: μBefore ≠ μAfter~   "
69124|NCT02152566|"~     Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in~     the blood during the night, which has been shown to contribute to a range of morbidities.~      The purpose of this study is to assess the possibility that a nasal high flow therapy device~     may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing~     reduction in blood oxygen.~      Heart failure patients will be screened at a heart failure clinic, and will be asked to~     undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies~     during sleep. This sleep study may be completed in the sleep laboratory (attended~     polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with~     respiratory insufficiencies, they will be asked to attend further overnight studies to see~     if treatment with nasal high flow therapy can be used to stabilize breathing.~   "
69125|NCT02152553|"~     The investigators have shown that patients with adrenal insufficiency (Addison's disease), a~     rare disorder, have doubled the expected mortality rate in Sweden despite Standard of Care~     glucocorticoid (GC) replacement. One % of the Swedish population are, however, receiving GCs~     for inflammatory diseases, but management is empirical and adjusted to underlying disease~     activity. The desired anti-inflammatory therapeutic effects cannot be differentiated from~     the adverse metabolic (osteoporosis, obesity, diabetes mellitus) and immunosuppressive side~     effects of GC. This frequently results in suboptimal GC therapy with adverse effects due to~     over-dosing or poor efficacy due to under-dosing. The primary aim is to identify a biomarker~     for the metabolic effects of GCs. Patients with Addison's disease completely lack endogenous~     GCs and can therefore be considered a human GC knock-out model. They can therefore be~     studied during near-physiological exposure and during GC starvation. This will uniquely~     allow a very clean biomarker identification model (using transcriptomics, proteomics and~     metabolomics). The secondary aim is to validate candidate biomarker(s) in a dose-response~     study using the same patient population. A biomarker of GC actions will make it possible to~     individualised therapy during pharmacological GC treatment. It would allow GC replacement to~     be monitored in Addison's disease and could become a specific diagnostic tool in patients~     with GC deficiency and excess (Cushings syndrome).~   "
69126|NCT02152540|"~     This project will study 40 Veterans identified with symptoms understood to characterize mild~     to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD).~     Following screening and informed consent, Veterans will be randomly assigned to treatment~     with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional~     examinations will compare brain imaging (structural and functional MRI scans at rest) across~     participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA~     population differs significantly from populations that have been included in prior trials of~     rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning~     Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with~     concussion histories report cognitive problems, such as impaired attention, verbal fluency,~     poor planning, reduced working memory, and mental flexibility. The investigators hope to~     show the efficacy and durability of rTMS in treating these symptoms safely in Veterans with~     co-morbidities.~   "
69127|NCT02152527|"~     Trimetazidine (1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride) is a clinically~     effective antianginal agent. Despite these clinical successes, the understanding of~     trimetazidine's mechanism of action remains incomplete, particularly influence of~     trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators~     will perform this study to seek possible differences in mitochondrial respiration related to~     standard preoperative enrolled trimetazidine therapy.~   "
69130|NCT02152488|"~     Rotation or flexion of the cervical spine is unavoidable during positioning for some~     surgical procedures as carotid endarterectomy, thyroidectomy and surgery of the shoulder.~     Rotation or flexion may reduce blood flow in the carotid or vertebral arteries and induce~     intraoperative cerebral ischemia with impact on the neurological outcome of surgery.~     Predominantly if the circulus willisii is incomplete because of congenital variation,~     collateral arteries may not be sufficient to compensate reduced blood flow in one carotid or~     vertebral artery. This may be aggravated by intraoperative hypotension in limits tolerable~     under normal conditions but fatal during impairment of vascular conductivity by positioning.~     The middle cerebral artery (MCA) is a final large scale pathway of cerebral blood flow and~     hence relevant reduction of flow in the MCA may serve as a surrogate parameter for relevant~     reduction of cerebral blood flow caused by carotid stretching or narrowing.~      Objective of this study is to investigate, if MCA blood flow in normal male and female~     subjects, aged 18 to 85 years, is reduced in extended and rotated cervical spine position in~     comparison to neutral position.~   "
69131|NCT02152475|"~     Photodynamic therapy (PDT) is a technique used for the oral disinfection. In dentistry, PDT~     for microbial inactivation may reduces both dental plaque and risk of developing caries as~     well as contributes to treat gingivitis, periodontitis, peri-implantitis and endodontic~     diseases. The investigators hypothesis was that PDT with blue light and curcumin promotes~     oral disinfection during 2 hours after treatment.~   "
69132|NCT02152462|"~     Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to~     a control group. The investigators will randomize Black sedentary overweight/obese women to~     Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will~     come to the Georgetown community-based exercise facility 3 days/wk. The control group will~     be asked to maintain their current daily activities and not to exercise for the duration of~     the study. Based on the investigators previous findings that women who engage in 75-150~     mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will~     target this level of activity in the investigators intervention arm. Also, this 150 min/week~     of physical activity meets the current recommendations of the American College of Sports~     Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals~     and is in line with recommendation of the American Cancer Society (ACS) for cancer~     prevention.~   "
69133|NCT02152449|"~     The purpose of this study is to determine whether an early oral nutritional supplementation~     (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this~     rapidly progressive disease.~   "
69134|NCT02152436|"~     Communication in the operating room (OR) is a key factor to prevent deleterious events for~     the patient. French national health authority made the implementation of safety checklist~     mandatory in operating rooms. The goal of this checklist is to improve teamwork and share~     key elements for better patient outcomes. Observational studies in the OR showed low~     compliance to this checklist, either on the way it is used or on the information~     implemented.~      The primary objective of this project is to assess the efficacy of a simulation-based~     curriculum involving OR medical and non-medical personnel in order to improve communication~     in the OR.~   "
69135|NCT02152423|"~     Because of their anti-Xa and ease of administration activity, the Low molecular weight~     heparin represent an attractive alternative to the unfractionated heparin. Several clinical~     trials have demonstrated that Low molecular weight heparin was more effective than~     Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the~     most studied. Its use is recommended.~      Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.~   "
69136|NCT02152410|"~     Renal colics are a common cause af acute intense pain in medical emergency settings~     requiring often the use of high level antalgics (opioid) to relief the patient.~      In the other hand, Acupuncture is well known widely for its therapeutic characteristics,~     especially in relieving pain.~      the aim of these study is to compare this two pain relieving techniques in patients~     consulting the emergency departement (ED) for acute onset renal colics.~   "
69137|NCT02152397|"~     Use of opioid medications for treatment of pain has increased greatly in the U.S., with the~     average quantity of prescribed opioids increasing 700% in a decade, from ~100 morphine~     milligram equivalents (MME) per person to ~700 MME per person from 1997 to 2007. There have~     been concurrent increases in opioid-related adverse outcomes, such as extramedical use,~     opioid use disorders, and overdose. As a result, there were more unintentional poisoning~     deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640).~     Additionally, the number of Americans seeking treatment for opioid use disorders has~     increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary~     substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530%~     increase.~      The specific aims of this project are to: (1) Refine a motivational enhancement prevention~     intervention for prescription opioid overdose risk reduction and improved witnessed overdose~     response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized~     controlled trial comparing the prescription opioid overdose prevention intervention to a~     supportive educational control condition for patients in addictions treatment in order to:~     (a) obtain information about the feasibility of randomized controlled procedures; and (b)~     determine the distribution and variability of the primary (overdose risk behaviors) and~     mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk,~     knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the~     distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection~     of prescription opioids) over follow-up.~   "
69138|NCT02152384|"~     This study will look into how a base dose of insulin peglispro and insulin glargine will~     affect the meal time dose and efficacy of insulin lispro in type 1 diabetics. This study is~     expected to last up to 17 weeks.~   "
69139|NCT02152371|"~     The main purpose of this study is to evaluate the use of the study drug known as dulaglutide~     in participants with type II diabetes who are taking once-daily insulin glargine. The study~     will last about 31 weeks for each participant.~   "
69140|NCT02152358|"~     The aim of this study is to show that a preemptive treatment by ganciclovir (for positive~     CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the~     number of ventilator-free days at Day 60.~   "
69141|NCT02152345|"~     The main purpose of this study is to ﬁnd out whether treatment to prevent kidney rejection~     with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will~     result in less delayed graft function or sleepy kidney after transplant than that seen in~     patients who get tacrolimus as their main drug to prevent rejection instead of belatacept.~     The investigators will also look at whether patients who get belatacept have the same,~     lesser or more problems that those who get tacrolimus.~   "
69142|NCT02152332|"~     The purpose of this study is to evaluate the effects of JNJ-54861911 on the QT/QTc intervals~     in healthy participants, when administered at therapeutic (50 milligram [mg] once-daily) and~     supratherapeutic (150 mg once-daily) doses for 7 days.~   "
69143|NCT02152319|"~     The objective is to clinically assess the Kinesia HomeView system for automated and remote~     monitoring of Parkinson's disease (PD) motor symptoms.~   "
69144|NCT02152306|"~     The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in~     hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with~     hypertension who have no response to Fimasartan 60mg monotherapy.~   "
69145|NCT02152293|"~     The purpose of this study is to assess, in real life, the efficacy and the eligibility for~     discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient~     surgery.~   "
69146|NCT02152280|"~     Research topic.~        -  A clinical trial of Danhong injection in treating acute ischemic stroke .~      Research purpose.~      - To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke~     by a randomized, double-blind, multi-center, placebo-controlled clinical trial.~      Research design.~      - A randomized, double-blind, multi-center, placebo-controlled clinical trial.~      Subject crowd.~      - Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke~     and blood stasis type of traditional Chinese medicine syndrome differentiation.~      Sample size. - Total sample size of 320 patients, experimental group, control group is equal~     to 1 to 1.~      Interim analysis.~      - Interim analysis will be performed when the total number of included patients up to half~     of the sample size ,160 cases, and according to the interim analysis results to estimate the~     sample size and adjust the project adaptively.~      Course of treatment.~      - 10 days.~      Research endpoint.~      - The 90th day after the medication for the first time.~      Observation index.~        1. General condition; the physical and chemical inspection related;~        2. Efficacy check : mRS, BI, NIHSS;~        3. Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal~          function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.~      Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group~     patients of modified Rankin 0-2 grades on the 90th day.~      Statistical analysis technique.~      - Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral~     inspection, P value less than or equal to 0.05 will be considered a statistically~     significant difference.~   "
69147|NCT02152267|"~     1. BACKGROUND: Temporomandibular Disorders (TMD) have become part of the daily routine of~          all the health care professionals. Some studies have shown improvement in subjects with~          chronic pain using neuromodulation. Chronic pain is involved with neuronal excitability~          and the excitatory modulation is also being studied to treat chronic pain. Transcranial~          direct current stimulation (tDCS) allows the neuronal membranes to be neuromodulated.~          tDCS can enhance or inhibit the potential actions on the cortex. Studies with animals~          has shown that anodal stimulation modulate the membrane in the way to depolarize which~          results in a long term potential in the stimulated area.~        2. PROBLEM: Most strategies for the treatment of TMDs are local and aim to treat directly~          the cranial-facial muscles, applying kinesitherapy on Temporomandibular joint (TMJ)~          and/or on the jaws and on the occlusion of teeth. Some drugs, such as tricyclic~          antidepressants, that act in the CNS are used in these patients with positive results~          in the beginning of the treatment. However, many patients after using these drugs in a~          daily basis, are refractory to them and do not present an improvement in the pain~          anymore or present several side-effects. Therefore, the investigators want to know if~          tDCS over dorsolateral prefrontal cortex (DLPFC) would have an analgesic effect when~          reaching emotional areas.~        3. HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would~          decrease the anxiety level and consequently the muscular hyperactivity that is an~          important etiological factor of TMD. For that, the masseter motor evoked potential~          (MEP) will be used to verify any change.~        4. AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects~          with muscular TMD.~        5. METHOD: The investigators will run a three-arm crossover double blind with 15 muscular~          TMD subjects. The group treatments will be cathodal tDCS 1mA, cathodal tDCS 2mA and~          Placebo. To verify selection criteria the investigators will use RDC/TMD, Visual~          analogical scale (VAS) score from 4 to 10 for six months or longer, Inventory of~          state-trit anxiety (ISTA) score more than 42. The outcomes will be VAS, sensory~          testing, Electroencephalogram (EEG) and ISTA.~   "
69148|NCT02152254|"~     The goal of this research study is to compare the effects of treatment based on molecular~     profiling to those of the standard-of-care.~      Treatment Assignment:~      From a tumor biopsy, a molecular profile of the disease is established. Based on genetic~     profiling, the following interventions will follow:~      A) If there is no abnormality, patients will be treated according to the patient's doctor as~     to what is in their best interest.~      B) If there is an abnormality and there is an FDA-approved drug for the tumor type, patients~     will be offered that treatment.~      C) If there is an abnormality and there is no FDA-approved drug for the abnormality and the~     tumor type, patients will be randomly assigned to Arm A (targeted therapy) or Arm B~     (standard-of-care therapy).~   "
69149|NCT02152241|"~     Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a~     chronic course with remission and relapses. Canada is one of the countries with the highest~     prevalence and incidence rates of IBD with 25% of patients present in children and~     adolescents.~      As with any chronic illness, IBD diagnosed early in life has a significant impact on the~     physical, emotional and social development of those affected. Consequently, it is logical to~     speculate that patients with IBD may not do as well in education levels or employment status~     attained compared to their peers without IBD. If this were the case, then interventions~     could begin in childhood to better prepare patients with IBD for the challenges of living~     with a chronic disease. Alternatively, if it is shown that they reach comparable social or~     employment milestones as adults compared to unaffected peers then this would be enormously~     reassuring to children and their parents.~      Properly designed studies to help in defining more appropriate interventions to these~     patients are needed.~      The proposed study includes circulating a survey to evaluate the functioning level of adult~     patients with IBD who were diagnosed during their childhood. The participants will be asked~     a series of questions regarding their highest level of educational achievement, the nature~     of their current employment, and their current marital status. The question format will~     parallel that of the Canadian Community Health Survey from which data from an age matched~     healthy adult Manitobans will be extracted and used as another control group. Responses will~     be analysed for any possible differences between these groups.~   "
69152|NCT02152202|"~     Our main objective is to perform an explanatory, first stage proof of concept, randomized~     controlled trial to determine whether a semi-upright patient position versus a supine~     position while asleep in the postoperative period helps decrease the worsening of AHI in~     patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning~     while asleep).~      The investigators will evaluate whether a semi-upright position reduces: worsening of AHI~     (as measured with a portable PSG) on the second postoperative night (POD2); oxygen~     desaturation index (using a portable oxygen saturation monitor, oxygen desaturation defined~     as >4% change below baseline lasting for 10 seconds); REM sleep related change in AHI at~     baseline and POD2.; major and minor perioperative complications on postoperative day POD1,~     POD2, at discharge and POD 30.; length of hospital stay and readmission within 30 days; and~     patient satisfaction score on POD30~   "
69153|NCT02152189|"~     The purpose of this study is to assess the frequency of Fabry disease in children with~     chronic abdominal pain or chronic pain in the extremities~   "
69154|NCT02152176|"~     Intense acute pain is a common reason for Emergency admittance and its management is one of~     the major public health goals.~      In the recommendations formalized experts, it is recommended to use a protocol titration~     with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg)~     repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.~      Despite these specific recommendations and a broad awareness of the teams, management of~     pain remains to be improved, the major difficulty of morphine titration at the emergency~     department being the availability of paramedical personnel to perform revaluations and~     reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.~      The investigators want to study the self-controlled morphine titration by the patient by a~     mechanical device for single use (efficacy/safety).~   "
69155|NCT02152163|"~     STUDY OBJECTIVES:~        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in~          decreasing pain in orthopedic trauma patients with fractures of the extremities, face,~          pelvis and/or ribs compared to patients not receiving the medication.~        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in~          decreasing the use of opioid analgesics among orthopedic trauma patients with fractures~          of the extremities, face, pelvis, and/or ribs compared to compared to patients not~          receiving the medication.~   "
69156|NCT02152150|"~     The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet~     in improving iron status in adolescents in India.~   "
69157|NCT02152137|"~     This phase II trial studies how well inolitazone dihydrochloride (efatutazone~     dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer~     that has spread to other places in the body and usually cannot be cured or controlled with~     treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
69158|NCT02152124|"~     Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the~     vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone~     (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both~     the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or~     pegvisomant affect glucose and lipid metabolism, possibly contributing to increased~     cardiovascular risk.~      In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut~     hormone response, lipid handling and adipocytokine profile in the following 4 groups:~        -  controlled acromegalic patients on LA-SMSA (group 1)~        -  controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant~          (group 2)~        -  acromegalic patients without need for medical therapy after surgery (group 3)~        -  healthy control subjects (group 4)~      Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic~     patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or~     symptoms due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy~     (group 5). In this group, insulin sensitivity, postprandial gut hormone response, lipid~     handling and adipocytokine profile will be explored before introducing pegvisomant and three~     months after normalisation of IGF-1 levels.~      The investigators hypothesize that lipid and glucose handling will be less efficient in the~     controlled acromegalic patients on LA-SMSA than in controlled patients on combination~     therapy or after surgery, and that there will be no difference in substrate metabolism~     between healthy controls and controlled acromegalic patients on combination treatment or~     after surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled~     acromegalic patients will improve their postprandial lipid and glucose handling.~   "
69159|NCT02152111|"~     This study aimed to evaluate the effect of weight loss with diet combined coconut flour~     consumption improvement weight loss and reduction in glucose, cholesterol in obese women.~   "
69160|NCT02152098|"~     Firstly, the investigators aim to study the biochemical, structural and functional changes~     associated with acute muscle strain injury in the acute phase and during rehabilitation in~     vivo. Specific factors present after the injury and their effects on connective tissue cells~     will be examined in vitro.~      Secondly, the investigators will investigate individuals with chronic pain, scar tissue and~     inferior function after a previous muscle strain injury and test a specific rehabilitation~     program to alleviate pain and disabilities associated with the preceding muscle injury. The~     investigators have the following hypotheses:~        1. Humoral growth factors and pro-inflammatory macrophages released into the injured area~          post strain injury stimulate formation of connective tissue in vitro.~        2. Early onset of rehabilitation will be superior to a delayed start of rehabilitation for~          the healing process, in regards to structural improvement of tissue and better clinical~          function.~        3. Scar tissue following a muscle strain injury is characterized by disorganized structure~          of connective tissue.~        4. Mechanical loading in the form of heavy eccentric muscle activity for 12 weeks will~          lead to a local re-modeling of scar tissue, and result in improved function and reduced~          symptoms in patients with chronic pain and impaired function after a previous muscle~          injury.~   "
69161|NCT02152085|"~     The purpose of this study is to investigate the capacity of a 6-week treatment with~     neuromuscular electrical stimulation to improve walking in individuals whose mobility has~     been compromised by multiple sclerosis.~   "
69183|NCT02151799|"~     The data regarding the effects of aesthetic body contouring is insufficient. Poor results~     may related to preoperative psychological distress. Studies regarding eating disorder~     symptoms are lacking. Therefore studies using standardized and validated are needed. We~     decided to prospectively study quality of life, psychological distress, and eating disorder~     symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used~     questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and~     the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery~     has notable quality of life effects.~   "
69162|NCT02152072|"~     Dyspnea is a common symptom encountered frequently by medical practitioners. The~     differential diagnosis for a patient with such a symptom is broad and time consuming, while~     immediate management for distressed patients is what is desired. Lung ultrasound (LUS) is a~     relatively new technique that will help physicians more accurately diagnose and manage~     patients who present with dyspnea.~      Focused medical ultrasonography education is becoming integrated into many physician~     residency training programs. Recent studies indicate a possible relationship between focused~     ultrasonography training in medical school curricula and improved physical examination~     accuracy. Thus, a short-term training program in LUS during medical school will have a major~     impact on physicians to be comfortable in using this skill when dealing with distressed~     patients in their prospective residency training. It will reduce educational burdens for~     physician residency programs and improve overall physician competency.~      Simulation-based medical education (SBME) is ideally suited for offering effective training~     in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing~     with stressful clinical scenarios without exposing patients to any additional risk. SBME has~     also been shown to be a reliable tool for assessing learners' procedural skills and for~     teaching topics such as teamwork and communication.~      The investigators hypothesize that simulation-based training of medical students will enable~     them to more effectively evaluate patients with shortness of breath using LUS.~   "
69163|NCT02152059|"~     This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent,~     platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be~     more effective and better tolerated than standard therapy.~      The purpose of this study is to:~        -  Find out the proportion of patients with their small small cell lung cancer controlled~          for at least 90 days after treatment with BIBF1120~        -  Compare the response rate, survival and side effects of BIBF1120 in recurrent,~          platinum-sensitive small cell lung cancer patients~        -  Identify a group of patients who will benefit the most from BIBF1120 In this study,~          patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21~          days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if~          patients do not tolerate it well or if the doctors are concerned about the side effects~          of BIBF1120 on individual patients.~   "
69164|NCT02152046|"~     Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular~     examinations of infants at risk for ROP are generally conducted between 4-6 weeks~     postnatally. These exams are vital to protect preterm infants from blindness, but these~     exams have been shown to cause pain in this population.~      Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook~     eyelid speculum. There is no schedule for who receives which speculum during their exam.~      The objective of this study is to evaluate the pain response in the neonatal population, 32~     weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for~     retinopathy of prematurity (ROP) screening.~      The primary study aim is to compare the N-PASS pain score between neonates who received a~     ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.~   "
69165|NCT02152033|"~     The purpose of this project is to develop and test a Home-based Continuing Care intervention~     that will help parents support the recovery of their Young Adult (YA) child who is leaving~     residential substance abuse treatment. The two phase pilot study will 1) interview 50~     parents and 50 YAs recruited from residential treatment programs and from parent groups to~     inform the development of the intervention and 2) conduct a two-arm pilot study that will~     recruit a maximum of 20 parents and their young adult children into one of two conditions~     (Home-based Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison~     group) with the main goal of determining whether conducting such an intervention is~     acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that~     pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b)~     conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from~     HCC will be clinically meaningful.~   "
69166|NCT02152020|"~     The objective of this study is to find out if acupuncture can improve the management of pain~     in cancer patients when used as part of a treatment plan that includes conventional pain~     medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and~     Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain~     Management group or Integrative Pain Management group.~   "
69167|NCT02152007|"~     A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in~     adults with PC. Subjects may receive either placebo or treatment with at least 1 foot~     receiving topical sirolimus at some time. For certain phases of the study treatment~     assignment to the right and left foot will be randomized in a double blind fashion. Blood~     levels will test systemic absorption of sirolimus. Other safety and efficacy measures will~     be taken through the 39-week study duration. Funding Source - FDA OOPD~   "
69168|NCT02151994|"~     The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after~     single and multiple oral doses~   "
69169|NCT02151981|"~     A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet~     Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer~     whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth~     Factor Receptor Gene~   "
69170|NCT02151968|"~     Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block.~     This is a blind technique where local anaesthetic is injected into the back of the eye to~     make the eye numb and motionless for surgery. This is a blind injection and can be~     associated with complications such as bleeding, rupture of eye globe, blindness, increasing~     the pressure of the eye etc. It also has a high failure rate resulting in need for~     additional injections, further exposing the patient to possible complications. The~     investigators propose to perform the peribulbar block with ultrasound to guide the block~     needle placement and injection. The investigators hypothesize that ultrasound guided~     peribulbar blocks would have higher success rate (less need for additional injections) and~     that the total amount of local anaesthetics used would be decreased.~   "
70996|NCT02128074|"~     The objective of this pilot study is to evaluate the efficacy and safety of KRX-0502,~     administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5~     non-dialysis dependent chronic kidney disease (NDD-CKD).~   "
69171|NCT02151955|"~     Following an exploratory project, funded by Guys and St Thomas' Charity between September~     2010- November 2011, of the first combined mental health screening and intervention project~     for <5 Children in Care (CiC) in the UK, the current study will expand this work by a)~     developing a feasibility study to assess both longer term interventions and outcomes for~     this group and b) extending the model to two further vulnerable groups of young children.~      The three groups of children aged 3 months to 3 years (<4's) in Southwark include:~        1. Children who become newly looked after (CiC)~        2. Children of parents referred to Parental Mental Health team (PMH)~        3. Children on Child Protection (CP) Plans~      Parents will be invited to take part in the study if their children are eligible within the~     groups above. Informed consent will be obtained at the outset.~      Hypothesis;~      The investigators aim to implement a method of screening that will identify socioemotional~     and mental health needs in infants and young children, aged 0-3 years of age, across three~     high risk cohorts (Children in Care, children on a Child Protection Plan, children of~     parents with mental health difficulties).~      Is it feasible to deliver an early treatment intervention that positively impacts on the~     difficulties identified, by providing specific emotional, social and mental health support~     and advice to the child's current caregivers in relation to the child.~   "
69172|NCT02151942|"~     The purpose of this study is to evaluate the procedural and clinical benefits of patient~     specific pre-procedure rehearsal for operators with various experience levels as a tool for~     optimizing Endovascular Aneurysm Repair (EVAR) procedures.~   "
69173|NCT02151929|"~     Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient~     treated with primary PCI (pPCI).~   "
69174|NCT02151916|"~     The purpose of this study is to determine whether a combination of pre- and post-natal~     preventive and behavioral interventions is effective in preventing early childhood caries in~     Indigenous children.~      Early childhood caries (ECC) causes profound suffering, frequently requiring expensive~     treatment under a general anesthetic. It is associated with other chronic childhood~     conditions such as otitis media and nutritional disorders, and is the strongest predictor of~     poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC~     disparities exist between Indigenous and non-Indigenous children in Australia, New Zealand~     and Canada. If the burden of ECC and associated oral health inequalities experienced by~     Indigenous children in these nations are to be reduced, more needs to be done to ensure that~     appropriate preventive measures, together with support for maintaining optimal oral health,~     are provided to caregivers of such children in the early life stages. This will be an~     interventional study, with all participants receiving the intervention benefits. Pregnant~     Indigenous women residing in the three countries, their families and communities will be~     included. The intervention will be implemented from birth and continue for the first three~     years of a participating child's life. It will involve four components; dental care provided~     to the mother during pregnancy, fluoride varnish applications for the child, oral health~     anticipatory guidance and motivational interviewing. Following an Indigenous research~     framework and methodology, the intervention will be tailored at the individual- or~     family-level, with each caregiver or family progressing to the next level only when they are~     ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral~     health, in full partnership with the Indigenous communities involved, will provide much~     needed evidence for policy makers to address the challenge of improved oral health and~     related outcomes for Indigenous children.~   "
69175|NCT02151903|"~     An open-label extension study enrolling patients experiencing clinical benefit following 6~     cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology AO-101 study. Patients will be~     permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of~     administration they received while on the parent protocol. Prior pre-treatment (e.g.~     Rituximab) will continue as before.~   "
69176|NCT02151890|"~     Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established~     in 10 cases.~      ESS cut off point for menstruation and pregnancy was 6.~   "
69177|NCT02151877|"~     Around 7500 neonates born yearly in the United States have complex congenital heart disease~     that require surgical repair in the first few days of life. The complexity of the surgical~     repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent~     periods of low flow or complete circulatory arrest. The immature neonatal vital organs are~     more prone to the complications of the cardiopulmonary bypass circulation, namely~     ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide~     (NO) is used frequently in neonates for the treatment of pulmonary hypertension,~     Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing~     I/R injury and endothelial dysfunction.~      The purpose of this pilot study is to assess the efficacy of NO administration via the CPB~     circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in~     neonates undergoing repair of complex congenital heart defects. Specific goals will be to~     demonstrate that NO use via CPB will:~        -  Decrease markers of I/R injury and systemic inflammatory response.~        -  Decrease platelet activation leading to reduced postoperative bleeding and transfusion~          requirements.~        -  Decrease postoperative organ dysfunction, and hence decrease operative mortality and~          postoperative morbidity.~      Twelve neonates undergoing repair of complex congenital heart defects will receive NO via~     the CPB circuit, for the duration of surgery. They will be compared to a control group of 12~     similar patients. Serum levels of different ischemic reperfusion injury and inflammatory~     markers will be measured at different time points after surgery and will be correlated with~     different end organ function tests and clinical course in the postoperative period. The~     results will be compared between the two groups to try to determine the clinical benefit of~     NO administration through CPB circuit.~   "
69178|NCT02151864|"~     The purpose of this study is to test the safety and determine the maximum safe dose of an~     experimental drug called LDE225 (hedgehog inhibitor) in people with liver cancer. We have~     identified hedgehog dysregulation as a novel mechanism for hepatocarcinogenesis and hepatic~     fibrosis/cirrhosis. Therefore, we hypothesize that the hedgehog inhibitor may be an ideal~     drug target for treating both hepatocellular carcinoma (HCC) and Child-Pugh A cirrhosis~     (CPA).~   "
69179|NCT02151851|"~     This study will evaluate the safety & efficacy of Certolizumab Pegol (CZP) as additional~     medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients~     will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the~     study is about 32 weeks.~   "
69180|NCT02151838|"~     To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for~     the Prevention of Mother-To-Child Transmission of HIV (PMTCT)~   "
69181|NCT02151825|"~     The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the~     gut microbiota composition, body composition and adiposity-related genes and metabolic~     markers in healthy overweight adult subjects.~   "
69182|NCT02151812|"~     The primary objective of this study is determine the safety and performance of the Agent™~     Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing~     Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented~     coronary arteries (in-stent restenosis).~      The performance will be determined at six months post-procedure by quantitative coronary~     angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA~     results will be assessed by an independent, blinded angiographic core lab.~      Study statistical hypothesis: The loss of in-stent luminal diameter at six months after~     treatment of the restenosed stent with the Agent™ study device is not larger than the~     respective LLL after treatment with the SeQuent® Please control devices, i.e. study device~     is non-inferior to the control device with respect to LLL.~   "
69185|NCT02151773|"~     The purpose of this survey is to assess the safety freeze-dried live attenuated measles and~     rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated~     measles and rubella combined vaccine Takeda) in terms of the occurrence of unknown/known~     adverse drug reactions and factors that may influence the safety of vaccinees after the~     first vaccination.~   "
69186|NCT02151760|"~     This study is being done to determine the safety, biodistribution, and radiation dosimetry~     of 18F-DCFPyL, and to detect prostate cancer by visual analysis.~   "
69187|NCT02151747|"~     Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger~     sequencing is a standard method to identify BRCA 1/2 mutation. Next generation sequencing~     (NGS) is a high-throughput parallel sequencing that can provide genetic information with~     high accuracy. NGS is a faster and cost-effective method to detect gene mutations compared~     to Sanger sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA~     1/2 compared to Sanger sequencing.~   "
69188|NCT02151734|"~     This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel~     group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in~     patients with acute bronchitis.~      The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically~     non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the~     treatment of acute bronchitis after 7 days.~   "
69189|NCT02151721|"~     -  Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase~          inhibitor (EGFR-TKI). However, 20-30% of patients with EGFR-activating mutations show~          intrinsic resistance to EGFR-TKI.~        -  EGFR-mutant non-small cell lung cancer (NSCLC) cells with BIM (BCL2L11) deletion~          polymorphism show the impaired generation of BIM with the proapoptotic BH3 domain, as~          well as resistance to EGFR-TKI-induced apoptosis.~        -  Both BIM polymorphism (12.9%) and EGFR mutations (50% in lung adenocarcinoma) are more~          prevalent in the East Asian than in Caucasian populations. BIM is a BH3-only~          proapoptotic member of the Bcl-2 protein family. BIM upregulation is required for~          apoptosis induction by EGFR-TKI in EGFR-mutant NSCLC.~        -  Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule inhibitor of~          histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest, and~          apoptosis in several tumor cells. HDAC inhibition can epigenetically restore BIM~          function and death sensitivity of EGFR-TKI in patients with EGFR-mutant NSCLC in whom~          resistance to EGFR-TKI is associated with a common BIM polymorphism. EGFR-TKI~          resistance due to the BIM polymorphism may be able to be circumvented in combination~          with HDAC inhibition of vorinostat with gefitinib in NSCLC.~   "
69190|NCT02151708|"~     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper~     abdominal pain or discomfort in the absence of a specific structural cause.1 Several~     mechanisms have been suggested to underlie dyspeptic symptoms. In a barostat study by Tack~     et al.2, impaired gastric accommodation to a meal was found in 40% of patients with FD, and~     this abnormality was associated with early satiety. Delayed gastric emptying (GE) was also~     found in almost 40% of patients with FD, and was associated with the symptoms of~     postprandial fullness, vomiting and early satiety.3-5 Improving gastric accommodation and~     prokinetic effect seem to be an attractive physiological target in patients with FD.~     Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December~     2011 in Korea for treating patients with FD. It has multiple mechanisms of action such as~     fundus relaxation, visceral analgesia and prokinetic effects.6 The current study aims to~     evaluate effects of motilitone on gastric emptying and accommodation after a meal in~     patients with FD using three-dimensional gastric volume measurements by magnetic resonance~     imaging (MRI). Patients are randomly allocated to receive either motilitone 90 mg daily,~     motilitone 180 mg daily or placebo in a double blinded manner. After 2 weeks of treatment,~     patients undergo gastric MRI. The primary endpoint is gastric emptying rate. The secondary~     endpoints are gastric accommodation and symptom improvement.~   "
69191|NCT02151695|"~     Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly~     consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of~     retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency~     for treatment of exudative age-related macular degeneration, another retinal disease~     characterized by choroidal new vessels.~      The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept~     intravitreal injections compared to panretinal photocoagulation for proliferative diabetic~     retinopathy.~   "
69192|NCT02151682|"~     Tapentadol has already been studied in adults. This study is needed to find out if~     tapentadol works and is safe to use in children and adolescents with long-term pain.~      During the first 2 weeks of the study (Part 1), participants will be given either tapentadol~     or morphine prolonged-release tablets. Assignment will be done randomly (like tossing a~     coin). The participant and the caregiver will know which medication they are taking. The~     primary endpoint is based on data collected in Part 1 of this trial.~      If eligible and willing, participants from Part 1 can enter a 12 month follow-up period~     (Part 2). In Part 2 of this trial participants will be treated with tapentadol prolonged~     release tablets or with the standard of care (observation arm).~   "
69193|NCT02151669|"~     Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover,~     no previous studies have prospectively evaluated the effect of the Mediterranean dietary~     pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to~     evaluate the efficacy of a motivational smoking intervention based on information obtained~     by spirometry (FIS project PI11/01962).~   "
69194|NCT02151656|"~     The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison~     to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design:~     double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design,~     multicentre study.~   "
69195|NCT02151643|"~     The main purpose of this study is to see whether PT-20 can help people with a high level of~     phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for~     kidney disease.~   "
69814|NCT02143570|"~     Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic~     drug that is frequently used as part of the management of the condition. However, current~     evidence backing its use is limited. This study aims to address Darifenacin's effectiveness~     in adjunct to physiotherapy in treating symptoms due to overactive bladder.~   "
69196|NCT02151630|"~     Plantar warts can be bothersome and painful requiring treatment. The investigators will~     compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts.~     Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70%~     or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion~     100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for~     one month after starting treatment and then every one month for up to 3 months. The number~     and size of warts will be evaluated.~   "
69197|NCT02151617|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time~     course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic~     activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will~     also be investigated.~   "
69198|NCT02151604|"~     Lung cancer is the second most commonly diagnosed cancer in the United Kingdom, accounting~     for 22% of cancer deaths. The main treatments for lung cancer are surgery, radiotherapy or~     chemoradiotherapy. Current methods, for assessing lung function in lung cancer patients i.e.~     spirometry and gas transfer are inadequate. We aim to develop a new technique capable of~     describing regional lung abnormality using hyperpolarized xenon gas MRI.~      The study will involve 50 patients diagnosed with lung cancer considered suitable for~     radical radiotherapy or chemoradiotherapy. Participants will be offered hyperpolarized Xe129~     MR at baseline, two weeks after commencement of radiotherapy schedules and four followup~     visits over one year posttreatment.~      Patients will undertake extensive study measures at baseline and followup visits, including~     chest CT scans, ventilation/perfusion nuclear medicine scans, gadolinium enhanced MRI scans,~     pulmonary function tests, breathlessness scores, radiotherapy induced lung toxicity~     assessments and exercise testing. Participation in these full tests takes a day, allowing~     patients time to rest between tests and allowing for a period of observation following the~     final hyperpolarized xenon scan.~      The investigators will correlate baseline hyperpolarized Xe129 MR imaging with spirometry~     and breathlessness scores to determine if tolerance for radiotherapy is better predicted by~     hyperpolarized Xe129 MR imaging. The investigators will evaluate changes in hyperpolarized~     Xe129 MR imaging before and after radiotherapy (RT) to determine if it provides better~     monitoring of response compared with spirometry.~      The study will take place at the Churchill Hospital, Oxford University Hospitals National~     Health Service Trust and will be funded by the National Institute for Health Research Oxford~     Biomedical Research Centre. Hyperpolarized Xe129 MR imaging has the potential to inform~     individual suitability for radiotherapy schedules better than the investigations used~     currently. In addition, hyperpolarized Xe129 MR imaging has the potential for better~     monitoring of treatment response and improved detection of radiation induced lung injury,~     invaluable to treating patients with radiation induced injury.~   "
69199|NCT02151591|"~     The purpose of this study is to develop and test an integrated cognitive-behavioral~     intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot~     phase will be used to refine this protocol for the subsequent randomized, controlled pilot~     phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a~     12-week treatment phase in which participants receive varenicline (Chantix) and weekly,~     personalized counseling.~   "
69200|NCT02151578|"~     A well-implemented community-based program of early and appropriate treatment of~     fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction~     of the less than five mortality rate.~   "
69201|NCT02151565|"~     Sciatica is a common pain problem that affects not only the patient but also constitutes a~     socioeconomic burden and thus affects the whole society. So far, current pharmacologic~     therapies are inadequate for many patients. Therefore, we evaluated application of high-tone~     external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation~     (TENS) on radicular pain associated with sciatica.~   "
69202|NCT02151552|"~     The purpose of this study is to learn more about the basic responses of the lungs to~     inflammation using positron emission tomography, or PET, imaging scans of the lungs. PET is~     a machine that detects radiation and generates pictures using a donut-shaped scanner similar~     in appearance to an x-ray CAT or computed tomography (CT) scan or an MRI. Inflammation is~     the way our bodies react to irritation or injury, and involves red, warm, and often painful~     swelling of the affected tissue. An enzyme called inducible nitric oxide synthase (iNOS)~     contributes to the development of lung inflammation.~   "
69203|NCT02151539|"~     This research trial studies medical chart review in determining outcomes of second-line~     therapy in patients with acute graft-versus-host disease previously treated with~     extracorporeal photopheresis or other systemic therapies. Gathering information about~     second-line therapy in patients with acute graft-versus-host disease may help doctors learn~     more about the disease and find better treatment.~   "
69204|NCT02151526|"~     This is a Phase 1/2, open label, safety, and efficacy study of the administration of~     LentiGlobin BB305 Drug Product to subjects with either beta-thalassemia major or severe~     sickle cell disease (SCD).~   "
69205|NCT02151513|"~     The purpose of this study is to examine the changes in immune function, as measured by~     biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid~     medications for the treatment of moderate to severe cancer pain.~      Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little~     alteration of immune function as measured by biomarkers in the blood of cancer patients with~     moderate to severe pain.~   "
69206|NCT02151500|"~     The goal of this study is to test the feasibility and acceptability of providing an~     experiential assessment interview that targets emotional and stressful experiences in~     primary care. In this randomized, controlled trial, the investigators will compare an~     interview condition to a wait-list control condition. The investigators hypothesize that~     helping individuals first identify the links between their stress and symptoms will likely~     increase their awareness and endorsement of the link between stress and physical symptoms,~     including a willingness to engage in stress management techniques. It is also expected that~     helping raise an individual's awareness about their symptoms, followed by an experience and~     expression of unexpressed emotions is likely to influence their physical symptoms and~     psychological status.~   "
69207|NCT02151487|"~     The aim of this randomized, observer-blinded clinical trial is to evaluate the anesthetic~     and analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in~     supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone~     and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular~     nerve block compared with ropivacaine alone.~   "
69208|NCT02151474|"~     The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986,~     in subjects with moderate to severe rheumatoid arthritis.~   "
69209|NCT02151461|"~     The goal of this study is to demonstrate that leucine in combination with a low does of~     metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in~     type 2 diabetic subjects. This study will compare three doses of a leucine-metformin~     combination to the standard metformin dose in controlling blood glucose levels in type 2~     diabetic patients.~   "
69210|NCT02151448|"~     This trial is to determine the safest dose of a triple combination (chemokine modulatory~     regimen or CKM) of celecoxib, interferon alfa (IFN), and rintatolimod that can be given with~     a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.~      The first phase of this study will determine the safest dose of IFN that can be given in~     combination with celecoxib and rintatolimod along with a DC vaccine. The doses of celecoxib~     (400 mg) and rintatolimod (200 mg) will be consistent while the dose of IFN will be~     increased (5, 10, or 20 MU/m2) as participants are enrolled to the trial. The high dose of~     IFN in combination with celecoxib and rintatolimod will be used for the next phase of the~     clinical trial. After surgery, participants will receive 2 cycles of the investigational~     treatment.~      The second phase of this study will test if the investigational treatment has any effects on~     peritoneal surface malignancies. The doses of the combination determined in the first phase~     will be used in this phase of the clinical trial. After surgery, participants will receive 2~     cycles of the investigational treatment, followed by standard chemotherapy as determined by~     their oncologist, and then 2 more cycles of the investigational treatment.~   "
69211|NCT02151435|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung.~     The estimated prevalence is 30-80/100,000 in the United States with incidence estimates~     clearly rising. A major challenge in the care of patients with IPF is determining prognosis.~     The natural history of IPF is usually one of inexorable decline in lung function, ultimately~     resulting in death from respiratory failure. However, longitudinal physiologic decline in~     IPF is heterogeneous and difficult to predict in individual patients. While some patients~     with IPF may remain stable for years, in others the disease may progress rapidly over a~     relatively short time. We hypothesize that peripheral blood biomarkers based on~     extracellular matrix and matrix-modifying molecules will improve prognostication in patients~     with IPF.~   "
69212|NCT02151422|"~     Despite the advances in pharmacological therapy for asthma, there has been an increasing~     worldwide interest in alternative therapies for asthma. Treatments and therapies such as~     yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been~     used as complementary therapies however little evidence exists behind such practices.~      Data from systemic reviews and randomized control trials provide evidence of benefit~     although additional confirmation is still needed. Among the most common techniques are the~     Buteyko breathing exercises that aim to reduce minute ventilation by instruct asthmatics~     patients to breathe shallowly and slowly through the nose. The second common technique is~     the Pranayama, or yoga breathing exercises which emphasizes deep respirations and exhalation~     prolongation.~      Our goal is to assess the effectiveness of breathing exercises as a complementary therapy~     for asthma.~   "
69213|NCT02151409|"~     This trial is conducted in Europe. The aim of this trial is to develop a complement system~     targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic~     autoimmune diseases.~   "
69214|NCT02151396|"~     There is evidence both that computer-administered cognitive training can improve ADHD~     working memory deficits and that this type of training in non-ADHD enhances normal working~     memory ability by altering brain activity in prefrontal cortex and the parietal lobe.~     However, no study has characterized brain activity changes following working memory training~     in ADHD to understand what neural changes occur when cognitive deficits are remedied. This~     R21 exploratory study will examine the neural basis of cognitive training treatment gains in~     working memory, ADHD symptoms, and various other executive abilities. We will test the~     hypothesis that working memory training increases frontoparietal brain activation and~     examine other regions to see if there is any evidence for neural compensation (i.e.,~     engagement of brain regions after training that are not normally recruited for task~     performance).~   "
69215|NCT02151383|"~     The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of an~     intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients~     with acute heart failure (AHF)~   "
69216|NCT02151370|"~     This observational study will collect data about safety in female patients with advanced~     ovarian epithelial cancer with measurable residual disease after surger y. The treating~     physician has decided to treat the patients with Avastin (bevaci zumab) in combination with~     chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be~     collected for 72 weeks.~   "
69217|NCT02151357|"~     -  Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients~          with advanced solid tumor~        -  Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.~        -  Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR)~          defined as the proportion of patients who continuously receive treatment after Cycle 1~          with a best overall response of complete response (CR) or partial response (PR).~   "
69218|NCT02151344|"~     H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose~     of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca~     influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying~     intervals.~   "
69219|NCT02151331|"~     The overarching goal of this study is to build the most cost-effective adaptive~     implementation intervention involving a site-level implementation intervention strategy:~     Replicating Effective Programs (REP), and the augmentation of REP using either External~     Facilitation or a combination of an External and Internal Facilitation to improve patient~     outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in~     community settings.~   "
69220|NCT02151318|"~     In this study, the investigators will collect tissue from patients undergoing trabeculectomy~     for primary open-angle glaucoma treatment. This tissue would normally be discarded. These~     trabecular meshwork (TM) cells can be cultured and used experimentally to better understand~     the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the~     trabeculectomy using established techniques.~   "
69221|NCT02151305|"~     We investigated the hemostatic differences according to the main anesthetic agents by~     analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based~     anesthesia would impair postoperative coagulability more than the sevoflurane-based~     anesthesia.~   "
71033|NCT02127593|"~     The purpose of this study is to establish the bioequivalence of the hormones norgestimate,~     norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets,~     formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by~     dry process, in healthy women.~   "
69222|NCT02151279|"~     Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods,~     has been used as a fining agent in wines. However, its safety among patients allergic to~     shellfish has never been evaluated.~      Adult patients followed at the Allergy and Clinical Immunology Department who have been~     diagnosed with anaphylaxis to shrimp will be invited to participate in the study.~      Clinical data will be collected to ascertain for eligibility and written information will be~     provided. After signing informed consent, included subjects will perform skin prick-to-prick~     tests (PTP) with shrimp boiling water condensate and with fined and unfined wines. All will~     perform double blind oral challenge with the fined and unfined wines during 1visit day; the~     placebo (unfined wine) and active challenge (fined wine with chitosan) will be separated by~     2 hours. Challenge protocol will be performed with successive increasing doses administered~     in 4 steps at 15-minute intervals for a total of 100 mL. During the challenge signs and~     symptoms will be monitored by a trained physician.~      Results will be presented as negative or positive (defined by presence of symptoms and signs~     of an allergic reaction).~      Categorical data will be compared by chi-square test. P<0.05 will be considered~     statistically significant.~   "
69223|NCT02151266|"~     Cognitive impairment (CI) is a prevalent problem in persons with HF heart failure (HF) and~     is associated with adverse clinical outcomes, higher mortality and poorer quality of life.~     Studies designed to attenuate or alleviate CI in persons with HF are limited, and evidenced~     based guidelines for screening and provision of care are practically nonexistent.~     Improvement in cognition has been reported following some therapies in HF and is thought to~     be the consequence of enhanced cerebral perfusion and oxygenation, suggesting that CI may be~     amenable to intervention in this population. Exercise is documented to increase cerebral~     perfusion and oxygenation by promoting neuroplasticity and neurogenesis, and, in turn,~     cognitive functioning. Brain derived neurotrophic factor (BDNF) is a key mechanism~     underlying the effect of exercise, but most studies of BDNF have not included individuals~     with CI or chronic illness populations, and its relationship to cognitive outcomes in HF is~     unknown. Cognitive retraining techniques, originally developed to treat traumatic brain~     injury, have also shown efficacy in broader neurologically-affected conditions and may~     provide added benefit to that of exercise. Animal studies suggest exercise and~     plasticity-based cognitive training could act synergistically through different neural~     mechanisms to have a more pronounced and positive impact on cognitive outcomes than either~     approach alone; but this has not been previously tested as an intervention to improve CI.~     The proposed feasibility study is designed to test the acceptability and limited efficacy of~     a combined exercise (Ex) and cognitive training (CT) program to improve CI in stable NYHA~     class II and III HF patients compared to either exercise alone or a no-intervention,~     attention-control group. Findings will be used to support the development of a future, large~     scale study to test the efficacy of this intervention to improve cognitive functioning,~     quality of life, and physiological markers of improved brain function in HF. In addition, we~     have an optional sub-study that participants may participate in order to further our~     understanding of biomarkers of inflammation and gen e expression before and after exercise.~   "
69224|NCT02151253|"~     The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as~     a means of improving residual daytime sleepiness in patients with treated nocturia.~   "
69225|NCT02151240|"~     The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and~     Sodium Chloride Injection in patients with herpes zoster, and observe incidence of~     Postherpetic neuralgia~   "
69226|NCT02151227|"~     Magnesium is an essential mineral found in many foods; rich sources include whole grains,~     green leafy vegetables, coffee, and legumes. Magnesium is a critical cofactor in >300~     enzymatic reactions, including those related to energy metabolism. Reduced magnesium intake~     and serum concentrations have been detected, both cross-sectionally and prospectively,in~     type 2 diabetes and insulin resistance, hypertension, dyslipidemia, and cardiovascular~     diseases.~      Different studies have reported inadequate magnesium intake and low serum magnesium~     concentrations may correlated also with metabolic syndrome, defined as a cluster of~     metabolic disorders including obesity, hypertension, dyslipidemia and impaired glucose~     tolerance or diabetes mellitus. Previous studies on this subject, however, reported~     contradicting results. Some investigations reported inadequate magnesium intake and low~     serum magnesium concentrations while others did not.~      To our knowledge, the epidemiological evidence on the relation between dietary magnesium~     intake and risk of metabolic syndrome has not yet been summarized.Therefore, the~     investigators will perform a systematic review and dose-response meta-analysis to assess the~     association between dietary and circulating magnesium level and risk of metabolic syndrome.~   "
69227|NCT02151214|"~     In malnourished patients in the palliative phase of cancer, the question is raised of the~     relevance of implementing artificial nutritional assistance instead of oral feeding when~     this is possible.~      Medical prescription and implementation of artificial nutrition at this stage of the illness~     seem less governed by data acquired by science than by subjective reasons (related to~     beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply~     ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with~     teams, the patient and his family and relatives.~      And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition~     in a palliative situation for patients presenting with a normal alimentary tract is poorly~     understood. The discomfort and risks of central venous or nasogastric artificial nutrition~     require that the benefits of artificial nutrition be proven. The nature of these benefits~     relate first and foremost to the quality of life experienced by the patient in such a~     context. Only a controlled randomized study may lead to an optimal palliative nutritional~     management of undernutrition to be determined, and to inform the patient and his/her~     relatives clearly in order for them to express their preferences.~      We hypothesize that abstaining from artificial parenteral central venous nutrition and~     associated hydration for nutritional purposes improves quality of life without significant~     loss of survival compared to implementing artificial nutrition, when considered, in the~     absence of any specific curative treatment in anorexic patients in the palliative phase of~     cancer.~      To test this hypothesis, we propose to carry out a multicenter, prospective, controlled,~     randomized study in order to evaluate the efficacy of implementing parenteral nutrition~     compared to abstaining from doing so on the quality of life of undernourished patients in~     the palliative phase of cancer. The effect on overall survival and the nutritional~     parameters will be evaluated.~      The ALIM K trial will be carried out in 12 centres specializing in supportive and~     onco-hematology care .~   "
69228|NCT02151201|"~     We evaluated the impact of viewing an educational video about influenza vaccination in~     pregnancy just prior to a routine prenatal visit on vaccination health beliefs and~     vaccination rate. We hypothesized that the video would positively impact both vaccination~     health beliefs and vaccination rate compared to a control video.~   "
69229|NCT02151188|"~     This study hypothesizes that milk protein consumed together or shortly before a white rice~     or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic~     responses.~   "
69230|NCT02151175|"~     We intend to use focused ultrasound to stimulate or suppress brain activity in patients with~     epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or~     suppression visible with functional MRI, and will not cause tissue damage.~   "
69253|NCT02150876|"~     Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over~     first-generation DES with promising results on long-term adverse events. But the thicker~     polymer and/or strut may hinder its deliverability. Complex procedures challenge stent~     deliverability and stent delivery failure impacts clinical prognosis.~      This registry aimed to assess the immediate performance of the third-generation Synergy~     everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer~     population.~   "
69231|NCT02151162|"~     The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based~     stress management program to maintain healthy mental state in hospital nurses. The~     participants will be junior nurses who work in inpatient wards and are not clinically~     depressed. The participants will be randomly allocated to four intervention arms: 1)~     Mindfulness-based stress management program plus omega-3 fatty acids pills ; 2)~     Mindfulness-based stress management program plus placebo pills; 3) Psychoeducation leaflet~     plus omega-3 fatty acids pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty~     participants will be allocated to each arm. These interventions will terminate until three~     months from registration for each participant.~      Information about depression and anxiety symptoms (primary outcome), insomnia, burnout,~     presenteeism, quality of life, sick leave, consultation about mental state of herself, and~     oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months~     from registration for each participant.~   "
69232|NCT02151149|"~     Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly~     subject (≥ 70 years old) with advanced NSCLC~   "
69233|NCT02151136|"~     The purpose of this study is to determine whether sugar water (TootSweet, 24% sucrose)~     effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as~     measured by pain scores and cry duration~   "
69234|NCT02151123|"~     The specific aim of the study is to determine the false negative rate of the Metabiomics~     Colon Polyp and Colorectal Cancer Assay for Cancer.~   "
69235|NCT02151110|"~     Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920~   "
69236|NCT02151097|"~     This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence~     Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will~     be imaged using the LightPathTM Imaging System which consists of a light-tight box~     containing an ultra-sensitive lens and radiation-shielded camera. This study will measure~     the correlation between margin status of the WLE specimen and the metastatic status of~     dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology.~     This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate~     the benefits of the LightPathTM system in clinical practice.~   "
69237|NCT02151084|"~     This is a phase II study (the second stage of testing a new drug or new drug combinations)~     to see how useful two different schedules of study drug selumetinib with cisplatin and~     gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer.~      Selumetinib, an oral drug which plays an important role in the regulation of cell growth~     (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and~     other types of human cancers. Selumetinib has also been shown to shrink tumours when given~     in combination with cisplatin and gemcitabine in research studies done in animals and in~     some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs~     that work by damaging DNA in tumor cells so that they are unable to grow and divide.~   "
69238|NCT02151071|"~     This study will correlate the resection margin status of the breast cancer tumour (WLE~     specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary~     lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study~     to assess feasibility before proceeding to a pivotal study to evaluate the use of these~     imaging systems in clinical practice.~   "
69239|NCT02151058|"~     The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth~     rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days~     compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest®~     3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed~     toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to~     compare to brushing alone.~      225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be~     in this study will have an equal chance of being assigned to one of the three treatment~     groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline~     3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of~     use). Volunteers will maintain a diary at home to record each treatment use. Examinations~     for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes~     with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and~     5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product~     use).~   "
69240|NCT02151045|"~     In discal sciatica, after failure of medical treatment, the investigators propose frequently~     a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently,~     some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of~     indications of this type of infiltration. An alternative would be to propose a lateral~     epidural infiltration on contact with conflict.The objective of this study is to compare, in~     112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target~     posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control~     versus an epidural infiltration of the same corticoid done in lateral on contact of disco~     radicular conflict on scan control.~   "
69241|NCT02151032|"~     The goal of this research study is to compare how people who are 45-75 years old respond to~     3 different versions of a program about screening tests for colorectal cancer. Researchers~     want to use this study as part of a long-term project to learn the best ways to communicate~     health information to patients.~   "
69242|NCT02151019|"~     The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D~     Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for~     locally advanced rectal cancer.~   "
69254|NCT02150863|"~     This project aims to treat field cancerization ( pre-skin cancers) in a manner that will~     reduce the future pre-skin cancers and non-melanoma skin cancers in patients with~     significant photodamage.~      This is 3 year prospective, randomized, controlled comparison of a single treatment with~     carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal~     skin graft from a non sun exposed site vs. control.~      Thirty subjects will receive treatment with each of the modalities.~      The primary measures of efficacy are (a) count of the number of actinic keratosis and non~     melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs~     taken before and after the treatments, and (c) change in histology before and after~     treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and~     infection~   "
69243|NCT02151006|"~     140 women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided~     into 2 groups using computer generated random numbers . Group 1 ( study group) will receive~     DHEA 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI~     cycle. Group 2 ( control group) will not receive DHEA. Patients included in the study will~     be subjected to full history taking and clinical examination. On the second day of~     menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral~     follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined~     as the number of follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On~     the day of HCG administration, ovarian ultrasound scan will be performed using a~     transvaginal probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes~     will be fertilized and embryos will be transferred. Both groups will be compared regarding~     the proportion of pregnancy.~   "
69244|NCT02150993|"~     FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West~     Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo, Guinea).~      ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.~      The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2~     infected adult patients, in West Africa. A treatment will be considered as effective if more~     than 55% of patients in that arm attain global success at 96 weeks.~   "
69245|NCT02150980|"~     Background: Worldwide, injuries from trauma represent a major public health problem. The~     World Health Organization (WHO) has deemed this problem as one of the most important global~     priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is~     little empirical data in low and middle-income countries quantifying the burden of~     musculoskeletal injuries.~      Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The~     primary objective of the study is to determine the mortality, re-operation and infection~     rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS~     study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and~     Latin America.~   "
69246|NCT02150967|"~     This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor~     activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic~     alterations.~   "
69247|NCT02150954|"~     The purpose of this research study is to compare induction of labor using a foley catheter~     bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of~     oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor~     induction in patients whose cervix is not significantly dilated or thinned out (effaced).~     Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's~     contractions.~   "
69248|NCT02150941|"~     Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus,~     stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding.~     However, blood clots often make visualization difficult during endoscopy. The current~     practice is to try to wash off and suction up these blood clots with the endoscope. However,~     this is often not successful due to blood clots blocking the suction channel.~      A new device has been approved by Health Canada that attaches to the endoscope and helps~     prevent blockage. It is believed that this device will help doctors suck out blood clots and~     potentially improve visualization, identification of the cause of bleeding, and possibly~     health outcomes, although this has never been proven. The purpose of the this clinical trial~     is to test whether the device works and whether it can help patients with this type of~     bleeding.~   "
69249|NCT02150928|"~     The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18~     to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli~     asparaginase or pegaspargase.~   "
69250|NCT02150915|"~     The purpose of this study is to test whether the application of acupuncture alters the~     mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of~     discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses~     of the neurodynamic test of nerve median in asymptomatic individuals~   "
69251|NCT02150902|"~     Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart~     beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to~     normal rhythm. The technique sends out electrical energy through a catheter (long thin round~     solid tubes) to destroy the heart tissues in a focused area where AF is starting. This~     technique is practiced at many hospitals, including the Heart Institute, and is not~     experimental.~      The AWARE study will compare two techniques of AF catheter ablation:~        1. Ablation of tissues in wide circular bands around the opening of the pulmonary veins~          (bring blood back from lungs) in the left upper chamber of the heart. A medicine called~          adenosine will be given to unmask any incompletely ablated area. Additional ablations~          will be given if required. This is standard procedure.~        2. Same as above but adenosine will not be used. Instead, additional ablation of a second~          circular band of tissues around the opening of the pulmonary veins will be given. This~          additional ablation is not standard procedure and is considered experimental.~      We want to see if adding more ablation sites will help maintain normal heart rhythm and~     reduce the rate of return to AF. We will compare the occurrence of medical events and~     complications between the two groups.~      Identical supplies and equipment used in both techniques have been approved by Health~     Canada. Adenosine is currently approved by Health Canada for the treatment and diagnosis of~     arrhythmias.~      342 participants from The University of Ottawa Heart Institute will be randomly assigned~     similar to flipping a coin to treatment group 1 or group 2.~      After the ablation, participants can expect to remain in hospital for up to about 4 days.~     They will have study follow-up at the Heart Institute every 3 months for 1 to 3 years,~     depending on when they enter the study.~   "
69252|NCT02150889|"~     The investigators are interested in how skeletal muscle processes fat and how this may~     affect insulin resistance. This is an important question since insulin resistance predates~     and predicts type 2 diabetes. The investigators are especially interested in learning about~     the effects of weight and training on insulin resistance. The investigators will study~     people before and after supervised aerobic or yoga training to identify differences in~     resting fat and sugar metabolism which may lead to differences in insulin resistance. The~     investigators will test these differences using stable isotopes, and the use of these stable~     isotopes is experimental.~      Overweight/Obese Group: Eight visits will be required at the University of Minnesota~     Clinical Research Unit. Four visits will be done before training (screen and 3 pre-training~     visits), 1 visit during the training, and 3 post-training visits will be done. In between,~     the training will take about 16 weeks and will be a supervised treadmill program.~      Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical~     Research Unit (screen and 3 study visits).~   "
69255|NCT02150850|"~     Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients~     with osteoporosis and have in general an excellent safety profile. However, recent reports~     have noted that prolonged use of bisphosphonates may be associated with rare but serious~     adverse effects, namely atypical femur fractures (AFF), an atraumatic subset of~     subtrochanteric and diaphyseal fractures.~      The overarching aim of this project is to contribute to the characterization of clinical,~     biomechanical, radiological and genetic predictors of AFF, associated or not with~     bisphosphonate and-or denosumab therapy. AFF arise on the lateral (external) aspect of the~     subtrochanteric and diaphyseal regions of the femur, regions subjected to high mechanical~     loads. Because of this unique distribution, the investigators hypothesis is that patients~     with AFF demonstrate specific geometrical variations of their femur whereby baseline tensile~     forces applied to the lateral cortex are higher and might favour the appearance of these~     rare stress fractures. Measurements to investigate these geometric variations with be~     calculated from 3D images reconstructed using scans procured using the EOS® low irradiation~     2D-3D X-Ray scanner.~   "
69256|NCT02150837|"~     The purpose of this study is to retrospectively and systematically review records of~     overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to~     the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of~     the effectiveness of these programs. The study will describe demographics of this~     population, along with weight loss, anthropometrics, body composition and effects on~     available cardiovascular parameters. Adherence to the plans will also be examined.~      The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal~     Replacement Plan are both effective programs for weight loss in overweight and obese adults.~   "
69257|NCT02150824|"~     Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with~     type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable~     metformin background treatment over 28 days. Assess the effect on fasting plasma glucose~     after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of~     BI 187004.~   "
69258|NCT02150811|"~     The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in~     patient with interstitial cystitis/bladder pain syndrome~   "
69259|NCT02150798|"~     The aim of the present study was to evaluate the effects of a high fat, low carbohydrate~     (CHO) diet on clinical status during 60 days of follow-up in patients with stable heart~     failure (HF).~      In a randomized controlled clinical trial 44 ambulatory patients with HF were included,~     assigned to an intervention (40% CHO, 40% fat and 20% protein; n=22) or control groups (50%~     CHO, 30% fat, 20% protein; n=20). Both groups received recommended pharmacological~     management. At baseline and at 2 months of follow-up, the variables evaluated were: body~     composition, handgrip strength, oxygen saturation, dietary intake, clinical data, lipid~     profile, plasma glucose and exercise tolerance~   "
69260|NCT02150785|"~     Currently, thrombolysis is offered to less than 1% of patients in low to middle income~     countries (LMICs) where access to health care is often based on the financial capabilities~     of the patient. There is therefore an urgent need for an effective but affordable~     alternative thrombolytic agent. Streptokinase (SK) ($35) is much more economically feasible~     as opposed to tissue plasminogen activator (tPA) ($2800). In this study, we propose a~     reevaluation of the use of streptokinase (SK) in the treatment of acute ischemic stroke. We~     want to emphasize that we will only consider this as a 'treatment option' if we are~     absolutely certain that IV tissue plasminogen activator (tPA) will not be offered to the~     patient due to its high cost. It is hypothesized that treatment with SK in appropriately~     selected patients will be associated with a hemorrhagic transformation rate similar to that~     of tPA.~   "
69261|NCT02150772|"~     Background: The main goal when diagnosing thyroid nodules, is to differentiate the few~     malignant from the overwhelming background of benign nodules. Currently available~     pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic~     thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools~     for pre-operative diagnostic work-up of thyroid nodules.~      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography~     (SWE) in the pre-operative evaluation of thyroid nodules.~      Aim:~      To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in~     a tertiary surgical center.~      Perspectives:~      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules~     can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the~     economic and surgical resources.~   "
69262|NCT02150759|"~     -  Comparison study of analgesic effects for dexmedetomidine-fentanyl vs~          dexmedetomidine-ketamine~        -  lateral position for spinal anesthesia in femur proximal fracture patients~   "
69263|NCT02150746|"~     It is hypothesized that circulating tumor cells (CTCs) from pancreatic adenocarcinoma are~     released into the peritoneal cavity through blood lost during the surgical resection of~     these tumors resulting in peritoneal recurrence despite appropriate surgical resection.~     Targeting the mechanisms responsible for CTC adhesion to the peritoneum may result in~     inhibition of implantation and growth, thus preventing this mode of pancreatic cancer~     recurrence postoperatively.~   "
69264|NCT02150733|"~     This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic~     impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of~     hepatic function, from normal to severely impaired.~   "
69265|NCT02150720|"~     The main hypothesis of this clinical trial is that the use of intra-articular tranexamic~     acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative~     blood loss with respect to usual hemostasis in patients undergoing subcapital femoral~     fractures.~   "
69266|NCT02150707|"~     This study aims to determine if different diabetes treatments have different effects on~     inflammation; in particular, kidney inflammation. This type of inflammation is common in~     people with diabetes, and can lead to kidney failure. This study will investigate the effect~     of different types of diabetes treatment on kidney inflammation. This will help us to decide~     if certain types of medicine should be preferred in people with evidence of inflammation in~     their kidneys, as this may help prevent major complications including kidney failure.~   "
71398|NCT02122796|"~     The purpose of the study is to compare the effect of acupuncture to the standard of care~     (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay~     in post-mastectomy patients at Abbott Northwestern Hospital.~   "
69267|NCT02150694|"~     Apelins are substances which occur naturally in the body, and have an important role in~     heart disease. They have been shown to make blood vessels dilate, and improve the way the~     heart works.~      The investigators have devised 2 sets of experiments to investigate how the apelins affect~     blood vessels.~      In the first group of experiments,the investigators will give healthy volunteers up to 3~     different apelin substances, and use special research techniques to see how they affect the~     way that blood vessels work in the forearm.~      In the second group of experiments, the apelins will be given along with another form of~     apelin which blocks the effects of apelin in laboratory experiments. The investigators want~     to see if it blocks the effects of apelin in healthy humans.~      The investigators intend to test the hypothesis that:~      Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by~     an apelin receptor antagonist.~      This study will help us to understand more about how apelins work, and to suggest how they~     might be used to treat heart disease.~   "
69268|NCT02150681|"~     This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT)~     for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a~     history of mood disorders. MBCT is a short-term group psychotherapy that has shown~     effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and~     cognitive-behavioral techniques.~   "
69269|NCT02150668|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed~     childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms~     of ADHD relate to problems with temporal and materials organization (i.e. has difficulty~     organizing tasks and activities, loses things, is forgetful, and fails to finish~     school-work). In the school setting, problems with organization manifest as forgetting to~     complete or losing homework assignments, difficulties planning for the completion of~     long-term projects and studying for tests, and problems keeping class materials organized.~     These organizational difficulties become particularly problematic in middle school and are~     associated with low school grades and high parent and teacher ratings of academic~     impairment. In fact, organization of homework materials is one of the strongest predictors~     of academic performance in students with ADHD, above and beyond the impact of intelligence,~     school services, and ADHD medication use, and mediates the relationship between symptoms of~     ADHD and school grades.~      Given the relationship between temporal and materials organization and poor school~     performance, it is clear there is a need for interventions to address these difficulties.~     The PI sought to address this need by completing an IES Goal 2 study to develop a~     school-based intervention targeting organizational skills that was feasible for school~     mental health (SMH) providers to implement. The Homework, Organization and Planning Skills~     (HOPS) intervention was developed and refined based upon input from 20 school mental health~     (SMH) providers, students with ADHD and their families. SMH providers implemented the HOPS~     intervention, rated the intervention as highly user-friendly and feasible to implement, and~     demonstrated excellent fidelity to intervention procedures. Students who received the HOPS~     intervention made significant improvements in homework problems and organizational skills~     compared to a waitlist control. The feasibility and fidelity data demonstrate that the~     intervention has potential for widespread dissemination. Preliminary outcome data suggest~     that the intervention may significantly improve the academic performance of students with~     ADHD. However, the small sample size (N=23 HOPS & N=24 control) precludes firm conclusions~     about efficacy and moderators and mediators of intervention response. Accordingly, the~     primary goal of this Goal 3 study is to evaluate the efficacy of the HOPS intervention,~     which focuses teaching students' organization and time-management skills, as compared to an~     intervention targeting on-task behaviors during homework completion and efficiency of work~     completion, the Homework Support Intervention (HSI), and to assess moderators and mediators~     of intervention response.~      Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS~     intervention or the HSI intervention. Students in both groups will receive the same amount~     of intervention in terms of duration and frequency of intervention sessions. Six cohorts of~     students will be recruited for the project. Each cohort will consist of 22 students at each~     of two schools (44 per cohort) who will be randomly assigned to each of the two conditions.~     Objective measures of skills implementation, parent and teacher ratings of organization,~     homework problems, and academic impairment, and school grades will be examined pre and post~     intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity~     will be closely monitored. Moderator and mediator analyses will be used to answer important~     questions about the types of students most likely to benefit from organizational skills~     intervention and the key mechanisms of change that lead to improved academic performance.~     This study has significant potential to improve the academic performance of students with~     ADHD because the intervention was designed with SMH provider input and has clear potential~     for widespread dissemination upon proof of efficacy.~   "
69270|NCT02150655|"~     The overall objective of this clinical pilot study is to determine at a random sampling~     time, the vaginal microbiome and metabolome of pregnant women, and to see if infection~     (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental~     toxins affects could alter pregnancy and conception outcomes. It is hypothesized that~     infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk~     of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a~     preliminary assessment of the ability of orally administered probiotic lactobacilli to~     restore the vaginal microbiota to a healthy state and lower environmental toxins will be~     completed.~   "
69271|NCT02150642|"~     The investigators are interested in examining 1) the basic organization of spinal and~     cortical circuitry for the control of movement and 2) the influence of injury of these~     circuits. To investigate the neuronal circuitry, the investigators use various types of~     mechanical or electrical stimulation of the limbs, transcranial magnetic stimulation of the~     cortex and galvanic vestibular stimulation in both uninjured human subjects and subjects~     with a neurological injury (such as spinal cord injury, or Parkinsons's disease).~   "
69272|NCT02150629|"~     The study aims at discerning specific gait patterns and elucidating locomotor control of~     spinal cord injured patients in order to find sensitive kinematic and electromyographic~     outcome measures that are able to reveal information on underlying mechanisms of normal and~     aberrant gait control and its recovery over time. These measures may also be used to compare~     the outcome across different neurological disorders.~   "
69273|NCT02150616|"~     The purpose of this study is to investigate the effect of travelling to moderate altitude~     and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of~     patients with pulmonary hypertension or with interstitial lung disease.~   "
69274|NCT02150603|"~     The purpose of this study is to examine the differences in perceived health, psychosocial~     functioning, behavioral outcomes and quality of life of adults with congenital heart disease~     who are living in different areas of the world, and how these differences can be understood~     (e.g., differences in sense of coherence or illness perceptions).~   "
69275|NCT02150590|"~     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a~     stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung~     disease.~   "
69276|NCT02150577|"~     The objective of this Implementation Trial is to evaluate the implementation of evidence~     based practices for Bipolar Disorder and Treatment Resistant Depression in small rural~     Federally Qualified Health Centers. The evidence based practices chosen and adapted by~     Health Center providers and patients in consultation with clinical experts include:~     screening for and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line~     cognitive behavioral therapy, on-line peer support, collaborative care management and~     tele-psychiatry consultation. A quasi-experimental study design will be used, with each of~     the six participating Federally Qualified Health Centers choosing one implementation clinic~     and one control clinic. Implementation outcomes include: reach, adoption,~     implementation-fidelity and effectiveness. Providers and patients may choose to use all, any~     or none of the evidence based practices based on their needs and preferences. Data will be~     collected from chart review and patient surveys will be administered by an Interactive Voice~     Response telephone system.~   "
69277|NCT02150564|"~     Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand)~     in improving the extent of resection in intra-axial brain tumors. All patients will undergo~     resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the~     standard arm, only navigation will be used. This study will help in assessing the usefulness~     sononavigation in improving radicality of resection in malignant gliomas and also to access~     the accuracy of SonoWand in predicting residue (histopathological correlation).~   "
69278|NCT02150551|"~     In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells~     intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has~     not responded to conventional therapies. The goals of this study are to test the safety and~     tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease.~      Mesenchymal stromal cells support the development of blood cells within the bone marrow.~     When isolated from a donor and infused into an animal or human, they have been demonstrated~     to travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory~     cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection.~     These properties lead investigators to hypothesize that that these may be they may be~     beneficial in treating inflammatory bowel disease.~   "
69756|NCT02144324|"~     An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of~     maxillary deficiency in growing patients compared to the conventional facemask appliance~     treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial,~     sagittal and vertical skeletal measurements will be taken at three assessment times. Changes~     within each group will be assessed. In addition, the changes between the two groups will be~     compared.~   "
69279|NCT02150538|"~     This study was designed to evaluate the potential benefits of treatment with biventricular~     device in patients with normal systolic function , indication for pacing and impaired~     atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The~     REAL -CRT study is designed to test the hypothesis that, in patients with atrioventricular~     block of I degree and standard pacing indications , biventricular pacing is superior to~     single stimulation of the right ventricle (RV) with optimized algorithms for minimization of~     pacing , as assessed by echocardiography an endpoint defined in terms of maintenance over~     time of left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume~     ( LVESV ) .~   "
69280|NCT02150525|"~     This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on~     atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may~     reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.~   "
69281|NCT02150512|"~     The purpose of this study, in mechanically ventilated septic shock patients, is to determine~     whether a fluid loading strategy based on parameters derived from the transpulmonary~     thermodilution technique may lead to more ventilator free days compared to a fluid loading~     strategy based on the surviving sepsis guidelines.~   "
69282|NCT02150499|"~     This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects~     birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's~     office with an acute bronchospasm. Subjects presenting to the ED or physician's office with~     an acute bronchospasm must have a history of reactive airways disease, based on subjects'~     parent/guardian report.~   "
69283|NCT02150486|"~     To determine whether perioperative myocardial injury is associated with adverse outcome in~     patients scheduled for major abdominal surgery.~   "
69284|NCT02150473|"~     This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX)~     versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced~     magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive~     rheumatoid arthritis (RA), who had not previously received any Disease modifying~     antirheumatic drug (DMARD) or biologic treatment.~   "
69285|NCT02150460|"~     The aim of the study was to compare the efficacy and safety of single injection peribulbar~     anaesthesia against the classic double injection technique.~      This was a double blind randomized controlled trial involving two groups of consenting,~     adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who~     allocated the subjects to the two groups administered all the injections. The same surgeon~     operated on all the subjects while the principal investigator and a research assistant~     measured the outcome variables. All others were blinded as to subject allocation.~   "
69286|NCT02150447|"~     The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric~     cancer bleeding in inoperable patients.~   "
69287|NCT02150434|"~     The aim of the current study was to evaluate a new system (FreeO2) that automatically~     titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic~     obstructive pulmonary disease during exercise. The investigators hypothesized that~     continuous automatic adjustment of the oxygen flows during exercise would better maintain~     patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and~     would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen~     and with compressed air breathing.~   "
69288|NCT02150421|"~     The aim of the stuy is to investigate the effects of the adoption of a curriculum with~     electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their~     changes in refractive error and visual function.~   "
69289|NCT02150408|"~     Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived~     from the primitive gut and include digestive and bronchial NETs.~      Historically, the gold standard in their functional exploration is the conventional~     somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This~     reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity~     is moderate (60 %), because of its intrinsic detection limits, which could delay the~     diagnosis or lead to inappropriate therapy.~      The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68~     (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has~     improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS.~     Furthermore, patient irradiation and imaging protocol are significantly reduced.~   "
69290|NCT02150395|"~     This study looks at the effects of a protocolized music therapy intervention on state~     anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation,~     which is an imaging and diagnostic procedure, has been identified as producing significantly~     high levels of anxiety in many cancer patients.~   "
69291|NCT02150382|"~     China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test~     the effectiveness of a standardized protocol-based treatment program on hypertension control~     in rural China.~   "
69299|NCT02150278|"~     Objectives: The main objective of this pilot study is to assess the feasibility and~     effectiveness of a brief intervention to reduce drinking-driving behavior.~      Methods:~      Design: Pilot multicentre before/after intervention study without control group.~     Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65~     who declared to have consumed alcohol previous to driving, at least once in the past 30~     days. Intervention: Brief behavioral intervention to reduce alcohol consumption before~     driving. Outcomes: Frequency of driving under the influence of alcohol in the past 30 days,~     regular alcohol consumption (Audit-C test), level of self-efficacy and stage of change~     according to the Prochaska and DiClemente's Transtheoretical Model of Change,~     sociodemographic variables, driver's profile, chronic pathologies, long -term medications,~     level of self risk perception. Information will be checked against medical record.~     Information on a) frequency of driving under the influence of alcohol in the past 30 days,~     b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska~     State will be gathered at one month and 12 month post intervention. Descriptive bivariate~     analysis to assess the distribution of risk elements associated to drinking-driving~     behavior.~      Potential impact expected: This pilot project will determine the feasibility of making a~     brief advice intervention in drivers under the influence of alcohol in primary care.~   "
69292|NCT02150369|"~     -Purpose: Phase I: To test the methods, data collection and analysis in a study to evaluate~     cognitive/affective/sleep symptoms in one patient undergoing treatment with high-dose~     Interleukin-2 (IL-2) for metastatic renal cell carcinoma (RCC), their informal caregiver and~     their primary nurse.~      Phase II: A pilot study examining up to 10 IL-2 cases to describe cognitive/affective/sleep~     symptoms of patients receiving high-dose IL-2 therapy for metastatic melanoma (MM) or~     metastatic RCC in order to develop interventional studies to minimize these symptoms.~      -Aims: In this pilot, a case is comprised of the metastatic RCC patient receiving IL-2,~     their care partner, and their primary nurse. The care partner for this study will be the~     family member or friend staying with the IL-2 patient throughout treatment.~      Phase I (Evaluation of Methods and Procedures):~      One case will be examined to evaluate the methods, data collection and analysis to be used~     in this study. The aims of Phase I of this study are to: Aim 1) Evaluate recruitment and~     enrollment procedures to enroll one IL-2 case, comprised of the IL-2 patient, their care~     partner and their primary nurse; Aim 2) Evaluate administration procedures, data collected,~     and analysis of four questionnaire scales to detect the trajectory of cognition [Attentional~     Function Index and Montreal Cognitive Assessment] and affect [Hamilton Anxiety scale and~     Inventory of Depressive Symptomatology‒Clinician] in the IL-2 patient from the start to the~     end of a cycle of treatment; Aim 3) Evaluate procedures, data collected and analysis of~     journal entries from the care partner who are to record their thoughts, observations, and~     feelings concerning any changes in the patient's behavior or cognition during IL-2 treatment~     every 8 hours; Aim 4) Evaluate procedures, data collected and analysis of semi-structured~     questionnaires completed by the primary nurse taking care of the patient receiving IL-2~     which will describe any changes in behavior or cognition in the patient during their IL-2~     treatment; and Aim 5) Evaluate procedures, data collected and analysis of data of interviews~     with the IL-2 patient to further discern what symptoms endorsed on the measurement scales~     represent and how they are characterized, and interviewing the primary nurse to gain any~     additional data on cognitive/affective symptoms observed in the IL-2 patient.~      Phase II (Investigating Cognitive, Affective and Sleep Alterations in Patients Receiving~     high dose IL-2 therapy): Up to 10 additional cases will be enrolled to understand cognitive,~     affective and sleep symptoms induced from IL-2 therapy in oncology patients with MM or~     metastatic RCC, and help design future studies to ameliorate these treatment-limiting~     symptoms. The specific aims of this study are to: Aim 1) Describe cognitive (language,~     concentration, mental fatigue, confusion, attention, short-term memory, and orientation),~     affective (depression, anxiety, mood alterations), and sleep disturbance symptoms in~     patients receiving 1 to 4 cycles (up to 8-weeks) of high-dose IL-2 therapy. Aim 2) Examine~     observed patient experiences of cognitive/affective/sleep symptoms from each patient's~     primary care partner, and primary nurse during 1 to 4 cycles of IL-2 therapy. Aim 3)~     Describe the trajectories of cognitive/affective/sleep symptoms in patients with MM or~     metastatic RCC undergoing 1 to 4 cycles of IL-2 therapy. Not all patients will receive 4~     cycles of IL-2, because treatment will depend on a) disease progression and b) side effect~     toxicity; therefore, the symptom trajectory will be described for the cycles completed in~     situations where all cycles are not completed.~   "
69293|NCT02150356|"~     Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular~     risk factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched~     products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced~     homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total~     antioxidant status or endothelial function, whereas an improvement of C-reactive protein was~     observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of~     aleurone-enriched products with higher ferulic acid biodisponibility and longer time of~     treatment could influence these parameters in individuals with metabolic syndrome.~     Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting~     and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which~     aleurone may act in vivo are still unknown.~      The aim of this study is to investigate whether 8 weeks supplementation with~     aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones~     levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese~     subjects with high cardiovascular risk.~   "
69294|NCT02150343|"~     The purpose of this study is to compare the treatment effect of three treatment regimens of~     HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue~     medication usage, Quality of Life and Sleep Quality~   "
69295|NCT02150330|"~     Diminished ovarian reserve (DOR) is one the challenge in the field of artificial~     reproductive technology (ART) while there is still no effective resolution of this disorder.~     In patents with DOR, the pregnancy rate is about only 2-4%. Eventually, patients with DOR~     turn to adapt children instead. In recent studies, dehydroepiandrosterone (DHEAS) supplement~     might play a role in reverse diminished ovarian reserve and improve the prognosis of ART.~     Cumulus cells, formed cumulus-oocyte complex (COC) with oocyte, play a important role in~     folliculogenesis, oocyte maturation, oocyte meiosis and ovulation. Growing evidences~     disclose there are crosstalks between oocyte and cumulus cells as paracrine regulations.~     Aberration the crosswalks between oocytes and cumulus cells would be associated with poor~     prognosis of folliculogenesis and further pregnancy outcomes. In patients under ovarian~     hyper-stimulation protocol, the assessment of cumulus cells might be reliable indicators of~     folliculogenesis, embryo development, pregnancy rate and pregnancy outcomes. These genes~     (indicators), such as Hyaluronan synthase（HAS2), Versican (VCAN), Thrombospondin 1 (THBS1),~     Runt-related transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3),Tripartite~     motif-containing 28 (TRIM28), B-cell lymphoma 2 (BCL2)，BCL2-associated X protein (BAX). This~     study was assess the gene expressions of cumulus cells after the DHEAS supplement in~     patients with DOR under ovarian hyper stimulation protocol.~   "
69296|NCT02150317|"~     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)~     followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.~   "
69297|NCT02150304|"~     postdural puncture headache is a rare but serious complication of spinal anesthesia. many~     drugs were studied in prevention or treatment of that complication. However, there are~     limited numbers of trials about intravenous aminophylline for prevention. because of that we~     retrospectively aimed to investigate the effectiveness of aminophylline for postdural~     puncture headache in cesarean section.~   "
69298|NCT02150291|"~     Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining~     adequate doses of both drugs throughout the treatment period, the emergence of hematological~     side effects is expected and requires intervention. The hematological adverse effects lead~     to a trade-off between continuing the treatment with optimal dosage, to clear the virus,~     exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia,~     reducing thereby the chances of achieving sustained virological response (SVR). Therefore,~     we aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with~     different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety~     as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse~     effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus~     ribavirin in HCV patients will lead to better health outcomes and improvement in their~     quality of life (HRQOL).~   "
69323|NCT02149966|"~     This is a dose escalation study that will be conducted in healthy volunteers. Multiple~     cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348~     daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348,~     the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of~     AG-348 with specific biomarkers assessed in the blood.~   "
69757|NCT02144311|"~     The purpose of this research study is to learn if differences seen in scans before surgery~     match differences seen when looking at tumor samples with pathology and genetic tests. In~     this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography~     [PET] scans. No direct clinical benefits will come from the results of this study.~   "
69300|NCT02150265|"~     Background: There is need for more effectiveness studies concerning treatment of emotional~     symptom problems indicating anxiety and depression in adolescents. SMART is the only~     treatment manual for combined emotional disorders developed in Norwegian.~      Purpose: To find the best individualized treatment for adolescents with emotional~     difficulties by: Finding criteria for the selection of appropriate patients for treatment~     with cognitive-behavior therapy program SMART in an outpatient population (14-18 years).~     Finding predictors of completion of treatment program SMART. Examining the effects of~     treatment with the SMART program at 6 months follow-up.~      Design: A randomized controlled study in six outpatient clinics in the north of Norway. N=~     160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of~     the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the~     SMART-manual immediately, while the waiting list control group is treated with SMART after~     six weeks.~      Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.~      Publication: The results sought published internationally and nationally and will be~     communicated to clinicians.~   "
69301|NCT02150252|"~     -  Clinical trial; Ischemic stroke; Bu-Yang-Huan-Wu Tang （BYHWT）; Gait parameter; Quality~          of life Stroke is the third of ten causing death disease constantly, and it also is~          third of consuming healthy insurance budget. There is 17,000 peoples disable due to~          stroke every year in Taiwan. Although ischemic stroke patient may use t-PA~          intravenously treatment within 3 hrs after stroke onset in modern medicine, and no~          others method may effect to treat ischemic stroke patients, thus, the study about~          stroke is an important issue. Bu-Yang- Huan-Wu Tang (BYHWT) has been became a main~          stream for the treatment of stroke after Qing dynasty Wang Qing-Ren theory that is~          BYHWT may treat stroke due to pattern of qi stagnation and blood stasis in traditional~          Chinese medicine. A number of researches report that BYHWT can reduce blood viscosity,~          anti-inflammation, enhancing neuronal regeneration and angiogenesis, but~          above-mentioned about BYHWT limit in the level of animal study and the scientific~          evidence is insufficiency in human trial. Therefore, the purpose of the present study~          was to investigate the therapeutic effect of BYHWT treating ischemic stroke by using a~          strict clinical trial.~        -  We designed a randomized, double blind, placebo-controlled study to assess the~          therapeutic effect of BYHWT treating ischemic stroke. The study expects to finish the~          assessment of 120 patients with ischemic stroke in three years. The study divided into:~          1) control group, receive placebo-BYHWT 3.0 g TID every day for continuously 6 weeks~          except ordinary medical care; 2) treatment group, the method is identical control~          group, but receive BYHWY. The main outcome was according to the changes of gait~          parameter including Speed, Cadence, Strike length, Gait cycle and Double support; and~          secondary outcome including the changes of Functional independence measurement scores~          and Barthel index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg~          Balance Test and WHO quality of life-brief (Taiwan Brief).~        -  We predict the results of the present can provide scientific evidence to proof BYHWT~          can improve neurological deficit and also can improve quality of life in patients with~          ischemic stroke.~   "
69302|NCT02150239|"~     Pain management is becoming an important ethical responsibility of the medical profession~     and a focus of the health care system. However, there are limited literature evaluate the~     postoperative pain experience and management in our local setting.~   "
69303|NCT02150226|"~     The objective of this work is to study in-mouth aging and LTD of monolithic zirconia~     restorations. Microstructural changes characteristic of LTD processes, wear, and clinical~     behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D~     laser surface analysis will be used, directly on the restorations, which will be removed at~     regular intervals.The working hypothesis is that LTD process is very slow at the scale at~     the lifespan of dental prostheses.~   "
69304|NCT02150213|"~     To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study~     CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).~   "
69305|NCT02150200|"~     Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000~     hysterectomies are performed each year in France. Laparoscopic surgery is in progression.~     The percentage of hysterectomies performed laparoscopically is increasing. The advantage of~     laparoscopy include fewer infections, less operative pain, faster recovery time and shorter~     hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy~     reduced to 3-4 days.~      The study hypothesis is that a shorter postoperative stay does not decrease the quality of~     life of the patients.~      This study will compare the evolution of quality of life (with a questionnaire concerning~     measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3~     days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.~   "
69306|NCT02150187|"~     HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this~     study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair~     growth in men with tendencies for hair loss.~   "
69307|NCT02150174|"~     When people are tested on a previously learned material, they will latter remember it better~     even when compared to a condition where they can re-study it. This phenomenon is called~     retrieval practice and is supported by an extensive research literature mostly carried out~     in normal students. This paradigm begins to be used in cognitive remediation programs in~     patients suffering from memory difficulties.~      The objective of this study is to investigate whether retrieval practice is spared in~     patients with schizophrenia.~      If effective, this method could be used in cognitive remediation programs.~      Since episodic memory difficulties are supposed to be secondary to deficits in the~     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that~     retrieval practice is spared in schizophrenia~   "
69308|NCT02150161|"~     The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared~     to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of~     postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.~   "
69309|NCT02150148|"~     Cancer survivorship has been claimed a national priority, with a call to develop effective~     interventions that can prevent, delay, or mitigate the adverse effects and comorbidities in~     this high risk population. Strong evidence exists that a healthful diet and regular physical~     activity can prevent many chronic diseases and improve physical function. More research~     however is needed to develop interventions that can produce long-term adherence to healthful~     lifestyle behaviors. This pilot study is based on the hypothesis that vegetable gardening~     interventions will be feasible and result in improvements in diet and exercise behaviors as~     well as improvements in physical functioning and well-being.~   "
69310|NCT02150135|"~     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their~     quality of life have seriously deteriorated. There have been a few studies that showed an~     effect for pain control by hyperthermia (heating the patient's body). However, there are~     several limitations in conventional hyperthermia. In this study, the investigators tried to~     show the effect of Oncothermia which is more selective to malignant tissue than~     conventional hyperthermia for pain control, increasing quality of life, and anti-tumor~     treatment.~   "
69311|NCT02150122|"~     It is known that low vitamin D status is a very common problem in the UK. It is also known~     that a lack of vitamin D availability has potentially serious health implications,~     especially with respect to bone and muscle function. Much research has recently taken place~     to establish the vitamin D requirements of key population groups (i.e. pregnant women, the~     elderly, ethnic minorities). However few data are available describing the vitamin D~     requirements for male and female adolescents. The period of adolescence is a key stage of~     growth and development - poor nutrition during this time can have detrimental health~     consequences for a lifetime.~      No intervention studies have comprehensively investigated the vitamin D requirements of~     adolescents. The proposed ODIN Study will enable a better understanding of how adolescents~     respond to vitamin D supplementation and the most effective daily amount that will raise and~     maintain vitamin D status in adolescents during the winter-time. In addition, investigations~     into the mechanisms of action with respect to any differences observed across the doses of~     vitamin D and between the genders of the participants will also provide key information.~     Mechanisms of action will focus on genetic differences as well as differences in vitamin D~     metabolising enzymes.~      The results obtained from this significant study will not only inform the European Food~     Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D~     recommendations. The ODIN Study will also inform the UK Department of Health's Scientific~     Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical~     resource for key stakeholders (i.e. food industry, government health agencies) to~     collaborate in determining future public health strategies, thus potentially positively~     impacting on the health of the population for years to come.~      The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day~     (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and~     females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a~     range of thresholds between 30 and 50nmol/l.~   "
69312|NCT02150109|"~     The purpose of this study was to determine if untrained persons with diabetes and without~     diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain~     valid blood glucose results.~   "
69313|NCT02150096|"~     The objective of this study is evaluate the laser and ultrasound effect on pain and~     disability in women with non-specific chronic low back pain.~   "
69314|NCT02150083|"~     Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women.~     Many surgical procedures have been developed to treat SUI, and midurethral slings have~     gradually become the first line treatment. Voiding dysfunction, or inability for a patient~     to empty her bladder, immediately after surgery is common. A bladder test is often performed~     in the recovery area to see if the patient is able to empty her bladder. This typically~     consists of filling the bladder with 300 mL of saline through the foley catheter. The~     catheter is then removed and the patient is asked to void. The investigators then measure~     the voided volume and the residual left inside the bladder to determine if she is able to~     empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3~     of the total volume in the bladder and having less than 100 mL left inside the bladder as~     residual. Our goal of this study was to evaluate efficiency and effectiveness of a~     retrograde postoperative voiding trial that is initiated in the operating room. Our~     hypothesis was that a retrograde postoperative voiding trial initiated in the operating room~     would be as effective as a standard retrograde postoperative voiding trial to predict~     postoperative voiding dysfunction while allowing for patients to spend less time in the~     recovery unit.~   "
69315|NCT02150070|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics~     (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production~     clone and also following single ascending doses of subcutaneous (SC) injections of the same~     clinical trial material.~   "
69316|NCT02150057|"~     Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to~     participate in this randomized study. Subjects will be assigned to either a Fusion~     Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is~     hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on~     osteoarthritis knee pain and quality of life compared to those who do not receive bracing~     intervention.~   "
69317|NCT02150044|"~     This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial~     that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery~     System (TTDS).~   "
69318|NCT02150031|"~     The first time the American Heart Association (AHA) suggested that disinfection of the~     gingival sulcus be performed as a complement to antibiotic prophylaxis in patients~     considered to be at risk of Infective endocarditis (IE) was in their protocol for the~     prevention of IE published in 1977. This practice was included by the AHA and adopted by~     other expert committees such as the British Society for Antimicrobial Chemotherapy (BSAC) in~     subsequent prophylactic regimens. In 1992, the BSAC specified the presentation and~     concentration of chlorhexidine (CHX) that should be used before starting the dental~     procedure: 1% gel at the gingival margin or 0.2% mouthwash for five minutes. In 1997, the~     AHA recognised the need to use antiseptic mouthwashes (CHX or povidone iodine) prior to~     dental manipulations, although they recommended against the use of gingival irrigators and~     against the continuous use of antiseptics in order to avoid the selection of resistant~     micro-organisms In 2006, the BSAC recommended a single mouthwash with 0.2% CHX gluconate (10~     ml for 1 minute) before performing dental procedures associated with bacteraemia in patients~     at risk of IE. In contrast, in 2007, the AHA recommended against the use of any antiseptic~     prophylaxis protocol.~      In 2008, the National Institute for Health and Clinical Excellence of the United Kingdom~     recently performed a systematic review of the antimicrobial prophylaxis protocols for IE and~     reported that: Oral chlorhexidine used as an oral rinse does not significantly reduce the~     level of bacteraemia following dental procedures. This conclusion was reached after~     analysis of numerous studies on the efficacy of prophylaxis with CHX for the prevention of~     post-dental manipulation bacteraemia. However, those studies presented significant~     methodological differences not only in the dental procedures performed, but also in the~     concentration of CHX applied and the method of application of the antiseptic solution~     (mouthwash and/or irrigation), making comparison of the results of the different series~     difficult.~      There are few studies that have analysed the efficacy of the mouthwash of 0.2% CHX (the~     concentration recommended by the BSAC) in the prevention of post-extraction bacteraemia.~     Only one study analysed the combination of local irrigation and mouthwash with chlorhexidine~     before dental extraction, but with a really lower concentration of CHX, only 0.02%.~      The objective of this study is to investigate the prevalence, duration and aetiology of~     bacteraemia secondary to a single tooth extraction after prophylaxis with different CHX~     protocols.~   "
69319|NCT02150018|"~     Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical~     impedance tomography~   "
69320|NCT02150005|"~     Objective: The aim of this study was to examine the effects of non-surgical periodontal~     treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an~     indication for surgical revascularization.~      Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age~     (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11),~     received periodontal treatment before the surgical procedure, and control group (n=11), did~     not received periodontal treatment prior to surgery.~   "
69321|NCT02149992|"~     Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European~     studies. It is not known exactly how this occurs or what it does to the sugar when the~     supplement is taken. This study purpose is to look at the patient's sugar levels while~     taking the supplement to see if the overall levels of sugar go down. We hypothesize that in~     addition to sugar levels, other hormones influencing diabetes will be altered.~   "
69322|NCT02149979|"~     The purpose of this study is to evaluate the safety and effectiveness of using Temperature~     Controlled Laser Soldering System for soft tissue bonding.~   "
69324|NCT02149953|"~     It is important that pregnant women eat an adequate amount of protein to ensure healthy~     growth and development of the fetus. Amino acids are the building blocks of the body's~     protein. Glycine is an amino acid that can be made in the body, but under certain metabolic~     circumstances (e.g. pregnancy) the body's needs may be higher and glycine may need to be~     obtained from the diet. Currently, it is not known if glycine may be needed from the diet~     during pregnancy. We plan to study dietary glycine requirements in healthy pregnant women,~     during early and late gestation. We will do this using a modern, safe and quick method.~      The purpose of the study is to determine the dietary glycine requirement in healthy pregnant~     women during mid (20 - 30 weeks) and late (31 - 40 weeks) gestation.~      The investigators hypothesize that there is a dietary requirement for glycine during~     pregnancy due to an increased metabolic demand. With increased glycine intake the~     investigators hypothesize to observe an increase in protein synthesis, as measured by the~     indicator amino acid oxidation (IAAO) method.~   "
69325|NCT02149940|"~     Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality~     rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been~     shown to have a beneficial impact on heart failure related outcomes. Regardless, a high~     residual event rate is to be noted.~      In our pilot study, we wished to document whether a clinical pharmacist could still play a~     role in the heart failure management of an elderly inpatient heart failure population.~   "
69326|NCT02149927|"~     In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC~     during unconsciousness have been reported. These results are in accordance to recent~     electroencephalographic studies observing impaired top-down processing during anesthesia. In~     this study, simultaneous records of functional magnetic resonance imaging (fMRI) and~     electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms~     during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in~     electroencephalogram.~   "
69327|NCT02149914|"~     Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content~     induced by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can~     effectively block gastric acid secretion but the drug reactions and the degree of~     improvement in symptoms are sometimes unpredictable. The aim of this study is to investigate~     the association between the clinical efficacy of PPI in patients with GERD and the personal~     physical status by Ryodoraku and ANSWatch.~   "
69328|NCT02149901|"~     The specific aim of this study is to determine whether water ingestion potentiates the~     pressor response to pseudoephedrine in patients with primary disorders of autonomic failure.~     The study design will enable us to also evaluate the pressor response to water alone and to~     pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with~     two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We~     hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater~     increase in blood pressure than pseudoephedrine alone.~   "
69329|NCT02149888|"~     Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate~     burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure~     prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel~     biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in~     reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV~     prevention interventions including counseling, testing/treatment of sexually transmitted~     infections (STIs), and condoms. There is now widespread mobilization to assess the~     feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects'~     addressing real-world PrEP implementation issues.~      PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP~     implementation issues including acceptability, effectiveness, impact on sexually transmitted~     infections, and strategies for supporting adherence outside the clinical trial setting. The~     investigators have also established a comprehensive community-based research program~     investigating the role of community-based organizations in PrEP implementation and delivery.~   "
69330|NCT02149875|"~     The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12~     hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a~     10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National~     Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the~     efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were~     also analyzed among the three groups.~   "
69331|NCT02149862|"~     The purpose of this study is too assess infrared spectroscopy ability to discriminate urine~     of a patient affected by bladder cancer from urine of reference patient.~   "
69332|NCT02149849|"~     Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as~     surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral~     shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates~     that ISP can be caused by the positioning of the patient during surgery due to muscle -and~     ligament strain. Can a change in the surgical positioning (less press and stretch) of the~     ipsilateral arm effect the shoulder pain after thoracic surgery?~   "
69333|NCT02149836|"~     The purpose of this study is to test the antidepressant effects of Ezogabine in major~     depressive disorder (MDD). The investigators also aim to determine the safety and~     tolerability Ezogabine in patients with MDD. The investigators hypothesize that depressive~     symptoms will be significantly decreased following an 8-week treatment period of the~     medication compared to baseline.~   "
69431|NCT02148549|"~     FOLFIRINOX regimen was recently presented at an international oncology meeting and~     represents a new standard regimen in the treatment of metastatic pancreatic cancer.~     FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered~     as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of~     grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the~     FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the~     balance of safety and efficacy as a preoperative chemotherapy, the investigators use the~     FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of~     180mg/m2 from FOLFIRINOX regimen~   "
69432|NCT02148536|"~     To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt~     (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).~   "
69334|NCT02149823|"~     Social cognition impairment is critical to the pathology and morbidity of a number of~     psychiatric disorders, including the schizophrenia spectrum and the personality disorders,~     thus representing a dimension consistent with RDoC. As such, this study aims to a) further~     characterize the unique deficits in social cognition (recognition and interpretation of~     social cues and representation of thoughts, intentions, and feelings of others) in~     borderline personality disorder (BPD) and schizotypal personality disorder (SPD) compared to~     healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and~     novel treatment of social cognition impairment in these disorders; and c) enhance our~     understanding of the specificity and exact mechanisms of impairment to inform the accurate~     dosing of OXT required to modulate social cognition in these disorders and identify a model~     of optimum social cognitive function. Addressing these questions will further catalyze~     research into a model of optimum social cognitive activity, and accelerate industry~     development of agents suited to routine clinical administration.~   "
69335|NCT02149810|"~     Depression is a leading contributor to global burden of disease. Antidepressants do not~     provide adequate response for many patients. Mind-body therapies are often safe,~     increasingly embraced by patients albeit the limited good quality clinical trial data. The~     PI has shown that there is autonomic instability in patients with late life depression~     (LLD). Through his team of across discipline researchers he will investigate benefits of one~     adjunctive mind-body intervention, automatic self transcending meditation on autonomic~     instability in LLD and depressive symptoms compared to treatment as usual. If results are~     positive, such an intervention could be used for management of LLD across all levels of~     care.~      WHAT IS THE INNOVATION AND MAIN QUESTION/HYPOTHESIS UNDERLYING THIS PROPOSAL? The main study~     objectives are to assess heart rate variability (HRV), other autonomic parameters and~     depression scores in patients with late life depression undergoing an innovative mind-body~     therapy 'automatic self-transcending meditation' (ASTM) not previously evaluated in a~     randomized controlled manner in the treatment of late life depression:The investigators~     hypothesise that in patients with LLD treatment as usual(TAU) +ASTM will lead to a~     significant increase in HRV from baseline to end of study period as compared to treatment as~     usual TAU. The investigators also hypothesise that ASTM+TAU will cause a significant~     difference in other autonomic parameters including heart rate and blood pressure changes in~     presence of a physiological stress test (hand grip), depression and depression related~     pathologies such as anxiety and improve quality of life compared to TAU.~      It is expected that adding ASTM to TAU will be better than TAU in improving HRV, depression~     severity and other autonomic parameters in the treatment of LLD. It is expected that this~     intervention will produce significant anxiolytic and enhanced quality of life outcomes and~     will have no major side effects. If the results of this study are positive, it is possible~     that this intervention could be considered as treatment option for the management of this~     disabling illness in primary, secondary and tertiary care. Such treatment option would be~     more cost and staff effective, and self empowering than the current standard of care. It~     could also provide treatment options for patients who are currently resistant to their~     antidepressants.~   "
69336|NCT02149797|"~     Cholecystectomy is one of the most common operation performed by general surgeons. Since,~     first video-laparoscopic cholecystectomy in 1987, laparoscopic cholecystectomy (LC) has~     become the gold standard treatment for benign biliary disease. In daily practice, LC has~     increased general surgeons familiarity to video-laparoscopic operations and has become the~     first step to search more minimally invasive techniques and to perform advanced laparoscopic~     operations. In order to move forward the minimal invasive surgery concept with less surgical~     trauma and better cosmetic results, surgeons firstly reduced the number of incision and~     ports, then the idea of totally eliminating skin incisions through the use of natural~     orifices was implemented in selected cases.~      In theory, minimal incision must provide minimal postoperative pain and better cosmetic~     results. With the use of single-incision laparoscopic cholecystectomy (SILC), this purpose~     is achieved by means of cosmesis but providing minimal postoperative pain is still~     controversial. Recent reports on, LC vs. SILC showed significantly favorable cosmetic~     benefit, comparable complication rate and hospital stay with SILC, but the mean operation~     time was significantly longer. Today, lack of standardized operation technique, the need for~     specialized instruments, the fear of inability to apply safe cholecystectomy principles,~     longer operation time, cost-effectivity and advanced laparoscopic experience are still~     limiting factor to performing SILC.~      The aim of this prospective randomized controlled trial is to compare gold standard LC and~     SILC using our new technique called Pick'n roll (SILC-PR). Our goal was to provide~     critical view of safety and safe cholecystectomy principles on SILC, improve operator~     ergonomics and shorten operation time while eliminating the need for specialized~     instruments.~   "
69337|NCT02149784|"~     There is still no perfect treatment suggestion for patients with asymptomatic colorectal~     cancer with unresectable metastatic disease. Whether patients can benefit from palliative~     resection of primary tumor or not is still waiting for answer. The investigators hypothesis~     that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will~     benefit from primary tumor resection.~   "
69338|NCT02149771|"~     The purpose of this study is to determine whether TACE combined endovascular stent~     implantation confers a survival benefit over TACE alone.~   "
69339|NCT02149758|"~     The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal~     inflammation by:~        1. improving clinical periodontal parameters and,~        2. improving the salivary SOD levels.~   "
69340|NCT02149745|"~     The purpose of this study is to find if we can shorten the recovery time by calling the~     patient's name during anesthesia reversal.~   "
69341|NCT02149732|"~     To investigate the effect of ocular surface reconstruction and assess the safety in~     cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients~     with cicatricial change of ocular surface.~   "
69342|NCT02149719|"~     Peanut allergy is increasingly common, especially in countries such as UK and Australia.~     There is currently no accepted routine clinical therapy to cure peanut allergy. Recently~     studies have looked at desensitising people with peanut allergy by giving them small daily~     doses of roasted peanut. Although this therapy works for some people, its effects are not~     generally long lasting and it is associated with many side effects during protocol,~     resulting in a significant rate of drop-outs.~      Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may~     therefore provide a safer way of inducing desensitisation in patients who are allergic to~     roasted peanut, by first inducing tolerance to boiled peanut.~      Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted~     peanut, in peanut-allergic individuals.~   "
69343|NCT02149706|"~     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study~     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary~     Progressive SPMS.~   "
69433|NCT02148523|"~     To assess the effectiveness of social comparison in improving the outcome of statin~     adherence versus usual care as measured by an electronic pill bottle.~      Subjects receiving weekly reports with their adherence and information about their place in~     the distribution of their peers will have the highest statin adherence of any arm, as~     measured by electronic pill bottle.~   "
69434|NCT02148510|"~     The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on~     respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same.~     The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment~     and the cost of treatment during one year.~      This randomized controlled parallel group multicenter study includes 316 subjects referred~     for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit~     the clinic at 5 scheduled occasions.~   "
69344|NCT02149693|"~     Medical education was transformed from mainly didactic class before 19th century to the~     clerkship and internship training based on the concept of learning by doing in 20th~     century. There are new challenges for medical education in the 21th century, including~     knowledge explosion, the importance of communication and teamwork in clinical care, and lack~     of comprehensive and systemic experiential learning. Therefore, another paradigm shift of~     medical education in this century is necessary. This research project, through applying~     high-fidelity simulation, resuscitation teamwork model, and concept of flipped classroom in~     resuscitation training, take the innovation and reform of resuscitation training as a pilot~     test for paradigm shift of medical education.~      This research project is a 4-year project. Three innovative intervention for resuscitation~     training will be developed, implemented, and evaluated. There will be 4 phases in this~     project:~        1. Development phase (1st year): establishment of structure, validity and reliability~          test, faculty development, and course preparation.~        2. Experiment phase (2nd year): comparative studies will be conducted.~        3. Implementation phase (3rd year): integration and implementation of innovative~          interventions.~        4. Evaluation phase (4th year): effectiveness evaluation and analysis of learning~          retention.~      Through innovation, development, implementation and effectiveness evaluation in this 4~     phases, this research project hope to integrate high-fidelity simulation, resuscitation~     teamwork model, and concept of flipped classroom, into resuscitation training successfully~     and appropriately. Furthermore, these experiences can provide the bases of paradigm shift in~     medical education in the future.~   "
69345|NCT02149680|"~     Accidental dural puncture (ADP) during placement of an epidural catheter for anesthesia and~     analgesia is a well known complication. Previous studies have found audiometric~     deterioration following ADP. Epidural blood patch (EBP) is a common method for treating~     postural headache in patients with accidental dural puncture. In most cases, one-two patches~     are needed for successful management. Long-term effects of EBP on the incidence of backache,~     headache and early audiometric deterioration are few or non-existant. The present study aims~     to determine the long-term sequelae of EDP in parturients who had ADP and were treated with~     an EBP during the years 2005 - 2011.~   "
69346|NCT02149667|"~     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the~     safety and efficacy of its total hip arthroplasty (THA) components marketed in the European~     Union (EU) . These types of studies are required by regulatory authorities for all THA~     devices that do not have medium to long-term clinical evidence available at the time of~     gaining approval to market in the EU. This study has been designed in accordance with MEDDEV~     2.12/2 rev 2.~   "
69347|NCT02149654|"~     Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic~     Valve Implantation System in a real world environment.~      Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market~     study.~      250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1~     month, 6 months, and 12 months after the procedure. The recruitment period will be~     approximately 12 months, so the total study duration will be 24 months.~   "
69348|NCT02149641|"~     In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2)~     subjective xerostomia at 1 year.~   "
69349|NCT02149628|"~     Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and~     trendelenburg position which result in oxidative stress and inflammatory response.~      Propofol is well known to reduce those responses during anesthesia. Therefore, we try to~     figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and~     increase the nitric oxide activity during robot-LRP compared to that of desflurane.~      To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory~     markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric~     oxide will be measured as well.~      Secondarily, kidney protection effect of propofol over desflurane will be compared.~   "
69350|NCT02149615|"~     The exact incidence of optic disc swelling and idiopathic intracranial hypertension in~     patients using antiacne medication is not known so far. The investigators hypothesize that~     swelling of retinal nerve fibre layer measured by optical coherence tomography is more~     frequent then assumed so far.~   "
69351|NCT02149602|"~     This study is a phase II trial designed to test the feasibility of delivering IMRT to head~     and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx),~     and to assess possible improvement in reducing the incidence of xerostomia with bilateral~     superficial lobe parotid sparing IMRT.~   "
69352|NCT02149589|"~     To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal~     versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS~     prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS,~     Recruitment maneuvers, high PEEP and low V twill be used.~      The investigators made the hypothesis that ventilation according to Lung morphology my~     decrease mortality at D90.~   "
69360|NCT02149485|"~     Since 1995, preimplantation genetic diagnosis (PGD) has been performed in The Netherlands~     for couples at high risk for transmitting severe or lethal genetic conditions or who have~     experienced multiple miscarriages due to chromosomal translocations. Approximately 260~     children have been born after PGD in The Netherlands. Follow-up data on children born after~     PGD are scarce. Long-term studies on PGD children have not been conducted in The~     Netherlands. Results of studies in other countries on 2-year old PGD children are~     reassuring. These children and their parents have normal scores on relevant parameters such~     as general health, cognitive and socioemotional development, parent-child interaction and~     parental stress. Studies of good methodological quality of older children have not yet been~     published.~      Objective: Long-term follow-up of children who have been born after PGD in The Netherlands.~     The primary aim is to assess the safety of PGD with regard to the health and development of~     the children.~      Study design: A cohort study. Study population: 5- and 8 year old children born after PGD in~     The Netherlands for various indications and their parents. Control groups consist of 5 and~     8-year old naturally conceived (NC) children of parents who have considered PGD treatment~     and 5 and 8-year old children born after in vitro fertilisation/intracytoplasmatic sperm~     injection (IVF/ICSI), and the parents of the two latter groups of children.~   "
69435|NCT02148497|"~     The purpose of this study is to show that the multi-colored Placido Disk set-up can get~     reliable data over long time periods.~   "
69353|NCT02149576|"~     After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or~     development of a new cancer. Historically, patients who have undergone curative lung cancer~     surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such~     patients still die of lung cancer. As a result, there has been interest in other methods of~     surveillance in order to detect recurring or new cancers earlier and have more success in~     treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently~     the standard of care and surveillance at this institution. This pilot study aims to~     determine whether regimented, intensive, short interval LDCT surveillance leads to higher~     rates of detection and treatment of recurring lung cancers. The study group will be followed~     up according to a regimented surveillance program using LDCT. The study group will be~     compared to a group of historical controls whose follow up after surgery was not~     standardized, but rather left up to the discretion of the individual surgeon. If the results~     of this study show improvements in detection and treatment of recurrent cancers, it will~     allow for a larger trial to study the effects of the LDCT surveillance program on lung~     cancer survival.~      The study question aims to determine whether for survivors after curative surgery for Stage~     I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase~     the rate of detection and treatment of recurring or new cancers when compared to historical~     non-structured surveillance with CXR. This study will also determine if it is warranted to~     pursue a larger scale randomized controlled trial to further investigate optimal LDCT~     surveillance follow-up intervals and long-term lung cancer survival.~   "
69354|NCT02149563|"~     The major objective of the present study is to examine the influence of normobaric hyperoxia~     treatment on the symptoms of patients diagnosed with depression members of Clalit Health~     Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the~     symptoms of patients with depression.~   "
69355|NCT02149550|"~     An effective vaccine against malaria is urgently needed to combat the scourge of this~     disease. Before candidate vaccines can be tested in endemic countries, they are first tested~     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a~     candidate vaccine should be tested against multiple strains of malaria, representative of~     the disease's global distribution. Recently we compared, for the first time, infections with~     the novel malaria strains NF135 and NF166 to those with the broadly-used and~     well-characterised strain NF54.~      The purpose of the current study is to optimise the course of infections with these novel~     strains by determining the minimum number of infectious bites necessary to reliably induce a~     malaria infection.~   "
69356|NCT02149537|"~     The vast majority of births with sickle cell disease (SCD) occur in Africa and 90% are~     thought to die before the age of five. Hydroxyurea (HU) is the only drug approved by the FDA~     for the treatment of sickle cell anemia. Although HU is used to treat small numbers of~     patients in Africa, cost, fear of toxicity, and lack of awareness and availability limit its~     use. The leukopenia that may be seen with HU raises the possibility of increased~     susceptibility to infection. Risk stratification - i.e., identification of patients most~     likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is~     favorable. Several clinical measures of future risk are well defined and findings on~     modifier genes in the US, primarily related to fetal hemoglobin (HbF), have further improved~     risk prediction. Whether the genetic variants predict severity in Africa is not known. The~     investigators have established a SCD cohort in Ibadan, Nigeria. In the first phase of this~     research the investigators will implement clinical risk examinations and assess the~     relationship between clinical characteristics (including levels of HbF) and known genetic~     markers. As a proxy for a birth cohort, the investigators will compare the frequency of the~     genetic markers in adult patients (i.e., survivors) to children. In the second phase the~     investigators will randomize 40 high risk adult patients to fixed low dose HU or no HU~     treatment in a crossover design and monitor hematologic and physiologic parameters to~     document hematologic effects and safety. This work will lay the basis for a large-scale~     trial to document safety and efficacy.~   "
69357|NCT02149524|"~     A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the~     Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab~     biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally~     Advanced Breast Cancer in Neoadjuvant Setting~   "
69358|NCT02149511|"~     In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the~     level of the lesion provides evidence of neural degeneration; however, the spatial and~     temporal patterns of progression and their relation to clinical outcomes are uncertain. New~     interventions targeting acute spinal cord injury have entered clinical trials but~     neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim~     to use MRI to assess neuronal degeneration above the level of the lesion after acute spinal~     cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic~     spinal cord injury and healthy controls. We assess patients clinically and by MRI at~     baseline, 2 months, 6 months, and 12 months 24 months and 60 months, and controls by MRI at~     the same timepoints. We assess atrophy in white and brain matter and we use cross-sectional~     spinal cord area measurements to assess atrophy at cervical level C2/C3. We use~     myelin-sensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps to~     assess microstructural changes associated with myelin. We also assess associations between~     MRI parameters and clinical improvement.~   "
69359|NCT02149498|"~     A cornerstone in PD research is the investigation of neurophysiological changes as potential~     biomarkers that could help in tracking disease progression and response to therapies.~     Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for~     identification of such biomarkers. In this study we will use high-density~     electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that~     could be more sensitive and reliable to disease progression and response to therapeutic~     intervention than standard clinical measures.~   "
69375|NCT02149277|"~     The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF~     on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection)~     protocols as well as in frozen embryo transfer. In addition, following the injection, the~     level of G-CSF in the bloodstream will be verified.~   "
69376|NCT02149264|"~     This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and~     safety of FE 999303 (Testosterone gel) in adult hypogonadal males.~   "
69361|NCT02149472|"~     Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and~     mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage~     during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH~     can be taken.~      In this study the investigators aim to identify haemostatic parameters that during the~     course of haemorrhage are responsible for the on-going towards major bleeding. By doing~     this, cut-off points can be defined for future interventions aiming to stop this bleeding~     process in an early stage. Traditional coagulation parameters are currently not useful for~     clinical decision making, because of long turn around times. Therefore the added value of~     available coagulation 'point of care' tests will be evaluated during obstetric~     haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic~     therapy for obstetric haemorrhage.~      A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From~     all women a bleeding score will be obtained during their pregnancy by means of a validated~     questionnaire. The predictive value of this bleeding score for the occurrence of major~     obstetric haemorrhage will be evaluated.~      If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for~     conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding~     and major bleeding will be elucidated. Interchangeability and comparability of conventional~     haemostatic parameters and ROTEM profiles will also be evaluated.~      The overall goal of the investigators is becoming more able to predict major obstetric~     haemorrhage in an early stage of postpartum haemorrhage and define thresholds for~     goal-directed hemostatic therapies.~   "
69362|NCT02149459|"~     Recurrent brain tumours are extremely aggressive and despite optimal treatment, median~     survival is less than two years. One of the standard treatment options in this situation is~     radiation therapy. Currently there is intense scientific interest concerning the abnormal~     energy metabolism in cancer cells. All cells require energy in order to function, obtaining~     'fuel' molecules such as glucose and fatty acids from the blood stream. Brain tumours~     exhibit metabolic reprogramming, meaning that their energy requirements and utilization of~     fuel molecules are quite different from normal cells. Brain tumour cells are exquisitely~     dependant on glucose as a source of energy. Animal studies have shown that when these~     tumours are deprived of glucose they are very sensitive to radiation therapy.~      In this clinical trial the investigators combine radiation therapy with a low-carbohydrate~     diet, in patients with recurrent brain tumours. In addition, subjects will receive~     medication with metformin, a drug usually used to treat diabetes. Metformin inhibits glucose~     metabolism within cancer cells, and additionally has reported intrinsic anti-cancer~     activity. Subjects will undergo advanced imaging and hormonal studies before, during and~     after the trial in order to obtain maximal translational-scientific impact.~      The hypothesis:~      The metabolic changes induced by the combination of a moderately-low carbohydrate diet~     combined with supplementary MCT and metformin therapy will selectively starve tumor cells.~     While normal brain cells are capable of deriving energy from ketone bodies during glucose~     restriction, tumor cells remain largely glucose-dependent for energy due to oncogene induced~     down-regulation of oxidative phosphorylation. While the tumor cells are in this 'vulnerable'~     state they will be less able to repair the damage induced by ionizing radiation.~      Short-term implementation of the metabolic intervention (i.e. combined diet and metformin~     therapy) prior to, during, and after hypofractionated (2 week) radiation therapy is expected~     to increase tolerability, increase compliance and avoid the chronic metabolic complications~     associated with extreme carbohydrate restriction diets.~   "
69363|NCT02149446|"~     Dividing pancreas when performing left-sided resections opens the risk for leakage from the~     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding~     abdominal tissues with abscess formation producing systemic inflammation and potential~     lethal bleeding.~      Studies have shown that reinforcement of the staple line when dividing pancreas could reduce~     the risk of leakage.~      Surgisis (COOK Medical) a product already in use for staple line reinforcement in gastric~     and lung surgery could be used as a reinforcement when stapling pancreas in left sided~     resections.~      In a prospective randomized trial we want to compare Surgisis reinforcement to no~     reinforcement of stapled division in left sided pancreatic resections.~      Primary outcome is pancreatic fistula yes/no.~   "
69364|NCT02149433|"~     This is a double-blind randomized controlled trial assessing the efficacy of adjuvant~     corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.~   "
69365|NCT02149420|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics and~     therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS~     patients~   "
69366|NCT02149407|"~     Feeding intolerance is a common problem in preterm infants.~   "
69367|NCT02149394|"~     The purpose of this study is to assess the efficacy of ice popsicle compared with water at~     room temperature in relieving thirst in the immediate postoperative period . The hypothesis~     of the study is that ice has 20% greater efficacy than water to relieve thirst in the~     immediate postoperative period.~   "
69368|NCT02149381|"~     A total of 384 patients suffering from chronic depressive disorder will be randomized to~     receive treatment as usual, CBASP, or befriending for a period of five months. The primary~     outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes~     in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and~     neurophysiological parameters. The data gathering is performed at pre- and post intervention~     stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the~     participants six months after the intervention.~   "
69369|NCT02149355|"~     Patients suffering from congenital fourth cranial nerve palsy may have misalignment of jaws~     as well as teeth due to head tilt in childhood.~   "
69370|NCT02149342|"~     This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and~     methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using~     randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and~     12 months. Pain during and after treatments and adverse reactions at one week are recorded.~   "
69371|NCT02149329|"~     A multicenter open-label non-inferiority randomized clinical trial comparing the safety~     (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal~     carbapenem with regard to treatment failure in comparison with extended treatment (at least~     9 days) of high-risk febrile neutropenia in hematology patients receiving standard~     antimicrobial prophylaxis.~   "
69372|NCT02149316|"~     The purpose of this study is to determine whether remote ischemic preconditioning with~     postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in~     heart transplantation surgery.~   "
69373|NCT02149303|"~     This study is being conducted to collect data on the management of major bleeding events~     occurring in patients with atrial fibrillation taking dabigatran etexilate.~   "
69374|NCT02149290|"~     This study will evaluate the accuracy of data on body position, daily activity, heart rate,~     6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator~     (WCD).~   "
69378|NCT02149238|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. Aging is the major~     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial~     function, vascular stiffening and increase in blood pressure.~      However, in addition to flavanols, other potentially bioactive compounds are present in~     cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa~     methylxanthines, i.e. mainly theobromine, in particular when consumed together with~     flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient~     interaction between cocoa flavanols and cocoa methylxanthines.~   "
69379|NCT02149225|"~     The primary objective of this study is to assess the safety and tolerability, feasibility~     and biological activity (immunogenicity) of the actively personalized vaccination (APVAC)~     concept in newly diagnosed glioblastoma (GB) patients.~   "
69380|NCT02149212|"~     About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its~     highest incidence occurs from the second decade of life, affecting significantly the~     economically active population. Chronic Venous Insufficiency treatment aims to relieve~     symptoms, treat and prevent complications, prevent recurrences and provide cosmetic~     satisfaction with minimal side effects. It's current treatment includes some classic~     postural measures (leg elevation), elastic stockings and bandages compression therapy and~     possible medication (phlebotonics). The results in the medium and long term are unfavorable,~     since a large number of patients do not get better or evolves with recurrence of symptoms.~     Nowadays many, no prospective , not randomized , international studies have shown favorable~     results with endovascular treatment of obstruction in the iliac vein territory in patients~     with advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded~     randomized study is to evaluate the results obtained with endovascular treatment, through~     the use of angioplasty and stenting in this group of patients when compared with clinical~     treatment .~   "
69381|NCT02149199|"~     The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is~     effective in treating asthma when used 'as needed' in patients with milder asthma. The~     efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as~     needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline~     Turbuhaler® 'as needed'.~   "
69382|NCT02149186|"~     This project will build and test the first rehabilitation system employing virtual reality~     (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and~     motor dysfunction in participants with an incomplete spinal cord injury or another~     neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for~     legs). Patients using the system will control virtual representations of their legs to~     engage in entertaining gaming interactions.~   "
69383|NCT02149173|"~     This clinical trial studies use of [F-18] 16 alpha-fluoroestradiol ([F-18] FES) positron~     emission tomography (PET) in measuring tumor hormone receptor expression in patients~     undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer~     that has come back or spread to other places in the body. Comparing results of diagnostic~     procedures done before, during, and after hormone therapy may help measure a patient's~     response to treatment.~   "
69384|NCT02149160|"~     The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics~     of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin~     mutation.~   "
69385|NCT02149147|"~     The purpose of this study is to investigate the variety of physical activity, a~     cross-sectional design will be used. The data collected will provide descriptive details~     about how people are engaging in physical activity, as well details about the environment~     they are in while engaging in physical activity.~   "
69386|NCT02149134|"~     Cow's milk protein allergy is defined as an immunological reaction to one or more milk~     proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's~     milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of~     prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's~     milk protein allergy prevalence is often due to differences in study populations, study~     design and a lack of defined diagnostic criteria. The importance of defined diagnostic~     criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids~     delay in diagnosis, which can lead to malnutrition.~      There are two clinical types of cow's milk protein allergy: the immediate and the delayed~     type. The immediate type usually presents within minutes after the ingestion of cow's milk~     protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is~     present in slightly more than half of the patients with cow's milk protein allergy. Delayed~     reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or~     enteropathy usually present after hours or days.~      Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated~     reactions are often of the immediate type. Non-IgE mediated reactions are often cell~     mediated or mixed cell and IgE mediated and are more difficult to prove by specific testing.~     The immunological reaction differentiates cow's milk protein allergy from other milk induced~     pathology such as lactose intolerance.~      A variety of symptoms can be suggestive for cow's milk protein allergy although none of them~     is diagnostic. A good medical history remains the cornerstone for the diagnosis.~      The treatment of cow's milk protein allergy is the dietary elimination of cow's milk~     proteins. In non-breastfed infants and children less than 2 years of age, a substitute~     formula is mandatory as prescribed by several international scientific societies.~     Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed~     formula is often a whey or casein based formula in which the protein has been chopped up in~     smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and~     nutritional inadequacy, the use of any other animal milk or soy-based formula is~     precluded.The infant should be maintained on an elimination diet until the child is between~     9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms~     will improve substantially within 2-4 weeks if diagnosis is correct.~      According to consensus in literature, a therapeutic formula is a formula tolerated by at~     least 90% (with 95% confidence) of cow's milk protein allergy infants.~      The aim of the investigators study is to show the efficacy, tolerance and nutritional~     adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a~     proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will~     have been diagnosed based on a double blind placebo controlled food challenge, considered as~     golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the~     formula, the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk~     protein allergy infants following literature consensus. A symptom diary will be filled out~     for this purpose by the patients' parents or legal guardians and the patient will be~     followed clinically by his doctor several times during the study period.~      Nutritional adequacy of the formula will be evaluated clinically by following growth and~     weight several times during the study period and by comparing it to the standard WHO growth~     curves, based on breastfed infants.~   "
69387|NCT02149121|"~     This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,~     Rituxan and MabThera in Patients with Rheumatoid Arthritis.~   "
69388|NCT02149108|"~     The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients~     with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard~     chemotherapy and biological agents.~   "
69389|NCT02149095|"~     TransCon PEG treprostinil is a novel prodrug form of treprostinil, in which treprostinil is~     reversibly conjugated via a four-arm branched polyethylene glycol (PEG) molecule. Reversible~     coupling of treprostinil to PEG should allow for a modified extended pharmacokinetic profile~     to achieve sustained plasma concentrations of treprostinil.~      This will be the first investigation of TransCon PEG treprostinil in humans. This study aims~     to determine the maximum tolerated dose (MTD) and assess the safety, tolerability and~     pharmacokinetics of escalating single doses of a subcutaneous injection of TransCon PEG~     treprostinil.~   "
69390|NCT02149082|"~     This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density~     (OD) measurement with an Infrascanner device accurately identifies the presence of an~     intracranial hematoma in pediatric patients ≤18 years of age after known or suspected~     traumatic brain injury compared with head computerized tomography (CT) scans as the gold~     standard.~   "
69391|NCT02149069|"~     A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to~     patients undergoing complex surgical procedures.~   "
69436|NCT02148484|"~     Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual~     abuse survivors and is associated with substantial psychosocial and medical problems, but~     evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the~     efficacy and effectiveness of prolonged exposure therapy for adolescents with~     client-centered therapy.~   "
69758|NCT02144298|"~     The aim of this study is to observe the perioperative course of sublingual microcirculatory~     alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood~     compared with cristalloid cardioplegia. Additionally the impact of changes in hemodynamic~     parameters, blood gas, laboratory findings and standart therapy for intra and early~     postoperative period was studied. Intubation time, ICU stay, hospital stay, ICU readmission,~     morbidity and mortality were recorded.~   "
69392|NCT02149056|"~     Background About 2/3 patients of coronary heart disease (CHD) are complicated with disorder~     of carbohydrate metabolism which results in hyperglycemia and subsequent abnormality of~     coagulation system and inflammation. These patients have serious coronary artery pathology,~     multiple complications and poor prognosis. Platelets and lymphocytes play important roles in~     the occurrence and progression of atherosclerosis. The platelet/lymphocyte rate (PLR) is one~     simple hematological index. Previous studies confirmed that PLR could predict the long-term~     mortality of non-ST elevated myocardial infarction (NSTEMI). If simple hematological index~     could predict the prognosis of such kind of patients, it will provide new thought for early~     diagnosis and treatment in future. Therefore, the present study try to investigate if PLR~     could predict the poor prognosis of CHD patients complicated with impaired glucose tolerance~     (IGT) through calculating PLR.~      Methods/design The present study is performed with strategy of an observational and~     prospective single-centre cohort. These patients are recruited from August 2013 to August~     2014, according to the inclusion criteria of CHD complicated with IGT. CHD is confirmed with~     coronary angiography while IGT is determined according to the WHO criteria (1999). Routine~     blood test and serum glucose data of patients are acquired before hospitalization and~     surgery. According to the median of PLR after admission, the patients are divided into 3~     groups. The patients are followed up for half, 1 and 3 years, respectively. The major~     clinical endpoint is mortality. The minor clinical endpoint indices are the correlations of~     PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of~     target vessels), recurrent infarction, re-perfusion rate of target vessel, intra-stand~     thrombogenesis, stroke and acute onset of heart failure. The correlations are analyzed with~     receiver operating characteristics (ROC) survival curve and Kaplan-Meier survival analysis~     to find optimal prognosis index.~      Summary Through regression analysis of long-term follow-up of patients, it is expected to~     find optimal predicting index of prognosis. While judging whether PLR is effective, other~     possible factors for new predictor are sought in order to provide help for future study.~   "
69393|NCT02149043|"~     Ulcerative colitis represents a chronic condition occurring in relapsing and remitting~     fashion with uncertain outcome and requires lifelong treatment with considerable side~     effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or~     laboratory (C - reactive protein, calprotectin) give an insight into disease activity, but~     are possibly associated with significant discomfort for the patient and / or increased risk~     of irradiation and potential allergic reactions on contrast agents. For that reason there is~     a need for a noninvasive, biologically inert method for evaluation of disease activity in~     inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The~     aim of this study is to find potential link between pathological thermographic signs and~     endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of~     patients with active and extensive ulcerative colitis.~   "
69394|NCT02149030|"~     The main objective of the study is to identify whether or not being informed infrequently~     results about screening is: 1) At least as safe and accurate as frequently obtaining all~     information from the present combination of opportunistic/organized cervical screening by~     comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm~     A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human~     papillomavirus (HPV) vaccinated young women.~   "
69395|NCT02149017|"~     To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic~     radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and~     healthy volunteers.~   "
69396|NCT02149004|"~     Despite major advances in therapy and management, HIV/AIDS continues to be a major cause of~     infectious disease morbidity and mortality on a global scale. The discovery of effective~     antiretroviral treatment has turned HIV infection into a manageable chronic disease in most~     patients with access to care. However, the different economic and epidemiologic situation in~     developing and developed countries requires different research priorities, so that three~     main challanges are universal and in focus of research of the DZIF HIV Translational~     Platform:~        -  Prevention of HIV infection~        -  Long-term life with HIV~        -  HIV cure~      The Translation Reserach HIV will bring together clinical researchers in HIV infection in~     order to develop new treatment options to the above mentioned main challanges. It will take~     advantage of existing expertise (e.g. basic science, novel targets for treatment and HIV~     eradiation) of the partner sites. This platform is necessary because Germany's HIV research~     has suffered in the past from a lack of integration between its excellent basic science and~     clinical research. In addition, there was too little integration into networks that address~     the main international challenges. There is an urgent need to link these research strands~     through dedicated structures emphasising the translation of preclinical results into new~     therapies.~   "
69397|NCT02148991|"~     Arterial hypertension causes adverse effects on the entire cardiovascular system, with~     effects centrally such as diastolic dysfunction and structural changes of the left ventricle~     and, peripherally such as endothelial dysfunction and increased thickness of the vessels.~      Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc.~     further aggravate the prognosis of these patients.~      In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed~     arterial hypertension was 78% for women and 64% for male patients. This population consists~     from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more~     comorbidities and probably less compliance with antihypertensive therapy. Finally, at every~     age the disease and its effects can affect the quality of life of patients.~      The main purpose of this study is to investigate the efficacy of antihypertensive therapy~     (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular~     system (diastolic left ventricular function, the function of the endothelium (FMD) and the~     thickness of the common carotid artery).~      The secondary objective of the study is to monitor the quality of life (Quality of Life -~     QoL) of patients.~      Additionally the investigators will seek the correlation of results with co-morbidities,~     compliance, and patient age.~   "
69398|NCT02148978|"~     Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections~     and exocrine pancreatic insufficiency. The vast majority of patients with CF will develop~     pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The~     presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.~      The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter~     of investigation. In addition to localized tissue damage developing similar to that of the~     exocrine pancreas, additional mechanisms may be involved. The investigators have recently~     shown that insulin secretion in patients with CF is significantly altered prior to the~     development of diabetes. This phenomenon is associated with reduced secretion of gut derived~     incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether~     due to a deranged interaction of gastrointestinal contents with enterocytes resulting in~     reduced secretion or due to rapid clearance of such peptides) may be a major underlying~     driver of altered glucose metabolism in such patients.~   "
69399|NCT02148965|"~     Introduction World Health Organization estimates that nearly 10% of births are preterm~     worldwide. In the city of Pelotas, based on previous population studies, the preterm birth~     rate is increasing (6.3% to 14.7% from 1982 to 2004). Preterm birth (PB) is a major public~     health issue as it is associated to most cases of neonatal deaths and its consequences are~     linked to later health outcomes.~      One of the strongest predictors of PB is gestational hypertension (or eclampsia). PB risk~     and gestational hypertension may be altered by maternal behavior, such as leisure-time~     physical activity (LTPA), and overall maternal health influences the likelihood of both~     outcomes occurring. Biological plausibility lies on the fact that hypertension conditions~     are potentially influenced by LTPA directly or indirectly (as in the relation between~     excessive gestational weight gain and physical activity). Also, there is evidence that~     mental health plays a role in the determination of PB and, although biased by~     cross-sectional nature of studies, literature shows that physical activity may influence~     positively psychological aspects during pregnancy.~      In Brazil less than 20% of pregnant women are physically active during leisure. Physical~     activity during pregnancy is associated to several characteristics resulting in improved~     health profiles that could potentially decrease hypertension occurrence and consequently~     preterm birth rates. However, few clinical trials have been carried out to study such~     relationship in representative population samples and many of the available evidence are~     based solely on observational studies.~      Although early studies on the effects of leisure-time physical activity during pregnancy~     were concerned about potential harmful effects to the health of the mother and the fetus,~     these have not been proven over time. Currently, there is growing evidence supporting the~     safe promotion of physical activity during pregnancy targeting benefits to maternal and~     child health. However, most of the scientific evidence derives from observational studies.~     There is an urgent need for results from well-designed experimental studies that enable a~     better understanding of the impact of exercise during pregnancy on various health outcomes~     maternal and child.~      Methodology The intervention will start after the 12th and before the 20th week of gestation~     and will last until the end of pregnancy or when women feel uncomfortable with the exercise~     routine. The intervention will consist of three weekly exercise sessions. Each session will~     last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling)~     and strength training (with focus on major muscle groups and pregnancy-specific exercises to~     help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary~     incontinence). Workouts will be guided and supervised by physical education professionals~     previously trained. The intensity of the exercises will be set according to woman's fitness~     level and will be altered according to the progress of pregnancy based on the perceived~     effort. All exercise sessions will take place at the School of Physical Education from the~     Federal University of Pelotas.~   "
69401|NCT02148939|"~     Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates~     with increased age. Most of patients rely on analgesic medication to control the pain.~     Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and~     South America, largely due to its favorable analgesic and antipyretic effects in conjunction~     with a low incidence of gastrointestinal complications when compared to other non-steroidal~     anti-inflammatory drugs (NSAIDs).~      Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However,~     it is known that there are substantial inter-individual response variabilities to~     antiplatelet medication. Furthermore, patients with impaired response to aspirin have a~     significant higher risk of recurrent cerebrovascular events. The investigators have recently~     shown that co-medication with aspirin and dipyrone in patients with coronary artery disease~     lead to insufficient antiplatelet effects of aspirin.~      The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in~     this study the investigators aim to examine, if co-medication of aspirin and dipyrone~     interaction also occurs in patients after ischemic stroke.~   "
69402|NCT02148926|"~     This study is a descriptive study to investigate clinical and genetic features of dilated~     cardiomyopathy (DCM) patients and their relatives. 140 patients have been clinically~     characterized with clinical examinations including ECG and echocardiography, and furthermore~     they have had next generation sequencing (NGS) of 42 known DCM genes, and 34 candidate~     genes, 70 of these patients underwent heart transplantation. The data from NGS is validated~     by Sanger sequencing. In this study we will examine the relatives to the 140 index patients~     both clinically with advanced echocardiography including 3D volume measurements and~     speckle-tracking (GLS) and genetically if a disease related mutation was found in the index~     patient. Approximately 480 clinical examinations will be performed this way to be able to:~      1a. Investigate the frequency of familial types of DCM~      1b. To evaluate the genetic examinations properties to identify familial types of DCM~      2. To compare the genetic courses of DCM in the group of transplanted patients to the group~     of non transplanted patients, including the association between genotype and phenotype in~     affected DCM families.~      3. To investigate if there are subtle changes in the heart in genopositive individuals which~     do not meet the conventional diagnostic criteria evaluated by advanced echocardiography.~   "
69403|NCT02148913|"~     This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing~     autologous transplantation will receive a preparative regimen of melphalan, bendamustine,~     and carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen~     of melphalan and bendamustine in the setting of autologous transplantation for multiple~     myeloma is feasible and safe.~   "
69404|NCT02148900|"~     The objective of this study is to determine whether a simple blood test can be a useful~     clinical tool for monitoring aortic disease in Marfan syndrome and Marfan-related disorders.~   "
69405|NCT02148887|"~     We aim to investigate the effect of motor skill training of the upper and lower limbs on the~     function and structure of the CNS as measured by neuroimaging parameters sensitive to~     changes in tissue volume and density and the properties of myelin.~   "
69406|NCT02148874|"~     This study will examine effects of everyday life stress and obesity on immune responses to~     influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody~     levels against influenza (the flu) increase. Higher antibody levels indicate better immune~     protection from influenza. In addition to providing protection from the flu for yourself,~     being vaccinated during pregnancy may protect your baby from the flu during the first six~     months of life during which time infants cannot be vaccinated. Our primary goals are to~     determine whether greater life stress and obesity reduce 1) antibody responses to the flu~     shot in women and 2) antibody levels in the newborn at the time of delivery.~   "
69407|NCT02148861|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously~     administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes~   "
69408|NCT02148848|"~     Femoral neck fracture in the elderly is one indication for initiating osteoporosis~     treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons~     concern regarding their effects on fracture healing process. Therefore, therapy is usually~     delayed for a period of time. To the best of our knowledge, there is no scientific data to~     support whether bisphosphonate treatment should be given immediately after the surgery or it~     should be delayed.~   "
69409|NCT02148835|"~     New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our~     diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA,~     and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate~     bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will~     increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various~     sausages with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as~     compared to unsupplemented matching sausages. Safety and palatability of the sausages are~     also to be assessed.~   "
69410|NCT02148822|"~     The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess~     the association between malnutrition and visceral leishmaniasis (VL). It was conducted in~     Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical,~     anthropometric, biochemical, immunological, parasitological and sociodemographic data of~     school age children from VL high prevalence communities were collected in December 2009, May~     2010 and February 2011.~   "
69411|NCT02148809|"~     Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital.~     This type of anesthesia reduces the average arterial pressure. Benefits include reduced~     bleeding and lower risk of blood clots.~      The purpose of this study is to determine the effect of intravenous fluids administered with~     hypotensive anesthesia on your blood volume. With this parameter we will be able to~     understand how much of your blood is lost because of bleeding and how much of the drop is~     related to dilution.~      Study hypothesis: Hemodilution associated with intravenous fluid substitution during~     hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels~   "
69492|NCT02147756|"~     The purpose of this study is to compare structural changes in the skin caused by the CO2RE~     device versus the Repair.~   "
69413|NCT02148783|"~     Deficits in memory, attention, cognitive, and executive functions are the most common~     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is~     implicated in these neural functions and dopaminergic pathways are recognized to be~     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate~     (Ritalin®). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine~     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure~     tonic DA release provides valuable insight into the molecular basis of attention-deficit~     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding~     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging~     with [11C]-raclopride, a D2/D3 receptor ligand, before and after administering~     methylphenidate, to measure endogenous DA release in patients who are experiencing problems~     with cognition, attention and executive function in the chronic stage after TBI. In~     addition, we will use TMS to test short intracortical inhibition, a gamma-aminobutyric acid~     receptor A (GABAA) - mediated phenomenon, which is under partial DA control, as a measure of~     dopaminergic activity on and off methylphenidate.~   "
69414|NCT02148770|"~     Neuroimaging is becoming increasingly common to investigate the neural networks underlying~     eating behaviour and food preference in normal-weight and obese humans. It has been observed~     that obese in comparison to lean individuals display altered activation patterns in networks~     of brain areas involved in reward, emotion and cognitive control. Interestingly, obese~     individuals who are capable of losing weight appear to have a stronger connectivity between~     areas related to food value and to the control of eating behaviour. The same areas are also~     associated with healthy food choices. It has been suggested that activation in the~     prefrontal control areas indirectly modulate valuation-related activity. Based on this,~     brain-related intervention strategies to support weight loss and long-lasting weight~     maintenance are of particular interest. Hence, we first want to examine the effect on eating~     behaviour of neurofeedback training-induced up-regulation of functional connectivity between~     reward- and impulse-related brain areas as a pilot, and second we want to examine~     up-regulation of the activity of prefrontal control brain areas.~   "
69415|NCT02148757|"~     Purpose of this study is to determine the incidence of deep venous thrombosis after partial~     knee replacement.~   "
69416|NCT02148744|"~     This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled,~     ascending dose study to investigate the safety, tolerability, and pharmacokinetics of~     XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.~   "
69417|NCT02148731|"~     MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are~     better at detecting vulnerable patients and that they are a better Adverse Events~     predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients~     referred for chemotherapy. The second hypothesis is that a brief screening tool based on a~     combination of some frailty markers and some used in the CGA would help the oncologist~     detect patients requiring a more complete geriatric assessment~   "
69418|NCT02148718|"~     Rapidity of response to treatments in inflammatory bowel diseases is now considered a field~     of major interest, due to the importance of achieving the highest benefit in the shortest~     possible time, in order to favor a fast backward step to normal life. There are no previous~     studies specifically designed to evaluate the rapidity of response to adalimumab therapy in~     patients with active Crohn's disease. Studies on rapidity of onset of response to adalimumab~     have, on the other hand, been performed in other diseases such as rheumatoid arthritis~     (Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis HERO study, Wolfe et al,~     2006). This trial will assess the clinical responses occurring earlier than in week 1. This~     is an open label, one arm, prospective, multicenter, phase IV clinical trial.~   "
69419|NCT02148705|"~     This study will be a three-arms study intending to demonstrate superiority of NexoBrid~     treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn~     subjects.~      The study objectives are:~        1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing~          complete eschar removal as compared with Gel vehicle,~        2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing~          earlier complete eschar removal, reduction in patients' surgical burden and its related~          blood loss as compared to SOC,~        3. To assess the safety of NexoBrid compared to SOC, including demonstration that~          treatment with NexoBrid does not cause an unacceptable level of harm on wound closure~          outcome and long term outcomes of cosmesis and function.~      Physicians will define one or more Target Wounds (TWs) per subject according to TWs~     definition. All subjects' deep (DPT and FT) burns that comply with the specified entrance~     criteria are intended to receive study treatment per the randomized study arm.~      The randomization procedure will be initiated only after all Target wounds of a subject have~     been defined. Patients will be assigned to the treatment arm in a 3:3:1 ratio (NexoBrid: SOC~     : Gel Vehicle).~      Patients will be treated in the same way in all study arms (NexoBrid, SOC or Gel vehicle)~     except for the eschar removal stage which will be performed as per the randomization study~     arm.~      Prior to initiation of eschar removal treatment, subjects will be medicated with appropriate~     analgesia and undergo wound cleansing and dressing of all wounds with antibacterial~     solutions . Following wound cleansing and antibacterial treatments, subjects will undergo~     the eschar removal process as per treatment assignment (NexoBrid, SOC or Gel Vehicle,~     following randomization).~      Subsequent to complete eschar removal, all wounds will be assessed and treated in the same~     manner, in accordance with post-eschar removal wound care strategy. Post eschar removal,~     subjects will undergo daily vital signs and pain assessments, until hospital discharge (HD)~     and weekly assessments of wound progress, until wound closure. Following wound closure~     confirmation visit, subjects will be followed up at 1, 3, 6, 12, 18 and 24 months post wound~     closure for long term outcomes evaluation.~   "
69420|NCT02148692|"~     Postoperative respiratory failure, particularly after surgery under general anesthesia, adds~     to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use~     positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may~     improve oxygenation and protect against postoperative pulmonary complications (PPCs),~     especially in obese patients. While anesthesiologists tend to use PEEP higher than in~     non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP~     with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of~     PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.~      The investigators aim to compare a ventilation strategy using higher levels of PEEP with~     recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in~     obese patients at an intermediate-to-high risk for PPCs.~      We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and~     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without~     recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for~     PPC.~   "
69421|NCT02148679|"~     Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or~     attention control for 4 weeks after hospital discharge.~   "
69493|NCT02147743|"~     This randomized controlled study tests an innovative juvenile diversion model that~     integrates evidence-based family therapy.Immediate and longer term effects of the family~     intervention will be compared to Services As Usual with 120 adolescents participating in~     Miami-Dade's Civil Citation Program.~   "
69422|NCT02148666|"~     One of the challenges of stem cell therapy is to understand the fate of the injected stem~     cell. By labelling various stem cells with radioisotopes their fate (homing) can be~     demonstrated. In this study, we will develop and refine the existing techniques of stem cell~     labelling to various subtypes of stem cells namely- freshly aspirated bone marrow cells,~     cryopreserved bone marrow cells, g-csf mobilized peripheral blood stem cells and umbilical~     cord cells. After testing the labelling efficacy and viability, these cells will be injected~     in to the coronary arteries of patients with myocardial infarction who have undergone a~     successful revascularization either by angioplasty or thrombolysis. Homing of stem cells~     will be demonstrated by nuclear scan after the procedure. We are adapting techniques used to~     label cells for detection of infection and bleeding using nuclear scans for in vivo~     scanning. Also we are using Technetium instead of FDG which has very little radioactivity~     allowing us to work with the current cardiac labs with out having to reconstruct the labs~     with special shielding for radioactive compounds. Real benefit of stem cells then can be~     explored after demonstrating the proper homing.~   "
69423|NCT02148653|"~     Main scientific question:~      A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD)~     showed remarkable reductions in cardiometabolic (CM) risk markers compared with a~     well-designed control diet. The study was performed under weight maintenance conditions in~     healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also~     resulted in improved cognitive performance after 4 weeks (Nilsson et al., 2013).~      The present project will further study the preventive potential of MFD, using its unique~     properties for identification of new biomarkers and to evaluate the potential role of~     alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a~     randomized parallel design in an eight-week intervention with the test or control diet,~     respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical~     markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are~     also planned. Associations between the gut microbiota composition and measures of CM risk~     are also included. The project provides unique opportunities to identify mechanisms for the~     metabolic impact of MFD, for further exploitation in innovative food and/or dietary~     concepts.~      Central hypothesis:~      The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions~     allowing for body weight reduction. Expected additional benefits may be recorded as reduced~     values for conventional CM-related parameters, markers of modified gut microbiota~     composition and specific changes in blood metabolite profiles.~      Objectives:~        -  To further improve the effect of MFD on biochemical/anthropometric CM risk markers in~          healthy subjects by administering the diet under conditions allowing for weight~          reduction.~        -  To identify MFD-related changes in the gut microbiota associated with improved CM risk~          markers.~        -  To assess MFD-related modification in metabolic pathways, studied with a metabolomics~          approach, and to correlate them with conventional clinical outcomes, aiming to identify~          new markers of altered metabolic risk.~   "
69424|NCT02148640|"~     The purpose of this study is to assess the safety and efficacy of switching from Remicade to~     the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis,~     psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis~   "
69425|NCT02148627|"~     The main purpose of this study is to evaluate the safety of LY3041658 in healthy~     participants, including first generation Japanese. The study will also investigate how the~     drug is processed and affects key immune cells. Study participation will last 4 months.~      Protocol amended in January, 2016 to include first generation Japanese participants.~   "
69426|NCT02148614|"~     AIMS~      Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and~     metabolic profile.~      Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic~     profile after oral glucose load.~      SUBJECTS~      Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2.~      Subjects will be randomly assigned to treatment with placebo or LibramedR with a double~     blind clinical trial.~      METHODS~      Experimental protocol phase 1~      Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then~     patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given~     a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken~     at 30-minute intervals for the first two hours and 60 minutes for the following two hours,~     for the determination of metabolites and hormones for a total of 4 hours. The level of~     satiety will be quantified through a visual analog scale.~      Experimental protocol phase 2~      Based on the results of the OGTT performed in recruitment phase, children will be divided~     into two groups: group A, children with blood glucose 2 hours after oral load higher than~     the median and group B, children with blood glucose 2 hours after oral load below the~     median.~      The children of group A will be randomly assigned to LibramedR treatment or placebo for 60~     days, after which they will repeat Anthropometric measurements, bioelectrical impedance,~     OGTT and blood chemistry. They will also repeat dietary and sport anamnesis .~      During the 60 days, the children of both groups will receive the same dietary treatment~     consisting of a low-calorie and balanced diet, and recommendations to practice more sport.~      Every 15 days a research assistant will contact the families to reinforce treatment~     adherence.~      EXPECTED RESULTS~      Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose,~     insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo~     treatment;~      Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose~     and insulin secretion after OGTT compared to placebo treatment.~   "
69427|NCT02148601|"~     In the recent past, a deep change in the epidemiology of C. difficile infection has~     occurred, with a rise in its frequency, severity, and mortality. Both the refractoriness of~     the infection to standard therapy and its probability of recurrence have also increased,~     representing a main clinical issue. Fecal microbiota transplantation (FMT) refers to the~     introduction of a liquid filtrate of stools from a healthy donor into the gastrointestinal~     tract of a patient for the treatment of specific diseases. FMT has shown outstanding results~     in the treatment of recurrent C. difficile infection. It can be performed through various~     routes: nasogastric or nasojejunal tube, upper endoscopy, retention enema, colonoscopy. In a~     recent systematic review of studies using FMT for the treatment of recurrent C. difficile~     infection, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema)~     led to the achievement of higher eradication rates than upper delivery (gastroscopy,~     naso-gastric or naso-jejunal tube) (81-86% vs 84-93%, respectively). In a randomized~     clinical trial, Van Nood et al. showed the efficacy of FMT by nasojejunal tube in recurrent~     C. difficile infection. Up to now, data on FMT by lower route come out only by case series~     and case reports.~      The investigators' aim is to compare the efficacy of colonoscopic FMT and standard~     antibiotic therapy for the treatment of C. difficile infection in a randomized clinical~     trial~   "
69428|NCT02148588|"~     Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study~     will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked~     thermal and mechanical responses in CPSP, and assesses the associated local anesthetic~     pharmacokinetics.~   "
69429|NCT02148575|"~     The purpose of this study is to test a psycho-educational intervention, Managing Cancer~     Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative~     care and to facilitate its timely integration into self-management of their breast cancer.~     The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and~     three months following enrollment. The intervention group will receive the MCC, and the~     attention-control group will receive a symptom management toolkit. Participants' family~     caregivers will also be enrolled to provide information on patients' self-management.~     Investigators hypothesize that users of MCC, as compared to attention-control participants,~     will demonstrate improved knowledge, feelings, and behaviors related to self-management of~     their cancer care. This innovative research can help to establish palliative care as a~     mainstay of self-management interventions that target serious illnesses.~   "
69437|NCT02148471|"~     The first aim of this study is to assess oxidative stress and nutritional status in patients~     with elevated liver enzymes who were found to have either simple steatosis (SS) or~     nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by~     measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and~     immunohistochemistry, liver function tests, liver and red blood cell membrane fatty~     composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant~     vitamins and antioxidant power, lipid profile, subject demographics, medical history and~     medication use. The second aim is to detect differences in hepatic gene expression~     (messenger RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS~     or NASH and healthy controls, in addition to determine in patients with non-alcoholic fatty~     liver disease (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3~     PUFA content and gene expression. The third aim is to determine the intestinal microbiome~     (microbial composition and metagenome) in patients with SS or NASH and healthy controls.~   "
69438|NCT02148458|"~     The purpose of this research study is to evaluate the effects of intermittent fasting in~     subjects that are eating a Mediterranean diet or a Western diet. This study is part of~     ongoing research in the prevention and treatment of age-related diseases at Washington~     University School of Medicine.~   "
69439|NCT02148445|"~     Long-term NRT has not been studied in patients with COPD, and smokers in the United States~     with COPD are still asked to choose between immediate quitting or continued smoking. The~     purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT,~     might prove to be a reasonable alternative to the standard approach of asking patients to~     quit immediately. The investigators believe that GMT with long-term NRT will reduce overall~     exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater~     quit rates.~      In this study, 398 smokers with COPD will be randomly assigned to either receive: 1)~     traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT~     (GMT). The SC intervention will be based on a standard approach to smoking cessation,~     including smoking cessation counseling supplemented with combination NRT (a nicotine patch~     plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The~     GMT intervention will consist of counseling, focused on medication adherence and smoking~     reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will~     compare the two treatments based on their effects on smoking cessation, number of cigarettes~     smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms,~     breathing function, and smoking-related hospitalizations or death. The investigators will~     also analyze the data in such a way that will be able to identify which patients are most~     likely to benefit from treatment. This analysis will allow patients to estimate their~     chances of success based on their own personal characteristics and which treatment they~     choose.~      The investigators study addresses research priorities identified in recent smoking cessation~     guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder~     Advisory Committee. This study reflects the interests expressed by smokers in prior surveys~     and addresses the limited reach and effectiveness of traditional approaches to smoking~     cessation. If our GMT approach is effective, our study could change the recommendations~     provided in clinical practice guidelines and change the way that insurance companies pay for~     smoking cessation treatment. GMT could provide an alternative for millions of smokers with~     COPD who are not currently benefiting from traditional approaches to smoking cessation~   "
69440|NCT02148432|"~     Venous thromboembolism(VTE) is the third most common cardiovascular complication among~     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients~     and there had been many efforts to prevent such complication. The American College of Chest~     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE~     prophylaxis.~      This study focuses on how VTE prophylaxis is being performed in both medical and surgical~     ICUs in a single University hospital, and sees the differences in such prophylactic~     patterns.~   "
69441|NCT02148419|"~     Between 2007-2010 the Child Protection Team (CPT) at University Children's Hospital Zurich~     was the first in Europe to follow up the development of maltreated children in a hospital~     sample . The follow-up took place 2-3 years after the child had been reported to the CPT. As~     a major result, children's health-related quality of life (HRQoL) had been impaired in~     maltreated children compared to controls (Jud, Landolt, Tatalias, Lach, & Lips, 2012).~     However, this difference only emerged for the self-assessment of HRQoL by children aged 6~     years or older .To address limitations, the CPT at University Children's Hospital Zurich and~     Children's Hospital Baden AG propose a prospective study with a baseline at the time of~     report to the CPT and a two year follow-up. This study aims at analyzing HRQoL, behavior and~     mental health of maltreated children prospectively and will be the first to provide data on~     changes in HRQoL in the aftermath of maltreatment. We assume the following hypotheses:~        -  The HRQoL and mental health of children will be impaired following maltreatment even~          while controlling for others possible predictors of impaired HRQoL and mental health.~        -  We assume a dose-response relationship between severity of maltreatment and impaired~          HRQoL. Multiple maltreatment is hypothesized to have a larger impact then a single type~          of maltreatment.~        -  At baseline, HRQoL scores are hypothesized to be at a markedly low level. We assume a~          slight increase in HRQoL from baseline to first follow-up, but not a continuing~          increase to second follow-up.~   "
69442|NCT02148406|"~     This randomized pilot clinical trial studies Yoga Skills Training or attention control in~     reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV~     colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing~     practices that aim to promote mindfulness and relaxation. Attention control consists of~     conversations with a caring professional with a recommendation to complete daily home~     diaries. It is not yet known whether Yoga Skills Training is better than attention control~     at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose~     of this initial feasibility study is to refine study procedures.~   "
69443|NCT02148393|"~     A randomised controlled open-label clinical trial to compare the clinical pregnancy rates~     between fresh embryo transfer and elective all-embryo vitrification with thawing and~     transfer in a subsequent cycle in high-responders~   "
69444|NCT02148380|"~     The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS~     and OS of patients with NSCLC. However, outcome of the combination therapy are similar to~     those reported in several trials of single-agent EGFR TKIs. So which is the optimal~     first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators~     need a head-to-head study to reply.~   "
69504|NCT02147600|"~     The main goal of this study is to determine optimal cut-off values of adalimumab trough~     levels corresponding to good clinical response. Determination of these values is necessary~     to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according~     to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary~     objective of this study is to further detect and quantify AAA and to correlate them with~     adalimumab and clinical response in a real life setting cohort of psoriatic patients.~   "
69445|NCT02148367|"~     -  Traumatic brain injury (TBI) is the leading cause of death and disability in people~          under age 45 in industrialized countries. Significant numbers of US veterans from the~          wars in Iraq and Afghanistan return with TBI. However, to date, there are no specific~          neuroprotective treatment options with proven clinical efficacy.~        -  Erythropoietin (EPO) is approved by the FDA to treat anemia and has comprehensive~          preclinical data supporting its neuroprotective and neuroregenerative efficacy~          following traumatic (TBI) and a wide range of other acquired brain insults. Injury to~          small and medium-sized cerebral blood vessels is a well recognized consequence of TBI.~          EPO increases production of endothelial progenitor cells (EPCs) and promotes~          angiogenesis and neovascularization after TBI. EPO also promotes neurogenesis and~          improves functional recovery in animals after experimental stroke and TBI.~          Neovascularization is coupled with neurogenesis, and augmentation of both processes by~          EPO may result in lessened cognitive deficits. Neovascularization by EPO may prevent~          post-traumatic deficits in cerebrovascular reactivity (CVR), which can be measured~          noninvasively using magnetic resonance imaging (MRI).~        -  This proposal is for a randomized, placebo-controlled pilot clinical trial designed to~          obtain data on the effects of EPO in humans with persistent post-concussive symptoms~          after TBI. The primary objective is to evaluate effect of 4 week administration of~          recombinant erythropoietin on numbers of circulating endothelial progenitor cells in~          patients with persistent symptoms during the subacute period after TBI. This~          information will guide the design of a future definitive study.~   "
69446|NCT02148354|"~     The purpose of this study is to determine the differential effectiveness of a self applied~     treatment delivered via Internet for the prevention and treatment of depression, with or~     without support by the therapist, compared to a waiting list control group. The principal~     hypothesis is that the two intervention groups will improve significantly compared to the~     waiting list control group, and without significant differences between them. The~     investigators believe that the support of ICTs may be doing a similar function as the weekly~     support call (to offer feedback, to reinforce, to motivate the participants, etc.).~     Furthermore the investigators hypothesize that the intervention program will be a useful~     tool for a secondary and tertiary prevention of depression.~   "
69447|NCT02148341|"~     This study determines if a community of practice of clinicians and quality improvement~     specialists can be used to implement a national quality initiative known as Hospital to Home~     (H2H). This quality initative is designed to reduced readmission rates for patients with~     heart failure or heart attack by improving the transition of care upon discharge.~   "
69448|NCT02148328|"~     The purpose of this study is to examine the safety and tolerability after administration of~     trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.~   "
69449|NCT02148315|"~     The purpose of this study is to determine whether school gardens affect children's physical~     activity.~   "
69450|NCT02148302|"~     Epidermal grafts are believed to promote healing by two mechanisms: graft take and the~     promotion of wound healing through the delivery of growth factors and the essential elements~     of tissue repair and wound healing.28 This study is intended to establish the superior~     effectiveness of epidermal grafting and multi-layer compression over that of multi-layer~     compression alone, in the treatment of venous leg ulcers.~      Millions of Americans are afflicted with painful, open, draining sores on their lower~     extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of~     circumstances these ulcers require weeks or months to heal. Not uncommonly wound care~     specialists see patients who have suffered for years or faced amputation of the limb as~     their only option to alleviate the pain.~      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,~     roughly half of patients suffering from venous ulcers will require advanced therapy.~     Epidermal grafting has been a reconstructive option for decades; however, to date there has~     not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting~     System permits the harvesting of epidermal blister grafts at the patient's bedside without~     the need for anesthesia. The grafts can be easily transferred to the wound bed. In case~     studies, epidermal grafting appeared to be effective in reducing wound size and accelerating~     closure of venous leg ulcers.~   "
69451|NCT02148289|"~     The acute consumption of dietary nitrate has been shown to improve exercise capacity in~     athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients~     have reduced exercise capacity, The investigators hypothesized that acute nitrate~     consumption, in the form of beetroot juice, might increase incremental shuttle walk test~     (ISWT) distance in COPD subjects.~   "
69452|NCT02148276|"~     This two-phased project will develop a comprehensive, audio computer assisted~     self-administered interview social harm questionnaire (ACASI-SHQ) that will allow~     researchers to more easily identify and monitor social harms experienced by substance~     abusers participating in HIV-related trials. The ACASI-SHQ will (1) reduce the likelihood of~     socially desirable responding, (2) include items with high levels of specificity to increase~     the likelihood of identifying social harms (construct validity), and (3) utilize a~     self-interview format that will increase the likelihood of its adoption by HIV researchers.~     The investigators will then evaluate its feasibility, acceptability, and preliminary utility~     and construct validity in an ongoing HIV-related trial.~   "
69453|NCT02148263|"~     Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is~     common practice for practitioners to educate their patients to gradually increase their~     contact lens wear time over their first few days of use; however, there is no scientific~     basis in the literature for this practice. This study will compare the ocular health and~     comfort of new contact lens wearers who are randomly assigned to begin contact lens wear~     with increasing wearing time versus those who immediately start full-time wear (eight hours~     or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue~     Oasys) for two, four, six, eight, and eight or more hours on the first, second, third,~     fourth, and fifth days, respectively. The other group will be instructed to wear the same~     contact lenses for eight or more hours per day, starting with the first day of wear. Both~     groups of subjects will have their eye health and comfort evaluated at baseline, one, and~     two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily~     log of eye comfort with a visual analog scale survey at home. All subjects will learn how to~     wear and take care of contact lenses. They will also receive a prescription for contact~     lenses at the conclusion if they wish to continue wearing the study contact lenses.~   "
69454|NCT02148250|"~     The purpose of this study is to learn more about how U500 regular insulin can be effectively~     be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take~     U100 insulin, but if they require large doses (such as >150 units a day) they may experience~     pain at this site of injection and the absorption of the insulin is unpredictable, thereby~     leading to poor glucose control. To overcome these problems, doctors sometimes switch to a~     more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as~     U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume.~     However, how to best use U-500 insulin is not certain. The investigators are not really sure~     how long a given dose is effective in patients who require large doses (>150 units of U100~     insulin), so are not sure of how often the drug should be administered. In this study, the~     investigators will determine how effective two different doses of U-500 regular insulin (100~     U and 200 U) are in lowering blood sugar and how long these two doses last. This information~     will help doctors develop better treatment plans for patients with type 2 diabetes.~   "
69455|NCT02148237|"~     This study is to determine preliminary effects of home-based individual breastfeeding~     consultation with and without cash incentives to increase breastfeeding (BF) duration among~     low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for~     Women, Infants, and Children (WIC).~   "
69456|NCT02148224|"~     Glycemic index concept is widely used to determine impact of a food to blood glucose.~     Although the previous studies showed that glycemic index did not seem to be related with~     subject-specific factors, currently several studies found conflicting results on the~     relationship of subjects' characteristics and glycemic index values. This study aims to~     determine whether body composition parameters, as subject-specific factor, correlate with~     glycemic index values.~   "
69457|NCT02148211|"~     The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy~     outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline~     (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval,~     Fluarix Quadrivalent and FluLaval Quadrivalent.~   "
69458|NCT02148198|"~     Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and~     diastolic blood pressure in a cross-over designed study in healthy adults with normal, high~     normal and mild hypertension. Based on results from this study, one dose will be selected~     for a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and~     diastolic blood pressure and endothelial function in a similar population.~   "
69459|NCT02148185|"~     The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303~     in subjects with Crohn's disease.~   "
69460|NCT02148172|"~     While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive~     stability, studies are showing consistently poor long-term outcomes. Unusually high risks of~     early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all~     seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which~     itself may be due to fear of re-injury. Decreased knee bending for force absorption~     simultaneously decreases performance level and increases risk for injury and arthritic~     changes.~      The purpose of the proposed study is to compare a current best-practice plyometric training~     program to one utilizing body weight support to increase repetition and improve performance~     in the initial phases. The investigators hypothesize that we will see larger improvements in~     absorptive capacity of the knee and better confidence in activity immediately following body~     weight support training, as well as improved retention of training effects after a two-month~     period.~   "
69461|NCT02148159|"~     Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid~     weight loss negatively impact on physical functioning, quality of life, and overall~     survival. Patients will be randomly assigned into two groups. An intervention with~     acupuncture may slow down or stop the progression of cancer-related anorexia and weight~     loss.~   "
69462|NCT02148146|"~     This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat~     emulsion in the treatment of liver disease associated with prolonged use of intravenous~     nutrition.~   "
69463|NCT02148133|"~     This is an open-label, non-randomized, phase II study to assess the efficacy and safety of~     eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a~     platelet count <30,000/ microliter who are refractory to anti-thymocyte globulin (ATG)-based~     immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are~     ineligible for ATG-based IST.~      Eltrombopag is expected to improve trilineage blood cells and decrease transfusion frequency~     based on the result from the previous study in patients with severe AA. This study will use~     the hematologic response rate, defined as the proportion of subjects showing improvement in~     at least one of the three blood cell lineages or a decrease in blood transfusion volume, as~     the primary endpoint.~      Twenty patients will be enrolled in the study. Treatment with eltrombopag will be started at~     25 milligram (mg)/day and increased by 25 mg/day every 2 weeks according to the platelet~     count up to 100 mg/day. Response assessment will be performed at 3 months after starting the~     study treatment (Week 13). Subjects in whom the treatment is assessed as effective will be~     continued with the study treatment. Subjects in whom the treatment is assessed as effective~     (when meeting any of the response criteria) at 6 months after starting the study treatment~     (Week 26) may enter the extension phase and continue the treatment with eltrombopag. The~     primary endpoint is the hematologic response rate at Week26.~   "
69464|NCT02148120|"~     The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator~     effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535~     NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic~     patients.~   "
69465|NCT02148107|"~     It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics,~     safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to~     support the further clinical development of this LTA4H-inhibitor. Special emphasis will be~     given to detect potential effects of BI 691751 on heart rate.~   "
69505|NCT02147587|"~     This study will evaluate immune response following administration of zoster vaccine in~     subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5~     mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.~   "
69466|NCT02148094|"~     Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and~     consistent condom use is an effective means of preventing HIV transmission, many FSWs have~     difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs~     who are unable to correctly and consistently use condoms with their clients or regular~     partners. Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this~     critical prevention gap, and a demonstration project is required to assess the impact and~     feasibility of the use of PrEP as an HIV prevention intervention among most at risk FSWs in~     India.~      The proposed project will take place at two sites in India and will assess the use of a risk~     assessment tool to identify FSWs who would most benefit from PrEP, collect information about~     the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery~     strategies (weekly clinic pick-up or home delivery by peer educators every second day),~     monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of~     the use of PrEP in these communities (e.g. reduction of condom use, drug side effects or~     adverse events, social harms or resistance). To ensure the safety of study participants, a~     community advisory board will be set up and will meet regularly to inform study staff of any~     concerns that the community may have related to the study, so that the study staff can~     respond in a timely manner. A data safety and monitoring board will also be established to~     monitor participant safety.~   "
69467|NCT02148081|"~     When children suffer from a critical-illness, the investigators focus on resuscitating and~     saving lives. Once these children leave the pediatric intensive care unit, very little is~     known about what happens to them - how long it takes for them to recover, how families cope,~     and what factors that impede their recovery. The specific objective of this research project~     is to evaluate how children and their families recover after a critical illness.~      Research Hypotheses: Following a critical illness in children, 1) the rate and degree of~     health and functional recovery is influenced by the following factors: age, pre-admission~     co-morbid status, critical illness severity, discharge functional status, and time to~     initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden~     and health-related quality-of-life (HRQoL).~   "
69468|NCT02148068|"~     Obesity is an important public health issue worldwide. In the United States, the percentage~     of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the~     last 40 years. Medically supervised attempts at weight loss are fraught with failures and~     recidivism. Surgical approaches to this important issue are both durable and effective. The~     gold standard approach to the surgical treatment of obesity and the attendant medical~     comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic~     sleeve gastrectomy (LSG). The mechanisms by which these two operations work and the~     associated side effects are not completely understood. It is established that the RYGB~     induces changes in both the fatty tissue mass (FTM) and lean body mass (LBM)~     post-operatively. This is associated with decreases in bone mineral density, basal metabolic~     rate, and potentially the ability to maintain weight loss. There is only incomplete~     information on the influence that the LSG has on body composition. This study proposes an~     evaluation of the changes in body composition that occurs following these two disparate~     operations. Using serial measurements by the BodPod and collecting information on the~     patients' dietary intake, exercise habits and comorbidity resolution, this study will help~     to better define the influence that the LSG has on body composition. It is hypothesized that~     the addition of a malabsorptive component will result in increased speed weight loss and~     overall weight loss which will have a negative impact in the preservation of lean tissue~     mass for the patient. This information can then be used by bariatric surgeons to better~     cater the surgical procedure and post-operative plan to the patient's body make up and~     medical comorbidities.~   "
69469|NCT02148055|"~     Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and~     psychologically painful for the couple and the healthcare team. In this difficult context,~     it is essential to understand the etiology of death to guide the management of subsequent~     pregnancies. Among the investigations, foetopathologic examination is essential, but the~     examination of the brain is not possible in more than half of the cases due to the cerebral~     maceration due to the incompressible delay between death and expulsion.~      The use of MRI as a diagnostic tool fetal post- mortem  virtual autopsy  performed before~     expulsion of the fetus is interesting because it would permit to obtain a macroscopic~     examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a~     normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI~     abnormalities are found , it will not only guide the foetopathologic review, but mainly to~     guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the~     couple would be better than autopsy which is often refused by the couple in this difficult~     psychological context.~      In this study , MRI will be given in addition to conventional autopsy in the painful waiting~     time between the time of diagnosis of death and expulsion without delaying care . If this~     study is validated , MRI may be systematically proposed in this indication or alternative to~     autopsy when it will be refused by the parents.~   "
69470|NCT02148042|"~     Anorexia nervosa is a chronic mental health condition characterized by maladaptive food~     consumption (i.e., hypophagia) and distorted body image. There is substantial evidence of a~     phenotypic overlap between anorexia nervosa and anxiety disorders, as well as data~     suggesting the two share a common genetic pathway. Despite these findings, little research~     has examined fear conditioning among individuals with anorexia nervosa, and no research has~     examined whether individuals with anorexia nervosa have a propensity to overgeneralize~     conditioned fear stimuli, one of the more robust fear-conditioning markers of anxiety~     disorders. The current study assesses generalization of conditioned fear with~     fear-potentiated startle: the cross-species enhancement of the startle reflex when an~     organism is in a state of fear. Animal data, as well as an emerging literature in humans,~     tightly links fear-potentiated startle to the amygdala-based fear circuit. Thus, evidence of~     overgeneralized fear-potentiated startle in anorexia nervosa would link this eating disorder~     to hypersensitivity of the fear circuit and could inform the development of novel~     pharmacologic and psychological treatments for anorexia nervosa based on treatment models~     used in the anxiety disorders literature.~   "
72153|NCT02112942|"~     A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in~     healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be~     evaluated. Antiviral activity will also be assessed in HCV-infected subjects.~   "
69471|NCT02148029|"~     Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs~     progress to chronic post-clot problems resulting in significant disability, loss of~     productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the~     primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence~     of reverse flow. The investigators have observed that clot breakdown is enhanced by~     increased blood flow and that moderate arm and leg exercise result in increased venous blood~     flow. Hence, the investigators predict that a supervised exercise program in patients with~     deep vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease~     the risk of post clot problems. The primary hypothesis is that increased blood flow across~     the clot (induced by supervised exercise) will increase clot breakdown and decrease severity~     of post clot problems. The investigators are conducting a randomized clinical trial of~     standard therapy compared to progressive exercise training in patients with leg deep vein~     clots.~   "
69472|NCT02148016|"~     Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor~     tissue has prevented many patients from regaining vision. Additionally, refractive error~     such as myopia is a major cause of impaired visual function worldwide. Although refractive~     error is correctable by procedures that modify the refractive power of the cornea, these~     procedures often weaken corneal integrity and have risk of complications. This study aims to~     evaluate the safety and efficacy of corneal surface epithelium repair and regeneration in~     the treatment of corneal surface diseases and refractive error using autologous limbal stem~     cell transplantation.~   "
69473|NCT02148003|"~     Chronic lower back pain (CLBP) is a significant health care issue in the United States and~     the world. CLBP contributes to decreased quality of life, decreased function and increased~     utilization of health care resources. The causes of CLBP tend to be multi‐factorial.~     Arthropathy of the lumbar facet joints is thought to be a common etiology (15‐45%).~     Radiofrequency Ablation (RFA) of the medial branch nerve of the facet joint is a~     well‐established treatment modality used to decrease facet joint pains. However, a wide~     range of temperature is being used (70‐90 degrees Celsius). In addition, the optimal~     temperature that provides the best patient outcomes with the least side effects is not well~     established in the pain management literature.~      This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius~     provides more overall pain relief (i.e., percent of improvement), when compared to ablation~     at 80 degrees Celsius with no additional adverse events. Furthermore, ablation of the lumbar~     facets nerve supply at 90 degrees Celsius will provide better improvement in the~     functionality level, general mood and quality of life as measured by VAS ( Visual Analog~     Scale) pain score, Pain Disability Index (PDI), McGill Pain questioner scores and Beck~     Inventory (BI) scores as those receiving the ablation at 80 degrees Celsius. Also, it is~     associated with less opioid consumption, no additional unwanted adverse events and/or~     complications along with less need to repeat RFA procedure over one year period.~   "
69474|NCT02147990|"~     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib.~     The trial is open-ended, which means patients will continue to take rociletinib until the~     study doctor determines it is no longer beneficial for them.~   "
69475|NCT02147977|"~     Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the~     leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is~     estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk~     of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial~     fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often~     asymptomatic, but the risk of stroke increases dramatically and the annual mortality~     doubles. Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is~     expressed by attenuated Heart Rate Variability (HRV) which is a measure of the variation in~     the time interval between heart beats. Attenuated 24 hours HRV is associated with an~     increased risk of sudden cardiac death in the general population and among patients with~     ESRD. N-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been~     shown to increase HRV and reduce the risk of various ventricular and supraventricular~     arrhythmias in some but not all studies, but this effect has only been sparsely investigated~     in the high risk patients with ESRD, who has a very low intake of n-3 PUFAs.~      Objective: The purpose of this study is to investigate the effects of n-3 PUFA~     supplementation on HRV and arrhythmias in dialysis patients.~      Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA~     supplementation reduces the level of Supraventricular tachycardia, premature atrial~     complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients.~      Design: Randomized double-blind, placebo controlled trial~      Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel~     Hospital, Hjørring in Denmark.~      Inclusion time: Summer 2014 to Fall 2015~      Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs~     or placebo (olive oil). The following data are registered at baseline and after 3 months~     treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples,~     48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires~     and blood measurements).~      Perspective: A positive result of this study might make it possible to achieve a reduction~     in arrhythmias and mortality in these high risk patients by a cheap and well tolerated~     nutritional supplement.~   "
69476|NCT02147964|"~     The purpose of this investigational drug study is to determine how much male hormone,~     testosterone, is needed to maintain sperm production in the testis.~   "
69477|NCT02147951|"~     Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to~     IVM1c Melanoma.~   "
69478|NCT02147938|"~     Assessment in a real situation of the conversion conditions, the efficacy and the safety of~     the treatment with tacrolimus in renal transplant patients converted from the tacrolimus~     twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up~     at one year.~      Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early~     (during the first 6 months post-transplantation) or late (between 6 and 12 months~     post-transplantation).~   "
69479|NCT02147925|"~     The aim of this study is to explore the effectiveness of liraglutide combined with metformin~     in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared~     to sitagliptin and insulin glargine in combination with metformin.~   "
69506|NCT02147574|"~     Purpose:~      To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic~     ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with~     STC.~      Methods and techniques:~      The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with~     anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related~     status such as frequency of defecation, course of constipation, laxatives use condition the~     condition of using laxatives, and changes in weight were investigated. Changes of defecation~     and weight, periprocedural complications (wound infection, lung infection and intestinal~     fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction,~     wexner score of pre-operation and postoperation ect were investigated in follow-ups.~   "
69480|NCT02147912|"~     Background:~      Several clinical studies show high rates of anxiety and depressive disorders in Chronic~     Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms~     of COPD and depressive disorders. The aim of this study is to evaluate the effects of~     aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD~     depressed patients without psychopharmacological treatment, through the correlation of some~     psychopathological variables and physical/pneumological parameters.~      Methods:~      The investigators have designed an observational longitudinal trial. The trial will be~     prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on~     depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton~     Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life~     and neurocognitive function.~      Outcome measures:~      The investigators compare the variation of HDRS total score, as primary outcome measure, in~     two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status;~     age; gender. Only the participants randomized in study group A will receive a 6-weeks~     aerobic exercise intervention.~      Statistical analysis:~      All tests are two-tailed and a p value 0.05 was considered significant. The difference~     between the two groups will be evaluated with Student's T test for normally distributed~     data, and with Mann-Whitney's U test, for those with not normal distribution. The normality~     of distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among~     the variables under evaluation will be assessed by Spearman r correlation. Variables will be~     compared using the Chi-squared test or Fisher exact test for categorical variables.~      Discussion:~      There is a strong correlation between physical activity and mental health. Several data have~     suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and~     to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose~     an effective intervention to reduce the risk of severe depression in this special~     population, evaluating the variation of HDRS total score after the aerobic exercise~     intervention.~   "
69481|NCT02147899|"~     The purpose of this research study is to test the safety and effectiveness of the oral~     investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.~   "
69482|NCT02147886|"~     -  This is an exploratory, randomized, parallel-group, dose escalation and dose-controlled~          study without a placebo arm.~        -  Eligible patients will be randomized in a 1:1 ratio (double-blind) to receive Cabaletta~          in 2 doses, once weekly for 22 weeks (total of 24 weeks of treatment).~   "
69483|NCT02147873|"~     This is a randomized double blind placebo controlled study of azacitidine with or without~     birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or~     myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and~     mechanistic studies support that azacitidine may modulate pathways that enable~     birinapant-mediated anti-tumor activity.~   "
69484|NCT02147860|"~     The overall aim of this proposed research is to determine the safety, feasibility and~     efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in~     children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting.~     This will be addressed in two parts: 1) An in residence, outpatient study to determine~     safety and feasibility of the DiAs during 72 continuous hours of day and night glucose~     control; and 2) Camp studies planned for the summer of 2014 with randomization to either~     full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes~     camps.~   "
69485|NCT02147847|"~     Hearing in noisy environments is a perceptual problem that is ubiquitous in modern~     industrialized societies. This particular listening context offers a particular challenge to~     individuals living with hearing impairment (30 million in US alone) even after treatment~     with hearing aids or cochlear implants. The ability of the brain to extract regularities~     from the environment and suppress distracting information can be improved with intensive~     cognitive training. The investigators will test whether the hearing in noise abilities of~     adults living with hearing impairment can be improved with a cognitive training paradigm.~   "
69486|NCT02147834|"~     To determine if ranolazine improves angina symptoms at 4 months compared with placebo among~     patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on~     the Fractional Flow Reserve (FFR) measurement.~   "
69487|NCT02147821|"~     This prospective randomized controlled trial will examine the efficacy of reducing the~     number of chest tubes used in the postoperative cardiac surgery patient. Typically used are~     three chest tubes - two in the mediastinum and one in the pleural space, if opened. The~     investigators propose that removal of the pleural tube will not impact the rates of~     clinically significant pleural effusions post cardiac surgery. Patients will be randomized~     into two groups - one receiving the standard three chest tubes (standard), and the other~     receiving only mediastinal drains (experimental). The primary outcome will be rates of~     post-operative pleural effusions as determined by defined interventions, including insertion~     of a chest tube, thoracentesis, or return to the operating room for primary evacuation of~     pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length~     of mechanical ventilation, postoperative respiratory status, and presence/size of pleural~     effusions, as well as readmission for pleural effusion.~   "
69488|NCT02147808|"~     This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics~     of midazolam in healthy male and female subjects.~   "
69489|NCT02147795|"~     -  This epidemiological trial will determine whether the implementation of a PBM program~          is safe and effective in terms of clinical outcome compared to a pre-implementation~          cohort~        -  Primary endpoint is a composite outcome comprising in-hospital myocardial infarction,~          stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge~          from hospital in patients before and after implementation of the PBM program.~        -  Secondary endpoints are the length of stay on the intensive care unit, total hospital~          stay and the quantitative utilization of allogeneic RBC units, platelet concentrates,~          other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors,~          and cell saver systems during hospital stay.~        -  The primary aim is to prove non-inferiority of the intervention (PBM) group when~          compared with the control group stratified by center.~   "
69490|NCT02147782|"~     Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone~     loss, which is called renal osteodystrophy. Most of the previous studies focused on bone~     metabolism of patients in late stage of chronic renal insufficiency, especially those with~     chronic dialysis. In this study, bone metabolism of patients in different stages of chronic~     renal insufficiency will be observed to reveal the mechanism of development of renal~     osteodystrophy and provide clues for early intervention on renal osteodystrophy.~   "
69491|NCT02147769|"~     Premature infants are at high risk for variations in blood pressure and oxygenation during~     the first few days of life. The immaturity of the premature brain may further predispose~     these infants to death or the development of neurologic problems. The relationship between~     unstable blood pressure and oxygen levels and brain injury has not been well elucidated.~      This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive~     oxygen-measuring device, to identify preterm infants at highest risk for brain injury or~     death.~   "
69494|NCT02147730|"~     Regional anesthesia techniques, with administration of local anesthetics for neuraxial or~     peripheral route are now playing a central role in modern anesthesia and in particular in~     the control of postoperative pain. There are many review and meta-analyzes suggesting that a~     good pain control, and specifically loco regional analgesia, may improve the outcome of~     patients undergoing surgery.~      The control of acute post-operative pain is not the only challenge to be paid by~     anesthesiologists, because there is still much to be understood in relation to persistent~     post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays~     in complete long-term functional recovery of patients.~      From the pathophysiological perspective there is not a precise definition of the mechanisms~     and risk factors that determine the onset of the persistent pain after surgery, but, more in~     general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.~      Regional anesthesia could play a key role, as the main determinant of chronic pain is acute~     post-operative pain. The techniques of regional anesthesia exert a powerful block at the~     peripheral level, potentially preventing the progression of central pain and the persistence~     of stimuli that can reach the central nervous system. In addition, during surgery, these~     techniques can reduce the metabolic alterations and the triggering mechanisms of local and~     systemic pro-inflammatory mediators' release.~      Few perspective studies exist about the influence of regional anesthesia on long-term~     outcome and persistent pain after surgery.~      The objective of the investigators study is to assess in a prospective fashion the role of~     regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence~     after surgical interventions which are mostly associated to pain persistence, and understand~     if regional anesthesia provides advantages in other post-surgical outcomes.~   "
69495|NCT02147717|"~     Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate~     the effect of laser acupuncture in the treatment of perioperative pain during tracheal~     suction after patent ductus arteriosus ligation in preterm infants.~   "
69496|NCT02147704|"~     It has been known that the blood pressure lowering effect of angiotensin receptor~     antagonists (ARBs) and angiotensin converting enzyme (ACE) inhibitors is impaired in~     patients on high sodium intake. There was an enhanced blood pressure lowering effect of ACE~     inhibitor when sodium intake was restricted or diuretics were added.~      The reason is partially explained by sodium sensitivity or low rennin activity in high~     sodium intake. However, the exact mechanism of sodium intake dependency is not clearly~     understood.~      In a recent study, an ARB, candesartan was revealed to have sodium intake dependency,~     showing lower plasma concentration when subjects were on high sodium intake compared to on~     low sodium intake. However, plasma concentration of another ARB, valsartan and an ACE~     inhibitor ramipril was not changed depending on the sodium intake.~      The strongly suggested mechanism is the involvement of transporter P-glycoprotein (Pg-P).~     the function and expression of Pg-P are modified by genetic polymorphism of multidrug~     resistance 1 gene.~      Although the transport mechanism of Fimasartan from gut is not fully understood, it has been~     known that the multidrug resistance 1 is not involved. Thus, the pharmacokinetic and~     pharmacodynamic property of fimasartan is expected not to be affected by the status of~     sodium intake.~      The present study is designed to investigate whether the pharmacokinetic and pharmacodynamic~     property of fimasartan is changed depending on the sodium intake.~   "
69497|NCT02147691|"~     The pilot study will investigate whether combination treatment of Finacea 15% Gel and~     Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in~     treating both the papules/pustules and erythema associated with rosacea.~   "
69498|NCT02147678|"~     To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation~     and cognitive function in elderly patients~   "
69499|NCT02147665|"~     This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control~     of the human cardiovascular system. Hookah smoking is known to transiently increase blood~     pressure and heart rate while decreasing heart rate variability suggesting - but not proving~     - sympathetic mediation. Here the investigators will directly measure the acute effects of~     Hookah smoking on sympathetic nerve activity with microneurography (intraneural~     microelectrodes) and quantify associated regional changes in vasomotor tone.~   "
69500|NCT02147652|"~     Symptoms of agitation include abuse or aggressive behaviour toward self or others,~     appropriate behaviour performed with inappropriate frequency, or behaviours that are~     inappropriate according to social standards. In the later stages of dementia agitation can~     contribute significantly to patient distress and caregiver stress, and has been associated~     with poor quality of life. Previous research studies have shown some evidence that~     personalized music played in daily care situations reduces agitation. The purpose of this~     study is to evaluate the effects of personalized music therapy via headphones on agitation~     during hygiene care (grooming).~      This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto~     Rehabilitation Institute. The study would take place over the span of 2 weeks and would~     involve listening to personalized and either non-personalized or no music during daily~     hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained~     will remain confidential.~   "
69501|NCT02147639|"~     This study is intended to build on a growing body of literature showing a blood flow~     abnormality in patients with Becker muscular dystrophy. The investigators' laboratory~     recently showed that this blood flow abnormality could be corrected by a single oral dose of~     the drug Tadalafil (also known as Cialis). The investigators now wish to replicate these~     exciting results using a common nitric oxide donor (sodium nitrate).~   "
69502|NCT02147626|"~     This study will compare two arms in a randomized clinical trial of cardiovascular risk~     prevention in women with a history of preeclampsia. The first arm will provide postpartum~     patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle~     Recommendations for women with a history of preeclampsia. The second arm will additionally~     receive access to a customized patient-informed online program with modules on how to~     achieve the AHA recommendations for diet, activity and weight management.~   "
69503|NCT02147613|"~     Heart failure is a major health concern and is the leading cause of hospitalization among~     elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and~     the estimated direct and indirect costs of treating heart failure are approximately $37.2~     billion. Approximately 40% of those diagnosed with heart failure will have heart failure~     with preserved ejection fraction (HFPEF). These individuals have significant restrictions in~     their ability to carry out activities of daily living. Exercise training has been~     established as adjuvant therapy in heart failure. Although exercise training guidelines for~     treatment of heart failure with reduced ejection fraction (HFREF) are well established, no~     consensus exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular~     adaptations are generally greater after high-intensity exercise training; interval-type~     exercise facilitates this type of training because it allows for rest periods that make it~     possible for patients with heart failure to perform short (e.g., 1-4 minutes) work periods~     at intensities that are higher than would be possible during continuous exercise.~     High-intensity aerobic interval training presents a unique, yet untested, therapeutic~     modality for the exercise training of patients with heart failure with preserved ejection~     fraction. Pilot testing is warranted, results of which may have important implications for~     reducing cardiovascular risk, increasing short- and long-term quality of life and survival,~     and reducing healthcare costs in this patient population. The investigators primary specific~     aim is to determine the efficacy of a novel, high-intensity aerobic interval exercise~     training program for improving VO2peak (peak oxygen uptake), endothelial function, and~     arterial stiffness in patients with HFPEF. The investigators secondary aim is to determine~     whether the vascular changes are correlated with the changes in VO2peak.~   "
69510|NCT02147522|"~     Study Hypotheses (Ho) and Research Questions (RQ):~        -  Ho1. A Helping Hand (AHH) will significantly improve and sustain patient self-care~          management of depression and concurrent chronic illness management, Patient Assessment~          of Chronic Illness Care (PACIC) and Quality of Life vs UC at 6 and 12 months~          post-baseline.~        -  Ho2. AHH will significantly improve patient depression treatment acceptance/adherence~          and depression symptoms vs UC at 6 and 12 months post-baseline.~        -  RQ1. What is the association between depression symptoms and concurrent chronic illness~          status over time by group?~        -  RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic~          appointment-keeping?~        -  RQ3. Will patient care satisfaction and reported barriers to self-care management vary~          by study group?~        -  RQ4. What factors are identified via qualitative assessments of patients, promotoras,~          Department of Health Services (DHS) medical and social work providers, and DHS~          clinic/organizational leadership regarding satisfaction with, sustainable uptake of,~          and suggested modifications of the AHH promotora delivery model?~        -  RQ5. What potential technology applications would enhance promotoras delivering~          patient-centered self-care training and resource navigation, communicating and~          integrating care with DHS, and disseminating AHH?~   "
69511|NCT02147509|"~     The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic~     bandage contact lenses treating dry eye caused by Sjögren's syndrome.~   "
69512|NCT02147496|"~     The purpose of this study is to examine the effects of fluid dairy products on blood glucose~     and insulin, satiety and energy intake in normal weight and overweight/obese children in the~     age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of~     isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F.~     yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later~     on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and~     tropical punch consumed before and with a pizza meal 60 min later on food intake, blood~     glucose, and appetite hormone response.~   "
69513|NCT02147483|"~     We propose to conduct a pilot study that will examine the utility and mechanisms of~     Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and~     physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR~     diagnostic criteria for alcohol dependence within the past year but have abstained from~     drinking for the last thirty days. MBRP is designed to improve one's ability to~     self-regulate emotions, thoughts and physical states, thus reducing the need to alleviate~     associated discomfort through substance use. Participants assigned to the intervention group~     will receive an 8-week training course of MBRP over a period of nine weeks; participants~     assigned to the Treatment As Usual (TAU) group will continue treatment as usual, which~     includes utilizing their own effective strategies to refrain from alcohol use. All~     participants will be assessed for pretreatment severity of psychological abuse/trauma as~     well as pre and posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms~     of depression and anxiety, emotion regulation/coping). The outcome of treatment will be~     evaluated using a) Timeline Followback drinking data and b) self-report ratings of~     acquisition of MBRP skills (e.g., state/trait mindfulness, acceptance and awareness, and~     perceived stress) and depressive and anxiety symptom severity. We hypothesize that~     participants who receive MBRP training will demonstrate greater acceptance and awareness,~     reduced cravings, and have a lower likelihood of relapse than participants in the TAU group.~     It is also expected that MBRP participants will demonstrate greater improvements on~     psychological measures of depression, anxiety, emotion regulation and coping, and show less~     perceived stress and physiological arousal to stress compared to TAU participants. Finally,~     little is known about which types of individuals are most likely to benefit from MBRP. Thus,~     secondary analyses will help to clarify for whom MBRP may be most effective.~   "
69514|NCT02147470|"~     Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in cirrhotic~     patients and has a one month survival rate of 50% and a 3 month survival rate of 20%. The~     leading theory behind HRS is selective vasoconstriction of renal vasculature in the setting~     of decreased systemic vascular resistance. Patients with liver cirrhosis suffer from a large~     degree of third spacing in the form of peripheral edema and ascites. In addition treatment~     with multiple drugs, including diuretics puts these patients at higher risks of prerenal AKI~     and ischemic acute tubular necrosis (ATN). AKI occurring due to HRS, prerenal AKI and~     ischemic or nephrotoxic ATN have different pathophysiologic mechanisms and are treated~     differently with significantly different outcomes. While renal perfusion is expected to be~     reduced in HRS and prerenal AKI, it is normal or increased in ATN. Prerenal AKI has the most~     favorable prognosis among these pathologies and treatment simply consists of volume~     expansion with blood, albumin, crystalloids or colloids. In clinical practice vasoactive~     agents such as midodrine and octreotide are used to increase the tone of splanchnic vessels~     and to improve renal perfusion. These interventions would not affect renal function in cases~     with ATN. Unfortunately, the diagnostic criteria proposed by the International Club for~     Ascites (ICA) for HRS are not specific and do not always exclude patients with other forms~     of acute kidney injury. Therefore, availability of a simple diagnostic tool for measurement~     of renal blood flow (RBF) at the bedside would be of great value in management of cases with~     cirrhosis of the liver presenting with acute reduction in kidney function. However,~     currently, there are no practical and simple tools available for this purpose.~      Contrast enhanced ultrasonography (CEU) involves the intravenous injection of gas-filled~     microbubbles to enhance the ultrasound image of the organs and mainly to assess tissue~     vascularity and blood flow. We and others have used CEU to assess changes in RBF in response~     to physiologic stimuli and therapeutic interventions. Here we propose a prospective, pilot~     diagnostic study to validate the use of CEU, in assessing RBF in cirrhotic patients with~     AKI, and to assess the utility of CEU to differentiate between causes of AKI in cirrhotic~     patients.~      Our hypothesis is that CEU will show arteriolar vasoconstriction and decreased blood flow in~     the renal cortex in patients with HRS which would not change in response to volume~     expansion. On the contrary, patients with prerenal AKI will have reduced RBF which will~     increase after volume expansion. Finally, those with ATN will not have a reduced RBF at~     baseline.~      We plan to enroll 25 patients with liver cirrhosis and acute kidney injury who are admitted~     to the University of Virginia hospital into the study.~      CEU will be performed on all subjects to measure baseline RBF. CEU will be repeated in all~     subjects within 24 hours after volume expansion with at least 1gm/kg of albumin (up to 100~     gm/day) to assess a potential change. Hourly urine output and serum creatinine will be~     monitored for potential renal response to the volume expansion as part of clinical care. For~     the subgroup of subjects who receive treatment with combination therapy with albumin,~     midodrine, and octreotide (AMO) RBF assessment with CEU will be repeated after at least 48~     hours of receiving this combination. Renal response will be assessed by monitoring urine~     output and serum creatinine monitored as part of clinical care. All subjects will have~     measurements of fractional excretion of sodium (FENa) and urea (FEUrea) and urine microscopy~     as a part of their routine clinical care (work up of AKI). The results of these tests and~     the response to volume expansion will be used to categorize subjects into three categories~     of AKI (HRS, prerenal AKI, ATN). Correlations between RBF and its changes between different~     therapeutic interventions and renal diagnosis will be tested in this study.~   "
69515|NCT02147457|"~     Extreme preterm birth interferes with the development of the cardiovascular system. Both~     macro- as well as microvasculature undergoes extensive, organ specific maturation. Under~     normal fetal conditions, microvascular growth drives renal development and continues until~     34-36 weeks of gestational age, while retinal vascular growth continues until term age.~     Studies show that there is association between low birth weight and cardiovascular~     dysfunction. According to the Barker hypothesis, this is due to nutritional shortage. In~     extreme preterm birth cases, this growth restriction is observed in neonatal life.~      In adult life, this suboptimal growth is associated with impaired renal and (micro)vascular~     function, hypertension, glucose intolerance and cardiovascular disease. According to the~     Brenner hypothesis, disrupted renal development results in hyperfiltration and hypertension,~     a process that subsequently promotes itself and leads to renal impairment. We will~     investigate macro- and microvasculature in different organs, including eye, kidney, heart~     and sublingual mucosa in former preterm infants, now aged 8-13 years old and age-matched~     controls.~      The expectation is that the results of this project will identify risk factors for~     cardiovascular-renal disease in the adult life of former preterm infants compared to the~     controls, while further analysis on mediators in neonatal life of this cardiovascular-renal~     outcome may provide new information on perinatal risk factors.~   "
69516|NCT02147444|"~     The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism,~     namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese~     clinical practice.~   "
69517|NCT02147431|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2~     diabetes.~   "
69518|NCT02147418|"~     Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue;~     soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the~     rise in the United States. Human papillomavirus (HPV) has been recognized in many of these~     cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this~     study, our goal is to develop a new test that can detect certain HPV proteins in the blood~     or saliva to help improve detection of OPSCC.~   "
69526|NCT02147314|"~     This evaluation will evaluate a new system from YOFiMeter, known as YOFiLife Blood Glucose~     Monitoring System with YOFiMeter glucometer. YOFiLife includes a web- based data system~     known as the Web Portal and smart phone apps for the iPhone and Android. The new YOFiMeter~     is similar to other glucometers with the exception of built in test cassettes, lancet~     cassettes with enhanced communications and data reviewing options.~      This evaluation will also collect data from a YSI 2300 Stat Plus Glucose Analyzer reference~     glucometer. The YSI 2300 Stat Plus Glucose Analyzer will be used as the gold standard with~     all results compared to the YSI results.~   "
70110|NCT02139657|"~     This is a single-arm, open-label study of Rabies Immune Globulin (Human),~     Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose~     of this study is to characterize the rabies virus-specific antibody titer after a single~     intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of~     RIG-C.~   "
69519|NCT02147405|"~     Background:~      - Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms~     soon after starting HIV medications. Often these symptoms are caused by immune~     reconstitution inflammatory syndrome (IRIS). Researchers want to study why and how people~     develop IRIS and how best to prevent and treat it.~      Objectives:~      - To learn the causes and effects of IRIS,and how to best manage it.~      Eligibility:~      - Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those~     already taking HIV medicines with symptoms thought to be related to IRIS.~      Design:~        -  Participants not on ART will have screening blood tests for CD4 count, HIV viral load~          and genetic testing.~        -  After the screening blood tests and before starting HIV medicines., participants will~          return for more than 1 visit for the following:~      <TAB><TAB>- review of medical history<TAB>~      <TAB><TAB>- physical and eye exams~      <TAB><TAB>- blood, urine, and tuberculosis (TB) tests~      <TAB><TAB>- electrocardiogram (EKG)~      <TAB><TAB>- chest x-ray~        -  apheresis: a blood drawing procedure where blood is removed from a vein, white blood~          cells are separated and collected, and the rest of the blood is returned to the person~          using another vein~        -  - PET scan - a procedure where a small amount of radioactive material is injected in a~          vein. The participant then lies on a table that slides into a scanner which takes~          images of the body.~      <TAB><TAB>- lymph node biopsy~      <TAB><TAB>- stool collection by swab~        -  After completion of the above, HIV medicines will be started.~        -  Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12~          weeks. Some of the tests above may be repeated.~        -  Participants already on HIV medicines who may have IRIS will be screened over a 4 week~          time period to see if they really are experiencing IRIS. The screening process will~          include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and~          then every 12 weeks.~        -  The study will last 1 year for both groups but may be extended to 2 years (3 additional~          appointments) for some participants.~   "
69520|NCT02147392|"~     Background:~      - A protein called translocator protein may play a role in brain inflammation. Sometimes it~     is present at higher levels in the lungs than in the brain. Researchers want to see if a~     drug called [11C]ER176 can provide an image of this protein in the brain.~      Objective:~      - To test the ability of a drug to image a protein, and test how it is distributed in the~     body.~      Eligibility:~      - Healthy adults over age 18.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will have a PET scan of the brain using [11C]ER176. It will be injected~          through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery~          at the wrist or elbow. Some participants will also have a lung scan.~        -  For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped~          scanner. A plastic mask will be molded to their face and head. They may be wrapped with~          restraining sheets. The scan will last about 120 minutes. Blood may be taken during the~          scan.~        -  Blood and urine will be taken before and after the scan.~        -  During another visit, participants will have an MRI scan of the brain. Participants~          will lie on a table that slides in and out of a metal cylinder. A strong magnetic field~          and radio waves will take pictures of the brain. The scanner makes loud knocking~          noises. Participants will be given earplugs.~        -  Some participants will have only a whole-body PET scan using [11C]ER176.~   "
69521|NCT02147379|"~     This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I~     disorder (manic depression), who are in remission from an episode. Participants who show~     cognitive impairment at baseline will be randomized to receive open-label Lurasidone added~     on to their current medication(s) or continue their usual treatment for 6 weeks.~     Participants will have 3 clinical visits and 2 telephone appointments during the study.~     Given the preliminary evidence for efficacy of Lurasidone in improving cognition in~     schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in~     bipolar patients.~   "
69522|NCT02147366|"~     -  Hypertension is one of the leading risk factors influencing morbidity and mortality.~          There is need for non-pharmacological management for the same. Music is known to reduce~          anxiety and holds promise for non-pharmacological management of hypertension owing to~          low cost, ease of administration and safety. The efficacy of music to reduce blood~          pressure (BP) has not been established. Besides inconsistent findings, earlier studies~          using music are frequently inconclusive from small sample size. The studies have not~          examined the biomarkers of hypertension.~        -  The purpose of this study was to evaluate the effect of Indian Instrumental music on~          pre-hypertensives and stage 1 hypertensives subjects. Non-pharmacological intervention~          improves the quality of life of hypertensives and music may serve as an adjunct therapy~          along with standard management of hypertensives.~   "
69523|NCT02147353|"~     External Genital Warts (EGW) are the most common sexually transmitted disease associated~     with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective~     method of EGW treatment. However, multiple sessions may be required with reported clearance~     rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration~     approved for three times daily application in immunocompetent subjects 18 years and older~     for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by~     sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with~     immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy,~     treating both clinical and sub-clinical lesions. For this study, the investigators used~     sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect~     with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also~     anticipated that the sequential therapy with be safe.~   "
69524|NCT02147340|"~     This study has been designed to describe the use of Remote Patient Management (RPM) systems~     equipped with sensors for the measurement of weight and blood pressure in an Italian health~     care setting, verifying their efficacy and efficiency for the remote management of heart~     failure patients with implantable defibrillators. Moreover, their ease of use and acceptance~     by physician and patient will be assessed.~   "
69525|NCT02147327|"~     Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25~     dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone~     metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal~     low vitamin D level is a well known problem for our country and the level was reported as~     <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low~     socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in~     relation with several neonatal morbidities and maternal complications of pregnancy.~   "
69527|NCT02147301|"~     TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of~     diminishing hepatic tumor burden while patients await transplantation. Without this~     therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ~     allocation.~      The purpose of the study is to determine whether transarterial chemoembolization using~     doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients~     with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.~   "
69528|NCT02147288|"~     The specific aim of this study is to improve post-operative wound care in the morbidly-obese~     body-contouring patient population following massive weight loss undergoing either~     panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall~     reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal~     matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the~     effectiveness of standard closed-suction drains versus the immediate application of~     continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to~     non-compressible drains. Additionally, we aim to demonstrate increases both in~     cost-effectiveness and quality of life in these patients with the use of the NPWT wound care~     apparatus.~      Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound~     complications in comparison with conventional closed suction drains when used in patients~     after massive weight loss undergoing body-contouring procedures (panniculectomies alone and~     formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with~     acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.~      Hypothesis 2 Although initially more costly than traditional closed suction drains, the use~     of continuous negative pressure devices will in the long-term result in lower total health~     care costs in the above-stated patient population due to a decreased need for additional~     procedures and/or clinical management, including surgical interventions, hospital~     admissions, administration of antibiotics, multiple follow-up office visits, and chronic~     wound care.~      Hypothesis 3 Better quality of life is associated with the use of continuous negative~     pressure devices compared to closed suction drains in these patient populations.~   "
69529|NCT02147275|"~     The purpose of this study is to determine whether there is a significant decrease in~     cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and~     their correlation with standard monitoring parameters.~   "
69530|NCT02147262|"~     The main objective of this study is to characterize the inflammatory proteins, gene~     polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to~     gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu~     lato.~   "
69531|NCT02147249|"~     The main objective of this study is to characterize the inflammatory proteins, gene~     polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better~     insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that~     could serve as biomarkers of disease activity.~   "
69532|NCT02147236|"~     To evaluate whether a structured social skills program, called Social Skills Development,is~     superior to a wait list control group on measures of interpersonal interaction. The Social~     Skills Development (SSD) is a 16-week, group intervention that uses activities and peer~     tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum~     Disorders.Following a diagnostic and social skills assessment,children are randomly assigned~     to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered~     SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the~     durability of gains during the first 16 weeks.~   "
69533|NCT02147223|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. The aim of the study is to~     assess sex specific effects of cocoa flavanols on endothelial and vascular function in~     healthy subjects.~   "
69534|NCT02147210|"~     The principal purpose is the study of the regulation of the expression of ephrin-B1 by~     immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy~     (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG~     biopsy will be the experimental reference value.~   "
69535|NCT02147197|"~     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment~     of bleeding associated with uterine fibroids~   "
69536|NCT02147184|"~     Building on findings from animal studies, pediatric clinical trials, epidemiologic research~     in adults, and on preliminary findings from the investigators' laboratory in children and~     adolescents, this project aims to investigate whether selective serotonin reuptake~     inhibitors (SSRIs), a group of widely-used psychotropics, are associated with impaired bone~     mineralization in youths. Establishing such an association is a first step in a process that~     would eventually involve developing preventative interventions. Identifying genetic factors~     that place certain youths at higher risks for this side effect would ultimately allow~     clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the~     field closer towards individualized medicine.~   "
69537|NCT02147171|"~     Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors,~     the light sensitive cells in the retina, degenerate and the rods (responsible for night~     vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in~     the dark which increases the risk of accidents amongst the elderly. Macular pigment (located~     in the photoreceptors)is thought to protect the retina and reduce the risk of age related~     changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in~     AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main~     component of macular pigment) supplementation improves the dark adaptation deficit in AMD~     subjects. Research into the effects of lutein in a normal human has not been previously~     conducted. Since the older population is increasing, our aim is to firstly establish the~     extent of night vision loss (using dark adaptometry) and secondly to examine the possibility~     of slowing down or reversing this loss through lutein supplementation.~   "
69538|NCT02147158|"~     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment~     of bleeding associated with uterine fibroids~   "
69539|NCT02147145|"~     Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis:~     Patient compliance with a GIST surveillance program will be low.~      Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change~     significantly during a surveillance program.~      Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly~     during a surveillance program.~      Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures~     of GIST size.~      Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.~   "
69540|NCT02147132|"~     Smoking prevalence is over 83% in methadone-maintained patients. These patients experience~     significant difficulty quitting, and there is evidence that a majority of~     methadone-maintained patients smoke most of their cigarettes in the 4 hours following~     methadone dosing. The objective is to provide a preliminary test of the ability of two~     pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos,~     to reduce smoking during the 4 hours following methadone dosing.~   "
69541|NCT02147119|"~     The investigators will study Radial artery injury and endothelial function following~     trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post-~     angiography using Optical Coherence Tomography. The participants will also have radial~     endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one~     week, one month and three months post- angiography. Blood will be taken pre and 24 hours~     post angiography for characterisation of endothelial progenitor cell numbers and function.~     The hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated~     dilatation which peaks at 24 hours and recovers at three months. The investigators hope to~     correlate the rate of this recovery with peri-procedural progenitor cell numbers.~   "
69542|NCT02147106|"~     Rationale: Patients with neuroendocrine tumors (NET) have a rare disease. Due to treating~     patients with a neuroendocrine tumor in 'NET knowledge centers' patients often have to~     travel long distances for follow-up visits at the outpatient clinic. Patients whose medical~     condition allows videoconsultation could save time by replacing outpatient clinic visits~     through videoconsultation for receiving follow-up care. Therefore, in this study we aim to~     introduce videoconsultation as a alternative for follow-up outpatient clinic visits in NET~     patients.~      Objective: The primary objective is to assess if use of videoconsultation in follow-up care~     for NET patients is feasible. We hypothesize that videoconsultation is a suitable medium for~     providing follow-up care in NET patients. Secondary objectives are to explore the amount of~     time videoconsultation takes in comparison with outpatient clinic visits and the~     acceptability and satisfaction of physicians and patients with using videoconsultation in~     follow-up care.~      Study design: The present study is a single-centre prospective feasibility study.~      Study population: Adult NET patients under surveillance or treatment of the department~     Medical Oncology at the University Medical Centre Groningen (UMCG) whose medical condition~     allows videoconsultation will be invited to participate.~      Intervention: Patient who give informed consent will participate in the study. Participants~     will receive follow-up care through videoconsultation instead of conventional visits at the~     outpatient clinic.~      Main study parameters/endpoints: The main endpoint is the feasibility of videoconsultation~     for follow-up care in NET patients. We hypothesize that videoconsultation is a suitable~     medium for providing follow-up care.~   "
69543|NCT02147093|"~     A comparative evaluation of a newly marketed multifocal contact lens with a single vision~     contact lens when used with near vision spectacles. The evaluation was to quantify the~     difference between the two test corrections.~   "
69544|NCT02147080|"~     Skin cancer is the most common cancer in the US, with over a million new cases diagnosed~     yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing~     skin cancer risk is the fact that US adolescents have the lowest skin protection rates of~     all age groups and also demonstrate increased exposure to natural and artificial UV~     radiation. Innovative interventions are needed to have an impact on skin cancer risk among~     young people. Unlike previous interventions, our skin cancer risk reduction intervention~     will be tailored (or personalized) to each individual participant and delivered via the~     Internet. The intervention will emphasize appearance concerns, which are known to be the~     primary motivation for UV exposure and lack of skin protection among young adults. This will~     be accomplished in part through the use of personalized facial images showing UV damage as~     well as computerized age progression demonstrations.~      Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet~     designed to increase skin protection and decrease sun exposure behavior among young adults~     at moderate to high risk of developing skin cancer. Participants will be randomized to the~     tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.~      Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type,~     family history of skin cancer), appearance consciousness, and past exposure and protective~     behaviors moderate intervention effects.~      Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk~     perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.~      The goals of future research would be to enhance the tailored intervention, for example, by~     adding additional contacts or Internet technologies or features, disseminate the~     intervention, assess the longevity of effects, and/or adapt the tailored intervention for~     use with other cancer risk behaviors or at risk groups.~   "
69545|NCT02147067|"~     The purpose of this study is to look at the effects of the drug Ranolazine compared to~     Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance~     and ability, and changes in blood flow to the very small arteries of the heart (known as~     coronary microvascular function) in patients who do not have significant blockages in their~     major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina,~     but it may be particularly effective in people with disease in their tiny heart vessels~     (known as coronary microvascular disease).~      This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise~     testing with monitoring of the heart's electrical activity and oxygen consumption (known as~     cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries~     through small hollow tubes placed through the wrist or groin). If severe blockages in the~     main arteries are not found then testing for coronary microvascular function will be~     performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or~     Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary~     exercise test and the coronary angiogram with testing for microvascular function.~   "
69546|NCT02147054|"~     Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many~     patients who ingest organophosphates require ventilation; of these patients approximately~     50% die. Much of the mortality in these ventilated patients is secondary to intermediate~     syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of~     acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess~     acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest~     or prolonged ventilation and its associated complications.~      The investigators believe that blocking these receptors using a neuromuscular blocking agent~     such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome~     and reduce number of intubated days and mortality.~      In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor~     antagonist, will be used to bind to the receptor at the neuromuscular junction and to block~     the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase~     in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is~     eliminated from the body.~   "
69547|NCT02147041|"~     The aim of this study is to examine the therapeutic effect of green tea extract on obese~     women and the correlation analysis between traditional Chinese medicine syndrome and obese~     related hormone peptides.~   "
69548|NCT02147028|"~     The purpose of this study is to evaluate whether sparing the hippocampi during whole brain~     radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain~     metastases from a systemic tumour helps preserve brain function.~   "
69550|NCT02147002|"~     The National Register of Nephrology in 2007 shows, similarly to the European data, a problem~     of a high mortality rate among Polish dialysis patients.~      The main reason of death among chronically dialysis patients are cardio - vascular system~     diseases. According to The Report on the Condition of Renal Replacement Therapy in Poland~     in 2007, these diseases are the cause of 53% deaths in Poland. The patients with chronic~     kidney disease (PChN) are particularly at risk of cardio - vascular complications. These~     complications occur on average 30 times more often than in the whole population, and among~     young dialysis people, these complications occur 300 times more often. In the development of~     cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic~     acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of~     polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of~     phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is~     dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and~     lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is~     responsible for antiplatelet effect.~      This project is aiming at defining and elaborating on the connection between Omega-3 acids,~     and cardiovascular complications, their influence on the functioning of the cardiovascular~     system, and moreover, a better understanding of the effects of therapeutic and~     pharmacological therapies in patients at different stages of chronic kidney disease.~     Carrying out this project will be a good start to shape an international project in this~     area.~   "
69551|NCT02146989|"~     Rationale:~      Children with Cerebral Palsy (CP) experience limitations in motor activities and~     participation in the community, predominantly caused by impairments in muscle function.~     Aside from abnormal posturing due to spasticity, muscle weakness can significantly~     contribute to impaired muscle function and there is increasing evidence that muscle weakness~     significantly impairs upper limb motor function and ability to perform manual tasks in~     children with CP. Studies in the last decade have shown that muscle weakness, not~     spasticity, is the greatest limiting factor of motor function in children with CP.~     Furthermore, there is increasing evidence that the strength in the upper extremities of~     children with CP is less compared to their typically developing peers (TDP). A systematic~     review focused on the psychometric properties of strength measurement instruments has shown~     that the number of studies investigating psychometric properties of strength measurement~     instruments is limited and that the methodological quality of these studies is low.~      Aim:~      The present study aims to investigate the reproducibility of the following three isometric~     strength measurements in the upper extremity of children and adolescents with unilateral CP~     as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link~     system and functional strength. To study to which extent upper extremity strength, both in~     the affected side and the non-affected side, differs from the strength in the upper~     extremities of TDP, these measurements will also be performed by children without~     neurological problems.~      Study Design:~      A cross-sectional study in which the reproducibility of three strength measurement~     instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and~     adolescents with unilateral CP and TDP.~      Population:~      Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),~     aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are~     mentally able to perform the measurements will be included and TDP.~      Outcome measures:~      The most important psychometric property in strength measurement instruments is~     reproducibility. Reproducibility will be investigated using the following factors:~     Intraclass Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of~     Measurement (SEM) and the Smallest Detectable Difference (SDD). Reference values will be~     determined using the Generalised Additive Models for Location, Scale, and Shape (GAMLSS)~     method.~   "
69552|NCT02146976|"~     The investigators designed a study to determine whether Propofol or Sevoflurane would~     provide same postoperative sleep quality in patients undergoing thyroidectomy.~   "
69553|NCT02146963|"~     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum~     Levels Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.~      The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects~     with alcohol dependence according to their alcohol consumption status 6 months after~     withdrawal (relapse or abstinence), in relation to the presence of psychiatric~     co-morbidities.~   "
69554|NCT02146950|"~     This study is designed to investigate whether LCS12 is associated with an increased risk of~     unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among~     new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy,~     uterine perforation, and PID) associated with the use of LCS12 compared with the established~     hormonal IUD Mirena, and compared with established copper IUDs during standard clinical~     practice. In addition, drug utilization patterns will be described.~   "
69555|NCT02146937|"~     This is an open label, single site, single arm Phase II study to evaluate the combination of~     bicalutamide plus finasteride in men with MRI detectable significant prostate nodules~     followed on active surveillance.~   "
69556|NCT02146924|"~     This phase I trial studies the side effects and best dose of cellular immunotherapy in~     treating patients with high-risk acute lymphoblastic leukemia. Placing a modified gene into~     white blood cells may help the body build an immune response to kill cancer cells.~   "
69557|NCT02146911|"~     Clinically proven medications such as nicotine replacement therapy, bupropion and~     varenicline are available to help smokers quit but there are not widely used. The primary~     objective of this study is to evaluate the real-world long-term effectiveness of of~     bupropion and varenicline treatment in a community sample of smokers interested in quitting.~     The investigators hypothesize that varenicline treatment will result in higher quit rates at~     end of treatment and at one year after treatment compared to bupropion. Smoking status will~     be biochemically confirmed at various time points using salivary cotinine measures.~     Furthermore, since 50% of the variation in quit success is genetically determined, and the~     effectiveness of different cessation medication may differ considerably in sub-groups of~     smokers carrying certain genetic variants, the investigators will collect saliva samples~     from consenting participants to evaluate the moderating effect of genetics on treatment~     response.~   "
69558|NCT02146898|"~     The investigators intend to study the impact of patient positioning on the changes in blood~     pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that~     the changes in blood pressure relate to the speed with which the spinal medication rises. By~     slowing the rise of spinal anesthesia, the investigators believe that the incidence and~     severity of hypotension might be reduced.~   "
69559|NCT02146885|"~     The first step in any clinical intervention against obesity involves sustained lifestyle~     changes. Researcher can use these strategies to beneficial the effects of weight and on~     cardiovascular risk. The researcher develope methods for assessing the effectiveness use~     optical technology to make such assessments, specifically in the area of fatty tissue can~     predict the effectiveness of the intervention in causing weight reduction and treating~     metabolic disease.~   "
70630|NCT02132871|"~     The primary purpose of this study is to investigate wether the measure of stroke volume (SV)~     variations by impedance cardiography during passive leg raising (PLR) can reliably predict~     preload dependency after cardiac surgery, in comparison to a reference parameter : velocity~     time integral (VTI) variation measured by transthoracical echocardiography.~   "
69560|NCT02146872|"~     Since finishing the sequencing of the human genome in 2003, genetic research in coronary~     artery disease (CAD) and other complex traits have developed dramatically. Recent~     genome-wide association studies have identified a considerable number of common genetic~     variants each associated with the disease. This has led to a new understanding but also to~     the discovery of new therapeutical targets. However, each of the variants discovered only~     have minor effects on disease development and even the pooling of the variants only explains~     a minor percentage of the total heritability. It has been evident that rare or private~     mutations probably play a great role in the genetic architecture of CAD, especially among~     young and severely affected patients. These may only be identified by sequencing. Therefore,~     the investigators hypothesize, that the use of exome sequencing (the read-off of the entire~     protein-coding regions of the genome) and linkage analysis in families of extreme phenotype~     cases, will identify disease-causing genetic variants. From the West Denmark Heart Registry~     the investigators will enroll a minimum of 120 patients with atherosclerosis who have~     undergone a coronary artery revascularization procedure before the age of 40, to participate~     in study part 1. A pedigree analysis will be performed and cardiovascular (CVD) risk factors~     and current preventive treatment will be evaluated. 1. degree relatives aged 30-65 years,~     who are free of CAD, are invited to participate in study 2. CVD risk factors are evaluated~     as well as a CT coronary angiogram is performed to quantify the degree of asymptomatic~     coronary atherosclerosis. Families from study 1 and 2, who are considered severely affected~     by atherosclerosis, evaluated on a basis of family size, number of affected and severity of~     disease, will be selected for exome sequencing. Other relevant family members will be~     included as well as their CVD risk factors will be evaluated. Exome sequencing will be~     performed and variants found will be filtered on a basis of frequency, linkage analysis,~     gene position, existing knowledge and in-silico prediction tools. Possible findings will be~     validated by Sanger-sequencing and causality of new variants will subsequently be sought to~     be proven by relevant experimental studies.~   "
69561|NCT02146859|"~     Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are~     frequently used for facilitate tracheal intubation and keep patient still and relax during~     surgery. Unfortunately, residual neuromuscular blockade are important complication.~      There are many factors that affect neuromuscular blockade and may prolong effect of NMBAs~     which we already know about that such as body temperature, drugs, some kind of diseases.~     However there are no recent studies that mention about other factors. The purpose of this~     study is to find out other factors that affect NMBAs effect to improve patient safety.~      Methods The study is a prospective, non-randomized, blinded, observational study.~      222 patients will be included in this study and will be performed general anesthesia.~     Anesthetic technique and agent which are used depend on regular staff. Information of~     patient will be collected are age, sex, weight, height, ASA classification, anesthetic~     technique, anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount~     of opioids and reversal agents.~      After anesthesia finish, patient will be brought to recovery room and Train Of Four watch®~     will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio <~     0.9 will be defined as there is residual neuromuscular blockade in this patient.~      All patients will be divided into 2 groups: residual blockade group(patient who have train~     of four <0.9 after surgery) and no residual blockade group(patient who have train of four~     >0.9). All factor of each group will be compared between. Statistical will be analyzed to~     find significant factor which affect neuromuscular blockade.~   "
69562|NCT02146846|"~     The purpose of this study is to determine population Pharmacokinetics and differences and~     variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in~     treatment of chronic myeloid leukemia patients in Iranian population.~   "
69563|NCT02146833|"~     This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear~     Export (SINE) Selinexor (KPT-330) in patients with metastatic castration-resistant prostate~     cancer (mCRPC).~   "
69564|NCT02146820|"~     The purpose of this study is to determine whether Pico laser is effective and safe in the~     treatment of benign pigmented lesions.~   "
69565|NCT02146807|"~     The purpose of this study is to determine whether Pico laser is effective and safe in the~     treatment of unwanted tattoos.~   "
69566|NCT02146794|"~     Renal denervation can be carried out for heart failure~   "
69567|NCT02146781|"~     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is~     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is~     tolerated and how research participants respond to the vaccine using a different route of~     administration, the Intradermal (ID) route. CryJ2-DNA-LAMP Plasmid vaccine is~     investigational, which means it is not approved for use by the United States Food and Drug~     Administration (FDA) but is available in research studies like this one.~      The study is a Phase IC study to assess and evaluate the safety and immunological responses~     to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid~     vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered~     every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified~     by skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1:~     composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only~     receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic~     subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector~     2000 device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four~     (4) dose regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1~     study center. Subjects are enrolled in the trial for a period of 132 days. The objectives of~     the statistical analyses are to establish the safety and to explore the immunogenicity of~     the LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route.~     All statistical analyses conducted on the data from this trial will be exploratory in~     nature.~      The primary objective of this Phase IC Study is to evaluate the safety and immunological~     responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine~     delivered intradermally (ID) using the Biojector 2000 device.~   "
69568|NCT02146768|"~     Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and~     effectively direct the trans-catheter heart valve (THV) size selection by providing accurate~     annulus sizing, and provide adequate pre-procedural risk-stratification guidance for~     TAVR/TAVI.~   "
69569|NCT02146755|"~     Aortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It~     is characterized by years to decades of slow progression followed by rapid clinical~     deterioration and a high death rate once symptoms develop. The onset of symptoms confers a~     poor prognosis: patients die within an average of five years after the onset of angina,~     three years after the onset of syncope, and two years after the onset of heart failure~     symptoms. The overall mortality rate is 75% at three years without surgery. Drug therapy for~     it remains ineffective, and aortic valve replacement is the only recommended long-term~     treatment.~   "
69570|NCT02146742|"~     Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to~     assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and~     distributed through the body.~   "
69609|NCT02146235|"~     The investigators combine traditional medical care with an integrative modality - Music~     Therapy specifically including wind playing, singing, and music visualizations- to study the~     effects on physical function and quality of life for adults with COPD. The primary goals are~     to increase respiratory function and reduce respiratory symptoms and hospitalizations in~     order to improve breathing, functional capacity for activities of daily living,~     psychological well-being and quality of life in adult age 45 and above who are diagnosed~     with COPD~   "
72759|NCT02104973|"~     The purpose of this study is to design, implement and evaluate an intervention oriented to~     change alimentary practices and patterns of physical activity of children through educative~     activities with parents, teachers and children in school of Mexico city.~   "
69571|NCT02146729|"~     In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack~     of evidence demonstrating similar outcomes between patients treated with percutaneous~     pedicle screws and those treated openly. It has been demonstrated that percutaneous pedicle~     screw fixation has fared well for patients in the short term; however, it is unclear whether~     the outcomes are equivalent or inferior/superior compared to open treatment.~      The authors seek to establish a high-level evidence base to determine clinical patient~     outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing~     thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open~     treatment, and brace treatment. Additionally, the authors seek to establish data relating to~     patient occupational data, complications, and need for further surgery (revision/removal of~     hardware), as well as short-term variables relating to hospital visit (length of stay,~     estimated blood loss, time under fluoroscopy).~   "
69572|NCT02146716|"~     The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous~     Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to~     measure the benzodiazepine amount prescribed during the withdrawal time.~   "
69573|NCT02146703|"~     This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy~     in patient with advanced biliary tract cancer~   "
69574|NCT02146690|"~     The aim of the present 3 armed placebo control parallel group randomized control trial is to~     explore the extent to which osteopathic manipulative treatment is effective in reducing pain~     in a population of complicated newborns.~   "
69575|NCT02146677|"~     Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns.~     Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs~     (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso~     2011). Moreover it was reported the absence of adverse events and side effects considering~     the approach safe (Cerritelli 2013, 2014).~      OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was~     published addressing acute and chronic pain in different medical conditions. However, no~     trials were carried out on pain in newborns. The aim of the present clinical trial is to~     explore the effectiveness of OMT in reducing pain in a sample of preterm infants.~   "
69576|NCT02146664|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled study of~     DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without~     early coronary revascularization. It is hypothesized that the combination of DLBS1033 with~     aspirin and clopidogrel will result in greater reduction of infarct size in comparison with~     that of aspirin and clopidogrel alone.~   "
69577|NCT02146651|"~     The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the~     duration of action of insulin lispro due to facilitation of the absorption of the insulin~     after subcutaneous injection.~      The aim of the trial is to investigate the dose-response and the dose-exposure relationships~     of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and~     glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and~     to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.~      This is a double-blinded, randomised, four-period crossover phase 2 trial using automated~     12-hour euglycemic clamps in subject with type 1 diabetes mellitus.~      Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of~     three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose~     of Humalog® (0.2 U/Kg) on 4 separate dosing visits.~   "
69578|NCT02146638|"~     Aim of this study is to compare benefits and disadvantages in using continuous infusion of~     morphine or fentanyl for post operative analgesia.~   "
69579|NCT02146625|"~     The objectives of this study are:~        -  To evaluate the safety and tolerability of CJ-40002 after single SC injection in~          healthy male volunteers.~        -  To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.~        -  To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.~        -  To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.~   "
69580|NCT02146612|"~     The present study aims to evaluate the patient profile including medical conditions who use~     a nutritional supplement along with a balanced and varied diet in Turkey.~   "
69581|NCT02146599|"~     The purpose of this study is to evaluate the visual quality and function of pseudophakic~     patients.~   "
69582|NCT02146586|"~     This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed~     to be implemented across all sites participating in the Cooperative International~     Neuromuscular Research Group (CINRG) research studies. The study will determine if the~     selected techniques are reliable and reproducible across the CINRG network by evaluating the~     reliability and reproducibility of the measures between CEs~   "
69583|NCT02146573|"~     This study will implement and evaluate the effects of a pediatric continuity care~     intensivist program. This study will determine the impact of an additional pediatric~     intensive care unit (PICU) intensivist on outcomes at the patient and family level. It will~     also evaluate the training program to prepare the continuity care intensivist (CCI).~   "
69584|NCT02146560|"~     Background to main study question: Cardiac complications are a common cause of morbidity~     after non-cardiac surgery. Patients with perioperative myocardial injury (both MI, and lower~     levels of cardiac troponin elevation) experience higher short-term and long-term mortality.~     They are also at substantially increased risk of additional cardiac and non-cardiac~     complications. It is therefore plausible that myocardial injury adversely affects quality of~     life. This study will compare postoperative health-related quality of life of patients who~     did or did not experience perioperative myocardial injury (defined by troponin-I >~     0.07ng/ml) after non-cardiac surgery~      Study Design: Pilot prospective cohort study (n = 300). Population: Consecutive patients~     undergoing non-cardiac, non-transplant surgery at UHN.~      Background to secondary study questions:~        1. Clinically based risk stratification tools used in non-cardiac surgery (e.g., Revised~          Cardiac Risk Index) are of moderate utility and assign patients only to broad risk~          categories. This study will examine the usefulness of pre-operative biomarkers (BNP,~          HbA1c, and others) in supporting cardiac risk stratification and will address the~          question: Is there a set of preoperative criteria that can accurately inform the~          decision to monitor troponin postoperatively?~        2. Intra-operative physiological derangement measured with the Surgical Apgar Score~          correlates with morbidity and mortality 3-months postoperatively. This study will~          examine the relationship between the Surgical Apgar Score; continuous non-invasively~          monitored intraoperative metrics of hemoglobin concentration and occult hypovolemia~          (Pleth Variability Index) with the Masimo Radical-7 Pulse Co-Oximeter; and the primary~          and secondary outcomes. This aspect of the study will address the question: Can readily~          available intraoperative physiological data inform the decision to monitor troponin~          postoperatively?~        3. Quality of Recovery-40 Score evaluates (in the recovery room and at 24 hours~          postoperatively) the patient's subjective experience of their recovery from surgery.~          This metric is correlated with quality of life 3-months postop. This study will~          evaluate correlation between Quality of Recovery-15 Score, a valid and more efficient~          means of measuring recovery, and the primary and secondary outcomes.~        4. Approximately 2/3 of patients who have postoperative myocardial injury are asymptomatic~          and have no ECG changes. Diagnosis of MI requires biomarker elevation (Troponin >~          0.3ng/ml) plus clinical or ECG or imaging evidence of myocardial injury. Of the latter~          3 criteria, 2 are often absent. In selected patients, this study will use~          trans-thoracic echocardiography, CT coronary angiography, and cardiac MRI to improve~          diagnostic yield and define those diagnostic modalities that are most useful in the~          postoperative patient.~      Rationale:~      Postoperative myocardial injury may negatively impact health-related quality of life.~     Affected patients may experience higher levels of postoperative dependency. This possibility~     has implications for patient rehabilitation, provincial and personal healthcare costs, as~     well as patients' physical, emotional and mental well-being and relationships. The public~     health dimension of this problem could therefore be significant. In addition, an incomplete~     understanding exists of how individual patient cardiac risk factors, in combination with the~     perioperative environment, result in myocardial injury. The diagnostic investigations that~     are most useful in this setting have not yet been clearly defined. Patients who fail to be~     rescued after experiencing postoperative complications (as distinct from failure to avoid~     experiencing the complication in the first instance) plays a central role in postoperative~     mortality. Early recognition of such patients is therefore crucial. By prospectively~     observing a cohort of high-risk surgical patients, this study will provide insight into how~     these factors interact. This will allow us to better characterize the potential predictors~     and features of postoperative myocardial injury. We hope that our findings will aid in the~     identification of patient characteristics associated with increased risks of postoperative~     myocardial injury, thus helping to direct diagnosis, early treatment and rescue. This study~     will thus potentially yield important data that will positively impact future patient care~     and the rational use of healthcare resources.~   "
69585|NCT02146547|"~     Schizophrenia is a chronic psychiatric illness with periods of remission and relapse.~     Patients vary in the frequency and severity of relapse, time until relapse and time in~     remission. Discontinuation of antipsychotic medication is by far the most important reason~     for relapse. A possible method to optimize medication adherence is to treat patients with~     long-term, depot medication rather than oral medication. However, despite its apparent~     common sense this approach has neither been universally accepted by practicing~     psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we~     aim to investigate possible advantages of depot medication over oral antipsychotics in an~     independently designed and conducted, randomized, pragmatic trial.~   "
69703|NCT02145013|"~     According to the BCLC guidelines, surgical resection of hepatocellular carcinoma~     complicating cirrhosis is restricted to patients with preserved liver function, single~     nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.~      However, other guideline treatment, especially from eastern countries demonstrated that~     surgical resection is safe and feasible and provides better survival than the treatment~     recommended by the BCLC system for patients with similar stage.~      The primary goal of this study is to assess the impact of HVPG on short and long-term~     outcomes in HCC patients who undergo liver resection.~   "
69586|NCT02146534|"~     Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with~     MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the~     NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks~     (total of 18 sessions).~      Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as~     per label, and the other half will receive a placebo BID.~      All patients will continue to take their medication (fampridine or placebo) during a~     subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and~     14 weeks.~      Study Objectives:~      Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID~     will show greater benefit from active motor training as compared with subjects treated with~     placebo in terms of incidence of responders, degree of response, and duration of response.~      Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg~     BID will show greater benefit from active motor training as compared with subjects treated~     with placebo in terms of quality of life measures.~   "
69587|NCT02146521|"~     The purpose of the study is to compare the diagnosis and management (treatment and~     disposition) of adult emergency department patients with acute nontraumatic abdominal pain~     and tenderness, based on two CT techniques:~        1. Standard (complete) abdominal-pelvic CT. The American College of Radiology calls for~          the cephalad limit of abdominal CT to begin at the dome of the diaphragm, and the~          caudad limit of pelvic CT to extend through the ischial tuberosities.~        2. A z-axis restricted subset of images digitally obtained from the original CT dataset,~          determined by the region of tenderness identified by the examining emergency physician~          and marked on the patient prior to the performance of the CT. This z-axis restricted CT~          does not require any additional radiation exposure to the patient, as it will be~          produced by computer extraction of data from the original standard abdominal-pelvic CT.~      The investigators hypothesize that the diagnosis and management will not differ when guided~     by the two CT scan interpretations. Radiation doses will be calculated for each of the two~     techniques.~   "
69588|NCT02146508|"~     Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal~     squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic~     removal or ablation of ESD in order to prevent development of esophageal cancer.~   "
69589|NCT02146495|"~     Fibromyalgia is a clinical syndrome characterized by extensive chronic pain. Today, the main~     theory argues the origin of the pain is central sensitization which is en amplification of~     processing and transferring neuronal signals. Patients usually suffers a wide range of~     symptoms: extensive pain, chronic fatigue disorders of sleep (having trouble falling asleep,~     fragmented sleep and early awakening) , mood disorders and cognitive damage. To treat the~     sleep disorder, the pain and the depuration with Fibromyalgia patients is a complex clinical~     challenge that usually requires combination of different medicines (short term analgesic +~     long term analgesics + anti-depressives and so on). Patients are also referred to other~     treatments such as cognitive behavioral therapy (CBT), occupational therapy treatment,~     phycisal therapy, alternative medicine and so on.~      Another such non-medical treatment is to try and modifies the patterns of activity of the~     patient's brain. One approach that draws attention in the last few years is EEG based~     neuro-feedback (NF). EEG NF is a closed circuit brain computer Interface (BCI) in which the~     patient gets a feedback from his or her own brain that signifies a certain mental state. The~     brain-patient feedback allows to train patients in performing a voluntary change of a~     dedicated brain area, such as pain related areas. In this study we intend to assess the~     effect of two different EEG-NF protocols targeting different brain areas as compared to~     placebo (sham) NF and drug therapy on pain and sleep quality measures in fibromyalgia~     patients.~   "
69590|NCT02146482|"~     The purpose of the study is to evaluate the changes in back pain from access to a sit-stand~     workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We~     hypothesize that access to a sit-stand workstation will allow one to experience postural~     variation and reduce back pain.~   "
69591|NCT02146469|"~     The objective of the study is as follows:~        1. To know the antibody level during different interval after received 1 dose varicella~          vaccine.~        2. To know safety and effectiveness of received 2 doses varicella vaccine with different~          interval.~        3. To know safety and effectiveness of received varicella vaccine and MMR at the same~          time.~      To achieve that, this study selects children with specific varicella vaccine history, gives~     1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after~     vaccination.~      All blood specimens will be tested by a third-party detection institution.~   "
69592|NCT02146456|"~     Colloid solution is generally used to maintain intravascular volume. It is reported to~     impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging~     coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for~     fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances~     fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction.~      Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of~     plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule~     responsible for the degradation of fibrin, a protein that forms the framework of blood clot.~     It is used to treat or prevent excessive blood loss during surgery and in other medical~     conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity~     reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic~     acid.~      We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration~     can improve the colloid-induced clot strength impairment.~   "
69610|NCT02146222|"~     This partially randomized phase I trial studies the side effects and how well sequential~     dosing of vascular endothelial growth factor receptor (VEGFR)/platelet derived growth factor~     receptor (PDGFR) dual kinase inhibitor X-82 and docetaxel works in treating patients with~     solid tumors. VEGFR/PDGFR dual kinase inhibitor X-82 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     VEGFR/PDGFR dual kinase inhibitor X-82 and docetaxel one at a time instead of concurrently~     may work in treating patients with solid tumors.~   "
69593|NCT02146443|"~     The purpose of this study is to measure test-retest reliability and validate the star shaped~     test of manual dexterity. The purpose of this is to see if there is any significant learning~     effect, and if the test can discriminate between individuals who are at their normal skill~     level, and when they are stressed and/or fatigued. The test is designed to test hand to eye~     coordination and precision control. This is done by following a star shaped track with a~     pair of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter~     clockwise. Each time the scissors come into contact with the border of the track, an error~     is counted. Overall completion time is recorded. As a randomized crossover study, we will~     have 20 test subjects complete the test 4 times. Each test will be conducted with a pause of~     two breaks between the tests. Before each test, the test subjects are randomized to: no~     intervention, physical fatigue prior to testing, distractions during the test or both~     physical fatigue prior to testing and distractions during the test. All participants will~     complete a test with all four interventions. Furthermore, a test-retest trial will be~     conducted on 4 test-subjects. Each subject will complete the test two times with no~     interventions, with two days apart.~   "
69594|NCT02146430|"~     DS 5565 will be better than placebo (sugar pill without active drug) in managing~     fibromyalgia pain and will be well tolerated.~   "
69595|NCT02146417|"~     As both patients with end-stage kidney disease and society benefit tremendously from live~     kidney donation, the safety and well-being of kidney donors are highly important objectives~     in live kidney donation. Laparoscopic donor nephrectomy has several advantages over open~     nephrectomy, such as less post-operative pain, better quality of life and shorter hospital~     stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most~     countries.~      So far, modifications of the technique of laparoscopic donor nephrectomy, i.e. hand-assisted~     and/or retroperitoneoscopic approaches, did not show a significant benefit with regard to~     safety as reflected by the conversion to open and postoperative complications rate. We~     therefore believe that further research should focus on the optimization of early~     postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory~     drugs are contra-indicated before and after nephrectomy, the management of postoperative~     pain largely depends on the administration of opioids. Measures to reduce postoperative pain~     would also reduce the occurrence of postoperative nausea and vomitus, and postoperative~     bowel dysfunction.~      A recent pilot study performed by our group showed that the use of low pressure~     pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred~     pain score during the first 72 hours after surgery. Previous studies performed by others~     show that low pressure pneumoperitoneum is associated with reduction of systemic~     inflammatory response, post-operative pain and analgesic consumption. Martini et al have~     shown that deep neuromuscular block improves surgical conditions during laparoscopic surgery~     with standard intra-abdominal pressure. To facilitate the use of low pressure~     pneumoperitoneum, deep neuromuscular block improves surgical conditions and might become a~     prerequisite for the use of low pressure pneumoperitoneum.~      Our hypothesis is that the combination of low pressure pneumoperitoneum and deep~     neuromuscular block improves quality of recovery in the early post-operative phase.~   "
69596|NCT02146404|"~     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people~     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of~     habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia~     unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent~     evidence suggest a pivotal role for increased brain lactate transport capacity in the~     pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude~     of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing~     alternative energy source or acts as a metabolic regulator controlling brain glucose~     metabolism, oxygen consumption and cerebral blood flow.~      Objective: The primary objective of this study is to investigate the effect of hypoglycemia~     on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary~     objective is to assess whether this effect is a related to hypoglycemia unawareness or a~     consequence of T1DM per se.~      Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport~     over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate~     accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical~     hypoglycemia unawareness. Furthermore, the investigators expect that this effect of~     hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow~     (CBF).~   "
69597|NCT02146391|"~     This study is an open-label, randomized, single-center, single-dose, two-way crossover study~     of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each~     receive a single dose of Androxal 25 mg in both the fed and fasting state.~   "
69598|NCT02146378|"~     The purpose of this study is to understand safety (e.g., occurrence of adverse drug~     reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter~     referred to as Vyndaqel) in all patients who received this drug under actual use conditions~     after its marketing.~   "
69599|NCT02146365|"~     One possible mechanism of protection from pneumococcal disease with a killed whole cell~     vaccine is by altering the carriage of pneumococcus germs in the nose and throat of those~     who get the vaccine. This study will look at nasal swabs from toddlers who received a killed~     whole cell pneumococcal vaccine (PATH-wSP) in VAC-010 and compare them to nasal swabs from~     toddlers of the same age who did not receive the PATH-wSP vaccine. This information will be~     used to help further develop the PATH-wSP vaccine. The research will be done in Kenya at one~     site in Kisumu (KEMRI). The study will enroll healthy Kenyan toddlers (12-15 months of age)~     who are participating in the VAC-010 study (N=250) and whose parents provide consent for~     this study. In addition 50 healthy Kenyan toddlers of similar age who did not participate in~     the VAC-010 study will also be enrolled.~      The toddlers will be followed for 6 months and will have 5 study visits. During those study~     visits each toddler will have their nose and back of their throat swabbed. The material from~     the swab will be analyzed for the presence and type of pneumococcal and other germs. At the~     last visit, one blood sample (5 ml or approximately 1 tsp) will be obtained.~      There will be no direct benefit to the participants other than direct and immediate medical~     care as needed.~      Parents of all participants will provide written informed consent.~   "
69600|NCT02146352|"~     The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent~     with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of~     pancreatic pseudocysts.~   "
69611|NCT02146209|"~     The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400~     mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl~     125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets~     (400 mg Metronidazole Per Film Coated Tablets).~   "
69612|NCT02146196|"~     Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in~     advanced heart failure and after cardiac surgery.~   "
69601|NCT02146339|"~     Polar lipids have a specific chemical structure: they are an essential component of human~     cell membranes, play a major role in the nervous system and also influence the metabolic~     pathways including the cholesterol metabolism.~      Polar lipids are used in food-processing industry for their emulsification properties. The~     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers~     such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have~     beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional~     origin.~      The purpose of this research is to study the variation of sphingomyelin content at the~     ileum's end after the consumption of different doses of milk polar lipids, and consequences~     on the intestinal absorption and metabolism of fatty acids and cholesterol.~      The subjects will be taking three different test meals varying by their milk polar lipids~     content.~      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine~     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).~   "
69602|NCT02146326|"~     Healthcare providers play an important role in helping patients be actively involved in~     treatment and recover from mental illness. But mental health clinicians, like other~     healthcare providers, are at risk for experiencing burnout—feeling emotionally drained from~     their work, having cynical thoughts toward patients and others, and feeling little~     accomplishment in their work. Burnout can lead to problems for the clinician including poor~     overall health, depression, and lower job satisfaction. Burnout also can impact how~     clinicians perform on the job; for example, people with high levels of burnout take more~     time off, show lower commitment to their job, and are more likely to quit or be fired. There~     is some evidence that burnout can affect the quality of care for patients, but very little~     rigorous research has tested this assumption. The purpose of our study is threefold. First,~     we will investigate how patients perceive burnout in clinicians and whether (and/or how)~     burnout impacts the care they receive. Next, we will test an intervention to reduce~     clinician burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and~     Education (BREATHE). BREATHE brings together tools that mental health clinicians are already~     familiar with, including relaxation and mindfulness exercises, setting boundaries, using~     social supports, and changing negative thought patterns and replacing them with more helpful~     ways of thinking. We have found this intervention effective in reducing burnout in other~     organizations, but have yet to study whether it also can improve patient outcomes.~     Clinicians (approximately 200) who participate will receive either the BREATHE intervention~     or training in motivational interviewing, which could also improve patient involvement in~     treatment and patient outcomes, but is unlikely to significantly reduce clinician burnout.~     We will also recruit 600 adult patients served by participating clinicians. We will survey~     clinicians and interview patients over a 12-month period after the intervention to determine~     how the intervention impacts clinician burnout and patient perceptions of care (relationship~     with the clinician, degree of autonomy in decision making), patient involvement in care, and~     outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally,~     this study will use a statistical procedure called Structural Equation Modeling to test a~     theoretical model of the relationship between burnout and patient outcomes. Findings from~     this study will show whether reducing clinician burnout can improve patient outcomes and the~     quality of care that patients receive. Our intervention will have the potential to be easily~     implemented in a variety of settings where burnout is a problem. Knowing how clinician~     burnout impacts patient outcomes, and whether improving burnout can improve patient care,~     can help improve the healthcare system.~   "
69603|NCT02146313|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DMUC4064A administered~     by intravenous (IV) infusion every three weeks (q3w) to cancer patients. The study will~     employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose~     (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended phase~     II dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian~     cancer and another in unresectable pancreatic cancer) may be evaluated to further~     characterize the safety and activity in these patient populations. Time on treatment is~     expected to last approximately 1 year.~   "
69604|NCT02146300|"~     The purpose of this study is to find out how the provocation of the nose changes breathing~     style (specifically, frequency and tidal volume changes)~   "
69605|NCT02146287|"~     Preterm babies cared for in the intensive care nursery are exposed to amounts of light that~     are very different from the exposures to an unborn baby or the newborn term baby. Currently~     many nurseries try to protect premature babies from too much light. They may also try to~     create light conditions of day and night like many parent homes. Some studies have shown~     improvements in health and development of babies cared for in nurseries that try to change~     light for premature babies.~   "
69606|NCT02146274|"~     PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness~     Research) is a three year research project to create a national, sustainable model to~     improve decision-making and patient-centered stroke outcomes through comparative~     effectiveness research.~   "
69607|NCT02146261|"~     This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind,~     placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and~     tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will~     be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per~     cohort, six subjects will receive the single subcutaneous E6011 administration and two~     subjects will receive the single subcutaneous placebo administration.~   "
69608|NCT02146248|"~     The investigators' research group is working to develop a highly effective, low cost~     non-surgical method of permanent contraception for women. To support this goal, we need to~     know more about the normal fallopian tube (tube that passes the egg from the ovary into the~     womb). The purpose of this study is to learn about how menstrual cycles and hormonal~     contraceptives affect tubal patency. Normally there is an opening between the tube and~     uterus to permit the flow of fluid and cells. If this opening is blocked, this can result in~     infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency~     is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy~     (HSG). HSG is a standard radiological imaging study that is used to determine if the~     fallopian tubes are open and free of disease. It is commonly done in women with an~     infertility diagnosis. The investigators usually do this test in the first 10 days of the~     menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are~     actually open. The timing of the HSG study during the menstrual cycle, or the use of~     hormonal contraception may make a difference in whether the tubes appear blocked on the HSG~     when they are actually patent.~      The results of the HSG test provide a good model for how our nonsurgical permanent~     contraception method might work. The investigators think that if the tubes are not patent,~     that our treatment will not work as well. Therefore, in this study we want to learn if~     menstrual cycle timing or current hormonal contraception use will affect the patency of the~     tubes as assessed by the HSG. The investigators want to examine the same women to see if~     tubal patency is changes during the menstrual cycle and during the use of a birth control~     pill and the birth control shot.~   "
69613|NCT02146183|"~     The aim of this experiment is to investigate if intake of stevioside in addition to a~     carbohydrate-containing composition after work related depletion of muscle glycogen will~     increase the rate of glycogen re-synthesis as compared with intake of the~     carbohydrate-containing composition alone.~   "
69614|NCT02146170|"~     Background:~      - Lung cancer is the leading cause of cancer-related death worldwide. It causes more than~     one million deaths every year. Researchers want to gather tissue samples from people with~     lung and thymic cancers to understand the disease better. This may lead to new ways to~     diagnose and treat it.~      Objective:~      - To collect tissue samples for use in the study of lung cancers.~      Eligibility:~      - Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra~     pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          They will be asked about how they perform their daily tasks.~        -  Participants may be asked to give urine and blood samples. They may give a saliva~          sample if they cannot give blood. They will also give a sample of their tumor from a~          biopsy they had. They may also be given the option to undergo a biopsy.~        -  Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine~          that takes pictures of the body.~        -  After visits to the Clinical Center end, researchers will contact participants by phone~          every year to check on their health.~   "
69615|NCT02146157|"~     This is a multi-center, randomized, double-blind, placebo-controlled study in approximately~     104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination~     product on fasting serum glucose levels in subjects with impaired fasting glucose. The study~     consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible~     subjects will be randomized to product to consume throughout the 12-week supplementation~     period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.~   "
69616|NCT02146144|"~     The epimacular membrane (EMM) is a degenerative condition associated with age, with a~     variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed~     by a peeling of the epimacular membrane using a microgripper. Peeling of the internal~     limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is~     expected to increase the success rate of EMM surgery by reducing the risk of recurrence of~     EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is~     not totally without consequence, it involves the risk of histological disorganization of the~     retina at the origin of one or several microscotomas, which are themselves responsible for a~     final visual discomfort. These microscotomas, resulting in the perception of somewhat black~     spots visible near the fixed point or the fixed image, may be highlighted by microperimetry~     and would be a loss of functional opportunity for the patient.~      In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not~     alter the vision in half the patients. Furthermore, for those patients who are functionally~     affected by any such recurrence, a second epimacular membrane peeling surgery can be done.~      The main objective of this study is to compare the difference in microscotoma(s) before~     surgery and 6 months later, between an active ILM peeling group and a no ILM peeling~     group. Given the more invasive nature of ILM peeling, the investigators believe that the~     rate of microscotomas in these patients is higher than those without peeling.~   "
69617|NCT02146131|"~     The purpose of this study is to compare the yield of two methods for obtaining a lung tissue~     sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure~     #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound~     (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look~     inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a~     technique that uses X-rays to see your lungs.~      This will give the doctor an opportunity to use either of the bronchoscopy methods described~     above and compare the tests to see if R-EBUS provides better results than standard~     bronchoscopy.~   "
69618|NCT02146118|"~     1. Title and stage of study A Phase II Study to Assess Efficacy of Combined Treatment with~          Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients with EGFR mutant lung~          adenocarcinoma~        2. Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free~          survival, overall survival, and safety assessment~        3. Study Rationale Even though it is commonly accepted that EGFR TKIs are effective to~          EGFR mutation positive lung cancer patients, still remains its resistance issue.~           The Silybin which is extract from mugwort bean Thistle and used for hepatoprotective~          drug for a long time with very low adverse events in Eastern countries. Recently, there~          are some reports regarding its anti-cancer effects through several preclinical studies.~           The safety of Siliphos which is developed agent from silybin for improving intestinal~          absorption was demonstrated in PhaseⅠtrial.~           Recently investigators found out Silybin is effective for blocking EGFR signal in~          different mechanism from Erlotinib and it can be expected additional impact with~          combination therapy with preclinical data.~           Our research team can expect to improve Lung cancer treatment if the combination~          therapy (Silybin_Erlotinib) improves patients' response and Overall survivor.~        4. Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4~          weeks~        5. Assessment criteria For toxicity assessment, posttreatment recurrence and survival~          rates will be investigated based on NCI-CTCAE ver 4.0 and RTOG. Efficacy assessment~          will be conducted through measurement of lesions by CT and RECIST criteria. Overall~          survival (OS), progression-free survival (PFS), and time to tumour progression (TTP)~          will be estimated using a Kaplan-Meier analysis. In addition, effect of pre-treatment~          T790M on response and PFS will be analyzed.~   "
69619|NCT02146105|"~     Keeping individuals with knee osteoarthritis physically active is critically important.~     Exercise is effective at reducing pain while improving physical function. However some~     exercises can overload the knee, and as a result, worsen knee pain and health of the knee~     joint. Yoga offers a foundation of static postures that improve muscle strength and joint~     flexibility. Using sophisticated technology that allows us to calculate the loads inside the~     knee, the investigators have selected yoga exercises that do not overload the knee joint.~     The investigators have designed a yoga exercise class that is ideal for people with knee~     osteoarthritis. The purpose of the study is to investigate whether these yoga exercises~     increase muscle strength and reduce knee pain in women with knee osteoarthritis. In~     addition, the investigators aim to show that these yoga exercises will also improve knee~     loads during activities, mobility and heart health. The investigators will ask 50 women with~     knee osteoarthritis to participate in a 12 week yoga exercise intervention, that requires~     attendance to 3 classes each week. The investigators will test strength of the leg muscles,~     pain, knee joint loads, mobility and cardiovascular health before and after the 12 week yoga~     exercise intervention.~   "
69715|NCT02144857|"~     Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators~     investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction~     and myocardial dysfunction are impaired in patients with psoriasis compared to normal~     controls ,coronary artery disease patients and untreated hypertension subjects. The~     investigators also examined the effect of treatment with biological vs no biological agents~     on vascular and LV function in psoriasis.~   "
69620|NCT02146092|"~     After any surgery, there is a chance of complications. After lung surgery to remove tumours,~     there is a particularly high chance of a person developing an infection or needing help~     breathing, called post operative pulmonary complications. Currently, the risk of these~     complications is reduced through the completion of light physical and deep breathing~     exercises and walking around as soon as possible after surgery. Another possible way of~     helping these patients is to use a small device called an Incentive Spirometer to encourage~     and measure deep breathing. This study wants to compare how often postoperative pulmonary~     complications happen after major lung surgery between a group completing the exercises alone~     and a group using the Incentive spirometer in addition to the exercises. It is hoped that~     the combined therapy will reduce the amount of time patient must stay in hospital, have~     fewer complication events and have fewer patients re-admitted back into the hospital after~     they go home, so that patients overall have better outcomes.~   "
69621|NCT02146079|"~     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics~     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the~     investigated drug on the body), and the safety and tolerability of semaglutide in healthy~     male Japanese and Caucasian subjects.~   "
69622|NCT02146066|"~     The study is an open-label expanded access study for patients for whom vaccine was~     manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process,~     but who subsequently failed to meet specific enrollment criteria. Patients will receive~     therapy per investigator discretion (standard of care) as well as active vaccine per the~     020221 protocol administration schedule. It is estimated that approximately 99 patients will~     enroll in this study.~   "
69623|NCT02146053|"~     Oral iron supplementation is often associated with rapid onset of gastrointestinal~     side-effects. The aim of this study was to develop and trial a short, simple questionnaire~     to capture these early side-effects and to determine which symptoms are more discriminating.~      The study was a double-blind placebo-controlled randomized parallel trial with one week~     treatment followed by one week wash-out. Subjects were randomized into two treatment groups~     (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron)~     or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects~     completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal~     symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e.~     nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).~   "
69624|NCT02146040|"~     The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment~     in relation to thromboembolic events (stroke, and transient ischemic attacks) and~     intracranial hemorrhage.~      Primary Outcome Measures:~      - Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to~     diagnosis and anticoagulation treatment of AF during the study period; comparison of~     complications between those with and without anticoagulation treatment according to~     CHADSVASc score.~      Secondary Outcome Measures:~        -  The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes~          within 30 days after anticoagulation pause and the prevalence of stroke and~          intracranila bleeding in relation to INR level < 2, 2-3 and >3.~        -  Trauma as a risk factor for intracranial bleeding: percentage and risk factors for~          intracranial bleeding with or without trauma. Type of preceding trauma and type of~          intracranial bleeding.~        -  The time relation between diagnosis of AF and type of intracranial complications:~          Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding~          complications after 1st diagnosis of AF in patients with and without anticoagulation~        -  The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED~          score and anticoagulation/antithrombotic treatment~        -  Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and~          intracerebral bleeding in patients with and without anticoagulation~        -  Factors related to underuse of anticoagulation treatment. Data on reasons for not~          starting or stopping aticoagulation in those with indication of oral anticoagulation~        -  Operations and procedure as risk factor for stroke: Frequency and type of operations~          performed < 30 days before stroke. Data on length of perioperative pause in~          anticoagulation and use of bridging therapy and timiing of stroke are collected.~        -  Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after~          cardioversion in relation to use of anticoagulation and CHADSVASc score~        -  The risk of stroke and intracranial bleeding in relation to type of AF (permanent,~          persistent, paroxysmal) and concomitant carotid disease~      Estimated Enrollment: 6000 patients.~   "
69625|NCT02146027|"~     In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral~     control after treatment with antiretroviral therapy will be enrolled to receive once a day~     Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune~     parameters will be monitored for 12 weeks in both arms.~      The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T~     cells immune parameters.~   "
69626|NCT02146014|"~     Tobacco addiction is treatable with behavioral and pharmacological means, but results are~     often less than optimal. Transcranial direct current stimulation is a new non-invasive~     technique that applies weak electrical currents through the skull and has been shown to~     alter the excitability of certain brain areas. It is currently being tried in disorders~     where there is abnormal brain excitability, such as epilepsy and depression. A few studies~     have also been able to diminish drug craving, suggesting that brain excitability might also~     be altered in drug addiction.~      This study aims at non-invasively changing the excitability of certain brain areas-a~     procedure called neuromodulation- in order to help smokers quit smoking more easily.~   "
69627|NCT02146001|"~     This study is a randomized trial that will compare the effects of two, 12-week activity~     interventions on patterns of physical activity, physical health, and quality of life~     measures in 40 older adults who are able to walk for exercise. One intervention will target~     150 minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with~     current recommendations. The other intervention will target a decrease in time spent in~     sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an~     activity armband which will allow them to self-monitor their activity or sedentary behavior~     in real time using a smartphone. The armband will also provide objective data to an~     interventionist that will facilitate the intervention. The main outcome will be time spent~     in moderate exercise.~   "
69628|NCT02145988|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled study of~     DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral~     arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin~     treatment will augment significantly the resting ABI in diabetes patient with PAD in~     comparison with that of aspirin alone.~   "
69649|NCT02145715|"~     Velcade (bortezomib), thalidomide and dexamethasone (VTD) has been demonstrated to be a~     highly effective combination in both patients with previously untreated and those with~     relapsed multiple myeloma. In previously untreated patients VTD demonstrated clear~     superiority to TD as induction therapy prior to planned tandem autologous stem cell~     transplant.~      The rationale of this trial is to combine a 'gold standard' antiMM combination with the HDAC~     inhibitor Panobinostat. There is emerging data to support the concept of clinical synergy~     between BTZ and HDACi's.~      The purpose of this study is to determine the maximum tolerated dose (MTD) and estimated~     response rates of panobinostat, administered in combination with VTD, in subjects with~     relapsed and relapsed/refractory multiple myeloma.~   "
69629|NCT02145975|"~     Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in~     severe acute postoperative pain acts faster than its congener (morphine ) for pain relief .~     In the literature there is no study that corroborates this theoretical assumption and~     proposes to compare which has fewer adverse effects. This drug produces effects similar to~     those reported for morphine but less magnitude and has the advantage that during the~     postoperative period respiratory depression, antitussive effect , gastrointestinal~     discomfort and physical dependence are manifested in a significantly less degree.~      Trying to solve the management of postoperative pain relief , our objective is to determine~     by controlled clinical trial of superiority if in adult patients undergoing surgery ,~     fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia~     care unit compared to morphine.~   "
69630|NCT02145962|"~     An open multicenter trial to document the efficacy and safety of two therapeutic Extremely~     Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot~     Ulcers.~   "
69631|NCT02145949|"~     As a function of the growing population of older adults, an estimated 3.48 million total~     knee arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite~     the near-universal success of this surgery in mitigating chronic knee pain, TKA is not~     successful in restoring long-term physical function in older adults, primarily because of~     quadriceps muscle atrophy, which explains 77% of the strength deficits. Overall, strength~     and functional mobility in TKA patients is 30-50% below age-matched healthy controls.~     Functional tasks such as stair-climbing remain a clinical problem for 75% of patients~     following TKA. Muscle atrophy occurs in both operative and non-operative legs, and is~     essentially permanent for older patients because of their impaired ability to increase~     muscle mass. The purpose of this clinical research is to determine the effects of essential~     amino acid (EAA) supplementation on muscle mass, strength, and functional mobility following~     TKA in older adults. Based on strong preliminary data, the investigators hypothesize that~     twice-daily ingestion of 20 g of EAA for 1 wk before through 6 wk after TKA will increase~     basal rates of muscle protein synthesis via inactivation of catabolic signaling, and~     up-regulation of anabolic and cyto-protective proteins. The investigators further~     hypothesize that short-term atrophy prevention and accelerated return of functional mobility~     will lead to longer-term structural and functional adaptations, and improved quality of life~     in older TKA patients vs. Placebo. Identifying the mechanisms up-regulated by EAA treatment~     that preserve muscle volume and mobility will have a major impact on rehabilitation science.~     This study will accomplish two specific aims: (1) determine if EAA elevates basal rates of~     muscle protein synthesis by up-regulating anabolic pathways and cyto-protective proteins,~     and inactivating catabolic pathways in the short term vs. Placebo and (2) determine if~     short-term prevention of atrophy, weakness, and functional mobility leads to positive~     changes in muscle cell structure and function, and improved quality of life in the longer~     term vs. Placebo. This work is significant because it advances knowledge of the molecular~     and cellular changes occurring during muscle atrophy (Placebo) and atrophy prevention (EAA)~     in a clinical setting using a treatment that is broadly applicable, is well tolerated, and~     can be implemented immediately.~   "
69632|NCT02145936|"~     The purpose of this study is to to determine the effect of habituation to diets with~     different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular~     Disease (CVD) risk indicators with an emphasis on inflammation.~   "
69633|NCT02145923|"~     Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent~     high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive~     bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion~     two hours prior to autologous peripheral blood cells infusion. This is a single arm study~     with no control. All patients receive cell therapy.~   "
69634|NCT02145910|"~     This phase I trial studies the best dose of vemurafenib when combined with whole brain~     radiation therapy (WBRT) or stereotactic radiosurgery (SRS) in patients with v-raf murine~     sarcoma viral oncogene homolog B (BRAF) mutation-positive melanoma and brain metastases.~     Radiation therapy is an effective treatment for patients with brain metastases. Patients~     with multiple metastases are typically treated with WBRT. For patients with a few~     metastases, SRS alone can be used. Vemurafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Combining radiation treatment with~     vemurafenib for melanoma patients with brain metastases may result in improved local control~     and prolonged survival.~   "
69635|NCT02145897|"~     Various preclinical animal studies have shown the potential of stem cells in~     re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the~     potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot~     clinical studies indicate that stem-cell transplantation is feasible and may have beneficial~     effects in CLI. Injury or inflammation is a prerequisite for the participation of~     circulating stem cells to home and differentiate on to this microenvironment. The increased~     vascular permeability and expression of adhesion proteins like integrin assist in stem cell~     homing. The migratory capacity of stem cells is dependent on natural growth factors such as~     vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell~     factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic~     muscular tissue and is responsible for the recruitment of the stem cells to assist in the~     repair mechanism and consequent improvement in limb function.~      In addition to the above regenerating potential of SVF, they have several advantages; they~     can be easily isolated without further culturing it. Most importantly SVF have shown to have~     significantly highest expression of pluripotent markers similar to that of human embryonic~     stem cells and yet they are non-tumorogenic and safe.~      MSCs are having angiogenic activity and hence may be excellent source to develop~     neo-vasculature and hence could be explored for their therapeutic potential for treating~     Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules~     involved with cell attachment to neighbouring cells and to the extra cellular matrix19~     Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in~     preclinical studies to be safe and effective.~      The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal~     stem cells is conducted with the broad objective of establishing safety and efficacy.~   "
69636|NCT02145884|"~     We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming~     solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol~     maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of~     appropriate infantile hemangiomas.~   "
69637|NCT02145871|"~     The purpose of this study is to help us learn what is the best amount of fluid to give to~     patients during bladder surgery in order to avoid delayed bowel function after surgery,~     which could prolong hospital stay.~   "
69650|NCT02145702|"~     The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in~     patients with end stage renal disease.~   "
69651|NCT02145689|"~     This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients~     with upper limb spasticity.~   "
69652|NCT02145676|"~     This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper~     limb spasticity.~   "
69653|NCT02145663|"~     The aim of this study is to establish diagnostic and predictive biomarkers for patients with~     suspected acute stroke, that are transported by EMS as candidates for thrombolytic~     treatment. The study focuses on the ultra acute phase, <4.5 hours from symptom onset,~     including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2~     peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3~     month using the modified Rankin Scale (mRS).~   "
69638|NCT02145858|"~     Postoperative bleeding is a common consequence after heart surgery which can significantly~     impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. When bleeding occurs, reliable~     postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest~     tubes is imperative to facilitate pulmonary reexpansion and mediastinal decompression as the~     patient recovers. When post operative blood evacuation is inadequate, retained blood~     complications can result (herein described as the Retained Blood Complications (RBC). RBC is~     the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed~     and may necessitate drainage in the acute or subacute setting. The need for treatment and~     interventions for these conditions represents an impediment to patient recovery and involves~     both resource and economic consumption for a heart program and the healthcare system at~     large. Clinically, Retained Blood Complications (RBC) can be recognized acutely or~     subacutely. When it presents acutely, it is usually fresh thrombus around the heart or lungs~     presenting as tamponade or hemothorax. When it presents subacutely, it results in bloody~     pleural or pericardial effusions [Light RW, Light RW, Light RW, Ikaheimo MJ]. These~     effusions are often driven by the breakdown of remaining thrombus. Once RBC occurs,~     subsequent procedures may be needed to remedy it. A recent review of the literature~     indicated that additional procedures for RBC are demonstrated in approximately 15% to 20% of~     patients after heart surgery. In a prospectively collected United States Nationwide~     Inpatient Sample (NIS) data from 2010, RBC could be demonstrated in 17% of patients. In this~     analysis, mortality was doubled from 4% to 8%, length of stay was increased by 5 days, and~     average costs were 55% higher. Patients with RBC, therefore, represent an increased at risk~     population for complications and costs.~      Postoperative obstruction of conventional chest tubes with blood and other fibrinous~     material in the setting of postoperative bleeding contributes to RBC.(Shalli) In a recent~     study of postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients~     were found to have evidence of chest tube obstruction [Karimov JH]. Active Clearance with~     PleuraFlow has been shown to prevent chest tube clogging, and reduce RBC. (Shiose, Arakawa,~     Perrault) The purpose of this registry is to evaluate the effectiveness of PleuraFlow~     System, a commercial Class II (US), Class IIb (Canada, Europe, and Australia), in the~     management of blood evacuation after cardiac surgery. Additionally, the purpose is to~     educate about the incidence of complications and post-surgical interventions consistent with~     Retained Blood Complications (RBC) after adult cardiac surgery. The purpose of this registry~     is also to collect post-market surveillance data on PleuraFlow ACT.~   "
69639|NCT02145845|"~     This study is intended to collect safety and effectiveness data on the Cook Injectable Small~     Intestinal Submucosa (SIS)~   "
69640|NCT02145832|"~     This study is designed to determine whether micafungin is as efficacious as the current~     standard of fluconazole, to compare the safety of the two drugs in the treatment of proven~     neonatal candidiasis.~      It is also designed to further elucidate the pharmacokinetics of the two products in the~     growing and developing neonate and premature infant.~   "
69641|NCT02145819|"~     The aim of the study is to determine whether spontaneous LH peak is superior to human~     chorionic gonadotropin before a transfer of a day 3 frozen embryo.~   "
69642|NCT02145806|"~     1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women~        2. Evaluation the effect of urinary incontinence in pregnant and postpartum women.~   "
69643|NCT02145793|"~     Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence~     shows medications are effective in reducing ADHD symptoms, many families experience ongoing~     parenting stress around parent-child interactions. Children often have ongoing impairments~     in functioning. ADHD is a common condition identified and managed by primary care~     pediatricians. However current care in the clinic is not optimal to address parents' and~     children's needs around ADHD chronic care. Time is the biggest barrier. Group visits are a~     viable option to improve pediatric ADHD care, but requires extensive study. The goal of this~     proposed study is to test the feasibility and effectiveness of the group visit model for~     ADHD management within pediatric primary care. This study will be a randomized feasibility~     study that will generate important pilot data, as well as result in an innovative,~     exportable pediatric ADHD group curriculum for primary care practice.~   "
69644|NCT02145780|"~     Obesity is a complex and multifactorial disease representing a major public health~     challenge. Indeed, overweight and obese people carry a major risk of developing insulin~     resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be~     used to counteract some of the mechanisms involved in the generation of insulin resistance.~     The model of overfeeding represents a very good study model of the metabolic complications~     of obesity, since it has been shown to induce a transient state of insulin resistance in the~     human.~      The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric~     needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on~     insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on~     post prandial partitioning of exogenous lipids after a test meal.~      During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola~     in addition to their usual diet and will be supplemented with 2g of grape polyphenols~     extract or with placebo.~   "
69645|NCT02145767|"~     Miscarriages and preterm births are common and serious events affecting women, families, and~     healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth~     is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key~     role during pregnancy, has been proposed as a possible medication to be used in pregnancy to~     prevent miscarriage and preterm birth among women who have bleeding in their first trimester~     of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical~     trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains~     uncertain and thus is not a recommended treatment in women with early pregnancy bleeding.~     The purpose of our study is to evaluate the effect of progesterone for the prevention of~     miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a~     clinical trial in which 850 women will be randomized to receive either progesterone~     supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of~     their pregnancy will be compared.~   "
69646|NCT02145754|"~     The main purpose of this study is to compare effectiveness of two different culture media~     for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from~     patients with erythema migrans.~   "
69647|NCT02145741|"~     This open-label dose escalation phase I trial, 1280.15, is with the first administration of~     BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale~     behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese~     patients with advanced solid tumours as weekly intravenous administration.~   "
69648|NCT02145728|"~     The purpose of this study is to evaluate whether individual cognitive functional therapy~     (CFT), when compared to group exercise classes is effective in reducing pain and disability~     in patients with non-specific chronic low back pain.~   "
69654|NCT02145650|"~     This study will examine the epidemiology (incidence and control of a disease), burden,~     clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral~     Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain~     Injury (TBI).~   "
69656|NCT02145624|"~     Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the~     Department of Health acted to protect newborns between birth and completion of primary~     immunisations, the period with greatest risk of disease.~      Vaccination of pregnant women with whooping cough vaccine in the third trimester of~     pregnancy was instigated nationally, so that antibodies produced by the Mum would cross the~     placenta to the unborn child, giving them passive protection at the most vulnerable time.~     This antibody transfer has been known for some time but has not been compared between the~     two whooping cough vaccines being used in pregnancy. Any effect the raised antibody might~     have on infant responses to the vaccines given in the first few months of life has also not~     been measured. This is particularly important as the infant immunisations include some of~     the same components as the whooping cough vaccines, which include diphtheria, tetanus and~     polio. Previous studies have shown that high levels of antibody prior to vaccination may~     affect subsequent antibody responses. It is therefore important to assess whether~     administration of the whooping cough vaccine in pregnancy adversely affects the protection~     afforded by the infant vaccines, particularly to those which are similar, namely tetanus and~     diphtheria as well as meningitis C and Hib vaccines which include diptheria and tetanus~     components in their structures. This study will assess immune responses of mothers and their~     babies (~200 pairs) to their vaccinations and will allow the comparison of two whooping~     cough vaccines being used in pregnancy. This will be done by taking small amounts of blood,~     which is the only way to measure antibody levels (the proxy of the immune response), before~     and after the vaccinations. A group of unvaccinated women and their babies (50 pairs) will~     also be recruited to allow comparison of their immune responses.~   "
69657|NCT02145611|"~     Cardiovascular disease is a major public health problem in our country. Among the causes of~     cardiovascular diseases are High Blood Pressure (HBP) and Diabetes Mellitus (DM). Type 2~     diabetes (DM2) is associated with a twofold risk of cardiovascular disease, and endothelial~     dysfunction is an early marker of vascular complications. There is evidence of action of~     glucagon-like peptide 1 (GLP-1) on endothelial cells and vascular smooth muscle.~     Vildagliptin is a drug used in the treatment of DM2 able to prolong the activity of GLP-1,~     improving glycemic control and endothelial function.~      Objectives: To evaluate the effect of vildagliptin on endothelial function in patients with~     DM2 and hypertension using the Endo-PAT 2000 device.~   "
69658|NCT02145598|"~     This is a multicenter, randomized, blinded, 2-arm phase IIb trial that will compare the~     efficacy and safety of Lenalidomide maintenance after Bortezomib/Melphalan/Prednison (VMP)~     induction to VMP without maintenance (Placebo). In addition the trial will assess the~     treatment of Revlimid/low dose Dexamethasone (Rd) as Salvage after VMP without sufficient~     response (less than PR) in an observational arm. Key eligibility criteria include patients~     with newly diagnosed multiple myeloma and who are 65 years of age or older or are not~     candidates for high-dose chemotherapy and autologous stem cell transplantation. Patients~     with poor performance status or serious coexistent medical conditions will be excluded from~     this study. After registration all patients receive 6 cycles VMP (modified according to~     Mateos et al.). Patients who receive at least a PR and completed VMP can be randomized to~     either Lenalidomide 10 mg/d continuously maintenance or to placebo. Randomization will be~     stratified according to the quality of response after VMP induction (PR vs. VGPR + stringent~     complete remission [sCR] + CR). Patients that are not able to complete VMP due to toxicity~     but reached at least a PR after a minimum of four cycles of therapy should immediately~     proceed to randomization. Blinded phase continues until progression or end of study. After~     unblinding, patients who received placebo should be treated with Rd.~      Patients that do not reach PR after induction with VMP or are progressive during treatment~     with VMP should not be randomized, but switched to the observation arm and treated with Rd~     immediately. The study treatment ends with the confirmed progression on maintenance~     treatment (Lenalidomide or placebo) for patients that reached PR with induction treatment,~     or with the confirmed progression on second-line therapy with Revlimid® and Dexamethasone~     for patients that did not reach PR on induction treatment. All patients will be followed up~     every 3 months after end of study treatment, until end of study. The study ends two years~     after Last Patient In (i.e. randomization for maintenance) if sufficient events for the~     primary endpoint were received, but not later than 8 years after trial initiation (whatever~     comes first).~   "
69659|NCT02145585|"~     Closed loop systems for anaesthesia have been shown to be more efficient than manual~     administration and than Target Control Infusion systems (TCI). So far, there is only one~     single-center study demonstrating that a system using simultaneously three closed loops for~     each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe~     and is more efficient than manual administration of anaesthetic drugs. Although the results~     of this study are very encouraging, they are limited by its sample of patients recruited for~     non-cardiac surgery only.~      The hypothesis of the present trial is that cardiac anesthesia using a completely automated~     anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia~     and muscle relaxation) is feasible, safe and reliable.~      Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on~     patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.~      Hypnosis is monitored during the surgery according to the brain activity values provided by~     an objective monitoring parameter, called Bispectral Index (BIS).~      A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be~     determined clinically by recording the % of sedation time during which the actual BIS is~     within 10% of the target BIS (excellent control), within 11 -20% (good control), between~     21-30% (fair control) and beyond 30% of target (inadequate control).~   "
69660|NCT02145572|"~     The purpose of this study is to identify unique metabolite signatures associated with the~     development of Type 2 diabetes and diabetic kidney disease in children.~      We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A)~     in the urine of adolescent females with polycystic ovarian syndrome.~   "
69661|NCT02145559|"~     Given the role of mTOR signaling and probable synergistic activity of combining sirolimus~     and metformin in patients with advanced solid tumors, the investigators hypothesize that:~        1. The combination of metformin plus sirolimus will result in reduction of p4EBP1, p70S6K~          and pAKT more than sirolimus alone in peripheral blood T cells (PBTC).~        2. The combination of metformin plus sirolimus will result in decreased levels of serum~          biomarkers including fasting insulin, C-peptide, glucose, triglycerides, LDH, IGF-1,~          IGF-1R, IGF-BP and leptin, but an increase in adiponectin in peripheral blood.~        3. Expression of active forms of AMPK, mTOR, PI3K, PTEN loss, AKT, LKB1, P62, LC3, and/or~          ULK1 in the tumor tissue (original pathology) will be predictive of response to~          combination therapy. This will be an exploratory hypothesis for this study.~        4. Sirolimus induced toxicity, especially hyperglycemia and hypertriglyceridemia, will be~          mitigated by combining sirolimus with metformin.~        5. Metformin plus sirolimus will have promising anti-cancer activity and this activity~          will correlate with decreases in the above biomarkers. This will be an exploratory~          hypothesis for this study.~   "
69662|NCT02145546|"~     The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would~     develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the~     accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose~     of the study is to assess the therapeutic effects of various antiarrhythmic drugs~     (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with~     AF, including the reduced AF burden (duration and episodes) and persistent AF free survival~     rate. All patients will be followed up for 12 months.~   "
70668|NCT02132364|"~     The main objective of the study is to compare the benefit of optimised follow-up by nursing~     personnel from the vascular neurology department, including therapeutic follow-up and an~     educational program directed to the patient and a caregiving member of his social circle,~     with that of a typical follow-up.~   "
69663|NCT02145533|"~     An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been~     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.~     Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP~     activity. The aim of this work was to study the relationship between the levels of MMPs and~     NGAL and arterial aneurysms.~      In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal~     disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with~     non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the~     control group (Group III).~      The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial~     aneurysm: 49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3~     common carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and~     2 females, age range 40-70 year-old, median 56) were enrolled in Group III.~      Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and~     NGAL in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in~     the aneurismal vessels.~      These results provide important advances in the understanding of the natural history of~     arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they~     may represent molecular markers for the prevention of aneurysmal rupture~   "
69664|NCT02145520|"~     In this study, investigators will compare the efficacy and safety of intravenous (IV)~     Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of~     hospitalization in admitted patients, as compared to placebo.~   "
69665|NCT02145507|"~     This study will evaluate a new blood collection and filtration system that is intended to be~     used to collect, filter, separate and store red blood cells and, separately, plasma. The new~     blood collection and filtration system will be compared to an already-approved and currently~     used system. Further, this study will evaluate new processing conditions relative to the~     individual components of the collection and filtration system. All study participants will~     donate two units of whole blood with individual units being donated at least 56 days apart.~     One unit of whole blood will be donated with the new system, and the other unit will be~     collected with the already-approved system. A subset of the donors (approximately 24 of the~     120 participants) will have a small quantity of their red blood cells injected back into~     their body 42-days after they were donated in order to evaluate how well the red blood cells~     survive. Blood and blood products from all donors will be analyzed the day of collection and~     after storage (plasma after at least 30 days of storage and red blood cells after exactly 42~     days of storage).~   "
69666|NCT02145494|"~     Giving a higher dose of radiation to the dominant tumour nodule within the prostate is~     hypothesized to improve tumour control. This trial will assess whether this technique,~     delivered in 5 treatments, can be delivered without increasing side effects.~   "
69667|NCT02145481|"~     The objective of the DeQCAD study is to measure the quality of the decision-making process~     for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are~     making treatment decisions. In particular, this study is seeking to answer: a) How informed~     are patients about their treatment choices, b) are patients participating in the~     decision-making process as much as they would like to, and c) do the treatment decisions~     made match patients' preferences?~   "
69668|NCT02145468|"~     Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with~     Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing~     understanding that the inflammatory response to ACS is integral to the subsequent evolution~     of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an~     enzyme which may play a central role in inflammation in the setting of heart attack.~     Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent~     plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and~     thus reduce infarct size and the risk of subsequent cardiac events. This study will test~     whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as~     death, heart attack, or near heart attack requiring urgent treatment ) when started~     immediately after ACS (specifically, heart attack). Patients who present with heart attack~     and qualify for the study will be randomly assigned to receive 3 months treatment with~     either losmapimod twice daily or placebo, which will be administered in addition to the~     usual standard of care therapies for heart attack. Following the in-hospital period,~     subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit~     at 24 weeks.~   "
69669|NCT02145455|"~     This study will compare two different surgical methods used in total knee replacement with~     the Unity Total Knee Replacement System. The study will evaluate these two methods based on~     patients' ability to perform various tasks prior to surgery and at 4 time points during the~     first 12 months after surgery.~   "
69670|NCT02145442|"~     -  Obesity is an important and growing public health worldwide~        -  Obesity is highly related to the development of metabolic syndrome, diabetes,~          cardiovascular diseases and cancer~        -  An extensive body of evidence from efficacy trials has shown that weight loss is~          achievable, however, a modest weight loss is achieved in a small proportion of patients~        -  Important adverse events have been reported with the use of antiobesity drugs.~        -  The use of natural products with potential effects inducing weight loss is an~          alternative strategy for treating patients with overweight and obesity. However,~          efficacy and safety should be evaluated in RCT.~        -  Obex combines different molecules with potential effects inducing weight loss and~          control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.~        -  Therefore, the administration of Obex in overweight and obese patients with impaired~          fasting glucose could be an excellent strategy to induce weight loss and ameliorate the~          metabolic disturbances related to obesity and overweight.~   "
69716|NCT02144844|"~     The hypotheses were as follows:~      H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive~     behavioral intervention (CBI) group will maintain low-moderate risk status and have~     significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the~     (TAU) control group (as measured by percent of participants with EPDS scores <9 at T2 and T3~     and mean score changes).~      H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a~     significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD~     in the TAU control group (as measured by percent of participants with EPDS scores <10 at T2~     and T3 and mean score changes).~   "
69671|NCT02145429|"~     This study is being conducted in GOA India. The study addresses specific issues of~     depression prevention in older adults living in low- and middle income countries (LMICs), by~     developing risk-reduction strategies through the use of lay health counselors. We will be~     training Lay Health Counselors (LHC's) to deliver simple behaviorally oriented~     interventions, designed to enhance the ability to relax, to improve active coping via better~     problem solving, and to increase protective factors such as good quality sleep. Lay Health~     Counselors are inhabitants of Goa.~      The aim of phase 1 is to create a depression and anxiety prevention intervention for use by~     lay health counselors. We will test the feasibility and acceptability of Problem Solving~     Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The~     products of phase 1 will be a prevention and counseling manual to standardize the~     implementation of the interventions for further testing in a randomized prevention trial~     (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population.~      In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing~     and retaining participants; implement the experimental intervention and enhanced usual care;~     identify real world, barriers and develop strategies for addressing them; and assess the~     fidelity of the interventions.~   "
69672|NCT02145416|"~     This is a single arm, single centre imaging study which will be offered to all consecutive,~     eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within~     Oxford University Hospitals.~      Investigations~        -  Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)~        -  Diffusion weighted magnetic resonance imaging (DWI MRI)~        -  MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)~        -  MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)~        -  Perfusion computed tomography (pCT)~        -  Fludeoxyglucose positron emission tomography (FDG PET/CT)~      Study Design: Observational~      Target Population: Patients undergoing radical CRT for anal cancer in Oxford University~     Hospitals National Health Service (NHS) Trust.~      Duration on study: Patients should be on study for a maximum of 5 months.~      Patient care post-trial: Follow up as per local standard.~      No. of Study Site(s): Single Centre, United Kingdon (UK)~      End of study: Last Patient, last assessment of response. Patients should be on study for a~     maximum of 5 months.~   "
69673|NCT02145403|"~     The investigators hypothesize that adding carfilzomib to standard conditioning regimen for~     allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant~     relapse and treatment-related mortality by decreasing severe GVHD, leading to overall~     improvement in transplant outcomes.~   "
69674|NCT02145390|"~     Bladder preservation in patients with complete response after neoadjuvant chemotherapy will~     lead to equivalent or superior relapse free rates compared to cystectomy rates from~     historical controls.~   "
69675|NCT02145377|"~     To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo~     to elicit a significant antibody response 14 days after vaccination, compared to baseline.~      To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two~     dose administration, to elicit antibody response by 14 days after vaccination.~   "
69676|NCT02145364|"~     This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20~     subjects will receive study treatments. Following study treatments, follow-up visits will~     occur at 60, 90 and 180 days from each subject's last study treatment.~   "
69677|NCT02145351|"~     Determine the impact of restoring normal heart rate response during exercise and daily~     activity in patients with heart failure and a preserved ejection fraction (HFpEF) and~     chronotropic incompetence (CI).~   "
69678|NCT02145338|"~     This research project is designed to find out whether people who suffer repeated urinary~     tract infections (UTI) related to the need to empty their bladders intermittently with a~     fine plastic tube (catheter); a process called clean intermittent self-catheterisation~     (CISC), benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis).~     The investigators estimate that about 40,000 people in the United Kingdom need to use CISC~     regularly to empty their bladder either because of nerve damage such as multiple sclerosis~     or because of failure of the bladder muscle to contract, and of these about 25% (10,000~     people) suffer frequent UTI. One way to reduce this problem may be to take a small daily~     dose of antibiotics and the study aims to find out whether such treatment is effective and~     worthwhile both for the people who suffer the problem and for the National Health Service~     (NHS).~      The two options to be compared in the trial are firstly, a once daily preventive dose~     (prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or~     trimethoprim or cefalexin), and secondly no prophylaxis. The investigators think that an~     overall decrease of 20% or more in the frequency of UTI would be large enough for future~     patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis~     routinely. The investigators will also assess any harm caused by continuous use of~     antibiotics, particularly side effects for those people taking them and changes in the~     resistance of bacteria to these antibiotics. The investigators can then work out whether the~     balance between the benefits and harms make the use of prophylaxis worthwhile to people~     carrying out CISC and for the NHS as a whole.~   "
69679|NCT02145325|"~     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have~     been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been~     shown to control immune responsiveness to alloantigens and significantly contribute to~     operational tolerance in transplantation models (15, 16). However, there have been limited~     efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for~     controlling graft rejection and inducing transplantation tolerance, such as for kidney~     transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the~     following cell properties could be necessary: ex vivo generation of sufficient numbers of~     cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in~     an alloantigen-specific manner, and survival/expansion after infusion for a critical, but~     currently unknown, period of time. Our published work and that of other investigators has~     demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to~     downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for~     prevention of allograft rejection in animal models (15,16). We have developed strategies for~     the ex vivo expansion of naturally occurring human Tregs (nTregs) that allow for the~     practical employment of this cellular therapy in the clinic. Our central hypothesis is that~     sufficient human nTreg can be expanded ex vivo and used to both prevent renal transplant~     rejection and facilitate the reduction and subsequent withdrawal of drug-based~     immunosuppression. This study will allow for us to define the safety of Treg adoptive~     cellular transfer (TRACT) in living donor renal transplant recipients that draws upon our~     extensive preclinical experience with expanded Tregs, as well as our recognized clinical~     expertise with designing immunosuppressive regimens compatible with this type of therapeutic~     cell transfer.~   "
84352|NCT01953289|"~     The purpose of this study is to evaluate the frequency of positive free fluid cultures in~     both perforated and non-perforated appendicitis. In addition predictors of positive free~     fluid cultures will be analyzed.~   "
69680|NCT02145312|"~     One promising approach to the treatment of cancer is inhibition or modulating the crucial~     signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in~     the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is~     an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell~     growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II~     study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic~     SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more~     clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR)~     at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based~     on RECIST version 1.1.~   "
69681|NCT02145299|"~     This is a prospective, multicenter, randomized, single-blind study enrolling up to 75~     subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO~     will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the~     CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per~     hospital protocol and antiplatelet therapy with aspirin and clopidogrel.~   "
69682|NCT02145286|"~     The purpose of this research study is to evaluate the safety and effectiveness of an~     experimental procedure called Focused Radiation that may result in a faster way to plan and~     deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous~     tumors that originally came from another organ and have spread to bones). In this trial a~     single fraction of radiation will be given from 8-15 Gray.~   "
69683|NCT02145273|"~     Maternal depression is a pervasive problem that disproportionately affects low-income~     mothers. The effects of depression on mothers and their parenting result in many negative~     outcomes for children, particularly in terms of school readiness. The proposed research will~     build on a successful partnership between the University of Southern California School of~     Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an~     evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start~     mothers with depression or dysphoric mood with the goal of reducing their depression and~     promoting positive changes for both mothers and children. The objectives of the study are:~     (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G~     via a randomized controlled trial in Head Start centers in Los Angeles County operated by~     CII; (3) evaluate the effects of the intervention on maternal depression, parenting~     behaviors, goal-directed behavior, interpersonal relationships, physical health, and child~     behavior and school readiness; and (4) develop a manual for use of the intervention in Head~     Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers~     each, randomized by Head Start site; one will receive the intervention and the other~     services as usual. Outcomes for both mothers and children will be tracked for 2 years after~     the intervention, allowing for the evaluation of short- and long-term effects. The~     intervention will be delivered by Head Start mental health workers under the supervision of~     Scott Stuart, a national trainer of the intervention. This intervention has the potential to~     be a low-cost, high-impact intervention that can be replicated to other Head Start sites~     across the country to improve the lives of Head Start children and families.~   "
69684|NCT02145260|"~     Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood~     pressure that cause symptoms and/or require an intervention. They are common, affecting up~     to one third of maintenance HD sessions. Detrimental associations include: development of~     myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater~     mortality.~      Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular~     and intra-cellular compartments, promoting trans-cellular fluid movement and resultant~     hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa),~     may ameliorate excess SBP decline during HD.~      This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L)~     dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on~     intra-dialytic blood pressure and biomarkers of cardiac ischemia.~      The investigators will randomly assign subjects to higher versus lower DNa during their~     hospital stay, up to a maximum of six HD sessions.~   "
69685|NCT02145247|"~     Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen~     is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow~     and mature, there are more androgen producing cells. Women with PCOS have more follicles~     than normal women and therefore more androgen producing cells. While androgen production has~     been associated with the number of follicles, the relationship to the individual size of~     follicles in PCOS or normal women. This study intends to determine whether the size and~     number of ovarian follicles are correlated to androgen production in PCOS and normal women.~   "
69686|NCT02145234|"~     The purpose of this study is to evaluate the safety, tolerability, immunogenicity,~     pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy~     adult subjects.~   "
69687|NCT02145221|"~     The investigators are studying music therapy as an incentive and adjunct to a comprehensive~     spine surgery rehabilitation-recuperation program. Through the use of music therapy~     psychosocial support is motivated by the clinical use of music. The program will investigate~     the use of music therapy as an option for managing symptoms associated with spine surgery~     recovery. The proposed program will investigate the use of music therapy as an integrative~     treatment within Beth Israel's Department of Spine Surgery.This study will investigate the~     effects of music therapy in managing spine surgery recuperation and to reduce the intensity~     and experience of pain. Outcomes will include: Pain (pain medication dosage and patient~     report) using a CAS Color Analysis Scale and the VAS Pain Rating Scale, level of~     self-reliance/independence using physical therapy assessment scale, cooperation through~     evaluating number of times patient declined/accepted services, length of stay, patient~     satisfaction/patient report, level of kinesiophobia using the Tampa Scale for Kinesiophobia~     and anxiety/depression using the HADS during the period post-spine surgery.(see attached~     scales in Appendix section)~   "
69688|NCT02145208|"~     The study will include an implantation of the TIND device and 4 follow up visits up to 12~     months after the implantation.~   "
69689|NCT02145195|"~     The main purpose of this study is to investigate whether and in which doses vitamin D intake~     is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children~     during wintertime.~   "
69690|NCT02145182|"~     The purpose of this study is to determine if Eculizumab is safe and could be used to prevent~     delayed graft function following kidney transplantation.~   "
69717|NCT02144831|"~     The primary goal of the research is to determine if 10 days of dual anti-platelet treatment~     is as effective as 30 days of similar treatment in the prevention of stroke, myocardial~     ischemia (MI) and death in patients with TIAs and minor stroke.~   "
74030|NCT02088359|"~     Infants are exposed to either continuous bright light continuous near darkness or~     unstructured combination of the two. The investigators primary objective is to determine the~     effectiveness cycled light and near darkness on growth in preterm infants.~   "
69691|NCT02145169|"~     To describe the safety and efficacy of nitrous oxide during ketamine administration for the~     prevention of emergence reaction during Emergency Department procedural sedation and~     analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in~     emergency departments for procedural sedation and analgesia because they have a rapid onset~     and short duration of action. Unfortunately, all of these agents may cause respiratory~     depression, particularly when combined with other sedative agents, administered in large~     doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during~     ketamine administration may be an ideal combination for the prevention of emergence reaction~     in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent~     cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety~     and pain surrounding procedural sedation is not limited to the procedure itself, but the~     elapsed time from the time the patient enters the ED to the time spent in preparation for~     the procedure can be significant and lead to increased anxiety, which may exacerbate~     emergence reactions in adults. Using nitrous oxide before ketamine administration may~     mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults~     sedated with ketamine, the investigators believe that inhaled nitrous oxide may be~     equivalent to midazolam, with a better cardio-respiratory profile.~   "
69692|NCT02145156|"~     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination~     among the Hispanic population. The clinical objectives/aims of this HPV educational~     intervention project are to determine:~        1. The number of participants in each arm who received any dose of the HPV vaccine during~          the study period,~        2. The number of participants in each arm who initiated the HPV vaccine series during the~          study period,~        3. The number of participants in each arm who initiated but did not complete the HPV~          vaccine series during the study period,~        4. The number of participants in each arm, among all eligible, who completed the HPV~          vaccine series during the study period,~        5. The number of participants in each arm who completed the HPV vaccine series during the~          study period, among those who initiated the series at study start, and~        6. The number of participants in each arm who completed the HPV vaccine series among those~          who initiated the series during the study period.~      The implementation of this educational intervention in clinic waiting rooms is intended to~     assist primary care providers in communicating HPV vaccine awareness and education to~     parents and patients in a culturally tailored format.~   "
69693|NCT02145143|"~     The purpose of this study is to find out what effects, good and/or bad, a drug called~     vemurafenib, either alone or combined with another treatment called radioactive iodine, has~     on the patient and thyroid cancer. It is not known if vemurafenib works against thyroid~     cancer. This study will test in a small number of patients if it can be used with~     radioactive iodine to treat thyroid cancers. This type of study is called a pilot study. If~     the results are positive, a larger study with more patients may be done to further test this~     treatment.~   "
69694|NCT02145130|"~     The purpose of this study is the evaluation of the safety of autologous tissue-engineered~     dermal substitutes denovoDerm (first arm) and dermo-epidermal skin substitutes~     denovoSkin (second arm) transplanted onto the wound bed in children and adults.~   "
69695|NCT02145117|"~     This project aims to develop and test structural and functional brain imaging biomarkers for~     improvement in chronic pain from a mind/body intervention perspective in a critical veteran~     population, namely veterans with post traumatic headache (PTH) associated with mild~     traumatic brain injury (TBI). The project also aims to examine feasibility in a sample of~     veterans with PTH of performing resting state and structural neuroimaging protocols, and of~     obtaining active participation and completion of MBSR training. Lastly, exploratory analysis~     of brain imaging data will be performed to determine if hypothesized candidate biomarkers~     are associated with positive outcomes from MBSR and determine estimated effect sizes for~     future studies in PTH population.~   "
69696|NCT02145104|"~     The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus~     valsartan and valsartan alone in patients with essential hypertension inadequately~     controlled on valsartan monotherapy~   "
69697|NCT02145091|"~     This is a double-blind placebo-controlled study investigating the acute and persisting~     effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes,~     and brain functioning.~   "
69698|NCT02145078|"~     This pilot clinical trial studies whether the levels of certain genes in the tissue and~     blood are related to how well patients with stage IV non-small cell lung cancer respond to~     chemotherapy. Genes may affect how sensitive or resistant tumors are to chemotherapy.~     Studying the levels of genes related to tumor response before and after chemotherapy may~     help doctors learn whether they can predict how well patients will respond to treatment.~   "
69699|NCT02145065|"~     The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of~     the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment~     of femoropopliteal artery disease.~   "
69700|NCT02145052|"~     The primary objective of this study is to identify the optimal method of fascial closure of~     a laparotomy incision in high risk patients for intra-abdominal complications. The~     investigators hypothesize that interrupted closure is associated with decreased complication~     rates when compared with running/continuous closure. Secondary objectives are to determine~     the rate of dehiscence in continuous and interrupted suture technique, and to determine the~     rate of wound infection, hernia formation, and mortality associated with suture technique.~   "
69701|NCT02145039|"~     This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant~     (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of~     fludarabine, cyclophosphamide and low dose total body irradiation (TBI), is designed for the~     treatment of patients with advanced and/or high risk diseases.~   "
69702|NCT02145026|"~     This is a phase IV, prospective, multi-center, open-label study to assess the effectiveness~     and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult~     participants associated with low/intermediate-1-risk MDS. After screening, eligible~     participants will be treated with epoetin beta as recommended in the approved label and~     international guidelines for the use of epoetin in MDS participants and the dosage will be~     adjusted on the basis of erythroid response.~   "
74031|NCT02088346|"~     The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation~     system in making decision on IV thrombolysis.~   "
69704|NCT02145000|"~     The study is a double-blinded, randomized, placebo-controlled, trial with two groups of~     infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three~     doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will~     be administered at 4 week intervals between doses. The first administration will occur at~     6-8 weeks of age.~      We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo~     against severe rotavirus gastroenteritis in healthy infants in Niger.~      Active surveillance for gastroenteritis episodes will be conducted throughout the trial.~     Surveillance for adverse events will be carried out among all children from the time of~     first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events,~     including intussusception and death, will be conducted on all participants until they each~     reach two years of age.~      To assess the effect of prenatal nutrition supplementation on infant immune response to the~     BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a~     1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a~     lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks~     of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and~     enter the main trial as part of the immunogenicity sub-cohort.~   "
69705|NCT02144987|"~     The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may~     improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or~     Atrophic Endometrium.~   "
69706|NCT02144974|"~     Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative~     intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical,~     or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several~     options for pelvic floor and vaginal reconstruction have been described. The transverse~     musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free~     flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.~      Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction~     with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had~     vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative~     procedure and the outcome of the operation in these patients.~   "
69707|NCT02144961|"~     The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine~     green angiography (IGA) on both flap design and rate of post-operative fat necrosis in~     patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric~     Artery Perforator (DIEP) flap.~   "
69708|NCT02144948|"~     This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to~     antidiabetic standard care in patients with diabetes mellitus type II~   "
69709|NCT02144935|"~     Patients and families are invited to participate in an online registry and data repository~     specifically for patients with transverse myelitis. Their options are to join the data~     repository only, or participate in a clinical sub study in conjunction with the database~     repository. The data generated in this study will come from surveys, interviews, review of~     medical records, and physical examinations.~      Data from this study will be utilized to guide future clinical trials for children with an~     acute case of Transverse Myelitis. Parents and children separately will fill out an online~     data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will~     have both the parent and child fill out at time of symptom onset, and three time points to~     follow, 3, 6, and 12 months post symptom onset.~      A small subset of patients filling out the data registry will be able to travel to 1 of 5~     treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia,~     Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins~     University in Baltimore, MD for a physical examination highlighting recovery from Transverse~     Myelitis.~   "
69710|NCT02144922|"~     Although statins reduce cardiac events in hypertensive patients with cardiovascular risk~     factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such~     patients. The investigators hypothesize that pitavastatin added to standard antihypertensive~     therapy will be superior to placebo in improving CFR in hypertensive patients with~     cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized~     comparison study using Doppler echocardiography.~   "
69711|NCT02144909|"~     The investigators are conducting a feasibility study using a randomized controlled trial~     (RCT) design in which participants will receive the Partners in Care (PIC) diabetes~     self-management intervention and then be randomized to either semi-structured social support~     or a standard follow-up control group. Participants in the support groups will receive a~     culturally-tailored, semi-structured social support program delivered in a community setting~     by trained community peer educators and other health professionals (e.g., pharmacist). The~     investigators believe that the addition of a semi-structured social support component as a~     supplement to an evidence-based diabetes self-management intervention will improve diabetes~     self-care maintenance.~   "
69712|NCT02144896|"~     Endothelial function of the skeletal muscle vasculature declines with advancing age.~     Although aerobic exercise training is commonly prescribed to combat loss of endothelial~     function in the elderly, the rate of compliance to training programs is low. Contrary to~     aerobic exercise training, stretching exercise is widely performed in elderly patients to~     increase muscle flexibility and to prevent muscle atrophy induced by immobilization.~     However, it remains unknown as to whether regular stretching of the calf muscles using ankle~     dorsiflexion splinting improves muscle blood flow. The purpose of the proposed work is to~     test the hypothesis that performance of ankle dorsiflexion splinting improves endothelial~     function and lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will~     be performed on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg~     vascular measures will be performed on the splinted and non-splinted legs prior to and at~     the end of the 4-week intervention.~   "
69713|NCT02144883|"~     This purpose of the study was to investigate the efficacy of telephone counseling to help~     pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone~     counseling increases the overall cessation rate during pregnancy, and 2) the counseling~     effects can be maintained postpartum.~   "
69714|NCT02144870|"~     The main purpose of this study is to evaluate the efficacy of a habit reversal based~     treatment programme compared to an alternative treatment which aims at the activation of~     resources in children and adolescents aged 8 to 18 years with tic disorders.~   "
69718|NCT02144818|"~     During the last decades, owing to the growing tendency of women to delay childbearing plans~     because of career and personal priorities, fertility specialists today are seeing more and~     more women with poor ovarian reserve and with poor ovarian response Controlled ovarian~     hyperstimulation (COH) is considered a important factor in the success of in vitro~     fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and,~     thereby, resulting in more than one embryo. However, owing to the extreme variability in~     ovarian response to COH, in a subgroup of patients with poor ovarian response, this method~     may yield a very small number of follicles After succeeding in maximal recruitment of the~     follicles, the triggering of ovulation is extremely important in order to achieve, as many~     as, mature oocytes.~      Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering~     compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH~     agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role~     of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH~     receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation~     and cumulus expansion .~      Another method described to trigger ovulation is the Dual triggering- GnRH agonist 40 h~     prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was~     described as the treatment in cases with recurrent empty follicles.~      The aim of the present study is to evaluate three different methods of ovulation triggering~     in women with poor ovarian response~   "
69719|NCT02144805|"~     The study compares short-term and long-term effects on myometrial thickness in women sutured~     by single- or double-layer technique by closure of cesarean uterine incision. The study is a~     randomized clinically controlled study.~   "
69720|NCT02144792|"~     The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the~     target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in~     neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker~     that can quantify the expression of P-gp because of the difficulty in measuring substances~     in the neurologic system and the lack of clinical trials. Here, the investigators use a~     novel non-invasive [11C] -verapamil Brain PET and SPAM analytic method as a surrogate marker~     for quantifying the expression of p-glycoprotein.~   "
69721|NCT02144779|"~     This project is evaluating the effect of a standardized communication intervention in the~     pediatric intensive care unit (PICU) on long-term distress of family members of children in~     the PICU for 5 days or longer. The study hypothesis is that intervention families will have~     lower (better) acute stress disorder scores when their child is discharged from the PICU and~     lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to~     the control group families. The investigators will recruit 220 families (110 in each of the~     control and intervention groups). Families who are randomized to the intervention group will~     receive routine visits from members of the PACT (palliative care) team at least three~     times/week to address psychosocial needs, keep families informed about their child's health~     status, and offer emotional and instrumental support and resources. Families in the control~     group will receive usual care in the PICU. The intervention will end whenever the child is~     discharged from the PICU, which usually happens within 3 weeks of enrollment. The~     investigators will assess family outcomes at discharge from the PICU and 90 days after study~     enrollment. The investigators will conduct two additional activities to learn more about the~     processes of care for those in both the intervention and control groups. First, during the~     intervention, the investigators will recruit 30 families (15 in each group) and ask~     permission to audio-record the family care conferences to assess communication styles and~     gain greater insight into the differences in practice with or without the participation of~     the intervention team. The investigators will obtain additional consent from participants in~     these family conferences who are not otherwise enrolled in the study. Second, after~     completion of the 3-month follow-up interview, a sub-sample of a different 30 families~     (again, 15 in each group) will be invited to participate in qualitative interviews to~     debrief about their experience in the study and the intervention (for those in that group).~     This will be a one-time interview scheduled within 60 days of recruitment for this part of~     the project.~   "
69722|NCT02144766|"~     The goal of the present study was to investigate the role of pro-inflammatory cytokines in~     myocardial dysfunction and injury resulting from noncardiac injury in children and whether~     or not anti-inflammatory treatment with caudal block prevents pro-inflammatory~     cytokines-associated myocardial dysfunction and injury following noncardiac surgery.~   "
69723|NCT02144753|"~     The objective of this Phase II trial is to test the NTX-1 Fiber in patients with~     constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially~     modify gut microbiota composition, and improve gut milieu in these patients. The~     investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e~     has less side effects) and is more effective than psyllium (the most commonly used fiber in~     the US) for symptom improvement and is effective in correcting the abnormal colonic milieu~     in those with dysbiosis and low SCFA levels.~   "
69724|NCT02144740|"~     Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein~     hydrolysate) on systolic and diastolic blood pressure and flow-mediated dilation in a~     crossover designed study in healthy adults with mild hypertension.~   "
69725|NCT02144727|"~     In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric~     cancer in advanced gastric cancer (stage IB/IIA/IIB ).~   "
69726|NCT02144714|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and~     immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy~     subjects.~   "
69727|NCT02144701|"~     This randomized pilot clinical trial studies Lactobacillus rhamnosus GG in reducing~     incidence of graft-versus-host disease in patients who have undergone donor stem cell~     transplant. Lactobacillus rhamnosus GG may be effective at preventing for graft-versus-host~     disease caused by a donor stem cell transplant.~   "
69728|NCT02144688|"~     The purpose of this study is to contribute evidence towards the potential to improve~     cognition in HIV+ individuals experiencing cognitive decline through personalized change in~     antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to~     identify confounding clinical conditions, study participants will undergo a lumbar puncture~     to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF)~     genotype and tropism; and (iii) measure concentration of antiretroviral agents. When~     indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition~     will be measured in all at study entry and 6 months later.~   "
69729|NCT02144675|"~     This randomized phase II trial studies how well choline magnesium trisalicylate with~     idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used~     in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. It is not yet know whether choline magnesium trisalicylate and~     combination chemotherapy is more effective than combination chemotherapy alone in treating~     patients with acute myeloid leukemia.~   "
69730|NCT02144662|"~     Primary Objective: To investigate the pretreatment quantitative factors as shown in SD-OCT~     images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis~     (Ranibizumab) for RVO.~      Secondary Objectives: Correlations between posttreatment BCVA and pretreatment factors were~     evaluated, including age, pretreatment BCVA, photoreceptor outer segment (PROS) length,~     central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer~     thickness (ONLT). The factors influencing posttreatment BCVA were evaluated using multiple~     regression analysis.~      Detailed information on macular morphology, such as the photoreceptor IS/OS junction and~     ELM, can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye~     disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹~     Other investigators suggested that the thickness, area, and volume of the outer layer were~     correlated with BCVA in patients with dry age-related macular degeneration (AMD).² Outer~     foveal thickness (OFT) and relative reflectivity of the outer nuclear layer (ONL) were~     associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to~     be associated with BCVA in patients with AMD.5 The aim of this study was to investigate the~     pretreatment quantitative factors as shown in SD-OCT images that correlate with~     posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.~   "
69731|NCT02144649|"~     This randomized pilot clinical trial compares tangerine and red tomato juice in treating~     patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found~     in tomatoes, may help prevent normal cells from transforming into cancer cells in patients~     with prostate cancer.~   "
69732|NCT02144636|"~     This randomized control trial of diet with protein supplementation is being conducted to~     test the hypothesis that in overweight/obese subjects high protein diet may lead to weight~     loss and improvement in cardio-metabolic profile.~   "
69733|NCT02144623|"~     This trial includes patients with chronic lymphocytic leukemia, the most common kind of~     malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation~     antigen 20 have improved treatment results in different forms of lymphomas; however in~     chronic lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it~     has been suggested that this is depending on a lower expression of the cluster of~     differentiation antigen 20 protein on the chronic lymphocytic leukemia cells.~      Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation~     antigen 20 expression, and the rationale in this study is that an increasement of cluster of~     differentiation antigen 20 would make treatment with monoclonal antibodies in patients with~     chronic lymphocytic leukemia more effective.~   "
69734|NCT02144610|"~     Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb~     Ischemia.~   "
69735|NCT02144597|"~     Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat~     content and size thereby improving surgical outcomes. This study aims to investigate whether~     a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat~     further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI).~     The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat~     further than the conventional food pre-operative diet.~   "
69736|NCT02144584|"~     This will be a randomized double blind placebo-controlled pilot study using a repeated~     measures design in which participants with acute ischemic stroke and upper extremity~     weakness are randomized to either drug or placebo~   "
69737|NCT02144571|"~     It is known that diet and physical affect a variety of disease-related endpoints and overall~     health status in general. The investigators also know that dietary and PA intervention~     effects are difficult for individuals to maintain. By contrast, the investigators have some~     evidence that group-based and family-centered, multi-component interventions are more~     effective in terms of creating large changes in diet-related outcomes. Using a~     group-randomized, controlled design, the overall goal of this project is to reduce breast~     cancer-related health disparities in a high-risk community, by achieving these Primary~     Aims,to conduct a regionally-based community-designed dietary and physical activity~     behavioral controlled trial among AA women,to test the effectiveness of the~     community-designed, family-based dietary and physical activity behavioral intervention on~     modifying biomarkers of inflammation and to test the effectiveness of the~     community-designed, family-based dietary and physical activity behavioral intervention on~     decreasing breast density~   "
69738|NCT02144558|"~     Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused~     among others by a deficiency of sperm quality particularly motility and vitality. Several~     mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and~     seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS).~     However, no French study of sperm quality has been conducted in this population that could~     identify aggravating factors of sperm quality and a way to prevent them.~      Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next~     stabilise. However, unidentified yet risk factors could influence long-term evolution of~     sperm parameters.~      The objective is to study the evolution of sperm parameters during 18 months taking into~     account bladder management, recurrent urinary tract and bladder infections, IS and OS. The~     evaluation of these parameters and their consequences will be indicative to determine one or~     more risk factors of sperm degradation and determine a strategy for long term support to~     avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors~   "
69745|NCT02144467|"~     Aim to establish a large-sample database of Multiple-MRI/Gene/Cognition for healthy~     Chinese (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary~     work for future researches such as development, aging, relation of gene and behavior,~     relation of gene and neuroimaging, relation of behavior and neuroimaging. Importantly, this~     work will provide a norm for researches on psychological or neurological patients. This~     large-sample will be shared with world-wide researchers.~   "
69771|NCT02144129|"~     The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated~     passive in a supine resting position or active during slight movements compared with a~     non-training control group on body composition, muscle strength and QoL in patients with~     ulcerative colitis.~      Our main hypothesis is that active WB-EMS application is significantly more favorable to~     address our primary endpoints compared with passive application.~      Our secondary hypothesis is that passive WB-EMS application is significantly more favorable~     to address our primary endpoints compared with non-training control.~   "
69739|NCT02144545|"~     Morbid Obesity (MO) is considered the most important epidemic in the developed world in the~     twenty-first century. After initial assessment of morbidly obese patients and the exclusion~     of potentially correctable causes, management involves a combination of dietary changes,~     cognitive therapy, physical activity, psychological support and pharmacological treatment.~     However, any combination of these factors has proven long-term effectiveness in achieving~     significant and sustained reduction of excess weight. Currently, surgery is the only~     treatment capable of achieving this goal, interacting also with significant improvement in~     quality of life and overall long-term mortality.~      In recent years, several authors have reported excellent short-term results with performing~     sleeve gastrectomy, but whether some aspects regarding the variability of gastric~     tubulization design could influence the results obtained in relation to weight loss and~     functional changes and gastric hormones.~      The main objective of this study is to assess the size of the gastric tubulization (based~     probe calibration and the distance from the pylorus to which initiate gastric section) that~     can provide a better clinical outcome (such as excess weight loss) in patients undergoing~     surgery for morbid obesity. Secondary objectives were to assess the morphological changes,~     physiological and hormonal obtained according to the size of the gastric tubulization and~     its effect on weight loss patients.~   "
69740|NCT02144532|"~     The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the~     connective tissue. This syndrome has different forms. Hypermobility type is the most common.~     It is characterized by generalized joint hypermobility, associated with a chronic pain~     syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived~     and the most crippling.~      Faced with insufficient effect of drug treatment, other alternatives have been proposed to~     relieve these patients. Compression garments have been developed. They appear as medical~     devices targeted specifically for patients with hypermobility EDS type: in the symptomatic~     treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle~     globulization, and in the functional improvement.~      The VETCOSED study is a quasi-experimental study of type Before / After, monocentric,~     open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues~     - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale~     Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with~     EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will~     wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks~     during which they do not carry this garment.~      The main objective is to demonstrate the effectiveness of compression garments in the EDS~     hypermobility type, especially in terms of symptomatic improvement joint pain.~      The main outcomes expected of this study are:~        -  an improvement of the power and the peaks of couple of muscles rotators of shoulders.~        -  a decrease of the pains and the defects of articular stability of the shoulder~        -  an improvement of the quality of life and the functional independence of these patients~   "
69741|NCT02144519|"~     The investigators long-term goal is to advance the adoption and successful implementation of~     policies that promote PA and nutrition in after school programs (ASP) nationwide. The~     investigators objective here is two fold. First, the investigators will test the~     effectiveness of two promising strategies designed to 1) increase the amount of PA children~     accumulate while attending an ASP and 2) promote changes in the nutritional quality of the~     snacks served. This represents a fundamental step in establishing practice-based guidelines~     (best practices) for the uptake and achievement of public health policy goals (CA and~     Harvard). Second, the investigators will examine the barriers and facilitators to~     implementing these strategies. The expected outcome of this study is evidence supporting~     best practices for ASPs to employ to meet policy goals.~   "
69742|NCT02144506|"~     The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding~     recruitement of eligible participants, adhesion rate, datarecording and cost. In this~     feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to~     one of two interventions. The control group gets a well-known home-based exercise program~     (OTAGO) aiming to prevent falls where the exercises are prescribed by a physical therapists.~     The exercises will be presented on a booklet and on printed cards. The Intervention group~     consists of an exercise program, the T&E program, where the elderly persons can choose the~     exercises depending on their abilities. The exercises in the T&E program will be presented~     in a printed manual and shown on videos on an electronic tablet. Both intervention groups~     receive 6 hours of instruction and control/supervision sessions by physical therapists. In~     addition, the participants will exercise alone.~      The interventions will be performed over 24 weeks.~      In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other~     feasibility criteria will be costs, data recording issues and the qualitative evaluation of~     the booklet and the tablet.~      Falls will be assessed with a falls calendar. The amount of physical activity of the~     participants is assessed with an accelerometers (actigraph) and quality of life will be~     assessed with OPQOL-35 at baseline, week 16 and week 24.~   "
69743|NCT02144493|"~     Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis.~     However, the exact pathophysiology or mechanism of recurrent cholangitis has not been~     established. Periampullary diverticulum and narrow angle of common bile duct have been~     postulated as risk factors of recurrent common bile duct stone. The aim of this study was to~     evaluate the association between periampullary dierticulum, angle of common bile duct and~     recurrent common bile duct stone.~   "
69744|NCT02144480|"~     Although the benefit of cardiac rehabilitation following coronary artery bypass graft (CABG)~     is well-established, it is underused. The current investigation will adopt an early,~     intensive, short-term and supervised aerobic training at moderate-intensity. The inclusion~     criteria are diagnosed coronary artery disease (CAD) and clinical indication for elective~     first-time CABG.~      Regular physical exercise is associated with overall reduced risk of primary cardiac arrest.~     Previous study demonstrated that moderate-intensity exercise training reduced resting and~     strenuous exercise-induced activation of platelet and possibly coagulation. Our main~     research question is that whether the short-term CR program in the present investigation~     will ameliorate hemostatic imbalance at rest and platelet coagulation activation at maximal~     stress exercise.~      This is designed to be a prospective randomized controlled study. Sixty men who are~     scheduled to receive elective CABG in Chang Gung Memorial Hospital at Linkuo will be~     enrolled in the study. They will be randomized into two groups: intensive training (IT) and~     usual rehabilitation (UR). Participants in the IT group will receive intensive aerobic~     training at moderate intensity after CABG. A submaximal exercise test will be performed for~     intensity prescription. They will receive two training sessions per day and at least 20~     sessions in total. The CR group will receive usual CR program. After intervention, each~     participant will receive a maximal exercise test. Additionally, six-minute walk test,~     generic and disease-specific quality of life, will be collected before and after training.~     Additional 20 age-matched non-sedentary and healthy men without training will be recruited~     as control group.~      Venous blood will be sampled three times (before and after rehabilitation and maximal stress~     test) for the assessment of platelet activation by flow cytometer and activity of~     coagulation factors. Mean platelet volume, and platelet activation markers (platelet-bound~     CD62P%G, CD63%G, CD40L%G) will be analyzed. Various coagulation and fibrinolysis factors~     will be quantified.~      We hypothesized that this training program will ameliorate the prothrombotic state and~     attenuate platelet reactivity and coagulation induced by strenuous exercise in patients~     after CABG. Hopefully, this clinical investigation will establish an early short-term~     rehabilitation model following CABG and its efficacy for clinical use.~   "
74329|NCT02084420|"~     The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation~     effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric~     and/or Duodenal ulcer patients with H.pylori positive infection.~   "
69746|NCT02144454|"~     Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women~     have a lower risk of CVD compared with men of a similar age. However, the incidence of CVD~     increases greatly after the menopause. The risk of heart disease is strongly associated with~     the health of an individual's blood vessels. It is thought that changes to the type of fat~     the investigators eat in their diet may affect the normal functioning and elasticity of the~     blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet~     include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found~     mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter~     and cheese). Since the investigators are in the fed (or postprandial) state for up to 18~     hours of the day, it is important to see how these different fats affect the investigators~     blood vessels and blood fats over the course of the day after eating a meal. The aim of this~     study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats~     or monounsaturated fats influence the normal functioning and elasticity of the blood vessels~     throughout the day in postmenopausal women. A secondary aim is to determine the effects of~     these different dietary fats on a range of accepted heart disease risk markers including~     circulating levels of fats (lipids) and glucose in the blood.~   "
69747|NCT02144441|"~     This study will examine the feasibility of implementing a clinician-supported patient~     self-managed inpatient insulin intervention. It will: assess the number of eligible patients~     presenting over time; assess patients' willingness to enroll; assess patients' ability to~     successfully complete the intervention; examine occurrences of hyperglycemia and~     hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.~   "
69748|NCT02144428|"~     The management of children with confirmed cow's milk allergy is based on complete avoidance~     of cow's milk proteins and leaves the physician with several dietary options, none of which,~     given the prevalence, spectrum and potential seriousness of the condition, can be~     recommended to all patients. In the absence of an alternative to cow's milk, the management~     of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate~     formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe~     for most children with cow's milk allergy, are still liable to contain residual peptides,~     and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus,~     specific product allergenicity must be addressed on an individual basis before recommending~     a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize~     cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety~     and nutritional efficacy perspectives. These formulas have been proposed for subjects highly~     sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed~     formula and for children with multiple food allergies. In these conditions aminoacid based~     formulas are able to effectively cure allergic symptoms and to improve body growth.~   "
69749|NCT02144415|"~     This single-center study will be a single-dose, randomized, double-blind, placebo- and~     active-controlled crossover study with a single inpatient treatment visit. The abuse~     potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of~     placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant~     users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient~     Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety~     Follow-up visit (Visit 4).~   "
69750|NCT02144402|"~     The primary objective is to determine if the weight gain of healthy term infants fed a~     commercially available term infant formula supplemented with DHASCO® is similar to that of~     infants fed the same formula supplemented with a new product, DHASCO®-B.~   "
69751|NCT02144389|"~     Randomized Controlled Trial:~      The investigational materials used in this trial were administered to subjects each day by~     trained clinicians.~      Primary Objectives:~        -  assess the effect of dietary supplementation with arachidonic acid on the cure rates~          for Schistosomiasis mansoni with and without concomitant treatment with praziquantel.~        -  assess the safety of dietary supplementation using arachidonic acid in children with~          clinically confirmed schistosomiasis mansoni infection.~      Secondary objective:~        -  to measure changes in total phospholipids in plasma.~   "
69752|NCT02144376|"~     The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure~     whole gut transit time in people with constipation, and how readily it can detect a change~     in transit time induced by taking a dietary supplement with laxative effects.The~     investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter~     through the intestinal tract.~      The investigators will also assess whether a change in gut bacteria and the chemicals that~     they release can be detected.~   "
69753|NCT02144363|"~     Mechanical ventilation used to support the sick newborn infant is associated with many~     complications including the development of chronic lung disease. Limiting prolonged invasive~     ventilation remains an important strategy to decrease lung injury and prevent chronic lung~     disease. Currently, there is no objective measure available to predict readiness for removal~     of the endotracheal tube (extubation) and discontinuing mechanical ventilation in this~     fragile population.~      The investigators propose to predict extubation success by evaluating the electrical~     activity of the diaphragm (Edi), which provides important information about the drive to~     breathing coming from the brain and the function of the diaphragm, two essential factors~     determining extubation readiness and success.~   "
69754|NCT02144350|"~     The investigators aim to prospectively study the feasibility and clinical impact of~     hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares~     as an adjunct to standard medical treatment. Specifically, we will investigate the impact of~     hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory~     markers. The investigators expect that hyperbaric oxygen therapy will improve patient~     responsiveness to steroids and avoid progression to second line therapy during~     hospitalization.~   "
69755|NCT02144337|"~     This study aims to test the feasibility of a physical activity intervention called the Steps~     To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus~     (T1DM).~   "
69796|NCT02143804|"~     This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and~     Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol~     (NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.~   "
69759|NCT02144285|"~     The purpose of this study is to look at the tolerability and safety of LY3113593. Study~     doctors will see how safe it is and whether it produces side effects following a single~     injection into a vein or under the skin in healthy participants (Part A) and participants~     with chronic kidney disease treated with hemodialysis (Part B). The study will also measure~     how much of the study drug gets into the blood stream, how long it takes the body to get rid~     of the study drug and what effects the study drug has on the body.~      This is the first time that this study drug is being given to participants. This study is~     for research purposes only and is not intended to treat any medical condition. For each~     participant, the study will last about 85 days, not including screening. Screening is~     required within 28 days prior to the start of the study.~   "
69760|NCT02144272|"~     The main purpose of this study is to learn more about the safety of LY3114062 and to find~     out how well it is tolerated in participants with an inflammatory arthritis. The study will~     also investigate how the body processes the drug and how the drug affects inflammatory~     arthritis. The study is expected to last about 3 months.~   "
69761|NCT02144259|"~     This is a prospective mixed methods study to assess weight changes in women randomized to~     receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who~     choose non-hormonal contraception or no contraception immediately postpartum. After~     enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a~     series of questions, take a pregnancy test, and be weighed. Total length of participation~     for each subject is 1 year or until pregnancy.~   "
69762|NCT02144246|"~     Primary Objective Our primary objective in this study is to evaluate satisfaction of~     hormonal contraception in this sample of women and to evaluate the impact that this hormonal~     contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles~     accompanied by cyclic exacerbations.~      We hypothesize:~      1a) women with CF who perceive an overall benefit of hormonal contraception will be more~     satisfied than women with CF who do not perceive a benefit,~      1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa~     mucoidy conversion while using hormonal contraception,~      1c) women with CF who have cyclic exacerbations will have improved patient-reported quality~     of life indices while on hormonal contraception, and~      1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function~     tests while on hormonal contraception.~      Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at~     the time of ovulation and compare it to that of healthy controls.~      We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.~   "
69763|NCT02144233|"~     The primary endpoint will be the average change in pain score from baseline to the three-~     and six-month assessments. Efficacy will be demonstrated by superior pain relief with the~     active treatment compared with the placebo.~   "
69764|NCT02144220|"~     The primary objective of this study is to evaluate the feasibility, efficacy and the value~     of providing care to individuals with Parkinson disease directly into their homes. The~     specific aims are:~        1. To demonstrate the feasibility of conducting remote evaluations of patients with~          Parkinson disease nationally;~        2. To measure the impact of remote care on each patient's ability to improve his or her~          quality of life (QoL) and better manage his or her Parkinson disease; and~        3. To assess the long-term acceptability to patients in receiving ongoing care remotely~          via telemedicine.~   "
69765|NCT02144207|"~     Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When~     under general anesthesia, these patients' airways must be managed to ensure continuous flow~     of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Most~     often for airway management under general anesthesia, a plastic breathing tube is placed~     though the voicebox (larynx) into the windpipe (trachea), a process known as tracheal~     intubation. To safely intubate, the larynx must first be exposed. In many cases, this is~     achieved by using a device known as a direct laryngoscope, which is like a curved, lighted~     tongue depressor. It is used to gently move the tongue out of the way, to expose the larynx.~     When the larynx is easily seen, passing the breathing tube is usually also easy.~     Unfortunately, in 2-5% of cases, it is difficult or impossible to view the larynx using the~     direct laryngoscope. This then creates difficulty with tube passage. A number of options~     exist to deal with this situation, including, within the last 10 years, a class of device~     called video laryngoscopes. These devices use a small video chip located towards the end~     of the blade, which, by providing transmission of an image of the larynx 'around the corner'~     to a screen outside the patient, enable a view to be obtained (when no such view could be~     obtained with direct laryngoscope). With the larynx now indirectly visualized, tube passage~     can proceed. However, it's not that easy. When using these 'around the corner'~     videolaryngoscopes, tube passage can be more difficult, as the tube must be guided around a~     90 degree bend from the mouth to the trachea, which sits at right angles to the mouth. Less~     difficulty occurs with tube passage when the direct laryngoscope is used because the blade~     compresses the tongue out of the way, creating a straight line from teeth to the larynx and~     windpipe beyond.~      The GlideScope is one example of video laryngoscope, and has been in use here at CDHA for 10~     years. It has been extensively studied over the ten years, with more than 300 studies~     appearing in the literature. The investigators know from these studies that it is very~     effective at delivering a view of the larynx when direct laryngoscopy has failed to do so.~     However, getting the tube to and through the larynx into the trachea, even with a good view,~     can be problematic. Furthermore, it is the impression of some clinicians that when a~     close-up, full view of the larynx is obtained (as is optimal for direct laryngoscopy) with~     the GlideScope, tube passage appears to be a little more difficult than seems to be the case~     when only a partial view of the larynx is obtained, from a little further away. The~     investigators don't know why this may be so, but may relate to one or more of a number of~     reasons, including (when too close) angling the larynx into an unfavorable angle, or (when~     further away) more favorably reducing the angle between mouth and larynx and trachea.~     However, no guidance on this question appears in the peer-reviewed medical literature, and~     no studies have been done. There is some suggestion in non peer-reviewed internet sites on~     airway management that a partial view may be better, but again, this has not been~     scientifically studied or validated one way or another.~      As mentioned, the GlideScope has been in regular use in CDHA for many years. Most often, it~     is used when difficulty with tracheal intubation is anticipated or has already been~     encountered in the anesthetized patient, although some airway experts suggest that within~     the near future, all intubations will occur with some sort of video laryngoscope.~      It is important to research the present question as in contemporary practice many~     anesthesiologists, faced with a patient in whom they are anticipating difficult direct~     laryngoscopy proceed with putting the patient to sleep, relying on the video laryngoscope to~     enable them to intubate. With a patient now anesthetized and not breathing, if they then~     have trouble intubating the patient in spite of getting a view of the larynx, harm could~     occur to the patient from a failed intubation situation. Furthermore, there are now a number~     of studies documenting that patient morbidity can increase with multiple intubation~     attempts.~   "
69766|NCT02144194|"~     This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel~     combination given as an initial upfront treatment (first line) to all metastatic breast~     cancer patients enrolled. Patients having a disease control following initial treatment,~     will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial~     will also compare the efficacy and safety of maintenance oral Vinorelbine versus~     Observation.~   "
69767|NCT02144181|"~     This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to~     88 subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22~     subjects), and will receive study treatments based on their assigned treatment group.~     Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each~     subject's last study treatment.~   "
69768|NCT02144168|"~     Primary objective of this study is to measure the change of concentration of faecal~     bifidobacteria between critically ill patients who receive enteral formula with and without~     prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in~     the concentration of faecal bifidobacteria between critically ill patients who receive~     enteral formula with and without prebiotics during enteral nutrition (EN). Three faecal~     samples will be taken from the patient. First faecal sample is the first stool after~     initiation of EN and second sample is taken seven days after the initial sample and the~     third faecal sample is taken at day 14 after initial sample. Patient will be randomized to~     receive either of described formula after baseline (first) stool sample is obtained. Patient~     will be monitored up to 14 days after the initial stool sample is obtained.~   "
69769|NCT02144155|"~     The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin~     in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute~     being on adequate treatment with antipsychotic medication.~   "
69770|NCT02144142|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective Staphylococcal species such as Staphylococcus~     epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a~     role in protecting the skin from invading pathogens. In this study, the study team will~     attempt to decrease S. aureus colonization and increase colonization by protective Staph~     species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The~     study team will selectively grow the subject's protective Staph colonies and place them into~     a moisturizer. The first part of the study will determine the half-life of the~     bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a~     subject's arm, and the subject will return at four different time points over the next three~     days for skin swabs of the arm that will be used to determine the amount and type of~     bacteria on the arm at those time points. In the second part of the study, the subject will~     apply moisturizer containing his own antimicrobial bacteria to one of his arms for a total~     of 6 times at a frequency determined by the half-life, which will be computed at the end of~     the first part of this experiment. The subject will return prior to the 7th application time~     point for skin swabs of the arm to ensure that there are still viable bacteria from the~     moisturizer present on the arm. In the third part of the study, each subject will receive~     both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject~     will apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm~     daily for a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs~     and clinical evaluations. If the moisturizer containing bacteria is able to decrease the S.~     aureus colonization on subject's arms, the study team hypothesizes that subjects will have~     improvement of their AD symptoms.~   "
69772|NCT02144116|"~     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with~     generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms~     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological~     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the~     general global population. Fibromyalgia is associated with balance problems and increased~     fall frequency. The objective of this study was to examine the effects of an 8 weeks~     dance-movement therapy programme on balance, strength, flexibility and quality of life in~     patients with fibromyalgia.~   "
69773|NCT02144103|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time into subtenon space of patient's eyeball.~     This is a single arm study with no control. All patients receive cell therapy.~   "
69774|NCT02144090|"~     The purpose of this study is to assess the usability and safety of the Opsens OptoWire and~     Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery~     disease who are undergoing a coronary angiogram.~   "
69775|NCT02144077|"~     The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used~     with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.~   "
69776|NCT02144064|"~     Objective To determine maternal and fetal outcomes in women with APS managed with aspirin or~     unfractionated heparin (UFH) plus aspirin during pregnancy.~      Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha~     university hospital. Methods: Pregnant women with recurrent miscarriage attending high-risk~     pregnancy unit. 140 selected patients with previous recurrent miscarriage are divided into 2~     groups: group A (n = 70) receive low-dose aspirin (81 mg once daily orally) plus heparin~     (5000 IU) every 12 h with the ﬁrst positive pregnancy test while group B (n = 70) receive no~     thing .~      Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic~     complications and pregnancy-induced hypertension .Prematurity, intrauterine growth~     restriction and neonatal death were considered as maternal and fetal complications~   "
69777|NCT02144051|"~     This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose,~     Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a~     multicentre study with sites in the United States and United Kingdom. Approximately 90~     patients are expected to be enrolled in this study.~      The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.~   "
69778|NCT02144038|"~     This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate~     the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when~     administered orally to adult patients with relapsed and refractory multiple myeloma. Once~     the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional~     patients will be enrolled in the Phase II part to determine whether the combination of~     LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent~     LGH447.~   "
69779|NCT02144025|"~     Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic~     bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment~     is initiated the damage to the lacrimal glands has already taken place.~      The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic~     transplants by using topical cyclosporine immediately after the engraftment has been~     achieved~   "
69780|NCT02144012|"~     This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical~     trial to investigate a first-line treatment of patients with HER2-positive metastatic breast~     cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced~     breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite~     primary multimodality therapy, and/or metastatic BC if they have not received prior~     chemotherapy for their metastatic disease. Eligible patients at up to approximately 40 sites~     in the Asia-Pacific region will be randomized in a 2:1 ratio to receive trastuzumab~     emtansine (Arm A) and will receive trastuzumab plus docetaxel (Arm B). All study drugs will~     be administered at in-clinic visits occurring every three weeks during the treatment phase.~     Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it~     represents a common first-line treatment option used in this patient population in China and~     other Asia-Pacific countries.~   "
69781|NCT02143999|"~     This observational study will evaluate the effectiveness of BRAF inhibitors and current~     therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600~     mutation. Patients will be treated per the locally approved therapeutic options in clinical~     practice. The observation period for each patient will be up to 24 months.~   "
69782|NCT02143986|"~     In healthy subjects, from 50 to 80 % of the serum ferritin is glycosylated [1, 2] . A~     decrease in the percentage of ferritin glycosylation can be observed in inflammatory~     diseases, malignancies, infections, or liver disease but is rarely less than 20% [3 , 4] .~     Percentage of glycosylated ferritin below 20% have been described in patients with adult~     Still's disease and haemophagocytosis lymphohistiocytic syndromes (HLH).~      The glycosylated ferritin has been included in the diagnostic criteria for Still's disease~     in adults. A cut-off of less than 20 % has a sensitivity and specificity of 72 and 69 %~     respectively , and 35 and 94 % when combined with a total ferritin level greater than 5~     times normal value. This parameter was also suggested to be a more specific marker to~     confirm a diagnosis of HLH than a high ferritin level ( > 500μg / L). However, several~     limitations of this parameter were highlighted, some conditions making its interpretation~     difficult : particularly in cases of major hepatic cytolysis and severe sepsis (miliary~     tuberculosis, lymphoma and disease Adult Still).~      It is not always possible to distinguish severe sepsis, HLH syndrome and Still's disease.~      A fine analysis of various glycoforms components of ferritin could be used to distinguish~     different subgroups of patients. Few data are available on the mechanism of secretion and~     glycosylation of ferritin, but the investigators assume that the glycosylation patterns of~     ferritin may vary between different disease states and reflect distinct underlying~     pathophysiological mechanisms.~   "
69783|NCT02143973|"~     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER~     tablets during a treatment period of up to 24 weeks.~   "
69784|NCT02143960|"~     The purpose of this study is to compare the clinical performance of the VelaShape III device~     with CoolSculpt for reduction of the waist, love handles and flanks.~   "
69785|NCT02143947|"~     The purpose of this study was to determine the effectiveness of two types of in-shoe custom~     made orthotics in altering the motion of the foot and muscle activity of select muscles of~     the lower leg in individuals experiencing lower extremity symptoms of a non traumatic~     origin. We hypothesized that orthotics would decrease the extent of motion of the during~     walking and running when compared to a barefoot condition. The investigators further~     hypothesized that orthotics would decrease the amount of muscle activity seen during walking~     and running when compared to barefoot walking.~   "
69786|NCT02143934|"~     This study specifically seeks to quantify the contribution of relapes to the burden of P.~     vivax infections and disease by determining on the effect of radical pre-erythrocytic and~     erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in~     children aged 5-10 years in a treatment to re-infection study design. In order the clear~     liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3~     days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days,~     0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.~      In addition to this epidemiological data, the study will assess the natural acquisition of~     cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the~     determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG~     children aged 5-10 years.~      These data will not only be essential for development of future vaccines against P. vivax~     and P falciparum but provide invaluable insight into the contribution of long-lasting~     liver-stages to the force of infection with P. vivax that will contribute towards designing~     more rational approaches to the treatment of P. vivax both in the context of case management~     and future attempts at elimination.~   "
69787|NCT02143921|"~     Alternative, sustainable interventions in support of zinc treatment for childhood diarrhea~     need to be identified. Within the NGO sector, direct provision of health services is~     provided, however some NGOs also work closely with the private sector providers.~     Hypothetically, this avoids unnecessary duplication of effort and enhances the quality of~     the care provided in the private sector. This study will provide objective evidence of the~     impact of this approach, using the scale-up of zinc for the treatment of childhood diarrhoea~     as a test case. The study will be assessing NGO impact among unregulated (unlicensed), rural~     service providers. Further, this study will serve to assess the value of this model of~     scaling up activities in the non-state sector with a particular eye toward more~     generalizable and replicable improvement in quality of care strategies between NGOs and~     unlicensed private providers. This will be controlled before-after (CBA) study. An~     equivalent control area will be included in the study. The objective is to document changes~     in zinc and antibiotic as well as anti-diarrhoeal usage in childhood diarrhea following a~     scale-up intervention package delivered by a local NGO to local private providers. This will~     include sensitization, training and follow-up support. Impact will be assessed in terms of~     changes in zinc coverage and antibiotic use among households in the catchment population~     served by these providers. The study will be conducted in four unions located in Sreepur~     Upazila within Gazipur district, located north to Dhaka. Two of the unions, namely Rajabari~     and Prohladpur comprising 55 villages with 15,530 households and an estimated 76,150~     population will serve as intervention area. The other two unions Telihat and Barmi will be~     taken as control sites. They contain 53 villages with 19,898 households and an estimated~     99,000 population. The curative health services in these sites are provided by local drug~     vendors, village practitioners, traditional healers, and licensed government, private or NGO~     health service providers. Data will be collected through survey and in-depth interviews.~     Data will be entered and analyzed using SPSS version 12.0. Absolute counts, proportions, and~     means with 95% confidence interval will be calculated. These and regression analysis will be~     done using STATA version 9, cluster survey program, that accounts for potential within~     cluster homogeneity. Based upon the household surveys, the outcomes that will be calculated~     are: coverage-the proportion receiving zinc, ORS (zinc and ORS), and antibiotics or~     antidiarrhoeals and changes in coverage 6 months following the introduction of the~     intervention package, equity: who is receiving zinc by age, gender and socioeconomic status.~     For differences in categorical outcomes crude relative risks and 95% confidence intervals~     will be determined. It is expected that the study will help in increasing zinc coverage for~     the treatment of children under five years of age and decrease in the use of antibiotics and~     antidiarrhoeals within the NGO catchment population.~   "
69788|NCT02143908|"~     Diarrhea as of today is still a major problem in developing world with high morbidity.~     Though mortality in under-5 children has declined over the years, diarrhea was responsible~     for 2.5 million deaths per year in developing countries. A median of 3.2 episodes of~     diarrhea in under-5 children per child-year has been estimated in developing countries. In~     Bangladesh, the overall prevalence of diarrhea was estimated to be about 2% for the entire~     population. However, a recent survey in 2003 with urban slum mothers indicated that the~     prevalence of diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum~     areas. Malnutrition remains the major adverse prognostic indicator for diarrhea related~     morbidity, which emphasizes importance of nutrition in early management. Repeated episodes~     of diarrhea are a frequent cause and consequence of malnutrition. To improve diarrhea~     situation in Bangladesh and elsewhere, interventions are directed to reduce mortality and~     morbidity through improvement of breast-feeding practices, complementary feeding,~     sanitation, increase in measles immunization rates, micronutrient supplementation, and oral~     rehydration therapy.~      L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme~     production. It is a protein-building block that strengthens and nourishes the structural,~     circulatory and immune systems. It is not produced by the body like other essential amino~     acids and must be obtained from the diet. Some natural food sources for L-lysine include~     Lima beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of~     lysine in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake.~     Studies have shown that lysine therapy improves immune status and is used as a therapeutic~     agent in herpes simplex viral infection. A double-blind randomized trial of L-lysine~     treatment found it to be an effective agent for significant reduction in occurrence,~     severity and healing time for recurrent herpes simplex viral infection. Lysine fortification~     increased the blood levels of complement 3 (C3), CD-4 and CD-8 T-cells as compared with~     controls. These two studies suggest that supplementation of lysine through food~     fortification enhances immunological status. A few recent studies have also shown an effect~     of lysine on diarrheal incidence and severity. An experimental model suggested inhibitory~     effect of L-lysine on incidence of diarrhea induced by stress and 5-hydroxytryptamine. A~     community trial among adults in Syria showed that the period prevalence and mean duration of~     diarrheal illness were significantly lower in the female participants who consumed~     lysine-fortified wheat bread compared to the control group as well as better immunological~     parameters such as C3c delta.~      The proposed study will observe the impact of a daily dose of 2000 mg supplemental L-lysine~     for 6 months on diarrheal illness in an adult population of an urban slum area in Dhaka~     whose principal diet is based on cereals such as rice and or wheat. The daily protein and~     lysine availability from diets of Bangladeshi population has been calculated to be about 43g~     and 1883 mg respectively, compared to 113g and 7,598 mg respectively in the USA. This means~     that 2000 mg daily supplementation of L-lysine would not pose any detrimental effect, as the~     combined usual and supplemental intake will still be substantially lower compared to the~     intake in USA. However, as expected, the supplemental L-lysine may reduce the incidence and~     severity of diarrheal illness through improvement of the nutritional and immunological~     status of the study population.~      The investigators propose to conduct a community-based, double-blind randomized controlled~     trial in Mirpur area of Dhaka city. Adults aged 18 to 45 years residing in the catchment~     area for at least the last six months will be eligible for the study. A total of 440~     subjects (220 females) will be enrolled. The results of the proposed study will contribute~     to our existing knowledge of the effect of lysine on incidence and severity of diarrheal~     illness as well as on immune status. A positive impact of lysine supplementation on~     diarrheal illness may lead to a future strategic approach to the control of diarrhea as a~     global public health problem.~   "
69789|NCT02143895|"~     Evaluation of the effects of etifoxine versus a benzodiazepine (lorazepam) on vigilance and~     cognitive functions in the elderly.~   "
69790|NCT02143882|"~     The Department of Health has recently announced the implementation of annual vaccination for~     all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is~     delivered as a nasal spray. This study seeks primarily to measure antibody responses to the~     LAIV vaccination over three subsequent years and will involve six blood samples, six dried~     blood spots (taken from the end of the blood sample needle) and six oral fluid samples -~     before and three weeks after each vaccination each year. These samples will allow us to~     assess how the immune system responds to the vaccinations in terms of the antibodies that~     are present.~   "
69791|NCT02143869|"~     Denutrition and Obesity are risk factors for perioperative surgical complications.~      In patient with cancer, incidence of denutrition is markedly increased. Surgical resection~     of cancer induces a high intensity cellular stress response and catabolism reinforcing the~     risk for perioperative denutrition.~      In this study, we thought to investigate the change in body composition during the~     perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis~     (BIA).~   "
69792|NCT02143856|"~     The purpose of the study is to evaluate the amount of compound present in the blood~     (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule~     formulation in fasted versus fed conditions in male healthy subjects.~      Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule~     formulation under fasted and fed conditions will be assessed.~   "
69793|NCT02143843|"~     The purpose of this study is to evaluate safety and comfort of the ForSight VISION5 product~     when used for up to 13 months.~   "
69794|NCT02143830|"~     The purpose of this study is to determine whether the use of lower doses of busulfan and the~     elimination of cyclosporine will further reduce transplant-related side effects for patients~     with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related~     or matched unrelated donors following a preparative regimen of busulfan, fludarabine,~     anti-thymocyte globulin and cyclophosphamide.~   "
69795|NCT02143817|"~     Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which~     is currently afflicting millions of individuals. The use of the amino acid L-citrulline has~     been suggested as a potential aid for the treatment of CVD by increasing endothelial~     production of Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of~     exercise that is feasible for clinical populations and has been proven to decrease blood~     pressure (BP) and arterial stiffness and increase muscle mass and strength. Therefore, the~     purpose of this study was to investigate if the combination of WBV training (WBVT) plus~     L-citrulline supplementation would induce positive additive effects and would be an~     effective means to ameliorate arterial stiffness, endothelial function, BP and muscle~     strength/mass in postmenopausal women.~   "
69797|NCT02143791|"~     The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM~     neuromodulation system in the management of failed back surgery syndrome or chronic~     intractable pain of the trunk and/or limbs.~   "
69799|NCT02143765|"~     Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent~     K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the~     channel compared with other insulinotropic sulphonylurea receptor ligands, namely~     repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces~     postprandial hyperglycemia and improves overall glycemic control.~      This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The~     purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in~     patients with type 2 diabetes mellitus.~   "
69800|NCT02143752|"~     The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation~     Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking~     Cessation Program. The Meriter Smoking Cessation Program has two interventions, the~     Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention.~     Study activities include one 10-minute study visit and two 5-minute survey phone calls.~   "
69801|NCT02143739|"~     The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma~     patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).~   "
69802|NCT02143726|"~     This randomized phase II trial studies the effects, good and bad, of using everolimus along~     with sorafenib tosylate versus sorafenib tosylate alone in treating patients with advanced~     radioactive iodine refractory thyroid cancer. Sorafenib tosylate and everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition~     of everolimus to sorafenib tosylate may cause more shrinkage of thyroid cancer and may~     prevent it from growing but it could also cause more side effects than sorafenib tosylate~     alone. It is not yet known whether this treatment with sorafenib tosylate and everolimus is~     better, the same, or worse than sorafenib tosylate alone.~   "
69803|NCT02143713|"~     A randomized study evaluating the continued safety and efficacy of elagolix in the~     management of moderate to severe endometriosis associated pain in adult pre-menopausal~     female subjects who completed 6 months treatment in Study M12-671.~   "
69804|NCT02143700|"~     Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment~     in functionality and in the execution of activities of daily life. The hypothesis of this~     study is to examine the relationship between cognitive status and clinical profile~     (respiratory, sleep quality, nutritional status) in patients with chronic obstructive~     pulmonary disease in two different moments: exacerbation or stable situation.~   "
69805|NCT02143687|"~     The purpose of this study is to investigate the effect of travelling to moderate altitude~     and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance~     of patients with pulmonary hypertension or with interstitial lung disease.~   "
69806|NCT02143674|"~     Introduction: The life expectancy and the number of people hitting the old age have~     increased in recent years. The aging process is accompanied by morphological and functional~     changes that contribute to reduced functional capacity, increase the number of falls and the~     appearance of physical limitations. Exercise promotes maintenance of functional autonomy,~     improving the physical ability of the elderly making it more independent.~      Objective: To evaluate the effect of a program of muscle strengthening exercises associated~     with global stretching on balance, fear of falling and functional capacity in elderly women.~      Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60~     years were divided into two groups: intervention group (IG, n = 7) submitted to muscle~     strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group~     (CG, n = 5), not submitted to the protocol but were educated about physical exercises.~     Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls~     Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group~     for Latin American Maturity (GDLAM). Data were statistically analyzed within and between~     groups with a significance level of p <0.05.~   "
69807|NCT02143661|"~     The purpose of this prospective observational study is to investigate if mechanically~     ventilated patients who are treated in one of the new intensive care unit (ICU) rooms have~     less delirium compared to patients who are treated in the conventional rooms on the same~     ICU. The investigators will further evaluate the impact on sleep quality, circadian rhythm,~     global cognitive function and general outcome parameters.~      The investigators recorded light and noise conditions in the ICU rooms before start of the~     redesigning process (subproject light and noise in the intensive care unit (LiNo-ICU)). The~     investigators will compare data regarding light and noise in the ICU rooms before and after~     the redesigning process (non-patient related data; ethical vote amendment 08.05.2014).~   "
69808|NCT02143648|"~     The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl~     ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in~     hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and~     tolerability in the study population.~   "
69809|NCT02143635|"~     To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with~     selected advanced tumors characterized by wild-type TP53.~   "
69810|NCT02143622|"~     To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects~     in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell~     carcinoma.~   "
69811|NCT02143609|"~     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a~     stay at moderate altitude on exercise performance of patients with chronic obstructive lung~     disease.~   "
69812|NCT02143596|"~     The investigators studied laboratory measurements and previously identified risk factors to~     identify factors predictors of early deterioration following stroke. A prospective~     observational study of 196 patients with first-time acute ischemic stroke was performed.~     Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These~     patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio~     indicates relative dehydration of the patients. An immediate intervention for such patients~     should be the maintenance of proper hydration.~   "
69813|NCT02143583|"~     Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50~     µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of~     allergic rhinoconjunctivitis during the 2nd following birch pollen season.~   "
69815|NCT02143557|"~     Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment~     requires discontinuation of breast milk feeding, due to the abundance of long chain~     triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective:~     To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of~     chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was~     that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis~     compared to infants fed an MCT based formula which is the current standard of care. Design:~     Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk~     that had been modified by removing the fat layer via centrifugation and adding MCT and~     nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8)~     received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after~     chest tube removal per The Hospital for Sick Children standard chylothorax treatment~     protocol. Outcome measures collected included chyle drainage from chest tubes, weight,~     length and head circumference measurements and estimated energy and nutrient intake.~   "
69816|NCT02143544|"~     The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces~     clinical complications in high-risk patients undergoing cardiac surgery.~   "
69817|NCT02143531|"~     This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in~     controlling established postoperative nausea and vomiting (PONV) in the first 24 hours~     following administration similar to the standard of care ondansetron 4 mg.~   "
69818|NCT02143518|"~     Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is~     thought to play a role in the parasite's degradation of host hemoglobin for use as an energy~     source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in~     challenge studies. This study will evaluate the safety and immunogenicity of two~     formulations of Na-GST-1 in healthy adult volunteers when co-administered with the~     immunostimulant CpG 10104, a Toll-like Receptor-9 agonist.~   "
69819|NCT02143505|"~     Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence.~     The aim of this study is to investigate the effect of supplementation with calcium plus~     vitamin D on the recurrence of colorectal adenomas.~   "
69820|NCT02143492|"~     Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The~     purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor~     specimens that would normally be discarded after surgery.~   "
69821|NCT02143479|"~     A study in which two groups of patients will be analysed; patients converted from Prograf to~     Advagraf within the first 3 months after transplantation and patients converted from Prograf~     to Advagraf between 3 months and 1 year after transplantation.~   "
69822|NCT02143466|"~     The purpose of this study is to determine the safety, tolerability and preliminary~     anti-tumour activity of AZD9291 when given together with one of either MEDI4736, AZD6094 or~     selumetinib in patients with EGFR mutation positive advanced lung cancer~   "
69823|NCT02143453|"~     Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise~     training mode is still unclear. In this study, the investigators compared the health-related~     effects of high intensity interval training versus endurance training in obese children.~   "
69824|NCT02143440|"~     To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients~     who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.~   "
69825|NCT02143427|"~     The efficacy of the computer based Treatment Program for Children with Aggressive Behaviour~     (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) which~     is a child focused social competence training delivered in an individual format will be~     evaluated in a randomized controlled trial with children aged 6 to 12 years with~     peer-related aggressive behaviour.~   "
69826|NCT02143414|"~     This phase II trial studies the side effects and how well blinatumomab and combination~     chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with~     acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells~     and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate,~     methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and~     prednisone may kill more cancer cells.~   "
69827|NCT02143401|"~     This phase I trial studies the side effects and the best dose of navitoclax when given~     together with sorafenib tosylate in treating patients with solid tumors that have returned~     (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
69828|NCT02143388|"~     This is an randomized, controlled, multicenter phase II clinical trial. The purpose of this~     study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with~     or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal~     carcinoma.~   "
69829|NCT02143375|"~     Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and~     cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and~     noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod~     laser on the treatment of PGP in patients.~   "
69830|NCT02143362|"~     The study designed to explore the efficacy and safety of the closed loop of target~     controlled infusion dexmedetomidine combined with propofol for anesthesia with~     intraoperative wake up.~   "
69831|NCT02143349|"~     Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies~     have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both~     animals and humans. It has been suggested that forskolin may also suppress appetite thus~     reduce energy intake and results in weight loss. This study will evaluate the appetite~     suppressant properties of Coleus forskohlii extract. In addition the effect on central~     obesity and risk factors of metabolic syndrome will also be investigated.~   "
69832|NCT02143336|"~     A comparison of skin closure techniques (standard skin closure with staples versus a~     continuous (subcuticular) absorbable suture), to determine if this changes the rate of post~     operative wound infections in elective colorectal surgery patients.~   "
69833|NCT02143323|"~     This study has an open-label, one-sequence, multiple drug administration design. The purpose~     of this study is as follows;~        -  To evaluate the change of liver function according to glutathione s-transferase (GST)~          genotype after the multiple administration of amoxicillin/clavulanate.~        -  To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and~          microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.~   "
69834|NCT02143310|"~     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are~     otherwise known as electronic cigarettes devices/systems. These may look like conventional~     cigarettes but do not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the safety and tolerability of an e-vapour product over two years.~   "
69835|NCT02143297|"~     The sleep apnea hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent~     breathing cessations (apneas) or partial collapses (hypopneas) during sleep. These~     respiratory events lead to deep oxygen desaturations, blood pressure and heart rate acute~     changes, increased sympathetic activity and cortical arousals. The gold standard method for~     SAHS diagnosis is in-hospital, technician-attended overnight polysomnography (PSG). However,~     this methodology is labor-intensive, expensive and time-consuming, which has led to large~     waiting lists, delaying diagnosis and treatment. Blood oxygen saturation (SpO2) from~     nocturnal pulse oximetry (NPO) provides relevant information to detect apneas, it can be~     easily recorded ambulatory and it is less expensive and highly reliable. The investigators~     hypothesize that an automatic analysis of single oximetric recordings at home could provide~     essential information on the diagnosis of SAHS. The aim of this study is two-fold: firstly,~     the research focuses on assessing the reliability and usefulness of NPO carried out at~     patient's home in the context of SAHS detection and, secondly, the study aims at assessing~     the performance of an automatic regression model of the AHI by means of neural networks~     using information from NPO recordings. To achieve this goal, both PSG and NPO studies are~     carried out. A polysomnography equipment (E-Series, Compumedics) is used for standard~     in-hospital PSG studies, whereas a portable pulseoximeter (WristOX2 3150, Nonin) is used for~     ambulatory NPO. NPO is carried out the day immediately before or after the PSG at patient's~     home. Patients are assigned to carry out the NPO study before or after the in-hospital PSG~     randomly. In addition, in-hospital attended oximetry is also performed simultaneously to the~     PSG using the portable pulseoximeter.~   "
69836|NCT02143284|"~     EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on~     the model). These optical properties are to be examined and reviewed in this trial (mainly~     usability and safety)~   "
69837|NCT02143271|"~     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after~     single administration of KHK7580 for secondary hyperparathyroidism in patients receiving~     peritoneal dialysis.~   "
69838|NCT02143258|"~     Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by~     increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic,~     toxic or hormonal causes of intracranial hypertension. It is characterized by headaches,~     tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such~     as CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of~     failure or non-compliance (owing to side effects) of medical treatments (that mainly~     includes weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these~     surgical treatments are limited by relative high complications and recurrence rate. Indeed,~     improvement in visual function after ONSF is often transient and the risk of complications,~     including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With~     no better treatment option, intraventricular or lumbar shunt placement has become the~     traditional treatment for medically refractory IIH, despite poor results. Indeed, series of~     patients with IIH treated with shunt replacement report a complications rate (shunt~     occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a~     failure rate up to 64% within 6 months. As a consequence, shunt revision is often required~     and efficacy of the technique to control the disease is questionable.~      The role of intracranial transverse sinus stenosis in IIH has recently gained a particular~     interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased~     intracranial pressure, some authors believe that the rise in intracranial pressure and its~     effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very~     few complications have been reported in IIH patients with venous sinus stent placement.~   "
69839|NCT02143245|"~     The purpose of this study is to determine the efficacy of retrieving tissue samples via an~     x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure~     using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is~     done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the~     investigators hope to avoid more invasive intervention if it is not needed. Some patients~     may appear to have an infection but once the biopsy is taken and the results are read, there~     may not be an infection and therefore no need for a revision surgery.~   "
69840|NCT02143232|"~     The investigators propose to deploy an interactive device to monitor the patient's recovery~     and vital signs at home after joint replacements. These will be early discharge patients on~     the same day or the next morning. The goal will be to support early discharges by creating a~     safe, controlled, and monitored environment at home.~   "
69841|NCT02143219|"~     Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000~     per year). The median age at diagnosis is 69 and 74 in male and female respectively. When~     the 5-Fluorouracile has been used as a single agent with a limited efficacy during more than~     20 years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival~     (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a~     phase II followed by a phase-III study, a French collaborative group has demonstrated the~     benefit of FOLFIRINOX  regimen versus gemcitabine alone, in terms of median survival (11.1~     versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate~     (31.6 versus 9.4%).~      Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was~     acceptable as a new standard regimen for the majority of patients under the age of 70 with a~     good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (> 70 yo),~     pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may~     be easily performed. The methodology of the study is to use the Bryant & Day statistical~     method, allowing to consider simultaneously as principal objective, the response rate~     (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this~     design is particularly fitting in a study for elderly patients who represent half of the~     pancreatic carcinoma population.~   "
74330|NCT02084407|"~     The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem~     cells in order to study the cardiac alterations induced by CTG expansions.~   "
69842|NCT02143206|"~     This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the~     chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve~     participation in a pulmonary rehab program compared to the Nustep elliptical. The main~     outcome of participation will be measured by the number of exercise sessions the patient is~     able to complete during their pulmonary rehabilitation program. In addition, distance walked~     in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index~     score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both~     groups. It is believed that the new machine will provide better overall outcomes compared to~     the traditional machine.~   "
69843|NCT02143193|"~     This study will compare standard methods of stabilizing a newborn's temperature after birth~     with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will~     look at the effects of each warming method on the timing of newborns' initial bath and the~     effects on newborn initiation and percent weight loss by discharge.~      The study will use a randomized controlled trial (RCT) design to test a clinical~     intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to~     the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately~     after vaginal birth, or to the control group (CG), which will receive standard care for~     newborn and mother immediately after vaginal birth.~      This study will test the hypothesis that mother-baby STS contact implemented immediately~     after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS~     (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's~     temperature stabilizes after the initial bath will result in:~        1. Improved newborn temperature stability and thermoregulation for newborns whether breast~          or formula-fed.~        2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the~          addition of at least one more breastfeeding within four hours of birth for breastfed~          newborns.~        3. Avoidance of newborn weight loss of 10% or greater.~   "
69844|NCT02143180|"~     Our study is a prospective multicenter research and the aim is to explore a variety of~     suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get~     the corresponding diagnosis threshold, with the domestic common pathological S stages as the~     gold standard.~   "
69845|NCT02143167|"~     Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately~     40% of MS patients suffering from this by overcoming partly or total conduction block due to~     demyelination.~      Resistance training has been shown to provide the same kind of benefits for patients by~     targeting the muscular component of the motor unit. Thus by combining the two it is likely~     to see an synergistic effect.~      This trial is designed as a double blind, randomized placebo controlled trial with~     subsequent cross-over.~      Participants in the two arms will go through the same progressive training program targets~     at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives~     placebo. in the the end there is another four weeks of training after cross-over has been~     performed.~   "
69846|NCT02143154|"~     While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the~     mechanism by which these drugs prevent neonatal GBS is not well established. One postulated~     theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing~     fetal exposure during labor and delivery. To our knowledge, the relationship between~     vancomycin and vaginal GBS colony counts has never been studied. In this prospective cohort~     study, our objective is to determine the relationship between intrapartum IV vancomycin and~     vaginal GBS colony counts.~   "
69847|NCT02143141|"~     The investigators are attempting to see if eliminating the amount of long acting spinal~     narcotic during cesarean section delivery will demonstrate pain scores with movement when~     evaluated 24 hours postoperatively as those that receive the standard dosage of spinal~     narcotic when combined with oral acetaminophen or placebo. The investigators also are~     evaluating if there are decreased side effects related to decreased narcotic usage.~   "
69848|NCT02143128|"~     Using clinical experience and brain storm method the investigators picked up and~     digitalized information about mental, postoperative nausea, vomiting and pain status at the~     rest and during mobilization in so called Efficacy Side-effect Score (ESS) Depending on~     expression of patient's complaints, all mentioned above clinical features are scored up from~     0 to 10-15 and summarized in the total score. This score is now to be validated and~     re-developed to be used as a tool for improving safety and quality of postoperative care.~   "
69849|NCT02143115|"~     The goal of this study is to compare the findings of virtual (CT-colonography) with findings~     of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal~     cancer surveillance.~   "
69850|NCT02143102|"~     The investigators use MRI and/or CT to evaluate the extent, as well as, the structure,~     composition, and functional aspects of atherosclerotic plaques in human carotid and femoral~     arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular~     beds as part of their routine clinical care.~   "
69851|NCT02143089|"~     Use versus non use of urinary catheterization during Second Elective caesarean delivery:~   "
69852|NCT02143076|"~     Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as~     prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help~     manage SCD. Electronic adherence monitoring is widely considered the gold standard in~     objective adherence measurement. These monitors provide continuous, real-time records of~     medication adherence and reveal problematic behavior patterns, including underdosing,~     overdosing, delayed dosing, drug holidays (i.e. where individuals do not take medications~     for a specified interval of time), and white coat adherence (i.e., a pattern of drug~     adherence as a function of time where individuals display good adherence immediately before~     and after clinic attendance with worsening adherence in the period between).~      Overall, electronic adherence measures are considered valid, reliable, and accurate, with~     clear advantages over pharmacy refill records, physician estimates and self-report measures.~     Currently, only one electronic measure capable of monitoring medications in both pill and~     liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding~     its validity and reliability, preliminary data support the use of Wise technology to measure~     adherence to medication. The current study will determine the Wise device's ability to~     feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD~     population.~   "
69853|NCT02143063|"~     Reinforcement interventions have pronounced effects on reducing cocaine use. This study will~     evaluate a novel approach in which reinforcement frequency varies by patient performance. To~     test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard~     care, standard care plus traditional twice weekly reinforcement, or standard care plus~     adaptive variable interval reinforcement.~   "
69854|NCT02143050|"~     The main purpose is to evaluate the clinical response, safety and survival of the FDA~     approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators~     hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with~     the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity~     and improve clinical outcomes in terms of objective response rates and survival in~     metastatic melanoma patients.~   "
69855|NCT02143037|"~     Contingency management (CM) is highly efficacious for reducing substance use, and recent~     data suggest that reinforcing attendance at treatment can significantly improve treatment~     outcomes. Importantly, CM interventions that reinforce attendance are more likely to be~     adopted clinically than those that reinforce abstinence. Having objective indicators of~     drinking outcomes, nevertheless, is critical for quantifying the benefits of~     attendance-based CM treatment in alcohol abusing populations. New technology is now~     available to gauge alcohol use in patients' natural environments. The Secure Continuous~     Remote Alcohol Monitor (SCRAMx®) continuously monitors alcohol consumption 24 hours a day.~     As such, it may be ideal for objective evaluation of alcohol consumption during treatment~     intervention studies, including those that involve CM.~      In this study, 114 patients participating in community based outpatient treatment programs~     for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to~     standard care or standard care plus CM, with reinforcement contingent upon attendance at~     treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and~     self reports. The investigators expect that patients randomized to the CM intervention will~     remain in treatment longer and show reductions in both SCRAMx assessed and self reported~     drinking days relative to those randomized to standard care.~   "
69856|NCT02143024|"~     Despite the public health importance of clinical depression, more than 50% of depressed~     adults receive inadequate or no treatment, with even higher rates of under-treatment in men~     and minorities. Family members and/or friends often assist older adults in their health care~     and may help overcome barriers to formal care, yet there is a lack of primary care-based~     interventions that mobilize family members and friends to improve depression treatment. In~     partnership with a community-based clinic, this research will address this scientific gap by~     developing and then testing the feasibility and acceptability of a family-based intervention~     that can be delivered pragmatically in a primary care setting serving large numbers of older~     minorities.~   "
69857|NCT02143011|"~     The main objectives of this study are to test the hypotheses that: 1) consumption of~     beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a~     greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic~     psychological stress may augment the adverse metabolic effects of sugar intake. The study~     intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a~     sucrose-sweetened beverage or naturally-sweetened orange juice.~   "
69858|NCT02142998|"~     Obesity has become a significant health problem in Canada. It is known to be a risk factor~     for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts~     to lose weight fail, patients often consider bariatric surgical procedures as the next step.~     The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and~     Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal~     pH monitoring, as it is the most objective method to document the reflux, assess the~     severity and monitor the response to treatment of the disease. In the last few years LSG has~     gained in popularity due to its simplicity and short operative time. Currently the~     comparison between bariatric surgery and GERD symptoms is very one sided. There are~     significant numbers of studies with conclusive results that state that LRYGB has a positive~     effect on GERD symptoms, however there is little evidence that states the same about LSG.~     This means that the relationship between LSG and GERD is inconclusive. An objective~     evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up~     time points will contribute greatly to our understanding of what this relationship might be.~   "
69859|NCT02142985|"~     Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be~     difficult in some situations and need to be confirmed with other investigations such as semi~     invasive cardiac output measurement based on the Flo-Trac receptor and the Vigileo monitor.~      Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness~     to fluid filling maneuver in patients with hemodynamic instability.~   "
69860|NCT02142972|"~     The aims of this study are to investigate whether pelvic pain and low back pain disability~     are associated with postpartum depression and to compare the prevalence between women~     without Low back pain and disability and women with Low Back Pain (LBP) and disability every~     trimester, and correlate postpartum Depression and some clinical and biopsychosocial~     variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in~     a cohort of Spanish women at 2 months postpartum.~   "
69867|NCT02142881|"~     To date, most observational and all intervention studies have defined hypertension on the~     basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or~     ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause~     mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive~     (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal~     ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and~     sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of~     patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP~     (masked hypertension). We demonstrated that, among participants from the Chronic Renal~     Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and~     elevated proteinuria are associated with increased odds of masked hypertension.~     Additionally, participants with masked hypertension had increased risk for target organ~     damage as assessed by left ventricular mass and pulse wave velocity. These results in~     participants with CKD are consistent with prior studies in patients with normal renal~     function that demonstrated a two-fold increased risk for cardiovascular events in patients~     with masked hypertension compared to patients with normal clinic and ambulatory BP. Despite~     this elevated risk for adverse outcomes, patients with masked hypertension have been~     excluded from hypertension trials because of their normal clinic BP. Therefore, it is~     unknown whether the reduction in target organ damage and adverse cardiovascular outcomes~     associated with treatment of hypertension extends to patients with masked hypertension. To~     address this important gap in knowledge, we are planning a randomized, controlled trial to~     evaluate whether antihypertensive treatment can modify BP patterns in patients with masked~     hypertension, that is, convert them to controlled clinic and ambulatory BP. We will also~     evaluate the effect antihypertensive treatment on target organ damage in patients with~     masked hypertension. The current study is a pilot randomized controlled trial to evaluate~     the feasibility of the planned trial and the effect of antihypertensive therapy on clinic~     and ambulatory BP, proteinuria, and target organ damage in patients with masked~     hypertension.~   "
69861|NCT02142959|"~     Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation~     therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to~     its direct physical complications and the resulting impact on overall quality of life, it~     can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation~     therapy. The most common strategy employed in an attempt to prevent or minimize radiation~     dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the~     area clean, and minimizing exposure to potential mechanical irritants, such as scratching~     and rough clothing. However, this strategy has been shown to lack clinically significant~     efficacy. Consequently, there is a clinical need for new treatments that are effective in~     protecting against radiotherapy-induced oxidative stress and the subsequent development of~     radiation dermatitis.~      Based on data from previous studies in animals and humans, Reata believes that omaveloxolone~     (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology~     patients undergoing radiation therapy.~      This randomized, double-blind, vehicle-controlled, parallel-group trial will study the~     efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion~     (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is~     recommended.~   "
69862|NCT02142946|"~     The primary objective of this project is to track changes over time in balance control~     parameters measured during stance and gait for different groups of multiple sclerosis (MS)~     patients. Our primary goal is to determine whether these changes in balance control over~     time predict transitions in MS progression to a more disease affected state, and are~     different from changes over time for patients with balance deficits due to vestibular~     sensory disorders. A part of this goal is also to determine whether these changes in balance~     control are correlated with changes in patients' self-reported deficits and are similar to~     those changes in balance control of patients with peripheral vestibular loss. The secondary~     objective is to determine for multiple sclerosis (MS) patients the relationship of their~     balance parameters to different gait speeds, in order to advise them on, and promote via~     feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better~     tracking of MS disease changes over time, earlier quantification of onset of symptoms~     suggesting a worsening of disease status, and, we assume, greater patient satisfaction~     knowing that quantification of symptoms fits subjective feelings of balance deficits during~     stance and gait. Achieving the second objective would lead to improved balance during gait.~     We aim to carry out these objectives using equipment (SwayStar) which we have proven is~     sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain~     than previously used quantification tools. We aim to investigate the balance deficits during~     gait in different MS patient groups using a multimodal approach with a SwayStar system~     (analysis of balance during stance and gait in terms of trunk-pelvis movements near the~     centre of mass) and patient questionnaires.~   "
69863|NCT02142933|"~     1. At the University Hospital Basel, Switzerland, a simplified screening for group B~          streptococci (GBS) of vagina and perineum has been performed since several years.~          Reliable detection of GBS is critical to prevent GBS transmission during delivery with~          antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to~          severe infection and complications in the neonate. Centers for Disease Control and~          Prevention (CDC) and other international organizations recommend a vaginal and~          additional rectal swab.We therefore aim to test this simplified screening against the~          international gold standard.~        2. Antibiotic resistant bacteria may reside in the genital tract of an expected mother and~          may be transmitted to the new-born during delivery. In case of infection of the~          pregnant woman or the neonate, application of standard antimicrobial treatment will~          insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria.~          Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver~          adequate antimicrobial treatment.~   "
69864|NCT02142920|"~     The purpose of the study is to characterize how PF-05212384 is metabolized in the body~     following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).~   "
69865|NCT02142907|"~     In a general radiation oncology practice, breast cancer typically comprises approximately~     25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical~     mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving~     surgery followed by radiation therapy to the intact breast is an established standard of~     care for the majority of women with early stage invasive breast cancer. Recommended~     techniques for breast-conservation treatment are local excision of the primary tumor,~     preferably with clear margins, axillary lymph node dissection, and breast irradiation (45 to~     50 Gy), usually with a boost (10 to 20 Gy, depending on tumor size and status of the~     surgical margins).~      The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5~     weeks in post lumpectomy patients of early stage breast cancer, following whole breast~     irradiation (WBI).~      The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast~     cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either~     electron beam therapy or 3D CRT. The primary end point of the study will be assessment of~     acute and late radiation toxicities, cosmetic score analysis and local control between two~     schedules. Secondary end points will be recurrence-free survival.~   "
69866|NCT02142894|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
69868|NCT02142868|"~     To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative~     advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line~     patients only).~   "
69869|NCT02142855|"~     The first goal of this study is the follow young and older people over a period of 8 weeks~     to define the processes responsible for loss of muscle length and width in age-related~     muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon.~     Secondly, we will assess two different exercise interventions for reversing human~     sarcopenia; one which involves shortening of the muscle and the other which involves~     lengthening, whilst also studying why these exercises work the way they do. This project~     will have significant implications for our understanding of the control of skeletal muscle~     and tendon size in humans, particularly in relation to sarcopenia and the surrounding health~     issues.~   "
69870|NCT02142842|"~     Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.~   "
69872|NCT02142816|"~     Targeting the amount of fluid given to measurements of the patients own fluid status during~     major abdominal surgery has been linked with improved speed of recovery of gut function and~     reduced length of hospital stay, mortality and complications.~      Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more~     invasive forms of monitoring to direct how much fluid to give.~      The study aims primarily to measure and compare how much fluid is given when guided by PVI~     compared to the established technique; oesophageal doppler during major abdominal surgery.~      The study will compare 40 patients undergoing major elective abdominal surgery. Patients~     will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily,~     the study will examine biochemical markers, length of hospital stay and how frequently~     complications occur~   "
69873|NCT02142803|"~     This phase I trial studies the side effects and best dose of raptor/rictor-mammalian target~     of rapamycin (mTOR) (TORC1/2) inhibitor MLN0128 when given in combination with bevacizumab~     in treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has~     spread and not responded to standard treatment. TORC1/2 inhibitor MLN0128 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Bevacizumab may also stop the progression of tumors by blocking the growth of new~     blood vessels necessary for tumor growth.~   "
69874|NCT02142790|"~     This is a open-label study in patients with metastatic breast cancer to evaluate the~     antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to~     3-weekly regimen.~   "
69875|NCT02142777|"~     The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's~     Disease (AD).~   "
69876|NCT02142764|"~     Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the~     central nervous system. In spite of many works, the data in the literature concerning the~     antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.~   "
69877|NCT02142751|"~     Enterobacterieaceae (and specially Escherichia coli) showing resistance due to~     multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused~     by chromosomal mechanisms have spread worldwide during the last decades. This is important~     because many of these isolates are also resistant to other first-line agents such as~     fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this~     condition is associated with increased morbidity- mortality and length of hospital stay.~     While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia~     coli and AmpC producers, recent data suggests that certain alternatives may be suitable for~     some types of infections.~      At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for~     the treatment of invasive infections due to multidrug-resistant Escherichia coli is~     critical. Fosfomycin was discovered more than 40 years ago but was not investigated~     according to present standards, and thus is not used in clinical practice except in~     desperate situations. It is one of the so-considered neglected antibiotics with high~     potential interest for the future.~      With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared~     to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused~     by multidrug-resistant Escherichia coli . The investigators propose a real practise~     randomised, controlled, multicentre phase III clinical trial to compare the clinical and~     microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with~     meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted~     therapy of the previously specified infection; change to oral therapy according to~     predefined options is allowed in both arms after 5 days. Follow-up for the study is planned~     up to 60 days.~   "
69878|NCT02142738|"~     This is an efficacy and safety study to assess pembrolizumab (MK-3475/SCH 900475) compared~     to standard of care (SOC) platinum-based chemotherapies in the treatment of participants~     with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing~     Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that~     participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as~     assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when~     treated with pembrolizumab than when treated with platinum-based chemotherapies.~   "
69879|NCT02142725|"~     The purpose of this study is to compare two different dosing regimens of phosphatidylcholine~     versus placebo for the induction of remission in ulcerative colitis patients non-responsive~     to standard mesalamine treatment.~   "
69880|NCT02142712|"~     Stroke is the 4th leading cause of death in United States with an estimated 1 death every 4~     minutes. On average, someone suffers from stroke in United States every 40th second. Stroke~     recurs in 1 out of 4 stroke patients. About 87% of the strokes are as a result of ischemic~     insult. The total economic burden from stroke accounts to 38.6 billion dollars per year.~     Stroke is also one of the leading causes of long term disability. Current stroke therapies~     concentrate mainly on acute revascularization, sub-acute rehabilitation and secondary~     prevention.~      Neuroprotection is not the mainstay of treatment modality as there are no effective regimen~     which has satisfied stroke clinicians and researchers. Many neuroprotection agents have~     shown excellent pre-clinical results but have failed in clinical translation. Thus we need~     to find new treatments in order to decrease the mortality and morbidity caused by stroke.~      The investigators hypothesize that adopting a narrower therapeutic window, with treatment~     initiation in the first six hours, may demonstrate a positive or significant short and long~     term neuroprotective effect from NMDA/Glutaminergic or histaminergic antagonism when~     compared with standard of care.~   "
69893|NCT02142543|"~     This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to~     evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous~     stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of~     less than 48 hours duration. It was randomly determined which powder was used first; all~     subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder~     twice daily and maintained a daily log recording the size of the ulcer, its erythema score,~     and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer~     was resolved.~   "
69894|NCT02142530|"~     This research study is evaluating a drug called carfilzomib used in combination with another~     drug called belinostat with participants who have relapsed or refractory non-Hodgkin~     lymphoma (NHL).~   "
69964|NCT02141581|"~     The purpose of this study is to investigate the effect of different licensed influenza~     vaccines including 2011-2012 formulation of trivalent inactivated influenza vaccine (TIV)~     delivered by different routes intramuscular(IM) and intradermal(ID) and 2011-2012~     formulation of live attenuated influenza vaccine (LAIV) administered intranasally~     administered in generally healthy male and female volunteers. The goal is to develop and~     apply assays to characterize the human immune response to influenza vaccination, and to~     compare responses to mucosal vs. systemic vaccination.~   "
69881|NCT02142699|"~     A recent analysis of over 4500 cardiac surgical patients at the Royal Infirmary of Edinburgh~     has confirmed that acute kidney injury (AKI) is not only a relatively common post-operative~     complication but is associated with prolonged hospital stay, and increased risk of death.~     There is currently no specific therapy available except supportive care.~      In laboratory studies, heme arginate (HA), a drug licensed for human use, has been shown to~     upregulate the anti-inflammatory enzyme hemeoxygenase-1 (HO-1) and protect aged mice from~     acute kidney injury.~      This study will bring this research into the human arena. It will aim to evaluate the~     minimum effective dose of HA and verify its safety in this specific group of patients. This~     will be the next step in investigating if HA could be a potential protective treatment for~     reducing AKI in patients about to have cardiac surgery.~      Patients who are due to have cardiac surgery and are aged 60 or above will be approached for~     inclusion in the study. If agreeable, they will be randomly assigned to receive either HA at~     a dose of 1mg/kg or 3mg/kg. There will be 10 patients in each group.~      Blood tests will be taken just before the study drug is given, at 6 hours, 24 hours and 7~     days post dose. These samples will be used to examine the effect of HA on HO-1 at different~     doses, and will verify drug safety. Any adverse effects of the drug will be evaluated,~     although HA has an excellent safety profile when used as it is currently licensed for acute~     porphyria. Urine samples will also be collected to assess inflammation and quantify urinary~     biomarkers of AKI. This will set the scene for a randomised clinical trial of HA in cardiac~     surgical patients at high risk of AKI.~   "
69882|NCT02142686|"~     The aim of this study is to compare different filling pressures~   "
69883|NCT02142673|"~     The study aims to compare different filling pressures in operative outpatient hysteroscopy.~     Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine~     cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in~     group1, 60mm Hg in group 2 and 40mmHg in group 3.~   "
69884|NCT02142660|"~     The application of SprayShield during a laparoscopic band removal (first surgical step) will~     be evaluated to see if the postoperative adhesions between the stomach, the left liver and~     the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or~     a sleeve gastrectomy.~   "
69885|NCT02142647|"~     Current research shows that dairy protein accelerates infant weight gain, which is a risk~     factor for later on obesity and metabolic syndrome. However, dietary protein from other~     sources haven't been studied yet. This longitudinal study will compare two complementary~     feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body~     composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy~     infants at approximately 5 months of age will be randomized to either a meat protein, or a~     dairy protein group with complementary protein mainly from meat or dairy. Infants will~     consume one of these diets for 7 months (6-12 months of age) and infant growth, body~     composition, growth biomarkers and gut microbiome will be measured to compare between groups~     and over time.~   "
69886|NCT02142634|"~     The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of~     active incomplete microscopic colitis.~   "
69887|NCT02142621|"~     Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth.~     It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants~     with birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes~     including chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe~     BPD, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36~     weeks postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae.~     Recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to~     the development of these impairments. Gastroesophageal reflux (GER) contributes to these~     mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately,~     clinically available methods to diagnose GER in infants are unreliable. Moreover, acid~     suppressive agents are both ineffective and carry high risk of serious life-threatening~     morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.~      This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway~     complications of GER and and whether this methodology can aid in identifying individual~     infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.~      Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared~     to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome)~     and improve a validated BPD severity score (secondary outcome).~      The investigators hypothesize that 80% percent of enrolled infants will have significantly~     fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and~     will have this feeding method formally recommended.~      Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric~     compared to gastric feeds reduce airway complications of GER in infants with severe BPD.~      The investigators hypothesize that transpyloric compared to gastric feeds will be associated~     overall with a 15% reduction in number of daily intermittent hypoxemic events.~   "
69888|NCT02142608|"~     Pilot study to evaluate the sensitivity and specificity of BR55 targeting for prostate~     cancer nodules with Gleason score greater than or equal to 7.~   "
69889|NCT02142595|"~     The investigators designed a study to determine whether dexmedetomidine versus midazolam~     combined with spinal anesthesia would provide same postoperative sleep quality in patients~     undergoing transurethral prostatic resection.~   "
69890|NCT02142582|"~     Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home~     Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid~     loss due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these~     patients. The investigators believe that taste of the standard ORS is the biggest reason why~     these patients are not complaint. The new ORS in the market has been prepared with this in~     mind. The investigators want to study if this new ORS will improve the compliance in this~     patient cohort.~   "
69891|NCT02142569|"~     The purpose of this study is to determine the effects of a palm-oil derived tocotrienol~     (TRF) supplement or Chinese red yeast rice (CRYR) individually and in combination on blood~     cholesterol, and particularly LDL cholesterol, in individuals who have either elevated or~     normal cholesterol levels. Tocotrienols are members of the vitamin E family, and are found~     in barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols~     is palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL~     (or 'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol.~   "
69892|NCT02142556|"~     Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR)~     in patients with schizophrenia switched from other antipsychotics which were suboptimal due~     to insufficient efficacy or insufficient tolerability.~      Methods:~      This was a 12-week, open-label study conducted in the Chinese population in Taiwan.~     Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after~     day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within~     400-800 mg per day, depending on the clinical response and tolerability of the patients.~   "
69895|NCT02142517|"~     Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and~     also affect significantly the surgical outcomes . The incidence of POPF after~     pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and~     mortality after pancreaticoduodenectomy are usually related to surgical management of the~     pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues~     to be a challenge at high volume centers. The variety of reconstruction is a reflection of~     the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many~     studies compared both techniques, but their surgical outcomes still unclear.The aim of the~     study was to assess the effectiveness and surgical outcomes of both techniques of PJ after~     pancreaticoduodenectomy.~   "
69896|NCT02142504|"~     The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like~     particle (VLP) vaccine for further development by assessing the rates of serious adverse~     events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs,~     Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from~     the trial.~   "
69897|NCT02142491|"~     The objective of this study is to verify the clinical tolerance to the vaccine Flumist~     (intranasal live attenuated influenza vaccine) in a population of egg allergic children.~     More specifically, the investigators want to estimate the risk of severe allergic reaction~     arising within 24 hours following the vaccination of egg allergic with Flumist.~   "
69898|NCT02142478|"~     Physical activity (PA) benefits both physical and psychological health, yet the majority of~     UK adults are physically inactive. Exercise for Health (EFH) is a General Practitioner~     (GP) exercise referral scheme run in Liverpool for people who are inactive with a medical~     condition. Patients are referred by their GP practice, where they receive 12 weeks of~     subsidised exercise classes at their local leisure or community centre.~      In 2012, one of the thirteen EFH centres (Centre A) introduced some changes to try and~     improve EFH at their centre. These changes included:~        -  a pre-scheme meeting with a health trainer, to help the patient decide if EFH is for~          them.~        -  exclusive classes (gym or activities) available daily for EFH participants (compared to~          gym only classes two or three times a week in other centres).~      This non-randomised study will compare the effectiveness of the adapted EFH (Centre A) with~     standard EFH delivery (Centre B). All participants referred to centre A (n=100 approx) or~     centre B (n=100 approx) during the study period will be invited to take part. Changes in~     self-reported PA, PA self-efficacy and psychological wellbeing will be measured at the end~     of EFH (12 weeks) and at 12-month follow-up. A subsample of participants (n=15 from each~     centre) will take part in qualitative interviews to explore the factors that contribute to~     effectiveness.~      A secondary aim is to explore psychological factors contributing to any differences between~     the two centres. Self-determination theory suggests that where participants feel they are~     offered choice, feel they are competent at exercise, and feel connected to people they~     exercise with, they will be more intrinsically motivated and more likely to continue~     exercising. Therefore it is hypothesised that participants attending the adapted EFH will be~     more motivated and more likely to continue exercising.~   "
69899|NCT02141867|"~     We will conduct a 7 day cohort study of consecutive patients aged 16 years and older~     undergoing inpatient noncardiac surgery. Patients will be followed up for a maximum of 30~     days. We will follow the original European Surgical Outcomes Study (EuSOS) study design.~      The primary outcome is in-hospital mortality. Secondary outcomes include length of stay and~     admission to intensive care. Centres across South Africa representing the public service~     will recruit patients. This study will run from 19 May 2014 to 26 May 2014.~   "
69900|NCT02141854|"~     Study drug and placebo will be supplied in Teva multidose dry powder inhaler (MDPI) devices~     and provided for participants to use at home. Participants will perform spirometry at every~     visit. Each participant will be given a diary at each visit for use until the next visit.~     Rescue medication (albuterol/salbutamol) will be dispensed at each visit, if needed, as~     determined by the investigational center personnel.~   "
69901|NCT02141841|"~     This study was performed in 131 adult patients undergoing transurethral, urological or lower~     limb surgery under combined spinal and epidural anesthesia. Patients were stratified~     according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component~     of the anesthetic was established by bolus administration of up-and-down doses of 0.75%~     plain bupivacaine, determined by Dixon's method. The degree of motor block after intrathecal~     administration of each concentration was evaluated by the modified Bromage and Hip motor~     function score. The EC50 were estimated from the up-and-down sequences using the method of~     Dixon and Massey and logistic regression. Other endpoints were included on the basis of~     sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.~   "
69902|NCT02141828|"~     A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia~     (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or~     fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called~     DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a~     molecule that blocks the activity of DOT1L, and is therefore being evaluated in the~     treatment of patients with MLL-rearranged leukemias.~   "
69903|NCT02141815|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiota contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, overall mortality and chronic kidney disease progression. The most~     important regulator of colonic bacterial metabolism is nutrient availability and especially~     the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake~     of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides~     (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing~     effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in~     general, and AXOS more specifically, can influence intestinal generation of microbial~     metabolites in predialysis patients has not been studied to date. An interventional study~     with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease~     intestinal generation and serum concentrations of microbial metabolites in patients with CKD~     not yet on dialysis.~   "
69927|NCT02142257|"~     The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy~     over 5 years of treatment with regards to weight loss, quality of life, complications,~     adverse events, and health economics.~   "
69928|NCT02142244|"~     Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis~     (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the~     standard procedure - a fluorescent contrast (indocyanine green) using special light (near~     infra-red) - looking for more precise diagnosis of the presence of the lymph node~     metastasis.~   "
69904|NCT02141802|"~     Children with cerebral palsy commonly use standing frames to position them to help prevent~     contracture and deformity and to help their function. There is a lack of evidence to support~     the correct dosage of standing frame use.~      The aim of this study is to pilot a randomised controlled trial of the clinical effects of~     doubling the duration of standing, using standing frames, in young children who are unable~     to walk, who have cerebral palsy or developmental delay.~      It will determine whether it is feasable to carry out a multi-centred trial.~      The study objectives will be to determine:~        1. presence of adverse events~        2. recruitment and drop out rate~        3. compliance with the intervention~        4. feasibility of the randomisation and minimisation process~        5. the proportion of the outcome measures taken~        6. effect size estimate~        7. required study costs~        8. effectiveness of blinding procedure~   "
69905|NCT02141789|"~     Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders~     and/or depression. Anxiety and depression influence the course and treatment of alcohol~     dependence and are a major risk factor for alcohol relapse within the first three months~     after detoxification. Therefore, there is need for combined treatment (integrated therapy)~     of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression.~     Until today, there are no systematic outpatient treatment offers for this special group of~     patients in Germany. In this study we want to investigate if integrated outpatient cognitive~     behavioral therapy can prevent and decrease alcohol relapse within the first three months~     after detoxification. Therefore we hypothesize that immediate start of integrated outpatient~     psychotherapy will reduce relapse variables compared to treatment as usual which is~     characterized by non-immediate start of therapy due to the required application for~     insurance coverage.~   "
69906|NCT02141776|"~     Major depressive disorder (MDD) is a significant public health problem. Existing treatment~     modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is~     a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive~     brain stimulation technique, has been shown to be effective in alleviating depressive~     symptoms in preliminary studies. There is need to explore the role of t-DCS in~     Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this~     exploratory study.~      Aim:~      Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20~     week days) with sham stimulation in alleviating depressive symptoms in patients with TRD.~      Methodology: Patients who seek treatment in our treatment resistant depression clinic and~     who have failed to respond to treatment with two antidepressant medications will be offered~     to enroll in this study. The aim is to study 20 patients who meet the Diagnostic and~     Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the~     ages of 21-65 years. Those subjects that receive sham stimulation will be offered to have~     active t-DCS stimulation for additional 3 weeks to get any benefit that they may have~     otherwise missed by being in the sham stimulation group.~      Results and Conclusions: The investigators will compare the mean baseline and end of~     treatment Montgomery Asberg depression rating scale between the two groups. The~     investigators will compare the change in mean depression scores between the baseline and end~     of treatment in those receiving active t-DCS for a total of 7 weeks duration. This study is~     innovative and of significance in exploring the role of this novel, easy to administer, safe~     and cost effective treatment modality.~   "
69907|NCT02141763|"~     A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body~     distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the~     treatment group.~   "
69908|NCT02141750|"~     The Registry pretends to identify stratification, diagnosis and treatment approaches in~     patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals~     to optimize resources and identify strategies to improve health care quality through the~     creation of clinical guidelines that serve for unify management and treatment methods with~     adherence to international guidelines which include suggestions for treatment and~     medication.~   "
69909|NCT02141737|"~     To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with~     etomidate during general anesthesia in elderly patients~   "
69910|NCT02141724|"~     A retrospective study with the patients having a positioning consultation at hospital,~     between 2009 and 2014. In every neuromuscular disorder, the investigators describe the~     population seen in consultation, the aim of consultation, the postural problem observed in~     wheelchair, pain when sitting in wheelchair, and pressure ulcer.~   "
69911|NCT02141711|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind,~     placebo controlled, sequential panel, multiple-dose schedule.~   "
69912|NCT02141698|"~     The primary purpose of this study was to evaluate the safety, tolerability, and~     pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western~     men, to investigate the effect of food on the pharmacokinetics of TAK-438, and to compare~     the TAK-438 pharmacokinetics of Western with Japanese men.~   "
69913|NCT02142452|"~     The investigators will test the efficacy of a tailored behavioral lifestyle modification~     program to support cardiovascular health in postpartum women with excessive gestational~     weight gain. This program will include a mobile health texting component postpartum to~     support changes in nutrition and physical activity. The investigators will randomize women~     into either the control arm (usual care) or the intervention (usual care + mobile health~     program postpartum). The women will be recruited during their 3rd trimester once they have~     been identified as gaining too much weight according to the 2009 IOM guidelines during~     pregnancy.~   "
69948|NCT02141971|"~     Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged~     30-60 years old. This study will observe 3 different groups: four non-demented subjects~     between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and~     four demented subjects 50-60 years old.~      Currently available longitudinal data in DS suggest a high rate of transition to dementia~     from the late 40s through the early 50s of these individuals. This, together with the~     universal presence of plaques in DS by their mid 40s makes this age range ideal for studying~     the development of AD.~   "
69965|NCT02141568|"~     The purpose of this study is to check the medical efficacy and economic benefits of~     multidisciplinary care in patients with unexplained medical complaints and consume medical~     services frequently.~   "
69914|NCT02142439|"~     Strength training has been found effective for enhancement of bone health, muscle strength~     and body composition among premenopausal women from the general population, however it is~     unclear to what extend strength training might improve these parameters among women with~     eating disorders. The aim of this study is therefore to examine acute and long-term effects~     of strength training among persons with eating disorders. The study is a randomized,~     controlled, single-blinded trial with three intervention groups and one control group. The~     three intervention groups will perform different volumes of strength training. The~     intervention period is 16 weeks with three sessions per week. At pretest, posttest, and 6~     months, 12 months and 24 months follow-up, the following variables will be measured: bone~     health, muscle strength, power, body composition hormone levels, physical activity level and~     compulsivity, body awareness, quality of life, and eating disorders psychopathology.~     Qualitative in-depth interviews will be carried out to explore the participants' experiences~     with strength training. The study is carried out in Norway, and is performed in~     collaboration with Telemark University College, University of Agder, Norwegian school of~     sport sciences and Modum Bad psychiatric center. The results from the study might implicate~     on strength training as part of treatment for eating disorders.~   "
69915|NCT02142426|"~     The purpose of this study was to pursue statistical analysis on a series of molecular~     laboratory results obtained from chronic wounds. It elucidated diversity, quantification,~     and other aspects of microbial diversity in chronic wounds.~   "
69916|NCT02142413|"~     The primary aim of this prospective observational study is to investigate whether an~     enhanced diagnostic MRI work-up (including cardiac MRI, angiography of the aortic arch and~     the brain-supplying arteries) combined with an in-hospital Holter-ECG of up to 5 days~     duration leads to a significant increase in relevant pathologic findings with respect to~     stroke aetiology as compared to the findings obtained by a routine diagnostic work-up~     (including stroke unit monitoring, 24h-Holter-ECG, echocardiography, Doppler-ultrasound of~     the brain-supplying arteries) in patients with acute ischemic stroke and no atrial~     fibrillation according to past medical history or baseline ECG. A better understanding of~     the stroke aetiology may improve secondary stroke prevention and long term outcome.~   "
69917|NCT02142400|"~     This is a randomised, double-blind, placebo-controlled multiple ascending single study. It~     is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week~     treatment period and will result in increases in reticulocyte count and haemoglobin~     concentrations in healthy male volunteers~   "
69918|NCT02142387|"~     Despite aggressive CPR training, the outcome of cardiac arrest is not good. The problem is~     method of education. So, the investigators want to add the dispatcher-assisted CPR~     simulation into conventional CPR training. In this study, the investigators aim is to~     investigate the effect of newer CPR training program.~   "
69919|NCT02142361|"~     Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted~     with Avaira toric silicone hydrogel contact lenses over 1 week of wear.~   "
69920|NCT02142348|"~     To popularize knowledge of prevention and health care of osteoporosis.To investigate the~     prevalence of primary osteoporosis in community residents.~   "
69921|NCT02142335|"~     The purpose of this research study is to test an experimental combination of drugs to~     determine if they can cause shrinkage or even complete disappearance of your melanoma. The~     two drugs being tested in combination are Rituxan and Abraxane~   "
69922|NCT02142322|"~     This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil,~     Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.~   "
69923|NCT02142309|"~     Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus~     algorithms have been developed to help clinicians to select among the numerous medications~     and their combinations for achieving and maintaining a target glycated hemoglobin A1c~     (HbA1c) of <7%.~      AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes~     medications, when combined with metformin, on glycemia-lowering effectiveness.~   "
69924|NCT02142296|"~     Primary Objectives:~      To assess the efficacy of intravitreal administered Eylea in preventing visual loss in~     subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular~     age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared~     to Baseline.~      Secondary Objectives:~        1. To assess the safety and tolerability of repeated intravitreal administration of Eylea~          in subjects with the PED subtype of neovascular AMD for a period of 1 year~        2. To assess the effect of repeated intravitreal administration of Eylea on Central~          Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.~        3. To assess the effect of repeated intravitreal administration of Eylea on vision related~          quality of life in subjects with PED study type of neovascular AMD assessed using the~          NEI/VFQ-25 questionnaire~   "
69925|NCT02142283|"~     The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical~     management leads to superior clinical outcomes at 90 days as compared to medical management~     alone in appropriately selected subjects experiencing an acute ischemic stroke when~     treatment is initiated within 6-24 hours after last seen well.~   "
69926|NCT02142270|"~     Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to~     assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a~     prospective, multicenter, community-based registry monitoring all cases of cardiac arrest~     occurring in victims > 15 years old. Investigators will use the definition of established~     SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid~     witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms;~     probable SCD if an unexpected death without obvious extracardiac cause occurred within the~     previous 24 hours. After approval from institutional boards, Investigators will record~     demographic, clinical, electrocardiographic and biological variables of SCD victims~     (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths~     occurring in residents of districts of interest will be checked for past medical history,~     circumstances of death, and autopsy report (if possible). Investigators will also analyze~     the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA)~     in various patient populations throughout countries. Conclusion This study will provide~     comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will~     help in the development of strategies to prevent and manage cardiac arrest in this region of~     the world.~   "
69929|NCT02142231|"~     Test anxiety is a well-known phenomenon in general population, but only few scientific~     advances have been made in order to fully understand and prevent this circumstance.~      The number of students which use neuro enhancement to improve their performance and to~     prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US~     universities have used prescription stimulants against anxiety, and that on some campuses,~     up to 25% of students had used them in the past year.~      Acupuncture might act as an alternate. Several trials could demonstrate, that different~     forms of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and~     that this therapy was highly safe. In special, the investigation of single point effects in~     test anxiety could be of general interest. The acupuncture point with the most convincing~     evidence up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination~     with other acupuncture points and not as single remedy in test anxiety. Therefore we~     establish a trial investigating the immediate needling effects at Heart 7 on the reduction~     of test anxiety.~      Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which~     is known to provoke serious stress responses in healthy subjects. 24 medical students with~     test anxiety in there history will be randomised to two interventional groups (verum~     acupuncture and laser acupuncture), being treated and then pass this test. Main outcome is~     the increase of cortisol in saliva, which is the standardized measure of stress response~     used in this paradigm.~   "
69930|NCT02142218|"~     The purpose of this program is to provide treatment with nivolumab to subjects with Stage~     III or Stage IV advanced melanoma.~   "
69931|NCT02142205|"~     The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002,~     Tysabri®) in the study population (Russian participants with relapsing remitting multiple~     sclerosis). The secondary objectives are to look at evaluation of severity of relapse,~     hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS),~     functional tests, quality of life self-assessment questionnaires including the short form~     health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29~     (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical~     activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.~   "
69932|NCT02142192|"~     The primary objective of this study is to evaluate the immunogenicity of natalizumab~     (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple~     sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of~     natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on~     relapses and on new magnetic resonance imaging (MRI) lesions.~   "
69933|NCT02142179|"~     The purpose of this study is to estimate the impact of a curriculum intervention on asthma~     knowledge in adolescents of a public school in Salvador-Bahia-Brazil.~   "
69934|NCT02142166|"~     The aim of this study is to improve the usability of biomarkers for the timely prediction of~     new complications following a cerebral hemorrhage, especially in combination with invasive,~     functional and local measurements for patients with aneurysmal subarachnoid hemorrhage~     (SAH). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their~     immediate and longer-term effectiveness.~   "
69935|NCT02142153|"~     F901318 is a potent new antifungal agent for the treatment of systemic fungal infections.~     This study will test it for the first time in man with the objective of assessing its~     safety, tolerability and pharmacokinetic profile.~   "
69936|NCT02142140|"~     The purpose of the study is to examine how well two types of treatment follow up work~     compared to one another:~        1. standard community follow up~        2. medication monitoring plus tailored case management follow up.~      A child's participation will involve 3 months of treatment consisting of medication and~     psychological, behavioural, and academic interventions tailored to their individual needs.~      Following this treatment, the child will be randomly assigned to receive two years of either~     community follow up or medication monitoring plus tailored case management follow up~     delivered by the study team. During both types of follow up, at 6 month intervals, the~     parent and child will be asked to complete interviews with our study personnel and~     comprehensive assessments pertaining to ADHD symptoms and various other areas of~     functioning.~      Parents will also be asked to obtain information from the child's teacher regarding the~     child's functioning at 6 month intervals during the school year.~   "
69937|NCT02142127|"~     Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount~     of drug that is recovered over time via different elimination routes of the body, i.e.,~     whole blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be~     able to demonstrate a (near) complete recovery (≥95 %) of the administered dose.~      A good understanding of the metabolic pathway of the study drug is equally important.~     Mass-balance data, together with metabolic profiles in excreta, are used to characterize the~     biotransformation pathways of a drug and to help evaluate its drug-drug interaction~     potential.~      To this purpose, in this study, blood, urine, and feces are collected to investigate the~     metabolic profile of GFT505, and plasma and urine are collected to investigate the~     non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other~     metabolites will be investigated in plasma and urine according to the radioactivity results.~     Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated~     according to the radioactivity results.~   "
69938|NCT02142114|"~     The purpose of this study is to determine if a smaller needle size reduces discomfort~     suffered by patients both during and following intravitreal injections. It is the~     investigators belief that using a smaller size needle will help patients to be less fearful~     of intravitreal injections and more amenable to treatment. This study will also evaluate the~     effect of needle size on post injection intraocular pressure, to see if smaller needles may~     reduce wound leak and increase the intraocular pressure following injection.~      The investigators hypothesize that subject eyes injected with the smaller size needle will~     result in greater patient comfort both during and after their injection as compared to the~     eye injected with the larger needle. The investigators objective is to reduce any discomfort~     felt by patients who receive intravitreal injections. The investigators also hypothesize~     that the smaller needle will result in higher post injection pressures, and another~     objective is to determine if this can affect patient comfort and increase the risk of~     glaucomatous optic nerve damage.~   "
69976|NCT02141425|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     single ascending doses of ASP015K.~   "
69939|NCT02142101|"~     Gut microbes can influence numerous aspects of human biology. Alterations in the function~     and composition of gut microbial flora (gut microbiota ) have been linked to inflammatory~     bowel disease, chronic inflammation, dyslipidemia, diabetes mellitus, atopic disorders,~     cardiovascular disease, neoplasms, and obesity. However, little is known whether renal~     failure alters the composition of gut microbiota and whether an alteration in the gut~     microbiota of patients with renal failure impacts on the development of co-morbid conditions~     such as accelerated atherosclerosis, abnormal bone mineral metabolism, and chronic~     inflammation that are associated with renal failure. Nonetheless, several lines of evidence~     suggest that renal failure alters the chemical environment of the intestinal lumen, which~     could impose a selective pressure on the growth of certain gut microbes. The investigators~     hypothesize that the gut microbiota of patients with renal failure is different from those~     without renal failure. To test this hypothesis the investigators are conducting a~     cross-sectional study of gut microbiota in patients with different degrees of renal failure~     due to polycystic kidney disease (PKD).~   "
69940|NCT02142088|"~     It has been shown that close control of blood glucose levels in the intensive care unit~     patient has benefits for patient morbidity and mortality rates as well as an impact upon~     discharge times. GlySure has previously completed an evaluation of its intra-vascular~     glucose monitoring system in patients in a surgical ICU environment after cardiac surgery.~     This study seeks to evaluate the same equipment being used in a wider range of patients with~     a range of underlying conditions who require treatment in medical ICU's. The GlySure device~     consists of a sensor that is placed into the patient's blood through a central venous~     catheter. It measures blood glucose levels continuously which allows for more rapid control~     of blood glucose levels to be achieved as compared to existing methods where blood samples~     are taken repeatedly every 15 minutes or so.~      The study is designed to show that the sensor can be used for a protracted period of time,~     giving accurate results when compared to a reference technique using the i-STAT device. The~     investigators intend to show that the device performs safely for the required time within~     the ICU.~   "
69941|NCT02142075|"~     Treatment of infections in critically ill patients remains a significant challenge to~     intensivists world-wide with persisting high mortality and morbidity. Compelling evidence~     suggests that source control of the pathogen and appropriate antibiotic therapy remain the~     most important interventions to improve patients' outcome, the latter including the~     administration of a suitable molecule at an optimized dosage regimen.~      Daptomycin is the first representative of a new family of antibiotics, the cyclic~     lipopeptides. Its bactericidal effect against Gram-positive bacteria, including~     meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in~     critically ill patients having infections due to resistant Gram positive strains.~      Unfortunately, no PK study has been performed in infected critically ill patients without~     renal replacement therapy. A vast array of pathophysiological changes can occur in infected~     critically ill patients, leading to changes in volume of distribution and clearance of~     antibiotics in these patients, which may affect the antibiotic concentration at the target~     site.~      It is therefore important to better characterize daptomycin PK in infected patients with~     various degrees of renal failure in order to define optimal dosing regimens.~      This project aims to identify optimal daptomycin administration schemes in critical care~     patients with various degrees of renal impairment~   "
69942|NCT02142062|"~     The purpose of this study is to demonstrate that IVUS identifies more instances of~     significant iliac and common femoral vein outflow obstruction than multiplanar venography.No~     hypothesis testing is planned.~   "
69943|NCT02142049|"~     This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and~     efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with~     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL). This study is conducted in 2~     parts where treatment will be administered in 3-week (21-day) cycles for 6 cycles. A~     standard 3+3 design will be employed in Part 1 to determine the maximum tolerated dose~     (MTD), which will then define the dose to be used in Part 2.~   "
69944|NCT02142036|"~     The metastatic lesions may be very different from the primary tumor because of intrinsic~     tumor heterogenity, clonal selection through metastatic process and following previous~     cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways~     may respond to inhibitory agents directed against specific aberrations irrespective of tumor~     origin. In the MetAction study, patients will receive therapy based on molecular aberrations~     in the metastatic lesions, actionable target identification (ATI), rather than on~     histological tumor type.~      The ATI rate in an unselected metastatic patient population is uncertain, and response rates~     associated with single-agent ATI based targeted therapy have hardly been reported. In this~     perspective, The MetAction study is essentially a feasibility study aiming to tailor~     metastatic cancer therapy based on genomic profiles.~   "
69945|NCT02142010|"~     The purpose of this study is to evaluate the pathological complete response (pCR) rate in~     breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin~     preoperative regimen.~   "
69946|NCT02141997|"~     This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study~     designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity~     of multiple doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are~     inadequately responding to methotrexate (MTX) treatment.~   "
69947|NCT02141984|"~     Approximately 600 pediatric patients prescribed Humira Injection in usual practice according~     to the approved Korean product label will be registered into this observational study.~     Baseline data will be obtained at enrollment including demographics, underlying diseases and~     complications especially in regard to purified protein derivative (PPD) skin test, chest~     X-ray. At routine visits for Humira Injection administration which will occur according to~     usual medical practice, concomitant medication information and adverse events information~     will be collected for up to 70 days after the last administration of Humira.~   "
69949|NCT02141958|"~     The purpose of this study is to assess the safety and tolerability of ascending doses of a~     novel oral formulation of Fenretinide to adult cystic fibrosis (CF) patients, once-daily for~     21 days (treatment cycle). This study will include up to three (3) dose levels with minimum~     7 day breaks in between treatment cycles. For each dose level, blood samples will be~     collected for exploratory pharmacokinetic (PK) and pharmacodynamic (PD) evaluation.~   "
69951|NCT02141932|"~     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))~     it is important to reveal the underlying cause of the disease. In special it is important to~     reveal if carotid artery stenosis is present as such a finding will directly influence on~     treatment and follow-up.~      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations~     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in~     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for~     semi quantitatively bed-side assessment of the carotid arteries and the heart.~      The investigators aim to study the feasibility and reliability of bed-side assessment of the~     carotid arteries and the heart by pocket-sized ultrasound scanners and the clinical~     influence of this examination when performed by experienced users.~      The investigators hypothesize that a significant proportion of this patient population can~     be clarified bed-side with no need of further imaging procedures for the assessment of the~     carotid arteries and the heart.~   "
69952|NCT02141919|"~     The goal of this phase II clinical trial is to evaluate the efficacy of the completely~     non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy~     proven and growing small renal tumors.~   "
69953|NCT02141906|"~     This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin~     for the treatement of patients with unresectable hepatocellular cancer.~   "
69954|NCT02141893|"~     The aim of this group-randomized trial was to test the effectiveness of a new comprehensive~     program, which the investigators called CALMA -plus, in increasing controller medication use~     and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention,~     plus educational training of physicians and nurses, as well as screening for asthma in~     clinics serving Medicaid island Puerto Rican children with asthma. Because the provider~     training was expected to have an impact on the entire clinical setting where trained~     providers work, as well as the patients using that setting, the investigators randomized~     clinic groups rather than individual patients. The investigators compared the CALMA-Plus~     intervention to a CALMA-only group, which the investigators expected to obtain the same~     benefits as the investigators have previously documented.~   "
69955|NCT02141880|"~     College drinking associated with sporting events is characterized by excess alcohol, along~     with food intake, over the duration of hours has the potential to cause a build up of fat in~     the liver. Fatty liver can increase blood glucose concentrations leading to a prediabetes~     like state.~      The present study will determine how overweight men respond to the over-consumption of~     alcohol/food to identify which characteristics might protect some men from fatty liver,~     while others might be more susceptible to this condition.~      The goal of this work is to determine the direct impact of alcohol/food intake to cause~     acute fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy~     men. Understanding individual susceptibility to alcohol-induced fatty liver will aid in the~     development of strategies designed to help people mitigate these risks.~      Hypothesis is that 5h excess consumption of alcohol and food will increase liver~     triglycerides by 4% or more, in comparison to fasting state.~   "
69956|NCT02141685|"~     The purpose of this research study protocol is to collect imaging data on embryos followed~     to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic~     Hybridization (aCGH) results and ongoing pregnancy rates.~   "
69957|NCT02141672|"~     To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete~     remission after 24 weeks of therapy in subjects with active lupus nephritis.~   "
69958|NCT02141659|"~     To evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation~     treatment-naïve non-metastatic prostate cancer~   "
69959|NCT02141646|"~     This is a randomized controlled trial to contrast an intervention that relies on~     well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention~     that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).~   "
69960|NCT02141633|"~     The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in~     airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime~     non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2)~     compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week~     treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic~     parameters. With this protocol the Investigators will test the hypotheses that a) there is a~     correlation between airway and pulmonary vascular endothelial function within the current~     smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular~     endothelial function in the current smoker group.~   "
69961|NCT02141620|"~     This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine~     as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study~     will be conducted in which the subjective, physiological and reinforcing effects of cocaine~     are evaluated during maintenance on placebo and n-acetylcysteine.~   "
69962|NCT02141607|"~     The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic~     instability, systemic inflammatory response syndrome and multiorgan failure has been~     extensively investigated, but there is no consensus on the trigger mechanisms of tissue~     injury at the molecular level.~      Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they~     are unable to act at the beginning of the cascade, because of the lack of a model~     explaining the molecular basis of shock induced tissue injury and ensuing organ damage.~      The present observational study is aimed at identifying the molecular triggers of acute~     heart failure (HF) induced by shock and to identify inflammatory mediators and markers that~     are activated in shock, with a particular emphasis on the role of uncontrolled proteolytic~     activity.~   "
69963|NCT02141594|"~     Spectrailis optical coherence tomography has come with a new posterior pole asymmetry~     analysis for glaucoma diagnosis. The aim of the investigators study was to assess its~     applicability in diagnosing early glaucoma patients.~   "
69977|NCT02141412|"~     In a prospective randomized clinical trial involving adult patients undergoing elective~     surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3~     doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and~     quality of emergence from anesthesia versus placebo.~   "
69978|NCT02141399|"~     This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.~   "
69966|NCT02141555|"~     First trimester miscarriages are common. When the failed pregnancy does not pass~     spontaneously on its own, it is called a missed abortion. There are several ways in which~     missed abortions are managed, one of which involves administering a medication called~     misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy.~     Misoprostol can be administered in multiple ways but has been traditionally inserted~     vaginally when used for management of missed abortions. Some studies have shown that some~     women are not comfortable with vaginal insertion of misoprostol and prefer oral~     administration. Buccal misoprostol is a way of administering misoprostol by having the~     patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve~     for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in~     medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection~     rate for medical abortion when misoprostol administration was switched from vaginal to~     buccal route combined with routine administration of doxycycline. The efficacy of using~     buccal misoprostol to treat missed abortions has not been studied previously to the~     investigators' knowledge. In this pilot study, investigators aim to test the hypotheses that~     buccal misoprostol is equally effective as vaginal misoprostol in the medical management of~     early pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol~     may be associated with higher rates of gastrointestinal side effect but that patient~     satisfaction will remain equally as high for buccal misoprostol as for vaginal misoprostol.~   "
69967|NCT02141542|"~     This is an open label, phase I trial, testing the combination of Tremelimumab and MEDI3617~     in patients with metastatic melanoma.~   "
69968|NCT02141529|"~     The purpose of this study is to determine whether bipolar intraarticular pulsed~     radiofrequency method has a superiority to unipolar mode in the treatment of chronic knee~     pain.~   "
69969|NCT02141516|"~     The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered~     to subjects from 2 to 17 years of age with increased risk of meningococcal disease because~     either of primary or secondary complement deficiencies or of asplenia or splenic~     dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a~     descriptive control for immunogenicity and safety.~   "
69970|NCT02141503|"~     Background:~      - Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and~     tissues of the body. It can occur in children and adults. Because there is no treatment for~     this disease, researchers want to find out more about it.~      Objective:~      - To learn more about Alpha-mannosidosis.~      Eligibility:~      - People ages 5-60 with Alpha-mannosidosis.~      Design:~        -  Participants will be recruited from patient support organizations and medical genetics~          clinics.~        -  Participants will have 3 study visits, about once a year. A final evaluation will be~          made after 3 years.~        -  Participants will have a medical history and a physical exam.~        -  Blood samples and a urine sample will be collected.~        -  Cerebrospinal fluid will be collected. A small area of the lower back will be numbed~          with medicine. A thin needle will be inserted between the spine bones. About 2~          tablespoons of spinal fluid will be removed.~        -  Brain magnetic resonance spectroscopy (MRS) scans will be done at each visit. MRS uses~          a strong magnetic field and radio waves to take pictures of chemicals in the brain with~          a scanner. The participant will lie on a table that can slide in and out of the~          cylinder. While in the scanner the participant will hear loud knocking noises. They~          will get earplugs or earmuffs to muffle the sound. Medicines might be used to keep the~          participant asleep during the MRS.~        -  Participants will have a skin biopsy at the first visit only. A small area of the~          participant s skin will be numbed. A small circle of skin will be removed with a biopsy~          tool.~   "
69971|NCT02141490|"~     Background:~      People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize)~     to lymph nodes. It is important for your doctor to know if this has occurred but currently~     it can be hard to determine if this has occurred on standard imaging studies like CT or MRI.~     This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved~     by cancer.~      Objective:~      - To see how well Ferumoxytol can detect lymph node metastases in patients with prostate,~     bladder, or kidney cancer.~      Eligibility:~      -Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants will have blood drawn and a physical exam. Their vital signs will be~          measured. They will answer questions about their health and current medications.~        -  Participants should not have a history of iron overload or have an allergy to~          Ferumoxytol.~        -  Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal~          cylinder with a strong magnetic field. Participants will lie on a table that slides in~          and out of the scanner. They will have a standard sensor, known as a coil, wrapped~          around their abdomen to improve the scan. This is like a small blanket with wiring~          inside. Participants will need to lie still on the scanning table for about 1 hour.~        -  Participants will have an ultrasound. This uses harmless sound waves to provide~          pictures of organs or tissues inside the body.~        -  Participants will receive an injection of Ferumoxytol through an intravenous line. A~          very thin plastic tube will be inserted into a vein in order to inject the agent.~        -  Participants will have another MRI and ultrasound 24 and 48 hours after injection.~        -  The study will follow participants medical course for at least 1 year.~   "
69972|NCT02141477|"~     This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to~     test the safety of the combination of omacetaxine and decitabine and to find the best dose~     to give to future patients. The goal of Phase 2 of the study is to learn if this dose can~     help to control AML and/or MDS. The safety will then continue to be studied.~   "
69973|NCT02141464|"~     Ivacaftor is a novel, FDA approved new therapy that addresses Cystic fibrosis transmembrane~     conductance regulator (CFTR) dysfunctions in subjects with Cystic fibrosis (CF) and gating~     mutations.~      The primary aim is to determine the mechanism(s) for weight gain in participants whom~     Ivacaftor treatment was initiated based on clinical indications by CF Care Team. This~     longitudinal study will assess in detail energy expenditure, weight gain, body composition,~     and lung function in 24 subjects ≥6 years old with CF with a gating mutation before~     treatment and after three months treatment with Ivacaftor. All subjects will be seen at the~     Children's Hospital of Philadelphia's Clinical Translational Research Center.~   "
69974|NCT02141451|"~     This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with~     rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT)~     for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases.~     The dose finding phase is a modified version of a phase I trial and the extended phase is a~     modified version of a phase II trial.~   "
69975|NCT02141438|"~     Observational study in the routine clinical practice setting to evaluate the short and long~     term safety profile of Radium-223 in metastatic castration resistant prostate cancer~     patients and to evaluate the risk of developing second primary cancers.~   "
69979|NCT02141386|"~     Cognitive impairment remains a major disability for individuals with multiple sclerosis~     (MS). The primary objective of this study is to evaluate the efficacy for treating~     MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive~     cognitive remediation treatment (PACR) compared to a computer-based control. This novel~     cognitive remediation approach has led to striking improvements in cognitive functioning in~     other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never~     been applied to individuals with MS. The investigators will enroll 136 MS participants who~     will be randomized in a 2:1 pattern to complete either the treatment or control condition~     for 60 hours across a 12-week treatment period. Both the treatment and control conditions~     will be accessed remotely by the subjects from a study-provided laptop computer. Study~     outcomes will include program compliance, performance on study tasks and neuropsychological~     measures, quality of life and functional status. Given the success of this program with~     other disorders and strong preliminary data from our feasibility study, the investigators~     believe PACR is an exciting untapped opportunity to improve cognition in individuals with~     MS.~   "
69980|NCT02141373|"~     Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary~     dissection in breast cancer patients.~   "
69981|NCT02141360|"~     This hypothesis-generating feasibility study is being conducted to determine potential~     associations between a broad range of clinical neurological symptoms and MR images, data,~     and clinical findings involved in mild traumatic brain injury (mTBI). These associations~     will be examined over the acute and sub-acute period (approximately 3 months) following~     injury to provide information useful for optimization of MR pulse sequences for mTBI~     applications.~      The intent of this study is to broadly generate a range of potential mTBI biomarkers~     detectable using investigational MR pulse sequence technologies. Feasibility data attained~     in this study may be used for engineering program decision-making and in support of future~     scientific assessment, engineering development, published research databases or registries~     mTBI data and images, and other purposes determined by the Sponsor. The results of this~     study are not intended for use in regulatory submissions.~      Subjects will be examined on commercially available MR scanners using investigational or~     standard of care MR coils and a series of investigational Application Packs containing a~     predetermined set of MR pulse sequences optimized by GEHC.~   "
69982|NCT02141347|"~     A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and~     Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab~     in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when~     given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese~     Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma~   "
69983|NCT02141321|"~     The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1~     synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in~     patients delivered before only by cesarean section.~   "
69984|NCT02141308|"~     This study will evaluate the total blood flow in the retina and choroid (structures in the~     back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography.~     Angiography is mapping of the blood vessels.~      The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare~     diseases in these structures causes a change in blood flow compared to healthy eyes and 2.)~     find out if areas of changed blood flow line up with areas of damage that appear on~     conventional testing.~   "
69985|NCT02141295|"~     This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab~     to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic~     acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in~     participants with previously untreated metastatic colorectal cancer (mCRC). The study~     consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized,~     parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants~     will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm~     the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will~     be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 +~     bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each~     14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either~     bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic~     acid plus either vanucizumab or bevacizumab for up to 24 months or until disease~     progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever~     occurs first.~   "
69986|NCT02141282|"~     This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy~     and safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after~     B-cell receptor signaling pathway inhibitors (BCR PI) treatment.~   "
69987|NCT02141269|"~     A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with~     limited data available comparing the effectiveness of this device as a screening tool when~     compared to traditional transthoracic echocardiography (TTE).~      The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in~     detecting cardiac pathology in a both an inpatient and outpatient clinical setting as~     compared to a comprehensive TTE evaluation.~   "
69988|NCT02141256|"~     The objective of this study is to investigate whether a protein-enriched daily menu is~     acceptable and effective in increasing protein intake in elderly in a residential care home~     up to an intake of 1,2 gram/ kg body weight per day.~      The investigators hypothesise that when elderly eat 2 slices of bread, 1 portion of juice~     and 1 portion of soup each day, the protein intake can be increased by at least 20~     grams/day. On average this can lead to an intake of 1,2 gram/ kg body weight per day.~   "
69989|NCT02141243|"~     We are proposing to conduct a randomized, controlled trial of newborns in the maternal~     infant care areas at Tampa General Hospital. Participants who are determined eligible for~     the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV~     maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B.~     Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure~     for intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1~     and a sham procedure for intervention #2. Newborns that continue to have difficulty with~     breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and~     breastfeeding will be monitored afterwards.~   "
69990|NCT02141230|"~     Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey~     1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli®~     (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large~     proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the~     European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The~     proportion of respondents overall who reported possible contraindications to Alli® use was~     relatively low. The following changes to the pack labeling were agreed and have been~     implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28~     or above was added to the front of the pack; (2) wording of the BMI statement on the back of~     the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the~     statement that Alli® is not for use by those under 18 years of age was modified for clarity.~     In addition, a pharmacy reminder card was made available to retail pharmacists to improve~     awareness of the prescribing information for Alli®. The survey will assess whether~     compliance with the authorized indication and contraindications among purchasers of Alli®~     has been improved after one year of marketing the revised pack labeling.~   "
69991|NCT02141217|"~     In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of~     odontogenic infection. Therefore, this study is designed to generate data to support its use~     by demonstrating efficacy, safety and tolerability in comparison with clindamycin in~     subjects with acute odontogenic infections with or without abscess. This will be a two-arm,~     parallel, comparative, observer blind, randomised study to assess efficacy, safety and~     tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin~     (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or~     without abscess. The study will be performed in adult subjects both male and female ≥18~     years of age who present with acute odontogenic infections. A total of 472 subjects will be~     randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of~     the study will be at least 5 days or maximum 7 days depending upon the treatment response.~     Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the~     treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show~     treatment response on Day 5, assessments will be performed on Day 7.~   "
69992|NCT02141204|"~     The purpose of this study is to evaluate and compare immunogenicity, reactogenicity and~     safety of two formulations (liquid vs. lyophilised) of GSK Biologicals' HRV vaccine when~     administered as two doses in healthy infants aged ≥ 6 weeks.~   "
69993|NCT02141191|"~     The primary objective of this study is to determine whether a single overnight, eight-hour~     administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary~     Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects~     with cystic fibrosis, as compared to no treatment. This study will be conducted at the~     University of Pittsburgh Medical Center.~   "
69994|NCT02141178|"~     Carpal tunnel syndrome is one of the most common surgeries performed per year in the United~     States, accounting for over 600,000 surgeries. The procedure is commonly performed under~     light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been~     used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a~     liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72~     hours post-operatively. By decreasing post-operative pain through the use of a long-acting~     local anesthetic, the use of narcotic pain medications may be decreased and patient~     satisfaction scores may increase.~      The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine~     with respect to post-operative pain control, narcotic usage, and patient satisfaction after~     carpal tunnel release.~   "
69995|NCT02141165|"~     Primary objectives: To determine the efficacy and cost-effectiveness of a management program~     for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or~     specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be~     made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the~     specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an~     intermediate-high suspicion of OSAS will be included, taking as primary variables the~     Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.~      Secondary objectives: efficacy of the two SAHS management programs according to the~     following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and~     analogical wellbeing scale, b) adherence to and compliance with the treatment.~   "
69996|NCT02141152|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted~     therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS,~     duration of response and overall survival) of patients with advanced cancer, the~     investigators are going to take a fresh tissue of patients and process molecular profiling~     and receive molecular profile directed treatments.~   "
69997|NCT02141139|"~     It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent~     the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory~     drug) has been suggested.However, there was no consistent results. surgery is main cause of~     inflammation for cancer patients. Therefore, we want to know the association between~     prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.~   "
69998|NCT02141126|"~     The primary aim of this research is to evaluate changes in lower limb strength and physical~     function following six weeks of resistance training and routine physiotherapy versus a~     control group of routine physiotherapy only in an older inpatient population.~   "
69999|NCT02141113|"~     This is considered an investigator-initiated clinical research trial, which means that your~     study doctor is researching a particular medication (in this case a medication that is~     currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication~     is guanfacine hydrochloride.~      The hypothesis is that this medication could be used in adults with Attention~     Deficit/Hyperactivity Disorder who have not received satisfactory results with their current~     stimulant ADHD medication. The study drug is investigational for use in adults.~     Investigational means it has not been approved by the U.S. Food and Drug Administration~     (FDA) for use in adults.~   "
70000|NCT02141100|"~     The purpose of this phase 1-2 study is to explore the applicability of supplementing~     standard methotrexate/6-mercaptopurine (MTX/6MP) maintenance therapy of children with~     non-Hodgkin lymphoma with 6-thioguanine (6TG).~      The investigators hypothesize that addition of 6TG to 6MP-based maintenance therapy of~     patients with high TPMT activity will mimic the more favourable thiopurine metabolism of~     patients with low TPMT activity and ultimately reduce relapse rates.~   "
70001|NCT02141087|"~     This is an open label multi-center program to allow patients in the US with IPF access to~     treatment with pirfenidone.~   "
70002|NCT02141074|"~     This trial is conducted globally. The aim of the trial is to investigate the safety and~     efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.~   "
70003|NCT02141061|"~     This study is a double-blind crossover study in female healthy volunteers to compare the~     pharmacokinetics and safety of a single dose each of two different formulations of Proellex~     for oral administration. Each formulation will be designated as either Treatment A or~     Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to~     receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day~     washout period subjects will receive the alternative treatment. On the day of each treatment~     subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment~     at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after~     administration of study drug.~   "
70004|NCT02141048|"~     The purpose of this study is to determine whether the Parent Centre's Positive Parenting~     Skills Training (PPST), a parenting programme being delivered in South Africa, is effective~     in improving parenting, and child behaviour related outcomes.~   "
70005|NCT02141035|"~     Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe~     carpal tunnel syndrome.~      Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In~     severe cases, nerve regeneration and functional recovery are incomplete even with surgery.~     The goal of this pilot project is to test a potentially promising medication,~     acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled~     study design. Along with surgery, those in the treatment group will also receive ALCAR while~     the other half in the control group will be given placebo. To gauge the effects of ALCAR, we~     will compare motor and sensory nerve growth as well as functional outcomes. The data from~     this study will provide crucial information when designing a full scale clinical trial. If~     successful, this will represent an important first step in finding a novel treatment to~     improve functional outcomes in patients with severe CTS.~   "
70006|NCT02141022|"~     This study is investigating the efficacy of computer-based cognitive exercises as a means of~     cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease~     modifying pharmacotherapy Gileyna.~   "
70007|NCT02141009|"~     Community acquired pneumonia (CAP) is an important health problem with significant~     morbidity, mortality and cost. The most identified pathogen in CAP is Streptococcus~     pneumoniae. This was also the causative agent most frequently found in the Ovidius and~     Triple-P study, two consecutive clinical trials initiated by the St. Antonius Hospital~     Nieuwegein. Diagnosis of pneumococcal pneumonia can be based on positive blood cultures,~     sputum cultures, urine antigen testing or a serotype specific antibody response. When~     pneumococcal pneumonia is diagnosed by a positive culture, a matching serotype specific~     antibody response is expected. However not all patients in the Ovidius and Triple-P study~     with a culture proven pneumococcal pneumonia showed an antibody response against the~     infecting pneumococcal serotype. Patients who survived pneumococcal pneumonia are considered~     as a high-risk population for pneumococcal disease in the future. Possibly these patients~     have an impaired immune response against S. pneumoniae. In this study, pneumococcal~     vaccination of patients with S. pneumoniae CAP in the past enables investigating their~     immune response after vaccination compared to patients with CAP due another causative agent.~     Furthermore this study provides information to determine if there is a difference in~     vaccination response between pneumococcal pneumonia patients who had a culture matching~     serotype specific antibody response and between pneumococcal pneumonia patients who failed~     to elicit this response previously. Possibly these latter patients had a temporarily low~     titre due to the infection but another explanation is that there might be a structurally~     impaired immune response against S. pneumoniae or certain serotypes.~   "
70008|NCT02140996|"~     In epithelial cancer, MUC-1(mucin-1) overexpression is thought to disrupt E-cadherin~     function, leading to anchorage-independent tumor cell growth and metastases. Elevated levels~     of MUC-1 expression have been found in patients with epithelial cancers of breast, ovarian,~     colon and lung. Furthermore, overexpression of MUC-1 is independently correlated with~     adverse clinical phenotypes, metastases and resistance to chemotherapy. In animal models,~     suppressing the expression of MUC-1 reduces the rates of growth and metastasis and increases~     the sensitivity of the cancer to chemotherapy-induced cell death.~      In this study, an adenoviral Ad-sig-hMUC-1/ecdCD40L vector encoding a fusion protein in~     which the hMUC-1 epithelial antigen is attached to the CD40L (CD40 ligand). The preclinical~     results have also shown that two subcutaneous Ad-sig-hMUC-1/ecdCD40L vector injections can~     induce immunity through activation of dendritic cells and promotion of antigen specific B~     cells or antigen specific CD8 effector T cells which suppresses the growth of hMUC-1 tumor~     cells in 100% of the vaccinated mice without Interleukin (IL) 2 stimulation being required,~     this suggests that the Ad-sig-hMUC-1/ecdCD40L vector prime-hMUC-1/ecdCD40L protein boost has~     the potential to be an effective vaccine in epithelial tumors. Therefore, the safety and~     tolerability of the Ad-sig-hMUC-1/ecdCD40L vector vaccine will be tested in this phase I~     non-randomized open label dose escalation trial for men or women with metastatic or~     recurrent epithelial cancers of the lung, breast, ovary, prostate and colon.~   "
70009|NCT02140983|"~     The purpose of this study is to evaluate the effects of liraglutide on the memory and~     attention of people with insulin resistance. Liraglutide is a medication that makes the body~     more sensitive to insulin, and therefore may allow it to manage sugar more effectively.~      The investigators are looking specifically at a region of the brain that is associated with~     memory and attention, called the hippocampus, in order to see whether treatment this~     treatment will change performance on memory and attention tasks. The investigators are also~     taking an MRI of the brain to see whether there are changes to the size and shape of the~     hippocampus after treatment.~      All subjects in this study will be 50-70 years old and have pre- diabetes. Half of all~     subjects will have a family history of dementia, while the other half will not.~   "
70010|NCT02140970|"~     This study plans to learn more about whether ibuprofen can reduce pain after removal of a~     ureteral stent more than a placebo. Some patients experience pain after removal of a~     ureteral stent. The investigators plan to learn how often this occurs and whether it can be~     prevented.~      The investigators hypothesize that children who have a temporary, indwelling ureteral stent~     will experience a significantly less post-operative pain if given a non-steroidal~     anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo.~     The investigators hypothesize that the incidence of severe post-stent removal pain is~     similar to an adult population.~   "
70011|NCT02140957|"~     Observational studies support an association between bottle feeding beyond 15 to 18 months~     of age and lower socioeconomic status, excessive milk intake, dental caries, iron~     deficiency, behavioral issues and obesity. Yet many parents, particularly those from low~     socioeconomic households, choose to feed their children by bottle much beyond this age.~     Recognizing the need for further educational interventions for bottle feeding, the TARGet~     Kids! Research Collaboration recently developed a 5-minute bottle weaning educational~     intervention for the 9 month well-child visit. We undertook a pragmatic randomized~     controlled trial to evaluate its effectiveness involving 251 children recruited through~     TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational~     intervention for parents of 9-month-old children could reduce bottle use and iron depletion~     at 2 years of age.~   "
70012|NCT02140944|"~     IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older,~     who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer,~     hematopoietic disease, or other underlying disease.~   "
70013|NCT02140931|"~     A randomized, double-blind placebo controlled study to determine the safety and efficacy of~     Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in~     patients treated with standard of care and with no surgical revascularization option. It is~     assumed that the ACP-treated group will have a lower amputation and death rate as compared~     to the placebo group. Other hemodynamic, imaging and clinical parameters will also be~     compared between the two groups. Quality of life assessments will also be performed.~   "
70014|NCT02140918|"~     Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in~     survival in septic shock patients with relative adrenal insufficiency. However, the utility~     of low doses of steroids and in particular of mineralocorticoids in septic shock is still~     discussed.~      The purpose of the investigators study is to investigate the effects of 3 increasing doses~     of fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best~     pressor response to phenylephrine in healthy volunteers, and simultaneously assess their~     respective hemodynamic and biological effects.~   "
70015|NCT02140905|"~     The study has two objectives based on the intended-use measurements and populations~     described above. The first objective is to show that relative changes in impedance as~     measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed~     during dialysis (ΔF) for subjects with ESRD and possibly Heart Failure.~      The second objective is to demonstrate correlation between ΔSFI and relative changes in~     impedance (ΔZ) as measured by the reference device.~   "
70016|NCT02140892|"~     One of the main goals of the respiratory physical therapy is to help people who are~     suffering from accumulating of secretions in their airways and lungs.~      Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute~     Exacerbation of their medical condition.~      Those patients usually get only the standard medical care during the acute phase and don't~     get respiratory physical therapy treatment.~      The study's main aim is to investigate if respiratory physical therapy treatment in addition~     to standard medical care during the acute phase, can improve the respiratory and medical~     condition and reduce hospitalization stay.~      In order to do so we will compare three groups of COPD patients during acute exacerbation;~     two groups will get one out of two respiratory physical therapy techniques; manually or~     Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the~     third group will get standard medical care alone.~   "
70017|NCT02140879|"~     This research study will examine how diet during pregnancy can benefit pregnancy and~     pregnancy outcome, such as your baby's weight. More specifically, the investigators will~     study the effects of two different food oils/fats that are commonly consumed to determine if~     one is more effective in limiting maternal inflammation during pregnancy. You are being~     asked to take part in this study because it will help us update and make the best dietary~     recommendations for pregnant women and women of child bearing ages.~   "
70018|NCT02140866|"~     The study examines whether hand exercise therapy as an add on to a compensatory intervention~     program focused on joint protection, assistive devices and alternative methods of doing will~     improve the performance of ADL tasks requiring hand function in patients with rheumatoid~     arthritis (RA).~   "
70019|NCT02140853|"~     Objective~        1. To evaluate the impact of MDR pathogen on prognosis and therapy cost;~        2. To compare the efficacy of different antibiotics in treatment of infection caused by~          MDR pathogens;~        3. To evaluate the risk factors of MDR pathogens infection;~        4. To evaluate the distribution and characteristics of MDR pathogens;~        5. To investigate the proportion of MDR isolates to construct systematic database.~   "
70020|NCT02140840|"~     The purpose of this study is to evaluate the overall response rate of Trametinib when~     administered orally to patients with relapsed or refractory multiple myeloma~   "
70053|NCT02140411|"~     Lucentis® (ranibizumab) is a humanized anti-vascular endothelial growth factor (VEGF)~     monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the~     treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular~     degeneration.~      Currently, there is limited epidemiologic information in Chile regarding the incidence of~     DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the~     efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical~     and functional improvement following this treatment and to increase the local experience~     regarding the use of anti-VEGF in the treatment of diabetic macular edema.~   "
70054|NCT02140398|"~     Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with~     polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation~     induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers~     supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost~     fertility in these women.~   "
70021|NCT02140827|"~     Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of~     colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel~     cleansing reduces the cecal intubation rate, and the polyp detection rate (PDR). It also~     increases costs, mostly due to repeated procedures. The quality of bowel cleansing has~     remained suboptimal even though numerous different products and regimens have been tested~     and compared in no fewer than six meta-analyses. Therefore, a completely different approach~     to improve bowel cleansing is welcome.~      Here the investigators assume that instant messaging program (Wechat) delivery the detail~     and FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the~     quality of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports~     over 400 million users, nearly half of the mobile subscribers population in China; 2. Wechat~     provided a real time communications including voice messages, pictures and text exchange~     timely; 3.Compare with telephone, Wechat is economical of both time and money; 4. Compare~     with bowel preparation instructional software and litera or cartoon educational booklet,~     Wechat is more interactive and responsive.~   "
70022|NCT02140814|"~     The goal of this pilot study is to evaluate the feasibility of administering niacinamide to~     patients with autosomal dominant polycystic kidney disease, to develop methods to assess the~     biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical~     effect on kidney cyst growth and kidney function.~   "
70023|NCT02140801|"~     A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI)~     with a native coronary stenosis suitable for DES implantation and OCT imaging are openly~     randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).~   "
70024|NCT02140788|"~     One purpose of this study is to test whether adding metformin will limit some of the~     unwanted effects of clozapine, compared to not adding metformin. Metformin is a medication~     that is approved by the United States Food and Drug Administration (FDA) for the treatment~     of type-2 diabetes. Studies have found that people with type-2 diabetes often lose some~     weight when they take metformin, however the FDA has not approved metformin for weight loss,~     so for this study the use of metformin is investigational. This study will test whether~     metformin can help people with schizophrenia or schizoaffective disorders lose weight.~      Another purpose of this study is to test whether adding fish oil will improve the benefit of~     clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding~     fish oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in~     blood. Some studies have found that adding fish oil reduces psychosis (voices,~     suspiciousness). However the FDA has not approved fish oil for reducing psychosis, so for~     this study the use of fish oil is investigational. This study will test whether fish oil can~     help people with schizophrenia or schizoaffective disorders have less psychosis. Fish oil is~     not an antipsychotic medication.~   "
70025|NCT02140775|"~     The current study is a randomized clinical trial comparing Behavioral Activation counseling~     with supportive counseling for HIV+ participants presenting with clinically significant~     fatigue whose energy has improved with armodafinil, who have the goal of returning to work~     or vocational training but have not done so on their own. A second cohort of HIV+~     participants without significant fatigue at baseline, but who also have the goal of~     returning to work, will also be randomized to either Behavioral Activation counseling or~     supportive counseling. In both cohorts, the primary outcome is level of success regarding an~     employment related goal.~   "
70026|NCT02140762|"~     Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a~     single dose of MenACWY vaccine.~   "
70027|NCT02140749|"~     Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal~     bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore,~     these dietary non-digestible carbohydrates might relieve functional constipation.~      Objective: Study the effect of short-chain fructooligosaccharides on functional~     constipation.~      Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with~     intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4~     weeks.~      Study population: Human subjects with functional constipation according to ROMEIII criteria~     (total n=120; male and female; 18-75 yr).~      Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides,~     (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral~     chews.~      Main study parameters: The primary parameter is the number of complete bowel movements per~     day in subjects with functional constipation according to Rome III criteria. Secondary~     outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms~     (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation~     Quality of Life; PAC-QoL).~   "
70028|NCT02140736|"~     The main aim of this study is to observe correction of the hemoglobin level in the patients~     under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor~     or a lymphoma or a myeloma.~   "
70029|NCT02140723|"~     Background:~      Meta-analyses of large randomized trials proved the superiority of preoperative short course~     radiation and surgery, as compared with surgery alone. Short course radiation results in a~     50% reduction in terms of local relapse in stage II and III rectal cancer patients. Patients~     with complete pathological remission additionally show a significant survival benefit.~     Complete pathological remission (pCR) occurs in 8% after preoperative radiation and in >16%~     if the interval between radiation and surgery is at least 8 weeks.~      It is generally accepted that mutations in the TP53 gene represent a crucial defect in the~     apoptosis pathway. Radiation therapy is suggested to act via induction of apoptosis in~     irradiated cells. Therefore, it is expected that a defect in the TP53 gene has an effect on~     the success of radiation therapy.~      Currently available imaging tools are hardly able to diagnose response to radiation therapy~     correctly, as this does not essentially correlate with tumor size.~      Method:~      Aim of this prospective observation study is to strengthen the hypothesis that the TP53~     genotype is a promising marker to predict response to radiation therapy in rectal cancer~     patients. Consequently, the expected results will justify prospective, randomized~     intervention trials to obtain level of evidence I for the p53 marker hypothesis. Trial~     endpoint is downstaging and pCR rate. Tumor stage and pathological remission will be~     evaluated by MRT and pathohistology and correlated to the TP53 genotype of the diagnostic~     biopsy. Additionally, we will investigate the applicability of novel imaging modalities in~     magnet resonance tomography to monitor response to radiotherapy.~      The objective of this study is~        -  to evaluate the effect of a genetic tumor marker (TP53 genotype) on the response to~          preoperative short course radiation (in terms of downstaging and pCR rate)~        -  to evaluate the applicability of novel magnet resonance tomography imaging modalities~          to monitor response to preoperative short time radiation.~      Conclusion:~      The prospective evaluation of the potential predictive marker TP53 may bring us one-step~     closer to an individualized therapy regimen, which allows the restriction of preoperative~     radiation in rectal cancer to those patients who will benefit.~   "
70795|NCT02130687|"~     In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4)~     inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE)~     inhibition but not angiotensin receptor blockade or calcium channel blockade. The~     investigators further hypothesize that this effect is mediated by substance P.~   "
70030|NCT02140710|"~     Timing of the first and last meconium stool is critical for oral feeding tolerance and~     proper gastrointestinal function. The time until premature infants pass their first meconium~     ranges from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract~     by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and~     delayed food passage Recent data support the concept that complete rapid evacuation of~     meconium plays a key role in feeding tolerance . If duration to full enteral feedings is~     extended, the probability to acquire infections due to intravenous access for parenteral~     nutrition increases and hospital stay of the infant prolongates. Previously two prospective~     trials focusing on the problem of delayed meconium evacuation in preterm with different~     therapeutic pharmacological approaches were published by our group. None of the applied~     therapies appeared to be effective or had a beneficial effect- quite the contrary one agent~     (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking~     for an alternative, non-invasive, holistic solution for the problem of delayed meconium~     excretion. Osteopathic treatment with the emphasis on the relationship of the structural and~     functional integrity of the body and with its variety of therapeutic manual techniques~     seemed to be remedy. Treating the abdomen of premature infants with visceral osteopathic~     techniques might be more effective to mobilize meconium from small bowel and deep parts of~     the colon. Therefore we hypothesized that repeated visceral osteopathic treatment~     accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance~     in this population.~   "
70031|NCT02140697|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related~     death each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract~     as a novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L.~     Leaf Extract supplementation on body weight regulation in humans are lacking.~   "
70032|NCT02140684|"~     This study will compare the absolute and relative effectiveness of managing real-life asthma~     with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO)~     as a marker of underlying airway inflammation to guide appropriate management. As exhaled~     nitric oxide responds rapidly to environmental changes and can act as a marker of underlying~     inflammation it is proposed that incorporating eNO monitoring into routine asthma management~     treatment allows strategies to be more accurately tailored to the patients needs, increasing~     the probability of good asthma control.~   "
70033|NCT02140671|"~     Following on from a 10 year study conducted in Finland this study is designed to test the~     validity and sustainability of an enhanced asthma management model for the UK.~   "
70034|NCT02140658|"~     The purpose of this study is to assess the affect of multiple health education interventions~     for statins medication compliance and clinical prognosis of ischemic stroke patients at 3, 6~     and 12 months.~   "
70035|NCT02140645|"~     The objective of this study is to identify EMR-based clinical covariates and quantify their~     association with the prescribing of each specific type 2 diabetes (T2DM) medication under~     investigation. This will include an assessment of how well these covariates are captured~     through claims data proxies, and their potential to confound comparative research of T2DM~     medications.~   "
70036|NCT02140632|"~     Carpal tunnel syndrome is caused by the compression of median nerve at the wrist where it~     passes through a narrow space called carpal tunnel formed by the wrist bones, ligaments and~     tendons. The common symptoms include numbness and pain over the areas supplied by the median~     nerve namely the thumb, the index finger, the middle finger and the outer part of the ring~     finger. There can be loss of sensation, weakness or muscle atrophy in severe cases. The~     functions of the affected hands may be greatly impaired.~      Carpal tunnel syndrome is very common. It can lead to significant economic impact both to~     the affected individual and the society either by the direct treatment cost and indirectly~     from the working ability loss. Despite the vast burden, there is no consensus regarding its~     treatment so far. Surgery is generally effective and often reserved for severe cases. There~     are many nonsurgical treatment options. Local steroid injection and wrist splinting are~     among the commonest and with more evidence. Local steroid injection into the carpal tunnel~     can reduce the inflammation and swelling. Wrist splinting can maintain the wrist at its~     neutral position where the pressure at the carpal tunnel is the least. However, there are~     only very few studies comparing these two treatments directly.~      Patients complaining of finger numbness who have been confirmed to have carpal tunnel~     syndrome by nerve conduction test are invited to participate in the study. The patients who~     agreed to be recruited are asked about their basic informations and the details of the~     carpal tunnel syndrome symptoms. Their hands will be examined. They are asked to fill in a~     questionnaire specific for assessing the symptom severity and the functional status of~     patients with carpal tunnel syndrome. They will then be assigned to one of the two treatment~     groups randomly and receive the respective treatment. They need to come back for follow-up~     at one month and to fill in the questionnaire again.~      The study hypothesis is local steroid injection is more effective than wrist splinting in~     treating carpal tunnel syndrome.~   "
70037|NCT02140619|"~     The study aimed to demonstrate the relationship between secondary prevention medication~     compliance and clinical prognosis of ischemic stroke patients at 3,6,12 months~   "
70038|NCT02140606|"~     To investigate safety, tolerability of cafusertib combination with low dose cytarabine~     (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for~     conventional or intensive treatment. The dose of cafusertib will be escalated to determine~     the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in~     combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics~     and preliminary efficacy of cafusertib will be observed in AML patients. To determine the~     recommended dosage regimen for phase II.~   "
70039|NCT02140593|"~     The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma~     between optimal surgical conditions and the risk of postoperative residual blockade.~      The aim of the study is to investigate if intense NMB improves surgical conditions during~     operation in patients scheduled for elective open upper abdominal surgery.~   "
70068|NCT02140216|"~     An increasing number of publications have demonstrated that homologous (allogeneic) blood~     transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood~     products cannot solve these problems, despite improved quality of red cells; a recent study~     demonstrated deteriorated outcome of cancer patients with elective colon surgery and~     transfusion of leukocyte depleted allogeneic blood.~   "
70111|NCT02139644|"~     Study drug and placebo will be supplied in Teva multidose dry powder inhaler (MDPI) devices~     and provided for participants to use at home. Participants will perform spirometry at every~     visit. Each participant will be given a diary at each visit for use until the next visit.~     Rescue medication (albuterol/salbutamol) will be dispensed at each visit, if needed, as~     determined by the investigational center personnel.~   "
70807|NCT02130531|"~     The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and~     pharmacodynamic parameters in subjects with geographic atrophy associated with dry~     age-related macular degeneration.~   "
70040|NCT02140580|"~     Trial question: Does administration of exogenous surfactant using a minimally-invasive~     technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous~     positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via~     a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration~     of mechanical respiratory support, and a higher incidence of survival without~     bronchopulmonary dysplasia. Trial design: Multicentre, randomised, masked, controlled trial~     in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP~     because of respiratory distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants~     randomised to surfactant treatment receive 200 mg/kg of poractant alfa (Curosurf)~     administered under direct laryngoscopy using a surfactant instillation catheter, followed by~     reinstitution of CPAP. Controls continue on CPAP. The intervention is masked from the~     clinical team. Care thereafter is as per usual in both groups, other than the requirement to~     adhere to intubation criteria. The primary outcome is incidence of death or BPD. Secondary~     outcomes include incidence of death, major neonatal morbidities (BPD, intraventricular~     haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising~     enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and~     surfactant therapy; durations of mechanical respiratory support, intubation, CPAP,~     intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and~     hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and~     outcome at 2 years. The sample size is 303/group, allowing detection of a 33% difference in~     the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December~     2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 5 years~     in multiple centres internationally.~   "
70041|NCT02140567|"~     The purpose of this study is to perform a prospective evaluation of the vasovagal syncope~     prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one~     center in the United Kingdom.~   "
70042|NCT02140554|"~     This is a non-randomized, open label, multi-site, single-dose, Phase 1 study in up to 29~     adults with severe sickle cell disease (SCD). The study will evaluate the safety and~     efficacy of the LentiGlobin BB305 Drug Product [consisting of autologous CD34+ hematopoietic~     stem cells (HSC) transduced with LentiGlobin BB305 lentiviral vector encoding the human beta~     A-T87Q-globin gene].~   "
70043|NCT02140541|"~     To explore the relationship between blood eosinophil counts, asthma exacerbations and~     patient asthma control using a large primary care based research database~   "
70044|NCT02140528|"~     This study is a case-control prospective, clinal trial to assess the safety and efficacy of~     the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of~     recent tibial fracture in 40 patients.~   "
70045|NCT02140515|"~     We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two~     protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the~     beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and~     Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in~     diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for~     group B. Finally Assisted Reproductive Technology (ART) results are compared between the two~     groups.~   "
70046|NCT02140502|"~     In this study, the investigators aim to establish the incidence of enteric fluoroquinolone~     resistant bacteria in a contemporary clinical cohort. This incidence will be studied by~     taking a rectal swab sample from all consenting patients coming in for prostate biopsies.~     The information gained from this study will be used to determine whether antibiotic~     prophylactic practices need to be updated in their clinic. The investigators aim to enroll~     200 patients and patient recruitment is estimated to take place between May 2014 and August~     2014. The study is estimated to end in May 2016.~   "
70047|NCT02140489|"~     The purpose of this study is to evaluate the drug-drug interaction between~     amlodipine/losartan and rosuvastatin in healthy male volunteers.~   "
70048|NCT02140476|"~     Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical~     instruments that use electrical powered diathermic energy to seal and transect tissue. These~     devices have shown high efficiency in a wide variety of open and laparoscopic general and~     gynecological surgical procedures.~      The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic~     cutting devices in several studies. However, the efficacy of this instrument and in~     particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in~     thyroid surgery.~      Our primary aim is to verify whether the EnSeal® performance is superior to the standard~     surgical technique for thyroidectomy in a randomized clinical trial on 2 different~     institutions.~   "
70049|NCT02140463|"~     Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the~     monitoring and treatment of cancer. The investigators have developed a differentiated~     sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic~     abnormalities with ultra high-specificity and sensitivity. The investigators assay is able~     to eliminate the error and distortion created by sample-prep and sequencing processes in~     standard NGS(next-generation sequencing ) workflows and produce near-perfect representations~     of all rare variants.~      The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in~     0.1% cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis )~     generates many high-quality false positive variant calls in the range of 0.05-5%, while the~     investigators assay resulted in highly sensitive and completely error-free variant calls~     across the entire panel.~      This work indicates the remarkable potential of using the investigators assay in deep~     analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and~     non-invasively monitor the genetic dimension of cancer throughout the body.~   "
70050|NCT02140450|"~     To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular~     pressure rise after intravitreal injection.~   "
70051|NCT02140437|"~     This research is designed to investigate whether the addition of fulvestrant 500mg to~     anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced~     breast cancer.~   "
70052|NCT02140424|"~     This is an observation study of girls ages 10-16 years with type 1 diabetes and age- and~     race-matched controls. The investigators will be examining blood and urine hormone levels as~     well as measures of bone density including DXA and high-resolution peripheral quantitiative~     computed tomography. The investigators hypothesize that youth with type 1 diabetes will have~     slower bone accrual and impaired bone microarchitectural integrity compared with~     non-diabetic controls. The investigators hypothesize that poor bone accrual will be~     associated with sub-optimal glucose control as well as lower levels of insulin-like growth~     factor 1.~   "
70077|NCT02140086|"~     A randomized, controlled trial to investigate the effects of a buteyko based remedial~     breathing therapy on children with asthma regarding to their symptoms, use of medication and~     lung function tests.~   "
70055|NCT02140385|"~     The purpose of this study is to determine whether leaving a thicker layer -which preserves~     the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases~     the damage to the lymphatic system.~      In order to investigate the effect of leaving a thinner or slightly thicker layer intact~     during a tummy tuck, patients who are already planning to undergo the surgery, and who agree~     to participate, will be randomly assigned to two groups in a manner similar to flipping a~     coin. The first group will have their abdominoplasty performed with a thinner layer of~     abdominal wall left in place while the second group will have the surgery with a slightly~     thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of~     care, and the aesthetic outcomes will not be negatively impacted by either of the options.~      Before and after the surgery, a procedure called lymphoscintigraphy will be performed.~     Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is~     injected and then detected by a special camera. The pictures provided by the~     lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small~     network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will~     help investigators to know what method of performing the tummy tuck leaves the lymphatic~     system most intact.~      In addition, photographs of each patient's abdomen will be taken using a special camera that~     allows investigators to put the photographs in the computer and compile a 3-dimensional~     image. Investigators will be able to look at the volume changes from swelling after the~     surgery using these pictures. Finally, an ultrasound will be used to help identify any~     seromas, or fluid collections, that may form after the surgery.~      The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether~     or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid~     draining lymphatic system and whether or not that effects recovery after the procedure.~   "
70056|NCT02140372|"~     This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour~     later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug~     administration, 2 hours after colchicine administration, and 24 hours after colchicine~     administration via the antecubital vein and evaluated for markers of platelet activity and~     inflammation.~   "
70057|NCT02140359|"~     Housing First programs are promising approaches to transitioning substance using chronically~     homeless adults to affordable housing. However, Housing First programs need to provide~     support to residents to adjust to their changing social environments. The proposed project~     fulfills a critical gap by developing an electronic tool for a social network intervention~     using motivational interviewing techniques as well as results of a pilot test of the tool.~     The hypothesis to be tested is that Housing First residents who are given the intervention~     will be significantly more motivated to change their drinking, drug use, sexual risk~     behaviors, and social networks compared to controls receiving usual care.~   "
70058|NCT02140346|"~     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD). The~     objective of this study is to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.~   "
70059|NCT02140333|"~     The purpose of this study is to determine whether 100mg erlotinib had similar effect~     compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.~   "
70060|NCT02140320|"~     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The objective of this study is to investigate the safety, tolerability and pharmacokinetics~     of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.~   "
70061|NCT02140307|"~     The purpose of the study is to investigate health-promoting and stress-reducing~     psychological, physiological and hormonal effects of a 9-week meditation-based course in~     personal health and to examine potential baseline factors for any such effects. Thus, the~     investigators will investigate the course format (individual course or group-based course)~     as a potential factor the course outcome, and also individual background factors such as~     demographics and genetic variations.~   "
70062|NCT02140294|"~     Patient found to be malnourished after the nutritional evaluation would be randomized in the~     two groups of the study. The control group would receive standard nutritional counseling~     from a trained dietician where as those in the intervention group would be given 120 gm of a~     polymeric nutritional supplement providing around 500 Kcal per day over and above the~     standard nutritional counseling from a trained dietician. Both the groups would receive~     standard medical treatment. The polymeric nutrient supplement would be taken by the patients~     in this arm for a period of 6 months.~   "
70063|NCT02140281|"~     A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of~     Cefadroxil~   "
70064|NCT02140268|"~     A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of~     Oral Midazolam in Healthy Volunteers~   "
70065|NCT02140255|"~     IMPAACT P1115 will explore the effects of early intensive antiretroviral therapy (ART) on~     achieving HIV remission (HIV RNA below the limit of detection of the assay) among~     HIV-infected infants.~   "
70066|NCT02140242|"~     The proposed trial will address two clinically important questions for younger patients with~     newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction~     therapy and the necessity of a second induction cycle in patients with a good response after~     the first induction. In the first part of the trial, patients will be randomly assigned to~     receive either 90 mg/m2 or 60 mg/m2 daunorubicin in the first induction cycle in addition to~     standard dosed cytarabine. The primary endpoint is the rate of good responders. Assuming a~     superiority of 90 mg/m2, 436 patients will be recruited. In the second part of the trial,~     good responders will be randomized to receive either a second or no further induction cycle.~     Assuming a non-inferiority of the single induction regarding the rate of complete~     remissions, a number of 360 patients will be included in the second part. Secondary outcomes~     will be relapse-free survival, overall survival and minimal residual disease kinetics.~     Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia~     study group over a period of 40 months. The results will be of great clinical relevance:~     First, the study could facilitate the establishment or confirmation of the optimal~     daunorubicin dose. Furthermore, in case of a non-inferiority of single versus double~     induction in good responders, about half of all younger AML patients could be spared a~     second induction cycle, leading to a reduction in treatment-related mortality, fewer days~     spent in hospital and improved quality of life.~   "
70067|NCT02140229|"~     Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks~     to a large choice of therapies, early treatment and tight control (30% relapse).~      Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may~     improve the prognosis of RA in remission by increasing the duration of sustained remission~     and by preventing radiographic structural progression.~      The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained~     clinical remission.~   "
70069|NCT02140203|"~     Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing~     central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of~     MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has~     been a useful tool in prognosing the development of cardiovascular disease and diabetes~     mellitus. Importantly, interventions applied at the pre-pathologic stage with MetS would be~     of great clinical and health significance in achieving better preventive and therapeutic~     outcomes. Yoga, a mind-body exercise, has been suggested to have beneficial effects on~     dyslipidemia, hypertension and diabetes. A pilot study has demonstrated the trends in the~     improvement of metabolic parameters in middle-aged adults with MetS but the findings are~     inconclusive because of the small sample size and brief yoga follow-up period (i.e.,~     2-month). In addition to the needs of a better designed randomized controlled trial in~     studying the beneficial effect of yoga in controlling MetS in middle-aged individuals, the~     investigation on yoga and MetS in elderly population has been lacking. This is important as~     the potential use of yoga as lifestyle modification in elderly individuals with MetS will~     result in significant reduction of the prevalence of cardiovascular disease and diabetes.~     Thus, this study aims to examine the efficacy of yoga exercise in improving metabolic~     abnormalities in middle-aged and older adults with MetS. In addition to elderly, middle-aged~     adults are included in the present investigation because of the idea that cardiovascular~     diseases and diabetes with aging can be mostly prevented by intervention at the middle-age.~     A randomized controlled trial with repeated measure design will be conducted to examine the~     effect of 1-year regular yoga training on the MetS parameters in middle-aged and older~     individuals who are 30-60 and 60-80 years of age, respectively. Primary outcome measures~     include waist circumference, systolic/diastolic blood pressure, blood glucose, triglyceride,~     and lipid cholesterol profile whereas secondary outcome measures include self-reported~     stress and depression levels. This study is anticipated to provide valuable information in~     exploring the therapeutic role of yoga in managing MetS. As yoga exercise is an economical~     regimen which can be easily and readily applied to large scale of target population, it is~     of hope to be practically useful to relieve the burden on cardiovascular disease and~     diabetes by introducing yoga lifestyle to the management of MetS.~   "
70070|NCT02140177|"~     Background:~      - Suicide is the 10th leading cause of death for U.S. adults. Medically ill people are at an~     increased risk of suicide. Most people who have killed themselves went to a healthcare~     provider within 3 months of their death. More and more, hospitals are being asked to assess~     people for signs of suicide risk so that they can get the help they need. If nurses and~     doctors can find out who is at risk they can make sure these people get help in the~     hospital.~      The asQ em (Ask Suicide-Screening Questions to Everyone in Medical Settings) is a brief~     questionnaire. It was created to detect suicidal thoughts and behaviors in hospitalized~     people. Researchers would like to further develop this tool and figure out which are the~     best questions to ask patients.~      Objective:~      - To determine the best questions for healthcare providers to ask people with medical~     illnesses to see if they are having suicidal thoughts or planning to hurt themselves.~      Eligibility:~      - NIH Clinical Center patients over age 18.~      Design:~        -  Participants will be asked questions about how they have been feeling in the past few~          weeks. They will be asked questions about depression, anxiety, and suicidal thoughts~          and behaviors. They also will be asked some background questions.~        -  It will take approximately 15 to 30 minutes to answer the questions.~   "
70071|NCT02140164|"~     Background:~      - Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central~     retina. This can cause decreased central vision. The cause of macular edema is unknown, but~     may involve inflammation. The drug minocycline might help prevent inflammation and therefore~     might help treat macular edema and improve central visual function .~      Objectives:~      - To see if minocycline helps people with RP and macular edema.~      Eligibility:~      - People 12 years and older with RP who have macular edema in at least on eye.~      Design:~        -  Participants will be screened with medical and eye disease history. They will have an~          eye exam and blood tests. One eye with macular edema will be the study eye. If both~          eyes are affected, one will be designated the study eye.~        -  Participants will visit the clinic at least 9 times over at least 14 months. The first~          3 study visits will be monthly, then every 2 months.~        -  Participants will start taking minocycline after visit 3. They will take 1 pill twice~          daily for at least 1 year.~        -  Participants will keep a medicine diary and bring it to each visit with their pill~          bottle and unused pills.~      At each study visit, participants will have some or all of the following tests:~        -  eye and thyroid exams~        -  blood and pregnancy tests~        -  microperimetry: participants will press a button when they see a light on a computer~          screen~        -  visual field measurement: participants will look at spots on a white screen to test~          side vision~        -  electroretinogram: A person will be dark adapted by sitting in the dark for 30 minutes.~          After the placement of numbing eye drops, special contact lenses will be placed . The~          participant will watch flashing lights and recordings will be made.~   "
70072|NCT02140151|"~     This study will determine whether quarterly injections of Ranibizumab may prevent eyes with~     dry age-related macular degeneration from progressing to wet age-related macular~     degeneration (AMD).~   "
70073|NCT02140138|"~     The purpose of this study is to evaluate the induction of immune responses against CV9104~     administered by conventional intradermal injection or with a needle-free intradermal~     injection device and to assess the safety and tolerability of CV9104 administered by~     conventional intradermal injection versus injection with a needle-free intradermal injection~     device versus no injection.~   "
70074|NCT02140125|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The~     pharmacodynamics of ASP2408 is also being evaluated.~   "
70075|NCT02140112|"~     This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric~     patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment~     and 16 weeks of placebo.~   "
70076|NCT02140099|"~     Adolescent risk behaviours, such as violence and substance use, are prevalent public health~     concerns in Canada. Further, these behaviours often co-occur, and are associated with poor~     mental health. However, the majority of prevention programs focus on preventing single~     issues and do not consider mental health, and also neglect the importance of relationships~     when promoting positive youth development. To address this gap, the Centre for Addiction and~     Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy~     Relationships Plus Program, a small group program focused on the promotion of positive~     mental health and the reduction of violence and substance use, via the development of~     improved communication, interpersonal and help-seeking skills. The purpose of this study is~     to evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized~     controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and~     process evaluation tools.~      The primary study hypothesis is that participation in the Fourth R Healthy Relationships~     Plus program will be associated with positive growth in treatment participants'~     psychological well-being from pre-test to 12-month follow-up, as compared to control~     participants. In secondary analyses, the study will explore if treatment participants report~     less substance use, peer violence, bullying and dating violence at 12-month follow-up than~     control participants. Since certain person-level (e.g., sex, personality, executive~     functioning) and program-level (e.g., implementation quality) variables may moderate~     treatment-outcome relationships, these associations will also be explored. The final~     hypothesis is that treatment participants will report better attitudes, knowledge and~     assertive communication at post-test compared to control participants, and that these~     improvements will mediate the association between program participation and 12-month~     outcomes.~   "
70078|NCT02140073|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     omeprazole in combination with domperidone in GERD treatment for subsequent efficient~     pharmacotherapy of GERD.~      Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone~     regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of~     treatment To compare the efficacy of omeprazole in combination with domperidone regarding~     change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To~     assess the efficacy of omeprazole in combination with domperidone regarding change of~     incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare~     the efficacy of omeprazole in combination with domperidone regarding change of incidence and~     severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the~     efficiency and advantages of one GERD therapy considering efficacy, safety, and individual~     variance of patients' reactions~   "
70079|NCT02140060|"~     The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination~     (Trav/Brinz) administered twice daily as compared to each of its marketed components~     (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z®~     plus AZOPT® in lowering intraocular pressure (IOP).~   "
70080|NCT02140047|"~     The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered~     with DPT-IPV using ActHIB® as a control in healthy infants.~   "
70081|NCT02140034|"~     This study is carried out to determine the merit and reliability of extensive intraoperative~     peritoneal lavage as a preventive strategy~      Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk~     of peritoneal recurrence~   "
70082|NCT02140021|"~     The goal of this clinical research study is to learn how often high-grade dysplasia or~     invasive squamous cell carcinoma of the anus occurs in women with high-grade dysplasia~     invasive squamous cell carcinoma, invasive adenocarcinoma, or AIS of the cervix, vagina, or~     vulva.~   "
70083|NCT02140008|"~     Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice.~     The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway~     devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable~     cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing~     the potential for postoperative complications such as sore throat. The overall structure of~     the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff.~     The aim of this randomized trial was to compare the clinical performance of the i-gel and~     the air-Q SP.~   "
70084|NCT02139995|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 6~10g/dL is based on the judgment from doctors. Index of~     transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary~     and important in clinical practice.~      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen~     consumption, the investigators hypothesize that index of transfusion trigger for patients~     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including~     infusion rate of inotropic drugs for maintaining normal cardiac output, fraction of inspired~     oxygen, core temperature, and torlerance to anemia. To verify this hypothesis, the~     investigators present West China Transfusion Score for Critically-ill Patients(WCTS-CP) for~     the trigger of transfusion according to the patient's history and monitoring parameters, and~     the investigators design a randomized controlled clinical trial to test this score.~   "
70085|NCT02139982|"~     Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However,~     regional hemodynamic changes of radial and ulnar artery after specific nerve block of~     brachial plexus remains unclear. The aim of the study is to assess the effect of specific~     nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for~     further research in patient undergoing microvascular surgery.~      Phase 2 There is no literature about dose-finding studies of sympathetic block after~     brachial plexus block. Little is known regarding the relationship between concentration of~     local anaesthetic and vasodilation of upper extremity. The aim of this randomized,~     double-blind, prospective dose-response study is to determine the ED50 and ED95 of~     ropivacaine in sympathetic block of upper extremity after supraclavicular block~   "
70086|NCT02139969|"~     The purpose of this study is to gain information on the safety, efficacy, and quality of~     life in subjects who have had the GreenLight XPS procedure.~   "
70087|NCT02139956|"~     Continent women have an intact internal urethral sphincter that extends from the bladder~     neck down to the perineal membrane. The internal urethral sphincter is a strong collagen~     muscle tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be~     detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure.~     Three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive~     and specific for the diagnosis of stress urinary incontinence.~   "
70088|NCT02139943|"~     The purpose of this study is to assess the effects of administration of canagliflozin 100 mg~     and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of~     Type 1 Diabetes Mellitus (T1DM).~   "
70089|NCT02139930|"~     The main goal of this project is to compare two different approaches to reducing levels of~     nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to~     non-addictive levels or a gradual reduction in nicotine content in cigarettes to~     non-addictive levels. These two approaches will then be contrasted to a group that continues~     to smoke cigarettes with nicotine content similar to conventional cigarettes.~   "
70090|NCT02139917|"~     Primary aim:~        1. To compare the effects of customary care and an interventional Home-based Palliative~          Renal Program (HBPRP) for ESRF patients~        2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for~          ESRF patients~           Secondary aim:~        3. To explore the lived experiences of patients with ESRF. Hypothesis The transitional~          renal palliative care model is associated with decreased in unscheduled hospital~          readmission, reduce length of stay as well as improved quality of life for patients~          with end-stage renal failure.~   "
70091|NCT02139904|"~     This study is for patients with malignant mesothelioma of the lung lining (called pleura)~     who have had previous chemotherapy with a platinum-based regimen whose disease has~     progressed. Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug~     resistant, and incurable disease that is increasing in incidence in the UK and worldwide.~     All patients with MPM will relapse following first line chemotherapy and at present, there~     is no standard treatment available for patients in the second line setting. The vinca~     alkaloid chemotherapy drug vinorelbine has shown promising activity in a single arm UK~     trial. However to date, there has been no randomised evaluation of vinorelbine in~     mesothelioma in the second line setting. In addition, there have been no trials which have~     looked at underlying molecular changes in mesothelioma which may predict vinorelbine~     efficacy; This might allow vinorelbine to be used in patients only where there is a chance~     of benefit. Studies suggest that vinorelbine requires a gene called BRCA1 (shown to be~     absent in 38% of mesothelioma cases) in order to induce cell death in mesothelioma. The VIM~     trial aims to establish whether vinorelbine in patients with MPM helps them live longer and~     whether the BRCA1 gene is helpful in selecting patients most likely to benefit from~     treatment.~      Patients will be randomised (1:2) to receive either active symptom control (ASC) (which is~     all supportive care deemed necessary for pain management excluding disease modifying~     treatment) or ASC with vinorelbine. Patients will continue vinorelbine treatment until~     evidence of disease progression (or unacceptable toxicity to the drug or patient~     withdrawal). If vinorelbine activity is demonstrated, we will use the results from this~     trial to inform the design of a future phase III trial.~   "
70092|NCT02139891|"~     This study will examine the additional clinical benefit conferred by multipoint pacing (MPP)~     compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON~     vs. OFF and followed for a total of 6 months. This includes two crossover periods for each~     pacing modality (MPP on vs. off).~   "
70093|NCT02139878|"~     Researchers at the University of Prince Edward Island want to learn about the health effects~     of wild blueberry juice.~   "
70094|NCT02139865|"~     When practicing weightlifting regularly the body makes new proteins within the muscle.~      These new proteins can increase the size of the cells within the muscle to make them larger,~     a process called hypertrophy. The common convention surrounding gains in skeletal muscle~     size and strength is that heavy weights are needed. In contrast, lifting lighter weights are~     thought to be required to induce muscular endurance and not to promote growth. However, it~     has previously been shown in untrained men that lifting lighter weights results in similar~     gains in muscle mass and strength as lifting heavier weights. The purpose of this study is~     to examine how performing resistance training of different intensities (light or heavy~     weights) affects the degree of muscle growth and strength gain in individuals who are~     already resistance training.~      This information will be valuable when designing exercise protocols for increasing muscle~     size and strength at all ages, or in individuals returning from injury, as a way to~     stimulate muscle growth and promote strength gains without the need to lift heavy weights.~   "
70095|NCT02139852|"~     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate~     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy~     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid~     for weight loss supplements. Of particular interest are the recent findings that free-fatty~     acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical~     cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were~     unaffected, suggesting some of the negative consequences of other stimulants may be avoided.~     At present, however, more in depth investigations of the effects on endothelial function,~     vascular autonomic tone and inflammation are lacking.~      The investigators seek to understand the effect of 3 months capsaicinoid ingestion on~     alterations in body composition, traditional cardiovascular risk factors and cardiovascular~     function~      Hypotheses:~      1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will~     result in moderate (but clinically meaningful) alterations in body composition manifested as~     a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will~     brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this~     could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone.~     However, previous research suggests that these alterations will not be manifested in~     autonomic nervous tone assessed by changes in heart rate variability.~   "
70096|NCT02139839|"~     The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14~     delivered via capsules to the vagina of post-menopausal women over a three day course of~     treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis~     of microbial ecology, human microarrays and multiplex immunological assessments are included~     to characterize potential effects.~   "
70097|NCT02139826|"~     The purpose of this study is to compare the absorption and blood levels of IX-01 when given~     as a capsule compared to liquid form, and how food affects the absorption in healthy men.~   "
70098|NCT02139813|"~     Several prospective trials and metaanalysis have demonstrated the superiority of bariatric~     surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure~     has been practiced for more than 30 years, and is the procedure of choice for morbidly obese~     with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a~     technically demanding procedure with a learning curve of more than 75 cases. The~     complication rate is around 10% in expert centers.~      More recently another procedure has been described which seems as efficient on weight loss~     and co-morbidities as the RYGBP, with the advantage of being less technically difficult and~     less morbid, especially for multi-complicated obese and/or the super obese. It consists of a~     unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop.~     However, this procedure could be at risk of biliary reflux and anastomotic ulcers with~     dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass~     (OLB) has only been developed by a few teams and remains a controversial subject,~     particularly as only one monocentric randomized trial has compared it to the RYGBP, which is~     remains the gold standard. The first litterature results show similar or even better weight~     loss efficiency than RYGBP with a better feasibility. The early complication rate seems~     lower, but there are still insufficient data on long term morbidity and biliary reflux~     consequences.~      By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the~     investigators study is to analyze the weight loss efficiency, the morbidity and mortality,~     the feasibility, and the quality of life of both techniques, in order to validate the Omega~     loop bypass as a procedure of choice in bariatric surgery~      Hypothesis :~      The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could~     be less morbid.~   "
70137|NCT02139306|"~     This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,~     efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis~     (nmCF) not receiving chronic inhaled aminoglycosides.~   "
70099|NCT02139800|"~     This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which~     of two strategies at birth are best to optimally aerate the lung of preterm infants.~     Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring~     respiratory support at birth which of two lung opening strategies - either a standard~     PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment~     using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined~     endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.~      Hypotheses:~        1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will~          reduce the need for mechanical ventilation in the first seven days of life, and reduce~          need for surfactant use; and~        2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36~          weeks post-menstrual age (PMA) than standard PEEP/CPAP~   "
70100|NCT02139787|"~     The purpose of this study is to use a community based participatory action research (CBPAR)~     approach to 1) create radio stories about Somali, Latino and Hmong families' real success~     stories with hypertension and obesity in managing their disease through implementation of~     healthful lifestyle behaviors (nutrition and physical activity), and 2) test the~     effectiveness and acceptability of radio stories on participant intentions to engage in or~     improve healthful lifestyle behaviors to prevent these disease. Participants in the~     Intervention condition listened to the radio stories and the participants in the control~     condition listened to an audio brochure with relevant health information. We hypothesized~     that the intervention participants would report higher intentions to engage in various~     healthful lifestyle behaviors than the control participants after both participants listened~     to their respective health information.~   "
70101|NCT02139774|"~     This study is testing a walking program called Walk with Ease by the Arthritis Foundation~     with men undergoing treatment for prostate cancer. The researchers are interested in how~     easy or difficult it is for these men to participate in this program and whether or not is~     is helpful to them during their care.~   "
70102|NCT02139761|"~     Cocaine continues to be one of the most widely used substances of abuse around the world. In~     the US, an estimated 1.4 million individuals (0.5%) > 12 years were current (past month)~     cocaine users in 2011. Currently, no FDA-approved pharmacologic treatments are available for~     cocaine addiction; thus, this remains a serious public health problem without an effective~     pharmacological treatment. A promising lead towards an effective treatment comes from a~     recent finding that pretreatment with oral l-tetrahydropalmitine (l-THP) in rats attenuated~     the cocaine seeking associated with a cocaine challenge, while having no motor effects. This~     finding stimulated our group to test the pharmacokinetics and safety of l-THP in a phase I~     study of people with cocaine use. Preliminary findings show l-THP is safe and well tolerated~     in cocaine users, with no adverse interactions with cocaine.~      This study will test the efficacy and safety of l-THP for abstinence in those with cocaine~     addiction in a phase II pilot study (N=24). Secondarily, we will examine the effects of~     these medications on craving.~   "
70103|NCT02139748|"~     Dental implant placement and simultaneous grafting using one layer gum graft will result in~     the same facial ridge contour and soft tissue thickness as one layer of gum graft plus bone~     graft.~   "
70104|NCT02139735|"~     The combination of ultrasound and muscular stretching may have positive effects on pain~     relief and on the balance of the masticatory muscles activity.~   "
70105|NCT02139722|"~     Liver cancer and hepatitis B are major health disparities for Asian Americans, while~     hepatitis C is a rising problem. Little is known about how to improve the quality of health~     care Asian Americans receive in general and for viral hepatitis in particular. Technology,~     specifically mobile applications, potentially can provide a flexible and efficient way to~     address these challenges. This proposed project seeks to develop, implement, and test an~     intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare~     systems in the San Francisco Bay Area.~      The research team will develop, implement, and evaluate the efficacy of an interactive,~     patient- centered mobile application for use on a tablet computer to increase the rate of~     hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will~     use their experience from a successful track record in health promotion to develop the~     intervention by working with patients, community leaders and advocates, clinical staff,~     healthcare providers, and healthcare system administrators from a county safety net system~     and an academic primary care practice in the San Francisco Bay Area. The mobile application~     will include video clips with a physician (Video Doctor) addressing patient concerns~     regarding hepatitis B and C screening in the patient's preferred language, English, Chinese,~     or Vietnamese. A patient who has not been screened for hepatitis B will answer questions~     about his or her characteristics and preferences using the mobile application. The mobile~     application will then show 30-60 seconds video clips with messages that address the~     patient's responses related to hepatitis B screening and that are delivered by an actor~     playing a physician. Those who are born between 1945 and 1965 also receive messages about~     hepatitis C screening. At the end, the tablet computer will generate a provider alert to let~     the treating provider know what the patient's preferences are regarding testing for viral~     hepatitis.~      Once developed, the intervention will then be used in combination with a physician panel~     notification and tested against physician panel notification only in a randomized controlled~     trial to see which approach is better in increasing the rate of hepatitis B and C screening.~     The team will also work with the 2 healthcare system to ensure that the interventions will~     be practical and easily adopted once the study is over. The findings of this project will~     greatly expand understanding about how to use technology- based interventions to improve~     quality of healthcare in diverse patient populations.~   "
70106|NCT02139709|"~     The overall objective of this study is to demonstrate how dietary ganglioside may protect~     the gut attenuate inflammatory signals in the intestinal mucosa.~      Gangliosides are dietary fats found in milk and are important constituents of intestinal~     cells. Our previous studies have shown that inflamed intestinal mucosal cells have reduced~     ganglioside content compared to normal mucosal cells. Gangliosides are glycolipids found on~     the surface of the intestinal mucosa and in lipid rafts in enterocytes and lymphocytes.~     Gangliosides influence microbial attachment, cell division, differentiation, signaling and~     mucosal integrity. Preclinical studies show that provision of ganglioside in cell culture~     and in animal diets increase ganglioside content in mucosal cells and down regulates signals~     caused by pro-inflammatory stimuli. In subjects with active Crohn's disease, consumption of~     ganglioside remarkably improved the Crohn's Disease Activity Index. In healthy control~     subjects, dietary ganglioside improved intestinal permeability and decreased production of~     pro-inflammatory prostaglandin E2.~      It is proposed that ganglioside degradation is elevated in the inflamed gut of IBD patients.~     Provision of ganglioside in the diet replaces ganglioside in the gut, consequently restoring~     proper structure and function to the diseased intestine and inducing disease remission.~     Insight into diet-based treatment would allow IBD patients to live healthy and happy lives.~     The main research objective is to characterize how ganglioside catabolism is associated with~     increased signaling from pro-inflammatory mediators and how reduction in ganglioside levels~     can be ameliorated by ganglioside supplementation during active inflammatory disease. This~     study will assess molecular mechanisms by which ganglioside alters gut permeability,~     inflammatory mediators and cell signaling.~   "
70107|NCT02139696|"~     To evaluate the usability of positron emission tomography imaging as a novel outcome measure~     in multiple sclerosis studies~   "
70108|NCT02139683|"~     The purpose of this study is to assess the treatment of fibroadenomata with a~     circumferential sonification treatment with HIFU..~   "
70109|NCT02139670|"~     In total 120 pregnant women's with history of recurrent miscarriages, are planned for~     inclusion in this trial. After signing an informed consent a blood sample will be obtained~     from each participant. The investigators will measure the thrombin generation in plasma~     assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy~     outcome and thrombin measurements will be determined~   "
70112|NCT02139631|"~     The noninvasive ventilation (NIV) is a method of ventilatory support that does not require~     artificial airway. Its application is associated with complex hemodynamic repercussions,~     therefore is important to identify them for safety and effectiveness of the technique~     application.~      The main objective of this research is to evaluate the hemodynamic repercussions using~     doppler echocardiography in healthy volunteers submitted a different values of positive end~     expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway~     pressure (CPAP) and Bilevel.~      The study hypothesis is that the positive end expiratory pressure (PEEP) may cause~     hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after~     load, cardiac output and reduction in the diameter of the superior vena cava, due to the~     increase in the intrathoracic pressure and pulmonary volumes.~   "
70113|NCT02139618|"~     Treatment of actinic damage has included multiple procedures but to date there is limited~     scientific evidence to support the preferential use of one of these therapies according to~     their efficacy, safety and pain tolerance by patients. This study aims to assess the~     efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial~     photodamage~   "
70114|NCT02139605|"~     Stomach cancer is the second most common cause of cancer-related deaths in India. Curative~     surgery offers the only chance of improving survival in this cancer. In patients whose~     cancer has not spread to other parts of the body (beyond the stomach and lymph nodes around~     it), removal of stomach (gastrectomy) with lymph nodes around the stomach and along the~     major vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current~     standard of care at Tata Memorial Centre. However, the extent of lymphadenectomy is~     controversial. Some studies have suggested that removing more lymph nodes, even around the~     major vessels of the abdomen (aorta and inferior vena cava) may not only help to accurately~     determine the disease spread, but may also confer an additional survival benefit. Removing~     more lymph nodes around the major vessels may increase the risk of morbidity to the patient.~      In the last 5-6 years, stomach cancer specialists around the world have resorted to giving~     half the cycles of chemotherapy to the patient before the surgery (neoadjuvant~     chemotherapy), and the other half after the surgery in what is called 'perioperative~     chemotherapy'. This has been shown to lead to more patients surviving to 5 years, than~     before.~      The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may~     constitute the best care for our patients with stomach cancer such that no further removal~     of lymph nodes beyond is required. However, the investigators have no evidence in literature~     to support this hypothesis. The investigators have thus designed this trial based on which~     we propose that there exists no difference between a D2 lymphadenectomy and a D3~     lymphadenectomy following neoadjuvant chemotherapy for non-metastatic, locally advanced but~     resectable gastric cancer. The data will enable the development of clear management~     guidelines for lymph node dissection in stomach cancer.~   "
70115|NCT02139592|"~     The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for~     IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+~     Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as~     well as to collect efficacy information for reference.~   "
70116|NCT02139579|"~     Epidermal growth factor receptor (EGFR) tyrosine kinase is one of most popular target~     molecules in the field of anticancer drug research. EGFR is highly expressed in many types~     of tumor cells, which could activate EGFR cytosolic kinase activity by binding to its ligand~     EGF, and regulates gene expression, cell proliferation, differentiation, apoptosis through~     different signal transduction pathways. Epidermal growth factor receptor tyrosine kinase~     inhibitor (EGFR-TKI), competitive to specifically combined with the EGFR kinase domain, thus~     inhibits its kinase activity, thereby blocking cancer cell proliferation or metastasis. At~     present, EGFR-TKI has been widely used in clinical activity, especially in patients with~     EGFR mutations, which had been proved to achieved a certain effect. But with the passage of~     time, a drug resistance is inevitable.~      At present, studies have found that the cessation of treatment immediately after EGFR-TKI~     resistance may lead to rapid progress of cancer. Chemotherapy, as one of the most widely~     accepted modality in cancer treatment, might also be one of the salvage therapies of target~     treatment. Therefore, in patients with better physical status (PS) scores, chemotherapy is~     commonly applicable.~      In January 2010, a study published in the journal of Clinical Lung Cancer reported the~     application of chemotherapy as salvage treatment for advanced non-small cell lung cancer~     (NSCLC) patients with resistant to first-line EGFR-TKI treatment. Of the 114 patients~     enrolled, 67 received sequential chemotherapy, the other 47 patients received best~     supportive care. The results showed that, sequential chemotherapy can improve the survival~     time of the patients, compared with chemotherapy and supportive care groups (11.2 months vs.~     3.8 months, P< 0.01). Furthermore, in those who received sequential chemotherapy, a regimen~     containing paclitaxel got higher efficiency and disease control rate than those without~     (48.7% vs. 21.4%, 79.5% vs. 53.5% , P< 0.05), as well as longer progression-free survival~     (PFS, 5.1 months vs. 1.8 months, P< 0.01) and overall survival (OS, 12.7 months vs. 7~     months, P< 0.01).~      Another study in Taiwan which enrolled 195 patients treated with at least 1 cycles~     sequential chemotherapy after first-line gefitinib shown similar results. Generally,~     gefitinib as a first-line treatment had PFS for 5 months, and the second-line treatment~     efficiency was 14.4%. Regimens of platinum or paclitaxel had a better treatment efficiency~     (50.6%). A poor therapeutic effect was reported for gefitinib as second-line therapy (5.6%).~     In total, the median OS of second-line treatment was 12.2 months. In addition, platinum~     containing regimens survival better (21.7 months vs. 8.9 months, P< 0.01); patients with~     mutant EGFR benefit more in a platinum-based chemotherapy (24.5 months vs. 8.5 months, P<~     0.05).~      Bevacizumab (trade name Avastin ®) is a kind of recombinant humanized monoclonal~     immunoglobulin gamma-1 (IgG1) antibody, which can selectively inhibit the combination~     process of vascular endothelial growth factor (VEGF) and its receptor, Flt-1 and kinase~     domain receptor (KDR) in endothelial cells. A reduction of tumor angiogenesis, blood supply,~     oxygen and other nutrients supply could be obtained after the VEGF loss of its biological~     activity, thus inhibit tumor growth. The drug was approved for the first-line treatment of~     advanced colorectal cancer in 2004 by America food and Drug Administration (FDA),thus became~     the first for clinical use of drugs that targeting VEGF. As the first globally approved~     anti-angiogenic monoclonal antibody drugs, bevacizumab has approved for advanced colorectal~     cancer, lung cancer, breast cancer, renal cell carcinoma and malignant glioma patients,~     which was used in more than 500000 cases. In the field of advanced NSCLC treatment, clinical~     results confirm bevacizumab combined with chemotherapy can prolong OS and PFS of patients~     with NSCLC, and well tolerated.~      The thirty-fifth annual meeting of the European Society of Medical Oncology (ESMO)~     conference released a meta analysis results of bevacizumab combined with platinum~     chemotherapy for first-line treatment of advanced non squamous NSCLC. It is confirmed that,~     treatment with bevacizumab based chemotherapy for advanced non squamous NSCLC patients could~     achieve significant survival benefit, prolong remission time, and expected safety.~      Therefore, the investigators design this phase II to testify the efficacy and safety of~     bevacizumab + chemotherapy for EGFR-TKI resistant non squamous NSCLC.~   "
70117|NCT02139566|"~     A two-part study to test the efficacy of alternative consent procedures and the efficacy of~     alternative methods to improve survey completion.~   "
70118|NCT02139553|"~     The purpose of this study is to determine whether rhythmic upper-limb movement training in~     post-stroke patients allows to improve only this particular type of movements or if it also~     improves some parameters of discrete movements. Based on our results we hope to be able to~     answer a fundamental question: are rhythmic and discrete movements two independent~     primitives?~   "
70119|NCT02139540|"~     Major depressive disorder (MDD) is a global medical problem with significant shortcomings in~     current therapy. Chief among these is the delay between initiation of pharmacologic therapy~     and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has~     been shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another~     NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and~     perhaps without the need for intravenous access and anesthesia personnel. Therefore, we~     propose conducting a pilot randomized placebo controlled double-blind crossover study in~     which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for~     a period of one hour in addition to standard medical therapy. Depression severity will be~     assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using~     the Hamilton depression rating scale.~   "
70120|NCT02139527|"~     The purpose of the registry is to assess outcomes following treatment with lumbar total disc~     replacement (TDR) in patients outside the clinical trial setting.~   "
70121|NCT02139514|"~     The purpose of this study is to predict and explain on the basis of brain function and~     structure the behavioral and brain effects of an evidence-based intervention for adults with~     high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012;~     Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned~     to receive either (a) two hours per week of intervention services for five weeks, or (b) a~     treatment as usual control. The intervention will focus on enhancing social skills, social~     cognition, and social functioning. Outcome measures will evaluate changes in these social~     skills, cognition, and functioning using standardized assessments. We will perform~     structural and functional magnetic resonance imaging (MRI) scans at three time~     points-before, during, and after treatment (i.e., Time Point #1, 2, and 3).~   "
70122|NCT02139501|"~     The project was undertaking by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to study the efficacy and safety of different dose and~     frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia~     (ITP)~   "
70123|NCT02139488|"~     To quantify motion based variation of the target volume of the primary tumor over the course~     of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate~     appropriate PTV (planning target volume) margins according to the margins recipe for~     patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive~     chemoradiation in order to personalize radiation treatment, resulting in either better~     target coverage or a reduction in normal tissue radiation exposure.~   "
70138|NCT02139293|"~     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous~     system stimulation on cardiovascular parameters and sympathovagal balance in healthy~     subjects. It is investigated if auricular vagal nerve stimulation affects heart rate~     variability as well as peripheral local blood perfusion, and if this effect depends on the~     site of stimulation in the auricle, whereas four distinct stimulation points are tested.~   "
70944|NCT02128750|"~     The primary objective of our work is to show that quantification of muscular~     microvascularisation evaluated by injection of contrast agent is different between chronic~     critical limb ischemia (before revascularization) and after (healing of ischemia) and thus~     make the proof of its utility in evaluation of PAD therapeutics.~   "
70124|NCT02139475|"~     The aim of this study is to clarify the factors influencing quality of bowel cleansing for~     colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel~     cleaning method for patients with colorectal cancer surgery. Through this, ultimately in~     patients with a history of colorectal cancer who have high risk of colorectal cancer, it~     could be possible to detect cancerous lesions early and increase the survival rate.~      This study is based on observational study Subjects are the patients with colorectal cancer~     surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical~     records on the basis of information collected at the point of the colonoscopy performed~     Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient~     compliance and satisfaction are measured.~   "
70125|NCT02139462|"~     This study will use a data base of archived therapy sessions of family therapy for~     adolescent anorexia nervosa to determine the role of fidelity to treatment and outcome. In~     addition, it will develop a novel, more efficient way to train therapists in family therapy~     for adolescent anorexia nervosa and examine if it is feasible to conduct a trial comparing~     this novel training to standard, more intensive training.~   "
70126|NCT02139449|"~     CRT and ICD has known as decreasing cardiac mortality in patient with heart failure.~     Especially, it has reported that CRT improved cardiac systolic function, quality of life of~     patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So~     we will register patients who implant CRT or ICD (primary), and follow them up. During~     scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG,~     Holter monitoring and questionnaire on QOL.~   "
70127|NCT02139436|"~     Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first~     year, there are profound declines in physiologic function, forming the underlying substrate~     for future cardiovascular disease . In fact, acquired cardiovascular disease is an~     increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though~     incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in~     part from profound physiologic 'detraining' resulting from motor impairment and immobility.~     Currently, effective interventions preventing acute declines that lead to cardiovascular~     compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is~     challenging and when employed, is typically limited to the upper body. Recently, the~     investigators refined a unique form of exercise for those with SCI that specifically mirrors~     exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row~     Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in~     a hemodynamic profile that produces the beneficial cardiac loading conditions of large~     muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate~     cardiovascular declines following SCI. The investigators aims are to test the overall~     hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced~     insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function,~     and 3) counter ventricular wall thickening and declining ventricular function occurring with~     acute SCI, and that these effects will be greater than that observed with an arms-only~     exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to~     arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to~     immediate FES-RT, to a time control beginning FES-RT after a 6 month wait, or 6 months of~     arms-only-RT followed by FES-RT. Measures will be made at baseline and every 3 months. The~     investigators work will provide results that clearly delineate potential health benefits of~     FES-RT, and if FES-RT is effective in a majority of those with SCI, its application,~     implementation, and integration could be easily replicated.~   "
70128|NCT02139423|"~     Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in~     most maternities in France to detect symptomatic hearing impairment at birth but screening~     of cCMV infection is not coupled with this screening. In this study, the feasibility of~     achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as~     the confirmation of hearing loss in newborns who failed newborn hearing screening will be~     tested.~   "
70129|NCT02139410|"~     Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation~     of this hormone has been reported to influence the genesis of cognitive impairment and~     dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of~     Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.~   "
70130|NCT02139397|"~     The purpose of this research study is to evaluate an investigational drug (DFMO) in~     combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an~     investigational drug because it has not been approved by the U.S. Food and Drug~     Administration (FDA). This study will look at the safety and tolerability of DFMO in~     combination with bortezomib as well as the tumors response to this study drug.~   "
70131|NCT02139384|"~     The purpose of the study is to create a clinical pneumonia tool that can be used to predict~     the cause of community-acquired pneumonia, which is a lung infection that began outside of~     the hospital in critically ill children therefore limiting unnecessary antibiotic use. The~     investigators will enroll critically ill children admitted with acute respiratory failure~     and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from~     culture and respiratory viral panel results. All care after samples obtained will be at the~     discretion of the PICU team. The investigators believe that our clinical pneumonia scale~     with procalcitonin will accurately designate viral from bacterial etiologies.~   "
70132|NCT02139371|"~     The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for~     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential~     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and~     less aggressive tumors. This is a first in human study to test the radiotracer in cancer~     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging~     (1,3 and 24 hours post injection).~   "
70133|NCT02139358|"~     The purpose of this study is to evaluate the safety and activity of gemcitabine plus~     trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor~     receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of~     chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.~   "
70134|NCT02139345|"~     This is a prospective, randomized, multicenter clinical study to compare the safety and~     efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese~     subjects.~   "
70135|NCT02139332|"~     The purpose of this study is to to conduct a randomized controlled trial comparing an~     intervention group and a control group to evaluate the feasibility of the Promoting First~     Relationships method in an American Indian community through their tribal Health Promotion~     program, and to assess the efficacy of the method in this community.~   "
70136|NCT02139319|"~     The purpose of the study is to evaluate the safety and tolerability of the drug product at~     each dose level.~   "
70139|NCT02139280|"~     No prospective randomized trials have evaluated the most efficacious dose of~     cyclophosphamide to mobilize autologous stem cells. We previously demonstrated that the time~     to collection of autologous hematopoietic stem cells is 10-12 days following the one dose of~     cyclophosphamide and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective~     randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2)~     will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected,~     number of apheresis required and resource utilization.~   "
70140|NCT02139267|"~     The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and~     access the efficacy and safety of GX-188E according the protocol in patients with Cervical~     Intraepithelial Neoplasia 3 (CIN3).~   "
70141|NCT02139254|"~     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or~     first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized~     before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much~     has been invested to uniformly define worldwide the diagnostic criteria and the management~     of gestational diabetes. A general screening in a low risk population should be implemented~     into routine prenatal care. Similarly, pregnant women at high risk for metabolic disorders~     should be screened in the early pregnancy.~      The aim of the following study ist to investigate the role of first trimester glycosylated~     haemoglobin (HbA1c) of pregnant women with risk factors in developing gestational diabetes~     mellitus (GDM).~   "
70142|NCT02139241|"~     The purpose of this study is to assess the effects of ramosetron on corrected QT interval in~     patients undergoing off pump coronary artery bypass surgery.~   "
70143|NCT02139228|"~     Evaluate the persistency of immune response against Haemophilus influenzae type b by~     assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT~     booster vaccine approximately 4 years before.~   "
70144|NCT02139215|"~     This is a phase IV multicenter trial to evaluate real-world health outcomes and economic~     impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~      The study will enable real-life health economics and outcome research (HEOR) to assess the~     impact of panitumumab in the Quebec population.~      The primary objective is to evaluate real-world health outcomes and economic impact of~     panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison~     with SOC. The secondary objectives are to confirm survival data, to assess the quality of~     life of patients and to assess the health care resource utilization of patients.~      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients~     with a non-mutated (wild type) KRAS gene will be treated with panitumumab.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in~     the study and at every 3 months after treatment initiation.~   "
70145|NCT02139202|"~     This is a 6-month pilot study intended to test the effect of financial incentives on~     improving medication adherence in AMI patients; to test the effect on adherence of removing~     financial incentives; and to test the effect on the enrollment rate of modifying recruitment~     procedures.~   "
70146|NCT02139189|"~     The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety~     and functional effect of the CorMatrix P-ECM.~   "
70147|NCT02139176|"~     In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven~     challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking~     behaviors than women. They are less likely to be tested for HIV, initiate combination~     antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage~     in the care of their female sex partners, even though couple care-seeking is associated with~     marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program~     for providing immediate, lifelong combination antiretroviral therapy (cART) to all~     HIV-infected pregnant women at the time of diagnosis, is an important entry-point for~     involving male partners in care.~      This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male~     partner involvement within the Option B+ program. In both arms (patient referral and~     contract referral) women will be encouraged to invite their male partners to accompany them~     to the clinic for couple HIV counseling and testing. In the contract referral arm, if the~     couple does not present within one week, the male partner will receive a home visit~     encouraging them to present to the clinic. We will compare the two arms for 1) uptake of~     couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to~     care for HIV-infected men. Results are expected to inform a larger trial and ultimately~     improve care-seeking in Malawi's HIV program.~      Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option~     B+ context. We will assess acceptability of eligible females to participate in this pilot~     RCT and reasons for non-participation.~      Objective 2: Assess whether study arm (patient referral versus contract referral) is~     associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of~     male partner recruitment. This study will contain two arms: patient referral and contract~     referral for uptake of cHTC (primary outcome).~   "
70148|NCT02139163|"~     Long-term objectives of the basic research part are improvement of CAP-management with~     respect to therapy, diagnosis and prevention to contribute to a better care of patients with~     pneumonia.~   "
70149|NCT02139150|"~     The purpose of this study is to see if PET/CT scans that use a radioactive substance called~     [18F] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive~     substances are used with PET/CT scans to see cancer cells, and are also called~     radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT~     PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard~     clinical scan and is commonly used. The investigators would like to know if there is any~     evidence of early treatment response by obtaining FLTPET/ CT scans before and after~     treatment.~   "
70150|NCT02139137|"~     The study is designed to evaluate the effect of a novel computer training program on PTSD.~   "
70151|NCT02139124|"~     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to~     evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD~   "
70152|NCT02139111|"~     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to~     evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.~   "
70153|NCT02139098|"~     The purpose of this study is to evaluate whether drug efficiency of zolpidem and~     amitriptyline can be conditioned according to learning theory in patients with primary~     insomnia.~   "
70173|NCT02138838|"~     This is a phase 3, 24-week, randomized, multicenter, open-label, controlled study. subjects~     will be randomized into one of two treatment arms; oral administration of cinacalcet daily~     in addition to standard of care treatment arm or a standard of care arm. Randomization will~     be stratified by age group. All subjects receive standard of care which can include therapy~     with Vitamin D sterols, calcium supplementation, and phosphate binders.~   "
70154|NCT02139085|"~     Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that~     adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency~     treatment have a lower risk of iatrogenic injuries and offer faster return to work~     activities, when compared with open surgical techniques. Endovenous electrocoagulation can~     selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical~     results has never been studied before.~      Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation~     and radio frequency (RF) endovascular varicose vein treatment clinical results and quality~     of life improvement in a prospective double blind randomized controlled clinical trial.~      Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized~     to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure~     will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning~     (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising,~     neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and~     Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical~     Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained~     preoperatively, at 3 and 6 months postoperatively. For statistical analysis, we will use the~     Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive~     statistical significance when level of p <0.05.~   "
70155|NCT02139072|"~     The purpose of this study is to see if the CoaguChek XS is accurate in measuring~     International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome~     (APL) receiving warfarin therapy.~   "
70156|NCT02139059|"~     To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy~     without initial urinary drainage in the treatment of obstructive calcular anuria with acute~     renal failure in children.~   "
70157|NCT02139046|"~     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg~     extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release~     (IR) and 80 mg IR, respectively, in participants with gout.~   "
70158|NCT02139033|"~     This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs~     and symptoms of dry eye syndrome.~   "
70159|NCT02139020|"~     The investigators will collect plasma samples at baseline, during treatment, and at~     progression.~   "
70160|NCT02139007|"~     This is a pilot study evaluating the recruitment strategies for sites and patients, data~     collection instruments, follow-up procedures, administrative processes, and the proposed~     management strategy for the future large scale national trial. This pilot study is 6 months~     in length.~   "
70161|NCT02138994|"~     This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients~     diagnosed with a chronic wound. The primary objective is to assess changes in healing rate,~     by measuring differences in wound area when treating chronic wounds with the Next Science~     Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At~     the end of the study period, patients may continue receiving their assigned study treatment~     provided they have signed the Continuation of Treatment Informed Consent and the rational~     for continuation is documented by the investigator.~   "
70162|NCT02138981|"~     The purpose of this study is to compare the survival outcomes between hepatic resection and~     transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients~     with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.~   "
70163|NCT02138968|"~     The study intervention improves functional capacity and delays frailty status in pre-frail~     elderly subjects.~   "
70164|NCT02138955|"~     This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer~     patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body~     surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour~     infusion once weekly for 8 weeks.~   "
70165|NCT02138942|"~     The main objective of this study is to demonstrate that the LIR (Learning Intravenous~     Resuscitator) Closed-Loop Fluid Administration System (hereafter the LIR system), a new~     device for the automated administration of intravenous fluids during major abominal surgery~     and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid),~     maintains blood volume at values that are acceptable by the gold standard, i.e. the~     anesthetist in charge of the patient.~   "
70166|NCT02138929|"~     The goal of this clinical research study is to find the highest tolerable dose of LDE225~     that can be given in combination with everolimus to patients with esophageal or GEJ cancer.~     The safety of the drug combination will also be studied.~   "
70167|NCT02138916|"~     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in~     symptomatic patients with moderate to very severe COPD who are receiving standard of care~     therapies~   "
70168|NCT02138903|"~     Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical~     ventilation in ICU patients of two French ICU.~   "
70169|NCT02138890|"~     This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the~     efficacy of a single dose of Autologous Protein Solution (APS) in patients with~     osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA)~     therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).~   "
70170|NCT02138877|"~     to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an~     after coming stent versus stentless pyeloplasty.~   "
70171|NCT02138864|"~     The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of~     Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its~     correlation with clinical parameters. This study is expected to be completed in a period of~     3 years.~   "
70172|NCT02138851|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fig paste on functional constipation. The~     investigators measured colon transit time, frequency of defecation, defecation time, stool~     type, and abdominal discomfort.~   "
70174|NCT02138825|"~     To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in~     patients with symptomatic PH (pulmonary hypertension) associated with IIP(idiopathic~     interstitial pneumonias).~   "
70179|NCT02138760|"~     Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy~     have a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance~     imaging (mpMRI) is an imaging test that may improve prostate cancer detection rates in this~     population of men. In this prospective randomized trial multicenter trial the investigators~     will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared~     with the addition of either a computer targeted system (UroNav - InVivo corp) to sample~     suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy~     (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided~     biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of~     these areas and systematic biopsy alone.~   "
70180|NCT02138747|"~     The purpose of this study was to assess tolerability of mirabegron compared to tolterodine~     ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the~     impact of treatment on micturition frequency and incontinence episodes.~   "
70181|NCT02138734|"~     This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus~     ALT-803 in Non-muscle invasive bladder cancer.~   "
70182|NCT02138721|"~     The objective of this study is to evaluate the role of local treatment with radical~     prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.~   "
70183|NCT02138708|"~     The purpose of this study is to assess the predictive performance of the pulmonary vascular~     reactivity to acetylcholine, in the presence pulmonary arterial hypertension (estimated 1~     year after the closure of the shunt).~   "
70184|NCT02138695|"~     1. Purpose of the study~      1) To explore clinical recurrence associated clinical factors including age, sex, clinical,~     electrophysiological, anatomical, imaging, and serologic characteristics.~      2) To develop simulation model to predict clinical recurrence and the efficacy of catheter~     ablation 2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. clinical outcome after catheter ablation is affected not only by age, sex and~          underlying disease, but also by electrophysiologic, imaging, serologic and~          electroanatomical remodeling of the heart. However, there are few studies concerning~          these multifactorial variables.~      3. Study population~   "
70185|NCT02138682|"~     This investigator initiated trial is designed to measure the accuracy of diagnosis of~     Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure~     dopamine transporter densities in human tissue. This measurement can assist in~     distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson~     disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will~     compare both clinical diagnosis of symptoms and the results of the scan to the pathological~     diagnosis received at time of death. Patients will be registered in the Parkinson Research~     Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have~     their brain scanned using DaTscan, and donate their tissue for research and autopsy~     purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson~     Disease as accurately as a clinician.~   "
70186|NCT02138669|"~     The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in~     April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters).~     Additional clinical data have shown that INTACS are safe for the treatment of keratoconus,~     in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian~     Use Device (FDA approval letter attached). The statute and the implementing regulation of~     FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS~     prescription inserts are composed of two clear segments, each having an arc length of 150°,~     they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and~     are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may~     be implanted depending on the orientation of the cone and the amount of myopia and~     astigmatism to be reduced.~   "
70187|NCT02138656|"~     The purpose of this study is to investigate whether a course of chiropractic treatment has a~     significant impact on the natural course of infantile colic, specifically:~        1. Do parents of colicky infants randomised to the groups receiving a course of McTimoney~          chiropractic treatment:~             -  report a significantly greater improvement in hours of crying than those in the~               control group?~             -  report a significantly greater improvement their own quality of life (anxiety and~               depression)?~             -  report resolution of colic following treatment than the control group?~        2. What effect does parental blinding have on parentally-reported symptoms of infantile~          colic and parental quality of life?~      The study will also include exploratory investigations to determine whether there are:~        1. Any particular groupings of patient characteristics (for example; 'other' presenting~          symptoms, position in the natural course of colic, age of onset, spinal dysfunction,~          perinatal factors) that are associated with good or poor outcomes~        2. Any particular characteristics of the treatment (e.g. specific adjustments) that are~          associated with good or poor outcomes.~   "
70197|NCT02138526|"~     Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell~     carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is~     administered at a fixed oral dose of 800 mg once daily (OD) regardless of size, age and~     clinical condition. It is absorbed from the gastrointestinal tract with an oral~     bioavailability of ~21%. Pazopanib is practically insoluble and highly permeable. When~     ingested with high fat food the pazopanib exposure (area under the concentration time curve~     (AUC)) is doubled. Common adverse effects are diarrhea and nausea. This might be caused by~     the non-absorbed proportion of pazopanib. A reduced dose taken with food could be a possible~     approach to reduce these side effects. Therefore the investigators initially want to~     determine the equivalent reduced dose of pazopanib when taken with a continental breakfast.~     Thereafter the investigators want to investigate whether the intake with food reduces the~     frequently reported side effects nausea and diarrhea.~   "
70188|NCT02138643|"~     Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax~     the lower esophageal sphincter ( LES) in response to swallowing associated with lack of~     peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and~     occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting~     in a large impact on daily activities and quality of life of affected individuals .~      There is currently considered curative treatment for achalasia , dysphagia relief being the~     primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus ,~     the most commonly used endoscopic treatments are forced dilatation of the cardia and~     botulinum toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is~     considered gold standard  because of excellent results and minimal invasiveness. Currently~     , pneumatic dilation and surgical treatment with the Heller myotomy with fundoplication are~     strongly associated with the best therapeutic options available .~      In recent years, the possibility of using endoluminal access in the treatment of achalasia~     patients through the technique originally described as Natural orifices Translumenal~     Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled~     the concomitant development of a new approach described as perioral endoscopic myotomy . In~     2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a~     submucosal tunnel initially in an animal model . The first performance of this procedure in~     humans was described by Inoue et al , in 2010 , introducing the concept of transluminal~     endoscopic surgery through natural orifices , with the objective of minimizing the trauma~     and all the stress resulting from open surgical procedure . These authors call the procedure~     as POEM ( Per Oral Endoscopic myotomy ) .~   "
70189|NCT02138630|"~     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate~     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy~     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid~     for weight loss supplements. Owing to the fact that these changes are believed to be driven~     by catecholamine release and alterations in fat oxidation, there is growing belief that~     capsaicin may also offer potential ergogenic benefits (performance enhancement) during~     exercise, similar to the affect of caffeine, which works through similar pathways. Of~     particular interest are the recent findings that free-fatty acids in the blood are elevated~     2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone~     indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative~     consequences of other stimulants may be avoided. At present, however, more in depth~     investigations of the effects on endothelial function, vascular autonomic tone and~     inflammation are lacking.~      Although there are some indications that capsaicinoid ingestion may alter factors associated~     exercise performance (such as increased fat oxidation for glucose sparing), to date these~     studies have primarily used very low exercise intensities wherein these effects are~     typically unnecessary, and results are not generalizable to the typical race intensities of~     endurance sport competition. Performance measures have also been a noticeably absent outcome~     from research to date.~      Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated~     for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of~     causing intensity to go up 3) During sustained aerobic activity approaching the aerobic~     threshold alterations in substrate use will be minimal (but possibly meaningful in regard to~     performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post~     single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects~     observed for more prolonged exposure in phase 1.~   "
70190|NCT02138617|"~     This study involves standard combination chemotherapy treatment for colon cancer,~     5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab~     (Avastin). The study is designed to test the FOLFIRI regimen based on certain~     characteristics of a person's genetic makeup or genes. Genes are made of DNA and determine~     not only inherited traits or appearance (hair and eye color, height, body type, etc.) but~     also play an important role in health and how the body responds to illness and treatments~     for those illnesses.~      In this study, the investigators will examine the relationship between a patient's genes~     (DNA), or genotype, and how the patient's body breaks down and removes or metabolizes~     the anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important~     role in how well this drug works against a patient's cancer as well as the adverse side~     effects the patient may experience. The current standard dose of irinotecan was determined~     in clinical trials without knowing individual genotypes and thus does not take into account~     a patient's ability to metabolize irinotecan. This means that based on one genotype the~     current standard dose of irinotecan may be correct or based on other genotypes the standard~     dose could result in lower and possibly less effective blood levels and result in~     significant under-dosing of irinotecan.~      Based on genotype the patient will be assigned to one of the following doses of irinotecan:~        -  180 mg/m2 (standard dose)~        -  260 mg/m2~        -  310 mg/m2~      The purpose of this research study is to determine if dosing irinotecan based on genotype is~     effective and safe for patients with colon cancer. Patient genotype will be determined from~     a small sample of blood and a laboratory test or assay performed at UNC Laboratories. For~     the purpose of this study, this assay is new and considered to be investigational. This~     means that the genotype assay used in this study has not yet been approved by the FDA for~     determining irinotecan dose levels in patients with colon cancer.~   "
70191|NCT02138604|"~     Most patients presenting to the emergency department with chest discomfort have a~     nonischemic ECG and biomarkers of myocardial necrosis within normal limits. These patients~     are routinely admitted to hospital because of diagnostic uncertainty for occult MI or~     ischaemia.~      Acute myocardial ischemia is associated with acute mycardial dysfunction We tested a~     non-invasive plethysmographic arterial pressure change index of myocardial performance~     (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding~     unnecessary admissions.~   "
70192|NCT02138591|"~     Vitamin D (Vitamin D) deficiency is very common. We recently showed that 97% of 204 patients~     admitted to Truman Medical Center were Vitamin D deficient (<30 ng/ml). However, the~     consequences of Vitamin D deficiency, particularly with respect to infection, are not well~     understood. It is known that production of cathelicidin, an important antimicrobial peptide,~     is critically dependent upon Vitamin D. It is also established that levels of cathelicidin~     correlate inversely with urinary tract infection risk. We hypothesize that restoration of~     Vitamin D levels to normal in patients undergoing major surgery will result in significant~     decreases in levels of perioperative infections due to restoration of normal levels of~     circulating Vitamin D, which in turn will elevate cathelicidin levels. As an initial test of~     this hypothesis, we propose a double-blind, prospective, randomized study of pre-operative~     Vitamin D supplementation. Fifty subjects undergoing surgery will receive daily Vitamin D3~     (50,000 IU) for five days pre-operatively, with controls receiving placebo. Levels of~     Vitamin D, calcium, cathelicidin, and the pro-inflammatory protein resistin, will be~     monitored before Vitamin D supplementation (pre-operatively) and after Vitamin D~     supplementation (post-operative days 1 and 2). The effect of these changes should be to~     decrease the incidence of infectious complications. We expect to observe Vitamin D levels~     increase to normal, and cathelicidin levels become elevated. We expect to see increased~     levels of resistin in patients developing infections. This study will provide strong pilot~     evidence for future NIH funding.~   "
70193|NCT02138578|"~     This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide~     comparable local control, with similar or improved toxicity rates compared to Radio~     Frequency Ablation (RFA) when treating small renal cell carcinomas.~   "
70194|NCT02138565|"~     Primary hypothesis:~      A large reduction in weight is not associated with a change in accurately measured~     glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma~     clearance (51Cr-EDTA)).~      Secondary hypothesis:~      A large reduction in weight is associated with a greater change in estimated GFR (The~     Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.~      Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology~     Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately~     measured GFR.~   "
70198|NCT02138513|"~     Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing~     anxiety, depression and fatigue in cancer patients. As this intervention can be offered in~     groups, costs are relatively low. In addition, delivering MBCT online might make the~     intervention more accessible and cost-effectiveness. However, more information is needed~     about what treatment works best for which patient.~      Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both~     individual MBCT online and MBCT offered as a group training compared to TAU .~      Study design: The design of the study will be a multi-centre, randomised, superiority trial,~     comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU~     condition will be randomised to one of the treatment conditions after 3 months. Main~     assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months~     after post-treatment (T3).~      We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness~     skills, anxiety and depressive compants, psychological well-being, rumination and fear of~     cancer recurrence. We also expect the MBCT to result in patients returning to work earlier,~     have a higher work ability and have lower medical care costs, thereby being more~     cost-effective than TAU.~   "
70199|NCT02138500|"~     This study will see how PF-06372865, an experimental drug distributes in the brain after one~     dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will~     also evaluate the safety and tolerability of PF-06372865in these subjects and will measure~     the level of PF-06372865 in the blood.~   "
70200|NCT02138487|"~     The investigators are conducting a study to better understand the relationship between~     activity restrictions and women's satisfaction following urogynecologic surgery for~     prolapse. We hypothesize that women with less stringent postoperative restrictions will have~     higher levels of satisfaction 12 weeks following surgery with no difference in respect to~     anatomic outcome.~   "
70201|NCT02138474|"~     Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a~     number of absences from, and decreased performances at, work and school as well as~     recreational activities. CTTHs typically occur at least 15 times a month or at least every~     second day, and present as an achy or tight sensation that is felt around the head . The~     pain may last from 30 minutes to several days and varies in intensity . Conventional~     treatment is palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs~     (NSAIDs), which may produce adverse effects and analgesic rebound headaches . Lacticum~     acidum 30CH is a homoeopathic remedy that has been shown to have potential benefits in the~     treatment of CTTHs . Homaccords are the preparation of one remedy in multiple increasing~     potencies in a single vehicle . There has been no research done to date on Lacticum acidum~     Homaccord in the treatment of CTTHs.The aim of this study is to determine the efficacy of~     Lacticum acidum Homaccord in the treatment of chronic tension-type headaches, using the~     modified Headache Diary and the Headache Disability Inventory.~   "
70202|NCT02138461|"~     This study examines patient perceptions regarding the tolerability of two classes of~     glaucoma medication: bimatoprost and latanoprost.~   "
70203|NCT02138448|"~     Cancer screening can improve the length and quality of life, yet the average American~     receives only half of recommended services. Patient-centered personal health records with~     higher levels of functionality, combined with practice redesign to make use of these~     functions, can help patients obtain recommended cancer screening tests by linking them to~     their doctor's records, explaining information in lay language, displaying tailored~     recommendations and educational resources, providing logistical support and tools to~     stimulate action, and generating reminders. This project will measure whether making these~     resources available to primary care practices and patients promotes shared decision-making~     and increases the delivery of cancer screening compared to existing information systems.~   "
70204|NCT02138435|"~     Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If~     discovered in infancy or early childhood surgical intervention can be of necessity depending~     on the size of the defect, to assure a healthy adulthood. The long-term results of surgical~     closure of VSD in childhood are good and after surgery the children are considered as~     equally healthy and physically fit as their peers. However, there is inconsistency in data~     regarding follow-up on this group of patients, in relation to exercise capacity as a measure~     of the cardiopulmonary function. To further approach this matter the post-operative cardiac~     factors of these patients have to be investigated.~      With this study the investigators intend to examine the long-term outcome on cardiac output~     after heart surgery in VSD-patients. It presents an opportunity to also evaluate the~     correlation between cardiac output determined by gas-exchange and by MRI. The overall~     objectives of this study are to 1) examine whether VSD-operated patients have reduced~     cardiac output during exercise in comparison with matched controls, and furthermore 2) to~     evaluate a correlation between cardiac output measured by MRI and cardiac output determined~     by gas-exchange.~      The project is designed as a long-term follow-up and method study. A cohort of 20 children~     who in the 1990's underwent surgical closure of a congenital VSD will be asked to~     participate in this study. An equal amount of healthy young adults, will function as control~     group. Each participant will complete two different exercise tests, a MRI of the heart~     during lower body exercise on a supine ergometer bicycle, and a Supine ergometer bicycle~     exercise test. This data can be used for comparing cardiac output between the test groups,~     and furthermore it allows an evaluation of the correlation between the two methods.~      VSD is as described, the most common congenital heart anomaly. If not intervened with in~     childhood, it can cause severe heart complications later in life. It is unclear whether this~     intervention can cause long-term impact on patients exercise capacity, and for that reason~     it is of great importance that we strive for improving our knowledge of the long-term~     postsurgical outcome after VSD-closure.~   "
70205|NCT02138422|"~     The primary objective of this study will be to assess how effective Xilonix is in the~     treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps~     tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may~     improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with~     colorectal cancer. The effectiveness of the therapy will be measured by assessing the change~     in these symptoms for patients treated with Xilonix versus those treated with placebo.~     Reversal of muscle loss will be assessed with a type of X-ray called a DEXA scanner.~     Improvement in pain, appetite loss, and fatigue will be measured with a questionnaire that~     is completed by patients enrolled on the trial.~   "
70206|NCT02138409|"~     Participants will be selected from patients who have been scheduled at the site for~     treatment of chronic pain without sedation. They will receive either fentanyl sublingual~     spray or a matching placebo sublingual spray that delivers no medication.~      Participants may take pain killers at any time after the procedure for pain relief. They~     will be given a diary card, which they will take home. They will record the name of the~     medication taken, the time, and dosage.~      The study coordinator will call participants about 24 hours after the procedure to collect~     information from the diary card and follow up information about pain and side effects~     (adverse events) after they left the site.~   "
70207|NCT02138396|"~     The objective of this study is to compare the rate of absorption and bioavailability of~     fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.~   "
70208|NCT02138383|"~     The main purpose of this study is to find out the dose of enzalutamide that can be safely~     given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.~     Researchers also want to find out the side effects of these drugs when given together. This~     study will help in finding out the effect on tumor of the combination of enzalutamide,~     gemcitabine and nab-paclitaxel. In the first part of the study, different doses of~     enzalutamide will be tested. In the second part of the study, all patients will be started~     at the same dose of enzalutamide.~   "
70209|NCT02138370|"~     Surgery still remains the mainstay of treatment for localized colorectal cancer. However,~     nearly 30% of patients with localized colorectal cancer (stage II and stage III) will~     present with recurrence. Tumor progression is mediated by both intrinsic genetic changes and~     by extrinsic epigenetic and host environmental factors, including interactions with the~     immune system. Several studies demonstrated that tumor infiltrating memory T-cells and type,~     density and location of infiltrating T cells are better predictors of disease-free survival~     in patients with CRC compared to the standard TNM staging. These data suggest that tumor~     invasion and progression are more accurately predicted by immune response in the primary~     tumor. In addition, mismatch repair (MMR)-deficient tumors are characterized a priori by a~     higher frequency of tumor infiltrating lymphocytes and are associated with significantly~     improved prognosis. Recently, Stotz et al showed that the preoperative lymphocyte to~     monocyte ratio in peripheral blood samples predicts clinical outcome in patients with stage~     III colon cancer. So far there is no comprehensive analysis of the immune-landscape in CRC.~      The aim of the current project is to identify a comprehensive panel of immunomarkers in~     localized colorectal cancer (stage II and stage III) applicable for the detection of~     patients at high risk of recurrence. For the first time, specific tumor-infiltrating immune~     cells, mismatch repair protein expression in tumor tissue and preoperative blood based~     inflammatory markers from routine blood counts in corresponding peripheral blood samples and~     known clinicopathological features will be correlated with outcome in 300 localized CRC~     patients.~   "
70210|NCT02138357|"~     The primary objective of the study is to determine whether Butrans Transdermal System (BTDS)~     reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are~     naïve to opiate treatment.~      The secondary objective of the study is to investigate the effects of BTDS on mood, sleep,~     and quality of life.~      The study will consist of nine visits. Depending on the need for medication titration, there~     may also be two scheduled telephone contacts.~      Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who~     choose to participate must undergo medication washout as described in the detailed protocol~     between visits 1 and 2.~      Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and~     subjects randomized to treatment order at visit 2 (day 0). Study medication as well as~     rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose~     range as described in the detailed protocol) will be dispensed. Subjects will begin~     treatment period #1 immediately after this. The study medication will be titrated within the~     allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day~     14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of~     outcome measures for the first treatment period. Visit 5 will also mark the beginning of the~     second treatment period.~      Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those~     described above during treatment period #1. Visit 8 will mark the end of the second~     treatment period during which outcome measures will be ascertained.~      Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two~     weeks after visit 8 for review of adverse events.~   "
70211|NCT02138344|"~     Development of neuropathic pain is one of the most disabling sequels after spinal cord~     injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in~     humans as well as its plastic changes following SCI can be assessed in vivo by surface~     electrophysiological recordings and functional magnetic resonance imaging after noxious heat~     stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the~     pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve~     diseases in an objective manner, b) characterizing plastic changes in the pain pathway in~     SCI patients with neuropathic pain and in patients with peripheral nerve diseases and~     relating them to the development of neuropathic pain syndromes.~   "
70212|NCT02138331|"~     Type 1 diabetes mellitus is strictly autoimmune mediated disease destructing the islets~     β-cell of the pancreas. Mesenchymal stem cells and its microvesicles are reported as an~     anti-inflammatory agents. We hypothesis that intravenous infusion of cell free umbilical~     cord-blood derived MSC microvesicles may reduce the inflammatory state and hence improve the~     β-cell mass as well as the glycemic control of the patients of T1DM.~   "
70213|NCT02138318|"~     Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC)~     compared to the general population. Regular screening by colonoscopy is an internationally~     recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon~     has been the mainstay of conventional surveillance practice to detect abnormalities, known~     as dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and~     processed, a practice which is is tedious, expensive, time consuming and has a low pickup~     rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with~     standard conventional white light colonoscopy (WLC).~      Detection can be improved by the application of dyes which highlight more subtle~     abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia~     detection but more time consuming for the patient and cannot guarantee that the whole colon~     is covered. CE has only been compared in clinical trials with standard definition endoscopy~     rather than the recently available high definition endoscopes with better resolution and~     picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution~     CCD (charge coupled device) providing much better images than standard video endoscopy. HD~     colonoscopy promises therefore to provide an alternative to CE in UC surveillance without~     the need for the extra time and experience required for dye spraying for both endoscopists~     and nursing staff.~      The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to~     chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for~     ulcerative colitis. There have been no trials comparing these two modalities and the~     investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy~     would be marginal and therefore CE would be reserved for procedures using standard~     definition scopes.~   "
70245|NCT02137902|"~     This study aims to identify effective and cost-effective interventions for tobacco use and~     other risk behaviors for cardiovascular disease among Alaska Native people in rural~     villages. In a randomized controlled trial, the study will compare interventions using~     telemedicine to promote the American Heart Association's identified ideal health behaviors~     (nonsmoking and physical activity) relative to ideal health factors (managing cholesterol~     and blood pressure).~   "
70246|NCT02137889|"~     This study will assess the safety and preliminary efficacy of escalating doses of VAY736 in~     relapsed or refractory CLL patients.~   "
70214|NCT02138305|"~     Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is~     conventionally used to infer how likely the stenosis will limit blood flow (called ischemia)~     under conditions of increased demand (e.g exercise). This is based on animal work and data~     from humans with simple single vessel disease with no co-existing conditions. These data~     have been extrapolated to more complex patients/ complex disease but clearly over-simplifies~     the situation in the majority of patients cardiologists treat.~      Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure~     derived measurements, called FFR, from the coronary artery during a cardiac catheterization,~     more accurately identify stenoses that would cause ischemia compared to visual assessment~     alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly~     improved outcomes and reduced costs compared to visual assessment alone (FAME trial).~     Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent~     sensitivity and specificity. A FFR of <=0.80 was used as this identified ischemia causing~     lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation~     and treatment deferral has a robust evidence base to support it.~      Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of~     angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used~     by some cardiac surgeons to assess the patency of bypass grafts in real-time in the~     operating room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson~     observed that regional myocardial perfusion (RMP) image data was also captured in these~     video sequences.~      Study Hypotheses:~        1. In patients who are likely CABG candidates, target vessel epicardial coronary arteries~          (TVECAs) with FFR > 0.80 will not demonstrate an increase in RMP despite an~          anatomically patent bypass conduit during SPY® imaging.~        2. In TVECAs with an increase in RMP during SPY® imaging, cardiac catheter laboratory~          measures of coronary physiology from that TVECA, namely one or a combination of FFR,~          CFR, HSR and HMR, will correlate with the SPY® data on myocardial perfusion, and~          suggest a potential mechanism for this physiologic response to TVECA grafting.~   "
70215|NCT02138292|"~     The study is a prospective, single-arm, one-site therapeutic trial of the combination of~     trametinib plus digoxin for advanced melanoma. endpoints are toxicities assessed by nCi~     CTCae v4.1 within the first 8 weeks, responses measured by ReCiST v1.1 criteria every 8~     weeks with scans and exams, tumor sensitivity to the drug combination quantified by tumor~     regressions in nSG mice, and correlations of response with tumor sensitivity, BRaF status,~     MaPK inhibitor exposure history, and tumor sodium pump expression.~      Treatment Dosage and administration~      Study Drugs:~        1. Trametinib (2mg) will be administered orally on a daily basis.~        2. Digoxin (0.25mg) will be administered orally on a daily basis.~      on a 8-week cycle, duration of treatment can last from 8 to 104 weeks.~      endpoints~        1. Toxicities will be assessed via nCi's CTCae v4.1 toxicity criteria. DLTs will be~          defined based on the rate of drug-related (definitely or probably) grade 3-5 adverse~          events experienced within the first 8 weeks of study treatment. The MTD will be~          exceeded if more than 20% of patients on the study experience DLTs.~        2. Responses will be measured by ReCiST v1.1 every 8 weeks. Response duration will be~          defined as time from first documented response until disease progression. PFS is time~          from treatment until disease progression.~        3. Patient tumor sensitivity to the drug combination will be quantified by the amount of~          subcutaneous established tumor growth inhibition in nSG mice by 5d/week oral gavage~          with drugs.~        4. Tumor nRaS status will be determined by tumor Dna extraction, PCR amplification of~          exons and Sanger sequencing of nRaS.~        5. History of prior MaPK inhibitor therapies will document MeK inhibitor exposures.~        6. Sodium pump subunit expression will be analyzed by pretreatment tumor~          immunohistochemistry and a qualitative 0 to 3+ grading system.~   "
70216|NCT02138279|"~     The primary objective of this clinical study is to collect clinical data to support FDA~     510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The~     secondary objective is to evaluate any adverse events found during the clinical study.~   "
70217|NCT02138266|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
70218|NCT02138253|"~     This is a double-blind, multicenter study involving patients with chronic HCV infection who~     had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete~     cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but~     still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with~     IDN-6556 is better than placebo in reversing or stopping the progression of the damage to~     the new liver caused by HCV.~   "
70219|NCT02138240|"~     The 1.2 million households living in public housing are disproportionately affected by~     obesity, where prevalence is estimated at 50%. An ecologic framework hypothesizes that this~     disparity is related, in part, to social and environmental factors within these~     neighborhoods that influence residents' lifestyles. Social networks and the built~     environment may work together to promote or inhibit lifestyle behaviors; however, combined~     social network-built environment interventions have not previously targeted changes in diet.~     We hypothesize that an intervention that combines a social network approach with strategies~     that address public housing residents' challenges related to the built environment will~     improve dietary habits. Our overall aim is to develop a combined social network-built~     environment intervention to reduce intake of beverages high in added sugars and to pilot~     test the intervention among residents of public housing developments in Baltimore, MD. Our~     aim for this work is: 1) To develop a combined social network-built environment intervention~     to reduce intake of beverages high in added sugars and to pilot test the intervention among~     residents of public housing developments in Baltimore, MD. We hypothesize that a social~     network intervention will be feasible and acceptable in promoting healthy lifestyle change,~     and that this intervention will alter lifestyle behaviors among public housing residents.~   "
70220|NCT02138227|"~     The purpose of this study is to evaluate the efficacy and generalizability of a~     communication intervention (Communication Effectively about Donation (CEaD)) for Organ~     Procurement Organization (OPO) staff requesters and to compare two conditions of delivering~     the CEaD. The experimental design will test: (1) the overall efficacy of the intervention on~     timely referral and consent for organ donation and (2) whether a completely autonomous~     condition (no outside training assistance) is clinically equivalent to the assisted~     condition (training provided by outside consultants) in terms of the final outcome of~     consent to donation.~   "
70221|NCT02138214|"~     This randomized phase II trial studies how well thyroid gland removal with or without~     central lymph node dissection works in treating patients with thyroid cancer or suspected~     thyroid cancer that has not spread to the lymph nodes. Currently, the standard treatment for~     thyroid cancer is total thyroidectomy, or complete removal of the thyroid. Sometimes, the~     lymph nodes in the central part of the neck may also be surgically removed, called central~     lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of~     life-threatening complications, and may reduce post-surgery quality of life. It may also~     prevent the cancer from returning and reduce the need for additional surgery. It is not yet~     known whether recurrence rates and complication levels are lower after thyroid gland removal~     alone or with central lymph node dissection.~   "
70288|NCT02137343|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of~     Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced~     mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction~     adenocarcinoma (GEJ).~   "
70222|NCT02138201|"~     The exact innervation of the bladder and the changes after a spinal cord injury have been~     not yet been illustrated.~      Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be~     used to visualize single nerve fibers, and thus represent the neural supply of a region in~     vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been~     represented using diffusion tensor imaging. However, there is no study concerning the~     innervation of the bladder.~      The investigators are therefore using diffusion tensor imaging with magnetic resonance~     imaging to represent the bladder innervation of individuals with neurogenic lower urinary~     tract dysfunction and individuals with normal bladder function.~   "
70223|NCT02138188|"~     The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological~     distress and some psychological factors might be predictors of metabolic control; however,~     very few studies conducted so far were specifically focused on the psychological aspects of~     CSII therapy in adults affected by T1DM.~   "
70224|NCT02138175|"~     The purpose of the study is to determine whether noninvasive hemoglobin monitoring is~     sensitive and accurate enough to detect a significant downward trend in hemoglobin in~     patients at risk for significant bleeding. If this can be shown, it has the potential to~     spare patients multiple invasive blood draws as well as allow for earlier detection of~     significant blood loss and therefore positively impact on patient morbidity and mortality.~     Additionally, it may represent significant financial cost savings in that it may allow for~     patients to be monitored in a non-intensive care unit setting.~      This will be an observational study. The continuous hemoglobin monitor will be connected to~     the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin~     monitoring will occur concurrently at a pre-specified frequency as well as at the~     physician's discretion based on usual clinical information. The physician will be blinded to~     the continuous hemoglobin monitoring readings and therefore patient care will not be~     affected by the use of the monitor. Once the study has ended, the data will then be analyzed~     to assess for correlation between continuous hemoglobin monitoring readings and laboratory~     hemoglobin measurement.~   "
70225|NCT02138162|"~     The influence of severely diminished liver function on the metabolism, safety, and~     tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are~     compared to the data gained from 8 age- and BMI-matched men with normal liver function.~   "
70226|NCT02138149|"~     Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this~     bladder dysfunction, individuals with SCI have to undergo regular invasive examination of~     their bladder function (urodynamic examination).~      The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there~     are reports, that the concentration of NGF is elevated in the urine of patients with bladder~     dysfunction. The NGF concentration can also be measured in the blood. The concentration of~     NGF in the blood and urine of SCI individuals has not yet been investigated. These~     concentrations may correlate with the severity of bladder dysfunction, and may thus be used~     to replace or at least reduce the number of the more invasive urodynamic examinations.~      The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher~     compared to individuals with healthy bladder function will be tested.~   "
70227|NCT02138136|"~     A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18~     years diagnosed with Functional Constipation~   "
70228|NCT02138123|"~     In this study, the investigators introduce a surgical procedure called IOL-shell technique~     in the purpose of reduce complications of surgeries for dense cataract, and report a~     prospective randomized controlled study aiming at assessing efficacy and safety of the~     IOL-shell technique, which showed that the new procedure offered a safer way for hard~     cataract surgery over the conventional phacoemulsification procedure without compromise in~     efficacy.~   "
70229|NCT02138110|"~     -  To evaluate whether the Scaffold is safe and demonstrates probable benefit for the~          treatment of complete T2-T12/L1 spinal cord injury .~        -  This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate~          safety and probable benefit in support of future studies and an HDE application with~          subsequent approval.~   "
70230|NCT02138097|"~     This protocol is for a series of descriptive analyses conducted within a cohort of patients~     using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and~     non-insulin injected hypoglycemic medications between May 2011 and July 2012.~      Understanding 1) the existing utilization patterns for linagliptin, sitagliptin,~     saxagliptin, and other oral and non-insulin injected hypoglycemic agents and (2) the~     differences in utilization patterns between these agents will help with the design, analysis~     and interpretation of comparative effectiveness and safety studies of linagliptin, other~     DPP-4 inhibitors, and other agents.~      The study will provide an overview of existing utilization patterns for linagliptin, other~     dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic~     agents, in order to detect potential selective prescribing patterns that might lead to~     channeling bias.~   "
70231|NCT02138084|"~     The purpose of this study is to provide dosing recommendations for the coadministration of~     BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for~     prescribing information purposes~   "
70232|NCT02138071|"~     The purpose of the study is to determent whether there is a difference between two types of~     treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in~     terms of their sensation of how they have been helped and their treatments' outcomes~     measures. The study hypothesizes are: a) Based on the results of literature review which~     does not reveal a clear difference between group and individual treatments' outcomes for~     LBP, it is hypothesized that no difference will be found in treatment results for the two~     types of group treatments in the present study also, b) The assumption is that different~     distribution of therapeutic factors will be found in the two types of treatments~     (individual, group), C) Patients' sensation of how they have been helped will be connected~     to treatment results.~   "
70233|NCT02138058|"~     It is a double blind controlled study to test the hypothesis that Topiramate is more~     effective than placebo in the treatment of compulsive buying, during a period of 12 weeks~   "
70234|NCT02138045|"~     The purpose of this trial is to explore whether liraglutide has a long term effect on~     clinical symptoms and biomarkers in patients with diabetic neuropathy.~   "
70235|NCT02138032|"~     Message framing involves the presentation of choice alternatives, either in a positive or~     negative manner (Huber, Neale, & Northcraft, 1987; p.137). Positively framed health~     messages contain potential gains of participating/refraining in specific health behaviour.~     Alternatively, negatively framed health messages contain potential losses of~     participating/refraining in specific health behaviour (Verlhiac, Chappe, & Meyer, 2011). The~     primary aim and rationale of this study will be to investigate which type of framing has the~     greatest effect on intentions to quit smoking in patients with vascular arterial disease.~     The secondary aim is to investigate what other factors may have an effect on intention to~     quit and also what factors play a part in a patient's intention to quit smoking.~   "
70236|NCT02138019|"~     The fibrin sealants are prepared from fibrinogen, thrombin, and sometimes factor XIII that~     have been purified from human plasma. Tissucol Duo Quick (Baxter, Vienna, Austria) is a kind~     of fibrin sealants with popular use. It is a 2-component tissue adhesive that resembles~     natural fibrin formation. This glue has 2 components: fibrinogen (mixed with factor XIII and~     aprotinin) and thrombin-CaCl2 solution. When equal amounts of the 2 components are mixed,~     the monomers aggregate by cross-linking, resulting in a fibrin clot. It forms a elastic,~     whitish substance and provides strong adhesion to the tissue. Therefore, it is a good agent~     to seal small wounds or to replace the use of suture.~   "
70237|NCT02138006|"~     To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in~     type 1 diabetes patients former randomized to intensive insulin treatment~   "
70238|NCT02137993|"~     The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to~     Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective~     disorder.~   "
70239|NCT02137980|"~     This is a simple registry of patients undergoing PCI at hospitals without surgery on-site~     who were participants in the CPORT-E project. The aim of the registry is simple data~     collection and reporting to respective State Departments of Health. The registry population~     consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at~     hospitals without SOS and who require PCI.~   "
70240|NCT02137967|"~     Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in~     the primary teeth. However, concerns have been raised over the use of FC because of its~     toxicity and potential carcinogenicity. A substitution for FC has been investigated but~     evidence is lacking to conclude which is the most appropriate technique for pulpotomies in~     primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more~     than 80 years, and it is at present the most popular irrigant in root canal treatment.~     Studies have showed that NaOCl is biological compatible and is a very good antimicrobial~     solution without being a pulpal irritant. Recent studies using sodium hypochlorite as~     pulpotomy medicament in primary molars showed promising results. In this project, the~     investigators propose a randomized clinical trial, which will be performed in Pediatric~     Dentistry Department of the National Taiwan University Hospital, to compare the treatment~     outcomes between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim~     of this sudy is to determining weather NaOCl is a suitable replacement for FC in the~     pulpotomy of human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to~     9 year-old, who have at least one primary first or second molars diagnosed to receive~     pulpotomy treatment will be recruited in this project. The involved teeth will be randomly~     assigned to the control group (dilute 20% Formocresol (DFC)) or experimental group (2.5%~     NaOCl). At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth~     will be clinically and radiographically evaluated by blinded independent evaluators to the~     treatment group. The differences will be statistically analyzed using chi-square test,~     Fisher exact test, and t-test, using a statistical significance at p<0.05.~   "
70241|NCT02137954|"~     This is a multicenter, prospective, randomized, placebo-controlled, double-blind,~     two-parallel groups study comparing lidocaine (experimental group) to placebo (control~     group). The study protocol was elaborated using the recommendations of the Consolidated~     Standards of Reporting Trials (CONSORT) Statement.~   "
70242|NCT02137941|"~     Chronic stress at work is a public health problem increasing morbidity and mortality,~     especially in men. Among the men military populations, the firefighters of Paris (FFPs) are~     particularly exposed. To deal with this stress and to improve stress management is~     challenging. Psychological fitness is required to regulate emotions which improve~     effectiveness under stress and enhance recovery from stressful events. The heart coherence~     (HC) program uses feedback from a simple pulse sensor to reflect changes of the~     emotional/psychological state, and to learn how to reduce stress and stabilize emotions.~     Another kind of psychological fitness focuses on cognitive training to regulate emotions,~     with the use of techniques to optimize potential (TOP). The TOP consists of learning easy~     techniques in mental skills to improve cognitive-based problem-solving using respiration,~     relaxation, and visualization. Although never published in a peer-review journal, the~     procedure of TOP training is structured and standardized for individuals and groups, and is~     widely practiced in air traffic controllers, with apparently good effects.~      Moreover, any event can be emotionally ambiguous, providing both negative and positive~     outcomes. The interpretation of such ambiguity is linked with an individual's emotional~     state, such as anxiety or mood. Individuals with a high level of trait anxiety are likely to~     interpret an event negatively.~      However, no studies have compared the effect of HC or TOP in the perceived stress of FFPs.~     Nor have long-term effects of these stress management programs (SMP) been investigated.~     Furthermore, the influence of trait anxiety on stress levels in FFPs needs to be clarified.~     Finally, no trials have assessed levels of biomarkers stress following these SMP.~      From these observations, we hypothesized that 1) young recruits aiming to become FFPs will~     be particularly exposed to stress, 2) SMP will be effective in reducing perceived stress, 3)~     SMP will mainly benefit FFPs who have high anxiety, and 4) the effects of SMP will lower~     levels of biomarkers of stress.~      The aim of this randomized control trial is to evaluate the effectiveness of stress~     management programs on perceived stress (primary outcome variable), and on negative mood,~     mindfulness, and biomarkers of stress (secondary outcome variables) in FFPs. We also aim to~     investigate the influence of anxiety on the stress management programs effectiveness~     long-term.~   "
70243|NCT02137928|"~     This study will evaluate the clinical efficacy of periocular injections of carboplatin~     together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy~     alone.~   "
70244|NCT02137915|"~     This study is being done to determine the long-term safety and possible benefits of~     transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic~     Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to~     those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part~     of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term~     follow-up study.~   "
70715|NCT02131740|"~     This study addresses the research question:~      How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers~      The study objectives are:~        1. To determine the corneal changes following eye rubbing~        2. To assess tear film changes following eye rubbing~        3. To investigate if there is an association between eye rubbing and axial length of the~          eye.~   "
70247|NCT02137876|"~     This study is being done to better understand how immunosuppressive medications~     (anti-rejection medications that may or may not be approved by the Food and Drug~     Administration (FDA)) affect the alloimmune response (how a person's immune system reacts~     against another person's immune system). This will be determined by the blood tests run on~     the patients donated blood cells.~      Specifically, the investigators will test different immunosuppression medications using~     in-vitro assays (in the laboratory, in test tubes) alone and/or in combination to test how~     they can affect B-cell proliferation and differentiation, leading to an altered distribution~     among defined B-cell subsets and to study if exposure of B cells to thymoglobulin can have~     effects on subsequent interaction between B and T cell in vitro.~      To enable the investigators to understand how immunosuppressant medications affect immune~     systems in transplant patients, the investigators need to understand how they affect immune~     systems in healthy people. To do this, the investigators will need to study blood collected~     from healthy volunteers.~   "
70248|NCT02137863|"~     The aim of this study was to evaluate the effects of dexmedetomidine on renal function,~     hormonal and hemodynamic parameters in contrast media induced diabetic patients.~   "
70249|NCT02137850|"~     This trial is conducted globally. The aim of the trial is to investigate the safety and~     efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with~     haemophilia A.~   "
70250|NCT02137837|"~     This randomized Phase III trial studies how well the combination of fulvestrant and~     everolimus together or the combination of anastrozole, fulvestrant and everolimus together,~     improve progression-free survival (PFS) versus fulvestrant alone.~   "
70251|NCT02137824|"~     The aim of the present study is to establish a modified minimally invasive surgical~     technique for sinus floor augmentation with a residual bone height of 3-6mm.~      Hypothesis: The investigators expect that the present surgical technique allows to achieve~     an adequate implant bed of at least 10mm height after a healing period of 3-5 months.~     Further the modification of the technique enables a reduced patient stress level.~   "
70252|NCT02137811|"~     Recently an automated test for measuring cancer cell death in the presence of chemotherapy~     has been developed. This test has been called the MiCK assay during the ten year development~     phase and is now called Correct Chemo.~      CorrectChemo provides the medical community and patients a way to determine the effects of~     different chemotherapies on individual cancer cells.~      MiCK assay has been proven to have clinical usefulness in two studies. In one study using~     multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the~     physician used the results to prescribe the chemotherapy treatment, the patients' response~     rate, time to the disease getting worse, and overall survival were all significantly better~     compared to patients whose physicians did not use the results. In another study of breast~     cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used~     when planning chemotherapy, response rate and time to the disease started getting worse were~     all significantly better compared to patients whose physicians did not use the results of~     the MiCK assay The purpose of this study is to compare the outcomes of patients who have had~     the MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and~     how the physicians used the test. This study will be gathering this data by reviewing~     medical charts.~   "
70253|NCT02137798|"~     To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation~     in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated~     3-dimentional electroanatomical mapping system, comparing to using 3-dimentional~     electroanatomical mapping system without fluoroscopy image integration~   "
70254|NCT02137785|"~     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and~     effective in the treatment of actinic keratoses on the upper arms and hands~   "
70255|NCT02137772|"~     The study will evaluate the efficacy and safety of MK-8228 for the prevention of~     clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic~     hematopoietic stem cell transplant. The hypothesis being tested is that MK-8228 is superior~     to placebo in the prevention of clinically-significant CMV infection through 24 weeks after~     transplant.~   "
70256|NCT02137759|"~     In the first phase of this study (Cohort 1), the investigators will determine the~     feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with~     standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can~     predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a~     and 2b), the investigators will find the maximum tolerated dose of belinostat for treating~     newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid~     clinicians in the early determination of response to this new therapy.~   "
70257|NCT02137746|"~     The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in~     patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an~     objective progression of the disease.~   "
70258|NCT02137733|"~     The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol~     by evaluating tolerability (The probability that administered maintenance dose reaches the~     maximum will be determined as an indicator) as a primary endpoint when bisoprolol or~     carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In~     addition, the safety and efficacy of bisoprolol will be investigated.~   "
70259|NCT02137720|"~     The goal of this study is to evaluate the implementation and effectiveness of an~     intervention to improve diabetes self-management, emotional distress and metabolic control~     among adults with type 2 diabetes receiving care in primary care practices throughout New~     York City. The program will be implemented by the New York City Department of Health,~     through their Primary Care Improvement Project.~   "
70260|NCT02137707|"~     This study will determine whether in RRMS patients receiving Gilenya there is a link between~     disease progression and biologic markers.~   "
70485|NCT02134769|"~     Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon.~     However, there are no studies describing a positive effect of using Bionecteurs ® in regard~     to catheter-related bloodstream infections. In this study Bionecteur® will be used on~     central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The~     incidence of catheter-related bloodstream infections will we compared to patients without~     inclusion of Bionecteur® devices.~   "
70261|NCT02137694|"~     Auto-takings by APU and vaginal APV during the consultations for FCU in the department of~     gynecology-obstetrics (Group 1) according to an instructions for use proposed to the~     inclusive women, with consent; the same proposal, APU and APV, is made for other~     consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology,~     ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the~     laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results~     transmitted to the women and to the doctors of consultation. In case of positive test (15~     %), the patients are directed to a gynecologist. Confrontation with the cytological data~     when available (Group 1) .~   "
70262|NCT02137681|"~     The project was undertaking by Qilu Hospital, Shandong University and other several~     well-known hospitals in China. In order to report the efficacy and safety of Rituximab in~     different frequencies for the treatment of adults with steroid-resistant/relapsed immune~     thrombocytopenia (ITP).~   "
70263|NCT02137668|"~     The purpose of this study is twofold. First, is to determine whether vancomycin is effective~     in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and~     if so, by what mechanism. Secondly, to characterize human intestinal microbial communities~     and their interactions with the host.~   "
70264|NCT02137655|"~     The development and implementation of fast-track principles in total knee and hip~     arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length~     of hospital stay. This without a concomitant increase in morbidity or readmissions for~     medical or surgical complications and with reduced mortality. However, only little is known~     about function in the subacute period after arthroplasty, and there is a need for further~     data on physical and psychological functioning following discharge from hospital.This to~     ensure, that the positive results from the perioperative setting are carried forward in the~     subacute phase.~   "
70265|NCT02137642|"~     The purpose of this study is to evaluate safety and tolerability as well as the effects of~     RM-131 on colonic motor and sensory effects in patients with chronic constipation.~   "
70266|NCT02137629|"~     The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety~     information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved~     package insert, after approval of marketing authorization for new drug in Korea. In~     addition, the efficacy information of VIDAZA® in clinical practice is collected and~     evaluated. This DUE is a prospective, multi-centre, observational, non-interventional,~     post-marketing surveillance. At least 600 patients' data that is eligible for safety~     assessment will be collected.~      VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)~      /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug~     Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors~     influencing safety & efficacy of the drug. It is necessary to examine patients' demographics~     and baseline characteristics, medical history, status of VIDAZA treatment, concomitant~     medication and evaluation of safety and final efficacy (best response) assessment.~   "
70267|NCT02137616|"~     This study assess the safety and effects of atypical antipsychotics in subjects with~     psychosis syndrome and psychosis risk syndrome.~   "
70268|NCT02137603|"~     The literature has reported that fast track surgery can be safely applied to children~     undergoing appendectomy for acute appendicitis. There is no current evidence regarding the~     application of same day discharge protocol in children with intra-operative findings of~     suppurative appendicitis. The current standard of care for patients who present with~     intra-operative findings of suppurative appendicitis includes post-operative admission and~     treatment with intravenous antibiotics. Patients are discharged home once they have met the~     following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with~     oral pain medication, and tolerating a liquid diet. Given the evidence in the literature~     that has shown that same day discharge of patients with acute appendicitis is safe and~     effective, we propose that fast track surgery protocol can be safely applied to patients~     with intraoperative findings of suppurative appendicitis. We hypothesize that this will~     result in a decreased postoperative length of stay, without an increase in 30-day~     complication rate.~   "
70269|NCT02137590|"~     This study will investigate the effect of Spanish Black Radish on phase I and phase II~     enzyme activity in healthy adult males. The primary objective is to determine the effect on~     phase I and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite~     concentrations prior to and after a 28 day supplementation period with Spanish black radish~     product.~   "
70270|NCT02137577|"~     The purpose of this study is to determine whether DEB is more effective than common PTA~     balloon using under in long-term vessel patency and inhibiting restenosis in the~     infrapopliteal artery.~   "
70271|NCT02137564|"~     This phase II trial studies the effects, good and bad, of gamma secretase inhibitor~     PF-03084014 and to see how well it works in treating patients with acquired immune~     deficiency virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and~     may shrink the tumor.~   "
70272|NCT02137551|"~     The primary objective of the study is to evaluate how engaging ACO beneficiaries in the~     appointment based model for one year impacts medication adherence and healthcare costs~     compared to usual care.~   "
70273|NCT02137538|"~     The purpose of the study is to determine if there are differences in the final height or~     hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now~     routinely used to increase stature: Anastrozole and Letrozole. It also should determine if~     there are differences in the side effect profiles of the two drugs to be used.~   "
70274|NCT02137525|"~     This study will explore effectiveness of three doses of fentanyl sublingual spray against an~     active comparator in emergency department (ED) patients with acute pain.~      After screening, eligible participants will participate in a treatment period (up to 2~     hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED).~     Open-label standard of care rescue medication for pain can be given at any time during the~     study period, based on clinical judgment of the treating physician.~      Adverse events will be collected for five days after initial enrollment.~   "
70486|NCT02134756|"~     Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day~     intervention on aerobic exercise performance and fatigue.~      The hypothesis is that supplementation with NutraStem Active® improve aerobic performance~     and reduce subjective measures of fatigue.~   "
70275|NCT02137512|"~     The purpose of this study is to see if an automated insulin management system (study~     system) can safely be used at home to manage blood sugar. The study system includes (1) a~     CGM that measures glucose levels, (2) a computer program on a smartphone that determines how~     much insulin is needed and allows the study participant user to control the whole system,~     and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump~     will be from Roche. The CGM and pump are similar to the devices that are currently available~     for people to purchase and use. However, the smartphone device, the CGM sensor type used~     with it, and the overall study system can only be used for research at this time.~      The study will be completed by about 24 individuals at 6 centers in the United States and~     Europe. This study has several phases and will take about 11-14 weeks to complete depending~     on whether the study participant is a CGM user or not.~      At selected sites (based on subject eligibility and availability), approximately 10-20~     subjects who exhibit safe and competent use of the system at home will be given the option~     to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.~   "
70276|NCT02137499|"~     The investigators will be evaluating the immediate and longer term effect of treatment with~     a medical device on the symptoms of chronic venous disease.~   "
70277|NCT02137486|"~     Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis.~     Their structural properties make angioplasty technique to increase the difficulty of~     implementation, but also increased the risks of the in-stent thrombosis and restenosis.~     Standard treatment of coronary bifurcation lesions remains controversial manner, especially~     when the side branch (SB) was large combined with high angulated bifurcation lesions.~     Complex procedures and certain types of lesions are associated with poor prognosis. There is~     no standard treatment for such lesions even with the development of drug-eluting stents~     solve partial problems. The investigators reviewed patients who received coronary~     intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the~     prognostic relevance of these cases the use of different treatment modalities .~   "
70278|NCT02137473|"~     Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal~     nutrient reserves and elevated nutritional requirements which may contribute to poor~     outcome. Adding nutrients to human milk improves their nutritional status and growth, but it~     is unclear if adding bovine protein-based fortifiers as is the current standard of care has~     some unintended negative consequences to neonates. Infants will be randomized to have their~     feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human~     milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to~     assess feeding tolerance, growth, gut inflammation, gut microbiome, and neonatal morbidity~     and mortality.~   "
70279|NCT02137460|"~     This is a prospective cohort study for cognitively normal (young and old), mild cognitive~     impairment, and Alzheimer's disease people~   "
70280|NCT02137447|"~     The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in~     high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).~      Hypothesis:~      Historically, the average rates of infective complications in surgical wounds types are 7.7%~     in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of~     Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to~     reduce these rates by 50%.~   "
70281|NCT02137434|"~     The purpose of the study is to investigate calcium acute influence over the postprandial~     effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure,~     oxidative stress, and endothelial function in obese women.~   "
70282|NCT02137421|"~     The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O~     (FOXO) pathways by means of investigating their target genes in coronary artery disease~     (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD~     patients.~   "
70283|NCT02137408|"~     The Investigator would like to see if taking a DHA supplement at a dose recommended for~     heart health will improve brachial artery dilation (relaxation) and help blood pressure. As~     a second goal the Investigator would like to see if this supplement can delay preterm~     delivery by improving heart health. In this research study, the Investigator is asking~     pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences,~     now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks~     after they deliver their baby.~   "
70284|NCT02137395|"~     The purpose of this study is to determine whether dexamethasone extends the duration of~     recovery from anesthesia.~   "
70285|NCT02137382|"~     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion~     of fat, sugars and proteins) in Cystic Fibrosis~   "
70286|NCT02137369|"~     While there are many effective options for treating a major depressive episode, there are no~     clinical markers that predict the likelihood of remission with an initial trial of either an~     antidepressant medication or psychotherapy. The goal of this study is to test how brain~     function changes in depress patients treated with cognitive behavioral therapy (CBT)~     compared to patients treated with escitalopram ((s-CIT) - Lexapro®), an FDA approved~     antidepressant. The study aims to determine if bran scan findings might help physicians to~     select the most effective antidepressant treatment for an individual patient.~      At total of 150 male and female outpatients who are between 21-55 years old will be~     enrolled. Participation in the study will last from 14-26 weeks.~      Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks.~     Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance~     imaging (fMRI) scans will be done before the treatment begins, and again at the end of~     treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an~     additional 12 weeks of treatment with the alternative intervention.~   "
70287|NCT02137356|"~     Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally~     treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This~     treatment is associated with only a 15-20% pathological complete response. Selinexor~     (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has~     demonstrated radiosensitization with in vivo models and has suggested single agent activity~     against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of~     standard chemoradiation combined with Selinexor.~      We hypothesize that tumors treated with this new combination will demonstrate an increased~     response rate compared to those treated with capecitabine-radiation alone.~   "
70289|NCT02137330|"~     The ongoing global rise in the prevalence of overweight and obesity among all ages and among~     all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher~     incidence in serious health risks, already present at an early age, switching-on the~     engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the~     only way to avoid systemic and cardiovascular complications of obesity.~      Weight loss devices have been recently introduced in bariatric surgery, also in children.~     They mostly require invasive procedures to be applied. Mini-invasive devices would be needed~     to obtain weight loss in the pediatric population, since the early age of involved patients.~      Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air,~     and have been used to induce weight loss in obese adults. The investigators aimed to perform~     a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular~     parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.~   "
70290|NCT02137317|"~     According to the World Health Organization pesticide poisoning is a major health problem due~     to the millions of cases annually occurring worldwide. Farmers have a particularly high risk~     of pesticide poisoning because of their work involving pesticide use to protect crops. The~     majority of pesticide poisonings occur in developing countries. On a short term it is not~     realistic to reduce farmers' use of pesticides significantly because it would require that~     secure and cost-effective alternatives are introduced. This is a lengthy process, which~     should undoubtedly be supported. However, it becomes as important to make sure that farmers~     can protect themselves from pesticide exposure meanwhile. Use of personal protective~     equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their~     risk of pesticide poisoning. However, the sparse research identified through a systematic~     literature review shows that we are not in a position to give recommendations on what~     personal protective equipment farmers should protect themselves with against pesticide~     exposure suitable to their specific conditions. The purpose of the present study is to~     examine factors that influence farmers' use of personal protective equipment during their~     work with organophosphates and, based on this examine the ability of locally adapted~     personal protective equipment to reduce their organophosphate exposure. The hypothesis is~     that farmers working in locally adapted personal protective equipment have less acute~     organophosphate poisoning symptoms, a higher plasma cholinesterase level and find it to be a~     more feasible solution than farmers working in their daily practice wearing. Examining how~     locally adapted personal protective equipment (onwards referred to as the LAPPE solution)~     performs in practice implies testing it in an intervention study. A randomized crossover~     experiment design is chosen partly because fewer farmers have to be recruited since each~     farmer will act as his own control and partly because the between farmer variation is~     strongly reduced. The performance of the LAPPE solution will be tested in one experiment and~     compared to the performance of the same farmers' daily practice wearing (onwards referred to~     as the DP solution) in another experiment. The LAPPE solution is expected to have a superior~     performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study~     will be conducted among farmers in Chitwan, Nepal.~   "
70291|NCT02137304|"~     The investigators want to demonstrate that there is an optimal expiratory pressure when~     using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise~     is between the need to generate a high pressure difference between alveoli and the mouth and~     the need to avoide and superior airways collapsus.~   "
70292|NCT02137291|"~     Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used:~     the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by~     the majority of anesthesiologists for both left and right thoracic surgeries. Standard~     right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and~     that there is a risk of misalignment between the lateral orifice of the tube and the origin~     of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results~     suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more~     frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to~     reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group.~     The data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to~     facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend~     to provide quicker and better quality of lung collapse than BB. In 2013, investigators have~     demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two~     apnea periods when initiating OLV. Complementary analysis showed a significative difference~     to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right~     thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when~     using L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung~     will be slower and of poorer quality compare to the use of the Rm-DLT. The primary objective~     is to compare the delay between pleural opening (PO) and CLC in left VATS when using three~     lung isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate~     quality of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3)~     to evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device~     used and 5) to measure the delay between OLV and PO for evaluating the role of absorption~     atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a~     study of 40 patients undergoing an elective left VATS at IUCPQ involving one lung~     ventilation. They will have to be 21 years or more, to read, understand and sign an informed~     consent at their pre-operative evaluation. This study will be prospective, randomized, and~     blind to thoracic surgeons.~   "
70293|NCT02137278|"~     Investigate clinical effects (reduction of number of syncope and associate symptoms) of~     suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.~   "
70294|NCT02137265|"~     Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could~     improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.~   "
70295|NCT02137252|"~     Naltrexone is a drug which blocks some effects of chemicals called beta-endorphins that are~     made in the body. Beta-endorphins can be made in response to stress, injury, and also~     pleasurable activities. In previous studies, it has been shown that levels of~     beta-endorphins in the blood go up during radiation therapy, and that this increase is~     linked to fatigue. This suggests that naltrexone may help to reduce fatigue in people who~     are getting radiation therapy In this research study, the investigators are looking to see~     whether naltrexone works better than a placebo in reducing fatigue during radiation therapy.~   "
70296|NCT02137239|"~     Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress~     the immune system (called immunosuppressive regimens) to stop the immune system from~     attacking the transplanted kidney in order to limit damage to or the possibility of~     rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and~     risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with~     mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid~     withdrawal.~   "
70297|NCT02137226|"~     Primary Objective:~      The primary objective of this trial is to establish an equivalence in efficacy between BI~     695501 and US-licensed Humira® in patients with active RA based on a statistical comparison~     of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response~     rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed~     Humira®.~      Secondary Objectives:~      The secondary objectives of this trial are to compare the efficacy, safety and~     immunogenicity of BI 695501 and US-lisensed Humira® in patients with active RA including~     those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.~   "
70487|NCT02134743|"~     The aim of this study is to compare the stability of dental implant surface treated by~     sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces~     dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks~     after installation. The evaluation will be made by analyzing the resonance frequency~     (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show~     increased secondary stability prior to the implants treated by acid etching.~   "
70298|NCT02137213|"~     At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from~     constipation that often affects effectiveness of MMT and increases its impact on health care~     system. Existing treatments include several over-the-counter medications which do not target~     the pathobiological basis of opioid-induced constipation and have limited effectiveness. At~     the same time well-known medication, naloxone, was already shown to help with constipation~     in patients receiving methadone for chronic pain, but was never tried in patients receiving~     methadone for opioid dependence. This study is aimed to try naloxone for treatment of~     opioid-induced constipation in MMT settings.~      The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced~     constipation. The study has a crossover design - all patients will receive one week of their~     regular methadone doses and one week of their regular methadone doses with naloxone added.~     Normal saline will be added to methadone-only formulations as placebo. Order of the weeks~     will be chosen randomly. Both subjects and investigators will be blinded to the study~     condition (i.e. whether naloxone or normal saline is added to methadone preparation on a~     given week).~      Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1~     will have less severe symptoms of constipation compared to those receiving methadone only.~      Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause~     clinically significant opioid withdrawal symptoms.~   "
70299|NCT02137200|"~     The investigators propose a large, multicenter, randomized clinical trial of immediate~     versus delayed pushing for nulliparous women in labor at term reaching complete cervical~     dilation. The central hypothesis is that immediate pushing in the second stage of labor~     increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces~     adverse neonatal and maternal outcomes in nulliparous women. They will pursue the following~     specific aims: 1) Assess the effectiveness of immediate pushing at complete cervical~     dilation on the rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2)~     Determine the effect of immediate pushing on the rate of neonatal composite morbidity~     (Secondary Aim #1), and 3) Determine the impact of immediate versus delayed pushing on~     objective and subjective measures of maternal pelvic floor morbidity (Secondary Aim #2).~     They estimate that randomizing a total of 3184 women will provide adequate statistical power~     to detect meaningful differences in the primary and secondary outcomes.~   "
70300|NCT02137187|"~     There is evidence of superiority of AV junction ablation strategy over pharmacological~     therapy only for symptoms of atrial fibrillation, but not for heart failure,~     hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation~     is superior to pharmacological therapy as regard hospitalization and mortality~   "
70301|NCT02137174|"~     Home and school visits by multidisciplinary team will improve metabolic control in kids~     having insulin dependent diabetes mellitus~   "
70302|NCT02137161|"~     OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing~     postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract~     surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin~     0.3% ophthalmic solution).~      DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical~     trial.~      PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned,~     according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n~     = 31).~      INTERVENTION Cataract surgery by means of phacoemulsification and implantation of~     posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.~      Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given~     starting the day after the surgery for two weeks, dosed QID for the first week and BID for~     the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).~      Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after~     surgery. Standard post-operative topical antibiotic and steroid will be also given~     concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1%~     and tobramycin 0.3% eye drops association).~      Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks~     from cataract extraction.~   "
70303|NCT02137148|"~     The goals of this study are as follows; evaluation of the products' readiness to market,~     ascertain initial reactions by target users, evaluate actual use in potential clinical~     settings and any difficulties encountered with product use and actual venous cannulation.~   "
70304|NCT02137135|"~     Fluctuations of female sex hormones during the menstrual cycle influence pain perception.~     Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The~     investigators tested the primary hypothesis that the women having surgery during their~     follicular phase have more acute pain and require more opioids than those in the luteal~     phase, and secondarily the investigators tested that women who have surgery during their~     follicular phase have more incisional pain at 3 month postoperatively.~   "
70305|NCT02137122|"~     This study will investigate whether transcranial direct current stimulation enhances the~     effects of cognitive training in healthy older adults.~   "
70306|NCT02137109|"~     The primary objective of the study is to evaluate the safety of natalizumab use in the~     pediatric multiple sclerosis (MS) population.~   "
70307|NCT02137096|"~     This is a pilot study to evaluate the response rates for patients undergoing high dose~     conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous~     stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in~     children, adolescents, and young adults.~   "
70308|NCT02137083|"~     Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast~     Cancer~   "
70309|NCT02137070|"~     This study is being done to learn about the changes that weight loss causes on brain~     function, memory and thinking ability in adults.~   "
70310|NCT02137057|"~     Cardiac autonomic neuropathy is a common complication of diabetes and is associated with~     resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by~     central sympathetic blockade. The investigators evaluate the relation of severity of~     diabetes and heart rate variability, also the impact of spinal anesthesia on the change of~     heart rate variability.~   "
70311|NCT02137044|"~     The purpose of this study is to: (1) test the benefits of the patient-centered collaborative~     care treatment approach for persons with MS who also have depression and/or pain; and also~     (2) test whether this approach improves quality of life, patient satisfaction, adherence to~     other treatments, and quality of care in the MS care system.~   "
70312|NCT02137031|"~     The primary purpose of this pilot randomized controlled trial is to provide preliminary~     indicators of the effects of continuous subcutaneous insulin infusion with continuous~     glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic~     control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an~     estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to~     determine participants' satisfaction with allocated treatment.~      With increased and immediate information related to current and future (trend) glucose~     information provided by the continuous glucose monitor, children can then act upon this~     knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose~     variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c~     levels.~      Research on the effectiveness of continuous glucose monitoring on metabolic control in~     children with T1D using continuous subcutaneous insulin infusion has been limited.~     Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the~     feasibility and acceptability of continuous glucose monitoring on metabolic control and~     address the following objectives.~   "
70313|NCT02137018|"~     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new~     fixing method for prosthetic materials in the treatment of abdominal wall hernias,~     diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster~     in laparotomy procedure and laparoscopic procedures. Experimentation on breed pig Lantrace~     ANIMAL MODEL.~   "
70314|NCT02137005|"~     The purpose of this study is to investigate longitudinally, the walking ability of~     individuals with cerebral palsy who are transitioning into adulthood and to~     cross-sectionally examine the health status of these individuals in the context of their~     walking ability. Young adults who received instrumented gait analysis (IGA) as children will~     show significant decreases in overall gait performance, as measured by kinematics, kinetics,~     temporal-spatial parameters, and gait deviation index, compared to their last childhood IGA.~   "
70315|NCT02136992|"~     Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti-~     fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and~     safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of~     pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of~     a large sample of clinical cases.~   "
70316|NCT02136979|"~     CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate~     immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction~     during cardiac surgery, and induce immunosuppression. In recent previous studies, CD39 and~     CD73 was known to have important role in cancer patients for inducing immunosuppressive~     reaction and consequently induce cancer cell proliferation. However, the immunosuppressive~     effect of CD39 and CD73 during CPB time was not evaluated in previous studies.~      The authors hypothesized that CD39 and CD73 would have important role in CPB induced~     immunosuppression. Therefore, the present study determined the effect of CD39 and CD73~     during CPB.~   "
70317|NCT02136966|"~     Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact~     evaluation Hypothesis: The fortification of complementary foods associated with a counseling~     on feeding practices for infants and young children prevents malnutrition in 6-23 months-old~     children.~      Objective: to assess the effectiveness of a promotional care package in preventing~     malnutrition among children aged 6-23 months.~   "
70318|NCT02136953|"~     Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting~     2% of the population. Cognitive behavioural therapy (CBT) is considered first line~     psychological treatment for OCD, but there are a large number of treatment non-responders,~     and the majority of responders have residual symptoms. Aerobic exercise has shown potential~     benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This~     study will examine the additive benefits of a standard 12-week aerobic exercise program to a~     standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT~     results in significantly better clinical outcomes compared to either treatment alone or no~     treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive~     measures of clinical improvement.~   "
70319|NCT02136940|"~     The objective of this parallel group study is to evaluate the safety, tolerability and~     efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle~     glaucoma or ocular hypertension.~   "
70320|NCT02136927|"~     Pharmacokinetic, bioequivalence study~   "
70321|NCT02136914|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an~     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment~     of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel~     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the~     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in~     the evening, potentially reducing the negative impact of amantadine on sleep. This~     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER~     formulation than can be tolerated with an immediate-release formulation. The once-nightly~     dosing regimen may also provide enhanced convenience and compliance.~      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly~     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.~   "
70322|NCT02136901|"~     The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized,~     interventional clinical trial to test the hypothesis that the NUsurface implant is superior~     to the non-surgical standard of care in treating the target population.The rationale for~     performing this clinical study is to gather clinical data to evaluate the safety and~     effectiveness of the NUsurface device compared to the Standard of Care.~   "
70323|NCT02136888|"~     The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma~     exposures to ponesimod do not have an effect on cardiac repolarization exceeding the~     threshold of regulatory concern as measured by the QTc (interval from beginning of the Q~     wave until end of the T wave corrected for heart rate) interval duration after~     administration of multiple oral doses of 40 mg and 100 mg to healthy male and female~     subjects.~   "
84353|NCT01953276|"~     Our research will examine whether the presence or absence of serial electrocardiogram (ECG)~     changes aids in reclassifying participants' risk for major adverse cardiac events (MACE)~     over and above serial blood testing.~   "
70324|NCT02136875|"~     The purpose of this pilot study is to determine whether early treatment of acute~     exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy,~     Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known~     as the conventional treatment.~      Primary objective: To determine whether early treatment with combination therapy (SFP) can~     reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.~      Secondary objectives:~        -  To evaluate the feasibility of this treatment approach and to provide pilot data~          (needed for a larger multi-centre clinical trial;~        -  To evaluate the feasibility and need of assessment during and after exacerbation onset,~          health-related quality of life and physical activity;~        -  To evaluate the safety of this approach; this is in terms of the delay in starting~          prednisone and an unfavourable outcome (ER visits and/or hospitalization).~   "
70325|NCT02136862|"~     There is limited published clinical data about the natural history of renal disease in~     Alport syndrome. The RG012-01 study will collect data to characterize the progression of~     renal dysfunction in Alport syndrome patients.~      Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be~     considered for enrollment. The sequential sampling of subjects' urine and/or blood will~     allow an assessment of the rate of change of established clinical endpoints, such as GFR~     and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in~     subjects whose renal function is steadily declining. The identification of surrogate markers~     that track the decline of renal function and could correlate with time to end-stage renal~     disease (ESRD) is a key goal of the natural history study.~   "
70326|NCT02136849|"~     Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to~     4000 new cases each year. Chromosomal or molecular pathology causes are not identified in~     half of the cases by current techniques. Studies show that de novo mutations are common in~     many different genes. The exome approach by high-throughput sequencing (NGS) has emerged~     as the technique of choice for identifying and comparing the exome of the child to the~     parent. We wish to evaluate this approach and its contribution in the diagnostic management~     of 50 patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA /~     Biogenouest will provide technological and bioinformatics support this project.~   "
70327|NCT02136836|"~     The objective of this study is to investigate the proportion of HER2 overexpression in~     gastric cancer patients group, to evaluate the relation of HER2 overexpression with~     prognosis, and to analyze the proportion of herceptin applied to patients in clinical field.~     Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for~     survival prolongation compared to chemotherapy only.~   "
70328|NCT02136823|"~     This study is being done to measure the differences between the electrical activity of~     muscles and /single muscle fibers in individuals with long-term spinal cord injury and~     neurologically intact individuals without spinal cord injury. This study is also being done~     to find out if muscle and /single muscle fiber electrical activity, voluntary strength,~     reflex measurements, and/or spasms are changed after a single, oral dose of three commonly~     prescribed drugs, Rilutek®, isradipine, and Namenda®. These medications are approved by the~     FDA for treatment of disorders other than the control of spasms and strength. In this study,~     they are being used in an experimental manner. Finally, this study is also being done to~     find out whether or not a brief stretching exercise influences reflex measurements.~      The main hypothesis of this study is that aberrant current activity in spinal motoneurons~     contributes to spastic hyper-reflexia following chronic spinal cord injury.~   "
70329|NCT02136810|"~     This study aims to assess the performance of presurgical clinic blood pressure measurements~     in predicting home blood pressure readings among surgical patients. It also aims to measure~     the association between home blood pressures and patient perspectives on blood pressure~     control.~   "
70330|NCT02136797|"~     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.~     Tcells are a type of white blood cell that helps protect the body from infection. A~     transfusion is the process by which blood from one person is transferred to the blood of~     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.~     The T-cells are then grown and taught to attack the CMV virus in a lab.~   "
70331|NCT02136784|"~     The aim of this study is to examine the effects of opioid analgesics on acute pain in~     participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven~     medication conditions will be tested in a cold pressor test (CPT) paradigm.~   "
70332|NCT02136771|"~     In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D~     deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3~     supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory~     blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether~     vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity,~     N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett~     formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model~     Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.~   "
70333|NCT02136758|"~     This study was a prospective, randomized trial designed to investigate the efficacy of~     moderate lifestyle modification for improving the clinical status of patients with coronary~     artery disease or patients with risk factors that promote coronary artery disease.~   "
70334|NCT02136745|"~     In this pilot study, the investigators examined whether a relaxation response mind-body~     intervention could be effectively delivered to mixed groups of IBS and IBD patients and~     determined the effects of the intervention on quality of life, inflammatory markers, and~     gene expression using transcriptional profiling.~   "
70379|NCT02136160|"~     Population based intervention at elementary school setting aimed at contributing, to a major~     extent, to health education and health promotion for children aged approximately 5-10 years~     in Germany. Health education units with theoretical and practical exercises for use by~     teachers, children, and parents addresses physical activity, sedentary behavior, relaxation,~     nutrition, personal hygiene and body awareness.~      Main questions of the pilot are:~      Does health promotion take on an important role in primary schools? How do teachers evaluate~     training materials, homepage, content and framework conditions? How do teachers assess the~     efficiency of teaching units?~   "
70335|NCT02136732|"~     With a growing aging population, the number of persons with chronic conditions continues to~     escalate and challenges related to chronic care quality, effectiveness and cost remain~     unresolved.Federally Qualified Health Centers (FQHC) have experienced increasing numbers of~     patient visits for chronic conditions, and FQHC patients are more likely to have serious~     chronic conditions when compared to patients being cared for by non-FQHC providers.~     Effectively managing multiple chronic conditions is particularly challenging for both~     patients and health professionals, and costs of care rise as the number of co-morbid~     conditions increases.FQHCs primarily serve patients with public insurance or those who are~     uninsured. Consequently, simultaneously controlling costs and improving chronic care is a~     critical issue for the FQHC system. Two approaches that have been used to improve health~     status and reduce health care utilization are preventive home visiting and patient~     activation counseling. Preventive home visiting allows for multidimensional assessment and~     individualized, patient-centered care, and there is wide agreement that engaging patients to~     be an active part of the care process is an essential element of the quality of care. This~     concept is known as health activation.~      The Chronic Care Intervention (CCI) combines home visiting with health activation coaching~     and has resulted in improved health status and reduced expenditures (Preliminary Studies).~     However, the model has only been tested with persons with chronic conditions who were~     receiving Medicaid in-home care services who did not have a single or consistent health~     home. By implementing the CCI for aging adults with multimorbidity (2 or more chronic~     conditions) and high baseline acute care utilization, the investigators will test and expand~     the efficacy, external validity and cost effectiveness of the proposed intervention model.~     The investigators seek to improve patients' and FQHCs' abilities to effectively manage~     chronic conditions and reduce acute care use. This contribution is significant because it~     potentially extends our knowledge about effective community partnerships and best practices~     that can enhance the effectiveness of health homes in providing patient-centered team-based~     care for patients with multimorbidity and high baseline health care utilization.~     Specifically, this study will advance knowledge about self-management support and patient~     activation. It will also create opportunities for further study by contributing knowledge~     about the effects of the CCI on key outcomes such as patient-level health status and acute~     care utilization. In addition, the clinical partnerships proposed in this translational~     study give it a high level of external validity that will contribute to advancing knowledge~     about effective care coordination and integration of community resource networks--a goal~     that is even more critical as implementation of the Accountable Care Act begins.~   "
70336|NCT02136719|"~     the investigators aim to compare bimanual uterine compression immediately after delivery of~     the placenta for 5 minutes versus no intervention for the prevention of postpartum~     hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary~     outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes~     include use of additional uterotonics and need for blood transfusion.~   "
70337|NCT02136706|"~     Encouraged by the recent data published ,the investigators think that a waiting time of 10~     minutes is feasible while preserving diagnostic accuracy and would like to assess the~     feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By~     combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial~     perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for~     W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute~     waiting).~      The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the~     patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides~     diagnostic accuracy comparable to W30 MPI.~   "
70338|NCT02136693|"~     This study aims to assess whether fiber intake, formerly recommended only before or instead~     of surgery, may play a role in improving postoperative progress and functional outcome after~     STARR for obstructed defecation, in terms of residual constipation, incontinence and~     defecation urgency.~   "
70339|NCT02136680|"~     This is an investigator-initiated study to measure the impact of an educational intervention~     of the basic palliative approach for a multidisciplinary staff team of an outpatient HIV~     clinic early in disease trajectory. The study aims to 1) refine a curriculum for~     non-palliative clinicians caring for persons living with HIV disease early in disease~     trajectory; 2) assess the impact of this palliative educational intervention on outcomes for~     2 target populations: a) staff (burn-out and caregiving stress) and b) patients (retention~     in care, mental health, and quality of life). It is hypothesized that training outpatient~     HIV staff in palliative competencies will improve care provided that might, in turn, improve~     clinical outcomes for one group of HIV patients receiving care from the clinic. Quantitative~     data will be augmented by qualitative interviews of selected staff and patients in the final~     year of the study to appreciate response to the intervention.~   "
70340|NCT02136667|"~     In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year~     follow-up study comparing 32 exposed (women with a history of pregnancy complicated by~     preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).~      Participants will be recruited from a well-characterised cohort, previously assembled during~     their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in~     2001-2004.~      Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus~     rendering the possibility of longitudinal assessment.~   "
70341|NCT02136654|"~     South Asians (SA) living in Canada and globally have high rates of type 2 diabetes~     (diabetes). Despite the burden of diabetes in this population, diabetes management remains~     poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in~     exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid~     targets for diabetes than the general population (6). 55-60% of SA patients were~     non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in~     the general population (7). This large gap in diabetes care is not surprising given language~     and communication barriers between primary care providers and SA patients (8-10), lack of~     knowledge about diabetes (8-11), preference for alternative therapies (12-14) and~     fundamentally different cultural beliefs on diabetes and diabetes management (15-18).~     Although there is some preliminary evidence that culturally tailored, chronic disease models~     may improve outcomes (21-24), the current evidence base is insufficient to justify the~     system modifications required to provide culturally tailored care across primary care~     settings in Canada. We propose to conduct a randomized controlled trial to assess the impact~     of a novel culturally tailored lifestyle and medication adherence intervention in SA~     patients with poorly controlled diabetes. The study is called the Novel Model for South~     Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.~   "
70342|NCT02136641|"~     Objective: To determine the efficacy of sedation schemes to sedation in patients about to~     undergo spinal anesthesia.~      Methods: Pilot study, clinical type, randomized, prospective, single-blind, in which the~     investigators compared three schemes for sedation in patients undergoing spinal anesthesia.~      Keywords: Anesthesia, Spinal Anesthesia, Conscious Sedation, Operating Rooms.~   "
70414|NCT02135705|"~     This global product exposure registry is a multicentre, long-term, prospective,~     observational cohort study (exposure registry), designed to evaluate the long term safety~     and effectiveness of lomitapide.~   "
70716|NCT02131727|"~     The purpose of this study is to determine if a simple intervention to improve hand hygiene,~     consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can~     reduce respiratory and GI illness among employees.~   "
70343|NCT02136628|"~     The posincisional hernia is considered a delicate complication , with an incidence of 10-12%~     in patients undergoing laparotomy may reach 45% in case of emergency and high-risk patients~     . It is estimated that in the United States are made about a million of reoperations for~     correction of this complication , with millions and despite the myriad studies that have~     been done in recent years there has been a decrease in the incidence losses and mortality of~     this complication.~      Given the seriousness of this problem the last global consensus guidelines sent to the~     surgical community in three main areas: Identify the importance of the problem, improve the~     theoretical knowledge and technical capacity in the closure of the abdominal wall and~     Implement prophylaxis in selected patients.~      The technique of reinforced tension line (RTL) was proposed by hollinsky and collaborators~     and is a strengthening of the abdominal incision with placement of a suture that runs~     lateral to the edge of the incision and closure of the abdominal wall is performed the usual~     manner with the only surgete continuous suture for closure is placed lateral to the suture~     reinforcement.~      In the present study may contribute to these guidelines and to groups of patients at high~     risk were identified and applying the RTL technique and demonstrate that its use is safe and~     useful in reducing the presence of this complication could be implemented as prophylaxis~     handling the same .~      The RTL method was applied experimentally on bodies to close the abdominal wall also be used~     in a cohort of patients for hernia repair wall , showing that by using it the abdominal wall~     is more resistant to shear forces by theoretical foundation that exists to show that could~     prevent the development of incisional hernias. There are no studies in the literature~     comparing this technique against conventional methods of closure of the abdominal wall as to~     the prevention of the same.~   "
70344|NCT02136615|"~     In a recent series of studies performed by our group, we have shown that exposure to~     hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects and~     that this improvement can be measured in all men, not just those with diabetes. The aim of~     this study is to investigate the time course of this effect and explore the mechanisms~     involved when exposure to HBOT induces an increase in peripheral insulin sensitivity.~      Aims:~        1. To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after~          an HBO session.~        2. To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.~   "
70345|NCT02136602|"~     Good glycemic control is superior to poor glycemic control in reducing risk of~     interventricular septal thickness among fetuses of diabetic mothers.~   "
70346|NCT02136589|"~     PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.~      IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not~     clarified.~      Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP~     reduction may be due to secondary induced PGs.~      Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.~   "
70347|NCT02136576|"~     The aim of this pilot research project is to compare the clinical effect on dentinal~     hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate~     (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium~     Phosphate (TCP), and a dentifrice containing Potassium Nitrate.~      The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will~     exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice~     containing Potassium Nitrate).~      The results of this pilot study will validate or negate the need for a larger clinical study~     that may provide generalizable results for using caries-prevention products with the~     additional benefit of minimizing dentinal hypersensitivity.~   "
70348|NCT02136563|"~     This is an observational clinical research on patients with chronic kidney disease who are~     not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the~     major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in~     association with deterioration of renal function as well as occurrence of cardiovascular~     disease events.~   "
70349|NCT02136550|"~     Smoking cessation improves health conditions with reduction of the risk factors for~     cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking~     cessation has positive effects on the miRNAs regulation, however, genomics has been little~     explored. Smoking and aging induces changes miRNAs. Among the changes in airway epithelial~     cells, miR-125 called attention because it is enrolled in the suppression of ERBB7 (tirosin~     kinase receptors), a codified sequence of the growth factor receptor (EGFR) frequently~     expressed in cancer. The reduction of miR-125 expression may reduce cancer suppression~     resulting in cancer development. Other miRNA changes can be observed, such as miR-218 that~     were found in smokers airway epithelial cells as in MiR-15b that were found in lung tissue~     of COPD smokers. These miRNAs participated in the signalling pathway of TGF-β enrolled in~     leukocyte migration and cell proliferation. The investigators hypothesize that smoking~     cessation has a role in the regulation or reduction in the genetic changes smoking-induced.~     The investigators will assess the subject genomic profile at the baseline, 6 months and 12~     months after smoking cessation.~   "
70350|NCT02136537|"~     The investigators wish to investigate the effects of neuromuscular stimulation on~     intermittent claudication.~   "
70351|NCT02136524|"~     This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence~     crossover study to determine the relative bioavailability of cobimetinib administered as a~     single dose of the tablet formulation relative to a single dose of the capsule formulation~     to healthy male and female participants. A minimum of 24 participants (12 participants per~     sequence) will complete the study. Participants will be randomly assigned to 2 possible~     sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One~     cobimetinib tablet administered as a single oral dose after at least an 8-hour fast;~     Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an~     8-hour fast. The study is expected to last approximately 7 weeks.~   "
70352|NCT02136511|"~     This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated~     chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible~     for other Gilead-sponsored studies.~   "
70353|NCT02136498|"~     The purpose of this pilot study is to evaluate the acceptability and feasibility of the~     proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).~   "
70426|NCT02135549|"~     To assess the safety and effectiveness of two doses of SugarDown in two different doses vs.~     placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with~     metformin alone. There will be five visits, a screening visit, baseline visit, and 3~     treatment visits. The study duration will be five weeks. Subjects will all receive placebo~     tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will~     be measured in frequent intervals over four hours immediately following the meal. Subjects~     will be randomized to one of the six treatment sequences. Patients will take in an unknown~     order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown~     immediately before breakfast, lunch and dinner meals. Patients will continue their usual~     metformin regimen during the trial period.~   "
70354|NCT02136485|"~     This application concerns a proposed randomised controlled trial evaluating the use of~     Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in~     secondary care.~      MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental~     health problems are common in MS, can impair quality of life, and lead to higher rates of~     suicide.~      Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress~     and diminish disease activity in MS, but effects are short-lived and there is thus a need to~     explore whether other psychological approaches might be more beneficial in this regard.~      MBSR is another psychological stress reduction technique that is thought to operate~     differently to CBT, via cultivating a state of meta-cognitive awareness and has shown to~     be helpful when used in other long term conditions, such as chronic pain and anxiety, whilst~     Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating~     recurrent depression. All of these conditions are common in MS. However, mindfulness based~     interventions have not been well studied in MS.~      The investigators propose to carry out a feasibility study to assess how acceptable and~     accessible MBSR is as a stress reduction technique in people with MS. The investigators~     would seek up to 50 participants who would then be randomly assigned to receive MBSR or~     their usual care. The investigators would seek measurements of health and wellbeing before,~     immediately following, and 3 months following the MBSR intervention. This would include~     basic demographic information (age, gender, ethnicity), measures of mental health, and~     physical health, as well as qualitative semi-structured interviews with selected~     participants. After this we would offer MBSR to the control group.~   "
70355|NCT02136472|"~     Introduction:~      Overall, 10 - 15% of couples seek specialist help once in their lives when a spontaneous~     pregnancy does not occur. These couples are defined subfertile when there is at least one~     year of unprotected intercourse without conceiving. Subfertility can have different causes~     which can be diagnosed with a basic fertility work-up. Unfortunately, the subfertility in~     25% of the couples still remains unexplained.~      Hypothesis:~      The investigators hypothesize that cardio-metabolic and hemodynamic abnormalities reducing~     cardiovascular reserves relate to circulatory redistribution at the expense of uterine~     perfusion and with it women's fertility. This could especially be important in the subgroups~     with an unexplained subfertility and a decreased ovarian reserve. Interventions to improve~     these abnormalities could lead to better results in fertility treatment, better obstetric~     outcome and reduced lifelong health risks.~      Objective:~      The investigators want to examine specific cardio-metabolic and cardiovascular parameters in~     women of subfertile couples. The investigators want to evaluate the prevalence of metabolic~     syndrome in all women who are assessed for subfertility compared to healthy parous women.~     Furthermore in the women with an unexplained subfertility or with (signs of) a decreased~     ovarian reserve the cardiovascular profile will be studied consisting of the uterine artery~     pulsatility index (PI) as measure of uterine perfusion, the plasma volume as measure of~     venous reserve capacity, the intima media thickness of the carotid arteries as proxy of~     chronic strain and the endothelial function, measured by flow mediated dilatation (FMD) of~     the brachial artery.~      Study design:~      Cross-sectional~      Study population:~      The study group consists of subfertile women between 18 and 41 years who visit the fertility~     clinic in the Maastricht University Medical Centre with a primary or secondary subfertility.~     Women with an unexplained subfertility or with (signs of) a decreased ovarian reserve are~     evaluated for their cardiovascular profile. The control group consists of women with a~     history of an uneventful spontaneous pregnancy.~      Main study parameters:~        1. Prevalence of metabolic syndrome in subfertile women~        2. The cardiovascular profile, in women with an unexplained subfertility or with (signs~          of) a decreased ovarian reserve, consisting of:~             -  The uterine artery pulsatility index~             -  The plasma volume~             -  The intima media thickness (IMT)~             -  The endothelial function of the vascular system (FMD)~   "
70356|NCT02136459|"~     The purpose of this study is to test the investigators hypothesis that intubation with a~     smaller ETT would lead to reduced postoperative vocal impairment and laryngoscopic evidence~     of laryngeal trauma than intubation with a standard size ETT.~   "
70357|NCT02136446|"~     Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to~     one of 2 groups.~      Group 1 will have the nerve block performed using a standard non-echogenic needle and~     catheter under ultrasound guidance. Group 2 will have the block performed using the control~     needle and an echogenic catheter, all under ultrasound (US) guidance.~      The clinician will be blinded to the catheter type and will assess the quality of catheter~     visualisation of the US image during the procedure, along with adequacy of spread of local~     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be~     block success rate and block quality. An assessment of the patient's pain levels after the~     procedure will also be conducted.~   "
70358|NCT02136433|"~     The purpose of the study is to test the effectiveness of training using novel tablet~     applications for hand function, compared to traditional hand exercises. In addition, we aim~     to examine brain plasticity following treatment with the new tablet applications. We~     hypothesize that training with a tablet would prove to be more effective than traditional~     exercises. We expect to observe neuroplastic changes in the brain in patients who practiced~     finger movements using the tablet.~   "
70359|NCT02136420|"~     Adaptation to altered gravity has been of concern from the earliest reports of space motion~     sickness, through the Apollo exploration era, and into current planning of exploration~     missions. The proposed research program takes a new approach which could lead to an~     effective, practical and acceptable protocol for preadapting astronauts to space flight. By~     using the gravito-inertial alterations possible with centrifugation in different body~     orientations the investigators will quantify an individual's sensory adaptation capability~     and use it to predict and to minimize the consequences of movement in any other gravity~     environment - eventually including weightlessness. The investigators will also study whether~     a drug (promethazine) affects motion perception and motion sickness.~   "
70360|NCT02136407|"~     The purpose of this study was to study seasonal inter-individual and intra-individual~     variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy~     Swedish adults.~   "
70370|NCT02136277|"~     The purpose of this study is to investigate whether increases in the blood flow from the~     heart (the cardiac output), induced by the administration of intravenous fluids, lead to an~     increase in the blood flow to the vital organs, in patients undergoing bowel surgery.~      This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the~     research fellow (medical doctor) undertaking this study, who will check their suitability to~     participate in the study and who will obtain informed consent.~      The second phase is the study itself which will take place whilst volunteers are having~     their bowel operation. They will attend theatre in the normal way, but once they have been~     anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be~     placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in~     bowel surgery to help assess how much intravenous fluid to administer to a patient by~     measuring the cardiac output (the amount of blood pumped out of the heart each minute).~     Using the cannula (drip) already inserted in the arm to allow administration of the~     anaesthetic, a special fluid, called an ultrasound contrast agent, will be injected into the~     drip, to allow a contrast enhanced ultrasound scan of the abdominal organs to be performed,~     to measure the blood flow to these organs. A small sample of blood will be taken from the~     earlobe to allow us to measure a chemical in the blood called lactate.~      After this, intravenous fluid will be administered in order to increase the amount of blood~     pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate~     amount of fluid has been given, a second ultrasound scan will be performed to measure~     whether blood flow to the abdominal organs has also increased. A further blood sample will~     be taken from your earlobe to measure any change in lactate level.~      At the completion of the operation, a third ultrasound scan will be performed and another~     sample of blood taken from the earlobe, to help assess blood flow to the organs.~   "
70427|NCT02135536|"~     The purpose of this study is to determine the safety, tolerability, and activity of extended~     treatment with NGM282 in patients with Primary Biliary Cirrhosis.~   "
70361|NCT02136394|"~     Scarring of the lungs is common in patients with scleroderma and is one of the main causes~     of death. Patients with scleroderma very frequently have problems with their gullet~     (esophagus), the food pipe that leads into the stomach.~      Normally, a small circular muscle at the base of the esophagus opens to allow food to pass~     into the stomach and closes to keep the digestive fluids from flowing back up into the~     gullet. In patients with scleroderma, the muscle may become weak and no longer close~     properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents~     into the esophagus.~      Our hypothesis is that small amounts of GER can move back up into the esophagus and get~     inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look~     for certain substances normally only found in the stomach in the exhaled breath condensate~     which is collected by breathing comfortably into a cooled cylinder, allowing the breath to~     condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar~     lavage, a more widely studied test in which a small amount of fluid is introduced into a~     small part of the lungs through a fine tube, and then removed for examination, to evaluate~     whether the two tests provide similar measurements. We will also evaluate the correlation~     between these molecules and other tests, including lung function, and markers of lung~     scarring activity, and tests to look at how the esophagus is working so that we can get a~     clearer picture of how this affects patients' daily lives. Finally, we will be following up~     patients over time with lung function to see whether evidence of GER into the lungs is~     linked with a greater likelihood of worsening of lung scarring in the future.~   "
70362|NCT02136381|"~     The LiveWell research programme aims to develop evidence-based, acceptable and scalable~     interventions to improve health and wellbeing in the retirement transition.~      Life stage transitions involve changes in lifestyle and thus present key opportunities for~     behaviour change interventions. Our assessment of the literature shows that interventions~     with people of retirement age can effectively promote components of the Mediterranean diet~     (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC~     Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q.~     Jun;91(2):222-87: 2013).~      This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking~     place in the North-East of England.~      We have developed an internet-based lifestyle programme (Living, Eating, Activity and~     Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1)~     healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the~     use of a step-counter, and 3) improving social connectedness.~      Participants recruited for this study will be allocated in random order with a ratio of 2:1~     to the intervention group (LEAP) or to a control group.~      This study will evaluate the feasibility and acceptability of the LEAP intervention among~     people of retirement age and will pilot trial procedures.~      In this programme of research we have also defined a suite of outcome measures and~     identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al,~     Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability,~     Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of~     these measures has yet to be determined and therefore will be formally assessed in this~     pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical~     activity and social roles).~      The hypotheses to be tested in the LiveWell programme are as follows:~        -  A newly developed internet-based lifestyle programme (Living, Eating, Activity and~          Planning through retirement (LEAP)) is an acceptable tool for behaviour change among~          people of peri-retirement age.~        -  A suite of outcome measures and identified tools appropriate for capturing the Healthy~          Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.~   "
70363|NCT02136368|"~     The purpose of this study is to investigate whether an exercise class with a cognitive (or~     brain) training component was more effective than a usual combined aerobic and resistance~     exercise class for older adults with cognitive complaints (such as concerns about changes in~     memory or thinking skills). It is hypothesized that the group randomized to the exercise~     class that includes additional brain training will have greater improvements in brain~     health.~   "
70364|NCT02136355|"~     Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers~     high-dose, precise radiation to small tumors in 1-3 weeks of treatment.~      The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done~     first, with surgery done approximately 10 weeks later. There will be some extra imaging done~     before and after the SABR.~      The purpose of this study is to determine how effective SABR is in killing the cancer cells,~     and if SABR can help make surgery more effective.~   "
70365|NCT02136342|"~     The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.~   "
70366|NCT02136329|"~     The objectives of the study are the following:~        -  To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at~          risk of acute kidney injury~        -  To determine the safety and tolerability of Sildenafil in cardiac surgery patients at~          risk of acute kidney injury~   "
70367|NCT02136316|"~     The purpose of this study is to evaluate the safety and tolerability as well as the~     pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and~     female subjects.~   "
70368|NCT02136303|"~     The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In~     Western industrial countries, it is the main cause of visual impairments. In Germany,~     approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are~     mainly important in AMD development. Until now, AMD-patients are advised to use supplements~     based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated~     form. Results showing the effects of food items (kale, spinach) rich in lutein on~     improvement of vision are scarce. And how much is needed within the diet? Within the planned~     project, human intervention studies will investigate whether an oil-based kale extract or~     fresh kale can be used to improve vision of AMD-patients and persons aged 50+ (without AMD).~     The first study will use volunteers without AMD (>18 y) to investigate if there is a~     dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment~     optical density (MPOD). This study will also compare the bioavailability of the carotenoids~     from the extract and from a supplement. A second study (also using volunteers without AMD,~     >18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from~     kale purée. The third study will investigate the effect of the oil-based kale extract on~     improvements of MPOD and vision of AMD-patients and of a control group (volunteers 50+~     without AMD).~      Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing~     changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated~     to check the efficacy of an increased uptake of lutein. Thus, the project will test the~     usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids.~     Besides, the determination of carotenoid contents in skin will be checked on its use as~     biomarker of carotenoids in plasma and macula.~      Thus, the planned research project will evaluate two non-invasive markers of exposition on~     their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In~     addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be~     determined to reduce the possible risk of currently recommended doses of these compounds.~     The project will also present alternatives (kale extract, kale purée) for AMD prevention and~     to improve vision to be used instead of currently used high-dose supplements.~   "
70369|NCT02136290|"~     The primary goal of this clinical trial is to examine whether provision of~     portion-controlled prepackaged foods in the context of a reduced-energy diet prescription~     and counseling is associated with a greater degree of weight loss at three months in~     overweight or obese men and women, compared to usual care or control conditions in which the~     prescribed reduced-energy diet is to be consumed via self-selected foods. The effect on body~     weight and recognized indicators of disease risk, diet quality and cardiopulmonary fitness,~     as well as meal satiety and satisfaction, will also be examined. Participants are 184~     overweight or obese men and women in San Diego area who will be randomly assigned to usual~     care or control conditions.~   "
70726|NCT02131597|"~     The goal of this clinical research study is to learn if SGI-110 can help to control MDS. The~     safety of this drug will also be studied.~   "
70371|NCT02136264|"~     An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats,~     and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary~     food intolerances, followed by remission over a couple of months~     (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts~     relapse and maintains remission of psoriasis, with side benefit on blood pressure and other~     metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis:~     this dietary approach would improve the control of essential hypertension. A randomized~     controlled clinical trial is proposed to compare this dietary approach with conventional~     DASH-type dietary counselling. 40 study participants will be randomly assigned to either~     conventional or interventional dietary counselling. They will be comprehensively monitored~     (including gene expression studies) for two years. Outcome criteria will include blood~     pressure, complications of hypertension, side-benefit on comorbidity, and requirement for~     antihypertensive drugs.~   "
70372|NCT02136251|"~     We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder~     arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we~     suggest that the absence of radiolucent lines will correlate with excellent shoulder~     function.~   "
70373|NCT02136238|"~     This study will compare the functional performance of voluntary opening (VO) and voluntary~     closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension~     and produce progressively higher pinch from shoulder force will result in advantages for the~     VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The~     specific aims of this clinical trial are to:~        1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced~          compensatory motion during activity.~        2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function~          in activities of daily living.~   "
70374|NCT02136225|"~     The purpose of this project is to examine the implementation and effectiveness of an~     intervention, delivered in a health care setting, to decrease home firearm access by youth.~     The investigators hypothesize that:~        1. parents who receive means restriction education provided by their primary care provider~          will be more likely to report, at the one month and one year follow-up, that they are~          storing their guns locked compared to parents who do not receive means restriction~          counseling.~        2. parents who receive a free gun locking device(s) will be more likely to report, at the~          one month and one year follow-up, that they are storing their guns locked compared to~          parents who receive means restriction counseling alone;~        3. parents whose adolescents are assessed at high risk for violence (> 5 on the Violence~          Injury Protection and Risk Screen (VIPRS)) or depression (>9 on the Patient Health~          Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at~          the one month follow-up compared to parents whose children are assessed as low risk,~          regardless of whether they receive the counseling alone or counseling plus free locking~          devices and 4) youth whose parents receive a free gun locking device(s) will be more~          likely to report less access to guns, at one year follow-up, compared to parents who~          receive means restriction counseling alone.~   "
70375|NCT02136212|"~     The purpose of this study is to test the effects of a computerized approach/avoidance~     training (AAT) procedure in a sample of individuals diagnosed with social anxiety disorder~     (SAD). The training procedure is designed to modify automatic approach responses for~     positive social stimuli. Previous research has shown that a single administration of~     approach-positive AAT influences social behavior in the laboratory. The goal of this study~     is to examine the effects of a four-session AAT procedure on measures of positive~     social-emotional functioning. The investigators hypothesize that individuals assigned to the~     approach-positive AAT condition will demonstrate larger increases in positive affect and~     improvements in social relationship functioning from pre- to post-assessment compared to~     those assigned to the control condition.~   "
70376|NCT02136199|"~     The active strategy for dissemination and implementation of Share Evidence Based Medicine~     (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and~     a greater uptake of use amongst encounters will be seen.~      The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with~     expertise in large-scale practice improvement at the state and national level. Largely~     funded by health organizations in Minnesota, ICSI has a sustainable model to translate~     evidence into practice, through clinical practice guidelines, shared decision making, and~     practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may~     lead to a sustainable and innovative approach to the dissemination of evidence-based health~     information at the point of care.~      The objective of the current study is therefore to leverage the expertise of these two~     organizations to compare the impact of an active to a passive dissemination and~     implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate~     evidence-based information through the use of decision aids during encounters. The overall~     purpose of the qualitative evaluation is to understand why decision aids were used more or~     less in certain practices and what factors contributed to or hindered this uptake.~   "
70377|NCT02136186|"~     This study will evaluate the efficacy of home telemonitoring as an intervention to decrease~     hospital readmissions in patients at high risk for readmission. The overall readmission rate~     for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to~     identify and score all MCF patients for their risk of readmission. This score is based on~     multiple variables including but not limited to: co-morbid conditions, patient's health~     literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and~     whether they have had prior hospital admissions within the previous year. The literature~     shows that home telemonitoring of patients has had mixed results for effectiveness at~     preventing hospitalizations and emergency department visits. Many of these reports have~     restricted studies to patients with specific diseases or general characteristics; some have~     shown improved results while others have not. No study has examined patients who are high~     risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces~     the risk for 30-day readmission.~   "
70378|NCT02136173|"~     The effect of the balloon on weight loss is investigated by multiple studies. However, the~     effect of the sequential balloons is not studied yet.~   "
76162|NCT02060409|"~     In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate~     the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2)~     on the outcomes of 1st line decitabine treatment in MDS.~   "
70380|NCT02136147|"~     ADHD medication of children and adolescents is becoming increasingly common. Clinical~     experience and scientific studies have proven that approximately 30% of children/adolescents~     with ADHD do not benefit from this treatment. However, there is insufficient knowledge about~     who these children are. All children and adolescents, who start treatment with ADHD~     medication at the Child and Adolescent Psychiatry units in Stockholm, will be asked to~     participate in the study. The investigators intend to monitor the patients´clinical symptoms~     and possible side-effects after treatment start. The investigators will collect background~     information, saliva and blood samples to be able to study if there are any genetic~     (hereditary) or other markers that can predict positive or negative outcomes of the ADHD~     medication. With this information, the investigators aim at, to a greater extent, be able to~     individualize treatment choices for children and adolescents with ADHD without unnecessary,~     costly and possibly unfavorable treatment attempts.~   "
70381|NCT02136134|"~     The purpose of this study is to assess the effects of administration of daratumumab when~     combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and~     dexamethasone alone, for participants with relapsed or refractory multiple myeloma.~   "
70382|NCT02136121|"~     To determine the feasibility of representative urologic procedures as measured by the rate~     of conversions~   "
70383|NCT02136108|"~     The OPEN study has two aims: The first is to identify what helps to keep patients involved~     with a Medicaid chronic pain management program and to identify features of an ideal~     text-message-based program for people enrolled in the program. The second aim is to develop~     the text-message-based program (OPENtext), then find out how useful this intervention is~     compared to a patient navigator intervention (OPENnav) for increasing patient engagement,~     improving patient's motivation to manage their chronic pain, and improving patient~     confidence in self-managing their chronic pain condition.~   "
70384|NCT02136095|"~     Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is~     a recently developed method for non-invasive visualisation of the relevant anatomy during~     laparoscopic cholecystectomy. The objective of this study was to assess the time required by~     routine-use of IFC and to evaluate success-rate of the procedures.~      Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the~     same surgeon were consecutively enrolled. A standardized protocol with IFC including~     concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative~     time-registration and exposure of predefined anatomical structures were recorded.~   "
70385|NCT02136082|"~     Building upon the successful qualitative Phase I of the study, Phase II commences in month~     10. The Project manager and research staff will recruit 600 women living with AIDS (WLA) and~     their oldest child between the ages of 3 and 8. The WLA will be recruited from Primary~     Health Centers (PHCs) randomly selected from 72 closest PHCs in terms of HIV prevalence in~     the rural Andhra Pradesh (AP) area of Nellore. WLA will be recruited by means of approved~     flyers posted in selected PHCs. Interested WLA will approach the research staff, stationed~     at the PHC to be screened for eligibility via a consent script. Once eligibility is~     determined for the WLA, based upon the following criteria: age, HIV and ART status~     (validated by ART and HIV card); having a child (3-8 years) and whether or not the WLA was a~     participant of the previous intervention group from the Asha pilot study, a parental consent~     will be obtained from the WLA for permission to include her oldest child in the study. The~     oldest child between 3-8 years of age will be brought in to the research office or PHC~     (after mother speaks with the child at home). All children will have blood work drawn and~     physical health assessment on their first visit (total of 15 minutes). All eligible WLA will~     undergo a second consent for enrollment. General Procedure: Following informed consent, the~     WLA will be randomly assigned into one of four programs 1) Asha Support Only; 2) Asha~     Support + Training; 3) Asha Support + Food; or 4) Asha Support + Training + Food. After~     blood draw and physical assessment of the WLA, an appointment will be made for the assigned~     interviewer (blinded to program) to visit the WLA at their home preferably (or other~     location of choice) to conduct several 24 hour dietary assessments. Urine will be collected~     in labeled bottles on the morning after the 3rd day of the diet recall by the interviewer~     and sent directly to the lab in a cooler. Also, on the same day, the baseline assessment~     will be entered into the PC tablets; 50 minutes estimated with breaks). After a longer~     break, the WLA will then be asked to respond to additional questions about the~     sociodemographic and psychomotor development of their child (about 30 minutes). Interviewers~     will visit the WLA monthly until the end of the intervention (month 6) to provide individual~     weekly Asha Support and conduct group sessions and collect ongoing data, 24-hour recall, and~     ART pill count for WLA, and follow up questionnaires at 6-, 12- and 18-months.~   "
70386|NCT02136069|"~     This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group~     study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with~     infliximab in treating patients with moderate to severe ulcerative colitis (UC) who are~     naive to tumor necrosis factor (TNF) inhibitors. Patients will be randomized in a 1:1 ratio~     to receive either etrolizumab (105 mg by subcutaneous injection [SC] every 4 weeks [Q4W]) +~     placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8 weeks) or infliximab~     (5 mg/kg IV at Weeks 0, 2, and 6, then every 8 weeks) + placebo (SC Q4W). Time on treatment~     is 54 weeks.~   "
70387|NCT02136056|"~     The purpose of the current study is to determine the efficacy of a self-management course~     for workers on sick-leave as an add-on to standard rehabilitation care and follow-up~     (treatment as usual). Outcomes are registry based measures of return to work, and~     questionnaire based measures of well-being and quality of life.~      We thus, hypothesize that the program will improve workers return to work rates and~     self-reported/psychological well-being.~   "
70388|NCT02136043|"~     The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation~     (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to~     minimize any patient reported discomfort during treatment procedure.~   "
70389|NCT02136030|"~     To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B~     deoxycholate with or without flucytosine followed by fluconazole for the treatment of~     cryptococcal meningitis.~   "
70390|NCT02136017|"~     To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun~     Institute of Biological Products Co.,Ltd.~   "
70391|NCT02136004|"~     The objective of this trial is to demonstrate the safety and effectiveness of the Rex~     Medical Closer Vascular Sealing System in sealing femoral arterial access sites.~   "
70392|NCT02135991|"~     Young people can engage in a variety of negative behaviors—such as drug use, underage~     drinking, and premarital sex—that exact a high toll on local communities. These activities~     are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an~     approach that includes a toolkit, technical assistance, and training, organized around a~     10-step process, that helps communities plan, implement, and evaluate the impact of their~     programs that attempt to prevent these negative behaviors. This study will examine the~     degree to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based~     drug prevention program.~   "
70393|NCT02135978|"~     The purpose of this study is to determine if a shoulder exercise program can prevent the~     onset of shoulder pain and improve community participation in persons who have a spinal cord~     injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be~     followed for 3 years to determine rate of shoulder pain development. Patients will learn a~     simple shoulder home exercise program and will be instructed on techniques to protect their~     shoulder during wheelchair propulsion, transfers and activities of daily living. Patients~     will be instructed to perform the home exercise program 3 days per week. Two types of~     treatment (training) delivery approaches that have been documented to reduce chronic~     shoulder pain will be compared. The rate of shoulder pain development for the two groups~     will be compared to the rate of shoulder pain development in the historical control group.~     The investigators hypothesize that the rate of shoulder pain development will be lower in~     the experimental treatment groups compared to the historical control group. Any differences~     between the two treatment delivery approaches for the experimental treatment groups will~     help to provide guidelines for the most effective delivery approach of a shoulder pain~     prevention program.~   "
70394|NCT02135965|"~     The purpose of this study is to define a ratio of Caffeine and albuterol that gives a~     synergistic increase in metabolic rate.~   "
70395|NCT02135952|"~     Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic~     and oral complications, such as periodontitis. The use of adjunctive local and/or systemic~     antimicrobials has been proposed to improve the clinical and glycemic outcomes of the~     scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ)~     and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the~     clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis~     (ChP). However, no previous clinical trials to date have evaluated the effects of this~     antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore,~     the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and~     microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2~     diabetic subjects with generalized ChP.~   "
70396|NCT02135939|"~     In this randomized study the investigators aim to determine the effects of a whole-food~     plant-based vegan diet on markers of inflammation and glucometabolic profile in patients~     with cardiovascular disease. The investigators hypothesize that a whole-food plant-based~     vegan diet will reduce markers of inflammation and improve glucometabolic profile compared~     with the American Heart Association (AHA)- recommended diet at 2 months follow-up in~     patients with coronary artery disease (CAD). The investigators are also evaluating~     endothelial function using the EndoPAT device and stool microbiome.~   "
70397|NCT02135926|"~     the purpose of this study is to to compare the safety and effectiveness of stent-retrievers~     as a device class group with best medical care alone in the treatment of acute ischemic~     stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.~   "
70398|NCT02135913|"~     This is a pilot study to determine the association between Vitamin D deficiency in obese~     children and low high density lipoprotein (HDL) and dysfunctional HDL.~   "
70399|NCT02135900|"~     The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep~     apnea syndrome (OSAS).~   "
70400|NCT02135887|"~     This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate~     efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules~     tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their~     primary tumor.~   "
70401|NCT02135874|"~     The goal of this clinical research study is to learn if the combination of clofarabine,~     idarubicin, cytarabine, vincristine, and dexamethasone, with or without rituximab, can help~     to control mixed phenotype acute leukemia. The safety of this combination will also be~     studied.~   "
70402|NCT02135861|"~     Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the~     treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated~     heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic~     contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for~     assessing changes in vascular permeability and interstitial water volume. The aim of this~     study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging~     and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular~     permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy~     volunteers (HV) (group 1) at rest to determine if there is a difference between the two~     populations. Apart from this, exercise induced changes relative to rest in interstitial~     volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally,~     the capability of DCE-MRI to detect changes in interstitial lung fluid in patients with~     acute decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of~     pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and~     subsequently after receiving standard of care treatment to determine whether differences can~     be detected by this methodology.This study will enrol a sufficient number of subjects to~     have at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF)~     and atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient~     quality to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will~     have screening visit and 3 MRI sessions. For the first scanning session, subjects will~     undergo the baseline procedure. The second imaging session will occur approximately one week~     later to measure within subject variability. A third imaging session (which will be~     conducted in 2 visits) will incorporate a bicycle exercise challenge prior to the MRI scan,~     and this third scan will be performed approximately one to three days after the second~     imaging session. For group 3: Screening will occur during hospitalization for eligibility.~     Session 1of MRI will be conducted while the subject is still hospitalized. Session 2 will be~     conducted within 4 weeks of the first scan, when the signs of pulmonary oedema are~     considered to be resolved. If a subject's pulmonary oedema has not resolved at Session 2,~     then the subject will be not be scanned by MRI at Session 2 and will be brought back for~     Session 3 up to 4 weeks after Session 2 for their second MRI.~   "
70403|NCT02135848|"~     This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety~     of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and~     walking ability in subjects with PAD and symptomatic claudication.~   "
70404|NCT02135835|"~     The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in~     patients with acute heart failure.~   "
70405|NCT02135822|"~     The purpose of this study is to determine the efficacy and safety of nanoparticle~     albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in~     Chinese patients with advanced pancreatic ductal adenocarcinoma.~   "
70406|NCT02135809|"~     The purpose of this study is to document the performance of a new Fully Covered Self~     Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in~     patients with painful chronic pancreatitis.~   "
70462|NCT02135068|"~     This study is designed to look at how snacking during exercise may help prevent low blood~     sugars while subjects are on the closed loop artificial pancreas. This system uses a~     continuous glucose sensor, an insulin pump, and a computer program that automatically~     determines how much insulin to give based on the sensor glucose level.~   "
70407|NCT02135796|"~     The investigators hypothesize that not all patients with severe sepsis or septic shock with~     a Central Venous Oxygen Saturation (ScvO2) less than 70% have cardiac dysfunction that would~     benefit from inotropic therapy (a key strategy in early goal directed therapy in patients~     with sepsis). Echocardiography might show that despite an adequate Central Venous Pressure~     (CVP), intravascular volume status is low and further volume expansion is warranted.~     Alternatively, echocardiography may indicate that left atrial pressure is elevated, and~     further intravascular volume resuscitation should be limited. Such observations may lead to~     a role for echocardiography within the parameters of the early goal-directed therapy~     protocol that may improve treatment of cardiac dysfunction and hypovolemia.~      The study objective is to correlate echocardiographic findings with objective parameters,~     namely central venous pressure (CVP) and central venous oxygen saturation (ScvO2), measured~     during the early resuscitation of critically ill patients with severe sepsis and septic~     shock.~      Aim #1: Correlate echocardiographic findings of right ventricular (RV) systolic function and~     dilation, left ventricular (LV) systolic function and dilation, and left ventricular~     diastolic function with CVP and ScvO2 in the early hours of resuscitation in patients with~     severe sepsis and septic shock.~      Aim #2: Evaluate the change in RV and LV dysfunction over time in patients with severe~     sepsis and septic shock and correlate with mortality.~      Aim #3: Evaluate the efficacy of bedside echocardiography performed by the intensivist in~     the ICU in the evaluation of patients with severe sepsis and septic shock.~   "
70408|NCT02135783|"~     Decompressive craniectomy has been reported for the treatment of patients with intracerebral~     hemorrhage. But no prospective randomised controlled trials have yet been undertaken to~     confirm its effect.The purpose of the study is to determine whether decompressive~     craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the~     chances of a person dying or surviving with a long term disability.~   "
70409|NCT02135770|"~     Sepsis is a clinical syndrome which infection trigger systemic inflammatory response.~     Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early~     mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used~     either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin~     also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor~     necrosis factor alpha.~      Aim of this study is to determine effects of low dose unfractionated heparin treatment on~     inflammation in severe sepsis patient.~   "
70410|NCT02135757|"~     This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact~     and resistance mechanisms of panitumumab in the treatment of patients with~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~      This study will address two anticipated issues surrounding personalized medicine and~     treatment with panitumumab. First, it will enable to assess the economic impact of~     panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based~     mechanisms of resistance, which may lead to new avenues for combination therapy in~     metastatic colorectal cancer (Blood study).~      The primary objective is to collect information on quality of life and health care resource~     utilization by patients diagnosed with metastatic colorectal cancer. The secondary~     objectives are to confirm survival data, to assess the quality of life of patients and to~     assess the health care resource utilization of patients. The blood biomarker study objective~     is to determine blood-based biomarkers of response or resistance to panitumumab.~      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will~     participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will~     be treated with panitumumab and will participate to the HEOR study and to the blood~     biomarker study.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in~     the study and at every 3 months after treatment initiation. For patients participating to~     the blood study (patients with a wild type KRAS), blood samples will be collected before~     patients start their treatment, at every treatment and when they discontinue their~     treatment.~   "
70411|NCT02135744|"~     Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease~     (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to~     determine whether a screening and educational tool, administered prior to discharge, would~     result in a decrease in the rate of hospital readmissions.~   "
70412|NCT02135731|"~     We are studying patients' abilities to correctly identify the prescription medications they~     are taking. We are interested in understanding what tools will help patients correctly~     identify their medications. People participating in this study will be asked to either~     review a paper printout of their medication list or a computer program with their~     medications. The program will show the names and pictures of the medications. In either~     situation, participants will be asked to indicate if they are taking the medications as~     prescribed. We will then compare reported adherence between each medication review process.~     Participation may help the program developers improve the product.~   "
70413|NCT02135718|"~     This is a multicenter, stratified, and randomized, open-label, placebo study in subjects~     with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose~     inhalers (MDI). This study is conducted to evaluate subject's preference of several~     inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry~     powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and~     their asthma must be controlled on their current therapy were enrolled. Subjects meeting the~     eligibility criteria will be stratified according to their current inhaler use (stable for~     the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.)~     Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in~     the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this~     includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were~     randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily~     in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed~     by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will~     be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1~     presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2~     presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of~     the second trial period, subjects answered questions which assessed their preference of~     inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.~   "
70415|NCT02135692|"~     This is a multi-center, open-label, long-term study of subcutaneously (SC) administered~     mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe~     eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who~     have demonstrated clear benefit from therapy and who without continuation of mepolizumab~     therapy are individuals at greatest risk of serious deterioration of their health status. In~     order to target individuals at greatest risk for serious deterioration of their health~     status, only subjects from the MEA115661 study with a history of life-threatening or~     seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the~     eligibility criteria for the study will be offered the opportunity to consent for this study~     of up to 128 weeks in length (including the Follow-Up Visit). This study will give~     opportunity to extend the collection of clinical data for long-term use and further assess~     the sustainability of efficacy in a population likely to experience significant loss of~     asthma control and the need for higher doses of systemic steroids if returned to SOC only.~   "
70416|NCT02135679|"~     Patients with NSCLC who undergo radiation as part of a definitive course of treatment will~     be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We~     will collect demographic and treatment data and explore & describe the pattern of CTC~     detection in all patients~   "
70417|NCT02135666|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A~     and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and~     hepatitis B vaccine, Twinrix.~   "
70418|NCT02135653|"~     This study will ascertain the feasibility and effect of Eischens yoga interventions on~     radiationrelated fatigue, sexual dysfunction and urinary incontinence in stage I /II~     prostate cancer patients undergoing radiotherapy with photons and/or protons without~     prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months~     prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and~     complete 4 quality of life forms 5 times during study.~   "
70419|NCT02135640|"~     This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics~     of denosumab administered subcutaneously to healthy adults in China.~   "
70420|NCT02135627|"~     Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly~     recognized as a result of oncological advances and improved detection methods, and stems~     from local vessel damage and tumor invasion with associated derangements in the hemostatic~     system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB~     due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and~     perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower~     gastrointestinal neoplasms are scarce and associated with varying success in initial~     hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality~     treatment approaches include radiation therapy, interventional angiography, and surgery. All~     exhibit disappointing rebleeding rates, and in the case of emergency surgery, high~     mortality(4, 8-11). Challenges associated with bleeding tumors include hematological~     derangements such as thrombocytopenia, disseminated intravascular coagulation, and~     neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces~     when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada,~     Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel~     endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with~     promising uncontrolled observations having just been published by our group(13) and~     others(14). More robust controlled evaluative data are now needed. We propose to study the~     use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of~     care, and more specifically seeks funding for a pilot study to inform a subsequent~     peer-review application for a larger, more definitive randomized clinical trial (RCT).~   "
70421|NCT02135614|"~     This study is to evaluate the antiviral effect, pharmacokinetics, safety, and tolerability~     of presatovir in respiratory syncytial virus (RSV) positive adults who have been~     hospitalized with acute respiratory infectious symptoms.~      Participants will receive 1 dose of presatovir and followed for 28 days postdose. Nasal~     swabs will be collected at each study visit (excluding Day 28) and assayed for change in~     viral load as the primary endpoint.~   "
70422|NCT02135601|"~     Water exchange method has been shown to reduce medication requirement and pain experienced~     during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange~     provides salvage cleansing and the refractive index of water (n equals about 1.3) is larger~     than that of air, which creates optical distortion that likely contributes to objects~     appearing larger underwater, making smaller lesions easier to visualize and it may help draw~     attention to those smaller lesions during withdraw. These principles facilitate to the~     higher adenoma detection rate.~      There is a large number of literature on the adenoma detection rate during water exchange~     colonoscopy, but most studies have been conducted in only one centre, simple-size, and under~     sedation patients, the influence of adenoma detection rate under unsedation patients was~     unclear.~      The aim of this study is to compare the ADR of colonoscopy by using the water exchange~     method versus the conventional air method in unsedation patients in multiple centers in~     China.~   "
70423|NCT02135588|"~     The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase~     alfa and tPA administered to patients with clinical failure of small-bore chest tube with~     persistent pleural effusions or malignancy-related loculated effusion to improve pleural~     drainage.~   "
70424|NCT02135575|"~     The hypothesis of the present study is that physical training can oppose detrimental changes~     in cardiovascular and metabolic health associated with estrogen loss after menopause.~   "
70425|NCT02135562|"~     This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for~     weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in~     carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of~     only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein~     requirements based on the individual's body weight. The PSMF may help endometrial cancer~     survivors achieve significant weight loss, reduce the risk of chronic disease, and improve~     quality of life.~   "
70727|NCT02131584|"~     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to~     control fatigue and other symptoms in patients with CLL who do not need treatment for the~     cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged~     lymph nodes and/or lower the number of CLL cells in the blood.~   "
70428|NCT02135523|"~     1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally~          recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional~          phase 2 clinical trial~        2. Study period: 2014.04~2018.04~        3. Objective: To determine whether involved-field radiation therapy will prove to be~          improve 2-year progression free survival for residual or locoregionally recurrent~          epithelial ovarian cancer patients after definitive treatment.~        4. Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)~        5. Planned number of patients~             -  YUHS database have 149 FIGO stage III patients treated with debulking surgery and~               adjuvant platinum-based chemotherapy 2.~             -  Of these patients, 90 patients experienced locoregional failures, and then the~               investigators selected 44 patients who could be treated effectively with IFRT~               based on MDACC suggestion.~             -  Median interval to failure was 9 months in these patients~             -  Hypothesis; IFRT reduces 30% hazard of progression compared with patients without~               IFRT~             -  Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power =~               0.80 Null progression-free median survival = 9 mo Alt progression-free median~               survival = 13 mo Calculated sample number = total 64 patients Drop rate = 10% •~               Total sample number = 70 patients~        6. Radiation therapy: Participants will receive involved-field radiotherapy (external beam~          radiotherapy or brachytherapy) over 45Gy with 1.8-2.0 Gy fraction, five times per week~          for residual or locoregionally recurrent epithelial ovarian cancer after definitive~          treatment~             -  Target volume~                  -  directed to gross disease plus a high-risk clinical target volume (CTV) that~                    included the postoperative bed or the prechemotherapy extent of disease with~                    a 1- to 1.5-cm margin, excluding uninvolved clinical structures~                  -  Additional CTVs were designated according to the risks of microscopic disease~                    spread, proximity to critical structures, and other risk factors for~                    complications.~                  -  Nodal CTVs included grossly involved lymph node sites, extending to cover~                    adjacent uninvolved regions.~             -  Modality; 3-dimensional conformal RT including electron, intensity-modulated RT,~               proton beam RT~        7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after~          radiation therapy~        8. Key words: ovarian cancer, involved-field radiation therapy, progression free survival~   "
70429|NCT02135510|"~     In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and~     palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard~     to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced~     by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy~     (MEC).~   "
70430|NCT02135484|"~     The goal of this clinical research study is to learn more about how the study drug~     alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.~   "
70431|NCT02135471|"~     Smoking has a negative effect on the predictability and stability of root coverage~     procedures because of decreased blood supply and fibroblast activity. Long-term evaluation~     of this procedure in smokers is important for clinical decision making, because it provides~     information about the stability of results over time. In smokers, enamel matrix derivative~     (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an~     alternative to improve the deficient healing potential, since EMD has the capability of~     stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the~     deficient fibroblast activity in smokers and therefore reduce the presence of a long~     junctional epithelium. The aim of this randomised controlled clinical study was to~     investigate whether EMD contributes to the root coverage of gingival recessions performed~     with ADMG in smokers during a 12-month follow-up.~      Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be~     selected. The test group will be treated with an association of ADMG and EMD, and the~     control group with ADMG alone. Some clinical parameters as: probing depth, relative clinical~     attachment level, gingival recession height, gingival recession width, keratinized tissue~     width and keratinized tissue thickness will be evaluated before surgery and after twelve~     months.~   "
70432|NCT02135458|"~     Heart failure is the principle cause of hospitalisation for people over 65. the assumption~     is that a system of home based telemonitoring can reduce the rate of unscheduled~     hospitalisation or rehospitalisation for heart failure (compared to a care package alone),~     This randomised controlled pilot study should assess the feasibility in terms of patient~     inclusion and follow-up.~   "
70433|NCT02135445|"~     The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and~     maintaining testosterone suppression.~   "
70434|NCT02135432|"~     The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of~     orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease.~     Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily~     (BID).~   "
70435|NCT02135419|"~     This randomized phase III trial compares topical or ablative treatment with active~     monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and~     high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal~     that has been damaged by infection with human papillomavirus (HPV) and is at risk for~     turning into anal cancer. It is not yet known if treating HSIL is more effective than active~     monitoring in preventing patients from developing anal cancer.~   "
70436|NCT02135406|"~     The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T~     cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19~     cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB~     administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T~     cells on day +2 after autologous stem cell infusion following high-dose melphalan.~   "
70437|NCT02135393|"~     The aim of this study is to test the assumption that, in humans, folic acid, a dietary~     supplement is biotransformed (reduced and methylated) to the natural circulating plasma~     folate 6S-5Methyltetrahydrofolic acid (5-MTHF) in the intestinal mucosa.~   "
70438|NCT02135380|"~     Despite intense research efforts and clinical trials, there is still no effective treatment~     that can prolong the survival of patients with IPF. Conventional therapeutic approach~     includes combination of corticosteroids, anti-oxidants, immunodepressants and immune~     modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so~     far, therapeutic approach that has been proven effective in terms of prolonging patient's~     survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible~     for lung transplantation; there is a significant proportion of these patients that finally~     succumb while waiting in a lung transplantation list. Therefore, there is critical need for~     more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to~     represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be~     easily and safely be applied as a novel therapeutic agent in chronic and fatal lung~     diseases, including chronic obstructive pulmonary disease (COPD) and IPF.~      Therefore, there is an urgent need to provide a safe, effective and affordable treatment~     option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be~     developed to reduce the burden of IPF. Given the present lack of appropriate treatment~     adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new~     opportunities for development of the same.~      MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary~     fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic~     pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules~     involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This~     cell surface configuration may enable mesenchymal stem cells to home from bloodstream to~     mesenchymal tissue.14~      As limited clinical information is available about use of SVF and MSC in the IPF patients~     hence this Open Label, Prospective, Randomized multi center comparative study has been~     undertaken to explore the tolerability & effectiveness of SVF in one treatment arm and MSC~     in second treatment arm in IPF patients.~      Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in~     preclinical studies to be safe and effective~   "
70439|NCT02135367|"~     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)~     to treat knee degenerative articular cartilage pathology could determine pain relief and~     recovery of knee function with overall clinical outcome comparable or even better than~     viscosupplementation, which is a common injective approach applied in this kind of~     pathology. To this purpose the investigators designed a double blind randomized controlled~     trial comparing PRP vs viscosupplementation.~      A power analysis has been performed for the primary endpoint of IKDC subjective score~     improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of~     15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal~     clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean~     improvement, the minimum sample size was 83 for each group. Considering a possible drop out~     of 15%, 96 patients per group are required for total 192 patients, selected according to~     well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then~     assigned to two different treatment groups, according to a randomization list. The first~     group of treatment consists of three weekly intra-articular injections of autologous PRP~     obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2~     centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second~     at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of~     PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for~     analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.~      The second treatment group consists of patients receiving three weekly injections of~     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500~     kDa).~      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain~     autologous PRP which will be used only in half of them, according to the aforementioned~     randomization list. One week after the PRP production, the injective treatment starts, with~     3 weekly injections of PRP or HA. At the moment of the injection the syringe is properly~     covered to prevent the patient from discovering the substance he was receiving. After the~     injection, patients are sent home with instructions to limit the use of the leg for at least~     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,~     the use of non-steroidal medication is forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
70440|NCT02135354|"~     This project (funded by the IWT-TBM program) will organize a randomised placebo-controlled~     multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of~     azithromycin therapy in the acute setting of COPD exacerbations requiring hospital~     admission. Although long-term use of azithromycin is proven effective to prevent~     exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of~     the azithromycin treatment and by restricting the treatment to acute periods with highest~     risk for treatment failure, benefits may counterbalance potential side effects, which may~     result in a new treatment strategy for these acute events.~      The present study is designed by the services of respiratory medicine of the Leuven and~     Ghent University hospitals but will run in total in 17 different large hospitals in Belgium,~     of which 12 are located in Flanders.~   "
70441|NCT02135341|"~     The objectives of this study is to evaluate and compare the efficacy and safety between 100~     U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A~     suburothelial injections and 50 U urethral injection for the treatment of detrusor~     overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents~   "
70442|NCT02135328|"~     The purpose of this study is to use a community based participatory action research (CBPAR)~     approach to 1) create radio stories about Somali, Latino and Hmong families' real success~     stories with type 2 diabetes mellitus (DM) in managing their disease through implementation~     of healthful lifestyle behaviors (nutrition and physical activity), and 2) test the~     effectiveness and acceptability of radio stories on participant intentions to engage in or~     improve healthful lifestyle behaviors. Participants in the Intervention condition listened~     to the radio stories and the participants in the control condition listened to an audio~     brochure with relevant information. We hypothesized that the intervention participants would~     report higher intensions to engage in various healthful lifestyle behaviors than the control~     participants after both participants listened to their respective health information.~   "
70443|NCT02135315|"~     The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24~     hours can improve the prognosis in the short and long term.~      We confront two treatment strategies (standard and intensive treatment) to evaluate their~     superiority in the treatment of acute coronary syndrome.~   "
70444|NCT02135302|"~     This is a multi-center, open-label clinical study to assess the single-dose PK of~     eravacycline in subjects with hepatic impairment and healthy subjects conducted at~     approximately 3 sites in the United States. This study includes an up to 21-day Screening~     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks~     (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be~     enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for~     each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and~     severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects~     will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI).~     All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).~   "
70445|NCT02135289|"~     Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID~     patients treated with anti-TNF can be a serious problem. This study aims to investigate the~     role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of~     the study, patients of other immune-mediated inflammatory diseases (IMID) will also be~     included to investigate the role of serial interferon-gamma release assays (IGRA) for the~     diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory~     diseases (IMID) treated with biologics~   "
70446|NCT02135276|"~     This is a multi-center, open-label clinical study to assess the single-dose PK of~     eravacycline in subjects with renal impairment and healthy subjects conducted at~     approximately 2 sites in the United States. This study includes an up to 21-day Screening~     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks~     (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6~     subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will~     be matched to renally impaired subjects in gender, age, and body mass index (BMI). All~     subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).~   "
70447|NCT02135263|"~     The purpose of this study is to determine whether differences in the gene coding for the~     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1~     dependent drugs, enalapril and methylphenidate.~   "
70448|NCT02135250|"~     This study aims to discuss whether the combined treatment of traditional Chinese medicine~     (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does~     effect, namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM~     - Xinkeshu tablets.~   "
70449|NCT02135237|"~     Contingency management (CM) treatments are highly efficacious in improving outcomes of~     substance abusing patients. However, CM has rarely been applied to individuals with alcohol~     use disorders, primarily because of technological limitations in monitoring drinking. The~     Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to~     continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of~     this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total,~     120 alcohol abusing or dependent patients initiating outpatient treatment at community-based~     clinics will be randomly assigned to one of two conditions: standard care, or standard care~     plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care,~     it is expected that CM will result in fewer drinking days and longer durations of continuous~     non-drinking days.~   "
70450|NCT02135224|"~     The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix~     and possibly result in a shorter duration of vaginal delivery.~   "
70451|NCT02135211|"~     The objective of this proposal is to test the feasibility and acceptability of a lifestyle~     risk reduction intervention for patients with lung cancer receiving surgical treatment. This~     study will provide the preliminary data needed to conduct a larger randomized controlled~     trial that tests an innovative, multidisciplinary intervention that has the potential to~     transform the standard of care for patients receiving surgical treatment for lung cancer.~   "
70728|NCT02131571|"~     Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected~     patients older than 50 years.~   "
70452|NCT02135198|"~     GABA (gamma-aminobutyric acid) is the main inhibitory compound in the human brain. Drugs~     that enhance its effects by binding on GABA receptors (e.g., benzodiazepines) are used to~     treat various diseases such as epilepsy, insomnia, anxiety or movement disorders. However,~     the use of these medications is often compromised due to their side effects, like sedation,~     cognitive impairment, and addiction.~      Many of these side effects have been linked to a particular type of GABA receptor (GABA A~     alpha 1). Therefore, effort is being made to develop drugs that do not act on this receptor,~     but maintain their beneficial properties by acting on other types of GABA receptors. AZD7325~     is a drug that selectively acts on GABA A alpha 2 and A alpha 3 receptors, but not A alpha~     1. It has been tested in more than 700 people and so far proved to be generally well~     tolerated. Positron emission tomography (PET) study in humans demonstrated that AZD7325~     binds to GABA A receptors in the brain after a single dose. Early clinical studies have~     shown that it has less sedative and cognitive adverse events as compared with a~     benzodiazepine lorazepam.~      In this study, we will investigate its effects on short interval intracortical inhibition~     (SICI). SICI is neurophysiological marker of inhibitory processes in the motor cortex. It is~     obtained non-invasively by using transcranial magnetic stimulation (TMS). In TMS, magnetic~     impulses applied over the scalp that in turn induce a current in a small area of the brain.~     If applied over the motor areas of the brain, impulses result in muscle twitch that is~     recorded with surface electrodes. SICI is enhanced by certain drugs like benzodiazepines~     that act on GABA A alpha 1,2,3, and 5 receptor subtypes, but not by zolpidem acting solely~     on alpha 1 subtype. Because GABA A alpha 5 receptor subtype is less common in the cortex, it~     has been concluded that the drug effects on SICI are related to GABA A alpha 2 and alpha 3~     receptors.~      If AZD7325 proves to enhance SICI in healthy volunteers, this would create the grounds for~     the use of this medication to treat certain neurological disorders in which SICI has been~     found to be impaired (e.g., dystonia).~   "
70453|NCT02135185|"~     Improvement exercise tolerance~   "
70454|NCT02135172|"~     The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about~     2.9 million people in the UK currently have diabetes. There is increasing evidence~     suggesting that prolonged sedentary time may actually increase the risk of diabetes and~     other chronic diseases. Importantly, adults can meet public health guidelines on physical~     activity (150 minutes of moderate activity per week), but if they still sit for prolonged~     periods, their metabolic health is compromised. Going from sitting to standing and carrying~     out light-intensity activities (such as casual walking) may reduce diabetes risk. However,~     no one has investigated the effect of standing and walking on markers of cardio-metabolic~     markers in individuals with a high risk of T2DM. Therefore, the aim is to find out whether~     reducing the amount of time people spend sitting and replacing it with standing and light~     intensity activity (walking) reduces glucose, insulin and triglyceride levels, therefore~     reducing the risk of diabetes.~   "
70455|NCT02135159|"~     The purpose of this study is to determine the optimal sequences of combined trastuzumab~     emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from~     HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1~     pharmacokinetics.~   "
70456|NCT02135146|"~     The purpose of this study is to conduct a prospective, randomized, controlled trial~     comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients.~     Excessive perioperative fluid has been retrospectively implicated in the development~     postoperative acute lung injury (PALI) and pulmonary edema following lung resection.~     However, fluid restriction in these patients is not without risk and may compromise end~     organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid~     approach in thoracic surgery patients will result in better end organ perfusion with fewer~     occasions of acute kidney injury (AKI) without causing an increase in postoperative acute~     lung injury or pulmonary edema.~   "
70457|NCT02135133|"~     This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as~     a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia~     (SLL).~      The main purpose of this study is to examine the combination of the two drugs, Ofatumumab~     and Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously~     received treatment but do require treatment. The investigators hope to observe how~     participants' disease will be impacted by this treatment and whether they will benefit more~     from combining these drugs together rather than taking them separately. Both of these drugs~     have been used in treatment for CLL / SLL and information from those research studies~     suggests that these drugs may help patients with CLL/SLL.~      Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of~     CLL cells, which is expressed in CLL. An antibody is a molecule your body creates to~     identify foreign substances so that it can destroy them. Ofatumumab has been FDA approved~     for treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a~     drug that blocks one of the signals inside the cells that cause this type of cancer to grow~     and survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the~     growth of disease.~      In this research study, the investigators are evaluating the side effects of combining these~     two drugs, gathering information on the CLL/SLL disease process and how the study affects~     the patient's cells, as well as assessing the outcome of the disease. This combination of~     drugs has been previously tested, and appeared to be well tolerated.~   "
70458|NCT02135120|"~     The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its~     combination with peripheral nerve blocks (PNB) provides better analgesia for patients~     undergoing total knee arthroplasty (TKA).~   "
70459|NCT02135107|"~     The purpose of this study is to assess the efficacy and safety of E3810 10mg once and twice~     daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.~   "
70460|NCT02135094|"~     The purpose of this study is to measure the effectiveness of a wearable therapeutic~     ultrasound device for relief of pain associated with the trapezius muscle of the upper back~     over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers~     most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound~     device will lower the reported daily pain level of subjects suffering from trapezius muscle~     pain in their upper back.~      Subjects who participate in the study will self-administer the ultrasound device beginning~     at the onset of trapezius muscle pain, which is defined as a score of 3.0 or higher on a~     scale of 1-10. Subjects will be required to visit the clinical site at enrollment and weeks~     2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary.~      The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of~     joint contracture, relief of muscle spasm, and increased circulation.~   "
70461|NCT02135081|"~     This study seeks to determine cerebral blood flow changes in single ventricle patients~     during staged surgical reconstruction as compared with normal children. Two general groups~     of single ventricle patients will be recruited for this study, corresponding to the two~     approaches used. An aged-match group of healthy subjects will be included as a control.~   "
70463|NCT02135055|"~     ICU patients always experience all kinds of pain, discomfort and sleep~     disturbance,especially the sepsis patients. Appropriate sedation and analgesia is must,the~     newest sepsis guideline strongly recommend that mechanically ventilated sepsis patients need~     sedation therapy.~      Recent studies show than immune dysfunction dose have an important effect on the occurrence~     and development of sepsis. When the body suffer from the pathogenic microorganism attacking~     and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory~     anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS,~     the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed~     anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction.~     So, immune dysfunction is thought to be the key factors on the development of the sepsis.~     Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could~     suppress the inflammatory response effectively and then modulate the immune function.~      Several recent studies show that midazolam has the immunoregulation effect and trend of~     suppress the inflammatory response, but the result is controversy, the possibly reason is~     the different immune status. Now there is the guideline about the different immune status:~     the normal immune function means that the value of mHLA-DR is more than 15000 monoclonal~     antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range~     of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR~     is less than 5000 monoclonal antibody.~      The purpose of the study is to explore the effect of midazolam to inflammatory response and~     organ function at mechanically ventilated sepsis patients who have different immune status.~   "
70464|NCT02135042|"~     There are two study questions we are asking in this randomized phase II/III trial based on a~     blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally~     advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard~     concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if~     there is no detectable EBV DNA in their plasma, then patients are randomized to either~     standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still~     detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and~     fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high~     energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,~     fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil~     is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in~     treating patients with nasopharyngeal cancer.~   "
70465|NCT02135029|"~     This study is a multicenter, double blinded, active and placebo controlled randomized~     clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615;~     RN316) compared to placebo in subjects who are statin intolerant.~   "
70466|NCT02135016|"~     It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA~     with different block level on propofol concentration during general anesthesia induction.~   "
70467|NCT02135003|"~     Hypothesis 1: The proportion of pre-ART patients whose CD4 cell counts decline to~     ART-eligibility within 48 weeks will be lower in intervention compared to the~     non-intervention arm.~      Hypothesis 2: PLHIV who receive the PSCB intervention will experience lower rates of~     morbidity or death over the follow-up period compared to patients not receiving the~     intervention~      Hypothesis 3: PLHIV who receive the PCSB intervention will have better adherence to~     scheduled clinic appointments compared to those not receiving the intervention~   "
70468|NCT02134990|"~     The study will be a prospective open-label single-center study in previously treated~     patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the~     combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated.~      Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be~     evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi~     D and Oshadi R.~      CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3~     Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be~     considered or subsequent therapy.~   "
70469|NCT02134977|"~     The purpose of this survey is to examine the effect on quality of life (QOL) improvement and~     convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg)~     injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a~     luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in~     premenopausal breast cancer participants in daily medical practice. Influence of condition~     of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25~     mg injection kit was also evaluated.~   "
70470|NCT02134964|"~     This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy~     volunteers after administration of single or multiple dose(s) of investigational drug~     (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts,~     and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.~   "
70471|NCT02134951|"~     The purpose of this study is to assess the relative feasibility of 2 potential functional~     measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in~     drug development for psychotic spectrum disorders.~   "
70472|NCT02134938|"~     The purpose of this study is to assess whether low caloric, low energy density, konjac food~     products are effective in appetite regulation when administered as caloric replacements. It~     is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food~     products will have comparable satiety scores, decreased postprandial glucose response, and~     will not significantly affect subsequent food intake.~   "
70473|NCT02134925|"~     This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant~     vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous~     polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer~     over time. Vaccines made from peptides may help the body build an effective immune response~     to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence~     of adenomatous polyps and may prevent the development of colorectal cancer.~   "
84354|NCT01953263|"~     This study is designed to evaluate the safety of autologous muscle fiber fragments for the~     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).~   "
70474|NCT02134912|"~     This randomized phase II trial studies how well pemetrexed disodium with or without~     crizotinib works in treating patients with stage IV non-small cell lung cancer that has~     progressed after crizotinib. Drugs used in chemotherapy, such as pemetrexed disodium, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Crizotinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether giving pemetrexed disodium is more effective with or without crizotinib in~     treating patients with non-small cell lung cancer that has progressed after crizotinib.~   "
70475|NCT02134899|"~     The investigators multicenter randomized open-labelled study will investigate the efficacy~     of an everolimus based immunosuppression in reducing total native kidney volume in kidney~     recipients with autosomal dominant polycystic kidney disease compared to a calcineurin~     inhibitor-based immunosuppression.~   "
70476|NCT02134886|"~     This phase I trial studies the side effects and best dose of erlotinib hydrochloride in~     treating non-small cell lung cancer that has spread to other parts of the body or cannot be~     removed by surgery in patients with human immunodeficiency virus (HIV) infection. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Erlotinib hydrochloride is a standard drug used for treating lung cancer,~     however, it is not yet known whether it is safe to give erlotinib hydrochloride to patients~     who also have HIV infection or not.~   "
70477|NCT02134873|"~     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,~     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for~     reducing pain during invasive procedures and is a standard of care for painful procedures.~     The purpose of this study is to see what is the least amount of sucrose that can be given to~     a baby to reduce pain during procedures.~   "
70478|NCT02134860|"~     Bed rest produces insulin resistance in healthy volunteers. In this study the investigators~     aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate~     daily fasting affects cognitive function and the insulin resistance produced by bed rest.~      The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily~     fasting or one meal/day every second day (25% of daily calorie need) and four meals/day~     every second (175% of daily calorie need).~      The investigators hypothesize:~        1. Bed rest reduces the incretin effect~        2. Alternate daily fasting improves the cognitive function (memory and concentration)~          compared to isocaloric diet~        3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to~          isocaloric diet~   "
70479|NCT02134847|"~     In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on~     the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety;~     and 2) the lack of data on the relationship between resident sleep deprivation and~     preventable patient injuries. Through the Clinical and Translational Science Award~     (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science~     network in the U.S., we propose conducting a multi-center randomized crossover trial in six~     pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious~     errors (i.e., rates of harmful and other serious medical errors due to any cause, including~     but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits)~     of a sleep and circadian science-based (SCS) intervention schedule with a traditional~     schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:~        1. To test the hypothesis that PGY2&3 residents working on an SCS intervention schedule~          will make significantly fewer harmful medical errors (preventable adverse events) and~          other serious medical errors (near misses) while caring for ICU patients than residents~          working on a traditional schedule; (primary endpoints: resident-related preventable~          adverse events and near misses)~        2. To test the hypothesis that rates of harmful medical errors (preventable adverse~          events) and other serious medical errors (near misses) throughout the ICU (i.e., those~          involving and those not involving residents) will be lower in ICUs when PGY2&3~          residents work on an SCS intervention schedule than when residents work on a~          traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events~          and near misses)~        3. To test the hypothesis that resident physicians' risk of neurobehavioral performance~          failures and motor vehicle crashes - as assessed through simple visual reaction time~          tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will~          be lower on the SCS intervention schedule than on the traditional schedule. (major~          secondary endpoints: resident neurobehavioral performance and predicted driving safety)~   "
70480|NCT02134834|"~     The objectives of this study are to assess the safety, tolerability and pharmacokinetic~     profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at~     single escalating doses.~   "
70481|NCT02134821|"~     Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.~   "
70482|NCT02134808|"~     The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for~     eight weeks will be associated with significant increases in frontal lobe phosphocreatine~     and beta-nucleoside triphosphate (β-NTP) concentrations. A secondary hypothesis is that~     decreased depressive symptoms measured with the Children's Depression Rating Scale-Revised~     (CDRS-R) and Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally~     correlated with increased β-NTP concentrations.~   "
70483|NCT02134795|"~     This is a single-center, unblinded trial without placebo control to evaluate the acute~     effects of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease~     patients.~   "
70484|NCT02134782|"~     Fatigue is a major problem in children, adolescents and adults receiving intensive~     chemotherapy for cancer and in patients undergoing hematopoietic stem cell transplantation~     (HSCT). Guidelines from the National Comprehensive Cancer Network suggest that all patients,~     including children as young as 5 years of age, should be routinely screened for fatigue at~     the initial visit and at regular intervals throughout and following anti-cancer treatment.~     These guidelines also suggest that fatigue should be managed according to clinical practice~     guidelines. However, evidence demonstrating effective interventions for fatigue in children~     with cancer is scarce. Exercise is an effective intervention for cancer-related fatigue in~     patients of all ages. However, patients receiving the most intensive treatments may be too~     ill to participate in a standardized exercise program. A unique and potentially effective~     intervention that combines exercise and relaxation is yoga. This randomized controlled trial~     (RCT) will determine whether a 3 week program of individualized yoga is associated with less~     fatigue, better quality of life (QoL) and less systemic opioid use compared to the control~     program of an Apple tablet (iPad) games, music, movies or books. This is a multi-center,~     parallel-group, randomized trial of individualized yoga for fatigue. Subjects are inpatients~     8-18 years of age receiving intensive chemotherapy for cancer or undergoing HSCT who are~     expected to remain in hospital for 3 weeks. Participants will be randomized to the~     individualized yoga program or to the iPad activity control program. For those who remain~     hospitalized on day 21, the alternate intervention will be offered for 1 week and the~     preferred strategy will be determined. Yoga has the potential to significantly reduce~     fatigue, a prevalent and distressing symptom, in children with cancer and HSCT. The~     investigators have assembled the optimal team with the expertise and track record to~     accomplish this important trial. This trial is an incremental and critically important step~     in a program of research designed to improve health for children at the highest risk for~     poor quality of life. Results may have broad applicability to other hospitalized pediatric~     populations and has the potential to change in-hospital care for these patients.~   "
71090|NCT02126852|"~     This study evaluates three different neuromuscular monitoring devices (acceleromyography,~     one- or three-dimensional, and electromyography) with regard to their precision to detect~     residual paralysis after injection of neuromuscular blocking agents and recurrence of~     paralysis after administration of reversal agents in a clinical setting.~   "
70488|NCT02134730|"~     Mental illness is a major health problem in children and young people, and there is evidence~     that mental illness is increasing among young people in the population. More than 80 % of~     the cost to society of mental illness in children in Sweden is the cost of treatment and~     care.~      Anxiety and depression are the most common psychiatric problems in children and adolescents.~      In comparison with the treatment of mental disorders, there is relatively limited knowledge~     about prevention. There are at least two very important reasons to investigate further~     preventive interventions for anxiety and depression. (1) Only about 20% of children and~     adolescents with anxiety or depression use health services. (2) Some children stop treatment~     and almost 40% do still fulfill criteria for the disorder after treatment.~      FRIENDS for life is one of the most evaluated prevention programs internationally. The~     program has shown promising results in research. The overall aim of the present study is to~     evaluate FRIENDS for Life in Sweden.~   "
70489|NCT02134717|"~     The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish~     inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first~     undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline~     analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then~     undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for~     analysis following maraviroc treatment.~   "
70490|NCT02134704|"~     The hypothesis of this study is that moderate scoliosis patients have postural and kinematic~     differences (static and dynamic) compared with healthy volunteers and it is possible to~     characterize and quantify.~      The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis~     patients compared with healthy volunteers~   "
70491|NCT02134691|"~     This project will examine the impact of PE therapy for the treatment of PTSD with a sample~     of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is~     critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under~     detected and under treated condition. Untreated PTSD has a substantial impact on health,~     functioning and quality of life. PE is one of the most empirically supported psychological~     interventions for PTSD. However, most studies that evidence the efficacy of PE have been~     conducted mainly with English-speaking Caucasian populations. This study has the potential~     to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.~   "
70492|NCT02134678|"~     This study will compare mechanisms of action in two forms of brief psychotherapy for major~     depressive disorder in adults. A treatment that targets deficits in motivation in depression~     is expected to show greater improvements in motivation and pursuit of personal goals~     compared to a second treatment that targets irrational thoughts that are typical in~     depression.~   "
70493|NCT02134665|"~     The purpose of this study was to evaluate the influence of severe acute pancreatitis on the~     serum level of vancomycin, a glycopeptide antibacterial agent.~   "
70494|NCT02134652|"~     The purpose of this study is determine the ability of bedide ultrasound performed in the~     Emergency Department and Outpatient Department can predict the severity of disease during a~     Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the~     presence of gallbladder wall thickening and/or pleural effusions in children correlates with~     progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that~     sonographic imaging of pediatric patients presenting to the emergency department with a~     fever during a Dengue fever outbreak will change management and disposition.~   "
70495|NCT02134639|"~     Through the investigators involvement in an international consortium, the investigators had~     the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers.~     The investigators propose in this project to develop on their site, the radiosynthesis of~     68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared~     with the current imaging OctreoScan®. The objectives of this project are: - to validate the~     radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically~     evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with~     68Ga-DOTATOC in comparison with other standard imaging examinations.~   "
70496|NCT02134626|"~     It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are~     going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at~     echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that~     simvastatin can lower portal pressure.~   "
70497|NCT02134613|"~     Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is~     effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory~     articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the~     joint or skin in these patients may help in guiding the course of treatment more~     efficiently. The investigators research group has developed a novel approach to label~     anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with~     scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α~     scintigraphy might recognize the molecule involved in the inflammatory process and provide~     crucial information to help physicians taking decisions about the drugs to be used based on~     biological evidence and which are cost-effective and appropriate for the treatment of~     choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the~     articular joints and skin while it also ensures that the drug has reached its therapeutic~     target. It also allows correlation between the presence of the drug and clinical responses.~   "
70498|NCT02134600|"~     The purpose of this study is to find an optimal dose of omega-3 that can be given to~     children who have completed cancer therapy. The future aim is to add omega-3 to conventional~     cancer treatment modalities and thereby hopefully increase the treatment efficacy, which~     will have to be addressed in subsequent phase-2 studies.~   "
70509|NCT02134457|"~     This study is designed as an exploratory study to assess safety and efficacy of two~     different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of~     infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the~     treatment of ROP and provide explorative data on long-term effects of ranibizumab after~     intravitreal injection in neonates.~      The primary objective is to assess clinical efficacy of ranibizumab in children with ROP~   "
71091|NCT02126839|"~     The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared~     to placebo in pediatric participants with asthma.~   "
70499|NCT02134587|"~     Spontaneous reports by health professionals generate the signals in pharmacovigilance.~     However, the passive method has limitations and the most important of them are the~     underreporting and the poor quality of data, hindering the causality assessment of adverse~     drug events (ADE). Therefore, the present study aimed to validate an educational~     intervention (EI) in pharmacovigilance for hospital health professionals, in order to~     analyze the impact on the knowledge, skill and attitude in ADE reporting.~      Investigators proposed a multifaceted EI which will be developed in four meetings with one~     hour each. The following activities will be carried out: application of a questionnaire to~     assess the knowledge, skill and attitude before and after EI; lecture; practical class and~     education material distribution. The answers of questionnaire are going to be analyzed using~     content analysis technique. The definitions of World Health Organization and the minimum and~     desired criteria to fill the ADE form, according to the Pan American Health Organization,~     are going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann~     Whitney test for paired samples will be applied, in order to assess the impact of~     educational intervention on behavior of health professionals (ADE reporting).~      With the present study, the following hypotheses will be tested:~      H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before~     and after the educational intervention.~      H1= The numbers of ADE reported before and after the educational intervention are different.~   "
70500|NCT02134574|"~     Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.~   "
70501|NCT02134561|"~     The purpose of this study is to assess the psychological, cognitive and social resources of~     applicants for Huntington's Disease and Presymptomatic Testing.~   "
70502|NCT02134548|"~     This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test~     versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.~      The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of~     Chagas infection in patients. This test is intended to be used on human whole blood or serum~     samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing~     with a reference standard test.~      Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed~     consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will~     be collected. One is blood from finger prick, and the other is blood from venous puncture~     (drawn from vein in arm).~      Rapid tests and reference tests will be performed by different operators who are laboratory~     staff members. These staff members, blinded to each other's results, will evaluate the~     samples from each method independently.~   "
70503|NCT02134535|"~     The overall purpose of this research study is to collect vaginal and cervical biopsies from~     healthy HIV negative participants. These samples will enable investigators to optimize~     laboratory methods and explore implementation challenges associated with the ex vivo~     challenge model. The first objective is to assess which HIV virus is best for use in the~     model. The second objective is to determine the best endpoint for the assay.~      The primary aim of this study is to collect an adequate number of cervical and vaginal~     biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge~     model has been and will continue to be used in topical microbicide clinical trials to~     predict the efficacy of candidate drugs.~   "
70504|NCT02134522|"~     The purpose of this study is to examine whether CPAP therapy can reduce or eliminate hepatic~     fat accumulation in obese children and adolescents.~   "
70505|NCT02134509|"~     The purpose of this study is to test the effectiveness of a smartphone application for~     smoking cessation in smokers ages 18 to 65 years.~   "
70506|NCT02134496|"~     The study investigates the safety of discharge from the Post-Anesthesia Care Unit (PACU)~     without assessment of motorfunction after spinal anesthesia for total hip- or knee~     replacement. This is an randomized controlled trial between two groups with assessment of~     normal (Aldrete) PACU discharge criteria with or without assessment of the motorfunction.~     The study hypothesis is that it is safe to be discharged from the PACU to a ward without~     assessment of motor function.~      The main outcome is length of hospial stay (LOS) in days and re-admission within the first~     30 days after surgery .~      Secondary outcomes include adverse events up to 24 hours after surgery, and minuttes spent~     in the PACU after surgery.~      Participants will be monitores for adverse events for the first 24 hours after surgery and~     reported. The total number of minuttes spent in the PACU will be recorded and reported.~   "
70507|NCT02134483|"~     Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of~     permanent hypoparathyroidism. However, it is a difficult process that requires a number of~     trained staff and advanced laboratory equipment which bring high costs. In this study, we~     have identified a new PA-t technique.~   "
70508|NCT02134470|"~     It is generally accepted that chemical testing of biologic fluids is the most objective~     means of diagnosis of drug use. In recent years saliva has attracted much attention. The~     prime advantage of saliva is that it offers non-invasive, stress-free and real-time repeated~     sampling whereas blood collection is undesirable, difficult and expensive. In addition, it~     is known that androgens such as testosterone can be assayed in saliva, as these steroids~     pass the endothelial-epithelial barriers by passive diffusion. Nevertheless, the~     correlations of blood, urine and saliva concentrations are not well documented. In recent~     reviews, it is pointed out that salivary hormone analysis could be a promising method for~     sports medicine and doping control, but much work is needed before the use of saliva samples~     in this area receives the acceptance. According to recent studies the increase of~     testosterone concentration in saliva is significantly higher than alterations of steroid~     concentrations (or ratios) in blood or urine. Saliva concentration may therefore serve as~     screening parameter to select suspicious cases for further target evaluation (e.g. by IRMS).~     This may be beneficial to identify cases of transdermal administration of low steroid doses.~     It is therefore the aim of the present project to detect administered testosterone in saliva~     and compare these levels to those in blood and urine. The intention is not to detect high~     dosage but low dosage abuse of testosterone, as a single-dose by patch application. From the~     practical point of view saliva could offer a complementary specimen for a pre-screening of~     testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or~     urine levels. So the present study could be the base for a new method to preselect the~     suspicious samples for testosterone abuse.~   "
84355|NCT01953250|"~     Questionnaire To assess the functional outcome in patients that underwent laparoscopic~     sigmoid and/or rectum resection.~   "
70510|NCT02134444|"~     Study Description and Purpose:~      The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith~     end organs. These organs contain specialized gravito-inertial sensors that sense angular and~     linear head acceleration. The input from these sensors is required to stabilize gaze~     position during head motion, and provide an absolute frame of reference with respect to~     gravity, thus providing a vertical spatial reference for body orientation and balance.~     Disease or damage of the vestibular sense organs causes a range of distressing symptoms and~     functional problems for people that could include loss of balance, gaze instability,~     disorientation and dizziness. A novel computer based rehabilitation system with therapeutic~     gaming application has been developed. This method allows different gaze and head movement~     exercises to be coupled to a wide range of inexpensive, commercial computer games. It can be~     used in standing and thus graded balance demands using a sponge pad can be incorporated into~     the program.~      Study Objective:~        1. Test the therapeutic effectiveness of the TRP delivered in the home compared to usual~          care delivered in an out-patient physical therapy clinic on measures of balance~          (standing and walking) , gaze control, dizziness, and health related quality of life in~          individuals with peripheral vestibular disorders.~        2. Compare trajectory of change in electronic gaze performance measures obtained during~          each therapy session of each participant assigned to the home Telerehabilitation.~      Hypothesis:~      Investigators believe the Telerehabilitation platform to be a cost-effective delivery of~     rehabilitation. Additionally motivation to perform tedious home programs can be improved~     with engaging, fun and interactive computer gaming as part of the rehabilitation process. It~     is hypothesized the home game-based Telerehabilitation program will result in greater~     improvements in dynamic balance control, gaze control, and dizziness, in individuals with~     peripheral vestibular disorders as compared to a typical out-patient physical therapy~     regimen.~   "
70511|NCT02134431|"~     Microbicides are topical medicines that can prevent infection by Human Immunodeficiency~     Virus (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is~     becoming infected with HIV all over the world. From past research, we know that at different~     ages people experience age-related changes in their bodies that can cause differences in how~     they process medications. In this study, gut tissue samples (or gut biopsies) from 12~     HIV-negative volunteers will be collected. These pieces of tissue will be infected with HIV~     in the laboratory to develop a model that can be used to test certain drugs against the HIV~     infection. We can use this tissue to test a drug called tenofovir against HIV infection. We~     will determine whether this drug can decrease HIV infection in the gut biopsies. In this~     study, we will also measure HIV levels and the levels of tenofovir in gut and blood samples~     in 12 people who are already taking this drug. This information can determine whether levels~     of drug found in the gut can protect it from HIV. The results can be compared to other age~     groups of adolescents and adults. Subjects will undergo a common procedure called a lower~     endoscopy (this can be a colonoscopy or a flexible sigmoidoscopy) to obtain gut biopsy~     samples.~      The central hypothesis is that tissue drug profiles of tenofovir (TFV) and its active~     component, tenofovir disoproxil fumarate (TDF), and tissue infectibility vary between~     younger (10-14 years old) versus older adolescents (18-21 years old), and that both differ~     from adults (>21 years). Specifically, younger HIV positive adolescents will have lower~     levels of tissue tenofovir compared to older HIV positive adolescents and adults in an~     age-dependent manner. Additionally, biopsies from younger HIV negative adolescents will~     have: 1) higher rates of infection compared to biopsies from older HIV negative adolescents~     infected with a lower dose of virus; and 2) lower percent suppression of tissue infectivity~     compared to biopsies from older HIV negative adolescents using low dose tenofovir.~   "
70512|NCT02134418|"~     Intervention aimed at improving understanding of irony in social situations by using movies~     and comic strip will improve theory of mind.~   "
70513|NCT02134405|"~     This is a multi-Asian-centre randomised controlled trial of Rebamipide alone vs Rebamipide~     with Esomeprazole in the treatment of adult patients with Functional Dyspepsia. The~     hypothesis is that a combination therapy is superior to mono-therapy in the control of~     patients' symptoms and quality of life improvement.~   "
70514|NCT02134392|"~     C-diff infection often causes belly pain and diarrhea and can be very hard to treat with~     medicine. One of the possible reasons that C-diff infection is hard to treat is because~     there is too much bad bacteria in the colon. Investigators believe that putting more~     good bacteria into the colon will help fight the bad bacteria. We do this by doing a~     fecal (poop) transplant.~      Fecal transplant has been done at other hospitals, but not at Nationwide Children's~     Hospital. Since our Investigators have not done this before, this study will help us learn~     the best way to do the transplant. Investigators also believe this transplant might help~     improve symptoms for patients with C-diff.~   "
70515|NCT02134379|"~     This pilot study proposes to perform measurements of approved thoracic impedance technology~     that will help answer questions in patients with decompensated heart failure.~   "
70516|NCT02134366|"~     The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more~     effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC)~     than either lorazepam and/or clonazepam.~   "
70517|NCT02134353|"~     This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400~     mg b.i.d. in subjects aged 18 years and above.~      We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from~     baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects~     with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however,~     this trial has set a threshold of 80 mL for the purposes of determining an appropriate~     sample size for statistical power while retaining trial feasibility in an orphan disease~     population~   "
70518|NCT02134340|"~     The purpose of the study is to evaluate the safety and biodistribution of [I-124]-CPD-1028~     Injection in cancer patients with solid tumours.~   "
70519|NCT02134327|"~     Following an obtained written consent, a child presenting for ear tube surgery will be~     randomized into one of three groups for receiving a premedication. One group will be the~     current therapy with midazolam, another group will be another drug dexmedetomidine, and the~     third group will be a combination of midazolam plus dexmedetomidine. Observers in the study~     (the investigators fellow and advance practice nurse) will not know which group each patient~     belongs, and will then make three separate assessments: preoperative sedation, mask~     acceptance, and postoperative delirium.~      Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to~     fall asleep and lose consciousness, involves placing a mask over there face, specifically~     the nose and mouth. The mask is connected to their anesthesia machine via tubing, or a~     circuit, through which their anesthetic gases flow. Some children fight the mask as it can~     be seen as new and frightening. Other children, sometimes depending on how sedated they are~     after receiving a premedication, do not fear the mask on their face and do not resist~     induction. How well or easily this happens can be described as mask acceptance.~     Postoperative delirium can be seen in patients of any age or after any surgery and can be~     better defined as a mental disturbance during the recovery from general anesthesia~     consisting of hallucinations, delusions, and confusion manifested by moaning, restlessness,~     involuntary physical activity, and thrashing about in bed. It has been considered a common~     postanesthetic problem in children and adults since 1960.~      Each patient will then have a set of numbers for each scale; following conclusion of the~     study the investigators will be able see which drug each patient received and statistical~     analysis can be completed. The investigators goal is to see if there is any difference in~     any of the scales depending which medication was administered. The scales to be utilized~     include the pre-operative sedation scale, the mask acceptance scale, and the pediatric~     emergence delirium scale.~   "
70520|NCT02134314|"~     The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with~     high risk for delayed graft function (DGF) may show significant improvement in outcomes post~     transplant compared with patients that do not receive C1INH treatment. Complement activation~     has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI)~     and inflammatory cell infiltrates. By blocking complement activation the investigators hope~     to improve kidney graft function post transplant in these recipients.~   "
70521|NCT02134301|"~     The purpose of this Phase 1 trial is to evaluate the PK, safety and tolerability of~     oritavancin in patients <18 years old with a confirmed or suspected bacterial infection.~   "
70526|NCT02134223|"~     Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with~     considerable morbidity, mortality, and high rates of medical and psychiatric utilization~     services. Research focusing on finding a biological observable marker for the purpose of~     monitoring treatment effects has started to draw attention. Recent research has implicated~     that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological~     correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD~     patients compared to general population, or pre- and post- psychotherapeutic treatment might~     indicate the consequence of epigenetic modification associated with stressful experience or~     suicide, and may later be able to explain the psychopathology or neuro-development of BPD.~      Method: The investigators therefore propose this current randomized control trial to test~     whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions~     having suicide or non-suicidal self injurious behaviors will be followed and tested against~     changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including~     suicidality, depression, hopelessness, quality of life, disability, service utilization, and~     function.~      In the first to third years of this study, the investigators will aim to recruit 180 study~     and control subjects, to gather information, to collect biological samples, to give out~     one-year of psychotherapy per subject, to evaluate results before, during, and after~     treatment. In addition, the investigators also hope to explore the effects of known or~     unknown drugs associated with the change of DNA methylation at cell level.~      Hypothesis:~      Responders of participants who receive DBT will show greater decrease in BDNF methylation~     levels than patients receiving TAU.~   "
70527|NCT02134210|"~     This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO~     who have not yet received any biologic therapy for any indication (other than insulin or~     hormones).~   "
70528|NCT02134197|"~     The purpose of this study is to evaluate:~        -  The side effects of BAY1129980 when given every 21 days different dose levels.~        -  Determine the dose level of BAY1129980 that should be tested in future clinical~          research studies.~        -  Measure how much BAY1129980 is in the blood at specific times after administration.~        -  If treatment with BAY1129980 shows any effect on reducing the tumor growth.~        -  If there are specific biomarkers that might be able to explain why some patients~          respond to treatment and others do not.~        -  If treatment with BAY1129980 causes an immune response from the body against the drug~          (immunogenicity).~   "
70529|NCT02134184|"~     In this study we are trying to understand whether previous infection with a particular~     virus, namely cytomegalovirus (CMV), influences the ability of the immune system to respond~     to new infections or vaccinations with age.~   "
70530|NCT02134171|"~     The aim of this study is to determine the frequency of cardiac and cerebral involvements in~     patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be~     assessed for cardiac involvement (troponin Ic level and cardiac ultrasonography) and~     cerebral involvement (cerebral MRI). The investigators will assess whether serum troponin Ic~     on diagnosis can predict morbidity and mortality of patients with a thrombotic~     microangiopathy at the acute phase.~      The primary outcome measurement is the event free survival at day 30, as defined by death,~     myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An~     increase in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among~     the three daily analyses performed after TMA diagnosis.~   "
70531|NCT02134158|"~     The aim of this trial is to quantify the improvement of locomotion and equilibrium induced~     par tDCS in anode polarity position in post stroke hemiplegic patients.~   "
70532|NCT02134145|"~     There is a great need within healthcare to develop systems of care that better engage and~     activate people in their own care before they become patients. By so doing lay users will be~     empowered to take charge of their own care in recognizing they can change their health and~     improve their quality of life. Mobile health technologies such as the Scanadu ScoutTM hold~     the potential to truly engage individuals in the way needed through real-time data capture,~     transmission and connectivity.~      We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of~     self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu~     Scout™, through a prospective observational study. Using validated survey tools and through~     the remote tracking of frequency of use and physiological measurements from the Scanadu~     Scout™ device and app.~      Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.~      Participants will be instructed to use the Scanadu Scout™ as much as they would like. The~     parameters that will be functional on the device and available for measurement by the~     participant are:~        -  Heart rate~        -  Respiratory rate~        -  Temperature~        -  Oxygen saturation~        -  Heart rate variability~        -  Blood pressure~      Data analysis will examine individual participant and aggregate level:~        1. Usage and physiologic measurement data of the device,~        2. Perceptions of the device, and~        3. Changes in self-reported health self-management, health-related quality of life,~          participant- physician communication and medication adherence between baseline and~          follow-up.~   "
70533|NCT02134132|"~     Diabetes is a multiorgan disease and considered a major health problem in different~     societies. One of the complications the pain particularly in the extremities resulting from~     a process known as diabetic foot ulcer. The diabetic patients are subjected to many~     complications because of foot ulcers, many of them like as chronic wound disease or pressure~     ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to~     nursing care and take too long until pain relief. Among many tested materials and works for~     wound healing such as debridement, tissue oxygenation, and skin transplantation,~     platelet-derived compounds are allocated the pivotal position between investigators to~     tissue regeneration and shortening the wound healing process.~      Many of platelet components are procured from platelet rich plasma (PRP) from whole blood~     donation. Furthermore, it requires to an additional purification step to diminish the volume~     and facilitate handling in some studies. It means that platelet concentrates (PCs) may be~     obtained leading to more concentrated platelets in lower volume.~      Two types of granules in platelet is responsible for storage of many useful and different~     growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the~     ability to growth and differentiation of numerous cells. Also, the antibacterial effect of~     these growth factors has been reported.~      To better efficacy and comfortable utilization of platelet, it is feasible to form the~     platelet gel and then apply on wound sites.~      This study is a double blind randomized controlled trial to evaluate the positive effects of~     umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.~   "
71111|NCT02126579|"~     The purpose of this study is to learn what effects (good and bad) an experimental vaccine~     (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide~     ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine~     and these drugs cause any changes in your immune system.~   "
70534|NCT02134119|"~     The purpose of this study was three-fold. We wanted to (1) determine if supplementation with~     an echinacea-based dietary supplement (ECH) would increase several blood parameters that~     could affect oxygen carrying capacity in the body, (2) determine if ECH would increase~     VO2max in trained endurance athletes, and (3) examine the effectiveness of two different~     doses of the ECH on all outcome variables. We hypothesized that supplementation with ECH~     would increase oxygen carrying capacity (as measured by RBCs, EPO, ferritin, hemoglobin~     (Hb), and hematocrit (Hct) levels), improve VO2max, and that the maximum dose would be most~     effective at increasing these outcomes.~   "
70535|NCT02134106|"~     Background and rationale:~      Antimicrobial resistance is a global public health threat. An increasing number of~     Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics~     including carbapenems. Although polymyxins are the current gold standard antibiotic for~     treatment of severe extensively drug-resistant Gram-negative bacteria (XDR-GNB - defined in~     Appendix I) infections, resistance development on therapy and treatment failures are common.~     Combination antibiotics therapy have better in vitro efficacy, but have not been formally~     tested in a prospective trial.~      We will conduct a Phase IIB, prospective, open-label, randomized-controlled trial in 4 major~     Singaporean hospitals, with balanced treatment assignments achieved by permuted block~     randomization, stratified by hospital. There will be 75 subjects per arm, with the subjects~     in the comparator arm receiving standard-dose polymyxin B while the intervention arm will~     receive a second antibiotic, doripenem, with polymyxin B against the bacterial isolate in~     question. Subjects with ventilator-associated pneumonia (VAP) will additionally receive~     nebulized colistin. The primary outcome is 30-day mortality while secondary outcomes include~     microbiological clearance, time to defervescence, and toxicity of therapy, presence of~     secondary infections due to new multi-drug resistant bacteria and length of ICU stay. Plasma~     drug levels will be measured by liquid chromatography-mass spectrometry.~      Hypothesis:~      The underlying primary hypothesis is that combination antibiotic therapy (IV polymyxin B +~     IV doripenem) is superior to mono-antibiotics therapy (IV polymyxin B) in reducing 30-day~     mortality from XDR-GNB infections.~   "
70536|NCT02134093|"~     This study is to explore the effects of dexmedetomidine on postoperative cognitive~     dysfunction during one-lung ventilation in elder patients.~   "
70537|NCT02134080|"~     The purpose of this trial is to examine the safety, tolerability and feasibility in the use~     of a FAAH inhibitor for the treatment of adults with Tourette syndrome.~   "
70538|NCT02134067|"~     The purpose of this study is to determine the safety of TAS-119 and determine the most~     appropriate dose in combination with Paclitaxel for subsequent studies in patients with~     advanced solid tumors.~      TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been~     demonstrated to enhance the activity of paclitaxel in preclinical studies~   "
70539|NCT02134054|"~     In this cross sectional and longitudinal study, patients with inflammatory bowel disease on~     biological treatment with infliximab or adalimumab will be included.~      After inclusion, the dosage of their existing biological therapy will be adjusted following~     regular trough-level and antibody-level monitoring, according to a treatment algorithm.~      Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis~     is that therapeutic drug monitoring may improve clinical disease outcome after one year of~     follow-up.~   "
70540|NCT02134041|"~     We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database~     which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI~     (mTBI) participants who have ever been registered in the database. This database has been~     established for over 15 years and contains the information of over 150000 patients. It is~     one of the largest TBI database in the world.~      TBI usually results from traffic accidents, falls or violence events. Most of the victims~     are young people and the victims suffer from life-threatening and mental-physical deficits.~     Mild TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI~     patients usually were not obtained enough initial treatment. Therefore, mTBI might result in~     long-term cognitive and affective impairments, such as depression, indifference, anxiety,~     memory impairment, loss of attention and executive function. These late effects not only~     decrease the life quality of patients and their family but also increase the social and~     medical burden.~      Recent epidemiology studies have pointed out that TBI would increase the risk for dementia,~     especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI~     severity, number of repeats, genetic factors and onset of AD remains further investigation.~      Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD.~     Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling~     researches have supported TBI accelerates the formation and accumulation of Aβ. These~     findings could link TBI with AD but the previous researches had limitations. There was lack~     of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By~     amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool~     could be helpful for understanding the real impacts and pathophysiological mechanisms of~     mTBI on AD.~   "
70541|NCT02134028|"~     Primary Objective:~      Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who~     participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).~      Secondary Objectives:~      Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous~     dupilumab asthma clinical study.~      Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma~     clinical study, with regards to:~        -  Systemic exposure~        -  Anti-drug antibodies~        -  Biomarkers~   "
70542|NCT02134015|"~     1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free~          survival will be the primary outcome. Subjects will need to have Epidermal Growth~          Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their~          cancer progressed after at least one prior systemic anti-cancer therapy, available~          recent or archival tumor specimen and may not have had previous EGFR-targeted regimen,~          anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy.~          Subjects may have high heregulin or low heregulin.~        2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival~          will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance~          or metastatic NSCLC and have their cancer progressed after at least one prior systemic~          anti-cancer therapy, available recent or archival tumor specimen and may not have had~          previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only~          subjects with high heregulin will be enrolled.~   "
71092|NCT02126826|"~     -  To investigate the safety and tolerability of BI 1026706 in male and female healthy~          subjects and osteoarthritis (OA) patients following oral administration of repeated~          rising doses~        -  To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and~          female healthy subjects and OA patients~        -  The assessment of pharmacodynamics in OA patients~   "
70543|NCT02134002|"~     This study represents a randomized, double blind placebo-controlled trial. Thirty cocaine~     dependant patients will be included in this study during their hospitalization for~     withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250~     mg/day or placebo over the 15 days of their hospitalization. Main outcome criteria will be~     evaluated during two TEP imaging sessions with 11Craclopride, before and after stimulation~     by methylphenidate, 8 to 15 days after randomization.~   "
70544|NCT02133989|"~     The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko~     biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery~     stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior~     than clopidogrel in terms of post-stent ischemic lesions in these patients without serious~     complications.~   "
70545|NCT02133976|"~     Psychosocial interventions are attractive options for treating chronic low back pain, and~     many approaches now have strong support for efficacy. However, few empirical data address~     whether psychosocial pain treatments work because of mechanisms specified by theory, and~     thus investigators know very little about HOW our treatments work. It may be that different~     treatments work via distinct pathways that are specific to a given treatment (single effect~     model), or it may be that different treatments work to the extent they all operate via key~     mechanisms that they share (additive effects model). Examination of specific and/or shared~     effects on outcomes of mechanisms will provide theoretical and empirical rationale for~     enhancing procedures and techniques most closely linked to strong outcomes and incorporating~     them into future interventions, while limiting the use of others that may be revealed as~     inert.~   "
70546|NCT02133963|"~     Psychosocial factors, including a previous history of depression, recent stressful life~     events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy~     have been shown to be associated with an increased risk for the development of postpartum~     depression (PPD). Biological mechanisms underlying the relationships among these~     psychosocial risk factors for PPD, and the development of PPD, remain unclear. However,~     evidence from non-perinatal populations suggest that dysregulation in stress-reactive~     neuroendocrine factors may play a role. The primary objectives of this study are: (1) to~     assess the feasibility of enrolling second trimester pregnant women, with or without~     depression histories, into a laboratory-based study protocol which includes a mild~     psychosocial stressor and the collection of venous blood for the measurement of~     stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the~     feasibility of retaining participants, for a brief postpartum phone interview, after~     completion of the second trimester assessments; and (3) to establish proof of concept for~     measuring group differences, between women with or without depression histories, in second~     trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious~     symptoms, recent stressful life events, and sleep quality.~   "
70547|NCT02133950|"~     A single centre observational study into the segmentation of preimplantation genetic~     diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation~     of all genetically transferable embryos after PGD, compared to fresh embryo transfer~     cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim~     of the study is to assess the feasibility and effectiveness of segmentation in terms of~     pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in~     PGD cycles.~      Experimental questions~        1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically~          transferable embryos are cryopreserved by vitrification prior to consecutive in utero~          transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer~          cumulative with transfer of supernumerary cryopreserved embryos?~        2. Does the technique of segmentation allow better planning of DNA amplification and~          genetic analysis?~      Design The proposed design is a pragmatic, prospective randomised controlled trial~   "
70548|NCT02133937|"~     This single-center, randomized open-label, single-dose, parallel group study will~     investigate the relative bioavailability of a high concentration liquid formulation (HCLF)~     versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will~     be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.~   "
70549|NCT02133924|"~     This research trial is designed to study the safety and effectiveness of combining the study~     drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new~     treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious~     complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft),~     treat the recipient's body as foreign and attack the cells in the recipient's body. During~     this immune system response, donor cells damage body tissues, such as the skin, liver,~     stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the~     transplant recipient. Acute GVHD usually happens within the first several months after~     transplant.~      The goal of this research is to develop a safer and more effective treatment for acute GVHD,~     and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the~     ultimate goal being safer and more effective transplant therapies for blood cancers such as~     leukemia, lymphoma, and multiple myeloma.~   "
70550|NCT02133911|"~     Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients~     with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave~     symptoms of angina in patients with stable coronary disease that is not suitable for~     surgical or percutaneous revascularization. It has been shown that in patients with stable~     coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear~     imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion~     in patients with dilated cardiomyopathy.~   "
70551|NCT02133898|"~     This is an open-label study assessing the efficacy of l-methylfolate as monotherapy in~     patients with mild to moderate major depressive disorder (MDD). The plan is to enroll 75~     patients with mild to moderate MDD based on the Structured Clinical Interview for DSM-IV~     (SCID) that have a Hamilton Depression Rating Scale-24 (HDRS-24) score between 8-24. The~     investigators will collect genotype data on methylenetetrahydrofolate Reductase (MTHFR), MTR~     and MTRR in this patient population. Subjects will be able to receive their genotype~     results, on request, upon completion of the study. The investigators hypothesize that~     depressed patients will be more likely to have a mutation in the MTHFR gene~   "
71147|NCT02126111|"~     The purpose of this study is evaluate the efficacy of a depigmented grass extract in the~     treatment of local allergic rhinitis.~   "
70552|NCT02133885|"~     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,~     diabetes, obesity and metabolic syndrome. Despite advances in life style modification and~     multi-drug therapies, 20-30% of all hypertensive patients remain resistant.~      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and~     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that~     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over~     activity of the sympathetic nervous system that initiates and sustains HTN. Thus, a~     mechanism-based breakthrough is imperative to develop novel strategies to prevent and~     perhaps eventually cure neurogenic hypertension (NH).~      This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis~     that minocycline treatment would produce antihypertensive effects in drug-resistant~     neurogenic hypertensive individuals.~   "
70553|NCT02133872|"~     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,~     diabetes, obesity and metabolic syndrome. Recent American Heart Association (AHA) statistics~     indicate that one-third of all adults in the United States of America suffer from HTN.~     Despite advances in life style modification and multi-drug therapies, 20-30% of all~     hypertensive patients remain resistant.~      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and~     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that~     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over~     activity of the sympathetic nervous system that initiates and sustains HTN. A surgical~     approach such as the recently developed Simplicity Catheter assisted renal denervation~     remains one of the few options available to these patients. Thus, a mechanism-based~     breakthrough is imperative to develop novel strategies to prevent and perhaps eventually~     cure neurogenic hypertension (NH). This study is designed to evaluate a low and high dose of~     minocycline to test the hypothesis that minocycline treatment would produce antihypertensive~     effects in drug-resistant neurogenic hypertensive individuals. Minocycline has been selected~     because of its demonstrated effects on inhibiting microglial activation and its ability to~     penetrate the blood brain barrier. There is no other compound available that is safer and~     displays specificity better than Minocycline in inhibiting microglial activation. Thus, the~     potential therapeutic benefits of this inexpensive, well tolerated, already FDA-approved~     drug that has minimal side effects would be enormous.~   "
70554|NCT02133859|"~     Sleep disordered breathing is very common in patients with chronic heart failure with~     reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat~     sleep apnea in these patients. This is an observational study to document changes in~     respiratory parameters in HF patients using ASV for a period of 12 months.~   "
70555|NCT02133846|"~     The purpose of this study is to determine the safety and tolerability [maximum tolerated~     dose (MTD) within planned dosing range] of intravenous (IV) infusions of TPI 287~     administered once every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with~     primary four repeat tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal~     degeneration, CBD) or progressive supranuclear palsy (PSP).~   "
70556|NCT02133833|"~     This is a prospective, self-controlled study to evaluate the efficacy of the Quantum~     spectrum radiation emitter for adhesive capsulitis.~   "
70557|NCT02133820|"~     To assess whether an opioid antagonist has any impact on the release of a strong painkiller~     in the blood when it is given to healthy volunteers when they have eaten and also when they~     have fasted.~   "
70558|NCT02133807|"~     To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy~     could affect atherosclerotic disease burden in coronary and carotid arteries of coronary~     heart disease patients with elevated Lp(a) levels.~   "
70559|NCT02133794|"~     The purpose of this project is to determine if using tomosynthesis, in conjunction with~     x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study~     will be to include the use of tomosynthesis with x-ray as usual practice when a patient~     comes to the emergency room with symptoms of a hip fracture.~   "
70560|NCT02133781|"~     This is an exploratory study using a strategy that has not been previously employed to~     investigate the effects of age and vaccine type on specific kinds of immune responses to~     licensed, 2009- 2010 influenza vaccine in children and adults.~   "
70561|NCT02133768|"~     To describe the need for re-catheterization and incidence of urological complications of~     routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track~     THA and TKA~   "
70562|NCT02133755|"~     The primary aim of this study is to determine the effect of dopamine agonist therapy on~     insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary~     syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on~     a constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical~     signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin~     resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is~     more significant in obese women with PCOS, even lean women can be insulin resistant. No~     current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested~     a dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and~     may have a pathogenetic role in the development of PCOS. No study to date has assessed the~     impact of dopamine agonist therapy on IR in patients with PCOS.~   "
70563|NCT02133742|"~     Despite substantial improvements of patients outcome in advanced RCC, durable and complete~     response is uncommon. The majority of patients eventually develop resistance and exhibit~     disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with~     axitinib may provide additional clinical benefit compared to axitinib alone.~   "
70564|NCT02133729|"~     Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This~     complication occurs in 4-10% and is associated with fetal complications and macrosomia. In~     addition, women with GDM have an increased risk to develop type 2 diabetes after delivery.~     Despite recommendations, it is difficult to follow-up all women with GDM during the~     postpartum period due to high numbers of subjects that exceed usual healthcare resources. It~     is therefore necessary to focus clinical attention toward women at high risk of type 2~     diabetes in order to set adequate preventive strategies.~   "
71148|NCT02126098|"~     The purpose of this study is to observe the clinical manifestation, Lab findings including~     chest CT scans, pathological findings and outcomes in chinese patients with pulminary~     vasculitis.~   "
70565|NCT02133716|"~     The aim of this study is to assess the non-inferiority of non- pharmacological breast milk~     expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.~      This is an experimental comparative study of non-inferiority randomized crossover, to be~     performed in Neonatal units of hospitals in the Community of Madrid.~      The 54 pair of preterm that after the selection criteria are included in the study, they~     performed the randomization of the sequence and breast milk expressed receive oral or 24%~     sucrose.~      The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age~     (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both~     groups will be accompanied by non-nutritive sucking and swaddling and administered two~     minutes prior to venipuncture.~      The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile~     (PIPP) and by percent of cry.~      Data for the primary objective was analysed per intention to treat. This study was approved~     by local ethical committee.~   "
70566|NCT02133703|"~     This non-therapeutic trial is for women who have received results of genetic testing for~     BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed~     decision making regarding risk management following testing to usual care. The researchers~     will test separate decision support tools for women who receive positive test results and~     women who receive negative/inconclusive test results. Among women who receive a positive~     test result, an interactive decision support intervention will be compared to a print~     intervention. Among women who receive an inconclusive result, an interactive intervention~     will be compared to usual care.~   "
70567|NCT02133690|"~     This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to~     determine the effectiveness of the rotavirus vaccine.~   "
70568|NCT02133677|"~     Brain metastasis (BM) is among the most feared complications in cancer because even small~     tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of~     patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ)~     is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to~     evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus~     concomitant TMZ in lung cancer and breast cancer patients with BM.~   "
70569|NCT02133664|"~     The primary aim is to collect data to determine the correct effect size on the primary~     outcome to aid in the design of a larger study: The primary outcome is to determine if~     lipoic acid and omega-3 fatty acids can improve cognitive function in people with multiple~     sclerosis that have cognitive dysfunction.~   "
70570|NCT02133651|"~     Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea.~     Treatment of this infection usually occurs using other antibiotics, but many individuals~     have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal~     Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after~     treatment for C. difficile. This study will involve taking biopsies from patients during~     their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora~     as compared to the stool flora. The investigators hope to discover the critical parts of a~     healthy microbiota.~   "
70571|NCT02133638|"~     The aim of this study is to distinguish possible differences in frequency of delirium after~     Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of~     undeliberate cerebral desaturation during non-cardiac surgery.~   "
70572|NCT02133625|"~     The proposed investigation is a Phase 1 trial to determine the safety, tolerability, and~     maximum tolerated dose (MTD) of the combination of pioglitazone ( and carboplatin patients~     with advanced or metastatic solid malignancies.~   "
70573|NCT02133612|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients~          with regional lymph node metastases have worse outcome than those without lymph node~          metastases.~        -  No standard postoperative adjuvant chemotherapy has ever been established.~   "
70574|NCT02133599|"~     Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed~     with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For~     the purposes of this protocol, ALL will be used to refer to patients with either acute~     lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same~     manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard~     treatment for most ALL patients. However, high plasma and intracellular MTX concentrations~     (defined as a MTX level of >1 µmol/L at 42 hours and > 0.40 µmol/L at 48 hours) can quickly~     lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal~     toxicities requiring extended hospitalization and delays in subsequent chemotherapy~     treatments.~      This study seeks to identify more sensitive markers of kidney injury that could serve as~     better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot~     repeated-measures feasibility study.~      Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of~     kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity~     and specificity for prediction of delayed MTX excretion and/or toxicity in children and~     adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If~     this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity,~     then another study will be developed in the future to determine if modifying the HDMTX dose~     or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity~     without impacting patient survival.~      Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or~     toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following~     initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers~     will increase prior to a measurable sCr elevation.~   "
70575|NCT02133586|"~     The U.S. Environmental Protection Agency has traditionally examined the effects of single~     pollutant exposure on human health outcomes; however, to provide a better assessment of~     pollutant exposure-associated effect on human health the Agency is moving toward a~     multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air~     quality standards (NAAQS) criteria pollutants that are major constituents of ambient air~     pollution. This study will address the Agency's goals by investigating the cardiopulmonary~     health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The~     findings of this study will provide data that will inform risk assessment models for O3 and~     NO2 exposures. Additionally, the findings will provide insight into how the human health~     effects of multi-pollutant exposures differ from those of single pollutant exposures.~   "
70602|NCT02133235|"~     The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial~     blockers (EBB) have been presented effective and safe alternative for lung separation in~     vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will~     randomize the patients receiving VATS operation with EBB into two groups: one group will~     receive the conventional bronchoscopic guided EBBs placement, the other group receive two~     step procedure without confirmation by fiberoptic bronchoscopy.~   "
70576|NCT02133573|"~     Neurodevelopmental disability is now recognized as the most common long-term complication~     after cardiac surgery in neonates. Research studies have shown that progesterone is critical~     to the development of the brain and in a variety of clinical situations including brain~     injury can protect the brain.~      The purpose of this research study is to determine whether progesterone administered during~     the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn~     babies with CHD and improves their neurodevelopmental outcomes after heart surgery.~   "
70577|NCT02133560|"~     Purpose: Assess whether intensive training with education and daily remote monitoring with~     provider involvement has a lasting positive impact on adherence to medication management.~     The study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less~     than 100% compliance for taking iron chelators in the previous three month prior to~     participation in the study. Subjects will be asked to monitor their daily iron chelator~     administration by taking a video recording of preparing it and ingesting at least one sip.~     Subjects will also use a medication log to record daily administration of medication, and~     meet with study staff monthly for educational activities. The data collected will be~     analyzed to describe patient adherence and comfort level with the process of daily recording~     of medication management. Mean percent adherence in the pre-study periods and each of the~     study periods will be analyzed and compared.~   "
70578|NCT02133547|"~     Primary ciliary dyskinesia (PCD) is a rare genetic disorder characterized by impaired airway~     mucociliary clearance leading to recurrent respiratory infections, bronchiectasis and~     eventually respiratory insufficiency. Diagnosis of PCD is difficult and relies on complex~     methods which are not widely available (1).~      Nasal nitric oxide (nNO) is reduced in PCD patients as compared to normal subjects, and nNO~     measurement has been proposed as a non-invasive screening tool for PCD. However, nNO~     measurement techniques are not standardized and reference values are lacking (2, 3).~      The NIOX MINO is a handheld analyzer developed for the non-invasive measurement of exhaled~     NO (eNO) in asthmatics. Measurement of nNO with the NIOX MINO has been reported in only few~     studies (4-6), which mainly compared the NIOX MINO with others NO analyzers. However, no~     study attempted to establish reference values with the NIOX MINO in a large number of normal~     subjects.~      One critical issue in nNO measurement is to avoid contamination of nasal air by exhaled~     alveolar air during nNO sampling. This can be obtained by either breath holding, or by a~     breathing technique allowing soft palate closure during sampling, such as mouth breathing~     again resistance. However, as sampling times with the NIOX MINO are long (2 minutes at a~     flow of 2 ml/min, and 45 seconds at a flow of 5 ml/min), these techniques may be difficult~     to apply.~      In this pilot study, we will determine normal nNO values in 100 healthy men and women aged~     20 to 70 years using 3 different breathing techniques:~        1. breath holding during 45 seconds~        2. mouth breathing through a fixed resistance (a straw), to create a small positive~          pressure in the oropharynx during expiration only~        3. mouth breathing through a continuous positive airway pressure (CPAP) apparatus, which~          produces continuous soft palate closure during quiet spontaneous breathing, thus~          allowing long sampling times for nNO measurement.~      This study will allow: 1) to determine whether nNO can be reliably measured with the NIOX~     MINO in adult normal subjects, 2) to identify the most reproducible breathing technique, 3)~     to determine normal values of nNO as measured by the NIOX MINO, and 4) to explore possible~     differences between genders and age groups.~      References:~        1. J.S.A. Lucas, W.T. Walker, C.E. Kuehni and R. Lazor. Primary ciliary dyskinesia. Eur~          Respir Mon. 2011; 54: 201-217.~        2. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline~          Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am~          J Respir Crit Care Med 2005; 171: 912‑30.~        3. Marthin JK, Nielsen KG. Choice of nasal nitric oxide technique as first-line test for~          primary ciliary dyskinesia. Eur Respir J 2011; 37: 559‑65.~        4. Marthin JK, Nielsen KG. Hand-Held Tidal Breathing Nasal Nitric Oxide Measurement - A~          Promising Targeted Case-Finding Tool for the Diagnosis of Primary Ciliary Dyskinesia.~          PLoS ONE 2013; 8: e57262.~        5. Weschta M, Deutschle T, Riechelmann H. Nasal fractional exhaled nitric oxide analysis~          with a novel hand-held device. Rhinology 2008; 46: 23‑7.~        6. Maniscalco M, Laurentiis G de, Weitzberg E, Lundberg JO, Sofia M. Validation study of~          nasal nitric oxide measurements using a hand-held electrochemical analyser. Eur J Clin~          Invest 2008; 38: 197‑200.~   "
70579|NCT02133534|"~     The purpose of this study is to see if patients with chronic kidney disease have endothelial~     cells that don't function properly, which is thought to be a marker for cardiovascular risk.~     Endothelial cells line the heart and blood vessels. The investigators will treat your high~     cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine~     if this cholesterol lowering drug improves subjects' cholesterol as well as the function of~     endothelial cells.~   "
70580|NCT02133521|"~     This is a prospective, randomized, double-blind, and controlled clinical study to~     investigate the effects of DLBS1033 in conjunction with standard therapy compared to~     standard therapy alone in acute ischemic stroke patients. It is hypothesized that the~     improvement in functional outcomes as measured by NIHSS and BI as well as the improvement in~     haemostatic parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and~     d-dimer in DLBS group will be significantly greater than those in the control group.~   "
70581|NCT02133508|"~     This multicenter, retrospective and prospective observational, cohort study will examine the~     effect of second-line Tarceva treatment on long response in NSCLC patients with wild type or~     unknown EGFR status. Patients will be observed from the start of treatment for 8 months or~     until death. The extension of the retrospective versus prospective observation will depend~     on the lag between the date of the patient enrollment and the date of beginning of erlotinib~     therapy.~   "
70582|NCT02133495|"~     The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived,~     non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the~     correction of lower eyelid retraction, taking into consideration issues associated with the~     use of acelular dermis such as contraction and potential regression of repairs.~   "
70583|NCT02133482|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     639667 in healthy male subjects following oral administration of single rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667~     after single dosing and the assessment of the PK/PD relationship.~   "
70584|NCT02133469|"~     A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7~     and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the~     prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C,~     19F, and 23F combined) in 2 to 5 years old healthy Chinese children.~   "
70585|NCT02133456|"~     To monitor the safety of Shanghai Institute of Biological Products Company's influenza~     vaccine in subjects aged 3 years and older through Adverse Events Following Immunization~     Surveillance System of China.~      The hypothesis is that there is no significant difference in the occurrence of adverse~     events among influenza vaccines manufactured by SIBP and other companies.~   "
70586|NCT02133443|"~     Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains~     challenging, and several methods have been suggested. However none of them seems easily~     utilisable. Thus the investigators propose to test a way of NAVA level titration according~     to ventilator comfort.~   "
70587|NCT02133430|"~     The purpose of this study is to compare the difference of incidence of postoperative~     delirium between patients received general anesthesia guided by Bispectral index (BIS) and~     patients received general anesthesia using standard technique.~   "
70588|NCT02133417|"~     Conduct a case collection study of breast imaging examinations from women with~     mammographically-detected breast lesions for the purpose of conducting subsequent Reader~     Studies.~   "
70589|NCT02133404|"~     To examine efficacy and safety after 12-week administration of ASP7991 in secondary~     hyperparathyroidism patients undergoing hemodialysis~   "
70590|NCT02133391|"~     This study focuses on implementing and evaluating an evidence-based collaborative method of~     increasing immunization rates among preschool children, adolescents and adults within an~     Accountable Care Organization-Public Health collaborative. The infrastructure we will create~     through this project will serve as the framework for future collaborative delivery of other~     preventive services.~   "
70617|NCT02133040|"~     The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in~     humans in an observational study on patients with thyrotoxicosis. In the investigators~     evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in~     the acute phase of the disease and in the euthyroid phase after treatment.~      It is the investigators hypothesis that high levels of circulating T3 might affect amount~     and function of brown adipose tissue.~   "
70629|NCT02132884|"~     This randomized clinical trial studies how well genetic sequencing-informed targeted therapy~     works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy~     is a type of treatment that uses drugs or other substances to identify and attack specific~     types of tumor cells that may have less harm to normal cells. Genetic sequencing may help~     identify these specific types of tumor cells in patients with non-small cell lung cancer.~   "
70591|NCT02133378|"~     A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix,~     coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to~     be extremely effective, in addition to traditional means, in terminating bleeding during~     cardiac operations with control rates as high as 97,5%. The investigators compared such~     hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized~     hemostasis routine.~      Following sample size calculation, in a prospective randomized study design, 100 patients~     will be treated with Hemopatch and 100 patients will receive traditional optimized~     hemostasis routine (comparison group).~      To make the two cohorts as comparable as possible enrollment will be restricted to~     moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately~     bleeding transversal aortotomy.~      Study endpoints are the following: rate of successful intraoperative hemostasis (identified~     by cessation of bleeding in less than 3 minutes from application) and time required for~     hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of~     surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.~   "
70592|NCT02133365|"~     This is an investigation of a mindfulness and interoceptive exposure intervention in~     patients with atrial fibrillation, to decrease anxiety sensitivity, symptom burden, and~     atrial fibrillation recurrence.~   "
70593|NCT02133352|"~     This is a single center, open-label trial designed to assess the safety and efficacy of~     ranolazine (Ranexa) in patients with pulmonary hypertension associated with left ventricular~     diastolic dysfunction. All patients will receive active drug. The study includes a screening~     period, 6 month treatment period and a follow up period. Eligible patients who provide~     informed consent and who meet all inclusion/exclusion criteria will be enrolled in this~     study.~      There is neither proven therapy for patients with diastolic dysfunction-associated pulmonary~     hypertension nor for patients with diastolic dysfunction alone. Ranolazine, an inhibitor of~     cardiac repolarization (sodium channels), could represent a new and effective treatment of~     this entity.~   "
70594|NCT02133339|"~     This single ascending dose study is to determine and evaluate the safety and tolerability of~     TRN-157 in approximately 40 healthy subjects.~   "
70595|NCT02133326|"~     This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when~     compared to single dose of IV acetaminophen in reducing pain. We will administer this study~     medication thirty minutes prior to removal of wisdom teeth. We want to see if administering~     these drugs prior to surgery may reduce post-operative pain.~      Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation~     during surgery will reduce postoperative pain following third molar extraction when compared~     to the acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will~     consume less opioid medications compared to those receiving preemptive acetaminophen.~   "
70596|NCT02133313|"~     The time on peritoneal dialysis may be limited for a significant number of patients that use~     this modality of renal replacement therapy due to the inability of the peritoneal membrane~     to clear solutes or achieve adequate ultrafiltration, termed peritoneal membrane failure~     (PMF). This can be devastating for patients who have become accustomed to the quality of~     life provided by peritoneal dialysis and who otherwise have done well on this therapy. There~     is clinical evidence suggesting that icodextrin preserves the peritoneal membrane transport~     characteristics which may be linked to reduced cumulative glucose exposure of the peritoneal~     mesothelial cells. Theories to explain the role of dextrose in PMF have focused for the most~     part on the high intracellular concentrations of glucose without consideration to the~     potential pathogenic role of the glucose transporters which allow glucose entry into the~     cell. Experimental evidence in non-mesothelial cell lines indicate that some cellular~     processes that occur under high glucose conditions may not be related to intracellular~     glucose metabolism but to the type of glucose transporter allowing glucose entry. 3,4~     However, little is known about these glucose transporters in peritoneal mesothelial cells~     and their potential role in the development of PMF.~      We hypothesize the following~        -  The presence of Sodium Glucose Co-transporter (SGLT1) on peritoneal mesothelial cells~          plays a role in PMF under hyperglycemic conditions.~        -  Regulation of pro-fibrotic mediators such as reactive oxidative species,transforming~          growth factor β, and vascular endothelial growth factor are modulated by SGLT1~          activation by glucose rather than glucose metabolism or concentration.~        -  Icodextrin does not activate the SGLT1 transporter establishing a mechanism that may~          explain the beneficial effects of icodextrin on peritoneal membrane transport.~   "
70597|NCT02133300|"~     Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular~     electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant~     side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients~     will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and~     non-stimulated side will be compared for it's thickness (by using ultrasound imaging),~     muscle strength if the patients are awake and cooperative (using the medical research~     council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary~     outcome the investigators hypothesize that electrical stimulation will preserve muscle mass~     with respect to the non-stimulated quadriceps. As secondary outcomes the investigators~     hypothesize that electrical stimulation can reduce muscle strength loss and leads to a~     better protein balance and thicker muscle fibers in the stimulated quadriceps.~   "
70598|NCT02133287|"~     To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating~     Coronary Revascularization.~   "
70599|NCT02133274|"~     The purpose of this study is to determine whether a brief psychosocial intervention together~     with early palliative care are feasible, acceptable and effective in the reduction of~     depressive symptoms of patients with advanced cancers starting first line palliative~     chemotherapy.~   "
70600|NCT02133261|"~     The purpose of this research study is to learn if a new 7 day patch ECG recording monitor~     can serve the same purpose as standard monitoring systems. The new 7day patch is~     significantly smaller and lighter than previous ECG recorders.~   "
70601|NCT02133248|"~     Many people who are on the wait list for a kidney transplant have harmful antibodies, called~     donor specific antibodies (DSA), which will attack foreign tissue such as the transplanted~     organ. These people are considered to besensitized. Prior to receiving a kidney, these~     patients undergo desensitization treatments to remove these harmful antibodies. Levels of~     DSA are measured after desensitization, but the cells that produce the DSA, donor specific B~     cells (DSB), have not generally been measured. Additionally, if a person experiences chronic~     rejection due to antibodies they are also desensitized, but only the DSA are measured. This~     study will measure the DSA and, using new techniques, the DSB in two study groups: those who~     are receiving an organ and those experiencing chronic antibody mediated rejection after~     receiving an organ. The hypothesis is people with higher levels of DSB after desensitization~     are more likely to develop antibody mediated rejection.~   "
84356|NCT01953237|"~     We propose to develop and pilot test the effect of a mobile smartphone intervention,~     MedActive, on improving antipsychotic adherence among individuals with schizophrenia.~   "
70603|NCT02133222|"~     Therapies that target specific molecules markedly inhibit cancer growth in several~     malignancies, and provide valuable strategies for the treatment of advanced melanoma. In~     recent years, BRAF and KIT have become established therapeutic targets in melanoma patients~     showing activating mutations in these oncogenes. However, it is crucial that genetic~     mutations present in the melanoma lesions are identified if the investigators are to design~     tailormade therapies for individual patients. The tumour genotypes that determine the~     selection of molecular-targeted therapies are usually identified in primary tumours;~     however, primary tumours are not always representative of metastases. Circulating free DNA~     may be a source of valuable information because it can be obtained via routine blood~     sampling, it provides real-time information about a patient's current disease state, and it~     allows monitoring and molecular characterization before and after chemotherapy. The aim of~     the study is to determine the mutational status in circulating DNA in melanoma metastatic~     patients, with the Sequenom Mass Array, a next generation sequencing technology. Results~     obtained before and after treatment will be compared with the primary tumor genotype.~   "
70604|NCT02133209|"~     112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress~     Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including~     headache frequency and impact and brain activity, will be assessed at baseline, prior to~     intervention, and at 3-, 6-, and 12-months.~   "
70605|NCT02133196|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy that involves taking white~     blood cells from patients' tumors, growing them in the laboratory in large numbers, and then~     giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes,~     or TIL and we have given this type of treatment to over 100 patients. In this study, we are~     selecting a specific subset of white blood cells from the tumor that we think are the most~     effective in fighting tumors and will use only these cells in making the tumor fighting~     cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is~     safe.~      Eligibility:~      - Adults age 18-70 with NSCLC who have a tumor that can be safely removed.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
70606|NCT02133183|"~     This partially randomized pilot trial studies how much sapanisertib reaches the brain tumor~     and how well it works when given before and after surgery in treating patients with~     glioblastoma that has grown or come back and requires surgery. Sapanisertib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
70607|NCT02133170|"~     This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator)~     controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder~     (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms~     are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment~     plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus~     structured group psychoeducation; 3) treatment as usual (TAU), including standard~     psychiatric care with standard pharmacologic treatment.~   "
70608|NCT02133157|"~     Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular~     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity~     has demonstrated potent inhibitory effects on multiple human tumor xenografts. This~     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended~     dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor~     activity of HMPL-012 at single doses and multiple doses .~   "
70609|NCT02133144|"~     A. BACKGROUND Accumulation of fat in the liver due to non-alcoholic causes (NAFLD) is~     associated with hepatic insulin resistance, which impairs the ability of insulin to inhibit~     the production of glucose and VLDL . This leads to increases in serum glucose, insulin and~     triglyceride concentrations as well as hyperinsulinemia. Recent epidemiologic studies have~     shown that a major reason for the metabolic syndrome as well as the accompanying increased~     risk of cardiovascular disease and type 2 diabetes is overconsumption of simple sugars. The~     investigators have recently shown that overeating simple sugars (1000 extra calories/day,~     CANDY diet) increases liver fat content by 30% within 3 weeks (4), and recapitulates~     features of the metabolic syndrome such as hypertriglyceridemia and a low HDL cholesterol~     concentration.~      The fatty acids in intrahepatocellular triglycerides may originate from peripheral~     lipolysis, de novo lipogenesis, uptake of chylomicron remnants by the liver and from hepatic~     uptake of fatty acids released during intravascular hydrolysis of triglyceride-rich~     lipoproteins (the spillover pathway). A classic study using stable isotope methodology by~     the group of Elisabeth Parks showed that in subjects with NAFLD, the excess~     intrahepatocellular triglycerides originate from peripheral lipolysis and de novo~     lipogenesis.~      It is well-established that ingestion of a high carbohydrate as compared to high fat diet~     stimulates de novo lipogenesis in humans. Meta-analyses comparing isocaloric high fat and~     high carbohydrate diets have shown that high carbohydrate but not high fat diets increase~     increase serum triglycerides and lower HDL cholesterol. Since hypertriglyceridemia results~     from overproduction of VLDL from the liver, these data suggest the composition of the diet~     influences hepatic lipid metabolism. Whether this is because overfeeding fat leads to~     preferential deposition of fat in adipose tissue while high carbohydrate diets induce a~     relative greater increase in liver fat is unknown. There are no previous studies comparing~     effects of chronic overfeeding of fat as compared to carbohydrate on liver fat or and the~     sources of intrahepatic fatty acids.~      A common polymorphism in PNPLA3 at rs738409 (adiponutrin) gene is associated with a markedly~     increase liver fat content. This finding has been replicated in at least 20 studies across~     the world. The investigators have shown that PNPLA3 is regulated by the carbohydrate~     response element binding protein 1. Mice overexpressing the human I148M PNPLA3 variant in~     the liver exhibit an increase in liver triglycerides and cholesteryl esters on a high~     sucrose but not high fat diet. These data suggest that overfeeding a high carbohydrate as~     compared to a high fat diet may increase liver fat more in subjects carrying the I148M~     allele than in non-carriers.~      B. HYPOTHESIS The investigators hypothesize that overfeeding a high fat as compared to an~     isocaloric high carbohydrate diet influences the source of intrahepatocellular~     triglycerides. During a high fat diet, relatively more of intrahepatocellular triglycerides~     originate from peripheral lipolysis and less from DNL than during a high carbohydrate diet~     in the face of a similar increase in liver fat. It is also possible given the lack of~     previous overfeeding data comparing 2 different overfeeding diets that the high fat diet~     induces a smaller increase in liver fat than a high carbohydrate diet even in the face of an~     identical increase in caloric intake because a greater fraction of ingested fat is channeled~     to adipose tissue than the liver. The investigators also hypothesize that liver fat may~     increase more in carriers than non-carriers of the I148M variant in PNPLA3 during a high~     carbohydrate than a high fat diet.~      C. SPECIFIC AIMS The investigators wish to randomize, using the method of minimization~     (considers baseline age, BMI, gender, liver fat, PNPLA3 genotype) 40 non-diabetic subjects~     with NAFLD as determined by the non-invasive score developed in our laboratory or previous~     knowledge of liver fat content based on MRS to overeat either a high carbohydrate or high~     fat diet (1000 extra calories per day) for 3 weeks. Before and after the overfeeding diets,~     will measure liver fat content by 1H-MRS and the rate of adipose tissue lipolysis using~     doubly labeled water (DDW) and [1,1,2,3,3-2H5] glycerol as described in detail below. The~     investigators also wish to characterize glucose, insulin, fatty acid and triacylglyceride~     profiles before and while on the experimental diet. An adipose tissue biopsy is taken to~     determine whether expression of genes involved in lipogenesis or lipolysis, or those~     involved in adipose tissue inflammation change in response to overfeeding, and for~     measurement of LPL activity. After overfeeding, both groups will undergo weight loss to~     restore normal weight as described in our recent study. The metabolic study is repeated~     after weight loss.~   "
70610|NCT02133131|"~     This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in~     treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The~     objective is to determine the proportion of participants achieving sustained virologic~     response 12 weeks after ending study treatment (SVR12).~   "
70611|NCT02133118|"~     Next to HbA1c, body weight is regarded as an important surrogate end-point in trials~     investigating glucose-lowering agents. An increase in weight could contribute to worsening~     insulin resistance. Differences in weight after starting glucose lowering agents have been~     described in many randomized controlled trials (RCTs).~      With this prospective observational study, weight trajectories after receiving add-on~     therapy next to metformin are evaluated in primary care patients with good glycaemic~     control.~   "
70612|NCT02133105|"~     Although inotropes have a favorable effect on central hemodynamics in patients with heart~     failure, their effect on renal hemodynamics is incompletely defined. The purpose of this~     study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared~     to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with~     chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is~     that patients treated with levosimendan will show greater increases in renal blood flow and~     glomerular filtration rate (GFR) than those treated with dobutamine.~   "
70613|NCT02133092|"~     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in~     pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower~     respiratory tract infection (LRTI).~   "
70614|NCT02133079|"~     To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and~     Pancreatic Adenocarcinoma~   "
70615|NCT02133066|"~     The reported rate of unsuccessful spinal taps in children, especially young infants, is~     high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal~     taps.~   "
70616|NCT02133053|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition~     the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient~     applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the~     instructions for use. The observation takes place over a period of 14 days. Response to~     treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a~     dairy.~   "
70618|NCT02133027|"~     Objective:To explore the role of the right portal pedicle and Rouviere's sulcus as an~     anatomic landmark in laparoscopic cholecystectomy.~      Methods:The investigators are going to select 60 patients intending to perform Laparoscopic~     cholecystectomy from April 2014 to April 2015.Check out the presence of the right portal~     pedicle and Rouviere's sulcus during the surgery and divide into the experimental group and~     the control group.Experimental group operated in Laparoscopic cholecystectomy with the guide~     of Rouviere's sulcus while the Control group operated with the traditional way.~      Research hypothesis:Compare the differences between the Experimental group and the Control~     group in bile duct injury rate,complication rate,blood loss,operative time ,conversion rate~     and hospital stay.It is supposed that the results of Experimental group are superior to the~     control group,difference is statistically significant(P<0.05). So the investigators can draw~     the conclusion that the anatomy method with the guide of right portal pedicle and Rouviere's~     sulcus is useful in laparoscopic cholecystectomy.~   "
70619|NCT02133014|"~     The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous~     catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases~     SAP patients from April 2014 to April 2015 who carry on the treatment in our hospital,and~     divide into the experimental group and control group under respect the wishes of patient in~     the case.The experimental group use the method of laparoscopic-assisted percutaneous~     drainage to carry on the treatment,the control group patients use conventional conservative~     therapy to carry on the treatment.Contrastive analyze two groups of patients clinical care~     effects.~      Research hypothesis:according to compare the mortality,the incidence of complications~     ,hospital stay and other research indicators of two groups .It is supposed that the research~     indicators of experimental group are lower than the control group ,difference was~     statistically significant(P<0.05).We can draw the conclusion that the method of~     laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to~     be promoted on clinical.~   "
70620|NCT02133001|"~     The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram~     (mg) compared with intranasal placebo along with standard care treatment, in reducing the~     symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a~     dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is~     prominent and relatively persistent), including the risk for suicide as assessed by the~     Investigator, in participants who will be assessed to be at imminent risk for suicide.~   "
70621|NCT02132988|"~     The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving~     Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian,~     fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based~     chemotherapy as initial treatment for primary disease or as salvage treatment for first~     relapse.~   "
70622|NCT02132975|"~     Study, for the first time in clinical conditions, the potential contribution, in terms of~     accuracy, of the motorised probe holder during prostate biopsies.~   "
70623|NCT02132962|"~     The study investigates the effect of aminoacid infusion on proteinturnover in muscle from~     cirrhosis subjects, compared to healthy controls.~      The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation~     that follows cirrhosis.~   "
70624|NCT02132949|"~     This multicenter, non-randomized, open-label, phase II study is designed to evaluate the~     safety and efficacy of Perjeta in combination with Herceptin and anthracycline-based~     chemotherapy as neoadjuvant treatment in patients with HER2-based locally advanced,~     inflammatory, or early-stage breast cancer. Each investigator will choose a treatment~     regimen (A or B) for all their patients to follow. Treatment A (Cohort A): Patients will~     first be given doxorubicin (60 mg/m2 IV) and cyclophosphamide (600 mg/m2 IV). This will be~     followed by administration of paclitaxel (80 mg/m2 IV), Perjeta (420 mg IV) and Herceptin (6~     mg IV) for four cycles. Treatment B (Cohort B): Patients will first receive 5-fluorouracil~     (500 mg/m2 IV), epirubicin (100 mg/m2 IV), and cyclophosphamide (600 mg/m2 IV). This is to~     be followed by docetaxel (100 mg/m2 IV), Perjeta (420 mg IV) and Herceptin (6 mg IV)~     treatment for four cycles. Patients in both cohorts will subsequently undergo surgical~     treatment and then resume Perjeta and Herceptin treatment. Total time on treatment is~     expected to last 1 year; patients will be followed-up for a further 4 years.~   "
70625|NCT02132936|"~     The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of~     calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis~     vulgaris~   "
70626|NCT02132923|"~     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of~     Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed~     lower respiratory tract infection (LRTI).~   "
70627|NCT02132910|"~     The purpose of the study is to learn about the effect of integrative therapies on chronic or~     recurrent low back pain.~      The intervention called RESTORE (Restorative Exercises for Strength Training and Operational~     Resilience) is based on a series of gentle stretching and strengthening exercises~     incorporating breath-work and mindfulness. The study is designed to discover the impact of~     RESTORE on pain levels, physical function, and behavioral health.~   "
70628|NCT02132897|"~     Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer~     drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with~     time due to metabolism autoinduction.~      The primary objective of this study is to estimate the bioequivalence of the new brand~     generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product~     (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary~     objective will be evaluation of safety issues.~      The study design will be randomized two sequences, two periods and crossover. For a power of~     not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be~     administered with food (high calories/high fat breakfast) after an overnight fast.~      Time vs. concentration curves will be built for each subject and formulation and Area Under~     Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to~     infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual~     curves.~      This parameters will be statistically processed with the WinNonlin 6.3~     Pharmacokinetics/Statistic software in order to prove bioequivalence between the study~     products.~   "
84357|NCT01953224|"~     The purpose of the study is to test an intervention that uses a mobile game to encourage~     increased physical activity among adults.~   "
70631|NCT02132858|"~     This research trial studies genetic mutations in blood and tissue samples to see if they can~     be used to predict treatment response in patients with locally advanced rectal cancer~     undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from~     patients with cancer may help doctors learn more about genetic mutations or changes that~     occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to~     treatment.~   "
70632|NCT02132845|"~     This randomized clinical trial studies how well next generation sequence target-directed~     therapy works in treating patients with cancer. Next generation sequencing is a test that~     screens for mutations to cancer related genes. Target-directed therapy is a type of~     treatment that uses drugs or other substances to identify and attack specific types of~     cancer cells that may have less harm to normal cells. Next generation sequencing may help~     identify these specific types of cancer cells.~   "
70633|NCT02132832|"~     This project has two primary goals. The first goal is to further scientific understanding~     about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1)~     stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e.g., attentional~     bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias~     to marijuana stimuli via administration of buspirone.~      Buspirone is uniquely suited to this project because it has effects on neurotransmitter~     systems known to modulate both stress/anxiety and attentional bias.~   "
70634|NCT02132819|"~     Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are~     afraid of facing during the follow up of newborns. During the last years, investigators ran~     retrospective observational studies abut NEC developing within the 48 hours after red blood~     cell transfusion. In the previous studies, the incidence of transfusion associated NEC~     (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for~     retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis~     about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion,~     similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the~     neonatology clinics, withholding feeds during transfusion is not preferred. But several~     recent studies show an increase in the incidence of TANEC if the newborn goes on feeding~     before, during and after the transfusion process, especially if it is fed with a formula.~     The main aim of this study is to investigate the effect of withholding feeds during~     transfusion, on the development of TRAGI.~   "
70635|NCT02132806|"~     The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment~     of class II furcation involvement using biomaterials and new surgical techniques~   "
70636|NCT02132793|"~     The immediate objective of this project was to demonstrate the feasibility of Remote~     Exercises for Learning Anger and Excitation Management (RELAX). The application is a remote,~     technology- enabled, anger treatment and management system based on current evidence-based~     CBT interventions. The project's objective was to show that RELAX (1) enables the practice~     of anger management strategies remotely through mobile phone interfaces; (2) integrates with~     evidence-based treatments through the implementation of an existing CBT anger management~     course; (3) provides information, direction, and feedback through physiological sensors and~     signal analysis; and (4) supports communication and direction by the therapist through a~     web-based therapist interface.~   "
70637|NCT02132780|"~     There is a significant association between autonomic dysfunction and symptoms experienced by~     NAFLD patients mediated by increased systemic inflammation and insulin resistance, resulting~     in deteriorating quality of life of affected patients; fatigue and other symptoms drive~     worsening autonomic dysfunction in these patients. We aim to describe the severity of~     autonomic dysfunction (AD) in non-alcoholic fatty liver disease (NAFLD) and the relationship~     of AD to symptoms experienced by NAFLD patients (such as fatigue, chronic pain, depression,~     sleep disturbance, and cognitive dysfunction), and to the quality of life of NAFLD patients.~     We also hope to examine the impact of systemic inflammation and insulin resistance as~     mediators of manifestations of AD and symptoms experienced by NAFLD patients.~   "
70638|NCT02132767|"~     The purpose of this study is to compare the therapeutic strategies of rate control versus~     rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial~     fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after~     cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in~     hospital within 60 days of the occurrence of AF compared to a strategy of rate control.~   "
70639|NCT02132754|"~     This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum~     administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A,~     MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may~     progress to Part B, in which the preliminary MTD will be identified. Based on safety events~     the study may progress to Part C in which the MTD will be confirmed. In Part D, participants~     will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg~     to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events~     in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with~     pembrolizumab will be confirmed.~      The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination~     with pembrolizumab have acceptable safety and tolerability.~   "
70640|NCT02132741|"~     Patients with high blood pressure (hypertension) and chronic kidney disease are at an~     increased risk of developing heart disease and strokes. Part of this risk is due to changes~     in the structure and function of the blood vessels throughout the body. It is thought that~     reducing high blood pressure and treating chronic kidney disease improves the structure and~     function of blood vessels but information on this is limited. Optical coherence tomography~     (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple,~     quick and non-invasive test that you may have previously had during a visit to the optician.~     The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's~     blood vessels in patients with hypertension and chronic kidney disease compared to healthy~     individuals and also to see if any differences seen improve with treatment.~   "
70641|NCT02132728|"~     This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and~     inflammatory indicators in male workers of a food industry.~   "
70642|NCT02132715|"~     As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults~     rises, the prevention of OA-associated disability is an important public health priority.~     Accordingly, efficacious interventions are needed to manage pain and maintain physical~     function among older adults with OA. Because skeletal muscle weakness is a primary~     contributory factor to the progression of pain and functional decline among persons with OA,~     optimal interventions are those capable of improving skeletal muscle strength.~     High-intensity resistance exercise is the best-known method of improving muscle strength;~     however high-compressive loads typically induce significant joint pain among persons with~     OA. Accordingly, current recommendations include the performance of low- or~     moderate-intensity physical exercise - despite the fact that these training paradigms are~     sub-optimal for enhancing muscle strength. This application proposes conduct a pilot study~     to investigate the potential of an innovative training paradigm with potential to stimulate~     improvements in skeletal muscle strength while utilizing low-intensity loads. This paradigm,~     known as KAATSU training, involves performing low-intensity exercise while~     externally-applied compression mildly restricts blood flow to the active skeletal muscle.~     The overarching objective of the present application is to evaluate the efficacy and~     feasibility of chronic KAATSU training for the improvement of skeletal muscle strength and~     physical function among persons aged > 60 years with symptomatic knee OA and mild to~     moderate physical limitations. Up to 72 participants will be recruited to participate in~     this three month intervention study. Participants will be randomly assigned to one of two~     intervention conditions: (1) a standard exercise intervention consisting of center-based,~     moderate-intensity resistance training, or (2) a KAATSU training program matched for overall~     workload. This study will provide novel information regarding the therapeutic potential of~     KAATSU training for improving strength and function as well as attenuating pain among these~     individuals. The study will also provide critical information regarding the long-term,~     clinical viability of the paradigm by evaluating participant safety, discomfort, and~     willingness to continually engage in the KAATSU training program.~   "
70643|NCT02132702|"~     This study is to evaluate the performance attributes and user progression of participants~     with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic~     exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement~     in progression and overall health while using Ekso.~   "
70644|NCT02132689|"~     Currently there is no clear guidance for the treatment of moderate risk of pulmonary~     embolism. The aim of the study is to compare two different therapeutic modalities - standard~     anticoagulation versus thrombolytic treatment followed by anticoagulation in standard~     regimen as stated in the pulmonary embolism guidelines.~   "
70645|NCT02132676|"~     The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P)~     in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment~     of diabetes in five VA health systems, and to study the implementation process in order to~     gather information required to disseminate the program more broadly in the VHA system.~   "
70646|NCT02132663|"~     This clinical trial will evaluate an investigational infant formula with an alternate source~     of DHA to determine if it provides normal growth and if it is well tolerated by term infants~     as compared to a marketed routine infant formula.~   "
70647|NCT02132650|"~     The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of~     older Veterans grows, stroke will become an increasingly important problem to the VHA.~     Recovery of walking function is the most common goal of stroke survivors. The proposed study~     will test whether training with accurate walking tasks to engage the damaged supraspinal~     motor pathways is more effective than training with steady state walking. The investigators~     expect that training accurate tasks will be more effective, thereby improving walking~     function of Veteran stroke survivors and reducing the burden of care placed on families and~     on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost~     to existing rehabilitation approaches, which is important given that the VHA invests $88~     million per year toward outpatient care, including physical rehabilitation, in the first six~     months after stroke. This research also has implications for rehabilitation of other~     neurologically injured populations, including traumatic brain injury and incomplete spinal~     cord injury.~   "
70648|NCT02132637|"~     The primary purpose of this study is to compare the effect of double doses of a study drug~     known as insulin peglispro and insulin glargine in participants who have type 2 diabetes.~     Participants will be treated for up to 11 weeks, and will take part in two study periods.~     Each participant will receive insulin peglispro during one treatment period and insulin~     glargine during the other treatment period.~   "
70649|NCT02132624|"~     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and~     efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting~     antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and~     4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus~     vector. Prior to T cell infusion, the patients will be subjected to preconditioning~     treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse~     reactions, persistence of CAR T cells and efficacy.~   "
70650|NCT02132611|"~     The purpose of the COAST clinical study data will be to utilize and to gain approval for~     commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).~   "
70651|NCT02132598|"~     This is an open-label phase II clinical trial designed to allow a preliminary assessment of~     the efficacy and safety of cabozantinib in unselected Non-Small Cell Lung Cancer (NSCLC)~     patients with metastases to the brain and in the subset of patients with c-MET amplified~     Non-Small Cell Lung Cancer with metastases to the brain. Previously treated patients with~     non-squamous NSCLC who have had brain metastases at any point in their treatment history are~     eligible for enrollment on this clinical trial. Patients with clinically asymptomatic~     untreated brain metastases will be allowed on trial at the discretion of the treating~     investigator. Patients who have undergone treatment for their brain metastases with~     Whole-Brain Radiation Therapy (WBRT), stereotactic radiosurgery (SRS) or surgery must be~     clinically stable and recovered from all procedures at the time of study enrollment.~   "
70652|NCT02132585|"~     Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of~     myocardial velocities and deformation parameters such as strain and strain rate (SR). It is~     demonstrated that these parameters provide important insights into systolic and diastolic~     function, ischaemia, myocardial mechanics and many other pathophysiological processes of the~     heart. In this preliminary study, we investigated the role of STE in detection of early~     ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory~     fitness.~   "
70653|NCT02132572|"~     Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of~     reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)~   "
72205|NCT02112266|"~     One Aim of the current study is to better understand why some patients suffering from~     depression do not seek professional help by doctors but in the internet.~      Furthermore patients with depression will receive Online Therapy for depression. Aim of this~     part of the study is to investigate whether quality of life changes accordingly to~     improvement of symptoms after online therapy.~   "
70654|NCT02132559|"~     Women with low ovarian reserve typically respond less well to the drugs used to stimulate~     the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to~     fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen~     for poor responders is currently unknown.~      Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor~     responders, and is now utilized by approximately one third of all IVF centers world-wide.~     However, the current clinical evidence for DHEA on improvement of ovarian response and IVF~     outcome is insufficient. The validity of the results of the former studies, especially the~     varied inclusion criteria used to specify poor responders, is a subject of debate. Recently~     a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by~     the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have~     been performed study to evaluate the potential effects of DHEA supplementation according to~     these standards.~      The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of~     poor ovarian responders that fulfill the Bologna criteria.~   "
70655|NCT02132546|"~     The aim of this clinical trial was to evaluate through a clinical spectrophotometric~     analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration~     system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery.~     The efficacy of the products and the patient's opinion and acceptance were also assessed.~   "
70656|NCT02132533|"~     The purpose of this study is to determine if nifedipine treatment of women in preterm labor~     receiving corticosteroids results in postponement of delivery when compared to placebo.~   "
70657|NCT02132520|"~     The purpose of this study is to determine whether the combination of low frequency~     repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer~     interface (BCI) training is effective for enhancing motor recovery after stroke.~      The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects~     receiving supplementary rTMS and BCI training will show greater functional improvements in~     hand motor ability over time as well as recovery of normal motor connectivity patterns.~   "
70658|NCT02132507|"~     The purpose of the study is to evaluate a new technology for functional neuroimaging using~     electroencephalography (EEG) and MRI in studying epilepsy.~   "
70659|NCT02132494|"~     The relationship between physical activity and academic performance has received widespread~     attention owing to the pressure on schools to graduate pupils who meet accepted academic~     standards. As important, there are global concerns regarding the increased prevalence of~     lifestyle-related non-communicable diseases (NCDs). First, Norway has a history of mediocre~     scores on international comparative academic performance tests such as Trends in~     International Mathematics and Science Study (TIMSS) and the Programme for International~     Student Assessment (PISA) [1]. It is therefore important to develop and evaluate strategic~     programs that may enhance pupil's academic performance. It is increasingly evident that a~     physical activity strategy that brings about enhanced cognitive function, better blood flow,~     and more, plays a key role in this effort [2]. Second, the prevalence of NCDs, such as~     diabetes mellitus type 2, is increasing worldwide, and such NCDs affect people of all ages~     [3]. Hence, healthcare costs are escalating to unaffordable levels. The best means to deal~     with this immense problem is through primary prevention, and physical activity is a powerful~     common denominator known to play a key role in preventing a host of NCDs [4].~      Consequently, both World Health Organization (WHO) and the Norwegian health authorities call~     for effective primary prevention strategies to promote physical activity in children and~     adolescents [5, 6]. Prop. 90 L (2010-2011) Act on public health work [6] emphasizes that~     physical activity in school can benefit both the learning process and public health~     prevention.~      Therefore, the objective of the ASK-study is to investigate the effects on academic~     performance of 60 minutes of daily physical activity during one school year. Furthermore,~     due to the complexity in the relationship between physical activity and academic~     performance, it is necessary to identify possible mediating and moderating variables as~     cognitive performance, quality of life (QoL), classroom behavior, motor skills and~     motivation. Also, we aim to investigate changes in risk factors related to NCDs and factors~     that influence NSDs, such as physical activity, sedentary behavior and health-related~     fitness.~      In addition a qualitative part of the ASK-Study will be conducted to get an in-depth~     understanding of the children's embodied experiences and the meaning of the social learning~     culture in school physical activity (PA). This will give us an in-depth description of the~     intervention context, offer insight in how the intervention possibly influences children's~     overall development and enables us to estimate potential long term effects of the~     intervention.~      If successful, the ASK cluster-randomized controlled trial (RCT) could provide much needed~     solutions to enhancing schoolchildren's academic performance and position the school as an~     effective setting for a massive public health intervention concerning the prevention of~     NCDs.~   "
70660|NCT02132481|"~     The primary goal of the proposed trial is to examine the effect of combining frequent~     self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via~     Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from~     drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge. We~     will recruit 400 participants at discharge (both planned or unplanned) from Illinois'~     largest treatment organization and randomly assign them in a 2 x 2 factorial design to~     receive EMA only, EMI only, combined EMA+EMI, or neither (control). Participants in the 3~     EMA and EMI groups will receive a smartphone and training after discharge. To help them~     self-monitor, individuals in the EMA groups will be randomly signaled 6 times daily for 6~     months and asked to record their recent substance use, HIV risk behaviors (e.g., needle use,~     unprotected sex) and exposure to internal and external protective and risk factors, then to~     rate the extent to which these factors support their recovery or make them want to use drugs~     or alcohol. Individuals in the EMI groups will have 24/7 access to a smartphone recovery~     support system. In the combined EMA+EMI group, participants will receive feedback directly~     following completion of each 2-3 minute EMA, and EMA responses will be used to encourage EMI~     utilization. The primary hypotheses are~      H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be~     associated with more days of abstinence from drugs and alcohol over the 6 months post~     discharge.~      H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with~     fewer HIV risk behaviors over the 6 months post discharge.~      H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and~     c) their interaction on HIV Risk behavior at 6 months post discharge.~   "
70661|NCT02132468|"~     This study will investigate the safety, symptoms and biomarker response of subjects with~     biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic~     PNETs or GI-NETs with elevated biochemical markers who have relapsed during or after~     receiving prior standard of care therapies, including octreotide, chemotherapy or targeted~     therapy.~   "
70662|NCT02132455|"~     The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find~     early precancerous growth in the colon (polyps) and remove them before they turn into~     cancer. The doctor performing the procedure will first advance the colonoscope to the end of~     the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the~     colonoscope. The period of time that the doctor spent examining the colon called withdrawal~     time. Usually doctors will spend at least 6 minutes examining the colon after he reached~     the cecum. The investigators are proposing that dedicating half of the withdrawal time~     during colonoscopy in examining the right side of the colon, will increase the detection of~     polyps in the right side of the colon.~   "
70663|NCT02132442|"~     This study is designed to study the effect of vitamin D intake on the severity of fatty~     liver and poor glucose control in patients with type 2 diabetes and fatty liver disease.~   "
70664|NCT02132429|"~     The primary purpose of this study is to evaluate the safety and tolerability of multiple~     oral doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the~     secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG~     333 after multiple oral doses in healthy subjects and migraine subjects, as well as~     characterize the effect of multiple doses of AMG 333 on increases in blood pressure (BP)~     induced by the cold pressor test (CPT) in healthy subjects.~   "
70665|NCT02132416|"~     The purpose of this prospective controlled study is to determine whether surgical management~     of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for~     and the time spent on ventilator compared to a group treated without operation.~   "
70666|NCT02132403|"~     This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that~     targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in~     yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor~     cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous~     drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels)~     in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a~     standard 3+3 design. Treatment continues until disease progression, unacceptable toxicity,~     physician discretion, or patient refusal.~   "
70667|NCT02132390|"~     Compare the potential benefits of adjuvant toremifene with or without goserelin in~     premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied~     with or without chemotherapy induced amenorrhoea.~   "
72259|NCT02111564|"~     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared~     with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and~     VTE-related death post-hospital discharge in high-risk, medically ill patients.~   "
70669|NCT02132351|"~     Due to the limitations and the invasive nature of liver biopsy, there has been extensive~     interest in developing non-invasive tests to measure liver fibrosis (1). These are~     alternatives to liver biopsy that can be used in clinical practice, with benefits in terms~     of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include~     radiological studies, transient elastography (TE), and serum markers. We aim at studying~     acceptability, reliability, applicability and practical aspects of invasive and noninvasive~     methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.~   "
70670|NCT02132338|"~     With health education, patients will have knowledge of the disease and may modify their~     attitudes to diabetes. Have a different behavior, will perform self-management of their~     health. Will adhere to physical activity, the better control of the disease and have quality~     of life. Empower the patient through the educational practices.~   "
70671|NCT02132325|"~     This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life~     Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in~     the outpatient medical oncology setting. Investigators hypothesize that providing dignity~     therapy to this population will be feasible.~   "
70672|NCT02132312|"~     The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when~     administered in irrigation solution during cataract extraction on intraoperative pupil~     diameter, acute postoperative pain, and safety in children birth through 3 years.~   "
70673|NCT02132299|"~     This trial will evaluate whether relatively non-immune populations in endemic countries can~     effectively generate significant cellular and humoral immune responses that confer~     protection against P. falciparum infection after inoculation of aseptic, purified, vialed,~     metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum~     sporozoites (PfSPZ Vaccine) administered intravenously (IV).~   "
70674|NCT02132286|"~     Major depressive disorder (MDD) is a highly prevalent, chronic and/or recurrent condition~     with substantial morbidity and mortality. It is one of the leading causes of disability~     worldwide. Despite significant advances in pharmacological treatment for depression over the~     last two decades, a significant proportion of patients (10-20%) are resistant to currently~     available treatment. The development of new effective treatment for depression is limited by~     the fact that MDD is a heterogeneous disorder with subgroups based on variations in~     etiological factors and treatment response. Functional magnetic resonance imaging (fMRI)~     approaches offer promise in the prediction and evaluation of clinical response of~     antidepressant treatment.~      Previous fMRI studies have identified increased activity in dorso-lateral prefrontal cortex~     (DLPFC) and decreased amygdala activity from the baseline as imaging markers of~     antidepressant response in patients with MDD. However, these studies have examined MDD as a~     homogenous group without specifying the type of patient group, and brain regions as a priori~     hypothesis.We therefore need studies using combined genetics and neuroimaging measures as~     biomarkers in the prediction and evaluation of clinical response to antidepressants. In this~     study we attempted to determine imaging clinical efficacy markers in previously defined~     brain regions (amygdala and prefrontal regions) for two classes of antidepressants~     (citalopram and quetiapine extended release (XR)) with differential action on serotonin~     transporter inhibition in a subgroup of MDD patients with high risk allele ( S/Lg) of~     serotonin transporter gene polymorphism.~   "
70675|NCT02132273|"~     The investigators hypothesize that use of an educational story with pictures illustrating~     overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple~     narrative will be a cost-effective, readily accepted intervention that will contribute to~     successful completion of sleep studies among children with disabilities. Children who have~     been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled~     and randomized to either recieve usual care (discussion of polysomnography with referring~     clinicians) or educational story intervention. Both groups of participants will be asked to~     complete questionnaries before and after the sleep study. Set-up for the sleep study will be~     videotaped so that behavior of the child can be evaluated. The investigators will evaluate~     whether successful study completion differs between the two groups.~   "
70676|NCT02132260|"~     The objective of this study is to compare the efficacy and safety of the test formulation of~     Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week~     study in patients with tinea pedis.~   "
70677|NCT02132247|"~     The primary purpose of this study is to determine whether Flector Patch is safe for use in~     children. The secondary purpose is to assess blood levels of diclofenac, the active~     ingredient in Flector Patch.~   "
70678|NCT02132234|"~     The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha~     (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in~     patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.~   "
70679|NCT02132221|"~     This research is being done to better understand how to help patients who are not receiving~     enough relief from opioid prescription medications for chronic non-cancer pain. Opioids are~     a group of medications that includes morphine, oxycodone-, hydrocodone-, etc. These~     medications are also called narcotics. Research has shown that patients not benefiting from~     their opioid prescription medication often feel better when they stop taking it. However,~     stopping or reducing pain medications can be a difficult transition. Although they do not~     have much benefit from their medication, many patients are afraid to stop because they feel~     these medications are the only things giving them a bit of relief. Different strategies can~     be used to help patients through the period of tapering and it is not clear which one is~     best. The investigators will test a specific approach used during regular care in the~     clinic: cognitive therapy.~   "
70680|NCT02132208|"~     A prospective single-centre non-comparative non-interventional open study has been designed~     to validate, in a target number of 100 trauma patients, the correlation between TICCS~     evaluated on the site of injury and thromboelastography made on a whole blood sample taken~     at the latest 30 min after patient's arrival in the resuscitation room.~      The aim of this study was to evaluate the capacity to discriminate trauma patients suffering~     from active bleeding and arly acute coagulopathy of trauma and needing Damage control~     resuscitation from those without this aggravating combination with a new purely clinical~     easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).~   "
70681|NCT02132195|"~     In childhood nephrotic syndrome, the kidneys leak protein, causing body swelling and a~     variety of possible complications such as infection, blood clots, and kidney failure. The~     first-line treatment for nephrotic syndrome is corticosteroids. Many children respond to~     prednisone treatment, but the disease comes back (relapses) when the prednisone is stopped~     or the dose is reduced. Children with frequently relapsing or steroid dependent nephrotic~     syndrome are at risk for toxicity from frequent exposure to corticosteroids.~      Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic~     syndrome involves a variety of medications that suppress the immune system, which can~     produce serious side effects. We propose a study to examine the effects of a different~     medication, ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body.~     Recently, in adult studies, ACTH has been shown to be effective for the treatment of~     nephrotic syndrome. It has also been shown to have mild and reversible side effects. ACTH is~     potentially an attractive therapeutic alternative for the treatment of frequently relapsing~     and steroid dependent nephrotic syndrome in children. Our study will randomly assign~     patients with frequently relapsing or steroid dependent nephrotic syndrome to either ACTH~     treatment or no treatment. This will allow us to study the effects of ACTH on this disease~     and its side effects, by comparing how patients do on ACTH treatment versus no treatment. We~     hypothesize that ACTH gel is superior to no treatment in maintaining remission in children~     with frequently relapsing or steroid dependent nephrotic syndrome.~   "
70682|NCT02132182|"~     The purpose of this study is to identify phenotypic (cell surface receptor expression) and~     functional differences in monocyte populations in humans with osteosarcoma as compared to~     published historical data on normal human monocyte values.~      The biologic similarity between canine and human osteosarcoma makes it a disease model that~     holds promise for translational research possibilities. The phenotypic and functional~     differences the investigators expect to find in canine and human monocytes between normal~     and osteosarcoma subjects in this pilot work will allow us to launch a program of~     investigations to further their understanding as to what characteristics are associated with~     improved survival in canine and human osteosarcoma. Such data will represent the foundation~     upon which the investigators can plan future investigations designed to exploit the~     potential anti-tumor capabilities of monocytes and macrophages in canine and human~     osteosarcoma.~   "
70683|NCT02132169|"~     The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in~     Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic~     disease (including allergic conjunctivitis).~   "
70684|NCT02132143|"~     The purpose of this study compares chemoradiation and sequential chemoradiation about Lung~     adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic~     method is better for the patients.~   "
70685|NCT02132130|"~     The goal of the study is to evaluate the safety, tolerability, and the potential ability of~     CGF166 delivered through IL-infusion to improve hearing and vestibular function. CGF166 is a~     recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal~     transcription factor (Hath1).~   "
70686|NCT02132117|"~     This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream~     1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to~     severe facial erythema associated with rosacea.~   "
70687|NCT02132104|"~     The purpose of the study is to evaluate whether human amnion graft reduces the reformation~     of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.~   "
70688|NCT02132091|"~     Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover~     trial. The trial will consist of two, three-week periods of intermittent fasting, where~     subjects receive either antioxidant supplementation or placebo, the ordering of which will~     be randomly determined. A one-week preconditioning will precede each invention period, and a~     two week wash-out period will follow the first intervention period. Serum-based assays~     will be performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins,~     and markers of mitochondrial biogenesis and aging.~      The investigators hypothesize that an intermittent fasting diet in healthy young volunteers~     will improve these markers of cellular aging and that these beneficial effects will be~     abrogated by the supplementation of antioxidants. This study is a proof-of-principle study~     that will shed light on the mechanism and effects of IF as an anti-aging dietary~     intervention in the absence of weight loss. It will inform the design of dietary~     interventions that are both effective in improving markers of aging and feasible for~     patients to practice on a long-term basis.~   "
70689|NCT02132078|"~     The purpose of this study is to assess incidence, treatment modalities and outcome of~     complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant~     recipients (LTRs) in order to establish improved treatment strategies in this high risk~     patient collective.~   "
70690|NCT02132065|"~     Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy,~     assessment of benefit and opioid reduction.~      Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which~     infiltrates local anesthetic between the internal oblique and transverse abdominis muscles~     and provides analgesia to the parietal peritoneum as well as the skin and muscles of the~     anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane~     block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional~     anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12)~     abdominal wall bilaterally using a four-point single-shot technique.~      Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain~     may have harmful physiologic, psychological consequences which potentially increase the~     morbidity and mortality (4,5). It has been recognized that inadequately treated~     postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7).~     Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).~      Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and~     the need of morphine postoperatively after radical nephrectomy.~      Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to~     routine analgesic. To assess the difference in morphine usage in the first 48 hours after~     radical nephrectomy with or without applying of unilaterally dual TAP block.~   "
70691|NCT02132052|"~     Investigators hypothesize that there are specific characteristic of each cognitive and motor~     condition that can be defined using brains scans.~   "
70692|NCT02132039|"~     The study aims to compare the efficacy of a home-based structured exercise programme~     (12-step sitting Tai Chi) involving both persons with dementia and their caregivers with a~     standard non-exercise social contact control in treating depression among caregivers. The~     effects of exercise on their cognition, quality of life and balance ability are also~     assessed. We will also examine if BDNF polymorphisms modulate mood changes in response to~     exercise intervention. Focus groups will be organised at the end to find out the~     facilitators and barriers in taking up exercise. The findings may offer an avenue of~     intervention by providing a low cost, relatively safe and effective treatment for dementia~     caregivers, which may in turn benefit the persons with dementia.~   "
70693|NCT02132026|"~     Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes~     narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure~     and sudden death. It is the commonest valve disease requiring surgery in the developed world~     and as the population becomes increasingly older, it is predicted that the prevalence of~     aortic stenosis will double in the next 20 years. Currently the only treatment is~     replacement of the aortic valve. Whilst this is excellent treatment, not everyone is~     suitable for it.~      The primary objective of our study is to determine whether 2 drugs used in the treatment of~     osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic~     stenosis. This is on the basis that studies have suggested that altered regulation of~     calcium metabolism may be an important mechanism perpetuating the disease. Both drugs work~     by reducing calcium release into the bloodstream from bones and therefore calcification of~     the aortic valve.~      150 patients will therefore be randomly allocated to either of the trial drugs which are~     denosumab,the bisphosphonate (alendronic acid), or a placebo.~      Positron Emission Tomography (PET) scanning is a technique where biochemically active~     molecules are injected and are taken up at sites of ongoing calcification activity where~     they emit radiation and can be detected by the PET scanner. We have previously shown that~     this technique can demonstrate areas of newly developing calcification on an aortic valve.~      We therefore propose that patients receiving bisphosphonates or denosumab will have reduced~     evidence of active calcification and slower progression of their disease at two years as~     assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of~     calcium on the aortic valve measured using Computed Tomography [CT] ).~      The data from this study will then be used to design a larger trial.~   "
70694|NCT02132013|"~     The purpose of this study is to evaluate the effects and efficacy of dietary sodium~     restriction by mean of a new healthcare approach in patients with chronic kidney disease.~     The test persons in the intervention group are actively supported to adhere to a restricted~     sodium diet with a structured self-regulation program to implement sodium recommendations~     that are in current guidelines.~   "
70695|NCT02132000|"~     In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of~     tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated~     derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought~     to compare the efficacy and tolerability of toremifene and tamoxifen therapy in~     premenopausal patients with operable,estrogen and/or progesterone receptor positive breast~     cancer patients.~   "
70696|NCT02131987|"~     Between January 1 2006 and December 31 2013, at our department 324 patients underwent~     hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis~     (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with~     pathological fractures and HA performed with direct lateral approach were excluded. A~     retrospective cohort study were conducted. Patients with prosthetic dislocation formed one~     group and patients without dislocation formed the control group.~      As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these~     were performed patient started weight bearing as soon as possible. Clinical data regarding~     patient demographics, details of the surgical procedure and the medical comorbidities were~     collected by the use of patient and operative records. Radiological analysis with position~     evaluation was performed using the post surgery radiographs by measuring Wiberg angle,~     inequality of leg length and femoral offset of the prostheses and compared with non-operated~     hip joint using the post surgery x-ray images.~      Our hypothesis were that patients with single- or recurrent dislocations had shortened~     postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.~   "
70697|NCT02131974|"~     The purpose of this research study is to help determine if the cuff of an endotracheal tube~     ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if~     visualization of this tube corresponds with correct tube depth. You are being asked to~     participate because you will be undergoing a cardiac catherization procedure which will~     involve endotracheal intubation.~      Ultrasound is a safe technology that your doctor could possibly use to see the breathing~     tube. Right now, x-rays, which come with their own risks, are being used for this purpose.~     We are trying to see if we can avoid using x-rays.~      This is a local study with 1 location. The study will enroll a total of 71 people. There is~     no sponsor for this study.~   "
70698|NCT02131961|"~     This study is designed to evaluate the ability to modify a contact cast system so that~     topical medications can be applied daily to an underlying wound in patients with diabetic~     plantar ulcers. The modification of the cast will be done by making an opening where the~     wound is located in the contact cast system. A contact cast system is a device that will~     reduce the pressure in the area where the wound is located.~   "
70699|NCT02131948|"~     It is well known that the hormone insulin lowers blood glucose in part by acting directly on~     the liver and reducing hepatic glucose production. Animal studies have shown that the~     hormone insulin can act on the brain to indirectly lower glucose production by the liver. We~     aim to test whether this is true in humans by giving insulin intranasally. It has previously~     been shown that a nasal spray can deliver insulin directly to the brain without affecting~     circulating insulin concentration.~   "
70700|NCT02131935|"~     The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of~     endothelial dysfunction could predict occurrence of ISR after percutaneous coronary~     intervention (PCI).~   "
70701|NCT02131922|"~     Hypertensive patients with chronic periodontitis will be randomized to either intensive~     treatment or supragingival hygienic treatment and the effects on blood pressure will be~     identified.~   "
70702|NCT02131909|"~     This is a randomized and comparative prospective test, monocentric and controlled (mirror~     therapy versus bimanual rehabilitation exercises), in single-blind (investigator and~     occupational therapist  1  do not know the type of rehabilitation performed).~   "
70752|NCT02131259|"~     In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the~     Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data~     for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a~     new substance, results of PMS need to be submitted as a part of reexamination dossier to the~     Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).~   "
70703|NCT02131896|"~     Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic~     control: normal glucose homeostasis, normal lipid profile, normal blood pressure and~     desirable weight. Controlled nutritional diet, as introduced by the professional committees~     aims at achieving better general health condition.~      There is a growing body of evidence showing that Mediterranean diet has a major role in~     prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of~     Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception~     of one Italian study.~      Six months after education to consume Mediterranean diet in a cohort of 96 children with~     type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased~     dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol~     ratio.~      The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the~     accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid~     profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters,~     endothelial function and anthropometric parameters 12 months following diagnosis.~      The study designed as a two parallel arms, randomized, single center, intervention study.~      Patients enrolled to the study will be randomly assigned, to one of the following groups in~     a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive~     nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the~     interventional arm will receive regular nutritional instructions in accordance with the~     accepted nutritional guidelines~   "
70704|NCT02131883|"~     Background:~      The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This~     functional disorder is difficult for medical doctors to treat, the course of the disorder is~     often chronic, and that is costly for the social and health care systems as well as for the~     patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual~     cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised~     controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for~     patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been~     conducted.~      Aims:~      1) to examine the effectiveness of group-CBT for patients with severe health anxiety~     compared to a wait-list group receiving usual care, 2) to perform a categorical and~     dimensional assessment of personality, 3) to examine predictors of outcome especially~     comorbid personality disorders, 4) to examine the relation between personality, illness~     perception and treatment outcome, 5) to compare the cost-effectiveness of these two~     treatments, 6) at a 2 years follow up to examine the course and long-term effectiveness of~     group-CBT for patients with severe health anxiety and some also followed by psychological~     treatment for comorbid personality disorders.~      Main hypothesis:~      Patients with severe HA who have received group CBT will at 6-month follow-up compared to a~     wait-list group receiving usual care show a significantly reduction in health anxiety.~      Methods:~      84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry~     in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to~     either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or~     wait-list with usual care for 9 months.~      Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65~     years, Danish speaking, informed consent.~      Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis,~     a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication.~      Diagnostic assessment:~      The patients are included using research criteria for severe health anxiety (for ICD-11) and~     semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II~     (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety~     disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and~     traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section~     III.~      Outcome measures:~      The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7~     (WI-7), with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe~     health anxiety present 6 months after end of treatment.~      The secondary outcome measures are questionnaires for health anxiety (HAI), general~     psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning~     (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption~     (CAGE) and register data for number of sick days and use of social and health care and a~     blinded global assessment of functioning (F-GAF).~      Time frame:~      Data wil be analysed, and results wil be disseminated from 2016.~   "
70705|NCT02131870|"~     The purpose of this study is to study the effect of a probiotic product on iron absorption~     in healthy females of child-bearing age.~   "
70706|NCT02131857|"~     Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic~      Hypothesis 2: Participants in the mindfulness intervention will show an increased level of~     quality of life post intervention with the Mindfulness course~      Hypothesis 3. Levels of mindfulness:~      Participants in the mindfulness intervention will report increased mindfulness levels~     post-program completion as compared to pre-program completion~      Hypothesis 4. Levels of stress:~      Participants in the mindfulness intervention will report lower levels of stress post-program~     completion as compared with pre-program commencement.~      Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program:~     Residual symptoms of depression are a risk factor for relapse of depression. Post -program~     participants of mindfulness will purport fewer residual depressive symptoms compared with~     pre-program.~      Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As~     mindfulness intervention has been shown to modulate immune system it may improve physical~     aspects of CF including markers of inflammation and markers of lung disease (lung function~     tests and rate of pulmonary exacerbations) and nutritional state.~   "
70707|NCT02131844|"~     Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is~     considered an important component of postoperative care after colorectal surgery. Having a~     health professional dedicated to facilitate early mobilization has the potential to enhance~     postoperative recovery by preventing the negative effects of prolonged bed rest (e.g.~     increased risk for complications, muscle loss, deconditioning and functional decline);~     however, the need to implement this resource-intensive approach is not evidence based. This~     study aims to contribute evidence about the role of facilitated early mobilization as a~     strategy to enhance recovery after colorectal surgery.~   "
70708|NCT02131831|"~     There are several factors that influence telomere length in patients with cirrhosis, such as~     metabolic derangements and infectious etiologies, The aim of the study is to compare~     telomere length and other parameters related to genetic instability in telomere/ telomerase~     system, in peripheral blood lymphocytes in cirrhosis from different etiologies.~   "
70709|NCT02131818|"~     The purpose of this study is to determine amoxicillin is effective in the prevention of~     wound infection in normal labor.~   "
70710|NCT02131805|"~     The purpose of this study is to assess the effectiveness of electronic skin surface~     brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a~     new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy~     System. The investigators want to understand what effects, good and/or bad this device for~     delivering brachytherapy has on your skin cancer. The investigators also want to assess the~     safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin~     imaging with clinical response to ESSB.~   "
70711|NCT02131792|"~     This study was conducted to evaluate results of slanted recession of the lateral rectus~     muscle for intermittent exotropia with convergence weakness~   "
70712|NCT02131779|"~     The objective of the Prostate Cancer Education in African American Churches project is to~     develop and evaluate a spiritually-based educational intervention for Informed Decision~     Making (IDM) for prostate cancer screening to be delivered to African American men in church~     settings.~   "
70713|NCT02131766|"~     The purpose of this study is to use the USS Virginia Closed-Loop system for overnight~     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate~     the system's ability to significantly improve blood glucose levels. This protocol will test~     the feasibility of bedside closed-loop control - an approach comprised of standard~     sensor-augmented pump therapy during the day using off-the-shelf devices and overnight~     closed-loop control using experimental devices in an outpatient setting. The rationale for~     this study is as follows: we anticipate that closed-loop control may ultimately be adopted~     by patients with T1DM in a selective manner. Patient may choose to start using these systems~     for overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while~     asleep. To test this paradigm of bedside closed-loop control, subjects will be studied~     with continuous glucose monitoring (CGM)-augmented usual pump therapy during the day~     followed by overnight use of USS Virginia Closed Loop Control.~   "
70714|NCT02131753|"~     The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle~     of cladribine in patients with hairy cell leukemia requiring treatment.~      They have to be untreated so far or may be pretreated with alpha-interferon.~   "
70753|NCT02131246|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect~     of the investigated drug on the body) properties of faster-acting insulin aspart in subjects~     with Type 1 diabetes.~   "
70717|NCT02131714|"~     Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of~     temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of~     this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a~     short-term conservative treatment for the management of temporomandibular disorders. This~     study is a randomized controlled clinical trial where 84 participants were diagnosed with~     myofascial pain according to the Research Diagnostic Criteria for Temporomandibular~     Disorders (RDC/TMD), with a mean age of 44 years old ranging from 18 to 76 years old. These~     individuals were asked about parafunctional habits and the treatment was applied by~     providing an explanation concerning the role of pain, possible aetiological factors of the~     patient's TMD, the relationship between chronic pain and psychosocial distress, and its~     benign character. They also had to perform once daily application of hot packs on both sides~     of the face for 20 minutes and after that they must perform active free therapeutic exercise~     of mouth opening for 10 times. The pressure pain threshold of the masseter and temporalis~     muscles and the lateral pole of the condyle were obtained at baseline (T0), between 15 and~     30 days after (T1) and at 75 to 90 days after (T2) representing the end of the treatment.~     Two groups of subjects were obtained. The first was considered the study group (SG) and~     included those who underwent the treatment proposed. The control group (CG) consisted of~     participants who did not undergo treatment because they did not believe in it.~   "
70718|NCT02131701|"~     The aim of the study is to evaluate the long-term effects of a prescription of exercise~     versus a group-based training program on aerobic fitness, muscle strength and metabolic~     variables in subjects with poor physical fitness. The participants are further stratified~     for a family-history of type 2 diabetes. The number of subjects in each group of~     intervention is planned to be 150, aged 30-70 years and non-diabetic.~      Intervention: All study subjects take part in two individual sessions for exercise~     prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The~     prescription group perform exercise by themselves, while the training group will be offered~     supervised physical training, including both endurance training and training in gym twice a~     week during 12 months.~      The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.~      Methods of follow-up: At the study visits physical fitness will be measured by a 2 km~     walking test, glucose tolerance by oral glucose tolerance test with measurement of glucose~     and insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle,~     physical activity, cardiovascular disease and medication.~      In the training group 30 subjects with and 30 subjects without a family history of type 2~     diabetes will participate in a sub-study including muscle- and fat-biopsy before the start~     of the study, after 1 and 5 years.~   "
70719|NCT02131688|"~     The purpose of this study is to determine the maximum tolerated dose,the safety and~     effectiveness of Mitoxantrone Hydrochloride Liposome Injection.~   "
70720|NCT02131675|"~     Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an~     inability to synthesize insulin. Connecting peptide (C-peptide) is formed from the same~     precursor as insulin and is produced in equimolar amounts as insulin. There are several~     clinical trials currently being performed to explore the possibility of beta-cell~     preservation or regeneration. Most children are not eligible for these trials because it is~     often presumed that C-peptide levels will decrease and become undetectable after years of~     having type 1 diabetes. Several studies in the adult population have demonstrated that~     C-peptide may remain measureable in patients who have had diabetes for up to 50 years after~     diagnosis. Recently, it was demonstrated that 10% of adult patients who have had type 1~     diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an~     ultrasensitive assay. The levels were lower in patients who had diabetes for a longer time.~     This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT)~     and NHANES trial. No studies have been performed exclusively in pediatric patients~     Hypothesis The investigators hypothesize that C-peptide should be detectable in the sera of~     pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as >~     20 years after diagnosis. The investigators also hypothesize that since their patient~     population has had diabetes for less time as compared to adults, the levels of C-peptide~     should be higher than reported for adults and that a greater proportion of patients in the~     pediatric population will have detectable C-peptide levels as compared to adults.~   "
70721|NCT02131662|"~     The study is performed to assess the efficacy and safety of different doses of BAY1002670 in~     subjects with uterine fibroids. The dose-response relationship will be evaluated. Further,~     the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for~     BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the~     interchangeability of menstrual pictogram and alkaline hematin method for the judgement of~     menstrual blood loss will be assessed.~   "
70722|NCT02131649|"~     The PROPS trial is for men being considered for radiotherapy due to the suspicion that their~     prostate cancer has recurred following the surgical removal of their prostate~     (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA)~     blood tests. Only men who demonstrate the absence of disease on standard imaging scans~     (Computed Tomography (CT) and bone scans) will be invited to participate.~      This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during~     Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better~     predict who will benefit from radiotherapy by identifying the source of cancer recurrence.~     This will be determined by measuring the number of men who have disease identified outside~     of the prostate bed (the small pocket or depression where the prostate used to be) on their~     18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate~     cancer that may have spread into lymph nodes or bone, it may potentially identify areas of~     prostate cancer spread not seen with standard imaging.~   "
70723|NCT02131636|"~     This study will evaluate the safety and efficacy of AGN-199201 once daily compared to~     vehicle for the treatment of persistent moderate to severe facial erythema associated with~     rosacea.~   "
70724|NCT02131623|"~     The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment~     measure of itching) prior to the analysis of longitudinal treatment effect data being~     generated in ongoing clinical trials.~   "
70725|NCT02131610|"~     Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic~     dysfunction in OSA are linked with accelerated cardiovascular morbidity.~   "
70729|NCT02131558|"~     Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full~     bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent~     dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be~     visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG,~     sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor,~     will be identified. SLNs will be surgically removed and provided to Pathology for~     evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with~     routine medical care for these patients, and given to Pathology for evaluation. A positive~     SLN may be the most accurate identifier of the extra-uterine spread of disease, and will~     provide information about the extent of surgical node removal necessary.~   "
70730|NCT02131545|"~     Quetiapine, a second generation antipsychotic, is only available as oral tablets. However,~     topical and rectal formulations have been produced in compounding pharmacies. There is no~     data available suggesting that topical or rectal formulations provide serum levels similar~     to oral medication. In the clinical setting, when oral administration of quetiapine is not~     possible (for example, when a patient is extremely ill physically or mentally or both),~     clinicians and pharmacists have collaborated in such cases and have at times had to~     administer quetiapine compounded in other dosage formulations such as rectal or topical~     formulations. Despite clinical effectiveness of these &quot;other&quot; formulations, there~     are no available studies that have investigated blood levels of the drug other than the oral~     form. The investigators are therefore designing this pharmacokinetic study to evaluate the~     the systemic absorption of quetiapine in oral, rectal and topical formulations. If the~     investigators are able to demonstrate detectable levels from rectal and topical quetiapine~     formulations compared to the oral form, this knowledge will enhance clinical psychiatric~     practice by providing a more broad route of administration for quetiapine which is a~     commonly used drug for psychiatric symptoms.~   "
70731|NCT02131532|"~     Stroke is a leading cause of adult disability in the community. Fatigue affects about a~     third of stroke survivors. It results in difficulty taking part in everyday activities, and~     increases risk of hospitalization and death after stroke. Despite of its high prevalence and~     distressing consequences, there is no effective treatment.~      Psychological interventions have improved fatigue in patients with other conditions such as~     multiple sclerosis. These interventions primarily target patients' beliefs about overcoming~     fatigue and their physical activities in daily life. Also studies indicated that post-stroke~     fatigue is associated with mood. Based on this knowledge, the investigator has designed a~     brief psychological intervention for post-stroke fatigue.~      The current study is a feasibility study to test the adequacy of intervention manuals and~     the feasibility of trial processes. This study will need 12 stroke survivors who have~     post-stroke fatigue and are over three months but within two years after their stroke.~     Stroke survivors with severe depression or having insufficient capability in cognition or~     communication will not be included. The investigator will check their eligibility by~     questionnaires and interviews and then invite eligible people to take part in the study.~      This intervention will be delivered by a therapist (a clinical psychologist) to each~     participant through six face-to-face therapy sessions. Each session will be about one hour~     and be two weeks' apart. During the sessions, participants will discuss with the therapist~     their fatigue problems, and, with the support from the therapist, work out ways to solve~     their problems. One month after the last face-to-face session, each participant will receive~     a feedback session by telephone from the therapist. Each participant will be followed up to~     three months after the last face-to-face session.~      After all participants complete their feedback sessions, the investigator will invite them~     to a group meeting to share their experiences of taking part in this trial and makes~     suggestions as how their experiences of this intervention, and also of this trial, could be~     improved.~   "
70732|NCT02131519|"~     Central venous access may be essential in pediatric patients for fluid and a blood product~     administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic~     monitoring. Obtaining central venous access in pediatric patients can be challenging,~     failure rates in pediatric patients range from 5% to 19% with reported complication rates~     from 2,5% to 22% The landmark technique has been standard approach for many years. In~     comparison with landmark method in pediatric patients the use of ultrasound is associated~     with an increased success rate decreased operative time, reduced number of cannulation~     attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our~     success rate using ultrasound as a guidance during central vein insertion.~   "
70733|NCT02131506|"~     A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2~     positive pretreated Breast Cancer.~      Treatment Plan:~      Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is~     administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is~     defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib~     1000 mg die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30~     mg/mq & Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three~     patients will be initially enrolled in each dose level starting from level 1. If none of the~     first triplet of patients will develop DLT, the dose will be escalated to the next level for~     the subsequent three patients. If one of the first triplets of patients will develop~     first-course DLT, a maximum of 3 additional patients will be entered at the same dose level.~     The MTD is defined as the dose below that at which two patients have experienced DLT.~     Lapatinib will be self-administered by the patient in an outpatient setting at the dose of~     the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle.~     Caelyx will be administered by intravenous infusion over an exact period of 1 hour~     (preferably by a pump to guarantee a constant speed of infusion) on day~      1 of each cycle repeated every 21 days.~      STATISTICAL METHODOLOGY:~      Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their~     first treatment with Caelyx and Lapatinib.~      Evaluation of response: all patients included in the study must be assessed for response to~     treatment, even if there are major protocol treatment deviations or if they are ineligible.~      All conclusions should be based on all eligible patients. Subanalyses may then be performed~     on the basis of a subset of patients, excluding those for whom major protocol deviations~     have been identified .However, these subanalyses may not serve as the basis for drawing~     conclusions concerning treatment efficacy, and the reasons for excluding patients from the~     analysis should be clearly reported. The 95% confidence intervals should also be provided.~   "
70734|NCT02131493|"~     This study is a randomized, open-label, controlled study that will compare the efficacy of~     S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients~     with surgically resected pancreatic adenocarcinoma.~   "
70735|NCT02131480|"~     Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when~     metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,~     ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in~     first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of~     soft tissue.~      The trabectedin is a new cancer drug that has obtained marketing authorization after failure~     of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe.~     It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.~      This study aims to evaluate the usefulness of the combination of trabectedin with~     doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.~   "
70754|NCT02131233|"~     To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily~     in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with~     TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being~     tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir~     400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion~     of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.~   "
70736|NCT02131467|"~     Cervical dystonia (CD) is the most common focal dystonia. Currently there are no effective~     oral medications for the treatment of CD. While botulinum toxin injections improve symptoms,~     they require repeated injections by a trained physician and some patients stop responding to~     injections or never respond at all. Therefore, alternative treatment options for CD are~     needed. One new agent is a drug that targets glutamate receptors that are thought to be~     involved dystonia. This drug, perampanel, was originally developed for epilepsy and is~     licensed for use in the USA and Canada for treating epilepsy. The purpose of this study is~     to test the effectiveness of perampanel in treating the symptoms of CD.~   "
70737|NCT02131454|"~     Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the~     study is to determine if short training of inhalation technique in patients with obstructive~     diseases may influence the course of asthma and COPD.~   "
70738|NCT02131441|"~     Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally~     invasive compared to open liver resection, however, laparoscopic liver resection is still~     difficult and risky. Currently it is only carried out in a few large medical centers with~     slow development. The related research studies were retrospective analysis, there were no~     prospective randomized controlled multi-center study reported. Because of its relatively~     simple anatomical advantages, left liver seems to be as the best platform to ensure maximum~     safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This~     project intends to carry out a prospective randomized controlled multi-center study to look~     for evidence of safety, efficacy and minimally invasive of laparoscopic left liver~     resection, evaluate the long-term efficacy including overall survival, disease-free survival~     as well as time to disease recurrence for the left liver carcinoma.~   "
70739|NCT02131428|"~     Heart failure is the most costly diagnosis in the Medicare population. Clinical depression~     is strikingly common in heart failure patients, and not only diminishes their quality of~     life, but also is associated with a markedly increased risk of hospitalization or death.~     This study is designed to further our understanding of the behavioral and biological effects~     of depression in patients with heart failure, so that appropriate treatments can be~     developed.~   "
70740|NCT02131415|"~     This is a non-interventional, Canadian, study in patients treated with Abilify Maintena™ for~     schizophrenia followed for 24 months, with 9 visits recommended. Study assessments and~     administration of questionnaires will take place during the patient regular assessments or~     injection visits that are part of routine care. The main objective of the study is to~     describe the impact of treatment with Abilify Maintena™ on global functional status.~   "
70741|NCT02131402|"~     The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens~     handling, lens fitting characteristics and visual acuity of different hydrogel lens designs~     versus silicone hydrogel lenses~   "
70742|NCT02131389|"~     The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total~     hip replacement surgery.~   "
70743|NCT02131376|"~     Preserving kidney function during removal of a kidney tumor is becoming increasingly~     important as rates of chronic kidney disease increase. A novel modifiable factor (suture~     closure of the defect caused by tumor removal) was discovered on retrospective studies to~     account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We~     hypothesize that a randomized controlled surgical trial will show that omitting the suture~     closure both preserves renal function and will not lead to unreasonable postoperative~     complications.~   "
70744|NCT02131363|"~     This purpose of this study is to evaluate the safety and performance of a treatment kit for~     ingrowing toenail, primarily by determining the number of subjects who show a reduction in~     the severity of their ingrowing toenail.~   "
70745|NCT02131350|"~     The purpose of this study is to evaluate the mean gain in best corrected visual acuity and~     the number of intravitreal ranibizumab (IVR) injections under the combination treatment of~     IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable~     photocoagulation decreases the number of IVR injections.~   "
70746|NCT02131337|"~     EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact~     force parameters applied for pulmonary vein isolation (PVI) during AF ablation.~   "
70747|NCT02131324|"~     The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA~     (hypothalamic-pituitary-adrenal) axis as compared to Comp01 cream when applied twice daily~     for 15 days.~   "
70748|NCT02131311|"~     This study will evaluate the effectiveness of the pessary device by assessing reduction in~     urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight~     gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.~   "
70749|NCT02131298|"~     This study is designed to evaluate the potential effect of itraconazole on the~     pharmacokinetics of palbociclib.~   "
70750|NCT02131285|"~     Background: Balance control relies on accurate perception of visual, somatosensory and~     vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known~     about the ability of the sensory systems to adapt after neurological lesions reducing~     sensory impairment. The aims of the present study were to verify whether:~        1. Balance rehabilitation administered in a challenging sensory conditions would improve~          stability in upright posture~        2. the improvement in a treated sensory condition would transfer to a non treated sensory~          condition.~      Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability~     Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were~     randomly assigned to two groups. The Experimental group received balance rehabilitation~     aimed at improving motor and sensory strategies. The Control group received rehabilitation~     treatment which did not include training of sensory strategies. Persons with Multiple~     Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes~     closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway,~     velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in~     the six sensory conditions.~   "
70751|NCT02131272|"~     This trial is conducted globally. The aim of the trial is to investigate the efficacy and~     safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination~     with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in~     children and adolescents with type 2 diabetes insufficiently controlled on the maximum~     tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without~     basal insulin.~   "
70756|NCT02131207|"~     This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy~     works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves~     and a powerful magnet linked to a computer are used to create detailed pictures of areas~     inside the body. This diagnostic procedure may aid in identifying lesions in the prostate~     which may have cancer. The lesions can then be targeted during the prostate biopsy to~     improve the accuracy of identifying prostate cancer.~   "
70757|NCT02131194|"~     To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in~     inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.~   "
70758|NCT02131181|"~     The purpose of this study is to determine the incidence, long term outcome and factor~     related to postoperative delirium in elderly patients after non-cardiac surgery.~   "
70759|NCT02131168|"~     Crohn's disease and ulcerative colitis are inflammatory disorders of the gut which cause~     major life-long disability. They affect males and females, with the commonest age of onset~     in childhood, teens and early adult life. Previously restricted almost exclusively to the~     West, these conditions are becoming much more common in Asian countries, including Hong Kong~     - the cause of this dramatic change is unknown.~      The cause of IBD is widely accepted as relating to the mucosal immune response to~     stimulation from the gut bacteria, on a background of genetic susceptibility. The bacteria~     and other organisms in the gut play a central role in the development of IBD in the West.~     However it is unknown if the gut bacteria differ between Chinese patients with IBD and~     non-IBD (healthy subjects) in Hong Kong, and whether it is affected by diet or changes in~     diet. A family history is the largest risk factor for the disease. More than 50 different~     genes associated with IBD have recently been identified in the West and preliminary data~     showed that Chinese patients have a different genetic profile to Western populations.~      This project aims to explore the true incidence of IBD in Hong Kong and factors that may be~     contributing to, or causing, the increase of IBD in Hong Kong. Investigators aim to~     investigate the number of new cases of IBD within a five year period and factors that may~     account for the cases. Investigators will also study the choice of medical therapy, quality~     of life and quality of health care in patients with IBD.~   "
70760|NCT02131155|"~     This randomised, double-blind phase III trial will be performed in patients with head and~     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the~     efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who~     have received definitive chemo-radiotherapy.~   "
70761|NCT02131142|"~     The purpose of this study is to collect additional safety and effectiveness data for on the~     Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo~     coronary artery disease.~   "
70762|NCT02131129|"~     This study proposes to examine the application of rTMS for the treatment of cognitive~     dysfunction in FEP. This is an important population for study because if effective, rTMS may~     represent a preventative treatment for the development of social and vocational impairment~     that is associated with cognitive dysfunction in schizophrenia. This study will also seek to~     refine the understanding of the brain circuitry that mediates the potential pro-cognitive~     effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline~     and following the course of rTMS administration.~   "
70763|NCT02131116|"~     Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the~     treatment and recovery of patients with psychotic disorders. Impaired insight results in~     poor treatment engagement and adherence, more frequent hospitalizations, greater positive~     and negative symptoms, and poor psychosocial functioning. Addressing these complications~     early in the disease process may lead to altered illness course with better outcomes. To~     date, only a small number of nonpharmacological interventions have been developed, none of~     which adequately address poor insight during the first few years of psychotic illness.~     Further, presently available therapeutic interventions do not attend to difficulties~     associated with improved insight, such as depression. The purpose of this investigation is~     to implement a novel intervention designed to improve insight, metacognition,~     neurocognition, symptoms, and ultimately overall functioning in persons with early~     psychosis. The novel intervention will integrate a number of previously established~     therapeutic approaches, such as metacognitive, narrative, cognitive behavioral and~     motivational interviewing, and hence be labeled Integrated Metacognitive Therapy (IMT). In~     order to measure the efficacy of IMT, all subjects will undergo a battery of assessments in~     each of these domains prior to and following either a novel intervention (N = 10) or~     treatment as usual (N = 10) for a period of approximately six months. Throughout the study,~     each IMT session (N = 10, 24 sessions each) will be audio recorded, transcribed, and~     de-identified to allow for careful ongoing qualitative analyses of potential active and~     inert ingredients of the approach and ultimately the development of an IMT manual which can~     then be tested in a larger, more rigorous randomized control trial. This investigation will~     play an important role in advancing current knowledge about treating insight in early~     psychosis. Further, it will serve to expand upon the intervention tools available by~     producing a much needed treatment manual designed specifically to target insight during an~     illness phase crucial for positive long term outcomes in psychosis.~   "
70764|NCT02131103|"~     1. Objective: To evaluate short- and long-term in the STEMI patients who successfully~          thrombolysis with early routine and delay percutaneous coronary intervention in~          low-intermediate risk patients.~        2. Educational/ application advantages: To evaluate the time of early and delay PCI after~          received fibrinolysis had an effect to the short- and long-term clinical outcomes in~          low- intermediate GRACE risk score patients. No available of randomized controlled~          study in these group of the patients.~   "
70765|NCT02131090|"~     A number of methods are currently used to prevent movement of epidural catheters in women~     during labour. These usually consist of sticky dressings applied to the patient's back. The~     purpose of this study is to compare how much epidural catheters move when secured with three~     commonly used different fixation dressings with the aim of identifying the best method of~     securing epidural catheters.~      Movement of epidural catheters has several clinical implications. Usually only a short~     length of epidural catheter is left in the epidural space, and therefore any significant~     movement could result in the catheter moving out of the epidural space leading to a loss of~     the pain relieving effects of the epidural.~      Once epidural failure has occurred due to catheter migration, a second catheter must be~     inserted in order to re-establish pain relief and thus the patient is exposed to the risks~     of epidural insertion for a second time.~      If the researchers in this study can identify a method of fixing epidural catheters which~     results in the least amount of catheter movement, then patients could benefit from more~     reliable epidural pain relief, fewer repeated procedures and the risks associated with~     repeated procedures.~      The principle objective of the study is to determine which epidural fixation dressing~     results in the least amount of epidural catheter movement from the time of epidural~     insertion (during labour) to the time of epidural removal (after labour).~   "
70767|NCT02131064|"~     In this randomized, multicenter, open-label, two-arm study, Kadcyla (trastuzumab emtansine)~     plus Perjeta (pertuzumab) will be compared to chemotherapy plus Herceptin (trastuzumab) plus~     Perjeta in the treatment of operable HER2-positive breast cancer. Patients will be~     randomized in a 1: 1 ratio to receive either of the following neoadjuvant treatments for a~     total of six 3-week cycles:~      Arm A: Docetaxel + carboplatin + Herceptin + Perjeta Arm B: Kadcyla + Perjeta~      Following treatment, patients will undergo surgery. After recovery, patients will be given~     the following adjuvant treatment:~      Arm A: Herceptin + Perjeta Arm B: Kadcyla + Perjeta Treatment can be stopped due to disease~     recurrence, unacceptable toxicity, withdrawal of consent, or study termination. Study is~     expected to last approximately 45 months.~   "
70768|NCT02131051|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops.~     In addition the effectiveness and safety shall be compared to Azelastine containing nasal~     Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes~     Azelastine nasals spray and eye drops according to the instructions for use. The observation~     takes place over a period of 7 days. Response to treatment is recorded at day 7 by the~     physician and in daily by the patient in a dairy.~   "
70769|NCT02131038|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition~     the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray.~     The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray~     according to the instructions for use. The observation takes place over a period of 14 days.~     Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in~     a dairy at defined time intervalls.~   "
70770|NCT02131012|"~     Intraocular delivery of celecoxib will be an effective means to treat inflammation and~     macular edema and prevent structural complications and vision loss in patients with chronic~     inflammation or macular edema who are unable to tolerate corticosteroids due to their side~     effects.~   "
70771|NCT02130999|"~     Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24).~     Non-24 is very common in people who are totally blind because light can not reset their body~     clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour~     day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes~     nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming~     urge to nap.~      Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and~     intravenously (I.V.) by infusion through a catheter (not an injection) into a vein. The oral~     administration is approved by the FDA. The I.V. administration is considered investigational~     as it has not been approved by the FDA. This will be the first time tasimelteon will be~     given to humans by intravenous (I.V.) injection.~      The purposes of this research study are to:~        -  assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;~        -  evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose~          and after a single 2 mg I.V. dose;~        -  evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20~          mg oral dose and after a single 2 mg I.V. dose;~        -  evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and~        -  evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.~      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and~     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood~     samples will be taken throughout the study for PK analysis.~   "
70772|NCT02130986|"~     The ProACT study is a 5 year, multicenter study that will test the effect of implementation~     of a novel procalcitonin guideline on antibiotic use and adverse outcomes in emergency~     department (ED) patients with lower respiratory tract infection (LRTI).~   "
70773|NCT02130973|"~     This is a three-year study to evaluate the effect of sequential therapy of Forteo~     (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.~   "
70774|NCT02130960|"~     This research is being conducted to study the reliability of a method used to measure~     resting metabolic rate, or how much energy a person expends while at rest.~   "
70775|NCT02130947|"~     This randomized pilot study will be conducted in men with metastatic castration resistant~     prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The~     purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in~     mCRPC patients who have recently started on additional androgen suppression therapy.~   "
70776|NCT02130934|"~     This is a non-randomized prospective pilot study in a single academic center with historic~     controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who~     have undergone childhood cancer treatment that has cardio-toxic effects to historic~     controls. The ultimate goal of this study is to develop a safe and effective method for~     early diagnosis of heart problems in children who are receiving chemotherapy treatments that~     may be toxic to the heart.~   "
70777|NCT02130921|"~     This proposed study is an initiative for HIV prevention and care that integrates~     intervention efforts at multiple strata: Community Health Workers (CHWs), Injecting Drug~     Users (IDUs), and their Family Members (FMs). The proposed study will demonstrate the~     process of development, implementation, and evaluation of an intervention for CHWs, IDUs,~     and their FMs. One aim is to increase the CHWs' capacities to effectively interact with IDUs~     and FMs for HIV and drug use prevention and treatment. Using a combination of participatory~     action research and a randomized controlled trial design, this study has the potential to~     maximize PEPFAR impact in Vietnam and other PEPFAR-funded countries by identifying a~     sustainable mix of interventions and their implementation in different settings. The~     findings may benefit not only Vietnam but also a global audience by investigating enhanced~     methods for controlling the HIV epidemic.~   "
70778|NCT02130908|"~     This study is a pilot study to investigate whether intake of lean or fatty fish, or lean~     meat would affect parameters related to health in healthy non-obese adults, and will serve~     as basis for future calculation of group sizes in coming studies. Participants consumed~     750g/week of fillets of fish or meat for 4 weeks.~      Hypothesis:~      High intake of either lean or fatty fish will not affect serum concentrations of lipids and~     inflammatory markers as well as improve glucose tolerance during the 4 week intervention~     period when compared to lean meat intake.~   "
70779|NCT02130895|"~     This mixed methods study seeks to assess and understand the impact of using an advanced CDS~     tool to present the STOPP criteria to support prescribers at the point of decision-making.~     We ask the overarching question:~      **How can clinical decision support tools effectively translate a complex set of~     evidence-based rules into primary care clinical practice?**~      The work is divided into 2 phases.~      PHASE 1: Randomized control trial. We will measure change in potentially inappropriate~     prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical~     Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those~     who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the~     same criteria that will be used in the clinical decision support tool in the EMR. We will~     use the OSCAR EMR for this study. EMR based queries will be developed to assess the number~     of potentially inappropriate prescriptions are current in each of 12 physician practices at~     baseline and at 16 weeks.~      PHASE 2: We will then complete a qualitative follow up with participants to aid in~     understanding how primary care prescribers perceived the CDS. This will help explain Phase 1~     findings and provide additional information to enhance future decision support tools.~   "
70780|NCT02130882|"~     Background:~      - Eosinophils are white blood cells that help fight infections. High eosinophil levels can~     damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study~     if the drug benralizumab can help people with HES.~      Objective:~      - To test if benralizumab can safely decrease eosinophils in people with HES.~      Eligibility:~      - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have~     symptoms and high eosinophil levels.~      Design:~        -  Participants will be screened with medical history, physical exam, and urine and blood~          tests. They will take simple heart and lung tests.~        -  Participants will also have a bone marrow biopsy. A numbing medicine is injected into~          the outer covering of the bone. Then a needle is inserted into the bone. A fast suction~          movement takes bone marrow cells.~        -  Phase 1: Participants will randomly receive either the study drug or placebo as an~          injection.~        -  They will have daily visits for the next 3 days, then 4 weekly visits, and then 4~          biweekly visits. Each time, they will have medical history, physical exam, blood tests,~          and a check of side effects.~        -  They will receive another dose of the study drug or placebo at 1 month and 2 months~          after the first injection.~        -  Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.~        -  At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the~          heart and lung tests. They will also have one other bone marrow biopsy.~        -  After week 24, participants will receive the study drug either 6 times over 6 months or~          twice over 6 months.~   "
70781|NCT02130869|"~     This is a pilot clinical trial investigating the addition of haploidentical natural killer~     cell infusion to autologous stem cell transplantation. This intervention will be evaluated~     in children with high-risk solid tumors for whom autologous transplantation is indicated.~     Natural killer cells from a haploidentical family member will be given after high dose~     chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma,~     the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic~     cell recovery will be evaluated and survival of children treated with this approach will be~     determined.~      The investigators expect to enroll 36 participants. Haploidentical family members (donors)~     will also be recruited to provide natural killer cells.~   "
70782|NCT02130856|"~     There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are~     due to infection, low birth weight (LBW), and prematurity. Low tech but high impact~     interventions and commodities used in unconventional ways could save hundreds of thousands~     of newborn lives. We propose an integrated evidence-based toolkit usable by community health~     workers (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied~     to the umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to~     identify hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.~   "
70783|NCT02130843|"~     A report of a technique for insertion a soft urodynamic catheter into the bladder, when~     urethral obstruction causes the catheter to bend and fold over itself at the resistance~     site.~   "
70784|NCT02130830|"~     Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal~     disease. However, 90% of patients have some degree of discomfort associated with the~     procedure and up to 40% develop clinically significant pain. Some studies have used local~     anesthesia to reduce pain with promising results, but the use of topical anesthesia has not~     been reported before.~      The investigators hypothesize that the use of topical anesthesia before rubber band ligation~     significantly reduces post procedure pain.~   "
70785|NCT02130817|"~     The purpose of this study is to evaluate the safety and effectiveness of an~     immunosuppressive medication, Belatacept, as a replacement for a calcineurin inhibitor, in~     combination with a standard of care regimen of immunosuppressive medications and plasma~     exchange (plasmapheresis and immunoglobulin treatment) for kidney transplant patients who~     are moderately sensitized against their deceased donor and at-risk for delayed graft~     function. The hypothesis is that moderately sensitized patients who receive Belatacept~     treatment with the standard of care regimen will lead to lower acute rejection rates than~     historical controls based on assessment of standard of care biopsies and standard Banff~     criteria.~   "
70793|NCT02130713|"~     Background - bacterial prostatitis (BP) is a common condition accounting responsible for~     about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type~     II, are less common but is a condition that significantly hampers the quality of life, (QoL)~     because not only is it a physical condition but also a psychological distress. Commonly~     patients are treated with antibiotics alone, and in particular fluoroquinolones are~     suggested by the European Urology guidelines. This approach, although recommended, may not~     be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.~      Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study.~     All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The~     purpose of the study was to evaluate the efficacy of a long lasting therapy with a~     fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21~     days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin~     100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively~     antibiotic alone and an association of antibiotic plus supplement.~   "
70786|NCT02130804|"~     Background: The prevalence of obesity has increased throughout the last three decades due to~     genetic, metabolic, behavioral, and environmental factors. Obesity and high-fat western~     diets activate inflammatory processes, which promote development of insulin resistance as~     well as other metabolic complications. Increasing obesity rates are a major public health~     concern in the Hispanic population due to the large number of Hispanics suffering from~     obesity. Based on preliminary data, we propose a double-blind randomized clinical trial of~     Salsalate therapy in obese Hispanic young adults. Salsalate treatment shows promise for~     decreasing inflammation under conditions of weight stability by reducing macrophage~     infiltration of adipocytes. Hispanics have the greatest amount of visceral adipose tissue~     (VAT), liver fat, and inflammation when compared to other ethnic groups, thereby increasing~     the potential for treatment effects in this high-risk population.~      Purpose: The purpose of this study is to demonstrate through a proof-of-concept trial that~     Salsalate induced reductions in adipose tissue inflammation are possible under conditions of~     weight stability.~      Methodology: We will recruit obese Hispanic young adults (18 - 35 years) from hospitals,~     clinics, and community centers. Study Endpoints: Primary outcomes will be macrophage~     infiltration as assessed by the presence of crown-like structures (CLS) in subcutaneous~     adipose tissue (SAT) biopsies, liver fat, insulin sensitivity, and fasting glucose. We will~     also assess plasma levels of monocyte chemoattractant protein (MCP)-1, tumor necrosis factor~     (TNF)-α, interleukin (IL)-1, C-reactive protein (CRP), and SAT gene expression of nuclear~     factor kB (NF-kB) and insulin signaling pathways.~      Intervention and Follow-up: Participants will be randomly assigned to four weeks of~     treatment with Salsalate (4 g/d) or placebo and will be studied under weight maintenance~     conditions. These measures will enable us to determine if Salsalate treatment is capable of~     reducing adipose tissue inflammation and related metabolic outcomes in the absence of weight~     loss.~   "
70787|NCT02130791|"~     Insufficient sleep is common, affecting 20-40% of adults, and resulting from sleep~     disorders, medical conditions, work demands, stress/emotional distress, and social/domestic~     responsibilities. It produces significant social, financial and health-related costs, and it~     has increasingly become a major public health concern as population studies worldwide have~     found that reduced sleep duration is associated with increased risks of obesity, morbidity,~     and mortality. It is well established that sleep loss causes fatigue and sleepiness, as well~     as errors and accidents that are due to its adverse neurobehavioral effects on alertness,~     mood, and cognitive functions. However, there are substantial, trait-like differences among~     people in the extent to which they experience such neurobehavioral deficits when sleep~     deprived. Common genetic variations involved in sleep-wake, circadian, and cognitive~     regulation may underlie these large inter-individual differences in neurobehavioral~     vulnerability to sleep deprivation, though it remains unclear whether different types of~     sleep deprivation involve the same phenotypic responses and same genotypic contributors.~     This project will be the first large-scale investigation of markers of differential~     cognitive vulnerability to both acute total sleep loss and chronic partial sleep loss. It~     will identify individuals who are at significant risk for fatigue and severe impairments~     from sleep loss. A total of 110 healthy adults will undergo a 13-day laboratory protocol to~     thoroughly characterize their cognitive, psychological and physiological responses to two of~     the most common forms of sleep loss--acute total sleep deprivation (1 night of sleep loss)~     and chronic partial sleep deprivation (5 nights of sleep limited to 4 hr). The findings from~     this study will represent a critical first step toward tailoring appropriate follow-up~     interventions for sleep loss and its symptomatic relief by finding predictors of at-risk~     individuals who should avoid sleep loss whenever possible, and/or seek effective~     countermeasures. Whether or not markers of neurobehavioral vulnerability to sleep loss are~     identified, the results of the project will help inform public policies pertaining to the~     need for adequate sleep and for countermeasures for sleep loss, and also will further our~     understanding and management of vulnerability to excessive sleepiness due to common sleep~     and medical disorders.~   "
70788|NCT02130778|"~     Adipose and diabetic patients have glomerular hyperfiltration and enhanced reabsorption of~     sodium in the kidney leading to fluid retention and hypertension. It is already known that~     obese mice (db/db) have salt retention and elevated intrarenal angiotensin II , and that the~     mechanism of the salt retention is similar to the one described in human beings. In~     experimental study from 2009 done by Hirata K and al., published in Biochemical and~     Biophysical Research Communications to both obese type 2 diabetic db/db mice and~     non-diabetic db/m mice hypertension was artificially induced (acute sodium-loading and~     angiotensin II-infusion). Two groups of mice were treated with exendin-4 or vehicle for 12~     weeks. Obese type 2 diabetic db/db mice show high salt-sensitivity. Exendin-4 demonstrated~     anti-hypertensive effect in db/db mice and angiotensin II-infused mice, related to~     attenuation of high salt-sensitivity. That observation confirmed that exendin-4, a GLP-1~     (Glucagon-like peptide-1) analogue, has extra-islet effect including the regulation of salt~     handling. More then ten years before mentioned observations the presence of GLP 1 receptors~     was confirmed all over the body, also in kidneys. In 2004 Gutzwiller published a study in~     Journal of Clinical Endocrinology and Metabolism that examined 15 healthy subjects and 16~     obese men (mean body mass index, 36 kg/m2) in a double-blind, placebo-controlled, crossover~     study. After overnight fasting hypertonic saline was infuse followed by 3-h infusion of~     GLP-1. Intravenous infusions of GLP-1 enhanced sodium excretion, reduced H+ secretion, and~     reduced glomerular hyperfiltration in obese men. These findings suggest an action at the~     proximal renal tubule and a potential renoprotective effect. Two years later same author~     with colleagues published a new study in Digestion. In a part of new study he observed 8~     volunteers. The protocol included intravenous salt load compared to the effect of an~     infusion of GLP-to isotonic saline (placebo). Extracellular volume expansion induced by an~     intravenous infusion of hypertonic saline was partially compensated by an increase in~     urinary sodium and water excretion with GLP-1. He explained that volume expansion was~     associated with increased renal perfusion, rise in glomerular filtration and the filtered~     sodium load. It was observed that GLP-1 is able to increase renal sodium excretion by 69%~     and urine volume by 86%. Considering all mentioned above it is obvious that GLP-1 have~     natriuretic effect, although its exact mechanism and clinical usefulness remain unclear.~     Both GLP1 analogues and inhibitors of DPP4 (dipeptidyl peptidase 4), elevate GLP1 level, and~     it would not be a surprise to observe similar natriuretic effects in the body. Since GLP 1~     is a peptide given IV. or sc. there are on long-term studies that observe final possible~     effect no blood pressure, but GLP1 analogues and DPP4 inhibitors enhancing the incretin~     action demonstrate some antihypertensive properties. 2008 in a study done by Mistry GC and~     al., published in Journal of Clinical Pharmacology antihypertensive effect of sitagliptin~     was observed. In nineteen patients on stable treatment with antihypertensive agent(s)~     investigators found small but statistically significant reductions of 24-hour ambulatory~     blood pressure. There are no many definitive clues why the blood pressure should droop~     during any treatment that elevates serum GLP1. At the end of 2009 an analysis was published~     in American Journal of Hypertension, showing results from six trials including 2,171~     subjects treated with exenatide for at least 6. Again, a significantly greater reduction in~     systolic blood pressure was confirmed, not giving an explanation why it happened so.~     Finally, Prof. Sjöholm from Karolinska institute Sweden published in Diabetes, obesity and~     metabolism a review concerning impact of GLP-1 on endothelial function. He mentioned again~     decreased blood pressure through improvements in diuresis and natriuresis, but he also added~     a new element, improved endothelial dysfunction through GLP-1 receptor-dependent pathway.~     Though there are many speculations, exact antihypertensive effects and water homeostasis of~     both GLP-1 itself, also of GLP1 analogues and DPP4 inhibitors is still unknown. Finally,~     recent review (Tanaka et all) from 2011 confirms mentioned speculations regarding~     natriuretic effect of GLP1, quote … Incretin mimetics and DPP-IV inhibitors are a novel~     class of antihypertensive drugs with natriuretic properties. They can be used in the~     treatment of salt-sensitive hypertension, which is characterized by edema. The idea is to~     investigate the effect of GLP1 on diuresis/natriuresis compared with placebo in healthy~     non-obese people and to compare natriuresis with GLP-1, BNP (brain natriuretic peptide) and~     ADH (antidiuretic hormone) levels in serum.~   "
70789|NCT02130765|"~     To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™~     ablation catheter system results in a superior clinical outcome compared to routine drug~     therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both~     ischemic and non-ischemic) while maintaining an acceptable safety profile.~   "
70790|NCT02130752|"~     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of~     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons~     all over the world. By the invented and adopted energy surgical instruments, surgical~     procedure is safer and easier than before. The newly surgical instruments reduce the~     post-operative mortality and morbidity combined easy procedures of surgery. As the most~     popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar~     electrocautery were received lots of attention and concern. Some studies have shown some~     advantage of the two instruments, which were they can facilitate the surgical treatment and~     make the surgery safer and more effective. Although, some small retrospective sample reports~     claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node~     intraoperative complications and even postoperative complications. And Korea small sample~     randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and~     surgical duration. However, postoperative complications were with no statistical~     significance between the two instruments. Cost- effective analysis of the energy instruments~     is still controversial. Large sample randomized control trail with high quality is needed.~      By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals~     from North to South in China aims to compare the clinical characteristics and outcomes, when~     using of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy.~     The aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with~     monopolar electrocautery in D2 distal gastrectomy, include, intraoperative parameters,~     postoperative complications, cost data, and post-operative quality of life.~   "
70791|NCT02130739|"~     This study prospectively evaluates the incidence of Horner's syndrome after thoracic~     epidural anesthesia following continuous thoracic epidural analgesia for mastectomy. The~     incidence was 1.36% and the mechanism of Horner's syndrome was cephalic spread of the local~     anesthetic.~   "
70792|NCT02130726|"~     Laparoscopic surgery has been shown to provide important advantages in comparison with open~     procedures in the treatment of several malignant diseases, such as less peri-operative blood~     loss, faster patient recovery and shorter hospital stay. All while maintaining similar~     results with regard to tumour resection margin and oncological survival. In gastric cancer~     the role of laparoscopic surgery remains unclear.~      Current recommended treatment for gastric cancer consists of radical resection of the~     stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker~     for radicality of surgery and quality of care. Therefore, It is imperative that a new~     surgical technique should be non-inferior with regard to radicality and lymph node yield.~      Preliminary studies show promising results for laparoscopic gastrectomy, but the number of~     studies is small and due to lower incidence of gastric cancer in the West they are often~     underpowered. A prospective randomised clinical trial is indicated in order to establish the~     optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.~      Results of the STOMACH trial will further aid in determining the optimal surgical technique~     in patients with gastric cancer.~   "
70794|NCT02130700|"~     The goal of this clinical study is to determine the safety and efficacy of VT-464, a~     lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer~     (CRPC) who have been previously treated with enzalutamide.~   "
70796|NCT02130674|"~     Severe traumatic brain injury is associated with life-threatening and incapacitating~     secondary injury.~      Contemporary therapeutic interventions are aimed at preventing and treating secondary~     damage. In this context, improved cerebral metabolism is an important target in modern~     neurointensive care.~      The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide~     restores disturbed brain metabolism following severe traumatic brain injury.~   "
70797|NCT02130661|"~     Rilapladib is a potent and selective inhibitor of lipoprotein associated phospholipase A2~     (Lp-PLA2), which was previously under development for the treatment of atherosclerosis and~     is currently being developed for the treatment of Alzheimer's disease.~      This study is a single-center, open-label, two-part study. The two study parts will run~     independently. Subjects dosed in one part of this study will not be permitted to participate~     in the other part.~      Part A will investigate the pharmacokinetic profile of rilapladib and its metabolites,~     SB-664601 and GSK1174379, after single dose and steady state dosing of rilapladib 250~     milligram (mg) along with the biliary and urinary elimination pathways of rilapladib 250 mg.~     Part B will determine the effect of repeat administration of itraconazole on the PK of a~     single oral dose of rilapladib 25 mg.~      Healthy male and female subjects, aged 18-65 years, will be recruited for this study. Ten~     subjects will be recruited for Part A and 20 subjects will be recruited for Part B.~   "
70798|NCT02130648|"~     The purprose of this study is to develop and validate an analytical and clinical NIPD test~     for cystic fibrosis from maternal blood by analysis circulating free fetal DNA (cff-DNA),~     searching for the paternal mutation in families with CFTR compound heterozygosity~   "
70799|NCT02130635|"~     This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the~     safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557~     administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will~     also be assessed. This study will have two parts. In Part A, subjects will be randomized to~     active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses~     of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female~     of non-child bearing potential) will be screened to ensure that approximately 30 subjects~     are enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35~     subjects will be enrolled for Part B. In both the parts, subjects will receive study~     treatment once daily for 14 consecutive days. Placebo control will be included for a valid~     evaluation of adverse events attributable to treatment versus those independent of~     treatment.~   "
70800|NCT02130622|"~     Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed~     gastric emptying will be recruited to participate in the study. Using double-blinded~     methodology, study participants will be randomly assigned to one of two treatment arms:~     promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days.~     The primary outcome will be the change in gastroparesis symptom severity, as measured by the~     Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants~     will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores,~     adverse events and treatment compliance will be assessed. It is hypothesized promethazine~     treatment will be superior to placebo in improving symptoms of gastroparesis.~   "
70801|NCT02130609|"~     The objective of this study is to improve the treatment guidelines for the Elite+ by~     determining the maximum safe settings for skin and correlate them to measurement of Melanin~     Index (MI) (MI).~   "
70802|NCT02130596|"~     Obesity occurs at 2-3 times the general population rate in persons living with a psychotic~     illness. The risk of obesity-related serious medical conditions like diabetes and heart~     disease are also two to three times higher in this population. Traditional behavioral weight~     management approaches help more than half of these individuals to lose weight, but a~     significant proportion are not helped. This pilot study is intended to determine the~     feasibility, efficacy, acceptability, and potential clinical utility of an intervention that~     integrates mindfulness, acceptance, distress tolerance, and motivation and commitment~     combined with traditional behavioral strategies for weight loss. This is the first study to~     investigate such an acceptance-based behavioral intervention for weight loss in psychotic~     illness. The results from this study will help to determine whether future research in this~     area is warranted with a larger sample, over a longer period of time.~      Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance~     based behavioral intervention, relative to those who receive nutritional counseling.~   "
70803|NCT02130583|"~     The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a~     significant public health concern. The investigators propose a new treatment approach in~     which skills to increase positive emotions are taught to the most vulnerable at-risk~     adolescents, those admitted to an inpatient psychiatric unit due to suicide risk. The~     investigators believe that teaching skills to increase positive emotions will lead to better~     problem-solving, increased social support, and other benefits which will serve as protective~     factors and decrease suicide risk.~   "
70804|NCT02130570|"~     The objective of this study is to design and implement a set of procedures (the~     intervention) to improve patients' experiences when they are discharged home from the~     hospital. Second, this study aims to look at how the intervention affects problems that are~     known to occur after discharge, including medication issues, worsening medical problems, or~     readmission to the hospital. The investigators will study how well patients recover the~     ability to do the things they could before they were admitted to the hospital and their~     opinions of the discharge process. Lastly, this study will look to understand the best way~     to implement the intervention into different hospitals and practices, and which types of~     patients benefit from it most.~   "
70805|NCT02130557|"~     Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive~     bosutinib or imatinib for the duration of the study.~   "
70806|NCT02130544|"~     Viedo-assisted thoracoscopic surgery(VATS) have became popular in recent years. There is no~     golden rule of postoperative analgesia for VATS. Compared with lobectomy, wedge resection~     preserves better pulmonary function and is suitable for elder patients and patients who~     could not afford to have lobectomy. In addition to surgery time、recovery time and hospital~     stay, wound incisions and organization damages are different,too. Will patients also have~     different response to pain control after these two surgery? The retrospective study is to~     compared the differences of postoperative pain management between VATS lobectomy and wedge~     resection.~   "
70808|NCT02130518|"~     Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract~     infections and blockage caused by crystalline biofilm accumulation (encrustation) of the~     catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria~     such as Proteus mirabilis, encrustation of the catheter is likely to occur.~      The use of a catheter irrigation solution that can prevent biofilm formation and~     encrustation leading to blockage may keep the catheter patent longer, resulting in fewer~     catheter changes, potentially lower incidence of UTIs and better patient quality of life.~      Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits~     potential for the rapid decolonization of a range of urologic pathogens, including the~     urease-producing Proteus mirabilis.~      Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle~     solution.~   "
70809|NCT02130505|"~     In this study, we will investigate both inflammatory systems in healthy volunteers and~     patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH)~     and familial combined hyperlipidemia (FCH)) during an OGTT.~   "
70810|NCT02130492|"~     The objectives of this Pilot study are to investigate the toxicity and safety of high doses~     of [18F]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced~     stage IV malignant tumors that failed standard of care treatment, have a good performance~     status and bear radiosensitive tumors with a high [18F]-FDG uptake.~      The investigators hypothesize that [18F]FDG may have a significant tumoricidal effect on~     cancer cells and radionuclide therapy of cancers with high doses of [18F]FDG administered as~     a single dose or in multiple doses (dose fractionation regimen) can be safe and well~     tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human~     tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely~     with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent~     for treatement is that most malignant lesions have accentuated glucose metabolism, which is~     mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like~     glucose, it is effectively confined within the cancer cells; thus, FDG treatment is~     potentially a novel form of targeted therapy for tumors with increased FDG uptake.~   "
70811|NCT02130479|"~     This study aims to address a serious public health problem (i.e., substance abusing~     adolescents) by testing the effectiveness of a promising substance abuse treatment~     implemented in a community-based treatment setting (CM-FAM, a family-based contingency~     management intervention) in comparison to usual treatment services.~   "
70812|NCT02130466|"~     This is a 5-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) +~     dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are~     open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose~     (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is~     sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study~     of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the~     Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Part 4 is~     nonrandomized and open-label and is designed to evaluate the safety and tolerability and~     identify the MTD or MAD of Pembro+T in participants who have v-raf murine sarcoma viral~     oncogene homolog B1 [BRAF] mutation-negative (without V600 E or K) melanoma or solid tumors~     [irrespective of BRAF status]. The primary hypothesis (Part 4) is that Pembro+T is~     sufficiently well-tolerated to permit clinical investigation. Part 5 will confirm the~     dose(s) identified in Part 4 in participants BRAF wild type [without V600E or K] melanoma or~     solid tumors [irrespective of BRAF status] and will further evaluate the safety and~     preliminary efficacy (Objective Response Rate [ORR]) of Pembro+T in participants who have~     BRAF wild type [without V600E or K] melanoma only. The primary hypotheses (Part 5) are that~     Pembro+T is sufficiently well-tolerated at the MTD/MAD to permit further clinical~     investigation and is effective in attaining objective responses based upon Response~     Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator review in~     participants who have melanoma without BRAF V600 E or K mutations.~      Parts 1 and 2 of the study will also explore the MTD/MAD for open-label Pembro+T (for BRAF~     mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF~     mutation-positive participants).~   "
70813|NCT02130453|"~     The goal of this clinical research study is to compare regadenoson nuclear stress testing~     with echocardiography strain measurements (an ultrasound imaging method that measures hearts~     function) in detecting coronary artery disease.~   "
70814|NCT02130440|"~     The aim of this study is to evaluate whether treatment with a nasal spray based on~     resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or~     severe.~   "
70815|NCT02130427|"~     This pilot study will determine changes over time in tumor volume/motion & patient anatomy,~     as well as dose distributions to normal organs. The study will inform medical~     decision-making about need for (and timing of) re-calibration of radiation dosimetry plans.~     Weekly CT and/or serial MR scans will be employed for those patients receiving 7-8 wks of~     radiation therapy. The study will enroll 30 patients in each stratum: Non small cell lung~     cancer (NSCLC), Head & Neck, gastrointestinal (GI) and Gynecologic tumor.~   "
70816|NCT02130414|"~     The aim of this Phase I, single centre, multi stage study is to evaluate the safety,~     tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine~     capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.~   "
70817|NCT02130401|"~     This is a pilot study with a single active treatment arm. The study is designed to assess~     the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2~     Diabetes. In particular, the primary outcome measure is a reduction in A1c.~   "
70818|NCT02130388|"~     Sepsis is the body's response to a life-threatening infection. This study will determine if~     zinc supplementation is safe to use in patients with severe sepsis or septic shock. This~     study will also gather preliminary information to evaluate the impact that zinc has on the~     immune system (the body's defense system against infection) and whether zinc can help~     monocytes and macrophages (specific types of cells that remove infections from the body)~     work more effectively.~   "
70819|NCT02130375|"~     The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on~     urinary symptoms and female sexual function.~   "
70820|NCT02130362|"~     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in~     pediatric patients with moderately to severely active CD who are treated as recommended in~     the local product label.~   "
70864|NCT02129790|"~     Children and adolescents with early-onset bipolar disorder (BD) are at high risk for~     intentionally hurting themselves. Although there are therapies in existence for these youths~     with BD, they do not address suicide prevention specifically. Mentalization-based therapy~     for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent~     and adult population with borderline personality disorder. The investigators will modify the~     MBT-A treatment procedures for persons with BD who have had a recent period of suicidal~     ideation or behavior.~   "
70865|NCT02129777|"~     The purpose of this study is to establish proof of efficacy of namilumab in moderate to~     severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response~     rate at week 12.~   "
70821|NCT02130349|"~     The IBD South Limburg (IBDSL) project was initially designed as a prospective population~     based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and~     prospectively followed. As from 2011, the cohort is being scaled up into a population based~     biobank and focus expanded from epidemiology towards exploring underlying biologic~     mechanisms and identifying markers to predict disease course or therapy response.~      Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The~     Netherlands), is eligible to participate. The population based nature was reached via a~     multi-faceted approach; incident cases were prospectively identified through the~     participating hospitals, and missed patients were retrospectively identified using the~     nationwide histopathology registry. In 2011, over 3500 patients were included, which~     represents 93% of the IBD population in South Limburg.~      The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra~     intestinal manifestations, medication, surgery, comorbidity and demographics. Data has~     prospectively been updated through chart review (clinical data), questionnaires (i.e.~     quality of life) and linkage to the authority database (vital state, residence). The biobank~     includes serum, plasma, DNA, faeces, biopsies and exhaled air.~      We welcome new collaborations. Applications for collaboration are first to be approved by~     our IBD-SL committee.~   "
70822|NCT02130336|"~     Background. The prevalence of metabolic syndrome (MetS) has been increasing, and its risk is~     positively correlated with age. Due to ageing society in Taiwan, how to treat metabolic~     syndrome and decrease the complications is an important health issue. Relatively few studies~     have been focusing on the effects of exercise training in patients with MetS with long-term~     follow-up. Recently, high-intensity interval training or aerobic interval training (AIT)~     consisting of high intensity separated by active recovery has been proposed to be more~     effective than isocaloric continuous moderate-intensity exercise (CME) in raising exercise~     capacity (VO2max) in some specific patient population.~      Purpose. The purposes are to (1) compare the effects of 16-week CME and AIT on reducing the~     numbers of metabolic risk factors in patients with MetS and the prevalence.~      Hypothesis: 16-week AIT reduces more metabolic risk factors than CME in patients with MetS.~      Methods. This study will be a multiple-center trial. One hundred and twenty patients, aged~     ≥45 years, with a diagnosis of MetS for each center will be recruited. Subjects will be~     randomly assigned to either control, CME, or AIT group after baseline assessments.~     Participants in control group will receive usual care and the others in two exercise groups~     will undergo 16-week exercise training. All subjects will receive 16-week, 6-month and~     1-year follow-ups including blood test, body composition (body mass index, waist~     circumference), pulse wave velocity, and maximal exercise testing. Statistical analysis will~     be conducted using SPSS 11.5, p < 0.05 indicating statistical significance. Data will be~     presented in mean±standard deviation or number (percentile) with intention-to-treat~     analysis. Chi-square test or one-way Analysis of Variance (ANOVA) will be used to compare~     whether there are between-group differences at baseline. Two-way repeated measures ANOVA and~     post-hoc test will be performed to examine time and group effect if there is interaction~     effect, otherwise Bonferroni will be used. The subgroup analysis between MetS and n-MetS~     after training will be performed using the same statistical methods.~   "
70823|NCT02130323|"~     OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to~     3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop~     electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has~     been recognized that these procedures can increase the risks for pre-term labor in women who~     still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a~     topical immune response modulator, has significant effects on histological regression of CIN~     2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may~     be preferable offering similar outcomes on histological regression when compared with~     excision or ablation while potentially avoiding or reducing the number of surgical procedure~     that places them at risk for future pregnancies.~   "
70824|NCT02130310|"~     The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to~     Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based~     therapy, containing activated homologous white blood cells prepared from donated healthy~     whole blood. A total of 252 patients will be randomized to receive either CureXcell® or~     Placebo.~   "
70825|NCT02130297|"~     The purpose of this study is to evaluate the potential benefits of treating a surgical scar~     post excision with an ablative fractionated CO2 laser with the goal of decreasing the~     appearance and size of the scar.~   "
70826|NCT02130284|"~     This study is a multi-center, single arm and in-clinic study to evaluate the safety of the~     PLGM System and its algorithm with the Enlite 3 Sensor.~   "
70827|NCT02130271|"~     The purpose of this study is to see if the spine shows areas of inflammation using a~     specific type of imaging (pictures).~   "
70828|NCT02130258|"~     The investigators hypothesize that there may exist different quantitative sensory profiles~     between radicular pain patients who respond and those who do not respond to the standard~     therapy of epidural steroid injections (ESI).~   "
70829|NCT02130245|"~     The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The~     hypothesis is that to do it as an early intervention after patient admission is better than~     delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness~     of the operative maneuver reflected by operative time, conversion and intraoperative~     complications.~   "
70830|NCT02130232|"~     The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy~     diet and physical activity for helping overweight/obese pregnant women to achieve~     appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The~     goal of the intervention is to help women achieve the lower bound of the GWG range~     recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e.,~     11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be~     delivered via 2 in-person counseling sessions and 11 telephone contacts with study~     dieticians trained in motivational interviewing techniques. The lifestyle intervention will~     be compared to usual medical care. Outcomes will be assessed by trained study personnel at~     approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6~     months and 12 months postpartum.~   "
70831|NCT02130219|"~     The aim of the study is to evaluate accuracy and precision of non-invasive intracranial~     pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal~     fluid pressure measured during lumbar puncture~   "
70832|NCT02130206|"~     The purpose of this research study is to investigate the bacterial composition of plaque and~     saliva located in the mouth and associate that with risk factors that cause cavities.~   "
72373|NCT02110043|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement in learning and memory in patients with mild cognitive~     impairment (MCI) and to examine the underlying neuronal mechanism.~   "
70833|NCT02130193|"~     The aim of this First Time in Patient study is to obtain initial information on the safety,~     tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily~     administration of danirixin in subjects with symptomatic chronic obstructive pulmonary~     disease (COPD) having mild to moderate airflow limitation and are at high risk for future~     COPD exacerbations.~      The study will be conducted in two parts. Part A will be a two week open label, single arm~     study in patients with COPD to obtain pharmacokinetic data and safety information of repeat~     dosing of danirixin in the population of interest. Approximately 10 subjects will be~     enrolled in Part A of the study. Progression to and dose selection for Part B will occur~     following review of the data collected in Part A. Part B will be a 52-week, randomized,~     double-blind (sponsor unblind), placebo-controlled on top of standard of care, parallel~     group study. Part B will evaluate several clinical efficacy assessments related to~     exacerbations and respiratory symptoms. Approximately 100 subjects will be enrolled with a~     target of 80 subjects completing 52 weeks of danirixin administration.~   "
70834|NCT02130180|"~     Diabetic ketoacidosis (DKA) is a complication of type 1, or insulin-dependent, diabetes~     (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe~     acidosis. In this state the body breaks down fat tissue for adequate energy production. This~     results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or brain~     swelling, can also occur with severe DKA. Current evaluation for DKA-related CE~     necessitates a high index of clinical suspicion and often times such patients receive~     advanced brain imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound)~     is an alternative imaging technique that can provide immediate diagnostic capability at the~     bedside and minimize radiation exposure. This technique has been used to rapidly and~     accurately detect increased brain swelling through measurement of the optic nerve sheath~     diameter (ONSD) in a number of clinical situations including pediatric head trauma,~     hydrocephalus and ventriculoperitoneal shunt malfunctions, and altitude sickness in adults.~     Investigators plan to conduct a prospective study including children aged 7-18 years. The~     objective of this study is to assess the utility of sonographic measurements of the ONSD as~     a tool for identification of DKA-related CE.~   "
70835|NCT02130167|"~     Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the~     higher risk of high myopia in later life and complications such as retinal detachment and~     maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the~     effect on retarding the myopia progression. Recently the 0.01% atropine was also reported~     effective and with less visual side effects such as mydriasis. The aim of this study is to~     compare the efficacy in controlling myopia progression and visual side effects of 2 low~     concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at~     least -0.5 diopters (D) and astigmatism of -1.50 D or less.~   "
70836|NCT02130154|"~     In this study the investigators aim to investigate whether the sympathetic stimulation of~     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed~     tomography computed tomography scan, differs between young and elderly subjects, as an~     explanation for the diminished metabolic brown adipose tissue activity in the elderly.~      The investigators hypothesis is that sympathetic nervous system activity in the elderly is~     diminished as compared to their younger counterparts as an explanation for the diminished~     metabolic brown adipose tissue activity in the elderly.~   "
70837|NCT02130141|"~     The evidence linking chocolate with lowered blood pressure has been observed. However, the~     interventions have been short, at most 4 weeks. The aim of this study is to find out if the~     habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also,~     more insight to the mechanisms linking chocolate to individual healt-responses is needed.~   "
70838|NCT02130128|"~     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV~     System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious~     lung cancer.~   "
70839|NCT02130115|"~     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV~     System.~   "
70840|NCT02130102|"~     In this research project a module based Ambient Assisted Living solution will be provided to~     elderly living in assisted living homes. Those products and services seek to impact quality~     of life of the elderly and have positive effects on their environment.~   "
70841|NCT02130089|"~     The purpose of this project is to understand if more frequent education of dialysis patients~     (patients with kidney failure who get their blood cleaned and fluid removed by a machine~     instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that~     patients gain between dialysis sessions. Patients who usually gain more fluid than is~     considered ideal will be recruited for this project. Because all patients gain different~     amounts to start, data will be collected for 3 months while the patients receive their usual~     amount of dietitian education. Then the patients will receive intensive (2x/month) education~     on reducing sodium intake from the dietitian and the same data will be collected to see if~     they gain less after the education. After 3 months of intensive education, data will be~     collected for one more month to see if patients keep gaining less or if they go back to~     their old patterns.~   "
70842|NCT02130076|"~     Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events.~     This increased risk is thought to be driven by inflammation-induced endothelial dysfunction,~     an initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve~     endothelial function in patients with RA. Discontinuation of TNFi could therefore worsen~     endothelial function even in the absence of recurrence of systemic inflammation or~     reactivation of arthritis. If stopping TNFi results in worsening of endothelial function~     this would strongly suggest a higher cardiovascular risk in association with TNFi-wthdrawal~   "
70843|NCT02130063|"~     The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to~     iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron~     preparations are ineffective or cannot be used or where there is a clinical need to deliver~     iron rapidly.~   "
70844|NCT02130050|"~     This three-year project aims to~        1. Profile the differentially expressed metabolites in healthy patients with severe~          Obstructive sleep apnea (OSA) before and after six-month continuous positive airway~          pressure (CPAP) treatment~        2. Identify the candidate metabolites involved in biologic pathways attributing to OSA~          phenotyping and response to CPAP treatment~        3. Validate candidate metabolites in the intermittent-hypoxia model of peripheral~          monocytes~   "
70845|NCT02130037|"~     Background: research show that cognitive behavioral therapy (CBT) is effective inreducing~     bulimia nervosa (BN) and binge eating disorder's (BED) symptoms. Today, with the development~     of technology there are efforts being made for developinga treatment to these eating~     disorders threw the media, most of these attempts are based on the CBT method. The size of~     the effect that CBT given threw the internet has on BN and BED is still not entirely clear.~     Research presented today are mostly based on treatments that were given threw email or~     Skypeor an automatic self- help stage program. These researches show heterogenic results~     about the effect it had on eating disorders. In this research we aim to investigate the~     effect size that a CBT treatment threw a smartphone application that combines a clinician~     online reply and an automatic feedback in addition to astandard ones a week clinic treatment~     has on BN and BED symptoms frequency.~      Methods: Our aim is to make a research using an application that treats that offers an~     automatic and human therapist and dietitian reply threw a similar application that is suited~     for them. A selected 40 BN or sub-threshold BN or BED patients, men and women ages 18-60~     ,that will turn to the Sheba eating disorder medical center will include the research.~     Half of the participants will receive aCBT treatment threw a smartphone application along~     with astandardclinical treatment that includes ones a week session with a therapist and ones~     a week session with a dietitian and the other half will receive a standardclinic treatment~     alone. We will test the eating disorder symptoms using eating disorders questionnaires at~     the starting point, at the end of a six months treatment and six months after finishing the~     treatment.~      Importance: This research will allow testing the need and benefit that a personal and direct~     patient- therapist connection has over a standardones a week meeting connection format. In~     addition, treating with a web application in the future might have a benefit of saving time~     spent on getting to the clinic, will allow to shorten the time of the session in the clinic~     and will save cost of the face to face treatment.~   "
70846|NCT02130024|"~     This study will assess the development of Geographic Atrophy with either ranibizumab or~     aflibercept in patients with wet Age related Macular Degeneration.~   "
70847|NCT02130011|"~     This study will prospectively collect patients undergoing the standard CROSS regimen in the~     neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will~     focus on the potential geometric differences between the OAR and target volume on the~     initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They~     expect a potential difference in the abdominal part of the planned target volume (PTV)~     and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling ,~     potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be~     monitored.~   "
70848|NCT02129998|"~     The aim of this study is to achieve a more profound understanding of the endocrine~     alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and~     to explore the optimal progesterone level needed for securing implantation and development~     of early pregnancy.~      The second part of the project will determine the value of Preimplantation Factor (PIF)~     measurement in embryo culture medium as a possible tool for improved embryo selection and~     the use of PIF as an early pregnancy serum marker for healthy implantation and embryo~     development.~      IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.~   "
70849|NCT02129985|"~     Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic~     patients can further improve glycemic control, diabetes remission rate and β-cell function~     after the short-term insulin intensive therapy.~   "
70850|NCT02129972|"~     The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in~     adults as in children. The colonoscopy is considered as the gold standard exam for the~     diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The~     follow-up and financial management of this kind of pathology is very much dependent on the~     quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique~     which assumes a general sedation, many efforts have been done to develop new less expensive~     and less invasive techniques in order to offer alternatives to the classic colon endoscopy.~     One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 -~     Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique~     which has been successfully validated with adults. We hypothesize that the CVC can be used~     in children with similar results in terms of efficacy, as is the case for adults.~      This prospective simple blind multicenter study, will investigate the diagnostic value of~     the CVC compared to the conventional colonoscopy under general sedation for the detection~     and the control of colon lesions in children presenting IBD.~      If the feasibility and the efficacy of the colon video capsule technique are also proven for~     use with children, then this new technique might become a very interesting alternative for~     the endoscopic examination of the colon because of being less expensive and less invasive.~      Moreover, this technique would be very useful as a means of lesions detection all along the~     digestive tract and not limited to the colon only.~   "
70851|NCT02129959|"~     The aim of this study is to observe the cardiovascular effects of the degree of head-down~     angle and pneumoperitoneum during laparoscopic procedure using by the fourth version~     Vigileo-Flotrac system.~   "
70852|NCT02129946|"~     The purpose of this study is to determine if consumption of bagels made with resistant~     starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in~     adults.~   "
70853|NCT02129933|"~     To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of~     patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there~     is a need for better endoscopic visualization and the ability for targeted biopsies. Optical~     molecular imaging of neoplasia associated biomarkers could form a promising technique to~     accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor~     (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal~     tissue and has proven to be a valid target for molecular imaging. The University Medical~     Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting~     humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the~     fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered,~     it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma~     (EAC), enabling early cancer visualization using a newly developed fluorescent NIR~     fiber-bundle. This hypothesis will be tested in this pilot intervention study.~   "
70866|NCT02129764|"~     Hyperuricemia is a very common finding in patients with heart failure. It is usually related~     to diuretic use and deteriorated renal function. The recently evidence showed that~     prednisone and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic~     heart failure patients with hyperuricemia, but prednisone may be superior over allopurinol~     in renal function improvement. Thus the investigators design this randomized head to head~     study to test their hypothesis that prednisone is superior over allopurinol in renal~     function improvement despite their similar effect on UA lowering in heart failure patients~     with hyperuricemia.~   "
70867|NCT02129751|"~     Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety~   "
70854|NCT02129920|"~     Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common,~     reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable~     to provide early anticoagulation for cardioembolic stroke. However, early anticoagulation~     may increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to~     decide the timing of initiation for anticoagulant therapy in stroke patients with~     non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association~     presented the practical guides for oral anticoagulants in NVAF patients, which recommend~     that the optimal time to start anticoagulant therapy should be determined according to the~     stroke severity. However, this recommendation is principally an experts' opinion and is not~     suitable in the clinical practice in Japan.~      RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of~     an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic~     stroke patients with NVAF in consideration of the infarct size, timing of initiation for~     rivaroxaban medication, and other patient characteristics, and thereby to determine the~     optimal timing of the initiation during acute ischemic stroke. The consecutive acute~     ischemic stroke / transient ischemic attack (TIA) patients with NVAF who are treated with~     rivaroxaban will be enrolled. The infarction size at 0-48 hours after stroke onset will be~     measured by the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is~     recurrent ischemic stroke within 3 months. The primary safety endpoint is major bleedings~     within 3 months. The optimal timing to initiate rivaroxaban during acute ischemic stroke is~     determined by analysis of co-relation between primary endpoints and the infarct size / time~     to initiate rivaroxaban.~   "
70855|NCT02129907|"~     In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned~     for inclusion in this trial. After signing an informed consent a blood sample will be~     obtained from each participant before iron treatment. The investigators will measure the~     thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT).~     patient will go face to face interview and will be asked to answer structured questionnaire~     which will include information on demographics, clinical data ( fever, allergies , etc.) and~     comorbidities~      Two weeks after completing intravenous iron administration additional blood samples will be~     taken: thrombin generation will be measured~   "
70856|NCT02129894|"~     To see if the use of Abdominal Binders improves patients out comes after cesarean delivery~   "
70857|NCT02129881|"~     A study to assess cell therapy as a treatment to prevent kidney transplant rejection. The~     trial will involve purification of naturally occurring regulatory T cells (nTregs) from~     living-donor renal transplant recipients. The cells will then be grown in the laboratory and~     re‐infused into the patient five days after the kidney transplant. This trial is part of an~     international European Union funded consortium aimed at evaluating cellular immunotherapy in~     solid organ transplantation (The ONE Study). It is anticipated that immune regulation~     induced by nTreg therapy can eventually be used to recude the need for conventional~     immunosuppression in transplant recipients.~   "
70858|NCT02129868|"~     People with type 1 diabetes need regular insulin injections or continuous delivery of~     insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term~     complications. However, achieving treatment goals can be very difficult due to the risk of~     low glucose levels (hypoglycaemia). One solution is to use a system where the amount of~     insulin injected closely matches the blood sugar levels on a continuous basis. This can be~     achieved by what is known as a closed loop system where a small glucose sensor placed~     under the skin communicates with a computer containing an algorithm that drives a~     subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical~     research facility environment, in Cambridge, United Kingdom, as well as several other~     centres have shown that closed-loop glucose control is superior to usual insulin pump~     therapy. The next logical step in the development pathway is to test closed loop systems in~     the home environment. An essential requirement for conducting closed-loop studies outside~     clinical research facility is an automated system where wireless data transmission takes~     place between the glucose sensor and insulin pump.~      The purpose of the present study is to evaluate the efficacy and safety of automated~     overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel~     system which has greatest potential for use in the home setting. The study will take place~     at a clinical research facility on two occasions, using a standardised protocol. The~     performance of the closed-loop system will be evaluated on day 1 of continuous glucose~     monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and~     experience gained from this study will be used for further refinements and development of~     the system for future home use.~   "
70859|NCT02129855|"~     The work will evaluate the metabolic costs for daily activities across the lifespan and~     evaluate the influence of having functional impairments.~   "
70860|NCT02129842|"~     The purpose of this study is to assess whether normal endothelial function in patients with~     Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable~     clinical outcome and maintaining sinus rhythm following ablation~   "
70861|NCT02129829|"~     The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the~     European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps~     required to successfully treat patients with chronic hepatitis B virus infection to prevent~     cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B~     using a point of care test is feasible and effective. The second is to monitor linkage from~     screening into care. The third is to evaluate cheap non-invasive assessments to determine~     the need for treatment. The fourth is to determine what proportion of patients meet~     treatment eligibility criteria. The fifth step is to establish a treatment cohort which can~     be used to measure adherence to therapy and avoidance of HBV related complications. A~     parallel untreated cohort will be established to determine whether treatment criteria are~     relevant in this West African setting by monitoring for complications of HBV infection.~   "
70862|NCT02129816|"~     Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with~     anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a~     trend for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group~     - treated with chewing tablets containing 50% of dried BP leaf press juice - than in the~     placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum~     versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in~     an experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in~     a clincial trial (Purpose 2).~   "
70863|NCT02129803|"~     This study is a single center, randomized pilot study to evaluate the clinical effectiveness~     of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.~   "
72437|NCT02109211|"~     The purpose of this study is to see whether altering the angle of the Magill forceps by 45~     degrees will affect nasal intubation time in pediatric dental surgery patients.~      The null hypothesis is that their will be no difference between the nasal intubation times~     of those patients intubated with the conventional Magill forceps and those intubated with~     the altered Magill forceps.~   "
70868|NCT02129738|"~     The purpose of this study is to investigate and document real life safety and satisfaction~     of re-use of urethral catheters for intermittent self catheterization. The study will~     collect re-used catheters from included patients and compare those to a control group with~     regard to bacterial contamination and mechanical properties. A four week prospective~     evaluation will follow where the patients will be given catheters intended for single-use.~   "
70869|NCT02129725|"~     Our research proposal will determine if PDE-5 inhibition exerts a favorable effect on~     insulin signaling pathways in skeletal muscle of subjects with impaired fasting glucose~     and/or impaired glucose tolerance.~   "
70870|NCT02129712|"~     This research will leverage novel pilot research conducted by the investigators to take~     important first steps in addressing neurocognitive late effects by intervening early, during~     treatment, with a promising computerized cognitive remediation program to prevent the~     downward trajectory of neurocognitive function experienced by pediatric brain tumor~     survivors. Specifically, we propose to test the feasibility, acceptability, and initial~     proof of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to~     train working memory (WM) and attention in newly diagnosed youth with a brain tumor.~     Further, we will test the feasibility of using this intervention in a true prospective~     design beginning pre-surgery to examine the effects of this intervention in deflecting the~     downward trajectory of cognitive function in children with brain tumors during treatment. We~     will also use functional neuroimaging (near infrared spectroscopy - NIRS) to examine the~     effects of this program on brain activation in frontal regions that are affected by~     treatment. Findings from this pilot study will inform the development of a large multi-site~     randomized efficacy trial to test an individualized cognitive training program.~      Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with~     newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks,~     delivering the Cogmed computer-based training program in a randomized trial at 10-weeks~     post-diagnosis, and following patients to 1 year post-diagnosis.~      Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on~     cognitive function in newly diagnosed pediatric brain tumor patients.~   "
70871|NCT02129699|"~     The purpose of this study is to investigate how well the standard treatment (chemotherapy)~     in combination with denosumab works compared with the standard treatment alone in patients~     with a type of lung cancer called non small cell lung cancer (NSCLC) that has spread to~     other parts of the body.~   "
70872|NCT02129686|"~     This study is being done to evaluate the potential benefits of using acupuncture to reduce~     symptoms of tingling, burning, numbness and pain in the hands and feet of women with~     peripheral neuropathy after completion of chemotherapy for breast cancer.~   "
70873|NCT02129673|"~     Slow release formulation of latanoprost is compared for safety and pressure-lowering~     efficacy with topically administration of commercially available latanoprost in patient with~     glaucoma and ocular hypertension~   "
70874|NCT02129660|"~     The purpose of the study is to assess the safety of 2 doses of DRM04B compared to 2 doses of~     DRM04 and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when~     applied once daily for 4 weeks followed by a 2-week post-dose period.~   "
70875|NCT02129647|"~     The purpose of this study is to determine if the study drug, AXITINIB, has any effect on~     tumors found in patients with Neurofibromatosis Type 2 (NF2).~   "
70876|NCT02129634|"~     Background~      - In patients with critical limb ischaemia (CLI), the infragenicular arteries are often~     involved. Without revascularisation, amputation often is imperative. There is a high~     technical success rate of endovascular revascularisation of infragenicular arteries with~     percutaneous transluminal angioplasty (PTA), but mid- and long-term results are~     disappointing as restenosis frequently occurs. Drug-eluting balloon (DEB) PTA has been shown~     to improve patency rates after PTA of coronary arteries.~      Aim~        -  To study the results of DEB-PTA compared to conventional balloon CB-PTA for the~          treatment of infragenicular lesions in patients with CLI.~        -  To evaluate cost-effectiveness of DEB-PTA versus CB-PTA in patients with critical limb~          ischemia (CLI) by quantifying the incremental cost-effectiveness ratio (ICER).~      Hypothesis~        -  DEB PTA results in improved patency rates compared to CB-PTA for treatment of~          infragenicular arterial lesions in patients with CLI.~        -  DEB-PTA is a cost-effective strategy in patients with CLI compared with CB-PTA.~      Methodology Multi-center, prospective, randomised parallel-group trial. Patients are~     eligible for enrolment if they have CLI and at least one infragenicular lesion with a~     maximal total lesion length of 20cm. Randomisation will be performed on a 1:1 ratio to~     either DEB-PTA or CB-PTA. Patients will be assessed prior and directly after the~     intervention, at 3, 6 and 12 months by Rutherford classification, ankle-brachial index, toe~     pressure and adverse events. Duplex will be performed at 3 months. Angiography will be~     performed before and directly after PTA and at 6 months. Primary end-point will be primary~     patency of the treated lesions at 6 months on angiography (defined as <50% stenosis, without~     re-intervention in the interim). Secondary end-points are limb salvage at 3, 6 and 12~     months, primary patency of the treated lesion on Duplex at 3 months (defined as patency of~     the treated artery with peak systolic velocity (PSV) ≤2.0 m/sec), Rutherford classification,~     minor and major amputation, infrapopliteal endovascular re-intervention, patency of treated~     femoropopliteal sites (if applicable), infrapopliteal surgical bypass, peri-procedural~     complications and death at 3, 6 and 12 months.~      A cost-effectiveness analysis (CEA) from a societal perspective will be performed in~     parallel with the randomized clinical trial with a 12-month time horizon.~   "
70877|NCT02129621|"~     Aldosterone and its target the mineralocorticoid receptor are implied in development of~     cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum~     aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or~     not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity.~     The first candidate biomarker is Neutrophil gelatinase-associated lipocalin (NGAL) or~     lipocalin which being measured in blood or in the urine. According to scientific~     knowledge's evolution, others biomarkers could be tested later thanks to the blood or~     urinary samples taken during study.~   "
70878|NCT02129608|"~     Currently in the United States about 97 million adults are considered obese, accounting for~     about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as~     a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the~     ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0~     Laser (which will be used in this study) has been approved by the FDA (K123237) as a~     non-invasive dermatological aesthetic treatment which can be used by individuals intending~     to reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C~     (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is~     believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on~     anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by~     the FDA on June 2012 for weight management in people with a BMI of > 27 kg/m2 (overweight)~     when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure~     or in people with a BMI > 30 kg/m2 (obese). The purpose of this pilot study is to obtain~     preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing~     abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on~     inflammatory biomarkers, blood sugar, and cholesterol.~   "
70879|NCT02129595|"~     The main objective of the study is to investigate if resveratrol supplementation can improve~     overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic~     patients.~      As a secondary objective the investigators want to investigate whether the improved insulin~     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a~     reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants~     the investigators want to investigate the effect of resveratrol on glucose uptake in brown~     adipose tissue.~   "
70880|NCT02129582|"~     This phase I trial studies the side effects and best dose of targeted marrow irradiation~     when given with fludarabine phosphate and busulfan before donor progenitor cell transplant~     in treating patients with hematologic malignancies. Targeted marrow irradiation is a type of~     specialized radiation therapy that delivers a high dose of radiation directly to the cancer~     cells, which may kill more cancer cells and cause less damage to normal cells. Giving~     targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and~     busulfan, before a donor progenitor cell transplant may help stop the growth of cancer~     cells. It may also stop the patient's immune system from rejecting the donor's progenitor~     cells. When the healthy progenitor cells from a donor are infused into the patient they may~     help the patient's bone marrow make progenitor cells, red blood cells, white blood cells,~     and platelets.~   "
70881|NCT02129569|"~     This pilot clinical trial studies how well psychoeducational and behavioral strategies work~     in reducing distress and anxiety in patients with multiple myeloma and their family~     caregivers. Education and walking programs, may be able to reduce distress and anxiety and~     improve the well-being and quality of life of patients with multiple myeloma and their~     family caregivers. Understanding how different forms of education and support can promote~     emotional wellness may help nurse researchers find ways to improve services provided to~     patients and family members during cancer treatment.~   "
70882|NCT02129556|"~     A significant amount of preclinical and correlative clinical data suggest that HER2-positive~     breast cancer could be amenable to immune¬therapeutic approaches. The presence of~     HER2-overexpression in breast cancers is associated with higher levels of proliferation,~     high histologic grade and higher levels of tumor infiltrating lymphocytes (TILs) compared~     with HER2-negative tumors. The investigators therefore hypothesize that for HER2-positive~     tumors, avoidance of destruction by the host immune system must be an important mechanism~     contributing to tumor growth and progression.~      The term immune evasion refers to the ability of the tumor to suppress and change host~     anti-tumor immune reactions. The programmed cell death 1 (PD-1) pathway represents a major~     immune control switch which may be engaged by tumor cells to overcome active T-cell immune~     surveillance. The ligands for PD-1 (PD-L1 and PD-L2) are constitutively expressed or can be~     induced in various tumors. High expression of PD-L1 on tumor cells (and to a lesser extent~     of PD-L2) has been found to correlate with poor prognosis and survival in various other~     solid tumor types. Furthermore, PD-1 has been suggested to regulate tumor-specific T-cell~     expansion in patients with malignant melanoma. These observations suggest that the~     PD-1/PD-L1 pathway plays a critical role in the tumor immune evasion and could be considered~     an attractive target for therapeutic intervention in several solid organ types.~      MK-3475 (previously known as SCH 900475) is a potent and highly-selective humanized mAb of~     the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its~     ligands, PD-L1 and PD-L2. MK-3475 strongly enhances T lymphocyte immune responses in~     cultured blood cells from healthy human donors, cancer patients, and primatesMK-3475 also~     modulates the level of interleukin-2 (IL-2), tumor necrosis factor alpha (TNFα), interferon~     gamma (IFNγ), and other cytokines.~      The investigators therefore propose to evaluate if the addition of an immunotherapy can~     reverse trastuzumab resistance and improve clinical outcomes in HER2-positive disease. In~     this study the investigators will determine if a monoclonal antibody targeted against PD-1,~     a T cell negative regulator, can reverse trastuzumab resistance in patients previously~     progressing on trastuzumab.~   "
70883|NCT02129543|"~     The investigators are collecting blood samples to learn more about how the body's immune~     system recovers after stem cell transplant (SCT). Participants are either previous~     recipients of a stem cell transplant, or a donor of stem cells for transplant.~   "
70884|NCT02129530|"~     The overall purpose is to assess whether a community social mobilization (CSM) program~     focused on young men ages 18-35 years of age changes gender norms in the community. The~     secondary purpose is to determine if there is a combined effect of CSM and HPTN 068~     (Conditional Cash Transfers) on HIV and HSV-2 incidence. The goal of the mobilization~     activities is to engage young men around the issues of gender norms, intimate partner~     violence and HIV risk and to encourage them to take action to protect young women and reduce~     HIV risk in their communities.~   "
70885|NCT02129517|"~     This pilot, randomized clinical trial studies a web-based tailored educational program in~     improving nurse communication with patients about clinical trial treatment options. A~     web-based tailored educational program may empower and prepare nurses to discuss clinical~     trial treatment options with patients and may also increase patient participation in~     clinical trials.~   "
70886|NCT02129504|"~     Gingival recessions are often successfully treated by coronally advanced flap technique~     (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the~     xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF~     technique for root coverage. CAF technique was not developed for use with CM and has shown~     limited results when applied to the CM. The aim of this study was to compare and show the~     benefits of the extended flap technique (EFT) compared to CAF technique using CM for root~     coverage.~   "
70887|NCT02129491|"~     Our aim is to establish multi-center national Egyptian database of information about~     cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.~   "
70905|NCT02129257|"~     The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in~     metastatic colorectal cancer patients) trial is an investigator-initiated, single arm,~     open-label, phase II study. Patients with histologically proven metastatic colorectal~     carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both~     Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients~     wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the~     combination of chemotherapy and aflibercept, the patient will be treated with a maintenance~     therapy with aflibercept alone until PD or unacceptable toxicity, investigator's decision or~     patient's refusal of further treatment or death, whichever comes first.~   "
70931|NCT02128919|"~     This is a study of the effects of tDCS on smoking , craving for cigarettes, cognition, and~     psychiatric symptoms in schizophrenic patients who are current smokers or have a history of~     regular cigarette smoking. It assesses smoking with CO mentoring, nicotine and cotinine~     levels, and craving with QSU scale and response to craving slides. Cognition is measures by~     MATRICS battery, symptoms are measured by PANSS scale and hallucination scale.~      This is double-blind sham-controlled study, with active tDCS 2ma or 20 minutes over 5 days,~     and sham tDCS for 40 seconds on each sham occasion.~   "
70888|NCT02129478|"~     Olanzapine is licensed for use in adults in Canada and in teens in the US with mental~     illness. It is also often used for the management of mental illness in children. This study~     will describe the feasibility of giving olanzapine plus other usual medications to prevent~     chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.~      What has been done already? - In adult cancer patients, olanzapine improved the control of~     CINV. None of the adults studied experienced any serious side effects from olanzapine.~      What is being studied and how will the study be conducted? - On each day that chemotherapy~     is given, olanzapine will be given to 15 children along with their regular medications to~     prevent CINV. Investigators will study each child only during one chemotherapy cycle.~     Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride~     levels, blood pressure, weight, mood and behavior during the time they receive olanzapine~     will be evaluated to see if they change. Investigators will record anything serious that~     happens while children receive olanzapine. If any child stops olanzapine early or decides to~     decrease the dose, the reason will be recorded. Each child and their guardian will record~     their nausea severity and the times they vomit or retch on each day they receive~     chemotherapy and for 8 days afterwards.~      How will the study help? - This study will help investigators decide if it is feasible to~     conduct a larger study to find out if olanzapine improves CINV control in children. If most~     children are able to take olanzapine as set out in the study without having significant side~     effects, then a larger study would be feasible.~   "
70889|NCT02129465|"~     Analysis of several characteristics of blood from pregnant women with CMV infection~     according to maternal-fetal transmission. These include CMV viral load, cytokine profile in~     response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV~     antibodies, maternal DNA polymorphism and microarray of gene expression.~   "
70890|NCT02129452|"~     The purpose of this study is to evaluate the olfactory neuroepithelium as a biomarker of~     Alzheimer disease. The early diagnosis of Alzheimer disease is of importance for obtaining~     better response to treatment, but recently reported biomarkers have some limitations.~     Olfactory neuroepithelium tissue which is accessible through office-based biopsy without~     difficulty is known to reflect brain pathology that confirms the diagnosis of Alzheimer~     disease. This study will help in the early detection and treatment of Alzheimer disease.~   "
70891|NCT02129439|"~     Ulcerative colitis (UC) represents one of the major entities of idiopathic inflammatory~     bowel diseases which are defined as chronically relapsing inflammations of the~     gastrointestinal tract not due to specific pathogens. It is characterised by a superficial,~     continuous mucosal inflammation, which predominantly affects the large intestine. The~     clinical course is typically marked by periods of asymptomatic remission punctuated by~     unpredictable recurrent attacks. The symptoms of the patients are marked by persistent~     diarrhoea with severe faecal urgency and often incontinence, rectal bleeding, abdominal~     cramping and weight loss.~      Uncontrolled activation of mucosal effector T cells has been identified as the main~     pathogenic mechanism involved in the initiation and perpetuation of intestinal inflammatory~     reactions.~      Patients with moderate UC are initially treated with mesalazine, applied both orally and~     rectally. If symptoms do not improve, systemic corticosteroids are to be administered.~     Patients who do not respond to systemic corticosteroids may become eligible for treatment~     with a calcineurin inhibitor or an anti-tumor necrosis factor (TNF)α antibody.~     Alternatively, patients may have to undergo major colorectal surgery.~      Patients who do not adequately respond to these treatment strategies exhibit serious~     drawbacks. Colorectal surgery may result in a severely compromised quality of life.~      Therefore, patients with moderate or severe UC may significantly benefit from new~     therapeutic alternatives.~      The transcription factor GATA-3 is an interesting target for a novel therapeutic strategy in~     UC.~      GATA-3 is the key regulation factor of Th2-driven immune responses. It is indispensable for~     the differentiation and activation of Th2 cells, integrates Th2 signals, and induces Th2~     cytokine expression. Results of a recent clinical trial in children showed that GATA-3 is~     involved in the pathogenesis of the acute phase of UC.~      The investigational product SB012 contains the DNAzyme hgd40 that targets GATA-3. By~     cleaving GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key~     features of mucosal inflammation.~      DNAzymes are completely generated by chemical synthesis, not by use of any living organism~     and are therefore not biological drugs.~      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of the~     topical formulation SB012 available in a concentration of 7.5mg/ml hgd40 in 30ml PBS once~     daily as a ready-for-use enema in patients with active UC.~   "
70892|NCT02129426|"~     This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are~     used with another sedating medicine called Dexmedetomidine for MRI sedation. This study~     hopes to measure the impact each drug has on what happens during and after MRI sedation with~     Dexmedetomidine~   "
70893|NCT02129413|"~     The purpose of this study is to evaluate the safety and performance of the Delta system in~     the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.~   "
70894|NCT02129400|"~     The purpose of this study is to analyze the effect of xenon-inhalation on~     erythropoetin-level in blood of healthy volunteers and to determine the efficient time of~     inhalation.~      Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood~   "
70895|NCT02129387|"~     The purpose of the proposal is to identify new predictors of smoking progression in young~     light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to~     relate these predictors of progression to the genetic profile most highly associated with~     smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors~     will include individual differences (IDs) in EEG, reward sensitivity, attentional~     performance, and mood during abstinence and in response to standardized and to self-selected~     acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking~     history. The associations of a compelling genetic functional variant polymorphism,~     rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking~     progression and the novel predictors. The study is expected to provide insights into IDs in~     mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to~     targeted pharmacotherapy and behavioral interventions for at-risk YLS.~   "
70906|NCT02129244|"~     The researchers of this study are observing the treatment of multi-drug resistant~     Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the~     usual TB drugs and needs to be treated with special drugs. The patients need to take these~     drugs for up to two years. Certain hospitals have already agreed to participate in this~     research project, half of the hospitals will be assigned a nurse case manager and the other~     half will not. The researchers are studying the benefits of having a nurse case manager to~     improve treatment response for patients with drug resistant TB. The researchers believe that~     nurse case management (NCM) in the intervention sites will increase MDR-TB cure and~     completion rates (i.e. treatment success) in comparison to usual care (UC), i.e.~     standardized programmatic management alone, in patients with and without HIV co-infection.~     To do this, the researchers will review the medical information collected at the hospital as~     part of the patient's treatment after obtaining the patient's permission.~   "
70896|NCT02129374|"~     Lumbar spondylolysis is a relatively common condition that causes severe and perennial back~     pain in young populations. Conservative treatment of this condition may be futile, and may~     eventually require surgical treatment such as direct repair of pars defect and a segmental~     lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment~     methods for spondylolysis, direct repair surgery of pars defect has been focused due to its~     inherited strengths. Most importantly, fusion surgery caused the affected segment to lose~     the nature range of motion and furthermore adjacent segment to be adversely affecting such~     as adjacent disc disease or degeneration, while direct repair theoretically could preserve~     the motion of the affected segment, which do not cause the adjacent segment problems as~     being the fusion surgery, as well as could produce better surgical outcomes with relatively~     less invasive technique as compared to fusion surgery. Moreover, previous articles have~     demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve~     great functional and radiological outcomes. However, most of the previous studies was~     conducted using lower level designed study such as retrospective and small sample size,~     thereby prior literature does not provide clear information on the therapeutic outcome of~     direct repair for lumbar spondylolysis, especially for managing spondylolysis of young~     population.~      Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair~     surgery for lumbar spondylolysis in young population. To our knowledge, this is the first~     report that describes the functional and radiological outcomes of direct repair for~     spondylolysis in young populations with prospective cohort study design and relatively large~     sample size.~   "
70897|NCT02129361|"~     This study is investigating one way to improve health and healthy habits after traumatic~     brain injury (TBI). The primary goal of this study is to determine if a brief intervention~     accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse~     during the year following injury. It is hypothesized that an adapted Screening, Education~     and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per~     week over the year following discharge from inpatient rehabilitation, in comparison to a~     Screening and Education Attention Control condition (SEA control).~   "
70898|NCT02129348|"~     Clinically, many patients with AD show no response or minimal response to antipsychotics for~     symptoms of agitation/aggression or psychosis, or they have intolerable side effects on~     these medications. Antipsychotics have a wide range of side effects, including the risk of~     increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that~     led to an FDA black box warning for patients with dementia; a more recent review and~     meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only~     partial response to antipsychotics and symptoms persist. For these reasons, the~     investigators need to study alternative treatment strategies. Currently, there is no~     FDA-approved medication for the treatment of psychosis or agitation in AD.~      The investigators innovative project will examine the efficacy and side effects of low dose~     lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD~     in a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II~     trial). The results will determine the potential for a large-scale clinical trial (Phase~     III) to establish the utility of lithium in these patients.~   "
70899|NCT02129335|"~     Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS)~     tumor in adulthood with a median survival of 12-16 months. The drastically shorted life~     expectancy, intellectual changes and rapid physical decline in those patients are~     devastating and do impose a profound chronic stress on patients and their families. There is~     extensive evidence that chronic stress can promote cancer growth and progression. In the~     setting of GBM patients, three major questions still have to be answered and will be~     analysed in this study:~        1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on~          treatment tolerance and (progression free) survival?~        2. Can this stress be modulated by other factors, like stress of patients partners and~          patients physical activity, a known independent prognostic factor in recurrent glioma~          patients?~        3. How is the longitudinal course of patients and partners stress and physical condition~          over the disease course and do they influence (progression free) survival?~      Answers to these questions will help to establish future projects studying non drug~     interventions in patients and patients partners to help improving clinical and tumor related~     outcome in patients with newly diagnosed GBM.~      The investigators hypothesize that chronic stress, specifically measured as a disruption of~     the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM.~     Furthermore, physical activity of patients and stress level in patients` partners may impact~     - as stress-modulating factors- on stress in patients and on their prognosis.~      Aiming at identifying stress-related prognostic factors as potential targets for novel~     treatment approaches, we propose, in a first step, a prospective multicenter cohort study:~     all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo~     standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6~     month of cyclic temozolomide, are eligible. In addition, one partner, defined as a close~     person living in the same home or close daily contact to the patient, will be asked for~     inclusion.~   "
70900|NCT02129322|"~     The study is designed to investigate the effect of adjuvant therapy by Sorafenib,~     Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver~     transplantation~   "
70901|NCT02129309|"~     The investigators are interested in studying how Pulmonary Hypertension occurs. A substance~     called 'apelin', that naturally occurs in the body has been shown to have an important role~     in heart disease. Previous studies have shown that it can make blood vessels get wider, and~     help blood flow around the body and thus improve the way the heart and lungs work.~      The investigators are looking to recruit both healthy and COPD pulmonary hypertension~     patients to study 3 types of apelin. The purpose of this study is to help the investigators~     understand how Pulmonary Hypertension occurs which may will help with the development of~     future treatments.~   "
70902|NCT02129296|"~     Gastric balloons are an evolving way of reducing weight. There are two types on the market,~     up to date. Air filled balloons seem to be more safe, and more tolerable.~   "
70903|NCT02129283|"~     The purpose of this study is to determine whether end-of-life training of ICU professionals~     leads to improvements in ICU care process, teamwork and family satisfaction.~   "
70904|NCT02129270|"~     The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the~     fracture site (Hematoma block) is more effective in terms of pain relieving then injection~     of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction~     of distal radius fractures.~   "
70942|NCT02128776|"~     The purpose of this study is to assess whether an enhanced medical home providing~     comprehensive care is cost-effective in preventing serious illness (death, pediatric~     intensive care admission, or hospital stay >7d) among high-risk chronically ill children.~   "
70943|NCT02128763|"~     The objective of the DREAM study is to evaluate the effectiveness and safety of~     supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry~     eye disease.~   "
70907|NCT02129231|"~     Aims: To evaluate the effect of ezetimibe/simvastatin and rosuvastatin on oxidative stress~     and mitochondrial function in patients with DPN.~      Methods: We performed a randomized, double-blinded, placebo-controlled phase II clinical~     trial in adult patients with type 2 Diabetes Mellitus (T2DM) who had Diabetic Polyneuropathy~     (DPN) evaluated by composite scores and nerve conduction studies (NCS), HBA1C <12% (108~     mmol/mol), previous exclusion of other neuropathies. Ninety-eight persons with T2DM were~     allocated 1:1:1 to either placebo, ezetimibe/simvastatin 10/20 mg or rosuvastatin 20 mg for~     16 weeks, and healthy controls (not randomized) were included for comparisons. Primary~     outcomes were lipid peroxidation (LPO), nitric oxide (NO), and total antioxidant capacity~     (TAC); secondary were clinical, NCS and metabolic parameters. Results were expressed as mean~     ± standard deviation (SD) or standard error of the mean (SEM), frequencies and percentages.~     Non-parametric analysis was used.~   "
70908|NCT02129218|"~     This pilot clinical trial studies the feasibility of a low glycemic load diet in patients~     with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores~     on the glycemic index. The glycemic index is a scale that measures how much a certain~     carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help~     decrease the chance of cancer coming back and improve the survival in patients with colon~     cancer.~   "
70909|NCT02129205|"~     To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
70910|NCT02129192|"~     To investigate the steady state pharmacokinetics of different formulation of Telmisartan,~     Amlodipine, and Hydrochlorothiazide (HCTZ).~   "
70911|NCT02129179|"~     This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and~     transpulmonary gradient in patients undergoing right heart catheterisation for clinical~     reasons.~   "
70912|NCT02129166|"~     This research study is looking at how imatinib affects how dasatinib is absorbed and~     eliminated from the body. Both imatinib and dasatinib are in a class of medications called~     tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia~     (cancer that begins in the white blood cells). Both imatinib and dasatinib have been given~     safely in healthy volunteers. In this study investigators will evaluate the pharmacokinetics~     interaction between imatinib and dasatinib when they are co-administered. The hypothesis is~     that imatinib will increase the blood levels of dasatinib through inhibiting the drug~     metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and~     removal. This research will provide important new insight of combination TKI therapy in~     terms of transporter- and enzyme- mediated pharmacokinetic interactions. The research~     results will also help guide doctors in knowing how much of a tyrosine kinase inhibitor to~     give safely while reaching best effect in TKI combination therapy.~   "
70913|NCT02129153|"~     In this study, we will evaluate the efficacy and sustainability of the Linking Families~     Together (LIFT) intervention to improve parental monitoring during the transition from~     middle to high school a particularly risky time for students' academic performance and~     health behaviors. This study is based in middle schools around Los Angeles County a region~     with a high prevalence of teen risky health behaviors.~      The aims of our study are:~        1. To conduct a randomized trial of the LIFT intervention and examine whether providing~          detailed academic information to parents during their child's 7th and 8th grade~          increases parental monitoring at the end of the two year intervention and one year~          follow up. We will partner with 3-10 middle schools and recruit 500 student-parent~          dyads: 250 will be randomized to the intervention arm and 250 to the usual care control~          group.~        2. To determine whether the LIFT intervention improves students' academic outcomes, as~          measured by grades, attendance, and standardized test scores at the end of the two year~          intervention and one year follow up.~        3. To evaluate whether the LIFT intervention lowers rates of adolescent risky health~          behaviors, specifically substance use (alcohol, marijuana, inhalants, and other drugs)~          at the end of the two year intervention and one year follow up.~   "
70914|NCT02129140|"~     The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the~     repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is~     indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently~     FDA-approved for implantation to reinforce soft tissues where weakness exists, but the~     investigators would like to collect additional follow-up information to continue to assess~     the durability of the repair after placement of the hernia mesh. This follow-up would~     include the collection of information about complications such as infections and seromas~     (collections of fluid around the surgery site), as well as hernia recurrence and quality of~     life questionnaires. Patients who qualify to take part in this study have been diagnosed~     with a ventral incisional hernia and will have been scheduled for a surgical hernia repair.~     This surgery will be an open surgical procedure and reinforcing your tissue with material~     is indicated for this type of hernia repair.~   "
70915|NCT02129127|"~     This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for~     percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.~     The study focuses on acute device performance and peri-procedural safety and also seeks to~     further characterize the performance of the device.~   "
70916|NCT02129114|"~     1. Most of dural defects may lead to subcutaneous effusion and Cerebral Spinal Fluid (CSF)~          leakage, which may result in infection; besides, direct adhesion of brain tissues with~          sub-scalp tissues also increase the risk of epilepsy, in severe cases, dural defect is~          considered a life-threatening condition. So, it's important to repair the dura mater~          for restoring its full integrity .~        2. Dural Repair Patch(ReDura Onlay) manufactured by Guangzhou Medprin Regenerative Medical~          Technologies Co., Ltd. As a product made of clinical absorbable polymer materials by~          using bionic technology, Dural Repair Patch has highly bionic 3-dimensional structure~          which is proved to facilitate migration and growth of regenerative cells, as well as to~          accelerate the growth and repairing of regenerative meninges. While the material is~          degraded gradually and absorbed by the body, regenerative meningeal tissue is gradually~          formed, achieving true reconstruction of the dura mater.~        3. To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs~          of dural defects.~   "
70917|NCT02129101|"~     This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or~     decitabine and so see how well they work in treating patients with myeloid malignancies. The~     hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation~     and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular~     proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo.~     Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of~     the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving azacitidine together with sonidegib or decitabine may be a safe and successful~     treatment for patients with myeloid malignancies.~   "
70918|NCT02129088|"~     The purpose of this study is to compare the pharmacokinetics (explores what the body does to~     the drug), safety and tolerability of esketamine, administered intranasally (administered~     through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.~   "
70919|NCT02129075|"~     This randomized phase II trial studies how well DEC-205/NY-ESO-1 fusion protein CDX-1401~     (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work~     when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage~     IIB-IV melanoma. The cancer vaccine CDX-1401 attaches to a protein that is made in tumor~     cells. The vaccine helps the body recognize the tumor to fight the cancer. The CDX-301~     vaccine may help the body make more of the tumor fighting cells, known as dendritic cells.~     The poly-ICLC vaccine stimulates the immune system and may help these dendritic cells mature~     so that they can recognize the tumor. It is not yet known whether CDX-1401 and poly-ICLC~     will work better with or without CDX-301 in treating melanoma.~   "
70920|NCT02129062|"~     This phase II trial studies how well ibrutinib works in treating patients with B-cell acute~     lymphoblastic leukemia that has come back after treatment or has not responded to other~     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
70921|NCT02129049|"~     This pilot clinical trial studies the feasibility of a telephone-based educational~     intervention in improving communication between patients with stage 0-III cancer and their~     children. An educational program delivered by telephone may help parents talk with their~     school-age child about their cancer.~   "
70922|NCT02129036|"~     Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40%~     of the patients with clear cell carcinoma are diagnosed in the advanced stage. The~     investigators studied the response to chemotherapy and survival for either~     paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all~     stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with~     pure, advanced, clear cell ovarian carcinoma were also evaluated.~   "
70923|NCT02129023|"~     The purpose of this study is to examine whether exergame use can improve user health, in~     terms of physical fitness, self-rated mental health and physical health, and favorable~     attitude, strong intention, and actual behavior of future exercise. Moreover, this study~     also examines whether past exercise moderates the impact of exergame use on user health.~   "
70924|NCT02129010|"~     Prospective clinical study to investigate the pathogenesis of Terson syndrome and the~     prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with~     aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:~        1. The incidence of Terson syndrome correlates with the initial intracranial opening~          pressure (measured with extra ventricular drain)~        2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and~          12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as~          well as with complications related to aneurysmatic subarachnoid hemorrhage such as~          cerebral vasospasm, delayed cerebral ischemia and re-bleed.~   "
70925|NCT02128997|"~     This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed~     incisions decreases the risk of wound complications among obese patients after cesarean~     section~      All patients having a cesarean section in labor or presenting to the triage unit and~     requiring a cesarean section will be eligible~      Main study intervention: this involves the use of a negative pressure wound vacuum therapy~     on a closed incision.~   "
70926|NCT02128984|"~     The purpose of this study is to determine whether a nutritional supplement is effective in~     the treatment of malnutrition in pediatric patients with failure to thrive or cystic~     fibrosis.~   "
70927|NCT02128971|"~     The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5~     different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and~     ferric glycinate) at the same dose (90mg) and placebo.~   "
70928|NCT02128958|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in~     subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1~     prior systemic drug therapy for HCC.~   "
70929|NCT02128945|"~     The application of positron emission tomography with lymphoproliferative diseases today~     provides diagnostic and therapeutic information of major importance , especially in terms of~     speed and quality of response to treatment. The radiopharmaceutical used in clinical~     practice for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose~     fluorodeoxyglucose ([18F]-FDG) . However , the uptake of this tracer is not elective in~     lymphoid tissues , with a lack of specificity. In addition , the avidity of this tracer is~     unequal according to the histological subtype (lack of sensitivity).~      To try to improve the results of this clinical exploration of lymphoid malignancies, the~     investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of~     transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine~     atom in the molecule and the pharmacokinetic characteristics of this drug. The~     [18F]-Fludarabine is a new radiopharmaceutical reproducing the same dosage formulation of~     fludarabine , a drug used for the treatment of certain types of lymphoproliferative~     diseases, especially those where the tumor cells have a low proliferation kinetics . This~     drug is used in therapy in particular pharmacokinetic effect for a high affinity for the~     lymphoid tissue . Preclinical results on normal and lymphoma xenograft -bearing mice showed~     a specificity restricted to lymphoid tissue fixation with [18F]-Fludarabine compared with~     [18F]-FDG .~      Based on these encouraging results , the investigators propose in this work to explore the~     Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases :~     1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has~     a wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with~     chronic lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered~     disappointing and did not, for this reason, experienced clinical development.~   "
70930|NCT02128932|"~     This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of~     the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide~     versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in~     insulin-naïve subjects with type 2 diabetes.~   "
70932|NCT02128906|"~     The goal of this clinical research study is to learn which chemotherapy combination may be~     more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC).~     The side effects of these combinations will also be studied.~      This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent~     chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the~     combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status~     and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will~     evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which~     radiation and chemotherapy combination works best in relationship to how much ERCC-1 [4F9]~     is expressed in a tumor.~   "
70933|NCT02128893|"~     The purpose of this study is to assess the effect of multiple doses of esomeprazole on the~     pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole~     alone and in combination with esomeprazole will be assessed~   "
70934|NCT02128880|"~     The goal of the proposed research is to develop and pilot test a novel Internet intervention~     to reduce the risk of Alcohol-exposed pregnancy (AEP). Efficacious interventions to reduce~     the risk of AEP have been developed, but are not widely available. In this project, we will~     develop a novel Internet intervention to reduce AEP risk by combining the resources of two~     research teams focused on primary prevention of Fetal Alcohol Spectrum Disorders (FASD) and~     robust Internet interventions, respectively. We will use our evidence-based AEP risk~     reduction intervention materials and our existing Internet intervention development platform~     to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction~     Internet Intervention, CARRIII) in a stage 1 behavioral and integrative therapies~     development project.~      This three year R34 project will develop and program the new Internet intervention, and will~     determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. In~     this protocol, we will assess the feasibility and preliminary efficacy of CARRIII against a~     Patient Education Website condition in a pilot randomized clinical trial (RCT) with~     assessments at pre-, post-, and 6 months.The primary hypothesis is that women randomized to~     the CARRIII condition will change more in 3 markers of AEP-related outcomes (risky drinking,~     ineffective contraception, and AEP risk) than women assigned to the Patient Education~     website condition. We will prepare for a future cost effectiveness evaluation in the larger~     RCT to follow by pilot testing proposed measures. The pilot RCT will yield effect size~     estimates for a subsequent fully powered trial. If the Internet intervention is promising,~     it should be tested in a fully powered national trial. The Internet intervention could~     substantially increase the options for AEP prevention, and could lead to a reduction in~     incident FASD.~   "
70935|NCT02128867|"~     The purpose of this study is to determine whether three airway clearance techniques (~     Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate~     gastro-esophageal reflux in infants under the age of 1 year.~   "
70936|NCT02128854|"~     The purpose of this project is two-fold: (1) to determine the feasibility of recruiting~     rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of~     tablet-based resources in good diabetes self-management behaviors, and (2) to test a~     tablet-aided intervention for improving diabetes self-management behaviors~   "
70937|NCT02128841|"~     Objectives~      Primary objective:~      To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major~     complications in patients undergoing a mechanical aortic heart valve replace-ment.~      Secondary objectives:~      To identify the value of molecular markers suitable for monitoring of anticoagulation~     effectiveness of rivaroxaban and its correlation with transcranial Doppler emboli count in~     patients undergoing a mechanical aortic heart valve replacement.~      Design This is a prospective, open-label phase 2 pilot study with independent evaluation of~     all outcomes and a historical control group.~      Number of patients 30 in experimental group (patients in the center's registry database~     serve as control group).~      Main eligibility criteria All patients between 18 and 70 years old receiving a mechanical~     aortic valve replacement with a pre-operative left ventricular ejection fraction >/=35%.~      Interventions Experimental: Rivaroxaban 20mg p.o., once daily, for six months Historical~     control: Phenprocoumon (Marcoumar) p.o., once daily Outcomes~      Primary outcome:~      Composite outcome of prosthetic thrombus requiring reoperation/intervention, major bleeding,~     visceral ischemia, stroke, pulmonary embolism, myocardial infarction or death from any cause~     180 days after intervention.~      Secondary outcomes:~      Each component of the composite outcome plus serious adverse events. Prosthetic thrombus~     requiring reoperation/intervention plus non-clinically relevant thrombi will be used as an~     additional safety outcome.~      Molecular markers suitable for monitoring the effectiveness of rivaroxaban.~   "
70938|NCT02128828|"~     The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals~     with cognitive impairment. The investigators will study the effect of cenicriviroc on~     cognition in 24 subjects over a 24 week period.~   "
70939|NCT02128815|"~     Background: Health coaching is defined as health education, promotion and support by a~     professional to enhance the well-being of individuals and facilitate the achievement of~     their health-related goals. However, health coaching has not been adequately assessed in the~     community health care setting in individuals with T2DM. The purpose of this study is to~     determine the effect of diabetes health coaching in adults with T2DM in the community health~     care setting on clinical outcomes, self-care behaviours and health care utilization.~   "
70940|NCT02128802|"~     Gastric Bypass followed by renal transplantation is superior to medical management followed~     by renal transplant for patients with severe obesity and renal failure.~   "
70941|NCT02128789|"~     Technology has been created to help older adults age well in their homes, but adoption and~     acceptance have been slow. The researchers are developing a low-cost web-based technology,~     called Elder Tree, for older adults and caregivers to address key challenges older adults~     face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from~     proven falls prevention strategies, and unreliable home services. Elder Tree is being~     developed and tested with older adults and caregivers to identify, 1) usability issues such~     as font size, navigation and interface (audio, video,text) and 2) content and tailoring~     issues such as identifying local resources and events. This study will employ a randomized~     longitudinal design comparing a control group to an intervention group over a 12-month~     period. Investigators hypothesize that older adults using Elder Tree will experience greater~     independence and quality of life when compared to the control group. Investigators will use~     quantitative measures to determine how much our intervention improves: quality of life and~     health system use. These measures will help us to determine the cost effectiveness of Elder~     Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability~     Resource Centers; one urban, one suburban and one rural setting, so to account for~     environmental and community differences. The older adult and their caregiver will be~     randomized to the same treatment group. Investigators will measure the effect over the 12~     month intervention period and a 6 month follow-up period at 18 months.~   "
70945|NCT02128737|"~     This project continues an innovative line of research on how to optimally use sleep as an~     intervention to promote cognitive recovery from, and resistance to, the neurobehavioral~     risks posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to~     affect at least 20% of adults. It can result from medical conditions and sleep disorders, as~     well as work demands, and social or domestic responsibilities. It is associated with~     significant clinical morbidity, and directly causes errors and accidents that are due to its~     adverse neurobehavioral effects on alertness, mood, and cognitive functions. In seminal~     experiments conducted under this grant, we showed that the neurobehavioral effects of~     chronic sleep restriction accumulate to severe levels in a few days, without the full~     awareness of the affected individuals, and that recovery from chronic sleep restriction~     requires more sleep than previously assumed. We also discovered that recovery from chronic~     sleep was illusory, because it masked a heightened neurobehavioral vulnerability to even a~     single post-recovery night of sleep restriction. The implications of these findings are that~     apparent recovery from chronic sleep restriction masks a more severe cognitive response to~     subsequent sleep restriction suggesting that there are longer time constants in the brain~     for neurobehavioral recovery from chronic sleep restriction. In light of this finding, we~     now seek to determine whether additional nights of extended recovery sleep will reduce the~     heightened vulnerability induced by prior exposure to sleep restriction. A total of 87~     healthy adults (ages 21-50) will be studied in the laboratory during a 17-night (N=63) and a~     19-night (N=24) protocol evaluating cognitive, psychological and physiological responses to~     varying recovery days between two sleep-restriction periods. The results will establish the~     number of nights of recovery sleep needed to prevent accelerated deterioration during a~     subsequent period of sleep restriction. The findings will advance theoretical understanding~     of sleep homeostasis and its relationship to cognitive functions, as well as inform theories~     of sleep need, and have substantial implications for sleep biology, for the treatment of~     clinical disorders that regularly disrupt sleep, and for managing lifestyle factors that~     frequently restrict sleep.~   "
70946|NCT02128724|"~     This study will test whether a drug called BKM120 is a safe and effective treatment when~     given to lung cancer patients having radiotherapy treatment. The trial will identify which~     of three possible doses of BKM120 is best to give with lung radiotherapy.~   "
70947|NCT02128711|"~     There is plenty of evidence to suggest that the lung is not uniform. The internal surface~     area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly~     in blood perfusion, temperature, oxygen tension, and pH. Also, particularly in the context~     of respiratory disease, notable differences are present in the structure of epithelial~     cells, cilia, production of mucus, and inflammatory/immune responses. All of these factors~     are known to impact the physiology of bacteria, yet, there is very little understanding of~     how they impact a) the presence/absence of particular bacterial species throughout the~     respiratory tract, or b) the metabolic processes used by these bacteria within the human~     host environment. A greater understanding of the relationships between environmental~     (chemical) gradients in the lungs of diseased patients (particularly those with cystic~     fibrosis) and the microbial communities that are present may lead to novel hypotheses about~     manipulation of the respiratory environment for therapeutic benefit. To investigate this~     further, the investigators propose to use explanted lung specimens from cystic fibrosis~     patients to test the following hypothesis:~      Hypothesis: In patients with cystic fibrosis, bacterial community composition, metabolism~     and environmental chemistry will vary depending on their spatial location within the~     airways.~   "
70948|NCT02128698|"~     The purpose of this study is to determine wether regular physical activity in combination~     with protein supplementation after bariatric surgery can reduce the loss of muscle mass and~     wether a computer-assisted exercise program is more effective than a usual exercise program~     regarding frequency of physical activity, fitness and muscular strength.~   "
70949|NCT02128685|"~     The aim of this study is to determine whether the dydrogesterone therapy is associated with~     reduction in miscarriage in women with first trimester threatened miscarriage. The~     hypothesis is that the dydrogesterone therapy will significantly reduce the risk of~     miscarriage in women with threatened miscarriage.~   "
70950|NCT02128672|"~     Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable~     back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery~     Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant~     superiority of SCS over conventional medical therapy to treat patients with FBSS. Another~     trial has demonstrated superiority of SCS over repeat surgery in the same patient~     population. However, the ability to reliably capture the low back with paresthesia coverage~     has remained challenging and elusive despite numerous strategies designed to overcome this~     limitation. Strategies that have been introduced but so far with limited success include~     transverse multiple lead stimulation, high frequency stimulation, peripheral field~     stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies~     have been able to reliably overcome the long-term problems of paresthesia capture and pain~     relief of the low back.~      This proposal describes a new spinal stimulation technique designed to improve the~     likelihood of low back stimulation by targeting the nerve supply to the two most commonly~     affected pain producing structures in the back, the facet joints and the intervertebral~     disks. The technique has proven to be feasible in a cadaver model with ease of lead~     placement at the desired targets~   "
70951|NCT02128659|"~     The purpose of this study is to learn if a cervical health literacy program is a practical~     and helpful way of improving women's cervical health knowledge and improving cancer~     screening behaviors, and ultimately preventing cervical cancer.~   "
70952|NCT02128646|"~     The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls~     post-operative pain in patients undergoing both open and laparoscopic (minimally invasive)~     abdominal hernia repair surgery.~   "
70953|NCT02128633|"~     Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the~     treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind,~     with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo~     gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%)~     and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner~     blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the~     Baseline, 7, 15 and 30 days.~   "
70962|NCT02128516|"~     this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an~     intermediate profile, rich in leucines and other essential amino acids, can significantly~     enhance muscle mass gain during strength training. This study will compare the efficacy of~     NUTRALYS® to a reference product. If the results of the study demonstrate a significant~     improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be~     considered as an alternative to sports nutrition products, to which many people are~     intolerant.~   "
70963|NCT02128503|"~     This study aims to determine the prevalence of HBV infection in patients with IBD and~     rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load~     and clinical course of IBD patients.~   "
70954|NCT02128620|"~     The objective of this project is to assess the impact of a Game-Based Appointment System on~     both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no.~      An A/B testing methodology will be used. This methodology consist on the redirection of the~     users to two different versions of the website, and therefore allows to assess the~     interactivity of the users according to the design of the webpage and determine which one~     has a higher impact on the clinical settings, and consequently on prevention of STDs.~      For the A/B test we will test the interactivity of two versions of a web page~     www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B~     version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment~     System.~      The Game-Based Appointment System will offer the users the option of booking appointments at~     the venereology department at the University Hospital of North Norway. The system will~     include an automatic priority appointments function, with three levels of prioritization~     (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the~     following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3~     weeks.~      The hypotheses of this research project are:~        1. The number of visits with the health professionals will be larger in the game-based~          appointment group than in the control group.~        2. The number of visits to the educative components of www.sjekkdeg.no will increase after~          the launch of the Game-Based Appointment System functionality.~        3. The number of visits to the educative components of www.sjekkdeg.no will be larger in~          the appointment group than in the control group.~        4. The time spent per visit to the website will be larger in the appointment group than in~          the control group, meaning a higher exposure to health information.~        5. The visitors returning rate is larger in the appointment group than in the control~          group.~   "
70955|NCT02128607|"~     Objectives:~      Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with~     non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional~     disability and kinesiophobia.~      Design:~      A randomized double blinded placebo controlled trial with double arms in accordance with the~     CONSORT statement.~      Subjects:~      Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a~     subgroup of them will be included according to specific inclusion criteria tailored for~     indication of application of SNAG's therapy (Mulligan technique applied on the lumbar~     spine).~      Method:~      Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will~     be treated during a single session, and real/sham SNAG will be applied from a sitting~     position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed)~     from a validated kinematic spine model will be used and recorded with an opto-electronic~     device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and~     kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly~     evaluated before and after treatment to compare both groups with  Two-Way-ANOVA  statistic~     with for factors; time and groups.~   "
70956|NCT02128594|"~     Men who have sex with men make up a majority of incident HIV infections, however few~     effective interventions to prevent HIV transmission among this group exist. African American~     men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is~     understood about how the role of stigma impacts their linkage and retention to health care~     during treatment. Effective strategies for reducing HIV related risk taking are urgently~     needed to prevent further spread of the HIV epidemic. The proposed research will test a~     behavioral intervention, which can be used during routine public health services, designed~     to reduce HIV risks posed by sexual partner selection strategies. The proposed research will~     also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies~     for reducing social barriers to health care treatment rely on a comprehensive and thorough~     investigation into social barriers that affect AAMSM to effectively engage in medical care.~     These areas of research will be focused on for the current trial.~   "
70957|NCT02128581|"~     Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric~     bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given~     that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and~     also that this hormone causes decreased food intake through increased satiation, it is~     reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the~     effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we~     propose a dose-response study to determine whether the compound has effects in a~     dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as~     food intake in the immediate aftermath of a test meal and the subsequent hours.~   "
70958|NCT02128568|"~     This research is a continuation of the Youth Readiness Intervention (YRI) randomized~     clinical trial by adding additional pre and post intervention data collection upon treatment~     of the control group (N=222) with the intervention which was proven effective in the larger~     trial. The overall research has investigated whether participation in the YRI intervention~     will improve emotional regulation, prosocial attitudes/behavior, social support and daily~     and functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which~     will involve treatment of the control group with the effective YRI intervention, the~     investigators will add an additional measure of self-regulation as observed via DNA~     methylation in buccal cells collected via cheek swabs. As before, after the YRI~     intervention, youth will be offered a free educational opportunity at the EducAid program in~     Freetown or in one of its upline/provincial sites. This stage of the research, as in the~     treatment with the main group, will test whether youth enrolled in the YRI psychosocial~     intervention go on to demonstrate improved attendance and behavior in a subsidized education~     program. In the previous phase of the trial, the investigators did observe significant~     effects for the YRI intervention and evidence that the program is indeed effective. For~     instance, post-intervention, YRI youth reported greater improvements in emotion regulation~     (β=0.109, 95%CI 0.026 to 0.191, δ=0.31), prosocial attitudes/behaviors (β=0.149, 95%CI 0.057~     to 0.240, δ=0.38), and social support (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls,~     and greater reductions in functional impairments (β= -0.175, 95%CI -0.299 to -0.050, δ=~     -0.35). Differences in symptoms were non-significant at six-month follow-up for the full~     sample; moderator analyses showed that, for individuals in the top quartile of baseline~     symptoms, YRI youth had greater improvements in emotion regulation and social support than~     controls. At eight-month follow-up, teachers reported that YRI participants were 8.9 times~     more likely to be in school (28.8% v. 4.7%) and showed better attendance (β=3.553, 95%CI~     0.989 to 6.118, OR=34.93) and academic performance (β= -0.954, 95%CI -1.807 to -0.102, δ=~     -1.31).~      In this final phase of the trial as the investigators treat the wait list control group, the~     investigators will test whether intervention effects observed in self-report data on~     improved emotion-regulation are also upheld in biomarker data. Thus, the investigators will~     now provide YRI treatment to the wait list control group and employ the use of biomarkers as~     a measure of the intervention's effectiveness. The objective of the study will be to assess~     whether DNA methylation (collected via cheek swabs of buccal cells) is associated with~     changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis~     that the YRI is associated with improvements emotion-regulation evidence both in self-report~     data on emotion-regulation and in buccal cell DNA methylation. This study will add to the~     evidence base for effective, culturally sensitive mental health services for youth and young~     adults affected by war and other forms of adversity.~   "
70959|NCT02128555|"~     The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better~     clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle~     osteoarthritis, and compare cost-effectiveness of the two treatments~   "
70960|NCT02128542|"~     This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir~     (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans~     with compensated cirrhosis and genotype 2 HCV infection.~   "
70961|NCT02128529|"~     The purpose of this study was to investigate the prevalence of chronic bronchitis in~     patients suffering from moderate to very severe chronic obstructive pulmonary disease~     (COPD), and to assess the difference in exacerbation rates in patients suffering from~     moderate to very severe COPD with chronic bronchitis vs. a population of patients without~     chronic bronchitis.~   "
70964|NCT02128490|"~     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg~     extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release~     (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.~   "
70967|NCT02128451|"~     The use of clonidine as an alternative to epidural opioids offers several potential~     benefits. Clonidine does not have respiratory depressant effects, and the incidence of~     vomiting and pruritus is less frequent compared with that seen after administration of~     epidural morphine.~      Epidural clonidine have focused on the optimal doses of clonidine to be used, rather than~     analyzing the potential advantage of using epidural clonidine versus opioids with respect to~     efficacy and incidence of side effects.~      Epidural fentanyl has been used effectively as an alternative to morphine and has been shown~     to induce fewer complications when compared with epidural morphine. However, the incidence~     of vomiting in patients receiving epidural fentanyl still ranges between 28% and 52%~     depending on the study population and concentration used. The analgesic and side effects~     profile of epidural clonidine compared with epidural fentanyl are unknown.~      The primary aim of this randomized double-blind trial is to test the hypothesis that~     epidural clonidine decreases the incidence of side effects compared with epidural fentanyl.~      Therefore, we compared the hemodynamic effects of the epidural bupivacaine-clonidine-~     fentanyl combination with those of epidural bupivacaine- clonidine- meperdine. The secondary~     aim of this study was to determine the analgesic efficacy of bupivacaine-clonidine- fentanyl~     combination in comparison to bupivacaine- clonidine- meperdine combination.~   "
70968|NCT02128438|"~     In general , the diagnosis of back pain can be broken into three major categories:~     Mechanical ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor~     , Infection , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic~     disorders , neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by~     mechanical factors, it is the other 2% caused by malignancy, infection, visceral diseases~     and other red herrings that must be considered most seriously.~      The investigators have observed in their practice that lateral pressure on 5th lumbar~     vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over~     cervicothoracic spines reproduce original low back and leg pain. So the question arises~     whether Cervico-thoracic dysfunction is associated with low back pain with or without~     radiation to lower extremities?~   "
70969|NCT02128425|"~     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic~     agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional~     chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic~     colorectal cancer patients.~      A second primary aim is to evaluate the response rate, safety and tolerability of the~     chemotherapy of FOLFOXIRI regimen in this patient population.~      Patients will be randomized to two therapy groups:~      Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX~   "
70970|NCT02128412|"~     Stent placement is now widely accepted to improve the results of angioplasty (an operation~     to widen the blood vessel) and decreasing the need for further surgery. Despite their~     worldwide acceptance, stent usage is still limited by renarrowing which occurs within the~     stent (restenosis) in some patients within the first six months. In addition there still~     exists a small risk of heart attacks soon after the stent is placed.~      The purpose of this study is to test the safety and tolerability of trying to place the~     stents using a different strategy of using low pressure oversized balloon inflations as~     opposed to the usual high pressure balloon inflations. This may reduce injury to the artery~     and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and~     effective way of performing the procedure the investigators intend to use an Intravascular~     ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to~     be the best way of ensuring optimal stent placement.~      Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of~     oversized stenting at normal inflation pressures ( < 10 atmospheres ) as compared to high~     pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging.~      Secondary Hypothesis: There will be no difference in acute clinical endpoints (death,~     myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of~     oversized stenting at normal inflation pressure as compared to high pressure inflation.~      Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand~     the study in order to reveal a decrease in stent restenosis using a strategy of lower~     pressure balloon inflations. The investigators will assess the deployment characteristics of~     drug eluting versus bare metal stents~   "
70971|NCT02128399|"~     Antimicrobial exposure is known to reduce the selection for various drug-resistant~     organisms. Numerous studies have demonstrated the association between antimicrobial use and~     MDR bacteria detection. However, to the investigators knowledge, there is few data to~     support the concept that reducing antibiotic use actually leads to improvements in~     antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce~     MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial~     overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's~     Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To~     date, the investigators do not have published documentation the effects of this policy on~     multidrug-resistant organism (MDRO) in critically ill patients.~   "
70972|NCT02128386|"~     The purpose of this study is to estimate the proportion of patients with true resistance~     among patients referred to the Medical Outpatient Department of the Charité -~     Universitätsmedizin Berlin with the diagnosis resistant hypertension. Moreover, data on~     medication adherence will be collected based on therapeutic drug monitoring and on the~     answers to validated questionnaires. Finally, efficacy, safety and costs of renal~     sympathetic denervation will be compared to an intensified drug treatment in an exploratory~     way.~   "
70973|NCT02128373|"~     This pilot clinical trial studies the feasibility and effectiveness of a new computer-based~     communication intervention in supporting distance caregivers of patients with advanced lung~     or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any,~     professional support and have limited communication with the oncology team. Using a~     computer-based communication intervention to allow distance caregivers the opportunity to~     participate in a physician visit, have questions and concerns addressed, and meet members of~     the oncology team may help reduce stress.~   "
70974|NCT02128360|"~     The purpose of this study is to determine whether minimal ovarian stimulation for in vitro~     fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos~     as well as pregnancy rates will be compared.~   "
70997|NCT02128061|"~     The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous~     Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in~     patients aged 80 years old or more with not previously treated cluster of differentiation~     antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall~     survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination~     of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP~     regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS~     in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).~   "
70975|NCT02128347|"~     Home dialysis has many potential benefits compared to in-center hemodialysis including~     improved quality of life, reduced hospital admission and reduced cost. However, some~     patients perceive that home modalities are associated with increased isolation from the~     healthcare system, substandard care or higher risk of catastrophic events. Providing better~     support for home dialysis patients may enhance their ability to maintain at home, improve~     their health outcomes, increase quality of life and improve satisfaction with care. In other~     chronic disease populations a secure, online communication portal between physicians and~     patients has proven useful in enhancing care for patients. Thus far, the utility of an~     online portal communication system has not been tested in a cohort of home dialysis~     patients. The investigators hypothesize that this novel form of communication will improve~     care and outcomes for home dialysis patients. Therefore, in a cohort of home dialysis~     patients, the purposes of this study are as follows: 1) Does an online patient-portal~     improve patient satisfaction with home dialysis care? 2) Does an online patient-portal~     improve quality of life? 3) Does an online patient-portal reduce hospitalization and health~     service utilization?~   "
70976|NCT02128334|"~     Eligard is a 6-month depot injection formulation that combines the active ingredient~     leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The~     6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown~     to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated~     in several clinical trials. However, clinical trials are limited by strict patient inclusion~     and exclusion criteria. Therefore, the current non-interventional study aimed at~     investigating whether the efficacy and tolerability of the 6-month LA depot formulation~     could also be confirmed in a broad and heterogeneous patient population encountered in daily~     clinical practice in the Russian Federation.~      This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of~     patients, demographic patient data, diagnosis and diagnostic findings in patients. It will~     provide analysis in different subgroups of patients depending on previous hormonal treatment~     and anamnesis of disease.~   "
70977|NCT02128321|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of Repaglinide and possible metabolites after single dose administration.~     In addition, this study will assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of caffeine and possible metabolites after single dose administration.~     Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in~     combination with caffeine will be assessed.~   "
70978|NCT02128308|"~     This study aims to investigate the pharmacokinetic characteristics of second-line~     anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.~   "
70979|NCT02128295|"~     This is a randomised trial of two modern single electric breast pumps allocated to mothers~     who are exclusively breast feeding their healthy term infants. Mothers will be recruited~     when their infants are around a month old, they will be randomised either to use one of two~     state of the art modern single electric breast pumps or to act as controls with no breast~     pump (but will receive a baby care voucher of similar value). If allocated to a breast pump,~     mothers will be asked to take part in a physiological study when their babies are 6 weeks~     old. In this test the mothers will be asked to express breast milk for 10 minutes on each~     breast. The primary hypothesis is that the total weight of milk produced in a 20 minute~     period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater~     for mothers using one of the pumps. A small sample of breast milk (~5ml) will be collected~     for analysis, the remaining expressed milk will returned to the mother.~      Each month between the age of 3 and 6 months, all the mothers will be asked to complete~     online questionnaires about their breast-feeding and the use of their breast pumps (if they~     have one). At the end of the six months the mothers will be given a small voucher for a~     child-care store as a way of saying 'thank-you' for the inconvenience caused.~   "
70980|NCT02128282|"~     This study considers the safety and tolerability of increasing doses of CX-4945 in~     combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD),~     followed by a randomized study that compares antitumor activity in cholangiocarcinoma~     patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the~     combination MTD with gemcitabine plus cisplatin.~   "
70981|NCT02128269|"~     The primary purpose of this study is to evaluate the safety and tolerability of intravenous~     (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of~     the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or~     thrombocytopenia.~   "
70982|NCT02128256|"~     The surgical management of long bone infections is often challenging. Adequate surgical~     debridement decreases the bacterial load, removes dead tissues, and gives a chance for the~     host immune system and antibiotics to arrest infection. Adequate debridement may leave a~     large bony defect. An appropriate management of the dead space is essential to arrest the~     disease, and for maintenance of the bone's integrity. The current strategy includes the use~     of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the~     dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous~     graft harvested from the hip of the patient.~      CERAMENT™| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium~     sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system~     and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent~     colonization of gentamicin-sensible microorganisms in order to protect bone healing.~      The aim of this study is to investigate the device absorption and bone in-growth of~     CERAMENT™| G in a surgically revised bone infection. In addition, bone healing and infection~     non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a~     treatment success of >90 % and that a similar bone healing will be obtained as with a~     standard two-stage surgical procedure. In addition, the investigators believe that the use~     of CERAMENT™| G will be of advantage for the patient as bone healing will be achieved with a~     one-stage surgical procedure (in combination with antibiotic therapy), instead of a~     two-stage procedure, thus decreasing potential surgery-related complications.~   "
70983|NCT02128243|"~     The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of~     chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in~     terms of overall survival.~   "
70985|NCT02128217|"~     People who are recently infected with HCV have a great chance of being cured of the~     infection when they are treated with a combination of two drugs within the first 6 months of~     being infected. This study is being done to see if a combination of two new drugs in one~     pill can replace the old drugs to provide a safer, more effective, and better tolerated~     treatment for new HCV infection. The names of the new drugs are ledipasvir (LDV) and~     sofosbuvir (SOF), and they will replace pegylated-interferon alfa (PEG-IFN, a drug given as~     a weekly injection under the skin). The fixed-dose combination of LDV and SOF (LDV/SOF) has~     been approved by the Food and Drug Administration (FDA).~      This study started with participants in Group 1 receiving SOF in combination with RBV, a~     drug also approved by the FDA, for 12 weeks. There were a total of 17 participants in Group~     1 and all completed treatment. All participants were monitored for safety and viral response~     while on treatment. After completing treatment, all participants were evaluated for a~     treatment response after the end of treatment.~      If the treatment response in Group 1 was high enough, the study design allowed for the~     possibility to decrease the length of therapy for Group 2 to 8 weeks, using the same~     treatment. However, this did not occur. Combined with the fact that a new and more effective~     treatment for chronic HCV has been approved since the study started, Group 2 will now~     receive 8 weeks of LDV/SOF instead of 12 or 8 weeks of SOF with RBV.~   "
70986|NCT02128204|"~     The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre~     study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital~     Institutional Review Board. The aim of this post-marketing study is to evaluate the safety~     and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.~      The study was estimated to be held half to one year including a 0-2 weeks screening period,~     a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be~     obtained before volunteers enter screening period. If the volunteers meet all the criteria,~     they will be given a number to replace their name in the study. The participants will be~     randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial~     folds and control treatment, Hya-Dermis, in the other side of the face. The safety~     assessment evaluated any recorded adverse events following the device treatments either by~     blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed~     by using photographic assessment, nasoalabial folds severity scale, global aesthetic~     improvement scale, and pain visual analog scale.~   "
70987|NCT02128191|"~     The purpose of this study is to evaluate the efficacy and safety of no treatment compared~     with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study~     hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm~     infants. (non-inferiority study)~   "
70988|NCT02128178|"~     Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high~     risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a~     consensus does not exist on the most effective prophylactic approach.~   "
70989|NCT02128165|"~     The aim of this study is to compare the efficacy of gastric balloon in weight reduction~     among two different categories of morbidly obese people.~   "
70990|NCT02128152|"~     The purpose of this study is to assess the safety and effectiveness of the Ekso robotic~     exoskeleton in persons affected by a severe stroke.~        -  Primary Objectives:~             -  To determine if a structured high-dosage exoskeleton training program (EXTP)~               results in clinically significant gains in walking recovery in individuals~               affected by severe stroke.~             -  To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and~               severity (non-ambulators vs. limited house-hold ambulators) affects the~               improvement in gait speed and overall function following the EXTP training~               protocol.~             -  To determine whether maintenance or further improvement in gait speed can be~               achieved by an intensive follow-up program of either a traditional rehabilitation~               program (TRP) or extended EXTP.~        -  Secondary Objectives:~             -  To determine the effect on functional walking endurance as assessed by the 6~               minute walk test and 10 meter walk test, in high-dosage exoskeleton training~               program (EXTP) vs. traditional rehabilitation program (TRP) carried in an~               outpatient setting for post stroke individuals.~             -  To determine the effect on functional balance, as assessed by the Berg Balance~               Scale, Functional Gait Assessment and Five times sit to stand measure as assessed~               by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs.~               traditional rehabilitation program (TRP) carried in an outpatient setting for post~               stroke individuals.~             -  To determine the effect on stroke recovery, as assessed by the step counter of~               task specific training in high-dosage exoskeleton training program (EXTP) vs.~               traditional rehabilitation program (TRP) carried in an outpatient setting~   "
70991|NCT02128139|"~     Introduction. Comprehensive data on infective endocarditis in developing countries are~     scarce.~      Objectives: Description of the characteristics (clinical and microbiological) and assessment~     of the outcomes of infective endocarditis in low-income countries.~      Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged~     over 1 year fulfilling the modified Duke criteria for infective endocarditis.~      Exclusion criteria: patient included during a previous infective endocarditis episode.~      Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access~     to antibiotic treatment (modalities and duration), hospital length of stay and reason for~     discharge, and cardiac surgery when indicated.~      Duration: One year (June 2014- June 2015)~   "
70992|NCT02128126|"~     The purpose of the study is to assess the safety, tolerability and the HPV-specific immune~     responses of different doses of ISA101 vaccine with or without pegylated IFNα as combination~     therapy with carboplatin and paclitaxel.~      To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b~     vaccine compared to ISA101 at the same dose levels.~      To assess the safety and the HPV-specific immune responses of ISA101b vaccine with~     carboplatin, paclitaxel with or without bevacizumab.~   "
70993|NCT02128113|"~     This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408)~     ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract~     surgery.~   "
70994|NCT02128100|"~     This study wants to find out how safe and effective the use of Folfirinox combined with~     Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.~   "
70995|NCT02128087|"~     In this project the investigators develop and test a short message service (SMS)~     intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding~     Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their~     medications and offers social support via weekly text messages. The investigators propose to~     adapt their previous successful SMS-intervention to the specific needs of youths and to~     evaluate the relative effectiveness of one-way versus two-way text messages (where two-way~     messages allow youths to respond to messages and we hypothesize that this may increase~     perceived social support that may be important for youth populations). We will also test the~     effectiveness of SMS messages over the longer-term (2 years), for which currently no~     information is available.~   "
72474|NCT02108730|"~     Observational study in patients with non-focal congenital hyperinsulinism showing that~     restrictive surgery may improve the metabolic situation~   "
70998|NCT02128048|"~     Tobacco smoke is probably the single most significant source of toxic chemicals that humans~     are exposed to. Smoking is associated with a variety of pathological conditions such as~     cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette~     smoking, several epidemiological studies identified tobacco use as a risk factor for~     sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous~     studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and~     found structural and metabolic damage in muscles of smokers.~      Quitting of smoking is known to be associated with weight gain. A previous study examined~     the effects of smoking cessation on body composition of post-menopausal women using~     dual-energy x-ray absorptiometry (DEXA). It was found that women who successfully quit~     smoking for a period of 16 months have significantly increased their body weight, fat mass,~     muscle mass and functional muscle mass in comparison with non-quitters women. For the first~     time, it was shown that smoking cessation is associated with an increase of functional~     muscle mass. Yet, the effects of quitting of smoking on muscle mass and muscle functional~     capabilities of younger subjects remain unclear. Therefore, we aim to investigate the~     effects of smoking cessation on muscle mass, muscle function and strength in heavy smoker's~     subjects. Our findings may shed light on the beneficial effects of smoking cessation~     regarding the status and function of skeletal muscle in heavy smokers and as a possible~     strategy to prevent or delay the progression of sarcopenia.~      Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in~     skeletal muscle mass and improvement of muscle function and strength compared with continued~     smokers.~   "
70999|NCT02128035|"~     RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary~     angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who~     will perform the procedure will wear a radiation protection cap in all procedures.~      It is hypothesized that routine use of the pelvic lead shield and radiation protection cap~     during these procedures will reduce the amount of radiation in which the interventional~     cardiologists get exposed.~   "
71000|NCT02128022|"~     Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1~     (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply~     (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with~     ischaemic conditioning of the heart, which is dependent on potassium channel opening.~      The investigators intend to establish whether GLP-1 mediated protection shares a similar~     mechanistic pathway. In order to do this the investigators will measures pressure--volume~     loops generated in the main pumping chamber of the heart at the time of a percutaneous~     coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with~     glibenclamide (a potassium channel blocking medication approved for human use), saline~     control or glibenclamide alone.~      The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of~     glibenclamide.~   "
71001|NCT02128009|"~     The miRNA plays an important regulation role in gene expression, and also closely related to~     bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin~     deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by~     bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual~     luciferase report system for target validation, aimed at the miRNA levels to explore~     postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.~   "
71002|NCT02127996|"~     Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty~     and stenting is performed for people with angina to improve the blood supply to the heart by~     placing metal tubes within the artery using balloon inflation. The procedure risks small but~     significant damage to the heart muscle downstream of the balloon.~      Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the~     gut in response to food. It acts by stimulating the release of insulin. In the heart it acts~     to increase glucose uptake into cardiac muscle. GLP−1 can protect the heart and improve~     heart muscle performance in people with coronary artery disease in physiological studies.~     This study which assesses whether GLP−1 protects the heart during coronary angioplasty and~     stenting.~      The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will~     reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.~   "
71003|NCT02127983|"~     The intervention consisted of training non-paid informal healthcare providers (such as~     store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to~     the public health system, and raising community awareness. Front line public health~     personnel and community leaders were sensitised to support the intervention.~   "
71004|NCT02127970|"~     To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment~     with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in~     patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin~     structure infections) at 48 -72 hours after initiation of treatment.~   "
71005|NCT02127957|"~     The objective of the investigators research program is to determine whether a combined~     exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes~     control in CF patients. This program of exercises to increase strength and muscle endurance,~     exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose~     tolerance. The effect of exercise will be compared with a control group of 12 patients also~     glucose intolerant but do not participate in structured physical activity program. The~     duration of the exercise program will be 12 weeks and several measures (glucose tolerance,~     inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will~     be conducted pre and post program to assess the program's impact .~   "
71006|NCT02127944|"~     IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING~     HIGH-SENSITIVE TESTS.~   "
71018|NCT02127788|"~     The purpose of this observational study is to describe the actual conditions of prescription~     of micafungin in antifungal prophylaxis in French haematological and onco-haematological~     units. The efficacy and the safety outcomes will be described.~   "
71019|NCT02127775|"~     This study will assess the bioequivalence of lesinurad tablets manufactured at two different~     sites.~   "
72542|NCT02107807|"~     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18~     through 60 years of age) and elderly (≥61 years of age) subjects with and without~     immunosuppressive conditions.~   "
71007|NCT02127931|"~     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and~     provide little information about accessory movements in response to a stimulus.~      Tests such as the Conners' Rating Scale require subjective responses from parents and~     teachers, making coordination difficult. The computerized Conners' Continuous Performance~     Test (CPT) provides objective data in regards to inattention and impulsive patterns of~     response. However, it does not provide data regarding accessory movements such as~     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the~     exam has a reading disorder, it will impair his or her ability to respond accurately and it~     will increase response time. The T.O.V.A. is another computer based test used as a~     diagnostic aid for ADHD, which uses a microswitch to record responses. It does utilize~     auditory and visual stimuli, which removes the reading level limitation. However, it is~     unable to measure to measure accessory movements that may be contributing to reaction time~     and errors of omission and commission.~      Because of these limitations, a new company called CogCubed has created a new game based on~     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are~     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact~     with one another. CogCubed is providing the data for this study. The game will be played in~     a 30 minute sessions by subjects aged 18 and over. Subjects recruited to play the game will~     be those with ADHD and those without, matched by gender. Those with comorbidities of~     developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and~     substance use disorders will be excluded, as well as any physiological disability that~     affects upper limb movement and/or coordination. Informed consent will be obtained from~     participant prior to administering the game.~      The hypothesis is that by analyzing data generated from this new gaming platform named~     Sifteo for which a game was created, which uses auditory and visual stimuli and distracters,~     the investigators expect that they will be able to provide a more accurate profile of~     impulsivity and inattention. The investigators expect that inattention will have more errors~     of omission and less tilt movements than control and impulsivity will be represented as more~     commission and greater tilting movements than control.~   "
71008|NCT02127918|"~     Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the~     electroencephalogram (EEG). Children who have this pattern present seizures and~     neuropsychological regression. There are no studies that systematically evaluate the~     response of abnormal discharges in the EEG, seizures and neuropsychological regression to~     different antiepileptic treatments. Therefore, treatment strategies in ESES are not based on~     scientific evidence. High-dose benzodiazepines such as diazepam (valium) have been reported~     to improve the severe EEG abnormalities of patients with ESES in the short-term. But the~     long-term response of seizures and neuropsychological regression has not been systematically~     studied. Clobazam is a benzodiazepine derivative with antiepileptic properties. The~     pharmacologic properties of clobazam make of this drug a particularly useful option in ESES:~     in patients with ESES the alpha-2 subunit of the GABA receptor is preferentially~     up-regulated and clobazam may have a higher affinity for this particular subunit, so~     investigators expect a higher effect of this drug on ESES patients than with other~     benzodiazepines (Loddenkemper et al, in preparation). The aim of our study is to objectively~     evaluate the response to clobazam treatment of neuropsychological deficits, seizures and~     abnormal discharges in the EEG in patients with ESES. Clobazam treatment is used in routine~     clinical practice and investigators will objectively quantify its effect.~      Our working hypothesis is that high-dose clobazam treatment may control the abnormal~     epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal~     epileptiform discharges may lead to an improvement in neuropsychological deficits and~     seizures. The predicted improvement in seizures and neuropsychological function would lead~     to a better quality of life in these patients.~   "
71009|NCT02127905|"~     The protocol is designed for the compassionate treatment of patients with Fanconi Anemia who~     do not have an HLA-matched sibling donor. The purpose of this study is to determine the~     likelihood of engraftment in Fanconi Anemia patients using total body irradiation (TBI),~     cyclophosphamide (CY), fludarabine (FLU) and antithymocyte globulin (ATG) followed by an~     unrelated donor hematopoietic cell transplant with T-cell depletion using the CliniMACS~     device.~   "
71010|NCT02127892|"~     This is a pilot clinical trial of hematopoietic stem cell transplantation for patients with~     a diagnosis of Severe Combined Immune Deficiency (SCID) who do not have an HLA-matched~     sibling donor. The stem cells will be derived from a 1) matched unrelated donor (MUD), 2)~     unrelated cord blood donor, or 3) a haplo-identical (parental) donor (in descending order of~     preference).Patients will receive a novel conditioning regimen with Busulfan, Fludarabine~     and Anti-thymocyte globulin (ATG) followed by an unrelated donor hematopoietic stem cell~     transplant (HSCT) with T-cell depletion using the CliniMACS device.~   "
71011|NCT02127879|"~     The main purpose of this study is to determine whether intensive repetitive transcranial~     magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in~     schizophrenia patients and whether it has a positive influence on their cognitive functions,~     social functions, quality of life, alpha frequency and cortical silent period changes. Also,~     this study should provide data about safety and tolerability this I-rTMS treatment in~     schizophrenia patients.~   "
71012|NCT02127866|"~     The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate~     bromide) on top of Foster which provides the optimal additive bronchodilator effect to~     asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled~     corticosteroids plus long acting beta2 agonists.~   "
71013|NCT02127853|"~     Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial,~     bilateral cataract surgery.~   "
71014|NCT02127840|"~     The project is aimed to determine the value of synacthen infusion on the results of adrenal~     venous sampling in patients examined for primary aldosteronism~   "
71015|NCT02127827|"~     Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The~     insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can~     approximate the insulin release patterns of the normal pancreas. Timely and accurate~     knowledge of ambient glucose levels is important for insulin dose adjustments. Typically,~     glucose values are measured volitionally, several times a day, using capillary fingerstick~     samples. In addition, glucose in the interstitial fluid can be measured automatically and~     continuously using implantable glucose oxidase-based sensors. Recent study showed that this~     continuous measurement of glucose levels allows for a fully automated closed-loop insulin~     replacement therapy which requires an algorithm that receives glucose data, calculates an~     appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for~     development of a closed-loop insulin replacement system that integrates insulin delivery,~     glucose measurement, and control subsystems will present several challenges to biomedical~     engineers.~   "
71016|NCT02127814|"~     The purpose of this study is to find whether Lactobacillus reuteri prevents~     antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will~     be admitted from the University Hospitals Case Medical Center. They will be randomly~     assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will~     occur during antibiotic treatment and for an additional 7 days after cessation of treatment.~     Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic~     cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances.~     Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence~     of other GI symptoms.~   "
71017|NCT02127801|"~     The purposes of this study are to assess the efficacy, safety and tolerability of a single~     dose of REGN1908-1909 in allergic adult participants, to collect information about how much~     REGN1908-1909 is in blood over time and to collect information about how the body reacts to~     REGN1908-1909.~   "
71020|NCT02127762|"~     By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2~     diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of~     diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases~     with patient age and duration of disease and it can be as high as 60 to 70% in older~     cohorts. Diabetic peripheral neuropathy is documented in most studies as numbness, tingling,~     pain and/or objective sensory changes. Pain is an early manifestation of neuropathy and may~     be the presenting symptom of diabetes. Even the best medications and procedures rarely~     relieve more than 30% of the discomfort of chronic painful conditions. Diabetic patients~     continue to experience debilitating and disabling pain. Pain affects our ability to work,~     our ability to participate in recreational activities, our mood and our relationships. It is~     well-established that an interdisciplinary approach is key to the treatment of some types of~     chronic pain, but little research has been done on the effectiveness of interdisciplinary~     treatments for patients suffering from painful diabetic peripheral neuropathy. The~     investigators will evaluate the effectiveness of an interdisciplinary approach combining~     medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and~     improve quality of life among patients with painful diabetic peripheral neuropathy. The~     investigators will also evaluate the impact of the program on psychological distress, pain~     cognitions, and biomarkers of stress and glycemic function.~   "
71021|NCT02127749|"~     The purpose of this study is to determine whether treatment with antibiotics, which harm the~     gut flora, causes the immune system to be less effective.~   "
71022|NCT02127736|"~     The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep~     patterns can be conditioned according to learning theory in healthy participants.~   "
71023|NCT02127723|"~     The most common treatments today for enhancing the shape and size of the buttocks are~     transplantation of the patient's own body fat after liposuction and insertion of permanent~     implants. Macrolane VRF30 is a gel product based on hyaluronic acid which is a transparent~     slow-flowing gel. A similar hyaluronic-acid gel from the same manufacturer, Q-Med AB, has~     been used for many years for the treatment of facial wrinkles. By injecting Macrolane gel~     into the skin, the shape of the buttocks can be altered and their volume increased.~   "
71024|NCT02127710|"~     This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate~     the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC)~     who are treatment naïve or previously treated.~      An independent central pathology review of tumour samples will be used to confirm the~     diagnosis of PRCC of all patients enrolling. However, locally available pathology results~     confirming PRCC will be allowed for timely study entry.~   "
71025|NCT02127697|"~     The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in~     patients with poorly controlled asthma over 52 weeks of treatment.~   "
71026|NCT02127684|"~     The investigators would like to investigate the efficacy of more frequent treatment with~     Lucentis for subjects with persistent diabetic macular edema despite standard dosing~     regimen.~   "
71027|NCT02127671|"~     This study will determine whether a program where a health coach works with participants on~     heart healthy behaviors and treatment of risk factors is coordinated with primary care can~     reduce overall heart disease risk in people with serious mental illness.~   "
71028|NCT02127658|"~     In this study, the investigators intend to compare therapies (abscess surgery and hygiene~     education compared to abscess surgery and hygiene education followed by decolonization) for~     Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to~     determine which is the more effective treatment. The investigators focus on patient centered~     outcomes as described by the families of MRSA infected patients. Such outcomes are likely to~     include quality of life, side effects, and school and work attendance. The hypothesis is~     that treatment with decolonization will decrease the rate of SSTI recurrence and improve~     overall patient centered outcomes. The rationale is that negative outcomes such as~     recurrence may be avoided through the use of readily available prevention strategies, but~     that it is important to determine how burdensome those prevention strategies are for~     patients and families.~   "
71029|NCT02127645|"~     Objective: Recent randomized and non-randomized studies suggest that neoadjuvant~     radiotherapy followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to~     abdominal resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is~     significant already for T1 invasive cancers with submucosa infiltration >1 mm it is our~     intention to investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of~     this combined treatment in a case series comparing results of this pilot study to an~     historical series of patients affected by T1-T2 rectal cancer who underwent anterior~     resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal~     resection (APR) with no neoadjuvant therapy.~      If equally effective, TEM offers a further reduction in invasiveness of treatment, which~     should correspond to a lower morbidity, mortality and a better quality of life.~   "
71030|NCT02127632|"~     Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of~     pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single~     use device and the presence of a drain tube allows to separate the gastrointestinal and~     respiratory tracts. We planned to compare ventilation parameters and gastric distension~     scores of with LM-S vs ETT during laparoscopic gynecological surgery.~   "
71031|NCT02127619|"~     The purpose of this study was to assess the results of a Total Knee prosthesis specifically~     intended to enhance functional performance , especially in terms of physical and sports~     activity.~   "
71032|NCT02127606|"~     Extended periods of tilt table standing have been observed to improve spasticity in~     individuals with spinal cord injury (SCI). The purpose of this study is to determine the~     effect of three sessions of whole body vibration while tilt table standing on spasticity in~     individuals with a complete or incomplete SCI above the neurological level of T10.~     Participants in this study will undergo whole body vibration while standing on a tilt table~     for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days.~     Spasticity monitoring will be evaluated prior to and after the intervention with the~     Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and~     impression of the effect of whole body vibration on the performance of activities of daily~     living, quality of life, pain scale, and global impression of change.~   "
71034|NCT02127580|"~     There is limited experience for the balloon expandable THV (transcatheter heart valve) on~     the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify~     results of a small case series published by Wendler et. al. to examine hard endpoints such~     as the incidence of cerebrovascular complications, paravalvular leakage and operative~     outcomes in a multicenter registry.~      We aim to compare the implantation of balloon expandable transcatheter heart valves with or~     without predilation with respect to procedural outcomes (VARC2).~   "
71035|NCT02127567|"~     Introduction: Inadequate reporting is a frequent cause of waste of research. For example,~     essential information for evaluating the risk of bias such as the method of randomization is~     lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do~     not provide sufficient details to allow replication of the treatment evaluated in the trial~     in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based,~     minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines~     have since been updated in 2001 and more recently in 2010. In addition, extensions to the~     main CONSORT statement have been developed to give additional guidance for RCTs with~     specific designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic~     treatments). Many journals endorse the CONSORT statement. Some journals provide~     recommendations to authors to follow the CONSORT guidelines and some editors enforce the use~     of the CONSORT guidelines by requesting authors to submit a checklist in either the~     submission or acceptance stage. Nevertheless, inadequate reporting remains.~      Our objective is to evaluate the impact of the CONSORT based online writing tool on the~     completeness of reporting.~   "
71036|NCT02127554|"~     The aim of this study is to find the most agreeable and in the long term most efficient~     treatment for epistaxis.~   "
71037|NCT02127541|"~     Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only~     curative approach is the surgical excision. The preoperative detection remains a challenge.~     A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in~     the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor~     (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT;~     SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting~     GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in~     patients so far.~      Beta cell mass (BCM): The in vivo determination of BCM is currently impossible due to the~     lack of a reliable tool. Quantitative assessment of BCM in vivo is of enormous interest for~     patients with type 1 (T1D) and type 2 diabetes mellitus (T2D) in order to evaluate~     pathophysiological mechanisms of T1D and T2D and potential therapeutical interventions~     aiming at the prevention of autoimmune beta cell destruction (i.e. in T1D before clinical~     diagnosis or after islets transplantation) or preservation of BCM in T2D. Radionuclide-based~     methodology (GLP-1R imaging using) radioligands that directly target beta cells appears~     particularly promising.~   "
71038|NCT02127528|"~     this study aims to verify the adequacy of doses of antibiotics prescribed in clinical~     practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit~     (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact~     of these pharmacodynamic parameters on the clinical and microbiological VAP will be~     evaluated.~   "
71039|NCT02127515|"~     This is a randomized controlled trial in women at risk following combined prenatal screening~     for Down Syndrome. Women will be asked about their preferences between NIPT and routine~     prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between~     NIPT and standard invasive prenatal diagnosis.~   "
71040|NCT02127502|"~     The investigators seek to evaluate a new test for determining presence of infection/sepsis~     as compared to non-infection/systemic inflammatory response syndrome among critically ill~     patients within the first 24 hours of their being hospitalized in an intensive care unit~     (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to~     validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2)~     an existing blood test, procalcitonin. The investigators also hope to assess how well a~     related, new blood test, SeptID® identifies different types of infection, as compared to~     cultures and other lab tests.~   "
71041|NCT02127489|"~     This study aimed to compare the efficiency of rectal midazolam addition after applying~     bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional~     analgesics, postoperative recovery, sedation, and to find out its adverse effects in~     children having lower abdominal surgery.~   "
71042|NCT02127476|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's~     Disease (AD) or Mild to Moderate AD.~   "
71043|NCT02127463|"~     This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye~     of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD)~     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2~     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for~     these patients.~      An analysis of the primary and secondary endpoints will be conducted when all subjects have~     completed Baseline, 1, 3, 6, 12,18 and 24 months.~   "
71044|NCT02127450|"~     The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging~     concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production~     are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or~     proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in~     the routine in any laboratory is difficult. it will be useful to standardize them detection~     to control the emergence.~   "
71045|NCT02127437|"~     LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized~     double blind placebo controlled study. The main objective is to prove that lanreotide, a~     somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years~     by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are~     among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled~     to start in early 2014.~      An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to~     60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30~     ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by~     repeated measures, in the overall population as well as in the two GFR stratus.~   "
71046|NCT02127424|"~     To reduce late HIV diagnosis that remains common in France, the national health agency has~     promoted non-targeted HIV screening in health care settings, including emergency departments~     (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was~     feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at~     high-risk. Our findings, consistent with results from other international groups, suggest~     that a targeted strategy could be feasible, efficient and cost-effective with fewer tests~     required. However, the feasibility and the efficacy of this strategy remain unknown in~     France.~      The main aim of the present study is to compare the efficacy of 2 strategies: 1) the~     combination of the nurse-driven HIV targeted screening and the current practice~     (physician-directed HIV diagnostic testing) versus 2) the current practice alone.~      The strategies will be compared during 2 randomly assigned periods (cluster randomization~     and cross-over) in 8 EDs of metropolitan Paris.~      During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years~     old, identified as high-risk by a self-administered questionnaire, not know to be HIV~     positive, not being seen for post-exposure prophylaxis or unstable medical illness, and~     accepting to participate by providing an informed consent.~      In case of confirmed reactive rapid test result, a follow-up visit with an on-site~     infectious disease specialist will be arranged within the following 48 hours.~   "
71047|NCT02127411|"~     Benzodiazepines (BZD) are the most prescribed psychiatric drugs in Brazil, especially for~     women. Although it is recommended that the use of BZD is not greater than four weeks, there~     are many cases of prolonged use due to the lack of treatment options for dealing with~     complaints of insomnia. Given this, the aim of this project is to evaluate the program~     Mindfulness-Based Relapse Prevention (MBRP) for adult women with chronic use of~     benzodiazepine (BZD) to induce sleep. Specifically aims to evaluate if the MBRP program, can~     reduce the pattern of use and level of dependence of chronic users of BZD under gradual~     reduction (tapering) or cessation of the use of BZD. This study will be conducted at the~     Drug Dependency Unit (UDED) of the Department of Psychobiology of Federal University of São~     Paulo. The study will count with two groups: intervention group (IG) and control group (CG)~     (that will stay in the waitlist until the eighth month . The sample will comprise 100 women~     with chronic use of BZD as hypnotics, 50 will be randomized in the IG condition and 50 in~     the CG condition. Changes will be evaluated on several variables such as cessation and~     dependence of BZD, quality of life, sleep, anxiety, depression and sexual satisfaction~     before and after the intervention in both groups. The data will be submitted to descriptive~     and inferential bivariate and multivariate statistic analyzes. It is hoped that this study~     create subsidies for the development of complementary interventions for the management of~     withdrawal symptoms in chronic users of BZD.~   "
71048|NCT02127398|"~     It has been shown that restoration of the normal makeup of the bowel bacterial population is~     the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration~     of the normal bowel bacterial population is best done by transplanting stool from a healthy~     donor. The investigators wish to transplant stool from healthy donors to treat recurrent C.~     difficile colitis by incorporating the stool into capsules that are administered by the oral~     route.~   "
71049|NCT02127385|"~     Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin~     (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti~     oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease~     oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp~     2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp~     2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more~     common and severe in the Hp 2-2 genotype with the less anti oxidant properties.~   "
71050|NCT02127372|"~     This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for~     treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).~      This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation.~     Not all subjects enrolled into this phase of the study will receive the same dose. The~     purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be~     used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.~   "
71051|NCT02127359|"~     Cancers occur when the molecules that control normal cell growth (genes and proteins) are~     altered. Changes in the tumor genes and in the genes of normal cells are called~     alterations. Many of these alterations can be detected by directly examining cancer cells~     in a tumor or circulating in blood. Several alterations that occur repeatedly in certain~     types of cancers have already been identified. These discoveries ahve led to the development~     of new drugs that target those alterations. More remain to be discovered.~      Some of the alterations are found in genes. Genes are composed of DNA letters, which~     contain the instructions that tell the cells in our bodies how to grow and work. Genes make~     proteins which actually carry out the instructions in our cells.~      We would like to use your DNA to look for alterations in the genes in cancer cells and blood~     cells using a technology called sequencing. Gene sequencing is a way of reading the DNA to~     identify errors in genes that may contribute to the behavior of cells. Some changes in genes~     occur only in cancer cells. Others occur in normal cels as well, in the genes that may have~     been passed from parent to child. This research study will examine both kinds of genes.~      The purpose of this research study is to perform gene sequencing (gene tests) on your cancer~     cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of~     the gene tests will be used to try to develop better ways to treat and prevent cancers. We~     will also study better ways to communicate the results of these complex gene tests to you~     and your doctors, and to help you and your doctors use this information to choose the best~     paths for treatment. As part of this work, we may also learn things about the genes in your~     normal cells; some of that information will also be shared wtih you and your doctors if you~     so choose.~      Importantly, this study will use tissue specimens that have already been collected and~     stored in the pathology department as part of your clinical care or as part of other~     research studies you may be participating in. In this study, gene tests will be performed on~     material only after the necessary clinical tests have been performed. In general, no~     additional invasive procedures will be required.~   "
71052|NCT02127346|"~     Objective: The objective was to evaluate whether serum vitamin D and calcium concentrations~     are associated with chronic periodontitis in Syrian men Methods: This study designed as~     Matched Case-Control Study.200 males will be enrolled in this study and will be divided~     into two groups. First group consist of 100 patients suffering from chronic periodontitis~     and no systemic diseases. Second group consist of 100 healthy volunteers. Serum vitamin D~     and calcium concentrations will be tested. Periodontal indexes include probing depth (PD),~     clinical attachment level (CAL), and bleeding on probing (BOP) will be taken. Data will be~     collected and analyzed.~   "
71390|NCT02122900|"~     The primary objective of this study is to determine the reasons for balloon aortic~     valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in~     patients with aortic stenosis. The ultimate aim is to establish the safety, effectiveness,~     and appropriate role of BAV therapy as definitive therapy (palliation) or as a bridge to~     surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).~   "
71053|NCT02127333|"~     Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary~     disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for~     vascular function. For this purpose we measure capillary oxygen concentration and vascular.~      Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm~     blood flow and laser doppler perfusion imaging.~      We hypothesize that hypoxemia leads to impaired vascular function.~   "
71054|NCT02127320|"~     The purpose of this study is to investigate the pharmacokinetic drug interactions between~     Rosuvastatin and Ezetimibe in Healthy Male Subjects~   "
71055|NCT02127307|"~     This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to~     identify those subjects with New York Heart Association (NYHA) Class II or III HF who will~     die during 60 months of follow-up from the date of administration of AdreView™ in prior~     studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).~   "
71056|NCT02127294|"~     The purpose of the study is to evaluate effectiveness and safety of transcatheter patent~     foramen ovale closure for migraine.~   "
71057|NCT02127281|"~     The purpose of this study is to determine the efficacy of a negative pressure wound therapy~     (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for~     infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk~     patients prevents wound complications and decreases reoperation rates.~   "
71058|NCT02127268|"~     Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical,~     emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment~     that is not proportion to recent activity and interferes with usual functioning. Compared~     with general fatigue, CRF have the characteristics of long duration and generally cannot~     alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and~     family life, and thus greatly affect the recovery, self-care ability and life quality of~     patients. Many dates showed that 70%~100% of cancer patients experienced cancer-related~     fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent~     years, many clinical trials are carried out; central nervous stimulant, such as~     methylphenidate; acupuncture, aerobic exercise. All those measures may have certain~     therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm.~      Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities~     primarily directed towards immune response enhancement, this drug is used for the treatment~     of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of~     non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma.~     T-α1 is able to potentiate the action of cytokines and also reduce the hematological~     toxicity of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine.~      In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for~     cancer-related fatigue in cancer patients who undergo chemotherapy.~   "
71059|NCT02127255|"~     This is a randomized, controlled cross-over trial. The hypothesis of this study is that the~     differences in manual acupuncture manipulation can impact clinical effect though the~     acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical~     experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients~     receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5~     days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of~     acupoints and methods of needling manipulation, needle retention time). Randomly, half of~     the patients will receive treatments from acupuncturist 1 in the first treatment cycle and~     from acupuncturist 2 in the second cycle; while the other half will be treated in other way~     round. There is a washout period (21 days) between two cycles. The needling manipulation of~     two acupuncturists will be measured objectively during treatments. The clinical effect will~     be measured by the control of vomiting and nausea during and after chemotherapy treatments.~   "
71060|NCT02127242|"~     Objective:the purpose of this study is to investigate the~     efficacy,feasibility,reliability,and safety of laparoscope combined air-pressure ballistic~     lithotripsy in the treatment of patients with bile duct stones.~      Methods:We are going to select 60 patients diagnosed with hepatolithiasis who carry on the~     treatment in our hospital from April 2014 to April 2015.According to the unified inclusion~     and exclusion criteria,the patients are divided into the experimental group and the control~     group.The experimental group use the treatment of laparoscope combine with air-pressure~     ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients~     with hepatolithiasis with the method of lobectomy and segmental resection of~     liver.Contrastive analyzed two group of patients' clinical care effects.~      Research hypothesis:according to compare two groups' duration of surgery,blood~     loss,postoperative complication rate,hospital stay,the stone clearance rate,,the residual~     stone rate,reoperation rate etc.We suppose that the clinical results of the experimental~     group are superior to the control group,difference is statistically significant(P<0.05).So~     we can draw the conclusion that the method of laparoscope combined air-pressure ballistic~     lithotripsy is useful in treatment of patients with hepatolithiasis.~   "
71061|NCT02127229|"~     The purpose of the study is to determine if endoscopist notification of accessory cost~     results in altered resource utilization related to the total cost and number of accessories~     used in ERCP.~      This study will be a prospective cost--analysis study. Only chart review of PHI removed~     records will be used. The only intervention used is that endoscopists will be made aware of~     the cost of accessories used in the second phase of the study following each ERCP.~      The investigators are in an era of increased medical cost consciousness. Medical education~     and post--graduate education incorporates cost savings and appropriate diagnostic test~     selection based on expense as one aspects of the decision process. This era now focuses on~     what is best for the patient with the understanding that the cost to the patient and cost to~     the overall health care system matters. Not only is this apart of postgraduate training but~     now being implemented as part of Medicare reimbursement to provide low cost and high quality~     care. Incidence of pancreatic and biliary disease is increasing. ERCP is a vital tool for~     therapeutic intervention. The costs of these procedures, to both patients and hospitals,~     have caused some to question the amount of accessories used as well as the poor~     reimbursement provided by Medicare and insurers. Studies have indicated that hospitals~     actually lose money with each ERCP used and their use is being limited many times to~     tertiary care centers.~   "
71062|NCT02127216|"~     In 2010, 25.8 million people in the US, or 8.3% of the population were reported to have~     diabetes. Type 2 diabetes mellitus (T2DM) is especially prevalent among older adults: 26.9%~     of people 65 years or older have diabetes with 50% being pre-diabetic. Diabetes is the~     leading cause of blindness, kidney disease and lower-limb amputation among older adults, and~     is also a major risk factor for cardiovascular disease.~      Fortunately, diabetes and its related complications are very amenable to lifestyle changes.~     Engagement with healthcare providers can significantly affects behavior and disease~     management of practices of individuals as does social engagement. The use of mobile~     technology and better engagement with providers and peer support networks may support~     diabetes self-care management. Individual patient personality attributes may affect the~     success of technology interventions.~      In this study, the investigators propose to design and test a motivation psychology-based~     smart engagement system (MOSES), which is a software application on a digital tablet device.~     The pre-loaded tablets will be provided to adults with T2DM (age 60+ with high glucose). The~     software will allow the patients to record diabetes self-care activities (exercise, glucose,~     nutrition, medication adherence), pursue goals, support communication between the patient~     and a health coach, support communication between peer patients, and visualize health status~     more easily by patients and providers. This research program will enroll 88 patients (4~     intervention groups of 12 persons each and a 40-person control group) in a 90-day pilot~     study to test and refine the design of the application and its effectiveness in supporting~     care plan goals.~      Primary Aim 1: Design, implement, and optimize a motivation psychology-based smart~     engagement system (MOSES) for older adults with diabetes.~      Secondary Aim 2: Determine if providing older adult diabetic patients to care managers and~     peers via a digital tablet-based software application leads to improved diabetes management~     as measured by blood glucose control.~      Secondary Aim 3: Refine the personality attributes used to tailor the interaction with the~     application.~   "
71063|NCT02127203|"~     Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully~     understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are~     involved in physiological and pathological processes. Nitro-oxidative stress has been~     implicated in Periodontitis.~      The aim of this study is to assess the levels of ROS and RNS in serum and gingival~     crevicular fluid (GCF) samples taken from periodontitis (chronic and aggressive) patients~     and healthy controls. Subsequently, correlating these levels with the severity of~     periodontal disease.~      Eighty subjects will be invited to participate in this study. Patients will be allocated~     into four groups (20 patients each). The biochemical parameters that will be investigated~     are Malondialdehyde (MDA) (using TBRSA assay) as a marker of oxidative stress and (NO- level~     using Griess reagent) as a marker of nitrosative stress.~   "
71064|NCT02127190|"~     This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is~     to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various~     incremental doses, and to demonstrate the safety and tolerability of the rate of the~     emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic~     (PD) effects of CXA-10 will be investigated.~   "
71065|NCT02127177|"~     The increased risk of atherosclerotic morbidity and mortality in patients with obstructive~     sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and~     systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and~     lipidemia and systemic inflammation is far from conclusion for obesity as a strong~     confounding factor.~   "
71066|NCT02127164|"~     Emergent abdominal surgeries have very high rate of wound contamination due to exposure to~     bacteria from GI tract. There are several different approaches to wound management in these~     patients including wet-to-dry dressing or application vacuum assisted device on the wound.~     The investigators propose using the vacuum assisted device with Dakin's solution on patients~     undergoing emergency surgery for hollow viscus perforation installed immediately at the end~     of operation and remained there for the first 3 postoperative days, followed by delayed~     primary closure on postoperative day 4. The investigators believe this technique can achieve~     earlier wound closure, decrease patient discomfort, improve cost savings, and potentially~     standardize and revolutionize the investigators management of heavily contaminated wounds.~   "
71067|NCT02127151|"~     A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With~     Retrospective PTEN, MSI and MRE11 Analysis~      PTEN= Phosphatase and tensin homolog MSI= Microsatellite instability MRE11= Double-strand~     break repair protein MRE11A~      This trial will investigate whether the drug BMN 673 has therapeutic benefit in the~     treatment of advanced endometrial cancer. Nearly 8,000 patients are diagnosed with~     endometrial cancer in the UK every year. A significant proportion are either diagnosed with~     advanced disease which may be inoperable and/or metastatic (i.e spread to other organs~     outside the endometrium), or curable disease which relapses following first line treatment.~     There is no established standard of care for these patients as both chemo and hormone~     therapy has limited effectiveness and survival benefit. Survival rates have not improved in~     the past 20 years. Furthermore there are no so called 'targeted' drugs licensed for its~     treatment i.e. drugs that block the growth and spread of cancer by interfering with specific~     molecules involved in tumor growth and progression. This leaves an unmet need for effective~     systemic treatments for advanced, inoperable and metastatic endometrial cancer.~      BMN 673 has been shown to be potentially effective in treating cancers known to behave~     similarly to endometrial disease, both in the laboratory and in Phase I studies involving~     patients with advanced cancers. Similarly the drug appears to be relatively tolerable. A~     Phase II trial such as the one proposed by this application could demonstrate activity that~     might lead to a new effective treatment for patients with inoperable, advanced, recurrent or~     metastatic endometrial cancer, while the proposed substudy also presents the possibility of~     discovering a subset of patients more likely to derive benefit from BMN 673.~      This trial is for adult women (18 and above) with advanced, inoperable or metastatic~     endometrial cancer. Patients will be recruited from approximately 15 National Health Service~     (NHS) Trusts based in the United Kingdom (UK). The study is expected to last approximately~     18-24 months in terms of recruitment time, and a maximum of 100 eligible women will be~     registered. All patients will receive BMN 673 until their disease worsens or their doctor~     decides they should stop treatment.~   "
71068|NCT02127138|"~     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active~     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left~     Main Bifurcation Lesions~   "
71069|NCT02127125|"~     The purpose of this study is to determine whether microbiome modulation and an experimental~     reduction in plasma LPS concentration improve inflammation and insulin action in insulin~     resistant (obese and T2DM) subjects.~   "
71070|NCT02127112|"~     This study with compare the ridge dimension changes for a block allograft vs. a~     demineralized bone matrix moldable allograft.~   "
71071|NCT02127099|"~     Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with~     momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow.~     When this happens, the patient will snore, gasp or choke in the attempt to attain more~     oxygen. This results in disrupted sleep and the patient may even awake from sleep.~      It has been found that a great proportion of Malaysians have habitual snoring and with the~     increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia.~      However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry~     because these people can come in for surgery. Diagnosis of OSA before surgery is important~     in order to prepare for the complication related to OSA.~   "
72820|NCT02104167|"~     The purpose of this combined retrospective and prospective clinical study is to examine~     safety and efficacy of the ROI-C® anterior cervical interbody fusion device with~     VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in~     the short term, with a focus on fusion rates.~   "
71072|NCT02127086|"~     The purpose of this project is to test an innovative method for managing pain in acutely ill~     hospitalized patients who are not able to report their pain verbally to health care~     professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative~     (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management~     of medication side effects. The researchers will evaluate whether patients who are managed~     with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain~     management strategies than those who are not managed with the PAIN Algorithm.~      The study design is a non-randomized quasi-experimental cohort design with two cohorts who~     will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG),~     or control cohort, defined as receiving pain assessment and management practices that nurses~     are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with~     analgesic order sets will be introduced to nurses and physicians on all participating units~     as the intervention. Patients enrolled in this phase will be considered the intervention~     group (IG), also called the experimental cohort. Nurses will be enrolled from the~     participating inpatient units to provide data on the clinical utility of the PAIN Algorithm~   "
71073|NCT02127073|"~     The purpose of this study is to examine the genetic material called microRNA of three types~     of specimens from women with breast cancer. The study also seeks to examine the~     effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid~     that can be collected during surgery.~   "
71074|NCT02127060|"~     Postoperative pain management remains a major challenge for surgeons. Despite huge~     technological advances in pain management, many researchers have documented that unrelieved~     pain remains common after surgeries, which is estimated that up to 75% of patients do not~     achieve adequate pain relief postoperatively. The major goal in the management of~     postoperative pain is to minimize the dose of medications to lessen the side effects while~     still providing adequate analgesia, because side effects of commonly used pain medications~     are known to be the reasons that could lead to inadequate postoperative pain treatment. This~     goal is best accomplished with multimodal analgesia. One agent that can exert~     antinociceptive and pain reducing effects is vitamin C.~      Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially~     highly concentrated in the brain, which has antioxidant and neuroprotective properties.~     Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery~     and the requirement for vitamin C increases in surgical patients, possibly due to greater~     demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute~     pain, a result from a recent study with the aim to evaluate the potential role of vitamin C~     in reducing acute pain after laparoscopic cholecystectomy showed that supplementation with~     oral vitamin C significantly decreased morphine consumption after surgery.~      Although vitamin C has potential for relieving postoperative pain, there has not been~     studied regarding the effectiveness of vitamin C for spine surgery, to date. This trial~     aimed to evaluate the effectiveness of vitamin C for surgery of lumbar spine.~   "
71075|NCT02127047|"~     Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the~     course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass~     in type 1 diabetes may be improved through inhibition of beta-cell destruction and~     stimulation of proliferation, even after prolonged duration of disease.~      Physical activity improves insulin secretion via unknown underlying mechanisms. We recently~     observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release~     from the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release~     of Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6~     levels. Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like~     peptide-1 secretion from the islet α-cell and the intestinal L-cell, thereby providing a~     mechanism how physical activity can help maintain and improve beta-cell function in patients~     with type 1 diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV~     inhibition.~      Physical activity is also known to enhance insulin sensitivity and to attenuate the immune~     system activity.~      Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to~     allow for beta-cell regeneration in a interventional randomized open-label study.~   "
71076|NCT02127034|"~     The purpose of this study is to evaluate the effect of steady state solifenacin and~     mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will~     also evaluate the safety and tolerability of the combined steady state administration of~     solifenacin, mirabegron and digoxin.~   "
71077|NCT02127021|"~     Up to now, the studies concerning nutritional assessment after pancreatic resection were~     rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant~     benefit in terms of nutritional status. This study is a multicenter randomized phase IV~     study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional~     status after pancreaticoduodenectomy.~   "
71078|NCT02127008|"~     Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue.~     Anatomic studies on posterior epidural space and its contents are few, including semifluid~     property. In other words, there has not been studied thoroughly regarding the significance~     and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the~     posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface~     of thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which~     were free under this layer. The anterior surface of this membrane lay close to the dura~     mater without any attachment.~      To date, the epidural fat has been resected routinely by pituitary forcep and suction~     drainage during posterior lumbar surgery. However, the investigators focused on the role of~     epidural fat, which might be associated with postoperative outcome. The investigators~     thought that this peculiar character, epidural fat, should be caused by certain etiologies.~     In general, each tissue, such as epidural fat, has its inherited features and significance,~     thereby the epidural fat has also specific role. However, there has not been fully studies~     regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural~     fat on the postoperative outcomes such as pain intensity and functional outcomes by whether~     the epidural fat would be resected or not during posterior decompressive surgery. The~     investigators hypothesized that the epidural fat would be associated with postoperative pain~     intensitive, functional outcomes, and complications of the surgery such as failed back~     surgery syndrome. In this study, new device for resection of epidural fat was not utilized,~     but just resected with conventional devices such as pituitary forcep.~   "
71079|NCT02126995|"~     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2 study of~     MG01CI (low dose and high dose once daily) for 6 weeks compared with placebo in a 1:1 ratio~     of 60 adolescent and adult subjects with Fragile X Syndrome (FXS). Following Screening,~     subjects will be randomized to MG01CI or matching placebo at Baseline (Day 0) and the 6 week~     Double-blind Treatment Period will begin on Day 1.~      The first 4 weeks of the treatment period will be a dose-optimization period,~      All subjects will start with two daily tablets: low dose metadoxine or matching blinded~     placebo. At weekly visits/phone assessments, the investigator will evaluate the dose based~     upon the investigator's assessment of safety and tolerability. If the subject demonstrates~     safety or tolerability concerns with the low dose after 1 or 2 weeks of treatment, then the~     subject will be discontinued. If there are no concerns about safety and tolerability after 2~     weeks of treatment, then the dose will be increased to high dose or placebo. If at the high~     dose there are concerns about safety and tolerability, then the dose will be either kept the~     same or reduced to low dose for the remainder of the treatment period.~      There will be a 2-week Follow-up Period after the last dose of study treatment or early~     termination.~   "
71080|NCT02126982|"~     Clopidogrel besylate (CB) is not differentiated relative to the orignal clopidogrel hydrogen~     sulfate (CHS) in the pharmacokinetics and in antiplatelet potency in healthy volunteers. In~     addition,CB exhibits similar pharmacodynamic properties compared to CHS in patients with a~     history of acute coronary syndrome (ACS) and in patients with ACS undergoing percutaneous~     coronary intervention (PCI). However, there is a lack of data on the clinical efficacy and~     safety of this salt to the original salt in patients with cardiovascular disease. The aim of~     this study is to investigate the clinical efficacy and safety of CB in relation to that of~     CHS in patients eligible to receive clopidogrel.~   "
71081|NCT02126969|"~     The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely~     low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this~     effect differs from the cellular effect of higher, standard fractions of radiation used in~     traditional radiation treatment paradigms.~   "
71082|NCT02126956|"~     The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to~     identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them~     with the known metabolic profiles of ACT-128800 in animals.~   "
71083|NCT02126943|"~     Prospective observational drug registry developed to characterize the safety profile~     (including primarily potential serious hepatic risks) and to describe clinical~     characteristics and outcomes of patients newly treated with Opsumit in the post-marketing~     setting.~   "
71084|NCT02126930|"~     The main objective of this study is to evaluate the impact of a pharmaceutical consultation~     at the time of hospital discharge on the adherence of patients ; non-adherence is determined~     by the following criteria:~      As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria~     is true:~        1. . the patient did not go and get his/her treatment at the pharmacy;~        2. . the number of treatment units dispensed by the pharmacy is < the number of treatment~          units prescribed;~        3. . the patient stopped taking a treatment before the recommended time, or continued~          taking a treatment after the recommended time;~        4. . the number of treatment units taken by the patient (self-declaration) is < or > to~          the number of units prescribed.~   "
71085|NCT02126917|"~     To determine the influence of co-ingestion of alcohol on HC-ER.~   "
71086|NCT02126904|"~     The investigators compared the time to recurrence after ranibizumab or aflibercept loading~     in patients with AMD.~   "
71087|NCT02126891|"~     To attest if a cardiac fatigue appears (and to measure it if it does) during intense~     physical exercises in two groups of subjects:~        -  Canoeists from a training center of the French canoeing team during an intensive~          session of three weeks of endurance training;~        -  Young recruits in military school of officers in ground forces of the French army~          during an intensive.~   "
71088|NCT02126878|"~     Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed~     fluid filled sac or sac-like cavity found between tissues that function as a gliding surface~     to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the~     trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause~     of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a~     local steroid injection. The injection consists of a mixture of local anesthetic and steroid~     medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to~     diluent the steroid as well as act as a pain reliever. Various steroid preparations have~     been used, at varying doses, for trochanteric bursitis. The steroid preparation,~     triamcinolone is commonly used for various reasons. Besides the procedure associated and~     injection site risks, risks associated with the use of steroids, though rare, exist. Short~     term, the steroid can raise blood sugar levels and should be used with caution and be~     appropriately monitored in diabetics. Additionally, the steroid can suppress the immune~     system. Long-term risks are related to the dose and frequency of use. These risks include~     thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract~     formation, thinning of bones and joints. Studies have shown the effectiveness of local~     steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the~     ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but,~     studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this~     study is to evaluate and compare the effectiveness of local steroid injections of various~     steroid dosages for the treatment of trochanteric bursitis.~   "
71089|NCT02126865|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1060469 in healthy male and female subjects after oral administration of repeated rising~     doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and~     in asthmatic male and female patients after oral administration of repeated rising doses of~     25 mg and 150 mg qd of 1 day followed by 28 days.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality, dose linearity after single and multiple dose segments, pharmacodynamics~     (PD) of BI 1060469 and to describe the PK/PD relationship.~   "
72821|NCT02104154|"~     To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the~     test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry~     analyzer.~   "
71093|NCT02126813|"~     Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty~     needs intermittent bladder catheterization after surgery, as they are transient incapable of~     voluntary bladder emptying (postoperative urinary retention - POUR). The currently used~     interventional threshold for urinary bladder catheterization are a bladder volume of~     approximately 500 ml., but no evidence exists for this threshold. At the same time, the~     current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in~     humans, and as the use of urinary bladder catheterization are increasing the risk of~     complications, the investigators are hypothesizing that increasing the interventional~     threshold for urinary bladder catheterization after fast-track total hip or knee~     arthroplasty, will reduce the number of patients needing urinary bladder catheterization,~     without increasing the incidence of urological complications - including urinary tract~     infections.~   "
71094|NCT02126800|"~     Treatment of breast cancer has traditionally been based on the primary tumour's features in~     the breast. Only recently, when cancer returns at other sites, has there been an attempt to~     biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be~     technically difficult, painful and, when possible, only represents a small sample of one of~     many metastases.~      Even when one deposit responds to a new treatment, a neighbouring one may continue to grow.~     There is an urgent need to characterise all deposits, particularly the lethal ones which~     progress despite all treatments.~      This study will enable the comprehensive analysis of the metastatic process and the~     evolution of the breast cancer through the course of its treatment. Patients who have~     consented during life to donate their tissues for molecular analysis will provide the means~     for such an analysis.~      Main aims:~        -  To comprehensively and systematically examine metastatic breast cancer by its detailed~          exploratory molecular characterization to elucidate the possible inter- and~          intratumoural heterogeneity between the primary tumour and the majority of metastatic~          sites.~        -  To map the natural history of the metastatic breast cancer process~   "
71095|NCT02126787|"~     Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in~     day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality~     disorders in Poland. There is not enough evidence for its effectiveness in this environment.~     This study addresses this gap. The aim is to determine the effectiveness of the two kinds of~     day treatments consisting of intensive, short-term group therapy: psychodynamic and~     cognitive-behavioral for patients with anxiety disorders and comorbid depressive or~     personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment~     in a day care setting relative to wait-list control; 2) Demonstrating the relative short-~     and long-term effectiveness of the two active treatments; 3) Preliminary examination of~     predictors and moderators of treatment response; and 4) Preliminary examination of mediators~     of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the~     outcome of used measures.~      Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety~     disorders and comorbid depressive or personality disorders will be assigned to one of three~     conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3)~     waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized~     (manuals will address comorbidity). Primary outcome measures are include self-report~     symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized~     diagnosis of anxiety disorder. Secondary outcome measures include personality, depression,~     self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems,~     object relations, parental bonding, meta-cognition, mindfulness and quality of life:~     symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures~     are taken at baseline, post-treatment and 3 months following the end of the therapy.~      Discussion: The randomized controlled trial format is used to compare effectiveness of~     intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for~     anxiety disorders and comorbid depressive or personality disorders. The rationale is to~     investigate how effectively anxiety disorders and comorbid personality disorders can be~     treated in a day hospital typical for Polish healthcare system in 3 months treatment.~   "
71096|NCT02126774|"~     HEP is a five-year, prospective, observational study whose primary goal is to identify~     clinical characteristics and biomarkers predictive of disease outcome, progression, and~     treatment response in participants with newly treated focal epilepsy.~   "
71097|NCT02126761|"~     In this study, the safety and immunogenicity of the current formulation of aTIV will be~     compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be~     doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in~     independently-living elderly subjects ≥ 65 years of age.~   "
71098|NCT02126748|"~     The purpose of this study is to investigate the effectiveness of two airway clearance~     techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in~     hospitalized infants under the age of 2 with acute viral bronchiolitis.~   "
71099|NCT02126735|"~     CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat~     concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in~     the CD36 gene are more common in African Americans compared to Whites and it may confer~     protection against metabolic diseases by altering the amount of fat in the blood.~      The purpose of this study is to compare the levels of fat in the blood and to assess~     endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of~     the CD36 gene after a high fat meal challenge~   "
71100|NCT02126722|"~     H. pylori infection is the most important causative agent of gastritis, and subsequent~     atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests~     such as the Clo test. However, treatment with proton pump inhibitors (PPI) impairs the~     diagnostic yeld of urease tests. The EndoFaster test (NISO BioMed, Turin, Italy) is a new~     technology that has the advantage, over conventional urease tests, of a real-time analysis~     of the gastric juice that can provide information regarding Helicobacter pylori infection~     and pH value of the gastric contents. A well designed clinical study is therefore warranted~     to fully assess the performance of the EndoFaster test in detecting H. pylori infection in~     patients treated with PPI. We aim to perform a clinical study in an adult population in~     United Kingdom in order to determine the diagnostic accuracy of the Endo Faster test~     compared to the Clo test, histological diagnosis and the faecal antigen test in evaluating~     H.pylori infection. Patients on PPI will undergo a gastroscopy with multiple biopsies and~     during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out.~     H. pylori faecal antigen test will also be performed and used as gold standard. Diagnostic~     accuracy of the different methods will be determined.~   "
71110|NCT02126592|"~     Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is~     characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic~     abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost~     60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS~     patients tend to be overeating suggests that impaired appetite regulation might be~     contribute to the pathophysiology of PCOS. Our study is trying to observe difference of~     incretin between PCOS and normal control to figure out whether change of incretin is~     involved in the pathophysiology of PCOS.~   "
71101|NCT02126709|"~     Importance This will be a proof of concept study - whereby we hypothesize that Repigel may~     represent a paradigm shift in global acne treatment.~      Historically, there has been a dearth of clinical evidence in this use of povidone-iodine~     for inflammatory acne. This is likely due to staining related to iodine use, which is not~     acceptable to consumers.~      The trial drug, Povidone Iodine, however, becomes colourless and odourless in a matter of~     seconds after application on the skin.~      This represents an ideal product for which we may perform testing to look at its efficacy in~     the management of acne.~      A mainstay in the pathogenesis of acne involves the overgrowth and proliferation of skin~     micro-organisms, primarily proprionibacterium Acnes. Long term antibiotic therapy is usually~     prescribed for a period of 3 to 6 months or more.~      Previous studies have revealed this form of antibiotic therapy is ineffective, patients are~     usually poorly compliant, and also results in the formation of antibiotic resistant~     micro-organisms,which in turn reduces treatment efficacy.~      Potential Benefits~      As such, Povidone Iodine with its antiseptic property represents a promising avenue for the~     elimination of Proprionibacterium Acnes without the associated problems of long term~     antibiotic use, and the development of antibiotic-resistance. It is cosmetically acceptable,~     affordable, and easy to use.~   "
71102|NCT02126696|"~     This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral~     therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic~     treatment failure as well as chronic communicable and non-communicable comorbidities among~     patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to~     determine prevalence of treatment failure as well as the prevalence of the following~     comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol~     use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with~     treatment failure or a comorbidity or both are followed-up for 12 months.~   "
71103|NCT02126683|"~     Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects~     up to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8~     - 3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and~     antibody-mediated immune processes. Various auto-antibodies may be present against TPO and~     Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of~     cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper~     T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory~     cytokines in serum of patients with HT, and suggested HT is associated with regulatory~     T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17~     cells.~      Several studies suggested that pregnant women with HT, even at euthyroid state had higher~     risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive,~     anger, and total mood disturbance risk compared to those without HT. Presence of thyroid~     auto-antibodies is also associated with negative pregnant outcomes including gestational~     hypertension, late abortion, fetal death, premature delivery and neonatal respiratory~     distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism.~     Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and~     development of goiter and thyroid dysfunction. However, there is no suggested treatment for~     subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up~     were suggested.~      Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several~     autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a~     century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune~     mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells,~     dendritic cells and monocytes.~      This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory~     markers, cytokines, and goiter size in euthyroid women with HT.~   "
71104|NCT02126670|"~     The purpose of this study is to determine whether or not ACT01 is effective and tolerable~     alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with~     facial and/or scalp keratosis.~   "
71105|NCT02126657|"~     Our study involves the evaluation of a high potency chemical peel in its efficacy and safety~     profile for the treatment of acne scars. This chemical peel regime is a high potency peel of~     70% glycolic acid combined with vitamin C that is purported to provide a good balance~     between yielding results and patient safety. We aim to evaluate its efficacy and safety~     profile of a single application. The study design is based on a single group that compares~     pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be~     recruited. Potential benefits include improvement of post acne scars with a short downtime~     and risks include post peel hyper pigmentation and scarring. We believe that this treatment~     will be highly beneficial to patients with post acne scarring.~      This chemical peel regime has good efficacy and safety profile for the treatment of acne~     scars.~   "
71106|NCT02126644|"~     Our study involves the evaluation of a high potency peel in its efficacy for skin~     rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency~     peel 70% glycolic acid combined with vitamin C that is purported to provide a good balance~     between yielding results and patient safety.~      AIM We aim to qualitatively evaluate its efficacy and safety profile.~      Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will~     result in improvement of the features of photoaging with few side effects.~   "
71107|NCT02126631|"~     This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a~     patch monitoring system, with the Holter monitoring system. Holters represent the current~     standard for continuous recording of the ECG over extended periods.~   "
71108|NCT02126618|"~     The aim of this study is to estimate the amount of extra urine produced by natural diuresis~     during 20-minute pad test, and assess the effect of diuresis on the accuracy of using~     20-minute pad test to estimate the severity of SUI. Besides, the above results may be used~     for further refinement of the amount of water infusion used for the 20-minute pad test.~   "
71109|NCT02126605|"~     Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a~     way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed~     the ability of DADs to accurately detect extreme high and low blood sugar. The current~     project is the first preliminary investigation into the accuracy of DADs, using~     scientifically rigorous research methods similar to those required to demonstrate accuracy~     in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs~     are accurate at detecting extreme blood sugar levels in adults and children with T1D. The~     proposed project has several other secondary aims, which include determining: 1) the~     glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to~     which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners~     appear to experience better psychosocial status and quality of life compared to other~     individuals with T1D.~   "
73027|NCT02101476|"~     The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by~     mouth every 12 hours for the management of acute moderate to severe post operative pain to~     generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.~   "
71112|NCT02126566|"~     Striae distensae is a common skin condition that rarely causes significant medical problems.~     However, it often results in a considerable amount of distress to those with the condition.~     Various modalities of treatments have been used for striae distensae but few have led to~     satisfactory results.~      More recently, newer techniques such as pulsed dye laser and radiofrequency devices have~     been used with modest results. There is still, however, paucity of data using light therapy~     for the treatment of this condition. Blue light therapy using the Multiclear device has been~     used successfully in the treatment of acne. In contrast, there is little data to suggest its~     use in the management of striae distensae.~      We aim to study the effects of blue light on the treatment of striae distensae and whether~     this can be used safely to manage this condition.~   "
71113|NCT02126553|"~     The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to~     keep AML patients in remission. The safety of this drug will also be studied.~   "
71114|NCT02126540|"~     To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy~     while using directional visualization and imaging as an adjunct to fluoroscopy to aid~     removal of plaque from diseased lower extremity arteries.~   "
71115|NCT02126527|"~     This phase I clinical trial studies the side effects and best dose of auranofin and~     sirolimus when given together in treating patients with non-small cell lung cancer.~     Immunosuppressive therapy, such as auranofin and sirolimus, may be an effective treatment~     for non-small cell lung cancer. Sirolimus may also stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving auranofin and sirolimus may be~     an effective treatment for non-small cell lung cancer.~   "
71116|NCT02126514|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion~     study to evaluate the mass balance, metabolite profiles, and rates and routes of elimination~     of [14C]-AZD3293 and derived metabolites following administration as a single 100-mg~     (containing approximately 150 µCi) oral dose (as an oral solution)~   "
71117|NCT02126501|"~     To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in~     premature babies born between 26 and 32 weeks~   "
71118|NCT02126488|"~     The long-term objective of this research is a prophylactic approach that can reduce the~     incidence of falls and the resulting injuries among older adults at risk and thus reduce its~     escalating medical cost. This project explores perturbation training through the use of~     treadmill device and a motor learning approach, in which experience with slip-like~     perturbation generated by that treadmill is used to prepare the motor system to develop and~     then put to use fall-resisting skills outside of training environment (cross-environment~     transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus~     conducive for use in clinics or community centers. The study logically builds on and~     complements the team's previous and current research programs, and will further test that~     after such a single session, older adults at risk can retain such cross-environment transfer~     and reduce their likelihood of falls in everyday living for the next 6 to 12 months.~     Finally, the study will explore that such reduction of falls does not come merely from these~     persons' familiarity with the training or testing setup, protocol and environments.~   "
71119|NCT02126475|"~     Although major progresses were realized during recent years, temporal cognition is still~     poorly understood. However, abnormal temporal cognition is an underestimated aspect of~     several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore,~     the interest of studying temporal cognition is double: firstly, it is an essential function~     necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of~     dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a~     degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc).~     Therefore, in this project, PD patients and healthy volunteers will be used as a model to~     study the role of dopamine in temporal expectation.~      An expectation is an internal representation of an event that is likely to occur in the~     future. Temporal expectation builds-up as time elapses before the upcoming event. The role~     of temporal expectation in the oculomotor domain has often been studied using anticipatory~     eye movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to~     the knowledge of the investigators, expectation and anticipation have so far been studied in~     experimental tasks where temporal information is essential but not voluntarily controlled.~     This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye~     movement adapts to the timing of the target, implicitly and without voluntary control of the~     subject. However, anticipatory movements can also be based on an explicit estimation of~     time, e.g. during music playing. In summary, timing can be based on cognitive (explicit) or~     automatic (implicit) processing. The originality of the behavioral task the investigators~     will use in this study is that it will require an explicit comparison of a memorized~     duration with elapsing time in order to anticipate target appearance. In this task,~     expectation of the upcoming event will build up on explicit temporal information.~      Same PD patients will be tested under treatment (ON) and without treatment (OFF) to~     determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson~     patients will be included and among them only those receiving levodopa and/or dopa agonists~     three times daily at a stable dosis since 30 days.~      the investigators hypothesize that eye movements latency will not linearly covary with~     objective time in OFF PD patients. In treated PD patients, a recovery of the linear~     relationship between subjective and objective time is expected. This would clearly~     demonstrate the role of dopamine in temporal expectation in humans.~   "
71120|NCT02126462|"~     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator~     americanus hookworm life cycle that are thought to play a role in the parasite's degradation~     of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1~     has protected dogs and hamsters from infection in challenge studies. This study will~     evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy~     Gabonese adults living in an area of endemic hookworm infection.~   "
71121|NCT02126449|"~     Preclinical studies provide strong support for the concept that fasting evokes resistance to~     multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates~     intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance.~     Accordingly, the currently available preclinical evidence suggests that short-term fasting~     protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not~     protected, as a result of their self-sufficiency in growth signals. This phenomenon is~     termed Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects~     of chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to~     chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data~     indicate that a specifically designed very low calorie, low amino acid substitution diet~     (Fasting Mimicking Diet, FMD) has effects on cancer therapy that are very similar to those~     of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy~     of neoadjuvant chemotherapy in women with stage II or III breast cancer.~   "
71391|NCT02122887|"~     The investigators expect an intervention that focuses on actual dialogue and familiarity~     with members of the other culture, discussion of empathy, generosity, and kindness, and~     focus on adaptive and reciprocal modes of conflict resolution will alter both physiological,~     behavioral, and mental response to the pain of the other, increase empathy, and reduce~     hostility.~   "
71122|NCT02126436|"~     The purpose of this study is to evaluate the feasibility and effectiveness of acupuncture~     for the treatment of phantom limb syndrome in lower limb amputees and pilot an acupuncture~     protocol. The study will be a comparative effectiveness study comparing acupuncture and~     standard care versus standard care alone and will be a randomised controlled trial using a~     mixed methods approach. The study hypothesis is a course of acupuncture will reduce the~     symptoms of phantom limb syndrome in lower limb amputees.~      The study will be based the Amputee Rehabilitation Unit, London. Twenty lower limb amputees~     with phantom limb syndrome will be randomly assigned to either receive usual care or usual~     care plus acupuncture. Acupuncture intervention will include 8 treatments over 4 weeks and~     treatment will involve using both body and auricular acupuncture points. Usual care will~     include physiotherapy, occupational therapy, pharmacological intervention and other~     interventions as deemed appropriate by clinical staff.~      An eleven point numerical rating scale will be the primary outcome measure in this study.~     Secondary outcome measures will include the Short Form McGill Pain Questionnaire 2,~     EQ-5D-5L, Hospital Anxiety and Depression Scale, Perceived Stress Scale, Insomnia Severity~     Index, Participant Global Impression of Change and information will also be obtained on~     rescue medication. A cheek swab will also be taken to explore potential subgroups of~     responders in relation to the genetic polymorphism of the glucocorticoid receptor. Outcomes~     will be recorded weekly for the duration of the study and one and three months post~     completion of the study. In order to identify protocol acceptability and acceptability of~     outcome measures five participants will be interviewed post completion of the study. Data~     will also inform feasibility such as recruitment rate, completion rate and reasons for~     dropout.~      Data from this study will guide the development of a full randomised controlled trial.~   "
71123|NCT02126423|"~     The administration of short courses of topical antibiotic drops before and/or after~     intravitreal injections is a common practice, but increasing evidence suggests this may not~     lower the risk of infectious endophthalmitis and could increase rates of antimicrobial~     resistance. The purpose of the present study is to determine the antimicrobial resistance~     profiles in patients who have received numerous (≥ 20) courses of antibiotics for~     intravitreal injection compared with untreated controls.~      This study compares 20 control patients without prior intravitreal injection to 20 patients~     who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical~     antibiotics for two days before and/or after the injection procedure. The lower, inner~     eyelid and nasal cavity were cultured and evaluated via disk diffusion method for~     antimicrobial sensitivity.~   "
71124|NCT02126410|"~     1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese~          population. However, within the context of self-reported sleep duration and health~          risks, research into the association between sleep duration and body composition~          changes in older people is limited. It is important to gain an understanding of such an~          association of older people to estimate the public health burden.~        2. OBJECTIVES: To assess the association between self-reported sleep duration and~          sarcopenia as well as obesity in community-dwelling older adults.~        3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia~          and obesity in community-dwelling older adults.~        4. DESIGN: A cross-sectional investigation.~        5. SETTING: Communities in Zhongzheng district, Taipei.~        6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264~          women) aged 65 years and older.~        7. MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from~          the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal~          muscle mass was estimated by the predicted equation from a bioelectrical impedance~          analysis measurement. The Groningen Activity Restriction Scale and the Chinese~          Geriatric Depression Screening Scale were used to evaluate physical disability and~          depression, respectively.~   "
71125|NCT02126397|"~     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of~     endometrial polyps. In recent years we have used the bipolar energy for resection of polyps~     by hysteroscopy, becoming a routine clinical practice and universally accepted.~      Resection of endometrial polyps laser energy has recently begun to be used with satisfactory~     results, so studies are needed to analyze these results and compare it with the usual~     techniques .~      This time in advance of medicine, it is appropriate to introduce minimally invasive~     procedures , allowing resection of endometrial polyps on an outpatient basis without~     anesthesia and acceptable to most patients.~      These procedures assume a lower cost and are associated with a lower surgical risk due to~     their realization without anesthesia .~      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of~     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique~     with a high percentage of resection and high degree of satisfaction of patients~   "
71126|NCT02126384|"~     The purpose of this study is to determine which B lymphocytes subsets are responsible for~     the production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after~     vaccination with a 23-valent pneumococcal polysaccharide vaccine.~   "
71127|NCT02126371|"~     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma~     A/S (the Sponsor), with an aim to help people with skin conditions called psoriasis. The~     aim (s) of this Study are to determine:~        -  The effects of the Study Drug when given as different formulations intended for oral~          administration (tablets and capsules)~        -  The safety of the Study Drug and any side effects that might be associated with it~        -  The effect of food on the Study Drug~        -  The Study will also measure how much of the Study Drug gets into the blood stream and~          how long it takes the body to remove it and what affect the Study Drug has on the body.~   "
71128|NCT02126358|"~     To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin~     50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia~   "
71129|NCT02126345|"~     The purpose of this study is:~        -  to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support~          existing short-term clinical results and CE documentation;~        -  to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT~          acetabular cup under standard conditions of use;~        -  to determine any adverse events and assess whether they constitute risks when weighed~          against the intended performance of the device.~   "
71149|NCT02126085|"~     Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective,~     randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1~     : 1 to either non-intubated state or to intubated state for endovascular stroke treatment.~     Otherwise, no principal differences in intensive care treatment are intended, and standard~     operating procedures are applied to ensure uniform management decisions in fields such as~     ventilation, sedation, cardio-vascular and cerebral monitoring and management.~   "
71392|NCT02122874|"~     Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas~     and improves glycemic profile in diabetic patients~   "
71130|NCT02126332|"~     Acute pancreatitis (AP) is a common disease whose incidence in the US reaches 35 per 100,000~     population annually. Its main causes in adults are gallstone migration into the common bile~     duct and alcohol abuse. Approximately 80% of patients with AP will develop a mild disease~     for which the management is mainly conservative. However 20% will develop a severe form,~     which is known to be associated with the development of local complications, such as~     pancreatic and peripancreatic necrosis, pseudocysts, and systemic complications, such as~     adult respiratory distress syndrome or renal failure. In the severe form of AP the mortality~     rate can reach 17% mainly due to multiple organ failure and pancreatic necrosis. In~     particular, pancreatic necrosis is associated with a death rate of up to 40%.~      Epidural anesthesia (EA) is widely used to induce analgesia in the perioperative period and~     has also been used to decrease pain in patients with AP. In addition, experimental studies~     have shown a specific beneficial effect of EA in AP, attributed to an anti-inflammatory~     effect of local anesthetics administered in the epidural space combined with a sympathetic~     nerve blockade, which redistributes splanchnic blood flow to non-perfused pancreatic~     regions.~      To date, EA has not been adequately tested in intensive care unit (ICU) patients with severe~     AP, with regards to clinical outcome. The objective of our study is therefore to test the~     effect of EA on lung dysfunction during severe AP, as we hypothesize that EA could limit~     lung failure requiring invasive mechanical ventilation (MV) or the duration of invasive MV~   "
71131|NCT02126319|"~     The purpose of this study was to examine whether a cognitive-affective preparation was more~     beneficial, in general, and more specifically for certain subgroups, such as~     African-American men and individuals with high monitoring style.~   "
71132|NCT02126306|"~     Oral administration of betaglucosylceramide was shown effective in reducing inflammation in~     animal models and was found safe in humans.~   "
71133|NCT02126293|"~     Children with chronic kidney disease, even after transplantation, may be at risk for bone~     problems due to an imbalance of calcium and phosphorus in the blood, especially as their~     kidneys progressively fail to function. While some drug and diet treatments are available to~     prevent such bone disease, many children refuse to take them due to bad taste and tummy~     cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can~     form in the blood vessels, eventually clogging them and resulting in heart problems.~     Investigators are studying possible new methods to help the kidneys maintain a normal~     balance of nutrients in the blood which is important for growing healthy bones and the~     prevention of side effects in blood vessels that can lead to heart disease. One method is to~     improve the team work of a hormone FGF-23 and a protein called Klotho that together~     stimulate the kidneys to increase phosphate removal. Investigators propose that this problem~     may be due to low blood zinc levels which often occur in children with kidney disease. Thus,~     in this study, investigators propose to first measure zinc in blood from children with~     chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate~     status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children~     will receive zinc supplementation for 3 months. After treatment with zinc, the same blood~     measurements will be repeated to determine if the zinc supplements have helped the hormones~     to remove phosphate from the body. If this pilot project is successful, investigators will~     then consider a larger scale project involving adult patients as well as pediatric patients~     from other pediatric centers. This project will also guide investigators as to whether they~     need to introduce zinc measurements as part of routine testing of CKD and transplant~     patients. In addition to measuring zinc levels in study participants, trace elements (TE)~     will also be measured. These include heavy metals such as cadmium, chromium, nickel,~     vanadium, copper, lead, manganese and selenium. Very little is known about levels and~     metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel,~     and vanadium probably accumulate in hemodialysis patients, while copper and lead may~     accumulate. Manganese, selenium are probably deficient. The study will allow investigators~     to obtain the information about TE in this group of pediatric patients.~   "
71134|NCT02126280|"~     The study of proinflammatory and anti-inflammatory cytokines and chemokines expression~     profiles in human monocytes to identify new effective biomarkers that have the best~     diagnostic potential in asymptomatic atherosclerosis.~   "
71135|NCT02126267|"~     Evaluate and compare the effectiveness in a clinical and microbial perspective one stage~     full-mouth disinfection technique in relation to scaling and root planing per quadrant~     associated with chlorhexidine or azithromycin.~   "
71136|NCT02126254|"~     The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the~     common treatment strategy (based on clinical judgment) on morbidity and mortality in~     patients with decompensated congestive heart failure, and accordingly to assess whether the~     NICaS system can optimize and individualize the treatment of decompensated heart failure~     patients. A prospective randomized controlled trial in which Known HF patients, with reduced~     EF <40%, admitted due to decompensated HF, will be randomly assigned, in a 1:1: ratio, to~     either: 1) Control group that will be treated in the cardiology and internal medicine~     departments according to the guidelines for the management of Heart Failure. 2) Hemodynamic~     group patients will be examined in the cardiology and internal medicine departments and~     treated according to the NICaS system in addition to current guidelines. Patients in this~     group will be tested within 12 hours from hospitalization and thereafter on an everyday~     basis until discharge. For all patients randomized, therapy will be tailored to the ultimate~     goal of discharge on an oral medical regimen to provide better relief of CHF symptoms, to~     reduce filling pressures and to maintain adequate perfusion. These goals are the same for~     both groups, but in the control group therapy will be adjusted according to clinical~     assessment alone, while in the NICaS-directed group, actual measurement of hemodynamics will~     be used to supplement clinical assessment.~   "
71137|NCT02126241|"~     This proposal aims to evaluate the added clinical and echocardiographic benefit of using the~     non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing~     atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT~     recipients.~   "
71138|NCT02126228|"~     The purpose of this study is to discuss whether the parturients who underwent elective~     cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and~     economic benefits involved.~   "
71184|NCT02125630|"~     A randomized trial evaluating resection of the primary breast tumor in women presenting with~     de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully~     selected patients presenting with stage IV breast cancer suggest that surgery on the primary~     tumor may result in improved survival, but this remains unproven. The early results of our~     ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women~     with distant metastases at presentation who receive loco-regional treatment for intact~     primary tumor compared with those who do not receive such treatment) showed that patients~     with bone metastasis only have a trend toward improved survival with initial surgery.~   "
71185|NCT02125617|"~     The purpose of this study is to investigate cleavage products of the urokinase~     plasminogenactivator receptor (uPAR) in plasma from patients with castration resistant~     prostate cancer as a predictive marker of response to abiraterone.~   "
71139|NCT02126215|"~     Hypothesis: Patients with blue cerebrovascular reactivity (CVR) regional maps during a~     hypercapnic CO2 challenge will be at greater risk of developing post-operative delirium~     (POD) and stroke following major surgery. The blue CVR map will be shown to be predictive of~     POD and stroke and ultimately represent a diagnostic test for patients at risk. These blue~     CVR maps will enable neurologic risk stratification for patients undergoing major surgery. A~     secondary hypothesis is that location and extent of the blue CVR maps will strongly indicate~     risk of neurologic sequelae after operative procedures. Background: Major surgery is~     associated with a significant risk of postoperative morbidity and mortality. POD is a~     dreaded complication with such anesthesia and surgery. The prevalence of delirium after~     cardiac surgery has been reported to occur in up to 50% of patients. Using a definitive~     diagnostic tool such as the Confusion Assessment Method - Intensive Care Unit (CAM-ICU)~     results in the higher proportion reported. Delirium is a serious complication that results~     in prolonged length of stay, increased health care costs, and higher mortality. As much as~     $6.9 billion of Medicare hospital expenditures can be attributed to delirium. At such a~     cost, better diagnosis and treatment is urgently needed. Pre-emptive diagnosis leading to~     better management of delirium post-operatively is clearly one of the fundamental problems~     confronting modern anesthesia and peri-operative medicine.~      Specific Objectives: The investigators seek to address (a) the identity of patients who have~     the greatest vulnerability to the surgery and (b) investigate the risks and test appropriate~     risk mitigations. Understanding POD is of immense import to help control a hospital's~     surgical and critical care costs. Patients with neurological consequences including POD~     often represent a choke point for optimized critical care utilization. At the very least,~     improved understanding and a diagnostic test to highlight patients at risk of POD would be~     most welcome. Such an advance would permit rational strategies to limit the problem and~     allow better designed therapeutic arcs for patients now known to be at risk. This is~     especially important for patients undergoing complicated major surgery and is the focus of~     this pilot project.~   "
71140|NCT02126202|"~     A multicenter, randomized clinical trial in elderly patients (over 80 years old) with~     unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).~      A total of 200 patients will be randomized to medical treatment (100 patients) or coronary~     angiography with revascularization if feasible (100 patients). Information regarding prior~     history, frailty, clinical presentation, in-hospital events, complications, angina, quality~     of life and mortality will be collected. Follow up time is 1 year.~   "
71141|NCT02126189|"~     This study is designed to refine the aetiological causes of cancers of the head and neck and~     investigate the ways in which human papillomavirus and life-style factors cause head and~     neck cancers. This study will determine if these factors affect the treatment of cancer.~      All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is~     invited to complete a risk factor questionnaire and give consent for their clinical data and~     tissue samples to be available for future research activities. The risk factor questionnaire~     is based on existing validated instruments developed by the QIMR Berghofer Medical Research~     Institute Cancer Control Group, and will collect standardised information relating to~     demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition,~     asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical~     activity, diet quality etc) and behaviours (oral sex etc)~   "
71142|NCT02126176|"~     The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment~     applied on unit area of eczema influence the efficacy of treatment.~   "
71143|NCT02126163|"~     Excessive alcohol use is associated with a range of serious and costly health, social, and~     economic consequences at the individual and societal level. This program of research serves~     as a venue by which to produce and test an innovative, science-based, and cost-effective~     means to intervene in a private, convenient, and individualized way with employed adults who~     report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored~     intervention sessions directed at increasing readiness to limit drinking to national~     guidelines for low-risk drinking and a complementary dynamic web portal providing additional~     information, activities, and strategies designed to activate and reinforce the change~     process. The primary objective is to complete and enhance the development of Responsible~     Drinking and test it in an effectiveness trial. In Phase II the program capabilities and~     innovation will expand to integrate the e-Health components (CTI and e-Workbook) with~     m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a~     more interactive and engaging user experience. In addition, m-Health technologies (text~     messaging and mobile device browsing optimization) will be integrated to support engagement~     in the program and flexible delivery options. 996 employed adults will be recruited to~     participate in the randomized trial. The treatment group will receive three intervention~     sessions during the course of six months and group differences on a number of outcomes will~     be evaluated at 12 and 18 month follow-up assessments.~   "
71144|NCT02126150|"~     The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore.~     From these two sites we include all patients who undergo a coronary catheterization for any~     reason.~      At the moment of catheterization we draw blood, which will be stored in a biobank and we~     collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of~     major cardiovascular events.~      By including from two sites in the world we include 4 major ethnic groups: Caucasians,~     Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.~      Our hypothesis is that there are differences in the risk factor burden, clinical~     presentation of CAD, and biochemical patterns in the blood among the ethnic groups.~      Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.~   "
71145|NCT02126137|"~     Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and~     80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause~     for liver transplantation in Chile. Even though treatments are evolving with new direct~     antiviral agents (DAAs) that are increasing response rates, there are several issues with~     these new approaches, including increased toxicity, need for using interferon and ribavirin,~     complex algorithms of treatment, high cost, limited effectivity in certain groups (liver~     transplant patients) and drug interactions. Treatments targeted at host factors required for~     the viral cycle are becoming increasingly explored as an alternative or complement to DAAs.~     It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor~     of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter~     in the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an~     approved and generally safe drug used for the management of hypercholesterolemia. Our~     hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption~     with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20~     mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV~     RNA and core antigen in plasma, bile and feces.~   "
71146|NCT02126124|"~     The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham~     treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette~     smokers.~   "
71150|NCT02126072|"~     Objective: To determine the immediate effects of oral alcohol consumption in healthy~     volunteers on gut wall integrity as measured by I-FABP and LBP.~      Study design: Randomized, single blinded cross over study.~      Study population: 15 healthy adult male human volunteers will be included in this study.~      Intervention: the consumption of alcoholic beverages (1 g/kg ethanol) of wine (12%) compared~     to the consumption of water.~      Main study parameters/endpoints: The aim of this study is to determine the immediate effects~     of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by~     I-FABP and LBP.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects consume 1g of alcohol per kg bodyweight. One blood sample of 14 ml~     followed by 6 samples of 8 ml will be drawn between 16.45 hours and 19:00 hours the day~     after. The first 6 observations take place in a single visit followed by one observation in~     short visit the next day. It is unlikely that subjects will experience any physical or~     psychological discomfort from the withdrawal of a total of 62 ml of blood in 24 hours or the~     consumption of the amounts alcohol or water mentioned above. The same protocol will be~     repeated one week after the first visit in which the alcohol group and water group are~     crossed over.~   "
71151|NCT02126059|"~     Cognitive function, behavioral and psychological symptoms, and quality of life will improve~     after administration of cognitive stimulation therapy, reminiscence therapy, and~     aroma-massage therapy in patients with dementia.~   "
71152|NCT02126046|"~     Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia~     major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT)~     platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients~     with leukemia, cytopenia post-transplant often developed, which was considered as a symptom~     of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the~     Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of~     this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of~     Hi-HSCT in patients with β-thalassemia major.~   "
71153|NCT02126033|"~     Celiac disease is an autoimmune process that causes destructive changes in the epithel of~     the small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is~     to examine telomere length and other parameters of genetic instability from peripheral blood~     lymphocytes of patients with celiac disease compared with healthy controls.~   "
71154|NCT02126020|"~     The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several~     causes of corneal blindness. Some categories of patients, including those with auto-immune~     diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous~     membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic~     inflammation, the cornea supporting the KPro may melt, leading to a higher risk of~     infection, loss of the KPro and loss of the eye.~      Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to~     control inflammation in several diseases. It has been used in some cases of corneal melting~     with significant success.~      This study's hypothesis is that infliximab can be successfully used as an eye drop (instead~     of the usual administration through veins) and that its regular use may prevent melt in eyes~     with a Boston Keratoprosthesis type I and underlying auto-immune disease.~   "
71155|NCT02126007|"~     This randomized clinical trial (RCT) pilot study as two main objectives:~        -  determine the overall feasibility of a behavioral intervention for managing fatigue~          among older adults with HIV infection.~        -  to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions~          of fatigue.~      The investigators hypothesize that adherence, satisfaction, and attrition will be similar~     for the active intervention group and the attention control group. The investigators also~     hypothesize that all five dimensions will improve in the intervention group compared to~     controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5~     SD units for all five fatigue dimensions at all three post-intervention time points.~   "
71156|NCT02125994|"~     It is established that the local anesthetic that is administered during an interscalene~     block affects the autonomic outflow to the heart. This is very well seen during shoulder~     surgery when the patient is positioned in beach chair pasition.~      The investigators want to study the different effect of the two concentrations (0.5% and~     0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate~     measurements.~   "
71157|NCT02125981|"~     The limaprost alfadex can improve the surgical outcomes in patients with cervical~     myelopathy.~   "
71158|NCT02125968|"~     The purpose of this study is to investigate the video game play therapy in patients with~     chronic low back pain.~   "
71159|NCT02125955|"~     Currently, over one third of Canadian children and youth aged five to seventeen are~     overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as~     type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers.~     Changes in the food supply have been linked to obesity and include a decrease in the intake~     of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate~     the composition and actions of the gut microbiota and have been shown to reduce body fat and~     energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic~     fiber intake in overweight and obese children will similarly result in improvements in body~     composition and reduced energy intake.~   "
71186|NCT02125604|"~     The primary objective of this study is to evaluate the effect of symptomatic therapies on~     gastrointestinal-related events reported by participants with relapsing-remitting multiple~     sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice~     setting.~      The secondary objectives of this study in this study population are as follows: To evaluate~     gastrointestinal-related events requiring symptomatic therapy and the role of those~     therapies over time; To evaluate gastrointestinal-related events that lead to a physician's~     decision to manage the events with BG00012 dose modification; and To evaluate~     gastrointestinal-related events that lead to BG00012 discontinuation after the use of~     symptomatic therapy.~   "
71187|NCT02125591|"~     The purpose of this study is to evaluate improvement in balance after receiving physical~     therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).~   "
76341|NCT02058082|"~     The purpose of this study is to determine whether couples undergoing IVF/ICSI with male~     factor infertility, specifically with elevated sperm DNA damage, should testicular sperm~     extraction be utilized to improve their reproductive outcomes.~   "
71160|NCT02125942|"~     Borderline personality disorder is a severe psychiatric disorder marked by emotional~     instability, difficulty with interpersonal relationships, and self-harming behaviors.~     Despite receiving psychotherapy for borderline personality disorder, studies show that~     patient recovery is slow, and there is a high rate of self injury and suicide attempts early~     in treatment. There is thus a clear need to provide therapies to augment psychotherapy. We~     will conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery~     Therapy (CMIT) is feasible for subjects with borderline personality disorder to undergo when~     added on to psychotherapy treatment. CMIT is a non-validated therapy that combines~     principles of mindfulness with meditation techniques and guided imagery. Sessions led by a~     trained clinician in a group setting once a week, and participants are asked to complete~     daily home practice.~      The trial will involve 16 participants, all currently undergoing psychotherapy for~     borderline personality disorder. Participants will be randomly assigned to either a CMIT~     group that lasts 6 weeks, or a wait list group. Those in the wait list group will be able to~     receive CMIT after 6 weeks. All participants will continue to receive psychotherapy~     throughout the trial.~      During the trial, we will also obtain preliminary data to help understand whether CMIT may~     result in psychological benefits for participants. This will include measuring the pulse in~     order to determine variation in beat to beat intervals of the heart during psychological~     tests, and filling out questionnaires before and after participation in CMIT.~   "
71161|NCT02125929|"~     To determine the efficacy and safety of robotic, laparoscopic and open surgery for~     enucleation of benign pancreatic neuroendocrine tumors~   "
71162|NCT02125916|"~     The objective is to study the cognitive functions in patients with chronic obstructive lung~     disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy~     controls. The cognitive functions are tested with and without oxygen therapy to clarify the~     effect of oxygen therapy. Driving simulations is used to test the cognitive functions.~      The hypothesis is that patients with chronic lung disease have decreased cognitive functions~     and that oxygen therapy will increase their cognitive functions.~   "
71163|NCT02125903|"~     The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after~     total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by~     femoral nerve block mobilization of Patients is difficult even dangerous (falls) and~     hospital stays are extended.~      An alternative method could be an adductor canal block (ACB). Anatomical studies of the~     adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure~     sensory nerve for medial and anterior aspects of the knee and the tibia without any motor~     function.~      This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on~     quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).~      We expect the ACB to be superior in muscle strength but equal in pain score. Both groups~     receive an additional anterior sciatic nerve block for complete sensory block of the~     operated knee~   "
71164|NCT02125890|"~     An abdominal aortic aneurysm occurs when the part of the aorta travelling down into the~     abdomen balloons out more than 50%. If caught early, treatments can be used to prevent~     rupture of the aneurysm. However, many of these aneurysms are asymptomatic and go undetected~     until they rupture, causing large amounts of blood to spill into the abdominal cavity and~     typically leads to death, if left untreated. The current mortality rate is between 50 and~     90%. The resources required to treat patients with ruptured aortic aneurysms is quite~     substantial given that they need blood transfusions and can have prolonged hospital stays.~     Patients either undergo a more invasive operative repair, associated with greater blood~     products transfusions and complications, or if relatively stable, undergo a less invasive~     repair with tubes called stents. There is less morbidity associated with the latter,~     endovascular repair. To prevent blood loss in elective surgeries, drugs that promote blood~     clotting are often used. One drug, tranexamic acid , has been shown to reduce blood loss,~     reduce the number of blood transfusions required and improve patient outcomes in elective~     cardiac and orthopaedic surgeries, and more recently, in patients with traumatic hemorrhage.~     However, this drug has not been tested in this particular population. The purpose of this~     pilot project is to evaluate the effectiveness of tranexamic acid in reducing clinically~     significant bleeding in patients with ruptured aortic aneurysms in hospital sites across~     Saskatchewan using a single-group intervention design. The investigators will compare the~     data from patients treated with tranexamic acid to retrospective data from a control group~     that is matched on key variables. The investigators predict that tranexamic acid will result~     in reduced bleeding, reduced need for blood transfusions, less patients that require open~     surgery and improved patient outcomes. The results of this study will help determine if this~     treatment is effective at preventing the death of many people with ruptured abdominal aortic~     aneurysms.~   "
71165|NCT02125877|"~     Assessed the new film-coated tablet formulation to the currently approved dispersible tablet~     formulation with regards to overall safety, Gastrointestinal (GI) tolerability,~     palatability, satisfaction and compliance~   "
71166|NCT02125864|"~     The purpose of this study is to examine the plasma concentration of vascular endothelial~     growth factor (VEGF) after standard treatment with one of the newest growth factor~     inhibitors, aflibercept (Eylea).~      Patients with exudative age-related macular degeneration (AMD) are treated today with~     anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the~     eye and a more powerful effect on the edema in the macula than previously used growth factor~     inhibitors. This means that the disease can be controlled with fewer number of injections~     into the eye and the investigators can therefore reduce the risk of complications associated~     with this type of treatment.~      It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in~     patients with wet age-related macular degeneration is.~   "
71167|NCT02125851|"~     The purpose of this study is to determine if a xanthan gum or honey based budesonide slurry~     exhibit comparable mucosal contact time to a budesonide/sucralose slurry in healthy adult~     subjects.~   "
71188|NCT02125578|"~     The primary objectives are to identify the highest safe and well-tolerated dose and~     frequency of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of~     63 to 188 mcg, when given every other week or every 4 weeks to healthy volunteers (HV).~   "
71189|NCT02125565|"~     Arterial Blood Gas (ABG) sampling is a common procedure in all hospitals worldwide. Often,~     ABG samples are obtain from inserting a needle into the radial artery at the wrist - this~     procedure is often painful and dreaded by patients. Therefore, some doctors use local~     anaesthetic but others argue that it makes the procedure more difficult and causes pain~     itself. The use of local anaesthetic costs approximately £1 per injection and when thousands~     of ABGs are performed per month, the cost is easily appreciable. However, there is no good~     research to guide clinicians in the use or omission of local anaesthetic for ABGs. This is~     the first randomised clinical trial to assess the efficacy of injected local anaesthetic on~     the perceived pain of radial artery puncture.~   "
85691|NCT01935739|"~     The purpose of this study is to determine discordant HER2/neu status of primary breast tumor~     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer~     patients.~   "
71168|NCT02125838|"~     Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does~     not increase the incidence of gastric aspiration, the failure of ventilation or the risk of~     pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in~     spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in~     England for gynecological laparoscopic procedures. In addition in many previous studies LM~     has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical~     interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological~     interventions and identified advantages to LM use. The most important of these advantages~     was that, contrary to tracheal tube techniques for laparoscopic surgeries, use of~     supraglottic laryngeal devices or neuromuscular blocker agents (NBA) were not required~     during placement. Thus for laparoscopic surgeries, compared with the ETT technique, without~     the need for supraglottic laryngeal devices or muscular relaxants, it is easily placed and~     reduces the time spent in the operating room.~      Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic~     gynecological intervention with positive pressure ventilation from a surgical viewpoint and~     in terms of effect on ventilation parameters.~      Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.~   "
71169|NCT02125825|"~     The objective is to assess a compact, portable, wireless movement disorder system with~     continuous monitoring capabilities to detect and quantify the severity of levodopa-induced~     dyskinesia in Parkinson's disease.~   "
71170|NCT02125812|"~     The adjunctive use of systemically administered antibiotics has been shown to provide a~     better clinical outcome, particularly in terms of probing depth (PD) reduction and~     attachment-level gain than SRP in subjects with Aggressive Periodontitis.~      The overall objective of this study is to evaluate the clinical and microbiological efficacy~     of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing~     over placebo in the treatment of aggressive periodontitis.~   "
71171|NCT02125799|"~     High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and~     efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks.~     Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would~     have significant advantages in terms of access, patient acceptance and costs. In the present~     open label trial the investigators intend to assess the effectiveness and acceptability of a~     novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per~     day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be~     assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported~     measures as well as with computerized neurocognitive tests.~   "
71172|NCT02125786|"~     The primary purpose of this study is to investigate whether surgery and re-irradiation will~     help treat ependymoma that has come back after initial treatment. The combined doses of the~     first and second courses of radiation are higher than what is usual standard of care. The~     investigators will study the effects and side effects of surgery and re-irradiation. They~     will also evaluate and study tumor tissue and blood to learn more about the tumor and how it~     does or does not respond to treatments and will use magnetic resonance imaging (MRI) and~     positron emission tomography (PET) scans to see if they can predict tumor response and tumor~     recurrence.~      Participants will be followed for up to 5 years following enrollment. Evaluations during~     radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other~     evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and~     every 6 months during the 4th and 5th year.~   "
71173|NCT02125773|"~     This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to~     determine if providing high-risk subjects with a calculated risk score changes the~     likelihood of pre-exposure prophylaxis (PrEP) uptake.~   "
71174|NCT02125760|"~     This study is divided for development in two complementary work packages justified by the~     need to incorporate new strategies to optimize rehabilitation outcomes in stroke patients.~     The general objectives are: 1) to determine the prevalence of respiratory muscle dysfunction~     in stroke patients; 2) to identify the existence of a potential amino acid marker of~     increased risk of muscle dysfunction after suffering a stroke; 3) to evaluate the~     effectiveness of incorporating the respiratory muscle training as an innovative adjuvant~     therapy in stroke rehabilitation program that may decrease the incidence of morbidity and~     mortality in the medium and long term; and 4) to quantify the potential impact of~     respiratory muscle training on the costs of care for stroke patients.~   "
71175|NCT02125747|"~     The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of~     Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive~     pulmonary disease.~   "
71176|NCT02125734|"~     The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to~     show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung~     function. Similarly, this study aims to evaluate patient preference after experiencing both~     treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate~     to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at~     screening despite being treated with tiotropium~   "
71177|NCT02125721|"~     The purpose of this study is to evaluate the effect of escalating doses of cystine biding~     thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which~     is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall~     goal will be to help guide therapy and ultimately minimize unnecessary side effects caused~     by larger doses.~   "
71190|NCT02125552|"~     The primary objective is to determine whether the use of ultrasound guidance compared to~     standard IV access improves the proportion of successful IV placement on a first attempt for~     children in a pediatric emergency department who have predicted difficult access by a~     validated score. Secondary objectives include determining whether ultrasound-guided IV~     access lowers the overall number of IV attempts and/or reduces time to IV access. The~     investigators will also examine the duration of IV access and any complications related to~     IV access in both the traditional and ultrasound guided IV access group.~   "
72822|NCT02104141|"~     The purpose of this combination retrospective and prospective post market study is to~     examine the short term safety and efficacy of the ROI-A® interbody fusion device with~     VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and~     S1, with a focus on fusion rates and patient outcomes.~   "
71178|NCT02125708|"~     The most common reason for preterm prelabor rupture of membrane (PPROM) is an ascendance of~     infection. Moreover PPROM is one of the main risk factors for chorioamnionitis.~      PPROM-related morbidity and mortality is higher in the neonate than in the mother,~     especially in case of intrauterine inflammation. Of note, the most common biomarkers like~     CRP and leucocytes are not specific for uterine infections and have not been proven useful~     in these particular cases. Studies in intensive care medicine could show that there is a~     possible correlation between onset of infection and body-core-temperature.~      The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5~     minutes. It was originally invented to assess the moment of ovulation and optimize~     fertility.~      Twenty patients with verified PPROM between gestation week 22 and 27 should be included in~     this study. After gynecological and physical examination within verification of PPROM women~     will be informed and invited to participate in this study. Subsequently informed consent~     will be obtained and the OvulaRing® placed into the vaginal fornix.~      The investigators aim to describe a possible correlation between core-temperature and common~     biomarkers in clinical use for the detection of chorioamnionitis in patients with PPROM to~     possibly assess the optimal time for delivery subsequently.~   "
71179|NCT02125695|"~     The main objectives of the study are: To determine if RNA recovery from tape harvesting~     allows for the identification of a disease gene signature (e.g., interferon [IFN] signature~     for lupus) or other biomarkers that may differentiate affected from normal or unaffected~     skin; To determine if the lupus gene signature is differentially expressed in the epidermis~     from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus~     (SCLE) lesions when compared with unaffected skin from the same participants and from the~     skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature~     is differentially expressed in the epidermis from active AD lesions when compared with~     unaffected skin from the same participants and from the skin of HVs; and To correlate the~     levels of transcripts of targeted genes in the skin by tape harvesting with those obtained~     from the blood.~   "
71180|NCT02125682|"~     Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin~     increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level.~     However, atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a~     better reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is~     superior to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number~     and function (better anti-oxydant activity)~   "
71181|NCT02125669|"~     Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic~     approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking~     due to inconsistent design of available studies. The purpose of this study is to evaluate~     the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low~     risk anatomical sites in an evidence based study setting.~   "
71182|NCT02125656|"~     Sleep is an essential biological process for life and great value to functions such as~     learning, memory processing , cell and brain repair. Recently, new evidence points to the~     relationship between lack of sleep and carbohydrate metabolism , establishing a framework~     for insulin resistance observed in studies with restriction and sleep deprivation on several~     nights and in a single night . To reverse this process , one of the most effective~     strategies is physical exercise and part listed in the literature as a non-pharmacological~     tool for prevention and health promotion , as well as in the treatment of some diseases .~     However , the pace of modern society causes people to practice less physical exercise , lack~     of time being the main reason . In this scenario, the High Intensity Interval Training (~     HIIT ) emerges as a powerful strategy that induces major changes optimizing the time spent~     on such activity. Considering the benefits of this mode , the purpose of this study is to~     investigate the effects of high-intensity interval training in the context of insulin~     resistance observed during sleep deprivation. Will be recruited 20 male volunteers, aged~     between 18 and 35 years old, healthy, with normal sleep duration equivalent to 7-8 hours /~     night, not smoking and regular eating habits. They will be submitted to a protocol of 6~     sessions of high-intensity interval training for two weeks, and since the end period, sleep~     normally, or be deprived of sleep for 24 hours. Biochemical (thyroid hormones, cortisol,~     glucagon, free fatty acid, cholesterol, glucose and insulin) will be undertaken as well as~     evaluation of body composition by plethysmography, basal metabolic rate by indirect~     calorimetry and insulin sensitivity through Oral Glucose Tolerance Test (OGTT) before and~     after the training period.~   "
71183|NCT02125643|"~     We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to~     placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo~     in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced~     H-reflex) compared to placebo in undamaged muscle. 4) Caffeine will raise the pressure-pain~     threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in~     undamaged muscle. 5) Caffeine will reduce the amount of low-frequency fatigue, indicated by~     an enhanced 20-100 hertz strength ratio, compared to placebo in undamaged muscle. 6)~     Caffeine will increase maximal voluntary strength compared to placebo in damaged muscle. 7)~     Caffeine will increase muscle activation compared to placebo in damaged muscle. 8) Caffeine~     will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in~     damaged muscle. 9) Caffeine will raise the pressure-pain threshold (indicating decreased~     pain sensitivity) in the calf muscle compared to placebo in damaged muscle. 10) Caffeine~     will reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz~     strength ratio, compared to placebo in damaged muscle.~      The proposed research will determine the effects of a 5mg/kg body weight dose of caffeine on~     muscular strength, activation, H-reflex function, and excitation-contraction coupling before~     and after exercise-induced muscle damage. The long term objectives are to gain a better~     understanding of caffeine and its affects following exercise-induced muscle damage allowing~     us to understand how caffeine is mechanistically interacting with functions of the body.~   "
71241|NCT02124889|"~     Additional micronutrient supplementation is required due to the changes in the~     gastrointestinal anatomy and physiology following bariatric surgery along with decreased~     dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential~     to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis~     of this study is that patients receiving a weekly survey intervention will have better~     adherence to post-operative vitamins than a control group not receiving the survey.~   "
71191|NCT02125539|"~     The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my~     Journey program for adolescents receiving treatment in an outpatient substance abuse center.~      The primary hypotheses are that, relative to the control condition, Navigating my Journey~     will be associated with significantly higher motivation, higher self-efficacy, improved~     relapse coping skills, and lower substance use. The secondary hypotheses are that, relative~     to the control condition, Navigating my Journey will be associated with increased~     therapeutic alliances with counselors.~   "
71192|NCT02125526|"~     Patients presenting with large myocardial infarction and signs of persistent ischemia after~     successful percutaneous coronary intervention, have a poor prognosis with respect to outcome~     and development of heart failure in the future.~      The hypothesis of this study is that in patients in whom persistent ischemia is present, use~     of intra-aortic balloon pump will be beneficial and improve outcome.~   "
71193|NCT02125513|"~     The purpose of this study is to define whether 6 courses of neoadjuvant chemotherapy can~     lead to a higher rate of complete cytoreductive surgery compared with 3 courses of~     neoadjuvant chemotherapy in patients with epithelial ovarian cancer, fallopian tube cancer~     or primary peritoneal cancer.~   "
71194|NCT02125500|"~     Aim of the study is to assess the efficacy and safety of 24 weeks of oral~     Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection~     and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated~     interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.~   "
71195|NCT02125487|"~     The purpose of this study is to determine whether the use of hybrid simulation of the breast~     are more effective in teaching CBE technique and culturally sensitive doctor-patient~     communication skills to medical students than the traditional method.~   "
71196|NCT02125474|"~     Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing~     number of new cases reported in the annual statistics of the Instituto Nacional de~     Cancerología (INC). The majority are advanced-stage presentations with limited chances of a~     complete surgical resection of the primary tumor, a clinical scenario where medical~     treatment options are also limited. In view of the characteristically defined expression of~     peptide receptors in WDNETs, radioactive molecular probes to target specific cellular~     receptors have been designed using radioisotopes with short range of penetration in tissues.~     We have designed a one-arm phase II prospective sequential clinical trial to assess the~     therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied~     intravenously in three separate doses to patients with inoperable progressive WDNET.~     Selected patients matching inclusion criteria will be enrolled at the INC's Section of~     Endocrinology. Tumor response, treatment safety (side effects) and survival will be~     appraised. Data from clinical, biochemical and imaging follow-up will be periodically~     registered during treatment and until two years after the last infusion of 177Lu- DOTATATE.~     This phase II trial is justified because despite the fact that many preclinical and clinical~     studies have showed the potential usefulness of this novel palliative approach to treat~     patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its~     efficacy as first-line treatment.~   "
71197|NCT02125461|"~     A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in~     Patients with Stage III Unresectable Non-Small Cell Lung Cancer.~   "
71198|NCT02125448|"~     Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant~     chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed~     independent of the response to nCRT and is associated with substantial morbidity. A~     pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological~     non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity~     and delay from surgical therapy inevitably occurs in this group. Early identification of~     non-responders during nCRT would allow individualized decision making in continuation or~     discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment~     response after nCRT to identify patients with a complete response. Studies in rectal cancer~     reported that tumor resection could be omitted in patients with persisting clinical complete~     response after 12 months. Also, in some esophageal cancer studies, complete responders in~     surgical and non-surgical treatment groups had comparable overall survival. These findings~     indicate the possibility to perform nCRT as sole treatment in patients with a complete~     response. Conversely, if residual tumor is demonstrated, this will support the decision to~     move to surgery.~      Objective: Diagnostic study to assess the distinct and combined value of anatomical and~     functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron~     emission tomography and computed tomography (PET-CT) in the evaluation of treatment response~     to nCRT for patients with esophageal cancer.~      Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the~     imaging before, during and after nCRT for assessment of response to nCRT for resectable~     esophageal cancer. Imaging response measurements will be compared with the histopathological~     tumor regression grade (TRG) of the resection specimen as gold standard.~      Study population: 50 patients (>18 years) presenting at the UMC Utrecht or M.D. Anderson~     Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy,~     computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to~     surgery.~      Procedure: In addition to the conventional diagnostic work-up for esophageal cancer~     including a standard PET-CT before nCRT, two PET-CT scans will be performed during and after~     nCRT as well as three MRI scans before, during and after nCRT at the same time points. The~     first MRI (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the~     start of nCRT. The second scan session will take place after 10-14 days after the start of~     nCRT. The third and final scan session will be planned 1-2 weeks before surgery.~      Main study parameters/endpoints: Determination of the distinct and combined diagnostic value~     of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT~     for patients with esophageal cancer. Important imaging parameters include apparent diffusion~     coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the~     different time points. The differences of these values between time points are of particular~     interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%),~     negative predictive value (%), positive predictive value (%), and accuracy (%) of the~     different imaging parameters for correctly identifying histopathological complete response~     will be calculated.~   "
71199|NCT02125435|"~     The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK)~     of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and~     female subjects and to evaluate the pharmacodynamics of ASP2408.~   "
71200|NCT02125422|"~     Transcranial direct current stimulation is a tool to modulate cortical excitability.~   "
71201|NCT02125409|"~     In a preliminary study in healthy subjects, the investigators determined the pharmacokinetic~     and pharmacodynamic of enteric-coated acetylsalicylic acid (ASA) (Adiro 100 mg, Bayer), and~     the variability (coefficient of variation), accuracy and precision of a novel biomarker of~     ASA action, i.e., quantification of the extent of COX-1 acetylation at serine-529, using a~     stable isotope dilution liquid chromatography multiple reaction monitoring/mass spectrometry~     (LC-MS) technique.~      Now, the investigators will perform a clinical study in individuals undergoing Colorectal~     cancer (CRC) to validate the hypothesis that that low-dose ASA given once daily is acting~     primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout~     the 24-hour dosing interval. In contrast, it is expected that the inhibitory effect on~     extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially~     COX-1, and this effect will be completely reversed at 24 hours after dosing. This is an~     important point which will strengthen the platelet hypothesis underpinning the apparent~     adequacy of a 24-hour dosing interval of ASA administration for the anticancer effect~     detected in cardiovascular trials.~      These patients will be stratified into individuals with adenomas/carcinomas (20 to 30%) and~     patients without clinically detected adenomas/carcinomas (about 70 to 80%).~   "
71202|NCT02125396|"~     Despite advances in our understanding of hepatocellular carcinoma (HCC) and its diagnosis,~     the prognosis for patients with HCC remains disheartening, due to a high recurrence rate and~     frequent intrahepatic metastasis. Various therapies for use after hepatic resection have~     been reported, but they are associated with adverse side effects or they fail to improve~     overall survival. Nowadays, adjuvant transarterial chemoembolization (TACE) is recommended~     as the most effective therapy for postoperative HCC. And the indication is patients with~     risk factors of recurrence. While more and more prospective studies revealed that~     radiotherapy is effective for advanced HCC. And the side effects of radiotherapy are~     controlled. Until now, no prospective or retrospective study compared the efficacy of~     adjuvant TACE and radiotherapy for postoperative HCC.~   "
71203|NCT02125383|"~     The purpose of this study is to evaluate the effects of transcranial direct current~     stimulation (tDCS) on patients with Parkinson's disease during sleep.~   "
71242|NCT02124876|"~     The purpose of this study is to quantify residual limb fluid volume changes between morning~     and afternoon hours, and to determine if fluid volume change is correlated with activity.~   "
71243|NCT02124863|"~     The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation (~     airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from~     0 to 12 months.~   "
71204|NCT02125370|"~     This study is largely a qualitative study with a small survey component. The aim of the~     survey would be to gain a quantitative perspective of how women use NRT after this has been~     prescribed by stop smoking services (SSS). The aim of the qualitative study would be to~     enhance knowledge of pregnant smoker's views and attitudes about their experiences of using~     NRT and in particular to understand why pregnant women who start using NRT often discontinue~     this early or do not use the medication as it is prescribed. This information is important~     for a number of reasons; firstly it will help health professionals and researchers gain an~     in depth understanding about how women experience using NRT, which may be used to help~     devise strategies for encouraging better adherence and which could be used in future~     clinical trials to gain a clearer understanding as to whether or not NRT is effective in~     pregnancy.~   "
71205|NCT02125357|"~     This study is being offered to patients who have castrate-resistant (also known as~     hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the~     prostate area to other parts of the body.~      The purpose of this study is to evaluate the effects of sequencing hormonal therapies~     (abiraterone acetate and enzalutamide) and to assess treatment efficacy of these two agents.~   "
71206|NCT02125344|"~     Two regimen are currently considered to have highest efficacy for patients with high-risk~     early stage breast cancer: sequential treatment of high dose epirubicin, taxane, and~     cyclophosphamide concomitantly with a dual HER2-blockade, and weekly treatment with~     paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin. The~     aim of the GeparOcto study is to compare those two regimen/strategies.~      Both regimens are myelosuppressive with a significant incidence of chemotherapy induced~     anaemia.~      The second aim of the GeparOcto study is therefore to compare the use of parental ferric~     carboxymaltose versus physician's choice for the treatment of chemotherapy-induced anemia in~     patients with iron deficiency.~   "
71207|NCT02125331|"~     This study is required to demonstrate that the non-invasive blood pressure (NIBP)~     measurement algorithms on two commercially available multifunction hemodynamic acquisition~     modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm~     (PDM-SUPERSTAT) and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm~     (PSM-Datex-Ohmeda), provide accurate NIBP measurements in accordance with the guidelines~     provided by the most recent International Organization for Standardization (ISO)~     81060-2:2013.~      Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and~     this study is being conducted in accordance with the most recent applicable standards.~      This study will assess neonate, infant, children, pediatric, adolescent, and adult patients~     as well as adults with chronic atrial fibrillation in a population that requires~     non-emergent heart catheterization.~      This is a study conducted to satisfy both standards for two NIBP devices and, as such, does~     not require a statistical hypothesis.~   "
71208|NCT02125318|"~     Anagrelide is a drug that has been shown to slow down how fast platelets are made in the~     bone marrow, and has been approved by the FDA for treating high platelets counts in patients~     with bone marrow disorders.~      Anagrelide Controlled Release (CR) is a new preparation of anagrelide that is made to~     dissolve more slowly than currently marketed versions of this drug. Because of this, the~     anagrelide is taken up into the blood more slowly. Researchers think that this slower~     release of the drug could help to lower side effects that might be caused by high blood~     levels when the drug dissolves as quickly as it does with the currently marketed product.~      The main purposes of this study are to see how well Anagrelide CR can control platelet~     counts in patients with high platelet levels, to see what kind of side effects it causes,~     and to measure blood levels of the drug.~   "
71209|NCT02125305|"~     This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral~     administration in healthy elderly male volunteers.~   "
71210|NCT02125292|"~     The purpose of this study is to compare the palatability of SHP429 capsule contents~     delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and~     emptied into a cup and administered with water).~   "
71211|NCT02125279|"~     The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of~     treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to~     treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque~     psoriasis.~   "
71212|NCT02125266|"~     This study is intended to evaluate the safety of V404 PDS in patients with chronic~     non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide~     clinically measurable benefit over an extended period of time in patients with chronic~     non-infectious uveitis.~   "
71213|NCT02125253|"~     To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal~     Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal~     Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis~   "
71214|NCT02125240|"~     The purpose of this study is to compare 2 years of disease-free survival (DFS) of Icotinib~     and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung~     adenocarcinoma.~   "
71215|NCT02125227|"~     The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics~     of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the~     Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.~   "
71216|NCT02125214|"~     Temporal dynamics of the EEG microstates show scale-free monofractal properties. This means~     that information is encoded in the same way at different scales. It may be postulated that~     these monofractal properties of the EEG microstate sequences constitute a necessary~     prerequisite of consciousness. We postulate that clinical variations of consciousness may~     also be linked to alterations of fractal properties of EEG microstates.~   "
71244|NCT02124850|"~     Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who~     will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab,~     motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before~     surgery. The primary objective of the study is to determine the extent to which the~     administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and~     nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor~     infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An~     exploratory objective of the study is to assess whether modulation of biomarkers as~     described above can predict anti-tumor response.~   "
71217|NCT02125201|"~     Neonatal intensive care unit patients undergoes many painful procedures during their~     hospitalization. Effective pain control in such procedures as intubation, catheterization,~     central line insertion, chest tube insertion, etc. is an important part of treatment.~     Opioids administration is a common practice for acute pain prevention. Fentanyl is the~     preferred opioid due to it rapid onset and short duration of action.~      Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal~     administration is practiced for about 20 years. A rich vascular supply in a nose provides~     rapid absorption of the drug. This uninvasive root is now popular for pain prevention and~     treatment. There are about 20 trials with intranasal fentanyl administration to children~     from 6 month old to 18 years. The investigators did not find information about this way of~     administration in neonates.~      In our pilot study the investigators want to check if intranasal administration of fentanyl~     is safe and effective in pain prevention in term and preterm neonates during invasive~     procedures and to compare it with intravenous route of administration.~   "
71218|NCT02125188|"~     Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons~     and anesthesiologists despite several measures available for improving the surgical field.~     This study was conducted to evaluate the effect of desmopressin on blood loss and the~     quality of the surgical field in FESS.~   "
71219|NCT02125175|"~     High dose radiotherapy is a very effective treatment for prostate cancer. However, there is~     an increased risk of side effects compared to lower dose radiotherapy. This study will~     investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a~     high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose~     to the rest of the prostate. This may improve control of the cancer without increasing the~     side effects. The radiotherapy is given in 20 doses, called fractions.~   "
71220|NCT02125162|"~     The purpose of the study is to compare how the body takes up and then eliminates the study~     drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin~     capsule. This study will also evaluate whether food has any effect on how the body takes up~     BCX4161.~   "
71221|NCT02125149|"~     The purpose of the study is to determine how a mother's health and physical activity may~     influence her child's growth and development.~   "
71222|NCT02125136|"~     The aim ot the study is to investigate the efficacy and safety of two new intensified~     chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant~     chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and~     consecutive conversion of the tumor to resectability.~   "
71223|NCT02125123|"~     This study will investigate the effect of an oral nutritional supplement (ONS) along with~     dietary counseling on improving the dietary intake among children with picky eating~     behaviors.~   "
71224|NCT02125110|"~     This project aims at evaluating the consequences of prenatal exposure to neurotoxicants~     (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to~     12 years.~   "
71225|NCT02125097|"~     The purpose of this clinical investigation is to evaluate the safety and effectiveness of~     the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or~     branch intracranial aneurysms with any approved embolic coils.~   "
71226|NCT02125084|"~     The purpose of this study is to determine the safety and efficacy of a novel combination of~     agents, enzalutamide and everolimus, for the treatment of patients with metastatic~     castrate-resistant prostate cancer who have never received prior chemotherapy, or who have~     previously received docetaxel chemotherapy and have progressive disease.~   "
71227|NCT02125071|"~     An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V.~     Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.~   "
71228|NCT02125058|"~     Rationale:~      Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face.~     Treatment of choice is mostly excision and result in an irreversible scar. As the incidence~     of skin cancer is rising, also among young people, it is important to obtain a good cosmetic~     outcome after treatment. It is believed that the type of closure of the wound after excision~     can influence the cosmetic result. Currently, primary closure of the excision can occur by~     transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among~     dermatologists and plastic surgeons and the choice is mainly dependent on the preference of~     the physician. Research comparing the cosmetic result of both techniques in the craniofacial~     area is lacking.~      Objective:~      Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in~     the craniofacial area.~      Study design:~      A randomized controlled single-blinded multi-center trial.~      Study population:~      Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by~     primary closure at the department of Dermatology and Plastic Surgery of the Maastricht~     University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and~     the department of Plastic surgery of Orbis Medical Centre Sittard.~      Intervention:~      Excision of the tumor followed by IC sutures or TC sutures~      Main study endpoints:~      Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the~     patient and the researcher 12 months after surgery.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      All patients who participate have an indication for excision and will be assigned to one of~     the suture techniques. Both techniques are widely used in the regular patient care.~     Therefore, no extra risks are associated with it.~      Patients will be asked to visit the hospital 3 months and 1 year following treatment, at~     which point a questionnaire will be filled in and the redness of the scar will be measured~     by means of non-invasive techniques. In addition, patients will be asked to apply a~     sunscreen on the scar daily during the first three months of follow-up.~   "
71238|NCT02124928|"~     The aim of this study is to investigate the association of sonographic and histological~     features of the plaque among each other and with biomarkers of cardiovascular risk. The~     predictive value of these factors concerning the long-term clinical outcome after carotid~     endarterectomy will also be assessed. This may help to improve the identification of~     patients with carotid artery stenosis who will benefit most from carotid endarterectomy. The~     investigators major hypothesis is that the morphology of carotid plaques is associated with~     objectifiable sonographic parameters, in particular with the greyscale median. Second, the~     investigators hypothesize that sonographic and histological plaque morphology are associated~     with certain biomarkers of cardiovascular risk. Identification of 'vulnerable plaques' on~     the basis of a peripheral blood draw and a sonographic investigation may enable the treating~     physician to focus resources on patients who will benefit most form therapeutic~     interventions for primary prevention of ischemic stroke.~   "
71239|NCT02124915|"~     The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis~     use, perceived comfort, and satisfaction with the prosthesis are affected by size of the~     prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again~     after wearing a slightly oversized socket for 1 month.~   "
72875|NCT02103452|"~     Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non~     endometriotic ovarian and endometrial tissues.~   "
71229|NCT02125045|"~     Background. The antioxidant systems are the main endogenous defense against free radicals,~     and glutathione seems to play an important role in this mechanism. Reduced glutathione~     enters into the detoxification processes of endogenous products, such as hydro- and~     lipoperoxides and exogenous compounds such as pollutants, heavy metals and some drugs.~     Changes in GSH homeostasis have been implicated in the etiology and progression of several~     diseases. Supplementation of GSH may improve the endogenous antioxidant defense and may~     contribute to decrease of oxidants tissue damage a pathophysiologic mechanism of many acute~     and chronic diseases.~      However, the efficacy of GSH treatment seems to be closely related to the degree of its~     absorption and to the increase of its concentrations in plasma and cells. Previous studies~     of oral GSH administration in healthy volunteers or in patients failed to find any effect in~     terms of oxidative stress reduction and/or disease improvement because the GSH is quickly~     catabolized by gastrointestinal tract. We have recently observed (preliminary data) that a~     new sublingual formulation of L-GSH (OXITION), produced by PH&T S.r.l., is able to increase~     erythrocyte and plasma GSH levels in healthy volunteers bypassing gastrointestinal barrier.~      Objectives. The primary study objective is to determine whether medium term (4 weeks) of~     sublingual L-GSH supplementation to a population with smoking habit and/or arterial~     hypertension may result in improved endothelial function as assessed by the flow mediated~     dilation (FMD) technique versus placebo. FMD is a surrogate end point validated in the~     literature as prognostic predictor for major cardiovascular events in patients with~     endothelial dysfunction. Secondary study objectives are to determine differences between the~     2 treatment in terms of oxidative stress markers.~      Methods. This is a phase 3, double-blind, randomized, placebo-controlled, cross-over study~     performed in only one centre. Sixteen male subjects, aged ≥ 40 and ≤ 60 years, with smoking~     habit and/or hypertension defined as arterial blood pressure ≥ 140 and/or 90 mmHg or in~     anti-hypertensive treatment, will be enrolled and randomized to receive sublingual L-GSH~     (100 mg twice a day) or placebo according to a double-blind cross-over design for 4 weeks~     with a 3-week wash-out period between the two treatments. Baseline and at the end of each~     treatment period, FMD assessment and blood samples collection for routine (creatinine, urea,~     AST, ALT GGT, total cholesterol, HDL, LDL, triglycerides, fasting glucose) and specific~     (aminothiols, nitrotyrosine, malondialdehyde, 8-hydroxy-deoxyguanine) biochemical~     determination will be performed.~   "
71230|NCT02125032|"~     The aim of this study, is to determine whether treatment using transcranial low voltage~     pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's~     Disease (PD) experience. The symptoms include movement, mentality and the nervous system in~     general.~      Furthermore the purpose of this study is to clarify whether a group of patients with PD,~     gain a statistical improvement in their symptoms when treated with active T-PEMF, compared~     to a group of patients with PD who receive placebo T-PEMF .~   "
71231|NCT02125019|"~     Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.~   "
71232|NCT02125006|"~     Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best~     medical treatment, some survivors continue to experience disabling pain. It is~     well-established that an interdisciplinary approach is key to the treatment of some types of~     chronic pain, but little research has been done on the effectiveness of interdisciplinary~     treatments for cancer survivors with chronic neuropathic pain. The investigators will~     evaluate the effectiveness of an interdisciplinary approach combining medical treatment and~     mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life~     among breast cancer survivors with chronic neuropathic pain. The investigators will also~     evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of~     stress and immune function, cognitive function, as well as brain structure and function.~      The investigators will recruit 108 adult women survivors of breast cancer living with~     chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine~     specialist before being randomly assigned to either an 8-week group MBSR program or a~     wait-list. All participants will complete self-report questionnaires, provide a hair sample~     for cortisol measurements and a blood sample to measure several markers of immune function~     at four different time points: before medical treatment, after medical treatment and before~     randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month~     follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic~     resonance imaging before and after participation in MBSR.~      The primary outcome is pain interference. The investigators will compare the proportion of~     participants who report reduced pain-related disability, as measured by the Brief Pain~     Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month~     follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain~     Inventory Interference score) in the interdisciplinary program in comparison to medical~     treatment alone.~   "
71233|NCT02124993|"~     This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered~     food preferences before and after surgery.~   "
71234|NCT02124980|"~     If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and~     easy to use treatment to improve substance abuse outcomes for medication assisted treatment.~     Given the high costs of relapse and continued drug use, improvement of treatment outcomes~     would provide substantial health, economic, and societal benefits.~   "
71235|NCT02124967|"~     South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes~     and coronary heart disease (CHD) compared to the general population. Various explanations~     for these differences have been established, one of which is based on low levels of physical~     activity in people of SA origin, particularly in Muslim women.~      This pilot trial will test the feasibility, acceptability and effectiveness of a~     Mosque-based exercise and educational intervention designed for SA Muslim women.~        1. What is the feasibility of a mosque-based intervention to promote physical activity~          that is culturally and gender sensitive to South Asian Muslim women?~        2. What is the acceptability of a mosque-based intervention to promote physical activity~          that is culturally and gender sensitive to South Asian Muslim women?~        3. What is the effectiveness of a mosque-based intervention to promote physical activity~          that is culturally and gender sensitive to South Asian Muslim women?~   "
71236|NCT02124954|"~     A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and~     rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to~     see if there are any potential drug interactions that might affect patients in future~     studies. The study will examine whether co-administration of TA-8995 affects the~     pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).~   "
71237|NCT02124941|"~     Given prior evidence of reduced resting-state glucose uptake in prefrontal cortex (PFC) as~     measured by [18F]-FDG PET (Volkow 1992, 1993) and direct neurometabolic coupling of cortical~     glucose oxidation and glutamate transmission, we hypothesize that [13C]-MRS measures of VTCA~     and VCYC will be reduced in individuals abstinent from cocaine as compared to HCs. We will~     also explicitly explore potential relationships between VCYC and neurocognitive tests of PFC~     function and clinical outcomes (i.e., measures of relapse at 90-days outpatient follow-up).~     In addition to assessing resting-state glucose uptake in the PFC, we will explore whether~     open-label administration of either of three different pharmacological treatments (N-acetyl~     cysteine, riluzole, or pentoxifylline) increases VCYC, in cocaine users (CU) in comparison~     to their abstinence baseline.~   "
71240|NCT02124902|"~     This is a single arm open label phase II study in women with clinical stage 2 or 3 triple~     negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete~     response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived~     xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.~   "
71245|NCT02124837|"~     The objective of this research project is to understand and to improve workers´ recovery~     from work stress. Although recovery during lunch breaks is the most common within-workday~     break, it has received only minor research attention. Therefore, we will study whether lunch~     breaks including a relaxation session or exposure to nature have more favorable outcomes~     than usually spent lunch breaks concerning: a) recovery processes, b) health, c) well-being,~     d) job performance and e) creativity. We approach recovery by combining the theoretical~     frameworks of work and environmental psychology.~   "
71246|NCT02124824|"~     Heart disease is the leading cause of death in the United States, accounting for one in~     every four deaths in 2010 and costing over $300 billion annually in health care, medication,~     and lost productivity. Heart failure (HF), a clinical syndrome that develops as a~     consequence of heart disease, is characterized by the worsening of symptoms, such as dyspnea~     and fatigue, upon exertion, collectively defined as exercise intolerance. Surprisingly,~     exercise intolerance does not correlate with the degree of cardiac contractile (ventricular)~     dysfunction, suggesting that changes in the peripheral circulation may be to blame for~     exercise intolerance in this cohort. Though there are a host of factors that may contribute~     to this impairment, disease-related increases in circulating endothelin-1 (ET-1) may be a~     significant factor in the sequelae of exercise intolerance in HF. Thus, the overall purpose~     of this Small Projects in Rehabilitation Research (SPiRE) proposal is to explore the~     contribution of ET-1 to chronic vasoconstriction in HF patients, and to examine whether~     inhibition of this pathway could improve vasodilatory ability, and thus exercise tolerance,~     in Veterans with HF.~   "
71247|NCT02124811|"~     Schizophrenia is a major mental illness characterized by a variety of different symptoms~     including hallucinations, paranoia, difficulties with formulating and expressing thoughts,~     feelings similar to depression, and problems with cognitive processes. Individuals with~     schizophrenia are usually treated with a class of medications called anti-psychotics, which~     typically help alleviate some of the symptoms of the disorder. In general, anti-psychotic~     medications do not completely cure the disorder, and many patients are left with some degree~     of ongoing symptoms. Furthermore, it is estimated that 20-30% of individuals with~     schizophrenia are considered treatment refractory or resistant and do not respond to~     anti-psychotic medications. The Food and Drug Administration has approved one antipsychotic~     medication for use in patients who are considered to have treatment resistant schizophrenia~     (TRS). This medication, clozapine, has been shown to be beneficial for patients with TRS,~     though as many as 40-70% of patients fail to respond or are partially responsive to~     treatment with clozapine. In an extensive search of the medical and psychiatric literature,~     we have been impressed by the potential of minocycline, a tetracycline antibiotic, as an~     adjunctive therapy in patients with schizophrenia based on its reported neuroprotective and~     anti-inflammatory effects. It is a fairly inexpensive drug, well tolerated, and two~     randomized clinical trials have demonstrated favorable results in early-phase schizophrenia.~     Only one case series with two patients has investigated minocycline in patients with~     schizophrenia on clozapine. Minocycline is also an interesting medication for augmentation~     with clozapine, as we are interested in previous findings of increased inflammation in the~     brains of patients with schizophrenia and the potential role of inflammation in treatment~     resistant schizophrenia. Though there are many markers of increased inflammation in the~     brain, for this current study, we are interested in a general marker of inflammation called~     C-Reactive Protein (CRP). We hypothesize that some patients may have increased levels of~     inflammation in the brain, as measured by the CRP level (drawn from peripheral blood), and~     that those patients with increased levels of CRP may respond better to augmentation with~     minocycline. The proposed pilot study will compare minocycline augmentation with clozapine~     in individuals with high vs low inflammation as measured by CRP. We hypothesize that~     minocycline will be well tolerated and will result in an improvement in the symptoms of~     schizophrenia, cognition, as well as improve the quality of life for patients preferentially~     in patients with high CRPs. We plan to use a variety of different scales to measure~     improvement in the varying symptoms of schizophrenia as well as cognitive function, which~     will be administered to patients at three week intervals for a total study time of twelve~     weeks. We hypothesize that minocycline could prove to be an effective, well tolerated, and~     inexpensive medication for treatment resistant patients with schizophrenia whom have~     particular difficulties with social interactions, obtaining and maintaining employment, and~     overall quality of life. Furthermore, we hypothesize that the data obtained in this study~     will contribute to the ongoing exploration of the role of inflammation in the brain of~     patients with schizophrenia and help understand and target the role of various inflammatory~     markers in the pathophysiology and treatment of treatment resistant schizophrenia.~   "
71248|NCT02124798|"~     The primary objective of this study is to assess the suitability of the autoinjector for~     self-administration of belimumab by subjects with SLE in real-life conditions. The study~     will assess the use of the autoinjector inside the clinic setting and outside the clinic~     setting. The study will also assess the safety and tolerability of belimumab administered~     subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into~     the thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return~     for a follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be~     assessed by the investigators for success based on direct observation and/or the subject~     diary. A total of 118 subjects (treated with at least one dose of study drug) are planned to~     be enrolled in this study.~   "
71249|NCT02124785|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A~     in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.~   "
71250|NCT02124772|"~     This is a 3-part (Part A, Part B, Part C), Phase I/IIa, multi-center, open label, study in~     pediatric subjects with refractory or recurrent tumors. Part A is a repeat dose, dose~     escalation monotherapy study that will identify the recommended phase II dose (RP2D) on the~     continuous dosing schedule using a 3 + 3 dose-escalation procedure. Part B will evaluate the~     preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects.~     Each cohort will enroll at least 10 response-evaluable subjects (evaluable for response is~     defined as a subject with a pre-dose and at least 1 post-dose disease assessment or clinical~     assessment of progression of disease). Part C is will be a 3+3 study design to determine the~     safety, tolerability and preliminary activity of the RP2D of trametinib in combination with~     a limited dose escalation of dabrafenib. Part C will enroll up to 18 subjects. . The overall~     goal of this trial is to efficiently establish safe, pharmacologically relevant dose of~     trametinib in infants, children and adolescents and determine preliminary activity of~     trametinib monotherapy in selected recurrent, refractory or unresectable childhood tumors.~   "
71251|NCT02124759|"~     The purpose of this study is to determine the effect of high fat consumption on the~     intestinal microbiome, metabolic endotoxemia, and insulin action, in lean normal glucose~     tolerant subjects.~   "
71252|NCT02124746|"~     This open-label study is to determine the long-term safety and tolerability of momelotinib~     in previously enrolled study participants with primary myelofibrosis (PMF),~     post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia~     myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who~     have tolerated and achieved stable disease or better with momelotinib treatment while~     enrolled in a previous clinical trial.~   "
71253|NCT02124733|"~     This study is being done to compare a new, continuous illumination regimen of ALA-PDT~     (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic~     keratoses. The hypothesis is that the continuous illumination approach will be less painful,~     but equally efficacious, as the old regimen.~   "
72876|NCT02103439|"~     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with~     ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic~     hepatitis C in Human Immunodeficiency Virus-1 infected patients~   "
71254|NCT02124720|"~     Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal~     and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may~     considerably interfere with the child's daily functioning, learning, and social inclusion.~     As such, stereotypy generally has a negative impact on the child and family's health and~     quality of life. Several behavioural interventions have been developed to reduce engagement~     in stereotypy in children with autism spectrum disorders, but the limited number of~     specialists available, the long waiting lists associated with public health services in~     Canada, and the high costs of private services have considerably restricted accessibility.~     One potential solution to the limited availability and high costs of services is using a~     mobile application to recommend, teach, and monitor interventions designed to reduce~     engagement in stereotypy. To this end, the purpose of the study is to evaluate the effects~     of the iSTIM (i.e., individualized Stereotypy Treatment Integrated Modules), a mobile~     application designed to assist parents in reducing stereotypy in children with autism~     spectrum disorders. Specifically, we will assess whether the iSTIM correctly estimates the~     frequency or duration of stereotypy, offers suggestions consistent with recommended clinical~     practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe,~     and easy to use for parents of children with autism spectrum disorders. The results of the~     study will allow us to determine whether the mobile application may be used to treat this~     core symptom in children with autism spectrum disorders, which could potentially reduce~     waiting times and costs of providing health services to this population. By reducing~     engagement in stereotypy, the iSTIM may also promote and facilitate the social participation~     as well as improve the quality of life and health of children with autism spectrum disorders~     and their families.~   "
71255|NCT02124707|"~     This is a non-randomized, open-label phase II trial of 38 patients with recurrent or~     metastatic SCCHN. Patients must have ECOG performance status of 0-1 with good organ function~     and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab.~     Following assessment of response, the treating physician at their discretion may continue to~     treat with weekly cetuximab as maintenance until disease progression. The study is designed~     to evaluate whether this regimen improves median overall survival (OS) as compared to an~     historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is~     currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen~     options are highly toxic, inconvenient and resource intensive. Our study regimen has been~     used extensively for induction therapy and off-protocol in palliative care, but treatment~     outcomes have yet to be defined by a clinical trial.~   "
71256|NCT02124694|"~     This study will pilot an intervention that combines group Interpersonal Psychotherapy (IPT),~     an empirically-supported treatment, and the Historical Trauma and Unresolved Grief~     Intervention (HTUG), a Tribal Best Practice for American Indians. HTUG focuses on grief,~     depression, and trauma response resolution related to collective massive group trauma across~     generations, including the lifespan, for American Indians. We anticipate more positive~     responses to, and patient engagement in, the combined HTUG/IPT intervention than to IPT~     Only.~   "
71257|NCT02124681|"~     Current options to treat insulin resistance in diabetes are fairly limited. For this reason,~     novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ)~     has poorly understood effects on blood sugar metabolism. In this study, the investigators~     will examine the mechanisms by which this drug affects glucose metabolism and which cells~     are affected. Findings emanating from this project will help establish whether HCQ may be a~     viable treatment for disorders of glucose metabolism.~   "
71258|NCT02124668|"~     The purpose of this study is to monitor the safety of enzalutamide in patients with~     progressive castration-resistant prostate cancer previously treated with docetaxel-based~     chemotherapy.~   "
71259|NCT02124655|"~     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised~     to be the primary aetiological factor in the development of chronic gingivitis. Based on~     this association, the current treatment of gingivitis is focused on biofilm disruption,~     which will normally include mechanical processes, both professionally and at home. However,~     for patients, it is not easy to achieve a proper level of plaque control. The efficient~     plaque control techniques are very time consuming and require a special motivation and~     skills for their optimum use. It was at this point where mouthwashes become important, due~     to the fact that they include diverse types of antimicrobial agents to complement the~     results of mechanical oral hygiene measures.~      Chlorhexidine is considered the gold standard of oral antiseptics; nevertheless it has not~     been recommended for long periods of time due to its well-known secondary effects. All of~     these inconveniences have limited its acceptability among dental professionals and users; in~     contrast, however, are the exceptional antiseptic properties, promoting the interest of~     researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in~     their formulation have received a lot of attention. Their antiplaque activity has been~     demonstrated in numerous clinical studies, in which they were used in conjunction with~     mechanical oral hygiene measures.~      In order to achieve a better understanding of the clinical effects that antimicrobial agents~     produce in the interior of the biofilm, it is necessary to apply a methodology in which the~     biofilm grows directly in the interior of the oral cavity but its three dimensional~     structure is not distorted by manipulation.~      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial~     agents (essential oils formulation and 0.2% chlorhexidine) in the short term with a~     posterior analysis on non-destructured biofilm with Confocal Laser Scanning Microscope~     combined with fluorescence staining.~   "
71260|NCT02124642|"~     The proposed study is a double-blind randomized controlled trial in healthy pregnant women~     (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery~     clinic (ARMC).~      The primary goal of the proposed study is to determine relative changes in blood folate and~     DNA methylation levels in response to 2 different supplemental doses of folic acid one of~     which will provide the Institute of Medicine's recommended folate intake for pregnant women~     and the second will provide a higher dose as routinely taken by pregnant women in~     over-the-counter prenatal supplements.~      The specific aims of the study are:~        1. to compare maternal serum and red blood cell (RBC) folate levels and % change in women~          taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal~          visit (< 10 weeks) through delivery;~        2. to compare the infant's cord blood folate levels in response to different maternal~          folic acid intakes (400 mcg/d vs 800 mcg/d);~        3. to determine relative differences in the levels of oxidized folic acid in maternal and~          infant blood in response to 400 or 800 mcg/d folic acid dose, and~        4. to determine genome wide and gene specific DNA methylation response in pregnant women~          receiving prenatal supplements containing either 400 or 800 mcg folic acid per day~   "
71261|NCT02124616|"~     Our aim is to establish multi-center national Egyptian database of information for inherited~     and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.~   "
71262|NCT02124603|"~     The purpose of the present study is to elucidate the spectrum of ocular flora and their~     antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.~   "
71275|NCT02123381|"~     This study aim to investigate Changes in tumor tissue and serum biomarkers before and after~     cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower~     segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers~     to predict and evaluate the patients who will be benefit from cetuximab combined with~     preoperative radiotherapy.~   "
72888|NCT02103283|"~     A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular~     Edema.~   "
71263|NCT02124590|"~     This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke~     Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the~     effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin~     sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise~     provides more improvements in glucose control for pre-diabetic patients than vigorous~     intensity. The investigators hypothesize that moderate intensity exercise might be~     beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing~     damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the~     acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function~     as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing~     insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators~     intend to use the results of this study to show feasibility in measuring mitochondrial~     function at Duke for a larger federal grant submission. Investigators hypothesize that~     carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related~     impairments in glucose tolerance and insulin action.~   "
71264|NCT02124577|"~     This is a small preliminary study conducted to explore new methods for the potential of~     aiding in diagnosis of liver fibrotic disease as well as predicting disease progression.~     There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked~     to drink heavy water during most of that time. Heavy Water also known as deuterated~     water, is physically and chemically very similar to ordinary drinking water. It tastes and~     feels exactly like regular water. It is odorless and has no known harmful effects at the~     doses given here. Heavy water occurs naturally, and is a minor component of the water we all~     ingest daily.~   "
71265|NCT02124564|"~     This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200~     mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have~     partial-onset seizures with or without secondary generalization and who are treated with a~     single Anti-Epileptic Drug (AED) with marketing approval in Japan.~   "
71266|NCT02124551|"~     The purpose of this study is to assess the suitability of the ear and forehead as a better~     site for measure of fluid responsiveness.~   "
71267|NCT02123485|"~     The aim of the present study is to investigate in which degree low frequency right~     prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT~     and accelerate remission .~      To investigate the correlation between blood concentration of specific inflammation makers~     and change in depressive symptoms during treatment~   "
71268|NCT02123472|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours~     will pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
71269|NCT02123459|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours~     will pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
71270|NCT02123446|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin in capsules to determine if they are essentially the same. The study has two~     periods. Participants will receive one preparation of cephalexin in each period. At least 7~     hours will pass between the study periods. The study is expected to last about 2 days for~     each participant, not including screening or follow-up.~   "
71271|NCT02123433|"~     S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also~     cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects~     are more sensitive to invasive diseases and recurrent infection than the general population.~     Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more~     frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain~     and their nasopharyngeal isolates have features similar to subsequent invasive strains. A~     23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+~     population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+~     are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an~     hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover,~     PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of~     non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier~     proteins results in an improved T-cell dependent immune response, characterized by increased~     antibody concentrations and induction of T and B memory cells, with a demonstrated higher~     efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is~     approved in Europe since 2001 and is effective in reducing incidence of invasive disease by~     vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect~     of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes~     plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric~     patients, that are the main target of conjugate vaccines licensure. Some trials showed a~     better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as~     compared to PPV23. However these data were not unequivocally confirmed in further studies on~     the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults~     showed the same or even better response compared to PPV23, with a safety and tolerability~     similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for~     pneumococcal infections. The purpose of this study is to evaluate serological response and~     prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults,~     following vaccination with 2 doses of PCV13.~   "
71272|NCT02123420|"~     The present study tested the hypothesis that Platform Switching (PS) and Regular Platform~     (RP) implants would have different outcomes in the bilateral single tooth replacements~     against the alternative hypothesis of no difference.~   "
71273|NCT02123407|"~     Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by~     lymphatics after injection into the tissue and draining regional lymph nodes are thereby~     colored black,which may provide surgeons the guidance to lymph node dissection and help them~     harvest lymph nodes after surgery,especially some small ones. but there was insufficient~     evidence to justify its efficacy for those purposes.Therefore,the investigators carried out~     a prospective randomized controlled trial on lymph node vital staining for lymph node~     dissection and harvesting in advanced gastric cancer to test this idea.~   "
71274|NCT02123394|"~     The purpose of this study is to assess the efficacy of the McKenzie method in patients with~     chronic non-specific low back.~   "
71294|NCT02124317|"~     The purpose of this study is to determine the efficacy and safety of nanoparticle~     albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese~     patients with advanced pancreatic ductal adenocarcinoma (PDA).~   "
71276|NCT02123368|"~     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)~     of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients~     with knee osteoarthritis.~      Patients and methods~      Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10~     patients for each group. The investigators compare the intraarticular injection of~     hialuronic acid against the administration of two different doses of mesenchymal stem cells~     with hialuronic acid according to the following scheme:~        1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.~        2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous~          mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small~          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an~          intraarticular injection Hiaurónico Acid ( Hyalone®).~        3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous~          mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small~          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an~          intraarticular injection Hiaurónico Acid (Hyalone®).~      The primary endpoint is safety and feasibility. The investigators registered the occurrence~     of complications and / or adverse effects during the study.~      In addition the investigators assess the response to intra-articular infusion of CMM~     analyzing the following parameters:~        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since~          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.~        -  Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.~        -  Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the~          number location of the lesions , cartilage thickness , signal intensity , subchondral~          bone alteration , volume and WORMS and dGEMRIC protocols.~   "
71277|NCT02123355|"~     The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life~     quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD,~     and POCD is also correlated with many other factors such as type of surgery, the duration of~     anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in~     geriatrics is important.~      Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy~     whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the~     prolonged surgery.~      The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive~     function at prolonged surgery in geriatrics in geriatrics.~   "
71278|NCT02124525|"~     The purpose of this study is to investigate the efficacy of N-acetylcysteine (NAC) for~     smoking cessation in a double blind, randomized, placebo-controlled trial. Simultaneously,~     the study aims to elucidate the role of inflammatory markers and oxidative stress related to~     nicotine addiction and the use of NAC, an acetylated precursor of cysteine, a naturally~     occurring amino acid that has antioxidant actions in its own right, in reducing oxidative~     stress and inflammation in smokers. It will evaluate the use of NAC in smoking cessation,~     after 4, 8 and 12 weeks of treatment.~   "
71279|NCT02124512|"~     Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency~     towards diabetes, hypertension, and too much fat around the abdomen (an increased~     waistline). Individuals with metabolic syndrome often have impaired glucose tolerance, which~     is a condition where blood sugar is normal when fasting (before eating), but is too high~     after drinking a sugary drink. This is due to an abnormality in the body's sensitivity to~     insulin (insulin resistance), which is due in part to an inability of the muscle to take up~     glucose.~      People with metabolic syndrome have inflammation in their fat tissue and in their blood~     stream, and the changes in the level of inflammatory chemicals produced by cells in your fat~     tissues will be studied. One possible source of the inflammation may be the bacteria in the~     intestine. When individuals eat fatty foods, some of the bacterial products become attached~     to the fat in their blood and then get directed to fat tissue. The investigators wish to~     determine whether individuals have an excessive amount of inflammation in their fat tissues,~     and whether this inflammation comes from the bacteria in their intestines. To determine~     this, the investigators wish to treat individuals with an antibiotic that reduces the~     bacteria in their intestines and in their blood, and determine whether this reduces their~     overall level of inflammation.~   "
71280|NCT02124499|"~     Prospective association study to analyse perioperative patients' outcome. Outcome comprises~     intraoperative and postoperative complications e.g. cardio-vascular events, allergic~     reactions, postoperative side-effects like nausea and vomiting, impaired wound healing,~     increased or decreased drug effects, severe pain, long-lasting pain as well as long-term~     outcome.~      Possible variables which might have on influence: patient- and surgery-related data,~     patients' genetic background etc.~   "
71281|NCT02124486|"~     Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes.~     The condition is associated with raised pressure in the brain and can cause disabling daily~     headaches and loss of sight, which can be permanent. The raised brain pressure squashes the~     nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90%~     of patients with IIH are overweight and weight loss is the most effective treatment. Other~     treatments for IIH have very little current evidence to support their use.~      Weight loss is difficult to maintain. This trial aims to compare two methods of weight loss,~     bariatric surgery and the most effective dietary programme commonly available, Weight~     Watchers, to see which offers the most effective sustainable treatment for IIH. Bariatric~     surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index~     (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on~     average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery.~      This trial will recruit 60 women with IIH from the Queen Elizabeth Hospital Birmingham, a~     major UK IIH centre. They will be randomised and 30 participants will be allocated to the~     dietetic intervention arm, and be enrolled in their local Weight Watchers group. 30~     participants will be allocated to the bariatric surgery arm, and will be referred to the~     Birmingham Heartlands Hospital bariatric surgery pathway to receive bariatric surgery. Both~     groups of participants will be allocated to a treatment arm which is proven to bring about~     weight loss.~      Participants will then be followed up for five years, with the most important measurement~     being their brain pressure after one year of being in the trial.~      A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline~     symptoms and biomarkers of those with IIH; they will take no further part in the study. 5~     further healthy individuals will be scanned twice in an MRI test group to validate the MRI~     scan sequence to be used in the trial.~   "
71282|NCT02124473|"~     Resistant hypertension (RHTN) is a common clinical problem faced by both primary care~     clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular~     events and mortality compared with patients with more easily controlled hypertension. In~     addition, RHTN is often complicated by metabolic abnormalities.~      Homeopathy, although widely used in hypertension, but no study has been taken to evaluate~     the impact on resistant hypertension. The aim of this trial was to evaluate individualized~     homeopathy on BP in patients with resistant hypertension.~   "
71341|NCT02123693|"~     The aim of the present study is to determine whether there is a relationship between~     osteopathic treatment and the change of physiological axes of the lumbar spine, through the~     use of Dynamic Magnetic Resonance Imaging.~   "
71393|NCT02122861|"~     This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of~     ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel~     immunotherapy agent designed to target dendritic cells and stimulate the body's immune~     system to fight the spread and growth of cancer for patients whose tumors express the~     NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer~     that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating~     ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to~     anti-PD-1 therapy.~   "
71283|NCT02124460|"~     Health care system (HCS)-based interventions have been limited by their inattention to~     social and environmental barriers that impede improvement in obesity-related behaviors.~     Additionally, current pediatric obesity care delivery relies on an outdated provider:patient~     paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the~     organizational structure to provide longitudinal care for children with chronic illnesses,~     the clinicians to manage and support patients with chronic illnesses outside of clinic,~     and/or the health information systems that support the use of evidence-based practices at~     the point-of-care. Thus, the research question this study is designed to address is whether~     a novel approach to care delivery that leverages delivery system and community resources and~     addresses socio-contextual factors will improve family-centered childhood obesity outcomes.~      The primary specific aims are to examine the extent to which the intervention, compared to~     the control condition, results in:~        1. A smaller age-associated increase in BMI over a 12-month period.~        2. Improved parental and child ratings of pediatric health-related quality of life.~      The secondary aims are:~        1. To examine parental ratings of quality and family-centeredness of pediatric obesity~          care and compare outcomes among participants in the intervention with the control~          condition~        2. To assess change in weight-related behaviors and compare outcomes among participants in~          the intervention with the control condition~        3. To assess the following process measures:~             -  Reach~             -  Extent of implementation~             -  Fidelity to protocol~             -  Parent satisfaction~        4. To examine the extent to which neighborhood environments modify observed intervention~          effects~        5. To assess the documentation of Healthcare Effectiveness Data and Information Set~          (HEDIS) measures in participant medical records~   "
71284|NCT02124447|"~     This will be a 4-way comparison to prospectively evaluate the efficacy and patient~     tolerability of four commercially available bowel preparations among patients undergoing~     colonoscopy for screening and surveillance in a single tertiary academic medical center.~   "
71285|NCT02124434|"~     Surgery is considered the best therapy for morbid obesity and its comorbidities, where~     alterations in lifestyle, diets and drugs have failed to achieve weight loss. The most~     widely performed in Israel is Laparoscopic Sleeve Gastrectomy (LSG), and several studies~     have reported high success rates in reducing weight and improving comorbidities common among~     obese patients such as hypertension; diabetes mellitus type II; dyslipidemia;~     osteoarthritis; obstructive sleep apnea etc.~      The hypothesis of this prospective study is that the LSG is an effective treatment for~     achieving weight loss, for improving and even curing comorbidities and for improving the~     patient's QOL. Another supposition is that patient's socio-economic status can influence~     success rates of bariatric procedures.~   "
71286|NCT02124421|"~     Community hospital based phase II (prospective randomized) study to evaluate the toxicity of~     cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly~     diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian~     tube, and primary peritoneal cancer.~   "
71287|NCT02124408|"~     With the development of economy and change of lifestyles, it is characterized that there is~     a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by~     diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile~     phone intervention was a kind of high cost efficiency and high quality health care. Our~     study evaluated a diabetes coaching system, using mobile phones and patient/provider portals~     for patient-specific treatment and communication.~   "
71288|NCT02124395|"~     Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney~     Stone Consortium~   "
71289|NCT02124382|"~     Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal~     vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.~   "
71290|NCT02124369|"~     Pancreatic cancer is difficult to treat, and even in a situation where an operation can be~     performed to remove the cancer, the disease can unfortunately come back soon afterwards.~     When pancreatic cancer is more advanced, the outcomes are even less positive. Recently, a~     large international study showed that combining a chemotherapy drug that is standard for~     treating pancreatic cancer, called gemcitabine with a new chemotherapy drug called Abraxane~     was more effective than gemcitabine alone for patients with advanced pancreatic cancer.~      The purpose of this study is to determine whether this combination of gemcitabine and~     Abraxane can shrink a pancreatic cancer that is not thought to be operable enough to enable~     it to be removed by surgery. It is hoped that in this way, the treatment may improve the~     outcome. In addition, in this study we would like to analyse the appearances of the tumour~     using imaging, and collect blood and tumour samples to try to confirm laboratory research~     that has been carried out with this treatment.~   "
71291|NCT02124356|"~     Emergency abdominal surgery is associated with high mortality rates, multiple postoperative~     complications and prolonged duration of hospital admission. The purpose of this study is to~     examine the postoperative functional performance in patients undergoing Emergency High-risk~     Abdominal Surgery. The hypothesis is that the study can describe the patient population in~     relation to postoperative functioning, degree of inactivity and the factors that limit~     mobility.~   "
71292|NCT02124343|"~     Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic~     Obstructive Pulmonary Disease (COPD). Although researchers have shown numerous benefits with~     exercise in COPD patients, most studies have only looked at exercise tolerance and~     psychological outcomes following training. COPD is characterised by persistent inflammation~     that can cause progressive decline in lung function and multisystemic complications. This~     inflammation can be amplified in patients when they suffer acute exacerbations. There is a~     wellknown relationship between exercise, immune function and risk of infection. Exercise has~     also been shown to have an antiinflammatory effect when performed regularly. There is a lack~     of research looking into the inflammatory or immune response to exercise in patients with~     COPD. The exercise within this study will be individually tailored to patients with COPD~     based on their validated 6 minute walk test (6MWT) but the protocol will involve interval~     exercise that has been used previously. This type of exercise is considered most appropriate~     for research into mechanisms of benefit because it maintains the exercise training effects~     of other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the~     occurrence of limitations to exercise in people with lung problems (e.g. dynamic~     hyperinflation). It also closely mirrors daily activity of someone with COPD.~      The investigators want to explore the effects of exercise specifically on immune function in~     15 people COPD and compare any changes to 15 Controls. By better understanding the~     mechanisms of how exercise affects inflammation, the investigators could eventually design~     better Pulmonary Rehabilitation interventions, especially for those most at risk.~   "
71293|NCT02124330|"~     Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical~     properties, such as swelling and cation exchange capability.~      The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to~     reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability~     of immobilizing proteins.~   "
71295|NCT02124304|"~     Cervical pain is a condition that affects 14.6% of all adults annually. Of this annual~     prevalence, 37.3% experience persistent neck pain with periodic recurring episodes. The~     purpose of this study is to compare muscle activation patterns of the cervical musculature~     during exercises with elastic versus manual resistance in a neck pain and asymptomatic~     populations. Methods: A convenience sample of 15 healthy, physically active participants and~     15 current patients diagnosed with non-radicular cervical pain will be recruited.~     Exclusionary criteria will include: current cervical or upper extremity injury (healthy~     group), history of neck surgery, corticosteroid treatment within the last two weeks, and~     radicular signs or symptoms. Surface electromyography will be used to quantify the activity~     level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT)~     muscles while performing a series of 6 exercises with elastic resistance using Thera-Band®~     Resistance Bands and manual resistance. The area will be prepped and surface electrodes~     placed on the corresponding muscles. The movement will be standardized by using the peak~     activation (PA) of each muscle during full flexion-extension movement to create a percentage~     of peak activation (%PA). The testing battery will consist of 6 exercises with elastic~     resistance and manual resistance, totaling 12 different trials. Each trial will involve 5~     repetitions, each held for 5 seconds. The exercises will include cervical: extension,~     flexion, left rotation, right rotation, left side bending, and right side bending. The men~     will use the green and women will use the red Thera-Band® Resistance Band. The order of~     exercises will be randomized in to two parts to minimize the effect of fatigue. First,~     cervical flexion and extension with manual and elastic resistance will be randomized.~     Secondly, the remaining 8 exercises will be randomized. Following each exercise, the patient~     will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale~     for Exercise (RISE).~   "
71296|NCT02124291|"~     The objective of study is to assess the possible impact of assisted hatching on the~     implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human~     embryos.~   "
71297|NCT02124278|"~     The purpose is to determine if single doses of PUL-042 inhalation solution are safe in~     healthy subjects.~   "
71298|NCT02124265|"~     In patients with moderate to severe thermal injuries (> 20% TBSA) adequate fluid~     resuscitation is the main priority to achieve successful outcomes. Soon after burn injury~     substantial amounts of fluid accumulate rapidly in the wound while more is lost in the third~     space. Without intervention this process leads to hypotension and shock. The Parkland~     formula was devised to calculate how much intravenous (IV) fluid, i.e. crystalloids, is~     needed for adequate resuscitation during the first 24 hours post-burn. However, IV~     resuscitation can lead to overexpansion of (third space) volume, leading to severe~     complications such as compartment syndrome or pulmonary edema.~      In major population centers, catastrophic events causing mass casualties will disrupt many~     hospital and emergency services, potentially delaying acute IV fluid resuscitation. Burn~     patient case reports have shown that oral rehydration therapy (ORT) used to supplement or in~     place of IV therapy is efficacious. ORT could be easily applied in mass burn casualties.~      ORT is generally known in the third world for treating life-threatening dehydration due to~     diarrhea. The glucose-sodium co transport mechanism enables the affected human intestine to~     absorb a sufficient amount of water and electrolytes to replace large fluid losses due to~     severe diarrhea, even under adverse field conditions. No electrolyte disturbances have been~     recorded in such cases. Studies on enteral resuscitation in animal burn models showed high~     rates of small intestinal absorption which should be adequate for resuscitation following~     major burn injury.~      The optimal composition of oral rehydration solution for resuscitation in burn wounds has~     not been determined. In cholera patients, Ceralyte® has proven superior to the WHO Oral~     Rehydration Solution, increasing fluid absorption of the intestine. The Ceralyte® 90~     solution, with 90mEq/L sodium and a low osmolarity of <275mOsm, may also contribute to~     optimal intestinal fluid uptake without causing electrolyte disturbances in thermal injury.~     ORT use might reduce the occurrence of compartment syndrome and pulmonary edema since fluid~     is regulated by the intestine according to physiologic requirements. The investigators~     propose to conduct a prospective study using Ceralyte® 90 to show that oral resuscitation~     therapy (ORT) in burns can reduce the total amount of IV fluid needed for adequate~     resuscitation and to test the efficacy and safety of ORT in the resuscitation of burn~     patients.~   "
71299|NCT02124252|"~     There are many challenges to implementation of cervical cancer prevention in~     resource-limited countries, despite evidence based screening and treatment strategies. The~     investigators hypothesize that self-collected HPV specimens offered in a community health~     campaign setting will~   "
71300|NCT02124239|"~     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel~     groups will be enrolled. The trial includes three active treatment groups.~      To be eligible for inclusion in this trial, subjects must have at least 10 clinically~     typical, visible, and discrete AKs on the face, balding scalp or on the arm within a~     contiguous area of approximately 250 cm2 of sun-damaged skin.~      There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027%~     on the full face for three consecutive days, (2) the same regimen on the balding scalp, and~     (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of~     approximately 250 cm2 for four consecutive days.~   "
71301|NCT02124226|"~     Patients with chronic severe asthma (CSA) have a crippling disease and current available~     treatments are not satisfactory. Thus, management of CSA remains a major unmet need.~     Although the evidence from existing randomized controlled trials fails to support a definite~     role for immunomodulatory drugs in these patients due to major methodologic drawbacks,~     findings with low-dose methotrexate (MTX) are encouraging. However, larger and well designed~     clinical trials are required to establish the beneficial role of MTX in CSA and for the~     detection of the key characteristics of those who are going to respond to this drug.~      This study will be the first multi-centre RCT investigating the role of an add-on~     immunological modifier as a clinically useful therapeutic strategy in patients with~     well-phenotyped chronic severe asthma. As such, this study does not overlap with any other~     research currently ongoing.~   "
71302|NCT02124213|"~     This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562~     In healthy male volunteers~   "
71303|NCT02124200|"~     E-cigarettes are proving to be an attractive long-term alternative to conventional~     cigarettes. Although they may also help smokers to remain abstinent during their quit~     attempt, recent clinical trials with first generation e-cigarettes have shown only modest~     quit rates. Second generation devices may result in much higher quit rates. Their efficacy~     and safety in long-term smoking cessation and/or smoking reduction studies have never been~     investigated.~      In this prospective proof-of-concept study we monitored modifications in smoking habits of~     50 regular smokers (unwilling to quit) who were asked to switch to a second generation~     device focusing on smoking reduction and smoking abstinence. Study participants were invited~     to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24.~     Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were~     measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse~     events and participants' opinions of these products were also reviewed.~   "
71354|NCT02123524|"~     This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre~     trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg~     Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with~     anticoagulant therapy.~   "
71394|NCT02122848|"~     The purpose of this study is to evaluate the effects of airway bilevel positive pressure on~     the improvement of exercise tolerance in patients with decompensated heart failure.~   "
71395|NCT02122835|"~     The purpose of this study is to understand the differences in how patients with heart~     failure respond to exercise training compared to patients with heart failure and type 2~     diabetes.~   "
71304|NCT02124187|"~     It is well established in studies across several countries that tobacco smoking is more~     prevalent among depressed patients than the general population. Electronic cigarettes are~     becoming increasingly popular with smokers worldwide. To date there are no large randomized~     trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to~     compare efficacy and safety of these products in this special population.~      We have designed a randomized controlled trial investigating the efficacy and safety of~     electronic cigarette. The trial will take the form of a prospective 12-month randomized~     clinical study to evaluate smoking reduction, smoking abstinence and adverse events in~     depressed smokers not intending to quit. We will also monitor quality of life,~     neurocognitive functioning and measure participants' perception and satisfaction of the~     product.~      Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be~     calculated at each study visit (reducers). Abstinence from smoking will be calculated at~     each study visit (quitters). Smokers who leave the study protocol before its completion~     and will carry out the Early Termination Visit or who will not satisfy the criteria of~     reducers and quitters will be defined non responders.~   "
71305|NCT02124174|"~     Phase II trial combining azacitidine with valproic acid as maintenance therapy post~     allogeneic stem cell transplantation in patients with high-risk MDS/AML. We hypothesize that~     adding valproic acid to azacitidine will improve outcomes via both direct anti-tumor and~     immunologically mediated antitumor response with alloreactive donor lymphocytes, having an~     additive effect and extending 1 year survival in patient with high-risk AML/MDS after~     hematopoietic stem cell transplant. Based on aforementioned data from the US Department of~     Health and Human Services, standard 1 year survival for AML after stem cell transplant is~     near 40%. We hypothesize that valproic acid and azacitidine will prolong survival, with a 1~     year survival goal of 60%. In addition to assessing for 1 year survival, we will have~     secondary objectives of assessing progression-free survival, relapse, and toxicity. The~     primary toxicity endpoint from this will be cytopenias and infections.~   "
71306|NCT02124161|"~     The purpose of this study is to evaluate the immunogenicity and safety of 13-valent~     pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated~     influenza vaccine to adults 50 years and older who have previously received 23-valent~     pneumococcal polysaccharide vaccine.~   "
71307|NCT02124148|"~     The main purpose of this study is to investigate the safety of prexasertib in combination~     with other anti-cancer drugs (cisplatin, cetuximab, pemetrexed, fluorouracil or LY3023414)~     in participants with advanced cancer or cancer that has spread to another part of the body.~     The study has multiple parts (A, B, C, D and E). Participants will only enroll in one part.~   "
71308|NCT02124135|"~     Dietary counseling at the point of purchase could improve patient adherence to dietary~     advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a~     novel delivery system for dietary advice. We will study the effect of relocating family~     weight management counseling sessions into restaurants, where registered dieticians and~     patients will conduct scheduled group visits while enjoying a meal together. As with~     office-based visits, our goal is for members and their families to learn how to select food~     options based on their unique health needs, budgetary concerns, and time constraints. In~     contrast to a traditional counseling visit, however, co-dining with a dietitian will give~     members a hands-on experience designed to enhance their learning and improve adherence. The~     proposed study would build on an existing pilot of a similar program, the KP Personal~     Shopper, where dietitian visits were conducted with individuals either in the clinic~     setting or while shopping in a grocery store.~      We will compare the new Eat Out with Kaiser approach to the current standard of~     clinic-based dietary and lifestyle counseling for weight management among 40 families~     affected by obesity, with the following outcomes in mind:~        1. Change in dietary measures~        2. Nutritional knowledge of families~        3. Participant self-efficacy and confidence in food purchasing decisions~        4. Participant and dietician perception of visit~      We hypothesize that, compared to clinic-based visits, our Eat Out with Kaiser visits will~     result in more favorable perception of the visit by both dietitian and participant, higher~     nutritional knowledge scores, higher self-efficacy and confidence of patients around food~     decisions, and larger improvements in diet components.~   "
71309|NCT02124122|"~     This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr)~     strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a~     clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric~     diarrhea in Peru.~   "
71310|NCT02124109|"~     Background:~      - An acquired heart disease is one that a person gets after they are born. Two of these are~     rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more~     commonly in people who live in Africa than in other places in the world. Researchers want to~     learn more about these diseases. They especially want to know what role genes and other~     factors play in them.~      Objective:~      - To identify genetic risk factors for RHD and EMF in sub-Saharan Africa.~      Eligibility:~        -  Children and adults with RHD or EMF.~        -  Healthy volunteers over age 10.~      Design:~        -  Participants will come from existing study groups in Uganda and Nigeria.~        -  Participants may be required to provide a sample of their DNA. They will do this with~          either a blood or saliva sample or a swab of the mouth.~        -  Collected samples will be labeled with a code and sent to a lab in the United States~          for analysis. Remaining portions of participants samples will be stored for an~          unlimited period of time. They may be used in future studies.~        -  Some genetic and health information from participants might be placed into one or more~          scientific databases.~        -  Participant names and identifying information will be kept private. But there is a~          small chance someone could trace them from their genetic information.~   "
71355|NCT02123511|"~     This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen~     saliva thickness and painful mouth sores in patients with head and neck cancer undergoing~     radiation therapy. Side effects from radiation therapy to the head and neck, such as~     thickened saliva and mouth sores, may interfere with activities of daily living such as~     eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine~     rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients~     with head and neck cancer undergoing radiation therapy.~   "
71311|NCT02124096|"~     Background:~      - The flu is a very infectious and contagious virus that affects both people and pigs.~     Studies show that pigs can be sources of the flu virus in humans. Researchers want to know~     more about how the flu is transmitted from animals to people. If they know more about it,~     they can find better ways to prevent the flu and treat people who get sick from it.~      Objective:~      - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural~     fairs.~      Eligibility:~      - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs.~      Design:~        -  Before or on the first day of the fair, participants will fill out a short demographic~          and medical history form. They will also complete a two-page symptom questionnaire.~          This is a form that asks them about any flu symptoms they might have.~        -  Participants will have a nasal swab performed. The inside of the participant s nose~          will be rubbed with a swab to collect nasal fluid.~        -  Researchers will see participants 2 days later and 4 days later. During these visits,~          participants will again fill out a symptom questionnaire and have a nasal swab.~   "
71312|NCT02124083|"~     Niemann-Pick disease type C (NPC) is a lethal, autosomal recessive, lysosomal storage~     disorder characterized by neurodegeneration in early childhood and death in adolescence. The~     causative genes NPC1 (about 95% of cases) and NPC2 (about 5% of cases) are involved in the~     intracellular trafficking of lipids and cholesterol. Mutations on either of these genes lead~     to progressive accumulation of unesterified cholesterol and other lipids in the central~     nervous system (CNS). Vorinostat is a histone deacetylase inhibitor that has been shown in~     vivo to increase mutant NPC1 protein levels and to reverse cellular accumulation of~     unesterified cholesterol. Vorinostat has been labeled by the FDA for treatment of cutaneous~     T-cell lymphoma. In this Phase I, non-randomized, open-label, single-center study, we plan~     to study whether Vorinostat can be repurposed to treat patients with NPC1. Our primary~     objective is to determine the safety and tolerability of Vorinostat in NPC1 disease. Our~     secondary objectives will be to determine biochemical efficacy of Vorinostat to increase~     expression of NPC1 protein and normalize lipid and protein biomarkers. This study will~     enroll up to 12 NPC1 patients and test the safety of two dose levels (200 and 400 mg). Drug~     will be administered on a 3 days on/4 days off schedule for 3 months at each dose level.~     Patients will be evaluated at the NIH Clinical Center at 0, 3 and 6 months. Safety will be~     assessed by adverse events (AEs), clinical laboratory tests and physical examinations.~     Biochemical efficacy will be assessed by measurement of serum and cerebral spinal fluid~     biomarkers. Clinical efficacy will be evaluated by audiologic testing, assessment ataxia,~     and swallowing studies.~   "
71313|NCT02124070|"~     Background:~      -(Degree)ystinosis is an inherited disease. If not treated correctly, it can cause muscle~     wasting and weakness and kidney damage. Researchers want to learn if growth hormone (GH) can~     help people with cystinosis.~      Objective:~      - To learn if GH treatment can slow or reverse muscle wasting and improve muscle strength in~     people with cystinosis.~      Eligibility:~      - People 18 and older who are already enrolled in protocol 78-HG-0093.~      Design:~        -  Participants will be admitted to the clinic for eight 3 4 day visits, mostly four~          months apart.~        -  At each visit, participants will have a history and physical exam and give urine and~          blood samples.~        -  At month 0 or 13, participants will take tests that will be repeated at their 12- or~          25-month visit:~        -  They will have an eye exam, medical consultations, and strength and movement tests.~        -  They will complete questionnaires.~        -  They may have tests of heart activity and lung function.~        -  They will have ultrasound imaging of their arm and hand muscles. They will have a scan~          of their legs while lying in a magnetic resonance imaging machine (a big metal~          cylinder). They will have a DEXA bone scan (two X-ray beams measure body composition).~          They will also swallow barium while X-ray imaging records the throat muscles.~        -  Participants will be randomly assigned to either receive or not receive GH for the~          first 12 months. Then, at month 13, if they received GH, they will switch for the next~          12 months.~        -  Participants will take GH as a daily injection. They will be taught how to give the~          injections.~   "
71314|NCT02124057|"~     Background:~      - Spinal and bulbar muscular atrophy (SBMA) is an inherited disease. It causes weakness in~     muscles used for swallowing, breathing, and speaking. SBMA mainly affects men, but women can~     carry the gene for it. Researchers think there may be a link between SBMA and excess fat in~     the liver.~      Objective:~      - To look for fatty liver and liver injury in people with SBMA, people with motor neuron~     disease, and people who carry the gene for SBMA.~      Eligibility:~        -  Adults 18 years and older who have SBMA, have motor neuron disease, or are carriers of~          SBMA.~        -  Healthy adult volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have 1 outpatient visit of 1-2 days. Women will have a urine~          pregnancy test. All participants will have:~        -  Blood tests.~        -  Liver ultrasound. A probe is placed on the abdomen at certain locations and angles and~          takes pictures. The painless procedure takes 20-30 minutes.~        -  Liver magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder with a~          magnetic field. Participants will lie on a table that slides in and out of it. They~          will be in the scanner for about 30 minutes. They will get earplugs for loud noises.~        -  Some participants with abnormal liver testing will have a biopsy (small piece) of the~          liver taken. The biopsy site will be located with ultrasound, then cleaned and numbed.~          The physician will quickly pass a needle in and out of the liver while the participants~          holds their breath. Afterward, participants will be monitored in bed for 6 hours.~        -  Participants may return for follow-up and another 1-2 day outpatient visit yearly for~          up to 2 years.~   "
71356|NCT02123498|"~     The purpose of this study is to investigate the relationship between ear fullness, pressure,~     and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve~     therapeutic outcomes in this patient population.~   "
71357|NCT02123342|"~     The purpose of the study is:~      1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an~     health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized~     controlled trial (RCT).~      Hypothesis: Frequency and duration of the exercise programme execution will be higher for~     the SMS reminder condition compared to the programme only condition. The effect may be~     reduced from post- to follow-up measurement (24 weeks after baseline and 12 weeks after~     post-measurement) but all outcomes will remain significantly higher at 24 weeks.~   "
71315|NCT02124044|"~     Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated~     180 million people infected worldwide. In the United States an estimated 4.1 million people~     are infected and HCV is the principal cause of death from liver disease and leading~     indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due~     to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and~     pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently~     recommended therapy for chronic HCV infection and has superior cure rates compared to~     PEG+RBV alone in HCV monoinfected patients, treatment is still associated with a high~     incidence of adverse events (AEs), discontinuations and poor cure rates in several~     populations. Within the HIV/HCV co-infected population treatment for HCV remains complicated~     given drug interactions between anti-retrovirals and HCV protease inhibitors, in addition to~     the extensive side-effects due to PEG +RBV alone. Recent studies have demonstrated that the~     use of a combination of anti-virals which target HCV without interferon (IFN) can cure HCV,~     without additional toxicities. These novel therapies that do not rely on an IFN backbone may~     additionally enhance cure rates in HIV/HCV co-infected, a population which has historically~     been difficult to cure.~      This is an open label study to assess the safety, tolerability and efficacy of asunaprevir~     (ASV) 100 mg BID and daclatasvir (DCV) 60 mg daily (selective HCV NS3 and NS5A inhibitors~     respectively) in 20 HIV/HCV co-infected treatment-na(SqrRoot) ve and treatment experienced~     HCV genotype 1b individuals.~      The findings from this study will aid in the understanding of antiviral and host responses~     and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.~   "
71316|NCT02124031|"~     The purpose of this study is to evaluate quality of life, degree of disability, treatment~     patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in~     Mexico.~   "
71317|NCT02124018|"~     The purpose of the study is to assess the prevalence and the prognostic value of~     non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in~     post-MI patients with LVEF >40%.~   "
71318|NCT02124005|"~     The purpose of the study is to determine the minimum effective concentration of bupivacaine~     (EC50) in femoral block for analgesia by ultrasound after knee surgery.~   "
71319|NCT02123992|"~     The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical~     and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in~     a controlled, post-market cohort study.~   "
71320|NCT02123979|"~     Narcotics are widely used as the mainstay of pain treatment, although increasing doses are~     required over time as the individual becomes tolerant to their effects. This can lead to the~     development of dependence and abuse of these drugs. Research has identified a new way to~     decrease the risk of developing tolerance to narcotics, by giving at the same time a drug~     called rotigotine (Neupro). Rotigotine interferes with the body's chemical dopamine and is~     FDA-approved for the management of Parkinson's Disease.~      The purpose of this research study is to look at side effects and pain control in healthy~     people after removal of wisdom teeth, which usually causes pain. It is thought that by~     giving the study drug rotigotine with the narcotic pain reliever, there will be pain control~     that will extend longer than when giving the narcotic alone.~   "
71321|NCT02123966|"~     This research study is evaluating the effectiveness of topical sirolimus combined with~     topical steroid therapy, as a possible treatment for oral cGVHD.~   "
71322|NCT02123953|"~     The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438~     following multiple oral doses to healthy adult Japanese male participants~   "
71323|NCT02123940|"~     Prospective, randomized clinical multicentric study in ICU during weaning from mechanical~     ventilation.~   "
71324|NCT02123927|"~     The primary purpose of this study was to evaluate the single dose safety and~     pharmacokinetics of TAK-438 in healthy Japanese men.~   "
71325|NCT02123914|"~     1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients~          with allergic rhinitis~        2. Moderate exercise training combined with vitamin C supplementation decrease cytokine~          response and rhinitis symptoms in patients with allergic rhinitis~        3. Moderate exercise training combined with vitamin C supplementation has more beneficial~          effects than moderate exercise training alone for decreasing cytokine response and~          rhinitis symptoms in patients with allergic rhinitis~   "
71326|NCT02123901|"~     Walking Meditation training would yield more favorable adaptations than walking alone in~     improving glycemic control and vascular function in patients with type 2 diabetes.~   "
71327|NCT02123888|"~     The cone beam image is a part of the radiotherapy treatment machine and uses lower energy~     xrays as the head of the radiotherapy machine moves around the patient in a circle. This~     takes pictures that give 3-dimensional information, somewhat like a CT scan. These images~     are better at showing the position of the tumour and surrounding soft tissues than the~     standard xrays that were previously used. Cone Beam Imaging Technology is not new and has~     been used regularly at The Christie for many years. The standard cone beam scan is taken~     before the actual radiotherapy treatment or after the treatment has been delivered.~      Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering~     radiotherapy that involves the continuous movement of the radiotherapy treatment machine~     head around the patient and MLC during radiation. Arc radiotherapy has been clinically~     implemented at The Christie for prostate radiotherapy treatments and work is in progress for~     implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT~     delivery makes this simultaneous imaging possible, although there are concerns associated~     with the impact that this may have on patient dose and image quality.~      The aim of this research is to assess whether the image quality of cone beam scans taken~     during treatment are as good as standard cone beam scans taken before or after treatment~     used to determine the accuracy of patient position and the tumour coverage by radiotherapy.~   "
71328|NCT02123875|"~     ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model~     which proves to offer several advantages in low and mid income countries. The objectives of~     the pilot stude were to determine that with a randomized blinded outcome assessor,~     controlled trial, family- led caregiver- delivered home based rehabilitation is better than~     usual care for those with disabling stroke in India and the feasibility of this model.~   "
71329|NCT02123862|"~     The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before~     and after treatment using an experimental method for detecting CTC, compared to commercial~     CTC assay results, in patients with prostate, breast or colorectal cancers.~      Experiments will be done to develop a new assay technique and also test how CTC react to~     commonly used drugs. This information will be analyzed to determine if the experimental~     assays can be helpful in the future to predict how a patient's cancer may react to certain~     treatments.~      The research experiments will also attempt to grow CTC for long-term or immortal cell~     lines that can be further studied for proteins and gene mutations related to the specific~     tumor (not familial), and testing for sensitivity to drugs.~      Blood samples will be collected at specific time points during routine medical care from~     patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be~     collected from patients with no cancer for comparison purposes. Samples for the experimental~     tests will be identified only by codes and results will not be shared with participants.~     Patients with prostate, breast or colorectal cancer will also have blood samples drawn for~     commercial CTC assays as part of their standard care.~   "
71330|NCT02123849|"~     This randomized phase II trial studies the safety and effects of acetylsalicylic acid~     (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of~     current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic~     acid may be useful in preventing lung cancer.~   "
71331|NCT02123836|"~     A novel method has been developed to expand natural (NK) cells and enhance their~     cytotoxicity against cancer cells while maintaining low killing capacity against~     non-transformed cells. In this method, donor NK cells are expanded by co-culture with the~     irradiated K562 cell line modified to express membrane bound IL-15 and 41BB ligand~     (K562-mb15-41BBL). Expression of these proteins in conjunction with unknown stimuli provided~     by K562 cells promotes selective growth of NK cells. Then, the expanded NK cell population~     is depleted of T cells to prevent graft versus host disease (GVHD). Expanded and activated~     NK cells showed powerful anti-leukemic activity against acute myeloid leukemia (AML) cells~     in vitro and in animal models of leukemia.Unpublished laboratory results also demonstrated~     that T-cell acute lymphoblastic leukaemia (T-ALL) is extremely sensitive to the cytotoxicity~     exerted by the expanded and activated NK cells.~      The present study represents the translation of the laboratory findings into clinical~     application. The study proposes to determine the feasibility, safety and efficacy of~     infusing expanded NK cells into patients who have AML or T-lineage ALL which is resistant to~     standard therapy as demonstrated by persistent minimal residual disease (MRD). Patients with~     myelodysplastic syndrome (MDS), who are at high risk to develop AML will also be eligible~     for the study. In this patient cohort, the study will also investigate the in vivo lifespan~     and phenotype of the expanded NK cells.~      The main hypothesis to be tested in this study is that infusion of expanded activated NK~     cells can produce measurable clinical responses in patients with AML or T-ALL.~   "
71332|NCT02123823|"~     Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose,~     and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in~     combination with exemestane in women with HR+/HER2- advanced breast cancer~   "
71333|NCT02123810|"~     The investigators sought to evaluate the influence of fatigue after a night shift on the~     quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.~   "
71334|NCT02123797|"~     Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths.~     The overall year survival rate has only improved from 12% to 17% in 33 years. This failure~     reflects the innate lethality of lung cancer, but also reflects defects in patient care~     delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds~     through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage),~     selection of appropriate treatment, and finally ends with patient outcomes. At each step are~     multiple options and independent specialists, each one engaged by a process of sequential~     referrals in the serial care model. This process is often not user-friendly, is riddled with~     inefficiency, delays, and outcome variances.~      The coordinated multidisciplinary model, in which patients and their doctors collaborate to~     provide evidence-based care, is believed by experts to be superior, but has few examples of~     successful implementation. The implementation gap exists because of the paucity of good~     quality data, and lack of implementation know-how.~      Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a~     racially, culturally, economically and geographically diverse population. The investigators~     research group has shown how poor quality care impairs patient survival in this region and~     in the greater US. The investigators have linked patient survival to compliance with~     multidisciplinary care plans. In this project, the investigators propose to rigorously test~     the impact of the multidisciplinary care model on patient outcomes in a community-based,~     private practice environment, similar to where 70% of lung cancer care is delivered in the~     US.~      The objective of this study is to provide high-level evidence of the impact of~     multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as~     a model of care in which patients, their care-givers and key specialists concurrently and~     directly evaluate the same patients in the presence of the patients and their informal~     caregivers, in order to develop evidence-based consensus care plans~   "
71335|NCT02123784|"~     Identification of biomarkers that can predict the outcome of the surgical treatment (i.e.~     the rate of re-rupture) of tears in the rotator cuff tendon.~   "
71336|NCT02123771|"~     The investigators hypothesis:~      Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.~   "
71337|NCT02123758|"~     The purpose of this study is to investigate potential drug-drug interaction (DDI) between~     JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine~     safety of the combination and evaluate in a descriptive manner the efficacy in these~     participants. It will also, potentially provide dosing recommendations for abiraterone~     acetate in future studies when combined with JNJ-56021927.~   "
71338|NCT02123745|"~     A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of~     the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV~     therapy.~   "
71339|NCT02123732|"~     This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks~     of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in~     patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but~     less than 8.0% on their current conventional therapy.~   "
71340|NCT02123719|"~     Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.~      Study group: Patients with incisional hernia post liver transplantation Control group:~     Patients with incisional hernia post any other laparotomy in the upper quadrant.~      Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome~     parameters: - Hernia repair-related infection rate~      - Postoperative morbidity Statistical analysis: Comparison of study versus control group,~     univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were~     considered significant.~   "
71342|NCT02123680|"~     Non-specific chronic low back pain guidelines recommend rehabilitation along with a~     biopsychosocial approach. However, though psychological and social issues address important~     needs of professionals and patients, they have been scarcely developed in this area so far.~     Noteworthy, little is known about patients' expectations relative to physiotherapy for~     chronic low back pain (CLBP), while professional recommendations advocate taking them into~     consideration.~      A study about patients' experience will provide knowledge about the ill person's perspective~     and how the physiotherapists are perceived as well as the role attributed to them. The aim~     of this study is, thus, to explore the experience of the patients suffering from CLBP in~     order to highlight their expectations toward physiotherapy services and physiotherapists.~      The investigators will apply a critically interpretive socio-anthropological approach based~     on patients' interviews and observations in an intensive CLBP rehabilitation program. The~     results will help improve the care patients receive by facilitating the integration of~     biopsychosocial issues related to patient's expectations into the treatment.~   "
71343|NCT02123667|"~     Multinational, multicentre, non-pharmacological intervention, cross-sectional and~     longitudinal study.~   "
71344|NCT02123654|"~     The purpose of this study is to demonstrate that the proportion of treatment-naive~     non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir~     (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C~     virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week~     12, is significantly higher than SVR12 of current Standard of Care (SOC).~   "
71345|NCT02123641|"~     A minimum of 450 healthy individuals (62-70 years old) will be recruited.~      Each individual will be randomized into one of three groups stratified according to gender~     (M/F), BMI (≤28/>28), and 30 sec chair stand (≤11/>11). The three groups are Heavy~     resistance training (n=150), moderate intensity training (n=150), and control (n=150, no~     training).~      Assessments will be performed at baseline, after 12 months of intervention. Furthermore,~     follow up will be performed after 2,4,7, and 10 years.~      The primary outcome is change in leg extensor power after the intervention and during follow~     up.~      The primary hypothesis is that by applying the intention-to-treat analysis, the moderate~     intensity training group will increase leg extensor power just as much as the heavy~     resistance training group. The two training groups will increase muscle power more than the~     control group.~   "
71346|NCT02123628|"~     The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week~     antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.~   "
71347|NCT02123615|"~     ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of~     injectable products to it's optimum/right spot, just outside of the fascia, which exists~     subdermally (between the skin and muscle). Bloodless basically implies longer lasting~     medicinal effects, and minimal side effects - advantages that reflect the NIH mission of~     enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS~     device is stabilized on the surface of the skin with negative pressure and emits an~     electrical current to create a bloodless cavity subdermally. ASIS device correctly,~     automatically, and consistently delivers therapeutic agents, yet requiring little skill of a~     practitioner - providing the steady and safe infusion into subdermal bloodless space of~     virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel,~     Insulin, and Fillers, etc. According to the FDA, This innovation will have major impact on~     the healthcare industry.~   "
71348|NCT02123602|"~     The investigators hypothesize that the use of trunk (core) stabilization exercises early in~     treatment combined with lower extremity exercises will enhance the outcome over lower~     extremity exercises alone in the treatment of young athletes with anterior knee pain.~   "
71349|NCT02123589|"~     The study was designed to explore the effects of different sedation protocol on incidence~     rates of delirium and PTSD in severe patients with mechanically ventilation.~   "
71350|NCT02123576|"~     Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and~     octreotide therapy is superior to the standard of care alone in the treatment of Type I~     hepatorenal syndrome in the first 14 days of hospitalization.~   "
71351|NCT02123563|"~     Diabetes and obesity affect many people in different countries. Similarly, millions of~     people have some type of gum disease such as gingivitis. The present study was conducted to~     clarify if systemic conditions such as diabetes and obesity could impair the response to~     gingivitis treatment. Subjects with gum disease showing diabetes type II (from 40 to 50~     subjects), slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40~     to 50 subjects) were selected for the present study. In addition normal-weight subjects with~     gum disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50~     subjects) were selected for comparisons. After verbal and written explanations about the~     study, subjects who matched study criteria and who signed the informed consent form~     underwent full oral examinations in two separate visits. In the first visit, after a~     clinical examination to verify the levels of gingival inflammation and the accumulated~     amounts of dental plaque, the bone height was determined by X-Ray examinations. Bad breath~     was also evaluated by a chair-side apparatus. Additional laboratorial examinations included~     a) quantification of bacteria that cause gum disease from dental plaque samples, b)~     quantification of inflammatory products from gingival fluid sampling and c) quantification~     of produced saliva. Self-report questionnaires were used to check the impact of oral~     condition and treatment of gum disease in quality of life and individual daily performance.~     These examinations were repeated 3 months after dental treatment. All subjects received~     ultrasonic dental prophylaxis for cleaning their teeth. Based on systemic/oral conditions~     each group rinsed either an essential-oils containing mouth rinse or a placebo rinse. First~     rinse was supervised and the other ones were performed at home twice a day for three months.~     Each participant also received a toothbrush, a dental floss and a fluoride toothpaste~     monthly after oral hygiene instructions. Adherence to the treatment and occurrence of~     undesirable side effects were monitored throughout the study.~   "
71352|NCT02123550|"~     This prospective controlled study examines the use of Doppler ultrasound as a means to~     screen elective plastic surgery patients for the presence of deep venous blood clots both~     before and after surgery. This is a noninvasive technique that is known to be both sensitive~     and specific for the detection of deep venous thromboses in the lower extremities. This~     method may make it unnecessary to select patients for prophylactic anticoagulation, which~     poses additional risks to the patient.~   "
71353|NCT02123537|"~     People with multiple sclerosis (MS) often suffer from foot drop, which impairs their walking~     ability. Foot drop is the inability to lift the foot during the swing phase of walking. The~     purpose of this study is to find out if electrical stimulation of the leg, using the Bioness~     L300 Foot Drop System, can be used to treat foot drop in people with MS. It is expected that~     using this system will reduce foot drop, and therefore improve walking ability, particularly~     in the areas of speed, strength, balance and falls.~   "
71358|NCT02123329|"~     Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth~     Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar~     smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and~     deaths. Health care providers are in an ideal position to encourage smoking cessation.~     Pharmacists are the most accessible health care providers and are uniquely situated to~     initiate behavior change among patients. Many western studies have shown that pharmacists~     can be successful in helping patients quit smoking. Studies demonstrating the effectiveness~     of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims~     to test the effect of a structured smoking cessation program delivered by trained ambulatory~     pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8~     ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a~     4-session face-to-face structured patient-specific smoking cessation program conducted by~     the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by~     the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary~     outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months.~     If proven to be effective, this smoking cessation program will be considered as a model that~     Qatar and the region can apply to decrease smoking burden.~   "
71359|NCT02123316|"~     To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in~     the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in~     symptom scores and medication use in the active group compared to placebo.~      The influence of treatment in in vitro and in vivo objective parameters was also~     assessed.~   "
71360|NCT02123303|"~     Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several~     different underlying diseases, conditions, or combinations of medicines may contribute to~     OH; therefore the cause of the condition varies among individuals. Some studies have shown~     that OH is associated with an increase in the rate of death, but it is not clear what role~     OH plays in increased morbidity. By studying what the prevalence of OH is in a generalized~     veteran population we expect increase clinical awareness of the degree of the problem so~     that patient care might be improved.~   "
71361|NCT02123290|"~     This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of~     DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in~     adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60~     patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax~     and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance~     of parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14~     (success criteria for dose de-escalation and continuation of the study).~   "
71362|NCT02123277|"~     The study aim is to evaluate the tubal score on patients who suffer from obstructive~     dysfunction of eustachian tube before and after the eustachian tube dilatation.~   "
71363|NCT02123264|"~     The progression of structural joint damage is the leading cause of disability and~     socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical~     activity not always imply absence of progression of structural damage. The main objective of~     this study is to evaluate the progression of radiological damage in early RA patients~     currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease~     activity to which treatment with zoledronic acid is added.~      The investigators propose a randomized clinical trial in 94 patients with RA of less than 2~     years of evolution that, being treated with DMARDs, present criteria of low disease activity~     (DAS28 < 3.2).~      Patients will be randomized into two branches: zoledronic acid and no treatment. The primary~     study endpoint is the progression of radiological damage assessed in a blinded way by the~     difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after~     two years; the secondary variables: radiographic progression after one year, serum bone~     biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of~     patients, the investigators shall evaluate the change in the size of hand erosions by~     multislice computed tomography and the evolution of periarticular osteoporosis and systemic~     bone mass by dual X-ray absorptiometry (DXA).~   "
71364|NCT02123251|"~     The purpose of this randomized controlled trial study is to examine the extent that~     financial incentives when combined with diabetes evidence-based practices, improve~     self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c~     of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program.~      Specific Aims:~        1. Evaluate whether financial incentives for completing ADA recommended tests, exams and~          vaccinations will improve compliance rates.~        2. Evaluate whether financial incentives for health education and biometric outcomes will~          improve diabetes patients' self-management.~        3. Evaluate the extent to which financial incentives for healthy behaviors reduce health~          care utilization.~   "
71365|NCT02123238|"~     The study aims to evaluate the effect of non-supine positioning in the treatment of surgical~     patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will~     result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per~     hour of sleep.~   "
71366|NCT02123225|"~     The goal of this study is to determine if the investigators can use the STOP-BANG score to~     identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the~     early postoperative period after major surgery.~      Hypotheses:~        1. - Postoperative sleep apnea parameters will be worse when compared to baseline in~          patients with higher scores on the STOP-BANG.~        2. - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in~          patients undergoing Total Knee Arthroscopy (TKA).~   "
71377|NCT02123069|"~     The purpose of this study is to learn how uterine fibroids may be connected to heart disease~     and high blood pressure. It is not known what causes fibroids, but they frequently occur in~     women who also have high blood pressure, heart disease, and stroke. The investigators of~     this study want to learn if certain changes in the blood vessels or nerve activity can put~     women at risk for these diseases and for fibroids.~   "
71378|NCT02123056|"~     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and~     probably is responsible for CDN $250 million in health care spending each year. It is~     associated with decreased quality of life, trauma, loss of employment, and limitations in~     daily activities. The most common cause is vasovagal syncope.~      This occurs in people of all ages, and is a lifelong predilection. While the median number~     of faints in the population is 2, those who come to the investigators care have a median~     10-15 lifetime spells, and have an increased frequency in the year before presentation.~     Vasovagal syncope is due to abrupt hypotension and transient bradycardia, which cause~     cerebral hypoperfusion. The pathophysiology may be either failure of venous return or~     progressive vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic~     stimulation might be involved early in the reflex cascade. There is no known medical~     treatment for frequent fainting. The investigators performed the pivotal CIHR-funded~     randomized trials that showed that neither permanent pacing, beta blockers, nor~     fludrocortisone help the majority of patients.~      However 3 observational studies suggested that beta blockers prevent syncope in older~     subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, -stratified~     analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis~     showed a benefit from metoprolol in these patients, with a hazard ratio of 0.52 (CI 0.27 to~     1.01), and an age-specific response to beta blockers (p = 0.007). These results suggest the~     need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope~     in older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and~     neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92%~     agreed to participate in such a trial. Separately, this study emerged as the first choice~     for syncope randomized trials after consultation with Canadian and international experts.~      Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate~     to severely frequent vasovagal syncope will better suppress syncope recurrences than~     placebo.~      Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled,~     randomized clinical trial.~      Patients will be enrolled during a recruitment period of 4 years and followed for a fixed~     period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of~     vasovagal syncope based on a quantitative diagnostic score. They will be randomized to~     receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will~     be made according to treating physician discretion to optimize tolerance and compliance~     while maximizing dose. The primary outcome measure will be the time to the first recurrence~     of syncope (after a 2 week dose titration wash-in period) over the 1-year observation~     period. The primary analysis will be performed on an intention-to-treat basis. Secondary~     analyses will include an on-treatment analysis, as well as analyses comparing syncope and~     presyncope frequency, number needed to treat, quality of life, impact of syncope on daily~     living, and cost from the perspective of the publicly funded health care system. The~     investigators will enroll 248 patients to have an 85% power to detect a reduction (p<0.05)~     in the primary outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative~     risk reduction. This sample size also allows for a 11% rate of subject dropout with loss to~     follow-up before a syncopal event. The University of Calgary Syncope Clinic has a~     well-functioning clinical trial apparatus that successfully completed the randomized,~     multicenter Prevention of Syncope Trials (POST1: metoprolol for vasovagal syncope; POST2:~     fludrocortisone for vasovagal syncope) and SIRCAT (Statin-Induced Reduction of~     Cardiomyopathy Trial). Enrolment is underway in the CIHR-funded POST3 (pacing versus loop~     recorders in syncope patients with bifascicular block) and POST4 (midodrine for vasovagal~     syncope). Study centres that were highly productive in POST1-4 have agreed to participate.~     The investigators therefore will have ample syncope enrolling centres.~      Relevance: This study will provide evidence to inform the use of metoprolol in the treatment~     of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the~     lack of any other conventional medical therapy the investigators expect it to have rapid~     impact on care.~   "
71396|NCT02122822|"~     RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help~     the body build an effective immune response to kill tumor cells.~      PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of~     glioblastoma and to see how well it works in treating patients with newly diagnosed~     supratentoria glioma.~   "
71367|NCT02123212|"~     The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C)~     compares the effectiveness of the birth cohort HCV screening strategy with the current~     risk-based screening approach to detect previous unidentified persons with viral hepatitis C~     who receive health care in primary systems.~      The study involved three clinical sites, The University of Alabama, Birmingham; The Henry~     Ford Health System; and the Mount Sinai Medical Center, each of which developed an~     independent intervention to experimentally compare the number of positive Hepatitis C Virus~     (HCV) diagnoses found using the birth-cohort screening approach with that found using~     traditional risk-based screening, or standard of care strategies. Birth cohort testing is~     defined as the systematic recommendation of HCV antibody testing to any persons born during~     the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody~     test without regards to the patient's stated risk of exposure to the virus.~   "
71368|NCT02123199|"~     A prospective observational multi centre research study in GP practices clustered within up~     to 10 UK Primary care trusts.~   "
71369|NCT02123186|"~     To test if the routine newborn screening dried blood spots can be used to test if missing 2~     copies of SMN1 gene, a status indicating spinal muscular atrophy~   "
71370|NCT02123173|"~     Non-intubated thoracoscopic surgery has been proved as an adequate alternative for~     management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary~     metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the~     hemodynamic changes during one lung ventilation have not been fully investigated. The goals~     of this study are to compare the changes of hemodynamics (including blood pressure, heart~     rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung~     ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic~     (VATS) operations.~   "
71371|NCT02123160|"~     This study compares the effectiveness of Child Parent Psychotherapy to that of usual care~     (defined as: referral to therapists in the community or Columbia University Medical Center)~     in improving maternal depressive symptoms and child emotional and behavioral disturbances.~     The investigators will recruit mothers who report being mildly to moderately depressed and~     their preschoolers (ages 3-5 years) who they are concerned are exhibiting emotional and/or~     behavioral problems.~   "
71372|NCT02123147|"~     Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland~     dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and~     dry eyes symptoms. It can be systemic by affecting other organs including the~     gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement~     of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while~     approximately 20% of patients develop various neuropathies, including sensory, peripheral,~     cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia,~     lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune~     connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more~     frequently than men, suggesting a role for sex hormones in disease susceptibility or~     progression. One common feature of SjS is it infiltration of mononuclear cells into the~     salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci~     (LF). Critical to the studies proposed is the fact that a predominant cell population of LF~     is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive~     to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in~     receptor gene repertoires of autoreactive B and T cells at different time points during the~     disease process and examine the correlation with various disease parameters.~   "
71373|NCT02123134|"~     The objectives of this study are to explore the safety and efficacy of subcutaneous~     injections of ATX-101 relative to placebo, in the submental area of subjects who are 65 to~     75 years old.~   "
71374|NCT02123121|"~     Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function~     of mitochondria (energy producing components) within the leg muscles of moderate functioning~     older adults.~      The investigators will look at the role Resveratrol plays in improving physical function by~     studying the connection of changes in mitochondrial function and changes in physical~     function.~   "
71375|NCT02123108|"~     This is an investigator initiated study at the University of California, Los Angeles (UCLA)~     funded by Novartis looking at using a combination of immunosuppressive drugs in liver~     transplant patients that are at risk of developing kidney problems. Kidney problems~     following liver transplants is the most problematic issue facing liver transplant patients~     today.~      This study will generate information in this area of high unmet medical need utilizing~     basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard~     of care medications, after kidney function has normalized.~      This study will enroll 60 subjects. 30 subjects in each of the two groups. Subjects will be~     followed for 1 year after liver transplant.~   "
71376|NCT02123082|"~     Urolithiasis (kidney stones) is a common disease process affecting people all across the~     world. Usually, if the stone size is small, it is able to pass through the urinary system~     and exit the bladder on its own with no treatment. However, when the size of the stone is~     bigger, it can get trapped in the kidney or the ureter, causing significant pain for the~     patient and potentially obstructing urine flow. If this occurs, surgical treatment is~     necessary for the removal of the stone. The surgical procedure often employed involves the~     use of a ureteroscope, which is a device that includes a camera and channels for working~     instruments such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes~     that are currently in use are flexible and have the ability to treat stones that may~     otherwise be inaccessible in the kidney. Most flexible ureteroscopes in clinical use~     currently only have one channel therefore only allowing one instrument to be used at a time.~     Recently, a new type of ureteroscope has been introduced in the market that offers the~     advantage of having two working channels where two instruments can be inserted for use~     during stone treating procedure. This can potentially decrease procedure time for patients~     affected by kidney stones.~      The purpose of this research is to compare the efficacy and safety of the ureteroscopes that~     have only one channel for instrument insertion with the newer ureteroscope that has two~     channels for utilization during stone treatment.~   "
71389|NCT02122913|"~     This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in~     adult subjects with advanced solid tumors that have progressed or are non responsive to~     available therapies and for which no standard or available curative therapy exists.~   "
71379|NCT02123043|"~     Many older adults lack the skill of efficient wheelchair propulsion despite being the~     largest cohort of wheelchair users. Inefficient wheelchair propulsion can lead to fatigue~     and overuse injuries that can result in lost independent mobility. This study will evaluate~     the effectiveness of a new training strategy using a motor learning based approach to train~     efficient wheelchair propulsion. Participants will be randomly assigned to one of three~     groups: 1) No practice; 2) Motor learning-based training; or 3) Practice (time-matched to~     training). Potential improvements based on training will be explored for wheeling~     biomechanical variables and energy efficiency.~      Study Hypothesis: We expect that the Training intervention will be superior to the Practice~     intervention for improving the biomechanical and physiological efficiency of wheelchair~     propulsion. It is also hypothesized that both the Training and Practice interventions will~     be superior to no practice.~   "
71380|NCT02123030|"~     Use of a microfabricated silicon device to concentrate ultra trace volatile organic~     compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.~   "
71381|NCT02123017|"~     The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with~     escalating doses of lactulose to be used as a preparation for colonoscopy.~   "
71382|NCT02123004|"~     1. Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a~          greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI)~          patients receiving percutaneous coronary intervention.~        2. Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and~          in peripheral venous in patients with ST-segment elevation myocardial~          infarction(STEMI).~   "
71383|NCT02122991|"~     Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians~     with the challenge of managing the secondary complications of SCI with the chronic diseases~     common in an aging population. Cardiovascular disease, cerebral vascular disease, and~     cognitive dysfunction are among the primary challenges facing clinicians in the treatment of~     an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI~     population, which have been primarily attributed to concomitant traumatic brain injury or~     pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the~     increased prevalence of cognitive dysfunction in the SCI population is of significant~     clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible~     contributors to the cognitive disorders in the general population. These risk factors~     include: physical inactivity, chronically low or high blood pressure (BP), reduced blood~     flow to the brain, arterial stiffening, and impaired nervous system regulation of the~     cardiovascular system. These risk factors are particularly prominent in the SCI population~     as they represent a model of profound inactivity, have trouble regulating blood pressure,~     and suffer impaired cardiovascular regulation from their injury. In addition, we've recently~     reported deficits in blood flow to the brain at rest and during cognitive tests; with~     results being further impaired in SCI with chronically low blood pressure. Therefore the~     goals of this project are to determine the influence of cardiovascular and cerebral vascular~     responses at rest and during cognitive testing on test performance in 80 individuals with~     SCI compared to 50 age-matched non-SCI controls. All potential subjects will undergo a~     rigorous two-part screening process which consists of an initial screening via telephone and~     a detailed, in-person screening. Eligible subjects will be invited to participate in a 3~     hour laboratory visit during which their arterial stiffness, blood pressure, heart rate,~     respiration rate and, blood flow to the brain will be monitored at rest and during a~     comprehensive series of cognitive tests.~      We hypothesize that blood pressure and cerebrovascular response to testing will account~     significantly for performance in cognitive testing that otherwise would have been~     attributable to SCI status.~   "
71384|NCT02122978|"~     Increasing research evidence supports the effectiveness of mindfulness based interventions;~     however, the exact mechanisms of change are poorly understood. Some evidence proposes that~     self-compassion is an important mechanism of change in the effectiveness of mindfulness~     based interventions. The current research will evaluate and compare the effectiveness of two~     mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and~     Mindfulness based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin~     condition commonly associated with stress. Blood analyses will be conducted to assess and~     compare the impact of the interventions on the immune system. Self-report questionnaires~     will explore participants' psychological functioning (e.g. self-compassion, depression,~     anxiety, worry). This study will also examine whether a relationship exists between immune~     functioning and psychological factors. An audio-guided MBSCT programme will be piloted, with~     a view to trialling as a more cost-effective alternative to traditional mindfulness~     interventions. Findings will enable us to design more effective interventions in the future,~     and yield clear results regarding the existence of a definite link between immunological~     functioning and psychological functioning.~      The main research hypothesis is that participants who complete a mindfulness based~     intervention will experience significantly greater psychological well-being, symptom~     reduction, and greater changes in telomerase and cytokine activity than individuals who only~     receive treatment as usual for their psoriasis.~   "
71385|NCT02122965|"~     Adverse drug events are unintended and harmful events related to medication use and a~     leading cause of emergency department visits, unplanned hospital admissions and deaths. In~     the emergency department, physicians frequently misdiagnose adverse drug events leading to~     treatment delays. Our objective is to evaluate the effect of pharmacist-led medication~     review in high-risk emergency department patients on prolonged hospital stay.~      This prospective multi-centre, quasi-randomized study is nested within an existing quality~     improvement program. Triage nurses flag incoming emergency department patients at high-risk~     for adverse drug events by applying a clinical decision rule consisting of four variables~     (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and~     age). Consecutive eligible high-risk patients are enrolled into the medication review study,~     and systematically allocated to pharmacist-led medication review or usual care. In the~     intervention group, medication review pharmacists collect best-possible medication~     histories, review the patient's medications for appropriateness and adverse drug events, and~     communicate the results of medication review to patients, caregivers and physicians. In the~     usual care group, physicians refer patients to onsite pharmacists for medication management~     questions on an as needed basis. Health outcomes are assessed using anonymized data linkage~     to administrative health databases. The primary outcome is the percent of days spent in~     hospital during the first 30 days after the index emergency department visit~   "
71386|NCT02122952|"~     The purpose of this trial is to evaluate safety and efficacy of intravenous delivery of~     AVXS-101 as a treatment of Spinal Muscular Atrophy type 1 (SMN1).~   "
71387|NCT02122939|"~     An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the~     effect on ECG of escitalopram after oral administration in elderly volunteers.~   "
71388|NCT02122926|"~     The goal of this study is to design and implement an intensive discharge intervention for~     inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the~     intervention on post-discharge insulin adherence, glycemic control, cardiac medication~     adherence, hypoglycemic events, and emergency department visits and hospital readmissions.~   "
71399|NCT02122783|"~     The purpose of this study is to evaluate how two different settings of a commercially~     available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot~     orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in~     addition to the conventional hard stops, to limit the range of motion of the ankle during~     walking. The results of this study will help to clarify 1) whether and how this new joint~     affects the way you walk, 2) whether it makes it easier for the clinician to align your~     brace and 3) your opinions about the new joint.~   "
71400|NCT02122770|"~     The primary purpose of this study is to assess the effect of multiple-dose administration of~     fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and the~     effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.~   "
71401|NCT02122757|"~     Anodal tDCS increases the excitability of the cerebral cortex and its daily application~     during intercritical phase, may have a therapeutic effect in episodic migraine.~   "
71402|NCT02122744|"~     Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic~     migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease~     the frequency of migraine and if its effect is stronger than placebo effect.~   "
71403|NCT02122731|"~     To evaluate the antihypertensive effect of amiloride added to triple antihypertensive~     therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)~   "
71404|NCT02122718|"~     Recurrent stroke and cognitive decline are common after ischaemic stroke. Allopurinol, a~     drug usually used to treat gout, has been shown to reduce heart ischaemia, heart size, and~     arterial stiffness and to relax brain blood vessels and may reduce the blood pressure. All~     of these properties may be associated with a lower risk of second stroke and cognitive~     decline. We now aim to explore whether allopurinol will reduce further damage to the brain~     (called white matter hyper-intensities) after stroke and also whether it reduces heart size~     and blood pressure after stroke.~      We will conduct a multi-centre randomised, double-blind placebo controlled study to~     investigate whether two years allopurinol 300 mg twice per day (BD) improves these 3~     outcomes, which are inextricably linked to risk of recurrence and cognitive decline after~     ischaemic stroke.~   "
71405|NCT02122705|"~     This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm~     which would benefit labouring mothers who are unable or unwilling to receive epidural~     analgesia.~   "
71406|NCT02122692|"~     To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the~     multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive~     metabolisers).~   "
71407|NCT02122679|"~     Tranexamic acid is a relatively safe medicine that is used to help the body develop clots~     and slow down bleeding after large surgeries. While it has already been shown to work well~     in adults and older children, there is no information on whether it works, and how it works~     in children younger than 6 months old. The goal of our study is to try and understand~     whether and how tranexamic acid works in children younger than 6 months old who are having~     open heart surgery.~      We plan to study tranexamic acid by testing its effect when compared with a placebo. The~     investigators will use a method called randomization - which means patients who agree to be~     in the study will be entered into a computer. The computer will randomly assign them to~     either receive the medicine or the placebo. We will then compare effects on the 2 groups of~     patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not~     know whether patients receive tranexamic acid or placebo until we review the data collected~     at the end of the study.~      Tranexamic acid is usually given to patients in the operating room during open heart~     surgery. During open heart surgery patients require cardio-pulmonary bypass which is a~     machine that replaces the function of the heart and lungs for a short period of time. This~     allows surgeons to do surgery on the heart itself without having to worry about it moving~     during the operation. The bypass machine has lots of tubes to carry the blood around it.~     When blood comes into contact with the tubing it has a tendency to clot. To prevent this~     patients are given a blood thinner called heparin. Although heparin prevents clotting in the~     bypass machine, it can also increase the risk of bleeding when the surgery is over. To~     reduce this risk patients are given another medicine at the completion of surgery called~     protamine to try and reverse the effect of the blood thinner, heparin.~      Even so bleeding remains a significant problem, especially for babies after open heart~     surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase~     that risk. In addition, the bypass machine affects the function of platelets, the main~     component of the body's clotting system. We often have to replenish blood products after~     surgery to try and stop the bleeding. Some centers, including we , have used the medicine~     tranexamic acid to try and help with bleeding after surgery. There have been other studies~     that show it helps with fibrinolysis, which is another important part of the body's clotting~     system. However, that part of the clotting system is not well developed in infants and~     therefore likely does not play an important role in preventing bleeding in that age group.~      As such, it may be that tranexamic acid impacts platelet function as well, and it is that~     effect that helps decrease post-operative bleeding in infants younger than 6 months. This~     has not been previously studied. In order to study the effect that tranexamic acid has on~     platelets the investigators are proposing the investigators' research trial. The~     investigators plan to randomize patients to either receive tranexamic acid or placebo in the~     operating room as described above. The investigators will then draw a small amount of blood~     from each patient (total of approximately 1 tablespoon) and send it to a special lab for~     testing of platelet function. The lab test will help us understand whether the platelets~     function better when patients receive tranexamic acid instead of placebo.~      The investigators will also be monitoring other outcomes related to platelet function. These~     will include how much bleeding patients have after surgery when they are in the intensive~     care unit, and how much blood products they require to treat that bleeding. The~     investigators will also monitor labs that are checked routinely in all patients after open~     heart surgery. The investigators will also track how long it takes each patient to get off~     the ventilator and how long they spend in the ICU after surgery. All of this data will help~     us understand whether tranexamic acid makes a positive impact on outcomes after open heart~     surgery in infants less than 6 months old.~      The current standard of care is quite variable within our institution as well as at other~     institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is~     no definitive guideline to its current use. The dosing differs from center to center, and~     there are some centers that do not use it at all.~      The investigators' hope is that the results of this study will help us understand the role~     tranexamic acid plays in preserving the function of platelets after open heart surgery in~     young infants, and whether that impact translates into improved outcomes for those patients.~     Based on the results of our research we hope to develop definitive guidelines for the use of~     tranexamic acid in the population of infants <6 months old undergoing open heart surgery.~   "
71408|NCT02122666|"~     The investigators previous research has suggested that lipid (fatty) composition in the~     muscle cells of mice plays a key role in their insulin sensitivity. The purpose of this~     study is to determine whether these specific fat signatures translate to humans by comparing~     the muscle of healthy patients to those with pre-diabetes, or the metabolic syndrome.~   "
71409|NCT02122653|"~     Muscle strength and endurance are important indexes of fitness. The muscle strength is the~     most important single predict factor of functional ability in aged frail individuals.~     Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Finding~     the contributions of the central and the peripheral factors to the deficits of muscle~     fitness and developing an effective muscle fitness training program for pre-frail~     individuals are very important.~      The muscle weakness and fatigue can be categorized into peripheral or central causes. The~     central fatigue and voluntary activation failure originate from the decrease in motivation~     or the reduction of the conduction within corticospinal tracts. Long term activation failure~     and central fatigue will cause disuse of muscle and result in peripheral weakness and~     peripheral fatigue. Studies found the selective type II fiber atrophy in aged people and~     this finding was different from the type I atrophy in conventional immobilization models. It~     is possible that the activation failure leads to the recruitment failure of high threshold~     type II fibers at the pre-frail stage. Quantifying the weighting of central versus~     peripheral factors contributing to the exercise limitation in pre-frail people is important.~      Most of the conventional strength and endurance training programs are based on the~     researches of young groups. These programs are not able to prevent people become frail. It~     is possibly that, due to the limitation of central fatigue, the pre-frail individuals stop~     exercise before the effective intensity being achieved. Almost no training program has been~     design for enhancing the voluntary activation level and relief the central fatigue. Seeking~     an appropriate training program to enhance central activation at the pre-frail stage is very~     important for preventing people become frail.~      Previous studies have shown that increasing afferent input by peripheral electrical~     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary~     sensory cortex, the excitability of corticospinal tracts, and the functional performance in~     young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method~     to be used in training. Combining afferent input with strength training might be able to~     overcome the central activation failure and help recruit high threshold motor unit in~     pre-frail individuals.~   "
71410|NCT02122640|"~     LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT~      Introduction~      This is a prospective randomized trial realized in the Emergency Department of the~     University Hospital of Siena, Italy.~      Dyspnea is one of the most common causes worldwide of admission to the Emergency Department~     (ED) and acute heart failure (AHF) is a major cause of serious morbidity and death in such~     population, above all in elderly patients. Incidence rate is signiﬁcantly higher in men than~     in women, in Europe it increases with age from 1.4/1000 person-years in subjects aged 55-59~     years to 47.4/1000 person-years in those aged 90 years or older. The age-adjusted prevalence~     of AHF in the United States averages 36 cases per 100,000 of the population and accounts for~     10,000 deaths annually.~      In clinical practice this symptomatology is usually investigated in the pre-hospital phase~     only with history and physical examination; in the ED blood gas analysis (BGA), laboratory~     tests and chest X-rays can be performed as primary exams. BNP and NT pro-BNP are now~     considered reliable biochemical markers to distinguish cardiogenic from pulmonary etiology,~     both for their diagnostic and prognostic value. On the other hand, these biomarkers are~     affected by a grey zone of uncertainty, they are not available in all hospitals and their~     dosage samples are expensive: thus we propose other tools to support the diagnostic process.~   "
71411|NCT02122627|"~     Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect~     of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D~     deficiency.~   "
71467|NCT02121899|"~     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on~     influencing treatment decisions of Oncologists when added to standard clinical-pathological~     parameters in patients with early stage NSCLC.~      The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003)~     and the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).~   "
71468|NCT02121886|"~     To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB~     surgery. Although the parietal peritoneum had already been used and published for the~     reconstruction of the vena cava, however this one was never described or described in HPB~     surgery~   "
71412|NCT02122614|"~     The aim of this randomized controlled trial is to investigate the effects of adding PA~     monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary~     rehabilitation (PR) program on daily PA levels and health status of patients with COPD.~      Patients will be randomized to either receive a PR program with PA monitoring and regular~     feedback of a pedometer (experimental group [EG]) or a PR program alone (control group~     [CG]). During the PR program, patients in the EG will receive a pedometer to self-monitor~     their PA and individualized step-count goals. They will continue to use the pedometers and~     receive individualized goals for 3 months after the program.~      It is expected that, by receiving individualized goals and a simple pedometer to~     self-monitor their PA during and after a PR program, patients with COPD will become more~     active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.~   "
71413|NCT02122601|"~     To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel)~     when it is administered for the second time 26 weeks after its first administration in~     patients with osteoarthritis of the knee.~      The Safety and efficacy of 26weeks after its first administration will be also evaluated.~   "
71414|NCT02122588|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative hospitals in order to assess 1st line treatment management and diagnostic~     approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and~     assess patients` characteristics and the occurrence of BRCA (Breast Cancer gene) mutations~     among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube~     cancer. No additional procedures besides those already used in the routine clinical practice~     will be applied to the patients. Treatment assignment will be done according to the current~     practice.~   "
71415|NCT02122575|"~     Background:~      - Restricting calories can help a person reduce risk factors for heart disease. Researchers~     have found that not eating or drinking anything but water for 24 hours prevents the~     activation of a component of the immune system, called the inflammasome. The inflammasome is~     associated with the development of diabetes and heart disease. Researchers want to learn~     more about the body s response to fasting.~      Objective:~      - To explore the benefits of calorie restriction on heart health.~      Eligibility:~      - Healthy adults ages 21 32 with a body mass index between 26 and 29.~      Design:~        -  Participants will be screened with a medical history, physical exam and blood test.~        -  Participants will not eat or drink after 10 p.m. before their first visit.~        -  Participants have breakfast at the clinic. The breakfast will be about 500 calories.~          Then they will not eat or drink (except water) for 24 hours.~        -  Participants will return to the clinic the next morning. They will have blood drawn.~          Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after~          the meal.~        -  Blood and urine tests at the end of the fast and following the meals will be done to~          confirm that participants have fasted for the full 24-hour period.~   "
71416|NCT02122562|"~     Objective:~      Glutamate-based medications including the N-methyl-D-aspartate (NMDA) receptor antagonist~     ketamine result in rapid, robust and sustained (up to one week) antidepressant effects in~     randomized controlled trials in treatment-refractory unipolar and bipolar depression.~     Previous work by our group has demonstrated that a family history of alcohol dependence~     predicts a more robust antidepressant response to ketamine in both treatment-resistant~     unipolar and bipolar depression.~      Recently-detoxified alcoholics and affected first-degree relatives display blunted~     psychotomimetic, cognitive and other neuropsychiatric effects with a subanesthetic dose of~     ketamine. Also, a family history of alcoholism alone predicts differential response to~     intravenous alcohol. Based on our prior post hoc results, we seek to prospectively~     demonstrate that a family history of alcohol dependence predicts a more robust~     antidepressant response to ketamine. We will also explore potential biomarkers of ketamine s~     antidepressant effects in treatment-refractory depressed patients at risk of alcohol~     dependence (using physiological and neurochemical responses to alcohol).~      Study Population:~      21-65 year old treatment-resistant major depressive disorder without psychotic features~     patients in a current major depressive episode of at least moderate severity will be~     recruited and enrolled in this protocol. All subjects must also be free of a lifetime~     substance use disorder diagnosis with the exception of a nicotine or caffeine use disorder)~     and will be psychotropic medication-free for at least two weeks prior to the first alcohol~     infusion. Our targeted number of completers will be 50 depressed subjects (60 signing~     consent to account for attrition): 25 FHP subjects [as defined by either one first degree~     relative or two second-degree relatives with alcohol dependence on the Family Interview for~     Genetics Studies (FIGS) and Family Tree Questionnaire (FTQ)] and 25 FHN negative subjects.~      Design:~      This study is a single-site, open-label protocol in psychotropic medication-free depressed~     subjects admitted to the Clinical Research Center s Mood and Anxiety Disorder Inpatient~     Research Unit (7-SE). This protocol consists of two phases (Phase I and Phase II). The first~     phase consists of the medication taper and drug-free period. The second phase will have~     three subphases: Subphase IIA ( alcohol clamp infusion #1 with neurophysiological~     assessments), IIB ( alcohol clamp infusion #2 during 7 Tesla-Magnetic Resonance~     Spectroscopy/Imaging (7T-MRS/I)) and IIC (subanesthetic/antidepressant dose ketamine~     infusion during 7T-MRS/I).~      Outcome Measures:~      The primary hypothesis/outcome measure will be change in mean Montgomery-Asberg Depression~     Rating Scale (MADRS) total score from the pre-ketamine infusion baseline-to-7 days~     post-infusion between the FHP and FHN groups. Other exploratory measures include~     neurophysiological responses to intravenous alcohol infusion, brain neurochemical~     alterations during intravenous alcohol infusion, brain neurochemical alterations during~     intravenous ketamine infusion and resting state (task-free) functional magnetic resonance~     imaging as a function of family history of an alcohol use disorder.~   "
71417|NCT02122549|"~     This study will obtain device-human interaction evaluations for the HWD1000 within the~     controlled environment of the hospital as well as establish that the safety profile is~     similar to outpatient wearable cardioverter-defibrillators use.~   "
71418|NCT02122536|"~     The aim of this prospective, randomized, double-blind, intraindividual split face study will~     be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial~     wrinkles using a 1:1 dose ratio.~   "
71419|NCT02122523|"~     The sentinel lymph node (SLN) procedure is a standard staging technique in several types of~     cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an~     optimal dye and technique for identification of the nodes. In this study the investigators~     used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly~     developed NIR laparoscope. The investigators compared two different injection techniques;~     subserosal and submucosal injection.~      Patients planned for a laparoscopic resection of a colorectal carcinoma without distant~     metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten~     minutes after injection the investigators searched for fluorescent nodes with the NIR~     laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and~     additional immunohistochemistry.~   "
71420|NCT02122510|"~     In this study, the investigators will compare the analgesic effect of bupivacaine and~     bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP~     block, on the patients for whom the operation will be performed under general anesthesia.~   "
71421|NCT02122497|"~     The aim of the present study is the evaluation of cardiovascular biomarkers in patients with~     abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open~     (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome.~      By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain~     Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T~     (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification~     by assessment of cardiac stress tolerance. Data gathered may help to simplify the decision~     whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be~     performed.~      Study Hypothesis:~      The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP,~     hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.~   "
71422|NCT02122484|"~     There is evidence that inflammatory processes may play a key role during surgical myocardial~     reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent,~     may lead to reduction in periprocedural infarct size, when administered during elective~     coronary artery bypass graft surgery.~   "
71423|NCT02122471|"~     The purpose of this study is to confirm that the investigational medication, plecanatide, is~     safe and effective in treating chronic idiopathic constipation.~   "
71424|NCT02122458|"~     The purpose of this study is to study blast-exposed Veterans who report hearing handicap but~     show normal or near normal results on standard audiometric testing. The characteristics and~     nature of their auditory and auditory-related skills will be examined, along with whether~     coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary~     treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids~     to determine if they benefit from low-level amplification of high-frequency sounds.~   "
71425|NCT02122445|"~     Low back pain is a problem which affects up to 70-80% of people in their lifetime. In the~     United States, it is estimated that the total direct and indirect costs of low back pain~     combined ranges from $19.6 to $118.8 billion. Recent studies have shown the importance of~     the gluteal musculature in the treatment of low back pain. It was found that the gluteus~     maximus (Gmax) is significantly more active in a low back pain population compared to a~     healthy population, indicating the low back pain population relied on the Gmax to fire more~     to overcome the gluteal weakness. A new approach to treating musculoskeletal conditions is a~     taping technique designed to target muscles and lymphatic system. Limited research is~     available for the treatment of specific conditions, including low back pain, but it is~     theorized to inhibit or facilitate the muscle, improve blood flow, reduce pain, and improve~     joint alignment. Methods: The purpose of this study is to determine the immediate and~     delayed effectiveness of Cramer® Sports Motion Tape on Gmax and lumbar paraspinal activation~     in a chronic mechanical low back pain population. A convenience sample of 20 new patients~     with current, chronic low back pain, no current neurologic signs or symptoms, no previous~     spinal surgery, no corticosteroid treatment within the last two weeks, and who are not~     pregnant will be recruited for this study. Patients will sign an informed consent, complete~     all initial paperwork. Surface electromyography will be used to quantify the activity level~     of the Gmax and lumbar paraspinals (LP). The MVIC will be estimated for each muscle group~     and the patient will perform a series of 4 randomized exercises, 5 repetitions each; Clams~     with Resistance, Standing Hip Abduction with Resistance, Sidelying Hip Abduction, and a~     forward bend. After each exercise the patient will rate How hard they are working on the~     RISE scale. Following the initial test, Cramer® Sports Motion Tape will be applied to the~     gluteal and low back area. After the tape is applied, the EMG exercise protocol will be~     repeated. The tape will be left on until the patient returns for their next appointment,~     within 24 to 48 hours, where they will have a delayed post-test. Patients will rate their~     pain, surface electrodes will be applied to the previous testing sites, and MVIC will be~     retested for each muscle group. The patient will perform the same protocol that was~     performed in the initial testing session. The EMG signals will be smoothed, rectified and~     analyzed using a root-mean-square algorithm. The investigators will use visual onset and~     offset of the EMG signal amplitude to select the middle 3 trials. Average activation and~     peak activation will be determined and compared to the MVIC for each muscle group, and~     expressed as a %MVIC. This will allow %MVIC to be compared and rank order among groups and~     muscles.~   "
71426|NCT02122432|"~     In France, there is usually a long delay (approximately 6 weeks) before a general~     practitioner can obtain a specialized advice by dermatologists for diagnosis of unusual~     dermatologic conditions of their patients.~      Previous studies have shown that teledermatology is a reliable way for diagnosis in~     dermatology.~      We hypothesize that a teledermatology advice could reduce delay before diagnosis and~     therefore treatment for patients.~   "
71427|NCT02122419|"~     We aimed to investigate the association between the position in which spinal anesthesia was~     performed and postdural puncture headache occurrence.~   "
71428|NCT02122406|"~     The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive~     disorders, and their relationship with disease activity, in patients with rheumatoid~     arthritis treated with biological drugs~   "
71429|NCT02122393|"~     Th purpose of this study is to determine whether dual psychological and pharmacological~     treatment is superior to either mono-therapy alone in the treatment of postnatal depression.~   "
71430|NCT02122380|"~     Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit~     diminished growth hormone (GH) secretion; the latter further contributes to the development~     of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing~     hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of~     dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic~     therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of~     GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will~     enhance GH secretion and vascular function while improving glucose tolerance in patients~     with impaired GH secretion who are at risk for the development of diabetes mellitus and~     cardiovascular disease, specifically obese women with polycystic ovary syndrome.~   "
71431|NCT02122367|"~     Appropriate indices to guide fluid therapy are essential for effective hemodynamic~     management during the perioperative period. Values derived from respiratory changes in~     arterial pressure waveform or plethysmographic waveform such as stroke volume variation and~     pleth variability index have been demonstrated to be able to predict fluid responsiveness in~     surgical or critically ill patients. Their ability to predict fluid responsiveness can be~     affected by factors that influence the arterial tone or the compliance of the respiratory~     system by position change. The aim of this prospective trial is to investigate the ability~     of stroke volume variation and pleth variability index to predict fluid responsiveness in~     the reverse trendelenberg position.~   "
71432|NCT02122354|"~     The objective of this research is the accumulation of gameplay data and simulator sickness~     background surveys for trend analysis, and individual simulator sickness trigger factor~     analysis for the test subjects involved. Rather than isolating specific variables for~     hypothesis formulation, this study will be attempting to collect an array of data that is a)~     both qualitative and quantitative, and b) observational and test subject-reported. The final~     results will consist of a list of possible trigger factors to avoid for individual subjects,~     and metrics showing the directional tendencies of players depending on the severity of their~     symptoms at the time.~      The overall goal of this research is to better understand factors that contribute to~     simulator sickness, both in who it affects and why some gameplay experiences may cause it~     more than others. Operating from the basic assumption that the way a player moves through an~     environment affects how quickly that player gets sick, we will primarily be gathering data~     on how the player moves through the digital space and whether that behavior changes once~     they begin to feel sick.~   "
71433|NCT02122341|"~     The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is~     intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.~   "
71434|NCT02122328|"~     The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using~     sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant~     method, selective laser photocoagulation of communicating vessels (SLPCV), may provide~     vascular stability to the donor fetus. The primary objective is to evaluate the perinatal~     outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a~     prospective, randomized trial.~   "
71435|NCT02122315|"~     Fractures of the proximal humerus account for between 5% and 8% off all reported fractures.~     Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft~     tissues surrounding the shoulder area can be damaged. The purpose of the current clinical~     trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain~     and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure~     for proximal humeral fixation or rotator cuff tear repair.~   "
71499|NCT02121483|"~     The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the~     safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18~     years with type 2 diabetes mellitus.~   "
71436|NCT02122302|"~     This investigation develops an online, patient self-assessment system, called CarePrep to~     support the care and clinical research of patients with chronic pancreatic disease and~     chronic pancreatic pain. This web-based assessment presents patients with questions that~     address medical, psychological, social, behavioral, and quality-of-life issues that are~     relevant to pancreatic disease. Patients will be given the opportunity to enter and track~     their symptoms over the Internet from home or clinic. The system is also designed to gather~     clues to identify neuropathic pain, which occurs when the nervous system fails to properly~     regulate pain signals. Any of these factors can contribute to chronic pain and may point the~     way to more effective treatment. The broad objective of this study is to extend CarePrep to~     cover a full range of topics that are relevant to chronic pancreatic disease. The study team~     will refine this content based on the system's accuracy in real clinical settings and direct~     efforts to maximize its feasibility.~   "
71437|NCT02122289|"~     Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.~     Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship~     between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments~     present health costs burden leading to important physical psychological and social impact.~     Preventing exacerbation and early detection of these exacerbations may decrease intensity~     and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased~     health cost.~      Patients actually follow in CRCM track exacerbations when visits out patient clinic and~     during phone call. If patients did not call or did not present regularly to out patient~     clinic, exacerbation detection came later and so increasde the burden and therapeutic~     pressure.~      The objective of our study is to identify earlier the potential exacerbations and so~     decreased the health costs and increased the patient's QoL. Forthis purpose we propose to~     use modern technologiessuch as smartphone in order to create alert when patients report~     weekly health satatus. We will compra patients randomize in control group with standart~     follow-up to patients randomize in the smartphone group.Moreover we will study the~     compliance and satisfactory degree of the use of this device in the interventional arm.~   "
71438|NCT02122276|"~     In animal and human studies, histochemical and physiological evidences showed that the~     muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after~     spinal cord injury. The alternation of muscular property was accompanied by the alternation~     of spinal circuitry property, and was related to the immobilization adaptation. Previous~     study showed that remobilization by continuous passive motion (CPM) for one month would~     restore the function of spinal circuitry in individual with chronic SCI. It is possible that~     long term application of CPM can reverse the adaptation of contractile properties of the~     paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four~     month CPM training on muscular properties in individuals with chronic SCI.~   "
71439|NCT02122263|"~     To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis~     and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.~   "
71440|NCT02122250|"~     This project will address vital questions regarding how best to design web-based materials~     for the growing population of patients with basic literacy and computer skills but lower~     levels of health literacy, building on our previous experience of developing web-based~     materials for people with lower levels of literacy and health literacy.~      This study will be carried out two phases. Phase 1 will use qualitative methods to~     understand user experiences of the web-based materials through observational 'think-aloud'~     interviews with users. Phase 2 will test the newly developed web-based materials to a static~     (non-interactive) version of the materials online.~   "
71441|NCT02122237|"~     Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application~     during intercritical phase, may have a therapeutic effect in chronic migraine.~   "
71442|NCT02122224|"~     One important factor determining school performance is the consumption of breakfast. While~     research has shown that older children perform better in school after consuming breakfast,~     there are little data for preschool-age children. Consuming breakfasts with different macro-~     and micronutrient contents may have different effects on performance, which may be~     associated with variations in satiation and satiety during and after the different~     breakfasts. In addition, children who consume breakfast have better diet quality than~     children who skip breakfast.~      The investigators will conduct a community based, randomized, crossover trial in 4-5 year~     old children over 7 weeks to examine the short-term effect of feeding preschoolers three~     different intervention breakfast types: high protein, high-fiber, or high protein and high~     fiber compared to a usual breakfast served at the preschool. The investigators expect that~     the children consuming any of the three experimental breakfasts will consume less overall~     calories and have better diet quality and memory performance compared to children who have~     the usual breakfast. The investigators hypothesis is that preschoolers will experience the~     highest level of satiety as well as highest level of overall diet quality when they consume~     the combined high-protein and high-fiber based breakfast foods.~      This study will be conducted at Bauer Family Resources in Lafayette as these are the sites~     of Head Start programs, which are preschools for children from low-income families. Children~     from families of low income are more likely to have poor diet quality and poor school~     performance compared to children from families with higher incomes. Therefore, this~     population is most in need of this type of intervention.~   "
71443|NCT02122211|"~     The ability of sperm to swim is important for normal fertility. Men with a genetic variation~     in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by~     sperm, and their sperm do not swim normally. The metabolic product of this gene is a~     nutrient called betaine (found normally in the diet as a part of many foods such as spinach,~     beets and grain products). This study tests whether treatment with betaine is safe and~     whether it can normalize energy production in sperm of these men and restore normal swimming~     ability.~   "
71744|NCT02118285|"~     This is a single center phase I trial designed to determine the maximum tolerated dose (MTD)~     of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of~     intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a~     non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the~     treatment of recurrent ovarian, fallopian tube, and primary peritoneal cancer.~   "
71444|NCT02122198|"~     Complaints about memory and thinking are common in women as they go through menopause and~     estrogen levels fall. The ovarian hormone estrogen is important for supporting normal~     cognitive function, and changes in brain activity and function occur when estrogen levels~     are decreased. Estrogen is also important for maintaining healthy blood vessels which also~     support normal cognitive function. In Alzheimer's disease and other types of dementia, there~     is significant damage to the blood vessels in the brain. This study will test whether~     changes in brain activity and function with the loss of estrogen are related to changes in~     vascular function. We will measure vascular function using ultrasound, and brain activity~     using MRI scans in women who are enrolled in the Females, Aging, Metabolism and Exercise~     (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either take a~     medication to decrease their estrogen levels, or a placebo. This sub-study may provide new~     information about how estrogen affects vascular function and cognitive function, and lead to~     new ways to prevent or delay cognitive impairment or dementia.~   "
71445|NCT02122185|"~     This randomized phase II trial studies how well metformin hydrochloride and combination~     chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or~     primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Metformin~     hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor~     cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory~     from patients receiving metformin hydrochloride may help doctors learn more about the~     effects of metformin hydrochloride on cells. It may also help doctors understand how well~     patients respond to treatment. Giving metformin hydrochloride together with combination~     chemotherapy may kill more tumor cells.~   "
71446|NCT02122172|"~     This phase II trial studies how well afatinib dimaleate works in treating patients with~     urothelial cancer that cannot be removed surgically and has grown after treatment with~     standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the~     epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors,~     which may slow the growth of cancer cells or cause some of the cells to die.~   "
71447|NCT02122159|"~     Pathologic myopia is a major cause of legal blindness worldwide. In myopic macular~     degeneration (MMD), there is degeneration of the retinal pigment epithelial (RPE) layer, and~     associated photoreceptors, resulting in vision loss. There is currently no standard~     treatment for MMD.~      Transplantation of intact sheets of RPE and suspensions of isolated individual RPE cells as~     well as autologous translocation of RPE cells has been attempted as treatment for AMD. Human~     photoreceptors are comprised of two cell types-rods and cones. Both have a close~     relationship with the outermost retinal cells, the retinal pigmented epithelium (RPE). The~     RPE is located between the choroid and the photoreceptors. The RPE maintains photoreceptor~     function by recycling photopigments,delivering, metabolizing and storing vitamin A,~     phagocytosing rod photoreceptor outer segments, transporting iron and small molecules~     between retina and choroid, maintaining Bruch's membrane and absorbing stray light to allow~     better image resolution. In essence, the RPE layer is critical to the function and health of~     photoreceptors and the retina as a whole.~      Human PRE (hRPE) transplantation may be a viable option for treatment of degenerative~     diseases of the retina.~      MA09-hRPE cells are fully differentiated human RPE cells derived from embryonic stem cells.~     Transplanted hRPE cells prepared by Advanced Cell Technology have been studied in rodent~     models of macular degenerative disease. The data suggests that the subretinal injection of~     ACT's hRPE cell products rescues, or at least delays, loss of visual function in two animal~     models of retinal degenerative diseases.~      The main purpose of this study is to evaluate the safety and tolerability of MA09-hRPE~     cellular therapy in patients with Myopic Macular Degeneration (MMD). Another objective is to~     evaluate potential efficacy endpoints to be used in future studies of RPE cellular therapy.~   "
71448|NCT02122146|"~     To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
71449|NCT02122133|"~     The primary objective of this study is to gather data on the radiation exposure in patients~     treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their~     respective indications for use.This is a multicenter case review study of patients~     presenting with intracranial aneurysms who are treated with coil embolization therapy using~     the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90~     patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA~     will be enrolled.~   "
71450|NCT02122120|"~     Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with~     the ongoing economic crisis influencing health care, its cost-effectiveness has been~     questioned recently.~      Objective: The unique reimbursement situation in Poland enabled the otherwise ethically~     unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term~     feeding and the subsequent analyses of the clinical value of the latter and its~     cost-effectiveness.~   "
71451|NCT02122107|"~     In this study,the investigators are looking to see how older women who are survivors of~     breast cancer and either did or did not receive chemotherapy are affected by treatment,~     compared to older women who have never had cancer. Thinking and memory abilities normally~     decrease with age and the investigators want to see if the long-term effects of cancer~     treatments may make these problems worse. The investigators will also look at how thinking~     and memory abilities of older women are affected by genetics and smoking history. Genetics~     and other factors may affect the brain's chemicals or structure, and may either protect~     against the negative effects on thinking or make someone more at risk for them.~   "
71452|NCT02122094|"~     This study seeks to implement a sexual health promotion intervention for male sex workers in~     Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will~     increase testing, treatment and vaccination for sexually transmitted infections, including~     intentions of participants to engage in these services beyond the conclusion of the~     intervention. At the community level, the study hypothesis is that male sex workers will be~     more aware of sexual health care and more likely to access these services in the future.~   "
71453|NCT02122081|"~     This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC~     based organ-sparing marrow-targeted irradiation to condition patients with high-risk~     hematological malignancies who are otherwise ineligible to undergo myeloablative Total body~     irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target~     patient populations are those with ALL, AML, MDS who are either elderly (>50 years of age)~     but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity~     Index Score (HCT-CI) > 4). The goal is to have the patients benefit from potentially more~     efficacious myeloablative radiation based conditioning approach without the side effects~     associated with TBI.~   "
71454|NCT02122068|"~     Family dementia caregivers provide a needed service to relatives with dementia and to~     society, but are often at risk for consequences to their own health such as depression,~     reduced immune system function, and burnout. Central Meditation and Imagery Therapy (CMIT)~     is a novel group mindfulness and guided imagery intervention designed to help caregivers~     reduce depressive symptoms and cope with the stress of caregiving. A small study suggested~     that CMIT techniques are feasible for dementia caregivers, and resulted in a reduction of~     depressive and anxiety symptoms. The largest benefits were shown to occur within the first 4~     weeks, and were maintained at 3 months post treatment. The early benefits of CMIT were~     further described in a recent trial of CMIT for patients with recurrent depression, which~     demonstrated promising improvement in depressive symptoms, with the largest benefits~     occurring within the first 4 weeks. We have therefore shortened CMIT for caregivers from 8~     weeks to 4 weeks, and aim to study the effects of the four-week version (Central Meditation~     and Imagery Therapy, Short Term, CMIT-ST) on dementia caregivers with elevated depressive~     symptoms. We will conduct a pilot feasibility of CMIT-ST versus home relaxation practice~     with 24 dementia caregivers. Half of the caregivers will be randomly assigned to receive a~     relaxation recording, while the other half will receive CMIT-ST. After 4 weeks, the group~     assigned to the relaxation recording will then have the opportunity to participate in~     CMIT-ST.~      To measure the effects of CMIT-ST, we will obtain depression symptom ratings and~     questionnaires about psychological symptoms before and after CMIT-ST. We will also study the~     biological effects of CMIT-ST. We will do so by measuring brain activity, recording the~     pulse in order to determine variation in beat to beat intervals of the heart, and studying~     patterns of gene expression.~   "
71455|NCT02122055|"~     For the patient who passed the screen of weaning from ventilation, the traditional sedation~     drug such as propofol and midazolam should be decreased or stopped, then it would induce the~     stress response and agitation, such as hypertension,tachycardia etc. In order to resolve~     that problem, the sedation should be given again. but if renewed to sedation, it would cause~     prolonged sedation and ventilation duration.~      So as to resolve above issues, after the patient passed the screen of weaning, sedation is~     changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our~     study to compare the efficacy and safety of sequential sedation of propofol or midazolam and~     dexmedetomidine in mechanical ventilated ICU patients.~   "
71456|NCT02122042|"~     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,~     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low~     grade glioma tumor removal surgery~   "
71457|NCT02122029|"~     The purpose of the current study is to determine whether an intensive lifestyle intervention~     was as effective as surgery to treat morbid obesity nine years post-intervention.~   "
71458|NCT02122016|"~     Mechanical ventilation is widely used for ICU patients as a lifesaving procedure. However,~     it is associated with several complications, such as ventilator-associated pneumonia and the~     increase of hospital morbidity and mortality. To avoid such complications, we need to wean~     these patients off the ventilator as soon as possible. This must however be done at the~     right time to avoid other complications, such as the need for re-intubation. For this~     reason, it is important to have a specific weaning protocol, which will reduce the time on~     mechanical ventilation, and avoiding the need for re-intubation and other complications.~     Recently, an argument has developed as to which weaning protocol would be more appropriated,~     and whether a computer driven weaning protocol could have better results than the~     conventional weaning protocols focusing on daily screening and daily interruption of~     sedation followed by a spontaneous breathing test. Our objective is to compare mechanical~     ventilation times, weaning success up to 48 hours after extubation, re-intubation rates~     between a group with computer driven weaning protocol (SmartCare) versus a weaning protocol~     with daily weaning screens and spontaneous breathing trials in ICU patients ventilated for~     more than 24 hours.~   "
71459|NCT02122003|"~     -  Retrospective studies showed Sorafenib's efficacy as second line treatment after a~          Tyrosine Kinase Inhibitor (TKI).~        -  Currently there is no standard of treatment in 2nd line for patients treated in first~          line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).~        -  With this trial we evaluate the efficacy of sorafenib as second line of treatment in~          patients treated with pazopanib for mRCC.~   "
71460|NCT02121990|"~     The purpose of this study is to test the safety of the drug olaparib at different dose~     levels. It will be given with the standard initial chemotherapy for cancer as well as a drug~     called bevacizumab.~   "
71461|NCT02121977|"~     The aim of this study is to further evaluate the safety and efficacy of the Elevate®~     Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ~     prolapse in a controlled, post-market cohort study.~   "
71462|NCT02121964|"~     In this prospective, randomized study, investigators will look at the outcome of total hip~     arthroplasty through the anterior approach in regard to the surgical treatment of the~     anterior hip capsule. At this time, there are 2 different techniques: one is excising this~     capsule and the second one is cutting the capsule and repairing it at the end of the~     procedure. The investigators set out to determine whether incising or repairing the capsule~     will benefit the patients in terms of postoperative pain level, range of motion of the hip~     joint, joint stability, surgical time and blood loss. Both preserving and excising the joint~     capsule are accepted techniques in performing total hip arthroplasty. The Investigators~     hypothesize that capsulectomy may allow for reduction in operative time, provide superior~     surgical exposure, and increased range of motion after surgery. The influence on post~     operative pain and dislocation rate is unknown.~   "
71463|NCT02121951|"~     Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in~     which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the~     use of systemic analgesics and its accompanying untoward effects in those frail patients~     requiring PCN that is performed in the prone position.~   "
71464|NCT02121938|"~     The purpose of the study is to describe the dynamics of the microbiome in the premature~     infant as a means to adapt the premature infant gut to affect better health outcomes.~   "
71465|NCT02121925|"~     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment~     decisions of Surgeons when added to standard clinical-pathological parameters in patients~     with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed~     at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to~     Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be~     collected.~   "
71466|NCT02121912|"~     Participants will undergo a normal sleep study. They will be randomised to use either a FPH~     Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and~     pressure data, and complete questionnaires regarding satisfaction and ease of use at the end~     of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard~     masks for CPAP therapy in terms of ease of use, satisfaction and overall titration~     experience.~   "
71469|NCT02121873|"~     The objective of this study is to determine whether we can use minimally invasive techniques~     to gain access to exfoliated ductal epithelial cells for whole genome sequencing.~        1. To examine women with nipple aspiration, ductoscopy and ductal lavage and collect~          exfoliated cells from two ducts per woman.~        2. To collect a blood sample at the time of the examination in order to obtain the woman's~          baseline genomic sequence.~        3. De-identified samples will then have DNA and RNA extracted and whole genome sequencing~          and transcriptome analysis performed by Covance and Illumina.~        4. Comparisons will be made within a breast (two ducts) and between the duct and blood as~          well as between women.~   "
71470|NCT02121860|"~     This is an open-label, parallel-group study to compare the pharmacokinetics and~     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with~     mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C,~     respectively) and matched healthy volunteers with normal hepatic function.~   "
71471|NCT02121847|"~     This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion~     (Restasis®) in patients with dry eye disease.~   "
71472|NCT02121834|"~     This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This~     study will evaluate the safety and how well the body tolerates LY3050258. It will last~     approximately 14 weeks with a 2 week follow-up appointment after the last treatment with~     study drug.~   "
71473|NCT02121821|"~     The study aims to assess the effects of the SMS Mother Reminder system on use of health care~     in Uganda. A secondary aim of the study is to determine the behavioral factors and~     cost-effectiveness, as well as test the usability of the SMS Mother Reminder in Uganda.~   "
71474|NCT02121808|"~     The risk of complications associated with airway management in obese patients is~     significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the~     clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition~     to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical~     literature.~      This study is designed to evaluate the effect of different positions combined with different~     ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will~     evaluate the effect of different combinations of positions and ventilation modes on~     pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.~   "
71475|NCT02121795|"~     This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil~     fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide~     (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens~     containing FTC/TDF.~      This study will consist of a 96 week double-blind treatment period. After Week 96, all~     participants will continue on blinded study drug treatment and attend visits every 12 weeks~     until treatment assignments are unblinded. All participants will return for an unblinding~     visit and will be given the option to receive open-label F/TAF and attend visits every 12~     weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical~     development program.~   "
71476|NCT02121782|"~     The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to~     GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in~     Korean healthy adults.~      The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV)~     including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B).~     However, two antigenically distinct lineages of influenza B (Victoria and Yamagata)~     co-circulate annually in the United States. Predicting which lineage of influenza B will~     predominate during a season is challenging, and cross-protection by immunization against the~     other lineage is expected to be low. One proposed alternative is to produce a quadrivalent~     influenza vaccine (QIV) including an influenza B virus from each of the two circulating~     lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4~     vaccine components WHO recommends for use in the 2013-14 influenza season (northern~     hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the~     additional public health benefit compared with traditional TIV.~   "
71477|NCT02121769|"~     Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from~     fish oil. It will be used in an open label compassionate use treatment protocol, as an~     alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an~     effort to reduce and/or reverse parenteral nutrition associated liver disease. The study~     will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN~     dependence and PNALD.~   "
71478|NCT02121756|"~     The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in~     HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral~     load.~   "
71479|NCT02121743|"~     In France around 5,000 colostomies are performed after elective or emergency surgery. These~     colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of~     cases.~      To reduce the incidence of these outcomes, several methods have been proposed but the more~     pertinent consist in the use of a biological mesh during the stoma's conception.~      Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the~     prevention of parastomal hernia.~   "
71480|NCT02121730|"~     Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD).~     Between 2800 and 3000 kidney transplants are performed each year in France and more than 33~     000 patients are living with a functioning graft.~      Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity~     decreases as the distance from the day of transplantation. Unfortunately, treatment favors~     certain complications, including infectious and neoplastic. These represent a major cause of~     mortality in these patients. If the frequency of skin cancer is greatly increased in this~     population, that of solid tumors remains a concern. Approximately 20% of patients develop~     cancer after 10 years of graft , half non- skin cancers, the main risk factor is~     immunosuppressive therapy .~      The aim of the study is to evaluate, in a large population of patients treated in 4 regions~     ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in~     particular the nature of the immunosuppressive treatment) of developing a neoplastic~     complication, skin cancers and solid tumors, after renal transplantation.~   "
71481|NCT02121717|"~     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare~     with placebo.~   "
71482|NCT02121704|"~     Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the~     beginning of colonoscopy. MEI works by creating an electromagnetic field of very low~     intensity. By that the position of the endoscope can be displayed virtually on a monitor.~     The use of MEI has been shown to reduce the formation of loops and to ease the removal of~     existing loops during the investigation. Furthermore, as loops favour the occurrence of pain~     when the scope is moved forward, patients who underwent colonoscopy with MEI reported less~     pain at the end of the procedure.~      Sedation is used widely during colonoscopy for it has improved the tolerability of the~     investigation. Most of the patients demand for sedation. In Germany Propofol is recommended~     as the first-line sedative when endoscopy it is performed in an outpatient setting. The use~     of Propofol involves the danger of respiratory complications. One reason for the application~     of Propofol doses is the occurrence of pain during the investigation. We hypothesized that~     if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be~     needed. We therefore planned this prospective controlled trial.~   "
71483|NCT02121691|"~     The project will target two behavioral causes of obesity: a sedentary lifestyle and an~     unhealthy diet. The goal is to test a faith-based intervention among men and women who are~     members of participating Appalachian churches.~      The primary hypothesis being tested in this project is: The change in body mass index from~     baseline to one year follow-up in intervention churches will be greater than among~     comparison churches, such that the differential change will be negative on average.~   "
71484|NCT02121678|"~     Resistance and aerobic exercise has been shown to be effective for maintenance of muscle~     strength in patients with neuromuscular diseases.~      Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes~     in muscle strength during high intensive resistance training and changes in maximal oxygen~     consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in~     maintenance therapy with subcutaneous immunoglobulin.~      The hypotheses are that muscle strength and VO2-max are significantly increased during the~     training sessions.~   "
71485|NCT02121665|"~     Periodontal disease is an infectious disease resulting in inflammation within supporting~     tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies~     reveal that about 10% of the adult population suffer from severe periodontitis.It comprises~     of two distinct but interconnected etiologic components: the periodontopathic bacteria~     adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive~     responses to the causative bacteria and their metabolic products. In the arena of~     periodontics, the probiotics pose a great potential of plaque modification, halitosis~     management, altering anaerobic bacteria colonization, improvement of pocket depth, and~     clinical attachment gain.~      Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to~     Scaling and Root Planing, on clinical and biochemical parameters.~   "
71486|NCT02121652|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is~     effective for insomnia in lung cancer survivors.~   "
71487|NCT02121639|"~     The aim of the ProCAID study is to determine if the addition of the AKT inhibitor AZD5363 to~     docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in Metastatic~     castration resistant prostate cancer to a degree worthy of further investigation~   "
71488|NCT02121626|"~     The aim of the study is to identify how often gastrointestinal problems interfere with~     quality of life as a result of treatment for cancer with chemotherapy. We also want to~     identify the causes for these symptoms and see if simple treatments used for other~     gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for~     cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently,~     it can cause a whole range of physical side effects. Probably the most common side effects~     are those affecting the stomach and bowels. Vomiting used to be a major problem with~     chemotherapy but research discovered a whole series of new treatments so that severe~     vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole~     series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea,~     needing to rush to the lavatory and opening the bowels very frequently. The causes for these~     symptoms have hardly been studied even though they sometimes affect people quite badly. In~     our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12~     years, we have pioneered new methods for dealing with symptoms which affect the bowel after~     radiotherapy. We would like to extend these methods to people having chemotherapy. We have~     identified several easily treatable causes for these symptoms after radiotherapy, which~     previously were often ignored. We believe that some of these causes also occur in people~     having chemotherapy and if we knew how often they do occur we could focus on improving~     treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms~     occur during chemotherapy. In people who are troubled by any or some of these symptoms we~     will arrange simple series tests which could sort out why these symptoms occur and we will~     record how they respond to treatment.~   "
71489|NCT02121613|"~     The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating~     subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using~     Tamsulosine LP 0.4 mg as a reference treatment.~   "
71490|NCT02121600|"~     Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess~     response to treatment in men with castration resistant prostate cancer (CRPC).~      It is hypothesized that these novel biomarkers will better identify evaluable lesions prior~     to therapy and identify response to treatment (or lack thereof) earlier in the treatment~     period, providing a better guide for treating men with CRPC.~   "
71500|NCT02121470|"~     Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients~     which is associated with increased morbidity and mortality as well as high costs of medical~     care.~      NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker,~     that is expressed in several tissues including the kidneys. Renal expression of NGAL is~     dramatically increased in kidney injury from a variety of causes, and NGAL is released into~     both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early~     and sensitive biomarker of kidney injury, with the potential to assist clinicians in~     managing patients at risk of kidney injury.~      This study is designed to validate the assigned NGAL cutoff value by comparing to clinical~     diagnosis of AKI as determined by current clinical practice in the US.~      The study sites will enroll consecutive ICU patients. Patients are given standard clinical~     care and lab-work. Each day, one additional urine and two additional plasma samples will be~     drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL~     measurements.~      The duration of each subject´s participation will be until discharge from the ICU, or for a~     maximum 8 days, whichever comes first. In addition serum creatinine values will continue to~     be collected manually from the hospital data system for 48 hours after discharge from the~     ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected~     while the patient is still in the ICU).~      250 subjects will be enrolled in total at the three investigator sites. At least 40 patients~     must be enrolled at each site.~      The NGAL value will be matched to the clinical diagnosis of acute kidney injury (AKI) as~     specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person~     adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are~     blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values.~      A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as~     assigned by the majority of the adjudication panel will be conducted.~   "
71745|NCT02118272|"~     The aim of this study is to assess the clinical, radiographic and patient-reported outcome~     measures (PROMs) after total knee replacement with Physica KR, define the survivorship of~     the implants and identify possible risk factors that may lead to failure.~   "
71491|NCT02121587|"~     The purpose of this pre and post intervention observational study is to evaluate~     patient-reported outcomes from an new clinical course which integrates Mindfulness and~     Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic~     manual therapy treatment for patients with persistent pain.~      It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in~     progress, June 2013 to August 2014), a course was developed for self-referring patients~     attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded~     to evaluate outcomes for patients attending National Health Service (NHS) General~     Practitioner (GP) surgeries in South East London.~      The intervention consists of a pre-course screening interview; a structured course of six,~     weekly, one-hour treatment sessions for individual patients; and an optional follow-up~     interview after three months.~      The evaluation study is being conducted by an independent study team from the National~     Council for Osteopathic Research. Patients complete a set of standardised questionnaires~     before the course and after six months to assess self-reported changes in quality of life,~     well-being, activity levels, mindfulness and use of health resources. A sample of patients~     will be invited to provide consent for a treatment session to be observed and/or recorded,~     or to attend a follow-up interview after six months, to evaluate the quality of course~     delivery. This is an observational study of patient-reported outcomes from a new~     intervention in a single cohort of patients, so there is no formal study hypothesis but it~     is anticipated that outcomes will include increased quality of life, well-being, and active~     engagement with valued activities.~   "
71492|NCT02121574|"~     Background When a patient is anesthetised and undergoes an operation, their body temperature~     falls. Managing a body temperature properly by keeping it within normal limits has been~     shown to improve recovery from surgery.~      A vital part of managing temperature is being able to measure it properly. There are several~     ways of doing so, which consist of invasive methods such as temperature probes in the~     oesophagus and bladder, and non invasive methods such as infrared scanners and ear canal~     probes. During an operation, temperature changes as small as 0.5 °C can affect outcomes but,~     currently, only invasive methods are reliable enough to detect this. Oesophageal probes~     can't be used in patients who are not anaesthetised during their operations, and it is~     inappropriate to insert a urinary catheter should it not be otherwise needed.~      The purpose of this study is to look at two new methods of measuring a patient's temperature~     which would help us in these situations. The first is called zero-flux thermometry and~     involves placing an adhesive pad to the forehead, which gives constant measurement of a~     patient's core temperature. The second involves swallowing an ingestible capsule that is no~     bigger than a normal pill. This technique has been very useful in research tracking a~     patient's core temperature as they are transferred through different areas over a longer~     period of time. Whilst these two methods are potentially very useful, they have never been~     tested on hospital patients.~      Aims:~      The investigators want to determine whether readings from these thermometers are accurate~     enough to be used in patients before, during and after surgery. Should they prove to be~     sufficiently accurate it will allow us to improve patient care through both clinical~     practice and research.~      Plan:~      During operations, temperature is routinely measured in line with NICE guidelines with a~     thermometer placed in the nose or oesophagous. The investigators will not be changing~     routine practice in any way, but checking measurements from the new devices against the~     proven, routine ones.~      The investigators plan to record measurements from each device every minute throughout the~     operation in 20 patients. The investigators will then perform statistical tests to check~     their accuracy.~      Study Hypothesis: Zero flux and ingestible thermometers are not significantly different at~     detecting patients body temperature than oesophageal temperature probes~   "
71493|NCT02121561|"~     When people feel shame, they experience negative thoughts about themselves (I'm a bad~     person) and urges to avoid others. Shame is related to many psychological problems, such as~     depression, social anxiety, and borderline personality disorder (BPD). Because there are~     currently no well-tested treatments for shame, this study will examine the utility of~     Self-Acceptance Group Therapy (SAGT). SAGT is short-term group therapy that addresses shame~     specifically. Changes in shame, mood, and behavior will be examined over the course of~     treatment and a one-month follow-up.~      Based on theory and existing evidence, Hypothesis 1a is that individuals with elevated~     initial levels of shame will report improvements on all outcome measures (e.g., reductions~     in trait shame, increases in self-acceptance) from pre-treatment to post-treatment, and~     Hypothesis 1b is that these gains will be maintained at follow-up one month after treatment~     completion.~   "
71494|NCT02121548|"~     Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened~     for cervical cancer than the general population. One promising approach is outreach~     strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW~     programs, many women remain unscreened. In our NCI Community Networks sponsored project, we~     are testing an approach that combines CHWs with self sampling for the human papilloma virus~     (HPV) as a screening strategy among such hard to reach populations.~   "
71495|NCT02121535|"~     The study will be performed as an open-label, randomised, single-dose, two-sequence,~     four-period replicated crossover design. A total of 72 Japanese healthy male subjects will~     be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet~     once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each~     period. The length of admission will be 7 days in each period.~   "
71496|NCT02121522|"~     The present trial will use an open label design to investigate the effect of BI 144807 on~     central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD~     patients. A further objective is to collect data on adverse events, vital signs, ECG and~     clinical laboratory parameters of BI 144807 in the same patient group.~   "
71497|NCT02121509|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release.~   "
71498|NCT02121496|"~     1. Investigators aim to assess a novel behavioral intervention (currently approved in~          Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral~          changes in young infants to reduce the risk of postpartum depression in a group of low~          income women. More specifically, investigators aim to determine if a behavioral~          intervention targeting maternal caregiving of young infants can increase infant sleep~          and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of~          postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve~          the quality of mother-infant interaction and subsequent child development.~          Investigators will study:~             1. The feasibility of applying this protocol with a low SES population~             2. The effectiveness of the intervention compared to usual care~             3. If the effects of the intervention can be detected in assessments of the quality~               of mother-infant interaction and infant neurocognitive development~        2. Investigators aim to determine whether this behavioral intervention can affect infant~          development as measured by neurodevelopmental assessments and cortisol reactivity at 4~          months of age.~   "
71501|NCT02121457|"~     Some studies reported that selenium status is associated with cognitive function. However~     only a few reports have investigated whether selenium supplementation can benefit cognitive~     performance and in most of them selenium supplementation was not exclusive. Also, none of~     those reports have used foods rich in selenium as a source of supplementation. Thus, the aim~     of our study was to investigate whether the consumption of Brazil nuts improves cognitive~     function. We hypothesized that the daily consumption of Brazil nuts would have benefits on~     selenium status, increase antioxidant enzyme activity and improve cognitive function in~     older adults with MCI.~   "
71502|NCT02121444|"~     This study aims to investigate adherence to therapy among patients treated with Betaferon~     who are using the BETACONNECT autoinjector.~   "
71503|NCT02121431|"~     This trial addresses a serious and all-too-frequent public health problem, namely~     early-onset disruptive behavior problems in young children. The focus is on testing an~     online treatment program which empowers parents to help their children to improve their~     mental health and behavioral functioning. At the conclusion of the study, the investigators~     will know whether the online-delivered program works as well as an established~     staff-delivered program, with respect to child disruptive behavior problems, parenting,~     parent/family stress, consumer satisfaction, and value analysis.~   "
71504|NCT02121418|"~     This clinical trial studies decitabine and cytarabine in treating older patients with newly~     diagnosed acute myeloid leukemia, myelodysplastic syndrome that is likely to come back or~     spread to other places in the body, or myeloproliferative neoplasm. Drugs used in~     chemotherapy, such as decitabine and cytarabine, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     decitabine and cytarabine may work better than standard therapies in treating cancers of the~     bone marrow and blood cells, such as acute myeloid leukemia, myelodysplastic syndrome, or~     myeloproliferative neoplasm.~   "
71505|NCT02121405|"~     The purpose of this study is to determine whether primary radiotherapy can be omitted for~     the locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative~     circumferential margin.~   "
71506|NCT02121392|"~     The purpose of this study is to further investigate the efficacy of adductor canal nerve~     blocks for pain management after total knee replacement. Specifically we are studying~     adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination~     that has not been extensively researched before. Our question is whether combining these~     modalities will enhance patient satisfaction after surgery and accelerate patients'~     readiness to discharge.~   "
71507|NCT02121379|"~     Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who~     undergo cytotoxic chemotherapy.~      We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.~   "
71508|NCT02121366|"~     The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided~     ethanol ablation of an insulinoma.~   "
71509|NCT02121353|"~     The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis~     (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible~     participants will receive either PF582 or Lucentis, by injection into one eye on study Day~     1, 28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the~     study participants will undergo the following procedures: height, weight and vital signs~     (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical~     history and concomitant medications; adverse event monitoring; physical examinations; eye~     tests (reading chart, measurement of retinal thickness [via pictures of the retina] and~     examination of the eye's blood vessels, via pictures taken following injection of a dye into~     the arm), blood collection and a urine pregnancy test, where applicable.~   "
71510|NCT02121340|"~     In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a~     novel mental health/ophthalmologic intervention called, Collaborative Care for Depression~     and Diabetic Retinopathy (CC-DDR), which aims to treat depression and lower HbA1C in older~     African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.~   "
71511|NCT02121327|"~     It has been reported that stroke is the first cause of becoming bedridden, and its~     cumulative recurrence rate in 5 years is approximately 35%. There is a high probability that~     patients reduce or discontinue medications by self-determination, leading to a high risk of~     stroke recurrence in these patients. Comprehensive and long-term patient educations~     ameliorating their self-management are important making patients possible to be managed~     according to the guidelines for their risk factors. Using disease management programs~     created for each of risk factors according to clinical practice guidelines, the influence of~     those programs were evaluated for the prevention of stroke recurrence in this Disease~     Management Program Stroke Trial.~   "
71512|NCT02121314|"~     WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug~     concentrations are too low; on the other hand: if this is not tolerated, drugs could also be~     taken with food.~      Do lower drug concentrations - with improved adherence to therapy - outweigh the~     disadvantage of lower drug blood concentrations over time? How exactly do the drug~     concentrations over time (pharmacokinetics) compare between fasting and fed conditions,~     especially in the early stage of TB treatment when patients are relatively sick, and~     relatively poorly tolerate TB drugs?~   "
71513|NCT02121301|"~     The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and~     effective compared to placebo for the treatment of the signs and symptoms of dry eye~     syndrome.~   "
71514|NCT02121288|"~     The purpose of the study is to assess the effect of blood flow to the heart when subjects~     are treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the~     blood from clumping together) in patients with Peripheral Artery Disease (PAD).~   "
71542|NCT02120924|"~     The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic~     Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of~     moderate facial rosacea.~   "
71746|NCT02118259|"~     The main objective of the study is to show that the multidisciplinary review of drug~     prescriptions changes the adverse drug event (ADE) geriatric risk score (according to~     Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital~     Residence for Dependent Elderly.~   "
71515|NCT02121275|"~     Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients~     who are anaesthetized and intubated. The goal of the present prospective study is to detect~     atelectatic areas in the perioperative period in the lungs of patients undergoing elective~     laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound~     (LUS) as the experimental method will be compared to the results of Electrical Impedance~     Tomography (EIT) as the reference technique for the detection of atelectasis. A device for~     peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in~     ventilation. The investigators want to confirm or disprove former findings of the appearance~     of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of~     atelectases.~   "
71516|NCT02121262|"~     This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser~     photocoagulation in patients with diabetic macular edema (DME).~   "
71517|NCT02121249|"~     The purpose of this study was to quantify potential short- and long-term benefits of~     robotically-guided minimally invasive spine surgery in instrumentation of degenerative~     lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a~     matching cohort of control patients performed using conventional freehand technique.~   "
71518|NCT02121236|"~     This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography~     in detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis~     of contents will be compared to those findings obtained from the histological examination~     (i.e. the gold standard). The second part of this study will examine the measuring accuracy~     by comparing ultrasonography-based 3D measurements with those obtained from CBCT images of~     the lesion assuming that CBCT 3D measurements are the gold standard.~   "
71519|NCT02121223|"~     To evaluate the effective and safety of post-dilatation in patients with acute ST segment~     elevated myocardial infarction undergoing primary percutaneous intervention after thrombus~     aspiration assessed by optical coherence tomography to examine stent Incomplete apposition~     and strut coverage in patients treated with drug-eluting stents .~   "
71520|NCT02121210|"~     Primary Objective:~      To evaluate the immunogenicity of sarilumab administered as monotherapy.~      Secondary Objectives:~        -  To evaluate the other safety aspects of sarilumab administered as monotherapy.~        -  To assess the exposure of sarilumab administered as monotherapy.~   "
71521|NCT02121197|"~     To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in~     clinical practice management of patients with DME.~   "
71522|NCT02121184|"~     Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring~     fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia~     used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the~     variables which could affect fetal heart rate patterns at the time of initiation of~     analgesia, such as fluid administration and oxytocin management, could help us provide~     better care for our patients and their fetuses.~      Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin~     administration will have fewer non-reassuring fetal heart rate (FHR) changes.~   "
71523|NCT02121171|"~     The objective of this prospective randomised study is to compare the efficacy and safety of~     ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital~     glaucoma cases, the efficacy being the primary objective and the safety being the secondary.~     The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen~     matrix implant implantation in congenital glaucoma is a safer procedure and may yield better~     results than combined trabeculotomy-trabeculectomy approach.~   "
71524|NCT02121158|"~     The overall aim of this trial is to study the safety and efficacy of ICD implantation as a~     primary prevention strategy of sudden cardiac death in patients 70 years and older. This~     study will assess the many competing factors involved with ICD implantation including 1) the~     impact on mortality, especially in the context of a declining rate of sudden death with~     advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3)~     the impact on quality of life.~   "
71525|NCT02121145|"~     In a recent controlled study, the investigators explored cross-reactive immune responses~     against different Salmonella spp. in healthy volunteers immunized with either the oral~     (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331). In the present~     study immune responses will be studied in a group receiving both of these vaccines and in~     the previously immunized volunteers after booster immunization (same groups receive same~     vaccines 2-4 years after primary immunization).~   "
71526|NCT02121132|"~     The main objective of this study is to establish a national pediatric obesity registry known~     as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical~     data from individual comprehensive pediatric weight management programs around the United~     States for overweight and obese youth.~   "
71527|NCT02121119|"~     In practice ambulatory orthopedic surgery, one of the problems of most difficult solution is~     adequate control of postoperative analgesia. Pain is a frequent cause of consultation and~     unscheduled readmissions in this group of patients.~      The use of continuous peripheral nerve blocks are an effective tool in postoperative~     analgesia.~      In this connection, most of the studies of continuous infusions of local anesthetics by~     perineural catheters have been made with bupivacaine, levobupivacaine, and ropivacaine~     However, it has been found that lidocaine action lasts less, has lower cost and is less~     toxic than longer-acting agents.~      The investigators aim is to compare the effectiveness of lidocaine versus bupivacaine~     continuous popliteal sciatic blockade ambulatory elastomeric pump.~   "
71562|NCT02120664|"~     This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission~     Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.~   "
71682|NCT02119091|"~     A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study:~     Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy~     Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the~     difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese~     group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary~     Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin~     plasma concentration between Chinese group and Caucasian group.2)To compare slopes of~     Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and~     Caucasian Volunteers.~   "
71528|NCT02121106|"~     With medication, many individuals with psychosis experience a remission from hallucinations~     and delusions, the most salient aspects of the disorders. However, alleviation of these~     symptoms is not associated with recovery of everyday functioning in important areas like~     working, socializing, maintaining the household, and recreational pursuits. The reason these~     difficulties with functioning persist is that psychotic disorders are associated with~     considerable difficulties with cognitive functions such as attention, memory, and planning.~     Cognitive impairments persist even when the delusions and hallucinations are treated, and in~     fact account for most of the persistent impairments in functioning.~      Recently, psychological treatments called Cognitive Remediation have been developed and~     tested in research settings, where techniques that train the brain to process information~     more efficiently result in very large improvements in cognition. However, there are two~     major hurdles remaining as investigators attempt to determine how this treatment can~     graduate from research laboratories to become a widespread clinical treatment. First,~     cognitive remediation in research settings is very intensive: it requires frequent visits~     with specialized therapists who deliver the treatment to groups of patients. This makes it~     quite difficult for people with psychosis, who might not have the financial means or~     motivation to travel and who might be experiencing symptoms that make it unlikely that they~     will attend groups, to participate fully if the traditional research techniques were~     directly transported to a clinical setting. The second hurdle is that even though cognitive~     remediation improves cognition, it does not always transfer to everyday behavior changes.~     Investigators recently found that this transfer to functioning is more meaningful and~     durable when using additional techniques that teach people skills such as being aware of~     your own thinking and to use multiple, flexible problem solving strategies.~      The goal of this project is to address these limitations by testing a new development in the~     treatment: delivering cognitive remediation to participants in their homes, with cognitive~     exercises and therapist support provided online. The techniques are the same as successful~     in-session cognitive remediation, but those with psychosis can engage in the intervention at~     home and therapists will be able to service more individuals with online discussion forums~     and video demonstrations. The more people engage in cognitive remediation, the better the~     outcomes. This is particularly true for receiving a consistent dose of exercise, rather than~     in longer, once per week sessions typical of traditional psychotherapies. The online~     component of this program provides patients with the ability to engage in a higher and more~     consistent rate of exercises and skill development, and we will explore whether the amount~     and continuity of engagement is associated with larger and broader improvements.~   "
71529|NCT02121093|"~     The vibration stimulation is regarded as a new method of training and therapy to change~     afferent parts and cortical projections, which are important for motor control. This study~     aims to check effects of different frequency parameters for electrical cortical potentials~     and electrical muscular potentials in healthy young adults. 80 volunteers will participate~     in the study, and they will be randomly subdivided in four groups for trials. The~     methodology consists of electroencephalographic and electromyographic assessment before and~     after 15-minute vibration application with a digital vibratory pad.~   "
71530|NCT02121080|"~     This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety,~     tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in~     cohorts of healthy adult volunteers.~   "
71531|NCT02121067|"~     This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for~     contraception. The Mirena® is an FDA approved intrauterine contraceptive device that~     provides contraception for 5 years with excellent effectiveness. Women enrolled in this~     study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The~     participants will be followed at 6-weeks and 6-months postpartum for study visits to~     evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed~     at six-months postpartum, and participants will be able to keep their LNG-IUS following~     study completion.~   "
71532|NCT02121054|"~     The purpose of this study is to evaluate the prognosis of patients with resistance to~     antiplatelet agent and develop tailored treatment model for patients with coronary artery~     disease.~   "
71533|NCT02121041|"~     The purpose of this study is to compare the effectiveness of ambulatory blood pressure~     monitoring to usual care (blood pressure measurement in the office) in diagnosing and~     managing hypertension.~   "
71534|NCT02121028|"~     The objective of this study is to determine the mechanisms of stroke in patients with~     Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of~     antegrade flow through the stenotic artery, distal tissue perfusion to the affected~     territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging~     biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective~     multicenter study will enroll 175 patients with recently symptomatic high-grade IAD.~     Patients will be studied within 21 days of the index event (allowing appropriate time to~     arrange for diverse imaging modalities), with the following advanced neuroimaging techniques~     to elucidate mechanisms of recurrent ischemia:~        -  Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through~          the stenotic artery.~        -  Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue~          perfusion.~        -  Vasomotor reactivity by Transcranial Doppler using the breath-holding technique~          (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the~          affected artery;~        -  Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery~          embolism that reflects plaque instability.~      Patients will receive standardized medical management and its effectiveness on blood~     pressure, lipid, and glycemic control will be monitored.~      The primary outcome is recurrent stroke in the territory of the stenotic artery during a~     1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI~     in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack~     (TIA) in the distribution of the stenotic artery during a 1-year follow-up period.~      Patients will be recruited at various sites that will be trained and certified on the~     imaging techniques employed. Raw imaging data will be interpreted centrally.~   "
71535|NCT02121015|"~     The overarching aim of this project is to develop and pilot an innovative online~     intervention (Share) that integrates an Individual Internet Intervention (III) and an~     Internet Support Group (ISG) in preventing Postpartum Major Depression (PPMD). To establish~     that supportive accountability is a critical component of the intervention, Share will be~     compared to an III alone, and an ISG without the III components.~   "
71536|NCT02121002|"~     To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical~     Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.~   "
71537|NCT02120989|"~     We will undertake initial development of a new behavioral sleep intervention (i.e.,~     partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the~     gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact~     on subjective and objective sleep and quality of life in a clinic-based sample. Secondary~     aims will examine treatment adherence and maintenance of therapeutic gains as well as~     relationship satisfaction and broader psychiatric functioning.~   "
71538|NCT02120976|"~     The purpose of this study is to evaluate the safety, tolerability, and PK of single oral~     doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to~     evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2~     diabetes mellitus subjects.~   "
71539|NCT02120963|"~     Aim: To study if a person-centered physical therapy intervention program contributes to~     diminished fatigue in people with Rheumatoid Arthritis (RA).~   "
71540|NCT02120950|"~     To collect data reflecting the efficacy and safety of aflibercept with and without~     photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy~     subtype of wet age-related macular degeneration~   "
71541|NCT02120937|"~     Mindfulness group therapy can help children with mood irregularities and family history of~     bipolar disorder.~   "
71543|NCT02120911|"~     Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor~     outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the~     setting of advanced disease and disease and safety of combining trastuzumab with~     chemoradiation in the curative setting has been established. In breast cancer, the added~     value of pertuzumab to standard treatment with trastuzumab has been shown both in the~     neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to~     explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in~     HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this~     setting is limited, and no data are available on the safety of this combination prior to~     major surgery, we propose to first conduct a feasibility study with this treatment stratgy.~     When the results of this study show that this treatment strategy is feasible, we will~     subsequently design a prospective study with efficacy as primary endpoint.~   "
71544|NCT02120898|"~     The purpose of this study it so compare the safety and efficacy profiles of a generic~     imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of~     actinic keratosis.~   "
71545|NCT02120885|"~     Gastric cancer is a major health issue and one of the most common malignance in Korea. With~     the popularization of cancer screenings and increasing the average lifespan, the number of~     gastric cancer patients is increased. In the past, most of the research were concerned with~     survival and recovery after cancer surgery. However, as the medical technology had been~     developed and recovery rate and survival rate of cancer patients had risen, the patients~     wanted to return to a daily life and desire for participation for leisure. In other words,~     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as~     like prior to cancer surgery.~   "
71546|NCT02120872|"~     The purpose of the present study was to investigate the efficacy of autologous Platelet rich~     fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment~     of three wall intrabony defects in comparison to OFD alone.~   "
71547|NCT02120859|"~     We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR -~     guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare~     metal stenting for elective PCI of de novo coronary lesions.~   "
71548|NCT02120846|"~     Forty patients will be assigned to either a training group (12 wk unilateral knee extension~     flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients~     will maintain daily routines and any prescribed rehabilitation program. Established methods~     to assess muscle and cognitive function will be employed before and after the intervention.~      This project will disclose whether an exercise paradigm, known to improve muscle function~     and increase muscle volume in healthy populations, will induce similar adaptations in~     chronic stroke patients. More importantly, this study will elucidate if any impairment in~     cognitive function caused by stroke, can be reversed with this particular resistance~     exercise regimen.~      The information gained from this project will have significant implications and aid in~     advancing rehabilitation programs and exercise prescriptions for men and women suffering~     from stroke. The overall objective of this research is to promote independence and hence~     quality of life in these patients.~   "
71549|NCT02120833|"~     This study is for infants with mild to moderate dry and itchy skin. This study will involve~     going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a~     dermatologist to determine if they have atopic dermatitis and have an active mild to~     moderate eczema wound. Participant's parents/guardians will be asked a few questions to~     determine if their child qualifies for the study.~      Then all participants' caregivers will complete a questionnaire at the beginning of the~     study. The child's skin will be examined to rate the level of their eczema and a trained~     examiner will grade the looks and symptoms of their eczema. All parents or guardians will be~     instructed how to apply the test product and how to record usage on a diary card and then~     apply the test product. The test product will be applied at least 2 times per day or more as~     needed on all body areas, including the face affected throughout the study.~      One digital picture will be taken of one eczema wound. Another digital picture will be taken~     of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and~     Day 14.~      Once product is applied the skin will be examined for any adverse events and all~     participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.~   "
71550|NCT02120820|"~     The aim of this study is to evaluate the effectiveness of multisensory environment (MSE)~     and/or massage therapy (MT) in residents with severe and profound intellectual disabilities~     (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual~     care environment, or usual care with attention.~      Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and~     MSE on relaxation and reducing challenging behaviours, the following null hypotheses are~     suggested:~        1. There will not be any differences on reducing heart and respiration rates between~          MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week~          follow-up.~        2. There will not be any differences on adaptive behaviours and levels of alertness~          between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a~          2-week follow-up.~        3. There will not be any differences on frequency and severity of challenging behaviours~          between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a~          2-week follow-up.~   "
71551|NCT02120807|"~     The purpose of this study is to test the safety of certolizumab when it is given with the~     chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy~     drugs used in the treatment of lung cancer. The investigators want to find out what effects,~     good and/or bad, certolizumab has on the patient and lung cancer.~   "
71552|NCT02120794|"~     The study objective is to demonstrate that home use of Threshold Suspend (TS) is not~     associated with glycemic deterioration in pediatric patients with type 1 diabetes, as~     measured by change in A1C.~   "
71553|NCT02120781|"~     The objectives of this study are to assess the safety of azficel-T treatment for dysphonia~     related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment~     of dysphonia related to vocal fold function.~   "
71581|NCT02120417|"~     This is a randomized, double-blind, placebo controlled clinical trial comparing the overall~     survival of women with advanced or metastatic HER2-negative breast cancer who receive~     treatment with capecitabine in combination with ruxolitinib versus those who receive~     treatment with capecitabine alone.~   "
71554|NCT02120768|"~     The randomized, controlled trial is aiming at comparing local control rate between two~     surgical resections, barrier resection and local wide resection with 1cm or equivalent~     normal tissues. This is based on the fact that the goal of local surgical treatment is to~     remove the tumor with negative margin and best functional outcome, but there is a lack of~     standard principle of surgery. Some surgical oncologists recommended enlarging surgical~     field in which case the associated muscle was removed from origin to insertion, the previous~     surgical scar and radiation field were also grossly remove, though there would be extra~     trauma and unacceptable function impairment, they believe that patients would benefit from~     big operations. Most other surgeons would perform a sarcoma resection through normal~     tissues, and reported a fair local control as long as a negative margin was obtained. As~     reported by various authors, recurrent STSs are associated with higher risk to develop~     further recurrence as compared to primary STSs, thus, efforts should focus on this category~     of STSs to improve outcome.~   "
71555|NCT02120755|"~     This research project is testing a product called AmnioClear™ which is an amniotic membrane~     graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human~     amniotic membrane is regulated solely under section 361 of the Public Health Service Act.~      The purpose of the study is to see if this treatment works to accelerate the healing time of~     chronic wounds.~   "
71556|NCT02120742|"~     This study seeks to evaluate the impact of a text-message (SMS) program delivered to~     motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit~     Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. In~     this study, the investigators will conduct a randomized controlled trial to see if this~     program leads to increased helmet use over time. The investigators will recruit between~     350-400 motorcycle drivers to receive the text program. The investigators will obtain each~     of their cell phone numbers, and the participants will be split into three groups. The first~     group will receive reminders framed as social norming (ie Most of your peers wear~     helmets). The second group will receive reminders framed as fear appeals (ie Not wearing~     your helmet increases your chance of dying in an accident). The third group will act as the~     control and receive texts that relate to general road safety, but not helmet use. All groups~     will receive the same general road safety information being delivered to the control arm.~     The purpose of sending different types of reminders is to assess which type of messages are~     more likely to cause a motorcycle driver to regularly wear their helmet. The investigators~     will survey the participants at the initiation of the study and after weeks 3 and 6 during~     the study, asking about their helmet use. This will be a short survey, and any personal~     information gathered during the study (ie, phone numbers), will be securely stored so as to~     protect their privacy.~   "
71557|NCT02120729|"~     This Randomized Clinical Trial (RCT) compares outcomes in 1500 patients with major~     depressive disorder (MDD) treated according to the patient's CYP2D6 genotype status (N=1000)~     versus empiric standard-of-care psychotropic therapy (N=500). The hypothesis is that~     provision of medication based on the functional status of the patient's CYP2D6 enzyme~     inferred from genotype results within 48 hours of admission to treating clinicians will,~     through refined selection of psychotropic medication during hospitalization, decrease length~     of psychiatric hospitalization stay and decrease the rate of 30 day re-admission.~      The trial setting is the Hartford Hospital Institute of Living (IOL). The IOL operates the~     Clinical Evaluation and Monitoring System (CEMS), an innovative electronic messaging system~     developed by Co-Investigator Dr. J.W. Goethe. The Hartford Hospital Genetics Research Center~     (GRC) performs the genotype testing. CYP2D6 genotype analysis detects all known~     polymorphisms that result in an enzyme with sub-normal or supra-normal function. In this~     study, CEMS transmits clinically actionable guidance based on the patient's genotype to the~     clinician, advancing the medication alerts in real time.~      The RCT will test the effects of timely incorporation of medication recommendations based on~     CYP2D6 genotype into CEMS. The RCT assigns 500 patients to standard therapy (Group S) for~     whom CYP2D6 genetic information is determined but not transmitted to the treating clinician,~     allowing psychotropic therapy to be empirically determined, and 1000 to genetically guided~     therapy (Group G) where genotyping result and treatment recommendations are furnished via~     CEMS to the clinician within 24 hours of DNA sampling and 48 hours of admission. For~     patients in Group G who are poor or rapid metabolizers, medications primarily metabolized by~     the CYP2D6 enzyme are proscribed.~      The primary outcome is hospital length of stay and the secondary outcome, the frequency of~     30 day hospital readmission. Additional genetic stratification of both Group S and Group G~     will allow investigation of specific psychotropic usage.~      The expected benefits are 1) quantitative understanding of the effect of providing CYP2D6~     pharmacogenetic information on length of hospitalization, 30 day readmission rate, and~     associated costs; and 2) objective benchmarking for the comparative effectiveness of CYP2D6~     genotyping for guiding psychotropic therapy.~   "
71558|NCT02120716|"~     The objective of this study is to develop and determine feasibility of a computer-delivered~     intervention (Health Check-up for Expectant Moms) approach to target women at risk for~     HIV/STIs and alcohol/drug use during pregnancy through two phases of testing:~      The development aims of this study are to:~        1. Develop intervention content.~        2. Perform a small open trial (n = 10) of the computer based intervention (Health Check-up~          for Expectant Moms) to assess feasibility of recruitment of target population and~          acceptability of the intervention and study procedures via participant report of ease~          of use, helpfulness, and overall satisfaction.~      The pilot study aims of this study are to:~        1. Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for~          HIV/STIs and alcohol/drug use) pregnant women.~        2. Determine:~             1. feasibility of the computer based intervention~             2. acceptability via participant report of ease of use, helpfulness, and overall~               satisfaction~             3. evidence for the hypothesized effects on outcomes: the proposed intervention, in~               comparison to a time-and-attention-matched control group, will produce reductions~               in HIV/STIs risk behavior during the follow-up assessment at 4 months.~        3. Determine if the intervention condition, relative to control, will produce reductions~          in alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).~        4. Determine effects on process variables: if participants assigned to the intervention~          condition, relative to control, will demonstrate greater increases in knowledge,~          readiness to change and risk perceptions.~   "
71559|NCT02120703|"~     Pregabalin is claimed to have superior analgesic effect at lower doses and better~     pharmacological profile as compared to gabapentin esp. in perioperative pain control after~     major surgeries like intervertebral disc surgery.~      The investigators found that pregabalin is equivalent to gabapentin for relief of~     post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.~   "
71560|NCT02120690|"~     To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS)~     for fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation~     circuitry. The investigators hypothesized that patients with fibromyalgia might experience a~     clinically significant reduction in daily pain if investigators were to administer TNS in a~     manner similar to experimental antidepressant protocols.~   "
71561|NCT02120677|"~     This research is being done to study the molecular effects of topically applied itraconazole~     ointment on the growth of basal cell carcinomas.~   "
71563|NCT02120651|"~     The diagnosis of tympanic perforation reaches a high number of records in~     otorhinolaryngology services worldwide. Most of the tympanoplasties are performed in~     patients whose cause of perforation and hearing loss was chronic otitis media; this entity~     affects the population between 0.5 to 30% , the statistics mention more than 20 million~     people with this disease in the world. Since the introduction of tympanoplasty in the second~     half of the nineteenth century there have been numerous publications nationally and~     internationally about various experiences and new techniques. Including the use of fibrin~     monomer . This procedure is usually performed with the use of hemostatic sponge and recently~     with fibrin monomer, both materials are part of the basic input and surgical hemostatic~     agents. In this hospital are performed on average 110 tympanoplasty per year which has a~     percentage of non- integrity of the graft in the case of microscopic tympanoplasties using~     hemostatic sponge of 16% which is similar to the index of lack of integrity of the graft in~     microscopic tympanoplasties reported worldwide (18%), with the recent addition to the~     service of fibrin monomer, was necessary to evaluate if this material contributes to the~     integrity of the graft in microscopic tympanoplasty, as it has been reported in previous~     studies, so if there is found more integrity with this material, it can be recommended for~     routine use, improving the final prognosis of the patients.~   "
71564|NCT02120638|"~     Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge~     to TB control program. That pyrazinamide can shorten the course of treatment and facilitate~     bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide~     throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing~     has not been widely used in clinic. And the conventional testing is time-consuming and~     unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can~     provide rapid results of pyrazinamide susceptibility. The purpose of this study is to~     evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility~     in optimizing the MDR-TB treatment regimen.~   "
71565|NCT02120625|"~     The purpose of this study is to document the effectiveness of the Nimbus Multi-tined~     Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the~     small medial branch nerves that carry pain information from the facet joints. Subjects will~     be selected, by way of clinical evaluation and response to medial branch blocks, to undergo~     this procedure of radiofrequency ablation/neurotomies of the medial branches to the specific~     painful facet joints of the low back in order to relieve pain. This will be carried out with~     an FDA-approved device using a standard technique that has been accepted throughout the~     world. The difference in this study is that we will make use of MRIs to image the lesion~     that is produced and a special EMG study to look at the muscles in the back to document the~     effectiveness of the device in creating the intended lesion. No other study of this kind has~     been produced to look at this or any other radiofrequency device in the treatment of low~     back pain.~   "
71566|NCT02120612|"~     The purpose of this study is to determine the effect that an educational intervention has on~     patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a~     suburban outpatient treatment program.~   "
71567|NCT02120599|"~     Malnutrition during pregnancy is more common in poor women in the developing world due to~     inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is~     more consequential than among other demographic groups with increased risk of maternal and~     infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating~     moderate malnutrition during pregnancy remain largely undocumented. This study tests the~     hypothesis that providing either a fortified flour or fortified paste-based supplementary~     food designed to replete the nutrient deficits during pregnancy will result in improved~     maternal nutritional recovery rates and higher infant birth weights and lengths. This study~     is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately~     malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations:~     1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended~     daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a~     multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients~     (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and~     folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the~     supplementary food until they recover from MAM. The outcome of the pregnancy and maternal~     nutritional status will be followed until 3 months after delivery.~   "
71568|NCT02120586|"~     This study evaluates two strength training protocols (one in peripheral muscles and one in~     inspiratory muscles) in the improvement of skeletal muscle mass and function in~     institutionalized elderly with sarcopenia. Participants will be assigned randomly in a~     control or one of both experimental groups.~   "
71569|NCT02120573|"~     This prospective study evaluate teaching efficacy of CPR training using different methods in~     general population, medical students and non medical students with the 12 months evaluation~     of its recall~   "
71582|NCT02120404|"~     The purpose of this study is :~      - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart~     rate of 10% or 20%.~   "
71583|NCT02120391|"~     The purpose of this study is to assess an iPhone application to increase adherence to~     maintenance medications in subjects with ulcerative colitis.~   "
71584|NCT02120378|"~     Due to the discrepancy between the Egyptian and the conventional definition of miscarriage~     or live birth, there seemed to be a need for a study that ends up with reaching a definition~     for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of~     weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate~     has a chance of survival if the weight is more than 1000 grams or of gestational age more~     than 26 weeks.~   "
71585|NCT02120365|"~     The purpose of this study is to determine whether perampanel alters the response to alcohol~     for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and~     reinforcing properties of alcohol in the laboratory setting.~   "
71771|NCT02117934|"~     The purpose of the study is to evaluate the safety and immunogenicity of an investigational~     hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.~   "
71772|NCT02117921|"~     To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients~     suffering from chronic pain syndromes without organic etiology.~   "
71570|NCT02120560|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States, and~     treatment by AF ablation is quickly becoming the favored definitive therapy. Nonetheless, AF~     ablation comes with some risk, including bleeds related to vascular access and myocardial~     damage, as well as the rare incidence of clinical stroke from blood clots that travel from~     the heart to the brain, termed cerebrothromboemboli. In fact, cerebrothromboemboli without~     any symptoms have been detected by special imaging procedures called brain magnetic~     resonance imaging (MRI) in as many as 22% of cases.(1-6) There remains clinical equipoise~     amongst experts regarding balancing the risks and benefits of continued versus interrupted~     blood thinning, or anticoagulation during AF ablation as they pertain to risk of bleed and~     cerebrothromboemboli prevention, respectively, and the potentially more subtle sequelae of~     these apparently silent cerebrothromboemboli remain unknown. In fact, both interruption and~     continuation of anticoagulation during AF ablation are the standard of care. The~     investigators will perform the first randomized trial of uninterrupted versus interrupted~     anticoagulation in patients undergoing AF ablation to determine if it mitigates neurologic~     injury. The objective of this research is to investigate the effect of continued~     anticoagulation for AF ablation on cerebrothromboemboli, and the neurocognitive sequelae of~     embolic lesions, which to this point are considered subclinical. The investigators~     hypothesize that continued anticoagulation will both reduce cerebrothromboemboli and~     mitigate any potential decline in neurocognitive function post-procedurally. The~     investigators also hypothesize that the incidence of cerebrothromboemboli (CTE) by MRI will~     mediate that difference.~   "
71571|NCT02120547|"~     To determine whether CVC exposures are altered in subjects with impaired hepatic function,~     compared to subjects with normal hepatic function. The results will help guide the clinical~     use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any,~     and identify the potential need for dose adjustments of CVC in this population.~   "
71572|NCT02120534|"~     The present study will be conducted to determine the dynamic changes of serum soluble CD14~     and the corresponding changes of serum CD88 and their correlation in critically ill sepsis~     and SIRS patients.~   "
71573|NCT02120521|"~     A total of 120 patients will be included in the study. Sixty patients are critically ill~     with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill~     without evidence of infectious organism (SIRS group). At admission, Patients data include~     clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood~     gas analysis are measured. Routine cultures will be obtained. The attending physician will~     evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in~     ICU. A serum level of sTREM-1 and MNDA will be monitored.~   "
71574|NCT02120508|"~     The substantial efficacy and the possible mechanism of repetitive transcranial magnetic~     stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the~     rTMS was associated with increased synaptic connection and neural regeneration which can be~     evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS~     intervention was monitored by clinical testing and neuroimaging study.~   "
71575|NCT02120495|"~     This study will apply the digital techniques to do the condylectomy through an intraoral~     approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new~     surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and~     increase the precision of the operation procedure.~   "
71576|NCT02120482|"~     Recipient desensitization is a prerequisite for successful ABO-incompatible kidney~     transplantation (ABOi-KTX). Published desensitization protocols commonly include the use of~     plasmapheresis or selective (i.e. antigen-specific) immunoadsorption (IA), together with~     distinct immunomodulatory measures (e.g. CD20 antibody rituximab). Selective IA represents~     an efficient but cost-intensive therapy. An alternative could be the use of semi-selective~     (non-antigen-specific) IA. Even though highly efficient in depleting ABO-specific IgG,~     semi-selective IA may only marginally affect levels of ABO-specific IgM, which might - due~     to the strong complement activating potential of this Ig class - exhibit a potential risk~     for (hyper)acute antibody-mediated rejection (Wahrmann et al. 2012, Nephrol Dial~     Transplant). In a randomized crossover trial (Eskandary et al. 2014, Nephrol Dial~     Transplant; www.clinicaltrials.gov, NCT01698736) we have recently shown that the combination~     of semi-selective IA together with membrane filtration, a technique primarily used in the~     field of LDL apheresis, can yield excellent elimination of both IgM and IgG reactivities, as~     well as essential macromolecules such as the classical complement key component C1q. In this~     two-center phase 2 pilot study (N=10) we plan to evaluate the safety and efficacy of this~     alternative desensitization strategy in ABOi-KTX.~   "
71577|NCT02120469|"~     This phase I/IB trial studies the side effects and best dose of eribulin mesylate and~     everolimus in treating patients with breast cancer that does not have estrogen receptors,~     progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein~     (triple-negative) and has spread to other places in the body (metastatic). Eribulin mesylate~     and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
71578|NCT02120456|"~     Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily~     treatment for two consecutive days~      Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for~     two consecutive days compared to vehicle~   "
71579|NCT02120443|"~     A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch~     Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy~     sites.~   "
71580|NCT02120430|"~     There is an increasing need for parenting programs aimed at promoting parent-child~     interaction. A variety of interventions have been proposed. The use of audiovisual materials~     for parents has been shown to be effective but limited information is available on the~     optimal timing for its use, particularly for new parents during the first year of life of~     their children.~      Based on the hypothesis that the effectiveness of information provided to first-time parents~     in modifying their knowledge, attitudes and intentions regarding rearing practices may~     depend on when the information is delivered, we designed an open randomized controlled trial~     to compare the effectiveness of administering a video at two different times, i.e. at one~     and seven months of age of the child.~      The video addressed four specific activities related to early child development: reading~     aloud to the baby, early exposure to music, promotion of early socialization for parents and~     for children.~   "
71586|NCT02120352|"~     This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having~     an overall objective to evaluate the antiviral activity, tolerability, and safety of two~     intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30~     milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1~     infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744, GSK744~     LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting~     injectable formulation of TMC278.~      The study will consist of three parts: an Induction Period, Maintenance Period and Extension~     Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study~     and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction~     Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744~     and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible~     subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg +~     TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg +~     TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction~     Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing~     on to the Extension Period). The Extension Period will allow for a collection of longer term~     efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.~      The study will involve sufficient subjects at screening in order to ensure a total of~     approximately 265 subjects at the beginning of the Induction Period and approximately 225~     subjects randomized into the Maintenance Period.~   "
71587|NCT02120339|"~     Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV~     function in patients with PAH.~      Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH~   "
71588|NCT02120326|"~     The purpose of this study is to determine whether TDCS is an effective prophylactic therapy~     of chronic migraine.~   "
71589|NCT02120313|"~     The purpose of this study is to compare inpatient and outpatient rehabilitation following~     total knee arthroplasty. Outpatient rehabilitation should be provided at the same level of~     quality as inpatient care. Thus, it is assumed that outpatient rehabilitation is~     non-inferior to the inpatient standard-of-care therapy.~   "
71590|NCT02120300|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)~     in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir~     (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection.~     Participants with an inherited bleeding disorder and chronic HCV infection (either~     monoinfected or HIV-1/HCV coinfected) will be enrolled.~   "
71591|NCT02120287|"~     This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to~     the tumor bed border zone in conjunction with the usage of bevacizumab.~   "
71592|NCT02120274|"~     The purpose of this study is to evaluate the effectiveness of the supplementation of~     vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the~     treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease~     inhibitor in Brazil.~   "
71593|NCT02120261|"~     This study is a prospective, randomized, double-blinded trial involving adult patients~     diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to~     compare if there is a therapeutic difference between trigger point injections of normal~     saline and conventional drug mix (local anesthesic + steroid) in treating MPS. In~     particular, we will find out about the pain level and duration before and after injection.~   "
71594|NCT02120248|"~     The U.S. Surgeon General has recommended that peer counseling to support breastfeeding~     become a core service of the Supplemental Nutrition Program for Women, Infants and Children~     (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that~     offered peer counseling. Little is known as to the effectiveness of these peer counseling~     programs. Randomized controlled trials of peer counseling interventions among low-income~     women in the U.S. showed increases in breastfeeding initiation and duration, but it is~     doubtful that the level of support provided could be scaled up to service WIC clients~     nationally. The investigators tested whether a telephone peer counseling program among WIC~     participants could increase breastfeeding initiation, duration and exclusivity.~   "
71595|NCT02120235|"~     Although lysosomal storage disorders, such as Fabry disease, Gaucher disease, and Pompe~     disease, represent serious challenges in the healthcare system, no study has yet~     investigated the prevalence of these diseases in the US. Frequently, patients show~     progressive worsening of symptoms for several years before they get diagnosed. Since many of~     these diseases can be managed therapeutically, it is important to identify and treat~     patients in order to avoid organ damage. The investigators aim to undertake a screening~     study that identifies undiagnosed patients with lysosomal storage disorders and determine~     the prevalence of these diseases with special focus on underrepresented minority groups.~   "
71596|NCT02120222|"~     This phase I clinical trial studies the side effects of selinexor in treating patients with~     melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor,~     may stop the growth of tumor cells, by stopping them from dividing.~   "
71597|NCT02120209|"~     The primary objective of this study is to elaborate a new simple clinical tool for the risk~     of falls among older inpatients.~   "
71598|NCT02120196|"~     The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for~     secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis~     and ascites.~   "
71599|NCT02120183|"~     This is a study to determine the effectiveness of a Group Therapy that provides~     psycho-education and support for caregivers of cancer patients. Caregivers must be between~     21 and 64 years of age and be willing to attend a one-hour a week program for four weeks.~     The sessions will be in English, and a set of questionnaires (demographic data, some~     information about your family member with cancer, and scales: Caregiver Quality of~     Life-Cancer Scale (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale~     (HADS)) will be completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some~     participants placed on a wait-list to start the Group Therapy 4 weeks later will also~     complete the set of questionnaires at this point. A Feedback and Satisfaction Questionnaire~     will be completed at the end of the 4 week program. In addition, at the end of the 4 week~     program, some participants will go through a 15-minute interview.~   "
71600|NCT02120170|"~     There have been very limited evidence about the bleeding complication during colon~     polypectomy for the patients taking warfarin.~      This study is aimed to analyse the effect of prophylactic hemo-clipping during colon~     polypectomy for the patients with warfarin consumption.~      The enrolled subjects are the patients who take warfarin for high thromboembolism risk and~     should take heparin bridging therapy during colon polypectomy instead of temporary stopping~     warfarin. The investigators will randomize into two groups; the patient enrolled into group~     1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of~     immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping~     only for the lesion of immediate bleeding during colon polypectomy.~      The primary endpoint is to compare the rate of delayed bleeding between two groups.~   "
71601|NCT02120157|"~     We propose a multi-institutional phase II haplo-identical T cell replete BMT study in~     children with high-risk leukemias. The myeloablative conditioning regimen prescribed will be~     TBI-based for lymphoid leukemias and busulfan-based for myeloid leukemias. Our goal is to~     establish an easily exportable, inexpensive platform for haplotransplantation that has a~     safety profile equivalent to matched related and unrelated BMTs. The primary objective will~     be to estimate the incidence of 6-month non-relapse mortality, hypothesizing that NRM is <~     18%.~   "
71602|NCT02120144|"~     The aim of study is to examine the combined effect of observation and imagination of gait on~     stride time variability of stride time among in healthy young and older adults.~   "
71603|NCT02120131|"~     the purpose of this study was to test the effectiveness of the envelope flap compared to~     trapezoidal flap in impacted mandibular third molar extractions.~   "
71604|NCT02120118|"~     The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment~     failure solid tumors are tumor response rate, while secondary goals are rates of acute and~     late adverse effects, local control rate, distant metastasis rate, progression-free rate and~     overall survival rate.~   "
71605|NCT02120105|"~     The purpose of this study is to determine whether urinary cystine capacity, an assay used to~     measure the amount of cystine in the urine, can be used to predict stone recurrence in~     patients with cystinuria.~   "
71606|NCT02120092|"~     Background: Coronary heart disease is the most common cause of death in industrialized~     countries. Revascularisation by percutaneous coronary angioplasty or thrombolysis is the~     main principle for treatment of the acute coronary syndrome. To inhibit platelet activity~     patients are routinely given acetylsalicylic acid (ASA) and clopidogrel, a second-generation~     thienopyridine. Recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several~     pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk~     than clopidogrel. Coronary thrombus formation is a complex process and the antithrombotic~     mechanisms of platelet function inhibitors are incompletely understood. Studies in venous~     blood or in vitro do not truly reflect the in vivo circumstances as they often do not take~     into account flow conditions or the interaction between endothelium, blood cells and~     coagulation factors. Results from animal models may not be relevant for the prothrombotic~     mechanisms in humans. We have developed a technique that allows investigating hemostatic~     system activation directly at the site of thrombus formation in vivo in humans.~      Aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without~     concomitant ASA) on hemostatic system activation under circumstances close to the in vivo~     situation.~      Design, patients and interventions: prospective, randomized, double-blind, placebo~     controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers~     who will be randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor~     or clopidogrel + ASA.~      Outcome variables: Indicators of platelet and coagulation activation [ß-thromboglobulin and~     thromboxane B2 as well as prothrombin fragment F1+2 and D-Dimer, respectively] will be~     measured before and at several time points during a 8 day period in venous blood and in~     blood emerging from a standardized injury of the microvasculature to determine bleeding time~     (shed blood).~      Statistical considerations: Sample size calculation is based on the percent change in the~     main outcome variable β-TG in shed blood from baseline to 2 hours after treatment start.~     Statistical analysis is based on the full analysis set, including all randomized subjects~     who received at least the starting dose of the study medication and for whom blood~     collections at baseline and at 2 hours after treatment start have been performed.~   "
71607|NCT02120079|"~     Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse~     therapy, administered twice daily (to avoid adverse effects associated with long-term~     steroid use). This time frame is often too short to meaningfully resolve the inflammation~     associated with DED. DED often occurs when there is a decrease in the eye's tear production~     or if there is an increase in the evaporation of the tear film (a thin layer of tears that~     keep the eye moist). Eye irritation and inflammation (swelling) is often associated with DED~     because the surface of the eye is unable to maintain a normal level of moisture.~      This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be~     used to confirm clinical findings (which are noted by the doctor during an eye exam) and~     measure the immune response to the inflammation in the subject's cornea (the front part of~     the eyeball).~      IVCM is a non-invasive imaging technique that images the cornea at a cellular level with~     800x magnification, using a scanning laser. The laser is used to map the cornea, and will~     not damage or harm the subject's eye. Studies have shown that IVCM can be used to study~     cells and nerves within the cornea, providing a better understanding of how the cornea~     reacts to irritants. IVCM has recently been used by the investigator to assess the extent of~     eye inflammation in cases of dry eye patients.~      Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax~     and artificial tears, in treating the inflammation associated with DED by measuring changes~     in immune cells with IVCM imaging. The subject will be treated with either Lotemax~     (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an~     FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED.~     Artificial tears are approved by the FDA for treatment of dryness associated with DED.~      Thus, this study is designed to determine the effects of the administration of a topical~     steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting~     efficacy. In order to achieve the aforementioned goal, subjects will be prospectively~     randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will~     follow the same study schedule.~   "
71608|NCT02120066|"~     Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant~     tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial~     macroanuerysms.~   "
71609|NCT02120053|"~     More than 2 million French people suffer from the widespread disability of edentulism, with~     large consequences on function, nutrition, aesthetics and well-being. Complete denture is a~     common therapeutic strategy.~      The immediate complete denture technique consists in placing the denture in the same~     clinical session as last anterior teeth extractions. With this technique, aesthetic and~     function are immediately reintroduced and the patient is never left toothless or without any~     denture.~      After teeth extractions, alveolar healing process leads to ridge resorption with bone volume~     modifications and reduction in height and width.~      However ridge bone volume is an essential factor in removable denture stability. With~     implantology as an alternative prosthetic strategy, ridge volume is also a most important~     factor to place dental implants in a situation close to previous dental roots position. In~     order to preserve bone volume, a current alternative strategy proposes to place bone~     substitute materials in tooth sockets after extraction. This strategy was never evaluated~     with the immediate complete denture technique.~      Hypothesis: A new strategy associating immediate complete denture and bone substitute~     material is more effective than conventional immediate complete denture in a bone~     preservation perspective.~   "
71610|NCT02120040|"~     Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost~     complete penetrance) that predisposes to many tumors including some associated with a poorer~     outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.~      The diagnosis of VHL disease may be challenging because tumors have an asynchronous and~     multi-organ development and there is often no apparent hereditary context. As it is admitted~     that VHL disease is underdiagnosed, some countries have decided to recall patients~     presenting one of the potentially VHL disease-associated tumors to screen them for VHL~     mutation. Screening is currently recommended in guidelines but many patients may have not~     been previously screened.~      Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors~     and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population~     enables the diagnosis of other tumor types at an early stage of development since HB is~     chronologically the second tumor occurring during the VHL disease history.~      But it raises critical problems and questions: difficult announcement of a potentially~     severe disease and psychosocial dimension related to inheritance of the disease.~   "
71611|NCT02120027|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as~     compared to placebo in women with IBS-D over a 24-week treatment period.~   "
71612|NCT02120014|"~     The primary hypothesis is that patients with HFREF (heart failure with reduced ejection~     fraction) will demonstrate a markedly expanded intravascular volume which will correlate~     with elevated right heart hemodynamics and increased venous capacitance parameters, whereas~     patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate~     euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous~     compliance parameters.~   "
71613|NCT02120001|"~     The purpose of this study is to test the efficacy of a novel cleaning device in keeping~     silver-coated endotracheal tubes free from bacterial colonization.~   "
71614|NCT02119988|"~     The purpose of this study is to determine whether TIPS combined with variceal embolization~     are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.~   "
71615|NCT02119975|"~     Dysfunctioning executive functioning, including working memory (WM), is related to~     rumination. Findings show that working memory capacity (WMC) can be increased by training.~     The current study explored by means of a double-blind randomized controlled trial whether an~     adaptive WM training could reduce rumination, anxiety and depression in a sample of 98~     depressed and anxious individuals.~   "
71616|NCT02119962|"~     Burnout patients show deficient working memory functioning. Several studies showed a~     training can increase working memory capacity. In the current study we explored whether~     training working memory can reduce burnout and burnout related symptoms and increase working~     memory capacity.~   "
71617|NCT02119949|"~     Background: Substance abusers show impaired working memory (WM) functioning. Promising~     findings show training WM results in an improved working memory capacity (WMC) and a~     decrease of clinical symptoms in a range of disorders, including alcohol addiction.~      Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on~     substance use, craving, WMC, impulsivity, attention bias and psychopathology.~      Design: A randomized double-blind placebo-controlled trial with a parallel group design. The~     WM training adapted to participants' WMC whereas the placebo training consisted of~     non-adaptive easy versions of these tasks.~      Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.~      Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who~     were in treatment as usual .~      Measurements: Primary outcome measures: Substance use and craving. Secondary outcome~     measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed~     before and after 24 sessions of WM training as well as two months after the training.~   "
71618|NCT02119936|"~     Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback~     tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests~     that Heart Rate Variability Biofeedback can improve the threshold of stress management and~     improve executive functioning. Additionally HRVB has been shown to significantly reduce~     anxiety features in women suffering from perinatal depression. The investigators hypothesize~     that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy~     complications, who are at high risk for depression and anxiety.~      Participants: Expecting mothers hospitalized for pregnancy complication, who are at high~     risk for depression and anxiety.~      Procedures: The investigators plain to use a heart rate variability biofeedback tool to~     measure stress reduction in hospitalized expectant mothers. This tool will be couples with~     validated surveys and scales, high frequency heart rate variability, saliva samples, and~     qualitative interviews to quantify the reduction in stress from the HRVB tool.~   "
71619|NCT02119923|"~     Anxiety and depression are both associated with impairments in executive functions,~     including working memory (WM) which is needed to maintain and manipulate goal-relevant~     information. Due to these WM impairments anxious and depressed individuals have difficulties~     inhibiting and shifting from irrelevant (negative) information and updating goal relevant~     information. This study explored whether training WM decreases these impairments and reduces~     clinical symptoms and rumination. Eighty-four individuals diagnosed with major depression~     and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three~     times a week, during four weeks. Before, after training and at a two months follow-up~     measurement depression and anxiety symptoms, WM capacity and rumination behaviour were~     assessed. Training WM did only result in a reduction of anxiety symptoms in the depression~     group. These findings are inconsistent with promising results of individual studies showing~     training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms.~     However, our results are in line with recent meta-analyses and reviews which show that WM~     training do not lead to generalized effects and therefore, doubt the clinical relevance of~     WM training programs.~   "
71773|NCT02117908|"~     The project aims to study whether the application of a continuous positive airway pressure~     (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF)~     lung cancer under conscious sedation compared with placebo. And, assess whether CPAP~     prevents atelectasis formation and consequently reduces the potential complications of PRF~     and improves procedural success~   "
71620|NCT02119910|"~     This investigation proposes to examine the effectiveness of a technology supported treatment~     manual for pediatric feeding disorders. Children with pediatric feeding disorders display~     intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent~     appropriate nutritional intake during meals and lead to a number of negative and potentially~     life threatening medical outcomes, including chronic malnutrition, growth retardation, and~     placement of a feeding tube. To date, behavioral intervention involving extinction-based~     procedures represents the only treatment for pediatric feeding disorders supported by~     research to improve mealtime behaviors. Due to the chronic and extreme nature of food~     refusal, treatment typically requires intensive, daily intervention conducted at highly~     specialized clinics to improve feeding behaviors. The cost and duration of intervention can~     total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential~     for serious consequences associated with chronic food refusal, combined with the high cost~     of treatment, intensifies the need to identify means to disseminate effective treatment~     approaches to the broader community of healthcare providers.~      The proposed study represents the first attempt to systematically investigate the use of a~     treatment manual to address chronic food aversion through a randomized, waitlist control~     trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders~     Program. This study will involve a total of 20 participants randomly assigned to~     experimental conditions: technology supported treatment manual or waitlist control group (10~     in each group). Children assigned to the waitlist control group will receive the technology~     supported treatment manual after the specified time on the waitlist. All participants will~     receive the same behavioral protocol involving three treatment sessions per day (45 minutes~     in length), for a total of 15 sessions across five consecutive days. Data will be collected~     on feeding behaviors during each treatment session and at follow-up using trained observers~     to collect data on mealtime behaviors, including acceptance, swallowing, disruption,~     expulsion, and grams consumed. This type of data collection and treatment is standard~     practice in the feeding disorders program; however, the use of a touch screen application~     for data capture with integrated manual is novel to this project.~   "
71621|NCT02119897|"~     Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently~     affects children undergoing hematopoietic cell transplantation (HCT). As a result of~     intensive conditioning with chemotherapy with or without total body irradiation, and in the~     case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk~     for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and~     suffering, increased utilization of opioid analgesics, and the need for intravenous or total~     parenteral nutritional support. Patients universally report OM as being the worst aspect of~     the HCT experience.A novel approach has been the use of larger light-emitting diode arrays~     to treat the at risk tissues from an extraoral approach, enabling exposure of the oral,~     oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and~     requiring only minimal patient cooperation. In this research study, the investigators are~     assessing the feasibility of providing extraorally delivered low level light therapy (LLLT)~     for the prevention of OM in children undergoing myeloablative HCT.~   "
71622|NCT02119884|"~     The purpose of the study is to find patients's response to terlipressin and octreotide~     during hepatic venous pressure gradient measurement by observing portal and systemic~     hemodynamics.~   "
71623|NCT02119871|"~     To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral~     pulmonary collapse for cardiac de-airing in open left-sided heart surgery.~   "
71624|NCT02119858|"~     This clinical trial studies diffuse optical imaging with indocyanine green solution in~     imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery.~     Indocyanine green solution is a special dye that can help doctors see the lymph nodes and~     blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine~     green solution may improve the ability to detect lymph nodes and may lead to improved~     accuracy of lymph node removal.~   "
71625|NCT02119845|"~     The primary objective of this clinical study is to evaluate the preliminary safety and~     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)~     in patients requiring chronic hemodialysis.~   "
71626|NCT02119832|"~     The primary objective of this clinical study is to evaluate the preliminary safety and~     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)~     including coiling of the brachial vein during the index procedure in patients requiring~     chronic hemodialysis.~   "
71627|NCT02119819|"~     The main purpose of this study is to compare the safety and effectiveness of the study drug~     known as LY2944876 to exenatide extended-release and placebo in participants with type 2~     diabetes mellitus. All drugs will be given by an injection under the skin. Participants~     remain on stable doses of metformin, as prescribed by their personal investigator if they~     were on metformin at study entry. Participants involvement in the study is expected to last~     about 30 weeks.~   "
71628|NCT02119806|"~     In critically ill surgical patients, delirium (confusion and disorientation) is extremely~     common and is associated with longer hospital length of stay, mortality, cost, and long term~     cognitive impairment. The goal of the study is to establish whether benzodiazepines (a~     sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by~     comparing the chances of delirium in cardiac surgery patients between two groups: a group~     that receives benzodiazepines during surgery versus a group that does not receive~     benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac~     anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to~     keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for~     intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner~     preference. Findings of this study will allow all anesthesiologists to make more informed~     decisions about what level of care our patients need.~   "
71629|NCT02119793|"~     This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of~     YVOIRE® contour injected into the anteromedial malar region in subjects who have completed~     the LG-HACL014 study.~   "
71630|NCT02119780|"~     This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with~     Restylane SubQ™ injected into the anteromedial malar region.~   "
71656|NCT02119442|"~     A growing body of data, suggests that transcatheter valves are effective when implanted in~     other locations (mitral, aortic, tricuspid) and in high pressure environments. The~     investigators plan to offer transcatheter valve implantation as an alternative to high risk~     surgery in patients who require revision of a stenotic or regurgitant valve in the~     non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative~     to patients who may be considered high risk and may not be able to survive a surgical~     procedure.The use of the devices on this protocol are for medical treatment and are not part~     of a clinical trial.~   "
71657|NCT02119429|"~     The purpose of this study is to determine whether or not there is an effect of pumpkin seed~     oil supplementation, 2 grams per day, on blood pressure (systolic and diastolic) in~     premenopausal women.~   "
71774|NCT02117895|"~     This is a prospective study of left celiac plexus resection for pancreatic cancer at the~     body and tail during standard distal pancreatectomy.~   "
71631|NCT02119767|"~     The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood~     directly from coronary arteries. These arteries supply blood to muscles of the heart and can~     become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent~     research has shown that development of ' plaques' inside coronary arteries is controlled by~     chemicals (biomarkers) released into the blood from damaged areas of the artery wall. The~     LBS is designed to collect blood samples at the exact site of plaque formation. By testing~     these blood samples for biomarkers of plaque formation, it is hoped that new diagnostic~     tests and treatments for heart disease may be developed. The proposed investigation is use~     the LBS in humans to detect these biomarkers. The safety of the LBS has already been~     demonstrated in both human and animal studies. The study will enroll 70 patients with~     coronary artery disease who are undergoing routine percutaneous coronary intervention (PCI).~     PCI is a procedure used to open up a blocked coronary artery. It uses a catheter on the end~     of which is a special balloon that is inflated inside the blocked artery to open up the~     vessel and restore blood flow. A small metal spring (stent) is usually inserted to keep the~     blood vessel open. This study will test if the LBS device, when used just prior to a PCI~     procedure, can detect biomarkers released by diseased coronary arteries. The study will also~     determine if the presence of these biomarkers is linked to the long term health of the~     patient. The study will take place at Papworth Hospital, over a period of approximately 8~     months (including telephone based patient followup calls 30 days, 6 months, 1, 2 and 3 years~     after the procedure to determine patient health).~   "
71632|NCT02119754|"~     This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects~     (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA~     criteria) having full thickness (i.e., through the dermis but not involving joint capsule,~     tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and~     meet all other entry criteria to be enrolled and receive PluroGel PN.~   "
71633|NCT02119741|"~     Objective and background: The aim of this study is to evaluate the clinical outcome of using~     the hyaluronic acid gel in reconstructing inter-dental papillae at the aesthetic zones in a~     follow-up period of six months.~      Materials and Methods: 30 interdental papilla deficiencies which would meet the the~     inclusion criteria will be evaluated. After applying local anesthesia, 0.2 ml hyaluronic~     acid gel will be injected at the affected areas. This procedure will be repeated 3 times for~     the evaluated areas. Photographs will be taken before injection this material, and at 3 and~     6 months following the intervention.~   "
71634|NCT02119728|"~     This randomized phase II trial studies how well photodynamic therapy with HPPH works in~     treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses~     HPPH that becomes active when it is exposed to a certain kind of light. When the drug is~     active, cancer cells are killed. This may be effective against squamous cell carcinoma of~     the oral cavity.~   "
71635|NCT02119715|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials~     have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life,~     and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine~     the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following~     chemotherapy in patients with breast cancer.~   "
71636|NCT02119702|"~     This is a prospective cohort study designed to define the impact of HIV infection and~     antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition~     into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a~     similar sociodemographic background and age distribution will be enrolled for comparison.~   "
71637|NCT02119689|"~     The purpose of this research study is to study blood stem cells in diabetic patients and~     normal patients. We would like to better understand if these cells, called endothelial~     precursor cells (EPCs), are not working as expected in people with diabetes. We would like~     to see if the function of these cells can predict the development of diabetic retinopathy.~      Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the~     retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding~     in the retina. Even with current treatments, the quality of life for people with diabetic~     retinopathy is much reduced.~   "
71638|NCT02119676|"~     The purpose of this study is to determine if ruxolitinib, in combination with regorafenib,~     is safe and effective in the treatment of metastatic colorectal cancer.~   "
71639|NCT02119663|"~     To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine~     for the treatment of metastatic pancreatic cancer.~   "
71640|NCT02119650|"~     The purpose of this study is to determine if ruxolitinib, in combination with~     Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of~     nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.~   "
71641|NCT02119637|"~     Background:~      - Different parts of the brain are involved in feeling touch. Researchers want to study~     whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation~     feels. rTMS is a repeated magnetic pulse that interferes with brain activity. It affects a~     small part of the brain beneath the scalp. Researchers want to find out the role of sensory~     cortex in sensing different types of touch.~      Objectives:~      - To find out the role of sensory cortex, a brain area, in sensing different types of touch.~      Eligibility:~      - Healthy adults ages 18 45.~      Design:~        -  Participants will be pre-screened with a telephone interview. Then they will be~          screened with physical and psychological exams and a urine test.~        -  In Session 1, participants will have an MRI brain scan and fill out questionnaires.~        -  For MRI, a magnetic field and radio waves take pictures of the brain. Participants will~          lie on a table that slides in and out of a metal cylinder. A coil will be placed over~          their head. They will perform a task during the scan. The scanner makes loud knocking~          noises. Participants will get earplugs. They will be in the scanner for up to 60~          minutes.~        -  In Sessions 2 and 3, participants will take Breathalyzer and urine tests. Their~          perception of touch will be measured. Then rTMS will be used to stimulate their sensory~          cortex and scalp for about 20 minutes. Their perception of touch will be measured~          again.~        -  For rTMS, a wire coil is held on the scalp. A brief electrical current passes through~          the coil and creates a magnetic pulse that affects activity in the brain.~   "
71642|NCT02119624|"~     Background:~      - People who are dependent on alcohol drink even when they know something bad might happen.~     Researchers want to learn more about why they do this.~      Objectives:~      - To study brain response when a person plays a game in different threat conditions.~      Eligibility:~        -  Healthy right-handed adult heavy drinkers age 21 60~        -  Healthy right-handed adult light drinkers age 21 60~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have an EKG and psychiatric interview.~        -  Participants will have one or two clinic visits.~        -  Participants will be asked about their alcohol drinking.~        -  They will choose a snack and alcoholic beverage that they must drink in 5 minutes.~          After their breath alcohol content (BrAC) is zero, they will play a game in the MRI~          scanner.~        -  The scanner is a metal cylinder that takes pictures of the brain. Participants lie on a~          table that slides in and out of the cylinder. They will be in it for about 90 minutes,~          lying still for up to 20 minutes.~        -  During the MRI, participants will play a simple computer game to earn food or drink~          points under different threats of electric shock. Points can be exchanged for food or~          alcohol after the game. Sometimes, participants will receive a mild electric shock~          through a metal disk on the wrist. Electric shocks will only happen if the participant~          tries to earn a reward point.~        -  After the MRI, participants use their points for another drink and snack. They will~          stay at the clinic until their BrAC is low, usually within 3 hours. Participants cannot~          drive themselves home.~        -  Participants will have a follow-up phone call the next day.~   "
71643|NCT02119611|"~     Background:~      - In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest.~     It is attached to wires in parts of the brain that affect movement. DBS might help people~     with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).~      Objective:~      - To provide DBS treatment to people with some movement disorders.~      Eligibility:~      - Adults 18 years and older with PD, ET, or certain forms of dystonia.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood and urine tests and:~        -  MRI brain scan. The participant will lie on a table that slides in and out of a metal~          cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will~          get earplugs for the loud noises. During part of the MRI, a needle will guide a thin~          plastic tube into an arm vein and a dye will be injected.~        -  Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and~          legs. They record heart activity.~        -  Chest X-ray.~        -  Tests of memory, attention, concentration, thinking, and movement.~        -  Eligible participants will have DBS surgery. The surgery and hospital care afterward~          are NOT part of this protocol.~        -  Study doctors will see participants 3 4 weeks after surgery to turn on the~          neurostimulator.~        -  Participants will return every month for 3 months, then every 3 months during the first~          year, and every 6 months during the second year. Each time, participants will be~          examined and answer questions. DBS placement will be evaluated with MRI. The~          neurostimulator will be programmed. At two visits, participants will have tests of~          movements, thinking, and memory.~   "
71644|NCT02119598|"~     Research on prehospital telestroke systems is recommended by the American Stroke~     Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and~     selection of patients for specific stroke treatments~      The experience with prehospital telemedicine for assessment of stroke severity is limited.~     Prehospital telestroke is a very promising concept, facilitating specialized stroke care in~     very early stage based on integration of bidirectional audiovisual communication with point~     of care laboratory analysis, vitals and decision support software.~      The aim of this prospective study is to investigate the safety, the technical feasibility~     and the reliability of in-ambulance telemedicine using a prototype third generation~     telemedicine system (PreSSUB 3.0).~   "
71645|NCT02119585|"~     During orthotopic liver transplantation (OLT), respiratory system function may be severely~     impaired for several reasons including anaesthesia effects, hyperdynamic volume state with~     fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is~     characterised by the release of several inflammatory mediators such as cytokines and oxygen~     free radicals which may contribute to alveolar endothelial barrier dysfunction. The object~     of this study is to investigate the respiratory system mechanics impairment in its~     partitioning between lung and chest wall.~      We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall)~     occurs after reperfusion phase of liver. This impairment is associated with the systemic~     inflammatory response following liver reperfusion.~   "
71646|NCT02119572|"~     The prevalence of diabetes has been growing rapidly in developing countries causing a~     devastating economic burden and increasing demands on healthcare systems. Therefore, there~     is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer~     support models provide a potentially low-cost, flexible means that is complimentary to the~     current existing health care services. Trained peer leaders can become qualified extenders~     to a formal healthcare system, thereby, assisting with the education delivery and bolstering~     the efforts of the professional staff. To implement a culturally- specific peer support~     program and determine whether it is acceptable, cost-effective in China is important. This~     study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support~     program and to explore it's feasibility and sustainability in China~   "
71658|NCT02119416|"~     Caffeine use is on the rise in America, and one of the most popular sources is soda. Among~     youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few~     studies have examined the role of hormones in caffeine consumption within this age group.~      The purpose of the current experiment was to determine the effect of caffeine on children 8~     and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect~     of puberty on the consumption of caffeine as well as the effect that the caffeine has on the~     body (for example: heart rate, blood pressure) and cognitive function.~   "
71659|NCT02119403|"~     To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of~     up to 72% nitrous oxide and ambient air.~   "
71775|NCT02117882|"~     It is assumed that the minimally invasive lateral approach and the traditional lateral sinus~     lift procedure will result in better outcomes in terms of height of augmented bone.~      It is also assumed that the minimally invasive lateral approach will reduce surgical~     complications and patient's discomfort in comparison with a traditional lateral sinus lift~     procedure.~   "
71647|NCT02119559|"~     In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new~     cases/year. During these last years, many new chemotherapies and targeted therapies have~     been developed improving significantly the overall survival of patients notably anti-HER~     molecules. In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on~     an anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal~     Growth Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil~     (5FU):  Extreme protocol . However, no clinical or biological criteria predictive of drug~     efficacy have been reported yet. Thus, the development of such a predictive factor is an~     urgent need in HNSCC at both the clinical and pharmacy-economic level, to propose the best~     personalized treatment. One idea would be to enumerate and characterize the circulating~     tumor cells (CTC) which could give us an early evaluation of the therapeutic efficiency. In~     this context, the investigators have developed an innovative technology, the EPISPOT assay~     (patent of the University Medical Center of Montpellier), that allows the detection &~     characterization of viable CTC in the peripheral blood. The EPISPOT technology has been~     already evaluated in the breast and prostate cancer.Thus, the investigators would like for~     the first time to perform a prospective study on a cohort of patients treated following the~     Extreme protocol, with this technology, to assess the predictive value of CTC count. The~     investigators will use the CellSearch® system as the reference test.~   "
71648|NCT02119546|"~     The purposes of this study are:~        1. To investigate whether a 3-month exercise training program would improve cognitive~          function, motor performance, integrity of brain fiber tracts and cerebral blood flow;~        2. To investigate the possible neuro-anatomical and neurophysiological mechanisms of~          exercise training on cognitive function, motor performance, integrity of brain fiber~          tract and cerebral blood flow in patients with mild cognitive impairment and in those~          with early Alzheimer's disease;~        3. To investigate the influence of different apolipoprotein E (APOE) genotypes on the~          above-mentioned exercise effects.~      The results of this study will provide medical evidence for the effects of exercise training~     on mild cognitive impairment and on early Alzheimer's disease; and will provide~     understanding of the mechanisms mediating these effects. More importantly, the results serve~     as the basis for future larger-scale exercise clinical trials for these two patient~     populations.~   "
71649|NCT02119533|"~     Mild brain injury or concussion affects about four million Americans each year. Some people~     recover completely while others, especially those with multiple concussions, develop chronic~     headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that~     concussion is difficult to treat is that it is difficult to detect. Radiographic studies~     such as CT (computed tomography scan) are by definition unrevealing of structural injury in~     concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts~     in the diagnosis of concussion but even these are not consistently present in all patients~     with symptoms. Clinical tests for concussion often require baseline studies, and thus are~     generally reserved for athletes and others at highest risk for concussion.~      The investigators have developed a novel eye movement tracking algorithm performed while~     subjects watch television or a music video that determines whether the eyes are moving~     together (conjugate) or are subtly not together (disconjugate). The investigators~     preliminary data shows that people with lesions in their brain or recovering from brain~     injury have disconjugate gaze that is not detectable by ophthalmologic examination but is~     detected by our algorithm.~   "
71650|NCT02119520|"~     Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with~     open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis~     subjects.~   "
71651|NCT02119507|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early approximal carious lesions compared to no treatment.~   "
71652|NCT02119494|"~     The purpose of this study is to assess the representation of COPD patients in terms of~     categories and phenotypes of the disease in selected countries in Central and Eastern Europe~     (CEE). The results of The POPE study will allow for evaluation of the differences in~     clinical approaches and treatment practices. The following countries are represented in The~     POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia,~     Slovenia, Estonia, Latvia and Bulgaria.~   "
71653|NCT02119481|"~     The primary aim of this study is to examine the effects of a mindfulness-based stress~     reduction training program, delivered in individual web-based sessions, among breast cancer~     patients. The objectives are to study and answer questions regarding effects of the such~     training in a randomized controlled trial including the following outcome measures: physical~     and mental health status, perceived stress, post-traumatic stress symptoms, psychological~     well-being, and sleep quality. In addition to the primary aim, the investigators plan to~     explore potential mechanisms through which mindfulness training lead to improvement in~     perceived stress, well-being and sleep-quality. This will be studied by mediational~     analyses.~   "
71654|NCT02119468|"~     This phase I/II trial studies the side effects and best dose of ixazomib and to see how well~     it works when given together with pomalidomide and dexamethasone in treating patients with~     relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by~     interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide~     and dexamethasone can modify and regulate the immune system and may stop cancer cells from~     growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment~     for relapsed or relapsed/refractory multiple myeloma.~   "
71655|NCT02119455|"~     Currently, orthodontic treatment typically lasts approximately 2 years. There are a number~     of advantages for reducing the duration of treatment, including reducing the potential risk~     of caries, root resorption and for minimizing patient burn out from prolonged treatment.~      While some evidence does exist that vibration may accelerate the speed of tooth movement,~     the biological mechanism is still unknown. Identification of specific factors involved in~     tooth movement that are further stimulated by vibration would help to understand the~     mechanisms involved as well as discover possible biologic targets which could be utilized or~     modified to maximize the benefits of vibration treatment.~      The purpose of this study is to identify novel biological factors that are expressed in~     patients undergoing orthodontic tooth movement in conjunction with vibration appliance~     therapy.~   "
71660|NCT02119390|"~     Although effective treatments are currently available to treat human immunodeficiency virus~     (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict~     adherence to the treatment regimen is required. Nonadherence to highly active antiretroviral~     therapy (HAART) regimens is well documented in individuals with HIV. This is especially true~     for adolescents and young adults (AYA), where rates of adherence range from 20 to 100%.~     Nonadherence has significant implications for subsequent treatment response and health~     outcomes, including poor virologic response, development of drug resistance, and mortality.~     Of note, previous research has suggested that every 1% increase in nonadherence is related~     to a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally~     acquired HIV. Furthermore, higher VL is the most salient variable related to increased risk~     of virus transmission. Thus, nonadherence to HAART is a significant public health issue.~      The objective of the proposed research plan is to systematically examine an individualized,~     behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current~     intervention will support AYA participation in brief, staff-delivered instruction in~     adherence-promotion skills. Individualized behavioral analysis and motivational interviewing~     will be applied to provide effective solutions for current barriers to HAART adherence~     before and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines~     for Adults and Adolescents.~   "
71661|NCT02119377|"~     This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years~     and older living in Australia. This population has received limited attention from public~     health researchers, planners, and practitioners. However, a growing body of evidence~     suggests that trans people experience disparities in several important areas of health~     compared with the population generally. In particular, trans people are more likely to~     experience mental health problems (notably depression and anxiety disorders), use alcohol,~     tobacco, and illicit drugs, and think about or attempt suicide. Additionally, trans people~     commonly report that their physical and mental health needs are not met, and underutilise~     preventive health care.~      Participants were recruited using several non-probability sampling techniques, (including~     purposive sampling and snowball sampling), because random sampling is not possible with this~     population. Medical, social, support, and advocacy networks used by trans people were used~     to promote the study. A mixed quantitative and qualitative methodology was used. Validated~     quantitative instruments were used to obtain measures of health and well-being, which will~     be compared against population norms. Qualitative items complement these measures, providing~     rich experiential data.~      The investigators hypothesised that:~        -  the prevalence of depressive and anxiety disorders will be higher than for the~          population generally, and that these conditions will commonly be undiagnosed and~          untreated;~        -  depressive and anxiety disorders will be associated with risky behaviours, such as~          tobacco, alcohol, and illicit drug use; and,~        -  trans people will report poor relationships with medical practitioners.~      The investigators hypothesised that poor mental health is a consequence of several~     interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing~     medical treatment to alter sexual characteristics); societal discrimination and stigma~     (including harassment and violence); institutionalised discrimination (including difficulty~     changing identifying documents, and exclusion of surgical procedures and related treatments~     from public and private health systems); social isolation; and the belief held by many~     clinicians that transsexualism is a mental disorder (which may be a barrier to trans people~     forming trusting relationships with medical practitioners).~   "
71662|NCT02119364|"~     Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live~     born), and is frequently accompanied by cognitive impairments and behavioural problems. The~     present study is a controlled clinical trial, a multicenter-study involving three health~     regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary~     research goal will be to evaluate the effects of computer-based cognitive training in~     children with CP. In addition, this study will be the first to conduct a comprehensive~     neuropsychological examination to improve our understanding of cognitive impairments as well~     as cognitive resources in CP children in Norway to aid in intervention planning.~   "
71663|NCT02119351|"~     The objective of this post-market, prospective study is to evaluate the clinical~     acceptability, blood leakage, risk for blood exposure, need for digital compression,~     insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to~     standard hospital PIVCs currently being used.~   "
71664|NCT02119338|"~     The investigators propose a single-center, non-randomized, single-arm study at the Barrow~     Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent~     glioma study will correlate presence of fluorescence in tumor tissue with pathological~     findings. This will be done using three cohorts in dose escalation. The investigators'~     hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result~     in less false positive fluorescence.~   "
71665|NCT02119325|"~     The primary aim of this study is to evaluate the effect of a fibre rich health food drink on~     the post prandial glucose and triglyceride peak in healthy overweight adults with impaired~     fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments,~     two period cross over study.~   "
71666|NCT02119312|"~     The purpose of this study is to identify and screen potential subjects for preliminary~     eligibility to participate in a malaria related clinical trial conducted at the Seattle~     Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.~   "
71667|NCT02119286|"~     After screening, subjects will enter a 4 week open-label run-in period with fluticasone~     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler~     (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium~     bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered~     once daily via a DPI; OR matching placebo administered once daily via a DPI), while~     continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period.~     There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening~     (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6)~     and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the~     last clinic visit. The total duration of subject participation in the study from Screening~     to Follow-up will be approximately 17 weeks.~   "
71668|NCT02119273|"~     Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with~     and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence~     supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is~     limited evidence to support their utility for CRSsNP. The investigators intend to perform a~     randomized, double blind, placebo controlled clinical trial to investigate the impact of~     steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present~     to the investigators office will be included if they have failed maximal medical management~     and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The~     investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will~     improve subjective and objective outcome measures.~   "
71669|NCT02119260|"~     This study is the first administration of GSK2798745 in humans. This will be a sponsor~     un-blinded, placebo-controlled study to investigate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2798745, given as single and repeat~     oral doses to healthy subjects and stable heart failure (HF) subjects. Approximately 28~     healthy subjects will be enrolled in the study cohorts (Cohort 1-3) involving single and~     repeat dose escalations of GSK2798745, while up to 24 stable heart failure subjects will be~     enrolled in Cohort 4 involving single and repeat dose administration of GSK2798745, with the~     dose selected based on data from healthy subject cohorts. This would be followed by~     enrollment of up to 8 subjects with heart failure in Cohort 5 involving repeat dose~     administration of GSK2798745. The study duration, including screening and follow-up, is not~     expected to exceed 17 weeks for subjects in the study (in any cohort).~   "
71670|NCT02119247|"~     The purpose of this study is to compare the systemic availability to CHF 6001 after a single~     dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose~     capsule inhaler Aerolizer®.~      CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary~     disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an~     inhaler device. Previous studies were conducted using a single-dose capsule inhaler~     (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler®~     device will be used.~   "
71671|NCT02119234|"~     The study is performed to investigate the effect of the spacing device on the~     pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without~     Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients.~     Moreover, the general safety and tolerability of the treatments will be evaluated.~   "
71672|NCT02119221|"~     The study aims to provide understanding of the relative relevance of the different excretion~     pathways of Copanlisib in humans, as well as to characterize its metabolite profile.~   "
71673|NCT02119208|"~     1. In natural environment, the moderate-intensity break will allow a reduction of the~          caloric intake at the dinner more important than for the light-intensity break~        2. In natural environment, the break taken juste before dinner will allow a reduction of~          the caloric intake at the diner more important than earlier in the day.~   "
71674|NCT02119195|"~     A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%)~     and males (35%) with 80 composite restorations were recruited at the Operative Dentistry~     Clinic at the Dental School of the University of Chile. All participants presented with~     marginal adaptation clinical features that deviated from the ideal and were rated Bravo~     according to the modified United States Public Health Service (USPHS) criteria for the~     sealing group and no treatment group. As a positive control were considered composites with~     alpha values in marginal adaptation. The protocol was approved by the Institutional Research~     Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All~     of the patients signed informed-consent forms and completed registration form. The selection~     criteria are summarized below.~   "
71675|NCT02119182|"~     The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury~     (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging,~     cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI~     from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for~     clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial~     design.~   "
71676|NCT02119169|"~     The effectiveness of pigtail catheter as a less invasive option for pleural drainage in~     patients with resistant hepatic hydrothorax.~   "
71677|NCT02119156|"~     This study will assess the effect of a 24-week withdrawal followed by a 28-week~     reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with~     stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be~     assessed for subjects who have permanently withdrawn from further belimumab treatment.~   "
71678|NCT02119143|"~     This study investigates the effects of a dietary supplement - a cocktail of vitamins and~     minerals - on the incidence of common cold in a cohort of middle management employees.The~     primary outcome is defined as the number of duty days lost due to common cold/flu. Further,~     immune parameters and markers of redox biology/oxidative stress will be determined. The~     wellbeing in the cohort will be evaluated via questionnaires.~   "
71679|NCT02119130|"~     The purpose of this study is to use a cluster randomized trial to compare the effectiveness~     of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine~     use of the tuberculin skin test (TST), the current standard of care for diagnosing latent~     tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT~     clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher~     proportion of patients and in a significantly faster timeframe. The cost-effectiveness of~     linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the~     process of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood~     draw will be evaluated using a mixed method approach to identify steps that can be modified~     for future scale-up of the intervention.~   "
71680|NCT02119117|"~     Pregnancy rates for women over 35 years old are significantly lower when compared to younger~     women. One of the causes for this decrease is believed to be chromosomal aneuploidy.~     Chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been~     implicated in spontaneous miscarriages, and preimplantation embryo wastage (Hassold and~     Hunt, 2001).~      As maternal age increases, so too does the incidence of chromosomal aneuploidy. Embryo~     quality from older patients undergoing IVF tends to be reduced and associated with higher~     rates of chromosomal abnormalities when compared to good quality embryos (Munne et al.,~     1995).~      Chromosomal aneuploidy derives from the improper segregation of chromosomes during~     preimplantation development. The process of segregation, or mitosis, includes synthesis of~     the complete genome, equal division of chromosomes to opposite poles by the spindle~     apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally~     identical cells. The entire process of cellular and genetic replication requires energy in~     the form of adenosine tri phosphate (ATP). ATP is mainly produced in mitochondria in the~     process known as the electron transport chain (ETC). There are many important molecules~     required for ATP production, CoQ10 can act as the appropriate carrier of electrons through~     the ETC. When a deficiency in CoQ10 is present, ATP production is decreased resulting in~     aneuploidy (Bentov et al., 2013). Similarly, research has shown that chromosome alignment~     and spindle formation are affected by mtDNA copy number (Ge et al., 2012). It has also been~     shown that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women~     with repeated embryonic failure has result in children with subsequent mitochondrial~     heteroplasmy (Cohen et al., 1998).~      CoQ10 concentrations have been shown to decrease as age increases (Bentov et al., 2011).~     Consequently, the decrease in CoQ10 concentrations seen in older women may cause an increase~     in chromosomal aneuploidy in subsequent embryos (Bentov et al., 2013). In this pilot study,~     we test the hypothesis that the supplementation of CoQ10 prior to an IVF cycle can increase~     mitochondrial DNA activity and possibly decrease chromosomal aneuploidy in AMA patients.~   "
71683|NCT02119078|"~     The purpose of this investigation is to assess the effectiveness of a multi-disciplinary~     Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older~     admitted to Oregon Health & Science University's hospital medicine service. The ACE program~     will aim to improve the quality of care of older patients in the investigators hospital by~     implementing focused interventions and recommendations specific to geriatric needs and~     syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early~     recognition and treatment of impaired mobility and function, careful minimization of~     medication use, prevention of unnecessary catheter and restraint use, decreased hospital~     readmission rates, improved transitional care following hospital discharge, and high levels~     of patient and referring physician satisfaction. Additionally, the ACE program aims to~     improve resident and student competence in treating geriatric syndromes, and to improve~     staff and learner satisfaction with caring for older adults. ACE programs have been well~     studied at other institutions, so the investigators will be implementing a program that is~     already standard of care, and studying the elements that are unique to OHSU.~      This will be a quality improvement project. Study participants will be a convenience sample~     of OHSU faculty, staff, residents and students who are employed by or on rotation with~     General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE~     team members) will receive the ACE training. Study personnel will conduct prospective and~     retrospective chart review of patients admitted to the ACE service to determine outcomes as~     noted above.~   "
71684|NCT02119065|"~     This pilot clinical trial studies positron emission tomography (PET)/computed tomography~     (CT) in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or~     cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging~     procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are~     present in the lung and compare the results with the pre-therapy imaging.~   "
71685|NCT02119052|"~     Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a~     variety of extrarenal manifestations of which polycystic liver disease is most common. The~     investigators aimed to assess the changes over time of liver volume in ADPKD patients and~     whether it is affected by the treatment with the somatostatin analogue, octreotide.~      35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment~     with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic~     resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.~   "
71686|NCT02119039|"~     CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents).~     It consists of large biopolymers, imitating the structure of heparansulphate. The protecting~     effect on different biological tissues and enhancement of wound healing has been described~     in several studies.~      Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per~     100,000 per year across different populations. Corneal collagen cross-linking represents a~     treatment option for these patients, aiming to prevent progression of the disease via~     stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet~     A/riboflavin cross-linking procedure significantly improves the outcome of the intervention,~     due to ameliorated distribution of riboflavin.~      The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial~     wound closure after collagen cross-linking in patients with keratoconus. Results may lead to~     an improved management and pain reduction of patients with corneal epithelial defects.~   "
71687|NCT02119026|"~     Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for~     metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®)~     proved equivalence to 5-FU and is a well tolerated alternative combination partner for~     Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of~     mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor~     of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody~     bevacizumab (Avastin®).~      XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an~     approach with clearly defined cross-wise XELIRI-XELOX change criteria. This trial~     investigates two different sequential treatment options with XELIRI/ XELOX in first and~     second line with the addition of bevacizumab and tries to give answer to the question if~     there is an optimal sequence for the benefit of the patient.~      This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who~     did not receive systemic treatment for their metastatic disease. The study is designed to~     evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab~     in terms of Duration of Disease Control (DDC).~      Patients will be treated with an established first line therapy consisting of either XELOX~     or XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior~     disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given~     until disease progression, unacceptable toxicity or patient refusal.~      Capecitabine can be given in addition at the investigators' discretion until disease~     progression, unacceptable toxicity or patient refusal.~      If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan~     should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation~     Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be~     discontinued in first line treatment bevacizumab should be continued. In case of permanent~     discontinuation of bevacizumab for toxicities, chemotherapy should be continued.~      Upon completion of first line chemotherapy patients with disease control will receive~     bevacizumab maintenance treatment. On investigators decision patients can receive~     Capecitabine as additional maintenance treatment.~      The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab~     followed by XELOX + bevacizumab scheme at progression in comparison with the reverse~     sequence based on DDC.~      Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall~     response rate, time to response, duration of response, overall survival, tumor assessments~     (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical~     examination.~   "
71688|NCT02119013|"~     Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset~     hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with~     LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic~     function in ADPKD patients and whether they were affected by the treatment with the~     somatostatin analogue, octreotide.~      35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26~     mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or~     octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and~     study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux~     formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and~     pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by~     tissue Doppler imaging.~   "
71743|NCT02118298|"~     The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory~     when compared to more established measures of cognition in identifying cognitive~     difficulties among MS subjects when compared to controls. 2. Determine which cognitive test~     variable will be most strongly associated with self and informant reports of cognition. 3.~     Determine which MRI metric will be most strongly related to neuropsychological test~     performance 4. Determine the degree to which allocentric visual memory is related to~     functional connectivity on fMRI.~   "
71689|NCT02119000|"~     Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment~     of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure,~     and is associated with decreased lesional detection rates. The ideal bowel preparation~     formulation should be able to completely clean the bowel, without leaving solid or liquid~     residues, and without modifying the mucosal appearance.~      Bowel preparation may be administered in hospitalised patients or in the ER. Patients have~     less control on their environment and the intake of the bowel preparation. For example,~     there may be a delay in pharmacy delivery or inadequate supervision by the treating~     personnel. Hospitalised patients have more comorbidities, are usually less autonomous and~     mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple~     studies have identified hospitalization status as an independent risk factor for poor bowel~     preparation.~      The objective of this study is to access which bowel preparation regimen, between PEG 3350~     with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG~     3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the~     cleanest bowel preparation in hospitalised patients.~   "
71690|NCT02118987|"~     This research study is evaluating a drug called omalizumab (brand name 'Xolair') as a~     potential treatment to be used in conjunction with drug desensitization to prevent reactions~     from recurring and allowing the participant to be treated with the chemotherapy the~     participant's oncologist prefers to give.~   "
71691|NCT02118974|"~     Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic~     surgery with little direct evidence that it is if not better than traditional laparoscopic~     surgery, at least equivalent. We designed a randomized-controlled trial to compare operative~     times, length of hospital stay, estimated blood loss, and post-operative complications~     associated with these two methods of minimally invasive hysterectomy.~   "
71692|NCT02118961|"~     This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a~     booster dose in adolescents.~      The purposes of this study are as follows:~        -  To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid~          (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and~          anti-tetanus toxoid (anti-T) antibodies~        -  To confirm that booster responses for anti-pertussis toxoid (anti-PT) and~          anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants~          received BK1301~   "
71693|NCT02118948|"~     The purpose of this study is to develop and evaluate an HIV risk reduction intervention for~     women with a history of abuse.~   "
71694|NCT02118935|"~     The study is intended to measure infant comfort, behavior, and sleep when consuming study~     formula with prebiotics compared to infants who consume a study formula without the~     prebiotics.~   "
71695|NCT02118922|"~     We have developed novel Brillouin microscopy and we are testing its potential for~     keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human~     volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas~     and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.~   "
71696|NCT02118909|"~     This study is designed as a 2-part, open-label study to assess the effect of pracinostat~     with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the~     bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of~     pracinostat administered with itraconazole or ciprofloxacin.~   "
71697|NCT02118896|"~     The purpose of this study was to offer patients who had participated in one of the phase II~     PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until~     commercial availability of the drug and to record long term efficacy and safety data.~   "
71698|NCT02118883|"~     The purpose of this study is to examine and compare the rehydration effect of Essentia~     Water, an electrolyzed high-pH bottled water, with industry-standard bottled water purified~     by reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality,~     (3) bioelectrical impedance analysis, and (4) body mass change, using serial measurements in~     apparently healthy adults following exercise-induced dehydration in a controlled~     environment.~   "
71699|NCT02118870|"~     Background:~      The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still~     under debate. This is especially true for STEMI patients in the era of new anticoagulants~     and antiplatelet agents. Yet, the potential benefits of longterm dual antiplatelet therapy~     in avoiding thrombotic complications may be clearly counterbalanced by a higher risk of~     major bleeding complications. In particular, the COMBO dual therapy stent, being associated~     with early re-endothelization, may allow for a reduction of the duration of DAPT (dual anti~     plateled therapy) without increasing the thrombotic risk, while reducing the risk of severe~     bleeding complications.~      Study Objective:~      Aim of the current study is to demonstrate a non-inferiority of a strategy of short-term~     DAPT (90 days) as compared to standard 360 days DAPT in ACS patients treated with Combo~     stent.~      Study Design:~      This study is a prospective, multicenter, randomized, investigator-initiated study designed~     to enroll 1500 patients with ACS receiving a COMBO dual-therapy stent who will be randomized~     1:1 to either short term (90 days) or to standard (360 days) DAPT. Patients will be~     randomized within hospitalization (before discharge in case additional revascularization is~     deemed necessary and performed during hospitalization). Clinical visit is scheduled at 90,~     and 360 days, whereas a telephone contact will be performed at 180 and 720 days.~      Patient Population:~      The study population will consist of up to 1500 ACS patients (male and female) older than 18~     years amenable to percutaneous treatment and treated with a COMBO stent. Subjects must meet~     all of the eligibility criteria and provide written informed consent.~   "
71700|NCT02118857|"~     The human body houses a huge microbial ecosystem, including the intestinal and oral~     microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible~     for maintaining human health. The response of the organism to the diet and the relative~     alteration of the susceptibility to disease are worth of investigation to comprehend the~     role of the microbiota to maintain the state of well being in humans. This concept, which is~     the overall scientific basis of the entire project, perfectly fits with the declared scopes~     of Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human~     intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme,~     which is addressing the human nutritional needs and the impact of food on human~     physiological functions. In particular, studying the link between dietary habits and the~     intestinal microbiota activity will be pivotal to improve the food-based promotion of health~     and well being. The project aims at studying how the omnivore, vegetarian and vegan diets~     may affect the oral intake of microorganims, and the composition of the oral and fecal~     microbiota. With the aim to build up a permanent European platform for such type of studies,~     ten Research Units (RUs) are involved in the proposal, with the partnership of 16 National~     and, especially, foreign Institutions, covering 12 different countries. About 50 omnivore,~     vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers~     will be asked to fill in diaries, describing their dietary habits, and to collect biological~     samples (saliva, feces and urine), once a week for three weeks. For obvious ethical~     constraints, biopsies will be not available in this study. RUs will share their tasks,~     mainly depending on the nature of the samples to be studied, namely foods and biological~     samples. Based on the different dietary habits, the presumptive intake of microorganims will~     be estimated using literature data and, especially, culture-dependent methods. Typing and~     antibiotic resistance of some food related microbial communities or foods will be also~     investigated. The microbial diversity of foods, whose microbiota has never been studied in~     depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome~     characterization will complete the overview on foods. After collecting and preparing~     biological samples from the three diet groups, the oral and fecal microbiota will be~     studied. The viable cell number of several microbial groups will be estimated in fecal~     samples, before freezing. Preliminarily, the microbial diversity of saliva and fecal~     ecosystems will be analyzed through PCR-DGGE. PCR assessment of genetic basis of antibiotic~     resistance will be also carried out. Selected numbers of biological samples will be further~     subjected to next generation sequencing, aiming at determining representative~     individuals/samples of the three types of diet. Only for feces, representative samples~     (e.g., 4/5 for each diet) will be subjected to meta-omics analyses based on meta-genomic,~     meta-transcriptomic and meta-proteomic approaches. An integrated and iterative workflow will~     be also developed, by assembling an in house synthetic meta-genome. The functionality of~     fecal samples and/or of isolates from feces will be characterized based on fecal genotoxic~     and anti-genotoxic activities, and modulation of the immune response. In agreement with an~     holistic approach, the metabolome analysis of saliva, feces and urine will complete the~     characterization of biological samples. All data available from the different RUs will merge~     into a common database, whose structure will be developed during the project. Based on the~     literature data (ISI Web of Knowledge), this is the first study that aims at correlating the~     effect of the main dietary habits on the oral and fecal microbiota through integrated~     meta-omics analyses.~   "
71701|NCT02118844|"~     The purpose of this study is to determine whether deep neuromuscular blockade compared to~     moderate neuromuscular blockade may improve the surgical conditions in patients undergoing~     laparoscopic bariatric surgery.~   "
71702|NCT02118831|"~     Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the~     systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on~     circulating vascular endothelial growth factor. In the present prospective study, the~     investigators evaluated serum drug levels and plasma free vascular endothelial growth factor~     (VEGF) levels in patients with neovascular age-related macular degeneration following~     intravitreal injections of ranibizumab, bevacizumab and aflibercept.~   "
71703|NCT02118818|"~     Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral~     immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The~     most serious complication is rheumatic heart disease (RHD), one of the most common problems~     facing children and young adults worldwide, which leads to chronic valvular lesions. It is~     estimated that 60% of all acute rheumatic fever cases will develop RHD.~      The pathogenesis of RHD is complex with both environmental and genetic factors contributing~     to its etiology. The investigators know little about the genetic etiology, cellular events~     and modifiers of progression of RHD, and there exists a wide range of disease severity and~     progression to severe valve pathology.~      Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high~     incidence of RHD, using a combination of next-generation targeted exome capture,~     transcriptomics, and expressed quantitative trait loci (eQTL) analysis.~   "
71704|NCT02118805|"~     This study is evaluating the use of two painless, non-invasive technologies in the~     assessment of muscle health over time in both healthy volunteers and patients who have~     diseases that affect the nervous system.~   "
71705|NCT02118792|"~     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical~     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic~     dermatitis.~   "
71706|NCT02118779|"~     Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as~     an autosomal dominant multisystemic disorder. It is the most common adult form of muscular~     dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733~     million people in Europe, we estimate that 75,000 people are DM1 patients in Europe.~      The aim of OPTIMISTIC is to improve clinical practice in the management of patients with~     this rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a~     multi-centre, randomised controlled trial designed to compare a two component tailored~     behavioural change intervention to increase physical activity against standard patient~     management regimes, with particular attention given to the definition of appropriate outcome~     measures and new clinical guidelines for DM1 management. The two components of the~     intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and~     we will evaluate the intervention's effectiveness and safety against standard patient~     management.~      Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in~     France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18~     years and older with genetically proven classical or adult DM1 suffering from severe fatigue~     (only DM1 patients with a CIS subscale fatigue score > 35 are likely to benefit from the~     intervention), able to walk independently and able to complete the trial interventions will~     be included.~      A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the~     patients and have a rate of change that is appropriate for a clinical trial timeframe. In~     addition, OPTIMISTIC will identify genetic factors that predict outcome and potential~     biomarkers as surrogate outcome measures that best explain the observed clinical variation.~   "
71707|NCT02118766|"~     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical~     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic~     dermatitis.~   "
71708|NCT02118753|"~     In the laboratory, the researchers will investigate whether the drug eplerenone improves~     contractile function after ischemia and reperfusion in heart tissue.~   "
71709|NCT02118740|"~     This is a observational study in which healthy found volunteers are recruited to donate 50~     ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and~     safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL~     is only for animal studies and after completion of the preclinical program, the intention of~     AMARCELL is to treat humans with a traumatic Spinal cord injury.~   "
71710|NCT02118727|"~     The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction~     with riluzole, can slow down the disease progression of patients with ALS including~     potentially improving their neuropsychiatric changes, as well as determine if CSF protein~     biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS.~      Funding Source-FDA OOPD~   "
71711|NCT02118714|"~     This study is being conducted to evaluate the effects of Atrasentan on sperm production and~     the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy.~   "
71712|NCT02118701|"~     Shared Decision Making (SDM) is defined as a process where healthcare professionals and~     patients make decisions together, using the best available evidence. SDM, as a communication~     and decision method, can be used also with persons suffering from dementia. Yet, SDM with~     persons with dementia or even with their family caregivers is not widespread.~      The present research project aims to develop and evaluate an SDM framework in care planning~     to be implemented in long-term care facilities, in order to obtain a constantly developing~     care plan that focuses not only on the medical, physical, psychosocial and spiritual needs~     of the resident, but that considers and documents his preferences and the actions taken by~     caregivers to meet them.~      The current project is a controlled exploratory study. Case studies that involve a triad in~     each case, composed by the resident with moderate or severe dementia, his family caregiver~     and the professional usually taking care for the resident, will be used (n=16 professionals;~     n=40 residents; n=40 family caregivers). Professional caregivers of two nursing homes, one~     located in Italy and one in the Netherlands, will receive a specific training in SDM~     principles and will guide the SDM interview within the triad. Primary outcome will be the~     proportion of residents whose preferences and needs, together with the related actions to~     meet them, are known, documented and satisfied in their 'life-and-care plans'. Secondary~     outcomes are the residents' and family caregivers' quality of life; the family caregivers'~     sense of competence and the healthcare professionals' job satisfaction. Semi-structured~     interviews and focus group interviews will be performed to assess satisfaction with the~     intervention and barriers and facilitators to its implementation. Assessments are performed~     at baseline and six months after the intervention.~      We hypothesize that the use of the SDM process in care planning will increase the number of~     met needs and will improve the residents' and family caregivers quality of life, the family~     caregivers' sense of competence and the healthcare professionals' job satisfaction.~      The key element of this study is that it will contribute to our knowledge about the efficacy~     and feasibility of an SDM framework in care planning in long-term care facilities with~     persons with moderate to severe dementia.~   "
71713|NCT02118688|"~     The purpose of this randomized clinical trial is to determine whether risperidone alone,~     trazodone alone, or a combination of risperidone and trazodone is superior for the treatment~     of ICU acquired delirium. The hypothesis is that combination therapy is superior to either~     agent alone in treating ICU acquired delirium and sustaining delirium free time.~   "
71714|NCT02118675|"~     The study is to collect the body composition data using five different methods-bioimpedance~     analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical), deuterium dilution (heavy~     water), body circumferences (tape measure, TC2), and tissue thickness by ultrasound (GE~     Medical, BodyMetrix).~   "
71715|NCT02118662|"~     The study is designed to measure the energy expenditure associated with a common office task~     (i.e., typing) while 1.) seated in an office chair, 2.) pedaling using a prototype pedal~     desk, and 3.) walking on a treadmill.~   "
71716|NCT02118649|"~     Participants will play a computer game that is controlled by their gaze patterns and~     designed to direct attention their attention to specific on-screen targets. Visual attention~     to targets will be rewarded. Both visual behavior and brain response will be recorded during~     game play.~      It is hypothesized that that, over the course of the game, relative to baseline,~     participants will show (a) increased looking to targets, (b) decreased response time to~     targets, and (c) enhanced, more efficient neural response to visual cues. It is hypothesized~     that clinical variability will associate with visual attention and brain response.~   "
71717|NCT02118636|"~     Early stage hormone receptor positive breast cancer is typically treated with adjuvant~     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve~     overall survival from the disease. Typical agents used for treatment include tamoxifen and~     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is~     increasingly common because it is associated with fewer long-term serious toxicities~     compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of~     patients, which can influence adherence to therapy and can lead to treatment discontinuation~     in a minority of cases. The mechanism underlying development of this toxicity remains~     unclear, and predictors of who will develop these symptoms remain undefined. This~     observational study is designed to collect patient-reported outcomes and serial serum~     samples in order to investigate potential etiologies of this bothersome toxicity.~   "
71718|NCT02118623|"~     This study will examine if there is a benefit of an online intervention for persons with~     bipolar diagnoses, and what components appear to be most useful.~   "
71719|NCT02118610|"~     Schizophrenia is a devastating and complex illness, with multiple symptom and behavioral~     manifestations. Antipsychotic medications are the mainstay of treatment; however, many~     patients only partially respond to treatment. Development of new treatment has not~     progressed rapidly, in part, because the underlying etiopathophysiology of the illness is~     not well understood. To date, all pharmacological treatments approved for use in~     schizophrenia involve primary modulation of the dopamine system. Many agents without~     dopamine action have failed to demonstrate efficacy. There is growing evidence that~     schizophrenia may be, in part, due to an inflammatory process and pharmacological treatment~     approaches that decrease inflammation have shown promise. Thus, treatments that may have~     anti-inflammatory properties (e.g., TNF-alpha inhibition), but also possess dopamine~     modulation may prove to be beneficial. This novel medication, l-tetrahydropalmatine (l-THP),~     has robust anti-inflammatory properties, particularly TNF-alpha and ICAM inhibition; has~     antiprotozoal activity; and possesses an antipsychotic-like pharmacological profile of D1,~     D2 and D3 receptor antagonism. The high affinity of l-THP for D1 versus D2 receptors~     distinguishes it from first generation antipsychotics and its D1 to D2 ratio resembles that~     of the superior antipsychotic, clozapine. Also, an almost identical compound,~     l-stepholindine (l-SPD), demonstrates robust antipsychotic activity in humans (both positive~     and negative symptoms) and is currently used clinically in China. l-THP has been used for~     over 40 years clinically in China, has a good safety profile to date, and represents a novel~     and exciting mechanism for schizophrenia treatment. Initial safety data from our phase I~     study of l-THP (20 healthy controls) shows excellent tolerability and lack of any~     substantial side effects. L-THP has been tested in outpatient drug abuse trials for 4 weeks~     with good safety data, (Hu et al 2006, Yang et al 2003). Yang et al (2003) randomized this~     medication in over 120 participants for 4 weeks with 4 week observation without any notable~     side effects.~      We will test this compound (30 mg BID) as an adjunct treatment in a randomized,~     double-blind, 4-week trial, in which we will assess treatment efficacy, changes in~     peripheral cytokine concentrations, and, secondarily, antiprotozoal effects, (antibody~     titers to Toxoplasma gondii), an infection that is known to occur at higher rates in~     schizophrenia than healthy controls and may be related in part to the illness.~   "
71720|NCT02118597|"~     This prospective, national, multicenter, non-interventional study examined the use of triple~     combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and~     ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection.~     Dosing and treatment duration were at the discretion of the investigator in accordance with~     local clinical practice and local labeling. Participants were to be observed for the~     duration of their triple combination therapy and for up to 24 weeks thereafter.~   "
71721|NCT02118584|"~     This two-part, open-label extension (OLE) and safety monitoring (SM) study will examine the~     efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative~     colitis (UC) patients previously enrolled in etrolizumab Phase III studies.~   "
71722|NCT02118571|"~     The objective of this protocol is to develop items for a patient-reported outcome (PRO)~     measure to assess the patient's perspective and subjective experience of cognitive~     impairment associated with schizophrenia (CIAS).~   "
71723|NCT02118558|"~     This trial is a prospective, single center, unblinded, randomized, controlled study to~     assess the safety and efficacy of negative pressure wound therapy in preventing infections~     after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will~     be randomized to the treatment group and undergo the study intervention - (NPWT) The~     intervention will take place at the end of the surgery. The Patients that are randomized to~     the control group will receive standard treatment. Both groups will be assessed at two weeks~     and six weeks. period.~   "
71724|NCT02118545|"~     vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of~     platelets and is released upon their activation. Endothelial cell dysfunction as well as~     platelet activation often occur in liver disease and portal hypertension, which may lead to~     an increase in circulating vWF levels. Indeed, multiple studies have reported that liver~     disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore,~     increased circulating vWF -Ag Levels have been shown to be associated with increased~     mortality rates in patients with chronic liver disease. Within a prospective evaluation~     cohort, the investigators were able to document that patients with increased vWF-Ag levels~     prior to liver resection suffered from an increased incidence of postoperative liver~     dysfunction and morbidity. Within this prospective multicenter validation study, the~     investigators now aim to prospectively validate that circulating vWF-Ag prior to liver~     resection is a valuable marker to predict postoperative clinical outcome.~   "
71725|NCT02118532|"~     The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for~     the interventional treatment of new and non-stented restenotic lesions in the superficial~     femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.~   "
71726|NCT02118519|"~     Induction of autologous repair chondrogenesis to regenerate injured articular cartilage~     using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted~     culturing conditions.~   "
71727|NCT02118506|"~     The purpose of this study is to compare the effects of mental practice, associated with~     physical practice, on gait (cinematic parameters and mobility) in individuals with~     idiopathic Parkinson's disease. It is believed that familiarity with the normal gait~     pattern, associated with mental practice and physical practice can trigger significant~     changes in spatiotemporal and angular parameters that are not observed in the group not~     submitted to mental practice.~   "
71728|NCT02118493|"~     The biliary system normally empties into the intestines, however, some patients have biliary~     system narrow areas (stenosis) that prevent the bile to drain normally. These may be~     related to an underlying disease or previous surgery. Patients with this problem usually~     require tubes to be inserted into the biliary system to drain bile into a bag outside of~     their body, impacting their quality of life.~      The purpose of this research study is to use a laser device to try to re-open the biliary~     drainage system.~   "
71729|NCT02118480|"~     The study design was a parallel-group randomized trial with equal randomization. Recruitment~     and enrollment were conducted between June 2012 and January 2013. At base-line, clinical,~     cognitive and functional data was collected. Afterwards, the participants were randomly~     allocated to either the REHACOP group or the Control group. During 3 months the intervention~     with REHACOP program took place and at follow-up patients were again re-evaluated to~     evaluate the changes in clinical, cognitive and functional measures. Post-treatment~     assessment (finished by June 2013) was performed within the first week after completing the~     intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at~     changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological~     and neuroimaging assessements was also performed.~      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to~     improve cognition, clinical symptoms and functional disability of patients with Parkinson~     disease (PD).~   "
71730|NCT02118467|"~     The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive~     drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to~     norepinephrine and epinephrine. To investigate this hypothesis, the investigators are~     conducting a randomized double blind controlled trial comparing phenylephrine and~     vasopressin vs. norepinephrine and epinephrine in ICU patients with shock that is not~     responsive to IV fluids. All patients admitted to the adult intensive care units at the~     University of Chicago will be screened for eligibility.~   "
71731|NCT02118454|"~     The purpose of this study is to test whether twice-daily Interactive Voice Response (IVR)~     calls made at the estimated times of patients' antiretroviral (ART) medication dosing and~     three reminder calls for monthly clinic appointments, will result in improvements in ART~     adherence, appointment attendance, health indicators (CD4 cell counts), coping skills,~     social support, depressive symptoms, and other quality-of-life indicators, compared to a~     control group receiving one IVR assessment call each week, over six months.~      This is a randomized controlled trial of the IVR intervention with n=400 PLH taking first~     line ART in India on a twice-a-day dosing schedule. The research is supported by an~     Indo-U.S. Bilateral review and funding collaboration between NIH and ICMR. The research is~     being implemented in Kolkata by Drs. Smarajit Jana (PI, India) and Protim Ray (Project~     Director) at Durbar, a community-based organization providing HIV/STD prevention and~     community development programs with sex workers and other at-risk communities.~      This is Phase 2 of a two-phase pilot project. Phase 1 was a one-month no-control pilot~     (n=46) for feasibility, acceptability, and patient feedback on preferences for messaging~     content. Phase 2 has two sites, described as Phases 2A and 2b, which will occur~     simultaneously and differ only in their recruitment sites and corresponding sampling~     strategy (sample size, gender ratio, eligibility criteria) based on site population~     characteristics.~        -  Phase 2A will recruit n=80 women and n=20 men from Durbar's Mamata Care and Treatment~          Center (MCTC) (providing HIV testing and treatment linkage and support) and associated~          Mamata Network of Positive Women (MNPW), which focus on HIV+ sex workers and their male~          partners and networks.~        -  Phase 2B will recruit n=100 women and n=200 men from the ART Centre at the Calcutta~          School of Tropical Medicine (STM), which hosts the largest ART center in the Northeast~          Region of India and has over 3,000 active patients on first line ART.~      The sampling plan reflects the gender distribution of clients and patients at the two sites.~      Participants will be randomized within each site and gender sub-sample to receive:~        -  The IVR Intervention: consisting of two (2) automated voice calls (intervention~          messages) each day for six months, PLUS one IVR assessment call (consisting of four~          [4] questions) every week for 6 months; OR,~        -  The Control Condition: consisting of standard care, PLUS one IVR assessment call~          (consisting of four [4] questions) every week for 6 months.~      All participants will be interviewed in-person by a research team member at baseline and~     followed-up at 2- 4- and 6-months using structured questionnaires and recording information~     from the participant's personal medical record (i.e., their ART Card) to assess background~     characteristics and intervention impacts on ART adherence, health quality-of-life (i.e.,~     depressive symptoms, social support). All participants will receive one IVR assessment phone~     call (consisting of four (4) questions during each week of the 6 month study. Each~     once-a-week IVR assessment will ask about missed medication and the participant's~     health/quality of life, and participants will respond by keying in a 1 (yes) or 2 (no) on~     their mobile phone.~   "
71732|NCT02118441|"~     When a patient undergoes heart surgery, their Anesthesiologist will insert a tiny plastic~     tube, called a catheter, in the artery of the patient's wrist. This is called a radial~     artery catheter. A radial artery catheter allows accurate measurement of the patient's blood~     pressure during surgery. There are two common techniques for placing the radial artery~     catheter. The first is a blind technique whereby the Anesthesiologist feels for the pulse~     in the patient's wrist and places the catheter using the location of the pulse as a guide.~     The second technique, less commonly used, is one whereby the Anesthesiologist uses an~     ultrasound machine (painless to the patient) to see the artery, and thereby uses the~     ultrasound to guide the catheter placement. Our study will test the hypothesis that~     ultrasound-guided radial artery catheterization will have faster insertion times, with fewer~     complications compared with palpation-guided insertion.~   "
71733|NCT02118428|"~     The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole~     Blood to prevent Malaria transmission by transfusion of whole blood.~   "
71734|NCT02118415|"~     Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients~     with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)~   "
71735|NCT02118402|"~     Iron deficiency and anemia are health issues affecting mainly infants and women in~     developing countries. Iron deficiency in infancy can have long-lasting impact on cognitive~     and motor development of the child. Iron fortification has shown to be effective against~     anemia. However, in areas with a high burden of infectious diseases iron may increase the~     risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence.~     Therefore we want to assess the effects of home fortification of complementary food with two~     iron-containing micronutrient powders (MNPs) with and without the addition of a prebiotic~     (7.5 g of galactooligosaccharides as GOS-75) compared to a control on the composition of the~     gut microbiota of Kenyan infants. In this study we will use an MNP with a moderate iron dose~     of 5 mg, with 2.5 mg of Fe as NaFeEDTA and 2.5 mg of Fe as ferrous fumarate (+Fe). There~     will be 3 study groups MNP, MNP+Fe and MNP+Fe+GOS. The infants will be enrolled in the study~     at the age of 6-10 months and will consume a home-fortified maize porridge for four months.~     At baseline and endpoint (after 4 months of intervention), we will collect blood samples of~     the infants in order to assess anemia, iron status, and inflammation. Fecal samples (from~     child and mother) will be collected at baseline, 3 weeks and at endpoint in order to~     evaluate the changes in gut microbiota and gut inflammation.~      During the intervention, in a sub-group of children who receive broad-spectrum antibiotics,~     we will compare how the three different interventions modify the effect of antibiotics on~     the infant gut microbiota. We will opportunistically select children that are enrolled in~     the study and who become ill, and who are prescribed antibiotics by the local health care~     team, according to the local standard of care in the study area. Five additional stool~     samples from these children will be collected (day 0 (before the first antibiotic dose), 5,~     10, 20 and 40) to evaluate the changes in the gut microbiota and gut inflammation.~   "
71736|NCT02118389|"~     Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood~     pressure~   "
71737|NCT02118376|"~     GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes,~     reduce liver fat content, improve the inflammation state~   "
71738|NCT02118363|"~     Clinical assessment and monitoring of balance and arm function in stroke patients with~     sensor based measurement, in clinical and home environment.~   "
71739|NCT02118350|"~     The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure,~     heart rate, double product and psychobiological factors in hypertensive medicated women and~     acute effects of Mat Pilates Exercise on blood pressure of such individuals.~   "
71740|NCT02118337|"~     To evaluate the safety, tolerability and antitumor activity of MEDI0680 (AMP-514) given in~     combination with MEDI4736 and MEDI0680 monotherapy.~   "
71741|NCT02118324|"~     This is a pilot feasibility study to collect preliminary data for a large-scale exergaming~     intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia~     (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention~     control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a~     week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology~     graduate students for safety and compliance. Physical activity at baseline and at the end of~     study will be assessed using accelerometers. Outcome measures will include: anthropometrics,~     blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting~     glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and~     endurance, and strength.~   "
71742|NCT02118311|"~     This is a Simon's optimal two-stage phase II trial designed to estimate grade II-IV acute~     graft-versus-host disease (GVHD) after infusion of T regulatory (nTreg) in a fixed dose~     ratio to the combined CD3+ cell count of the two graft units in recipients of double UCB~     transplantation. The nTreg cells (manufactured from a 3rd cord blood unit) are infused on~     day 0 at least 1 hour after the 2nd unit of the double umbilical cord blood (UCB)~     transplant.~      The nTreg cells require an 18 day (±2 days) lead time based on the planned transplant day.~     The combined CD3+ cell content from the two graft UCB units is enumerated upon thaw (day 0).~     The patient then receives the number of nTregs cells from the 3rd cord product to achieve a~     Treg:CD3+ cells ratio of 5:1. The nTreg cell dose depends on the CD3+ cell content of the~     two graft UCB graft units, but it will not exceed the highest dose level safely tested in~     the ongoing University of Minnesota phase I Treg dose escalation study MT 2006-01.~   "
71747|NCT02118246|"~     Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in~     today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and~     primary source of musculoskeletal pain. Trigger point of the vastus lateralis muscle may~     pull the patella superiorly and laterally, increasing compression of the patellofemoral~     joint during physical activities, result in PFPS and anterior knee pain. The purpose of this~     study was to investigate the effects of Dry Needling & kinesio tape on trigger point of~     vastus lateralis muscle in PFPS subjects.~   "
71748|NCT02118233|"~     The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous~     carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or~     worsening of thinking or memory. There have been many studies on this subject, some finding~     that certain patients gain improvement in their brain function and others might get worse.~     The goal of this study is to discover which patients are more likely to have improved~     cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and~     stenting (CAS) are not investigational and are an accepted treatment for your condition. In~     addition, subjects that choose not to undergo surgery will also be included in this study.~   "
71749|NCT02118220|"~     The purpose of this research study is to determine the number of children who have symptoms~     of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's~     Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed~     concussion. This study is the first phase of a two-part study looking at the effects of~     anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently,~     the decision to continue with surgery in patients with a diagnosed concussion is based on~     clinical judgment by the patients.~   "
71750|NCT02118207|"~     SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this~     study was to see how exercise impacts microparticles (MPs), endothelial function, and venous~     gas emboli (VGE) over a series of dives.~      16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed~     by 5 days rest then 3 dives preceded by exercise. The other group completed the opposite~     protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before~     and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90~     min after surfacing. Exercise before diving consisted of 60 min running outdoors including~     8x4 min intervals at 90% VO2max effort.~   "
71751|NCT02118194|"~     The overall goal of this project is to determine if non-ambulatory persons with spinal cord~     injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be~     further trained to achieve more advanced skills for use in the home or work place~     environments and outdoor community mobility skills in the ReWalk exoskeleton.~   "
71752|NCT02118181|"~     The purpose of this study is to determine whether a supplementation containing~     β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a~     group of older women compared to a non interventional group~   "
71753|NCT02118168|"~     An observational study to prospectively follow-up the patients enrolled in the ISS T-002~     clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the~     persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and~     cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002~     and who have received at least 3 immunizations. The secondary endpoint is to define and~     validate novel laboratory tests for future efficacy clinical trials.~   "
71754|NCT02118155|"~     The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity~     laser therapy associated with connective tissue grafts to treat gingival recession.~   "
71755|NCT02118142|"~     People with poor insulin sensitivity do not respond normally to elevations in blood sugar.~     This may increase their risk of developing diabetes in the future. The purpose of this~     research study is to determine if the nutrient betaine, found in beets, spinach and wheat~     products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is~     believed to promote insulin sensitivity.~   "
71756|NCT02118129|"~     The purpose of this study is to examine whether a behavioural intervention changes~     attitudes, knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is~     that an educational component and use of a mobile smartphone 'app' will increase knowledge~     and/or intake of vitamin D.~   "
71757|NCT02118116|"~     Gatekeeper training is where people in the community are trained to recognize and identify~     those who are at risk for suicide and assist them in getting care. Gatekeeper training has~     been widely implemented around the world. There are two types of gatekeepers: 1) Designated~     gatekeepers - individuals who have been trained in helping professions (medicine,~     psychology, social work, nursing), and 2) Emergent gatekeepers - individuals who are not in~     caregiving roles (family members, police, teachers, clergy). Applied Suicide Intervention~     Skills Training (ASIST) has been implemented in Manitoba. However, a recent randomized~     controlled trial in First Nations community members (emergent gatekeepers) from the Swampy~     Cree Tribal Council (Northwestern Manitoba) demonstrated that the training had no positive~     impact on self-reported gatekeeper skills or behavior. Also, compared to a resilience~     retreat, the ASIST training was associated with a slightly higher likelihood of reporting~     suicidal ideation. The demonstrated lack of efficacy and the possibility of adverse effects~     associated with this training program in this vulnerable group have raised concerns about~     the safety and efficacy of ASIST. There were several key limitations of the previous study.~     First, the study only recruited community members (emergent gatekeepers), therefore findings~     may not be generalizable to designated gatekeepers (clinicians, nurses, counselors). Second,~     the study had a small sample size (n=55) and may have not been large enough to detect small~     effects that are often associated with educational interventions. Finally, the increase in~     distress in the ASIST trained group may not have been directly related to the training. To~     overcome the above limitations, we aim to conduct a larger evaluation of the safety and~     effectiveness of gatekeeper training that is occurring in Manitoba First Nations, Inuit and~     Metis communities. Based on previous work that suggests designated gatekeepers are more~     likely to benefit from gatekeeper training than emergent gatekeepers, we will examine these~     groups separately.~      Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors;~     2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3)~     ASIST will not be associated with an increase in suicidal ideation or distress.~   "
71758|NCT02118103|"~     The objectives of the proposed research are to quantify the impact on motor performance of a~     single SM intervention on surgical waitlist patients with degenerative Lumbar Spinal~     Stenosis (LSS) using a recently established lower extremity movement task: 1) using~     alterable levels of task difficulty that is resistant to learning and 2) using measurement~     of movement kinematics.~   "
71810|NCT02117414|"~     The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD~     (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance~     Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI~     scans may occur anywhere on the body).~   "
71811|NCT02117401|"~     To evaluate the effect and safety of mivacurium chloride in pediatric patients.~   "
71759|NCT02118090|"~     The investigators propose to leverage the unique infrastructures and expertise of National~     Centre for Parasitology Entomology and Malaria Control and the Pasteur Institute in Cambodia~     and combine modern fieldwork, including a mobile laboratory fully equipped for molecular~     biology and culture experiments, with state-of-the-art genomic analyses to investigate how~     Plasmodium vivax parasites respond to antimalarial drugs. The investigators will focus on~     resistance to CQ, the choice treatment for vivax malaria in most endemic countries, for~     which treatment failures have been reported in Cambodia. The study will address some of the~     key biological mechanisms limiting the efficiency of drug therapy in P. vivax, including the~     identification of genetic polymorphisms underlying drug resistance in Cambodian P. vivax.~     The findings will provide a first unbiased perspective on the mechanisms of drug resistance~     in P. vivax and have the strong potential to significantly improve malaria control in~     Southeast Asia.~   "
71760|NCT02118077|"~     Compare the effect of G17DT with that of placebo on the survival of subjects with advanced~     pancreatic cancer.~   "
71761|NCT02118064|"~     This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in~     patients with refractory colon cancer who had been previously treated with an~     Irinotecan-based chemotherapy.~   "
71762|NCT02118051|"~     Patients who have had or are expected to have a poor ovarian response (POR), because they~     meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of~     alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro~     fertilization (IVF).~      In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus~     daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first~     seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH)~     antagonists~   "
71763|NCT02118038|"~     To assess the impact and to identify the main risk factors for psychological and cardiac~     morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum~     hemorrhage~   "
71764|NCT02118025|"~     The investigators aimed to evaluate the clinical results and the inflammatory response of~     the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary~     revascularization (OPCABG).~      This is a randomized and prospective study in 230 patients with indications for coronary~     surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were~     the clinical and biochemical results, intra-operative outcomes and the determination of 19~     inflammatory circulating markers, 17 of them for the first time analyzed comparing both~     techniques.~   "
71765|NCT02118012|"~     Background:~      - Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common~     cause of serious liver disease in the United States. Many people have few if any symptoms.~     It can lead to cirrhosis, which can cause liver failure and cancer. Researchers want to~     study how a medicine called chlorcyclizine works in patients with hepatitis C. They want to~     see if it can be used to treat hepatitis C alone or when used with the standard hepatitis C~     treatment drug ribavirin.~      Objectives:~      - To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the~     drug ribavirin.~      Eligibility:~      - Adults with chronic hepatitis C who either have never been treated for it or have relapsed~     after prior treatment.~      Design:~        -  Participants will be screened with medical history, physical exam, blood and urine~          tests, and a questionnaire. They will also have an ultrasound of their abdomen and~          electrocardiogram. Some of these tests will be repeated throughout the study.~        -  Participants will spend 3 days as an inpatient to be monitored while starting study~          drug. They will be assigned randomly to a group and will begin taking the study drug.~          Blood will be taken frequently.~        -  Group I will take the study drug twice a day for 28 days.~        -  Group II will take the study drug twice a day and ribavirin twice a day for 28 days.~        -  Participants will visit the clinic every 7 days for 28 days.~        -  After participants stop taking the study drug, they will have 5 follow-up visits over 3~          months.~   "
71766|NCT02117999|"~     The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and~     safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat~     progressive keratoconus in comparison with standard cross-linking (standard CL).~   "
71767|NCT02117986|"~     The study hypothesis is that the loading dose of intravenous colistin (6 million of~     international units) is associated with greater clinical and microbiological efficacy, and~     reduced mortality of critically ill patients infected by multidrug resistant Gram- negative~     bacilli, compared to a scheme without loading dose.~   "
71768|NCT02117973|"~     The purpose of this prospective randomized study is to evaluate iAssist with respect to~     radiographic, clinical and economic outcomes in comparison to conventional instrumentation~     in primary total knee arthroplasty using the Persona knee system among patients with~     BMI>=30.~   "
71769|NCT02117960|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with~     cardiovascular disease.~   "
71770|NCT02117947|"~     The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in~     a high risk, medically underserved population of maternal smokers. The program is called~     Philadelphia FRESH (Family Rules for Establishing Smokefree Homes). Participants are~     recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After~     determining study eligibility via telephone screen, all participants complete an in-home~     pre-intervention interview that includes self-reported smoking history, current smoking and~     exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms,~     weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a~     biomarker used to detect SHSe).~      Participants are randomized after baseline to receive either (a) a moderately intensive (up~     to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered~     over a 16-week period by counselors trained and supervised by investigators, or (b) an~     enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for~     SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of~     intervention process, factors associated with intervention effects, and intervention~     outcomes that include child urine cotinine (to measure level of SHSe) and participant saliva~     cotinine (to verify self-reported smoking quit status). Interviewers and data management~     staff remain blind to the treatment assignment. All procedures are implemented after signed~     informed consent and were approved by Temple University's Institutional Review Board.~   "
71776|NCT02117869|"~     Grapefruit (GF) contains furanocoumarin (FC) which is known to irreversibly inhibit the~     activity of cytochrome P450-3A (CYP3A) enzymes in the human gastrointestinal tract (PAINE~     2005). Because CYP3A enzymes are integral in the metabolism of some drugs, co-ingesting GF~     or GF Juice (GFJ), which inhibits CYP3A, along with drugs reliant on CYP3A for metabolism~     can significantly alter the drugs kinetic properties and result in elevated plasma drug~     concentrations which may be toxic. The Citrus Research and Education Center at the~     University of Florida has developed a new GF hybrid (GFH) which contains low FC content and~     which may not inhibit CYP3A enzyme activity, and therefore may be safe to co-ingest with~     drugs that require CYP3A activity for metabolism. The investigators hypothesize that low FC~     GFHJ will not inhibit CYP3A to the degree that regular GFJ does, and will not significantly~     affect midazolam kinetics compared with regular GFJ. Midazolam is an FDA approved probe drug~     for CYP3A activity and has been used previously to establish an interaction between GFJ and~     midazolam. This study will evaluate the concomitant administration of midazolam and low FC~     GFHJ, regular GFJ, or water to evaluate the significance of this interaction.~   "
71777|NCT02117856|"~     This study is a randomized clinical trial to compare patient satisfaction and prosthetic~     outcomes with lower dentures retained by one or two implants. The investigators long-term~     objective is to establish evidence of the cost-effectiveness of a single implant~     intervention for improving tolerance to complete dentures. The investigators MAIN AIM will~     be to investigate patient satisfaction between and within groups with mandibular dentures~     retained by one or two implants over five years, and SECONDARILY to investigate the survival~     of implants, and the frequency of events to maintain the dentures and prosthetic attachments~     as clinically serviceable. Furthermore, multivariate analysis can assess the prediction of~     patient satisfaction with implant dentures based on various possible factors including age,~     health, demography and socioeconomic status, number of implants, and maintenance needs.~     Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a~     measure of overall satisfaction and various specific aspects of satisfaction such as~     appearance, stability and comfort of the dentures.~      The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are~     at least as satisfying to patients over a five years period as those retained by two~     implants for the same period.~      The SECONDARY HYPOTHESES are that:~      i) there is no difference over five years between groups in the survival of original~     implants, or in the number of events for maintenance of the dentures or implant attachments;~     and ii) using each treatment group as it's own control, there is no change in patient~     satisfaction with lower dentures retained by either one or two implants during the five year~     loading period.~   "
71778|NCT02117843|"~     The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and~     Efficacy of 'AVI' Stent for Treating Coronary Revascularization.~   "
71779|NCT02117830|"~     This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and~     positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of~     Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each~     Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and~     the positive control.~      In each Treatment Period subjects will be admitted to a Clinical Research Unit where study~     drug will be administered as three (3) daily single doses. Treatment Periods will be~     separated by a washout of at least 7 days between Periods.~   "
71780|NCT02117817|"~     The purpose of the first part of this study or the dose escalation portion of the study is~     to determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at~     the same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer~     that does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the~     least toxic and most effect dose of this drug combination for treatment. Once this dose is~     established, it will be used for the dose expansion phase of the study where we will~     determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial~     or ovarian cancer. We will see whether the combination of both drugs improves the response~     and survival of patients treated on the two drug regimen. Also we will try to find out~     whether there are changes in tumors that can help us determine what patients are more likely~     to respond to BKM120 and Abraxane.~   "
71781|NCT02117804|"~     The purpose of this study is to determine the predictive performance of the Early Screen for~     Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is~     that the ESDP differentiates between patients in a regional community hospital who would~     benefit from those who would not benefit from early discharge-planning intervention as~     measured by problems and unmet continuing care needs, quality of life, length of stay, and~     referrals to post-acute services.~   "
71782|NCT02117791|"~     This local, prospective, non-interventional, multi-center study includes patients treated~     with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/~     persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of~     400 patients (valid for safety analysis). This study is performed as an all-case~     investigation. The treatment of Riociguat is performed based on the product label in Japan.~     The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and~     effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is~     carried out once a year for 7 years at the longest to collect information on safety and~     effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is~     terminated, observation of a patient ends. For each patient, the investigator records data~     as defined in the protocol at each evaluation point by using the Electronic Data Capture~     (EDC) system. The duration of the study is approximately 9 years from launch.~   "
71783|NCT02117778|"~     This study is designed to evaluate lung function and pain control of continuous~     supraclavicular versus suprascapular versus interscalene nerve catheters in subjects~     undergoing total shoulder replacement. The investigators hypothesize that all three groups~     would have similar pain control; the supraclavicular and suprascapular groups may have~     better lung function.~   "
71812|NCT02117388|"~     The purpose of this study is to evaluate the relative efficacy and effectiveness of specific~     components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and~     cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).~   "
71813|NCT02117375|"~     The purpose of this study is to evaluate the prognostic value of early focal lesions and~     early diffuse lesions on ambulatory disability progression within 5 years after clinical~     onset.~   "
71784|NCT02117765|"~     In type 1 diabetes (T1D), immune defense cells in the body attack and destroy~     insulin-producing beta cells leaving affected people with a lifelong need for daily insulin~     injections. Even with insulin injections, blood glucose (sugar) control is imperfect and~     leads to many health complications and a shortened life span. This is a pilot clinical trial~     to test the safety of a drug, ustekinumab, in 20 adult subjects with recent-onset T1D.~     Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly~     effective and safe and so the investigators hope to see a similar effect in T1D. This trial~     will also be used to determine the best dosage and frequency of the drug to be given to~     people with T1D to help design future studies on the drug's effectiveness. The investigators~     hope that if the drug can block immune cells soon after the development of diabetes, any~     remaining insulin-producing cells may be protected, and regenerate, thus producing more~     insulin so that individuals may be insulin free, or require less insulin.~   "
71785|NCT02117752|"~     This study will determine the cumulative irritation potential and sensitization potential of~     dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.~   "
71786|NCT02117739|"~     This study will evaluate the potential of dapsone gel and its vehicle to cause a~     photoallergic reaction after repeated application and irradiation to the skin of healthy~     volunteers under controlled conditions.~   "
71787|NCT02117726|"~     Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol,~     midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been~     reported to be used together with midazolam in ICU and the combination of propofol and~     midazolam is most commonly used, but things follow include a high incidence rate of~     delirium, But the combination of midazolam and dexmedetomidine may have complementary~     advantages and could have be a better choice for sedation. In this study, we attempted to~     observe the effects of two different drug regimens on delirium incidence rates in severe~     ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .~   "
71788|NCT02117713|"~     This is a multicentre, extension study of LUM001 in children diagnosed with Alagille~     Syndrome who have completed participation in a core LUM001 treatment protocol. The primary~     objective is to evaluate long-term safety and tolerability of LUM001. Efficacy will be~     assessed by evaluating the effect of LUM001 on the biochemical markers and pruritus~     associated with Alagille Syndrome.~   "
71789|NCT02117700|"~     Although weight reduction through physical activity-based interventions is the mainstay~     therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and~     typically unsuccessful. This affirms the extreme need for alternate and/or adjunct~     therapies. Although convincing data from animal studies and a few adult human studies on the~     benefits of a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions~     including NAFLD have emerged, studies in children are scarce. Therefore, the aim of the~     study is to test the use NAC as an innovative approach to attenuate the progression of NAFD~     in obese children with biopsy proven NASH. The central hypothesis is that NAC~     supplementation will reduce liver fat and liver enzymes and ameliorate risk factors of~     cardiometabolic disease in children with NAFLD.~   "
71790|NCT02117687|"~     This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi~     for the management of dry eye.~   "
71791|NCT02117674|"~     The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its~     possible additive contribution in the detection of important lesions, namely polyps and~     cancers, compared to the standard forward-viewing approach, with and without the addition~     of the right-colon retroflexion technique, in a series of patients undergoing back-to-back~     screening or surveillance colonoscopies in a randomized fashion.~   "
71792|NCT02117661|"~     Obesity is one of the main causes of the metabolic syndrome, a condition which is becoming~     more common in Canada and worldwide. Metabolic syndrome is a name for a group of heart~     disease risk factors that occur together: obesity, diabetes, high blood pressure, and high~     cholesterol. These patients have a high risk of developing narrowing and blockages of blood~     vessels which occur when fat and cholesterol build up in the walls of blood vessels and form~     plaque. This is called atherosclerosis. Plaque buildup leads to stroke, heart attacks, and~     death. We do not understand the underlying mechanisms of the metabolic syndrome and we do~     not have a treatment for it. L-carnitine, a dietary supplement, has been shown to treat some~     components of the metabolic syndrome, but its benefit to reduce plaque in the blood vessels~     has never been studied. Recently there has been some controversy because a new study showed~     that L-carnitine could make heart disease worse in some patients. Our goal is to study~     whether supplementation with L-carnitine does in fact prevent or reduce buildup of plaque in~     blood vessels of patients with the metabolic syndrome. This novel therapy has the potential~     to decrease the burden of heart disease in obese and diabetic patients with the metabolic~     syndrome.~   "
71793|NCT02117648|"~     The purpose of this study is to assess how the body handles LY2835219 when it is given with~     another drug called clarithromycin. The study doctor will measure the amount of LY2835219~     that is absorbed into the blood stream and the time that it takes to remove LY2835219 from~     the body. The safety and tolerability of these drugs will be studied.~      Each participant will complete 2 study periods in fixed order. After screening, Period 1~     will last approximately 8 days and Period 2 will last approximately 15 days. Participants~     who complete Period 2 may continue to receive LY2835219 in 28-day cycles until~     discontinuation criteria are met.~   "
71794|NCT02117635|"~     The primary aim of this Phase II trial is to determine whether it is sufficiently likely~     that CTX DP treatment at a dose level of 20 million cells improves the recovery in the use~     of the paretic arm in acute stroke patients to justify a subsequent larger prospectively~     controlled study.~      This study will evaluate the safety and efficacy of intracerebral CTX DP at a dose level of~     20 million cells in patients with paresis of an arm following an ischaemic middle cerebral~     artery (MCA) stoke. Eligible patients will have no useful function of the paretic arm a~     minimum of 28 days after the ischaemic stroke (a modified NIH Stroke Scale (NIHSS) Motor Arm~     Score of 2, 3 or 4 for the affected arm).~   "
71795|NCT02117622|"~     This study is conducted in Asia. The aim of the study is to evaluate long term safety and~     efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine~     clinical practice in India.~   "
71796|NCT02117609|"~     The objective of this study is to determine whether a supplementation with a new~     high-protein oral supplement can improve the evolution of functional parameters in elderly~     patients in nursing homes.~   "
71797|NCT02117596|"~     Damage and scarring of a transplanted kidney has become the most common cause of loss of the~     transplanted kidney. This kidney damage is a complex process caused by many factors~     including injury during obtaining and transplanting the kidney, injury from the immune~     system, injury from infections, and injury from drugs used to stop rejection. This injury~     leads to scars that decrease the kidney's ability to function properly, and over time the~     kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent~     rejection. However, when used over time it has been shown to cause chronic damage and~     scarring in the transplanted kidney.~      The purpose of this experimental study is to determine whether children can safely be~     withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent~     research studies in adult transplantation have demonstrated that with the use of Rapamycin®~     (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase~     in rejection, with decreased scarring in the kidney, and with improvements in kidney~     function and survival of the kidney. A total of 50 children will enroll in this study at~     university centers around the country. This study will last about 3 years.~   "
71798|NCT02117583|"~     To estimate the effect of food on the pharmacokinetics and relative bioavailability of~     oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K~     taken whole or after chewing in healthy volunteers. We have described below the two cohorts~     each with two arms in this crossover study by listing them as four Arms/Groups in order to~     capture the differences between the cohorts prior to the crossover and after the crossover.~     14 participants are planned for the first cohort and 18 participants are planned for the~     second cohort.~   "
71799|NCT02117570|"~     This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85~     years, who will each receive 3 doses of vaccine. The study will assess the safety and~     tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.~   "
71800|NCT02117557|"~     -  Compared with traditional open colectomy, laparoscopic surgery is associated with less~          pain, earlier recovery, and better cosmetic outcome, and its short- and long-term~          oncologic outcomes have been demonstrated.~        -  In experienced surgeons' hands, single incision laparoscopic surgery is increasingly~          performed for colorectal disease, and even for malignant lesion because of its reduced~          incision-associated morbidity and scarring.~        -  However, the safety and efficacy of single incision laparoscopic surgery for colorectal~          cancer has not yet been evaluated. Thus, the prospective randomized trial comparing~          single incision versus conventional laparoscopic surgery for colorectal cancer is~          needed.~   "
71801|NCT02117544|"~     The purpose of this study is to evaluate the visual performance of a new multifocal High ADD~     contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD~     Contact Lens.~   "
71802|NCT02117518|"~     It is well established that CD8 and CD4 T cells reactive against defined islet antigens are~     associated with initiation and progression of Type 1 Diabetes (T1D). In previous work, we~     have demonstrated that it is possible to redirect T cells against pathogenic T cells via~     chimeric peptide/MHC/CD3-zeta receptors in a peptide-specific manner and to prevent, or~     inhibit diabetes in NOD mice. In this study we intend to extend this approach to T cells of~     T1D patients. Working hypothesis: Beta cell-reactive CD8 T cells of human T1D patients can~     be immuno-targeted by their own gene-modified cytotoxic T lymphocytes (CTLs). Aims: Our~     major aim is to demonstrate, in a set of ex-vivo experiments, such immunotargeting with T~     cells derived from T1D patients at the Ziv Medical Center. To this end we will stimulate and~     expand autoreactive CD8 cells in blood samples of T1D patients and target them, ex-vivo,~     with genetically-reprogrammed CTLs which are present in the same blood samples.~   "
71803|NCT02117505|"~     The purpose of this study is to evaluate the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test)~     compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed~     conditions at a single dose of 150 milligram (mg).~   "
71804|NCT02117492|"~     The purpose of this study is to evaluate the possible impacts of two techniques of vaginal~     cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal~     cuff closure and the impact that these techniques have on vaginal length, sexual function,~     and overall complication rates.~   "
71805|NCT02117479|"~     To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine~     for the treatment of advanced or metastatic pancreatic cancer.~   "
71806|NCT02117466|"~     In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in~     extra-hepatic colorectal metastases. The investigators hypothesize that uptake of~     89Zr-cetuximab is required for response to cetuximab. If no uptake is present the~     investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.~      The investigators will evaluate the clinical benefit rate of cetuximab in the patients with~     and without uptake. The ultimate goal is to create a selection tool that can predict~     response of cetuximab.~   "
71807|NCT02117453|"~     The purpose of this study is to assess whether rosuvastatin could reduce the subclinical~     markers of atherosclerosis and the incidence of major cardiovascular events in patients with~     primary necrotizing vasculitides.~   "
71808|NCT02117440|"~     This study is designed to apply functional imaging, Fluorodeoxyglucose_Positron Emission~     Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized~     Tomography (V/Q SPECT), before treatment and then again during treatment to see if it~     predicts how well the treatment works for your cancer and how well your lungs function~     during treatment. A Computerized Tomography (CT) will also be performed along with both of~     these procedures to help the researchers see clearly where your cancer or your healthy lung~     is located. The researchers also perform blood tests in this study to look for markers in~     your blood to see if it helps them determine your risk of developing side effects from~     radiation to the lungs. The researchers hope that this study will help them in the future to~     design radiation treatment plans that provide the best treatment for each individual~     patient.~   "
71809|NCT02117427|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment.~   "
71839|NCT02117037|"~     This prospective study aimed to validate a new prognostic approach of endothelial progenitor~     cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made~     prospectively by two centers of Inter -region South Mediterranean,~   "
71814|NCT02117362|"~     The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the~     FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02~     is a galectin. Galectins are a family of proteins that have numerous functions in normal~     mammalian biology including the facilitation of cell-cell interactions, regulation of~     cell-death and regulation of immune system responses. The hypothesis is that a safe dose of~     GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.~   "
71815|NCT02117349|"~     The purpose of the study is to show that Raplixa plus gelatin sponge is better than gelatin~     sponge alone in stopping mild to moderate bleeding in children having surgery~   "
71816|NCT02117336|"~     This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose~     extension phase. The objective of the dose escalation phase is to evaluate the~     pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of~     the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of~     P1446A-05 in 14 patients at the MTD level.~   "
71817|NCT02117323|"~     A prospective observational study on corneal opacities in infants and children (1 month to~     18 years old) will be conducted at CHLA. Most of these cases will be due to congenital~     corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious~     keratitis. Sixty (60) subjects will be recruited. The children will be examined under~     anesthesia with a portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an~     operating microscope-style mount at CHLA will be used for the intraoperative scans. Both~     cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map,~     endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The~     anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth,~     trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or~     posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence~     of cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if~     indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will~     be measured with a tonopen (Reichert).~   "
71818|NCT02117310|"~     This is a feasibility study in which indocyanine green (ICG) will be administered during~     routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal~     flap harvest will be necessary. The research entails administering ICG, which is already~     widely used during open neurosurgical procedures, to identify the blood supply at two~     distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after~     final positioning of the nasoseptal flap to ensure its viability before ending the case.~   "
71819|NCT02117297|"~     Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab~     Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.~   "
71820|NCT02117284|"~     Rubidium is a newly approved nuclear medicine imaging drug or 'tracer' used to look at blood~     flow in the heart. This tracer is given using a special pump called an 'elution system'~     which is considered investigational. This means the device is not yet approved by Health~     Canada for general use, but it has been approved for use in this study. It has been used~     routinely in this hospital since 2010.~      The purpose of this study is to confirm proper operation of the pump. It may also help~     identify areas for future improvement. The study data may be used for safety reporting to~     the Ministry of Health or to Health Canada. The study will enroll 2,400 patients in 6~     hospitals across Canada. The University of Ottawa Heart Institute (UOHI) will enroll up to~     1,200 patients.~   "
71821|NCT02117271|"~     The investigators hypothesized that the treatment of obstructive sleep apnea (OSA) with~     continuous positive airway pressure (CPAP) will positively affect the appearance of the~     patient. The purpose of this study is to compare effects of one month of treatment of CPAP~     and placebo on appearance of patient with OSA in a randomized and crossover study.~      The investigators will include 30 consecutive patients (both genders, aged 30 to 60 years)~     referred to a sleep clinic, with history of snoring, excessive sleepiness, and severe OSA.~     Patients will be excluded if presenting previous treatment for sleep-disordered breathing,~     previous diagnosis of chronic diseases that interfere with sleep patterns and history the~     chronic use of alcohol, sedatives or drugs of abuse, in the last month.~      Patients will be randomized into two treatment arms: 1) Placebo - use of nasal dilator~     strip; and 2) CPAP - use of CPAP. After one month of treatment in the first randomized arm,~     patients will be submitted to two weeks without treatment (washout period). After washout~     period, patients will be assigned to the treatment crossover, i.e., patients in arm 1) will~     receive CPAP therapy and patients in arm 2) will receive placebo treatment, during a period~     of one additional month. Excessive sleepiness (Epworth Sleepiness Scale) and quality of life~     (Functional Outcomes of Sleep Questionnaire - FOSQ) will be evaluated in the three~     experimental times: baseline (immediately before treatment), one month (after one month of~     treatment defined at baseline), and 2 months (after one month of treatment crossover).~      All patients will be photographed in the three experimental times. The photographs will be~     displayed in a randomized order for 100 observers (general population, both genders, similar~     socioeconomic status and education), who will be unaware of the conditions of the study. The~     observers will rate the faces for attractiveness (very unattractive to very attractive),~     health (very sick to very healthy), and tiredness (not at all tired to very tired) on a 100~     mm visual analogue scale. Age perceived will be rated by the observers' evaluation.~      Presence of porphyrins, coloration/evenness, vascular features, porosity, wrinkles and skin~     texture of the patient's face will be analyzed using the VISIA TM system. Skin hydration and~     skin elasticity will be measured out from forearm. Collection of dermatological assessments~     will be conducted in three experimental sampling times.~   "
71822|NCT02117258|"~     The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM~     plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic~     Adenocarcinoma.~   "
71823|NCT02117245|"~     The objective of this study is to assess the bioavailability of the MGCD265 formulation~     following oral administration under fed conditions (Treatment-1) as compared to fasting~     conditions (Treatment-2) in healthy male and female volunteers.~   "
71824|NCT02117232|"~     Colonoscopy has become the gold standard in detection of colonic polyps and colon cancer.~     However, colonoscopy causes significant abdominal discomfort and abdominal pain during and~     after the procedure, requiring intravenous sedation and use of analgesics. The discomfort~     and pain are mostly caused by air insufflation and intubation difficulties during~     advancement of the colonoscope in order the reach the cecum.~      Study Hypothesis: Use of the Visualization Balloon will facilitate advancement of the~     colonoscope and will eliminate the need for colonic distention with the air or CO2, which~     can shortened the length of the procedure, reduce patient's discomfort and can decrease~     amount of sedatives and analgesics used during colonoscopy.~   "
71825|NCT02117219|"~     This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity~     of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine~     in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents~   "
86339|NCT01927263|"~     The purpose of this study is to investigate similarity between NI-071 and infliximab(the~     comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately~     responding to Methotrexate.~   "
71826|NCT02117206|"~     The symptoms and severity of arterial disease is secondary to perfusion deficit. The~     specific alteration of the mitochondrial function of ischemic skeletal muscle plays an~     important role, and therapeutic enhancing mitochondrial function are associated with a~     clinical improvement with increase in the walking distance of the patient.~      In severe ischemia, reperfusion required is accompanied by a deleterious episode through a~     worsening of endothelial dysfunction (impaired pathway of nitric oxide (NO)), majorant~     alteration of cellular energy and the hormonal and inflammatory responses. This is~     reperfusion syndrome, which can lead to grave consequences. Our goal is to limit~     mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the~     NO pathway by in situ addition of its precursor, L-arginine. Our working hypothesis is that~     this cellular improvement will be accompanied by an increase in systolic pressure index and~     an improvement in the walking distance.~      Method: This is a trial with direct individual benefit, comparative, randomized,~     prospective, single-center, double-blind, versus placebo.~   "
71827|NCT02117193|"~     Although the effects of acute alcohol intake and sleep deprivation on exercise performance~     lacks evidence in the literature, in many situations, they occur simultaneously. Once the~     alcohol affects physiological processes, the processes that occur during sleep can be~     impaired, such as: suppression of GH release, action of neurotransmitters and~     neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to~     suppression of REM sleep. These changes promote a significant functional impairment such as~     a reduction in alertness and modification in reaction time, which affects the performance of~     any activity of daily and professional life. However, the combined effects on the physical~     performance variables, such as aerobic and neuromuscular performance lack of evidence in the~     literature.~   "
71828|NCT02117180|"~     This pilot study aims to establish whether a low FODMAP diet is safe in children with~     functional gastrointestinal disorders. The practicality of implementing this diet will be~     evaluated as well as symptom improvement and quality of life. A larger intervention trial,~     if deemed appropriate, will then follow to assess symptom efficacy in children.~   "
71829|NCT02117167|"~     Open label multicentric randomized phase II trial, using high throughput genome analysis as~     a therapeutic decision tool, aimed at comparing a targeted treatment administered according~     to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in~     Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as~     immunotherapy with maintenance therapy in patients without actionable genomic alterations or~     non eligible to substudy 1 (immune substudy 2).~   "
71830|NCT02117154|"~     This study aims to evaluate relative contributions of fasting plasma glucose and~     postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship~     between HbA1c, CGM, serum fructosamine and eAG, will also be looked into.~      HYPOTHESES:~        1. Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor~          glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role~          with lower HbA1c levels.~        2. There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian~          patients.~   "
71831|NCT02117141|"~     -  Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in~          both fed and fasted states~        -  Evaluate the safety and tolerability of the test compound administered orally~   "
71832|NCT02117128|"~     We will investigate the efficacy and safety of using tranexamic acid by intravenous,~     intra-articular and combinational administration to reduce blood loss during total knee~     replacement. We hypothesize a combined intra-articular and single intravenous dose protocol~     of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and~     extra-articular bleeding site with little or no systemic absorption and subsequent systemic~     side effects.~   "
71833|NCT02117115|"~     Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell~     transplant, and radiographic evidence of mucosal inflammation will be correlated with the~     subsequent development of acute graft versus host disease. The primary endpoint is the~     feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant~     period, as defined by the risk of contrast-related nephropathy or allergic reaction.~   "
71834|NCT02117102|"~     Urinary tract infection is most common serious bacterial infection in children who admit~     into the emergency department (ED). However the collection of urine from young children is~     time consuming process. So many children and their family guardian waste time until medical~     disposition established.~      In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique~     for newborn, that bladder and lumbar stimulation technique is fast and safe.~      The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation~     technique (BLST) for pediatric patient in ED.~   "
71835|NCT02117089|"~     The purpose of this study is to investigate the combined training effectiveness of~     mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after~     stroke.~   "
71836|NCT02117076|"~     The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin)~     versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.~   "
71837|NCT02117063|"~     The main purpose of this study is to determine if the Go Girls! program to take place at the~     Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to~     introduce girls to a fun, non-threatening environment of exercise with peer support,~     improves scores on a physical activity enjoyment scale (PACES). Information regarding~     enjoyment of physical activity before and after the program will allow objective evaluation~     of whether the program is achieving its mission. Qualitative responses to the questionnaires~     will give program leaders a better sense of potential attitudes and barriers to regular~     exercise for teen girls. These responses will be used to shape activities during this or~     future programs for teens. Anthropometric (e.g. body weight, blood pressure, waist~     circumference) and biochemical (bloodwork) data will allow us to determine whether any~     change in metabolic risk factors can be seen from this 6-month once weekly intervention.~   "
71838|NCT02117050|"~     This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment~     satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently~     being treated with, but are considering discontinuing treatment with Tecfidera™.~   "
71840|NCT02117024|"~     This study will test whether vaccination with viagenpumatucel-L combined with low-dose~     cyclophosphamide will prolong the survival of patients with non-small cell lung cancer~     (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease~     compared with chemotherapy alone. Patients will be randomized 2 to 1 into the~     viagenpumatucel-L arm and the chemotherapy alone arm, respectively.~   "
71841|NCT02117011|"~     Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery~     is associated with better outcomes in early stage breast cancer compared to surgery alone.~     Fatigue is one of the most important side effects of RT because it can decrease patients'~     quality of life.~      Studies found that physical activity (PA) may help to improve quality of life in cancer~     survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical~     inactivity over a long period of time may lead to rapid energy and physical function loss.~      PA intervention studies in patients undergoing RT have included mostly White patients. There~     is no evidence on African American patients undergoing RT. The purpose of this study is to~     examine the efficacy of a structured, moderate-intensity, aerobic exercise program in~     reducing cancer-related fatigue in African Americans undergoing RT for localized breast~     cancer.~   "
71842|NCT02116998|"~     This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be~     randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will~     receive up to 3 doses at 4 week intervals.~      Following the third dose, subjects will be inoculated intranasally with S. pneumoniae~     serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained~     pre-inoculation, and then 2, 7 and 14 days after inoculation.~      Subjects will also be monitored for safety and tolerability throughout the dosing period,~     and then for 12 months after their last dose.~      The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing~     colonization rates and magnitude of colonization following the S. pneumoniae challenge.~   "
71843|NCT02116985|"~     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of~     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it~     difficult to judge the depth of anesthesia according to traditional hemodynamics index such~     as heart rate and blood pressure.In case of this, the investigators design this research to~     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided~     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.~   "
71844|NCT02116972|"~     This study is a double-blind, randomized, parallel group, dose-ranging, single dose design.~     The study will be conducted in male and female patients ≥ 40 years of age with~     osteoarthritis (OA) of the knee.~      Approximately 300 patients with OA of the knee will be randomized to one of three treatment~     groups (1:1:1) and treated with a single intra-articular (IA) injection of:~        -  20 mg FX006,~        -  40 mg FX006, or~        -  normal saline.~      Each patient will be evaluated for a total of 24 weeks following a single IA injection.~     Following screening, safety and efficacy will be evaluated at 6 out-patient visits (Days 1~     [Baseline], Weeks 4, 8, 12, 16, 20 and 24).~   "
71845|NCT02116959|"~     The purpose of this study is to test the safety of the treatment combination of alternating~     standard chemotherapy and another (melphalan) chemotherapy at different interval schedules.~     Researchers want to find out what effects, good and/or bad, the treatment combination has on~     the patients and their retinoblastoma.~   "
71846|NCT02116946|"~     This is a randomized controlled clinical trial to investigate the effectiveness, safety and~     tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy~     in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment~     groups:~        1. Leukocyte-rich PRP injection + exercise~        2. Leukocyte-poor PRP injection + exercise~        3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and~          severity of adverse events as reported by both patients and study physicians during the~          first 12 weeks after initiation of treatment, (2) patient-rated tolerability of~          treatment; (3) the change in function (VISA score) and treatment success (global~          improvement scale) over six months of a post-injection exercise protocol.~   "
71847|NCT02116933|"~     Grafting of autologous stromal cell trial is a prospective study comparing routine fat~     grafting versus stromal vascular fraction enriched fat grafting.~   "
71848|NCT02116920|"~     AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for~     HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can~     be incorporated to triage excess false positives from primary screening for cervical cancers~      Objectives:~        1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for~          HPV genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples.~        2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as~          secondary screening test, with the reference standard of colposcopy with biopsy, to~          triage women found positive in primary screening by VIA , in a population based~          screening for cancer of cervix.~        3. To determine number of false positives in the primary screening test after testing VIA~          positives with a known high specificity secondary screening test (HPV-DNA HC II )~          compared to HPV E6/E7 mRNA testing.~      Study Population: Women in the age group of 30-65 years, who test positive on primary~     cervical screening test VIA will be enrolled for the proposed diagnostic tests along with~     reference standard of colposcopy with guided biopsy.~      Methodology:~      Women in the age group of 30-65 years undergoing routine cervical cancer screening through~     hospital ( Preventive Oncology screening clinic) and community based screening programs with~     abnormal test result using the primary cervical cancer screening test VIA will be recruited~     in the study. The primary screening test VIA will be administered by application of 5%~     Acetic Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp.~     VIA will be considered to be positive if definite acetowhite lesions are visualized close to~     the squamocolumnar junction.~   "
71849|NCT02116907|"~     This is an open-label, single-dose study in healthy male subjects. The study will have 2~     phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will~     consist of a Screening Period and a Baseline Period, during which each subject's study~     eligibility will be determined and baseline assessments will be conducted.~   "
73474|NCT02095639|"~     The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally~     leads to a side effect of brain inflammation. Patients with treatment resistant depression~     who are planning to take ECT will be subsequently approached to participate in the study.~   "
71850|NCT02116894|"~     The primary objective of this open-label phase Ib trial is to determine the maximum~     tolerated dose and the recommended phase II dose for the combination of PF-03446962 plus~     regorafenib in patients with metastatic colorectal cancer. The secondary objectives are to~     describe the safety and tolerablility, and to describe the clinical activity of PF-03446962~     plus regorafenib in terms of response rate and progression free survival~   "
71851|NCT02116881|"~     Despite of technological advances in surgery, incisional hernia and bowel obstruction remain~     frequent surgical complications. To date, the relationship between these two types of~     surgery and the occurrence of incisional hernia remains unclear. This is an observational~     study to evaluate outcomes of incisional hernia with respect to the incision site and~     adhesion-related bowel obstruction after open and laparoscopic colorectal surgery.~   "
71852|NCT02116868|"~     The purpose of this study is to determine whether analgesia guided by pupillary reflex~     during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and~     postoperative morphine).This is a prospective, randomized, controlled study performed in two~     centers.~   "
71853|NCT02116855|"~     A multi centre two year long term escalating dose tertiary prophylaxis study on the efficacy~     and cost saving of individualized low dose prophylaxis regimens for boys with severe~     hemophilia A in China staring with a low dose regimen in step I, an escalated low dose~     regimen in step II and a tailored dose regimen based on individual PK profiles in step III.~     The dose escalation criteria are adjusted according to patterns and frequencies of joint~     bleeding and assessed in each subject every 3 months. Efficacy of the 3 different dose~     regimens are measured by the Annualized Joint Bleeding rate (AJBR) as a primary end point~     and the Hemophilia Joint Health Score (HJHS ) and QoL scores (CHO-KLAT and PedsQoL) , image~     studies of target joints by Ultrasound, X-ray and MRI examinations, consumption of factor~     VIII and inhibitor rates as secondary end points.~   "
71854|NCT02116842|"~     Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose,~     accidental injection in a blood vessel or slow absorption from the area of injection. The~     risk of toxicity when performing regional anaesthesia can be reduced significantly by~     injecting the optimal dose of local anaesthetic at the correct site.~      To date most of the local anaesthetic dose finding studies for epidural labour analgesia has~     focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study~     is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic~     for epidural analgesia in labour.~      The dose determined from this research trial will guide the anaesthetists to the optimal~     starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to~     decreased chances of toxicity and will improve patient safety.~      We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5~     cm) requesting epidural analgesia to answer the research question based on the continual~     reassessment method. Patients will be recruited according to well-defined criteria. They~     will be fully informed about the study and have the choice of not participating or opting~     out at any time during the study. It is not going to affect the kind of treatment they~     receive. The experts in the field with full safety precautions will perform this study at St~     James' Hospitals, Leeds.~   "
71855|NCT02116829|"~     The aim of this study is to examine the effects in humans of a moderate butter intake on~     risk markers of cardiovascular disease compared to a diet with the same amount of olive oil~     (refined and therefore without polyfenols).~      The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides.~     The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as~     well as the inflammatory marker hs-CRP.~   "
71856|NCT02116816|"~     This study consists of two parts. The first part of the study looked at the absorption of~     three different polyphenol preparations into the blood, the variability of their absorption~     and whether their absorption could be enhanced by mixing with pollen shells. For this~     purpose 12 healthy volunteers were recruited. All participants received all the 3~     supplements with and without mixing with pollen shells so they had a total of 3 tests. For~     each test six blood samples were taken over an 8 hour period. Urine samples were also~     collected.~      Oligopin was selected from the first study. The second part of study aims to look at the~     effects of Oligopin on endothelial function by assessing vascular tone and function in~     healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity~     (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will~     also be recorded to provide a clear clinical assessment of the effects of this preparation~     (if any) upon vascular function. The effects of Oligopin will be compared to a placebo~     (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A~     total of 24 healthy volunteers will be recruited for this study.~   "
71857|NCT02116803|"~     The study allows continued safety follow-up of patients who are on single agent dovitinib or~     dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which has~     met its primary endpoint and are benefiting from the treatment as judged by the~     investigator.~   "
71858|NCT02116790|"~     Findings from the investigator's lab and others' show the involvement of the brain's~     mesolimbic circuitry in pain perception and evaluation, as well as during the transition~     from acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the~     main neurotransmitters in this circuitry, and it is possible it could have an intimate role~     in pain processing, chronicity, and related anatomical and functional neuroplasticity. In~     this study, the investigators first need to know if the combination of l-dopa and Naproxen~     is safe and efficacious in humans with acute pain, and if so, at what doses. For the present~     study, healthy pain-free participants will be injected with a small bolus of capsaicin~     subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this~     study because it causes a characteristic inflammatory response that is almost always~     accompanied with pain, has a well-validated dose-response curve, and has effects that will~     go away completely in a few hours after administration, causing no permanent damage to study~     subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in~     thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a~     scale from 0-10). Participants will also be given study medication in the form of a placebo,~     one drug, or a combination of drugs before capsaicin injection to allow for any analgesic~     effects to peak before pain onset. For those receiving active medication, they will either~     receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which~     will be in one of two different doses). This will allow the investigators to investigate (1)~     whether co-administration of naproxen and l-dopa has analgesic effects in low levels of~     acute pain in humans, (2) if this combination is pain-alleviating, whether it is equally as~     or more efficacious than naproxen, which is the clinical standard of treatment, and finally~     (3) what dose provides the most analgesia.~   "
73475|NCT02095626|"~     The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary~     graft dysfunction after lung transplantation.~   "
71859|NCT02116777|"~     This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide~     and to see how well they work in treating younger patients with tumors that have not~     responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving talazoparib together with temozolomide may work better in~     treating younger patients with refractory or recurrent malignancies.~   "
71860|NCT02116764|"~     This study is a longitudinal and cross-sectional evaluation of patients with Chronic~     Granulomatous Disease (CGD) who received or are receiving hematopoietic cell transplantation~     (HCT) for their disease under a variety of protocols used by participating institutions~     compared to a control non-HCT group receiving standard care. Investigators at multiple~     centers caring for patients with CGD in North America and 3 centers in Europe will~     participate. Patients with CGD will have been treated according to institutional practice~     and protocols. Investigators will enroll these patients as subjects in this protocol. This~     study will investigate which patients benefit most from HCT, and what types of transplants~     are optimal for patients with CGD, in the context of overall outcomes in CGD patients with~     and without transplant.~   "
71861|NCT02116751|"~     The purpose of this study is to determine the frequency of renal and bone toxicity in HIV~     infected patients receiving antiretroviral therapy, and the outcome in terms of treatment~     change or/and virological failure, in relation with the presence of classical factors, such~     as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and~     the effects of antiretroviral medication.~   "
71862|NCT02116738|"~     The investigators want to share our study that is the Comparison of Modified Limberg Flap~     Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the~     Surgical Treatment of Sacrococcygeal Pilonidal Sinus.~   "
71863|NCT02116725|"~     Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing~     with detergents e.g. shower gels may deplete the zinc stores in the skin.~      The purpose of our study is to see whether repeated washing with zinc containing shower gel~     of superficial wounds will result in increased healing.~   "
71864|NCT02116712|"~     Lymphangioleiomyomatosis (LAM) is a rare lung disease that mostly affects women of~     childbearing age. In LAM, abnormal, muscle-like cells begin to grow out of control in the~     lungs. As a result, air can't move freely in and out of the lungs. In some cases, this means~     the lungs can't supply the body's other organs with enough oxygen.~      This study is being conducted to find out what dose of a drug called saracatinib is best~     tolerated by people with LAM. This drug has been tested in patients with certain types of~     cancer but is not currently approved by the United States Food and Drug Administration~     (FDA). Saracatinib may work in cancer by preventing the growth, movement and invasiveness of~     cancer cells. The use of saracatinib to treat LAM is considered experimental. Preliminary~     testing already completed suggests that the study drug, saracatinib, may suppress certain~     substances in the lungs of patients with LAM thus may be effective in slowing down the~     disease process~   "
71865|NCT02116699|"~     Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own~     mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in~     immune factors which may provide immunostimulatory effects when administered oropharyngeally~     to extremely premature infants during the first weeks of life. The investigators hypothesize~     that infants who receive oropharyngeal mother's colostrum and milk will have significantly~     lower rates of infection and improved health outcomes, compared to infants who receive a~     placebo.~   "
71866|NCT02116686|"~     The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart~     failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal~     cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or~     adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases~     remains undiagnosed and untreated especially due to cost and time delay for polysomnography~     examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are~     developed. Some methods, based on nocturnal ECG analysis showed promising results but they~     are not validated and adapted for cardiac population. Thus, the goal of present study is to~     test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.~   "
71867|NCT02116673|"~     Background: Head injury is a common presentation to family medicine clinics and emergency~     departments (EDs), and the majority will not result in intracranial injury requiring~     neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It~     is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS).~     Research in the management of MTBI and prevention of PCS has been scarce to date. Although~     expert consensus recommends cognitive rest and graduated return to usual activities, these~     and other interventions are not based on prospective clinical evidence.~      Objective: The purpose of this study is to determine if providing graduated return to usual~     activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms~     post-injury as compared to providing usual ED MTBI discharge instructions.~      Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority~     randomized trial.~      Patient Population: Male and female patients presenting to the ED ages greater than 17 and~     less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting~     complaint of head injury.~      Outcomes: The primary outcome of this study is to determine if patients whom receive~     graduated return to usual activity discharge instructions have more clinically significant~     decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients~     who received usual care MTBI discharge instructions. Secondary outcomes include the~     intervention group's compliance with the intervention, comparison of PCSS between groups 4~     weeks after initial ED visit, comparison of groups' number of return visit(s) to either an~     ED or physician's office, and the mean number of days of school or work missed for each~     group.~      Hypothesis: Given cognitive rest and graduated return to usual activities are concepts~     recommended by expert consensus, it is expected patients who follow the graduated return to~     usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks~     after ED discharge.~   "
71868|NCT02116660|"~     To evaluate changes in renal function, efficacy, and safety when switching from a~     combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r)~     to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human~     immunodeficiency virus (HIV)-1 participants with suppressed viremia and impaired renal~     function.~   "
71869|NCT02116647|"~     In India, precisely northern states, skewed sex ratios, female feticide and higher child~     mortality rates for girls have become serious concern. The female child mortality as a~     result of son preference have increased during the last several decades .Since families~     cannot know the sex of the fetus due to Indian government policies, maltreatment and serious~     neglect has been tools to ensure there are few survivors.~   "
71870|NCT02116634|"~     Whether the mesenchymal injection on ALS patients is effective or not?~   "
71871|NCT02116621|"~     Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in~     a trial and error fashion. Clinicians prescribe a treatment to a patient and then wait and~     see if the treatment is successful. If the treatment is unsuccessful, they will try a~     different treatment. The disadvantage to this method is that it may take a long time to find~     a successful treatment.~      The purpose of the PREEMPT Study is to test whether using a mobile phone application~     (Trialist app) that allows patients and their health care providers to run personalized~     experiments comparing two pain treatments is more effective than usual care. Patients~     download the app, and working with their clinicians, set up a personalized trial that makes~     sense for them. Every day they answer questions to track levels of pain and side effects of~     treatment, such as fatigue and constipation. Once the personalized trial has ended, the~     responses to these daily questions on each treatment will be compared. During a regular~     clinic visit, the patient and the clinician will review visual displays of the results to~     facilitate treatment decision-making. Approximately 250 patients will be enrolled in the~     study. Half the patients will use the app and review results with the clinician, and half~     the patients will continue with their regular care (i.e., will not use the app). The two~     groups will be compared to see if using the app is successful in improving long term pain~     outcomes. The goal of the intervention using the Trialist app is to help patients engage~     actively and collaboratively with their clinicians and identify effective treatments more~     quickly.~   "
71872|NCT02116608|"~     This study plans to learn more about the different ways used to treat tracheostomy~     granulomas. Investigators want to see which standard of care method (steroid application,~     silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.~   "
71873|NCT02116595|"~     Presently, the gold standard for testing diet acid intake is a urine collection done for~     many hours, usually 24 hours, which must be analyzed in a research lab for net acid~     excretion. So, getting information about diet acid intake is difficult. Many people have~     suggested doing a much simpler test, which is checking the pH of the urine when you wake up.~     But, no one has studied if this simpler method is a valid method for estimating the 24 hour~     net acid excretion. Diet acid load may be important in many diseases associated with aging,~     such as loss of bone and muscle, and the development of kidney disease.~   "
71874|NCT02116582|"~     The objective of this study is to evaluate the efficacy and safety of enzalutamide treatment~     in patients with progressive metastatic castration-resistant prostate cancer previously~     treated with abiraterone acetate.~   "
71875|NCT02116569|"~     The purpose of this study is to evaluate the tolerability and safety of Daratumumab in~     Japanese participants with relapsed (the return of a medical problem) or refractory (not~     responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow,~     characterized by the presence of abnormal proteins in the blood).~   "
71876|NCT02116556|"~     Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes~     of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme~     of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes~     of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal~     decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves~     liver function and reduces the complications of decompensated alcoholic cirrhosis.~      The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the~     development of infections associated with AAH and analyze its consequences.~   "
71877|NCT02116543|"~     This proof of concept study is designed to evaluate the safety, tolerability,~     pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1,~     GT-2 or GT-3 chronic HCV.~   "
71878|NCT02116530|"~     This randomized phase III trial studies antiemetic therapy with olanzapine to see how well~     they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and~     vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy.~     Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron~     hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with~     chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by~     blocking brain receptors that appear to be involved in nausea and vomiting.~   "
71879|NCT02116517|"~     Green tea is one of the most popular beverages in the world. It is believed to have~     beneficial effect in prevention and treatment of many diseases, one of which is reducing~     LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese~     with high LDL level.~   "
71880|NCT02116504|"~     One of the main potential causes of these failures of BP therapy response is the development~     of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by~     neutralizing them or modifying their clearance and they may be associated with BP-specific~     hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD)~     immunization are thus major goals in BP development. This prospective study (ABI-RA) will~     assess the occurrence of ADAb using standardized and validated assay(s) and also cellular,~     genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept,~     infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity.~     Patient-related factors that might predispose an individual to an immune response will be~     taken into account: underlying disease, genetic background, immune status, including~     immunomodulating therapy and dosing schedule.~   "
71881|NCT02116491|"~     BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter~     (visual sputum suctioning system or VSSS), which the investigators previously tested in~     vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen~     catheter.~      PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum~     suctioning system in mechanical ventilated patients in respiratory intensive care unit~     (RICU). The investigators compare the weight of secretions collected, vital signs, and~     tracheal wall injury between two groups of patients randomized to have VSSS combined with~     closed system suction (CSC) suction and patients having CSC suction alone.~      HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less~     change of vital signs than conventional CSC.~   "
71882|NCT02116478|"~     The purpose of the study is to compare the clinical results for patients suffering from~     plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.~   "
71883|NCT02116465|"~     The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and~     carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by~     means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).~      Additionally, to describe and compare the safety and tolerability of the two investigational~     treatments administered to healthy subjects.~   "
71884|NCT02116452|"~     The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect~     in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in~     infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that~     prebiotics reduce the severity of the disease.~   "
71885|NCT02116439|"~     The main objective of this study is to determine the average total number of violent events~     per observation period occurring in the emergency department at the Nîmes University~     Hospital. The list of violent events is pre-determined and based on a series of interviews~     with emergency department staff.~   "
71886|NCT02116426|"~     The main objective of our study is to evaluate the diagnostic value of copeptin testing in~     association with troponin HS testing during pre-hospital care (ambulance care) in the~     treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS~     but not ST+.~   "
71887|NCT02116413|"~     The main objective of this study is to evaluate in a population of patients with septic~     shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as~     responders to the fluid challenge (increase of at least 15% of ITV in aortic) at the end~     of vascular filling (T10) and becoming non-responders 20 minutes after the end of the~     fluid challenge (T30) and whether this proportion is greater than 10 points.~   "
71888|NCT02116400|"~     The main objective of this study is to evaluate decision-making using the Iowa Gambling Task~     (IGT) among patients with euthymic bipolar disorder according to their personal history of~     suicide attempt (suicidal vs. not suicidal ).~   "
71889|NCT02116387|"~     The main objective of this study is to evaluate in patients with chronic low back pain~     (lasting for more than 3 months and not postoperative) the effect of an instrumental~     rehabilitation using the I-Moove ® device compared to a conventional physiotherapy~     rehabilitation for ambulatory postural stability (mean and standard deviation of excursions~     from the center of gravity) without visual control, 6 weeks after the start of the~     rehabilitation protocol. We focus on the relative variation between the values obtained on~     day 0 versus 6 weeks, via measures performed on a force platform. The results will be~     stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).~   "
71890|NCT02116374|"~     The bacterial diversity of HIV patients digestive microbiota seropositive is poorly~     understood, it remains to be defined.~   "
71891|NCT02116361|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared~     with placebo as treatment for major depressive disorder (MDD) in adult females.~   "
71892|NCT02116348|"~     Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The~     economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion~     in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total~     cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental~     retardation, delayed speech development add psychological burden of the disease on the~     family as well as economic burden.~      Mental retardation is the major problem in children with cerebral palsy. Improving mental~     development will have a positive effect on quality of life for the child and his family.~     Treating associated impairments (mental retardation) with Cerebrolysin will improve mental~     development and quality of life, and will decrease the economic burden in children with~     cerebral palsy.~   "
71893|NCT02116335|"~     Our bodies respond differently to stress. Animal studies by the investigators have found~     that endothelin-1 plays a role in regulating blood pressure in response to stress. This~     study is an extension of the investigators previous animal work to evaluate the role of~     endothelin-1 during stress in humans.~   "
71894|NCT02116322|"~     This research is being done to investigate if a new technique to biopsy the pancreas will~     lead to a larger amount tissue material that can be analyzed. Investigators have called the~     technique the corkscrew technique and believe it will allow obtaining a larger biopsy~     sample during the endoscopic ultrasound examination. The corkscrew technique uses a~     clockwise rotational movement to drive the needle into the pancreatic mass (like a wine~     bottle opener twists and buries itself into a cork). It is believed that this will lead to a~     better biopsy sample than the usual way and therefore result in a higher chance of a~     diagnosis.~   "
71895|NCT02116309|"~     This research is being done to see if using a combination of rectal indomethacin and~     epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a~     type of gastrointestinal endoscopy).~   "
71896|NCT02116296|"~     The ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural~     models for prevention of obesity, with a particular focus on children. It will primary aim~     to influence children's behaviours and prevent obesity in early childhood. The proposal will~     identify key behaviours related to early childhood obesity and their determinants and~     evaluate behavioural models and educational strategies. Based on the obtained insights at a~     local level, a multidisciplinary team will develop and implement a school based family~     involved intervention programme that could be applied on a European scale. Process, impact,~     outcome and cost-effectiveness evaluation will be conducted to support decision making for~     European Public Health Policy. The combined use of Precede-Proceed Model and Intervention~     Mapping will provide the framework for the development, implementation and evaluation of the~     ToyBox intervention. To achieve this, the project will be subdivided into 10 Work Packages~     (WPs). This carefully planned stepwise approach will include systematic reviews, secondary~     analyses of existing data sets, focus group research and school policies overview. The~     ToyBox project consortium spans the necessary multidisciplinary variety of experts such as~     public health experts, epidemiologists, nutritionists, physical activity experts,~     pedagogists, psychologists, behavioural scientists, nutritionists, paediatricians, early~     childhood psychologists, health economists, totalling 15 partners, from 10 countries. The~     consortium, consists of 11 universities, 1 research institute, 2 advocacy groups and a small~     to medium enterprise (SME) representing all regions of Europe. The consortium has ample~     experience in conducting and coordinating multi-centre international research as well as~     undertaking dissemination activities to all relevant stakeholders.~   "
71897|NCT02116283|"~     Smokers will use a smartphone app on a smartphone provided for the study that will passively~     sense and record information about their activities. Information collected from the~     smartphone app will be used to develop future smartphone apps that will predict when an~     individual is at risk of smoking.~   "
71898|NCT02116270|"~     The aim of this study is to investigate the impact of renal function and dialysis techniques~     on the percentage of senescent T lymphocytes.~   "
71899|NCT02116257|"~     While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the~     degree of postoperative pain, it can also affect the patient's outcome by several adverse~     effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of~     patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect~     needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing~     effect, and is used widely for post operative pain management. This study aims to see the~     opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk~     PONV patients.~   "
71900|NCT02116244|"~     Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye,~     tear film, and related ocular tissues. Millions of people suffer from one form of the~     disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers~     experience a broad range of symptoms including discomfort, irritation, burning, itching,~     redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue.~     Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide~     release and subsequent desensitization to further stimulation of the trigeminovascular~     system. This provides a pharmacological rational for intranasal route of administration for~     disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical~     studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received~     Civamide via intranasal administration experienced lacrimation (tearing). This led to the~     hypothesis that Civamide Nasal Solution might be an appropriate treatment for Dry Eye~     Syndrome.~   "
71901|NCT02116231|"~     The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with~     concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.~   "
71902|NCT02116218|"~     Pain control is a common and serious problem in cancer patients. Although WHO has developed~     a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to~     severe pain in their daily life. When patients are with acute exacerbation or aggravate of~     pain, they usually visit the emergency department for more help.~      Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used~     as a complementary therapy among patients with cancer. It can not only relieve pain in~     cancer patients, but also can reduce some of the side effects caused by some treatment.~      This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient~     with acute pain onset through emergency department with objective Traditional Chinese~     Medicine assessment.~   "
71903|NCT02116205|"~     The purpose of this study is to compare the immune responses of two different doses (1.0 mg~     and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan~     virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a~     blind, participants in the two-dose group will receive one dose of normal saline placebo.~     All of the groups will also receive a booster dose 6 months after first vaccination. The~     results will help to determine which dose and vaccination schedule will be best to move~     forward in the vaccine development process.~   "
71904|NCT02116192|"~     This research study intends to learn about whether early intervention can help to prevent~     non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents~     who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to~     join the study. Patients who agree to participate in the study will be randomized into~     either the intervention group or the control group. The intervention group will follow a~     low-fructose diet. In addition, participants will be asked to return to the clinic for 4~     follow-up visits during a 6-month interval.~   "
71905|NCT02116179|"~     The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month~     follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV~     intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse~     treatment clients to either the experimental intervention or to a wait list control group;~     and 2) to evaluate both participant and interventionist acceptability of this novel~     DVD-based intervention.~      They study hypothesis are the following:~        1. participants in the intervention condition will report greater reductions in sexual~          risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up~          compared to the control group;~        2. participants will report greater reductions in drug risk behaviors (e.g., sharing~          injection equipment, drug use during sex) from baseline to 3 month follow-up compared~          to the control group;~        3. participants who report more HIV prevention information, motivation, and behavioral~          skills will report fewer sexual risk behaviors.~   "
71906|NCT02116166|"~     The purpose of this research study is to investigate how and why the loss of muscle mass~     occurs with aging. Tissue collected from young subjects will be compared to previously~     collected tissue from elderly subjects, as well as previously collected data on muscle~     function/mass to further investigate cellular and molecular pathways that have recently been~     shown to be important for the aging process in muscle. The Principal Investigator (PI) and~     the study team will look for specific proteins (called biomarkers) that can be present in~     the muscle tissue in various amounts in different individuals. This study will increase the~     investigators understanding of the processes of muscle atrophy (loss of mass) and functional~     loss at older age and will help to find new treatments and interventions aimed at improving~     the quality of life and independence of America's rapidly expanding elderly population.~   "
71907|NCT02116153|"~     Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency~     department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the~     biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction~     (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of~     non-STEMI and the detection of troponin in individuals that would have been classified as~     unstable angina with former assays. As many patients are detected with elevated troponin~     values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased.~     Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that~     allow specific identification of myocardial infarction. The aim of this study is to develop~     a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high~     specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED~     patients.~   "
86340|NCT01927250|"~     The purpose of this study is to determine whether multi-dimensional wellness program (diet,~     art and biofield therapy) influences the quality of life for those with different health~     status in Japan.~   "
71908|NCT02116140|"~     Obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF) are states~     of metabolic demand and sympathetic nervous system (SNS) activation. In patients with sleep~     apnea and HF, continuous positive airway pressure (CPAP) initially may reduce left~     ventricular (LV)stroke volume (SV) but subsequently improves and LV function. This may~     relate to an early beneficial effect on myocardial energetics through early reduction in~     metabolic demand that subsequently leads to improved efficiency of LV contraction. However,~     it is not clear whether long-term adaptive servo-ventilation (ASV) favorably affects cardiac~     energetics. Any such benefit may also relate to reduced sympathetic nervous system (SNS)~     activation. However its effect on myocardial SNS function is also not well studied.~      In a pilot study we demonstrated early (6 week) beneficial effects of CPAP in patients with~     OSA and HF. The current proposal (AMEND) is a unique substudy of the recently funded~     ADVENT-HF trial (Adaptive Servo Ventilation for Therapy of Sleep Apnea in HeartFailure)~     (NCT01128816; CIHR; D. Bradley, PI).~      We propose to evaluate the long-term (6 month) effects of ASV on daytime 1) oxidative~     metabolism; 2) the work metabolic index (WMI) as an estimate of mechanical efficiency; 3)~     myocardial sympathetic nerve (SN) pre-synaptic function; and 4) heart rate (HR) variability~     in patients with HF and coexisting OSA or CSA. In conjunction with echocardiographic~     measures of LV stroke work, positron emission tomography (PET) derived [11C] acetate~     kinetics will be used as a measure of oxidative metabolism, to determine the WMI. [11C]~     hydroxyephedrine (HED) retention will be used to measure cardiac SN pre-synaptic function.~      Primary Hypotheses: In patients with chronic stable HF and CSA or OSA without excessive~     daytime sleepiness (EDS), long-term (6-month) ASV therapy yields:~        1. Beneficial effects on daytime myocardial metabolism leading to a reduction in the rate~          of oxidative metabolism as measured by [11C]acetate kinetics using PET imaging;~        2. Improvement in energy transduction from oxidative metabolism to stroke work as measured~          by an increase in the daytime work-metabolic index.~   "
71909|NCT02116127|"~     The purpose of this pilot study is to examine the feasibility of conducting a multi-site~     double-blind randomized controlled trial whose aim will be to evaluate the effectiveness of~     transcranial direct current stimulation (tDCS) for treatment in pregnant women with moderate~     to severe major depression.~   "
71910|NCT02116114|"~     We have as hypothesis that the aquatic aerobic physical training program can help promote~     beneficial adaptations on the cardiovascular, respiratory and systemic inflammation~     variables, functional capacity and quality of life in patients with chronic obstructive~     pulmonary disease (pulmonary emphysema).~   "
71911|NCT02116101|"~     This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The~     objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:~        1. Improving intestinal digestion and bowl movement;~        2. Adjusting blood total Cholesterol and Triglycerides levels;~        3. Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and~          Bifidobacterium) in gastrointestinal tract;~        4. Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in~          gastrointestinal tract.~   "
71912|NCT02116088|"~     Children with externalizing problem behaviour are at risk of developing educational~     impairment, because of their problems in rule following, social behaviour and attention.~     This behaviour represents a great challenge for teacher. In addition, time pressures and~     conflicts with colleagues are the most common sources of stress for teachers. Till now~     teachers receive no evaluated training which in particular regards externalizing problem~     behaviour. Therefore we develop and evaluate an indicated prevention program for elementary~     school teachers with children with externalizing problem behaviour. All teachers of a~     participating school are given a general overview of externalizing problem behaviour~     (etiology, diagnosis) and information on evidence-based treatments for children with~     externalizing problem behaviour in school settings. Single teachers will then participate in~     a 12 week coaching in which they learn to apply classroom management techniques, strategies~     to improve their relationships with children, behaviour modification techniques and~     cognitive interventions to specific target children. The coaching intervention is based on~     functional behavioural analysis and provides teachers with evidence-based strategies which~     focuses on one target child.~      Longitudinal data will be collected in a within-subject control group design. Dependent~     measures include teacher and observer reports.~   "
71913|NCT02116075|"~     Study comparing caudal prolotherapy to conventional steroid for chronic low back pain~   "
71914|NCT02116062|"~     The introduction of surgical robots in the OR revolutionized a number of specialties (i. e.~     urology, gynecology, digestive surgery). Robots are currently used in many situations and~     the list of appropriate indications is growing rapidly. There are many potential advantages~     of robotics in eye surgery such as increased precision and maneuverability, better~     ergonomics, improved patient access to surgeons and surgical training. As a result, robotics~     might improve patient care. The Da Vinci© robot has been used for 10 years in experimental~     conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular~     foreign bodies, lens capsules and vitreous. The authors reported a lack of precision~     resulting from poor visualization and the absence of microsurgical instruments. These~     elements were considered to be hurdles to further clinical investigation. The new Da Vinci~     Si HD© robot has been available since 2009 at the IRCAD center and more recently in~     Strasbourg University Hospital. It provides greater magnification and better resolution of~     the operative field than the previous model. We performed since 2012 various ocular surface~     surgeries on porcine eyes at the IRCAD center. The aim of the present trial is to perform~     the same procedures (amniotic membrane transplantations, pterygium surgeries, corneal~     grafts) in a clinical setting with the Da Vinci Si HD© system.~   "
71924|NCT02115932|"~     People with diabetes can have nerve damage in their extremities (peripheral neuropathy), and~     this can lead them to being less able to maintain their balance when they are standing,~     walking or performing complex movement tasks in their day-to-day life. This results in them~     being more prone to falls, and consequent injuries. The purpose of this study is to~     determine whether providing strength and balance retraining (in the form of specific~     physical exercises or activities) can help people with diabetic peripheral neuropathy regain~     their ability to maintain their balance, increase their confidence in performing~     balance-based activities and improve their quality of life.~   "
71945|NCT02115659|"~     Triptolide was shown in experimental studies to inhibit the cyst formation and growth in~     ADPKD models, while triptolide-containing formulation was revealed to potentially slow the~     disease progression in several proteinuric ADPKD patients in our clinical practice. It~     remains to be shown the effect of triptolide-containing formulation on total kidney volume~     (TKV) enlargement and renal function protection in ADPKD patients.~   "
71946|NCT02115646|"~     The investigators are studying the appearance and function of burn scars after treatment~     with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic~     appearance and range of motion will improve with treatment.~   "
76852|NCT02051400|"~     The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is~     equal or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for~     novice users in a simulated airway manikin.~   "
71915|NCT02116049|"~     Men who have sex with men (MSM) remain disproportionately represented in the national~     HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM~     sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure~     of an HIV-positive status may be a key factor responsible for male-male HIV transmission.~     There are no known intervention programs whose primary focus is to help MSM develop~     requisite skills to disclose their status to casual sexual partners. The development of such~     interventions is essential because of the numerous repercussions for not disclosing when one~     is HIV-positive such as legal prosecution and the transmission of HIV. In a previous~     intervention development study (R21MH067494) the research team created and tested a 4~     session intervention found to be promising for increasing disclosure to casual sexual~     partners. The purpose of the proposed research is to further refine and enhance our HIV~     disclosure intervention (DI) designed to increase disclosure to casual sexual partners and~     reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative~     effectiveness of a disclosure intervention to an attention control case management group~     (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore~     differential treatment responses to the disclosure intervention and ACCM on the basis of~     ethnicity, age, and education level as well as examine the mediating effect of baseline~     frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear~     on the relationship between intervention type and the outcome. Finally, the investigators~     will test how treatment engagement, retention and expectations predict subsequent disclosure~     and risky sexual outcomes.~   "
71916|NCT02116036|"~     The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood~     clotting (thrombosis). APS is among the most common cause of heart attack and stroke in~     patients under the age of 50 and is particularly prevalent in patients with autoimmune~     conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to~     prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires~     frequent bloodwork monitoring, and many medications or foods can alter its effect, which can~     put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation~     that prevents blood clots that does not require bloodwork monitoring and that has fewer~     interactions. This study is a pilot feasibility study which will: 1) examine our ability to~     identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of~     these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily~     rivaroxaban administration. The investigators propose to treat eligible patients with~     rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their~     rates of bleeding and thrombosis will be monitored as secondary outcome measures.~   "
71917|NCT02116023|"~     The study is a human dietary test meal study that is a randomized, controlled, double blind,~     cross over design with 3 intervention arms that will investigate the subjective ratings of~     satiety in response to different levels of processed whole orange compared with a~     sugar-matched isocaloric control~   "
71918|NCT02116010|"~     The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage~     treatment of E. coli or P. aeruginosa wound infections in burned patients.~   "
71919|NCT02115997|"~     This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study~     in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis [GPA])~     or microscopic polyangiitis. Participants will be treated with rituximab (Ristova) and~     glucocorticoids. Rituximab will be administered by intravenous (IV) infusion at a dose of~     375 milligrams per meter square (mg/m^2) body surface area once weekly during Weeks 1 to 4.~     Participants will also receive one or three pulses of methylprednisolone (1000 milligram~     [mg] each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per~     kilogram per day). The dose of oral prednisone will be reduced as per evaluation by the~     investigator till the participant is completely off the drug. The participants will be~     followed up for duration of 6 months from the date of starting rituximab therapy with three~     follow-up visits at Days 52, 112 and 172. All adverse events occurring during this period~     will be captured.~   "
71920|NCT02115984|"~     The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory~     activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases~     in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with~     distant metastases).~   "
71921|NCT02115971|"~     The aim of this pilot study is to analyze the effect of a 12-week specific jump training~     compared with conventional therapy in patients with chronic functional instability of the~     ankle. It is to be evaluated to what extent the symptoms in of chronic functional~     instability of the ankle can be influenced in everyday life.~   "
71922|NCT02115958|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
71923|NCT02115945|"~     Total knee prosthetic replacement causes severe postoperative pain. Various analgesic~     techniques have been used in pain control. Comparison of epidural and femoral nerve block is~     lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare~     the effects of epidural and femoral block on acute and chronic postoperative pain.~   "
71936|NCT02115776|"~     The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin~     (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a~     chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental~     extractions.~      The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show~     higher effectiveness in reducing the prevalence and duration of bacteremia following dental~     extractions, than that achieved with the classical amoxicillin regimen.~   "
71925|NCT02115919|"~     Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted~     infection (STI). They are distressing to those who have them and are a source of viral~     shedding and transmission to others. Treatment of warts is aimed at destruction of the~     lesion.~      Objectives:~        1. Establish safety of Multikine in treatment of perianal condyloma.~        2. Describe presence of anal HPV and anal dysplasia in participants with perianal~          condyloma.~        3. Describe adverse effects associated with Multikine in the management of perianal~          condyloma.~      Design:~      Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal~     warts will be referred to study by their primary clinician. All participants will undergo~     baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count,~     measurement, photography), and complete a baseline questionnaire. Cohort A participants will~     undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14~     days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no~     serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using~     the same schedule but with a dose of 400IU per treatment. Each participant will undergo anal~     Pap and anal HPV subtyping once weekly during treatment. Condyloma characterization (count,~     measurement, photography) will occur prior to each treatment. After treatment completed,~     participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap,~     anal HPV subtyping, and perianal condyloma characterization (count, measurement,~     photography) performed.~      Subjects:~      The study will be open to adult men and women who are HIV-infected who receive medical care~     from the Naval Medical Center San Diego.~      Main Outcome Measures:~        1. Perianal wart characterization [count, measurement (in millimeters diameter)],~          photography)~        2. HPV subtype in anal canal~        3. Anal dysplasia cytologic grade~        4. Questionnaire responses~        5. Adverse effects experienced during treatment, recorded in symptom log~   "
71926|NCT02115906|"~     Growth hormone (GH) plays a pivotal role in the regulation of body composition including~     ectopic lipid deposition in insulin sensitive organs like liver and skeletal muscle. Recent~     evidence indicates that the GH-IGF1 axis affects body composition via regulating~     mitochondrial oxidation capacity.~      Thus, excessive GH secretion by a pituitary adenoma (Acromegaly) might be accompanied by~     increased mitochondrial activity leading to inappropriately low intracellular lipid depots,~     especially in metabolically active tissue like liver and skeletal muscle.~      This study aims to assess metabolic activity and intracellular lipid content in skeletal~     muscle and liver in patients suffering from acromegaly compared to controls by 31P/1H~     Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12 months~     after initiation of GH lowering treatments including surgery, somatostatinanalogs or~     pegvisomant, as well as oral glucose tolerance tests at each examination to assess treatment~     responses and calculate validated parameters for insulin sensitivity and resistance.~   "
71927|NCT02115893|"~     The main aim of the current study will be to find the optimal duration of supplementation to~     enhance sports performance.~   "
71928|NCT02115880|"~     The purpose of this randomised controlled trial is to see whether a group-based~     psychological intervention for families can reduce the inflated risk of depression in~     children and adolescents who have at least one parent who suffers from depression (or who~     has suffered from depressed in the child's lifetime).~   "
71929|NCT02115867|"~     Diverticulitis is an extremely common digestive disease particularly found in the large~     intestine in elderly patients and develops from diverticulosis. Diverticulosis is~     characterized by the formation of pouches (diverticula) that bulge to the outside of the~     colon, through areas of weakness in the colonic wall. Inflammation (diverticulitis) results~     if one of these diverticula becomes infected and / or obstructed. It is commonly accompanied~     by obvious or microscopic perforation, ranging in severity from a single, mild, acute attack~     of diverticulitis to more severe attacks characterized by abscess formation, occasionally~     resulting in chronic complications such as obstruction and fistula formation. After an~     episode of diverticulitis many patients develop changes in bowel openings, from diarrhoea~     and constipation, and many patients have abdominal pain and a symptom complex that resembles~     Irritable Bowel Syndrome (IBS).~      According to available guidelines, treatment of symptomatic, but uncomplicated, diverticular~     disease aims to reduce the frequency and severity of diverticular related symptoms~     (abdominal pain, bloating, alterations in bowel habit) and to prevent complications.~     Different agents have been proposed, such as bulking agents, antispasmodics, and nonabsorbed~     topical antibiotics, 5amino acid preparations but these measures are unproven or~     controversial. It is thought that intestinal bacteria may play a significant role in the~     symptoms of post-diverticulitis.~      The investigators have recently shown that a probiotic (Symprove) reduced the symptoms of~     IBS significantly in comparison with a placebo in a double-blind randomized trial and~     without side effects (paper in preparation). Because the symptoms in IBS and~     post-diverticulitis are so similar the investigators propose a double-blind placebo~     controlled trial of Symprove in patients with problematic diverticulitis. Patients will be~     recruited from a dedicated diverticulitis clinic using standard exclusion criteria. This is~     a 90 day symptom based trial using accepted outcome measures. If successful the results will~     have widespread implications for treatment of diverticular disease.~   "
71930|NCT02115854|"~     The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis~     requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease~     successfully treated with high dose steroids is not straightforward and may delay the~     treatment choice by the physician.~      The goal was to evaluate prospectively and consecutively the presence of epithelioid~     granulomas in salivary glands biopsy of patients with TB.~   "
71931|NCT02115841|"~     Noninvasive brain stimulation was recently gradually be emphasized. The electrical current~     applied on scalp can effective modulate cortical excitability. Forms of Stimulation included~     transcranial direct current stimulation(tDCS) and transcranial alternating~     stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The~     polarization effect of direct current stimulation can modulation specific brain area and~     enhance motor performance. tACS was still controversial about the effect on cortical~     excitability. Previous study show that the frequency dependent excitatory or inhibitory~     effect on cortex. The possible mechanism was to affect brain oscillation status by provided~     different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used~     on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory~     evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.~   "
71932|NCT02115828|"~     This is a single-arm pharmacodynamic study with mandatory metastatic tumor biopsies in men~     with castration-resistant prostate cancer.~      The trial will evaluate the effect of vismodegib on tumor tissue in men with metastatic CRPC~     by obtaining tumor biopsies at baseline and after 4 weeks of treatment with vismodegib.~   "
71933|NCT02115815|"~     The purpose of this study is to determine if the administration of single ascending~     intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in~     adults 60 years or older who are healthy or who have stable, chronic underlying medical~     conditions.~   "
71934|NCT02115802|"~     The purpose of this study is to record electrical brain activity during DBS surgery and~     after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a~     modified DBS pulse generator. The goal of the study is to investigate if the electrical~     brain activity can help customize DBS therapy.~   "
71935|NCT02115789|"~     Surgical wounds can be closed in several manners. Some physicians believe that closure in a~     straight line produces a scar that is more visible and slightly raised when compared to~     closure in a zigzagging fashion. The researchers of this study believe that there is no~     difference in the cosmetic appearance of one type of wound closure over the other. To~     evaluate this, they will provide a survey with visual aids to volunteers to rate the~     appearance of a straight line scar versus a zigzag scar.~   "
71937|NCT02115763|"~     Caffeine has been shown to consistently improve time-trial performance, warranting~     restrictions on consumption under regulation of the National Collegiate Athletics~     Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well~     understood, possibly occurring as a result of altered metabolism, improved strength, and/or~     reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor~     while muscular strength has a tenuous relationship with endurance exercise performance.~     Reductions in muscle pain have been observed during low and moderate intensity endurance~     exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing~     pain during high intensity exercise, caffeine significantly improves performance. Therefore,~     caffeine appears to improve the amount of work that can be done for a given muscle pain~     rating, suggesting that participants may pace based upon sensations of muscle pain during~     endurance exercise. Most time-trial exercise is conducted in a fixed distance manner,~     measuring the time it takes participants to cover a given distance. Little research has been~     conducted on a fixed pain time-trial that would require participants to produce and sustain~     a given level of muscle pain while measuring the distance covered in an allotted time. A~     fixed pain time-trial could allow researchers to better understand the effect of pain on~     endurance performance. The purpose of this study is to examine the effects of caffeine on a~     fixed pain time-trial.~   "
71938|NCT02115750|"~     This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid~     arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic~     therapies.~      Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center~     global study. The primary end point is 20% improvement in American College of Rheumatology~     criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.~      Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response~     receive CHS-0214. Continued response and safety will be evaluated.~   "
71939|NCT02115737|"~     Youth with depressive symptoms are at risk for a range of problems later in life. This~     includes problematic interpersonal relationships, occupational stress, and the occurrence of~     adult mental disorders. The main purpose of this study is to test how effective two types of~     group therapy are at reducing depressive symptoms in youth. A focus on group therapy is~     important because group therapy allows for many youth to be treated in a short amount of~     time. Group therapy is also helpful because youth can get social support and feel less alone~     in their symptoms when they participate in group. This study compares two groups, one that~     targets skills for managing difficult emotional experiences (dialectical behavior therapy~     skills group) and another group focuses on psychoeducation and is based on a publicly~     available treatment manual from the Services for Teens At Risk (STAR) Center at the~     University of Pittsburgh. The results of this study will provide insights regarding the~     comparative efficacy of these two treatments, and regarding predictors of treatment~     response.~   "
71940|NCT02115724|"~     Cardiovascular disease is the leading cause of death in the United States. Other studies~     have shown that stress, early in life, could be a risk factor for cardiovascular disease,~     later in life. This study will look at the effect of early life stressors on your~     cardiovascular health.~   "
71941|NCT02115711|"~     The study is a 2 year community based cluster randomized controlled trial to assess the role~     that a community health worker led intervention, in concert with physician education, can~     play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco~     use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include~     around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola,~     Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community~     health worker based approach can result in increased control of Hypertension, Diabetes and~     Smoking.~   "
71942|NCT02115698|"~     Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They~     will be recruited as a subgroup to protocol ID: H-4-2013-070.~      Upon inclusion, each individual will be randomized into one of the five groups stratified~     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy~     Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein~     Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the~     supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to~     the supplement content.~      Assessments will be performed at Baseline (before intervention start) and after 12 months of~     intervention.~      The primary outcomes are measures of muscle protein synthesis rate measured as the~     fractional synthesis rate from Baseline to 12 months of intervention.~      The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are~     elevated in the exercise training groups after 12 months of intervention. ii) prolonged~     intake of protein of different quality will improve the muscle protein synthetic response to~     protein intake after 12 months of intervention.~   "
71943|NCT02115685|"~     Significance: The long term objective of this study is to improve physical therapy and~     fitness programs in people with spinal cord injury. The results of the study will~     demonstrate the importance of matching blood flow to a muscle with exercise of that same~     muscle.~      Scientific Objective: The objective of the study is to measure how the body regulates~     bloodflow to a muscle during exercise. We intend to study these effects by triggering blood~     flow changes during movement, and measuring bloodflow changes during exercise in people with~     spinal cord injury. We will also look at the long term effects of different exercise~     programs on bloodflow during exercise.~      Study Populations: This study will involve people with partial spinal cord injury and age~     and sex matched controls without injury.~      Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the~     injury). This aim will examine the control of bloodflow and muscle contractions and how it~     changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during~     exercise after training. Three different eight week exercise training programs will be~     tested including 1) upper body ergometry, 2) treadmill training with exertion level matched~     to the upper body ergometry and 3) treadmill training with heart rate matched to an initial~     test of upper body ergometry.~   "
71944|NCT02115672|"~     The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in~     improving the response to imatinib in CML patients not achieving an optimal response with~     imatinib alone.~   "
71947|NCT02115620|"~     The purpose of this study is to see if telemedicine can help improve the health of patients~     with heart failure who have recently been hospitalized with heart problems, and are being~     discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to~     make patient/doctor visits possible from a distance.~      This study will use remote video to allow heart failure specialists at Providence St.~     Vincent Medical Center to provide clinical health care to patients at Marquis Hills.~     Electronic monitors (including an electronic scale and blood pressure machine), and phone~     calls with the Marquis Hill nursing staff will be used to track patients' health status. The~     nursing staff will provide the heart failure specialists with daily updates on patients'~     symptoms, weight, vital signs (heart rate, blood pressure, pulse), and results of blood~     tests.~      Additionally, some patients will be provided with monitoring devices that include an iPhone~     blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer~     measures weight, body fat percentage, and heart rate. It also measures indoor air quality.~     Special software on the iPhone will save this information and the information will be~     transmitted by secure email to the study doctors.~      Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency~     Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific~     average for this patient population.~   "
71948|NCT02115607|"~     This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques,~     quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE),~     used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging,~     Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and~     interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant~     chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the~     neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant~     chemotherapy treatment. Results will be compared to MRI and pathology.~   "
71949|NCT02115594|"~     Preclinical data has demonstrated that entinostat (SNDX-275) can enhance fulvestrant~     sensitivity in hormone receptor-positive breast cancer in animal models. The addition of~     entinostat to fulvestrant will provide clinical benefit to patients with locally advanced or~     metastatic breast when compared to fulvestrant plus placebo. Also, based on previous data,~     patients exposed to entinostat who demonstrate an elevated level of protein lysine~     acetylation will have an improved efficacy outcome.~   "
71950|NCT02115581|"~     This study aims to determine the effect of Coenzyme Q10 supplementation on conventional~     therapy of children with heart failure due to idiopathic dilated cardiomyopathy.~   "
71951|NCT02115568|"~     This is an exploratory registry that will include subjects who have been randomized to~     receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of~     delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas~     clinical trial.~   "
71952|NCT02115555|"~     The study will compare three treatment strategies to look at the best clinical outcomes.~      The investigator hypothesizes that the combined approach of a health information technology~     program plus a conflict-management contract will lead to the best outcomes.~   "
71953|NCT02115542|"~     The main purpose of this study is to see if regorafenib can help control or decrease cancer~     size in patients with cancer of the bile duct. Researchers also want to find out if~     regorafenib is safe and tolerable.~   "
71954|NCT02115529|"~     Untreated, one third of patients undergoing general anesthesia will have postoperative~     nausea, vomiting, or both.~      Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative~     pain. PONV increases the risk of aspiration and has been associated with suture dehiscence,~     esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently~     delays discharge, and is the leading cause of unexpected hospital admission after planned~     ambulatory surgery.~      Nabilone (Cesamet®) is a synthetic cannabinoid developed in the 1970s which is a potent CB1~     agonist. The use of nabilone in preventing nausea and vomiting in patients receiving~     chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated~     the efficacy, safety, and tolerability of Cesamet in this population. There has been success~     in the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT~     receptor agonists including Ondansetron and Granisetron) to use in the perioperative~     environment.~      Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995,~     this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given~     90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women.~     This study failed to show any significant difference between groups. There are several~     limitations to this study including a poorly optimized dosing regimen, a small sample size,~     and a comparison group lacking clinical generalizability.~      This study will investigate the use Cesamet vs Placebo, in addition to the regular~     antiemetic treatment which patients receive at the discretion of the managing~     anesthesiologist, for the prevention of PONV. The study group will include patients~     undergoing general anesthesia for elective ambulatory surgery with at least 3 risk factors~     (>60% risk) for the development of PONV.~   "
71955|NCT02115516|"~     TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ~     Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled~     human malaria infection (CHMI).~   "
71956|NCT02115503|"~     The purpose of this treatment registry study is to determine if monthly infusions of~     Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies~     that are thought to be responsible for chronic rejection episodes in renal transplant~     subjects. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months~     and be followed for 3 years.~   "
71957|NCT02115490|"~     Osteoporosis is a public health problem. It is a skeletal disease being treated by~     Bisphosphonates as the first choice medication. The effects of these drugs were investigated~     for periodontal disease treatment both locally and systemically. However, it is very~     important to know their indirect effects on alveolar bone (i.e. their effects when used for~     treating osteoporosis). So, in this study, alternations that involve the alveolar bone when~     osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and~     digital panoramic radiography. The goal is to provide dentists with information about~     changes in the characterization of the alveolar bone among these women. This is important~     for both periodontology and implantology. Maxillary and mandibular bone structural~     characterization among osteoporotic women had not been studied before. Furthermore, in an~     opposite direction, dental radiographs may aid in detecting osteoporosis.~      Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in~     this study. In addition, osteopenic and normal women regarding bone fragility will be~     included too, for comparison purposes. Panoramic radiographs will be taken. In addition,~     women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can~     give an idea about bone histomorphometry with a low radiation dose.~   "
71958|NCT02115477|"~     The purposes of this study are~        -  to determine the prevalence, size and impact on quality of life of lymphedema of the~          lower extremities after primary radical surgery with hysterectomy +/- pelvic - and~          paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO~          (International Federation of Gynecology and Obstetrics) stage 1 and 2~        -  to analyze risk factors for development of lymphedema in this specific group of~          patients.~      Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema,~     subjectively and objectively, and have an impaired quality of life.~      This is a Swedish multicenter study carried out in 17 departments of Obstetrics and~     Gynecology and in 3 departments of Oncology. All participants are treated according to the~     Swedish National Guidelines for Endometrial Cancer.~      130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk~     endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy~     without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the~     study.~      The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6~     weeks , 6 months and 12 months postoperatively.~      Determination of occurrence of lymphedema of the lower extremities are determined~     objectively by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2)~     determining the leg volume according to the cone model by Sitzia [2] by systematically~     measuring of leg circumferences. In addition, occurrence of lymphedema is measured~     subjectively by the participants.~      On the same four occasions as the leg circumference measurements are conducted the patients~     complete two generic health related quality of life forms (the EuroQol EQ-5D and the~     Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema~     (LYMQOL).~      Demographic and clinical data are systematically collected until one year postoperatively~     including occurrence of complications and given adjuvant oncological therapy such as chemo-~     and radiation therapy.~      On each occasion of clinical control a vaginal ultrasound examination is carried out in~     order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion~     intraabdominally.~   "
71959|NCT02115464|"~     ALMERA is a randomized, phase II, open label study in patients with locally advanced~     non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent~     chemotherapy versus the same treatment plus concurrent Metformin continuing for 12 months.~     Metformin is a well tolerated and inexpensive drug that has the potential to improve cancer~     patient outcomes.~   "
71960|NCT02115451|"~     The aim of this study is to evaluate knee function, sports participation and knee reinjuries~     over 2 years in a group of patients who choose either nonsurgical or surgical treatment for~     an anterior cruciate ligament (ACL) injury~   "
71961|NCT02115438|"~     Occupation stress can be the risk factors of early embryonic death~   "
71962|NCT02115425|"~     The purpose of this study is to collect body composition data using bioimpedance analysis~     (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section~     5 of this consent. The data collected will help Samsung improve the products the company~     offers.~   "
71963|NCT02115412|"~     Research has shown that nearly 50% of patients with chronic conditions around the globe do~     not adhere to their prescribed medicine, leading to enormous cost to the healthcare~     providers. Non-adherence can be due to various forms and have multiple causes.~      To address this need, Philips Research has developed Medication Non-adherence model. This~     tool will help in developing a systemic way of assessing medication non-adherence and~     providing decision support for targeted intervention to healthcare professionals. The aim of~     this study is to validate this model with 750 chronically ill patients in UK.~   "
71964|NCT02115399|"~     The purpose of this study is to look at how defects in the skin barrier and immune response~     affect risk for skin infections.~      Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic~     (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive):~        -  AD S. aureus negative~        -  AD S. aureus positive~        -  NA S. aureus negative and~        -  NA S. aureus positive.~   "
71965|NCT02115386|"~     Primary Objective for this study is to evaluate changes in chronic low grade~     non-hematological adverse events experienced by patients who have been treated with at least~     6 months of imatinib and who have not responded to supportive measures, when they are~     switched to nilotinib (CTCAE grading system).~   "
71966|NCT02115373|"~     This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and~     pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced~     hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed~     sorafenib treatment.~   "
71967|NCT02115360|"~     A prospective randomized double-blind clinical trial design will be used in a cohort of~     sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA)~     I and II who will undergo lower limb amputation, will be enrolled into the present study.~     Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and~     fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.~   "
71968|NCT02115347|"~     This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835,~     PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1~     of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and~     matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be~     conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).~   "
71969|NCT02115334|"~     Early intervention refers to the provision of early detection, early diagnosis, and early~     intervention for infants and young children with special needs. The implementation of home~     programs is very important for children with developmental delay (DD). Therefore, the~     purposes of this study are to: (1) design the preschool home program activities(PHPA), (2)~     investigate the immediate efficacy of PHPA for children with DD, (3) investigate the~     long-term efficacy of PHPA for children with DD.The second year is to investigate the~     immediate efficacy of PHPA for children with DD.~   "
71970|NCT02115321|"~     This study is being done to evaluate the efficacy and safety of the drug combination~     grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis~     C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP)~     score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the~     percentage of HCV-infected participants with hepatic insufficiency (the CP-B population)~     achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12)~     will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants~     will also be given GZR + EBR at the beginning of the study; this will be done for the~     purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who~     do not have hepatic insufficiency.~   "
71971|NCT02115308|"~     The purpose of this study is to measure the changes in cardiac function during a Lexiscan~     pharmacologic stress test using cardiac magnetic resonance imaging test.~   "
71972|NCT02115295|"~     The goal of this clinical research study is to learn if the combination of cladribine,~     idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast~     phase. The safety of these drugs will also be studied.~   "
71973|NCT02115282|"~     This randomized phase III trial studies exemestane and entinostat to see how well they work~     compared to exemestane alone in treating patients with hormone receptor-positive breast~     cancer that has spread to nearby tissue or lymph nodes or another place in the body.~     Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may~     fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known whether exemestane is more effective with or without entinostat in treating breast~     cancer.~   "
71974|NCT02115269|"~     Headaches are a common medical problem that physicians frequently encounter in their~     practice. One of key findings of The Atlas of Headache Disorders prepared by World Health~     Organization (WHO) is: headache disorders, including migraine and tension-type headache~     (TTH), are among the most prevalent disorders of mankind. The fixed combination of~     indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute~     treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is~     widely used in common daily practice only in Italy from early 1970s, is available at the~     Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data~     regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing~     observational study which aimed to evaluate the effectiveness and patients' satisfaction of~     primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.~   "
71975|NCT02115256|"~     Breech presentation of a term pregnancy is a common occurrence. A procedure known as~     external cephalic version (ECV) is frequently used by obstetricians to turn the baby into~     the vertex position prior to delivery in order to avoid a cesarean section and the~     associated risks. Medications to relax the uterus, known as tocolytics, are used in~     conjunction with the procedure as they have been shown to improve the success rate of ECV,~     but with inconsistent, varying results.~   "
71976|NCT02115243|"~     The purpose of this study is to determine safety profile, initial response rates and~     progression free survival for the combination therapy of neoadjuvant system ipilimumab~     followed by ILI with melphalan in patients with in transit melanoma.~      Hypothesis:~      The combination of regional LPAm plus systemic ipilimumab will lead to a larger response~     rate than either therapy alone.~      The combination of regional LPAm plus systemic ipilimumab will cause larger changes in~     immune cell populations than are seen with either therapy along.~      Changes in immune cell populations will predict progression free survival.~   "
71977|NCT02115230|"~     It is a randomized prospective controlled study of transcatheter renal denervation in~     patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to~     evaluate the safety and effectiveness of renal denervation in patients with Heart Failure~     With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic~     activity.~   "
71978|NCT02115217|"~     Ankles sprains are the most popular injuries in basketball players. They are traumatic~     injuries, which happen most of the time in specific situations, like landing on another~     player's foot, or during changes of direction.~      Neuromuscular exercises are very important to improve ankle stability and reduce risks of~     sprains. However various external support such as ankles braces and rigid tape, are also~     used in order to prevent injury.~      The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by~     KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today~     commonly used during practices and/or competitions. The main property of this tape is its~     elasticity, which is supposed to improve proprioception and, thus ankle stability, but these~     aspects have not been investigated yet.~   "
71979|NCT02115204|"~     Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer~     (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West~     German Study Group and Arbeitsgemeinschaft Gynäkologische Onkologie (WSG-AGO) EC-Doc is a~     large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3~     involved lymph nodes (LN).~   "
71980|NCT02115191|"~     Urethrocutaneous fistulae (UCF) represent one of the most frequent causes of morbidity after~     urethroplasty. Hypospadias can be repaired using different surgical techniques, but~     regardless of technique, the incidence of UCF ranges between 10% and 40%. The surgical~     repair of UCF remains the treatment of choice, even if some patients need further operations~     because of recurrences. The cyanoacrylates have been used as skin suture substitutes, and~     some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in~     the management of UCF.~   "
71981|NCT02115178|"~     Background and Goal of Study: Minimal dose of spinal hyperbaric bupivacaine is commonly~     performed for adult anorectal surgery. This kind of anaesthesia can cause sinus bradycardia~     and hypotension wich reason is body position, autonomic nervus system reaction, reflex~     reaction even with low levels of sensory block. However, neither the publication of minimal~     doses of spinal hyperbaric bupivacaine effects of haemodynamic modifications nor their~     accuracy was widely discussed. The aim of the study is to make a comparison of the~     haemodynamic modifications due to minimal dose of spinal hyperbaric bupivacaine for adult~     anorectal surgery in lithotomy or jack knife position of steering impedance device.~      Materials and Methods: Patients will be included which are over then 18 years old, who~     underwent anorectal surgery of the benign pathology, requiring spinal anaesthesia, were~     admitted in this clinical randomized study, hospitalized in Hospital of Lithuanian~     University of Health Sciences Kaunas Clinics and agree to participate to this study (written~     settlement). All patients were implicitly divided in to 4 groups by the position will be~     operating (lithotomy or jack knife position and by American Society of Anaesthesiologists~     (ASA) clas I-II and III-IV). Technique of anaesthesia were strictly standardized by~     protocol. All patients were premedicated with oral diazepam 5mg and diclofenac 100mg 60min~     before operation. After arrival in the operating theater peripheral vein 18 or 20G catheter~     was inserted, infusion therapy were started with crystalloid 5-7ml/kg/hour. Standard~     monitoring was used, including noninvasive arterial blood pressure (BP), electrocardiography~     (ECG), heart rate, peripheral oxygenation. Circulatory changes were recorded impedance~     device. 2 single-neck sensors connected vertically on both sides of the neck just below the~     ears lobe. Another pair of sensors attached on both sides of the chest processus xiphoid~     axillary line level. Thorax allows a variable electrical current, it travels through the~     lowest resistance (blood-filled aorta) and resistance is measured. For each heart~     contraction during changes in blood volume and velocity. Accordingly, replacing the~     resistors obtained by impedance settings.~      Haemodynamic variables were recorded in patients in the use of impedance cardiograph:~        1. arrives in the operating room;~        2. seating on the operating table;~        3. following the puncture;~        4. 10 min after spinal puncture;~        5. was laid in lithotomy or jack knife position;~        6. in the beginning and the end of the operation;~        7. patient was placed in the bed.~      Each measurement was monitoring and recorded the following data( ar findings):~        -  Cardiac output (CO);~        -  Systemic vascular resistance (SVR);~        -  Systolic index (SI)~        -  Cardiac index (CI);~        -  Acceleration index (ACI);~        -  Heart rate (HR);~        -  Non-invasive systolic (SAP), diastolic (DAP) and mean (MAP) blood pressure;~        -  Peripheral oxygenation (SpO2); Patients were placed in the sitting position on the slab~          (operating table) back to the doctor. Dural puncture was made at L3-L4 or L4-L5 with~          27G Tamanho spinal needle ( BBraun, Germany) by medial punction in aseptic condition,~          before the punction was injected lidocaine 1% subcutaneous. 0.5% 4mg of heavy~          bupivacaine and 0.01% 10µg fentanyl were injected over 2 minutes after free flow of~          cerebrospinal fluid was obtained. After sitting for 10 minutes ( sensory block was~          checked by the dermatomes with the methods of cold sensitivity) patients were asked to~          lie in the position wich operation will be done (lithotomy or jack knife position).~      After 20 min. surgery was started. When anaesthesia was imperfect, 25-100µg of fentanyl was~     given IV. General anaesthesia will be give in case of failure . These cases will be value~     like a failure, patients will be exclude from the study.~      Clinically significant hypotension will be define as a mean arterial blood pressure and~     heart rate decrease of 20% below baseline values. Systolic arterial blood pressure will~     reduce to 90mmHG limit, intravenous ephedrine 5-10 mg will be injected. If heart rate will~     reduce to 45 bpm, bradycardia will be treated with atropine 0,5 mg IV.~   "
71982|NCT02115165|"~     Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing~     and limited peripheral neuro-toxicity, two major potential advantages in patients with~     advanced NSGCTs.~      Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have~     demonstrated activity in pre-treated GCTs and are now part of standard treatment, but~     cabazitaxel has not yet been tested in patients with NSGCT.~   "
71983|NCT02115152|"~     This randomized phase II trial compared pathologic response rates (pCR) of early breast~     cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and~     capecitabine-epirubicin-cyclophosphamide (XEC).~   "
71994|NCT02115009|"~     The overall goal of this study is to characterize the SIJ form, function, nerve entrapments,~     lumbo-pelvic configuration and their possible relationships with nonspecific chronic LBP in~     females and males. Specific aims: 1.To investigate the relationship between SIJ bridging and~     NSCLBP in females and males. 2. To investigate the prevalence and characterization of nerve~     entrapment of the lumbar sacral plexus around the SIJ in females and males. 3. To~     investigate the correlation between the lumbar sacral plexus nerve entrapments around the~     SIJ and NSCLBP in females and males. 4. To investigate the relationship between the lumbar~     sacral plexus nerve entrapments around the SIJ and lumbo-pelvic morphology in females and~     males. 5. To characterize the location and severity of articular degenerative changes in the~     SIJ and its relationship with lumbo-pelvic morphology in females and males. 6. To~     investigate the relationship between articular degenerative changes in the SIJ and LBP in~     females and males.~   "
71995|NCT02114996|"~     Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical~     ventilation.~      The study will include 30 patients on mechanical ventilation that will be intervened by the~     vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.~   "
71984|NCT02115139|"~     Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic~     to the brain.~      Melanoma is the third most common cancer causing brain metastases, after cancers of the lung~     and breast, which appears to reflect the relative propensity of melanoma to metastasize to~     the central nervous system (CNS). Brain metastases are responsible for 20 to 54 percent of~     deaths in patients with melanoma, and among those with documented brain metastases, these~     lesions contribute to death in up to 95 percent of cases, with an estimated median overall~     survival ranging between 1.8 and 10.5 months, depending upon other prognostic factors.~      Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) monoclonal antibody that~     has demonstrated a clinically relevant and statistically significant improvement in overall~     survival, either alone (second line) or in combination with dacarbazine (DTIC) in 1st line.~      Ipilimumab has shown activity against brain metastases.~      According to the European Medicines Agency (EMA) approved label for Yervoy®, the use of~     glucocorticoids at baseline (commonly prescribed when brain metastases are diagnosed) should~     be avoided before the administration of ipilimumab. Data show that the use of even high~     doses of glucocorticoids for the management of immune-related adverse events do not decrease~     the efficacy of Yervoy®. There is no documented experience on the efficacy of Yervoy® when~     given concomitantly with radiation therapy and glucocorticoids.~      In experimental models, radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte~     Antigen 4 (anti-CTLA4) strategies (abscopal effect).~      There are no published results from clinical trials on the interaction between radiation~     therapy and ipilimumab.~   "
71985|NCT02115126|"~     This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to~     evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor~     antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or~     co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the~     setting of autologous stem cell transplant with infusion of mature T cells. Patients will be~     randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand,~     DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and~     non-Hodgkin lymphoma.~   "
71986|NCT02115113|"~     The purpose of this study is, starting from the Italian clinical practice in liver~     transplantation, to optimize the immunosuppressive therapy, considering specific patient~     characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma~     (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor~     (CNI)-withdrawal regimen will be evaluated in comparison with a CNI-minimization regimen.~   "
71987|NCT02115100|"~     Prospective, randomized, controlled, multicenter, international clinical trial. The study~     population consist of patients with paroxysmal or persistent atrial fibrillation with out~     range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of~     the following two groups.~      group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo~     pulmonary vein isolation and renal artery denervation.~   "
71988|NCT02115087|"~     The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block~     (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.~   "
71989|NCT02115074|"~     Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a~     secondary role. Unlike other sites, many of these tumors are not amenable to complete~     resection either because of anatomical location, and sometimes they only can be biopsied. A~     substantial number of children will have recurrences following resection or will experience~     progression following incomplete tumor removal or biopsy.~      Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins~     are known to increase the sensitivity of gliomas to anti-tumor agents. Their association~     could be administered for long periods, in the hope of much reduced risk of toxicities.~      This is a national, multicentric, interventional, open-label, non-comparative, and~     non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in~     combination with fixed-dose of Celebrex.~      This project involves 10 SFCE health centers accustomed to phase I / II studies(Société~     Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French~     Society for the Fight against Cancer and Leukemia in Children and Adolescents).~   "
71990|NCT02115061|"~     The purpose of the spring is to maintain the cyanoacrylate polymer of the gastric varix,~     forming a conglomerate spring-cyanoacrylate, and thus preventing their migration to the~     adhesive embolism.~      The introduction of the spring is held by a echo-guided puncture. The window can be puncture~     through the distal esophagus or directly in the gastric varix via retroflexion to the~     fundus. Another advantage of this technique is its use in the presence of bleeding, when~     large amounts of blood in the stomach hinders the injection of the cyanoacrylate, by~     pricking the distal esophagus that difficulty decreases. The first study of this technique~     was performed by Binmoeller et al (21) and had good results with 100% hemostasis and low~     rebleeding rate (16%), but more studies are needed to prove the safety and efficacy of this~     technique.~   "
71991|NCT02115048|"~     The purpose of the study is to compare the efficacy of treatment with afatinib plus~     letrozole to treatment with letrozole alone in women diagnosed with a specific type of~     breast cancer.~   "
71992|NCT02115035|"~     The objective is to evaluate the overall response rate of Vermurafenib when administered~     orally to patients with relapsed or refractory multiple myeloma.~   "
71993|NCT02115022|"~     Accurate staging of patients with pancreatic cancer is critical to avoid the expense,~     morbidity, and mortality related to unnecessary surgery. While several tests are available~     for assessing such patients, consensus has not been achieved on the optimal approach. As a~     matter of fact, pancreatic cancer staging is discussed controversially due to conflicting~     evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the~     role of EUS and EUS-guided FNA varies among treatment centers.~      The present study is designed to better define the role of EUS in predicting resectability,~     as compared to high resolution cross-sectional imaging.~   "
72019|NCT02114684|"~     This is an open label randomized controlled clinical trial comparing two regimens for~     treatment of smear-positive pulmonary TB, among patients previously treated for TB. The~     primary objective is to determine if a moxifloxacin-containing regimen, substituting~     moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24~     weeks duration in improving treatment outcomes in patients with recurrent TB and shortens~     the duration of TB treatment.~   "
71996|NCT02114983|"~     Numerous studies have demonstrated excellent diagnostic accuracy of Compression~     Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.~      Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners~     (GP) can perform reliable ultrasound to increase the speed and improve the quality of~     clinical management of various clinical conditions. To date, in the medical literature there~     are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the~     diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective,~     multicenter, cohort study in which a large number of consecutive outpatients with symptoms~     or signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision~     and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this~     case will be the standard of reference.~   "
71997|NCT02114970|"~     The investigators will develop and test a tablet-delivered informed consent process. In a~     preliminary phase of the study, older adults will provide feedback on a prototype~     tablet-delivered consent by participating in a focus group. In a separate second phase,~     older adults will be randomly assigned to a tablet-delivered or paper-delivered consent~     condition in which their comprehension of material covered in the consent will be assessed.~   "
71998|NCT02114957|"~     This study is to investigate how human bodies absorb and metabolize two herbal drugs. The~     information is critical for drug development and could not be obtained from any other~     studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which~     naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical~     studies indicated that AGN and decursin/DA were quite safe to animals and human.~   "
71999|NCT02114944|"~     Patients with severe chronic diseases are often admitted to the hospital complaining of~     shortness of breath. Some of these patients decide that they do not want placement of a~     breathing tube in the windpipe to assist their breathing. In this situation, these patients~     are treated with oxygen, a variety of medications like morphine or masks that are connected~     to breathing machines, something called bilevel positive airway pressure (BiPAP) or~     noninvasive ventilation (NIV), to help with their breathing. Not much is known about how~     much noninvasive ventilation helps these patients, especially how comfortable they feel with~     it and how much their families think it helps.~      Our aim is to monitor use of ways to help breathing in patients who don't want a breathing~     tube, see how often noninvasive ventilation is used and ask surviving patients, patient's~     families and caregivers about their experience with noninvasive ventilation and how much it~     seemed to help.~      With our findings, we hope to improve the use of noninvasive ventilation in these patients~     and come up with ways to relieve their shortness of breath and provide as much comfort as~     possible.~   "
72000|NCT02114931|"~     The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP~     501.~   "
72001|NCT02114918|"~     Voluntary and involuntary attention processes are thought to play an important role in the~     development and maintenance of anxiety disorders including OCD. Individuals with OCD pay~     greater attention to threat information related to their illness and have difficulty~     shifting their attention from such triggers. Studies suggest that a change in attention bias~     may lead to a change in anxiety vulnerability. However, few studies have directly examined~     the causal role of attention bias in the maintenance of anxiety underlying OCD and whether~     modification of such biases may reduce pathological anxiety symptoms particularly in~     children. In this proposal, we aim to translate basic findings from research on cognitive~     biases in anxiety into a novel computerized intervention for child Obsessive Compulsive~     Disorder (OCD). The treatment is designed to target a basic cognitive vulnerability in OCD,~     namely the selective processing of threatening OCD-related information. 52 children with OCD~     will be randomly assigned to either a 12-session attention modification program (AMP) or an~     attention control condition (ACC). Clinical assessment of symptom severity along with a~     brief neurocognitive battery will be conducted before and after treatment. We hypothesize~     that children in the AMP group at end of treatment will show (1) decreased attention bias to~     OCD-related triggers using an independent measure of attention bias to assess change and (b)~     reduced OCD severity. This study is an initial step towards demonstrating the feasibility~     and efficacy of a novel computerized attention training program for OCD that ultimately may~     prove to be a highly transportable and accessible intervention for this childhood~     psychiatric disorder. Furthermore, the project will also examine neurocognitive performance~     before and after attention training to elucidate possible predictors and mechanisms of~     treatment response.~   "
72002|NCT02114905|"~     Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for~     tic disorders. A recent scientific review of research priorities completed by the Tourette~     Syndrome Association recommended widespread dissemination of CBIT as an important next step~     in services delivery research. Given early evidence that occupational therapists can deliver~     CBIT effectively, a dissemination strategy using occupational therapists may improve~     accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of~     this study is to develop and test a training and dissemination model with occupational~     therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York~     Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The~     investigators have adapted CBIT, the gold-standard behavioral intervention program for~     children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across~     the country.~   "
72003|NCT02114892|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's~     also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has~     beneficial effects on glucose and lipids metabolism, blood pressure and body weight.~      The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome,~     insulin sensitivity and insulin secretion.~      The investigators hypothesis was that the administration of resveratrol modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
72004|NCT02114879|"~     The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an~     effective treatment for older adults after disabling medical events.~   "
72005|NCT02114866|"~     Postoperative handovers to the post anaesthesia care unit (PACU) in adult anaesthesia are~     described as incomplete and unstructured, although their relevance for the patient safety is~     well known. It must be assumed that for children, this handover is at least comparable~     important.~      With a self-developed checklist information transfer during postoperative handovers will be~     documented and subsequently compared with patient information in anaesthesia records.~   "
72095|NCT02113696|"~     Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly~     obese patients, will improve the inflammatory status? C-reactive protein? Weight?~   "
86627|NCT01923493|"~     The aim is to evaluate whether tuina is more effective and cost-effective than no~     intervention waiting list to reduce neck pain measured on a visual analogue scale in~     patients suffering from chronic neck pain.~   "
72006|NCT02114853|"~     Sepsis is common in the ICU and is associated with high mortality that reaches up to 60%,~     increased duration of hospitalization and additional costs [1,2].Early diagnosis and~     stratification of severity are of great importance in order to timely apply proper and~     adequate treatment [3].~      Oxidative stress is implicated in inflammation and sepsis and sepsis severity seems to~     correlate with increased oxidative stress [7,8]. Monitoring of oxidative stress has been~     done so far with various markers which reflect the different pathways of oxidative stress as~     is oxidosis of lipids, proteins, nucleic acids; yet the antioxidant capacity of various~     enzymes and vitamins has been studied [9]. However these methods do not reflect oxidative~     stress as a whole, are time consuming, need special laboratory procedures and are costly.~      Oxidation-reduction potential is a new technique that enables bedside assessment of the~     oxidative status. It is based on measuring the balance of oxidants and reductants in human~     blood with a simple plasma test that reports results immediately.~      Hypothesis~      Oxidation-reduction potential, used for oxidative monitoring in ICU patients, might~     correlate with sepsis severity and may be used in addition to other clinical and/or~     inflammatory markers to assess severity and possibly prognosis.~   "
72007|NCT02114840|"~     The purpose of this study is to determine pronator quadrutus preservation have clinical~     impact following volar plate fixation~   "
72008|NCT02114827|"~     Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic~     stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT~     frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at~     the National Institutes of Health (NIH).~   "
72009|NCT02114814|"~     The aim of this study is to compare the efficacy of an intervention and an attention control~     group in producing changes in diabetes self-management, A1C and health related quality of~     life in Hispanics with type 2 diabetes.~      Hypothesis: The experimental group who receive an 8 week intervention program will show~     significantly greater improvements than an attention control group at 1 and 6 months after~     the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy,~     and family support, outcomes of self-reported management of diabetes (physical activity,~     diet, medications, and glucose monitoring), A1C levels, and psychological outcomes of~     health-related quality of life.~   "
72010|NCT02114801|"~     The aim of the present study was to determine the effectiveness of brushing with an electric~     toothbrush switched on and switched off in comparison to manual brushing for the removal of~     dental plaque in children aged four to 16 years with cerebral palsy.~   "
72011|NCT02114788|"~     The aim of the study is to study how to improve patients' management of chronic back pain,~     particularly their management of prescription medication, through increasing health literacy~     and patient empowerment through an internet based intervention. We do this by designing both~     patient education materials and physician communication strategies to increase literacy and~     volitional components of patients. We will test two conditions using a website called~     Oneself: one providing only information (literacy-only control) and a second providing~     relational communications designed to increase both literacy and volitional empowerment. To~     test the self-management enhancing effects of empowerment and health literacy, we will~     conduct a longitudinal experiment with 51 chronich back pain patients over two months. This~     span of time is the minimum necessary to achieve a systematic change in self-management and~     literacy skills, increasing also the range of possible decisions to be made and actions to~     be real-ized by the patients.~   "
72012|NCT02114775|"~     The overall goal is to determine whether perceptual or performance fatigue can be reduced in~     MTBI patients with and without growth hormone (GH) deficiency by treating them in a~     crossover fashion based upon GH status.~      A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed~     to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.~   "
72013|NCT02114762|"~     This study evaluates the usefulness and safety of using a balloon to dilate (make larger)~     the Eustachian tube in adults who have middle-ear disease due to Eustachian tube~     dysfunction.~   "
72014|NCT02114749|"~     This study is aimed to develop analysis methods and measurements tools for physiological~     variables : respiration, circulation and their mutual interactions and with the functions~     involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...).~     The devices that are used are non invasive. The development of these tools needs to be~     validated on physiological signals obtained in healthy volunteers.~   "
72015|NCT02114736|"~     Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff~     knee gait is a frequent condition among stroke patients leading to reduce gait speed and~     increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections~     in the rectus femoris is recommended. However, the botulinum toxin A effect is transient~     necessitating repeated injections.~      The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison~     with botulinum toxin A injections according to the 3 domains of the International~     Classification of Functioning Disability and Health of the World Health Organisation~   "
72016|NCT02114723|"~     Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms~     most frequently described in primary dysmenorrhea.~   "
72017|NCT02114710|"~     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate~     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by~     which little doses of hydrocortisone influence coagulation system in sepsis.~   "
72018|NCT02114697|"~     The goal of this study is to assess a slimy substance that settles/deposits along blood~     vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium~     or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to~     various parts of body. Blood vessels include vessels that supply to heart (coronary),~     vessels to brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral).~     Decreased blood flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly~     individuals at risk of cardiovascular disease can have certain markers elevated in their~     blood that can be measured by simple blood tests.~      High or increased plaque deposition is seen in neck vessels of cancer patients who received~     radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are~     at increased risk of plaque development and are therefore called high-risk population.~     Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins~     are one of the several fat lowering medications.~   "
72020|NCT02114671|"~     To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or~     delayed type, to UV light and visible light in healthy male and female subjects. To~     investigate the degree, wavelength dependency, severity, pigmentation and morphology of the~     phototoxic effects. The persistence of the phototoxic susceptibility will be explored~     following cessation of study medication. Within a sunscreen sub-study, the efficacy of~     commercially available high factor sunscreen will also be assessed in terms of its potential~     to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir~     will also be assessed.~   "
72021|NCT02114658|"~     The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of~     sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or~     locally advanced or metastatic medullary thyroid carcinoma (MTC).~   "
72022|NCT02114645|"~     This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered~     in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and~     GnRH antagonist protocol.~   "
72023|NCT02114632|"~     The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in~     boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group~     healthy boys.~   "
72024|NCT02114619|"~     Radioactive iodine (RAI) administration is an effective and completely established treatment~     modality in hyperthyroidism including Graves' disease. Despite the long experience with~     radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine~     that is required to achieve long-term euthyroidism. The fixed activity administration method~     does not optimize the therapy, giving often too high or too low radiation to the gland, but~     the optimal dose per gram of thyroid mass in calculated activity administration method is~     also under much debates. This prospective study has been designed in order to compare the~     effect of different calculated doses of radioiodine on Graves' disease treatment outcome.~   "
72025|NCT02114606|"~     The current endoscopic methods for diagnosing and monitoring treatment response in~     Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods~     are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to~     be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of~     obtaining a true tissue sample, and our preliminary data supports its further study in EoE.~     The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE,~     will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and~     determine the safety and acceptability of this technique. Use of the Cytosponge would~     fundamentally change the paradigm for clinical management of EoE by allowing collection of~     non-endoscopic esophageal biopsies, thus minimizing the need for invasive testing. It would~     also facilitate future genetic, mechanistic, and pathogenesis research in EoE.~   "
72026|NCT02114593|"~     The aim of this project is to evaluate the effectiveness of a culturally adapted parenting~     support program for Somali parents living in Sweden on children's and parent´s mental~     health. In recent years the Somali population in Sweden has increased and is currently one~     of the largest groups among ethnic minorities. Most of the Somali people have arrived as~     refugees and have experienced war, trauma and conflict. Research shows that migration to a~     new social context/society is challenging for a family and may together with previous~     experiences of war, separation, create stress and mental illness. This leads to consequences~     such as family violence, child abuse, relational problems, drug problems and school problems~     for children. There is a vast knowledge on the association between parents' mental health,~     positive parent-child relationship and children's health and well-being. Previous studies~     have shown that parenting programs aimed to support parent-child relationship and/or improve~     parental skills have positive effects on parental mental health and on children's behavior.~     Most municipalities in Sweden offer their residents a structured parenting program, but~     these programs do not reach those of ethnic minorities. Studies show that parenting programs~     mainly target parents who can speak Swedish fluently and that the parenting programs are not~     yet culturally adapted.~   "
72027|NCT02114580|"~     The proposed study aims to explore brain mechanisms mediating the cognitive benefits of~     aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer~     disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that~     will advance our knowledge about the nature of these mechanisms. Participants will~     participate in individual- tailored aerobic training program. Pre and post evaluation will~     identify brain changes following the training using advanced techniques of brain imaging.~     Cognitive performance will be assessed prior and at the end of the program, as well as~     endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating~     cortical plasticity in subjects with aMCI has tremendous practical significance for these~     subjects .~   "
72028|NCT02114567|"~     Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive~     end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of~     breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level~     compared with pressure-support ventilation (PSV)~   "
72029|NCT02114554|"~     Mitochondrial diseases are multisystem disorders that present with a wide range of clinical~     manifestations. Mitochondrial DNA nt3243A>G mutation is one of the most common mutations~     seen in mitochondrial diseases. Syndromes associated with this mutation include~     mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes (MELAS), maternally~     inherited diabetes and deafness (MIDD), myoclonic epilepsy with ragged red fibers (MERRF),~     and chronic progressive external ophthalmoplegia (CPEO). Clinical analyses of mitochondrial~     DNA nt3243A>G mutation from Taiwan remain scarce. The present study aims to investigate the~     clinical features and prognostic factors of patients with mt3243A>G mutation in Taiwan.~   "
72030|NCT02114541|"~     The relationship of the natural history of atherosclerosis between different vascular beds~     has not been well characterized. Determination and comparison of the relative rates of~     progression and extents of atherosclerosis in the coronary and carotid arterial trees may~     have major impacts on clinical research and clinical practice. Correlation between findings~     in the carotid and coronary circulations is an important scientific and clinical topic to~     address. Results from a well design study incorporating imaging technologies that currently~     represent the gold standards for the assessment of coronary and carotid artery plaque~     burden, will have potentially impact on clinical research and clinical practice.~   "
72031|NCT02114528|"~     The purpose of this study is to determine whether catheter based ablation is better than~     conventional anti-arrhythmic drug (AAD) therapy for reducing recurrent shocks in patients~     with an implantable cardioverter defibrillator (ICD). The second purpose of the study is to~     determine the safety of catheter-based ablation and the effect on quality of life of~     patients.~      The study hypothesis is that catheter ablation is superior to AAD therapy in preventing~     recurrent ventricular arrhythmia in such subjects. This is a pilot trial which will provide~     data regarding recruitment potential and the feasibility of conducting a larger trial.~   "
72032|NCT02114515|"~     Staying out of the hospital is valued by patients and their caregivers. Their interests~     converge with those of hospitals now that high 30-day readmission rates for some conditions~     place hospitals at risk for financial penalties from the Centers for Medicare and Medicaid~     Services. This study focuses on developing and testing a program that combines a community~     health worker (lay patient advocate, acting as a Patient Navigator) and a peer-led~     telephone support line to improve patient experience during hospital to home transition.~   "
72033|NCT02114502|"~     The goal of this clinical research study is to learn if carfilzomib and vorinostat combined~     with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control~     multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of~     this combination.~   "
72034|NCT02114489|"~     Aseptic osteonecrosis of the hip (AOH) concern 1 Swiss young adult to 1000 (30-40 years~     old). They are responsible to a severe joint destruction and in the majority of cases a~     joint replacement. To the hip, we can distinguish 4 stages of osteonecrosis according to~     Ficat: 1, 2, 3, 4. Stage 3 and 4 AOH management are unanimous surgical. But management of~     stage 1 and 2 are unclear. Bisphophonates are mainly used for bone and osteoporosis~     diseases. They decrease the bone turn over, and the risk of fracture. They also decrease the~     bone marrow oedema and the pain associated to this oedema. Ibandronate is a bisphosphonate~     with a rapid effect, a short half-life, easy to manage, and with few side effects. We~     designed a double-blind prospective randomized trial aiming to evaluate the efficacy of an~     infusion of ibandronate versus placebo on pain and AOH progression in patients with stage 1~     and 2 AOH. Our hypothesis is that there will be a pain reduction >=20 mm on the VAS scale~     (SD 10mm) in the ibandronate group versus placebo, and a non radiological progression in the~     treated group.~   "
72035|NCT02114476|"~     The purpose of this study is to determine the effect of implantable contraception on the~     incidence of diabetes mellitus in women with history of gestational diabetes mellitus~     comparing with those using nonhormonal contraceptives.~   "
72036|NCT02114463|"~     Pain after amputation is a significant problem among amputees. Phantom limb pain may appear~     in up to 85% of patients and is usually resistant to a wide variety of treatments.It is~     believed that regional anesthesia, by preventing the establishment of central sensitization,~     may play a role in reducing the incidence of acute and chronic pain. Therefore the~     investigators will compare two methods of postoperative analgesic after after amputation by~     their efficiency and complication.~   "
72037|NCT02114450|"~     This research study will investigate the use of smart lower limb robotic exoskeleton~     (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare~     robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also~     examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain~     wave patterns associated with learning to walk on the powered lower limb exoskeleton. The~     findings will be used to understand human-robot interaction and to design smart orthotic~     devices that can be controlled by thought activity and assist those that have lost all or~     part of their walking abilities.~   "
72038|NCT02114437|"~     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of~     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it~     difficult to judge the depth of anesthesia according to traditional hemodynamics index such~     as heart rate and blood pressure.In case of this, the investigators design this research to~     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided~     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.~   "
72039|NCT02114424|"~     POSAS can be treated with CPAP however there is now evidence from a few studies that Night~     Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we~     would like to examine if we could find similar results in routine clinical work and~     especially we would like to confirm the subjective effects with objective measures i.e. a~     reduction in AHI in the supine position during sleep.~   "
72040|NCT02114411|"~     Background: Atrophic gastritis (AG) is the single most important precursor condition for~     gastric cancer (GC) known so far. H. pylori infection is the most important causative agent~     of gastritis, and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki,~     Finland), a blood test evaluating the four biomarkers specific for the gastric mucosa~     pepsinogen I (P-PGI), pepsinogen II (P-PGII), gastrin-17 (P-G-17) and H. pylori antibody~     (P-HpAb), is the first non-invasive diagnostic tool providing possibilities for detecting~     the patients at risk for GC and peptic ulcer as well as malabsorption of vitamin B12, iron,~     magnesium, calcium and some drugs. A well designed clinical study is warranted to fully~     assess the performance of GastroPanel examination in detecting the gastric lesions which can~     lead to GC. The investigators aim to perform a clinical study in an adult population in~     United Kingdom in order to determine the diagnostic accuracy of the GastroPanel test in~     evaluating AG and other specific gastric conditions associated with an increased risk for~     GC. Methods: Two hundred and fifty patients (45 years and older, both genders) will be~     enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University~     Hospital (London, United Kingdom). During the same visit, all patients are subjected to~     gastroscopy examination, with directed biopsies from the antrum and corpus, following the~     protocol of the operative link on gastritis assessment (OLGA) classification for chronic~     gastritis and Sydney Classification. Biopsies are examined at the Pathology laboratory of~     Homerton University Hospital and interpreted using the OLGA staging system as well as the~     Sydney system for classification of gastritis. Specific aims: The principal goal of this~     clinical trial is to establish the performance of the GastroPanel examination in detecting~     AG and other specific gastric conditions associated with an increased risk for GC. In~     particular, the investigators will evaluate AG in the antrum, AG in the corpus, AG in both~     antrum and corpus (=atrophic pangastritis), biopsy-confirmed dysplasia (intestinal~     metaplasia) of the gastric mucosa. For all these conditions, the investigators will~     calculate the diagnostic accuracy of the GastroPanel test.~   "
72041|NCT02114398|"~     The study aim is to compare usual asthma crisis treatment of hospitalized children with~     usual treatment associated to sophrology.~   "
72042|NCT02114385|"~     Primary objective~      To demonstrate that administration of the 9vHPV vaccine induces non-inferior Geometric Mean~     Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to~     26-year-old men~   "
72043|NCT02114372|"~     The purpose of this study is to investigate the natural history of cognitive and functional~     changes in participants at risk for developing mild cognitive impairment (MCI) due to~     Alzheimer's disease (AD) (MCI-AD).~   "
72044|NCT02114359|"~     The investigators compare the overall survival between combination chemotherapy and~     monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or~     recurrent gastric cancer. The investigators also compare the progression free survival,~     response rate, safety, and, quality of life between two groups, and evaluate that the~     comprehensive geriatric assessment tested at baseline can predict the toxicity and~     compliance of treatment, survival of the patients.~   "
72045|NCT02114346|"~     The aim of this study is to determine the efficacy of atorvastatin in the prevention of~     contrast-induced nephropathy in patients undergoing computed tomography coronary~     angiography. Investigators assume that atorvastatin is effective in this regard.~     Investigators include patients referring for elective computed tomography coronary~     angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours~     after administration of contrast material. Investigators then measure serum creatinine and~     see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.~   "
72046|NCT02114333|"~     This study will compare the two vaccines that have been developed to prevent and/or lessen~     the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other,~     herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an~     ingredient that may enhance the body's immune response to the vaccine, and is currently~     investigational. The vaccines are being compared to assess their ability to stimulated~     protection against shingles. The study will provide an opportunity to determine the safety~     profile of each vaccine in a single trial. The study will also look at the effect of age on~     the immune response to the two vaccines and on the persistence of these responses.~   "
72047|NCT02114320|"~     Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful~     in patients with malignant biliary obstruction, selective biliary cannulation fails in some~     cases and conventional ERCP may not be possible in patients with tumor invasion of the~     duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or~     complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage~     (PTBD) is an useful alternative. However, PTBD had various complications and the presence of~     an external drainage catheter would also have a cosmetic problem related to the external~     drainage and an adverse impact on quality of life (QOL) of terminally ill patients.~      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case~     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and~     effective alternative in patients with failed conventional ERCP stenting. The potential~     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for~     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot~     be internalized, thus significantly improving the QOL of terminally ill patients, and~     possibly lower morbidity than PTBD or surgery.~      Up to date, only a few case series of EUS-BD with small numbers of patients have been~     published, and known the feasibility and safety in terms of the incidence of~     procedure-related clinical outcomes.~   "
72048|NCT02114307|"~     To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in~     treating patients with venous insufficiency.~   "
72049|NCT02114294|"~     This is a Randomized Controlled Trial (RCT) regarding conservative treatment of~     Patellofemoral Pain Syndrome (PFPS). Patellofemoral Pain Syndrome (PFPS) is a very common~     cause of knee pain in young active adults with a high rate of recurrent and/or chronic~     occurrence. PFPS is notoriously difficult to treat and has been referred to as one of the~     most vexatious clinical challenges in rehabilitative medicine. Its etiology is unclear but~     is commonly thought to be related to pathomechanics in the patellofemoral joint (PFJ). There~     are many factors that can influence PFJ mechanics. Among these, quadriceps strength and~     timing has been shown to be important. As such, treatment of PFPS has traditionally been~     based on correction of pathomechanics through influencing quadriceps strength and timing.~     However, a growing body of evidence is revealing the importance of strength and control of~     hip abduction and external rotation in PFPS. Hip strength in ab/adduction and rotation is~     thought to influence femoral positioning in the patellofemoral joint, thereby affecting PFJ~     mechanics. Several cohort and smaller RCT studies within the last 7 years have shown that~     additional exercises for hip strength and control give an improved effect in pain and~     function compared with quadriceps based training alone. A smaller RCT from 2012 compared~     isolated hip strengthening exercises to a control group and found surprisingly good results~     on pain in function in the hip strengthening group. The investigators plan a RCT in which~     isolated hip strengthening will be compared to traditional quadriceps training and a control~     group which will receive no structured training. Primary outcomes will be pain and function.~     This high-quality study will include 40-50 patients in each group, making it one of the~     largest of its kind on conservative treatment for PFPS. In contrast to the vast majority of~     studies of this type, this study will also include men, which will potentially help to fill~     a significant gap in the literature on this subject. The investigators study will therefore~     be an important contribution to elucidating the etiology of PFPS and improving treatment~     options for both men and women in the future. As well, the role of psychometric parameters~     will be examined and a standardized clinical test for hip abduction endurance will be~     developed.~   "
72050|NCT02114281|"~     A large panel of oral and dental diseases exist in patients suffering from chronic kidney~     disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and~     saliva and it has been already described in the literature. The consequences of oral~     diseases in systemic health are substantial, including increase of inflammatory parameters,~     alteration of nutrition and increase of cardiovascular risk factors. It has been shown~     before that several oral diseases can be considered as cardiovascular risk factor in the~     general population and in diabetic patients through the chronic inflammatory pathway. In CKD~     patients, the influence of oral diseases on the progression of the chronic kidney disease is~     not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients.~     That's why the interactions between dental health and CKD will be evaluated in this~     population of patients, at different stages of the disease (stages 2 to 5).~      The main objective will be to describe the oral diseases at each stage of CKD. Secondary~     objectives will be: (1) To evaluate the link between the oral health and the chronic kidney~     disease stage, the nutritional and inflammatory status; (2) Among patients needing dental~     treatments, to evaluate after 6 months and 12 months whether dental cares have an influence~     on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of~     dental treatments after the dental consultation including advises on dental health.~   "
72051|NCT02114268|"~     The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of~     an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to~     placebo when administered to healthy adult participants.~   "
72052|NCT02114255|"~     In the present study, the investigators want to investigate whether prior BCG-vaccination~     improves the efficacy of influenza (the flu) vaccination in young and/or old healthy~     volunteers and consequently could protect against influenza virus infection.~   "
86628|NCT01923480|"~     The purpose of this study is to determine the best rate of infusion of amino acids (15%~     CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages~     II to IVB head and neck cancer.~   "
72053|NCT02114242|"~     Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy~     (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are~     characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates~     in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and~     PSP remains an unmet need. Such biological markers are crucial for future~     disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for~     biomarker development since it constitutes the pathological hallmark feature in PD and MSA.~     The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein~     aggregation in alpha-synucleinopathies.~      The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and~     PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling~     at two study visits (baseline and after 12 months). Major secondary objectives are (i) to~     assess potential associations between the biomarker and clinical measures of disease~     severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker~     and its correlation to disease severity and progression in PD, MSA and PSP.~   "
72054|NCT02114229|"~     This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the~     treatment of patients younger than 22 years of age. Patients with recurrent or refractory~     AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT~     will receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy will~     be given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT are~     eligible.~      Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in all~     recurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B,~     C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy.~      This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNS~     MRT, (B) children < 36 months-old with newly diagnosed AT/RT, (C) children > 36 months old~     with newly diagnosed AT/RT. Children with concurrent MRT will be treated according to age~     and risk stratification schemes outlined for strata B and C and will have additional~     treatment for local control. Children with synchronous AT/RT will be treated with age and~     CNS risk-appropriate therapy, and also receive surgery and/or radiation therapy for local~     control of the non-CNS tumor.~      PRIMARY OBJECTIVES~        -  To estimate the sustained objective response rate and disease stabilization in~          pediatric patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid~          tumor in the CNS) (Stratum A1) treated with alisertib and to determine if the response~          is sufficient to merit continued investigation of alisertib in this population.~        -  To estimate the sustained objective response rate and disease stabilization in~          pediatric patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid~          tumor outside the CNS) (Stratum A2) treated with alisertib and to determine if the~          response is sufficient to merit continued investigation of alisertib in this~          population.~        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are younger~          than 36 months of age at diagnosis with no metastatic disease (Stratum B1) treated with~          alisertib in sequence with induction and consolidation chemotherapy and radiation~          therapy (depending on age) and to determine if the rates are sufficient to merit~          continued investigation of alisertib in this population.~        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are younger~          than 36 months of age at diagnosis, with metastatic disease (Stratum B2) treated with~          alisertib in sequence with induction and consolidation chemotherapy and to determine if~          the rates are sufficient to merit continued investigation of alisertib in this~          population.~        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are 3 years~          of age or greater at diagnosis with no metastatic disease and gross total resection or~          near total resection (Stratum C1) treated with alisertib in sequence with radiation~          therapy and consolidation chemotherapy and to determine if the rates are sufficient to~          merit continued investigation of alisertib in this population.~        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are 3 years~          of age or greater at diagnosis with metastatic or residual disease (Stratum C2) treated~          with alisertib in sequence with radiation therapy and consolidation chemotherapy and to~          determine if the rates are sufficient to merit continued investigation of alisertib in~          this population.~        -  To characterize the pharmacokinetics and pharmacodynamics of alisertib in pediatric~          patients and to relate drug disposition to toxicity.~      SECONDARY OBJECTIVES~        -  To estimate the duration of objective response and PFS in patients with~          recurrent/progressive AT/RT and MRT (Strata A1 and A2).~        -  To estimate PFS and OS distributions in patients with newly diagnosed AT/RT (Strata B1,~          B2, B3, C1 and C2).~        -  To describe toxicities experienced by patients treated on this trial, specifically any~          toxicities of alisertib when administered as a single agent or in combination with~          other therapy over multiple courses and toxicities related to proton or photon~          radiation therapy.~        -  To describe the patterns of local and distant failure in newly diagnosed patients~          (Strata B1, B2, B3, C1 and C2). Local control relative to primary-site radiation~          therapy, with criteria for infield, marginal, or distant failure will also be reported~          descriptively.~   "
72055|NCT02114216|"~     Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor~     2 (PAR2) have been implicated in the mechanism of acid induced inflammation in~     gastroesophageal reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression~     levels in the GERD patients and their relationship with endoscopic findings and reflux~     symptoms.~   "
72056|NCT02114203|"~     This study is being conducted to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle~     cell disease with and without co-administration with hydroxyurea. This study will also aid~     in selecting the doses for future studies and evaluation of substances in the blood which~     may help access the effectiveness of the drug.~   "
72057|NCT02114190|"~     With currently 35% of U.S. adolescents being overweight and one in six having metabolic~     syndrome, adolescent obesity is one of the major global health challenges of the 21st~     century. Few enduring treatment strategies have been identified in adolescent populations~     and the majority of standard weight loss programs fail to adequately address the impact of~     psychological factors on eating behavior and the beneficial contribution of parental~     involvement in adolescent behavior change. A critical need exists to expand treatment~     development efforts beyond traditional education and cognitive-behavioral programs and to~     explore alternative treatment models for adolescent obesity. Meditation-based mindful eating~     programs may represent a unique and novel scientific approach to the current adolescent~     obesity epidemic as they address key psychological variables affecting weight. Furthermore,~     the recent expansion of mindfulness programs to include family relationships shows the~     immense potential for broadening the customarily individual focus of this intervention to~     include broader factors thought to influence adolescent health outcomes. Thus, we propose to~     develop a mindful eating approach to eating behavior and weight loss specifically tailored~     for adolescents and their families. The first phase of our three phase development process~     will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an~     established mindful eating program currently being used with adult populations. We will then~     develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a~     family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful~     Eating-A to include family factors that influence adolescent eating behaviors. The second~     design phase will consist of an initial test of both intervention components to provide~     feedback on usefulness and acceptability (N = 10 families). The final phase will examine the~     overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A~     intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least~     one parent. Within this examination, post-treatment and 3-month follow-up comparisons across~     the two treatment approaches will be made and effect sizes within and between treatments~     will be assessed.~   "
72058|NCT02114177|"~     The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12~     weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus~     (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or~     treatment-experienced.~   "
72059|NCT02114164|"~     The AirSeal® System will allow for lower CO2 absorption rates than the Xcel® System.~     Furthermore, lower variance in pneumoperitoneal pressure will allow for less over-pressure~     events and peritoneal stretch, which may reduce postoperative pain.~   "
72060|NCT02114151|"~     The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir~     (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV)~     genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or~     treatment-experienced.~   "
72061|NCT02114138|"~     The risk for postoperative acute kidney injury (pAKI), as for any other postoperative~     complications (PC), comes from a number of interactions between a patient's health before~     surgery, strength to tolerate surgery and influences on the operating room environment. At~     this time doctors do not have good tools to predict which patients may be at risk of having~     this complication. The purpose of this research study is to develop a urine test that can be~     used to predict the risk for having problems with kidney function after major surgery.~   "
72062|NCT02114125|"~     Investigators assume that there are some positive effects of cognitive training and physical~     activities on cognitive function, depression and quality of life in a sample of older~     residents in long-term care facilities.~      The purpose of this study is to explore the effects of various interventions (physical~     activity, cognitive training, integration of physical activity and cognitive training) on~     different outcome indictors in institutionalized older residents.~   "
72063|NCT02114112|"~     Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP)~     cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks~     gestation to nasal prongs.~      Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for~     respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They~     will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per~     minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is~     the number of babies who came off NCPAP at the end of 72 hours of the intervention and~     remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia~     (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be~     the secondary outcomes.~   "
72064|NCT02114099|"~     Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative~     conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and~     cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may~     lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after~     the introduction of intravenous immunoglobulin therapy. However, significant persistent~     coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.~      Atorvastatin (Lipitor®), a kind of statin, is a selective competitive inhibitor of~     3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been safely and~     widely used for treatment of adult hyperlipidemia, prevention of coronary heart disease and~     familial hypercholesterolemia in childhood. In addition to the cholesterol-lowering effects,~     statins exerts diverse cellular, cholesterol-independent effects, including improvement in~     endothelial function, inhibition of neurohormonal activation, and reduction in levels of~     proinflammatory cytokines. Based on the above concepts, some patients with infrarenal~     abdominal aortic aneurysms received statin therapies and then the growth rate of aneurysms~     slowed down.~      Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression~     of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In~     NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And~     the investigators plan to conduct the clinical trial with atorvastatin to evaluate the~     effects of Atorvastatin on the persistent coronary arterial lesions/aneurysms in children~     with Kawasaki disease including safety and efficacy.~      Methods~      There are around 20 KD patients eligible for this study. After they sign the IRB-approved~     ICF, they will be enrolled for this study. Briefly, this study is divided into three stages:~     screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data~     analysis stage (III). Measurements include basic vital sign, electrocardiography, liver~     function, muscle enzyme, inflammatory markers and echocardiography.~      Predicted results~      1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in~     KD patients.~   "
72065|NCT02114086|"~     In this study the investigators observe the investigation, whether the new method for~     Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence,~     acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.~   "
72066|NCT02114073|"~     Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most~     commonly performed operation to slow-down the disease progression. In this study, we compare~     the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course~     and surgical success of trabeculectomy.~   "
72067|NCT02114060|"~     This is a randomized, double-blind, factorial study to compare the reduction in viral~     shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and~     Matrix-M2 adjuvant.~      Secondary objectives of the study include:~        -  Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2~          compared to placebo.~        -  Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among~          the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:~             -  Time to first clinical and/or virologic recurrence,~             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last~               dose of vaccine,~             -  Lesion rate (percent of days with genital lesions present) during the~               post-vaccination swabbing periods.~        -  Evaluation of cellular and humoral responses to GEN-003 antigens.~      Additional objectives include:~        -  Assessment of the correlation between immune responses and change in viral shedding or~          impact on clinical disease as defined above.~        -  Determination of the recurrence rate in a subset of subjects not receiving suppressive~          antivirals throughout the study.~      Eligible subjects will enter a baseline period to collect anogenital swabs for 28~     consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day~     intervals. Subjects will be followed for safety and immunologic response for 12 months~     following their last dose.~   "
72068|NCT02114047|"~     This study with evaluate blood flow in the lungs of patients prior to and after surgery for~     treatment.~   "
72069|NCT02114034|"~     The purpose of this prospective study is:~        -  to identify by cluster analysis the main phenotypes of severe asthma and factors~          involved in the severity,~        -  to determine the clinical and functional outcomes,~        -  to identify the factors associated with severe asthma from childhood to adulthood.~   "
72070|NCT02114021|"~     ABSTRACT:~      The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly~     (over tracheal tube cuff) compared with distilled water on the post intubation syndrome~     incidence. This study has not been carried out in Iran.~      99 patients of either sex undergoing elective surgery were recruited in a single blind~     randomized study. The patients, using randomization table, were divided into three groups.~     Anesthetics and medications used during surgery were similar for all the patients.~      For the all patients, the incidence of postoperative sore throat, cough and hoarseness of~     the voice in the different follow-up periods (1, 6 and 24 hours) based on the different~     types of medications were obtained.~   "
72071|NCT02114008|"~     To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV)~     have traditionally been minimized with overnight fasting. However, prolonged fasting can~     also have some adverse consequences and has been abandoned for some procedures in several~     patient populations with the exception of obese and/or diabetic patients. The aim of this~     study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated~     fasting.~   "
72072|NCT02113995|"~     Background To evaluate clinical results, insulin resistance and inflammatory response to~     trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received~     either traditional preoperative care or treatment following the ACERTO protocol.~   "
72073|NCT02113982|"~     This is a non-randomized, open-label, multi center study. A cycle of therapy is 5~     consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in~     period in which patients with BPDCN (previously untreated and previously treated) and AML~     (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose~     levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum~     tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not~     observed (identified in Stage 1).~   "
72074|NCT02113969|"~     Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment~     can be surgical or conservative using vaginal pessaries. These devices are introduced into~     the vagina aiming to reduces the prolapse.~      Pessaries have shown effectiveness in improving symptoms and quality of life. There are no~     randomized studies comparing them with surgery. This study design would be difficult to~     perform, because the inclusion criteria for both treatments are different. There are no~     currently standard protocols for the use of pessaries. This makes harder to widespread the~     usage of this conservative treatment.~      The aim of the investigators is to identify variables that influence the success of~     conservative management of genital prolapse at 1 year of follow up. Using these variables~     and an expert panel opinion the investigators will develop a standardized protocol for~     pessary management.~      Chile has a primary gynecological care system based midwives. Therefore having algorithms~     for pessaries usage becomes relevant. This algorithm can be implemented with basic training.~     This would increase the respond capacity, by the health care system to this disease,~     considering the scarce access to surgery.~      The investigators hypothesis is: It is possible to generate a standardized protocol of~     conservative management of symptomatic genital prolapse in patient's beneficiary of public~     health system in Santiago, Chile, using pessaries through a prospective cohort study based~     in the success of these devices with 1 year of follow up, measured with questionnaires of~     symptoms, quality of life and sexuality~   "
72075|NCT02113956|"~     The purpose of this study is to examine whether Guy2Guy (G2G), a text messaging-based~     healthy sexuality and human immunodeficiency virus (HIV) prevention program intervention for~     14-18 year gay, bisexual and queer men, is associated with HIV preventive behavior (e.g.,~     condom use) compared to an attention-matched control group.~   "
72076|NCT02113943|"~     The aim of the current study is to examine the role of serotonin on the cognitive parameters~     of motivation. They are embedded in a conceptual framework of motivation that merges~     decision-making and reinforcement learning theories. Every action is conceived as path from~     one state to another. The different states are associated to different values (positive for~     rewards and negative for punishments), and the different actions to different costs (risk,~     effort and delay). The tasks are designed such that the sensitivity to the state and action~     parameters can be inferred by fitting computational models.The primary objective is to~     characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive~     force task, in which participants are asked to squeeze a hand grip to win monetary rewards.~     Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive~     parameters of motivation (assessed with a motivational battery that includes rating, choice~     and learning tasks).~   "
72077|NCT02113930|"~     Definition: Idiopathic CD4+ T lymphocytopenia (ICL) is an immune deficiency first described~     in 1992 and characterized by the US Centers for Disease Control (CDC) as absolute CD4+~     T-lymphocyte count < 300/mm3 or < 20% of total T cells on more than one cell count; no~     evidence of infection with HIV-1/2 or human T-cell lymphotropic 1/2 (HTLV-1/2); and lack of~     a defined immune-deficiency disease or therapy for lymphocytopenia. Epidemiologic, clinical~     and immunological characteristics of the syndrome were described in 1993 and ICL is now~     considered a heterogeneous syndrome not caused by an infectious agent. Patients with ICL may~     show opportunistic infections such as disseminated Cryptococcus neoformans infection,~     Pneumocystis jiroveci pneumonia and John Cunningham (JC) virus infection as a result of~     profound cell-mediated immune-response deficiency.~      Few studies have focused on the pathophysiology of ICL. CD4+ T-lymphocyte phenotyping~     revealed increased CD95 expression that could be responsible for excess apoptosis leading to~     lymphocytopenia. Moreover, the membrane expression of C-X-C chemokine receptor type 4~     (CXCR4) was found impaired in T lymphocytes with ICL, and CXCR4 trafficking was improved~     with interleukin 2 (IL-2) treatment in some patients. Recently, mutations in nunc119, MAGT1~     and Rag were found associated with CD4+ T lymphocytopenia. In a prospective study of 39~     patients, CD8+ T lymphocytopenia (<180/mm3) and degree of CD4+ T-cell activation measured by~     human leukocyte antigen DR (HLA-DR) expression was found associated with poor prognosis.~      ICL is a heterogeneous disorder often associated with deficiencies in CD8+, CD19+, and/or NK~     cells. Long-term prognosis may be related to initial CD4+ and NK cell deficiency.~      Larger studies are needed to better identify the patients who might benefit from IL-2~     therapy. This is why the investigators conduct the Lympho-4 study, in which the~     investigators plan to include 200 patients with a suspected/proven diagnosis of ICL.~   "
72078|NCT02113917|"~     Different study of HLHa patients :~        -  Diagnosis criteria, because criteria are based on pediatric genetic studies.~        -  Physiopathological studies: genetic studies have demonstrated the role of CD8+ cells,~          in particular because they have a genetic defect affecting their cytotoxic functions in~          HLH pediatric. the aim is to establish if the same defect is found in both some or in~          all of HLHa patients. If this is the case, to then establish whether hypomorphic~          genetic mutations are responsible.~   "
72079|NCT02113904|"~     The main objective of this studies therapeutic : to determine the effect of Adalimumab~     (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome after~     3 months of treatment , with a post treatment period follow-up of 3 months.~      Second objectives are To evaluate the safety of Adalimumab in the context of NS To evaluate~     the improvement of the quality of life at 3 months To evaluate the improvement of pruritus~     and pain in the patients To study markers of inflammatory and allergy in NS prior and after~     treatment Benefit of the study An improvement by at least 20% of the cutaneous signs in~     these patients who suffer from a genetic incurable, chronic, painful and very afflicting~     disease would be of a great help for these patients. NS is a major source of social~     exclusion.~      Risks They are inherent to the risks of biotherapies, especially for an anti-TNF therapy,~     they comprise a risk of infection. Cutaneous infections occur mainly during infancy, and we~     have therefore chosen to treat patients over 4 years of age in this study.~      A close clinical surveillance will be set up (initially every week during the first month of~     treatment, then every month). This will represents a large number of visits but will provide~     a high level of security.~      Benefits/risks ratio In the absence of curative treatment for these patients with a severe~     genetic skin disease, the benefits/risks ration clearly appears to be in favour of an~     expected benefit.~   "
72096|NCT02113683|"~     The purpose of this study is the validation of MMS test to detect active tumor growth in~     different cancer types before and after therapy, as well as in the course of therapy and for~     subsequent relapse control compared to standard methods (clinical examination, imaging,~     tumor markers). It should be consider whether the MMS test has comparable diagnostic~     accuracy, and thus can replace more expensive or invasive procedures in future.~   "
73476|NCT02095613|"~     The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti~     (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life~     outcomes when compared to a second type of food supplement (corn-soy-blend) over the course~     of 12 months of food supplementation.~   "
72080|NCT02113891|"~     Advances in renal transplantation have increased life-expectancy in patients with end-stage~     kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft~     losses due to T-cell mediated rejection. However, emerging data suggest that the majority of~     late kidney failures may be attributable to antibody-mediated rejection (AMR), which poorly~     responds to the currently available therapeutics. Complement-fixing donor-specific anti-HLA~     antibodies are associated with the worst outcome in keeping with the well-established role~     of the complement in AMR pathogenesis. Eculizumab, the first licenced complement blocker,~     has been found efficient in reducing the occurrence of AMR lesions in highly sensitized~     patients. A few reports also suggest that complement blockade may be of great value as~     salvage therapy for graft-threatening severe AMR. However, no information is available in~     the literature about the interest of complement blockade in curbing the progression of~     subclinical acute AMR to chronic AMR.~      The purpose of this study is to determine whether complement blockade with eculizumab is~     effective and safe in the treatment of subclinical AMR in sensitized kidney transplant~     recipients.~      Despite appropriate therapies, up to 75% of patients having received a renal transplant with~     preformed donor-specific antibody display subclinical AMR on their 3-month protocol biopsy.~     Subclinical AMR is defined by histological lesions of AMR concomitant with stable graft~     function. Moreover, the extent of these lesions at 3 month post-transplant correlates with~     the occurrence of irreversible scars and chonic antibody-mediated rejection on the 12-month~     biopsy.~      This study aims to explore the efficacy and safety of eculizumab in patients exhibiting~     subclinical AMR on their 3 month-post-transplant biopsy, to reduce or even normalize~     microcirculation inflammation, and to prevent chronic rejection (transplant glomerulopathy)~     on the 12 month-screening biopsy. Eculizumab-treated patients will be compared with~     historical controls, matched for the lesions on the 3 month biopsy.~   "
72081|NCT02113878|"~     This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment~     for locally advanced head and neck squamous cell cancer.~   "
72082|NCT02113865|"~     The aim of this study is to establish a clinical score panel based on clinical, molecular~     and genetic parameters that allow us to stratify and obtain an early detection of patients~     with an increased risk of developing hepatocellular carcinoma (HCC).~   "
72083|NCT02113852|"~     This is an epidemiological,multicenter study of genomic and expression profiles of patients~     with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are~     to be recruited by investigational sites.Approximately 100 of them will be from~     retrospectively collected samples with detailed clinical and 2-year follow-up information~     after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will~     be collected after the patient had provided informed consent.All tissue samples will be~     analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA~     sequencing and chromosome copy number variation by SNP array at the designated laboratories.~   "
72084|NCT02113839|"~     The perception of breathlessness varies significantly among COPD patients with similar~     severity of airflow limitation; those with poorer perception report less exacerbations as~     compared to those with frequent exacerbations.~      Cross-sectional comparison of breathlessness perception in COPD patients with frequent~     exacerbations or without frequent exacerbations.~      To assess Breathlessness Perception the investigators will increase the ventilatory demand~     of the patients by CO2-rebreathing method.~   "
72085|NCT02113826|"~     Alveolar soft part sarcoma (ASPS), a rare subset of STS (<1%) harbors t(X;17)(p11;q25)~     translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high~     expression of angiogenic factors, sunitinib and cediranib produced overall response rates of~     55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.~   "
72086|NCT02113813|"~     The purpose of this study is to assess the safety and tolerability of ASP8273 and to~     determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This~     study will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential~     inhibition of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine~     the effect of food on the bioavailability of ASP8273.~   "
72087|NCT02113800|"~     The study is designed as an open-label, prospective, single arm, multicenter study of~     everolimus in histologically confirmed, neuroendocrine carcinoma G3 /neuroendocrine tumor G3~     after failure of first-line platin-based chemotherapy (open-label pilot study).~      The aim of this study is to provide a second line therapy to patients with any type of~     platinum based first line chemotherapy, to gather data on disease control rate and~     progression free survival.~   "
72088|NCT02113787|"~     The purpose of the study is to prove the bioequivalence of brand and generic topiramate.~   "
72089|NCT02113774|"~     The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal~     transplant patients does not have impact on the development of symptomatic urinary tract~     infection (UTI) or progression of renal impairment in patients during the first year after~     transplantation.~   "
72090|NCT02113761|"~     RATIONALE / CONTEXT The ECG records the electrical activity propagating along cardiac cells~     (from the atria to the ventricles). The standard 12 ECG leads placed on the chest measure~     the global activation of the heart and do not have the ability to detect small-scale~     disturbances or to pinpoint ectopic activity. By the 1960s, multiple electrodes were placed~     around the chest to try to understand the complexity of the distribution of electrical~     activity in relation to the single cardiothoracic geometry of each individual. The safety of~     this method is similar to the ECG but its superiority has been demonstrated by the detection~     of anomalies imperceptible to the standard ECG. The accuracy of the technique in localizing~     rhythm disturbances is on the order of 5 mm.~      OBJECTIVES Main objective: To evaluate the utility of noninvasive mapping during persistent~     AF electrophysiology procedure~      Secondary objectives:~        1. Compare the effectiveness of noninvasive mapping compared to conventional standard of~          care methods for AF mapping and ablation procedure.~        2. Evaluate the absence of recurrence of persistent AF after a follow up of 12 months~          after the procedure during a scheduled hospitalization.~      DIAGRAM OF RESEARCH European Diagnostic Study, feasibility, non-randomized, multi center~      RESEARCH PROCEDURES A trained clinical specialist places 252 dry gelled ECG electrodes on~     the patient's torso. The 252 ECG electrode array is hooked up to the CardioInsight system~     and body surface ECG recordings are made during the patient's arrhythmia. The patient is~     then sent to the radiology department for a CT scan (no contrast) to image both the heart~     and electrodes on the patient's torso. A trained clinical specialist from CardioInsight then~     segments the CT DICOM images from the CT scan to obtain epicardial anatomy and establish~     heart-torso geometry.~      The electrograms are processed by the system to produce movies of fibrillatory activity~     (both focal activity, and rotor activity).~      PROCEDURAL ENDPOINTS Primary endpoint: Acute AF termination to atrial tachycardia or sinus~     rhythm~      Secondary outcome criteria:~        -  Reduction in RF time compared to standard of care (historical control - comparable~          patient population)~        -  Reduction in procedure time compared to standard of care (historical control -~          comparable patient population)~        -  Freedom from persistent AF at the end of the 12 months F/U period STUDY SIZE~      The sample size was estimated at 100 patients, with up to 20 patients per center STUDY~     CENTERS 8 Centers :~        -  Brugmann - Brussels (Belgium)~        -  Clinique Pasteur - Toulouse (France)~        -  Medizinische Klinik und Poliklinik - Mainz (Germany)~        -  University ed Herzzentrum Freiburg Bad Kozingen (Germany)~        -  Deutsches Herzzentrum München, Munich (Germany)~        -  Kerkhoff Klinik, Bad Nauheim, (Germany)~        -  Sint-Jan Sint-Franciscus Xaverius, Brugge (Belgium)~        -  Clinique Ambroise Paré, Paris, France~      EXPECTED OUTCOME In patients referred for ablation of persistent AF, ECG mapping data will~     be correlated to the invasive procedure. It is expected that procedure time will be~     statistically shorter and total RF energy delivery is expected to be smaller than that of~     standard of care for AF treatment.~   "
72091|NCT02113748|"~     This randomized control trial will investigate whether a modality that generates more~     contractile muscle fatigue with lower ventilatory requirements render better results after a~     12-week exercise training program in subjects with COPD.~      Subjects will be randomized to either exercise in a training program including downhill~     walking or to exercise in a training program including conventional walking.~   "
72092|NCT02113735|"~     This study is being performed to evaluate the potential efficacy and safety of Acthar as a~     treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210~     subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio.~     Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using~     a blinded gradually tapering regimen, and subjects will be followed for 60 days~     post-randomization.~   "
72093|NCT02113722|"~     The purpose of this study is to determine whether the incidence of recurrent life~     threatening ventricular arrhythmias in patients with an implanted cardiac defibrillator~     (ICD) can be reduced if a surgical left stellate ganglionectomy is performed.~   "
72094|NCT02113709|"~     Objective: To find out how much visual improvement is possible in severe amblyopia using~     full-time occlusion therapy with an eye patch and to see if improvement is influenced by the~     patient's age.~      Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe~     amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients~     were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years~     (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases~     with organic visual loss were excluded; cases with previous part-time occlusion therapy that~     had failed were included in the study. Patients were given optimal refractive correction for~     a month, followed by full-time occlusion therapy along with near visual activities for 3-4~     hours/day. The therapy was continued until maximum visual recovery was achieved (6/6~     Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly~     for the next 18 months.~   "
72097|NCT02113670|"~     More than 11 million women in the United States suffer from stress urinary incontinence~     (SUI), the involuntary leakage of urine during everyday activities that put temporary stress~     on the abdomen and bladder, such as laughing, coughing, and walking. For women with SUI,~     this pressure often causes urine to leak involuntarily. SUI affects women of all ages~     including young mothers, pre-menopausal women, and seniors, and can result in significant~     emotional distress. Current solutions for SUI include disposable pads, behavioral treatment~     (pelvic floor physical therapy) and surgical intervention. Patients with SUI who failed~     conservative treatment and wish to be further treated by a surgery may require further~     work-up by urodynamic study in which abdominal leak point pressures (ALPP) defined and~     reflect the severity of SUI.~      There is continuous need to develop less invasive treatments for SUI that could minimize the~     use of pads, could be an alternative to painful, costly surgical procedure. The Trendlines~     Group lab solution is a non-surgical alternative in the treatment of SUI. The concept of the~     future treatment solution is based on simple physics: injecting a small amount of air into~     the urinary bladder, which eliminates or greatly reduces involuntary urinary leakage. The~     air bubble acts as a shock absorber to reduce the temporary pressure increase in the~     bladder that causes urinary leakage. The concept for the new treatment has been tested in a~     lab environment using lab jig tests and pig urinary system (bladder and urethra). The lab~     tests showed significant improvement in the bladder pressure when the treatment was~     implemented by suspending the stress pressure to a level that will not cause urine leakage.~   "
72098|NCT02113657|"~     The goal of this clinical research study is to study the impact of ipilimumab on the immune~     system of patients currently receiving hormone therapy. The safety of these drug~     combinations will also be studied.~   "
72099|NCT02113644|"~     The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function~     markers are already present in children of different weight categories and whether these are~     age dependent. Also differences - and relationships - between vascular function measurements~     and plasma biomarkers between lean and overweight/obese children will be compared.~   "
72100|NCT02113631|"~     1. The primary objective is to study the comparative effectiveness and tolerability of~          boceprevir vs. telaprevir in HCV treatment, within the VA population.~        2. The secondary objective:~             -  Resource use: recording of differences in resource use, such as direct costs~               (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization~               etc.) as the study will not only derive data by comparing those two drugs but also~               study the effect on different treatment lengths.~   "
72101|NCT02113618|"~     To purpose of the present study is to investigate the feasibility and efficacy of a~     computerized working memory training in improving cognitive functioning and alcohol use~     outcomes, in individuals with alcohol use disorders.~   "
72102|NCT02113605|"~     The purpose of the trial is to develop a treatment protocol to be used in trials studying~     internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The~     study size is not based on power calculations but the estimated sample necessary to develop~     a treatment protocol. This study will include 20-30 children with FGID and their parents who~     will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of~     exposure-based CBT. The study uses a pre- post-design with no control group.~   "
72103|NCT02113592|"~     The overall aim of this study is to adopt an integrative rehabilitation approach for helping~     patients adopt self-management skills for managing chronic pain, limiting use of opioid~     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,~     sleep problems) that is feasible and sustainable within the primary care setting.~   "
72104|NCT02113579|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of~     participants, and check for sensitive teeth.~      During the first 2 weeks, participants will brush their teeth 2 times a day with the~     fluoride toothpaste provided.~      Then, if they qualify to continue in the study, participants will be assigned to one of two~     treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently~     sold on the market. Both groups will each have an investigative mouth rinse to use as well.~     Participants will have an equal chance of being assigned to any one of the three groups.~      For the next 4 weeks, participants will use their assigned products according to the~     directions provided. At Visit 1, participants will be supervised while they brush their~     teeth to ensure they understand the directions. They will also have supervised use of the~     products at Visit 2.~      Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity~     during the study.~   "
72105|NCT02113566|"~     The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo~     in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety:~     There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen~     versus and both will be well tolerated.~   "
72106|NCT02113553|"~     This is a multicentre, prospective study willing to evaluate AMH levels changes in response~     to chemotherapy plus GnRHa.~      In the present study we propose to determine AMH levels in breast cancer patients, aged~     <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the~     aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve~     exerted by GnRHa.~   "
72107|NCT02113540|"~     As the effect of statin use before the angiography to prevent contrast induced nephropathy~     (CIN) is not well-known, the aim of the current study is to assess the effect of~     atorvastatin on prevention of CIN in patients undergoing coronary angiography.~   "
72119|NCT02113384|"~     During the course of tumor growth and possibly by manipulation during the surgical~     procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may~     give rise to local recurrence or contribute to the formation of metastatic disease,~     specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the~     peritoneal cavity at the time of surgery might therefore be of value for prediction of~     disease recurrence with subsequent prognostic implications for these patients. In this study~     the investigators aim to determine the presence of exfoliated tumor cells in peritoneal~     lavage samples from patients undergoing surgery for LARC.~   "
86762|NCT01921738|"~     The aim of this study is to investigate the effects of Azithromycin (systemic and locally)~     on the clinical and microbiological parameters of periodontal in patients with chronic~     periodontitis.~   "
72108|NCT02113527|"~     Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the~     gastroduodenal region in the absence of any organic, systemic or metabolic disease that is~     likely to explain the symptoms. FD can be further subdivided into two diagnostic categories:~     postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).~      Disorders of gastric electric activity and abnormal gastric emptying are probably actively~     involved in the FD onset. Different noninvasive procedures may be applied in order to~     evaluate the gastric motor functions such as 13C breath testing and cutaneous~     electrogastrography. Besides, different gastrointestinal peptides (i.e. CCK, peptide YY,~     Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II) are~     involved in the control of gastroduodenal motility.~      Aims of the present study are: 1) to evaluate the GI peptide circulating concentrations, the~     gastric electrical activity and gastric emptying time by applying noninvasive procedures in~     patients suffering from functional dyspepsia and 2) to test whether a significant difference~     exists between the two diagnostic categories of meal-induced dyspeptic symptoms~   "
72109|NCT02113514|"~     Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if~     Appalachian women have unique risk factors for an abnormal Pap smear that might contribute~     to the increased risk of cervical abnormalities, specifically cancer, in their communities.~   "
72110|NCT02113501|"~     Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of~     progression to invasive disease. Because the depth of substaging seems to identify two~     separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a~     differential treatment strategy for each group. The main hypothesis is that HighGradeT1a~     bladder cancer can spare a second endoscopic procedure.~   "
72111|NCT02113488|"~     Our aim was to identify the causes non-attendance at scheduled appointments at the Clinical~     Medicine Outpatient care system at the Italian Hospital of Buenos Aires (HIBA).~   "
72112|NCT02113475|"~     Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The~     Registry will track patient outcome and quality of life over 60 months for treatment with~     anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT)~     in accordance with current treatment guidelines .~   "
72113|NCT02113462|"~     The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of~     insulin resistance and an independent predictor of cardiovascular risk. The investigators~     aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in~     patients with CKD.~   "
72114|NCT02113449|"~     Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues~     and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic~     rhinitis have shown that nasally administered CO2 may provide relief of the associated~     symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration,~     and may persist for four to six hours.~      This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as~     evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who~     qualify and choose to participate in the clinical study will be administered nasal CO2 under~     medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for~     self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and~     completion of assessment questionnaires.~   "
72115|NCT02113436|"~     This study is a multicenter, stratified, randomized, active control, double-blinded,~     parallel-group comparative study with an open-label extension period. The study is designed~     to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two~     inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two~     inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study~     is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg~     one or two BID for 16 weeks.~      The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and~     receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The~     subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the~     run-in period. The subjects who meet the eligibility criteria for randomization will be~     stratified according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of~     the two treatment groups.~      The total duration of participation in the study will be 10 weeks for a comparison period~     completion and 27 weeks for a completion.~   "
72116|NCT02113423|"~     The hypothesis of the study is to address the efficacy and toxicity profile of~     aforementioned four modalities for rT1-2 NPC.~      Characters of the patients:~        -  list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC~          were diagnosed~        -  list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT~          Combined 3D-CRT or IMRT).~        -  list item three: Median time to recurrence was 30 months (range 1-180months). The~          median follow-up time was 28 months (range, 4-135 months).~   "
72117|NCT02113410|"~     The current study is a randomized controlled clinical trial to test the feasibility of~     recruiting, randomizing, and having older adults with osteoarthritis (OA) adhere to and~     safely complete the Sit 'N' Fit Chair Yoga program and the HEP program (primary objective).~     Secondary objectives of the study are to determine the effect of the Sit 'N' Fit Chair Yoga~     Program to reduce levels of pain; improve physical function, psychosocial function, and life~     satisfaction in adults over 65 years of age who are unable to participate in standing~     exercise. Participants at two sites will be randomly assigned to either the intervention~     group (Sit 'N' Fit Chair Yoga) or attention control group (Health Education Program). Data~     collectors will be blinded to group assignments. Data will be collected prior to the~     intervention (baseline), after 4 weeks, and after 8 weeks. Follow-up data will be collected~     after 1 month and after 3 months after completion of the intervention to measure the extent~     to which effects of the intervention continue. Evaluations will include physical measures~     and self-report measures.~   "
72118|NCT02113397|"~     The purpose of this study is to characterize bacterial diversity and richness in the sputum~     of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous~     alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).~   "
73674|NCT02093000|"~     This is a prospective, open-label, single arm, non-interventional study will investigate the~     effectiveness of Avastin monotherapy for patients with lung adenocarcinoma who previously~     received 4 to 6 cycles of induction platinum doublet plus Avastin. The study is expected to~     last approximately 28 months.~   "
72120|NCT02113371|"~     The current project is a safety and health intervention for home care workers conducted~     within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total~     Worker Health.~      The objective of this five-year project is to create sustainable health and safety~     communities of practice within a population of typically isolated home care workers. The~     intervention is a team-based, peer-led scripted curriculum that integrates health promotion~     and protection topics, as well as proven elements of social support groups for caregivers.~     The investigators hypothesize that this intervention will increase measures of experienced~     community of practice, well-being, and diet, exercise, and safety behaviors, as compared to~     a usual practices control condition.~   "
72121|NCT02113358|"~     Fluid management during neurosurgery presents a special clinical agenda. Volume overload can~     have detrimental effects on intracranial pressure by increasing either cerebral blood volume~     or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive~     fluid strategy may risk hemodynamic instability.~      Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have~     been shown as a more precise parameters for fluid management including in neurosurgical~     patients. The threshold of SVV is reported about 10-15%. In this study, the investigators~     aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy.~     Randomization will be generated by computer sampling. One of the two groups of patients will~     be managed with fluid bolus to keep intraoperative SVV <10% presenting the normovolemia~     group. The other group of patients will be kept intraoperative SVV <18% which is slightly~     above previously reported SVV threshold upper limit. The second group thus presents the~     restrictive group. Clinical outcomes, laboratory analysis including S100-B for neuronal~     damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will~     be compared.~   "
72122|NCT02113345|"~     The purpose of this research is to explore the relationship of metamemory and memory of~     elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders~     with mild cognitive impairment and low memory self-efficacy.~   "
72123|NCT02113332|"~     Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients~     on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight.~     However, to date there are no clinical trials of liraglutide added to insulin therapy, a~     population of patients generally having worse glycaemic control and weight gain. In clinical~     guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic~     option for type 2 diabetic patients.~      The primary study aim is to evaluate whether the addition of liraglutide, compared to~     placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with~     inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is~     defined as treatment with any basal insulin combined with separate meal time insulin~     injections before the main meals, i.e. an insulin regimen with premixed insulin is not~     considered as MDI.~      The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.~   "
72124|NCT02113319|"~     In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal~     Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also~     increased in case of mutations of receptors tyrosine kinase. For patients with a high~     Minimal Residual Disease level at the end of consolidation or in molecular relapse,~     maintenance by the inhibitor dasatinib is proposed.~   "
72125|NCT02113306|"~     A recent study with rats showed that electrical stimulation of the vagus nerve (VNS)~     facilitates extinction of fear (Pena, Engineer, & McIntyre, Biological Psychiatry, 2013).~     The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing~     noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the~     CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred~     during exposure of the fear conditioned stimulus (CS), and not when stimulation was given~     immediately following exposure. These results may have implications for the treatment of~     anxiety disorders in humans. However, until recently, the only means to investigate the~     effects of VNS on human fear learning would have required the invasive implantation of vagus~     nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device~     has been approved for use in the E.U. for the treatment of psychological disorders.~      This study proposes to use a t-VNS to investigate its effects on fear learning and~     extinction in (healthy) humans. Previous research has only investigated the effects it has~     on human mood and memory. The results obtained suggest that it reduces negative affect and~     enhances memory, findings which are consistent with those reported for rats. It is thus~     reasonable to expect that t-VNS will facilitate the extinction of fear in humans.~      The present study aims to answer the following research questions:~      Does t-VNS during extinction training:~        1. accelerates extinction curves~        2. reduces spontaneous recovery of previously extinguished fear~        3. reduce re-acquisition of fear~        4. reduce generalization of fear to other stimuli that resemble the CS+?~        5. facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?~   "
72126|NCT02113293|"~     This study is intended to investigate the tolerability and the safety of Cyclosporine A~     containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy~     volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo~     (vehicle) in the first part (first period) of the study, and switched to the alternative~     dosing in the second part (second period) of the study. An ophthalmological assessment of~     the eyes will be performed, and a questionnaire will be issued in the beginning and after~     each dosing. Additionally physical examinations, safety laboratory and ECGs will be~     performed, and blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).~   "
72136|NCT02113163|"~     The primary objective of the study is to contrast the pharmacokinetic profiles of metformin~     and EPA delivered separately as co-administered products (metformin hydrochloride or~     Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin~     eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to~     evaluate the safety and tolerability of single and repeat single doses of TP-101.~   "
72729|NCT02105363|"~     The investigators want to determine how much the skin on the back can move left to right of~     the midline and also up and down, in subjects presenting for procedure or in healthy~     volunteers. The investigators will do measurements on the back using samples of individuals~     in all age groups.~      It is hypothesized that an explanation to late epidural failure could be related to excess~     back motion in individual subjects.~   "
72127|NCT02113280|"~     Patients with wear and tear in their knees (osteoarthritis) are often referred to~     orthopaedic surgeons following a sudden worsening of pain and mechanical symptoms (grinding,~     locking, giving way) in their knee due to tears of their meniscal cartilages. These tears~     are described as degenerative as they are not usually caused by a single injury but rather~     accumulation of wear and tear. It is not clear from the current available evidence what the~     best treatment for these patients is. Their underlying arthritis is not bad enough to~     require joint replacement yet and they were usually managing well with minimal problems from~     their knee until experiencing the meniscal tear. However, some of their symptoms are likely~     to be due to the arthritis rather than just the tear. Current treatment for these patients~     is usually in the form of conservative treatment with physiotherapy and supervised exercise~     or using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know~     from previous research that most of these patients will improve over time to some extent but~     it is not clear whether a greater improvement can be expected following surgery and if so,~     whether this applies to all patients with this problem or not.~      Our study is intended to compare the outcome of patients with proven degenerative meniscal~     tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised~     exercise or supervised exercise alone. They will be randomly assigned and the outcome will~     be assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury~     Score [KOOS], SF12, visual analogue score for pain) and whether the patients go on to~     require further surgery during the period of the trial. The patients will be assessed at~     baseline, at 6 weeks, 6 months, 12 months and 24 months.~   "
72128|NCT02113267|"~     Background:~      Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only~     within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in~     the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty~     and food may be stuck, which typically require acute hospital care with operational action~     under general anesthesia.( 3,4 ) The standard treatment today is local treatment with~     steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers,~     there is only one randomized study which has shown that budesonide has a significant effect~     exaggerating that of placebo. However, the main end-point in this study was the degree of~     tissue inflammation.(6) In a separate study using validated questionnaires , we have shown~     that patients with EoE have distinct organ-specific symptoms and a lowered quality of life .~     These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that~     study was not randomized or placebo controlled no causal conclusions could be drawn~     regarding the treatment effect, but the method of validated questionnaires proved sensitive~     to changes in symptomatology.(7) Purpose The primary purpose of this study is to evaluate~     the effect of local steroid treatment with mometasone furoate on swallowing problems in~     patients with EoE . Secondarily, to evaluate the effect on patient quality of life and the~     presence of side effects.~   "
72129|NCT02113254|"~     The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized~     countries. The macular pigment (lutein and zeaxanthin) could play an important role in the~     arisen of the AMD. The food supplementation by corn with strong concentration in macular~     pigment could increase the density of the macular pigment. This could, in the future,~     represent a strategy of prevention of the AMD. The main objective of this study is to detect~     an increase of the macular pigment density after the consumption of this corn at healthy~     volunteers.~   "
72130|NCT02113241|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and~     is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have~     benefits on blood pressure, triglycerides levels and help to raise the levels of high~     density lipoproteins cholesterol (c-HDL).~      The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome,~     insulin sensitivity and insulin secretion.~      The investigators hypothesis is that the administration of dapagliflozin modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
72131|NCT02113228|"~     This study proposes to verify the total energy expenditure in patients with short bowel~     syndrome using the doubly labeled water method, as well as determining the rate of oxidation~     of nutrients, aiming to assist the management of nutritional therapy for these patients.~   "
72132|NCT02113215|"~     Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals~     relative to young people, despite no significant difference in fasting plasma TAG~     concentrations. Our general hypothesis is that the increase in intrahepatic fat with age~     results from reduced VLDL turnover, and therefore elderly individuals in this study will~     display lower VLDL turnover rates than young individuals. The aims of this study are a) to~     compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and~     a constant infusion method of assessing VLDL turnover.~   "
72133|NCT02113202|"~     There is a need for better visualization of polyps during surveillance endoscopy in patients~     with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch~     Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma~     associated biomarkers is a promising technique to accommodate this need. The biomarker~     Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue~     versus normal tissue and has proven to be a valid target for molecular imaging. The~     University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the~     VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer~     therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when~     bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing~     adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR)~     fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this~     feasibility study, next to the determination of the optimal tracer dose.~   "
72134|NCT02113189|"~     The purpose of this study is to investigate the impact of a specifically designed leg brace~     on walking endurance in individuals with Parkinson's disease.~   "
72135|NCT02113176|"~     The purpose of this study is to determine the safety and efficacy of a drug minocycline in~     improving outcomes at 3 months after rupture of an aneurysm in the head.~   "
72137|NCT02113150|"~     In this prospective, randomized, clinical trial, we have investigated the effects of~     ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c~     levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney~     injury in CABG surgery.This study was approved by the Ethics Committee of Hospital and all~     patients were informed and gave written consent. Patients scheduled for elective CABG with~     cardiopulmonary bypass. Patients were randomly allocated to anesthesia with~     remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group.~     Blood samples were obtained before induction of anesthesia (baseline), at the end of the~     operation, and postoperative days 1, 2, and 4.~   "
72138|NCT02113137|"~     The purpose of the study is to evaluate the effect of various oral hygiene procedures on~     reduction of oral malodor.~   "
72139|NCT02113124|"~     Years after a suffering a brain injury, individuals remain in a physically and cognitively~     impaired state. The investigators believe that the concentrations of amino acids in the~     blood are chronically altered and yield negative effects on the individuals health.~     Preliminary data has shown significantly lower concentrations of amino acids in serum~     samples from the TBI population, these diminished levels of amino acids may be due to~     changes in the microbiome. Understanding these changes will help guide rehabilitative~     services for this population. Individuals with a chronic brain injury will donate samples of~     blood, oral tissue, and fecal matter to be compared to that of non-injured individuals.~     Genetic information from the hosts will be striped and discarded; participant's genetic~     information will not be retained. To better understand changes in the microbiome, any~     history of antibiotics and probiotics will be assessed.~   "
72140|NCT02113111|"~     The study aims to investigate~        -  if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with~          chronic diseases~        -  the effects of fasting on physical and mental well-being, quality of life and body~          awareness/image~        -  the association between patients characteristics and the perceived health benefit after~          fasting~        -  the association between Diagnosis according to traditional Chinese medicine and~          physical and mental well-being during the course of fasting~        -  experiences and perceptions of patients during fasting therapy~   "
72141|NCT02113098|"~     The purpose of this study is to determine whether the add load on non-paretic lower limb of~     individuals that suffer a stroke, while walking on a treadmill, is effective for restore~     gait symmetry of these individuals, in a subacute phase of stroke.~   "
72142|NCT02113085|"~     The purpose of the study is to implement a full-scale efficacy trial of the My Life program.~     Conducted in partnership with the Oregon DHS Foster Care Program, the impact of the~     intervention will be being evaluated with a randomized experimental longitudinal design. Two~     hundred and ten youth, ages 16.5-17.5, will be enrolled in 3 waves, and randomly assigned to~     either a comparison group that receives typical foster care services or to a treatment group~     that participates in the key elements of the model, including instruction in~     self-determination skills, support in leading their own coordinated inter-agency transition~     planning meetings, and participation in workshops with mentors. Outcomes, including youth~     self-determination, quality of life, employment, mental health, educational achievement and~     independent living, are assessed pre-intervention, at the conclusion of intervention, and at~     12 months post-intervention. The proposed study will provide important information on the~     efficacy of the model for all youth exiting the foster care system, yielding unequivocal~     data on whether enhanced self-determination mediates, at least partially, various outcome~     areas, including mental health, educational achievement, employment, independent living, and~     quality of life; evaluating the effect of special education status, gender, and race as~     moderating influences on the impact of the intervention. Foster care experiences, such as~     trauma and placement instability, will be considered as covariates; direct effects of the~     intervention on these key foster care experiences will also be explored.~   "
72143|NCT02113072|"~     The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent~     wheezing in infants, stimulating the immune system to Th1 response.~   "
72144|NCT02113059|"~     The most relevant factor predicting morbidity and mortality after liver resections is the~     ability of the remnant liver to regenerate. The investigators recently demonstrated that~     serotonin and thrombospondin-1, two growth factors abundantly stored in platelets, seem to~     play a critical role in liver regeneration of patients after liver resection. The~     investigators now aim to gain more precise insight concerning the relevance of platelets and~     platelet derived growth factors in liver regeneration in humans. The investigators will~     focus on specific alpha-granula release as a key regulator of postoperative LR. Using peri-~     and intraoperative blood and tissue samples, platelet adhesion, granula release and~     induction of gene expression known to be involved in liver regeneration form experimental~     studies will be analyzed. This study should allow the investigators to verify observations~     from preclinical models and evaluate their relevance in the human setting. Furthermore, this~     might enable the investigators to identify new therapeutic targets.~   "
72145|NCT02113046|"~     The aim of this study is to investigate whether finnish binding pancreatico-jejunal~     anastomosis is feasible and prevents the risk for post operative pancreatic fistula after~     distal pancreeatectomy.~   "
72146|NCT02113033|"~     The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation~     for the treatment of congestive heart failure with reduced ejection fraction, and to report~     secondary measures of efficacy.~   "
72147|NCT02113020|"~     The objective of this clinical trial is to examine the clinical pharmacology properties of~     TAK-233 in healthy female subjects~   "
72148|NCT02113007|"~     This study will evaluate the safety and efficacy of high-dose rituximab combined with~     temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas~     (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age~     or older, or in patients 18 years or older who refuse methotrexate-based treatment.~   "
72149|NCT02112994|"~     This study will evaluate the safety and efficacy of sebelipase alfa in a broad population of~     patients with lysosomal acid lipase deficiency (LALD).~   "
72150|NCT02112981|"~     meriT-V is a Prospective,active control open lable clinical trial to compare safety &~     efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random~     assignment for treatment of coronary artery disease at multiple multinational centres.~   "
72154|NCT02112929|"~     The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and~     computed tomography to develop a new technique capable of objectively and quantitatively~     describing regional and structural lung abnormality. Since this is a relatively novel~     technique, the investigators first need to acquire imaging and clinical data from a group of~     participants with normal lungs. The investigators hope to generate an atlas of normality,~     which will form the foundation of future studies to compare with patients suffering from~     chronic respiratory disease. The investigators also aim to validate the new technique in~     terms of intra-subject reproducibility.~   "
72155|NCT02112916|"~     This randomized phase III trial compares how well combination chemotherapy works when given~     with or without bortezomib in treating patients with newly diagnosed T-cell acute~     lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help~     reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for~     cell growth. It may also help chemotherapy work better by making cancer cells more sensitive~     to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib~     is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic~     lymphoma.~   "
72156|NCT02112903|"~     The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea,~     vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following~     single oral doses of three modified-release (MR) capsules with differently coated multiple~     particles compared to one immediate-release (IR) tablet.~   "
72157|NCT02112890|"~     This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus~     (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.~   "
72158|NCT02112877|"~     This is a multi-center, prospective, single arm, non-randomized study to evaluate safety and~     efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective~     Performance goals. The follow-up period is 60 months.~   "
72159|NCT02112864|"~     Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery.~     Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a~     significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of~     this study is that dexamethasone, given pre operatively, would help reduce the incidence of~     post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory~     response, in patients undergoing elective thoracic surgery that includes thoracic epidural~     analgesia.~   "
72160|NCT02112851|"~     Randomized, placebo controlled, double blind, postprandial crossover study in male subjects.~     3 intervention arms, consisting of a control (Product A), a low dose processed whole orange~     (Product B) and a high dose processed whole orange (Product C), to determine the effect of~     the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma~     insulin concentrations will be quantified.~   "
72161|NCT02112838|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of IgA Nephropathy~   "
72162|NCT02112825|"~     The general objective of the study is to investigate the effect of regular aerobic exercise~     on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease~     and hypertension.~   "
72163|NCT02112812|"~     A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD~     patients compared to controls. As H. pylori infection is known to interfere with levodopa~     absorption, we embarked on this is a study to understand the effects of Helicobacter pylori~     infection eradication among a selected Malaysian population with Parkinsons disease, in~     relation to levodopa effectiveness and motor improvements.~      The study hypotheses are:~        1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time'~          duration.~        2. PD patients with H. pylori infection show clinical improvement in motor disability and~          quality of life after eradication therapy of H. pylori, assessed using UPDRS-III /~          PDQ39 questionnaires.~   "
72164|NCT02112799|"~     This Phase 1 trial will assess the dose-related safety and PK profile of different doses of~     NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with~     chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA~     levels and other virologic efficacy parameters will be assessed.~   "
72165|NCT02112786|"~     Participants receiving neuromodulation treatment for overactive bladder symptoms will be~     routinely fitted with an impulse generator. However, the setting on the impulse generator~     will be set to either intermittent or continuous stimulation. Participants will complete~     voiding logs and surveys for a month. Battery life will be interrogated.After a one week~     period were the device is turned off, the impulse generator will be turned to the opposite~     setting (intermittent or continuous) and the one month period will be repeated. Again,~     voiding logs, surveys, and battery life will be collected.~      The purpose of this project is to investigate the outcomes of intermittent versus continuous~     stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive~     bladder (OAB) syndrome. In addition, the potential for an improved battery life with~     intermittent stimulation will be quantified.~   "
72166|NCT02112773|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
72181|NCT02112578|"~     -  Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate)~          to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of~          treatment;~        -  Evaluation of impact on quality of life in vertigo;~        -  Compare the intensity of daytime sleepiness in the two treatment groups;~        -  Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;~        -  Compare the duration of treatment in both treatment groups;~        -  Compare Adehence;~        -  Compare the level of satisfaction from each group from the investigators and the~          subjects;~        -  Adverse events;~   "
72182|NCT02112565|"~     This phase I trial studies the side effects and best dose of City of Hope 29 (COH29) in~     treating patients with solid tumors that are refractory to standard therapy or for which no~     standard therapy exists. COH29 may inhibit an enzyme called ribonucleotide reductase and may~     interfere with the ability of tumor cells to grow.~   "
72167|NCT02112760|"~     1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound~          imaging.~           Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.~        2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis~          and multifidus) and the sensation and pain thresholds of patients with recurrent low~          back pain with asymptomatic subjects.~           Hypothesis: patients with recurrent low back pain have:~           (A) less activation of the transversus abdominis and multifidus, (B) peripheral and~          central sensitization, with decreased sensation and pain thresholds in the lumbar and~          foot areas.~        3. Specific aim 3. To determine the performance of the transversus abdominis and~          multifidus, and the sensation and pain thresholds by use of ultrasound feedback~          training in asymptomatic adults, and to compare these results with the traditional~          training protocols for trunk stabilization.~           Hypothesis: Specific stabilization exercise using ultrasound feedback training is more~          effective in activating deep trunk muscles and increasing sensation and pain thresholds~          than the traditional stabilization training protocol in asymptomatic adults.~        4. Specific aim 4. To determine the performance of the transversus abdominis and~          multifidus, and the sensation and pain thresholds by using the ultrasound feedback~          training in adults with low back pain, and to compare these results with the~          traditional training protocols for trunk stabilization.~      Hypothesis: Specific stabilization exercise using ultrasound feedback training is more~     effective in activating deep trunk muscles and increasing sensation and pain thresholds than~     the traditional stabilization training protocol in adults with low back pain.~   "
72168|NCT02112747|"~     This randomized clinical trial studies website access or genetic counseling with or without~     patient navigators on adherence to colorectal cancer screening recommendations in patients~     with newly diagnosed colorectal cancer and their first degree relatives. Websites for~     colorectal cancer prevention and genetic counseling may be effective methods to help people~     learn about cancer screening. Patient navigators may improve adherence to colorectal cancer~     screening recommendations. It is not yet known whether website access or genetic counseling~     is more effective with or without patient navigators.~   "
72169|NCT02112734|"~     There is an urgent need to prevent the onset and progression of food allergy in our~     population. Evidence demonstrates that food allergy and atopic eczema represent the earliest~     manifestations of the atopic march with 50% of infants with food allergy predicted to~     develop respiratory allergic diseases later in life. We report that Australia has the~     highest prevalence of IgE-mediated food allergy in the world, with 10% of infants having~     challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital~     admissions for life-threatening anaphylaxis. These changes are most pronounced in children~     less than 5 years, suggesting a causal role for early life determinants. We have primary~     data to inform hypotheses for the rise in food allergy, which appears to result from~     potentially modifiable factors related to the modern lifestyle, particularly Vitamin D~     insufficiency (VDI), and have demonstrated an association between VDI and increased risk of~     challenge-proven food allergy in 12-month old infants, which supports numerous ecological~     studies showing an increased risk of food allergy the further a child resides from the~     equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's~     sunny climate, population rates of VDI have steadily increased in infants and pregnant women~     in parallel to the apparent rise in food allergic disease. This association is biologically~     plausible, as there is evidence Vitamin D is critical to the healthy development of the~     immune system in early life. We propose an intervention study to assess if infant Vitamin D~     supplementation during the first year of life significantly decreases the risk of~     early-onset food allergy. Australia is ideally placed to answer this important question~     since, unlike the USA, Canada and Europe, there are no population recommendations for~     routine infant supplementation with Vitamin D and we are one of the few developed countries~     that do not supplement the food chain supply with Vitamin D.~   "
72170|NCT02112721|"~     The aim of this study is to determine whether vitamin D supplementation in overweight/obese~     individuals with vitamin D deficiency can improve insulin secretion and/or insulin~     resistance by decreasing subclinical inflammation.~      Results of the present study may help to identify new strategies to prevent type 2 diabetes~     in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong~     family history of diabetes).~      Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for~     type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve~     insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical~     chronic inflammation.~      Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals~     with low vitamin D levels will:~        1. improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function~        2. determine whether this relationship is mediated by a reduced chronic inflammation~   "
72171|NCT02112708|"~     Introduction: Minor psychiatric disorders are important in primary care, because of its high~     prevalence and consumption of healthcare resources generated.~      Objective: Evaluate the effectiveness of rational emotive behavioral therapy (REBT), as an~     instrument of social work intervention to enhance changes in the parameters of quality of~     life, medical consultations and drug use in patients with dysthymia.~      Design: Multicenter, prospective, not randomized clinical trial, with intervention and~     control group simultaneously in urban primary care settings and 1 year of follow up.~      Participants: Out-patients seen in two Primary Care centers diagnosed with dysthymia~     according to DSM-IV classification of American Psychiatric Association.~      Intervention: Subjects receive up to 8 biweekly individual sessions of thirty minutes of~     REBT administered by the Social Worker.~      Variables: Demographic data, educational level, coexistence, comorbidity, quality of life~     assessment, severity of depression, number of visits to the General Practitioner (GP) and~     drug consumption: sedatives / antidepressants.~      Expected Results: The expected results of the intervention, estimated from previous data,~     are:~        -  A decrease in attendance at medical visits per year~        -  An improvement in perceived quality of life, measured as values of the Quality of Life~          (QOL) questionnaire (Baker & Intagliata)~        -  An improvement in severity of depression, measured according to the Beck Depression~          Inventory.~        -  A reduction of treatment with psychotropic drugs (sedatives and antidepressants).~      Potential impact expected: The investigators hope that rational emotive theory is an~     effective intervention method for handling minor psychiatric disorders in clinical social~     work.~   "
72183|NCT02112552|"~     This pilot, phase II trial studies the side effects and how well paclitaxel given into the~     vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed~     by radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer.~     Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or~     stopping them from spreading. Giving the drugs in different ways may kill more tumor cells.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed~     by radiation therapy may be an effective treatment for uterine cancer.~   "
72172|NCT02112695|"~     Abnormal opioid system have been identified in addictive behavior and activity of the opioid~     system has also shown a strong link with the nutritional balance. A significant increase in~     endorphin levels was noticed after exercise, proportional to the duration and intensity of~     this activity. One brain imaging study showed an increase in opioid activity in athletes~     after endurance training. However , a decrease in opioid tone related to receptor~     desensitization in the brain has been raised in the sport and it is possible to feel like ,~     the subject must perform physical exercise more frequently . Consequently, in order to~     deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be~     assessed pre- training compared to a group of sedentary control subjects .~      Preliminary results of a previous study the investigators are conducting on anorexia nervosa~     (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and~     the regulation of gonadal function. However, the relation of cause and effect between these~     anomalies and undernutrition remains to be determined . Given the addictive component in the~     endurance sport and the variability of the nutritional status of its practitioners ,~     evaluation of brain activity in these subjects could provide additional answers.~   "
72173|NCT02112682|"~     STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the~     axilla, in order to positively influence the axillary morbidity rate and quality of life.~      PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not~     inferior to the current axillary treatment regimen in sentinel node positive breast cancer~     patients undergoing a mastectomy, in terms of regional recurrence rate.~      HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive~     breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary~     morbidity rate and to an increased quality of life, with non-inferior regional control,~     distant-disease free- and overall survival rates.~   "
72174|NCT02112669|"~     This document describes a prospective, multi center, study of the Laminate External Support~     device in brachiocephalic arteriovenous fistulas. The Laminate product constraints and~     directs the geometrical parameters of the fistula as well as the vascular diameter and~     gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and~     influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device~     is designed to improve short term maturation and long term patency of the fistula. The~     Laminate device is a permanent implant intended for use as a subcutaneous arteriovenous~     conduit support for vascular access.~   "
72175|NCT02112656|"~     The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal~     doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when~     used in conjunction with standardized radiofrequency ablation (sRFA).~   "
72176|NCT02112643|"~     The purpose of this study is to determine whether sodium selenite is helpful in the~     treatment of mild thyroid eye disease in North America.~   "
72177|NCT02112630|"~     The purpose of the study is to assess the safety and efficacy of triple therapy with~     pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic~     Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).~   "
72178|NCT02112617|"~     This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a~     possible treatment for neuroblastoma.~      Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at~     the top of the kidneys. However, it can also occur in other areas where groups of nerve~     cells exist, such as other areas of the abdomen, neck and near the spine.~      Conventional radiation therapy with photons is used as standard treatment for many patients~     with neuroblastic tumors. In this research study, the investigators are looking at another~     type of radiation called proton radiation which is known to spare surrounding tissues and~     organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring~     radiation. This may reduce side effects that patients would normally experience with~     standard radiation therapy or other means of delivering proton radiation therapy.~      In this research study, the investigators are evaluating the effectiveness of using proton~     radiation delivered to reduce side effects associated with radiation treatment. The~     investigators will also be assessing the late side effects experienced by participants in~     each treatment group.~   "
72179|NCT02112604|"~     This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary~     objective of this study is to examine factors that are related to sleep-disordered breathing~     and upper airway patency in critically ill patients who have been recently mechanically~     ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents~     given in the ICU prior to extubation and during the first night following extubation are~     associated with sleep-disordered breathing. The secondary hypotheses are that duration of~     mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered~     breathing during the night after extubation.~      The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be~     predicted by standard pulmonary function testing in the ICU.~   "
72180|NCT02112591|"~     Introduction:~      Minimally invasive procedures TOT (tension-free suburethral tape using transobturator~     approach)have been the standard for correction of SUI. However, around 28% of these patients~     exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an~     abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5%~     without obstruction. Our intention is to make the most of the idea of subtrigonal position~     in minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT).~      Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT.~      Materials and Methods:~      Study Population:~      Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis.~     Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or~     symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample~     was estimated 34 subjects are required per group.~      Study Design:~      It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when~     the SUI has been corrected with negative pad test and normal urinary flow.~      The results (efficacy) will be compared between the two groups using chi2 (group a/b versus~     success/lack of success). In all cases, p <0.05 will be considered significant.~      The data will be obtained with clinical evaluation, laboratory and radiological/imaging~     tests and the respective questionnaires during the visits before surgery, and at 2 and 6~     weeks, and 6, 12, and 24 months after surgery.~   "
72184|NCT02112539|"~     The study is to characterize the AggreGuide ADP Assay's performance.~   "
72186|NCT02112513|"~     The objective of this project is to evaluate clinical significance of measuring maternal~     blood estriol levels, after the administration of antenatal corticosteroids to enhance lung~     maturity. The investigators will test for associations of the change in maternal estriol~     with the development of respiratory distress syndrome. The investigators are also interested~     in determining whether salivary estriol is a valid surrogate to estriol blood assays. In~     addition the investigators will correlate these changes to pharmacokinetic (PK),~     pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and~     fetal respiratory outcome~   "
72187|NCT02112500|"~     Although the advent of advanced medical support for respiratory failure, the mortality rate~     of acute severe respiratory failure is still high and the life quality is frequently~     compromised from pulmonary fibrosis.~      The investigators hypothesize that the treatment using mesenchymal stem cell can be~     beneficial in patients with respiratory failure. The present study is a pilot study~     evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with~     respiratory failure.~   "
72188|NCT02112487|"~     Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in~     patients with PAH.~      To assess the long-term safety of macitentan in patients with pulmonary arterial~     hypertension (PAH) beyond treatment in the AC-055-310 study.~   "
72189|NCT02112474|"~     Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief~     has been used for decades. It is used most commonly in patients with chronic neuropathic leg~     pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to~     60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies~     with sub perception paraesthesias has recently challenged the conventional form of~     neurostimulation.The high frequency stimulation appears to show better pain relief for both~     back and limb pain in comparison to low frequency SCS, and may also to be effective in some~     subjects who did not respond to low frequency SCS.~   "
72190|NCT02112461|"~     Improving end-of-life care and the suffering caused by poorly controlled symptoms is an~     important public health concern. The development of an automated telephone symptom~     monitoring and support system that assists caregivers in providing end-of-life care and~     communicating information to the patient's hospice nurse has the potential to enhance the~     management of common end of life symptoms, thus reducing the suffering of patients at end of~     life as well as the suffering of their family caregivers. This study has developed such a~     system and is testing the effectiveness of this system.~   "
72191|NCT02112448|"~     The investigators hypothesize that intermittent bolus doses of morphine and midazolam can~     provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus~     infusions while using smaller total doses of both medications.~      The investigators will randomize patients to receive either morphine/midazolam as needed~     intermittently or morphine/midazolam drips plus intermittent doses to be received as needed.~     Pain scores will be recorded and total medications given will be recorded.~   "
72192|NCT02112435|"~     Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This~     disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure~     (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient~     refusal or intolerance). In these cases, treatment with mandibular advancement devices can~     bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of~     titratable versus active mandibular advancement splints in standard care environment. This~     will be based on the global response, which includes the apnea-hypopnea index and compliance~     in severe apnea patients who refused or where intolerant to CPAP. Following their severe~     apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement~     device, follow-up visits will be scheduled after 3 months of treatment involving clinical~     monitoring by a physician and a dentist.~   "
72193|NCT02112422|"~     The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given~     sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves~     quality of recovery in patients undergoing elective cesarean section as compared to the same~     dose given immediately prior to skin incision.~   "
72194|NCT02112409|"~     Surgical correction of scoliosis with instrumentation carries significant blood loss and~     needs for blood transfusion with its inherent risk and cost. In recent years, there is an~     increased interest in utilizing autologous blood as part of perioperative blood conservation~     strategy.~      The foremost mechanical methods of perioperative conservation of red blood cells including~     intraoperative cell salvage (ICS) and acute normovolemic hemodilution (ANH). They should be~     considered in all cases where significant blood loss (>1000 ml) or >20% estimated blood~     volume is expected, in patients with multiple antibodies or rare blood types and those who~     refuse allogenic blood products.~      Literature search has revealed that both cell salvage method and ANH utilized in elective~     surgeries are capable of minimizing allogenic blood transfusion respectively. Surgeries~     which are of significant relevance are aortic surgery, cardiac surgery and arthroplasty~     orthopaedic surgery. Combining the above two techniques such as in ATIS trial 2002 also~     shows that it is safe and significantly reduced allogenic blood requirements in aortic~     surgery. However till date, there is still lack of strong evidence that autologous blood~     transfusion technique is beneficial for scoliosis surgery in reducing allogenic blood~     transfusion.~      Hypothesis:~      The investigators hypothesize that the addition of ANH to ICS would confer additional~     benefit than using cell saver alone. By combining cell saver with hemodilution technique,~     the difference between pre-operative and post-operative Hemoglobin level will be smaller~     than using cell saver technique alone, hence minimizing the variation in perioperative~     Hemoglobin level - a predictor of allogenic blood transfusion.~   "
72195|NCT02112396|"~     The present study examines the efficacy of the Community Reinforcement and Family Training~     (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders~     (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the~     Intervention group has received CRAFT and prior to the WL- group having received CRAFT,~     treatment utilization of individuals with AUDs are substantially elevated in the~     Intervention group.~   "
72750|NCT02105090|"~     The purpose of this study is to examine in prospective, double-blinded randomised manner the~     ability of novel articaine-containing lozenge to enhance the procedure related compliance~     (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.~   "
72196|NCT02112383|"~     Procrastination is defined as a voluntarily delay of an intended course of action despite~     expecting to be worse-off for the delay, and is considered a persistent behavior pattern~     that can result in major psychological suffering. About one-fifth of the adult population~     and half of the student population are presumed having substantial difficulties due to~     recurrent procrastination in their everyday life. However, chronic and severe~     procrastinators seldom receive adequate care due to preconceptions and the lack of~     understanding regarding procrastination and the treatment interventions that are assumed~     beneficial. Cognitive behavior therapy is often deemed treatment of choice, although the~     evidence supporting its use is scarce, and only one randomized controlled trial has been~     performed. The primary aim of the current study is therefore to test the efficacy of~     cognitive behavior therapy delivered as either a group intervention or via the Internet.~     Participants will consist of students recruited through the Student Health Centre at~     Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants~     divided into two conditions will be employed; a ten week Internet-based cognitive behavior~     therapy intervention, and an eight week group intervention based on cognitive behavior~     therapy. The current study is believed to result in two important findings. First, different~     interventions inherent in cognitive behavior therapy are assumed to be helpful for people~     suffering from problems caused by procrastination. Second, both a group intervention and an~     Internet-based cognitive behavior therapy intervention are presumed suitable for~     administering treatment for procrastination, which is considered highly important as the~     availability of adequate care is limited, particularly among students. The current study~     will increase the knowledge regarding the efficacy of different treatments of~     procrastination, as well as enhance the overall comprehension of the difficulties related to~     dilatory behavior.~   "
72197|NCT02112370|"~     To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in~     BABA endoscopic and robotic thyroidectomy.~   "
72198|NCT02112357|"~     This study will assess the feasibility of sequencing locally advanced/metastatic~     gastrointestinal cancers in real-time to enable future treatment stratification by molecular~     characteristics. Targeted next generation sequencing of a panel of genes will be performed~     on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish~     if a patient is potentially suitable for a targeted therapy.~   "
72199|NCT02112344|"~     Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes~     at presentation is a relatively rare entity forming about 2% of all head and neck~     carcinomas.~      Typically patients are treated with ipsilateral modified radical neck dissection (MRND) and~     post-operative radiotherapy (PORT) or chemoradiotherapy.~      There is a lack of consensus on the radiotherapy target volumes that should be treated after~     neck dissection. The most common radiotherapy techniques are either unilateral cervical~     lymph node irradiation to achieve local control in the ipsilateral neck or TMI of the head~     and neck region with the aim of eradicating the primary and the microscopic neck disease.~      Treatment of the ipsilateral hemi-neck alone is of low toxicity and may achieve local~     control in the cervical nodes. Potential occult primary sites in the head and neck mucosa,~     and any sub-clinical metastatic disease in the contralateral side of the neck are left~     untreated. If a primary tumour subsequently becomes apparent the previous radiotherapy may~     make further radiotherapy difficult to deliver.~      Some groups recommend bilateral neck and total mucosal irradiation in this setting claiming~     improved local control. With conventional radiotherapy technique this is at the price of~     significant acute toxicity and chronic morbidity, mainly xerostomia with its associated~     complications and effects on quality of life (QOL).~      Intensity modulated radiotherapy (IMRT) has been shown to reduce the dose to salivary gland~     tissue and consequently may reduce the incidence of xerostomia and improve quality of life~     (QOL) in head and neck cancer patients.~      An analysis of parotid-sparing IMRT at the University of Michigan established a mean dose~     threshold for both stimulated (26 Gy), and unstimulated (24 Gy) saliva flow rates. For the~     same end-point (less than 25% of flow at baseline one year post radiation) Roesink et al~     established a TD50 of 39 Gy.~      The investigators performed a planning study to assess the feasibility of IMRT to spare the~     parotid gland while delivering bilateral neck and TMI. The mean dose to the contralateral~     parotid gland using IMRT was below the threshold of 24 Gy for unstimulated salivary flow,~     predicting a fairly low risk of radiation induced xerostomia. The mean dose to the~     ipsilateral parotid gland was 32 Gy which was below the TD50 dose based on the Roesink data.~      This study assesses the safety and tolerability of delivering IMRT in clinical practice to~     treat patients with SCCUP of the head and neck region, who require bilateral neck and~     pan-mucosal irradiation.~   "
72200|NCT02112331|"~     The optimization of newborns nutrition is a challenge especially for preterm newborns for~     whom nutrition plays a crucial part in cerebral and global development. Human milk is~     considered as the best food for newborns. Several short and long-term beneficial health~     effects were attributed to breastfeeding and have induced the increase of human milk in~     preterm newborns nutrition.~      Whereas the chemical composition of infant formula has been optimized to mimic human milk,~     there is still a major difference between the structure of human milk and commercial infant~     formulas. It is well known in adult nutrition that the structure of emulsions influences~     their susceptibility to hydrolysis, such results have been obtained either on in vitro or in~     vivo studies.~      Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the~     form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The~     globules are stabilized by a trilayered membrane composed mainly of polar lipids~     (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor~     compounds.~      The physical treatments apply to human milk or more generally to bovine milk to pasteurize~     or stabilize the milk modify the structure of the natural emulsion. Heat treatment for~     instance induces whey proteins denaturation and the adsorption of protein aggregates on the~     surface of the milk fat globules. Heat treatment also leads to the denaturation of bile salt~     stimulated lipase. These effects limit intragastric lipolysis in preterm newborns.~      Conversely, reduction of milk globules size, by homogenisation of milk, increases the~     specific surface available for lipase adsorption and limits the lost of fat during enteral~     administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat~     absorption of preterm newborns.~      The objective of this trial is to evaluate the effects of physical treatments~     (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric~     lipolysis and milk destructuration. This trial is conducted, in vivo, on preterm newborns.~   "
72201|NCT02112318|"~     The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a~     measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus~     rhythm maintenance after electrical cardioversion.~      Earlier studies performed in a retrospective fashion suggested that high AFR exceeding~     350-360 fibrillations per minute is an independent predictor of AF relapse after~     cardioversion, particularly in patients with duration of AF episode not exceeding 30 days,~     however this hypothesis has not been tested in a prospective study.~      CASAF is an observational study that will enroll patients with short duration (< 30 days) AF~     admitted for electrical cardioversion. Admission ECG will be extracted in a digital format~     and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks~     long follow-up period during which ECG control will be scheduled at week 1 and 6.~   "
72202|NCT02112305|"~     The purpose of this study is to determine whether nebulized magnesium sulphate is effective~     in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate~   "
72203|NCT02112292|"~     The endocannabinoid (eCB) system, a neurochemical signalling system consisting of~     CB-receptors and their endogenous ligands, has been found to be involved in food intake of~     sweet and palatable foods. Activation of the eCB system increases food intake and vice~     versa. The mechanism behind this effect is still unknown and the current study aims at~     clarifying why sweet food intake increases. It is hypothesized that sweet taste intensity~     increases and that sweet taste is experienced as more pleasant.~   "
72204|NCT02112279|"~     Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium~     that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder~     (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %.~     It is most often associated with overuse of antibiotics. According to Bartlett & Gerding~     (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile.~      The purpose of this study is to determine if donor fecal microbiota transplant via~     colonoscopy reduces refractory C-difficile infection better than current routine methods~     such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota~     transplant via colonoscopy will result in a higher C-difficile cure rate in affected~     patients versus care as usual in a retrospective cohort.~   "
72206|NCT02112253|"~     The motor tics associated with Tourette's syndrome may be reduced with deep brain~     stimulation of the anterior globus pallidus. The best area within this brain region and the~     best stimulation device settings are currently unknown. This is a study in which deep versus~     superficial electrode contact positions and two different amplitudes of stimulation are~     compared under scientific conditions. The hypothesis is that one contact~     position/stimulation amplitude combination will provide a better outcome than the others.~     Each study participant receives each of four different anatomical position/stimulation~     amplitude setting combinations over a 12 month period in randomized order followed by a~     6-month period of trial-and-error device programming to optimize control of motor tics.~     Motor tics, potential side effects, daily functioning and quality of life are assessed at~     the end of each trial stimulation period. At the end of the study, the study participant~     continues to have long-term deep brain stimulation treatment with whatever settings provide~     the most relief.~   "
72207|NCT02112240|"~     The purpose of this study is to see if investigators can develop a technique to identify~     sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer~     (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible~     patients are those with stage I-III rectal cancer undergoing standard low anterior resection~     or abdominoperineal resection.~      Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique~     using a mobile gamma camera will identify the sentinel lymph node in patients with rectal~     cancer with greater than 80% sensitivity.~      Subjects will receive injections of the tracer and dye prior to surgery, have preoperative~     SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to~     their scheduled surgery. During surgery, images of the rectum will be taken with a unique~     mobile gamma camera prior to removal and upon resection.~      If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the~     hope is to combine this technique with a less invasive surgery called transanal endoscopic~     microsurgery (TEM) for early stage rectal cancer patients.~   "
72208|NCT02112227|"~     Heart failure (HF) is the most common cause of hospitalization in older adults. The month~     after hospital discharge represents a vulnerable period, when patients are at increased risk~     of death and readmission to hospital. Research has shown that certain discharge-planning~     services can reduce death and readmissions, but these have not been widely implemented. In~     this study, we will group evidence-informed discharge-planning services into~     'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare~     patients for their transition from hospital to home. Through PACT-HF, patients will benefit~     from a comprehensive assessment of their health care needs, learn to recognize and manage~     symptoms of HF, and receive the information and follow-up care needed to optimize their~     health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods~     using a stepped wedge cluster trial design. We will compare the outcomes (hierarchically~     ordered) of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We~     anticipate that patients hospitalized at the sites with PACT-HF will have fewer~     readmissions, emergency visits, and deaths after discharge; report a better quality of life;~     and feel more prepared for discharge. We also anticipate that overall, PACT-HF will reduce~     health system costs.~   "
72209|NCT02112214|"~     The aim of this study is to define the role of H. pylori eradication in the prevention of~     gastric cancer and its precursors in the context of a population-based endoscopic screening~     program.~   "
72210|NCT02112201|"~     Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and~     trauma are particularly at risk for engaging in risky sexual behavior and for contracting~     HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs~     for girls who have this combination of behaviors is known to exist at this time. Researchers~     are developing, assessing, and implementing a family-centered prevention program to decrease~     girls' participation in the risky behaviors associated with the spread of HIV and STIs. The~     program also includes a group-based training and support program for parents.~   "
72211|NCT02112188|"~     The purpose of the study is to modify a type of counseling called Individual Meaning~     Centered Psychotherapy to meet the needs of Chinese cancer patients. Many cancer patients~     use counseling or other resources to help cope with the emotional burden of their illnesses.~     Counseling often helps them cope with cancer by giving them a place to express their~     feelings. Meaning-Centered counseling aims to teach cancer patients how to maintain or~     even increase a sense of meaning and purpose in their lives, despite cancer.~   "
72212|NCT02112175|"~     The purpose of this study is to compare the safety and efficacy of Lenalidomide versus~     Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly~     diagnosed multiple myeloma.~   "
72213|NCT02112162|"~     This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG)~     positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment~     response in patients with rectal cancer that has spread to nearby tissue or lymph nodes~     undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in~     the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid~     (DNA) and may also help doctors predict a patient's response to treatment before surgery.~     PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The~     combined scans give more detailed pictures of areas inside the body than either scan gives~     by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy~     and radiation therapy and help the surgeon make the best plan for removal of the tumor.~   "
72214|NCT02112149|"~     The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG~     exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.~   "
72215|NCT02112136|"~     The aim of this study is to identify families with ADPKD , characterize the phenotype and~     screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2~     negative carriers).~      Genome wide analysis will be performed in families without mutations identified.~   "
72216|NCT02112123|"~     The purpose of this study is to investigate the pharmacokinetic properties of icariin, an~     active ingredient in the over-the-counter supplement, Horny Goat Weed.~   "
72217|NCT02112110|"~     The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose~     of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.~   "
72218|NCT02112097|"~     AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only~     automatic injection system for delivery of injectable products to the optimum spot, just~     outside of the fascia, which exists subdermally (between the skin and muscle) or~     interfascial (between the deeper muscles). ASIS device creates that bloodless space,~     enhancing Enbrel's efficacy and preventing unnecessary distant spread and adverse reactions.~     This space remains bloodless as long as the skin is lifted up or filled with an injectable~     product. Although ASIS device was initially designed to best administer BOTOX for such~     muscular conditions as Upper limb Spasticity, Cervical Dystonia, Chronic Migraine,~     Strabismus, Blepharospasm, and Primary Axillary Hyperhidrosis, the technology will also~     benefit other injectable products, including: GAMMAGARD for Primary Immunodeficiency (PI)~     and Insulin for Diabetics, etc.~   "
72219|NCT02112084|"~     Individuals providing end-of-life caregiving to partners with terminal cancer often begin~     the bereavement process before the patient dies and with additional sources of stress. We~     know that grief for these partners can be long-term and impact virtually every aspect of~     their lives. This project will test the effectiveness of a new promising intervention that~     uses a dual process model (DPM) which focuses both on loss orientation (emotional loss and~     grief (referred to as LO)) and restoration orientation (learning new tasks of living that~     may have been the primary responsibility of the spouse who has died (referred to as RO~     tasks)).~   "
72220|NCT02112071|"~     The general objective is to investigate the effect of a 12 week walking exercise program on~     vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers~     in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).~   "
72221|NCT02112058|"~     The Supporting Healthy Marriage (SHM) evaluation was launched in 2003 to test the~     effectiveness of a skills-based relationship education program designed to help low- and~     modest-income married couples strengthen their relationships and to support more stable and~     more nurturing home environments and more positive outcomes for parents and their children.~     The evaluation was led by MDRC with Abt Associates and other partners, and it was sponsored~     by the Administration for Children and Families, in the U.S. Department of Health and Human~     Services.~      SHM was a voluntary, year long, marriage education program for lower-income, married couples~     who had children or were expecting a child. The program provided group workshops based on~     structured curricula; supplemental activities to build on workshop themes; and family~     support services to address participation barriers, connect families with other services,~     and reinforce curricular themes. The study's random assignment design compared outcomes for~     families who were offered SHM's services with outcomes for a similar group of families who~     were not but could access other services in the community.~   "
72222|NCT02112045|"~     This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to~     melphalan before a stem cell transplant works in treating patients with multiple myeloma.~     Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem~     cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may~     help multiple myeloma cells move from the patient's bone marrow to the blood where they may~     be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2~     Filgrastim (Granix) to melphalan before a stem cell transplant will work better than~     melphalan alone in treating multiple myeloma~   "
72223|NCT02112032|"~     This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and~     MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness~     against melanoma will also be evaluated.~   "
72224|NCT02112019|"~     Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It~     particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are~     frequently reported as presenting symptoms. These symptoms are in many cases accompanied by~     nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular~     manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects~     mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the~     irreversible damage to the saliva producing cells, the quantity and quality of saliva~     reduces. The progressive nature of the syndrome results in a further reduction of salivary~     flow. Due to hyposalivation the patients suffer from progressive dental decay, dental~     erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste),~     inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this~     can be qualified as a reduction in the quality of life. Until now no effective (palliative)~     therapy to relieve dry mouth complaints is available. A recent case series study suggests~     that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients~     suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline~     and cortisone and possible strictures are dilated. It is hypothesised that performing a~     sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and~     improve the reported mouthfeel score.~   "
72225|NCT02112006|"~     The purpose of this study is to compare two different injection sites for local anesthesia~     in patients having hand surgery. The hypothesis is that subjects receiving injections around~     the three nerves of the forearm will provide faster pain control and greater patient~     satisfaction than patients having one injection closer to the shoulder.~   "
72226|NCT02111993|"~     The objective of this study is to evaluate myocardial injury, if any, as quantified by~     cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation~     of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability~     (ULV) method vs. standard defibrillation threshold method.~   "
72260|NCT02111551|"~     This study plans to learn more about whether a nicotine-like investigational new drug,~     DMXB-A [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus~     and may help us to find new types of treatment for autism spectrum disorder. Subjects will~     come in for a screening visit and three more drug visits. There will be at least one week~     between each drug visit to allow the drug to be eliminated from your system completely.~     During each drug visit subjects will receive either a placebo (a capsule that looks like~     medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital~     signs and well being will be monitored by the study physician. Subjects will complete some~     paper and pencil tasks to test memory, attention, speed, and problem solving, some rating~     scales and questionnaires, and the study team will record brain wave patterns with an~     electroencephalogram (EEG) .~   "
72227|NCT02111980|"~     If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure,~     it can cause a serious infection. To prevent this from happening, a new device has been~     developed that uses radiofrequency (RF) signals to detect the presence of surgical sponges~     inside the body. The device is now being used routinely to make sure that no sponges are~     left inside a patient at the end of an operation. However, the RF device has not been~     implemented in procedures for patients with cardiac implantable electronic devices (CIEDs).~     While the device is FDA approved for use, there is a theoretical concern that the~     radiofrequency signals used to detect the sponges will change the settings on the pacemaker~     or the defibrillator. Changing the settings on a pacemaker might make it pace the heart too~     quickly or too slowly, while changing the settings on a defibrillator might cause~     unnecessary shocks or prevent it from shocking the heart if the patient were to have cardiac~     arrest.~      The purpose of this study is to test whether the radiofrequency device used to detect~     sponges can cause a clinically significant change to the settings on pacemakers and~     defibrillators. To minimize potential risk, the device will be tested only on patients who~     are having the pacemaker or defibrillator removed or replaced as part of their regular~     medical care, either because it is infected or because the battery has worn out. Before the~     pacemaker or defibrillator is removed, the settings will be carefully and completely~     recorded and the radiofrequency device will be used to scan the body for sponges as it would~     be done during normal operation.~      After the pacemaker or defibrillator is taken out, the settings will again be recorded and~     compared to the settings before the scan. In a standard device removal procedure, no~     clinically significant change in CIED settings would be expected. If a new pacemaker or~     defibrillator is implanted in the patient, it will not be exposed to the detection device at~     all. We will also test whether the RF device has any effect on temporary pacemakers that~     patients may receive after open heart surgery. We plan to perform testing in a total of 50~     patients, 40 with permanent pacemakers or defibrillators and 10 with temporary pacemakers.~   "
72228|NCT02111967|"~     In this study we compare the vitamin B12 status by measuring serum vitamin B12 and~     holotranscobalamin in type 2 diabetic patients with and without metformin treatment.~     Afterwars we investigate which biomarker could be adequate to reflect B12 status in~     metformin-treated patients.~      With the help of a questionnaire we assess clinical, nutritional and demographic factors~     which are associated with vitamin B12 deficiency.~   "
72229|NCT02111954|"~     Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new~     PET/CT radiotracer aiming at giving complementary information : more precise images and~     early localisation of recurrence to standard imaging~   "
72230|NCT02111941|"~     This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in~     treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary~     peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's~     peptide treated white blood cells may help the body build an effective immune response to~     kill tumor cells.~   "
72231|NCT02111928|"~     This observational pilot-study is intended to collect outcome data from a cohort of 30~     patients suffering from hyper-evaporative dry eye disease who are treated with the medical~     device NovaTears® eye drops for a duration of 5 to 7 weeks.~   "
72232|NCT02111915|"~     The rates of perinatal depression in South Asian women are reported to be amongst the~     highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In~     addition to its profound impact on women's health, disability and functioning, perinatal~     depression is associated with poor child health outcomes such as pre-term birth, infant~     under-nutrition and stunting. There is robust evidence that perinatal depression can be~     effectively managed with psychological treatments delivered by non-specialist health care~     workers. Our previous research conducted in Pakistan led to the development of the Thinking~     Healthy Program (THP). THP is a psychological treatment delivered by community health~     workers (CHWs) which more than halved the rate of perinatal depression among mothers and led~     to significant improvements in child health outcomes. To enhance access to such~     evidence-based psychological treatments, there is a need to examine the potential role of~     other human resources such as lay persons in delivering psychological treatments such as THP~     in poor resource settings.~   "
72233|NCT02111902|"~     The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last~     two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a~     high level of interest in the consequences of 25(OH)D deficiency and in particular its~     potential impact on black Americans. Fundamental new questions about the biology of vitamin~     D have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a~     physiologic abnormality in African Americans or does the 25(OH)D-iPTH system have~     sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which~     result from the gene- environment discordance observed in dark skinned populations in the~     US be a risk factor for metabolic disorders? Ultimately, the public health community and~     regulatory bodies must offer recommendations for optimal levels and supplementation. The~     investigators propose to utilize cohorts from an ongoing NIH-funded study designed to~     identify determinants of weight change and cardiovascular disease risk in five Afro-origin~     populations [Modeling the Epidemiologic Transition Study (METS)] to examine these questions.~     The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the~     five populations differ greatly in terms of sun exposure and dietary intakes. In addition to~     the extensive energy expenditure, dietary intake and obesity-related metabolic markers being~     measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and~     urinary calcium, plasma markers of bone resorption and formation, and quantitative~     ultrasound of the calcaneus. The associations of adiposity, weight change, cardiovascular~     disease (CVD) risk factors such as blood pressure and insulin, and bone strength with~     25(OH)D and iPTH will be assessed. The proposed study will provide a comprehensive~     assessment of the distribution and determinants of 25(OH)D-iPTH and related physiologic~     measures across a wide range of latitude and lifestyles. These data should contribute~     substantially to the understanding of the normal range within which these hormones~     function and their significance in Afro- origin populations.~   "
72234|NCT02111889|"~     The investigators hypothesize that response to kinase inhibitors is dependent on achieving~     pharmacological active drug levels in tumor tissue and that quantitative PET imaging can~     predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a~     quantitative PET based imaging tool to differentiate between patients who will respond to~     therapy with kinase inhibitors.~      The main objective of this study is to determine whether tumor concentrations of kinase~     inhibitors at pharmacological active doses can be predicted from PET studies using tracer~     amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective~     includes the development and validation of pharmacokinetic models for radiolabeled kinase~     inhibitors as well as validation of the microdosing concept for kinase inhibitors.~   "
72235|NCT02111876|"~     There is currently no good description of patients surviving an episode of acute hypercapnic~     respiratory failure in the ICU. For instance, the prevalence of OSA and sleep~     hypoventilation in a stable clinical condition is not known in this population.~      This prospective cohort describes the clinical profile, predictors of readmission (followed~     over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a~     stable clinical condition 3 months after ICU discharge) in patients treated for an episode~     of acute hypercapnic respiratory failure in the ICU.~   "
72295|NCT02111083|"~     The study involves 4 injections of insulin lispro and its purpose is to:~        -  Determine if 2 formulations of insulin lispro are treated by the body in a similar way.~        -  Compare how the 2 formulations of insulin lispro affect blood sugar level.~        -  Determine the safety of each insulin lispro formulations and any side effects that~          might be associated with them when given to healthy participants. The study is expected~          to last up to approximately 9 weeks for each participant.~   "
72236|NCT02111863|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy that involves taking white~     blood cells from patients' tumors, growing them in the laboratory in large numbers, and then~     giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes,~     or TIL and we have given this type of treatment to over 100 patients. In this study, we are~     selecting a specific subset of white blood cells from the tumor that we think are the most~     effective in fighting tumors and will use only these cells in making the tumor fighting~     cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause melanoma tumors to shrink and to see if this treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic melanoma who have a tumor that can be safely removed.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
72237|NCT02111850|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     metastatic cancer that involves taking white blood cells from the patient, growing them in~     the laboratory in large numbers, genetically modifying these specific cells with a type of~     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the~     patient. This type of therapy is called gene transfer. In this protocol, we are modifying~     the patient s white blood cells with a retrovirus that has the gene for~     anti-MAGE-A3-DP0401/0402 incorporated in the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-MAGE-A3-DP0401/0402 cells) cause tumors to~     shrink and to be certain the treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic cancer expressing the MAGE-A3 molecule.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin.~          They will stay in the hospital for approximately 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking.~   "
72238|NCT02111837|"~     This is a multicenter, randomized, double-blind, parallel-group, reference-controlled~     4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched~     infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis~     that growth of infants fed the specific lipid fractions-enriched infant formulae will be~     noninferior to growth of infants fed standard infant formula.~   "
72239|NCT02111824|"~     The goal of this clinical research study is to test the use of a minimally invasive~     multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy.~     The safety of the MIMIG intervention system will also be studied.~   "
72240|NCT02111811|"~     The purpose of this research study is to test the effectiveness of a new telephone~     counseling program for employed Veterans with depression called the Veterans Work and Health~     Initiative (V-WHI). 250 participants will be recruited and randomly assigned to one of two~     groups: the V-WHI experimental group or usual mental health care. The V-WHI counselors will~     address mental health and job-related issues that interfere with working. This counseling is~     provided solely over the phone with sessions every 2 weeks for 4 months (eight sessions~     total). At 8 months post-baseline, the V-WHI group is provided with a booster session.~     Participants in both groups are administered follow-up questionnaires at two time-points:~     month five and month nine.~   "
72241|NCT02111798|"~     This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day~     on initiation and maintenance of cocaine abstinence in a population of cocaine dependent~     methadone maintenance patients (N = 200) who can earn financial incentives for stopping~     their cocaine use. Bupropion is a promising medication for this purpose because of its~     previously demonstrated efficacy and safety as well as its pharmacological actions at~     dopamine systems. The study will use a stratified randomization strategy that will allow us~     to separately examine bupropion effects on abstinence initiation and relapse prevention.~     Outcomes will be tracked over a 6-month time frame that includes assessment of drug use~     during and after incentives have stopped. In addition, the project will provide novel~     information about mechanisms of medication effects by measuring subjective drug effects,~     drug vs money choices, and self-reports of pleasure derived from daily non-drug activities.~     The investigators hypothesis is that bupropion as compared to placebo treatment will both~     enhance rates of abstinence initiation in those who have difficulty stopping cocaine and~     retard rates of relapse in those who initially stopped their cocaine use. Furthermore that~     bupropion compared to placebo participants will report non-drug activities as more~     pleasurable (reinforcing), will engage in more of them. If hypothesized synergies are~     demonstrated, the study will point the way to a significant advance in improved treatment~     strategies for this critical group of drug abusers.~   "
72242|NCT02111785|"~     Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small~     blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms~     including headache, confusion, limb weakness, and difficulty speaking.~      There is currently no agreement among physicians as to the best way to treat this condition.~     One option is to do a surgery to drain the blood that has collected. Usually the surgery~     involves drilling small holes in the skull to relieve pressure and allow blood and fluids to~     be drained. Another option is to give medications such as steroids that might reduce the~     swelling. However, no drugs have been approved by the Food and Drug Administration (FDA)~     specifically to treat this condition. Some patients elect to have no treatment.~      The purpose of this study is to investigate whether investigational treatment with a 2 week~     course of oral dexamethasone is as effective as surgery for cSDH. The study hypothesis to be~     tested is: For patients with unilateral, symptomatic chronic subdural hematoma, there is no~     difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2~     at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with~     those treated with burr hole surgical drainage.~   "
72296|NCT02111070|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG~     Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single~     intramuscular injection~   "
72751|NCT02105077|"~     The purpose of this study is to establish a laboratory method to determine from blood~     samples whether a person has been treated with xenon.~   "
72243|NCT02111772|"~     In patients with asthma, reactions to allergens in the environment (such as mold, pollen,~     weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms.~     However, upper respiratory tract infections, typically those caused by the common cold~     virus, rhinovirus, can also cause asthma to get worse. In previous studies at the University~     of Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody~     (called IgE) in their blood, developed more persistent cold and chest symptoms when they~     were given an infection with rhinovirus (the most frequent cause of the common cold). The~     cold symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold.~     These symptoms, including nasal congestion, are similar to what you have experienced with~     previous colds.~      This study is being done to learn how a common cold caused by a viral infection affects~     people with asthma. The goal is to learn how to improve the care of asthma symptoms caused~     by the common cold virus (called rhinovirus). Most adults experience one or two colds caused~     by rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral~     infections are caused by this virus, primarily in children. Adults are less likely to~     experience significant changes in their asthma symptoms when they get colds, because they~     have developed protective immune responses from previous colds which help diminish symptoms.~   "
72244|NCT02111759|"~     The purpose of this study is to conduct a randomized controlled trial to determine if the~     knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft~     fixation has an effect on postoperative outcomes. The specific research questions are: what~     is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss;~     3) antero-posterior (AP) knee stability; 4) rate of re-operation.~   "
72245|NCT02111746|"~     The purpose of this study is to assess the efficacy of the intraoperative injection of~     prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal~     surgical incisions.~   "
72246|NCT02111733|"~     Evaluation of High sensibility troponin levels modification by hemodialysis in terminal~     renal failure patient at Sherbrooke University Hospital Center as determined by serial~     measurements. Verification of potential effects of these levels and their variation as~     predictors of cardiovascular outcomes and events at 6 and 12 months.~   "
72247|NCT02111720|"~     The decision to disclose one's serostatus to family members creates considerable emotional~     strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While~     disclosure to family members has been linked to positive outcomes including increased social~     support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and~     stress, and improved HIV disease management, the decision not to disclose can also lead to~     positive outcomes. To date, most research about serostatus disclosure has focused on the act~     of disclosing - the who, what, where, and when of disclosing - rather than the decision~     process involved. The investigator's long-range goal is to further refine and evaluate an~     intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this~     goal, the investigators are proposing a course of study with the following specific aims:~     Specific Aim 1. Assess the effectiveness of the intervention relative to an~     attention-control condition on a variety of primary outcomes related to disclosure and~     health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3:~     Explore the potential mediating effects of disclosure decision making on the primary~     outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics~     (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction,~     proximity, importance of disclosure), and contextual variables related to family (e.g.,~     adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the~     effects of treatment engagement, retention and expectations on outcomes.~   "
72248|NCT02111707|"~     To determine if the timing of administration of indomethacin affects the primary outcome of~     post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive~     pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.~   "
72249|NCT02111694|"~     The objective of the proposed research is to conduct a within-subject, experimental study~     that will describe mothers' feeding practices during typical bottle-feeding conditions and~     will examine whether removal of visual cues related to the amount of milk/formula in the~     bottle will alter these feeding practices. The investigators hypothesize that mothers will~     show higher levels of infant-directed feeding practices and lower levels of mother-directed~     feeding practices when using opaque, weighted bottles compared to when using standard, clear~     bottles. The investigators also hypothesize that infants will consume less breast milk or~     formula when fed from opaque, weighted bottles compared to when fed from standard, clear~     bottles.~   "
72250|NCT02111681|"~     The purpose of this study is to test the use of Calypso beacon implants as a way to~     determine where the lung tumor is located during radiation treatment. The Calypso beacons~     are small devices that are implanted in the lungs, near the tumor. They are able to send a~     signal to a tracking system to show where they are, and where the tumor is, as the patient~     holds their breath for the radiation treatment. The investigators want to find out what~     effects, good and/or bad, that this has on the patient and the way they treat the cancer in~     your lungs.~   "
72251|NCT02111668|"~     Aortic dilatation syndromes are comprised by a group of different syndromes, of which Marfan~     syndrome is the best described. Many of the aorta dilatation associated syndromes are~     heritable connective tissue disorders but some patients do not have any other phenotypical~     symptoms than aorta dilatation. The genetic variation in thoracic aorta dilatation is still~     unknown. This study aims on genetic evaluation of patients with thoracic aorta dilatation.~     Furthermore the study will focus on a registry angel trying to evaluate prevalence,~     mortality, morbidity and socioeconomically status of Marfan syndrome patients. This part~     will rely on registry data obtained from unique Danish registries.~   "
72323|NCT02110719|"~     In recent years, there has been an emphasis on the creation of enhanced-recovery,~     fast-track or multi-modal pathways to improve perioperative care (1-4). The goal of~     these programs is to reduce the length of hospital stay, decrease narcotic usage while~     improving pain control, accelerate post-operative recovery, and expedite return to baseline~     functional status. Pathways often are developed by a team of surgeons, nurses, pain~     specialists, anesthesiologists and other support staff. Postoperative components often~     involve multi-modal analgesia, early return to activity and early return to a regular diet.~     The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced~     pelvic surgery with a primary goal of decreasing narcotic usage.~   "
72252|NCT02111655|"~     All vascular access guidelines recommend monitoring and surveillance protocols to prevent~     vascular access complications in hemodialysis units.~      However, in the case of second generation screening techniques which determine access blood~     flow measurement (QA), there is a huge controversy about it´s efficiency.~      Although multiple observational studies find a decrease in the thrombosis rate and an~     increased primary assisted patency survival related to the use of these techniques, a~     recently published meta-analysis find contradictory results in the randomized controlled~     trials, affirming that the measurement of QA is useless in grafts and questionable in native~     arteriovenous fistulae (AVF).~      We have designed a multicenter, prospective, open label, controlled, randomized trial, to~     prove the usefulness of the QA measurement using two complementary second generation~     techniques, Doppler ultrasound and Transonic dilution method, compared to the classical~     monitoring and surveillance methods.~      The primary endpoint will be a reduction in the thrombosis rate with an increased assisted~     primary patency survival, and a cost effectiveness economic analysis.~      As secondary endpoints we will analyze the impact over non-assisted primary patency survival~     and secondary patency survival.~   "
72253|NCT02111642|"~     Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus~     and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant~     management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is~     the only option which potentially offers a cure.~      It is well known that women with pelvic organ prolapse are at risk of developing new stress~     urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined~     as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing,~     coughing, or laughing. Previous studies have demonstrated that the addition of a~     prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk.~     One example of such a procedure is a mesh sling placed underneath the urethra (midurethral~     sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary~     incontinence after prolapse surgery remains controversial.~      A new risk calculator tool has been developed to provide patients' with their individualized~     risk of developing de novo stress urinary incontinence after prolapse surgery. The primary~     objective of this study is to determine whether use of this new personalized online risk~     calculator tool increases patient satisfaction with the decision whether or not to have a~     midurethral sling placed at the time of prolapse surgery to prevent development of stress~     urinary incontinence. The investigators hypothesize that use of this tool will increase~     patient satisfaction with their decision regarding midurethral sling placement.~   "
72254|NCT02111629|"~     Genital tract infections (GTIs) have increased in the past decade and there is an~     association between sexually transmitted infections (STIs) and other infections like~     bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common~     causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the~     prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World~     Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative~     in places with no access to laboratory diagnostic tests.~      Justification. In patients with syndrome of vaginal discharge, an effective treatment~     against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced,~     therefore, for syndromic management of symptomatic vaginal discharge the combination of~     fluconazole and secnidazole could be used. No studies evaluating this combination were found~     in the literature reviewed.~      Objectives: To describe the safety and the clinical and microbiological efficacy of a single~     oral dose of a combined treatment with secnidazole + fluconazole for the syndromic~     management of symptomatic vaginal discharge.~      Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and~     safety of the combination of fluconazole and secnidazole for the treatment of symptomatic~     vaginal discharge. The participants will be sexually active women with lower genital tract~     symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral~     symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be~     conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive~     character of the study, no a priori hypothesis is considered. A consecutive convenience~     sample size of 100 symptomatic patients is calculated. The statistical analysis will be~     performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative~     frequencies and measures of central tendency and dispersion appropriate for the distribution~     of the variables will be calculated. The study has been submitted and approved by the Ethics~     Committee of the Faculty of Medicine of the National University of Colombia and the~     Institutional Review Board of the participating institution. All women must sign a written~     informed consent form agreeing to voluntarily participate in the study.~   "
72255|NCT02111616|"~     Purpose: Cancer survivorship is a high clinical and research priority both nationally and at~     the University of North Carolina. The investigators propose a randomized pilot study testing~     the development, implementation and evaluation of a parallel patient and streamlined~     provider version of a personalized Survivorship Care Plan (SCP) with lung cancer patients.~      Participants: 60 lung cancer patients at Rex Cancer Center.~      Procedures (methods): Participants will be recruited and randomized to the standard of care~     (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care~     will receive a tailored survivorship care plan at the end of cancer treatment. Patients~     randomized to the intervention will receive a care plan and coordinating visit with their~     primary care provider. Patients will be invited to complete baseline and follow-up~     assessments regarding care needs and confidence in post cancer care.~      All patient primary care providers will receive condensed provider versions of the care~     plan. Providers will be asked to evaluate how the SCP and coordinated care visit~     (intervention only) facilitated communication and coordination of care.~   "
72256|NCT02111603|"~     The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid~     excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of~     increased fecal 48 hour total bile acid excretion. The investigators aim to study the~     ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment~     with Colesevelam.~   "
72257|NCT02111590|"~     The aim of this study is to evaluate development of hemolysis and the variation in~     isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating~     polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)~        1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG)~          to weekly treatment with subcutanoeus immunoglobulin (SCIG)~        2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.~      Hypotheses~        -  During treatment with IVIG blood hemoglobin will fluctuate with a decline due to~          infusion, whereas it will remain stable during SCIG treatment without fluctuation~        -  Isokinetic muscle strength in affected muscle groups is more stable during treatment~          with SCIG than with IVIG~        -  Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or~          Hizentra® and Gammanorm® treatment~   "
72258|NCT02111577|"~     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care~     Chemotherapy can improve survival times for patients with Metastatic Castration Resistant~     Prostate Cancer.~   "
72261|NCT02111538|"~     Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin~     light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the~     prognosis predominantly depend on the presence and severity of cardiac involvement, it was~     shown that malnutrition is an independent predictor of survival and quality of life.~     However, the assessment of nutritional status by common indices based on anthropometry is~     not always feasible and accurate due to reduced performance status and/or the presence of~     fluid imbalances (for example edema and ascites). Several recent studies have demonstrated~     the prognostic value of the phase angle. Moreover, the value is supported by its~     applicability to patients who are bedridden or present alterations in the state of~     hydration.~   "
72262|NCT02111525|"~     The purpose of this study is to determine the distribution of lung fluid status as reported~     by the IMED-4 system in patients presenting to the emergency department or urgent care~     facility with shortness of breath.~   "
72263|NCT02111512|"~     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.~     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.~     There is robust data to support the safety of influenza vaccines (containing low or~     negligible amounts of egg protein) in patients with egg allergy.~      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently~     been approved by a number of licensing boards and is given by a spray into the nose. This~     new vaccine has been available in the United States for several years and is highly~     effective and against influenza infection, with an excellent safety profile in children~     without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and~     there are NO published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1~     Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.~      The objective of this multicentre study is to further assess the safety of intranasal LAIV~     in egg-allergic children, in order to demonstrate that these children can safely be given~     the new LAIV within a primary care health environment.~   "
72264|NCT02111499|"~     Clinical investigation of anti-psoriatic efficacy and atrophy~   "
72265|NCT02111486|"~     This clinical trial is being conducted to study whether eating certain meals will reduce~     your desire to eat and for a longer period of time compared to others and to determine the~     post-meal glucose response associated with each of these breakfast foods.~   "
72266|NCT02111473|"~     The study is designed to answer the following questions:~      1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.~      2/ What is the effect of testosteron replacement on the bone mineral metabolism.~   "
72267|NCT02111460|"~     This is a randomized parallel control trial to evaluate whether radical loco-regional~     Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal~     carcinoma.~   "
72268|NCT02111447|"~     Children who receive general anesthesia may become agitated (emergence delirium) in the~     recovery period. This occurs more often after inhalational anesthetics, particularly~     sevoflurane and desflurane than after propofol. However, agitation after anesthesia in~     children may be difficult to distinguish from pain; accordingly studies are ideally designed~     during MRI to obviate the contribution of pain during emergence. Airway complications have~     been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs.~     Whether the airway complications were due to the LMA or the isoflurane was unclear.~     Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane~     compared with IV propofol and 2. airway complications after LMA or nasal prongs.~   "
72269|NCT02111434|"~     The study is designed to answer the following questions:~        1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio~          in hypogonadism?~        2. What is the effect of testosterone replacement on the visceral adiposity index and~          Triglycerides/HDL cholesterol ratio?~   "
72270|NCT02111421|"~     Currently, spinal anesthesia is most commonly used for cesarean section.But spinal~     anesthesia can not block the visceral vagus nerve, and the patients are prone to nausea,~     vomiting, chest tightness or other discomfort when the uterus is stretched .For parturients~     who have poor uterine contractions and are bleeding larger, obstetricians often use oxytocin~     to strengthen the contraction of the uterine,which also would increase the parturients'~     discomfort.Anesthesiologists often intravenous sedative hypnotics (eg.propofol or midazolam)~     to alleviate the fear of the parturients after the baby is delivered.One of the side effects~     of propofol or midazolam is that they would lead to the respiratory depression.For the poor~     respiratory reserve of the parturients, functional residual capacity(FRC) of this group~     could be reduced by up to 20%, and the oxygen consumption was also increased.The SPO2 could~     decline quickly intraoperatively.Dexmedetomidine(DEX) is a novel , highly selective α2~     adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than~     α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition~     of sympathetic nerves and other effects.Because of its minimal impact on the respiratory ,~     it could safely and effectively used to sedate patients undergoing cesarean section.But the~     change of endocrine system and hemodynamic of the parturients may affect the~     pharmacokinetics and pharmacodynamics of some anesthetic drugs.Currently studies have~     demonstrated the increased sensitivity of some anesthetic drug in parturients, such as~     lidocaine and isoflurane.The study is aim to explore the optimal DEX dose to produce~     suitable sedation in parturients ,and compared with norman nonpregnant women.~   "
72271|NCT02111408|"~     The purpose of this study is to investigate sleep disordered breathing, autonomic~     dysfunction, and post stroke depression in acute and chronic stroke patients. Furthermore,~     to explore the interaction between these comorbidities, and their relation to stroke~     aetiology.~   "
72310|NCT02110888|"~     Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant~     proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage~     of low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity~     mark for the treatment of chronic refractory neuropathic pain and is now commonly used in~     some countries to target back pain. However, the potential value of combining SCS and PNS as~     hybrid stimulation remains poorly described with only isolated case reports or limited~     experience in various indications.~      The CUMPNS comparative randomized study is designed to demonstrate the potential analgesic~     efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain~     component pain in refractory FBSS patients.~   "
72272|NCT02111382|"~     Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue~     mobility/ motility dysfunctions in general, using different approaches (depending on the~     target tissue) known as osteopathic manipulative treatment.~      Among all the available techniques those ones addressed to the cranial field are most~     questioned because of the lack of scientific evidence; but the compression of the 4th~     ventricle technique has been largely studied in clinical trials. Studies have shown that the~     technique may affect both central and autonomous nervous system, modulating some reflexes~     (Traube-Hering baro signal), and modifying brain cortex electrical activity through central~     sensitization in subjects with chronic low back pain.~      Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak~     alpha frequency (electroencephalographic assessment) and promote physical relaxation in~     subjects in vigil.~   "
72273|NCT02111369|"~     Essential tremor is the most common adult-onset movement disorder, and essential voice~     tremor is the vocal manifestation of essential tremor. While nearly all essential tremor~     patients experience hand tremor, many also manifest head tremor and voice tremor. Essential~     voice tremor can lead to increased vocal effort, decreased intelligibility, and misconstrued~     emotional state. Only one medication, propranolol, is FDA-approved to treat essential~     tremor. Propranolol is not felt to be nearly as effective for axial tremors (head, trunk,~     neck) as it is for extremity tremors. However, this has not been studied with any objective~     assessment in a prospective way for EVT. For patients with essential voice tremor, the~     limited published data suggests that botulinum toxin has been shown to lead to functional~     voice improvement. Botulinum toxin, though also not well-studied with objective voice~     outcomes, is a commonly used clinical therapy for treatment of essential voice tremor. While~     it is used more often for essential voice tremor than propranolol therapy, botulinum toxin~     also has not been prospectively studied with validated, objective voice outcome measures.~     The investigators would like to determine if propranolol has any significant effect on vocal~     tremor. The investigators would also like to determine, in an objective way, the effect of~     botulinum toxin on vocal tremor. If effective, propranolol would provide an affordable and~     non-invasive alternative or addition to botulinum toxin injections for patients with~     essential voice tremor.~   "
72274|NCT02111356|"~     Pinhole glasses which is using pinhole effect may induce a functional change on the eyes,~     including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative~     amplitude, CS, Visual field(VF), Stereopsis.~   "
72275|NCT02111343|"~     The current study aimed to examine the effectiveness of a Computer-based auditory training~     (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by~     comparing the changes in auditory processing (AP) and functional listening skills of these~     children immediately post-intervention, to that of the untrained controls. The AP skills of~     the trained group were evaluated again at 3 months post-intervention to examine the~     sustainability of any improvements made from the CBAT intervention. I hypothesised that~     after intervention, children from the auditory training (AT) group would improve in their AP~     skills, and that improvement would be greater than the changes in AP skills of those~     untrained controls. I also hypothesised that the improvement made from the intervention~     would sustain for at least 3 months after the end of intervention. Finally, I examined if~     the training outcomes are predictable from any underlying factors such as the initial AP,~     language, or cognitive skills of these children.~   "
72276|NCT02111330|"~     Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240~     mg) after repeated (8 days) single daily oral dose administration in young male and female~     healthy subjects.~   "
72277|NCT02111317|"~     The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp)~     inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and~     tolerability of ASP015K administered alone and also and in combination with verapamil.~   "
72278|NCT02111304|"~     The primary hypothesis is that administration of iOWH032 to adult and pediatric males and~     females with acute cholera due to V. cholerae O1 reduces stool output in the first 24 hours~     significantly more than does the current standard of care.~   "
72279|NCT02111291|"~     The current trial examines the potential benefits of continuous 12 week treatment with~     Santyl, measured in terms of wound bed appearance. The visual appearance of granulation~     tissue will be recorded at each visit for the purpose of examining the relationship between~     wound bed appearance and progress towards healing. In support of this longer treatment~     regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was~     safe and well tolerated. Therefore, the present study is designed to test the hypothesis~     that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will~     result in more rapid development of granulation tissue than DFU treated with supportive~     care.~   "
72280|NCT02111278|"~     The purpose of this study is to determine if the addition of lumbar manipulation will~     improve function, decrease pain, and recurrence in adolescents with low back pain. The~     secondary aim of this study is to determine if a modification of a clinical prediction rule~     by Flynn will be effective in identifying adolescent patients with low back pain who would~     benefit from lumbar manipulation.~   "
72281|NCT02111265|"~     Compare the efficacy and safety of closed-loop target controlled infusion of propofol or~     etomidate at general anesthesia in geriatric patients~   "
72282|NCT02111252|"~     This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in~     healthy Japanese adult participants~   "
72283|NCT02111239|"~     The purpose of this study is to determine whether preoperative abdominal imaging using~     either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time,~     cost, and patient outcomes in DIEP flap breast reconstruction.~   "
72311|NCT02110875|"~     The purpose of this study is to learn more about balance and strength in an elderly~     population (60 and older). Data will be compared between controls and the age/gender-~     matched PD participants in study The Effects of vitamin D on Balance in Parkinson's~     disease (OHSU IRB # 6482). Specifically a t-test will be used to compare total work and~     total power on leg extension and flexion, composite SOT score conditions 1-3 and 4-6,~     response strength and latency on MCT, and turn duration from the iMOBILITY between the two~     groups.~   "
72324|NCT02110706|"~     The specific primary objective of this study is to determine whether rituximab is a safe and~     beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III~     efficacy trial.~   "
72284|NCT02111226|"~     Heart disease and stroke are the number one killers world-wide. When someone has~     hypertension, the constantly elevated blood pressure damages their blood vessels and the~     organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney~     failure and dementia. Finding and lowering high blood pressure to normal with lifestyle~     changes and if necessary medications, lowers the risk of these outcomes. Canada has high~     rates of blood pressure control compared to other countries in the world, due in large part~     to the successful dissemination of hypertension guidelines. However remote and disadvantaged~     communities have not been as successful and need additional measures to help achieve the~     same level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has~     extensive experience working with Canada's Aboriginal Communities and a large community in~     Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the~     implementation of guidelines-based blood pressure control and through partnerships with~     experts in government and industry, overcome barriers to lowering blood pressure in Canada's~     Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested~     that will close the circle of care around people with hypertension by bringing measurement~     data to the medical record and health care provider and also sending useful medical feedback~     to the person with hypertension via secure data servers and routine SMS messaging on cell~     phones. The system will be tested for effectiveness of diagnosing and also for managing~     hypertension. To begin the process of preventing hypertension, the team will also explore~     with an Aboriginal community how to create policies to reduce the sodium content in their~     food. If proven effective, DREAM-GLOBAL can also become a platform for managing other~     chronic diseases.~   "
72285|NCT02111213|"~     The primary aim of this research study is to evaluate the effectiveness of a computer-based~     'virtual lay advisor' intervention relative to a proven human lay advisor/promotore~     intervention to promote regular walking among inactive midlife and older Latino adults. The~     primary analysis is a non-inferiority analysis comparing these two interventions.~   "
72286|NCT02111200|"~     The investigators will study and compare how effectively sodium phenylbutyrate, sodium~     benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject~     participation will require three, separate, four-day study periods at least one week apart.~     During one study period (also called a treatment arm), subjects will take sodium~     phenylbutyrate; during another they will take sodium benzoate; during another they will take~     a combination of the two medications.~      We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate~     or a combination of the two.~   "
72287|NCT02111187|"~     This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label~     prospective clinical trial in men with localized high-risk prostate cancer undergoing~     radical prostatectomy.~      The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue~     from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy~     specimens to tumor tissue harvested at the time of prostatectomy.~   "
72288|NCT02111174|"~     The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will~     relieve chemotherapy induced peripheral neuropathy (CIPN).~      Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG)~     skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy~     machine directs electrical signals across the field to simulate non-pain information.~      Based on other studies, we think that we relieve pain with the Scrambler therapy device, but~     it has not been tested in a setting such as this one. This means that some of the pain~     relief could be due to placebo effect, or the CIPN pain going away on its own. In this study~     we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not~     use the electrical signals). We hope that this study will help us determine if the Scrambler~     device really helps patients with CIPN.~      Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for~     at least 3 months may be eligible to join this study.~   "
72289|NCT02111161|"~     The purpose of this study is to estimate the effect of intravenous polyspecific~     immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome~     measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing~     soft tissue infections (NSTI).~   "
72290|NCT02111148|"~     The investigators assess in this study the sensitivity of Urea and Creatinine and that of~     Nitrazine test in vaginal wash after injecting saline in the vagina of patients with~     pre-labour rupture of membranes~   "
72291|NCT02111135|"~     Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and~     impact on intestinal shedding of a single dose of monovalent high-dose inactivated~     poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated~     poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral~     poliovirus vaccine (b-OPV) to infants early in life~   "
72292|NCT02111122|"~     Sleep wake disturbance is a common problem in Parkinson`s disease patients and so far the~     therapeutic possibilities for symptomatic relief are limited. Small, open-label studies~     indicate that the use of Xyrem (gamma-hydroxybutyrate) might be of benefit in this~     situation.~      This study is intended to show a beneficial effect of the study medication in a randomized~     cross-over trial, that fulfills strict scientific criteria.~   "
72293|NCT02111109|"~     Haemorrhage following major trauma is an important preventable cause of death. Those~     patients who survive may have a prolonged period of debility caused by failure of key body~     organs. We suspect that an important contributor to this organ failure may be dysfunction in~     the network of small blood vessels that supply the bodies organs with oxygen and nutrients.~     Our study will examine the link between the microcirculation and organ failure in patients~     who have suffered significant bleeding after traumatic injury. We will also explore the~     relationship between resuscitation of the global circulation (blood pressure, cardiac output~     etc.)an area that is monitored in clinical practice with the state of the microcirculation,~     which by contrast is not monitored. Patients with severe traumatic injury commonly have~     problems with blood clotting. Some researchers have suggested that microcirculatory failure~     may be an important contributor to this problem and we will explore this in more detail.~     Finally, we will attempt to examine some of the mechanisms by which the microcirculation may~     be disrupted by trauma and subsequent bleeding. These may include inappropriate activation~     of white blood cells, inadequate function of oxygen carrying red blood cells and changes to~     the cells lining the small blood vessels.~      We will use a non invasive method to assess the microcirculation termed Side Stream Dark~     Field microscopy. This involves recorded a video image of the movement of blood within the~     small blood vessels under a patients tongue. In addition we will use ultrasound to assess~     the flow of blood from the heart. Small samples of blood will be taken to assess blood~     clotting and to look at possible mechanisms of microcirculatory dysfunction.~      We aim to study ten patients in the first instance. The study will be carried out within the~     intensive care units at Kings College Hospital.~   "
72294|NCT02111096|"~     The intent of this study is to assess the safety of LY2409021 in participants with Type 2~     diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal~     physician. The study treatment is expected to last 12 months (52 weeks).~   "
72312|NCT02110862|"~     The aim of this study is to evaluate scintigraphic methods as objective factors for~     functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The~     gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the~     functional outcome.~   "
72752|NCT02105064|"~     This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms~     in patients with schizophrenia.~   "
72297|NCT02111057|"~     Researchers at the Hospital for Special Surgery are trying to learn more about~     post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare~     after total joint replacement surgery and what the result of flaring is for patients over~     the next year. We will ask patients about their RA, whether it has gotten worse, and whether~     they are able to work with the physical therapist. During the course of this study, we'll be~     collecting questionnaires, and we'll be drawing blood to better understand what's going on~     with RA and with a patient's recuperation from their joint replacement.~      We want to understand whether a flare of RA might affect the outcome of a patient's joint~     replacement. We believe this study might show us how to better manage patients with~     rheumatoid arthritis following a joint replacement. If RA patients who flare are unable to~     participate in physical therapy and do worse after one year after a total hip replacement,~     more effective treatment could be developed. The study will also help us to identify early~     factors that may influence long-term outcomes of joint replacements in RA patients.~   "
72298|NCT02111044|"~     The purpose of this study is to investigate in acromegalic patients the effect of different~     doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability~     of three different doses of ITF2984.~   "
72299|NCT02111031|"~     The objective of the registry study is to demonstrate the clinical utility of the~     CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in~     the United States. The objective of the present registry is to demonstrate the impact on~     patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients.~     Hereto the hypothesis that the availability of CTC information provides clinicians~     important, timely information and impacts treatment decisions, will be tested.~      This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US,~     and is being used in accordance with its labeling.~   "
72300|NCT02111018|"~     Prospective, randomized non-blinded, controlled study to assess the feasibility of the~     CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring~     renal replacement therapy.~   "
72301|NCT02111005|"~     Apoptosis is an evolutionary form of physiological cell death. Studies suggest that~     apoptosis is involved in the pathogenesis of periodontal diseases. Human gingival~     fibroblasts (HGF) have an important role in the periodontal immune response. It is believed~     that HGF can be diminished and/or eliminated by means of apoptosis.~      Smoking is one of the most common risk factor of periodontal disease. Studies indicated that~     smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival~     fibroblast.~      The purpose of this study is to determine and to investigate apoptosis of HGF in gingival~     biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis~     or aggressive periodontitis.~      Eighty subjects will be invited to participate in this study. Patients will be allocated~     into four groups (20 patients each). Gingival biopsies will be obtained from the base of~     papillae during surgical treatment (open flap curettage) and will be examined by~     Immuno-histochemical analysis. Immune-staining will be done using p53 monoclonal mouse~     anti-human antibody.~   "
72302|NCT02110992|"~     The purpose of this research study is to test the safety of a chemotherapy drug called~     docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on~     recurrent head and neck cancer that is not surgically removable.~   "
72303|NCT02110979|"~     The objectives of this study are to compare measurements in knowledge of decision options,~     support for decision making, uncertainly in decision making, and clarity of values important~     to decision making among two groups of type 2 diabetes patients, those who receive a Patient~     Decision Aid and those who receive usual care.~   "
72304|NCT02110966|"~     The purpose of this study is to evaluate the success of inferior alveolar nerve block, after~     the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible~     pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine~     plus Tramadol in the same anesthetic technique and patients group.~      Hypothesis:~      Local application of mepivacaine plus tramadol increases the successful of inferior alveolar~     nerve block in patients with irreversible pulpitis.~   "
72305|NCT02110953|"~     This phase I trial studies the side effects and best dose of irinotecan-eluting beads in~     treating patients with colon or rectal cancer that has spread to the liver and does not~     respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that~     have been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in~     chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells or stopping them from dividing. This treatment~     delivers the chemotherapy directly to the tumor area inside the liver instead of to the~     whole body as with systemic delivery of the drug. Irinotecan-eluting beads may work better~     that standard chemotherapy in treating patients with colon or rectal cancer that has spread~     to the liver.~   "
72306|NCT02110940|"~     This clinical trial is the first study to apply neurodynamic mobilization, a nervous system~     specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the~     study is to find out the effect of neurodynamic mobilization for joint inflammation in~     patients with RA.~   "
72307|NCT02110927|"~     The purpose of this study was to analyze microcurrent short term effects used with aerobic~     exercise on abdominal fat.~   "
72308|NCT02110914|"~     The treatment burden for patients with cystic fibrosis (CF) is significant and poor~     adherence has been well-documented. The investigators hypothesize that a health coaching~     intervention will empower young adults with CF to manage their lives with CF and improve~     health-related quality of life (HRQoL). The main aim of the study is to establish the~     feasibility and acceptability of a Motivational Interviewing inspired coaching-intervention.~   "
72309|NCT02110901|"~     This research study is designed to assess the safety and effectiveness of an experimental~     drug called PRT-201 in patients both receiving or expecting to receive dialysis who have~     chronic kidney disease and who are undergoing surgery to create a new access point to their~     bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research~     studies to help keep vessels patent when applied to the outside surface of the blood vessels~     (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula~     (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited~     segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves~     the patency of your AVF.~   "
72314|NCT02110836|"~     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and~     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles~     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)~     levels. Both liver and muscle glycogen are important for the ability to perform~     intense/prolonged endurance exercise. Therefore, nutritional strategies which can maximise~     the availability of glycogen in muscle and liver can benefit endurance exercise capacity.~      The carbohydrates typically found in sports drinks are glucose and sometimes fructose. If~     glucose only is ingested during exercise, then the maximum rate at which can be absorbed~     from the intestine into the blood stream is ~1 g/min. However, if different sources of~     carbohydrate (fructose) are used, which are absorbed through a different pathway, absorption~     of carbohydrate can be up to ~1.8 g/min. With more carbohydrate available as a fuel, this~     translates into an improvement in performance.~      Sucrose is a naturally occurring sugar that is made up of a single glucose and single~     fructose molecule. Therefore, theoretically, this can use the two different pathways of~     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact~     this has on our liver and muscle glycogen stores during exercise. Therefore the aim of this~     study is to assess whether sucrose ingestion influences liver and muscle glycogen depletion~     during endurance exercise.~   "
72315|NCT02110823|"~     The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle~     heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in~     the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig~     shunt (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).~      The purpose of this study is to learn if children (2-6 years of age) who were enrolled in~     the SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after~     surgery.~   "
72316|NCT02110810|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for~     treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis~     represents the most common and feared complication following ERCP. The reported incidence of~     this complication is from 1% to 40% according to the presence of high-risk factors for this~     complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective~     series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk~     patients, respectively. Independent risk factors for post-ERCP pancreatitis are either~     patient- or procedure-related.~   "
72317|NCT02110797|"~     Based on our clinical observations, many girls with RETT syndrome, a severe~     neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very~     early age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few~     epidemiological studies have estimated the frequency of osteoporosis in girls with RETT~     syndrome and showed that they are more exposed then children with other neuro-developmental~     diseases with a same degree of neurological handicap. However, the mechanisms that lead to~     early osteoporosis in RETT syndrome remain unknown. Mutations in the MECP2 gene are found in~     95% of RETT patients and preliminary experimental studies have shown that this can lead to~     abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone~     remodelling by interacting with RANK-ligand.~      In order to identify risk factors of osteoporosis in RETT syndrome and to understand the~     pathophysiological mechanisms the study protocol includes:~        1. Clinical evaluation of bone health (history of bone fractures, pain, nutritional~          status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking~          ability, vitamin D satus)~        2. evaluation of the mineral density at the lumber spine using DEXA~        3. measuring concentrations of osteoprotegerin and RANK-ligand~   "
72318|NCT02110784|"~     The aim of the present study is to investigate the efficacy, safety and tolerability of a~     therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by~     P. vivax in endemic countries.~   "
72319|NCT02110771|"~     Social cognition impairments was highlighted for persons suffering with schizophrenia by~     numerous studies. The use of treatment programs intended to treat specifically these~     deficits through procedures of cognitive remediation, will allow decreasing their impact on~     everyday life by improving abilities to understand and interact with others. Such tools~     could allow also profits in terms of reduction of positive and negative of schizophrenia.~     The Gaïa program is intended to improve the perception of the facial affects which is one of~     social cognition processes impaired in schizophrenia.~      Methods:~      This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years~     with a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of~     Mental disorders, 4th edition (DSM-IV-TR).~      The GAÏA program will be compared to an already validated neurocognitive remediation~     program, training attentional processes (RECOS).~      100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist,~     computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted~     method)~      Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation~      Hypothesis:~      A targeted cognitive remediation will more increased abilities in facial affects recognition~     processes than a non specific, attentional cognitive remediation.~      Primary outcome measures:~      - Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after~     10 weeks and 20 session of treatment.~      Secondary outcome measures~        -  Change from baseline in clinical, psychosocial, social cognition and neurocognitive~          measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.~        -  Change from baseline in performances in the Facial Emotion Recognition Task (TREF)~          after treatment and 6 months follow-up.~   "
72320|NCT02110758|"~     The National Committee for Quality Assurance has worked with the National Coalition for~     Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management~     Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory~     group, to define the Patient-Centered Oncology Care model. The purpose of this project is to~     pilot and evaluate this model. Specific research questions are:~        1. Does Patient-Centered Oncology Care improve patient experiences and quality of care?~          Does it reduce undesirable events like emergency department visits and hospital stays?~        2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices~          and what factors affect adoption?~      The demonstration will take place in oncology practices in southeastern Pennsylvania.~     Practices will receive implementation support during the 24-month demonstration period. They~     will be evaluated using patient surveys, quality measures, and measures of emergency~     department and hospital use. Results from these practices will be compared in two ways: 1)~     with their performance before they became oncology medical homes and 2) with other similar~     practices.~   "
72321|NCT02110745|"~     The objective of this study was to determine (a) whether patients anesthetized with~     intravenous propofol have less pain compared with sevofluorane for paediatric inguinal~     hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has~     better quality of recovery compared with sevofluorane anesthesia in the immediate~     postoperative period after paediatric inguinal hernia and undescended testis operations.~   "
72326|NCT02110680|"~     Overactive bladder (OAB) is a very common problem that impairs the quality of life of about~     17% of adult population in USA above the age of 40. The issues becomes more prominent with~     getting older. OAB was determined by International Continence Society as urgency (immediate~     desire to urinate that could not be postponed) with or without incontinence usually~     associated with increased frequency and nocturia (urination at night). In 2012, American~     Urologic Association published clinical guidelines for the treatment of OAB of non~     neurogenic origin. Neuromodulation was proposed as the third line of treatment and two~     treatments were recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve~     stimulation (PTNS). Each of above mentioned procedures are invasive. SNM involves lead~     implantation in operating room using X-ray guidance and anesthesia. PTNS involves needle~     insertion on the low extremity.~      The investigators would like to examine the efficacy of transcutaneous nerve stimulation~     (TENS) in refractory to the first two lines of OAB treatment patients.~   "
72327|NCT02110667|"~     This study is being done to find out if transperineal ultrasound (TPUS) can help define the~     prostate bed for radiation treatment planning and improve upon current methods of image~     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement~     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they~     are lying on their back in the position they will receive their treatment. Image-guidance is~     required for the treatment of prostate cancer because the prostate bed shifts position~     depending on how full the bladder and rectum are. Image-guided radiation therapy has been~     done at Fletcher Allen Health Care for approximately three years. Most commonly,~     transabdominal ultrasound images are obtained every day and compared to an ultrasound that~     was done on the day of treatment planning. Adjustments in radiation field position can be~     done on a daily basis by comparing these images. Transperineal ultrasound has never been~     used for image-guidance. We completed two phases of an earlier study and have developed a~     TPUS device and process that allow us to get clear ultrasound pictures of the prostate~     gland, and now we would like to explore imaging the prostate bed left after radical~     prostatectomy.The TPUS has three potential advantages over the transabdominal method we~     currently use:~        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get~          clearer images, however it is difficult for some men with prostate cancer to~          comfortably keep a full bladder. It is also particularly difficult to get good images~          in larger men who have long distances from the skin surface to the prostate bed. TPUS~          is not dependent on a man having a full bladder and should be less dependent on the~          size of the man.~        2. TPUS images and the planning CT images can be acquired simultaneously. This is not~          possible with the abdominal probe because it gets in the way of the CT machine.~          Simultaneous imaging eliminates the possibility of the prostate bed shifting positions~          during the time between imaging studies.~        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe~          gets in the way of the treatment machine) and may in the future allow us to watch the~          prostate bed during treatment. If we discover that we can accurately view the prostate~          bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields~          and possibly decrease the risk of radiation complications.~      Patients in this study will be treated for their prostate cancer with the standard image~     guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In~     addition, one TPUS scan will be acquired at the time of the initial simulation.~      To summarize, the two objectives of this study are:~        1. To determine if TPUS can acquire usable, clinically pertinent IGRT images of the~          prostate bed.~        2. To preliminarily compare TPUS images of the prostate bed to images obtained with CT and~          TAUS.~   "
72328|NCT02110654|"~     1. objectives. To compare the efficacy and the safety of mometasone furoate nasal spray~          (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair~          10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic~          sinus surgery (FESS) for improvement the clinical control of CRS~        2. the clinical hypotheses. The investigators hypothesize that postoperative combined~          montelukast and MFNS can better improve clinical control of CRS concomitant with asthma~          after FESS compared with MFNS alone.~        3. study design This study is a 9-month randomized, open-label, controlled interventional~          study.~   "
72329|NCT02110641|"~     The specific aims of this study are to determine the efficacy and cost-effectiveness of a~     weight loss program compared with usual care (control) treatment on 6-month changes in body~     weight, body fat, serum hormones, and breast tissue markers associated with prognosis in~     breast cancer survivors.~   "
72330|NCT02110628|"~     Gastric is one of the most prevalence digestive malignance tumors in China. Radical~     resection of primary tumors and combine with dissection of regional lymph-nodes is~     acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of~     life, controversies still exist to the reconstruction methods of total gastrectomy. Although~     roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an~     easily and safety method reconstruction method, but some problems still need us to solve,~     such as little food reserves, less food intake per meal and fast gastric emptying. These~     problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal~     pouch anastomosis is newly born method can significant increase the volume to improve~     postoperative quality of life have been proven by some little sample size randomized control~     trail With the improvement of the gastric cancer surgery, this study proposed by prospective~     randomized controlled clinical trials aimed to comparing quality of life after traditional~     Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy.~     Quality of life was evaluated according to the European Organization for Research and~     Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality~     of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months~     after gastrectomy.~   "
72331|NCT02110615|"~     Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford,~     Massachusetts that incorporates evidence-based interventions across multiple sectors and at~     multiple levels. The overall goal of the study is to examine the extent to which the~     comprehensive, systematic intervention reduces childhood obesity among underserved children.~      The clinical intervention implements evidence-based interventions each city's~     federally-qualified community health center. Intervention components aim to improve primary~     and secondary prevention of childhood obesity and implement changes at four levels:~     clinician; parent-family; organizational; and environmental. We additionally provide~     training and educational materials to other pediatric clinicians in the two communities. The~     clinical intervention components include (1) advanced training on clinical quality~     improvement and obesity prevention, assessment, management; (2) computerized, point-of-care~     decision support tools for clinicians; (3) implementation of multi-disciplinary weight~     management programs within the community health centers, e.g. Healthy Weight Clinics (HWC);~     (4) integrating community health workers into the primary care and HWC teams; and (5) health~     center environmental changes to support behavior change modification.~   "
72332|NCT02110602|"~     The investigators are conducting this research study to find out if eating low or high~     levels of specific amino acids changes the levels of these same amino acids in the blood.~     Amino acids are the building blocks of protein that are normally found in food. The amino~     acids the investigators are studying are called branched chain amino acids. The~     investigators will look at the levels (amount) of branched chain amino acids in blood before~     and after consumption of specially prepared meals. The investigators hypothesize that~     circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content~     diet compared with a high BCAA-content diet.~   "
72333|NCT02110589|"~     Epilepsy is an episodic disorder which can result in recurrent seizures often associated~     with hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia~     can often occur before full expression of the seizure and so detection of hypertonia could~     act as an alarm to epilepsy patients and carers in order to prepare for a seizure event.~     Secondly, a recording device for seizure frequency and duration is a valuable clinical tool~     for collecting data for clinicians who manage the disorder in primary and tertiary care. The~     investigators have developed a portable prototype for hypertonia detection using a~     non-invasive, muscle activated, sensor that records seizure activity. The investigators now~     want to test this sensor system in patients identified by Consultant Clinician Custodians~     within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been~     developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.~   "
72334|NCT02110576|"~     CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty~     normal donors to create reference intervals for various Haemonetics reagents. Venous blood~     from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be~     drawn at the study site to account for aberrant or outlying data excluded for technical or~     other reasons.~   "
72335|NCT02110563|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid~     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to~     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor~     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell~     growth.~   "
72336|NCT02110550|"~     Background: no randomized controlled trial has tried to compare treatment outcomes between~     the IPS.emmax endocrowns and the IPS.emmax conventional crowns .~      Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the~     IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled~     trial on patients with one or more intensive damaged molars requiring crowning and being~     treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be~     examined at the baseline assessment using a modified US Public Health Service (USPHS)~     criteria.~      Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be~     examined to find any excessively damaged molars requiring crowning. Forty patients will be~     recruited according to specific inclusion criteria. Randomization will be performed using~     computer-generated tables; allocation will be concealed using sequentially numbered opaque~     and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60~     years). They will be randomly distributed into two groups with 20 patients in each group~     (1:1 allocation ratio).~      Intervention: Excessively damaged and endodontically treated molars will be restored with~     IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.~      Main outcome measure: marginal adaptation and anatomic form will be investigated clinically~     and by apical radiographs at the baseline assessment using the modified (USPHS) at six~     assessment times during an 18-month observation period.~      Assessor blinding will be employed.~   "
72337|NCT02110537|"~     The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial~     fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients~     resistant to the antiarrhythmic drugs (AADs).~   "
72338|NCT02110524|"~     The purpose of this study is to assess safety and the inhibition of restenosis of the CVI~     Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or~     reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.~      The primary endpoint for this analysis is late lumen loss at six (6) months.~   "
72339|NCT02110511|"~     The aim of this study is to determine the effects of bean physical form (whole versus~     blended) and Beano on postprandial responses. The postprandial responses the investigators~     will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood.~     To accomplish this aim the investigators will conduct a randomized, placebo-controlled trial~     in overweight and obese but otherwise healthy (non-diabetic) men and women~   "
72340|NCT02110498|"~     This research is being done to learn more about pancreatic cysts. The tests that are~     currently available are imperfect at determining exactly what type of pancreatic cyst a~     person has, which cysts contain cancer, or what the risk is of developing cancer in the~     future. The aim of this study is to use a combination of clinical, imaging, cyst fluid~     analysis, and molecular markers to try to help develop better tools to answer these~     questions.~   "
72341|NCT02110485|"~     The purpose of this study is to determine if a patient activation tool (PAT) can improve~     decision making and patient centered outcomes in pediatric patients with appendicitis and~     their caregivers choosing between antibiotics alone and appendectomy.~   "
72342|NCT02110472|"~     The Presbia Flexivue Microlens is a corneal inlay.~   "
72343|NCT02110459|"~     To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function~     impairment after single intravenous (IV) infusion of POL7080~   "
72344|NCT02110446|"~     To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS)~     patients.~   "
72345|NCT02110433|"~     Heart failure is a serious and common disease. HF is marked by a high rate of preventable~     hospitalizations through proper care. As such, it is a key target for telemedicine programs.~     However, currently published data are inconclusive. Investigators propose a multicenter~     randomized study of innovative telemedicine involving the usual patient monitoring daily~     weight monitoring, clinical signs and in one of three groups in our study of BNP testing in~     the patient's home all associated with a regular education reinforcement. The objective is~     to identify early cardiac decompensation to allow to treat ambulatory and thus prevent the~     occurrence of more serious events such as death or rehospitalization.~   "
72346|NCT02110420|"~     First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and~     multiple ascending doses of CC-90001~   "
72347|NCT02110407|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine~     the underlying neuronal mechanism.~   "
72348|NCT02110394|"~     Prospective multicenter observational non-interventional study to assess routine clinical~     practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia~   "
72349|NCT02110381|"~     An estimated 76 million adults in the United States over the age of 20 have hypertension~     (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25%~     for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the~     population together with increases in obesity and sedentary behavior, it is not surprising~     that HTN is projected to increase significantly over the next several decades; with over 1.5~     billion adults having HTN by the year 2025. Thus the public health implications to~     preventing and/or reducing elevations in blood pressure are substantial.~      This study compares the efficacy of two different non-pharmacologic interventions (device~     guided breathing and isometric hand grip exercises) used alone and in combination for~     lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension.~     The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary~     outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the~     interventions by participants. The knowledge gained from this study can provide information~     on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge~     may be especially useful for patients for whom access to medications and health care is~     limited and among patients unwilling to take or intolerant to pharmacologic therapies.~   "
72350|NCT02110368|"~     Bioequivalence study comparing the rate and extent of testosterone absorption for a test~     formulation versus the reference product.~   "
72351|NCT02110355|"~     Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in~     combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by~     a direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib~     combined with dabrafenib alone.~   "
72352|NCT02110342|"~     The study aims to understand, using radiolabelled PF-04449913, how this compound is modified~     by the body once it is absorbed. The study also aims to understand how much of the compound~     is broken down and how much leaves the body unchanged.~   "
72353|NCT02110329|"~     Lymph node involvement remains the main criteria for postoperative chemotherapy in patients~     with colon cancer (CC) without distant metastasis. To date, the prognostic value of the~     somatic quantitative molecular alterations such as loss or gain of genomic region is not~     established in CC.~      AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR~     of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the~     simultaneous detection of main quantitative somatic alterations in stage II-III CC.~      Patients and Methods. We enrolled and collected all baseline characteristics of patients~     operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a~     simultaneous amplification of 9 selected target genomic sequences from literature: DCC~     (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2~     (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3).~     Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral~     tissue allowed us to identified gain or loss genomic region. The primary end-point was the~     local and/or distant recurrence and relation between clinical and single or combined~     molecular alterations and recurrence were evaluated.~   "
72354|NCT02110316|"~     The objective of this study is to obtain the absolute bioavailability of voriconazole in~     critically ill ICU patients, because pharmacokinetics can be different in critically ill~     patients due to alterations in function of various organs and body systems compared with~     healthy volunteers.~   "
72355|NCT02110303|"~     Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the~     wall of heart blood vessels. It appears that this process can also frequently occur without~     causing any symptoms and these events likely explain the development of narrowing within the~     heart arteries which can subsequently produce symptoms of angina (chest pain).~      Previous research has shown a specialised scanner known as a PET (positron emission~     tomography) scan can identify these recently ruptured plaques in patients without symptoms~     of a heart attack and these patients have changes on a blood test (troponin) which suggest~     that they are at higher risk of having a heart attack in the future. This study aims to~     identify these patients using the PET scan and then see if the markers of increased heart~     attack risk can be reduced by the use of a blood thinning medication (ticagrelor) which is~     already a well recognised treatment for people who have suffered a recent heart attack.~   "
72356|NCT02110290|"~     This study is assessing quality of life in children with a physical disability who~     participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where~     children with physical disabilities are able to participate in more organized sports and~     active programs with the use of adaptive equipment. This study would assess a child's self~     reported and parent perceived quality of life before and after child participation in HSP~     for the winter season. The investigators aim to determine the level of child and parent~     happiness and satisfaction in specific quality of life aspects including: physical~     activities and health, feelings, moods, self perception, home life, friends, school,~     learning and bullying. The investigators believe that children with any physical disability~     will have a more satisfactory reported quality of life after participating in HSP for one or~     many years.~   "
72357|NCT02110277|"~     The purpose of this study is to develop technology to image the ovaries in order to better~     evaluate ovarian disease and to study how these experimental imaging techniques might work~     together or separately to improve our ability to detect ovarian cancer.~   "
72358|NCT02110264|"~     The aim of this trial is to assess the clinical utility, effectiveness, and cost~     implications of treatment for incarcerated offenders with opioid use disorders who are~     randomly assigned to one of three treatment conditions to include a depot formulation of~     naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a~     patient navigator (PN) XR-NTX+PN, and a drug education procedure (ETAU) before being~     released to the community. This trial will investigate whether effective medication therapy~     used in non-incarcerated populations will also be effective in incarcerated individuals.~     Empirical evidence demonstrates that starting treatment before release greatly increases the~     probability of successful outcome including reduced alcohol and drug use, increased~     employment rates, and reduced recidivism rates.~   "
72753|NCT02105051|"~     The purpose of this study is to establish Chinese neonatal network to investigate current~     situation of neonatal birth weight and related factors. We investigated the risk factors~     such as sex, gestational age, region, nation, altitude, place of residence, maternal~     occupation, education level of mother, maternal age, maternal pregnancy diseases and~     multiple births.~   "
72359|NCT02110251|"~     Patients with peripheral arterial disease with symptoms of critical ischemia or reduced~     tissue loss have a very high mortality and morbidity rate. So far, treatment strategies~     focused on the preservation of life and limb by an open surgical or endovascular~     revascularization, together with cardiovascular risk management and pain relief. Important~     modifiable factors related to mortality and morbidity are not covered in the current~     national and international guidelines. This study investigates the effects on mobility,~     mortality and quality of life with supplementation of the standard treatment of critical~     limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by~     intensive risk factor management and lifestyle coaching will be taken in to account. The~     supervised exercise therapy will take place under the supervision of a trained~     physiotherapist.~   "
72360|NCT02110238|"~     The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular~     injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief~     of knee OA.~   "
72361|NCT02110225|"~     The primary objective of the study is to assess the safety and tolerability of two dose~     regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered~     over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The~     secondary objective of this study is to attempt to show a dose response by assessing the~     potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of~     visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will~     be monitored to determine if there is evidence of a persistent biological effect after~     discontinuation of the study treatment.~   "
72362|NCT02110212|"~     The objective of this study is to evaluate the safety and efficacy the OptiMedica~     Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two~     surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be~     evaluated by comparisons to the standard surgical procedure of continuous curvilinear~     capsulorhexis (CCC) and ultrasonic phacoemulsification.~   "
72363|NCT02110186|"~     The purpose of this study is to compare safety and outcomes of the following treatments of~     lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of~     (2) discectomy alone or (3) discectomy with internal fixation and fusion.~      Discectomy with posterior dynamic stabilization is proposed as the most effective treatment~     to improve range of motion, and to be similarly effective to discectomy alone and discectomy~     with internal fixation and fusion for other functional outcomes after surgery.~   "
72364|NCT02110160|"~     The purpose of this study is to assess the utility of FDG PET/CT in evaluating response of~     bone dominant breast cancer to therapy. Eligible patients with bone dominant ER+ breast~     cancer will undergo baseline FDG PET/CT for evaluation of their disease, after the start of~     therapy they will undergo an FDG PET/CT scan at 4 weeks and again at 12 weeks. PET/CT~     results will be compared to clinical measures of response, time to progression and overall~     survival.~   "
72365|NCT02110147|"~     This protocol has two parts - the Main Study which is 42 days in length and the Treatment~     Extension Study which allows the patients who complete the Main Study to continue receiving~     treatment with uridine triacetate. The purpose of this study is to replace oral~     administration of uridine with oral administration of uridine triacetate in patients with~     hereditary orotic aciduria who have received (or would reasonably be expected to receive)~     clinical benefit from treatment with exogenous uridine. It is also to document the continued~     clinical benefit of exogenous uridine when patients are switched from oral administration of~     uridine to oral administration of uridine triacetate.~   "
72366|NCT02110134|"~     The purpose of this study is to compare a hydroquinone skin care regimen alone to a~     combination of Revlite Laser treatment with a hydroquinone skin care regimen for the~     treatment of melasma.~   "
72367|NCT02110121|"~     The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the~     treatment of unwanted tattoos.~   "
72368|NCT02110108|"~     The purpose of this study is to evaluate the effects of the Revlite Laser System for~     treatment of facial solar lentigines~   "
72369|NCT02110095|"~     The purpose of this study is to evaluate the Picosure Laser System for the treatment of~     unwanted tattoos.~   "
72370|NCT02110082|"~     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose~     of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal~     Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.~   "
72371|NCT02110069|"~     In this research study we want to learn more about which treatment works better for patients~     diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high~     risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help~     your blood clot called platelets become trapped in the tumor causing swelling, pain, and~     bruising. Vascular tumors can be life threatening. There are few medical treatments that~     will work to shrink the vascular tumor. Some doctors will use steroids and vincristine to~     try and shrink vascular tumors.~      In this research study, the study doctor will compare two different drugs to see which one~     will work better to help shrink your vascular tumor. One of the drugs is vincristine.~     Vincristine is approved by the Food and Drug Administration (FDA) to treat people with~     cancer. Vincristine is used to stop the abnormal cells from growing such as cells that make~     up blood vessels.~      The other drug to be used in this study is sirolimus. Sirolimus is currently approved by the~     Food and Drug Administration (FDA) to prevent transplanted organ rejection. Sirolimus is not~     approved by the FDA for treatment of vascular abnormalities and is considered experimental.~     Sirolimus belongs to a class of drugs call 'mTOR inhibitors'. mTOR (mammilian target of~     rapamycin) helps cells to grow and may also help blood vessels to grow in a more normal~     fashion. Sirolimus is currently being tested in patients with vascular tumors and cancer. In~     vascular tumors, we hope sirolimus will stop the blood vessel growth.~      Funding Source: FDA - OOPD (Office of Orphan Products Development)~   "
72372|NCT02110056|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine~     the underlying neuronal mechanism.~   "
77963|NCT02036918|"~     This study aims to evaluate patients with metastatic castrate-resistant prostate cancer~     (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune~     activation in lymph nodes and peripheral blood.~   "
72374|NCT02110030|"~     Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical~     nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality~     and to reduce perceived pain in patients with subacromial impingement syndrome (SIS).~     Design: Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were~     randomly assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years).~     Patients in both groups received fifteen 30-min sessions of the assigned treatment for a~     period of 3 weeks. Before and after the treatment, shoulder pain was measured using a 100-mm~     visual analog scale and shoulder functionality was measured using the Constant-Murley scale.~   "
72375|NCT02110017|"~     An impairment in social cognition in schizophrenia could account for the severe professional~     and social difficulties among patients. Social cognition is the way the social world is~     understood, perceived and interpreted. It includes all the process than enable oneself to~     interact with another person, namely emotion perception and processing, theory of mind~     (ToM), social perception, social knowledge and attributional style. Since these process are~     interconnected, social cognition should be investigated through ecological tasks which~     activate all of them together. Developing a social cognition ecological task, then testing~     the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the~     main objective of this study. The secondary objective is to seek a functional deficit among~     the neural network of social cognition in patients with schizophrenia compared with healthy~     subjects.~      Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will~     be included. The social cognition paradigm will be developed and the fMRI activations will~     be compared to those of a visual cartoon based task, known to turn on the neural network of~     ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored~     and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month~     later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).~      Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included~     to test the secondary objective. We make the hypothesis of a fMRI functional alteration in~     the cerebral network involved in social cognition, especially in the medial prefrontal~     cortex, among patients compared with healthy subjects.~   "
72376|NCT02110004|"~     The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV~     Catheter's ability to collect intracardiac signals within the desired chambers (atrial~     and/or ventricle) in the heart for the analysis of complex arrhythmias.~   "
72377|NCT02109991|"~     The purpose of this study is to evaluate the CG-100 device, a single use, temporary~     intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic~     site, following colorectal surgery (open or laparoscopic).~   "
72378|NCT02109978|"~     This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D)~     therapy using a retrospective approach and patients with slow or fast diabetes progression.~   "
72379|NCT02109965|"~     Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day~     mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to~     44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed~     diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and~     resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective~     α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies~     suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it~     can reduce the mortality of endotoxemic rats and patients with severe sepsis. The~     investigators will conduct two animal studies and one clinical trial to investigate the~     effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with~     endotoxemia and patients with severe sepsis and septic shock.~      Sixty patients with severe sepsis and septic shock will be enrolled and randomized to~     control group or dexmedetomidine group. In the control group, the patients will be treated~     according to the clinical practice guideline. If sedation is required, non-dexmedetomidine~     sedative agents will be used. In the dexmedetomidine group, the patients will be treated~     according to the clinical practice guideline, and they will also receive continuous infusion~     of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed.~     The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil~     Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at~     preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of~     28-day and 90-day will be recorded and analyzed.~   "
72380|NCT02109952|"~     The purpose of this study is to monitor fracture risk associated with bone tumors in cancer~     patients.~      Previous studies from our lab have suggested that it is possible to compute the mechanical~     strength of bones with tumors using computed tomography (CT) scans, which are like~     three-dimensional X-ray pictures of the affected bones.~      The next step in determining the usefulness of this type of strength analysis is to see if~     we can accurately predict who is at risk for bone fracture and which patients are at high~     risk of fractures.~      This non-invasive analysis may help physicians determine the best treatment to reduce the~     risk of an impending bone fracture in the future.~   "
72381|NCT02109939|"~     Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as~     judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline~     to end of Week 8 of the study.~   "
72392|NCT02109796|"~     Previous studies show that one session of tDCS allow to improve muscle strength in~     hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale~     stimulation opposite to the cortical representation area of the injured hemisphere and a~     simultaneous stimulation opposite to the homonyme the cortical representation area of the~     healthy hemisphere. This approach seems to be the best relevant electrods configuration in~     order to restore the inter-hemispheric balance.~      We hypothesis that one session of tDCS with this electrods configuration allow to improve~     paretic quadriceps strength in hemiparetic patients after stroke.~   "
72403|NCT02109653|"~     This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and~     safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib~     (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or~     IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous~     systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.~   "
72382|NCT02109926|"~     The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45~     years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental~     factors, especially during critical periods of development, is strongly suspected. Reliable~     data on environmental exposure during this critical period are sparse.The discordant~     findings and the limitations of available studies underline the importance to conduct~     studies with sufficient statistical power to detect risk due to exposures during critical~     windows of vulnerability.~      We conduct a multicentric case-control study to assess this association. Cases and controls~     will be enrolled during a 18-month period. They will be interviewed by professional~     telephone interviewers about their occupational and residential history and about their~     domestic exposure to pesticides and other nuisances.~      An optional biological study to assess genetic polymorphisms known to be associated with~     testicular cancer will be proposed to every cases and controls.~      Mothers (or close relative) of cases and controls will also be contacted (with son's~     agreement). If they agree to participate, they will also be interviewed about antenatal and~     early life exposure of their sons to pesticides and other nuisances.~      Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and~     on recruiting center.~   "
72383|NCT02109913|"~     The purpose of this study is to determine whether biomarkers could be found to gain more~     insight in tumor characteristics in order to predict which patients will have a high chance~     of a long progression-free survival. Postmenopausal patients with advanced metastatic breast~     cancer who have progressed on anastrozole or letrozole will be eligible for this study.~   "
72384|NCT02109900|"~     This observational study aims the potential role of serum progesterone levels on the day of~     oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF~     cycles.~      There has been evidence, that increased serum levels of progesterone on triggering day are~     associated with a decreased probability of pregnancy after IVF.~      There is no study that investigate assocation between serum progesterone levels on the day~     of oocyte pick-up and IVF outcomes. This study will be the first in this case.~   "
72385|NCT02109887|"~     PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in~     immunocompromised patients including HIV-infected patients, transplant recipients, and~     immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of~     co-infection with CMV. In this difficult clinical situation, physicians have difficulty to~     decide on whether anti-CMV treament will help patients with any evidence of CMV~     co-infection. However, there is no objective test to differentiate true co-infection of CMV~     from innocent bystander of CMV in those with PCP. The investigators thus evaluate the~     usefulness of CMV-specific ELISPOT assay in patients with PCP to differentiate true~     co-infection of CMV from inocent bystander of CMV. This findings may guide physicians to~     decide anti-CMV treatment in patients with PCP and CMV co-infection.~   "
72386|NCT02109874|"~     This Phase I study will be conducted as a randomized, placebo-controlled, double-blind,~     dose-escalation study in four groups of healthy adult male and female subjects who are~     BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will~     be conducted at one or two sites located in South Africa. The purpose is to evaluate the~     safety and immunogenicity of two injections of AERAS 404 prepared with four escalating~     amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated,~     HIV-negative, and have no evidence of tuberculosis infection.~   "
72387|NCT02109861|"~     The purpose of the study is to identify specific genes that are up- or downregulated in~     multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib~     (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned~     standard myeloma treatment and will be given two hours prior to standard treatment. Blood~     samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.~   "
72388|NCT02109848|"~     A prospective observational study on keratoconus and post-keratoplasty will be conducted. We~     will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The~     Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These~     scans will be used to measure corneal thickness (pachymetry), corneal topography (anterior~     and posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will~     also be used when they become available. A comprehensive eye examination, Placido-ring~     corneal topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed~     for comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by~     regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by~     standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze~     formation.107, 108 In these cases PRK will be performed according to the standard of care~     and will not be a part of the study protocol. The postoperative results will be observed at~     the 3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography,~     ultrasound pachymetry, and Scheimpflug camera imagery~   "
72389|NCT02109835|"~     The purpose of the study is to identify a sub-group of diabetic patients at higher risk of~     progression of coronary disease and also more likely to suffer from heart attack/angina and~     heart failure. The total number of patients to be recruited in this study will be 250 with~     type-2 diabetes but no known heart disease. These patients will have an objective measure of~     the function of the lining of the arteries, CT scan of the arteries of the heart and an~     ultrasound scan of the heart and arteries of the neck done at baseline along with blood~     tests for identification new markers of malfunction of the lining and inflammation of the~     arteries. Patients will be followed up at 18 months. During the follow-up visit, in addition~     to the blood tests, the CT scan of the heart arteries and ultrasound of the heart and~     arteries of the neck will be repeated to assess progression of the non-calcified, calcified~     and mixed plaques in the coronary arteries.~   "
72390|NCT02109822|"~     The goal of this research study is to better understand current treatment practices for~     pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient~     Registry (CFFNPR)can be used for this type of study.~   "
72391|NCT02109809|"~     This phase I trial studies the side effects and best dose of low-dose total lymphoid~     irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has~     not responded to treatment with steroids. LD-TLI is a procedure in which all of the body's~     major lymph nodes are treated with small doses of radiation in order to reset the~     dysfunctional immune system. LD-TLI may work as a treatment for graft-versus-host disease~     caused by a bone marrow or stem cell transplant.~   "
72393|NCT02109783|"~     Numerous studies have investigated the effect of caffeine on athletic performance, but the~     findings have not been consistent. This is due, in part, to the differences in response that~     has been observed both within and between studies. Previous research in our lab has shown~     that genetic variations affecting caffeine metabolism modify the association between~     caffeine and heart disease. We hypothesize that the inconsistencies among studies relating~     caffeine and athletic performance may be due to genetic differences in caffeine metabolism~     or response. Male athletes will take part in an intervention of caffeine versus placebo,~     using a randomized double-blinded placebo-controlled design, which will test various~     exercise protocols (power, strength, anaerobic capacity, endurance) that are associated with~     performance across multiple sports. We will conduct a genome-wide association study, which~     is an approach that involves scanning for markers across the genomes of our study~     participants together, not individuals, to find genetic variations associated with a~     particular trait such as VO2 max, lactate clearance efficiency, muscle fiber type and~     changes in exercise performance following caffeine. We will also examine known genetic~     variations that are associated with caffeine metabolism and response, to determine if these~     genes also affect response to exercise after ingesting caffeine. Subjects will be paid $50.~   "
72394|NCT02109770|"~     The purpose of this study is to collect blood from families with a child who has been~     diagnosed with a chromosomal disorder including microdeletions in order to further develop a~     non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.~   "
72395|NCT02109757|"~     The specific aim of this research is to evaluate the performance, effectiveness, and~     long-term training benefits of a formal hearing protection fit testing program. This study~     may provide preliminary evidence on the benefits of direct education/training combined with~     a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air~     Force (USAF) employees. Currently, Public Health provides informal, subjective training to~     employees; this practice may be altered by the results of this study.~   "
72396|NCT02109744|"~     To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in~     the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and~     in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.~   "
72397|NCT02109731|"~     The purpose of this study is to determine the effectiveness and feasibility of upper airway~     muscle physical therapy utilizing negative airway pressure (NAP) breathing training in~     patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea~     index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of~     Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles~     will result in muscle conditioning. Interestingly, other studies have indicated that upper~     airway muscle training may be useful in treating OSAS, but these studies used techniques~     that were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical~     stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}~   "
72398|NCT02109718|"~     The Effectiveness of open dressing with petrolatum jelly in minor burns has not been clearly~     established. This study determined if the use of open dressings with petrolatum jelly as~     effective as standard gauze dressing with silver sulfadiazine in treating minor burns in~     terms of time-to-re-epithelialization, incidence of wound infection,incidence of adverse~     reactions, and patient acceptance.~      Non-extensive superficial partial thickness burns constitute a major proportion of burn~     injuries. Conventional treatment involves regular changing of absorptive dressings including~     the application of a topical antimicrobial, commonly silver sulfadiazine. A systematic~     review has found insufficient evidence to support or refute such antimicrobial prophylaxis.~     Another review compared silver sulfadiazine dressings with other occlusive and~     non-antimicrobial dressings and found insufficient evidence to guide practice. Other~     research has suggested that dressings with petrolatum gel are as effective as silver~     sulfadiazine. This trial sought to compare the effectiveness of conventional silver~     sulfadiazine dressings with treatment with petrolatum gel alone.~   "
72399|NCT02109705|"~     With this study the investigators would like to analyze the the role of periodontal disease~     and especially the role of Porphyromonas gingivalis in initiation and progression of~     Alzheimer`s Disease.~   "
72400|NCT02109692|"~     Duchenne muscular dystrophy (DMD) , caused by mutations in the DMD gene, is the most common~     and most severe progressive dystrophy of the child. Although the development is rapidly~     progressive , there is variability in the severity of the disease between DMD patients that~     do not correlate with the type of mutations in the DMD gene. There are no easily measurable~     biomarkers for monitoring the DMD or moderate form of the disease, Becker muscular dystrophy~     (BMD ) . MicroRNAs (miRNAs) are involved in most cellular processes , and their expression~     pattern is a signature of the state of a cell . They represent a potential class of~     diagnostic and prognostic biomarkers. Some are specific for the skeletal myogenesis , and~     changes in their pattern of expression are associated with muscle diseases including~     muscular dystrophy. The levels of muscle- specific miRNAs are indeed greatly increased in~     the serum of DMD and BMD compared to control patients .~      The main objective of this is to validate the use of serum muscle-derived microRNAs as~     biomarkers of DMD patients (compared with healthy subjects). Secondary objectives are i) to~     investigate the relationship between circulating levels of these miRNAs and the severity of~     the dystrophinopathy (DMD vs BMD) and also the progression of the disease (longitudinal~     study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with~     other patients with muscular dystrophy), iii) to test candidate miRNAs recently identified~     but not yet analyzed in the serum of patients.~      Clinical data and samples will be recorded at each regular consultation. miRNA levels will~     be quantified using Real Time Quantitative RT-PCR.~   "
72401|NCT02109679|"~     To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral~     administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI~     187004 and metformin given alone.~   "
72402|NCT02109666|"~     The purpose of this study is to estimate the retention rate of Abatacept over 24 months in~     routine clinical practice in every participating country depending on the treatment line.~   "
72435|NCT02109237|"~     This study is to determine whether sleep disorders contribute to impaired quality of life~     and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive~     positive airways pressure ventilation can improve sleep, quality of life and mobility in~     this patient group.~   "
72404|NCT02109640|"~     Two key requirements for discharge from hospital after major abdominal surgery are adequate~     oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed~     discharge after abdominal surgery due to delayed return of gut function, manifesting as~     nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are~     the mainstay of postoperative analgesic regimens after abdominal surgery and are highly~     effective in achieving adequate pain control. However, opioids cause impaired gut function~     by reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers~     such as Alvimopan counteract these effects and can accelerate postoperative gut recovery but~     are expensive and cause cardiac complications; alternative painkillers such as non-steroidal~     anti-inflammatories are less effective than opioids and have been linked with increased risk~     of anastomotic leaks.~      Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride)~     and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product~     confines the naloxone action to the gut to reduce the unwanted side-effects on gut function.~     Targinact has been shown in patients with chronic severe pain to provide comparable~     analgesia to other opioid analgesics whilst reducing the unwanted side-effect of~     constipation.~      The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia~     after colonic resection with reduced postoperative gastrointestinal dysfunction. The~     surgical procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a~     consistently reproducible intervention with a postoperative gut dysfunction rate of up to~     40% (prospective data from the Edinburgh Colorectal Unit). The main outcome of the study~     will be return of normal gut function at the time of planned discharge (Day 3).~   "
72405|NCT02109627|"~     The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a~     standard treatment for AML, is safe to give to patients and to determine the best dose to~     give. The study doctors want to see what effects, good and/or bad, the study drug has on~     subjects and their AML. The study will look at what side effects subjects may have and how~     subjects feel after receiving the study drug.~   "
72406|NCT02109614|"~     Aortic valve disease is the most common form of heart valve disease and is a major burden to~     society. Aortic valve disease is also expected to become more prevalent with the aging of~     the Canadian population. Currently, over 1 million individuals in North America have aortic~     stenosis, which is a narrowing of the aortic valve, and leads to symptoms of heart failure~     and sometimes death. Valve replacement with its potential costs and complications remains~     the only avenue for treatment, once symptoms develop. Despite the major importance of this~     disease, there are currently no medical treatments to prevent the development of aortic~     stenosis.The lack of preventative treatments stems in large part to a poor understanding of~     the causes of this disease.~      Using cutting-edge genetic technologies, the investigators have recently identified that~     individuals with a genetic predisposition to elevations in a type of cholesterol not~     normally screened, called lipoprotein(a), have a much higher risk of developing aortic valve~     disease. The investigators have also shown that lipoprotein(a) causes hardening of the~     valve, a very early sign of valve narrowing. The investigators plan to evaluate in a~     randomized controlled trial whether lowering this unusual form of cholesterol at an early~     stage of this disease could slow or stop the development of aortic valve narrowing~      The investigators are currently proposing a pilot project to evaluate the feasibility of~     this type of study. If successful, our proposed treatment would be notable in two ways.~     First, it would represent the first medical treatment to prevent valve disease, which could~     lead to major reductions in the societal burden of this important disease. And second, it~     would herald a major success for genomic medicine as it would represent one of the first~     treatments borne from recent genetic studies. In these ways, our proposal could~     significantly impact the health of many Canadians while also highlighting the innovative~     research performed in Canada.~      Recruitment (n=238) for this project will be from the echocardiography laboratories of~     McGill University affiliated hospitals. Individuals with aortic sclerosis or mild aortic~     stenosis (aortic valve area [AVA] >1.5 cm2, mean gradient [MG] < 25 mmHG) and high Lp(a)~     will be eligible for inclusion into this proposed study.~   "
72407|NCT02109601|"~     RESEARCH QUESTION:~      Are hospitalized patients able to use a tablet computer (iPad) to take brief surveys, access~     their patient portal (MyChart), and watch informational videos about their condition?~   "
72408|NCT02109588|"~     The main aim of this study was to examine the effect of a supervised physical exercise~     program on the prevention of childhood obesity and its impact on the motor development of~     the offspring.~   "
72409|NCT02109575|"~     The primary goal of this Multicenter Study is to develop and to evaluate a method for~     measuring donor-specific cell free DNA in blood samples from transplant recipients as~     markers of rejection. Blood samples obtained periodically from heart transplant recipients~     are assessed for cell free DNA relative to clinical data in order to determine whether~     changes in the level of cell free DNA indicate rejection.~      This research study proposes testing a blood sample obtained from the heart transplant~     recipient. The research seeks to establish whether this blood test will show when the~     patient is beginning to or already rejecting the transplanted heart.~      BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the~     heart is necessary, so that appropriate treatment can be started to halt the rejection.~     Heart catheterization with biopsy is the usual method used for assessing whether a patient~     may be rejecting the heart. There are also a number of other methods that transplant~     physicians will use to look for signs of rejection including other blood tests,~     echocardiograms, obtaining pressure readings during heart catheterization, and micro-array~     testing of blood obtained during biopsy. These technologies are limited in ability to~     consistently and accurately identify the presence of rejection.~      The usual method of checking for rejection involves obtaining a sample of the heart tissue~     (heart biopsy); biopsy can only be accomplished through heart catheterization which is an~     invasive procedure that has risks associated with disturbing the heart such as puncturing~     the heart or causing the heart rate to change or damaging tissue in the heart. Overtime,~     repeating this invasive procedure can diminish the ease of the procedure because the veins~     can become scarred and more difficult to access. For these reasons, researchers believe that~     it would be good to have a blood test that gives information about the possibility of~     rejection so that it may not be necessary to do as many heart biopsies. Also, a blood test~     may be able to provide information about the heart or about rejection that is currently not~     available at all.~   "
72410|NCT02109562|"~     The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with~     placebo in the treatment of patients with schizophrenia.~   "
72411|NCT02109549|"~     There are preliminary data suggesting that patients suffering from non-insulin-dependent~     diabetes mellitus, treated with metformin, have improved local tumor control. A reduction in~     the tumor's hypoxia may be responsible for this phenomenon.~      Therefore, the aim of this study is to test the hypothesis in three cohorts of patients~     suffering from advanced stage non-small cell lung cancer and all undergoing concurrent~     radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2.~     Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The~     remaining patients serving as controls. Furthermore, tumor and treatment-related parameters~     will be correlated with overall survival and morbidity.~   "
72412|NCT02109536|"~     The purpose of this study is threefold. First, the ability of experienced colonoscopists to~     recognize the type of loop formed will be assessed and whether the use of the MEI improves~     this accuracy. Second, to determine which maneuvers are used for loop reduction and whether~     certain loops have set ways to reduce them. The third component will assess whether the~     colonoscopist thought that the imager helped or not.~   "
72413|NCT02109523|"~     Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but~     non-adherence to post-CABG guideline medications is a common and serious clinical concern in~     this age group. A recent systematic review found that higher medication adherence~     significantly improved primary and secondary prevention of coronary artery disease outcomes~     in all the included studies. Another systematic review assessed studies published from~     1999-2009 about motivational interviews, such as implementation intention, in relation to~     cardiovascular health. They found that motivational interview was an effective means of~     changing behavior, while offering promise in improving cardiovascular health status. The~     study is aimed to investigate effectiveness of long term volitional intervention in proving~     medication adherence in the CABG patient.~   "
72414|NCT02109510|"~     Investigators compared the patients' subjective postoperative symptoms and complications~     between the double lumen endotracheal intubated patients under general anesthesia and~     non-intubated patients under sedation and local anesthesia including~        1. postoperative Visual scale of pain~        2. postoperative sore throat/voice change~        3. postoperative nausea/vomiting~        4. intraoperative Arterial blood gas analysis~        5. cost for anesthesia~        6. morbidity~   "
72415|NCT02109497|"~     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose~     of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy~     volunteers.~   "
72416|NCT02109484|"~     This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The~     study will examine the safety and immunogenicity of this vaccine first in healthy South~     African toddlers. If the safety profile is deemed appropriate, the study will continue to~     explore the safety and immunogenicity of the vaccine in healthy South African infants.~      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and~     well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is~     that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will~     induce an immune response in at least 80% of participants in at least one of the study~     groups.~   "
72417|NCT02109471|"~     A prospective observational study on corneal opacities (scar and stromal dystrophy) in~     adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT prototype will be~     used to perform 3-D corneal scans. These scans will be used to assess opacity depth and~     measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and~     epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when~     they become available. A comprehensive eye examination, Placido-ring corneal topography,~     ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison~   "
72418|NCT02109458|"~     The goal of this study is to evaluate the feasibility and safety of navigation guided~     virtual transthoracic needle biopsy combined with navigational bronchoscopy for the~     diagnosis of peripheral pulmonary nodules (PPN).~   "
72419|NCT02109445|"~     This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and~     the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel~     followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of~     overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously~     treated with anticancer therapies.~   "
72420|NCT02109432|"~     The purpose of this investigation is to evaluate participant use of a dedicated office pedal~     desk with and without behavioral support.~   "
72421|NCT02109419|"~     While standard pencil-and-paper test have continued to be useful for the monitoring of~     cognition, mood, and life space (LS) in the elderly they do have considerable limitations.~     Use of these pencil-and-paper tests requires that individuals come to the clinic for~     assessments, which results in significant clinical costs and practical limitations in the~     conducting of assessments in large numbers of individuals, and provides a time consuming and~     non-automated means of quantifying and recording changes in brain function. It is~     increasingly recognized that there is a need to develop valid and reliable computer based~     assessments to allow for the remote assessment of cognition, mood, and LS. Development of~     computerized based assessments will significantly increase the scale, scope, and speed with~     which cognition, mood, and LS can be measured in the elderly.~      Helping Hands Technology LLC (HHT) has developed a number of web based assessments of~     cognition, mood, and LS. These new computerized assessments will be developed using new~     technology, and are based on the general principles found in existing pencil-and-paper based~     assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of~     reporting the results of the computerized assessments in an easy to use narrative format.~     This study will focus on quantifying the feasibility and validity of using HHT computerized~     assessments.~   "
72422|NCT02109406|"~     This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days),~     three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and~     safety of two dose levels of a dual pharmacology molecule with the combined properties of a~     long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115)~     delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
72423|NCT02109393|"~     The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary~     rehabilitation treatment, previously conceived for Parkinson's disease, is effective for~     patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat)~     can provide further benefits.~   "
72424|NCT02109380|"~     In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber~     characteristics and insulin sensitivity will be determined.~   "
72425|NCT02109367|"~     This study involves women who are scheduled to have surgery for a pelvic or ovarian mass~     that is suspicious for epithelial ovarian cancer (EOC). The physician will perform an~     additional procedure on all patients known as 'culdocentesis'. This will be done just prior~     to their scheduled surgery while the patient is under general anesthesia. Culdocentesis is a~     procedure typically used to check for abnormal fluid in the space just behind the vagina.~     This pocket of space is called the cul-de-sac. The purpose of this study is to determine if~     levels of tumor markers, CA-125 and HE4, are measurable from the cul-de-sac fluid. If these~     tumor markers are measurable from the cul-de-sac fluid and correlate with the patient's~     diagnosis, this procedure may be used in the future as an additional diagnostic tool for~     EOC. In addition, a single urine sample will be collected from each patient to measure the~     ratio of good to bad estrogen. Investigators hypothesize this ratio will also correlate~     with EOC diagnosis. Study results could lead to development of an alternative, minimally~     invasive and low risk diagnostic tool in patients with an ovarian mass suspicious for~     malignancy.~   "
72436|NCT02109224|"~     This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell~     non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with~     human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether it is~     safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.~   "
72426|NCT02109354|"~     The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines~     in combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that~     causes AIDS. Tetanus is an infection that causes muscular spasms. Hepatitis B is a virus~     that can cause liver failure.~      About 100 people will take part in this study at multiple sites. The US National Institutes~     of Health (NIH) is paying for the study.~      We are doing this study to answer several questions.~        -  Are the HIV study vaccines safe to give to people?~        -  Are people able to take the HIV study vaccines without becoming too uncomfortable?~        -  How do people's immune systems respond to the HIV study vaccines? (Your immune system~          protects you from disease.)~        -  Can people's immune responses to a tetanus or hepatitis B vaccines help us understand~          how their immune systems might respond to the HIV study vaccines?~        -  Is there a common immune response to licensed vaccines like the tetanus and hepatitis B~          vaccines?~   "
72427|NCT02109341|"~     At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic~     pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or~     Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) [Nab-FOLFIRI and Nab-FOLFOX].~      Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both~     schedules will be evaluated in successive phase II part.~   "
72428|NCT02109328|"~     Background:~      Progress in developing new effective therapies in advanced and relapsing urothelial cancer~     has been stagnant in the last few decades and a paradigm shift is desperately needed. Aurora~     kinase-A overexpression has been previously described in bladder cancer and spindle~     checkpoint dysregulation is a common feature of human urothelial carcinoma (UC).~      Alisertib (Millennium Inc.) is an orally available, selective small molecule inhibitor of~     Aurora A kinase. Single agent and combination treatment of MLN8237 with either paclitaxel~     (TXL) or gemcitabine synergistically reduced UC cell viability compared with either drug~     alone. Hence, sequential application of MLN8237 and TXL warrants clinical investigation.~     Phase 1 trials of both single agent and the combination with TXL defined the recommended~     doses for phase 2 trials.~      Methods:~      A multistep approach will be adopted for this Phase 2 trial. A single-group run-in phase~     will be conducted first with Alisertib 50 mg orally BID for 7 days, followed by 14d rest~     until disease progression. In case of activity, a confirmatory randomized (1:1) trial of~     weekly TXL plus either Alisertib or Placebo will follow, incorporating efficacy and futility~     boundaries for early stopping. In a single-blind design, TXL will be given on days 1,8,15~     q4wks at the dose of 60 mg/m2 with alisertib and 80 mg/m2 with placebo. Alisertib dose will~     be 40 mg BID days 1-3, 8-10 and 15-17, q4wks.~      In the single-arm phase, primary endpoint (EP) will be Response Evaluation Criteria in Solid~     Tumors (RECIST) 1.1 response-rate. 20 pts will be accrued, ≥3 responses will be required~     (10% type I and 20% type II error constraints). An accrual of 110 pts is foreseen in the~     randomized phase. Primary EP: progression-free survival (PFS), assuming an improvement in~     PFS from a median of 2.5 months (H0) to a median of 4.5 months (H1) (44% hazard rate~     reduction, 10% drop out rate).~      Eligibility will include diagnosis of metastatic UC and failure of 1-2 CT regimens~     (single-arm) or 1 prior CT only (randomized phase). A relapse within 6 months of a~     peri-operative CT will be counted as 1 line. Computed tomography and PET will be done every~     2 cycles (2 months). Additional pharmacodynamic and translational analyses are planned on~     pre- post- blood and tissue samples.~   "
72429|NCT02109315|"~     To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients~     with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes~     of endothelial function~   "
72430|NCT02109302|"~     The main objective of our study is to identify the first genetic etiology of primary~     Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism~     conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some~     patients. To this end, we plan to establish a collection of biological samples and a~     database of patients with this extreme syndrome, which we will analyze by Genome Wide~     analysis. This will lead to improvements in the biological understanding, the knowledge of~     physicians of the disease, and should improve the patients' quality of life. Not all PE~     cases have the same physiopathology and treatment efficiency, which depend on the specific~     mechanism involved in the clinical context. Our work will make it possible to develop new~     therapeutic approaches suitable for a large proportion of individuals presenting PE. This~     integrative approach combining researchers, patients and ethics committees will facilitate~     profound reflection, promoting the creation of suitable structures capable of receiving~     patients for appropriate consultations. This unique study of PE should also favor industrial~     partnerships.~   "
72431|NCT02109289|"~     The primary goal of this preliminary project is to study the effect of etanercept, a~     medicine approved by Health Canada for the treatment of rheumatoid arthritis, on the~     inflammation of certain blood vessels. In particular, the inflammation of the aorta and the~     carotid arteries will be studied.~      This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor)~     alpha) could have an effect on blood vessel inflammation. As well, the information from this~     study will be used to determine the number of patients to recruit in a future study.~      This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis~     at one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal~     Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood~     vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.~      To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission~     Tomography).~   "
72432|NCT02109276|"~     The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need~     cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric~     lenses. If both eyes of a patient need surgery, we will implant the same type of lens in~     each eye in order to prevent imbalanced vision. We will measure their contrast sensitivity~     and higher order aberrations before surgery and 3 months after surgery. We will compare the~     change in these values between the two groups.~   "
72433|NCT02109263|"~     The aim of this study is to compare the impact of two non-medicinal strategies: the~     breast-feeding and saccharose to measure effects in cerebral cortex during pain using near~     infrared spectroscopy (NIRS)~   "
72434|NCT02109250|"~     In this registry it is planned to include all Belgian patients diagnosed with aggressive and~     symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who~     have been prescribed Caprelsa® (vandetanib).~      The characteristics of patients receiving Caprelsa® (vandetanib) will be described.~     Therefore real life data regarding demographic characteristics, evolution of the disease,~     RET mutation status, the treatment before, during and after vandetanib, dose and duration of~     treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will~     be included.~   "
72438|NCT02109198|"~     The purpose of this study is to determine the feasibility of combining PoNS therapy with~     standard vestibular and balance therapy with the proposed double-blind design; evaluate~     preliminary indications of efficacy. This study is also evaluating recruitment rate,~     completion rate, device usability, and outcome measures feasibility.~        -  Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be~          recruited over the 36 week pilot recruitment phase.~        -  Completion and compliance: 90% of subjects will complete the study, 90% of sessions~          within each subject will be completed, and for completing subjects, 100% of measures~          will be completed.~        -  Useability: all therapists and subjects must rate useability as good or better.~        -  Success of blind: subject accuracy at guessing group membership must be at or near 50%.~   "
72439|NCT02109185|"~     The study will compare the safety and efficacy of a generic mometasone nasal spray to the~     reference listed drugs in the treatment of seasonal allergic rhinitis. Additionally both the~     test and the reference formulations will be tested for superiority against a placebo nasal~     spray.~   "
72440|NCT02109172|"~     This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo~     when administered using a jet nebulizer for 7 days in a cross-over design to patients with~     moderate to severe chronic obstructive pulmonary disease.~   "
72441|NCT02109159|"~     The investigators will conduct a two-arm, randomized controlled trial of the effect of~     emotional content in online videos on the extent to which the video is disseminated~     (forwarded). Dissemination can be assessed in terms of the number of views which can~     increase as a result from sharing and forwarding of the video.~      In this study, an experiment video and a control video, both of which are approximately 2.5~     minutes long, will be uploaded on YouTube, the most visited video sharing website. The~     videos concern the WOMAN trial, a large RCT of tranexamic acid in postpartum hemorrhage. The~     experimental group will receive a video with strongly emotional content (an interview with a~     postpartum hemorrhage survivor and her husband). The control group will receive a short~     video in which a researcher conveys the same information (but without the first hand~     experience of the survivor and her husband). Otherwise, the two videos are identical.~      Participants, selected from clinicians and researchers in obstetrics and gynecology, will be~     randomly allocated to two groups. An e-mail with a link to either of the videos will be sent~     to the participants. In the e-mail, they will be asked to watch the video and forward the~     link to their colleagues if they find it helpful.~      The primary outcome is video forwarding. The secondary outcome is the number of access to~     the video that each participant generated.~      Data will be collected for 14 days after the e-mails are sent to the participants. The~     relative risk (RR) of forwarding the videos will be calculated as effect measure and~     compared using chi-square test. The distribution of the numbers of access to the video that~     each participant generated will be compared using Wilcoxon signed-rank test.~      The hypothesis is that an online video with emotional content has higher chance of being~     forwarded to other people and therefore, gets higher number of views than an less emotional~     online video.~   "
72442|NCT02109146|"~     1. Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver,~          representing the third leading cause of cancer-related death worldwide.~        2. Its overall dismal prognosis is a result of high incidence rates of metastasis and~          postoperative recurrence, in particular the intrahepatic recurrence.~        3. TACE is the most widely used primary treatment for unresectable HCC. It was also used~          as the optional treatment of relapsed disease. However, the efficacy of TACE used as~          adjuvant therapy following hepatectomy remains controversial.~   "
72443|NCT02109133|"~     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical~     prostatectomy which is performed in a steep trendelenburg position at prolonged times of~     pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical~     visibility through deep neuromuscular blockade on intraocular pressure in patients~     undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.~   "
72444|NCT02109120|"~     1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9~          concentration cross CEA will be identified.~        2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level~          will increase in the early stage after CEA.~   "
72445|NCT02109107|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.~   "
72446|NCT02109094|"~     The investigators seek to examine the metabolic changes that occur amongst obese and lean~     pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus~     (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant~     age matched controls. Given the adaptive tendency of the maternal body to use alternative~     energy sources such as ketones and free fatty acids rather than glucose and to shunt glucose~     and amino acids to the fetus, the investigators hypothesize that the amino acid and fatty~     acid profile will be reflective of this adaptive change and that maternal insulin resistance~     will result in alterations in this pattern in both the plasma and CSF. Furthermore, the~     investigators also hypothesize that maternal degrees of insulin resistance will also be~     reflected in CSF hormonal changes.~   "
72447|NCT02109081|"~     Postoperative delirium is commonly observed in elderly patients in the postanesthesia care~     unit (PACU) and during the first 2-3 days following surgical procedures. This is an~     important clinical problem in the geriatric surgical patient; morbidity and mortality rates~     are significantly higher in patients who develop delirium. At the present time, the etiology~     of delirium has not been precisely defined. However, studies suggest that inflammation~     related to the surgical stress response is an important contributing factor in inducing~     neuroinflammation and subsequent cognitive dysfunction and delirium. Therefore it is~     possible that agents which attenuate perioperative inflammation may reduce the risk of the~     development of delirium following surgery. Dexamethasone is a potent corticosteroid that is~     used by anesthesiologists primarily as an antiemetic agent. Small doses of dexamethasone~     have also been demonstrated to significantly reduce the release of inflammatory markers~     after surgery. The anti-inflammatory effects of corticosteroids have the potential to~     beneficially impact neuroinflammation and the risk of developing postoperative delirium. The~     aim of this randomized, controlled, double-blinded investigation is to determine if~     dexamethasone, administered at induction of anesthesia, can decrease the incidence of~     delirium at the time of discharge from the PACU and during the first 2 days following~     surgery.~   "
72448|NCT02109068|"~     The specific aims of this study are to determine the efficacy and cost-effectiveness of a~     weight loss program compared with usual care (control) treatment on 6-month changes in body~     weight, body fat, and serum hormones in breast cancer survivors.~   "
72754|NCT02105038|"~     The aims of the study are to better understand how upper extremity injury and immobilization~     influences a patient's steering ability. Patients with acute distal radius fractures treated~     with surgery will be recruited for study in a driving simulator. The results will hopefully~     assist physicians to better counsel patients with upper extremity injuries on when it is~     safe to return to driving.~   "
72449|NCT02109055|"~     The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat~     these diseases is coronary artery bypass grafting, one of the most common surgical~     procedures in the world. The incidence of post-operative complications contributes to~     functional decline of the patient, reduced quality of life and post-discharge mortality.~     Also, cardiac surgery leads to changes in lung capacity and respiratory muscle strength,~     causing a decrease in the function lung. Physical therapy proves to be an effective tool to~     combat changes resulting from cardiac surgery, demonstrating beneficial results in the~     pulmonary function, functional capacity, and peripheral and respiratory muscle strength. The~     Pilates method has been studied as a therapeutic way to healthy subjects and various kinds~     of diseases, but there are no studies in the literature evaluating the effect method in~     patients after coronary artery bypass surgery.~      The aim of this study is to investigate the effect of Pilates on functional capacity , flows~     and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass~     grafting.~      Randomized clinical trial in which patients will be eligible after elective coronary artery~     bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n =~     15) and Pilates method associated with conventional physiotherapy group (n = 15). The~     outcomes will be assessed by blinded evaluator and data randomization will be performed~     through by electronic randomization.The interventions will take place during the length of~     stay in the hospital, totalizing a maximum of six days of intervention.~      It is expected that the application of the Pilates method exercise method associated with~     conventional physiotherapy in patients in postoperative coronary artery bypass grafting~     improves functional capacity, flows and lung volumes and respiratory and peripheral muscle~     strength.~   "
72450|NCT02109042|"~     The purpose(s) of this study is to measure how much of the study drug gets into the blood~     stream and how long it takes the body to get rid of it when given in multiple doses,~     subcutaneously (SQ) (by inserting a needle just under the surface of the skin in the lower~     abdominal area), to post-menopausal female participants. Information about any side effects~     that may occur will also be collected.~      This study will also be looking for special markers called biomarkers that can be used to~     study osteoporosis and/or the effects of the study drug.~      There will be 2 parts to this study. The first part will last approximately 6 weeks and the~     second part will last approximately 7 weeks.~   "
72451|NCT02109029|"~     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.~     This study is designed to understand how the body handles the investigational drug, and to~     measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves~     intravenous (IV) infusion of the investigational drug and a procedure to measure~     concentrations in the fat tissue. Both parts of the study will be conducted in participants~     with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to~     complete.~   "
72452|NCT02109016|"~     The purpose of this study is to determine whether lucitanib is safe and effective in the~     treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor~     (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor~     (PDGF) related genetic alterations.~   "
72453|NCT02109003|"~     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff~     underinflation and overinflation frequently occur in critically ill patients, resulting in~     increased risk for microaspiration and tracheal ischemic lesions.~   "
72454|NCT02108990|"~     Recent research has identified heightened sensitivity to social rejection as a core feature~     of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious~     behaviors characteristic of the disorder.~      Therefore targeting therapy towards the reduction of rejection sensitivity may improve the~     low rates of effectiveness of current pharmacological and behavioral therapies. Therefore,~     this proposal tests a theoretically-based pharmacological approach that specifically targets~     the heightened sensitivity to rejection experienced by BPD patients.~      In prior research with normal controls, it was shown that chronic treatment with the~     physical pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social~     rejection (using fMRI) as well as self-reported feelings of rejection in a daily diary~     study.~      It is the aim of this research project to determine if the over-the-counter analgesic,~     acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD~     patients. The goal of this proposal is to use an open-label design to determine if~     acetaminophen improves symptoms in BPD patients.~   "
72455|NCT02108977|"~     Genetic counseling has benefits for individuals and their family members in their health~     care decision-making. Provision of genetic counseling has been deemed standard of care by~     several medical organizations and incorporated into clinical guidelines, such as those of~     the US Preventive Services Task Force. To better comply with these guidelines, Genomic~     Medicine Service (GMS) recently established at the Salt Lake City, Utah VA medical center to~     provide genomic services and counseling as a part of VA Patient Care Services. For Veterans~     for whom in-person genetic counseling in not feasible, GMS conducts counseling either via~     telephone or videoconferencing. Although both of these methods can be effective for~     delivering genetic counseling, each has its relative advantages and disadvantages. The~     specific aim of this study is to gain a better understanding of the advantages and~     disadvantages of these two modalities. This information will be useful not only for genetic~     counseling but also other interventions that use telephone or videoconferencing to access~     patients.~   "
72456|NCT02108964|"~     To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l~     part) of EGF816 and to investigate the anti-tumor activity of EGF816 (Phase II part).~   "
72457|NCT02108951|"~     The purpose of this Australian study is to assess the efficacy and safety of nilotinib 300mg~     twice daily in patients with chronic myeloid leukemia chronic phase who are intolerant but~     responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been~     previously treated with imatinib or dasatinib for at least 3 months and are experiencing~     non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st~     line treatment of CML without current MR4.5.~   "
72458|NCT02108938|"~     The primary aims for this research are to 1) characterize brain changes in patients with CD~     compared to age and gender-matched controls and 2) relate these brain changes to measures of~     disease activity and pain severity.~   "
72459|NCT02108925|"~     The project will test the hypothesis that lung ventilation during exercise is unaffected by~     oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea,~     heart rate and blood pressure will be studied.~   "
72460|NCT02108912|"~     This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic~     benefits for persons post stroke that learn to walk utilizing early treadmill training~     post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based~     gait training during the same time period. Participants (n=30) will be adults who have~     completed acute rehabilitation following a stroke. Random assignment will be to either the~     ESTT or traditional gait training protocol during the outpatient rehabilitation phase.~        1. Group A: Traditional outpatient therapy (n = 15)~        2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)~   "
72461|NCT02108899|"~     When people are tested on a previously learned material, they will later remember it better~     even when compared to a condition where they can re-study it. This phenomenon is called~     retrieval practice and is supported by an extensive research literature mostly carried out~     in normal students. This paradigm begins to be used in cognitive remediation programs in~     patients suffering from memory difficulties.~      The objective of this study is to investigate whether retrieval practice is spared in~     patients with schizophrenia.~      If effective, this method could be used in cognitive remediation programs.~      Since episodic memory difficulties are supposed to be secondary to deficits in the~     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that~     retrieval practice is spared in schizophrenia.~   "
72462|NCT02108886|"~     Preterm birth is a major public health problem, and actual treatments are not very~     efficient. The purpose of this study is to test the efficiency of a combined use of~     Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine~     contractions more efficiently than with the use of Nifedipine only.~   "
72463|NCT02108873|"~     Our objectives were to estimate the prevalence of nonattendance at outpatient offices, to~     identify the characteristics of appointments for which nonattendance was more likely to~     occur, and to generate a predictive model that could be applied to each appointment to~     estimate the probability of nonattendance.~   "
72464|NCT02108860|"~     Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of~     abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing~     non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be~     randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous~     injection once a week. Participants will continue on study treatment for a minimum of 12~     months unless they experience a disease relapse or disease flare.~      Participants who experience a non-severe disease relapse, non-severe disease worsening, or~     who have not achieved remission by month 6 will have the option of entering an open-label~     trial period whereby they would receive open-label abatacept.~   "
72465|NCT02108847|"~     The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks~     performed before surgery help to reduce pain after elective total hip replacements.~   "
72466|NCT02108834|"~     For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine~     whether it offers real benefits in terms of patient outcome from major surgery, compared~     with general anesthesia. Although it is clear that regional analgesia in association with~     general anesthesia substantially reduces postoperative pain, the benefits in terms of~     overall perioperative outcome are controversial. The aim of this study is to evaluate the~     effect on short and long-term postoperative outcomes of adding regional analgesia to general~     anaesthesia in thoridetomic patients.~   "
72467|NCT02108821|"~     A disturbance in the diversity of gut bacterial composition could be linked to several~     immune mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified~     into Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from~     abnormal immune reaction to resident gut bacteria.The process of fecal microbiota~     transplantation (FMT) where fecal bacteria from a healthy individual is transferred into a~     recipient, has recently received attention as an alternative therapy for individuals~     affected with these life-altering diseases. In this study, the investigators will perform~     fecal transplantation on the subjects meeting inclusion criteria, to determine the efficacy~     and safety of this therapy in subjects with IBD (CD and UC) who are not responding to first~     line therapy, and are in a flare.~   "
72468|NCT02108808|"~     Fractional flow reserve (FFR) is an established invasive method for assessing the~     physiological significance of coronary artery stenosis. Adenosine, an important endogenous~     regulator of coronary blood flow during both stress and ischemia, is widely used to achieve~     conditions of stable hyperemia required for measurement of FFR.~      Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post~     percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential~     coronary blood flow velocity response during increasing doses of adenosine compared to~     placebo or prasugrel treated subjects, respectively. It has also been demonstrated that~     patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has~     been hypothesized that the degree of hyperemia obtained with adenosine infusion may be~     greater in patients on ticagrelor than that obtained in patients taking clopidogrel or~     prasugrel. If this proves to be true, it would lead to a lower FFR value with possible~     important clinical implications in ticagrelor receiving patients in need for FFR~     measurement.~      This is a prospective, single center, randomized study of parallel design. Consecutive~     ticagrelor naive patients who are referred for coronary angiography and have an~     angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual~     assessment) in at least one major epicardial coronary artery amenable to PCI are candidates~     for this study. Patients after informed consent will be randomized (hour 0) to receive~     immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute~     period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading~     dose (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.~   "
72469|NCT02108795|"~     The aim of the present study is to assess the effect of postoperative remifentanil infusion~     on the incidence of emergence agitation in preschool-aged children undergoing strabismus~     surgery with sevoflurane anaesthesia.~   "
72470|NCT02108782|"~     This phase II trial studies how well dovitinib lactate works in treating patients with~     pancreatic neuroendocrine tumors. Dovitinib lactate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
72471|NCT02108769|"~     Our aim is to analyze two ancient Tamil practices (chanting and breathing exercise) if they~     are capable of stimulating saliva containing agents that can be beneficial to the nervous~     system. Our study subjects will perform Tamil chanting and Tamil breathing exercise. Saliva~     will be collected before, during and after the exercises. We will quantify the specific~     proteins in these salivary samples. The results will benefit further studies in various~     patient populations.~   "
72472|NCT02108756|"~     The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium~     to treat upper gastrointestinal ulcer bleeding.~   "
72473|NCT02108743|"~     The purpose of this study is to determine if dynamic hyperinflation seen in patients with~     idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.~   "
72475|NCT02108717|"~     1. Purpose~           - The investigators aim to evaluate the feasibility of iPhone based remote control~          system as a real-time remote CT reading tool for suspected appendicitis under 3G~          network and the suboptimal illumination.~        2. Methods~             -  A total of 120 abdominal CT examinations; sixty had no findings of appendicitis,~               while the other sixty showed signs of acute appendicitis, were selected. The 16~               raters reviewed these images using an LCD monitor of the PACS workstation and also~               an iPhone which was connected to the PACS workstation via remote control system,~               grading the probability of presence of acute appendicitis on each examination by a~               five Likert scale.~             -  The investigators will compare the diagnostic performance between two devices.~   "
72476|NCT02108704|"~     It has been hypothesized, based on epidemiological observations, that Helicobacter pylori~     (HP) infection may play a role in the pathogenesis of Parkinson's Disease (PD). Previous~     studies have also shown that HP eradication therapy may result in improvements in levodopa~     pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP~     eradication, using a double-blind randomized placebo-controlled trial design in a relatively~     large cohort of patients. Outcomes of interest include motor function, gastrointestinal~     symptoms and health-related quality of life. The investigators hypothesize that HP~     eradication will lead to improvements in motor function. The primary outcome of interest is~     the ON-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary~     outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia~     scores measured by Parkinson's Kinetigraph (PKG), 72 hour Diary, Leeds Dyspepsia~     Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and~     Part IV; and Montreal Cognitive Assessment (MOCA).~   "
72477|NCT02108691|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement~     of body fat. The investigators measured decrement of body fat parameters , including Body~     Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood~     pressure.~   "
72478|NCT02108678|"~     The purpose of this research study is to examine whether a one-day group workshop,~     integrating principles from Acceptance and Commitment Therapy and Migraine Education, will~     result in greater improvements in depressive symptoms and functioning impairment in patients~     with comorbid migraine and depression than a similar one-day group workshop with Migraine~     Education only.~   "
72479|NCT02108665|"~     The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra~     cavitary injection of diluted gadolinium salts with the classic hysterography, which allows~     to realize at once with no irradiating examination, a complete assessment of the female~     infertility.~   "
72480|NCT02108652|"~     This phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment~     in participants with locally advanced or metastatic urothelial bladder cancer. Participants~     will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are~     treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort~     1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants~     who have progressed during or following a prior platinum-based chemotherapy regimen.~     Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of~     atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue~     until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1~     (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue~     until loss of clinical benefit or unmanageable toxicity.~   "
72481|NCT02108639|"~     Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.~   "
72482|NCT02108626|"~     The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current~     smokers under four distinct conditions: after smoking a conventional cigarette, an~     electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and~     after taking a nicotine lozenge. Participants will be asked to attend four morning study~     visits after overnight smoking abstinence. Standardized questionnaires will be used to~     assess changes under each condition, allowing for the investigation of the efficacy of~     e-Cigarettes in reducing craving by replacing the behavioral component of smoking with~     minimal risk of adverse effects.~   "
72483|NCT02108613|"~     Approximately half of men treated for prostate cancer will be offered hormone deprivation~     therapy during their cancer experience. The secondary effects of this treatment can result~     in osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To~     promote healthy lifestyle choices for couples and maintain their intimacy and emotional~     health we propose the Living Well, an innovative program that combines nutrition, physical~     activity, and sexual health initiatives in one integrated service. This project will be~     piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six~     month period both the experimental and control groups will have access to a workbook~     (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health~     counseling. The experimental group will also have access to an exercise and a nutritional~     program and support by volunteers to keep motivated. Assessment will look at quality of~     life, physical factors, and biomarkers associated with secondary disease.~   "
72484|NCT02108600|"~     Randomized open label clinical trial in which 48 renal transplant recipients with~     inflammation in the 6 month allograft biopsy will either continue usual immunosuppression or~     receive monthly Actemra (Tocilizumab) infusions for 6 months in addition to usual~     immunosuppression.~   "
72485|NCT02108587|"~     This clinical trial studies how well optical coherence tomography works in staging patients~     with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer~     based on the size and/or extent (reach) of the original (primary) tumor and whether or not~     cancer has spread in the body. It also helps the doctor plan the appropriate treatment.~     Optical coherence tomography is a procedure that uses infrared light waves to give~     three-dimensional pictures of structures inside tissues and organs. The pictures are made by~     a computer linked to the light source. Optical coherence tomography may be effective in~     staging patients with upper-tract urothelial carcinomas.~   "
72486|NCT02108574|"~     This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis~     (hay fever) in a park setting.~   "
72487|NCT02108561|"~     Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are~     not routinely repeated on surgical specimens (SS). However, preliminary data suggests that~     testing these biomarkers, on SS when compared to CNB samples can lead to different results.~     Our hypothesis is that The aim of this study is to identify a group of women with invasive~     breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas~     of HER2 amplification are not missed. Another aim is to determine whether further HER2~     testing on the SS in select patients would lead to changes in breast cancer treatment~     options.~   "
72488|NCT02108548|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     ascending oral doses of ASP7657 in healthy subjects.~   "
72489|NCT02108535|"~     The evidence is insufficient to determine whether the types of dressings containing silver~     differ as the time/proportion to complete healing of the wound and pain. We will analyze~     cost-effectiveness of these dressings in outpatients, considering the service provided by~     the National Public Health System.~   "
72490|NCT02108522|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life and if the immune system is weakened, like after a~     transplant, they can cause life threatening infections.~      Patients enrolled on this study will have had an infection with one or more of the following~     viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or~     HHV6 (Human Herpes Virus 6).~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     infections of these viruses after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach~     is not practical when a patient already has an infection.~      Investigators have now generated multivirus-specific T cells (VSTs) from the blood of~     healthy donors and created a bank of these cells. Investigators have previously successfully~     used frozen multivirus-specific T cells from healthy donors to treat virus infections after~     bone marrow transplant and now have improved the production method to make it safer and~     target more viruses.~      In this study, investigators want to find out if they can use these banked VSTs to fight~     infections caused by the viruses mentioned above.~   "
72491|NCT02108509|"~     The purpose of this study is to define the prevalence of low bone density~     (osteopenia/osteoporosis) in patients with chronic pancreatitis. Secondary aims include~     investigating the prevalence of hypogonadism (low sex hormones) in patients with chronic~     pancreatitis and determining if hypogonadism and/or use of narcotic pain medications are~     risk factors for low bone density in this patient population.~        1. Hypothesis:~           Patients with chronic pancreatitis are at increased risk of low bone density~          (osteopenia/osteoporosis), and hypogonadism (low sex hormone levels) and narcotic pain~          medication use are independent risk factors for the development of low bone density in~          this patient population.~        2. The outcome measures include:~           i) Prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic~          pancreatitis (as determined by DXA scan and fracture history).~           ii) Prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis~          (as determined by sex hormone levels and clinical history).~           iii) Identification of hypogonadism and/or opioid use as risk factors for low bone~          density in patients with chronic pancreatitis (as determined by univariate and~          multivariate analysis of multiple risk factors).~        3. After obtaining written consent from potential subjects, a questionnaire will be~          performed outlining risk factors for low bone density. Dual X-ray absorptiometry (DXA~          scan) will be performed to evaluate for low bone density and a blood test will be~          performed to evaluate for low sex hormones, low levels of vitamin D, and other risk~          factors for low bone density.~   "
72492|NCT02108483|"~     This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic~     reaction following irradiation of the skin under controlled conditions.~   "
72493|NCT02108470|"~     The aim of this study is to determine whether by incorporating an OHRQoL measure in dental~     practice will improve patient-dentist communication and enhance patient's satisfaction. The~     objective of this study is to evaluate and compare how useful a standardized OHRQoL~     assessment improves patient-dentist communication with regards to number of relevant OHRQoL~     issues addressed and percentage of most frequently items discussed between the intervention~     and control groups, assess the patient's active participation between the intervention and~     control groups and enhances patient's satisfaction between the intervention and control~     groups.~   "
72494|NCT02108457|"~     The purpose of this study is to determine the effect of specific bone marrow maps developed~     with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton~     beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a~     history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment,~     one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take~     place in the Department of Radiation Oncology.~   "
72495|NCT02108444|"~     This study is a retrospective analysis to explore the incidence of hepatitis B virus~     reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of~     chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus~     infection.~   "
72496|NCT02108431|"~     The purpose of the study is to determine, whether the urinary diversion via suprapubic~     cystostomy compared to transurethral catheterization after robot-assisted radical~     prostatectomy superior the postoperative patient comfort and reduce the postoperative~     bacteriuria.~   "
72497|NCT02108418|"~     1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as~          a new capsule formulation and as the original formulation of oral solution, after a~          single oral dose of 400 mg under fed condition in healthy volunteers.~        2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers.~        3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian~          volunteers.~   "
73310|NCT02097797|"~     Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that~     the intestinal flora is involved in the disease and it has been show that patients with~     Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The~     purpose of this study is to determine the effect of the fecal flora transplantation on~     Crohn's disease.~   "
72498|NCT02108405|"~     A total of ninety - five patients (54men and 41women) were included in the study.~     Fifty-eight patients developed septic complication during ICU stay (sepsis group). Forty~     seven patients were critically ill without evidence of infectious organism (SIRS group). At~     admission, Patients data include clinical status; SOFA score; central venous pressure;~     laboratory analysis and arterial blood gas analysis were measured. Routine cultures were~     obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or~     septic shock as long as their stay in ICU. Memory B cells and Heinz bodies were monitored.~   "
72499|NCT02108392|"~     Pseudoxanthoma elasticum (PXE) is a rare multisystem disorder of autosomal recessive~     inheritance (OMIM# 264800) and an estimated prevalence between 1:25.000 and 1:100.000. PXE~     is characterized by calcification and fragmentation of connective tissue rich in elastic~     fibers. Due to its high content of elastic fibers, Bruch Membrane in eyes of patients~     affected by PXE becomes thickened and calcified. The ocular phenotype is characterized by~     angioid streaks and peau d'orange but also choroidal neovascularizations and chorioretinal~     atrophy thereby in part mimicking the phenotype of age-related macular degeneration. The~     disease is due to mutations of the ABCC6-gene coding for a transmembrane protein which is~     mainly expressed in the liver and kidney. It is hypothesized that ABCC6 is involved in the~     excretion of a yet unknown factor from the liver which inhibits systemic calcification. In~     animal models several candidates for this factor have been identified but direct evidence~     for such a factor in patients with PXE is still missing. The primary purpose of this study~     is to further investigate the ocular phenotype of patients with PXE using multimodal imaging~     and functional testing to delineate the impact of Bruch membrane pathology on the eye.~     Furthermore, possible systemic anti-calcification factors, as well as associations with the~     vascular alterations are investigated to gain more insights into the pathogenesis of PXE..~   "
72500|NCT02108379|"~     This study will investigate usability and compliance related to rhinix nasal filters for the~     treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season~     in Denmark.~   "
72501|NCT02108366|"~     Each year, influenza A infection caused great mortality and morbidity, especially among the~     elderly and individuals with chronic illness. Many of these patients are 'late presenters'~     who are admitted to hospital a few days after symptoms onset and have developed~     complications secondary to immunodysregulation. Antiviral treatment with the neuraminidase~     inhibitor is of limited usage for patients who presented to the hospital 48 hours after~     symptom onset. Apart from ventilatory and extracorporeal membrane oxygenation support,~     treatment options for these patients are limited. Recent animal study has demonstrated that~     combinations of an antiviral agent with a COX-II inhibitor can reduce mortality in mice~     infected with influenza virus. The investigators therefore propose to enrol patients with~     severe influenza A infection requiring hospitalization and oxygen support on a randomized~     controlled trial with celecoxib.~   "
72502|NCT02108353|"~     EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of~     EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian~     rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks~     of intervention will be followed by 12 weeks of washing out.~   "
72503|NCT02108340|"~     This study will evaluate the use of microwave radiometry in a population of patients~     diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the~     study is to report the results of microwave radiometry as a diagnostic tool in acute~     appendicitis and compare those results with the commonly used ultrasonography.~   "
72504|NCT02108327|"~     Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee~     Arthroplasty (TKA).~   "
72505|NCT02108314|"~     Breast cancer is the leading female cancer in Singapore, but 3 in 5 women are not going for~     their regular mammography screenings at recommended frequencies despite 15 years of~     nationwide efforts by Breast Screen Singapore. The investigators aim to determine the~     efficacy of opportunistic health promotion for uptake of mammography screening in~     Singaporean women attending private sector primary care clinics in Singapore by implementing~     a simple and feasible questionnaire to identify potential candidates for mammography~     screening, coupled with recommendations by the primary care provider and a directed~     promotional video produced by Kandang Kerbau Hospital (KKH) that is aimed at addressing some~     of the barriers to screening.~   "
72506|NCT02108301|"~     The aim of the present trial is to evaluate whether the conversion of immunosuppression from~     tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters~     of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal~     transplant recipients.~   "
72507|NCT02108288|"~     OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost~     ophthalmic solution are administered once daily for 7 days and the effect on the blood~     concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating~     the combination drug will be determined.~   "
72508|NCT02108262|"~     This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,~     dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of~     multiple dose administration of two dose levels of CSL112 compared with placebo in subjects~     with acute myocardial infarction (AMI).~   "
72509|NCT02108249|"~     The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes~     of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the~     lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be~     used with commercially available pedicle screw fixation systems in order to extend existing~     pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to~     historical control.~   "
72510|NCT02108236|"~     To determine the efficacy and safety of acupuncture for obesity and overweight people in~     China.~   "
72511|NCT02108223|"~     The investigators aimed to evaluate patients who had In-vitro fertilization treatment and~     who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH~     (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The~     investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and~     the control groups regarding the results of IVF in these patients.~   "
86910|NCT01919801|"~     This study is being conducted to compare the safety and efficacy of icatibant with placebo~     in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in~     Adults.~   "
72512|NCT02108210|"~     Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no~     somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine~     network has been suspected to play a role in the pathophysiology of CFS. Although~     derangements of the cytokine network in CFS are controversial, a major problem is that many~     studies did not use adequate controls. In addition, all studies have been performed on~     peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the~     brain, the information that can be derived from peripheral blood cells is limited. The only~     information regarding the possible role of cytokines in the pathophysiology of CFS could~     come from intervention studies in which pathogenetically important cytokines are inhibited.~     A potentially relevant cytokine which can be blocked in humans without severe side effects~     is IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited~     evidence for this.~      Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS~     patients.~      Study design: A randomized placebo controlled study will be performed to determine whether~     interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.~      Study population: Female CFS patients without psychiatric co-morbidity will be included in~     this study. Patients of the outpatient clinic of the Department of General internal medicine~     and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study.~     Patients will be asked to bring a healthy neighbourhood control to their first study visit.~      Intervention: After inclusion patients will be randomized to receive one of the following~     treatments:~        -  interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);~        -  placebo for 4 weeks (N=25).~      Main study parameters/endpoints: The primary outcome measure will be fatigue severity~     measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be~     repeated up to 26 weeks.~      Secondary outcome measures will be:~        -  level of functional impairment measured with the Sickness Impact Profile (SIP8) total~          score;~        -  physical and social functioning assessed with the subscale physical functioning and~          social functioning of the SF-36;~        -  level of psychological distress assessed with the total score on the Symptom~          Checklist-90 (SCL-90);~        -  pain severity assessed with a Visual Analog Scale (VAS);~        -  cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at~          protein and mRNA level);~        -  cortisol measurement in saliva and hair;~        -  microbiome determination in faeces;~        -  body temperature and pulse rate.~   "
72513|NCT02108197|"~     The investigators hypothesize that pregnant women with gestational diabetes will have a high~     incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved~     glucose control in these women.~   "
72514|NCT02108184|"~     Comparison of the eradications rates of sequential therapy versus concomitant therapy of~     treatment of Helicobacter pylori infection in Korea.~      single center, randomized trial~        1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)~          twice for 10 days~        2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)~          twice for 14 days~        3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole~          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days~        4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole~          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days~      1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol)~     2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance~   "
72515|NCT02108171|"~     Most patients with preoperative varying degrees of stress, anxiety, which makes the stress~     response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic~     system hyperexcitability prone to cause adverse cardiovascular events and affect~     postoperative recovery. However, phenobarbital, as the traditional premedication, has less~     sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of~     respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on.~     Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative,~     anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal~     stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore,~     dexmedetomidine as premedication has certain advantages. The purpose of this research is to~     study sedative effect, safety and the impact of anesthesia recovery period of intranasal~     dexmedetomidine premedication for suspension laryngoscopy.~   "
72516|NCT02108158|"~     A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of~     different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.~   "
72517|NCT02108145|"~     Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common~     hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was~     presented in the area of the biliary duct bifurcation. Recent retrospective study included~     heterogeneous group of malignant diseases demonstrate that draining more than 50% of was~     associated with a longer median survival.~      However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting~     clinical guideline and Asia-Pacific consensus recommendations for endoscopic and~     interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment~     bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due~     to the absence of randomized controlled trials.~   "
72518|NCT02108132|"~     Hemophilia is caused by a single-gene defect resulting in familial bleeding disorder. Small~     increase in gene products could transform a severe form of hemophilia into a mild one. Stem~     cells from extrahepatic sources are being considered for clinical applications in liver cell~     therapy as they possess high in vitro culture potential and could be used in transplant~     procedures. We studied the differentiation of bone marrow hematopoietic stem cells (BM-HSCs)~     from hemophilia patients' relatives into factor 8 (FVIII)-producing hepatocyte-like cells~     aiming to expand patients' donor options for partial replacement of mutant liver cells by~     healthy cells in hemophilia A patients which could manage the severity of the bleeding~     disorder.~      BM-HSCs from hemophilic families will be cultured in short-liquid hepatic induction medium.~     Appearance of hepatic phenotype will be evaluated by alpha-fetoprotein expression using~     immunocytochemistry. Functional evaluation of transdifferentiation will be done through~     detection of albumin synthesis using microalbumin assay kit, factor VIII activity by~     one-stage clotting assay and expression of FVIII messenger RNA( mRNA) by reverse~     transcription ( RT-PCR).~      Inducing the differentiation of BM-HSCs by in-vitro manipulation may become a valuable tool~     to provide a cell source for hepatocyte transplant procedures for treatment of hemophilia~     patients.~   "
72519|NCT02108119|"~     To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.~   "
72520|NCT02108106|"~     This is a dose escalation study that will be conducted in healthy volunteers. Multiple~     cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and~     tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of~     AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the~     blood.~   "
73581|NCT02094235|"~     This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment.~     Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group~     (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years~     of age) according to the sequential cohorts by confirming the safety.~   "
72521|NCT02108093|"~     The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2)~     still remains unclear, because studies are limited in sample size and study design, and~     because of the absence of prospective studies. The investigators hypothesize that RAP limits~     the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation~     during cardiopulmonary bypass (CPB), compared to the conventional priming method.~      The primary objective of this study is to determine whether RAP limits the degree of~     hemodilution and limits prolonged intraoperative cerebral desaturation during~     cardiopulmonary bypass, compared to the conventional priming method. Prolonged~     intraoperative cerebral desaturation will be assessed by rSO2 desaturation score50. rSO2~     desaturation score50 > 3000 is associated with increased risk of cognitive decline. The~     investigators hypothesize that RAP limits the degree of hemodilution and thereby limits the~     incidence of rSO2 desaturation score50 > 3000 with a relative difference of 50%.~      The subjects who are divided in the RAP group, the retrograde autologous priming technique~     will be used, where the patient's own circulating blood partially will be replaced by the~     priming solution in the cardiopulmonary bypass. In the Control group the conventional~     priming method will be used. The main study parameters is rSO2 desaturation score50.~   "
72522|NCT02108080|"~     Background:~      - People with alcoholism have differences in their brains compared with healthy people.~     People who are dependent on alcohol also perform differently on behavioral tasks.~     Researchers want to find out more about these differences. They also want to see if these~     differences are related to DNA.~      Objective:~      - To see if differences in brain structure relate to personality and behavior differences in~     people with and without alcohol dependence.~      Eligibility:~      - Adults age 18 and older.~      Design:~        -  Participants will visit the NIH Clinical Center once during the study.~        -  Participants will be screened with a medical history, EKG, and physical exam. They will~          give blood and urine samples and undergo a psychiatric interview.~        -  Participants will be asked about their alcohol drinking, to see if they have an alcohol~          use disorder.~        -  Participants will play three computerized games. Some will play these games inside a~          magnetic resonance imaging (MRI) scanner.~        -  MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie~          on a table that slides in and out of a cylinder. They will be in the scanner for about~          90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud~          knocking noises. They will get earplugs.~   "
72523|NCT02108054|"~     Background:~      - Scientists know that alcohol use disorders affect brain structure. They want to know more~     about the effects of alcohol use disorders on a person s behavior. They want to develop~     tasks that can be done inside a scanner that can help them better understand these effects~     in later studies.~      Objective:~      - To develop tasks that investigate a person s behavior that can be used in later studies.~      Eligibility:~        -  Inpatient participants of another study. They must be physically healthy right-handed~          adults 18 60 years old.~        -  Healthy right-handed volunteers 18 60 years old.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have an~          EKG to record heart activity. They will give blood and urine samples and have a~          psychiatric interview.~        -  Participants will have between one and three visits.~        -  Participants will be asked about their alcohol drinking to see if they have an alcohol~          use disorder.~        -  Participants will complete one of three simple computerized tasks either inside the~          magnetic resonance imagining (MRI) scanner or outside of it.~        -  The MRI scanner takes pictures of the brain. The scanner is a metal cylinder.~          Participants lie on a table that can slide in and out of the cylinder. They will be in~          the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The~          scanner makes loud knocking noises, but they will get earplugs.~   "
72524|NCT02108041|"~     Background:~      How people respond to drugs depends in part on their genes. For some drugs, doctors can use~     an individuals genetic background to help in dosing the drug. Researchers want to know how~     doctors incorporate personalized or genomic medicine into clinical practice.~      Objective:~      To study how physicians make personalized treatment decisions~      Eligibility:~      Healthy adult primary care physicians who are internal (or family) medicine residents.~      Design:~      Participants will complete a screening form.~      Participants will put on a headset, called a head-mounted display, showing a virtual reality~     environment.~      The environment will contain an exam room and the virtual patient.~      After interacting with the virtual patient, participants will complete a series of survey~     measures.~      Participation will last for about 60 minutes. The virtual patient interaction and follow-up~     questions will be audio taped.~   "
72525|NCT02108028|"~     Background:~      - There are very few documents to help young adults living with advanced cancer discuss~     their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young~     adults to explain what kind of care they would want if they became unable to communicate or~     make medical decisions on their own. Researchers want to study if this document is helpful.~      Objective:~      - To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve~     communication about advanced care planning.~      Eligibility:~      - Adults 18 to 39 years old being treated for cancer.~      Design:~        -  Participants will answer questions about their age, gender, employment, religion,~          health, and marital status. They will also complete several brief questionnaires:~             1. General Anxiety Short Form~             2. Peace, Equanimity and Acceptance in the Cancer Experience~             3. Functional Assessment of Social Support~             4. Quality of Communication~             5. Prior Communication about Advanced Care Planning~        -  Then a health care professional will introduce Voicing My CHOiCES . Participants will~          review the document and comment on parts they find relevant. They will also say if any~          important items are missing. Participants will complete 3 pages of the document with~          the assistance of a health care provider. They will be asked for positive and negative~          observations.~        -  The second stage of the study will take place about 1 month later. Participants will~          repeat the brief questionnaires listed above. They will be asked if they shared any of~          the preferences they described when completing the 3 pages of Voicing My CHOiCES during~          visit 1 with a family member, friend, or health care provider. Research staff will ask~          the participant for permission to contact the people they spoke with in order to learn~          whether their conversations about the document were helpful. They will ask for feedback~          on how to make Voicing My CHOiCES more helpful.~   "
72543|NCT02107794|"~     The investigators' decision aid for patients with GD, GD Choice, will be the result of a~     user-centered participatory action research involving) synthesis of the best available~     evidence from the literature and real-world registry experience, ii) input and involvement~     of patients, clinicians and other stakeholders, iii) direct observation of encounters and~     iv) extensive field-testing. The goal is to create a decision aid that will be rigorously~     evidence-based, clear and complete, able to be used by clinicians with minimal training~     time, while satisfying extant standards for rigorous high-quality shared decision making~     tools.~   "
73650|NCT02093325|"~     The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of~     isolated chemotherapy-induced thrombocytopenia in patients with gynecologic cancer.~   "
72526|NCT02108015|"~     Objective~      Ionotropic glutamate receptors are ligand-gated ion channels responsible for most of the~     excitatory neurotransmission in the mammalian central nervous system (CNS). Based on~     pharmacology, they have been grouped into three subtypes-NMDA, AMPA and kainate. In recent~     years it has become apparent that the receptors do not function alone, but in the company of~     auxiliary proteins that regulate their activity [1]. Some of these have been shown to~     modulate AMPA receptor trafficking, gating and pharmacology and are classified as~     transmembrane AMPA receptor regulatory proteins, or TARPs ( >=-2, >=-3, >=-4, >=-5, >=-7,~     and >=-8). Genetic data indicate a possible role of TARPs in schizophrenia, depression,~     epilepsy, neuropathic pain, and bipolar disorder [1]. In a preclinical collaboration with~     Eli Lilly, we developed a promising radioligand, 18F-TARP252 to image TARP >=-8 using~     positron emission tomography (PET).~      This protocol covers three phases:~        -  Phase 1: kinetic brain imaging to quantify TARP >=-8 in brain relative to concurrent~          measurement of the parent radioligand in arterial plasma;~        -  Phase 2: if 18F-TARP252 is successful in Phase 1, we will estimate the~          radiation-absorbed doses by performing whole body imaging;~        -  Phase 3: test-retest analysis of brain binding relative to concurrent measurement of~          the parent radioligand in arterial plasma.~      Study Population~      Healthy adult female and male volunteers (n=22, ages 18 - 55) will undergo brain imaging. An~     additional eight healthy volunteers will undergo whole body dosimetry analysis.~      Design~      For quantification of TARP >=-8, 22 healthy controls will have brain PET imaging using~     18F-TARP252 and an arterial line. Some of them will have a test-retest scan. Eight~     additional subjects will have a whole body PET scan for dosimetry. For dosimetry, no~     arterial line will be used.~      Outcome Measures~      To assess quantitation of TARP >=-8 with 18F-TARP252, we will primarily use two outcome~     measures: the identifiability and time stability of distribution volume calculated with~     compartmental modeling. In test-retest study, we will calculate the retest variability. We~     will assess whole-body biodistribution and dosimetry of 18F-TARP252 by calculating doses to~     organs and effective dose to the body.~   "
72527|NCT02108002|"~     Background:~      - Von Hippel-Lindau (VHL) disease is a rare gene disease. People with VHL often have a brain~     tumor called hemangioblastoma. Standard treatment for these tumors is risky surgery.~     Researchers want to find new ways to treat people who have the tumors. They want to see if a~     drug that fights other cancers might slow the growth of hemangioblastomas in some people~     with VHL. Some people with VHL have mutations that make abnormal proteins. Tumors form in~     such people because the abnormal protein is broken down quickly. The cancer drug may work in~     these tumors by preventing breakdown of protein.~      Objective:~      - To study how the drug vorinostat affects hemangioblastomas in people with VHL.~      Eligibility:~      - Adults at least 18 old with hemangioblastomas from VHL.~      Design:~        -  Participants must already be in study 03-N-0164. They must have tumor surgery~          scheduled.~        -  Participants must stop taking most medications 14 days before surgery.~        -  One week before surgery, participants will enter the hospital. They will be screened~          with medical history and physical and neurological exams. They will give blood and~          urine samples. Participants will have an electrocardiogram. For this test, small sticky~          patches are put on the arms, legs, and chest. Participants will lie still for a few~          minutes while a machine records heart rate and rhythm.~        -  Participants will take one vorinostat by mouth each day for 7 days.~        -  Participants will have blood drawn during the week to check for any side effects.~        -  Participants will have their tumor removed in surgery. Researchers will study the tumor~          tissue for the effects of the study drug.~        -  A nurse will call participants 1 month after surgery to check for side effects.~   "
72528|NCT02107989|"~     Objectives:~      The overall study objective is to compare the sensitivities and specificities of~     morphometric analysis techniques using structural MRI images based on pre- and postsurgical~     localization of epileptic foci in patients undergoing presurgical evaluation for medically~     refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified~     normative imaging database using healthy volunteers. Additional objectives are to identify~     abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use~     language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on~     cognitive function and the networks associated with these functions.~      Study population:~      150 adults and children (age 8-65) with uncontrolled focal epilepsy, and 100 age-stratified~     healthy volunteers.~      Design: A retrospective and prospective natural history study. Research procedures for~     patients in this study include neuropsychological testing and 1-4 MRI sessions during~     presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing~     approximately 12 months post-operatively. Research testing (such as research~     neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical~     testing whenever possible, likely reducing the number of required visits. Patients will also~     have optional MEG and 7T structural imaging. Data will also be obtained from patients who~     have already undergone epilepsy surgery if they had procedures as outlined in the protocol~     and are willing to share the data. Healthy volunteers will receive a subset of the~     pre-operative procedures for patients, requiring at least 3 visits. In order to ensure~     adequate data acquisition, subjects may be re-scanned up to three times for the portions of~     the study in which they participated, possibly requiring additional visits.~      Outcome measures:~      The main outcomes will be establishment of normative values for morphometric analysis~     methods in age-stratified normal controls, and comparison of the sensitivity and specificity~     of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary~     outcome measures will include determination of the sensitivity and specificity of source~     localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation~     during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically,~     to examine the effects of epileptogenic zones and surgery on cognitive function and the~     networks underlying these functions.~   "
72529|NCT02107976|"~     Diabetes type two is a debilitating disease that leads to chronic morbidity such as~     accelerated microvascular disease. Accelerated microvascular disease may produce blindness,~     end stage renal disease, myocardial infarction, stroke, and limb ischemia. Strategies to~     prevent or delay microvascular disease have the potential to improve the lives of millions~     and prevent catastrophic illness. The major focus of prevention of microvascular disease in~     diabetes has been on the endothelium and its role in protection of blood vessels. An~     unexpected means to prevent microvascular disease in diabetes may be coupled to the function~     of vitamin C in red blood cells (RBCs) of diabetic subjects. Based on new and emerging data,~     vitamin C concentrations in RBCs may be inversely related to glucose concentrations found in~     diabetes. Based on animal data, we hypothesize that RBCs with low vitamin C levels may have~     decreased deformability, leading to slower flow in capillaries and microvascular hypoxia,~     the hallmark of diabetic microangiopathy. Low vitamin C concentrations in RBCs of diabetic~     subjects may be able to be increased, by using vitamin C supplements. Findings in animals~     may not accurately reflect effects in humans because of species differences in mechanisms of~     vitamin C entry into RBCs. Therefore, clinical research is essential to characterize vitamin~     C physiology in RBCs of diabetic subjects. In this protocol we will investigate physiology~     of vitamin C in RBCs of diabetic subjects as a function of glycemia, with and without~     vitamin C supplementation. We will screen type II diabetic subjects on insulin and select~     those with low vitamin C levels and hemoglobin A1C concentrations of 8-12%. Selected~     subjects will be hospitalized twice, each time for approximately one week. As inpatients,~     subjects will have two venous sampling periods each of approximately 24 hours. For the first~     sampling period, controlled hyperglycemia will be induced by withdrawing insulin and~     providing a high carbohydrate load diet (70-75% carbohydrate). Hyperglycemia will not exceed~     9 hours, and will be reversed by reinstituting insulin. The second sampling period, also for~     24 hours, will be performed under conditions of euglycemic control.~      During the two sampling periods, samples will be withdrawn via venous catheter for RBC~     deformability and vitamin C concentrations. At discharge, subjects will be placed on a~     vitamin C supplement and seen as outpatients at weekly intervals. After 3 or 6 weeks~     (depending on RBC vitamin C levels), subjects will be hospitalized again, and sampling~     repeated as described. In this manner, each subject serves as his/her own control, and~     deformability of red blood cells can be determined in relation to glycemia and to vitamin C~     concentrations in RBCs and plasma.~   "
72544|NCT02107781|"~     The investigators will monitor the pressure generated inside the abdomen in a patient in~     whom the surgeon, for whatever reason, felt that the abdomen could not be closed at the~     initial operation. The investigators will aggressively treat rises in intra-abdominal~     pressure and see what changes, if any are found when the abdomen finally is closed.~   "
72545|NCT02107768|"~     The purpose of this study was to investigate the effects of early intensive aerobic exercise~     regarding aerobic capacity, gait and balance, Health Related Quality of Life and~     participation.~   "
73651|NCT02093312|"~     The overall objective of the study is to investigate the effect of energy- and protein~     enriched home delivered meals vs. habitual diet in malnourished patients suffering from~     cancer on various endpoints.~   "
72530|NCT02107963|"~     Background~      GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on~     osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric~     antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients~     with refractory neuroblastoma.~      A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise~     for increased activity compared to the 1st generation GD2-CAR already studied in clinical~     trials. As an added safety measure, the vector includes a suicide switch comprising a~     caspase dimerization domain (ICD9) that can be activated by a small molecule to induce death~     of the genetically engineered cells if they were induce untoward toxicity.~      Objectives~      Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established~     release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR~     engineered T cells in children and young adults with GD2+ solid tumors, including~     neuroblastoma, following cyclophosphamide-based lymphodepletion.~      Secondary:~        1. Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects~          in children and young adults with GD2+ solid tumors;~        2. Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this~          with antitumor effects;~        3. Extend information regarding the prevalence and intensity of GD2 expression in~          non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults;~        4. If unacceptable toxicity occurs that is possibly, probably or likely related to~          anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate~          clearance of the genetically engineered cells and resolve toxicity; and~        5. Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells.~      Eligibility~      Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor~     (including neuroblastoma) that has recurred after or not responded to standard therapy and~     is deemed incurable by standard therapy.~      Design~      After apheresis to collect T cells for transduction, patients receive cyclophosphamide~     1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used~     at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x~     10(6) transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3~     dose escalation design. An expanded group of a total of 12 patients will be treated at the~     highest dose, comprising at least 6 osteosarcoma patients.~      Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T~     cells.~      Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60~     days following completion of the first cycle if eligibility criteria are met.~      A maximum of 36 patients may be treated on this study. Given that there is likelihood that~     some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be~     eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36~     patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this~     study may require up to 2-3 years to complete enrollment and treatment.~   "
72531|NCT02107950|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy~     (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of~     progression free survival (PFS).~   "
72532|NCT02107937|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy~     (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of~     progression free survival (PFS).~   "
72533|NCT02107924|"~     The purpose of the study is to gather information on the use of Stimulan, the surgery, and~     anitbiotics to whetether the APPI has decreased or shown improvement when compared to study~     participants who did not receive Stimulan during their revision total knee replacement~     surgery.~   "
72534|NCT02107911|"~     The potential participants will be informed of the study details, including the study~     objectives. Once they have read the study information sheet and have a good understanding of~     the study, those who intend to participate in the study will be asked to sign the consent~     form for this study. There are 2 groups of participants: MSM who seek HIV voluntary~     counseling and testing service (phase I) and MSM who meet nPEP criteria (phase II).~   "
72535|NCT02107898|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable daily statin therapy with or without other lipid modifying therapy~     in comparison with placebo after 24 weeks of treatment in heterozygous familial~     hypercholesterolemia (HeFH) or high cardiovascular risk participants with~     hypercholesterolemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks~          of treatment.~        -  To evaluate the effect of alirocumab on other lipid parameters.~        -  To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C~          after 52 weeks of treatment.~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics of alirocumab.~   "
72536|NCT02107885|"~     This is a randomised, double-blind, placebo-controlled and ascending single dose study. It~     is hypothesised that single oral doses of DS-1971a within the planned dose range will be~     safe and well tolerated by healthy male subjects.~   "
72537|NCT02107872|"~     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose~     study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and~     pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.~   "
72538|NCT02107859|"~     This is a Phase 3, multicenter, open-label, safety and efficacy study of ataluren in~     patients with nonsense mutation cystic fibrosis who participated in the previous Phase 3~     study with ataluren (PTC124-GD-009-CF; Study 009).~   "
72539|NCT02107846|"~     This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and~     pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement~     therapy. The dose levels of PRX-112 are 50 units, 100 units, 200 units and 400 units GCD.~     Subjects will receive once daily oral administrations of PRX-112 for 5 consecutive days at~     each dose level with a 2-day washout period between doses.~   "
72540|NCT02107833|"~     : This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in~     healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be~     randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106~     doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein.~     Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days.~     Subjects will remain at the clinical center for 24 hours after the first administration (Day~     1) of OPRX-106 including PK sampling and then return to the site daily for additional~     administrations and study procedures.~   "
72541|NCT02107820|"~     Overactive Bladder (OAB) is a chronic condition defined as urgency with or without~     incontinence usually associated with frequency and nocturia. It is a common condition~     affecting 15-45% of adults and constitutes a significant proportion of patients attending~     urogynaecology clinics. OAB is known to have a significant impact on the physical, social~     and emotional quality of life and sexual function in women. The treatment of OAB is~     initially conservative with bladder training followed by pharmacotherapy.~      Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of~     anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to~     improve with these initial measures are offered Intravesical Botox or neuromodulation in the~     form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).~      PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In~     2010 National Institute of Clinical Excellences (NICE) issued guidance stating 'PTNS for~     OAB demonstrates effectiveness without major safety concerns~      We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with~     bladder training (BT).~   "
72546|NCT02107755|"~     This phase II trial studies the effectiveness of the combination of stereotactic radiation~     therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer~     sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external~     beam radiation therapy that uses special equipment to position the patient and precisely~     give a either a single large dose of radiation therapy to a tumor or several large doses of~     radiation therapy to a tumor using precision and accuracy that is guided by onboard daily~     imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block~     tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together~     with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be~     presented to the immune system.~   "
72547|NCT02107742|"~     This study will investigate the influence of injection speed on pain during injection of~     lidocaine. It is anticipated that a longer injection time will lead to less pain for the~     patient during the injection. This hypothesis will be tested on healthy volunteers, who will~     each receive three injections with the same amount of lidocaine subcutaneously on the~     abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the~     subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of~     the study is to find a simple method for pain reduction that can be used in clinical~     practice.~   "
72548|NCT02107729|"~     This study will investigate the influence of needle gauge on pain during injection of local~     anaesthetic. Healthy volunteers will be recruited, who will each receive three injections~     with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the~     participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is~     anticipated that the pain will decrease with decreasing thickness of the needle. The aim of~     this study is to find a simple method for pain reduction that can be used in clinical~     practice.~   "
72549|NCT02107716|"~     This study will investigate the influence of adjusting the pH of lidocaine on pain during~     subcutaneous injection. Each participant will receive two injections on the abdomen with~     different pH. After each injection, the subject will be asked to evaluate the pain on a~     Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing~     pH. The aim of the study is to find a simple method for pain reduction that can be used in~     clinical practice.~   "
72550|NCT02107703|"~     The main purpose of this study is to compare progression-free survival for women with~     hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative~     advanced breast cancer receiving either abemaciclib+fulvestrant or fulvestrant alone.~     Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will~     last about 9 months for each participant.~   "
72551|NCT02107690|"~     This study will investigate the influence of lidocaine temperature on pain during injection~     of lidocaine. Each participant will receive three injections subcutaneously on the abdomen~     with different temperatures. After each injection, participants will be asked to evaluate~     the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with~     increasing temperature. The aim of the study is to find a simple method for pain reduction~     that can be used in clinical practice.~   "
72552|NCT02107677|"~     This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference~     tests (e.g. PCR or viral culture) for dengue diagnosis in the US.~      DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages~     of Dengue infection in patients with clinical symptoms consistent with Dengue infection.~     This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV~     Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing~     with a reference standard test.~      This study will use archived, leftover human serum samples that have been sequentially~     collected from areas non-endemic for Dengue infection. Each specimen must have been~     collected within the first 7 days of symptoms, and must be accompanied by clinical data~     demonstrating that the individual had symptoms consistent with Dengue infection. The samples~     will have no personally identifiable information.~      ELISAs and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples~     from each method independently.~   "
72553|NCT02107664|"~     Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to~     metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no~     established predictors that can be used to select patients that respond to RT. This raises~     the need to identify potential clinical characteristics and biomarkers that may better~     select patients for RT. A similar argument can be stated for the development of cachexia;~     there are currently no predictors that can identify patients who will develop cachexia later~     in the cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain,~     cachexia and depression are associated with inflammation in experimental and preclinical~     studies . Still, the clinical data on the relationship between inflammation and pain or~     cachexia are sparse. This is especially true for longitudinal follow-up studies.~      This study will include 1000 adult patients in a multicenter, multinational longitudinal~     observation study of patients who receive radiation therapy for bone cancer pain.~     Demographic data, clinical variables, genetic biomarkers and inflammatory substances will be~     assessed before start of RT. The primary analysis in the study is to identify potential~     predictors for pain relief from RT. During follow up the study will also explore for~     predictors for development of cachexia and which inflammatory substances that are associated~     with changes in pain intensity, depression and development of cachexia.~   "
72554|NCT02107651|"~     Serious adverse events in patients treated with new oral anticoagulants are underreported.~   "
72569|NCT02107456|"~     Myofascial trigger point is one of the most common causes of musculoskeletal disorders.~     Myofascial trigger point in upper trapezius has been reported as a symptom in patients with~     neck and upper thoracic pain. The purpose of this study was to investigate the prolonged~     effect of dry needling on myofascial trigger point in upper trapezius muscle.~   "
72777|NCT02104739|"~     This project addresses cardiovascular disease risk in patients with prediabetes. Levels of~     lipids after eating a meal (postprandial lipids) are strong independent predictors of~     cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid~     metabolism. These medications will be studied for their effect in reducing both postprandial~     lipid levels and arterial dysfunction.~   "
72555|NCT02107638|"~     Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that~     affects the patient's mobility, balance and cognition. Tremor, slowed movements, and~     rigidity are physical symptoms which contribute to postural and gait abnormalities seen in~     many PD patients. Other symptoms include loss of balance and restricted range of motion,~     increasing the risk of falling. Osteopathic manipulative medicine (OMM) is a form of manual~     treatment provided by osteopathic physicians. This form of treatment aims to help decrease~     muscle spasms and improve joint range of motion and movement. We are proposing a pilot study~     to investigate the impact of OMM on balance, motor function, and falling in PD patients. We~     are also going to screen for serum biomarker changes to investigate the potential effects of~     OMM. Our research team and institution have experience in providing osteopathic care and~     physical rehabilitation for PD patients. In this study, balance and motor function will be~     evaluated for each subject throughout the study period. We will also keep track of the~     number of falls. Balance will be measured using Sensory Organization Test (SOT) and motor~     function will be measured using Movement Disorder Society Unified Parkinson's Disease Rating~     Scale (MDS-UPDRS). Both tools are non-invasive and clinically proven methods for measuring~     balance and motor function.~   "
72556|NCT02107625|"~     The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented~     Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS~     patients compared to traditionally dietary advice in IBS. The study also aim to investigate~     patients compliance to either dietary advices. Further, the investigators aim to find out if~     IBS patients with different symptoms are alleviated in different ways, to be able to~     individualize the dietary advices to result in a more optimal symptom relief in each patient~     in the future.~   "
72557|NCT02107612|"~     The purpose of this study was to evaluate the effect of a integrated system for inserting~     two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality~     of life of edentulous patients.~   "
72558|NCT02107599|"~     This study will evaluate whether the addition of quantitation as an adjunct to visual~     interpretations significantly improves the accuracy of Amyvid scan interpretation.~   "
72559|NCT02107586|"~     The purpose of the study is to determine what the different outcomes are for biceps~     tenodesis and tenotomy in the treatment of the long head of the biceps pathology.~   "
72560|NCT02107573|"~     The purpose of the study is to compare the differences in outcome between the traditional~     rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression~     surgery.~   "
72561|NCT02107560|"~     Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no~     obstruction, however, it can be infected with bacteria when there is a stasis or~     obstruction. After infection, cholangitis can be developed because of systematic endotoxemia~     or bacteremia. Though identification of bacteria is very important for selection of adequate~     antibiotics, treatment with empirical antibiotics is commonly performed when identification~     of bacteria is not possible.~      Identification of bacteria is usually done with blood or bile culture. In the previous~     studies, the same results from blood and bile were common in patients with cholangitis.~     However, the data of these studies were based on the bile juice which was aspirated by~     surgery. Considering that bile duct obstruction is usually treated with endoscopy or~     radiological intervention without surgery, it is necessary to collect data with endoscopic~     or radiologic intervention. In addition, the concordant rate of these two tests has not been~     reported according to severity of cholangitis. As a result, the necessities of bile and~     blood culture are not agreed among experts in this fields.~      Our hypothesis is that concordant rates of bile and blood culture are same in patients with~     each moderate or severe cholangitis. However, the concordant rates of bile and blood culture~     are different between patients with moderate and severe cholangitis. This study will assess~     the positive rates of blood and bile culture in patients with moderate or severe~     cholangitis, respectively and compare the results according to the different severity.~   "
72562|NCT02107547|"~     The purpose of the study is to determine which of the two alternative surgical interventions~     (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior~     Labrum Anterior and Posterior lesions.~   "
72563|NCT02107534|"~     Children with dyslexia show a variety of comorbid disorders like behavior and adaptive~     disorders, hyperkinetic and anxiety disorders. Raising and educating a child with dyslexia~     is a challenging task for parents. Studies show that parents of children with dyslexia~     suffer under depressive symptoms and higher parenting stress. In order to support the~     child's academic development many parents of children with dyslexia practice reading and~     writing more often and show controlling and maladaptive behavior. As a result learning~     motivation of the child decreases and later homework situations are influenced in a negative~     way.~      Consequently, it is necessary to provide parent training on appropriate behavior with~     homework and academic exercises, in order to raise parent's competences, reduce parenting~     stress and promote learning motivation of the child. In the German-speaking area there is a~     lack of elaborated and evaluated programs for parents of dyslexic children. Therefore, a~     group program that especially addresses the needs of these parents was devised. The study~     aims at evaluating the effects of the parent training. We hypothesize that the treatment~     reduces parenting stress and raises competences of the parents.~      Forty-one mothers of third graders with dyslexia were randomly assigned to the group-based~     parent training program (N=25) or a waiting list control group (N=16). Only children who~     performed in the normal range on the test measuring cognitive abilities (IQ > 70) and who~     scored below average in at least one test measuring reading or writing (T-Score < 40) were~     included. Children with significant deficits in hearing or vision, pervasive developmental~     disorder or genetic disorders were excluded. Data of children and their mothers were~     collected prior to intervention, directly after intervention and three months after~     intervention. For investigating training effects at all time points parenting stress and~     competences in supporting academic development, mastering homework situations and attachment~     to the child were measured. Parents of the waiting list control group had the possibility to~     take part in the parent training after the follow-up was completed.~      The intervention program consists of five two-hour sessions held biweekly. The training~     lasts about 10 weeks. It is designed for group sizes of three to ten persons. It follows a~     cognitive-behavioral approach. The training aims at knowledge transfer about dyslexia,~     raising parent's empathy for the child's difficulties in reading and writing, promoting~     parent's competencies and self-efficacy in handling dyslexia within the family context and~     during homework situations, sensitization for opportunities of integrating reading and~     writing into daily life and reduction of parental stress. The main topics covered are~     requirements and phases of acquisition of written language, the causes of dyslexia, helpful~     strategies for managing homework and exercises, facilitation of literacy in everyday life~     and dealing with dyslexia. Methods used are brief lectures, example cases, group discussions~     and practice, as well as homework tasks. Written handouts summarizing important topics are~     given at every session.~      A benefit of enrolling in the study is that parents get information concerning the academic~     development of their children. At the moment it is not sure whether parents profit from~     participating in the training because effects have not been investigated yet. The study~     takes place at the University of Heidelberg (Children's Hospital) and the Early Intervention~     Centre in Heidelberg. The study started in January 2012 and is expired to end in October~     2014. Participants have been recruited two times, at the beginning of a school year. The~     timeline for every study flow was similar. Pretests took place in September and October;~     parent training started in December and lasted until February. Post-Test took place in~     February and March. Follow-Up measurements were realized from June to July. The study is~     funded by the Günter Reimann-Dubbers foundation of Heidelberg. The main contact for the~     study is Bettina Multhauf (M.Sc. Psych.), e-mail: fruehinterventionszentrum@googlemail.com~   "
72564|NCT02107521|"~     There is a lack of clarity regarding the justification to instruct the couple to shift from~     intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm~     injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with~     previous implantation failure with ICSI.~   "
72565|NCT02107508|"~     Obesity is increasing rapidly all over the world not only in adults but also among children.~     As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended~     during physical activity plays an important role in preventing weight gain. Decreased~     physical activity, coupled with an over-consumption of calories, lead to the change of body~     composition by storing energy as fat.Although several studies have simultaneously examined~     body composition with energy expenditure the independent roles of body composition with~     activity energy expenditure (AEE) are less firmly established. It's suspected shrewdly that~     energy expenditure is partly influenced by the body composition. The aim of the study is to~     examine the relation of AEE with body composition in a population of school-age children.~   "
72566|NCT02107495|"~     To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in~     intended use settings, by comparing test results of the A20 CHF Test with results obtained~     from an FDA-cleared comparator assay.~   "
72567|NCT02107482|"~     The purpose of the study is to test the effect of a localized narrow band ultraviolet~     (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance~     of psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy~     device is cleared by the U.S Food and Drug Administration (FDA).~   "
72568|NCT02107469|"~     The purpose of the study is to determine whether phyllanthus niruri and sida cordifolia are~     effective in treatment of diabetic polyneuropathy compared to placebo. Also two different~     administration forms (extract capsules and crude herbs) are used to find out whether there~     are differences in efficiency and compliance.~   "
72653|NCT02106351|"~     The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport~     used in the treatment of upper limb spasticity (altered skeletal muscle performance) in~     children with cerebral palsy (CP).~   "
72570|NCT02107443|"~     This randomized clinical trial studies standardized geriatric assessment (GA) or usual care~     in improving communication and quality of life in older patients with advanced solid tumors~     or lymphoma and their caregivers. A GA measures the issues important to older patients,~     including function, psychological status, cognitive abilities, social support, and the~     impact of medical problems on quality of life. A GA may improve communication between~     patients and their doctors in addressing patient concerns. It is not yet known whether a~     standardized GA is more effective than usual care in improving communication and quality of~     life in older patients with solid tumors or lymphoma.~   "
72571|NCT02107430|"~     The purpose of this study is to determine whether DCVAC/PCa added after radical primary~     prostatectomy can improve PSA progression times within 5 years for patients with high risk~     localized Prostate Cancer.~   "
72572|NCT02107417|"~     This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation~     (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer~     patients who have Chemotherapy-induced peripheral neuropathy (CIPN).~   "
72573|NCT02107404|"~     The purpose of this study is to determine whether DCVAC/PCa added after radical primary~     prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.~   "
72574|NCT02107391|"~     The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can~     improve PSA progression times for patients with Metastatic Prostate Cancer.~   "
72575|NCT02107378|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may~     result in prolongation of Overall Survival (OS).~   "
72576|NCT02107365|"~     Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients~     infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard~     treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination~     with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment~     in non-responders genotype 1-infected patients.~      Given the absence of current solutions and urgent therapeutic needs for HCV genotype~     4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study~     aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir,~     Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat~     population.~      60 subjects will be enrolled.~      The primary endpoint will be the rate of sustained virological response (SVR), defined by an~     undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).~   "
72577|NCT02107352|"~     The main aim of this research is to investigate whether the use of cognitive event-related~     potentials is an interesting way to identify subgroups of alcoholic patients displaying~     specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt~     the pharmaceutical approach to the specific needs of the patient.~      Nowadays, a fundamental question remains: How can investigators identify among alcoholic~     patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and~     those who are not? The goal of this application is to identify subgroups of alcoholic~     patients displaying specific clinical symptoms and cognitive disturbances linked to~     consistent biological markers. Investigators propose that this might help clinicians improve~     their treatment of alcoholic patients by focusing therapy on individual cognitive~     disturbances, and by adapting pharmaceutical approaches to the identified brain~     pathophysiology. In other words, investigators suggest that specifying the cognitive profile~     of each individual patient may help clinicians in their choice of a suitable drug program.~      To reach this aim, investigators suggest that a joined investigation of early (P100) and~     late (P300) brain event-related potentials (ERP) components may help create subgroups of~     alcoholic patients with homogenous cognitive deficits, and that this ''classification''~     might help optimize drug treatment. More precisely, investigators suggest that relapse in~     chronic alcoholism is partly due to (1) the preferential attentional allocation to~     alcohol-related information (e.g. the sight of a bottle of wine). As the P100 component has~     already been shown to be enhanced by motivationally relevant stimuli, investigators think~     that this component is well-suited for this purpose; and (2) the impairment of the~     inhibitory control, which is necessary to suppress an inappropriate prepotent response. The~     Go/No-Go task is a simple procedure, which has already proven to be highly reliable to~     evidence a deficit in inhibitory control processing in alcoholics, indexed by a No-Go P3 of~     decreased amplitude and less anterior topography. In summary, investigators have two simple~     experimental procedures, an oddball task and a Go/No-Go task, which can be easily carried~     out in clinical settings, and which can provide interesting data concerning, respectively,~     the existence of an implicit attentional bias towards alcohol-cues and the deficit of~     inhibitory control towards a prepotent response, through the observation of well-known and~     well-described cognitive ERP components, i.e. the P100 and P3b components. The main goal of~     this project will be to test the effect of different drug medications on both attentional~     (P100) and inhibitory (P300) deficits observable in alcoholic patients.~   "
72578|NCT02107339|"~     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain~     during the first 2-3 days following the operative procedure. Pain complicates the recovery~     process, despite the routine practice of using potent opioid analgesics. The primary reason~     that pain is poorly controlled in patients undergoing major surgery is that most~     commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these~     drugs results in periods of time when a patient will experience discomfort (at which time a~     nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is~     pressed to deliver more medication). The use of a long-acting opioid may be advantageous in~     the perioperative setting. Methadone is an opioid that has a median duration of analgesia of~     24-36 hours. Therefore, a single dose administered in the operating room may reduce the need~     for pain medication and improve pain control for the first few postoperative days. The aim~     of this randomized clinical trial is to examine the effect of methadone (compared to~     hydromorphone) on postoperative pain management in patients undergoing major spine surgery~   "
72579|NCT02107326|"~     The purpose of this study is to evaluate the impact of a software for smartphones and~     tablets on type 1 diabetes control and quality of life~   "
72580|NCT02107313|"~     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose~     of PBT2 administered to healthy volunteers in the presence and absence of food.~   "
72581|NCT02107300|"~     To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients~     undergoing CPAP therapy for OSAS and improve CPAP compliance~   "
72582|NCT02107287|"~     Considering the promising results with hypofractionated in low and intermediate risk~     prostate cancer, our proposal is to translate this experience to patients with high risk~     prostate cancer. Patients with high risk disease would receive hypofractionated RT to the~     prostate and to the external and internal iliac lymph nodes using IMRT plus long-term~     hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity~     is acceptable and similar to published data using hypofractionated technique in the prostate~     only.~   "
72583|NCT02107274|"~     Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the~     airways. Only a small number of clinical studies have been conducted investigating the use~     of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to~     determine the efficacy of 12 weeks treatment with azithromycin in adult patients with~     non-cystic fibrosis bronchiectasis.~   "
72584|NCT02107261|"~     The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®).~     Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves,~     inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In~     musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be~     critical for the musical professional to continue his or her career. With the use of~     EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize~     the individual muscles that are affected in this condition with great accuracy. Prior~     studies have shown that BoNT injections produce beneficial effects in forearm muscles, and~     less effect in shoulder or proximal arm muscles.~      Possible risks in treating patients with BoNT include excessive weakness of the injected~     muscles. The drug may also affect non-targeted muscles. However these risks will be~     minimized during the screening period by carefully targeting the affected muscles and by~     administering low doses of BoNT. Small booster doses may be given at follow up visit (2, 4,~     14 and 16-weeks after the primary injection date) if the initial injection was insufficient~     to produce sufficient efficacy in relief of the focal dystonia and did not produce excess~     weakness of the targeted muscle.~   "
72585|NCT02107248|"~     Aim of the current study is to test the non-inferiority hypothesis of differences in early~     hip dislocation between a group of patients who will be restricted to sleep in supine~     position and a group without restricted sleeping position during the first eight weeks after~     a total hip replacement following a posterolateral surgical approach~   "
72586|NCT02107235|"~     The working hypothesis is that oral rigosertib treatment when added to platinum-based~     Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with~     intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck~     Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib~     that can be used with cisplatin and CRT. This study will also record any side effects that~     may occur and measure tumor sizes and how long patients live.~   "
72587|NCT02107222|"~     A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump~     Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction~     with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in~     Patients with COPD Exacerbation and Respiratory Failure~   "
72588|NCT02107209|"~     The clinical utility of bronchoscopic methods for achieving lung volume reduction has been~     evaluated in patients with advanced emphysema because these procedures are uniformly safer~     than surgical volume reduction. These include one-way valves, or bronchial occlusive devices~     to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to~     improve expiratory flow, wire coils implants that compress the airway and thermal vapor~     ablation that causes an acute injury with subsequent fibrosis and reductions in volume.~   "
72589|NCT02107196|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as~     compared to placebo in women with IBS-D over a 12-week treatment period.~   "
72590|NCT02107183|"~     The purpose of this study is to determine whether, as compared with the Venturi mask, a~     nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in~     patients needing oxygen therapy after extubation.~   "
72591|NCT02107170|"~     Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis~     obliterans of lower extremities are two kinds of common surgeries in the investigators'~     hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive~     function, are not clear. In this study investigators propose to measure postoperative~     cognitive function and other outcome of patients who are undergoing these two kinds of~     surgeries, and try to identify whether there is an association between different kinds of~     anesthetics and postoperative outcome. Investigators will also observe whether changes in~     plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative~     delirium or cognitive change.~   "
72592|NCT02107157|"~     The purpose of this study is to assess treatment of facial rejuvenation using the standard~     hand piece and a Lens Array for the 755nm Alexandrite laser.~   "
72593|NCT02107144|"~     The study should enrol 50 patients with stable coronary artery disease scheduled for~     elective percutaneous coronary intervention of single, de novo lesion of native coronary~     artery. Patients will be randomized to orally given trimetazidine on top of standard medical~     therapy for stable coronary artery disease versus standard therapy only. The randomization~     will begin 48 hrs before intervention. Index of microcirculatory resistance (IMR) will be~     measured by thermodilution method using coronary pressure and temperature wire before and~     after stent implantation. Echocardiography will be performed before intervention and within~     30 minutes after intervention. Patients will be followed clinically for a period of one~     year.~   "
72594|NCT02107131|"~     Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on~     day-to-day visual function in patients with Diabetic Macular Edema (DME).~   "
72595|NCT02107118|"~     Men who present with erectile dysfunction as defined as an IIEF (International Index of~     Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular~     disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion~     for treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from~     all patients and stem cells will be cultured. For those patients in the placebo arm the stem~     cells will be frozen for later use after one year when the patients cross over into the~     treatment arm.~   "
72596|NCT02107105|"~     The goal of this study is to learn about quality of life in patients who have or have had~     rectal cancer.~   "
72654|NCT02106338|"~     This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple~     ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA~     synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and~     will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects~     18 to 45 years, inclusive. The primary objective: of the study is to determine the safety~     and tolerability of escalating doses of CRS3123 following oral administration of multiple~     doses to healthy adults. The study duration is 46 weeks.~   "
72597|NCT02107092|"~     Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29~     visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l~     inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and~     have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on~     Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the~     option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study~     ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator~     decision) will not be entered into study ZS-004E. All subjects who continue into the~     extension study must begin dosing within two (2) days after the last dose of investigational~     product in ZS-004.~   "
72598|NCT02107079|"~     The circadian rhythm, the sleep-wake cycle, is mainly regulated by melatonin. The synthesis~     of melatonin is stimulated by the absence of light, leading to peak serum levels before~     bedtime. In humans, this endogenous signaling neurohormone induces sleep. Exogenous~     melatonin can be beneficial in different sleep disturbances including delayed sleep phase~     insomnia, melatonin- deficiency-related insomnia (especially in elderly) and shift work~     sleep disorder. Melatonin is known for its low and variable bioavailability in humans due to~     a high first pass effect and variable pharmacokinetics and short half-life. In order to~     prevent exposure of patients with unnecessary high dosages of melatonin and in order to~     achieve a short Tmax and high bio-availability of melatonin, a proper formulation needs to~     be defined. This study, a three-phased cross-over study, aims to define a proper formulation~     for oral and oromucosal melatonin for the treatment of insomnia by investigating the Tmax~     and relative bioavailability derived from melatonin levels in salivary samples of healthy~     volunteers after administration of melatonin in different formulations: 2,5mg melatonin~     immediate release capsule (produced by Apotheek UMCU), 1mg melatonin immediate release~     tablet (produced by Tiofarma), low-dose 0.1mg melatonin original Sleepzz tablet (produced by~     Vemedia Manufacturing BV).~   "
72599|NCT02107066|"~     Despite an increase in longevity, surviving ovarian cancer often brings an array of~     unpleasant side effects and compromises in QOL. Our proposed trial will be the first study~     to test whether exercise compared with attention control has a beneficial impact on quality~     of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique~     and important role for exercise in ovarian cancer care given that physical and functional~     aspects of QOL are often the most compromised in ovarian cancer patients.~   "
72600|NCT02107053|"~     Atherosclerosis and its related cardiovascular morbidity and mortality, underlie many~     chronic diseases. Most atherosclerotic patients have multiple cardiovascular risk factors,~     which potentiate each other, causing a huge burden on health systems. In order to improve~     the understanding and treatment options of atherosclerosis, it is necessary to identify~     common basic pathways in its pathogenesis. Oxidative Stress (OS) has a major role in the~     pathogenesis of atherosclerosis; however, good biomarkers to determine OS are still missing.~   "
72601|NCT02107027|"~     The aim of this study is to compare two type of ablation catheters for pulmonary veins~     isolation (PVI) in subjects with atrial fibrillation.~      Currently, two technologies of irrigated ablation catheters are available for PVI.~      One of the two, the conventional catheter is widely used for atrial fibrillation (AF)~     treatment but has not been specifically created for pulmonary veins isolation, therefore,~     point by point encircling lesions are cumbersome and time consuming.~      The second is a new ablation catheter with a circular shape provided with 10 irrigated~     electrodes designed to create encircling lesions, necessary to obtain pulmonary veins~     isolation, could allow an easier and faster isolation compared to the conventional way.~      These two types of catheters have never been compared for atrial fibrillation. If one of the~     two catheters appears to be more efficient or causes fewer complications, the use of this~     catheter could be favored to conduct AF ablation.~   "
72602|NCT02107014|"~     We have found that low dose naltrexone (LDN) can substantially reduce pain associated with~     fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The~     purpose of this study is to determine if LDN lowers inflammatory markers in individuals with~     fibromyalgia.~   "
72603|NCT02107001|"~     Chest pain is an alarming symptom and one of the most frequent causes of access to the~     Emergency Departement. Although chest X-ray remains an essential step in the diagnostic~     process, several studies showed numerous limitations of radiography which frequently is~     inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of~     ultrasound, the utilization of ultrasound in the study of the lung has only recently been~     introduced in the clinical practice. Several studies proved that lung ultrasound is useful~     in the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound~     is not routinely used in the presence of chest pain. Our hypothesis based on clinical~     experience is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive~     in detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better~     than radiography. The primary aim of this study is to verify, in patients affected by~     pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary~     aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung~     consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.~   "
72604|NCT02106988|"~     The goal of this clinical research study is to learn if radiation therapy and chemotherapy~     can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and~     chemotherapy combination will also be studied.~   "
72605|NCT02106975|"~     Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ~     failure as measured by Sequential Organ Failure Assessment (SOFA) score,~      Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by~     the oxygenation index and the VE40~      Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive~     Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar~     epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a~     fibrinolytic state (Tissue Factor Pathway Inhibitor).~   "
72606|NCT02106962|"~     This study will investigate how the use of Tranexamic acid and Bacitracin applied to the~     bleeding site after the hemodialysis fistula needle is removed will affect skin wound~     healing.~   "
72607|NCT02106949|"~     The study wants to prove that SMS monitoring reduced the number of suicide attempts in six~     months according to the beginning of its implementation in the group of the patients~     benefiting SMS compared with the group of patients benefiting from the usual care.~   "
72608|NCT02106936|"~     Background:~      - Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or~     postures. Musicians, writers, and athletes often get it. Researchers want to study how~     patients with this condition learn, a process of the brain that depends on a property called~     plasticity.~      Objective:~      - To study brain plasticity in people with FHD.~      Eligibility:~        -  Right-handed adults 18 years and older with FHD.~        -  Healthy, right-handed adult volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, pregnancy test, and~          questionnaire about their right-handedness.~        -  Participants will have 2 study visits on 2 different days.~        -  Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation~          (TMS) pulses on the left side of the head. A brief electrical current passes through a~          wire coil on the scalp. They will hear a click and may feel a pulling on the skin or~          muscle twitches. They may have to keep their eyes open and remain alert, tense certain~          muscles, or perform simple finger movements.~        -  Forty more pulses, with 10 seconds between, will be given on the left side of the head.~          Some will be small, some big.~        -  Researchers will measure muscle response through small electrodes taped to the right~          hand.~        -  A cloth cap will be put on the participant s head. Researchers will write on tape on~          the cap.~        -  Participants will have the r-PAS. An electrical stimulator will be placed on the nerve~          at the right wrist. Repeated magnetic pulses will be delivered in trains or short~          bursts together with electrical stimulation of nerve. Participants will receive up to~          840 pulses.~        -  Participants will be contacted after a few days for a follow-up check.~   "
72609|NCT02106923|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly~     developed fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and~     the single tablets of empagliflozin and metformin XR when administered singularly~   "
72610|NCT02106910|"~     Subjects presenting to UNC Hospitals for routine endoscopic surveillance examinations for~     current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of~     dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed~     consent, and the same day as the endoscopic procedure, the subject will undergo~     administration of the Cytosponge assay. The patient will then undergo routine endoscopic~     surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be~     placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge~     for processing according to their established protocols. Tissue biopsies will undergo~     standard processing and H&E staining, with assessment by expert gastrointestinal~     pathologists at UNC. The primary outcome variables will be sensitivity and specificity of~     the novel assay, compared against the gold standard of the presence of recurrent BE as~     detected by upper endoscopy with biopsies. Secondary outcomes include acceptability of the~     nonendoscopic assay to the patient (assessed by a standardized tool, the Impact of Events~     Scale, as well as a visual analogue scale), and likelihood of assay positivity as a function~     of amount of residual disease (as measured by Prague criteria).~   "
72611|NCT02106897|"~     The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either~     single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 in~     healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus~     Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and~     tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with~     SLE.~      Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of~     single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059~     in participants with SLE; To estimate the PK parameters and bioavailability (F) of a single~     SC dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059~     administered to healthy volunteers and participants with SLE. Secondary objectives of Part 3~     are as follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy~     volunteers and in participants with SLE; To evaluate the immunogenicity of BIIB059~     administered SC to healthy volunteers and participants with SLE.~   "
72612|NCT02106884|"~     This is a quality of life study done in the context of a randomized trial in pancreatic~     cancer. Patients with locally advanced or metastatic pancreatic adenocarcinoma receive~     either the combination of nab-paclitaxel gemcitabine or the existing standard gemcitabine~     alone treatment.The combination regimen of nab-paclitaxel and gemcitabine administered in~     patients with locally advanced or metastatic pancreatic cancer in a first line setting~     showed improved efficacy with acceptable toxicity. The current study design allows patients~     in standard treatment to receive the combination treatment at tumour progression.~      The proposed study will explore the impact of treatment on the quality of life and compare~     the times to definitive deterioration of the quality of life scores using the validated~     EORTC QLQ-C30. Efficacy and safety secondary endpoints are to be reported in a descriptive~     manner.~      Molecular studies will be performed on blood and tissue samples.~   "
72613|NCT02106871|"~     Investigation of the effects of daily sildenafil on patients with pancreatic or~     cholangiocarcinoma cancer undergoing treatment.~   "
72614|NCT02106858|"~     To investigate and collect post-marketing data on the safety of Stivarga in real world~     practice in its registered indication(s) as required by Health Authority.~   "
72615|NCT02106845|"~     Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate :~     P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by~     comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on~     Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients~   "
72616|NCT02106832|"~     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of~     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days~     every other 28 days or for 14 days every other 14 days over 48 weeks.~   "
72696|NCT02105792|"~     This study will examine extreme responders to second- and third-line Type 2 diabetes therapy~     using a prospective approach, and patients with slow or fast diabetes progression using a~     retrospective approach.~   "
72778|NCT02104726|"~     To compare relative efficacy of intraarticular steroid injection using anatomic landmarks~     vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the~     procedure.~   "
72617|NCT02106819|"~     The cerebellum has been linked to cognitive and emotional functions and there is increasing~     evidence that damage to posterior portions of the cerebellum can result in~     frontal-executive, visuospatial, and verbal deficits, including dysprosodia, and affective~     changes including blunting of affect or disinhibited and inappropriate behavior. Based on~     preliminary clinical observations and tests performed in the investigator's clinic,~     disorders of emotional communication may also be associated with cerebellar dysfunction.~     Emotional communication includes the production and comprehension of facial and prosodic~     expressions and is critical to maintaining positive and supportive relationships. Deficits~     in emotional communication can have devastating effects on relationships and on quality of~     life for those affected. Although deficits in affect and prosody have been reported in~     association with posterior cerebellar disorders, there are currently no studies~     systematically investigating emotional communication in individuals with cerebellar~     dysfunction. It is known that the cerebellum has strong connections with the cerebral~     cortex, especially the frontal lobes, and that cortical damage from stroke or~     neurodegenerative disease can result in disorders of emotional communication. Impairments in~     the integrity of cerebellar-cerebral networks from cerebellar disease may produce similar~     deficits in emotional communication. The purpose of this study is to systematically~     investigate and describe deficits in emotional communication in a series of patients with~     cerebellar disease. Participants will be individuals diagnosed with posterior cerebellar~     degeneration or damage from a non-hemorrhagic infarction, and age-matched neurologically~     healthy controls. Assessment will include a battery of tests of neuropsychological function~     as well as tests of emotional communication. Comprehension of emotional facial and prosodic~     expressions will be assessed as well as production of emotional communication. The expected~     outcomes will be to identify and describe deficits in production and comprehension of~     emotional prosodic and facial expressions and to describe the relationship between deficits~     in emotional communication and cerebellar atrophy with magnetic resonance imaging imaging~     (MRI) using voxel based morphometry (VBM).~   "
72618|NCT02106806|"~     Objective: To determine the oxidative stress during cycles of chemotherapy in patients after~     surgery for colorectal cancer, with or without oral zinc supplementation. Subjects: Twenty~     four adults from both genders participated in this study. All patients underwent stage II,~     III or IV colorectal cancer surgical resection and were starting chemotherapy in HCFMRP-~     USP. Patients were randomized into two groups. The first one (QTx-Zn Group, n=10) received~     70 mg/d of zinc orally and the second one received placebo (QTx-Placebo Group, n=14) for 16~     weeks. The study also included 30 healthy volunteers matched for age, gender and~     socioeconomic status, who received 70 mg/d of zinc supplement (Control-Zn Group, n=21) or~     placebo (Control-Placebo Group, n=9) for 16 weeks. Methods: The questionnaires about dietary~     intake (semiquantitative food frequency and food record), fatigue and quality of life~     (FACIT-F) and questionnaires that assess the side effects of chemotherapy (CTCAE) were~     evaluated. Anthropometry and bioelectrical impedance measurements were made. Blood~     collection was performed before the 1st, 2nd, 3rd and 4th cycles of chemotherapy (median~     duration of 21 days among cicles). Routine laboratory tests, vitamin E and markers anti and~     pro-oxidants (MDA, SOD, GPx and isoprostane) ere determined. The control group underwent the~     same procedures, except for chemotherapy. A longitudinal linear mixed effects model was~     adjusted for each of the variables of interest. The models were fitted using PROC MIXED of~     SAS version 9 (SAS, CARY, NC, USA). To analyze the association of categorical variables in~     the different items of the CTCAE, the investigators used the Fisher exact test. Results: The~     oral zinc supplementation was sufficient to increase plasma levels of zinc and did not alter~     food intake, body composition and routine laboratory evaluation of patients undergoing~     chemotherapy for colorectal cancer. Compared with QTx-Placebo Group, QTx-Zn Group showed~     lower prevalence of complaint on the salivary gland (17 vs. 75%). Fatigue (43 ± 6 vs. 36 ±~     13) and quality of life (126 ± 160 vs. 116 ± 27) has become worst in the period between the~     1st and 4th cycles of QTx in QTx-Placebo Group. When compared with QTx-Placebo Group, QTx-Zn~     Group had higher values of SOD before the 1st (2297 ± 503 vs. 1604 ± 352 USOD/g Hb), 2nd~     (2037 ± 515 vs. 1712 ± 417 USOD/g Hb) and 4th (2202 ± 323 vs. 1821 ± 360 USOD/g Hb) cycles~     of QTx. GPx values decreased in QTx-Zn Group before the 3rd cycle of QTx (48.5 ± 7.0 vs.~     54.3 ± 2.3 mol NADPH/min/gHb). Conclusions: These data suggest that zinc supplementation~     reduces complaints related to the change in salivary gland, preserving the quality of life~     and preventing the worsening of fatigue. The increase in SOD can be attributed to zinc~     supplementation per se, whereas this mineral is a cofactor that endogenous antioxidant~     enzyme. The highest activity of SOD increases the production of H2O2, whose detoxification~     involves the participation of GPx, justifying its reduction. There were no changes in plasma~     levels of vitamin E, MDA and isoprostane during the study period. Considering the values of~     MDA and isoprostane, the data indicate that regardless of zinc supplementation, the lipid~     peroxidation of the cell membrane was unchanged during chemotherapy.~   "
72619|NCT02106793|"~     Primary objective~        -  To compare the incidence of postoperative nasal synerchia between Mitomicin C and~          placebo in patients at 6 months after endoscopic sinus surgery~        -  To validate the Thai version of disease-specific quality of life tool SNOT-22~      Secondary objectives~        -  To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C~          with those who receive placebo~        -  To compare the disease-specific quality of life in patients who receive Mitomicin C~          with those who receive placebo~        -  To compare the side effects of Mitomicin C versus placebo~   "
72620|NCT02106780|"~     Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine~     and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites~     are collected until at least 144 hours after dosing.~   "
72621|NCT02106767|"~     The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin~     will be studied in clinical trial in White and Asian healthy volunteers.~   "
72622|NCT02106754|"~     This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide~     for Children and Adolescents. Of particular interest to the agency are evaluation of the~     Screener in clinical and/or other settings to predict alcohol-related consequences including~     use disorder; its use as an initial screen for drug use, cigarette smoking, conduct~     disorder, and unprotected sex; and its performance in making predictions concurrently and~     prospectively. This proposal targets these areas of interest. In addition, the investigators~     will study implementation of the Brief Intervention (BI) associated with the Screener. There~     is a great need for both screening and BI in juvenile probation settings as many of these~     youths have great need but are underserved.Many probation departments are turning to BI to~     work with probationers and parolees. Screening and BI has demonstrated efficacy in these~     settings, and yet no randomized control trials have been conducted to evaluate effectiveness~     in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener~     (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3~     conditions, and all receive usual services (US). US consist of regular check-in with PO and~     access to referral services as needed (counseling, academic tutoring, etc.). Research~     staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity,~     specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to~     predict alcohol risk and consequences, as well as other risky behaviors concurrently and~     prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine~     whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky~     sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching~     (an important consideration in implementation science) in use of BI improves outcomes. This~     study will be the first randomized controlled trial evaluating the effectiveness of SBI in a~     juvenile probation setting.~   "
72623|NCT02106741|"~     The purpose of this study is to compare two kinds of self-administered acupressure~     (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue~     and pain in low back pain patients.~      Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue~     and sleep quality, pain, and physical function compared to stimulating acupressure and usual~     care.~   "
72624|NCT02106728|"~     Eating Disorders are a debilitating and serious mental illness. This illness is associated~     with medical complications, psychological and social impairment. Families of people with an~     eating disorder also report that they lack resources and have many unmet needs. Families~     often have insufficient information regarding the eating disorder, available treatment~     options and strategies for supporting the person with the illness. The purpose of this study~     is to evaluate the effectiveness of two different family interventions for people with~     eating disorders and their family members (parents or partners) receiving treatment either~     in the inpatient or day treatment Eating Disorder Program at the Toronto General Hospital,~     University Health Network. Family supportive counseling consists of people with eating~     disorders and their family members meeting with a family therapist. Multi-family group~     therapy involves eight to ten families who meet as a group with two therapists. The~     investigators are conducting a study to assess the differences between these two different~     family interventions. This study will help us identify who benefits the most from~     participating in family supportive counseling or multi-family therapy. The investigators are~     also evaluating which intervention is more effective at helping the person with the eating~     disorder overcome their illness while helping their family members learn how to support the~     recovery process. Both family therapy interventions are delivered by experienced family~     therapy clinicians who work in either the Inpatient or Day Treatment Eating Disorder Program~     at Toronto General Hospital.~   "
72625|NCT02106715|"~     The purpose of this study is to investigate the prevalence of overload injuries to road~     cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise~     program for two months of training .~   "
72626|NCT02106702|"~     Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San~     Francisco jail. Two thirds of those released with HIV-focused discharge planning are~     reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed~     with mental health conditions severe enough to require medication and a similar proportion~     report substance use disorders at the time of detention. While some community-based services~     exist, there remains a critical need to improve linkages to care and adherence to care plans~     for HIV-infected adults as they move between community and jail. The Navigator Project is a~     five-year randomized study that will test the effectiveness of an intensive enhanced case~     management intervention to reduce sex and drug-related HIV transmission risk; increase HIV~     medication adherence; reduce drug dependence; and reduce reincarceration.~   "
72627|NCT02106689|"~     The daily injections required for superovulation, a fertility treatment using injections to~     stimulate a women's ovaries to produce multiple eggs, can be an anxiety provoking process~     for many women and a deterrent to treatment. Alternative needle-free injection systems have~     been developed with the intention of reducing needle phobia and pain, while providing~     similar results. However, these needle-free systems are not yet being widely used for women~     with infertility.~      The purpose of this study is to assess whether the pain and apprehension patients often~     associate with needles and injections, can be alleviated by using a new, Health Canada~     approved, needle-free system. The purpose of the current study is to assess whether patient~     satisfaction is improved in patients using a needle free injection system for the daily self~     injections required for superovulation induction as compared to patients using the standard~     needle and syringe.~   "
72628|NCT02106676|"~     The aim of this study is to determine maternal androgen metabolism during pregnancy and the~     impact of androgen disorders on mothers and infants.~   "
72629|NCT02106663|"~     This is a PI-initiated study that aims to evaluate the efficacy of two different methods of~     paroxysmal atrial fibrillation (PAF) ablation. There are currently two strategies for PAF~     ablation that are routinely performed by electrophysiology clinicians: (1) circumferential~     pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). However,~     it is not known if one approach is better than the other. This randomized study will~     evaluate and compare the efficacy of CPVA versus SPVI in subjects undergoing ablation for~     paroxysmal atrial fibrillation only. Subjects will have a 50/50 chance of receiving either~     the CPVA or SPVI ablation method.~   "
72630|NCT02106650|"~     This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related~     Grade 3 or higher oral mucositis.~   "
72631|NCT02106637|"~     The hypothesis of this study is that combination of Varenicline treatment with nurse-led~     hospital support during hospitalization and after discharge will result in clinically~     significant higher long term abstinence rates in smokers with ACS, as compared with nurse~     led support and placebo, without a significant increase in the risk of adverse events.~   "
72632|NCT02106624|"~     The patients with sepsis are in high risk of malnutrition, which could contribute to~     infection, difficulty in weaning from ventilators. The investigators speculate whether~     nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the~     outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the~     investigators aim to compare high nitrogen intake with conventional nitrogen supply which~     were recommended in guidelines.~   "
72633|NCT02106611|"~     This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma~     associated heart disease compared to a stress echocardiogram. By doing both stress~     echocardiography and cardiac MRI, we will compare the ability of the two tests to detect~     heart disease.~   "
72634|NCT02106598|"~     Current imaging devices usually detect cancer prior to surgery. However, these devices~     cannot be used during the surgical procedure to visualize lymph nodes with cancer (called~     sentinel lymph nodes). The groups are for head and neck melanoma, gynecologic, and breast~     cancers. As a part of the standard of care, the they will initially undergo imaging of their~     lymph nodes prior to their surgery. Melanoma and breast cancer patients will be injected~     with a radioactive dye around the tumor site, and images will be acquired about 2 hours the~     location of the later using a device to image the dye. For gynecologic cancer patients, they~     will be injected with a indocyanine green in the operating room and then images will be~     acquired soon after. In addition, the investigators will test, for the first time in humans,~     a new, experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node~     mapping. This particle, the size of a small protein, will be injected around sites of~     melanoma before or during your surgery to identify diseased nodes using a hand-held camera~     system. The dye-labeled particle can be viewed in tissues that may contain tumor. Based upon~     the clinical diagnosis, the patient may have a procedure called Reverse Lymphatic Mapping,~     which is a new form of sentinel lymph node mapping. The doctor will discuss this with the~     patient. If the patient is undergoing reverse lymphatic mapping, they will have the~     experimental particle injected into their hand or foot (based on their tumor type) and the~     standard of care injection will be injected around the tumor. This will allow the surgeon to~     remove only the lymph nodes that directly link to the tumor. The particles will not treat~     the cancer and any images or information found during this study will not be used for your~     treatment. The information collected may be used to guide the design of future studies to~     detect and/or treat tumors.~   "
72635|NCT02106585|"~     The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics)~     of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to~     evaluate the effect of food on the PK of JTT-251 in healthy subjects.~   "
72636|NCT02106572|"~     The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with~     Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation~     of the time to tumor recurrence. Secondary objective is to evaluate the safety of~     abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another~     secondary objective is the treatment efficacy as measured by calculated prognosis for~     recurrence and progression after 1 year, the tumor grading in case of a recurrence and by~     measurement of Quality of Life.~   "
72637|NCT02106559|"~     This pilot clinical trial studies photodynamic therapy during surgery in treating patients~     with pleural (the protective lining or membrane that covers the lungs and chest cavity)~     malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer~     (a substance that makes cells more sensitive to light), such as porfimer sodium, together~     with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply.~     Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain~     after surgery.~   "
72638|NCT02106546|"~     This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of~     veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin~     and paclitaxel in subjects with advanced or metastatic squamous NSCLC.~   "
72639|NCT02106533|"~     The purpose of the present study was to test the hypothesis that patients with coronary~     artery disease with lower aerobic fitness exhibit greater responsiveness on improving~     ventilatory efficiency after aerobic exercise training.~   "
72697|NCT02105779|"~     The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive~     remediation in schizophrenia in order to maximize treatment response. The investigators will~     investigate factors that have generally been ignored in prior computer-based cognitive~     remediation programs—those related to social cognition-- and will delineate their~     relationship to motivation, functional outcome, and the neural substrates of reward~     anticipation and emotion processing. Current research indicates that, unless the~     investigators fully understand and harness these factors, the investigators will not achieve~     meaningful treatment gains for individuals with schizophrenia.~   "
72640|NCT02106520|"~     Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (~ 1/6000) but ubiquitous genetic~     disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance,~     leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are~     concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both~     diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.~      Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.~      The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on~     the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab~     administered as a nasal spray in a repeated manner (3 administrations) in patients with~     Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.~      This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be~     carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for~     second step~   "
72641|NCT02106507|"~     The purpose of this study is to test the safety of the combination of apalutamide plus~     everolimus at different dose levels.~   "
72642|NCT02106494|"~     The primary study objective is to demonstrate the superiority of APF530 500 mg given~     subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a~     maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined~     as no emesis and no use of rescue medications) in subjects receiving highly emetogenic~     chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines~   "
72643|NCT02106481|"~     The purpose of this study is to compare two methods of pain control used during total knee~     joint replacement surgery. The pain medication that will be used for this study is not~     experimental.~      The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve~     Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives~     patients better pain control, increasing the capability to participate in physical therapy~     and decreasing the consumption of other pain medication. With either the single shot or the~     catheter the local numbing medication called ropivacaine will be used.~   "
72644|NCT02106468|"~     This study was initiated to evaluate the potential of dietary supplementation of omega-3 for~     providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive~     lichen planus.~   "
72645|NCT02106455|"~     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate~     tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients~     with osseous Paget's disease for 48 weeks from baseline in daily medical practice.~   "
72646|NCT02106442|"~     The purpose of this study is to evaluate the efficacy (endpoints: frequency of bone~     fractures, percent change in bone density, etc.) and safety of administration of sodium~     risedronate tablets (Benet 75 mg Tablets) for 36 months in osteoporosis patients in daily~     medical practice.~   "
72647|NCT02106429|"~     Pathological and clinical studies have consistently demonstrated that abnormalities in~     thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and~     atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring~     platelet activity, thrombin generation, and markers of coagulation have been proposed to~     identify individuals at high-risk for cardiovascular events, however, it remains a research~     tool not ready for implementation in standard care.~      The proposed study will add to the growing understanding of platelet activity and markers of~     coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity~     markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in~     subjects undergoing vascular surgery; and will provide important data on the mechanism of~     increased platelet activity using micro RNA, RNA and DNA expression profiling. The study~     design is prospective and the main outcome measures are platelet activity, coagulation~     markers and incident cardiovascular and bleeding events.~   "
72648|NCT02106416|"~     The purpose of this study is to develop a novel technique for integrated PET/MRI tracer~     kinetic analysis for urologic malignancy.~   "
72649|NCT02106403|"~     The objective of this randomised, examiner and subject blinded study is to evaluate and~     compare cooling performance and overall consumer liking of the prototype formulation with~     the currently marketed wound spray and negative control in subjects with experimental~     wounds. For each subject, three superficial wounds will be induced on two volar forearms, by~     sequential tape strippings until a glistening layer is visualized. After wounding, a~     randomised test product will be sprayed twice on test site, and the subject will be asked to~     complete a questionnaire evaluating product cooling performance and overall liking.~   "
72650|NCT02106390|"~     The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability~     of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at~     3, 5, 7 and 13 months of age, compared to either alone.~   "
72651|NCT02106377|"~     Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse~     therapy, administered twice daily (to avoid adverse effects associated with long-term~     steroid use). This timeframe is often too short to meaningfully resolve the inflammation~     associated with DED. Thus, corneal specialists, including here at MEEI, have begun using~     steroid treatment of at least 6 weeks with tapered dosing.~      In vivo confocal microscopy (IVCM) is a novel imaging technology that allows the~     visualization and quantification of certain corneal features associated with DED, such as~     hyperfluorescent superficial epithelial cells, immune dendritic cells, and sub-basal nerves.~     Recent cross-sectional studies have begun to shed light on the correlation of these features~     with traditional outcome measures typically assessed in DED, such as corneal and~     conjunctival staining, Schirmer's testing, tear break-up time (TBUT), and symptom~     questionnaires. However, longitudinal studies using IVCM to demonstrate how steroid~     treatment affects the corneal epithelial cells, dendritic cells and nerves are largely~     lacking. Furthermore, studies on the safety and efficacy of a 6 week tapered dosing steroid~     regimen are also lacking.~   "
72652|NCT02106364|"~     The main purpose of this study is to compare the efficacy and safety of a new basal insulin,~     insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM).~     Both drugs will be given by an injection under the skin. Participants may continue to take~     oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal~     physician. The study is expected to last about 12 months for each participant.~   "
72655|NCT02106325|"~     Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment~     for people with Major Depressive Disorder. This study plans to explore the potential that~     Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting~     to the Emergency Department with severe depression. since this is a controlled trial we will~     use an IV of Ketamine or and equivalent volume of Diphenhydramine. Sixty subjects will be~     randomly assigned to receive Ketamine (30 participants) or Benadryl(30 participants).~     Investigators will then compare measures of mood pre- and post-infusion in the Emergency~     Department. to supplement self-reported measures of depressive symptoms(e.g. mood),~     investigators will obtain objective measures of the biological aspects of Major Depressive~     Disorder. With the current evidence pertaining to our hypothesis, investigators hope to add~     to the growing scientific studies surrounding such a vulnerable population.~   "
72656|NCT02106312|"~     To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid~     Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological~     responses.~   "
72657|NCT02106299|"~     To evaluate the treatment safety and efficacy of Regen Sling developed by medprin~     Regenerative Medical Technologies Co., Ltd. for female patients with stress urinary~     incontinence~   "
72658|NCT02106286|"~     A major determinant of perioperative mortality is the inability of the heart to increase its~     output in response to surgical stress. This is termed perioperative cardiac failure (PCF),~     and may only be apparent postoperatively when oxygen demand is increased. The risk of~     perioperative cardiac complications is the summation of the individual patient's risk and~     cardiac stress related to the surgical procedure1. The functional capacity of the patient~     determines their ability to support the postoperative demand of increased oxygen~     consumption, and therefore of cardiac output. Exercise capacity is one of the most powerful~     predictors of cardiovascular and all cause mortality2. Cardiopulmonary exercise test (CPET)~     is an established investigation used, among other applications, in the preoperative~     assessment of patient fitness for surgery3. CPET involves monitoring the~     electrocardiographic trace and the exhaled gas mixture (particularly CO2, whose production~     depends on aerobic metabolism), during incremental exercise (usually on an exercise bike),~     on room air. Several parameters can be measured during CPET, including maximal systemic~     oxygen delivery, the anaerobic threshold (the oxygen delivery value at which anaerobic~     metabolism begins), maximum workload, and ST segment depression/elevation (as in a standard~     exercise tolerance test). The cardiopulmonary performance during CPET has been correlated~     with postoperative outcome3. Pulmonary function tests will be performed in order to assess~     lung function.~      It is well known that therapy with beta-blockers in patients with ischaemic heart disease~     and cardiac failure reduces perioperative morbidity and mortality4-7. However, beta blockers~     reduce myocardial contractility and the heart rate response to adrenergic stimulation, thus~     blunting the physiological response to stress/surgery/exercise. Whilst this mechanism may~     protect the heart perioperatively, it may decrease the ability of some patients to withstand~     other complications. This potential decrease in performance has never been quantified.~      There is no agreement on whether preoperative CPET should be performed on or off~     beta-blockers and, at Aintree in particular, it is standard procedure to take patients off~     beta-blockers prior to their CPET. Some argue that, as beta-blockade should be maintained in~     the perioperative period, CPET should be performed on medications, even if these could mask~     the presence significant ischaemic heart disease (a significant, modifiable, risk factor for~     surgery by beta blockade), and even if it is not always possible to maintain beta-blockade~     throughout the whole postoperative period. For these reasons, other clinicians prefer to~     perform CPET off beta-blockers, thus, potentially, overestimating the perioperative~     cardiorespiratory performance, which may be diminished once the medications are resumed.~     Patients on long-term beta blockade may develop some tolerance to the medications, so the~     effect of acute and chronic beta blockade on cardiorespiratory performance may also be~     different.~      Aim To compare cardiopulmonary performances on and off beta blockers as objectively assessed~     by cardiopulmonary exercise testing.~   "
72659|NCT02106273|"~     An observational pilot study to determine the success rate of using LMA Proseal in~     conjuction with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.~   "
72660|NCT02106260|"~     This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to~     assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of~     topically applied CLS003 in healthy subjects with cutaneous warts.~   "
72661|NCT02106247|"~     To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to~     evaluate pharmacokinetics, safety and tolerability following single oral doses of BI~     1181181.~   "
72662|NCT02106234|"~     Contrast-induced nephropathy (CIN) is a side-effect of intravascular administration of~     iodinated contrast material. It is defined as an absolute (>44μmol/l) or relative (>25%)~     increase in serum creatinine from baseline values within 48-72 hours of iodinated contrast~     material administration, and usually resolves within two weeks. In some cases CIN has been~     associated with persistent renal failure, increased risk of dialysis, and mortality. It is~     not clear however, whether CIN is causally related to this increased risk or whether risk of~     morbidity and mortality is inherent in those at risk of CIN.~      CIN itself is asymptomatic and no treatment for CIN exists. Therefore, the focus lies on its~     prevention. Prevention guidelines have been drawn up in most countries and been implemented~     in most radiological departments. In the Netherlands, currently two guidelines for the~     prevention of CIN coexist, issued by CBO (Centraal BegeleidingsOrgaan) and VMS (Veiligheids~     Management Systeem).~      The prevention guidelines aim to increase patient safety by identifying patients that may be~     at risk of CIN (mostly patients with chronic renal insufficiency), and subsequently~     administering prophylactic intravenous hydration to the so identified patients, in order to~     prevent CIN (intravenous normal saline 4-12 hours before and 4-12 hours after exposure to~     iodinated contrast material).~      Needless to say, the introduction of these guidelines has had a great impact on patient- and~     health care burden. In the Netherlands alone it is estimated that yearly 100.000 to 150.000~     patients receive the prophylactic treatment, incurring a total cost of over 50 million Euro.~     Considering the steady yearly increase of contrast procedures and the ageing population, it~     is evident that, in future, these numbers shall only increase further.~      The prophylactic treatment prescribed by the guidelines is based on a consensus of the~     opinion of experts in general agreement that the treatment is beneficial. However, the~     effectiveness of prophylactic hydration has never been adequately evaluated. Sufficiently~     large randomised trials comparing prophylactic intravenous hydration with a proper control~     group receiving no prophylactic treatment are not available, and baseline CIN incidences in~     untreated populations are unknown. Thus, it is not clear whether prophylactic hydration~     achieves its aim to prevent CIN.~      In order to be able to take effective measures to the benefit of patient safety, it is~     important to distinguish between the mechanisms underlying CIN and the ensuing increased~     risk of morbidity and mortality: whether it be biological variation of serum creatinine,~     renal damage, or cholesterol embolism; whether any causality exists between these and~     iodinated contrast material; and whether prophylactic intravenous hydration can prevent~     these from occurring without incurring more risks than it removes. These, in short, are the~     aims of the AMACING study.~   "
72663|NCT02106221|"~     The purpose of this study is to support enhancement, implementation, and evaluation of an~     improved model for delivering improved primary care to high-risk older adults through the~     use of health IT tools, focusing on issues related to the patient-centered primary care home~     (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes.~     During this study, participating clinics will utilize the already-implemented Integrated~     Care Coordination Information System (ICCIS). Clinic staff will meet with a practice~     facilitator (monthly and as needed), and will track study activities and submit invoices via~     ICCIS reporting. These invoices will be used to simulate a shared savings model where~     clinics will be reimbursed based on their progress and effort towards their goals.~      Clinics will set and work towards goals that they have chosen. Goals for the control arm are~     self-selected by the clinics themselves; goals for the invention arm are related to~     high-value elements (HVE) that have been identified as areas that can improve patient~     outcomes. These HVE are:~        1. Evidence-based Care Management Based on Need~        2. Identification of At-Risk Populations~        3. Patient Engagement and Alerts Based on Goals~        4. Integrated Information for Care Management, especially around Utilization~        5. Population Management Tools~   "
72664|NCT02106208|"~     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese~     consumption, with potentially important impact on this key industry in Canada. This is in~     part due to the commonly accepted notion that saturated fat in the diet, of which cheese~     contributes significantly, increases the risk of heart disease. Yet, a rather large body of~     recent evidence suggests that saturated fat may have been unfairly demonized and that its~     impact on the risk of heart disease may in fact be less important than originally thought.~     This concept that dairy fat increases the risk of heart attacks therefore needs to be~     revisited, and this is one of the key objectives of this proposed research program.~      The proposed research is designed to investigate for the first time if dairy fat improves~     the levels of the so-called good cholesterol, a protective risk factor that has been~     essentially ignored in the arguments supporting the reduction of saturated fat for heart~     health.~      Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet~     and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations~     and functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL~     particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and~     apolipoproteins B (apoB) concentrations compared with a low fat diet.~   "
72665|NCT02106195|"~     The primary objective is to assess the safety and tolerability of 200 mg of KD025~     administered orally once daily for 28 days~   "
72666|NCT02106182|"~     The objective of this study is to determine safety and efficacy of silodosin, which is a~     treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on~     patients with benign prostatic hyperplasia accompanied by nocturia.~   "
72667|NCT02106169|"~     The purpose of the study is to determine whether therapeutic education can improve the~     quality of life of the child from 8 to 12 years old suffering of food allergy.~      This study also show us if therapeutic education has an effect on the quality of life of~     child's family.~   "
72668|NCT02106156|"~     This observational study will examine the efficacy and safety of pegylated interferon~     (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis~     C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated~     CHC patient population in Germany is expected to be studied over a period of 5 years.~   "
72669|NCT02106143|"~     Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System~     radial spray cryotherapy is a novel procedure being developed as a treatment for conditions~     associated with abnormal bronchial function, such as chronic bronchitis. The development of~     appropriate reliable equipment, definition of therapeutic parameters, and an understanding~     of the tissue effects of treatment have been established through animal studies. This~     clinical study is being undertaken to assess the feasibility and safety of the application~     of a radial metered dose spray cryotherapy in the human airway and to evaluate the treatment~     depth in human airways. The study design is prospective, open label, single arm multi-center~     study that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and~     The Netherlands RejuvenAir System treatment will be performed during preoperative~     bronchoscopy 0 to 60 days prior to prescheduled lung resection in Subjects requiring~     lobectomy or pneumonectomy for removal of peripheral tumors. Treatment will be limited to~     areas of the bronchi within the lobe that will be removed, distal to the anticipated margin~     of resection. Treatment should be at least 1 cm from the bronchial resection margins and~     away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of~     thoracotomy, and examined histologically following surgical resection. Subject participation~     will be from 1 to 60 days and enrollment is anticipated to take 4-5 months.Total study~     duration is expected to last approximately 10 months.~   "
72670|NCT02106130|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive~     Mosapride citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.~   "
72671|NCT02106117|"~     Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely~     dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is~     still a critical problem. Symptoms are non-specific and available diagnostic tools are~     either invasive or have low sensitivity and specificity. This often results in a diagnostic~     delay, with patients developing more extensive disease. Furthermore, as long as IA is~     present, oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can~     cause serious treatment delay and increased mortality. However, an empirical strategy with~     prophylactic anti-mould therapy is not feasible considering both possible side effects and~     costs. In order to safely continue the use of a pre-empirical strategy, improved~     (non-invasive) diagnostic tools are desirable.~      In a pilot study de Heer et al. showed that it is possible to discriminate between patients~     with IA and their neutropenic controls by exhaled breath analysis using an electronic nose~     (eNose). In this study the investigators aim to test whether an eNose could be useful as a~     diagnostic tool in a prospective setting.~      The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry~     (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in~     breath of patients. It is possible that there are Aspergillus specific VOCs in the breath of~     patients with IA.~      The composition of the lung microbiome seems to be an important factor in both health and~     disease. It is likely that the microbiome of the lung changes in prolonged neutropenia,~     therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of~     patients with prolonged neutropenia who develop IA with those who do not, can learn us more~     about the pathogenesis of this disease. This knowledge could be used to investigate new~     treatment options for Invasive Aspergillosis.~      Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence~     and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to~     treatment of hematological malignancies, are different between patients who develop IA and~     patients who do not.~   "
72672|NCT02106104|"~     The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4~     inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.~   "
72673|NCT02106091|"~     The purpose of this study is to determine whether AFM11 is safe and active in the treatment~     of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL).~   "
72674|NCT02106078|"~     The investigators hope to learn whether access to online support and education can help~     people with Bipolar Disorder (BD) better manage their symptoms of depression.~   "
72675|NCT02106065|"~     The purpose of this study is to study the effects of an education and skill-building~     intervention on family caregivers of Veterans with dementia.~   "
72706|NCT02105662|"~     The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100~     mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C~     virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The~     primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir~     and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater~     than 70%.~   "
72676|NCT02106052|"~     Cognitive impairment affects roughly 50% of people with multiple sclerosis (MS). There are~     currently no satisfactory medical treatments for cognitive impairments related to MS and~     alternative forms of treatment are needed. Exercise training can improve cognition in older~     adults and people with mild cognitive impairments, including those with early Alzheimer's~     disease. Therefore, the investigators plan to conduct the first definitive study that will~     test the theory that moderately intense aerobic exercise can improve cognition in people~     with MS-related impairment - specifically in information processing speed - more so than~     non-aerobic stretching and toning (both forms of exercise will be performed 3 days per week~     for 6 months).~      Primary study hypothesis: The investigators hypothesize greater improvement in speed of~     information processing from pre- to post-treatment in the aerobic exercise group compared to~     the stretching and toning group (attention control).~      Secondary study hypothesis: The investigators hypothesize greater improvement in other~     cognitive domains and patient reported outcomes from pre- to post-testing in the aerobic~     exercise group compared to the stretching and toning group (attention control).~      The investigators plan to recruit 125 adults with MS who can walk without assistance and~     without rest for at least 100 meters and have mild weaknesses in information processing~     speed. The investigators will randomly assign 50% of participants to an aerobic exercise~     program and 50% to a non-aerobic exercise program (stretching and toning). In order to~     determine whether the intervention is successful, the investigators will compare cognitive~     functioning in both exercise groups before the exercise-training program, at the end of the~     6-month training program and three months after the end of the training program. If our~     study findings support our hypotheses, this would be a relatively no-barriers treatment~     option to further explore for other people with MS including people with greater and lesser~     baseline disability.~   "
72677|NCT02106039|"~     The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of~     diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis-~     diabetes patients.~   "
72678|NCT02106026|"~     An antenatal education intervention in primiparous women improves breastfeeding duration and~     reduces post-natal complications.~   "
72679|NCT02106013|"~     This is a study of HDL function in healthy individuals classified in three groups according~     to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the~     purpose of investigating which characteristics of the HDL particle might be associated to~     atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.~   "
72680|NCT02106000|"~     The purpose of this study is to record and compare the inhalation profiles of non pregnant~     women and those who are in the third stage of labour. The inhalation profiles will be~     recorded from consenting women as they inhale with maximal effort through an inhalation~     profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to~     airflow and will be representative of a dry powder inhaler of moderate resistivity. The~     inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled~     Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be~     compared between the two female cohorts. Inhalation profiles recorded in this way may~     subsequently be used to study the in-vitro performance of investigational materials across~     inhalation parameters representative of the target patient population.~      An appropriate number of subjects will be consented so that approximately 40 subjects (20~     non-pregnant females and 20 stage three labour subjects) complete assessments. The~     inhalation profiles will be recorded on the same day of screening or at another time within~     a span of 50 days~   "
72681|NCT02105987|"~     This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled,~     multicenter, parallel group, non-inferiority study. This study is designed to demonstrate~     the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams~     (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared~     with continuing the subject's current suppressive regimen through 24 weeks. The study will~     be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected~     individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2~     Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI),~     an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI).~     Eligible subjects will be randomly assigned 1:1 to continue their current regimen~     (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects)~     once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue~     their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24~     weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that~     treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted~     at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well~     as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and~     tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir~     (FPV/r) or tipranavir/ritonavir (TPV/r).~   "
72682|NCT02105974|"~     This is a Phase IIIa, multicenter, randomized, stratified (reversibility status),~     double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25~     micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via~     the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on~     lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF~     100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD~     and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD.~     ELLIPTA™ is a registered trademark of GlaxoSmithKline.~   "
72683|NCT02105961|"~     This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group,~     trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through~     subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated~     to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction~     of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD~     exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects~     who are at or above the baseline blood eosinophil count of at least 150 cells/microliters~     who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD~     subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized~     in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC.~     The total duration of subject participation will be approximately 62 weeks, consisting of a~     1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.~   "
72707|NCT02105649|"~     It will be hypothesized that strengthening the calf muscles will improve standing efficiency~     in children with spastic diplegia.~   "
72708|NCT02105636|"~     The purpose of this study is to find out whether Nivolumab will significantly improve~     overall survival as compared to therapy of investigator's choice in patients with recurrent~     or metastatic head and neck carcinoma.~   "
74084|NCT02087657|"~     By doing this study, researchers hope to learn the following:~        -  The safety of hyperbaric oxygen administration in the setting of the autologous~          transplant~        -  The effects of hyperbaric oxygen administration on neutrophil count recovery and~          engraftment~   "
72684|NCT02105948|"~     This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial~     evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC)~     injection.~      In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in~     severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in~     COPD patients would translate into a reduction of COPD exacerbations. The study will~     determine the reduction in exacerbations in subjects who are above and below the baseline~     blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the~     efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in~     COPD subjects at high risk of exacerbations, despite the use of optimized standard of care~     background therapy.~      Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive~     placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this~     study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week~     treatment period and 8-week follow-up period.~   "
72685|NCT02105935|"~     This study's objectives are:~        -  To prospectively examine changes in brain network activation (BNA™) from baseline to~          recovery (i.e., return to activity) in youth and adolescent athletes with concussion.~        -  To assess the clinical utility of changes in BNA to assist in clinical decision-making.~        -  To generate normative BNA data.~   "
72686|NCT02105922|"~     From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:~      HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity~     Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily.~      15 subjects from each group will be recruited and tested after 3 months of intervention.~     Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size,~     cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c.~     Tests are to be compared with Project ID NCT01997320.~   "
72687|NCT02105909|"~     This is a GWAS pilot study that aims to identified possible candidate genes associate to~     obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese ,~     metabolically healthy white adults, matched with lean, white adults , metabolically healthy.~     The investigators hypothesize that the careful phenotyping of the subject sand matching with~     increase the power to find SNP significantly associate with obesity (as defined by BMI).~   "
72688|NCT02105896|"~     Purpose: To evaluate the performance of several dental adhesives used for bonding~     tooth-colored fillings to teeth 6 years after the fillings have been placed.~      Participants: Subjects which had participated in the study entitled Clinical Evaluation of~     New Total-Etch and Self-Etch Dental Adhesives (IRB Study #07-0673).~      Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a~     direct, visual examination. Close-up intra-oral clinical photographs of each filling will be~     made. An impression of the filling may be obtained.~      The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673~     is to evaluate the fillings placed according to the following characteristics: Retention;~     Color match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal~     adaptation and/or integrity; Post-operative sensitivity.~   "
72689|NCT02105883|"~     The purpose of this study is to evaluate if the use of identification badge (role and place)~     during high-fidelity simulation as an impact on situation awareness.~   "
72690|NCT02105870|"~     Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients~     suffering an acute myocardial infarction.~      The investigators hypothesise that treatment with intracoronary abciximab, a potent anti~     platelet agent, at the time of coronary stent insertion, will improve microvascular~     function.~   "
72691|NCT02105857|"~     The purpose of the study is to find the best way to mobilize a knee after total knee~     arthroplasty (TKA). In particular, the aim of this study will be to investigate the~     advantages of adding a gentle knee mobilization to the standard rehabilitation used by~     physiotherapists in this hospital after TKA.~      All individuals waiting for TKA from the Departement de l'appareill Locomoteur (DAL) -~     Centre Hospitalier Universitaire Vaudoise (CHUV) will be considered for this research~     trial. The number of individuals necessary to complete this study is 32.~      Participants deciding to take part will be given an information sheet and asked to sign a~     consent form. If deciding to take part, they will still be free to withdraw at any time and~     without giving a reason. A decision to withdraw at any time, or a decision not to take part,~     will not affect the standard of care they receive.~      People who agree to take part will be randomly selected into 2 groups: one group will follow~     the standard treatment used in physiotherapy after TKA, the other group will have the same~     treatment and the technique of A+ mobilization in investigation added. Participants have 50%~     chances to be allocated to either of the groups. Before surgery, at the first and seventh~     day after operation, the researchers will measure the range of motion (ROM) of the replaced~     knee. This means that the study will last till the moment the last participant leaves the~     DAL - CHUV, which is estimated to be in 12 months after the first recruitment.~      Individuals over 18 years old undergoing unilateral primary TKA caused by osteoarthritis~     will included. Exclusion criteria will be: a) insufficient French language skills to agree a~     written consent, b) body mass index (BMI) >40 kg/m2, c) symptomatic OA in the contralateral~     knee (defined as self-reported knee pain >4 on a 10-point verbal analogue scale), d) other~     lower extremity orthopedic problems limiting function, e) neurologic impairment or g)~     cognitive dysfunction.~      No life-style restrictions will be requested. Patients will just need to follow the~     physiotherapist's usual advices during the in-hospital period at the DAL - CHUV. This study~     does not alter the standard procedures, patients will receive all the techniques used in~     physiotherapy as every other TKA patient. If allocated into the mobilization group, a~     specific knee splint will be positioned on the patient's knee. This position will be held~     for 20 minutes with the leg straight and 20 minutes bent, twice a day. The person in charge~     of these procedures is the principal investigator of the study, a certified orthopedic~     physiotherapist on the staff of the DAL - CHUV. No additional changes to patients' daily~     routine will be involved.~      To the investigators knowledge, there are no side effects due to use of this mobilization.~     Nevertheless, the pain levels of every patient will be recorded to identify any differences~     between groups. If, during or after the clinical study, any patient will face unexpected~     health problems related with the study, they will be kindly asked to transmit the~     information to the principal investigator of the study. The mobilization technique involves~     no additional risk over that of standard treatment performed in the hospital. This study~     hypothesis that adding A+ graded mobilization combined with the standard in-hospital~     rehabilitation protocol will improve ROM without increasing pain.~      All information collected will be kept strictly confidential. Any information used will have~     names and addresses removed. All data will be stored, analyzed and reported in compliance~     with the Data Protection Legislation of Switzerland.~   "
72692|NCT02105844|"~     Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall,~     2600 patients with documented atrial fibrillation aged >65 years will be included and~     followed on a yearly basis.~      Yearly clinical examinations include a detailed questionnaire on personal characteristics, a~     resting electrocardiogram, neurocognitive function tests and questionnaires on disability~     and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at~     baseline and after 2 years of follow-up.~      The main study aims of this long term prospective study are to increase our knowledge on~     structural brain damage and its changes over time in patients with atrial fibrillation, to~     gain additional insights on the incidence and underlying mechanisms of cognitive decline in~     patients with atrial fibrillation and to evaluate the interrelationships of structural and~     functional brain damage in this population.~   "
72693|NCT02105831|"~     Advanced heart failure (when the heart pump fails) is associated with symptoms such as~     shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of~     the pump, however abnormal regulation of blood flow to the muscles of the body is also a~     potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate~     for patients with failing hearts either as a bridge to heart transplant or as long term~     therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in~     the improvement of symptoms is unknown. Understanding how skeletal muscle and heart~     perfusion is altered in heart failure patients before and after implantation of an LVAD~     could provide further insight into the beneficial effects of this therapy.~      Specific Aims:~        1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD~          implantation~        2. To compare functional status with degree of skeletal muscle perfusion.~   "
72694|NCT02105818|"~     The purpose of this study is the validation of a newly developed self-report questionnaire~     which aims at determining the prevalence, location and intensity of SWAllowing difficulties~     with drug intake, and describing the impact on MEdication regimen focusing on COping~     strategies (SWAMECO).~   "
72695|NCT02105805|"~     30 obese moderate-to-severe heart failure patients will be randomized to intervention or~     control in groups of 5-10 subjects.~      All will receive dietetic advice according to randomization and according to the European~     Heart Association.~      Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula~     diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d~     substituting two daily meals with formula meal replacement.~      Control subjects are advised to follow the Nordic Nutrition Recommendations.~      Patients will be monitored by blood sampling and assessed by change in physical performance.~   "
72698|NCT02105766|"~     Background:~      - Some sickle cell disease or beta-thalassemia can be cured with transplant. Researchers~     want to test a variation of transplant that uses low dose radiation and a combination of~     immunosuppressive drugs. They want to know if it helps a body to better accept donor stem~     cells.~      Objectives:~      - To see if low dose radiation (300 rads), oral cyclophosphamide, pentostatin, and sirolimus~     help a body to better accept donor stem cells.~      Eligibility:~      - People 16 and older with beta-thalassemia or sickle cell disease that can be cured with~     transplant, and their donors.~      Design:~        -  Participants and donors will be screened with medical history, physical exam, blood~          test, tissue and blood typing, and bone marrow sampling. They will visit a social~          worker.~        -  Donors:~        -  may receive an intravenous (IV) tube in their groin vein.~        -  will receive a drug injection daily for 5 or 6 days to move the blood stem cells from~          the bone marrow into general blood circulation.~        -  will undergo apheresis: an IV is put into a vein in each arm. Blood is taken from one~          arm, a machine removes the white blood cells that contain blood stem cells, and the~          rest is returned through the other arm.~        -  Participants:~        -  may undergo red cell exchange procedure.~        -  will remain in the hospital for about 30 days.~        -  will receive a large IV line that can stay in their body from transplant through~          recovery.~        -  will receive a dose of radiation, and transplant related drugs by mouth or IV.~        -  will receive blood stem cells over 8 hours by IV.~        -  will take neuropsychological tests and may complete questionnaires throughout the~          transplant process.~        -  must stay near NIH for 4 months. They will visit the outpatient clinic weekly.~        -  will have 5 follow-up visits for 3 years after transplant, then annually.~   "
72699|NCT02105753|"~     Primary axillary hyperhidrosis is a common idiopathic disorder of the eccrine sweat glands~     that interferes with daily activities and causes significant social distress. This pilot~     study is designed to evaluate the efficacy and histologic effects of the 1210nm diode laser~     for the treatment of axillary hyperhidrosis. Initial results may inform the design of an~     anticipated larger prospective controlled trial. Study participants will receive one laser~     treatment to one randomly-assigned axilla using the 1210 nm diode laser, and two treatments~     to the opposite axilla. Changes in sweating will be measured both by quantitative~     gravimetric analysis of sweat production and by expert panel evaluation of photographs of~     the starch-iodine test performed on each axilla. Participants will also be asked to~     subjectively classify the severity of their axillary sweating. These measures will be~     performed at pretreatment and at one, three, and six months following treatment. Biopsies of~     both axillae will be done before and two weeks after treatment to assess histologic changes~     to the eccrine gland and surrounding structures. Treatment of axillary hyperhidrosis with~     the 1210nm diode laser is a novel approach based on the unique absorption characteristics of~     this wavelength. We hypothesize that selective heating of lipids at the appropriate tissue~     level will impact adjacent eccrine glands typically seated at the dermo-hypodermal junction,~     leading to subjective and/or objective decreases in eccrine secretions. This type of~     treatment may offer an effective, non-invasive and safe alternative to current treatment~     modalities.~   "
72700|NCT02105740|"~     This study's aim is to use hypnosis in cancer patients, in order to reduce the level of~     pain, as well as anxiety and depression, as compared to the control group. For this~     evaluation development the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression~     Scale ( HADS) will be used.~   "
72701|NCT02105727|"~     The objective of this study is to determine whether a community-based salt reduction program~     can reduce average salt consumption levels. Baseline levels of salt consumption were~     measured in 2011, the salt reduction program was then implemented, and now in 2014~     investigators are remeasuring salt consumption levels in the community. The hypothesis~     investigators are testing is that the salt reduction program will have led to a change in~     salt consumption levels between 2011 and 2014. The study is being done in Lithgow, a~     regional town in New South Wales , Australia.~   "
72702|NCT02105714|"~     NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded~     by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system~     for delivering primary health care in resource-constrained settings. NIDIAG will investigate~     three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever~     and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current~     study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal~     pain that last for at least 2 weeks.~      While acute diarrhoea has been studied globally, few research activities have focused on the~     epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and~     longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30~     bacterial, parasitic and viral infectious agents. This lack of data may be explained by the~     fact that people suffering from NTDs might only seek care at a late stage of the disease.~     Furthermore, health systems in affected regions are often weak and their primary health-care~     centres are often under-staffed and lack essential diagnostic equipment.~      The hypothesis of this study is that development of an evidence-based syndromic approach can~     lead to better diagnosis and management of NTDs in patients with persistent digestive~     disorders. The study will be carried out in two West African countries (Côte d'Ivoire and~     Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a~     case-control design and patients and controls will be prospectively enrolled. In order to~     address the knowledge gaps, three specific objectives will be pursued. First, the~     contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed.~     Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis~     of target NTDs that give rise to persistent digestive disorders will be determined. Third,~     the clinical response to standard empiric and targeted treatment of several NTDs in patients~     with persistent digestive disorders will be evaluated. These objectives will provide a~     long-term benefit for the communities by improving the clinical decision-making process for~     the target NTDs and thus, better diagnostic work-up and patient management can be achieved~     in the study countries and other similar resource-constrained countries~   "
72703|NCT02105701|"~     This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir~     (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus~     (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated~     interferon and RBV. The primary study hypothesis is that in at least one of the study arms,~     the percentage of participants achieving sustained viral response 12 weeks after the end of~     all study treatment (SVR12) will be superior to 58%.~   "
72704|NCT02105688|"~     This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of~     grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in~     the treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who~     are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of~     participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate~     Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study~     therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1~     dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a~     3-year observational follow-up.~   "
72705|NCT02105675|"~     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care~     therapy can improve survival times for patients with Metastatic Castration Resistant~     Prostate Cancer~   "
72709|NCT02105623|"~     The purpose of this study is to compare standard therapy (risk factor control, life style~     modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on~     progression of coronary atherosclerosis in statin naive individuals who have mild CAD~     (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein)~     cholesterol levels(〈130mg/dl).~   "
72710|NCT02105610|"~     There is initial evidence that the choice of anesthesia can influence survival in the~     specific setting of coronary artery bypass grafting surgery (CABG).~      A recent international consensus conference included volatile agents among the few~     drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and~     that should be further studied. Volatile anesthetics (desflurane, isoflurane and~     sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac~     protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized~     controlled studies were summarized in a meta-analysis that documented a reduction in~     perioperative cardiac troponin release and mortality in patients receiving volatile~     anesthetics when compared to patients receiving a TIVA. There are four published studies~     (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007)~     suggesting that these benefits can translate into a reduced mortality rate in patients~     receiving volatile agents. The level of evidence for these four studies is not high (one~     meta-regression, one underpowered randomized controlled study, one retrospective study and~     one meta-analysis of small randomized studies) and there is need for a large multicentre~     randomized controlled study to confirm these findings, as suggested by the international~     consensus conference on this topic published in 2011 (Landoni et al 2011).~      The purpose is to provide a large multicentre controlled randomized trial to demonstrate~     that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing~     CABG (either with or without cardiopulmonary bypass).~      The results of this study can support the use of volatile agents in all CABG procedures~     worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis~     that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be~     reduced from 3% to 2% using volatile agents).~   "
72711|NCT02105597|"~     Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality worldwide.~     Long-term glycemic control is important to prevent or delay the onset of DM related~     complications. Patients often fail to achieve optimal glycemic control from pharmacotherapy~     due to non-adherence. With the high prevalence of smartphone usage locally and among the~     developed countries, there has been a growing interest to deliver interventions through~     mobile applications. In this study, a mobile application targeted at improving medication~     adherence among people with Type 2 DM will be developed and evaluated.~      Aims: This study aims to (i) design a smartphone application to improve medication adherence~     and (ii) evaluate its impact on clinical outcomes, health-related quality of life (HRQoL)~     and health status among patients with Type 2 DM.~      Hypothesis: The use of a smartphone application can improve medication adherence among~     patients with Type 2 DM, as well as clinical outcomes, HRQoL and health status.~      Methods: This is a randomized, open-label controlled trial involving patients with Type 2 DM~     managed at Singapore General Hospital. Patients seen at the institution's Diabetes Centre~     and those referred to the pharmacist-led Medication Therapy Management service are eligible~     to participate. Patients in the intervention group will have the mobile application~     downloaded onto their smartphones, while those in the control group will receive the usual~     standard of care. The primary outcome will be change in self-reported medication adherence,~     determined using the 8-item Morisky Medication Adherence Scale. Secondary outcomes include~     change in HbA1c, blood glucose, frequency of dose titrations, addition or removal of oral~     hypoglycemic agents, HRQoL (measured using the Audit of Diabetes Dependent Quality of Life)~     and health status (measured using the EuroQol-5D-5L and EuroQol Visual Analogue Scale). All~     outcomes will be measured at baseline and at the end of the 6-month study period (± 4~     weeks).~      Significance: The development and evaluation of a mobile application to improve adherence~     among patients with Type 2 DM in Singapore is the first of its kind, and the findings of~     this study will provide the much-needed evidence to demonstrate the effectiveness of this~     intervention.~   "
72712|NCT02105584|"~     This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech®~     LAA occluder indicated for percutaneous LAA closure in adult male or female patients with~     atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1~     year following implantation of an Occlutech® LAA Occluder.~   "
72713|NCT02105571|"~     The current project is a randomized, controlled evaluation of a new weight loss and health~     promotion intervention for truck drivers. The intervention is a 6-month weight loss~     competition supported with computer based training, behavioral self-monitoring, and~     motivational interviewing. We hypothesize that the intervention will produce greater change~     than a usual practices control condition. Our secondary hypothesis is that social support~     and stress in home and work environments will moderate intervention efficacy.~   "
72714|NCT02105558|"~     To compare the effects of epidural versus CSE anesthesia on the success of TOLAC. This will~     be a prospective clinical study randomizing 60 eligible women into either an epidural group~     or CSE group. The effects of the specific regional anesthetic on patient's individual labor~     efforts will then be closely monitored. Written informed consent shall be obtained to enroll~     the patients in either group. Pain scores and electronic medical record information will be~     used with non-identifiable coding to determine the resulting outcomes.~   "
72715|NCT02105545|"~     The goal of this study is to develop a new, local system that will use special tests based~     on patients' genetic makeup to better tailor cancer care at the University of New Mexico~     Cancer Center.~      The Food and Drug Administration has already approved over forty (40) drugs to treat cancer~     patients based on specific genetic makeup, and more agents are in development that will~     support this new approach to treatment, often referred to as personalized medicine.~      The goal of performing specific tests on patients' genetic material is to discover~     tumor-specific, single nucleotide variations (SNVs) and other forms of genetic changes~     (called epigenetic changes) that can be detected when comparing normal tissue and tumor~     tissue. This can help guide cancer care decisions that may be more effective for patients.~     These will be called clinically actionable findings, or CAF.~      Additional health related findings may be made, not related to cancer but to other~     conditions, diseases or syndromes. These are called secondary findings (SF). In this study~     the investigators will also measure how often they find SF and will discuss their possible~     impact on other aspects of patients' health. If patients want to know about these findings,~     they will be discussed with a panel of experts including genetic counselors.~      Finally, the investigators will compare how often CAF and SF differ from those identified in~     nationwide samples.~   "
72716|NCT02105532|"~     Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell~     (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal~     Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised~     controlled trial.~   "
72717|NCT02105519|"~     In recent years, several studies revealed that the current influenza vaccine strategy might~     be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and~     mortality in the end-stage renal disease population than previously thought. Thus, this also~     raised the question about the effectiveness of administration of influenza vaccination in~     chronic kidney disease patients not on dialysis. In this study, the investigators aim to~     evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014,~     in patients with different stage of chronic kidney disease (CKD) not on dialysis.~   "
72727|NCT02105389|"~     Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults~     receiving treatment for cancer, and intensively treated patients may be at higher risk.~     While exercise is an effective intervention for CRF, patients receiving the most intensive~     chemotherapy may frequently be too ill to participate in a standardized exercise program. A~     unique intervention that combines exercise and relaxation is yoga. This pilot study will~     evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga~     instructor for a three week duration and will enroll between 10 and 20 children. If~     feasible, the intervention will be tested in a randomized controlled trial.~   "
72718|NCT02105506|"~     Rationale: The construction of esophageal anastomoses is associated with considerable risk~     at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human~     fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially~     prevent anastomotic leakage.~      Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal~     anastomoses.~      Study design: Non-randomized, non-blinded, single-center intervention study. Study~     population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an~     esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be~     enrolled. A total number of 15 patients will be included in the study.~      Intervention: Gastric or esophageal resection will be executed according to the common~     procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all~     enrolled participants will receive a TachoSil® patch, which will be applied on the~     esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy.~     TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after~     application.~      Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by~     evaluation of adherence of the patch. A time-action analysis of the application of the~     Tachosil patch will be performed.~      Nature and extent of the burden associated with participation: The burden for the patient is~     minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative~     care and outpatient visits do not differ from regular protocol. TachoSil® is approved and~     registered for supportive treatment in surgery for improvement of haemostasis and to promote~     tissue sealing by the European Commission.~   "
72719|NCT02105493|"~     Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade.~     However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial~     access and potentially limits the radial artery as an access site in the future. Several~     strategies have been used to decrease the incidence of RAO including the use of~     anticoagulation, maintenance of patency during hemostasis, or shortening the duration of~     compression. Currently, there is no data whether vasoactive pharmacological therapy such as~     nitroglycerin administered intra-arterially at the end of the procedure may reduce the~     incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor)~     at the end of a TRA procedure may reduce the incidence of RAO.~   "
72720|NCT02105480|"~     The purpose of this double-blind pivotal clinical utility study is to determine on a large~     patient population whether heart murmurs can be reliably detected with high sensitivity and~     specificity using a locked, automated algorithm-based phonocardiogram analysis (also~     referred to as computer aided auscultation (CAA)).~      Each patient is auscultated and diagnosed independently by a medical specialist.~     Additionally, for each patient, an echocardiogram is performed as the gold-standard for~     determining heart pathologies. The CAA results are compared to the findings of the medical~     professionals as well as to the echocardiogram findings.~      Hypothesis: The specific (locked) CAA algorithms used in this study are able to~     automatically diagnose pathological heart murmurs in premature babies and newborns with at~     least the same accuracy as experienced medical specialists.~   "
72721|NCT02105467|"~     This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir~     (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT)~     1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment~     or deferred treatment (placebo control). The primary efficacy hypothesis was that the~     proportion of participants receiving combination therapy in the Immediate Treatment Arm who~     achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is~     superior to 73%.~   "
72722|NCT02105454|"~     In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior~     direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir~     (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug~     combination.~   "
72723|NCT02105441|"~     Do adults and older children (greater than 7 years of age) with unilateral or assymetric~     hearing loss benefit from cochlear implantation on the worst hearing side.~   "
72724|NCT02105428|"~     A goal of this study is to use a novel methodology to determine whether insulin resistance~     in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins~     with modifications. This could lead to future research to determine if these modifications~     interfere with their proper function. Additionally, the investigators will determine how~     protein quality is affected by exercise training. Aerobic exercise enhances the endogenous~     oxidant buffering systems which may minimize oxidative damage to proteins. The investigators~     propose that aerobic exercise minimizes the accrual of modified proteins by increasing the~     synthesis of new proteins, but also by increasing the degradation and removal of old and~     damaged proteins. Based on our previous studies the investigators observed that insulin~     affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only~     in muscle but also in liver. The investigators therefore propose that aerobic exercise and~     related increase in insulin sensitivity (and decline in insulin levels) will reduce~     accumulation of old and modified skeletal muscle and plasma proteins leading to improved~     function.~   "
72725|NCT02105415|"~     The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable~     hemodynamics as compared to Etomidate during emergent intubations in the intensive care~     unit. Patients that require a breathing tube to be placed in the ICU will be randomized to~     receIve either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the~     breathing tube.~   "
72726|NCT02105402|"~     The purpose of this study is to carry out a high-level treatment efficacy study on children~     with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled~     Randomized Controlled Trial design.~      The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets~     (PROMPT) approach, which has been effective in treating motor speech disorders in adults and~     in children with autism and cerebral palsy.~   "
72728|NCT02105376|"~     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as~     primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on~     depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items~     (HDRS-17) in patients with moderate / severe depressive episode.~   "
86932|NCT01919515|"~     The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform~     similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of~     primary molar teeth.~   "
72730|NCT02105350|"~     This is a phase I study (an early study to check the safety of a new drug or drug~     combination) to find the safest and most tolerated dose of the combination of oxaliplatin~     with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers~     and cancers associated with the bile ducts leading from the gallbladder and to and from the~     liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where~     cancer started). Everyone will receive the same standard doses of oxaliplatin and~     gemcitabine but may receive different doses of MEK 162.~      MEK 162 is a new drug which plays an important role in the regulation of cell growth and has~     been shown to shrink tumours in patients with biliary cancer and other types of human~     cancers. This type of drug has also been shown to shrink tumours when given in combination~     with cisplatin and gemcitabine in research studies done in animals and in some patients with~     biliary cancer.~   "
72731|NCT02105337|"~     The purpose of this study is to determine if a clear barrier placed over the eyes has any~     effect on goggle monitoring. When a patient has general anesthesia they lose the ability to~     blink and their eyes may dry. They may also lose the ability to keep their eyes fully~     closed. The anesthesiologist takes several steps to prevent injury to the eyes. First the~     eyes will be lubricated with ointment and the eyelids will be held in a closed position by~     the use of a clear barrier. During pituitary surgery it is the routine practice to perform~     many types of monitoring. One type of monitoring is to stimulate your eyes with a light.~     This helps your surgeon protect the nerve supply to your eyes. The light is supplied by a~     pair of goggles placed over your eyes during surgery.~      To help achieve our objective, the investigators are asking patients who are undergoing~     pituitary surgery to give us permission to record two sets of numbers form the monitoring~     device once prior to the application of the clear barrier and the second after the barrier~     is applied. This will be done when the patient is already asleep and will not be aware this~     is happening.~   "
72732|NCT02105324|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improve glycemic control vs. usual care~     for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.~   "
72733|NCT02105311|"~     The investigators conduct this study to access the effect of selective laser trabeculoplasty~     on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension~     glaucoma and ocular hypertension. This treatment effect is compared with that of the~     prostaglandin analogue, travoprost.~   "
72734|NCT02105298|"~     Intraoperative intravenous fluid management practice varies greatly between~     anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity.~     Postoperative respiratory complications are associated with increased morbidity, mortality~     and hospital costs. The literature shows conflicting data regarding intraoperative fluid~     resuscitation volume. No large-scale studies have focused on intraoperative fluid management~     and postoperative respiratory dysfunction.~      Hypotheses:~      Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of~     30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with~     increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation,~     atelectasis, acute kidney injury and peri-extubation oxygen desaturation.~   "
72735|NCT02105285|"~     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic~     solution in comparison with carteolol long-acting ophthalmic solution in subjects who are~     insufficiently responsive to carteolol long-acting ophthalmic solution.~   "
72736|NCT02105272|"~     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic~     solution in comparison with latanoprost ophthalmic solution in subjects who are~     insufficiently responsive to latanoprost ophthalmic solution.~   "
72737|NCT02105259|"~     The overall aim of this study is to develop and test a psychodynamic Internet--delivered~     psychological treatment for patients with social anxiety disorder and compare its efficacy~     to a waiting list.~   "
72738|NCT02105246|"~     The long-term goal of this research is to improve patient-centered outcomes in patients with~     coronary heart disease (CHD). CHD is the leading cause of death in the world. Exercise-based~     cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in~     patients with CHD. Published guidelines recommend exercise-based CR following~     hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous~     coronary revascularization, and referral to CR is one of nine performance measures~     established by the American Heart Association and American College of Cardiology for~     patients with CHD.~      Despite these compelling benefits, CR programs are vastly underutilized, with less than a~     third of eligible patients participating. The largest barrier to patient participation is~     that CR must be provided in a physician's office or hospital setting to qualify for~     reimbursement. For this reason, virtually all existing CR programs require that the patient~     travel to a CR center 3 times per week for 12 to 36 weeks. Unfortunately, many Americans~     live too far from a CR center to enroll, and even when nearby programs are available, many~     patients do not have the time, flexibility, transportation, social support, and/or financial~     resources to attend.~      One promising solution to the problem of CR under-utilization is greater implementation of~     home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular~     risk factors and quality of life. However, similar efficacy does not necessarily translate~     into similar effectiveness. If patients are more likely to participate in home- vs.~     center-based therapy, then greater participation could lead to greater clinical~     effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA~     medical centers to determine the comparative effectiveness of referral to home- vs.~     center-based CR in patients with CHD.~      Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient~     participation in CR after hospitalization for myocardial infarction or coronary~     revascularization.~      Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home-~     vs. centerbased CR on six-minute walk distance, quality of life, and healthcare~     expenditures.~      Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender,~     race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or~     patient preference.~      Results from this study will (a) help policy makers determine the effect of covering home CR~     on healthcare expenditures in patients with CHD; (b) help providers understand the potential~     benefits and harms of home- vs. center-based CR; and (c) help patients answer questions~     like, Given my personal circumstances and preferences, which of these options will improve~     the outcomes most important to me.~   "
72755|NCT02105025|"~     Colonoscopy is the current common method for management of colorectal diseases, and~     effectiveness of colonoscopy associate with complication rate. A lot of patients were failed~     because of technical difficulty, those required more than 10 min to intubate the cecum are~     consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may~     be required for a successful colonoscopy. Thus, it is important to set up a clinical model~     to predict the technical difficulty of the examination in preoperational stage.~   "
72756|NCT02105012|"~     This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment,~     incomplete block, cross-over, multicenter study to assess the efficacy and safety of four~     doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult~     subjects with mild to moderate persistent asthma.~   "
72739|NCT02105233|"~     Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains~     unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are~     increasing. There seems to be an agreement that achieving extensive resections, when done~     safely without jeopardizing neurological function, improves survival.~      Ultrasound is currently used as a tool for providing 2D or 3D images for the purpose of~     tumor localization and resection control. For the use in resection control the resection~     cavity is filled with saline to provide acoustic coupling between the ultrasound transducer~     and tissue. However, attenuation of acoustic waves is very low in saline compared to the~     brain and this difference in attenuation is the cause of artifacts that may severely degrade~     the ultrasound images. Such artifacts are seen as high-intensity signal at the resection~     cavity wall and beyond, potentially masking small tumor remnants and generally making the~     interpretation of images more difficult.~      This research group has developed an acoustic fluid intended for use in the resection cavity~     instead of saline. Tests in laboratory measurements have shown that the fluid reduces~     artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery.~     The investigators expect that the acoustic fluid will make it easier to detect small tumor~     remnants near the end of an operation, thus increasing success of glioma surgery. The~     purpose of this study is to test the fluid during surgery for histopathologically proven~     glioblastoma to assess safety and efficacy.~   "
72740|NCT02105220|"~     The goal of this study is to describe the influence of the chest wall on the respiratory~     system mechanics in morbidly obese patients and in patients with high intra-abdominal~     pressure.~      The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest~     wall and total respiratory system mechanics, lung volumes and gas exchange will be~     evaluated, both during controlled and assisted mechanical ventilation.~      Patients will be studied, first, during the acute phase of respiratory failure, when~     requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated~     again during weaning from the ventilator to assess the influence of PEEP in assisted~     ventilation prior to extubation.~   "
72741|NCT02105207|"~     For patients presenting to the Emergency Department with acute dyspnea, emergency physicians~     will be asked to categorize the diagnosis as acute decompensated heart failure or~     non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after~     performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and~     natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those~     enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of~     patient's dyspnea will be determined by independent review of the entire medical records~     performed by two emergency physicians. In case of disagreement, a third expert physician~     will review entire medical records, and adjudicate the case.~   "
72742|NCT02105194|"~     Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression~     illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging~     tracks and is consistent with the clinical condition of the patients.~   "
72743|NCT02105181|"~     Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation~     and/or plastic stent placement are currently the most popular techniques. Partially covered~     self-expandable metallic stents have also shown to be effective but can be difficult to~     remove. A novel fully covered metallic stent has recently been developed.~      The aim of this study was to prospectively evaluate the placement of fully covered~     self-expandable metallic stents (FCSEMS) in this setting.~   "
72744|NCT02105168|"~     Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as~     chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of~     why those patients are relapsing using next generation sequencing to identify rare mutations~     and assessed their predictive value.~   "
72745|NCT02105155|"~     The best period for the conversion from Prograf (tacrolimus administered twice daily) to~     Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this~     prospective, randomized, multicenter trial is to prove the non-inferiority of the early~     conversion (at D7) versus the conversion at D90 after liver transplantation. The primary~     objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the~     6 first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the~     conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two~     strategies will be compared in terms of superiority. 250 patients will be included. Three~     ancillary studies will be added : a PK study in a subgroup of 40 patients (20 patients per~     arm), an assay of the calcineurin activity on a subgroup of 40 patients, and a~     medicoeconomic study in all patients~   "
72746|NCT02105142|"~     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder~     of childhood, affecting approximately 8% of youth. Children with ADHD often have problems~     sustaining attention and completing multi-step commands and tasks of daily living, such as~     homework. Pediatricians are often the first physicians to identify problems with children's~     functioning at home and at school. However, because of limited visit time, pediatricians~     often struggle with managing ADHD while trying to also cover a vast array of other primary~     care issues. Moreover, as there is a nationwide shortage of pediatric mental health~     specialists and access to parenting programs is limited, a critical need exists to develop~     interventions that form partnerships between behavioral and mental health specialists and~     the primary care pediatrician. One approach is to base interventions in the pediatric clinic~     to ensure children have access to appropriate treatment. Thus far, only a limited number of~     sites have this pediatric-mental health partnership.~      Health information technology (HIT) has been used to enhance primary care management of~     ADHD. HIT can improve pediatricians' ability not only to adhere to recommended guidelines,~     but also to screen for co-existing disorders and provide timely parental education. An~     alternative strategy might be to use group visits (GV). GV afford more time with families~     and allows the pediatrician to facilitate more in-depth discussions. More importantly, the~     group model allows parents to learn from one another, normalizes parenting expectations, and~     addresses shared experiences of medication side effects and other factors related to~     adherence. Moreover, a group visit can be conducted in a physical location, such as the~     pediatric clinic, or be brought into the virtual world with the aid of social media. Virtual~     support groups for chronic care diseases have become an increasingly popular way for a~     community of individuals to exchange information and offer emotional support.~      Prior to the adoption of these interventions into primary care practice, investigators must~     know which is best. Rigorous comparative effectiveness research (CER) can help to determine~     this. This proposal will compare a HIT based intervention to a GV strategy, with and without~     the use of social media. These 3 interventions will be compared based not only on clinical~     measures of interest but also on parent-defined patient outcomes. Prior research has largely~     focused on measuring clinical outcomes such as treatment adherence and ADHD symptom~     reduction with little emphasis on understanding how patient-centered outcomes, such as the~     quality of life of families dealing with ADHD, are affected.~      Building on previous work, the specific aims for this study are:~      Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD~     in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on~     clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning~     Aim 1b) Compare the effectiveness of the three interventions on patient-centered outcomes~     such as quality of life and parental satisfaction with the intervention The three~     interventions will be: 1) Child Health Improvement through Computer Automation (CHICA) which~     is the health information technology innovation arm; 2) Group visits (GV); or 3) Group~     visits plus online discussion portal (GV+DP).~   "
72747|NCT02105129|"~     The primary objective of this study is to assess the safety and tolerability of a single~     dose of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg~     under fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions~     of a standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in~     Part B, in healthy male volunteers.~      The secondary objective is to determine the pharmacokinetic profile of single (Part A) and~     multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the~     preliminary effect of food (Part C）~   "
72748|NCT02105116|"~     This pilot clinical trial studies if cells donated by a close genetic relative can help keep~     acute myeloid leukemia (AML) from coming back after standard chemotherapy induces a complete~     remission. Blood cells obtained from a donor include a variety of blood cells that may~     trigger the patient's immune system to react against AML cells.~   "
72749|NCT02105103|"~     Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek®~     Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational,~     multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in~     routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been~     on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All~     subjects will receive training in the preparation, programming and daily use of the~     Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more~     training in order to be comfortable with the use of an insulin pump. The study will be~     conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95~     subjects will be enrolled in this study.~   "
72760|NCT02104960|"~     This study aims to evaluate skin aging of an homogeneous population of 77 years old patient~     selected among the PROOF cohort who has been continuously investigated by cardiological~     examination.~      Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin~     aging will be measured by an index of clinical aging (SCINEXA) and other complementary~     measures such as facial photos, standard and High Definition dermoscopy, elastography,~     sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.~   "
72761|NCT02104947|"~     Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of~     5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled~     bleeding or require emergency surgery or procedures.~   "
72762|NCT02104934|"~     Total knee arthroplasty or replacement (TKA), a commonly performed surgery for~     osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic~     approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of~     drugs is injected around the knee joint.~      Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been~     shown to result in minimal thigh weakness.~      The investigators aim to study if the analgesia provided by ACB is superior to LIA while~     preserving quadriceps strength.~   "
72763|NCT02104921|"~     This study is utilizing ultrasound measurement to measure neuromuscular disease status in~     adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that~     ultrasound can be utilized as a tool to determine if a disease is responding to therapy or~     progressing.~   "
72764|NCT02104908|"~     The investigators aim to examine target-controlled propofol infusion as a technique of~     anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus~     block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which~     regional anesthesia was more sufficient for the old.~   "
72765|NCT02104895|"~     The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole~     breast radiotherapy to accelerated partial breast irradiation using intensity-modulated~     radiotherapy technique in selected early breast cancer patients after breast conserving~     surgery.~   "
72766|NCT02104882|"~     Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery~     and radiochemotherapy, the tumors are likely to grow back very quickly.~      Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy~     tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or~     subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain~     have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al.~     1995; Ortiz de Urbina et al. 1995).~      However, the full potential of the procedure is to date largely unexplored as most previous~     studies used forward-scattering (electron-based) irradiation techniques, which frequently~     led to inadequately covered target volumes. With the advent of the spherically irradiation~     devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even~     complex cavities can be adequately covered with irradiation during IORT. However, there is~     no data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this~     system.~      The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered~     intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal~     of the study is to find out whether the procedure may improve survival rates.~   "
72767|NCT02104869|"~     This will be an open label, parallel, randomized clinical trial that will evaluate the~     immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented)~     produced by Instituto Butantan among adult kidney transplant recipients, when administered~     in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two~     doses administered with a 21 day interval.~      The randomization ratio among the three groups of kidney transplant recipients will be 1:1,~     and 60 participants will be included in each group. After vaccination all participants will~     be followed for 26 weeks.~      In addition, 15 healthy adults will be included as a control group, and will receive the~     recommended dose.~      The study hypothesis is that a different vaccination regimen can improve the immune response~     of kidney transplant recipients after vaccination with the trivalent influenza vaccine~     (inactivated and fragmented).~   "
72768|NCT02104856|"~     The primary objective of this Registry is to collect real-world data on patients undergoing~     bronchial thermoplasty (BT) treatment.~   "
72769|NCT02104843|"~     The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir~     (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.~   "
72770|NCT02104830|"~     The purpose of the study is to compare safety and efficacy of a single dose of~     empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients~     receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).~   "
72771|NCT02104817|"~     The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group~     design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL~     and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin,~     once daily, for approximately 3-5 years as determined when the number of MACE outcomes is~     reached.~   "
72772|NCT02104804|"~     A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety~     of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in~     Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on~     Insulin Alone or on Insulin in Combination with Metformin~   "
72773|NCT02104791|"~     It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic~     subclinical infection.~   "
72774|NCT02104778|"~     The aim of the present study is to test that adding dexamethasone or epinephrine~     significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the~     magnitude of the effect differs among dexamethasone and epinehrine.~   "
72775|NCT02104765|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body~     processes the drug and how the drug affects the body. The study is expected to last about 5~     to 7 months, depending on the arm.~   "
72776|NCT02104752|"~     The investigators propose to test whether curcumin nanoparticles will improve behavioral~     measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who~     are already receiving a stable dose of antipsychotic.~   "
72779|NCT02104713|"~     This study will determine the safety of allogeneic stem cell therapy from healthy donors,~     for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four~     different dose levels.~      Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and~     then monthly for 6 months following the last administration of MSCs.~      Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will~     be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase~     1 will establish the maximum safe dose that will be used in the Phase II trial.~   "
72780|NCT02104700|"~     The study will be an open-label, pilot study in virologically suppressed patients comparing~     the efficacy, safety and tolerability of two Antiretroviral regimen strategies:~      Arm A: Immediate switch Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation~     (STF))at randomization~      Arm B: Delayed switch Continue Nevirapine/Lamivudine/other Nucleoside reverse~     transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of~     Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.~   "
72781|NCT02104687|"~     The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on~     cardiac index trending by transesophageal Dopplerometry would result in reduced~     complications and reduced length of hospital stay in major abdominal surgery patients, when~     compared to patients treated with press treatment algorithm.~   "
72782|NCT02104674|"~     This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess~     the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma~     treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in~     a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous~     (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair~     (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.~   "
72783|NCT02104661|"~     People with multiple sclerosis (MS) have nerve loss even without acute inflammatory~     relapses, as obvious in the progressive phase of disease. Drugs that may prevent nerve loss~     work better in earlier stages when it is difficult to measure progressive disability. But it~     is now possible to measure the nerve loss as neurofilament light (NFL) in the cerebrospinal~     fluid (CSF). This is a trial of a neuroprotective drug, oxcarbazepine, which showed benefit~     in an animal model of multiple sclerosis. The investigators will use an innovative outcome,~     a reduction in the content of NFL in the CSF, as well as the usual clinical disability and~     imaging methods, to measure the success of the oxcarbazepine as a neuroprotective agent in~     MS. The use of NFL, a surrogate marker of neurodegeneration, allows a blinded and accurate~     outcome.~   "
72784|NCT02104648|"~     This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of~     RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in~     healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized,~     double-blind, placebo-controlled study. Participants will be randomized to receive daily,~     oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a~     multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control,~     parallel group study. Participants will be randomized to receive either multiple or single~     doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic~     parameters will be assessed for Parts A and B; and continuous ECG recordings will be made~     during Part B.~   "
72785|NCT02104635|"~     This research represents a randomized trial of a program to improve timely postnatal care,~     comparing post-natal check-ups performed by community health workers delivered either by~     phone or in person to a control group. The study hypothesis is that when community health~     workers check on women three days after their delivery we will see improvements in the~     detection of maternal and child complications, better knowledge of complications and an~     increase in behaviors that are expected to lead to improved maternal and child health.~   "
72786|NCT02104622|"~     Many people with spinal cord injury are no longer able to walk and must use wheelchairs for~     mobility. These individuals experience greater rates of depression and lower quality of~     life. Many of these individuals express a strong desire to walk again, and report many~     psychosocial benefits to being eye to eye with peers in social interactions. Additionally,~     wheelchairs allow only limited community access, creating an additional obstacle to seeking~     out meaningful social roles in the community. Currently, there is new technology called~     robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic~     exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to~     community access. Current research has examined training with robotic exoskeletons indoors~     over level surfaces in clinical settings. This study will examine the potential for everyday~     use, including ramps, stairs, curbs and indoor and outdoor use.~   "
72787|NCT02104609|"~     The purpose of this study is to determine the effects of obesity on the pharmacokinetics of~     the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of~     ovulation~      Primary hypothesis:~      1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger~     volume of distribution of LNG.~      Secondary hypothesis:~        1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women~          affect the primary mechanism of action, which is inhibition of ovulation.~        2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding~          globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free~          LNG.~   "
72788|NCT02104596|"~     Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in~     patients with knee osteoarthritis (OA).~   "
72789|NCT02104583|"~     This study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the~     overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions~     (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization~     therapy-defibrillator (CRT-D).~   "
72790|NCT02104570|"~     The purpose of this study is to investigate the effects of Kinesio Taping on the position~     sense of shoulder after muscle fatigue.~   "
72791|NCT02104557|"~     Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception~     And Management Of Endometriosis-Associated Pain~   "
72815|NCT02104245|"~     This study (ARD-3150-1201, ORBIT-4) will evaluate the safety and efficacy of inhaled~     Pulmaquin compared to inhaled placebo in subjects who have a confirmed diagnosis of~     non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and~     chronic P. aeruginosa infections.~   "
72792|NCT02104544|"~     This is a multi-center, cross-sectional, non-interventional, observational study——an~     investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant week 39±2~     group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7~     group) from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1~     lake regions) in China to study the correlation between DHA intake and DHA concentrations in~     blood and breast milk.~   "
72793|NCT02104531|"~     The investigators purpose is to determine the ability of a low cost, currently available~     imaging technique to predict shoulder movement disorders and the location of shoulder~     disease based on motion analysis of subjects with known shoulder disorders.~   "
72794|NCT02104518|"~     In this study the investigators propose to evaluate the performance of several G6PD testing~     platforms.~   "
72795|NCT02104505|"~     To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin~     induced airways inflammation in allergic asthmatics~   "
72796|NCT02104492|"~     Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the~     central nervous system and the second leading cause of disability in young adults. Motor~     deficits also involve respiratory muscles. This involvement is present from early stages of~     disease and is frequently dismissed by professionals until advanced stages of disease. The~     effect of a training program of respiratory muscles is not sufficiently studied. The aim of~     this research is to assess the clinical and functional response of a 12-week respiratory~     muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis~     (RRMS).~      This study is consisted with two sub research:~      Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with~     RRMS. Participants either will be received (n = 20) peripheric resistive muscle training~     program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP)~     with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they~     will be received peripheric resistive muscle training program and health education program.~     Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory~     and expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed~     the quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index),~     fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical~     muscle strength (Multiple-Sit-to-Stand Test and handgrip strength).~      Secondly, the qualitative research where researchers will interview participants about their~     interest in carrying out the intervention (difficulties and advantages) and identify themes~     of interest about changes in quality of life.~   "
72797|NCT02104479|"~     Diagnostic accuracy of biomarker testing (galactomannan (GM), (1~   "
72798|NCT02104466|"~     Peripheral neuropathy is a common complication of diabetes, and one of the strongest~     determinants of reduced health-related quality of life among people with diabetes.~     Neuropathy frequently presents with painful symptoms, activity limitation, insomnia,~     fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at~     least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN),~     but often decrease other domains of quality of life through adverse effects, such as dry~     mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical~     approaches for PDN are needed, particularly for low income and racial/ethnic minorities who~     are at highest risk of diabetes and related complications. Acupuncture is a promising~     treatment for PDN, but evidence is limited. To address the significant public health need~     related to pain management among underserved people with diabetes, this study proposes an~     innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty~     patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care~     combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12~     weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims~     of the study are to determine the feasibility of group acupuncture for PDN among underserved~     patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture~     on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve~     conduction velocity, and protective sensation; and to determine the optimal frequency of~     acupuncture treatments.~      The investigators hypothesize that compared to patients receiving usual care alone, patients~     who undergo weekly group acupuncture treatments will have:~        1. decreased pain intensity~        2. improved health-related quality of life~        3. improved sural nerve conduction velocity~   "
72799|NCT02104453|"~     One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust,~     and two-handed mask ventilation with triple airway maneuver are three common airway~     management maneuvers. Sniffing position may improve ventilation between these three~     maneuvers. The investigators hypothesize that ventilation efficiency may be different~     between these three maneuvers whether the patient is in sniffing position or neutral~     position. The investigators would like to quantify this effect by measuring the expired~     tidal volume, airway pressure, EtCO2 slope and hemodynamic change between these three~     maneuvers during anesthesia induction.~   "
72800|NCT02104440|"~     The purpose of this study is to evaluate the safety and efficacy of the sequential infusion~     of allogeneic mesenchymal stem cells (MSC), expanded in vitro with platelet lysate without~     addition of animal products in the treatment of patients undergoing allo-HSCT who developed~     one or more cytopenias.~   "
72801|NCT02104427|"~     This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF~     in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin~     lymphoma or Hodgkin disease.~   "
72802|NCT02104414|"~     The purpose of this study is to compare the quality and duration of pain relief after a~     hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine~     hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more~     effective postoperative pain relief than both bupivacaine hcl and the control.~   "
72803|NCT02104401|"~     This research will help us to understand whether transcranial direct current stimulation~     (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in~     people with Parkinson's disease and related disorders. Some of the disorders that will be~     studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System~     Atrophy (MSA) and progressive supranuclear palsy (PSP).~   "
72804|NCT02104388|"~     The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in~     promoting corneal epithelial wound healing in conditions associated with corneal epithelial~     disorders.~   "
72816|NCT02104232|"~     Background The rates of perinatal depression in South Asian women are reported to be amongst~     the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In~     addition to its profound impact on women's health, disability and functioning, perinatal~     depression is associated with poor child health outcomes such as pre-term birth, infant~     under-nutrition and stunting. There is robust evidence that perinatal depression can be~     effectively managed with psychological treatments delivered by non-specialist health care~     workers. The Thinking Healthy Program (THP), a psychological treatment delivered by~     community health workers (CHWs) in Pakistan, more than halved the rate of perinatal~     depression among mothers and led to significant improvements in child health outcomes. To~     enhance access to such evidence-based psychological treatments there is a need to examine~     the potential role of other human resources such as lay persons in delivering psychological~     treatments such as THP in poor resource settings.~      Objective To evaluate the effectiveness and cost-effectiveness of THP delivered by peers~     (the Thinking Healthy Program-Peer delivered in Goa, India; THPP-I) over the duration of 6~     months. Peers will be healthy mothers who live in the same community as potential trial~     participants (TPs).~      Study design and outcomes Individual randomized controlled trial in Goa, India involving 280~     women. TPs will not be blinded to treatment allocation. Mothers attending antenatal clinics~     at hospitals will be assessed for eligibility to participate in the trial (e.g. whether they~     are in the second or third trimester of pregnancy). Those who are eligible will be invited~     to participate in screening for depression; mothers who consent will be screened for~     depression with a locally validated version of the Patient Health Questionnaire (PHQ-9).~     Women who screen positive (PHQ-9 score ≥ 10) and give informed consent for further~     participation in the trial will be randomly allocated in a 1:1 ratio to receive enhanced~     usual care (EUC) or THPP-I+EUC, using a computer generated allocation sequence. The primary~     outcomes will be remission (i.e. recovery from depression and depressive symptoms), both~     assessed by the PHQ-9 at 6 months. Secondary outcomes are depressive symptoms and remission~     at 3 months (PHQ-9), maternal disability at 3 and 6 months (measured with the WHO-DAS),~     perceived social support, breastfeeding rates and infant weight and height of children at 3~     and 6 months. Outcomes will be analyzed on an intention to treat basis.~      Interventions EUC will comprise communicating the results of the screening to the mother~     through an information sheet on self-care for mental health, communicating the results to~     the mother's gynaecologist, providing the gynaecologist with the WHO mhGAP guidelines for~     the treatment of depression, and providing guidance on referral of depressed mothers to~     mental health services. TPs who are in the THPP-I group will receive, in addition to EUC,~     between 6 to 14 sessions of THPP starting from their recruitment in the second/ third~     trimester until up to 6 months after child birth. Sessions will be delivered by peers on an~     individual basis at a location of convenience to the TPs (usually at their own homes).~      Implications THPP-I has the potential to advance knowledge of the extent to which~     task-shifting of the delivery of evidence-based psychological treatments can be extended to~     peers in the community. If effectiveness is observed, this approach offers a potential~     opportunity to access a vast untapped human resource for maternal mental health care and~     addresses a major barrier in global mental health - the lack of skilled and motivated human~     resources in the formal health sector - offering a new avenue for the scaling up of~     evidence-based psychological treatments and mental health services in low resourced~     settings.~   "
72817|NCT02104219|"~     The purpose of this study is to characterize the natural history of HPP in patients with~     Juvenile-onset HPP.~   "
72818|NCT02104193|"~     The purpose of the study is to evaluate the effect of simvastatin in combination with~     radiotherapy on the clinical outcomes of patients with brain metastases.~   "
72819|NCT02104180|"~     Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with~     removal of wound dressing during care of venous leg ulcer~   "
72805|NCT02104375|"~     Cardiovascular disease (CVD) continues to be the major cause of morbidity and mortality in~     western countries. It has been shown that CVD events are known to be higher in the winter~     than in the summer. Low environmental temperatures may induce increased cardiovascular~     stress resulting in cold-induced hypertension (CIH), the leading risk factor for CVD events.~     Similar to whole-body cold exposure, the cold pressor test (CPT), an external local cold~     stimulus, has been used for evaluation of cardiovascular and hemodynamic reactivity to~     sympathetic stimulation. It has been shown that brachial blood pressure (BP), pressure pulse~     wave reflection, aortic BP, heart rate (HR), and arterial stiffness are increased during~     CPT. However, the physiologic mechanisms for the cardiovascular complications related to low~     temperatures are not completely clear.~      Isometric-handgrip (IHG) exercise has been used as a tool for assessing cardiovascular~     autonomic control by a maneuver defined as post-exercise muscle ischemia (PEMI). PEMI~     induces exercise pressor reflex (metaboreflex) by trapping metabolites in the previous~     active muscle at the cessation of exercise. During PEMI, the accumulation of~     contraction-derived metabolites induces sympathetic mediated vascular stimulation and an~     increased BP, whereas the HR fully recovers. This suggests that the fall in HR is evoked by~     an increase in parasympathetic activity which overpowers the sympathetic activation.~     Implication of IHG exercise followed by PEMI provides important clinical information because~     impaired autonomic and cardiovascular functions are associated with cardiovascular events.~      Recently, oral supplementation with the amino acid L-citrulline (L-cit) has been proposed as~     a possible adjunct treatment for hypertension and arterial stiffness. L-cit is known to~     enhance the bioavailability of L-arginine (L-arg), the endothelial substrate for nitric~     oxide (NO) production. Cold exposure might include a temperature-dependent inhibition of~     endothelial NO synthase (eNOS), the enzyme that produces NO from the amino acid L-arg and~     may trigger various types of CVD. It has been shown that L-cit supplementation has~     effectively attenuated the CIH response during cold pressor test. Thus, L-cit~     supplementation may be effective to reduce the cardiovascular responses associated with cold~     exposure and the exercise pressor reflex imposed by PEMI. Therefore, the proposed study is~     important for the following reasons: (1) the results of his study will add to our~     understanding regarding the cardiovascular and autonomic mechanisms associated with exercise~     and cold exposure; (2) the results of this study will contribute to the development of an~     adjunct therapy for the prevention of cardiovascular adverse events that are particularly~     increased during stress such as cold exposure and exercise.~   "
72806|NCT02104362|"~     Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive~     treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up,~     the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low~     risk and intermediate risk tumors. In parallel with these encouraging results regarding~     biochemical control, the authors described excellent urinary and digestive tolerance,~     notably the absence of grade > 2 complications. However, it should be noted, in this study,~     that special protection was provided to the anterior aspect of the rectum by means of a 10~     ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.~      The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team~     of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90%~     local control rate for spinal metastases after a single dose at 18 to 24 Gy.~      The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days)~     observed following interstitial high dose rate prostate brachytherapy delivering a total~     dose of 20 Gy in one fraction.~   "
72807|NCT02104349|"~     The objective of this study is to evaluate the effect of mindfulness meditation technique on~     post-operative pain of spine surgery subjects. Subjects will participate in a 6-week~     mindfulness meditation program, beginning two weeks prior to spine surgery. The~     investigators are interested in determining if this intervention improves the ability to~     tolerate pain and reduces anxiety, thus reducing the need for prescribed analgesics and~     narcotics. The meditation intervention will be compared against a control group consisting~     of subjects that will undergo music therapy during the same period of time.~   "
72808|NCT02104336|"~     Treatment of Pediatric Subjects with Pearson syndrome~   "
72809|NCT02104323|"~     1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant~     human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of~     the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized~     double-blind trial.~   "
72810|NCT02104310|"~     For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI)~     scan. In this study, information from a special scan, called a Positron Emission Tomography/~     Computed Tomography (PET/CT) scan using an amino acid called~     Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and~     guide your radiation oncologist in determining locations to treat with radiation. This type~     of scan has shown promise in being able to better distinguish tumor from normal brain tissue~     and may help to more accurately plan radiation treatment. This type of scan can also assist~     the radiation oncologist in identifying the most aggressive regions of the tumor. The goal~     of this study is to use the 18F-DOPA PET/CT scan to help determine where the disease is that~     needs to be treated with radiation, in order to improve the effectiveness of radiation in~     this tumor.~   "
72811|NCT02104297|"~     To compare the effect of two different agents deksmedetomidine, remifentanil and placebo,~     agitation and recovery condition, on nasal septum operation.~   "
72812|NCT02104284|"~     Asthmatic patients and non-asthmatic controls were recruited prospectively from four~     referral hospitals in Korea. Participants were challenged with each of methacholine and~     mannitol inhalation on different days. Their diagnostic utility was evaluated by calculating~     their sensitivity and specificity for asthma diagnosis. Response-dose-ratio was also~     compared.~   "
72813|NCT02104271|"~     There is a wide variability of options for treatment of chronic radiation proctitis.~     However, studies are still limited, usually case reports from a single center and few are~     comparative studies between methods. Therefore, the choice of treatment is determined by~     availability and local expertise for each method. The variability of treatment options range~     from anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants~     and hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the~     last therapeutic option due to the high morbidity and mortalityassociated. Various~     endoscopic treatment modalities have been reported. Formalin topic is effective in up to 48%~     of patients with chronic radiation proctitis.~      The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and~     transportation, safe and effective in the treatment of rectal bleeding in patients with~     chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality.~      Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the~     mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency,~     diarrhea and tenesmus in 60% to 75% of cases.~   "
72814|NCT02104258|"~     The purpose of the study is to compare the effect of two rehabilitation protocols with~     different emphasis on eccentric exercises after acute hamstring muscle strain injuries on~     the time to return to sports (RTS) and the rate of re-injuries in male athletes.~      The hypothesis is that the addition of early eccentric hamstring exercises being performed~     at longer muscle-tendon length towards end range of motion alter the outcomes RTS and~     re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.~   "
72823|NCT02104128|"~     This study will investigate the role of dopaminergic neural systems in the symptoms and~     treatment of depression. 40 patients who meet DSM-IV criteria for a diagnosis of depression~     will be compared to a matched sample of healthy controls. The depressed group will receive~     open label treatment with Bupropion MR (150mg bd) for 6 weeks. The control group will~     receive no treatment. All participants will be assessed before treatment, after 2 weeks~     treatment and at 6 weeks treatment. The outcomes assessed will be 1) fMRI estimates of~     neural response to reward to emotionally valenced stimuli (1st and 2nd assessments), 2)~     computer based measures of emotional processing (all assessments) and 3) standardised~     questionnaire measures of depressive symptoms (all assessments). The primary study~     hypothesis is that altering central dopamine using Bupropion will lead to altered neural~     responses to rewarding stimuli in the depressed patients (i.e. comparing fMRI outcomes~     between assessment visits 1 and 2). A secondary hypothesis is that this neural change will~     predict subsequent symptom response to the bupropion (i.e. comparing symptom scores between~     assessment visits 1 and 3), Lastly, the study will test the hypothesis that baseline~     differences in reward circuitry will be particularly associated with symptoms of anhedonia~     (the inability to experience pleasure).~   "
72824|NCT02104115|"~     The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques~     developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic~     gas and volumes in healthy volunteers eating three breads with different amount of gluten~     (none, normal, or high gluten) in three consecutive weeks.~   "
72825|NCT02104102|"~     Check if the Mirror therapy represents an effective method in improving the motor activity~     of the hands of institutionalized elderly.~   "
72826|NCT02104089|"~     The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market~     observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of~     thoracoabdominal aortic aneurysms in routine care.~   "
72827|NCT02104076|"~     The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the~     US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered~     when used in palliation of malignant neoplasms in the biliary tree.~   "
72828|NCT02104063|"~     The presence of metastatic disease in the lymph nodes within the groin is the most important~     factor in predicting the long-term outcome for patients diagnosed with penile cancer.~      In the majority of patients diagnosed with penile cancer obvious abnormalities cannot be~     felt in the groin even though the cancer may have already spread to the lymph nodes in the~     groin. In these patients, a procedure called Dynamic Sentinel Lymph Node Biopsy (DSLB) is~     required to determine if the cancer has spread to the lymph nodes in the groin. In DSLB a~     radioactive substance is injected at the site of the penile cancer and then travels to the~     lymph nodes in the groin which are then biopsied. This procedure requires a general~     anaesthetic and an in-patient hospital stay.~      In approximately 20% of patients with penile cancer obvious abnormalities can be felt in the~     lymph nodes in the groin. However, any abnormality detected may not necessarily be due to~     metastatic disease. In order to confirm if metastatic disease is present in the lymph nodes~     of these patients a biopsy is also required. However in these patients the lymph nodes are~     detected and biopsied using an ultrasound scan rather than by passing a radioactive~     substance into the body.~      MRI-PET is a new procedure which combines conventional MRI (Magnetic Resonance Imaging) and~     PET (Positron Emission Tomography) scans into one scan. MRI - PET scans create very clear~     pictures of internal body structures. MRI-PET is a non-invasive procedure which can be~     performed on an out-patient basis.~      The accuracy of MRI-PET in detecting metastatic penile cancer is not known. The main purpose~     of this study is to establish the effectiveness of MRI-PET compared to DSLB and ultrasound~     guided biopsy in detecting the presence of metastatic disease in the lymph nodes of patients~     with penile cancer. If effective, MRI-PET could replace the invasive procedures currently~     required for detection of metastatic penile cancer.~   "
72829|NCT02104050|"~     The objectives of this trial are to investigate the efficacy and safety of six weeks of~     treatment with OLT1177 Gel in subjects with moderate to severe pain associated with~     osteoarthritis of the knee following cessation of pain therapy.~   "
72830|NCT02104037|"~     The purpose of this study is to investigate transfer of liraglutide from blood to~     cerebrospinal fluid.~   "
72831|NCT02104024|"~     This study is to investigate whether it is possible to use a special type of ultrasound scan~     (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and~     calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We~     currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome,~     involves nuclear medicine and takes 45- 60 minutes to complete.~      We do not routinely image the blood supply to the pancreas post-surgery, despite the most~     common complication post pancreas transplantation being vascular in origin. In an emergency~     a CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner~     and injection of contrast which is harmful to the kidneys.~      CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can~     be carried out at the bed-side, provides instant results and is cheap and safe enough to do~     on a routine basis for all kidney and pancreas transplant recipients. Although the uses of~     CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has~     been compared to other modes of imaging and has been found to be comparable/ beneficial.~     However, it has never been compared to Transcan. We will therefore perform CEUS on our~     kidney transplant recipients and compare the results to Transcan. We will also assess~     whether CEUS is able to visualise the blood supply to the kidney and pancreas and quantify~     the perfusion to the pancreas.~   "
72832|NCT02104011|"~     Treatment of angiomyolipomas is based on invasive techniques such as surgery or~     embolization. Development of anti-angiogenic therapies is a major and growing field of~     research in hypervascularized tumors. Angiomyolipomas have been shown to regress after~     prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of~     secondary effects. We showed recently that beta-blockers were able to induce regression of~     infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases~     of angiomyolipomas the presence of beta2 receptors.~      The aim of the study is to estimate if beta-blockers could induce regression or~     stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.~   "
72833|NCT02103998|"~     The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day~     oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an~     estimated 30% to 21%) the proportion of extremely low gestational age subjects with a~     composite endpoint of cerebral palsy (CP) or a Bayley III Composite Cognitive Score < 85~     at 36 months corrected postnatal age (CA).~   "
72834|NCT02103985|"~     The purpose of this study is to evaluate the effect of food on the bioavailability of a~     single oral dose of JNJ-39823277 and its active metabolites.~   "
72835|NCT02103972|"~     The primary objective of this trial is to assess the efficacy of the consumption of~     heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo~     treatment.~   "
72836|NCT02103959|"~     The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac~     injury associated with coronary angiography in patients with acute coronary syndrome (ACS),~     but excluding ST-elevation myocardial infarction (STEMI) patients. This study will~     specifically examine the ability of CMX-2043 to prevent acute renal injury following~     coronary angiography. The study will also examine the ability of CMX 2043 for prevention of~     periprocedural cardiac injury. Information will be obtained relating to the ability of CMX~     2043 for prevention of major adverse cardiac and renal events following the procedure.~     Additional information will be obtained in this study to evaluate safety of the drug. Dose~     and regimen information will also be obtained for future clinical studies of CMX-2043.~   "
72837|NCT02103946|"~     ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus~     anterior plane block, for preventing postoperative pain after breast surgery for cancer.~     This block will be compared with the well-established paravertebral block.~   "
72838|NCT02103933|"~     The purpose of this study is to assess the level of knowledge of surgery for women who~     underwent hysterectomy~   "
72839|NCT02103920|"~     The purpose of this study is to determine the expression of molecules involved in the~     glycine/serine pathway using immunohistochemistry in solid tumors. Archived~     paraffin-embedded pathological specimens from the Department of Pathology, NUH will be~     obtained. Tissue microarray (TMA) is a high-throughput method of analysing large numbers of~     formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the~     expression of molecules of putative relevance to the glycine/serine pathway, (such as PSPH,~     PSAT1, SHMT1, and GLDC), TMA technology will be utilised as previously reported~     (Kristiansen, Zhang, Soong). Tissue arrays will be constructed from solid tumors including~     cancers of the colon/ rectum, lung, breast, cervix, ovary, endometrium, fallopian tube,~     prostate, kidney, testis, stomach, liver, brain and lymphoma. One hundred cases of each~     tumor type (subject to availability) will be stained using immunohistochemistry. Patient~     Identifiers will not be collected. Societal benefit in terms of knowledge gained to improve~     understanding of cancer. No direct risk to subjects as this is a retrospective study of~     archived pathological tumour samples.~   "
72840|NCT02103907|"~     There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to~     healthy older adults. Balance is a key element of function that allows individuals to~     maintain posture and respond to perturbations, and poor balance control, a risk factor for~     falls, has been noted in those with knee OA. There is a lack of research guiding treatment~     for balance deficits in knee OA, with interventions aimed at improving balance deficits in~     those with knee OA having mixed results. Targeted dynamic balance interventions in other~     patient populations have been shown to significantly improve dynamic balance control and~     physical function. If results similar to such populations can be achieved, such a program~     may produce a significant reduction in functional disability in the knee OA population and~     improve quality of life. The purpose of this study is to examine the effect of a 10-week~     targeted dynamic balance intervention on dynamic balance and physical function in people~     with knee OA. This will be a randomized controlled trial (RCT).~   "
72841|NCT02103894|"~     The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau~     pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy,~     including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy~     (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age-~     and gender-matched healthy subjects.~   "
72842|NCT02103881|"~     This research study is being done to find out if one of two drugs, ketamine or haloperidol,~     is better for treating agitation. Agitation is a state of extreme emotional disturbance~     where patients can become physically aggressive or violent, endangering themselves and those~     who are caring for them. Often chemical substances or severe mental illness is involved in~     this level of agitation. Specifically, the investigators are interested in studying~     agitation that is treated in the prehospital setting by paramedics. This study's hypothesis~     is that ketamine is superior to haloperidol for treatment of agitation in the prehospital~     environment.~   "
72843|NCT02103868|"~     Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be~     divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation~     intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control~     arm. At the end of 12 months of intervention quit rates will be compared.~   "
72844|NCT02103855|"~     Kidney damage is a major complication of current antirejection medicines used in~     transplantation. An increasing number of brittle diabetics are successfully receiving a~     pancreas transplant. One of the challenges following pancreas transplant is that a patient~     can develop kidney damage from one of their antirejection medicines, tacrolimus. The~     objective of this study is to substitute a new antirejection medicine which does not cause~     kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus~     related kidney damage to slow the progression of kidney disease.~   "
72845|NCT02103842|"~     The purpose of this study is to determine how omega-3 fatty acids influence muscle protein~     metabolism and mitochondrial physiology in the context of human aging.~   "
72846|NCT02103829|"~     Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on~     their own. The purpose of this study is to determine whether very brief suggestions provided~     online are comparatively more effective than others in increasing motivation to quit~     immediately after the suggestions are implemented and actual quit rates one month later.~      There are no costs associated with participating in this study and participants will not be~     compensated for their participation.~      To join the study paste the following link into your browser:~      https://www.i4health-pau.org/quit-smoking-on-your-own~      The entire study takes place online on an automated website.~   "
72847|NCT02103816|"~     The purpose of this study to evaluate the SmartLipo Triplex laser system along with the~     SideLaze800 hand piece in the treatment of Acne Scars.~   "
72848|NCT02103803|"~     This proposal aims to describe the oculometric features present during King-Devick (K-D)~     testing for subjects who experienced sports-related concussion. The investigators aim to~     better describe the underlying oculomotor anomalies present in this cohort that lead to~     increased K-D test time. Understanding these anomalies will allow for better understanding~     of the effects of sports-related concussion and may provide a rapid and reliable metric for~     diagnosing concussion as well as monitoring long-term recovery.~   "
72849|NCT02103790|"~     Neuromuscular diseases are frequently associated with respiratory failure, which requires~     Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an~     hospitalization of several days. This hospitalization is problematic because of availability~     of beds, logistical difficulties for the patient and estrangement from the usual~     environment.~      For this reasons, the NIV installation at home could be an interesting alternative for both~     the patient and the medical staff.~      The aim of this pilot study is to test the feasibility of NIV installation at home, using~     telemedicine as a remote monitoring tool, and to assess its impact on the ventilation~     compliance.~   "
72850|NCT02103777|"~     The optimum caffeine dose for apnea of prematurity has not been well investigated so the~     objective of the study is to compare high versus low dose of caffeine citrate to facilitate~     successful extubation in mechanically ventilated preterm infants.~   "
72851|NCT02103764|"~     The objectives of the present study is to determine the effectiveness of cyclic desogestrel~     (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory~     dysfunctional uterine bleeding (DUB) in the following aspects:~        1. Endometrial histopathology changes~        2. Menstrual cycle control.~   "
72852|NCT02103751|"~     The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially~     Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in~     smokers and non smokers.~   "
72853|NCT02103738|"~     This is an observational study to will evaluate and compare two Ranibizumab treatment~     regimens (Standard of care) in patients with neovascular (wet) age-related macular~     degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The~     results will be used to generate further recommendations on the timing of treatment~     administration for patients with neovascular (wet) age-related macular degeneration (wAMD).~     In this context, the study will use the anatomical imaging (for example, optical coherence~     tomography [OCT]) to evaluate wAMD disease activity impacted by the recurrence of disease~     instability and for decision making in the treatment decision algorithm.~   "
72854|NCT02103725|"~     The purpose of this study is to validate a left-right design with respect to detecting a~     difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle~     in adults with mild to moderate atopic dermatitis~   "
72855|NCT02103712|"~     Hypospadias is a common congenital abnormality of the penis which affects approximately 1~     boy in 250. The opening of the urethra is located on the undersurface of the penis rather~     than the tip,the foreskin is deficient and there is curvature of the penile shaft in more~     severe cases. Although the most commonly practised corrective operation ( TIP procedure)~     gives generally good results, recently published evidence points to a possible long term~     risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will~     combine clinical assessment with non invasive measurements of urinary flow to assess the~     functional outcome of a large series of patients who have undergone hypospadias surgery .~     The study is primarily designed to answer this question : does a modification of the~     standard operation which incorporates a skin graft into the reconstructed urethra lead to~     improved urinary flow and a decreased risk of stenosis? This has not been previously studied~     . The findings of our study could make an important contribution to improvements in the~     surgical treatment of boys born with hypospadias.~   "
72856|NCT02103699|"~     The purpose of this study is to evaluate the effectiveness of a simeprevir-containing~     hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).~   "
72857|NCT02103686|"~     The purpose of this study is to:~        1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to~          immediate release capsule(150mg * 2).~        2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained~          release tablet.~   "
72858|NCT02103673|"~     The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral~     and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA~     activation is critical for learning and memory. Individuals with Alzheimer's disease (AD)~     have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is~     a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated~     randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2)~     placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy~     than placebo for cognitive function and clinical symptoms in patients with BPSD.~   "
72859|NCT02103660|"~     The purpose of this study is to determine the acceptability of randomization to~     contraceptive options and estimate the effect of progestin contraception on HIV genital~     shedding and inflammatory/immune perturbations in women who may or may not be on~     antiretroviral therapy, as well as in HIV-uninfected women controls. It is hypothesized that~     progestin-containing contraception will lead to inflammatory changes that may affect the~     local immune activity, influencing HIV acquisition or transmissibility risk.~   "
72860|NCT02103647|"~     The purpose of this study is to compare the pharmacokinetics profiles of pregabalin~     sustained release tablet (300mg) to immediate release capsule(150mg * 2) while multiple~     dosing.~   "
72861|NCT02103634|"~     This study will look at two new technologies being developed for measuring cancer in bones.~     One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal~     body substance. The amount that patients will receive has been shown to be very safe. One~     study of over 400 patients showed no adverse reactions after receiving the recommended~     dosage.~      NaF (known as a radiotracer) is taken up into the bones under a normal process and~     researchers can measure the amount within patient's bones through an imaging system called a~     Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines~     aspects of both a PET study as part of the regular standard of care and an MRI study. The~     belief is that the combination of these two studies will be better than either study~     alone.People who have enrolled in this study will receive their clinically requested PET/CT~     scan as part of their normal diagnostic care and will follow all the said recommendations~     for this study such as not being pregnant, having fasted overnight, etc. Subjects will~     return within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up~     to 120 minutes depending on the MRI sequences acquired. Imaging for the PET portion of the~     study will take approximately 20-30 minutes with the rest of the time devoted to MRI~     sequences.~   "
72862|NCT02103621|"~     This study will address questions of fundamental clinical significance including: (1)~     whether OCD patients maintained on long term SRIs can be discontinued without symptom~     exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce~     worsening following discontinuation compared to Taper and Monitoring, and (3) whether~     predictors of successful SRI discontinuation can be identified.~   "
72863|NCT02103608|"~     This is a clinical study to determine the efficacy and safety of the Glide, hair removal~     photo-depilation device, for removing facial hairs. During the first stage, the subjects~     will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency~     will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.~   "
72864|NCT02103595|"~     German Multi-centered, randomized, crossover study in diabetic patients evaluating two~     infusion sets under real life conditions at home. Subjects will be randomized to use one of~     the infusion set devices during the first period of 4 weeks, and be switched to the other~     infusion set for the second period of 4 weeks.~   "
72865|NCT02103582|"~     The Quit & Fit intervention will be designed as a 12-week study to promote smoking~     cessation, increase physical activity levels, and reduce weight gain through regular~     exercise and healthy nutrition for African American Women smokers.~      Patients will be assigned to the fitness intervention group or control groups by a computer.~   "
72866|NCT02103569|"~     The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose~     combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive~     agent.~   "
72867|NCT02103556|"~     The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the~     treatment of constipation of patients undergoing hemodialysis.~   "
72868|NCT02103543|"~     Patients with back pain with spinal stenosis of the lower back will be asked to volunteer~     for this research study. These patients don't need immediate surgery for this problem.~     Treatment of this kind of back pain with spinal stenosis usually includes physical therapy~     exercises and steroid injections. Both treatments are usually helpful in patients with back~     pain with spinal stenosis. However, physicians and other healthcare providers don't know~     which treatment is better to give first. The purpose of this research is to answer that~     question. Patients enrolled in this study will receive both treatments: physical therapy~     (PT) and a steroid injection (shot). However, patients may get the shot first followed by~     PT, or they may have PT first, followed by the shot. Their time in this study will last up~     to 6 months, and there will be five outcome measurements (via visits or telephone). All~     study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators~     hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized~     using a randomization computer program.~   "
72869|NCT02103530|"~     The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early~     response assessment of induction chemotherapy in acute myeloid leukemia patients.~   "
72870|NCT02103517|"~     The purpose of this study is to determine whether omega-3 fatty acids supplementation are~     effective in the improvement of suboptimal health status and cardiovascular risk.~   "
72871|NCT02103504|"~     The DePuy Attune knee system incorporates several key features aimed at improving kinematics~     of the knee joint, range of motion, and smoothness of use compared to existing total knee~     replacement technologies. As this is a newly approved medical device, clinical testing in~     patients using high precision diagnostics is important to evaluate the stability of implant~     fixation and in vivo function. We propose a multi-centre consecutive series study examining~     the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total~     knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will~     be utilized to identify the micromotion of the tibial tray with respect to the surrounding~     bone. Health status and functional outcome measures will be recorded to quantify functional~     status of subjects before surgery and at follow-up intervals.~   "
72872|NCT02103491|"~     Background: Ultradistance athletes frequently consume salt supplements during competitions~     to compensate the loss of electrolytes by sweating. The aim of this study was to investigate~     the effectiveness of oral salt supplementation to improve exercise performance during a~     half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for~     age, anthropometric data and training status and randomly placed into the salt group (113~     mmol Na+ and 112 mmol Cl-) or the control group (cellulose). The experimental treatments~     were provided in unidentifiable capsules and were ingested before and during the race.~     Participants competed in a real half-ironman triathlon and race time was measured by means~     of chip timing. Pre and post-race, body mass, maximal force during a whole-body isometric~     strength test, maximal height during a countermovement jump, and blood samples were~     obtained. Sweat samples were obtained during the running section.~   "
72873|NCT02103478|"~     This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well~     as determine the dose for the study's second stage. In the second stage the selected dose~     will be confirmed and evaluated for clinical activity, including response rate.~   "
72874|NCT02103465|"~     This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine,~     as so far no data on elderly population is available.~      Primary objective: To assess efficacy and safety of rotigotine in patients with late onset~     Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.~      Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset~     Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms :~     sleep quality; depression; cognitive function.~      Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at~     least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12~     months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom~     the caring physician is uncertain on whether or not to start treatment.~      Outcome Measurement: Percentage of Responders to treatment in motor (part III) and~     Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating~     Scale (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in~     relation to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to~     treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.~      Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset~     Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.~      One group will be treated with rotigotine and one group will be treated with placebo, for 12~     weeks after titration.~   "
72877|NCT02103426|"~     The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA]~     vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine~     whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers,~     CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by~     the vaccine after repeated ASP0113 IM injection.~   "
72878|NCT02103413|"~     Although ERCP is almost always successful in patients with malignant biliary obstruction,~     selective biliary cannulation fails in some cases and conventional ERCP may not be possible~     in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy~     (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases,~     percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD~     had various complications and the presence of an external drainage catheter would also have~     a cosmetic problem related to the external drainage and an adverse impact on quality of life~     (QOL) of terminally ill patients.~      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case~     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and~     effective alternative in patients with failed conventional ERCP stenting. The potential~     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for~     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot~     be internalized, thus significantly improving the QOL of terminally ill patients, and~     possibly lower morbidity than PTBD or surgery.~      Up to date, only a few case series of EUS-BD with small numbers of patients have been~     published, and known the feasibility and safety in terms of the incidence of~     procedure-related clinical outcomes.10-21 There has been no comparative study between the~     outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.~      The researchers investigated the technical success of EUS-BD and PTBD in patients with~     malignant biliary obstruction after failed conventional ERCP as a prospective randomized~     comparative study in multicenters. Secondary endpoints were the cost-effectiveness and~     complications rates between EUS-BD and PTBD.~   "
72879|NCT02103400|"~     Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional~     capacity, peripheral muscle strength and quality of life. Despite the high incidence and~     severity has not yet been demonstrated whether a physical training program can change these~     outcomes. Objectives: To evaluate the effects of an exercise training program in patients~     hospitalized for CAP, to compare this effects with traditional physical therapy and assess~     whether the inflammatory markers correlate with the functional status of the patient and~     type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients~     hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will~     be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk~     test, Glittre test, measurement of peripheral muscle strength, spirometry, and the~     application of quality of life questionnaire Shor Form 36 will be held. The measurement of~     inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held.~     Patients will be randomized into two groups: one will perform a program of physical training~     (stretching, active resistance exercises and aerobic exercises) and the other group held the~     traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight~     days. On the tenth day the same assessment will be carried out initially described.~   "
72880|NCT02103387|"~     To test the effects of 2 different 5-wk stress management interventions (cognitive~     behavioral training or relaxation training) vs. a time-matched 5-wk health education~     condition on psychosocial adaptation and physiological adaptation in women being treated for~     breast cancer. Participants assigned to either of the stress management conditions will show~     improved psychosocial adaptation and physiological adaptation compared to those assigned to~     the health education condition.~   "
72881|NCT02103374|"~     Design studies of nebulization in COPD does not respond adequately to the clinically~     relevant question: the intervention of administering nebulized bronchodilators at home it is~     likely to make a profit, compared to the standard optimized treatment as defined by the~     recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50%~     of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value~     FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of~     life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and~     steroids ...).~   "
72882|NCT02103361|"~     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and~     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic~     effect of these medications and to follow live born infants for one year after birth. With~     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be~     relevant to a medication exposure during pregnancy, and these include both easily~     recognizable defects which are visible at birth, as well as more subtle or delayed defects~     that may not be readily identifiable without special expertise and observation beyond the~     newborn period.~   "
72883|NCT02103348|"~     This study is designed to characterize subjects in terms of their sputum phenotype. The~     purpose of this study is to learn more about the impact of having abnormally elastic sputum~     on asthma severity by comparing subjects with severe as well as mild/moderate asthma to~     healthy controls. The characterization will include medical history, pulmonary function~     testing, imaging of the lungs and biospecimen collection.~   "
72884|NCT02103335|"~     This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of~     relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:~        -  Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory~          drug) that has been approved by the United States (US) Food and Drug Administration~          (FDA) for the treatment of multiple myeloma.~        -  Marizomib is an investigational drug being developed by Triphase that is being studied~          for the treatment of multiple myeloma. Investigational drugs are drugs that have not~          yet been approved by health authorities, such as the FDA, for general use but have been~          approved for use in specific clinical studies. Marizomib inhibits a cellular machine~          called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome~          inhibitors have been shown to be effective in the treatment of multiple myeloma.~        -  Dexamethasone is a corticosteroid drug that affects the immune system (an~          immunomodulatory drug) that has been approved by the FDA for the treatment of multiple~          myeloma.~      This is the first study to evaluate the three-drug combination of pomalidomide (POM),~     marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination~     with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory~     multiple myeloma.~      The primary objective of this study is to determine the best drug dosing levels for this~     three-drug combination, including the highest safe doses and/or the recommended doses for~     future clinical studies of this drug combination. The secondary purposes of this study are~     to determine the safety of this drug combination and its effectiveness in treating relapsed~     or refractory multiple myeloma. The study will include examination of levels of all three~     drugs in the blood during various time points during treatment.~   "
72885|NCT02103322|"~     To characterize pharmacokinetic profile of test product compared to that of the~     corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid~     Leukemia & Gastrointestinal Stromal Tumor under Fed Conditions.~   "
72886|NCT02103309|"~     The purpose of this study is to evaluate lens centration and subjective impressions of~     DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in~     ball sports players.~   "
72887|NCT02103296|"~     The goal of this protocol is to establish a randomized clinical trial comparing the use of~     cord blood vs. infant blood with the primary outcome of comparing both the absolute~     hemoglobin concentration and the percent change in hemoglobin concentration from baseline~     around 24 hours of life.~   "
72889|NCT02103270|"~     Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed~     after the initial 3 month avoidance period~      Secondary Objectives:~        -  Identify the basic immune mechanisms which can explain the differences in the effects~          of OIT in desensitized vs. tolerant individuals.~        -  Determine whether immune monitoring measurements reflecting underlying mechanisms~          during OIT can be used to predict responses to OIT in individual subjects and,~          ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.~   "
72890|NCT02103257|"~     This randomised, controlled, multicentre trial is designed to assess the efficacy and safety~     of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in~     stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.~   "
72891|NCT02103244|"~     An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been~     developed, that accounts for high BMI, low serum creatinine values and maximal calculated~     renal function. The hypothesis is that this new dosing algorithm provides a more accurate~     and safe dose than dosing according to the old standard of care.~   "
72892|NCT02103231|"~     The purpose of this study is to understand more about why young people who were born~     prematurely may have increased risk of high blood pressure and lower cardiovascular exercise~     capacity.~   "
72893|NCT02103218|"~     African American adolescent females are more likely to have sex at an early age, to have~     older sex partners that have had multiple sexual experiences, and are less likely to use a~     condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky~     sex behaviors of young African American women. African American girls at the greatest risk~     for contracting HIV are the ones that report that their partners could convince them to have~     sex and report trouble communicating their wishes related to sex. Thus far no intervention~     has addressed the disparate rate of HIV infection in young African American girls. This~     study is unique in promoting increases in racial pride as a component of empowerment to help~     African American girls self-protect against HIV. The study has the potential to empower~     young African American girls to delay sex initiation or reduce risky sex behaviors and thus~     reduce their risk of contracting HIV.~   "
72894|NCT02103205|"~     Breast milk is the gold standard of early infant nutrition and breastfed infants have~     advantages in several short and long term outcomes compared to those formula-fed.~      The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant~     formula. The general hypothesis is that bovine lactoferrin reduces some of the previously~     observed differences between formula-fed and breast-fed infants with regard to health and~     development. The main outcome studied is the effect on immune function. The second aim is to~     study the effects of lower iron concentration in infant formula and to test the hypothesis~     that iron can be lowered without negative effects on health and development. The main~     outcome studied here is iron status. Other outcomes in this trial are microbiota~     composition, metabolomics, growth, body composition and cognitive development.~      To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron~     (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test~     the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher~     iron concentration (8 mg/L). Group allocation for all formula-fed infants will be~     double-blind randomized. Additionally, breast-fed infants will be recruited and used as a~     reference group (gold standard).~   "
72895|NCT02103192|"~     The objective of this study is to assess the effects of nutrient-fortified beverage on~     mental energy in healthy human subjects.~   "
72896|NCT02103179|"~     The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in~     ECC growth, proliferation and apoptosis.~   "
72897|NCT02103166|"~     The purpose of this study is to determine whether hyoscine bromide decreases the duration of~     the active phase of labor.~   "
72898|NCT02103153|"~     The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of~     unwanted tattoos~   "
72899|NCT02103140|"~     Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast~     cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the~     MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations~     for breast cancer prevention are now focused on maintaining a healthy weight via increased~     physical activity levels, and losing weight if overweight or obese.~      This pilot project compares two exercise interventions: a supervised facility-based and a~     home-based exercise intervention to a control group in African-American women with metabolic~     syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to~     assess the impact of the exercise interventions on biomarkers related to obesity,~     insulin-related pathways, inflammation, hormones, and micro-RNAs.~      The specific aim of the proposed study is to compare the impact of a supervised~     facility-based and a home-based exercise intervention on obesity, metabolic syndrome and~     known breast cancer biomarkers in postmenopausal African-American women with metabolic~     syndrome who are at increased risk of breast cancer.~   "
72900|NCT02103127|"~     The purpose of this study is to assess treatment of facial acne scars using the 755nm~     Alexandrite Laser with lens arrays.~   "
72901|NCT02103114|"~     The purpose of this study is to test whether the administration of ATIII during the~     intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB)~     and an attenuation of the activation of the coagulation cascade, as represented by a~     decrease in fibrin degradation products. The investigators believe this benefit would extend~     into the post-operative period resulting in a decreased incidence of thrombosis generation,~     as represented by a decrease in fibrin degradation products in the ICU period.~   "
72910|NCT02102997|"~     The DTS.DE registry is an initiative for the collection of high quality process and~     historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was~     designed as a national, non- randomized, prospective, multicenter registry without a~     comparison group.~      The responsible Steering Committee is of the opinion that the Combo stent qualifies for~     further documentation of treatment results in the form of a German registry, based the CE~     certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific~     investigation in the context of the REMEDEE study program, as well as company independent~     externally initiated studies with the COMBO Dual Therapy Stent.~      It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in~     the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed~     after 6 weeks and 12 months.~   "
72902|NCT02103101|"~     Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent~     monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now~     available on the market. These NOACs, like all anticoagulant drugs, continue to be~     associated with an increased risk of bleeding. In addition, the lack of antidote and the~     absence of valid data regarding biological monitoring can pose problems in case of overdose~     or when emergency surgery is required. Studies investigating the pharmacokinetic properties~     of rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high~     variability between individuals, with coefficients of variation of up to 60% for some~     pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation~     between plasma concentrations of NOAC and bleeding risk has been clearly established in~     clinical trials.~      Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp~     activity can be affected by pharmacological inducing or inhibiting agents. This can lead to~     a significant change in the pharmacokinetics of NOACs, with a decrease or increase~     (respectively) in the level of intestinal absorption, leading to respectively reduced or~     increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of~     Pgp, presenting in particular a lower level of activity than the non-mutated protein. We~     hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could~     influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently,~     impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic~     risk of patients treated with these molecules.~      The main objective of this study is to study the relation between polymorphisms of the ABCB1~     gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a~     hemorrhagic or thromboembolic complication occurring under NOAC therapy.~      Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the~     various hemorrhagic risk factors, and to compare the frequency of the polymorphism in~     patients from the study population vs the general population.~   "
72903|NCT02103088|"~     Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of~     the prostate gland (prostatectomy) which may be associated with immediate and long lasting~     erectile dysfunction and decline in urinary function. Besides these physical late effects~     patients operated for PC have a twofold increased risk for depression up to ten years after~     the diagnosis. To reduce these late effects affecting both patient and partner the~     investigators have developed a sexual and urological intervention (PROCAN). The intervention~     is based on epidemiological data, evidence from previous clinical trials, a feasibility~     study and qualitative explorations among PC patients and partners. The investigators hereby~     suggest the conduction of a randomized controlled trial to test the effect of the PROCAN~     intervention on urological and sexual dysfunction, couples adjustment and quality of life.~     Results of the proposed trial may provide clinicians and decision makers with the evidence~     needed to optimize rehabilitation after PC.~   "
72904|NCT02103075|"~     Spinocerebellar ataxia (SCA) is a hereditary disorder with movement incoordination. The~     ataxia performed low intra-cortical facilitation mainly due to the degenerative cerebellum.~     Noninvasive sensory stimulations such as peripheral electrical stimulation were reported to~     modulate the excitability of the motor excitability. Neuromuscular electrical stimulation~     (NMES) was proposed as a neuromodulation tool for the aberrant motor excitability on the~     SCA. This study aims to investigate the effect of NMES on the motor excitability in the SCA,~     and the differentiation on the central or peripheral motor excitability changed by the NMES.~   "
72905|NCT02103062|"~     The purpose of this study is to evaluate the safety and efficacy of Abraxane~     (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects~     will be placed into two separate cohorts based on their RAS mutation status.~   "
72906|NCT02103049|"~     In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic~     patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is~     treated with statins in low doses only as high doses can lead to rhabdomyolysis and are~     therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used.~     The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney~     transplant patients lowers LDL cholesterol for additional 10 per cent.~   "
72907|NCT02103036|"~     The purpose of the study is determine whether the Core Stability Exercise is more effective~     than the traditional Back School for low back pain (LBP) in women.~   "
72908|NCT02103023|"~     Influenza poses a heavy burden to our health service. The WHO estimates that seasonal~     influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including~     intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity.~     Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the~     treatment of DNA virus infection, have been shown to improve vaccine immunogenicity against~     influenza virus in mouse model. The objective of this prospective double-blind randomized~     controlled trial is to evaluate the effect and safety of topical treatment with imiquimod~     immediately before intradermal influenza vaccination in healthy young adults.~   "
72909|NCT02103010|"~     Radiotherapy is an integral component of the current multimodality treatment approach in~     locally advanced head and neck cancer (HNC). There is growing evidence that more aggressive~     treatment regimens improve tumour control and survival. However, intensified treatment is at~     the expense of increased toxicity, in particular severe acute mucositis. In addition and of~     increasing importance, late and irreversible treatment-related side effects, including~     xerostomia and swallowing dysfunction, occur in a considerable proportion of patients and~     negatively affect quality of life.~      High-risk human papilloma virus (HPV), specifically HPV type-16, is implicated as the~     causative factor in a proportion of HNC, especially those of the oropharynx. HPV-related~     cancers respond well to chemoradiotherapy compared to HNC related to tobacco and alcohol.~     Furthermore, the incidence of HPV-related oropharyngeal cancer is rising in Western~     countries. Given the significant toxicity associated with concurrent chemoradiotherapy,~     subsets of patients could be managed differently.~      The first objective of the project is to develop predictive models for radiation-induced~     dysphagia and xerostomia in HNC patients. Clinical characteristics, treatment parameters,~     dose-volume effects on healthy tissues and whole-genome genetic data will be considered. The~     second objective of the project is to study the prognostic value of HPV status together with~     a panel of tumour biomarkers in oropharyngeal cancer patients. The overall aim of the~     project is to stratify patients according to the risks (side-effects) and benefits~     (survival) of cancer treatment using the developed risk models. Clustering patients into~     different risk categories may aid treatment decision making reducing therapy toxicity~     without compromising survival.~   "
72911|NCT02102984|"~     Patency duration of covered metal stents as compared with uncovered metal stents in the~     management of malignant strictures of the extra-hepatic biliary tree.~   "
72912|NCT02102971|"~     The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role~     in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve~     hepatic function of patients with liver diseases.~   "
72913|NCT02102958|"~     Because people who have both diabetes and visual impairment have high risk for foot~     problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes~     self-management education (DSME) is to teach them to seek sighted assistance for regular~     foot examination, yet clinical experience suggests that this advice is seldom heeded. One~     possible solution is to teach use of the nonvisual senses of touch and smell for a~     systematic, thorough foot self-examination. The purpose of this pilot study was to compare~     the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care~     (examination of the visually impaired person's feet by a sighted family member or friend).~   "
72914|NCT02102945|"~     In the present pilot study, the investigators propose to determine if performing CT~     perfusion scans in post-cardiac arrest patients in coma will help prognosticate the outcome~     in these patients.~   "
72915|NCT02102932|"~     The aim of the trial is to assess the relative bioavailability of fixed dose combination~     tablets of Empagliflozin and metformin compared to the administration of single tablets~     (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose~     combination tablet is expected to significantly enhance patient's compliance with~     antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic~     patients.~   "
72916|NCT02102919|"~     The goal of this randomized controlled study was to examine the effects of a 8 weeks~     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual~     virtual games [VG]) in the skilling up phase on physical performance and strength in elderly~     in need of care population.~   "
72917|NCT02102906|"~     Functional motor disorders, also called motor conversion disorder, are common reasons for~     attendance at neurology outpatient clinics. Patients with functional motor disorders are~     more common than patients with multiple sclerosis and have similar levels of disability but~     more psychological morbidity.~      There is limited evidence for effective treatments in functional motor disorders. A small~     number of studies of transcranial magnetic stimulation (TMS), a painless method of cortical~     stimulation, have reported improvement in functional weakness after this treatment including~     in patients with symptoms of several years duration. The Investigators intend to trial TMS~     in a group of 40 patients with functional motor disorder, randomising patients to immediate~     or delayed treatment and therefore comparing a single session of TMS with routine clinical~     care. The Investigators will also ask patients to undergo tests of attentional focus in a~     cognitive neuroscience laboratory - these experiments will be analysed separately from TMS~     trial data.~   "
72918|NCT02102893|"~     Neuroendocrine tumors (NETs) are neoplasms originating from neuroendocrine cells located~     throughout the body. They secret various peptides and cause various symptoms (carcinoid~     syndrome) or not. The incidence of NETs was not well-known till recently when Yao et al. and~     Hausa et al. published their surveys of NETs using data from the US Surveillance,~     Epidemiology, and End Results (SEER) program and from the Norwegian Registry of Cancer~     (NRC). The incidence of NETs in Taiwan by using the Taiwan Cancer Registry (TCR) data was~     increased from 0.3 to 1.51 per 100,000 from 1996 to 2008. The increased incidence for NET~     worldwide probably was partially due to the awareness and improvement of diagnostic~     technology. Compared with the incidence in western countries, the incidence of NET is much~     lower in Taiwan. And the incidence of NETs in Asian Pacific Islanders was also lower than~     the whites and blacks in US. Gastroenteral-pancreatic NETs (GEP-NETs), accounting for half~     to two thirds of all NETs, is the most common site of NETs. As the progress in the~     understanding of pathophysiology for GEP-NET, there are two novel targeted agents shown to~     be effective for the treatment of GEP-NET. Meanwhile, response to mTOR inhibitor was better~     for Asian than Caucasian in the phase III study using everolimus for advanced pancreatic~     NETs. These information suggests that there is racial difference for either genetic or~     environmental risk factors and these factors result in different incidence and/or clinical~     outcome. Currently, there is limited data for thorough epidemiologic study in Taiwan. The~     aim of this study is to collect clinical information for GEP-NET, and survey the prognostic~     factors for GEP-NET in Taiwan. We suppose that this epidemiologic study would provide a~     database potentially to improve the diagnosis, and treatment of GEP-NET. This study plans to~     include 600 GEP-NET patients. NET patients diagnosed after 2011.1.1 is included in this~     study.~      Furthermore, we will provide the check of immunohistochemical staining for the tumor tissue~     of GEP-NET patients, including the functioning status (insulinoma, glucagonoma, gastrinoma,~     VIPoma) and the degree of differentiation, the expression of SSTR2 or SSTR5 and the check of~     possible primary site for unknown primary NET patients. This examination will provide more~     accurate diagnosis for the patients and further treatment suggestion for the patients.~   "
72919|NCT02102880|"~     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic~     component. Given that it is known that impaired regulation of choroidal vascular tone is~     present in patients with AMD, the current study seeks to investigate whether genetic~     polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow~     regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be~     included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood~     flow during isometric exercise. In addition, flicker induced vasodilatation will be studied~     and retinal vessel calibers will assessed, as well as retinal thickness and macular pigment~     optical density.~   "
72920|NCT02102867|"~     The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for~     evaluation of similar elements of rectal compartment use; (b) develop these scales using 3~     distinct semi-solid formulations that represent a range of physicochemical and rheological~     properties of microbicides that are currently being designed for dual compartment use; and~     (c) develop novel USPE instruments to capture the experience of product use in the context~     of receptive anal intercourse (RAI) in both male and female cohorts.~   "
72921|NCT02102854|"~     Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection~     following kidney transplantation and is routinely administered as a series of 5-7~     consecutive daily doses via central intravenous catheter.Single large-doses of rATG have~     been shown to have equivalent safety and efficacy profile compared to the standard daily~     protocol when used as an induction agent but there are no reported experiences of its use~     for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG~     administration including correlation to length of hospital stay and hospital costs.~   "
72922|NCT02102841|"~     The aim of this study is to investigate the mechanisms behind the immune dysfunction that~     occurs in atopic eczema (or atopic dermatitis).~   "
72923|NCT02102828|"~     The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent~     sequential compression with cold therapy and is designed for single patient use in the home.~     Additionally, it can track patient compliance. This study will examine if there is a~     difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total~     knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a~     cooling device/MCD system.~   "
72924|NCT02102815|"~     To determine efficacy of preoperative IV dexamethasone for postoperative pain control after~     TKA.~   "
72925|NCT02102802|"~     This study measures biological and psychological processes that might help researchers to~     better understand what is taking place during low or medium dose and full dose MDMA-assisted~     psychotherapy treatment in people with PTSD. Heart rate variability (HRV) will be measured~     up to three times; before and once or twice after receiving MDMA-assisted psychotherapy.~     Brain activity will be measured before and after MDMA-assisted psychotherapy in response to~     personalized trauma-related scripts. Participants will complete a measure of self-compassion~     at baseline and two months after a final experimental treatment session. Therapy techniques~     observed during recorded treatment sessions will be classified using a standardized clinical~     measure.~   "
72926|NCT02102789|"~     The primary objective of this study is to determine whether systemic chemotherapy combined~     with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete~     resection rate (R0) and improve the overall survival in patients with initially unresectable~     colorectal liver metastasis.~   "
72927|NCT02102776|"~     The purpose of this randomized multi-center clinical trial is to compare the efficacy and~     safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and~     Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also~     evaluate particular risk factors related to pterygium recurrence.~   "
72928|NCT02102763|"~     The purpose of the GRECO study were to: a) to provide national data on overweight and~     obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years~     old, b) to identify those socio-economic, demographic factors, as well as dietary and~     physical activity habits and familial characteristics that are associated with childhood and~     preadolescent overweight and obesity, c) to identify lifestyle and dietary patterns that are~     associated with elevated blood pressure levels and dietary sodium intake.~   "
72929|NCT02102750|"~     The purpose of the study is to examine how preservative free tafluprost ophthalmic solution~     (0.0015%) is distributed in blood circulation after ocular administration in children who~     have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general~     will also be assessed.~   "
72930|NCT02102737|"~     Insulin resistance is closely associated with apparition of type 2 diabetes mellitus; it is~     an independent risk factor and predicts future cardiovascular events.~      Hyperinsulinemic euglycemic clamp is a validated method to assessment of insulin resistance~     and It is also the gold standard technique. However, the complexity and length of this~     technique render it unsuitable for routine clinical use.~      In this study, the investigators use a new technique to provide precise, objective, fast and~     automated quantification of insulin resistance with camera SPECT.~      They compare the results with those of the measurement of hyperinsulinemic euglycemic clamp~     in population with or without insulin resistance.~      The proposed study is to validate this new non-invasive imaging technique for evaluation of~     insulin resistance in patients with or without insulin resistance with a comparison with~     hyperinsulinemic euglycemic clamp.~   "
72931|NCT02102724|"~     HIV infection is associated with premature aging of the immune system. It is believe that~     the persistent inflammation that accompanies HIV infection is a major contributor to~     premature immune aging. Fish oil has well-documented anti-inflammatory properties. In this~     randomized, clinical trial, we're testing whether a 12-week course of fish oil~     supplementation will reverse premature aging in HIV-infected African American older adults.~   "
72932|NCT02102711|"~     Vitamin A is essential for optimal growth, and development. In the newborn, especially if~     preterm, it is necessary for the cellular differentiation, for the health of the anterior~     eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis.~     Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but~     very low (<1500g birth weight) and extremely low (<1000g birth weight) preterm infants are~     born with low body stores of vitamin A and are at high risk of vitamin A deficiency.~     Nevertheless, optimal vitamin A supplementation for these infants is not clearly defined,~     despite evidence of benefit of an early supplementation.~      Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease~     marked by respiratory compromise associated with high mortality and severe long-term~     morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that~     may be related to less rhodopsin quantity which seem dependent on vitamin A concentration.~     Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral~     administration as drops is available resulting particularly convenient avoiding the pain~     associated with repetitive intramuscular injections, or the discomfort of parenteral~     administration. Studies of vitamin A in the infant population suggest that plasma retinol~     concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have~     lower concentration and concentration < 0.35 µM/L are very dangerous. Vitamin A deficiency~     at this level may constitute a problem for preterm newborn, resulting for example, in~     histological alterations in the respiratory epithelium leading to chronic lung disease,~     retinopathy of prematurity, patency of the ductus arteriosis, and immune competence~     deficiency.~      The aim of the present study is to verify efficacy and tolerability of a new oral~     administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants < 1500g weight~     at birth, verifying the competence of the supplementation reaching ideal blood concentration~     (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in~     typical pathologies, as BPD and ROP.~   "
72933|NCT02102698|"~     Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has~     been hypothesized that abnormal interactions of dopamine with its receptors may cause the~     tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that~     selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the~     tics.~   "
72934|NCT02102685|"~     The presence of deep abscess in the neck is potentially severe, it can also lead to death in~     short term. The surgical treatment is indicated when there is commitment of the airway,~     critical condition, septicemia, complications, descendent infections, diabetes mellitus with~     no improving during the first 48 hours of parenteral antibiotic treatment and subsequent~     healing of the wounds until it heals by second intention. In this study investigators~     propose the use of vacuum Assisted Closure (VAC) that has been used satisfactorily to reduce~     edema, promote granulation, and ameliorate the tissue to afterwards reconstruct the defect,~     increase vascularity and diminish the bacterial load.~   "
72935|NCT02102672|"~     Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15~     persons per million. Although current therapy has improve disease prognosis, PAH still has a~     poor survival, with a median survival of 2.8 years after diagnosis. In the last few years~     new key elements in PAH pathogenesis have been discovered, such as the role of metabolism in~     disease onset and progression. In fact, PAH pulmonary smooth muscle cells switch into a~     glycolytic phenotype which resembles the metabolism of cancer cells. The investigators~     hypothesis is that fatty acid oxidation inhibition reverts the PAH adverse phenotype by~     restoring mitochondrial function and morphology, decreasing proliferation and restoring~     apoptosis susceptibility in pulmonary smooth muscle cells ~   "
87338|NCT01914341|"~     The purpose of this study is to determine the effects of live music on physiological~     parameters in newborn infants. The mother is asked about the effects of music on her own and~     the child's wellbeing.~   "
72936|NCT02102659|"~     1. Clinical nutritional support therapy is an important progress of modern medicine.~        2. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not~          just lack of accuracy and immediacy but also difficult to dynamically reflect the~          fluctuation trend of nutrition status.~        3. It has been reported that malnutrition affects proliferation and apoptosis of human~          cells in vivo. This preliminary study was initiated by the hypothesis that changes in~          nutritional status may be reflected rapidly in fast proliferating cells.~        4. In the previous studies the investigators already found that apoptosis rate of oral~          mucosal epithelium could reflect changes in nutritional status.There were an obvious~          decreasing in apoptosis and proliferation rate of oral mucosal epithelium in~          malnourished patients.~        5. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau~          being achieved by increase the nutrition amount continuously, Maintain this amount of~          nutrition given until the end of treatment. The investigators call this amount of~          nutrition the upper limit nutrition support therapy.~        6. The patients applying forupper limit nutrition support therapy and Formula nutrition~          support therapy separately, comparing of the two methods influences on postoperative~          wound healing, postoperative complication rate ,inflammatory response, side effects of~          chemotherapy, hospital stays and hospitalization expenses.~   "
72937|NCT02102646|"~     The purpose of this study is to investigate if androgen deprivation therapy in men with~     prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat~     distribution.~   "
72938|NCT02102633|"~     The study evaluates the effect of a single oral dose of bosutinib on the single dose~     pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.~   "
72939|NCT02102620|"~     Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI)~     of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in~     interphalangeal joints.~      Design:randomized, controlled, double-blinded study Materials and methods: sixty patients~     were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most~     symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who~     received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a~     blinded observer. The following parameters regarding the affected joint were assessed: pain~     at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure;~     swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement;~     daily requirement of paracetamol and incidence and types of local side effects after the~     procedure.~   "
72940|NCT02102607|"~     The primary aim of this study was to determine the median effective dose (ED50) for motor~     block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the~     effect of age on ED50 required for motor block.~   "
72941|NCT02102594|"~     The aim of this pilot study is to investigate the application of proteasome inhibitor~     Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with~     therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is~     that the proteasome inhibition will lead to reduced antibody titers and improved clinical~     outcome.~   "
72942|NCT02102581|"~     To study the short-term effects of tourniquet use in different ways in total knee~     arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using~     the tourniquet throughout the operation, and group B using the tourniquet starting from the~     implantation of prosthesis to the completion of the operation. Operation time, total~     measured blood loss, intraoperative transfusion volume, and complication were recorded.~     Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and~     the limb circumference, pain score, and knee joint range of motion were also recorded~     preoperatively and in postoperative 3,7 and 14 days.Investigators want to observe the~     difference between the two groups. Hypothesis was made that patients in group B may feel~     better after operation for short time use of tourniquet.~   "
72943|NCT02102568|"~     Prospective multicenter study, Out Health Products that evaluates to 2 years the impact of~     chemo-induced menopause (MCI) on the functional score of quality of life questionnaire~     QLQ-C30 in young women age childbearing and living with breast cancer.~   "
72944|NCT02102555|"~     The purpose of this study is to determine whether a single dose of IV acetaminophen can~     improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient~     satisfaction, time to readiness of discharge, and the amount of opiates post operatively~     will also be measured.~   "
72945|NCT02102542|"~     This observational study was designed to prove clinical efficacy of the well known~     glycopyrrolate which is considered an orphan drug in Thailand. Since the medication has~     never been officially used in Thai people and this particular brand Glyco-P which was made~     in India has never been officially proven of its efficacy in Thai people. The study was~     aimed to prove if this Glyco-P can modestly increase patient's heart rate, decrease~     secretion and safely used in combination with neostigmine for reversal of non-depo muscle~     relaxant drugs.~   "
72946|NCT02102529|"~     Endometriosis is one of the most frequent benign diseases that can affect women in their~     reproductive age. In severe form, the colon or rectum may be involved. It has been shown~     that the surgical treatment improve typical symptoms like pain and dyspareunia. The~     investigators evaluated the functional results and quality of life after laparoscopic~     colonic resection for endometriosis~   "
72947|NCT02102516|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative~     administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical~     procedures.~   "
72948|NCT02102503|"~     Low medication adherence in patients with coronary heart disease increases mortality.~      This study investigates if an intervention of medication review and counselling can improve~     patients' medication adherence and treatment results.~   "
72949|NCT02102490|"~     The main purpose of this study is to evaluate whether the study drug known as abemaciclib is~     effective in treating participants with breast cancer who have already tried other drug~     treatments.~   "
73028|NCT02101463|"~     This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for~     Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting~     period by a qualified vascular surgeon. In addition, it aims to examine the alternative~     sm-FBSG for patients with restricted access to centers performing clinical trials with~     commercially available devices and those patients with aortic emergencies.~   "
72950|NCT02102477|"~     This prospective, open randomized phase III surgical trial seeks to study whether radical~     prostatectomy (with or without the combination of external radiation) improves~     prostate-cancer specific survival in comparison with primary radiation treatment and~     hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer.~     Untreated or conservatively treated locally advanced prostate cancer is associated with high~     mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or~     radiation plus attempted chemotherapy if available to achieve both local control and~     elimination of potential micro metastases. Whereas there is evidence that surgery can cure~     localized prostate cancer, there are no clinical trials of multi-modal treatment of locally~     advanced prostate cancer that includes surgical removal of the prostate.~      One potential advantage of adding prostatectomy to the treatment of LAPC is that removing~     the prostate enables a full pathological assessment of the tumor characteristics and thus a~     better estimation of the risk of recurrence. Surgical treatment could thus reduce the~     numbers needed to treat with chemotherapy and radiation, and thus improve quality of life~     after treatment. In addition, evidence indicate that residual cancer in the prostate occurs~     in 25% after radiation treatment (56)and surgical removal of the prostate may improve~     survival beyond what can be achieved by radiation and ADT. On the other hand, patients~     treated with surgery, radiation and hormones will experience side effects of all three~     treatment modalities and might fare better if radiotherapy plus hormones can provide~     oncological control without prior surgery.~      A randomized clinical trial comparing two multimodal treatment regimens of which one~     includes a radical prostatectomy is therefore warranted.~   "
72951|NCT02102464|"~     The pilot study objective is to evaluate the potential benefits of LipiFlow® System~     treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye~     by assessing for improvement in meibomian gland function and reduction of dry eye symptoms~     in comparison to an untreated control.~   "
72952|NCT02102451|"~     The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis~     C (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact~     on the proportion of people with HCV within the HIV-HCV coinfected population of Australia.~      It is hypothesised that a rapid scale-up of hepatitis C treatment with interferon-free~     therapies in individuals with HIV-HCV coinfection will assist in controlling HCV infection~     in this population.~   "
72953|NCT02102438|"~     There is major concern regarding chemotherapy related toxicity in the group of women older~     than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive~     breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast~     cancer recurrence and death. Of note, older patients may experience higher risk for~     Trastuzumabe related cardiotoxicity, especially when this agent is combined with an~     anthracycline.~      Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated~     with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.~      Investigators sought to investigate safety and outcome data on a cohort of elderly patients~     treated with weekly paclitaxel combined with carboplatin and trastuzumab.~   "
72954|NCT02102425|"~     Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is~     purified by using the body's peritoneum. PD dependents on good access to peritoneum. For~     this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way~     out is called exit site and is close to the navel.~      Patients are selected at random to use bandage or not use bandage for three months, then~     cross-over. The overall objective of the research is that the patient in PD maintains a~     complete and healthy skin without signs of infection around the exit site. In the study~     effects by omission of bandage over exit site at patients in PD are examined when the~     patients are in a stable process with PD. The patient's exit site is assessed according to~     skin character and examined for infection.~      The hypothesis is that there is no greater rate of infection in patients without bandage~     than in patients with bandage over the exit site, and that patients without bandage will~     have stronger skin around exit site.~   "
72955|NCT02102412|"~     A single center study intended to evaluate the Aer-O-Scope Colonoscope System.~   "
72956|NCT02102399|"~     The purpose of this study is to verify the effects of two speech-pathology interventions:~     vocal warm-up and respiratory training in teachers who work in a public school of the city~     of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study~     and the hypothesis is that both approaches can produce positive voice changes, but the Vocal~     Warm-up will produce the most significant changes.~   "
72957|NCT02102386|"~     The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes~     in cerebral blood flow and oximetry during CEA surgery.~      Procedures include:~      Screening:~      ECG, blood draw, neurological assessment, NIHSS~      study: CerOX and TCD clock during CEA procedure, data collection from the medical~     record/monitors, neurological assessment, NIHSS~      30 day follow-up~   "
72958|NCT02102373|"~     Colonoscopy is a routinely performed procedure in children and adolescents. Proper~     visualization of the intestinal mucosa is highly dependent on the quality of the bowel~     preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the~     timing of bowel preparation is the key factor and recommends that the delay between the last~     dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation~     prior to colonoscopy has not been studied in children population, yet. The diet regimen~     before colonoscopy is likely less important than the timing of bowel preparation, however~     may influence the well-being of children.~   "
72959|NCT02102360|"~     This clinical study compared a conventional surgical technique (CST) and a minimally~     invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation~     defects.~   "
72960|NCT02102347|"~     The aim of the proposed study is to analyze the effect of the incorporation of phototherapy~     into a therapeutic exercise program on pain, functional capacity, range of motion, muscle~     strength in individuals with osteoarthritis of the knees. The participants will be allocated~     to different groups through a randomization process using opaque envelopes containing cards~     stipulating one of the three following groups: Group A (exercise protocol); Group B~     (exercise protocol + phototherapy protocol); and Group C (exercise protocol + placebo~     phototherapy protocol). Phototherapy will be performed on the knees diagnosed with~     osteoarthritis.~   "
72961|NCT02102334|"~     In total hip arthroplasty (THA), radiographic preoperative planning and postoperative~     evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD)~     require good validity, interobserver reliability and intraobserver reproducibility.~      Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by~     comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability~     and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and~     anteversion.~      90 patients with primary unilateral osteoarthritis (OA) were included in this prospective~     study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method,~     LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability~     and intraobserver reproducibility were made by three independent observers. The validity and~     degree of prediction of Sundsvall method are measured by comparing its results with the~     standard method.~   "
72962|NCT02102321|"~     Treatment of hookworm infected groups with albendazole has been shown to result in an~     increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases~     in hemoglobin levels due to treatment have been associated with significant gains in adult~     labor productivity.~      In this study, the investigators hypothesize that regular treatment of women smallholder~     farmers in a high prevalence area with the anti-hookworm drug albendazole and iron~     supplementation will improve hookworm associated anemia. Further, regular treatment of~     albendazole and iron supplementation will improve their work capacity when compared to a~     control group~   "
72963|NCT02102308|"~     A 12-week multicomponent exercise is effective in improving executive function and gait~     performance in dual-task conditions.~   "
72964|NCT02102295|"~     The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic~     acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival~     redness.~   "
72965|NCT02102282|"~     Patients are managed clinically according to ad hoc standards and scientific knowledge by a~     multidisciplinary team. Clinical decisions are made after a patient physician discussion.~     Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment,~     systemic treatment, perinatal results and follow up data are collected.~   "
72966|NCT02102269|"~     Shoulder pain is frequently reported as a complication among stroke patients. Muscular~     imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching~     the soft tissue can cause shoulder pain which impedes quality of life, length of stay and~     rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder~     orthosis is often provided to the patient. Since the use of these orthoses is not always~     considered positive by the patient nor the therapist the question rises if the investigators~     can objectify if the subacromial space is reduced when wearing a sling.~      Sonography is a valid way to asses subluxation of the shoulder joint by measuring the~     subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the~     investigators will use sonography to measure the distance between acromion and greater~     tuberosity are between acromion and the humeral head. This distance will be measured with~     and without the orthosis and also after a period of at least 4 hours of wearing the~     orthosis. This last measurement might inform us about how long the orthosis can correct the~     glenohumeral position. To validate the sonographic measurement X-rays will be taken by a~     sample of the investigators study population to compare with the ultrasound data.~      Two different orthoses will be compared. First of all the actimove sling, which is~     standardly used in the rehabilitation centre where patients will be recruited. This sling~     can be adapted by the patient itself and is very easy to wear. The disadvantage is that the~     elbow is continuously flexed, which enlarges the risk on contractures of m. biceps and m.~     brachioradialis. Also the negative influence on the interpretation of the body scheme and on~     the quantitative use of the arm can be reasons not to wear this kind of orthosis. The~     shoulderlift on the other hand is a newly developed orthosis which supports the shoulder~     joint with the arm extended. This is a more normal position during the daily living and~     stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it~     possible to position the arm flexed in order to reduce oedema of the hand if necessary. The~     control group does not wear any orthosis at all.~      Additional the investigators will evaluate passive range of motion of the shoulder,~     spasticity of the upper limb (modified ashworth scale), active motion of the upper limb~     (fugl meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and~     after a period of 6 weeks wearing the orthosis minimal 6 hours a day.~      If possible the investigators will do an evaluation of balance on a moving platform and an~     evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on~     balance and gait.~   "
72967|NCT02102256|"~     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear~     anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An~     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the~     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not~     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for~     1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility~     study to determine the safety of the ABI.~   "
72968|NCT02102243|"~     Patients with high aldosterone hormone have higher blood glucose than normal people. This~     study is being done to understand how aldosterone hormone affects the nerve activity that~     controls blood flow in the muscles and blood glucose. The information may be helpful in~     selecting blood pressure medications which can improve not only blood pressure but also~     improve blood sugar.~   "
72969|NCT02102230|"~     The purpose of this study is to investigate the efficacy of a group-based behavioral sleep~     intervention, and the incremental benefit provided by an adjunct sleep mobile app, on~     cannabis and sleep outcomes among cannabis dependent Veterans.~   "
72970|NCT02102217|"~     20% of patients who undergo major abdominal surgery will have a major complication, which~     requires invasive treatment and is associated with increased mortality, morbidity, hospital~     stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery~     (MAS) aimed at early identification of patients at risk of developing major complications~     can decrease associated morbidity and mortality. Literature studies show promising results~     for C-reactive protein as an early marker for postoperative complications, however clinical~     significance has yet to be determined. Here the investigators propose a randomized clinical~     trial in order to determine the effect of postoperative monitoring with standardized CRP~     measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L~     additional CT-scan imaging will be conducted.~   "
72971|NCT02102204|"~     This is a multicenter, single-arm, extension study to characterize the long-term safety and~     tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.~   "
72972|NCT02102191|"~     Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known~     toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco~     were found to have immediate adverse physiologic effects after short-term use that are~     similar to some of the effects seen with tobacco smoking.~      In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco~     vs a traditional cigarette.~      10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.~   "
72973|NCT02102178|"~     Pain is one of the most incapacitating symptoms because it is a complex experience that~     includes sensory and emotional perceptions, in which sensory, affective, cognitive,~     behavioral, cultural and social characteristics interact. Around 79% of advanced cancer~     cases present pain.~      There is evidence that non-pharmacological therapeutic activities are useful for controlling~     oncological pain and other symptoms resulting from such diseases.~      This study evaluated the results relating to pain modulation and improvement of emotional~     symptoms and quality of life, from an occupational therapy program applied to oncological~     patients who were receiving palliative care.~   "
72974|NCT02102165|"~     This program initially aims to recruit 1300 breast cancer patients from a large number of~     hospitals across Europe. Eligible patients are those who are 18 or older, either female or~     male, and who have not received more than 1 type of treatment from the time metastases were~     discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease~     relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be~     collected for central analyses, together with blood, serum and plasma samples. Any samples~     not analyzed immediately will be stored in an independent bio-repository to enable future~     (not yet defined) research aimed at better understanding metastatic breast cancer.~      In summary, the main objectives of AURORA are to better understand the genetic aberrations~     in metastatic breast cancer and to discover the mechanisms of response or resistance to~     therapy, in order to ultimately identify the right therapy for each individual patient. At~     the same time, patients with genetic aberrations that are being targeted by new drugs in~     development will be offered the possibility to participate in clinical trials, when approved~     and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes~     of all patients diagnosed with metastatic breast cancer.~   "
72975|NCT02102152|"~     The use of inhaled medications for the treatment of pulmonary diseases allows for the~     delivery of a high concentration of a drug at the site of disease with reduced systemic~     absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully~     used in the maintenance treatment of CF patients with chronic colonization with PA~     (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung~     functions, decrease the density of the PA in the sputum, decrease hospitalizations, and~     reduce the risk of mortality.~      Non CF Bronchiectasis share many features in common with CF, including frequent colonization~     with PA that leads to deterioration in lung function and increased morbidity. A recent~     Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics~     in the treatment of bronchiectasis, however further randomized controlled trials with~     adequate power and standardized end points are required.~      There have been reports in the literature describing the efficacy of inhaled tobramycin the~     treatment of patients with non CF bronchiectasis with eradication of PA, and significant~     improvement in respiratory symptoms. There were however patients who discontinued treatment~     due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest~     2005).~      TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and~     faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry~     powder formulation has not yet been trialed in patients with non CF bronchiectasis.~      The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in~     patients with non CF bronchiectasis, and to gather more data on the benefit of continuous~     antibiotic therapy in patients with non CF bronchectais.~   "
72976|NCT02102139|"~     Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients~     undergoing robotic thyroidectomy leads to significant haemodynamic responses such as~     increases in blood pressure and heart rate. The investigators evaluated whether a single~     preoperative dexmedetomidine injection attenuated the haemodynamic responses to~     hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil~     needed to maintain haemodynamic stability during hydrodissection.~   "
72977|NCT02102126|"~     The ENSURE study is a multi-center, prospective, single-blind, randomized, controlled study~     of the effect of renal denervation on arterial stiffness and haemodynamics in subjects with~     uncontrolled hypertension. Bilateral renal denervation will be performed using the catheter,~     delivering radiofrequency energy through the luminal surface of the renal artery.~   "
72978|NCT02102113|"~     The overall purpose of this study is to determine whether a family history of psychosis is~     associated with an altered cannabinoid system. This will be tested by studying individuals~     with and without a family history of psychosis and comparing their responses to delta~     9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that~     compared to controls with no family history of psychoses, individuals with a family history~     of psychoses will have an altered response to THC.~   "
72979|NCT02102100|"~     This study will help determine if menthol administered by inhalation via electronic~     cigarettes (e-cigarette) changes the reinforcing effects of pure nicotine administered~     intravenously in cigarette smokers who smoke mentholated or non-mentholated cigarettes.~   "
72980|NCT02102087|"~     This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD)~     in reducing the contamination rate in blood culture analysis. Blood culture data will be~     derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g.~     ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture~     may be included in this study. The ISDD will be compared to current laboratory practices for~     the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is~     defined as collection of venipuncture blood for culture without an initial diversion method~     to divert and sequester potential blood contaminants.~   "
72981|NCT02102074|"~     The investigators hypothesize that the presence of tumor cells and tumor markers in~     peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as~     early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately~     improve our understanding of tumor spread and disease recurrence.~   "
73106|NCT02100449|"~     In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction~     (HPV) results in a higher regional acceleration time (RAcT) compared to the RAcT measured in~     atelectatic consolidations.~   "
74013|NCT02088580|"~     This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep~     phase advance, and bright light therapy) on acutely depressed inpatients. The investigators~     will attempt to recruit individuals admitted to the acute inpatient unit and study the~     results of the treatment on depressive symptoms, and suicidality.~   "
72982|NCT02102061|"~     The present study aims to explore the effects of a novel multidisciplinary~     non-pharmacological intervention designed to improve health parameters and well-being in~     overweight and obese women. The proposed program is health- and quality of life-oriented,~     without a focus on weight loss, following the philosophical principles from Health at Every~     Size, and may provide an alternative mode of intervention to the traditional one, which is~     focused on the concept of weight loss at any cost. To evaluate the efficacy of the~     intervention, a mixed-method design combining both qualitative and quantitative assessments~     will be applied.~   "
72983|NCT02102048|"~     The association between HIV infection , insulin resistance and diabetes mellitus is the~     topic of many studies that have attempted to analyze the problem from different points of~     view. In fact, the risk of insulin resistance in HIV-positive patients on antiretroviral~     therapy seems to depend not only on the same factors that determine its incidence in the~     general population , but also on the effects of antiretroviral therapy on glucose~     metabolism. To confirm this observation, studies that have evaluated the incidence of~     diabetes in patients with HIV infection on antiretroviral therapy have shown that the~     incidence of diabetes in infected individuals is significantly higher than that observed in~     the uninfected population. Moreover others preliminar stadies observed that protease~     inhibitors may induce hyperglycemia and diabetes mellitus. Anyway at this moment no large~     data are available that indicate the utility to modify the antiretroviral therapy in HIV~     positive patients with a damage of glucose metabolism.~      ATAGLU is a cohort composed by HIV positive patients in effective and stable combined~     antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried~     out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in~     part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part~     continue with LPV/r + OBT .~      The objective was to characterize the changes of carbohydrate profile of a cohort of~     patients who made a switch from a regimen with LPV/r to boosted or unboosted ATV.~   "
72984|NCT02102035|"~     Reconstruction of soft tissue defects in the fingers continues to be a challenge problem.~     The study reports reconstruction of small to moderate defects of the fingers with the direct~     and reversed dorsal digital island flaps and evaluates the results of the use of the~     flaps.The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament~     scores of the flap and joint motion.~   "
72985|NCT02102022|"~     Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid~     (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.~   "
72986|NCT02102009|"~     The purpose of this study is to determine whether nutritional support with a complete~     formula is effective to improve malnutrition and respiratory function in patients with~     chronic pulmonary disease compared to the standard hospital dietary advise.~   "
72987|NCT02101996|"~     The average American diet consumed by a significant proportion of the adult population,~     supplies excessive calories and large amounts of saturated fat. Saturated fats can be~     cleared and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat~     are found in the blood, along with markers of poor muscle metabolism.~      Both fats and amino acids are processed by the same metabolic pathways in muscle, and the~     investigators hypothesize that meals with greater amounts of saturated fat slow muscle~     metabolism. A better understanding of the interaction of these to metabolites will allow for~     the development of future medications to treat muscle loss in sick individuals and the~     elderly.~   "
72988|NCT02101983|"~     High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients~     with acute myeloid leukemia. However, most patients receiving this therapy are required to~     be admitted to the hospital during their treatment course.~      The purpose of this study is to compare the safety and cost of high-dose cytarabine~     treatment given in an in-patient setting versus an out-patient setting.~   "
72989|NCT02101970|"~     The purpose of this study is to determine if high dose supplementation with the omega-3~     fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study~     population and if there is an increase in the favorable change in blood and tissue breast~     cancer risk factors when compared to weight loss alone.~   "
72990|NCT02101957|"~     The purpose of this study is to evaluate the effect of cysteamine in patients with~     symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo)~     on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study~     group 1996).~   "
72991|NCT02101944|"~     This pilot phase I clinical trial studies the side effects and best dose of wild-type~     reovirus when combined with carfilzomib and dexamethasone in treating patients with multiple~     myeloma that has come back following treatment or does not respond to treatment. Drugs used~     in chemotherapy, such as dexamethasone and carfilzomib, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. A virus called wild-type reovirus may be able to kill cancer~     cells without damaging normal cells and seems to work best when given with chemotherapy.~     Giving wild-type reovirus with chemotherapy may be a more effective treatment than~     chemotherapy alone.~   "
73011|NCT02101684|"~     Granulosa Cell ovarian carcinoma is an infrequent subtype of neoplasia well differentiated~     from epithelial tumors. They account for 5% of all ovarian malignancies and, with an~     incidence of 0.4-1.2 cases per 100000 habitants, is considered as a rare disease.~      Though most cases are identified at initial stages and can be cured through surgical~     resection, distant recurrences have been documented even 10 years after resecting the~     primary tumor. At advanced stage it is a lethal disease.~      Unfortunately because of the low incidence of this disease randomized clinical trials are~     lacking. In fact current evidence for treatment is provided by case reports, retrospective~     studies and phase II clinical trials performed one decade ago.~      Orteronel, a novel, orally active, selective inhibitor of 17,20-lyase, is being developed as~     an endocrine therapy for relevant hormone-sensitive cancers such as prostate cancer and~     breast cancer. Orteronel is expected to suppress sex hormone levels in both circulation and~     relevant hormone-dependent malignant tissue. Since sex hormone overproduction has been~     demonstrated in granulosa cell ovarian tumors and seems to play a major role in this~     disease, this study will assess the efficacy or orteronel treating such tumors.~   "
73012|NCT02101671|"~     The purpose of this study is to determinate if the patients submitted to laparoscopic~     surgery in trendelemburg position develope more inadequate anaesthesic emergence than~     patients submitted to laparoscopic surgery in other positions.~   "
72992|NCT02101931|"~     Research Problem:~      Bladder cancer is one of the major health concerns of the world. The present methods of~     diagnosis are: Ultra sound, Cystoscopy, CT scan and urine cytology. All these are stressful~     to the patients, particularly Cystoscopy which is commonly employed for the follow up of~     Bladder cancer patients.~      Research Significance:~      The present study will employ a new photodynamic diagnostic procedure to quantify a certain~     cancer specific biomarker called Porphyrin, which selectively binds on to the bladder cancer~     tissues. In this context the present technique offer viable, very easy and reliable table~     top instrumentation for diagnosis and continual monitoring of disease regression through~     urine.~      Research Objectives:~        -  To quantify bladder cancer specific biomarkers such as Porphyrin using photodynamic~          diagnostic procedure~        -  To find out whether this technique might be a new and easy tool for bladder cancer~          diagnosis only by urine.~      Research Methodology:~      The bladder cancer patients is required to swallow a chemical called ALA (5 Amino levulinic~     Acid hydrochloride), about 10mg/kg body weight which will play a role of biological~     indicator. ALA gets metabolized into certain types of porphyrins which selectively bind on~     to the tumor tissues (for a longer time than the normal tissues). 5ml of blood and one urine~     samples will be taken before using ALA. The patient must drink water then the urine will be~     collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by~     photodynamic diagnostic procedure.~   "
72993|NCT02101918|"~     This phase II trial studies ziv-aflibercept in treating and perfusion computed tomography~     perfusion imaging in predicting response in patients with pancreatic neuroendocrine tumors~     that have spread to other parts of the body or cannot be removed by surgery. Ziv-aflibercept~     may stop the growth of tumor cells by blocking blood flow to the tumor. Diagnostic~     procedures, such as computed tomography perfusion, imaging may help measure a patient's~     response to ziv-aflibercept treatment.~   "
72994|NCT02101905|"~     This pilot clinical trial studies how well lapatinib ditosylate before surgery works in~     treating patients with high-grade glioma that has come back after a period of time during~     which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
72995|NCT02101892|"~     A major reason for the substantial underuse of pharmacological prevention of migraine is its~     inadequate efficacy, since only ~50% of patients respond to a specific agent. There is~     currently no evidence-based way to identify the patients that will respond to a specific~     preventive treatment. Amitriptyline is one of the commonest agents used for migraine~     prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of~     analgesics according to pain inhibitory capacity has been shown effective by our group for~     painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition~     capacity gained more from a drug that augment pain inhibition as compared to those with~     efficient inhibitory capacity. The investigators now propose to assess migraineurs for their~     pain inhibition capacity, and examine whether, along similar reasoning, those with reduced~     inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and~     neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs,~     who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized~     two arms parallel double blind design, and followed up for attacks reduction. The~     investigators expect to identify the best predictors for efficacy of migraine prevention by~     the study drug. This approach will promote individualization of migraine therapy.~   "
72996|NCT02101879|"~     Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2~     (HER2) positive and it has been well known that HER2 overexpression is associated with more~     aggressive phenotype and poor prognosis with resistance to certain chemotherapeutic agents.~      Trastuzumab administration as an adjuvant and in metastatic HER2 positive breast cancer is~     associated with both symptomatic and asymptomatic cardiotoxicity. The incidence of~     trastuzumab-mediated cardiotoxicity were 27% with antracycline combination and 13% when it~     was administered with paclitaxel .~      Pertuzumab, a recombinant humanized monoclonal antibody binding to the HER2 dimerization~     domain, prevents dimerization of HER2 with other HER receptors (HER3,HER1, and HER4)~     especially with HER3. Blocking HER2-HER3 dimerization is postulated to be the most~     clinically relevant action of pertuzumab and this can effectively block her2-mediated cell~     signaling.~      Pertuzumab is indicated in combination with trastuzumab and docetaxel for the treatment of~     patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2~     therapy or chemotherapy for metastatic disease.~      Treatment of breast cancer with pertuzumab plus trastuzumab plus docetaxel as first line~     treatment until disease progression might be complicated by cardiotoxicity in up to 14.5% of~     the Patients.~      Cardinale et al showed that troponin I (TNI) positive identifies trastuzumab-treated~     patients who are at risk for cardiotoxicity and are unlikely to recover from cardiac~     dysfunction despite HF therapy.~      There is very little data about the reversibility and identification of patients at risk for~     cardiotoxicity of the pertuzumab plus trastuzumab plus docetaxel regimen and of those who~     will not recover from cardiac dysfunction,this information is crucial. The usefulness of~     troponin I (TNI) and Brain natriuretic peptide (BNP) in the identification of patients at~     risk for PT cardiotoxicity and in the prediction of LVEF recovery has never been~     investigated.~      based on this background , this study aim is to evaluate the cardiotoxicity of pertuzumab~     plus trastuzumab plus docetaxel regimen and the application of troponin I (TNI) and Brain~     natriuretic peptide (BNP) in this setting.~   "
72997|NCT02101866|"~     This Phase 1 study aims to determine the oral bioavailability of a single dose of a new~     vapendavir tablet formulation and compare it to that of the previous vapendavir capsule~     formulation. The safety of both drug products will also be assessed.~   "
72998|NCT02101853|"~     This randomized phase III trial studies how well blinatumomab works compared with standard~     combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that~     has returned after a period of improvement (relapsed). Monoclonal antibodies, such as~     blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not~     yet known whether standard combination chemotherapy is more effective than blinatumomab in~     treating relapsed B-cell acute lymphoblastic leukemia.~   "
72999|NCT02101840|"~     The objective of this study is to examine the abuse liability of a single 40mg dose of 2~     controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent~     recreational opioid users by assessing the self-reported acute effects of the drugs and~     taking blood samples to measure drug concentrations. The investigators think there may be~     differences in how well these drugs are liked when swallowed whole due to differences in how~     the products are formulated.~   "
73000|NCT02101827|"~     To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic~     procedures.~   "
73013|NCT02101658|"~     The purpose of this project is to examine potential bias or expectancies in individuals'~     measurement and recording of weight in a clinical-research setting.~   "
73165|NCT02099682|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of lansoprazole (Takepron) for up to 12 months in the routine clinical~     setting in patients receiving low-dose aspirin~   "
73001|NCT02101814|"~     The prevalence of obesity is steadily growing in many parts of the world in order to reach~     epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute~     to the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also~     is considered a secretory tissue by producing numerous adipokines involved in a chronic~     state of inflammation, which may interfere with the neuroendocrine regulation of energy~     balance that affect the weight loss process. The bariatric surgery is recommended as the~     most effective tool in the treatment and control of morbid obesity. The study population~     will consist of patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The~     study was performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is~     a prospective cohort study with follow up of 6 and 24 months. The aim of this study is to~     assess the effects of weight loss after bariatric surgery associated anthropometric~     characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast~     growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory~     (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP),~     plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α),~     intercellular adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and~     neuroendocrine regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte~     stimulating hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide~     (AgRP), as well as the quality of life in obese adults.~   "
73002|NCT02101801|"~     Over 60% of crops in Israel are grown in recycled treated waste water. This study aims to~     determine whether minute quantities of drugs such as Carbamazepine can be found in~     individuals who ingest vegetables grown in waste water.~   "
73003|NCT02101788|"~     This randomized phase II/III trial studies how well trametinib works and compares it to~     standard treatment with either letrozole, tamoxifen citrate, paclitaxel, pegylated liposomal~     doxorubicin hydrochloride, or topotecan hydrochloride in treating patients with low-grade~     ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to~     other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether trametinib is more effective~     than standard therapy in treating patients with ovarian or peritoneal cavity cancer.~   "
73004|NCT02101775|"~     This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1~     inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with~     ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of~     time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their~     deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development~     and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may~     help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor~     MK-1775 may block the WEE1 protein activity and may increase the effectiveness of~     gemcitabine hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells~     without causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride~     with or without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian,~     primary peritoneal, or fallopian tube cancer.~   "
73005|NCT02101762|"~     The Foley catheter is one component in a catheter insertion procedure that could contribute~     to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter~     insertion procedures using the ERASE CAUTI Tray system may help to lower these infection~     rates.~   "
73006|NCT02101749|"~     This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years~     will be enrolled and randomized to one of 2 study arms:~        1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per~          strain/ 0.1 ml dose) (group A - 110 participants)~        2. Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose)~          (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total~          follow up period is 60 days.~   "
73007|NCT02101736|"~     This study, A Phase II Study of Cabozantinib (XL l84) for Plexiform Neurofibromas in~     Subjects with Neurofibromatosis Type I Age 16 years or greater is for participants that~     have been diagnosed with Neurofibromatosis Type 1 (NF1) and have a type of tumor called a~     plexiform neurofibroma. Neurofibromas are tumors that develop from the cells and tissues~     that cover the nerves. Plexiform neurofibromas can be disfiguring, painful, and~     life-threatening. These types of tumors typically do not respond well to most treatment~     approaches such as chemotherapy, radiation, and surgery because of their slow growth and~     location near vital structures of the body such as nerves, blood vessels, and the airway.~      The purpose of this Phase II Study is to determine the response rate of NFI patients with~     plexiform neurofibromas treated with Cabozantinib therapy using MRI scans. Cabozantinib is~     thought to work on tumors by blocking pathways that are involved in the growth of tumors and~     blood vessels that supply tumors. Cabozantinib is considered experimental because it has not~     been approved by the Food and Drug Administration (FDA).~   "
73008|NCT02101723|"~     The investigators propose to study the effects of increased iron intake by home~     fortification of complementary foods on the gastrointestinal microbial development,~     inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds~     living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one~     of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients,~     including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d~     Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize~     that the microbiome will be significantly different in the three groups and that Zn~     absorption and status, in addition to immune and oxidant status will be improved in the~     non-Fe fortified groups when compared to the Fe-fortified group.~   "
73009|NCT02101710|"~     This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg~     in sixty healthy Korean male subjects.~   "
73010|NCT02101697|"~     This Randomized Controlled Trial has been designed to test the efficacy of a behavioral~     intervention to reduce HIV-related stigma among nursing students and ward attendants in 16~     sites in South India and 8 sites in North India.~   "
73025|NCT02101502|"~     This work aimed to prepare the obstetrics and gynecology department for high education and~     health care accreditation.~   "
74014|NCT02088567|"~     The overall objective of this study is to evaluate the effectiveness of dHACM in reducing~     scar tissue formation in total knee replacement patients.~   "
73014|NCT02101645|"~     The research group will choose no more than 10 patients having a lower extremity venous~     ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization.~     In this study the investigators will follow and monitor the healing of the wound and~     effectiveness of compression therapy using bioimpedance measurement based method. The~     investigators will also treat the wounds using periodical low intensity direct current~     (LIDC) stimulation therapy.~      Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose~     built wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement~     electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter~     and impedance reference electrodes (in contact with the intact skin surrounding the wound~     area).~   "
73015|NCT02101632|"~     Topical application of BV ointment in patients with Research Diagnostic~     Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to~     placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days.~     Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary~     contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was~     compared with placebo in masseter myofascial pain in patients with TMD~   "
73016|NCT02101619|"~     Aortic stenosis (AS) is the most common valve disease in the United States and most common~     indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is~     insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal~     timing of surgical intervention remains critical. However, the changes in structure and~     electrical activity of the cardiac muscle can be assessed by noninvasive imaging and~     electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or~     collagen deposits are frequently observed in AS patients and have a negative impact on~     patient outcomes. In this project, our objective is to determine whether echocardiographic~     image analysis of integrated backscatter (IB), which can express changes in myocardial~     tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left~     ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS~     interval have a role in risk stratification for AS patients and to apply those methods to~     identify which patients would benefit from surgical intervention.~      The investigators hypothesize that 1) the severity of myocardial damage can discriminate the~     prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures~     of the severity of myocardial damage. The investigators will measure the severity of~     myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic~     significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic~     measures will also be tested for diagnosing severity of myocardial fibrosis.~   "
73017|NCT02101606|"~     Rationale The only proven therapy for acute stroke is tPA within 4.5 hours of symptom onset.~     This is the standard of care for patients presenting to our hospital within that time frame.~     Thrombolysis outside the 4.5 hour window is considered only on experimental or compassionate~     grounds. Tenecteplase (TNK) is a genetically modified variant of tPA that has many~     theoretical advantages in acute stroke. Studies show that systemic plasminogen activation is~     higher after tPA administration, relative to TNK and this is associated with an increased~     risk of bleeding events. Imaging cerebral blood flow (CBF) with MRI (perfusion weighted~     imaging-PWI) and CT perfusion (CTP) can be performed routinely with standard clinical~     scanners. Patients with evidence of large volumes of tissue with low CBF, that is also~     structurally intact, as demonstrated by either normal signal on Diffusion weighted imaging~     (DWI) or normal cerebral blood volume (CBV) are considered to have penumbral patterns.~     Patients with penumbral patterns appear to be the ideal candidates for thrombolytic therapy,~     regardless of time from onset.~      Study Hypotheses~        1. The primary aim of this study is to demonstrate the feasibility and safety of TNK based~          thrombolysis in ischemic stroke patients presenting 4.5-24 hours after symptom onset.~        2. It is hypothesized that treatment with TNK in patients with penumbral patterns will be~          associated with reperfusion, early neurological improvement and penumbral tissue~          salvage.~      Study Design The study is planned as an open label feasibility and safety study of acute~     treatment with TNK in ischemic stroke patients with penumbral patterns evident on advanced~     MRI or CT perfusion sequences.~      Study Outcomes The primary outcome of this study is a safety endpoint, specifically the~     frequency of symptomatic hemorrhagic transformation evident on MRI or CT images on 24 h or~     day 5 scans. The ECASS II system for rating hemorrhagic transformation will be applied to~     all GRE/SWI images~      Significance Current treatment paradigms have not permitted success of tPA to be extended~     beyond narrow and limiting therapeutic window of 4.5 hours. Clearly, more effective patient~     selection criteria are required. Penumbral imaging is biologically plausible, practical and~     has been shown to be predictive of outcome. Application of these imaging techniques to the~     acute stroke population is the most promising strategy for extending the therapeutic window~     and for introducing superior thrombolytic agents.~   "
73018|NCT02101593|"~     Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in~     advanced Hepatocellular Carcinoma (HCC).~   "
73019|NCT02101580|"~     Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in~     subjects with Advanced Pancreatic Carcinoma.~   "
73020|NCT02101567|"~     The investigators compare the effectiveness and adverse effects of I.V carbetocin versus~     oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean~     section.~   "
73021|NCT02101554|"~     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine~     sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.~   "
73022|NCT02101541|"~     The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of~     focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of~     paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and~     post-procedural heart rhythm monitoring.~   "
73023|NCT02101528|"~     Decreased muscle strength has been reported to be a factor contributing to increased~     incidences of falling in the elderly patients causing fractures, joint dislocations, severe~     soft tissue lesions and head trauma. Parkinson's Disease (PD) patients often complain of~     weakness and it has been reported that they have reduced muscle strength, decreased rate of~     force development, impaired ability to maintain constant force, and increased muscle~     coactivation during balance perturbation tasks. The specific cause of this weakness is not~     known, and in this study the investigators have analyzed and measured isokinetic muscle~     strength in PD patients to clarify this issue. The investigators have compared the data~     obtained with those of age-matched controls.~   "
73024|NCT02101515|"~     The hypothesis of this study is that extending the second stage of labor beyond current ACOG~     suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United~     States is around 30 percent. This is a number that continues to be increasing over the last~     few decades and will continue to climb. Each subsequent cesarean section puts the mother and~     baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal~     placentation, febrile morbidity and death. The most common reason for a cesarean delivery is~     a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean~     delivery. The aim of this study is evaluate if extending the second stage of labor affects~     the cesarean delivery rate and subsequent perinatal morbidity.~   "
73029|NCT02101450|"~     During cesarean section, it is important to provide hemostasis as well as to decrease the~     amount of hemorrhagic fluid and fibrin in the abdominal cavity. Hemorrhagic fluid and fibrin~     together may cause adhesion formation and therefore postoperative ileus, retardation in~     regaining the gastrointestinal functions as well as prolongation of the operation itself.~     Dragging the uterus out of the abdominal cavity during cesarean section before removing the~     placenta (extra-abdominal removal of the placenta) may decrease the amount of blood flowing~     into the abdominal cavity during removal of placenta. In this study the investigators aimed~     to evaluate the influence of intra abdominal vs extra abdominal removal of placenta on~     duration of operation, the amount of aspirated fluid during the operation, difference~     between postoperative hemoglobin and hematocrit levels, postoperative pain score, additional~     need of analgesia, postoperative bowel movements, postoperative endometritis and wound~     infection.~   "
73030|NCT02101437|"~     For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we~     will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the~     basis of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin~     + ticagrelor, according to medical guidelines currently no other disposal alternative~     proposal (unless adverse drug tolerance or bleeding can not be administered); idea of this~     experiment for acute coronary syndrome or conventional cardiac catheterization after~     stenting, platelet miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac~     catheterization and interventional treatment of clopidogrel or ticagrelor acceptance of~     platelet reactivity (PRU) correlation values (given clopidogrel or ticagrelor determined by~     the clinician, the patient follow-up experiment to track only and observation), aims to~     explore under different platelet reactivity (hyper-reactive or hypo-reactive), their~     differences in miRNA performance.~   "
73031|NCT02101424|"~     This study will compare the data from pulse oximeters to capnographers as they are used to~     monitor patients who are being observed in the Emergency Department for a suspected overdose~     of alcohol or other drugs. The investigators will compare monitor data from patients who are~     and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of~     airway interventions, and to detect ventilator changes noted on the opposing monitor. There~     will not be any interventions during this study other than the collection of data from the~     monitors and observation of the care of patients.~   "
73032|NCT02101411|"~     Since thrombus formation is a very complex procedure in vivo, platelet function testing~     methods in vitro might only reflect the degree of inhibition of platelet from a certain~     level, which do't reflect the functional status of platelets in vivo adequately. There are a~     variety of signal transduction pathways involved in the formation of platelet activation and~     thrombosis. Gurbel et al. first reported individuals with variability on clopidogrel~     treatment response in 2003, and proposed the concept of clopidogrel resistance. Different~     patients received the same dose of aspirin or other anti -platelet drug such as clopidogrel~     , due to various reasons bound to lack some patients antithrombotic efforts to increase the~     incidence of thrombotic events , while another part of the patient easily understood~     antithrombotic excessive bleeding events,  antithrombotic individualized treatment , ~     according to differences in patient against platelet drugs or anticoagulant drug reactions~     and adjust the treatment plan , is the direction of antithrombotic therapy in the future.~      There are a number of studies have shown that patients with no response Clopidogrel ,~     measuring the relationship between high platelet reactivity and clinical adverse ischemic~     events displayed between platelet activity . However, there is still lack of quantitative~     threshold high platelet reactivity and the risks associated with the clinical consensus . In~     addition, there are only limited data support, to measure platelet function -based therapy~     to improve the clinical efficacy of the concept . Over the years, more than 20,000 cases~     reported in patients with numerous studies confirm that high platelet reactivity after PCI~     with stent thrombosis , including cardiovascular events , including an increased risk of~     significant correlation . Pharmacodynamic analysis GRVITAS trial showed significantly lower~     platelet reactivity associated with a lower risk of adverse cardiovascular events . Brar in~     more than 3000 cases of patients published in JACC Meta-analysis showed that high platelet~     reactivity  of patients whose cardiovascular death, heart attack and stent thrombosis~     occurred more than twice the rate of  non-high platelet reactivity  patients .~      Two new anti-platelet drugs (Prasugrel and Ticagrelor) in several recent randomized trials~     have considerable persuasive , and has included some guidance in the current guidelines.~     Ticagrelor even more than Prasugrel in pharmacodynamic studies more effectively inhibit~     platelet , and has a lower risk of bleeding. Cilostazol is an old drug , mostly for the~     treatment of intermittent claudication , in recent years there are also some testing and~     coronary stents prevent restenosis after angioplasty , however, so far , there is little~     direct comparison Cilostazol and Ticagrelor related articles .~      We designed this test , in addition to testing for high yellow people treat DAPT (dual~     anti-platelet therapy) under the platelet reactivity (high on-treatment platelet reactivity)~     ratio , this population of patients with ticagrelor instead for a month or cilostazol~     treatment after its platelet reactivity changes and compare between the two groups , and~     even track six months after the bleeding and adverse cardiovascular events rate? Through~     this test we can compare the treatment for patients with high platelet reactivity of what~     strategies more appropriate.~   "
73033|NCT02101398|"~     The aim of this work is to study the effect of transcranial direct current stimulation~     combined with naming therapy in acute and post-acute stroke comparing four bihemispheric~     positioning electrodes to a sham condition.~   "
73034|NCT02101385|"~     This study will test the theory that therapy designed for each individual's tumor will~     improve outcomes over standard of care in a population that needs a better standard.~   "
73035|NCT02101372|"~     The AGES-CM consortium aims to study the interaction between the polymorphisms of the~     candidate genes related with neurodevelopment, neurotransmission, brain progressive changes,~     cognitive functioning and stressful life events (prospective- and retrospectively assessed)~     and the association of the interactions with structural and functional brain measures,~     neuropsychological performance, biochemical and oxidative status in both in patients and~     controls. The investigators study aimed to examine the effectiveness of a parallel,~     structured, and specific psychoeducational group intervention (PE) for adolescent patients~     and their families by comparing it with treatment as usual).~   "
73036|NCT02101359|"~     The purpose of this study is to determine the efficacy and safety assessment of T2380 for~     mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group~     (topical mydriatics and anaesthetic) 2X246 patients.~   "
73037|NCT02101346|"~     The aim of the present study is to identify the effects of different dietary fats on the~     body's immune system and how different types of cells respond. There will be two rounds of~     recruitment in order to satisfy different aims of the study. In the first round, volunteers~     will be asked to undergo five separate 1-day assessments where you will be given diets in~     the form of milkshakes differing in amounts of fats. Volunteers recruited for this round~     will also be given the opportunity to participate in the second round of recruitment and~     feeding. A second round of recruitment will then take place to complete recruitment, if~     required. In the second round, volunteers will be asked to undergo two separate 1-day~     assessments in the form of milkshakes with differing fats, one of which will contain a~     tracking label added to the food during preparation. This label is in the form of is a~     'stable isotope' and safe to consume (used commonly in some medical tests - see below for~     further information) and will allow the researchers to later find the food particles within~     blood cells. During these 1-day assessments blood samples will be collected to identify the~     impact different diets have on the immune system, specifically monocyte cells thought to~     play an important role in the development of atherosclerosis, a primary cause of~     cardiovascular disease.~   "
73038|NCT02101333|"~     First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and~     induction of remission in Takayasu arteritis (TA).~   "
73039|NCT02101320|"~     In France, breast cancer affects approximately 53,000 new cases per year. The investigators~     have to take care more and more women with subclinical lesions (nonpalpable), and it~     represents around 25% to 35% of the diagnosed breast cancers. The main problem of the~     surgical management of these lesions is the quality of preoperative identification which~     determines the quality of surgery and oncological and cosmetic outcomes. For this type of~     lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed.~     This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The~     investigators want to evaluate the potential benefits of using a hand held camera called~     TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside~     and in the operating theater.~   "
73040|NCT02101307|"~     This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in~     patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment~     regimen will be directed by the treating physician according to clinical practice. Patients~     are expected to be observed for approximately 6 months after beginning treatment.~   "
73176|NCT02099539|"~     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in patients with relapsed or refractory multiple myeloma.~   "
73041|NCT02101294|"~     The study hypothesis is that there is a relationship between the keyboard layout and carpal~     tunnel syndrome (CTS). Specifically, use of the standard QWERTY keyboard increases the risk~     of symptoms of carpal tunnel syndrome. The QWERTY keyboard requires more effort by the~     fingers than necessary to perform the required work, i.e. data or word entry; up to 200~     percent more flexion and extension and 100 percent more distance traveled.~      The purpose of the protocol is to evaluate two keyboard layouts for carpal tunnel syndrome~     therapy, and to see if the efficient keyboard, Finger Relief, can be used as an adjunctive~     tool to other treatments or therapy for CTS for typists. Subjects who had received a~     diagnosis of carpal tunnel syndrome from their medical doctor and, where not~     contraindicated, had received confirmation of the diagnosis of carpal tunnel syndrome with a~     nerve conduction velocity (NCV) study participated in four typing sessions to compare onset~     and severity of carpal tunnel symptoms. Testing sessions alternated between keyboards. The~     keyboard selected for the first typing session was determined by random assignment. Twenty~     subjects completed all four typing sessions. The test protocol consisted of a medical~     history, 3 tests of the subjective pain experience of the subject (visual analogue scale /~     verbal rating scale, and hand diagram), 2 clinical measures of physical manifestations of~     swelling associated with carpal tunnel syndrome (water volume/tape measure), and a measure~     of the length of time spent typing on each keyboard layout - QWERTY and TheOrdinals (the~     Finger Relief keyboard).~   "
73042|NCT02101281|"~     The purpose of the study is to assess the efficacy and safety of different doses of rhNGF~     when administered as eye drops to patients with Dry Eye.~   "
73043|NCT02101268|"~     This study is to determine the efficacy of momelotinib (MMB) versus best available therapy~     (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or~     post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who~     were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).~      Participants will be randomized to receive either MMB or BAT for 24 weeks during the~     randomized treatment phase, after which they will be eligible to receive MMB in an extended~     treatment phase for up to an additional 168 weeks. After discontinuation of study~     medication, assessments will continue for 12 additional weeks, after which participants will~     be contacted for survival follow-up approximately every 6 months for up to 5 years from the~     date of enrollment.~   "
73044|NCT02101255|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early approximal carious lesions compared to fluoride.~   "
73045|NCT02101242|"~     A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach~     chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery.~     Regional cerebral oxygen saturation will be measured continuously during surgery. Duration~     and extent of deviations from individual baseline values will be recorded and detected~     deviations treated according to their clinically apparent cause (e.g.~     hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard~     operating procedures (SOPs).~      Patients are then followed up until the end of hospital stay or for a maximum of 10 days~     after surgery. Their level of cognitive function will be tested and compared to the data~     acquired before surgery to detect impairment, delirium or postoperative cognitive deficit~     (POCD).~      The purpose of this pilot study is to evaluate the design and conduct of a projected full~     scale observational clinical study.~   "
73046|NCT02101229|"~     To assess whether the DIABELOOP algorithm provides better glycemic control than the usual~     algorithm of T1D patients on pump therapy:~        -  at meals, with CHO roughly assessed by the patient.~        -  during and after physical activity sessions qualified as moderate by the patient.~      Primary endpoint : time within the glycemic reference range. The study will be conduct with~     15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and~     CHU of Montpellier.~   "
73047|NCT02101216|"~     Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis,~     termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol~     (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance~     of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence~     to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in~     patients with moderate to severe plaque psoriasis.~   "
73048|NCT02101203|"~     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety~     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive~     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.~      This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to~     study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).~      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in~     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory~     mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured~     within 24 hours after each sexual activity. The following hypotheses will be tested:~      Lybridos, as compared to placebo, will significantly increase the number of satisfying~     sexual events.~      Objectives:~      To investigate the efficacy of Lybridos as compared to placebo in increasing the number of~     satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire~     disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms~        -  To identify the optimal dose of Lybridos to take into phase 3 clinical development~        -  To confirm that Lybridos has superior efficacy as compared to testosterone alone and to~          buspirone alone~        -  To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or~          sexual desire/arousal~        -  To evaluate the safety profile of Lybridos~   "
73049|NCT02101190|"~     The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients~     with moderate chronic hepatic impairment and in matched healthy subjects.~   "
73050|NCT02101177|"~     The aim of the study is to analyse data coming from two treatment centres of the National~     Treatment Program Centres of hepatitis C in Egypt~   "
73051|NCT02101164|"~     This study will estimate the total time for the preparation and administration of denosumab~     and the total time for the preparation and administration of pamidronate.~   "
73223|NCT02098928|"~     Main objective: to compare the effects of hand-acupuncture and electro-acupuncture~     stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the~     safety and acceptability of hand acupuncture and electroacupuncture stimulation~   "
73052|NCT02101151|"~     The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both~     nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels~     may be inversely related to the prevalence of diabetes, insulin resistance and metabolic~     syndrome. However, to demonstrate a causal relation between vitamin D and glucose~     metabolism, evidence from randomized and adequately powered placebo-controlled intervention~     trials is needed.The trials available on the effect of Vitamin D supplementation are not~     conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial~     in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of~     vitamin D supplementation on glycemic control and obesity parameters.~   "
73053|NCT02101138|"~     Background:~      - Eosinophils are white blood cells that fight infections. In people with hypereosinophilic~     syndrome (HES), eosinophil levels are too high and can damage their organs. HES is usually~     treated with steroids, but steroids can cause side effects and stop working over time.~     Researchers want to see if a drug called dexpramipexole, being developed by Knopp~     Pharmaceuticals, can help people with HES to reduce their steroid dose.~      Objective:~      - To test whether dexpramipexole can reduce the steroid dose needed to control eosinophilia~     and HES symptoms.~      Eligibility:~      - Adults 18 and older with HES who respond to steroids, but need more than 10 mg daily to~     control eosinophilia and symptoms.~      Design:~        -  The study will last 9 months with 6 visits to NIH.~        -  Participants will be screened with medical history, physical exam, and urine and blood~          samples.~        -  Participants steroids will be tapered to the lowest effective dose. During this time,~          blood will be drawn weekly. Participants will take this dose for 2 weeks before~          starting the study drug.~        -  Participants will take the study drug twice daily by mouth for 12 weeks along with~          steroids. The steroid dose will not be decreased during this time and participants will~          be seen monthly for a medical history, physical examination and blood work.~        -  Just before and 12 weeks after starting the study drug, the following tests will be~          performed:~        -  medical history and physical exam~        -  blood and urine tests~        -  lung function tests~        -  electrocardiogram (measures heart electrical activity)~        -  echocardiogram (takes pictures of the heart using sound waves)~        -  bone marrow biopsy (a needle inserted into the hip bone that removes bone marrow cells~          for study)~        -  After 12 weeks, the participants steroid dose will be tapered again to the lowest~          effective dose while on study drug.~        -  Two weeks after the lowest effective dose is reached, participants will return for a~          medical history, physical examination, blood work, lung and heart tests.~        -  Participants who respond to the study drug may be able to continue to receive the drug~          on a planned separate study.~        -  Four weeks after stopping the study drug, participants will have medical history,~          physical exam, and blood tests.~   "
73054|NCT02101125|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.~   "
73055|NCT02101112|"~     The purpose of this study is to determine whether the bioavailability of apixaban crushed~     tablets suspended in water or mixed with applesauce is similar to the bioavailability of~     apixaban whole tablets administered orally.~   "
73056|NCT02101099|"~     The aim of the study is to determine if more force is used during colonoscopy when patients~     receive monitored anesthesia with propofol versus conscious sedation. Force measurements~     will be performed using the colonoscopy force monitor (CFM). This device measures the~     magnitude and direction of force applied to the insertion tube of a standard colonoscope~     during colonoscopy.~   "
73057|NCT02101086|"~     The purpose of this study is to investigate the efficacy and safety of autologous cord blood~     transfusions in very-low-birth-weight premature infants, and to evaluate the developmental~     outcomes of the infants who received autologous transfusions.~   "
73058|NCT02101073|"~     The overall aims of the study are:~        -  To assess the bioavailability of single doses of ALX-0061, administered s.c. at three~          dose levels, using 2 corresponding single i.v. dose levels as reference.~        -  To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.~        -  To further determine the safety and tolerability of ALX-0061.~        -  To further evaluate the systemic (serum) immunogenicity of ALX-0061.~   "
73059|NCT02101060|"~     Research is needed to determine safe and effective exercise rehabilitation programs to~     prevent and improve physical disability in older adults living with HIV. This problem is of~     great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over~     50 years of age (64%). The combined effect of aging and inflammation increase the risk for~     physical disability in older HIV-infected veterans. This translational exercise training~     trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and~     resistance training to attenuate the functional declines of aging with HIV by reducing the~     deleterious consequences of chronic inflammation. Findings will guide future rehabilitation~     research on cardiac remodeling and inflammation of skeletal muscle. The proposed research~     will advance the goal to develop effective rehabilitation strategies that improve the health~     of older HIV-infected veterans.~   "
73060|NCT02101047|"~     Three different regimens of phenylephrine are being evaluated to see if one is superior over~     the other in the maintenance of cardiac output while keeping normotension and/or treating~     hypotension experienced when receiving spinal anesthesia for cesarean delivery.~   "
73061|NCT02101034|"~     The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991~     given with cetuximab and evaluated the side effects of the combination.~   "
73062|NCT02101021|"~     There will be two phases to this study. The lead-in phase will evaluate the safety,~     pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib combined with~     nab-paclitaxel and gemcitabine in adults with previously untreated metastatic pancreatic~     ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety,~     and tolerability of nab-paclitaxel and gemcitabine combined with either momelotinib~     administered at the MTD or placebo in adults with previously untreated metastatic pancreatic~     ductal adenocarcinoma as measured by improvement in overall survival (OS), progression free~     survival (PFS), and overall response rate (ORR). Participants will continue study treatment~     until disease progression, unacceptable toxicity, consent withdrawal, or participant's~     refusal of treatment. Following treatment, participants will be followed for safety for 30~     days and for survival approximately every 3 months for up to 3 years.~   "
73063|NCT02101008|"~     Primary Objectives Determine the response rate associated with treatment of refractory~     disseminated malignant melanoma with disulfiram and chelated zinc.~      Secondary Objectives Determine the progression-free survival associated with treatment of~     refractory disseminated malignant melanoma with disulfiram and chelated zinc.~      Determine the overall survival associated with treatment of refractory disseminated~     malignant melanoma with disulfiram and chelated zinc.~      Determine the toxicity associated with treatment of refractory disseminated malignant~     melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated~     zinc on in vivo protein S-glutathionylation.~   "
73672|NCT02093026|"~     This study will assess the long-term safety and efficacy of repeating treatment with~     MabThera, in combination with methotrexate and steroids, in patients who were previously~     randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until~     Mabthera is available on the local market and the target sample size is 100-500 individuals.~   "
73064|NCT02100995|"~     The purpose of this study is to determine whether an integrated behavioral treatment~     approach can help overweight or obese individuals who also have chronic pain reduce their~     weight and manage their pain symptoms. The goal of this research is to develop better~     treatments for individuals with chronic pain and overweight or obesity. All participants in~     this study will receive treatment for weight management and/or pain symptoms. Participants~     will be assigned at random (like we picked it blindly out of a hat) to receive either: (1)~     Standard behavioral treatment for weight loss; or (2) Standard behavioral treatment for pain~     management; or (3) Integrated behavioral treatment for weight loss and pain.~   "
73065|NCT02100982|"~     The goal of this study is to develop and test Customized Care, an intervention to help~     patients dealing with depression and/or anxiety in the context of multiple chronic~     conditions. Customized Care is designed to help patients communicate about important issues,~     such as financial and safety concerns, with their primary care providers (PCPs). The~     intervention will be delivered in patient waiting rooms prior to a routine follow-up visit~     with the PCP. Phase 1 of the project will ensure that the main components of Customized Care~     are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects~     of Customized Care on patient-PCP communication.~      Participants aged 40 years or older who have a diagnosis of two or more common chronic~     medical conditions will be recruited from primary care clinics. Patients screening positive~     for either depression or anxiety will be randomized to Customized Care vs. an active~     control.~      The investigators hypothesize that the Customized Care will improve patient-Primary~     Care-Provider communication.~   "
73066|NCT02100969|"~     The purpose of this study is to determine whether Hizentra is a safe and effective treatment~     for people with myasthenia gravis (MG).~   "
73067|NCT02100956|"~     The purpose of the study is to determine the effect of oxytocin given into the spinal fluid~     on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic~     neuropathic pain.~   "
73068|NCT02100943|"~     This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the~     third trimester of pregnancy and again postpartum.~   "
73069|NCT02100930|"~     The purpose of this study is to be able to supply an experimental combination of drugs~     called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma~     who may benefit from treatment.~   "
73070|NCT02100917|"~     This study is a randomized Trastuzumab-controlled double-blind parallel-group study.~   "
73071|NCT02100904|"~     The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA~     Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF~     ablation (Acessa).~      The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone~     laparoscopic RF ablation (Acessa) within the United States. Participants will be recruited~     through study materials distributed at clinical offices across the country where~     gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will~     consent to participate in a 3 year prospective study conducted by UCSF but the laparoscopic~     RF ablation (Acessa) surgery will be performed by the study participants' own gynecologist.~     We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18,~     24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA~     (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA~     (Acessa) procedure. Participants will be asked for permission to review their medical~     records to assess surgical and pregnancy outcomes. The gynecologists performing the~     laparoscopic RF ablation (Acessa) surgery will be asked to consent to complete a brief study~     questionnaire with information on demographics, work history, professional training, and~     practice setting.~      UC San Francisco will have oversight of all scientific and administrative aspects of the~     study. All study data will be stored securely in a HIPAA compliant, secure database~     monitored by the UC San Francisco Coordinating Center.~   "
73072|NCT02100891|"~     The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study~     using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT)~     followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7~     will not only be well-tolerated in this heavily-treated population (safety), but will also~     provide a mechanism to treat high-risk solid tumors, leading to improved disease control~     rate (efficacy). Disease control rate is defined as the combination of complete (CR) and~     partial (PR) response and stable disease (SD). The investigators further propose that this~     infusion of donor NK cells will influence the development of particular NK and T cell~     subtypes which will provide immediate/long-term tumor surveillance, infectious monitoring,~     and durable engraftment.~      Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma)~     who have either measurable or unmeasurable disease and have met eligibility will be enrolled~     on this trial for a goal enrollment of 20 patients over 4 years.~   "
73073|NCT02100878|"~     Physical exercise has been shown to significantly reduce subsequent energy intake in obese~     adolescents but not in lean, without altering their appetite feelings. Although previous~     studies have pointed out the role of gastric peptides in this post exercise nutritional~     response, some recent work question the role of the neural system in the post exercise drive~     to eat. This study tends to explore whether or not an acute bout of exercise can affect the~     neural response to food cues in adolescents, obese or lean.~   "
73074|NCT02100865|"~     Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur~     in resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support~     life in these patients. Large gaps remain in the case management of children presenting to~     African hospitals with respiratory distress, including essential supportive therapies such~     as supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery,~     solar-powered oxygen, can be implemented in remote locations and will be non-inferior to~     standard oxygen delivery by compressed gas cylinders.~   "
73075|NCT02100852|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in~     combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic~     leukemia.~   "
73725|NCT02092337|"~     Computer-assisted speech training is a speech recognition training system developed for~     cochlear implant users. With minimal facilities and skills, cochlear implant users can~     conduct this training at home. The purpose of this study was to apply this system to~     adolescent and young adult hearing aid users with prelingual severe to profound hearing~     loss.~   "
73076|NCT02100839|"~     The purpose of the first part of this study is to determine the safety and tolerability of a~     single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol~     who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will~     also be evaluated.~      The second part of this study will be a multiple ascending dose evaluation of AEM-28 in~     patients with refractory hypercholesterolemia.~      AEM-28 has demonstrated significant lipid lowering activity and positive effects on the~     artery wall. AEM-28 is being developed for the treatment of homozygous familial~     hypercholesterolemia.~   "
73077|NCT02100826|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours~     will pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
73078|NCT02100813|"~     To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for~     two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily~     treatment for two consecutive days compared to vehicle~   "
73079|NCT02100800|"~     Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD).~     Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of~     COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema~     but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort~     echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging.~     Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the~     agreement between both techniques.~   "
73080|NCT02100787|"~     The objective of the study is to see if there is a change in tear osmolarity over time when~     moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.~   "
73081|NCT02100774|"~     The aim was to identify minor genetic variations (single nucleotide polymorphisms) that~     explain the interindividual variability in bioavailability of fat soluble micronutrients~     (fat soluble vitamins and carotenoids).~   "
73082|NCT02100761|"~     To investigate the relationship between cytochrome P450 (CYP) 2C19 genetic polymorphism and~     the steady-state blood concentration of voriconazole in Chinese patients with invasive~     pulmonary aspergillosis (IPA), and to assess the effects of voriconazole trough~     concentration on the prognosis of IPA patients.~   "
73083|NCT02100748|"~     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with~     placebo in patients with acute postoperative pain after bunionectomy.~   "
73084|NCT02100735|"~     The purpose of this study is to evaluate how the investigators provide sedation (medicine~     that make you sleepy) in the investigators intensive care unit (ICU). This study will look~     at a new way of using sedation in the ICU to see what effect it has on patients and if it~     decreases the amount of time spent on mechanical ventilation (machine that breathes for~     you), and in the ICU.~   "
73085|NCT02100722|"~     The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary~     pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided~     percutaneous coronary intervention (PCI) in patients with multivessel coronary artery~     disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery~     (CABG).~   "
73086|NCT02100709|"~     This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation~     on COPD patients. In particular the effect on:~        -  the amount of daily physical activity~        -  Quality of life~        -  The 6-minute walk distance~        -  Time to exacerbation~      and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive~     Ventilation as an adjunct therapy.~   "
73087|NCT02100696|"~     This phase III, double blind, placebo-controlled, multicenter study will investigate the~     efficacy and safety of etrolizumab during induction and maintenance of remission in~     participants with moderately to severely active ulcerative colitis (UC) who are refractory~     to or intolerant of TNF inhibitors.~   "
73088|NCT02100683|"~     This study is an FDA post-approval study of the Nit-Occlud PDA Device to evaluate 5 year (60~     months) safety and effectiveness of the device.~   "
73089|NCT02100670|"~     This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of~     MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in~     participants with an ankle sprain to support topical MFC51123 gel registration.~   "
73090|NCT02100657|"~     Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in~     Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory~     Multiple Myeloma.~   "
73091|NCT02100644|"~     The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by~     additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy~     patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.~   "
73092|NCT02100631|"~     Demonstrate that the vaccine offers protection based on antibody levels in older adults and~     is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.~   "
73093|NCT02100618|"~     The purpose of this study is to establish the long-term persistence of the immune response~     and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary~     study (NCT00541970).~   "
73094|NCT02100605|"~     Phytosun decongestant nasal spray is a class I medical device registered in the European~     Union for the treatment of nasal congestion. The spray contains hypertonic seawater and~     essential oils. The objective of the study is to investigate the effects of a nasal spray,~     registered as a medical device under the name Phytosun Decongestant in the European Union,~     on speed of onset of relief of nasal congestion in 50 subjects suffering from nasal~     congestion associated with common cold.~   "
73095|NCT02100592|"~     Severe brain injuries induce alteration of state of consciousness. These functional~     limitations can be significantly alleviated by treatment neurorehabilitation, particularly~     if this is established early. It has been shown that treatment of vertical integration in~     patients in a vegetative state or minimally conscious state can improve the level of~     supervision and positive influence on rehabilitation. Therefore, there are sufficient~     indications that anticipate the treatment of vertical integration, since the phase of~     hospitalization in ICUs, may improve the functional outcome of the patient.~   "
73096|NCT02100579|"~     Total knee arthroplasty is associated with intense early postoperative pain. Fast track~     recovery programs including early therapy protocols and early hospital discharge are being~     implemented at various hospitals. The postoperative analgesic pain regimen should enhance~     functional recovery in addition to providing efficient analgesia with minimal side effects.~     Adductor canal blockade is commonly used to provide postoperative analgesia for total knee~     arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor~     canal block will lower narcotic consumption and improved overall satisfaction compared to~     ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally~     invasive TKA surgery.~   "
73097|NCT02100566|"~     People with life-limiting illness often receive more aggressive healthcare than desired~     including costly procedures that provide little medical benefit. Advance Directives (AD) can~     reduce this effect but various factors limit their adoption.~      A randomized trial will target hospitalized patients with a serious, life limiting illness~     to test if the behavioral economics principles of endowment (possessing something) and~     focusing (featuring something important to patients) can motivate AD completion.~     Investigators will examine if offering patients an AD by default, in combination with~     framing the rationale for AD completion (emphasizing patient control or caregiver burden)~     improves AD completion and family conversation compared to a no-intervention group. The~     study hypothesis is to determine if rates of AD completion and family conversations will be~     highest among patients receiving the intervention focused on reduced caregiver burden; and~     if the two intervention groups will have higher rates of both than the control group.~      The investigators suspect that a small change in how patient information is framed~     (endowment and focusing used in tandem) will potentially leverage large increases in AD~     completion and that targeting HHC patients allows AD discussions early in the disease~     trajectory when they can participate in care decisions.~   "
73098|NCT02100553|"~     This study will assess if itraconazole will affect the blood levels of Duavee when they are~     given together. This study will also assess if a subject's body size affects the blood~     levels of Duavee.~   "
73099|NCT02100540|"~     Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal~     women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause~     hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is~     proposed to have effect on reduciton of hot flashes through its dopaminergic and~     serotonergic antagonism. The primary purpose of this study is to determine if RCN3028 is~     effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In~     accordance with the latest FDA guidance study participants will have a minimum of 7 moderate~     to sever hot flashes per day, or 50 per week at baseline.~   "
73100|NCT02100527|"~     This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157~     administered for 6 weeks in subjects with moderate to severe acne vulgaris.~   "
73101|NCT02100514|"~     This study is a multicenter, double-blind, randomized study to access the efficacy, safety~     and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia~     receiving background statin therapy.~   "
73102|NCT02100501|"~     The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the~     classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually~     3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven~     by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The~     modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which~     aimed to propose a less restrictive dietary treatment that would be more palatable to~     children and adolescents with less side effects. The MAD consist of a nearly balance diet~     (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the~     recommended daily calories. Some literature suggested that the MAD is an effective treatment~     for refractory epilepsy. But, no randomised controlled study has been tried. the~     investigators aimed in this prospective study to evaluate the efficacy, safety and~     tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years~     old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two~     groups; the KD group and MAD group. The patients were required to attend outpatient clinic~     after 1, 3month to record their seizure frequency and severity, while their dietary~     treatment.~   "
73103|NCT02100488|"~     Achieving near-normoglycemia has been established as the main objective for most patients~     with diabetes. However, postprandial glucose control is a challenging issue in everyday~     diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors~     to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the~     poor reproducibility of postprandial glucose response is burdensome for patients and~     healthcare professionals.~      Automatic glucose control, the so-called artificial pancreas or closed-loop system, may~     represent the ideal solution for reaching the therapeutic goals in diabetic patients.~     Intuitively, closed-loop insulin delivery may be superior to open-loop insulin delivery due~     to a better compensation of the variability of subcutaneous insulin absorption and the~     intra-subject insulin sensitivity. However, several challenges exist to effectively realize~     an optimal postprandial closed-loop control of blood glucose. Indeed, the eating process~     induces one of the major glucose perturbations that need to be controlled by an artificial~     pancreas and is currently one of the main challenges found in clinical validations of the~     few existing prototypes of an artificial pancreas. In particular, experiments carried out~     with the currently used algorithms for glucose control (the so called PID and MPC) showed~     that closed-loop insulin delivery often tend to overcorrect hyperglycemia thus increasing~     the risk hypoglycemia.~      In this project, a rigorous clinical testing of a novel closed-loop controller ('artificial~     pancreas') will be carried out in T1DM patients treated with continuous subcutaneous insulin~     infusion (CSII). The innovative element of the controller is a safety auxiliary feedback~     based on sliding mode reference conditioning (SMRC), which has been demonstrated (in~     simulation studies) to limit over-insulinization and the resulting hypoglycemia, reducing~     glycaemic variability.~      Standardized meal test studies will be performed in T1DM subjects treated with CSII,~     comparing the administration of a classical bolus (open-loop study) with a controller-driven~     prandial insulin delivery (closed-loop study) based on continuous subcutaneous glucose~     monitoring (CGM).~      The hypothesis is that closed loop control will provide better postprandial control,~     especially in terms of reduction of glucose variability and incidence of hypoglycemia.~   "
73104|NCT02100475|"~     This trial is conducted globally. The aim of the trial is to compare sequential addition of~     insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects~     with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and~     metformin and in need of further intensification.~      This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).~   "
73105|NCT02100462|"~     This will be a randomized, double-blinded, three-period crossover study of platelet~     activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone~     (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis~     is that CTD has different effects on platelet activation and aggregation than HCTZ.~   "
74015|NCT02088554|"~     To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.~   "
73107|NCT02100436|"~     This is a Phase II open-label study in approximately 240, and up to 400, healthy males and~     non-pregnant females, aged 6 months to 17 years. This study is designed to assess the~     safety, reactogenicity, and immunogenicity of two doses administered intramuscularly~     approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza~     H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age~     (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old~     and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine,~     administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In~     addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine,~     administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The~     duration of the study for each subject will be approximately 7 months.~   "
73108|NCT02100423|"~     This phase II trial studies the efficacy (activity), and tolerability of curcumin and~     cholecalciferol combination in treating patients with previously untreated stage 0-II~     chronic lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may~     prevent or slow the growth of cancer cells.~   "
73109|NCT02100410|"~     The purpose of this study was to evaluate the axis location of toric contact lenses after 3~     minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of~     various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30~     minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with~     embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens~     without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.~   "
73110|NCT02100397|"~     Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S.~     Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as~     90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi~     A, although there some candidates in preclinical and phase 1 trials. This study is funded by~     the European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a~     human-restricted infection, for which there are currently no small animal models available.~     In order to further our understanding of the host-pathogen interactions, this study will~     develop a novel human challenge model in which to investigate this infection, using a recent~     successful typhoid challenge model as its template.~      Healthy subjects to ingest a dose of Salmonella enterica serovar Paratyphi A, strain~     NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will~     establish whether each participant meets clearly defined criteria for diagnosis of~     paratyphoid infection. Statistical analysis will be performed on this outcome will determine~     if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first~     cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of~     80 participants will be enrolled. Total follow up will be over the course of one year.~     Descriptive clinical and laboratory data collected from participant observations, samples of~     blood, faeces, urine and saliva will allow insights into the disease and the host response.~     These insights will forward our knowledge of paratyphoid disease and may help discover or~     develop diagnostic methods.~      This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates~     Foundation. Paratyphoid is a human-restricted infection, for which there are currently no~     small animal models available. In order to further our understanding of the host-pathogen~     interactions, this study will develop a novel human challenge model in which to investigate~     this infection, using a recent successful typhoid challenge model as its template.~      Healthy subjects will ingest a dose of Salmonella enterica serovar Paratyphi A, strain~     NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will~     establish whether each participant meets clearly defined criteria for diagnosis of~     paratyphoid infection. Statistical analysis will be performed on this outcome will determine~     if it consistently gives an attack rate of 60 to 75%. If this is not reached with the first~     cohort of 20 participants, the dose will be escalated and the process repeated. A maximum of~     80 participants will be enrolled. Total follow up will be over the course of one year.~     Descriptive clinical and laboratory data collected from participant observations, samples of~     blood, faeces, urine and saliva will allow insights into the disease and the host response.~     These insights will forward our knowledge of paratyphoid disease and may help discover or~     develop diagnostic methods. Anticipating the development of a successful live challenge~     model through this study, there will be the possibility of evaluating novel paratyphoid~     vaccines that are currently in early clinical phase testing. This serves an important~     function because field trials in endemic areas are expensive and time consuming. Speeding up~     this process using our model will be of great benefit to endemic areas.~   "
73111|NCT02100384|"~     Nowadays, dental implants are a very attractive and affordable treatment option for~     patients. According to the American Society of Implant Dentistry the dental implant market~     in the U.S is projected to reach $1.3 billion by 20101. Despite the high success rates of~     dental implants, it is clear that osseointegrated implants are susceptible to diseases. The~     prevalence of dental implant complications are rising as the number of individuals that are~     receiving implant treatment is also increasing. One of these peri-implant complications is~     an inflammatory condition known as peri-implant mucositis that occurs in 64.6% to 80% of the~     implant population.~      The lack of preventive maintenance therapy in subjects with peri-implant mucositis is~     associated with a high incidence of peri-implantitis, which eventually may lead to implant~     loss. One important method in the prevention of peri-implant mucositis is the reduction in~     plaque accumulation, through individual oral hygiene procedures and regular peri-implant~     professional maintenance. It is highly important that patients be educated about the~     importance of developing good oral hygiene habits and to attend regular periodontal~     maintenance appointments. The clinicians have to recognize the significance of monitoring~     and maintaining peri-implant health.~      Unfortunately, it is unclear which of the different maintenance regimens and treatments~     strategies for peri-implant mucositis and peri-implantitis are more effective. There is lack~     of information about which peri-implant maintenance protocol offers the best outcome in~     terms of reduction of inflammation and improved patient comfort. According to Grusovin et~     al, there is only low quality evidence for which are the most effective interventions for~     maintaining or recovering health of peri-implant soft tissues and there is no reliable~     evidence as to which regimens are most effective for long term maintenance. Moreover,~     current approaches to implant maintenance are somewhat haphazard and not standardized.~      It is assumed that what is appropriate for teeth is also beneficial for implants; as stated~     by Persson et al, 2010 therapies proposed for the management of peri-implant diseases are~     currently based on the evidence available from the treatment of periodontitis. Two~     conventionally used methods of biofilm and calculus removal from teeth in North America are~     hand instruments (curettes and scalers) and ultrasonics. In teeth these two modalities of~     treatment have been studied extensively; conversely, there are fewer studies on dental~     implants. Renvert et al, 2008 concluded that mechanical non-surgical treatment might be~     effective to treat peri-implant mucositis but not peri-implantitis; however, the data~     supporting this literature review was scarce. The same research group compared ultrasonic~     instrumentation with specific-implant tips to titanium curettes in the treatment of~     peri-implantitis founding no group differences in the treatment outcomes with improvements~     in plaque and bleeding scores but no effects on probing depths. In addition, both methods~     failed to eliminate or reduce bacterial counts and no group differences were found in the~     ability to reduce the microbiota in a six months period.~      One of the main concerns for dental implants is that metal scalers and ultrasonics generate~     a roughened surface on the implant, which in turn facilitates plaque accumulation and~     therefore makes maintenance of plaque free surfaces more difficult. It was observed in a~     recent study that special coated scalers and ultrasonic tips have been shown in vitro to be~     compatible with implant surfaces, however this has not been confirmed in vivo. The previous~     finding is in agreement with a current study, which demonstrated that the roughness values~     of the titanium surface of implants treated with piezoelectric ultrasonic scalers with a~     newly developed metallic tip and plastic hand curettes, are equal to the surface's roughness~     of untreated implants. Mann et al, 2012 showed in an in vitro study that plastic-coated~     scalers cause minimal damage to the implant surface but leave plastic deposits behind on the~     implant surface, suggesting further research is needed to evaluate the use of such plastic~     tips in the debridement of implants.~      An additional factor, in evaluating the efficacy of different instrumentation in~     peri-implant maintenance, which needs to be taken into consideration, is patient perception.~     There is currently no data evaluating patient perception of comfort in regards to hand vs.~     ultrasonic instrumentation. This information is very important because should both methods~     of debridement be considered of equal efficacy, patient preference may play a role in the~     practitioner's selection of instrumentation. Knowing that patient comfort will increase the~     patient's compliance to the maintenance therapy, further evaluation of this factor is~     necessary.~   "
73112|NCT02100371|"~     This is an extension study of Protocol CA194002 to allow 2 specific participants with basal~     cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still~     benefitting from the study drug BMS-833923 to continue receiving the study drug. This study~     will continue to evaluate the safety and tolerability of BMS-833923 in these participants.~   "
73113|NCT02100358|"~     Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an~     accurate method of diagnosing acute cholecystitis.~   "
73114|NCT02100345|"~     Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of~     abdominal pain and suffering during women's menstrual periods. A subgroup of patients with~     DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth~     pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to~     assess the need for follow-up with transvaginal ultrasound during medical treatment.~      Hypotheses:~      Symptoms will follow growth of rectosigmoid endometriosis.~      Material and methods:~      Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and~     treatment with hormonal intrauterine device or continuous oral contraceptives will receive a~     questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion,~     (6) and 12 months later.~      Perspectives:~      Patients treated conservatively may be followed by questionnaires, thereby reducing the need~     for time consuming clinical controls.~   "
73115|NCT02100332|"~     The purpose of this study is to establish the prevalence of comorbidities in Italian~     patients with chronic bronchitis with at least 2 exacerbations per year, and to document the~     appropriateness of instrumental diagnostic tests, such as spirometry of these patients.~   "
73116|NCT02100319|"~     The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets)~     in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot~     be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other~     than azilsartan, in routine clinical practice~   "
73117|NCT02100306|"~     Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000~     cases per year in Canada. Less than half of stroke patients regain use of their arm and~     hand. There is currently no intervention regime that is the gold standard, despite the~     variety of therapeutic techniques used to treat the upper extremity post-stroke. The use of~     external feedback to improve motor learning is a technique that has been less studied but~     shows promise. Therefore, the purpose of this proof of principle study it to test whether~     different auditory feedback frequencies can facilitate reaching ability in people with~     stroke. In addition brain scans will be collected that will enable us to determine how~     stroke severity may impact on one's ability to improve with this technique.~      We hypothesize that patients who receive less feedback (50% alternate) will have enhanced~     learning relative to the patients who receive more feedback (100%).~   "
73118|NCT02100293|"~     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose~     rocuronium, intubation condition and surgical condition.~   "
73865|NCT02090517|"~     The aim of this study is to compare the efficacy of various treatment options for~     eliminating nasal telangiectasias. The study will compare the outcome of treating nasal~     telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed~     dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and~     electrosurgery.~   "
73119|NCT02100280|"~     This study is a multicenter, randomized, controlled, double-blinded, and parallel design~     study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.~     Patients are randomized to receive a deep block or a moderate block. The randomization~     numbers are generated using a computer-generated randomization code (1) and are sealed in~     the opaque envelope until they are handed over to the anesthesiologist in charge of~     anesthesia management after the induction of anesthesia. Patients, surgeons reporting the~     scale of surgical status, and another researcher analysing the cytokines levels are blinded~     to the patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective~     laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,~     hepatic or renal function impairment, on medications affecting neuromuscular function, and~     with known allergy to the drugs to be used are excluded.~   "
73120|NCT02100267|"~     The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride~     challenge test in diagnosis of adult asthma~   "
73121|NCT02100254|"~     This randomized clinical trial studies narrative or fact-based videos in increasing~     colorectal cancer screenings in African American communities. Informational videotapes may~     help increase the number of participants who engage in colonoscopy screenings. It is not yet~     known whether narrative videos may be more effective than fact-based videos in increasing~     colorectal cancer screenings.~   "
73122|NCT02100241|"~     The purpose of this study is to determine whether active stretching with low frequency~     currents are more effective than active stretching in the treatment of hamstring shortness~     syndrome in children.~   "
73123|NCT02100228|"~     Some people can develop an abnormal heart beat known as Atrial fibrillation or AF that~     puts them at risk of developing clots in the heart. Those clots can travel in the blood~     circulation to the brain and cause a brain attack (a stroke). To prevent those clots~     forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works~     by stopping one of the blood substances required for clotting (Factor Xa). It is approved~     and used to prevent clots forming in people with AF. Other established blood thinners work~     by stopping clotting substances being made, known as Vitamin K antagonists or VKAs. An~     example of this type is Warfarin (Coumadin). The good effects of all blood thinners are~     preventing clots, and they may also have bad effects of increasing the chance of bleeding.~     People with AF, abnormal heart beat, may benefit from changing it back to a normal regular~     rhythm, known medically as cardioversion. When this is done, people are currently most~     commonly treated with a VKA blood thinner (e.g. warfarin). The purpose of this study is to~     assess the good and bad effects (efficacy and safety) of apixaban compared with warfarin~     in people with AF in whom an early cardioversion is planned.~   "
73124|NCT02100215|"~     The purpose of this study is to learn more about the effects of various types of simulation~     preparation methods on novice nurses' competence and self-efficacy. Participants will be~     recruited from an academic course (N424 Integrated Practicum). Participants will be~     randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint,~     and traditional readings). All participants will complete self-efficacy surveys and two~     simulations. During simulation, participants will be scored based on their competence~     according to a performance rubric. The hypothesis is that participants in the expert~     modeling group will demonstrate more change in competence and report more change in~     self-efficacy scores than participants in other groups.~   "
73125|NCT02100202|"~     The purpose of this study is to investigate the efficacy and safety of dietary supplements~     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in~     chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.~   "
73126|NCT02100189|"~     This clinical trial studies whether esophageal cytology plus fluorescence in situ~     hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper~     endoscopy for the early detection of esophageal cancer. Genes are the units of~     deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that~     determine many human characteristics. Certain genes in cancer cells may determine how the~     tumor grows or spreads and how it may respond to different drugs. Part of this study is to~     test those genes in esophageal cells using FISH.~   "
73127|NCT02100176|"~     To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down~     the progression of the disease in Parkinson's disease (PD) de novo patients, all treated~     with Rotigotine, in a randomized controlled study with a 18 months follow-up.~   "
73128|NCT02100163|"~     The treatment of postoperative pain after severe trauma is poorly understood, and it can~     lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed~     project will be a randomized controlled trial to evaluate an innovative methodology for~     delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more~     time-honored delivery system that uses audio recordings. The goal will be to reduce~     postoperative pain in a sample of patients hospitalized for the care of severe orthopedic~     trauma. This proposal will test innovative and low-risk approaches to reducing postoperative~     trauma pain that are designed to reduce pain, anxiety and other complications after surgery.~     The findings have the potential not only to reduce pain and suffering in patients who have~     suffered severe orthopedic trauma but could be applicable to the millions of people who have~     surgery every year. Reducing addictive opiate-based medication and health care costs are~     both potential outcomes from this project.~   "
73129|NCT02100150|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of mTBI in adolescents and adults.~   "
73130|NCT02100137|"~     The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia~     diagnosed using a vaginal ultrasound during routine gynecological examination.~   "
73131|NCT02100124|"~     The purpose of this web-based study is to determine whether reproductive life planning~     (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of~     unintended pregnancy when compared to an information-only control group.~   "
73132|NCT02100111|"~     This multi-center, observational study involves reviewing the medical records of~     approximately 100 adult patients diagnosed with advanced BCC from 01 January 2005 until 31~     December 2010. All patients will be followed for a minimum of 1 year. Patient records will~     be analyzed to identify patient characteristics, treatment patterns and clinical outcomes.~   "
73133|NCT02100098|"~     The purpose of this exploratory study is to characterize the postoperative pain profile of~     patients undergoing operation with internal fixation of an ankle fracture under nerve block~     anaesthesia. Special attention is payed towards the possible existence and clinical~     relevance of a rebound pain phenomenon upon cessation of the nerve block.~      Results are used to guide the set up of a randomized controlled trial on the subject.~   "
73134|NCT02100085|"~     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6~     and E7 specific T cell response and lesion condition in subjects who have administered in~     DNA-based therapeutic vaccine.~   "
73135|NCT02100072|"~     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm~     wavelength laser for the treatment of primary hyperhidrosis of the axilla.~   "
73136|NCT02100059|"~     To determine changes in thigh muscle function and knee pain after a partial meniscectomy~     surgery and to also determine the effects of applying electrical stimulation to the knee to~     determine if this improves thigh muscle function and decreases pain.~   "
73137|NCT02100046|"~     Currently, it is established that the voltage-gated calcium channels modulate pain~     perception due to an influence on the neuronal transmission and excitability. In the past,~     attention has focused on the modulation of high voltage activated calcium channel. More~     recently, scientific interest has proven to the low voltage activated calcium channel, also~     called T-type channels. The data from the literature show significant involvement of these~     channels in the physiology of nociception and pathophysiology of acute and chronic pain.~     Moreover, in several animal pain models (acute, neuropathic, inflammatory), T-type channels~     inhibition alleviates painful behaviours.~      Analgesics treatments available in clinic are ineffective in some patients with chronic pain~     (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical~     use of selective inhibitors of T-type channels could not only help the development of new~     therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a~     pharmaco-economic impact due to the low selling price of their inhibitor currently~     available: Zarontin®.~      The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the~     pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a~     control group.~   "
73138|NCT02100033|"~     De-qi as an important factor to therapeutic effect of acupuncture for years, It's a concrete~     pathway to approach Qi, an abstract concept in Chinese medicine. However, all previous~     physicians and medical scientists have different interpretation to De-qi, and no objective~     principles for clinical practice, teaching and studies.~      Qi propagated combined with acupuncture practice always be seen as De-qi , therefore, the~     study control transmission or not and direction of sensation propagated to compare~     what's different in human body. If the change happened as prediction based on acupuncture~     theories, it could define De-qi for operation.~      The study will collect 60 subjects, from age 20 to 40, the same numbers of male and female.~     They will accept different manipulation in left hand HeGu(LI4), and assessed the variations~     in microcirculation, temperature of left forearm, and waxing/waning of yin-yang , Qi and~     blood in related meridian. We hope to understand if sensation propagated is primary factor~     of De-Qi and acupuncture effect .~   "
73139|NCT02100020|"~     The proposed project will evaluate two methods of implementation of the new Physical~     Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario~     communities. The investigators will also determine if following the PAGs will improve~     aspects of fitness, function, quality of life and risk for cardiometabolic disease in this~     population. The investigators hypothesize that adherence to the PAGs will be higher in~     people who have been referred directly to a community-based exercise program, and that this~     greater adherence to physical activity will be associated with greater improvements in~     fitness, function and quality of life.~      This randomized controlled trial will provide important information on how best to implement~     physical activity recommendations within the community setting; this information will be~     translated to key stakeholders during the final stages of the project.~   "
73140|NCT02100007|"~     The purpose of this study is to determine the safety and tolerability of ME-344 when given~     in combination with Hycamtin® in patients with solid tumors~   "
73141|NCT02099994|"~     The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate~     safety and immunogenicity of vaccines focusing T cell responses on the conserved region of~     the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and~     Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates~     electroporation.~   "
73142|NCT02099981|"~     Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of~     the disease are poorly understood. One of the earliest changes that occur in the retinas of~     diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked~     increases in blood flow in retinal vessels. The loss of this vascular response may lead to~     retinal hypoxia and it has been suggested that hypoxia could be a principal cause of~     diabetic retinopathy.~      The long-term goals of this project are to determine whether decreased blood flow in~     diabetic patients and the resulting retinal hypoxia contributes to the development of~     diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows~     or prevents the development of retinopathy.~   "
73143|NCT02099968|"~     Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated~     efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem~     to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on~     meditation or mindfulness-based interventions have shown positive effects in patients with~     hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a~     combination of diet, exercise, and stress management, have improved coronary~     atherosclerosis. However, no studies have yet investigated the effects of Comprehensive~     Lifestyle Modification in patients with metabolic syndrome and/or in combination with~     fasting therapy.~      This study is supported by a grant from the Corona-Foundation, Germany.~   "
73224|NCT02098915|"~     Infants with gastroschisis typically have poor intestinal motility for the first weeks to~     months after birth. Prokinetic agents are often used in these infants to improve intestinal~     motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to~     support this practice remains weak. Investigators hypothesize that a prokinetic agent given~     intravenously (infused into a vein) may be effective in improving gut motility in children~     with gastroschisis.~   "
73144|NCT02099955|"~     Studies have shown that individuals who have suffered a spinal cord injury are at an~     increased risk of Vitamin D deficiency compared to able-bodied individuals. It has recently~     been shown that Vitamin D deficiency is linked to a large number of diseases and conditions,~     including chronic lung disease, vascular problems, and insulin resistance. If this common~     nutritional deficiency is proven to be the cause of some of these diseases and conditions in~     persons with SCI, then it may easily be remedied with a cheap and effective therapeutic~     approach: vitamin D replacement therapy. Because of the high prevalence of vitamin D~     deficiency in persons with SCI, this therapy alone or in combination with other treatment~     options will be expected to significantly improve overall well being in the SCI population,~     decrease hospitalization rate, and the lower the financial burden of care.~   "
73145|NCT02099942|"~     This registry is designed to monitor the real world clinical performance and safety of the~     V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or~     calculations may be obtained from the imaging or evaluations already performed per the~     sites' standard of care~   "
73146|NCT02099929|"~     Epidemiological studies have shown an inverse association between coffee consumption and~     risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the~     mechanisms are limited.~      This project aims to assess the effects of coffee consumption on glucose metabolism, using~     stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on~     the reduced risk for T2DM.~   "
73147|NCT02099916|"~     Poor responders to ovarian stimulation represents one of the most frustrating problems in~     reproductive medicine. The investigators hypothesize that ovarian response of those patients~     could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to~     stimulation.~   "
73148|NCT02099903|"~     It is a randomized prospective controlled study of transcatheter renal denervation in~     patients with systolic heart failure secondary to Chagas' disease. The purpose of the study~     is to evaluate the safety and effectiveness of renal denervation in patients with Chagas~     heart disease, due to reduction in renal and systemic sympathetic activity.~   "
73149|NCT02099890|"~     Spinal cord Injury (SCI) is a condition commonly associated with a state of chronic~     low-grade inflammation due to a variety of factors such heightened risk for infection and~     development of metabolic disorders. Many disorders which have been demonstrated to have an~     inflammatory basis have also been found to be at much higher prevalence following SCI. Such~     conditions include, but are not limited to, depression, cognitive impairment, neuropathic~     pain, and somatic/autonomic nerve function. The fact that such disorders have an~     inflammatory basis provides a unique opportunity to treat them with intervention strategies~     which target the immune system. Natural anti-inflammatory interventions including a diet~     consisting of foods and supplements with anti-inflammatory properties may be an effective~     option for treating inflammation in this population. As this treatment strategy will target~     the inflammatory basis of many disorders it would be expected to lead to a reduction in~     pro-inflammatory mediators thereby leading to more sustainable long-term immune improvements~     regarding enzyme function and protein balances. Despite this, surprisingly little research~     has focused on the use of anti-inflammatory foods for the treatment of chronic inflammatory~     conditions, and effects specific to SCI have been almost completely neglected. As such, the~     current study will focus on the daily intake of natural supplements with anti-inflammatory~     properties over a 3 month intervention and the effects on inflammation and associated~     disorders will be assessed. It is hypothesized that the supplementation will result in~     positive alterations in enzyme regulation and protein balances resulting in improvements in~     each of the outcome measures of interest.~   "
73150|NCT02099877|"~     In this prospective observational double-blind study, the investigators aim to assess the~     effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G)~     on the duration of epidural fentanyl labor analgesia.~   "
73151|NCT02099864|"~     This clinical trial studies genetic and molecular mechanisms in assessing response in~     patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth~     of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount~     of androgens made by the body. Studying samples of tissue and blood in the laboratory from~     patients with prostate cancer may help doctors better understand hormone resistant prostate~     cancer. It may also help doctors make improvements in prostate cancer treatment.~   "
73152|NCT02099851|"~     This is a prospective, observational, multicenter trial to evaluate the safety and~     feasibility of selective endovascular unilateral carotid body ablation in patients with~     treatment-resistant hypertension. All patients will be followed for two (2) years following~     treatment.~   "
73153|NCT02099838|"~     Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic~     patients after treatment with SUs for 5 years, although SUs are widely used in type 2~     diabetic patients. This study was designed to evaluate the effectiveness and safety of~     adding compound preparation of pioglitazone and metformin for type 2 diabetic patients who~     have bad glycemic control with the initial treatment of SUs.~   "
73154|NCT02099825|"~     The purpose of this research study is to determine whether taking a one-time dose of a~     combination of putatively learning-enhancing medications can improve treatment response to a~     brief learning-based psychotherapy for public speaking anxiety. The two medications are (1)~     d-cycloserine (DCS), a medication that is an agonist (facilitator) of the NMDA glutamatergic~     receptor and has been shown in previous studies to facilitate some kinds of learning and~     memory; and (2) mifepristone, a medication that blocks cortisol, and in preclinical (animal)~     studies has been shown to reverse certain kinds of stress-related learning impairment or~     negative learning.~      Specifically, the investigators goal is to determine if DCS and mifepristone taken together~     augment the learning that occurs during a brief psychotherapy session---a public speaking~     exposure exercise. Evidence for this learning effect would be a finding that participants~     have reduced anxiety at subsequent public speaking exposures.~   "
73255|NCT02098512|"~     Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard~     of care reduced intensity regimen and an allogeneic stem cell transplant (from another~     person, related or unrelated). Following recovery, patients will receive a medication called~     Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that~     this treatment will be safe and well tolerated in children and young adults.~   "
73155|NCT02099812|"~     Low socioeconomic status (low SES), as defined by educational attainment and income, has~     been associated with obesity in industrialized nations. Low SES has been related to~     impulsive decision-making characterized by steep devaluation of future outcomes (delay~     discounting, DD) and a greater motivation to obtain food (food reinforcement, FR). DD and FR~     have been shown to interactively predict ad libitum energy intake in laboratory studies,~     such that participants exhibiting high FR as well as high DD consume the most food. Obesity~     often results from energy intake in excess of physiologic needs, and thus a plausible~     mechanism is that low SES environments increase FR and DD, leading to overeating and~     obesity. The primary aims of this study are to determine whether FR and DD interact to~     predict BMI, and whether differences in FR and DD mediate the relationship between low SES~     and obesity, in a large sample of US adults of varying BMI. In addition, whether high FR and~     high DD are related to unhealthy food purchasing and eating behaviors will be assessed. It~     is anticipated that high FR and DD will be related to unhealthy food purchasing and eating~     behaviors.~   "
73156|NCT02099799|"~     COPD currently afflicts 24 million US residents; the prevalence of COPD is high among~     Veterans. Persons with COPD have significant functional disability as a result of the~     disease. This project will determine whether a novel Internet-mediated walking program~     coupled with a pedometer can improve exercise capacity, improve health-related quality of~     life, and decrease the risk of acute exacerbations in persons with COPD. If successful,~     based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise~     intervention could help over 8 million persons. The Veterans Health Administration (VHA) has~     a strong commitment to providing care to persons with COPD and supporting research directed~     at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and~     Development includes research in COPD rehabilitation. The proposed research addresses~     Rehabilitation R&D Service's current priority area of improving disabled Veterans'~     health-related quality of life by reducing disease burden and maximizing functional~     recovery.~   "
73157|NCT02099786|"~     This study involves research. Some chemotherapeutic drugs that can permanently reduce~     hearing are termed ototoxic. One such drug is the chemotherapy called cisplatin.~     Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic~     using lengthy protocols and may be retested only when it is requested by their oncologist~     and when the Veteran can arrange an appointment. Researchers think that hearing testing~     prior to every treatment of cisplatin may reduce the number of Veterans who get disabling~     hearing loss from treatment. The purpose of this study is to compare the current method of~     monitoring hearing (audiology clinic protocols termed usual care) with a new portable~     hearing monitoring program (a comprehensive program of ototoxicity monitoring termed~     COMP-VA) that tests hearing using a portable hearing testing audiometer and a variety of~     efficient tools and techniques so that testing can occur prior to each cisplatin treatment~     at any quiet location in the hospital.~   "
73158|NCT02099773|"~     This exploratory and observational study focuses on adults with an intellectual disability~     (ID) and their support workers. Two groups of clients are observed: clients using Key Word~     Signing, and clients using aided Augmentative and Altenrative Communication (AAC).~     Approximately half of adults with ID is estimated to experience communication difficulties.~     AAC supports them in their daily communication aiming at optimal participation in society.~     Current communication models, such as Participation Model (Beukelman & Mirenda, 2005) and~     International Classification of Functioning, Disability and Health (WHO, 2001), regard both~     client-related and environmental factors as important elements of communication. A~     substantial part of the environmental factors is made up of the communication partners'~     characteristics. In daycare and residential services for adults with ID the support worker~     is an important communication partner .~   "
73159|NCT02099760|"~     The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in~     rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples~     obtained from the pharynx is exploratory and will provide new information on the frequency~     of pharyngeal infection due to CT and GC.~      A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal~     and rectal samples using both the Xpert system and AC2 to assess whether women positive for~     this pathogen rectally usually or always have vaginal infection due to this pathogen.~      The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification~     testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting~     Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG~     will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis~     and Neisseria gonorrhoeae in rectal samples.~   "
73160|NCT02099747|"~     The null hypothesis of no difference in CR% at 3 months between the arms will be tested~     against the alternative of a difference in CR% at an alpha level of .05 by assessing the~     odds ratio for arm yielded by this model.~   "
73161|NCT02099734|"~     This study is being done to create a registry to help us learn more about germ cell tumors~     (GCT) and other testicular tumors. The registry will include people with these tumors and~     also relatives and unrelated people without these tumors. This study will help us learn more~     about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives~     of patients and people unrelated to patients with GCT and other testicular tumors will help~     us understand why some people get these tumors and why some people don't.~   "
73162|NCT02099721|"~     The purpose of this study is to demonstrate that primary prevention patients with one or~     more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained~     ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left~     ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular~     arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar~     benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization~     therapy- defibrillator (CRT-D) implant.~   "
73163|NCT02099708|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of lansoprazole (Takepron) therapy for up to 12 months in the routine~     clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)~   "
73164|NCT02099695|"~     Treatment of primary hyperhidrosis through a comparative study between oxybutynin~     hydrochloride and placebo.~      Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of~     life.~   "
73166|NCT02099669|"~     Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone~     marrow function that may progress to acute myeloid leukemia. Many patients become red blood~     cell transfusion-dependent. Transfusion dependence is associated with inferior quality of~     life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A~     commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90~     g/L (normal hemoglobin > 120-130g/L). The question is: would a higher hemoglobin target lead~     to improvement in QOL despite the negative impact transfusion dependence may have on QOL~     (due to associated time commitments, expense, transfusion reactions etc). Several groups~     have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with~     hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of~     15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program~     has been conducting prospective assessments of QOL since 2007 in all registered and~     consented patients using a variety of validated questionnaires. Preliminary analysis (in 236~     patients) revealed that, compared with an age-matched healthy general population, MDS~     patients have inferior QOL. Transfusion dependence and anemia were independently predictive~     of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level~     of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores.~     The investigators hypothesize that the target hemoglobins in transfusion dependent MDS~     patients are too low and this may account for their inferior quality of life. Our goal is to~     compare the effect on QOL of a restrictive strategy (which is the current standard of care),~     with a liberal transfusion strategy in a large randomized controlled trial of transfusion~     dependent MDS outpatients. Before embarking on such an endeavor, the investigators must~     first prove feasibility in a smaller pilot randomized controlled trial.~   "
73167|NCT02099656|"~     This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate~     the effects of lebrikizumab on airway eosinophilic inflammation in participants with~     uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second~     controller medication. Enrolled participants will undergo a 3-week screening period during~     which assessments, including a bronchoscopy procedure, will be made. Participants will~     subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection~     on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care~     therapy throughout the study. End of treatment assessments will be taken at Week 12. Total~     study period, including screening and follow-up, is expected to last 23 weeks.~   "
73168|NCT02099643|"~     Recent data has demonstrated that focal sources are determinant in human atrial fibrillation~     (AF) perpetuation.~      The investigators sought to identify crucial areas for AF perpetuation during our routine~     electrogram (EGM)-based substrate ablation.~   "
73169|NCT02099630|"~     The study will investigate functional and metabolic changes in the course of antidepressive~     treatments.~      The investigators will apply different imaging methods to investigate the effects of~     antidepressive interventions on resting state neural activity, functional activation during~     cognitive and emotional stimulation, neurotransmitter concentrations as well as~     concentrations of brain- derived neurotrophic factor.~   "
73170|NCT02099617|"~     The main objective of the SENIOR study is to establish the efficacy and safety of the~     everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with~     a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable~     angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related~     to significant coronary artery disease and requiring percutaneous coronary intervention. The~     primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated~     with a lower rate of the composite rate of major cardiovascular and cerebrovascular events~     (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion~     revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.~   "
73171|NCT02099604|"~     The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D~     followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with~     standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the~     sustained virological response (SVR) at 3 months after end of treatment (week 60).~   "
73172|NCT02099591|"~     To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through~     population PK in paediatric patients with opioid induced constipation (OIC).~   "
73173|NCT02099578|"~     Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that~     approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major~     modifiable risk factor for CVD and approximately 60% of adults in the US are~     pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated~     with aging in both genders; however, the increase in blood pressure (BP) in women after~     menopause exceeds that of men.~      The development of effective and safe strategies to improve vascular function is of~     significance as it can have a great impact on quality of life, productivity and economic~     burden for the affected populations. One such alternative would be to introduce into the~     diet food sources that are rich in naturally occurring bioactive compounds. Thus, the~     long-term goal of the investigators is to provide feasible and effective dietary ways for~     postmenopausal women to improve their vascular function and quality of life.~      Strawberries are a rich source of bioactive compounds and its total antioxidant content~     ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring~     forth evidence that incorporation of strawberries into the diet will reduce blood pressure~     and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.~      Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥~     130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of~     three groups:~        1. 25 g freeze-dried strawberry powder;~        2. 50 g freeze-dried strawberry powder; or~        3. placebo powder. Participants will be asked to consume the supplements for 8-weeks.~          Medical history, medication use, dietary intake, and physical activity will be assessed~          at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of~          cardiovascular function as well as oxidative stress and inflammation will be measured.~      The investigators hypothesize that regular consumption of strawberry will improve~     cardiovascular function, decrease BP and blood markers of oxidative stress as well as~     inflammation. Investigators also expect the findings of this study to provide a foundation~     for further studies to examine the effects of long-term incorporation of strawberry into the~     diet and the integrity of cardiovascular system.~   "
73174|NCT02099565|"~     The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular~     and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in~     OPTIMA study. In addition, the long-term effects of statins on LDL-cholesterol and different~     biomarkers in patients after drug-eluting stents implantation will be assessed. In addition,~     such project implementation will allow to clarify the treatment options used by Russian~     patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The~     information received in this study will help to optimize management of Russian patients with~     CAD after PCI in order to improve prognosis and quality of life of these patients.~   "
73175|NCT02099552|"~     The proposed natural history study will enroll male and female patients, ages 36 months and~     younger, who have a diagnosis of XLHED based on genetic testing and who have not received an~     investigational study drug. The study protocol will include collection of all relevant~     medical history and documentation of clinical outcomes using age-appropriate, minimally~     invasive technologies. Data will be collected both retrospectively, back to pregnancy~     assessments that may be available, and prospectively through age 5 yrs.~   "
73177|NCT02099526|"~     The goals of the study are to investigate the needs of older (age 60+) caregivers caring for~     adults with cancer at 1-week and 2 weeks following hospital discharge and to explore~     strategies that may assist caregivers in their home caregiving needs. This study will~     explore how these needs vary based on caregiver spirituality and relationship with the care~     recipient.~      The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which~     are the hematological and non-hematological malignancy units at Duke University Medical~     Center (DUMC) respectively. Results of this study will lay the groundwork for creating~     tailored interventions for caregivers that are compatible to their preferences and more~     responsive to their needs.~   "
73178|NCT02099513|"~     This study develops and pilots the initial interface of our mobile health platform that will~     allow for intra-individual tailoring and personalization of health interventions. This will~     allow for just-in-time interventions that adapt both the content and timing, not just~     initially, but also over time based upon prior outcome data, responses to an intervention,~     current environmental and social context, activity level, location, time, and an~     individual's psychophysiological state.1,2~      Aim 1: To develop the initial interface of the mobile health platform that will allow~     patients to report and receive data representing multiple health domains including blood~     pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep,~     and self-report survey measures such as pain and fatigue.~      Aim 2: To assess feasibility of the mobile health platform to receive and deliver data~     representing multiple health domains over 1 month through a single-case study design (N=6).3~     Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate~     adaptive work by providing patients with automated real time feedback on their progress.~      Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will~     facilitate adaptive approaches by alerting clinicians on the progress of their patients.~   "
73179|NCT02099500|"~     This is an open-label, non-randomized, multi center, patient sponsored study of~     Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who~     have critical limb ischemia not amenable for revascularization.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived~     tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the~     adipose tissue specimen. The adipose tissue is then transferred to the laboratory for~     separation of the adipose tissue derived stem cells. In addition, peripheral blood will be~     collected for isolation of platelet rich plasma, which are then combined with the ASC's for~     intramuscular injection into the lower limb.~   "
73180|NCT02099487|"~     To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide~     on survival and quality of life in elderly, poor performance status patients with newly~     diagnosed HGG.~   "
73181|NCT02099474|"~     The purpose of this study is to assess the evolution of raltegravir concentration in the~     mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate,~     when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined~     antiretroviral regimen.~   "
73182|NCT02099461|"~     To evaluate whether administration of denosumab results in a decrease compared to the~     control group in proliferation of mammary epithelial cells as measured by the Ki-67~     proliferation index.~   "
73183|NCT02099448|"~     The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP~     using the investigational device C.A 2.0.~   "
73184|NCT02099435|"~     This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower~     gastrointestinal bleeding.~   "
73185|NCT02099422|"~     Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting~     for ACS. Efficiency and tolerance évaluation~   "
73186|NCT02099409|"~     The purpose of this study is to validate current algorithms and evaluate safety and efficacy~     of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1~     diabetes between 6 - 12 years of age in Luxembourg .~   "
73187|NCT02099396|"~     The purpose was to evaluate efficacy, safety and effects on survival for lobaplatin and~     Gemcitabine in combination with Docetaxel, which can provide a kind of completely new~     second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide~     accurate and reliable evidence-based results for clinical applications of lobaplatin in~     osteosarcoma patients as one of the third-generation of platinum drugs, and further~     consummate and enrich clinical practice guidance on osteosarcoma all over the world.~   "
73188|NCT02099383|"~     The investigators' preliminary findings suggest that providing patients with acute ischemic~     stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the~     occurrence of stroke-in-evolution(SIE) and therefore improve prognosis.~      The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution~     72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based~     hydration therapy. Part 2, The investigators use two outcome measures, including Barthel~     index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio~     based hydration therapy results in sustained clinical benefit at three months.~   "
73189|NCT02099370|"~     The investigators are measuring the adherence rates of an oral MS drug that is to be~     administered twice-daily. The investigators would like to observe any patterns that might~     indicate factors that greatly affect adherence.~   "
73190|NCT02099357|"~     The purpose of this study is to determine the effects of creatine monohydrate or vitamin D~     supplementation on strength gains following a traditional resistance training program for~     adults with spinal cord injury.~   "
73191|NCT02099344|"~     Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs~     better than the other. How long each one lasts until a complication arises or until the~     graft is no longer used will be compared.~      The study hypothesis is that the Artegraft, being an actual blood vessel, will work better~     than the manufactured Propaten graft.~   "
73280|NCT02098187|"~     The purpose of this early feasibility study was to investigate the pharmacokinetics of~     MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function~     Monitor (ORFM), an investigational noninvasive fluorescence detection device.~   "
73192|NCT02099331|"~     Atrial fibrillation is a common heart rhythm condition that can occur after cardiac surgery~     and has been associated with an increase in hospital length of stay, overall hospital costs,~     worsening clinical condition and higher rates of death. Newer research indicates that~     inflammation is a key contributor to atrial fibrillation in this setting.~      Melatonin is a naturally made hormone that is regarded as an extremely effective~     anti-inflammatory substance, with a very favorable safety profile. This clinical trial is~     being done to test the ability of melatonin to reduce the risk of developing atrial~     fibrillation after cardiac surgery.~      This is a research study where patients will be given either oral melatonin at 40 mg or~     placebo nightly prior to sleep. The study product will start approximately 2 days prior to~     the scheduled surgery date and will continue until the 3rd day after the operation. The~     remainder of the clinical care will remain the same.~      The investigators project that patients who receive melatonin will have a significant~     decrease in the occurrence of atrial fibrillation after surgery.~   "
73193|NCT02099318|"~     Objectives: The objective of this clinical study is to determine if the use of the SRP will~     lead to improved effort and time efficiency in cerebral aneurysm surgery. For this~     preliminary study, the investigators will assess key time and effort variables associated~     with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP~     rehearsal. This is a single site study with one enrolling site. This study will include a~     total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly~     selected according to a predetermined alternating sequence.~   "
73194|NCT02099305|"~     The primary goal of the proposed research is to assess the effectiveness of the Adolescent~     Depression Awareness Program (ADAP), a school-based depression education program, in~     increasing depression literacy and treatment seeking in high school students. The ADAP~     intervention will be carried out in approximately 60 schools with over 15,000 students. The~     following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle~     County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.~   "
73195|NCT02099292|"~     The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM~     (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy~     in patients with relapsed/refractory aggressive and indolent lymphoma.~   "
73196|NCT02099279|"~     Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is~     a major reason for ICU admission. Cardiac function is often impaired in this disease but its~     association with clinical outcome has not been fully established. The study aims to~     investigate the association between cardiac dysfunction and clinclial outcomes.~   "
73197|NCT02099266|"~     By doing this study, researchers hope to learn the following:~        -  If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)~          transplant will help to improve the homing process~        -  The safety of HBO administration in the setting of the UBC transplant~        -  The effects of HBO therapy on the engraftment process~   "
73198|NCT02099253|"~     Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its~     selectivity for α2 receptor is 1600 times higher than α1.It also could provide~     dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and~     other effects .At earlier time It was approved by the FDA only for short-time sedation~     during mechanical ventilation of adult patients (<24h) in ICU. Because of its minimal impact~     on the respiratory , currently it was more and more widely used to sedate patients~     undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are~     often affected by age and gender,such as the drug sensitivity of propofol and remifentanil~     is increased with age,while the current study also demonstrated that gender may influence~     the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current~     studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are~     rare. The study is aim to explore the right DEX dose of different Age of patients to produce~     suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural~     anesthesia for sedation,which is monitored by the BIS,during the operation.The relation~     between BIS values and the depth of sedation for patients is also investigated.~   "
73199|NCT02099240|"~     Based on the current literature, investigators hypothesize that patients with osteomyelitis~     who are treated with the standard approach of intravenous antibiotics for the full duration~     of therapy will have the same clinical outcomes as patients treated with the experimental~     approach of intravenous antibiotics with early switch to oral antibiotics.~      The primary objective of this study is to compare patients with osteomyelitis treated with~     the standard approach of intravenous antibiotics for the full duration of therapy versus~     patients treated with intravenous antibiotics with an early switch to oral antibiotics in~     relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy.~     Secondary objectives of the study include the evaluation of adverse events related to the~     use of antibiotics as well as the cost of care evaluated from the hospital perspective.~   "
73200|NCT02099227|"~     To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric~     skin and soft tissue infections treatment failure rate, as well as emergency department~     process outcome.~   "
73201|NCT02099214|"~     Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible~     first for biological disorder in blood iron parameters and minor clinical disorders, before~     evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and~     congestive heart failure.~      The improvement of screening and treatments made those severe affections rare enough not to~     evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless~     this myocardial iron overload might have severe implications on cardiac function on a long~     term basis.~      A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed~     a myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.~      The main objective of this study is to precisely estimate cardiac iron overload in treatment~     naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more~     sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac~     morbidity in HHC.~   "
73281|NCT02098174|"~     The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg)~     compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in~     healthy adult participants. The secondary objective was to evaluate the safety and~     tolerability of MP-3180 in healthy adult participants.~   "
73202|NCT02099201|"~     This is a single-center, double-blind, parallel-group, randomized, placebo-controlled,~     multiple-ascending oral dose study to investigate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy subjects.~      Part A of the study will evaluate the safety and tolerability following once a day oral~     dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and~     pharmacodynamics.~      Part B of the study will evaluate the safety and tolerability of ACT-389949 following a~     maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13~     days or every 2 days for 9 days (5 doses for each regimen).~      Part C of the study, if required, will provide additional information to that obtained from~     Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of~     ACT-389949.~   "
73203|NCT02099188|"~     Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For~     patients with inoperable tumors, the prognosis is poor and the current therapy is a~     combined-modality treatment that is both more effective and associated with less morbidity.~      This study proposes innovative integration of multiple modality of treatment modulated by~     histology, molecular profile and response to induction CT.~   "
73204|NCT02099175|"~     Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has~     been reported, given rarity, absence of prospective study and heterogeneity of histologies~     and stages of diseases. This study proposes innovative integration of multiple modality of~     treatment depending by histology, molecular profile and response to induction CT. Moreover,~     such strategies allows the use of latest technology with greater biological effectiveness~     and reduction of toxicities.~   "
73205|NCT02099162|"~     Optical coherence tomography (OCT) has been recently studied for evaluation of coronary~     stenting. Because of high resolutions, several reports have shown that OCT is appropriate~     for evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage~     and the characterization of neointimal tissue can be accurately evaluated. Furthermore,~     OCT-defined coverage of a stent strut was proposed to be related with clinical safety in~     drug-eluting stents-treated patients. Therefore, we will evaluate the appropriateness of~     currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent,~     Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial~     progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, we will~     evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in~     the stent characteristics, the duration of antiplatelet use, and the differences according~     to the clinical presentations.~   "
73206|NCT02099149|"~     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers~     and their infants who develop disease versus those who do not. Use this comparison to~     establish antibody levels associated with reductions in risk of GBS disease in infants aged~     less than 90 days.~   "
73207|NCT02099136|"~     This randomized clinical trial studies if celecoxib will prevent the damaging effects of~     sunburn in healthy volunteers. Exposure to ultraviolet light can induce erythema, sunburn or~     skin redness caused by inflammation. Celecoxib may reduce skin damage by blocking enzymes~     associated with sunburn in healthy volunteers. Studying samples of skin in the laboratory~     from patients receiving ultraviolet-radiation before and after celecoxib treatment may help~     doctors learn more about the effects celecoxib has on cells.~   "
73208|NCT02099123|"~     The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared~     with placebo will prolong overall survival or disability free survival amongst healthy~     elderly people (≥70 years).~   "
73209|NCT02099110|"~     This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin~     given together or alone along with metformin in participants with type 2 diabetes mellitus~     (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of~     this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater~     hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.~   "
73210|NCT02099097|"~     The purpose of this study is to develop and test a web-based game called Quit It that is~     designed to help smokers who have quit smoking cope with any smoking urges they may have.~     The purpose of the game is to help people quit and stop people from smoking again.~   "
73211|NCT02099084|"~     This research study was done to see what the effects are of Teduglutide on people with short~     bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection,~     which has shown to increase intestinal blood flow, inhibit gastric secretion, increase~     growth of intestinal cells and increase absorption of nutrients. Teduglutide has~     demonstrated to decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide~     is approved by the Food and Drug Administration (FDA) for the treatment of adult patients~     with Short Bowel Syndrome (SBS) who are dependent on parenteral support.~      The primary hypotheses for this study were 1) that Teduglutide significantly increases the~     gastric emptying half time of solids when compared to placebo. 2) Teduglutide will~     significantly decrease the intestinal permeability and urinary excretion of lactulose when~     compared to placebo.~   "
73212|NCT02099071|"~     This is a prospective, single-center, double-blind, randomized, placebo-controlled,~     ascending single oral dose and food interaction Phase 1 study. It will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of~     ACT-389949 in healthy male subjects. It will also investigate the effect of food on the~     pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.~   "
73213|NCT02099058|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABBV-399 in subjects with advanced solid tumors.~   "
73225|NCT02098902|"~     The purpose of this study is to test the effect of a novel six-month behavioral program to~     reduce sugar-sweetened beverage consumption among preschoolers and their mothers. The~     behavioral intervention tested will be delivered via a mobile-based website, text messages~     and email in addition to one face-to-face group meeting. The intervention will be compared~     to a waitlist control group. Participants will be 42 overweight/obese mothers and their~     children ages 3-5 living in the Chapel Hill/Raleigh/Durham area. Sugar-sweetened beverage~     consumption and weight in both children and mothers will be measured at three- and~     six-months post-randomization. It is hypothesized that children randomized to the~     intervention will have a greater reduction in sugar-sweetened beverage consumption at 6~     months compared to children randomized to the control group.~   "
73214|NCT02099045|"~     Background: It is well known that emergency physicians can conduct ultrasound examinations~     as a supplement to initial physical examination. No previous studies have been conducted to~     evaluate the total findings with ultrasound on a broad unselected group of patients in the~     Emergency Department.~      Aim: We aim to identify the pathology found in an unselected cohort of patients in a Rural~     Emergency Department. Secondarily we aim to quantify the changes done in treatment as a~     result of the ultrasound examination performed bedside in the Emergency Department.~      Hypothesis: Supplemental ultrasonographical examination will change diagnostics and~     treatment in 10 % of an unselected cohort of patients in the Emergency Department.~      Method: We will perform a structured ultrasound examination of 406 patients on an unselected~     cohort in the emergency department. All patients age 18 years and above presenting in the~     emergency department will be included in the study. Patients unwilling to give informed~     consent will be excluded from the study. Patients will be excluded if the ultrasonographic~     examination cannot be performed within the first two hours after initial contact with the~     treating physician. The study will be conducted in two substudies. Sub study 1 including all~     patient legally competent to give informed consent. Sub study 2 including all legally~     incompetent patients who cannot give informed consent due to acute illness. These patients~     will be included in the study under the rules of emergency research.~      After including the patients we will ask the treating physician a series of binary questions~     regarding diagnosis and treatment plan.~      Outcome: Primary outcome is the pathology found by ultrasound in the department. Secondary~     outcome will be the changes in diagnosis or treatment plan. Pathology and changes in~     diagnosis/treatment will be stratified according to initial complaint, triage level, age and~     other factors. This has never been done on unselected patients in the Emergency Department.~      Ethical considerations and adverse effects: Ultrasound transmits high frequency waves into~     the tissue, which is reflected to the ultrasound probe. The time and magnitude of the~     returning sound waves are interpreted into picture on the screen. No adverse effects have~     been reported on the basis of the sound waves transmitted through the tissue.~      Some patients might experience discomfort due to the sticky sensation from the application~     of ultrasound gel. Others might experience discomfort from the pressure applied to the probe~     under the imaging. Adverse effects, which we are not aware of, may exist. However, clinical~     ultrasound has existed since the 1950'ies and new adverse effects are unlikely.~      Publication: All results will be published in international peer-review journals. Also in~     the event of inconclusive results.~   "
73215|NCT02099032|"~     Polar lipids have a specific chemical structure: they are an essential component of human~     cell membranes, play a major role in the nervous system and also influence the metabolic~     pathways including the cholesterol metabolism.~      Polar lipids are used in food-processing industry for their emulsification properties. The~     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers~     such as polar lipids.~      The purpose of this research is to study plasma cholesterol variation after daily intake of~     milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of~     cheese product during four weeks instead of their usual cheese products.~      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine~     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).~   "
73216|NCT02099019|"~     As the prospective, observational, cross-sectional study, the accuracy of CT~     angiography-based therapeutic decision-making for revascularization will be evaluated. The~     primary objective of this study is to evaluate the accuracy of CT angiography-based~     therapeutic decision-making for revascularization prior to conventional angiography whether~     CT angiography is an accurate non-invasive technique to determine the most appropriate~     therapeutic strategies.~   "
73217|NCT02099006|"~     This study is testing drugs not previously used topically for the treatment of vulvodynia, a~     common genital pain syndrome. It is hoped that one of these drugs will improve vaginal~     entryway pain with touch, daily pain scores and sexual functioning.~   "
73218|NCT02098993|"~     The purpose of this study is to determine the feasibility of performing a larger multicenter~     phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest~     syndrome (ACS). Prespecified feasibility criteria consists of the ability to enroll~     potential study participants, which includes the timely notification of hospitalized~     patients with ACS, the capacity to consent eligible individuals, and the ability to~     appropriately randomize eligible patients within 24 hours of diagnosis. Additional~     feasibility objectives involve ensuring appropriate eligibility criteria, proper~     administration of the study drug, and the ability to completely and accurately collect~     clinical data of interest. The final aim of our pilot study is to provide preliminary data,~     with respect to treatment effect and variance, to allow sample size calculation in a larger~     trial given the lack of data available to help guide this process. The investigators~     hypothesize that the use of UFH in ACS will result in a decrease in the duration of~     hospitalization and improve other clinical outcomes, such as the duration of hypoxemia and~     duration of moderate to severe pain.~   "
73219|NCT02098980|"~     There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum~     levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose~     tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is~     that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will~     decrease insulin resistance and the associated metabolic indices linked to the later~     development of T2DM.~   "
73220|NCT02098967|"~     This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior~     to investigations in either arm, patients in a single cohort, Cohort 0, will receive~     non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle.~     Interim PK and safety data from this cohort will be evaluated before initiating~     dose-escalation.~      In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm~     B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia~     (AML). The arms will escalate independently. Escalation will begin in solid tumor patients~     (Arm A) in single patient cohorts, using a new Continual Reassessment Method (n-CRM).~     Escalation for AML patients will be initiated at or below the dose level that causes >/=~     Grade 2 hematologic side effects in Arm A. Escalation in AML patients will follow a rolling~     6 design.~      In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles.~      There will be no intrapatient dose escalation. All patients may be treated until disease~     progression/relapse or unacceptable toxicity.~   "
73221|NCT02098954|"~     Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of~     non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or~     secondary resistance will be developed after TKI treatment, doctors do plenty of researches~     to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined~     with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR~     sensitive mutations, several study shows that sensitive mutations still exist after TKI~     resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at~     present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese~     patients could not support. Thus, the investigators hypothesis that, after first line TKI~     treatment, the patients who developed TKI resistance could still benefit from second line~     TKI combined with chemotherapy.~   "
73222|NCT02098941|"~     The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam~     and oxcarbazepine in a long term epilepsy treatment.~   "
73282|NCT02098161|"~     To goal of this clinical research study is to learn if LCL161 can help to control~     myelofibrosis. The safety of this drug will also be studied.~   "
73226|NCT02098889|"~     Although Hyoscine N butyl bromide (HBB) is used liberally to facilitate cervical dilatation,~     there is little and inconclusive data about its efficacy. The aim of this study was to~     determine the efficacy and safety of HBB on the augmentation of labor.420 of total 1640~     pregnant women admitted to the investigators clinic (Sisli Ethal Training and Research~     Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 37-41~     gestational weeks, active phase (cervical dilatation: 4 cm, cervical effacement: %50 or~     more) of spontaneous labor with vertex presentation enrolled to study. 382 of them were~     included in this study. Patients were randomized to receive intravenously(IV) either 20~     mg/ml HBB or a similar amount of placebo (1 ml 0.9% NaCl) at the beginning of the active~     phase of labor. The medications applied as single dose. The time elapsed until the second~     stage of labor, second stage and third stage were measured.~   "
73227|NCT02098876|"~     Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction~     and restore blood flow to the heart muscle. Stents could also be coated with a drug~     (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue~     within the vessel that otherwise could lead to re-narrowing. This study will evaluate the~     effects of 2 FDA-approved metallic stents with different designs that may have important~     effects on regional plaque response and blood flow dynamics immediately after stent~     deployment and stent healing at 12 months follow up.~   "
73228|NCT02098863|"~     Despite the important work of previous sickle cell disease (SCD) cohort studies, there~     remain many understudied areas that require investigation. An important knowledge deficit is~     the slow but progressive process of chronic end-organ dysfunction. The majority of organ~     dysfunction becomes apparent in the young adult years, but comprehensive assessment of~     adults and understanding of predictors of adulthood organ dysfunction are insufficient.~     Similarly, the role of disease-modifying therapies, such as hydroxyurea, in preventing organ~     dysfunction later in life is not clear. Extended follow-up of patients through the~     transition into adulthood is imperative to understand the long-term implications of~     pediatric sickle cell care.~      This observational study will collect data in a systematic fashion at participants' regular~     clinic visits to answer the objectives described below.~   "
73229|NCT02098850|"~     The purpose of this evaluation is to record the management and outcome of adults with~     S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to~     identify key quality indicators associated with improved outcome.~   "
73230|NCT02098837|"~     The purpose of the study is to investigate the benefits of switching away from a kind of~     drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients'~     cardiovascular health (the health of their hearts). Patients are currently taking two other~     anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their~     boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the~     boosted PI and dolutegravir more accurately, half of study participants will be switched to~     dolutegravir immediately, and the other half will be switched after 48 weeks of continuing~     on the boosted PI.~      Boosted PIs are associated with increased heart and circulation risk so it is hoped that~     switching from a boosted PI to dolutegravir will improve the health of the patients' hearts.~     Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in~     the US and Europe. Clinical trials using dolutegravir have found that it is effective at~     suppressing the HIV virus, and it is at least as effective as the other drugs.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which the investigators ordinarily use to monitor patients' treatment) and~     monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment~     from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in~     their blood, and CD4 count is a measure of a type of cell that is in their immune system. We~     also aim to improve patients' cardiovascular health in general by providing them with~     information on how to live a healthy lifestyle (eg improving their diet, stopping smoking~     etc).~   "
73231|NCT02098824|"~     Single center threeway double blind cross over trial investigating the pharmacological~     responsivity in patients with VCI using a challenge aimed at the monoaminergic and~     cholinergic neuronal systems~   "
73232|NCT02098811|"~     The purpose of this study is to evaluate and compare the safety and efficacy of a~     non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue~     and skin tightening.~   "
73233|NCT02098798|"~     We propose a randomized controlled study to determine the detection rates of neoplasia with~     high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High~     definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years~     from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis)~     CD or UC.~      We hypothesized that these novel endoscopic techniques using High definition colonoscopy~     with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy~     alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and~     neoplasia in patients with long standing IBD.~      We will aim to demonstrate if we can avoid dye spraying during the procedure and save~     expense and considerable time.~      In addition, we can hope to produce evidence and inform the way in which we perform~     surveillance colonoscopy especially without large number of multiple random biopsies but~     only few targeted smart and intelligent biopsies using high definition colonoscopy with~     iSCAN technique as is already the European practice in several centres.~   "
73253|NCT02098538|"~     Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if regorafenib is a~     useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been~     approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an~     experimental drug that has not yet been approved for use in adenoid cystic carcinoma.~      In this study, the patient will initially be treated with a dose of regorafenib that is~     lower than what the FDA approved for other cancers in an attempt to decrease the risk of~     side effects. It is possible that this lower starting dose may not be as effective as the~     higher FDA approved dose. If the patient does well with the lower dose for at least a month~     on treatment, the physician may consider increasing the dose to the FDA approved dose.~   "
78109|NCT02034994|"~     The main objective is to evaluate the effects of a multicomponent, school-based intervention~     combining change in nutritional behaviors with after school physical activity activities in~     reducing the excessive weight gain in schoolchildren.~   "
73234|NCT02098785|"~     Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest~     cause of death in the UK. Liver damage consists of two main components - a) damage to the~     cells of the liver, called hepatocytes, meaning the liver cannot function properly leading~     to jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of~     the liver, called Cirrhosis, leading to impaired function and inadequate blood flow through~     the liver with potential to develop into cancer. Manifestations of this state include~     ascites (fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver~     transplant is currently the only curative treatment for end stage chronic liver disease.~     Unfortunately its high demand has not been matched by an equivalent rise in liver donations~     and even when a transplant has occurred there are numerous lifestyle effects such as~     immunosuppression and kidney impairment thus outcome remains poor for many patients. Coffee~     has been shown to have mortality benefit in humans and drinking two to three cups a day was~     associated with a 40% reduced risk of developing cirrhosis, particularly alcohol related;~     and higher the more cups consumed. Previous work has demonstrated coffee reduces the level~     of fibrosis in the liver by interrupting signalling pathways, blocking the effects of~     special products, called cytokines, and reducing accumulation of iron. The investigators'~     hypothesis is that given the potential for caffeine to be used as a treatment in SSAO~     activity associated diseases it is important to see if the activity of SSAO can be blocked~     in healthy humans too. The Investigators' aim to examine the effect of caffeine on~     circulating VAP-1 levels in large numbers of healthy volunteers to assess its potential as~     an attractive therapeutic target in view of its low toxicity and widespread availability.~   "
73235|NCT02098772|"~     The objective of this investigation is to compare the cardioprotective effects and safety of~     two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in~     patients undergoing aortic valve surgery. The study design is a prospective, double blind,~     multicenter, randomized, Phase III comparison study intended to demonstrate superiority in~     surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24~     hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement~     (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively~     (e.g., myocardial infarction).~   "
73236|NCT02098759|"~     The primary objective of clinical part of EPISTOP project is to identify the clinical and~     molecular biomarkers of epileptogenesis in a prospective clinical study of patients with~     TSC.~      Secondary objective of the clinical part of EPISTOP is to compare the effects of standard~     antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs~     after electroencephalographic epileptiform discharges, in a randomized trial in TSC~     patients.~   "
73237|NCT02098746|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of~     pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients~     with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy~     (pioglitazone at 15 mg/day) in the routine clinical setting.~   "
73238|NCT02098733|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias~     Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical~     setting.~   "
73239|NCT02098720|"~     This study is designed to evaluate the effect of Conbercept therapy on visual acuity and~     anatomic outcomes and safety observed in subjects with very low vision secondary to wet~     age-related macular degeneration.~   "
73240|NCT02098707|"~     Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide~     significant improvements in postural instability in Parkinson's disease, whereas previous~     reports of physical interventions have suggested promising results. The investigators want~     to study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on~     balance disorders in Parkinson Disease (PD).~   "
73241|NCT02098694|"~     The purpose of this study is to determine whether patients with spondyloarthritis are more~     satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a~     difference between patients in a physiotherapy-led outpatient clinic and those in usual care~     regarding disease activity, function and mobility.~   "
73242|NCT02098681|"~     Context: Chest wall deformities in children are relatively common. One such deformity, known~     as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of~     these abnormalities - present in approximately 1 out of every 400-1000 births. This~     deformity is often a cosmetic problem for affected individuals. When severe, PE can also be~     associated with cardiopulmonary compromise.~      Treatment of PE involves surgical correction. There are several potential methods for~     correcting PE. In the past the most common repair involved an open procedure which involves~     excision and reshaping of the ribcage. More recently a minimally invasive procedure has been~     adopted involving the placement of a stainless steel or titanium bar underneath the sternum~     to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries~     with it significant post-operative pain management problems. In fact, the pain issues after~     Nuss procedure may be more significant than after open repair. The quality of postoperative~     pain control in these cases has been shown to affect several measurable objective outcomes~     during hospitalization including capacity for deep breathing, early mobilization,~     ambulation, and length of hospital stay.~      Epidural analgesia (EA) has been one of the standard methods for managing pain in the early~     postoperative period after PE repair. Unfortunately severe pain may persist after the~     removal of an epidural catheter resulting in a difficult transition period just prior to~     discharge from the hospital. In addition reports of neurological injury after epidural~     analgesia for Nuss procedures have appeared. In light of these issues, many institutions~     have opted for alternative methods of pain control including peripheral nerve blocks,~     patient controlled analgesia, and wound catheters.~      There remains significant debate as to which pain control methodology is best. There is~     little consistent data available on pain control or outcomes that occur after EA is stopped.~     Moreover there is reluctance in any one institution to trial or randomize patients to a~     variety of treatment modalities. For all of these reasons, investigators are proposing~     participation in a multi-institutional data sharing project concerning the repair of EA in~     which participating centers will collaborate to better understand the outcomes of~     perioperative care for patients undergoing correction of this problem.~   "
73243|NCT02098668|"~     Development of a bio-mathematical model of the human female cycle~   "
73244|NCT02098655|"~     Objective: To analyze different parameters in patients with Parkinson's Disease (PD)~     obtained through the use of a stabilometric platform and compare them with those of a~     control population. To interpret the data in order to find some postural instability~     indicators that can become useful to build a rehabilitation strategy for balance disorders~     in PD.~   "
73245|NCT02098642|"~     Parkinson's disease is a degenerative disorder of the central nervous system. The motor~     symptoms of Parkinson's disease result from the death of dopamine-generating cells in the~     substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early~     in the course of the disease, the most obvious symptoms are movement-related; these include~     shaking, rigidity, slowness of movement and difficulty with walking and gait. A~     multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different~     parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim~     to understand whether the passive mobilization of the metatarsophalangeal joint of the~     hallux determines an increase in the joint range in this district, allowing to improve, at~     least, the gait.~   "
73246|NCT02098629|"~     Heart attack is the leading cause of death in the developed world. Following heart attack,~     re-establishing blood flow in a clogged heart vessel using percutaneous coronary~     intervention (PCI) is the standard of care. This therapy is called reperfusion therapy.~     Unfortunately, reperfusion therapy itself poses additional heart muscle damaging effect, a~     process called reperfusion injury. Excessive reperfusion injury can offset the net benefit~     of heart vessel blood flow restoration in patients with heart attacks. For those heart~     attack survivors, massive reperfusion injury can contribute to heart failure which carries~     high risk for death and long-term disabilities. To date, there is no drug available that can~     reduce reperfusion injury in heart attack patients.~      Our group has demonstrated in a preclinical study that combining two available medications~     (milrinone and esmolol) when given right before the onset of reperfusion therapy greatly~     reduces heart muscle damage in an animal heart attack model. Furthermore, in a clinical~     safety, we demonstrated that combination therapy with milrinone and esmolol is safe in~     patients with heart attack undergoing PCI. If the heart-protective effect observed in our~     preclinical study can be replicated in human subjects, this proposed therapy will become the~     first of this kind to treat clinical reperfusion injury.~      The present trial is a proof-of-concept study to determine whether the combination~     administration of milrinone and esmolol at the onset of reperfusion reduces the heart muscle~     damage in heart attack patients who receive reperfusion therapy with PCI.~   "
73247|NCT02098616|"~     The purpose of this study is to determine whether treatment with~     Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is~     feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.~   "
73248|NCT02098603|"~     More than 530,000 individuals work as US Correctional Officers (COs) responsible for~     overseeing the approximately 1.6 million offenders who are incarcerated at any given time in~     the United States. Prison work is regarded as one of the most difficult occupations with~     CO's having one of the highest nonfatal injury rates of all U.S. occupations. The few~     studies done on CO's show high levels of stress, cardiovascular disease, high job burnout,~     increased sick leave rates and absenteeism, and decreased quality of life leading to~     premature illness/injury and high employer healthcare costs. Many of these conditions could~     be prevented by specific training activities and healthier lifestyles. The investigators~     wish to test a worksite-based, health promotion curriculum in COs with the overall~     hypothesis that the program will improve health and decrease injuries. The program proposed~     would be the first occupational intervention to improve the safety, and emotional and~     physical health of those who are charged with the complex task of prison work protecting the~     investigators communities. If successful, this proposal would result in an exportable,~     practical occupational safety and health program applicable for use by local, state, and~     federal correctional facilities.~   "
73249|NCT02098590|"~     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious~     diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity~     and mortality as well as a significant contribution to ongoing poverty in endemic countries.~     Ultimately, the key to malaria control, and hopefully eradication, would be an effective~     vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and~     clinical development, they have yet to achieve the level of efficacy necessary for effective~     malaria prevention. It has been shown previously that if healthy human volunteers taking~     chloroquine chemoprophylaxis are repeatedly exposed to Plasmodium parasites through the~     bites of infected mosquitoes, they are fully protected against a later challenge infection~     with a 'homologous' (genetically similar) Plasmodium parasite. This process is known as~     ChemoProphylaxis and Sporozoites, or CPS-immunization. One of the obstacles to developing an~     effective vaccine is the genetic heterogeneity of malaria parasites. To further consider the~     development of whole-parasite based vaccines against malaria and in order to better~     understand the protective immunity induced by CPS-immunization, it is essential to~     investigate whether heterologous protection against genetically diverse (heterologous) P.~     falciparum clones can be induced.~      This is a single center, randomized, double-blind study to determine whether healthy~     volunteers immunized with P. falciparum NF54 parasites under chloroquine prophylaxis are~     protected against a challenge infection with the genetically distinct NF135.C10 or NF166.C8~     P. falciparum clones.~   "
73250|NCT02098577|"~     The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian~     patients and compare this results with the results of a control group of patients treated~     with a stabilometric platform.~   "
73251|NCT02098564|"~     Background Patients with the same type of hand injury often reach different functional~     levels. Therefore, it is necessary to investigate what kind of rehabilitation is most~     efficient for each individual patient.~      Research has shown that a person's Sense of Coherence (SOC) affects how he /she deals with~     disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and~     should therefore; be taken into consideration when planning rehabilitation. It was concluded~     in a study that patients with a weak SOC who have had a hand injury, may benefit from extra~     support to manage their everyday activities in order to reach the same final outcome as~     patients with a strong SOC.~      Purpose To investigate two types of rehabilitation on patients with a hand-related injury~     (joint mobility exercises vs. activity-based training and joint mobility exercises) and to~     investigate whether SOC can be used as an indicator of which patients would benefit from~     activity-based training.~      Hypotheses~        1. Patients with a hand-related injury will benefit from activity-based training in their~          rehabilitation program.~        2. Patients with a weak SOC will achieve the best functional level, if activity-based~          training is included in their rehabilitation program.~        3. Patients with a strong SOC will not achieve a higher functional level, if~          activity-based training is included in their rehabilitation program.~      Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or~     older are included when referred to specialized outpatient occupational therapy after a~     hand-related injury. To ensure sufficient and balanced patient variation in relation to~     pre-rehabilitation sense of coherence, a balanced randomisation principle has been~     implemented.~      Data will be collected through questionnaires. The questionnaires measure SOC (13 items~     version), function (DASH), quality of life (EQ5D) and satisfaction.~      All participants will perform joint mobility exercises which are appropriate for their~     injury. In addition, participants who will be performing activity-based training will train~     with specific meaningful activities which they performed prior to the hand-related injury.~      Clinical relevance The knowledge obtained will be incorporated into the planning of~     occupational therapy rehabilitation services for this patient group, so that the patients~     will receive the most optimal conditions in which to achieve their previous level of~     function after a hand injury.~   "
73252|NCT02098551|"~     Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula~     verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E~     (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis~     patients.~   "
73254|NCT02098525|"~     Cryptococcal meningitis is one of the most common central nervous system infections among~     HIV-infected patients. The outcome is generally severe. This study aims to determine~     long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy~     (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic~     factors.~   "
73256|NCT02098499|"~     Haloperidol is known to be a safe alternative medication to control difficult pain, and has~     been shown effective when compared to placebo for controlling headaches. Investigators~     hypothesized that the combination of haloperidol and diphenhydramine would be a useful~     medication choice for migraine headache patients in the emergency department in comparison~     to a common migraine treatment regimen of metoclopramide and diphenhydramine.~   "
73257|NCT02098486|"~     Background and aims: The use of prophylactic antibiotics before endoscopic retrograde~     cholangiopancreatography (ERCP) is recommended by all major international~     gastroenterological societies, especially in the presence of an obstructed biliary system.~     Their use is intended to decrease or eliminate the incidence of complications following the~     procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there~     were a few reports concerning the dosage, duration and adopting antibiotics most suitable~     for this purpose. The aim of this prospective comparative study is to compare the occurrence~     rate of post-procedural complications, such as cholangitis, bacteremia and septicemia~     between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with~     bile duct obstruction who will undergo therapeutic ERCP procedure.~      Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample~     Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones,~     benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous~     moxifloxacin and ceftriaxone group, respectively (using simple randomization program).~     Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day,~     diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes~     before ERCP procedure, and will be given to a patient for more than 3 days if the patient~     develops symptoms and signs of cholangitis or septicemia.~   "
73258|NCT02098473|"~     The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment~     of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of~     double-blind treatment and 52 weeks of open-label extension.~   "
73259|NCT02098460|"~     To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on~     Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of~     the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the~     thickness of the Achilles tendon, the thickness of mean carotid intima-media, anti-oxidation~     biomarkers and serum lipid profile.~   "
73260|NCT02098447|"~     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous~     system stimulation on vital parameters of wound healing in diabetics. It is investigated if~     auricular vagal nerve stimulation has an effect on heart rate variability as well as~     peripheral local blood perfusion, and if this effect depends on the health status of the~     study participants (diseased/healthy).~   "
73261|NCT02098434|"~     The study is investigating the impact of progesterone and estrogen on brain areas that are~     involved with stress response and drug craving. The study will involve 40 women who will~     participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning~     procedures. Half of the women will complete the procedures during the luteal phase of the~     menstrual cycle; the other half will complete procedures during the follicular phase.~     Subjective and physiological measures (cortisol levels) will be used to measure stress and~     craving response. Hypothesis 1A is that all women will exhibit increased craving, stress~     response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST~     task. Hypothesis 1B is that these increased responses will be higher for women in the luteal~     phase than for women in the follicular phase of the menstrual cycle.~   "
73262|NCT02098421|"~     This study is considering current standard oxytocin dosing regimen in combination with Foley~     bulb for cervical ripening is associated with improved outcomes including greater percentage~     of women delivered within or less than 24 hours. The investigators will also assess other~     maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis),~     bleeding, uterine atony, cesarean delivery and use of regional analgesia.~      Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or~     no oxytocin while the Foley bulb is in place. As part of standard of care for inductions,~     Foley bulbs will be placed for all participants. Study participants who are randomly~     assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed.~     Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley~     bulb is removed.~      After delivery, information will be collected from participant's chart on the outcome of~     pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean~     section), and baby's outcome (such as birth weight, APGAR scores, and any complications).~   "
73263|NCT02098408|"~     Cognitive deficits are known to be a core feature of schizophrenia and seem to become~     manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive~     deficits are known to pose a critical barrier to functional recovery. Hence it is of vital~     importance to find intervention strategies that can alleviate these cognitive deficits and~     consequently improve daily functioning, and quality of life, as well as the prognosis for~     UHR-patients. The investigators will examine whether:~        -  Cognitive remediation therapy will be superior to standard treatment in improving~          cognitive functioning in UHR- patients (null hypothesis: No difference between the two~          groups).~        -  Cognitive remediation therapy will be superior to standard treatment in improving~          psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No~          difference between the two groups).~   "
73264|NCT02098395|"~     This trial is conducted in Africa, Europe and North America. The purpose of the trial is to~     investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1~     diabetes.~   "
73265|NCT02098382|"~     Non-interventional prospective data collection designed to evaluate clinical outcome on the~     efficacy of the use of Dilapan-S in the indication of labor pre-induction in women~     with/without a history of Caesarean section. The evaluation will be based on prospective~     data collection in at least four obstetrics centers in the Czech Republic.~   "
73297|NCT02097966|"~     The primary objective of this program is to provide Daclatasvir in combination with~     Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high~     risk of liver decompensation or death within 12 months if left untreated and who have no~     available therapeutic options.~   "
73266|NCT02098369|"~     About 1 million individuals in the US have a prescription for supplemental oxygen (O2).~     Using O2 can prolong life and increase quality of life. Patients often do not use their~     oxygen as prescribed, which means that they are not benefiting as much as they could be from~     this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for~     patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen~     prescription and improve health in patients with chronic obstructive pulmonary disease~     (COPD).~   "
73267|NCT02098356|"~     This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis~     bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base~     changes and overall control of metabolic acidosis with the 2 treatment regimens. These~     parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as~     part of usual care. They will then be switched to a lower bicarbonate prescription, after~     which these parameters will be reassessed. The study will also examine changes in~     inflammatory markers, glycemic control, ketogenesis, and lipolysis.~   "
73268|NCT02098343|"~     The purpose of this study is to make a preliminary assessment of the efficacy of a combined~     APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy~     regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian~     cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of~     the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD~     chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological~     activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400~     patients.~   "
73269|NCT02098330|"~     The purpose of this study was to compare the treatment effectiveness of steroid therapy for~     vestibular neuritis by using video head impulse test.~   "
73270|NCT02098317|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The~     pathogenesis of NAFLD is generally considered the result of a series of liver injuries,~     commonly referred as multi-hit hypothesis. Several studies suggest that inflammatory~     pathways and oxidative stress could be responsible of disease progression.~      The purpose of this interventional study is to evaluate the efficacy and tolerability of~     docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven~     nonalcoholic fatty liver disease (NAFLD).~   "
73271|NCT02098304|"~     This is a prospective, multi-centre, post-approval clinical study to assess the safety and~     the performance of the Calcivis Caries Activity Imaging System in aiding the identification~     of active caries lesions on the occlusal surfaces of human teeth. Following the~     identification of potential caries lesions by oral examination under ICDAS (International~     Caries Detection and Assessment System) guidelines, a disclosing solution will be applied~     which will cause areas of active demineralization (loss of calcium ions) to luminesce -~     these will be captured with an intra-oral camera to produce mapping images of the tooth~     surface. For the purposes of this study the presence / absence of luminescence will be used~     as an indicator of lesion activity / inactivity.~      The study will be deemed a success if the level of agreement between elevated luminescence~     with the Calcivis System, and areas of expected lesion activity as rated by the~     Investigators ICDAS staging, is above 70%, is not due to chance and correlates well with~     published data on active non-cavitated lesions in molars at various stages of eruption.~   "
73272|NCT02098291|"~     This study was designed to determine the effect of jaundice on the ability of G17DT to~     generate antibodies before and after treatment of biliary obstruction due to advanced~     pancreatic cancer.~   "
73273|NCT02098278|"~     The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with~     chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and~     chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride~     clearance.~      This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for~     12 weeks during the 13 week treatment period.~   "
73274|NCT02098265|"~     The purpose of this research is to determine if two non-invasive brain stimulation~     techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can~     increase the extent of stroke recovery.~   "
73275|NCT02098252|"~     The objectives of this study and registry are to offer the best management possible for~     patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of~     long-term outcomes, despite the presence of uncertainty. Management may include~     interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone~     or in combination) or conservative management.~      The trial has been designed to test a) whether medical management or interventional therapy~     will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an~     absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and,~     b) to test if endovascular treatment can improve the safety and efficacy of surgery or~     radiation therapy by at least 10% (80% to 90%).~      As for the nested trial on the role of embolization in the treatment of Brain AVMs by other~     means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the~     number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can~     be accomplished with an acceptable risk, defined as permanent disabling neurological~     complications of 8%.~   "
73276|NCT02098239|"~     The study was designed to assess the effect of jaundice on the ability of G17DT to generate~     antibodies before and after treatment of biliary obstruction due to advances pancreatic~     cancer.~   "
73277|NCT02098226|"~     The study objective is to confirm that the MBT-CA System identifies medically significant~     bacteria and yeasts from an isolated colony from any sample type processed by the clinical~     laboratory. For this purpose MBT-CA test results will be compared to bi-directional~     sequencing results.~   "
73278|NCT02098213|"~     Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of~     plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.~   "
73279|NCT02098200|"~     The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.~      It is a percutaneous catheter-based device designed for tricuspid valve repair in order to~     decrease effective cross-sectional area and relieve symptoms in patients with tricuspid~     valve regurgitation.~   "
73283|NCT02098148|"~     The primary purpose of this study is to investigate whether administration of xenon reduces~     symptoms of Obsessive-Compulsive Disorder (OCD). Xenon is a naturally occurring gas that has~     been used in clinical settings both as a general anesthetic agent and as a contrast agent~     for computed tomography (CT) scans. Investigators believe that xenon may be effective in~     reducing symptoms of OCD due to its ability to reduce the activity of a specific brain~     chemical called glutamate, which has been shown to be abnormal in the brains of people with~     OCD.~      It is important to understand that this study uses a placebo, or inactive, treatment. In~     this study, the placebo treatment is inhalation of room air (instead of xenon). All~     participants will receive both xenon and placebo treatments at some point over the course of~     the study. However, neither the participants nor the study investigators will know which~     treatment you are receiving.~   "
73284|NCT02098135|"~     stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality,~     interia sensor,~        -  Trial with medical device~   "
73285|NCT02098122|"~     Functional recovery following SCI in adults is limited. Improvements in the quality of life~     of affected persons are associated with the recovery of functions that allow independent~     living, for example use of the arms and hands. Rehabilitative training has been shown to aid~     upper limb recovery. However, there are likely vast differences in the amount of time~     individuals spend actively training (during rehabilitation sessions in the clinic) and what~     they do in their non-training time (during daily life). The activity, or lack of, during the~     non-training period could interfere (positively or negatively), with the specific training~     in the rehabilitation session. However, there is little information available about this.~      Inertial measurement units are increasingly being used in human movement and rehabilitation~     research. The use of such technology is a promising approach to rapidly and discreetly~     collect objective movement information. The investigators plan to introduce a novel,~     long-term, activity sensor into clinical SCI rehabilitation. The investigators use this~     sensor to precisely measure movement of the upper limb over extended periods of time. Upper~     limb activity recordings from these sensors allow us to detail the amount and duration of~     activity during specific periods of upper limb rehabilitation and recovery.~      The investigators aim is to measure upper limb activity. The investigators aim to track~     changes in the activity of the upper limb during recovery and rehabilitation in patients~     with cervical SCI as well as collect reference values of upper limb activity in chronic~     sufferers. The recordings from this activity sensor will provide a more detailed~     understanding of how everyday upper limb activity contributes to functional recovery.~   "
73286|NCT02098109|"~     This study will compare the results of stem cell mobilization using drugs called filgrastim~     (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02~     filgrastim (Granix) and plerixafor.~   "
73287|NCT02098096|"~     The purpose of this study is to develop a negative work exercise regimen as an intervention~     for posttraumatic osteoarthritis (PTOA). Negative work is the force produced by muscles as~     they lengthen, and regularly occurs with common activities such as lowering an object from a~     shelf or walking down stairs. In this study, the investigators are examining the~     effectiveness of negative work exercise over a 12-week period in older, male, Veterans.~   "
73288|NCT02098083|"~     Data collection for this study will be done by clinicians working in inpatient~     rehabilitation units with persons with acute stroke. No interventions are included in this~     study. It is designed to capture trends in current clinical practice for persons with~     stroke. This data will be useful in identifying the most beneficial and effective walking~     treatments as well as most significant patient characteristics that impact recovery for~     persons acutely after stroke. All data collection will take place during the inpatient~     rehabilitation stay.~   "
73289|NCT02098070|"~     The focus of the study is to determine the prevalence and variance of self-reported knee~     pain characteristics in a community-derived sample of adults aged 40 years and over. It will~     also identify characteristics such as structural changes of osteoarthritis of the knee as~     well as physiological parameters and blood and urine biomarkers.~   "
73290|NCT02098057|"~     The overall hypothesis of this research study is that gluten intake alters intestinal~     barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit~     non-celiac gluten sensitivity (NCGS).~   "
73291|NCT02098044|"~     The OA and Football Study is an epidemiological study designed to establish the prevalence~     of knee osteoarthritis in retired professional footballers. The study will also identify the~     key risk factors associated with knee osteoarthritis. The study is comprised of three~     phases: Phase I involves the dissemination of a questionnaire (demographic details, players~     history, injury and surgery and other known risk factors of OA), Phase II is a radiographic~     study that involves x-rays in a sample of footballers both with and without knee pain and~     Phase III is a case control study which will compared retired professional footballers with~     age-matched controls recruited from the general population in the East Midlands region.~   "
73292|NCT02098031|"~     Undernutrition and growth restriction due to poor diet and inadequate nutrient intake~     continues to be a global challenge, particularly in the developing countries including~     Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of~     resources or knowledge or a combination of both. Poor nutrient intake and impaired growth~     may affect brain and cognitive development.~      This study aims to evaluate nutrient intake, growth and cognitive function among children~     between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western~     Uganda. The investigators hypothesize that nutrition education to mothers can bring about~     improved dietary intake and nutritional status among children aged 6-36 months.~   "
73293|NCT02098018|"~     There are many ways to reduce stress. This study will compare 2 different programs for~     reducing stress. In addition to looking at how well the programs reduce stress, we will also~     ask questions about how these programs may be working.~   "
73294|NCT02098005|"~     Chronic spinal pain (CSP) includes chronic low back pain, failed back surgery, chronic~     whiplash associated disorders, chronic non-traumatic neck pain, etc. The current~     investigators and others have provided evidence for impaired motor control of spinal muscles~     in patients with CSP. In addition, there is increasing evidence that central mechanisms,~     i.e. hyperexcitability of the central nervous system and brain abnormalities (e.g. decreased~     brain matter density) play a role in CSP. Hence, treatments for CSP should not only address~     the spinal muscles and joints, but also the brain. Therefore, a modern neuroscience~     approach, comprising of pain neuroscience education followed by cognition-targeted motor~     control training, can be applied.~      The scientific objective entails examining the effectiveness of the modern neuroscience~     approach vs. usual care evidence-based physiotherapy for reducing pain and improving~     functioning in Flemish patients with CSP. A secondary objective entails examining the~     effectiveness of the modern neuroscience approach vs. usual care evidence-based~     physiotherapy for altering brain's structure and function (magnetic Resonance Imaging) in~     Flemish patients with CSP. Therefore, a multi-center triple-blind randomized controlled~     trial will be conducted.~      To comply with this scientific objective, 120 CSP patients will be recruited and subjected~     to the baseline assessment. The baseline assessment includes the assessment of pain~     (including symptoms of central sensitization and conditioned pain modulation), the~     assessment of restrictions in functioning, brain imaging, the evaluation of motor control~     and muscle properties, spinal mobility, and psychosocial correlates. Baseline analysis will~     provide descriptive statistics and will lead to calculate correlation between the different~     outcome measures and predictors of pain and dysfunctioning. In a next step, included~     patients will be randomized to the experimental or control group. Those in the experimental~     group will receive neuroscience education combined with cognition-targeted motor control~     training. Those in the control group will be subjected to a control intervention, including~     back/neck school and general exercises. After the neuroscience education has been given, the~     experimental subjects will fill in the neurophysiology of pain test. Several follow-up~     assessments will take place. Part of the assessment (functionality (PDI questionnaire) and~     psychosocial correlates (Pain Catastrophizing Scale (PCS), pain vigilance and awareness~     questionnaire (PVAQ), Tampa Scale for Kinesiophobia (TSK), Illness Perception Questionnaire~     revised (IPQ-R)) will be re-evaluated after the first 3 sessions. The complete 'baseline'~     assessment will be repeated in the month following the treatment complement, rounding up the~     short-term follow-up assessment. Six months after the baseline assessment, pain, functioning~     and psychological correlates are assessed in an intermediate online assessment. One year~     after baseline assessment the complete assessment is repeated for the last time, unless the~     intermediate assessment indicates that treatment effects are no longer present. Both short~     and long term treatment effects can be studied and predictors for therapy success can be~     unraveled. Also correlations between changes in different outcome measures can provide~     relevant and innovative information.~      The proof of principal suggests a strong effect reported by large effect sizes for pain and~     disability compared to usual care.~   "
73295|NCT02097992|"~     The primary objective of the proposed study is to test the hypothesis that in patients with~     stable COPD who use ICS regularly, a single dose of and long-term treatment of 4 weeks with~     roflumilast increase albuterol -induced vasodilation (delta Qaw). These vascular effects of~     roflumilast can be considered to be anti-inflammatory.~   "
73296|NCT02097979|"~     OBJECTIVE Our objective was to determine whether two group educational sessions plus~     one-on-one eye drop instillation training would improve adherence to glaucoma therapy as~     measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was~     that adherence would be improved in the intervention group and that patients would better~     understand their disease and how to manage it.~      METHODS Study Design and Population: A randomized controlled clinical trial was conducted in~     newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half~     of the participants were randomized to receive the intervention and half were randomized to~     receive a delayed intervention at the conclusion of the study. Inclusion criteria included a~     diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and~     prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the~     Quebec Health Insurance Program) throughout the course of the study. There were three~     sources of data for this study: a questionnaire, the medical record, and RAMQ prescription~     drug claims data. Follow-up was for one year.~      Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached~     eligible patients to determine their interest in participating in the study. Interested~     participants signed the informed consent form and were randomized. Participants in the~     intervention group were given an appointment to come back to the Hospital for the group~     intervention. Participants in the control group were given an appointment to receive the~     group intervention at the end of the study.~      Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational~     sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each~     patient received one-on-one teaching on how to properly instill drops without touching the~     eye or using unnecessary drops.~      Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the~     end of the study to all participants. The intervention group completed the questionnaire~     after the intervention while the control group completed the questionnaire before the~     intervention. Questions were included on demographics, systemic comorbidities, ocular~     medications, eye drop practices and difficulties, and glaucoma knowledge.~      The instructor rated the ability of the participant to put eye drops in the eye taking into~     account the number of drops that were used and whether contact with the lid or conjunctiva~     occurred (good, fair, bad).~      We created a composite score on the perception of the importance of glaucoma eye drop~     therapy using the following four questions: 1) do you think glaucoma is a serious disease,~     2) do you believe that your treatment will be effective, 3) do you think your drops can~     lower the pressure in your eyes, 4) do you think your drops can help to preserve vision.~     Answers of no or do not know were given 0 points and answers of yes were given 1 point.~     Scores were summed and the composite score ranged from 0 to 4.~      Medical Chart Review: At the end of the follow-up period, information was obtained on: the~     prescribed eye drop therapy for each patient per eye, whether the patient had undergone~     glaucoma filtering surgery, whether the patient had died or was no longer being followed,~     the most recent visual field mean deviation in the better eye using the Humphrey Visual~     Field Analyzer 24-2 SITA Standard Program.~      Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication~     Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by~     the number of days in which a prescription was required. Each person gave consent to contact~     the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected~     on the date of purchase, and the name, dose, and class of the medicine. Data on the number~     of days of medication available per bottle were taken from the Rylander and Friedman studies~     with the minimum value used. For the numerator of the MPR, we calculated how many days of~     medication were available using RAMQ data. For the denominator of the MPR, we calculated the~     number of days that medication was prescribed in the medical chart. We took into account~     whether drops were needed for one or two eyes. If a participant was on multiple medications,~     we calculated a single mean MPR for all medications. We then dichotomized the MPR so that~     those having medication less than 75% of the days were defined as non-adherent, as we did~     previously in Djafari et al.~      SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily~     eye drops despite not noticing any benefit to their vision and despite frequent side~     effects. Low cost interventions that help to improve adherence are needed.~   "
73298|NCT02097953|"~     The purpose of this study is to understand how an antibiotic, rifampin, may change the blood~     levels of another antibiotic, daptomycin, in the body. In addition, the effect of~     polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the~     body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin~     will decrease the blood levels of daptomycin and that the effect will be greater for certain~     P-glycoprotein polymorphisms.~   "
73299|NCT02097940|"~     This study presents the hypothesis that the sensory processing engine improves balance and~     agility for football athletes.~   "
73300|NCT02097927|"~     The study will be a 3-way crossover design: it will assess the impact of consuming a~     beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on~     energy intake compared with a low energy version with the same sensory characteristics, and~     a non-sensory enhanced high energy control.~      In addition, saliva samples will be collected at regular intervals for the identification of~     novel biomarkers of energy intake.~   "
73301|NCT02097914|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S over the past two decades has left smoker's~     homes as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has~     considerable potential to reduce smoke exposure, but suitable channels to reach low-income~     families are limited.~      The proposed research will systematically test an intervention designed to create smoke-free~     homes in low income households among 2-1-1 callers. During this randomized control trial,~     researchers will disseminate and evaluate a brief smoke-free homes intervention through the~     established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated~     3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory~     assistance, that links callers to community-based health and social services. The main~     hypothesis to be tested is that a higher proportion of households in the intervention group~     will establish and maintain a smoke-free home than in the measures-only control group.~   "
73302|NCT02097901|"~     The hypothesis is that microfractures in the footprint of the humerus will aid to improve~     the tendon healing to the bone. The aim of the study is to investigate whether the use of~     microfractures at the footprint of the rotator cuff will improve the tendon healing when~     reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to~     repair with or without microfracture.~   "
73303|NCT02097888|"~     This will be a prospective observational study. The investigators will compare~     Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging~     and bone metabolism in healthy volunteers living at different altitudes.~   "
73304|NCT02097875|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and~     reduced patient survival. In addition, in some sites, such as the brain, it is critical to~     avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on~     function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to~     visualize the edges of the tumor and small groups of cancer cells that have spread to other~     sites in real-time, as they operate.~   "
73305|NCT02097862|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed degenerative disc disease.~   "
73306|NCT02097849|"~     Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria~     toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who~     have been treated with Tecfidera (BG00012) versus those treated with non pegylated~     interferon (IFN).~      Secondary objective is to evaluate the immune response to vaccination with 23-valent~     pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]~     and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T~     cell-dependent neoantigen response].~   "
73307|NCT02097836|"~     If a child with cerebral palsy does not develop independent sitting balance by 4 years of~     age, their prognosis for walking is very poor. Surprisingly little is known about how to~     facilitate head control or upright sitting balance and functional mobility in the child who~     is not developing these skills. This is one of the first studies that will examine~     intermediate stages in the development of the postural control system in children with~     neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have~     developed a method called Targeted Training in which trunk control is trained in children~     segment by segment using a specific training device. This study aims to examine kinematic~     and electromyographic changes in a case series of children who undergo a 6-month Targeted~     Training intervention.~   "
73308|NCT02097823|"~     The purpose of this study is to determine the feasibility of a larger trial comparing~     olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two~     medications to treat nausea and vomiting in children receiving chemotherapy. Children~     receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will~     receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized~     to see which medicine they receive first. The investigators will record the number of extra~     medications used for nausea, the number of times a child vomits, and the amount of nausea~     the child feels each day.~   "
73309|NCT02097810|"~     Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded~     by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1~     (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or~     more of these targets are present in several different tumor types, including non-small cell~     lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer,~     pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer~     with a detectable molecular alteration in targets of interest may be eligible for~     enrollment.~      Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation~     scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in~     the dose expansion portion of the study.~   "
73311|NCT02097784|"~     This prospective study focuses on the interest of the echocardiography for cirrhotic~     patients, who present acute kidney injury corresponding to the criteria of hepatorenal~     syndrome. This echocardiography will be done before the volemic expansion and the final~     diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe~     the hemodynamic characteristics of this population at the time of acute kidney injury and~     their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients~     with elevated filling pressure, predicting poor outcome of volemic expansion will be~     excluded of the study after the echocardiography and will not undergo volemic expansion but~     appropriate management.~   "
73312|NCT02097771|"~     Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks~     airways: LMA SupremeTM vs Ambu AuraOnceTM~   "
73313|NCT02097758|"~     Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is~     useful for evaluation of defect size and shape. The investigators suggested optimal device~     size using three-dimensional transesophageal echocardiographic image and our formula in~     previous study.~      Purpose: In this study, the investigators seek to predict the correct device size and~     confirm the accuracy of the formula that we made before device closure in ASD patients.~   "
73314|NCT02097745|"~     This study will assess the long-term safety and efficacy of repeating treatment with~     MabThera, in combination with methotrexate and steroids, in patients who were previously~     randomized into MabThera study WA17042. The anticipated time on study treatment is until~     Mabthera is available on the local market and the target sample size is 100-500 individuals.~   "
73315|NCT02097732|"~     This is a study to test the efficacy of using standard immune therapy for melanoma prior to~     stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery~     followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good~     as or better than controlling brain metastases as compared to stereotactic radiosurgery~     followed by immune therapy.~   "
73316|NCT02097719|"~     This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared~     to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel~     forming solution) in patients who require IOP lowering therapy.~   "
73317|NCT02097706|"~     Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders~     with high morbidity and mortality. It affects the lives of millions worldwide and is often~     highly incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all~     patients have experienced suicidal ideation and about 10% actually commit suicide, a rate~     almost 50 times higher than in the general population. Mostly young women are at greater~     risk for the disorder and are three times more likely to be diagnosed with BPD than men.~      BPD aetiology is complex and could be explained by both biological and environmental~     factors. Among the environmental factors, sexual or physical abuse, parental divorce, loss~     or illnesses are identified as the most common ones. These factors can induce dysfunctional~     behaviours, which might cause emotional dysregulation, high impulsivity and frequent self-~     injurious behaviour.~      However, there are no pharmacologic interventions that are known to be specifically~     effective to treat BPD. Therapeutic options for this devastating disorder is still far from~     adequate for treating acute illness episodes, relapses, and recurrences and in restoring~     premorbid functioning. In addition, some patients are unable to tolerate existing therapies~     for BPD, which leads to either frequent changes in medications or to non-adherence.~     Therefore there is an urgent need for the development of more rapidly effective treatments~     for BPD.~      A growing body of evidence suggests that glutamatergic neurotransmission, in particular~     N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple~     psychiatric disorders. This has led to various clinical trials with glutamate modulating~     drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's~     disease is increasingly being studied in a variety of non-dementia psychiatric disorders.~     Results from these studies have proved that the trial drug was safe and well tolerated and~     has the potential for use in the treatment of psychiatric disorders.~      To date, there are no published data on the use of trial drug in the treatment for BPD.~     Therefore, the investigators intend to study the efficacy of this novel drug as an addition~     to ongoing therapy with atypical antipsychotics in patients with Borderline Personality~     Disorder. This study will recruit 30 BPD patients. The patients will be randomly allocated~     to receive either the study medication (20mg/ day) or placebo via oral administration for~     eight weeks. To observe the efficacy of the trial treatment, all participants will be~     assessed at various time intervals for different borderline and cognitive symptoms.~   "
73318|NCT02097693|"~     There are limited therapeutical options for patients with secondary dystonia due to cerebral~     palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep~     brain stimulation (DBS) has proven to be a safe and effective therapy for patients with~     parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with~     dyskinetic cerebral palsy are limited with heterogeneous data.~      With STIM-CP we investigate the effect of DBS on quality of life in young patients with a~     dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain~     injury. Additionally, the effect of DBS on motor development, speech, memory, attention,~     cognition and pain perception will be assessed. In total, 20 patients aged 7-18 years~     diagnosed with dyskinetic cerebral palsy, who will receive DBS, should be included. 11~     German DBS-centres will participate in the trial.~      We assume that DBS reduces the severity of dystonia and improves the quality of life in~     these patients.~   "
73319|NCT02097680|"~     It seems plausible that increased aromatase activity in obese men, as a result of a larger~     fat mass, is responsible for decreased levels of testosterone. Therefore aromatase~     inhibition increases testosterone levels, which may affect hepatic and cardiac function.~      In this intervention study two groups of hypogonadal obese men are compared. Group A is~     treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months;~     a group with normal testosterone and low oestrogen concentrations. Group B is treated with~     placebo once every two days during four months; this group will retain low testosterone -~     and high oestrogenic concentrations.~      The primary objective of the study is to evaluate effects of changed sex steroids in obese~     men on hepatic and cardiac function.~   "
73333|NCT02097498|"~     The overall objective of the present proposal is to assess whether medical simulation can~     enhance the safety and proficiency profile of paramedics performing prehospital endotracheal~     intubation, and whether feedback from an airway management expert observing the simulation~     enhances skill retention after 12 and 24 months. Since no validated proficiency assessment~     tool currently exists to measure the skill of paramedics in airway management, one will be~     developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo~     simulation training similar to that required for certification. A baseline assessment of~     proficiency will be obtained. One group will be randomized to receive simulation training~     similar to that required for certification, while the other group will receive feedback from~     an airway management expert linked to the simulation test site via a 2-way audio-video feed.~     Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill~     level was maintained or whether skills deteriorated, and whether expert intervention had any~     impact on skill retention.~   "
73320|NCT02097667|"~     Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses~     worldwide each year and contributing to 50% of stillbirths. Severe early onset FGR affects 1~     in 500 pregnancies, leading to stillbirth or the need for delivery before 28 weeks~     gestation. The combination of FGR and prematurity is associated with a significant risk of~     neonatal mortality and short and long-term complications. Even modest increases in~     birthweight (e.g from 500 to 600g) and gestation at delivery (e.g from 26 to 27 weeks) are~     associated with significantly better outcomes but there are currently no treatments.~      The EVERREST Clinical Trial, funded by the European Commission, aims to develop a treatment~     which will increase fetal growth in severe early onset FGR. It will use gene therapy~     injected into the uterine arteries of the mother to increase the levels of vascular~     endothelial growth factor (VEGF) and so increase uterine artery blood flow and fetal growth.~      The EVERREST prospective study aims to form a clinical database and biobank of pregnancies~     affected by severe early onset FGR to improve understanding of the condition and serve as a~     comparison to assess the safety and efficacy of this intervention.~      The prospective study will take place across four European centers who will later take part~     in the EVERREST Clinical Trial. Women with singleton fetuses with early onset FGR will be~     approached to take part in the study. Participating women will provide blood samples,~     details of their clinical condition, samples of umbilical cord blood, placenta and~     myometrial and placental bed biopsies at the time of Caesarean section (if needed). Data on~     short and long-term outcomes of the babies will be collected. All data will be entered onto~     a central database for eventual use as a comparator for treated women on the EVERREST~     Clinical Trial, for which separate ethical approval will be sought.~   "
73321|NCT02097654|"~     Primary Objective: To quantify the benefits of the SENATOR decision support software on the~     reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the~     effect of SENATOR with regard to use of appropriate non‐pharmacological therapies in~     subjects with one core geriatric syndrome.~      Tertiary Objectives: to examine the association of SENATOR use with subject survival,~     morbidity and health related quality of life.~      Health Economic Objective: To examine the potential health economic consequences of using~     SENATOR.~      There are two study periods:~      Period I: Prospective multinational, multicentre observational study to estimate the~     baseline adjudicated medical and surgical ADR rates by clinical sub speciality in 6~     international sites.~      Period II: Prospective multinational, multicentre, cluster randomized, two parallel arm,~     open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR~     software in reducing ADRs in older hospitalized subjects.~   "
73322|NCT02097641|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to~     assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human~     Mesenchymal Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS).~     This study is the extension of the Phase 1 pilot study (NCT01775774). Patients will be~     randomized to receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation.~     Patients will be followed daily for adverse events through day 28, death or hospital~     discharge, whichever occurs first. Vital status will be collected at 6 and 12 months after~     study enrollment.~   "
73323|NCT02097628|"~     The purpose of this study is to compare volume- and pressure- controlled ventilation with~     laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery~     in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and~     complications.~   "
73324|NCT02097615|"~     At present research has generated controversy regarding the utility of antiseptics in wound~     management for diabetic foot ulcers syndrome. However, these studies have been done in~     tissues and animal models. This study involves the best presently antiseptic for residual~     effect and low toxicity in an approach to eliminate microorganisms promoters formation of~     biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers~     syndrome .~      So it is necessary to determine if irrigation ulcer diabetic foot syndrome with~     chlorhexidine 0.125 % aqueous solution determines the decrease of the surface to a greater~     extent than the standard treatment using irrigation with sterile deionized water .~   "
73325|NCT02097602|"~     This is an observational study designed to monitor the course of the fraction of reticulated~     platelets and the correlation thereof to major adverse cardiac and cerebrovascular events~     after noncardiac surgery.~   "
73326|NCT02097589|"~     The purpose of this research study is to: Improve the effectiveness of vaccinations by~     identifying the effect of cholesterol medication, statins, on immune responses.~   "
73327|NCT02097576|"~     The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka~     honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan~     findings compared to nasal saline rinse without manuka honey in patients with chronic~     rhinosinusitis.~      Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New~     Zealand. It has been shown to have antibacterial activity against common bacteria that cause~     chronic sinusitis.~   "
73328|NCT02097563|"~     The present study aims to :~        1. compare different approaches (high intensity vs. low intensity) to training community~          providers (those who routinely treat young patients with bipolar disorder, psychosis,~          or sub-threshold high-risk conditions) on the implementation of family-focused~          treatment (FFT);~        2. assess the cost of FFT training and implementation support; and~        3. determine whether these different forms of clinician training are associated with~          different outcomes over 1 year among patients with early-onset mood and psychotic~          disorders.~   "
73329|NCT02097550|"~     This project seeks to improve the health of patients with chronic kidney disease (CKD) by~     developing and testing an electronic health intervention (that will combine secure e--mail,~     smartphone text message, and online video materials) to promote patient use of effective~     medications. The information we collect on the electronic health intervention will guide~     future research, including a larger trial and other studies among related patient groups~     (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the~     potential to improve health outcomes for the millions of patients with CKD who are not yet~     receiving effective medications.~   "
73330|NCT02097537|"~     The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation~     challenge in children with bronchial asthma.~   "
73331|NCT02097524|"~     The main purposes of this study are to describe the pharmacodynamic effects, safety and~     pharmacokinetics of a single dose of sarilumab.~   "
73332|NCT02097511|"~     This is a randomized, open-label, single & multiple-dose, three-sequence, three-period~     crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition~     of metoprolol tartrate in healthy male volunteers~   "
73334|NCT02097485|"~     The purpose of the study is to evaluate ovicidal efficacy of a single application of~     abametapir lotion 0.74% w/w intended for the treatment of head lice.~   "
73335|NCT02097472|"~     The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered~     intramuscularly to healthy Kenyan adults and toddlers who have been primed with a~     pneumococcal conjugate vaccine (PCV).~      Additionally, the study will explore whether a measurable immune response is elicited when~     PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with~     PCV.~   "
73336|NCT02097459|"~     It suggests in the Guideline that the postmenopausal women with breast cancer who have taken~     selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from~     changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized~     and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to~     AIs in perimenopausal and recently postmenopausal women with early-stage hormone~     receptor-positive breast cancer.~   "
73337|NCT02097446|"~     -  Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous~          cystadenoma)~        -  Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)~        -  Primary Outcome Measure : Anti-adhesion Rate~        -  Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative~          Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)~   "
73338|NCT02097433|"~     As part of the global clinical development program for Dacomitinib, studies are planned in~     cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects,~     as required by the Chinese Health Authorities, is therefore warranted.~      The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.~   "
73339|NCT02097420|"~     The purpose of the study is to provide evidence of safety and effectiveness of the study~     valve. The rationale is to offer a replacement mitral valve for patients with anatomy that~     is too small for the currently commercially available valves ranging in size from 16mm to~     37mm.~   "
73340|NCT02097407|"~     Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this~     prospective randomised study, we determined whether preoperative dexmedetomidine~     administration could reduce the half maximal effective concentration (EC50) of propofol for~     successful i-gelTM insertion without muscle relaxants.~   "
73341|NCT02097394|"~     The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora~     drugs(Bifidobacteria) can decease recurrence rate of colon polyps~   "
73342|NCT02097381|"~     HIV infection is associated with a state of chronic, generalized immune activation that has~     been shown in many studies to be a key predictor of progression to AIDS. The molecular,~     cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation~     are complex and still poorly studied. There is, however, growing consensus that both viral~     and host factors contribute to this phenotype, with emphasis on the role played by the~     mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known~     that in HIV-infected individuals, a severe depletion of intestinal cluster of~     differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial~     translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell~     reconstitution under combined antiretroviral therapy (cART) remains poorly understood.~      This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1~     and Th17, in blood and colon samples collected from HIV-infected individuals before and~     after a short term cART.~   "
73343|NCT02097368|"~     The main objective is prospectively study the upper airways function in an adult population~     of neuromuscular patients. The main measurement will be the evolution of tongue strength~     recorded each year during annual clinical evaluation on a 5 years period.~   "
73344|NCT02097355|"~     TriVox Health is an online system designed to make it easy for healthcare providers to~     monitor patients' disease symptoms and functioning over time and in between in-person visits~     (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and~     randomized clinical trial methods, we will evaluate the impact of TriVox on the health~     outcomes, patient/family experience of care, and healthcare utilization for children and~     adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism,~     depression, and epilepsy.~   "
73345|NCT02097342|"~     This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients~     with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function~     will be studied.~   "
73346|NCT02097329|"~     To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist~     and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.~   "
73347|NCT02097316|"~     The study will be conducted, in cross-over with a time interval of at least 2 days between 2~     treatment periods. Patients will be randomized into 2 groups According to the order of the~     randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days~     of treatment with their usual pumps.~   "
73348|NCT02097303|"~     This is an open label study designed to examine the effects on concurrent administration of~     Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with~     symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre-~     and post- chemotherapy setting. Both medications are approved by the US Food and Drug~     Administration for this indication.~   "
73349|NCT02097290|"~     This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left~     Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy~     Defibrillator (CRT-D) devices.~   "
73350|NCT02097277|"~     The purpose of this study is to assess the potential of BMS-986036 for treatment obese~     adults with type-2 diabetes.~   "
73351|NCT02097264|"~     This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of~     action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with~     rheumatoid arthritis (RA) and an inadequate response to Methotrexate.~   "
73352|NCT02097251|"~     Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type~     7 with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV~     administration every other week (QOW) for up to 144 weeks.~   "
73353|NCT02097238|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     osteosarcoma that has come back after treatment (recurrent) or has not responded to~     treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow~     the growth of tumor cells by disrupting the cell cycle.~   "
73354|NCT02097225|"~     This phase I trial studies the side effects and best dose of heat shock protein (Hsp)90~     inhibitor AT13387 when given together with dabrafenib and trametinib in treating patients~     with melanoma or solid tumors that have spread to another place in the body (metastatic) or~     cannot be removed by surgery and have come back after previous treatment (recurrent). Hsp90~     inhibitor AT13387, dabrafenib, and trametinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
73355|NCT02097212|"~     The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC.~     Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms~     (daytime and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular~     abnormalities of the chest wall and the diaphragm), and effect of interventions (CPAP and~     BIPAP) in these diseases.~   "
73356|NCT02097199|"~     This study investigates the influence of an increased physical activity and sports workload~     in formerly nonsporting healthy individuals on current promising biomarkers of~     atherosclerosis research.~   "
73357|NCT02097186|"~     Major vascular surgery involves operations to repair swollen blood vessels, clear debris~     from blocked arteries or bypass blocked blood vessels. Patients with these problems are a~     high-risk surgical group as they have generalized blood vessel disease. These puts them at~     risk of major complications around the time of surgery such as heart attacks , strokes and~     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in~     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple~     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote~     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply~     to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a~     further five minutes. This cycle is repeated three more times. The blood supply is~     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated~     brief interruption of the muscular blood supply sends signals to critical organs such as the~     brain and heart, which are rendered temporarily resistant to damage from reduced blood~     supply. Several small randomized clinical trials in patients undergoing different types of~     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial~     aims to determine whether RIPC can reduce complications in routine practice.~   "
73358|NCT02097173|"~     This study is conducted to assess the relative bioavailability of MTX administered~     subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection~     (25mg/mL).~   "
73359|NCT02097160|"~     The study is a parallel interventional randomized dose-response trial designed to improve~     vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects~     will be recruited from the general population in the greater Montreal area. The study will~     be conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University.~     Children will be required to attend two study visits. Some information will be collected~     through monthly telephone survey to the parents. The investigators will add vitamin D to~     cheese and yogurt for daily consumption at home over a three month period. All products will~     be provided to the parents in the form of coded containers that do not contain any labels~     aside from the group and expiration date. Ingredient lists will be provided upon consenting~     to the study. To better understand vitamin D status; dietary intake, hematology, serum~     biochemistry including 25(OH)D, growth, and body composition will be measured at the~     beginning and end of the three month study period. In addition, bone mass at baseline will~     be assessed. Sun exposure will be documented and a skin pigmentation test will be used to~     more objectively assess chronic sun exposure. The investigators will also investigate the~     association between vitamin D intake and status with immune function.~   "
73360|NCT02097147|"~     To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually~     active healthy adults.~   "
73361|NCT02097134|"~     This pilot clinical trial studies whether unilateral group D retinoblastoma, or~     retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye,~     can be treated with a new technique for delivering chemotherapy directly into the blood~     vessel that supplies the affected eye. This new technique is called intra-arterial~     injection. This may give children with unilateral retinoblastoma a lower chance of needing~     surgery to remove the eye and reduce the amount of treatment side effects.~   "
73362|NCT02097121|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the~     treatment of urinary incontinence due to overactive bladder in pediatric patients between~     the ages of 12 to 17 years who have not been adequately managed with anticholinergics.~   "
73363|NCT02097108|"~     This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to~     evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen~     after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.~      This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV~     infected women from a PI based regimen to raltegravir.~   "
73364|NCT02097095|"~     This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which~     biological samples will be collected for future investigations on biological correlates,~     markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, A~     phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy,~     safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342~     (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic~     region, (see NCT 01755598) will be asked to participate in this sub-study. Subjects~     enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018~     protocol but will have additional blood samples collected for the sub-study.~   "
73365|NCT02097082|"~     An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold~     (DRS) system for the treatment of patients with obstructive superficial femoral artery~     disease.~   "
73399|NCT02096627|"~     In this project, the investigators aim to compare the safety, efficacy, and predictability~     outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an~     effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may~     lead to preservation of endothelial cells compared to conventional CE IOL.~   "
73400|NCT02096614|"~     Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene~     transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid~     tumors.~   "
73366|NCT02097069|"~     The investigators aim to compare the effect of different inositol stereoisomers~     supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant~     women with GDM and in preventing adverse obstetric outcomes.~      The study population includes 80 women with GDM, randomly allocated to subgroup A (folic~     acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C~     (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol~     550mg/13,8 mg twice a day).~      Folic acid or inositol stereoisomers will be administered starting at the enrolling time~     (24-28 week gestation, after GDM diagnosis) till the delivery.~      The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index~     (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28~     weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin~     therapy and insulin dosage will be registered.~   "
73367|NCT02097056|"~     This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating~     safety and efficacy of donepezil hydrochloride in patients with moderate to severe~     Alzheimer's disease.~   "
73368|NCT02097043|"~     This study is a phase I clinical trial for evaluating the pharmacokinetics and~     safety/tolerability of DA-7218 in healthy male volunteers.~   "
73369|NCT02097030|"~     The objective of the study is to compare the overall subjective preference of filcon II 3~     daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A~     daily disposable conventional hydrogel contact lenses.~   "
73370|NCT02097017|"~     To examine whether application of lidocaine spray in cervical preparation for second~     trimester dilatation and evacuation alleviates pain and is superior to current protocol of~     preparation without analgesia and superior to placebo.~      Methods A prospective randomized placebo controlled trial consisting of three groups~        1. Lidocaine spray group (group 1)~        2. Placebo group (saline spray) (group 2)~        3. No intervention group (as currently in our protocol) (group 3)~             -  Women undergoing dilatation and Evacuation in the second trimester and are about~               to go cervical dilation with osmotic dilators(laminaria) will be invited to~               participate in the randomized placebo control trial comparing lidocaine spray,~               placebo (saline) or no application (as current protocol).~             -  Informed consent will be obtained from each participant~             -  After enrollment patient will be randomized into one of the three study arms by a~               computer program~             -  The patient will be placed in the lithotomy position and the cervix will be~               exposed using a sterile bivalve speculum.~             -  Pain will be assessed in 3 places using a visual analog pain scale 10(no pain) to~               100 (worst possible pain).~                0 after removal 15~             -  Group1 :after speculum insertion 4 puffs (40mg) of spray will be applied to the~               cervix and after a 2 minute wait laminaria will be inserted.~             -  Clinical data will be collected including age, parity, general health, Obstetric~               and gynecologic history.~             -  Primary outcome : difference in pain score immediately after speculum removal and~               10 minutes after speculum removal~             -  The protocol will not be repeated if a participant is to return for further~               laminaria insertion.~      Sample size A sample size was calculated assuming a target difference of 10 (smallest effect~     of clinical importance) between the baseline and post laminaria pain score at 15 minutes.~     Standard deviation was assumed to be 18 based on similar power. Assuming 80% power and a P~     value of 0.05 sample size of each group was calculated to be 51(5) and hence sample size of~     55 was determined .~      Participants~        -  Females aged 16 years and older about to undergo DE Inclusion criteria~        -  Informed consent~        -  Women with a fetus Crown rump length (CRL) greater than 10 weeks via ultrasound.~      Exclusion criteria~        -  CRL < 10 weeks~        -  Clinical Uterine size >22 weeks~        -  Fetus Bi Parietal Diameter > 50 mm~        -  Known amide allergy Withdrawal criteria~        -  Immediate adverse reaction to amides~   "
73371|NCT02097004|"~     A randomized, Open label, Single center, Prospective study to compare efficacy and safety of~     Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on~     Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological~     Response Induced by Entecavir~   "
73372|NCT02096991|"~     -  Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of~          estrogen.~        -  Previous studies reported that BPA exposure is associated with increased risk of~          cardiovascular diseases.~        -  Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is~          one of the well established source.~        -  The investigators hypothesis is that increased BPA exposure from canned beverage would~          disrupt normal physiology in a short term.~        -  In the present trial the investigators are to investigate whether increased BPA~          exposure by consuming canned beverage actually affect cardiovascular indices and~          epigenetic feature.~        -  For this aim, the investigators will conduct a cross-over trial.~   "
73373|NCT02096978|"~     The study will be conducted to compare two alternative techniques for dental implant~     placement. Both of the techniques - Osteotome and Conventional Drilling Techniques for the~     preparation of the implant sites (osteotomies) are accepted standards of care. The goal of~     the study will be to compare implant stabilities achieved with two techniques by measuring~     resonance frequency for each implant placed using the diagnostic device, the Osstell~     machine, that measures stiffness of the bone/implant system non-invasively. The data are~     represented in a quantitative value - implant stability quotient (ISQ), where a higher value~     indicated a higher implant stability. Since it has been well documented in the scientific~     literature that primary (at the time of implant placement) implant stability is a strong~     prerequisite for implant success (osseointegration and subsequent function on loading), the~     results of this study will guide the implant team in choosing the right surgical treatment~     protocol - the protocol that will be aimed for higher implant stability, and, therefore, for~     higher long-term implant success.~   "
73374|NCT02096965|"~     In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15~     mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase~     urine volume and reduce urine supersaturation and to be well tolerated by patients with~     kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM)~     regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of~     effect during the night. To this end, a higher dose is used in the morning, with a lower~     dose in the afternoon.~   "
73375|NCT02096952|"~     The purpose of this study is to determine whether methylphenidate hydrochloride extended~     release liquid formulation is safe and effective in the treatment of~     attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism~     spectrum disorders (ASD).~   "
73401|NCT02096601|"~     An open label phase I/IIa study to evaluate the safety and tolerability of 6 different~     doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if~     continuous delivery of levodopa and carbidopa can provide reduced variability in plasma~     concentration; to test and compare the PK profile of high and low concentrations of CD; to~     assess preliminary efficacy.~   "
73866|NCT02090504|"~     Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome~     (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a~     treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized~     double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to~     oxazepam in the treatment of alcohol withdrawal symptoms (AWS).~   "
73376|NCT02096939|"~     Patients with primary aldosteronism, which is the most prevalent form of secondary~     hypertension, have an increased rate of cardiovascular events, compared to patients with~     essential hypertension, even with equal severity of hypertension. This might be partially~     attributed to the association of increased aldosterone levels with insulin resistance. How~     this relation can be explained from a pathophysiological point of view, is insufficiently~     established.~      Recently, microvascular dysfunction has been proposed as a link between insulin resistance~     and hypertension. Loss of NO-mediated vasodilation is an important feature of microvascular~     dysfunction; in addition, an impaired insulin-mediated microvascular NO production has been~     suggested to underlie the reduction in insulin-stimulated glucose disposal that is~     characteristic of insulin-resistant states. Increased aldosterone levels are not only~     associated with insulin resistance, but also with endothelial dysfunction. In addition, they~     interfere with the vascular effects of insulin.~      Therefore, the investigators hypothesize that in patients with primary aldosteronism,~     increased aldosterone levels induce microvascular dysfunction through reduction of~     NO-availability, which contributes to the development of insulin resistance, and of~     hypertension, in addition to the sodium-retaining effects of aldosterone.~   "
73377|NCT02096926|"~     This is a single center placebo controlled, prospective, randomized study on healthy adults~     undergoing third molar surgery.~   "
73378|NCT02096913|"~     The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and~     feasibility of small molecule (Ibuprofen) mediated Rho-inhibition as putative~     neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety~     analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the~     feasibility of recruitment procedure, and oral administration of the compound within the~     multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the~     pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be~     investigated. Secondary endpoints will permit preliminary statements about effects on~     neuropathic pain, spasticity, and neurological function.~   "
73379|NCT02096900|"~     The purpose of this investigator-initiated study is to compare the efficacy of oral~     midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety~     at the time of separation, and ease of mask acceptance at induction in children. Subjects~     will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes~     prior to surgery. No placebo will be administered in this study. Subjects will be male and~     female children between 2 and 9 years of age. In total, subject participation will last~     approximately the duration of their preoperative, perioperative, and immediate postoperative~     period. A member of the research team will recruit subjects preoperatively in the operating~     room holding area prior to surgery. Consent will take place at the time of recruitment in~     the preoperative holding area following a detailed explanation of the study and medications~     involved in the study. Participants will be of ASA (American Society of Anesthesiologists)~     class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to~     remain inpatient for at least 23 hours postoperatively.~   "
73380|NCT02096887|"~     Patient's awareness of their risk factors for heart disease and their active involvement in~     their own management plan can help improve their adherence to treatment and their risk~     profile. The purpose of this study is to investigate the influence of patient education and~     awareness of heart disease risk factors on compliance to medication and lifestyle~     modification.~   "
73381|NCT02096874|"~     Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such~     as Avastin on retinal ischemia in the setting of diabetic macular edema.~   "
73382|NCT02096861|"~     This study is to assess noninferiority in efficacy and to assess overall safety of CT P13~     compared to Remicade in patients with active Crohn's disease up to Week 54.~   "
73383|NCT02096848|"~     Studies which describe the bacterial aetiology and antimicrobial susceptibility in AOM~     children in Latin America are scarce. Interestingly, when the MEF microbiology was analyzed~     among 1,108 children aged 2-92 months with OM between years 2002 and 2007, non-typable H.~     influenzae was the most common pathogen isolated from the MEF of children with a otitis~     media failing to appropriate antimicrobial therapy.~      PCV-7 (3 + 1 regimen) was introduced into the Costa Rican national immunization program in~     January 2009 and in August/September of 2011, it was changed for PCV 13 (-2+1 regimen).~     Following PCV-7 universal introduction in Costa Rica, between March of 2010 and January of~     2011, MEF samples from Costa Rican children with OM, having received 0-4 PCV 7 vaccine~     doses, were obtained via tympanocentesis (88%) or from spontaneous otorrhoea (12%). It was~     interesting to observed that among the initial 134 OM episodes, the most common bacterial~     pathogen identified was H. influenzae (55%) followed by S. pneumoniae (31%) and that among~     the S. pneumoniae episodes, 55% were already non-PCV-7 serotypes and that 25% of these~     isolates were multi-drug resistant.~      The primary objectives of the study are to analyze the effect of early universal utilization~     of PCV-13 in Costa Rican children with the number of H. influenzae and PCV-13- S. pneumoniae~     positive MEF cultures by comparing the data collected prospectively and by the same group of~     investigators that have collected the original data since 1992, from children for the~     post-PCV-13 introduction with anonymised information collected retrospectively pre-PCV-7~     data (1999-2004) during a transition period in which PCV-7 was used in only the private~     settings (2005-2008) and during universal use of PCV-7 (2009-September 2011).~   "
73384|NCT02096835|"~     The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in~     women scheduled for gynecologic laparoscopic surgery with general anesthesia.~   "
73385|NCT02096822|"~     Preterm infants undergo very frequent painful procedures during neonatal care particularly~     during the first few days. The support for the pain of the preterm is a priority for nurses~     and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose~     ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of~     sucrose is limited to 4 administrations per day which is insufficient compared to the~     average of daily painful procedures. So, validation of an effective non-pharmacological~     intervention to relieve or avoid pain is essential. Facilitated tucking alone has been~     validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no~     study looks for the benefit for pain relief of the association of non-nutritive sucking and~     facilitated tucking during heel stick procedure.~   "
73386|NCT02096809|"~     Objectives~        -  To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system~          1 week after implantation~        -  To evaluate the short term soft tissue healing and the long term skin reaction, with~          the new Cochlear BI300/BA400 implant system using the linear incision without~          subcutaneous tissue reduction.~        -  To produce reference data regarding the stability of the BI300/BA400 implant system.~      Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and~     bone quality eligible for bone anchored implant surgery.~      Intervention: Loading of the sound processor one week after surgery Main outcome measures:~     Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be~     assessed.~      It is hypothesized that implant loading can be performed one week after surgery without any~     changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around~     implant.~   "
73387|NCT02096796|"~     Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment~     Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood~     pressure in forearm muscle compartments. No strategies nor methods have been used to~     diminish the risk to suffer from arm pump within motor cross.~      This project aims to look at ergonomics of driving and its relationship with the occurrence~     of arm pump.~      The investigators will first investigate the experience of motor cross athletes with arm~     pump through motor cross federations in Belgium and The Netherlands (survey).~      Two groups of athletes will be selected (20 persons within each group) who will be invited~     to the motor cross track to investigate their hand grip strength, motor driving position,~     muscle activity.~   "
73388|NCT02096783|"~     This randomized pilot clinical trial studies the feasibility of a pre-operative and/or~     post-operative scripted sexual health informational intervention and how well it works in~     improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes~     and counseling options with patients may help improve sexual outcomes and/or anxiety after~     primary gynecologic cancer treatment.~   "
73389|NCT02096757|"~     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral~     supplementation will improve will improve systemic inflammation and patency of peripheral~     vascular intervention (PVI).~   "
73390|NCT02096744|"~     To establish the bioequivalence and adhesion properties of transdermal clonidine prepared~     with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with~     VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.~   "
73391|NCT02096731|"~     Background: Recent observational studies have reported possible arrhythmogenic effects with~     long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been~     associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object~     of a recent signal in trials of LABAs submitted for marketing approval.~      Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two~     long-acting bronchodilators as well as from monotherapy use of each of the long-acting~     bronchodilators.~      Methods: A series of population-based cohort studies, using both cohort and nested~     case-control analyses will be conducted using data from the United Kingdom's Clinical~     Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting~     bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary~     disease (COPD) and at least two years of baseline medical history information. The~     high-dimensional propensity score technique will be used to match new users of each~     long-acting bronchodilator and new users of two bronchodilators with comparable subjects~     from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction,~     stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed~     using time-dependent Cox proportional hazard regression models and conditional logistic~     regression models.~   "
73392|NCT02096718|"~     The primary objective of the current study is to investigate the influence of moderate to~     severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in~     comparison to a control group with normal renal function.~      The assessment of safety and tolerability will be an additional objective of this trial and~     will be evaluated by descriptive statistics.~   "
73393|NCT02096705|"~     The purpose is to determine if after 24 weeks of oral daily administration, there will be a~     greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with~     Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2~     diabetes.~   "
73394|NCT02096692|"~     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD~     System when used under specific MRI conditions.~   "
73395|NCT02096679|"~     Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in~     healthy male volunteers~   "
73396|NCT02096666|"~     This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and~     activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects~     with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal~     adenocarcinoma (Phase 2).~   "
73397|NCT02096653|"~     In this study, the investigators are attempting to determine whether intra- or~     extra-articular injections are more effective; the relative prevalence rate of~     intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular~     injections using fluoroscopy as the reference standard. 124 consecutive patients with~     mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3~     positive provocative maneuvers will be randomized to receive SI joint injections by 2~     different approaches.~      Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive~     landmark-guided injections into the tender area around the joint. In order to determine~     whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be~     done after the injection to ascertain the location of contrast spread. The primary outcome~     measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be~     followed at 3-months, while those who fail to obtain benefit will exit the study to receive~     alternative care.~   "
73398|NCT02096640|"~     The main purpose of this study is to examine if there are differences in postoperative~     inflammation following percutaneous dilatation tracheostomy versus surgical tracheostomy in~     intensive care unit patients.~   "
80555|NCT02003014|"~     To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos~     tablets) in combination with biguanides (for 12 months after the start of pioglitazone~     tablets treatment) in patients with type 2 diabetes mellitus.~   "
73402|NCT02096588|"~     Doxorubicin (Adriamycin), one of the drugs commonly used for the treatment of breast cancer,~     is in a class of medications called anthracyclines. Anthracyclines may cause heart damage~     that can lead to weakening of the heart muscle. This heart damage may happen right away or~     may occur many years after the anthracycline is given.~      Simvastatin is an oral medication approved by the FDA to lower cholesterol. Simvastatin is~     in a class of medications called statins. Some research has shown that statins may prevent~     heart damage that can be caused by anthracyclines like Doxorubicin (Adriamycin).~      The purpose of this study is to determine if taking simvastatin while receiving the~     chemotherapy Doxorubicin (Adriamycin) will minimize damage to the heart.~      This study is for women who will be receiving the anthracycline doxorubicin (Adriamycin) as~     part of their breast cancer treatment.~   "
73403|NCT02096575|"~     The purpose of this research is to study the effect of nitrous oxide on pain felt by women~     having a surgical termination at less than 11 weeks compared to pain felt by women receiving~     oral pain medications.~   "
73404|NCT02096562|"~     Outpatients who undergo knee surgery are designated two different clinical study groups.~     Group A receives common wrapping after surgery to the first postsurgical day and will be~     provided with compression stockings for the following 10 days, while group B only receives~     common wrapping and will not be provided with compression stockings.~      The investigators are going to investigate the effect of compression stockings on~     postsurgical swelling and formation of edema on outpatients.~   "
73405|NCT02096549|"~     During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility~     is essential to inject botulinum toxin to the right muscle. Because children with cerebral~     palsy are generally unable to control their movement, deep sedation is required during this~     painful procedure.~      Short-acting drugs such as propofol and remifentanil are widely used for pediatric~     anesthesia and sedation but still have possibility of over-sedation and associated~     complications due to their rather narrow therapeutic window. Therefore, objective scoring~     system to assess the level of sedation to provide an effective and safe sedation in~     children. Bispectral index (BIS) monitoring,an objective guidance of sedation might be~     helpful.~      The present study is to investigate the validity of the BIS monitoring during deep sedation~     of children with cerebral palsy for injection of botulinum toxin.~   "
73406|NCT02096536|"~     Vancomycin is already used for decades in neonates. However, there are remaining questions~     concerning vancomycin disposition in this population. The purpose of this study is first of~     all to perform a paired analysis of serum vancomycin concentrations using an immunoassay~     versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim~     to determine vancomycin protein binding and its covariates in neonates.~   "
73407|NCT02096523|"~     The goal of this study is to identify the platelet defect responsible for the bleeding in~     families from our inherited platelet disorders Israeli-Palestinian registry. The~     investigators plan to characterize platelet proteome expression after removing high~     abundance proteins. The investigators will compare the proteome of sick and healthy members~     of families with inherited platelet disorders, and identify and validate structural~     proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet~     disorders. The investigators expect to discover new key findings that allow better~     understanding of human platelet function and allow better diagnosis and treatment of~     patients with inherited platelet function disorders.~   "
73408|NCT02096510|"~     The aim of this study is to compare the effects of tablet treatment, circadian and combined~     circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and~     tissue responses to therapy.~   "
73409|NCT02096497|"~     Retrospective analysis to the course and branching pattern as well as surgically relevant~     inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction~     angiographies (DSA).~   "
73410|NCT02096484|"~     The study will examine the effectiveness of group metacognitive therapy in comparison with~     group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be~     randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy~     sessions of their respective treatment condition.~   "
73411|NCT02096471|"~     This phase II open label study will evaluate adolescents (≥ 16 years of age) and adults with~     neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor~     PD-0325901. The primary aim of the study will be to assess quantitative radiographic~     response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing~     schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration,~     and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive~     additional courses beyond course 8 only if there is at least 15% reduction in volume of the~     target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end~     of 12 courses can continue on therapy for up to an additional year (maximum of 24 total~     courses). However, subjects who do not achieve at least 15% reduction in volume of the~     target tumor after 8 courses (~8 months) will be considered treatment failures and taken off~     study.~      The Primary purpose of this protocol is to determine whether PD-0325901 results in objective~     radiographic responses based on volumetric MRI measurements in adolescents and adults with~     NF1 and growing or symptomatic inoperable PN.~      There are several secondary aims of this protocol:~      To evaluate the feasibility and toxicity of chronic PD-0325901 administration in this~     patient population~      To estimate the objective response rate of up to 2 non-target plexiform neurofibromas to~     PD-0325901by MRI~      To characterize the pharmacokinetic profile of PD-0325901 when administered to this patient~     population~      To characterize the pharmacodynamic profile of PD-0325901 when administered to this patient~     population using dermal neurofibromas as a surrogate for plexiform neurofibroma cells~      To characterize the activity of PD-0325901 on neurofibroma cell gene expression~      To characterize the activity of PD-0325901 on plasma cytokines and growth factors~      To correlate pERK levels to pharmacokinetic data and response~      To evaluate quality of life and pain during treatment with PD-0325901~      To validate the PedsQL NF1 QOL Module, a disease specific QOL scale, for use in this patient~     population, and~      To determine whether subjects who respond (≥20% objective radiographic response of target~     lesion by 12 courses) to PD-0325901 will maintain that response for 1 year one they come off~     therapy~   "
73412|NCT02096458|"~     The purpose of this study is to measure the in-vivo disintegration time of a single~     dexlansoprazole delayed-release orally disintegrating (OD) tablet.~   "
73448|NCT02095990|"~     To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce~     melasma on the face, using a split-face randomization design, evaluating the MASI Score from~     baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.~      To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the~     face.~      To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.~   "
73544|NCT02094716|"~     To determine and compare the safety and efficacy of PF-045 and PF-055 with that of vehicle~     in subjects with scabies. It is anticipated that a majority of subjects will require and~     receive a single treatment; however, those subjects not showing improvement at the follow-up~     visit 2 weeks after initial treatment will be treated a second time. Those subjects~     originally assigned to vehicle for the first treatment will receive a re-treatment with~     one of the active doses.~   "
73413|NCT02096445|"~     The aim of this project is to clinically evaluate a novel robot-assisted therapeutic~     approach to train sensorimotor hand function after stroke. It combines the profound~     experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in~     the task and training both the motor and the sensory system - with the advanced haptic~     robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of~     Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the~     simulation of virtual objects with various mechanical properties. In a randomized controlled~     clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy~     sessions, integrated seamlessly into their daily rehabilitation program, while 10 other~     patients will receive conventional therapy. The investigators will assess baseline~     performance in an initial clinical and robotic assessment, with another assessment at the~     end of the four-week period, and in follow-ups four weeks and six months later. The contents~     of the patient-tailored robotic therapy sessions will match those of the conventional~     therapy as closely as possible. This study will demonstrate the feasibility of including~     robotic therapy of hand function into the daily rehabilitation program, and investigate the~     acceptance from patients and therapists. The investigators expect increased training~     intensity during the robotic therapy session compared to conventional sessions with similar~     contents, as well as novel insights into the recovery process of both the motor and the~     sensory system during the four weeks of therapy, through advanced robotic assessments~     integrated into the training sessions. This project is a first step towards making such~     robotic therapy available to patients as integration into the conventional individual~     therapy program (e.g. for self-training), and towards transferring this technology to the~     home environment.~   "
73414|NCT02096432|"~     This project aims to develop and refine a suicide intervention protocol, and pilot test a~     culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese~     older adults. During the first phase of the study, the investigators plan to invite the~     community advisory board and key stakeholders to participate in the iterative design and~     refinement of the study protocol. During the second phase of the project and after the~     initial screening and based on a specific set of inclusion criteria, the investigators will~     invite U.S. Chinese older adult to participate in a pilot randomized control trial of a~     culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts~     in Chinese older adults. During the third phase of the project, the investigators plan to~     invite pilot intervention participants as well as key stakeholders and health care~     professionals on the cultural acceptability of the pilot intervention. Through the~     achievement of these objectives, the investigators will set the foundation to fully test a~     culturally adapted in-home intervention, which may be particularly suitable for Chinese~     older adults with suicidal thoughts as it addresses cultural-specific barriers and~     integrates care management within existing community services agencies using non-mental~     health professionals, including community health workers.~   "
73415|NCT02096419|"~     The purpose of this study is to determine whether continuous clopidogrel dose adjustment~     targeted after platelet function testing improves outcomes during 12 months of follow-up in~     acute coronary syndrome patients treated with coronary artery stenting and with determined~     high platelet reactivity on clopidogrel.~   "
73416|NCT02096406|"~     Coronary artery disease is a leading cause of death, hospitalization, and health care costs~     in developed nations. Coronary revascularization with coronary artery bypass graft (CABG)~     surgery improves the long term survival in patients with diabetes and multi-vessel disease.~     Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB)~     reduce mortality and subsequent cardiac events in patients with coronary artery disease~     undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data~     have suggested that pre-operative ACE administration is associated with an increased risk of~     post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies~     have failed to confirm these findings and further suggested ACE are associated with a~     reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients~     randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal~     group required significantly fewer vasopressors during cardiopulmonary bypass but more~     intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear~     whether ACEs should be held or continued immediately prior to CABG surgery and a survey of~     cardiac surgeons suggests that current clinical practice is divided. This pilot study aims~     to establish the feasibility of the study design and to determine the frequency of clinical~     endpoints among patients who continue and discontinue ACE prior to cardiac surgery.~   "
73417|NCT02096393|"~     This is a randomised control trial to assess the benefits of using patient specific~     instrumentation in total knee replacement surgery. Patient specific instrumentation is an~     individualised system for total knee replacement surgery. The system has been marketed and~     is already in use in some centres. The type of implant used remains the same but the sizing~     of the components, and alignment of the implant is expected to improve. This study assesses~     any improvement in implant alignment in using the patient specific instrumentation, any~     improved intra-operative outcomes and any long term clinical outcome improvements for~     patients.~   "
73418|NCT02096380|"~     Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to~     cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck~     cancer, and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also~     been reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction~     could delay the whole time of treatment and reduce the survival benefit are still unknown. A~     retrospective study of one cycle TPF induction chemotherapy by the investigators group (not~     yet published) could improve survival in NPC. It encourage us to conduct this clinical~     trial.~   "
73419|NCT02096367|"~     Balance disorders are very common after strokes and often last for long periods of time.~     Their origin is multifactorial and their impact on the daily lives of patients are~     particularly important, especially on gait.~      The vibration technology for rehabilitation was already studied in static posture with force~     plats but their impact on gait have yet to be evaluated.~      This present study aims at investigating the effects of vibrations applied by an approved~     medical device to the posterior neck muscles and the gluteus medius - major actors of~     proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during~     the chronic phase after stroke.~   "
73460|NCT02095834|"~     The goal of this clinical research study is to find the highest tolerable dose of~     carfilzomib when given in combination with bendamustine and dexamethasone. The safety of~     this drug combination will also be studied.~   "
73461|NCT02095821|"~     Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as~     humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily~     measured fibrinogen blood levels to prevent bleeding complications. However, data about the~     correlation of fibrinogen blood levels and function of the coagulation system during plasma~     exchange therapy is scarce. In the present study we examine blood fibrinogen levels and~     coagulation factors as well as thrombin clotting time in patients under plasma exchange~     therapy.~   "
73420|NCT02096354|"~     This two-stage study is designed to compare the safety and activity between RRx-001 against~     regorafenib followed by irinotecan-based therapies in a parallel comparative study.~      Patients who are suffering from advanced or metastatic (meaning the disease has spread)~     colorectal cancer are invited to participate in this study. There will be two groups of~     patients (Randomized, open label study), one of these will receive RRx-001 and the other one~     will receive regorafenib. If patients qualify to participate in this study, they will be~     randomly assigned to the 'interventional arm' where patients will receive the experimental~     drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care,~     Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance~     (1 out of 3) of receiving regorafenib.~      On progression in the first part of the study, provided ECOG performance status is adequate,~     and if clinically appropriate i.e. there are no absolute or relative contraindications in~     the opinion of the Investigator, all subjects will enter the second part of the study and~     receive irinotecan plus bevacizumab.~      Whether patients are given RRx-001 or regorafenib, they will also receive best supportive~     care, which includes treatments to help manage side effects and symptoms of cancer. This is~     an open label study, which means patients will know to which of these treatments, RRx-001 or~     regorafenib, they are assigned.~   "
73421|NCT02096341|"~     To investigate the dosage of RRx-001 by the subcutaneous route.~   "
73422|NCT02096328|"~     To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC~     during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas~     aeruginosa infection~   "
73423|NCT02096315|"~     To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis~     bronchiectasis caused by Pseudomonas aeruginosa infection.~   "
73424|NCT02096302|"~     The purpose of this study is to determine whether an infant formula supplemented with a new~     probiotic CECT7210, is effective in reducing the incidence of infections, specially the~     gastrointestinal ones.~   "
73425|NCT02096289|"~     This is a Phase I trial investigating the safety of using thioridazine in addition to~     cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.~   "
73426|NCT02096276|"~     The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes,~     including teratogenicity, in females intentionally or unintentionally exposed to Boostrix~     during their pregnancies. The Registry requires voluntary, prospective reporting of eligible~     pregnancies by patients and health care providers (HCPs). Data such as vaccination with~     Boostrix during pregnancy or within 28 days preceding conception, potential confounding~     factors (such as exposure to other medications) and information related to the outcome of~     the pregnancy will be collected prospectively.~   "
73427|NCT02096263|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4~     and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK~     Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.~   "
73428|NCT02096250|"~     The government of Haiti plans to introduce a flour fortification program. The aim of the~     project it to inform the authorities on the most suitable iron compound for this~     fortification program. For this purpose, iron absorption from wheat flour using different~     iron compounds will be investigated.~   "
73429|NCT02096237|"~     In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated~     with a method, called immune apheresis, that removes IgE from blood. In order to achieve~     this blood is taken continuously from the patient and then separated into plasma and blood~     cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically~     bound. The cleaned plasma re-joined with the blood cells is given back to the patient. In~     total each patient randomized to the apheresis group will undergo 3 treatments per week~     (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis~     treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of~     reducing IgE in plasma/serum by at least 50% measured before the first treatment in the~     first cycle and after the last treatment in the last treatment cycle. The new adsorber can~     be safely used in patients. A group of patients with conventional drug treatment and no~     apheresis treatment serves as control.~   "
73430|NCT02096224|"~     We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of~     catheter-related bladder discomfort.~   "
73431|NCT02096211|"~     This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years)~     information regarding the performance and safety of the commercially available 36mm CERAMAX®~     Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not~     previously involved in the IDE study for this device.~   "
73432|NCT02096198|"~     This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to~     10-years) information regarding the performance and safety of the commercially available~     36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that~     were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert~     component that articulates with a ceramic femoral head in the COC total hip replacement~     system)~   "
73447|NCT02096003|"~     The use of intrathecal opioids for analgesia in the setting of cesarean section has become~     standard obstetric anesthesia practice. Currently, two opioids are commonly used. These~     opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source~     of analgesia and act to reduce the stress response to surgery.~      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after~     cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use~     of this medication is associated with side effects such as pruritus and nausea and vomiting.~      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for~     cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,~     retrospective data became available that demonstrated its safety and efficacy for use during~     cesarean section.~      In order to fully elucidate the analgesic and side effect properties of hydromorphone for~     cesarean delivery, a prospective randomized, double blind study comparing morphine and~     hydromorphone is necessary. The investigators need to understand whether hydromorphone is as~     effective as morphine for analgesia after cesarean section, and whether it is associated~     with fewer or more side effects. The results of the study will allow providers to make~     educated decisions to better care for their patient.~   "
73433|NCT02096185|"~     Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where~     this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to~     assess that the abnormality has been removed and give an estimation of the distance from~     lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or~     not at the time. This study is designed to compare whether more accurate information about~     lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging~     compared to 2 dimensional conventional digital imaging which is the type of imaging~     currently used. This has the potential to prevent some patients requiring a second operation~     to remove more tissue if the margins of the specimen are still involved with tumour.~      The study involves x-raying the specimen under both conditions when it arrives from theatre.~     Only the 2D image will be reviewed at the time as is current practice. The 3D image will be~     reviewed later and the measurements for lesion to specimen margin compared. The lesion to~     margin measurement as recorded by the pathologist will be taken as the 'gold standard' and~     the imaging measurements will also be compared to that.~      In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin~     measurement because 3D can provide better visualisation of the lesion edges by removing the~     effect of superimposed tissue.~      The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide~     better lesion visualisation compared to 2 dimensional conventional digital imaging thus~     allowing more accurate lesion to margin measurement.~   "
73434|NCT02096172|"~     The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug~     metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).~   "
73435|NCT02096159|"~     The primary purpose of this study is to determine if routine use of prophylactic~     (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.~   "
73436|NCT02096146|"~     This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first~     tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly~     assigned to one of these two treatment options.~   "
73437|NCT02096133|"~     Patients with multiple sclerosis (MS) have an increased risk of developing a major~     depression. The investigators observed a protective effect of high vitamin D levels on the~     risk of depression in MS. This might be driven by the effect of vitamin D on the~     stress-axis. Therefore, the main goal of the present study is to assess whether high dose~     vitamin D supplementation results in a suppression of the stress-axis, as measured by~     decreased levels of cortisol.~   "
73438|NCT02096120|"~     The purpose of this study is to determine whether full mouth disinfection in combination~     with one week antibiotic amoxicillin plus metronidazole antibiotic therapy is improving~     periodontitis and disease activity of rheumatoid arthritis.~   "
73439|NCT02096107|"~     Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and~     steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and~     prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and~     allograft fibrosis.~   "
73440|NCT02096094|"~     Traditional bed bathing have been related to cross-infection. In order to avoid this~     complication, single-use products such as wipes impregnated with chlorhexidine use is~     increasing. Nevertheless among nursery staff concern about its side effects prevents its~     widespread use. The investigators want to know if there are any differences between the use~     of 2% chlorhexidine wipes and a placebo concerning side effects.~   "
73441|NCT02096081|"~     The purpose of this study is to show that two FDA-approved Botulinum toxin drugs called~     Xeomin® and Toxin II can reduce the severity of vertical lines (wrinkles) that appear~     between the eyebrows (called glabellar frown lines).~   "
73442|NCT02096068|"~     The drug Dexmedetomidine will be investigated in 72 patients (men and women) undergoing~     elective cardiac or abdominal surgery. The study medication will be administered~     perioperatively by intravenous infusion continuously (at the longest 48 h) to prevent/reduce~     the rate of Delirium and the incidence of postoperative cognitive deficit (POCD).~      A non-surgical control group of 15 ASA II/III- patients from Berlin and surrounding area is~     collected for measuring the learning experience during the cognitive testings. The~     participants are matched on age, education, and gender to the study patients.~      Cognitive testings are performed in patients of the study group (n= 72) and the control~     group (n= 15) to evaluate deficits in their cognitive areas (POCD (Postoperative cognitive~     deficit)) at three different time points up to three months.~   "
73443|NCT02096055|"~     The goal of this clinical research study is to compare different treatment schedules using~     the drug SGI-110 alone or in combination with other drugs. Researchers want to learn more~     about how these different treatment schedules may help to control AML. The safety of these~     treatments will also be studied.~   "
73444|NCT02096042|"~     This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2.~      The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab~     vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the~     combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the~     combination of brentuximab vedotin and azacytidine can help to control AML.~   "
73445|NCT02096029|"~     The purpose of this study is to evaluate the use of sampling of smoking cessation~     medications (nicotine patches and lozenges) among smokers seen in primary care settings.~     Half of study participants will be provided with samples of medication, to use however they~     wish; the other half will not be provided with these samples. All smokers will be advised to~     quit through routine contact with their physician. After the primary care contact, all~     participants will be contacted by phone for three brief follow-up interviews, which will~     involve answering questionnaires about their smoking habits.~   "
73446|NCT02096016|"~     The investigators have planned this project to evaluate the follow-up program after surgery~     due to cervical cancer and to explore the possibilities for different tests of Human~     Papilloma Virus (HPV) in contributing to the customization of the follow-up program.~      Purpose:~      The investigators effort is to provide the background for an evidence-based update of the~     follow-up program after surgery due to cervical cancer with the purpose of early diagnosis~     of recurrence affecting quality of life for as few women as possible.~   "
73545|NCT02094703|"~     The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for~     short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary~     tract infection in females.~   "
73449|NCT02095977|"~     A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE)~     database, which contains reports of adverse events involving medical devices6,9. The FDA~     updates the database every two months. A total of 107 Riata leads with reported inside-out~     insulation breaks were found, of which 105 were available for analysis. The average age of~     the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143~     inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out~     insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23~     were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32~     leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22~     of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor.~     Noise and other sensing issues were the most common signs of failure. Seven leads were found~     to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%)~     experienced inappropriate shocks of which 41% had abraded cables.~      A critical decision facing physicians is how to screen and manage patients who are found to~     have externalized cables. Externalized cables on fluoroscopy may precede any electrical~     abnormalities. Also noise may not be detected on all ICD models. A recent case report~     suggested that changes in lead parameters might be transient and may be missed. The lead may~     function normally as the high-voltage and pace-sense cables are covered with ETFE, which~     serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the~     reliability of this to withstand a high-energy shock is unknown. This may lead to failure of~     appropriate therapy for life threatening arrhythmias.~      The aim of this study is to screen patients with ICD leads that potentially could have~     multiple different failure mechanisms, including inside-out insulation breaks, to develop a~     novel new algorithm and methods to detect these defects, thereby enabling physicians to~     prevent complications from failure of these leads.~      It is hypothesized that current monitoring tools are insufficient for detecting the~     sometimes transient electrical failures of the Riata family of leads, and that additional~     device diagnostic information in combination with fluoroscopy may improve detection of~     electrical failures.~   "
73450|NCT02095964|"~     High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse~     cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial~     generation of nitric oxide (NO) and improves endothelial function and arterial~     vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with~     increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and~     anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the~     activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of~     endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and~     E-selectin[15].~      In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory~     markers in patients with cardiac syndrome X (CSX).~   "
73451|NCT02095951|"~     The study team will compare hospital length of stay (LOS) and attributable length of stay~     (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing~     short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for~     up to 72 hours) placed within 24 hours of admission(Group 1, Preemptive ELT) versus ELT~     placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of~     Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the~     treatment of CRI (suspected or proven) of the blood in children with central catheters.~     Participants will be enrolled from patients with hematologic/oncologic disorders and bone~     marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital~     of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be~     defined as the number of hospital days between first symptoms of Catheter-related infection~     (CRI) (or date of admission for those admitted with symptoms) and first negative blood~     culture.~      Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined~     above, placed within 24 hours of symptoms/admission (Arm 1) versus ELT placement at the time~     of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for~     the treatment of CRI (suspected or proven) of the blood in children with central catheters~     in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable~     LOS (ALOS) and therefore lower hospital costs.~   "
73452|NCT02095938|"~     1. Study rationale - Nielsen et al reported that after 6 weeks of amisulpride treatment,~          patients with schizophrenia showed an increase in the anticipation-related functional~          MRI signal. This suggested that amisulpride could affect the brain structures and that~          responses to amisulpride could be associated by the brain structures as seen previous~          studies about treatment response to antipsychotics and brain structures. But to date,~          no study has examined the impact of brain structure alterations on amisulpride~          treatment for schizophrenia and its potential clinical significance.~        2. Study Objectives 2-1. Primary: To show the differences of the baseline brain structures~          on the structural MRI between the Solian® treatment responders and the non-responders~          2-2. Secondary: To show the differences of the baseline polymorphisms of COMT and BDNF~          with molecular genetic analysis between the Solian® treatment responders and the~          non-responders responder defined by PANSS. To find out the correlates of baseline brain~          structures with symptom severity of schizophrenia at baseline; symptom severity defined~          by CGI-S and PANSS. To assess psychotic symptom improvement after 8th week of Solian®~          treatment using PANSS, SANS, SAPS and CGI. To assess safety after 8th week of Solian®~          treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs. To report~          all serious adverse event within 24hrs regardless of relationship to investigational~          product.~        3. Study Design: Prospective/ Open label/ Interventional/ Controlled~        4. Evaluation Criteria:~      5-1. Primary endpoints: Brain structures on the structural MRI will be observed before the~     treatment starts. Based on the clinical response after treatment, patients will be divided~     in the two different groups as follow and their baseline brain structure of will be~     compared. Treatment responders and non-responders.~      5-2. Secondary endpoints: The relationship of baseline brain structures with symptom~     severity of schizophrenia. Severity will be determined by CGI-S and PANSS at baseline. The~     differences of the polymorphisms of COMT and BDNF with molecular genetic analysis using~     patients' peripheral blood, especially leukocytes, between the treatment responders and the~     non-responders. Efficacy - PANSS, SANS, SAPS, CGI. Safety - Barnes akathisia scale,~     Simpson-Angus scale, Vital signs~   "
73453|NCT02095925|"~     Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism,~     collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer~     patients have been previously developed by the groups of Khorana and Vienna CATS. However,~     routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently~     not recommended. In the investigators prospective, observational cohort study, the~     investigators aim to identify cancer patients at high risk for VTE based on clinical~     characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing~     microparticles.~   "
73454|NCT02095912|"~     To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ~     transplant recipients.~   "
73455|NCT02095899|"~     The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain~     in patients with a post thoracotomy pain syndrome.~   "
73456|NCT02095886|"~     The purpose of this study is to select the best dose level (amount of drug given) and best~     formulation of the study drug (BMS-955176) to develop further.~   "
73457|NCT02095873|"~     The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are~     effective in improving metabolic and vascular health.~   "
73458|NCT02095860|"~     The purpose of this study is to assess the effect of a high fat meal and light meal on the~     blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs~     as a fixed-dose combination in healthy subjects.~   "
73459|NCT02095847|"~     The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can~     be used to help guide tumor removal during a hysterectomy.~   "
73462|NCT02095808|"~     The purpose of this research study is to develop a method of using magnetic resonance~     imaging (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3~     centimeters). A pulmonary nodule is a mass or growth on the lung. An MRI is a scanning~     device that uses magnets to make images (pictures) of the body. This study is being done to~     determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn~     sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel~     is being investigated by using a natural, slightly modified, sugar solution (13C-glucose)~     and studying a small sample of the tumor once it is removed at the time of surgery.~   "
73463|NCT02095795|"~     The main objective of the present study was to compare the effects of exoskeleton devices~     used in electromechanical-assisted gait training after stroke compared to over ground~     conventional physical therapy in a single blind research.~      The second objective is to research when the devices can be used with the best chance of~     success in the functional recovery of gait in people who are unable to walk independently~     after stroke.~   "
73464|NCT02095782|"~     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of~     intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and~     erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant~     activating EGFR mutation.~   "
73465|NCT02095769|"~     The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx)~     Testing for elderly and disabled patients can help physicians manage patient medication~     regimens and assess if the testing has an effect on reducing adverse drug events,~     hospitalizations, and emergency department visits.~      The way an individual processes or metabolizes a drug is in part determined by their genes,~     and there is known to be genetic variation from one human to another. The study of the way~     in which genes affect an individual's response to drugs is known as Pharmacogenomics.~   "
73466|NCT02095756|"~     The purpose of this study is to evaluate the efficacy and safety of a combination of~     non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone~     for the treatment of facial melasma.~   "
73467|NCT02095743|"~     Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in~     case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its~     toxicity toward veins, chemotherapy must be administered through a central venous device.~     Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central~     Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week~     and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port~     is subcutaneous and lets patients lead a normal life, but its implant and explant require a~     cutaneous incision with possible complications (bleeding, pain, infection). For both venous~     devices, complications such as thrombosis or infection may happen. Published data comparing~     the two devices are heterogeneous and do not often distinguish patients treated for~     different diseases at various stages. Empirically in daily practice, for long term use (>6~     months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC~     line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy~     usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to~     the other for these patients.~      The aim of this study is to prospectively compare the patients' satisfaction and tolerance~     of each of the two devices.~   "
73468|NCT02095730|"~     The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in~     a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.~   "
73469|NCT02095717|"~     Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus~     Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic~     castration resistant. Assess time to progression (time to progression) of metastatic disease~     (from first day of treatment in the trial).~   "
73470|NCT02095704|"~     Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an~     orally administered solid dosage form. The aim of this study was to evaluate the~     pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in~     Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics~     parameters, investigators trend to propose a method to estimate in vivo dissolution time and~     dissolution kinetics of solid dosage form.~   "
73471|NCT02095691|"~     This is a prospective, multi-center, non-randomized, feasibility study to assess the safety~     and effectiveness of renal artery sympathetic denervation using the investigational devices~     in subjects with resistant hypertension.~   "
73472|NCT02095678|"~     The primary objective of this study is to develop and validate simultaneous free-breathing~     4D fat and water quantification and quantitative dynamic contrast enhanced perfusion in the~     liver. Secondary aims include developing and validating free breathing quantification of~     relaxation parameters T1 and T2, and developing and validating a minimal breath-hold (< 8 s)~     high quality diffusion exam using highly accelerated steady state diffusion imaging~     sequences. Investigators aim to scan 100 subjects receiving liver biopsies as a part of~     their standard care and another 70 subjects with known benign lesions. The study is greater~     than minimal risk.~   "
73473|NCT02095665|"~     Ureteric stents are used often following ureteroscopy for prevention of obstruction from~     edema and or stone fragments. They are often associated with pain, voiding often, the need~     to urinate quickly and finding blood in the urine called lower urinary tract symptoms or~     LUTS for short. There is randomized studies showing the efficacy of α-blockers such as~     tamsulosin in relieving stent symptoms (pain and LUTS). There is emerging but limited~     evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB)~     have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to~     decrease OAB symptoms.~      Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in~     treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side~     effects like dry mouth, constipation, blurred vision and cognitive impairment. This may~     limit their use in some populations. Mirabegron is well-tolerated with a good safety profile~     and therefore may be useful in treating stent symptoms without the bothersome side effects~     commonly seen with antimuscarinic medications. .~      The investigators hypothesize that mirabegron is effective in decreasing ureteral stent~     related LUTS and pain.~   "
73477|NCT02095600|"~     Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known~     procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually~     achieved using stereotactic surgical procedures.~      Radiosurgery of invisible targets to treat movement disorders and intractable pain are still~     the domain of frame-based procedures, due to the need of a solid reference system registered~     to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of~     stereotactic atlases.~      In this study we want to utilize a mathematical method that uses atlas-derived stereotactic~     coordinates to perform frameless images-guided radiosurgery of such functional targets~     Particularly the aim of the present study is to investigate both the efficacy and the safety~     of the methodology to treat upper limb and hand tremor in elderly or in patients which are~     not ot susceptible of surgical procedures. For these reasons a dose escalation prospective~     trial have been designed.~   "
73478|NCT02095587|"~     To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to~     subjects with chronic hepatic impairment and in matched healthy subjects.~   "
73479|NCT02095574|"~     A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with~     Non-Hodgkin's Lymphoma.~   "
73480|NCT02095561|"~     Cervical cancer is a leading cause of mortality among women in developing countries. A key~     factor has been the failure to achieve good coverage. The development in the last years of~     HPV-DNA based tests has changed the scenario, because it combines a high performance to~     detect disease with a reduction of screening frequency. Through self-testing, HPV testing~     has the potential of reducing social and health service barriers faced by women to access~     screening.~      This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical~     cancer mortality rates and where HPV testing has been introduced as a primary screening test~     for all women attending public health sector. The study was conducted between July~     2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol~     was approved by the institutional review committees of the Ministry of Health of Jujuy.~      This trial is a randomized by population clusters study that aims to assess the~     effectiveness of self-testing to increase coverage. The aims of this study are: a) to assess~     the self-test effectiveness to increase the participation of women in screening programs, b)~     to assess the self-test acceptability by women, c) to assess HPV self-test effectiveness~     measurement for the detection of CIN2+ lesions against cytology in primary screening.~      An overall number of 200 community health workers (CHWs) from the Primary Health Care System~     (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST)~     and Conventional Sample Group (CS):~        1. ST Group: CHWs will invite eligible women of their area to choose between doing a~          self-test or having a conventional sample taken by a health professional of the closest~          health care center.~        2. CS Group: CHWs will invite eligible women in their area to have a conventional sample~          taken by a health care professional of the nearest health care center.~      In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in~     primary screening, all the women in the Self-test Group who have decided to do the self-test~     and all the women of 30 years of age and older that were screened with cytology by the~     provincial program for the prevention of cervical cancer in 2011 will be considered.~      A database built specifically for the study will be used; it will hold the list of eligible~     women to participate in the study. The records of women of 30 years of age and older~     residing in the areas included in the study will be imported from the PHCS databases.~      In addition, the data surveyed by the study will be uploaded: randomization Group, presence~     of the woman at home during the CHW's visit, agreement to participate in the study,~     realization of self-test (in the corresponding group), and if appropriate, reasons for not~     doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on~     SITAM, (link of data done as from the identity card number).~      Data Analysis~      Self-test acceptability: Acceptability is defined as the number of women accepting the~     self-test against the number of women offered the option between the self-test and the~     conventional sample (proportion of women accepting the self-test). The acceptability in this~     population will be estimated as the average of acceptabilities calculated by CHW, as to~     control the impact of the CHWs on acceptability and reach an appropriate variance estimate.~     Besides, the variability introduced by the CHWs on acceptability will be studied and the~     results obtained by male and female CHWs will be compared, as well as those obtained by the~     CHWs in rural and urban areas.~      Self-test effectiveness to enhance participation of women in screening and diagnosis: There~     will be a comparison of the percentage of women that did the HPV test in the Self-test group~     and the Conventional sample group. Three different coverage indicators will be considered~     for every CHW. These will be defined as the number of women screened within the field work~     regarding:~        1. The number of women reached by the CHW who accepted participating in the study.~        2. The number of eligible women for that CHW (regardless of whether the CHW was able to~          contact them or not).~      The effect of the strategy (offering the self-test option against promotion of the~     conventional sample) will be estimated for each one of the coverage measures using a means~     difference test or a non-parametric test for independent samples.~      CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to~     detect CIN2+ will be estimated as the detection rates difference and as the detection rates~     ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of~     women who did the self-test against the total number of women in the province of Jujuy that~     were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.~   "
73481|NCT02095548|"~     The purpose of this study is to find the optimal dose of SM04690 that can be safely given by~     intra-articular injection into the target knee joint of subjects with moderate to severe~     osteoarthritis.~   "
73482|NCT02095535|"~     Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic~     solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before~     starting the anesthetic procedure. It is not known how much time is needed for the solution~     to completely dry. The investigators aim to determine this.~      As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be~     using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep~     dries it gives off less and less vapour. The investigators will use this diminishing vapour~     concentration to determine when drying is complete.~   "
73483|NCT02095522|"~     Colchicine has antiinflammatory properties. It has been shown to be effective in improving~     outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to~     assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI~     Patients.~      Study Hypothesis: There will be a significant difference on the RH-PAT levels of the~     patients who were in treated with colchicine versus the placebo group Study design and~     patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation~     Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo~     controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited~     during their hospitalization before cardiac catheterization. All patients will sign an~     informed consent.~      Primary outcome will be the improvement in endothelial function between baseline and after 1~     month in both groups~   "
73484|NCT02095509|"~     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically~     ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered~     either as a continuous intravenous infusion or subcutaneous bolus once daily.~      To investigate possible ongoing coagulation by coagulation markers during antithrombotic~     therapy with standard doses of enoxaparin~   "
73485|NCT02095496|"~     Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known~     factor in this deterioration.The investigators hypothesize that close-loop ventilation mode~     (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the~     patient needs.~   "
73486|NCT02095470|"~     new glidoscope was tested on 401 patients~   "
73487|NCT02095457|"~     Scientific Background: Inherent gaps exist between the worlds of research and clinical~     therapy, especially in mental-health systems. Developed as an important strategy aimed to~     bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a~     method devised for systematic ongoing quantitative measurements used in diverse clinical~     practices, from psychotherapies to psychiatric management. The efficacy of this approach has~     been repeatedly demonstrated in various measures, such as satisfaction with treatment by~     patients and therapists, lower drop-out rates, symptomatic benefits, and more.~      Objectives: The aim of the current study is to test the feasibility and the clinical~     benefits of implementation of a Routine Outcome Monitoring System in a public clinical~     center, as a pioneering project in Israel, at the Shalvata Mental Health Center.~      Working Hypotheses: Incorporation of a ROM system in routine clinical practice is~     hypothesized to improve patients' and therapists' overall satisfaction, allow for early~     detection and intervention in therapeutic raptures, decrease drop-out rates, and improve~     various clinical outcome measures.~      Methods: The suggested study is a two-stage (implementation and intervention) open trial.~     900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention~     (ROM) and control groups. Assessment questionnaires will be filled periodically using~     'CORE-NET', a computerized system enabling repeated measurements and feedback in a~     user-friendly and efficient manner.~      Data Analysis: The evaluation of the differential influence of monitoring processes on~     overall efficiency as compared to control group will be tested using Multiple Analysis of~     Variance (MANOVA). The predictive value of possible variables on process and outcome of~     therapy will be assessed using stratified regression analyses. The possible causal effects~     between specific lagged variables will be assessed using Hierarchical Linear Modeling and~     Time Series Analysis.~      Contribution: This pioneering study is the first in Israel to offer a routine systematic~     evaluation of therapeutic processes, as well as assessing its clinical effects.~     Consequently, a large and meaningful data-set will emerge, enabling significant enrichment~     of our evidence-based understanding of therapeutic processes.~   "
73488|NCT02095444|"~     The purpose of this study is to determine whether human menstrual blood-derived stem cells~     are effective in the treatment of infection of H7N9 virus caused acute lung injury.~   "
73489|NCT02095431|"~     Acute kidney injury (AKI), is a common complication of patients undergoing liver~     transplantation. Timing and definition of AKI, usually based on serum creatinine, have been~     inaccurate and inconsistent.~      We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to~     provide information on the risk of progression of AKI, the need for RRT and mortality.~   "
73506|NCT02095210|"~     This is an open-labeled, exploratory, single center study. Patients with a big primary~     breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression~     determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study.~     A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and~     diagnosis of possible metastases. Each subject will receive a single injection of the~     investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or~     metastases and in normal organs. The investigations will be repeated after HER2 directed~     therapy.~   "
73546|NCT02094690|"~     The purpose of this study is to assess the effect of two protocols of physiotherapeutic~     exercises in the maintenance and/or increase of the mandibular range of movement in patients~     suffering from head and neck cancer (HNC) who are undergoing radiotherapy.~   "
73490|NCT02095418|"~     With improvements in patient and graft survival, increasing attention has been placed on~     complications that contribute to long-term patient morbidity and mortality. New-onset~     diabetes after transplantation (NODAT) is a common complication of solid-organ~     transplantation, and is a strong predictor of graft failure and cardiovascular mortality in~     the transplant population. Risk factors for NODAT in transplant recipients are similar to~     those in non-transplant patients, but transplant-specific risk factors such as hepatitis C~     (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT~     pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the~     aggravation of insulin resistance; however several studies have displayed deleterious~     effects on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to~     improve glucose tolerance must be measured and defined from long term perspective.~      As recipients of organ transplants survive longer, the complications of NODAT have assumed~     greater importance; therefore, we designed a prospective study to compare the safety and~     efficacy of early versus late withdrawal of corticosteroids after liver transplantation.~   "
73491|NCT02095405|"~     Stimulants and drugs are often associated with cardiac effects. Caffeine, a therapeutic~     xanthine, has been described as a sympathomimetic and has shown to have stimulatory effects~     on the heart. Patients with symptomatic cardiac arrhythmias are generally informed by their~     physician to stop or significantly reduce caffeine intake. However, in spite of numerous~     reports that have reviewed the cardiac effects of caffeine, it remains unclear to what~     extent this stimulant may be detrimental, and what subgroups of patients may be most~     vulnerable. The investigators propose to evaluate the effects of caffeine in patients with~     previously diagnosed cardiac arrhythmias. The results of our report will provide important~     new information for physicians and patients regarding the effects of caffeine on symptomatic~     cardiac arrhythmias.~   "
73492|NCT02095392|"~     The study was conducted to investigate the effect of soluble phosphate in combination with~     different calcium doses on calcium and phosphorus metabolism and further physiological~     parameters in healthy subjects. The main aim of the study is to investigate the influence of~     a soluble phosphate supplementation on the fasting blood phosphate concentration and the~     dependency of an additional calcium intake.~   "
73493|NCT02095379|"~     In this study, the investigators aim to investigate the prevalence and clinical course of~     oligosecretary myeloma.~   "
73494|NCT02095366|"~     Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute~     traumatic pain in prehospital and Emergency departments (ED).~      The investigators hypothesize that IN administration of Sufentanil is equal as compared with~     Intra veinous (IV) administration of Morphine wich is widely recommended in ED.~      The investigators study is a multicentric, comparative, randomized, double-blind,~     double-placebo study, comparing quality of analgesia in both groups 30 minutes after first~     administration of opiates.~      The investigators also asses side effects and patient satisfaction in both groups.~   "
73495|NCT02095353|"~     The investigators propose to analyze the perfusion (blood flow) characteristics of blood~     tumors. The investigators will be comparing the use of two contrast agents in this study.~   "
73496|NCT02095340|"~     The purpose of this study is to expand our understanding of the intergenerational~     transmission of cognitive risk for childhood anxiety disorders by examining whether changes~     in maternal interpretations of situations result in changes in child interpretations and~     child anxiety.~   "
73497|NCT02095327|"~     The purpose of our study is to better understand how caregivers of individuals with dementia~     cope with their family member's illness. If you are eligible for the study and would like to~     participate, we will schedule a one-time phone interview, which will last approximately 2~     hours for which you will be compensated for your time.~   "
73498|NCT02095314|"~     Measure antibody persistence prior to booster administration of Pentabio vaccine.~   "
73499|NCT02095301|"~     The objective of this study is to assess the effects of an herbal extract on mental energy~     in healthy human subjects.~   "
73500|NCT02095288|"~     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated~     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.~     Global deletion of mPGES-1 in mice suppresses PGE2 and augments PGI2 by PGH2 substrate~     rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a~     predisposition to thrombogenesis and hypertension. However, cell-specific deletion of~     mPGES-1 reveals that the predominant substrate rediversion product amongst the~     prostaglandins varies by cell type, complicating drug development. We have developed an~     ultra performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique~     that allows the quantification of a wide range of lipids beyond the prostaglandin pathway~     (leukotrienes, anandamide and the 2-arachidonylglycerol cascades).~      This study is designed to examine different pathway interventions from the arachidonic acid~     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human~     blood in vitro (Part A) and ex vivo (Part B). In Part A, whole human blood will be donated~     by healthy volunteers and treated with screening compounds in vitro (outside of the body).~     Experiments will be performed to measure an array of lipids in plasma and serum from~     pre-stimulated whole blood treated with a single or a combination of the test compounds.~      This study may reveal pathways previously unknown to be affected by the existing~     anti-inflammatory drugs and drug candidates, and will possibly suggest new indications~     and/or side effects.~   "
73515|NCT02095093|"~     Leg length discrepancies following total hip arthroplasty have been associated with nerve~     palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to~     poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset~     following total hip arthroplasty has been linked to decreased range of motion and abductor~     muscle strength, impingement, limping, higher dislocation rates, increased polyethylene~     wear, and loosening of implants. Computer navigation has shown to improve the accuracy of~     leg length and hip offset during total hip arthroplasty. The investigators research~     objective is to prove the accuracy of the Intellijoint HIP™ system for determining leg~     length and hip offset. The investigators hypothesis was that Intellijoint HIP™, an imageless~     intraoperative intelligent instrument, could improve the accuracy of leg length and hip~     offset during primary total hip arthroplasty. The investigators plan to study this~     hypothesis in humans by comparing the leg length and hip offset discrepancies produced with~     Intellijoint HIP™ to the standard at the investigators institution, which is a pin and~     outrigger system.~   "
73501|NCT02095275|"~     B-type natriuretic peptide (BNP) is rapidly released by the ventricles of the heart in~     response to myocardial stretch. This cardiac neurohormone is mostly elevated in patients~     with fluid overload or myocardium dysfunction. BNP is a very useful and important marker. It~     can predict mortality and cardiac events in patients in the ICU setting. In stable~     hemodialysis patients with normal LV function on echocardiography, high BNP levels are~     likely the result of blood volume expansion and require reduction in postdialysis dry~     weight.~      In the past, there were many methods to evaluate fluid status. Some are not reliable such as~     central venous pressure or physical examination. Some are invasive and expensive such as~     Swan Ganz、PiCCO catheter or bioimpedance device. Nevertheless, About the relationship~     between BNP and fluid status, a study found a significant relation between~     bioimpedance-derived body composition (BC) (fluid distribution) parameters and BNP~     concentrations. This relationship was independent of the cardiac history of the patient and~     suggests that the natriuretic peptide levels are to some degree modifiable by changing a~     patient's fluid distribution.~      In this study, the investigators want to observe that if the level of BNP can predict the~     occurrence of acute kidney injury and the need of renal replacement therapy. Besides, the~     investigators also want to see if BNP can be a useful and convenient marker to guide~     adjustment of optimal fluid status and then to improve outcome.~   "
73502|NCT02095262|"~     Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there~     being no such sound in the external world. It is prevalent and for many individual is a~     distressing condition. Recent advances in the understanding of changes in the hearing brain~     and their relation to tinnitus perception has led to a focus on forms of active auditory~     training which might provide effective techniques for tinnitus management. Our recent trial~     of auditory training provided evidence that training using sounds where there is no hearing~     loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there~     is some level of hearing loss. Our next challenge is to build on this finding in ways that~     might maximize the benefits we observe.~      The training software we used previously was developed for use with children. Past~     participants have given mixed reviews of this software. While some enjoyed the training or~     found it soporific, others reported that they found it too monotonous and un-motivating. We~     therefore wish to explore the impact of different game mechanics in the delivery of auditory~     training and have designed two different interactive games in the context of training for~     tinnitus benefit. These games will deliver the same type of auditory training as the~     software we currently use, but should be intrinsically motivating, i.e. be a game that the~     people are motivated to play irrespective of any potential benefit for tinnitus. The game we~     previously used is reactive, i.e. the sounds play and the player selects what they think is~     the correct answer (odd one out).~      The two new games we wish to test can be described as interactive, i.e. players control the~     sound delivery and actively seek the correct answer: this may have additional benefit for~     tinnitus.~   "
73503|NCT02095249|"~     Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006,~     greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada~     with more than 32,000 men dying of their disease. Using the prognostic variables of~     T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score~     (GS), men with localized prostate cancer are placed in low, intermediate and high-risk~     groupings. Usually this is treated with surgery, radiation therapy, hormone therapy and/or~     watchful waiting (also known as active surveillance). While these treatments are quite~     effective, tumours are likely to recur in about 40% of cases. There is a need for additional~     prostate cancer treatments. To address this need, many experimental therapies are being~     developed and tested in mice with prostate tumors. This includes the study of aggressive~     prostate cancer cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen~     deprived cells, which may be the ones most likely to re-grow into a tumour or spread~     throughout the body. Researchers want to try and isolate these special cells from the~     prostate after surgery to study their features, and to see if they can re-grow as solid~     tumours in mice. Researchers would like to test whether the prostate cancer stem cells are~     more resistant or less resistant to treatments. This will allow researchers to study and~     test new treatments that specifically target resistant and aggressive prostate cancer cells.~     The investigators hypothesize that marker-defined TIC cells or hypoxic cancer cells have~     unique genetics in primary prostate cancers and are relatively chemo- and radio-resistant.~   "
73504|NCT02095236|"~     Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in~     close proximity of the tumor. During a radiotherapy treatment session image and/or signal~     acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging~     or by specialized signal detectors The data will help to characterize tumor and organ motion~     during one treatment session which may in fact have impact on dose distribution~   "
73505|NCT02095223|"~     Muscle inhibition prevents optimal contraction of the quadriceps muscle due to changes in~     the nervous system after knee joint injury. Current treatments for muscle inhibition at this~     time include knee joint cryotherapy and electric stimulation prior to exercise. These~     treatments, in addition to strengthening exercises, have shown improvements in the quality~     and strength of muscle contractions however, they have a short window of effectiveness.~     Electromyographic Biofeedback is proven to be useful in improving quadriceps strength but~     the mechanism of action remains somewhat unclear. Therefore, the purpose of this~     investigation is to compare the effectiveness of electromyographic biofeedback supplemented~     exercise when compared to traditional exercise on quadriceps muscle function in individuals~     with a history of knee injury and current evidence of quadriceps inhibition. We hypothesize~     that 14 days of electromyographic biofeedback supplemented exercise will lead to larger~     gains in quadriceps activation when compared to traditional exercise.~      Thirty 18-40 year old participants with a history of knee injury and current evidence of~     quadriceps muscle inhibition will be enrolled in this single blind randomized controlled~     trial. Participants will provide written consent prior to all study procedures. Following~     enrollment, participants will be asked complete questionnaires related to knee related~     function, current levels of pain, and current activity level followed by completion of~     baseline measurements.~        1. We will use the superimposed burst technique to quadriceps muscle activation.~        2. We will measure the Hoffmann reflex response of the quadriceps with surface~          electromyography. We will measure this signal with surface electromyography electrodes~          that record the activity of the quadriceps muscle through the skin.~      Participants in both groups will be instructed on a 14 day home exercise protocol on the day~     of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing~     and weight bearing quadriceps strengthening. Compliance will be monitored via a daily~     exercise diary which will be collected at the end of the study protocol.~      Quadriceps central activation ratio, active motor threshold and Hoffmann reflex will be~     reported descriptively. Pre-intervention and post 14 day intervention quadriceps central~     activation ratio and Hoffmann reflex will be compared between traditional exercise and~     Biofeedback supplemented exercise~   "
73547|NCT02094677|"~     The objective of the study is to compare the overall subjective preference between two Daily~     Disposable hydrogel lenses when refitted into a third hydrogel lens.~   "
75093|NCT02074423|"~     The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract~     (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a~     standard meal composed of white bread, in healthy male and female volunteers.~   "
73507|NCT02095197|"~     Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per~     year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or~     foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck,~     scapula or arm. The diagnosis of radicular pain is made clinically by history and physical~     examination, supported by imaging studies and electrodiagnostic tests. No study has compared~     the differences in pain, medication utilization, functional outcomes, or patient~     satisfaction between interlaminar and targeted epidural injections in the cervical spine. In~     theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk~     of accidental vascular trespass or disc penetration during the procedure, and far less risk~     of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as~     compared with the interlaminar technique. The investigators hypothesize that this technique~     results in superior pain control, decreased medication use, improved function and fewer~     repeat injections. This data could improve patient safety and affect the evolving treatment~     guidelines for cervical epidural injections.~   "
73508|NCT02095184|"~     More than three quarter of patients with breast cancer are treated by hormone pills called~     tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production.~     This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal~     women. The female hormone estrogen is an important hormone for the growth of breast cancer~     cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food~     and Drug Administration (FDA). They have been used since 2005 to treat women with early~     stage breast cancer.~      When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to~     successfully shrink breast cancer tumors in most patients. In over 50% of patients,~     anastrozole and letrozole when given for about 4 months also helped to improve surgery~     outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole~     before surgery can help the doctor decide whether that patient needs additional~     chemotherapy.~      One of the things may influence the level of hormone is body weight. It has been previously~     shown that postmenopausal women with higher body fat have higher level of female hormone as~     well as an increased risk of breast cancer. This is likely due to an increase in aromatase~     activity in the fatty tissue. However, at the current time AIs are used at the same doses in~     all women with breast cancer no matter whether they have different body weight. Currently,~     we do not know for certain whether the same doses of AIs work as well in patients with~     higher body fat compared to patients with less body fat.~      The purpose of this study is to see if women with higher body fat respond differently to AI~     treatment compared to women with lower body fat.~   "
73509|NCT02095171|"~     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX002 in approximately 40 healthy subjects.~   "
73510|NCT02095158|"~     This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen~     chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with~     rosacea.~   "
73511|NCT02095145|"~     This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth~     in patients with prostate cancer that is limited to a certain part of the body (localized),~     who have chosen observation as their treatment plan. The use of pomegranate-extract pill may~     slow disease progression in patients with localized prostate cancer.~   "
73512|NCT02095132|"~     This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and~     irinotecan hydrochloride in treating younger patients with solid tumors that have come back~     or that have not responded to standard therapy. WEE1 inhibitor MK-1775 and irinotecan~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
73513|NCT02095119|"~     The following is an open label, non comparative, pilot study of palliative treatment as a~     second, third line or more of treatment in patients with recurrent, persistent or Metastatic~     Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating~     the response (defined as: Complete, partial or stable disease) to treatment with a~     Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent~     every 3 weeks for patients with good renal function (Creatinine clearance => 60) or~     Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60).~      Secondary objectives consist of evaluating disease-free survival, overall survival and~     assess patient tolerance to treatment with Nimotuzumab.~   "
73514|NCT02095106|"~     Distal radius fractures are one of the most commonly seen fractures in children.~     Traditionally, minimally angulated or non-displaced distal radius fractures are treated with~     short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts~     used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast~     gets wet, it must be removed and replaced. In general, waterproof casting has been shown to~     improve patient comfort and overall satisfaction.~      We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the~     treatment of minimally angulated distal radius fractures in children using a randomized,~     controlled, cross-over study design. We will include patients between 4 and 14 years of age~     with minimally angulated distal radius fractures (<15 degrees of angulation on sagittal or~     coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility~     within 7 days of injury. As determined by a power analysis, a total of 26 patients will be~     enrolled in the study.~      Patients eligible for the study will be randomized into one of two equally sized (n=13)~     groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh~     material and patients in Group 2 will receive a regular fiberglass cast. Both groups will~     follow-up at two weeks for clinical and radiological evaluation, after which they will be~     transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast~     (Group 2) for an additional two weeks. This crossover will allow both groups to experience~     each type of cast. After four weeks of immobilization, patients in both groups will~     discontinue casting and be advised to avoid contact sports or strenuous activities until~     week 8.~      Patients in both groups will follow up 8 weeks after initial treatment for clinical and~     radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical~     function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids -~     Performance, a validated, highly reliable, self-reported measure that assesses physical~     function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain~     Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient~     satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be~     compared with initial radiographs to assess fracture displacement and angulation. Skin~     changes will be assessed at week 2 and week 4 by an independent observer blinded to the type~     of cast that has been removed and digital photographs will be obtained and analyzed using~     ImageJ Image Processing and Analysis Software to calculate the surface area of any described~     skin changes as a percentage of total skin area originally covered by the cast. Itching will~     be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of~     100 mm will be presented to the patient with no itching at the left end of the scale and~     strongest itching at the right end.~      We hope to determine whether the new, waterproof cast can result in similar clinical~     outcomes and patient satisfaction for distal radius fractures as compared with the~     traditional fiberglass cast.~   "
73548|NCT02094664|"~     The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen~     in children with bronchiolitis.~      The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will~     optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of~     breathing, and 3) decrease length of hospital stay.~   "
73516|NCT02095080|"~     Amino acid are the building blocks of the body's protein. Some amino acids, including~     leucine, cannot be made in the body and must be obtained from diet, these are called~     essential. With increase in age the body's muscle mass decrease and studies have suggested~     that dietary supplementation of leucine may have potential health benefits in elderly in~     regards to prevention of age related loss of lean muscle mass, and thus may help improve the~     quality of life in elderly.~      Currently, a safe upper dietary intake level of leucine has not been established for healthy~     elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of~     lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy~     elderly.~      The purpose of this study is to determine the tolerable upper intake level (UL) of leucine~     in healthy elderly men (70 - 75 yrs)~      The investigators hypothesize that with a careful graded stepwise increase in leucine intake~     in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's~     ability to oxidize/dispose of excess amino acids will reach a maximum. With increased~     leucine intakes we hypothesize an increase in plasma ammonia concentrations and increases in~     plasma leucine and urinary leucine excretion.~   "
73517|NCT02095067|"~     The prehospital resources are limited. The emergency medical dispatch center (EMDC) is~     manned by qualified health care personnel around the clock. The investigators believe that~     the EMDC is an unexploited resource in the prehospital treatment of patients. By the use of~     videoconferencing the investigators will activate this resource.~      Mobile videoconferencing between ambulances and physician at the EMDC enables patient~     consultation at a distance. Video consultation between patient and the physician at the EMDC~     can take place when the patient is at home or in the ambulance.~      The primary aim of this study is to examine the effect of video consultation between~     physicians at the EMDC and patients receiving treatment by ambulance personnel on the number~     of patients receiving final treatment on-site in the pre hospital setting.~   "
73518|NCT02095054|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of regorafenib and cetuximab that can be given to patients with advanced solid~     tumors. The safety and effectiveness of this drug combination will also be studied.~   "
73519|NCT02095041|"~     Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a~     measure of how much oxygen hemoglobin is carrying as a percentage of the maximum it could~     carry. Oxygen saturation can be measured non-invasively using pulse oximetry. On occasion,~     term infants are admitted to the intensive care nursery for monitoring and show variability~     in their oxygen saturation despite appearing well. As healthy newborns do not undergo~     routine monitoring of oxygen saturation, health care team do not know the degree to which~     variability in oxygen saturation are a normal phenomenon. With increasing interest in using~     pulse oximetry as a screening tool to identify at risk newborns, it is important to have a~     clear understanding of postnatal oxygen saturation trends and their variability in healthy~     babies.~      In our study, Investigators will measure oxygen saturation on healthy newborns repeatedly~     and for extended periods. This will allow us to describe both the variability in oxygen~     saturations and the pattern of changes observed in oxygen saturations over time in healthy~     newborns. To increase our confidence that babies included in our study were healthy at~     birth, they will be followed for 8 weeks to identify indicators of perinatal disease that~     was missed clinically. Any babies subsequently identified as having significant disease will~     be analyzed separately from the main cohort of healthy babies. Furthermore, the oxygen~     saturation readings will be obscured so as not to influence caregivers inappropriately.~     Lastly, pulse oximetry measurements will be performed after discharge from hospital (on day~     3 to 4), potentially increasing the clinical utility of this study as it has repeatedly been~     stated in the literature that the sensitivity of pulse oximetry to detect important~     underlying disease increases significantly if performed several days after birth. This study~     will provide important and novel normative data.~   "
73520|NCT02095028|"~     Background: Maternal obesity is associated with higher risks of adverse maternal and fetal~     complications, but the effects of dietary and lifestyle interventions on gestational weight~     gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.~      Objective: This study examined whether intensive dietary and lifestyle interventions~     initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy~     outcomes in Chinese obese pregnant women.~      Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of~     gestation.The sample size was estimated using GWG reduction as the primary outcome variable.~     The investigators pilot study (data not published) showed the gestational weight gain was~     12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in~     GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in~     intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up~     during pregnancy, the total sample size required was 136 women in intervention group and 68~     in control group(standard care group). Participants were randomly assigned to the control or~     the intervention group. The intervention focused on restricting energy intake combined with~     behavioral lifestyle modification through participation in group sessions and individual~     counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes~     were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during~     pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian~     section.~      Hypothesis:The intensive dietary and lifestyle intervention performed from the first~     trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy~     outcomes.~   "
73521|NCT02095015|"~     Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease~     caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost~     exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1~     Early identification of MPS II is challenging because some initial features, such as chronic~     runny nose, otitis media, and hernias, are commonly seen in the general population. As a~     result, even though the signs and symptoms of MPS II typically appear early in childhood,~     the diagnosis may lag behind by several years.~      The primary objective of this international multi-center study is to evaluate the positive~     screening rate of MPS II subjects by screening a high-risk male pediatric population who~     have had or are scheduled for 1 or more specific ENT surgical procedures (adenoidectomy~     and/or tonsillectomy and/or tympanostomy) and who have a previously repaired or present~     evidence of an inguinal and/or umbilical hernia.~   "
73522|NCT02095002|"~     To explore the effect of modified valsalva maneuver on the filling degree of right internal~     jugular vein.~      Method: The anteroposterior diameter and left-right diameter of right internal jugular vein~     in thirty adult gynecology patients were recorded during normal respiration and modified~     valsalva maneuver respectively.~      Investigators hypothesis that modified valsalva maneuver would enchance the filling degree~     of right internal jugular vein.~   "
73533|NCT02094859|"~     The primary purpose of this Study is evaluation of the safety and performance of the~     GlucoClear System (System).~      The primary safety objective will be assessed by:~      • Evaluation of any serious adverse device effects upon Sensor insertion through Sensor~     removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.~      The primary performance objective will be evaluated using the following criteria:~      15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197~     15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator~     values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).~   "
73534|NCT02094846|"~     The aim of the study was to assess the effect of an individualized intervention based on~     cell phones to improve glycemic control in patients with type 2 diabetes attending~     Epidemiology Research Unit in Cuernavaca, Morelos. Mexico~   "
73523|NCT02094989|"~     The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to~     detect circulation disorders and problems of the spread of the electrical heart impulse. It~     is frequently the first measure in clinical practice when angina pectoris, acute myocardial~     infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap.~      Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical~     heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are~     of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG~     recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac~     ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation~     of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate~     ECG changes to posture changes.~      Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home~     monitoring is an emerging market. Together with the superiority compared to the scalar ECG~     in detecting certain pathologies, like myocardial infarction and right ventricular~     hypertrophy, the VCG gained new interest in recent years [9]. Four ECG leads are sufficient~     to synthesize a standard 12-lead ECG from a VCG and vice versa with a transformation matrix~     [10] [11].The redirection of the spatial VCG after posture changes has been determined for~     the QRS loop with the Frank leads, which is the reference method for constructing the VCG~     [12][13].~      4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately~     in the position of three rectangular axes. Doctors are best trained to interpret standard 12~     lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three~     rectangular axes, this might allow mathematical transformation into the standard 12 lead~     ECG. A precondition would be that the transformation matrix is independent of posture. To~     date, transformation matrix between Frank VCG and standard 12 lead ECG has only been~     calculated in resting ECGs [5].~      This is the first study which investigates the transformation matrix in different postures.~     Additionally, the investigators will investigate for the first time prospectively for known~     artefacts of stress testing and ambulatory ECGs.~      Aim:~      Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in~     different postures is expected to add information on potential causes of artifacts of the~     ECG caused by posture changes. During continuous recording, the investigators will~     investigate the accuracy of the linear affine transformation with posture, the occurrence~     (dimension and duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG~     angle changes in dependence of posture changes in healthy young men.~      Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead~     VCG and standard 12-lead ECG is posture dependent.~      Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics~     improves the diagnostic accuracy of ambulatory ECG and stress testing.~   "
73524|NCT02094976|"~     Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related~     to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone~     position has been known to increase IAP. In clinical field, various apparatuses has~     developed to minimize IAP elevation during prone position operation.~      In this study, we would compare the changes of IAP and respiratory system compliance~     according to positional apparatus in prone position.~   "
73525|NCT02094963|"~     The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel~     in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.~   "
73526|NCT02094950|"~     This is a single arm clinical trial to establish the feasibility of conducting a clinical~     trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed~     chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up~     to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary~     outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at~     the completion of the intervention.~   "
73527|NCT02094937|"~     The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25~     micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low~     to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period,~     Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects~     with well controlled asthma after completing a run-in period of 4 weeks will be switched~     from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI~     100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be~     randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily~     or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will~     be a 1 week Follow-up Period following completion of the double-blind treatment period, or~     early withdrawal from the study. Overall , the total duration of subject's participation in~     the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of~     companies.~   "
73528|NCT02094924|"~     This study is required to confirm the suitability of a candidate FDC of 16mg candesartan~     cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to~     allow the design of a future pivotal bioequivalence study. This study aims to determine the~     relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg~     HCTZ relative to the reference product of same fixed dose combination (16mg candesartan~     cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised,~     single dose, two-way crossover study. Each subject will participate in two treatment periods~     and will be randomized to one of two sequences and administered one of the two treatments, A~     or B, as per the randomization schedule. The two treatment periods will be separated by a~     washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively~     eliminated from the subject between dosing occasions. The study will enroll 16 healthy~     subjects to ensure that 14 subjects complete the study as planned.~   "
73529|NCT02094911|"~     The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER~     diabetes prevention intervention in Dutch primary health care.~   "
73530|NCT02094898|"~     Study hypothesis: Do serial low-dose ketamine infusions, followed by weekly maintenance~     infusions, increase the length of time depressive symptoms stay in remission and the length~     of time associated suicide risk is improved?~      Brief Summary: This open label clinical trial is intended to further clarify initial~     response to low-dose ketamine infusion with repeated dosing and maintenance treatment model.~     Primary outcomes will be reduction in depression severity and reduction of suicide risk~     along with duration of response.~   "
73531|NCT02094885|"~     To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during~     elective vascular surgery.~   "
73532|NCT02094872|"~     This phase II trial studies how well molecularly targeted therapy works in treating patients~     with melanoma that has spread to other parts of the body. Patients must have received or do~     not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs~     or other substances to identify and attack specific types of cancer cells with less harm to~     normal cells. Molecularly targeted therapy works by treating patients with substances that~     kill cancer cells by targeting key molecules involved in cancer cell growth.~   "
73542|NCT02094742|"~     This pilot study examines the feasibility and turnaround time of performing and obtaining~     data from a few key molecular assays. These assays will be performed using different~     laboratories and technologies from core biopsies taken from patients diagnosed with invasive~     recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed~     using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated~     for ease of use to screen patients for participation in future molecularly defined clinical~     trials in breast cancer.~   "
73535|NCT02094833|"~     The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep~     B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6~     months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™)~     given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of~     age in South Korean infants that received a birth dose of Hep B and born to mothers~     documented to be serum anti-HBs Ag negative.~      Primary Objective~        -  To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus,~          poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens~          (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B,~          one month after the third dose of combined vaccines.~      Secondary Objectives:~        -  To further study the immunogenicity of the two vaccination schemes, before the first~          dose and one month after the last dose of vaccines.~        -  To study the safety after each and any dose of vaccines administered in the two~          vaccination schemes~   "
73536|NCT02094820|"~     Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition~     characterized by severe and disabling fatigue. To date much research has focused on finding~     out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result~     of this, few studies have examined the relationship between CFS and quality of life, in~     particular, more positive aspects of mental health, such as an individual's sense of~     purpose, autonomy and close relationships.~      This study will address these limitations by examining Ryff's (1989) six domains of~     psychological well-being (PWB), and other aspects of well-being including positive emotions,~     in CFS. It will also examine the relationship between measures of symptomology, emotional~     distress and PWB.~      Method: This is a cross-sectional, questionnaire-based study with a clinical sample of~     adults with CFS. Participants will complete valid measures of well-being and symptomology.~      Results: We expect to find that compared to general population norms, individuals with CFS~     score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to~     symptom measures. There are however, no grounds for making strong predictions.~      Implications: This study will advance our understanding of quality of life in CFS.~     Clinically, it has the potential to enrich and inform therapeutic interventions.~   "
73537|NCT02094807|"~     The purpose of this prospective randomized controlled study is to determine whether acute~     and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after~     surgical management as compared to conservative management.~   "
73538|NCT02094794|"~     This phase II trial studies the safety and efficacy of total marrow and lymphoid irradiation~     (TMLI) in combination with two chemotherapy drugs, etoposide and cyclophosphamide, as a~     preparative regimen before donor stem cell transplant in treating patients with high-risk~     acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have failed previous~     therapy. Intensity-modulated radiation therapy (IMRT) uses imaging to provide a~     three-dimensional view of the area to be irradiated. Doctors can then shape and direct the~     radiation beams at the area from multiple directions while avoiding, as much as possible,~     nearby organs. TMLI is a method of using IMRT to direct radiation to the bone marrow.~     Radiation therapy is given before transplant to suppress the immune system, prevent~     rejection of the transplanted cells, and wipe out any remaining cancer cells. TMLI may allow~     a greater radiation dose to be delivered to the bone marrow as a preparative regimen before~     transplant while causing fewer side effects than standard radiation therapy.~   "
73539|NCT02094781|"~     The purpose of this study was to evaluate the effect of combined whey protein and creatine~     supplement, as compared with whey protein supplement alone, on change in upper and lower~     body strength.~   "
73540|NCT02094768|"~     Much attention has been directed at the unhealthy effects of sugar-sweetened beverages~     (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In~     adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides~     compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages.~     Replacement of soda with milk had the added benefit of also reducing systolic blood~     pressure. While several studies have investigated the effects of SSBs on weight gain in~     children, no published studies have investigated their effects on lipid and lipoprotein risk~     factors under isocaloric conditions in metabolically at-risk adolescents, who are among the~     greatest consumers of SSBs. The main objective of this study is to test whether isocaloric~     replacement of soda with reduced fat milk will significantly improve atherogenic~     dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and~     obese adolescents who are habitual soda consumers. The investigators will test this in a 8~     week randomized two period crossover trial in 30 overweight and obese adolescent males who~     are self-reported habitual consumers of SSBs. Participants will consume energy equivalent~     amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk~     (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout.~     Anthropometrics, blood pressure, and blood samples will be collected at screen and at the~     end of each intervention period. Plasma measurements will include LDL peak particle~     diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and~     HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity~     C-reactive protein; uric acid; and liver enzymes.~   "
73541|NCT02094755|"~     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb~     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a~     major cause of death and disability (secondary to myocardial infarction, stroke and~     amputation). The mortality in patients with CLI approaches 25% and 50% at one and five years~     respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin~     and clopidogrel (previously referred to as resistance) is associated with an increased~     risk of recurrent cardiovascular events after percutaneous coronary interventions and acute~     coronary syndromes. The prevalence and significance of HPR in patients with critical limb~     ischemia treated with aspirin and/or clopidogrel is not known.~      The investigators project aims to investigate the prevalence of HPR (to aspirin and~     clopidogrel) in one hundred patients with diagnosis of critical limb ischemia encountered at~     University of Southern California affiliated hospitals (Los Angeles County Hospital and Keck~     Hospital of USC).~   "
73543|NCT02094729|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics,~     immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in~     subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild~     Alzheimer's disease.~   "
73549|NCT02094651|"~     The purpose of this study is to determine if treatment of epileptiform abnormalities in~     children with autism spectrum disorder will improve any behaviors in these children. The~     investigators will study a number of different behavioral outcomes including behaviors~     related to attention, social communication, repetitive behaviors, maladaptive behaviors,~     language, motor and sensory, and sleep. The investigators will use an anticonvulsant~     medication called valproic acid (in the form of sodium divalproex).~   "
73550|NCT02094638|"~     Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of~     retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection~     in the real world, observe the adverse drug reactions/ adverse drug events during treatment,~     and figure out why Tanreqing induced severe allergic reaction happens.~   "
73551|NCT02094625|"~     Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but~     causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to~     determine the dose necessary to protect hearing and also how well tolerated NAC is when~     combined with chemotherapy.~   "
73552|NCT02094612|"~     The study goal is to examine whether the use of an objective computerized neuroassessment~     (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to~     improved outcomes among pediatric patients being assessed and treated for ADHD.~   "
73553|NCT02094599|"~     The primary objective of this study is to evaluate the abuse potential of dronabinol oral~     solution in recreational cannabinoid users.~   "
73554|NCT02094586|"~     The primary goal of this Phase III study is to compare 3 lots for consistency of~     manufacture.~   "
73555|NCT02094573|"~     The purpose of this study is to evaluate the efficacy and safety of two different dosing~     regimens of AP26113 in patients with anaplastic lymphoma kinase (ALK)-positive locally~     advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on~     therapy with crizotinib.~   "
73556|NCT02094560|"~     To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate~     and rate of disease stabilization, as defined by the below primary and secondary endpoints,~     in patients with NSCLC, SCLC or biliary cancer who have progressed despite one or more~     previous chemotherapy line.~   "
73557|NCT02094547|"~     To compare the neurocognitive and immunological development in infants fed a new infant~     formula with functional specific nutrients to infants consuming a standard infant formula.~   "
73558|NCT02094534|"~     This will be a prospective, randomized, double-blind, placebo controlled study. Patients~     with established Type 1 diabetes will be eligible for entry into the study. Eligible~     patients will be screened and those who fulfill all inclusion/exclusion criteria will be~     admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening.~     Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose~     monitoring (CGM) device. Patients will be given standardized meals and snacks for the~     duration of their inpatient visit.~   "
73559|NCT02094521|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing~     conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male~     subjects.~   "
73560|NCT02094508|"~     Background:~      - Malaria is a disease that affects many children and adults in Uganda and Africa. If it is~     not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is~     a drug that is given to children born to HIV-positive mothers to help prevent infection.~     Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of~     infection in the body, which may positively impact the way the body can fight malaria~     infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps~     children fight malaria better in this way.~      Objective:~      - To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants.~      Eligibility:~      - Infants 0-6 weeks of age who are HIV negative.~      Design:~        -  Infants will be screened with a medical history and physical exam. A small amount of~          blood will be taken. The mothers medical records will be reviewed. Mothers will be~          asked about when they breastfeed.~        -  Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers~          will get a mosquito net with insecticide on it as per standard of care.~        -  Participants will come to the clinic once a month, every month, until the study ends in~          2 3 years. Each visit will repeat the screening visit.~        -  Participants will also visit the clinic every month for a medical history, physical~          exam, and different blood tests.~        -  Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the~          clinic and will either be taken off the drug or will continue taking the drug for 6~          more months.~        -  If a child becomes sick, it is important that the mother bring him or her to the RHSP~          clinic in Rakai.~   "
73561|NCT02094495|"~     The aim of this study are to to evaluate the knowledge and understanding on tamoxifen~     theraphy for breast cancer patients and examine the decision conflict scale and satisfaction~     with decision scale while making decision to take tamoxifen.~   "
73562|NCT02094482|"~     The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture~     above) in order to stiffen and stabilize the soft palate, which may reduce the severity of~     airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea).~     Indications for use of the System include: symptomatic, habitual, social snoring due to~     palatal flutter or upper airway obstruction primarily caused by the retropalatal~     obstruction. The System is labeled for use by physicians only.~      The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.~      Study hypothesis: Reduction of initial AHI ≥20%~   "
73563|NCT02094469|"~     This study will be conducted in accordance with the local regulation of New Drug~     Application. Overall duration of this trial will be 3 years after approval of MFDS.~      Each subject will participate around 26 weeks, which include the 24 weeks treatment period~     and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks~     treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn~     subjects with other reason also have 2 weeks follow up period.~   "
73580|NCT02094248|"~     The primary objectives of this study are to assess the impact of rhTPO on mortality among~     severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and~     platelet transfusion rates.~   "
75094|NCT02074410|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     OMS643762 (the study drug) in subjects with Huntington's disease (HD).~   "
73564|NCT02094456|"~     Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding~     (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may~     require hospitalization with blood transfusion and emergent intervention, with significant~     associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode~     will have subsequent episodes.~      Diverticula form at weak points along the colon wall, where the vasa recta enter the~     circular muscle layer of the colon. Diverticular bleeding is attributed to thinning of the~     blood vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively~     bleeding colonic diverticula has been recognized as a safe and effective treatment for acute~     LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude~     other causes of bleeding (e.g. angiodysplasia, colorectal cancer).~      The investigators propose prophylactic elective endoscopic diverticular clipping in patients~     who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve~     applying endoscopic clips to the base of every diverticula in a patient's colon, such that~     any bleeding source would effectively be excluded. The investigators would later reevaluate~     patients for colonoscopic appearance of diverticula to assess their diverticular disease.~      The investigators hypothesize that patients undergoing endoscopic diverticular clipping will~     not have repeat episodes of bleeding.~   "
73565|NCT02094443|"~     The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus~     (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups~     receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12~     weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously~     failed interferon therapy or were intolerant or unable to take interferon.~   "
73566|NCT02094430|"~     The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in~     pediatric patients with congenital fibrinogen deficiency.~   "
73567|NCT02094417|"~     The present study will be conducted to evaluate the efficacy and safety of AMG531 and to~     determine the recommended initial dose of AMG531 on the basis of its efficacy and safety~     when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with~     immunosuppressive-therapy refractory thrombocytopenia and also to assess the~     pharmacokinetics of this product. Its efficacy and safety during the extension period beyond~     one year will also be evaluated.~   "
73568|NCT02094404|"~     Currently, the Manchester Triage System (MTS) is used to triage all children presenting at~     the emergency department(ED) in this hospital. This system has been proven safe, but many~     patients are classified as too urgent. In this hospital adults are prioritised at the ED by~     a score based on vital signs, the early warning score. A similar score is developed suitable~     for children. This score, the Pediatric Early Warning Score (PEWS), is already used to~     determine clinical deterioration.~      The investigators hypothesize that children can be triaged safely with the PEWS.~      If it is safe, there will be one triage system again at the ED. Another advantage will be~     more continuity in assessing the condition of patients who are admitted to the hospital.~   "
73569|NCT02094391|"~     Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma~     (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the~     aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the~     progression free survival for the patients having an adjuvant treatment by Ipilimumab in~     this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So~     at least a doubling of this period would be a clinically highly significant result.~   "
73570|NCT02094378|"~     The purpose of this study is to assess the cognitive effects associated with administration~     of intranasal esketamine 84 mg.~   "
73571|NCT02094365|"~     This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo~     control in the respiratory syncytial virus challenge model.~   "
73572|NCT02094352|"~     The purpose of this study is to determine whether epidural and ketamine infusions are~     effective in the treatment of Complex Regional Pain Syndrome (CRPS).~   "
73573|NCT02094339|"~     Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may~     delay recovery. There are multimodal postoperative pain management after TKA, including~     intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular~     infiltration with local anesthetics. All of these treatments may lead to side effects such~     as nausea, headache, hypotension, urinary retention, partial motor block and infection of~     the knee. Therefore the investigators will compare three methods of postoperative analgesic~     after TKA by their efficiency and complication.~   "
73574|NCT02094326|"~     The purpose of this study is to find patterns in the use of non-biological DMARDs as the~     initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may~     impact therapeutic decisions in real life in the Spanish Andalusian region.~   "
73575|NCT02094313|"~     Recently, concerns about the effect of atorvastatin intake on men fertility have been~     raised. However, this statin has never been investigated regarding its influence on male~     fertility, notably sperm quality.~      The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of~     cholesterol blood levels, induced by taking atorvastatin, on sperm quality of~     normocholesterolaemic and healthy men without confounding factors.~   "
73576|NCT02094300|"~     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the~     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of~     patients with aortic dissection.~   "
73577|NCT02094287|"~     The study is initiated in the indication of atopic dermatitis to study the impact of placebo~     in the treatment of pruritus. Classical conditioning and expectation via~     instructions/anticipation maintain the effect of placebo.~   "
73578|NCT02094274|"~     The purpose of this study is to assess the the ability of a single dose of LAS40468~     administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®)~     administered via Accuhaler to produce bronchodilation (opening of the airways) and the~     safety and tolerability of the treatments~   "
73579|NCT02094261|"~     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in~     Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has~     Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy~     and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive~   "
73582|NCT02094222|"~     Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene.~     The disease is typically manifest in the first year of life on the basis of complications of~     cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin~     K deficiency, and/or weak bones related to vitamin D deficiency. Early management of Byler~     Disease is directed at nutritional issues which tend to be responsive to medical~     intervention, unlike the pruritus/scratching which remains a devastating problem.~     Progressive liver disease develops in Byler Disease and can lead to cirrhosis and end-stage~     liver disease. This is an open label expanded access protocol of RAVICTI in children with~     Byler Disease. The primary hypothesis is that the administration of RAVICTI in these~     children is feasible, well tolerated and safe. It is also hypothesized that RAVICTI~     treatment leads to an improvement in biochemical markers of liver disease and it may~     ameliorates or prevents the development of scratching behavior as a manifestation of~     pruritus attributed to the liver disease.~   "
73583|NCT02094209|"~     20 patients having received an AO large external fixator at the tibia will be equipped with~     a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of~     the external fixator. The device continuously measures deformation of the fixator frame due~     to weight bearing for up to 6 months by means of a strain gauge. Several parameters are~     calculated from the recorded change in the strain signal and are stored at a regular~     interval.~   "
73584|NCT02094196|"~     The aim of this project is to assess reward- based learning behavior and its association~     with alterations in dopaminergic and glutamatergic transmission in detoxified~     alcohol-dependent patients and matched controls.~      The investigators will explore how these alterations interact with clinical and psychosocial~     factors which can modify the relapse risk and learning deficits.~      Patients will be detoxified in an inpatient setting. Clinical assessments, behavioral~     paradigms of learning and brain imaging will be carried out within at least 4 half- lives~     after any psychotropic medication.~      The investigators will implement and apply functional imaging paradigms assessing~     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model~     parameters of learning with alcohol craving, intake and prospective relapse risk.~      In this project, the impact of the dopamine x glutamate interaction on learning deficits and~     consecutive relapse probability is targeted with [18F]fallypride PET and the measurement of~     absolute concentrations of glutamate with magnetic resonance spectroscopy (MRS).~   "
73585|NCT02094183|"~     Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change~   "
73586|NCT02094170|"~     The prevalence of overweight and obesity are increasing worldwide. In the U.S.,~     approximately 85,000 new cancer cases per year are related to obesity. Understanding~     lifestyle behaviors, their causes, and relations to cancer are critical. Where people spend~     their time during the day may be related to their risk of getting cancer. This project will~     assess behaviors in different locations across the day and relate exposure to different~     environments to biological outcomes.~   "
73587|NCT02094157|"~     Approximately 2 million patients in North America are currently treated with the blood~     thinner warfarin. These patients have every year more than 200,000 invasive procedures, for~     which warfarin must be stopped to avoid bleeding complication. To protect the patient~     against blood clots and stroke while warfarin is stopped, most physicians today order~     bridging with low-molecular-weight heparin (LMWH). This is another blood thinner and it is~     injected under the skin during 3 days before the procedure. For implantation of pacemaker or~     defibrillator (27,000/year in Canada) the bridging routines vary a lot.The common~     bridging treatment with LMWH for 3 days before pacemaker surgery causes bleeding in the~     pocket where the pacemaker is placed in about 5%. For comparison, patients not on any~     blood thinners develop this bleeding in 2% after this surgery. Pocket bleeding may require~     evacuation of the blood collection and may cause infection. Pocket bleeding is thus a~     fairly common and clinically important but rarely a dangerous bleeding complication. It is a~     suitable safety endpoint in a study of bridging of blood thinners. LMWH costs $80-120, for~     which some patients are not covered. They have to be taught self-injection technique or have~     a nurse come to their home. The main hypothesis is if patients on blood thinners can be~     managed more conveniently before and after pacemaker surgery, without injections, without~     increased risk of pocket bleeding.~   "
73588|NCT02094144|"~     Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting~     physical activity in postmenopausal women. Women are eligible and enrolled in the study if~     they have no significant disease affecting lower limb function and if they have a sedentary~     lifestyle. All study participants provide written informed consent to participate to the~     study.~      Women are then randomized either to the control group (women have to maintain their~     lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two~     supervised sessions and one session performed one their own per week with a detailed~     program). The intensity of the program is adapted to the heart rate work and gradually~     increases over the 6-month program. The objective of the study is to determine the health~     benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone~     density, body weight, lean and fat mass, depression symptoms, behavioral, emotional~     responses, sleep quality, and biological indicators of health.~   "
73589|NCT02094131|"~     Experimental Procedure: The subjects underwent an initial interview in which was filled in a~     form of anamnesis, in addition to being assessed and reassessed by spirometry, dynamic~     circumference and manometer. Moreover, responded international physical activity~     questionnaire (IPAQ - short version) in order to characterize the physical activity level of~     each participant being classified as inactive, irregularly active, active, and very active.~     The same examiner performed the assessments and reassessments of individuals after a~     training program.~   "
73590|NCT02094118|"~     This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced~     Red Blood Cells reduces pulmonary complications when compared to standard-of-care~     Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.~   "
73906|NCT02089984|"~     Anxiety disorders are a major public health concern, having a profound impact on~     functioning, causing significant disability, loss of productivity and suffering. Effective~     treatments exist for these disorders, but few clinicians are trained in these methods. This~     project attempts to remedy this shortcoming by using web-based tools to facilitate access to~     this training, thus increasing the number of available therapists in order to help meet this~     unmet need.~   "
73591|NCT02094105|"~     Importance: There are no global screening recommendations for esophageal squamous cell~     carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of~     China since 1970's. But up until now there no apparent evidence that would lead to a~     reduction in disease morbidity and mortality.~      Objective: To evaluate whether endoscopic screening and early intervention program could~     reduce the incidence or mortality of ESCC.~      Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening~     was completed from November 1999 to May of 2000. Subjects in intervention group were~     examined once during intervention period. The study follow-up concluded in December 2009.~      Setting: High risk area of ESCC in China~      Participants:Cluster sampling from communities with high rates of esophageal cancer. A set~     of villages with was selected as the study intervention community. Age 40 to 69 years~     residents were selected as an eligible population. Another set of villages was select as the~     control population. Buffer villages were set up between intervention and control group.~      Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous~     lesions was undergone for the intervention group.~      Main Outcome(s) and Measure(s): Incidence and mortality ESCC~   "
73592|NCT02094092|"~     This study will work on hypothetical assumption that compared to the arm supplemented with~     placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing~     time per 24 hours at one month post randomization. And that the L reuteri (intervention)~     group at 7, 14, 21, days and 1 week after the therapy cessation will have:~        -  Lower crying/fussing time per 24 hours.~        -  Relief from colic pain~        -  Longer sleep duration,~        -  Higher scores on a standardized measure of maternal mental health~   "
73593|NCT02094079|"~     The aim of the study was to evaluate the clinical control program in patients with~     hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by~     monitoring the patients every 4. week during pregnancy to keep the thyroid function~     parameters within the recommended range?~      A retrospective study of consecutive pregnant women with hypothyroidism followed at the~     outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients~     selected through electronic medical system. Blood tests for the The hormone levels drawn~     from the laboratory of Clinical Biochemical Department, Herlev Hospital~   "
73594|NCT02094066|"~     The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood~     transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.~   "
73595|NCT02094053|"~     The purpose of this double-blind, placebo-controlled, comparative study and open-label~     extension study is to confirm the efficacy and safety of E2020 in subjects with Down~     syndrome having regression symptoms and disabled activities of daily living.~   "
73596|NCT02094040|"~     The purpose of this study is to determine whether discharge follow-up visit by primary~     physician and community-based nurse affects the risk of early re-hospitalisation among high~     risk older people discharged from a medical ward.~   "
73597|NCT02094027|"~     To demonstrate the effectiveness of an easily administered intervention (guided self help)~     aimed at reducing binge eating in patients undergoing bariatric surgery.~      The investigators hypothesize that patients who have guided self help pre-operatively will~     have reduced episodes of bingeing pre-operatively compared to those having treatment as~     usual (bariatric surgery), which will be maintained in the post-operative period, and will~     be associated with improved weight loss and psychological outcomes after surgery.~   "
73598|NCT02094014|"~     Impaired speech production is a major obstacle to full participation in life roles by stroke~     survivors with aphasia and apraxia of speech. The proposed study will demonstrate the~     short-term effects of auditory masking on speech disfluencies and identify individual~     factors that predict a positive response, enabling future work to develop auditory masking~     as a treatment adjuvant targeting long-term improvement in speech. Providing an additional~     treatment option for adults with aphasia and apraxia of speech will have the clear benefit~     of improving quality of life and allowing individuals to participate more actively in their~     health care decisions through improved communication.~   "
73599|NCT02094001|"~     Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the~     pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive~     pulmonary hypertension (PH) and right ventricular failure- most common cause of death for~     patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved~     in Canada for the treatment of CTEPH.~      This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will~     show changes in glucose metabolism and improved resting myocardial blood flow using positron~     emission tomography ( PET ) imaging to measure myocardial function. The response between~     both treatment naive patients as well as patients on maximally tolerated dose of riociguat~     with tratment duration of at least 3 months will be included.~   "
73600|NCT02093988|"~     Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in~     spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood~     loss. When used intravenously, it has been shown to safe, efficacious, and effective in~     reducing transfusion requirements and blood loss in spine surgeries. We want to evaluate the~     effect of using TXA topically and intravenously to see if it further reduces blood loss in~     children undergoing major surgery compared to IV TXA only~   "
73601|NCT02093975|"~     Physician manned rapid response vehicles are a limited resource in the prehospital handling~     of acute patients.~      In this study mobile videoconferencing between ambulances and the rapid response vehicles~     enables patient consultation at a distance. Video consultation between patient and the~     prehospital physician can take place when the patient is at home or in the ambulance.~      The primary aim of this study is to examine the effect of video consultation between~     physician manned rapid response vehicles and patients receiving treatment by ambulance~     personnel on the number of patients receiving final treatment on-site in the pre-hospital~     setting~   "
73602|NCT02093962|"~     The purpose of this study is to determine whether TH-302 in combination with pemetrexed is~     safe and effective in the treatment of non-squamous non-small cell lung cancer.~   "
73603|NCT02093949|"~     To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection~     with a multipolar catheter (Pentaray) and the  SCI 30-40  setting of CARTO CFAE algorithm.~   "
73907|NCT02089971|"~     To describe the normal range of muscle mass and function in Chinese adults.~   "
73604|NCT02093936|"~     Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway~     inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive~     pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values~     and cut-off points for this technique based on cellular components of IS, such as~     percentages of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell~     lymphocytes. However, normal values and cut-off points for lymphocyte percentages indicative~     of pathology have not yet been established or validated. This component of IS has~     considerable clinical value. Similar to other constituents of IS, it can provide biological~     insights into the pathogenesis of respiratory disorders and contribute to establishing the~     diagnosis and guiding treatment management of a variety of airway diseases.~      The purposes of this study are to define normal values and cut-off points of lymphocytes in~     IS among individuals with respiratory disorders and healthy volunteers, and to verify the~     current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in~     IS.~      Methods: A Cross Sectional study which includes a database on up to 900 patients who~     participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky~     Medical Center between 2005 to 2012 will be established. The study population will include~     patients diagnosed as having various pulmonary diseases and a group of healthy volunteers~     who will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and~     neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and~     evaluating sensitivity and specificity. The comparison of the different values to those in~     the literature will be done by using the Spearman rank correlation.~      The results of this study will provide supplementary information on lymphocyte counts in IS~     for identifying and treating various respiratory diseases.~   "
73605|NCT02093923|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic~     profile of multiple subcutaneous administrations of DX-2930 across a range of doses in~     Hereditary Angioedema subjects.~   "
73606|NCT02093910|"~     Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral~     neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs~     within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no~     effective prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a~     nerve-protecting drug,was often used to promote growth of nerve, and function restoration of~     damaged nerve.Thus,the investigators hypothesized that combination of~     Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral~     neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma~     (MM) patients.~   "
73607|NCT02093897|"~     This is an international, multicenter, open-label study to assess the efficacy, safety, and~     pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe~     hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at~     least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a~     previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned~     to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain~     at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the~     subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.~   "
73608|NCT02093884|"~     The objective of this study is to develop and test an emergency department (ED)-based~     intervention which uses text messages to facilitate contraception initiation.~   "
73609|NCT02093871|"~     To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided~     every 28 days in 3rd line ovarian cancer patients.~   "
73610|NCT02093858|"~     Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role~     in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with~     metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and~     SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in~     the development of antipsychotics-induced metabolic syndrome.~   "
73611|NCT02093845|"~     The purpose of this study is to perform a randomised comparison between the SYNERGY and the~     Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.~   "
73612|NCT02093832|"~     This study had four aims:~        1. To evaluate the correlation between the planned preoperative cup size and the actual~          cup size that was implanted in surgery.~        2. To examine the absolute difference between the implanted cup size diameter and the~          actual femoral head size diameter.~        3. To examine the absolute difference between the planned cup size diameter and the actual~          femoral head size diameter~        4. To suggest an additional online monitoring tool on the accuracy of the preoperative~          process and implant selection. We hypothesized that high accuracy rates will be found~          between the preoperative planned cup size and the actual implanted cup size.~          Furthermore, we hypothesized that strong correlations will be found between the planned~          and actual implanted cup size and the actual femoral head diameter size.~   "
73613|NCT02093819|"~     To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics~     (PK) of single rising doses of BI 416970. A further objective is to assess the influence of~     CYP2C9 phenotype on the PK of BI 416970.~   "
73614|NCT02093806|"~     The purpose of this study is to measure the size of the round window niche and its relation~     to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution~     computerized tomography of the temporal bone, in order to assess preoperatively what is the~     extent of obstruction of the round window membrane and whether there is a surgical~     possibility of round window approach in the insertion of electrode array into the cochlea~   "
73615|NCT02093793|"~     To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator System~     Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic~     intractable pain~   "
73616|NCT02093780|"~     In the present study, ulcerative colitis (UC) patients in the remission stage of the disease~     will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide~     diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a~     role in decreasing the risk of UC development or management of UC-related symptoms or~     relapse. Since the primary outcome of interest is the relapse rate in two groups, disease~     status will be assessed monthly using appropriate tools. In order to find out the underlying~     mechanisms that will relate the proposed diet to decreased flare rate, some laboratory~     evaluations, which are mainly markers of inflammation or are related to gut microbiome will~     be conducted. In the present study, the investigators will also perform state-of-the art~     metabolomics tests, in order to study how the dietary changes will change the end~     metabolites. In addition, the investigators will be able to explore if metabolomic profile~     of participants can predict future UC relapse. This study will last for 6 months from~     baseline wherein all the study subjects will receive appropriate dietary instructions in~     addition to their stable doses of maintenance drug therapy.~   "
73617|NCT02093767|"~     Based on the efficacy of inulin and oligofructose in treating experimental colitis and~     emerging evidence suggesting probiotics are efficacious in maintaining and inducing~     remission in human ulcerative colitis (UC), the investigators intend to conduct an open~     label study using Synergy-1, a 1:1 oligosaccharide/ inulin mixture, in patients with mild to~     moderately active left-sided UC. The investigators hypothesize that oligofructose-enriched~     inulin (Synergy-1) can be used safely in the treatment of mild to moderate UC, and daily~     oral administration of Synergy-1 will result in the clinical improvement and/ or remission~     of disease. Subjects will be randomized to either a 7.5g or 15g dose of Synergy-1 in order~     to investigate what amount of the prebiotic is efficacious and tolerable in patients with~     active UC. The clinical activity of disease will be evaluated using endoscopy and symptom~     scores. The investigators will also study the effect Synergy-1 on mucosal histology,~     intestinal microbiota composition and function and markers of inflammation (e.g. fecal~     calprotectin, cytokines). The study will be for 9 weeks from baseline wherein all subjects~     will receive Synergy-1 treatment. Half the subjects will receive a dose of 7.5g and half~     will receive 15g daily.~   "
73618|NCT02093754|"~     This study will allow to assess liver related injuries in HIV patients.~   "
73619|NCT02093741|"~     This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on~     the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection~     (SWFI) during routine clinical practice in children until 12 years of age. This surveillance~     study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.~   "
73620|NCT02093728|"~     Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of~     Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers~   "
73621|NCT02093715|"~     The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and~     blood cytokines during acute bronchiolitis, and to seek for correlation between these~     markers and future development of asthma.~   "
73622|NCT02093702|"~     The objective of this study is to assess whether a structured exercise program compared to~     routine recommendation for exercise has any positive impact on disease outcome in patients~     with type 2 diabetes.~      This study aims to assess whether a structured exercise program has an impact on the~     following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids,~     body mass index and waist circumference. It also aims to assess the compliance and retention~     of patients with type 2 diabetes in a structured exercise program.~   "
73623|NCT02093689|"~     The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative~     Floppy Iris Syndrome in patients at risk.~   "
73624|NCT02093676|"~     It is presumed that families of poorly controlled diabetic adolescents (type 1) would~     benefit from parents' counselling, guided by the New Authority model.~   "
73625|NCT02093663|"~     To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in~     children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or~     who are in remission.~   "
73626|NCT02093650|"~     Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate~     to severe menopausal symptoms~   "
73627|NCT02093637|"~     The purpose of this study is to determine if the addition of Battlefield Auricular~     Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to~     ambulation without assistance, hours missed from work and increases quality of life after~     lower extremity surgery at two Air Force Medical Centers.~   "
73628|NCT02093611|"~     We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance~     motor unit recruitment while simultaneously blunting the decline in power and reaction time~     that is typically seen during repetitive sprints. This will give researchers a better~     understanding of the mechanism by which ATP supplementation can augment power, especially~     under high fatiguing conditions.~   "
73629|NCT02093598|"~     Type of Application: Clinical trial of new indication.~      Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously,~     infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).~     Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).~     Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09.~      Primary Objective:~        -  To identify in tumor samples future biomarkers associated with a short term exposure to~          temsirolimus.~        -  This is an exploratory clinical study. No efficacy objectives are included in this~          clinical trial.~      Secondary Objectives:~        -  To estimate the tolerability for all temsirolimus-treated patients throughout the study~          and up to 28 days after the last dose of temsirolimus.~        -  To correlate observed changes with the different type of endometrial carcinoma (type I~          and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D,~          p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR),~        -  To estimate the potential predictive value of some biomarkers (immunostaining for PTEN,~          pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite~          instability status.~        -  To estimate the prognostic value of Ki67 expression after short-term presurgical~          therapy exposure~        -  To collect data about the differences in expression profile, assessed by RNA~          microarrays~   "
73630|NCT02093585|"~     Some but not all observational studies have found that current exposure to abacavir is~     associated with increased risk of cardiovascular events such as myocardial infarction,~     stroke and cardiovascular death. This study aim to investigate possible adverse effect of~     abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected~     patients. The study is an open-labeled cross-over trial, where patients receiving~     antiretroviral therapy containing abacavir switch treatment to a regimen containing~     tenofovir and vice versa for a period of 90 days.~   "
73631|NCT02093572|"~     The purpose of this study is to test the hypothesis that the disruption of the normal~     (three meals a day) eating pattern and prolonged overnight fasting caused by skipping~     breakfast: i) alters the expression of specific clock genes and clock gene targets involved~     in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal~     adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA)~     concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong~     plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying~     healthy, lean persons either randomized to consume either 3 standard meals per day or omit~     breakfast and consume 2 meals per day without changing daily calorie intake (skipping~     breakfast group).~   "
73632|NCT02093559|"~     REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose~     and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose~     education curriculum within an Informational-Motivation-Behavior (IMB) model. This study~     will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information~     and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation,~     and overdose and HIV risk behaviors, among opioid-dependent persons who have previously~     overdosed and already received take-home naloxone (the opioid antagonist used to reverse~     overdose).~   "
73633|NCT02093546|"~     The goal of this study is to check the effect of trametinib alone and when given with~     GSK2141795 on biomarkers in patients with persistent or recurrent endometrial cancer.~     Biomarkers are found in the blood/tissue and may be related to your reaction or response to~     the study drug.~   "
73634|NCT02093533|"~     Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end~     stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative~     complement pathway and familial forms for all types of MPGN have been reported suggesting~     that genetic abnormalities may play a predisposing role to the disease. In recent case~     reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the~     membrane attack complex ,is a safe and effective therapy.~   "
73635|NCT02093520|"~     Study Objective: To compare patient outcomes following treatment with either the MILD~     procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal~     stenosis exhibiting neurogenic claudication and having verified ligamentum flavum~     hypertrophy as a contributing factor.~   "
73636|NCT02093507|"~     The purpose of this study is to determine whether the result of parent's feet manipulation~     compared with nonmanipulated group within first 6 months of life and observe spectrum of the~     disease within this period.~   "
73637|NCT02093494|"~     This is a randomized, open label study to evaluate the Initial Specimen Diversion Device~     (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will~     be derived from inpatient and/or outpatient settings in a variety of hospital departments~     (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be~     included in this study. The ISDD will be compared to current laboratory practices for the~     collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as~     collection of venipuncture blood for culture without an initial diversion method to divert~     and sequester potential blood contaminants.~   "
73638|NCT02093481|"~     The experimental model is a semi-acute study where the purpose of the study is to evaluate~     food factors related to colonially derived regulation of glucose metabolism (and related~     parameters) and satiety in healthy subjects.~   "
73639|NCT02093468|"~     The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects~     receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether~     treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid~     tissue perfusion in the effected blood vessel.~   "
73640|NCT02093455|"~     This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill~     form) with the purpose to test the impact of a four-month supplementation with Chardonnay~     Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and~     seeds. We will examine the effect of CSF on parameters such as endothelial function (via~     EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory~     markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the~     makeup of and impact on the gut microbiome (via stool samples).~   "
73641|NCT02093442|"~     Endometrial injury performed in a cycle preceding the one for embryo transfer is associated~     with an increased implantation and pregnancy rate when carried out during the month~     preceding that of ovulation induction and fresh embryo transfer. However, there is no~     evidence about the effect of this intervention on the transfer of cryopreserved embryos.~   "
73642|NCT02093429|"~     The study design includes a 3-dose randomization phase to determine effective doses of~     INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to~     respond to erythropoiesis-stimulating agents (ESAs) followed by an extension phase.~   "
73643|NCT02093416|"~     Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical~     population compared with non obese controls. Additionally serum levels of leptin, ghrelin,~     motilin and PYY will be compared amongst the different BMI classes and a quality of life~     questionnaire completed by all participants.~      The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is~     partially responsible for the higher serum leptin levels without appropriate control of~     satiety.~   "
73644|NCT02093403|"~     This phase I trial studies the side effects and best dose of Selinexor when given together~     with decitabine in treating patients with acute myeloid leukemia that has returned after~     treatment (relapsed) or does not respond to treatment (refractory). Drugs used in~     chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing.~   "
73645|NCT02093390|"~     This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the~     effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics~     of TAK-385 in healthy adult subjects.~   "
73646|NCT02093377|"~     The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive~     Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial~     infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).~   "
73647|NCT02093364|"~     The purpose of this focused registry is to evaluate the clinical implications of the RHP~     position (relative to the articulations) regarding functional and radiographic parameters in~     patients treated with the RHP with a straight and curved stem.~   "
73648|NCT02093351|"~     This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A~     of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of~     anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if~     eligible) continued access to olaparib after the PK phase and will provide additional safety~     data.~   "
73649|NCT02093338|"~     The main objective of this intervention study is to evaluate the efficacy of Lactobacillus~     fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and~     Streptococcus as risk factors for mastitis in women with breast pain~   "
73652|NCT02093299|"~     Stroke patients are given prophylactic treatment with clopidogrel to prevent new strokes.~     Some of these patients (the investigators don't know precisely how many, but previous~     studies indicate 4-34%) are so called non-responders, when you measure on a blood sample~     from the patient. These patients may have an increased risk for less effect of the treatment~     and therefore a higher risk for a new stroke.~      The investigators want to investigate if clopidogrel non-responders have a clinically~     increased risk of a new stroke by following the patients for two years. With this study the~     investigators aim to ensure that all patients get the best prophylactic treatment and reduce~     the risk of early death and dependency of others.~   "
73653|NCT02093286|"~     To assess any serious systemic reaction within 30 minutes after Pentabio immunization~   "
73654|NCT02093273|"~     The objective of this study is to compare the antibody response 30 days after two doses of t~     OPV~   "
73655|NCT02093260|"~     To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and~     Children (Bridging Study)~   "
73656|NCT02093247|"~     This study is Observational multi-center, prospective study to characterize novel pathogen-~     and host-related factors in hospitalized patients and patients in the Emergency Department~     (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's~     objective is to develop a novel multi-parametric diagnostic model for the management of~     patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related~     factors.~   "
73657|NCT02093234|"~     This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors~     and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell~     phone disease management system plus a community health worker (CHW) is superior to either a~     cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of~     7 Wellness Behaviors and 6 Clinical Goals.~   "
73658|NCT02093221|"~     This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of~     human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years~     old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM).~     Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed~     enrollment will be opened to the child cohort. The purpose of this study is to evaluate the~     safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.~   "
73659|NCT02093195|"~     Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in~     reducing COPD exacerbation and hospitalization, improving the life quality, and postponing~     the lung function decline. But for some patients with severe COPD, current treatment only~     partially alleviates the symptoms and has little role in the lung function decline. In this~     randomized, multicenter study, the investigators evaluate the safety and efficacy of~     bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected~     by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the~     secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ~     score and mMRC/CAT score.~   "
73660|NCT02093182|"~     The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic~     brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance~     Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized~     to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy,~     highly operator dependent and more.~      HS-1000 device, an investigational vasospasm detection device, has the potential to safely~     diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality~     for vasospasm measurement tool.~      We aim to evaluate the correlation between the collected and analyzed data from the HS-1000~     device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH)~     patients.~   "
73661|NCT02093169|"~     To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma~     concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu~     AF35700~   "
73662|NCT02093156|"~     Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate~     bowel preparation is essential for optimal visualization of the colorectal mucosa. However,~     inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients~     undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which~     can be broadly categorized as patient-related or procedure-related. It has been shown that~     split-dose regimen or some modified educational strategies can improve the quality of bowel~     preparation. For the patients with possible IBP before the performing of colonoscopy, it may~     be better to repeat bowel preparation with modified or enhanced strategies in case of failed~     intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up~     a model to predict the quality of bowel preparation individually.~   "
73663|NCT02093143|"~     The most important considerations for the general anesthesia in diagnostic panendoscopy of~     the upper airway is the maintenance of a patient's airway for optimal surgical exposure,~     adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques~     with preserved spontaneous ventilation and total intravenous administration of anesthetic~     drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often~     considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous~     studies suggested that adding remifentanil to propofol could improve the conditions for~     laryngoscopy and tracheal intubation.~      The aim of this study is to assess the impact of propofol remifentanil general anesthesia~     compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of~     the upper airway.~   "
73673|NCT02093013|"~     The investigators propose to implement and evaluate an integrated care program for enhancing~     the care of patients with asthma in a region of Quebec province, Canada. The investigators~     will implement our intervention in a family medicine group practice setting and plan to~     deliver it to 150 experimental group subjects. The investigators will simultaneously study~     300 control subjects who are receiving usual care in other regions of the province of~     Quebec. Our hypothesis is that the program will improve the quality of life of patients with~     asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge~     of asthma, and a number of variables that relate to the conceptual model selected as a~     framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).~   "
73664|NCT02093130|"~     This project is designed to study whether pomegranate juice benefits cognitive abilities in~     middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of~     two treatment groups: either a placebo or the pomegranate juice. Subjects will drink eight~     ounces of the pomegranate juice or placebo daily for twelve months.~      The investigators expect the people receiving the pomegranate juice to show better cognitive~     performance compared with those receiving a placebo after one, six, and twelve months. The~     investigators believe cognitive decline and treatment response will vary according to a~     genetic risk for Alzheimer's.~      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects~     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to~     rule out other neurodegenerative disorders linked to memory complaints.~      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.~     Following the first assessment, subjects will begin drinking the juice (either the~     pomegranate juice or the placebo). Subjects will undergo a brief memory test at one-month~     mark. At six months, subjects will have a second, full neuropsychological assessment. The~     final assessment will take place at the end of the study, the 12-month mark. Additional~     blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers~     if outcomes are positive.~      In total, subjects will be expected to come to the University of California, Los Angeles~     (UCLA) for 5 visits during the course of 12-13 months.~   "
73665|NCT02093117|"~     Background. Patients undergoing neurosurgical procedures experience higher rates of~     postoperative respiratory failure compared to the broader surgical population.~     Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be~     beneficial. Despite this potential benefit, the effect of high levels of continuous airway~     pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined~     prior to applying this intervention to the neurosurgical population.~      Objectives. The primary objective is to determine the effect of an alveolar recruitment~     maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The~     secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1)~     brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial~     tumour resection.~      Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of~     water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in~     subdural pressure.~      Methods. This single center, randomized, cross-over study will enroll 30 American Society of~     Anesthesiogists Classification I-III patients scheduled to undergo supratentorial brain~     tumour resection at Vancouver General Hospital. All patients will receive a standardized~     general anesthetic including invasive blood pressure monitoring. After removal of the bone~     flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain~     bulk will be assessed using a validated 4-point scale. After baseline arterial and subdural~     pressure determination and brain swelling assessments, patients will be randomized to~     receive either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment~     maneuver of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum MAP during~     the maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk.~     After a 2-minute equilibration period, the protocol will be repeated with the alternate~     group allocation.~      Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural~     pressure), determined that a sample size of 22 patients would allow us to detect a~     difference of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error~     of 0.2 and two-sided significance testing. The subdural pressure during the recruitment~     maneuver as compared to the sham maneuver will be analyzed using a paired t-test. The brain~     bulk score will be compared using a Wilcoxon signed rank test. All data analysis will be~     performed with STATA 12.1 (StataCorp, College Station, TX).~   "
73666|NCT02093104|"~     The purpose of this research study is to evaluate the quantitative information of utilizing~     C-arm systems in liver tumor care in hopes this potential clinical combination of imaging~     could aid in diagnosis and evaluation of tumor therapy.~   "
73667|NCT02093091|"~     This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer~     (RMGI) -with a brand name of Ketac Nano- as a filling material for the treatment of caries~     in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano~     or another conventional RMGI called Vitremer. Then, the treated children were evaluated at~     baseline, after one yeat and after two years. The hypothesis to be tested in the present~     study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary~     molars will differ from that of its preceding conventional RMGI (Vitremer).~   "
73668|NCT02093078|"~     Crisis resource management represents the set of non technical skills, such as~     communication, leadership, delegation, and prioritization, that allow effective teamwork for~     optimal patient care during an urgent and critical situation. The Cognitive Aids with Roles~     Defined (CARD) is a new concept of cognitive aid addressing the well-documented issue of~     teamwork in crisis management. It relies on large identification cards specially designed~     for each team members profession and role. During a life threatening clinical situation, the~     CARD protocol focuses on clarification of individual roles and distribution of tasks for~     crisis management rather than creating an additional algorithm identifying either a list of~     actions to be taken or the dose of a medication. This study aims to evaluate the clinical~     impact of introducing the CARD protocol in obstetrical emergency situations (code 333) in~     clinical practice at The Ottawa Hospital.~      Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and~     (ii) improve clinical outcome for the mother and baby compared to traditional management~     without the CARD protocol.~   "
73669|NCT02093065|"~     Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked~     recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are~     classified into 3 different categories based on residual FVIII activity compared to normal:~     mild (6-40%), moderate (1-5%) and severe (<1%). This categorization correlates to some~     degree with bleeding phenotype, but does not completely define it. Some patients with~     hemophilia A bleed less often than others despite identical plasma FVIII levels. The~     cause(s) of this phenotype heterogeneity in hemophilia A remains largely unknown, despite a~     number of studies of possible factors.~      Activated platelets, in addition to their role in primary hemostasis, play a major role in~     secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation~     factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been~     suggested in the past, but only a small number of studies have been performed with~     limitations in assays performed and numbers of patients. The purpose of the present study is~     to determine whether platelet reactivity in severe hemophilia A patients is associated with~     past bleeding frequency and/or predicts future bleeding frequency.~   "
73670|NCT02093052|"~     This study will assess early and middle childhood outcomes of an intervention for neglecting~     parents that was implemented in the children's infancy. We expect that parents who received~     the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and~     will follow children's lead more than parents who received a control intervention, and that~     children will show better outcomes in attachment, inhibitory control, emotion regulation,~     and peer relations than children of parents who received the control intervention.~   "
73671|NCT02093039|"~     The aim of this study is to assess the impact of a decision aid leaflet on the participation~     of women invited to participate in the French national breast cancer screening program.~   "
73675|NCT02092987|"~     The primary research question is which of the 2 best known dementia caregiver interventions,~     the New York University Caregiver intervention (NYUCI) and Resources for Enhancing~     Caregivers Health (REACH OUT), is more effective in alleviating depressive symptoms and~     caregiver burden among Hispanic caregivers in New York City. The investigators hypothesize~     that the NYUCI will be more effective than REACH OUT in reducing caregiver depressive~     symptoms and burden among Hispanics because of its focus on family-centered counseling,~     which is posited to be more important among Hispanic caregivers because of a cultural~     emphasis among Hispanics on family interactions in interventions. In order to answer the~     primary question, the investigators will conduct a pragmatic randomized trial comparing the~     NYUCI vs. REACH OUT in 200 Hispanic caregivers of persons with dementia in the community of~     Northern Manhattan. The total time of the intervention will be 6 months.~      Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic~     relative (any relative) caregivers of persons with dementia. Our objective is to obtain~     effectiveness information that will help caregivers and health providers to make decisions~     about which intervention to choose. Our primary aim is to compare the effectiveness of the~     implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our~     exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and~     REACH OUT and to examine additional outcomes such as caregiver stress and physical health,~     and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic~     randomized trial of 200 relative caregivers of persons with dementia. Participants will be~     randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6~     months, with assessments at baseline and follow-up. All interventions and questionnaires~     will be conducted in both English and Spanish. The study duration will be 3 years. The~     primary outcomes will be changes in caregiver depressive symptoms, measured with the~     Geriatric Depression Scale, and in caregiver burden using the Zarit caregiver burden~     interview.~   "
73676|NCT02092974|"~     The aim of this study is to assess whether the application of a selective serotonin reuptake~     inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal~     transcranial direct current stimulation (atDCS). For this, young and older healthy subjects~     will be tested with a well established learning paradigm. Results of this study may help to~     support the application of atDCS also in patients, e.g. with dementia or mild cognitive~     impairment.~   "
73677|NCT02092961|"~     This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative~     and more sensitive modalities for measuring the beneficial effects of syk inhibition with~     fostamatinib in patients with active RA. This MRI sub-study was reported later than the main~     study due to recruitment delays at specialist imaging sites and so is registered and~     presented entirely separately to the main study results.~      This study will investigate the impact of treatment on joint activity and damage by~     assessing synovitis, osteitis, bone erosions and joint space narrowing.~   "
73678|NCT02092948|"~     The purpose of the study is to determine whether positron emission tomography (PET), using~     the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or~     bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs,~     etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate~     Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder~     cancers.~   "
73679|NCT02092935|"~     The purpose of this research study is to evaluate the safety and effectiveness of a new oral~     antibiotic called SMT19969 in treating C. difficile Infection (CDI).~   "
73680|NCT02092922|"~     The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma~     will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be~     followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160~     patients from North America and Europe will be enrolled in this study.~      Eligible patients will have received at least two prior lines of therapy; have received~     prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or~     pomalidomide.~   "
73681|NCT02092909|"~     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in~     approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key~     linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and~     IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The~     scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's~     macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway,~     thereby interrupting the proliferation of cell populations responsible for the propagation~     of the disease.~   "
73682|NCT02092896|"~     The purpose of this study is to:~      Part 1:~      To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly~     controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.~      Part 2:~      To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects~     counterregulatory hormones and cognitive performance during hypoglycemia.~   "
73683|NCT02092883|"~     The purpose of this study was to investigate the presence of neuroinflammation in children~     with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its~     response to ACTH treatment by repeating the PK PET scan after treatment.~   "
73684|NCT02092870|"~     Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic~     wounds.~   "
73685|NCT02092857|"~     The immune system of newborn infants is immature with low activity of both innate and~     acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary~     fatty acids are one nutritional factor noted to play a role in immune function. The omega-6~     long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid,~     DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The~     balance or relative amounts of ARA and DHA have been associated with immune response. Some~     commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and~     DHA has not been determined with respect to immune function. This study will assess two~     levels of ARA and the impact on immune response in healthy, term infants and whether genes~     that influence essential fatty acid metabolism alter the nutritional requirement of infants.~   "
73686|NCT02092844|"~     The primary aim of the current study is to evaluate the effectiveness of a Cognitive~     Behavioral Therapy intervention in the treatment of menopause-associated insomnia and~     nocturnal hot flashes.~   "
73687|NCT02092831|"~     This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the~     relative bioavailability of GDC-0941 administered as a single dose of the market image~     formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the~     Phase 2 formulation to healthy male and female volunteers. Participants will be randomly~     assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation),~     and GDC-0941 will be administered based on the assigned sequence. The study is expected to~     last 8 weeks.~   "
73688|NCT02092818|"~     In accordance with the regulatory guidance this registry has been designed to collect~     information about the long-term safety of Adempas in real clinical practice outside the~     regulated environment of a controlled clinical study.~   "
73689|NCT02092805|"~     The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in~     patients suffering from malignant visceral pain. Thirty four patients were included in the~     study. They are divided randomly into 2 groups using closed envelop as real rTMS group and~     sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train~     interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for~     ten consecutive days (5 days/week) and the coil elevated and angled away from the head as~     sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog~     scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st,~     5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn)~     level was measured at baseline, 5th and 10th session.~   "
73690|NCT02092792|"~     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and~     PK of escalating doses of DLYE5953A administered to patients with incurable, locally~     advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase~     I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected~     patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety,~     tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled~     to further characterize the safety, tolerability, and PK of the proposed dose and schedule~     for future studies.~   "
73691|NCT02092779|"~     Obesity is a disease not always attributable to nutritional imbalance, frequently associated~     with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after~     hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to~     explore pituitary morphology and its association with pituitary function and metabolic~     phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the~     Department of Experimental Medicine of the University of Rome La Sapienza, with features of~     HP disease in a cross-sectional .~   "
73692|NCT02092766|"~     Delayed anaemia has been reported in European travellers with malaria cured by artesunate.~     Although no deaths related to this delayed anaemia have been reported so far, blood~     transfusion has been necessary in some affected patients. Recent observations suggest that~     this episodes of anaemia also occurs in endemic countries. The aim of this trial is to~     assess the incidence of late onset anaemia after treatment with intravenous artesunate~     compared to intravenous quinine, to identify patients at risk and to clarify the causes of~     this delayed anaemia.~   "
73693|NCT02092753|"~     The aim of the study is to analyze if a ketogenic diet (KD) compared to either a low~     glycämic and insulinemic (LOGI) diet or to a standard diet (SD) is feasible, safe and~     tolerable and will improve quality of life and physical performance in patients with Breast~     Cancer during the rehabilitation phase.~      It will be an open-label trial of nutritional intervention for 20 weeks spanning three~     phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of~     stationary intervention.~   "
73694|NCT02092740|"~     Retrospective analysis of treatment outcome and side effects of testicular cancer patients~     that had been diagnosed at the University Magdeburg from 1960 until 2012.~   "
73695|NCT02092727|"~     The Southeastern Kidney Transplant Coalition is an academic-community collaboration between~     partners in the kidney disease community who share the common goal of eliminating health~     disparities in access to kidney transplantation among African American End Stage Renal~     Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this~     community-based coalition include patients with kidney disease, dialysis facility staff and~     providers, transplant centers, quality improvement organizations, and patient advocacy~     organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of~     kidney transplantation is the lowest in the nation. Further, the investigators research~     suggests that racial disparities in access to kidney transplantation are concentrated in the~     Southeast, where African Americans are less likely to access each step in the transplant~     process. The long-term goal of the investigators Coalition is to use community- based~     participatory research approaches to develop, test, and disseminate sustainable, community~     interventions improve access to transplant for African American patients with kidney~     disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community~     study proposes to use community-based participatory research methods to develop a multilevel~     intervention to reduce racial disparities in access to kidney transplantation. The long-term~     impact of this application will be to reduce racial disparities in the kidney disease~     community.~   "
73696|NCT02092714|"~     This pilot research trial studies molecular analysis in tissue samples from patients with~     advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with~     neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and~     plan the best treatment.~   "
73697|NCT02092701|"~     Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may~     experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D~     supplementation during one year can improve bone and muscle health in post-burn period.~   "
73698|NCT02092688|"~     This is a prospective observational trial that will enroll pregnant women between 24 and 36~     6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically~     intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women~     without signs and risks for PTL to assess how the results of the novel kit for the detection~     of PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse~     neonatal and pregnancy outcomes.~      Thes study hypothesis contains that the novel diagnostic kit will identify women who are at~     high risk for preterm birth by a high positive predictive value.~   "
73699|NCT02092675|"~     The purpose of this study is to investigate the role of endothelial dysfunction in chronic~     obstructive pulmonary disease.~   "
73700|NCT02092662|"~     The purpose of this study is to evaluate by objective measures the improvement in upper~     extremity functioning, as reflection of motor learning, in stroke patients in the sub acute~     phase. The investigators hypothesize that the improvements in daily functioning are~     partially due to compensation strategies and partially due to motor learning.~   "
74085|NCT02087644|"~     A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with~     mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.~      Altogether 170 patients, randomized to two treatment groups will be included. Key outcome~     measures are patient reported parameters on their asthma~   "
73701|NCT02092649|"~     Fatty acids are the main components of the cell membranes. It has been demonstrated that~     diet can alter the characteristics and function of many membranes in the body, which has an~     effect on cardiovascular and metabolic health. Over the last two decades there has been a~     substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on~     bodily function. There are two fatty acids that are of particular interest to researchers,~     eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique~     unsaturated structures, and their incorporation into biological membranes seems to generate~     important and positive physiological effects. The body is unable to synthesize these fatty~     acids in high concentrations to elicit significant effects, so they must be obtained through~     diet in food or via supplementation.~      It has been suggested that EPA and DHA supplementation increases resting metabolic rate~     (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a~     limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have~     found an increase in RMR while others have found no change. These studies have some~     limitations, as that they have either used a small sample size, a low omega fatty acid dose~     and/or short supplementation periods. Due to the variable results, the investigators will~     improve the reliability of the RMR measurements by making measures on each subject during~     two consecutive days at each time point that it is measured (0, 6 and 12 weeks).~      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3~     supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The~     researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR~     and fat oxidation in some subjects and not in others. The duplicate RMR measures will~     determine the prevalence and magnitude of the omega 3 supplementation.~   "
73702|NCT02092636|"~     An imaging method has been developed that uses near infrared light as an adjunct to~     ultrasound for better diagnosis and for monitoring tumor response. This study will use a~     new, non-invasive way to evaluate breast lumps using a low power light source & ultrasound~     to see if breast lumps are benign or cancerous. This study will also evaluate if this new~     technique might be useful in assessing response to chemotherapy.~   "
73703|NCT02092623|"~     Definition: To find out complications, objective and subjective outcomes of patients with~     symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine~     Finnish hospitals during September 2010 and August 2013. The study hypothesis is that~     complications are acceptable and both objective and subjective outcomes are satisfying.~   "
73704|NCT02092610|"~     An international multicentre, open, comparative, parallel group, prospective clinical~     investigation with a single 5 year follow up visit.~   "
73705|NCT02092597|"~     The purpose of this study is to assess the effects of incretin-based antidiabetic therapies~     (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system~     and to detail the mechanisms underlying their action in these systems.~   "
73706|NCT02092584|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in~     patients with cardiovascular disease.~   "
73707|NCT02092571|"~     A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal~     women~   "
73708|NCT02092558|"~     Background: Squamous metaplasia refers to the pathological transformation of the urothelium~     leading to non-keratinised stratified squamous metaplasia (N-KSM).~      Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM~     of the urinary bladder in children.~   "
73709|NCT02092545|"~     Study to collect data on weight management on a male population of retired NFL athletes.~   "
73710|NCT02092532|"~     The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept~     injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.~   "
73711|NCT02092519|"~     Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for~     tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield~     of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of >90% may~     be expected, as compared to pancreatic masses, where lower diagnostic rates were reported.~     To maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and~     at least 4 passes for pancreatic masses. Olympus has recently made commercially available a~     new 22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The~     theoretical basis for introduction of the side port is to increase the diagnostic yield.~     Preliminary unpublished retrospective data suggested the yield might be raised. However,~     there are no prospective multicenter randomized controlled studies to ascertain the validity~     of the assumption.~      Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and~     EZ-Shot 2 with side port in patients with pancreatic masses for evaluation.~      Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively~     and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and~     then the alternative needle will be used for repeated punctured. The cytological and~     diagnostic yield at first pass for both needles will be compared.~      Clinical significance: This will determine whether the new needle design can further improve~     the diagnostic yield of EUSFNA of pancreatic masses.~   "
73712|NCT02092506|"~     Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and~     clarithromycin 500mg twice daily has long been considered one of the standard treatment for~     H. pylori infection as initial studies demonstrated success rates of > 90% on per protocol~     analysis (PP) and > 80% on intention to treat (ITT) analysis. However increasing bacterial~     resistance, especially to clarithromycin, has been reported and there are concerns that the~     efficacy of TT has decreased. Sequential therapy (ST) is an alternative first line therapy~     that consists of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment~     with the PPI and clarithromycin and metronidazole. The rationale for this approach is that~     amoxicillin may weaken the bacterial cell wall in the initial phase of treatment, and~     prevent the development of drug efflux channels that inhibit clarithromycin from binding to~     ribosomes and thus help to improve the efficacy of clarithromycin in the second phase of~     treatment. A recent meta-analysis based on mainly European studies showed that the success~     rate of ST compared to TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is~     another alternative first line treatment that consists of 10 days of PPI, amoxicillin,~     clarithromycin and metronidazole. The rationale for using CT as a first line treatment~     option is to address the possibility of clarithromycin resistance which is increasingly~     encountered in clinical practice. Currently there are no randomized controlled studies that~     compared TT with ST in Singapore, although both regimens are being used in routine clinical~     practice. The hypothesis is that ST is superior to TT as first line treatment for H. pylori~     infection.~      The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment~     for H. pylori infection in Singapore.~   "
80556|NCT02003001|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in left ventricle for preventing ventricular~     arrhythmias.~   "
73713|NCT02092493|"~     ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which~     provides real-time 3D image of the shape and configuration of the colonoscope as it travels~     through the colon. Whilst it is being used in clinical practice in most units in the UK, it~     is not a device which is routinely used on all lists, and most departments do not own enough~     ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by~     improving completion rates and times as well as patient comfort in selected endoscopists~     (persons who perform the colonoscopy). However data on its benefit have been conflicting.~      Subjective mental workload (the individuals mental resources required as a result of the~     multiple demands placed on him/her from a task)in healthcare employees is known to be~     important for the performance and safety of healthcare delivery. Increased workload during~     task performance may increase fatigue, facilitate errors and lead to overall inferior~     performance.~      In colonoscopy high mental workload could potentially be responsible for longer procedural~     time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor~     technique leading to patient discomfort. The effect of the endoscopist mental workload on~     their performance and potential facilitators to reduce mental workload is an area that has~     been neglected in this field.~      This study aims to look at the mental workload of endoscopist during colonoscopy and the~     effect ScopeGuide may have on this workload.~      Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the~     endoscopist performing the procedure~   "
73714|NCT02092480|"~     The If I Were Jack feasibility trial will test the acceptability and feasibility of using~     and evaluating a unique and scientifically informed educational resource on the topic of~     teenage men and unintended pregnancy in post-primary schools in Northern Ireland. The study~     is being conducted by a multidisciplinary team at Queen's University Belfast with~     collaborators and will begin in May 2014. It is a phase II feasibility trial with an~     embedded process evaluation, twenty four months in duration. The research will assess the~     feasibility and acceptability of the intervention and trial methods, and provide estimates~     for a phase III cluster randomised trial, including potential effect sizes and recruitment,~     retention and participation rates, so that the feasibility and optimal design of a~     full-scale trial can be ascertained. It will include an analysis of the costs of delivering~     the intervention and a process evaluation using a mixed-methods triangulated design to~     determine the acceptability of the intervention and research measures to participants and to~     establish fidelity to implementation protocol. Additionally, it will assess variation in~     normal practice of Relationship and Sexuality Education in participating schools in relation~     to teenage pregnancy.~   "
73715|NCT02092467|"~     This post-marketing study is designed to compare the safety of tofacitinib versus TNF~     inhibitor with respect to major cardiovascular adverse events and malignancies, excluding~     non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety~     events, including non-melanoma skin cancers, hepatic events, infections, and efficacy~     parameters will be collected and evaluated in the study.~   "
73716|NCT02092454|"~     To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain~     relief associated with acute otitis media.~   "
73717|NCT02092441|"~     Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal~     saline) pads to treat nausea in emergency department patients.~   "
73718|NCT02092428|"~     Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical~     Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary~     arteries using slow-infusion, contrast-enhanced data acquisition. This method allows faster~     data acquisition and better spatial resolution.~      Specific aims of this study are to:~        1. compare coronary artery imaging with and without contrast media on both healthy~          subjects and patients;~        2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to~          conventional x-ray angiography~      Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary~     arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI~     technique will accurately detect coronary artery disease (CAD) as compared to conventional~     x-ray angiography.~   "
73719|NCT02092415|"~     The goal of this study is to use contrast enhanced ultrasound to determine the degree to~     which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced~     ultrasound is performed to quantify thigh and calf perfusion at baseline and during~     application of the JT~   "
73720|NCT02092402|"~     The purpose of this study is to investigate the effect of fecal microbiota transplantation~     (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.~   "
73721|NCT02092389|"~     The objectives of this study are to explore the effect of adalimumab on the fecal~     Calprotectin level of Ulcerative Colitis (UC) patients and the correlation with their~     general well-being (QoL), work ability and disease activity.~   "
73722|NCT02092376|"~     The aim of the study is to increase vitamin D concentrations or to keep it on high level,~     respectively, by supplementing with vitamin D3 in a different dose regime, and to improve~     the overall health status in bariatric patients. In this project, the vitamin D status, the~     parameters of inflammation, bone turnover, insulin resistance, liver and depression score of~     bariatric patients are expected to improve, due to supplementation of a loading dose~     compared to the standard therapy.~   "
73723|NCT02092363|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be~     administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC~     = 5 mg/mL • min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of~     paclitaxel and carboplatin will be given. Additional cycles may be given as per~     institutional standard of care after discussion with the Medical Monitor. Treatment with~     OMP-54F28 will continue after completion of treatment with paclitaxel and carboplatin. The~     planned dose levels of OMP-54F28 are 5 and 10 mg/kg.~   "
73724|NCT02092350|"~     This study will evaluate the safety and efficacy of combination treatment with grazoprevir~     (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic~     Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The~     primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within~     the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained~     viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.~   "
73726|NCT02092324|"~     This phase II trial studies how well ruxolitinib phosphate works in treating patients with~     chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib~     phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for~     cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in~     cancer cells may determine how the cancer grows or spreads and how it may respond to~     different drugs. Studying how the genes associated with CNL and aCML respond to the study~     drug may help doctors learn more about CNL and aCML and improve the treatment for these~     diseases.~   "
73727|NCT02092311|"~     The purpose of this study is to determine the rates of major post-varicocelectomy~     complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new~     method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is~     that using this method will lead to less major complications of recurrence, hydrocele, and~     also less incidental injuries to the arteries that will result less testicular atrophy~   "
73728|NCT02092298|"~     The goal of this clinical research study is to learn if hyperthermic intraperitoneal~     chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or~     gastroesophageal cancer. The safety of this treatment will also be studied.~   "
73729|NCT02092285|"~     The primary objective of this study is to evaluate the efficacy of golimumab in maintaining~     a clinical response in participants with moderate-to-severe ulcerative colitis.~   "
73730|NCT02092272|"~     Patients will be randomly assigned to one of two groups using a random number generator.~     Group 1 will be provided with in-office instruction of standard of care eccentric exercises~     for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well~     as a instructional exercise video source (DVD) to take home as a reminder on how to perform~     two specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group~     will be given a card to track adherence to the standard of care eccentric exercise routine~     as measured only by the days that they accomplish their exercises. Study exercise diary will~     be collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard~     of care for rotator cuff tendinopathy.~   "
73731|NCT02092259|"~     The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for~     the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic~     patients.~      The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.~   "
73732|NCT02092246|"~     To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in~     obese patients with no clinically detectable effusion.~   "
73733|NCT02092233|"~     The ARIES HSV 1&2 Assay is a PCR based test for the direct detection and typing of herpes~     simplex virus (HSV 1 & 2) DNA.~      The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.~   "
73734|NCT02092220|"~     This study will test the hypothesis that a wearable bionic pancreas system that~     automatically delivers insulin and glucagon can provide superior regulation of glycemia vs.~     usual care for adults with type 1 diabetes.~      Please note that all participants must work or attend school at one of the following~     campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical~     Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford~     University in Palo Alto, CA.~   "
73735|NCT02092207|"~     This is a controlled study to determine the effectiveness and safety of KL7016 in the~     treatment of adult patients with dry eye syndrome (DES).~   "
73736|NCT02092194|"~     Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The~     supported mechanism is the improved clearance of uremic toxins by convective transporter.~     However, It has not been elucidated which convection volume is optimal, especially in Asia.~     A total of 60 participants receiving conventional hemodialysis will be randomly assigned to~     receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or~     standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of~     serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes~     will include changes in the nutritional markers, inflammatory markers, and blood pressure~     from baseline to after treatment.~      This would be the first multicenter prospective, randomized controlled trial to determine~     whether large convective volume improves the treatment efficacy in Korean patients~     undergoing post-dilution online HDF.~   "
73737|NCT02092181|"~     The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in~     treating symptoms of Overactive Bladder in people with Parkinson's Disease.~   "
73738|NCT02092168|"~     The purpose of this study is to determine the effects of age on the pharmacokinetic (PK)~     profile of BIA 9-1067 and its metabolites.~   "
73739|NCT02092155|"~     Some patients that have a tunneled pleural catheter will not have the pleural fluid (water~     around the lung) return after some time (pleurodesis). The purpose of this study is to~     understand how the investigators can predict who will achieve pleurodesis and how this~     occurs by studying the pleural effusion.~   "
73740|NCT02092142|"~     The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I,~     Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection~     in vaccinated personnel.~   "
73741|NCT02092129|"~     Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We~     hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have~     prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic~     patients. The aim of this study is to examine glucose metabolic outcome in acromegalic~     patients with and without histologically verified prolactin and growth hormone (GH)~     co-secreting adenomas. The study population include 79 patients who have all undergone~     surgical treatment for acromegaly.~   "
73742|NCT02092116|"~     The REDUC (Kick and Kill) trial's objective is to address one of the core issues with the~     treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs.~     The reservoirs are unaffected by conventional HIV medication and invisible to the immune~     system. HDACi have the potential to activate (Kick) these latently infected cells. This~     will make the HIV infected cells visible to the immune system; the immune response generate~     by Vacc-4x will be able to attack and eliminate (Kill) the infected cells.~   "
87339|NCT01914328|"~     The purpose of this study is to determine the incidence of pulmonary complications in~     patients undergone major abdominal elective surgery performed under general anesthesia.~   "
73743|NCT02092103|"~     This is a randomized controlled trial that will compare the effects of delayed umbilical~     cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation).~     The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU)~     will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular~     hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior~     to clamping is superior to simply delayed cord clamping, presumably providing an increased~     blood volume to the preterm neonate improving its outcomes.~   "
73744|NCT02092090|"~     The study is a large scale cluster randomised trial to evaluate the effects of sodium~     reduction based upon the use of salt substitute on the risk of stroke defined as the~     occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be~     tested is that sodium reduction will have no effect upon stroke risk. The secondary~     objectives are to determine effects of sodium reduction on major vascular events and total~     mortality.~   "
73745|NCT02092077|"~     The purpose of this study is to support selection of an appropriate safe and efficacious~     dose for study in further development.~   "
73746|NCT02092064|"~     to investigate the effect of basal proteinuria on pregnancy outcomes of patients with~     Familial Mediterranean fever (FMF).~   "
73747|NCT02092051|"~     Breif summary~      A keystone in preventing diabetic complications in patients with type 1 diabetes is good~     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an~     essential part of insulin dosing before meals. However, in recent years continuous glucose~     monitoring (CGM) has become a treatment option for notifying the patient on trends in~     glucose levels and warning when these are estimated to be too high and too low.~      In some countries today, Sweden among others, CGM is reimbursed in combination with~     continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic~     control or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients.~     This is based on existing clinical trials showing a beneficial effect on HbA1c by combining~     CGM with CSII. However, the majority of adult type 1 diabetic patients are treated with~     multiple daily insulin injections (MDI). Clinical trial data are sparse on the effect of CGM~     in adult type 1 diabetic patients treated with MDI, and there are no clinical trial data~     including only patients on MDI.~      The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction~     among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week,~     cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with~     conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included~     at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage~     unit) change in HbA1c resulting from CGM.~   "
73748|NCT02092038|"~     Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and~     radiation therapy, followed by surgery and then further temozolomide.~   "
73749|NCT02092025|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of~     azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical~     setting.~   "
73750|NCT02092012|"~     The aim of this study is to investigate comparison of preemptive analgesic effects of~     dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal~     hysterectomy.~   "
73751|NCT02091999|"~     The purpose of this study is to evaluate the safety and pharmacokinetics ASG-22CE as well as~     assess the immunogenicity and antitumor activity in subjects with metastatic urothelial~     cancer and other malignant solid tumors.~   "
73752|NCT02091986|"~     The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and~     Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in~     Children Ages 6 to <12 Years with Asthma during 12 weeks.~   "
73753|NCT02091973|"~     The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as~     nephrotoxicity. However, these drugs are essential for kidney transplant especially in high~     immunological risks. To date, however, there is an alternative regimen by using of~     everolimus-based which showing less toxicity than tacrolimus-based regimen by its~     mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles~     detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney~     transplantation.~   "
73754|NCT02091960|"~     The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in~     subjects with HER2+ AR+ metastatic or locally advanced breast cancer.~   "
73755|NCT02091947|"~     Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous~     systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve~     near the third sacral root induces relaxation of the detrusor muscles and reinforcement of~     urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on~     stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term~     effect of this method on stress urinary incontinent patients.~   "
73756|NCT02091934|"~     The purpose of the study is to compare the results of PRKK surgery when using~     wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser~     treatment in patients with nearsightedness with and without astigmatism~   "
73757|NCT02091921|"~     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb~     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a~     major cause of death and disability (secondary to myocardial infarction, stroke and~     amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five~     years respectively. High on-treatment platelet reactivity (HPR) in patients treated with~     aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events~     after percutaneous coronary interventions and coronary syndromes. Preliminary studies~     suggest that the prevalence of HPR in patients with critical limb ischemia treated with~     aspirin and clopidogrel is as high a 78.5%. In patients with coronary artery disease~     ticagrelor overcomes non-responsiveness to clopidogrel. However, the antiplatelet effect of~     ticagrelor in patients with critical limb ischemia is unknown.~   "
73758|NCT02091908|"~     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18~     through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying~     medical conditions.~   "
73759|NCT02091895|"~     The aims of this research are to validate and develop of therapeutic strategies for patients~     with colorectal lesions in real time through pCLE(probe-based confocal laser~     endomicroscopy). Endomicroscopy is a technique for obtaining histology-like images from~     inside the human body in real-time. Total objections are 311 patients.~      Specific research topics are as below.~        1. Diagnosis and classification of colon polyps through pCLE~        2. Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor~          through the pCLE~        3. Differential diagnosis of colorectal submucosal tumor through the pCLE~        4. Differential diagnosis of ileocecal ulcers through the pCLE~      The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric~     predict of pCLE diagnosis, and calculate the agreement of prediction compared to the~     pathological findings of lesions Check diagnostic agreement of technical phrases which are~     derived, the matching degree between observers, and will develope a new classification~     method based on this.~   "
73760|NCT02091882|"~     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System~     by completing a series of Patch applications and IEM ingestions in the clinic.~   "
73761|NCT02091869|"~     The purpose of this study is to see if using a mobile phone application asthma action plan~     will help improve asthma management.~   "
73762|NCT02091856|"~     Project aim: To compare the effectiveness and acceptability of a conventional and a~     religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.~   "
73763|NCT02091843|"~     Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans~     returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage~     of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients~     suffering from PTSD experience intense suffering, lack of productivity and a higher risk of~     suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments.~      The central goal of this project is to develop a new therapeutic strategy involving the~     placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on~     recent evidence showing abnormal activity in a specific brain region of PTSD patients,~     thought to be responsible for the core symptoms of PTSD.~   "
73764|NCT02091830|"~     The purpose of this study is to assess whether radiographic osteoarthritis severity (OA;~     Kellgren-Lawrence scale) is associated with self-reported improvement in pain after~     non-surgical treatments (physiotherapy, pain killers, injection, other treatments).~      The hypothesis is that radiographic OA severity is inversely associated with self-reported~     improvement.~   "
73765|NCT02091817|"~     The purpose of this study is to determine whether oxytocin affect face perception~   "
73766|NCT02091804|"~     The purpose of this study is to to conduct a randomized controlled trial comparing an~     intervention group and a control/wait list group to evaluate the feasibility of the~     Promoting First Relationships method in an American Indian community through their tribal~     Maternal and Child Health program, and to assess the efficacy of the method in this~     community.~   "
73767|NCT02091791|"~     The aim of this study is to compare two levels (high and low forces) of short term lumbar~     traction on pain and functional tests of the lower limbs in a specific population of~     patients presenting with acute lumbar sciatica secondary to disc herniation. The~     investigators hypothesize that, in this particular medical condition, high level of lumbar~     traction might be more effective than low level lumbar traction in decreasing the pain~     associated with acute sciatica.~   "
73768|NCT02091778|"~     The primary objective of this post market clinical follow-up (PMCF) investigation is to~     evaluate performance and safety of fast gelling dressing when used as intended in Diabetic~     Foot Ulcer (DFU).~      The primary endpoint will be Changes from baseline in the condition of the peri-wound skin~     measured by the following variables; maceration, redness/irritation, rash/eczema,~     blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the~     skin~   "
73769|NCT02091765|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of an~     internet-based cognitive behavioural therapy program in alleviating problems with intimacy~     and sexuality in women treated for breast cancer.~   "
73770|NCT02091752|"~     The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after~     treatment interruption due to loss of response and/or adverse events.~   "
73771|NCT02091739|"~     The objective of this study is to investigate the efficacy and safety of two different dose~     levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary~     flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a~     result of various neurological conditions in adult subjects.~   "
73772|NCT02091726|"~     This is a field trial of the Unicirc instrument to excise the foreskin, plus use of~     cyanoacrylate tissue adhesive to seal the wound.~   "
73773|NCT02091713|"~     Emerging evidences indicate that performance on a variety of functional movement screens can~     identify athletes/soldiers at risk for injury. These field expedient tests have not been~     validated in a military setting or across different military occupational specialties. In~     this prospective study the investigators plan to screen 300 combatants for a 1-year time~     frame in order to validate the suggested algorithm of a list of modifiable and~     non-modifiable risk factors which are hypothesized to predict injury risk during the~     military service.~   "
73774|NCT02091700|"~     To develop a database of the peripheral retinal circulation using ultra widefield~     fluorescein angiography (UWF-FA) imaging for the Optos COE platform. This database will~     serve as a quantitative reference tool for the comparison of subjects to a database of known~     normal subjects.~   "
73775|NCT02091687|"~     Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who~     previously participated in a randomized, controlled trial (RCT) of intensive therapy~     combined with repetitive Transcranial Magnetic Stimulation (rTMS)~   "
73819|NCT02091115|"~     Constipation is a disorder which can be associated with various pathologies or could also be~     an effect of the consumption of drugs, improper diet and life style. Is increasingly common~     the utilization of probiotics in foods. Probiotics are defined as live microorganisms~     administered in adequate amounts confer a health benefit to the host, the most widely used~     for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective~     of the present study is to assess the effectiveness of the consumption of dairy beverage~     enriched with probiotic for the treatment of the symptoms of constipation.~   "
73776|NCT02091674|"~     To determine the efficacy and safety of hyaluronic acid (AdantTM, Tedec-Meiji Farma SA) for~     acute ankle sprain, a single-site, open-label, controlled trial will be conducted.~      The study will be conducted in a sport-medicine clinical research center in London, Ontario,~     Canada. The eligible patients will be 18 years of age and older, have first or second degree~     lateral sprain within 48h of the start of the treatment, and moderate or severe pain (>45mm~     on 100 mm pain visual analogue scale /VAS). Exclusion criteria will include bilateral ankle~     sprain, ipsilateral knee trauma, prior sprain in the past 6 months, use of NSAID prior to~     entry, intra-articular ankle injection in the prior 6 months.~      The patients will receive standard care (RICE and rescue analgesics), and a single 2.5cc~     Adant periarticular ankle injection following provision of informed consent and collection~     of baseline data. NSAIDs, corticosteroids or topical analgesics will not be allowed.~      Assessments will be done at baseline, days 8, 30 and day 90. Efficacy measures will include~     patient's pain VAS on weight bearing (0-100mm) and walking 20m (0-100mm), patients' global~     assessment of ankle injury (5 point categorical scale), patients' assessment of normal~     function/activity (5 point categorical scale), physician's global assessment of ankle injury~     (5 point categorical scale), patients/physician satisfaction assessment (10 point~     categorical scale), time to return to pain-free and disability-free sport and adverse events~     as per WHO definition.~      It is expected that the Hyaluronic acid injections will decrease pain and swelling, promote~     healing, improve time to return to sport and increase mobility.~   "
73777|NCT02091661|"~     The purpose of this study is to evaluate the effectiveness of the two most established~     primary treatments for patients with clinically localized prostate cancer: radical~     retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing~     biochemical disease-free survival, overall survival, and prostate cancer-specific survival.~     As secondary objectives quality of Life impact of treatments' side effects will be also~     assessed.~   "
73778|NCT02091648|"~     The purpose of the proposed study is to conduct a randomized controlled pilot trial of a~     school-based stress management and coping skills training program among a sample of~     economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed~     asthma. The investigators aim (1) to establish feasibility of this approach by recruiting~     from different schools and (2) to learn whether individuals assigned to receive the~     intervention show improvements in psychological function, decreases in lung inflammation,~     and related improvements in asthma health when compared with disease severity-matched peers~     who receive education-only or standard care.~   "
73779|NCT02091635|"~     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper~     abdominal pain or discomfort in the absence of a specific structural cause. Improving~     gastric accommodation and prokinetic effect seem to be an attractive physiological target in~     patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was~     launched in December 2011 in Korea for treating patients with FD. The current study aims to~     evaluate effects of motilitone on gastric accommodation and emptying after a meal in a group~     of healthy volunteers using three-dimensional gastric volume measurements by magnetic~     resonance imaging (MRI). Healthy volunteers are randomly allocated to receive either~     motilitone or placebo in a double blinded manner. After 5 days of treatment, subjects~     undergo gastric MRI. The primary endpoint is gastric accommodation.~   "
73780|NCT02091622|"~     Introduction: Honest prognostication and information for patients are important parts of~     end-of-life care. This study examined whether an educational intervention could increase the~     proportion of patients who received information about the transition to end-of-life care~     (ITEOL).~      Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to~     receive an interactive half-day course about ITEOL for physicians and nurses. The proportion~     of patients who received ITEOL was measured with data from the Swedish Register of~     Palliative Care (SRPC). Patients were only included if they died an expected death and~     maintained their ability to express their will until days or hours before their death. Four~     hospitals and four municipalities were assigned controls, matched by hospital size,~     population, and proportion of patients receiving ITEOL at baseline.~   "
73781|NCT02091609|"~     This aim of this study is to compare different oral hygiene aids for the ability to remove~     plaque in patients who went through dental implant treatment and are currently on a~     maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba,~     Faculty of Dentistry.~   "
73782|NCT02091596|"~     This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50~     enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly~     infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis~     but not involving joint capsule, tendon, and bone). Subjects must also provide informed~     consent and meet all other entry criteria to be enrolled and randomly assigned to receive~     PluroGel N or PluroGel vehicle.~   "
73783|NCT02091583|"~     The purpose of this study is to examine the effects of consumption of a novel food~     supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food~     bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty~     acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk~     factors in people with metabolic syndrome and to test its efficacy and safety in humans.~   "
73784|NCT02091570|"~     This study investigates nutrition bar consumption and possible impact on self-reported~     ratings of hunger and fullness compared to a control.~   "
73785|NCT02091557|"~     To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of~     the combination of two simple parameters: modifications of serum CA 125 and VAS pain score~     following one dose of GnRH-analog (GnRH-a).~   "
73786|NCT02091544|"~     Children and adolescents with overweight and obesity are predisposed to significant health~     problems. It is known that childhood obesity can adversely affect almost every organ system,~     and if left untreated, the major impact of childhood overweight is likely to be felt in the~     next generation of adults.~      The aim of  Kijk op overgewicht bij kinderen is to collect and follow-up longitudinal data~     from a population of different degrees of children with overweight regarding etiological~     factors, risk factors and early stages of chronic disease in different degrees of childhood~     overweight.~   "
73820|NCT02091102|"~     The purpose of this study is to evaluate the efficacy and safety of the treatment of~     wrinkles using a 755nm Alexandrite Laser.~   "
73787|NCT02091531|"~     This is a phase II study which will test the study drug MLN0128 in patients with castration~     resistant prostate cancer who have received chemotherapy in the past. Phase II clinical~     trials test how well an investigational drug works in treating a specific cancer.~     Investigational means that the drug is still being studied and that research doctors are~     trying to find out more about it. MLN0128 is not approved by the FDA.~      The purpose of this study is to see what effects (good and bad) the study drug MLN0128 has~     on the patient and the cancer. MLN0128 is a drug that belongs to a class of drugs called~     mTOR kinase inhibitors. A protein, called mTOR inside the cells in the body, plays a~     role in controlling how cells grow. In some cancer cells, mTOR may be over-active. This~     over-activity may cause some cancer cells to grow out of control. Research has shown that~     mTOR inhibitors can block this overactivity and may help stop or slow down the growth of~     some types of cancer cells.~   "
73788|NCT02091518|"~     Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and~     improvement in the way the MRI images are obtained. Many of these advances involve changes~     to MRI software and hardware. The goal of this study is to find out the possible benefits of~     new MRI techniques. This will allow us to use the new MRI methods in research and patient~     care.~   "
73789|NCT02091505|"~     Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis~     (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion~     (CRVO). However, there is little information on whether there are any predictive factors of~     treatment outcome after this treatment. We plan to perform comprehensive functional and~     imaging tests to determine significant predictive factors.~   "
73790|NCT02091492|"~     This study will test the hypothesis that daily subcuaneous administration of 20µg of~     teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates~     proximal 2-segment humerus fracture healing and improves the three dimensional structural~     properties of bone as measured via quantitative bone image analysis and finite element~     modeling assessed by quantitative computed tomography.~   "
73791|NCT02091479|"~     In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is~     recommended in some situations, including when major hæmorrhage occurs. But withdrawing~     treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment~     withdrawal heightens the risk of thromboembolic events occurring, with potentially major~     consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients.~     Resumption of anticoagulation is therefore critical in patients at high risk for~     thromboembolic events.~      However, in these patients having presented major hæmorrhage, resumption of anticoagulation~     heightens the risk of hæmorrhage recurrence. This risk is even higher when the original~     hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.~      As far as investigators know, there is no data in the literature to rely on when the major~     hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high.~     When confronted with patients who need anticoagulation but have a high risk of hæmorrhage~     recurrence, the question of when treatment should be resumed has not been resolved. This is~     why investigators propose to conduct a randomised comparative study to evaluate two~     treatment strategies - early resumption (H48 to H72) versus late resumption (H120 to H144)~     of anticoagulation.~      MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding~     risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of~     anticoagulation in patients having presented with serious hæmorrhage while on curative-dose~     anticoagulants and facing a high thromboembolic risk.~   "
73792|NCT02091466|"~     Background: Hypothermia is common during general and regional anesthesia even when active~     warming measures are taken. The existing literature shows that, in pregnant patients, the~     use of forced air-warming during cesarean section under spinal anesthesia does not prevent~     maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming~     system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in~     pregnant women subjected to elective cesarean delivery.~      Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal~     anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal~     gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the~     preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery.~     After the anesthesia, the thermal gown was moved from the regular position and placed over~     the chest and upper limbs, as an upper body blanket, and maintained throughout the study.~     The following variables were observed: preoperative and operative room temperature,~     hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the~     preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal~     anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for~     baseline values.~   "
73793|NCT02091453|"~     Background: To study intensive targeted cognitive rehabilitation of attention in the acute~     (<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury~     and to evaluate the effects on function, activity and participation (return to work).~      Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with~     stroke or traumatic brain injury are randomised to 20 hours of intensive attention training~     by Attention Process Training or by standard, activity based training. Progress is evaluated~     by Statistical Process Control and by pre and post measurement of functional and activity~     levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the~     changes in the attention measure, Paced Auditory Serial Addition Test and changes in work~     ability. Secondary endpoints include measurement of cognitive functions, activity and work~     return. There are 3, 6 and 12-month follow ups focussing on health economics.~      Discussion: The study will provide information on rehabilitation of attention in the early~     phases after acquired brain injury (ABI); effects on function, activity and return to work.~     Further, the application of Statistical Process Control might enable closer investigation of~     the cognitive changes after acquired brain injury and demonstrate the usefulness of process~     measures in rehabilitation.~   "
73794|NCT02091440|"~     The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in~     patients listed for cardiac transplantation with refractory, advanced heart failure at risk~     of death.~   "
73821|NCT02091089|"~     The purpose of this study is to evaluate the efficacy and safety of the treatment of~     wrinkles using the picosecond 755nm Alexandrite laser.~   "
73795|NCT02091427|"~     Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the~     concentration of cardiac troponin, with at least one value above the 99th percentile value~     of the reference population together with evidence of ischemia. An objective tool to~     determine the magnitude of the cardiac troponin change is the use of reference change values~     (RCV). The basis for this tool is that, for a change to be significant, the difference in~     serial results must be greater than the inherent variation in two test results. The inherent~     variation of a laboratory test result is composed of analytical and within-subject~     biological variation. An important requirement to use RCVs is that the concentrations of~     cardiac troponins fluctuate randomly around a homeostatic set point in cardio-healthy~     individuals. Verification of this important condition has never been performed, and~     violation of this condition would preclude the use of RCV's in clinical practice.~   "
73796|NCT02091414|"~     This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in~     combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and~     steroids, in patients receiving a heart transplant. The anticipated time on study treatment~     is 24 weeks.~   "
73797|NCT02091401|"~     The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate~     administered by the Springfusor® controlled pump to a continuous intravenous regimen. The~     goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum~     magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the~     continuous intravenous and Springfusor repeat bolus regimens. The study will also document~     the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.~   "
73798|NCT02091388|"~     This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well~     as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat~     injections~   "
73799|NCT02091375|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet syndrome.~   "
73800|NCT02091362|"~     The main purpose of the trial is to determine the effect of a study drug known as LY2409021~     on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when~     compared to placebo. The study has two periods. Each participant will receive LY2409021 or~     placebo in each period. At least 4 weeks will pass between periods. The study will last~     about 23 weeks for each participant. Participants may remain on stable dose metformin, as~     prescribed by their personal physician.~   "
73801|NCT02091349|"~     The objective of this study is to determine the tolerance and utilization of polydextrose~     and soluble corn fiber through analyses of fecal samples of fermentative end-products~     (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.~   "
73802|NCT02091336|"~     The aim of this study is to determine the efficacy of oral treatment with glyburide and~     metformin controlling excessive fetal growth in women with gestational diabetes, using~     insulin as a ransom on no response to oral treatment .~      It is randomized with women who seek care at the Outpatient Diabetes in Pregnancy in our~     hospital trial Eligible women between 18 - 45anos diagnosed with gestational diabetes ,~     according to the WHO criteria , ratified the public network for prenatal care at the Clinic~     for Diabetes and Pregnancy HCPA .~      Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of~     enrollment.~      Pregnant women with indication for pharmacological treatment will be invited to~     randomization to use of oral , glyburide or metformin antidiabetic .~      At regular intervals of 2 - 3 weeks fetal growth will be measured with obstetric~     ultrasonography , until birth.~      The primary outcomes will be :~      ( 1 ) weight and gestational age at birth and the index of large for gestational age fetuses~     ( ≥ 90th percentile for gestational age ) ( 2 ) the use of insulin to achieve glycemic~     targets according to fetal growth , as an indirect measure of the inefficiency of oral~     medications .~   "
73803|NCT02091323|"~     The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM)~     and a body mass index(BMI)>35kg/m2 is clear. There are large-scale patients with T2DM in~     Chinese population and currently about two-thirds of them are lack of adequate blood glucose~     control. Asian Chinese have different type of obesity, different style of diet, and a~     relatively low BMI levels as well. We assess the feasibility and efficacy of laparoscopic~     roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking~     into account the differences of body size and diet between the United States & Europe and~     Asian countries, diabetic situation has its special features in different regions,~     especially in Asia China. Asian Chinese have a high incidence of T2DM and a relatively low~     BMI levels. Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects~     with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this~     operation become necessary.The patients will be followed up for one year after surgery and a~     comparison would be made between the two groups. Clinical indicators that reflect the effect~     of LRYGB are monitored before surgery and 1, 3,6,12 months after surgery. Complete remission~     of diabetes was defined by hemoglobin A1c (HbA1c)<6.0% and Fasting plasma glucose~     (FPG)<5.6mmol/L.~   "
73804|NCT02091310|"~     In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this~     Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by~     evaluating its effect on QT/QTc prolongation in healthy male and female subjects. According~     to the guidelines, such studies should typically be performed at the expected therapeutic~     dose and a supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.~      GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy~     overweight subjects (study GFT505-111-7), and both safety and tolerability were very good.~     However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d.~     Therefore, the current TQT study will be preceded by a multiple ascending dose study in~     which the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding~     to 2.5 and 3 times the expected therapeutic dose will be evaluated. The highest dose level~     for which safety and tolerability are considered satisfactory will be the supra-therapeutic~     dose used in the TQT study.~   "
73908|NCT02089958|"~     Incisional hernias are one of the most frequent complications in abdominal surgery.~     Laparoscopic repair is widely used but even not standardized. Existing data from different~     study designs show no representative data resulting in a lack of comparability and evidence.~     Therefore the standardization of operative techique has been proposed by the LIPOM-study~     group and will be assessed in a prospective manner.~   "
73805|NCT02091297|"~     More and more women are on buprenorphine or methadone during pregnancy for a history of~     opioid addiction. Currently, pain control after cesarean section for women already on these~     medications, if they need operative delivery, is a challenge due to the pharmacology of~     those drugs. They have higher pain scores and 45-47% higher opiates requirement. To improve~     pain control, some unique regional anesthesia techniques have been employed, besides opioid~     and non-opioid medication management through the oral, intravenous, and/or neuraxial (spinal~     or epidural) route. One is a TAP block ( transversus abdominis plane block), a regional~     anesthesia procedure in which long acting local anesthetic, such as ropivacaine, is injected~     on both sides of the patient's abdomen to numb the nerves supplying the abdominal wall, or~     the surgical site. Another is a patient - controlled epidural, a small flexible catheter~     that is inserted in the back into the epidural space near the spine, which bathes the spinal~     nerve roots with long acting local anesthetic, such as bupivacaine, and with an opioid, such~     as fentanyl, to numb the nerves going to the surgical site. Through an epidural pump, the~     patient receives a continuous infusion of local anesthetic and can delivery more medication~     as needed through a bolus feature. There have case reports, or case by case accounts, of~     these techniques, and it is suspected these techniques result in better pain control with~     minimal side effects. No clinical, human or animal, has evaluated these techniques in a~     controlled and through manner, either comparing the two techniques to each other or~     comparing them to the common care of opioid and non-opioid medication management through the~     oral, intravenous, and/or neuraxial route, including neuraxial hydromorphone or morphine.~   "
73806|NCT02091284|"~     In this study, eligible alcoholic inpatients recruited from a specialized clinic for~     addiction treatment, filling inclusion criteria and not showing any exclusion criteria, will~     be randomized to receive the repetitive (5 sessions, every other day) bilateral dorsolateral~     Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for~     20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine will be examined before~     (baseline), during and after the end of the tDCS treatment. Other clinical outcomes, and~     also visual P3 event-related potential and neuroimagings exams will be also performed before~     and after treatment.~      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will~     favorably change clinical, cognitive and brain function in alcoholism and these will be~     long-lasting effects.~   "
73807|NCT02091271|"~     The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB~     approved research studies involving human subjects, both normal volunteers and patients. As~     a means of identifying interested volunteers and other participants in the research process,~     this screening mechanism is established to identif'y potential eligible participants for NlA~     protocols.~      To participate, volunteers/patients must meet the specific requirements of at least one of~     the available NlA research studies; this protocol serves as a first step for admitting~     volunteers/patients to an appropriate approved protocol and creating a contact database for~     approved NlA studies.~      This protocol will facilitate their recruitment into NIA approved studies and provide NlA~     staff the opportunity to examine subjects where diagnostic observations can be documented~     and evaluated for research potential.~   "
73808|NCT02091258|"~     Tooth loss in periodontitis patients is associated with patient and site factors as well as~     with treatment provided. Not much is known about long-term tooth loss in periodontitis~     patients in private practice in the UK. The study plans to follow-up 200 subjects with~     periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment~     provided, site and patient risk factors on tooth loss will be studied.~   "
73809|NCT02091245|"~     This research study involves participants who have acute lymphoblastic or acute myelogenous~     leukemia that has relapsed or has become resistant (or refractory) to standard therapies.~     This research study is evaluating a drug called KPT-330. Laboratory and other studies~     suggest that the study drug, KPT-330, may prevent leukemia cells from growing and may lead~     to the destruction of leukemia cells. It is thought that KPT-330 activates cellular~     processes that increase the death of leukemia cells. The main goal of this study is to~     evaluate the side effects of KPT-330 when it is administered to children and adolescents~     with relapsed or refractory leukemia.~   "
73810|NCT02091232|"~     This research study is for patients who are going to receive a kidney transplant from a~     living donor. After kidney transplantation, it is necessary for transplant recipients to~     take immunosuppressive drugs. These drugs work by preventing the body's immune cells from~     attacking and rejecting the new kidney. Taking these drugs long-term may also cause harm~     to the transplanted kidney. Therefore, the transplant community is very interested in~     finding ways to decrease immunosuppressive drug treatment and further reduce the risk of~     kidney rejection. One method to do so is known as induction of tolerance, which is when~     the person who receives a transplant has treatment to make their immune cells tolerant to~     the donor cells.~      In this study, we will try to induce tolerance by mixing recipient cells and their donor's~     cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that~     attaches to immune system cells, interferes with the immune response and results in~     tolerance induction.~      After we mix the recipient cells with the donor's cells, we will sort out one particular~     kind of immune cell, called a regulatory T cell, and inject them back into the recipient.~     Regulatory T cells are the cells that are affected by induction to reduce rejection of~     donated organs. This method for inducing tolerance has been used in bone marrow~     transplantation, but this is the first time it is being done in kidney transplantation.~      This study is being conducted as part of a unique collaboration of US and EU centers called~     The ONE Study. The ONE Study centers have agreed to work together using common protocols and~     procedures but with each testing their own regulatory population for safety and the ability~     to promote kidney survival. Sharing data among the participating sites will permit a deeper~     understanding of how and why some treatments might succeed while others work less well.~   "
73831|NCT02090959|"~     Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which~     develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is~     important for maintaining normal muscle structure and function. Loss of dystrophin causes~     muscle fragility that leads to weakness and loss of walking ability. A specific type of~     mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy~     in approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense~     mutation. The main goal of this Phase 3 extension study is to obtain long term safety of~     ataluren in boys with nonsense mutation dystrophinopathy as determined by adverse events and~     laboratory abnormalities. The study will also assess changes in physical function, pulmonary~     function and other important clinical and laboratory measures.~   "
74331|NCT02084394|"~     Cardiac surgery is associated with multiple events and issues that increase risk for adverse~     postoperative neurological outcomes including postoperative cognitive dysfunction. The risk~     for postoperative delirium is generally thought to result from some previous health factors~     added to the susceptibility of the cardiac surgery process.~   "
73811|NCT02091219|"~     The purpose of this study is to compare the effects of two different forms of vitamin D~     supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the~     blood, and on markers of skeletal and immune health. This study is designed as a pilot~     study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African~     American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will~     undergo a screening visit during which a medical history will be taken, a physical exam~     performed, a dietary questionnaire administered, and blood collected. The purpose of the~     screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml)~     individuals who are candidates for vitamin D supplementation. Eligible patients will then be~     randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16~     weeks. After initiating supplementation, study patients will return for follow-up visits at~     weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the~     blood, as well as markers of skeletal and immune function. Participation in this study will~     therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which~     participants will receive their study supplements, 3 follow-up visits). After all data is~     collected, changes in vitamin D levels in the blood following supplementation with either~     vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance~     and immune function. Knowledge gained from this study may have a significant impact on how~     vitamin D status is defined, and how vitamin D repletion is administered.~   "
73812|NCT02091206|"~     To evaluate the safety and pharmacokinetics of multiple doses of GWP42003-P compared with~     placebo in children with Dravet syndrome.~   "
73813|NCT02091193|"~     The purpose of this study is to evaluate the effects of krill oil supplementation in~     patients with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements.~      Patients who enroll in this study will be asked to visit the Western Connecticut Health~     Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4~     weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo.~     Patients will be randomized into one of two groups to determine the order in which they~     receive the supplement and placebo. Every patient will receive both the krill oil and the~     placebo, but both the coordinator and the patient are blinded to which is which. At each~     visit, participants will undergo a non-invasive test which measures the function of the~     inner lining of blood vessels and they will also have blood drawn. Fasting is required~     before each appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose,~     HDL, LDL, total cholesterol, C-peptide and total antioxidant capacity.~      Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy~     taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are~     not permanent and may include pain, numbness, tingling, redness, and bruising at the site of~     the blood pressure cuff. Risks that are associated with drawing blood may include redness,~     swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare~     cases, infection at the needle site. To minimize these risks, trained technologists and~     phlebotomists will be used for all procedures.~      This is not a treatment option; while involved in this study all participants will continue~     their regular treatment for Type 2 diabetes mellitus (as well as any other applicable~     conditions).~   "
73814|NCT02091180|"~     Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for~     laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease~     in cerebral perfusion pressure.~   "
73815|NCT02091167|"~     In this study, eligible crack-cocaine addicted inpatients recruited from a specialized~     clinic for addiction treatment, filling inclusion criteria and not showing any exclusion~     criteria, will be randomized to receive the repetitive (5 sessions, every other day)~     bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2~     milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of~     crack-cocaine will be examined before (baseline), during and after the end of the tDCS~     treatment. Other clinical outcomes, and also visual P3 event-related potential and~     neuroimagings exams will be also performed before and after treatment.~      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will~     favorably change clinical, cognitive and brain function in crack-cocaine addiction and these~     will be long-lasting effects.~   "
73816|NCT02091154|"~     The investigators hypothesize that the new United States Department of Agriculture (USDA)~     regulations for lunches served as part of the National School Lunch Program will decrease~     the percentage of enrolled students purchasing lunch, increase the percentage of children~     taking fruit and vegetables, decrease the percentage of fruit and vegetable servings being~     thrown away, and increase the total number of fruit and vegetable servings eaten.~      The investigators also hypothesize that when the regulations are in force, simple behavioral~     interventions can counteract the potentially negative impact on lunch sales and consumption.~     In other words, implementing the regulations and behavioral interventions together, the~     percentage of enrolled students taking a school lunch will increase at least back to~     baseline levels, the percentage of children taking fruits and vegetables will increase, the~     percentage of fruit and vegetable servings wasted will decrease, and the total number of~     fruit and vegetable servings eaten will increase.~   "
73817|NCT02091141|"~     This is a multicenter, non-randomized, open-label study designed to evaluate four treatment~     regimens in patients with advanced cancer for whom there is no available, beneficial~     treatment. Patients with HER2 overexpression, amplification, or -activating mutation will be~     treated with Herceptin/Perjeta; those with epidermal growth factor receptor (EGFR), with~     Tarceva; those with BRAF-activating mutation, with Zelboraf/Cotellic; and those with Hedehog~     pathway potentially clinically relevant mutation, with Erivedge. Treatment will continue~     until disease progression or unacceptable toxicity occurs. Study is expected to last up to 5~     years.~   "
73818|NCT02091128|"~     With this study, in which the incidence of pregnancy in classic galactosemia patients is~     studied, we aim to provide new insights to improve counselling. Our hypothesis is that the~     chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has~     been reported for women with POI due to other causes. Chance of spontaneous pregnancy will~     be evaluated through semi standardized interview in women with classic galactosemia aged 18~     years or older. During the interview, questions will be asked regarding fertility and~     pregnancy.~   "
73822|NCT02091076|"~     A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be~     closed by primary and secondary wound closure. Accelerated re-epithelialization rate and~     minimizing pain and infection are main goals of donor care. Traditionally dressings are~     inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have~     developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin~     and silk sericin were selected to produce wound dressing in this study. The objective of~     this study is to compare wound dressing containing silk fibroin with bioactive coating layer~     with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to~     healing time, patients' pain intensity, skin's transepidermal water loss after healing and~     evidence of infection in the treatment of split-thickness skin graft donor sites. The study~     design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years~     and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital~     will be recruited in the study. The exclusion criteria are donor sites other than thigh area~     or located at high risk of infection. Patients who are immunocompromised or diabetes~     mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known~     allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects~     sign the informed consents after discussion the protocol, benefits and risks. The donor site~     will be divided into two equal halves, each site will be randomized to receive the tested~     material or the medicated paraffin gauze dressing. The donor site wounds will be observed~     daily. The dressings will not be changed, except when they are fully soaked with exudates~     and easily fell off or any sign of infection. Healing time will be recorded when the~     dressing separate completely from the donor site, no exudates and no pain when the donor~     site is exposed to air. The patient's pain level will be evaluated with the visual analogue~     scale and the donor site wounds will be observed daily for signs of infection. On the day of~     the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the~     skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample~     will be collected from patients pre- and postoperatively (within day 3) for hepatic and~     renal function analysis.~   "
73823|NCT02091063|"~     This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215~     for the treatment of patients with relapsed or refractory lymphoid malignancies. The target~     population will include patients with histologically confirmed relapsed or refractory~     non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with~     mantle cell lymphoma.~      The phase Ib will be conducted to determine the safety and tolerability of two dosing~     schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be~     accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into~     each cohort will occur by alternation. All patients will take the prescribed dose of~     ACY-1215 orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160~     mg daily (QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily~     (BID). ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be~     administered at least 1 hour after ingestion of food followed by at least 4 ounces of water.~     Patients will be instructed not to ingest food or other oral medication for at least 2 hours~     after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib~     results.~   "
73824|NCT02091050|"~     Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy~     treatment and assess whether tridimensional dosimetry relates more faithfully with the~     occurrence of adverse effects.~   "
73825|NCT02091037|"~     The purpose of this study is to characterize the bacterial strains that colonize children~     with atopic dermatitis.~      The investigators hypothesize that rectal cultures will be more sensitive than anterior~     nares cultures for detecting S. aureus colonization, and that strains of S. aureus~     colonizing patients with atopic dermatitis will be resistant to commonly used topical~     antibiotic ointments.~   "
73826|NCT02091024|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.~   "
73827|NCT02091011|"~     The study is to determine the rate and cause of device replacements at 5 years~     post-implantation. It will assess the battery and device longevity of the Implantable~     Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator~     (CRT-D) devices. It will also validate the device survival information given in Boston~     Scientific's Product Performance Report by comparing the pulse generator (PG) survival~     probability in the study to that presented in the Product Performance Reports (PPR)~   "
73828|NCT02090998|"~     This study will compare a local anesthetic technique that has been used to treat subjects~     suffering from transformed migraines (chronic migraines) versus medical management with~     traditional antidepressant Amitriptyline / Elavil.~      Subjects will be randomized into one of two treatment groups to compare the safety and~     efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block~     with 5% lidocaine gel into the nasopharynx or medical management with traditional~     antidepressants, Elavil, to produce a reduction in the frequency and severity of the~     headache.~      We propose that there will be a difference in the outcomes when comparing the two methods of~     treating transformed migraines and that one research arm will result in more patient~     satisfaction and greater efficacy in the treatment of subjects~   "
73829|NCT02090985|"~     In this study a technique called 'lipomodelling' is being studied to find out if it is~     beneficial around the stoma site in patients who have difficulty with securing their stoma~     bags which may lead to leakage and frequent soiling which we believe reduces quality of~     life.~      Patients with colostomy (stoma formed by bringing large bowel to the surface of the~     abdomen), ileostomy (small bowel) or a urostomy (urinary tract) will be recruited into this~     study.~      Lipomodelling is a technique that is commonly used elsewhere in the body but to our~     knowledge has not been used for this purpose. This study is a pilot study that may lead to~     further research in this area.~      Lipomodelling means taking some of your own fat that lies just beneath the surface of the~     skin and transferring it to another part of your body. The fat is removed by suction~     (liposuction), normally from your thighs or abdomen. In order to use the most important part~     of the fat, it is then put into a machine called a centrifuge. This spins the fat so that it~     splits up into three different sections. The most important section is then separated and~     injected in very small quantities into the required areas around your stoma. It is thought~     to have cells that encourage rejuvenation as well as helping to fill the area injected.~      Peri-stomal means the area around the stoma itself, this includes skin and underlying~     tissue, which will be fat and scar tissue. After any operation there will be scarring that~     takes some time to fully develop. Usually after a year the scar tissue will be fully formed.~     The scar tissue may cause the skin around the stoma to be irregular. This is described as~     contouring of the skin.~      The aim of this study is to see if lipomodelling can improve your quality of life by~     reducing the frequency of changing your stoma bag, reduce leakage and the need for~     extra-stomal appliances to try and help the stoma bag fit to your body securely.~   "
73830|NCT02090972|"~     In this study, the risk of opioid medications on fractures in older adults is investigated.~     Patients from the surgical department with fractures and control patients from the internal~     department of the same hospital are inquired with a standardized questionaire about~     demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed~     using quantitative ultrasound. An impact of recent opioid medications on fractures is~     hypothesised.~   "
74341|NCT02084264|"~     To compare the accuracy and feasibility, curvature correction and clinical outcomes of~     pedicle screw instrumentation with versus without robotic guidance, in pediatric and~     adolescent scoliosis patients~   "
73832|NCT02090946|"~     The experiences of learning from paediatric physiotherapists were explored through~     unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic~     phenomenological study, six parents responsible for a physiotherapy home programme for their~     child were selected through convenience sampling. The purpose of this study was to obtain~     rich and valid information that could be analysed. The phenomenon of their learning~     experiences was formed and explored, its implications discussed and inferences made in light~     of current physiotherapy service delivery.~   "
73833|NCT02090933|"~     This clinical trial studies celecoxib in decreasing the damaging effects of sunburn in~     healthy volunteers. Celecoxib may reduce skin damage by blocking enzymes associated with~     sunburn in healthy volunteers.~   "
73834|NCT02090920|"~     This study looks at the effects of a mother's genes and other characteristics (mother's age,~     baby's age, race, and other diseases) on the ability of nifedipine to end contractions and~     prevent an early delivery. This information will be used to decide what amount of nifedipine~     women need to best treat preterm contractions.~   "
73835|NCT02090907|"~     Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a~     controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to~     estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the~     effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism~     by lab results will be randomized to two groups of treatment with one daily dose of 100 mg~     Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are~     evaluated before and after the study.~   "
73836|NCT02090894|"~     The objective of this study is to examine the ability of dermal rejuvenation therapies to~     protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers~     (including basal cell carcinoma and squamous cell carcinoma) are the most common types of~     malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes~     specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are~     allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much~     greater in elderly over younger individuals. The objective of the present study is to build~     upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of~     a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects.~     Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG~     laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets~     the microvasculature and stimulates collagen production while protecting the epidermis.~     Generally, Laser Genesis is used clinically to improve irregularities in the contour,~     texture, and color of the skin. Laser Genesis is also used to help treat photoaging by~     increasing collagen formation, suggesting that it stimulates fibroblast activity and thus~     possibly increases levels of protective IGF-1.~   "
73837|NCT02090881|"~     Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries~     oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled~     red blood cells cannot travel through small blood vessels as easily as normal red blood~     cells which can lead to blockages. This means that oxygen may be prevented from getting to~     where it is needed. Individuals with sickle cell disease also suffer form abnormality in the~     lining of their blood vessels, which contributes to the damage.~      Damage and blockage can occur in the blood vessels in the brain and means that children with~     sickle cell disease have a significant risk of suffering from strokes. Research has shown~     that transcranial Doppler ultrasonography can be used in this setting to identify children~     at most risk of getting strokes.~      Ultrasound is therefore used in children with sickle cell disease to measure the blood flow~     in the vessels in the brain. This research has formed the basis of the National Health~     Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses~     transcranial Doppler ultrasonography at once a year to screen children with sickle cell~     disease aged 2 to 16.~      Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays,~     is non-invasive and gives good results. However, the results are dependent on the operator.~     This means that the screening service is provided by centres of excellence with experienced~     scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack~     of research comparing the use of portable machines to laboratory-based machines. This is~     important because screening can identify children at high risk of stroke and may be used by~     clinical staff to make a decision about the care of the child.~   "
73838|NCT02090868|"~     This study aims to explore how the introduction of an oral intake screening tool can benefit~     patients requiring noninvasive ventilation. The Quality Care Commission has identified~     nutritional problems in hospital and there is much literature on the importance of nutrition~     when critically ill. Literature is short however concerning the specialized population of~     those requiring noninvasive ventilation and they are a high risk group of suffering from~     malnutrition.~      This study will potentially benefit patients by improving their nutritional care through~     guided assessment and nurse training.~      The study will use mixed methodology, a prospective cohort study and qualitative interviews.~     The prospective cohort study will collect data from patients prior to the tool introduction,~     the control group, and post the tool introduction, the exposure group. This will enable~     comparisons to be made between the exposure and the control groups.~      Nurses will be interviewed in semi structured focus groups prior to tool introduction and~     post to identify themes and sub themes to give a deeper understanding of nutrition in~     hospital and to examine the use of the tool in practice.~      Patients will be eligible if they are over 18 and requiring noninvasive ventilation and~     nurses will be eligible if they work on the high dependency unit. Patients will be visited~     daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14.~     The other daily visits will involve collecting data, which is recorded as part of routine~     care.~      Nurses will undergo 2 focus group interviews and a teaching session. The study will take~     place at St Mary's hospital funded by Imperial College London. The study will be split into~     two periods with a two week gap in between. Each period will last until 22 patient~     participants have been recruited.~   "
73849|NCT02090725|"~     The main purpose for this study is to provide access to 3,4 DAP, a drug which has~     demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic~     Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The~     disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and~     autonomic dysfunction.~   "
73839|NCT02090855|"~     Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and~     imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The~     PET brain images previously obtained in Study GE-067-007 will be interpreted visually in~     randomized by 5 independent readers who are blinded to all other subject information, and~     the images will be classified as abnormal (positive for abnormal neuritic plaque density) or~     normal (negative for abnormal neuritic plaque density). The numbers of images in each~     category will be used to calculate sensitivity and specificity.~   "
73840|NCT02090842|"~     Epidemiological studies demonstrated an inverse associations between cardiovascular events~     and milk and dairy product consumption. Evidence from human intervention studies suggests~     that both whey and casein may be effective in blood pressure-lowering, however there is~     limited data on the impact of milk proteins on vascular function. This research aims to~     compare the potential acute and chronic impacts of the two main milk proteins (whey and~     casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects~     of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory~     status will also be investigated in 'at-risk' individuals.~      This research includes both an acute and chronic intervention study which have been~     independently powered on the appropriate outcome measures. This has generated different~     sample size requirements for the two studies (Actual participants on the acute study: n=27,~     and on the chronic study: n=38).~   "
73841|NCT02090829|"~     : The objective of this study is to determine the tolerability and therapeutic potential of~     oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a~     computer game intervention that is designed to enhance face perception skills. We designate~     two measures as our primary outcomes, based on prior published work with these~     interventions, and we propose a sample based on power analyses from these prior results. A~     second objective of this study is to learn about the breadth of possible positive effects~     that this combination therapy might have for children with ASD. To this end, we include a~     host of other exploratory measures that assess aspects of social motivation and attention,~     social perception, and social cognition. Thus, a second objective is to conduct a signal~     finding study - to gather outcome data on a range of dependent variables that theoretically~     should be related to oxytocin's effects on social processes, but for which there are no~     prior data. The signal finding aspect of this study will provide the preliminary data needed~     to design a more targeted follow up study.~   "
73842|NCT02090816|"~     The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is~     effective in the surgical treatment of simultaneous liver and right lung metastases from~     colorectal cancer~   "
73843|NCT02090803|"~     The purpose of this study is to assess the human herpes virus reactivation 6 post autologous~     stem cells in 196 patients. The aim of our study was to describe the incidence of~     reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic~     role in this target population.~   "
73844|NCT02090790|"~     the aim of this study was to investigate compare the effect of peroperative intravenous~     single dose dexamethasone and the addition of dexamethasone to femoral nerve block on~     postoperative analgesic consumption and patient comfort in unilateral total knee~     arthroplasty patients~   "
73845|NCT02090777|"~     The study will be conducted to examine the feasibility of using a Health Coach for improving~     the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a~     coaching intervention and adherence to glaucoma drops will be monitored using a~     dose-recording device. The dosing data will be analyzed to examine the effect on adherence~     and qualitative interviews at the conclusion of the study will be used to examine which~     elements of the coaching experience were most helpful in the glaucoma patient population.~   "
73846|NCT02090764|"~     This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority~     clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical~     diagnosis of non-bullous or bullous impetigo.~   "
73847|NCT02090751|"~     Age Related Macular Disease (AMD) is easily the leading cause of blindness in older people~     in developed countries. It affects between 30 and 50 million individuals worldwide, with~     around 30% of the over 65's showing early signs of the disease. Severe AMD has a devastating~     impact on the quality of life; it causes extensive visual impairment, making reading~     difficult and driving impossible. Patients lose their independence and become a major burden~     on public health systems.~      Present treatment options are limited. Many new therapies are under development and all will~     need evaluation using a test with high specificity and sensitivity for early AMD. The~     present application will develop such an instrument. The prototype was funded by a previous~     i4i FS (feasibility study ll-FS-0110-14036). The new device measures sensitivity to a dim~     flickering light using the same principle as an established european conformity marked (CE~     marked) instrument. The original method involved lights of different wavelengths and higher~     intensities.~      The instrument in this study assesses night vision, which is selectively damaged in early~     stage AMD. In low lighting, the investigators vision depends on specialized rod~     photoreceptors. Cone photoreceptors, which provide daytime vision, remain normal in the~     early stages of the disease. By the time patients complain of reduced (cone-based) visual~     acuity, they will have had the disease for many years and lost many thousands of~     photoreceptors.~   "
73848|NCT02090738|"~     Helicobacter pylori infection is associated with several gastric diseases, including~     gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO~     classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least~     two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging~     antibiotic resistance to metronidazole or clarithromycin, however, has made successful~     treatment of infection progressively more difficult, with the success rate of standard~     triple therapy now at 70%, well below the 80% required for treatment of infectious diseases.~     Therefore, new treatment regimen is required for successful H. pylori eradication.~      On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H.~     pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated~     that mutation of carbonic anhydrase affected survival of H. pylori. The investigators~     therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with~     standard H. pylori eradication regimen would increase the eradication rate. Here, the~     investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for~     H. pylori eradication.~   "
73850|NCT02090712|"~     At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial~     infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed~     answer at a large metropolis. As a city with more than 11 million inhabitants, the~     distribution of emergency services and public hospitals is also heterogeneous, with scarcity~     in peripheral zones. That heterogeneity of resources also involves the quality of the~     medical care provided. The possibility of a standard care with fast transfer after~     thrombolysis and a tertiary backing system for ECG interpretation, catheterization and~     advanced support could improve this setting.~      In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal~     University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care~     Service arranged a planed system of thrombolysis at peripheral hospitals or at the~     ambulances with immediate transfer to a unique tertiary center for early angiography and~     angioplasty of the culprit artery. The protocol uses recommendations of Brazilian and~     international guidelines, and is the same adopted for the management of ST elevation~     myocardial infarction at Paulista School of Medicine regarding the indications for~     thrombolytic agents, primary and rescue percutaneous transluminal coronary angioplasty~     (PTCA), and pharmacoinvasive therapy.~      The hypothesis of this study is that a network to provide the best care for patients with ST~     elevation myocardial infarction will reduce mortality rates.~      The main purpose of this registry is to provide demographics, metrics and results of this~     experience, maintaining complete records of clinical, laboratory and coronary angiography~     data of all patients allowing short-term outcome analysis of various variables in a large~     population. Additionally, follow-up outcomes will be provide in a sub-group of patients~     keeping their health care at the University or able to be tracked.~      All clinical endpoints of main interest will be assessed as single or composite endpoints~     for evaluation at different time intervals.~   "
73851|NCT02090699|"~     Cardiac failure is the major cause of death in patients with thalassemia and chronic blood~     transfusion-related iron overload. The treatment of thalassemia has been revolutionized over~     the past decade with the implementation of cardiac MRI based assessment of iron overload.~     This has enabled detection of cardiac iron overload prior to symptomatic heart failure and~     now allows for timely therapy which has resulted in a substantial decrease in mortality.~     However, currently implemented MR imaging techniques assess for iron content only and not~     for iron related diffuse fibrosis which play a role in iron related heart failure.~     Histopathologic studies indicate that patients with iron overload have diffuse interstitial~     fibrosis. Quantitative MR techniques have shown that patients with various cardiomyopathies~     demonstrate diffuse myocardial fibrosis and that these changes correlate with changes in~     cardiac function. The investigators propose that quantitative cardiac MRI for assessment of~     diffuse myocardial fibrosis can further improve our ability to detect early damage to the~     myocardium and prevent morbidity and mortality from cardiac iron overload. Detection of~     fibrosis in patients with thalassemia may allow for earlier identification of cardiomyopathy~     when compared to other techniques in clinical use including T2* analysis. Identification of~     fibrosis could affect patient management as it would allow for tailoring of iron chelation~     therapy and may lead to better understanding of the disease processes contributing to heart~     failure and arrhythmia in these patients.~   "
73852|NCT02090686|"~     The purpose of this study is to determine whether pulsatile cupping with a cupping device is~     effective in the treatment of patients with chronic low back pain compared to no cupping or~     to minimal cupping.~   "
73853|NCT02090673|"~     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the~     clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying~     the safety and effectiveness information about Exenatide in general practice.~   "
73854|NCT02090660|"~     This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence~     localization technique with a Laser fluorescence thoracoscope system.~      The primary objective of this study is to prove the validity and safety of our novel~     fluorescent localization method with utilized ICG and novel near infra-red fluorescence~     videoscope system.~   "
73855|NCT02090647|"~     The objective of the study was to assess the aesthetic outcome of different abutments~     materials and shapes on dental implants .~      A set of parameters, including assessments of the mucosa and periodontal tissue , soft~     tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of~     the aesthetic of implant-prosthesis rehabilitations.~   "
73856|NCT02090634|"~     Adherence to combination antiretroviral therapy (ART) is critical for successful HIV viral~     suppression. Nonadherence to ART poses several potentially serious health consequences,~     including higher viral loads, faster progression to AIDS, and a heightened risk of viral~     mutations, treatment resistance and HIV transmission.~      The prevalence of serious mental illness (SMI) conditions, including bipolar disorder (BD),~     is elevated among HIV-infected populations and is associated with poor ART adherence.~     HIV-infected individuals with co-occurring BD (HIV+/BD+), when compared to demographically~     similar HIV+/BD- persons, demonstrated poorer ART and psychotropic medication adherence and~     were twice as likely to be non adherent to their ART regimen using a ≥ 90% cutoff score.~     HIV+/BD+ individuals are particularly at-risk for medication non adherence, and there is a~     critical need to develop interventions to improve adherence in this population.~      Poor psychotropic medication adherence is also common among people with SMI - it has been~     estimated that 40% of those with BD do not take their mood stabilizer as prescribed. Among~     persons with BD, nonadherence to psychotropic medications can lead to greater risk for manic~     and depressive episodes, decreased quality of life, suicide attempts, and hospitalization.~      The utilization of mobile health (i.e., mHealth) technologies to improve everyday~     functioning is growing. mHealth interventions capitalize on technology already incorporated~     into most people's daily lives (e.g., cell phones) to assist people with behavior~     modification and disease self-management. Text messaging, in particular, may support daily~     ART adherence by delivering reminders at precise times to match an individuals' dosing~     schedule. The initial evidence for using text messaging to improve ART medication adherence~     has been compelling. Researchers and clinicians have also started employing technology-based~     approaches to improve treatment for individuals with BD.~      Taken together, a distinct need for RCTs utilizing text messaging to improve medication~     adherence within an at-risk HIV population is warranted. Individualized Texting for~     Adherence Building (iTAB) is one such intervention.~      The investigators propose an intervention development study designed to address these~     potential mechanisms of nonadherence with the following Specific Aims: 1) To further develop~     and refine a personalized, automated, real-time, mobile phone, text messaging intervention~     (iTAB) designed to improve adherence to ART and psychotropic medications among HIV+/BD+~     persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus~     text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the~     improvement of objectively measured medication adherence among HIV+/BD+ persons; and 3) To~     examine predictors of within-person trajectories of nonadherence using the longitudinal data~     collected over the study. In order to realize these aims, the investigators will leverage~     the infrastructure of two unique UCSD resources increasing likelihood of study success,~     impact, and innovation: 1) the HIV Neurobehavioral Research Program (HNRP), which~     encompasses multiple NIH-funded studies that focus on the effects of HIV infection, and 2)~     the California Institute for Telecommunications and Information Technology (Calit2), which~     conducts research on state-of-the-art wireless means of health promotion. Initially, the~     investigators will refine the iTAB intervention to ensure that it is user-centered and~     tailored to the needs of HIV+/BD+ persons via focus groups and rapid prototyping. Once~     refined, the proposed iTAB intervention will use text messages that are automated, scalable,~     personalized, interactive, flexible, and motivating. The investigators will assess the~     acceptability and effectiveness of iTAB in improving objectively measured adherence (i.e.,~     MEMS caps) over a 4-week period via a pilot RCT with 25 HIV+/BD+ assigned to the iTAB~     intervention and 25 HIV+/BD+ assigned to a psychoeducational control. Predictors of~     nonadherence including neuropsychological impairment, and mood will be examined to determine~     whether iTAB is better able to compensate for these factors associated with nonadherence as~     compared to CTRL. Further refinement to the iTAB intervention will be made in order to~     pursue a large-scale R01 using the investigators tailored intervention.~   "
73857|NCT02090621|"~     The purpose of this study is to determine the safety of photopheresis for prophylaxis of~     allograft rejection in patients who are being withdrawal immunosuppression after liver~     transplantation.~   "
73858|NCT02090608|"~     Proteinuria is the predominant risk factor for renal disease progression in Fabry disease~     (FD). When urine protein excretion is controlled to <0.50 g/24 hr, the rate loss of~     glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme~     replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended~     that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy.~     Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of~     intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is~     to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr~     persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.~   "
73859|NCT02090595|"~     Children who have parents with bipolar disorder are at risk for developing anxiety~     disorders.~   "
73860|NCT02090582|"~     The purpose of this study is to test the effect of the gynecologic oncologists with~     palliative care specialist collaboration (GO-PC) intervention on patient quality of life.~   "
73861|NCT02090569|"~     High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography~     During Brain Surgery (ULYS)~   "
73862|NCT02090556|"~     The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months~     in routine clinical practice, in rheumatoid arthritis patients, in each country involved in~     the study. The purpose of the UK substudy is to explore whether integrating self-assessment~     into routine care could maintain tight control (of inflammation/disease activity) and at~     potentially lower cost resulting in improved health outcomes and cost-effectiveness.~   "
73863|NCT02090543|"~     According to recent guidelines, long-term anticoagulation is recommended for patients with~     atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K~     antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment~     options for AF patients with additional risk factors for stroke. Currently there are only~     limited information to what extend AF patients prefer one or the other treatment option~     based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also~     unknown which of the characteristics influences patient preference most and how this relates~     to a neutral comparator. Furthermore, an additional unknown factor is also how patient~     evaluate their current treatment and if this leads to differences among treatment with VKAs~     and rivaroxaban.~   "
73867|NCT02090491|"~     Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders~     characterized by qualitative impairments in socialization, communication, and circumscribed~     interests, including stereotypical behavior patterns and behavioral rigidity to changes in~     routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive~     developmental disorder of childhood, currently estimated to affect 1 in 88 school age~     children (Baio, 2012). ASD typically manifests in infancy and persist throughout the~     lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions~     and medications can enhance developmental outcomes. ASD has a profound impact on families~     and often result in enormous emotional and financial costs. Recent estimates suggest that~     societal costs in the US to care for all individuals diagnosed each year over their lifetime~     approaches $35 billion (Ganz, 2007).~      Janssen Research & Development is building a comprehensive digital platform (MENTIS) to~     optimize and enhance development of novel medicines and track outcomes in individuals with~     ASD. The MENTIS platform contains several core components, including: (1) An electronic~     personal healthcare record, designed specifically for individuals with ASD and their~     caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and~     physical activity biosensors designed to objectively assess outcomes important in ASD, and;~     (3) A de-identified research data warehouse with analytic tools to better measure outcomes,~     assist with sub-population identification, and identify algorithms for diagnosis and~     treatment response detection.~      The MENTIS platform is currently being designed, developed, and prepared for testing. During~     this process it is highly desirable to conduct feasibility and usability research with a~     sample of the target population to identify important system components and features,~     optimize design, and reduce redundancy in software development and research time. The rapid~     pilot study described herein is proposed to gather incipient feedback on select MENTIS~     system components and features from stakeholders who support individuals with ASD in a~     clinical setting. This pilot research will help evaluate both how well current MENTIS system~     features work in an applied setting and inform future directions for MENTIS platform~     development.~   "
73868|NCT02090478|"~     The purpose of the study is to determine how reducing the amount of simple sugars in the~     diet affects sweet taste perception. Healthy adult subjects will be assigned to either~     follow their usual diet, or to replace sugar calories with fats or starch.~      The investigators hypothesize that eating less sugar will:~        1. cause foods and drinks with a given amount of sugar to taste sweeter~        2. cause people to prefer lower levels of sugar in foods and drinks~   "
73869|NCT02090465|"~     Assessment of treatment success and quality of life in patients with actinic keratoses under~     therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.~   "
73870|NCT02090452|"~     The purpose of this study is to examine if real time transmission of vital signs, ECG and~     chat communication between the prehospital ambulances and the emergency department has an~     effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to~     treatment and time to diagnostics~   "
73871|NCT02090439|"~     In the diagnosis of renal colic gallstone , in addition to clinical and biological factors,~     it is a key : medical imaging. Currently , the French recommendations require at least a~     couple of Abdomen radiography Without Preparation lying face (ASP ) associated with~     abdominal ultrasound . The abdominopelvic CT scan without injection of contrast is the~     examination of choice.~      Current recommendations in the management of gallstone colic simply based on the joint use~     of analgesics , anti inflammatory drugs and control of water intake .~      The mechanism of analgesic action of this treatment is a decrease in the pressure in the~     cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage~     of urine . )~      The expulsive medical therapy remains under evaluation. The French Association of Urology~     does not recommend at this time for lack of evidence deemed sufficient.~      For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha~     blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended~     (grade 1A) . However, there are less formal studies of their effectiveness .~      Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy~     for pelvic stones 4 to 10mm .~   "
73872|NCT02090426|"~     This trial investigates the value created by the highly innovative Camden Coalition of~     Healthcare Providers' Care Management Program: Link2Care. The program targets~     super-utilizers of the health care system - specifically adults with 2 or more~     hospitalizations in the last six months 2 or more chronic conditions, and 5 or more~     outpatient medications - with intensive case management services. In particular, a team of~     nurses, social workers, community health workers and health coaches, supported by real-time~     data of healthcare utilization, perform home visits, accompany patients to doctor visits,~     and help patients enroll in social-service programs. This approach aims to improve the~     self-sufficiency of patients in navigating the healthcare and social-service systems and has~     the potential to reduce healthcare costs and improve patient health.~   "
73873|NCT02090413|"~     The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin~     (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF)~     administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF~     administration reduces the incidence and/or severity of flushing events in subjects with~     relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with~     DMF in the clinical practice setting.~      Secondary objectives of this study are: to evaluate the safety and tolerability of DMF~     administered with and without enteric-coated ASA in the clinical practice setting; to~     evaluate the impact of DMF administration on quality of life as measured by the Short Form~     36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L)~     questionnaires.~   "
73874|NCT02090400|"~     The aim of this study is see the changes in bone mineral density after discontinuation or~     stop the use of bisphosphonates and make the switch to bazedoxifene).~   "
73875|NCT02090387|"~     The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the~     lean body mass (LBM) loss that occurs after bed rest.~   "
73881|NCT02090309|"~     The investigators hypothesis is that low (or low relatively to the situation) cortisol~     levels might be a causative factor of whiplash injury or post traumatic stress disorder~     following road accidents. In this study the investigators enroll patients who sustained a~     road accident. From all patients a blood sample will be withdrawn to measure cortisol~     concentrations. Than, the patients will be divided into 2 groups: the study group will~     receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid~     used routinely for many years). The control group will receive a same volume of normal~     saline which would be used as a placebo treatment. The investigators assume that patients~     with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or~     post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these~     untoward sequelas of trauma.~   "
80557|NCT02002988|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of~     left atrium for preventing drug-resistant paroxysmal atrial fibrillation.~   "
73876|NCT02090374|"~     The investigators propose the development of a range of nasal spray challenge models to~     study the way the nose can respond to different types of nasal challenge that elicit~     different forms of inflammation.~      The investigators will carry out nasal challenge with bacterial and viral components and~     allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli~     of the immune system, causing various types of inflammation. Samples will be taken by~     blotting the nostril surface and by scraping off tiny surface samples.~      The nose will be sprayed with a substance that is a single part of a bacteria or virus, or~     with an allergen. The material delivered by nasal spray is of high purity and is sterile,~     containing no live bacteria or viruses. The nasal spray substance contains molecular~     patterns that are recognised as foreign by the immune system, and at the right dose should~     stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive~     methods of sampling using absorptive strips. These strips look and feel like tissue paper,~     and are applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples~     are taken from inside the nose, using a small disposable sterile plastic probe that has a~     tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken~     of a range of molecules and cells that protect against infections and help the immune~     response.~      By spraying the nose with a challenge agent in this manner, the nasal immune response can be~     assessed, which can help us better understand how the human immune system cells and~     molecules respond to bacteria and viruses. In the future, this may allow the testing of new~     drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal~     challenge.~   "
73877|NCT02090361|"~     In reconstructive surgery , most losses of cutaneous substance require the use of a thin~     skin graft . This technique allows epidermization of the defect by applying a thin layer of~     autologous epidermis. It does not reconstitute the injured skin. Transplants cause~     retractile scars, adherent to the deep plan, that may require revision surgery . Since a~     decade , dermal matrices are mainly used in burned skin centers . The collagen -elastin~     matrix has the advantage to set up in the same operation that the skin graft and contain~     elastic fibers , two assets which improve the results of skin grafting.~      Objective:~      Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin~     Foldability, at day 360.~      Methodology:~      This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille)~      Conduct of the study :~      The transplant will be performed according to the protocol defined between inter -region~     surgeons. The implementation of the dermal matrix will be in the same surgical technique as~     thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time .~      Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to~     the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a~     cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH).~      To achieve the main objective, it is planned to compare the ratio between Uf graft site and~     the opposite healthy site between two groups: skin + matrix graft , or skin graft only.~     Thus, the Wilcoxon test for independent samples will be used to settle bilateral formulation~     between the null hypothesis ( there is no difference between the two groups ) and the~     alternative hypothesis ( there is a difference between the two groups ) . In determining the~     overall risk of first species to 5% and the power of this test to detect the 90% expected~     under the alternative hypothesis difference should be the main criterion for evaluating at~     least 59 patients in each group so 118 patients total.~      Prospect If the contribution of a dermal matrix in loss of skin substances improves skin~     pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the~     dermal matrix may be proposed as a complementary treatment in these indications.~   "
73878|NCT02090348|"~     The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken~     over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured~     by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in~     participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of~     this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue~     Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess~     the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work~     Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]),~     health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck~     Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS])~     at 6 and 12 months in participants receiving DMF; To examine whether an association exists~     between fatigue and baseline demographics (e.g., age and sex) and disease characteristics~     (e.g., disease duration, baseline disease activity, treatment history, expanded disability~     status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication~     use.~   "
73879|NCT02090335|"~     The goal of this project, which has not changed, is to improve the health and fitness of~     persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles.~     Participants are randomly assigned to the In SHAPE program or Health Club Membership and~     Education only.~      The three specific aims of this study are to:~        1. To compare the treatment groups with respect to improvement in physical fitness~          outcomes, including: (a) health behaviors (engagement in exercise and diet changes);~          and (b) indicators of physical fitness.~        2. To compare the treatment groups with respect to improvements in mental health outcomes,~          including negative symptoms, depression, and self-efficacy.~        3. To explore differences in the treatment groups with respect to psychosocial~          functioning, health status, and acute service use, and the effects of selected~          demographic, clinical, and health behavior variables on primary outcomes.~   "
73880|NCT02090322|"~     The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby,~     it's characterized for proliferation of vascular tissue that grow in the limit between the~     vascular retina and the avascular retina. The altered regulation of Vascular Endothelial~     Grow Factor (VEGF) has been proposed as one of the principal factor in the pathogenesis of~     the ROP.~      The ROP is classified for: location (zones I,II,III), extension (hours 1 to 12) and for~     stages (1,2,3,4a,4b,5) and features of the vessels (normal, pre-plus and plus).~      With the diagnosis of ROP type 1(ROP zone I any stage with plus, zone I stage 3 without~     plus, zone II stage 2 y 3 with plus) the treatment is begun and ROP type 2 is maintained in~     observation.~      The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one~     of the principal factors in the pathogenesis of ROP.~   "
73893|NCT02090153|"~     The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin~     (1 week on and 1 week off) as first-line treatment for patients with metastatic and~     recurrent gastric cancer.~   "
74016|NCT02088541|"~     This is a randomized, multicenter, open-label, Phase 2 study of the SINE Selinexor given~     orally versus specified investigator choices (one of three potential salvage therapies).~     Patients age ≥ 60 years with relapsed/refractory AML of any type except for AML M3, after~     one prior therapy only, who have never undergone and who are not currently eligible for stem~     cell transplantation and are currently deemed unfit for intensive chemotherapy.~   "
73882|NCT02090296|"~     Sickle cell anemia (SCA) patients experience organ damage that begins at an early age and~     results in significant morbidity and early mortality. Although all SCA patients share the~     same genetic mutation, the clinical complications are highly variable with some patients~     experiencing frequent and severe complications, while others have few serious complications.~     If SCA severity could be predicted early in life, those patients at greatest risk for~     complications could receive treatment prior to the onset of organ damage. No general SCA~     severity predictor or one that can be informative early in life exists. The investigators~     preliminary research has identified the absolute reticulocyte count (ARC) as a potential~     early predictive risk marker for SCA complications in pediatric patients. A higher ARC~     between ages 2 and 6 months of age is associated with an increased risk of hospitalization~     in the first 3 years of life; the mean ARC for the 36 patients who were hospitalized for SCA~     complications was significantly higher than that of the remaining 23 in those who were not~     hospitalized. Moreover, total hospitalizations were nearly three times higher by age 2 years~     in those infants who had an ARC of > 200 than for those infants whose ARC was <200. The~     proposed study will determine if ARC can be used as a risk-stratifier in asymptomatic~     infants with SCA and ascertain its value in targeting hydroxyurea therapy to those infants~     at highest risk of SCA sequelae.~   "
73883|NCT02090283|"~     The purpose of this study is to assess the continued safety of topical use of SD-101 cream~     (6%) in subjects with Epidermolysis Bullosa~      Funding-Source-FDA OOPD~   "
73884|NCT02090270|"~     The purpose of this study is to prospectively examine the relation between ischemic stroke~     and hair cortisol concentration. The investigators hypothesize that patients with ischemic~     stroke have higher levels of hair cortisol compared to controls.~   "
73885|NCT02090257|"~     The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and~     test an intervention (i.e., a standardized, tailored transition program focused on enhancing~     adherence) to improve outcomes for emerging adults who underwent heart transplantation as~     children and transfer to adult care.~   "
73886|NCT02090244|"~     Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies.~     There are so far only three published papers concerning humans. Postero-lateral fusions have~     shown a healing rate of less than 50% after bone. The purpose of this study is to determine~     if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal~     stenosis surgery.~   "
73887|NCT02090231|"~     Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually~     associated with high levels of morbidity, mortality, and financial cost. In recent years,~     repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate~     poststroke dysphagia. However, most researches were preliminary studies in the past. The~     present study aims to investigate the immediate and long-term efficacy of high frequency~     rTMS on chronic dysphagic patients.~   "
73888|NCT02090218|"~     The main objective of this trial is to compare the effectiveness of a newer supraglottic~     airway method (the i-Gel), compared to current airway management practice in out-of-hospital~     cardiac arrests treated by Norwegian ambulance services.~   "
73889|NCT02090205|"~     Background There is no unanimous opinion about a lung-protective strategy in cardiac~     surgery. Small randomized clinical and animals trials suggest that ventilation during~     cardio-pulmonary bypass (CPB) could be protective on the lungs. This evidence is based on~     surrogate end-points and most of studies are limited to elective coronary surgery. According~     to the available data, an optimal strategy of lung protection during CPB cannot be~     recommended. The purpose of the CPBVENT study is to investigate the effectiveness of~     different ventilation strategies during CPB on post-operative pulmonary complications.~      Trial design The CPBVENT study will be a single-blind, multicenter, randomized controlled~     trial. We are going to enroll 780 patients undergoing elective cardiac surgery with planned~     use of CPB, aortic cross-clamping and two lung ventilation. Patients will be randomized into~     three treatment groups: 1) no ventilation during CPB; 2) continuous positive airway pressure~     (CPAP) with positive end-expiratory pressure (PEEP) of 5 cmH2O during CPB; 3) ventilation~     with 5 acts/minute with tidal volume of 2-3 ml/Kg and a PEEP of 3-5 cmH2O during CPB. The~     primary end-point will be the incidence of a PaO2/FiO2 ratio <200 until the time of~     discharge from the ICU. The secondary end-points will be the incidence of post-operative~     pulmonary complications and 30-days mortality. Patients will be followed-up to 12 months~     after the date of randomization.~      Summary The CPBVENT Trial will determine whether different ventilation strategies during CPB~     will improve pulmonary outcome in patients undergoing cardiac surgery.~   "
73890|NCT02090192|"~     Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on~     the lower extremity blood flow, mobility function, balance, muscle strength, bone density,~     and general health status, and its feasibility as an intervention in frail elderly patients.~      Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried~     Frailty Criteria.~      Interventions: All eligible subjects were randomly assigned to 4 groups:~      (1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive~     resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+~     PRT group: Subjects received the whole-body vibration and progressive resistance training;~     (4) Control group: Subjects received no intervention/training. The periods of intervention~     are 12 weeks.~      Main measures: The lower extremities blood flow (the diameters and red blood cell velocity~     of the common femoral artery), timed up and go test, 30-second chair stand test, five times~     sit to stand test, lower extremities muscle strength, balance function, balance confidence,~     bone density, and general health status was assessed at the beginning of the study, at~     instant, 12 weeks and 24 month after the intervention.~      Study hypothesis: Whole-body vibration exercise is a safe and effective method that can~     improve the lower extremity blood flow, mobility function, balance, muscle strength, bone~     density, and general health status in the frail elderly.~   "
73891|NCT02090179|"~     The purpose of the study is to characterize structural abnormalities in the brain and the~     integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS~     IIIB).~   "
73892|NCT02090166|"~     Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity~     Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung~     cancer.~      The study population will include a total of 950 participants, patients with lung cancer~     before any treatment, and healthy and COPD patients as a control group.~   "
73894|NCT02090140|"~     The purpose of this study is to compare two biologic methods for the treatment of articular~     cartilage defects in the knee. The first method, microfracture, is the standard of care and~     is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage~     loss. The second method is the application of adipose-derived stem cells (ADSCs) to the~     defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more~     specific progenitor cells to the site of injury, resulting in better regeneration and~     integration of articular cartilage at the site of a defect as compared to the microfracture~     method.~   "
73895|NCT02090127|"~     Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient~   "
73896|NCT02090114|"~     Single-arm, single site, open label study of the effects of parenteral testosterone followed~     by enzalutamide or abiraterone in men with metastatic CRPC who previously progressed on~     either of these agents. The study will enroll two cohorts of patients: men with metastatic~     CRPC who have progressed on enzalutamide (Cohort A); and men with metastatic CRPC who have~     progressed on abiraterone acetate (Cohort B).~   "
73897|NCT02090101|"~     The metastatic colon cancer is a major public health problem despite advances in~     chemotherapy; few new drugs are in development for the treatment of this pathology.~      Many studies have shown that human colon cancer is a tumor that is recognized by the immune~     system and the presence of lymphocytic infiltrates in the tumor bed is associated with a~     better prognosis. Conversely, the effect of chemotherapy on the immune response is little~     studied.~      Recently the importance of myeloid suppressor cells (MDSC) in the development of colon~     cancer and the effect of 5- fluorouracil on this cell population has been highlighted. An~     accumulation of these cells in the blood and lymphoid organs during tumor progression is~     observed. Moreover, it has been established that the death of MDSC induced by 5-fluorouracil~     induces activation of caspase -1 and IL-1beta by these MDSC.~      These events promote the polarization of CD4 T cells in intratumoral Th17 lymphocytes. The~     IL- 17 produced by these cells exerts a pro-angiogenic effect in inducing proliferation of~     endothelial cells expressing and thus limits the effect of 5- fluorouracil endoglin.~      In humans, it has also been observed that chemotherapy using 5- fluorouracil and in~     particular LV5FU2 association +/- bevacizumab induces rapid death of blood MDSC as well as~     activation of caspase 1 in these cells. Thus, production of IL - 1 is detected in the serum~     of patients after 24 hours of the administration of 5-fluorouracil.~      Chronic inflammation and the production of interleukin- 1 can alter the effectiveness of~     anti -tumor immune responses and facilitate angiogenesis. Many preclinical data suggest a~     role of anti -tumor inhibition of IL- 1beta, but the effect of a combination of chemotherapy~     and an inhibitor of IL - 1beta has not yet been tested in human.~      Anakinra is a drug used in humans for many years to treat signs and symptoms of rheumatoid~     arthritis. In combination with methotrexate, in patients whose response to methotrexate~     alone is not satisfactory it had shown interesting results. The dose used clinically is 100~     mg per day which is the dose that is proposed to be tested in this study.~      In this context it should be remembered that methotrexate is a chemotherapeutic agent from~     the class of antimetabolites such as 5- fluorouracil.~      RCP of this drug indicate that in studies originator toxicity was similar between the~     control arm and anakinra arm with an increase in serious infections (1.8 % vs 0.7 %) and an~     increased incidence of neutropenia (2.5 % neutropenia > grade = 1). The main toxicity~     observed is a painful inflammatory reaction at the injection site in 70 % of patients The~     investigators believe that this project could permit to validate in man preclinical~     observations showing an anti-tumor potential for combination anakinra and 5 fluorouracil.~   "
73898|NCT02090088|"~     US study to estimate the prevalence at birth of major birth defects (ie, those that cause~     significant functional or cosmetic impairment, require surgery, or are life-limiting) in~     children born to mothers who have received Nplate® therapy at any time during the pregnancy.~   "
73899|NCT02090075|"~     Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for~     irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however,~     that these agents also cause calcification of vessels (hardening of the vessels). Vascular~     calcification is one of the recently revealed side-effects of warfarin therapy. We will be~     randomizing 66 patients to either take warfarin or a new blood thinner that works without~     affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram~     (non-invasive angiogram) at the beginning of the study, and then be followed for one year~     with quarterly visits including blood tests and given either warfarin or vitamin K. After~     one year, they will undergo another CT angiogram and examination and blood tests and the~     effect of apixaban and warfarin are tested to look at plaque and changes over time. Patients~     will be consented in a private room and the risks and benefits will be explained. The risks~     include the CT angiogram and the possibility of either remaining on warfarin therapy for~     another year (standard of care) or taking a medicine that doesn't require monitoring~     (apixaban) for one year. The CT angiograms will require some contrast and some radiation~     dose, which will be minimized as much as possible. A cardiologist will be present during~     each CT angiogram to minimize risk and ensure patient safety.~   "
73900|NCT02090062|"~     Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens~     become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our~     study aims to determine the difference in H. pylori infection rate of EGC patients before~     and after ER , and discuss the causes leading to the difference, which can provide~     references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's~     recurrence rate.~   "
73901|NCT02090049|"~     The aim of this study is to evaluate the appetite rating of a soft bread with a high content~     of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial~     levels of glucose, insulin and gastrointestinal hormones involved in appetite control and~     insulin secretion in healthy adult volunteers.~   "
73902|NCT02090036|"~     The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine~     added to standard artemether/lumefantrine treatment for the clearance of Plasmodium~     falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above~     regardless of their G6PD status.~   "
73903|NCT02090023|"~     The purpose of this study is to explore long-term prognosis and to identify the predictors~     in Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the~     database of National Taiwan University Hospital (NTUH) sleep center is planed to determine~     the effects of different treatments on long-term prognosis.~   "
73904|NCT02090010|"~     Seldinger technique is a minimally invasive technique in which the practitioner accesses the~     target vessel with a small bore needle, then dilates to the size required for the catheter.~     Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use~     needle that is covered with guiding sheath.~      Both technique is widely used in central venous catheterization, however, few researches~     have been investigated to compare success rate or complications of both methods.~   "
73905|NCT02089997|"~     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate~     tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as~     to examine the status of treatment compliance - i.e., whether sodium risedronate tablets~     are taken properly in accordance with the prescribed once-monthly regimen~   "
73909|NCT02089945|"~     Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede~     blood delivery and is associated with poor quality of life and death. In the elderly with~     considerable medical burden, a relatively new non-invasive valve replacement technique~     called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart~     surgery. However, long term changes in cognition after TAVI remain unclear and previous~     studies have suggested an increased risk of cognitive decline in patients following the~     surgical procedure. In this pilot study, the investigators will characterize changes in~     cognition, physical capacity, overall quality of life and neuropsychiatric symptoms~     (depression and apathy) over 6 months after TAVI.~   "
73910|NCT02089932|"~     The duration of sensory block after single dose of long acting local anesthetics is not~     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as~     clonidine have been shown to increase the duration of peripheral nerve block.~     Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To~     the best of our knowledge, the use of Dexmedetomidine in different dose levels as adjuvant~     to local anesthetic was not previously reported for femoral nerve block.~   "
73911|NCT02089919|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor~     immunity.~   "
73912|NCT02089906|"~     This study is aiming to understand the prevalence and risk factors related to malnutrition~     and sarcopenia in Chinese elderly.~   "
73913|NCT02089893|"~     The purpose of this study is to analyze the retinal arteries, to investigate the incidence,~     number, types, distribution and localization of cilioretinal arteries in the Hungarian~     Caucasian population.~   "
73914|NCT02089880|"~     The study will specifically evaluate the potential of the C-Brace to improve the functional~     mobility and quality of life in individuals with lower extremity impairments due to~     neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance~     control orthosis.~   "
73915|NCT02089867|"~     The purpose of this study is to determine the effect of plant sterols associated with~     ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy~   "
73916|NCT02089854|"~     The study is a prospective multi-center randomized control clinical trial which is sponsored~     by the researchers. The purpose of this study is to determine the effectiveness of adjuvant~     endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast~     cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who~     had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1)~     enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients)~     /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after~     adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at~     least five years. The disease free survival(DFS) and overall survival(OS) between endocrine~     group and observation group will be compared to evaluate the effectiveness.~   "
73917|NCT02089841|"~     Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated~     malaria since 2007. Nonetheless, a report of increased proportion of patients with~     parasitaemia on day 1 following treatment with artemisinin based combination therapies has~     emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in~     South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to~     assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria~     among children after five years of wide scale use of the drug in Tanzania.~   "
73918|NCT02089828|"~     To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral~     blood mononuclear cells in treatment of critical limb ischemia~   "
73919|NCT02089815|"~     Prior studies have shown multifaceted falls prevention program with home-based exercise~     reduced falls significantly in the community setting. The Otago exercise program has been~     tested in four separated controlled trials of community living people in New Zealand. Falls~     were the main outcome in each trail and were defined as unintentionally coming to rest on~     the ground, floor or other lower level. Not only this combination strengthening and balance~     training exercise could reduce fall but also could benefit in cost-effectiveness for fall~     prevention and decrease mortality in those 80 and older. However the limitation of Otago~     exercise program is that the program was needed to be trained by skill nurses or physical~     therapists. There are 17 steps levels to adhere the program. As some studies have shown that~     fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical~     staffs are continued the problem in the community. Therefore to establish fall prevention~     guideline that will be suitable and translated into the real setting, this study is aimed to~     test the effectiveness of simple program home-based exercise comparing to non-simple program~     home based exercise in preventing fall and improve muscle strength and balance dysfunction~     in older people with mild to moderate balance dysfunction. The method is the randomized~     controlled trails.~   "
73920|NCT02089802|"~     Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic~     Drug Monitoring followed by Individual Dose Escalation.~   "
73996|NCT02088801|"~     In this second phase of the multicenter study the investigators are going to evaluate the~     use of three different videolaryngoscopes in patients undergoing elective surgery requiring~     general anesthesia with intubation. The investigators are hypothesizing that these three~     videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases~     using a difficult airway simulation with extrication collars. As the gold standard, a~     standard Macintosh blade is being used for comparison.~      The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480~     patients.~   "
73921|NCT02089789|"~     Background:~      - Proteins, fats, and other molecules are the body s building blocks. Many of these~     molecules must have sugars, or chains of sugars, attached to work properly. People with~     congenital disorders of glycosylation (CDGs) cannot attach these sugars or sugar chains~     properly. A child or adult with a CDG can have symptoms in different parts of the body,~     including brain, nerves, muscles, liver, and immune system. Researchers want to learn more~     about these diseases to understand better what is causing the problems.~      Objective:~      - To learn more about CDGs.~      Eligibility:~      - People age 1-80 with CDG or suspected to have a CDG.~      Design:~        -  CDG participants will stay in the hospital 3-5 days. They will have:~        -  Medical history and physical exam. They will answer questions about their CDG.~        -  Blood taken several times. Their skin will be numbed, then a needle will take blood~          from an arm vein.~        -  Samples taken of their skin, urine, and maybe stool and spinal fluid.~        -  Photos taken of their whole body. They can wear underwear and cover their eyes.~        -  Brain MRI. They will lie on a table that slides in and out of a metal cylinder. The~          scanner makes loud knocking noises so they can wear earplugs.~        -  Abdomen ultrasound. Sound waves take images of the body from the outside.~        -  Hand/wrist X-rays for young patients. They may have a full-body X-ray.~        -  DEXA bone density scan. Participants will lie on a table under a scanner.~        -  Echocardiogram and electrocardiogram for heart activity. Pads are stuck on the skin and~          the electrical activity of the heart is recorded.~        -  Tests of hearing, thinking, motor skills, and speech.~        -  Children participants may have tests done under sedation if it will benefit them~          directly.~        -  CDG participants may have other procedures during their visit. They may have follow-up~          visits every year.~   "
73922|NCT02089776|"~     Background:~      - People can learn to use feedback about brain activity to change that activity. Researchers~     want to see if people who have had a stroke can change their brain activity by practice and~     thought with feedback, and if that improves motor control. They will study brain activity in~     people who have and have not had strokes.~      Objectives:~      - To see if people with stroke can change their brain activity and improve motor control by~     practice and thought.~      Eligibility:~        -  Adults 18 80 years old who have had a stroke.~        -  Healthy volunteers 18 80 years old.~      Design:~        -  Participants will be screened with a medical history, MRI, and physical exam. For MRI,~          a magnetic field and radio waves take pictures of the brain. Participants lie on a~          table that slides in and out of a cylinder. They will be in the scanner less than 2~          hours, lying still for up to 15 minutes at a time. The scanner makes loud noises.~          Participants will get earplugs.~        -  Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24~          weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and~          simple motor tests. Stroke participants may take additional motor tests, including~          transcranial magnetic stimulation (TMS).~        -  fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove~          with small wires in it may be used to monitor hand movements. Heart rate and breathing~          may also be monitored. Participants may be monitored by video and asked to perform~          tasks.~        -  TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic~          pulse that stimulates the brain. Participants may be asked to perform simple actions.~          Finger or hand movements may be recorded.~   "
73923|NCT02089763|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-BCT-100 as the~     second-line therapy following sorafenib in advanced HCC patients. Another objective of the~     study is to explore whether the expression of OTC and ASS are predictive biomarkers for drug~     response and prognosis.~   "
73924|NCT02089750|"~     The goal of this randomized clinical study is to assess pain and dysfunction in 225~     volunteer subjects who have chronic low back pain.~      The hypothesis of this study is that custom-made shoe will improve patients' low back pain~     and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will~     further improve patients' low back pain and dysfunction while maintaining that improvement~     during the one year study follow-up period.~      Specific Aims:~        1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and~          dysfunction (Oswestry Disability Index) in patients with chronic low back pain after~          six weeks of custom-made shoe orthotic use with or without chiropractic care as~          compared to no care.~        2. To determine the changes in perceived pain levels and dysfunction in patients with~          chronic low back pain after twelve weeks of custom-made shoe orthotic use.~        3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12~          months following the 12 week treatment period.~   "
73925|NCT02089737|"~     The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be~     studied.~      Specifically, information will be collected on the following as events of interest: skin~     disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and~     cardiac disorders.~   "
73926|NCT02089724|"~     Erdheim-Chester disease (ECD) is a rare non-Langerhans cell histiocytosis. Diagnosis of ECD~     is based on clinical symptoms, imaging and histology with infiltration of tissues by foamy~     CD68 positive CD1a negative histiocytes.~      Because half of the ECD patients carry a BRAFV600E mutation, we recently proposed~     vemurafenib, an inhibitor of mutant BRAF, as a possible targeted therapy. We have treated~     more than10 patients with refractory ECD with life-threatening manifestations associated~     with the BRAFV600E mutation and observed a short and long term efficacy.~      However, vemurafenib may have several side effects and long term administration of this drug~     has not been evaluated. In other diseases such as melanoma, duration of administration is~     usually shorter, due to bad prognosis of the disease and progression despite treatment.~      As in long-term follow-up, ECD patients with vemurafenib seem to have a stable disease, we~     want to evaluate the possibility of treatment interruption as this is what we do in our~     current practice. Other BRAF inhibitors, such as dabrafenib, have recently been proposed for~     treating BRAF mutated histiocytoses. Other BRAF inhibitor interruption treatment should also~     be prospectively evaluated.~   "
73927|NCT02089711|"~     This study is being initiated to create a normal database including measures of optic nerve~     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg~     Spectralis OCT device. The range will be determined for each structural parameter across~     normal eyes in Japanese subjects, and the measurements stratified according to age.~   "
73928|NCT02089698|"~     To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional~     phacoemulsification using the bevel-down technique.~   "
73929|NCT02089685|"~     This study is being done to analyze the safety, tolerability, and efficacy of treatment for~     advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of~     pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab~     (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated~     to permit continued clinical investigation.~   "
73930|NCT02089672|"~     Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter~     is introduced into the heart. These catheters can then cauterize abnormally functioning~     portions of the heart muscle with the hope of returning the heart to a more effective~     rhythm. In the process of performing such a procedure, called a catheter ablation, an~     operator must be able to accurately sense electrical activity displayed on computer screens~     in different parts of the heart, provide sufficient localized energy to the abnormally~     behaving tissue (ideally without damaging uninvolved heart structures), and accurately~     reassess the electrical activity of the heart to ensure the spot in the heart has been~     cauterized.~      When sensing electrical activity of the heart, specialized catheters produce recordings on a~     computer screen known as electrograms (EGM). To produce this recording conventional~     catheters commonly use a positive and negative electrode, from which the difference between~     the two provides the EGM. The distance between the two electrodes varies from device to~     device. The greater the distance between them, the less accurate the measurement of local~     electrical activity becomes. This may result in poorly localized or excessive use of energy~     that could be damaging to normal heart structures or put the patient at risk for the return~     or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed~     with a specialized sensing tip that uses microelectrodes that are relatively close in~     proximity (<1 mm apart) with the hope of improving the sensing capability of the device.~      This study will analyze the signals obtained from this FDA-approved catheter in people~     undergoing a catheter ablation procedure. The study will examine signals after the procedure~     is finished and will not prolong or differ the process from a standard ablation procedure.~     The goal of this study is to determine the ability of the microelectrodes to distinguish~     ablated, or cauterized versus non-cauterized tissue.~   "
73931|NCT02089659|"~     This study will investigate the influence of hepatic insufficiency on the pharmacokinetics~     (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate~     hepatic insufficiency will be compared with that of healthy control subjects matched with~     regard to mean age and weight. If a clinically meaningful increase in doravirine exposure is~     observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 will~     evaluate PK of doravirine in participants with mild hepatic insufficiency.~   "
73932|NCT02089633|"~     The propose of the study is to evaluate the maximum tolerated dose (MTD) of Oxaliplatin in~     combination with pegylated recombinant human arginase 1 (PEG-BCT-100) and Capecitabine and~     efficacy of this combination regimen (PACOX)in patients with advanced liver cancer.~   "
73933|NCT02089620|"~     Premenstrual syndrome represents a group of problems affecting most of women in reproductive~     age. These problems include emotional and physical symptoms. In this study the efficacy of~     oral contraceptive pills and calcium supplements in relieving these symptoms will be~     assessed .~   "
73934|NCT02089607|"~     Subjects for this study will have been diagnosed with a bulge or aneurysm in their abdominal~     aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the~     lower body including major organs and the legs.~      The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and~     customized physician-specified stent-graft with a combination of fenestrations and/or~     branches to repair the aneurysm.~      The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a~     tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft~     open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of~     blood with a high risk of death and other serious complications. To avoid this risk the~     aneurysm will be repaired by putting a graft in place of the aneurysm. The graft will be~     inserted through arteries in the leg (called endovascular repair). This procedure uses~     catheters that go inside the blood vessel to place a stent graft above and below the~     aneurysm.~      The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side~     branches) that allow the graft to be located above the renal arteries without blocking blood~     flow to them. These small holes or branches are the investigational part of this research~     study. This is needed when there is not enough healthy aorta below the renal arteries. At~     least one artery may also be treated with an alignment stent (small tubular stainless steel~     structures) to help keep the arteries open and aligned with the fenestrations or branches.~     The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will~     be referred to as the Zenith Fenestrated-Branched System.~   "
73935|NCT02089594|"~     Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen~     Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects~     with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).~   "
73936|NCT02089581|"~     To determine whether two new oral formulations of a strong pain killer release the drug into~     the body in a similar pattern as the already marketed reference capsule formulation with or~     without food.~   "
73937|NCT02089568|"~     The aim of this study is to see whether antibiotics given at the start of laparoscopic~     kidney donation surgery prevent infection.~   "
73938|NCT02089555|"~     African Americans are twice as likely to develop Alzheimer's disease as white Americans, but~     few African Americans are enrolled in large Alzheimer's biomarker studies. The current~     proposal aims to determine the influence of Alzheimer's disease and vascular disease on~     memory and aging in African Americans through modern biomarkers (spinal fluid, MRI, and~     amyloid imaging), and how these may differ between African Americans and white Americans in~     preparation for a large multi-center study of aging in African American.~   "
73939|NCT02089542|"~     Reliable identification of parathyroid glands is critical to the success of thyroid and~     parathyroid surgery. In thyroid surgery, inadvertent injury to parathyroid glands may cause~     temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment).~     In parathyroid surgery, early identification of normal and/or enlarged parathyroid glands~     helps in deciding on the extent of surgery and increases the chances of postoperative normal~     calcium levels.~      Methylene Blue (Methylthioninium chloride, MB) is a dye that when given intravenously in~     high doses, is taken up differently by thyroid and parathyroid tissue. It is currently used~     during parathyroid surgery by some surgeons to help identify enlarged parathyroid glands by~     visual examination alone. Such visual examination is unhelpful in the identification of~     'normal' parathyroid tissue. MB exhibits fluorescent properties in the near-infrared range~     (light just beyond the visible spectrum). This can be picked up by an appropriate imaging~     system. This has potential to identify and differentiate between 'normal' parathyroid,~     'abnormal' parathyroid and thyroid tissue during surgery.~      The investigators have established the feasibility of the intra-operative use of a near~     infra-red fluorescent imaging device called Fluobeam® and demonstrated the ability of this~     device to pick up near infra-red fluorescence from human tissue after administration of~     intravenous MB. Animal experiments have shown that doses as low as 0.1mg/kg of MB given~     intravenously enable fluorescent visualisation of thyroid and parathyroid glands.~      This study will aim to optimise the dose and timing of administration of MB in human thyroid~     and parathyroid surgery and to develop a protocol which would then subsequently be assessed~     for effectiveness in a multi-centred randomized controlled setting.~   "
73997|NCT02088788|"~     Radiation exposure to operator is an occupational hazard of invasive cardiologists. During~     radial access for diagnostic catheterization, a new radio-dense arm board is advertised to~     reduce operator radiation exposure. The investigators randomize patients to a new~     radio-dense armboard versus a standard radio-transparent armboard during diagnostic~     catheterization and measure radiation exposure to the operator. Both groups have a~     radio-dense pelvic shield in place. The investigators hypothesize that operator radiation~     dose will be decreased by use of the radio-dense armboard.~   "
73940|NCT02089529|"~     The following study investigates the role of information/expectancies in the response to~     Ibumetin and placebo.~      The study is a double-blind randomized controlled trial with crossover, within subjects~     repeated measurements. The symptoms are measured by questionnaires. 40 patients will be~     included in the study. The administrated drug is Ibumetin 400 mg.~      The study does not require patients to meet in the clinic. Patients will be instructed in~     how to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim,~     Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and~     thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the~     patients will receive a sms where they are instructed to immediately rate their pain and~     stress level and report back.~   "
73941|NCT02089516|"~     The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod~     in measuring movement / physical activity in frail elderly.~   "
73942|NCT02089503|"~     Main Objective: The main objective of this retrospective observational study was to describe~     the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy~     Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated~     with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected~     Visual Acuity (BCVA), measured at 24 months (± 4 weeks).~   "
73943|NCT02089490|"~     The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL~     protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case~     of reconstructive plastic surgery.~      The matric implantation will be followed by autologous skin grafting when the neodermis~     formation will be observed.~   "
73944|NCT02089477|"~     Low physical fitness may cause several life style related diseases e.g. cardiovascular~     disease, cancer and type 2 diabetes. It is important to develop reliable methods for~     measurement which can be used to follow the development of the physical shape both on an~     individual level and on at population level.~      Associated with the development of new training method known as Interval Walking we~     developed an application for smartphones. The use of the application InterWalk was meant to~     increase physical activity in patients with type 2 diabetes. The application should both be~     able to, 1) be a personal trainer when doing interval walking, and 2) measure the individual~     physical fitness performed as a walking test. The latter function was developed to make the~     training more personal and individal adapted, so that the training was neither too hard or~     too easy.~      It is necessary to test the walking test against a golden standard for measuring physical~     fitness and that the test in the application is able to measure and register changes in~     physical fitness.~      Our hypothesis is that the individual test, in the InterWalk Application is reliable and~     able to register changes in physical fitness in patients with type 2 diabetes. The purpose~     of this project is investigate the reliability of a smartphone-based test of physical~     fitness, and to investigate whether the test is able to register changes in physical fitness~     during the project time (3 month). A secondary aim is to investigate whether individual~     support during the training period, affect the individual effort and time of interval~     walking per week.~   "
73945|NCT02089464|"~     A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining~     active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with~     standardized task oriented rehabilitation will be conducted in patients with post-stroke~     motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6~     months later.~   "
73946|NCT02089451|"~     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic~     properties (the exposure of the trial drug in the body) of faster-acting insulin aspart~     (FIAsp) after different injection regions and routes of administration in healthy subjects.~   "
73947|NCT02089438|"~     Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and~     islet hormones. The study examines this in relation to breakfast, lunch and dinner over an~     entire 24h study period by the use of three different DPP-4 inhibitors and placebo.~   "
73948|NCT02089425|"~     This is a randomized, double blind, placebo controlled, parallel group study to assess the~     efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to~     moderate acute pain associated with ankle strain or sprain.~   "
73949|NCT02089412|"~     This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet~     doses administered either after an overnight fast or in combination with a standard high-fat~     meal in healthy subjects.~   "
73950|NCT02089399|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.~   "
73951|NCT02089386|"~     Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured~     by changes in Barrett's esophagus appearance by endoscopy and histology as well as changes~     in SOX2 and CDX2.~   "
73952|NCT02089373|"~     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure~     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for~     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or~     less. Recently, confocal laser endomicroscopy has been introduced for real-time~     histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy~     using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells~     in biopsy samples.~   "
73953|NCT02089360|"~     Blood sample is prospectively taken from consecutive patients underwent coronary angiogram~     in our center, after getting informed consent from the patients. Serum level of advanced~     glycation end products (AGEs) was measured and the clinical features of patients (including~     angiographic results) were entered into our database. Clinical follow-up was performed for~     all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further~     intervention will be adjusted according to the results,including clinical and basic research~     in lab.~   "
73998|NCT02088775|"~     This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in~     determining the radiation dose delivered with radioactive spheres to patients with liver~     metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures~     dose before and after delivery of radioactive spheres to the liver may help determine~     radioembolization dose and plan the best treatment for liver metastasis or primary liver or~     biliary cancer.~   "
73954|NCT02089347|"~     The aim of the study is to generate additional safety and immunogenicity data to support the~     registration of the product in Japan.~      Primary objectives:~        -  To demonstrate the non-inferiority of SP306 versus DT (DT BIK® 0.1mL) vaccine in terms~          of diphtheria and tetanus booster response rate (proportion of subjects with booster~          responses) and seroprotection rate (percentage of subjects with antitoxin~          concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in~          Japanese adolescents 11-12 years of age.~        -  To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in~          terms of booster response rate (proportion of subjects with booster responses) at 28~          days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of~          age.~      Secondary objectives:~        -  To further evaluate the immune response of the study vaccines against diphtheria,~          tetanus and pertussis antigens.~        -  To assess the safety of the study vaccines after one injection in Japanese adolescents~          11-12 years of age.~   "
73955|NCT02089334|"~     The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a~     target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to~     assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal~     cell cancer (Stage 2).~   "
73956|NCT02089321|"~     The purpose of this study was to investigate whether combined assessment of lumbopelvic~     control during sagittal and frontal plane motion (using two common clinical observational~     assessments) discriminates between people with and without LBP than single plane assessment~     alone. It was hypothesized that the two tests used in combination (multiplanar) would~     perform better than each test used independently (single planar) in accurately~     discriminating patient cases from healthy controls.~   "
73957|NCT02089308|"~     The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine~     patch to that of a reference formulation following repeated applications~   "
73958|NCT02089295|"~     To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation~     under fed conditions in healthy volunteers.~   "
73959|NCT02089282|"~     In an attempt to answer if clavicular length changes after a fracture e.g. that any~     shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using~     a novel ultrasound method.~   "
73960|NCT02089269|"~     The registry aims to collect and analyse information on the antineoplastic treatment of~     metastatic or locally advanced pancreatic cancer in daily routine practice in Germany. The~     registry will follow up patients for two years. It will identify common sequences of~     treatments used as well as changes in the treatment of the disease. Health-related quality~     of life will be analysed during the course of the treatment (PanLife). Based on the~     available data a prognostic score will be developed.~   "
73961|NCT02089256|"~     The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide,~     on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may~     change after repeated administration. The effect of liraglutide on insulin release will be~     tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be~     performed without medication and repeated 12 hours after first dose of liraglutide and after~     3 weeks of treatment with liraglutide.~   "
73962|NCT02089243|"~     Background: There are a variety of treatment options for medically refractory medial~     temporal lobe epilepsy. Evidence from randomized trials indicates vagus nerve stimulation~     therapy can be used as a proven therapy for medically refractory medial temporal lobe~     epilepsy. Resective surgery is one of the most commonly used methods to treat medically~     refractory medial temporal lobe epilepsy. The aim of this study is to compare the effects of~     vagus nerve stimulation therapy and resective surgery in the treatment of the medically~     refractory medial temporal lobe epilepsy.~      Methods/Design: In this article, we report the design and protocol of a randomized~     controlled trial to treat medically refractory medial temporal lobe epilepsy with vagus~     nerve stimulation therapy or resective surgery. In total, 40 patients aged 12 to 60 years~     with medically refractory medial temporal lobe epilepsy will be assessed. There are two~     treatment groups. These patients are randomly assigned to be in one of the following two~     treatment groups, i.e. 1) undergo temporal lobe resection group, 2) receive vagus nerve~     stimulation therapy group. The primary outcome is to assess whether vagus nerve stimulation~     produces a reduction in mean monthly seizure frequency that is comparable to resection at 3~     months, 6 months, 9 months and 12 months of follow-up. The secondary outcomes include the~     neuropsychological, seizure severity, seizure type, quality of life, mood assessment,~     operative and postoperative complications and long-term side effects, compared to resection.~      Discussion: The result of this trial will assess the efficacy of using vagus nerve~     stimulation therapy or resective surgery to treat medically refractory medial temporal lobe~     epilepsy, and to determine a better therapy for treating medically refractory medial~     temporal lobe epilepsy.~   "
73963|NCT02089230|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     MEK162 that can be given to patients with advanced leukemia.~      The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to~     control AML in older patients with advanced leukemia. The safety of this drug will also be~     studied.~   "
73964|NCT02089217|"~     Carotid revascularization for primary prevention of stroke (CREST-2) is two independent~     multicenter, randomized controlled trials of carotid revascularization and intensive medical~     management versus medical management alone in patients with asymptomatic high-grade carotid~     stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no~     endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with~     embolic protection versus no stenting. Medical management will be uniform for all randomized~     treatment groups and will be centrally directed.~   "
74010|NCT02088619|"~     The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and~     acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy)~     modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2)~     obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes~     in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion,~     mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT~     will promote improvements in autonomic function, reduced arrhythmia frequency, and improved~     psychological well-being.~   "
73965|NCT02089204|"~     Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies in terms of its~     epidemiology, pathology, and treatment outcome . It is endemic in China and is one of the~     major public health problems. Concurrent radiotherapy and chemotherapy is the primary~     treatment for patients with NPC. Despite such aggressive treatment, many patients with~     locally advanced NPC still develop locally recurrent disease. Since local control is~     directly related to patient morbidity and mortality in NPC, there is a strong need to~     identify methods to further improve treatment outcome for NPC.~      One strategy to improve local control is to escalate the dose of radiotherapy. This is~     because local control has been shown to be directly related to the radiotherapy dose.~     Several different techniques, including brachytherapy, stereotactic radiosurgery, and~     dose-painting intensity modulated radiotherapy (IMRT), have been used to increase~     radiotherapy dose. However, due to the large number of critical anatomic structures near the~     nasopharynx, dose-escalation in NPC can also lead to increased toxicities. One technique~     that has achieved dose-escalation with minimal increase in toxicity is simultaneous~     modulated accelerated radiation therapy (SMART). The main challenge for such treatment is to~     identify the appropriate tumor volume to receive the high-dose radiotherapy. Conventional~     dose-escalation is conducted using computed tomography (CT) to identify the gross tumor~     volume (GTV). However, recent progress with F-18 fluorodeoxyglucose positron emission~     tomography/computed tomography (18F-FDG-PET/CT) in treatment planning allows more accurate~     tumor volume delineation. We hypothesize that the use of PET/CT in treatment planning can~     improve dose-escalation radiotherapy for NPC which in turn can improve therapeutic efficacy~     while reducing toxicity. PET/CT imaging of tissue hypoxia using [F-18]fluoromisonidazole~     (FMISO), the most widely used nitroimidazole imaging agent.Given that there has been no~     clinical trials directly comparing conventional chemoradiotherapy to CT-guided~     dose-escalation chemoradiotherapy or PET/CT guided dose-escalation chemoradiotherapy in~     locally advanced NPC.This was a study to evaluate the role of FMISO-PET hypoxia imaging for~     predicting survival in NPC,our study aims to compare the local control, overall survival and~     toxicities of the three treatment regimens..~   "
73966|NCT02089191|"~     The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus®~     (DACP) compared to MyDay® after 12 hours of lens wear.~   "
73967|NCT02089178|"~     The purpose of this study is to compare the effect of total intravenous anesthesia and~     inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor~     in patients undergoing breast tumor resection. Using propofol-remifentanil in total~     intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.~   "
73968|NCT02089165|"~     The purpose of the study is to compare the acute bioavailability of two different krill oil~     products called krill oil and krill meal in comparison to fish oil product.~   "
73969|NCT02089152|"~     Study hypothesis:~      Prevention programme for melioidosis can reduce incidences of overall hospitalization due to~     infectious diseases and due to culture-confirmed melioidosis in diabetic population in~     northeast Thailand~      This study is a prospective single-blind multicentre stepped wedge cluster randomized~     controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast~     Thailand.~   "
73970|NCT02089139|"~     Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is~     mainly based on MR imaging, showing MODIC I or II changes in patients with concordant~     symptomatology. The treatment of discogenic low back pain is nevertheless difficult:~     intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited~     efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse~     with notable risk of side-effects.~      In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in~     patients with disabling discogenic pain is assessed.~   "
73971|NCT02089126|"~     The study objective is to demonstrate the superiority and safety of the combination therapy~     (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride~     monotherapy in patients with type 2 diabetes.~   "
73972|NCT02089113|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical~     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular~     lens implantation.~   "
73973|NCT02089100|"~     The previous reported phase I study allows us to prospectively define the optimal total dose~     in different metastatic locations (88). However, several questions are still unanswered such~     as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic~     disease. Indeed, there are two different oligometastatic states: de novo, i.e. occurring~     at first metastatic presentation without any previous systemic therapy; and secondary,~     defined as residual disease after systemic treatment.~      The investigators wish to prospectively study the role of metastases SBRT with curative~     intent in de novo oligometastatic disease.~      This clinical trial would be the first randomized study studying SBRT at onset of the~     metastatic disease. If this trial shows a PFS improvement, it will definitively change the~     standard of treatment and it will highlight SBRT as a key treatment of metastatic disease.~     It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).~   "
73974|NCT02089087|"~     This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics,~     and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy~     subjects and intravenous doses in rheumatoid arthritis patients.~   "
73975|NCT02089074|"~     Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack~     (TIA), but studies show that adherence to the prescribed drugs is often poor. This~     randomised controlled trial aims to investigate whether a systematic follow up of drug~     treatment using medication reconciliation, medication reviews and patient counselling by~     clinical pharmacists, improves adherence and/or decreases cardiovascular events the first~     three months and the first year after TIA. Patient satisfaction will also be compared~     between the two groups.~   "
73976|NCT02089061|"~     This purpose of this study is to assess the effects of BMS-919373 on the single dose~     Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.~   "
73977|NCT02089048|"~     Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once~     every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose~     of auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples~     will also be obtained for the measurement of gold.~   "
74011|NCT02088606|"~     A prospective, multicenter, interventional study to collect confirmatory evidence on the~     safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment~     of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated~     radiofrequency ablation.~   "
74017|NCT02088528|"~     Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of~     medications, disease severity and poor compliance. Surgical treatment is likely to be a more~     practical solution.~      The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma~     drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical~     study.~   "
73978|NCT02089035|"~     The consumption of milk and dairy products is recognised as an essential part of a healthy~     diet as it represents an important source of key micro- and macronutrients. Nevertheless,~     there is still a widespread conviction that the overall high energy density and~     concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental~     health effects, contributing to the progression of cardiovascular disease, obesity and~     diabetes.~      Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an~     achievable strategy in order to reduce the amount of SFA present in dairy products.~      The aim of this project is to observe the effects of three types of dairy products (UHT~     milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower~     oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased~     risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy~     products will affect vascular function and CVD biomarkers.~   "
73979|NCT02089022|"~     The aim of this study was to evaluate the effect of ice and shortwave diathermy in different~     regions of lower limb neuromuscular response and balance.~   "
73980|NCT02089009|"~     1. To compare quality and usability of images taken by two different camera-systems~          without dilating the pupil.~        2. To compare the retinal vessel diameters based on the images of to different~          camera-systems.~        3. To detect changes in retinal vessel diameters while pregnancy and after delivery.~   "
73981|NCT02088996|"~     Chemotherapy-induced peripheral neuropathy (CIPN) implies sensory or deficits pain, loss of~     motor functions and impaired proprioception which in turn may affect balance and fine motor~     skills. It is mainly subjected to the peripheral parts of the extremities, may be transient~     or permanent.CIPN is a common, potentially severe and often dose-limiting side effect after~     patient exposure of numerous classes of antineoplastic agents including platins, taxanes,~     vinca alkaloids, bortezomib and thalidomide. At present, no evidence based treatment of CIPN~     is available. A variety of different drugs or drug combinations have been clinically tested~     but the value of these treatments is uncertain. Many patients with CIPN are referred to~     physiotherapy but still this treatment is more based on clinical experience and tradition~     than scientific evidence. In a nonrandomized study, sensory electrical stimulation(MC5-A~     Calmare ®) was tested on 16 persons.The electrodes were placed on the hand and foot and~     intensity was gradually increased and given daily for 10 days. Pain was reduced 20% in~     numeric pain score for 15 of the 16 participating patients.~      Our clinical experience indicates that treatment with long wave diathermy (LWD) may decrease~     CIPN symptoms. This treatment produces electromagnetic radiation according the capacitor~     method with heightened circulation and heat which is assumed to reduce pain. Interferential~     Therapy (IT) is an electro-physical method which is based on an electric field in the~     painful area through four electrodes or vacuum cups placed on the skin. Increased blood~     circulation and pain relief is supposed to be achieved. IT use two different intermediate~     frequencies (1001-10000 Hz) alternating currents in the painful area. The treatment effect~     correspond to the gate control-theory; inhibition of pain signals in small diameter fibers~     by activity in large-diameter Aβ-fibers by spinal neurons. Some studies have shown effect in~     treating pain with interferential currents when pain is experimentally induced or induced by~     cold in otherwise pain-free volunteers, when compared to a control or placebo.~      The hypothesis of this study is that the combination therapy longwave diathermy on high~     power and interferential currents gives better results than longwave diathermy on low power.~   "
73982|NCT02088983|"~     People with schizophrenia tend to have problems with attention and concentration. Studies~     found that these patients are unable to block or gate out non-relevant and distracting~     information (e.g., noises). This may lead to brain overload. Cognitive abilities like~     concentration, memory, and learning may worsen. This ability to filter sensory information~     has been linked to a gene that affects the way nicotine acts in the brain. Patients with~     schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of~     the general population. It has been suggested that these patients may use nicotine to~     improve their ability to block out distracting information. Brain wave activity (EEG) in~     response to sounds has been proved useful in understanding this gating problem. The present~     study uses EEG measures and performance tasks to find out what a new nicotine-like~     treatment, which will be added to ongoing treatment medications, does to gating and~     cognition. It is hoped that this new treatment will improve the way in which patients~     process information, as this may help them in day-to-day activities.~   "
73983|NCT02088970|"~     The corneal collagen cross linking is currently used in the treatment of keratoconus but~     this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the~     corneal cross linking in association with the antibiotic treatment could result in a~     reduction of the duration of epithelial complete healing of the cornea.~   "
73984|NCT02088957|"~     The primary objective of this study is to compare the efficacy of Brivaracetam and~     Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive~     electrographic seizures.~   "
73985|NCT02088944|"~     Many studies reveal that infliximab (IFX, an immunoglobulin gamma-1 antibody)can response~     well to Crohn's Disease(CD) patients who are intolerant of corticosteroids and~     immunosuppressant,or steroids-dependent .More over,A complex fistula in CD is an indication~     for early IFX therapy in conjunction with surgical drainage.Some papers claim that IFX may~     prevent enterectomy CD patients from relapsing. Those with risk factors which at diagnosis~     associated with  disabling disease include age < 40 years, initial need for steroid~     therapy, and the presence of perianal disease are recommended to use IFX early.~      IFX is approved by State Food And Drug Administration(SFDA) in 2007 ,but the safety is still~     controversial by then.Some studies proclaim that the side effect may be infections,acute~     infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart~     failure,abortion and demyelination,etc.~      So some problems still need to be settled as follows:1)all the the infliximab dates are from~     other countries,there is rare date from the Chinese,especially the large quantity of random~     controlled studies and the CD patients with enterectomy.2)despite of the large number of~     databases from the international ,when to stop and the predictor of the response is still~     obscure.3)The high cost of IFX may hinder its applications,especially for the moderate to~     severe active CD patients who take mesalazine and/or immunosuppressant to maintain~     remission.In addition,the pathogenic age segments in the occurence of CD: from 15~ 50 years~     old ,so they suffer from the disability of self-improvements.~      The main object of the clinical trial is to complete the database of Chinese CD patients~     ,especially the safety and efficacy of IFX and those with enterectomy.Then we can record the~     clinical manifestations of the moderate to severe CD patients with the use of IFX or~     conventional drugs,including the dose,course and Concomitant treatment.We can also study the~     predictor and the appropriate time to stop using IFX .We can make the mode of cost-benefit~     help the patients choose the best project.~   "
74012|NCT02088593|"~     Medical students score higher than the general population on measures of depression,~     anxiety, fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase~     might contribute to these problems. From an internal validity standpoint, first year medical~     students are an ideal group to study. The majority of the students will be matched on~     variables such as education, age, and intelligence. However, more importantly, they have a~     nearly identical life style when it comes to factors such as schedule, living conditions,~     level of stress, and timing of stressors. The specific aim and hypothesis is:Medical~     students randomized to sleep hygiene counseling plus simulated dawn will report less~     depression, anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized~     questionnaires) than students randomized to just sleep hygiene counseling.~   "
73986|NCT02088931|"~     The purpose of this study is to test the safety of the experimental therapy of a single~     infusion of Regulatory T cells (Tregs). The investigators want to find out what effects,~     good or bad, Tregs will have on the kidney transplant patients.~      There are different types of T cells. This study uses Regulatory T cells (Tregs), which are~     found in the blood and are part of the immune system that stops other immune cells from~     working. Tregs help to turn off the immune system after other immune cells have finished~     tackling outside infections, and Tregs keep the immune system in check so that the body does~     not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the~     attack on the kidney can be stopped and kidney function will be stabilized. It is not known~     if the Treg experimental therapy can stop the inflammation in the kidney.~      In this study, the researchers will take some of Tregs from the patient, multiply them in~     the laboratory, and then infuse them back into the patient. The procedure used to multiply~     Tregs is an experimental process performed in the laboratory. Similar procedures done with~     mice have been shown to reverse inflammation but it is not known whether the results will be~     the same in humans. This therapy has not yet been done in humans outside of a research~     study.~   "
73987|NCT02088918|"~     A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess~     Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a~     Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in~     Healthy Male Subjects~   "
73988|NCT02088905|"~     The aim of the current proposal is to determine if the PCIT treatment manual can be~     successfully utilized for preschoolers with ASD and disruptive behavior (across a range of~     intellectual functioning levels) and to evaluate its ability to significantly decrease~     measures of problem behavior. It is hypothesized that the current manual will require few~     modifications for use with ASD and that, in comparison to a wait-list control group,~     families who undergo PCIT training will evidence significant gains on measures of parenting~     stress, child externalizing behaviors and compliance to parental requests. To address the~     pilot study aims, we will recruit a total of 20 families of children with ASD (ages 2.6-6.11~     years) whose children are already receiving intensive, one-on-one behavioral treatment~     services (15-30 hours per week) but no structured parent training. Families will be~     randomized to either intensive services + PCIT or intensive services alone (wait list~     control). Assessments will be completed at baseline, mid-treatment (10 weeks post baseline),~     post-treatment (20 weeks after the baseline assessment) and long-term follow-up (12 weeks~     post-treatment). PCIT families will attend 20 weekly, one-hour coaching sessions. Both~     active treatment and wait-list control families will continue to receive intensive ABA~     services in the home or community. Control families will receive PCIT training after 16~     weeks on the wait-list. The aims of the pilot study are:~        1. To assess the utility of the current PCIT treatment manual with preschoolers with ASD~          and disruptive behavior and their parents;~           Hypothesis 1: The current PCIT treatment manual will be able to be utilized with~          families of children with ASD with only minimal modifications.~           Hypothesis 2: Families of children with ASD will consistently attend PCIT sessions.~        2. To determine if PCIT with this population will result in an increase in appropriate~          parent behaviors and a subsequent decrease in targeted child behaviors (e.g., direct~          assessment of noncompliance, behavior rating scales).~      Hypothesis 3: Families receiving PCIT training will evidence statistically greater decreases~     on measures of disruptive behavior, quality of parent-child interactions and parental stress~     than families on the wait-list control group.~      Hypothesis 4: Gains attained at 20 weeks will be maintained at a 12-week post-treatment~     follow-up.~   "
73989|NCT02088892|"~     TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin~     (BCG) vaccine at standard and high dose.~   "
73990|NCT02088879|"~     The chest compression depth decreases over time after starting continuous chest compression~     due to the rescuers' fatigue.~      The investigators hypothesized that the frequency parameters from surface electromyogram~     from each muscle during chest compression may reflect the muscle fatigue of the rescuers.~      Then investigators can identify which of the body are mainly used and get tired by~     continuous chest compression using surface electromyogram.~   "
73991|NCT02088866|"~     The purpose of this investigation is to evaluate if topically applied lidocaine, in the form~     of lidocaine patches, reduces the burden of chronic subjective tinnitus in a consistent and~     measurable way.~   "
73992|NCT02088853|"~     Human beings are 'omnivores' meaning that all principal components of food (i.e. the~     macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal~     tract. When the gut mucosa is exposed to dietary changes it adjusts its functional~     behaviour. For example, a fatty diet demands certain digestive mechanisms, whereas others~     are needed to take care of a carbohydrate rich diet. Such dietary induced changes in~     appearance and functionality of the small intestinal mucosa have been described in animals~     but only little is known about it in man. The present project aims at elucidating in man if~     a 2 weeks diet dominated by either fat or carbohydrates, but with similar energy content, is~     associated with changes in the small intestinal mucosal appearance and metabolic signalling~     capacity.~   "
73993|NCT02088840|"~     All patients undergoing autologous or allogeneic stem cell transplant (SCT) for any~     underlying disease will be monitored for severe infections by gram negative bacteria (SIGNB)~     during the engraftment period. The follow up will be stopped at 4 months from the day of~     transplant. About 50 transplant centers will be involved in the study.~   "
73994|NCT02088827|"~     The rates of sedentary activity are increasing. Studies have shown that time spent on doing~     sedentary activities is an independent risk factor for cardiovascular disease. Prior studies~     have shown that interrupting inactivity improved the body's handling of blood glucose and~     gene expression. The investigators plan to explore this further by examining the effects of~     interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20~     minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein,~     glucose and insulin levels.~   "
73995|NCT02088814|"~     Background: Previous studies have found considerable rates of posttraumatic stress disorder~     (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with~     injuries following accidental trauma. In consequence, secondary preventive efforts (early~     interventions) should be undertaken to minimize such long-term deleterious consequences in~     children.~      Aims: The proposed study aims at examining the effect of a newly developed, standardized~     early psychological intervention in reducing posttraumatic maladjustment and in enhancing~     health-related quality of life in children ages 1 to 4 years with acute burn injuries.~      Method: The study is designed as a randomized controlled trial within a stepped procedure.~     First, eligible children will be screened 5 to 7 days post injury by means of a standardized~     measure for their risk of developing PTSS. After a baseline assessment, children at risk~     will then be randomly allocated to either a control group (standard medical care) or an~     intervention group. Participants of the intervention group will be provided with the~     standardized EPICAP 1-4 intervention which uses established cognitive-behavioral~     techniques and is directed to the parents. The intervention consists of two face-to-face~     sessions (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face~     meeting (6 weeks after the first session). Blinded follow- up assessments with standardized~     parent report measures will be conducted at 3 and 6 months post injury. The primary outcome~     measures are child PTSD and PTSS, secondary outcome measures include child behavior and~     health-related quality of life. In addition, a variety of socio-demographic, medical and~     parental variables will be assessed as co-variates. Children screened as low-risk will be~     reassessed only at 6 months to make sure that the screening procedure is valid.~   "
74018|NCT02088515|"~     The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin~     is a second-generation platinum compound that is more active against squamous cell carcinoma~     of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.~   "
73999|NCT02088762|"~     Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm~     surgical margins on survival of the patients compared with 2 cm surgical margins.~      Background: Early recognition and appropriate excision play a crucial role in management of~     malignant melanoma, while the size of surrounding normal skin that should be excised is area~     of controversies.~      Methods: The investigators will conduct a retrospective population-based survey in patients~     with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm~     margins in the investigators center. For both groups, the patients' charts reviewed for data~     including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness,~     tumor type, presence of ulceration, findings of sentinel nodes, local recurrences,~     locoregional metastases, disease free survival and overall survival were calculated for both~     groups.~   "
74000|NCT02088749|"~     The purpose of this study is to compare the 6- and 12-month weight changes associated with~     lifestyle interventions delivered in a large group or small groups of participants. It is~     hypothesized that participants receiving treatment in a small group will have greater weight~     loss than those assigned to a larger group.~   "
74001|NCT02088736|"~     In patients with out-of-hospital cardiac arrest in Singapore, investigators aim to assess~     the benefit of introducing a resuscitation protocol including the use of intravenous (IV)~     access and/or intraosseous (IO) vascular access in the pre-hospital setting.~      The assumption is that low vascular access rates could be due to difficulty of setting IV~     cannulas in the field due to certain factors like poor lighting or space constraints. Thus,~     by introducing a protocol including IO access for difficult IV cases, success rates for~     vascular access will be higher and this might lead to higher survival rates.~      This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac~     arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The~     trial will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide~     both 'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow~     for all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the~     accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.~   "
74002|NCT02088723|"~     The purpose of this study is to determine if the elevation of the head of the bed in~     patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the~     investigators will do a standard polysomnography and see if the patients are included~     analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the~     patient will do the second polysomnography but this will be with a elevation of the head of~     the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will~     compare the data of apnea-hypopnea index in the standard polysomnography versus the index~     with the elevation of the head of the bed.~   "
74003|NCT02088710|"~     The purpose of this study is to evaluate the role of patients' response expectations for~     nocebo side effects, quality of life and adherence during adjuvant endocrine treatment~     (AET). Furthermore, this study analyses the effects of a structured treatment information on~     patients' satisfaction with information, response expectations, knowledge and adherence.~   "
74004|NCT02088697|"~     The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and~     sertraline Tablet in Japanese healthy male subjects.~   "
74005|NCT02088684|"~     The purpose of this trial is to explore the clinical utility of the three investigational~     agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class~     I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with~     fulvestrant.~      This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a~     dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant;~     LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.~      The Phase II portion of the study will be a randomized study to assess the anti-tumor~     activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120~     with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally~     advanced or metastatic breast cancer.~      Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer~     will be enrolled.~   "
74006|NCT02088671|"~     The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate~     monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate~     whether the information provided by the NeuroSENSE Monitor can help in assessing the~     hypnotic effect of anesthetics in adult patients undergoing general anesthesia.~   "
74007|NCT02088658|"~     The purpose of this study is to test the usefulness of an intervention that combines~     technology with diabetes education and skills training. This study has been designed~     specifically for African Americans with poorly controlled type 2 diabetes.~   "
74008|NCT02088645|"~     The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy~     of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin~     analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on~     more than 90 % of medullary thyroid carcinomas.~      In the pilot (phase 0) study we will correlate the tumour detection rate with the surgery~     and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies~     will be performed in order to determine the kidney protection protocol and starting activity~     for the dose escalation study in the following, dose escalation (phase I) study. In the~     phase I study we will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients~     with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well~     as organ radiation doses and maximal tolerated dose will be performed in order to allow~     prospective individual patient tailored therapy planning.~   "
74009|NCT02088632|"~     IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain~     chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular~     junction by inhibiting the release of acetylcholine from motor neurons. In addition it~     blocks the release of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C~     fibers involved in pain perception. This study is designed to see if Xeomin® is superior to~     placebo in the treatment of medically refractory trigeminal neuralgia (TN). Subjects will be~     asked to maintain an attack diary throughout the study. They will also be asked to attend 4~     office visits; Visit 1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit~     and Visit 4- Final Visit. At the end of the study the active (Xeomin®) and placebo groups~     will be compared to see if one group had better relief than the other.~   "
74019|NCT02088502|"~     The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and,~     and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy.~     Investigators assume that Theophylline plus N-acetylcysteine is more effective than~     Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for~     elective coronary angiography or angioplasty and allocate them to each of the mentioned~     treatments from 24 hours before to 48 hours after administration of contrast material.~     Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25%~     of the baseline value.~   "
74020|NCT02088489|"~     Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with~     the same safety.~   "
74021|NCT02088476|"~     Candidemia has emerged as an important cause of hospital-associated blood-stream infection~     in children. The purpose of this study was to identify differences in distribution of~     candida species, risk factors, treatment, and clinical outcome of candidemia in children.~     This study in children ≤18 years with blood culture proven candidemia identified between~     2004 and 2012. Analyses included the determination of causative candida species, resistance~     to antifungals and clinical outcome, as well as the identification of potential risk factors~     associated with candidemia.~   "
74022|NCT02088463|"~     The study was conducted to the following purposes~        1. To investigate the effect of lumbar mobilization on muscle activity in postpartum~          mechanical low back pain.~        2. To investigate the effect of lumbar mobilization on pain intensity in postpartum~          mechanical low back pain patients.~        3. To investigate the effect lumbar mobilization on functional disability in postpartum~          mechanical low back pain patients.~        4. To compare between the effects of lumbar mobilization, tactile stimulation (placebo~          treatment) and traditional treatment in postpartum mechanical low back pain patients.~   "
74023|NCT02088450|"~     The Syst-Eur Trial is a concerted action of the European Community's Medical and Health~     Research Programme. The trial is carried out in consultation with the World Health~     Organization, the International Society of Hypertension, the European Society of~     Hypertension and the World Hypertension League. Syst-Eur is a multicentre trial designed by~     the European Working Party on High Blood Pressure in the Elderly (EWPHE), to test the~     hypothesis that antihypertensive treatment of elderly patients with isolated systolic~     hypertension results in a significant change in stroke morbidity and mortality. Secondary~     endpoints include cardiovascular events, such as myocardial infarction and congestive heart~     failure. To be eligible patients must be at least 60 years old and have a systolic blood~     pressure averaging 160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must~     give their informed consent and be free of major cardiovascular and non-cardiovascular~     diseases at entry. The patients are randomized to active treatment or placebo. Active~     treatment consists of nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and~     hydrochlorothiazide (12.5-25 mg/day), as necessary. The patients of the control group~     receive matching placebos. The drugs (or matching placebos) are stepwise titrated and~     combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150~     mmHg. Morbidity and mortality are monitored to enable an intention-to-treat and per-protocol~     comparison of the outcome in the 2 treatment groups.~   "
74024|NCT02088437|"~     Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip~     fractures are a significant problem for the older people, the hospital system and community~     as a whole because of the increasing numbers of fractures and the cost of hospitalisation~     and ongoing care. After one year, less than half of all people with a hip fracture can walk~     as well as they did before the fracture. Physiotherapy in the acute hospital setting is an~     integral part of patient care, although the intensity of physiotherapy a patient receives is~     variable and the optimal number of treatment sessions per day remains unknown. Studies in~     other patient groups have shown that increased physiotherapy can improve patient outcomes by~     increasing muscle strength and mobility. It can also reduce the negative effects of bed rest~     such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as~     pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy~     program in hip fracture patients to further understand this and the effect it has on patient~     function.~      In this research the investigators will randomly allocate patients into 2 groups; usual care~     and intensive physiotherapy. The usual care group will have physiotherapy treatment daily~     whereas the intensive physiotherapy group will have an additional daily treatment by a~     physiotherapist as well as a daily treatment by an allied health assistant. The objectives~     are to achieve better functional outcomes in the patient's hospital stay (ie improved~     mobility), reduce the time for patients to be physically ready to go home, increase the~     number of patients able to go directly home or to fast stream rehabilitation (rather than a~     slow stream option).~      If increased intensity of physiotherapy is found to improve patient's mobility outcomes,~     this research will provide the confidence to endorse a change to current clinical practice.~   "
74025|NCT02088424|"~     THE INSULIN RESISTANCE IN RECURRENT ABORTION~   "
74026|NCT02088411|"~     The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial~     was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults~     with moderate-to-severe osteoarthritis (OA) of the knee.~   "
74027|NCT02088398|"~     This study will be an open-label, randomized, single dose, 3-period crossover PK study. This~     study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1,~     subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects~     will be administered Treatment A, B, or C according to the randomization schedule.~        -  Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state~        -  Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state~        -  Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state~   "
74028|NCT02088385|"~     Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder~     hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides~     significant ease of administration compared to the combined conventional technique of~     saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray~     powder is easily applied on ulcers at difficult endoscopic positions and ulcers with~     fibrotic bases, where the combined conventional technique has limited efficacy. Building up~     on preliminary work from small single-arm studies, the investigators aim to establish the~     efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the~     combined conventional technique. The investigators propose a pilot study to establish our~     centre's feasibility of performing a prospective, randomized, parallel group trial, which~     compares the efficacy of Hemospray with the combined conventional technique, in the~     endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding~     peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate~     (defined as endoscopically verified cessation of bleeding for at least 5 minutes after~     endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period~     following the initial hemostasis) and its safety profile.~   "
74032|NCT02088333|"~     The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC)~     can increase the percentage of patients who receive colorectal cancer screening. The mCRC~     intervention will include a tablet-based patient education program, clinic protocols to~     facilitate the ordering of CRC screening tests, and electronic messaging with patients to~     promote screening. The investigators hypothesize that participants randomized to mCRC will~     be more likely to complete screening compared with those randomized to the control arm of~     the study. Additionally, the investigators hypothesize mCRC will increase several~     intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will~     predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention~     will add little to the overall cost of screening.~   "
74033|NCT02088320|"~     The focus of the present study is to further develop an echocardiographic technique to~     measure cardiopulmonary transit time (PTT) and pulmonary blood volume (PBV) using ultrasound~     contrast.~      The Specific Aims for the present study are as follows:~        1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a~          'peak-to-peak' method~        2. To further quantify the relationship between echocardiographically-derived PTT, using~          Optison, and existing echocardiographic methods used to determine ventricular function~        3. To measure the reproducibility of echocardiographically-based PTT using Optison.~   "
74034|NCT02088307|"~     Evaluation of the metabolic and physiological characteristics of patients with diagnosed~     Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.~   "
74035|NCT02088294|"~     The childhood obesity epidemic, which falls disproportionately on Latino adolescents,~     represents a major public health threat to the current generation of youth, and therefore to~     the health of the nation overall. This project directly addresses the role of psychosocial~     stress in promoting obesity and metabolic disease risk, and investigates the role of the~     mind-body CAM intervention of guided imagery in both reducing stress and promoting healthy~     lifestyle behaviors that could dramatically improve the metabolic health of today's youth.~   "
74036|NCT02088281|"~     The potential effect of indigo naturalis on the immune system is unknown. The investigators~     hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve~     inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines,~     thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.~   "
74037|NCT02088268|"~     The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer~     foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate~     the efficiency and the clinical application of PRP on serious wound healing.~   "
74038|NCT02088255|"~     The purpose of this study is evaluate the effects of walking training with partial body~     weight support on static (floor) and dynamic (treadmill) surfaces in individuals with~     hemiparesis due to stroke. For this purpose, two training protocols will be employed in~     three experimental groups: G1 will do the walking training with partial body weight support~     on static surfaces and G2 will do the walking training with partial body weight support on~     dynamic surfaces~   "
74039|NCT02088242|"~     Exposure to heat stress can compromise the physiological and cognitive function and be life~     threatening, particularly in a military setting. Various strategies of precondition to heat~     stress that have been explored in the past proved to be inapplicable. We aim to examine the~     influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a~     human model using a heat tolerance test. This will be achieved by a double-blind, placebo~     controlled supplementation trial, exposing human subjects, before and after consuming~     Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate~     exercise in a heated chamber.~   "
74040|NCT02088229|"~     This longitudinal interventional case series will utilize the patients at the University of~     Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema.~     Baseline measures will be taken which include structural assessments such as circulatory~     capacity utilizing fluorescein angiography, in addition to retinal layer integrity and~     thickness using high resolution optical coherence tomography. Also, functional assessments~     such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation,~     perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and~     compared with historical controls to ensure that currently accepted interventions are safe.~     Finally, potential confounding variables for DME including those related to the eye,~     systemic factors, and patient demographics will be recorded to assess the influence of these~     variables on treatment response.~      The primary objective is to develop hypotheses that might better explain the retinal~     structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in~     eyes receiving treatment for diabetic macular edema (DME).~   "
74041|NCT02088216|"~     Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can~     reduce the frequency of acute exacerbations of patients with non-cystic fibrosis~     bronchiectasis and improve their quality of life.~      Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the~     observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or~     the control group (participants receive oral tablet BID for 12 months). The primary endpoint~     was the frequency of acute exacerbations.~      Expected results: Compared with the control group, the frequency of acute exacerbations of~     the observer Group will decrease significantly.~      Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations~     of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.~   "
74042|NCT02088203|"~     Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.~   "
74043|NCT02088190|"~     The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell~     function, and inflammation will be greater, and the improvement in sarcopenic obesity will~     be less, in younger versus older individuals after substantial weight loss induced by sleeve~     gastrectomy bariatric surgery.~   "
74095|NCT02087514|"~     This study will determine the minimal duration of red blood cell (RBC) storage that leads to~     increases in circulating non-transferrin-bound iron in healthy human volunteers~     post-transfusion. The results from this study will help guide national guidelines for~     appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food~     and Drug Administration (FDA) criteria. The overall objective of this research is to improve~     the safety of refrigerated storage of red blood cells before transfusion.~   "
74044|NCT02088177|"~     This is an 8 week, outpatient research study testing the use of long-acting naltrexone~     (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is~     effective in treating dependence on opiates and opioids, and in treating dependence on~     alcohol. It is FDA approved for these disorders. It is a long-acting medication that~     contains enough medicine in each injection to last for one month. One way it works is by~     blocking the effects of opiates, including opiates released by the body in response to drugs~     and alcohol. In this study, we are interested in testing the effects of Vivitrol in people~     with marijuana dependence.~      Individuals participating in this study will receive two Vivitrol injections, each given~     four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock~     on one side. Participants will attend clinic visits two times a week during this 8-week~     study for medical management for drug use and for monitoring of physical and psychological~     health.~   "
74045|NCT02088164|"~     To determine the long-term survival outcome of subjects who had various PSA levels at~     screening~   "
74046|NCT02088151|"~     Laser photocoagulation of the retina targeting the outer layers is an established therapy~     for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal~     vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular~     membranes. However, collateral damage occurs and scotomas can result when using conventional~     lasers with pulse duration of 100ms and more. This is particularly relevant for laser~     treatments of the macula where the main therapeutic effect results from stimulation of the~     retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary~     side effect. Recent experimental research with new laser devices using much shorter pulse~     duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment~     epithelium selectively targeted, hence the term selective retinal pigment epithelium laser~     therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser~     photocoagulation for macular disease but minimizes local visual field defects.~      In this study, patients with central serous retinopathy, macular edema from diabetic~     microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration~     will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.~   "
74047|NCT02088138|"~     The purpose of this study was to determine the effects of Functional Electrical Stimulation~     (FES) on physical performance and quality of life of patients in cardiac rehabilitation.~   "
74048|NCT02088125|"~     The purpose of the study was to analyze the effect of IS and BS on dynamics ventilatory and~     asymmetry of the chest wall in patients after stroke .~   "
74049|NCT02088112|"~     This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with~     MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study~     consists of two phases: Escalation phase and an expansion phase to be conducted in locally~     advanced or metastatic NSCLC subjects~   "
74050|NCT02088099|"~     Mayo Clinic has been funded by the National Institute on Disability Independent Living &~     Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center~     continuously since 1998. We have successfully competed for this funding because we~     consistently produce high quality research and because we provide comprehensive team-based~     rehabilitation services to people with TBI and their families over the continuum of care~     that is associated with superior outcomes.~      Lack of access to specialized TBI care is the most common need identified by individuals~     after they are hospitalized for TBI. The upper Midwest has some of the highest populations~     of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI~     and are more likely to have limited access to rehabilitation services after acute care.~     Explosive advances in communication technology have brought tele-medicine to the forefront~     of health care. The CONNECT trial will test the effectiveness of using modern technologies -~     such as phone consultation and other telehealth communication systems - to deliver~     specialized brain rehabilitation resources remotely to patients and providers in the upper~     Midwest. The groups targeted by the CONNECT trial are:~        -  Individuals recently hospitalized with TBI;~        -  Their families;~        -  Their local health care and other providers (primary care providers, psychologists,~          therapists, social service providers, job counselors).~      The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND,~     and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD),~     and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome~     can be improved by providing care with no face-to-face contact. The trial will study whether~     outcomes over three years are different in the group receiving this remotely provided model~     of care compared to a matched group that receives usual care in their communities.~      The desired long term outcome of this study is to increase our capacity to provide care and~     to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals~     with TBI and their families.~   "
74051|NCT02088086|"~     The Fit Study is a three-year, cluster-randomized controlled trial that will evaluate the~     impact of school-based body mass index (BMI) screening and reporting on child health.~     Seventy-five California schools will be randomized to one of three groups: 1) BMI screening~     and reporting, 2) BMI screening, and 3) no BMI screening or reporting (control).~     Investigators will assess the impact of BMI reporting on students' BMI trajectories over~     three years. Investigators will also assess the impact of BMI screening on weight-based~     teasing, feelings of stigmatization, and weight-control behaviors among students.~   "
74052|NCT02088073|"~     It is hypothesized that ZS is more effective than placebo control (alternative hypothesis)~     in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum~     potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom~     normokalemia was established during the open-label acute phase versus no difference between~     each ZS dose (highest to lowest) versus placebo control (null hypothesis).~   "
74053|NCT02088060|"~     Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's~     population. Current antipsychotics are only partially effective, and their use is often~     associated with serious side effects. Cannabidiol is a natural counterpart of the~     psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no~     psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid~     signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled~     clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute~     paranoid schizophrenics the investigators showed a significant clinical improvement in all~     symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol~     displayed a significantly superior side-effect profile. This study is to evaluate the~     efficacy and safety of this novel treatment option in comparison to placebo and olanzapine,~     an established second generation antipsychotic in the treatment of acute schizophrenia and~     schizophrenia maintenance therapy, in a four-week clinical trial.~   "
74150|NCT02086773|"~     The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL,~     has a safety profile similar to that of the current standard transfusion threshold of 8~     g/dL.~   "
74054|NCT02088047|"~     This study is designed to pilot an intervention technique to reduce the self-stimulating~     behaviors seen in individuals with autism spectrum disorders using intervention with~     ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and~     rocking, can interfere with the individual's ability to interact with their peers.~     Participants will wear the pellets for four week and measures with taken again. Another~     group of participants will not get the pellets. Both groups will be tested at the beginning~     and end of the study. Any variations in self-stimulating behaviors will be documented~     through parent report, Observational data. The investigators hypothesize that they will see~     changes in self- stimulating behaviors as a result of the strategic placement of the~     ProFoveate™ pellets on the ears of one group of the participants.~   "
74055|NCT02088034|"~     The overarching goal of this project is to develop and test a behavioral intervention~     delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.~   "
74056|NCT02088021|"~     The purpose of this clinical investigation is to evaluate the use of the Portico ALC~     Delivery System to place a transcatheter aortic valve through an alternative access site,~     specifically subclavian/axillary or TAo.~   "
74057|NCT02088008|"~     A randomized, open-label, single dosing, two-way crossover clinical trial to compare the~     safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and~     Valsartan 160mg in comparison to each component coadministered in healthy male volunteers.~   "
74058|NCT02087995|"~     To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous~     monitoring system when compared to a laboratory reference measurement.~   "
74059|NCT02087982|"~     The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary~     diagnostic process to determine the medical, psychological, and functional capabilities of~     an elderly person, in order to develop a coordinated and integrated plan for treatment. It~     represents the first stage of the most appropriate care for elderly people who are frail or~     who cannot perform at least three daily tasks unaided.~      It has been shown that the integration of CGA in the decision-making and care management at~     hospital improves inpatient's health and functional status, and reduces mortality rate and~     healthcare expenditures. The effects of CGA in daily practice of general practitioners~     remain unknown.~      Implementation of a systematic CGA for every older old community-dwellers performed by a~     general practitioner remains yet difficult because of number of issues. First, although the~     number of older old community-dwellers keeps increasing, the number of health care~     professional with geriatric skills does not. Second, CGA is a complex and time-consuming~     process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone~     the care of all frail older old community-dwellers due to their limited number. An~     implication of non-geriatricians in CGA is therefore required.~      Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best~     compromise could be the use of a two-step approach. The first step is the identification by~     non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening~     tool, and the second step is a CGA by geriatricians with a diagnosis purpose.~      None of existing tools used for screening is adapted to the population of elderly people who~     visit general practitioners.Thus, healthcare professionals working in ED need a simple,~     standardized and brief geriatric assessment (BGA) to identify as soon as possible frail~     older old community-dwellers requiring specialized geriatric care.~      The investigators hypothesized that a BGA older old community-dwellers carried out by a~     general practitioner could predict the adverse health events (i.e. hospitalization,~     institutionalisation, medical consultations and death) occurring during a 6-months follow-up~     period before the evaluation.~   "
74060|NCT02087969|"~     The purpose of this study is to determine the effectiveness of dry needling in improving~     ankle range of motion and functional outcomes. There have been an increasing number of~     studies on dry needling as an intervention for pain but none thus far that have studied~     functional outcome measures of the ankle. The study will include healthy male subjects~     between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling~     of the triceps surae, triceps surae stretching only, dry needling and stretching. The~     subjects who receive dry needling as an intervention will have the trigger point identified~     and dry needling performed while under musculoskeletal ultrasound visualization. The~     subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance~     test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing~     dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale. There~     will be 3 days between the initial testing/intervention and follow up. These outcomes will~     be the primary variables of interest. Ultrasound, Y balance testing, self stretching, and~     range of motion measurements are safe and pose no risk to the subject. Dry Needling has been~     found to be very safe and effective in the hands of physical therapists with a calculated~     risk of adverse events to be less than 0.04%.~   "
74061|NCT02087956|"~     The purpose of this study is to determine whether priority-based patient navigation will~     improve patient satisfaction, quality of life (QOL), and depression when compared to~     screening-and-referral for socioeconomically disadvantaged women's health patients with~     depression. The investigators goal is to establish patient-driven, effective, generalizable,~     and disseminable interventions to reduce depression-related disparities and improve~     outcomes.~   "
74062|NCT02087943|"~     A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with~     moderate to severe atopic dermatitis~   "
74063|NCT02087930|"~     Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest~     a crucial role for enteric microflora in oral tolerance development. An altered composition~     of intestinal microflora results in an unbalanced local and systemic immune response to food~     allergens. There are qualitative and quantitative differences in gut microbiota composition~     in children with food allergy. These findings support the concept that specific beneficial~     bacteria from human intestinal microflora, designated probiotics, could restore intestinal~     microflora homeostasis and prevent or treat FA. The investigators demonstrated that it is~     possible to stimulate oral tolerance acquisition in children with cow's milk allergy using~     the most studied probiotic in the pediatric field, Lactobacillus rhamnosus GG (LGG). The~     main study aim is to identify an innovative strategy to induce oral tolerance acquisition by~     a selective manipulation of intestinal microflora.~   "
74064|NCT02087917|"~     To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density~     lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with~     primary hypercholesterolemia.~   "
74065|NCT02087904|"~     A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study~     to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of~     ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.~   "
74151|NCT02086760|"~     Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and~     scintigraphy wich is a binding exam for children. We wanted to evaluate the use of~     ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect~     which hydronephrosis need a surgery or not.~   "
74066|NCT02087891|"~     Psychosocial stress increases the risk for a multitude of diseases, including obesity,~     hypertension, and cardiovascular disease. Stress may also result in increased utilization of~     health care services. In the workplace, stress leads to emotional exhaustion, job~     dissatisfaction, lower productivity and impaired performance. Stress management programs and~     those based on mindfulness meditation have gained popularity in recent years. The purpose of~     this study is to evaluate the feasibility of an 8-week web-based mindfulness stress~     reduction program and its effectiveness in reducing work related stress and improving~     well-being in a large corporate call center.~   "
74067|NCT02087878|"~     To collect and store blood and biopsy samples obtained from CD or UC patients exposed to~     adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of~     identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.~   "
74068|NCT02087865|"~     This 24-week study will examine the sensitivity of functional MRI to detect brain changes~     caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk~     for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be~     eligible for this study. Participants without a family history of AD will also be enrolled~     to serve as a control group.~   "
74069|NCT02087852|"~     This registry will help us develop better methods of:~        -  Preventing these cancers~        -  Diagnosing these cancers~        -  Treating these cancers~   "
74070|NCT02087839|"~     Primary Objectives:~        -  To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity,~          and duration of treatment-emergent adverse events in patients with poor prognosis lung~          cancer.~        -  To record the extent, frequency and duration of any tumor responses to this treatment~          regimen and assess whether ZD6474 augments the efficacy of radiation therapy in~          non-small cell lung cancer patients.~        -  To determine the recommended phase II dose of ZD6474 for future clinical studies with~          radiation therapy.~      Secondary Objectives:~        -  To determine the effects on metabolism and angiogenic factors by positron emission~          tomography (PET) scan/computed tomography (CT) scan , Vascular endothelial growth~          factor (VEGF), and circulating endothelial cell levels in patients treated with ZD6474~          and radiation therapy.~   "
74071|NCT02087826|"~     The purpose of this research study is to examine whether specific genes (e.g. SLC16A11)~     affect how human beings respond to food and a medication that is commonly used to treat type~     2 diabetes. The food the investigators will be studying is specially prepared to contain~     protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The~     investigators hypothesize that physiological responses to the meal and to the medication~     will differ between carriers and non-carriers of genes associated with type 2 diabetes.~   "
74072|NCT02087813|"~     Neuromyelitis Optica (NMO) is a rare, devastating demyelinating disease of the central~     nervous system (CNS) that has different causes and treatments from the more common~     demyelinating disease multiple sclerosis (MS). Current NMO therapies are nonspecific and~     have varying and often suboptimal benefit. The investigators will evaluate whether use of~     alpha1-antitrypsin (A1AT, an FDA-approved medication for patients with congenital deficiency~     of A1AT associated with emphysema) can benefit acute attacks of NMO, improving patient~     disability and quality of life.~   "
74073|NCT02087800|"~     This study aims to characterize the effect of smoking on stress-induced allopregnanolone~     (ALLO) response in women by menstrual phase. The investigators hypothesize that women who~     smoke will have a blunted ALLO response to stress.~   "
74074|NCT02087787|"~     The goal of this study is to develop and test the effects of a marrow transplant (BMT) Legal~     Clinic established through a medical-legal partnership (MLP) in an adult blood and marrow~     (BMT) transplant setting. This will be a 2-arm randomized, controlled clinical trial, in~     which the intervention group of patients will participate in a BMT Legal Clinic and the~     control group is provided standard information regarding legal resources.~   "
74075|NCT02087774|"~     The investigators hypothesized that the addition of 6 minutes of exercise during the school~     day would increase physical fitness in elementary school students as demonstrated by longer~     distances run in 2 minutes and a decrease in heart rate at the end of the exercise.~   "
74076|NCT02087761|"~     The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and~     differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.~      The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.~   "
74077|NCT02087748|"~     The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel~     (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed~     Onset Muscle Soreness.~   "
74078|NCT02087735|"~     The purpose of this cross over pilot study is to investigate the urinary catabolites of~     Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.~   "
74079|NCT02087722|"~     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy~     to improve sleep quality in over 55 years old primary insomnia patients. This is a 2nd~     bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean~     patients.~   "
74080|NCT02087709|"~     The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers~     associated with insulin resistance, metabolic profile and body composition in women with~     Metabolic Syndrome.~   "
74081|NCT02087696|"~     The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as~     monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at~     24 weeks after treatment initiation.~      The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks,~     two cohorts of patients with poor compliance or with any contraindication or intolerance to~     methotrexate.~      One cohort naive to previous biological therapy and the other one treated previously with a~     biological treatment.~   "
74082|NCT02087683|"~     The purpose of this study is to determine the effects of vitamin D supplementation in~     patients with heart failure and vitamin D deficiency on ventricular function, inflammatory~     cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum~     parathyroid hormone and calcium.~   "
74083|NCT02087670|"~     Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in~     patients with chronic heart failure after participating in an exercise program and compare~     them baseline and 2 months, with another group who underwent an educational program.~   "
74086|NCT02087631|"~     Study Purpose:~      The purpose of this clinical trial is to determine if extended-release quetiapine in a dose~     of 300 mg daily is tolerable to people with relapsing remitting and progressive MS. The~     investigators will also determine if the investigators can increase the dose up to 300 mg~     daily within 3 days in people with relapsing remitting MS and within 2 weeks in people with~     progressive MS. The investigators will determine if at least two thirds of study~     participants tolerate the drug well enough to continue it for 4 weeks. Tolerance will be~     determined separately for people with relapsing remitting and progressive MS. People with~     progressive MS may be less tolerant of side effects because of greater underlying brain~     injury from MS. Alternatively, people with progressive MS may gain more benefit from the~     improved sleep that usually occurs with use of quetiapine or they may be more willing to~     tolerate some side effects. This clinical trial will determine the maximally tolerated dose~     for future trials of this drug.~      The number of participants in this study will depend on the tolerability at each dose~     tested. A maximum of 18 people with relapsing remitting MS and 18 people with primary or~     secondary progressive MS will be included.~      Study Design:~      The cohort expansion design (3+3) is used to determine toxicity-based dosing. This design is~     used in oncology phase I trials as it is guided by patient safety and minimizes the number~     of participants exposed to toxicity (Ivy et al. 2010). Maximum toxicity is defined as 33% or~     less. In this model, three patients will comprise the initial cohort. In the absence of DLT~     treatment may be escalated to the next higher dose in the next group of three patients.~     However, if one of three patients reaches DLT the cohort is expanded to six patients to~     verify that the toxicity rate has not exceeded or reached 33%. When the toxicity rate~     exceeds or reaches 33% in a cohort, this dose is deemed the maximum administered dose and a~     lower dose will be used in the next group of three patients. Patients with RRMS and~     progressive MS will be evaluated in separate groups using different dose schedules.~   "
74087|NCT02087618|"~     This is a pilot study to examine the feasibility of a formal 30-minute daily program on a~     tablet computer (simply a tablet) in subjects with mild cognitive impairment (MCI). The~     purpose of the program, known as Kodro Solution, is to increase physical activity, maintain~     social interaction, improve nutrition and exercise cognitive skills using a tablet. In~     addition to feasibility, outcome measures will include: (a) health-related quality of life,~     (b) self-esteem, (c) activities of daily living, (d) socialization, (e) mood, and (f)~     cognition. Study participants must have a study partner who can assist them with training on~     use of the tablet and the Kodro Solution program.~      Fifty (50) study subjects and their study partners will be recruited at the Wien Center. A~     delayed start design will be utilized. Study subjects will be randomly assigned to either~     active treatment (Kodro+) or delayed treatment (Kodro+D). Active treatment with Kodro~     Solution will be initiated at the baseline visit for Kodro+ subjects and 12 weeks after~     baseline for Kodro+D subjects. The 12-week period without tablets will serve as a control.~     Active treatment with Kodro Solution will continue for 36 weeks for the Kodro+ subjects and~     24 weeks for the Kodro+D subjects. For both groups, the outcome measures will be assessed at~     baseline, week 12 and week 36. The lagged design will facilitate enrollment and enable the~     assessment of a dose effect.~   "
74088|NCT02087605|"~     The objective of this work is the development and validation (reliability and validity) of~     the Automatic image analyzer to assess it retinal vessel caliber (ALTAIR) platform to~     analyze and validate its utility in different clinical settings.~      Methods / Design Design : In the first phase , will be a cross- sectional study and a second~     phase will be a prospective observational study with annual follow-up for 4 years. The study~     will be conducted in primary care including 386 subjects. Main measurements: blood pressure,~     carotid intima-media thickness using carotid ultrasound , central blood pressure and wave~     velocity pulse by SphygmoCor system, Cardio-ankle vascular index (CAVI) by VASERA® VS1500 ,~     evaluation of hypertrophy ventricular using a digital ECG and renal injury . Retinal~     vascular evaluation will be done by a non-mydriatic TOPCON TRCNW200 getting focused papilla,~     nasal and temporal and developed by software images automatically calculate the thickness of~     the retinal vessels , the arteriovenous index, the vascularized area and branching pattern .~     For validation software retina intra and inter - observer variability , the correlation of~     the tool measurement with AVindex , and concurrent validity with parameters of vascular~     structure and function and target organ damage and association analysis will analyze the~     different parameters of the estimated retina and evolution or appearance of new lesions in~     the target organs.~      Discussion The validation of the tool contribute to the analysis of retinal vessels improved~     reliability by reducing the intervention of the observer and further validate the use of~     more information than the previously used , especially surface vascularization and vessel~     branching patterns .~   "
74089|NCT02087592|"~     BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian~     cancer during their lifetime. There is evidence from the literature that for sporadic breast~     cancer disease risk and the course of disease can be significantly influenced by physical~     activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized~     multicenter feasibility trial is that a structured life-style intervention program with~     exercise training and mediterranean diet is feasible and improves the nutritional and~     fitness status as well as the weight, the quality of life and stress reacting capacity.~   "
74090|NCT02087579|"~     The purpose of this study is to gather information about the steady-state plasma~     concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at~     various dose levels and at different time points after dosing. In addition, comparison of~     capillary drug concentrations vs. venous drug concentrations will be performed for~     aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant~     metabolites.~   "
74091|NCT02087566|"~     Renal failure patients were treated with linezolid (LZD) for proven or suspected infections~     by multiresistant Gram-positive cocci. The aim of this study is to determine if dose~     adjustment of LZD is needed as a function of renal impairment or not, especially that a~     significant component of LZD is eliminated unchanged in urine.~   "
74092|NCT02087553|"~     The investigators hypothesize that the storage-damaged red cells are responsible for some of~     the adverse effects of transfusion. In this observational study, the investigators will~     measure various laboratory parameters both before and after transfusion in a pediatric~     intensive care unit to determine at what duration of storage is there laboratory evidence of~     refrigerator storage damage.~      The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs)~     transfused will be associated with increasing non-transferrin-bound iron (NTBI),~     pro-inﬂammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric~     patients.~   "
74093|NCT02087540|"~     To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in~     hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each~     monotherapy.~   "
74094|NCT02087527|"~     The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to~     antibiotic treatment during the first 48 hours of admission to the hospital in patients with~     cellulitis and its impact in the duration of the stay.~   "
74152|NCT02086747|"~     The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent~     chronic pain in hysterectomy patients.~   "
74096|NCT02087501|"~     Clinical Investigation Design A prospective, open-label, non-randomized, interventional~     clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.~      Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its~     designated Delivery System.~      Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™~     AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac~     aneurysms. The results of this study will be used as supportive data for CE Marking~     submission in the European Union (EU).~      Objectives The primary objectives of the study are to evaluate the safety and performance of~     the Horizon™ AAA Stent graft System.~      Primary End Points Safety endpoints include proportion of patients free from device related~     Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance~     endpoints include successful delivery and deployment of the device; and absence of the~     following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft~     occlusion, conversion to open surgery, rupture and stent graft migration.~      Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac~     aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular~     access techniques and devices.~      Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic~     Aneurysm Stent graft System.~   "
74097|NCT02087488|"~     This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular~     acupuncture(AA) for primary insomnia(PI) .~   "
74098|NCT02087475|"~     Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although~     multiple treatment modalities including surgery, radiotherapy and chemotherapy have been~     developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable~     advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus~     adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase~     III mode.~   "
74099|NCT02087462|"~     This multicenter randomized controlled trial (RCT) will evaluate the therapeutic~     effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral~     disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus~     traction, electroacupuncture plus traction and medication.~   "
74100|NCT02087449|"~     Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population~   "
74101|NCT02087436|"~     The primary purpose of this study is to measure the postoperative changes in bone mineral~     density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard~     length Taperloc Complete Reduced Distal stem.~   "
74102|NCT02087423|"~     A study to assess the Effects of MEDI4736 in Patients With Locally Advanced or Metastatic~     Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability~   "
74103|NCT02087410|"~     measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy~     levels~   "
74104|NCT02087397|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the~     corpus cavernous in patients with Erectile Dysfunction.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Erectile Dysfunction.~   "
74105|NCT02087384|"~     This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo~     vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex~     with men) who were successfully treated for high grade AIN.~   "
74106|NCT02087371|"~     This is a prospective, multicenter, non-interventional, observational study of a cohort with~     a biological plasma and urine samples collection for the study of prognosis factors of~     cardiac complications after liver transplantation~   "
74107|NCT02087358|"~     This 3 weeks study examines the correlation between stress and alcohol using an ecological,~     prospective design.~   "
74108|NCT02087345|"~     Dental erosions, the chemical dissolution of enamel without bacterial involvement, are~     considered to be an established complication of gastroesophageal reflux disease (GERD) by~     the Montreal global consensus statement. Given the high prevalence of dental erosions and~     the absence of any pH-impedance data or medical management guidelines for GERD-associated~     dental erosions, reflux characteristics will be characterized using questionnaires,~     endoscopy and esophageal pH-impedance testing, in successive patients dental erosions~     referred by dentists for evaluation of GERD. For assessment of the role of additional~     factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated~     during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors~     for progression of dental erosions will be determined by repeating the evaluation after~     chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.~   "
74109|NCT02087332|"~     Study hypothesis is that the time from randomization to the increase of natriuresis (%),~     time to standardization of natriuresis daily profile, blood pressure profile and the~     percentage reduction of central hemodynamic parameters will be relatively changed over the~     study period by more than 15%.~   "
74110|NCT02087319|"~     The purpose of study is to examine the advantage of PRP on hair loss and male pattern~     baldness. The investigators will inject PRP into the scalp regions where with little or no~     hair, and evaluate the effect and efficiency of PRP on human hair growth.~   "
74111|NCT02087306|"~     This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)~     for the treatment of AdV infection detected during asymptomatic AdV viremia or during~     symptomatic AdV infection. After completing a screening assessment to confirm study~     eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on~     Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will~     receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2~     mg/kg BIW, not-to-exceed a total dose of 200 mg/week.~   "
74112|NCT02087293|"~     Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the~     safety and effectiveness of treatment for patients taking FDA-approved medications for one~     of four common chronic conditions (diabetes, hypertension, insomnia, depression), with~     integrated management support by a pharmacist.~      Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this~     integrated module for adult primary care patients in the Brigham and Women's Primary Care~     Practice-Based Research Network.~   "
74113|NCT02087280|"~     After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require~     re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as~     lack of the patient's compliance and motivation to recover. However in studies,~     psychological relapse predictors explain only a minor part of the variance in relapse risk.~     Metabolic phenotyping has clinical value to predict weight course in obese patients and we~     assume that it could also be clinically relevant in patients with AN. We hypothesize that in~     patients with a dissipative but not with the thrifty phenotype, positive energy balance~     during refeeding causes an over proportional rise in energy expenditure, counteracts~     continuous weight gain during inpatient treatment, and increases relapse risk within one~     year after discharge. Thus we believe that metabolic phenotype as a biological parameter has~     prognostic value for the disease course in AN.~   "
74114|NCT02087267|"~     The objective of the PMCF is to collect outcome information on patients suffering from~     symptomatic degenerative disc disease or degenerative spondylolisthesis requiring 1- or~     2-level lumbar or lumbar-sacral spinal fusion with posterior instrumentation and therefore~     receiving the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage~     ETurn™.~   "
74115|NCT02087241|"~     The aim of this study is to combine AZD1775 with standard front-line chemotherapy in~     subjects with advanced NSCLC.~   "
74116|NCT02087228|"~     The purpose of this study is to evaluate the shape, size and appearance of the inside of the~     uterus six months following an endometrial ablation procedure. Half of the participants will~     have their ablation performed with a hydrothermal ablation device and the other half will~     have their ablation performed with a device that uses radiofrequency energy.~   "
74117|NCT02087215|"~     Boron as a naturally occurring element has some metabolic and inflammatory actions. The~     antibacterial activity against gram negative bacteria is also known. Boron deficiency is~     shown to be related with impaired wound bone healing in rats. Therefore, special wound care~     formulas containing boron may have some positive effect on wound healing of the patients~     with diabetic foot ulcers.~   "
74118|NCT02087202|"~     NMDA receptor is administered and postoperative remote hyperalgesia is investigated.~   "
74119|NCT02087189|"~     This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD~     lead.~   "
74120|NCT02087176|"~     A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus~     antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell~     Lung Cancer Patients~   "
74121|NCT02087163|"~     The purpose of this study is to use clear aligners to measure tooth movement and length of~     treatment.~   "
74122|NCT02087150|"~     The objective of this study is to determine whether Eustachian tube dilation in conjunction~     with medical management or medical management alone is effective for treating Eustachian~     tube dysfunction.~   "
74123|NCT02087137|"~     Normal aging is associated with decline in some aspects of memory, and this can be a risk~     factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches~     positive adaptation to age-related memory changes, including strategies for minimizing the~     everyday impact of normal memory change and positive lifestyle change to maximize brain~     health. Prior research has shown that the Memory and Aging program is effective in~     increasing participants' knowledge about memory, use of memory strategies, and confidence in~     memory function, as well as adoption of healthier lifestyle practices and reduction in~     intention to use unneeded health care resources.~      Although not one of the stated goals of the program, informal feedback from participants~     suggests that the educational content and skills training in the Memory and Aging Program~     has led some participants to change behaviours in ways that lead to significant improvements~     in their everyday functioning. For example, graduating participants often volunteer examples~     of how they have applied what they have learned to succeed in everyday memory tasks such as~     learning a new name or keeping track of future plans. Based on this participant feedback, it~     is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging~     Program participants may lead to positive behaviour changes that, in turn, lead to improved~     everyday functioning. The present study will test this hypothesis using a randomized~     controlled pretest-posttest design.~   "
74124|NCT02087124|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate if there is a dose-response effect of whey protein~     consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and~     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,~     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying~     and metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein (10 or 20g) consumed 15 minutes prior to a~     fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a~     dose-dependent way compared to placebo (water) consumed prior to the meal in subjects with~     MeS.~      The investigators research will hopefully contribute to a better understanding of how PPL~     can be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular.~     Thus, the results of this project can impart knowledge of great importance both to the~     national and international food industry as well as the healthcare systems.~   "
74125|NCT02087111|"~     Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very~     high chance of developing fatal complications of their disease unless they receive effective~     treatment. Unfortunately the best drugs that are currently available to treat genotype 3~     hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with~     advanced liver disease and therefore a large number of patients who have failed treatment~     are waiting for new, better drugs. Currently there are no treatments available for these~     patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and~     which works very well in these patients. In patients with genotype 3 hepatitis C small scale~     trials and laboratory studies show that some patients do respond quite well and others~     respond a little bit when given telaprevir. In patients who have exhausted all other~     treatment options the investigators speculate that telaprevir treatment may help some~     patients by clearing their infection. The purpose of this study is to see if telaprevir can~     help these patients and to determine if the investigators can predict in advance which~     people can be helped.~   "
74126|NCT02087098|"~     This is a 12 month non-interventional study with solifenacin succinate, evaluating the~     effect of solifenacin on quality of life (QoL) of patients previously treated with~     antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their~     treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by~     Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on~     quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group~     scoring system (EQ-5D-5L).~   "
74127|NCT02087085|"~     This study will assess the safety and efficacy of the brimonidine intravitreal implant in~     patients with geographic atrophy due to age-related macular degeneration.~   "
74128|NCT02087072|"~     The primary objective is to develop a sustainable practice model emphasizing home visits by~     a collaborative physician and pharmacist team to decrease unplanned emergency department~     visits and hospital readmissions at 30 and 90 days for high-risk home bound patients.~     Secondary objectives include (1) tracking the number, type, and severity of adverse drug~     events (ADE) and potential adverse drug events (pADE) that occur following hospital~     discharge and (2) resolving any identified ADE and pADE within 7 days of hospital discharge.~      Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at~     the time of hospital discharge. The home visit will occur within 7 days of hospital~     discharge and will consist of a complete hospital and medication review by a physician or~     nurse practitioner and a pharmacist (including all lab tests, imaging studies, medication~     changes, and proposed plan of care at the time of discharge). The investigators hypothesize~     these home visits will reduce 30 and 90 days hospital readmission rates and ED visits.~      The number of emergency department visits and unplanned hospital readmissions will be~     tracked at 30 and 90 days following discharge from the hospitalization that led to study~     enrollment. A comparison cohort of patients discharged in the 12 months prior to study~     initiation will be used to compare the effectiveness of the home visit program. The number~     and type of adverse drug events (ADE) and potential adverse drug events (pADE) that occur~     during transitions of care will also be characterized. All ADE and pADE will be resolved~     during the initial home visit and will be classified based on severity. All ADE and pADE~     will be evaluated independently by two pharmacist reviewers; each reviewer will~     independently assign a severity rating to each ADE and pADE.~   "
74129|NCT02087059|"~     This is an open-label, multicenter clinical study in order to collect and examine data~     concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis~     (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.~   "
74130|NCT02087046|"~     The purpose of the proposed study is to demonstrate the safety and efficacy of the Totally~     Implantable Deep Brain Stimulation System in the ventral intermediate (VIM) nucleus of the~     thalamus implanted for the treatment of tremor due to essential tremor. This study will be~     included in the Pre-Market Approval Application to support the safety of this device in use.~   "
74131|NCT02087033|"~     it is a prospective, randomized, double-blinded, crossover study on the use of an~     association of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in~     subject affected by symptomatic supraventricular ectopic beats without structural heart~     disease.~      The study will evaluate the reduction of the number of supraventricular ectopic beats and~     symptoms related.~   "
74132|NCT02087020|"~     Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after~     knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is~     recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success~     rate of DAIR in early infections and to identify predictors for success. Material and~     methods: In a retrospective cohort study we included patients with hip- or knee~     arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic~     regression analysis was used to identify risk factors affecting success rate. Primary~     outcome variable was the success of the DAIR treatment. Secondary outcome variable vas risk~     factors for treatment failure.~   "
74133|NCT02087007|"~     This study will be conducted in accordance with the local regulation of New Drug~     Application. Overall duration of this trial will be 3 years after approval of KFDA.~      Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in~     period, 4 weeks double blind period and 1 week safety follow up period~   "
74134|NCT02086994|"~     We aim to compare carbetocin with misoprostol for the prevention of postpartum hemorrhage in~     patients with severe preeclampsia. The primary outcome is postpartum haemorrhage (blood loss~     of ≥ 500 ml) while our Secondary outcomes include use of additional uterotonics, need for~     blood transfusion, maternal adverse drug reaction, maternal complications and maternal death~   "
74135|NCT02086981|"~     Primary objectives are to define incidence and prevalence of Delirium in an elderly~     population admitted to the Department of Orthopedics and Traumatology and, in the~     postoperative phase, in the high Dependency Unit as well as to determine the presence of~     risk factors. Secondary objectives are to determine mean hospital stay, rates of~     complications as well as in-hospital mortality and at 1-3 and 12 months after discharge,~     functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.~   "
74136|NCT02086968|"~     The primary objective of this study is to evaluate the treatment response of Injectafer vs.~     oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric~     Bypass patients may demonstrate to be inappropriate for oral iron therapy.~   "
74137|NCT02086955|"~     The purpose of the study is to evaluate the effectiveness of a nurse led intervention for~     high risk patients with diabetic foot ulceration and/or amputation.~      The effectiveness is defined in two ways 1) as a reduction in complication rates (time till~     ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in~     hospital readmissions for foot-related complication (one year survival probability: failure~     = readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).~   "
74179|NCT02086396|"~     This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour~     consumption on diet improvement, weight loss, and glucose and cholesterol reduction in~     obese.~   "
74366|NCT02083939|"~     The purpose of this study is to find out whether it is necessary to prophylactically treat~     patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is~     that it is not necessary to pretreat patients with antibiotics if the operation is minimally~     invasive with a mesh placed at the defect.~   "
74138|NCT02086942|"~     This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to~     August 2017.Firstly, All patients included will provide written informed consent. Secondly,~     they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD~     regimen arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment~     consists of four 4-week cycles of induction therapy followed by intensive therapy with~     another five modified VCD regimens and maintenance treatment with CP regimen. Then, patients~     will be followed up for 24 months after chemotherapy. The investigators will record all the~     laboratory and clinical investigations to assess response at different points of the study.~     We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version~     3.0.Response categories were based on the International Myeloma Working Group uniform~     response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen~     arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.~   "
74139|NCT02086929|"~     The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine~     extended release (venlafaxine XR) after an 8-week treatment period in patients with major~     depressive disorder.~   "
74140|NCT02086916|"~     Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when~     susceptible patients receive antibiotics as part of their (often life-saving) care. The~     commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third~     of us but causes no problems. Rates of infection had been falling with increased awareness~     and improved hygiene but they are starting to creep up again. Clostridium difficile can~     cause a range of disease from a short-lived mild diarrhoea to severe disease of the bowel~     with major effects on the whole body and even death.~      This study aims to identify substances in the stool and in the blood to enable doctors to~     predict how severe that individual's disease will be. These tests can easily be performed.~     If they prove accurate in identifying the subsequent severity of the patient's illness due~     to Clostridium difficile, patients predicted to develop the worst disease can receive the~     most intensive treatments before they become too unwell to benefit. On the other hand,~     patients whose disease is predicted by these markers to run its course without causing~     serious consequences can be spared the side effects and risks of more intensive treatment.~   "
74141|NCT02086903|"~     To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers~     compared with standard Clopidogrel agent.~   "
74142|NCT02086890|"~     Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no~     proven treatment. Patients are interested in trying alternative therapies to try to reduce~     their vision loss, but only limited research evidence exists to support their use and~     potential benefit. The goal of this research project is to gain a better understanding of~     possible changes in ocular and retinal blood flow and measures of vision in RP patients~     receiving two promising therapies, electroacupuncture and transcorneal electrical~     stimulation.~   "
74143|NCT02086877|"~     As survival rates from critical illness improve, strategies to return patients to their~     baseline cognitive and functional status are important research priorities. Up to 100% of~     ICU survivors will suffer some degree of cognitive impairment at hospital discharge and~     approximately 50% will have decrements that persist for years. While the mechanisms for this~     newly acquired brain injury are poorly understood, several risk factors have been~     identified. Unfortunately, it is unclear how to accurately predict long-term cognitive~     impairment.~      Immediate opportunities to improve cognitive outcomes through risk reduction exist. The~     investigators propose to comprehensively study the prevalence of sleep abnormalities and~     their association with cognitive impairment, as it may yield potential targets for effective~     therapy. Moreover, the investigators will examine for gene x environment associations [APOE~     ε4] that may allow for genetic risk stratification of individuals at greatest risk of~     cognitive impairment. The investigators hypothesize that EEG [a sensitive longitudinal~     marker of brain dysfunction] is a novel and independent predictor of long-term cognitive~     impairment, and possibly a candidate intermediate end point for future clinical trials.~      This study has the potential to identify novel biomarkers and risk factors for post-critical~     illness cognitive impairment, and may lay the foundation for rational interventions to~     mitigate risk in high-risk individuals.~   "
74144|NCT02086864|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents~     during childhood, with at least some symptoms causing impairment before the age of seven. It~     is characterized by developmentally inappropriate levels of inattention and/or~     hyperactive-impulsive behavior, with significant impairment occurring in at least two~     settings. It affects approximately 5.2 million children in the United States. Homeopathic~     treatment has been shown to be a promising intervention for ADHD, however the reasons for~     that effectiveness is unclear. Specifically, it is unclear whether improvement is due to the~     homeopathic medicine, the consultative process, or other non-specific effects.~      This study has 3 primary objectives: 1. to determine if there are any specific effects of~     homeopathic medicines in the treatment of ADHD, 2. to determine if there any specific~     effects the homeopathic consultation alone in the treatment of ADHD, and 3. to determine if~     there is an overall effect of homeopathic treatment (homeopathic medicines plus~     consultation) in the treatment of ADHD.~      This is a three arm study. Participants will be randomized to one of three arms:~      Arm 1 (Verum group): a treatment arm where the participant will receive homeopathic~     consultation plus a homeopathic remedy Arm 2 (Placebo group): a treatment arm where the~     participant will receive homeopathic consultation plus a placebo remedy Arm 3 (Usual care~     group): participants will continue with usual care and will not receive homeopathic~     treatment as part of the study.~      Participants enrolled in this study, regardless of which study Arm they are in, may continue~     with all conventional medications or any other aspect of their current standard of care they~     are taking as recommended by their usual physician (so long as they are on a stable dose of~     the conventional ADHD medication for at least 6 weeks prior to beginning the trial). They~     may also continue to attend regularly scheduled visits with their own health care~     practitioner(s).~      Participants may also start, stop or change the dose of any therapy (including conventional~     medications) during the study and are asked to report the change to the study team. Thus,~     the placebo group participants are not different than other participants, except that they~     will have a homeopathic consultation and a placebo remedy. The use of placebo is specific to~     homeopathic treatment, to allow for double-blinding, which is recognized to reduce study~     bias.~      Prior to enrolling in the study, those considering participation will undergo a full~     assessment by a psychiatrist with a specialty in child and youth mental health. This~     assessment confirms the diagnosis and screens for inclusion/exclusion study criteria. At the~     same time, the psychiatrist recommends evidence-based therapies to clients including~     conventional medication. The psychiatrist does not directly treat the client. If medication~     is recommended and the clients wish to pursue it with their regular physician, they would~     still be able to enroll in the study if they wanted to, after six weeks of reaching a stable~     dose.~      This study will help our understanding of the treatment process and whether different~     elements of the intervention have greater or lesser effects.~      This study is a follow-up to an open label pilot study of the homeopathic treatment of ADHD~     using the same study team. Sample size was calculated based on the results of that study.~   "
74145|NCT02086851|"~     The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle~     modification program focusing on dietary modification and exercise. Parents will be~     randomized into control and motivational interviewing-based intervention groups. The primary~     hypothesis is that adolescents whose parents are in the intervention group will have~     improved compliance, weight loss and health outcomes compared with adolescents whose parents~     do not receive the intervention.~   "
74146|NCT02086838|"~     Evaluate the effect of iron supplementation using oral routes in comparison with total dose~     infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.~   "
74147|NCT02086825|"~     The aim of the current study is to determine whether rifaximin or lactulose is more~     effective in preventing the development of severe hepatic encephalopathy in hospitalized~     patients with cirrhosis and new onset kidney failure.~      Subjects will be randomly assigned to one of two treatment groups:~      Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B:~     Rifaximin 550mg tablet twice daily.~      Subjects will be followed daily for two weeks or until hospital discharge. Treatment success~     is defined as prevention of grade 3 or 4 HE during hospitalization.~   "
74148|NCT02086799|"~     This study will explore whether supplementation with thyroid hormones in the set-up of~     asthma exacerbation could improve the clinical outcomes.~      The study will include adults admitted to Rambam health care campus for moderate to severe~     Asthma exacerbation.~      The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial.~     Patients will be randomized on admission to receive treatment with intra-venous thyroxine~     (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study~     treatment will be given only after the initial bronchodilator therapy, oxygen and informed~     consent are given. The primary endpoint is the time to return of the peak expiratory flow~     (PEF) rate to normal values or personal base line.~   "
74149|NCT02086786|"~     To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting~     formulation (in situ microparticle, ISM) of risperidone over four IM injections in the~     gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients~     with schizophrenia.~   "
74153|NCT02086734|"~     The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT)~     for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC)~     undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.~      In this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT~     scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT~     start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected~     intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT.~     Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions~     will be quantified and correlated with patient outcome.~   "
74154|NCT02086721|"~     The formation of metastasis is responsible for as much as 90% of cancer-associated~     mortality. In spite of recent advances in oncologic therapy, approximately 50 % of the lung~     cancer patients have already overt disseminated cancer at diagnosis. Additionally, numerous~     patients with locoregional disease initially treated with curative intent develop~     (oligo)metastases during the course of disease. In both instances, these stage IV patients~     are generally considered to be incurable and mostly treated palliatively.~      Oligometastases, defined as 1-5 sites of active disease on whole body imaging, was coined to~     refer to isolated sites of metastasis resembling limited tumor metastatic capacity. The~     implication of this concept is that local cancer treatments are curative in a proportion of~     patients with metastases and that incorporating local therapy is a conceptually attractive~     approach. In several, but not all, academic centers the standard treatment of patients with~     oligometastases in good general health is standard chemotherapy followed by surgery or by~     Stereotactic Ablative Body Radiotherapy (SABR) with radical dose on the macroscopic visible~     tumors.~      The widespread introduction of SABR and of minimally invasive surgery has fuelled research~     in treating patients with oligometastases. Indeed, local control of metastases can be~     obtained in virtually all parts of the body with a low proportion of patients experiencing~     severe side effects. In the few prospective studies published to date, approximately 20% of~     patients remained free of recurrence several years after treatment when all sites of disease~     were targeted by radiation.~      Along with standard anti-cancer therapeutic modalities like chemotherapy and radiotherapy~     (RT), immunotherapy has recently gained a lot of attention.~      Angiogenesis is one of the hallmarks of cancer, and therefore, considerable efforts have~     been made to exploit this unique target for selective drug delivery. One of the appealing~     targets for both approaches is the splice variant of fibronectin containing extra domain B~     (EDB), which is abundantly expressed in vascular endothelial cells of a variety of primary~     tumors as well as metastases , but virtually absent in normal tissues. Recently, a human~     recombinant scFv fragment directed against EDB, designated L19, was developed and~     subsequently combined with the pro-inflammatory interleukin-2 (IL2), resulting in the~     immunocytokine L19-IL2. L19-IL2 delivers high doses of IL2 to the (metastatic) tumor site(s)~     exploiting the selective expression of EDB on newly formed blood vessels. Interleukin-2~     (IL2) plays an essential role in the activation phases of both specific and natural immune~     responses. Even though it has no direct cytotoxic effects on cancer cells, it can induce~     tumor regression by stimulating a potent cell-mediated response. In summary, L19-IL2 is an~     immunocytokine which will stimulate immune response specifically in tumors with angiogenesis~     and tissue remodeling.~      Radiotherapy is a particularly interesting partner for immunotherapy, since it can be~     harnessed to specifically modify the immunogenicity of the primary tumors and their~     microenvironment, in the attempt to generate an in situ immunization of the host against a~     patient's own cancer. Our hypothesis is that three independent therapeutic approaches will~     synergize to improve dramatically survival in patients with oligometastases of solid tumors.~   "
74155|NCT02086708|"~     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate~     quantitative measurements that can be used to stage liver fibrosis in pediatric patients~     with chronic liver disease.~      Specific Aims:~      To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect~     diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine~     clinical care.~   "
74156|NCT02086695|"~     The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and~     novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or~     administer prophylactic cardioprotective agents, prior to the development of irreversible~     cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will~     be able to accurately detect subtle cardiac injury at a time when conventional Left~     Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated~     cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT)~     testing can detect early BVZ or Sunitinib mediated endothelial dysfunction.~   "
74157|NCT02086682|"~     The introduction of unfractionated heparin (UFH), which prevents clotting of the~     extracorporal circuit, was one of the key advances that led to the rapid development and~     expansion of hemodialysis services. However, anticoagulation during hemodialysis of the~     patient at high risk for bleeding remains a frequently encountered problem in both inpatient~     and outpatient dialysis practice.~      Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help~     reduce heparin use and decrease clotting rates. The goal of this study is to prospectively~     examine impact of the Streamline airless blood tubing set, in an inpatient setting, on~     dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.~   "
74158|NCT02086669|"~     Patients with newly diagnosed achalasia have been submitted to either treatment with~     pneumatic dilatation or surgical myotomy. Minimal follow up five years.~   "
74159|NCT02086656|"~     Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of~     borderline and/or high risk resectable colorectal cancer liver metastases~   "
74160|NCT02086643|"~     The goal of this study is to determine the success rate of the retroclavicular approach for~     the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)~   "
74161|NCT02086630|"~     This study addresses racial/ethnic disparities in HIV/AIDS treatment. Many persons living~     with HIV/AIDS (PLHA) in the U.S. (10-19% of PLHA), predominantly African-Americans and~     Latinos, delay taking Highly Active Antiretroviral Therapy (HAART) until late in the course~     of their HIV disease or never initiate HAART when it is medically indicated. However, there~     are no behavioral interventions to increase HAART initiation among PLHA who delay or decline~     HAART (PLHA-DD). The overarching aim of the proposed study is to develop a flexible,~     targeted, and sustainable behavioral intervention to increase HAART initiation among~     PLHA-DD, which, if efficacious, will lead to reductions in morbidity, early mortality, and~     health care costs, as well as increased viral load suppression (reducing transmission to~     others). Further, the study complements and primes participants for existing adherence~     interventions, from which PLHA-DD can benefit when they initiate HAART.~   "
74162|NCT02086617|"~     The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA)~     among male patients with coronary artery disease (CAD). Secondary purpose is to document~     cost-effectiveness of ultrasound screening of AAA in selected population.~      Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the~     basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems~     to be higher in CAD population than unselected male population. This leads to hypothesis~     that selective screening of these patients (for AAA) could be cost-efficient and life saving~     option for detecting AAAs before rupture.~      Study will be carried out as a single-center prospective screening study. Patients will be~     selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient~     information system. Inclusion criteria will be any kind of atherosclerotic heart disease~     (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or~     treated AAA and failure to give informed consent.~      800 patient records that meet the inclusion criteria will be reviewed for eligibility.~     Invitations for screening will be sent for 600 patients with intention to have at least 400~     patients screened. Screening will be done by verified sonographers in designated screening~     appointments.~   "
74163|NCT02086604|"~     This Phase I clinical trial studies the side effects and maximum tolerated dose (MTD) of the~     combination of brentuximab vedotin (BV) and lenalidomide in the treatment of patients with~     relapsed or refractory diffuse large B-cell lymphoma (DLBCL).~   "
74164|NCT02086591|"~     The purpose of this study is to determine whether doxycycline is effective in the treatment~     of relapsed Non Hodgkin Lymphomas (NHL).~   "
74165|NCT02086578|"~     The purpose of this study is to determine if a radiation treatment called Multi-beam~     Intensity Modulated Radiation Therapy(IMRT) can reduce side effects related to your implant~     if they are a candidate for radiation therapy. Currently, the standard method of giving~     radiation is with 3D radiation, which only uses 2-5 beams of radiation. Multi-beam IMRT~     works by using 8-12 small radiation beams to give a more tailored or customized~     radiation dose to the implant, breast, chest wall and lymph nodes. At the same time,~     multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal~     of the study is to reduce complications after irradiation to the implants.~      The study doctors have recently completed a trial using this technique and are now~     specifically looking at its impact on women with implant reconstructions who are undergoing~     post-mastectomy radiation therapy. By delivering a more customized dose of radiation to~     the implant, the intent is to reduce side effects of radiation on the implant.~   "
74166|NCT02086565|"~     Background: Asthma morbidity is high in inner-city minority adults, despite the existence of~     efficacious therapy. Tailored, patient-centered interventions are needed to improve access~     to care and patient-provider communication. Access and communication increasingly rely on~     information technology (IT) as new incentives arise to use the Electronic Health Record~     (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and~     practices. How the poor and those with limited educational opportunities can take advantage~     of these is unclear. In contrast, the investigators have found that home visits (HVs) by~     community health workers (CHWs) can improve access to care for children and promote~     caretaker-clinician communication. The investigators also found many inner-city adults have~     internet access and are willing to learn to use the PP.~      Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs~     who will encourage/facilitate PP use, understand patients' social context, and enhance~     communication with the medical team. The investigator hypothesize all patients will benefit~     from PPs, and that the addition of HVs will be particularly helpful for those with low~     literacy or language barriers. Specific Aims test if the 1-year interventions result in 1)~     better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more~     communication (use of PP) and access (appointments made and kept) which mediate the~     interventions' effects on asthma outcomes, and 4) effect modification by literacy level,~     primary language, and convenience of internet access.~      Methods: In a randomized controlled trial, 300 adults, predominantly African American and~     Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will~     be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs~     will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a~     view of the complex social circumstances of patients' lives to providers, and 4) make up for~     differences in patients' health literacy skills.~      Patient Outcomes are asthma control, asthma-related quality of life, emergency department~     (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health~     conditions affect patients' ability to perform their daily tasks and care for their~     families. Potential benefits of the intervention are enhanced patient-clinician~     communication, access to care, improved health, and ability to use IT.~   "
74167|NCT02086552|"~     This phase II trial studies how well sonidegib and lenalidomide after stem cell transplant~     works in treating patients with multiple myeloma. Sonidegib and lenalidomide may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay~     multiple myeloma from coming back after a stem cell transplant.~   "
74168|NCT02086539|"~     This study aims to determine the effectiveness of 4 different recruitment techniques for~     enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for~     the study will be randomized into one of 4 groups and will all receive the same recruitment~     letter inviting them to participate in the study by enrolling on an online platform. Group 1~     will receive the recruitment letter in a normal sized envelope, Group 2 will receive the~     recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter~     shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the~     image of an Amazon gift card and told they will receive a $25 gift card if they enroll in~     the study. All other groups are told that they will receive a $25 check upon enrollment in~     the study.~   "
74169|NCT02086526|"~     The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can~     be separated into subtypes based on their response to metformin. The investigators propose~     here to use both targeted and non-targeted metabolomic approach to identify pathways~     associated with metformin's effect on insulin sensitivity and endothelial function. This~     pilot project will be the foundation for developing tailored therapeutic approaches to~     Polycystic Ovary Syndrome and identifying novel drug targets.~   "
74170|NCT02086513|"~     This is a phase I trial of LDE225 for the treatment of steroid-refractory chronic Graft~     Versus Host Disease (GVHD).~   "
74171|NCT02086500|"~     The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given~     during air medical transport to a level 1 trauma center in patients at risk of hemorrhage is~     associated with lower 30 day mortality.~   "
74172|NCT02086487|"~     whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response~     in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor~     response compared to conventional cytogenetics on bone marrow (BM) sample~   "
74173|NCT02086474|"~     The objective of this study is to assess the changes in daily physical activity and gait~     pattern, following a viscosupplement injection among a population who is suffering from hip~     osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a~     functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36~     (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology~     affects the quality of life, will be use.~   "
74174|NCT02086461|"~     Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem.~     No treatment is currently available. It can be hypothesized that incomplete relaxation of~     the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may~     therefore be a potentially effective treatment.~   "
74175|NCT02086448|"~     The purpose of this study is to better understand how sleep apnea, a common sleep disorder~     in which a person has one or more pauses in breathing or shallow breaths while sleeping, may~     affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP),~     a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant~     women with sleep apnea.~   "
74176|NCT02086435|"~     The aim of this study protocol will be to compare the technique of intracorporeal~     morcellation using reusable electronic device (standard technique) with a technique of~     removal protected by endobag and extracorporeal myoma morcellation with cold scissors and~     scalpel blade or with power morcellator used inside the bag itself.~   "
74177|NCT02086422|"~     Patients with CHF benefit from heart rate lowering, and the investigators have previously~     demonstrated that this does not adversely affect exercise tolerance. In a pacemaker~     population we also have shown that preventing heart rate lowering is detrimental in terms of~     symptoms and prognosis.~      The aim of the study is to therefore to establish whether heart rate limitation in patients~     with heart failure has a negative impact on exercise capacity. If the investigators~     establish that this is not the case, physicians will be able to confidently prescribe heart~     rate lowering agents, and programme pacemakers to allow bradycardia without the concern that~     there will be detrimental effects of symptom.~   "
74178|NCT02086409|"~     Gait and posture disorders are very common in subjects aged 65 and over, and result mainly~     from neuromuscular and cognitive disorders.~      Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and~     over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive~     performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the~     intake of vitamin D combined or not with calcium may improve muscle strength and cognitive~     performance.~      The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of~     vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and~     executive performance, 2) and that this improvement depends of the initial level of vitamin~     D deficiency.~   "
74180|NCT02086383|"~     The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is~     effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in~     patients with chronic obstructive pulmonary disease (COPD).~      PR is an evidence-based multidisciplinary approach consisting primarily of a supervised~     exercise program with educational components. It has demonstrated high efficacy in improving~     dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in~     patients with COPD. Despite these improvements, there is no conclusive evidence that these~     benefits translate to an increase in PA in patient's day-to-day life. This is of concern as~     low PA is a predictor of all cause mortality, correlated with lower HRQoL, increased level~     of dyspnoea and higher number of hospital admissions in this group of patients.~      Self-efficacy is found to be an instigating force in forming intention to exercise and in~     maintaining practice for an extended time. Self-efficacy may be the key in determining~     whether a patient translates the improvement in exercise tolerance to actually being more~     physically active. Based on current knowledge, there is insufficient evidence that~     self-efficacy increases after pulmonary rehabilitation and no correlation has been made~     between level of self-efficacy and level of PA in these group of patients.~      Hence this study aims to find out whether the existing PR program increases level of PA and~     self-efficacy. Correlation between level of PA and self-efficacy will be made.~   "
74181|NCT02086370|"~     The aim of this RCT of study is to compare the outcomes of the standard salpingectomy~     (removal of the fallopian tube) with the radical removal of the tube and the mesosalpinx in~     terms of ovarian reserve.~   "
74182|NCT02086357|"~     Ultrasound (US)tissue elastography has recently been found to have a number of clinical~     applications in the assessment of soft tissue disease for example, in breast and thyroid~     pathology. There are few current studies exploring its use in musculoskeletal pathology,~     particularly a new technique called sheer wave ultrasound elastography (SWUE).~      Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics,~     sports medicine and rheumatology and SWUE may have the potential to also demonstrate~     clinical effectiveness in these areas.~      Our aim is to explore the effectiveness of this technique in the assessment of~     musculoskeletal pathology.~      Participants will be recruited through current referral protocols and would undergo an~     additional elastographic investigation in addition to their standard US examination. This~     investigation will be conducted within the musculoskeletal US department at Chapel Allerton~     Hospital by trained musculoskeletal specialists. The study will be conducted over a period~     of approximately 24 months with quarterly review during this time.~   "
74183|NCT02086344|"~     The aim of this RCT of study is to compare the standard TLH with adnexal preservation with~     TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical~     outcomes~   "
74184|NCT02086331|"~     This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the~     blood supply to the muscles of the leg, and how this changes with exercise and vascular~     pathology.~   "
74185|NCT02086318|"~     To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population~     of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age~     and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term~     of both reproductive prognosis and distance to menopause following the guidelines of the~     Standards for Reporting of Diagnostic Accuracy initiative (STARD)~   "
74186|NCT02086305|"~     Palliative care for end-stage organ failure patients has been included as one of the key~     programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the~     disease groups, end-stage heart failure patients have the highest mortality rate. Patients~     at the end stage of heart failure have health concerns shared by other end-stage patients~     including cancer patients. Many guidelines, local and world-wide, have advocated a~     palliative approach of care for those heart failure patients who are at end stage. Studies~     have shown that end-stage heart failure patients tend to have frequent emergency room visits~     and repeated hospital admissions. Also, these patients suffer from a number of health~     problems that adversely affect their Quality Of Life.~      There is scarcity of experimental studies informing practitioners which models work best for~     palliative patients in Hong Kong. There were randomized controlled trials conducted outside~     Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce~     readmissions but evidence is not present for other outcomes such as symptom control and~     carer burden.~      In an attempt to fill knowledge gap and inform practice using evidence, this study is~     launched to compare the effects of a customary hospital-based palliative heart failure care~     and an interventional Home-based Palliative heart failure Program.~      Hypothesis~        -  there is no difference in health care utilization for end-stage heart failure patients~          between the customary hospital-based group and the Home based palliative heart failure~          program group~        -  there is no difference in evaluated health outcomes (functional status, symptom~          intensity, and satisfaction with care) between the customary hospital-based group and~          the Home based palliative heart failure program group~        -  there is no difference in perceived health outcomes (quality of life, caregiver burden)~          between the customary hospital-based group and the Home based palliative heart failure~          program group~        -  there is no difference in cost effectiveness between the customary hospital-based group~          and the Home based palliative heart failure program group~        -  there is no difference In patients' lived experiences between the customary~          hospital-based group and the Home based palliative heart failure program group~   "
74187|NCT02086292|"~     The aim of the study is to find a simple method for pain reduction that can be used in~     clinical practice when administering digital nerve block with a single subcutaneous~     injection. It will be investigated whether a smaller volume of lidocaine can decrease pain~     during injection.~   "
74188|NCT02086279|"~     To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to~     assess whether this variation correlates with changes in the antral and pre-antral follicle~     ultrasonographic count (AFC).~   "
74189|NCT02086266|"~     The purpose of this study is to compare the efficacy between a Pilates exercise program and~     a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation~     (AES) in the recovery of urinary continence (UI) after radical prostatectomy.~      There are no studies that evaluate Pilates mat exercises for incontinence in men although it~     can be assured that this method has the pelvic floor contractions as a principle for~     practice. If this new therapeutic approach proves to be as effective as described treatment~     in improving urinary complaints, it will be an option for patients who prefer a non-invasive~     treatment.~   "
74207|NCT02086032|"~     Investigators have found that sleeping disorder is an important problem in menopausal women.~      There have been papers reporting the effect of hormonal therapy on sleeping, but fews have~     reported the effect of different progestogens on sleeping quality. There is a need for more~     in-depth study and more conclusive evidence about the progestins which have the most~     beneficial effects on sleeping disorders in menopausal women.~      This study is going to collect the data from newly identified menopausal patients who are~     eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The~     affects of the therapy will be monitored for 3 months.~   "
74208|NCT02086019|"~     For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an~     invasive-guided strategy will prove superior to a conservative strategy with respect to a~     combined endpoint of all cause mortality and non-fatal myocardial infarction.~   "
74190|NCT02086253|"~     Endothelial dysfunction of conduit arteries contributes to the increased morbidity and~     cardiovascular mortality in patients with essential hypertension and appears increasingly as~     an independent therapeutic target. We have shown previously that besides a decrease in the~     availability of NO and other endothelium-derived vasodilators factors, the~     epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a~     role in the pathophysiology of this endothelial dysfunction. Indeed, the local~     concentrations of endothelin-1 during the endothelium-dependent dilation of the radial~     artery in response to a sustained increase in blood flow decreased significantly in healthy~     volunteers controls but not in hypertensive patients. This lack of adaptation of the~     endothelinergic system could be due to a decreased clearance of endothelin-1 by endothelial~     ETB receptors, potentiating the vasoconstrictor action of endothelin-1 mediated by ETA~     receptor activation at the muscular level. However, to validate this hypothesis , it is~     needed to demonstrate the physiological role of ETA receptor and ETB in sustained~     flow-mediated dilatation of conduit arteries.~   "
74191|NCT02086240|"~     The Translocator Protein (TSPO) is a protein which reaches very high levels when there is~     inflammation in the brain.~      Recently, radioligands have been developed which attach to the TSPO (a radioligand is a drug~     which has been tagged with radioactivity). Using positron emission tomography (PET) imaging,~     the radioligand can be detected following injection into a patient. However, it is difficult~     to accurately measure the amount of TSPO using PET at the moment. This is because the brain~     does not have a reference region for TSPO (ie an area in the brain with no TSPO at all).~     Reference regions are very useful to help work out how much of a PET signal represents~     specific binding (of the radioligand to the target of interest), and how much represents~     non specific binding (of the radioligand to many other structures which are not of~     interest). In the absence of a reference region, non specific binding can be estimated by~     giving a drug which binds to the TSPO.~      The drug prevents the radioligand binding the TSPO and (in a manner of speaking) creates a~     temporary reference region so non specific binding can be measured. To do this, we will use~     XBD173 (Emapunil is an anxiolytic drug which acts as a selective agonist at the peripheral~     benzodiazepine receptor) to bind TSPO and block binding of the PET ligand ([11C]PBR28), a~     TSPO ligand from the phenoxyarlyacetamide class.~      Most TSPO PET studies (and in one of our previous studies approved by West London REC)~     quantify the signal using a ratio of specific binding in the brain to radioactivity in the~     blood. This requires arterial line insertion which is burdensome for subjects, and increases~     variability. In this study we aim to determine the ratio of specific binding in the brain to~     nonspecific binding in the brain by using the temporary reference region. For more accuracy~     the participants will repeat the scanning procedure so determine test-retest variability of~     the amount of TSPO.~   "
74192|NCT02086227|"~     The primary objective of this study is to ascertain the pharmacokinetics (PK) and~     pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of~     Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford~     Laboratories), 1 mg (1 IU), SC in healthy adult subjects.~   "
74193|NCT02086214|"~     The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive~     pressure therapy on Assisting Hand Assessment (AHA) performance in Cerebral Palsy (CP). To~     perform this study, 80 CP patients aged of 5 to 10 years old will be included in a~     multicentric, double blind, prospective parallel-group randomized study. Treatment will be a~     pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary~     outcome is to increase of 60% of AHA performance. The secondary outcome are to increase~     Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory~     Evoked Potentials (SEP).~   "
74194|NCT02086201|"~     This is a non-inferiority trial of Engage, a new intervention for late-life depression, and~     problem solving therapy (PST). Patient participants will be randomized to either Engage or~     PST and receive 9 weeks of either intervention. Interview assessments will be collected at~     baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from~     mental health agencies, will be randomized to receive training and certification in either~     Engage or PST.~   "
74195|NCT02086188|"~     The purpose of this study is to determine if treatment with Mirabegron will improve urinary~     urgency control beyond that achieved with pelvic floor exercises alone~   "
74196|NCT02086175|"~     This research study is evaluating a drug combination called Imprime PGG and Rituximab as a~     possible treatment for relapsed/refractory indolent B cell non-Hodgkin lymphomas (NHL).~   "
74197|NCT02086162|"~     Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is~     four times the rate in the general population. Cessation treatments are effective, but these~     smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to~     engage this group of smokers into effective treatments, we developed a single-session,~     web-based, motivational decision support system, Let's Talk About Smoking. The system~     incorporates features that insure high usability among those who can't use current websites~     due to cognitive impairments and low computer skills. It provides compelling content that~     engages users into evidence-based cessation treatments.~      In this study we will definitively test the decision support system in a randomized~     controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders.~     Our proposed study design will enable us to test whether this system, designed for those~     with cognitive impairments, is effective among people with a range of cognitive abilities.~     The Specific Aims of the study are:~        1. To determine whether use of the web-based decision support system leads to higher rates~          of initiation of smoking cessation treatment than use of a computerized educational~          pamphlet. We will also assess effectiveness on secondary outcomes, including smoking~          behavior, urges and outcome expectancies; level of dependence; intentions to quit and~          to use cessation treatment; and abstinence.~        2. To assess whether cognitive ability moderates initiation of smoking cessation~          treatment. Since cognitive impairment impedes use of standard web-based interventions~          by this group, and cognitive impairments likely supersede other potential moderators~          (education and socioeconomic status), this aim will be key to determining the success~          of our intervention and will guide further revisions if they are needed.~        3. To explore the effects of the decision support system and baseline cognitive ability on~          abstinence over 6 months~             1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence~               at 6 months, and cumulative days of tobacco abstinence over 6 months.~             2. We will determine whether baseline cognition (scale scores) is associated with~               7-day point prevalence tobacco abstinence at 6 months, and cumulative days of~               tobacco abstinence over 6 months.~   "
74198|NCT02086149|"~     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise~     intervention for helping individuals with elevated depressive symptoms to quit smoking. The~     investigators expect that this project will contribute much needed knowledge about the role~     that aerobic exercise can play in smoking cessation. The long-term goal of this program of~     research is to disseminate an effective, aerobic exercise (AE) intervention for smoking~     cessation that can be readily adopted by smokers with elevated depressive symptoms,~     including those with current major depressive disorder (MDD).~   "
74209|NCT02086006|"~     This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with~     single de novo, Type A lesions < 10 mm in length and located in a native coronary artery~     with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and~     IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg~     of Myolimus.~        -  Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at~          baseline and at 6 months.~        -  Optical Coherence Tomography (OCT) will will be completed for all patients at baseline~          and at 6 months.~        -  Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12~          and 24 months.~   "
74199|NCT02086136|"~     Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an~     array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score as a~     bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several~     studies as a biomarker of AD, and has showed a pooled diagnostic sensitivity of 97%.~     However, considering the severe morbidity and mortality of AD, a negative D-dimer per se is~     considered insufficient to rule-out AD in unselected patients.~      The aim of the present study is to evaluate whether the diagnostic performance of D-dimer~     differs in patients at different clinical risk of AD, and in particular whether a negative~     D-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to~     perform urgent aortic imaging.~      Consecutive adult patients with suspected AD presenting to ED will be enrolled before the~     establishment of a final diagnosis; a standardized clinical form comprehensive of~     presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels~     measured at presentation.~      The aortic imaging exam used to confirm or refuse of AD will be computed tomography~     angiography or transesophageal echocardiography and final diagnosis established after~     reviewing of all available data.~      The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized~     clinical stratification via the ADD risk score with D-dimer testing will therefore be~     assessed.~   "
74200|NCT02086123|"~     Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various~     pathology from diverticular disease to colon cancer. In comparison to conventional open~     surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower~     wound-related complication rates, better cosmetic results and earlier return to normal~     activities.~      Despite the fact that laparoscopic colorectal surgery is done through smaller incisions,~     there is still a considerable amount of abdominal wall trauma with these procedures. This~     still can cause a significant amount of postoperative discomfort, which can add to patients'~     stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can~     be difficult to control and has been mainly managed pharmacologically with the use of~     narcotics and non-narcotic medications delivered through different routes. The effectiveness~     of pain control depends on the medication, its dosage, frequency and route of~     administration. The latter is mainly achieved through the intravenous route in the immediate~     postoperative period in laparoscopic colorectal surgery patient, as patients are restricted~     from having anything by mouth until return of bowel function.~      Another route of delivery is the use of local anesthetics as well as opioids via an epidural~     catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and~     decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia~     in obstetrics, to date there has been very few studies looking at the effectiveness of~     epidural analgesia in laparoscopic colorectal surgery.~      The primary purpose of this study is to evaluate the impact of epidural analgesia as~     compared to conventional analgesia on the length of hospital stay in patients undergoing~     laparoscopic colorectal procedures. The secondary objectives of the study will be to~     evaluate patient satisfaction, quality of life, pain control and return of bowel function in~     patients treated with either epidural analgesia or intravenous narcotics.~   "
74201|NCT02086110|"~     The purpose of this study is to determine the tolerability of dietary supplements and if~     these supplements can promote a healthy bacterial environment in the intestines of children~     with autism spectrum disorders and gastrointestinal complaints.~   "
74202|NCT02086097|"~     The purpose of this study is to investigate the analgesic efficacy of multiple doses of~     Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic~     treatment in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a~     placebo group.~      Hypothesis:~      Dexketoprofen trometamol when administered in multiple doses produces a greater effect to~     control postoperative pain after treating symptomatic irreversible pulpitis; in patients~     undergoing pulpotomy as an emergency procedure~   "
74203|NCT02086084|"~     Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases~     and is responsible for a significant number of acute hospital admissions. COPD is~     characterised by progressive destruction in the elastic tissue within the lung, causing~     respiratory failure. The clinical course of COPD is characterised by recurrent acute~     exacerbations (AECOPD), causing considerable morbidity and mortality. Patients with moderate~     to severe acute exacerbations present with increased work of breathing and hypercapnia. The~     standard for respiratory support in this setting is non-invasive ventilation (NIV), a~     management strategy underpinned by a considerable evidence base. However despite NIV, up to~     30% of patients with AECOPD will 'fail' and require intubation and mechanical ventilation.~     The mortality rate for patients requiring NIV is approximately 4%, if conversion to~     mechanical ventilation occurs the mortality is 29%.~      The last decade has seen an increasing interest in the provision of extracorporeal support~     for respiratory failure. The key element that has underpinned improving survival has been~     technological advancement. This has resulted in pumps causing less blood trauma and~     inflammatory response, better percutaneous cannulation techniques and coated circuits with~     reduced heparin requirements. Overall this has significantly reduced the complications~     associated with the provision of extracorporeal support. One variation of this technique~     (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has~     been the subject of a number of animal experiments and uncontrolled human case series~     demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished~     series demonstrates the same physiological changes. However to date the benefits of this~     approach have not been tested in a randomised controlled trial.~      The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and~     reduce likelihood of intubation.~   "
74204|NCT02086071|"~     Feasibility of new biological and histological samples at progression in patients with~     advanced or metastatic Non Small Cell Lung Cancer (NSCLC).~      A recent paper from Pr Sequist and coll. has depicted the resistance mechanisms as~     Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies~     showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3~     patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine~     Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of~     the disease. This study will be conducted by the Groupe Français de Pneumo Cancérologie~     (GFPC) up to 100 patients during 18 Months. Each center will have to define if re-biopsies~     are possible or not and explain why not.~   "
74205|NCT02086058|"~     The aim of this study (the hypothesis) is to identify differences in the gene expression~     profile in the bladder muscle and hereby gain greater knowledge about the muscular~     mechanisms that cause overactive bladder and daytime urinary incontinence in children older~     than 5 years. A secondary aim is to examine how this gene expression profile differs from~     children with a neurogenic overactive bladder and how the gene expression profile changes~     from childhood till adulthood. Such new knowledge will result in a more precisely targeted~     and hence effective treatment of overactive bladder.~      The results will be obtained by retrieving bladder biopsies from children and adults~     suffering from an overactive bladder or a neurogenic bladder. These biopsies will undergo~     molecular analysis and the investigators will compare them with biopises from bladder~     healthy adults and children.~   "
74206|NCT02086045|"~     To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting~     Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native~     coronary artery lesion designated the target lesion and up to one non-target lesion located~     in a separate epicardial vessel.~   "
87747|NCT01908803|"~     The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic~     Suspension relative to ototopical CIPRODEX for microbiological success at Day 8 and time to~     cessation of otorrhea.~   "
74210|NCT02085993|"~     Cross-sectional study, observation made by healthcare professionals of subjects or~     caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after~     training with the home administration training pack. Further observations can also be~     recorded in the study if made within 16 weeks of enrolment. Data will be collected from the~     subjects' dose diary at their first standard of care visit to ensure there were no problems~     with administration while not at the clinic.~   "
74211|NCT02085980|"~     The purpose of this study is to assess the safety and the efficacy of a laser in the~     treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the~     vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).~   "
74212|NCT02085967|"~     This study will be a single center, open-label, drug-drug interaction study in healthy male~     and female subjects. The study will consist of 2 parts. In Part A, the effects of~     steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the~     pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will~     be sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in~     equal numbers (approximately 15 subjects per group). The itraconazole treatment group will~     be fully enrolled before enrollment is initiated for the rifampin treatment group. In Part~     B, the effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a~     substrate of CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately~     24 subjects. The 2 study parts can be conducted in parallel.~   "
74213|NCT02085954|"~     Stroke patients in the investigators rehabilitation unit follow gait trainings with~     robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed~     with 3D gait analysis. The objective of this study is to assess the effects of gait training~     in Lokomat on biomecanic gait parameters in stroke patients.~   "
74214|NCT02085941|"~     This research study is evaluating a procedure called cryoablation (the removal of diseased~     tissue using extreme freezing temperatures) as a possible treatment for head, neck and spine~     tumors.~   "
74215|NCT02085928|"~     Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue~     percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which~     consists in the application of a galvanic current through a puncture needle which produces a~     local inflammatory process in the soft tissue and the reparation of the affected tissue.~      The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of~     a multimodal program using the intratissue percutaneous electrolysis technique and exercises~     in the short term for patients with chronic lateral epicondylitis, and to determine whether~     the clinical outcomes achieved decline over time.~      This study is an observational one-way repeated measures design. 36 patients in a clinical~     setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6~     months) received one session of EPI per week over 4-6 weeks, associated with a home program~     of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS,~     digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural~     tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of~     overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included~     recurrence rates (increase of severity of pain or disability compared to discharge), the~     perception of overall outcome and success rates. Paired Student t-tests and Chi squared~     tests were applied to data. Enrollment into this study ended in September 2012.~      All outcome measures registered significant improvements between pre-intervention and~     discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks.~     The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of~     the extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all~     participants (32) perceived a 'successful' outcome. Recurrence rates were null after~     discharge, and at the 6, 26 and 52 week follow-ups.~   "
74216|NCT02085915|"~     The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic~     patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an~     essential stake to improve the forecast.~      Investigators would so like to estimate the interest of the strip PeriScreen for the fast~     diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients,~     what would allow to make out a will at least on ascites 2000 on about twenty centers for~     duration estimated of 12 months.~   "
74217|NCT02085902|"~     Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy~     can be performed as outpatient surgery. This approach is difficult in many centers because~     of post operative pain and nausea/vomiting.~      The use of postoperative morphine may be responsible for the state of nausea. The use of~     ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to~     have their surgery as an outpatient.~      Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it~     was used for the infiltration holes trocar. In recent years, ropivacaine is used for the~     reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery (~     hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to~     view the many publications made on this subject. Its use in the investigators daily surgery,~     however, has not been evaluated in ambulatory surgery.~   "
74218|NCT02085889|"~     Background: The association of fructose and lactose intolerance and malabsorption with the~     symptoms of different functional gastrointestinal disorders (FGID) is unclear. The~     mechanisms behind the multi-organ symptoms remain unclear. Both FGID and saccharide~     intolerances are common (>10% of any given population). Dietary modification based on~     intolerance diagnostics could provide an effective treatment for FGID, which are otherwise~     difficult to treat.~      Aim: To investigate the prevalence and interrelationships of fructose and lactose~     intolerance (symptom induction) and malabsorption (breath test gas production) and their~     association with clinical GI as well as non-GI symptoms in FGID and the outcome of standard~     dietary intervention. Mechanisms related to symptom genesis will be investigated using~     metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass~     spectrometry (GC/TOFMS).~      Methods: Fructose and lactose intolerance (defined by positive symptom index) and~     malabsorption (defined by increased hydrogen/methane) will be determined in successive male~     and female FGID patients in a single center using breath-testing. Symptoms will be recorded~     using standardised questionnaires and the Rome III criteria. The prevalence of the~     intolerances in the different FGID subgroups and the associations between breath testing~     results, clinical symptoms and the outcome of dietary modification will be assessed. Factors~     predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used~     to assess the human and microbial metabolome in urine and plasma.~   "
74395|NCT02083562|"~     The purpose of this study is to assess the association of biomarkers on day 7 of life with~     the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short~     lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate~     whether certain capnographic indices are able to reflect the degree of lung disease.~   "
74219|NCT02085876|"~     This is a single centre prospective open-label, non-randomised pilot study whose aim is to~     identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the~     near future, to avoid the need for liver biopsy.~      To achieve this:~        -  The MRI study will be completed by adding two sequences: Measurement of T1 and~          multiecho T2*. The other data will be extracted from usual sequences.~        -  Part of the histological samples will be used for the weighted levels of fat and iron,~          and for the lipidomic study.~        -  Usual blood samples will be completed by samples for the serum library~   "
74220|NCT02085863|"~     This is a single center, randomized, double blind, placebo controlled, 2-way crossover~     drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of~     ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive~     combination.~   "
74221|NCT02085850|"~     Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be~     non-glaucomatous in the Tema Eye Survey.~      Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed~     with glaucoma in the Tema Eye Survey.~   "
74222|NCT02085837|"~     Improve health and outcome for people with late stage chronic kidney disease by providing~     patient centered nursing services in addition to a Nephrologist's routine patient care.~   "
74223|NCT02085824|"~     The purpose of this study is to determine which of the following drugs: enoxaparin,~     dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).~   "
74224|NCT02085811|"~     The aim of this retrospective study is to show that kyphoplasty is a reliable technique in~     the treatment of certain traumatic vertebral fractures.~      Patients will be selected from medical records archived at the Neuroradiology Department of~     Dijon CHU.~      An information sheet and questionnaire will be sent to patients together with a letter to~     ask them to have a radiographic examination.~      The radiographic images will be interpreted by two independent experts to evaluate the angle~     pf vertebral kyphosis.~   "
74225|NCT02085798|"~     Post-authorisation observational study to assess the evolution in normal clinical practice~     of patients recently diagnosed with myelodysplastic syndrome (MDS) or chronic myelomonocytic~     leukaemia (CMML), depending on the moment when active treatment is initiated. Subjects will~     be recruited from approximately 50 haematology sites in Spain.~   "
74226|NCT02085785|"~     The purpose of this study is to pilot test a program to help overweight and obese~     individuals with a lower extremity amputation (LEA) lose weight and become more physically~     active. The investigators will randomize approximately 30 individuals to either a~     self-directed weight loss program (n=15) or a coached weight loss program (n=15). The~     primary purpose of this pilot study is to determine if a home-based weight loss/physical~     activity (PA) intervention is feasible in individuals with a LEA. MOVE-LEAP is a 20-week~     program that involves 11 phone calls from a health coach and a single home visit by a~     physical therapist.~      This pilot study aims to:~        1. test the feasibility of recruiting overweight/obese individuals with LEA into a~          randomized trial;~        2. assess whether the intervention can be delivered with high fidelity, and~        3. evaluate whether the intervention is acceptable to and safe as determined by~          participant feedback, participation and retention for outcome measures.~   "
74227|NCT02085772|"~     This is a single-centre observational, prospective study carried out at the maternity unit~     of Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will~     evaluate in these patients, the activation and migration capacities of circulating~     leukocytes and their association with the onset of spontaneous labour.~      Patients who meet the inclusion criteria will be informed about the study during their~     consultation at the 7th or 8th month, and their gynecologist will invite them to take part.~     If the answer is positive, the patients will be seen again at a specific consultation for~     the study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU.~     During this consultation, the gynecologist will conduct a medical examination, while the~     Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes~     and 1 x 7ml tube).~      If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another~     consultation (consultation programmed in the usual follow-up of pregnancy) and a second~     blood sample (1 x 6ml tube and 1 x 7ml) will be taken.~      The patients will be followed until childbirth and will be split into two groups according~     to whether or not they gave birth after the onset of spontaneous labour.~   "
74228|NCT02085759|"~     Cytokines are chemicals that are naturally made by your body. Certain cytokine levels are~     changed in the blood of patients who develop allergies and/or asthma. Cytokine levels may~     also be changed in some individuals who are overweight or obese. The purpose of this study~     is to determine if certain cytokine levels differ based on a person's weight and whether or~     not they have allergies or asthma. Information gathered in this study will be compared to~     information gathered from subjects who have participated in another similar study for~     patients who have allergies and/or asthma.~   "
74229|NCT02085746|"~     This will be a descriptive study using patients from the Urogynecology and Urology~     University of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark~     on 30th Street to analyze the impact of demographics on the definition of being sexually~     active. It is believed one's demographics influence their definition of being sexually~     active.~   "
74239|NCT02085616|"~     The purpose of this study was to compare the effectiveness of the high-intensity proactive~     service with the low-intensity reactive service at the Swedish National Tobacco Quitline~     (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in~     reactive service.~      The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive~     behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to~     offer the client a choice of callback (proactive service) or no callback (reactive service).~     In the present study clients were not offered a choice, but were randomized to proactive~     service on even dates and to reactive service on odd dates. Data are collected through~     postal questionnaires, one baseline and one follow-up after 12 months.~   "
74240|NCT02085603|"~     This study is designed to assess whether a drug called Saracatinib is helpful in controlling~     bone pain from cancer. The investigators do not know if it will be, so half of the patients~     in the study will receive the drug and half will get placebo. Saracatinib is a drug that has~     been tried in patients with many different forms of cancer. It seems to have effects in bone~     and so the investigators hope that it will have an effect in those with cancer that has~     spread to the bones.~   "
74230|NCT02085733|"~     Background:~      Children presenting with non-traumatic joint pain require different treatment depending on~     the cause of pain. Septic arthritis, which results from a bacterial infection in the joint,~     often requires a surgical procedure as well as a long course of antibiotics. In contrast,~     non-septic arthritis is typically treated by management of symptoms and observation. Current~     diagnostic standards involve microbiologic examination of fluid taken from the affected~     joint. This procedure can require the patient to be sedated, and the fluid culture analysis~     can take up to 72 hours. A single laboratory measure that could be easily obtained and~     quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the~     diagnostic work-up for this condition.~      Recent research on septic arthritis has identified procalcitonin as a potential septic~     arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at~     higher levels when the body is facing infection. Procalcitonin levels rise slowly over the~     first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream~     during this time frame. Several studies have indicated PCT is promising potential diagnostic~     indicator for septic arthritis. Unfortunately, many of these studies have relatively small~     sample sizes and very few involve pediatric populations. Additional study of PCT and septic~     arthritis in children will help evaluate the viability of PCT as a diagnostic indicator.~      Research Question:~      Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and~     non-bacterial arthritis?~      Methods:~      Patients presenting with possible septic arthritis in the emergency department will be~     recruited for this study. Patients who consent to participate will receive the current~     standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation~     rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and~     consultation with pediatric orthopedics. Patients participating in the study will have a~     portion of the serum collected for typical diagnostic tests analyzed for PCT. Research~     assistants will collect data from medical records of participants, including lab and imaging~     results. Patients who do not undergo surgery will be contacted by phone within 7 days of~     their ED visit to confirm diagnosis.~   "
74231|NCT02085720|"~     Objective: Obstructive sleep apnoea syndrome (OSAS) is a common form of sleep-disordered~     breathing (SDB) causing sleep fragmentation, daytime sleepiness, cognitive function~     impairment, and poor health status in addition to increased risk of cardiovascular~     complications. OSAS is equally common among the middle-aged male Caucasian and Hong Kong~     (HK) Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS~     in the elderly population in Asia including HK is unknown.~      Study Design: A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs~     in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness,~     restless leg syndrome, and sleep-related habits and routines, in addition to past medical~     history and medications. Home sleep study (EMBLETTA) capable of recording sleep (a single~     EEG channel), respiratory events, snoring, respiratory efforts and oximetry will be~     performed on 300 subjects randomly. Those who have negative or technical inadequate EMBLETTA~     study with a high pre-test probability of moderate to severe OSA will be invited to undergo~     hospital-based polysomnography for confirmation of their sleep apnoea status. Subjects with~     AHI>15/hr regardless of symptoms or those with AHI 5-15/hr plus comorbid conditions or~     excessive daytime sleepiness will be offered continuous positive airway pressure (CPAP)~     titration followed by CPAP treatment, with serial assessment of subjective sleepiness,~     quality of life, and cognitive function.~      Outcome measures: the prevalence rates of SDB (AHI>10, >15 and >30/hr), OSAS, and other~     sleep disturbances, such as restless leg syndrome (RLS). In addition, we will examine the~     factors which are predictive of the presence of SDB in this population, and assess the CPAP~     acceptance, compliance, and treatment outcome of those with OSAS.~   "
74232|NCT02085707|"~     Patients younger than 70 years with a displaced femoral neck are in serious conditions. The~     femoral neck fracture is associated with low activity levels, hip pain and substantially~     reduced quality of life. Relatively young individuals with low-energy fractures tend to have~     additional morbidity or lower bone quality. The literature indicates that 5 % of all~     displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and~     lack of consensus and guidance about appropriate treatment of these patients renders choice~     of treatment, and the health economic aspect a great challenge. In this study the~     investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy~     femoral neck fractures treated with a total hip arthroplasty leads to a better functional~     outcome than osteosynthesis, and can patient-related factors be identified that predispose~     for femoral fracture? It is a randomized multi center study of patients operated with either~     total hip arthroplasty or osteosynthesis in which functional outcome, complications and~     reoperations are compared for the 2 groups. Additional controls are done after 4 and 12~     months; 2 and possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that~     predispose for displaced femoral neck fractures for patients aged 55 - 70 years. Map bone~     density measured with Dexa for two types of surgical procedures. Map complications and~     functional outcome after osteosynthesis or total hip replacement in patients aged 55 - 70~     years with displaced femoral neck fractures.~   "
74233|NCT02085694|"~     A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by~     high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test~     whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and~     severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing~     HSCT.~      Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM~     in the patients undergoing HSCT.~   "
74234|NCT02085681|"~     The aim of this study is to compare the effectiveness of identifying diabetic retinopathy~     using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the~     conventional referral system.~      Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will~     identify proportionately more diabetic patients with DR and lead to higher acceptance rate~     with subsequent ophthalmic referral and management~   "
74235|NCT02085668|"~     The purpose of the trial is to investigate the safety and effectiveness of renal denervation~     for the treatment of chronic heart failure (CHF).~   "
74236|NCT02085655|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's~     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the~     efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with~     gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.~   "
74237|NCT02085642|"~     The purpose of this study is to investigate if acupuncture is more effective than sham~     treatment in reducing lower extremity spasticity, and improving gait speed in the chronic~     phase of stroke recovery.~   "
74238|NCT02085629|"~     To collect evidence of the safety of administering donor-derived regulatory macrophage (M~     reg) preparations to living-donor renal transplant recipients in the context of an~     international European Union funded consortium aimed at evaluating cellular immunotherapy in~     solid organ transplantation (The ONE Study). It is anticipated that immune regulation~     induced by M reg therapy can eventually be used to reduce the need for conventional~     immunosuppression in transplant recipients.~   "
74241|NCT02085590|"~     In the present study, we want to investigate whether BCG-vaccination enhances the innate~     immune response in humans in vivo during (single) human endotoxemia.~      In a future experiment we will investigate whether BCG-vaccination can reverse the tolerant~     state observed upon a second LPS administration.~      Our goal is to ultimately translate our results into clinic applications to reverse for~     example sepsis-induced immunoparalysis.~   "
74242|NCT02085577|"~     Patients with a daily use of opioids may develop higher postoperative pain levels, often~     need high doses of morphine and therefore their pain may be difficult to treat. A low dose~     of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain~     and morphine consumption in these patients. Our purpose is to investigate the effect of low~     dose ketamine on morphine consumption and pain after spine surgery in patients with a daily~     use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption,~     pain and side-effects after spine surgery.~   "
74243|NCT02085564|"~     Background:~      The prevalence of gastroesophageal-junction cancer (cancer between the distal part of the~     oesophagus, and proximal part of the stomach/GEJ-cancer) is increasing in Denmark with more~     than 400 patients per year. The 5-year overall survival is less than 10% for the 2/3 of the~     patients, which are not considered resectable. Even for the 1/3, which is treated with~     surgical intervention and neoadjuvant chemotherapy the overall-survival is approximately~     30%.~      The current Danish intended curative treatment consists of esophagectomy (surgical resection~     of the oesophagus with extended lymphadenectomy in abdomen and thorax (removal of~     lymphnodes)). Furthermore, perioperative chemotherapy consists of 6 series neoadjuvant~     chemotherapy (3 series before, and 3 series after operation).~      Unresectable patients receive palliative chemotherapy and no resection. Peritoneal washing~     cytology (PWC) is a recommended prediagnostic modality in gastric cancer patients. The~     method is used to detect free peritoneal cancer cells in the abdominal cavity even when~     macroscopic carcinomatosis is not present (i.e. the cancer has spread to other parts of the~     abdomen).~      Carcinomatosis can be found in up to 19% in gastric cancer patients often in the peritoneum.~     Positive peritoneal cytology (C1) can be identified in up to 7% of gastric cancer patients~     without metastases (C1M0), i.e. malignant cells can be identified in the peritoneal washing,~     but tumor spread has not been identified.~      Lots of studies indicate that C1-disease is an independent prognostic predictor for~     decreased survival, and increased recurrence rate, comparable with M1 patients (i.e.~     patients with distant metastases).~      The American Joint Committee on cancer recommends that C1 patients should be treated~     non-surgically - even when M1 disease has not been identified.~      On the basis of the above, PWC can be used to identify patients at greater risk for~     recurrence, and thereby not candidates for intended curative treatment.~      It is a fact, though, that C1M0 patients have a better survival than C1M1 patients.~     Currently, there is no level-1 evidence for specific treatment of C1M0 patients, why further~     research is required to approach this patient group in the most comprehensive way. The focus~     group of our study is therefore C1M0 patients, because of the difference in opinions.~     Furthermore most evidence is based on gastric carcinomas, why GEJ-cancer patients are the~     group, we will examine.~      Purpose:~      Peritoneal washing cytology (PWC) is performed as a standard prediagnostic modality at~     Rigshospitalet, for patients with gastric- and GEJ cancer, considered resectable at~     preceding multidisciplinary conference. Most studies in the past 20-years have focused on~     gastric cancer, and not specifically GEJ-cancer.~      This study will determine the usefulness of peritoneal washing cytology, and thereby~     verifying our own standard regarding GEJ-cancer. Furthermore, we will determine the effect~     of neoadjuvant chemotherapy on free peritoneal tumor cells and its correlation with overall~     survival.~      This study is intended as a validation of our own standard.~   "
74244|NCT02085551|"~     The primary objective of this retrospective case review study is to determine the safety and~     effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of~     patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a~     retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will~     be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as~     measured by TIMI scores and procedural serious adverse events are assessed and recorded.~   "
74245|NCT02085538|"~     Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not~     expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA)~     Guidance recommends a study in subjects with renal impairment when the drug is likely to be~     used in patients with impaired renal function. Palbociclib is intended for chronic use in~     cancer patients who may have some degree of impaired renal function.~   "
74246|NCT02085525|"~     A retrospective chart review of patients receiving concurrent chemoradiotherapy for~     oropharynx cancer was performed to compare clinical data for patients treated prior to the~     initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The~     variables studied included; rate of hospitalization, dose completion and dose reductions.~     The results revealed an overall improvement in all variables for those patients seen in the~     weekly NP clinic.~      To further analyze this data a randomized, prospective study is proposed to validate the~     findings of the retrospective study. It is predicted that a weekly NP led clinic will~     decrease costly hospitalizations, increase patient treatment completion and improve overall~     patient quality of life and satisfaction.~   "
74247|NCT02085512|"~     The proposed work will evaluate the ability of neurocognitive retraining of executive~     functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma~     exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis~     that impaired emotional regulation interferes with the expected recovery from the early~     responses to traumatic events, leading into a chronic disorder. In an initial phase the~     investigators will recruit 20 recently traumatized participants among trauma survivors~     admitted to a general hospital emergency room and test the planned intervention's acceptance~     and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors~     into a randomized controlled study of the new intervention. The intervention will consist of~     web-based neurobehavioral training interventions that instill an emotional bias toward~     positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional~     distraction, and enhance executive functioning. Control participants will complete web-based~     video games that do not have emotion-regulatory benefits. Outcome measures will include~     improvement in neurocognitive functioning and in PTSD symptoms.~   "
74248|NCT02085499|"~     The use of non-invasive methods of respiratory support to reduce complications of prolonged~     invasive mechanical ventilation in preterm infants has increased.~      The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the~     interval between mechanical breaths is fixed and is determined by the frequency dialed by~     the clinician. Asynchrony between the infant's spontaneous breathing may exist since~     mechanical breaths delivered at fixed intervals can occur at different times over the~     inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is~     a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the~     infant's spontaneous inspiration. This has been achieved by using techniques to detect the~     infant's spontaneous inspiration.~      The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to~     be determined.~      This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on~     ventilation and gas exchange in premature infants who require supplemental oxygen.~      The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation~     (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange~     and reduce breathing effort.~      The objective of the study is to compare the effect of flow synchronized-NIMV to~     non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing~     effort, apnea and chest wall distortion in preterm neonates with lung disease.~   "
74449|NCT02082834|"~     The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient~     with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based~     iterative reconstruction (MBIR- VEO TM).~   "
74450|NCT02082821|"~     Heart transplantation is a lifesaving procedure for patients with end-stage heart failure~     and provides a better survival and quality of life as compared to conventional medical or~     pharmacological treatment. Transplanted hearts are subject to the effects of the alloimmune~     response, which if left uncontrolled is capable of jeopardizing long-term cardiac function.~     Recently, advances in immunosuppression have enhanced the survival of transplanted patients.~     Nearly 2500 cardiac transplants per year have been performed in the US during the last 10~     years and despite significant improvements, long-term cardiac allograft survival rates~     remain poor. More than 20% of patients do not survive beyond 3 years, and those who do~     survive are afflicted with the long-term complications associated with chronic~     immunosuppression. Life expectancy of patients who lose cardiac allografts is dramatically~     poor due to the absence of any therapeutic tool apart from re-transplantation, which is~     plagued by poor outcomes. The identification of novel therapeutic targets is thus mandatory.~     ATP/P2X7R signaling in T cells is highly relevant for cardiac allograft survival. ATP is a~     small molecule present at high concentrations inside cells and released as extracellular ATP~     (eATP) following cell damage or death, which is abundant at inflammation sites and acts as a~     danger signal constituting an alerting system. ATP is sensed by the ionotropic purinergic~     P2X receptors (seven receptors named P2X1-7) expressed mainly, but not exclusively, by T~     lymphocytes, thereby regulating T cell activation. We have recently demonstrated that the~     ATP/P2X7R axis has a key role in cardiac allograft survival in humans and mice. Cardiac~     allograft vasculopathy (CAV) is a major limiting factor for cardiac allograft survival. One~     of the major limiting factors for cardiac transplantation is CAV, which develops frequently~     in heart transplant recipients. CAV results in allograft failure, and it occurs in 50% of~     cardiac transplant recipients by 5 years after transplantation, as shown by angiography or~     intravascular ultrasound examination. CAV is clearly of immunological origin, as syngeneic~     murine grafts do not develop CAV. Once CAV occurs, the most definitive treatment is~     re-transplantation, but survival is limited due to the fact that pharmacological management~     only somewhat attenuates the process. We hypothesize that a single nucleotide polymorphysm~     (SNP) loss-of-function P2X7R mutation (p.Glu496Ala / c.1513A>C, rs3751143) generates a~     compensatory upregulation of the other purinergic receptors (P2XsR), thus creating a state~     of hypersensitivity to eATP. This eATP hypersensitivity results in an abnormal generation of~     Th1/Th17 cells, that leads to CAV and early cardiac allograft loss. Our study will answer a~     fundamental question: What is the effect of the P2X7R loss-of-function mutation on the~     immune system? Our expertise in studying the ATP/P2X7R axis has been recently recognized in~     two publications and we are now ready to test our novel hypothesis on the P2X7R~     loss-of-function mutation. Our goal is to generate the first targeted-therapy for a selected~     group of cardiac transplant recipients.~   "
74249|NCT02085486|"~     The puncture of the vascular access in hemodialysis patients remains challenging even in the~     hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource~     wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor~     patient satisfaction.~      The use of ultrasound by emergency department nurses and technicians without prior~     ultrasound experience in patients with difficult intravenous access showed in several~     studies to be very efficient. The investigators expect to achieve similar results in~     cannulation of AV shunts by the dialysis nurse staff after a short learning program.~      To show this, the investigators aim to conduct a trail where standard cannulation technique~     (inspection, palpation) will be compared with the ultrasound-assisted method in terms of~     efficacy, safety and patient satisfaction.~   "
74250|NCT02085473|"~     The aim of this study is to evaluate the pharmacokinetics and tolerability of tralokinumab~     when delivered at different flow rates to healthy volunteers.~   "
74251|NCT02085460|"~     To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced~     oral mucositis in patients with head and neck cancer following administration of rebamipide~     and to determine the optimal dose of rebamipide.~   "
74252|NCT02085447|"~     This is a prospective study using a concierge model of customized adherence enhancement and~     long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or~     schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the~     CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most~     vulnerable of populations with schizophrenia but even more importantly, will demonstrate~     that it can be used to improve the efficiency and quality of care in typical practice~     settings.~   "
74253|NCT02085434|"~     The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric~     practices to manage the growing problem of pediatric overweight and obesity, starting with~     Stage 1, Prevention Plus, which encourages families to improve basic lifestyle choices~     related to eating and activity in order to improve BMI status. This study will test the~     effectiveness of an innovative FITLINE telephone counseling program for overweight and obese~     8-12 year olds seen in pediatric practices where nutritionists coach parents in improving~     their child's diet and physical activity, to reduce BMI. If found to be effective, the~     FITLINE program will provide a model for widespread implementation of Stage 1, Prevention~     Plus of the AAP expert committee recommendations through pediatric practices nationwide.~   "
74254|NCT02085421|"~     The proposed pilot study is a randomized controlled study to assess effectiveness of~     transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in~     patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active~     tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes)~     via two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The~     investigators hypothesis is that the use of tDCS will enhance the improvement seen with~     cognitive remediation therapy.~   "
74255|NCT02085408|"~     This randomized phase III trial studies clofarabine to see how well it works compared with~     daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in~     treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in~     chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells. It is not yet known which chemotherapy regimen is more effective in~     treating acute myeloid leukemia.~   "
74256|NCT02085395|"~     To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x~     height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's~     Disease) reduced at least 75%.~   "
74257|NCT02085382|"~     A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness~     in increasing the rate of weight gain among low birth weight neonates.~   "
74258|NCT02085369|"~     Following obesity surgery gastric bypass (GBP) patients usually lose more than 50% of their~     former obesity within a relatively short time (~ 2 years). But knowledge about the~     underlying psychological and biological mechanisms of decline in body weight, however, is~     still lacking. This project intends to investigate whether obesity surgery is associated~     with patients' cognitive ability and / or gene expression and metabolomics.~   "
74259|NCT02085356|"~     This study will test the effectiveness of a behavioral intervention to increase Prevention~     of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV~     positive pregnant women. This study will also determine whether the participation of male~     partners will have additional positive impact on PMTCT uptake. The intervention will utilize~     a combination of both gender-concordant groups and individual or couples counseling~     strategies, before and after birth. During antenatal care, the intervention will use a~     gender-concordant group format to address PMTCT information, HIV disclosure, coping with~     stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior~     to birth and following birth, the intervention will shift to individual or couples-based~     counseling, targeting medication adherence, safer infant feeding, and family planning. It is~     hypothesized that women attending the intervention will be more likely to properly take HIV~     medication before birth and provide it to their infants. Additionally, it is hypothesized~     that male partner involvement will further increase the likelihood that mothers will take~     their HIV medication as prescribed and provide it to their infants.~   "
74260|NCT02085343|"~     This study tests whether a single session of exposure therapy may be enhanced by the~     addition of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100~     acrophobic participants will be randomly assigned to receive standard exposure therapy~     (EXP), exposure therapy with safety behavior fading (EXP + SBF), exposure with safety~     behavior fading and anti-phobic actions (EXP + SBF + AA), or to a wait-list control group~     (WL).~   "
74327|NCT02084446|"~     This is a 12-month single center, randomized, open-label, single center study designed to~     compare the safety and efficacy of everolimus and very low dose tacrolimus versus~     enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant~     recipients.~      The purpose of this study is to compare safety and efficacy of two immunosuppressive~     regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated~     mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.~   "
74261|NCT02085330|"~     Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is~     about 15-20% of the population over the age of 65. The most common forms of dementia among~     the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular~     dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of~     coexisting of AD and VD among the dementia patients, defined as mixed dementia.~      Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also~     considered as a prodromal phase of both VD and AD. Its basic clinical features include:~     cognitive concern, reflecting a change in cognition, reported by the patient or informant~     (i.e., historical or observed evidence of decline over time), with objective evidence of~     impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as~     preservation of independence in functional abilities and not being demented (i.e., no~     significant impairment social or occupational functioning).~      Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases~     for more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen~     in plasma to a level sufficient to support tissues with minimal oxygen supply carried on by~     hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric~     oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it~     seems that HBOT might be an efficient and clinically feasible method capable of increasing~     tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically~     vascular-lesioned areas during the post microvascular lesion phase.~      This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT~     in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.~   "
74262|NCT02085317|"~     In this study the investigators have aimed to evaluate morphology and reactivity of~     cutaneous microcirculation in patients with lepromatous leprosy. Ten patients, without any~     other comorbidity were compared to ten controls without leprosy or any other comorbidity,~     using the Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of~     laser Doppler signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar~     diameter) and laser Doppler flowmetry associated to iontophoresis of vasoactive substances~     (acetylcholine and sodium nitroprusside).~   "
74263|NCT02085304|"~     A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to~     control. Recent studies show that survival improves for patients who get aggressive surgery~     to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment.~     Surgery, RT and chemo are part of regular cancer care for GBM. RT is usually done in daily~     doses 5 days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus~     some of the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also~     delivers radiation but in a larger dose over one day. GK sends beams to a precise target~     (tumor location) and very little normal brain tissue that is nearby. This study will compare~     GK treatment to the usual RT treatment after surgery, and with chemo.~      We want to know:~        -  How well each treatment keeps the tumor from growing back.~        -  What the effects (good and bad) of the treatments are.~        -  How you rate your quality of life.~        -  How the treatment affects your ability to think, understand, reason, and remember.~        -  How you rate your ability to think, understand, reason, and remember.~        -  If using a certain type of MRI scan can show the difference between new tumor growth~          and changes caused by treatment.~        -  If certain features found in tumor cells can help doctors predict how tumors will~          respond to treatment.~   "
74264|NCT02085291|"~     Increase in MAP from 65 mm Hg to patients' usual level by fluid improved sublingual~     microcirculation in early septic shock patients despite EGDT.~   "
74265|NCT02085278|"~     This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation~     (AVM). An AVM is an abnormal connection between the arteries and veins of the brain.~     Patients considered for this trial are 21 years and younger with AVM suitable for~     embolization treatment (a procedure used to block the abnormal connection between the~     arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill~     n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the~     embolization procedure to block the abnormal connection).~   "
74266|NCT02085265|"~     The purpose of this project is to conduct a proof of concept study in patients with probable~     Alzheimer's Disease who have mild to moderate hypertension, in order to determine if there~     is less global brain atrophy over one year, as measured by ventricular enlargement as a~     primary outcome measure, when patients are randomized to treatment with an angiotensin~     receptor blocker compared to an Angiotensin Converting Enzyme inhibitor (ACEI).~   "
74267|NCT02085252|"~     The purpose of this study is to assess two treatment strategies (leuprorelin treatment and~     active surveillance without androgen deprivation) for indolent prostate cancer and to~     compare their therapeutic benefit for management of patients with low-risk, localized~     prostate cancer.~   "
74268|NCT02085239|"~     This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in~     providing an extended period of pain relief for patients undergoing ultrasound guided core~     biopsy of the breast.~   "
74269|NCT02085226|"~     Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following~     stroke improve psychosocial outcomes? A feasibility trial of a creative engagement~     intervention for inpatient rehabilitation.~      This is a feasibility randomised controlled trial of a novel intervention for stroke~     rehabilitation examining effects of participation in visual arts activities on psychosocial~     outcomes after stroke.~      The investigators hypothesise that participation in a visual arts based intervention (CEI)~     will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving~     in-patient rehabilitation compared to viewing a portfolio of artwork.~      The results of the study will inform a sample size calculation for a full trial.~   "
74279|NCT02085083|"~     The transition from pediatric to adult IBD care can be stressful and wrought with challenges~     including access to care and establishment of new physician-patient relationships. There a~     few studies which characterize patterns of healthcare utilization during this critical~     period and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization~     in academic centers and optimized communication with patients during the pediatric-adult~     transition period is associated with lower hospitalizations and surgery. This hypothesis~     will be addressed by a randomized clinical trial to determine the impact of monthly regular~     telephone contact with an IBD Registered Nurse versus standard of care during the~     pediatric-adult transition period. Outcomes will include healthcare utilization,~     health-related quality of life, patient satisfaction, and treatment adherence over 12 months~     of follow-up. Randomization and analyses will be stratified by whether subjects were~     transferred to adult care in an academic center or in a community practice. We hope that~     this research will facilitate optimal delivery of healthcare during the pediatric-adult~     transition.~   "
74280|NCT02085070|"~     The purpose of this trial is to study the activity of MK-3475 in untreated brain metastases~     from melanoma or non-small cell lung cancer.~   "
74270|NCT02085213|"~     A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000~     women in the UK per year. This is where the placenta is not delivered spontaneously after~     giving birth. It is a major cause of postpartum haemorrhage (major loss of blood) which can~     lead to the death of the mother. The recommended treatment for RP is a surgical procedure -~     manual removal of placenta (MROP). This is a painful and unpleasant intervention for the~     women, involving additional hospital stay, and is an expensive outcome for the NHS. It is~     widely recognised that non-surgical management options for RP are limited and it has been~     recommended that research is needed into new medical treatments for RP. New effective~     treatments for RP would dramatically reduce the number of women requiring MROP with the~     operation being restricted to the small minority of women with particularly stuck placentae.~     The reduction in operative interventions would have cost benefits for the NHS and also for~     women in terms of increased satisfaction, less separation of mother and baby immediately~     after birth, and reduced morbidity.~      This study will try to prove the clinical and cost effectiveness of a known treatment for~     angina, Glyceryl trinitrate (GTN) used to treat RP. The investigators will compare GTN~     against a placebo (dummy treatment) in a randomised controlled blinded trial (GOT-IT).~      The GOT-IT Trial will be conducted in two phases. The first phase will involve an internal~     pilot study where the aim will be to test out and refine trial procedures in a small number~     of hospital sites. The second phase will be the main trial where recruitment will be~     extended to a larger number of hospitals in order to determine clinical and cost~     effectiveness.~   "
74271|NCT02085200|"~     The purpose of this study is to determine if stabilizing the scapula (shoulder blade) during~     a common shoulder stretch is more effective at improving shoulder range of motion than not~     stabilizing the scapula. Investigators hypothesize that scapular stabilization during~     horizontal adduction stretching will demonstrate greater gains in shoulder range of motion~     than stretching without scapular stabilization.~   "
74272|NCT02085187|"~     Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major~     impact on the lives of individuals. An essential element in the treatment of COPD is~     rehabilitation of which supervised training is an important part. However, not all~     individuals with severe COPD can participate in the rehabilitation provided by hospitals and~     municipal training centres due to distance to the training venues and transportation~     difficulties. The aim of the feasibility study was to evaluate an individualised home based~     training and counselling programme via video conference to patients with severe COPD after~     hospitalization with regard to safety, clinical outcomes, patients' perception,~     organisational aspects and economic aspects.~   "
74273|NCT02085161|"~     The primary objectives of the study are to explore the effect of treatment with orally~     inhaled tiotropium + olodaterol fixed dose combination with and without exercise training,~     and tiotropium comparing to placebo, on top of behavioural modification in improving~     exercise capacity in patients with COPD~   "
74274|NCT02085148|"~     The aim of this study is to determine at which dose regorafenib is safe for children and~     adolescents and also to investigate the pharmacokinetics (explores what the body does to the~     drug) of regorafenib (study drug) in children and adolescents. Additional objectives of the~     study are:~        -  To assess the tolerability of regorafenib in children and adolescents~        -  To assess whether there is any tumor response to regorafenib~        -  To assess the palatability and acceptability of regorafenib tablets in children~   "
74275|NCT02085135|"~     This is a Phase 3 study designed to evaluate the safety and tolerability of two titration~     schedules for ALKS 5461.~   "
74276|NCT02085122|"~     Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF)~     subjects, hampering performance in activities of daily living. In this context, noninvasive~     ventilation (NIV) has been used to minimize such impairment, increasing functional capacity~     Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A~     randomized crossover clinical trial with allocation concealment consisted of two~     experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30~     minutes of bi-level ventilation was performed. Any type of ventilator support was offered~     during control phase. Functional capacity was assessed by cardiopulmonary exercise test on a~     treadmill.~   "
74277|NCT02085109|"~     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein~     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still~     present. An additive strategy to further lower this residual risk may be via raising~     high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its~     major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that~     raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in~     cardiovascular disease (CVD) risk. To understand this it is important to know what are the~     targets and molecular mechanisms that underlie a shift to a HDL fraction with~     cardioprotective activities. There is increasing evidence that particularly the apoA-I~     proteins in the HDL fractions are atheroprotective. It is important to verify whether the~     effect of an intervention actually increases apoA-I production since that results in the~     formation of de-novo small pre-beta HDL particles that have full capacity to resorb~     cholesterol from the arterial wall and return this to the liver for secretion (reverse~     cholesterol transport). The investigators here propose to evaluate, in a double-blind human~     intervention study, the difference in intestinal apoA-I gene expression, of healthy~     subjects, after consumption of a high fat (HF) or low fat (LF) meal. Additionally the~     investigators propose to evaluate the effect of theobromine on intestinal apoA-I expression.~     Based on several studies, theobromine improved cardiovascular risk parameters among which an~     elevation in apoA-I and HDL cholesterol concentrations. It is however unknown whether this~     effect of theobromine originates from elevated apoA-I production, which suggest improved~     functionality, or decreased clearance, suggesting reduced functionality. The investigators~     therefore propose to also evaluate if the usage of theobromine is a better way to increase~     intestinal apoA-I mRNA and protein expression, than consumption of a HF meal. The~     investigators will do this in the same double-blind human intervention study. The~     theobromine will be added in a third arm in a LF condition.~      Study design: The proposed study will have a randomized, double-blind cross-over design. The~     total study duration will be 17 days, consisting of 3 experimental days with postprandial~     tests, each separated by a 1 week wash-out period.~      Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history~     of any gastrointestinal disorders or complaints.~      Intervention: During the three experimental days, subjects will consume a milkshake: one HF~     milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total~     follow-up during each of the postprandial tests is 5 hours.~   "
74278|NCT02085096|"~     Problem-solving therapy programs have been shown to be effective among parents of children~     diagnosed with cancer. Efforts have been made to apply this same strategy to~     spouses/significant others of men diagnosed with prostate cancer. The purpose of this study~     is to test the efficacy of problem-solving therapy on the spouses of prostate cancer~     patients.~   "
74289|NCT02084953|"~     The purpose of this study is to determine whether BMS-791325 has an effect on the~     electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).~   "
75673|NCT02066831|"~     The purpose of the study is to compare the effect of telemedical coaching versus telemedical~     control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical~     activity and quality of life in type 2 diabetes patients with poor glycaemic control.~   "
74281|NCT02085057|"~     Individuals with anorexia nervosa (AN) have long been observed to demonstrate symptoms in~     common with obsessive-compulsive disorder (OCD), in particular, an obsessive fear of normal~     weight leading to dangerous food restriction, as well as many compulsive rituals about food.~     Both AN and OCD are seriously handicapping and often resistant to conventional therapies.~     Given that the two conditions often co-occur and are associated with still unknown genetic~     risk factors, the aim of this project is to identify their shared and distinct patterns of~     brain activity.~      The investigators propose to use functional magnetic resonance imaging to compare brain~     response among adolescents with AN, OCD, and age-matched healthy individuals. Specifically,~     this study will investigate function of distinct brain circuits related to core aspects of~     these related disorders. The investigators use three tasks related to set shifting, global~     vs. local processing, and reward. Based on evidence of deficits in cognitive flexibility and~     ability to change behavior, the investigators hypothesize that adolescents with AN and with~     OCD will show hypoactivity of frontostriatal circuitry during cognitive tasks, and~     adolescents with AN will show hyperactivity in limbic regions in a reward task.~      This study is the first to directly compare brain activation patterns using functional~     neuroimaging in AN and OCD. The goal is to determine how abnormal brain activity relates to~     symptom formation, what accounts for shared characteristics amongst these disorders, and~     whether deficits in specific circuitry underlie their unique defining features. The study of~     shared and unique elements of functional brain circuitry reflects a new, emerging approach~     to the classification of psychiatric illness, one based on identifying unique combinations~     of biological risk factors that link related conditions. This approach is widely believed to~     be a critical step forward in developing more brain-relevant targeted strategies for~     preventative interventions.~   "
74282|NCT02085044|"~     The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF)~     distributions have a greater impact on children's health than the standard RUSF~     distributions during the hunger gap period (june to september). We estimated that the 12~     month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an~     administration only during the hunger gap period (4 month a year).~   "
74283|NCT02085031|"~     -  To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular~          stapler was the most common used method during laparoscopy-assisted total gastrectomy~          for gastric cancer, even though it was not totally laparoscopic surgery in which~          intracorporeal anastomosis should be performed.~        -  To gain potential clinical benefits from a smaller length of minilaparotomy and an~          easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y~          anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic~          total gastrectomy was adopted by experienced surgeons recently.~        -  However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally~          inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the~          safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by~          circular stapler based on a well designed randomized controlled trial is needed.~   "
74284|NCT02085018|"~     Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal~     lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract~     oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with~     the disease die after approximately 3 years. The most common, troublesome symptoms of IPF~     are breathlessness on exertion, and cough. No drug treatments have been unequivocally shown~     to improve the death rate, or to significantly impact upon symptoms, in IPF.~      In recent years it has been recognised that cough can be caused by small amounts of liquid~     coming up from the stomach and going down the wrong way into the lungs, a process commonly~     known as reflux. As liquid in the stomach is usually acidic, patients' lungs may~     repeatedly be exposed to small amounts of acid. Reflux is unusually common in IPF and could~     potentially contribute to the debilitating cough found with the disease. However there are~     many potential causes for cough in IPF.~      Stomach acid can be efficiently switched off by drugs called proton pump inhibitors, one~     of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF,~     omeprazole might be expected to reduce cough. The purpose of this study is therefore to test~     whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be~     randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the~     doctor will be aware which treatment has been given, ie this is a randomised double-blind,~     placebo--controlled trial. Patients' cough frequency will be measured before and after~     treatment and the change in cough frequency compared in those receiving omeprazole and those~     receiving placebo. Change in cough frequency is the main thing we aim to compare, but a~     range of other measurements will be assessed such as the numbers of patients eligible to~     take part, agreeing to randomisation and providing outcome data, patients' lung function,~     symptom scores, the amount of reflux, and the amount of inflammation in the lungs.~   "
74285|NCT02085005|"~     Primary Objective:~      Efficacy: To assess the progression-free survival rate at 10 months in patients on~     maintenance therapy with capecitabine plus aflibercept.~      Secondary Objectives:~      To evaluate:~        -  Efficacy: Progression Free Survival (PFS)~        -  Efficacy: Overall Survival (OS)~        -  Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid~          Tumors (RECIST version 1.1) criteria~        -  Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L~        -  Safety~      Exploratory Objective:~      To collect blood and tumor samples to perform investigations for potential biomarker~     testing.~   "
74286|NCT02084992|"~     This study will randomize participants with a diagnosis of congestive heart failure and at~     least one risk factor for hospitalization to either a tablet computer and web based disease~     management program or a telephone based disease management program. Both interventions are~     home based with heart failure education and symptom monitoring provided by nurse managers.~     The nurse managers are in close communication with both the participants and the~     participants' physicians . The components of the disease management program have been~     developed at Tufts Medical Center and the New England Quality Care Alliance with studies~     showing improved clinical outcomes, including reduced hospitalizations. The goal of this~     study is to transition this successful home monitoring and disease management program to a~     table computer and web-based implementation to both improve clinical outcomes (reducing~     hospitalizations and improving self-perceived health status) and improve provider-patient~     satisfaction. We hypothesize that the tablet computer based disease management will decrease~     heart failure hospitalizations.~   "
74287|NCT02084979|"~     This two-year randomized controlled trial of clinical outcomes seeks to evaluate the~     superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality,~     cost and outcomes of care over the usual care for adults referred from primary care clinics~     for psychiatric evaluation and treatment.~   "
74288|NCT02084966|"~     Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function~     as a type of optical biopsy, providing non-invasive cross-sectional images of tissue~     architectural morphology in situ and in real-time. This proposal will demonstrate that OCT~     has the ability to provide novel and valuable histopathological information regarding donor~     kidneys that can be used to predict post-transplant renal function. These investigations~     will result in a major breakthrough in increasing the number of healthy kidneys available~     for transplantation by making the most efficient use of available donor kidneys, eliminating~     the possible use of bad donor kidneys, providing an accurate measure of expected~     post-transplant renal function, and allowing better distinction between post-transplant~     immunological rejection and ischemic-induced acute renal failure.~   "
74290|NCT02084940|"~     PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age~     characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome~     is a serious problem in IVF since there is a high risk of developing ovarian~     hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The~     introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still~     maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH~     antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent~     paper reported its use also for the induction of multiple follicular growth in a program of~     oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist~     depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of~     developing OHSS in IVF cycles.~   "
74291|NCT02084927|"~     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,~     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological~     deficits and cognitive impairment after anterior skull base meningioma tumor removal.~   "
74292|NCT02084914|"~     Research question:~      Population: women with unexplained infertility. Intervention: endometrial scratching by~     pipelle for women with unexplained infertility.~      Comparison: to compare with non endometrial scratching for women with unexplained~     infertility.~      Outcome: the biochemical pregnancy rate.~      Research hypothesis:~      Null hypothesis: there is no difference in the rate of pregnancy between scratching and non~     endometrial scratching in women with unexplained infertility.~      Alternative hypothesis: there is difference in the rate of pregnancy between scratching and~     non endometrial scratching in women with unexplained infertility.~   "
74293|NCT02084901|"~     The use of a biodegradable polymer has the potential to reduce the sustained inflammatory~     response of the arterial wall, facilitating re-endothelialization and minimizing the risk of~     thrombus formation and late restenosis. In the study, we are going to two biodegradable~     polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by~     optical coherence tomography at 3 months after stent implantation.~      The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to~     Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The~     secondary endpoint is clinical outcomes up to 1 year.~   "
74294|NCT02084888|"~     The purpose of this study is to determine the prognostic impact of the presence of chronic~     total occlusions (CTO) of the coronary arteries in patients undergoing coronary angiography~     and PCI.~   "
74295|NCT02084875|"~     This study will evaluate the drug behavior and safety of a single dose of the 11 milligram~     tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken~     after eating a high fat meal (the effect of food). This will be compared to the drug~     behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550)~     modified-release formulation when taken after a 10 hour fast.~   "
74296|NCT02084862|"~     TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and~     efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided~     percutaneous tracheostomy.~   "
74297|NCT02084849|"~     The purpose of this study is to find out if radiology tests of the kidneys as opposed to~     glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function)~     follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for~     progression to renal failure (dialysis or transplantation) have been identified and include~     those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene~     (the inherited abnormality responsible for the majority of PKD), men as opposed to women,~     those with episodes of visible blood or increased protein in their urine, and women who have~     experience more than three pregnancies. Individuals who are diagnosed with PKD in the first~     year of life or in utero (before birth) are also at high risk for progression to renal~     failure.~      This study will also facilitate understanding of human diseases at the cellular and~     molecular level. We will be identifying genetic factors that may influence the severity of~     polycystic kidney disease (PKD). You are being asked to provide a sample of blood for the~     purpose of DNA or other biochemical analyses.~   "
74298|NCT02084836|"~     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular~     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension,~     gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the~     United States (Calle et al., 1999; Flegal et al., 2005). In the US, 65% of adults are~     overweight or obese (Hedley et al., 2004). Unfortunately, the treatment of choice for~     obesity (behavioral weight loss treatment) only results in a 10% reduction in body weight on~     average and most patients regain this weight within a few years (Jeffery et al., 2000).~     Further, most obesity prevention programs do not reduce risk for future weight gain (Stice,~     Shaw, & Marti, 2006). The limited success of treatment and prevention interventions may be~     due to an incomplete understanding of the processes that increase risk for obesity. Recent~     data suggest that obese adults show abnormalities in reward from food intake and anticipated~     food intake relative to lean adults, but the precise nature of these abnormalities is~     unclear and it has not been established whether these abnormalities predate obesity onset or~     are a consequence. It is vital to elucidate risk factors for obesity onset to advance~     understanding of etiological processes and determine the content of prevention and treatment~     programs.~      The goals of this study are to (1) determine whether adolescents at high-risk for obesity,~     by virtue of having two obese parents, show abnormalities in reward from food intake~     (consummatory food reward) and anticipated reward from food intake (anticipatory food~     reward) compared to adolescents who are at low-risk for obesity, (2) determine whether~     abnormalities in consummatory and anticipatory food reward increase risk for weight gain and~     obesity onset, (3) examine moderators that may amplify the relations of consummatory and~     anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory~     and anticipatory food reward in those participants who show obesity onset relative to those~     not showing obesity onset.~   "
74299|NCT02084823|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
74300|NCT02084810|"~     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence~     of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.~   "
74309|NCT02084693|"~     Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.~   "
74301|NCT02084797|"~     This primary aim of this study was to critically assess whether or not sweat water content~     and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone~     (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise.~     Secondary aims were to evaluate running performance and core temperature to further~     characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis~     during exercise. The primary hypothesis was that activation of the V2R in sweat glands would~     result in water reabsorption and fluid conservation during endurance exercise.~   "
74302|NCT02084784|"~     The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of~     early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a~     novel surgical navigation system.~   "
74303|NCT02084771|"~     The purpose of this pilot trial is to determine the safety and feasibility of using oral~     salt and water loading compared to intravenous saline for the prevention of contrast-induced~     acute kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT~     scan.~   "
74304|NCT02084758|"~     Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate~     solution) and the placebo, separated by a 1 wk washout period. The investigators will test~     the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic~     efficiency in patients with COPD compared to the placebo.~   "
74305|NCT02084745|"~     Introduction:~      Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea~     (transparent structure at the front of the eye) in patients who have failed or those who are~     expected to have poor results with traditional corneal transplantation.~      While the Kpro can offer dramatic improvement in vision, it is also associated with several~     complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of~     the most common complications after KPro surgery and can potentially cause irreversible~     vision loss.~      The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid~     inside the eye by bypassing the natural drainage system, is an effective option to lower the~     eye pressure in patients with KPro. Given the frequency and potentially devastating effects~     of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative~     measure. However, there is no consensus on when is the best timing to perform such surgery~     in relation to the Boston Kpro surgery.~      Hypothesis:~      For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the~     time of surgery, is more efficacious than at 6 months later, in the prevention of the~     progression of glaucoma and in maintaining better visual functions.~      Methods:~      We aim to recruit 60 patients over 2 years. Recruited patients will be randomly assigned to~     2 groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD~     implantation 6 months after the Boston KPro surgery.~      Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week~     1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit.~     Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo)~     will be performed on day 1, month 1, 3, 6 and 12.~      For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery.~     They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1.~      Results of visual acuity, visual fields, optic nerve evaluation and complications will be~     compared between the two groups to determine the better timing of GDD implantation.~   "
74306|NCT02084732|"~     Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and~     C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a~     rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in~     Colombia, 2010).~      Although this disease has a low rate of attributable mortality, the costs arising from~     treatment, monitoring, and disabilities among affected patients and their families are high~     for the health system.~      The therapeutic approach to differentiated thyroid cancer once it starts progressing is~     limited; there are no truly favorable treatment options for patients with advanced thyroid~     cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.~      Molecular biology now allows the identification of the effects of mutations and alterations~     in the proteins that participate in cell signaling which account for dedifferentiation,~     invasiveness, and the progression of neoplastic cells.~      VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be~     addressed by targeted molecular therapy. Its increased expression in differentiated thyroid~     cancer has been demonstrated and has been associated with increased growth, invasiveness,~     and shorter recurrence-free survival.~      Different agents are effective against this tyrosine kinase receptor; nevertheless, taking~     into account that it is not solely responsible for tumor progression, according to clinical~     study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as~     sorafenib and motesanib. These inhibitors have already been tested in phase II studies.~      Results from recent phase II research studies using these emerging treatment options have~     shown important effects in the therapeutic approach to other solid neoplasms.~      Information about the safety of this type of treatment is limited; a need for information~     regarding the use of new therapeutic approaches in Colombia is one of the contributions that~     the National Institute of Cancer can make to the country through this study.~   "
74307|NCT02084719|"~     Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use~     has been associated with a faster linkage to care and lower rates of loss to follow up.~     Rapid tests are also well accepted by patients and clinicians.~      No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C~     diagnosis is done through based on blood testing and the screening algorithm may require up~     to 3 visits to clarify the hepatitis C status.~      The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first~     step of the regular screening algorithm. With this test the initial screening and the~     confirmation test can be done in one visit.~      The primary endpoint of this pilot-project is to evaluate clinical characteristics of~     Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to~     compare them to those of the standard screening algorithm in a population of active or~     ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce~     the rates of loss to follow up and increase the linkage to hepatitis C specialized care.~     This last endpoint will be evaluated through phone call follow up 6 months after the~     screening.~      One hundred and fifty patients will be included. Half will be tested with the standard~     algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard~     algorithm.~      Results of group A will be used to determine the clinical characteristics of Oraquick HCV.~     Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided~     by the use of the rapid test and linkage to care of infected patients.~   "
74308|NCT02084706|"~     Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for~     the subdermal injection of lidocaine solution for anesthetic purposes. The device has been~     found effective in pain reduction during IV catheterization in adults and children and~     lumbar puncture in children when compared to placebo saline-jet injection. [1-4].~      We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml)~     injection could mitigate pain that occurs during and immediately following injection while~     preserving the post-injection pain relief of anesthetic injection. Furthermore,~     pre-placement of the jet-injected local anesthetic may obviate the need for the inclusion of~     local anesthetic into the triamcinolone injection. This would decrease the amount of fluid~     injected, which could have positive pain modulation by decreased tissue disruption.~      Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration~     of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml~     triamcinolone injection.~      Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an~     equal or superior means of pain reduction when compared to 2% lidocaine injection in the~     setting of trigger digit triamcinolone injections.~   "
74310|NCT02084680|"~     Introduction There is compelling evidence for scheduled home visits to improve newborn~     health. There is also a growing wealth of evidence to support the use of mobile phones as a~     public health tool in low and middle-income countries. UNICEF and WHO have recommended~     implementation of home visits for newborn care improvement. In sub Saharan Africa the~     evidence for a combined scheduled home visit and mobile phone technology to improve neonatal~     health is lacking. In this study the investigators aim to determine the effect of scheduled~     home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs)~     combined with mobile phone consultations on newborn care in Masindi, Uganda.~      Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in~     Uganda from May 2013 to June 2014. A mixed method data collection technique will be used.~     Our overarching hypothesis is that survival of the newborn requires a continuum of care from~     pregnancy to the newborn period. Eight health centres each will be randomly allocated to the~     intervention arm and a control arm. Five villages will be randomly selected from each of the~     catchment areas of the intervention health centres and one VHT purposively selected from~     each of the villages. Intervention arm will receive VHTs equipped with mobile phones making~     four scheduled home visits to women while the control arm will receive the standard care for~     prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger~     signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended~     newborn care practices. VHTs can also make instant telephone consultations with the midwife~     for a second opinion. A closed caller group for the mobile telephone consultation is already~     negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow~     lower tariff rates. Our primary outcome variables of interest are hygienic cord care~     (specifically application of substances on the cord), thermal care (specifically delayed~     bathing of the baby soon after birth), initiation of breastfeeding within one hour and~     avoiding pre-lacteal feeds. Secondary outcomes like completed four antenatal visits,~     institutionalized delivery were also assessed.~   "
74311|NCT02084654|"~     Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients~     with type 2 diabetes, has been associated with restoration of the first-phase insulin~     response when administered intravenously to patients with type 2 diabetes. In longer~     clinical trials, it is associated with progressive decreases in body weight, and improvement~     in the dyslipidemia that characterizes insulin resistance, although insulin resistance was~     not quantified. The investigators will seek to determine whether exenatide would have~     similar effects in individuals who were not diabetic. in particular, the drug effect on beta~     cell function and insulin sensitivity would be subject to less confounding by changes in~     blood glucose in the prediabetic population, allowing for clearer evaluation of the~     physiological effects of the drug on these metabolic endpoints. The investigators will~     compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and~     one group on exenatide and the other on placebo. The investigators will evaluate restoration~     of first phase insulin response, potential glucose lowering effects, including both reversal~     of prediabetes and hypoglycemia, and improvement in insulin resistance.~   "
74312|NCT02084641|"~     Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate~     that most of the excess morbidity from obesity is related to insulin resistance (IR). While~     total adiposity correlates with insulin resistance, not all obese individuals are IR. When~     obese IR individuals lose weight in response to caloric restriction, even moderate loss of~     body fat results in improved insulin sensitivity (IS). With massive weight loss, either~     dietary or surgical, even the most IR individuals can completely reverse their insulin~     resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There~     must be differences in the manner in which adipose cells/tissue respond to caloric excess~     and weight gain. One potentially unifying hypothesis with regard to obesity-associated~     insulin resistance is that those individuals who fail to respond to caloric excess/obesity~     with adequate adipocyte differentiation and expanded subcutaneous fat storage capacity~     develop increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering~     localized and systemic inflammation and ultimately insulin resistance in skeletal muscle.~      Clearly, the best way to examine the human response to obesity is to challenge overweight~     individuals with the need to store excess triglyceride in adipose tissue. Specific aims are:~        1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated~          with insulin resistance by comparing 1) cell size distribution; 2) gene markers of~          adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone~          vs IS individuals subjected to caloric excess.~        2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic~          fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS~          individuals subjected to caloric excess.~        3. Determine whether differences in inflammation and/or innate or adaptive immune response~          are associated with insulin resistance by comparing differences in resident dendritic~          cells, macrophages and their activation profiles, changes in T-cell subpopulations, and~          other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric~          excess via overfeeding.~        4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and~          insufficient angiogenic response in response to caloric excess.~   "
74313|NCT02084628|"~     This is an open-label, multi-center study involving babies 0-2 months of age who have liver~     problems (pathology) and need to have their liver and possibly, the bile ducts imaged using~     magnetic resonance imaging and injection of a contrast agent (dye). This agent is called~     Eovist. It has been marketed since 2004 and used in many countries all over the world.~      The baby will have blood tests before and after the imaging is done to make sure that there~     are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours~     after the injection will be obtained in order to measure how much of the dye is in the~     blood. The baby will have an intravenous line which can be used for the blood samples and~     will not need to be stick for the blood samples. Several radiologists will evaluate the~     images. The family doctor will be contacted to find out what was the diagnosis and treatment~     after the results of the MRI were known. Six months after the study, the parent(s)/legal~     guardian(s) will be contacted to make sure the that baby did not have any problems,~     especially with the skin, joints and eyes.~   "
74314|NCT02084615|"~     The purpose of this study is to determine whether aspirin taken in the perioperative period~     will increase the blood loss associated with open inguinal hernia repairs. A secondary~     purpose of this study is to determine if the aspirin administered in the perioperative~     period increases the risk of complications associated with open inguinal hernia repairs.~   "
74315|NCT02084602|"~     There is growing evidence of the emergence of P. falciparum resistance to artesunate (a~     derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to~     artemisinin would represent an alarming threat to the success of the antimalarial~     combination therapy in the region. The delayed clearance of parasitemia for more than 24~     hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia~     border.~      The purpose of this research study, is to assess the in vitro and in vivo efficacy of~     combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum~     malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia~     and other important outcomes.~   "
74326|NCT02084459|"~     The purpose of this randomized study is to find out whether using the Danish-developed~     nursing intervention guided self-determination (GSD) can improve life skills of the chronic~     pain patient.~      The hypothesis is using guided self-determination in the treatment of chronic pain patients~     will increase the life skills of the patients and thus their life quality in spite of pain.~   "
74328|NCT02084433|"~     The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized~     system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that~     anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid~     local anesthesia compared to the anesthesia via conventional technique by infiltration.~      Design: split-mouth design AND parallel-arm design~   "
74316|NCT02084589|"~     This is a prospective, randomized, double blind study, in which a comparison of patient~     controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and~     demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being~     investigated. The purpose of the study is the assessment of the efficacy of labor analgesia~     and maternal satisfaction.~      Written informed consent is obtained by all parturients. Non invasive monitor of blood~     pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal~     heart rate is being placed.~      The participants are randomized in two groups, both receiving the same drug (ropivacaine~     0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes.~     Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10~     minutes.~      All parturients have to be instructed to self administration of epidural bolus dose when~     they experience mild to moderate pain. Both parturient and anesthetist who conducts the~     study and treat breakthrough pain, are blind to group assignment.~      After the last suture, total volume of epidural infusions of PCEA, total infused drug of~     PCEA pump, number of delivered PCEA boluses and manual rescue doses are being calculated.~     Time of delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores,~     neonate pH and Hct of the patient (ABGS), as well as possible need of newborn~     cardiopulmonary resuscitation are also recorded.~   "
74317|NCT02084576|"~     To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac~     0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract~     extraction.~   "
74318|NCT02084563|"~     The objective of this study is to describe the prevalence and prognostic impact of the most~     common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid~     Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and~     Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or~     bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and~     storage.~      Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform~     protocol.~   "
74319|NCT02084550|"~     The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical~     outcome is wellknown. This catabolism is especially pronounced in patients with acute or~     chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with~     ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into~     both these categories.~      To prevent this undesirable catabolism, we will investigate the effects of intravenous~     administration of predominantly anabolic amino acids (with an amino acid content equal to~     breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism~     and intracellular signalling pathways.~      Twenty-four patients will be block-randomized by gender in this parallel-group, randomized,~     assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or~     saline. Metabolism before and after the intervention will be assessed by palmitate- and~     amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be~     analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a~     measure of cellular activity.~      With this study we hope to find evidence for anabolic effects of intravenous amino acids in~     j-pouch surgery for ulcerative colitis. The perspective is a potential for primary~     prophylaxis of surgical complications, reduction in the length of hospitalization, and~     subsequently optimized long-term functional outcome of the pouch.~   "
74320|NCT02084537|"~     Prospective, multi-center randomized controlled trial comparing EUS-Guided cystgastrostomy~     or cystduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy,~     in patients with symptomatic or infected WOPN.~   "
74321|NCT02084524|"~     Malnutrition priori a major abdominal surgery is frequent and increases morbidity and~     mortality. The management of malnutrition has an impact in reducing postoperative~     complications. However malnutrition is rarely detected and Guidelines infrequently followed.~      Recovery time and nutritional evaluation in elderly patients are major criteria in their~     postoperative management. Identifying malnutrition or malnutrition risk is fundamental to~     its treatment. It is therefore unsurprising that many validated tools for nutrition risk~     screening and nutrition assessment exist for the clinician to use in assisting with the~     accurate identification, referral and treatment of patients who are malnourished or at risk~     of malnutrition.~      And nutritional management must be adapted and based on this evaluation and evolution of the~     general status (Guidelines Grade A).~      A geriatric evaluation based on a screening of preoperative malnutrition should allow a~     better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN)~     guidelines.~   "
74322|NCT02084511|"~     To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution~     compared to placebo and the relative effectiveness compared to Celecoxib.~   "
74323|NCT02084498|"~     The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve~     patients with type 1 diabetes can achieve better metabolic control by counting~     carbohydrates, and that the metabolic control can be further improved with concurrent use of~     Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting~     will lead to better quality of life as a result of fewer restrictions when eating and less~     variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek~     Aviva Expert will lead to fewer hypoglycemic episodes.~   "
74324|NCT02084485|"~     The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in~     the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of~     inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for~     patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
74325|NCT02084472|"~     Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's~     essential drug list (EDL) but are not available to most rural patients. To assess whether~     accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized~     controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two~     separate sub-studies were conducted using a randomized controlled single (assessor) blind~     trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all~     patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG,~     petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and~     IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and~     antihistamines were continued as prescribed.~   "
74332|NCT02084381|"~     The medium cut-off dialysis membrane has been developed to provide a significantly extended~     molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane~     allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a~     still limited permeability for albumin (68 kDa).~      The main goal of this project is the evaluation of the new, highly porous and selective~     dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in~     hemodialysis mode and to study its potential to improve chronic inflammation.~   "
74333|NCT02084368|"~     The research is to study the effectiveness and safety of combined lumbar plexus and sciatic~     nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee~     replacement.There have be some papers which supported that combined lumbar plexus and~     sciatic nerve block may be more suitable for the old men.~   "
74334|NCT02084355|"~     Although opioid rotation is well known treatment modality in reducing pain and~     opioid-induced neurotoxicity, it is not established whether opioid rotation is more~     appropriate or opioid escalation is more effective in controlling significant pain in cancer~     patients under opioid medication.~      - The purpose of this study is to determine effective therapy out of opioid rotation and~     opioid dose escalation in patients with moderate to severe cancer pain who have been already~     treated with strong opioid.~   "
74335|NCT02084342|"~     Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss~     and blood transfusion requirements during spinal posterior fusion in adolescents with~     scoliosis. TXA acts mainly by inhibit the plasminogen activator.~      Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von~     Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type~     plasminogen activator (t-PA), which may cripple its hemostatic effect.~      The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis~     correction surgery, the blood loss and the transfusion need would be reduced significantly.~   "
74336|NCT02084329|"~     After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood~     hospital we have noticed that balance is improved when patients with mTBI wear a weighted~     compression vest. This follow up pilot study looks at the immediate effects of weighted~     compression vests on participants with altered balance after mTBI. Participants will be~     recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait~     list. Then each participant will perform a series of balance and walking tests under 2~     conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression~     vest. It will be randomized whether participants wear the vest on the first or second~     testing day. Participants will also be asked how confident they are about their balance and~     how anxious they felt performing the assessments after each testing session. We hypothesize~     that the weighted compression vest will improve fatigue and anxiety immediately and 24 hours~     after performing a complex task, and will improve static and dynamic balance, gait~     variability, and walking speed in patients with mTBI, during the tasks.~   "
74337|NCT02084316|"~     This study will evaluate the effects of a comprehensive approach (One4All) to increase the~     percentage of patients that receive their HIV testing results and counseling.~      Primary Hypothesis: The One4All approach will increase the proportion of individuals who~     have completed all tests to confirm HIV diagnosis and received counseling within 30 days of~     screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.~   "
74338|NCT02084303|"~     The investigators plan to study inflammation in the brain (neuroinflammation) in human~     patients with epilepsy using a novel, non-invasive technique that has been proven successful~     in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug~     with minimal side effects that is FDA-approved for the treatment of iron deficiency anemia,~     as the contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy~     patients who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for~     video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for~     curative brain surgery. During the hospital stay and after informed consent, the patient~     will receive a standard-dose intravenous injection of ferumoxytol, and undergo one session~     of MRI at 24-48 hours after the injection. The patient will also undergo a separate~     baseline MRI session (if not already done at DHMC) at admission or at more than four weeks~     after the injection but before any brain surgery. Brain regions that preferentially uptake~     ferumoxytol are localized by subtracting the post-injection MRI session from the baseline~     MRI session. The investigators will investigate whether these regions overlap with the~     epileptogenic focus, namely the region that generates epilepsy and is localized by video-EEG~     and other diagnostic measures. Lastly, for those patient participants who thereafter undergo~     brain surgery, DHMC neuropathologists will use special stains to detect and quantify~     neuroinflammation in brain tissue removed, and the results will serve as the reference for~     the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in~     detecting neuroinflammation.~   "
74339|NCT02084290|"~     Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on~     patients' treatment choice, persistence with chosen therapy, decision quality, cost of care,~     and outcomes~      Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand~     which treatments are right for them and will lead to a higher acceptance of appropriate~     therapy, improved persistence with chosen therapy, lower costs and improved clinical~     outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial~     to:~        1. Determine how the shared decision making program influences patients' choice of therapy~        2. Evaluate how the shared decision making program affects persistence with chosen therapy~        3. Determine how the shared decision making program affects decision quality~        4. Determine how the shared decision making program influences cost of care and clinical~          outcomes~      Expected Outcome and Impact: Investigators expect that this program will influence patients'~     choice of therapy, persistence with their preferred therapy, and lead to improved clinical~     outcomes. Investigators believe that this product can be successfully operationalized in the~     clinic to establish a new paradigm of how providers can communicate personalized treatment~     options to patients across a broad range of diseases.~   "
74340|NCT02084277|"~     The objective of this prospective study is to compare these two treatments (conventional~     brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will~     provide the better oral health related quality of life (OHRQoL) outcomes for patients during~     the initial orthodontic treatment compared with pretreatment.~   "
74342|NCT02084251|"~     GLP-1 analogues have been widely used because of their unique advantages (no risk of~     hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of~     peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with~     Exenatide as API).To improve the patients compliance and reduce potential adverse events~     associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be~     administered once weekly, was developed by PegBio Inc. In order to provide rational for~     dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic~     behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose~     escalating trial.~   "
74343|NCT02084238|"~     This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic~     lupus erythematosus.~   "
74344|NCT02084225|"~     The purpose of this study is to determine feasibility, perceived utility and sustainability~     of training local providers in ultrasound guided regional anesthesia for acute pain~     management in a limited-resource conflict setting.~   "
74345|NCT02084212|"~     The aim of this research is to assess current care by studying macular function using~     microperimetry and by then comparing visual acuity results with OCT (Optical Coherence~     Tomography) data.~      The examinations performed are those usually done in the follow-up of epiretinal membrane~     surgery, apart from microperimetry which is an examination of the central visual field.~     Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months~     and 6 months after the surgery. The consultation includes an assessment of visual acuity, a~     fundus examination an SD-OCT of the retina. The present protocol will require no additional~     visits. The microperimetry will be done in addition to the usual follow-up examinations~     after ERM surgery.~   "
74346|NCT02084199|"~     This will be an open label study to assess the influence of renal impairment on the~     pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations~     of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy~     controls.~      Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects~     with renal impairment and matched healthy controls will be evaluated.~   "
74347|NCT02084186|"~     The purpose of this study is to determine whether moxibustion is effective to mild and~     moderate ulcerative colitis and the effect of moxibustion on metabolism.~   "
74348|NCT02084173|"~     With the aging of western societies in the coming years combined with increasing alcohol~     consumption among elderly, the number of elderly with alcohol problems is expected to rise~     considerably.~      Elderly patients are often lonely; suffer from feelings of loss, fear to be a burden on~     their children and on society, and feel powerless. On the surface their alcohol related~     problems seem less severe that those of the middle-aged patients while in reality~     co-morbidity and social issues complicate alcohol dependency.~      Currently, no specific treatment tailored for alcohol use disorder among elderly is~     available. Consequently they receive either no treatment, are given brief advising from the~     general practitioner or are referred to treatment at specialized treatment institutions with~     no specific treatment for elderly.~      The investigators propose a study aimed at developing and testing an outpatient behavior~     therapy program for alcohol use disorders for seniors (60 years and older), which - if~     effective - can be easily implemented in routine care. Three centers from Denmark, Germany~     and USA (New Mexico) will participate. All three centers have a long and extensive~     experience with alcohol treatment and alcohol research. Patients fulfilling the DSM 5~     criteria for alcohol use disorder are eligible for the study.~      After informed consent participants will be randomly assigned to either Motivational~     Enhancement Therapy (MET), four sessions/one session per week or MET followed by Community~     Re-enforcement Approach (CRA), eight sessions/one session per week - thus 12 weeks of~     treatment in total. 50% will receive MET and 50% MET+CRA. Primary outcome is percentage of~     patients with abstinence or controlled use (alcohol intake of equivalent blood alcohol~     content equal to or less than 0.5‰.). A total of 1000 patients will be enrolled.~     Participants will be assessed with a battery of international validated instruments~     measuring drinking pattern as well as key elements of treatment.~      Participants are assessed before initiation of treatment, at the end of MET treatment (four~     weeks), at the end of MET+CRA treatment (12 weeks), at 6 months, and at 12 months.~   "
74349|NCT02084160|"~     The objectives of this study are:~        -  To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic~          decompensation events~        -  To evaluate the relationship between liver Biopsy and clinical outcome and show that~          the MBT has a better predictive ability of clinical outcome than liver biopsy.~        -  To evaluate the ability of the MBT to predict each of the individual liver related~          complications.~   "
74350|NCT02084147|"~     This randomized pilot clinical trial studies how well positron emission tomography~     (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed~     tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic~     diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI~     is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not~     yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients~     with cancer, cardiac disease, or neurologic disease.~   "
74351|NCT02084134|"~     During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a~     neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by~     making a small hole in the back of the nose into the bottom of the skull. The surgeon is~     able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.~      Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal~     failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure,~     and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons~     about the use of perioperative steroids in pituitary patients. Traditionally, all patients~     undergoing pituitary surgery were given steroids before, during, and after surgery because~     of the assumption that there would be some compromise in the amount of ACTH released by the~     pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH~     secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result,~     there are some centers that routinely give perioperative steroids to all patients undergoing~     pituitary surgery and there are some centers that do not routinely give perioperative~     steroids. There are several retrospective and prospective studies that have addressed this~     issue and have shown that withholding perioperative steroids is safe, but there has never~     been a prospective study comparing the two approaches.~      Objectives: The goal of this study is to prospectively compare two approaches to the~     perioperative management of patients undergoing transsphenoidal resection of a pituitary~     tumor or cyst. One protocol includes the routine use of perioperative steroids and the other~     does not. The investigators hypothesis, based on previous studies, is that patients who are~     adrenally sufficient do not routinely need to be treated with perioperative steroids. The~     investigators also hypothesize that the use of perioperative steroids may be associated with~     a higher rate of adverse outcomes~   "
74352|NCT02084121|"~     A subject was treated under compassionate use provisions under this study with facilitating~     cell therapy (FCRx) product manufactured using the CliniMACS (Miltenyi Biotec) device,~     rather than the Max Sep (Baxter) device.~   "
74376|NCT02083809|"~     Currently, there is very little research to identify ways to decrease blood loss during D&E~     (dilation and evacuation) procedures. The objective is to determine whether routine use of~     intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks~     gestation. To evaluate the hypothesis, investigators will perform a randomized,~     double-blinded, placebo-controlled trial. The patient will be followed until discharged from~     the postoperative care unit during which time patient satisfaction, pain score and~     postoperative bleeding will be assessed.~   "
74353|NCT02084108|"~     Introduction: Care of frail and dependent elders with multiple chronic conditions is a major~     challenge for health care systems. The objective of this study is to evaluate the effect of~     coordinating the existing structures in the private and public sector for the care of frail~     and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social~     issues. This approach is aimed at improving the coordination, continuity, quality and~     efficacy of care in this population, which presents a high risk of hospitalization,~     emergency room visits, institutionalization and mortality.~      Methods: Three-year cluster randomised controlled trial. A control group receiving usual~     care (follow up by primary care physician and home nursing service) will be compared to an~     intervention group that will be provided, in addition, in-home multidimensional geriatric~     assessment with access to a 24h/7 day a week call service, and coordinated long-term~     follow-up. Survival analyses will be conducted to compare the outcomes between groups.~      Primary outcome:~      - Hospitalizations: rates of first hospitalization, number, cause and length of stay.~      Secondary outcomes:~        -  Emergency room visits: rates of first visit, number and cause~        -  Institutionalization: number of patients~        -  Mortality: rate and number of deaths and place of death (home versus hospital)~   "
74354|NCT02084095|"~     Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance~     (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I)~     correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly~     reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS~     is independent of acromegaly intensity.~      The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but~     is just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through~     free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.~      Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF~     binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test~     acording to Bergman model. FFA will be directly measured in plasma.~   "
74355|NCT02084082|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release, both under fed and~     fasted conditions.~   "
74356|NCT02084069|"~     The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory~     agent can be effective in preventing from atrial fibrillation incidence in patients whom~     undergone open cardiac surgery for their heart valve repair.~   "
74357|NCT02084056|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release.~   "
74358|NCT02084043|"~     Using an adult lung bench model of non invasive ventilation, the aim of the study is to~     compare an experimental system of breath-synchronized vibrating mesh nebulizer to a~     conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled~     and lost doses.~   "
74359|NCT02084030|"~     The aim of this study is to perform a whole-genome linkage analysis for identification of~     the susceptibility loci for POCD~   "
74360|NCT02084017|"~     The purpose of this study is to investigate the current standard of wound care following~     vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and~     the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood~     flow to the lower limb(s).~      Negative pressure wound therapy consists of a closed, sealed system that produces negative~     pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is~     sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction~     is maintained by connecting suction tubes to a vacuum pump and waste collector.~      The investigators objectives are to determine whether there will be any reduction in~     surgical site infection and this potential reduction will influence length of hospital stay,~     emergency room visits, antibiotic use and need for re-operation.~   "
74361|NCT02084004|"~     The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride~     and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect~     the potential mechanism.~   "
74362|NCT02083991|"~     Balancing immunosuppressive treatment in organ transplantation in order to achieve effective~     prevention of rejection on one side and avoidance of negative side effects on the other side~     is a major challenge, leading to developing different immunosuppressive protocols.~     Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin~     Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular~     morbidity, nephrotoxicity and malignancies.~      The investigators believe that both avoidance of CS and minimization of CNI, while using~     Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and~     mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side~     effects, without increased rejection frequency in renal transplanted patients.~   "
74363|NCT02083978|"~     In this proposal, the investigators will focus on subcortical gray and white matter~     structures commonly found to be abnormal in schizophrenia. Thus, the investigators will~     evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as~     measures of structural integrity of the corpus callosum and its various subregions.~   "
74364|NCT02083965|"~     The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc~     administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The~     secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK~     assessment for up to 6 months for a continued treatment period.~   "
74365|NCT02083952|"~     Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born~     prematurely, and has been associated with a wide range of symptoms. These include~     irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung~     disease, and delays in growth and development. A novel approach to the mangement of GERD in~     infants is the use of an abdominal band, applying gentle pressure and possibly reducing the~     reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a~     swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia,~     oxygen declines, and pH (acid) changes.~   "
74367|NCT02083926|"~     -  Social Anxiety Disorder (SAD) is common and causes significant impairment.~        -  First-line treatments for Social Anxiety Disorder are only partially effective. Many~          SAD patients experience little or inadequate symptom relief with available treatments.~        -  Ketamine is a potent NMDA receptor antagonist. Ketamine represents an agent with a~          potentially novel mechanism of action for the treatment of anxiety disorders.~        -  Ketamine has demonstrated efficacy in the treatment of psychiatric disorders closely~          related to Social Anxiety Disorder including Major Depression, Bipolar Depression and~          possibly Obsessive-Compulsive Disorder.~      Ketamine represents the possibility to provide rapid symptom relief to patients with SAD and~     may provide the mechanism for future drug development to treat SAD more rapidly and~     effectively.~   "
74368|NCT02083913|"~     The aim of our study is to evaluate the feasibility of a supervised training session using~     telehealth in the Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke~     (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of~     subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual~     care, subjects will perform additional sessions of supervised endurance and resistance~     exercise training. Subjects will be instructed to perform two supervised exercise sessions~     per week with telehealth plus one without supervision during 12 weeks. The following~     outcomes will be assessed before and after the telePreSET, then 12 months after bariatric~     surgery: 1- physical fitness (6MWT, maximal strength, symptom-limited cardiac exercise~     test); 2-health related quality of life (Laval questionnaire); 3-weight, height, body~     composition (bioelectrical impedance scale); 4-comorbidities and metabolic parameters (files~     and blood samples); 5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical~     activity (GPAQuestionnaire and actimeter). The feasibility will be assessed with a~     satisfaction questionnaire concerning physical activity management, dropout and compliance~     rates, as well as the number of injuries and accidents. The results of this research will~     give us preliminary data for future projects in order to improve support of bariatric~     surgery candidates to assure optimal results for their health. Also, we will contribute to~     the advancement of scientific knowledge, absent in the current literature in this~     population.~   "
74369|NCT02083900|"~     Prospective Randomized double-blind controlled trial comparing the healing rate, infection~     rate, pain score, ease of care and scar formation of Banana leaf dressing versus~     hydrocolloid dressing.~   "
74370|NCT02083887|"~     Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a~     safe and effective vaccination strategy against malaria. The vaccines have been found to be~     well tolerated when tested in Gambian adults, young children and infants, who are at risk of~     severe malaria. Both vaccines will be given to participating infants at the same time as~     some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and~     still helpful in making the body's defense system respond.~   "
74371|NCT02083874|"~     Single subject repeated measures design of an open label administration of Cannabidiol (CBD)~     to 5 participants withdrawing from cannabis use in an inpatient setting. 300mg of CBD will~     be administered once on day 1, twice on days 2-5 and once on day 6. Participants will be~     discharged on day 7. CBD will be administered orally in capsules.~   "
74372|NCT02083861|"~     The purpose of this study is to measure the effectiveness of a wearable therapeutic~     ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of~     the device to reduce pain, increase mobility, increase range of motion and muscle strength~     of the affected leg, and improve quality of life in patients with knee osteoarthritis will~     be evaluated.~      While the use of ultrasound to treat pain is established in the field, the ability to~     deliver low intensity, therapeutic ultrasound on a daily basis is new. The use of a wearable~     ultrasound device to deliver daily, low intensity, long duration ultrasound has been~     approved by the FDA for pain relief, relief of joint contracture, relief of muscle spasm,~     and increased circulation; however, it is not yet indicated for relief of knee~     osteoarthritis. The interventional device in this study is self-applied by the patient and~     worn daily for 4 hours of continuous therapy.~   "
74373|NCT02083848|"~     Background of the study: The accurate assessment of local cervical cancer spread (i.e.~     invasion) is of clinical importance for staging and treatment considerations. For example,~     if parametrial invasion is absent, radical surgery is the treatment of choice for tumors~     less than 4cm in diameter. However, if such invasion is present, the patient has become~     inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part~     of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to~     relatively frequent false-negative findings a risk of understaging and under-treatment~     occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the~     initial surgery, causing increased morbidity and treatment associated risks. For higher~     stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local~     tumor spread could enable individualized dose(volume) and field modifications.~      Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI~     sequences, which use a combination of an endorectal and external coil, to image the~     (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.~      Study design: The proposed study is an investigator initiated, single center, prospective~     pilotstudy.~      Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA~     of IIB will be included.~      Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI~     sequences of the (para)cervical area which allow qualitative assessment of the loco-regional~     invasion of cervical cancer.~   "
74374|NCT02083835|"~     PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing~     and analysing clinical and patient-reported outcome data of postoperative pain.~   "
74375|NCT02083822|"~     The survival of premature babies increased during the last decades. However, the~     neurocognitive long term development of these children is worrying, as demonstrated by~     EPIPAGE 1 study.~      These children present high risk of deficits such as cognitive deficits, adaptive~     malfunction, behavior disorders and difficulties in school learning.~      Understanding the specific neuropsychological disorders at the origin of these deficits is~     an important objective. Studies realized at school age showed that many premature children~     have executive functions (EF) disorders. However the specific nature of these disorders and~     the neuropathology associated are unknown.~      The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA~     and to correlate MRI findings with executives functions and neurodevelopmental outcome~   "
74377|NCT02083796|"~     The hypothesis of this study is that thoracic spine manipulation would reduce pain in~     subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects~     with impingement symptoms and in asymptomatic subjects. With this study, the investigators~     want to answer if possible changes in scapular motion and muscle activity following a TSM~     depend on the symptoms or if it is generic to individuals without shoulder dysfunction and~     not specific to subjects with shoulder impingement.~   "
74378|NCT02083783|"~     The purpose of this study is to determine whether TRI102 is effective in the treatment of~     Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.~   "
74379|NCT02083770|"~     Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study~     is to develop and test programs designed to reduce barriers and increase facilitators~     associated with cancer clinical trials participation for Hispanic Americans.~   "
74380|NCT02083757|"~     Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous~     partial pressure of oxygen (PtcO2) in the critically ill patients.~   "
74381|NCT02083744|"~     The long-term goal of this research is to determine whether a psychoeducational intervention~     will support self-care behaviors in Hispanic patients with heart failure. The specific goal~     of this study is to determine whether a culturally-appropriate psychoeducational~     intervention in Hispanic patients with heart failure, compared to a control group, will~     improve heart failure knowledge and self-care behaviors.~      We hypothesize that patients who receive the intervention will have improved heart failure~     self-care behaviors and depression scores as measured by the Self-Care Heart Failure Index~     and Patient Health Questionnaire.~   "
74382|NCT02083731|"~     The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the~     treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem~     cell transplantation (allo-HSCT).~   "
74383|NCT02083718|"~     The purpose of this study is to evaluate the utility of treating patients experiencing poor~     graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte~     Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with~     ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first~     objective was to evaluate the effect of such treatment on poor graft function, and second~     object was to investigate the safety of such treatment.~   "
74384|NCT02083705|"~     Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual~     inflations (3:1) per minute in newborns. The study aimed to determine if CC s during~     sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated~     3:1 resuscitation.~   "
74385|NCT02083692|"~     The purpose of this study is to assess the effect of metformin in tumor metabolism in~     patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20~     expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.~   "
74386|NCT02083679|"~     This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered~     in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung~     Cancer (NSCLC).~      The sponsor decided to discontinue the development of Sym004. Also the decision was made to~     discontinue the development of Sym004 in NSCLC indication. The decision to discontinue~     Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a~     result of the early discontinuation of the trial during the dose escalation part, the~     expansion cohort will no longer be performed hence the pre-specified secondary endpoints are~     not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March~     2015.~   "
74387|NCT02083666|"~     The main purpose of this study is to assess the safety and tolerability of SOBI002 in~     healthy volunteers following single and repeated administration.~   "
74388|NCT02083653|"~     This is a Phase 2, open-label, 3-arm trial of two Sym004 doses (Arms A and B) and a control~     group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance~     to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).~   "
74389|NCT02083640|"~     This study is to assess the relative bioavailability of palbociclib hard gelatin capsule~     formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule~     formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard~     gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg~     oral doses under fed conditions in healthy volunteers.~   "
74390|NCT02083627|"~     This study will assess the effect of multiple doses of fidaxomicin on the single dose~     pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and~     tolerability of multiple doses of fidaxomicin in the presence of a single dose of~     rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses~     of fidaxomicin and its metabolite OP-1118.~   "
74391|NCT02083614|"~     The effect of clamping the indwelling urethral catheter before removal is an unsettled issue~     in clinical practice. No studies have done before in the patients with gynecologic cancers~     who received radical hysterectomy. We hypothesized that clamping the catheter would decrease~     the rate of recatheterization. In addition, the feeling of urination during clamping is~     correlated with lower rate of recatheterization after removal.~   "
74392|NCT02083601|"~     The current study will implement and evaluate a multi-component, psychoeducational~     intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two~     hypotheses will be tested. First, caregivers who participate in the intervention group will~     demonstrate better outcomes than caregivers in the control group. Second, children with SCI~     whose caregivers participate in the intervention group will demonstrate better outcomes than~     children with SCI whose caregivers participate in the control group.~   "
74393|NCT02083588|"~     Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in~     the prime of life, causing severe reduction in quality of life and productivity, as well as~     social isolation, anxiety, and depression. The purpose of this study is to explore the~     efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators~     attempt to assess the effect of dTMS on the perception and modulation of pain in patients~     suffering from FMS.~   "
74394|NCT02083575|"~     role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.~   "
87748|NCT01908790|"~     The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter~     that estimates venous oxygen saturation.~   "
74396|NCT02083549|"~     The purpose of the study is to evaluate the efficacy of the University of Rochester Medical~     Center's current Massive Transfusion Protocol.~      Upon arrival of trauma level one designated patients the treating team evaluates the~     patient's injuries. If the patient is initiated under the facilities Massive Transfusion~     Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in~     the study. Study procedures include collection of a blood sample following the transfusion~     of each shipment, through shipment 5, of blood products outlined in the current Massive~     Transfusion Protocol.~      Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic~     state through resuscitation. One final blood sample will be collected 24 hours following the~     discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.~      Due to the critical need for medical intervention, consent procedure will be waived at time~     of enrollment. An authorized representative for the patient will be identified and~     approached to obtain consent for use of data collected.~   "
74397|NCT02083536|"~     The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and~     determine the recommended phase II dose of combining the effect of LDFWART following~     administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant~     ovarian cancer.~   "
74398|NCT02083523|"~     This study will use a pilot test format to examine the efficacy of a brief Motivational~     Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE~     (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance~     abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.~   "
74399|NCT02083510|"~     The aim of this trial will be to determine an effect-size for the administration of chronic~     low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density~     lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of~     4-6 weeks.~   "
74400|NCT02083497|"~     To evaluate the influence of different types of ankle taping in dynamic equilibrium and the~     electrical activity of the support member during the sporting gesture kicking muscles.~   "
74401|NCT02083484|"~     This is an expanded access program (EAP) for participants who have progressed after prior~     systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1~     (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated.~     Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475)~     clinical trial with the exception of a participant enrolled in the pembrolizumab protocol~     MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such~     participants will be eligible to participate in the EAP, regardless of prior treatment with~     a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.~   "
74402|NCT02083471|"~     Egg, milk and cereal allergies are the most important food allergies in Finnish children,~     the prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained~     in to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI)~     provides a treatment option in children with continuing allergy with high success rates. The~     study aims at specific oral tolerance induction in adults allergic to cow's milk or hen's~     egg. Oral immunotherapy involves taking very small amounts of the allergen, and slowly~     increasing the amount. Consequently, an elimination diet may be wholly or partially~     cancelled, without the fear of serious allergic reactions. Another aim is to explore changes~     in antibody-mediated and cell-mediated immune response to individual components of cow's~     milk and egg allergens during tolerance induction and compare these with the effect of the~     treatment.~   "
74403|NCT02083458|"~     The central line placement is the widespread procedure performed in the intensive care and~     emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters,~     administration some medications, renal replacement therapy, parenteral nutrition and~     hemodynamic monitoring.~      The procedure is performed by percutaneous puncture of large vein of the neck and the thorax~     - internal jugular vein or subclavian vein, then insertion of guidewire through the needle~     and placement of the catheter over the guidewire. The tip of the catheter is situated in the~     superior vena cava.~      There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most~     frequently cannulated veins in landmark-based approach are internal jugular and subclavian~     vein. The cannulation of the axillary vein is not common procedure in the intensive care~     unit, mainly due its complicated original technique.~      The primary intention of this study was to describe and assess usefulness and safety of the~     new landmark-based technique of catheterization of the axillary vein in patients admitted to~     the intensive care unit.~   "
74404|NCT02083445|"~     Circulating progenitor cells (CPC) treatments may have great potential for the recovery of~     neurons and brain function. Our group has reported how exposure to intermittent hypobaric~     hypoxia with superficial muscle electrostimulation is able to increase the concentration of~     CPC in peripheral blood in humans. Therefore, we believe that through physical activities~     and exposure to intermittent hypobaric hypoxia for a period, it will increase CPC in the~     blood of subjects who have suffered a severe Traumatic Brain Injury (TBI) one or more years~     ago, promoting regeneration and functional and cognitive recovery. The study primary~     end-point is to improve physical or psychological functioning of participants with TBI with~     a program of exercise, muscle electro-stimulation (ME) and/or intermittent-hypobaric-hypoxia~     (IHH). Secondary end-points are to increase and maintain CPC and also to study their~     possible relationship with physical or psychological improvement of participants with~     Traumatic Brain Injury (TBI). In order to achieve these objectives investigators have~     designed a randomized controlled trial that will include those patients who suffered severe~     TBI more than one year previously with physical or psychological sequelae. Exercise, muscle~     electro-stimulation (ME) and/or intermittent hypobaric hypoxia (IHH) programs will be~     applied during twelve weeks. Psychological and physical stress tests will carry out before~     and after the program and CPC will measure at the beginning, every two weeks, and at the end~     of the program.~   "
74504|NCT02082119|"~     To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy,~     concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.~      Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.~      Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant~     chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.~   "
74405|NCT02083432|"~     The aims of the study: to explore the possible effectiveness of cognitive behavior treatment~     (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia~     (DSM-IV), when performed by specially trained dentists.~      The patients diagnosed with intra-oral injection phobia according to the diagnostic manual~     DSM-IV. The effect of cognitive behavior therapy when performed by specially trained~     dentists will be evaluated. Patients referred to the Centre for Odontophobia, and who meet~     the inclusion criteria, will be allocated to an immediate treatment group (test group) and a~     waiting list group (control group) of 30 subjects in each group. After treatment they will~     be followed up during a 1-year period.~      Hypotheses are formulated based on the literature and previous population and treatment~     studies of similar designs among adults at the Centre for Odontophobia.~   "
74406|NCT02083419|"~     Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for~     heart failure and those suffering from arrhythmias. The purpose of this research study is to~     determine the effect left-ventricular pacing has on patients who have a ventricular assist~     device.~   "
74407|NCT02083406|"~     A single dose study to investigate how different formulations of OZ439 co-administered with~     PQP tablest are processed by the body when taken without food~   "
74408|NCT02083393|"~     To observe changes of circulating and tissue dendritic cells in acute lung injury,including~     invasive aspergillosis pneumonia~   "
74409|NCT02083380|"~     A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability~     and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in~     patients > 0.5 years and <= 70 years of age with uncomplicated Plasmodium falciparum malaria~     in Africa and Asia (Vietnam).~      Interim analyses for futility were planned. Adults and children will be included through~     progressive step-down in age following safety review by an independent safety monitoring~     board (ISMB).~      If the study were to meets its efficacy objectives, this will inform dose setting for Phase~     III studies.~   "
74410|NCT02083367|"~     Investigating the impact of hepatic encephalopathy on default mode networks within the brain~     to provide more clues with understanding the physiology of consciousness and predicting the~     reversibility of comatose states.~   "
74411|NCT02083354|"~     This is a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and~     trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or~     metastatic Acral lentiginous or cutaneous melanoma. This study will evaluate the objective~     response rate (ORR), progression free survival (PFS), duration of response, overall survival~     (OS), safety and efficacy, to assess steady state (all subjects) exposure to dabrafenib,~     dabrafenib metabolites, and trametinib and characterize the population pharmacokinetics (PK)~     and pharmacodynamics (PD) of dabrafenib and trametinib. Subjects will be enrolled and will~     receive dabrafenib 150 milligram (mg) orally twice daily and trametinib 2 mg orally once~     daily. Treatment will continue until disease progression, death, unacceptable toxicity, or~     withdrawal of consent, or study closure. After treatment discontinuation, subjects will be~     followed for survival and disease progression as applicable.~   "
74412|NCT02083341|"~     Muscle tension dysphonia (MTD) is a disabling voice disorder which causes severe voice~     change, neck pain, and voice fatigue. Current therapy modalities to treat these disorders~     include multiple visits to a qualified speech language pathologist (SLP) for rehabilitation~     with voice exercises and focused laryngeal/neck massage. Access to these services is~     difficult with long waitlists and often not covered by current public health insurance or~     locally available to many patients in Ontario. The goal of this study is to demonstrate a~     reduction in symptoms and improvement in vocal function by applying an external vibration~     device to key sites (e.g. jaw, neck, skull base) commonly identified as a source of abnormal~     muscle tension and injury in certain voice disorders, specifically MTD.~      This study will also investigate the effect of external vibration on the voice quality in~     classically trained singers (CTSs). Certain desirable acoustic qualities in a singers' voice~     are only accessible when the larynx and its extrinsic muscles are in a relaxed state. Muscle~     misuse and vocal strain are common problems in performers, which can result in conditions~     that require surgery and speech therapy, and may lead to a loss of income. Similar to vocal~     warm up exercises which contribute to the prevention of vocal injury, external vibration is~     expected to improve muscle perfusion in an acute setting and may have a direct effect on~     vocal fold cover viscosity.~      Both study groups will be randomized to receive either the external vibration device or a~     sham device. The sham device looks identical to the experimental device but has the~     vibration component removed.~   "
74413|NCT02083328|"~     The aim is to investigate the influence of caffeine on heart rate variability and on~     performance in a 3 min exercise test in different population groups (able-bodied, paraplegic~     and tetraplegic subjects).~      In general, the investigators are interested in the differences between the heart rate~     variability before and after caffeine supplementation and if the subjects exercise~     performance is enhanced using this type of supplementation. Another objective is to see~     whether there are differences between able-bodied and disabled subjects.~      Tetraplegic subjects showed in some previous studies no Low-Frequency-component (LF) for~     heart rate variability and no increase in catecholamines after the ingestion of caffeine.~     Therefore the investigators think, that tetraplegic subjects won`t show any ergogenic effect~     in exercise performance after the intake of caffeine. On the other hand, paraplegic subjects~     should show similar differences of heart rate variability after the ingestion of caffeine as~     able-bodied subjects. Paraplegic subjects should benefit from caffeine supplementation in an~     increase in exercise performance.~   "
74414|NCT02083315|"~     This study is designed to compare TRV130 to placebo and morphine to learn about its effects~     on pain relief and side effects.~   "
74415|NCT02083302|"~     The purpose of this study was to examine the impact of a bystander intervention education~     program on college students' attitudes and behaviors associated with bystander intervention~     and sexual violence.~   "
74416|NCT02083289|"~     The primary objectives of this study are to compare the safety, tolerability, and mean~     change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to~     latanoprost 0.005% following ocular instillation once every evening for 28 days.~   "
75688|NCT02066623|"~     The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety~     as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold~     system in patients suffering from coronary artery disease.~   "
74417|NCT02083276|"~     The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis~     infection has been macrolide antibiotics in the form of azithromycin, and alternatively~     tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a~     single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg~     doxycycline a day. However, recent studies have reported increasing treatment failure that~     may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is~     evolving. Research regarding other bacterial species indicates a high frequency of mutation~     based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma~     genitalium infections. There has only been case reports of tetracycline resistance among~     human Chlamydia isolates, but a recent study suggest that there might be decreasing~     effectiveness also for doxycycline. Veterinaries has for several years observed increasing~     prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population~     there is promiscuous horizontal gene transfer.~      If the current trend of declining cure rates continues, the investigators might face a~     situation where there are no documented and effective treatments for Chlamydia trachomatis~     infections. This underline an urgent need to expand the number of documented treatment~     options and mecillinam seems to be one of the options that warrant further investigation.~      The objectives of this study is to prove the concept of treating genital Chlamydia~     trachomatis with mecillinam (Pivmecillinamhydrochlorid).~   "
74418|NCT02083263|"~     With the use of Non invasive ventilation the patients with cystic fibrosis will have better~     lung function (FEV1).~   "
74419|NCT02083250|"~     The goal of this clinical research study is to evaluate the safety of combining vorinostat~     (also called SAHA) with fludarabine, clofarabine, and busulfan.~   "
74420|NCT02083237|"~     Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI~     experience cognitive changes, most typically affecting memory; that are greater than those~     experienced in normal aging. However, these cognitive changes in MCI, unlike in dementia,~     are not significant enough to markedly interfere with functional independence. In addition~     to cognitive change, some people with MCI also experience elevated symptoms of depression~     and anxiety, which adds to their risk of developing dementia. Close family are also impacted~     by their relative's MCI and show mild physical (e.g., increased incidence of systemic health~     problems such as high blood pressure) and mental health declines (e.g., elevated symptoms~     associated with depression and anxiety) that are similar, though not as severe, to those~     experienced by caregivers of a relative with dementia. Programs aimed at behavioural~     intervention have real potential to reduce and/or prevent negative health outcomes~     associated with MCI and future dementia by promoting positive behaviour changes. We wish to~     scientifically establish the utility of a behavioural intervention aimed at addressing the~     needs of both the person with MCI and their close family member, with the ultimate goal of~     lowering current and future susceptibility to mental health declines and chronic disease in~     people living with MCI. We have an 8 session (16 hour) program, where participants with MCI~     and their close relative are together for the first half of each session, which is devoted~     primarily to enabling positive lifestyle choice. In the second hour the group splits up,~     with MCI clients engaging in memory training while their close family member participates in~     a psychosocial intervention.~   "
74421|NCT02083224|"~     Clinical cancer genetics is an emerging new field in medical oncology, and has been~     incorporated into routine oncology practice in many leading medical institutions in North~     America and Europe. Cancer genetics is the study of genetic factors contributing to~     carcinogenesis. In the last 5-10 years, genes responsible for various well-defined~     hereditary cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary~     breast and ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the~     mismatch repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis~     colorectal cancer (HNPCC). One of the goals of a clinical cancer genetics service is to~     identify families at risk for hereditary cancer syndromes, provide genetic counseling, and~     offer genetic testing when appropriate. The identification of causative genes in hereditary~     cancer syndromes together with the advent of genetic testing is starting to have an impact~     on clinical management. The ability to identify a gene mutation in a cancer family allows~     predictive testing, stratifying at-risk family members into carriers who will benefit from~     aggressive surveillance and/or preventive options, and non-carriers who may be spared~     unnecessary surveillance. Appropriate use of genetic testing will ultimately result in~     medical cost reduction.~      The investigators hypothesize that the clinical characteristics and genetic factors~     contributing to hereditary cancer in the Singaporean Asian population are distinct from~     those described for Western patients.~   "
74422|NCT02083211|"~     This study evauates the global survival of patients following administration of mAb~     Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy,~     after relapsing from chemo-radiotherapy.~      It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be~     assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After~     progression, a second line chemotherapy based on carboplatino/taxol will be administered in~     both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until~     limiting toxicity or ECOCG >3.~      Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be~     evaluated using MRI.~   "
74423|NCT02083198|"~     This observational study evaluates the impact of high and low chloride containing IV fluids~     on administrative and clinical outcomes. The study uses a large electronic health dataset~     and examines patients receiving fluid replacement and resuscitation. The hypothesis is that~     high chloride solutions are associated with adverse outcomes as measured by administrative~     data and by clinical parameters.~   "
74424|NCT02083185|"~     This is a 3-arm, randomized, open-label, parallel group study of TAK-385, together with a~     leuprorelin observational cohort, in patients with prostate cancer who require first-line~     androgen deprivation therapy (ADT).~   "
74425|NCT02083172|"~     The primary objective of this study is to evaluate the agreement between hemodynamic~     measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd.,~     Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography~     (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.~   "
74426|NCT02083159|"~     Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the~     liver, which is one of the most common forms of chronic liver disease in developed~     countries. In western countries, the prevalence of NAFLD in the general population is~     estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn`t~     been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet~     strategy.~      Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been~     reported to share structural homology with adiponectin. To date, 15 CTRP family members have~     been found that might play major roles in glucose metabolism and inflammation.~      The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean~     men and women.~   "
74427|NCT02083146|"~     Now, adipose tissue is established as an active endocrine organ that controls systemic~     energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis~     factor-related protein (CTRP) family have been reported to share structural homology with~     adiponectin. To date, 15 CTRP family members have been found that might play major roles in~     metabolism and inflammation. The investigators tried to clarify the relationship between~     CTRP family and coronary artery disease (CAD) in Korean men and women.~   "
74428|NCT02083133|"~     The purpose of this study is to assess whether the current recommendation for a 50% dose~     reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or~     on hemodialysis results in an increased number of hypoglycemic episodes.~   "
74429|NCT02083120|"~     The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive~     hypercapnic respiratory failure are still not sufficiently known yet.~      The aim of this study is a step-by-step generation of physiological data about gas exchange~     and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to~     provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise~     capacity, quality of life and gas exchange in a long term home treatment compared to a~     standard low flow long term oxygen therapy (LOT).~      Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous~     carbon dioxide partial pressure (PCO2) after four weeks of treatment.~   "
74430|NCT02083107|"~     The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1~     synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol~     before caesarean section to decrease blood loss during and after the operation.~   "
74431|NCT02083081|"~     In the southwest region of Alaska where the project takes place, 79% of Alaska Native women~     smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy~     appears to be a high risk period for initiation of tobacco use, primarily ST, among women~     reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the~     entire community, not only pregnant women, to address social norms about tobacco use may be~     effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component,~     theory-based intervention for reducing tobacco use during pregnancy, incorporating both~     individually targeted and community level components delivered by female elders Native~     Sisters. The intervention builds on effective community and individual-based approaches for~     tobacco cessation and lay health advisor approaches for cancer prevention among Native~     American women. As part of the intervention, a social marketing campaign including digital~     stories and other small media will be developed with community feedback. Individually~     targeted components will be six 30-40 minute telephone or home-based peer counseling~     sessions with pregnant women.~   "
74432|NCT02083068|"~     This is a randomized, double-blind, controlled, which seeks to compare two groups of~     volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a~     synthetic derivative of the CS protein of Plasmodium vivax in order to determine their~     protective efficacy. Then volunteers will be subject to an infectious challenge to assess~     the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus~     mosquitoes.~   "
74433|NCT02083055|"~     The aim of this study was to evaluate the positive anesthetic properties such as reduce~     intraoperative analgesic requirement, time to extubation and recovery, and early~     postoperative pain of dexmedetomidine used as a hypotensive agent compared with~     nitroglycerin.~   "
74434|NCT02083042|"~     This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to~     assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a~     protective cut-off value for CMV reactivations/disease in kidney transplant recipients.~      Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to~     assess the functionality of a network of clinically relevant CMV-reactive effector cells. It~     is based on the stimulation of peripheral blood mononuclear cells (PBMC) with~     urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent~     quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ~     ELISpot.~   "
74435|NCT02083029|"~     The investigators' hypothesis is that dysregulation of autonomic function, as revealed~     during a simulated dive reflex, may result in an attenuation of the heart rate response to a~     greater degree in asthmatics who collapse during exacerbations of asthma than that seen in~     healthy individuals and in asthmatics without a history of syncope. The investigators will~     test this by assessing autonomic function through a dive reflex protocol.~   "
74436|NCT02083016|"~     Ultra-high density mapping with multielectrode catheter may improve slow conduction channels~     identification in ventricular tachycardia substrate ablation procedures compared to~     conventional point by point mapping.~      This study compares the ability of both mapping catheters to detect slow conduction channels~     in areas of myocardial scar and their utility to assess substrate modification after~     ablation.~   "
74437|NCT02083003|"~     It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine)~     potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA~     receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This~     research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic~     cholecystectomy performed in an ambulatory setting.~   "
74817|NCT02078024|"~     We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to~     IVM alone given annually, which is the current standard for mass drug administration (MDA),~     is more effective in sterilizing adult worms. We will also address whether IVM plus ALB~     given twice per year is superior to IVM given once per year or twice per year.~   "
74438|NCT02082990|"~     Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of~     time in daily practice has been identified as a barrier for the wide implementation of BI.~     There is growing evidence that e-health tools such as web based BIs can be an efficient~     alternative to standard face-to-face BIs and save time to general practitioners (GP).~      The main aim of this study is to test non-inferiority of a web based BI for risky drinkers~     against a traditional face to face BI delivered by a general practitioner. We have designed~     a randomised controlled non-inferiority trial comparing both interventions, to be performed~     in primary care health centres in Catalonia, Spain.~      Adults attending in primary care centres and willing to participate, will be invited to fill~     the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those~     screening positive and who accept to share the baseline data with their GP will be invited~     to an online assessment of their drinking and randomized to a standard BI with their GP or~     to the online BI.~      Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use~     Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The~     main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30%~     reduction in the proportion of risky drinkers in the control group (classroom), allowing for~     an overall attrition of 10% of patients in the trial and non-inferiority assessed against a~     specified margin of 10%, it is estimated that 500 patients would be required in each group~     to give the test a 90% power (1-β) to reject the null hypothesis.~   "
74439|NCT02082977|"~     This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose~     (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be~     conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL),~     transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors and~     multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion~     cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D~     in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal~     centre B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.~   "
74440|NCT02082964|"~     In this randomized controlled trial 48 students were randomly allocated in three groups~     SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP~     and lasted 6 hours for each group. Before and after the workshops and one month later all~     students participated in a 7 station OSCE..~   "
74441|NCT02082951|"~     The objective was to compare the frequency and intensity of symptoms of anxiety in patients~     of preoperative cardiac surgery who received empathic behaviour from nurse or family or~     those who received no specific type of empathic behaviour. This is a randomized clinical~     trial. The sample consisted of 66 patients in preoperative of cardiac surgery, who were~     divided in three groups: empathic behaviour by nurses, without specific empathic behaviour~     and by family. Anxiety was assessed at two time points: before and after the intervention.~     The instrument used was developed and validated, comprising 19 defining characteristics of~     the nursing diagnosis anxiety. The hypothesis is that the group who received empathic~     behaviour from nurse or family will reduce the anxiety.~   "
74442|NCT02082938|"~     The purpose of this study is to verify if the incorporation of a new brace, which assists in~     gait rehabilitation, can contribute to the rehabilitation process for stroke patients.~   "
74443|NCT02082925|"~     In view of the multiple limitations and restrictions relative to CPET (technical, time,~     physical…), determination of individualized training threshold from this evaluation is today~     not possible for a lot of patients.~      The aim of this study was to propose a new clinical tool from 6MWT for individualized~     exercise training: the dyspnea threshold (DT6).~   "
74444|NCT02082912|"~     The purpose of this study is to focus on enhancing upper limb recovery in patients~     post-stroke by using robotic-assisted therapy in combination with a drug to improve learning~     new motor skills.~   "
74445|NCT02082899|"~     This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel,~     Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment~     of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC)~     Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects~     will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.~   "
74446|NCT02082886|"~     In this registry study the investigators will collect data about patients' disease,~     treatment, and response to treatment to include in both our local and national databases.~     These can then be used by investigators to answer questions about cytoreductive~     surgery/HIPEC such as how well-tolerated or effective it is in specific populations.~   "
74447|NCT02082873|"~     This research is being conducted to determine if Neuroscience intensive care unit (ICU)~     nurses are able to identify seizures by reviewing quantitative EEG (qEEG) that is running at~     the bedside. QEEG is the application of mathematical and analytical techniques to analyze~     EEG signals. Several hours of data can be displayed on a single screen in several graphical~     panels. Routine evaluation of EEG data consists of manual inspection of each page of EEG~     data by a trained neurophysiologist (a neuro ICU doctor) and can be quite time-consuming. In~     most cases, this data can only be reviewed intermittently and interpretation is almost~     always relayed to the primary clinical team after the seizures have occurred.~     Theoretically,qEEG graphical displays can provide a simplified view of complex EEG data that~     could possibly be used by non-neurophysiologists, such as Neuro ICU nurses. Our hypothesis~     is that Neuro ICU nurses are able to accurately identify recurrent seizures in real-time.~   "
74448|NCT02082860|"~     This is a Phase I trial aimed to determine the safety of the investigational gene therapy~     product (rAAV2/5-PBGD) for the treatment of Acute Intermittent Porphyria (AIP).~      Up to eight patients fulfilling the eligibility criteria will participate in this~     multicentre, open label, single dose, dose-ranging Phase I clinical trial.~      The enrolled patients will be followed up to assess the safety profile of the~     investigational gene therapy product and to establish the maximum therapeutic safe dose to~     be administered in future confirmatory/pivotal clinical trial(s). In addition, the~     biological and clinical response to the treatment with rAAV2/5-PBGD in AIP patients will be~     assessed.~      A complete evaluation of the clinical (symptoms and quality of life assessment) and~     laboratory (blood and urine) data will be performed.~   "
74451|NCT02082808|"~     This study is designed to estimate the two-way drug interaction between DCV and DTG as a~     drug interaction between DTG and DCV is expected to be low and this study is to be performed~     as confirmation. This will be a single-center, open-label, three-period, crossover study in~     healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV~     pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h~     and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the~     safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV~     60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h~   "
74452|NCT02082795|"~     The investigators aim to perform a qualitative study to explore the views of women with a~     breech presentation on their management in general, and the use of anaesthesia or analgesia~     for ECV in particular.~   "
74453|NCT02082782|"~     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method~     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near~     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are~     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the~     cell membranes, and create 'nanopores', after which the cell dies through loss of~     homeastasis.~      The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the~     treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for~     resection or thermal ablation due to vicinity to vulnerable structures such as vessels and~     bile ducts. Other objectives are safety, feasibility (technical success) and imaging~     characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities~     in dianosing local site recurrence (LSR) or residual disease (RD).~      29 patients with histologically confirmed colorectal carcinoma who present with unresectable~     and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open~     irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious)~     adverse events are registered. One day post-IRE MRI is performed to assess technical~     success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize~     residual or recurrent disease. Overall technique effectiveness is determined 1 year after~     treatment.~      The investigators hypothesize that IRE for central CRLM will lead to good tumor control~     without causing severe complications.~   "
74454|NCT02082769|"~     The purpose of this study is to compare febuxostat allopurinol in subjects with gout.~   "
74455|NCT02082756|"~     The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine~     Hydrochloride on lowering glucose and delaying progress to diabetes in patients with~     prediabetes and to detect the potential mechanism.~   "
74456|NCT02082743|"~     The purpose of this study is making use of school policy- recess outside classroom (ROC7-11)~     for increasing the time spent outdoor during recess and encouraging children spent time~     outdoor up to 11 hours in each week to investigate the vision change, myopia onset and~     progression in these schoolchildren.~   "
74457|NCT02082730|"~     This study aims to improve on the delivery of treatment for people with Chronic Fatigue~     Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This~     interferes with doing everyday activities and has a major impact on quality of life. Energy~     management is a key aspect of treatment and involves patients building up their energy~     levels gradually. Their health professional finds out how much energy the patient uses daily~     so they can prescribe how much activity and rest is right for the patient. The prescription~     is adjusted throughout treatment. Over time, the patient learns the best way to spend and~     preserve energy. To begin treatment, patients record their activity levels on paper over a~     few weeks. Records need to be accurate, but this is often difficult because of problems with~     memory, concentration or low energy and pain.~      We have recently developed a new technology called ASARM (Advanced Sleep Rest Activity and~     Rest Management) that records activity levels electronically and checks whether they match~     the activity prescription. The ASARM device is worn on the patient's wrist. It measures~     sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily~     activities. The health professional has remote access to the information and uses the app to~     change the prescription. This study will investigate if ASARM is (i) acceptable to patients;~     (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to~     improve their symptoms. Patients and clinicians will gain experience of ASARM for a short~     time, and we will analyse their data. Our findings will help us develop ASARM so that it can~     be used in routine care of CFS/ME patients.~   "
74458|NCT02082717|"~     The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during~     peripheral intravenous potassium chloride replacement therapy for adult patients in a~     Medical/Surgical unit. Using a randomized controlled double blinded experimental study~     design, patients who are 21 years or older are alert, awake, and oriented at the time of~     enrollment and have been ordered peripheral intravenous potassium chloride replacement will~     be recruited from one Medical/Surgical during the first 24-48 hours of their admission.~   "
74459|NCT02082704|"~     Investigators are conducting a randomized controlled trial to determine whether an online~     team-based spaced education (SE) game can improve HbA1c levels among these patients with~     diabetes (primary aim). Secondary aims include determining the impact of the game on~     patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine~     (M/C) ratio, ACE PPR, and ARB PPR.~   "
74460|NCT02082691|"~     Patient with advanced liver cancer (cancer that has spread to other parts of the body)~     continues to receive the study drug (G-202) even though patient no longer meets the criteria~     to be a part of the main treatment study. Patient's cancer responded well to receiving G-202~     in the main study and will receive G-202 at the same dose given in the main study.~   "
74461|NCT02082678|"~     The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated~     with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD).~     The investigators will also use blood samples to determine if the genotype for the serotonin~     transporter gene is associated with response to ondansetron.~   "
74836|NCT02077777|"~     The purpose of this study is to obtain an in vivo confirmation that mesalazine induces the~     gene expression of μ-protocadherin and other related genes in the colon mucosa, as~     demonstrated in some in vitro experiments. .~   "
74837|NCT02077764|"~     Objective:~        -  To assess the relationship between coronary allograft vasculopathy (CAV) and graft~          function, and to evaluate non-invasive methods for CAV diagnosis.~        -  To assess left ventricular (LV) and right ventricular (RV) function in the acute phase~          and serially during the first year after transplantation.~        -  To evaluate the impact of acute and repetitive rejection on the longitudinal myocardial~          function Hypothesis~             1. Timing of development and degree of CAV can be measured non-invasively combining~               myocardial longitudinal deformation (by advanced echocardiography) and coronary~               flow velocity reserve (CFVR) (by echocardiography and PET). This combination of~               methods can detect CAV before it is angiographically visual and gives~               supplementary information of the impact on myocardial graft function.~             2. Longitudinal deformation, 3D echocardiography, cardiac magnetic resonance imaging~               (CMRI) and PET can be used for RV and LV myocardial function assessment and~               represent more valid markers of the function than standard echocardiography in~               heart transplant (HTX) patients.~             3. Myocardial longitudinal deformation is a better marker of acute rejections than~               conventional ejection fraction (EF).~      Background The most frequent heart related death causes after HTX are CAV, acute graft~     failure and rejection.~      CAV is characterized by diffuse concentric intima thickening involving both epicardial~     vessels and the coronary microvascular system. In our clinical approach HTX-patients are~     followed with annual CAG and standard echocardiography with estimation of LV systolic~     function by EF. Standard echocardiography has not proven benefit in the diagnosis of CAV.~     CAG often misses CAV in early phases.~      In various cardiac diseases it is well known that ischemia and fibrosis often affect the~     endocardial longitudinal oriented layers. Longitudinal deformation by advanced~     echocardiography has shown to be better markers for systolic function in HTX patients~     compared to standard EF. Longitudinal LV systolic function is dependent of endocardial~     perfusion. CFVR represents the capacity of the coronary circulation to dilate due to~     metabolic demands and has been shown to correlate with longitudinal deformation in~     myocardial infarction. CFVR measurements in HTX patients with advanced echocardiography and~     PET scan have shown a significant correlation to CAV.~      RV failure is an early, potentially fatal, complication to HTX. The function and change over~     time of RV have not been fully studied using modern echocardiographic techniques or~     assessment by CMRI.~      Acute rejection is an inflammatory response often diagnosed by routine biopsies (gold~     standard). These are expensive, time consuming and inconvenient for the patient. The role of~     conventional echocardiography has not yet found a significant role in the diagnostics of~     acute rejections and furthermore how repeated rejections influence on graft function is not~     well described.~      Study 1 A cross sectional study consisting of 50 stabile HTX patients. These will be~     selected with 25 patients with no or light CAV and 25 patients with moderate or severe CAV.~      Severity of CAV will be evaluated by:~        -  CAG~        -  CFVR measurement by advanced echocardiography and PET.~      Graft function will be evaluated by:~        -  Advanced echocardiography at rest end during bicycle exercise.~        -  CMRI including assessment of LV and RV EF, strain and mass.~        -  During rest and bicycle exercise echocardiography simultaneously right heart~          catheterization are performed for hemodynamic measurement~      Study 2 A prospective cohort study with 20-25 newly transplanted patients over a period of~     12 months.~      LV and RV function will be measured by:~        -  Advanced echocardiography~        -  CFVR measurement (echocardiography and PET)~        -  CMRI for LV and RV EF, strain and mass~        -  Right heart catheterization~      Study 3 Prospective examination of correlation between graft function, CAV and rejection.~     Information of former episodes of acute rejection is collected retrospective. Study~     objectives are all living HTX patients (approx. 200) in the period of 2011-2013.~      Advanced echocardiography (including longitudinal deformation), biopsies (rejection~     evaluation) and CAG (CAV evaluation).~   "
74462|NCT02082665|"~     This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600~     mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of~     rosuvastatin and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose~     of dabrafenib 150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily [BID]).~     Dabrafenib 150 mg BID will be administered from Day 8 to Day 23. Blood samples for PK~     analysis will be obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose~     of dabrafenib will be taken in the morning of Day 23 and the last blood sample in the~     evening of Day 23. Subjects will be considered to have completed the study once the 32 hour~     PK sample has been collected on Day 23. Once they have completed the study, eligible~     subjects may have the option to enter study BRF114144, an open-label roll-over study of~     dabrafenib (no follow-up visit required) and continue receiving dabrafenib.~   "
74463|NCT02082652|"~     Antiretroviral therapy (medicines used to treat HIV) can interact with hormonal~     contraceptives which might decrease their effectiveness. The single-rod etonogestrel~     contraceptive implant is being more commonly used in low- and middle-income countries~     because if the ease of insertion and removal. Efavirenz and nevirapine are first-line HIV~     medicines in Sub-Saharan Africa and this study will help determine an effective way to use~     these medicines with the etonogestrel implant. The investigators hypothesize that women~     receiving nevirapine- or efavirenz-based antiretroviral therapy will have lower etonogestrel~     levels in their blood after six months of insertion as compared to women not taking~     antiretroviral therapy.~   "
74464|NCT02082639|"~     The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK~     Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV~     vaccine according to 0, 6 month schedule, compared to the administration of either of these~     vaccines alone. The study will ascertain that the immune responses elicited to the two~     vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV~     vaccine are administered alone.~   "
74465|NCT02082626|"~     This is a study for children with cancer with no curative treatment options. The~     investigators will be giving eribulin, a new chemotherapy agent, for the first time to~     children. This study is designed to determine a safe dose the investigators can give to~     children in larger studies. The investigators will be monitoring the children on this study~     for the safety of the treatment and levels of eribulin in the blood after treatment. The~     investigators will also study the effect of the agent on the cancer.~   "
74466|NCT02082613|"~     This study will compare a minimal invasive operation in local anesthesia with sclerotherapy~     for symptomatic testicular hydrocele within 6 months after randomization. Thirty days~     complication rates will be assessed. The hypothesis is that surgery will lead to faster cure~     while sclerotherapy would be cheaper and have less complications.~   "
74467|NCT02082600|"~     The aims of this study are examine the effects of sleep deprivation in muscle recovery after~     a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24~     series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy,~     aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in~     which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to~     normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same~     exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep~     rebound.~   "
74468|NCT02082587|"~     As treatments improve and patients live longer with cancer, even after it has spread to the~     brain, efforts to improve quality of life are growing. Neurocognitive function (thinking~     ability and memory) is an area of particular concern for patients with brain metastases~     (cancer that can spread to the brain). Although there are established tests to measure~     neurocognitive function, these require a face-to-face assessment and can take a long time to~     complete. As a result, efforts to use these tests to measure changes in neurocognitive~     function in patients following treatment for brain metastases have resulted in a large~     proportion of patients who do not return for follow-up. This has limited the ability to~     evaluate the impact of current treatments on neurocognitive function. This study aims to~     evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it~     easier for patients to complete these tests in follow-up. If this new tool is found to~     reliably measure neurocognitive function, it could be used for future studies evaluating new~     interventions that prevent or treat neurocognitive deterioration following treatment of~     brain metastases. This is the first prospective study to evaluate the feasibility and~     reliability of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB)~     compared with the same battery delivered face-to-face in this population. The investigators~     hypothesize that telephone administration of this brief neurocognitive battery will reliably~     evaluate neurocognitive function and improve patient ability to complete follow-up~     assessments.~   "
74469|NCT02082574|"~     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability~     in the general population, secondary to the accumulation of asymptomatic elementary lesions.~     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be~     challenging in term of public health care in the future. While HIV patients share the same~     cardiovascular risk factors and they are often diagnosed with cognitive impairment and~     frailty, CSVD has not been yet described in this population.~      The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population~     compared to HIV- controls matched with age and sex.~      500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the~     CSVD with a 10 minutes MRI (FLAIR and T2*).~      Prevalence of the CSVD will be compared between HIV+ patients and controls. General and~     HIV-specific parameters from their electronic medical records will be compared between~     HIV+/CSVD+ and HIV+/CSVD- patients.~      We are expecting to prove that CSVD is more frequent in HIV+ population.~   "
74470|NCT02082561|"~     The aim of the current study was to test the efficacy of an individually administered, brief~     (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called~     F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive~     strategies (so-called safety aids) among individuals suffering from a range of anxiety~     disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and~     panic disorder (PD). We hypothesized that the F-SET protocol would produce better overall~     outcome relative to a waitlist control.~   "
74471|NCT02082548|"~     To determine whether a comprehensive evaluation and customized multilevel educational~     interventions will increase the rate of use of oral anticoagulants and the adherence and~     persistence of use in patients with atrial fibrillation. Our hypothesis is that there will~     be differences in the use of oral anticoagulants and the persistence in patients between the~     control and interventional group. There will be a greater change in the use of oral~     anticoagulants over one year in the cohort in the intervention sites than the control sites.~     This will be due to two factors: greater initiation of oral anticoagulants among patients~     not treated at baseline and greater persistence of treatment for those on treatment at~     baseline~   "
74472|NCT02082535|"~     The improvement of treatment of preterm neonates improved their survival, however there is~     still significant portion of preterm infants (specifically very preterm infants) that~     suffers from brain insults and as a result developmental deficits. The brain injury is a~     consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and~     metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage~     and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury~     is still abundant. Several treatments has been suggested and tested in animal models to~     prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and~     different types of stem cells. However, two main obstacles prevent the use of these~     medication, first the uncertainty of their effect on the developing brain and second the~     difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and~     clinical signs are used to time and grade the brain injury, in preterm infants there is no~     real time tool to indicate severity and timing of brain injury. The disability point out a~     beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in~     preterm infants. The aim of this study is to try and delineate such therapeutic window by~     using brain injury biomarkers.~      S100b and GFAP are well recognized biomarkers of brain injury in adults, children and~     infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly)~     will be sampled. A database of the clinical status of the infants will be collected, as well~     as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18~     months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their~     timing will be correlated with the severity of the clinical status, Two the duration of~     increased level of S100b and GFAP will be associated with abnormal MRI at term findings and~     abnormal developmental assessment.~   "
74473|NCT02082522|"~     Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is~     activated by a light from a laser that emits no heat. This technique works to allow the~     medical doctor to specifically target and destroy abnormal or cancer cells while limiting~     damage to surrounding healthy tissue. The activation of the drug is done by lighting the~     abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits~     light transmission) inserted into a flexible tube with a light called cholangioscope for the~     bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue,~     leading to its destruction.~      This research study will evaluate the efficacy and safety of PDT with porfimer sodium~     administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival~     time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile~     ducts. It will involve 200 patients across North America and Europe. Other countries may~     participate if needed. Participation will last at least 18 months.~   "
74474|NCT02082509|"~     One of the most common symptoms suffered by traumatic brain injury (TBI) patients is~     disruption in attention. Lack of attention impacts daily life including academic or~     professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for~     Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to~     investigate the changes in neurological function with special interest in attention after~     TBI for children ages 8 to 16. This study will be done through advanced neuroimaging~     procedures, neurocognitive testing, and an online training tool created by The Brain~     Plasticity Institute. The investigators hypothesize that the training will improve attention~     in TBI subjects and that the advanced imaging will show corresponding neural connectivity~     changes, as compared to matched healthy controls.~   "
74475|NCT02082496|"~     The obesity epidemic is attributable to dietary and behavioral trends acting on a person's~     genetic makeup to determine body mass and susceptibility to obesity-related diseases. Common~     forms of obesity have a strong hereditary component and many genetic pathways that~     contribute to obesity have already ben identified.~      Glucagon-like peptide (GLP) -1 is an incretin hormone that potentiates glucose-stimulated~     insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the~     appetite center in the hypothalamus. Today, GLP-1 agonists are available for treatment of~     type 2 diabetes, and their treatment potential in obesity is an area of active research.~      The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in~     people diagnosed with obesity causing genetic disorders and to investigate the physiological~     role of GLP-1 on food intake and appetite regulation in this group.~   "
74476|NCT02082483|"~     Kidney transplant candidates are at very high risk for coronary artery disease (CAD). The~     optimal strategy to monitor and maintain the cardiac fitness of patients awaiting kidney~     transplantation is unknown. Currently patients undergo annual testing; however, screening~     for CAD may increase morbidity and mortality by:~        1. exposing patients to the risk of angiography and revascularization procedures~        2. delaying or excluding patients from life saving transplantation.~      Before proceeding with a definitive study to determine whether screening is necessary,~     feasibility will be determined in this pilot study.~   "
74477|NCT02082470|"~     This pilot clinical trial studies survivorship care planning in supporting quality of life~     in ovarian cancer survivors following primary treatment. Survivorship care plans have the~     potential to empower patients and provide them with a plan of care following treatments.~     Survivorship care planning may support patient's overall well-being and quality of life~     after treatment of ovarian cancer.~   "
74478|NCT02082457|"~     This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable~     Bowel Syndrome With Constipation. The difference of responder rate between test group (10,~     20 and 40mg) and placebo will be evaluated.~   "
74479|NCT02082444|"~     Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically~     proven insights into cognitive effects of lunch to the existing recommendations for school~     meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an~     enhancement of CogniDo this study investigates the short-term effects of having school lunch~     versus skipping it on children's executive cognitive functions in the afternoon. The study~     was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215~     children.~   "
74480|NCT02082431|"~     The purpose of this study is to determine the true incidence of long QT (LQT) amongst a~     large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural~     hearing loss.~   "
74481|NCT02082418|"~     Aging modifies the metabolic pathway of the neurotransmitter serotonin by reducing the~     synthesis rate and increasing the breakdown rate of serotonin, possibly related to the~     observed enhanced sensitivity of the serotonergic pathway. Since serotonin plays a prominent~     role in neuropsychological functions such as anxiety, mood and memory, the enhanced~     sensitivity of the serotonergic pathway in aging can probably explain the fact that elderly~     are more vulnerable to develop cognitive deficits and depressive symptoms.~      Serotonin synthesis in brain is regulated by its precursor tryptophan (TRP). Because~     tryptophan is an essential amino acid, modifying the availability of tryptophan through~     dietary intake, can directly influence central serotonin metabolism and consequently~     affective and cognitive processes.~      The aim of this study is to test the hypothesis that an acute intake of whey protein with~     high levels of TRP such as alpha-lactalbumin can stabilize the metabolism of serotonin and~     subsequently enhance metabolic and cognitive functions in healthy older adults. The acute~     effects of this dietary protein will be investigated in subjects with mild cognitive~     impairment (MCI), or dementia, compared to control subjects in order to examine whether~     healthy older subject with MCI benefit more from the intake of alpha-lactalbumin and/or~     whey. The investigators will investigate if this meal can optimize serotonin metabolism by~     elevating plasma TRP levels and plasma TRP appearance and enhance splanchnic TRP extraction.~     In addition, the effects on mood and cognitive functions will be examined.~   "
74482|NCT02082405|"~     This phase II trial studies the side effects and how well lower doses of bortezomib,~     dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving cyclophosphamide daily may kill more cancer cells.~     Giving bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for~     multiple myeloma.~   "
74483|NCT02082392|"~     The goal of this study is to develop new methods of administering antidepressant medications~     that will result in improved drug/placebo separation in randomized controlled trials (RCTs)~     for Major Depressive Disorder (MDD) and enhanced medication response in open clinical~     treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs~     radically differs from how antidepressant medications are prescribed in standard clinical~     practice and is believed to be a major reason why the majority of studies submitted to the~     Food and Drug Administration (FDA) fail to show a significant difference between medication~     and placebo. Moreover, a one size fits all approach to psychopharmacologic management~     (i.e., weekly visits for all patients) does not take into account differences between~     patients that may predispose some individuals to respond positively to frequent follow-up~     visits, while others may respond negatively or not at all. Clinic visits comprise multiple~     components that may be therapeutic for depression, including activating patients' behavior,~     exposing them to medical procedures, permitting social interactions with research staff, and~     providing supportive meetings with clinicians. Two independent meta-analyses have associated~     more frequent study visits with increased antidepressant and placebo response as well as~     decreased separation between medication and placebo. Despite the high costs and potential~     disadvantages of weekly follow-up visits for patients receiving antidepressant medication,~     this clinical management strategy has not been studied prospectively to date. It is unknown~     whether weekly follow-up visits are needed to ensure treatment compliance and patient safety~     in clinical trials and to what degree contacts with clinicians influence medication and~     placebo response.~   "
74484|NCT02082379|"~     We hypothesize that infant and children will show different levels of acceptance of~     different interfaces while they receive inhaled therapy.~      We also hypothesize that children will exhibit different amounts of time with the aerosol~     well aligned with the nostrils during transnasal aerosol delivery.~   "
74485|NCT02082366|"~     The aim of the investigators study is to analyze the incidence of MES by TCD performed~     during AF ablation with the nMARQ and to compare is with the incidence of MES using a~     conventional irrigated ablation catheter. Objective: To investigate the incidence of MES on~     TCD during AF ablation with the nMARQ catheter compared to a conventional irrigated ablation~     catheter. Following inclusion, patients will be randomized into 2 equal different treatment~     groups: PVI with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In~     all patients, anticoagulation therapy with warfarin is discontinued five-days before the~     procedure and low molecular weight heparin is initiated at that time. A CT-scan of the left~     atrium is performed and imported into the Carto 3 mapping system. The ablation procedure is~     conducted under general anesthesia or conscious sedation. A decapolar catheter is positioned~     in the coronary sinus and a quadripolar catheter is positioned at the His bundle level~     through the right femoral vein. Two 8F sheaths are introduced into the left atrium with~     double trans-septal puncture performed under fluoroscopic, trans-esophageal~     echocardiographic or intracardiac echocardiography guidance. Upon completion of the first~     trans-septal puncture, intravenous heparin is administered to maintain an activated clotting~     time of 350 seconds throughout the procedure. A variable Lasso circular mapping catheter is~     introduced through the SL1 sheath into each pulmonary vein for electrical mapping. After the~     second trans-septal puncture, a Navistar Thermocool 3.5mm irrigated ablation catheter or an~     nMARQ circular irrigated ablation catheter are introduced into the left atrium. Of note, in~     case of use the nMARQ catheter, the second SL-1 sheath is replaced by a steerable 8F agilis~     sheath after the second trans-septal puncture. Each of the 4 PVs are imaged by selective~     angiograms. The left atrium geometry is created using the nMARQ catheter or the Navistar~     catheter and then merged with the pre-acquired CT scan of the left atrium and PVs.~     Identiﬁcation of true MESs will be possible using an event detector system, in addition to~     determining whether the MESs are attributed to a solid or to a gaseous embolus. Total MES~     counts will be collected and evaluated separately during different stages of the procedure.~   "
74486|NCT02082353|"~     Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone~     marrow transplantation has been shown to be curative. However the risks of transplantation~     are high and not all patients with CGD may need to undergo this high risk procedure. This~     study will determine the long term medical condition and daily functioning of patients with~     CGD after a transplant and if possible, compare these results to patients who do not undergo~     a transplant.~   "
74487|NCT02082340|"~     Randomized trial tests effectiveness of self-administered drug intake by empowered TB~     patients - supervised by a trained family member and supported by medical counseling and~     reminders - to improve treatment adherence and treatment success rates, and thereby~     forestall TB and MDR-TB epidemics.~   "
74488|NCT02082327|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as~     compared to IV administered migalastat HCl in healthy volunteers. The data from this study~     will help us understand how migalastat works in the body and will help us determine what~     would be an effective dose in future studies with migalastat hydrochloride.~   "
74489|NCT02082314|"~     Bone metastases are a cause of significant morbidity in cancer patients. In patients who die~     from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have~     evidence of bone metastases at the time of death (1). These metastases frequently give rise~     to complications that reduce patients' quality of life. These include: pain, fractures, and~     decreased mobility, ultimately reducing performance status.~      Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone~     metastases has been shown to be feasible, efficacious, and safe. However, patient reported~     outcomes have yet to be determined.~   "
74490|NCT02082301|"~     This is an observation study of women with gestational diabetes. Subjects recruited undergo~     immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt~     diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an~     immediate post partum screen for overt diabetes compared to a traditional 6 week test.~   "
74491|NCT02082288|"~     Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI)~     according to EIOS~   "
74492|NCT02082275|"~     The study defines a new model of prenatal care called OB Nest which will be compared to the~     traditional model of prenatal care. OB nest is intended to create an experience for patients~     that feels more connected and patient-centered, allowing the patient to visit the clinic~     less frequently while offering increased communication with the OB nurses and providers~     through new tools provided to the patient. The goal of the project is to promote~     patient-centered care through a new prenatal care program based on constant and direct~     support from a nursing team, meeting the on-demand needs of expecting mothers as they rise,~     and as thus, redesigning the need and timing of on-site appointment with providers. Pregnant~     women randomized to the OB Nest cohort will see the number of pre-planned visits with their~     providers decreased and replaced with more direct and constant support and interaction with~     an assigned nursing team.~   "
74493|NCT02082262|"~     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal~     or perennial allergic conjunctivitis.~   "
74494|NCT02082249|"~     This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187~     in subjects with advanced Parkinson's disease.~   "
74495|NCT02082236|"~     The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK)~     of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and~     compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg~     administered 20 minutes apart.~   "
74496|NCT02082223|"~     A pilot to test feasibility of improving patient/caretaker quality of life and resilience.~   "
74497|NCT02082210|"~     The purpose of this study is to find a recommended schedule and dose range for LY2875358~     when given with ramucirumab that may be safely given to participants with cancer. In Part A~     of this study, escalating doses of LY2875358 will be given in combination with a fixed dose~     of ramucirumab to evaluate the safety of the combination. After a recommended schedule and~     dose range of LY2875358 and ramucirumab has been established, Part B of the study will~     confirm safety and to see how well certain tumors respond to the combination of study drugs.~     The average amount of time on study is expected to be about 6 months.~   "
74498|NCT02082197|"~     This is an open-study with a 26 week open label treatment period followed by an optional 26~     week open label extension. The total treatment period will be 52 weeks.~   "
74499|NCT02082184|"~     To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic~     control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised~     controlled study design in adults with Type 2 diabetes using insulin.~   "
74500|NCT02082171|"~     Prevention of physical disability represents a major priority for the public health system.~     Physical disability is the final result of a complex cascade of negative events occurring at~     different levels (i.e., environmental, social, biological, and clinical). The heterogeneity~     of the underlying mechanisms responsible for the onset of physical disability may require~     the adoption of preventive interventions affecting multiple domains. Although several~     studies suggest that single or different combinations of preventive interventions (in~     particular, physical activity, cognitive training, and healthy diet) might provide~     beneficial effects in preventing functional loss (and its related features, such as pain or~     reduced quality of life), very limited evidence coming from clinical trials is currently~     available on the topic. Intervention trials are usually designed to test the effect of a~     specific monodimensional intervention on a very selected population, so to reduce the risk~     of biased results. This approach, although legitimate and methodologically correct, may 1)~     be insufficient to target the multiple and heterogeneous physiopathological mechanisms~     underlying the onset of physical disability, and 2) cause a population selection bias~     leading to difficulties in implementing the study results to the overall older population~     (thus, determining the evidence-based medicine issue in the elderly). To our knowledge,~     there are no available data from clinical trials evaluating the effects of a multidomain~     intervention based on lifestyle modifications (e.g., physical activity, cognitive training,~     nutritional modification) for preventing mobility disability (a very early phase of the~     disabling process) in community-dwelling older persons. In the present project (Multidomain~     Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study~     aimed at estimating the effects of a multidomain person-tailored preventive intervention~     (based on physical activity, cognitive training, and nutritional modifications) on frailty~     status, physical performance, cognitive function, nutritional status, health-related quality~     of life, and use of health care services. In addition, we will perform cost-effectiveness~     analyses of the proposed intervention. The project will yield the necessary preliminary data~     to design a definitive full-scale Phase 3 randomized clinical trial. By providing a~     conclusive answer about the effectiveness of a multidimensional preventive program in the~     primary prevention of major health-related outcomes, the results of the full-scale trial~     will have relevant clinical and public health implications, and will promote the practicing~     of a truly evidence-based geriatric medicine.~   "
74501|NCT02082158|"~     This VA-based study will obtain feedback from healthcare workers via validated survey~     instrument on the comfort and tolerability of wearing current models of N95 respirators and~     novel respirator designs currently in development. There will be 4 novel respirators and 1~     commonly used respirator (not locally used) to compare to a locally used respirator, which~     is familiar to participants. Comparisons will be examined between each of the first 5 models~     with the locally used control using Dunnett's t-test.~   "
74502|NCT02082145|"~     To assess the effect of the device on the progression of diabetic peripheral neuropathy~   "
74503|NCT02082132|"~     The purpose of this study is to describe and compare the different types of diabetes that~     exist in people from white European and south Asian origin in the UK (United Kingdom) who~     are diagnosed with diabetes before they turn 30 years old. By doing this we hope to identify~     cases of MODY (maturity onset diabetes of the young), which is a rare genetic cause of~     diabetes that is frequently misdiagnosed. Identifying MODY cases is important, as the~     treatment may differ to conventional treatment for type 1 or type 2 diabetes.~   "
75770|NCT02065531|"~     The purpose of the current randomized clinical trial was to compare the effectiveness of~     myofascial soft tissue release versus mobilization with impulse technique torsion (anterior)~     on pain, disability, and kinesiophobia in individuals with chronic non-specific low back~     pain.~   "
74505|NCT02082106|"~     Problem description In industrialized countries there is a rapid increase in the number of~     senior citizens. In Austria more than 50% of the population is overweight, with highest~     prevalence in the age group from 60 to 74 yrs and the WHO lists physical inactivity as one~     of the main behavioral risk factors of cardiovascular diseases.~      Especially in winter months, activity related energy expenditure was 40% and 31% lower in~     the US and Canada, respectively. In addition, in an Austrian study the winter season was~     associated with higher blood pressure, total cholesterol and body mass index, giving an~     increasing risk of chronic coronary disease by 6.8% in men and 3.6% in women.~      Therefore, the development of intervention programs that overcome the winter physical~     activity deficit and be feasible also for elderly should be goal of future research. Alpine~     skiing (AS) and cross country skiing (XCS) have a long standing tradition in Austria and~     could potentially fill the winter physical activity gap. The Salzburg Skiing for the Elderly~     Study (SASES) has found AS to be a save and feasible possibility to improve the health of~     the aged population in many parameters. XCS as a competitive sport is already well explored~     but there are hardly any studies about its effects in the normal or elderly population.~     Unfortunately knowledge about the differences between AS and XCS in the physiological~     adaptation processes in the elderly population is also lacking.~      Aims and hypotheses of the pre-study In order to standardize training interventions, the~     present pre-study aims at comparing physiological and metabolic parameters between AS, XCS~     and IT. Therefore, the results of the pre-study serve as determinants for the training~     parameters of the above mentioned main study.~      We postulate that, based on the results of the present study, it is possible to set up~     comparable isocaloric training sessions for AS, XCS and IT for elderly and unfit persons.~      Furthermore, we assume that elderly and unfit subjects are able to perform a full spectrum~     of intensities and techniques necessary to set appropriate stimuli for isocaloric~     comparison.~      We hypothesize arterial stiffness indices and circulating microRNA (miRNA) patterns to~     change due to one bout of physical activity of AS, XCS, and IT with variations depending on~     the kind of sport.~   "
74506|NCT02082093|"~     The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of~     a telemedicine system : eNephro Application , compared with traditional care in the~     management of chronic renal failure in different populations :~        -  population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of~          target blood pressure and proteinuria .~        -  population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative~          duration of hospitalization in short-stay for 1 year.~        -  population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative~          duration of unplanned short stay for 1 year.~      The intervention tested in this study is a telemedicine system which is a collaborative and~     expert system, consisting of:~        -  A dynamic shared medical record for the collection of administrative , medical,~          biological and clinical data for each patient. All health professionals can access the~          folder and fill in the support. It is the same for patients treated at home.~        -  A secure messaging for communication between health professionals and between patients~          and health professionals~        -  Expert systems analyzing data from each patient~        -  A management tool of therapeutic education~        -  A compliance assistance: electronic pillbox and pharmaceutical care Patients included~          in this study are major patients, male and female who signed a consent form. These~          patients have a chronic renal failure moderate to end up being treated by ambulatory~          dialysis or kidney transplantation. The patients of each population will be randomly~          assigned in group 1 ie traditional care or in group 2 ie traditional care added by~          telemedicine system.~      Each patient and whatever the group will perform as part of its monitoring of the CKD~     assessments at baseline , 6 months and end of study (12 months). These evaluations are about~     compliance, quality of life, anxiety - depression state. To enhance costs the point of view~     retained will be health insurance's point of view. Among the various costs, only direct~     costs are considered: disease management, hospitalizations, consultations in hospitals and~     private practice, prescribed medical transportation , home visits by health professionals,~     additional assessments related to the evaluated intervention. A probabilistic matching with~     the data bases of the National Information System of the Social Insurance will be performed.~     In addition, the acceptability of the system of telemedicine by patients in the intervention~     and health professionals will be also evaluated.~   "
74507|NCT02082080|"~     This study evaluates the effect of an interventional model for preventing and controlling~     overweight and obesity in male and female fifth-graders. First, based on WHO (World Health~     Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students~     from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be~     screened. Then from the screened students 30 students with the following inclusion criteria~     will be recruited: not metabolically ill, not on a weight losing diet and not professionally~     athlete. For selected students BMI-Z score as primary outcome will be calculated.~     Demographic data, as well as data on waist and hip circumference, triceps skin-fold~     thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity~     will be collected at the beginning and at end of the 6-month intervention. The approach of~     the study will be Health Promoting Schools. The intervention includes three components,~     i.e., nutrition education (students and parents), increased physical activity, and changing~     environment (food items offered in schools' canteens). Nutrition education will be imparted~     (a 30-minute session per week) by health instructors; physical activity will be done under~     the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a~     1.5-hour session) will be monthly. Finally the efficacy of the intervention will be~     determined and reported.~   "
74508|NCT02082067|"~     Aim of this study is to evaluate the effects of the adductor canal block on the early and~     medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used~     in the knee prosthesis.~   "
74509|NCT02082054|"~     This active vs active comparative trial will evaluate the safety and efficacy of incremental~     doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult~     patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal~     symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by~     statistical significance where p < 0.05.~   "
74510|NCT02082041|"~     The purpose of this study is to monitor the skin blood flow in the lower leg, with different~     levels and types of applied loads. These loads will not be placed over the patient's wound~     nor will they be higher than loads the skin normally experiences in daily activities. The~     results of this research will help investigators understand the development of pressure~     ulcers, commonly known as bedsores and stasis ulcers.~   "
74511|NCT02082028|"~     To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the~     Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control~     at 12 months in patients with type 2 diabetes not treated with insulin.~   "
74512|NCT02082015|"~     The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper~     Extremity Motor Function Recovery in Patients with Ischemic Stroke~   "
74513|NCT02082002|"~     Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not~     completely understood. Fatigue overlaps often with other symptoms such as somnolence,~     depression and cognitive disorders, from which it is not always readily distinguished. The~     evaluation of fatigue and the three most frequently associated symptoms using a~     multidimensional approach might allow to understand, which methodology is the best indicated~     to estimate the prevalence of fatigue with greatest accuracy, leading to a better~     differentiation of the symptoms in the diagnostic setting.~   "
74783|NCT02078466|"~     The aim of this study is to examine the effect of an intervention that consist of assessment~     of functional ability, rehabilitation plan and follow-up at home for older medical patients.~      The hypothesis is that assessment of functional ability, development of rehabilitation plan~     and follow-up at home reduce the older medical patient's risk of readmission. Also the~     intervention is expected to reduce mortality, number of contacts to general practitioners~     and emergency physician~   "
74514|NCT02081989|"~     Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be~     an effective treatment for high blood pressure. It is currently being tested in heart~     failure patients and we would now like to look it its effects on diabetes.~      We therefore plan to enrol 20 participants with type II diabetes into this study. Half will~     undergo renal denervation in addition to their standard care and the other half will act as~     controls and only receive standard care. Treatment allocation will be randomly assigned.~      All participants will undergo screening (including a physical exam, blood tests, ultrasounds~     and a muscle biopsy). All patients will have follow up tests (including physical exams and~     blood tests) 1, 3 and 6 months later.~   "
74515|NCT02081976|"~     Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity~     all over the world. In the last years, efforts have been made to define more effective~     therapeutic and preventive strategies.Periodontal diseases have been considered a probable~     risk factor for CVD with a great amount of evidence from observational studies. Although~     there are some interventional studies evaluating the systemic effects of periodontal~     therapy, there is little information regarding the impact of periodontal treatment on the~     prevention of cardiovascular events. To the best of our knowledge, there are no randomized~     controlled trials published to date assessing the effect of periodontal therapy in primary~     prevention of CVD.~   "
74516|NCT02081963|"~     This is a multi-centered, randomized, controlled study to assess the efficacy, indications~     and adverse reactions of combined administration of nebulized amikacin in patients with~     acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled~     antibiotics are more likely to cause bacterial resistance.~   "
74517|NCT02081950|"~     This is a pilot, open-label study aimed at a preliminary evaluation of enoxaparin~     bioavailability following two administrations of Clexane s.c. at a dose of 80mg, in two~     different periods.~   "
74518|NCT02081937|"~     Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling~     domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an~     escalating dose. After completion of study treatment, patients are followed intensively for~     6 months, every 3 months for 2 years, and annually thereafter for 10 years.~   "
74519|NCT02081924|"~     The purpose of this study is to determine the physiological effects of sustained~     administration of the natural hormone kisspeptin on reproductive function in participants~     with reduced fertility. Kisspeptin is a recently identified natural hormone which is~     regulates human reproduction. Learning more about the physiological role of kisspeptins may~     therefore give us a better understanding about human fertility, and improve the management~     of patients with reduced fertility. The effects of sustained administration of kisspeptin on~     hypothalamic reproductive function (i.e. Luteinising hormone pulsatility) are not known.~   "
74520|NCT02081911|"~     The purpose of this study is to investigate whether there is quantitative motor-sparing of~     the quadriceps muscles following adductor canal nerve block versus femoral nerve block.~     Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block,~     2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume.~     Quadriceps function will be assessed in the operating room using a skin patch and electrical~     stimulation. Follow up visits with the patients will continue over the course of 2 days~     during patient's stay at the hospital. A total of 60 patients will be enrolled for the~     study.~   "
74521|NCT02081898|"~     The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is~     unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in~     the extended plasma metabolites.~   "
74522|NCT02081885|"~     Introduction After a mandibular fracture where bone has been lost, a number of complications~     and challenges are presented in trying to solve them. These defects are mainly classified~     into two groups: functional and cosmetic. The functional defects are incompetence of the~     lower lip, salivary incontinence, severe difficulty chewing and swallowing,~     temporomandibular joint disorders and difficulty in pronouncing words.~      Esthetically facial asymmetry is produced with collapse of the affected side.~     Unreconstructed jaw retrusion and tends to offset the affected side, there is a change in~     mandibular movements, which, previous vertical movements are replaced by oblique or diagonal~     movements controlled by a single temporomandibular joint. It also presents a limitation in~     motility and lingual force, besides proprioception disorder left by the inferior alveolar~     nerve The loss of bone in mandibular fractures, is one of the great challenges facing~     maxillofacial surgery and unfortunately increasingly common. That's why they have done and~     are still doing research for the development of biomaterials, all with the purpose of trying~     to solve this problem by offering the patient better results than those obtained in the~     past, restoring both function and facial aesthetics according to each case~   "
74523|NCT02081872|"~     UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians~     manage patient medication regimens and assess if the testing has an effect on reducing~     adverse drug reactions, hospitalizations and emergency department visits.~      The way an individual processes a drug is in part determined by their genes, and there is~     known to be genetic variation between humans in the way drugs are metabolized. The study of~     the way genes affect a person's response to drugs is known as Pharmacogenomics.~   "
74524|NCT02081859|"~     This is a randomized controlled observational trial to determine if data obtained from the~     embryoscope is helpful in determining which blastocysts to transfer.~   "
74525|NCT02081846|"~     Home Nurse Visit post discharge.~   "
74526|NCT02081833|"~     This study serves as a feasibility study for a birth cohort study to investigate the~     influence of the sequence and load of infections and vaccinations on the development of the~     immune system of children. In this study, the investigators aim to test the methods~     developed to capture acute respiratory and gastrointestinal infections and their~     consequences of children aged 1 to 3 years in Braunschweig, Germany. Furthermore, the~     investigators want to study the influence of the environment on the microbiome of children~     by comparing children of the same child care centre with children from different child care~     centres. The methods developed include a symptom diary which has to be filled out on a daily~     basis by the parents. Furthermore parents are asked to take monthly anterior nasal swabs and~     stool samples from the study child independent from symptoms as well as one sample if~     symptoms occur. The parents are provided with instructions and the first nasal swab will be~     demonstrated by trained study personal. The study is powered to compare nasal swabs taken by~     the trained staff and the parents as primary outcome. Secondary outcome is the performance~     of reminders sent to the study participants. The diary and the specimen will be mailed to~     the Helmholtz Centre for Infection Research where they will be analyzed for the nasal and~     gut microbiome. The nasal swabs taken at the time of an infection will be tested for~     respiratory viruses. After the study period of 3 months parents will be asked about the~     feasibility and acceptance of the symptom diary and taking the nasal swabs and stool~     specimens by means of questionnaires and interviews (face to face and focus groups). This~     will help our understanding of the feasibility and acceptance of the methods developed to~     capture acute respiratory and gastrointestinal infections of children and our understanding~     of the development and composition of the nasal and gut microbiota.~   "
74527|NCT02081820|"~     In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is~     considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to~     estimate the average plasma glucose concentration over prolonged periods of time, thus~     determination of glycated hemoglobin at admission after aSAH serves as an approximation of~     blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry~     admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to~     determine whether elevated blood glucose levels prior to aneurysm rupture influence the~     clinical course and patient outcome after aSAH.~   "
74528|NCT02081807|"~     This cohort study is the sequential expansion of the comparative effectiveness study of oral~     anticoagulants and plans to identify initiators of oral anticoagulants using electronic~     claims data from a commercial insurance database to quantify associations between~     anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in~     patients with non-valvular atrial fibrillation at risk for stroke.~   "
74529|NCT02081794|"~     This randomized pilot clinical trial studies tailored patient educational intervention or~     standard education in assessing perceived risk for falls in hospitalized oncology patients.~     A tailored patient educational intervention may be more beneficial than standard education~     in preventing patients from falling by increasing the patient's knowledge of the risk~     factors for falling routinely and then providing education in deficit areas. Making patients~     more aware of the risk factors for falling may lead to greater engagement in preventative~     activities.~   "
74530|NCT02081781|"~     The purpose of this study was to investigate various potential factors that affected the~     outcome of treatment of congenital nasolacrimal duct obstruction.~   "
74531|NCT02081768|"~     There is no consensus in the literature on the best way to treat cystic lesions of the~     pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of~     tumours present special challenges since traditional treatment modalities (surgery and/or~     external radiation) are often not able to completely remove or treat the cyst wall without~     major morbidity or even mortality.~      There is no 'best practice' for the treatment of cystic tumours per se. Treatments available~     to patients with cystic sellar/parasellar tumours include conservative management using a~     'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or~     craniotomy approach (i.e. open surgery). Over the last 10 years we have treated~     approximately 8 patients with intracystic radiotherapy. All of these patients continue to be~     monitored clinically and radiologically and all have done well with stable regression of the~     cysts and no new neurological deficits. Over the past 2 years, 90yttrium colloid has been~     provided to CDHA through Health Canada's Special Access Program (SAP). It has only been of~     recent that Health Canada has requested a clinical trial to assess the benefit of~     intracystic radiotherapy over other available treatment options.~      The experimental treatment being proposed is the stereotactic intracavitary instillation of~     90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding~     areas (parasellar).~   "
74532|NCT02081755|"~     This study is a prospective Phase IV study to determine if the use of Everolimus results in~     lower liver tumor recurrence and improved patient and graft survival after liver transplant~     for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and~     Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil.~     Primary outcomes data is disease free survival (the time from randomization to HCC~     recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems~     related to wound healing, hernia repair within the first 12 months, hepatic arterial~     thrombosis, renal function, acute cellular rejection, post-transplant diabetes,~     hypertension, and hyperlipidemia.~   "
74533|NCT02081742|"~     Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in~     Spain (11,000 deaths per year). Screening of the population over 50 years of age with no~     significant history (intermediate risk) is recommended, but which screening method is best~     for promoting adherence in this type of patient has not been well established. There are~     currently two screening methods that are less invasive than conventional colonoscopy and~     seem to have higher sensitivity than the test for faecal occult blood (FOBT). These two~     methods are the colon capsule, which consists in ingesting a capsule that takes photographs~     of the colon, and virtual colonoscopy, which is a radiological technique.~      Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC~     screening techniques in the intermediate risk population, with diagnostic rates comparable~     to conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon~     capsule and virtual colonoscopy with respect to the size and characteristics of the lesions~     visualised. 3. To compare the participation rates for each screening strategy and identify~     the factors that influence participation (individual, family, and socioeconomic factors as~     well as those relating to the doctor).~   "
74534|NCT02081729|"~     VZV is one of the important opportunistic infection in transplant recipients.Until now,~     there is no laboratory method to stratify the risk of VZV reactivation after solid organ~     transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ~     transplantation will further categorize the patients into high or low risk of VZV~     development after solid organ transplantation. The investigators thus evaluate the~     usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the~     development of VZV infection after kidney transplantation.~   "
74535|NCT02081716|"~     CMV is one of the most important opportunistic infection in transplant recipients. In South~     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now,~     sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of~     choice to stratify the risk of CMV reactivation after solid organ transplantation.~     Theoretically, CMV-specific cell-mediate immune response before and after bone marrow~     transplantation will further categorize the patients into high or low risk of CMV~     development after bone marrow transplantation. The investigators thus evaluate the~     usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the~     development of CMV infection after transplantation.~   "
74536|NCT02081703|"~     The objectives of this study are to evaluate the safety and analgesic efficacy of a single~     preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.~   "
80558|NCT02002975|"~     This study is designed to determine the onset of new cerebral and cardiovascular events and~     changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on~     long-term pioglitazone (Actos Tablets) treatment.~   "
74537|NCT02081690|"~     Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.~      Primary objectives: To evaluate the psychometric characteristics of reliability and~     construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.~      To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to~     detect change.~      Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial~     hypertension (PAH).~      Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact~     (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.~   "
74538|NCT02081664|"~     Some patients report relief of symptoms after amalgam removal. However, a large group of~     patients are still suffering from partly severe health complaints even after the removal of~     amalgam. To date, no biological/medical explanation for these Amalgam attributed health~     complaints is available.~      The objective of this study is to develop an integrated medical care rehabilitation program~     and determine if it is a valid and feasible treatment for patients with persistent symptoms~     after amalgam removal. Such a comprehensive concept has to date not been operationalized in~     Norway, but information about the feasibility and the challenges around such a~     rehabilitation program are required, in order to prepare for a possible controlled and~     randomized study evaluating the effects of the suggested integrative care treatment program.~     This treatment program will focus on learning by practicing, hence the study participants~     will be enrolled into a group program focusing on life-style changes. In addition to the~     life-style oriented group program, an individualized treatment strategy with therapies out~     of the spectrum of Complementary and Alternative Medicine (CAM) will be part of the~     treatment program. This part of the program is based on the results of a survey, related to~     use of CAM therapies, conducted in 2012 among the members of the patient organization~     Forbundet Tenner og Helse.~      Participants of this treatment program must amongst other inclusion criteria have removed~     all dental amalgam fillings and experience symptoms which have not disappeared after removal~     of the dental fillings. Specific exclusion criteria are stated. The group program consists~     of 12 sessions which are held once per week for a whole day. Added to this is a choice of~     CAM therapies from a hierarchic list, established from the survey, and which accordingly is~     based on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks~     (end of treatment), and three month later. The aim of this study is to test the feasibility~     of an integrated medical care rehabilitation program for patients in Norway who have had~     their Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It~     combines a lifestyle oriented group program with individualized CAM therapies in form of an~     outpatient program.~   "
74539|NCT02081651|"~     Cow's milk allergy is the most common food allergy in children. The scenery clinical and~     epidemiological of cow's milk allergy is significantly changed in the last decade. The~     severity of the clinical manifestations is still rising, and now cow's milk allergy has~     become the leading cause of hospitalization for food -induced anaphylaxis in our country. In~     addition, the overall prevalence of cow's milk allergy is increasing for a gradual reduction~     in the ability to acquire immunological tolerance to cow's milk protein in the first years~     of life. These mutations dictate the need to identify strategies to stimulate the~     acquisition of immunological tolerance in children affected by cow's milk allergy . The~     mechanisms of acquired immunological tolerance are not yet fully defined . The current view~     suggests the existence of a dynamic mechanism , consisting of various cellular compartments~     , which is set in a crucial environmental factors arising mainly from the diet and its~     effects on the intestinal microbiota. These acquisitions have contributed to the definition~     of a new concept in the field of human nutrition: immunonutrition. The immunonutrition is~     the ability, through the intake of specific nutrients on the immune system to interfere~     directly or indirectly through modulation of the composition and function of the intestinal~     microbiota. The proponent group has recently shown that it is possible to stimulate a more~     rapid acquisition of immunological tolerance in children affected by CMA through the~     administration of extensively hydrolysed casein containing the probiotic Lactobacillus~     rhamnosus GG (LGG) (Berni Canani et al. J Pediatr 2013) . Several lines of evidence suggest~     that this effect is induced by a combination of direct immunomodulatory action exerted by~     some small peptides derived from the beta - casein and the action of lactobacillus GG. It 's~     well known that the Lactobacillus GG is able to adjust the composition and functions of the~     microbiota in the child with CMA and directly adjust some immunological mechanisms involved~     in the pathogenesis of this condition. At the same time other groups have demonstrated the~     possibility that a high percentage of patients with IgE-mediated CMA is able to tolerate~     foods containing hydrolyzed cow's milk proteins with different processes. It has also been~     speculated that these strategies can facilitate the acquisition of immune tolerance in~     patients with cow's milk allergy. One of these foods is Parmigiano -Reggiano cheese, which~     is characterized by an ' extensive hydrolysis of the proteins in cow's milk , which degrade~     the caseins present and generate large amounts of peptides and free amino acids and by the~     presence of appreciable quantities of Lactobacillus GG in the samples to maturing higher .~     In a recent study it was shown that 58% of patients suffering from IgE-mediated CMA is able~     to tolerate a daily intake of normal amounts of this food , especially in the absence of a~     sensibilization to IgE specific to the beta lactoglobulin. These new findings allow us to~     hypothesize the use of Parmigiano REggiano cheese as a possible strategy immunonutrition can~     stimulate the acquisition of immune tolerance in patients with CMA .~   "
74540|NCT02081638|"~     Background:~      - The immune system protects the body from infection. But it can also cause harm. For~     example, the clotting system makes blood clot and protects from bleeding. But blood clots~     are sometimes harmful. People with human immunodeficiency virus (HIV) infection have~     increased inflammation and clotting. This may increase their risk for diseases like stroke~     or heart attack. Researchers want to know how aspirin or HMG-CoA reductase inhibitors~     (so-called statin medications) affect the immune and clotting systems of people with HIV.~     Aspirin is a medicine to decrease clotting. Statins are medications given to lower~     cholesterol and decrease inflammation.~      Objectives:~      - To see how aspirin or statins change immune and clotting systems in people with HIV.~      Eligibility:~      - Adults 18 and older with HIV and a low viral load, not on aspirin or a statin medication.~     They must also have either: (1) never taken anti-HIV medications (ARVs), have a suppressed~     viral load, have stable CD4 counts, and never had an opportunistic infection; or (2) been~     taking ARVs for 5 continuous years and have a suppressed viral load for more than 3 years.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and lab~          tests.~        -  Participants will repeat screening tests and have an MRI. An MRI is a way to visualize~          blood vessels in the neck and head. Participants will lie on a table that slides in and~          out of a cylinder surrounded by a magnetic field.~        -  Participants will take either study drug once daily for 9 months.~        -  Participants will have a blood procedure twice. Blood will be removed through a needle~          in one arm and circulated through a machine that removes white blood cells. The blood,~          minus white blood cells, is returned through a needle in the other arm.~        -  All participants will be observed for 3 months before and after treatment.~   "
74541|NCT02081625|"~     This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics~     (PK) of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).~   "
74542|NCT02081612|"~     This study looks at the benefit of adding acupuncture to nutrition education for weight loss~     in women with early stage breast cancer post-chemotherapy.~   "
74543|NCT02081599|"~     The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in~     combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to~     evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an~     extension treatment for up to 52 weeks.~   "
74544|NCT02081586|"~     A significant problem in primary care healthcare delivery is the lack of interventions to~     improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM).~     Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications,~     and self-management burdens is present in up to 70% of persons with T2DM. Distress is a~     significant factor in medication nonadherence and poor glycemic control. Treatment adherence~     is vital to maintain glucose control and reduce complications.~      The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't~     handle taking these medications), assumptions (e.g., I know I will have side effects to~     these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff)~     as critical variables that impact both distress and T2DM treatment adherence. Current~     treatment strategies within primary care do not address the dysfunctional thinking patterns~     that affect the patient's distress level, T2DM medication adherence, and complex daily~     self-care activities.~      Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps~     patients to identify, and restructure dysfunctional thinking patterns. The investigators~     propose to test a brief phone CBT approach that is supported by a comprehensive mobile phone~     CBT skills practice application (app) within primary care. The promising results of the~     investigators preliminary studies using a mobile phone app to stimulate real-time CBT skills~     practice prompt us to propose a pilot of its use with patients with T2DM with the following~     aims:~      Primary aim: examine feasibility and acceptability of the assessment protocol, and the~     recruitment, and retention of study participants.~      Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical~     outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g.,~     diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM~     outcomes (HbA1c level and body mass index).~   "
74545|NCT02081573|"~     A significant problem in primary care healthcare delivery is the lack of interventions to~     improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM).~     Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications,~     and self-management burdens is present in up to 70% of persons with T2DM. Distress is a~     significant factor in medication nonadherence and poor glycemic control. Treatment adherence~     is vital to maintain glucose control and reduce complications.~      The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't~     handle taking these medications), assumptions (e.g., I know I will have side effects to~     these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff)~     as critical variables that impact both distress and T2DM treatment adherence. Current~     treatment strategies within primary care do not address the dysfunctional thinking patterns~     that affect the patient's distress level, T2DM medication adherence, and complex daily~     self-care activities.~      Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps~     patients to identify, and restructure dysfunctional thinking patterns. We propose to test a~     brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile~     phone CBT skills practice application (app) within primary care. The promising results of~     our preliminary studies using a mobile phone app to stimulate real-time CBT skills practice~     prompt us to propose a pilot of its use with patients with T2DM with the following aims:~      Primary aim: examine feasibility and acceptability of the assessment protocol, and the~     recruitment, and retention of study participants.~      Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical~     outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g.,~     diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM~     outcomes (HbA1c level and body mass index).~   "
74546|NCT02081560|"~     The blood concentration of the antibiotic colistin is determined in patients in whom kidney~     function is reduced such that a renal replacement therapy is needed.~      Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement~     therapy over 24h because colistin is sufficiently removed by this procedure.~   "
74547|NCT02081547|"~     Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%.~     Local recurrence rate after curative surgery varies between 3-7% in the variety of regions~     in the country. It is well known that the surgical technique total mesorectal excision (TME)~     has led to improved prognosis after rectal cancer surgery. TME surgery is difficult to~     perform and different factors affect the quality of TME preparations. Injuries in mesorectal~     fascia has been reported in up to 20% of patients who underwent TME surgery and most~     surgeons agree that this may be important for recurrences. However, it is unclear to what~     extent a damaged mesorectal fascia can be related to a worsening of prognosis in patients~     with rectal cancer.~      Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients~     with unfavorable tumors based on the pathological examination. Patients with favorable~     tumors (less advanced) are not offered chemotherapy, even if the surgical technique was not~     optimal, ie. that there is damage in the mesorectal fascia, as evidence for this is lacking.~      The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor~     stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer~     patients with tumors below the peritoneal reflection) is unclear.~      Assessment of IPC status with cytology and immunohistochemistry is technically easy and~     could after TME surgery identify those patients who have an increased risk of tumor~     recurrence. In a positive IPC status, the patient would possibly benefit from either~     postoperative radiotherapy if the patient did not receive preoperative therapy, or~     postoperative oncological chemotherapy.~      Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and~     the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer~     is routinely occurring and the clinical benefit has not been established. The value of~     rinsing the abdomen after TME-surgery could also be studied by IPC status.~      The study hypothesis is that the IPC status is dependent on the surgical quality of the~     specimen after TME-surgery in rectal cancer patients, and its presence leads to increased~     risk of local recurrence.~   "
74548|NCT02081534|"~     Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4~     weeks treatment period~   "
74549|NCT02081521|"~     Control of diarrhoeal disease requires a comprehensive package of preventive and curative~     interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED)~     aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour~     change component of the PAED programme seeks to change behaviours important for diarrhoea~     prevention (handwashing with soap and exclusive breastfeeding) and improved treatment~     outcomes (use of oral rehydration solution (ORS) and zinc in home management of child~     diarrhoea).~      The study aims to evaluate the feasibility of implementing a multiple behaviour change~     community programme to tackle diarrhoeal disease in children under-five and to assess the~     impact of this programme on practice of the target behaviours by caregivers of children~     under-five. The research questions will be answered through a a two-arm cluster-randomised~     trial (eight clusters per study arm).~   "
74550|NCT02081508|"~     The purpose of this research study is to investigate whether minimizing interference~     improves memory in multiple sclerosis.~   "
74551|NCT02081495|"~     The purpose of this study is to support the qualification of a replacement manufacturing~     site for DOXIL/CAELYX.~   "
74552|NCT02081482|"~     The occipital nerve stimulation (ONS) is used to treat patients with refractory primary~     chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis~     have been suggested in particular a specific action on cerebral generators involved in~     different types of primary headaches or a non specific action on pain modulatory network.~      The aim of this study, using the chronic cluster headache as a model, is to determine the~     changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary~     chronic headache.~   "
74553|NCT02081469|"~     To evaluate the effectiveness and safety of tenofovir for different treatment duration in~     preventing HBV relapse in patients with malignancies after receiving chemotherapy and~     off-treatment of chemotherapy.~   "
74554|NCT02081456|"~     The purpose of this study is to investigate effects of soft tissue mobilization versus~     therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical~     sensitivity.~   "
74555|NCT02081443|"~     Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of~     action associated with a greater reduction in ischemic events, including stent thrombosis,~     in patients undergoing stent procedures who have not been pretreated with clopidogrel. In~     vitro investigations have shown cangrelor to be associated with more rapid, potent, and~     consistent platelet inhibition in patients on maintenance prasugrel therapy exposed to a~     re-loading dose of prasugrel. However, if cangrelor exerts similar effects in ticagrelor~     treated patients remain unknown. The aim of the present study is to evaluate the effects on~     platelet function achieved after in vitro incubation with cangrelor in patients on~     ticagrelor maintenance dose who receive a loading dose of ticagrelor.~   "
74556|NCT02081430|"~     The purpose of this study is to determine the immediate effects of cervicothoracic~     manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and~     cervical ROM.~   "
74594|NCT02080936|"~     Peripheral muscle mass and strength are relevant indicators of COPD survival. Current~     guidelines recommend to assess muscle strength only in muscle wasted patients. However, a~     recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp.~     Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In~     clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess~     muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary~     rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of~     muscle wasting clinical signs.~   "
74557|NCT02081417|"~     Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience,~     has the potential to increase access to trauma treatment in underserved communities. This~     could positively impact the lives of millions of people as 70% of adults in the U.S have~     experienced a traumatic event and the consequences of trauma are devastating and far~     reaching, including chronic and comorbid physical and mental health problems. The most known~     consequences of trauma include post-traumatic stress disorder (PTSD) and substance use~     disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for~     co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required~     to conduct SS, all the evidence comes from studies using trained clinicians to implement the~     treatment, including social workers, psychologists, and psychiatrists. However, these~     research findings do not generalize to underserved communities that lack mental health~     professionals. Innovative approaches to treatment, such as peer-delivered services, are~     required to meet the demand for care in underserved areas. While the benefits of~     peer-delivered services have been well-documented in many areas, the value of peers in the~     provision of trauma-treatment is unknown. A theoretical basis supports the potential for~     peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient~     bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome~     and a typical result of peer-patient relationships.~      Our research question is whether there is a difference between peer-led SS (PL-SS) groups~     and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and~     SUDs?~      The investigators have three specific aims:~        1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing~          substance use and PTSD symptoms and improving coping skills, overall mental health and~          physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in~          improving outcomes.~        2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on~          outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in~          impacting outcomes in the PL-SS compared to CL-SS groups.~        3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for~          peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.~   "
74558|NCT02081404|"~     Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population,~     is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with~     reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux~     disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks~     and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of~     NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters~     (incorporated into standard endoscopes) and helps to see abnormal areas not identified~     during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a~     significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of~     this study is to accurately diagnosis non acid reflux disease by using a blue light (also~     known as NBI)upper endoscopy technique.~   "
74559|NCT02081391|"~     The purpose of the study is to evaluate the efficacy of tapentadol oral solution, based on~     the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after~     initiation of investigational medicinal product in children and adolescents who have~     undergone surgery that would produce moderate to severe pain during opioid treatment.~   "
74560|NCT02081378|"~     The design of a phase I, open label, dose finding study was chosen in order to establish a~     safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed~     or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and~     ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.~   "
74561|NCT02081365|"~     Dental and health anxiety are common and potentially distressing problems, for both patients~     and health care providers. Anxiety has been identified as a barrier to regular dental visits~     and as an important target for enhancement of oral health-related quality of life. possible~     groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and~     evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT)~     that could be easily implemented in dental healthcare settings.~      A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental~     procedures, and cognitive restructuring was developed. A randomized controlled trial was~     conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion~     (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1)~     immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).~   "
74562|NCT02081352|"~     This study has been designed to help determine how safe and effective DermaPure™ may be in~     treating hard-to-heal diabetic foot ulcers compared to the current standard of care.~   "
74563|NCT02081339|"~     Recent clinical introduction of anti-vascular endothelial growth factor agents may change~     the clinical course of macular diseases, including age-related macular degeneration (AMD),~     polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central~     serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein~     occlusion (RVO), diabetic macular edema (DME), and so forth.~      Patients with such macular diseases are registered and and are followed up for 5 years with~     appropriate treatment for each patient. By the analysis of the correlation between initial~     examinations and final visual acuity, factors associated with good visual prognosis will be~     elucidated.~   "
74564|NCT02081326|"~     The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations~     can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I~     data on repeat BCG vaccinations in long term diabetics showed specific death of some of the~     disease causing bad white blood cells and also showed a short and small pancreas effect of~     restored insulin secretion. In this Phase II study, the investigators will attempt to~     vaccinate more frequently to see if these desirable effects can be more sustained.~      Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of~     four years or receive a placebo treatment. The investigators hypothesize that each BCG~     vaccination will eliminate more and more of the disease causing white blood cells that could~     offer relief to the pancreas for increased survival and restoration of insulin secretion~     from the pancreas.~   "
74565|NCT02081313|"~     This study aims at studying the natural history of Netherton syndrome (NS), to identify the~     consequences of LEKTI deficiency on the immune system and to characterize new molecular~     mechanisms involved in the disease.~   "
74566|NCT02081300|"~     The purpose of this study is to determine the safety and efficacy of an oral testosterone~     undecanoate formulation for use as testosterone-replacement therapy in men with low~     testosterone.~   "
74634|NCT02080403|"~     The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine~     gluconate chip) in the treatment of patients with Peri-implantitis.~      The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival~     debridement is more effective in the treatment of peri-implantitis when compared to the~     common method of mechanical subgingival debridement alone. The primary efficacy measure will~     be the reduction in probing pocket depth at 6 months as measured at sites of qualifying~     target implant.~   "
74567|NCT02081287|"~     Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a~     naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown~     preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in~     bipolar disorder in some studies, but failed to establish efficacy in subsequent~     meta-analyses. In the investigators proposed work, the investigators plan to orally~     administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to~     paid research subjects with a diagnosis of bipolar disorder who are in a depressed state,~     and who have failed an adequate course of treatment with lithium monotherapy. The~     investigators hypothesis is that IP6 may be similar to myo-inositol in terms of relieving~     depression, but more potent and effective. Our aim is conduct a preliminary pilot study in~     30 subjects (15 treated with IP6, 15 treated with lamotrigine, an active comparator) to~     assess the efficacy and tolerability of IP6 as an adjunctive treatment to lithium, the mood~     stabilizer most commonly used to treat bipolar disorder.~   "
74568|NCT02081274|"~     High tidal volume during mechanical ventilation has been reported to increase mortality in~     patients with acute lung injury or acute respiratory distress syndrome. High tidal volume~     was also reported to be associated with increased mortality in adult patients without acute~     lung injury or acute respiratory distress syndrome. However, the influence of high tidal~     volume on clinical outcome in pediatric patients who underwent surgery for congenital heart~     disease has not been evaluated yet. The investigators attempted to evaluate the effect of~     tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.~   "
74569|NCT02081261|"~     Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and~     has been reported to be associated with adverse outcome. There have been many studies~     reporting risk factor of acute kidney injury after cardiac surgery, but the influence of~     perioperative variables related to anesthesia and perioperative medication has not been~     evaluated fully. The investigators attempt to evaluate the influence of perioperative~     clinical variables including preoperative medication, preoperative albumin level, uric acid~     concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level,~     intraoperative medication, perioperative cardiac function (systolic and diastolic function)~     and hemodynamic variables during surgery on the incidence of acute kidney injury after~     coronary artery bypass graft.~   "
74570|NCT02081248|"~     The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and~     (2) Evaluation Study to understand barriers to implementation of ETRIC.~   "
74571|NCT02081235|"~     Acute kidney injury (AKI) is a major complication after cardiac surgery and has been~     reported to be associated with adverse outcome. Previous studies have reported that the~     incidence of AKI in patients undergoing surgery for congenital heart disease is as high as~     42% and AKI increase the patient mortality, intensive care unit stay and hospital stay.~     Previous studies have reported several risk factors for AKI after congenital heart surgery,~     however, perioperative variables including anesthesia-related factors have not been~     evaluated fully. Therefore, the investigators attempt to find out independent risk factors~     regarding perioperative variables.~   "
74572|NCT02081222|"~     Viscoelastic hemostatic assay has been reported to be superior to predict perioperative~     bleeding in cardiac surgical patients compared with conventional blood coagulation test.~     However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative~     bleeding and transfusion requirements in pediatric patients who undergoing surgery for~     congenital heart disease. Therefore, the investigators attempt to evaluate the~     predictability of intraoperative rotational thromboelastometry for perioperative bleeding~     and transfusion requirements in pediatric cardiac surgical patients by comparing with~     conventional coagulation test. The investigators also attempt to evaluate the correlation~     between ROTEM parameters, platelet count, and results of conventional coagulation test~     results.~   "
74573|NCT02081209|"~     The purpose of this study is to compare the performance of a cryolipolysis system using~     various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral~     thighs.~   "
74574|NCT02081196|"~     The purpose of this study is to evaluate the safety and efficacy of non-invasive~     subcutaneous fat layer reduction with an alternative treatment parameter.~   "
74575|NCT02081183|"~     This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)]~     and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance~     treatment for patients with lupus nephritis. All patients will receive induction treatment~     with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the~     maintenance phase of the study for a further 6 months, followed by 6 months of~     treatment-free follow-up. The anticipated time on study treatment is 12 months.~   "
74576|NCT02081170|"~     The purpose of this study is to determine the effectiveness of intravitreal autologous~     platelet concentrate (APC) injection during the surgery for refractory macular holes.~   "
74577|NCT02081157|"~     This study is to assess the physician preference in the clinical performance of the GalaFLEX~     mesh in soft tissue reinforcement during elective (cosmetic) plastic surgery to the breast,~     in particular the breast lift mastopexy and breast reduction procedures~   "
74578|NCT02081144|"~     This is a pilot study to test the feasibility of conducting a text based smoking cessation~     trial with Emergency Department patients who are smokers.~   "
74579|NCT02081131|"~     The aim of this study is to compare the two surgical approaches namely laparoscopic~     pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and~     pancreatic head cancers in terms of parameters like hospital stay, pathological radicality,~     complication rate, peri-operative and post operative outcomes.~   "
74580|NCT02081118|"~     The purpose of this study is to determine the optimal dose or doses of HM11260C, when~     administered once a month under the skin, to improve the control of blood sugar levels in~     patients with early-stage type 2 diabetes mellitus (T2DM).~   "
74635|NCT02080390|"~     The purpose of this research study is to evaluate the effects of the chemotherapeutic drug,~     Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific~     types of breast cancer and is known to cause weakening of the heart. Unfortunately, little~     is know as to why this this happens. The investigators want to identify any factors that may~     lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem)~     associated with this drug.~   "
74581|NCT02081105|"~     Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP)~     selection in ARDS patients. It is defined as the potential for the non aerated or poorly~     aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes~     to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at~     the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the~     repeated opening and closing of them during the breathing cycle, which is implicated in a~     further lung inflammation. The gold-standard method for assessing lung recruitability is~     lung CT scan. For economic and feasibility this technique cannot be used in routine.~     Therefore, techniques that can be used at the bedside to measure lung recruitability are~     very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume~     curve generated by the ventilator is another reference method to approach lung recruitment.~     It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine~     in this setting. Furthermore, it allows quantifying aeration thanks numerical image~     processing and a regional approach. In a preliminary one-center study we found a significant~     negative correlation between the amount of Vrec and the reduction in lung density measured~     by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this~     previous result on a larger number of patients in a multicenter investigation.~   "
74582|NCT02081092|"~     The purpose of this study is twofold: to assess routine cat scan (CT) imaging as a biomarker~     for removal of lipoprotein surfactant via lung lavage (where CT is the gold-standard imaging~     technique for density quantification), and to utilize a novel UTE MRI protocol to similarly~     quantify surfactant removal. This study will also serve to generate baseline scanning that~     may aid in developing analytical tools to evaluate and treat specific lung regions of~     patients with PAP.~   "
74583|NCT02081079|"~     This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir~     (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5~     hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained~     virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12~     weeks after discontinuation of therapy.~   "
74584|NCT02081066|"~     The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of~     free cholesterol from peripheral tissues, including the vessel wall, to the liver represent~     the primary mechanism by which HDL protects against atherosclerosis and by which it may~     induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol~     from macrophages, a metric of HDL function reflecting the initial step of the RCT, is~     clinically relevant, displaying a strong inverse association with both carotid intima-media~     thickness and the severity of angiographic CAD; such observations were independent of HDL-C~     levels.~      In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT~     pathway and mediates redistribution of neutral lipids between lipoproteins, has been~     identified as a potential therapeutic target against atherosclerosis. It is known that CETP~     activity correlates with HDL-C levels and represents a key modulator of the ability of whole~     plasma to mediate free cholesterol efflux from human macrophages.~      Recent studies showed that 23% of endogenous plasma CETP activity variability is explained~     by plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together~     for only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of~     their plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high~     cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%.~     Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in~     patients with metabolic disorders since it integrates major independent risk factors.~      The objective of this study is to decipher the relationship between CETP, HDL efflux~     capacity and the development of atherosclerosis in humans in order to identify CETP as a~     potent biomarker of atherosclerosis distribution.~   "
74585|NCT02081053|"~     To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor~     ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful~     metastatic lesions in the spine.~   "
74586|NCT02081040|"~     To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during~     coughing and compare them to those with supratentorial brain lesion patients with dysphasia~     and those with no dysphagia at a university affiliated rehabilitation department.~   "
74587|NCT02081027|"~     Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting~     drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).~   "
74588|NCT02081014|"~     The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen~     Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to~     moderate hypoglycemia, a complication of diabetes.~   "
74589|NCT02081001|"~     The purpose of the study is to assess the safety, speed of absorption, and onset of action~     of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®,~     all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.~   "
74590|NCT02080988|"~     To assess coughing force during reflex coughing test in those with severe dysphagia and~     severe aspiration and compare them to than those with stroke patients with no signs of~     dysphagia/aspiration.~   "
74591|NCT02080975|"~     Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions~     by delivering energy while maintaining adequate catheter contact with the endocardium.~     Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation~     catheter lacks clear indications of contact. We propose to use the Boston Scientific~     IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by~     the mini-electrodes on the ablation tip could help confirm tissue contact. Using an~     ultrasound catheter to define instances of clear contact and non-contact, we will determine~     whether the micro-electrodes produce sufficient information to confirm catheter contact. We~     propose that the MiFi catheter produces sufficient signal characteristics that can be used~     as an effective surrogate for adequate tissue contact.~   "
74592|NCT02080962|"~     Radiotherapy is a treatment considered standard for non melanoma skin cancer. This~     institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to~     perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.~   "
74593|NCT02080949|"~     Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment~     is based on whole brain radiation therapy and local treatment of metastases as neurosurgery~     or radiosurgery. However, many cases can not receive a standard local treatment, and local~     relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are~     retrospective studies of increased radiation dose at the site of metastasis with~     hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no~     controlled studies regarding the safety of radiation dose in these situations. This study is~     a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase~     the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for~     surgery or RS.~   "
74595|NCT02080923|"~     The proposed study is a test of the feasibility and preliminary efficacy of a brief~     motivational interview style intervention. The intervention will take place in the pediatric~     emergency department of the Boston University Medical Center by a trained interventionist~     and will follow an intervention manual developed by a team of dating abuse and brief~     intervention experts. The study will involve two randomized groups of youth age 16-18: one~     group will receive the intervention and the other will not. The study will compare changes~     in data from baseline to 3- and 6-month follow-up for those in both groups. Outcomes~     including dating abused related knowledge, attitudes about the use of violence to resolve~     conflict, and dating abuse behavior (perpetration and/or victimization) will be assessed.~      The hypothesis of this study is that youth who receive the intervention will show~     improvements in dating abuse related knowledge, attitudes and behavior that are maintained~     for 6 months, while those in the control group will show no similar change.~   "
74596|NCT02080910|"~     This is a randomized controlled trial with a 3-month psychoeducational program as~     intervention, followed by a 3 month observational period. The purpose of this study was to~     examine whether a psychoeducational program focusing on equipping caregivers with~     problem-solving skills would improve caregiver's problem-solving abilities, their~     psychological responses and caregiving resources, and would minimize the use of health and~     social services among stroke survivors.~   "
74597|NCT02080897|"~     The purpose of this study is to evaluate the role of palliative surgery in improving Quality~     of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS)~     and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System -~     Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for~     resection of the primary tumour will be compared to those that are unable to have surgery.~     Data collected from this questionnaire can highlight the benefits in patients' QoL who~     receive palliative surgical resection, and whether these benefits surmount those who are not~     treated with palliative surgery.~   "
74598|NCT02080884|"~     This study will examine the effectiveness of MabThera therapy added to a standard~     chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia~     (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are~     eligible. The overall response rate of patients treated for approximately 5 months (as per~     current label guidelines) will be analysed according to various factors (i.e., age,~     concurrent treatment, and chromosomal abnormalities).~   "
74599|NCT02080858|"~     Background:~      The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and~     associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic acid (ASA)~     with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the treatment of~     patients with advanced CAD. Due to delayed onset of action, intersubject variability or~     resistance to clopidogrel, different platelet aggregation inhibitors have been developed.~     Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy compared to~     clopidogrel in the prevention of cardiovascular death in these patients.~      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial~     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in~     patients with AF, the direct factor Xa inhibitor apixaban has recently received approval for~     prophylactic treatment of patients with non-valvular AF.~      However, there is a lack of efficacy or safety data for the combined impact of~     antithrombotic drugs in patients requiring arterial and venous thromboembolic prophylaxis~     due to their underlying co-morbidities. One trial suggests treatment with VKA + clopidogrel~     without ASA as equal effective as antithrombotic triple therapy (with ASA) in this~     population. However, the effect in combination with novel oral anticoagulants has not been~     investigated so far.~      Study objectives:~      To evaluate the effect of ticagrelor + apixaban in combination with or without ASA at steady~     state on markers of coagulation activation and on thrombus size in an ex vivo perfusion~     chamber experiment. Additionally, plasma samples will be analysed for PK-data (ticagrelor &~     apixaban concentrations)~      Study design:~      A single-centre, prospective, sequential, controlled, analyst-blinded study in two groups.~     Subjects will receive ticagrelor + apixaban in combination with (study A) or without (study~     B) ASA. All IMPs will be administered at doses indicated for stroke prevention in AF (lower~     dose: 2.5mg due to ethical concerns) or ACS. Markers on thrombin generation and platelet~     activation will be studied in venous blood where coagulation is in resting state and in shed~     blood where the clotting system is activated in the microvasculature in vivo: prothrombin~     fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), β-thromboglobulin (β-TG). Additionally,~     inhibition of factor Xa activity and concentrations of ticagrelor and apixaban will be~     assessed in venous blood. Further, thrombus size of clots formed in an ex vivo perfusion~     chamber will be determined by measurement of D-Dimer and p-Selectin levels.~      Study population A total of 40 healthy, non-smoking and drug-free male volunteers will be~     enrolled (study A and B; n = 20 per group).~      Main outcome variables:~        -  β-TG in shed blood~      Additional outcome variables:~        -  F1+2 and TAT in shed blood~        -  fibrin formation (D-Dimer) and platelet deposition (p-Selectin) in an ex vivo perfusion~          chamber model of thrombosis~        -  β-TG, F1+2, TAT & inhibition of factor Xa in venous blood~        -  PT, aPTT and ACT in venous blood~        -  ticagrelor & apixaban plasma concentrations~        -  shed blood volume~   "
74600|NCT02080845|"~     The Hershey Company is interested in investigating the effects of various chocolate~     beverages on brain physiology and cognitive function. The main substances in the drinks that~     are known to influence the brain are caffeine and related chemicals such as theobromine.~     Caffeine and chemicals related to caffeine are all naturally occurring and all potentially~     alter brain physiology. This study will evaluate changes in brain blood flow and cognition~     following the consumption of drinks with various combinations of the Primary Ingredients.~     The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design~     in an attempt to understand the differential effects of these compounds in chocolate drinks.~   "
74601|NCT02080832|"~     The purpose of this study is to examine the role of brain MRI findings in predicting~     treatment outcomes among individuals with cocaine dependence.~   "
74602|NCT02080819|"~     This project proposes to investigate the role of brain connectivity in the mechanism of~     treatment response to dopaminergic medications in cocaine dependence.~   "
74603|NCT02080806|"~     Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough~     response. This pilot study was performed to determine if Mechanical Insufflation~     Exsufflation (MIE) therapy can help recover impaired cough function.~   "
74604|NCT02080793|"~     This study will be based on two questionnaires~        1. One specific questionnaire that has already been developed from social sciences~          interviews conducted in men who have been treated for localized prostrate cancer, with~          a good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios.~          Each scenario gathers in a random manner, the modalities of 7 possible characteristics~          of the management strategy for localized prostrate cancer, with a good or intermediate~          prognosis:~             -  the risk of death at 5 years (modalities: 5%, 15%),~             -  the risk of impotence (modalities: 0%, 25%, 50%, 75%),~             -  the presence of urinary leaks (modalities: no protection during the day, one~               protection pad per day, several protection pads per day),~             -  the duration and frequency of care provided (modalities: 2 days of care in your~               whole life, 7 days of care in your whole life, 5 half-days of care per week for 8~               weeks, every 3 months for 2 years then every 6 months for life),~             -  ablation of the prostate (modalities: Yes, No),~             -  the existence of possible treatments in case of aggravation or recurrence~               (modalities: Yes, No),~             -  the nature of the technology used (modalities: innovative technology, standard~               technology).~           The objective is to ask each participant of the study for each pair of scenarios, to~          choose from the two scenarios (binary-choice survey), the scenario he prefers.~        2. The Spielberger Inventory Trait scale to evaluate stable characteristics in the~          propensity to anxiety in study participants.~   "
74605|NCT02080780|"~     The purpose of this study is to evaluate the drug-drug interaction potential of~     clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.~   "
74606|NCT02080767|"~     The purpose of this clinical protocol is to treat individuals with Tecovirimat after~     exposure to orthopox viruses.~   "
74607|NCT02080754|"~     Lung aspiration can occur when a rapid sequence induction of anesthesia is performed~     (emergency and/or presence of at least one risk factor for regurgitation of stomach~     contents).~      The aim of this study is to assess the Sellick maneuver, which is recommended for patient at~     high risk of aspiration of gastric content during induction of general anesthesia, despite~     the lack of solid evidence of its efficacy and possible adverse effects The primary outcome~     of this non inferiority study is the incidence of lung aspiration whether this maneuver is~     effectively applied or sham.~   "
74647|NCT02080234|"~     To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase~     (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed~     stage IE/IIE ENKTL.~   "
74608|NCT02080741|"~     This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of~     50 patients according to their behaviour type, and their adaptation to different factors of~     stress encountered in their lives:~        -  the first group will consist of patients with a characteristic Type A behaviour~          profile, that is to say patients with a proactive, impatient behaviour pattern~        -  the second group will consist of patients with a characteristic Type B behaviour~          profile that is to say patients with a calm, slow behaviour pattern The objective is~          to know if the different behaviour patterns are associated with distinct biological~          markers likely to influence the evolution of the diabetes.~      Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:~        1. they will answer simple questions about their disease and then complete 3~          questionnaires each with 14 items.~        2. they will meet a clinical psychologist for an interview lasting approximately 45~          minutes recorded on an audio recorder. The consultation will be used to seek links~          between the psyche and the disease.~        3. they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the~          morning.~   "
74609|NCT02080728|"~     The surgeon places the catheter in the thickness of the oblique internal and transverse~     muscles at the moment the wall is closed, under visual control. A multiperforated catheter~     whose length corresponds to that of the incision is chosed. The catheter will deliver one of~     two products chosen at random: either ropivacaine or placebo.~      This study will evaluate postoperative pain during the first 24 hours thanks to a recognized~     indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will~     also be recorded, starting with the titration of morphine in the post-op room, and then the~     consumption of classical analgesics in the nephrology department. These will only be given~     if the VAS score is equal to 4 or above.~      This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2%~     versus placebo in continuous TAP block during the first 24 hours after the operation in~     patients undergoing kidney transplant surgery.~   "
74610|NCT02080715|"~     In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy~     subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects~     are identified by measurement of vigilance and cognitive performance as well as EEG~     measurements during wake and sleep.~        -  Trial with medicinal product~   "
74611|NCT02080702|"~     The aim of this non-interventional study is to evaluate the efficacy of a monofilament,~     mid-term absorbable suture material (Monosyn®) for anastomosis performed in the~     gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.~      Postoperative complication rate, length of hospital stay, costs, time to perform the~     anastomosis and handling will serve as secondary endpoints.~      The question is addressed, whether a monofilament suture material is as effective as a~     braided suture material for anastomosis construction within the gastrointestinal tract.~   "
74612|NCT02080689|"~     The influence of Decipher test on urologist and patient treatment plan choices immediately~     post RP and at the time of PSA rise or BCR~   "
74613|NCT02080676|"~     Purpose of study: to check the effect of medical cannabis given for approved medical~     indications on ocular parameters including intra ocular pressure, optic nerve fibers~     thickness and choroidal thickness.~   "
74614|NCT02080663|"~     In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and~     triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure~     converts the wrist in a simple hinged joint but allows us to preserve a certain range of~     motion in the wrist. One of the main disadvantages of PRC is the risk of developing~     arthritis between the head of the capitate and the lunate fossa. The long-term follow-up of~     this procedure has always been a reason for concern. The investigators set up this~     retrospective study to evaluate the long-term results of the procedure in the investigators~     institution.~      Also, the shape of the head of the capitate may play a role in the development of arthritis.~     A more round shape could distribute the forces more equally and thus prevent the progression~     of cartilage damage~      The study hypothesis is:~        -  PRC preserves range of motion and force in the long term (more than 10 years~          postoperatively).~        -  A more round head of the capitate is associated with an increased risk of developing~          arthritis in the new joint.~   "
74615|NCT02080650|"~     This pilot study will aim to determine whether circulating tumor cells (CTCs) can be~     captured using the novel cMET based ferrofluid. The primary objective of this pilot study~     will be to describe the numbers of c-MET expressing cells that can be detected by the c-MET~     CTC capture technique. These data will be separated by disease site. The investigator will~     also describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture~     techniques in each patient, also separated by disease site.~   "
74616|NCT02080637|"~     Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of~     ambrisentan after Fontan surgical palliation of single ventricle heart defects.~      Study activities and population group: Children undergoing Fontan surgical palliation for~     single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled~     (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on~     post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will~     be obtained at specified time points during treatment. Post-operative monitoring lines will~     be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic~     endothelial function.~   "
74617|NCT02080624|"~     Sturge-Weber syndrome (SWS) is a rare congenital neuro-cutaneous disorder considered as a~     rare or orphan disease. SWS is characterized by a capillary vascular malformation (CM)~     localized on the skin of the face, eyes and central nervous system. Given the localization~     and the extent of the CM, children with SWS are particularly prone to developing severe~     psychological problems. The standard treatment for CM is pulsed dye laser (PDL) although in~     these cases whitening of the lesion is rarely achieved. Combining topical rapamycin, a~     specific inhibitor of the mammalian target of rapamycin, with PDL is hypothesised to be a~     good therapeutic option in these patients.~   "
74672|NCT02079909|"~     The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and~     ADCS-CGIC.~      The secondary objectives are:~        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety~          laboratories, physical examinations, ECGs and solicitation of adverse events.~        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric~          Inventory (NPI) and Mini-mental State Examination (MMSE).~   "
74618|NCT02080611|"~     The investigators hypothesize that a garment-integrated sensing system will be able to~     detect with clinical accuracy the position of the spine. The investigator will evaluate this~     using healthy adult volunteers, who will don sensing garments and assume a series of spinal~     postures. Concurrent with garment sensing, the participant's spine position will be measured~     using a motion-capture system that uses reflective markers to detect positions of markers in~     3D space.~      The motion-capture system provides a gold-standard reference measure to which the sensing~     garments will be compared. Because the investigators are evaluating the accuracy of the~     sensing garment, it is only necessary that the investigator test the garments on~     participants with subtly different body shapes. Healthy adult volunteers provide an adequate~     input to the sensing signal.~   "
74619|NCT02080598|"~     The aims of this cross over prospective study are to demonstrate that smoking two cigarettes~     do not change the gastric contents and volume in fasting volunteers.~   "
74620|NCT02080585|"~     The present study used a cluster-randomized controlled trial to evaluate the effects of a~     computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the~     Internet. An invitation e-mail with study information was sent to managers of 18~     white-collar workplaces. Eight workplaces consented to participate. All employees of a~     single workplace were allocated at random to either the intervention or a waiting list~     control group, in order to avoid contamination between employees receiving the intervention~     and those who were not receiving the intervention. Subsequently, employees of the~     participating workplaces were recruited by e-mail. Only Dutch speaking employees between 18~     and 65 years old, who had access to the Internet at work or at home, were eligible.~     Interested employees could sign up by returning a confirmation e-mail to the researchers. On~     receiving this information, a meeting was organized in each of the eight worksites to~     deliver all documents for baseline measurement (T0) to the participants, including an~     informed consent form, a blinded pedometer, an activity log and a self-administered~     questionnaire. During this meeting, information was provided on how to use the pedometer,~     how to log PA activities and how to answer the questionnaire. Moreover, the participants~     were asked to adhere to their usual PA pattern throughout the baseline measurement. After~     one week, all measurement tools were collected, and average daily step counts were~     calculated. At this point, participants in the intervention condition received (1) a booklet~     with information on how to increase steps, (2) a non-blinded pedometer, which they could use~     for three months, and (3) a username, a password and the amount of average daily steps,~     calculated by the researchers, so that participants could use this number when requesting~     the online computer-tailored step advice. Participants in the control condition did not~     receive any of the above mentioned intervention components. One and three months later, all~     participants again received a blinded pedometer, which was worn for one week. When wearing~     the blinded-pedometer one month (T1) and three months (T2) post baseline, intervention~     participants were allowed to also were the non-blinded pedometer. Furthermore, the same~     self-reported questionnaire was used to measure PA level at T1 and T2 in order to test the~     effectiveness of the intervention.~   "
74621|NCT02080572|"~     Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function,~     which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable~     movement sensors could be used to assess gait impairment in the patient's home hours after~     treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the~     effects of turning off deep brain stimulation on lower extremity and gait function over~     three hours. This study will provide vital information about our patient worn system's~     ability to detect changes in lower impairment over time, which could be used to assist with~     DBS tuning for the lower extremities and gait in the future.~   "
74622|NCT02080559|"~     This randomised, open-label, single-centre, descriptive study aims to investigate gene~     expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB~     and to relate this to vaccine reactions and to immune response.~      160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet~     received their routine infant immunisations will be recruited. Participation in the study~     will be limited to to Caucasian infants (defined as having two Caucasian parents). This is~     so that baseline variability in gene expression data which is to some degree affected by~     ethnicity is reduced.~      Participants will be randomised to either a 'test' group or 'control' group depending on~     what 4CMenB schedule they receive, with 80 infants in each.~      All participants will receive the usual paediatric immunisations according to the UK~     national immunisation schedule. In addition, participants in the test groups will receive~     4CMenB at 2, 4 and at 12 months while those in the control groups will receive the same~     vaccine at 5, 7 and 13 months. Blood samples will be taken from each infant at specified~     time points before and after vaccination to address the objectives of the study.~      In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to~     investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.~   "
74623|NCT02080546|"~     Purpose of this randomized control study is to determine if the mode of electrothermal~     colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic~     hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff~     healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V~     mode or standard cut/coag form of electrothermal energy.~      Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be~     used to examine the association fo dehiscence with proposed risk factors in the~     retrospective part of the study. In the randomized controlled trial, depth of thermal injury~     will be compared between the two groups, and a chi-square test will be used to test for a~     difference in clinical outcomes between the two groups. There is little risk associated with~     this study above the normal surgical risks; however, the V mode has not been previously been~     studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the~     study, but all samples will be de-identified and given a unique study number, and only~     individuals directly involved in the study will be given access to the study information.~   "
74632|NCT02080429|"~     Obesity rates in reproductive aged women in the United States are rising. It is now~     universally accepted that obesity is associated with many adverse pregnancy outcomes and~     post-operative complications following cesarean section. Recent studies have also shown an~     increased rate of cesarean section in obese women, adding to the already elevated rate of~     complications and adverse outcomes. Given the increased a priori risk for obese patients, it~     is vital that the investigators reexamine management practices routinely used for normal~     weight women in this specific high-risk population. Passive descent has been shown to~     increase the spontaneous vaginal delivery rate in non-obese women; however, high quality~     studies have never been performed in obese women. the investigators hypothesize that passive~     descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with~     regional anesthesia. This study will randomize women to passive descent for ninety minutes~     or active pushing upon entry into the second stage. Further, given that passive descent is~     widely accepted in the midwifery literature and clinical practice, the investigators~     anticipate that a high-quality study in the physician literature could increase the dialogue~     between practitioners and lead to development of best practices in this high-risk~     population.~   "
74624|NCT02080533|"~     Pulmonary arterial hypertension (PAH) is a chronic illness characterized by increased~     pulmonary pressures resulting in right heart failure and premature death. Common symptoms~     that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. This~     trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that~     co-occur) in PAH. From a biological, proinflammatory cytokines are implicated in dyspnea,~     fatigue and sleep disturbance; there is activation of the sympathetic nervous system (SNS)~     and an inherent inflammatory process in PAH that contributes to the pathophysiology, but the~     link to this symptom cluster has not been investigated. One novel, treatment for symptom~     clusters is slow-paced respiration therapy using the FDA-approved device, RESPeRATE. The~     device contains headphones and a sensor that attaches to the chest to detect inhalation and~     exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to~     decrease respirations. RESPeRATE moderates effects of the SNS; lowers blood pressure;~     improves functional capacity and ejection fraction; and significantly decreases pulmonary~     pressures in left heart failure. The investigators will enroll 10 women with PAH to use the~     RESPeRATE device to perform slow-paced respiration for 15 minutes per day for 8 weeks to~     determine the feasibility and effects on the SNS and inflammatory activity and the symptom~     cluster. The investigator's overall hypothesis is that, as compared to baseline, after eight~     weeks of therapy women with PAH who receive slow-based respiration therapy will have lower~     SNS activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.~   "
74625|NCT02080520|"~     The potential for nattokinase to thin blood and to reduce blood clotting by positive~     antithrombotic and fibrinolytic effects presents a unique opportunity to safely study such~     effects on cardiovascular disease and cognition. Unfortunately, such studies of~     antithrombotic and fibrinolytic pathways of prevention have been limited due to lack of safe~     compounds and the adverse reactions associated with current agents such as Coumadin.~     Nattokinase, an over-the-counter supplement used for cardiovascular health, is the most~     active functional constituent of natto, a fermented soy product. Natto has been consumed~     primarily by the Japanese for over 1000 years, a population with one of the lowest risks for~     cardiovascular disease and dementia. Cardiovascular disease and dementia remain the most~     challenging age-related health risks of the 21st century for Americans necessitating~     development of further effective preemptive strategies. Whether reducing the propensity for~     thrombus formation and/or increasing fibrinolytic activity can prevent the progression of~     atherosclerosis and cognitive decline has not yet been determined.~      Using nattokinase under primary prevention conditions, the investigators propose to conduct~     a randomized, double-blinded, placebo-controlled trial to determine whether decreasing~     atherothrombotic risk can reduce the progression of atherosclerosis and cognitive decline.~     The investigators propose to randomize 240 healthy non-demented women and men to nattokinase~     supplementation or to placebo for three years. The primary trial end points will be~     measurement of carotid arterial wall thickness and arterial stiffness, early changes of~     atherosclerosis that can be measured safely by non-invasive imaging techniques. The~     secondary trial end point will be ascertained through change in cognition measured by a~     neuropsychological battery. In addition, biochemical blood measurements and in vitro studies~     will be conducted to compare the effects of nattokinase relative to placebo on blood~     coagulation and thrombus break-down capabilities, blood flow properties, inflammation and~     inflammatory activation of endothelial cells that line blood vessels.~      At the conclusion of this trial, the investigators expect to have sufficient evidence as to~     whether reducing the propensity for thrombus formation and/or increasing fibrinolytic~     activity can prevent the progression of atherosclerosis and cognitive decline. These results~     will provide novel and important data that will be informative concerning primary prevention~     through the atherothrombotic pathway. Providing evidence for a reduction in atherosclerosis~     progression and cognitive decline with nattokinase is likely to shift the current clinical~     paradigm for the prevention of these chronic age-related processes. In addition, such~     evidence will serve to create a new field of discovery and opportunity for prevention of~     cardiovascular disease and dementia.~   "
74626|NCT02080507|"~     The purpose of this study is to determine the safety and efficacy of rTMS as an alternative~     treatment to ECT. The study will also provide data for a power analysis to support a larger~     clinical trial if there is evidence of a clinically relevant treatment effect.~   "
74627|NCT02080494|"~     Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative~     blood loss. This study is a prospective, randomized controlled trial investigating the use~     of tranexamic acid in fracture surgery around the hip and knee, in which significant blood~     loss (>300mL) is expected.~      The hypothesis of this study is that tranexamic acid will be associated with a decrease in~     post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in~     patients who have fracture surgery around the hip and knee.~   "
74628|NCT02080481|"~     An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been~     recently developed to guide clinicians in performing ultrasound guided nerve blocks. This~     system helps the clinician to align the needle with ultrasound beam while performing an~     ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing~     efficient needle movement while having improved needle shaft and tip visualization. This is~     a disposable system specifically designed for improving success rate of ultrasound guided~     block and patient safety.~      This study will be done with patients having elective knee surgery and a femoral nerve block~     with a catheter. The nerve block procedure will be performed under ultrasound guidance to~     help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently~     developed to try to improve needle guidance in the ultrasound guided nerve block procedure.~     This study will determine whether femoral nerve block procedures performed under ultrasound~     guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound~     guidance and a conventional block needle. The study will also determine whether the~     InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure,~     reduces the cost of the procedure, increases the procedure success rate, and improves~     ultrasound visibility of the needle.~      Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus~     (TM) needle guidance system or ultrasound guidance with a conventional block needle. After~     surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while~     awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain~     treatment satisfaction and a questionnaire about recovery.~   "
74629|NCT02080468|"~     The primary objective of this study is to assess the effect of ethinyl estradiol~     (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK)~     of lomitapide and 2 primary metabolites, M1 and M3.~   "
74630|NCT02080455|"~     The primary objective of this study is to assess the effect of atorvastatin, a weak~     cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2~     primary metabolites, M1 and M3.~   "
74631|NCT02080442|"~     The study will involve direct knowledge translation of a laboratory-based study of balance~     training for patients with COPD, first to the investigators PR program and then, after~     disseminating the results, this approach could be used to impact on clinical practice in any~     PR program.~   "
74633|NCT02080416|"~     The goals of this study is to determine if nelfinavir can target Epstein-Barr virus (EBV)~     and Kaposi sarcoma-associated herpesvirus (KSHV) in patients with certain cancers.~   "
74636|NCT02080377|"~     The aim of this open label feasibility study is to determine recruitment rates to a~     randomised trial of glibenclamide compared with insulin (both in addition to maximum~     tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This~     feasibility trial will inform the design of a future substantive multicentre trial to test~     the hypothesis that combination therapy with glibenclamide and metformin could reduce the~     number of pregnant women with GDM who require insulin and would be superior to metformin and~     insulin in terms of acceptability and cost effectiveness.~      Women with GDM who have failed monotherapy with metformin will be recruited and randomised~     to either receive glibenclamide (test arm) or standard care with insulin, both in addition~     to their maximum tolerated dose of metformin. Patients will be recruited from three of the~     antenatal clinics.~      This is a feasibility study in preparation for a large multicentre randomised trial to test~     the hypothesis that the addition of glibenclamide to metformin (combination therapy) could~     reduce the number of pregnant women with gestational diabetes mellitus requiring insulin,~     without compromising glycaemic control or other clinical outcomes. The investigators~     hypothesise that combination therapy with metformin and glibenclamide is likely to be~     preferable to metformin and insulin in terms of acceptability and cost.~   "
74637|NCT02080364|"~     This is a study to evaluate the efficacy and safety of azeliragon in patients with mild~     Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's~     participation lasting approximately 18 months.~   "
74638|NCT02080351|"~     This research study is designed to investigate the effects of a simple cognitive task (a~     memory reactivation cue following by playing the computer game Tetris) on flashbacks and~     other post-traumatic stress symptoms after a road traffic accident. Patients presenting to a~     hospital emergency department soon after a road traffic accident will be randomly allocated~     to either the simple cognitive task intervention or usual care. Participants will be~     followed up at one week and one month. It is predicted that participants given the simple~     cognitive task intervention will develop fewer flashbacks and less severe clinical symptoms~     than those who are not. This will inform the potential future development of a simple~     technique to prevent distressing psychological symptoms after a traumatic event.~   "
74639|NCT02080338|"~     The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems~     to determine which is more effective for orthodontic treatment .~   "
74640|NCT02080325|"~     This study aims to investigate the mechanistic processes involved in protein-induced~     satiety/satiation during weight loss in humans.~      Thsi study will investigate:~        -  How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources~          impact on profile of 'motivation to eat' both within a day and between days ?~        -  Do biomarkers of satiety alter differentially on meat or soya HPWL diet, as measured by~          monitoring alteration in plasma amino acids and gut-related hormones ?~        -  How does a vegetarian and meat-based weight loss diet impact on nitrosamine excretion~          in faecal samples, as an indicator of faecal toxicity?~      Previous work has indicated that high-protein (30% protein) weight loss diets are more~     satiating (produce less hunger) than normal protein WL diet (15% protein) or a diet~     supplemented with few amino acids. In previous work, a mixed source of protein has been~     used, mainly from meat (beef, chicken, fish). These types of diets have been criticised~     because of the potential negative side effects, including our own work on gut health. It~     might be that alternative vegetable sources of protein could fulfil the diet remit, to be~     satiating and yet still allow weight loss, and maintain a healthy gut.~      Design -within subject, randomised cross-over design after day 3. Each subject acts as their~     own control and will receive each treatment. 18-20 subjects to participate.~      Length of time - Conduct the two nutritional interventions over a period of 14 days, in~     order to reduce effects due to an acute change in nutritional intake.~      PROTOCOL Days 1- 3 - Normal Protein Maintenance diet (NP- MTD, 3 days)~        1. st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),~        2. nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),~   "
74641|NCT02080312|"~     This is a pilot study of patients with clinical symptoms of Ménière's disease using~     injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to~     evaluate inner ear structures.~      The goal is to reproduce imaging findings described by non-United States (US) institutions,~     improve on image quality with decreased scan time and evaluate the dynamics of the contrast~     movement into the inner ear structures.~   "
74642|NCT02080299|"~     Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical~     practice, but concerns have been raised regarding periprocedural complications like e.g.~     myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC)~     with upper limb ischemia/reperfusion provides perioperative myocardial protection in~     patients undergoing elective coronary artery bypass surgery. The present study assesses~     protection of heart, brain and kidney by RIPC in patients undergoing TAVI. The study also~     addresses safety and clinical outcome.~   "
74643|NCT02080286|"~     The present study aims to compare the relative therapeutic efficacy of prism adaptation~     therapy combined with real versus sham tDCS. The investigators will test the hypothesis that~     the magnitude and duration of neglect improvement will be increased when prism therapy is~     combined with real tDCS compared to sham tDCS.~      A second objective is to test whether individual differences in baseline clinical or brain~     imaging measures can predict: 1) neglect severity or 2) inter-individual differences in~     patients' therapeutic response.~      A third goal is to use brain imaging to characterize the patterns of neural change induced~     by the intervention to identify brain structures that mediate therapeutic response.~   "
74644|NCT02080273|"~     The objective of this randomized, single center, parallel clinical research study is to~     evaluate the comparative efficacy performance of three dentifrices -Colgate Total~     Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling~     gingivitis and dental plaque in adults.~   "
74645|NCT02080260|"~     This study tests regorafenib as a single agent in the treatment of metastatic pancreatic~     cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis~     for these patients is particularly grim, no other standard treatment options exist, and~     novel approaches are desperately needed.~   "
74646|NCT02080247|"~     A randomized controlled trial that compared the use of two topical zinc oxide based diaper~     rash products in a structured care regimen for the treatment of IAD in hospitalized adults~     and older children.~   "
74648|NCT02080221|"~     A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved~     chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you~     will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and~     Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®.~     Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with~     the other 3 drugs is being investigated. Your doctors are studying the activity and side~     effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.~   "
74649|NCT02080208|"~     Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who~     need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as~     in respiratory weaning. Now new devices can be used. They provide high flow oxygen with~     different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2),~     allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of~     this study is that the high flow oxygen enable more efficient oxygen administration than~     conventional oxygen. In addition, it would improve the effectiveness of the ventilation of~     the patient, through flushing the dead space.~   "
74650|NCT02080195|"~     The main goal of the study is to determine if bone marrow transplant (BMT) from a less~     specific pool of donors in combination with high dose cyclophosphamide can induce remission~     of refractory systemic lupus erythematosus.~   "
74651|NCT02080182|"~     In different studies, it has been shown that antioxidant utilization has favorable~     therapeutic effects not only on control of acute symptoms but also on prevention of delayed~     problems from acute and chronic pyelonephritis.~      According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and~     side effects of similar or either less than placebo, this study was designed to evaluate the~     efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a~     triple-blind placebo controlled study on a population of 64 patients 1-16 years old that~     have definite or probable diagnosis of acute pyelonephritis in Mofid hospital.~      After randomization, patients will be given acetylcysteine or placebo with dosing according~     to their weight. Results of treatment are evaluated according to serum procalcitonin, C~     reactive protein and leukocyte count before drug prescription (baseline) and 5 days after~     drug prescription. Side effects are also recorded in both groups. Patients will be receiving~     their routine antimicrobial drugs in addition to acetylcysteine.~   "
74652|NCT02080169|"~     It is well known that ICU patients need sedation. Now no ideal sedation drug existed and~     every sedation drug has its advantage and disadvantage,so combined sedation may use the~     advantage and avoid the disadvantage of the sedation drug according to the~     patients'condition. Until now, there is rare study about the combined sedation or sequenced~     sedation of different sedation drug.The purpose of the study is to explore the value of~     combined sedation with midazolam and dexmedetomidine compared to single drug sedation in~     ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain~     the appropriate sedation not under sedation or over sedation,reduce the incidence of~     delirium, reduce the adverse event of sedation.~   "
74653|NCT02080156|"~     Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the~     mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea~     (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass~     grafting (CABA) during postoperative follow-up of 3 years.~   "
74654|NCT02080143|"~     A disposable, air-activated, adhesive backed heat patch is being evaluated.~   "
74655|NCT02080130|"~     The purpose of this study is to determine which of two different preparations of probiotics~     is effective in the treatment of acute viral diarrhoea in children.~   "
74656|NCT02080117|"~     It is required to establish an adequate definition of delayed graft function in deceased~     donor kidney transplantation. We attempt to compare various definitions of delayed graft~     function and find the definition that can predict graft function survival best in deceased~     donor kidney transplantation.~   "
74657|NCT02080104|"~     Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour~     following vaginal delivery: A randomised controlled trial~   "
74658|NCT02080091|"~     This observational study aims to assess the safety and effect of Iluvien® in DME patients~     considered insufficiently responsive to available therapies in a real life setting in~     Germany.~   "
74659|NCT02080078|"~     This study is to determine the use of theophylline in patients with NSCLC and advanced solid~     malignancies and whether treatment with theophylline will help lower or diminish the side~     effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two~     parts of the study to verify the lowest dose of theophylline that is effective and the~     highest dose of erlotinib that can be tolerated with theophylline. If this study shows that~     theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that~     patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at~     higher doses without experiencing severe diarrhea.~   "
74660|NCT02080065|"~     The incidence of acute kidney injury after liver transplantation has been reported to be 17~     to 95 percent, but no definite treatment has been reported yet. Therefore, it is important~     to identify and prevent reversible risk factors for acute kidney injury after liver~     transplantation. Previous studies have reported several preoperative clinical risk factors,~     but preoperative medication and intraoperative colloid administration and hemodynamic~     parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk~     factors and develop simplified clinical risk scoring model.~   "
74685|NCT02079740|"~     This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax~     in treating patients with solid tumors that have spread to other places in the body or~     cannot be cured or controlled with treatment. Trametinib and navitoclax may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
74686|NCT02079727|"~     The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6~     sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee~     osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as~     active comparator.~   "
74687|NCT02079714|"~     The STREAM Study is a prospective longitudinal observational outcomes study that will~     examine the reliability, validity and responsiveness of the PROMIS tools for clinical~     research following orthopaedic trauma.~   "
74661|NCT02080052|"~     Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance~     (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the~     procedure has high false-negative rates. This represents a daily problem for urologists~     managing the disease, creates uncertainty and emotional stress for patients, and initiates a~     cascade of repeat testing and biopsies which also burden the investigators healthcare~     system.~      The investigators believe that prostate biopsy can be improved by using a new biopsy~     paradigm. The investigators plan to perform MRI-guided prostate biopsies with~     robot-assistance for orienting a needle-guide through which the biopsy is taken. The~     combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity~     compared to regular TRUS biopsies.~      The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and~     safety. The needle-guide robot is an investigational device developed in their Urology~     Robotics Laboratory.~   "
74662|NCT02080039|"~     In this study the following hypotheses will be tested:~      Electrical stimulation of the gluteal muscle (buttocks) leads to~        1. an increase in the thickness of the gluteal muscle~        2. a decrease in the thickness of the fat of the buttock area~        3. a change in the distribution of the middle and maximal seating pressure to a more~          consistent pressure~        4. an increase in well-being of the patients.~   "
74663|NCT02080026|"~     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious~     diseases. With approximately 627.000 deaths a year, there is desperate need for an effective~     vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve~     the level of efficacy necessary to eliminate malaria. It has been shown previously that~     healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine,~     medicine that prevents malaria, are fully protected against a subsequent malaria challenge.~     This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes~     it a good model to identify what immune responses protect against malaria, to further guide~     vaccine development. In this study we will use CPS-immunization to induce protection against~     malaria in healthy subjects and then analyse their immune response to a malaria challenge~     infection.~   "
74664|NCT02080013|"~     our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized~     study.~   "
74665|NCT02080000|"~     The aim of this study is to investigate whether the use of a simple feature on the 12 lead~     electrocardiogram (ECG) to optimise pacemaker device programming can have clinically~     relevant benefit to patient management. More specifically it is to investigate whether using~     the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right~     ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.~   "
74666|NCT02079987|"~     The purpose of this study is to find out if a new way of helping patients after they leave~     the Emergency Room (ER) improves their quality of life. The purpose is also to find out if~     the new way of helping decreases ER use.~   "
74667|NCT02079974|"~     Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with~     intercourse and infertility. The available treatment options to alleviate pain involve~     mainly hormonal treatments and surgery. All current hormonal treatments are effective but~     disrupt the normal variations in reproductive hormones which prevent ovulation, and thus~     pregnancy. Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties~     which may be helpful also for the pain related to endometriosis. The investigators plan to~     undertake a pilot study of 10 patients with endometriosis who will take pravastatin sodium~     together with coQ10, which is inhibited by statins, for a period of 3 months. If this pilot~     study shows that the statin treatment may decrease pain symptoms in endometriosis, then the~     investigators plan to undertake a larger study to further investigate this matter.~   "
74668|NCT02079961|"~     The study on dairy value chains that will be conducted in Northern Senegal tests whether a~     health-related product (micro-fortified yogurt) targeted to children can be provided through~     the logistics of an existing value chain, and whether in return this can be leveraged to~     enhance the reliability of producers supply within this value chain. This study is conducted~     with a local milk factory, a recently established social enterprise, striving to produce~     dairy products with the milk collected from several hundred semi-nomadic small-scale~     producers in northern Senegal. This study tests: (i) whether the logistic created to collect~     milk in a remote area can be leveraged to deliver fortified yogurts to infants within its~     suppliers households; (ii) whether such products effectively help improve the nutritional~     status (anemia) of these children; and (iii) whether these health services encourage~     suppliers (and in particular women) to increase their milk delivery to the milk factory.~   "
74669|NCT02079948|"~     This study will be the first to test whether a selected anti-inflammatory agent,~     methotrexate, reduces inflammation in a human body, improve cognitive and physical function,~     and reduce pain levels in older adults at risk for functional decline, due to systemic~     inflammation.~   "
74670|NCT02079935|"~     Eating disorders includes anorexia nervosa, bulimia nervosa, binge eating and other~     specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to~     control food intake, body image and body weight. Most people with this kind of disorder~     don't reach for professional help, or there may be more than 4 years before they do.~     Cognitive behavior therapy is the foremost method of treatment of eating disorders, but up~     to 30-50% of the patients don't respond to this. The investigators find it important to~     identify science based alternatives of therapy, as this may reduce the health concern, and~     broaden the choice of therapy methods. A former study by Sundgot-Borgen et al in 2002, found~     guided physical activity to reduce symptoms of bulimia nervosa just as good as the~     traditional cognitive therapy.~      The primary objective of the project is to see whether the combination of physical activity~     and nutritional education is more effective in treating eating disorders, than cognitive~     therapy.~      Secondly, the investigators want to see whether there are any differences with regard to the~     individual satisfaction of treatment method, and to associated costs.~   "
74671|NCT02079922|"~     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary~     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.~   "
74769|NCT02078648|"~     The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment~     for recurrent glioblastoma multiform (GBM).~   "
74673|NCT02079896|"~     Dialysis patients regularly suffer from anemia which may be caused by various contributing~     factors, alone or in combination, including blood loss, low erythropoietin and iron~     sequestration. In most patients, the anemia is responsive to treatment with erythropoietin~     or other erythropoiesis stimulating agents (ESA) alone or in combination with intravenous~     (i.v.) iron. In about 10% of patients however, the anaemia does not respond appropriately to~     this standard treatment and high to very high doses of ESA and i.v. iron are used to~     maintain acceptable hemoglobin concentrations. In these patients, hepcidin was identified as~     a causative factor leading to anemia of chronic disease with functional iron deficiency and~     ESA-hyporesponsiveness.~      The Spiegelmer lexaptepid pegol (NOX-H94) offers a hepcidin-specific approach to the~     treatment of anemia of chronic disease. The safety and the activity of lexaptepid pegol are~     supported by data from healthy subjects and patients with multiple myeloma or lymphoma. The~     present study in dialysis patients with functional iron deficiency and~     ESA-hyporesponsiveness is conducted to demonstrate the safety of lexaptepid pegol in this~     population, to investigate its pharmacokinetic (PK) and pharmacodynamic (PD) profiles and~     its efficacy in increasing haemoglobin (Hb) in dialysis patients.~   "
74674|NCT02079883|"~     This is a multicenter, prospective, observational, Phase 4 study that will assess clinical~     outcomes and safety of JETREA® administered in a real-world setting for the treatment of~     symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in~     1500 patients recruited across approximately 120 USA retina sites.~   "
74675|NCT02079870|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of~     semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride~     metabolism and gastric emptying in obese subjects compared with placebo.~   "
74676|NCT02079857|"~     The objective of this study is to test the efficacy of a symptom management treatment~     strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with~     Irritable Bowel Syndrome (IBS) in adults.~   "
74677|NCT02079844|"~     The purpose of this study is to determine whether cognitive impairment associated with~     schizophrenia is attenuated by add-on roflumilast administration to second generation~     antipsychotics (SGA) in participants with stable schizophrenia.~   "
74678|NCT02079831|"~     The aim of the proposed study is to provide important data on weight loss efficacy in~     overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein~     diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The~     investigators hypothesize that the higher protein diet will result in greater weight loss~     due to increased satiety and better dietary adherence.~   "
74679|NCT02079818|"~     The primary objective of this study is to gather post market data on the Penumbra Ruby Coil~     System in the treatment of visceral artery aneurysms and arteriovenous malformations. This~     study is a prospective, multi-center study of patients with visceral artery aneurysms and~     visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data~     for each patient are collected up to 12 months post-procedure for the study.~   "
74680|NCT02079805|"~     Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects~     of azilsartan (Azirva), compared with telmisartan, on insulin resistance in patients with~     essential hypertension complicated by type 2 diabetes mellitus~   "
74681|NCT02079792|"~     Chronic Rhinosinusitis (CRS) is a common disorder of the nose characterized by stuffy nose,~     discoloured nasal discharge, sinus congestion or pressure and decreased sense of smell,~     present for over twelve weeks. Anti-inflammatory steroid medication is often used to treat~     sinus inflammation in CRS. These steroids are sometimes delivered using a spray device that~     creates a mist to deliver steroid medication deep into the nose. However, the distribution~     and efficacy of sprayed medication can be affected by the position of the patient's head.~     This study aims to determine which of two head positions is best for delivering steroid to~     the sinuses.~   "
74682|NCT02079779|"~     Stroke is the principal cause of permanent disability within the investigators population.~     This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which~     can be optimized by robotics.~      The investigators team has developed a robot designed to rehabilitate the upper limb. This~     robot allows the patient to perform active, passive, or assisted exercises. The system is~     also able to assess movement quality and to provide a feedback to the patient and the~     therapist via a graphical interface. This therapy is designed to improve functional recovery~     of patients, and then their quality of life.~      Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at~     the acute stage of rehabilitation (< 3 months post stroke) when most improvements are~     observed.~      Thus, the aim of this study was to objectify the effectiveness of robotic-assisted~     rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF~     (International Classification of Functioning, Disability and Health) and performing a~     prospective multicenter randomized controlled single blind trial. In this study, 60 stroke~     patients will be recruited and randomized into two groups. All patients will receive a~     similar classical rehabilitation as a basis. Patients of the control and experimental groups~     will receive a supplement of classical rehabilitation and robotic-assisted therapy,~     respectively.~   "
74683|NCT02079766|"~     This study will explore the use of 18F-AV-1451 as a biomarker for chronic traumatic~     encephalopathy (CTE) and examine the relationship between clinical presentation and tau~     deposition.~   "
74684|NCT02079753|"~     Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study~     was designed to compare oxygen saturation and patient satisfaction with a portable oxygen~     concentrator or with a combined system consisting of a fixed device with continuous flow~     oxygen dispensation and a portable device with pulse dispensation for ambulation.~      Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4~     years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously~     used the combined system, consisting of a fixed oxygenation system and a portable system for~     ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a~     stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while~     walking were determined at baseline. Patients were maintained on the previous combined~     system for one week and then switched to the portable oxygen concentrator for one week. Mean~     SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was~     monitored~   "
74688|NCT02079701|"~     The primary objective is to determine the clinical benefit of employing the 23-valent~     pneumococcal vaccine among US military trainees. Secondary objectives include:~        -  determining the etiology of clinical pneumonia among U.S. military trainees;~        -  comparing the serotype distribution of S. pneumoniae (Sp) isolates recovered from~          vaccinated and nonvaccinated trainees diagnosed with pneumonia; and~        -  comparing days lost from training due to pneumonia or acute respiratory disease for~          vaccinated and nonvaccinated subjects.~   "
74689|NCT02079688|"~     Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder.~     Patients suffer from eczema and often severe pruritus on the affected skin, as well as from~     frequent complications and secondary infections. Next to a genetically predetermined defect~     in epidermal barrier function and vegetative dysfunction, AD arises from an upregulation of~     Th2-modified immune responses inducing increased IgE-antibody production, cytokine secretion~     and subsequently, local inflammation.~      Although standard therapies of AD, modern topical corticosteroids, show a better ratio of~     therapeutic effects to side effects, they retain a moderate acceptance due to their~     non-specific action, strict compliance requirements and possible adverse effects. As a newer~     alternative, calcineurin inhibitors show fewer side effects but raise concerns regarding~     long term risks including the possibility of skin carcinogenicity. Therefore, medical need~     remains for novel therapies for this major public health problem, directed in particular at~     specific early disease-causing mechanisms and/or molecular targets, with an improved~     efficacy, safety and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of AD.~      The transcription factor GATA-3 represents the key regulatory factor of Th2-driven immune~     responses. It is indispensable for the differentiation and activation of Th2 cells; it~     integrates Th2 signals and induces Th2 cytokine expression. The investigational product~     SB011 contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces~     specific cytokine production and thereby reduces key features of allergic airway~     inflammation.~      DNAzymes are completely generated by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or~     bacteria. The molecules are highly water-soluble and will be applied as a water/oil/water~     (W/O/W) formulation since multiple emulsions have been shown to protect the active~     ingredient from degradation on the skin and have penetration enhancing properties in~     comparison to other carrier systems.~      This proof-of-concept study will evaluate the efficacy, safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of the topical formulation SB011 containing~     2 % hgd40 twice daily (BID) in patients with mild to moderate atopic eczema.~   "
74690|NCT02079675|"~     The purpose of this study is to determine the efficacy and safety of different doses of~     SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome~     with non-constipation.~   "
74691|NCT02079662|"~     The goal of this behavioral research study is to look at the relationship between lifestyle~     factors and cancer-related outcomes, such as the risk of the disease coming back, patient~     quality of life, physical functioning, and bodily reactions (such as hormones and immune~     function).~   "
74692|NCT02079649|"~     The purpose of this study is to evaluate two investigational ophthalmic solutions for~     reduction in ocular redness in subjects with allergic conjunctivitis.~   "
74693|NCT02079636|"~     The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in~     combination with another anti-cancer drug in participants with NSCLC that is advanced or has~     spread to other parts of the body (stage IV). The study will also investigate how the body~     processes the combination treatment and how the study drug affects the body. The study will~     also collect disease-related symptoms and participant-reported pain related to NSCLC.~   "
74694|NCT02079623|"~     The aim for this study is to implement electroporation therapy (NanoKnife) treatment for~     patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will~     be given in addition to standard chemotherapy.~   "
74695|NCT02079610|"~     The purpose of this study is to determine whether upregulating the left amygdala during~     positive autobiographical memory recall via real time functional magnetic resonance imaging~     neurofeedback will lead to an improvement in clinician administered ratings of depressive~     symptoms. The investigators predict that patients with major depressive disorder receiving~     left amygdala neurofeedback will increase their amygdala response during positive~     autobiographical memory recall compared to those receiving control feedback from a region~     not involved in emotional processing and that this ability will be associated with~     clinically significant improvement.~   "
74696|NCT02079597|"~     -  With the underlying study the investigators address the question if Ninjurin-1 (Ninj1)~          expression is altered in patients with systemic inflammatory response syndrome (SIRS)~          in comparison to healthy volunteers.~        -  The adhesion molecule Ninj1 is induced following nerve injury where it contributes to~          nerve generation. Besides it is described to facilitate leukocyte migration especially~          in the nervous system.~        -  The investigators hypothesize that Ninj1 expression is increased in SIRS patients,~          which will fortify its impact during inflammation and the transferability from bench to~          bedside.~   "
74697|NCT02079584|"~     The objectives of this registry are to measure the outcomes, cost, adherence pattern and~     experience of patients treated as outpatients with rivaroxaban after being diagnosed with~     blood clots in the emergency department. The investigators hypothesize that patients will~     have a relatively low rate of adverse events and higher adherence than has been reported~     historically for warfarin treatment. Patients will be scheduled for follow up care with one~     of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital or Eskenazi Health~     Services after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis~     (DVT). The investigators will collect information for a registry and a database will be~     developed and blood specimens will be obtained at each follow up visit for analysis and~     storage for possible use related to this treatment and research or study at a later date.~     Questionnaires will be administered to collect variables that the investigators hypothesize~     to be important to understand the causes of non-adherence. To better quantify the economic~     impact, the investigators will also perform a cost effectiveness analysis with no~     comparator, meaning the investigators will tabulate the cost of care for each patient~     enrolled using variable costs from a UB92 report for each patient.~   "
74780|NCT02078505|"~     The polycystic ovary syndrome is intimately associated with body weight and nutrition.The~     genomic era did not bring a breakthrough to the understanding of the syndrome. The recent~     surge of studies on gut microbiome has raised the possibility that the specific diet, which~     often affect these women favorably, would change their gut microbiome. Hence, the~     investigators will examine their gut microbial population in comparison to normal ovulatory~     women and then examine whether a low carbohydrate diet causes favorable change in their gut~     microbial population.~   "
74781|NCT02078492|"~     Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in~     treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.~   "
74698|NCT02079571|"~     In traditional Chinese medicine (TCM), hot- and cold-attribute of food ingredients are a~     major part of dietary therapy. Eight Principles including cold/hot, repletion/vacuity,~     yin/yang and exterior/interior are used for diagnose by Chinese medical doctors. From the~     perspective of TCM, all constitutions, diseases, herbal medicine and foods can be divided~     into these two major categories, i.e., cold and hot. Therefore, dietary therapy claims that~     the attributes of foods should be used to oppose our constitutions in order to harmonize~     organ functions and maintain human vitality. The true benefit of dietary therapy is~     considered to be the reestablishment of a harmonious balance between cold and hot, or~     repletion and vacuity, within the human body.~      Previous studies reported that the capillary red blood cell (RBC) velocity in nail fold~     microcirculation (NFM) of the subjects with hot constitution accelerated significantly after~     taking the hot attribute aged ginger tea, which might be the result of elevated vagal~     activity leading to arteriole dilation in these subjects. In contrast, in subjects with cold~     constitution, capillary RBC velocity decelerated significantly and skin temperature~     decreased markedly after taking the cold-attribute coconut water, which might have been~     induced by sympathetic nerve activation causing the arteriole to be constricted. As a~     result, the use of capillary RBC velocity of NFM measured by laser Doppler anemometer may be~     a promising way to classify attributes of food ingredients commonly used in Chinese medicine~     dietary therapy in accordance with different personal constitutions.~      Accordingly, it will be a worthwhile task to establish a modern scientific methodology to~     define the attributes of food ingredients. The aim of this project is to investigate the~     relationship between food attributes and the physiological signals produced in healthy young~     subjects with different constitutions. In the first year of this project, investigators are~     starting to determine the pulse waves produced in healthy subjects with different~     constitutions by a Smart Pulse Wave Health Evaluation System (S-PULSE). Then, investigators~     will investigate the relationship between food attributes, channel entries and the~     physiological signals. Hopefully, the results will have a leverage on the powerful~     integration capacity within National Taiwan University (NTU) campus to build a hub for~     global TCM cloud.~   "
74699|NCT02079558|"~     Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of~     maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH~     would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin~     was compared in prevention of postpartum hemorrhage after cesarean sections.~   "
74700|NCT02079545|"~     The purpose of the study is to assess the bioavailability (the extent to which a medication~     becomes available to the body) of subcutaneously (under the skin using a needle)~     administered sirukumab and to compare the pharmacokinetics of sirukumab administered~     subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system~     (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.~   "
74701|NCT02079532|"~     This study will evaluate the efficacy and safety of MabThera in patients with active~     rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha~     inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous~     inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated~     with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate~     therapy. The anticipated time on study treatment is 2+ years, and the target sample size is~     100-500 individuals.~   "
74702|NCT02079519|"~     This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously~     every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines~     of prior therapy.~   "
74703|NCT02079506|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of candesartan and rosuvastatin each separately versus coadministration of candesartan and~     rosuvastatin in healthy male volunteers.~   "
74704|NCT02079493|"~     The purpose of this study is to obtain patient-oriented and clinically-oriented physical~     function outcomes both pre-operatively and post-operatively in patients receiving a total~     knee arthroplasty .~   "
74705|NCT02079480|"~     The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK)~     and pharmacodynamics (PD) of BMS-986090 in healthy subjects.~   "
74706|NCT02079467|"~     The purpose of this study is to determine whether the form of rehabilitation following~     primary total hip arthroplasty has an influence on patient satisfaction or functional~     performance in the eighteen weeks following surgery.~   "
74707|NCT02079454|"~     Research aimed to find a correlation with an invos drop and cardiac events in the~     peri-operative period of non cardiac surgery.~      The investigators postulate that a drop in the Invos numbers (with or without significant~     drop in BP) is associated with a variable degree of cardiac suffering.~      The idea is to prevent per and foremostpost-operative myocardial necrosis complications by~     acting as soon as we have an INVOS drop during anesthesia.~      The cardiac events will be monitored and defined according to the EHA (european heart~     association) guidelines.~      (Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored~     per and post operatively.~   "
74708|NCT02079441|"~     1. To evaluate the immune response to vaccines in infants of IBD patients treated with~          anti-TNF medications during pregnancy compared to infants of IBD mother not treated~          with anti-TNF medications.~        2. To evaluate the immune function of B and T cells at 3 months and one year of age in~          infants of IBD patients treated with anti-TNF medications during pregnancy compared to~          infants of non anti-TNF treated mothers.~      The secondary aims are to follow anti TNF drug levels in infants born to IBD patients~     treated with anti-TNF medications during pregnancy and to evaluate the risk of infections~     during the first year of life in this population, compared to children of IBD patients not~     treated with anti-TNF medications during pregnancy.~      Significance -The results of this study have the potential to change clinical practice of~     anti TNF treatment during pregnancy and the follow-up of infants born to these patients~   "
74709|NCT02079428|"~     The purpose of CN-HF is to establish the national registration of hospitalized heart failure~     patients, evaluate and compare the clinical features and prognosis of diastolic and systolic~     heart failure, and find out the status of treatment and implementation of guidelines on~     heart failure in China.~   "
74710|NCT02079415|"~     Saudi Arabia has been named by the International Diabetes Federation as among the top ten~     countries with highest prevalence of diabetes. Women are said to have overall prevalence~     twice that for men. With high birth rate in the country we decided to look at the impact of~     diabetic pregnancies on their off-springs~   "
74711|NCT02079402|"~     The purpose of this trial is to o assess feasibility of a protocol comparing conservative~     (trigger guided) vs. liberal (target guided) approach to fluid resuscitation in patients~     with septic shock after initial fluid resuscitation.~   "
74849|NCT02077608|"~     Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media~     and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer~     are incubated in a culture media containing high concentration of hyaluronan or low~     concentration of hyaluronan.~      Primary outcome: implantation and pregnancy rates~   "
74712|NCT02079389|"~     The following project deals with a Danish multicenter trial that evaluates the value of~     Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum~     cancer (CRC).~      The project The value of laparoscopic ultrasound in patients undergoing laparoscopic~     resection for colon and rectum cancer. - A prospective randomized trial is part of a ph.d-~     study at the University of Southern Denmark in collaboration with several surgical~     departments at hospitals in Southern Denmark.~      The primary purpose is to investigate whether the use of laparoscopic ultrasound examination~     (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the~     surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC).~      As a secondary objective; an evaluation of the use of LUS will change the treatment strategy~     for the individual patient with CRC.~      As an other objective we wants to investigate whether the use of contrast enhanced~     ultrasound examination in connection with LUS procedure increases the number of detected~     liver metastases.~   "
74713|NCT02079376|"~     Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the~     improvement of glycemic control measured by changes in HbA1c.~      Relationship between blood TG level and the GCM efficacy will be evaluated.~   "
74714|NCT02079363|"~     The objectives of this project are to test whether alteration in DNA hypermethylation in~     plasma is:~        -  a diagnostic marker for pancreatic cancer~        -  a prognostic marker for pancreatic cancer~        -  a marker for recurrence of pancreatic cancer~        -  changing during the course of chronic pancreatitis, with the purpose of finding~          patients with high risk of developing pancreatic cancer~   "
74715|NCT02079350|"~     Although the negative impacts of colloid solutions with high molecular weight on renal~     functions, combination of lower molecular weight colloid varieties with crystalloid~     solutions and its use during intraoperative period have been subject to current research.~     Since the first liver transplantation, pre-or post-transplantation renal problems are still~     among the main causes of mortality and morbidity. The aim of the study was to evaluate the~     effects of fluid replacement solutions used intraoperatively on renal functions in elective~     living-donor liver transplantation.This study was approved by the Ethics Committee of~     Hospital and all patients were informed and gave written consent. Participants were patients~     scheduled for elective living-donor liver transplantation. Patients with normal renal~     function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4%~     Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia~     (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR~     formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate~     estimated glomerular filtration rates.~   "
74716|NCT02079337|"~     Use of neuromuscular blockade (NMB) may improve the surgical work space in patients~     scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy,~     myomectomy). Clinical studies investigating this question often use a numerical or verbal~     rating scale for subjective evaluation of the surgical workspace. However, no good~     subjective rating scale have been developed or validated. Neither have possible~     inter-individual differences in use of such subjective scales been described.~      Purpose:~      The aim of this study is to validate different subjective rating scales to determine which~     scale is most useful among surgeons.~   "
74717|NCT02079324|"~     The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after~     intratumoral injection in head and neck cancer patience.~   "
74718|NCT02079311|"~     This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm~     active self-warming blanket differs compared to active warming with forced air warming in~     terms of core body temperature perioperatively.~      A non-inferiority, prospective, open-labelled, randomized, parallel investigation.~      Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air~     warming. All subjects may receive rescue warming if their core temperature falls below~     35.5°C. Rescue warming is optional and defined as the institution's standard of care to~     prevent hypothermia.~      The primary purpose is to investigate if there is a clinically relevant difference in core~     body temperature between the two treatment groups.~      A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each~     treatment group. The number includes a 30% drop-out rate.~   "
74719|NCT02079298|"~     This study will investigate pharmacological interventions between fluconazole and ibuprofen~     when they are given to premature newborn babys. This in order to find out if the drugs are~     influencing each other when they are given at the same time. The study is meant to find out~     if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.~   "
74720|NCT02079285|"~     <Background/aims> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle~     aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been~     demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies~     across EUS programs in Unites States, Europe and other areas of world. The investigators~     have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of~     ROSE, in which the adequacy of specimens will be assessed by a single endosonographer.~      <Methods> All EUS-FNAB procedures will be performed by an experienced endosonographer and~     the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same~     endosonographer. A specimen will be considered adequate if there is an adequate number of~     representative cells from the lesion. Samples considered to be adequate will be then~     interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive~     change, or negative for malignancy. Performance characteristics of EUS-FNAB including~     sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with~     the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up~     of more than 6 months with repeat imagings.~   "
74721|NCT02079272|"~     The purpose of this study is to determine whether a new technique of radiotherapy for breast~     cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first~     two years after treatment. Screening of subclinical cardiac lesions with non-invasive~     cardiac imaging techniques combined with measures of circulating biomarkers of cardiac~     tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity~     at an early stage.~   "
74875|NCT02077270|"~     The main hypothesis is that performance of electroacupuncture before colonoscopy reduces~     pain during the exam.~   "
74722|NCT02079259|"~     The number of patients with acute congestion on chronic heart failure is increasing.~     Ultrafiltration has recently been proposed as an alternative approach for the stabilization~     of volume balance, especially in patients with imminent diuretic resistance.~      There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser~     effects on blood pressure and activation of renin angiotensin system, respectively .~     However, recent studies revealed conflicting results: demonstration the superiority of~     ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as~     well as an excess of adverse events with ultrafiltration.~      Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer~     than aquaphesis with a constant ultrafiltration with comparable effectiveness~   "
74723|NCT02079246|"~     To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive~     therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).~   "
74724|NCT02079233|"~     This is a study to determine the effect of four different dosing regimens of CLP in normal~     healthy volunteers.~   "
74725|NCT02079220|"~     This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety,~     and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line~     treatment of subjects with mCRC.~      Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in~     this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice~     between arm A and arm B will depend on the investigator's preference.~      Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods~        -  Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each~          cycle, repeating every 14 days.~        -  Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every~          14 days.~        -  Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating~          every 14 days.~      Arm B (every 3 week schedule):~      Dosage and dosage regimen for all study periods~        -  Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each~          cycle, repeating every 21 days.~        -  Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every~          21 days.~        -  Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating~          every 21 days.~   "
74726|NCT02079207|"~     This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate~     Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should~     be naïve of Pneumococcal vaccine.~   "
74727|NCT02079194|"~     To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12~     antagonist following 3-month of DAPT in patients undergoing PCI with DES.~   "
74728|NCT02079181|"~     This clinical trial studies the safety and drug distribution of the radioactive drug,~     2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU~     [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in~     patients with advanced cancers. A PET scan is a procedure in which a small amount of~     radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed,~     computerized pictures of areas inside the body where the glucose is taken up. Because cancer~     cells often take up more glucose than normal cells, the pictures can be used to find cancer~     cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find~     out how far the disease has spread.~   "
74729|NCT02079168|"~     To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation~     following elective keloid excision.~   "
74730|NCT02079155|"~     This randomized clinical trial compares a recently developed technique, called robotic~     laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of~     robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in~     treating patients with newly diagnosed, locally confined prostate cancer. Both procedures~     are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate~     though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions~     are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS~     technique, all instruments are inserted through a single incision. R-LESS RP is less~     invasive than RALP and may leave a smaller scar and cause less pain.~   "
74731|NCT02079142|"~     The purpose of this study is to evaluate two training methods of IPT with mental health~     service providers in college counseling centers.~   "
74732|NCT02079129|"~     The study objective is to assess the agreement between cMRI PVL grading (based on~     regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the~     jet arc to the circumference of the annulus).~   "
74733|NCT02079116|"~     This study aims to determine changes in cerebral blood flow of people with obesity after the~     ingestion of fat.~   "
74734|NCT02079103|"~     Background: High intensity training of challenging tasks with many repetitions is a key~     factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation~     systems provide the potential to increase intensity and offer challenging and motivating~     tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered~     studies.~      Methods: In 5 participating rehabilitation centers patients in the subacute phase after~     stroke will be randomized to either a group receiving 4 weeks of VR training in addition to~     conventional arm training or a group receiving dose-matched and therapist attention-matched~     conventional arm-training.~      Hypothesis: VR training is more effective in improving arm motor function than conventional~     arm training in the subacute phase after stroke.~   "
74735|NCT02079090|"~     Sedation and pain medication is required when bone fractures need to be fixed in the~     emergency department (ED). Many drugs have been used safely as single agents or in~     combination for the sedation of children. These drugs include Propofol, Ketamine and~     Fentanyl. However each of these medications has side effects and drawbacks. The combination~     of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of~     Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study~     is to determine which combination works better. The primary outcome of this study is to~     determine which drug combination has a shorter time from onset of sedation to full recovery.~     The investigators hypothesize that Fentofol will have shorter sedation to recovery times.~   "
74736|NCT02079077|"~     In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and~     hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been~     previously associated with natural protection to HIV infection. This phenotype is~     characterized by lower expression of genes involved in cellular activation, lower resting~     levels of inflammatory cytokine production, lower level of systemic activated T cells,~     increased levels of systemic T regulatory, increased production of anti-viral anti-protease~     serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+~     CCR5+ T cells) in the FGT ( female genital tract).~      The objective of this study is to determine if daily oral administration of Acetylsalicylic~     acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative~     women.~   "
74737|NCT02079064|"~     The aim of this prospective randomized study is to evaluate the perioperative effects of~     inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in~     patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM)~     and the traditional laboratory hemostatic markers.~   "
74738|NCT02079051|"~     We are proposing a trial to directly compare a high intensity weight loss protocol to a~     moderate intensity weight loss protocol to determine which leads to greater improvements in~     physical function in severely obese older adults.~   "
74739|NCT02079038|"~     The purpose of this study is to determine safety and effectiveness, as measured by changes~     in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following~     treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with~     lumbar spinal stenosis~   "
74740|NCT02079025|"~     This trial uses a ultra high-resolution ultrasound system and specialized transducer,~     intended for use in prostate imaging. The system's image resolution is significantly better~     than the standard of care, due to its higher frequency. This allows the system to visualize~     suspicious areas and structures, and for greater accuracy for guided biopsy.~      The primary objective of this study is to demonstrate that ultra high-resolution transrectal~     ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound~     (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer~     and with an indication for prostate biopsy.~      The secondary objective of this study is to compare the difference in the rate of detection~     of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator~     training to after investigator training.~      The tertiary objective for the investigation is to compare the combined sensitivity and~     specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs.~     LR-TRUS.~   "
74741|NCT02079012|"~     The purpose of this study is to investigate the short- and long-term effects of a 10-week~     walking program, based on the self-determination theory, in people with mental disorders.~     The investigators expect positive effects on:~        -  Physical fitness~        -  Physical activity~        -  Well-being (less feelings of anxiety, less feelings of depression) The investigators~          also expect underlying psychosocial processes to influence these effects.~   "
74742|NCT02078999|"~     To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons~     and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load,~     procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC),~     American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus~     conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified~     Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period~   "
74743|NCT02078986|"~     The main aim of the study is to determine the effects of Whole-Body Electromyostimulation~     (WB-EMS) on body composition and muscle strength compared with the golden standard High~     Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.~   "
74744|NCT02078973|"~     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and~     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which~     stimulates V1-receptors in the vascular bed and may change both central and brachial~     hemodynamics and plasma concentration of vasoactive hormones.~      The purpose of the study is to measure the effects of tolvaptan on renal handling of water~     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric~     oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).~   "
74745|NCT02078960|"~     To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase~     1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary~     safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP~     or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.~   "
74746|NCT02078947|"~     Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise~     intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also~     termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and~     additionally diastolic function (assessed echocardiographically). The investigators~     hypothesize that exercise training reverses HFpEF and that intensity of exercise training is~     more important than duration.~   "
74747|NCT02078934|"~     Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost~     400,000 ventral hernia repairs annually in the United States. There is an even higher~     incidence of incisional hernia recurrence after prior repair if the patient is obese. Each~     subsequent hernia repair leads to increased morbidity and durability. It is not infrequent~     that many surgeons will advise overweight or obese patients to lose substantial weight prior~     to complex incisional hernia repair.~      However, it is quite difficult for any individual to lose more than 8 pounds a month in a~     safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet~     and exercise alone. Many patients with incisional hernia are physically debilitated that~     they cannot engage in any substantial physical activity to lose weight. Traditional~     laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while~     feasible, is a technically challenging endeavor since prior abdominal surgeries increase the~     amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who~     are not candidates for laparoscopic weight loss surgery because of inability to tolerate~     pneumoperitoneum due to underlying physiologic dysfunction.~      - Novel minimally invasive endoscopic technique may help obese patients with an incisional~     hernia lose weight in a safe and rapid fashion. Early case reports and small case series on~     gastric bypass revision utilizing such endoscopic technique have shown promise in~     efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight~     loss.~      Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a~     primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8~     Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for~     weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System~     (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight~     loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of~     not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric~     greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11~      The intent of this study is not to demonstrate endoscopic suturing to be a primary option~     for weight-loss surgery. Preliminary reports have shown such procedure is technically~     feasible but not durable and the effects of the procedure varied widely among the study~     participants.12 The investigators view this technology as a bridge for morbidly obese~     patients, who will need subsequent surgery for another surgical disease, to improve their~     body habitus and decrease their postoperative morbidity and mortality. The aims of the~     investigators study are:~        -  Feasibility of endoscopic gastric sleeve plication~        -  Define the technical aspects of endoscopic suturing for sleeve plication~        -  Provide long-term follow-up for both weight loss and resolution of their co-morbidities~        -  Time from the endoscopic procedure to their incisional hernia repair~        -  Photographic evidence of the stomach after endoscopic plication during the incisional~          hernia repair~      There are several advantages for the proposed study. First it avoids entering the~     intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the~     need for stapling which may increase the risk of gastric leak from the staple line.13~     Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or~     duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device~     withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices~     will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13,~     14~      The implications of this study can be far-reaching. Once efficacy is demonstrated where~     enough weight loss is achieved that patients can safely and quickly undergo their incisional~     hernia surgery, the investigators can then conduct a retrospective case-control~     cross-matched study to further delineate its true benefit. If there is a true benefit, then~     a randomized control study can be employed in the future.~   "
74748|NCT02078921|"~     Previous studies have shown that interventions which modestly increase blood nitrite_~     improve skeletal muscle function on exercise while sparing oxygen, and have been also shown~     to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the~     diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to~     nitrite, which is then absorbed into the bloodstream. .~      The purpose of this study is to look at the effects of oral inorganic nitrate~     supplementation on clinical markers of heart ischaemia and the frequency of angina.~   "
74749|NCT02078908|"~     The purpose of this study is to investigate the effect of different doses of sodium nitrite~     infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium~     and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central~     blood pressure will be evaluated.~      Hypothesis~      Sodium nitrite infusion~        1. increases urinary sodium excretion and renal filtration rate~        2. lowers blood pressure, central as well as peripheral~        3. affects vasoactive hormones~        4. it is possible to establish a dose that affects the renal function with only minor~          effect on the blood pressure.~   "
74750|NCT02078895|"~     Botulinum toxin type A (Botox A) has shown great success in treating certain urologic~     conditions. A recent study has documented that Botox injected around the ureteral orifice~     (or place where the tube that connects the kidney to the bladder enters the bladder), during~     placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the~     kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced~     by patients. This finding was quite remarkable as stents are commonly used in many Urologic~     conditions, and these stents produce a remarkable degree of patient discomfort. Despite the~     great improvement in pain reduction, the irritative voiding symptoms [frequent need to void,~     urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not~     ameliorated by the Botox injections in the ureteral orifice. However, it has already been~     well documented that in other clinical settings, administrations of Botox into the bladder~     muscle, has been shown to reduce these irritative symptoms.~      The objective of the study is to determine if pain and irritative lower urinary tract~     symptoms related to ureteral stent placement will improve after the injection of Botox~     around the ureteral orifice and in the bladder itself.~   "
74751|NCT02078882|"~     The purpose of this study is to determine if abatacept (Orencia) is effective in patients~     with primary biliary cirrhosis who do not respond adequately to standard treatment with~     ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).~   "
74752|NCT02078869|"~     When patients undergo in vitro fertilization (IVF), they often make more embryos than it is~     safe to transfer back in the womb all at once. These excess embryos are frozen and stored~     for future use. Frozen embryo transfer (FET) is therefore an important option of IVF where~     there are extra embryos. FET should take place under ideal conditions when uterine~     receptivity and uterine endometrial lining thickness are at the appropriate developmental~     stage as the embryo. A common way of preparing the uterus for FET is by using medications~     (Estrogen and Progesterone) that imitate a normal menstrual cycle while monitoring the~     endometrial lining development by transvaginal ultrasound. Progesterone (P4) may be~     administered vaginally or intra-muscularly (IM). The mode of Progesterone administration is~     based upon local conventions, experts' opinion and patients' preferences. All the mentioned~     modalities are common in the daily practice of IVF clinics across the world.~      The current medical literature does not present high quality evidence for the superiority of~     one form of Progesterone administration over the other for FET. The investigators know that~     in fresh embryo transfer cycles where natural follicles continue to function and produce~     Progesterone as corpora lutea, there were no reported differences in pregnancy rates when~     luteal vaginal P4 was compared with IM P4 support, but the investigators do not have the~     same reassurance regarding frozen embryo transfers. The aim of this study is to compare~     vaginal versus IM route of administration of P4 for FET cycle in a well-designed trial.~     Since many outcome variables are possible, the investigators have chosen to concentrate in~     the one that might shed light on a possible biological difference between the two modes of~     Progesterone administration; uterine contractions. Uterine contractions have been previously~     recognized as a possible factor that compromises success rates in patients undergoing IVF~     treatments. Progesterone is considered a uterine relaxant and its levels in the blood versus~     the levels in the uterus differ by its mode of administration: blood levels are higher when~     given IM whereas uterine P4 concentrations are higher when given vaginally. The~     investigators are interested to see whether IM progesterone in frozen embryo transfers~     presents a different uterine contraction pattern than the vaginal administration.~   "
74753|NCT02078856|"~     The purpose of this trial is to determine the efficacy and safety of A3384 administered to~     patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).~   "
74754|NCT02078843|"~     The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher~     diagnostic value in the detection of neuroendocrine tumors than the established imaging~     method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging~     procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the~     investigators will compare the diagnostic performance of both methods.~   "
74755|NCT02078830|"~     The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement~     Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a~     time period of 5 days as a surrogate marker for EVD-associated infections [1, 2], compared~     to a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to~     investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for~     the daily care is as a valuable and effective option to reduce contamination of the EVD~     entry-site and consecutive colonization of the catheter.~   "
74756|NCT02078817|"~     This study will test the use of ketamine for treatment of depression in adolescents that~     have not responded to other treatments. We will also examine neurobiological mechanisms of~     treatment.~   "
74757|NCT02078804|"~     Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000~     new cases each year in Sweden and the disease specific mortality is more than 40%. There~     risk is about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable~     target population for colorectal cancer screening.~      The Swedish ministry of health and social affairs proposed a national study on the~     efficiency of colorectal cancer screening in the Swedish population regarding mortality, but~     also what screening method to be used. Eighteen participating counties of Sweden now fund~     the study to be launched in 2014.~      From the Register of the total population individuals 59-62 years of age will be randomized~     and invited by mail to screening. Twenty- thousand individuals will be invited to primary~     colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10%~     positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second~     round of FIT will be asked for in two years. In total 120 000 randomized individuals will~     not be invited to screening, but followed in the Swedish Cancer register and serve as~     controls. The inclusion period I set to three years (five years with the second round of~     FIT) generating approximately 5 000 colonoscopies yearly the first three years and 1200 year~     four and five at a compliance rate of 50% in the colonoscopy arm and 60% in the FIT arm.~      Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but~     also incidence. Secondary outcomes by others to be studied are in short quality assurance~     variables of colonoscopy, participants and non-participants experiences of the invitation~     and the screening procedure, health economy measures of the CRC-screening study and when~     implemented in clinical care.~   "
74782|NCT02078479|"~     The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary~     motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients~     were divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10~     second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80%~     of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with~     coil elevated and angled away from the head)every day for ten consecutive days (5~     days/week). Patients were evaluated using a verbal descriptor scale (VDS), visual analog~     scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating~     scale for depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15~     days and 1 month after the end of treatment. ic pain.~   "
74758|NCT02078791|"~     The patients who were not pain control, are referred to the Chronic Pain Unit so its~     complexity is greater. Made two different interventions in three groups of people with~     fibromyalgia. In the first group will proceed to infiltrate the painful area with~     medication, in the second GPST (Group Problem Solving Technique) and the third group both~     techniques. GPST will want to identify problems that people associate with fibromyalgia, as~     well as proposed solutions and it they have been carried out successfully or not. Will be~     essential to identifying and solving problems and using techniques to increase~     assertiveness, self-esteem and eliminating negative thoughts. Observing if after performing~     any of these techniques (infiltration, GPST or both) there is a better quality of life,~     reduce thoughts of suicide, pain and improves sleep quality. We also analyzed the~     satisfaction or not with therapies received and perceived usefulness.~   "
74759|NCT02078778|"~     The purpose of this study is to examine the effect on blood pressure of 3 months of~     treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep~     apnea (OSA).~      Hypothesis:~        1. Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure~          more accurately than peripheral 24-h BP monitoring, because the measurement is painless~          and does not interfere with the patient / subject's activities during the daytime or~          nighttime sleep.~        2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.~      3. The renal treatment of salt and water is abnormal in OSA, improved during treatment with~     CPAP.~      4. Quality of life improves during treatment with CPAP~   "
74760|NCT02078765|"~     A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of~     fall in BP during night time) is a strong predictor for the risk of cardiovascular disease~     and mortality in patients with hypertension. Three factors seem to affect the night time BP:~     chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure~     is monitored.~      Hypothesis:~      Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than~     conventional peripheral monitoring.~      In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time~     blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.~      In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in~     hormonal balance.~   "
74761|NCT02078752|"~     To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
74762|NCT02078739|"~     The combined diagnosis of chronic obstructive pulmonary disease (COPD) and heart failure~     (HF) is common but often missed because of similarities in clinical presentation, risk~     factors, and patient characteristics. The concurrent presence of both diseases worsens the~     limitations in exercise capacity and quality of life that patients experience with either~     disease alone. This pilot study will test the feasibility of a yoga program conducted in~     patients' homes using multi-point interactive videoconferencing (Tele- Yoga) for patients~     with combined COPD/HF diagnoses. The investigators hypothesize that patients who receive a~     yoga program at home, compared to an educational control group, will experience fewer~     physical symptoms and better quality of life.~   "
74763|NCT02078726|"~     The investigators believe that glucagon therapy will have a positive impact on key~     parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure~     time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure,~     patient comfort, and patient's willingness to undergo a repeat colonoscopy.~   "
74764|NCT02078713|"~     The investigators have designed a tablet-based decision support tool to help women learn~     more about their birth control options and support them in choosing a method they are happy~     with. The investigators will test whether the decision support tool helps women choose a~     birth control method they can continue using successfully by having some women use the tool~     before their birth control-related visit to a health care provider, and some women not use~     the tool before their visit. The investigators will then follow up with all the women at~     four months and seven months after their visit to see if they are still using the birth~     control method they chose at the visit and how happy they are with the method.~      Hypotheses:~        1. Women who use the contraceptive decision support tool will be more likely to continue~          using their chosen method at 4 and 7 months follow-up, compared to women who receive~          usual care.~        2. The contraceptive decision support tool will increase women's knowledge, choice of, and~          use of highly effective reversible contraception, compared to usual care.~        3. The contraceptive decision support tool will decrease decision conflict, compared to~          usual care.~        4. The contraceptive decision support tool will increase patient satisfaction with the~          clinic visit and with their method, compared to usual care.~        5. Women who use the contraceptive decision support tool will have fewer unintended~          pregnancies during the follow-up period, compared to women who received usual care.~        6. The contraceptive decision support tool will increase shared patient-provider decision~          making in contraceptive counseling visits, compared to usual care.~        7. The contraceptive decision support tool will decrease provider frustration when~          providing contraceptive counseling and increase provider job satisfaction.~        8. Women using the tool will be more likely to report use of any moderately or highly~          effective method of contraception at 4 and 7 months follow-up, compared to women not~          using the tool.~   "
74765|NCT02078700|"~     The objective of this phase 2 study is to evaluate the feasibility of an early palliative~     care intervention for metastatic cancer patients. Feasibility will be assessed in terms of~     percentage of patients that accept the proposal of the early palliative care intervention~     and that effectively start to be followed in the palliative care out-patient clinic. The~     study will be performed in a consecutive series of newly diagnosed patients affected by lung~     cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV),~     stomach (stage IIIb-IV).~   "
74766|NCT02078687|"~     This is a follow-up cohort study of 6 years old children born preterm in Denmark from~     2004-2008, and at four different neonatal units. During hospitalisation they received breast~     milk with fortification. At time of discharge there were made 3 different nutrition groups;~     if possible they were randomised into one of two groups:~        1. Breastfeeding solely~        2. Breastfeeding with fortification~           If breastfeeding was not possible they were put in group 3 and were bottle fed with:~        3. Preterm formula~      This nutrition intervention went on for 4 month. At the age of 6, the children will be~     invited to come for an ambulant control and other examinations regarding growth, allergy and~     metabolic syndrome.~   "
74767|NCT02078674|"~     This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years~     old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by~     prior influenza immunization within the past three months. Subjects 18 to 49 years of age~     will comprise ~67% of subjects in each treatment group, and the balance will comprise~     subjects 50 to 64 years.~      Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0~     and Day 21), in alternate deltoids. For each subject, study follow-up will span~     approximately 385 days total, or approximately 13 months from the first dose.~   "
74768|NCT02078661|"~     To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension~     compared to placebo when administered two times daily for 14 days in subjects diagnosed with~     dry eye syndrome~   "
74770|NCT02078635|"~     Presently in Canada, 29% of deaths are due to cardiovascular disease (CVD), costing $20.9~     billion annually. The investigators have, therefore, brought together an unique network of~     investigators at different stages in their careers with a range of disciplines (nutrition,~     cardiology, diabetes, imaging, physics, clinical trials, statistics, laboratory medicine,~     primary care, genetics, psychology, knowledge translation (KT), and epidemiology) and with~     international recognition , experience and connections, to undertake a multi-centre study~     which will test the ability of the dietary Portfolio PLUS approach over 3 years to reduce~     the progression of plaque build-up in the carotid artery as assessed by Magnetic Resonance~     Imaging (MRI) in individuals with hypercholesterolemia.~      The dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant~     sterol and nuts) which has been proven in many of their studies to be an effective~     cholesterol-lowering diet will be further enhanced by increased levels of monounsaturated~     fats (MUFA) and low glycemic index foods. Will this enhanced dietary strategy (dietary~     Portfolio PLUS ) reduce the progression of carotid atheromatous lesions, LDL-C and blood~     pressure while reducing the number of hyperlipidemic individuals requiring statins?~   "
74771|NCT02078622|"~     Evaluate subjects in an prospective randomized controlled trial in which subjects will be~     administered scientifically validated questionnaires to determine the effect of the~     education and case management by Respiratory Therapists (RTs) on improvements in: health~     outcomes and quality of life as primary endpoints~      Utilize: Chronic Respiratory Disease Questionnaire (CRQ)~      The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency~     room encounters, hospital admissions)~   "
74772|NCT02078609|"~     This study will assess the safety and preliminary efficacy of escalating doses of LGH447 in~     AML and MDS.~   "
74773|NCT02078596|"~     Though the Disruptive Disorders of Childhood and Adolescence are a major source of morbidity~     and fill a large proportion of special education slots, specific pharmacologic treatment is~     available only for those children with Attention Deficit/Hyperactivity Disorder. Other~     disruptive children are usually said to have Oppositional Defiant or Conduct Disorder.~     These diagnoses are useful descriptively but they do not have specific treatment~     implications In the course of treating adolescents with explosive tempers and severe mood~     swings with Depakote (divalproex sodium), the investigators learned that younger children~     manifest symptoms that seemed identical to those constituting the adolescent disorder. They~     were in special education programs and not responding to psychostimulants.~      The investigators systematically collected data on these children using the same screening~     criteria as in our studies of adolescents. Since Depakote has been used to treat seizures in~     children for more than twenty years, a great deal was known about its safety profile in the~     pediatric population. The investigators treated 7 children, age 7-12, whose recurrent temper~     outbursts and chronic mood lability did not respond to individual/family therapy. After~     parents signed informed consent and children gave assent, these subjects would receive open~     label Depakote in doses sufficient to reach a blood level between 50-100 micrograms/ml for~     six weeks. The family received supportive therapy.~   "
74774|NCT02078583|"~     Benzodiazepines is a commonly uesd sedative medication,there are many reports that~     Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines~     requirements .The purpose of this study is to determine whether analgesia based sedation~     protocol reduces the incident of delirium.~   "
74775|NCT02078570|"~     The major purpose of this study is to evaluate a laboratory developed test that measures~     multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood~     samples. The biomarker and antibody results along with your personal medical profile will be~     evaluated to determine your risk for the presence of a malignancy in the breast as compared~     to your breast evaluation assessment conducted by your physician.~   "
74776|NCT02078557|"~     This study will assess multiple doses of MK-8892 administered to participants with pulmonary~     hypertension out of proportion (PHOOP) and heart failure with reduced left ventricular~     ejection fraction (rEF). It is hypothesized that generally safe and well tolerated multiple~     doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular~     resistance (PVR) greater than 12%.~   "
74777|NCT02078544|"~     The purpose of the study is to identify biomarkers and potentially actionable mutations/~     activated molecular pathways and evaluate the impact of molecular profiling information on~     patients with gynaecological cancer.~      The hypothesis of the study are:~        -  Analysis of gynaecological tumour samples will allow us to identify novel and/or~          actionable molecular changes that may drive therapeutic strategies for the management~          of these cancers.~        -  Molecular profiling will improve the outcome of novel targeted-agent treatment in~          clinical trials~        -  Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will~          provide new insights into mechanisms underlying drug resistance and metastasis in~          gynaecological cancers.~   "
74778|NCT02078531|"~     The purpose of the study is to examine cognitive and brain function in stage I-III breast~     cancer patients who have undergone adjuvant systemic therapy (chemotherapy or chemotherapy~     plus anti-hormonal therapy) in comparison to a group of healthy controls.~      Our hypothesis is that systemic adjuvant therapy in the form of chemotherapy or chemotherapy~     and anti-hormonal therapy given to primary breast cancer patients can cause cognitive~     impairment. We hypothesize that the use of simultaneous PET/MRI will allow us to determine~     key regions in the brain that show metabolic, structural, and functional deficits in a~     semi-quantitative manner and reveal subtle changes that are often missed during~     neuropsychological tests due to the low sensitivity of neuropsychological batteries.~   "
74779|NCT02078518|"~     The purpose of this study is to gives understanding to level of physical activity,~     occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local~     setting. As multiple myeloma survival improves, it is vital to focus on interventions that~     will help to maximize QOL. A positive correlation may suggest that exercise is such an~     intervention.~      The hypothesis are multiple myeloma survivors are performing low levels of physical~     activity. Higher levels of physical activity will be associated with higher levels of QOL~     and lower fatigue levels.~   "
75235|NCT02072577|"~     Supervise dental conditions and teach the procedure of oral hygiene are the responsibility~     of the nurse. Patients on chemotherapy have risk for oral and systemic changes factors. The~     investigators will evaluate the cognitive and procedural knowledge about oral hygiene and~     the relevance of the learning experience importance.~   "
74784|NCT02078453|"~     Radiographs have been used to aid dentists in detecting the presence of cavities in the~     deciduous teeth of children. This procedure is globally recommended because the conventional~     clinical examination usually overlooks some cavities. However, the real benefit of~     performing dental radiographs for this purpose is still unclear. Besides the hazards of~     ionizing radiation, the radiographs could provoke overtreatment of the children; hence,~     dentists would tend to restore more teeth than would be really necessary. Nowadays, it is~     preferable to overlook some cavities than treat the teeth unnecessarily. Therefore, the~     investigators aimed to perform this study to compare two different strategies for detecting~     cavities in deciduous teeth of children: one based on clinical examination performed alone~     and other using radiographs adjunct to the clinical examination. To compare these~     strategies, the investigators will consider outcomes related to children's health and~     welfare.~   "
74785|NCT02078440|"~     The objective of this study is to evaluate the relative bioavailability, and the rate and~     extent of absorption of bromocriptine in male and female children and adolescent Type 2~     Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions.~      It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes~     children aged 10- to less than 18 years differs appreciably from that in healthy adults.~     Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children~     have demonstrated little difference in clearance among children over 10 years of age~     compared to adults (Blanco et al, 2000). However, differences in blood volumes or other~     factors may impart differences that could affect the pharmacokinetic properties of~     bromocriptine-QR. Therefore, this study will assess the pharmacokinetics in children aged~     10-to less than 18 years who have type 2 diabetes. After describing the profile of~     bromocriptine-quick release in this patient population, a follow on study will be conducted~     to evaluate its safety and efficacy in treating children and adolescents who have type 2~     diabetes.~      The pharmacokinetic profile of bromocriptine will be determined following the administration~     of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study~     will be a single period, bioavailability study in 30 patients. The study duration will be 3~     days.~   "
74786|NCT02078427|"~     The purpose of the study is to document the natural history of hemophilia. A disease and~     long-term outcomes in terms of effectiveness, safety and quality of life (QoL) in~     participants receiving ADVATE in routine clinical practice. Participants may use any~     treatment regimen, including on-demand and prophylaxis using standardized regimens or~     individual pharmacokinetic (PK)-guided dosing regimens, or immune tolerance induction (ITI)~     therapy, as determined by the treating physician.~   "
74787|NCT02078414|"~     Women using an emergency contraceptive method must use back up protection for 1-2 weeks~     depending on method. The Copper-IUD is the most effective emergency contraceptive method.~     The investigators wish to explore if women choosing the Cooper IUD have a higher frequency~     of use of an effective contraceptive method 3 months and 6 months after the use of an~     emergency contraceptive method than women who choose to use the emergency contraceptive pill~     EllaOne (ulipristal acetate).~   "
74788|NCT02078401|"~     The goal of this project is to get more insight into the (neuro)ophthalmological~     characteristics of children with neurofibromatosis type 1. This way investigators would like~     to update the current guidelines for follow up and treatment of optic pathway gliomas.~     Clinical findings will be compared with the results of Optical coherence tomography (OCT)~     and MRI (magnetic resonance imaging).~   "
74789|NCT02078388|"~     The purpose of this study is to identify the genetic variants that are associated with~     higher risk of doxorubicin-induced cardiotoxicity can contribute towards developing a~     predictive algorithm comprising both clinical and genetic factors to select patients who~     should avoid treatment with anthracyclines.~      Hypothesis of this study is certain functional variants in genes that encode for~     metabolizing enzymes and/or targets in the doxorubicin pharmacology pathway may increase the~     risk of doxorubicin-induced cardiomyopathy~   "
74790|NCT02078375|"~     This study will evaluate if the combination of resistance exercise and protein~     supplementation will increase muscle strength and muscle mass among older individuals with~     rheumatoid arthritis (RA).~   "
74791|NCT02078362|"~     Peripheral blood will be taken from the enrolled patients at National University Hospital~     and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new~     medicine candidates.~   "
74792|NCT02078349|"~     This is an open-label, dose-escalation (Phase 1a) and expansion (Phase 1b) study to evaluate~     the safety and tolerability of KPT-330 and determine the recommended phase 2 dose (RP2D) in~     patients with solid tumor malignancies. The study drug KPT-330 or Selinexor works by~     blocking high levels of exporter proteins in cancer cells so that the tumor suppressor~     proteins (TSP, proteins that help to protect cells from becoming cancerous) and growth~     regulatory proteins (GRP, proteins that help control the growth of cells) will remain in the~     nucleus in its activated form. The idea for using this drug is that the blockage of this~     export of proteins from the nucleus should result in stopping the growth of tumor cells.~     Based on its mechanism of action, KPT-330 is a new class of drug called Selective Inhibitor~     of Nuclear Export (SINE).~      The purposes of this research study are to find out more information about the drug such as:~     the highest dose of KPT-330 that can be given safely, the side effects it may cause, to~     examine how the body affects the study drug concentrations in the blood (called~     pharmacokinetics or PK), to examine the effects of this study drug on the body (called~     pharmacodynamics or PD) and to gain some information on its usefulness in treating cancer.~      Benefits of the study include the chance of disease control for patients with treatment~     refractory cancer for which no other standard treatments are available. Common side effects~     (35-73%) in humans have mostly been mild and reversible. These include nausea, loss of~     appetite, fatigue, vomiting and weight loss.~   "
74793|NCT02078336|"~     The study aims to compare procedural sedation protocols, specifically applied for the~     delivery of regular dental care in persons with a mental disability.~      The primary objectives are:~        -  To assess the level of cooperation during regular dental care using different~          procedural sedation protocols~        -  To assess patient safety during regular dental care using different sedation protocols~        -  To assess patient comfort and possible side-effects after regular dental care using~          different sedation protocols~   "
87749|NCT01908777|"~     The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in~     patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous~     transplantation.~   "
74794|NCT02078323|"~     The purpose of this study is to understand how a drug called Linaclotide improves bowel~     function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation~     (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and~     pelvic-floor region.~      Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is~     approved by the FDA for the treatment of this condition. However, how exactly this drug~     works to relieve abdominal pain and discomfort in humans is not clearly known. Studies in~     animal models suggest that patients with IBS-C have hypersensitivity in the gut.~      Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both~     from the brain and central nervous system region towards the pelvic-floor (anorectal axis)~     and the reverse direction. The investigators hypothesize that treatment with Linaclotide may~     improve/normalize these signals and thereby improve bowel symptoms.~      Investigators will test this theory using a new, noninvasive (and established) method of~     studying this communication pathway between the brain and gut.~   "
74795|NCT02078310|"~     A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation~     Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric~     Volunteers and in Geriatric Patients with Dementia~   "
74796|NCT02078297|"~     The goal of this project is to study some mechanisms involved in the dysregulation of the~     immune system observed in the skin of subjects with psoriasis. This will be done by~     analyzing specific immune cells as well as gene and protein expression in small skin samples~     (biopsies) from patients with psoriasis. These results will be compared to the skin of~     healthy subjects without psoriasis.~   "
74797|NCT02078284|"~     This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide~     (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO)~     Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the~     past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related~     parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.~   "
74798|NCT02078271|"~     WHO has urged all developing countries to develop programmes to improve~     complementary-feeding (CF) practices because of their importance for optimal growth,~     development and health of infants and young children While supplementation programmes and/or~     highly-fortified super-foods have limited success in improving CF-practices in~     disadvantaged environments, population-specific food-based dietary guidelines (FBDG), based~     on locally-available foods and requires minimal changes to local food pattern, will enhance~     the chances of programme success.~      Our previous study was able to identify the need for, potential and finally develop FBDG for~     CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP~     approach). This research is therefore being made to support the next phase of the study i.e.~     to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in <24mo~     children (window of opportunity). As growth and development is inter-related, home-based~     stimulation will be included in this trial to see the effect on child development. While~     studies have shown that stimulation at early age benefits children through their late~     adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect~     on growth and development of community trial using food-based dietary guideline and~     stimulation. It is expected that findings from this study will provide scientific evidence~     as the basis for program formulation.~   "
74799|NCT02078258|"~     In this study, we test whether a two-week 8-session attention bias modification (ABM)~     training could reduce depressive symptoms relative to placebo controls in adolescents with~     major depressive disorder at posttraining and follow-ups.~   "
74800|NCT02078245|"~     Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a~     positive impact in survival for patients with an increased genetic risk to develop pancreas~     cancer.~      In this study, following the indication of the swedish guidelines, consecutive patients with~     a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance~     Imaging (MRI) based. The results of this study were analyzed looking in the patients files~     collected during the screening period.~   "
74801|NCT02078232|"~     The purpose of this study is to compare the diagnostic gain between 22G standard needle vs~     19G Flex needles transduodenal punctures of masses of the pancreatic head.~   "
74802|NCT02078219|"~     This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients~     with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg~     once daily, respectively will result in greater reduction of sUA compared to placebo.~   "
74803|NCT02078206|"~     The purpose of this project is to assess the efficacy of an early neurocognitive~     intervention for ICU patients, in terms of psychopathological, neuropsychological and~     functional improvement. The treatment is supported in an interactive advanced computing~     platform that includes the continuous biomedical registration of the patients and a virtual~     reality software specifically designed for critical patients.~      The investigators expect an improvement in neuropsychological, psychopathological and~     functional status at hospital discharge and 3 months follow-up in those patients that have~     received the early neurocognitive intervention comparing with patients treated as usual.~     Furthermore the investigators expect a decrease of episodes and/or duration of delirium in~     ICU patients.~   "
74804|NCT02078193|"~     The primary objective of this study is to demonstrate that administration of belatacept in~     maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA~     Antibody (DSA).~   "
74815|NCT02078050|"~     Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and~     volitional measures of inspiratory muscles strength include the nasal pressure with an~     occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately,~     volitional maneuvers depend of patient effort. The aim of this research is to validate a~     non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular~     diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic~     nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3~     inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).~   "
74816|NCT02078037|"~     Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either~     the experimental group which will keep them at a normal body temperature or the standard of~     care group. The investigators propose to test the hypothesis that prophylactic forced~     normothermia in patients with ICH leads to less systemic inflammation and decreased~     perihematomal edema.~   "
74805|NCT02078180|"~     The objectives of this project are to determine if the bioavailability and release pattern~     of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the~     saturation of intestinal enzymes with different dose strengths within one product line.~     Findings from this project will help the FDA Center for Drug Evaluation and Research's~     (CDER) Office of Generic Drugs improve policy development and review practice in the future~     for similar products, e.g. extended release oral drug products being metabolized in the gut~     wall and having multiple strengths.~      Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy~     individuals when they ingest different strengths of bupropion (75-300 mg) with variable~     release profiles (IR vs XL vs SR) in GI tract.~      Working hypothesis: Variation in release rate and mechanism of bupropion formulations in~     gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract,~     which will generate different concentration of bupropion and its metabolites in plasma.~      Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation,~     and pharmacokinetics of bupropion~      Working hypothesis: The gain of function of CYP2B6 variants (allele *4 and *22) in patients~     will increase the metabolism of bupropion in the GI tract and liver, reduce both local~     concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when~     bupropion is released earlier in GI tract~   "
74806|NCT02078167|"~     Background: Statins are at the forefront of strategies to manage hypercholesterolemia.~     However, 10-15% of patients result to be intolerant to any statins, even at low daily doses~     and almost one- third of statin users discontinue therapy within one year. Some~     nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their~     efficacy and tolerability. In this study we investigated the effects of a nutraceutical~     combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg~     monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).~      Methods: In this single centre, randomized, double-blind, placebo-controlled study 60~     consecutive outpatients (age range: 18-60 years), with newly diagnosed primary~     hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable~     hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once~     a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability~     of the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of~     treatment.~   "
74807|NCT02078154|"~     Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest®~     D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein~     Thrombosis (DVT) Data from this study may be used in conjunction with data from the~     prospective study entitled STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism~     (VTE), NCT01221805, the DiET study,~   "
74808|NCT02078141|"~     18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a~     promising tool for identification of myocardial inflammation in patients with dilated~     cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the~     fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the~     frequency and describe the different binding profiles in comparison with MRI data.~      Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.~      All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A~     high fat and low carbohydrate diet and an heparin injection will be prescribed to patients~     before this FDG PET.~      Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be~     completed by a 12 months evaluation.~   "
74809|NCT02078128|"~     The purpose of this study is to determine the effect of β-glucans on wound healing.~   "
74810|NCT02078115|"~     The purpose of this study is to find the change of blood pressure (BP) control pattern (true~     controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper,~     reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3~     years. And Other objective is the relationship between the BP control pattern and the target~     organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and~     so on. In addition, we will find clinical factors related to the BP control pattern.~   "
74811|NCT02078102|"~     The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral~     meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing~     autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's~     lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support.~     Clinical data regarding the cellular composition and function of the graft mobilized by this~     combination will be obtained.~   "
74812|NCT02078089|"~     This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with~     morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the~     safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary~     endpoints are improving pain control, reduce morphine use and improve the quality of life.~   "
74813|NCT02078076|"~     Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis~     detection and quantification (and of function assessment) during MRI without breath-holds in~     a population of adults and children with Duchenne myopathy.~   "
74814|NCT02078063|"~     Use of long acting reversible contraception (LARC) such as implants or intrauterine~     contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of~     being independent of user error and are considered to be underused, especially among young~     individuals where oral methods have high rates of user failure. IUC is often underused in~     young or nulliparous women due to fear of pain at insertion.~      10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the~     uterine cavity through a hydrosonography catheter before the tenaculum has been applied but~     prior to sounding and to insertion of the IUC.~      The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a~     hydrosonography catheter prior to any instrument placement will provide more effective pain~     relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).~      Primary objective: To evaluate the difference in pain score at the time of the insertion of~     the IUC between treatment and control group.~      Secondary objectives: To evaluate acceptability of the procedure.~   "
75236|NCT02072564|"~     The purpose of this study is study the possible relationship between various lifestyle~     habits of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee,~     etc..) and live birth rate after in vitro fertilization-intracytoplasmatic injection~     (IVF-ICSI).~   "
74818|NCT02078011|"~     The purpose of this study is to test an investigational device called the Echopulse for~     treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast~     tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in~     groups, or as a complex of lumps together. Sometimes women feel these in the breast when~     doing regular self breast exams, or they may be found during a routine mammogram. Some are~     small (less than an inch in size), and others are quite large (the size of a lemon or~     larger).~      This is a study about the Echopulse device, a computer driven system which uses ultrasound~     to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in~     the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which~     causes the cells to die and allows the possibility to treat the fibroadenoma without the~     need for surgery.~   "
74819|NCT02077998|"~     This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and~     blood and the side effects and how well oxaliplatin works in treating patients with~     metastatic breast cancer. DNA analysis of tumor tissue and blood samples from patients~     receiving carbon C 14 oxaliplatin may help doctors predict how well patients will respond to~     treatment with oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing.~   "
74820|NCT02077985|"~     The goal of this project is to collect information that will support a later clinical trial~     on the effectiveness of a specially adapted dental environment for children who have~     difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the~     sensory environment in the dental office by modifying the sounds, sights, smells and tactile~     experiences will result in decreased anxiety, increased cooperation, and fewer behavior~     problems for children with Autism Spectrum Disorders, and to a lesser extent for typically~     developing children especially those who have dental anxieties. This has the potential~     contribute to increased child comfort as well as safer, more efficient, and less costly~     treatment for a large population, as potentially more than one-fourth of all children may~     benefit from a sensory adapted dental environment.~   "
74821|NCT02077972|"~     Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing~     public health problem in the United States following the overseas wars of the last decade.~     Rates of PTSD have skyrocketed in the military and among veterans, leading to increased~     rates of suicide, impairment on the job and off, and behavioral changes that negatively~     affect not just the veteran, but also his or her family. Although effective medication and~     psychotherapy treatments exist for combat-related PTSD, many individuals suffering with PTSD~     do not adequately respond to currently available treatment options, highlighting the need to~     develop and test new interventions for the disorder. To address this pressing clinical~     issue, the investigators will conduct a pilot study to determine if Whole Body Hyperthermia~     (WBH) reduces symptoms in adults suffering from combat-related PTSD. The investigators plan~     to recruit a sample of 10 medically healthy individuals with combat-related PTSD who will~     receive a single session of WBH to determine if this single session improves PTSD symptoms~     and, if so, whether this improvement will last at least 2 weeks. To do this, the study will~     include basic clinical and psychiatric assessments immediately before and one and four weeks~     after WBH. Because sleep is so often impaired in PTSD, the investigators will measure~     at-home sleep patterns for a week prior to and a week following the WBH session using sleep~     diaries and a wristwatch actigraphy device. Given scientific evidence from our research~     group that WBH may improve depression, the investigators anticipate that it may also be of~     benefit or adults suffering from combat-related PTSD.~   "
74822|NCT02077959|"~     This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab~     and to see how well they work in treating patients with multiple myeloma that has come back~     (relapsed) or has not responded to treatment (refractory). Biological therapies, such as~     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from~     growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the~     ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better~     in treating relapsed or refractory multiple myeloma.~   "
74823|NCT02077946|"~     This trial is conducted in Europe. The aim of this study is to investigate a retrospective~     database assessment of clinical effectiveness in type 2 diabetes patients treated with~     liraglutide from primary care centers in Sweden.~   "
74824|NCT02077933|"~     Dose escalation part: to determine the highest dose of alpelisib administered on a daily~     basis when given in combination with daily everolimus or in combination with daily~     everolimus and exemestane.~      Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or~     alpelisib, everolimus and exemestane combinations.~   "
74825|NCT02077920|"~     Ventilator-associated pneumonia (VAP) is common in patients receiving mechanical~     ventilation, and is associated with longer hospital stay, increased treatment costs, and~     higher rates of morbidity and mortality . VAP is reported to occur in 8%-67% of mechanically~     ventilated patients (20%-28% in most reports) and has a mortality rate of 24%-50%, which is~     2-3 times the mortality rate of mechanically ventilated patients without VAP. In patients~     infected by multi-resistant bacteria, the mortality rate may be as high as 76%. The~     diagnosis, treatment, and prevention of VAP are therefore important. Strategies for~     preventing VAP are crucial for reducing medical costs and increasing survival rates in~     critically ill patients. These strategies mainly involve a semi-reclining position with the~     head of the bed raised to at least 30°-45°, oral care, suctioning of subglottic secretions,~     selective decontamination of the digestive tract, proper hand washing, avoidance or~     reduction of proton pump inhibitors, avoidance of excessive sedation, and control of plasma~     glucose levels.~      At our center, VAP is mainly caused by bacterial colonization of the upper respiratory tract~     via aspiration. This study will compare four interventions including oropharyngeal~     decontamination and subglottic suctioning by bronchoscopy, with the aim of developing a~     prevention strategy to minimize the development of VAP during mechanical ventilation.~   "
74929|NCT02076568|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and partnership. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome~     variables are: diabetes-related distress, health-related quality of life, depressive~     symptoms, self-care behavior, and glycemic control.~   "
74826|NCT02077907|"~     The objective of this study is to test and compare the effectiveness and cost-effectiveness~     of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal~     programmatic settings in Sierra Leone. Study participants will receive one of four test~     foods varying in energy and nutrient density as well as amounts provided.~        1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)~        2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g~          sugar, per day~        3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day~        4. Plumpy'Sup - 500 kcal/d, 92 g/d~      This will be a prospective, randomised, controlled effectiveness trial.~      Aims~        1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of~          moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.~        2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered~          from MAM, relative to comparison group, SC+) of implementing the feeding program using~          each commodity, taking into consideration costs of procurement/production and~          distribution~        3. (Process) To evaluate the determinants of effectiveness including: consumption~          adherence, preparation compliance, targeting/sharing of supplement, food components and~          preparation, adverse effects of foods, water contamination, hygiene and health~          behaviors, SES, food security, perceived barriers~      Outcomes~        1. Recovery from MAM~             1. Percent of children recovered from MAM (defined as achieving mid-upper arm~               circumference (MUAC) ≥ 12.5 cm by 12 weeks once)~             2. Percent default/non-response: children who do not recover after 12 weeks~             3. Percent relapse: children who become MAM again within 6 months of recovery~        2. Mean number of weeks to recovery~      Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or~     Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.~      Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup~     will have different recovery outcomes to those children fed Super Cereal Plus.~   "
74827|NCT02077894|"~     Objective: The objective of this study is to identify genetic causes of inherited eye~     conditions through whole exome or whole genome sequencing. This includes identifying~     mutations in known genes or novel genes for recognized conditions, as well as identifying~     mutations in novel genes for previously uncharacterized genetic conditions involving the~     eye.~      Study Population: We plan to recruit 310 participants, to include both probands with an eye~     condition under study and unaffected family members. Ideally unaffected family members will~     be parents of a proband.~      Design: Participants will be recruited through other pre-existing NIH protocols, such as the~     NEI Evaluation and Treatment protocol (08-EI-0169), the NEI Screening protocol (08-EI-0102),~     and the Genetics of Uveal Coloboma protocol (13-EI-0049). Self-referred patients or patients~     referred by an outside clinician will be screened for eligibility under a pre-existing NIH~     protocol. Phenotyped patients eligible for participation and their unaffected family members~     will undergo genetic counseling and will provide a blood sample for exome or genome~     sequencing. Biological relationships will be confirmed prior to exome or genome sequencing.~     Sequence data will be analyzed for primary variants associated with the proband s eye~     condition and incidental findings, as recommended by the American College of Medical~     Genetics guidelines. All sequence variants deemed clinically relevant will be validated in a~     CLIA-certified laboratory and the results will be returned to the participant in-person.~      Outcome Measures: This is an etiologic study that will generate molecular information about~     previously-recognized conditions for which participants did not have a molecular diagnosis,~     as well as molecular information for previously uncharacterized conditions involving the~     eye.~   "
74828|NCT02077881|"~     This phase I/II trial is designed to efficiently identify the regimen limiting toxicity~     (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent~     indoximod when administered in combination with standard of care chemotherapy gemcitabine~     plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects~     will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in~     doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.~   "
74829|NCT02077868|"~     The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a~     maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal~     cancer.~   "
74830|NCT02077855|"~     This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is~     important, because it obviates the need for investigations to archive adequate treatment as~     well as to prevent unnecessary immobilization. The value of sonographic diagnosis of~     toddler's fracture has been demonstrated. The aim of the present study is to investigate the~     reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.~   "
74831|NCT02077842|"~     The purpose of this study is to determine whether prophylactic nasal continuous positive~     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative~     pulmonary function following elective bowel surgery. The investigators hypothesize that one~     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)~     when compared to the standard treatment of low flow oxygen applied by face mask.~   "
74832|NCT02077829|"~     The purpose of this study is to examine the barriers and facilitators of implementing~     Illness Management and Recovery (IMR) in Norwegian mental health services.~   "
74833|NCT02077816|"~     This is a pilot study which aims to show the temperatures measured on body surface with an~     infrared thermometer on inpatients who need a central venous catheter (CVC) for medical~     care. Because the local temperature could be altered, at least during local infectious~     processes, seems to be reasonable to think that this approach could be helpful to its early~     diagnosis.~   "
74834|NCT02077803|"~     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in~     blood among the formulations) of the fixed dose combination (two components combined in one~     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000~     mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR~     tablet (4 x 500 mg) in healthy fed participants.~   "
74835|NCT02077790|"~     This study is to support the substantial equivalence of the SS-1000 to the predicate device~     Pentacam.~      Primary Objective -The primary objective of the trial is to evaluate the precision of the~     SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including~     Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.~      Secondary Objectives~        -  To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in~          measuring the anterior segment parameters in an eye~        -  To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in~          measuring the anterior segment parameters in an eye~        -  To investigate the agreement between SS-1000 and Pentacam in measuring the anterior~          segment parameters in an eye~      Study design~      -The trial design is a prospective precision trial with the following factors: The trial~     will be conducted at one investigational site. The site will have three SS-1000 devices and~     three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly~     assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are~     confounded with instrument effect. All participants will have one visit and undergo the same~     set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).~   "
74838|NCT02077751|"~     Objective: To gather safety and efficacy BioRBC data from adult subjects who previously~     developed transient BioRBC antibody responses by redosing them and observing for adverse~     clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC~     kinetic study results differ from the previous study.~      Hypothesis: BioRBC survival studies performed in adult subjects who previously developed a~     transient BioRBC antibody response will: 1) be associated with no adverse clinical or~     laboratory events; 2) experience a second transient, BioRBC antibody response; and 3)~     display a pattern of RBC survival that is identical to their prior dosing with BioRBCs at~     the same dose.~   "
74839|NCT02077738|"~     The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation~     (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to~     test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater~     improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success~     rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with~     intra-tracheal intubation.~   "
74840|NCT02077725|"~     Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a~     patient-centered medical home~      Objectives:~      The primary objective of this project will be to track the types of interventions made in an~     interdisciplinary polypharmacy clinic to improve medication regimens and medication burden.~     Polypharmacy has been well documented in the literature as a risk for medication errors,~     adverse drug events, and morbidity. Team visits, including complete medication reviews, by~     pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3~     patient-centered medical home (PCMH) at an academic medical center, can improve medication~     regimens. Secondary objectives include (1) measuring each patient's quality of life at~     baseline and one month post-intervention and (2) tracking the cost of medication additions~     and discontinuations.~      Methods:~      Patients taking ten or more chronic medications will be identified for referral to the~     polypharmacy clinic from a report generated from the electronic medical record. The~     polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from~     an attending physician who specializes in geriatrics. Drug-related problems identified~     during the visit will be resolved and categorized based upon indication, efficacy, cost,~     safety, and compliance. The numbers and types of interventions made, both during the primary~     visit and anticipated in the future, will be tracked. The 12-item short form (SF-12) survey~     will also be administered at baseline and one month post intervention. The increase or~     decrease in cost for medications added and removed during these visits will be captured~     using the average wholesale prices.~      Preliminary Results Using descriptive statistics, the types of drug-related problems~     identified and interventions made will be reported. Changes in quality of life and monthly~     medication costs will also be described.~   "
74841|NCT02077712|"~     2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children~     for ophthalmic examinations than the sedative effect of 1ug/kg.~   "
74842|NCT02077699|"~     The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus~     casei DG in the reduction of the painful symptoms in patients affected by irritable bowel~     syndrome. After that, the secondary object is to evaluate if the reduction of painful~     symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.~   "
74843|NCT02077686|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and travel. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and travel. Secondary outcome variables~     are: diabetes-related distress, health-related quality of life, depressive symptoms,~     self-care behavior, and glycemic control.~   "
74844|NCT02077673|"~     Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a~     massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with~     upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology,~     Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted~     laparoscopy, is in the progress of being implemented in this field as they are hypothesized~     to be more beneficial for the patients, and in some aspects better than conventional~     laparoscopic surgery.~      The operative procedure is often complicated by low blood pressure (systolic blood pressure~     less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably~     accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity.~     Hypotension may be due to several factors, among them are epidural analgesia, mesentery~     traction reflex, and inflammatory and vasoactive hormones.~      Aim of the project~      The aim of the project is, through a series of sub-projects, to validate or invalidate the~     relationship between changes in the microcirculatory blood flow in the stomach and the~     systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the~     microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In~     addition, the aim is to assess the hypothesis that the mesenteric traction reflex and~     changes in the PGI2 levels may influence systemic hemodynamic changes, and that robotic~     assisted MIT will attenuate the mesenteric traction reflex and changes in PGI2 compared to~     open surgery.~   "
74845|NCT02077660|"~     The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks)~     green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and~     antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric,~     inflammation and metabolic parameters in a healthy aging men and women.~   "
74846|NCT02077647|"~     The primary objective of this registry is to assess the functional outcome measured with the~     Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial~     unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The~     aim of the Focused Registry is to complete the data collection and enable a sound analysis~     for the Tomofix Small size study.~   "
74847|NCT02077634|"~     This is an exploratory Phase 2 multicenter, randomized, open-label study with a~     randomization allocation ratio of 1:1 [abiraterone acetate + prednisone + LHRH-therapy (Arm~     A) versus abiraterone acetate + prednisone (Arm B)]. For both groups patients will receive a~     dose of 1000 mg abiraterone acetate and 10mg prednisone daily (QD). Study drug will be~     administered as 4 x 250-mg abiraterone acetate tablets and prednisone will be administered~     as 5 mg orally twice a day (BID). Patients randomized to the LHRH-therapy group will receive~     the same LHRH-therapy they received prior to entering the trial. 70 medically castrated male~     patients with metastatic CRPC who have shown tumor progression and are non- or~     mildly-symptomatic will be enrolled from approximately 12 German study sites.~   "
74848|NCT02077621|"~     PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer~     patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue~     relief in patients undergoing palliative abdominal surgery for cancer. The secondary~     endpoints, including the length of hospital stay, postoperative complications, HRQL,~     inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital~     stay, weight loss and body composition, will be evaluated among these patients.~   "
74850|NCT02077595|"~     Recently, non-invasive brain stimulation has become a powerful tool in both basic research~     and clinical application. Among several non-invasive brain stimulation techniques,~     transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS)~     have received the most attention. About DC stimulation, the change of polarity could~     modulate the spontaneous neuronal activity and make effect on decision making, language,~     memory, sensory perception, and pain. In spite of that the concept of transcranial~     alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC,~     and researches have revealed that AC might potentially have the effect on the cortical~     excitability. However, there are still many areas about AC stimulation which remain unknown,~     such as mechanism, application, and potential influence on cortical excitability.~   "
74851|NCT02077582|"~     The objective of this trial is to visualize blood brain barrier function and metabolic~     changes in the first days after ischemic stroke with new investigational MRI sequences.~   "
74852|NCT02077569|"~     To compare the effect of four and a half days treatment of a range of doses of AZD5363 on~     selected markers of the AKT pathway and anti-proliferation compared with placebo in~     oestrogen receptor positive breast cancers.~      To assess the tolerability of four and a half days treatment of AZD5363.~   "
74853|NCT02077556|"~     The purpose of this study is to understand the effects of everolimus on tacrolimus~     pharmacokinetics (pk) in patients receiving de novo kidney transplants.~   "
74854|NCT02077543|"~     The purpose of the study is to determine the innocuity and operability of the innovative~     tumor molecular and cellular print ProTool.~   "
74855|NCT02077530|"~     Patients with metabolic syndrome living in Seoul area are included in this prospective~     registry for more than 10 years. All enrolled patients undergo thorough medical history~     survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse~     wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass~     evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6,~     TNF-alpha, VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat~     the test and survey every year in Korea University Hospital.~   "
74856|NCT02077517|"~     The purpose of this study is to compare postoperative complications between hand sewn and~     stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid~     obesity.~   "
74857|NCT02077504|"~     The purpose of this study is to determine the correlation between functional MEG analysis of~     the tumor and its periphery and the tumor stage and treatment response.~   "
74858|NCT02077491|"~     The purpose of this study is to determine the effect of a high-protein diet during~     hospitalization in combination with resistance training and a daily protein and energy~     supplement three months after discharge on the muscle mass, muscle strength, functional~     ability and weight in acutely ill old medical patients.~   "
74859|NCT02077478|"~     test the following differences between Schinder's Target Controlled Infusion (TCI ) model~     and manually controlled infusion (MCI) :~        -  remifentanil and propofol total dose given~        -  incidence of awareness or inadequate anesthesia~        -  number of rescue dose given~   "
74860|NCT02077465|"~     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple~     infusions of GS-5745 in participants with chronic obstructive pulmonary disease (COPD) as~     assessed by adverse events (AEs) and laboratory abnormalities.~   "
74861|NCT02077452|"~     The objectives of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2~     diabetes mellitus.~   "
74862|NCT02077439|"~     The goal of this study is to determine robotic hand system is more effective than~     conventional physical and occupational therapy at promoting functional recovery of the~     affected arm in subjects after stroke.~   "
74863|NCT02077426|"~     The aim of this study is to determine whether heart failure patients can tolerate a~     four-weeks of a new exercise training regimen that targets peripheral tissues (Regional~     Specific Training Stimulus-RSTS) and has been show to produce significant benefits in~     aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing~     functional independence.~   "
74864|NCT02077413|"~     The overall goal of this study is to establish a new pre-rehabilitation program in the~     prevention of muscle injury in the legs of healthy people serving in the military and~     injured individuals with muscle wasting following leg injuries. The specific goals include:~     1) the amount of exercise that causes injury to healthy muscle in the lower leg of healthy~     people; 2) what is the effect of an intervention (pre-rehabilitation program) on decreasing~     how easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of~     exercise causes injury to muscle that has recently been injured and is recovering and 3b)~     the effect of the new pre-rehabilitation program on the muscles of the lower leg when the~     muscle has recently been injured and is still recovering.~      For the first goal, the investigators will determine how easily the muscle can get injured~     from a specific exercise in 6 healthy, conditioned men and women. Participants will perform~     different amounts of exercise with the lower leg muscles to see how easily the muscle can be~     damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs~     with the different levels of exercise. For the second goal, the investigators will examine~     the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged~     from the exercise we did in the first goal. The investigators will invite healthy people to~     participate in this goal. The investigators will use MRI, blood markers, and pain as ways of~     assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising~     and 10 who do not do the new program. The third goal will focus on a) determining how easily~     muscle gets injured that has recently recovered from some trauma (5 people will participate~     in this part of the third goal), and b) determining how a pre-rehabilitation program~     decreases how easily a muscle that has just recovered from trauma gets injured from exercise~     (10 people will participate in this part of the third goal).~   "
74865|NCT02077400|"~     Fingertip amputation is a common injury. Considerable controversy exists as to whether~     prophylactic antibiotics are necessary for this injury. The investigators goal was to~     compare the rate of infections among subgroups with and without prophylactic antibiotic~     treatment. The study hypothesis was that infection rates were similar in the two groups.~   "
74894|NCT02077023|"~     The purpose of the study is to estimate the contemporary prevalence of cardiovascular~     diseases in the United Kingdom (UK) and to describe the incidence and prevalence of stroke,~     mini stroke (TIA), Heart Attack (MI), deaths and interventions repairs for carotids and~     occlusive arterial disease in a large population. This study will also allow us to obtain~     reliable information on the age- and sex-specific relevance of tobacco and alcohol~     consumption, obesity, diabetes and blood pressure as risk factors for different~     cardiovascular diseases. By following up a large group of participants for 5 years, we will~     be able to estimate the annual risk of stroke and other CVD events associated with~     asymptomatic carotid artery stenosis and atrial fibrillation.~   "
75237|NCT02072551|"~     The main objective of this study is to evaluate Beta cells in patients with a neonotal~     diabetes linked to a genetic abnormality Metabolic caracteristics will described using a~     transversal cohort study.~   "
74866|NCT02077387|"~     Today's environment provides many hedonic stimuli that promote consumption of unhealthy~     energy-dense snack foods. It is widely recognized that a systems approach is required to~     deal with this complex problem. However, individuals, particularly children, also need to~     develop the personal capacity to deal with tempting stimuli and inhibit responses to these~     energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level~     executive functions, particularly inhibitory control, which is needed to counterbalance~     impulsive behavior and is crucial for growth and development. We have chosen to focus on~     developing inhibitory control in preschool-age children because executive~     functioning/inhibitory control and eating habits are developing at this time. Among~     preschool-age children, inhibitory control is fostered through social play-based curriculums~     and has been found to be related to greater school readiness and academic skills. Therefore,~     the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind~     program, to promote greater inhibitory control skills in preschool children and decrease~     consumption of energy-dense snack foods. In Phase I, we will develop and pilot a Child~     Inhibitory Control Play-based Program (CHIC Play) among children age 4- to 6-years old. We~     will adapt the learning tools used in the Tools of the Mind curriculum and employ~     naturalistic play scenarios, drawings (visual support), and games to teach children to~     inhibit their responses to energy-dense snack foods. Once developed, we will test the~     efficacy of CHIC Play in the preschool setting. Parent groups will also be conducted to~     support the adoption of these skills at home. The primary outcome of interest is caloric~     intake and age- and gender-adjusted percent of daily caloric intake as measured by the~     Eating in the Absence of Hunger (EAH) free access procedure and a snack time procedure.~     Inhibitory control skills will also be measured using executive functioning tasks.~     Feasibility and acceptability of this program will be determined from parent, child, and~     teacher surveys. The purpose of this study is to develop a new innovative method of~     decreasing energy-dense snack food consumption by promoting the development of inhibitory~     control or impulse control. If successful, this program has the potential to play a role in~     the treatment and prevention of childhood obesity.~   "
74867|NCT02077374|"~     The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to~     placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and~     with abnormal liver tests~   "
74868|NCT02077361|"~     A project has been developed in Edmonton, Alberta, Canada to enable male patients with~     choroideremia to access a clinical trial that replaces the defective gene with a normal~     copy. This experiment is designed to show that the transfer of a normal copy of the gene to~     the eye is not only safe but may improve the sight of patients. Only Canadian subjects who~     meet criteria will be recruited.~   "
74869|NCT02077348|"~     Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these~     patients are 100% dependent on insulin substitution to survive.~      Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal~     muscle-tissue and - adipose-tissue.~      Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte~     derangement, ketosis and thus eventually ketoacidosis.~      Insulin signalling pathways are well-known.~      Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and~     preservation of protein during fasting. GH (in concert with lack of insulin) induces~     lipolysis during fasting. It is not known how GH exerts its lipolytic actions.~      The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different~     states in patients with DM I.~      And to test whether ATGL-related lipolysis in adipose tissue contributes to the development~     of ketosis.~        1. Good glycemic control~        2. Lack of insulin (ketosis/ketoacidosis)~        3. Good glycemic control and GH injection~   "
74870|NCT02077335|"~     The purpose of this study is to determine the clinical efficacy and toxicity of High-dose~     rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk~     prostate cancer.~   "
74871|NCT02077322|"~     Functional endoscopic sinus surgery (FESS) is the best method of surgically treating~     patients who suffer from sinus disease. Synechiae formation in the nose is the most common~     complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal~     surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage.~     Spacers are often inserted during surgery between nasal mucosal surfaces to prevent~     synechiae. The aim of this study is to see if a silastic spacer is more effective at~     reducing the formation of synechiae after sinus surgery than a merocel spacer.~   "
74872|NCT02077309|"~     Examination of the effect of Linagliptin versus placebo for 6 months on vascular~     inflammation of the carotic artery and on abdominal adipose tissue inflammation in patients~     with diabetes mellitus type 2. The effect will be assessed by FDG-PET scan.~      Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will~     be assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood~     samples.~   "
74873|NCT02077296|"~     Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy~     responders from non-responders and to individualize the treatment regime. Various cytokines~     play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines~     might influence treatment response. Various cytokines are abnormally expressed in colorectal~     cancer patients, are associated with colorectal cancer or determine response to~     chemoradiotherapy. Therefore the investigators want to investigate whether levels of~     circulating cytokines could predict response to preoperative chemoradiotherapy in patients~     with rectal cancer.~      Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines~     in the blood of rectal cancer patients may predict the response to preoperative~     chemoradiotherapy.~      Study design: This study is an explorative clinical pilot study in which the investigators~     will collect 4 ml of blood from a selection of rectal cancer patients during a regular~     venipuncture before, during and after preoperative chemoradiotherapy and before and after~     surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from~     the resection specimen using multiplex immunoassays. Plasma cytokine measurements will be~     linked to pathological response to identify which cytokines and corresponding levels can~     predict response to preoperative chemoradiotherapy for patients with locally advanced rectal~     cancer. Furthermore, blood plasma cytokine measurements before and after surgery will be~     compared to evaluate the effect of tumour resection on the immune response. In addition,~     preoperative blood plasma cytokine levels will be compared with cytokine levels in normal~     and tumour tissue to test whether circulating cytokine levels are representative for tissue~     cytokine levels.~      Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma~     eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total;~     fractions of 1.8-2 Gy) and surgery.~      Country of recruitment: The Netherlands~   "
74874|NCT02077283|"~     NAFLD(non-alcoholic fatty liver disease, NAFLD) is a common liver disease with a high~     morbidity which seriously influence people's health. In clinical, there are two major~     Traditional chinese medicine(TCM) patterns which are the pattern of liver depression and~     spleen deficiency and pattern of damp-heat in the interior, According to TCM patterns,~     the treatment is effective, but not used worldwide. While the development of metabonomics~     provides a tool to investigate the correlation of TCM patterns and metabonomics which will~     promote the further development of TCM.~      Currently researches on NAFLD patterns based on metabolomics were limited. Our study was~     undertaken to investigate the correlation of TCM patterns and metabonomics, to evaluate the~     application of urinary metabonomics in NAFLD: whether it can be used in TCM patterns~     auxiliary classification of NAFLD. In addition, the investigators also aim to discover novel~     biomarkers for the noninvasive early diagnosis of nonalcoholic fatty liver disease (NAFLD).~      In this study, urine samples from humans of three divided groups (healthy controls, the~     group of liver depression and spleen deficiency pattern and group of damp-heat in the~     interior pattern) were collected, then 4℃, 15 min 3000 rpm centrifuged and - 80℃~     cryopreserved. The metabolic profile changes were analyzed by Gas Chromatograph-Mass~     Spectrometer(GC/MS) with principal component analysis (PCA), partial least~     squares-discriminate analysis (PLS-DA) and orthogonal partial least squares-discriminate~     analysis (OPLS-DA). Furthermore, biochemical examination were also carried out to compare~     among these three groups.~      Base on literature survey, the investigators inferred that there should be metabolic~     differences between the two patterns of NAFLD. If the investigators hypothesis is correct,~     the investigators can find different metabolites which can be used discriminate between~     NAFLD and healthy population, different patterns through urinary metabonomics.~      The results will be attractive which mean a lot: it will prove the importance of the four~     diagnosis methods of TCM used in differential analysis by metabonomics; it will validate the~     classification of TCM syndromes is scientific; it will shed light in the study of TCM~     syndromes; it will find biology markers to help diagnosis, treatment and pattern~     discrimination.~   "
74876|NCT02077257|"~     This is a 12-week, randomized, open-label,,multicenter, Phase IV study exploring LDL-C~     lowering efficacy of Rosuvastatin 20 mg/d compared to 10 mg/day Chinese ACS patients.The~     Randomized Treatment Period is preceded by a 24hours Screening Period. The study flow chart~     (Figure 1) depicts the 2 periods which comprise the study. These periods are described as~     follows:~        1. Screening Period (Day -1 through Day 1) This period consists of Visits 1 and 2.~          Subjects entering the Screening Period are required to meet the inclusion criteria. All~          subjects will be instructed to follow the current TLC(therapeutic lifestyle~          change)dietary guidelines for the duration of the trial.~        2. 12-week Randomized Treatment Period (Day 1 through Week 12) This period consists of~          Visits 2, 3, 4, and 5. Eligible subjects will be randomized at Visit 2 to each~          treatment group: Rosuvastatin 20 mg orRosuvastatin10 mg. Treatment will be administered~          once daily for 12 weeks.~      A total of 450valid subjects in each of the Rosuvastatin arms are required, in order to test~     the hypothesis of superiority for comparison of LDL-C levels between Rosuvastatin20 mg and~     Rosuvastatin10 mg(see Section 6.1 for more details).~      The Study visit schedule(Table 2) indicates the number and timing of the planned visits. The~     visit schedule must be within time window. At the final visit, it is the responsibility of~     the investigator to ensure the subject is offered an selected appropriate type of~     lipid-lowering therapy.~      Scheduled Visit3,4,5 will have a visit window of ±2 days. Subjects who attend a clinic visit~     without fasting (at least 12 hours) should be asked to return within 2 days for another~     clinic visit after fasting for at least 12 hours.~   "
74877|NCT02077244|"~     To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS)~     symptoms and improve quality of life after an intensive care unit (ICU) stay.~      Secondly:~      Investigate level of psychological distress, quality of life, hope and work participation in~     ICU patients after an ICU stay and factors associated with these outcomes.~   "
74878|NCT02077231|"~     Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular~     surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to~     search for new drugs for therapy. The investigators hypothesized that the artificial tears~     containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in~     common use and had already been tested in animals.~   "
74879|NCT02077218|"~     This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in~     diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell~     transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or~     blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart)~     and patients who have undergone a stem cell transplant are at an especially high risk for~     CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from~     different angles. The pictures are created by a computer linked to an x-ray machine.~     Studying samples of blood from patients who have undergone a stem cell transplant in the~     laboratory may help doctors identify and learn more about biomarkers related to CAD. Using a~     CT scan in combination with biomarker analysis may be a better and less-invasive way to~     diagnose CAD.~   "
74880|NCT02077205|"~     Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders~     is evaluated in a routine care setting to evaluate the efficacy of the intervention.~     Children and adolescents receive manualized Cognitive Behavioral Therapy for anxiety~     disorder.~      It is expected, that the intervention will result in less anxiety / lower scores on the~     primary and secondary outcome measures.~   "
74881|NCT02077192|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in~     treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 2~     year period.~   "
74882|NCT02077179|"~     Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and~     Action Plan state that women's heart health is a key national priority; it should be~     addressed through improving heart health awareness and prevention, and reducing care~     inequities for women in general and younger women in particular. The investigators have~     developed an innovative and interactive mobile website based postpartum lifestyle~     modification program (regular physical activity and nutritional guidance), based on~     established national guidelines, to improve heart disease risk factors in women. The~     investigators will conduct a trial to determine if the mobile website based lifestyle~     modification program can be maintained and reduces a collection of risk factors, which~     occurring together, greatly increases the risk of developing heart disease. The~     investigators hypothesize that the interactive mobile website directing regular physical~     activity and personalized nutritional guidance, compared to standard postpartum care, will~     be motivational and result in a reduced modified metabolic syndrome z score at 8 months~     postpartum among the intervention group.~   "
74883|NCT02077166|"~     This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in~     combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse~     Large B-Cell Lymphoma (DLBCL) not eligible for transplant.~   "
74895|NCT02077010|"~     Patients with end stage heart failure have significant symptoms (including fatigue and~     shortness of breath) which prevent them from being able to perform most activities of daily~     living. Milrinone is one of the inotropic medications that has been studied and used in the~     treatment of end stage heart failure. End stage heart failure patients awaiting a heart~     transplantation often have to be maintained on IV milrinone 24 hours a day through a chronic~     IV line. Two problems arise with this therapy. First, the IV line itself creates an~     opportunity for infection and blood clots, in addition to interfering with patient's quality~     of life. Second, patients may be exposed to higher levels of milrinone when given IV than~     are necessary for maintaining their heart's function.~      The investigators goal is to show that inhaled milrinone is equivalent to standard of care~     IV milrinone in improving heart and lung pressures in end stage heart failure patients (who~     respond to milrinone therapy) in a prospective, randomized, controlled clinical trial.~     Patients who are sent for a right heart catheterization procedure by their cardiologist to~     determine if they require milrinone while awaiting heart transplantation will be randomly~     chosen to be in the continuous IV milrinone group or the inhaled milrinone group after~     agreeing to participate in this study. Patients in the inhaled milrinone group will receive~     6mg in 6ml of fluid inhaled by a vibrating mesh nebulizer every 4 hours. Patients in the IV~     arm will receive a constant IV infusion rate. Both groups will have a repeat right heart~     catheterization procedure an average of 48 hours after milrinone initiation to evaluate~     their response to milrinone. Afterward, all patients that respond will be placed on the~     standard of care IV milrinone for the duration of their therapy, as directed by their~     cardiologist.~   "
75121|NCT02074059|"~     The primary objective of this study is to evaluate the safety and tolerability of~     aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating~     inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal~     continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS),~     compared to neonates receiving nCPAP alone.~   "
74884|NCT02077153|"~     Reminiscence group therapy is a brief and structured intervention that has been shown to be~     effective for improving well-being among older adults. Reminiscence helps accepting the~     ageing process by solving unresolved issues and past losses; the group setting empowers the~     efficacy of the process by giving back to elderly a way to manage their skills in a wider~     setting and interact with other people. The sharing of memories reinforces the identity~     through active tasks, preparing individuals to cope with the final part of the life.~     However, considering reminiscence interventions for older populations, controlled trials~     adopting better inclusion/exclusion criteria, standardized measures, and different~     conditions for comparing the effect are needed.~      According to this premise, the trial presents the design of a randomized controlled aimed at~     comparing group reminiscence therapy with a group recreational activity in a older~     population. It includes two groups of approximately 20 hospitalized elderly: (1) the~     Experimental Group, (2) the Control Group. Participants included in the Experimental Group~     will receive a group reminiscence therapy of six sessions, while the Control Group will~     participate in a recreational group discussion. Between design with repeated measures will~     be used to evaluate changes in self-reported outcome measures of depressive symptoms,~     self-esteem, life satisfaction, quality of life across baseline, post-intervention and three~     months post-intervention.~      What the investigators would like to show with the present trial is the efficacy of a group~     reminiscence intervention in a hospitalized population of older adults: focusing on specific~     past events and re-living them in a group environment may enhance the self-esteem and~     quality of life better than a simple group discussion.~   "
74885|NCT02077140|"~     The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and~     women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to~     determine the analgesic efficacy of MDT-10013 compared with standard of care in the~     treatment of acute postoperative pain after subjects undergo bunionectomy.~   "
74886|NCT02077127|"~     The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood.~     Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated~     with diabetic microvascular or macrovascular complications. However, the relationship~     between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains~     controversial. In the present study, we evaluated the association of a single nucleotide~     polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular~     edema (DME) in Chinese population from Southern China with type 2 diabetes.~   "
74887|NCT02077114|"~     The purpose of the study is to assess whether a vaccine containing a small fragment of the~     protein IDO, which may be present in cancer cells and cells of the immune system, is safe to~     use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant~     melanoma that has metastasized.~   "
74888|NCT02077101|"~     The main objective of the study is to assess the acceptability of a future therapeutic~     vaccine against HIV in patients living with HIV-1.~      Secondary objectives concern the validation of a specific questionnaire for self-perception~     and acceptability of therapeutic vaccination against HIV-1 (RAVVIH), the development of a~     composite score for acceptability based on this questionnaire, and the analysis of critical~     factors related to: representations of vaccination in general, representations of~     therapeutic vaccination specific to HIV, perception of disease severity, health-related~     quality of life, doctor-patient relationship.~   "
74889|NCT02077088|"~     Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead~     to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of~     allergy in family~   "
74890|NCT02077075|"~     This research is collecting data to determine the benefits of a web-based wellness program~     designed to improve the health and well-being of individuals in the workplace. Participants~     will be invited to participate in a web-based Healthy Weight Program. The program is~     designed to optimize health and wellbeing by promoting physical activity and healthy eating.~   "
74891|NCT02077062|"~     Prospective non-randomized trial to study expression of mediators of post hepatectomy liver~     regeneration (PHLR) and compare with a non-hepatectomy group: a pilot study Background :~     Experimental studies using post hepatectomy animal models have been used to study the~     mechanism of liver regeneration. Hepatectomy for various diseases and living donor liver~     transplant provide a good human model to study in vivo mechanism of liver regeneration.~     These studies are necessary for the clinical application of the knowledge obtained by animal~     experiments and will guide further research to develop new modalities for the management of~     hepatic failure, cirrhosis and cancer.~      Null hypothesis: Expression of mediators of post hepatectomy liver regeneration (PHLR) is~     not different between hepatectomy (study group) and non hepatectomy group (control group).~      Aim: To study the mechanism of post hepatectomy liver regeneration(PHLR) and compare~     expression of mediators of PHLR between hepatectomy (study group) and a non-hepatectomy~     group (control group).~      Patient and method: This prospective non randomized trail will be conducted on two group of~     patients- hepatectomy (Study) group and non-hepatectomy (control) group and minimum 10~     consecutive adult (18 year or more) patients will be recruited in each group according to~     inclusion and exclusion criteria given below. Informed consent will be obtained from the~     patients in both the groups. Peripheral (from a forearm vein) venous blood (6 ml) will be~     collected a day before surgery and at different intervals after surgery (day 1, day 3,7, 2~     weeks, 6 weeks and 6 months). A small branch of portal vein will be cannulated a 20 gauge~     intravenous catheter for measurement of portal pressure and collection of portal venous~     blood (6 ml) at the start (after entry inside the abdomen) and at the end (before closure of~     the abdomen). Patients in hepatectomy (study) group will undergo trucut (needle) biopsy from~     the remnant liver. Mediators of liver regeneration will be measured by standard methods in~     blood samples from both groups. The liver tissue from study group will also be analysed for~     factors related to initiation of PHLR.~   "
74892|NCT02077049|"~     The main objective of this study is to determine whether elderly people in rehabilitation~     setting show higher adherence to self-training when using computer-based-learning games~     (i.e. the so called serious games) than when performing conventional exercises. Secondly the~     study explores to which extend balance and mobility performances vary according to the mode~     of self-training.~      The primary study hypothesis is that elderly people practice longer and more frequently with~     serious games than with a conventional exercise booklet. The secondary hypothesis is that~     patients experience a significant higher improvement in their balance capacity by using~     serious games compared to patients performing conventional exercises.~   "
74893|NCT02077036|"~     The overall aim of the study is to investigate the effect of a new, non-pharmacological~     method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the~     use of medications with potentially serious side effects in patients with this disease.~   "
74931|NCT02076542|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and sports. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables~     are: diabetes-related distress, health-related quality of life, depressive symptoms,~     self-care behavior, and glycemic control.~   "
74896|NCT02076997|"~     Pediatric cancer patients are being asked to take part in this study who have a cancer that~     is treated with high doses of the drug methotrexate (MTX). In addition, these patients have~     either had significant side effects to methotrexate in the past or their doctor thinks that~     they are at high risk for side effects from receiving methotrexate. Methotrexate is a~     cancer-fighting drug that is very important in the treatment of leukemia.~      In this study, investigators are testing a new method of giving high dose methotrexate to~     cancer patients which may reduce the chances that the level of methotrexate in the blood is~     too high. When the levels are too high this is thought to lead to an increase in side~     effects. Side effects are unintended and unwanted results of treatment.~      The initial ordered amount of methotrexate and the period over which methotrexate is given~     will not change from the current standard of care (meaning what is usually done by doctors,~     and would likely be done if the patient was not on this study). This study is testing a new~     method of monitoring and potentially adjusting the final amount of methotrexate that the~     patient will end up receiving based on levels of methotrexate in the blood in the first 24~     hours in order to try to prevent side effects in patients with a previous history of side~     effects from methotrexate or who are at high risk for having side effects.~      On this study the investigators will check methotrexate levels in the blood 2 hours after~     the patient starts receiving the drug and the investigators will lower the dose of~     methotrexate if needed. Investigators will do the same thing again 6-8 hours later.~      Investigators will also collect an optional blood sample from the patient because the~     investigators want to study how genetic (DNA) differences are involved in how the body~     processes methotrexate.~   "
74897|NCT02076984|"~     Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies~     and a recent meta-analysis have reported encouraging results and recurrence rates similar to~     open repair. The choice of the mesh and fixation methods is of paramount importance during~     laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for~     laparoscopic approach represent the first choice in several studies, due to the~     biomechanical properties and the optimal integration into the abdominal wall. No data with~     statistical relevance exist on the choice of fixation methods.~      Primary end point of the present Italian multicentric prospective randomized trial is to~     evaluate the safety and effectiveness of two different tacks to fix the lightweight~     polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic~     spiral tacks (Protack™) vs absorbable U shaped tacks (Securestrap™)~      Design of the Study: 200 patients with ventral hernia will be randomized into two groups:~      Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack;~     Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by~     Securestrap.~      Blind randomization will be guaranteed by an on-line software with specific key access for~     every surgical unit participating in the study. Patients demographics and characteristics,~     preoperative studies, intraoperative and postoperative results and complications, as well as~     scheduled follow-up will be recorded and uploaded to the database. Data represented by~     continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data~     will be expressed as geometric mean +/- 95% confidence interval. Data representing low~     incidence events will be expressed as number and percentage of occurrence for each group.~     Statistical significance for all analyses will be indicated by a p value of 0.05 or less.~   "
74898|NCT02076971|"~     The purpose of this study is to determine the sensitivity and specificity of QuantiFeron®~     and ImmuKnow® in combination for early detection of patients who will develop CMV infection~     in lung transplant patients with CMV-positive serology (R+) prior to transplant.~   "
74899|NCT02076958|"~     The aim of the proposed project is to identify an optimal implementation strategy using a~     set of evidence-based interventions that aim to increase early detection of breast,~     prostate, and colorectal cancer among African Americans as a model. These three~     interventions will be packaged and interwoven into a single branded project, Project HEAL~     (Health through Early Awareness and Learning) which will be delivered through trained~     Community Health Advisors (CHA) in African-American church settings. The implementation and~     sustainability will be evaluated using the RE-AIM Framework. Fourteen African American~     churches in Prince George's County, MD will be randomized to a traditional classroom~     training approach or an online training approach, in which the CHA training approach and~     level of technical assistance is varied (in-person classroom training of CHAs +~     monitoring/evaluation + technical assistance and training vs. online training of CHAs +~     monitoring and evaluation only, respectively). By varying the training methodology and level~     of technical assistance, we will be able to determine what level of technical assistance~     leads to successful implementation and sustainability. We will also identify church~     organizational capacity characteristics that lead to successful implementation and~     sustainability. The specific aims of this research are to: (1) Package the three~     interventions into a single branded project (Project HEAL), develop a local cancer screening~     resource guide, and pilot test the materials and training. (2) Implement Project HEAL in 14~     churches in Prince George's County, Maryland. We will evaluate the implementation outcomes~     involving treatment fidelity and identify church organizational capacity characteristics~     that led to successful implementation. We will compare the two implementation strategies~     (traditional vs. online) to determine the optimal level of technical assistance necessary~     for successful implementation. (3) Evaluate the sustainability of Project HEAL over a~     two-year period of time. We will identify church organizational capacity characteristics~     that led to sustainability, and compare the two implementation strategies (traditional vs.~     online) to determine the optimal level of technical assistance for successful~     sustainability.~   "
74900|NCT02076945|"~     Background Between 25 and 55% of diabetic patients develop neuropathy secondary to~     hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool~     to detect the presence of neuropathy prior to block performance, by measuring the~     cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a~     distance of 3 cm above the medial malleolus has an optimal threshold value for~     identification of diabetic sensorimotor polyneuropathy.~      Animal data showed that duration of sciatic nerve block with local anesthetics is longer in~     diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve~     blockade in humans with diabetic sensorimotor neuropathy are unknown.~      Aim The aim of this study is to compare duration of analgesia and other characteristics of~     an ultrasound-guided popliteal sciatic nerve block between diabetic patients with~     neuropathy, diabetic patients without neuropathy and non-diabetic patients without~     neuropathy, based on the ultrasound-measured cross-sectional area of the posterior tibial~     nerve.~      Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of~     analgesia lasting 50% longer than patients without neuropathy.~      Methods This will be an observational study on diabetic and non-diabetic patients, with and~     without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the~     posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2)~      All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of~     lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the~     sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block~     success will be confirmed by loss of sensation to pinprick in the distribution of the common~     peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure~     will be completed by a saphenous nerve block. Postoperative pain management will be~     standardized.~      Pain and block-related endpoints will be collected such as onset time of action of sensory~     and motor blockades, duration of analgesia, pain scores and opiates consumption among~     others.~      Relevance Defining the duration of analgesia in case of diabetic neuropathy will help~     regional anesthesiologists to better define the type and doses of drugs that will be~     injected and to better prescribe the postoperative multimodal analgesic treatment.~   "
74901|NCT02076932|"~     The purpose of this study is to determine if physical exercise reduces the adverse changes~     in adipose tissue metabolism and insulin sensitivity that occurs in women during the~     menopausal transition.~   "
74902|NCT02076919|"~     The purpose of this first-in-human study is to assess the local ocular and systemic safety~     and tolerability of LHA510 eye drops when administered at various concentrations and dosing~     frequencies.~   "
74903|NCT02076906|"~     The purpose of this study is to determine if Magnetic Resonance guided High Intensity~     Focused Ultrasound ablative therapy is safe and feasible for children with refractory or~     relapsed solid tumors.~   "
74912|NCT02076789|"~     This study has been designed to prospectively estimate long term complication rates~     (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD)~     replacement, with and without a planned transvenous lead addition for replacement or upgrade~     to a device capable of additional therapies; the study also evaluates the predictors of~     complications, the patient's management before and during the replacement procedure in~     clinical practice and the estimated costs related to the use of health care resources.~   "
74913|NCT02076776|"~     The purpose of this study is to gain a better understanding of how different types of~     exercise can help people after a stroke. The investigators want to study if different types~     of exercise will improve the use of arm and hand function after a stroke.~   "
74930|NCT02076555|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and social issues. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome~     variables are: diabetes-related distress, health-related quality of life, depressive~     symptoms, self-care behavior, and glycemic control.~   "
74904|NCT02076893|"~     Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over~     530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The~     postoperative period can be particularly painful. A recent clinical consensus acknowledges~     there is no standard analgesic protocol, and calls for further research comparing~     postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective~     as codeine with few reported side effects in a recent double-blinded, controlled trial~     conducted by the investigators at Children's Hospitals and Clinics (CHC), and it is~     currently being prescribed in the postoperative setting. However, despite its effectiveness~     for pain control, there were some children that continued to report pain during the 10-day~     follow-up period. In response, the investigators will conduct a randomized, double-blinded~     controlled trial to determine whether or not adding scheduled gabapentin to a scheduled~     tramadol + as needed (PRN) ibuprofen regimen provides better pain control than tramadol +~     ibuprofen PRN alone during the post-tonsillectomy period. Using a 10-day take-home diary,~     caregivers will be asked to record daily information about their child's postoperative pain~     and other core outcomes and domains as recommended in the recent consensus statement put~     forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical~     Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the~     efficacy and side effects associated with adding scheduled gabapentin to a postoperative~     pain management protocol in a pediatric population.~   "
74905|NCT02076880|"~     Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the~     gastric fundus. According to a recent randomized study, weight loss and resolution of~     diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but~     with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after~     sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2~     diabetic obese are available. An increase in post- absorptive levels of Glucagon-like~     Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic~     subjects mostly. The important caloric restriction in the early postoperative period indeed~     improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and~     hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to~     explore the early and late metabolic effects of sleeve gastrectomy in severely obese~     patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin~     sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with~     type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and~     whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be~     randomized to a 1-week caloric restriction period or no caloric restriction, immediately~     before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin,~     leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1~     week, 3 month, 6 month and 12 month after surgery.~   "
74906|NCT02076867|"~     The purpose of this study is to compare the effectiveness of Intensive Short-Term Dynamic~     Psychotherapy (ISTDP) plus Medical Care As Usual (MCAU) compared to MCAU for Somatic Symptom~     and Related Disorders (SSRD). Consenting patients presenting to the emergency department~     with suspected SSRD will be randomly allocated to receive either 8 weekly individual~     sessions of ISTDP or to an 8-week wait list followed by ISTDP. MCAU including emergency~     department and/or family doctor consultation is available throughout trial participation.~     The primary outcome measure is participant self-reported somatic symptoms at week 8.~   "
74907|NCT02076854|"~     The aim of this study is to pilot an innovative motivational text-message intervention for~     individuals with anorexia nervosa and subthreshold anorexia nervosa. Patients will receive~     personalized motivational text-messages as an adjunct to cognitive behavioral therapy (CBT).~     CBT will be provided to patients at no cost for the duration of the study. The investigators~     hypothesize that the text-messages will help increase motivation to change and kilocalorie~     intake and decrease eating disordered behavior.~   "
74908|NCT02076841|"~     To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS~     (Multiple Sclerosis) participants who have been switched - due to persistent tolerability~     issues, particularly injection problems - from a subcutaneous injectable disease-modifying~     treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly~     Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex~     Pen.~   "
74909|NCT02076828|"~     The aim of the present study was to compare the effectiveness of the different oral iron~     preparations in children with IDA.~   "
74910|NCT02076815|"~     The purpose of this study is determine whether Anagrelide Retard is non-inferior to~     anagrelide immediate release form in treatment of essential thrombocythemia.~      Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained~     increase in platelet counts above the normal value (> 450 x 109/L) and increased~     megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis.~      Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte~     development and maturation in humans, without affecting other cell lineages.~      Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide~     developed by AOP Orphan Pharmaceuticals AG. The rationale for developing this new~     formulation is based on the assumption of having a better tolerability while maintaining an~     efficacy comparable to that of the immediate release formulation.~      The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean~     platelet count measured by a central laboratory/centralized method at 3 time points during~     the maintenance phase.~   "
74911|NCT02076802|"~     The epidemic data shows that prehypertension is associated with cardiovascular disease, and~     heavy dietary salt intake could improve the developing of hypertension. We detected the risk~     factors of coronary atherosclerosis of prehypertensive patients with different levels of~     salt intake.~      The aim of this multicenter prospective, randomized controlled study is to evaluate regular~     physical exercise and salt diet effects on progression of coronary artery disease in~     patients with prehypertension.~   "
74928|NCT02076581|"~     It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to~     neurological injury. This makes it difficult to evaluate therapies that aim to reduce the~     effects of abnormal muscle tone. This research study will evaluate the feasibility of a~     clinician worn device to capture and quantify features of spasticity and dystonia.~   "
74914|NCT02076763|"~     This is an observational prospective study that will allow evaluating the clinical and~     laboratory parameters evolution of at least eight patients with AIP.~      This study will allow establishing a baseline for the evaluation of the eight patients that~     are planned to be included in a gene therapy clinical trial (AAVPBGD-AIP-001) for the AIP~     treatment using a rAAV5-AAT-cohPBGD expression.~      Patients fulfilling the study inclusion criteria will undergo a clinical and laboratory~     evaluation for a minimum of 6 months (with one inclusion visit, one final visit and at least~     two visits of follow up) up to a maximum of 24 months until their inclusion in the~     subsequent clinical trial.~      A complete evaluation of the clinical (symptoms and quality of life assessment) and~     laboratory (blood and urine) data will be collected.~   "
74915|NCT02076750|"~     The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is~     effective in correcting low vitamin D levels in children and adolescents with inflammatory~     bowel disease (also known as Crohn's disease and ulcerative colitis).~   "
74916|NCT02076737|"~     The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR~     VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal~     colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).~   "
74917|NCT02076724|"~     The purpose of this study is to compare two methods for reinforcement of the abdominal~     donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the~     abdominal donor-site is performed, after randomization, with either a porcine derived~     biological mesh or a synthetic mesh. The patient and the investigator is blinded.~      The aim is to identify the most optimal method for reinforcement of the abdominal donor-site~     and thereby contribute to fast and complete rehabilitation of women undergoing breast~     reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due~     to breast cancer, precursors to breast cancer or an increased risk of developing breast~     cancer and thereby following preventive removal of the breast tissue.~      The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal~     wall function, the donor site morbidity, the frequency of postoperative complications, the~     aesthetic appearance of the reconstructed breast and the abdominal wall and costs are~     evaluated.~   "
74918|NCT02076711|"~     Background - Aortic valve stenosis (AS) is the most common heart valve disease among adults~     in the Western world with a prevalence of 3 % in people older than 75 years of age. AS~     usually deteriorates over time leading to heart failure, with high mortality if aortic valve~     replacement (AVR) is not performed. Thus optimal timing of AVR is crucial, but can be~     challenging. Increasing life expectancy in our society will augment the therapeutic and~     socio economic impact of AS disease on our health care system. Therefore, new techniques for~     monitoring asymptomatic AS patients are needed. A potential approach is monitoring of LV~     myocardial efficiency (mechanical work/oxygen consumption). These measures have been~     suggested to be involved in the progression of non-valvular heart failure and closely~     related to prognosis, but never applied in a larger population of patients with AS. At~     present there are no recognized pharmacological treatments of AS. It is known that~     beta-blocker treatment in non-valvular systolic heart failure reduce heart rate, improves LV~     myocardial efficiency and reduces mortality. However, in patients with AS, the effects of~     beta-blockers are unknown.~      Hypotheses - Treatment with the beta-blocker metoprolol succinate in patients with~     asymptomatic moderate to severe AS has beneficial effects on LV myocardial oxidative~     metabolism, myocardial efficiency and contractile function.~      Objectives - To investigate if beta-blocker treatment in patients with moderate to severe,~     asymptomatic AS has beneficial effects on LV myocardial efficiency, contractile function and~     physical performance.~      Design - A randomized double blind placebo controlled intervention trial. 40 patients with~     asymptomatic AS will be randomized to either per oral metoprolol succinate (N = 20) or~     placebo (N= 20) for 22 weeks.~      Primary objective - Changes in myocardial efficiency~      Secondary objectives - Myocardial oxygen consumption, Myocardial perfusion at rest, LV~     myocardial function, LVmass, Aortic valve area and transaortic valve velocities, 6 minute~     walking distance, N-terminal prohormone of brain natriuretic peptide, Quality of life~     (estimated by Minnesota living with heart failure questionnaire), LV wall stress~      Methods - Patients will undergo echocardiography (resting and exercise), [11C]acetate PET~     and cardiac magnetic resonance imaging.~   "
74919|NCT02076698|"~     The main objective of the study is twofold:~        1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity~          at 1 year follow up.~        2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2~          years.~      The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the~     thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe~     crises) of the most severe seizures, in at least 50% of patients who have drug-resistant~     partial epilepsy; and should also improve significantly the quality of life through a gain~     of independence in activities of daily life, the possible recovery of functional abilities,~     recovery of social or professional activities.~   "
74920|NCT02076685|"~     To improve the treatment outcome in patients with tuberculosis and integrate the~     pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in~     re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis~     medication-induced hepatitis.~   "
74921|NCT02076672|"~     This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using~     a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate~     (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex~     extract from the artichoke plant as a chemoprevention agent.~   "
74922|NCT02076659|"~     Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of~     F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.~   "
74923|NCT02076646|"~     A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with~     Dacarbazine in patients with metastatic melanoma.~   "
74924|NCT02076633|"~     This Phase II study is an uncontrolled, multicenter, prospective study for patients with~     malignant melanoma of the skin in clinical stage III or stage IV M1a.~      Twenty Patients will be treated with a mixture of L19IL2 and L19TNF once weekly for up to 4~     weeks.~      The dose will be distributed among the lesions via multiple intralesional injections.~      The proportion of patients with complete response at week 12 will be calculated.~   "
74925|NCT02076620|"~     Prospective, open-label, non randomized, dose escalation study that will be conducted in~     sequential cohorts of patients.~   "
74926|NCT02076607|"~     Evaluate the correlation between the structural changes of fractures of the thoracic and~     lumbar spine burst type with clinical outcome of the treatment.~   "
74927|NCT02076594|"~     This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced~     (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for~     this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B).~     Randomization will be stratified by performance status (ECOG 0 or 1).~   "
74933|NCT02076516|"~     The purpose of this study is to evaluate the safety and effectiveness of the CORACTO®~     (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo~     lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native~     coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from~     2.5 to 4.0 mm in diameter < than 15 mm suitable for treatment with a single CORACTO® stent~     in a population of 100 patients.~   "
74934|NCT02076503|"~     Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment,~     accurate staging of the disease at the time point of diagnosis is important. The objective~     of this study is to evaluate the diagnostic potential of a combined PET/MR examination for~     risk assessment and detection of lymph node metastases. The overall aim of the project is to~     improve the investigators ability to provide individually tailored treatment to prostate~     cancer patients.~      The study will include 32 men with high-risk prostate cancer, who are eligible for radical~     prostatectomy. Informed consent is a requirement for inclusion in the study.~   "
74935|NCT02076490|"~     The overall aim of this randomized controlled study is to investigate the effectiveness of~     mirror therapy supported by telerehabilitation on the intensity, duration and frequency of~     phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor~     exercises without a mirror in patients following lower limb amputation.~   "
74936|NCT02076477|"~     This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage~     iv lung cancer.~   "
74937|NCT02076464|"~     The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce~     eating disorder outcomes in college-age women.~   "
74938|NCT02076451|"~     This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability,~     identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its~     properties in subjects with advanced solid tumors or lymphomas.~      Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose~     Expansion) in subjects with solid tumors or lymphomas.~   "
74939|NCT02076438|"~     The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus~     GG) along with antibiotics can help decrease the occurrence of diarrhea caused by~     antibiotics as well as Clostridium difficile Diarrhea.~   "
74940|NCT02076425|"~     Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a~     sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL)~     control after which participants will receive the active treatment. PCIT-ED is an expansion~     of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive~     disorders. To address early disturbances of mood and affect, a novel ED module was added~     based on empirical data in emotion development. The ED module targets parent emotion~     learning skills with the goal of training the parent to serve as a more effective emotion~     teacher and coach to the child. The goal of the ED module is to enhance the child's capacity~     for emotion recognition and regulation or emotional competence. In order to test the~     efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and~     moderators of treatment response participants will complete comprehensive pre-, interval,~     and post-assessments.~      Preschoolers over 3 will be offered the option of enrolling in an add-on~     electroencephalography and magnetic resonance imagery study, to investigate neural changes~     associated with PCIT-ED.~      Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show~     significantly increased rates of remission, greater reductions in MDD symptoms, and~     decreases in impairment; and will show significantly greater increases in emotional~     competence measured by the ability to accurately identify emotions in themselves and others~     and the ability to effectively regulate intense emotions. Compared to those on the WL,~     parents who undergo PCIT-ED will show significantly greater increases in emotion skill~     learning and reductions in MDD symptoms and parenting stress.~   "
74941|NCT02076412|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).~   "
74942|NCT02076399|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).~   "
74943|NCT02076386|"~     DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir~     as part of an antiretroviral combination therapy in routine daily practice in Germany. The~     primary study objective is a descriptive characterization of the frequency of therapeutic~     monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine~     daily practice in Germany.~      The study is designed to enroll approximately 400 patients. There are no protocol-mandated~     visits or procedures associated with the study. Each patient is expected to participate for~     a maximum of 3 years or until premature discontinuation (i.e., discontinuation of~     dolutegravir, due to death, withdrawal of consent, lost to follow-up).~   "
74944|NCT02076373|"~     The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the~     effect of intravenously administered recombinant human erythropoietin (Epo) as compared to~     placebo in preterm infants with brain damage on neurological development until five years od~     age.~   "
74945|NCT02076360|"~     This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical~     trial at one institution evaluating the use of a preoperative patient education video as an~     adjunct to preoperative counseling on patient-centered outcomes.~      The aim of this study is to determine the impact of a preoperative patient educational video~     as an adjunct to the routine preoperative visit on patients' preparedness for surgery,~     perception of time spent with their healthcare team, and ultimately their satisfaction after~     surgery. The aim of this video is not to limit the doctor patient interaction (as all~     patients will still be granted their pre-allotted 30 minute visit with the physician~     regardless of their intervention allocation) but rather to augment the visit with additional~     educational information in an attempt to optimize the visit.~      Objective:~      A. Primary Aim(s):~      • To determine if patients feel more prepared for surgery with addition of preoperative~     patient education video~      B. Secondary Aim(s):~        -  To determine if addition of preoperative patient education video correlates with~          improved patient satisfaction after surgery~        -  To determine if patients' perception of time spent with healthcare team in preparation~          for surgery increases with addition of patient educational video~        -  To determine if actual patient-physician time spent counseling differs between groups~        -  To determine if patient preparedness is correlated with objective surgical outcomes~        -  To determine if patient preparedness is correlated with patient symptom improvement~          scores after surgery~      Hypothesis:~      The addition of a preoperative patient education video enhances patient preparedness for~     surgery, increases perception of the amount of time patients spend with healthcare team, and~     improves patient satisfaction.~   "
74946|NCT02076347|"~     The purpose of this project is to compare two pharmacist-led population management~     strategies designed to increase the rate of appropriate monitoring of vitamin B12 and serum~     creatinine for patients taking metformin.~   "
74947|NCT02076334|"~     To examine the influence of compression garments manufactured with Far-Infrared technology~     on exercise performance during and after repeated eccentric isokinetic muscle actions of the~     leg extensors.~   "
74948|NCT02076321|"~     Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications~     for providing pain control in children with fractures or those who have surgery to correct~     bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to~     suggest that these types of medications can adversely affect bone healing in adult patients~     with broken bones or those having spine fusion surgery. There is little data with regard to~     how these medications effect bone healing in children. With this project, the investigators'~     goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to~     demonstrate that these medications adequately control pain in children with broken bones or~     those who have had an osteotomy.~   "
74949|NCT02076308|"~     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly~     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively~     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and~     disability. These patients need early and regular rehabilitation to regain their function~     and prevent unnecessary complications such as contracture and disuse atrophy. Proper~     rehabilitation is important but the challenge is also great. However, rehabilitation~     training is a very labor-intensive task in which one to one treatment is essential and that~     will restrict the number of patients served. Moreover, patients receiving home programs are~     difficult to supervise, resulting in reduced training effect and delayed functional~     recovery. In order to reduce related cost (including time, personnel, facilities, and~     expense, etc.) of rehabilitation in hospitals or clinics, this Robot research team had~     developed a prototype of upper-limb exoskeleton rehabilitation robot and its related~     technology and human-robot interaction. This robot is used to serve the rehabilitation need~     of those patients suffering from upper extremities dysfunctions and also can provide careful~     designed therapeutic program of upper limbs including shoulder and elbow joint exercises.~     Its control software also provides a therapeutic management system with intelligence and~     ergonomic consideration. This work was funded by National Taiwan University Hospital (NTUH)~     since 2008 and has applied for both the U.S. and Taiwan (ROC) patents, where the latter has~     been approved in Nov. 2011. The clinical trial was firstly approved by Research Ethics~     Committee B of NTUH in 2009 and finally approved by Department of Health (DOH) in April~     2011. This team had completed the clinical trial for healthy subjects and pre-clinical trial~     for stroke patients. Based upon this experience an innovative and intelligent SMART Robot~     Rehabilitation System for Frozen Shoulder Syndrome is proposed to prove its safety,~     efficacy, and cost-effectiveness.~   "
74950|NCT02076295|"~     Mild cognitive impairment and dementia are frequent non-motor complications of moderate to~     advanced Parkinson's disease. Brain positron emission tomography (PET) study findings~     confirm post-mortem evidence that cholinergic loss is related to cognitive impairment in~     Parkinson's disease. However, current cholinergic augmentation therapy is not always~     effective and it should only target those Parkinson's disease patients who have evidence of~     cholinergic system impairment. The objective of this study is to study the association of a~     particular subtype of cholinergic receptors, so-called nicotinic acetylcholine receptors,~     with cognition in Parkinson's disease using a novel PET marker of cholinergic system~     integrity.~   "
74951|NCT02076282|"~     Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In~     order to irradiate as precise as possible, and in order to evaluate the effect of radiation~     treatment, it is important to depict the lung tumor and the lymph node metastases as~     accurate as possible. Currently, radiation oncologists use PET-CT for this purpose. However,~     PET-CT does have its drawbacks, and partly because of this, large volumes are irradiated in~     current treatment.~      The investigators believe that MRI can be used to improve depiction of the tumor and lymph~     nodes and of their motion. However, there is currently no MRI protocol available which is~     aimed at improving radiotherapy.~      In this study, the investigators want to select the optimal MRI settings for depiction of~     the lung tumor, the lymph node metastases and their movement.~      The investigators plan to do this by first examining 10 healthy volunteers, followed by 20~     patients with non-small cell lung cancer.~   "
74952|NCT02076269|"~     This purpose of this study is to obtain inhalation profiles in subjects with very severe~     Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational~     medicinal product. Each subject will attend the clinic on 2 occasions, initially for a~     screening visit and then for further assessments if included (Visit 1). The maximum time~     that a subject may be enrolled in the study is 33 days from the screening visit to follow~     up.~   "
74953|NCT02076256|"~     Helping relationships from significant others may assist patients with chronic kidney~     diseases to exercise health behaviors. Patients will adhere on the suggestions from medical~     staff and perform health lifestyle to maintain healthy behavior. The progress of the disease~     may be delayed.~      The research is a 3-year study to explore the influence of helping relationships on healthy~     behaviors among patients with chronic kidney disease. Building on the findings from the past~     three years study and the literature on trans-theoretical Model, helping relationships will~     be articulated. A helping relation intervention will be applied to evaluate its effect on~     healthy lifestyle and quality of life.~      The first year study will be a survey design. An instrument to measure the helping~     relationship will be established and tested. Total of 200 participants will be recruited to~     test the reliability and validity of the instrument. After evaluating the psychometric~     properties of the instrument, items may be revised according to the results. The second year~     of research will be a cross-section study. Of 250 subjects will be recruited to explore the~     correlations between helping relationships, healthy life styles, and quality of life. Data~     will be analyzed using hierarchical linear regression. In the third year, an experimental~     design will be applied to test the effect of a helping relationship intervention. One~     hundred and twenty subjects will be recruited and randomly assigned to the experimental and~     the control group for 60 subjects in each group. The helping relationships intervention~     program will be implemented on the experimental group. And the control group will be~     provided with routine nursing care. Data will be collected at baseline, the sixth and the~     ninth month of the third year of study. Data will be analyzed using generalized estimating~     equation measures to evaluate the effect of the intervention program.~   "
74954|NCT02076243|"~     This is an investigator initiated phase II study to assess the efficacy of a chemotherapy~     called nab-paclitaxel as first line cytotoxic chemotherapy in subjects with unresectable~     locally advanced or metastatic cutaneous squamous cell carcinoma (SCC). All subjects receive~     the treatment by vein weekly and receive the same dose of the treatment.~      The risk of developing cutaneous SCC is approximately 10% in a lifetime. The vast majority~     are treated surgically and do not recur. However a small percentage become unresectable over~     time or metastasize distantly in the body. Unresectable and metastatic cutaneous SCC has a~     poor prognosis and oncologists often choose a whole body therapy without the benefit of~     prospective efficacy data. Very little prospective investigation into the efficacy of~     specific chemotherapy regimens as a function of line of therapy has been performed in this~     patient population. Nab-paclitaxel is type of chemotherapy that has demonstrated activity in~     other types of cancer such as lung and head and neck cancers. The primary objective of this~     study is to determine the response rate (percentage of subjects with tumor shrinkage) to~     nab-paclitaxel treatment in subjects with cutaneous SCC who have not received cytotoxic~     chemotherapy in the unresectable or the metastatic settings.. Secondary objectives are the~     progression free survival (time until tumor starts to grow), safety, assessment of the~     percentage of subjects whose tumor expresses a protein called SPARC, and correlating the~     expression of SPARC with response to treatment. To determine if the tumor expresses SPARC~     part of a prior standard biopsy such as that performed to establish the diagnosis of SCC~     will be used. SPARC is a protein that is overexpressed in a range of different cancer types~     and may alter the environment around the tumor possibly in a way that may make the SCC more~     responsive to treatment with nab-paclitaxel.~   "
74955|NCT02076230|"~     This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite~     profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent~     treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid~     tumors.~   "
74957|NCT02076204|"~     Adverse birth outcomes result in significant emotional and economic costs for families and~     communities. Research suggests that poor birth outcomes are influenced by a variety of~     social, psychological, behavioral, environmental, and biological factors. Home visiting~     programs represent a promising means of impacting each of these areas.~      The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start)~     will evaluate the effectiveness of two evidence-based home visiting models at improving~     birth outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied~     - Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some~     evidence of improving birth outcomes in prior research.~      The overall goals of the study are to determine whether home visiting programs improve birth~     outcomes and reduce health care costs in the child's first year. In addition, the evaluation~     is designed to investigate the features of local programs and of home visitation that lead~     to greater effects on birth outcomes and health care costs. The study includes an impact~     analysis to measure what difference home visiting programs make on maternal prenatal health~     and health care use, preterm birth and other birth outcomes, and infant health and health~     care use. It also includes an implementation analysis that will describe the families who~     participate and examine how the program models operate in their local and state contexts.~     The primary data used in the study are expected to be from surveys completed by families and~     home visiting staff, Medicaid and CHIP data, vital records, and program service records.~     Among families who are eligible for the study, random assignment will be used to select~     families for enrollment in home visiting services. Those selected for home visiting services~     will form the program group, and those not selected will form a comparison group. The~     research team will monitor both groups over time to see if differences emerge in the outcome~     areas mentioned above. Although the study will affect which families can enroll in home~     visiting services, no fewer families will be served as a result of the study.~   "
74958|NCT02076191|"~     The purpose of this study is to test the safety and tolerability of ruxolitinib at different~     dose levels in combination with decitabine and the effectiveness of ruxolitinib in~     combination with decitabine in patients with accelerated or blast phase Myeloproliferative~     Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are~     produced. Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA)~     for the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak~     proteins that are often abnormal in MPN. A recent clinical study showed that ruxolitinib~     treatment could put some patients with this disease into remission. Decitabine is a~     chemotherapy, approved by the Federal Drug Administration (FDA), that has been used to treat~     acute leukemia. It works in some patients, but most patients with accelerated and blastic~     MPN do not respond to treatment. Ruxolitinib and decitabine will be combined in this study~     to find out what dose of the two medicines are safe together. Using Ruxolitinib in~     combination with Decitabine is experimental. The investigators want to find out what~     effects, good and/or bad it has on the patient and the disease.~   "
74959|NCT02076178|"~     This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate~     the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation~     (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable~     agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week~     intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized~     in a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral~     744 (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study,~     followed by a one week washout period. Following safety lab assessments from the Oral Phase,~     participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744~     LA or placebo at three time points at 12 week intervals. IM injections will consist of 800~     mg of 744 or a matching control~   "
74960|NCT02076165|"~     Women Veterans have high rates of insomnia. Prior research and our preliminary findings show~     that insomnia impacts the health and quality of life of women Veterans and that those with~     insomnia prefer non-medication treatments over sleeping pills. The proposed study will~     compare two non-medication behavioral treatments for insomnia to determine impacts on~     adherence rates and sleep/wake patterns. The results of this study will ultimately improve~     the repertoire of available behavioral treatments for insomnia within VA and improve~     important health and quality of life outcomes among women Veterans who receive VA~     healthcare.~   "
74961|NCT02076152|"~     In this research study, the investigators are using FMISO-PET and MRI scans to explore the~     delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before~     and after treatment.~      Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with~     recurrent glioblastoma . It works by targeting a specific protein called VEGF, which plays a~     role in promoting the growth or spreading of tumor blood vessels. Since anti-VEGF agents~     also affect normal blood vessels in the brain, they can inhibit the way other drugs used in~     combination with bevacizumab are delivered to the tumor.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells. For the PET scans in this~     research study, the investigators are using an investigational radioactive substance called~     FMISO. Investigational means that the role of FMISO-PET scans is still being studied and~     that research doctors are trying to find out more about it. FMISO goes to areas with low~     oxygenation so parts of the tumor that do not have enough oxygen can be seen.~      In addition, a vascular MRI will be used to evaluate the changes in tumor blood flow, blood~     volume, and how receptive blood vessels are. This scan will be performed at the same time of~     the FMISO-PET scan.~   "
74962|NCT02076139|"~     This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers~     with or without tuberculosis infection. This trial aims to study the effect of the probiotic~     Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week~     after the first administration and the global tolerability of the treatment. Nyaditum resae®~     is a preparation in the form of drinkable vials containing heat-killed environmental~     mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on~     immunity, which could reduce the risk of developing active tuberculosis.~   "
74963|NCT02076126|"~     The overall objective is to identify quickly after birth the preterm infants who will~     develop respiratory distress syndrome (RDS) for the purpose of treating them as early as~     possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term~     oxygen treatment.~      We have therefore developed a quick test, which we believe will be ideal for this type of~     diagnostics, and will now test the method in a preclinical trial.~   "
75145|NCT02073747|"~     Empirical data from physician observation indicates an increase in serum lactate in acute~     asthmatic patients being treated with inhaled albuterol therapy.~      It is not clear if this increased serum lactate is in response to a physiological response~     to the asthmatic process or from the albuterol treatment.~      This study is designed to determine if administration of inhaled albuterol increases serum~     lactate in healthy subjects.~   "
75146|NCT02073734|"~     The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will~     benefit patients' perceived quality of recovery after surgery.~   "
74964|NCT02076113|"~     The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal)~     for patients with multi-level cervical spondylotic myelopathy (CSM). There are no~     established guidelines for the management of patients with CSM, which represents the most~     common cause of spinal cord injury and dysfunction in the US and in the world.~      This study aims to test the hypothesis that ventral surgery is associated with superior~     Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to~     dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord~     dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A~     secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion,~     and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance~     post-operatively is a significant predictor of SF-36 PCS outcome.~   "
74965|NCT02076100|"~     This is a 3-part study of ruzasvir (MK-8408) for participants with hepatitis C infection.~     Successive participants will be enrolled as dose levels are evaluated to find the maximum~     safe and well tolerated dose of ruzasvir. Part I will be for participants with hepatitis C~     virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV~     genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts~     II and III may run concurrently. The primary study hypothesis is that a safe and tolerable~     dose of ruzasvir that reduces viral load will be found to support further clinical~     investigation.~   "
74966|NCT02076087|"~     The overall goal of this proposal is to characterize the immune cell profile of subcutaneous~     abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate~     potential associations between different adipose tissue immune cell types and metabolic~     profile.~   "
74967|NCT02076074|"~     This phase I/II clinical trial studies the side effects of delivering radiation therapy in a~     single session instead of multiple treatments over several weeks and to see how well it~     works in treating patients with low-risk stage 0-I breast cancer. Partial-breast~     irradiation, a type of radiation therapy focused only to the part of the breast that has~     cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single~     fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent~     breast cancer from coming back, and improve the appearance of the breast and quality of life~     of patients with breast cancer.~   "
74968|NCT02076061|"~     This is a longitudinal observational study to identify and validate protein biomarkers for~     COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and~     ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different~     phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore,~     linkage between COPD, cardiovascular disease, and lung cancer will be investigated by~     identifying protein biomarkers.~   "
74969|NCT02076048|"~     The purpose of this study is to take images of the brain in order to see if long-chain~     polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and~     function in middle childhood.~   "
74970|NCT02076035|"~     It is still unknown the pathogenesis of low back pain and a lot of hypothesis were discussed~     for a long time. Because non-invasive imaging modalities greatly underestimate the~     prevalence of epidural pathogenesis an endoscopic examination of the epidural space has been~     advocated as both a diagnostic and therapeutic modality. It seems that immune-inflammatory~     factors play a more substantial role in pain status. Myeloscopic investigation have shown~     how morphological pictures of the epidural area in patients with chronic low back pain~     (CLBP) are much more complex and heterogeneous than what can be identified with traditional~     investigation suggesting a biochemical involvement. Endoscopy of the epidural space~     (epiduroscopy) is a minimally invasive technique, used to directly visualize pathological~     features inside of the lumbar spinal canal to locate tissues responsible of eliciting pain~     and the presence of any pathological structures within the vertebral channel, such as~     fibrous adherences, inflammatory processes, severe fibrosis and/or stenoses, in order to~     realize an effective therapeutic approach in a lot of different CLBP status as those due to~     spinal stenoses or failed back surgery syndrome. To deepen the molecular causes of~     interindividual variability of epiduroscopy outcomes in terms of decrease of pain, it is~     useful to analyze the DNA variants encoding IL6 and IL1 cytokines and to relate them with~     gene expression levels and with the cytokine dosage. By this technique, it is possible to~     analyze in the biopsy of the epidural tissue the specific expression of the cytokines: there~     is already evidence that inflammatory factors may be involved in the genesis of LBP. At this~     regards, it would be really important to compare systemic cytokine levels before the~     epiduroscopy with those detected immediately post procedure and after one month, to~     understand if the cytokines could play a key role and be a biomarker of the epiduroscopy~     outcome.~      Concerning DNA polymorphisms, it has been demonstrated, in many disease-state meta-analyses,~     that the IL6 variant rs1800795 affect gene transcription and influences the IL-6 levels.~     Moreover, interleukin 1 (IL-1) is a major factor controlling the inflammatory response. The~     IL-1 gene family includes the IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1Ra) genes~     that mediate immune and inflammatory responses. SNPs in IL-1α, IL-1β and IL1Ra modify bone~     mineral density promoting intervertebral disc disease (IDD). The simultaneous carriage of~     the IL-1bT3954 and the IL-1Ra A1812 alleles significantly enhances the risk of low back pain~     (LBP) occurrence, the number of days with pain, and the number of days with limitations in~     daily activities due to pain.~      A recent study suggested that methylation status of a single CpG site in the IL6 promoter is~     related to IL6 messenger RNA levels and that lower methylation contributes to the risk of~     developing Rheumatoid Arthritis.~      The investigators will try to identify if it there is a correlation with success of the~     epiduroscopy approach in terms of freedom from pain with genic expression and cytokine~     dosage.~      Finally, the investifators will compare the cytokine gene expression and the DNA methylation~     status of IL6 promoter in patients with favorable outcome and in no responders, to study the~     role in gene expression.~      This study is addressed to detect if the genetic variability might be used in near future in~     clinical setting, to predict the success of epiduroscopy.~   "
74971|NCT02076022|"~     We propose a prospective, randomized clinical study to assess the efficacy of minimally~     invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation~     sites.~   "
74972|NCT02076009|"~     The purpose of this study is to compare the effectiveness of daratumumab when combined with~     lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in~     terms of progression-free survival in participants with relapsed or refractory multiple~     myeloma.~   "
74973|NCT02075996|"~     The purpose of this non-interventional study is to collect data on the efficiency and safety~     of pomalidomide in combination with dexamethasone in the routine application~   "
74974|NCT02075983|"~     Our research is part of the global effort to develop a vaccine against HIV. We aim to~     develop a non-invasive, needle-free 'transcutaneous' vaccine. It will be a water-based~     solution which is placed on the surface of the skin of the upper arm, after the hairs have~     been stripped away. The active component of the vaccine - DNA which contains genes derived~     from the virus - will enter through the hair follicles from which the hair has been~     stripped. The DNA will get into cells, which will use the HIV genes to make copies of virus~     proteins. These proteins will stimulate the body's immune system and, we hope, make it able~     to protect against HIV infection. The research is to assess the safety of this approach, and~     how good it is at stimulating the immune system. We will combine the 'transcutaneous'~     vaccine with an 'intramuscular' version which is injected into the muscle of the thigh, and~     compare this combination with: intramuscular plus 'intradermal' (injection into the skin);~     and intramuscular with added 'electroporation' - use of a pulse of electricity to increase~     uptake of DNA vaccines.~      We will invite healthy men and women to take part in this research. Volunteers will first be~     assessed to ensure they are eligible to participate. A total of 30 will be enrolled and each~     will receive three vaccinations over the course of 12 weeks. We will assess the effects of~     the vaccinations by recording any symptoms experienced by the volunteers, and by analysing~     samples of their blood. The research will take place at the St Mary's Hospital campus of~     Imperial College London, UK. The DNA component of the vaccine is an experimental substance,~     so we will monitor very closely the wellbeing of the men and women who participate in the~     research.~   "
74975|NCT02075970|"~     Neonatal anemia is the most commonly encountered hematologic problem among all neonates~     cared for in the neonatal intensive care unit (NICU). This project seeks to better~     understand the pathophysiology and treatment of this challenging and important condition,~     especially as it affects premature, critically ill very low birth weight (VLBW) infants who~     require intensive laboratory blood monitoring leading to the need for multiple red blood~     cell (RBC) transfusions (RBCTX). In the research strategy proposed in Study 1, Aims 1, 2 and~     3, recombinant human erythropoietin (Epoetin Alpha, PROCRIT, provided by Janssen Scientific~     Affairs) will first be administered to 1.0 to 1.5 kg VLBW infants; then comprehensive~     pharmacokinetics (PK) and pharmacodynamics (PD) data will be systematically gathered and~     analyzed to identify clinical and laboratory covariate parameters differentiating the~     infants based on their level of Epoetin Alpha responsiveness. Finally the Epoetin Alpha~     responsiveness predictors thus determined will be applied prospectively in the Aim 4 Study,~     a 2 x 2 design in which VLBW infants will be identified as good or poor Epoetin Alpha~     responders, based on the predictors, and then randomly assigned to receive Epoetin Alpha~     treatment or no treatment. This will test the central hypothesis: RBCTX can be eliminated in~     the majority of good Epoetin Alpha responders by optimal administration of Epoetin Alpha,~     but only marginal reductions in RBCTx will occur in the poor Epoetin Alpha responders. This~     project challenges the prevailing thinking that the efficacy of Epoetin Alpha dosing in~     stimulating erythropoiesis is insufficient to eliminate the need for RBC transfusions in~     VLBW infants. Based on extensive preclinical and clinical PK/PD studies by our PPG team, we~     contend that previous Erythropoietin treatment studies in VLBW infants were not able to~     realize the full potential of Erythropoietin to eliminate RBCTX (in contrast to the very~     successful use of Erythropoietin in adult renal failure patients) because previous VLBW~     studies were conducted 1) without Epoetin Alpha dosing individualized for the complexities~     of neonatal erythropoiesis and PK/PD of Epoetin Alpha and 2) without consistent criteria for~     RBC transfusion, Epoetin Alpha dosing, and patient enrollment. Net Epoetin Alpha~     responsiveness as reflected in Hb level depends on two components: Epoetin Alpha PD and RBC~     lifespan (Fig 15). By determining RBC lifespan, we will explain inter-subject variability of~     Epoetin Alpha responsiveness resulting from one of these components. The fetal lifespan data~     will be examined for its correlation with gestational age. If the correlation is~     statistically significant, gestational age will be included in the final selection of~     covariates for the population PK/PD model to be developed at the end of Infant Study 1. To~     fully understand the correlation of RBC lifespan with gestational age infants ranging from~     22-42 weeks gestational age will be studied. The overall impact of Project 1 will be~     significant and potentially transformative: the development of a personalized,~     mechanism-driven approach built on sound principles will improve understanding of neonatal~     anemia and will be applicable to the care of premature, anemic infants.~      RELEVANCE Project 1 results confirming our hypothesis that PK/PD optimized Epo treatment is~     effective in eliminating RBC transfusions administered to a select sub-group of NICU infants~     will provide fundamental knowledge about neonatal anemia that will reduce the burden of~     illness and disability caused by this condition. In addition, our results will stimulate~     researchers to extend our findings to other sub-groups with neonatal anemia, ie, smaller and~     sicker infants, and will stimulate novel treatments with similar, new biotechnology-produced~     protein drugs.~   "
74976|NCT02075957|"~     Description of new transcriptional profiles associated with risk of relapse and~     identification of specific sites of relapse in non-small cell lung cancer, toxicity and~     resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer~     (NSCLC).~   "
74977|NCT02075944|"~     The present study will investigate the effects of aerobic exercise on cognition and growth~     factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years.~     The included subjects will be randomized to three different groups including one control~     group and two exercise groups. Subjects randomized to the exercise groups will complete 30~     minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high~     (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor~     cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two~     cognitive tests (measures of concentration and sustained attention), a maximal cycling test~     (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting~     blood samples and blood samples immediately following the cycling test. The blood samples~     will be analyzed for growth factors including BDNF and metabolic factors.~   "
74978|NCT02075931|"~     The investigators have learned that knee replacement patients are not more physically active~     after surgery. This is true even though their pain is less compared to before surgery. This~     low level of physical activity is not healthy. It can increase the chances of weight gain,~     which can create other issues. It can also lessen physical function. Some studies have~     looked at physical activity feedback systems to increase how active people are. Studies have~     investigated face to face patient group meetings for this,too. These systems and meetings~     can increase physical activity. The investigators will study the effects of a physical~     activity monitors with group meetings after knee replacement. The investigators hypothesize~     that physical activity levels and physical function will increase. The investigators goal is~     to help knee replacement patients lead healthier lives and maintain or enhance their~     physical function.~   "
74979|NCT02075918|"~     Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis~     Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis~     Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be~     enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and~     stool will be collected to discover and validate factors associated with diagnosis, severity~     of disease and survival.~   "
74980|NCT02075905|"~     Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab~     for analysis of a validated biomarker panel. Subjects will be stratified to either high or~     low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results.~     Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia~     will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine~     care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia~     will receive surveillance endoscopy in 1 year per routine care. All subjects will be~     administered a questionnaire seeking information about hypothetical willingness to be~     randomized to treatment or surveillance.~   "
74981|NCT02075892|"~     Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics,~     aerobic power and time to fatigue in healthy adults.~   "
74982|NCT02075879|"~     The purpose of this study is to examine the effects of a nurse-led case management programme~     on home exercise training for haemodialysis patients. We hypothesised that: a. There is no~     significant difference in physical functioning between participants receiving the nurse-led~     home exercise training programme and those receiving the comparison care. b. There is no~     difference in depression between participants receiving the nurse-led home exercise training~     programme and those receiving the comparison care. c. There is no difference in quality of~     life and health perception between participants receiving the nurse-led home exercise~     training programme and those receiving the comparison care. d. There is no difference in~     physical activity levels between participants receiving the nurse-led home exercise training~     programme and those receiving the comparison care. e. There is no difference in perceived~     benefits and barriers of exercise between participants receiving the nurse-led home exercise~     training programme and those receiving the comparison care.~      The study was a randomized controlled trial conducted in two haemodialysis units of two~     tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study~     group or comparison group. Participants in both groups received the in-center exercise~     training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed~     to perform exercise at home. The in-center training was focused on flexibility and~     strengthening exercise. Patients were encouraged to have cardiovascular exercises at home~     which will improve their cardiovascular conditions and endurance. The list of cardiovascular~     exercise included brisk walking, bicycling, jogging. Participants in the study group were~     instructed to start walking or brisk walking at low duration and gradually progress to a~     maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case~     managers discussed exercise benefits, explored exercise barriers and developed mutual goals~     with patients. The nurse motivated them and checked the exercise behaviors to ensure~     adherence to the recommended exercise regime. The nurse case managers interviewed the study~     group patients weekly for six weeks and biweekly for another six weeks. Participants in the~     comparison group only participated in the in-center exercise training. The comparison group~     patients received usual care from the nurse without the interviews and mutual goals~     developed.~   "
74983|NCT02075866|"~     Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study~     assessing the characteristics and genetic background of consecutive series of autopsy~     verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a~     specific geographical area in northern Finland.~   "
74984|NCT02075853|"~     The Evans calcaneal lengthening is a common surgical correction used for children with~     spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of~     a trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials~     have been used for this procedure, but both types of grafting materials have associated~     limitations. Autologous grafting materials, which are harvested from the iliac crest at the~     time of surgery, are associated with high rates of prolonged donor site pain. There is~     limited bone available from the iliac crest. For this reason autologous bone grafts are not~     commonly used for the Evan's procedure. Cadaver allografting materials are variable in their~     mechanical and geometric properties. Recently, xenografting materials have been developed~     that have consistent mechanical properties and are available in a larger size that is formed~     to fit the individual patient intraoperatively. The purpose of this study is to evaluate the~     long term outcomes of the procedure with the different graft options. Another purpose is to~     compare the difference in surgical correction obtained with the cadaver allograft and the~     xenografting materials. This study will also observe and evaluate a wide range of outcome~     variables that encompass multiple levels of patient care, from clinical observation to~     parent and patient satisfaction, and compare these with the observed changes in the~     radiographic and plantar pressure parameters of the foot. This data will be evaluated pre to~     post surgery and for two years of follow-up time. The aim is to uncover the characteristics~     of collapse observed with the two different grafting materials.~   "
74985|NCT02075840|"~     This randomized, active controlled, multicenter phase III open-label study is designed to~     evaluate the efficacy and safety of alectinib compared with crizotinib treatment in~     participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive)~     advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio~     to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib,~     250 mg orally BID. Participants will receive treatment until disease progression,~     unacceptable toxicity, consent withdrawal or death. The study is expected to last~     approximately 42 months.~   "
75047|NCT02075021|"~     The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane~     weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum~     toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot~     phase II trial. All treatments will be performed until progression. Assessments will be made~     at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.~      The purpose of this research study is to determine how much of the combination of Revlimid~     and Abraxane can be given safely and how well they work together against the cancer.~      Currently, this trial is in the phase 1 stage.~   "
75048|NCT02075008|"~     This study will assess long-term safety of QGE031 during 12 months treatment in asthma~     patients who completed study CQGE031B2201.~   "
75049|NCT02074995|"~     Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15~     weeks~   "
74986|NCT02075827|"~     Previous studies have shown that subjects who play video games are prone to consume larger~     quantities of food than subjects who are simply resting. This is believed to be due to the~     development of a stress response in the video games group, resulting in increased fuel~     metabolism. However, it was shown that the energy intake of the two groups showed no~     correlation with the subjects' appetite/hunger, which was identical in both groups.~      The investigators propose to explore this issue further by comparing the effects of~     different types of video games on metabolism, using a randomized controlled trial. In this~     study, they will compare the stress levels, heart rate, blood pressure, appetite/mood,~     energy consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of~     subjects playing (a) competitive and (b) problem-solving video games. Measurements will be~     taken preceding, during and after the 1 hour intervention. Following the intervention,~     participants will be offered savoury and sweet foods/drinks, which will allow us to assess~     their appetite preferences and caloric intake.~      The investigators first aim is to determine whether there is a significant difference in~     stress levels, eating habits and energy metabolism in the two groups. Our second aim is to~     determine whether there is a difference in glucose distribution to the muscles and brain~     between the two groups.~   "
74987|NCT02075801|"~     -  Assess the effectiveness of sealing localized marginal defects of amalgam restorations~          that were initially scheduled for replacement of restorations.~        -  The hypothesis was that sealed defective margins of the amalgam restorations shows~          similar performance than replacement amalgam restorations.~   "
74988|NCT02075788|"~     The purpose of this study is to investigate how millet incorporation into different baked~     product types influences glycemic response and satiety.~   "
74989|NCT02075775|"~     This project will be a multi-center, prospective longitudinal cohort for all patients~     undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be~     looking for risk factors for recurrent instability, revision surgery, and poor outcomes.~     Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI~     outcome measures, as well as demographic and socioeconomic information. Surgeons will~     complete a form after surgery with information on radiographic findings, physical exam,~     surgical findings, and the repair. The subject questionnaires will be completed over a~     series of timepoints and the subject's information from the subjects' electronic medical~     record will be abstracted for research data at various timepoints as well. Patients will~     wear a sling post-operatively, and follow standardized rehabilitation protocols, including~     physical therapy.~   "
74990|NCT02075762|"~     The objective of this study is to compare the sample size, architectural preservation and~     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in~     comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted~     Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease~     (ILD).~   "
74991|NCT02075749|"~     Abstract:~      Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief,~     correction of nutritional status and improving the performance status. However, lack of~     standardization is the major obstacle for any scientific evaluation of any CAM trial.~     Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition~     of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong~     demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of~     this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive~     films on oral mucositis in terms of pain control and/or ulcer treatment.~      Methods and Materials: the study was a double-blind, randomized prospective trial of two~     types of mucoadhesive films in the management of oral mucositis occurred during head and~     neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale~     (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were~     enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the~     Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive~     films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive~     films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.~   "
74992|NCT02075736|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients~   "
74993|NCT02075723|"~     The purpose of this study is to determine if sleep restriction provokes an increase in risk~     factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity~     to insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic~     challenge (overfeeding) caricaturing the conditions of modern societies everyday life .~   "
74994|NCT02075710|"~     The purpose of this study is to find out how the amount of fat or sugar in a person's diet,~     or the number of meals eaten each day, affect the amount of fat that people's bodies make,~     the types of fats in the bloodstream, and how much fat is stored in the liver. The study is~     funded by the National Institutes of Health.~   "
74995|NCT02075697|"~     The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.~   "
74996|NCT02075684|"~     The purpose of this research study is to create a prospectively maintained, multicenter~     database of patients undergoing renal biopsy for renal masses performed percutaneously~     (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the~     investigators will collect and maintain the data from the biopsy procedure. This will allow~     us to evaluate our experience with this procedure as well as to participate in~     multi-institutional collaborative studies in the future. At University of California Irvine,~     the investigators routinely biopsy patients with renal masses under real-time ultrasound~     control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure~     performed to diagnose renal mass histopathology. The safety and efficacy of this procedure~     has been well documented in the literature. The indications for percutaneous renal biopsy~     have expanded as there has been a substantial increase in the number of renal masses that~     are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in~     parallel. The biopsy procedure is part of your normal standard of care and if not being done~     for this research project.~   "
75050|NCT02074982|"~     This study will assess efficacy of secukinumab, compared to ustekinumab, in patients that~     have plaque-type psoriasis~   "
74997|NCT02075671|"~     Rosacea is a chronic inflammatory disorder that is characterized by severe flushing~     (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical~     therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid~     recurrence is common following the use of systemic antibiotics, resulting in the chronic use~     of these medications to control the disease. Although the exact pathogenesis of rosacea is~     unknown, treatment for this condition has been investigated based on its similarity to acne~     and photodamaged skin. Case reports have shown promising results in rosacea patients treated~     with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which~     observed significant improvement of papules, pustules, erythema, and flushing following 5 -~     aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the~     role of ALA-PDT in the treatment of rosacea has not been reported.~      We have designed a pilot study investigating the efficacy of ALA-PDT in treating~     papulopustular rosacea. The objectives of the study are as follows:~      Primary objective:~        1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules),~          erythema, and telangiectasia of rosacea as assessed by the Investigator's Global~          Assessment (IGA).~        2. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of~          rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment~          (ILIGA).~           Secondary objectives:~        3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical~          Erythema Assessment (CEA) scale.~        4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of~          rosacea as measured by a difference in inflammatory lesion count.~        5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.~   "
74998|NCT02075658|"~     Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors~     are resistant to chemotherapy and radiation. The traditional treatment, where the entire~     kidney and tumor were removed through an abdominal incision, may now have more long term~     problems than the actual cancer. As a result, less invasive techniques have been developed~     such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an~     insufflation system) and the surgery performed with special instruments through small ports,~     known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing~     technological improvement.~      Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the~     system does not account for pressure changes within the abdomen when instruments are~     inserted or removed. The AirSeal® System consisting of an insufflation, filtration, and~     recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free~     trocar (AirSeal® Access Port) has been designed to create and maintain the pressure barrier~     throughout the procedure. The objective of this study is to collect comparative~     physiological, pulmonary compliance and surgical utility data for both the AirSeal® System~     and conventional insufflators and trocars in a controlled population undergoing~     laparoscopic/robotic renal or peri-renal procedures. Subjects enrolled in this study will~     have their procedure performed using either the AirSeal® System or a conventional~     insufflator and trocars. Both systems have been cleared for use by the FDA's 510(k) process~     and are currently employed in clinical practice, including at University of California,~     Irvine Medical Center. We hypothesize that with the use of the AirSeal® System, laparoscopic~     efficiencies and outcomes will be significantly greater than with the conventional~     insufflator and trocars system.~   "
74999|NCT02075645|"~     A multi-centre prospective cohort study, which examines the effect of a team training~     educational intervention for pediatric resuscitation team members. The study uses~     simulation-based training as the primary teaching method to evaluate the effect of team~     training on team performance, as measured by adherence to PALS guidelines. By re-testing~     participants again after 6-12 months, the study will examine long-term retention of these~     skills. Hypothesis: adherence to PALS guidelines is improved following team training of~     pediatric resuscitation team members.~   "
75000|NCT02075632|"~     This is a multi-center, open-label study to evaluate whether participants follow the~     duration of use instructions for short-term use of alclometasone dipropionate in a~     population of participants with itchy skin conditions who would use OTC treatments for~     relief. The study population will be composed of two different cohorts: chronic condition~     sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin~     experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to~     jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.~   "
75001|NCT02075619|"~     This is an open-label, single-centre, randomized, single dose, three-way crossover, six~     sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination~     (FDC) tablet formulations of amlodipine and rosuvastatin relative to innovator samples under~     fasting conditions, in healthy adult subjects. Subjects will be 12 Chinese and 12 Caucasian~     subjects living in Singapore. The randomisation will be stratified by ethnicity to ensure an~     equal number of subjects will be assigned to each dosing sequence. Subjects will receive~     each of the following three treatments administered in a randomized three-way crossover~     design: a reference treatment consisting of a single 10mg amlodipine tablet and 20mg~     rosuvastatin tablet ; a single fixed dose combination tablet consisting of 10mg amlodipine~     and 20mg rosuvastatin (Test Formulation - FDC 1); and another single fixed dose combination~     tablet consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 2). Two~     test formulations have same active pharmaceutical ingredients (amlodipine and rosuvastatin),~     same doses and different inactive ingredients. Each subject will participate in three~     treatment periods. The study consists of a screening phase, three treatment periods and a~     follow-up visit. The three treatment periods will be separated by a washout period of 12-17~     days.~   "
75002|NCT02075606|"~     Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with~     functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are~     secreting hormones and are located in the area in the middle of the digestive system) and~     their presence usually means that the prognosis for the patient is poor. CTCs have also been~     shown to be valuable as predictive markers following treatment and there is increasing~     interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC~     analysis has the benefit of being relatively non- invasive and quick compared with a~     conventional CT scan and is therefore an attractive method of monitoring the tumour~     throughout the treatment period.~      The purpose of this study is to assess the clinical value that enumeration will have in~     predicting the clinical symptomatic response and progression free survival in patients~     receiving Somatuline Autogel for functioning midgut NETs over a one year period.~   "
75003|NCT02075593|"~     In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination~     (FDC) tablet is being made available to women who become pregnant while participating in~     study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the~     unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing~     the risk for maternal disease progression), but also to reduce the risk of maternal-fetal~     transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study~     also offers the first opportunity to investigate the impact of pregnancy on DTG~     pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of~     women that will be enrolled into this study cannot be established a priori, as unintended~     pregnancies cannot be determined in advance. The maximum number of women would include all~     of those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended~     pregnancies in all of these women would not be anticipated.~   "
75004|NCT02075580|"~     Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients~     modify body image and self-representation. Therefore, the purpose of this study is to~     evaluate the efficacy of psychological intervention on patients undergone this surgical~     practice.~   "
75005|NCT02075567|"~     Background: During and after exercise there is a twofold stimulation of glucose transporter~     type 4 in type 1 diabetes mellitus (T1DM) caused by an exogenous insulin injection and~     muscle contraction. In case of no insulin reduction before exercise and/or an additional~     carbohydrate supplement patients with T1DM would become hypoglycemic. There are no specific~     data dependent on individual exercise intensities and strategies of bolus insulin reduction.~     The aim of the present study is to avoid hypoglycemia during and after exercise and to~     calculate a critical time where blood glucose would decrease to 50% of baseline by a pre~     exercise standardized insulin regimen during standardized cycle ergometer exercises~     dependent on different modes, intensities and energy expenditures as well as counter~     regulatory hormones.~      Methods/design: Participants consist of 7 male subjects aged 18 to 35 years with T1DM~     (fasting C-peptide (≤ 0.3 nmol/l), HbA1c ≤ 64 mmol/mol). After a four-weeks basal insulin~     adaptation of ultralong-acting basal insulin (Novo Nordisk) each subject will perform a~     maximal incremental cycle ergometer exercise test with a reduction of short time insulin of~     40% to determine the individual aerobic/anaerobic threshold called first/second lactate turn~     point (LTP1, LTP2). Four constant load and three high intensity intermittent cycle ergometer~     exercise tests (30min) will be performed at 5% Pmax below and above LTP1 and LTP2 (at 5%~     above LTP2 no high intensity intermittent cycle ergometer exercise test) with a reduction of~     short time insulin doses (standardized breakfast-four hours before each test) of 25% at 5%~     Pmax below LTP1 and 50% at 5% Pmax above LTP1 and 75% at 5% Pmax below and above LTP2 with~     one week interception between testing. 24h before testing subjects will be fitted with a~     continuous glucose monitoring system for at least 48h. Primary outcomes include blood~     glucose decrease from baseline during constant load tests, energy expenditure during~     testing, 24h CGMS measurements and hormones catecholamines, cortisol, glucagon and insulin~     growth factor 1. Secondary outcome measurements include heart rate, lactate and respiratory~     gas exchange values.~      Discussion: If the results confirm the hypothesis, this study could be one of the first~     recommendations for T1DM patients, how to adapt bolus insulin dose individually before~     defined exercises without the risk hypoglycemia during and after exercise.~   "
75006|NCT02075554|"~     The primary objective of this study is to evaluate the safety and efficacy of CALIBER~     expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,~     intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained~     from patients in this 2 year follow-up clinical study.~   "
75007|NCT02075541|"~     The purpose of this Phase II study is to assess the safety, reactogenicity and~     immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in~     patients with moderate and severe persistent airflow obstruction.~   "
75008|NCT02075528|"~     Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of~     6-week acute treatment and 52-week maintenance treatment showed positive results in patients~     with schizophrenia and its clinical improvement may start at Day 4. Some second-generation~     antipsychotics have been found that using the first 2 weeks' treatment results to predict~     the fourth or sixth week's treatment response is acceptable.~      The primary aim of this study is to investigate:~        1. . whether the early prediction model used in other atypicals could also be applied in~          paliperidone ER.~        2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER~          treatment in this study~   "
75009|NCT02075515|"~     The purpose of this study is to demonstrate lot-to-lot consistency in terms of~     immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study~     is designed as a randomized, double-blind study with three parallel groups.~   "
75010|NCT02075502|"~     The primary aim of the study is to determine the effect of a community-based walking~     exercise program with detailed training, monitoring, and coaching (TMC) exercise components~     enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary~     outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).~   "
75011|NCT02075489|"~     This study will provide symptomatic veterans with acupressure treatment and determine its~     effectiveness in fatigue relief and pain management for Gulf War Illness (GWI).~     Investigators plan to recruit patients reporting symptoms of GWI through the Department of~     Veterans Affairs (VA), and randomize them into acupressure group (to receive acupressure~     treatment) and control group (to receive Reiki treatment). The acupressure treatment, twice~     per week for 6 weeks, will be offered by a licensed acupressure practitioner. Evaluations~     will be made before and after treatment (at 6 weeks). Clinical outcomes will be compared~     between groups (acupressure group vs. control group) and between different timepoints~     (before treatment vs. after treatment) within the same group.~      The results of this study may provide useful information to develop more effective treatment~     for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown~     excellent promise within its Eastern traditions, if successful, this study has the potential~     to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of~     veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may~     lend to better patient acceptance and ultimately, greater clinical accessibility.~      Hypotheses~        1. Acupressure besides routine clinical care will produce a more complete fatigue relief~          and pain alleviation in veterans with GWI versus routine clinical care plus reiki~          treatment.~        2. EEG measures will exhibit a positive change when fatigue is relieved and pain is~          alleviated for symptomatic veterans after effective treatment.~   "
75012|NCT02075476|"~     The purpose of this study is to evaluate the effectiveness and safety of two surgical~     techniques for the treatments of proximal extremity humeral fractures and fractures luxation~     in three o four fragments of Neer's classification.~   "
75013|NCT02075463|"~     The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb)~     concentration, or maintain it within the target range, and the safety and efficacy of~     GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia~     associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data~     generated will inform dose requirements for any chronic rhEPO hyporesponsive~     hemodialysis-dependent subjects included in future clinical trials. The study consists of a~     4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up~     period.~   "
75051|NCT02074969|"~     The purpose of this study is to assess the differences between two different types of~     devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this~     study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA)~     have a better outcome and lower complication rates than patients treated with the Gamma Nail~     (GN3).~   "
75052|NCT02074956|"~     This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in~     five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative,~     and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the~     target population for which AERAS 404 might be indicated, AERAS 404 will be administered to~     individuals already vaccinated with BCG~   "
75053|NCT02074943|"~     The investigators plan to conduct a clinical trial to assess the effects and safety of~     platelet rich plasma on androgenetic alopecia.~   "
75014|NCT02075450|"~     Our project aims to improve the delivery and assessment of cardiopulmonary resuscitation~     (CPR) during pediatric cardiac arrest by introducing 2 novel approaches: 1. We will evaluate~     the effectiveness of a novel, credit card sized, and highly affordable nano-card CPR~     visual feedback device to improve compliance with HSFC CPR guidelines when used during~     simulated pediatric cardiac arrest; 2. We will also develop and study a novel,~     Just-in-Time (JIT) CPR training video, integrating proven educational methods (video-based~     lecture, expert modeling, practice-while-watching), and use the CPR visual feedback device~     to provide real-time coaching.~      We hypothesize that:~      H1: The use of a CPR visual feedback device will improve compliance with current HSFC CPR~     and resuscitation guidelines during a simulated pediatric in-hospital cardiac arrest~     scenario compared with standard CPR with no visual feedback.~      H2: A JIT CPR Training Video, viewed by healthcare providers 2-4 weeks prior to the~     resuscitation event, will improve compliance with current HSFC CPR and resuscitation~     guidelines during simulated pediatric cardiac arrest compared with those healthcare~     providers with no prior exposure to the JIT CPR Training Video.~      H3: That there is poor correlation between providers' perception of CPR quality and actual~     measured CPR quality H4: That task load varies depending on provider role and type of~     clinical scenario~   "
75015|NCT02075437|"~     This study will provide tools to develop and pilot an intervention for Functional Abdominal~     Pain (FAP) using a ten session intervention with children ages 5-8. Investigators will train~     the subjects to be Feeling and Body Investigators. During treatment phases the following~     will occur 1) gather clues (learn), 2) investigate (experience: perform interoceptive~     mystery missions to explore a body sensation), 3) organize body clues (contextualize: recall~     other contexts that evoke similar sensations), and 4) go on increasingly daring missions~     (challenge: decrease avoidance and safety behaviors). The FBI intervention will be developed~     and refined in 26 child-caregiver dyads during the current R21 phase. In the R33 phase~     investigators will randomize 100 subjects with FAP to FBI or an active control group in~     order to conduct a pilot-test of the feasibility, acceptance, and clinical significance of~     FBI. Young children with FAP who complete the FBI early intervention will learn to~     experience changes in the viscera as fun and fascinating, rather than scary, and will~     develop new capacities for pain management, adaptive functioning, and emotion regulation.~     For the R21 Phase (assessing initial feasibility) investigators hypothesize that ≥ 80% of~     participants enrolled in FBI will complete treatment and that ≥ 80% of participants will~     complete home-based practice assignments.~   "
75016|NCT02075424|"~     The purpose of this study is to describe biological stress (cortisolemia) and perceived~     stress in Emergency Call Center Operators and Doctors while processing a center 15 call.~   "
75017|NCT02075411|"~     Anterior cruciate ligament repair using hamstring autograft in children is a painful~     orthopedic procedure. The current practice to provide analgesia for this procedure include~     femoral continuous perineural infusion and femoral single shot peripheral nerve block, along~     with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be~     associated with adverse side effects, which include, but are not limited to nausea,~     vomiting, constipation, pruritus and respiratory depression, comparing the amount of opioid~     used with either analgesia delivery method is needed.~   "
75018|NCT02075398|"~     To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside~     Respiratory Patient Monitoring System, for performance during motion conditions.~   "
75019|NCT02075385|"~     General Objective: To evaluate the swallowing results of speech pathologist rehabilitation~     of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant~     chemotherapy and radiotherapy concomitant to chemotherapy.~      Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced~     oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which~     had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with~     chemotherapy. Patients are randomized on two groups: control group and speech pathology~     therapy group~   "
75020|NCT02075372|"~     The successful re-opening of a blocked coronary artery has a beneficial effect on the~     further clinical course (e.g. improvement of clinical symptoms, improved quality of life,~     increased heart function, etc.). However, some types of blockages are more difficult to open~     by means of percutaneous coronary intervention (PCI), a procedure which is commonly used for~     these kind of problems. This procedure makes use of a technique in which special wires,~     balloons, stents (metal or polymeric tube-like structures) and devices are utilized to~     re-open or revascularize a blockage in one of the blood vessels of the heart. This type of~     blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede~     the revascularization of the blood vessel.~      Nevertheless, remarkable progress has been achieved over the past few years in the area of~     CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as~     guidewires, guiding catheters, devices, balloons and stents, as well as different techniques~     have been developed. However, at present, reluctance to open CTOs still exists, due to the~     indications and outcomes of percutaneous revascularization as well as the technical~     difficulties which commonly arise during these interventional procedures. The presence of~     these difficulties results in suboptimal success rates worldwide (±70-80%), despite these~     many innovations.~      To increase these success rates and to make sure more interventional cardiologists will~     treat CTOs, a hybrid treatment algorithm has been developed with the materials (e.g.~     CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available.~     The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid~     algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter),~     used in this algorithm. To be able to do this, data concerning the patients' demographics,~     CTO characteristics, procedure and outcome will be collected in the form of a registry. This~     registry will be performed in several European centra (Belgium, the Netherlands, United~     Kingdom, France). Since the study will only collect data and no intervention is performed,~     this will be an observational study. At regular time points, the data will be checked for~     errors or inconsistencies. To do this, site visits will be performed at pre-defined times.~   "
75021|NCT02075359|"~     The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors,~     in a wide range of children using energy expenditure measured by respiration calorimetry.~     Energy expenditure will be predicted from the combination of heart rate and activity~     measured by accelerometry. Prediction equations for energy expenditure will be tested and~     validated against a stable isotope method called doubly labeled water for the measurement of~     free-living total energy expenditure.~   "
75022|NCT02075346|"~     Use of an investigational oximetry system to evaluate the triggering of the sensor off~     status with the marketed off-the-shelf sensors.~   "
75023|NCT02075333|"~     The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose~     (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive~     performance, and blood glucose level.~   "
75147|NCT02073721|"~     The use of electrical stimulation to reduce urinary incontinence in men undergoing~     prostatectomy exercises of the pelvic floor muscles (MAPs)~   "
75024|NCT02075320|"~     Purpose: The proposed research, if successfully implemented, will result in a low-dose,~     low-cost, and highly effective method for screening of lung cancer, leading to reduction of~     the lung cancer mortality rate. Using the s-DCT system the imaging dose for a full~     tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted~     imaging time of 2s is 1/5 to 1/3 of that from a current commercial DCT system at the same~     imaging dose. Beyond lung cancer screening, the low-dose and sensitive 3D lung imaging~     modality will likely to find applications in areas such as monitoring of pediatric cystic~     fibrosis patients where reduction of imaging dose is critical.~      Participants: One hundred (100) patients undergoing a clinical non-contrast CT for their~     lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of~     their clinical CT and chest radiograph, with no intervening procedures or therapies.~      Procedures (methods): The purpose and endpoint of this study is to compare the sensitivity~     of the s-DCT system to the conventional chest radiographs with non-contrast chest CT as the~     reference standard. One hundred (100) patients undergoing a clinical non-contrast CT for~     their lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week)~     of their clinical CT and chest radiograph, with no intervening procedures or therapies.~   "
75025|NCT02075307|"~     Obesity usually brings with it disturbances in the body that increase the chances of~     developing serious diseases like diabetes and cancer. These disturbances include one or more~     symptoms of a condition called metabolic syndrome that often leads to diabetes. High~     levels of damage to the DNA that makes up our chromosomes have also been observed in obese~     people. It is possible that these two disturbances are connected. The goal of this project~     is to test this whether consumption of blueberries will improve these abnormalities.~   "
75026|NCT02075294|"~     It is estimated that 350-400 million people have chronic infection with hepatitis B virus~     (HBV) all over the world. In china, 93 million individuals suffer from this chronic~     condition. Currently, seven medications are approved for the treatment of hepatitis B: two~     formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one~     of the longer average life spans, and the size of the aged population has been increasing~     rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the~     potential for development of cirrhosis or hepatocellular carcinoma in such patients is real.~     Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has~     become first choice due to the more side effect of INF and the resistant of LAM and LdT. But~     treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will~     evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older~     patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV~     therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in~     the emergence rate of side effect.~   "
75027|NCT02075281|"~     The purpose of this study is to determine the optimal dose and regimen of HM11260C, in~     combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise~     considered in stable health.~   "
75028|NCT02075268|"~     An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of~     Prasugrel 30 mg or 60 mg in healthy male adult subjects~   "
75029|NCT02075255|"~     The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance~     OCS in systemic corticosteroid dependent patients with severe refractory asthma with~     elevated eosinophils.~   "
75030|NCT02075242|"~     Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With~     Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with~     Hepatitis B Virus(HBsAg) Positive~   "
75031|NCT02075229|"~     Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently~     available multichannel cochlear implant systems for newly implanted adults with an~     indication based on open-set sentence recognition that expand criteria currently used by~     Center for Medicare & Medicaid Services (CMS), and 2) to assess the correlation between~     measures of speech recognition in candidates for cochlear implants and their utility in~     predicting audiologic and quality of life outcomes after implantation.~      Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical~     insurance coverage.~      Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in~     a patient population that does not meet current CMS candidacy criteria.~   "
75032|NCT02075216|"~     Muscle precursor cells constantly regenerate striated muscles, and include the quiescent~     satellite cells located beneath the basal lamina of skeletal myofibers, which are~     responsible for repair of the terminally differentiated striated muscle tissue.~     Transurethral implantation of autologous myoblasts may represent an improved alternative to~     synthetic bulking agents, with the unique ability to compensate for the deficient muscle~     fibers in the urethral sphincter. Clinical studies of cell therapy based treatment of~     sphincter insufficiency, using muscle derived stem cell transplantation was carried out in~     patients with stress incontinence revealed and confirmed the ability of cell therapy to~     improve the structure and contractile function of the sphincter. In this study autologous~     heterotopic myoblasts will be transurethrally injected in patients with bladder extrophy~     epispadias complex who remained incontinent after staged bladder reconstruction and bladder~     neck reconstruction.~      The aim of this study is to investigate the potential therapeutic effects of autologous~     myoblast injection for the treatment of children presenting with urinary incontinence after~     modern staged repair and bladder neck reconstruction of extrophy-epispadias complex as well~     as studying the safety, efficacy and durability of the procedure, and health related quality~     of life.~   "
75033|NCT02075203|"~     Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety,~     Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and~     BCG Revaccination in Healthy Adolescents~   "
75034|NCT02075190|"~     The objective is to examine the efficacy of computerized interventions for increasing~     well-being and cognitive functioning. The study will seek to validate emerging online~     delivery methods of psychiatric assessment and treatment. This will allow us to test the~     efficacy of this intervention in a larger and more geographically broad sample than is~     possible through traditional recruitment and treatment, and to do so in a highly~     cost-effective manner.~   "
75179|NCT02073305|"~     The purpose of this study is to prospectively evaluate the impact of sleep apnea on the~     cardiovascular morbidity and mortality of patients with end-stage renal disease.~   "
75035|NCT02075177|"~     Currently there is no known effective treatment for recurrent/resistant neuroblastoma.~      Fenretinide is an anticancer agent that may work differently than standard chemotherapy~     medicines. It may cause the buildup of wax-like substances in neuroblastoma cancer cells,~     called ceramides or other chemicals, called 'reactive oxygen species'. In laboratory~     studies it was found that if too much ceramide or reactive oxygen species build up in~     neuroblastoma cells, they may die.~      In addition, researchers are testing to see if a drug called ketoconazole, commonly used to~     treat fungus infections, can increase fenretinide levels in the body by interfering with the~     body's ability to break down fenretinide.~      This study is being done: 1) to allow patients with recurrent/refractory neuroblastoma~     patients who would otherwise not be able to access fenretinide/LXS oral powder for treatment~     to do so; 2) to further describe the side effects of fenretinide and ketoconazole when given~     by mouth for seven days every three weeks; 3) to determine if a patient's tumor gets smaller~     after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder~     alone.~   "
75036|NCT02075164|"~     Non-alcoholic fatty liver disease (NAFLD) comprises a spectrum ranging from simple fatty~     liver over steatohepatitis (NASH) to liver cirrhosis and cancer (HCC) and is a major and~     increasing health problem affecting nearly 40% of the general population. Moreover, NAFLD is~     an important risk factor for progression of diabetes and atherosclerosis. However, the~     pathomechanisms determining disease progression are poorly understood. The overall aim of~     this project is to test the central hypothesis that excessive fructose consumption provides~     a multiple metabolic hit in the pathogenesis and progression of NAFLD/NASH by impairment of~     hepatic lipid homeostasis and mitochondrial function resulting in hepatic lipotoxicity with~     inflammasome activation and disturbed interorgan cross-talk among insulin sensitive tissues.~   "
75037|NCT02075151|"~     According to World Health Organization (WHO) estimates, more than 200 million people suffer~     from asthma worldwide and in 2009, the disease had claimed 250,000 lives globally. Autopsy~     reports suggest 2 phenotypes of severe asthma: one that is characterized by intense airway~     inflammation with mucus plugging, and the other by severe bronchoconstriction causing~     respiratory failure in the absence of significant airway inflammation. However, it is not~     easy to stratify patients according to phenotypes without bronchoscopy. Although severe~     asthma comprises only 10% of affected individuals, it accounts for more than half of the~     total healthcare spending on asthma. Inhaled corticosteroids are effective by suppressing~     production of multiple pro-inflammatory mediators, unfortunately efficacy plateaus. Addition~     of long acting beta agonist and anti-cholinergic agent to inhaled corticosteroids offers~     some measure of relief but effective treatment of severe asthma remains an unmet goal,~     resulting in intensive utilization of healthcare resources. In 2010, the United States Food~     and Drug Administration (FDA) approved bronchial thermoplasty (BT) as an adjunctive therapy~     for severe asthma. BT is radiofrequency ablation of airway smooth muscle via bronchoscopy~     with each patient undergoing three procedures which targets different lobes of the lung 3~     weeks apart. Studies have demonstrated improved symptom control allowing discontinuation of~     oral steroids in some patients as well as reductions in exacerbations, hospitalizations and~     use of rescue medications. No development of airway strictures or bronchiectasis, and~     regeneration of normal epithelium after BT has been observed. At present, it remains unclear~     if BT benefits all asthma phenotypes or if BT has any effect on airway inflammation and~     remodeling.~      The hypothesis of this study is that bronchial thermoplasty is likely to benefit all severe~     asthma phenotypes, and achieves this by exerting an effect on airway inflammation and~     remodelling.~      The specific aims of the study are: 1) to better define the asthma phenotype who will~     benefit from BT by microarray and gene expression profiling; 2) to study effects of BT on~     airway inflammation; 3) to define its role in the overall asthma management algorithm~   "
75038|NCT02075138|"~     Grass pollen allergens are universally recognised as a major cause of allergic diseases in~     humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.~      The purpose of the current study is to evaluate allergy symptoms and allergy medication in~     subjects with grass-related rhinoconjunctivitis.~   "
75039|NCT02075125|"~     To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment~     elevation myocardial infarction undergoing primary percutaneous coronary intervention.~   "
75040|NCT02075112|"~     The purpose of this study is to determine if soy supplementation during chemotherapy and~     radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is~     a side effect of the standard treatment, and we are testing whether soy supplementation~     during treatment may reduce this symptom and other side effects of chemoradiation.~   "
75041|NCT02075099|"~     Blood donation is a generous act carried out by healthy male and female volunteer donors.~     The safety of blood donation in France is based on rigorous well documented biological and~     medical criteria, in particular concerning the volume of blood to be taken. While whole~     blood donation is very safe, some donors experience faintness during or after donation. Any~     injury resulting from a fall increases its seriousness, especially when it happens outside~     the donation site.~      According to various studies, adverse reactions are experienced by between 0.28% and 2.72%~     of all donors and occur in all categories (sex and age).~      A retrospective evaluation of the frequency of faintness incidents on during whole blood~     donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05%~     in mobile donation units in towns to 4.24% in donation units in high schools, with no~     reporting of delayed incidents of faintness by this donor population.~   "
75042|NCT02075086|"~     A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev)~     maintain the same sensitivity after progression to maintenance treatment because they remain~     dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic~     switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev~     chemotherapy combinations .~   "
75043|NCT02075073|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and~     immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in~     healthy male subjects.~   "
75044|NCT02075060|"~     The aim of this pilot study is to assess the efficacy and toxicity of immediate~     pre-operative instillation of mitomycin C compared to the standard early post-operative .~   "
75045|NCT02075047|"~     The purpose of this study is to determine if ziprasidone is safe and effective for the~     treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).~   "
75046|NCT02075034|"~     This study will compare the dosing regimen of oral rigosertib, which has been used in other~     studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to~     determine if one of the new regimens gives improved results as measured by disease status,~     side effects, and analyses of blood and urine samples.~   "
76222|NCT02059629|"~     The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna~     pacemaker family and the Sentus BP (bipolar) left ventricular lead.~      Furthermore the new wandless RF telemetry function SafeSync and the handling of the Sentus~     lead during implantation will be assessed.~   "
75054|NCT02074930|"~     It is an open-label physiological investigation of the allergic skin reactivity to~     epicutaneous allergen exposition in 20 allergic patients in two different skin conditions.~     The focus of the study is on the skin preparation/condition and not on the specific allergen~     or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy~     was chosen as the basis for the testing. In order to evaluate the effects of the two~     different skin preparation techniques an intraindividual comparison of the skin reactivity~     in terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was~     chosen. The serial dilution approach allows a dose dependent effect evaluation and~     comparison of the sensitivity. The differences will be explained mainly by the two different~     skin preparations allowing a quantitative comparison of these techniques.~   "
75055|NCT02074917|"~     This is a prospective, randomized and double-blind clinical trial about anatomical~     single-bundle anterior cruciate ligament (ACL) reconstruction.~      One of the most common causes of ACL reconstruction failure is poor graft positioning. There~     is evidence that graft placement aligned with native insertion sites results in superior~     clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of~     the native anatomy to restore physiological knee kinematics more accurately.~      This study aims to investigate clinical outcomes and dynamic knee stability with force~     platform and other functional tests after ACL reconstruction in two different groups of~     tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.~      It was hypothesized that there would be clinical or dynamic stability differences between AM~     or Central tunnel groups in ACL reconstruction.~   "
75056|NCT02074904|"~     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI) to~     examine the effects of topiramate on brain and behavioral responses in heavy drinkers to~     appetitive alcohol reminders (cues that motivate continued alcohol use and relapse). This~     project will yield novel findings on brain and behavioral responses to alcohol cues, the~     effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's~     ability to blunt alcohol cue reactivity and heavy drinking.~   "
75057|NCT02074891|"~     A health services implementation pilot study, conducted with an observational cohort of~     HIV-uninfected persons including men who have sex with men, heterosexual women and men, and~     injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at~     four federally qualified health centers that provide sexual health and primary care services~     to communities with high HIV incidence/prevalence.~   "
75058|NCT02074878|"~     Crizotinib is a medication that is taken by mouth. It has shown that it can help slow down~     or stop the growth of tumor cells. The marketing name of the drug is Xalkori. It has been~     approved by the FDA (Food and Drug Administration) to treat other types of metastatic~     cancer, but the investigators believe it may be helpful to treat breast cancer as well.~      Sunitinib is the other medication used in the study. It is also taken by mouth in the form~     of a capsule. The marketing name of this drug is Sutent. It too has been approved by the~     FDA to treat other types of cancer, but not for breast cancer.~      In this study the investigators will be combining both of these two treatments, but at~     different doses.~      One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg~     once a day.~      One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg~     once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with~     Sunitinib 37.5 mg once a day.~   "
75059|NCT02074865|"~     The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal~     and childhood bacterial infections in low-income countries,in particular those caused by~     antibiotic resistant bacteria. This program will address both healthcare associated, as well~     as community acquired infections. Beside its main challenge, the ChARLI program will also~     allow the assessment of the economic burden of these infections, the improvement of their~     medical care and then ultimately help to set public health interventions and guide public~     health measures necessary to combat bacterial infections and bacterial resistance in~     children. It will also lead to set up more basic research investigation to better understand~     how pathogenic and epidemic may be the resistant clones in these countries and to experiment~     innovative strategies devoted to prevent these infections.~      In order to achieve these objectives, an international paediatric cohort will be created,~     and monitored a platform. This will be done first within the Institut Pasteur International~     Network (IPIN) and possibly extended in some others low income countries where the IPIN has~     no center. This constituted initiative will represent the first international pediatric~     program of its size to be located in low-income countries and specifically focusing severe~     bacterial infections and bacterial resistance to antibiotics~   "
75060|NCT02074852|"~     The objective this trial is to compare immediate and 12 hours postoperative removal of~     urinary catheter after elective cesarean section; and whether early removal is associated~     with lower risk of urinary infection compared with delayed catheter removal.~   "
75061|NCT02074839|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that~     harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where~     cohorts of patients will receive ascending oral doses of AG-120 to determine maximum~     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study~     is a dose expansion phase where four cohorts of patients will receive AG-120 to further~     evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose.~     Anticipated time on study treatment is until disease progression or unacceptable toxicity~     occurs.~   "
75083|NCT02074553|"~     This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period~     cross-over study will compare the bioequivalence of three test alectinib capsule~     formulations with the reference capsule formulation in healthy adult participants. All~     participants in both fasted (Part 1) and fed (Part 2) conditions of the study will receive~     each of 4 treatments: Treatment A (alectinib with 50 percent [%] sodium lauryl sulfate [SLS]~     [reference]), Treatment B (alectinib with 25% SLS [test]), Treatment C (alectinib with 12.5%~     SLS [test]), and Treatment D (alectinib with 3% SLS [test]) in a randomized sequence. Each~     treatment will be given as a single 600 milligrams (mg) oral administration in an upright~     position on Day 1 in a fed or fasted condition, followed by a 10-day washout period.~   "
75084|NCT02074540|"~     To determine the predicting factors and indicators of compliance with insulin treatment in~     Diabetes Type II patients.~   "
75062|NCT02074826|"~     This prospective, single-centre cohort study aims to investigate the association between~     known genetic Atrial Fibrillation (AF) risk variants and the amount of left atrial fibrosis~     found in patients undergoing clinically indicated AF catheter ablation procedures.~      Left atrial fibrosis is increasingly recognized as a fundamental part of the~     pathomorphological substrate creating an electrophysiological environment needed for~     electrical conduction heterogeneities. Such identification and treatment of left atrial~     fibrosis has already entered routine clinical use for RF catheter ablation in an attempt to~     develop an individualized and tailored treatment strategy. Today, it is unclear what impacts~     the development, the extent and the localization of left atrial fibrosis in different~     patients.~      A number of genetic risk variants have been described that confer risk of AF and have been~     widely replicated. This indicates that genetic variants contribute to the risk of the~     individual to develop AF throughout his life. However, the mechanisms of how genetic variant~     impact the development of clinical arrhythmias is not yet well understood.~      We hypothesize that genetic influences that lead to tissue changes may play a role in the~     development of the arrhythmia substrate for AF. This is likely to be especially true for~     those with a relatively brief history of AF and modest clinical disease burden. Therefore,~     we plan to investigate the association between known genetic AF variants and a detailed~     disease phenotype obtained from individual left atrial voltage mapping.~   "
75063|NCT02074813|"~     Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows~     a significant improvement of dyspnea in subjects with severe or very severe COPD than a~     conventional pulmonary rehabilitation program alone.~   "
75064|NCT02074800|"~     The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose~     levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose~     of Part 2 of this study is to access the pharmacokinetics (what the body does to the study~     medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived~     CNTO 328.~   "
75065|NCT02074787|"~     Burn injuries are a common presentation to A&E in the UK (175,000 per year) of whom 13,000~     require hospital admission. Treatment of a single burn can cost more than £63,000, and is~     ultimately dependent on the depth. Most burns are assessed by experienced clinicians within~     a few days of injury. Accurate evaluation of burn depth can be very difficult with the naked~     eye. Inaccuracy can lead to longer hospital stays, worse scarring and greater financial~     costs for the NHS. Where the burn depth (and the degree of damage to the underlying blood~     supply of the skin) is not clear by visual inspection, adjuncts may be used to aid clinical~     decision-making. Currently, the gold standard method of assessing skin blood flow in order~     to help burn specialists in their assessment of burn depth is Laser Doppler Imaging (LDI).~     However, LDI machines can be very large, slow to collect the images, and a single imaging~     unit costs roughly £50,000. Consequently their use is restricted to the assessment of small~     burns in compliant patients treated in specialist units. Thermal imaging (thermography) has~     evolved rapidly as a useful diagnostic tool in many medical disciplines. Previous studies~     have shown that there are significant changes in skin physiology (such as temperature and~     pigmentation) depending on the depth of the burn. Portable, high-resolution thermal cameras~     are now affordable, easy to use and can provide numerical results in under a second.~     Similarly, measurement of skin pigment levels can be achieved using portable devices such as~     the Spectrophotometric Intracutaneous analysis scope (SIAscope). The aim of this study is to~     determine if alternative measures such as thermography or SIAscope can be as useful in the~     assessment of adult burns as LDI currently is. If this study demonstrates this then these~     results will inform further studies that would investigate these alternative imaging methods~     as a diagnostic and prognostic tool in the management of burns not only in adults but also~     in children presenting to non-specialised units such as A&E.~   "
75066|NCT02074774|"~     The overall objective of this study is to demonstrate that the IntellO2 device providing~     automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously~     breathing infants with fluctuating arterial blood oxygen saturation levels is safe and~     efficacious in the routine clinical environment. Specifically, it is hypothesized that the~     IntellO2 will perform as well or better than standard practice for maintaining infants'~     arterial blood oxygen saturation in a target range while minimizing the exposure to elevated~     levels of oxygen in the inspired gas.~   "
75067|NCT02074761|"~     Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to~     evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.~   "
75068|NCT02074748|"~     This study is an observational change from baseline outcome measures design. Data is~     collected for the sake of evaluating treatment (fusion surgery) performed as standard~     medical care, but the investigator does not assign specific interventions to any~     participants in this study.~   "
75069|NCT02074735|"~     The purpose of this study is to determine if citicoline, as an add-on therapy, will help~     reduce alcohol use in outpatients with alcohol dependence.~   "
75070|NCT02074722|"~     Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,~     has become increasingly prevalent due to an increase in awareness of the potential health~     benefits, and improvements in concentration that this training can provide to practitioners.~     In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the~     initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).~      The PI's hypothesis is that MBAT will improve performance in SMR based BCI.~   "
75071|NCT02074709|"~     In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after~     ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound~     infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.~   "
75072|NCT02074696|"~     The purpose of the study is to assess the status of brain-derived neurotrophic factor brain~     (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will~     investigate the relationship of the status of BDNF with cortical excitability changes and~     learning that occur during a motor training paradigm. We aim to 1) determine cortical~     excitability changes by using transcranial magnetic stimulation (TMS) before and after~     training; 2) to determine finger tracking accuracy before and after training; and 3)~     determine the presence of BDNF polymorphism in each participant.~      We are testing healthy adults in this study, and eventually would like to apply to persons~     who have neurologic disorders such as stroke or dystonia. By applying a magnetic field to~     the outside of the head, electrical currents are produced within the brain that can~     stimulate brain tissue. Using TMS, the brain can be studied to gain a greater understanding~     of the mechanisms associated with cortical excitability in healthy and patient populations.~     There is limited knowledge of what influence genetic biomarkers such as BDNF have on~     cortical excitability changes within the cortex following learning. Studies have indicated~     that people without this certain gene are less likely to show changes in brain excitability~     during TMS and during motor learning than people with this gene~   "
75073|NCT02074683|"~     The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics,~     steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead~     to osseous prominences in the forefoot that may be seen with painful skin lesions. Disease~     states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy,~     regardless of the etiology, may result in significant pain, epidermal lesions, or~     metatarsalgia. In sensate patients, the pain can lead to emotional and physical pain,~     leading to productivity and financial losses.~      It is well documented that plantar pressure is directly correlated with plantar tissue~     thickness, with the loss of plantar fat being a fundamental mechanism for pressure related~     foot disorders.Autologous fat grafting to areas of plantar fat pad atrophy may reduce~     plantar pressures, and thus serve as a treatment for metatarsalgia, corn and callus~     prevention, and possibly ulcer prevention in diabetics. Plastic surgeons, with significant~     skills in fat grafting, can make a significant contribution.~      Current treatment modalities for fat pad atrophy include silicone injections, fat~     injections, and other temporary fillers; however, no objective studies using autologous fat~     have been performed. Approximately 30 adults who experience pain from fat pad atrophy, will~     have the option to participate. Through a randomized, controlled, cross-over study, some~     patients will receive autologous fat grafting, while some will receive standard of care~     podiatric treatment, then cross-over to fat grafting treatment after a year. Through~     pedobarograph and ultrasound assessments, the focal pedal pressure and tissue thickness~     following treatment will be documented over two years.~      We hypothesize that fat grafting for areas of increased pedal pressure in well-controlled~     diabetics will help decrease foot pressure during gait and increase soft tissue thickness on~     the foot pad, ultimately reducing pain. We also hope to demonstrate that by using autologous~     fat with evidence-based fat transfer techniques, results may be durable. This pilot study~     will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and~     Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.~   "
75074|NCT02074670|"~     The purpose of this study was to evaluate the potential reorganization in the sensorimotor~     cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training~     (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized~     that training with weight bearing associated with conventional motor rehabilitation will be~     able to reorganize the brain.~   "
75075|NCT02074657|"~     To determine safety profile of immunotherapy with natural killer cells and activated~     expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with~     relapsed or refractary acute leukemia~   "
75076|NCT02074644|"~     The purpose of this study is to determine whether prostatic arterial embolization (PAE)~     compared is an effective and safe treatment for benign prostatic hyperplasia in patients~     with severe lower urinary tract symptoms not adequately controlled by medical therapy with~     alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6~     months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and~     evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered~     the possibility of performing PAE after 6 months. All patients may participate on an~     optional 6-months extension study.~   "
75077|NCT02074631|"~     This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects~     treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone~     following hematopoetic cell transplantation (HCT). The purpose of this study is to test the~     hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher~     lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1~     year post-HCT than subjects receiving calcium and vitamin D alone (Control Group). Sixty~     subjects (≥1 and <18 years of age at the time of enrollment and receiving an allogeneic HCT~     for a hematologic malignancy or severe aplastic anemia) will be evaluated at the University~     of Minnesota Amplatz Children's Hospital and Seattle Children's Hospital. Subjects~     randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270~     days after HCT. Laboratory evaluations, DXA, and peripheral quantitative computed tomography~     (pQCT) will be performed at specified time points to evaluate safety and treatment efficacy.~     Subjects will participate in the study for 1 year.~   "
75078|NCT02074618|"~     The purpose of this study was to evaluate the effects of physiotherapy based on the practice~     of supervised exercise on functional capacity and life quality of patients with chronic~     kidney disease.~   "
75079|NCT02074605|"~     Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed~     with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some~     adverse cognitive effects on patients, but there are limited data. The investigators~     hypothesis is that compared to patients with melanoma who do not receive interferon,~     patients who have melanoma and are treated with interferon will show an objective decrease~     in performance on neurocognitive assessment.~      This study will enroll patients with melanoma who qualify for interferon, and either decide~     to undergo interferon treatment or choose watchful waiting instead. All patients will be~     assessed with a cognitive testing battery twice. Observation patients will undergo testing~     at their first appointment in which they consent to the study, as well as at their next~     physician visit, approximately 3 months from the first visit. Interferon patients will be~     tested immediately prior to starting interferon, as well as immediately after completing~     high dose interferon.~   "
75080|NCT02074592|"~     To improve the quality of fetal ultrasound images, self assessment is less resource~     consuming than assessment by an expert reviewer, and may be as effective.~      To test this hypothesis, we randomize volunteer experienced ultrasonographers into two~     groups.~      One group assess their own images (self assessment). The other group has their images~     assessed by an expert. Images are audited via the internet in a standardized procedure that~     generates feedback with recommendation for change.~      Three to 6 months later, participants are audited again. If the improvement in image quality~     turns to be the same in both groups, it will be likely that self assessment is indeed as~     effective as assessment by an expert reviewer - at least for professionals experienced in~     fetal ultrasound.~   "
75081|NCT02074579|"~     The aim of this study is to assess the effect of orally administered TU-100 (5 g three times~     daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.~   "
75082|NCT02074566|"~     Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial~     fibrillation. However, with the rapid evolution in cryoablation technique and its increased~     effectiveness, the risk of complications increases. Therefore it is of utmost importance to~     define the optimal duration of cryoballoon ablation time.The objective of the study is to~     assess the optimal ablation duration using the second generation cryoballoon for isolation~     of pulmonary veins in the treatment of atrial fibrillation.~   "
75085|NCT02074527|"~     Design: Observational - Cross study with followed up for 30 days. The Primary Objective is~     to realize a record that reflects a national overview of the role of cardiac catheterization~     in patients with congenital heart disease in hospitals distributed by geographic density of~     each region of Brazil.~   "
75087|NCT02074501|"~     Background: More than 42% of older people (aged +65) have a stroke and most of them require~     some type of help to self-care at home. Informal caregivers have reported different types of~     need and have shown dissatisfaction with technical and emotional support delivered by~     community health teams. Furthermore, empowering informal caregivers who care after older~     stroke survivors is an important challenge, preventing them from negative outcomes such as~     burden, anxiety and depression or loss of physical function or hospitalization in older~     people.~      Objectives: This pilot study aims to implement and evaluate the impact of an intervention~     based on training and telephone support delivered to informal caregivers who care after~     older people post-stroke.~      Setting: Community health units in Northern Portugal region. Design/Methods: This single~     blinded randomized trial will be delivered by a community nursing team to informal~     caregivers 1 week, 1 and 3 months after a hospital discharge.~      Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary~     outcomes will include burden and health quality of life in caregivers; functionality,~     hospital readmission and institutionalization of older people stroke survivors, measured 1~     and 3 months after intervention.~      Results/Conclusion: Data collection started in February and will be concluded in August~     2014. First results will be published at the beginning of 2015. The InCARE programme will be~     the first pilot in informal caregivers study ever conducted in Portugal. It will highlight~     new ways to support caregivers who take care of older people after a stroke. If successful,~     this study will be translational and it will also allow to disseminate the results in~     Portugal and abroad and implement it as best practice.~   "
75088|NCT02074488|"~     Falls are a significant issue for older adults with vision impairment. Medical conditions~     such as glaucoma and age-related macular degeneration that result in vision impairment~     negatively impact balance. Falling is 1.7 times more likely among older adults with vision~     impairment. In 2010 there were 9,146,026 older adults treated in emergency rooms for~     unintentional falls and injuries from falls are expected to cost the nation an estimated~     $54.9 billion dollars by 2020. Falls can lead to death, depression, and loss of~     independence. However, impaired balance is a modifiable risk factor for falls. A practical~     yet innovative falls prevention program has been developed that is designed to enhance~     balance and proprioception among older adults. This program, UExCEL (UNE-Exercise and~     Conditioning for Easier Living) Balancing Act, consists of simple exercises that can be done~     at home (15 minutes duration-3 times a week) during normal daily activities, requires only~     one brief training session, and no equipment. This study aims to establish an evidence base~     documenting the positive impact of Balancing Act exercises on balance and falls prevention~     for older adults with vision impairment. A randomized controlled trial of older adults with~     vision impairment (best corrected vision of 20/70 or worse) will be conducted over a 6-month~     period (control group n = 35 and Balancing Act intervention group n = 35) to determine the~     impact of Balancing Act on falls, fear of falling, pain, and activity levels. Factors that~     can be expected to affect its adoption and sustained use such as cost in the community and~     social support networks in the home will also be investigated. It is hypothesized that the~     Balancing Act intervention will decrease the number of falls experienced by older adults who~     have vision impairment by improving their gait and balance, reducing their fear of falling,~     increasing their physical activity, and reducing their pain.~      The specific aims of the research are to: 1) Evaluate the impact of Balancing Act on~     standing balance control and proprioception for older adults who have vision impairment,~     using the Tinetti Gait & Balance Test, a validated tool for evaluating gait and balance and~     predicting fall risk; 2) Evaluate the impact of Balancing Act for older adults with vision~     impairment on falls, fear of falling, physical activity, and pain; and 3) Improve adherence~     to the Balancing Act exercise program by facilitating social networks. Data will be analyzed~     through: 1) a descriptive assessment of the baseline demographic characteristics of sample~     members, covariates, and outcome variables, as well as 2) a repeated measures design~     examining the impact of the intervention on study participants.~   "
75089|NCT02074475|"~     Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth~     Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which~     is based on the sum of the normalized pulse beat interval (PBI) and the~     photoplethysmography. SPI indicates the balance between intensity of surgical stimulation~     and the level of anti-nociception (opioid analgesia and neural blockade). This study is a~     Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most~     appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients~     are treated without monitoring adequacy of anaesthesia thus the values are collected blinded~     and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study~     population will be 150 patients.~   "
75090|NCT02074462|"~     Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between~     the efficacy and safety of voriconazole and voriconazole trough concentrations. There are~     several factors that could influence voriconazole concentrations. Inflammation could be one~     of these factors. In a retrospective study was observed that reduced metabolism of~     voriconazole was related to inflammation in patients with severe infections. Reduced~     metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite~     (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an~     algorithm to guide dosing of voriconazole during severe inflammation and to develop a~     multiple linear regression model to describe the contribution of CRP concentrations to the~     variability in voriconazole levels and metabolic ratio.~   "
75091|NCT02074449|"~     Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the~     RV (right ventricle) is weak. The purpose of this study is to get a better understanding of~     the factors that determine RV adaptation and how the RV compensates on therapy. The~     investigator is also interested in how Remodulin (treprostinil) infused over a short period~     (approximately 48-72 hours) affects the patient's quality of life, medical care, and~     personal health behaviors.~      Treprostinil, also known as Remodulin, has been approved by the US Food and Drug~     Administration for use in the treatment of PAH. The investigator has been treating patients~     with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would~     like to establish this practice as safe and effective for the benefit of other centers that~     treat PAH.~   "
75092|NCT02074436|"~     STUDY BACKGROUND AND PURPOSE:~      Patients with hematological malignancies (blood-related cancers) often develop~     thrombocytopenia (low platelet count), which can be made worse by cancer treatment.~      Preventive (prophylactic) platelet transfusion remains the standard of care for~     thrombocytopenic patients. However, bleeding remains a significant problem in these~     patients, affecting approximately 20% of patients with acute myeloid leukemia and 34-58% of~     hematopoietic stem cell transplant recipients. Platelet transfusion refractoriness, the~     repeated failure to obtain satisfactory response to platelet transfusions, is a common~     problem. Alternatives to platelet transfusions are desperately needed for these patients.~      Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis that is an essential~     step in the bleeding process. EACA is approved by the FDA for the treatment of severe~     bleeding-related diseases and complications. A small study has shown EACA to be well~     tolerated and associated with low risk of bleeding in patients with hematological~     malignancies.~      This study will compare EACA versus standard prophylactic platelet transfusion for the~     prevention of bleeding in thrombocytopenic patients with hematological malignancies.~      STUDY DESCRIPTION:~      This is Phase II study to compare EACA versus standard prophylactic platelet transfusion to~     prevent bleeding in thrombocytopenic patients with hematological malignancies. Patients who~     are eligible to take part must give their written agreement before they can be enrolled.~      The study will enroll 100 patients who will be assigned randomly to take EACA twice daily or~     to undergo standard prophylactic platelet transfusion. Patients will be followed for any~     bleeding events, need for platelet transfusion, and any side effects experienced. Patients~     will complete questionnaires to assess their quality of life while on the study.~   "
75095|NCT02074397|"~     The objective of this randomized controlled trial is to compare the analgesic efficacy and~     the safety profile between two techniques of injection for the interscalene block. The~     interscalene block consists of injecting local anesthetic around the cervical roots of the~     brachial plexus and allows analgesia after shoulder surgery.~      Stated differently, the dual objective of that study is:~        1. to confirm that an injection at a distance of 4 mm away from the lateral sheath of the~          plexus (distal injection) provides similar analgesia as a classical injection within~          the plexus (subfascial injection);~        2. to demonstrate that a distant extrafascial injection produces less respiratory~          complications than a subfascial injection, defined as hemidiaphragmatic paresis.~   "
75096|NCT02074384|"~     International Diabetes Center (IDC) proposes a preference and usability study of glucose~     data acquisition and reporting, evaluating streamlined standardized cloud-based glucose~     reporting including work flow as well as patient and clinician preference at Type 1 Diabetes~     (T1D) Exchange sites to enhance standard Ambulatory Glucose Profile (AGP) reporting. This~     phase 2 project assesses the efficacy of standardized glucose data report generation and~     preferred report presentation format; both are necessary to increase use of continuous~     glucose monitoring (CGM) data to improve care processes and outcomes for Type 1 diabetes.~   "
75097|NCT02074371|"~     Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory~     depression. In this study we aimed at investigating perioperative parameters that could~     predict the nadir of postoperative respiratory function impairment.~   "
75098|NCT02074358|"~     The purpose of this study is to assess the effect of two 4-Factor PCC formulations on~     Apixaban pharmacodynamics in healthy adult subjects.~   "
75099|NCT02074345|"~     The purpose of this study is to evaluate the safety and immunogenicity of intramuscular~     TAK-816 in healthy Japanese infants.~   "
75100|NCT02074332|"~     The primary objective of this study is to assess the effectiveness of a school based~     physical activity programme on obesity and related health outcomes in young schoolchildren.~   "
75101|NCT02074319|"~     The aim of the this study is to evaluate the effectiveness of methotrexate added to~     treatment as usual on positive and negative symptoms, cognitive and social functioning and~     quality of life of patients suffering from schizophrenia.~   "
75102|NCT02074306|"~     The purpose of this study is to examine the effect of UROSHIELD® (a device which generates~     low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in~     patient receiving mechanical ventilation, and to determine whether this device lowers the~     rate of bacterial resistance to antibiotics.~   "
75103|NCT02074293|"~     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they~     are typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
75104|NCT02074280|"~     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and~     increased intestinal permeability all leading to an increase in bacterial translocation and~     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral~     administration and exhibits broad spectrum antimicrobial activity against both aerobic and~     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.~     It has been suggested that oral prophylactic antibiotics or bowel decontamination might~     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore~     the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of~     advanced cirrhosis.~   "
75105|NCT02074267|"~     The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in~     patients with neuropathy pain.~   "
75106|NCT02074254|"~     Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake~     Inhibitors~   "
75107|NCT02074241|"~     The purpose of this study is to try to figure out some bio-markers of chemosensitivity for~     adjuvant chemotherapy for bladder cancer.~   "
75108|NCT02074228|"~     Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity~     and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term~     impairing disorder with tremendous impact on individuals, families, and societies. It~     affects 5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults.~     Although the efficacy of medications for ADHD is well demonstrated in clinical trials,~     substantial numbers of patients fail to remain on therapy, and there is tremendous~     variability in tolerability and treatment acceptance. It is of great interest to identify~     biomarkers relating to medication response in ADHD. However, the procedure for obtaining~     central markers such as PET scan is invasive and expensive. Previous studies have found that~     mRNA expression of neurochemical markers in circulating blood can reflect the neurochemical~     levels in the brain. Further studies to identify peripheral biomarkers related to medication~     response in ADHD are warranted.~   "
75109|NCT02074215|"~     Recent studies have shown that aerobic exercises and dual-task training are effective in~     improving overall cognitive function in patients with cognitive impairment or dementia.~     However, the biological mechanisms are unknown in humans. It also remains unclear regarding~     whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three~     main purposes of this study are: (1) to investigate the effects of a 3-month aerobic~     exercises combined with dual-task training on memory and executive cognitive functions in~     patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease~     (AD); (2) to compare the differences in training effects between patients who carry APOEε4~     genotype and those who do not carry this genotype; and (3) to investigate the biological~     mechanisms of the exercise training effects on memory and executive cognitive function in~     these patients. The biological mechanisms of interest will include the blood Aβ1-40 and~     Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and~     cerebral blood flow.~      We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or~     AD will be recruited. The participants will be randomly assigned to the experimental group~     or the control group. Both groups will receive three 90-minute exercise sessions per week~     for 12 weeks. For the experimental group, the exercise program will include moderate~     intensity aerobic exercises and dual-task training; whereas for the control group, the~     training program will include gentle stretching exercises. Both groups will receive~     examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting~     glucose, cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function,~     and dual task performance at baseline, post-training, and after a 3-month follow-up period.~     Differences on the aforementioned outcomes brought by the 12-week training programs will be~     compared between the experimental and control groups. Exercise effects between patients who~     carry APOEε4 genotype and those who do not will also be examined.~      Results of this study will provide relevant clinical evidence for the effects of aerobic~     exercises combined with dual-task training on patients with MCI and mild AD; and will~     provide further understanding of the mechanisms mediating these effects.~   "
88176|NCT01903148|"~     The purpose of this study is to evaluate the impact of the last recommendations of the~     European Anemia Working Group ERBP in the anemia management in the achievement of the~     therapeutic goal of Hb 11-12 g/dL.~   "
75110|NCT02074202|"~     Liver cancer is a major cause of death among patients of east or southeast asian descent, as~     well as other population groups, notably in central and west Africa. Diagnosis of liver~     cancer requires a combination of several imaging techniques and biopsies. Despite this,~     diagnosis can remain inconclusive or difficult to establish in patients at risk for liver~     cancer.~      The purpose of this multi-center trial is to evaluate novel imaging methods developed to~     diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use~     novel imaging probes that have been reported to bind to liver cancers but not benign liver~     lesions that can be confused with liver cancer. Two such imaging probes will be evaluated.~     2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely~     used for cancer imaging with a device called positron emission tomography, or PET scans. We~     already know that [18F]FDG cannot detect some liver cancers that are slow growing.~     [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly~     effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection~     rate by using [18F]FCH alone or in combination with [18F]FDG.~      We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years.~     The results will be correlated with those of biopsies and clinical follow-up.~      This study will provide valuable data on whether these imaging agents can successfully~     differentiate malignant liver lesions from benign ones. It will also provide information~     about whether these imaging agents can successfully assess whether the cancer has spread~     outside the liver. It will provide data that will allow physicians to determine the optimal~     imaging protocol to properly diagnose liver cancer.~   "
75111|NCT02074189|"~     Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy~     for locally advanced bladder cancer.~   "
75112|NCT02074176|"~     Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly~     heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on~     individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan.~     Emerging evidence has suggested that patients with ADHD may present with a deficit of~     attention, alertness and sleep disturbances. Since attention, alertness, and sleep~     disturbances may significantly increase the functional impairment of ADHD, gaining insight~     into their pathophysiology as well as into their treatment is of relevance to provide a~     better clinical management of patients suffering from ADHD. The orexin system, located in~     the hypothalamus, takes an important role in homeostatic functions, such as attention,~     alertness, sleep-wake cycle, and feeding. To our best knowledge, the functioning of the~     orexin system has never been investigated in patients with ADHD. Given the involvement of~     the orexin system in the control of alertness and reward seeking, the present study aims to~     examine whether plasma orexin and mRNA expression levels of pre-pro-orexin gene are~     associated with the symptoms and neurocognitive deficits of ADHD.~   "
75113|NCT02074163|"~     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they~     are typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
75114|NCT02074150|"~     Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are~     typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
75115|NCT02074137|"~     Primary Objective:~      To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone~     refractory prostate cancer~      Secondary Objectives:~        1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for~          the treatment of patients with metastatic Hormone Refractory Prostate Cancer~        2. To describe patient profile in terms of demography, disease characteristics and prior~          treatment history~        3. To describe efficacy outcomes: radiological response (if available) using Recist~          criteria V 1.1 and Prostate Specific Antigen (PSA) response~   "
75116|NCT02074124|"~     The aim of this study was to investigate changes in abdominal tissue perfusion during~     adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by~     changes in the circulatory system mediated by adenosine, and a more differentiated~     assessment of the circulatory capacity of abdominal tumours could be achieved by sequential~     rest and adenosine vasodilation CT perfusion measurements.~   "
75117|NCT02074111|"~     The aim of this study is to investigate the proportion of patients with moyamoya disease~     among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do~     this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up~     angiography are performed during follow up (in selected patients).~   "
75118|NCT02074098|"~     The purpose of this study is to determine whether a bed height make an effect to~     endotracheal intubation with Macintosh laryngoscope, Glidescope and Airwayscope during chest~     compressions in- hospital simulation cardiac arrest.~   "
75119|NCT02074085|"~     An ADE is defined as harm caused by a drug or the inappropriate use of a drug. Retrospective~     record reviews in several countries have shown that anticoagulants frequently lead to~     hospital readmissions. In this study a hospital readmission is defined as an admission to~     the emergency department of the Jessa hospital. The objective of this study is to determine~     the incidence of one week and 30-day readmissions caused by (preventable) ADE's due to~     anticoagulants.~   "
75120|NCT02074072|"~     European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high~     quality chest compressions .They propose minor changes for pregnant women: manual left~     deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the~     inferior vena cava. We will examine the performance of the Glidescope (GVL), the Pentax-AWS~     Airwayscope(AWS) and Macintosh laryngoscope (McL) for airway management during chest~     compressions on 15 and 30 degree left-lateral tilt (15 &30 LLT) custom-made hard wedges.~   "
76223|NCT02059616|"~     The purpose of this study is to explore the optimal dose of fixed-dose combination of~     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the~     combination therapy compared to each of the monotherapy in patients with essential~     hypertension.~   "
75122|NCT02074046|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
75123|NCT02074033|"~     The infection is a major risk to hospitalized patients, especially those admitted to the~     Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill~     patients, increasing costs and prolonging hospitalization hospitalar. The~     ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection~     in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high~     rate of PAV and mortality related to it, is very important both prescription and~     administration of antibiotics correctly, as deescalation or escalation according the result~     of cultures.Therefore, the objectives of this study is assess if whether the antibiotic~     prescribed of ventilator-associated pneumonia following the orientation of literature. Will~     also be assessed the rate of PAV in patients critically ill adults, the main microorganisms~     responsible by PAV and determining antimicrobial susceptibility.~   "
75124|NCT02074020|"~     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by~     a composite responder index in subjects who, despite corticosteroid use, continue to have~     autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by~     SELENA SLEDAI score ≥10.~   "
75125|NCT02074007|"~     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear~     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The~     patient or caregiver will measure the amount of ear pain before and after the ear drops to~     establish if the medicated ear drops decrease the amount of pain more than the placebo ear~     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can~     be used up to 4 days, as needed for ear pain.~   "
75126|NCT02073994|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma,~     that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase~     where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum~     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study~     is a dose expansion phase where four arms of patients will receive AG-120 to further~     evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose.~     Anticipated time on study treatment is until disease progression, unacceptable toxicity~     occurs or at Investigator discretion.~   "
75127|NCT02073981|"~     This study is implemented to identify factors having an impact on improvement or~     exacerbation of non-motor symptoms, to provide information contributing to development of~     medical care in this field and improvement of patients' QOL, and to clarify the association~     between the use of istradefylline and non-motor symptoms or QOL.~   "
75128|NCT02073968|"~     This phase II trial studies how well intensity modulated radiation therapy adjusted by~     positron emission tomography (PET) scanning together with combination chemotherapy works in~     treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy~     uses high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple~     beam angles and dozens of beam segments are used to deliver highly conformal radiation~     therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more~     tumor cells.~   "
75129|NCT02073955|"~     This is a validation study. A stroke symptom questionnaire will be adapted and translated~     into local language. Two community health workers will be trained in its administration.~     Their findings will be validated against assessment by two neurologists.~      The study hypothesis is that the chance corrected agreement between the community worker~     administered stroke symptom questionnaire and the assessment by neurologist based on history~     and physical examination is at least moderate.~   "
75130|NCT02073942|"~     The wearable cardiac defibrillator (WCD) is an alternative to the implantation of~     cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly~     bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective~     register for all patient with an indication of wearable defibrillator.~   "
75131|NCT02073929|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated~     with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.~      The study investigates the effect af intervention with GLP-1-analog on risk markers of~     cardiovascular disease in women with PCOS.~      70 women will be included in af RCT.~      Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a~     beneficial reduction in risk markers of vascular thrombosis and early cardiovascular~     disease.~   "
75198|NCT02073058|"~     The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based~     Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood~     Glucose (BG) reference using the Consensus Error Grid. During the course of the wear~     duration, the subject is required to test fingerstick glucose measurement at least eight (8)~     times a day for capillary reference glucose measurements and three in-clinic visits of a~     maximum 13 hours each for venous reference glucose measurements. With every reference~     measurement, the subject or study staff will perform a measurement on the System.~   "
75199|NCT02073045|"~     This pilot clinical trial studies intensive education in increasing understanding of~     lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of~     fluids in the arm (or other extremity) after surgery. Providing written educational handouts~     and verbal education on the risk factors and symptoms of lymphedema may improve patients'~     ability to identify symptoms of lymphedema after surgery.~   "
75132|NCT02073916|"~     This open-label, single-center study will assess the safety and tolerability of combining~     trastuzumab emtansine (T-DM1) to Lapatinib and Abraxane in patients with metastatic~     HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle~     and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily.~     Anticipated time on study treatment is up to 12 weeks for patients metastatic breast cancer,~     until disease progression or unacceptable toxicity occurs. Subjects may continue on~     treatment past 12 weeks if responding to study treatment.~      The purpose of this study is to test the safety of Trastuzumab Emtansine in combination with~     Abraxane and Lapatinib at different dose levels. The investigators are proposing in this~     phase Ib study to assess the maximum tolerated dose (MTD) of Trastuzumab Emtansine in~     combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.~      The investigators hypothesize that combining antibody-drug conjugate trastuzumab-emtansine~     and lapatinib together with Abraxane will improve clinical efficacy by affecting both PI3K~     and ERK1,2 MAPK pathways.~   "
75133|NCT02073903|"~     The purpose of this study is to introduce new technology and interpreter practices in the~     inpatient setting at MSKCC. We plan to install dual handset phones at the bedsides of~     limited English proficiency (LEP) patients and to assess the impact on both patient and~     physician communication effectiveness with this technology.~   "
75134|NCT02073890|"~     Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and~     pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid~     haemorrhage refers to blood in subarachnoid space that lies between arachnoid and~     piameninges, covering brain. It is often associated with concurrent intracranial injury~     component. Individuals at higher risk for tSAH are those who are at higher risk for blunt~     head trauma. This includes adolescents, low-income individuals, men, and individuals with a~     history of substance abuse. The investigators present study aims to investigate prognostic~     factors associated with the neurological outcome among patients of post traumatic SAH.~   "
75135|NCT02073877|"~     The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound~     processor. The system provides a hearing solution for a subgroup of patients who cannot~     sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to~     40%) of associated peri-implant dermatitis. This research project is part of an attempt to~     reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the~     skin flora in relation to infection around the abutment using a standard culture which~     yielded limited and no clinically relevant results, little is known about the microbiome on~     the abutment or its interaction with the commensal skin flora. Moreover, conventional~     cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced~     IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This~     technology was devised to enable high-throughput molecular fingerprinting of microbioma.~     Since IS-pro is quick and relatively inexpensive, these environments can also be monitored~     over time by repeating the test. This paves the way for researching the microbiome on the~     abutment and it could enable clinically objective follow up of treatments in vivo using the~     human as a host. This technique allows researchers to even discover unknown, previously~     unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the~     spatial distribution and composition of bacteria on the abutment. The first step, using~     these techniques, is to determine the bacteria which inhabit the abutment also in relation~     to the surrounding skin. Additionally, the relationship with skin-implant infections and the~     effect of treatments will be monitored. Depending on these primary scientific results, a~     subsequent study will be devised to study (experimental) treatments in a randomized,~     controlled fashion.~      Objectives of the study:~        1. To identify the bacterial flora on the abutment in a phylum/species classification.~        2. To assess the relationships between the commensal skin flora and the flora on the~          abutment and to study if clinical signs of peri-implant skin infection and subsequent~          treatment are associated with a change in bacterial composition.~        3. To assess if there exists a relationship between skin hygiene and the transient skin~          flora.~   "
75136|NCT02073864|"~     A prospective, multi-center study to evaluate the neuro-embolic consequences of~     Transcatheter Aortic Valve Replacement (TAVR)~   "
75137|NCT02073851|"~     Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands.~     Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the~     duration of the TAVR procedure.~   "
75138|NCT02073838|"~     This is a research study of ribavirin which will be given in combination with vismodegib~     and/or decitabine. The purpose of this study is to see if patients respond to treatment when~     ribavirin is given with vismodegib alone or in combination with decitabine.~   "
75139|NCT02073825|"~     The purpose of this study is to adapt and pilot-test a web-based intervention intended to~     help concerned partners provide support to service members with alcohol misuse and to begin~     development of a service member module based on service member's input.~   "
75140|NCT02073812|"~     RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem~     (RPX2014) to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
75141|NCT02073799|"~     Recent literature indicated that postoperative storage symptoms after Photoselective~     vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were~     often reported and generally more common than after transurethral prostatectomy (TURP).~     However, almost all literature focused on postoperative urgency or dysuria immediately after~     PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms~     in the postoperative period after PVP or HoLEP and data on predicting factors that influence~     improvement in storage symptoms postoperatively. The aim of this study was to compare serial~     changes of postoperative storage symptoms between PVP and HoLEP, and to identify the~     predictors that influence improvement of storage symptoms postoperatively.~   "
75142|NCT02073786|"~     Lightwand is a useful alternative device for intubation but scooping movement can induce~     damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is~     rigid video stylet which has camera on distal tip of device. In many previous studies, rigid~     video stylet has proven advantages compared with other intubating devices.~   "
75143|NCT02073773|"~     The present proposal aims to assess whether a combined rehabilitation approach using virtual~     reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard~     rehabilitative occupational therapy and physiotherapy will lead to signifcantly better~     outcomes for stroke recovery.~      It is a randomised controlled trial with blinding of the assessors only. It will be~     preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only.~     Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be~     randomized, through a computer-based random number generator, to either one of two treatment~     arms:~        1. Control occupational therapy + pharmacotherapy for 2 weeks~        2. Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks~   "
75144|NCT02073760|"~     The investigators will conduct qualitative interviews of hospital personnel regarding HAI~     prevention practices, and use coded data from these interviews to assist in developing~     standardized practices.~   "
75148|NCT02073708|"~     One out of ten adults and up to 20 % of children in Northern Europe are diagnosed with~     asthma. Patients with onset of disease in childhood and patients with adult-onset asthma~     have in common that their symptoms can be aggravated by exposures in the workplace. Work~     exacerbated asthma (WEA) is defined as worsening of asthma due to conditions at work and is~     common with a median prevalence of 22 %. However, additional research is needed to improve~     the understanding of the risk factors, mechanisms and outcomes of WEA. Studies of difference~     in response to exposures between subgroups of asthma patients may provide new insight also~     into the phenotypic heterogeneity of asthma.~      The primary aim of the study is to estimate the incidence rate of asthma in relation to age,~     sex, socioeconomic factors and occupational exposures in a prospective study. Recently, data~     on respiratory symptoms and physician diagnosed asthma has been collected from 16.300~     inhabitants of Telemark County (baseline study). A random sample from the baseline sample of~     1000 asthma cases and 1000 controls will be asked to participate in a medical examination in~     which blood pressure, lung function and Fraction of exhaled nitric oxide (FeNO) will be~     measured. In addition, blood samples will be collected form analysis of inflammatory markers~     and gene sequencing. The case-control study will be repeated after five years and ten years,~     if founded (5- and 10-year follow-up).~   "
75149|NCT02073695|"~     Research question:~      Do patients using a neutral rotation brace post surgery have improved functional outcome and~     external rotation of the shoulder compared to current best practice using a polysling~     holding the proximal humerus in internal rotation?~      Primary objectives:~      To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months~     and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks~     and 1 year) between patients held in neutral versus current standard rotation. These will be~     compared to scores taken pre-operatively.~      Benefits:~      There may be no extra benefits to patients from this trial however the results from the~     trial will help improve treatment for future patients at this hospital, and others across~     the country.~      Risks/disadvantages:~      The operation is the same in both groups studied, the study is investigating the use of the~     two different slings. The post-operative treatment is also the same, and all patients on the~     trial will receive the same amount of physiotherapy. It isn't anticipated that there will be~     any additional risk from this trial.~   "
75150|NCT02073682|"~     Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an~     initial index event in cancer subjects.~   "
75151|NCT02073669|"~     The aim of study is to evaluate the prevalence of latent TB in second generation immigrants~     from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the~     control native Israelis without a family member who was born in a country with high~     incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the~     investigators expect that the second generation immigrants group will have more positive~     IGRA test than the control native group.~   "
75152|NCT02073656|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in~     hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment~     intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with~     HIV-1.~      Participants who experience confirmed post-treatment virologic failure (relapse) at or~     before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to~     receive LDV/SOF plus ribavirin (RBV) for 24 weeks.~   "
75153|NCT02073643|"~     This project examines behavioral and household characteristics associated with food~     purchasing patterns.~   "
75154|NCT02073630|"~     Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a~     manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal~     and human experiments that the cerebellum plays a prominent role in the pathophysiology of~     dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia,~     resulting in a decoupling of the motor component from the afferent information flow~     resulting from changes in the environment. An overall loss of gabaergic-mediated inhibition~     is at the forefront in dynamic changes in neural circuitry described in dystonia. In the~     mature brain gabaergic control the generation of temporal synchronies and oscillations in~     the glutamatergic neurons. Taken these all together with the results of a pilot experiment,~     the investigators hypothesize that deficient synchronies in the fast gamma range are one of~     the key mechanisms leading to abnormal communication inside the cerebello-cortical network~     in dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto~     encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma~     oscillations in the nodes of the cerebello-cortical network. The investigators then aim to~     re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the~     cerebellum at high gamma frequency a non invasive transcranial alternative current~     stimulation.~   "
75155|NCT02073617|"~     The American College of Cardiology/American Heart Association guidelines place symptomatic~     severe Aortic Stenosis as a class I indication for aortic valve replacement. With the~     recently approved Edwards-Sapien TAVR device and the ongoing investigations using the~     CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now~     eligible to undergo TAVR.~      Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic~     valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography~     to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which~     may result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of~     patients depending on associated clinical risk factors.~      There is a need to consolidate this pre-operative testing whenever possible, and with~     real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac~     acquisition in the cath lab angiography suite during the coronary angiography, there may be~     a benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA).~      We would like to make a comparison of aortic valve and root measurements using CTA and~     DynaCT to affirm the accuracy of DynaCT vs the CTA gold standard.~   "
75252|NCT02072356|"~     This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in~     treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy~     uses radioactive material placed directly into or near a tumor to kill tumor cells. Using~     radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.~   "
75156|NCT02073604|"~     The aim of the project is to study the role of secondary motor area (more precisely the~     supplementary motor area, or SMA) during unimanual and bimanual voluntary movements~     externally (cue) or internally (subject's choice) triggered. In that view, we will study 3~     experimental groups :~        -  a group of healthy volunteers (control group)~        -  the same group of healthy volunteers after a transient inactivation of the SMA (by the~          aim of repetitive trans cranial magnetic stimulation or TMS)~        -  a group of patients suffering from congenital mirror movements who are suspected to~          present a dysfunction of the SMA (according to our previous results) In each of these~          groups, by the aim of a serial reaction time task, we will study the influence of a SMA~          stimulation on the excitability of the primary motor cortex (M1) during the preparation~          of a voluntary movement (unimanual or bimanual). This will allow us to assess the~          communication between the SMA and M1 during movement preparation. Using the same task~          in functional imagery, we will study the activation's pattern of primary and secondary~          motor areas during movement preparation. This multimodal approach should allow us to~          better understand the synergistic functioning of these different structures involved in~          movement preparation. An other interesting aspect will be to determine the role of~          these structures in movement lateralization. Eventually, our results might allow us to~          precise to role of the motor preparation's dysfunction in the genesis of congenital~          mirror movements.~      In the first place, this study aims at a better understanding of the cerebral physiology of~     movement preparation (which is not well known) using the mirror movements paradigm as a~     dysfunction model (according to our previous results). According to our hypothesis, there is~     a strong link between the SMA and M1 during movement preparation. This hypothesis will be~     assessed by the use of the same experimental task with combined neurophysiological and~     neuroimaging approaches, thus increasing the validity of the results obtained.~      A secondary aim of this protocol is to precise the role of motor planning dysfunction in~     patients with congenital mirror movements. A better understanding of the mechanisms~     responsible for this condition is necessary in a medium-term therapeutic prospect.~   "
75157|NCT02073591|"~     This is a prospective, open label, single arm, and observational and multicenter study to~     assess the correlation between PEST and SCORAD scores in the management of AD with the~     Ceradan® regimen.~   "
75158|NCT02073578|"~     This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be~     recruited for this trial, with the intent to treat 20 patients.~   "
75159|NCT02073565|"~     This is a multi-center, single-blind, randomized, active-controlled, clinical trial in~     Percutaneous Coronary Intervention [PCI] subjects. Subjects will be randomized to receive~     the Combo stent as the investigational treatment arm or an EES as the active-control arm.~   "
75160|NCT02073552|"~     The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus~     ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume~     polyethylene glycol preparation in subjects with past history of poor bowel preparation~   "
75161|NCT02073539|"~     Chest compression (CC) feedback devices are used to perform CC measurements effectively and~     accurately on patients in hospital beds. However, these devices do not take account of the~     compression of the mattress, which results in overestimation of CC depth. This study is the~     validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful~     to overcome this limitation and thus measure compression depth more accurately when~     performing cardiopulmonary resuscitation (CPR) on patients.~   "
75162|NCT02073526|"~     Drug serum concentrations will be measured at several time-points for inflammatory disease~     patients treated with anti-TNF agents. The purpose is to determine which patients that will~     clinically benefit from either discontinue treatment, adjusting the dose, switch to another~     anti-TNF agent or a different class of medication.~   "
75163|NCT02073513|"~     BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input~     in the children with cerebral palsy who have spasticity in their hands.~      OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and~     without pressure on hand function in children with cerebral palsy. METHOD: 45 children were~     randomly allocated to one of the thenar taping groups either with or without pressure or to~     the control group. Nine hole peg test and nine parts puzzle test were used to measure hand~     function. The two study groups were evaluated initially, with taping 20 minutes later and 20~     minutes after taping was removed.~   "
75164|NCT02073500|"~     The aim of this study is to identify biomarkers of disease recurrence and prognosis to~     optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic~     intraperitoneal chemotherapy (HIPEC), and through animal models to explore different~     treatment strategies for peritoneal surface malignancies (PSM).~   "
75165|NCT02073487|"~     Purpose: The purpose of this study is to evaluate the Pathological Complete Response (pCR)~     of the breast when trastuzumab emtansine (TDM-1) plus Lapatinib plus Abraxane is combined in~     newly diagnosed HER2 positive breast cancer.~      This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of~     neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus~     trastuzumab (herceptin) plus Pertuzumab follow by paclitaxel.~   "
75166|NCT02073474|"~     The purpose of this registry is to monitor safety outcomes of patients who are receiving~     Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United~     Kingdom (UK), Germany and Sweden.~   "
75167|NCT02073461|"~     This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and~     5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.~   "
75168|NCT02073448|"~     This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of~     CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the~     treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.~   "
75169|NCT02073435|"~     Living donor liver transplantation (LDLT), involves complex systems and processes of care~     that are particularly vulnerable to medical errors and preventable complications. This~     ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will~     focus on conducting a proactive, systematic, and comprehensive assessment of the~     vulnerabilities in the systems and process of LDLT care to reduce medical errors and~     preventable complications thereby improving the safety of LDLT care. This project will~     address an important gap in the knowledge needed to achieve high quality and safe LDLT care~     of patients by developing a process to: 1) proactively, systematically and comprehensively~     identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design~     and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of~     these solutions to improve the safety of LDLT care by measuring clinical and process~     outcomes before and after solution implementation across four A2ALL participating transplant~     centers~   "
75200|NCT02073032|"~     The main objective of this observational survey was to determine the incidence rate of~     refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any~     decline in p-phosphate with additional development of any of the following clinical~     symptoms: oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently~     admitted or referred HNC patients to the Department of Otorhinolaryngology for surgery. The~     second objective was to determine if informations at admittance could identify HNC patients~     at high risk of developing RFF and RFS.~   "
75170|NCT02073422|"~     BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) is the commonest type of~     acute coronary syndrome (ACS) and has a poor long-term prognosis. Guidewire-based coronary~     pressure measurement of the myocardial fractional flow reserve (FFR) is validated for~     measuring the severity of a coronary lesion narrowing in patients with stable angina. FFR~     measurement in patients with a recent ACS has theoretical limitations and is not fully~     validated.~      AIM: To prospectively assess heart muscle blood flow and injury with guide-wire based~     methods at the time of the clinically-indicated angiogram and compare these results with~     those from a stress perfusion MRI scan in medically-stabilised NSTEMI..~      HYPOTHESIS: 1) FFR measured invasively will correspond closely with findings from stress~     perfusion MRI, 2) MRI will provide clinically-relevant information on heart muscle injury,~     function and salvage, 3) Guidewire-derived measurements of coronary microvascular function~     will be associated with the MRI findings.~      DESIGN: The MRI study will be performed in patients who give informed consent in the~     FAMOUS-NSTEMI clinical trial (NCT registration 01764334). All of the clinical data for these~     participants will be available to link with the MRI results.~   "
75171|NCT02073409|"~     Isolation of an nontuberculous mycobacteria (NTM) from sputa of cystic fibrosis (CF)~     patients is relatively common, and of uncertain significance. At the request of the CF~     Foundation (CFF), the Investigators have designed a standardized diagnostic protocol based~     on current recommendations for the diagnosis of NTM by the American Thoracic Society, as~     well as forthcoming recommendations by the CFF and the European CF Society. The study is~     observational in nature, and is not intended to change the current diagnostic approach to~     the infection, but rather standardized the collection of data to facilitate the decision~     making process. When validated, this protocol will be easily assessable to the entire CFF~     Care Center Network.~   "
75172|NCT02073396|"~     Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased~     risk of stroke and heart attack. Such events are usually caused by increased stickiness of~     the blood causing a blood clot to block the artery (thrombus) in the heart or the brain. The~     aim of this study is to assess the stickiness of the blood (global thrombotic status) in~     patients with CAD and AF at baseline and after clinical stabilisation to see how disease~     state and clinical treatments affect the stickiness of the blood (thrombotic status). This~     will be a single centre study. Patients diagnosed with CAD or AF will have a blood sample~     taken at baseline and after clinical stabilisation. Blood stickiness will be tested with the~     Global Thrombosis Test. The results will be evaluated to assess the effect of disease~     process and clinical state on blood stickiness to gain further understanding of this~     condition and form the basis for future studies aimed at identifying patients who are at~     high risk of future cardiovascular events, based on increased blood stickiness.~   "
75173|NCT02073383|"~     The brachial plexus block is an anesthetic technique often used for surgical procedures of~     the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques~     most commonly used to obtain regional anesthesia of the upper limbs, being performed by~     anesthesia of the terminal branches of the brachial plexus, which would be the ulnar,~     median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can~     be used to perform the BPVA . The first , known as multiple puncture technique , the local~     anesthetic is deposited around each nerve that want to block . This technique is most~     commonly used to perform the BPVA . The second technique , known as 2 injections , local~     anesthetic is deposited below the axillary artery and around the musculocutaneous nerve .~     This technique has been proposed to try to reduce the execution time of anesthesia . Studies~     actually show that the technique of 2 injections showed less time to perform the block, with~     the same success rate. However, the technique of 2 injections showed a longer latency and~     higher rate of vascular puncture . (14) In order to perform a procedure with shorter~     execution time , without changing the latency, success rate and ensuring patient safety ,~     the investigators designed this protocol to evaluate three techniques for performing the~     ultrasound- guided axillary brachial plexus block.~   "
75174|NCT02073370|"~     Sarcopenia related mobility dysfunction was a preventable presentation in transitional~     variation of frailty. However, the definition, associated risk factors, clinical course and~     outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for~     further study.~   "
75175|NCT02073357|"~     General anaesthesia is a reversible drug-induced coma. Too little can result in patients~     being partially conscious during surgery; too much can slow recovery after surgery. There is~     a range of drug doses that can be used and some anesthesiologists use more than others.~     There is no convincing evidence that any particular dose within the usual range is better.~     Consequently, there are no guidelines on the best depth of anaesthesia. This study will~     determine whether general anesthetic concentrations at the low end of the usual range are~     better than those at the high end.~      Participants will randomly be assigned to lighter or deeper general anesthesia. The first~     day after surgery, two short questionnaires about recovery and memories of the surgery will~     be completed. During the rest of the participant's hospital stay, a survey about how one~     feels will be completed.~      There will be two telephone contacts after discharge from the hospital. One month after~     surgery three questionnaires will be completed about performing daily tasks, how you feel~     and memories of the surgery. Then one year after surgery pain will be assessed.~   "
75176|NCT02073344|"~     The purpose of this study is to investigate the effect of beginning a renal replacement~     therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in~     patients with end stage chronic kidney disease. It aims further to investigate the~     relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep~     apnea.~   "
75177|NCT02073331|"~     The objective of the study is to actively gather additional information on the use of~     CorMatrix ECM for pericardial reconstruction.~   "
75178|NCT02073318|"~     Purpose -To investigate whether older adults with dementia who have balance and gait~     problems can improve their balance and gait function after an individualized 4-week~     tasks-oriented balance training with sensory manipulation.~      Hypothesis~      -There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed,~     30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients~     who received tasks-oriented balance training and those didn't receive after 4-weeks training~     and one month follow-up.~   "
75180|NCT02073292|"~     Nerves in your body transmit signals to and from your brain and the cells in your body. In~     the event of an injury or disease, these nerves transmit pain. Sometimes, when an injury~     doesn't heal, chronic pain can develop. One way to treat chronic pain is to interrupt these~     pain signals. One method of doing this is to use Radio frequency ablation (RFA).~      Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high~     frequency electrical current in order to lesion (burn) nervous tissue. Radiofrequency~     ablation is used to treat many conditions in several areas of the body including cardiac~     (heart) as well as chronic pain. Probes (needles) are inserted into the body to a specific~     location and the electrical current is passed through these needles. This electrical current~     creates heat in your body and forms small lesions or burns in a specific place. Doctors will~     use tools, such as fluoroscopy (x-rays) and injections to locate the specific nerves that~     are transmitting pain and then use the electrical current to destroy those nerves.~      Equipment used include generator, built in nerve stimulator, different needles and probes~     and water cooling system in case of the cooled RFA.~      There are several types of probes or needles that are used to transmit energy and create~     lesions. This study is going to compare 2 types - standard radiofrequency and 'cooled'~     radiofrequency. The only difference is that the 'cooled' radiofrequency probes have water~     running through the probe tip, which keeps the tip cool and allows a larger lesion to be~     made. Since the doctor can't actually see the nerve he is trying to target, the larger~     lesion should theoretically improve his chances of hitting it. The 'cooling' of the water~     also allows the temperatures to be lower than what is needed for standard RF. In this study,~     the investigators would like to compare the differences between standard RFA (90°C) and~     cooled RFA (60°C) ablation techniques and determine if one is better for pain relief.~      All of the probes that are used to perform radiofrequency ablation are FDA approved and are~     commonly used to treat patients with chronic back pain.~      Participating in the study involves being randomly assigned to received either standard or~     cooled RFA. The procedure for both standard and cooled RFA is basically the same. The only~     difference is with standard RFA, the doctor may perform up to 2 lesions, instead of 1 if~     they are using cooled RFA.~      Both study groups will receive local anesthetic prior to procedure. The treating doctor will~     use a machine called a C-Arm to take x-rays. These x-rays will guide the doctor to be sure~     the probes are in the right place. Once the probe placement is confirmed, the doctor will~     turn on the generator and create the lesion. This process will be repeated depending on how~     many lesions need to be created.~      After the procedure there will be follow up visits at 1, 3 and 6 months. Level of pain,~     health and recovery information will be collected.~   "
75181|NCT02073279|"~     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,~     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD~   "
75182|NCT02073266|"~     The primary purpose of the study was to compare the macular hole closure and visual acuity~     gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning~     versus C3F8 gas tamponade with 14 days of face-down positioning.~      The secondary purpose was to report, in each group, the cumulative incidence of cataract~     development 1 year following macular hole surgery and the proportion of complications (*).~      ((*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This~     prospective randomized study examined a 3 year period. The first patient was included in~     January 2010 and the last in November 2011. The 12-month follow-up spread out from March~     2011 to December 2012. The first group included 31 patients who had undergone macular hole~     surgery using SF6 gas and who were advised to stay in face-down position for 7 days~     postoperatively (SF6 group). These patients were compared to 28 patients who had undergone~     macular hole surgery with C3F8 gas and who were advised to maintain a face-down position for~     14 days. Patients in both groups underwent vitrectomy, internal limiting membrane peeling,~     and fluid-gas exchange using either SF6 or C3F8.~      Preoperative data included the characterization of the hole with Optical Coherence~     Tomography (OCT), the best correct visual acuity (VA) recorded in number of letters using~     the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract~     according to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT~     confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in~     number of letters (EDTRS chart) and determination of cataract development and extraction as~     needed.~   "
75183|NCT02073253|"~     Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and~     increasing ventilator reserve in individuals with heart failure. Aim: To analyze~     thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after~     using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two~     experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30~     minutes of bi-level ventilation was performed. Any type of ventilator support was offered~     during control phase. Optoeletronic plethismography was performed to asses TK.~   "
75184|NCT02073240|"~     Study Design: Stratified, matched, cluster-randomized, controlled trial~      Unit of Randomization: Healthcare facility~      Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare~     workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among~     susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0~     (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and~     disseminated.~      Study Components: Assessment of institutional safety culture; observations/audits of~     Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices;~     documentation of time intervals for processing sputum smears and initiation of TB treatment;~     facility assessments; random allocation and implementation of enhanced Tuberculosis~     infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months;~     cost evaluation of intervention.~      Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will~     allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the~     intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control~     group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per~     cluster with 50% LTBI prevalence at baseline).~   "
75185|NCT02073227|"~     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two~     components combined in one tablet) of canagliflozin and metformin extended release (XR)~     tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of~     canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.~   "
75186|NCT02073214|"~     The purpose of this study was to evaluate the safety of a probiotic foodstuff and its~     influence on emergence and development of natural intestinal flora and the clinical status~     of premature very low birth weight neonates. The study was also intended to investigate~     reduction of colonisation by pathogenic bacteria and to estimate the incidence of~     gastrointestinal disorders.~      Probotic bacteria contained in the investigational product administered directly after birth~     are beneficial for the development of normal gut microflora and can prevent or significantly~     limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic~     flora in a hospital setting. Permanent colonisation with commensal flora in very early life~     improves gastrointestinal function in premature neonates by reducing the onset of or by~     decreasing the severity of the signs and symptoms of feeding intolerance and generalised~     bacterial infections, including sepsis and necrotizing enterocolitis.~   "
75201|NCT02073019|"~     The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective~     in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers~   "
75187|NCT02073201|"~     A primary focus of the University of Florida (UF) Claude D. Pepper Older Americans~     Independence Center (OAIC) is to build a comprehensive understanding of the causes and~     consequences of declining physical function and disability development among older adults.~     To date investigators have largely focused on sarcopenia, the age-related decline in~     skeletal muscle mass and strength, as the primary contributor to physical decline. However,~     recent findings indicate that changes in the central and/or peripheral nervous systems may~     play a larger role than previously thought in the development of functional limitations.~     These fields hold extensive promise for identifying novel contributors to age-related~     functional decline. Therefore, the overarching aim of this project is to develop the ability~     of RC1 to assess novel neural contributors to mobility and overall physical function.~     Importantly, the development of these techniques will provide the RC1 with the tools to~     evaluate the potential involvement of the central and peripheral nervous systems in~     age-related functional decline and disablement. The primary aim of this project is to~     develop techniques for quantifying peripheral motor unit number and size as well as spinal~     cord integrity.~   "
75188|NCT02073188|"~     The purpose of this study is to demonstrate the superiority of iBGstar as a component of the~     diabetes treatment vs. traditional blood glucose self-monitoring system for improving~     glycemic control after 6 months in young patients with type 1 diabetes. The study is~     intended also to demonstrate the superiority of iBGStar as a component of the diabetes~     treatment vs. usual blood glucose self-monitoring system for improving the compliance to~     self monitoring of blood glucose after 6 months.~   "
75189|NCT02073175|"~     The purpose of this study is to determine whether a dietary supplement (DS) is effective in~     protecting against sad mood in postpartum.~   "
75190|NCT02073162|"~     Physicians differ in their approaches to surgical fluid therapy, with some preferring higher~     volumes and others lower volumes. Each approach has potential advantages and disadvantages.~     Currently, there is no compelling evidence that one approach is better than the other. This~     study tests whether giving a volume on the low end of the usual amount (restrictive~     management) has a different rate of complications compared to a volume on the high end of~     the usual amount (liberal management). This study will compare liberal and restrictive~     fluid management to determine their effects on major complications after abdominal surgery.~      Those who take part in the study will be visited five times before and after surgery in the~     hospital. Once discharged from the hospital, participants will be called 4 times on the~     telephone.~      Preadmission Clinic/Preoperative Visit~        -  Sign the consent document~        -  Have blood drawn for standard preoperative tests (standard of care)~        -  Have an electrocardiogram (standard of care)~        -  Complete a questionnaire on disability (research)~      Day of Surgery~        -  Have blood drawn if not already done during the first visit (standard of care)~        -  Have an electrocardiogram if not already done during the first visit (standard of care)~        -  Be randomly assigned to either restrictive or liberal fluid management (research)~      Post-op Day 1~        -  Have an electrocardiogram done (research)~        -  Have blood drawn for standard tests (standard of care)~        -  Have a wound inspection, if there is a change of dressing (standard of care)~        -  Complete a questionnaire about your recovery (research)~      Post-op Day 3~        -  Have blood drawn for standard tests (standard of care) and c-reactive protein, which~          can indicate infection (for research).~        -  Have a wound inspection, if there is a change of dressing (standard of care)~        -  Complete a questionnaire about your recovery (research)~      Day of Discharge~        -  Have a wound inspection, if there is a change of dressing (standard of care)~           30-Day Follow-up Phone Call~        -  Complete a questionnaire about your recovery (research)~        -  Complete a questionnaire about disability (research)~           3 Month, 6-Month, and 12-Month Follow-up Phone Calls~        -  Complete a questionnaire about disability (research)~   "
75191|NCT02073149|"~     This study will determine whether the haemoglobin response to daily home fortification for~     30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous~     fumarate.~   "
75192|NCT02073136|"~     Patients with chronic kidney disease struggle to eliminate phosphate as the renal function~     deteriorates, which results in accumulation of phosphate in the body. This has been shown to~     increase the patients' risk of cardiovascular disease and death. Even with dialysis~     treatment the patients cannot excrete enough phosphate to reach phosphate balance. The~     patients are therefore recommended a very restrictive diet when they reach the dialysis~     stage. It is therefore important to find ways to prevent such accumulation of phosphate in~     the body as early in the disease process as possible, but without compromising the~     nutritional status. Because phosphate occurs naturally in many of our foods, such as meat,~     fish and dairy products, it is difficult to reduce the intake of phosphate, without also~     reducing the intake of energy and protein. Over the past couple of years there has been an~     increased focus on the use of phosphate containing additives in the food industry. A~     reduction in the intake of phosphorus containing additives may reduce the accumulation of~     phosphate in the body. This can be achieved by decreasing the intake of processed food~     products. Because it is also very time consuming and inconvenient for the patient to keep~     these strict diets, the patients have a reasonable claim to know which effects can be~     achieved by such diets. This will therefore seek to be further explored in the following~     study. The study is conducted as a randomised crossover trial in predialysis patients stage~     3-4.~   "
75193|NCT02073123|"~     To evaluate the preliminary efficacy of the established dose of indoximod in combination~     with immune checkpoint inhibition as measured by the best overall response rate (ORR)~     (complete response (CR) + partial response (PR))across both standard of care agents~     administered sequentially in patients with unresectable stage III or stage IV melanoma~   "
75194|NCT02073110|"~     Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal~     pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM)~     that are incidentally discovered by abdominal radiological imaging. However, 30% of resected~     SRMs appear benign on histological examination. Conventional biopsy is currently used to~     provide pathological information prior to resection. However, its non-diagnostic value is~     high, up to 33% in SRMs, showing the need for diagnostic improvement.~      The investigators have shown that optical biopsy (OB) can differentiate malignant from~     benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2~     clinical study. The investigators will use an OB probe that can be combined with a needle~     puncture during classical biopsy procedures, additionally providing real time micro-scale~     images containing quantitative information about tissue properties. The investigators are~     convinced that OB will greatly improve the diagnosis of renal tumor pathology.~   "
75195|NCT02073097|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with rituximab and combination chemotherapy and to see how well they work in~     treating patients with diffuse large B-cell lymphoma. Carfilzomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as rituximab, can block cancer growth by finding cancer cells and helping kill them.~     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. It is not known if carfilzomib in~     combination with R-CHOP is better or worse than R-CHOP alone in treating patients with~     diffuse large b-cell lymphoma.~   "
75196|NCT02073084|"~     The purpose of this study is to determine the effects of K-877 on ECG parameters with a~     focus on cardiac repolarization compared with placebo in healthy adult subjects.~   "
75197|NCT02073071|"~     This is a two stage open-label, single-arm, multicenter and observational study.~   "
75202|NCT02073006|"~     Constipation is common in the general population, especially in women and in the elderly.~     Hard stool is a complaint often associated with constipation, which suggests that stool~     softening would provide a major benefit in the strategy of treatment.~      This investigative fibre product is primarily a soluble dietary fibre with added probiotics~     and a prebiotic. It is not digested in the small intestine and partly remains undigested by~     bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora,~     reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the~     improvement of intestinal motility.~      The objective of this study is to assess if this investigative, fibre product effects the~     number of bowel movements per week and if this in turn impacts quality of life and symptoms~     of constipation.~   "
75203|NCT02072993|"~     This is a first time in human study to assess the safety and tolerability of AZD1979~     following oral administration of single ascending doses in healthy male volunteers.~     Pharmacokinetics (what the body does to the drug) parameters will also be assessed as~     secondary objectives.~   "
75204|NCT02072980|"~     The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1®~     (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.~   "
75205|NCT02072967|"~     Prospective multicenter observational non-interventional study to assess routine clinical~     practice of Bendamustine use in the second line therapy of relapsed or refractory indolent~     B-cell non-Hodgkin's lymphoma~   "
75206|NCT02072954|"~     To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg~     manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10~     mg.~   "
75207|NCT02072941|"~     In partnership with patients, caregivers, advocacy groups and clinicians, the investigators~     plan to:~      Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with~     Spanish-speaking Latinos and stakeholders.~      Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a~     previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:~      2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and~     discuss wishes with surrogates and clinicians and complete ADs) measured by self-report,~     chart review, surrogate reports, and~      2b. Direct observation.~      2c. Improve self-efficacy and satisfaction with medical decision making.~      2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and~     clinician-patient language concordance.~      Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.~   "
75208|NCT02072928|"~     This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in~     patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal~     injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical~     practice.~   "
75209|NCT02072915|"~     To compare the number of passes required for cellblock acquisition with and without suction~     using the 25g needle.~   "
75210|NCT02072902|"~     This is a large nationwide population study, with 10 year follow-up, of the effect of~     diabetes, metabolic control and a large number of glucose-lowering medications, on total and~     site-specific cancer incidence and survival.~      The study is based on electronic medical records from the largest Israeli health maintenance~     organization in Israel, Clalit Health Services. 2,301,990 insurees age 21 years old or above~     at study entry, January 2002 will be included. Four study groups will be established~     according to the prevalence of diabetes and/or cancer on that date: neither diabetes nor~     cancer; prevalent diabetes but not cancer; prevalent cancer but not diabetes; both diabetes~     and cancer prevalence. Subjects free of diabetes at study entry will be followed for~     diabetes incidence, and all four groups will be followed until December 2012 for study~     outcomes. The cohort data file will be linked to the Israel National Cancer Registry for~     cancer morbidity.~      We will compare, after adjustment, all and site-specific cancer rates between individuals~     with and without diabetes; and investigate if metabolic control, as indicated by HbA1c and~     blood glucose levels, is related to cancer risk. Using time-dependent Cox proportionate~     hazard models, we will then evaluate differences in outcomes that associate with the use of~     one or a combination of glucose-lowering treatments, while stratifying by those who were~     already diagnosed with diabetes at study entry, and those diagnosed during follow-up. Data~     for a large number of potential confounding variables, including BMI, plasma glucose, HbA1c,~     hormone replacement therapy and comorbidities will help mitigate allocation bias. The~     accessibility and uniformity of the healthcare provided by Clalit Health Services, as well~     as data on cancer screening tests, will minimize the risk of surveillance bias.~   "
75211|NCT02072889|"~     Measurements will be made between the internal jugular vein and the carotid artery using an~     ultrasound machine as the subjects is asked to move and position his or her neck in various~     positions.~      It is hypothesized that by movements of the neck the investigators can maximize the distance~     between the internal jugular vein and the carotid artery to decrease inadvertent cannulation~     of the carotid artery to improve patient safety~   "
75212|NCT02072876|"~     The incidence of stroke has increased by 100% in the last four decades in developing~     countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent~     causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive~     narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke~     from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited~     therapeutic options. Therefore, it is imperative to delineate the determinants of~     asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20%~     difference in the proportion of clinical, life-style (dietary, physical activity, obesity,~     smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than~     those with no ICAD.~   "
75213|NCT02072863|"~     The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of~     oprozomib in combination with melphalan and prednisone (OMP).~      The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and~     complete response rate (CRR) of the OMP combination.~   "
75233|NCT02072603|"~     The purpose of this study is to determine the effectiveness of the HITSystem in maximizing~     early infant diagnosis (EID) service utilization for HIV-exposed infants and early~     antiretroviral therapy (ART) initiation for infants diagnosed with HIV.~   "
75214|NCT02072850|"~     Heart imaging with magnetic resonance imaging (MRI) provides detailed insights into heart~     function and injury. The nature and significance of heart injury after a heart attack is~     incompletely understood. We propose a 'natural history' study of heart attack injury using~     contemporary MRI methods. In a large hospital in the West of Scotland, heart attack patients~     will be invited to have at least two MRI scans and also continue with life-long follow-up.~     The results from the MRI scans will be assessed with all of the other clinical information~     obtained at the time of the heart attack and during follow-up. The results of our study~     should provide new insights into heart attack injury and these results should help improve~     how heart attack patients should be treated.~   "
75215|NCT02072837|"~     In this study, we studied lipoprotein abnormalities-related variables as risk factors for~     the development of cardiovascular disease in patients on renal replacement therapies.We~     studied 96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24~     healthy controls.We concluded that metabolic acidosis activating the inflammation and~     lipoprotein oxidation influences the dyslipidemia and cardiovascular morbidity of patients~     on renal replacement therapies.Dialysis adequacy was positively associated to~     cardioprotective HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized~     lipids than hemodialysis modalities.~   "
75216|NCT02072824|"~     This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce~     seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with~     refractory partial onset seizures. It is hypothesized that both doses of pregabalin will~     demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure~     frequency and that pregabalin will be safe and well tolerated.~   "
75217|NCT02072811|"~     In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in~     individual patients must be individualized. One of the tools for this is~     molecular-cytogenetic stratification. It divides patients into five categories (prognostic~     groups): Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After~     remission proceedings are tailored depending on prognostic determined groups.~      Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved~     high effectiveness of this treatment with low toxicity. Considering experience of PALG~     groups, it seems that the use of the schema CLAG early as the second induction therapy is a~     viable treatment option.~   "
75218|NCT02072798|"~     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum~     infections compared to women undergoing vaginal delivery. In Denmark the incidence of~     post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract~     infections (UTI) and wound infections (WI).~      Prophylactic antibiotics are effective in preventing postoperative infections and national~     guidelines recommend that antibiotics should be administered as a single dose immediately~     before surgical incision. CS is an exception to this pre-incision administration approach.~     National guidelines recommend administration of antibiotics after umbilical cord clamping to~     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic~     prophylaxis for CS suggest that prophylactic antibiotics administered before incision~     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two~     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on~     the baby and on late infection in the mother.~      At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and~     simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation~     of the digestive and immune functions to avoid gut disorders and infections. Full-term,~     breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene~     levels, antibiotics treatment and formula feeding may inhibit immune development both short~     and long term. Birth by caesarean section in high-hygiene hospital environments, and~     widespread use of antibiotics, are factors that reduce gut microbiota density and diversity~     in the newborn for some time after birth. On the other hand, high-hygiene environments and~     antibiotics are essential tools to combat infections, especially for the weakest newborn~     infants.~      This pilot study will be a feasibility study to the original study, which examines the~     effect of change in timing of prophylactic antibiotics on the rate of post-CS infections~     (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut~     microbiota of newborn infants. The feasibility study will only include pregnant women in~     Odense with a body mass index below 30, and planned cesarean section.~   "
75219|NCT02072785|"~     The purpose of this study is to determine whether vincristine sulfate liposome could reduce~     less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine~     sulfate in adults with Naïve Acute Lymphoblastic Leukemia.~   "
75220|NCT02072772|"~     The purpose of this study is to determine whether Positively Smoke Free group therapy is~     more effective at promoting cessation than standard care.~   "
75221|NCT02072759|"~     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased~     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state~     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is~     an early hallmark in the development of diabetes. Recent evidence suggests that a low~     carnitine availability may limit acetylcarnitine formation, thereby reducing metabolic~     flexibility. We propose to test the hypothesis that metabolic inflexibility in pre-diabetic~     subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines.~   "
75222|NCT02072746|"~     The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's~     defensive barrier preventing damaging substances from reaching your liver, (2) decreases~     liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves~     your liver-related health. Based on our preliminary animal data and other published reports,~     we expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the~     counter or by prescription, and has an excellent safety profile. Positive results from this~     study will show that zinc is a significant therapy for millions of Americans with alcoholic~     liver disease.~   "
75223|NCT02072733|"~     A Feasibility study Geriatric assessment applied to patients with cancer of the head and~     neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of~     planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to~     patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is~     planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA~     to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in~     The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail,~     vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the~     planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict~     complications to cancer treatment within a three months period.~   "
75234|NCT02072590|"~     The main purpose of this study is to improve the diagnostics of celiac disease and reduce~     the need for invasive endoscopic studies in children. Further, the investigators aim to~     investigate the natural history and risk of complications in children with celiac disease or~     gluten sensitivity and to create a large scientific database.~   "
75224|NCT02072720|"~     The main question of this study is if and when VEGF (vascular endothelial growth factor)~     expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits~     subsequent vessel growth in the tumor.~        -  Therefore the first aim of this study is to identify the time point of induction of~          VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4~          weeks of chemoradiation).~        -  If we identify increased expression of VEGF at a certain time point, our second aim is~          to determine if we can inhibit the subsequent tumor vessel growth by administration of~          bevacizumab.~   "
75225|NCT02072707|"~     The investigators hypothesized that combined endocardial and epicardial VT ablation using~     contact sensor irrigated catheter is safe and achieves a lower recurrence rate than~     endocardial only ablation in ischemic and non-ischemic patients, for this the investigators~     will randomize 20 patients in two groups, one with endocardial only ablation and other with~     combined endocardial and epicardial ablation.~   "
75226|NCT02072694|"~     This study evaluates the hypothesis that a meal constituted of only glucose produces~     differences in the brain blood flow in people with obesity that are not observed in people~     without obesity. These changes, at least in part, could explain the mechanisms involved in~     maintenance or development of obesity.~   "
75227|NCT02072681|"~     The objective of this study is to determine the 90-day outcomes of mild and rapidly~     improving ischemic stroke.~   "
75228|NCT02072668|"~     The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce~     inflammation, coagulation and endothelial cell activation, and improve microvascular blood~     flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test~     this hypothesis, this study will evaluate the effects of rivaroxaban on:~        -  plasma markers of inflammation;~        -  plasma markers of endothelial activation;~        -  plasma markers of thrombin generation; and~        -  microvascular blood flow assessed using laser Doppler velocimetry (LDV) of~          post-occlusive reactive hyperemia (PORH).~      In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks~     each, separated by a 2-week washout phase.~   "
75229|NCT02072655|"~     In the early 2000s , professional and patient organizations are mobilizing to highlight the~     psychosocial impact of cancer disease , not only during but also after the acute phase.~      In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer~     Plan II whose objectives include :  Develop a personalized care taking into account the~     pain and psychological and social support  and  increase opportunities for patients to~     benefit from supportive care and promote the professional integration .~      This study aims to show that beyond the immediate benefits of the social aesthetic cares in~     hospital (direct soothing, improving the quality of the skin injured by chemotherapy ,~     feeling of escape ... ), these treatments can also affect quality of life for patients~     during and after hospitalization. They also may have an impact on the maintenance of social~     and / or professional satisfactory throughout the planned chemotherapy aplastic period .~   "
75230|NCT02072642|"~     Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor~     symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and~     impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these~     patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT)~     represents one such innovative therapeutic approach. Although light has an obvious to visual~     pathways within the brain, today it is known to additionally exert non-visual effects~     throughout the body. Recently our team has shown that non-visual, non-circadian light plays~     a major role in the regulation of sleep, as well as cognitive brain function in general. The~     retina, the primary conduit for the transmission of light information is weakened or thinned~     in Parkinson's patients. The dopamine system is known to enhance the processing of light~     information and intraocular injection of L-dopa in animal models of Parkinson's disease, can~     reverse associated motor symptoms. This allows for the possibility that LT would strengthen~     the dopaminergic tone in the central nervous system. However, to this date its effectiveness~     for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly~     controlled. Thus, through the convergence of basic and clinical data, a study examining the~     effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the~     effects on sleep, circadian system, mood, and cognitive functioning, is of extreme~     importance. With this information our hope is to determine if these polymorphisms allow for~     a predictive model of response to LT treatment.~   "
75231|NCT02072629|"~     This study will assess how the current VHV (VHV=CHW, community health worker) scope can be~     expanded to include iCCM and if such group interventions can provide improved access to~     treatment for children.~      In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children~     with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving~     anti-malarials?~   "
75232|NCT02072616|"~     Histological proof is a crucial and necessary step for appropriate care in oncology. In the~     case of pancreatic cancer, histological proof from pathological analysis of the surgical~     specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to~     surgical resection. In most cases, invasive endoscopic explorations are necessary for~     histological diagnosis before deciding of the most appropriate treatment (palliative~     chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration~     (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological~     diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia~     with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure~     and 92% in situations where three different procedures are required. EUS-FNA has to be~     performed by a physician properly trained for this type of interventional endoscopy. Some~     severe complications may occur but are relatively rare in expert centers (bleeding,~     perforation, complications of general anesthesia ...).~      Diagnostic alternative approach is biological with research in the peripheral blood of~     markers of tumor disease. It is possible to detect indirect markers which are molecules~     produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor~     biological material (circulating tumor cells (CTCs) or circulating tumor DNA).~      The value of detection of CTCs is not determined for the diagnostic and therapeutic~     management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of~     circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable~     forms.~   "
75238|NCT02072538|"~     New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute~     myocardial infarction (AMI). Furthermore, elevated values were associated with an increased~     risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy~     in patients with elevated admission values and kinetic changes. Other criteria for an early~     invasive strategy include a GRACE risk score >140 points or other cardiovascular risk~     factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies~     confirmed safety of early discharge protocols in patients with unstable angina (UAP). The~     aim of this study is to 1) confirm the safety of early discharge without invasive strategy~     in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore,~     patients are being randomized into 2 groups with pre-discharge and early post-discharge~     stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.~   "
75239|NCT02072525|"~     The purpose of this study is to collect serum samples for use as quality control samples in~     GSK assays. The serum samples need to include samples with low, medium and high antibody~     titers/concentrations, which cover the assay range.~   "
75240|NCT02072512|"~     The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg~     comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and~     perimenopausal HR+ advanced breast cancer.~   "
75241|NCT02072499|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating~     benign prostatic hyperplasia (BPH).~   "
75242|NCT02072486|"~     This clinical trial studies sorafenib tosylate in treating patients with liver cancer that~     cannot be removed by surgery. Sorafenib tosylate may block some of the enzymes needed for~     tumor cell growth. Blocking these enzymes may also help the immune system work better.~     Granzyme B is a biomarker that can be used to measure how well the immune system is working.~     A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a~     sign of a normal or abnormal process, or of a condition or disease. Studying granzyme B~     levels in patients receiving sorafenib tosylate may help doctors learn more about the~     effects of sorafenib tosylate on the immune system and may help to predict how well~     sorafenib tosylate will work in treating patients with liver cancer.~   "
75243|NCT02072473|"~     This proposal aims to evaluate safety and efficacy aspects of a new protocol for AVNRT~     ablation, using a stepwise anatomical approach.~      The investigators hypothesize that the use of a standardized electro-anatomical guided~     strategy, using a sequential approach as follows:~        1. Right-side postero-septal tricuspid annulus~        2. Coronary sinus~        3. Left-side postero-septal mitral annulus~      For slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful~     ablation in difficult cases, while reducing the need of re-do procedures and the risk for~     high-degree atrio-ventricular block.~      The investigators aim to define and implement a new standardized protocol for AVNRT ablation~     while at the same time assessing the efficacy and safety of coronary sinus and left-side~     approaches for slow-pathway ablation.~   "
75244|NCT02072460|"~     The present project aims at describing how vestibular signals contribute to the multisensory~     mechanisms of bodily self-consciousness.~      There is a large body of data regarding the sensory and neural mechanisms of~     self-consciousness, but most studies have so far demonstrated the contribution of visual,~     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have~     neglected the contribution of the vestibular system, a major sensory system for spatial and~     bodily representations. The vestibular system is sensitive to head motions in space and head~     inclinations with respect to gravity and it should therefore contribute significantly to~     several bodily experiences. This contribution should be put under neuroscientific scrutiny.~     We believe that the current neuroscientific models of bodily self-consciousness will be~     incomplete until they incorporate the contribution of vestibular signals.~      The present project specifically aims at testing the hypothesis according to which~     vestibular signals significantly influence bodily self-consciousness, in particular~     first-person and third-person perspective taking and the internal body models (i.e. the body~     schema and body image). The present project also aims at describing how cortical vestibular~     processing is modified during experimental changes of perspective taking and viewpoint. In~     addition, the present project will describe whether vestibular disorders change performances~     in third-person perspective taking tasks and modify internal body models. This should help~     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine~     approaches from psychophysics and electrophysiology (electromyography,~     electroencephalography) in healthy volunteers and behavioral approached in patients with~     vestibular disorders.~      These studies should further the understanding of how the brain processes vestibular~     signals, which is to date poorly understood. In addition, the outcome of the present project~     should help understanding the multiple and complex symptoms reported by patients with~     vestibular diseases, and should therefore improve their treatment.~   "
75245|NCT02072447|"~     This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral~     therapeutic- and [14C]-labeled intravenous microdoses.~   "
75246|NCT02072434|"~     The purpose of this study is to compare edoxaban (investigational drug) with warfarin and~     enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot~     complications in subjects with atrial fibrillation whose doctors plan to treat them with an~     electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from~     North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to~     receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if~     required. Participants will have an equal chance of receiving either treatment. Participants~     will be in the study for a maximum of 82 days. Study procedures will include physical~     examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram),~     finger prick blood clotting tests, blood samples, urine samples and completion of Quality of~     Life questionnaires.~      The study is expected to show that edoxaban will provide comparable incidence rates for~     efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least~     as safe as warfarin for the incidence rate for bleeding~   "
75247|NCT02072421|"~     The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess~     the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in~     patients with myocardial ischemia (other than ST-segment elevation myocardial infarction~     [STEMI]).~   "
75248|NCT02072408|"~     The purpose of this study is to evaluate the efficacy and safety of aflibercept for~     treatment of polypoidal choroidal vasculopathy without active polyp.~   "
75249|NCT02072395|"~     The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical~     procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.~   "
75250|NCT02072382|"~     The proposed study is to evaluate the possible effect of metformin on arterial pressure by~     24h-ambulatory blood pressure monitory (24h-ABPM).~   "
75251|NCT02072369|"~     The purpose of this study is to investigate the benefits of incorporating an actuated,~     EMG-controlled glove into occupational therapy of the hand.~   "
75253|NCT02072343|"~     Capnometer has been used to assess the success of intubation and the quality of~     cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions~     such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water.~     Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction~     of capnometers under the conditions of water.~   "
75254|NCT02072330|"~     The objective of this study is to compare the efficacy and safety of combined administration~     of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide~     (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.~   "
75255|NCT02072317|"~     The purpose of this study is to evaluate and compare safety and effectiveness of~     Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment~     for advanced gastric cancer~   "
75256|NCT02072304|"~     The purpose of this study is to develope web-based cognitive behavioral therapy for Korean~     adoldescents who have a mild depression. And we will investigate whether web-based cognitive~     behavioral therapy is more effective than supportive psychotherapy for treating depressed~     adolescents. Our hypothesis is web- based cognitive behavioral is more effective than~     supportive psychotherapy~   "
75257|NCT02072291|"~     The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment~     are embryo quality and the uterine ability to accept the embryo for implantation. This~     ability is influenced by uterine contractions (UC), which change in pattern and direction~     during the menstrual cycle. An abnormal uterine contraction pattern can displace the embryo~     from the proper position in the uterine cavity towards the cervix or the fallopian tubes and~     as a result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed,~     previous studies demonstrated a negative correlation between uterine contraction rate and~     implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can~     be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor~     agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists.~     The objective of this study is to evaluate the efficacy of Nifedipine administration in~     reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.~   "
75258|NCT02072278|"~     To explore a neurophysiological marker (electroencephalography) of cognitive effect of~     vortioxetine~   "
75259|NCT02072265|"~     Permanently implantable venous ports (Port-A) is very important to patients receiving~     chemotherapy. It not only provides a reliable route to administrate intravenous drugs, and~     it also requires minimal care when it is not in use. However, catheter related blood stream~     infection(CRBSI) is one of the serious complications of Port-A. The diagnosis of CRBSI~     relies on limited tools, including blood culture or symptoms and signs of active infection.~     In the stage of CRBSI, Port-A removal is necessary and pose the risk for the patients to~     re-implant the Port-A. Thus, it is crucial to early detect the infection and give~     appropriate treatment. Among the pathogens, some pathogens are related to skin contaminants.~     Before systemic spreading, these pathogens may colonize or cause minor infection~     subcutaneously. This investigation is to utilize a non-invasive dual spectrum infrared~     imaging system to evaluate the Port-A wound and to detect the infection.~      Aim: 1. To build the database of infra-red thermal images of Port-A wound healing. 2. To~     investigate the thermal images of skin contamination related CRBSI and to compare with the~     thermal images of the CRBSI of unknown foci~   "
75260|NCT02072252|"~     The purpose of this study is to determine whether a mobile phone application (app) for~     Major Depression and Generalized Anxiety Disorder is practical and acceptable to young men~     who are attracted to men, and whether it reduces their anxiety and depressive symptoms. The~     investigators will also evaluate whether reductions in symptoms are maintained over a 10~     week follow-up period after young men complete the mobile phone intervention.~   "
75261|NCT02072239|"~     The purpose of this study is to determine whether or not the Angioshield device can be~     safely applied to support saphenous vein grafts used in standard coronary bypass surgery.~   "
75262|NCT02072226|"~     PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy~     and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do~     not appear to be clearly disabling.~      Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time~     either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV~     Activase placebo and one dose of oral aspirin 325 mg.~   "
75263|NCT02072213|"~     Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male~     Volunteers~   "
75264|NCT02072200|"~     This study is multicenter, Ph IV, single arm, interventional study to assess relative~     reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication~     will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after~     2, 6 and 12 weeks after treatment (visit 2,3,4).~   "
75265|NCT02072187|"~     Low levels of vitamin D have been associated with depression. This study will test if a~     vitamin D supplement is helpful in patients with depression who have not found relief with~     the use of anti-depressant medication. Participants will continue to take their medication~     plus vitamin D or placebo for 8 weeks. The investigators will monitor their depression~     symptoms and the investigators think that the people taking vitamin D may have an~     improvement in their symptoms.~   "
75266|NCT02072174|"~     The purpose of this study is:~      • To obtain additional data on therapeutic efficacy of Anaferon for children in the~     treatment of influenza and acute respiratory viral infections in children~   "
75267|NCT02072161|"~     The purpose of this research study is to see how ETC-1002 is tolerated in the body and how~     ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin~     therapy.~   "
75280|NCT02071979|"~     This study will examine differences in the process of wound-healing in patients treated with~     platelet rich plasma (a concentration of proteins derived from a patients own blood) applied~     to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to~     patients treated with usual medical treatment . This study seeks to enroll patients who are~     18 or older with a non-healing skin wound that is at least 30 days old. Only patients with~     Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.~   "
75268|NCT02072148|"~     In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell~     Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high~     risk for long-term toxicity and mortality from therapy. While the long-term consequences of~     chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose~     radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and~     organ function and result in a significant rate of late mortality and morbidity in patients.~     Studies are now being designed to reduce the impact of RT and CRT for patients.~      Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor~     prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates~     good prognosis features will then be followed without postoperative radiotherapy. Patients~     with subsequent recurrence will be treated with either surgery and postoperative~     radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic~     features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based~     on pathology. It is expected that over 50% of patients treated with surgery will have had a~     curative treatment and will avoid radiation therapy entirely and long-term survival will not~     be changed by withholding radiation therapy to good prognosis patients after surgery. There~     are exploratory biomarkers of risk of recurrence that will be collected and studied.~      There are currently few trials examining the role of de-escalation using surgery alone in~     intermediate and early T-stage HPV related disease. New surgical techniques have broadened~     the range of patients capable of achieving a complete resection and the functional outcomes~     in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and~     radiotherapy raise the possibility that delayed or salvage treatment in early stage patients~     would be highly effective, would result in similar survival outcomes and radiotherapy could~     be applied to a much smaller population then current standards call for. Looked at from a~     different perspective, the need for post-operative radiotherapy in this younger, HPV+ and~     more functional population has not been validated in clinical trials to date.~   "
75269|NCT02072135|"~     This study involves a drug called Exparel that has been approved by the US Food and Drug~     Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting~     pain reliever. It is being given in this study to see if it provides safe and effective pain~     relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for~     as much as 72 hours after surgery.~      EXPAREL® has not been approved by the FDA for administration by popliteal block, which is~     the method the study doctors will use to give the patients the drug. Giving the drug by~     popliteal block involves inserting a small tube in to the back of the knee to deliver the~     drug. The study doctors wish to determine if patients undergoing ankle surgery and receiving~     this drug have less pain and less need for narcotic medication.~   "
75270|NCT02072122|"~     The purpose of this study is to determine the relation between estrogen and progesterone~     levels, and between dryness of the eyes, in women during their fertile years.~   "
75271|NCT02072109|"~     Early initiation of enteral feeding, achievement of full enteral feeding and cessation of~     parenteral nutrition are extremely important in the very premature infant. This way it is~     possible to achieve good post-natal growth and developement while minimizing the metabolic~     and infectious complications of parenteral feeding.~      There isn't much information in literature regarding the impact of enteral feeding on~     intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is~     also no consensus regarding the best regimen of delivering the enteral nutrition - bolus~     feeding or continuous feeding.~      The aim of our study is to compare the intestinal regional oxygenation before and after two~     feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm~     infants born before 32 weeks gestation. The evaluations will be performed using NIRS~     technology (Near Infrared Spectroscopy).~      The study may help to assess which feeding regimen is gentler to the immature intestines~     (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way~     to feed preterm infants.~   "
75272|NCT02072096|"~     The main purpose of this study is to compare the benefits and risks associated with the use~     of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM.~     One strategy is based on the use of oral and injectable medications that only reduce blood~     sugar (glucose) when it is high. The other strategy is based on non-glucose dependent~     agents. The trial will last up to 72 weeks for each participant.~   "
75273|NCT02072083|"~     The aim of this study is using intranasal dexmedetomidine versus intranasal~     midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of~     pediatric patients undergoing strabismus surgery.~   "
75274|NCT02072070|"~     The purpose of this study is to determine whether TissueGene-C, an allogeneic human~     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in~     patients with degenerative arthritis.~   "
75275|NCT02072057|"~     The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus~     kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated~     cachexia in chronic wasting diseases.~   "
75276|NCT02072044|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in~     patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.~   "
75277|NCT02072031|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to compare the efficacy and safety profile between~     Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).~   "
75278|NCT02072018|"~     Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the~     safety and efficacy of a new compound to treat this disease.~   "
75279|NCT02072005|"~     The primary aim of this study is to conduct a 9-patient feasibility and acceptability study~     of mSMART (with future studies focusing on improved medication adherence). The sample will~     include daily smokers who are already taking a prescribed medication. There will be no~     change in any medication regimen in this study, and the sample will include smokers either~     with or without a psychiatric disorder. Subjects will be asked to use a smartphone~     application, or app (i.e. mSMART) that will provide information about their medication and~     when to take it. Along with smart phone, the participants will be asked to utilize an~     electronic pillbox (i.e. GlowCap) to further assist with medication compliance.~   "
75351|NCT02071056|"~     The purpose of this study is to learn whether the DNA from cancer tumor cells can be found~     in the cerebral spinal fluid (CSF) that bathes the brain and spinal cord of patients before~     malignant the cancer cells themselves are able to be found in the CSF. The researchers doing~     this study hope this information can be used to develop a way to diagnose LM earlier .~   "
75281|NCT02071966|"~     The aim of the study is to learn more about the pathophysiology of acute coronary syndrome~     (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor.~      Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Few information is~     available about the action of ticagrelor on the molecules involved in thrombogenesis and~     platelets activation in ACS.~      The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo.~      It was observed that patients with myocardial infarction have higher blood levels of~     microparticles than patients with unstable angina or stable angina.~      The investigators assumed that ticagrelor benefits are represented by a reduction of~     microparticle levels, a marker of endothelial dysfunction in patients with cardiovascular~     disease, and by a modification in microRNAs pattern, fragments of mRNA that have a~     regulatory action in various cellular processes (such as proliferation, differentiation,~     growth and cellular death) and represent new biomarkers in ACS.~   "
75282|NCT02071953|"~     The intent of this study is to evaluate the clinical performance of an experimental dental~     bonding agent for use with dental restorative composites with and without pretreatment of~     the tooth dentin and enamel using phosphoric acid etching.~   "
75283|NCT02071940|"~     KIT (receptor tyrosine kinase) mutations occur in 15% of acral and mucosal melanomas. PIANO~     is a single arm, phase II, open-label, multicentre study to evaluate the efficacy and safety~     (plus molecular basis of such effects) of the KIT inhibitor PLX3397 (developed by Plexxikon)~     in advanced KIT mutated acral and mucosal melanoma.~      In this trial a total of 24 patients (9 in the first stage and 15 in the second stage) will~     receive treatment over a 24 month recruitment period.~      Following consent and successful screening, patients will receive PLX3397 capsules~     1000mg/day as monotherapy, and will remain on therapy as long as they are deriving clinical~     benefit. Patients will be seen every 4 weeks during treatment to monitor response and~     toxicity. Routine blood tests will be carried out at all visits and~     pharmacokinetics/pharmacodynamics sampling (1 x 8 milliliter(ml) whole blood sample) will be~     done pre-dose on Day 1 and Day 15, frozen and stored locally and sent to Plexxikon's vendor~     for central analysis at the end of the study. Imaging will be carried out every 12 weeks to~     monitor response. The first 9 patients will also receive two [18F]-fluorodeoxyglucose (FDG)~     PET scans (baseline and at Day 15).~      From specific named participating sites, 12 patients will provide additional (optional)~     consent to take part in translational research. 5 of these patients will have a fresh tumour~     biopsy taken at baseline, at day 15 and upon disease progression. The same 5 patients plus~     an additional 7 patients (to give a total of 12 patients) will also donate blood samples at~     baseline, 2 weeks, 12 weeks and on disease progression for the evaluation of circulating~     tumour cells and circulating free tumour DNA.~      All patients will be followed up every 6 months until death or for 12 months after the last~     patient has discontinued study treatment.~   "
75284|NCT02071927|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia.~      This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1~     is a dose escalation study to identify the recommended Phase 2 dose as a single agent and in~     combination with azacitidine. Patients enrolled into Part 2 will be treated with the~     recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or~     newly diagnosed AML will be treated with CB-839 in combination with azacitidine.~      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),~     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may~     predict responsiveness in later studies), and tumor response.~   "
75285|NCT02071914|"~     This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load~     from nasopharyngeal mucosa, compared to placebo.~   "
75286|NCT02071901|"~     This phase II trial studies how well eltrombopag olamine works in improving the recovery of~     platelet counts in older patients with acute myeloid leukemia undergoing induction (the~     first treatment given for a disease) chemotherapy. Platelet counts recover more slowly in~     older patients, leading to risk of complications and the delay of post-remission therapy.~     Eltrombopag olamine may cause the body to make platelets after chemotherapy.~   "
75287|NCT02071888|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced~     hematologic malignancies.~      This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological~     tumors. Patients will receive CB-839 capsules orally two or three times daily. The study~     will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended~     Phase 2 dose and will enroll patients with advanced and/or treatment-refractory~     Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM)~      In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll~     patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple~     Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for~     safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of~     glutaminase), biomarkers (biochemical markers that may predict responsiveness in later~     studies), and tumor response.~      As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be~     enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with~     relapsed or refractory disease following at least 2 prior treatment regimens will be~     enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose~     dexamethasone to further evaluate this triple combination.~   "
75288|NCT02071875|"~     To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in~     detection of moderate and severe vasospasm for detection of vasospasm in patients with~     subarachnoid hemorrhage.~   "
75312|NCT02071563|"~     This research will serve as a follow-up on the review of Title II commodities performed by~     the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso~     will test the relative effectiveness and cost effectiveness of four supplementary foods in~     the prevention of MAM and stunting in normal programmatic settings.~      The aims of this study are to:~        1. To compare the effectiveness of four alternative supplementary food commodities in~          preventing stunting and wasting, and promoting linear growth in children 6 - 23 months~          in the context of a preventive supplementary feeding program in Burkina Faso.~        2. To estimate the relative cost of implementing the supplementary feeding program using~          each commodity~        3. To estimate the relative cost/effectiveness of implementing the program using each~          commodity.~   "
75289|NCT02071862|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with solid~     tumors.~      This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid~     tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling~     patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839~     capsules orally twice or three times daily.~      In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative~     Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)~     Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase~     (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H)~     tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc~     mutation tumors.~      As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with~     standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo.~     Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel~     and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with~     everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the~     T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC~     harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with~     histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated~     with cabozantinib in combination with CB-839.~      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),~     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may~     predict responsiveness in later studies), and tumor response.~   "
75290|NCT02071849|"~     The HAART 200 Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction Trial is a~     prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of~     the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve~     annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic~     insufficiency (AI).~   "
75291|NCT02071836|"~     The overall objective of this project is to develop, evaluate, and disseminate a web~     application for first-time DWI offenders that will provide them with an age-appropriate~     brief motivational intervention (BMI) to motivate them to reduce their drinking and a~     cognitive behavioral intervention (CBI) for to help them achieve and maintain abstinence.~     The goal is to reduce heavy drinking and consequently the risk for future drunk driving.~      The specific objectives of this Phase II are:~        -  Completing the development of the Right Turns prototype based on feedback from the~          Phase I pilot study participants. This includes: providing more structure and guidance~          as participants work in the Tool Box section of the program; simplifying the content of~          the Tool Box; further R&D in the text messaging feature for 2nd and 3rd tier cellular~          providers; implement a customized pdf report function for progress reports from the~          program to users' probation officers (under control of the user); developing a~          follow-up component and outcome reports; and revising the videos in the Tool Box to~          reflect greater diversity and a younger population of drinkers.~        -  Conducting a randomized clinical trial of the program with first time DWI/DUI offenders~          who are recruited locally, collecting follow-up data, analyzing the data, and reporting~          the results.~   "
75292|NCT02071823|"~     The objectives of this study were to characterize the effects of food on the~     pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.~   "
75293|NCT02071810|"~     The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising~     dose regimens of BIA 9-1067.~   "
75294|NCT02071797|"~     The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal~     cooling system to current standard Blanketrol III cooling blanket in its ability to achieve~     therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.~      The COOLCATH study will be a prospective, open-label randomized controlled trial comparing~     induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with~     return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex~     Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH~     will be considered for this study.~   "
75295|NCT02071784|"~     The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical~     models, the potential alterations of neurovascular coupling in CADASIL.~   "
75296|NCT02071771|"~     The purpose of this study is to evaluate functional vision associated with rotational~     stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE®~     MOIST® for Astigmatism (1DAM A).~   "
75297|NCT02071758|"~     The purpose of this study is to compare the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     visceral leishmaniasis.~   "
75298|NCT02071745|"~     Total knee replacement is one of the most commonly performed orthopedic procedures. As of~     2010, about 600,000 total knee replacements were being performed annually in the United~     States and these numbers are rising. The normal knee joint functions as a complex hinge~     allowing primarily ﬂexion and extension, rotation and gliding. The knee joint is made up of~     three compartments, the lateral, medial and anterior (patellofemoral). Damage to the~     cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or~     post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis,~     tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of~     the overwhelming majority of total joint arthroplasties.~      A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the~     mechanical axis in axial and rotational planes), as well as significant pain relief which~     improves function and quality of life. Incorrect alignment can lead to abnormal wear,~     premature mechanical loosening of the components and patellofemoral problems.~      The common techniques for Total knee replacement are:~        1. Conventional method TKR~        2. CT/MRI-based preoperative navigated TKR~        3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method~          using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an~          active PC based guiding system that helps the surgeon decide on the accurate alignment~          and orientation of the implant and cutting surfaces of the bone and thus avoid~          incorrect alignment.~      We aim to compare between pre-operative and post-operative lower limb alignment (mechanical~     axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the~     existence of a correlation between the CT scans and the Orthopilot navigation system output~     and assess the clinical outcome of the patient postoperatively.~      Our Hypothesis is that the intra-operative navigation system is accurate and correlated to~     CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high~     clinical outcome,~   "
75299|NCT02071732|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) is effective in the treatment of tinnitus.~   "
75322|NCT02071433|"~     The purpose of this study is to determine whether blockade of the saphenous nerve can~     provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block~     without resulting motor blockade enhancing shortening of hospital stay en functional~     outcome.~   "
75323|NCT02071420|"~     Our objective in this pilot study is to test the combined effect of a) replacing office~     workers' sedentary workstations with active workstations (LifeBalance Station) and b)~     optimizing computer workstation ergonomics on daily occupational sedentary time,~     cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.~   "
75300|NCT02071719|"~     The rapid development of agents blocking kinases has established the use of molecularly~     targeted therapy as the preferred treatment approach for patients with metastatic renal cell~     cancer (RCC). Five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and~     pazopanib) are now approved for clinical use. Response rates differ among these agents,~     importantly depending on line of treatment. In first-line treatment sunitinib results in 47%~     objective response rates, where in second-line after cytokines 34% responds. Thus far, it is~     unclear which patient with advanced renal cell cancer will respond to targeted therapy. In~     order to select patients for targeted therapies, several profiling approaches have been~     explored but to date no adequate and reliable test is available. It is assumed that~     responses to targeted agents depend on specific receptor and protein signalling activities~     in tumor tissues. Therefore, we propose that protein phosphorylation profiling with~     phosphoproteomics may be a potential clinical diagnostic tool to predict for tumor response~     to targeted therapy.~   "
75301|NCT02071706|"~     The investigational PET/MRI scanner, including attenuation correction method, is capable of~     producing diagnostic quality images and appropriate device functionality per user feedback.~   "
75302|NCT02071693|"~     To retrospectively investigate the relationship between the Cholinergic Pathways~     Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's~     disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).~   "
75303|NCT02071680|"~     Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart~     chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The~     radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually~     identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging~     to study if we can predict baseline autonomic characteristics in patients with AF, as well~     as clinical outcome based on post ablation imaging~   "
75304|NCT02071667|"~     The purpose of this study is to see if a protein in blood, called periostin, can determine~     if patients have chronic sinusitis. This protein is in everyone's body, but the level of the~     protein may indicate certain conditions such as chronic sinusitis. The investigators are~     interested in testing levels of periostin to see if they are higher or lower than patients~     without chronic sinusitis, just as periostin is higher in patients with asthma. All patients~     enrolled in this study will have chronic sinusitis without asthma.~   "
75305|NCT02071654|"~     A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the~     treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart~     defect.~   "
75306|NCT02071641|"~     Targeted therapies are associated with (acquired) resistance after a median of 5-11 months~     of treatment, resulting in disease progression, while almost no tumors are intrinsically~     resistant in the first line setting. The investigators recently published that tumor cell~     resistance to sunitinib may be directly related to lysosomal sequestration of sunitinib.~     This resistance mechanism was shown to be transient, since a drug-free culture period could~     normalize the lysosomal storage capacity for sunitinib and resulted in recovery of drug~     sensitivity.~      In two reports it has been suggested that patients with metastatic Renal Cell Carcinoma who~     responded to sunitinib in the first-line setting may benefit from rechallenge with sunitinib~     after failure of second-line treatment. However, these data are retrospective. A prospective~     trial to investigate a rechallenge with sunitinib is needed to determine whether this~     strategy is of benefit for patients with mRCC with prior clinical benefit to sunitinib but~     who stopped treatment because of overt clinical resistance.~   "
75307|NCT02071628|"~     This study is designed for validation of in-vitro platelet aggregation assay using human~     blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for~     platelet aggregation assay, was collected from ten subjects, respectively.~      Preparation of Platelet Rich Plasma (PRP):~        1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate~          vacutainer vials.~        2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at~          room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP~          from multiple vacutainer tubes (if required) into a 15 mL conical tube.~        3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15~          minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL~          conical tube.~        4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar~          product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets~          in PRP using PPP.~      Aggregation Measurement:~      Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP~     is used as a reference to establish 100% optical transmission.~   "
75308|NCT02071615|"~     In this study the investigators compare three stimulants to each other. The effects of these~     agents on cognitive performance (eg, attention and memory) and on the brain are being~     measured. The hypothesis is that stimulants will have a positive effect on cognitive~     performance.~      Each study participant will receive once a placebo and once methylphenidate or modafinil or~     caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment~     of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults.~     Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In~     the study. These substances are given in the study only once and in the dosages in which is~     also used for the treatment of the above diseases. In the case of caffeine , the dosage~     corresponds to two cups of coffee.~   "
75309|NCT02071602|"~     The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with~     the incidence of symptomatic hypotension being one of the key safety variables.~   "
75310|NCT02071589|"~     Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a~     new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female~     volunteers.~   "
75311|NCT02071576|"~     This clinical study has been planned to evaluate the safety and effectiveness of a common~     treatment algorithms (Proscan) using 500 Hz laser repetition rate.~   "
75352|NCT02071043|"~     Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced~     disease, and only chemotherapy is recommended from the guidelines. In unresectable cases,~     neoadjuvant chemotherapy could prolong survival if conversion to resectability could be~     achieved.~   "
75313|NCT02071550|"~     In this study the investigators investigated changes in hemodynamic parameters and cerebral~     oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the~     respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied~     at the 30°head-up left side position, is compared with using two individual devices~     (INVOS-FORESIGHT).~      Methods: Afterwards the ethics committee approval of the hospital and receiving the written~     patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were~     randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the~     right side forehead region. Totally 11 evaluation periods were formed, respectively:~     Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd~     period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of~     insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th~     period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10~     cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data,~     hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.~   "
75314|NCT02071537|"~     The purpose of this research study is to test the safety of chloroquine in combination with~     carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid~     tumors.~      Also, the research study will be increasing the dose of chloroquine to find the highest dose~     of chloroquine that can be given in combination with carboplatin and gemcitabine without~     causing severe side effects.~   "
75315|NCT02071524|"~     The investigators hypothesize that large doses of fluids used during intraoperative could~     affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics.~     The purpose of this study is to evaluate fluids effects on oxygenation, respiratory~     mechanics, by using two different solutions: crystalloid or colloid.~   "
75316|NCT02071511|"~     Study hypothesis:~      With optimal medical therapy and repeated ablations, an additional renal denervation may~     have protective effects in terms of vegetative intrinsic activity and lead to a significant~     reduction in VT Burdens.~      Study design:~      Multicenter, randomized, prospective, single-blind clinical trial.~   "
75317|NCT02071498|"~     Background: Non-adherence and medication errors are common among patients with complex drug~     regimens. Applications for smartphones and tablets are known to be effective for improving~     adherence but they have not been tested in elderly patients with such complex chronic~     conditions, their older age meaning they tend to have less experience with this type of~     technology.~      Objective: to design, implement and evaluate a medication self-management application for~     elderly patients taking multiple medications called ALICE with the intention of improving~     adherence and safe medication use.~      Methods: A single-blind randomized controlled trial was conducted with a control and an~     experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified~     based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group~     with 7 professionals. ALICE was designed for Android and iOS and to allow the~     personalisation of prescriptions and medical advice, showing images of each of the~     medications (the packaging and the medication itself) together with alerts and multiple~     reminders for each alert. The randomly subjects in the control group received oral and~     written information on the safe use of their medications and the experimental group used~     ALICE for three months. Pre- and post- measures included: rate of missed doses and~     medication errors reported by patients, Morisky Medication Adherence 4 items Scale scores,~     level of independence, self-perceived health status and biochemical test results of the~     patients. In the experimental group, data were also collected on their previous experience~     with information and communication technologies, their rating of ALICE and their perception~     of the level of independence they had achieved. The inter-group intervention effects were~     calculated by univariate linear models and ANOVA, with the pre- to post-intervention~     differences as the dependent variables.~   "
75318|NCT02071485|"~     A brain-computer interface (BCI) is a system that provides a separate output pathway for~     neurological signals whereby they can be interpreted to determine the user's intended~     cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor~     cortex has allowed subjects to control virtual computer cursors in up to three dimensions by~     simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals~     are smeared by the volume conduction effect and measurement noise. The overall hypothesis of~     this study is that EEG-based virtual object control may help reveal optimal motor~     imagination tasks best used in a BCI.~      The PI's hypotheses include: (1) The use of advanced signal processing techniques will~     better reveal characteristics of EEG signals that represent the underlying motor cognitive~     function of the subject; (2) BCI systems based on SMR generated using motor imaginations~     will allow effective control of a virtual object in real time; (3) EEG imaging techniques~     will provide insight into the areas of cortical activation during a motor imagery task that~     can be utilized to increase the spatial resolution of non-invasive BCI's.~   "
75319|NCT02071472|"~     The objective is to evaluate the impact of an electronic pharmaceutical record used for~     medication reconciliation by a pharmacist associated to the anesthesiologist consultation~      Experimental intervention:~      medication reconciliation by a pharmacist using an electronic pharmaceutical record before~     the anesthesiologist consultation for planned surgery patients. The clinical pharmacist~     communicates the recommendations regarding the drug therapy to the anesthesiologist orally~     and using a specific formulary.~      Control intervention:~      Conventional anesthesiologist consultation for planned surgery patients.~   "
75320|NCT02071459|"~     Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor~     symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following~     randomization to continued therapy with droxidopa or placebo.~   "
75321|NCT02071446|"~     Deep Brain Stimulation (DBS) is an FDA approved, and widely used method for treating the~     motor symptoms of Parkinson's Disease (PD), Essential Tremor (ET) and Dystonia. Over 100,000~     patients worldwide have now been implanted with DBS devices. The DBS target regions in the~     brain are the Subthalamic nucleus (STN), the Internal Segment of Globus Pallidus (GPi), or~     the Ventral Intermediate Nucleus of the Thalamus (VIM). In order to place the DBS electrode~     in the target location, a combination of two 3D imaging techniques; 3D MRI and CT, are used.~     Data are also collected from individual nerve cells to help find the best location for the~     DBS electrode in each patient. This electrode recording takes place during the standard~     surgical implantation of the DBS electrode, and is part of the standard clinical technique.~     The investigators plan to collect additional data from populations of neurons during the DBS~     surgery in an effort to further improve the placement of the DBS electrode. These Local~     Field Potentials, LFPs, represent the activity of the collection of neurons surrounding the~     tip of the electrode, and will be measured during surgery along the path used for the~     placement of the DBS electrode. The goal of this project is to determine whether this~     additional data from surrounding neurons will help with optimal placement of the DBS~     electrode.~   "
75324|NCT02071407|"~     To explore the cerebral protective effect of midazolam in patients with traumatic brain~     injury, we will collect blood samples from patients treated with or without midazolam when~     the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of~     midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h，~     48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral~     metabolism and inflammatory response will be obtained from the blood samples or the~     cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical~     outcome and cerebral metabolism and inflammatory response will be detected with statistical~     method.~   "
75325|NCT02071394|"~     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with~     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard~     treatment for this condition. The hypothesis is that the xenon + cooling combination will~     produce better neuroprotection than the standard treatment of cooling alone.~   "
75326|NCT02071381|"~     The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in~     groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030~   "
75327|NCT02071368|"~     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in~     blood among the formulations) of the fixed dose combination (two components combined in one~     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150~     mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and~     metformin XR tablet (2 x 500 mg) in healthy fed participants.~   "
75328|NCT02071355|"~     The purpose of this study is to determine the pharmacokinetics (what the body does to a~     medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7~     days in healthy Chinese participants.~   "
75329|NCT02071342|"~     The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac~     death, myocardial infarction, target lesion revascularization (TLR), target vessel~     revascularization (TVR), thrombosis of the device in patients who are undergoing angioplasty~     in myocardial infarction and in which bioabsorbable stent was implanted (BVS). Additionally,~     we will evaluate the acute recoil after implantation of bioabsorbable stents. A 24 months~     follow-up , by means of coronary angiography accompanied by QCA and assessment with~     intracoronary ultrasound (IVUS) and VH (virtual histology) is scheduled.~   "
75330|NCT02071329|"~     The purpose of this study is to assess the safety, tolerability, efficacy, and~     immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in~     healthy volunteers following a dose of influenza A virus.~   "
75331|NCT02071316|"~     The purpose of this study is to conduct a randomized control trial, double-blind study to~     compare Hexacapron with standard of care treatment to standard of care alone to evaluate the~     efficacy of adding effect of Hexacapron to standard therapy by decreasing the episodes of~     rebleeding and mortality in patient with upper gastrointestinal bleeding.~   "
75332|NCT02071303|"~     The purpose of this study is to compare the effectiveness of Tramadol and Celecoxib in~     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in~     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 1~     hour before the procedure, the second group will receive Celecoxib 200mg 1 hour before the~     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue~     scale.~   "
75333|NCT02071290|"~     The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and~     effective intervention to prevent the development of inflammation and coagulopathy in trauma~     patients with hemorrhagic shock.~   "
75334|NCT02071277|"~     Mechanical ventilation (MV) is a cornerstone of management of acute respiratory failure, but~     MV per se can provoke ventilator-induced lung injury (VILI), especially in acute respiratory~     distress syndrome (ARDS). Lung protective ventilation strategy has been proved to prevent~     VILI by using low tidal volume of 6-8 ml/kg of ideal body weight and limiting plateau~     pressure to less than 30 cmH2O. However, heavy sedation or even paralysis are frequently~     used to ensure the protective ventilation strategy, both of which are associated with~     respiratory muscles weakness. Maintaining of spontaneous breathing may decrease the need of~     sedative drug and improve gas exchange by promoting lung recruitment.~      Pressure-targeted mode is the most frequent way of delivering after 48 hours of initiating~     MV. Three types of pressure-controlled mode are available in intubated patients: Biphasic~     Intermittent Positive Airway Pressure (BIPAP), Airway Pressure Release Ventilation (APRV),~     and Pressure-Assist Controlled Ventilation (also called BIPAPassist). They are based on~     pressure regulation but have the difference in terms of synchronization between the patient~     and the ventilator. The different working principle of these modes may result in different~     breathing pattern and consequently different in tidal volume and transpulmonary pressure,~     which may be potentially harmful. The investigators bench study with a lung model~     demonstrated higher tidal volume and transpulmonary pressure with the BIPAPassist over APRV~     despite similar pressure settings and patient's simulated effort. However, the impact of~     each mode on the delivered tidal volume and the transpulmonary pressure in spontaneously~     breathing mechanically ventilated patients is currently unknown. Their hypothesis is that~     when the investigators compare the three pressure-controlled modes, the asynchronous mode~     (APRV) will result in more protective ventilation strategy over the two other modes (BIPAP~     and BIPAPassist).~   "
75335|NCT02071264|"~     This study will implement a socio-behavioral intervention in Quezon City, the Philippines,~     using a community-based participatory approach. The intervention involves 1-2 psychosocial~     and health education training workshops for the establishment managers and their workers,~     focusing on HIV/AIDS risk reduction information and condom use and condom negotiation~     skill-building. Participants will also be invited to do dream-building activities that~     explore their personal goals and goals for their organization of peers.~   "
75336|NCT02071251|"~     Approximately 500,000 surgical site infections occur annually in the US. These lead to worse~     patient quality of life, more outpatient and emergency room visits, readmissions and home~     services, with an estimated increase in costs of at least $3500 per complication. Surgical~     site infections are associated with increasing body mass index. There is limited and~     conflicting data of the utility of multiple surgical interventions to decrease the risk of~     surgical site complications. The investigators explored the effect of a prospective care~     pathway for closure of vertical abdominal wounds on patient's wound complications.~   "
75350|NCT02071069|"~     1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab~          combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and~          fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.~        2. The relevant phase III studies reported that the progression free-survival of cetuximab~          combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.~      This study assumed that the progression free-survival was 5.1 months which was not inferior~     to the continuous chemotherapy~   "
75337|NCT02071238|"~     Understanding of an operation and its risks has been shown to give patients more realistic~     expectations, increase cooperation and result in higher satisfaction. Traditionally,~     informed consent for surgical procedures involve a discussion between the surgeon and the~     patient, but many patients easily forget the details of these talks. The investigators wish~     to investigate if providing a written pamphlet along with the standard oral discussion~     improves patients' ability to remember the details of the operation, improving the quality~     of the informed consent process.~      In addition, we will test whether a group consultation format provides a model for~     large-volume, low-variation, low-urgency surgery without reducing ability to recall risks of~     surgery or overall satisfaction.~   "
75338|NCT02071225|"~     This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine~     treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL).~     Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous~     (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6~     months, and participant follow-up will last 2 years.~   "
75339|NCT02071212|"~     The purpose of this study is to investigate the potential acute and chronic effect of~     ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of~     interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects~     with an indication for coronary angiography (CA) with or without percutaneous coronary~     intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60~     subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan~     and Procedures'). The primary objective of this study is to compare ticagrelor versus~     clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours~     after the loading dose of each regimen, in eligible subjects with CAD.~   "
75340|NCT02071199|"~     The purpose of this study is to evaluate the safety of oral topical application of~     Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis~   "
75341|NCT02071186|"~     The purpose of this study is to test the hypothesis that cognitive remediation and virtual~     reality treatment approaches can enhance cognitive and motor function in children with ADHD.~   "
75342|NCT02071173|"~     The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety,~     performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the~     RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for~     pre-market submission. Additionally, data from this study will be used to support~     post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.~   "
75343|NCT02071160|"~     The aim of this study is to examine the effect of combining melatonin to whole body cooling~     on the brain injury and outcome of neonates following perinatal asphyxia.~   "
75344|NCT02071147|"~     Purpose:~      To examine the safety of omitting the routine postoperative eye clinic review following~     phacoemulsification cataract surgery.~      Background:~      Approximately 300000 cataract extractions are performed annually in the NHS in England,~     requiring a similar number of post-operative visits, the majority of which result in no~     change in management. A conservative estimate of 70% of visits being unnecessary suggests a~     potential saving to the NHS of approximately £10M annually.~      What's involved:~      The study involves some questionnaires during the duration of the study. These include~     questionnaires relating to the quality of life of the patient (conducted before the~     operation, and at the 3 month research clinic) and a patient satisfaction questionnaire.~     There is also a research clinic 3 months following the operation.~      What are the risks/benefits:~      There are no real personal benefits to patients on the trial. The trial aims to provide very~     important information regarding the safety of discharging patients immediately after~     surgery. However the trial could potentially save many thousands of unnecessary hospital~     visits each year.~   "
75345|NCT02071134|"~     The purpose of this registry is to compile characteristics of world-wide outcomes for the~     use of Boston Scientific's commercially available Vercise DBS system in the treatment of~     Parkinson's disease.~   "
75346|NCT02071121|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this~     study population are to determine the single-dose pharmacokinetic (PK) profile and the~     absolute bioavailability (Fabs) of BIIB061 and to determine the effects of food intake~     (high-fat, high-calorie meal) on BIIB061 PK and safety.~   "
75347|NCT02071108|"~     To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects~     to demonstrate that the Shockwave device can safely and effectively deliver localized~     shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral~     arteries.~   "
75348|NCT02071095|"~     This study involves researching new approaches to treating HIV infection. Currently, HIV~     infection is treated with combinations of drugs called antiretrovirals. These drugs protect~     cells from infection by interfering with the viruses' ability to make copies of itself by~     infecting new target cells. Though these drugs are very effective, they cannot cure HIV~     infection and must be taken each and every day at prescribed doses to maintain their~     beneficial effect. This research study is investigating a new approach that involves an~     addition to existing medications.~      The study is investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an~     adjuvant. Adjuvants are medications that are designed to boost your body's immune responses~     resulting from a vaccine. The investigators want to test whether Poly-ICLC is an adjuvant~     that is effective in HIV-infected patients. A vaccine is not given in this study, but just~     investigating the adjuvant, Poly-ICLC, to determine whether it may be safe and useful in~     future vaccines that could be used to treat HIV, called therapeutic vaccines. One goal of~     future therapeutic vaccines is to reduce the virus that remains persistently inside of cells~     in a dormant or resting state despite treatment with HIV medications. This persistent pool~     is termed the latent virus pool or viral reservoir. One tactic to reduce this viral~     reservoir is to first stimulate HIV to start replicating in order to force it out of hiding.~     Once viral replication occurs, the infected cells may then be recognized and killed by cells~     of the immune system. Therefore, we also want to see what effect Poly-ICLC has on the virus~     that lives inside of cells. Specifically, the investigators want to look at whether~     Poly-ICLC increases the level of virus inside your cells while also improving your immune~     system's responses.~      The investigators are doing this research in hope to find new ways to treat HIV infection~     that may reduce exposure to medications that are called antiretrovirals. Antiretrovirals are~     medications used to treat HIV infection. They are very effective but have side effects and~     have to be taken each and every day and cannot cure HIV.~   "
75349|NCT02071082|"~     This study will assess the efficacy, safety, and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected~     adults.~      Participants will be enrolled into two cohorts:~        -  Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive~        -  Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed~   "
75415|NCT02070211|"~     The purpose of the present trial is to investigate the effects of omega-3 PUFAs in~     individuals aged 12-26 years with 22q11DS at ultra-high risk for developing a first episode~     of psychosis.~   "
75353|NCT02071030|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam~     Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third~     molars in reducing patient's morbidity. Adults having a close relationship between the~     mandibular canal and one or both lower third molars, as diagnosed from digital panoramic~     radiographs will be recruited for this randomised controlled trial. In one trial arm,~     patients will receive the standard digital panoramic radiograph prior to third molar~     surgery. In the second arm, subjects will undergo an additional Cone Beam Computed~     Tomography (CBCT) prior to third molar surgery.~      All patients require a postoperative visit one week after surgery to assess the outcome.~   "
75354|NCT02071017|"~     Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high~     grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last~     half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can~     provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging~     (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the~     simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially~     presented with brain tumors, and predict the prognosis in the patients diagnosed with~     primary high graded astrocytoma or oligodendroglioma.~   "
75355|NCT02071004|"~     This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in~     healthy male and female subjects. It is hypothesized that co-administering DS-1040b with~     aspirin at steady state will be safe and well tolerated by healthy male and female subjects.~   "
75356|NCT02070991|"~     Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of~     subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left~     ventricular dysfunction.~   "
75357|NCT02070978|"~     This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II~     core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of~     atacicept in subjects with systemic lupus erythematosus (SLE). The Week 24 visit of ADDRESS~     II core trial will coincide with the Day 1 visit of this LTE trial.~   "
75358|NCT02070965|"~     The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA~     (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily~     for 15 days.~   "
75359|NCT02070952|"~     The purpose of this study is to determine the side effects and how effective CyberKnife~     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The~     CyberKnife system is a new type of radiation machine that uses a special system to precisely~     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses~     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will~     be minimal. The purpose of this evaluation is to see if this treatment will help patients~     with low to intermediate risk prostate cancer and to evaluate the effect of this treatment~     on the patients' quality of life over time.~   "
75360|NCT02070939|"~     This single and multiple ascending dose study is the first evaluation of PF-0626414, a~     Selective Androgen Receptor Modulator in humans. The goal is to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male~     subjects .~   "
75361|NCT02070926|"~     The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic~     patients with type 2 diabetes mellitus) registry is a large, prospective observational~     registry of demographic, clinical and laboratory data with long-term clinical outcome of~     asymptomatic diabetic patients without history of CAD or angina or angina-equivalent~     symptoms at two affiliated hospitals of The Catholic University of Korea.~   "
75362|NCT02070913|"~     A single-center, prospective case series clinical study consecutively enrolling up to 10~     patients with expected duration of 12 months or less. The study objectives are to evaluate~     retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM~     System.~   "
75363|NCT02070900|"~     The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and~     will compare the impact of the provision Point of Care CD4 technology and early knowledge of~     CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring~     package. Option B+ will be implemented at all sites and 16 intervention sites will receive~     POC CD4 machines and visits from a team of clinical mentors.~      The study also aims to assess rates of ART initiation and time to ART initiation of HIV~     positive pregnant women in settings implementing option B+ with or without POC CD4 and~     related counselling/support; rates of retention in care of HIV positive mothers at 6 months~     post ART initiation in settings implementing option B+ with or without POC CD4 and related~     counselling/support; rates of ART initiation and retention at 6 and 12 months post ART~     initiation according to different levels of CD4 count; cost of retaining HIV positive~     pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct~     to good clinical care of HIV positive pregnant women.~   "
75364|NCT02070887|"~     The overall aim of this observational study is to investigate the impact of COMT inhibition~     on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD~     patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering~     to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or~     computer-based.~   "
75365|NCT02070874|"~     Patients in isolated rural settings often lack easy access to pain care and specialist~     services. Yet rural residents are more likely than their urban counterparts to be older; be~     in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be~     uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health~     care delivery that has been found useful and effective in many clinical settings and~     specialties. Telehealth technologies can bridge geographic distance and increase access to~     specialist care in rural settings. We propose a cluster randomized clinical trial design to~     test the effects of a telehealth-enhanced palliative care pain-management program for 288~     patients and 96 providers in rural health care settings. The proposed program will provide~     services to both patients and providers: Patients will conduct self-assessments and report~     pain and other symptoms via telehealth. Health care providers will receive~     telehealth-delivered case consultations that will include case management, evidence-based~     practice resources, and peer support. Providers and their patients will be randomly assigned~     to intervention groups, which receive the telehealth-enhanced palliative care~     pain-management intervention, or to control groups. Our primary aim is to compare patient~     self-reports of pain and quality of life in the intervention and control groups over 2~     months. Aim 2 is to examine, in the intervention and control groups over 2 months,~     providers' knowledge and attitudes regarding pain and perceived competence in treating pain.~     Aim 3 is to evaluate the cost-effectiveness of the telehealth intervention. We will use~     mixed effects models with patients nested within providers to evaluate the effect of the~     intervention on study outcomes. Findings from this study will be instrumental in advancing~     telehealth and improving pain management and palliative care among underserved rural~     populations.~   "
75366|NCT02070861|"~     The investigators hypothesize that exhaled CO2 reflect changes in blood circulation due to~     changes in lung circulation, provided CO2-production in the tissues and ventilation from the~     lungs are stable. The investigators want to investigate this in patients using different~     devices: a finger cuff measuring blood pressure and cardiac output (the amount of blood~     being pumped out of the heart each minute), an esophagus ultra sound device measuring~     cardiac output, and exhaled carbondioxide in the patients` breath measured by the~     ventilator.~      The investigators investigate patients undergoing bypass surgery on the heart, as they~     undergo relevant changes in blood circulation during their operation.~   "
75367|NCT02070848|"~     Physical exercise triggers various physiological responses including a marked increase in~     muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood~     flow is controlled is currently unclear.~      The primary purpose of this study is to establish the respective contribution of metabolic~     (linked to energy requirements) and mechanical (linked to muscle tensions) signals in the~     exercise hyperemia and the possible role of the red blood cells.~      Vasodilation and muscle blood flow during exercise are controlled by ATP released in the~     plasma from the red blood cells in response to a combination of metabolic and mechanical~     signals applied on the vasculature.~   "
75368|NCT02070835|"~     Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in~     clinical practice. This study was conducted to have a prospective, randomised, controlled~     study compare the safety and efficacy of the ReCell® technology with skin graft (experiment~     group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot~     ulcers.~   "
75369|NCT02070822|"~     This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to~     evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will~     be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the~     tumor responses. After day 28, all subjects will receive standard clinical care and be~     follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate~     with patients' outcome. The investigators hypothesis that it might be helpful to combine~     DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients'~     prognosis.~   "
75370|NCT02070809|"~     A wound comprises a break in epithelial continuity and disruption of structure and function~     of underlying tissues, the treating and repairing is always a great challenge in clinical~     practice. The complex healing process make the wound easy to get a tendency of nonhealing~     and result in a heavy burden of life quality. Nowadays surgical repairing is still the main~     method, but there was still no effective and satisfy outcomes. Because none of the~     treatments could repair skin both on structure and function. Now the investigators provide a~     quick and effective method to rebuilt complete structure and function of the skin based on~     tissue-engineered skin technology. To further test the efficacy and safety of this new~     method, the investigators propose a prospective randomized controlled multicenter trial to~     compare this method with traditional skin graft.~   "
75371|NCT02070796|"~     The primary objective of the study is to establish Bioequivalence (BE) of 2 different~     formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.~   "
75372|NCT02070783|"~     Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant~     properties. However, EPO may cause serious side-effects with repeated administration~     (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that~     does not have the effects of EPO on blood cells but may still have its effect on brain~     function. In an attempt to replicate previous findings with (a single dose of) EPO in~     healthy volunteers, we study the effects of ARA290 on the cognitive and neural processing of~     emotions in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a~     positive shift in information processing compared to placebo, 7 days post-administration.~   "
75373|NCT02070770|"~     The purpose of this study is to determine whether short-term adherence to a very low calorie~     diet is effective in improving heart rate variability in obese individuals.~   "
75374|NCT02070757|"~     This is a phase 3, multicenter, prospective, randomized study of intravenous (IV)~     ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either~     ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial~     pneumonia (HABP).~   "
75375|NCT02070744|"~     The objective of this study is to evaluate the safety and efficacy of VX-661in combination~     with ivacaftor in subjects with cystic fibrosis (CF) who are homozygous for F508del CFTR~     (cystic fibrosis transmembrane conductance regulator) mutation~   "
75376|NCT02070731|"~     A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter~     aortic valve implantation.~   "
75377|NCT02070718|"~     Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs)~     may affect thermoregulation. This pilot study has the aim to establish proof of concept~     regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot~     flashes.~   "
75378|NCT02070705|"~     This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic~     resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a~     procedure that takes detailed pictures of functional and structural properties inside the~     body using magnetic field and radio frequency pulses. These pictures may help identify~     underlying malignancy in patients at high risk or active malignancy in patients who have~     undergone chemotherapy for pancreatic cancer.~   "
75379|NCT02070692|"~     The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal~     bleeding in women who are using the Etonogestrel contraceptive implant.~   "
75380|NCT02070679|"~     The purpose of this study is to evaluate the effect of vitamin E on preventing from~     incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone~     coronary angiography.~   "
75381|NCT02070666|"~     The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury~     Prediction Score), under mechanical ventilation could benefit from a protective ventilatory~     strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This~     would lead to a decrease in incidence, mortality and health care costs associated to this~     syndrome.~      This study will help to confirm the current evidence about low tidal volumes, evaluating~     adverse events of this strategy.~   "
75382|NCT02070653|"~     Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause~     of death in Europe and North America. A key limitation of contemporary treatment strategies~     of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an~     effective treatment for large AAA, it is associated with significant mortality and morbidity~     as well as substantial cost. The rationale for this randomized controlled study is to~     investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic~     aneurysms.~   "
75383|NCT02070640|"~     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to~     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).~     We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction~     during cholecystectomy.~   "
75384|NCT02070627|"~     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to~     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal)~     in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness~     of NIRF-C in identifying the cystic duct junction during cholecystectomy.~   "
75385|NCT02070614|"~     This study was designed for exploring the association of cytochrome P450 3A4 rs2242480~     polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal~     surgery，to provide evidence for genetic prediction of personalized medication.Methods:60~     patients who prepared for elective upper abdominal surgery under general anesthesia were~     recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480~     genotyping was carried out by direct sequencing. The blood samples were drawn before~     anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil~     concentration detection with high performance liquid chromatography-mass spectrometry~     (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil~     immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue~     analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil~     concentration and PCA sufentanil consumption were analyzed to investigate the differences~     among rs2242480 three genotypes.~   "
75386|NCT02070588|"~     This feasibility study is being conducted to determine potential associations between a~     broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and~     clinical findings involved in mild traumatic brain injury (mTBI).~      These associations will be examined over the acute and sub-acute period (approximately 3~     months) following injury to provide information useful for optimization of MR pulse~     sequences for mTBI applications.~      Correlations exist over the sub-acute period in clinical neurological and MR data (images,~     image reads, and RAW data), which may indicate temporal evolution patterns. The intent of~     this study is to broadly generate potential biomarkers of temporal evolution of mTBI~     detectable in MR images and data (MR mTBI biomarkers).~   "
75387|NCT02070575|"~     The purpose of this study is to investigate if a new blood test looking at PSA and a group~     of PSA related proteins in a patient's blood can indicate which men after surgery with a~     rising PSA could benefit from treatment, and/or indicate which men are at higher risk for~     recurrence before initial treatment is given.~   "
75388|NCT02070562|"~     This study aims to investigate breast milk composition and dietary habits of Chinese~     lactating mothers. Further understanding of the composition of human milk will help to~     understand the nutritional needs of mothers and their infants in their early phase of life~     which eventually will help to support breastfeeding.~   "
75389|NCT02070549|"~     This phase I trial studies the side effects and best dose of trametinib in treating patients~     with cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib~     may stop the growth of tumor cells by blocking proteins needed for cell growth. When these~     proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will~     then die. Hepatic dysfunction is frequently found in patients with advanced cancer and~     usually prevents patients from receiving standard treatments or from participating in~     clinical trials. Patients may also need dose adjustments or absorb drugs differently.~     Trametinib may be a better treatment for patients with advanced cancers and hepatic~     dysfunction.~   "
75390|NCT02070536|"~     Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have~     limited positive predictive value. No studies have evaluated predictive kinetics of plasma~     biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad~     population of critically ill patients or as an adjunct to clinical prediction scores.~      The main objective of the investigators study is to evaluate the predictive values of plasma~     soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to~     the intensive care unit (ICU).~      One of the investigators goals is to improve early identification of patients at risk for~     ARDS in order to better implement preventive stategies prior to ARDS development.~      The primary outcome is the occurrence of ARDS during the first week after admission to the~     ICU.~   "
75391|NCT02070523|"~     To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD)~     inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with~     VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether~     chemotherapy containing PLD with a higher response rates and greater safety in adult ALL~   "
75392|NCT02070510|"~     This trial is conducted in Europe. The aim of the trial is to investigate the influence of~     oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in~     healthy subjects.~   "
75393|NCT02070497|"~     The study is to investigate the effectiveness of nursing case management for lung cancer~     patients in a Taiwan medical center.~   "
75394|NCT02070484|"~     The purpose of this study is to compare the effect and safety of NuCel to DBX on patients~     undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.~   "
75395|NCT02070471|"~     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126~     immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI~     (ST-segment Elevation Myocardial Infarction)~   "
75639|NCT02067286|"~     The objective of this study is to evaluate the clinical sensitivity and specificity of the~     Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat~     Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a~     nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.~   "
75396|NCT02070458|"~     This phase I trial studies the side effects and best dose of ixazomib when given in~     combination with mitoxantrone hydrochloride, etoposide, and intermediate-dose cytarabine in~     treating patients with acute myeloid leukemia that is unresponsive to initial induction~     chemotherapy or recurs following an initial complete remission. Acute myeloid leukemia is a~     cancer of the bone marrow cells; bone marrow is where blood cells are normally made.~     Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, and~     intermediate-dose cytarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Mitoxantrone hydrochloride,~     etoposide, and intermediate-dose cytarabine are standard treatment for relapsed or~     refractory acute myeloid leukemia. Giving ixazomib with mitoxantrone hydrochloride,~     etoposide, and intermediate-dose cytarabine may improve the effectiveness of the~     chemotherapy.~   "
75397|NCT02070445|"~     During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood~     to be directed away from the heart and the lungs and pumped through the body while the heart~     is not beating. Surgery on the heart easier when it is not beating and bloodless area.~     Generally during CPB the lungs do not need to be ventilated, as no blood is flowing through~     the lungs and the body received oxygen from a machine (oxygenator) attached to the CPB pump.~      In this study we are investigating the difference in lung collapse after heart surgery in~     patient who did have their lungs ventilated during CPB, compared to patients who did not~     have their lungs ventilated during CPB. We will use lung ultrasound scans to determine the~     degree of lung collapse at various time periods before and after the heart surgery. We will~     also investigate if ventilation during CPB will affect: a.) the rate of lung infection or~     pneumonia after the operation b.) the time it takes for a patient to have the breathing tube~     removed in the intensive care unit after the operation c.) the time for a patient to be~     discharged home from the hospital d.) the concentration of oxygen in the blood after the~     operation.~   "
75398|NCT02070432|"~     This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11~     following photodynamic therapy (PDT) of patients with advanced head and neck cancer.~   "
75399|NCT02070419|"~     This randomized phase II trial studies how well transarterial chemoembolization (TACE) works~     compared with TACE plus radiation therapy in treating patients with end stage liver disease,~     liver tumors, or potential liver transplant candidates. TACE involves reaching up to the~     blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the~     physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor~     and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and~     stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is~     a type of radiation therapy that delivers radiation to the tumor cells but does not harm~     normal liver cells. It is not yet known whether TACE is more effective with or without SBRT~     in treating liver tumors.~   "
75400|NCT02070406|"~     This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T~     cells and vaccine therapy when treating patients with advanced cancer that has spread to~     other areas of the body and has not responded to standard therapies. This trial also will~     determine the best dose of Ipilimumab to use in this combination treatment. T cells are a~     special type of white blood cell (immune cell) that have the ability to kill cancer cells. T~     cells are taken from the blood and modified in the laboratory to recognize a specific~     protein expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and~     kill cancer cells that express that protein. Dendritic cells are another type of blood cell~     that can teach other cells in the body to look for cancer cells and attack them. Giving a~     dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune~     system to target cancer cells expressing that protein, and further help the T cells attack~     cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory~     that is similar to antibodies made in the human body that fight off infection. Ipilimumab~     blocks a protein that turns down the immune system, so blocking this protein may make the~     immune system more active. This may increase the ability of immune cells to kill cancer~     cells and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells,~     a dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize~     and kill cancer cells that have the NY-ESO-1 protein.~   "
75401|NCT02070393|"~     The purpose of this study is to drastically reduce unnecessary breast dose in young females~     with Hodgkin's Disease who require radiation therapy.~   "
75402|NCT02070380|"~     This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg~     and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of~     MultiHance.~   "
75403|NCT02070367|"~     This pilot study will test a new therapy, somatosensory rehabilitation, for the painful~     sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome~     (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's~     evaluation of their own symptoms and the impact of these symptoms on their daily activities~     will also be tested to make sure they are consistent and accurate.~      Previous research has suggested one of the assessments may also be used to assist in the~     identification of CRPS: this simple test will be evaluated to see if it can accurately~     identify persons with this disorder (for which there is currently no diagnostic test).~     Together, this will improve treatment of CRPS through early, accurate diagnosis and the~     ability to measure important changes in this painful condition, and set up future studies~     for this new rehabilitation treatment method.~   "
75404|NCT02070354|"~     The purpose of this research study is to determine how bariatric surgery affects physical~     activity and nutrient intake.~      This research study is being done because the investigators want to determine better~     recommendations to provide to bariatric surgery patients.~   "
75435|NCT02069938|"~     Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual~     and physical objects through the voluntary modulation of brain rhythms. Current issues with~     noninvasive BCIs include exhausting motor imagery tasks and long training times required to~     achieve competent control. The investigators will address these issues within this protocol,~     examining new approaches to reduce the effort required by subjects to control a physical~     object in the task.~      The PI's hypothesis is: Control of a physical robotic device will increase the performance~     of subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with~     a physical output.~   "
75405|NCT02070341|"~     Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon~     cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation~     administration is now recognized as an important component for achieving superior cleansing.~     Multiple randomized controlled trials and meta-analyses have found split-dosing to be~     superior than day-before dosing. Objective: This study aims to compare two types of bowel~     preparations in split-doses to assess for differences in patient tolerability, as well as~     efficacy of colon cleansing. Methods: This is a prospective, single-blinded,~     randomized-controlled trial. Patients who are being referred for a colonoscopy will be~     recruited to participate in the study. They will be randomly assigned to receive either a~     split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient~     tolerability will be examined through questionnaires. The endoscopist performing the~     colonoscopy will use two standardized bowel preparation scoring systems to evaluate the~     quality of the cleansing. The investigators propose that P/MC will be superior to PEG in~     patient tolerability and non-inferior in bowel cleansing effects.~   "
75406|NCT02070328|"~     Proton therapy is a limited medical resource that is more expensive than conventional x-ray~     therapy. To correctly measure the success of proton therapy in treating different~     conditions, it is important to check a patient's health status after their treatment is~     finished. Checking on the progress of patients over many years (called long-term follow-up)~     is needed because the long-term effects of proton therapy are not well known.~   "
75407|NCT02070315|"~     Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM~     Elastography may provide a non-invasive, fast, and reproducible alternative for the~     quantitative assessment of liver fibrosis.~   "
75408|NCT02070302|"~     This study will be a prospective double blind controlled randomized trial of ten patients~     diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of~     medical practices in Arizona. Patients who meet inclusion criteria will be randomly~     distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal~     Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned~     individuals.~   "
75409|NCT02070289|"~     The purpose of this study is to investigate safety, toleration and time course of plasma~     concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two~     age groups, 18-55 years (Group 1) and 56-75 years (Group 2).~   "
75410|NCT02070276|"~     Spinal anesthesia is still the regional anesthesia technique most widely employed in~     everyday clinical practice.~      The most feared and common of its well known side effects consist in an abrupt reduction of~     systemic vascular resistances, with consequence risk of systemic hypotension. To prevent~     this potentially severe complication, an adequate correction of patients' volume status~     through a preventive administration of fluids is widely used.~      However this volume repletion is commonly accomplished on an empirical basis, without having~     a real insight of patient hemodynamic status, carrying the risk of possible volume overload.~      Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide~     volemic repletion before spinal anesthesia on the reduction of significant hypotension rate,~     compared to empirical fluid administration.~   "
75411|NCT02070263|"~     The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected~     tree nuts and to examine potential predictors of oral tolerance and 2) to determine the~     usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut~     allergy and oral tolerance.~   "
75412|NCT02070250|"~     Psychological interventions for cancer patients have been tested and found to reduce stress~     and improve quality of life. These interventions have been tested at academic medical~     centers but have not been available for use by community mental health professionals. One~     such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L.~     Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators~     to train mental health professionals from across the country to deliver the BBI at their~     institution. Recently diagnosed cancer patients who are participating in the BBI group at~     these institutions may participate in a research study completing self report measures~     asking about psychological and behavioral outcomes (for example, mood, stress, diet and~     physical activity). The investigators hypothesize that individuals participating in the~     intervention will report improvements in outcomes, such as reduced stress and improved mood,~     reduced symptoms of the disease and treatment, etc., after completing the intervention and~     continue to report these improvements up to 6 months after the group ends. OSU will~     coordinate this data collection project but information about participating sites is listed~     in http://clinicaltrials.gov.~   "
75413|NCT02070237|"~     Pregnant and recently postpartum women are at significantly higher risk of developing a~     blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot~     in their lungs known as a pulmonary embolism (PE) compared to their non pregnant~     counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in~     pregnant versus non-pregnant women and further increases almost 11 fold in the post partum~     period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011,~     the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines~     stating that for patients undergoing cesarean delivery with additional risk factors for clot~     or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin~     (LMWH) a type of blood thinner should be considered. However, no specific guidelines about~     which risk factors should be considered, or what medication doses should be used were~     provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice~     Guidelines published in 2012 delineated who should be given prophylaxis based on various~     risk factors, however acknowledged that the recommendations were based on weak quality~     evidence.~      ACOG endorses either once or twice a day dosing for high risk patients after delivery and~     states that adjustments for obese women should be made on a case by case basis. However,~     there are limited studies on the dosing of LMWH in specific subpopulations including post~     operative patients, pregnant patients and obese patients. All of these studies have urged~     further investigation of the correct dosing for these high risk subjects due to changes~     associated with pregnancy and the level of medication in the blood that may put these~     patients at higher risk of venous thromboembolism. Many previous studies have shown that~     women in these high risk categories do not achieve protective levels of the medication~     measured with a laboratory test; anti Xa level. The investigators hypothesize that due to~     their dual risk, obese post-operative recently pregnant women may not be adequately~     protected with the daily fixed dose and might need more frequent dosing to protect them.~      The objective of this study is to assess what proportion of women achieve the desired anti~     Xa level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).~   "
75414|NCT02070224|"~     The purposes of this study are to assess the prognostic value of serum and urinary~     biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the~     progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee~     osteoarthritis clinical score at 12 months. Additionally, this study will search for~     correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with~     the radiographic, MRI and clinical severity of knee osteoarthritis.~   "
75416|NCT02070198|"~     Despite the progression in assisted reproductive technology (ART), poor ovarian response to~     controlled ovarian stimulation remains a challenge for clinicians and a source of distress~     for patients. Multiple strategies have been tried to overcome these obstacles. The increase~     of the gonadotropin administration have been associated with a very low pregnancy rate. The~     introduction of GnRH agonist protocol, which takes advantage of the initial rise in~     endogenous gonadotropins that follows the agonist administration in the early follicular~     phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have~     improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were~     introduced in ART treatment. They are effective in preventing a premature LH surge and allow~     for a more natural recruitment of follicles in the follicular phase in a non suppressed~     ovary. However, the randomized studies comparing the efficacy of these two regimens reported~     conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH~     such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal~     testosterone failed to improve IVF outcomes. Recently, the new treatment option with~     corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary~     to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems~     to have a potential beneficial effect in poor responders.~      The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH~     antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .~   "
75417|NCT02070185|"~     The main objective is to study, in 8-11 year old children, the influence of energy density~     conditioning on liking for new flavored beverages and on caloric adjustment after the~     beverage consumption. The stability of the energy conditioning was evaluated after a period~     without exposure and after an extinction period during which the energy density of the~     beverages was changed.~   "
75418|NCT02070172|"~     Motion limitations have been previously reported in people with headaches originating from~     the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been~     found useful to diagnose this type of headache. This observational study investigates this~     neck motion test when performed actively by the patient and passively by the examiner, then~     compares the results of motion attained.~   "
75419|NCT02070159|"~     Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent~     platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested~     especially in East Asian ethnicities. The investigators compared the effect of lower loading~     dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.~   "
75420|NCT02070146|"~     Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent,~     lymph node involvement and the presence of distant metastases. However, there remains great~     inter-patient variability regarding treatment outcome. A combination of biochemical factors,~     histopathological features, genomic profile, environmental factors and other clinical~     factors are likely to influence prognosis and treatment effect, independent from tumor~     stage, but it is still unclear which, how, and to what extent these factors can influence~     tumor recurrence and mortality in both early stage (I-III) and late stage (IV) CRC.~      Although the results from prospective clinical trials will remain the backbone of evidence~     based medicine, this concerns a highly selected patient population since the large majority~     (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It~     is unlikely that trial participation will significantly improve in the near future. This~     fact has the following implications: 1) It is highly desirable to validate the results from~     trials in the general patient population. However, this is complicated by the fact that the~     documentation of patients treated in general practice (i.e. outside the scope of clinical~     trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic~     characteristics and treatment parameters. 2) There is an increased availability of novel~     technologies that provide molecular markers with potential prognostic and/or predictive~     value. To test the clinical value of these markers large numbers of patients are required~     which greatly exceeds the number of patients who consent to participate in prospective~     clinical trials. 3) as a result of rapid technical developments, a range of new minimally~     invasive treatment options for CRC are entering the market. These interventions have the~     potential to be of great benefit for patients in terms of improved local control, higher~     probability of complete tumor removal, less damage to surrounding tissue, faster recovery~     and less short and long term side effects. Still, the interventions will have to prove their~     effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on~     a patient level. A prospective observational cohort study has the great opportunity to fill~     this gap.~   "
75421|NCT02070133|"~     To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the~     efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation;~     (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance)~     index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1),~     double-blind, placebo control study. Population: 18 males with stable COPD between 40-80~     years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and~     80% predicted post-bronchodilation.~   "
75422|NCT02070120|"~     Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of~     frequent low grade recurrence, which usually necessitates surgical intervention under~     general anaesthetic. This multicentre study aims to establish the short term efficacy of~     chemoresection using chemotherapy within the bladder for the treatment of NMIBC.~      Should the levels of complete response following chemoresection meet predefined criteria, a~     larger phase III trial would be developed to assess longer term disease related endpoints,~     with the aim of standardising management of recurrent low risk NMIBC and potentially~     removing the need for over a thousand patients each year to undergo surgery.~   "
75423|NCT02070107|"~     No more than 56% of subjects at the Robley Rex Louisville Veterans Administration Medical~     Center (VAMC) prescribed boceprevir-based triple therapy, will complete Hepatitis C (HCV)~     treatment as prescribed. Of patients who did not complete therapy, the primary reasons for~     discontinuation were side effects (48%) and non-adherence (32%). An intervention is needed~     to improve the treatment completion rate in subjects so they can achieve the high SVR rates~     noted in SPRINT-2 and RESPOND-2~   "
75424|NCT02070081|"~     The overall aim is to study the multiple factors determining the variation of weight loss~     after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.~      The specific aims are to evaluate:~      a) what explains the large individual differences in weight loss seen after RYGB and Sleeve~     surgery, b) if it is possible pre-operatively to identify which patients will not obtain~     beneficial effects of bariatric surgery in relation to weight loss and quality of life and~     c) if patients in need of improved care can be identified pre- and/or early~     post-operatively.~   "
75640|NCT02067273|"~     The purpose of this pilot study is to test the durability of response to Transcranial~     Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The~     investigators will test various methods of TMS for varying lengths of time in a pilot study~     to investigate what the clinical impact.~   "
75425|NCT02070068|"~     Operations on the liver, bile ducts, and gallbladders are some of the most commonly~     performed abdominal operations in the United States. Cholecystectomy, removal of the~     gallbladder, is the most common of these with more than 750,000 performed annually. Injury~     to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1%~     to 0.5%), but it is an important source of patient morbidity. Serious injuries often require~     at least one surgical repair, and these repairs have variable long-term outcomes. Techniques~     to allow the visualization of the bile ducts may prevent such an injury, by providing vital~     information about the presence of gallstones in the CBD and show a surgical road map of the~     ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography~     of not exposing patients and healthcare providers to radiation. This technique also allows~     the superimposition of the cholangiogram onto the normal image.~      This study is being conducted to optimize an imaging technique called PINPOINT. Images will~     be obtained during clinically necessary operations. The images will be evaluated to~     determine the best method for locating and outlining the anatomy. The information learned~     will guide the future use of PINPOINT in laparoscopic procedures.~   "
75426|NCT02070055|"~     There is a large variability in people's ability to burn fat during exercise. It is thought~     that differences in dietary intake can partly explain this variation, however this has not~     been comprehensively studied. This will be investigated by measuring participant's habitual~     diet and rates of fat oxidation during exercise, and look for associations between the two.~   "
75427|NCT02070042|"~     We aim to evaluate whether the addition of Omega-3 fatty acids to oxybutynin, a standard~     first-line treatment for overactive bladder syndrome, will improve symptoms and quality of~     life. Secondarily, we will evaluate whether Omega-3 fatty acids help reduce the adverse~     effects of oxybutynin.~      Hypothesis~        -  Primary: Omega-3 will enhance the beneficial role of oxybutynin in the treatment of~          overactive bladder (OAB)~        -  Secondary: Omega-3 will reduce the side effects of dry eyes and constipation associated~          with oxybutynin~   "
75428|NCT02070029|"~     Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and~     Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized~     treatment for this condition. We know that alternative therapies such as acupuncture have~     been beneficial to women suffering from urinary incontinence, chronic lower back pain, and~     migraines. We hypothesize that the quality of life for premenopausal women with hypoactive~     sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a~     duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and~     1 week after the final acupuncture session as the method of analyzing our primary outcome.~   "
75429|NCT02070016|"~     The purpose of this study is to test whether non-invasive brain stimulation, such as~     Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic~     pain conditions. We will test various methods of TMS to identify a treatment approach that~     may reduce the symptoms of chronic pain for the patient.~   "
75430|NCT02070003|"~     The investigators aim to characterize the relationship between changes in emotional~     distress, opioid use, and pain throughout surgery and recovery. Additionally, the~     investigators aim to compare the effectiveness of post-surgical motivational interviewing~     and physician-guided opioid weaning vs. usual care on reducing persistent opioid use.~     Overall, the proposed research will advance knowledge regarding the role of psychological~     factors contributing to persistent opioid use after surgery.~   "
75431|NCT02069990|"~     Circa-annual variations in 25-hydroxyvitamin D [25(OH)D] levels have been well established,~     and there also seems to be an effect of season on bone turnover and bone mass. been shown~     that bone turnover follows a circa-annual rhythm. On the basis of human clinical results, it~     was suggested that adipose tissue functions as a vitamin D buffering system that to a~     certain extent prevents uncontrolled synthesis of 25(OH)D in the liver. Directly related to~     this issue is the question of how much vitamin D is needed to ensure target serum~     25-hydroxyvitamin D [25(OH)D] concentrations. According to the recommended dietary~     allowances, persons should achieve levels of intake of essential nutrients considered to be~     adequate to meet the known nutritional needs of practically all healthy persons Moreover it~     is important to note that the significant percentage of the population is temporarily of~     continuously deficient in vitamin D. In the similar condition of vitamin D deficiency, the~     aetiology is very different since only as almost exclusively as a consequence of a primary~     disease in children it is manifested: hypovitaminosis D is highly prevalent among children~     on renal substitution therapy, regardless of the type of therapy used and the stage of renal~     failure.~      The rationale providing high dose strengths of vitamin D based on an assumption of better~     compliance especially in adult with senior age patients; also a potential for faster~     resolution of vitamin D deficiency, since utilization of cholecalciferol is higher when~     patients had low levels of 25(OH)D, and vice versa, there is a plateau phase when close to~     normal range (Vieth 2001).~      According to clinical data, a doses equivalent of daily 1000 IU, (7000 IU per week, or 30000~     IU per month) is considered as a minimal effective dose to treat vitamin D deficiency. The~     treatment of vitamin D with a duration of 30 days may result and increase of 6-12.5 nmol/L.~     With the deficiency criteria considered as <20 ng/ml, the vitamin supplementation is~     indicative, the treatment dosages should be adjusted to the increase planned to achieve the~     mid-normal range.~      As the base of calculations, the doses of 40 IU results in an increase of 0.4 ng/ml in a~     period of 60 days. Accordingly 1000 IU in a period of 2-5 month resulted in an increase of~     approx 10 ng/ml. The risk of overdose in relatively low, since the absorption and the~     metabolic path is well controlled: automatic mechanisms downregulation at normal ranges.~      In this study the there are three groups in the similar daily dose equivalent of 1000~     IU/day. The absorption of daily , weekly and monthly dosing should have a buffered effect~     due to the body adipose tissues, balancing the daily 1,25(OH)D levels, and moreover to~     provide a biological reservoir. The three doses are considered as comparable in efficacy and~     safety.~      The fourth group is intended to utilize the expanded dose range of 4286 IU/ day, using the~     30.000 IU tablets on a weekly dosing schedule. This group is to demonstrate the efficacy of~     higher doses to normalize the vitamin D levels, within a reasonable timeframe of 60-90 days.~   "
75432|NCT02069977|"~     -  To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral~          problems in Asian children and adolescents with a diagnosis of autism spectrum~          disorder, as measured by change from baseline to endpoint on the irritability subscale~          of the aberrant behavior checklist (ABC-I).~        -  To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the~          treatment of serious behavioral problems in Asian children and adolescents with a~          diagnosis of autism spectrum disorder.~   "
75433|NCT02069964|"~     Some patients with head and neck cancer or benign tumours of the head and neck receive~     radiotherapy to their neck as part of their treatment. The large arteries in the neck, the~     carotid arteries, are often included in the area being treated with radiotherapy. There is~     some evidence to show that radiotherapy to these blood vessels can result in thickening and~     furring of the artery walls some years after treatment. This thickening may then result in~     stiffening and narrowing of the artery.~      Current research is now aimed towards detecting radiotherapy-related changes to the carotid~     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating~     these blood vessels if possible. The question of whether or not the use of preventive~     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is~     currently unanswered.~      The aim of this study is to compare the thickness (intima-medial thickness) of the carotid~     artery wall over time (a period of 5 years) following radiotherapy to the thickness in~     carotid arteries that have not received radiotherapy. There are many other causes for~     thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes)~     and these may affect the ability to measure the effect of radiotherapy change to the artery~     wall. In order to address this, it is ideal to look at this process in patients who are~     having only one side of the neck treated and use the other side as a comparison. The study~     will also be investigating for earlier signs of radiotherapy-related changes, such as~     stiffening of the artery wall, inflammation in the artery wall (a very early sign of~     radiotherapy-related change) and some markers in the blood that may indicate that this~     process is taking place.~      The null hypotheses of this study are:~        -  In irradiated carotid arteries, mean intimal-medial thickness at one year following~          radiotherapy will be the same as in unirradiated arteries.~        -  The incidence of carotid artery stenosis will be the same in irradiated and~          unirradiated carotid arteries~        -  Arterial wall strain at one year following radiotherapy will be the same in irradiated~          and unirradiated carotid arteries.~        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries~          during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will~          not demonstrate at what dose of radiotherapy inflammation begins.~        -  Serum biomarker levels will not increase over time from baseline after radiotherapy and~          won't correlate to IMT and arterial strain.~   "
75434|NCT02069951|"~     Surgical training programs using virtual reality simulators often only use basic skills~     training and the use of procedural training is very limited. Procedural training differs~     from basic skills training by requiring integration of isolated skills and decision making~     and planning components. However, it is unknown if it is necessary to practice all~     procedures before operating on actual patients or whether it is simply a matter of learning~     psychomotor skills and if these skills are transferable between different tasks.~      The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it~     easier to reach proficiency on a different laparoscopic procedure on the simulator because~     participants have already practiced the integration of isolated skills.~   "
75463|NCT02069574|"~     The purpose of the present study is to identify the novel periodontal disease biomarkers~     using differentially expressed microRNA in the saliva. The severity of chronic periodontal~     diseases and the time of pre- and post-treatment are major classification criteria. The~     obtained data will secure the foundation for the development of a new non-invasive~     diagnostic methods for early diagnosis & prognosis prediction of periodontal disease.~   "
75436|NCT02069925|"~     The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian~     approach (TIPS) to early detection substantially reduce the duration of untreated psychosis~     (DUP) and improve outcomes beyond an established first-episode service (FES)?~      The primary aim of this study is:~        1. To determine whether an early detection intervention can reduce DUP in the US, as~          compared to usual detection. Early detection (ED) will be implemented in one US~          community (New Haven, CT), and usual detection efforts will continue in another~          (Boston, MA). DUP will be measured at admission to the corresponding first-episode~          services (STEP & PREP) in each community, over one year before and throughout ED~          implementation. The investigators hypothesize that DUP will be reduced significantly in~          the early detection site compared to the usual detection site;~        2. A secondary aim is to determine whether DUP reduction can augment the outcomes of~          established FES on outcomes in the U.S. The investigators will measure symptoms,~          functioning and engagement with treatment at entry and over 1 year at each site. The~          investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced~          distress and illness severity at entry and better early outcomes at STEP compared to~          PREP.~   "
75437|NCT02069912|"~     1. Implement an evidence-based structured care approach that includes screening; acute~          treatment and relapse prevention follow-up tailored for public sector clinics and~          low-income and minority patients.~        2. Adapt an evidence-based collaborative care model for primary care, implement the~          adapted model, evaluate and further refine the model based on the pilot experience, and~          produce and disseminate a detailed manual for use in public sector clinics.~        3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to~          determine: its acceptance by patients, medical providers, and organizational~          decision-makers; patient depression treatment adherence; its direct cost; and the size~          and variability of change from baseline in the primary outcome measures: depressive~          symptoms, functional status, quality of life, health service use, and cardiac status at~          6 and 12 month follow-up.~   "
75438|NCT02069899|"~     International, multicenter, long-term, follow-up study that will enroll HLH patients who~     have received NI-0501 in a previous clinical trial, in the context of the clinical~     development program for NI-0501~   "
75439|NCT02069886|"~     The CENTAurus trial is a prospective clinical study designed to address systematically some~     of the relevant endocrine complications in an iron overloaded thalassemic population,~     primary objective being the assessment of the effect of deferasirox therapy on glucose~     metabolism/homeostasis. Other endocrine parameters complementary or supportive to the~     primary objective will be assessed and analyzed during this study. A number of lab~     parameters related to other axes of the endocrine system will be collected and analyzed.~   "
75440|NCT02069873|"~     The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of~     evidence-based therapies in comparison to a wait-list control and evaluate the relative~     contribution of exposure, cognitive, and skills blocks of treatment in a 16-session~     manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1:~     Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and~     Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD~     symptoms than the skills component. Significant results will establish the efficacy of a~     group format for evidence-based treatments for all veterans with a PTSD diagnosis. An~     ancillary part of the study is to examine initial neuropsychological presentation in this~     population and possible changes that may occur as the result of treatment.~   "
75441|NCT02069860|"~     A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear,~     connected with a double lumen central venous catheter inserted in the jugular vein, and will~     be used in conjunction with an adapter as a permanent vascular access for hemodialysis~     treatment.~   "
75442|NCT02069847|"~     Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and~     early esophageal cancers. However, esophagectomy is associated with significant morbidity~     and mortality. With the advance of therapeutic endoscopy, there has been a growing interest~     and application of endoscopic resection and mucosal ablative techniques for the treatment of~     these diseases. Esophageal stricture (ES) formation has become an increasingly recognized~     complication of extensive endoscopic mucosal ablation and/or resection. The resultant~     symptomatic stricture development can significantly impair a patient's quality of life.~     Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid~     injection is invasive, costly, and associated with the potential risk of perforation.~     Recently, oral corticosteroids have been introduced for the prevention of esophageal~     stricture after endoscopic submucosal dissection.~      Budesonide is a synthetic steroid with topical anti-inflammatory properties and high~     first-pass metabolism; thus, potentially less systemic absorption and side effects.~      Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who~     underwent radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection~     (ESD) for advanced premalignant esophageal lesions or superficial esophageal cancers.~   "
75443|NCT02069834|"~     The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine~     vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout~     24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under~     conventional HAART (2 NNRTI + 3rd agent).~      The main secondary objectives are the following:~        -  % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48~        -  % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48~        -  % of virological failure defined by two consecutive plasma viral load > 50 copies/mL~        -  Profile of genotypic resistance in case of virological failure.~      The trial will be conducted according to the design below, in 3 steps:~        -  Step 1: enrollment of 80 patients (40 in each arm)~        -  Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the~          intervention arm have been analyzed.~        -  Step 3: resumption and completion of enrollment if conditions for resuming enrollment~          at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to~          the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is~          significantly > 70%, which translates in a maximum of 6 virologic failures.~   "
75444|NCT02069821|"~     The purpose of the study is to assess the pharmacokinetic interactions between amlodipine~     besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.~   "
75445|NCT02069808|"~     Disprove the null hypothesis as follows:~      Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH~     medication per treatment protocol outlined below, use of adjunctive LH activity medication~     Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as~     from egg donors not treated with Menopur™.~      Objectives:~      Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity~     medication Menopur ™ for our volunteer egg bank donors.~      Efficacy defined as:~        1. #Days of ovarian stimulation to GnRH agonist trigger.~        2. Peak serum estradiol level on day of GnRH agonist trigger.~        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.~        4. Number of mature oocytes recovered and cryopreserved.~      Study type: Randomized prospective clinical trial.~      Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA~     and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle~     count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.~      Study design:~      Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and~     adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.~      Random number generator with patients assigned basd on odd or even numbers.~      Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible~     cycle cancellation for poor ovarian response or patient elective withdrawal to result in at~     least 20 subjects in each group completing the study.~      Primary measure of outcome: number of mature oocytes recovered and cryopreserved.~      Secondary measures of outcome:~        1. #Days of ovarian stimulation to GnRH agonist trigger.~        2. Peak serum estradiol level on day of GnRH agonist trigger.~        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.~   "
75446|NCT02069795|"~     The waveform assessment of an athlete's speech production has a high probability of showing~     abnormalities after brain injury (concussions) which could be used not only for diagnosis of~     the concussion, but for recovery of the brain. The aim of this study is to investigate this~     possibility using the Cobweb automated application system for acoustic processing.~   "
75447|NCT02069782|"~     MIHOPE is a multi-state study of home visiting programs authorized under the Maternal,~     Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the~     federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV~     program. It is being conducted by MDRC under contract to the Administration for Children and~     Families within the US Department of Health and Human Services. In conducting the research,~     MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns~     Hopkins University, Columbia University, University of Georgia, and James Bell Associates.~      MIHOPE is seeking to randomly assign about 4300 families nationally to home visiting~     services or to a comparison group that will receive referrals to other services in the~     community. The study is seeking to include 88 local home visiting programs (sites) that are~     funded through MIECHV in approximately 12 states. In Washington, the study plans to randomly~     assign approximately 360 families across 6 home visiting program sites. Data will be~     collected from families, local home visiting programs, and state and federal administrative~     data systems to assess the effects of the programs on family outcomes and to learn more~     about how the programs are run. Sites included in the evaluation will be using one of four~     national service models (Nurse Family Partnership, Healthy Families America, Parents as~     Teachers, and Early Head Start—Home Visiting Option) that states have chosen for most of~     their MIECHV funding. MIHOPE will inform the federal government about the effectiveness of~     the MIECHV program in its first few years of operation, and it will provide information to~     help states develop and strengthen home visiting programs in the future. Research findings~     will be disseminated through a report to Congress in 2015; reports on program impacts,~     implementation, and on the relationship between program features and program impacts;~     journal articles; and practitioner briefs.~   "
75448|NCT02069769|"~     The goal of this study is to determine if scheduled communication with the oncology team~     through phone calls is helpful to caregivers with the transition to hospice care.~   "
75449|NCT02069756|"~     DuchenneConnect is an online, patient-report registry for individuals with Duchenne and~     Becker muscular dystrophy and carrier females. The purpose of DuchenneConnect is to connect~     Duchenne and Becker patients with actively recruiting clinical trials and research studies,~     and to educate patients and families about Duchenne and Becker care and research. At the~     same time, DuchenneConnect is a valuable resource for clinicians and researchers in academia~     and industry, allowing access to a de-identified, aggregate dataset provided by patients and~     their families—information that is vital to advances in the care and treatment of Duchenne.~     DuchenneConnect is a member of PCORnet, the National Patient-Centered Clinical Research~     Network.~   "
75450|NCT02069743|"~     The investigators have developed a mobile application (for use on smart phones) to help~     cancer patients better manage cancer pain. This study is a randomized controlled trial to~     evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that~     subjects randomized to the intervention group will achieve greater reductions in~     cancer-related pain and improved quality of life.~   "
75451|NCT02069730|"~     This is a study of select drug therapies in patients with salivary gland cancer. The study~     has two phases: a molecular profiling phase (phase 1) and a treatment phase (phase 2).~      In molecular profiling phase of the study, participants will provide a sample of their tumor~     tissue to test for changes in certain genes that show whether certain drug treatments will~     be more useful than others.~      Once participants have undergone molecular profiling, they will be offered a drug treatment~     depending on the results. Certain drug treatments are designed to target certain gene~     changes. If there is a matching drug treatment, participants will be offered that treatment~     (either outside a clinical trial or within a clinical trial). If there are no gene changes~     or there are changes to genes were there are no drug treatments available for those certain~     changes, participants will be offered the study drug, Selinexor.~      Cancer is the uncontrolled growth of cells. Research shows that one way cancer cells can~     grow uncontrollably is when certain proteins, called exporter proteins, are present in high~     levels in the body. These proteins prevent certain other proteins important in protecting~     cells from becoming cancerous and important in the controlling the growth of cells, from~     working. The study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear~     Export (SINE) that blocks the exporter proteins from working which may allow the other~     proteins to work and slow or stop tumors from growing.~   "
75452|NCT02069717|"~     The purpose of this study was to assess the incidence rate of the major adverse~     cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin~     therapy in patients who have history of acute myocardial infarction and are diagnosed with~     metabolic syndrome.~   "
75453|NCT02069704|"~     This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab~     biosimilar) and Avastin® with 2 parallel arms to compare the PK profile of BEVZ92 and~     Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy.~      FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital~     standard of care.~   "
75464|NCT02069561|"~     The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to~     colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic~     Acid treatment might be associated with changes of the gut microbiota and metabolomic~     profiles in patients with long-standing ulcerative colitis.~   "
75641|NCT02067260|"~     The overall purpose of this clinical investigation is to collect data to support a marketing~     application for over the counter use of the X5 HairLaser with an indication for hair growth.~     The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can~     safely and effectively perform self-use application by following written instructions.~   "
75454|NCT02069691|"~     Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking~     and balancing ability. Many studies point out that cycling is an effective means for lower~     limb rehabilitation. However, during training, the unaffected limb may compensate for the~     affected one resulting in suboptimal rehabilitation. To address this issue, the~     investigators developed the virtual reality-cycling training system (VRCTS) which can~     acquire force and speed signals in real-time through a cycling module. The system then~     analyzes the acquired data and uses a 3D VR rehabilitation program to help patients to train~     their affected side. The aim of the study was to develop the VRCTS, verify its function and~     test system function on both normal subjects and stroke patients.~      Methods: In this system, the investigators designed a cycling device that is embedded with~     load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling~     Graph User Interface Control and Data Recode System (Cycling CR System) was applied for~     signal analysis and feedback control. The investigators designed a 3D interactive VR~     rehabilitation program that can guide and train the users through visual feedback. Each user~     performed a pre-test to examine determine condition, left-right balance and other~     parameters, which allows the system to be customized.~   "
75455|NCT02069678|"~     This will be a multi-center study in Hong Kong. This is a retrospective-prospective study in~     HBeAg-negative chronic hepatitis B patients. HBeAg-negative patients on entecavir followed~     up in the liver clinics will be identified from the existing database. All patients had HBV~     DNA testing every 6 months as a clinic routine. Serum HBsAg levels will be tested in the~     residual serum samples at the pre-treatment and last follow-up visits. Eligible patients~     will be discussed on the plan of stopping entecavir therapy. All patients will have written~     informed consent before recruited into this study. All patients will be followed up for 12~     months after stopping entecavir treatment. As entecavir is most commonly used antiviral drug~     in Hong Kong and in the Western countries, the investigators aim to investigate and validate~     the use of serum HBsAg quantification to guide the timing of stopping entecavir in~     HBeAg-negative patients. The results of this study will provide scientific evidence on the~     use of this new serum marker to predict sustained remission after stopping entecavir. In the~     long-run, it can improve patient compliance, reduce the need of long-term antiviral and~     reduce the drug cost in the management of HBeAg-negative chronic hepatitis B.~      All patients will stop entecavir according to the Asian Pacific guideline with written~     informed consent and close subsequent monitoring. In the protocol, there is a safety net for~     re-treatment. There will not be any invasive procedure. There is no major ethical issue.~   "
75456|NCT02069665|"~     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine~     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.~   "
75457|NCT02069652|"~     The data of Taiwan CDC showed the total HIV victims amounted up to 22,020 from 1984 to 2011.~     Under risk factor analysis, it indicated the increasing victims among MSM (men having sex~     with men, including homosexuals & bisexuals) cohorts, from 64% of them in 2009 to 72% in~     2011. For age stratification of patients, the youth (from 15 to 24 years old) comprised of~     18.5% (4078). Among them, 40% are students. MSM are still the main population (over 80%)~     from 2009 to 2011. Therefore it is crucial to target the young MSM.~   "
75458|NCT02069639|"~     Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival~     after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of~     treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have~     a dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by~     Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing~     whether TARC levels after alloSCT were correlated to disease status and whether TARC~     monitoring could increase the ability to predict relapse.~   "
75459|NCT02069626|"~     Bleeding from the staple line is a complication of linear stapling. After clamping, a short~     period after firing of the laparoscopic linear stapler is recommended. That is, the~     clinician should continue to press the tissue between the prongs of the device to achieve~     adequate hemostasis at the staple line. The significance of the waiting period for~     hemostasis at the staple line has not been empirically clarified in humans. In this study,~     the investigators compared the number of bleeding points use of the laparoscopic linear~     stapler. Consequently, the investigators assessed the effects of time after the firing of~     linear stapling in patients who underwent laparoscopic gastric bypass.~   "
75460|NCT02069613|"~     The objective of the study is to determine the relative roles for various testing modalities~     in the diagnosis and prognosis of mild traumatic brain injury.~   "
75461|NCT02069600|"~     Rationale: Almost all the information the investigators have about the effect of continuous~     positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from~     randomized clinical trials including only middle-aged patients. Little is know, however,~     about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP~     treatment in elderly patients with severe OSA on clinical, quality-of-life and~     neurocognitive spheres. Methods and Measurements: Open-label, randomized, multicenter~     clinical trial of parallel groups with blinded end-point design conducted in 12 Spanish~     teaching hospitals on a consecutive clinical cohort of elderly (≥ 70 years) patients with~     confirmed severe OSA (IAH≥ 30) receiving CPAP or no therapy while maintaining their usual~     control for three months. CPAP titration was performed by an auto CPAP device. A good~     adherence was set as at least 4 hours/day of CPAP use. Primary endpoint was the measurement~     of quality of life by the Quebec Sleep questionnaire, which includes diurnal and nocturnal~     symptoms, hypersomnolence, and social and emotional dimensions. Secondary endpoints include~     different sleep-related symptoms, presence of anxiety or depression, office blood pressure~     figures and some neurocognitive tests. Patients were invited to a clinical visit on three~     occasions to quantify the adherence to CPAP. Intention-to-treat analysis was performed.~   "
75462|NCT02069587|"~     Preterm premature rupture of membrane is associated with increased oxidative stress and~     inflammatory process, enhancing the activity or the availability of antioxidants may~     modulate the inflammatory response associated with PPROM, thereby reducing oxidative stress~     and the risk to the fetus. In this study the investigators sought to determine the effects~     of Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation~     associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients~     (fetal )Ph and apger scores~   "
75465|NCT02069548|"~     This study addresses postures and range of motion in cervical dystonia (Spasmodic~     Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to~     increase the understanding of the biomechanics of the movement disorders of the cervical~     column in this pathology. In addition, the clinical state of cervical dystonia of the~     patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale~     (TWSTRS). The investigators will compare the results between control and study groups.~   "
75466|NCT02069535|"~     This trial is an open, national, multi-centre trial. The main objective of this trial is to~     assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement~     of related Adverse Events.~   "
75467|NCT02069522|"~     This is a prospective, double blind, crossover study in healthy infants randomized to one of~     two study formulas. The trial will consist of two 21 day study feeding periods separated by~     a study washout period.~   "
75468|NCT02069509|"~     This is a multi-centre, multi-national, prospective, observational study of Friedreich's~     Ataxia (FRDA) with a control group to:~        -  obtain natural history data on individuals affected by FRDA~        -  relate clinical assessments and results from proteomic analyses~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of FRDA which may also be potential outcome measures for~          use in future clinical trials and clinical care~        -  plan for future research studies~   "
75469|NCT02069496|"~     This post-marketing surveillance study is designed to collect safety information such as~     post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1)~     Intramuscular Injection.~      The following items will be investigated as priority investigation items. <Priority~     investigation items>~        1. Allergic reactions~        2. Anaphylaxis~   "
75470|NCT02069483|"~     Smokers who are not actively engaged in quitting will participate in a study using~     self-generated text and audio text messages containing reasons to quit smoking.~   "
75471|NCT02069470|"~     Background Denmark has a lower survival of cancer compared to most European countries. Fast~     track pathways for organ specific cancers were established in the years 2008-2010. In 2011~     further a fast track pathway for non-specific serious symptoms. Cancer in general practice~     is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer~     patients per year. The investigators know that cancer patients have an increased use of~     general practice prior to diagnosis and that 25% of them wait for more than 20 days in~     general practice for referral according to the GPs. The latest Danish Cancer Plan therefore~     includes a CME as a key strategy to lower the GP threshold to refer patients to cancer fast~     track pathways.~      The aim of this study was to investigate the effect of this CME in early cancer diagnosis.~     This is measured by changes in GP knowledge, attitude and risk assessment. GP referral~     behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit~     rate, cancer patients´ tumor stage at treatment and 1 year survival.~      Methods/Design The study is conducted as a stepped wedge controlled design based on a~     quasi-cluster randomization.~      In august 2012 an invitation to participate in the present study were sent to 859 general~     Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient~     they referred to a fast-track diagnostic pathway for cancer within an 8-month period.~      Every other week, we received data from a regional database. We reminded the referring~     GP-practice about non included patients. The collected data will be linked to registries.~      The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available~     evidence from the literature following the investigators ensured a multifaceted interactive~     teaching method including case-based education. The content included by other topics~     positive predictive values, false reassurance from negative testing and other pit-false.~      Statistical analyses The outcomes will be analyzed in a generalized linear random-effects~     model with random effect of GPs. Based on data it will be assessed whether further modeling~     of inter correlation within practices and within clusters is required, and whether the~     intervention effects are assumed equal for all GPs, or in random interaction with them.~     Analyses will be performed both in the full GP-population (intention to intervening ) and~     in the 3 subgroups of GPs.~   "
75472|NCT02069457|"~     Several studies have confirmed that patients with cirrhosis possess an imbalance in~     procoagulant versus anticoagulant activity due to increased factor VIII and decreased~     protein C. Moreover, in the last two decades there has been an increased recognition that~     not only bleeding but also thrombosis complicates the clinical course of cirrhosis. The~     prevalence and pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis~     without hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess~     the prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular~     carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these~     patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The~     patients are going to follow up for one year and evaluate at baseline and every 6 months by~     liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical~     events will be evaluated at every follow up.~   "
75473|NCT02069444|"~     For endotracheal entubation in children mostly Miller and Macintosh blades have been used.~     On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without~     having a direct sight of the airway and without having to align oral, pharyngeal, and~     tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and~     Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and~     intubation quality score.~   "
75474|NCT02069431|"~     The life expectancy of older Americans continues to increase, with persons aged > 65 years~     representing the fastest growing segment of the US population (Manton et al., 1995). While~     prolongation of life remains an important public health goal, a goal of even greater~     significance is that extended life should involve preservation of the capacity to live~     independently and to function well physically, cognitively, and socioemotionally (Katz et~     al., 1983). Therefore, identification of proven interventions to maintaining functioning~     across these domains and prevent disability is a major public health challenge (Branch et~     al., 1991). Greater physical and cognitive independence in older adults has been shown to~     crucially influence social integration in old age (Cornwell & Waite, 2009), resulting in~     significant increase in quality of life and reduction of risk for morbidity and mortality,~     social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A~     promising candidate to promote functional levels across physical, cognitive, and~     socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et~     al., 2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012).~     Combining neuroendocrine with behavioral approaches (e.g., performance-based measures of~     physical and cognitive function), the proposed multidisciplinary research therefore sets out~     to clarify the extent to which intranasal administration of OT over a period of 4 weeks can~     reduce inflammation and improve physical and cognitive function in older men. Constituting a~     complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this~     project will also allow examination of interactions between OT's effect on physical health,~     cognition, and socioemotional function.~   "
75475|NCT02069418|"~     In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances~     have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine~     kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as~     erlotinib.~      This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST~     criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.~      Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and~     18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has~     identified early responding patients and with better progression-free survival in erlotinib~     first line and in the second or third line.~      To date, none medico-economic study has been conducted to determine if this strategy will be~     cost-effective.~      The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and~     18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib~     (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to~     the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8~     of erlotinib treatment.~      A health economics ancillary study will be achieved. Indeed, recent therapeutic~     improvements, in particular targeted therapies in NSCLC, have improved quality of life and~     life expectancy, but have also induce an important increase of the health costs. According~     to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during~     the 10 last years. More efficient strategies that would permit to stop early with objective~     endpoints, expensive therapies is a main achievement in thoracic oncology.~      The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders~     and replace another treatment before a deterioration in their physical status, 2) reduce the~     risk of side effects and costs of unnecessary treatment and 3) to propose a customization~     treatment after the first line therapy.~   "
75476|NCT02069405|"~     To acquire low radiation dose and good quality cardiac CT images requires scanning at low~     heart rates which is usually done with beta-blockers. However, in some patients~     beta-blockers have little effect. This is thought to be due to a different mechanism of~     action which continues to maintain the heart rate despite administration of beta-blockers.~     This study aims to look at the effect of music or relaxation tracks to reduce patient heart~     rate as anxiety is thought to play a role in maintaining high heart rates. This study will~     randomise patients into a normal standard of care group compared to a normal standard of~     care group with music/ relaxation track and compare heart rate, radiation dose, image~     quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety~     Inventory (STAI) questionnaire.~   "
75477|NCT02069392|"~     Schizophrenia is marked by problems in attention, memory and problem solving. These deficits~     predict long-term functional outcome such as the ability to live independently and maintain~     employment, but they are not ameliorated by currently available medications. Cognitive~     training improves these functions to some degree, but this approach is time- and~     resource-intensive. The current project aims at enhancing and accelerating the benefits that~     people with schizophrenia derive from cognitive training by administering nicotine during~     some of the training sessions. This would provide the proof of principle for a type of~     treatment intervention to improve cognitive symptoms of schizophrenia.~      The current project aims at determining whether the intermittent presence of nicotine during~     cognitive training exercises in people with schizophrenia will shorten the training period~     necessary to induce significant and clinically relevant improvement and enhance the~     improvement seen after a training period of specified length.~      Hypothesis 1a: Nicotine administration during training will increase the size of all~     measured effects of the training intervention, and will accelerate the time course of~     performance enhancement on the MCCB and training exercise progression parameters.~      Hypothesis 1b: The larger training effects in the Nicotine Group will persist beyond the end~     of the intervention.~      Hypothesis 2a: Within-session progress on the training exercises will be larger in the~     presence of nicotine than in the presence of placebo.~      Hypothesis 2b: These acute nicotine-induced performance elevations will persist beyond the~     presence of nicotine through subsequent non-drug training sessions, giving evidence of an~     acute facilitation of learning processes.~   "
75478|NCT02069379|"~     Insulin resistance, a primary component of the metabolic syndrome, is an escalating~     phenomenon in the United States, and confers an increased risk of depression and mood~     disorder, particularly in women. The relationship between metabolic and mood disorders may~     be mediated by endogenous opioid activity in limbic brain regions. We propose to examine~     affective state and μ- opioid system function in insulin resistant women, and change in~     response to insulin sensitizing treatment, through the following specific aims and~     hypotheses:~      Establish relationship between insulin resistance, affective state, and μ-opioid receptor~     function.~        1. Insulin resistant women will have greater μ-opioid receptor availability at baseline,~          and a larger response to stress challenge than non-insulin resistant women~        2. Insulin resistant women will have greater negative affective state at baseline, and a~          greater emotional response to stress challenge than non-insulin resistant women.~        3. Mediational analyses will reveal that the relationship between insulin resistance and~          negative affect is mediated by μ-opioid receptor function and neural activation in the~          amygdala and nucleus accumbens affect-regulating regions.~      Examine effects of insulin regulation on μ-opioid receptor function and affective state.~        1. Improved insulin sensitivity will be accompanied by decreased μ-opioid receptor~          availability at baseline and a reduced response to stress challenge. Degree of change~          in baseline receptor availability and response to stress challenge after treatment will~          correlate with degree of insulin regulation.~        2. Improved insulin sensitivity will be associated with improved affective state at~          baseline, and with a reduced emotional response to stress challenge. Degree of change~          in affective state and emotional response to stress challenge after treatment will~          correlate with degree of insulin regulation.~        3. Mediational analyses will reveal that the change in affective state after insulin~          regulation is mediated by change in μ-opioid receptor function and neural activation in~          the amygdala and nucleus accumbens.~      The expected results would suggest a role for the endogenous μ-opioid system in mediating~     the relationship between metabolic function and emotional processes.~   "
75479|NCT02069366|"~     The goal of this study is to look at how a type of drug called cannabinoids are related to~     the processing of fear signals, the experience of emotions and fear, and the pattern of~     activity in the brain that is involved in these processes and how this relates to the~     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that~     occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of~     the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the~     person of the event, difficulty experiencing emotions, loss of interest in activities the~     person used to enjoy, and increased arousal, such as difficulty falling asleep or staying~     asleep, anger and hypervigilance. The information gained from this study could lead to the~     development of new treatments for persons who suffer from anxiety or fear-based disorders.~   "
75480|NCT02069353|"~     Cardiac arrest is the most common cause of death in the United States and as many as 590,000~     Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to~     89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain~     injury is the most common cause of death and disability after cardiac arrest. The~     investigators use advanced brain monitoring in patients who are at high risk of death after~     cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem~     the investigators have observed is low oxygen levels in the brain, which is often very~     difficult to treat.~      In this study, the investigators plan to use two additional brain monitors in the care of~     these high risk patients: a monitor for seizures and a monitor of the amount of blood flow~     in the brain. The investigators will use these to detect and treat potential causes of low~     brain oxygen levels. The main hypotheses are that electrical events in the brain such as~     seizures and spreading depolarizations will occur during times of low brain tissue oxygen~     level, and that treating these events and low blood flow will reduce the rate of low brain~     oxygen levels.~   "
75481|NCT02069340|"~     This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related~     osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid~     is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these~     drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the~     jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is~     more likely to get BRONJ and why.~   "
75482|NCT02069327|"~     This is an observational study designed to investigate the role of fat emboli in patients~     who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose~     of this study is to obtain samples of bone marrow and blood during tibial or femoral~     fracture procedures to understand the inflammatory response.~   "
75483|NCT02069314|"~     This research study was conducted to investigate the effects of a high protein diet on the~     efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was~     that a high intake of dietary protein would result in a less efficient use of energy in~     skeletal muscle in older adults.~   "
75484|NCT02069301|"~     The study evaluates LIFE-DM, an integrated microfinance and collaborative care intervention~     by comparing it to enhanced treatment as usual (national guideline antidepressant care and~     referral to microfinance resources) in Vietnam. Intervention effects at baseline, 6 month,~     and 12 month follow-up on patient outcomes, including depression, anxiety, quality of life,~     functioning, self-efficacy, satisfaction, and income will be compared across the two~     conditions.~   "
75485|NCT02069288|"~     Septic shock (associated with relative adrenal insufficiency) is characterized by decreased~     arterial responsiveness to catecholamines. The association of hydrocortisone and~     fludrocortisone has demonstrated an improvement in survival in septic shock patients. If~     hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone~     remains to be elucidated. The purpose of our study is to investigate the effect of a~     physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure~     dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients~     with septic shock.~   "
75486|NCT02069275|"~     The purpose of this study is to investigate the frequency of bleeding and haematomas in~     patients undergoing coronary angiography or percutaneous coronary intervention via femoral~     artery and mobilized immediately after the procedure, compared to those mobilized after two~     hours (following the standard regimen). At the same time the investigators will investigate~     whether it reduces the discomfort being mobilized immediately after the procedure.~   "
75487|NCT02069262|"~     There were many approaches for patients with obscure gastrointestinal bleeding (OGIB).~     Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy,~     laparoscopy, computed tomography and angiography have been recommended as investigation.~     However, of these techniques, the evaluation and management of patients with OGIB remains a~     formidable challenge. We compared the diagnostic yield and long-term outcomes of patients~     with OGIB randomized to angiogram combination laparoscopy or angiogram alone.~   "
75488|NCT02069249|"~     The proposed study has the following aims: (a) to assess the concomitant and longitudinal~     links between sleep and cognitive, behavioral and emotional functioning in kindergarten~     children; (b) to assess the immediate and the long-term effects of an intervention to~     promote healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on~     related cognitive, behavioral and health domains; (c) to assess the immediate and the~     long-term effects of an intervention deigned to promote healthy nutrition (HNI) on the~     eating habits of children, their weight and BMI measures (the comparison/control group) and~     (d) to assess the links between eating habits and sleep in kindergarten children.~      The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be~     concomitantly and longitudinally associated with compromised cognitive, emotional and~     behavioral functioning in kindergarten children; (b) In comparison to the HNI group,~     children in the HSI group will extend their total sleep time, improve their sleep quality~     and their sleep schedule will be more stable following the intervention; (c) improvement in~     sleep habits will be associated with improvement in cognitive, emotional and behavioral~     functioning; (d) in comparison to the HIS group, children in the HNI group will improve~     their eating habits, engage in more physical activities and better manage to achieve and~     maintain an age-appropriate body weight.~   "
75489|NCT02069236|"~     In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase~     enzyme activity in capillary blood obtained from a finger stick versus a venous blood~     specimen. As secondary endpoints we will seek to correlate phenotype as determined by~     quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing~     with flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic~     test evaluation studies.~   "
75490|NCT02069223|"~     Bariatric surgery procedures promote weight loss by limiting the amount of food consumed~     through reduction of the size of the stomach and by decreasing absorption of nutrients~     through reorganizing or bypassing portions of the small intestine. Among the procedures used~     to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as~     the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It~     was then offered by laparoscopy as a staged-approach in order to reduce peri-operative~     complications in high-risk patients. The second step of the surgery (i.e. the duodenal~     switch) was planned when sufficient weight loss had been obtained. However, it was observed~     that some patients experienced appreciable weight loss with the SG alone, and did not~     require a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery.~     This led to the surge in popularity of SG as a stand-alone operation, because of its~     relative technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been~     postulated to induce metabolic recovery and weight loss following surgery. The independent~     effects of each component of the BPD-DS with SG have never been investigated in humans~     within a well-controlled study design. The general objective of the present project is to~     assess the impact of each component of the BPD-DS and SG, either combined of separated, on~     physiological variables potentially responsible for metabolic recovery. Patients will be~     randomized to undergo one of three surgical sequences: 1) SG followed by BPD-DS one year~     later; 2) BPD-DS followed by SG one year later; or 3) SG and BPD-DS within a single~     operation. A series of tests will be performed at baseline, at 1 year, and 2 years after the~     initial surgery. We propose two Specific Aims to asses 1) the impact of each surgical~     component on the hormonal determinants of metabolic recovery; and 2) the impact of weight~     loss responses on subcutaneous and visceral adipose tissue function improvements. This~     project will help better understand the mechanisms underlying metabolic recovery following~     weight loss surgery.~   "
75491|NCT02069210|"~     The purpose of this study is to investigate the effect of transfusion of allogeneic~     (homologous) red cells on the immunologic parameters such as T-cells as well as natural~     killer cell count/function, various interleukins, TNF alpha and other immunologic relevant~     parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.~   "
75492|NCT02069197|"~     The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD)~     treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea~     (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This~     will be a randomized, open-label three arm controlled study comparing weight loss in obese~     participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with~     3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in~     participants treated with orlistat 120 mg TID and lifestyle intervention consisting of~     dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants~     treated with only lifestyle intervention consisting of dietary advice, recommended caloric~     goal of 1600 kcal/day (Group C).~   "
75493|NCT02069184|"~     Post-operative pain management after C-section is an important topic as the number of~     elective c-sections increases each year. Pain is managed either by giving opioids or by~     using non-opioids. The purpose of this study is to evaluate the effectiveness of IV~     Acetaminophen in pain relief and its impact in the usage of post-operative opioid~     requirements and opioid associated complications. The hypothesis is that four doses of IV~     Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients~     after c-section will reduce post-operative opioid requirements and opioid associated~     complications.~   "
75494|NCT02069171|"~     The purpose of this study is to identify the incidence,feature,clinical significance for leg~     lymphedema after gynecologic cancer treatment.~   "
75495|NCT02069158|"~     This is a phase Ib single arm, open-label, multiple dose, dose escalating, safety,~     pharmacokinetic and pharmacodynamic study of the combination of PF-05212384 with paclitaxel~     and carboplatin. The study will be conducted in adult patients with advanced breast, NSCLC,~     ovarian or endometrial, small cell lung cancer (SCLC) and Head and Neck (HNSCC) cancer for~     whom there is an indication to the use of paclitaxel and carboplatin.~      Successive cohorts of patients will receive escalating doses of PF-05212384 in combination~     with paclitaxel and carboplatin, starting at a dose level determined to be the 60% of single~     agent MTD.~      The study will consist of two parts: the dose finding part (Part 1) and the expansion part~     (Part 2).~      During Part 1 patients with breast, NSCLC, ovary and endometrial, small cell lung cancer~     (SCLC) and Head and Neck (HNSCC) cancer will be enrolled.~      During Part 2, only patients with ovarian cancer will be enrolled. In Part 1, a 3+3 design~     is employed. Once the MTD of the combination is defined in Part 1, Part 2 is performed for a~     better definition of the safety profile, of the potential antitumor activity and of the~     pharmacodynamic effects of the combination; it will be conducted in at least 12 patients~     with ovarian cancer.~      Approximately 40 patients are expected to be enrolled in the study overall.~   "
75496|NCT02069145|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of~     each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on~     safety in this study, additional lower or intermediate dose levels may be evaluated.~   "
75497|NCT02069132|"~     The purpose of this study is to validate the International Warfarin Pharmacogenetics~     Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older)~     with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid~     condition, and to assess the algorithm's prognostic relevance.~   "
75498|NCT02069119|"~     To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous~     intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to~     patients with paroxysmal or persistent atrial fibrillation~   "
75499|NCT02069106|"~     Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with~     mixed hyperlipoproteinemia.~   "
75500|NCT02069093|"~     Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in~     Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer~   "
75501|NCT02069080|"~     In mouse models and in patients, expression of the chemokine receptor CXCR4 on various~     cancers has been correlated with aggressive biological behavior, including increased rates~     and certain sites of metastasis, and decreased survival. Plerixafor (Mozobil ; Genzyme;~     Cambridge, MA) has been identified as a specific inhibitor of CXCR4, and it is currently~     approved by the Food and Drug Administration as a stem-cell mobilizing agent in combination~     with granulocyte colony-stimulating factor in the treatment of non-Hodgkin's lymphoma and~     multiple myeloma. Our group has recently shown that plerixafor can be labeled with the~     positron-emitting radionuclide copper-64((64)Cu) to form (64)Cu-plerixafor, which can be~     used to visualize CXCR4-positive tumor xenografts in mice using small-animal positron~     emission tomography (PET). Determining CXCR4 expression in tumors using (64)Cu-plerixafor~     and PET/computerized tomography (CT) scanning could be useful in predicting tumor behavior~     and responses to current and experimental therapies, including therapies targeting CXCR4,~     which could lead to more effective personalized cancer treatments.~      This study s primary objective is to evaluate (64)Cu-plerixafor as an imaging agent for~     quantifying CXCR4 expression in subjects (greater than or equal to 18 years of age) with~     cancer; at least 1 detectable solid tumor of greater than or equal to 2 cm in diameter found~     outside of the lymph nodes, bone marrow, liver, gallbladder, kidney, bladder, and brain; and~     preexisting biopsies of the tumors obtained since the first detection of the current~     occurrence/recurrence of disease. The secondary objectives are to correlate~     (64)Cu-plerixafor standardized uptake value in the target lesion with the level of CXCR4~     expression detected via immunohistochemistry and to calculate human dosimetry for~     (64)Cu-plerixafor.~      Preexisting tumor biopsies from less than or equal to 75 subjects recruited from the~     National Cancer Institute and the Georgetown University Hospital will be evaluated for CXCR4~     expression via immunohistochemistry. Subjects who meet the eligibility criteria will~     continue onto the study. Five subjects with CXCR4-positive tumor biopsies will be~     administered an initial intravenous infusion of (64)Cu-plerixafor (8 +/-0.8 mCi ; 0.48+/-~     0.048 rem; not to exceed 5 microg of (64)Cu -plerixafor) over 2 minutes. They will then~     undergo an initial low-dose transmission CT scan followed by 3 consecutive torso PET scans~     as soon as practical after the infusion, and 2 additional PET/CT scans at 4 hours +/- 1 hour~     and 24 hours +/- 2 hours post-infusion. Human dosimetry will be calculated based on these~     results, and a maximum dose will be used, not to exceed the calculated limit of a total~     effective dose of 5 rem, or the radiation exposure limit for each organ. The remaining~     subjects with CXCR4-positive (n=15) and CXCR4-negative (n=5) tumor biopsies will be~     administered 64Cu-plerixafor at the same, or a newly calculated dose, and will undergo 1~     PET/CT scan between 1 and 4 hours post-infusion, depending on the dosimetry results. All~     subjects will undergo one comprehensive final study visit between study days 19 and 23~     (11-17 days after injection with (64)Cu -plerixafor). Additionally, blood will be collected~     2 more times between study days 13-16 and study days 26-30 to measure blood cell counts.~   "
75502|NCT02069067|"~     The purpose of this study is to describe how often advanced cancer patients experience~     breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these~     treatments are.~   "
75503|NCT02069054|"~     Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases.~     Although the clinical features of asthma and COPD may be similar, the pathogenesis of these~     diseases differs in many aspects.~      The aim of this study is:~        -  to evaluate airway inflammation in asthma and COPD,~        -  to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,~        -  to assess the relationship between markers of airway inflammation and airway remodeling~          in asthma and COPD patients.~      Material and methods:~        -  mild to moderate asthma patients diagnosed in accordance with Global Initiative for~          Asthma (GINA) guidelines,~        -  mild to moderate COPD patients diagnosed in accordance with Global initiative for~          chronic Obstructive Lung Disease (GOLD) guidelines,~        -  healthy subjects as controls.~      Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC),~     bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway~     wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial~     ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.~      We plan to compare airway inflammation and features of airway remodeling in asthma and COPD~     patients.~   "
75504|NCT02069041|"~     The main purpose of this study is to determine if the advised dose of ramucirumab is safe to~     be taken with chemotherapy treatment in participants with advanced liver tumors.~   "
75505|NCT02069028|"~     This is a systematic review and Meta-Analysis of interventions for implementation of~     Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction~   "
75506|NCT02069015|"~     The primary aim of the study is to determine if enhanced discharge from the emergency~     department will improve blood pressure control and self-care management. Enhanced discharge~     will include a hypertension intervention delivered by a touch-screen kiosk over a three~     month period.~   "
75507|NCT02069002|"~     The aim of the current study is to compare the effictiveness of three different psychosocial~     therapies for treating functional disorders caused by indoor air problems.~   "
88200|NCT01902836|"~     Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte~     Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients~     treated only with conventional treatment.~   "
75508|NCT02068989|"~     We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2~     diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood~     glucose readings reviewed during their intensive care unit stay. All subjects are consented~     and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are~     then followed up in 1 year and the HbA1C repeated to determine if they have developed~     diabetes mellitus over the course.~   "
75509|NCT02068976|"~     This is an observational epidemiologic multicentric study of follow-up a cohort for~     described the situation of patients with primary ovarian insufficiency in public population~     with respect to the age of apparition the primary ovarian insufficiency .~   "
75510|NCT02068963|"~     This non-interventional clinical study will be conducted to prospectively collect serial~     plasma and serum samples from treatment naïve subjects with chronic HCV infection who are~     initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility~     endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of~     HCV-infected patients undergoing HCV antiviral therapy.~   "
75511|NCT02068950|"~     The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance~     training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared~     to usual care.~   "
75512|NCT02068937|"~     One of the challenges in treating patients with heart failure (HF) is achieving clinical~     stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm~     developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for~     use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily~     applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to~     describe a randomized clinical trial protocol designed to assess the effectiveness of the~     AAD and of nonpharmacologic management in improving clinical stability and reducing the~     readmission rate at 90 days in patients with HF.~   "
75513|NCT02068924|"~     Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows~     single embryo transfer to be applied without compromising pregnancy rates after the first in~     vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less~     than 36 years old with good embryo quality. The policy of transferring more than one embryo~     after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies~     reported in Europe and United States over the past 15 years. These multiple pregnancies are~     the main disadvantage of ART because of their negative impact on obstetrical, neonatal and~     economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of~     development at the cleavage stage. With the development of physiologically-based sequential~     culture media, it has also been suggested that extending embryo culture to Day-5 in order to~     transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy.~     Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh~     blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing~     procedure.~      However a recent embryo freezing technique (vitrification) seems to show significant higher~     pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications~     have reported the outcome of single embryo transfer at blastocyst stage by a prospective~     randomized and comparative study including the results of fresh and frozen/thawed blastocyst~     by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .~      Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos~     to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization~     program with Single Embryo Transfer policy in a prospective and randomized study integrating~     the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification~     procedure.~   "
75514|NCT02068911|"~     The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal~     expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in~     home-ventilated neuromuscular patients.~   "
75515|NCT02068898|"~     The study will assess bioavailability of XS003 given as a single oral dose compared to~     Tasigna® given as a single oral dose in healthy male subjects.~   "
75516|NCT02068885|"~     This study will evaluate the effects of dietary composition on energy expenditure and~     chronic disease risk factors, while also exploring physiological mechanisms underlying these~     effects.~   "
75517|NCT02068872|"~     The rapid rise in obesity (body mass index (BMI) ≥ 30 kg/m2) in the US over the past decade~     is responsible for more disease and death than any other single factor. Severe obesity is~     associated with numerous co-morbidities contributing to increased mortality risk, including~     end stage liver disease. Liver transplantation is a life-saving procedure for patients with~     end stage liver disease and obesity is becoming increasingly prevalent in this population.~     In one study, 54% of patients undergoing orthotopic liver transplant (OLT) were either~     overweight or obese [body mass index (BMI) >25 kg/m2], and 7% were severely or morbidly~     obese (BMI > 35 kg/m2). In addition, weight gain after solid organ transplantation is common~     because of steroid-containing immunosuppression and physical inactivity from decreased~     exercise tolerance.~      Obesity has been shown to increase the surgical morbidity, including wound infections, wound~     dehiscence, and hernias after transplantation. More significantly, excess pretransplant body~     weight hinders the rate of improvement in health-related quality of life after liver~     transplantation[7].~      One possible approach for treating obesity after a liver transplant is to use bariatric~     surgery. Currently, bariatric surgery is established as the most effective means for both~     weight loss and resolution of metabolic disease in the morbidly obese. Recent publications~     emphasize the usefulness of bariatric surgery in the reduction of long-term cardiometabolic~     risk, cardiovascular disease incidence and mortality, and the management of uncontrolled~     type 2 diabetes (T2DM). In addition, it decreases mortality and improves both social~     functioning and quality of life.~      Bariatric surgery may improve eligibility for transplant in patients previously excluded due~     to excessive weight. Bariatric procedures, such as sleeve gastrectomy, allow for significant~     weight loss over time that greatly reduces or eliminates obesity related illnesses such as~     diabetes, high blood pressure and liver disease.~      According to the National Institutes of Health, bariatric surgery is reserved for patients~     with a BMI of > 40 or > 35 kg/m2 in the presence of major co-morbidities (e.g. type 2~     diabetes, hypertension, sleep apnea, heart disease, etc).~      A significant number of liver transplant candidates have obesity-related illnesses, thus~     putting them at risk for cardiovascular and metabolic complications post-transplant. In~     addition, patients awaiting OLT are typically no longer medically stable to undergo~     intensive diet and exercise regimens as treatment for their diseases. Finally, decreased~     activity and medications used to prevent liver graft rejection all contribute to increased~     weight gain following transplant. In fact, in a series of 320 non-obese liver transplant~     recipients, 21.6% of patients became obese within two years of transplant. These~     comorbidities also contribute to poorer post-transplant outcomes and development of what is~     known as the post-transplant metabolic syndrome. Morbidly obese patients (BMI > 40 kg/m2)~     may also have higher frequencies of morbidities such as prolonged hospitalization and~     readmission as well as infectious, wound, and cardiovascular complications after~     transplantation. Finally, intra-abdominal adiposity creates a technically more challenging~     operative dissection, but no data exist on whether it increases perioperative morbidity or~     mortality in liver transplant patients.~      Sleeve gastrectomy is the most attractive restrictive procedure in a liver transplant~     population for several key reasons. One, sleeve gastrectomy does not require the~     implantation of a foreign body, such as placement of an adjustable gastric band, which in an~     immunocompromised post-transplant patient raises concern for severe infectious~     complications. Secondly, as stated previously, sleeve gastrectomy is a purely restrictive~     procedure, and therefore is least likely to cause significant macronutrient and~     micronutrient deficiencies. Finally, when compared to other restrictive procedures, such as~     adjustable gastric band placement, it has a lower likelihood of treatment failure (i.e. <50%~     excess weight loss). In fact, recent reports describe not only high failure rates with~     adjustable gastric band placement, but also high reintervention rates for both band-related~     complications (e.g. band erosion, leakage, slippage, port infection and esophageal~     dilatation) and failure to lose weight such that as few as 54% of patients may have their~     band in place after 10 years.~   "
75518|NCT02068859|"~     Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint~     pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly~     effective, it causes substantial side effects including gastritis and gastric ulcer disease,~     renal impairment, hypertension, and thrombotic events. These types of oral medications are~     utilized by millions of Americans on a fairly regular basis in both over-the-counter~     preparations and prescription compounds. In recent years, topical preparations of NSAIDs~     have been used for localized pain as an alternate to oral administration with reported good~     analgesic efficacy. For example, they are often used for knee pain. There is little systemic~     absorption of NSAIDs with topical administration, and consequently less likelihood of~     systemic side effects.~      Though much less studied than oral NSAIDs, topical NSAID preparations are currently~     prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied~     commercially available products are diclofenac 1% compounds. Higher concentrations~     presumably provide higher tissue concentration leading to better and longer pain relief,~     along with a more prominent anti-inflammatory effect.~      The investigators will therefore compare the efficacy of available topical diclofenac 1% gel~     to that of diclofenac 8% cream. Specifically, the investigators propose to test the~     hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any~     increase in systemic toxicity.~      One hundred six patients presenting to the Cleveland Clinic Pain Management Department for~     the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or~     diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee~     over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and~     functional/disability status.~   "
75519|NCT02068846|"~     The purpose of this study is to analyze BK viral infection in salivary gland diseases;~     specifically, to determine a definitive relationship between BK Virus and HIV associated~     salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1~     to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary~     function/protein secretion will be correlated with BK polyomavirus titers. We expect that~     patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit~     from Ciprofloxacin.~   "
75538|NCT02068599|"~     The primary purpose of the study is to evaluate the change from baseline after 4 weeks of~     topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief~     of symptoms of primary OA affecting a single knee~   "
75539|NCT02068586|"~     This randomized phase II trial studies how well sunitinib malate or valproic acid works in~     preventing high-risk uveal (eye) melanoma from spreading to other parts of the body.~     Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents~     these cells from growing. Valproic acid may change the expression of some genes in uveal~     melanoma and suppress tumor growth.~   "
75642|NCT02067247|"~     The purpose of this study is to compare the accuracy and comparability and secondarily to~     assess the values achieved by measurement of the forearm BMD by DXA and SOS by BeamMed,~     relative to standard DXA evaluations at the FN and LS.~   "
75520|NCT02068833|"~     Favorable effects of bariatric surgery have been demonstrated in particular regarding~     increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased~     cardiovascular risk. After surgery, weight loss also leads to improvement of the chronic~     inflammatory state related to obesity, a strong predictor of the metabolic status. Although~     obese patients are often affected with type 2 diabetes and hypertension, both related to~     renal impairment, the existence of a distinct mechanism by which obesity would cause chronic~     renal insufficiency has been suggested. The mechanisms underlying obesity-related~     nephropathy have been proposed to involve hyperfiltration, expansion of mesangial cells,~     hyperperfusion leading to proteinuria and glomerulosclerosis, as noted in obese dogs. In~     humans, improvements in renal function may be observed following bariatric surgery, although~     some reported a possibility of increased nephrolithiases. Whether biliopancreatic diversion~     and gastrectomy alone have similar effects is uncertain. More prospective studies are needed~     to assess the impact of all types of weight loss surgery to reverse chronic renal~     insufficiency.~      The objective of this study is to document changes in microalbuminuria and metabolic~     parameters in patients with altered renal function undergoing bariatric surgery. Patients~     enrolled in the study will show renal function impairment as demonstrated by~     albumin/creatinine ratio alterations in 2 out of 3 measurements taking place before surgery.~     We will perform a prospective study of renal function markers (albumin/creatinine ratio) and~     metabolic parameters (blood lipids, glucose, insulin, inflammatory markers) before and 6,~     12, 24 months after surgery in patients with microalbuminuria at study onset~     (albumin/creatinine ratio 2.0-20.0 mg/mmol in men and 2.8-28.0 mg/mmol in women). Data will~     be analysed with repeated measures analyses in both subgroup. Thereafter, a linear~     regression model will be created to adjust for potentially confounding factors such as~     hypertension and diabetes. We hypothesize that patients with severe obesity and altered~     renal function, whether they are diabetic or not, have improved microalbuminuria and~     metabolic parameters following biliopancreatic diversion with sleeve gastrectomy or sleeve~     gastrectomy alone. The extent of renal function recovery will correlate directly with~     metabolic improvements.~   "
75521|NCT02068820|"~     The investigators hypothesis is that if sensitivity and specificity are found to be~     significantly higher than the current reports with Technesium-99 and ISB colorimetric dye,~     SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby~     limiting peri-operative morbidity. SLN biopsies might also improve the detection of~     metastatic disease, essentially lowering the recognized false-negative rate of standard~     lymphadenectomy analyzed by routine H&E pathologic analysis.~   "
75522|NCT02068807|"~     The balance of the redox state is important for normal embryonic and fetal development .~     During the perinatal period, a variety of conditions are responsible for an excessive~     production of free radicals. The following oxidative stress is exacerbated by a lack of~     antioxidant substances that have not yet matured. At the moment there are no therapeutic~     strategies with single or combined antioxidants that have been shown to be clinically~     effective.~      Breastfeeding is important for the contribution of the antioxidant defenses of the newborn~     and the nutritional status of the mother plays a key role because it influences the~     nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body ,~     but taken with food or supplements. The molecule carries out different activities :~     antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of~     inhibition of peroxidation of membrane lipids is peculiarly important for the photoreceptors~     and neurons whose membranes are rich with polyunsaturated fatty acids. Current evidence on~     its role as an antioxidant indicate that supplementation with lutein may play a significant~     role in the prevention of free radical disease in the newborn~   "
75523|NCT02068794|"~     This phase I/II trial studies the side effects and best dose of oncolytic measles virus~     encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to~     see how well it works in treating patients with ovarian cancer that has come back.~     Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian~     cancer cells.~   "
75524|NCT02068781|"~     Currently, the incidence of obesity and obesity-related disorders is reaching epidemic~     proportions, which entails an increasing burden for health care systems. The association of~     obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease,~     such as insulin resistance and hypertension, is often referred to as the metabolic syndrome.~     During recent years, salt-sensitivity of blood pressure has emerged as an additional~     cardiovascular risk factor that is related to obesity and other key components of the~     metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships~     are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a~     link between insulin resistance and hypertension in obese individuals. In addition,~     impairment of microvascular function was found to be associated with salt-sensitivity of~     blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a~     cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance.~     Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but~     was also found to impair endothelial function and thus lower NO-availability, which is~     characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are~     associated with both hypertension and insulin resistance, which is illustrated in patients~     with primary aldosteronism, but also in the general population.~      The investigators hypothesize that increased aldosterone levels in obese individuals lead to~     impairment of microvascular function through reduction of NO-availability. This~     microvascular dysfunction is suggested to play a central role in the pathogenesis of~     salt-sensitive hypertension and insulin resistance.~   "
75525|NCT02068768|"~     The purpose of this prospective clinical study is to examine the short-term safety and~     efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat~     one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.~   "
75526|NCT02068755|"~     Blood transfusion is a common procedure essential for the treatment of patients undergoing~     cardiac surgery. Inappropriate transfusions, however, not only incur needless healthcare~     costs, but increase unnecessary risks due to transfusion reactions and infectious and~     immunomodulative causes. Safe and appropriate patient care requires evaluated blood~     component prescription practices.~      Practically all patients undergoing cardiac surgery in Finland have a blood product booking~     from the Finnish Red Cross Blood Service. This registry contains large volumes of~     transfusion-related information on all Finnish patients undergoing cardiac surgery in~     Finnish centers. Participating hospitals were scattered to all geographical areas in Finland~     and concentrated to the most populated regions.~      Data on the blood product use, laboratory findings one month pre-operatively and 12 months~     post-operatively were available.~      Finnish hospitals have been required to provide information on hospital visits for the~     Finnish National Research and Development Centre for Welfare and Health for healthcare~     planning purposes. We used in part the original data sent by hospitals to the Finnish~     Hospital Discharge Register (FHDR).~   "
75603|NCT02067754|"~     The investigators planned this study to Patients with histologically confirmed metastatic~     gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer~     therapy : Extra blood sample collection during routine blood sampling.~   "
75527|NCT02068742|"~     Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients~     Undergoing General Anesthesia~      The main purpose of this study is to determine the incidence of early postoperative~     cognitive dysfunction in elderly patients and its time course.~      This study will first evaluate the preoperative cognitive function of elderly patients based~     on several criteria including complete patient history, laboratory and instrumental exams,~     and the following measures in order to identify conditions and pathologies that may~     influence cognitive function.~        -  Mini Mental State Examination~        -  Geriatric Index of Comorbidity~        -  Geriatric Depression Scale~      The following neuropsychological tests will be performed on the same day within 7 days of~     surgery (baseline):~        -  Trail Making Test B-A~        -  Digit Span~        -  Digit Symbol Substitution Test~      The three cognitive function assessments will be repeated at the following postoperative~     time points and the change from the preoperative baseline to each time will be evaluated:~        -  Day 2 (time point 1)~        -  Day 4 (time point 2)~        -  Between days 85 and 90 (time point 3)~      If the patient seems confused before the postoperative administration of these tests, the~     Neecham Confusion Scale will be used to evaluate the patient for the presence of~     postoperative delirium; if delirium is not detected, the cognitive function tests will be~     administered.~   "
75528|NCT02068729|"~     An evaluation of the incidence of complications resulting from far lateral spine surgery~     utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody~     Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the~     treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.~   "
75529|NCT02068716|"~     Our Aim is to identify patient risk factors and clinical practices associated with~     healthcare-acquired infections (HAIs) after cardiac surgery.~      We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of~     Thoracic & Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that~     elevate a patient's risk of developing HAIs. The results of this analysis will form the~     foundation for the development of standardized regional practices to reduce HAIs. We will~     explore the effect of traditional patient-level measures (age, sex, comorbid conditions),~     process measures (timing and selection of antibiotics, continuous insulin infusion,~     transfusions), and surgical practices (use of bilateral internal mammary artery usage among~     diabetics, vein harvesting approach).~   "
75530|NCT02068703|"~     To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise~     machine) in hospitalized patients can positively affect subjective symptoms of sleep~     quality, fatigue and pain.~   "
75531|NCT02068690|"~     To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single~     rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI~     425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral~     drinking solution fasted compared to BI 425809 tablet fasted and tablet fed~   "
75532|NCT02068677|"~     1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response~     during injection when compared with subjects who do not experience sympathetic response~     during injection.~      EUS-CPN when performed in subjects who experience a sympathetic response during injection~     will have better pain relief when compared to subjects who do not experience a sympathetic~     response during injection.~   "
75533|NCT02068664|"~     The purpose of this study is to determine if stroke survivors with aphasia have spatial~     neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered:~     which is prism adaptation treatment. This is a pilot study that will be performed with 4-5~     subjects.~   "
75534|NCT02068651|"~     Advance care planning has been recommended as an integral part of care for patients with~     life-limiting disease, but relevant development in Hong Kong is still in its infancy. This~     proposed study attempts to address this service gap by promoting advance care planning to~     patients with advanced disease. It is hypothesized that the proportion of patients whose~     end-of-life care preferences were known in the experimental group will be significantly~     higher than that in the control group.~   "
75535|NCT02068638|"~     Whereas physical activity clearly results in improvements in glycemic control in type 2~     diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar~     control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin~     levels during exercise is a key factor that contributes to an increased risk of~     exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially~     difficult in patients on a multiple daily injection regimen, alternative strategies are~     required to improve exercise-associated glucose stability. There is increasing evidence that~     the combination of steady state continuous low to moderate intensity exercise with short~     bursts of high intensity exertion (eg in the form of sprints) is an effective, well~     tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising~     option to stabilize blood sugar levels during and after exercise may be the ingestion of~     fructose in addition to glucose in form of a sport drink.~   "
75536|NCT02068625|"~     This randomised, double-blind, placebo-controlled clinical trial investigates the~     neuroprotective effect of rasagiline in patients suffering from a retinal detachment~     affecting central vision. Based on results from a study in mice suffering from retinal~     degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the~     retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a~     second-generation propargylamine with neuroprotective properties modulating the~     caspase-dependent pathway of programmed cell death.~   "
75537|NCT02068612|"~     Physiological and neurocognitive changes experienced as a result of increasing age may~     influence socioemotional functioning and economic behaviors, yet, the mechanisms through~     which these changes occur are not well understood. Studies have also shown that aerobic~     exercise may protect against age-related cognitive decline in other domains. This research~     is designed to test the hypothesis that aerobic exercise will enhance social, emotional and~     economic functioning in older adults, and that these effects will occur via the effect of~     exercise on neurocognitive structure and function assessed via magnetic resonance imaging~     (MRI). Advancing our knowledge of the mechanisms that influence emotional, social and~     economic functioning could inform the development of targeted treatments and prevention~     programs for older adults.~   "
75540|NCT02068573|"~     AsthmaVent is a multi-center study, investigating the association between indoor air quality~     and childhood asthma.~      In Denmark, we spend more and more time indoors. Our houses are built airtight to save~     energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever~     before. We know that indoor air contains many different components that can affect our~     airways inappropriately and particularly children with asthma, who have sensitive airways~     are sensitive to these components. The AsthmaVent project examines whether increased~     ventilation is able to improve the indoor environment to such an extent that the asthma~     disease control, for children with asthma and house dust mite allergy improves, resulting in~     need for less medication.~      Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both~     the indoor air quality and on children's health and quality of life. There is not currently~     a consensus in this area, as studies so far have not been large or good enough to~     confidently determine the effect.~      This project is big and is designed so that it takes into account the sources of error seen~     in previous studies on the topic.~      We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house~     dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding,~     Randers and Herning. They are divided into two groups, receiving either active ventilation~     or placebo ventilation, meaning a non-functioning ventilation system that just recirculates~     the air in the room. Ventilation systems are installed in the fall and winter and ventilate~     the child's bedroom during 9 months. Indoor air quality and asthma control are assessed~     every 3 months, both at home visits were air quality and allergen levels of house dust mites~     are studies and at visits to the outpatient clinics with control of asthma parameters and~     quality of life.~      The project involves collaboration between several institutions with an interest in indoor~     air quality in relation to allergies and asthma and with great expertise in the field.The~     project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a~     center consisting of several institutions in Denmark dealing with indoor environment:~     Department of Public Health at Aarhus University and University of Copenhagen, Danish~     Building Research Institute and the Technical University of Denmark.~      Since asthma is the most common chronic childhood disease in Denmark and since the~     development of allergies and asthma has high social and personal costs, it is important for~     both society and the individual family, to find out whether simply improving the indoor air~     quality by increased ventilation can lead to an improvement in asthma disease control.~   "
75541|NCT02068560|"~     There is substantial evidence that women throughout life have significantly lower plasma~     levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of~     this is not yet fully elucidated, but in relation to the observations of lower pAVP levels,~     no significant difference in renal response parameters was found. This could be interpreted~     an increased renal sensitivity in females compared to males. The theory of increased renal~     sensitivity in females is supported by a few pharmacodynamic studies currently available on~     this topic. However none of the studies was designed with the purpose of investigate the~     gender difference.~      The aim of this study is to investigate possible gender differences in the renal sensitivity~     to dDAVP and the effect of age on these differences. This will be done by low dose graded~     infusion of the synthetic AVP analog dDAVP.~      Participants are 80 healthy volunteers equally distributed between four age groups, 8-10~     years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.~   "
75542|NCT02068547|"~     The purpose of this research is to test if that combining bone marrow aspirate (removing~     bone marrow with a needle) concentration with locally harvested (collected) autograft~     (patient's own bone from another part of the body) for use as the bone graft results in~     equal rates of a successful procedure (fusion), as compared to current best practice in~     high-risk patients undergoing posterior cervical fusion.~      Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft~     results in equivalent rates of bony fusion, as compared to current best practice in~     high-risk patients undergoing posterior cervical decompression and fusion.~   "
75543|NCT02068534|"~     The current study aims to explore the risk factors, protective factors, resilient factors,~     and factors jeopardizing the recovery progress on survivors from charcoal-burning suicide.~     To this end, an in-depth individual interview and Mini-Mental State Examination(MMSE) will~     be used to acquire the first-hand information on the attempters. As well, a more~     comprehensive neuropsychological test, WAIS III, will be administered at 3-month, 6-month,~     and 12-month after the index suicide attempt.~   "
75544|NCT02068521|"~     Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan~     administration.~      Patients will be monitored for safety throughout their participation in the study. Safety~     will be monitored by physical examination, inspection of injection sites, vital signs,~     clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead~     ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan),~     PK/PD assessments, and immunogenicity assessments.~      Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using~     CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug~     dictionary.~   "
75545|NCT02068508|"~     The purpose of this study is to investigate the safety and efficacy of long-term treatment~     with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with~     combination with an insulin product in patients with type 2 diabetes mellitus who responded~     inadequately when using an insulin product in addition to diet therapy and exercise therapy.~   "
75546|NCT02068495|"~     This study will investigate the safety and efficacy of long-term use of candesartan~     cilexetil/amlodipine combination tablets (Unisia Combination Tablets) LD, HD in patients~     with hypertension in the normal clinical setting.~   "
75547|NCT02068482|"~     Diverticulosis of the colon is a frequent condition in adults in western countries and a~     significant number of patients experience clinical symptoms even when the diverticulosis is~     not complicated by diverticulitis.~      Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular~     Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological~     abnormalities.~      The Study Protocol is verify the modifications in the immunological pattern induced by~     reducing bacteria related activation of immunity by Rifaximin treatment.~   "
75548|NCT02068469|"~     The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and~     assay for detecting Strep A at the point of care lab compared to culture.~   "
75549|NCT02068456|"~     The purpose of this study is to evaluate the safety and efficacy of roflumilast in the~     real-use conditions with its registered indications.~   "
75550|NCT02068443|"~     The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with~     metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2~     diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg~     in addition to diet and exercise therapy.~   "
75643|NCT02067234|"~     The goal of the current investigation is to determine whether the inclusion of a~     parent/patient psychoeducational session in initial dermatology appointments with new~     pediatric atopic dermatitis patients affects (a) extent of medical follow-up, (b) patient's~     quality of life, and (c) parenting stress in comparison to treatment as usual for initial~     pediatric dermatology appointments for new pediatric patients with atopic dermatitis.~   "
75551|NCT02068430|"~     This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal~     Collagen Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to~     use the eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light.~     The eye drops are placed in affected eye and then affected cornea is exposed to UVA.~      UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in~     Dresden, Germany. Data to date obtained mostly by physicians outside the United States has~     strongly suggested this treatment as an acceptable alternative, and many subjects have had a~     lasting effect (no progression) 3-5 years after their initial treatment.~   "
75552|NCT02068417|"~     The objective of the pilot study is to assess the feasibility of a full randomised,~     placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave~     application in patients with erectile dysfunction of vascular origin leads to a greater~     increase in potency than in the control group.~   "
75553|NCT02068404|"~     Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO,~     15 million children are born prematurely (gestational age < 37 weeks) in the world each year~     while 7% of them die because of complications associated with prematurity. Despite constant~     improvement of obstetrical care, the number of preterm births has increased over the last~     decades and prematurity is still the most frequent cause of prenatal hospitalization in~     industrialized countries.~      The American College of Obstetricians and Gynecologists as well as the Royal College of~     Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of~     acute threatened preterm labour. Clinical experience show however an important variability~     in treatment response among pregnant women. In spite of its large use in obstetrics as a~     tocolytic agent, nifedipine is prescribed off-label. As a consequence no international~     consensus on optimal dose schedule has so far been proposed.~      Small sample size and heterogeneousness of tocolysis administration protocols make it~     difficult to compare the little data available on the pharmacokinetics of nifedipine in~     pregnant women. Nevertheless an important interindividual variability in concentrations has~     been identified (CV=12-76%) but very few studies have investigated the possible reasons of~     this variability in pregnant women. Genetic and environmental factors involved in drug~     distribution and metabolism (e.g. enzymatic activity, CYP 3A5 genotype) might partially~     explain variability in drug levels and therefore differences in treatment response.~      The goal of this study is to quantify the variability in nifedipine pharmacokinetics and~     identify potential genetic and non-genetic sources of variability in nifedipine~     pharmacokinetics in pregnant women. The relationship between concentration and treatment~     response will be evaluated and will serve to propose optimal dosage regimen to improve~     efficacy and reduce side effects associated with this treatment.~   "
75554|NCT02068391|"~     Silent ischemic, also known as covert stroke vascular disease (CSVD), contributes to~     neurological deficits that are caused by damage to small blood vessels in the brain. CSVD~     occurs six to ten times more often that an acute stroke. It is misleading to think, however,~     that CSVD is an inevitable part of getting old because people with CSVD are at high risk~     of developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are~     more likely to develop day to day problems in planning, decision-making and speed of~     thinking. Unfortunately, there are no proven therapies designed to address CSVD. We propose~     to test whether aerobic exercise is an intervention that can combat CSVD because the disease~     is fundamentally a blood flow problem that may be improved by aerobic exercise. We will~     recruit CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging~     (MRI) to study the brain in terms of structure, perfusion and function. Participants will be~     randomly assigned to either our established aerobic exercise program or a control stretching~     program. Both groups will take part in lab exercise sessions, which are designed to monitor~     progress and assess adherence to the program. The duration and intensity of their exercise~     will increase as participants progress. We will use activity log books, phone calls and~     extra booster exercise sessions, as needed, to maximize retention and adherence. We aim to~     show that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey~     matter, supports regional tissue growth, and improves cognitive function in CSVD adults with~     substantial risk of acute stroke and dementia. A positive outcome of this research will~     provide strong support for additional clinical trials aimed at sustaining cognition and~     maintaining independent living.~   "
75555|NCT02068378|"~     Lung cancer is the second most common cancer in the United Kingdom with around 40,000 new~     cases diagnosed every year. Lung cancer is associated with a very poor prognosis (<10%~     patient survival at 5 years). New strategies are urgently needed to improve survival in this~     group of patients.~      The most effective and common treatment for lung cancer is radiotherapy (either alone or~     combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are~     given to the tumour. However, increasing the radiotherapy dose carries an increased risk of~     damage to the surrounding healthy tissue. Damage can be minimised by reducing movement~     within the lung, caused by factors such as breathing and patient motion, during treatment.~      This study tests a new medical device that has been developed to monitor and help patients~     control their breathing and movement during treatment. Optical sensors will detect any~     motion of the patient's torso and this will be fed back to the patient in the form of a~     visual aid allowing them to regulate their breathing and maintain their ideal treatment~     position.~      The device has already been shown to reduce motion in healthy volunteers. In this study the~     investigators hope to demonstrate that the visual aids are tolerable in lung cancer~     patients. The investigators additionally aim to show the device will help reduce movements~     of the chest and also the lung tumour, leading to improvements in treatment results.~   "
75556|NCT02068365|"~     This is a multi-center, single-arm, open-label study on the virological response of chronic~     HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on~     nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate~     the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at~     24 weeks after the end of treatment.~   "
75557|NCT02068352|"~     The purpose of this study is to investigate the effectiveness and safety of 2 concentrations~     of OPA-15406 compared to vehicle in subjects with atopic dermatitis.~   "
75558|NCT02068339|"~     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)~     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1~     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited~     the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also~     some research reported that LXRg (a member of the nuclear hormone receptor)-mediated~     increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the~     expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg~     and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and~     LXRg-SREBP-1c pathway in liver.~   "
75559|NCT02068326|"~     Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in~     adolescents younger than 18 years according to the Diagnostic and Statistical Manual of~     Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably~     diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD~     exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly~     shown to be effective in treating adult BPD, but in the case of adolescents, only individual~     MBT have been tested and found to be effective.~      Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory~     programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As~     Usual (TAU) in treating adolescents with BPD or subthreshold BPD.~      Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region~     Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V~     BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up~     will be at three and 12 months.~      Discussion: Early intervention is especially important in relation to personality~     psychopathology and has long-term benefits for patients, their families and society. In~     addition to being cost effective, using the group modality in the treatment of BPD may have~     several advantages. This is the first Randomized Controlled Trial (RCT) to test the~     effectiveness of MBT in groups for adolescents.~   "
75560|NCT02068313|"~     Phase II and III studies have demonstrated IMRT to be safe and standard practice for head~     and neck cancers treated with radiotherapy. This study will be an extension to an earlier,~     in-house, trial to allow continued recording of toxicities and outcomes in patients~     receiving IMRT for head and neck cancers. This study will allow us to examine~     radiobiological modelling for normal tissue complication probability and in particular,~     determining the dose threshold for parotid glands. Our primary objective is to assess the~     potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in~     head and neck cancer patients and determining threshold dose for whole parotid gland and~     superficial lobes of parotid glands~   "
75561|NCT02068300|"~     The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol~     (1,5-AG) as a novel surrogate marker of hypoglycemia~   "
75562|NCT02068287|"~     Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the~     inflammatory response. Experimental works demonstrated that Esmolol, an highly selective~     beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono~     centric, double blind, randomized clinical work in septic shock patients has shown that~     Esmolol administration is safe and reduces effectively heart rate. However there are only~     sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human~     resuscitated septic shock patients treated by esmolol.~   "
75563|NCT02068274|"~     Opioids are an effective instrument for patients with acute and chronic pain. Their route of~     administration ranges from transdermal to subcutaneous application through to Intravenous~     Patient-Controlled Analgesia (IV-PCA).~      The use of IV-PCA-pumps has considerable advantages including decreased delay in the~     administration of opioids from the time requested, individual dose intervals, self -control~     of their therapy, rapidity and ease of dose titration . These potential benefits, however~     are balanced by the need for careful assessment of adverse effects, including decreased~     quality of life because of the patient's sedation, constipation and possible episodes of~     bradypnoea and desaturation, eventually leading to respiratory depression (RD) requiring~     treatment. Often described safety features that help prevent overdosing are PCA bolus dose,~     delay, and lockout interval.~      Even though the risk of serious, potentially life threatening complications by using IV-PCA~     without a background infusion was described to be very low (0.24%) compared to other methods~     of opioid delivery , adverse effects like worrying degrees of hypoxemia and bradypnoea do~     occur and often remain undetected due to the lack of continuous monitoring. One of the~     possible causes of patient harm are medication errors associated with PCA administration, a~     common form of PCA errors, which is a significant source of preventable patient morbidity~     and hospital resource utilization.~      The individual patient response to a particular dose of opioids depends on diagnosed or~     unrecognized comorbidities. Clinical experience has shown that it is not possible to~     prospectively identify all patients who may be at increased risk.~      Conventional opioid monitoring protocol may fail to detect frequent episodes of bradypnoea~     and desaturation measured by the respiratory rate (RR) and Saturation of Peripheral Oxygen~     (SpO2) because even at a low respiratory rate SpO2 is usually maintained, so that pulse~     oxymetry might fail to detect respiratory deterioration, particularly if a patient is~     receiving supplemental oxygen.~      Therefore, continuous monitoring could be considered more sensitive, especially if it~     contains the measurement of Partial Pressure of Carbon dioxide (PCO2), which is a good~     parameter for monitoring ventilatory function.~      The 'gold standard' method to measure the arterial partial pressure of carbon dioxide~     (PaCO2) is still the arterial blood gas analysis. But arterial sampling including~     catheterization or intermittent arterial puncture is invasive and expensive and associated~     with pain and discomfort for the patient. Therefore cutaneous carbon dioxide tension (PcCO2)~     measurement was suggested to be used as a non-invasive surrogate measure of PaCO2.~      SpO2, and tcPCO2, are important clinical parameters that should be used in conjunction with~     each other. SpO2 reflects oxygenation, while tcPCO2 reflects ventilation; the first can~     still be normal while the second may herald early changes in respiratory status. Capnography~     may provide the earliest indication of opioid-induced respiratory depression. It is~     important to monitor changes from a baseline tcPCO2 level. As the tcPCO2 level starts to~     increase, early intervention and changes in medication can be made.~      The present study aims to examine combined oxymetry and transcutaneous capnography using a~     single earlobe sensor (V-Sign™, Sentec AG, Therwil, Switzerland) in chronic pain patients~     treated with opioids where non-invasive monitoring of ventilation is needed because~     ventilatory disturbances are suspected. This may, potentially, improve patient's quality of~     life.~   "
75564|NCT02068261|"~     The purpose of this study is to evaluate the effects of a computerized working memory~     training program on substance abuse, psychosocial functioning, cognitive performance and~     psychiatric problems in adults with substance abuse and attention problems.~   "
75565|NCT02068248|"~     Research over the past several decades have linked the intake of dietary fiber with lower~     blood cholesterol levels. The distinction between soluble and insoluble fiber fractions~     emerged shortly after and there is now a general consensus that soluble fiber possesses the~     capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of~     soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction~     from these fibers. In order to handle the inconsistencies a full and systematic review of~     the published literature was conducted by Brown et. al (1999). Results from this~     meta-analysis, concluded that 'increasing soluble fiber can make only a small contribution~     to lowering cholesterol.'~      Research is constantly progressing and new research findings may not always be consistent~     with older data. For example, results from new research are now challenging the previously~     approved health claims for soy foods and fatty acids. This is a major public health concern~     because if clinical evidence is not reliable, it could lead to harm. Since the publication~     of the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to~     research the effects of soluble fiber on cholesterol levels with new technology and trial~     designs, therefore it is crucial to revisit the question and update the literature on the~     effect of viscous soluble dietary fibers on serum cholesterol levels.~      A series of meta-analyses will be performed to assess the link between viscous dietary~     fibers and serum cholesterol levels. Nutritionists now consider fiber to be an integral part~     of diet and disease. Results from these meta-analyses help address the question of whether~     viscous soluble fibers have a role lowering serum cholesterol levels.~   "
75566|NCT02068235|"~     This study consists of a single-dose pilot phase and a randomized, two-way crossover,~     single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of~     the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod~     formulation. Three subjects will be included in the pilot phase and 12 subjects in the main~     crossover phase.~   "
75567|NCT02068222|"~     The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and~     ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.~   "
75568|NCT02068209|"~     The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during~     outpatient hysteroscopy.~   "
75569|NCT02068196|"~     The goal of this study is to understand how ipilimumab is being used, its safety profile,~     and the manner in which Adverse Reactions are managed in routine clinical practice. Another~     goal is to identify predictive biomarkers. The study is an observational study and not~     intended to test any hypothesis, but can be hypothesis generating.~   "
75570|NCT02068183|"~     The proposed study builds upon preliminary studies in self-selected populations to identify~     opportunities for early identification of World Trade Center-related health consequences in~     adolescents. If adverse health consequences are identified, proactive cardiometabolic and~     pulmonary screening of exposed children may be indicated, with targeted interventions~     intended to prevent development of chronic obstructive pulmonary disease, and adverse~     cardiometabolic outcomes in adulthood.~   "
75644|NCT02067221|"~     The objective of this research is to investigate the surgical outcomes of minimally invasive~     percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients~     with renal stone larger than 1cm.~   "
75571|NCT02068170|"~     A prospective, observational study in a university hospital (UZ Leuven). Patients are~     included when they are treated with a potentional QT-prolonging drug: haloperidol for~     delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin,~     erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole,~     voriconazole), methadone, tacrolimus and oral oncolytics.~      An ECG is taken before the administration of the drug and 3-5 days after starting the drug~     to investigate the change in duration of the QTc-interval. Risk factors for developing~     QT-prolongation will be documented. Together with ECG2, an additional blood sample will be~     collected to measure the blood concentration of the drug.~   "
75572|NCT02068157|"~     This phase II trial studies the effects of interstitial photodynamic therapy in patients~     with head and neck cancer that has come back. Interstitial photodynamic therapy uses a~     combination of laser light and a light-sensitive drug called porfimer sodium to destroy~     tumors. During treatment a laser light is used to activate the drug. Interstitial~     photodynamic therapy may be an effective treatment for head and neck cancer.~   "
75573|NCT02068144|"~     The purpose of this study is to determine the health benefits of cranberry extract in people~     who are at risk for diabetes and heart problems.~   "
75574|NCT02068131|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection plus capecitabine in treating patients with metastatic~     colorectal cancer who have progressed after standard therapy.~   "
75575|NCT02068118|"~     Targeted population: Patients with heart failure causing hospitalization during the last~     twelve months.~      Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the~     Telecardiology group than for the reference group (standard follow-up care). An 18 months~     period of observation is required.~      Main goal: To compare the rate of all cause deaths and hospitalizations of patients with~     heart failure between the Telecardiology group and the reference group after 18 months of~     monitoring.~   "
75576|NCT02068105|"~     This is a study to test the safety of ALKS 5461 in healthy adults.~   "
75577|NCT02068092|"~     This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil,~     on mammographic density in women at high risk of breast through assessing whether~     mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol~     for 1 year compared with baseline imaging.~   "
75578|NCT02068079|"~     The purpose of this study is to evaluate the safety of combination therapy with vemurafenib~     and trientine in patients with BRAF mutated metastatic melanoma.~      Vemurafenib is a drug that is currently approved by the United States Food and Drug~     Administration (FDA) and by the European Medicines Agency (EMA) to treat adult patients with~     melanoma that has spread to other parts of the body or cannot be removed by surgery. It can~     only be used in patients whose cancer has a change (mutation) in the BRAF gene.~      Preclinical data suggests that use of a copper chelator (reducer) is a strategy to block~     cellular signaling activity which would result in anti-tumor effects (slow tumor growth).~     Trientine is a copper chelator and is FDA approved for the treatment of Wilson's disease (a~     disease of copper metabolism) and is generally well tolerated. It works by binding to copper~     to help remove it from the body. Trientine is not FDA approved for the treatment of melanoma~     and its use in this study is investigational. Investigational means the study drug is~     still being tested in research studies.~      All patients will receive vemurafenib at 960mg PO twice daily with continuous dosing in~     combination with trientine in escalating doses. The dose of trientine will depend on what~     portion of the study.~      In order to participate in the study, patients must test positive for the change (mutation)~     in the BRAF gene.~   "
75579|NCT02068066|"~     Background: Physical activity is defined as any bodily movement produced by skeletal muscles~     resulting in energy expenditure (Caspersen, 1985). According to classical work physiology,~     energy expenditure was considered as basis for assessing the severity of manual work~     (Grandjean 1991). Steele et. al. found blue collar workers to report significantly more~     walking activity, daily step counts and MET min/week than professionals and white collar~     workers. However, the energy cost of physical activity may not necessarily be equivalent to~     body movement. Therefore, modern concepts include also other aspects reflecting the amount~     of workload. Soer et. al. applied an evaluation system consisting 12 work-related tests to~     establish functional capacity in healthy employees. The assessment included various lifting~     and energetic tasks as well as coordination exercises. In occupational rehabilitation a~     balance between workload and work capacity is necessary for professional reintegration.~     Thus, it is of great value to evaluate a wide range of work requirements across occupational~     groups in terms of energy expenditure, physical activity and aerobic capacity.~      Aim: The aim of this study is to examine the amount of physical activity and energy~     expenditure during a normal working day with focus on differences between occupational~     groups.~      Method: To analyze the situation in Switzerland, 300 healthy and full-time employed adults~     between 18-65 years will be investigated in the Basel region. Participants will be~     stratified by occupational category according to the ISCO-88 and will then be merged into 3~     groups with low-, moderate- and high-intensity occupational activity. By wearing the~     SenseWear Mini Armband on 7 consecutive days, average daily energy expenditure, activity~     duration at different intensities and step counts will be assessed during work-time. In~     addition, individual's aerobic capacity will be determined by the 20-meter shuttle run test.~      Outlook: This study is expected to provide detailed information about physical work~     requirements with regard to professional reintegration. For developing adequate intervention~     and treatment strategies, it is of great value to evaluate performance criteria across~     occupational groups.~   "
75580|NCT02068053|"~     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and~     extent of elimination, as well as safety and tolerability of a single oral solution dose of~     [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.~   "
75581|NCT02068040|"~     The major goal of this proposal is to characterize the ability of epicatechin which a~     component of dark chocolate to improve the~        1. structural and functional features of skeletal muscle (SkM)~        2. exercise capacity (as assessed by VO2 max)~        3. parameters of diastolic heart function (as assessed by echocardiography)~      We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead~     to a significant improvement in exercise capacity and diastolic function.~   "
75582|NCT02068027|"~     The purpose of the study is to determine whether clonidine gel is an effective treatment for~     reducing the pain associated with painful diabetic neuropathy.~   "
75583|NCT02068014|"~     Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the~     procedure, cutting of the stomach is performed with differents long of stapplers.~      The aim of the study is to determine wich long of stappler is applicable in any stage of the~     procedure ans the variation expected.~   "
77297|NCT02045602|"~     The purpose of this study is to determine the safety and tolerability of VCN-01 either~     administered alone or in combination with Abraxane®/Gemcitabine, and to determine the~     recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.~   "
75584|NCT02068001|"~     It has been suggested that obese people are more sensitive to sensory and rewarding effects~     of food, aspects that mediate food preferences and intake. Individuals that underwent~     Roux-en-Y gastric bypass surgery frequently report changes in food preference. They indicate~     a decreased preference for highly rewarding energy dense foods. Changes in food preference~     might be related to alterations in central (brain) mechanisms, related to reward sensing.~     The smell and sight of food can be considered as anticipatory cues for the rewarding effects~     of food intake. The aim of this study is to determine the effect of gastric bypass surgery~     on (alterations in) food preferences. Secondly, this study aims at assessing the effect of~     gastric bypass surgery on the brain reward response when exposed to sight and smell of food~     stimuli with different sugar and fat contents.~   "
75585|NCT02067988|"~     Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from~     intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic~     disease. Adjuvant liver-directed treatment is warranted to control both intra- and~     extrahepatic disease. Patients with liver metastases of NET will be included in this study~     (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after~     systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an~     interventional, treatment, non-randomized, open label, non-comparative, phase II study.~     166Ho-RE will be performed via a catheter during angiography.~   "
75586|NCT02067975|"~     Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents~     indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and~     dopamine. One way to reliably increase KYNA levels is by ingesting the amino acid~     tryptophan. Tryptophan is a normal part of the human diet. Tryptophan gets~     metabolized/changed to other chemicals in the body- including KYNA. By giving people 6 grams~     of tryptophan, the investigators will be able to increase the KYNA level in a controlled~     way. The investigators will then be able to study the effects of KYNA on neurotransmitters~     by using cognitive tests and magnetic resonance imaging techniques (measuring brain activity~     and brain chemistry using the MRI magnet). They will test people using tryptophan and also~     using a placebo to look for differences. The investigators will test healthy controls and~     people with schizophrenia to look for differences.~   "
75587|NCT02067962|"~     Juvenile idiopathic arthritis (JIA) is considered to be a multifactorial disease caused by a~     combination of environmental factors and predisposing genetic factors. Twins studies found a~     strong heritability (strong genetic factors) but genetic studies such association studies of~     large cohorts of patient (GWAS or Genome Wide Association Study) have elucidated less than~     20 % of the genetic basis of JIA. The vision of the genetics of multifactorial diseases has~     recently changed revealing a large clinical and genetic heterogeneity of these diseases.~     Indeed, the advent of next-generation sequencing identified non-multifactorial genetic~     hereditary disease related to mutations in genes having strong effect on the onset of the~     disease without real impact of environmental factors among the so called multifactorial~     diseases (Parkinson's, diabetes, osteoarthritis, Alzheimer's, hypertension ...)The~     investigators propose to study 30 families with several forms of JIA by next-generation~     sequencing. Identifying the genetic basis of JIA in these families will help to better~     understand the physiopathology of this disease and may help to the identification of novel~     therapeutic targets for other patients with JIA.~   "
75588|NCT02067949|"~     determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg)~     plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient~     from the societal perspective over one year.~   "
75589|NCT02067936|"~     The investigators study whether four equipotent combinations of propofol and remifentanil~     (as predicted by interaction models for tolerance of laryngoscopy) result in identical~     haemodynamic conditions, independent of their relative different balance between the~     concentration of propofol and remifentanil.~   "
75590|NCT02067923|"~     This study proposes to conduct a non-interventional, multi-center trial that will look at~     C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who~     received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal~     antibody is a humanized antibody that is commonly used to prevent organ rejection. It was~     give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly~     diagnosed type 1 diabetes.~      The overall hypothesis of this study is there will be less change in c-peptide levels of the~     previously treated group versus the control group.~   "
75591|NCT02067910|"~     Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by~     inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the~     mouth. Furthermore, many patients experience extraglandular symptoms such as restricting~     fatigue. Currently, biological agents have been introduced in various systemic autoimmune~     diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent~     has yet been approved for the treatment of pSS. In an open-label study, we have shown that~     abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore,~     the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment~     in pSS in a larger and randomized clinical trial.~   "
75592|NCT02067897|"~     Ingrown toenails occur when the nail grows into the surrounding skin, resulting in pain and~     infection. The most common procedure to treat this problem is a wedge excision (removal of~     part of the toenail) and matricectomy (destruction of part of the nailbed with chemicals or~     surgical instruments). This study will evaluate the effectiveness of an alternative~     technique called the Vandenbos procedure (where the skin is removed and the toenail is left~     intact). This procedure is currently being used by some of the pediatric surgeons at our~     hospital and we want to evaluate our results up to 6 months after surgery. We believe that~     the true recurrence rate will be greater than 0% but that recovery time and morbidity will~     be acceptable to most patients.~   "
75593|NCT02067884|"~     This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography~     in measuring response in patients with breast cancer receiving chemotherapy before surgery.~     New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography,~     may predict treatment response earlier and more accurately than contrast enhanced magnetic~     resonance imaging.~   "
77298|NCT02045589|"~     The purpose of this study is to determine the safety and tolerability of three intratumoral~     injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended~     phase II dose of VCN-01 combined with Abraxane®/gemcitabine.~   "
75594|NCT02067871|"~     -  The purpose of this study is to determine the effects of low-level laser therapy in~          combination with neuromuscular electrical stimulation on neuromuscular (muscular~          strength and morphology) and functional parameters (pain and functional tests) in~          elderly with knee osteoarthritis.~        -  The hypothesis is that the association of low-level laser therapy with neuromuscular~          electrical stimulation could reduce joint pain associated with the inflammation and~          consequently potentiates the effects of electrical stimulation on the muscular system.~   "
75595|NCT02067858|"~     The goals of this clinical research are to evaluate the outcomes and tumor response for~     early stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation~     Therapy (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed~     Tomography (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™)~     and body immobilization system (see figure 1). Specifically, the effect of image-guided SBRT~     treatment on clinical tumor response rate, local control and progression-free survival will~     be studied. This study will examine target volumes and relevant margins determined by an~     assessment using 4D PET and repeated 4D CT. These data will allow us to evaluate and~     determine the impact of the body immobilization system on the planning target volume (PTV)~     margins, patient's breathing pattern, target motion, and inter-treatment targets shifts.~   "
75596|NCT02067845|"~     The limited research that exists suggests that lesbian, bisexual and queer (LBQ) women are~     at similar risk for sexually transmitted infections (STI) as heterosexual women. This is a~     particularly important area to address, as literature highlights the convergence of sexual~     stigma and gender-based sexual violence as elevating LBQ women's risk for HIV and STI~     infection. However, recent Statistics Canada data indicated that: lesbians reported~     significantly lower rates of Pap testing than heterosexual or bisexual women; lesbians and~     bisexual women had higher odds of not having a regular doctor than heterosexual women; and~     bisexual women had higher reported unmet health care needs than lesbian and heterosexual~     women. These differences highlight the importance of implementing and evaluating~     interventions to address STI risk among LBQ women; however, no published study exists of~     this nature. A STI prevention intervention will be implemented with groups of LBQ women and~     WSW in Toronto and Calgary. The study has 5 distinct components: 1) key informant interviews~     to inform the development of the intervention training manual and survey questionnaire, 2)~     pre-test; 3) intervention (6 group sessions during a weekend retreat); 4) post-test directly~     following intervention, and 5) follow-up post-tests at 6 and 12 weeks. The study hypothesis~     is that, compared to pre-intervention, participants who receive the group-based intervention~     will report an increase in sexually transmitted infections (STI) knowledge~     post-intervention. The secondary hypotheses are that, compared with pre-intervention,~     participants will demonstrate higher mean scores of (a) safer sex self-efficacy; (b) STI~     testing; (c) safer sex practices; (d) resilient coping, (e) self-esteem, (f) social~     provisions, (g) community connectedness and (h) access to health care. We anticipated that~     compared to pre-intervention, participants post-intervention would report lower mean scores~     of (a) depression and (b) internalized stigma.~   "
75597|NCT02067832|"~     Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and~     contributes significantly to morbidity and mortality in stem cell transplantation patients.~      The research will look into identifying and validating cGVHD biological indicators~     (=bio-markers) which will be evaluated whether they can predict a future development of the~     disease.~      The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be~     present at the time of cGVHD diagnosis, will also be present at earlier time points, before~     cGVHD develops.~      Following validation, the bio-markers will be beneficial for finding those patients who are~     in higher risk to develop cGVHD.~      By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive~     therapy might be applied in order to prevent or reduce the prevalence of the disease.~   "
75598|NCT02067819|"~     The purpose of this study is to assess the feasibility of a trial on an oral orthotic for~     reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic~     Disorder (CTD).~   "
75599|NCT02067806|"~     The present study aims to evaluate the relationship between spinal block with 1% solution of~     2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events,~     with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome~     (CES).~   "
75600|NCT02067793|"~     The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a~     single intravenous dose in subjects with major depressive disorder.~   "
75601|NCT02067780|"~     Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the~     world. In a recent study, we showed that administration of levofloxacin is superior to~     placebo in the treatment of decompensation of COPD; it is accompanied by a substantial~     reduction in mortality and a significant reduction in the residence time in hospital.~      In Tunisia, few data are available on the epidemiology of COPD decompensation. The choice of~     antibiotic to be used in this situation is challenging to the clinician who must choose~     between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new~     antimicrobial agents. Recently, it has been emphasized the selection of patients for~     treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed,~     there would have a correlation between the tracheobronchial infection and elevated~     inflammatory markers. As the elevation of these markers is proportional to the intensity of~     the inflammatory reaction of the body, is based on the kinetics of these biomarkers in~     antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when~     to start antibiotics, but also through their kinetic, these markers can guide the duration~     of therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the~     antibiotic treatment was adopted.~      The objectives of this randomized prospective and double blind study are to evaluate the~     efficacy and safety of a short treatment of 48 with levofloxacin compared with treatment~     with the same molecule during a time guided by monitoring markers of inflammation in~     patients admitted to the emergency for exacerbation of COPD and to study the epidemiology of~     viral and bacterial COPD decompensation.~   "
75602|NCT02067767|"~     Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable~     regimen on the long-term. However this regimen comprises 2 pills per day.~     Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per~     day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP)~     of high potency, higher genetic barrier to resistance, with a very good safety profile. The~     objective of this study is to evaluate the virologic safety (maintenance of virologic~     suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults~     with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory~     safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK)~     assessment will be performed in all patients in the first weeks after switch and 24-hours PK~     in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching~     to ABC/3TC/DTG.~   "
75604|NCT02067741|"~     SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal~     CR1447 (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and~     TN-ARpos metastatic or locally advanced breast cancer.~      The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good~     safety and tolerability profile and combines two mechanisms of action, interaction with the~     AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism~     and might offer the possibility of non-chemotherapy based endocrine therapy to the limited~     treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage~     to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect.~      In Phase II the main objective is to assess activity and to determine the efficacy and~     tolerability of CR1447. Phase II will consist of two strata, into which patients will be~     stratified according to their hormonal receptor status: Stratum A for patients with~     endocrine responsive-HER2neg disease, regardless of their AR status and Stratum B for~     patients with triple-negative and determined ARpos disease. Patients with triple-negative~     disease tested negative for AR will be excluded from the trial.~      In both strata patients will be treated with 400 mg of CR1447 until disease progression,~     patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic~     lesion in those patients who gave informed consent will be performed at baseline and within~     the third week of treatment with CR1447.~      Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR,~     angiogenesis and other translational studies as described in this protocol should help~     confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy~     of topical application, tolerability and in deciding whether one should proceed to a large~     randomized trial.~   "
75605|NCT02067728|"~     The main aim of the study would be to examine the effect of using a health behavior~     screening tool and a brief patient centered conversation on health behavior goal setting~     during well-child visits.~   "
75606|NCT02067715|"~     Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth~     sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique~     reduce the tooth sensitivity when compared to conventional technique, without alters the~     bleaching efficacy.~   "
75607|NCT02067702|"~     Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will~     examine the effects of non-pharmacological limb cooling on clinical and physiological~     characteristics in patients presenting with ET at three different temperatures; and will~     measure changes in tremor amplitude after cooling of the upper limb.~   "
75608|NCT02067689|"~     This study will evaluate the influence of non-invasive brain stimulation on different~     elements of cognitive function in healthy persons between the ages of 18-90 years. It will~     specifically use transcranial direct current stimulation (tDCS) to evaluate the relationship~     between certain brain structures and cognitive abilities, like attention, working memory,~     visual search, etc.~   "
75609|NCT02067676|"~     The purpose of this study is to assess the safety of increasing doses of a potential vaccine~     against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This~     study will also assess immune responses induced by the vaccine.~   "
75610|NCT02067663|"~     The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form~     of contraception. The postpartum period is an important moment for contraceptive~     intervention; however there are many barriers to women obtaining birth control postpartum.~     The use of the IUD in the immediate postpartum setting offers many advantages and is~     considered safe, but the risk of expulsion appears to be higher than with interval~     insertion. Previous studies have shown the rate of expulsion of the copper IUD in the~     postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the~     levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12~     months. While studies related to the copper IUD use ring forceps or the operator's hand for~     placement of the IUD, the only published study investigating immediate postplacental~     levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The~     investigators therefore ask the question, is there a difference in expulsion rates between~     levonorgestrel and copper IUDs placed post-placentally when all providers undergo a~     standardized training, use a standardized insertion technique, and when patient level~     characteristics are controlled by randomization?~      The investigators propose to perform a prospective cohort trial comparing the rates of~     expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in~     the uterus within 10 minutes of the delivery of the placenta, using a standardized technique~     (placement with a ring forceps or the operator's hand) after all providers undergo a formal~     didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD~     has a higher rate of expulsion as compared to the copper IUD. Additional objectives include~     a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized~     expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the~     investigators will document the natural history of the location of the IUD within the uterus~     when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks,~     and 3 months postpartum, to better understand the relationship between position of the IUD~     and subsequent expulsion.~   "
75611|NCT02067650|"~     Hardly any imaging studies specifically addressing the articular and periarticular~     structures in MPS patients are available at this point. The investigators propose to do for~     the first time a pilot study using musculoskeletal ultrasound in patients with various types~     of MPS.~   "
75612|NCT02067637|"~     Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer~     therapy on young, reproductively aged cancer survivors. The investigators objective is to~     characterize some of these effects in the cancer population.~   "
75613|NCT02067624|"~     The purpose of this study was to investigate the effect of Thai massage on pressure pain~     threshold, pain intensity, wrist range of motion, grip strength and patient satisfaction in~     patients with wrist extensor muscles latent Myofascial trigger points.~   "
75614|NCT02067611|"~     This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled,~     parallel group, proof of concept, and dose range finding study to evaluate the efficacy,~     safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate~     OA of the knee.~      Objectives of the study:~        1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in~          subjects with osteoarthritis (OA) of the knee;~        2. To assess the safety and tolerability of multiple doses of X0002 when administered as a~          topical spray.~   "
75615|NCT02067598|"~     The purpose of this study is to determine the effect of scapular exercise on pain related~     parameters including pain intensity, 24 hours pain intensity, pressure pain threshold,~     anxiety and muscle tension in patients with scapulocostal syndrome.~   "
75625|NCT02067468|"~     Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human~     papillomavirus (HPV) infection. These abnormalities have been historically detected by~     cervical cytology, but recent evidence shows that HPV testing is superior to cytology to~     detect cervical lesions that eventually will progress to cancer. Despite evidence,~     conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is~     recommended as a triage test for women with atypical squamous cells of undetermined~     significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+~     but higher than healthy population, and therefore it is important to provide appropriate~     clinical management. However, there is no consensus of how to deal women with ASC-US and~     therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2)~     repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of~     this study is to compare the effectiveness and the efficient among the strategies as well as~     to evaluate the acceptability of the HPV testing in a real-life setting.~   "
75616|NCT02067585|"~     Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2~     diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2~     diabetics are obese. Type 2 diabetes resolves post-operatively in 84-98% after bypass and~     48-68% after restrictive procedures.~      Obesity leads to elevated plasma free fatty acids and subsequently to excessive accumulation~     of triglyceride in peripheral tissues, which is an independent risk factor for insulin~     resistance and type 2 diabetes. Bariatric surgery is associated with dramatic decrease in~     plasma free fatty acids and other lipids.~      This study will clarify the relationship of changes in fatty acid and other lipid metabolism~     to improved insulin sensitivity after different bariatric procedures ('restrictive' -~     laparoscopic adjustable gastric band and 'hybrid' - laparoscopic roux-en-y gastric bypass)~     and compare them with non-surgical obese patients. This will allow the investigators to~     refine indications for these procedures especially in patients with type 2 diabetes.~      The investigators will analyze whether surgical bypass of the upper small bowel plays a~     critical role in the resolution of type 2 diabetes and improvement in lipid metabolism. The~     investigators will achieve this by comparing gastric banding and gastric bypass in a~     collaborative research study involving obesity surgeons, physicians and lipid researchers.~   "
75617|NCT02067572|"~     This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining~     good oral health among patients in palliative care. It is hypothesized that using the~     mouthwash made from salvia will result in better oral health and more oral comfort than~     using with conventional normal saline mouthwash.~   "
75618|NCT02067559|"~     The main objective of the study is to test the feasibility of the ICU diaries intervention~     in the ICU. The investigators do not have sufficient power to detect differences in the~     hypotheses below, but will use the present pilot study to inform sample size required to~     adequately power a follow-up randomized control trial.~      (1) The investigators hypothesize that subjects exposed to a psychoeducation condition will~     have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing~     treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in~     the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those~     exposed to both ICU diary + psychoeducation conditions, will have significantly reduced~     rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to~     the ICU diary + psychoeducation condition will have significantly lower rates of PTSD~     compared to those in the ICU diary alone condition.~   "
75619|NCT02067546|"~     Emptying disorders are of the most common causes of constipation. An adjustable toilet seat~     was designed by  Shva-Nach Ltd company, and is designed to facilitate the angle sitting~     position.~      Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from~     constipation and meet the Rome 3 criteria for constipation.~   "
75620|NCT02067533|"~     The purpose of the present study is to determine the influence of position of soft tissue~     repair (flexion versus extension) in post operative range of motion(ROM) and functional~     outcome in patients who underwent primary total knee arthroplasty (TKA).~   "
75621|NCT02067520|"~     Introduction:~      Cesarean section (C/S) is usually performed under spinal with preservative free morphine for~     pain relief, but the investigators have a severe shortage of this formulation of morphine.~     Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has~     been used in spinals for postoperative pain relief and in pain pumps for relief of chronic~     pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for~     post C/S pain.~      Methods:~      This is a randomized double-blind controlled trial utilizing the up-down sequential~     allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief~     following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our~     first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be~     evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and~     morphine use per hour will be recorded. Success will be a median morphine usage of less than~     or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given~     10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end~     after 5 successes.~      Objective:~      The primary objective is to find the optimal dose of IT hydromorphone for pain relief~     following C/S. The secondary objectives are to define the incidence and severity of~     hydromorphone's side effects and determine the duration of analgesia.~   "
75622|NCT02067507|"~     The primary aim of the project is to increase human papillomavirus (HPV) vaccine receipt~     rates among low-income, ethnic minority adolescents (girls and boys 11-17 years of age) in~     Los Angeles County. We will accomplish this goal by implementing and rigorously evaluating~     interventions in multiple venues that serve our target population, including the Los Angeles~     County Department of Public Health (LACDPH) and two large Federally Qualified Health Centers~     (FQHCs).~      Our hypotheses are:~      Primary hypothesis:~        1. The intervention group will have a higher rate of HPV vaccine initiation at follow-up~          compared to the control group.~           Secondary hypothesis:~        2. The intervention group will have higher vaccine completion rates (3 doses) at follow-up~          compared to the control group.~   "
75623|NCT02067494|"~     The purpose of this current randomized clinical trial is to determine the effects of~     myofascial soft tissue release and kinesio taping on disability, pain, quality of life,~     autonomic nervous system and oxidative stress indicators in chronic low back pain.~   "
75624|NCT02067481|"~     This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and~     cardiorespiratory fitness after a diet and physical activity intervention in breast cancer~     survivors and to asses possible relation between these changes.~   "
75637|NCT02067312|"~     The purpose of this study is to determine the effect of Thai massage on pain related~     parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold,~     anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and~     side effect in patients with chronic upper back pain associated with myofascial trigger~     points~   "
75638|NCT02067299|"~     The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to~     persistent sleep) in participants with major depressive disorder who are stably treated with~     selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who~     suffer from insomnia (inability to fall asleep).~   "
75626|NCT02067455|"~     Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths,~     1% of public health expenditure each year in France. Heart transplantation remains the~     standard of care in patients for which medical therapy is not sufficient. But heart~     transplantation is a limited resource, as a result of donor shortages. It is therefore~     possible to consider mechanical circulatory support for patients awaiting heart~     transplantation or for those who are not suitable for transplantation. Left Ventricular~     Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide~     appropriate cardiac output. in this type of device, right heart is not assisted and must~     work on its own, LVADs are thus implanted in patients whose right ventricular function is~     normal.~      The aim of the REVADE study is to assess right ventricular echocardiographic parameters in~     this population, especially on physical exercise, for a better understanding of right~     ventricular adaptation to this long-term modified pressure pattern.~   "
75627|NCT02067442|"~     Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores~     when given preoperatively. This study investigates if there is a difference between the~     intravenous and the oral forms when given preoperatively to patients undergoing lumbar~     microdiscectomy. We hypothesize that the intravenous formulation does not improve pain~     scores or decrease opioid consumption during the first postoperative day compared to the~     oral formulation.~   "
75628|NCT02067429|"~     This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI)~     in correcting astigmatism in patient undergoing standard cataract surgery.~      Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical.~     Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual~     blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have~     astigmatism which is likely to have been corrected by spectacles.~      Cataract surgery involves the replacement of the natural opacifying crystalline lens with a~     clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct~     the patient's glasses prescription. The most widely used IOLs only correct glasses at one~     distance i.e. either near or distance. Residual astigmatism after cataract surgery will need~     glasses for correction which is undesirable for many patients.~      Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear~     window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and~     have no additional risk of complications.~      Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have~     been available for routine use in the last few years; technology has markedly improved and~     the lenses have become cheaper.~      Studies have suggested toric IOLs provide better vision after cataract surgery than the~     regular IOLs. Toric IOL are widely used in the private practice and increasingly in the~     National Health Service (NHS). LRIs are cost effective for treating astigmatism however~     their predictability is believed to be lower than toric IOLs. As there are no randomised~     controlled trials comparing the outcomes between LRIs and toric IOLs. This research will~     address this gap in knowledge and accordingly from this research future practice will be~     able to provide treatment to patients with information about the best outcomes.~   "
75629|NCT02067416|"~     Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to~     determine whom would benefit from chemotherapy prior to surgery. Also could be used as a~     clinical marker to identify patients with breast cancer who do not benefit from some~     preoperative chemotherapies.~   "
75630|NCT02067403|"~     Pressure support (PS) is a commonly used mode of ventilation which is triggered based upon~     the patient's own inspiratory efforts. For the most part, pressure support is well tolerated~     by patients. However, because the trigger for pressure support is an inspiratory effort by~     the patient, and because the resulting support is constant, the ventilator response can be~     out of sync with the patient's needs. The problem of patient-ventilator asynchrony has~     been documented to be large in approximately one quarter of patients who require mechanical~     ventilation. Asynchrony is associated with increased or abnormal work of breathing (WOB) and~     prolonged duration of mechanical ventilation. Diagnosing asynchrony at the bedside can be~     challenging. Electrical activation of the diaphragm (Eadi) recording can provide clinicians~     with a more accurate picture of patient-ventilator synchrony and may thus result in~     decreased asynchrony and decreased or normalized work of breathing for the patient. The~     purpose of this physiologic study is to evaluate the role of protocolized pressure support~     ventilation (based upon Eadi) in comparison to standard pressure support ventilation.~   "
75631|NCT02067390|"~     Acute renal injury is a common complication of critical illness. Drug induced renal insult~     compounds the degree of injury in many patients, and a great deal of research has focused on~     prevention of this complication. Traditional biomarkers of renal injury like serum~     creatinine and blood urea nitrogen content fail to consistently predict harm among patients~     at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.~   "
75632|NCT02067377|"~     This study will evaluate the use of a medical food, oral serum-derived bovine~     immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia~     (a wasting syndrome) improve their nutritional status and gain weight. The medical food is~     in powder form and is mixed with a liquid such as water or orange juice and consumed by~     swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the~     nutritional status of cachexic patients with advanced stages of COPD.~   "
75633|NCT02067364|"~     An exploratory Fit & Function study of Continuous Real Time (CRT) ShuntCheck, a~     non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in~     hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins~     Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize~     device design.~   "
75634|NCT02067351|"~     There is evidence that mindfulness-based interventions (MBIs) such as meditation,~     mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and~     reduce stress in breast cancer survivors. These interventions are becoming increasingly~     popular in cancer survivors. However, little is known about the feasibility and effect of~     MBIs administered during the interval of time of chemotherapy, on QOL and stress. The~     investigators are planning a MBI intervention study developed specifically for breast cancer~     survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for~     at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving~     chemotherapy for breast cancer.~   "
75635|NCT02067338|"~     The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in~     postoperative pain control after posterior lumbar spinal surgery: a randomized,~     double-blind, placebo-controlled study~   "
75636|NCT02067325|"~     The purpose of this study is to determine the effect of Thai massage on electromyogram in~     patients with chronic upper back pain associated with myofascial trigger points.~   "
77310|NCT02045433|"~     The purpose of this study is to determine whether SABR boost therapy is effective in women~     with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI)~     or genitourinary (GU) toxicity.~   "
75645|NCT02067208|"~     Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these~     insoles typically reduce knee abduction moments (KAM) - a variable associated with knee~     osteoarthritis - and thus are believed to be beneficial for OA management, recent research~     has indicated that in some cases lateral wedge insoles actually increase knee joint loads.~     In such cases, a medial wedge may be more appropriate.~      The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months~     for patients with knee OA. It is hypothesized that pain reduction will be directly related~     to KAM reduction.~      Forty-six participants with knee OA will be recruited to participate. Each will undergo~     biomechanical gait analysis to determine the wedge type that most greatly reduces knee~     adduction moments. In addition, each participant will undergo a Dual Energy X-Ray~     Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a~     series of questionnaires to evaluate pain, function, physical activity, footwear comfort and~     injury history. Participants will be randomized into either a wait list control group (no~     insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months.~      Changes to pain, function, comfort and physical activity from baseline to 3 months will be~     assessed within the control and experimental groups. Regression analyses will be conducted~     on the experimental group to determine if a relationship exists between reduced KAMs and~     reduced pain over 3 months. Comparisons will also be made between the control and~     experimental groups.~   "
75646|NCT02067195|"~     To compare the efficacy of 2 different hydration strategies, hydration according to clinical~     guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI~     undergoing primary PCI to investigate the possible beneficial role of periprocedural~     adequate hydration.~   "
75647|NCT02067182|"~     Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of~     atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of~     OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF~     (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful~     ablation in these patients remains to some extent un-clear. As OAC bears the risk of~     bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the~     incidence of silent cerebral embolic events in patients with a high risk for embolic events,~     free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that~     continued administration of dabigatran is superior in the preven-tion of silent cerebral~     embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic~     AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for~     paroxysmal AF.~   "
75648|NCT02067169|"~     Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5%~     of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol~     studies. This prevalence vary with the organ transplanted and the degree of viral~     replication and immunosuppression. Less data are available to date from real-life cohorts of~     patients, and there is no systematic survey of resistance in Europe or in the US. Non~     response to treatment concerns a larger group of patients and can result either from~     emergence of a resistant strain (virological resistance), from inadequate dosage of~     antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The~     respective clinical impact of virological resistance and clinical resistance (of~     pharmacological or immunological origin) on graft outcome and long-term survival of patients~     has never been assessed. High viral loads and persistent replication associated to prolonged~     exposure to antivirals are known to favor the emergence of resistant strains. Though~     epidemiology of resistant strains, role of multiple infections, impact of various mutations~     on degree of resistance to antivirals and outcome remains to be further studied. Most~     studies are per-protocol studies or short-term studies conducted on limited populations.~     There are no data in real-life of transplanted patients at the era of enlarged prophylaxis~     except those from the French survey for cytomegalovirus resistance cohort opened at the end~     of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of~     non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on~     214 patients) with a trend to poorer outcome in case of virological resistance and to the~     absence of impact of prophylaxis versus preemptive therapy, though larger populations and~     prolonged follow-up are requested to fulfill all objectives.~      We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large~     number of patients and a prolonged follow-up, to gather data on resistance to antivirals in~     real-life of transplant patients in an organized data bank, This cohort is in the continuum~     of our previous cohort started in 2006, granted by the Hospital Clinical Research Program~     Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.~   "
75649|NCT02067156|"~     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over~     50% of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical~     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to~     improve second-line therapy in GBM have met with only marginal success and there is a large~     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug~     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,~     but not by normal cells or blood vessels in normal tissue. It is believed that activation of~     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the~     activity, safety and CNS exposure of G-202 in patients with recurrent or progressive GMB~     receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle. Funding~     Source - FDA OOPD~   "
75650|NCT02067143|"~     This study will be conducted in different centres and will study adult patients with~     Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study~     treatment will include a induction/consolidation therapy incorporating pegylated~     Asparaginase (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic~     drugs, for the achievement of an early negative minimal residual disease (MRD) status. The~     MRD study supports a risk/MRD-oriented final consolidation phase.~   "
75658|NCT02067039|"~     This study seeks to determine the public health impact of providing rapid HIV test kits to~     men who have sex with men (MSM) so they may test themselves at their convenience. The study~     will determine if men who receive the rapid HIV test kits report HIV testing at least three~     times per year. This study will be conducted in four consecutive parts. The first three~     parts are formative in nature to guide the development and implementation of Part 4 of the~     study. The research study will use two different types of rapid HIV tests. The OraQuick®~     In-Home HIV Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay,~     currently FDA-approved for professional use and distributed in the U.S. as Clearview®~     Complete HIV-1/2 Rapid Test. An Investigational Device Exemption will be obtained from the~     FDA to allow the contractor to supply the Sure Check® HIV 1/2 Assay to study participants~     since it is not approved for home use.~   "
75659|NCT02067026|"~     Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic~     risk profiles and gut microbiota in subjects with high BMI~      Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food~     supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary~     metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile~     acid and fecal sterol concentrations.~      Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation~     modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total~     cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin~     levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of~     intestinal permeability in plasma; (8) inflammation~      Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for~     Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health.~      Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled~     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long~     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic~     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy,~     tobacco smoking.~      Methodology After a run-in phase of two weeks, participants will be randomized to receive~     supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4~     weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be~     performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S.~     di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and~     stool and urine collection will be performed during visits at the beginning and end of each~     treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento.~     A 4 day-food diary record will be collected before visits T0 and T1.~      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food~     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL~     cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14,~     LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal~     microbiota analysis.~      Safety Assessments. Adverse events.~      Statistical analyses. Post-intervention data will be compared by ANOVA using the General~     Linear Model with baseline as a covariate. Data with a skewed distribution will be log~     transformed before analyses. Simple and multiple linear regression will be used to determine~     relationships between variables and independent t-tests performed to evaluate differences in~     reported compliance between groups. Results will be expressed as mean +/- SEM and~     differences will be considered significant at P < 0.05..~      Duration of Dosing. Subjects will make three visits during the study (start of run-in phase~     - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week~     6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is~     targeted.~   "
75689|NCT02066610|"~     The objectives of the study were to assess the serum selenium, zinc, and copper status and~     plasma and white blood cell antioxidant enzyme activities of low birth weight infants~     receiving selenium supplemented and non-selenium supplemented parenteral nutrition from~     initiation of parenteral nutrition until discontinuation of preterm formula or hospital~     discharge.~   "
75651|NCT02067130|"~     In patients with hereditary anemias (e.g. thalassemias), defective red blood cells are~     produced due to an error in the genes, or DNA, that provide the instructions for their~     synthesis. As a result, hereditary anemias are characterized by chronically low hemoglobin,~     which is contained inside red blood cells and carries oxygen throughout the body. In more~     severe cases, patients are dependent on frequent blood transfusions to replenish the~     hemoglobin.~      The body has limited ability to get rid of excess iron. However, with repeated blood~     transfusions, the iron level in the body builds up because the red blood cells contain iron~     as heme. Over time, the high level of iron accumulates in organs such as the heart, liver,~     and pancreas causing heart problems, liver failure, and diabetes. As a result, patients who~     receive multiple blood transfusions need to be monitored for iron overload, and be started~     on medical therapy in a timely fashion to prevent organ damage.~      Liver is usually the first and the most affected organ by iron accumulation, so knowledge of~     its iron concentration provides estimate of total body iron load. Liver biopsy is the gold~     standard in measuring the iron concentration in the liver, but it is invasive and cannot be~     performed on routine basis. MRI is another option that can assess liver iron concentration~     non-invasively, and is currently recommended for monitoring iron load on a yearly basis.~     However, MRI has a high cost and is not easily accessible in Canada. The investigators aim~     to determine if transient elastography (Fibroscan), which is a form of ultrasound that~     measures liver stiffness, can accurately assess liver iron concentration.~      Hypothesis:~      Fibroscan reading correlates with MRI and serum ferritin in estimating hepatic iron~     concentration.~   "
75652|NCT02067117|"~     This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC~     FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot~   "
75653|NCT02067104|"~     This study is a single site double blinded Phase II study to evaluate the chemopreventative~     effectiveness of vismodegib in the treatment of subjects at high risk for developing basal~     cell carcinomas (BCC).~   "
75654|NCT02067091|"~     Patients presenting with acute ST elevation myocardial infarct urgently need~     revascularization. Standard of care is establishing bloodflow through the coronary vessels~     using thrombus aspiration catheter, and securing the result by using a metallic drug eluting~     stent. New kinds of non-metallic bioresorbable stents are now available. They have however~     challenges in structural strength.~      The investigators want to compare the new bioresorbable scaffold with traditional metallic~     stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120~     patients. The investigators will use an imaging technique, optical coherence tomography, to~     evaluate the results after 12 months.~      The investigators also want to see if modern multislice computed tomography can give useful~     information in the follow-up of stented coronary arteries after 12 and 24 months.~   "
75655|NCT02067078|"~     Purpose:~      The purpose of this study is to evaluate the postoperative analgesic effect of a combined~     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the~     tissue around the knee after surgery with knee replacement. In the combined nerve blocks we~     use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone (protracted mixture)~     and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is~     that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain~     and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and~     lethargy compared to the current treatment with local infiltration analgesia.~      Background:~      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven~     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the~     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous~     nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve~     block causes both stunning of the sensory nerves to the knee region and the thighs inward~     leading muscles, and does not affect the patient's mobilization capacity.~      Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a~     well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in~     other studies, in addition to the local anesthetic agent, and has been shown to prolong the~     effect of the nerve block. Saphenous and Obturator nerve block with all four drugs~     Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically~     investigated in knee replacement surgery, and it is not known whether this method will~     provide better pain treatment.~      Method~      The patient can receive one of three treatments, determined randomly:~        -  A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine,~          Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with~          placebo medicine (normal saline).~        -  B. Saphenous block with active anesthetics and both Obturator nerve block and local~          block around the knee joint with placebo medicine (normal saline).~        -  C. Both block with placebo medicine (normal saline) and local block around the knee~          joint with effective local anesthetic.~      Neither patient, investigator or staff around the patient will have knowledge of which~     treatment the patient has received.~      The blocks will be injected before the operation and local infiltration around the knee~     joint will be given by the surgeon during the operation.~   "
75656|NCT02067065|"~     Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the~     administration of propofol by non-anesthesiologists, despite moderate quality evidence that~     support its' use.~      There is only one small trial of a direct comparison of propofol sedation by~     anesthesiologists versus non-anesthesiologists.~      Our aim is to compare the incidence of sedation related adverse events, the procedural~     quality indicators, times (onset, recovery, discharge) and patient satisfaction between~     non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist~     propofol sedation.~      A randomized clinical trial with the incidence of sedation related minor adverse events as~     primary endpoint will be conducted. Secondary endpoints include procedure quality~     indicators, propofol dosage and patient satisfaction.~      A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90%~     power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events~     incidence, estimated from our pilot experience. The sample size was adjusted for a 2%~     cross-over rate.~      Informed and consenting patients undergoing colonoscopy examinations will be randomly~     assigned to one of two arms. One group will be sedated by an anesthesiologist according to a~     protocol of propofol mono-sedation. The other group will be sedated with propofol boluses,~     according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with~     a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse,~     trained in NAAP and exclusively dedicated to sedation and patient monitoring.~   "
75657|NCT02067052|"~     Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy.~     When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the~     anus, or when it is in the groin lymph nodes, surgery alone is not always able to be~     performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both .~      So far it is not known the best sequence of treatment: surgery, chemotherapy or~     radiotherapy. The radical surgeries usually need long recovery term both in the region of~     the vulva and in the region of the groin lymph nodes. When it is performed, convalescence~     can delay other treatments, like radiotherapy and chemotherapy. On the other hand, the use~     of radiotherapy and chemotherapy as a first step treatment can result in a complete~     elimination of the disease in at least 30% of the cases or substantial reduction of its~     size, allowing less extensive surgery.~      Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of~     vulvar cancer, but in a sequence that has not been studied, in order to increase benefits of~     these treatments, and reduce morbidity.~      This study will be offered to patients who have disease of the vulva less than 4 cm~     (sentinel lymph node), or greater than 4 cm, or illness that compromises urethra and anus,~     or patients with disease in groin lymph nodes (glands).~        1. On the eve of the surgery, investigators will inject dextran-70 labeled with~          technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure.~        2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal~          (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed~          at this time. Patients will be treated with radiation therapy with concomitant~          chemotherapy for approximately six weeks.~        3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform~          a surgery to remove the remaining tumor in the vulva.~   "
75660|NCT02067013|"~     Clinical Retina research studies often collect aqueous samples in hopes of estimating levels~     of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous~     correlate. This study will collect vitreous and aqueous samples at the same time to evaluate~     and compare drug and cytokine levels.~      The overall objective of this study is to evaluate the molecular concentration of growth~     factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from~     individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to~     proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to~     macular degeneration, macular hole or neovascular glaucoma.~   "
75661|NCT02067000|"~     Validation of the patient perception questionnaire relating to CPAP use~   "
75662|NCT02066987|"~     the present study had two main aims. First, due to the current underconsumption of dental~     brush adolescents, the investigators should apply a volitional intervention to increase oral~     health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness~     of action planning intervention and implementation intention will improve oral health~     behavior in adolescents.~   "
75663|NCT02066974|"~     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients~     were presented with advanced disease. Percutaneous ethanol injection, radiofrequency~     ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a~     curative treatment and have achieved very limited success in eradicating large HCC or tumors~     causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique,~     RT can be safely given to patients with larger tumor or portal vein thrombosis. However, RT~     could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of~     studies regarding a quantitative biomarker to predict tumor response or forecast the outcome~     in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers~     for personal medicine because pretreatment AFP is not always useful as a surrogate marker in~     some of the patients.~      The present study is to investigate whether circulating tumor cell genome in peripheral~     blood can be used to predict RT response in HCC. We will use the blood sample from patients~     with locally advanced HCC receiving RT. By using next generation sequencing, We are going to~     explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma.~     By this way, genomic expression in peripheral blood may play a key role in determining the~     optimal therapeutic strategies for HCC patients by predicting tumor response to RT.~   "
75664|NCT02066961|"~     The purpose of this study is to describe patterns in disease management and to describe~     clinical outcomes, as well as to identify factors influencing physician treatment decisions~     including reason(s) for treatment choices and trigger(s) for treatment changes and to~     document healthcare resource utilization used to manage treatment-related complications.~   "
75665|NCT02066948|"~     About two-thirds of adults in the United States are overweight or obese with likely adverse~     health consequences. A Moderate weight loss by dieting and exercise is recommended to~     improve health. We are interested to know whether eating dietary protein at different times~     of the day influences changes in body composition, muscle and indices of health. The purpose~     of this study is to examine the effects of within-day patterning of dietary protein intake~     (even vs. skewed) on energy-restriction and resistance training-induced changes in body~     composition, muscle size, appetite, and clinical health (including blood glucose and blood~     pressure).~   "
75666|NCT02066935|"~     The purpose of this study is identify the prevalence of non-adherence to immunosuppressives~     in Brazilian renal transplant recipients, identify the factors related to non-adherence in~     the studied population and identify the prevalence of non-adherence in the different regions~     of the country.~   "
75667|NCT02066922|"~     The purpose of this study is to compare the change from baseline in central corneal~     curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.~   "
75668|NCT02066909|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in~     healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days~     (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese~     healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the~     safety/tolerability and PK data from the Western and Japanese populations.~   "
75669|NCT02066896|"~     This study was designed to test the efficacy and safety of low laser therapy to treat the~     xerostomia of patients with primary Sjogren's Syndrome.~   "
75670|NCT02066870|"~     The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably~     develop acquired resistance. A great deal of research are focusing on this issue. Arsenic~     trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and~     other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the~     resistance of tumor cells to chemotherapy and TKIs.~   "
75671|NCT02066857|"~     The purpose of this prospective randomized study is to add to the body of knowledge on the~     treatment of minimally displaced distal radius fractures in patients over 60 years of age.~     The investigators believe that treating minimally displaced distal radius fractures in~     people over 60 with a removable splint and early range of motion will provide greater~     patient satisfaction, fewer complications, and earlier functional returns to pre-injury for~     these patients compared to those treated with a short arm cast which immobilizes the limb~     for at least four weeks, and has been shown to lead to longer recovery and possible residual~     stiffness. The investigators hope to provide sufficient evidence in directing treatment that~     will give the most efficacious and the most satisfactory return of prior function to~     patients. Since distal radius fractures in the elderly are common because of poorer bone~     quality, the elderly proportion of the population is increasing, and controlling health~     costs is of current concern, answering the question of which treatment produces the best~     results for all these concerns is of increasing importance now.~   "
75672|NCT02066844|"~     The purpose of this randomized, parallel-group, single-blinded, single center, Phase II~     study is to collect data to compare the comfort and patient satisfaction of a hip injection~     delivered via the Navigator compared to a standard needle injection. In addition, delivery~     preparation will be compared between a Navigator injection and a standard hip injection. The~     data collected from this pilot study will serve as the basis to design a larger multi-center~     study.~   "
75674|NCT02066818|"~     Local anesthesia used for incision and drainage of abscesses is known to be painful.~      We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable~     lidocaine during incision and drainage (I&D) of skin abscesses.~      Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine~     patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and~     following the procedure was similar in both groups.~   "
75675|NCT02066805|"~     This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries~     and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate~     assessment of prescriptions and diagnoses, especially those related to cancer patients~     during the first year post the initial market availability of XGEVA.~   "
75676|NCT02066792|"~     The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison~     to placebo (a pill containing no medication) for improving the effectiveness of~     cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety~     disorder. In addition, the study will examine whether the effectiveness of d-cycloserine~     depends on the timing of the pill administration (i.e., 1- hour before the session or~     immediately after the session) as well as the success of the CBT therapy sessions. The~     investigators hypothesize that the tailored post-session DCS administration condition will~     outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session~     DCS). This will be evidenced by short- and long-term improvements in social anxiety~     severity.~   "
75677|NCT02066766|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Vietnam.~   "
75678|NCT02066753|"~     This PhD study is a sub study in a randomized clinical controlled multicenter trial named~     TTH48 (ClinicalTrials.gov Identifier: NCT01689077).~      The TTH48 trial examines prolonged mild therapeutic hypothermia (MTH) at 32-34°C in 24~     versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in~     comatose out-of-hospital cardiac arrest patients.~      THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE~     HEMODYNAMICS BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF~     INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS~     MTH GROUPS.~   "
75679|NCT02066740|"~     The purpose of this study is to collect acute confirmatory data to evaluate technical~     success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™~     delivery system.~   "
75680|NCT02066727|"~     Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective~     concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of~     bladder tumor~   "
75681|NCT02066714|"~     Hand Foot and Mouth Disease (HFMD) is a common infectious disease in childhood. Several~     enteroviruses are associated with the disease. However, since 1997, large outbreaks of HFMD~     in Taiwan, Malaysia and Vietnam have seen unusual neurological complications such as~     brainstem encephalitis with rare fatal outcomes. The pathogen associated with this severe~     disease is Enterovirus 71.~      In 2011, Vietnam had a large outbreak of Hand Foot and mouth disease resulting in 110,000~     cases and 164 deaths. HFMD affects children during their early years of child development,~     but there is limited information on what the potential long-term consequences are. Small~     studies have suggested language and cognitive difficulties in more severe disease but this~     has not been evaluated in a large cohort.~      Internationally recognized and standardized assessment tools are not available for early~     childhood in Vietnam. This project will translate and adapt the Bayley Scales of Toddler and~     Infant Development 3rd edition (Bayley III) and Movement ABC, 2nd edition (MABC) into~     Vietnamese as outcome measures.~      This study will evaluate whether there are neurodevelopment difficulties following severe~     HFMD. The study design is a prospective observational cohort study. Hospitalised children~     with a clinical diagnosis of HFMD will be eligible to enroll. Written parental consent will~     be required. Participants enrolled will be assessed 3 times over 18 months from discharge~     from hospital into the study. Since there is no standardization of Bayley III or MABC for~     Vietnam, a healthy cohort, age and sex matched to the least severe HFMD participants will be~     recruited. This healthy cohort will follow the same assessment program over 18 months. A~     total of 350 HFMD participants and 150 healthy children (matched to the least severe HFMD~     participants) will be recruited.~   "
75682|NCT02066701|"~     This study is to identify potential markers from esophageal biopsies and brush cytology for~     feasibility of use in stool specimens for detection of Barretts Esophagus.~   "
75683|NCT02066688|"~     Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and~     methylation reactions as well as calcium and vitamin D are assumed to be effective in the~     prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to~     investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.~   "
75684|NCT02066675|"~     Phase II, non-randomized, two-stage study according to Bryant & Day The study enroll~     patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard~     chemotherapy (doxorubicin/epirubicin and/or ifosfamide)~   "
75685|NCT02066662|"~     The following trial hypothesis will be proved: In patients with atrial fibrillation and/ or~     pulmonary embolism standard anticoagulant treatment with coumadin/phenprocoumon is~     associated with accelerated coronary or valvular calcification as assessed by cardiac~     computed tomography compared to the new anticoagulant therapy with rivaroxaban.~   "
75686|NCT02066649|"~     Subjects will be those individuals greater than 18 years of age with a diagnosis of~     cirrhosis undergoing screening for esophageal varices. Eligible subjects will have a~     diagnosis of cirrhosis and esophageal varices (graded as medium or large) with no prior~     history of variceal bleeding. The diagnosis of cirrhosis will be based on clinical,~     radiologic, and/or laboratory data. Patients will be randomly assigned using electronic~     medical records to one of three treatment arms after screening esophagogastroduodenoscopy~     (EGD) has been performed and large varices are identified. Primary outcome of the study will~     be the incidence of variceal bleeding in patients receiving one of the following therapies~     for primary prophylaxis of variceal bleeding: carvedilol, variceal band ligation (VBL), or~     both carvedilol and VBL.~   "
75687|NCT02066636|"~     The purpose of this study is to estimate the incidence and characterize the outcome of high~     grade, select adverse events in subjects with advanced or metastatic NSCLC treated with~     Nivolumab.~   "
75690|NCT02066597|"~     Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one~     of your veins. It affects 5% of the population and is the third most common circulatory~     condition after heart attack and stroke. People who experience a clot in their vein can have~     significant long term problems with swelling and discomfort. The investigators call this~     post thrombotic syndrome (PTS). They can also be at increased risk of having another clot~     occur. People who have ilio-femoral clots are more likely to have more severe leg swelling~     and pain than those who have clots in smaller veins. They are also more likely to have~     problems returning to their normal daily routines and may need more hospital visits.~      The current standard of care involves treating patients with anticoagulants (blood thinners)~     because it has a low risk of bleeding risk and is inexpensive. Blood thinners prevent the~     clot from growing bigger while your own body dissolves the clot over time.~      The type of clot you have is the most severe form of DVT. Some experts advise early removal~     of the clot - resulting in symptom relief sooner and possibly reducing the risk of PTS. This~     is in addition to the standard treatment with blood thinners.~      There are currently two options for physically removing these clots. One method involves~     placing an intravenous catheter into your leg and injecting medication directly where the~     clot is situated. This dissolves the clot. This method is called Catheter Directed~     Thrombolysis (CDT). The second method, Percutaneous Mechanical Thrombectomy (PMT), involves~     placing an intravenous catheter into your leg and breaking down the clot mechanically and~     suctioning it out of the vein - creating good blood flow again to your leg. Both methods~     require injection of contrast dye and a special x-ray machine to see where the clot is and~     ensure that the entire clot is removed.~      CDT is very expensive and has an increased risk of major bleeding. PMT is much less~     expensive and has a lower risk of bleeding. The doctors at The Ottawa Hospital do not~     typically recommend CDT, nor do we commonly perform PMT for this patient population here.~      The investigators would like to enroll 26 participants with ilio-femoral DVTs and perform~     PMT to see if they can achieve better outcomes than for those who have just had our routine~     treatment of blood thinners. The investigators are only conducting this study here at The~     Ottawa Hospital, General Campus. They will follow the progress of participants for 6 months.~     The device the investigators are using (Angiojet Ultra Thrombectomy System) is already~     approved by Health Canada for this procedure.~   "
75691|NCT02066584|"~     The importance of glucose in culture media on fertilization and embryo development is still~     controversial. Although it has been reported that glucose is essential for fertilization~     process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of~     glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim~     of this retrospective study is to examine whether exposure of sibling oocytes to different~     concentrations of glucose in culture media has any further effect on IVF outcome.~   "
75692|NCT02066571|"~     Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's~     disease patients, this is to confirm and further investigate the safety and efficacy using a~     similar dose. The possible beneficial effects on cognition in mildly cognitively impaired~     Parkinson's disease patients will also be tested, since this problem in Parkinson's disease~     may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter~     associated with multiple brain functions).~      During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and~     freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a~     computer-based program.~   "
75693|NCT02066558|"~     In this study the investigators will research the hypothesis that the gas carbon monoxide~     induces headache and increases the blood flow velocity in the middle cerebral artery.~   "
75694|NCT02066545|"~     The primary objective of this study is to evaluate the safety and efficacy of once-daily~     topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel~     in subjects with inflammatory acne vulgaris~   "
75695|NCT02066532|"~     The purpose of this study is to examine the safety and efficacy of Ruxolitinib in~     combination with Trastuzumab in treatment of HER2 positive metastatic breast cancer.~     Ruxolitinib (Jakafi) is an Food and Drug Administration (FDA) approved treatment for~     myelofibrosis (a disease of the bone marrow), but its safety and efficacy in breast cancer~     patients is not known. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2~     positive breast cancer. The safety and efficacy of both treatments given in combination is~     not known. It is hypothesized that Ruxolitinib in combination with Trastuzumab will~     demonstrate efficacy in treating Metastatic HER2 Positive Breast Cancer subjects, and will~     have a tolerable safety profile in this patient population.~   "
75696|NCT02066519|"~     The purpose of this study is to demonstrate that a 3 months physical exercise programme~     improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized~     since at least 6 months under prednisone and/or azathioprine.~   "
75697|NCT02066506|"~     the first purpose of the study is to determine the adaptative mechanisms of right ventricle~     (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital~     heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The~     mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second~     objectives are to evaluate these mechanisms using echography, arterial properties study and~     neurohormonal levels~   "
75698|NCT02066493|"~     The purpose of this study is to generate detailed insight into which therapies of giant~     intracranial aneurysms are being conducted, to document the natural history and the outcome~     of treatment over 5 years after inclusion into the Registry and to follow imaging data of~     giant aneurysms over years after diagnosis.~   "
75699|NCT02066480|"~     Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and~     deterioration of bone microarchitecture , leading to increased fracture risk for low trauma,~     such as spinal fractures or femoral neck .~      It is estimated that 3 million people are living in France , particularly women , with an~     incidence that increases with age .~      This disease is a major public health issue in terms of morbidity and mortality , costs and~     risk of recurrence (after a first fracture episode) , including risk factors are identified.~      However, although bone densitometry is a reliable diagnostic tool and preventive treatments~     are at our disposal, screening for osteoporosis is still insufficient .~      The objective of our study is to improve the detection of osteoporosis in Hospital~     Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone~     densitometry or if risk factors are found. Based on the results , the patient will be sent~     in rheumatology consultation for implementation of treatment if necessary .~      Therefore included women hospitalized in medical services , gynecology, surgery and~     orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women~     who could answer a simple questionnaire and those previously treated for osteoporosis or~     have already received a bone density there is less than 3 years old .~   "
75754|NCT02065739|"~     The purpose of this study is to assess the effects of repeated administration of 200 mg of~     itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male~     participants.~   "
77366|NCT02044705|"~     The purpose of this study is to evaluate the impact of the 10-week Active and Healthy~     Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.~   "
75700|NCT02066467|"~     The objective of this study is to collect clinical data on safety and performance of ACUITY~     X4® leads when used in a standard clinical setting.~      It is a prospective, non-randomized, observational multicenter study evaluating standard of~     care.~      For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse~     events and basic parameters of the lead will be assessed. The cohort of subjects included in~     this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to~     receive an ACUITY X4® lead implant.~      Study endpoints:~      Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate~     of freedom from loss of function or operative system revision due to unacceptable PNS~     threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months~     post-implant.~   "
75701|NCT02066454|"~     To evaluate:~        -  the incidence of venous thromboembolic event (VTE)~        -  the incidence of hemorrhagic complications, In a population of patients with myeloma~          who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral~          anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day~   "
75702|NCT02066441|"~     The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly~     individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D~     level, bone formation, resorption, and mineral density, flexibility, balance, general~     inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the~     continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders~     thought to now be related to low levels of vitamin D, which are some of the leading~     disablers and killers of Americans. Americans also have difficulties with compliance to~     prescription medications due to their toxicity and side effects. This study aims to learn~     more about how a vitamin D nutritional supplement may improve nutritional status and enable~     the body to normalize system functioning,which may improve the quality of life for people~     with vitamin D deficiency. The results of this research will be used to determine if vitamin~     D is beneficial for overall health among elderly individuals.~   "
75703|NCT02066428|"~     Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range~     finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile~     females.~   "
75704|NCT02066415|"~     To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly~     migraine days~   "
75705|NCT02066402|"~     This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra~     venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily~     I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection~     (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all~     subjects.~   "
75706|NCT02066389|"~     This is a randomized, double-blind, parallel-group, placebo controlled, multicenter study to~     assess the safety and efficacy of ABT-494 in subjects with active rheumatoid arthritis who~     have failed Methotrexate alone.~   "
75707|NCT02066363|"~     Clinical background: Weight loss is a common problem in patients suffering from~     gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with~     weight loss is worse than that for weight stable patients. Malnutrition in cancer patients~     is associated with a poor prognosis and is an important predictor of mortality.~     Supplementation with home parenteral nutrition in aphagic and terminal patients has shown~     improved quality of life, energy balance, body composition and prolonged survival.~      Aim: The aim of this study is primarily to study the effects of supplementation with~     parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean~     body-mass and body composition. Patients found to be at nutritional risk will be included in~     the study and will be randomized to either best supportive nutritional care or best~     supportive nutritional care and supplemental Parenteral Nutrition.~      Design: This study is a controlled, randomized trial with two parallel study arms. The study~     will include patients with advanced GI cancers at nutritional risk, performance status 0-2~     and with an expected survival of a minimum of 3 months.~      A total of 100 patients are planned to be enrolled and randomized to either best supportive~     nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.~      Primary endpoint is improvement of lean body mass, and by that improvement of quality of~     life, performance status and cancer treatment tolerance.~      Discussion: The planned study will provide important information about the effect of~     parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative~     treatment strategies are set up to improve quality of life as well as prolongation of life.~     Parenteral nutrition in this patient group may indeed contribute to both these aspects of~     palliation.~   "
75708|NCT02066350|"~     Patients accepted for the waiting list for single pancreas transplantation suffer from~     severe glucose instability with hyperglycemia due to diabetes type 1, but do not have~     significant diabetes-related complications. Pancreas transplantation restores normoglycemia~     in diabetes type 1 patients with unstable control of glycemia. Both hypo- and hyperglycemic~     events are abolished, and 70-80 % of the patients obtain satisfactory HbA1c levels (HbA1c~     5.0-6.0 %) without the need of exogenous insulin. Endothelial dysfunction is considered as~     an early and potentially reversible stage in the atherosclerotic process. The endothelium is~     involved in homeostasis, leucocyte adhesion and vasomotor activity. Reduced~     endothelium-dependent vasodilation is associated with increments in cardiovascular risk~     factors, and endothelial dysfunction is a predictor for future cardiovascular disease. It~     has also been hypothesized that endothelial dysfunction may be involved in the impaired~     glycemic control by reducing the availability of glucose in peripheral muscles.Establishing~     normoglycemia by pancreas transplantation alone in previously diabetic type 1 patients has~     recently been shown to improve left ventricular ejection fraction, assessed by Doppler~     echocardiographic examination. In diabetic patients receiving a new pancreas it is possible~     to assess the effect of changing blood glucose excursions on cardiovascular risk factors,~     including endothelial function, without the use of antidiabetic drugs (exclude pleiotropic~     effects).~      The primary objective of the present study is to assess if endothelial function (assessed by~     flow-mediated dilatation of arteria brachialis) is improved when hyperglycemia is reversed~     by single pancreas transplantation in patients with type 1 diabetes.~      Secondary objectives are to investigate the changes in the following parameters by reversal~     of hyperglycemia by pancreas transplantation; Peripheral arterial tonometry, serum/plasma~     concentrations of endothelial dysfunction markers, blood pressure, lipid and lipoprotein~     concentrations.~   "
75709|NCT02066337|"~     To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional~     periodontal therapy on selected clinical parameters as well as alveolar bone density (BD)~     and superoxide dismutase (SOD) activity in patient with chronic periodontitis.~   "
75710|NCT02066324|"~     The purpose of this study is to collect urine samples from patients with fibrodysplasia~     ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease~     progression and for prediction of flare-ups of the disease. Disease related biomarkers in~     these patients are currently unknown. This study aims to support the development of novel~     therapy/ies for this disease.~   "
75769|NCT02065544|"~     This is a study of the effects of weight loss and exercise training on glucose control as~     measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes.~     Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months.~     Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of~     inflammation. The study hypothesis is that the program of weight loss and exercise will put~     >50% of individuals into remission of their type 2 Diabetes as measured by a HBA1c of <~     6.5%.~   "
77367|NCT02044692|"~     The objective of this study is to evaluate the long term safety and efficacy of once weekly~     dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis~     II) Patients~   "
75711|NCT02066311|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's~     immune system attacks different parts of the body. SLE is characterized by inflammation that~     leads to tissue damage in different organ systems. Any organ system may be involved,~     including the skin, the joints, the kidneys, the nervous system, the heart, the lungs, and~     the blood. The exact cause of SLE is not known. Patients with SLE often have elevated levels~     of anti-double stranded DNA antibodies. These levels are often associated with disease~     flares and disease severity. These antibodies can bind to tissue leading to organ damage.~     Preventing these antibodies from binding to their targets may help decrease disease~     activity.~      Protease inhibitors are medications that have been approved by the Food and Drug~     Administration (FDA) for use in the treatment of HIV (human immunodeficiency virus).~     Nelfinavir (also called viracept) is one of these protease inhibitors. Separate from their~     anti-viral effects, protease inhibitors have been found to decrease inflammation. These~     medications have been shown to interfere with binding of anti-double stranded DNA antibodies~     to their targets and may decrease inflammation in SLE. This research study tests whether the~     protease inhibitor, nelfinavir, will decrease anti-double stranded DNA antibody binding and~     decrease disease activity.~   "
75712|NCT02066298|"~     Because approximately half of all mild-moderately-severe asthma is persistently~     non-eosinophilic, it is important to determine prospectively if patients who are~     persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment~     compared to patients who are not persistently non-eosinophilic.~   "
75713|NCT02066285|"~     Phase II, open-label, non-randomized, international multicenter clinical trial with two~     strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients~     will receive oral pazopanib at 800 mg once daily continuously. Patients will continue to~     receive treatment until there is evidence of progressive disease, unacceptable toxicity,~     non-compliance, withdrawn consent or investigator decision. The main goal is to determine~     the objective response rate (ORR) (confirmed complete response [CR] and partial response~     [PR]) in patients with unresectable, locally advanced or metastatic solitary fibrous tumor~     and extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.~   "
75714|NCT02066272|"~     Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of~     Inflammatory bowel disease. Their common features include high efficacy but also~     immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the~     first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to~     be established.~      This prospective, multicenter, observational cohort study will assess safety of treatment of~     anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.~      Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease,~     ulcerative colitis or indeterminate colitis between January 1st, 2014 and December 31st,~     2015. Data to be collected include demography, Montreal classification, indication to~     treatment, previous treatment, operations, extraintestinal manifestations and concomitant~     diseases. Data on response, tolerability and safety of anti-TNF and on concomitant treatment~     will be collected. Adverse events logs will be completed. Majority of IBD centres in Poland,~     pediatric and adult, academic and regional, have agreed to participate in the study.~      As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients~     on various anti-TNFs will be established.~   "
75715|NCT02066259|"~     The OctavaColon tests are qualitative plasma tests that are indicated to people above 18~     years of age suspected with colon abnormality. The blood tests will provide additional~     information to the doctor in the course of colon cancer diagnosis for both normal population~     and high risk population~   "
75716|NCT02066246|"~     The aim of our study is to investigate if the use of the AirSeal insufflation system impairs~     the lung function of patients less than a conventional system in patients undergoing~     robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung~     function before and after surgery.~      As a second purpose of the study, in a subgroup, we investigate the influence of the gas~     insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study~     the change in the lung perfusion-ventilation-ratio by using the electric impedance~     tomography technique.~   "
75717|NCT02066233|"~     Will EG Scan (transnasal endoscopy) determine presence of Barrett's Esophagus, esophagitis~     and hiatal hernia as well as standard sedated endoscopy.~   "
75718|NCT02066220|"~     The study PNET 5 MB has been designed for children with medulloblastoma of standard risk~     (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With~     the advent of biological parameters for stratification into clinical medulloblastoma trials,~     the ß-catenin status will be the only criterion according to which study patients will be~     assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The~     initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for~     study entry are the same for both treatment arms.~   "
75719|NCT02066207|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     atorvastatin and fenofibrate in healthy subjects.~   "
75720|NCT02066194|"~     Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its~     interventional role is rapidly expanding. In order to improve patient's comfort and~     satisfaction during and after procedure, the use of sedation is usually recommended.~     However, sedation may be associated with serious adverse events of including hypotension,~     aspiration and respiratory depression. Moreover, the cost of performing the procedure would~     be increased due to the costs of the medications and the need of additional personnel in~     monitoring of the patient. As a result, the drive to seek alternative and safer approaches~     of pain-relief during EUS is ever present. Electroacupuncture (EA) has been used in~     Traditional Chinese Medicine (TCM) for more than 2000 years. The benefits and success of EA~     in treatment of acute and chronic pain of various origins have been well-recognised. Many~     researches have been performed to address the role of EA in treating pain and anxiety during~     OGD and colonoscopy. However, only limited data is availabe in the Chinese and the Western~     literature concerning the use of EA in EUS. Therefore it is worthwhile to conduct a~     well-designed study to evaluate the role of EA in treating pain during EUS.~   "
75721|NCT02066181|"~     This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate~     in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may~     stop the growth of tumor cells by blocking some of the proteins needed for cell growth.~   "
75722|NCT02066155|"~     African Americans are twice as likely to have diabetes compared to their White counterparts~     and experience higher rates of diabetes-related complications. Diabetes-related health~     disparities underscore the need for effective, culturally tailored approaches to promote and~     sustain diabetes self-management over time. Diabetes self-management education (DSME) is~     effective in improving diabetes outcomes in the short-term. However, many adults with~     diabetes cannot sustain achieved improvements without continued follow-up and support. The~     2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards~     for DSME and Support emphasize the importance of providing both initial DSME and on-going~     diabetes self-management support (DSMS) to assist people with diabetes in maintaining~     effective self-management throughout a lifetime. While a great deal is understood about how~     to provide effective, initial DSME, less is known about who, where, when, and how to provide~     effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in~     the healthcare system, while DSMS is not. This ultimately limits access and availability of~     DSMS programs, especially for low-income African Americans. Accordingly, there is critical~     need to develop, evaluate, and understand effective DSMS models that are ongoing,~     patient-driven, and embedded in the community.~   "
75723|NCT02066142|"~     Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference~     between TS and US in women with dense breast screened negative at 2D Mammography.~      If the equivalence between TS and US will be demonstrated, US may be substituted by TS with~     great benefits for the patients and for the healthcare resources.~      Aims~        1. Assess if TS may detect additional cancers in dense breast that approximate US~          detection capability but with less false positive findings than US.~        2. If TS detects new cancers in dense breast similarly to US (approximate rate or~          marginally lower rate), evaluate the the true positive/false positive ratio.~        3. Cost-analysis. In case of less false positives detected by TS, the true-positive /~          false positive trade-off might be strongly in favour of TS with a great potential of~          costs reduction.~   "
75724|NCT02066129|"~     The objective of this study is to determine whether, in children receiving low-dose inhaled~     corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of~     symptoms previously associated with upper respiratory illnesses and subsequent asthma~     exacerbations reduces the rate of severe asthma exacerbations treated with oral~     corticosteroids.~   "
75725|NCT02066116|"~     The investigators have developed the kinect-based upper extremity rehabilitation program and~     designed this protocol to prove the efficacy of this program.~      In brief, subacute stroke patients allocated to intervention group will receive the kinect~     based-rehabilitation program plus conventional occupational therapy and patients allocated~     to control group will receive the sham virtual rehabilitation plus conventional occupational~     therapy, for 10 days.~      20 patients with subacute stroke will be allocated into each group and after completing the~     10 days intervention, they will be assessed by using objective assessment tools for upper~     extremity function.~   "
75726|NCT02066103|"~     Assess the safety and feasibility of local oncological drug delivery into the bronchial wall~     after recanalization of subjects with malignant airway obstruction. Safety and feasibility~     (technical success) will be assessed.~      This localized delivery is intended as an adjunct therapy and all subjects will receive~     standard of care oncology therapy as determined by their treating physicians.~   "
75727|NCT02066090|"~     This research is planned to build a basis about the effect of acupuncture on serum metabolic~     parameters in pre-menopausal obese women with economic evaluation.~   "
75728|NCT02066077|"~     1. To determine the influencing factors of modified electroconvulsive therapy (MECT);~        2. To determine the influencing factors and reversibility of the cognitive impairment~          caused by MECT;~        3. To determine the duration of efficacy of MECT and its affecting factors.~   "
75729|NCT02066064|"~     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition~     colonoscopy with that of standard high definition colonoscopy.~   "
75730|NCT02066051|"~     The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and~     effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host~     disease (GVHD). Current treatment options for this disease are limited.~   "
75731|NCT02066038|"~     EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the~     first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'~     progression-free survival. The OPTIMAl trial indicated that those who received TKI and~     chemotherapy during the whole treatment window survived longest. Unfortunately, previous~     studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed~     to improve survival in unselected patients. To avoid the potential synergistic antagonism,~     the FAST-ACT II trial committed a sequential strategy and find a superiority in the~     combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the~     continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could~     obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.~      On the basis of these and other studies, the investigators hypothesized that a better~     sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out~     window before chemotherapy) would be more efficacious than chemotherapy alone. In this~     study, the investigators investigate the efficacy(PFS:progression free survival), safety,~     and adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib,~     when these drugs were used as first-line treatment in who had non-squamous lung carcinoma~     with EGFR gene mutation in China.~   "
75755|NCT02065726|"~     Nutritional derangements are very common in cancer patients and negatively affect survival,~     morbidity and quality of life. Intervention trials have demonstrated that nutritional~     counseling can improve energy balance, nutritional status and quality of life in patients~     undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect~     of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse~     events such as an impairment of nutritional status and quality of life. The nutritional~     properties of whey protein have recently raised attention. In view of the high content in~     cysteine these proteins can positively stimulate the synthesis of glutathione which, in~     turn, could contribute to the modulation of whole-body and cellular redox state. However,~     evidence on the role of this dietary intervention in cancer patients is limited.~   "
75732|NCT02066025|"~     Octava has two versions, each with a different intend of use.~      OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized~     clinical laboratories. The product is used for two following indications:~        -  Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed~          mammography and were determined negative for breast cancer. Being moderately sensitive~          (>55% sensitivity) the test is able to detect 55% of mammography false negatives. In~          addition, being highly specific (>95% specificity) it supplies additional evidence for~          true mammography negative result which will reduce examinees anxiety of being~          misdiagnosed as a result of high false negative mammography rate (10-30%)~        -  Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed~          biopsy after positive mammography and the biopsy result was negative. Being moderately~          sensitive (>55% sensitivity) the test is able to detect 55% of biopsy false negatives.~          In addition being highly specific (>95% specificity) it supplies an additional evidence~          for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.~      OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx~     authorized laboratories. Intend of use of OctavBlue is the following:~      • OctavBlue is indicated for women above 18 years old, who performed mammography and~     received doubtful results. Being highly sensitive (>95% sensitivity) the test can help to~     reveal 95% of positive cases; and being moderately specific (>55% specificity) - about half~     of negative cases. The test is not intended to be used as a standalone diagnostic technique~     but to supply additional information to a physician and help deciding about the further~     course of diagnosis.~   "
75733|NCT02066012|"~     Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated~     with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased~     macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular~     risk. Our main objective is to highlight the influence of iron overload on polarization~     capacity of monocytes into alternative macrophages (called M2). We therefore compare~     phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome~     without iron overload and lean subjects.~   "
75734|NCT02065999|"~     This is a multi-centre prospective longitudinal cohort study with the aim of collecting and~     storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug~     resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs~     for hepatitis C therapy.~   "
75735|NCT02065986|"~     This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.~      To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching~     HIV, we need to do a large trial in which half the men do not receive Truvada for one year.~     We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are,~     whether they would be willing to wait a year before they can take it. The reason it may not~     be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could~     mean there was more chance of catching HIV and other infections.~      As well as finding out if a large trial would be possible, this study will looks at other~     factors including:~        -  Whether people using PrEP change the number of partners they have sex with~        -  Whether people using PrEP change how often they use condoms~        -  Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).~      This information on changes in sexual activity over time is one of the most important~     aspects of the study, because we have never collected this before in the UK. This means we~     don't know what happens to people's sexual activity without PrEP! In October 2014 an interim~     analysis of the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly~     protective against HIV for gay men and other men who have sex with men (MSM) at high risk of~     infection. The PROUD Trial Steering Committee announced that participants on the deferred~     arm of the study, who had not yet started PrEP, should be offered the opportunity to begin~     PrEP ahead of schedule. As a result, we changed the study design and offered all enrolled~     participants the opportunity to access PrEP. All study participants will be followed up~     until study closure in October 2016~   "
75736|NCT02065973|"~     Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety~     and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV~     infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each~     based on a modified 3 + 3 dose-escalation study design. The study will be initiated with~     Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose~     of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides.~     All subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and~     dose escalation will be based on safety evaluation for determination of potential~     dose-limiting toxicity (DLT).~   "
75737|NCT02065960|"~     Most women with early breast cancer are treated with breast conserving therapy (BCT),~     consisting of breast conserving surgery (surgery to remove the cancer itself) followed by~     radiation to the breast. This treatment can take time and is associated with its own side~     effect profile. An innovative radiation technique called stereotactic body radiotherapy~     (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical~     organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been~     successfully used for a number of cancers and it is proposed that it could be used to~     eradicate breast cancer. This feasibility study will investigate the feasibility and safety~     of treatment using SBRT in women with early stage breast cancer.~      Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5~     treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast~     conserving surgery will be performed at 8-12 weeks after radiation to assess response to~     treatment. The primary outcome of the study will be feasibility, meaning the ability to~     deliver radiation treatment as planned. Secondary outcomes will include treatment related~     toxicity and pathological response.~      If this study shows that SBRT can be used to treat patients primarily, it will lead to~     further evaluation of SBRT for early breast cancer.~   "
75766|NCT02065583|"~     This study will measure the accuracy of a disposable, non-invasive device for the continuous~     monitoring of abdominal sounds, called the AGIS sensor (Acoustic Gastro-Intestinal~     Surveillance) in predicting patients' intolerance to feeding (defined as severe nausea,~     vomiting, or need to place a nasogastric tube within 4 hours of initiating a standard~     feeding protocol) following abdominal surgery. This will be a pragmatic, observational~     study.~   "
75738|NCT02065947|"~     The purpose of the study is to investigate if paravertebral block for breast surgery may~     improve postoperative analgesia and shorten length of hospital stay. Within a prospective~     clinical trial sixty women (ASA I - III) undergoing unilateral mastectomy surgery with~     axillary dissection are enrolled. Exclusion criteria are general infection and local~     infection at the site of planned puncture, anatomic deformities of the thoracic spine,~     coagulation disorders, allergy against local anesthetics or contrast agents, pregnancy or~     breast-feeding and BMI ≥ 30 kg/m2.~      Patients are randomly assigned to two groups, 30 patients each, by using block of four~     method. Group I patients receive paravertebral block at spine level Th 4 via catheter; Group~     II patients will have general anesthesia without nitrous oxide.~      Paravertebral block (PVB) will be entirely performed by one person (1st author) with the~     patient in prone position. In randomly selected patients the catheter localization will be~     detected by fluoroscopy after injection of 0.5 ml contrast agent. The catheter positioned at~     about 8 cm from skin level, a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with~     adrenaline 1:200,000 will be injected sequentially 10 ml each while withdrawing the catheter~     2 cm after the first and again 2 cm after the second injection. Then the catheter will be~     removed. Low dose intraoperative sedation is provided with IV midazolam 2-3 mg, ketamine 0.5~     mg/kg bolus and continuous propofol using target-controlled infusion (TCI) system aiming at~     effect site concentration (Ce) of 1 - 1.5 mcg/mL to allow spontaneous breathing. In case~     surgical approach is not tolerated, the regional block is graded insufficient, and it is~     switched to general anesthesia.~      At postoperative care unit (PACU) the pain score using visual rating scale (VRS) from 0 to~     10 (worst imaginable pain) is assessed at rest and on movement of the shoulder every 15~     minutes until 60 minutes. Analgesia is provided by IV morphine 0.04 mg/kg boluses with a~     15-min dosing interval to maintain VRS - score < 3. Time to first analgesic demand and 24-hr~     analgesics consumption is recorded as well as postoperative nausea and vomiting (PONV).~     Complications are recorded including those related to the paravertebral block, such as~     Horner's syndrome, epidural spreading, hypotension that is not related to another. Patients~     will be checked 6, 12, and 24hr postoperatively for adverse effects, pain scores, and~     satisfaction scores.~   "
75739|NCT02065934|"~     Clinical audit of in-hospital cardiac arrest management by in situ simulation~      Objectives: correct latent safety threats, knowledge gap, and crisis resource management~     (CRM)~      Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation~     scale. Exploratory outcomes: non technical skills, validated stress inventory, and~     questionnaire on perceptions of the simulation and organisational changes needed.~   "
75740|NCT02065921|"~     1. Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of~          the lungs, which is most commonly caused by smoking. It is characterized as not fully~          reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading~          cause of death worldwide, COPD is an important public health challenge and can be~          prevented and treated. It is estimated that at least 400,000 individuals in Switzerland~          are affected by COPD. This number may increase in the coming years due to increasing~          nicotine consumption.~           In response to the rising trend, the Global Initiative for Chronic Obstructive Lung~          Disease (GOLD) has established new guidelines on the global strategy for diagnosis,~          management and prevention of COPD. Systematic diagnosis and stratification are crucial~          for effective treatment measures.~           As COPD is an irreversible and progressive disease, its treatment aims an early~          detection and better management, which leads preventing progression. Disease management~          programs have shown that only patients who understand their exacerbation symptoms can~          benefit. Moreover, it is a major goal to improve health-related quality of life by~          reducing symptoms and decelerating disease progression.~           Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of~          the obstruction, and as a guide for optimal therapeutic measures.~        2. Aim of the study The objective of this project is to establish a COPD cohort database~          to allow high quality research on diagnosis, treatment, complication and progression of~          COPD on long-term course.~           Spirometry should be used consistently for the diagnosis and the monitoring of the~          development of the disease. Using collected information such as spirometric data,~          disease progression's data and therapeutic measures should help improve the management~          and self-management of the patients.~        3. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD~          patients from northern and western Switzerland, who are managed under primary care~          setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the~          study.~           Currently, 67 General practitioners (GPs) are participating in our Study. Each GP~          recruits 1-20 patients with presumed mild to very severe COPD according to criteria of~          the Global Initiative for Chronic Obstructive Lung disease [GOLD].~           Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and~          examination status is recorded. Data is entered into an online database either by the~          physicians or by study team after receiving the collected data questionnaires by~          facsimile.~           Data collection includes demographic data, physical examination, spirometric~          parameters, medical treatment and exacerbation history besides death.~           A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess~          lung function. All participating physicians were instructed on the usage of the~          spirometer and on how to complete spirometry according to the guidelines. For the~          assessment of the severity of COPD, we use the spirometric data provided by the GPs.~          The COPD severity is interpreted according to criteria of the GOLD committee.~           3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed~          in primary-care practices.~           3.3 Inclusion criteria~             -  Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation~               of a bronchodilator <200 ml and <12%).~             -  Age: > 40 years~             -  Both genders~             -  Smokers or ex-smokers of at least 20 pack years.~             -  Informed consent.~           3.4 Archiving and Data Retention All study-related records such as medical records,~          informed consent documents, information regarding participants who discontinued, and~          other pertinent data will be maintained and therefore retained as long as required by~          the applicable Swiss regulatory requirements (10 Years).~           3.5 Data security The complete data of the study will be entered anonymously into a~          database. The data is password-protected and can only be accessed by investigators and~          study members.~        4. Publication and authorship 4.1 Publication policy~      Authorship credit is based on:~        1. Substantial contribution to conception and design, acquisition of data, or analysis and~          interpretation of data.~        2. Drafting the article or revising it critically for important intellectual content.~        3. Final approval of the version to be published. Each author should have participated~          sufficiently in the work to take public responsibility for appropriate portions of the~          content.~   "
75741|NCT02065908|"~     In the proposed project the investigators will asses whether changes in expression of~     selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of~     cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.~   "
75742|NCT02065895|"~     The purpose of this study is to test the ability of an advanced external Physiologic Insulin~     Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem)~     to get acceptable meal responses over a range of gain. Gain is defined as how much insulin~     is given in response to a change in a patient's glucose level.~      This study also examines the effectiveness of the external Physiologic Insulin Delivery~     (ePID) closed-loop insulin delivery computer software. The investigators would like to~     assess whether fasting target levels can be achieved as the closed-loop gain increases or~     decreases, and to evaluate the system's ability to produce an acceptable breakfast meal~     response.~   "
75743|NCT02065882|"~     The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in~     patients with congenital fibrinogen deficiency.~   "
75744|NCT02065869|"~     This study will evaluate pediatric patients with malignant or non-malignant blood cell~     disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa~     and beta cells that comes from a partially matched family donor. The study will assess~     whether immune cells, called T cells, from the family donor, that are specially grown in the~     laboratory and given back to the patient along with the stem cell transplant can help the~     immune system recover faster after transplant. As a safety measure these T cells have been~     programmed with a self-destruct switch so that they can be destroyed if they start to react~     against tissues (Graft versus host disease).~   "
75745|NCT02065856|"~     This trial is an open, national, multi-centre trial. The trial will be initiated in December~     2013 and subjects will receive treatment for 6 weeks.~      Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with~     immediate access to Adverse Events registered in the clinical database. The composition,~     procedures and deliverables of the Clinical Safety Group will be detailed in a Safety~     Agreement prior to trial start.~   "
75746|NCT02065843|"~     This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina~     mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of~     asymptomatic, impacted mandibular third molars.~   "
75747|NCT02065830|"~     The aim of this study will be to evaluate the safety and the efficacy of a new robotic~     exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other~     neurological disease with an impairment of lower limbs.~   "
75748|NCT02065817|"~     This is a pilot study to determine the optimum time and dose to draw blood samples using a~     tracer for HDL kinetics.~   "
75749|NCT02065804|"~     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one~     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of~     the patients indicating that a large number of patients each year suffer from debilitating~     reduction in health-related quality of life.~      This study examines the effect of ultra-sound guided blocks with local anesthesia in the~     groin in regard to pain relief and sleep quality.~      The hypothesis of the study is that a block will confer significant pain relief to patients~     with severe chronic pain following laparoscopical groin hernia repair.~   "
75750|NCT02065791|"~     The goal of this study is to assess whether canagliflozin has a renal and vascular~     protective effect in reducing the progression of renal impairment relative to placebo in~     participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD)~     and macroalbuminuria, who are receiving standard of care including a maximum tolerated~     labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin~     receptor blocker (ARB).~   "
75751|NCT02065778|"~     The purpose of this study was to study the safety and effect of stem cell therapy on the~     functional recovery in patients with chronic stroke.~   "
75752|NCT02065765|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the compassionate use program.~   "
75753|NCT02065752|"~     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two~     components combined in one tablet) of canagliflozin and metformin extended release (XR)~     tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin~     (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.~   "
75756|NCT02065713|"~     Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy~     of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has~     not been previously studied in randomized controlled trials as a primary endpoint.~      In this investigator initiated clinical trial the investigators aim to test the hypothesis~     that the combination therapy of golimumab and methotrexate (MTX) will result in a~     significant improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve~     psoriatic arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral~     and axial involvement, skin and nail psoriasis, inflammation and damage of the feet and~     hands assessed by magnetic resonance imaging (MRI), composite indexes of disease activity,~     remission, function and quality of life will be determined.~      This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel~     design trial. 136 patients with active dactylitis, refractory to at least two systemic~     non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be~     included and centrally randomized to golimumab in combination with MTX versus MTX~     monotherapy, in a 1:1 ratio. The study duration will be 24 weeks.~      The investigators expect the results from this trial will contribute to a better definition~     of the treatment algorithm of PsA patients with dactylitis.~   "
75757|NCT02065700|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.~      Participants will be enrolled in this open-label long-term follow-up study after they have~     completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204~     (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and~     tolerability) when taking filgotinib. During the course of the study, participants will also~     be examined for long-term effects of filgotinib administration on disease activity~     (efficacy), subjects' disability, fatigue, and quality of life.~   "
75758|NCT02065687|"~     This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin~     hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating~     patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better~     by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel~     and carboplatin is more effective with or without metformin hydrochloride in treating~     endometrial cancer.~   "
75759|NCT02065674|"~     Objective: To ascertain whether homoeopathic medicine ABROMA AUGUSTA has a clinical role in~     changing the Glycated Hb Level in Diabetes mellitus Type II.~      Abstract:~      Background: Type 2 diabetes mellitus (T2DM) is one of the most important epidemic diseases~     in the world in this century, and accounts for 90% of cases of diabetes globally. Studies~     have suggested that Abroma Augusta plays a role in acute controlling blood glucose level.~     The aim of this study was to evaluate the efficacy of Abroma Augusta Ѳ in chronic control~     through GlycatedHb (HbA1c %) in Diabetes Mellitus Type 2 (NIDDM) as a pretest post-test~     study.~   "
75760|NCT02065661|"~     EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The~     devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the~     device through a nasogastric (NG) tube and causing a color change in the device. The color~     change is then compared to the reference indicator on the device to determine a pH value of~     the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the~     clinician from being exposed to the aspirate.~        1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the~          devices by comparing the reading on the 2 devices to a standard clinically approved pH~          probe.~        2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH~          indicator could have been used to determine proper placement of the NG tube when~          initially placed.~   "
75761|NCT02065648|"~     The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo~     NATIVE sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA~     performed as part of routine clinical care in patients with normal renal function to~     determine if the non-contrast NATIVE sequence is a viable alternative to contrast enhanced~     MRA in patients with renal insufficiency. There are no interventions--this is an~     observational study.~   "
75762|NCT02065635|"~     -  Nitric oxide (NO) is a free radical in gas state which plays an important role in a~          variety of processes relevant to respiratory physiology. It represents a means of~          detecting airway hyperresponsiveness and appears to have a strong correlation with the~          eosinophilic infiltration of the airway. Patients who suffered bronchospasm or~          laryngospasm intraoperatively or postoperatively showed higher levels of exhaled NO.~        -  Propofol modifies NO production by stimulating the constitutive synthesis of NO and by~          inhibiting the inducible production of NO. It seems to exert protective effects on~          acute lung injury (ALI) in experimental models and it can possibly reduce exhaled NO.~          There is also evidence that some intravenous anesthetic agents can influence chemotaxis~          of eosinophils in vitro.~        -  Variation of exhaled NO and eosinophils in surgical patients undergoing anesthesia has~          not been studied before. Therefore, the aim of this study will be to investigate the~          differential impact of maintenance of general anesthesia with propofol versus~          maintenance with sevoflurane on exhaled NO and eosinophil blood count.~   "
75763|NCT02065622|"~     To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in~     subjects with moderately to severely active Ulcerative Colitis.~   "
75764|NCT02065609|"~     The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with~     89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.~   "
75765|NCT02065596|"~     This is a phase I/II study of patients with sickle cell disease. It aims to find out if~     people with sickle cell disease can be cured by changing their immune system before they~     have blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see~     if this drug changes patients immune system and reduces the patient's cells (host) from~     rejecting donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell~     transplant.~   "
75767|NCT02065570|"~     This study will evaluate higher versus standard adalimumab dosing regimens for induction and~     maintenance therapy in subjects with moderately to severely active Crohn's Disease and~     evidence of mucosal ulceration.~   "
75771|NCT02065518|"~     The purpose of this project is to compare three treatment regimens for knee injury to the~     standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted~     vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be~     supplemented by the standard of care and compared to a group who receive the standard~     rehabilitation only.~      The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength~     Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members~     with knee injury to a standard rehabilitation protocol program only. All groups will~     participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks~     to compare main and interactive effects over time.~   "
75772|NCT02065505|"~     To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its~     correlation with the respiratory capacity of individuals with hemiparesis, with the aid of~     biomedical instrumentation, comparing the method performed in soil and therapy pool.~   "
75773|NCT02065492|"~     Children with thalassemia may have high iron levels after receiving blood transfusions.~     These high iron levels can have damaging effects on the body, especially the heart.~     Conventionally only chelation therapy was given for prevention of iron buildup in the heart.~     However, current research has shown that another drug, amlodipine, also helps to slow down~     the deposition of iron in the heart. This study is designed to see if patients receiving~     amlodipine along with their regular chelation therapy have a slower rate of iron buildup in~     the heart when compared with patients who are receiving chelation only.~   "
75774|NCT02065479|"~     Numerous studies have shown that pharmacodynamics (PD) response profiles vary among~     clopidogrel treated patients and that individuals with reduced response have an increased~     risk of recurrent ischemic events. There are multiple factors contributing to clopidogrel~     response variability, including genetic variations of the cytochrome P450 (CYP) 2C19 enzyme.~     In particular, loss-of-function (LOF) alleles of the CYP2C19 enzyme reduce transformation of~     clopidogrel pro-drug into its active metabolite. Thus, patients carrying LOF alleles have~     lower levels of clopidogrel's active metabolite as well as diminished platelet inhibition,~     which translates into an increased rate of adverse cardiovascular events, particularly in~     the setting of percutaneous coronary intervention (PCI). Prasugrel and ticagrelor are novel~     generation P2Y12 receptor inhibitors characterized by greater PD potency and reduced~     ischemic event rates compared with clopidogrel, and are not affected by CYP2C19 LOF~     polymorphisms. However, to date there are limited head-to-head PD comparisons between these~     two new P2Y12 receptors blockers, and there are no studies assessing on how these agents~     behave among CYP2C19 LOF carriers. The aim of the present study is to compare the PD effects~     of prasugrel versus ticagrelor in patients undergoing PCI with CYP2C19 LOF alleles using the~     novel point-of-care genetic testing Spartan RX-CYP2C19 which permits accurate and rapid~     identification of CYP2C19 genetic status.~   "
75775|NCT02065466|"~     1.1. Primary Objectives~      1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of~     bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic~     malignant melanoma.~        -  To define the MTD of the combination (Phase I component).~        -  To determine progression free survival (Phase II component). 1.2. Secondary Objectives~             1. To separately evaluate the response rate and duration of both the brain and~               extra-cranial systemic metastases.~             2. To define the toxicity of the regimen.~             3. To tabulate the toxicity of the radiotherapy to the brain and compare with known~               toxicities of radiotherapy to the brain in melanoma and brain metastases.~             4. To use the data generated to plan definitive controlled clinical trials of the~               combination.~             5. To determine the overall response rate (Phase II component).~   "
75776|NCT02065453|"~     Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are~     accomplished laparoscopically in the investigators current surgical practice to allow women~     a quicker recovery than a traditional large incision. Disposable laparoscopic devices have~     been developed to assist in the completion of hysterectomies. These disposable energy~     sources are only used once, but offer an improved safety and energy profile in that they~     reliably control bleeding with little damage to surrounding tissue and potentially save~     time. Reusable energy instruments can be sterilized and reused for multiple cases. Operating~     room time is expensive. The investigators calculate that if 6.7 minutes of time can be saved~     using the disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz~     Laparoscopic Shears, the time savings could justify the cost of the device.~   "
75777|NCT02065440|"~     To determine whether ebastine/pseudoephedrine is effective on subacute cough.~   "
75778|NCT02065427|"~     The purpose of this study is to determine wether a multi-factor intervention involving the~     primary caregiver of a dependent patient, with the goal of improving his or her social and~     family support and carried out by the professionals of the patient's regular PHCT, will~     decrease the burden and increase quality of life for the primary caregiver.~   "
75779|NCT02065414|"~     Participants will be given special instructions about taking care of their teeth during the~     18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks~     and 4 weeks. At that first visit, they will be examined by a dentist, who will examine their~     mouths with a dental instrument to determine whether they qualify to participate in the~     trial. Someone who works for the dentist will also take some oral measurements.~      Participants who qualify to be in the study will receive a treatment for their gingivitis~     and have an equal chance of being assigned to one of three treatment groups. Participants in~     all three groups will be given toothpaste that is already available in stores. They will~     brush their teeth twice daily in their regular manner. After brushing, participants in one~     group will use an experimental mouth rinse that is not available in stores. Another group~     will be given a mouth rinse to use that is already available in stores, and the third group~     will use a placebo mouth rinse. After they receive their assigned products participants will~     be supervised while they brush their teeth and rinse to ensure they understand exactly how~     to use the products. Participants will be required to stay at the site 20 minutes after the~     first use of product during visit 1 to monitor any potential allergic reaction. All other~     brushing and rinsing over the next four weeks will be at home, but participants will be~     required to keep a diary to record their brushing and rinsing times twice each day.~      Participants will be required to bring their diaries and any left-over toothpaste and mouth~     rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4~     weeks. At those appointments, the dentist will examine their mouths, make sure there are no~     safety concerns, and examine again to get the measurements needed. One of the dentist's~     staff members will take other measurements as well.~      The study will determine the measured effects of the experimental mouth rinse on bleeding as~     a result of gingivitis, and compare these results to the mouth rinse that is already~     available.~   "
75780|NCT02065401|"~     The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after~     administration of granule and tablet formulations of a deferitazole disodium salt to a~     capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in~     healthy adult subjects.~   "
77368|NCT02044679|"~     Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide~     range of fluid intake behaviors~   "
75781|NCT02065388|"~     Purpose:~      Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual~     variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and~     warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing~     algorithm which can predict patients required warfarin dose, thus could prevent warfarin~     induced warfarin adverse events.~      Methods:~      The investigators recruited patients with indications for warfarin, the genotypes of VKORC1~     and CYP2C9 were determined by the hospitals and verified by National Center for Genome~     Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin~     dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic~     Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard~     of care. The investigators aimed to determine whether using genetic dosing algorithm can~     lead to more stable dose and safer use of the drug.~   "
75782|NCT02065375|"~     This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic~     Suspension in the treatment of patients who have inflammation and pain following ocular~     surgery.~   "
75783|NCT02065362|"~     Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study~     using special immune cells.~      Most patients with NPC show evidence of infection with the virus that causes infectious~     mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is~     found in the cancer cells of almost all patients with advanced stage NPC, suggesting that it~     may play a role in causing the disease. The cancer cells infected by EBV are able to hide~     from the body's immune system and escape destruction. We want to see if special white blood~     cells, called T cells, that have been trained to recognize and kill special parts of EBV~     infected cells can survive in patient's blood and affect the tumor.~      We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have~     seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can~     improve this treatment.~      First, we want to give T cells where more of the cells recognize at least two of the four~     EBV proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells.~      Second, we found that T cells work better if we add a receptor to the T cells called DNR~     (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by~     cancer cells that helps them escape being killed by the immune system. In this study we will~     therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells).~      In other clinical studies using T cells, some investigators found that giving chemotherapy~     before the T cell infusion can improve the amount of time the T cells stay in the body and~     therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is~     called lymphodepletion since the chemotherapy is specifically chosen to decrease the number~     of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should~     allow the T cells we infuse to expand and stay longer in their body, and potentially kill~     cancer cells more effectively.~      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and~     fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used~     for lymphodepletion in immunotherapy clinical trials.~   "
75784|NCT02065349|"~     The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock~     (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy~     or postherpetic neuralgia determined by the change in the average daily pain intensity in~     patients that initially respond favorably to treatment with ASP8477.~   "
75785|NCT02065336|"~     The purpose of this study is to determine whether ARC-520 in combination with entecavir is~     effective in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection.~   "
75786|NCT02065323|"~     This study will evaluate if adding the investigational drug Dovitinib to standard androgen~     ablation therapy (ADT) is beneficial in prolonging the time to disease progression in~     patients with metastatic prostate cancer who are receiving ADT for the first time.~      Dovitinib belongs to the class of drugs known as tyrosine kinase receptor inhibitors.~     Tyrosine kinase receptor inhibitors have been shown to have anti-tumor effects and inhibit~     new blood vessel formation. New blood vessel development is necessary for the growth and~     spread of certain tumors, such as prostate cancer. It is thought that by inhibiting new~     blood vessel formation, any existing or new tumors may be unable to grow. Dovitinib targets~     existing cancer cells and also works to stop the formation of new blood vessels.~      Patients will be randomly assigned to received ADT alone or ADT plus Dovitinib. ADT will be~     administered per standard of care. Dovitinib will be taken by mouth once daily for 5~     continuous days, followed by 2 days with no Dovitinib. This schedule will repeat and~     continue until disease progression or removal from treatment for other reasons. Participants~     may start ADT prior to entering the study; however, treatment with Dovitinib must begin no~     later than 120 days from the start of ADT.~      Participants will be asked to donate blood samples for research purposes; this is an~     optional part of the study. Research on blood samples will study circulating tumor cells and~     certain biomarkers (proteins on cells) to increase the understanding of prostate cancer and~     explore if certain biomarkers can help predict how tumors will react to treatment. Samples~     of existing tumor tissue will also be examined for research purposes.~   "
75787|NCT02065310|"~     The purpose of this study is to see if the CEdG assay can produce internally consistent~     results and initiate its validation as a biomarker for diabetes in humans.~   "
75788|NCT02065297|"~     The aim of this open, controlled, multicentre biomedical research study is to identify new~     markers specifically associated with Horton's disease. This would make it possible to~     improve the diagnosis and management of this disease.~      Participation consists in taking one or several blood samples depending on the group~     patients/controls.~   "
75789|NCT02065284|"~     Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic~     auditory cues (like a beat) to help improve patients' movements, especially when walking.~      The purpose of this study is to compare the effect on walking performance of a home based~     walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without~     RAS, or to RAS without walking exercise.~      A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS)~     on brain activity in patients with Multiple Sclerosis while performing mental imagery of~     walking.~   "
75805|NCT02065076|"~     The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an~     effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a~     pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two~     treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The~     change in serum potassium levels will be compared in both treatment groups. The proportion~     of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will~     also be compared. Finally, side effects will be reported for each treatment arm.~   "
75864|NCT02064309|"~     The primary objective of this clinical investigation is to investigate the safety of~     implantation of the human islet containing device Beta-Air in type 1 diabetic subjects.~      The secondary objective of this clinical investigation is to investigate if the~     transplantation of macro-encapsulated human islets within the Beta-Air device can provide~     improved glycaemic control in type 1 diabetes patients with reduced incidences of~     hypoglycaemic episodes.~   "
75790|NCT02065271|"~     Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and~     accounts for a considerable part of health care costs. Herbal supplements are used in many~     cultures for the prevention and treatment of many different conditions. Due to lack of~     scientific proof, the application in western cultures are minimal. Animal studies have shown~     that many constituents of such herbal supplements may have beneficial effects on several~     important parameters known to be affected in T2D. Still, no scientific proof in humans is~     available. We therefore aim to investigate the effect of 4-week herbal supplementation on~     glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with~     increased fasting glucose levels or a decreased glucose tolerance.~      Objective: The primary objectives are to investigate if 4-week herbal supplementation in~     subjects with increased fasting glucose levels or a decreased glucose tolerance has a~     positive effect on blood glucose levels and glucose tolerance. The secondary objectives are~     to investigate if 4-week herbal supplementation in subjects with increased fasting glucose~     levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels,~     inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and~     during an OGTT test.~      Study design: This study is a randomized, double-blind, placebo controlled cross-over trial~     in which two different treatments will be evaluated e.g. an intervention with the herbal~     mixture and a placebo. Each person will obtain both treatments in random order for four~     weeks with a wash out period of four weeks in-between. Fasting blood samples will be~     collected and subjects will receive a OGTT, paralleled by a PWA before and after 4-week~     supplementation.~      Furthermore, after 4-week supplement intake we will collect a urine sample and collect an~     adipose tissue biopsy. The whole trial will last three months.~      Study population: 26 overweight males and females 50-75yrs old with an increased fasting~     glucose or with an impaired glucose tolerance.~      Intervention: Two intervention periods of 4-weeks in which participants will take three~     times a day a supplement of 500mg herbal or placebo.~      Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as~     determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA,~     adipose tissue an white blood cell gene expression and markers of inflammation .~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects that will participate in the study will invest a total of 16.5 hours.~     Blood collection by vena punctures/insertion of the venflon and the collection of an adipose~     tissue biopsy can occasionally cause a local hematoma or bruise and some participants may~     report pain or discomfort. The herbal supplements contain small amounts St. John's wort,~     which may affect the function of liver enzymes. We will therefore monitor liver function~     parameters during the supplementation period. Furthermore, subjects are excluded if they use~     medication known to be affected by St. John's wort. Participant will donate 284ml of blood,~     dispersed over 12 weeks.~   "
75791|NCT02065258|"~     Background: Asthma is a chronic inflammatory airway disease characterized by reversible~     obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and~     breathing exercises have been demonstrated to benefit asthmatic patients; however, there is~     no evidence comparing the effectiveness of the treatments. Objective: To compare the effects~     of aerobic and breathing exercises on clinical control (primary outcome), psychosocial~     morbidity and daily life physical activity (secondary outcome) in patients with~     moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate~     variability and airway and systemic inflammation will be evaluated. The initial hypothesis~     will be that both exercises present improved clinical control of asthma. Methods:~     Forty-eight asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and~     breathing exercises (BG). All treatments will be performed twice a week for 3 months,~     totalizing 24 sessions of 40 minutes each. Both groups will complete an educational program~     consisting of 2 classes at the beginning of the interventions. Before and after~     interventions, the following parameters will be quantified: clinical control, health related~     quality of life, levels of anxiety and depression, maximal exercise capacity, autonomic~     nervous imbalance, daily living physical activity, thoracoabdominal kinematics, inflammatory~     cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory~     cytokines. Asthma symptoms will be quantified monthly using diaries. Kolmogorov-Smirnov test~     will be used to analyze the data normality, and a two-way ANOVA with repeated measures with~     appropriate post hoc test (Student Newman Keuls) will be used to compare the inter and~     intra-groups differences~   "
75792|NCT02065245|"~     Before initiating the full randomized study, a Pilot Safety Phase will be performed. The~     randomized portion of this trial will be conducted after a full review of the safety data~     from the Pilot Phase by the Data safety monitoring board.~      Following the Pilot Phase of fifteen (15) subjects, up to thirty (30) subjects are scheduled~     to undergo infusion and meeting all inclusion/exclusion criteria will be evaluate at~     baseline.~      An additional twenty (20) subjects will be enrolled in a safety trial for antibiotic free~     cells.~   "
75793|NCT02065232|"~     This is a pain survey study that will compare the level of discomfort experienced by breast~     cancer patients after injection of either technetium-labeled sulfur colloid or~     technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy~     (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original~     surgical plan will be asked to participate in this study and be randomized to receive either~     technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection,~     patients will complete pain questionnaires to measure the amount of discomfort they are~     feeling during and after they receive the injection. There will be no change to the~     patient's treatment plan other than the addition of pain questionnaires. The investigators'~     hypothesis is that patients will feel less discomfort after injection of tilmanocept versus~     sulfur colloid.~   "
75794|NCT02065219|"~     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one~     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of~     the patients indicating that a large number of patients each year suffer from debilitating~     reduction in health-related quality of life.~      This study examines the effect of ultra-sound guided blocks with local anesthesia in the~     groin in regard to pain relief and sleep quality.~      The hypothesis of the study is that a block will confer significant pain relief to patients~     with severe chronic pain following open groin hernia repair.~   "
75795|NCT02065206|"~     While few students may consider a career in research at baseline, receiving information from~     peers via online social networks represents a potential way of reaching underserved minority~     students.~      This study addresses a critical problem in the process to diversify the pipeline of clinical~     researchers - how to cultivate baseline interest in research among high achieving youth~     before they participate in pipeline programs. We will seek to challenge existing paradigms~     of studying effectiveness of interventions to promote entry of minority youth into clinical~     research careers through testing a novel social media campaign that aims to increase~     interest in research careers among schoolmates of students in a pipeline program. We are~     testing the use of of peer-created and inspired videos about career choice as a novel way to~     develop messages that have potential to influence teens.~      Should this research program be successful, it will yield valuable insights for researchers~     and educators who are attempting to train minority students about the importance of~     involving youth in creating materials to recruit and retain minorities into pipeline~     programs and educational programs targeted towards clinical research.~   "
75886|NCT02064023|"~     This study is investigating whether insulin treatment with the insulin pump or with multiple~     daily injections (MDI) gives better outcomes for mother and baby in pregnant women with~     pregestational diabetes. Participants will be randomized to use either the insulin pump or~     MDI.~   "
75796|NCT02065193|"~     The China SCORE study is a prevalence study of Autism Spectrum Conditions (ASC) in 14~     regions in mainland China. It will include the following steps:~        1. Large population-based screening This study will be conducted in urban areas but not~          rural areas across mainland China. One city of each region will participate, and in~          total there will be 14 cities for screening. Within each city, a number of 40 to 60~          ordinary primary schools will be randomly selected from the defined region. All the~          students who are in 1st to 4th grade will asked to participate in order to form a~          sample of approximately 20,000 students.~           Screening questionnaires The screening pack includes the Chinese CAST, the AQ-Child,~          the AQ-Adult short version (10 items), and risk factors questionnaire. An information~          sheet and consent form will be included in the pack as well.~        2. Further assessments We expect approximately 5% on the CAST will score positive in~          ordinary school population. Thus, for a 20,000 sample, we would expect 900 positives~          (90% response rate). All the screen-positives and a random selected 5% from borderline~          group will be invited for clinical assessment. The diagnosis of clinical assessment~          will be divided into three categories: definite ASC, suspected ASC, and non-ASC. Then~          all the children with clinical assessment results as definite ASC and suspected ASC and~          a randomly selected 10-20 non-ASC will be invited for research diagnostic assessment~          using the ADOS and ADI-R, as well as RPM as IQ test. After that, the consensus~          diagnosis between ADOS/ADI-R assessment and the clinical diagnosis will be the final~          diagnosis.~        3. Case identification in special schools All the children in special schools or training~          institutes in study region will be asked to fill in the screening pack. The children~          who do not attend any ordinary or special schools will be identified according to their~          residential ID in the studied regions. All screen-positives in special education will~          be assessed using the ADOS and ADI-R. Then those who met the criteria of ASC on ADOS~          or/and ADI-R will be assessed by psychiatrists and the clinical diagnosis will be the~          final diagnosis.~      If we combine the prevalence of ordinary schools and special schools together, we will get~     an estimate of the prevalence of ASC in school-population in China. If we combine all the~     cases identified from schools and from residential records, we will generate an estimate of~     the prevalence of ASC in the general population in mainland China.~   "
75797|NCT02065180|"~     This randomised controlled trial studies the effect of a commercially available nutritional~     supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol~     levels.~   "
75798|NCT02065167|"~     The purpose is to assess the safety and feasibility of cellular therapy derived from bone~     marrow, to help bone healing in patients with avascular necrosis of the hip.~   "
75799|NCT02065154|"~     The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the~     post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The~     primary objective is to determine the incidence of grade II-IV acute GVHD following~     Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide~     (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and~     mismatched unrelated (MMUD) donors. Other objectives for this study will be the~     determination of disease-free survival (DFS) and overall survival (OS) following allo HCT~     and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD~     transplantation. Disease recurrence and time to recurrence in patients receiving~     post-transplant cyclophosphamide compared to historical control without post-transplant~     cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the~     time of onset, severity, responsiveness to treatment, organs involved of acute and chronic~     GVHD as well as observation of Immune Reconstitution over time.~   "
75800|NCT02065141|"~     The aim of the present study is to validate a new method in healthy volunteers and those~     diagnosed with COPD and CHF that is able to measure protein digestion and absorption~     simultaneously. This method is used to quantify digestion and absorption in patients who are~     suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be~     used to develop treatment strategies to improve protein digestion and absorption in these~     patient groups.~   "
75801|NCT02065128|"~     Irritable larynx syndrome (ILS) is a hyperkinetic laryngeal dysfunction that is~     characterized by a persistent cough, voice changes, or breathing difficulties, which are~     often triggered by an irritant. Diagnosis of ILS is difficult and typically made via a~     thorough review of the clinical history and, occasionally, the patient's reaction to an~     odor-provocation test. Standard treatment for ILS is behavioural therapy with a speech~     language pathologist (SLP), which provides symptom improvement for most patients. However,~     currently, there are no objective measures of the upper airway hyper-responsiveness in this~     condition to assist in diagnosing and monitoring disease severity.~      Since the cough is irritant-based, it is anticipated that patients with ILS will have a~     hypersensitivity to the irritant capsaicin. Capsaicin is the active component of chili~     peppers and is what makes them hot. The capsaicin cough challenge is a well recognized test~     that involves inhaling different concentrations of capsaicin solutions to determine a cough~     reflex sensitivity.~      The purpose of this research study is to confirm that ILS patients have a hypersensitivity~     to capsaicin compared to healthy volunteers. If a hypersensitivity is observed in ILS~     patients, the second objective of this study will be to see if behavioural therapy improves~     the cough reflex sensitivity in this patient population.~   "
75802|NCT02065115|"~     This study seeks to determine if cryoanalgesia in the form of ice application could be an~     effective analgesic when applied before arterial puncture.~   "
75803|NCT02065102|"~     Coronary artery stenting has evolved as an effective treatment for angina and involves~     stretching up narrowings within the heart arteries using a balloon (coronary angioplasty)~     before implanting a small metal scaffold (stent) to splint the artery open. It is imperative~     that stents are fully expanded when they are deployed. If not, then patients are exposed to~     the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent~     renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and~     70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart~     attacks.~      Arguably, visualising stents and ensuring adequate stent expansion is most challenging in~     patients with extensive hardening, or calcification, of the heart arteries. Optical~     coherence tomography is a novel technique that utilises near-infrared light to look inside~     small blood vessels in fine detail. It is 10 times more powerful than the best existing~     technique, intravascular ultrasound.~      The purpose of this study is to compare the utility of optical coherence tomography with~     intravascular ultrasound in patients with heavily calcified heart arteries undergoing~     rotational atherectomy and coronary stent insertion. It is hoped that the results of this~     pilot study will provide proof-of-principle and justification for a larger clinical trial to~     formally assess the role of optical coherence tomography to guide coronary angioplasty and~     stenting in patients with heavily calcified coronary arteries.~   "
75804|NCT02065089|"~     We would like to collaborate and further develop an ipad-based, interactive quiz game~     'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients.~     These gaps can be used to improve patient education.~   "
75823|NCT02064842|"~     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of~     TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug~     interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate~     the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are~     co-administered (Part 2) in healthy Japanese participants.~   "
75806|NCT02065063|"~     This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to~     determine the recommended dose and schedule for the orally administered MEK inhibitor~     trametinib, given together with the CDK4/6 inhibitorpalbociclib in subjects with solid~     tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended~     dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers~     safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a~     change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will~     receive trametinib and/or palbociclib until disease progression, death, consent withdrawal~     or unacceptable adverse event (AE).~   "
75807|NCT02065050|"~     This study is being performed to evaluate whether a comprehensive discharge planning and~     close follow up for one year can improve clinical outcomes and cut costs of care for~     patients with poorly controlled diabetes. The study takes a high risk approach and is~     focused on patients admitted to hospital for elective surgery with HbA1c >8%. Secondary~     goals include improving teamwork and communication for clinicians within the team and~     teaching nurse practitioners and physicians-in-training how to work effectively within~     interdisciplinary teams. Investigators anticipate that the results of this project may lead~     to the following benefits: 1) improved health outcomes for surgical patients with diabetes,~     2) improved strategies for better communication within interdisciplinary health care teams,~     and 3) decreased health care costs.~   "
75808|NCT02065037|"~     Colorectal cancer is the second most common cancer in the world and the second leading cause~     of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a~     well characterized adenoma to carcinoma progression. The removal of such precursor lesions~     reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of~     neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce~     spasm of the colon have been investigated to increase adenoma detection rates including the~     use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body~     temperature is postulated to have spasmolytic effects. Administration of warmed carbon~     dioxide during colonoscopy may improve polyp detection.~      Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be~     compared to standard room temperature air insufflation to see if there is a greater~     detection of polyps per patient.~      Methods: Patients undergoing colonoscopy for screening and surveillance indications will be~     included and randomized to receive either room temperature room air or warmed carbon dioxide~     (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on~     indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate~     will be the primary outcome. Secondary outcomes will include adenoma detection rate and~     advanced lesion detection rates.~   "
75809|NCT02065024|"~     Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps)~     has been shown to exert a synergic effect in reducing cardiovascular risk and bone~     remodeling markers (formation and resorption). The present project aims to assess the~     influence of technological treatment and genetic variability on the bioavailability and the~     health effects of the added components (Ps, b-Cx), in particular to their potential role in~     prevalent disorders.In vitro and in vivo studies will be carried out to this effect. In~     vitro and in vivo studies (human intervention study) will be performed and cardiovascular,~     bone turnover and inflammation markers will be evaluated. Additionally, an in vitro colonic~     fermentation model and cell cultures will be used to explore anticarcinogenic effects and~     potential cytotoxicity.~   "
75810|NCT02065011|"~     Primary Objective:~      To evaluate the long-term safety and tolerability of UshStat® in patients with Usher~     syndrome type 1B~      Secondary Objective:~      To assess long-term safety and biological activity of UshStat®~   "
75811|NCT02064998|"~     The purpose of this study is to evaluate the efficacy of three mobile phone applications,~     Promillekoll, PartyPlanner and TeleCoach among university student union members with~     problematic drinking. Two trials are conducted, one a three-armed randomized controlled~     study, and the second a two-armed randomized control study. Outcomes are measured in terms~     of changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data~     gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of~     alcohol consumption and give feedback of estimated blood alcohol concentration levels.~     PartyPlanner also allows for planning an alcohol consumption event in advance and for later~     comparison of the plan with actual consumption. Study 1 compares these two apps with a~     control group. In Study 2, participants reporting alcohol consumption above the weekly~     recommended level are redirected to randomized assignment to an in-depth app, TeleCoach,~     which offers different exercises for reducing alcohol use. After 6 weeks the controls are~     offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app~     access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration.~      Hypotheses:~      Study 1: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce~     their alcohol use to a larger extent than the control group at follow-up compared to the~     baseline level. 2. The planning function in PartyPlanner will be associated with an~     increased decrease in alcohol consumption compared to only real-time use for Promillekoll.~      Study 2: The proportion of participants with risky use above recommended levels will decline~     faster in the group that receives the intervention first, in comparison to controls.~   "
75812|NCT02064985|"~     open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and~     safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in~     Chinese patients with stable coronary heart disease~   "
75824|NCT02064829|"~     The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel~     in female patients with metastatic or locally recurrent breast cancer. In addition, the~     study will compare the safety and tolerance of IG-001 and nab-paclitaxel during the~     bioequivalence 2-period crossover portion of the study. The study will also evaluate the~     long-term safety of IG-001 over repeated cycles, up to 4 additional cycles of~     administration.~   "
75825|NCT02064816|"~     This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase~     4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to~     a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in~     subjects with relapsing multiple sclerosis (RMS).~   "
77369|NCT02044666|"~     This study is intended to collect safety and effectiveness data on the Cook Micronized Small~     Intestinal Submucosa (SIS)~   "
75813|NCT02064972|"~     In consideration of the fact that the vascular endothelium has been shown to be a target of~     GvHD in early stage and that the count of CEC may represent a marker of endothelial damage,~     we want to evaluate the changes in CEC counts of patients affected by hematological~     disorders undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50~     patients affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be~     drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant),~     upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of~     GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients~     will also be checked for CEC at day + 28. CEC enumeration will be performed by using the~     CellSearch® System and a flowcytometry procedure.~      Through the conduct of this study, we expect to confirm our preliminary results on a larger~     series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and~     prognostic response to treatment of GvHD. The possibility of early identification of~     patients who do not respond to traditional treatments of GvHD, and for this reason at a~     higher risk of morbidity and mortality, may allow greater individualization of the~     therapeutic program, for example with the introduction as early as possible of alternative~     treatments. In addition, the identification of patients at higher risk of non-responsiveness~     to steroid treatment, would allow, through a closer monitoring, the early introduction of~     additional treatment before the development of resistance/refractoriness to treatment of~     GvHD.~      The present study takes the form of a prospective study. The primary endpoint is the~     identification and enumeration of CECs in peripheral blood of patients with hematological~     disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint~     is to define the prognostic and predictive value of the changes of CEC counts on the~     diagnosis of GvHD and response to treatment.~   "
75814|NCT02064959|"~     This randomized, prospective trial will study the effect of very early cooling in patients~     undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura~     followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters~     (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain~     normothermia.~      The primary objective is to determine if rapid induction of hypothermia prior to emergent~     craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow~     Outcome Scale-Extended (GOSE) at 6 months.~   "
75815|NCT02064946|"~     The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation~     regimen in reducing androgen deprivation therapy (ADT)-related side effects in older~     prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm,~     controlled clinical trial that will accrue 76 prostate cancer patients without severe bone~     loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of~     ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2)~     vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily~     multivitamin and calcium supplement.~   "
75816|NCT02064933|"~     Wiskott - Aldrich syndrome (WAS) is a rare serious medical condition that causes problems~     both with the immune system and with easy bruising and bleeding. The immune abnormalities~     cause patients with WAS to be very susceptible to infections. Depending on the specific type~     of primary immune deficiency diseases, there are effective treatments, including~     antibiotics, cellular therapy and gene therapy, but studies of large numbers of patients are~     needed to determine the full range of causes, natural history, or the best methods of~     treatment for long term success.~      This multicenter study combines retrospective, prospective and cross-sectional analyses of~     the transplant experiences for patients with WAS who have already received HCT since 1990,~     or who will undergo Hematopoietic cell transplant (HCT) during the study period. The~     retrospective and prospective portions of the study will address the impact of a number of~     pre and post-transplant factors on post-transplant disease correction and ultimate benefit~     from HCT and the cross-sectional portion of the study will assess the benefit of HCT 2 years~     post-HCT in consenting surviving patients.~   "
75817|NCT02064920|"~     This study aims to determine whether the Cogstate testing battery can detect improvements in~     cognitive function in participants with mild AD. The primary hypothesis is that the standard~     deviation associated with the change from baseline in average One Card Learning (OCL)~     repeated measurements after 12 weeks of donepezil treatment is =<0.1~   "
75818|NCT02064907|"~     The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD)~     of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the~     tongue and swallowed without water.~   "
75819|NCT02064894|"~     Pain management for children presenting to the emergency department (ED) with an injured~     limb is often under-treated, even though it is known that broken arms and legs cause~     moderate to severe pain. Further, children are less likely to receive appropriate pain~     medicine than adults with similar injuries. This study aims to improve the pain treatment of~     children who present to the ED with a suspected fracture, or broken bone or severe sprain.~     The investigators will compare the use of 3 different possible medication combinations~     (ibuprofen alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine~     which combination is the best at treating children's pain. The investigators also plan to~     verify the safety of using these different drugs to treat children's pain.~      The investigators strongly believe that children's pain should be optimally treated in the~     ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have~     both short and longterm effects on the child. It also generates unnecessary stress for both~     the child and their caregivers/parents. Given this knowledge, the investigators feel that~     their study has the potential to impact care provided in EDs, and improve pain management~     safely, for children.~   "
75820|NCT02064881|"~     The aim of this study is to evaluate the effect of metformin glycinate vs metformin~     hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized~     and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or~     metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed~     for 4 months.~      Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B,~     oxidized LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free~     fatty acids, fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of~     plasma will be measured at baseline and 4 months.~      Additionally, after a structured meal, the following parameters will be measured: glucose,~     insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months).~     Throughout the study adverse events will be documented.~   "
75821|NCT02064868|"~     This is a multinational, multicenter, randomized, open-label study to confirm and expand the~     efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30~     micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for~     Acute Heart Failure (AHF).~   "
75822|NCT02064855|"~     The purpose of this study is to evaluate fusion status and patient outcomes observed from~     use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the~     literature reported outcomes of spinal fusion using autograft with posterior stabilization.~   "
75826|NCT02064803|"~     The incidence of unresectable and obstructive gastric cancer patients ranges in the~     literature from 5 to 30 % . In such cases, gastro-entero anastomosis is traditionally~     performed and can improve the quality of life by relieving the symptoms of impaired oral~     intake without having a high surgical risk. Unfortunately, up to 25% of these patients may~     develop impaired gastric emptying syndrome. Gastric partitioning was originally described by~     Devine in 1925 as a method of antral exclusion and complete division of the stomach~     accompanied by a gastro-entero anastomosis in the proximal gastric pouch for the management~     of difficult duodenal ulcers. This procedure has been modified along the years and was~     adopted for the palliative treatment of gastric cancer. The advantages of the partitioning~     includes: better gastric emptying, avoidance of direct tumor invasion of the gastro-entero~     anastomosis, less contact between the ingested food and the tumor with less blood lost and~     improved survival. Retrospective not randomized studies have been published demonstrating~     the effectiveness of the procedure.~   "
75827|NCT02064790|"~     Although some studies show improvement of pain and associated effects of pain with off-label~     use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published~     evidence so far. We propose to complete a year-long prospective, observational study as a~     pilot to recruit 400 patients within the year and follow their pain level, function, and QOL~     measures for 16 weeks to determine whether it is feasible to continue studying this group in~     the future. We expect that pain, function, and quality of life will be improved in the group~     of patients who are given neuropathic agents as an adjunct to other conservative treatments~     compared to the expected 65% of patients with similar symptoms who are treated~     conservatively without neuropathic agents. We do not expect a statistically significant~     difference between the two neuropathic agents.~      Since these drugs are currently used off-label, there is limited empirical evidence~     regarding which agent is more efficacious compared to the other, and since their use in~     treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or~     the other of these agents has been based on likely compliance (medication needed twice a~     day, three times a day) or whether or not the patients' insurance will pay for one or the~     other. This study will be a first step to better assist practitioners in counselling their~     patients on use of these medications in radiculopathy, examining rates of discontinuation~     due to side effects and what effects these medications have on perceived pain, function and~     quality of life.~   "
75828|NCT02064777|"~     Our first aim is thus to investigate, retrospectively first and then prospectively, in de~     novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro~     metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and~     pharmacogenomics and its evolution according to the age and transplant delay. Our second aim~     is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM)~     such as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus~     concentration and a way to model and predict it without invasive tests in pediatric~     patients.~      The final objective should be then to implement these findings in a more individualized and~     comprehensive immunosuppression protocol and monitoring in order to maintain adequate and~     well-balanced immunosuppression (preventing graft rejection while avoiding acute and~     long-term side effects). This is particularly important for a pediatric population exposed~     throughout their life to immunosuppressants.~   "
75829|NCT02064764|"~     The purpose of this clinical study is to evaluate the feasibility of performing both renal~     nerve denervation and pulmonary vein isolation on the same patient with the intent of~     characterizing both safety and effectiveness in a paroxysmal and persistent atrial~     fibrillation population with hypertension. To assess safety, the study will measure the~     occurrence of a composite safety endpoint and, to assess effectiveness, the study will~     measure freedom of chronic treatment failure through a minimum of six months of follow-up.~   "
75830|NCT02064751|"~     The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing~     (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in~     patients receiving cardiac resynchronization therapy (CRT).~   "
75831|NCT02064738|"~     The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6~     fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal~     symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease~     (AERD).~   "
75832|NCT02064725|"~     This is an open label, multi-center, single arm phase II study. The study will investigate~     the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of~     patients with recurrent or persistent PrR-negative endometrial cancer.~   "
75833|NCT02064712|"~     The purpose of this study is to determine an optimal strategy to wean nasal continuous~     positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that~     babies that are taken off NCPAP at lower settings will need fewer total days on NCPAP than~     those babies taken off at higher settings.~   "
75834|NCT02064699|"~     Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high~     morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R +~     develop CMV. The number of available antiviral drugs is reduced and noticeable side effects~     (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of~     reduced doses that promote non-response to treatment and the emergence of resistance. In~     case of neutropenia, there are more an increased risk of secondary rejection due to the~     reduction of immunosuppressive treatment rendered necessary by the haematological reached.~      Rational use of these molecules is necessary with essential today as the optimal duration of~     prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection~     reported in.~   "
75850|NCT02064491|"~     The purpose of this study is to determine whether continuing erlotinib beyond disease~     progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR~     mutant disease or who have responded to EGFR TKI.~   "
75862|NCT02064335|"~     In this project the investigators like to develop a methodology to stimulate more physical~     activity in inactive diabetic persons by an adapted physical activity program. An~     individually oriented and medically adapted exercise plan will be set up. Participants will~     be stimulated to be physically active in the long term, even when the coaching has been~     finished.~      In a randomized controlled trial the health effects of the coaching are studied in the short~     and long term. This trial, in addition to a process evaluation by all stakeholders, gives~     more information about the implementation of the project in Flanders.~   "
75835|NCT02064686|"~     The goals : to develop and computerize equipment for measuring ITAE , compare the results~     with TAEP Itae study the possible relationship between different markers of inflammation:~     sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a~     bronchodilator in measuring the ITAE .~      It has designed a line of work studying the following aspects :~      1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30~     asthma and 30 volunteers .~      Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE~     and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.~      Three . ITAE measurement before and after the spirometry test , 20 patients , in stable~     phase will be measured before and after the ITAE spirometry .~      April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol ,~     20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen~     minutes after administration of salbutamol .~      May . Measurement in patients Itae a bronchial provocation test with methacholine was~     performed , 20 patients were measured and baseline Itae after administration of methacholine~     .~      6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients~     during an exacerbation , the ITAE be measured. Already in clinically stable measurement is~     repeated.~   "
75836|NCT02064673|"~     This is a prospective study to determine if the adjuvant use of Curcumin improves~     recurrence-free survival.~   "
75837|NCT02064660|"~     Myopia is widely one of the three commonly detected refractive errors. Myopia is usually~     managed by correction through glasses or contact lenses. Other alternative available include~     surgery, drugs and acupuncture. There are various therapeutic approaches and different~     points can be used in acupuncture treatment for myopia, such as auricular acupuncture,~     acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is~     largely unknown. Furthermore, little information exists regarding the effects and safety of~     acupuncture for degenerative myopia in children.~      The investigators aimed to assess the overall effectiveness, safety of periocular~     acupressure for children with myopia~      The hypotheses of this study are as follows:~      Periocular acupressure is effective for myopia progression delay.~      The study aims to include 56 participants.~   "
75838|NCT02064647|"~     Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated~     every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance~     delivery of insulin through pump therapy. In addition this real-time CGM data includes~     trend arrows which indicate when the blood glucose is rapidly falling or rising thus~     enabling the pump user to make immediate adjustments in insulin delivery to prevent~     subsequent low or high blood sugars. The trend arrows are displayed when the blood glucose~     is rapidly falling or rising. For example, if the glucose is increasing by 1-2 mmol/L over~     20 minutes, a single upward arrow alerts the pump wearer, who can then decide to give a~     bolus of insulin or increase the meal bolus. Should the glucose level be increasing at a~     rate greater than 2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could~     decide to give a larger bolus. The purpose of the bolus adjustment is to add insulin for the~     predicted rise in glucose to prevent or reduce subsequent hyperglycemia. Similarly, a~     decrease in the insulin bolus is advised if glucose levels are falling as evidenced by one~     or two downward arrows.~      However, effective strategies for adjusting insulin boluses based on CGM trend arrows are~     lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows~     using a standard 10-20% increase/decrease of the total original recommended bolus dose (10%~     for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose~     calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended~     bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the~     current blood glucose (if above or below target range), as well as the amount of active~     insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may~     overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use~     the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low~     acceptance and adherence by CGM users.~      The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM~     trend arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow~     Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/-~     (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool~     within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing,~     and more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool~     appears to have excellent uptake amongst the TIME Trial participants, with observations that~     there is continued usage of the tool throughout the 12 month study, and greater satisfaction~     with this component of CGM. However, the tool has not been systematically evaluated.~      The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its~     effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent,~     child/youth satisfaction, and ease of use of the tool based on self-report measures.~     Comparison will be made with the 10/20% bolus adjustment & also to no adjustments to meal~     boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead~     to more time spent within the target glucose range, this will have immediate clinical~     benefit for patients, including improved quality of life, and potentially a reduction in~     HbA1c and prevention of long-term complications.~   "
75839|NCT02064634|"~     This study investigates how gastrointestinal toxicity affects discontinuation of medication~     given to patients with osteoarthritis in routine clinical practice.~   "
75840|NCT02064621|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of~     Candesartan between free combination of Candesartan and Amlodipine and Candesartan~     monotherapy.~   "
75841|NCT02064608|"~     Patients with localised prostate cancer can be treated by radical prostatectomy (prostate~     gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed~     with high risk disease meaning they are more likely to suffer treatment failure, disease~     progression and mortality. To date little progress has been made towards identifying~     effective treatment strategies that might delay or prevent disease recurrence in this~     patient population. Better identification of patients at high risk of relapse and~     improvements in therapy are therefore research priorities.~      A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in~     the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and~     sends signals helping cancer cells to grow while controlling their energy use. Blocking the~     function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy~     supply to tumour cells leading to reduced cell growth and potentially slowing the~     progression of the disease.~      The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment~     given to patients with prostate cancer prior to radical prostatectomy. The feasibility,~     safety and tolerability of a short course of AZD2014 will also be assessed.~   "
75842|NCT02064595|"~     The objective of this research is to prospectively evaluate a group of patients with shaft~     compound fracture of the tibia, treated with a biplanar external fixator or locked~     intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and~     postoperative complications.~   "
75843|NCT02064582|"~     The study is being done to find out whether combining two FDA approved drugs along with~     radiation therapy for the treatment of high risk localized prostate cancer is safe and well~     tolerated.~   "
75844|NCT02064569|"~     The purpose of this study is to evaluate the safety and tolerability profile of ascending~     doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.~   "
75845|NCT02064556|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of~     Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine~     monotherapy.~   "
75846|NCT02064543|"~     The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons~     living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who~     are able to provide informed consent will participate in the assessments.~      Outcome variables include selected gait and balance parameters such as cadence, gait-cycle,~     stride-length, stride-velocity, turning duration, turning steps, postural sway and~     anticipatory postural control. These parameters will be measured by the portable inertial~     sensors developed by APDM® and the Zeno/GaitRite.~   "
75847|NCT02064530|"~     the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added~     to bupivacaine on TAP block in patients undergoing lower abdominal surgery.~   "
75848|NCT02064517|"~     Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium)~     allows to obtain a better forecast of preservation of the tooth without complication than~     the conventional technique with the creation of an apicale barrier in the MTA in 24 months.~   "
75849|NCT02064504|"~     GSK961081 is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule and is in development for the treatment of chronic~     obstructive pulmonary disease (COPD). This is a randomised, open-label, six-way crossover,~     single dose study. This study evaluates the drug delivery and systemic pharmacokinetics of~     GSK961081 following concurrent administration of GSK961081 and fluticasone furoate via dry~     powder inhaler (DPI) in comparison to GSK961081 DISKUS. There will be six treatment periods~     and 7 days washout period in the study. Subjects will attend the unit in the morning for~     dosing and will be resident until 12 hours post administration. All subjects will receive~     six treatments.~   "
75851|NCT02064478|"~     A bone anchored hearing system is used to improve hearing for patients with e.g.~     conductive/mixed hearing loss or single sided deafness.~      With this type of system, a titanium implant is installed in the temporal bone, where it~     osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached~     to the implants and penetrates the skin. The sound processor (hearing aid) is then connected~     to the abutment, and can be attached and removed by the patient via a snap-coupling. This~     type of system has been successfully implanted in more than 100.000 patients. Recently, a~     simplified surgical procedure, where no skin thinning around the abutment is made, was~     approved. The results after using this installation technique, here called soft tissue~     preservation, are the focus of this study.~      The objective of the study is to compare the outcomes after a surgical procedure with soft~     tissue preservation (test) and a surgery with soft tissue reduction (control) for placing~     Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness~     around the implant is less in the test group compared to the control group.~   "
75852|NCT02064465|"~     This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of~     lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed~     tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal~     numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or~     lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be~     collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours~     post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse~     events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days~     post-dose.~   "
75853|NCT02064452|"~     This study will experimentally evaluate an internet-based version of the Triple P Positive~     Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in~     an interactive, video-enriched, and personalized format with 3-levels of flexible dosage,~     and will compare it against usual community services. Thirty pediatric clinics involving 100~     practitioners in 9 counties across western Washington will be recruited and randomized to~     receive (a) access for their patients to the Triple P Online System and training in how to~     effectively promote TPOS and advise parents on their children's behavior problems or (b)~     Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate~     referral for services in the community.~   "
75854|NCT02064439|"~     This is a multicenter, randomized, double-blind, event-driven, superiority study for~     efficacy.~      Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism)~     who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial~   "
75855|NCT02064426|"~     Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934~     versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response~     and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg~     once daily.~   "
75856|NCT02064413|"~     To evaluate the safety and successful placement rate of Essure Model ESS310 device and any~     factors that may influence the successful placement rate of this device.~   "
75857|NCT02064400|"~     Little is currently known as to the predictive value of ultrasound in guiding the decision~     to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that~     patients' views and opinions regarding their medications may have upon this. In this study,~     patients with stable rheumatoid arthritis will undergo a simple examination of their joints~     to look for any swelling or tenderness followed by an ultrasound scan to look for joint~     inflammation. Half of the patients will also complete an interview to assess their views and~     opinions of arthritis drug treatment. The study will be completed in a single patient visit~     - no invasive tests will be performed, and no changes to treatment will be made.~      This study is being conducted as part of a Masters degree from Newcastle University. The~     results of this study will be used to inform the feasibility of inclusion of ultrasound~     assessment within the design of a future PhD study to investigate potential markers of~     remission in patients with rheumatoid arthritis.~   "
75858|NCT02064387|"~     This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the~     therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas~     that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be~     safely administered to subjects with MM and with BCMA positive malignancies at doses where~     target engagement can be demonstrated. This study will determine if adequate target~     engagement of BCMA receptors translates into clinical benefit for subjects with MM and BCMA~     positive lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and~     a Part 2 expansion phase for safety, tolerability, PK, PD, and clinical activity testing.~     The study will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or~     BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial~     will not exceed 5 milligram/kilogram(mg/kg).~   "
75859|NCT02064374|"~     This study will be a phase 1, open label, parallel group, three period crossover study to~     evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin~     and on the safety and tolerability of dolutegravir and metformin. Subjects will have a~     screening visit within 30 days prior to the first dose of study drug, three treatment~     periods, and a follow up visit 7-14 days after the last dose of study drug. Eligible~     subjects will be assigned to one of the two treatment cohorts. Subjects will receive~     metformin 500 milligram (mg) after every 12 hours (q12h) for 5 days in Period 1; metformin~     500 mg q12h plus dolutegravir 50 mg after every 24 hours (q24h) (Cohort 1) or 50 mg q12h~     (Cohort 2) for 7 days in Period 2; and metformin 500 mg q12h for 10 days in Period 3. There~     will be no washout periods between treatments. All doses of study drug will be taken~     following a meal. Safety evaluations will be collected during each period. Serial~     pharmacokinetic (PK) samples will be collected for metformin on the last day of each period~     and for dolutegravir on the last day of Period 2.~   "
75860|NCT02064361|"~     The purpose of this study is to determine the impact of high intensity,anaerobic exercise,~     in the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and~     subtype of circulating microparticles, complete blood counts, and the quantification of~     venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.~   "
75861|NCT02064348|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the effect of~     semaglutide on cardiac repolarisation in healthy subjects.~   "
75865|NCT02064296|"~     The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on~     patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is~     effective for FM because it functions as a desensitization therapy, which when applied~     repeatedly over multiple treatment sessions, gradually habituates the nervous system to~     continuing pain and sensory signaling.~   "
75866|NCT02064283|"~     This study will evaluate the feasibility of identifying changes in diffusion MRI~     characteristics of bone that correlates with response to therapy in men with metastatic~     prostate cancer.~   "
75867|NCT02064270|"~     The aim of this study is to assess the prevention of incision healing complications in~     patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated~     with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of~     care dressings.~   "
75868|NCT02064257|"~     A research project funded by the Australian Childhood Foundation (ACF) will be conducted in~     Australian facilities of the ACF to evaluate the effectiveness of the Listening Project~     Protocol (LPP) in children with a trauma history. The LPP is designed as a neural exercise~     to reduce auditory hypersensitivities, to improve auditory processing of speech, and to~     improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the~     neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic~     transfer function of the middle ear structures. The current study is being conducted to~     evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate~     changes in acoustic transfer function of the middle ears structures, auditory processing~     skills, physiological state regulation, and sensory symptoms.~   "
75869|NCT02064244|"~     Bedside ultrasonographic assessment of IVC size and IVC collapsibility index can be used to~     guide the management of patients with acute kidney injury with and without volume overload~     in the intensive care unit~   "
75870|NCT02064231|"~     To assess the functionality and safety of the test products and also assess the products~     ability to collect stool without interfering with the stoma.~   "
75871|NCT02064218|"~     First of all to evaluate the relationship between non-conventional biomarkers and essential~     hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood~     pressure control and non-conventional biomarkers in naive hypertensive patients~   "
75872|NCT02064205|"~     Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency~     of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that~     regulate satiety may play a role in weight management. Suppression of appetite may reduce~     energy intake, which in return may lead to body weight reduction. This study aims to verify~     the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight~     and overweight women.~   "
75873|NCT02064192|"~     The EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic~     Implantable Cardioverter Defibrillators (EU-CERT-ICD) is a modular research project to~     study the effectiveness of prophylactic ICDs in a prospective study, a retrospective~     registry, and meta-analyses of existing evidence on the subject.~   "
75874|NCT02064179|"~     The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects~     is routine in intensive care units around the country and world in children who have~     undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after~     repair. Most common protocols recommend heparin infusions after surgery with transition to~     oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart~     surgery requiring long-term antiplatelet therapy include those undergoing shunt placement~     for single-ventricle palliation or establishment of pulmonary blood flow, valve~     replacements, or coronary artery manipulation. Post-operative thrombosis after congenital~     heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in~     these patients is intended to prevent the potentially catastrophic consequences of~     thrombosis. However, there is no routine clinical assessment of the platelet inhibitory~     effect of aspirin; nor have there been any prospective studies to assess the effectiveness~     of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists~     to suggest that the first dose of aspirin transition from heparin infusion is either~     sufficient or insufficient in its antiplatelet effect.~      In this study, the investigators will evaluate the effectiveness of the first aspirin dose~     in its antiplatelet effects after surgery for congenital heart disease. Degree of~     antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping~     study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood~     hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most~     commonly used in patients at risk for bleeding or thrombosis and also to monitor~     antiplatelet therapies (such as aspirin).~      The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion~     after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and~     TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help~     support the current practice of empiric aspirin therapy to prevent post-operative thrombosis~     in children after congenital heart surgery.~   "
75875|NCT02064166|"~     Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative~     disorders characterized by abnormal accumulation of α-synuclein. There is no effective~     treatment that can slow down the disease progression and both disorders are associated with~     severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and~     memory in healthy and cognitively impaired non-diabetic adults.~      The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322)~     has shown that a single 40 international units dose of intranasal insulin improves~     visuospatial memory in diabetes and control subjects.~      This proposal includes randomized, double blinded, placebo-controlled trial of intranasal~     insulin (40 international units daily) in treatment of PD and MSA.~      The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the~     study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of~     cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of~     the cognitive scale ratings.~   "
75876|NCT02064153|"~     Hemodialysis (HD) is widely used treatment for end stage renal diseases (ESRD) patients. The~     chief aims of HD are solute and fluid removal. Decades of practice have improved HD care,~     but more can be done to improve morbidity and mortality. Enhancing toxin removal is an~     important consideration for improved patient outcomes. Also, decreasing the incidence of~     intra-dialytic hypotensive (IDH) episodes (dominant in Singapore patient cohort) can~     significantly reduce associated morbidities and mortality. A simple maneuver for clinicians~     is the dialysate temperature. Literature suggests that a lower dialysate temperature (35ºC)~     results in reduced hypotensive episodes by vasoconstriction. Conversely, higher dialysate~     temperature resulting in higher blood temperature decreases the peripheral resistance,~     leading to increased toxin removal, but may cause IDH episodes partly due to vasodilation.~     Optimal manipulation of the dialysate temperature is therefore primary handles to obtain the~     improved patient outcomes. In this study, the effect of dialysate temperature (cool vs. warm~     dialysate) on toxin removal will be studied. In both the interventions, outcome measure will~     be patient hemodynamic response and amount of toxins removed. The spent dialysate will be~     collected to study the quantum of toxin removed.~   "
75877|NCT02064140|"~     Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary~     infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the~     development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients~     remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment.~     Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation~     (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV~     are the development of respiratory muscle atrophy (due to disuse) and the need for high dose~     sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and~     respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes~     and prolonged MV.~      Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV~     decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics,~     and lowers consumption of sedatives. However potential disadvantages of supported~     ventilation include generation of too high tidal volumes, especially in patients with high~     respiratory drive. A previous study in healthy subjects has shown that titration of~     neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while~     maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported~     MV with adequate tidal volumes, in patients with high respiratory drive.~   "
75878|NCT02064127|"~     The investigators aim to evaluate in a retrospective study the performance of the Swiss~     Emergency Triage Scale to identify at the door of the Emergency Department patients~     requiring emergent intervention.~   "
75879|NCT02064114|"~     Study hypothesis:~      Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an~     obesity treatment after atrial fibrillation ablation.~      Study design:~      A prospective randomized, open-label clinical trial.~   "
75880|NCT02064101|"~     Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can~     be used to effectively test correct pedicle screw placement in the lumbar and thoracic~     vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a~     response the screw is correctly placed in the bone. If there is a response with less than~     6mA there is a strong likelihood of a breach of the pedicle wall or invasion of the spinal~     canal. Typically this triggered EMG stimulation is done after all the screws have been~     placed with a ball-tipped probe and is paired with intraoperative fluoroscopy to ensure~     correct placement of the screws. Another method of testing the current for each screw is~     with a powered screwdriver, which can stimulate and give a reading as the surgeon places~     each screw. Both of these methods are currently used by surgeons, however the powered~     screwdriver has been found to be a faster method. The investigator's aim with this study is~     to compare these two methods of testing triggered EMG values. The investigators plan on~     doing this by testing each screw with both the ball-tipped probe and the powered~     screwdriver, in order to see if there are any statistically significant differences between~     the readings.~   "
75881|NCT02064088|"~     The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion~     between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches~     the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral~     abdominal wall. The transversus abdominis plane block has shown promise for perioperative~     analgesia, but data on the optimal dose regimen are limited.Following previous research of~     optimal dose of local anesthesic solution, the investigators aim to evaluate if a volume~     effect would lead to a better diffusion of the local anesthesic solution to the overall~     nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology~     of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for small volume group or 0,4 ml/kg~     of 0,1% levobupivacaine for high volume group).With the same dose of levobupivacaine, this~     study aims to assess the impact of volume effect on analgesia efficiency as well as the~     security as after ultrasound TAP block on one to five years' old children who undergo a~     peritoneal-vaginal duct surgery.~   "
75882|NCT02064075|"~     Purpose:~      - Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect~     the clinical outcome. The purpose of this study is to determine whether crystalloid~     (Lactated Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more~     effective in the treatment of subarachnoid hemorrhage (SAH)~      Treatment:~      - Patients are randomly divided into two groups. Depending on the blood pressure of the~     patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily~     as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg~     hydroxyethyl starch solution daily.~      Measurements:~        -  Neurological status of patients will be determined by the NIH Stoke Scale Score and the~          Glasgow Coma Scale (GCS) on a daily basis.~        -  The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow~          Outcome Scale (GOS) 14 and 30 days following admission to our clinic.~      Hypothesis:~      -The prevalence of vasospasms, the mortality rate and the medium-term quality of life~     following subarachnoid hemorrhage is improved if patients are treated with intravenous~     colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.~   "
75883|NCT02064062|"~     This study is looking at a new treatment, using the patient's own stem cells (the repair~     cells of the body), to see whether this can help reduce pain and promote healing of the~     Achilles tendon, without side effects.~   "
75884|NCT02064049|"~     The purpose of the study is to assess how feasible it is to treat and prevent the~     transmission of Hepatitis C in the prison setting to achieve substantial reductions in the~     incidence and prevalence of Hepatitis C.~      It is hypothesised that a rapid scale-up of Hepatitis C Virus (HCV) treatment with~     interferon-free Direct Acting Anti-virals (DAAs) in prison inmates will achieve a >50%~     reduction in the incidence of HCV infection over a two year period in the prison setting.~   "
75885|NCT02064036|"~     We hypothesize that SBRT as a boost to the prostate following whole pelvic intensity~     modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men~     with unfavorable intermediate and high risk localized prostate cancer.~      Our primary objective is to assess the feasibility and safety of a treatment strategy~     incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant,~     concurrent, and adjuvant androgen deprivation for a total of 28 months for men with~     unfavorable intermediate or high risk localized prostate cancer.~   "
77370|NCT02044653|"~     The primary objective of study is~        -  Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2~        -  Part B : To evaluate the proof of concept (POC) of GX-E2~   "
75887|NCT02064010|"~     This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects~     with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a~     randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing~     levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of~     90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and~     safety profiles of SNC-102 in the target population.~   "
75888|NCT02063997|"~     The purpose of this study is to determine whether arhalofenate is effective in preventing~     flares and reducing serum uric acid in gout patients.~   "
75889|NCT02063984|"~     This study will continue research designed to improve treatment outcomes for adolescent~     substance use disorders by integrating neuroscience- and behaviorally-based treatments. In~     particular, this project will be the first to evaluate whether Working Memory Training can~     enhance cognitive function and reduce impulsive decision making to improve abstinence~     outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a~     new method for intervening with those who do not respond to their first-line treatment.~   "
75890|NCT02063971|"~     The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082~     soothing cream used just after injection procedure and also the tolerance and the efficacy~     of the F#841-020 anti-age cream on aging parameters compared to baseline and to the~     F#1374-002 placebo cream (comparison within subjects - half face method) to identify~     additional benefits delivered by the product compared to a cosmetic procedure.~   "
75891|NCT02063958|"~     Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in~     combination with everolimus.~   "
75892|NCT02063945|"~     Attention Deficit/Hyperactivity Disorder (ADHD) is one the most prevalent mental disorders~     among children and adolescents, with a prevalence of 5% in western culture. The basics of~     the disorder: inattentive and hyperactive/impulsive behaviors that manifest in a variety of~     settings causing a dysfunction in everyday life. ADHD can be subdivided into three~     sub-types: predominantly inattentive, predominantly hyperactive/impulsive or combined type.~     Common co-morbidities of ADHD are disruptive disorders; Oppositional defiant disorder (ODD)~     being the major one with about half of children with the combined sub-type ADHD and about a~     quarter of children with the predominantly inattentive also suffering from ODD. Conduct~     disorder is a co-morbidity for about a quarter of children with the combined sub-type ADHD.~     The co-occurrence of these disorders is thought to have a negative effect on the outcome of~     both of them.~      Methylphenidate (MPH), short or long acting, is the mainstay of medical treatment for ADHD~     patients, it's efficacy proven in a variety of studies. It should be noted that MPH has also~     been proven to have a beneficial effect on children with disruptive behaviors. For children~     with disruptive disorders Risperidone is the mainstay of medical treatment, and has been~     proven in clinical trials.~      To the best of their knowledge, a head to head study comparing these two drugs for the~     treatment of pediatric patients with ADHD and co-morbidity of disruptive disorders was never~     done before. The investigators aim is to examine the efficacy and tolerability of MPH vs.~     Risperidone in this population. In addition, the investigators will apply DSM5's cross~     cutting symptom measures scales is order to further define this unique subset of patients.~      Disruptive mood dysregulation disorder (DMDD) is a new diagnosis in the latest version of~     the diagnostic and statistical manual (DSM5). It's main features: sever recurrent temper~     outbursts that are inconsistent with developmental level and occur on average three times a~     week, the outbursts occur in at least two settings and the mood between outbursts is~     irritable or angry. This diagnosis is in the differential diagnosis of ADHD with disruptive~     disorders.~   "
75893|NCT02063932|"~     There might be a correlation between gastric mucosal microbiome and mucosal pattern~     visualized by confocal laser endomicroscope.~   "
75894|NCT02063919|"~     The purpose of this study is to determine whether an association between endomicroscopic~     pattern and colorectal mucosal microbiome exists.~   "
75895|NCT02063906|"~     Recently, the investigators face on the edges for treatment decision to decide adjuvant~     systemic treatment, especially for patients who show discordance between stage and tumor~     biology. The aim of this study was to compare the prognostic relevance of the TNM staging~     system and intrinsic subtype in breast cancer patients who received curative surgery.~   "
75896|NCT02063893|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinctmurine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
75897|NCT02063880|"~     Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children~     will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy~     (7-14 days). This trial will be unblinded.~      Population: Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve~     ≤ 12 years of age.~      Sample size: 360 children will be randomized (180 per arm).~      Treatment: All infants will be treated with ART according to World Health Organization (WHO)~     and Kenyan national guidelines.~      Study duration: Enrollment into the study will occur over the course of 36-48 months and~     each infant will be routinely followed for a maximum of 6 months.~      Study site: Kenyan hospitals.~      Primary hypothesis:~      HIV-1 infected children hospitalized with severe co-infection either may be unsalvageable~     due to too far advanced immunosuppression/co-infection or may benefit from urgent ART.~      Secondary hypotheses:~      Urgent ART during an acute infection could potentially result in increased risk of immune~     reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.~      Specific aims:~        1. To compare the 6 month all-cause mortality rate, incidence of immune reconstitution~          inflammatory syndrome (IRIS), and incidence of drug toxicity in HIV-1 infected children~          (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent~          (<48 hours) versus early ART (7-14 days).~        2. To determine co-factors for mortality, IRIS, and drug toxicity. Potential cofactors~          will include: baseline weight-for-age, height-for-age, weight-for-height (Z-scores),~          CD4, HIV-1 RNA, type of co-infection, age, rate of viral load and CD4 change following~          ART, immune activation markers, pathogen and HIV-1 specific immune responses.~      Secondary aim: To determine etiologies of IRIS and to compare immune reconstitution to HIV,~     TB, EBV and CMV following ART overall and in each trial arm.~   "
75898|NCT02063867|"~     The ABATE Infection Project is a cluster randomized trial of hospitals to compare two~     quality improvement strategies to reduce multi-drug resistant organisms and~     healthcare-associated infections in non-critical care units. The two strategies to be~     evaluated are:~        -  Arm 1: Routine Care Routine policy for showering/bathing~        -  Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing~          for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen~      Note that enrolled subjects represents 53 individual HCA Hospitals (representing ~190~     non-critical care units) that have been randomized.~   "
77371|NCT02044640|"~     This is a retrospective chart review meant to identify any factors that are correlated with~     and may possibly lead to postoperative nausea and vomiting in order to predict need for~     longer hospital stays and potentially decrease postoperative nausea and vomiting.~   "
75899|NCT02063854|"~     The present phase II/III, multicenter, randomized, double-blind, parallel group comparative~     study is designed to evaluate the efficacy and safety of oral administration of~     NE-58095NF(New formulation) tablets for 12 months in patients with involutional~     osteoporosis. For this study, patients receiving oral NE-58095 2.5-mg tablets once daily for~     12 months are set as the control group.~   "
75900|NCT02063841|"~     ERCP is associated with radiation exposure to the endoscopist and staff, which may be~     significant at high volume programs despite the use of lead aprons. We hypothesize that~     draping of the fluoroscopy image intensifier may significantly reduce staff radiation~     exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable)~     principle.~   "
75901|NCT02063828|"~     The purpose of this research study is to compare the effects of music and different levels~     of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.~   "
75902|NCT02063815|"~     The purpose of this randomized clinical trial was to compare caries prevention of a~     conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and~     fissures over a one year period in a high caries children group. Additionally the~     concentration of Fluoride in saliva was evaluated.~   "
75903|NCT02063802|"~     The purpose of this clinical trial is to examine the effects of conjugated linoleic acid~     (CLA) vs metformin along with an intervention program with healthy habits on body~     composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular~     and genetic changes in obese children.~      Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass~     index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.~   "
75904|NCT02063789|"~     Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined~     the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune~     diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared~     to Ig 5% because it is expected the reduced hospitalization/treatment duration and less~     adverse events related to volume overload.~   "
75905|NCT02063776|"~     Children on conventional haemodialysis (HD) die of heart disease. Also, they can be~     malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves~     better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and~     children show improved growth, but mechanisms are not understood.~      We will follow children in the UK and Europe to compare HDF and HD. We will monitor growth,~     heart and blood vessel scans, blood markers and quality of life. If the 3H~     (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may~     be adopted as the preferred type of dialysis in children.~   "
75906|NCT02063763|"~     This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and~     Romiplostim as bridge therapy for splenectomy in adult patients with primary immune~     thrombocytopenia.~   "
75907|NCT02063750|"~     Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in~     patients with fibromyalgia (FM).~      Material and Method: Sixty FM patients were randomized into two groups: an intervention~     group (IG), in which patients performed muscle strength exercises using the Swiss ball, and~     a stretching group (SG), in which patients performed stretching exercises. All patients~     participated in 40-minute training sessions three times per week for 12 weeks. The IG~     performed the following eight strengthening exercises using a Swiss ball: lateral rise,~     simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell~     row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle~     groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for~     pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ)~     to evaluate disease impact, and short form health survey (SF-36) to assess quality of life.~     All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of~     training. The assessor was blind to patient allocation.~   "
75908|NCT02063737|"~     Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using~     text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms,~     Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of~     Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that~     can improve alertness during shift work.~      Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in~     real-time at the start and during shift work reduces worker perceived sleepiness and fatigue~     at the end of shift work.~   "
75909|NCT02063724|"~     The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1~     vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants~     will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without~     trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,~     laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine~     administration.~   "
75910|NCT02063711|"~     Prenatal yoga has become a popular means of exercise during pregnancy.~   "
75911|NCT02063698|"~     This randomized pilot clinical trial studies whether auranofin will relieve pain following~     paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is~     a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being~     studied to see if it will decrease pain following paclitaxel.~   "
75922|NCT02063555|"~     This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study~     of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV~     negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are~     to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine~     at different dose levels, ranging from 0.1 to 1 mg.~   "
75923|NCT02063542|"~     Previous study demonstrated that the condition of central cholinergic nerve is important for~     the postoperative cognitive dysfunction. In present study investigators hypothesized that~     the acetylcholine concentration in the cerebral spinal fluid is associated to the~     postoperative cognitive changes in aged patients undergoing osteopathic surgery.~   "
76407|NCT02057211|"~     This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to~     preserve insulin production and beta-cell mass in recently diagnosed patients with type 1~     diabetes mellitus. The hypothesis to be tested is that an increased number of circulating~     mesenchymal stem cells will provide immune modulatory properties, and thereby stop the~     immune process in islets causing progressive beta-cell death.~   "
75912|NCT02063685|"~     Recently, the availability of R has substantially changed therapeutic approach to FL~     patients, since its combination with chemotherapy has improved response rates, progression~     free survival (PFS) and overall survival (OS). Based on the results of recently completed~     randomized studies the standard treatment for patients with FL should consist of an initial~     therapy with R-CHOP combination followed by two-year maintenance with R. Although results of~     randomized trials confirmed that this approach results in an improved patients' outcome and~     made a step forward in the management of patients with FL, one important question that can~     be raised is if this approach is really needed for all patients with FL or if some of them~     could benefit from a reduced intensity treatment achieving the same results in terms of~     outcome and survival . This question is of particular interest for newly diagnosed patients~     for whom maintenance does not affect OS.~      More recent data demonstrated that the outcome of patients with FL can be further predicted~     by evaluating the quality of response to therapy studying minimal residual disease (MRD).~     This project addresses the objective of evaluating if combining clinical response assessed~     on FDG-PET scan and molecular response measured through MRD detection could permit to single~     out groups of patients at different risk of progression and to consequently modulate~     maintenance therapies, with the aim to provide clinicians a more rational use of the~     available diagnostic and therapeutic resources.~   "
75913|NCT02063672|"~     To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of~     femoropopliteal artery (SFA) in-stent restenosis (ISR).~   "
75914|NCT02063659|"~     The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on~     the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid~     (5-HIAA) levels.~   "
75915|NCT02063646|"~     Several preliminary studies have shown that diet can have beneficial effects on cognitive~     decline. Among food shown to have such effects are some polyphenols from selected~     botanicals.~      Preclinical studies have concluded that polyphenols play a role in moderation of oxidative~     stress and inflammation, increased neuronal signaling, and improved metabolic function among~     other effects. Noteworthy, a positive and statistically significant association between the~     midlife level of polyphenol intake and cognitive function assessed 13 years later was found~     in a cohort of 2574 adults.~      Several mechanisms may be involved in these positive effects of food polyphenols on~     cognitive function in older adults: experimental studies suggest that polyphenols display~     neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and~     inducing neurogenesis, and might prevent age-related damage to the central nervous system~     through their antioxidant and anti-inflammatory activities.~      Based on these promising results, a food supplement from botanicals offering complementary~     polyphenol profile was developed. This food supplement is aimed to aid at maintenance of~     cognitive function in older adults.~   "
75916|NCT02063633|"~     Technologic advances in the field of radiation oncology have made in possible to deliver a~     highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid~     implementation of these novel techniques is often a reduction in the radiation margins,~     which reinforces the importance of accurate target delineation, and reduces the side effect~     of therapy.~      F-18 FDG PET/CT is widely used in oncology, including complete whole body staging, restaging~     and monitoring of tumor response in different types of cancers. As to non-oncology~     application, inflammation in almost any tissue will result in increased FDG accumulation.~     However, the normal tissue with sparing radiation may show subtle change, and would be~     difficult to be detected. FDG PET/CT was limited in the spatial resolution of 5 mm and low~     FDG-avid disease. To be evaluation of the interval change of metabolic response before and~     after radiotherapy of thoracic malignancies, we plan to initiate a prospective study trail~     the takes advantages of recent technical advances of technique in 4-dimensional PET/CT (4-D~     PET/CT) with respiratory gating system.~      Respiratory motion creates artifacts in PET and PET/CT images, and can alter diagnosis. The~     tumor edge would be blurred due to respiratory movement, and be underestimated the uptake~     value. Also, semi-quantitative measurement, standard uptake value (SUV), combined with~     parameters such as the lesion site and shape, which is commonly used to make the final~     assessment of disease would be mis-estimated.~      The study aims to investigate the correlation of 4-D PET/CT with respiratory gating methods~     and free breathing PET/CT when processing primary thoracic malignancy and normal tissue~     effect.~   "
75917|NCT02063620|"~     IVRA can be performed with many local anesthetics and adjuvant agents. In our study we~     planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus~     ketamine.~   "
75918|NCT02063607|"~     This is an open label, dose ranging, phase1a/1b clinical trial to study the safety,~     Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy~     volunteers and antiviral activity of once weekly Peglamda administration in combination with~     daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the~     study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and~     safety in Hepatitis C naive patients.~   "
75919|NCT02063594|"~     This is a randomized, double-blind, single dose, dose-escalation study to evaluate the~     safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection)~     administered intravenously to healthy volunteers. In addition, computed tomography (CT)~     scans will be acquired to measure radiographic density in regions of interest (ROI) at times~     from 3-5 hours and up to 72 hours following NCTX administration.~   "
75920|NCT02063581|"~     This Phase I, open-label, randomized, 2-period crossover study was designed to determine the~     relative bioavailability of ipatasertib administered as capsule and tablet formulations to~     healthy adult volunteers. Participants will be randomized to one of two treatment sequences~     to receive a single oral administration of ipatasertib in tablet or capsule formulation~     followed, after a washout period, by a single oral administration of ipatasertib in the~     second formulation. Pharmacokinetics will be assessed, and standard physical and clinical~     evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.~   "
75921|NCT02063568|"~     The purpose of this study is to evaluate the differences in blood clotting seen in healthy~     patients given two different doses of oxytocin following cesarean delivery. The secondary~     objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and~     differences in blood loss with the two separate doses of oxytocin.~   "
75924|NCT02063529|"~     PURPOSE:~      A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with~     FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS~     wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary~     aim is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus~     Cetuximab targeted therapy regimen in this patient population.~      Secondary aims include determination of objective response rate, progression free survival,~     quality of life and time to recurrence for patients undergoing complete resection and/or~     ablation of liver.~   "
75925|NCT02063516|"~     To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and~     Proseal LMA) and to observe any associated complications.~   "
75926|NCT02063503|"~     There is a consensus that exercise therapy should be used as a therapy approach in CLBP but~     little consensus has been reached about the preferential type of therapy. There occurs to be~     a wash out effect because of the heterogeneous character of CLBP patients. Therefore there~     is a need for the development of CPR's. Objectives for this trial are first, the derivation~     of clinical prediction rules (CPR) to predict treatment response to three forms of exercise~     therapy for patients with nonspecific chronic low back pain (CLBP). Secondly, to validate a~     clinical prediction rule for the three forms of exercise therapy for patients with~     nonspecific CLBP.~      The study design is a Randomized controlled trial. Patients with non-specific low back pain~     of more than three months duration are recruited at the Antwerp University Hospital. After~     examination patients are randomly assigned to one of three intervention groups: motor~     control therapy, general active exercise therapy and isometric training therapy. All~     patients will undergo eighteen treatment sessions during nine weeks. Measurements will be~     taken at baseline, nine weeks, six months and at one year. The primary outcome used is the~     Modified Oswestry Disability Questionnaire. For each type of exercise therapy a clinical~     prediction rule will be derived and validated. For validation the CPR will be applied to~     divide each treatment group into two subgroups (matched and unmatched therapy) using the~     baseline measurements. We predict a better therapy effect for matched therapy.~      Never before a RCT design was performed for the development of a CPR for exercise therapy in~     CLBP patients. Only one CPR was described in a single arm design for motor control therapy~     in sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be~     included in both the derivation and validation phase.~   "
75927|NCT02063490|"~     The study aim is to test the efficacy of one-year nurse-led interventions to improve the~     medication intake behaviour of chronic dialysis patients. The investigators hypothesis is~     the interventions leading to a 15% mean increase in intake, compared to standard care.~   "
75928|NCT02063477|"~     The objective of the study is to evaluate the effect of consumption of a food supplement~     rich in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of~     people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin®~     consumption on markers involved in the development of hypertension, and endothelial function~     in key enzymes that regulate blood pressure, inflammation and oxidation are considered.~     Also, try to advance the understanding of the molecular mechanisms that regulate blood~     pressure.~   "
75929|NCT02063464|"~     Background:~        -  Monocytes are a type of white blood cell found in human blood. They help the immune~          system. Researchers have found that monocytes taken from the blood of healthy people~          can kill tumor cells. Now they want to know if monocytes taken from the blood of people~          with ovarian cancer can kill tumor cells.~        -  In addition, native host anti-tumor cell mediated immune mechanisms may play a role in~          clinical outcome of epithelial ovarian cancer; data indicate that the presence of~          intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced~          ovarian cancer. Furthermore, non-cellular components in the blood, such as exosomes,~          may influence outcome.~      Objective:~      - To see if monocytes taken from the blood of people with ovarian cancer can kill tumor~     cells.~      Eligibility:~      - Women 18 years and older with ovarian cancer.~      Design:~        -  Participants will be screened with:~        -  Medical history and physical exam.~        -  Blood tests.~        -  CT scan of the chest, abdomen, and pelvis and/or an MRI. For these scans, they will lie~          in a machine that takes pictures of their body.~        -  A small amount of blood (two tubes) will be collected by needle during one visit.~   "
75930|NCT02063451|"~     Obesity has reached epidemic levels in the United States, and is on the rise in many~     industrialized nations. The rate of recidivism for long-term weight loss is substantial and~     presents a critical problem given the importance of obesity as a modifiable risk factor for~     diseases like type 2 diabetes. Further, the comorbidity of depression with diseases like~     obesity, type 2 diabetes, and cardiovascular disease suggest that there may be an underlying~     shared biology for diseases of metabolic dysfunction and emotional dysregulation. The shared~     biology of these diseases may actually promote the precipitation and exacerbation of~     comorbid conditions, impacting the success of treatment. Endogenous opioid systems regulate~     a number of physiological and psychological processes including mood, energy management, and~     reward. Endogenous opioid µ-receptor-mediated reward processing is thought to be involved~     both in the short-term control of eating and hedonic food consumption, based on data in~     animal models. The present proposal will examine the function of the µ-opioid receptor (MOR)~     system in lean and obese human volunteers following an overnight fast and the change in~     µ-opioid receptor occupancy (i.e., endogenous opioid release) following the consumption of a~     standardized meal using PET imaging with the µ-selective radiotracer [11C]carfentanil. The~     obese individuals will be retested in the fasting and fed state following a 15% weight loss~     with a Very Low Calorie Diet. Further, the investigators will evaluate the function of the~     MOR system within the context of the individual's metabolic and psychological profile~     including aspects of mood and inhibitory control. This information will provide the~     neurobiological bases to develop novel avenues of intervention based on individual~     variations in central mechanisms associated with motivational systems and appetite and their~     potential role in weight regain.~      The investigators hypothesize that overeating in chronically obese individuals will be~     associated with a dysregulation of MOR system function, manifested by reductions in baseline~     MOR availability (binding potential, BP) in limbic and reward circuitry, and lower release~     of endogenous opioids after a standard meal, compared to lean volunteers. The latter is~     observed as acute reductions in the BP measure after meal ingestion.~   "
75931|NCT02063438|"~     The purpose of this study is to examine pain associated with thoracotomy (incision made~     during surgery to obtain access to your thoracic cavity) and how the closure technique may~     influence postoperative pain. Two types of routinely selected thoracotomy closure techniques~     will be examined; pericostal and intracostal sutures. The investigators hypothesize that~     intracostal sutures will result in less postoperative and chronic pain as a result of less~     compression of the intercostal nerve.~   "
75932|NCT02063425|"~     The objective of this study is to better characterize the mechanisms of action of fluoxetine~     in motor recovery and more specifically to identify the neurophysiological substrate~     underlying fluoxetine-induced motor recovery in stroke.~      In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to~     assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and~     integrity.~   "
75933|NCT02063412|"~     The objective of this study is to compare the possible time savings from reduction of~     nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus~     traditional intravenous chemotherapy in the Hong Kong public hospital setting.~   "
75934|NCT02063399|"~     The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using~     plasma Epstein-Barr virus DNA analysis would result in the down-staging of the NPC cases in~     asymptomatic individuals.~   "
75936|NCT02063373|"~     Treatment: five intro-articular Hyaluronic Acid injection~      Assessment has two parts, that are as follow:~        1. Postural stability and risk of fall assessment using Biodex stability index and Timed~          up and Go test~        2. Gait and stair climbing assessment using Vicon motion capture system synchronized with~          four force plates.~      For knee OA subjects, assessment was done in week one or before injection; and for healthy~     controls one assessment was performed.~   "
75937|NCT02063360|"~     The purpose of this study is to determine if there is an interaction in healthy subjects~     taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.~   "
75938|NCT02063347|"~     Both clinical and experimental studies demonstrate the importance of the pre-existing, ie~     innate collateral supply in different vascular regions. Furthermore, pathophysiological~     considerations and experimental data imply an important role for the association of~     collateral function between different vascular regions.~      STUDY HYPOTHESES 1. In the absence of atherosclerotic stenoses, there is a direct~     association between the collateral function in the coronary, renal and peripheral~     circulation. 2. The increase in plasma renin in response to a unilateral main renal artery~     balloon occlusion is inversely related to its functional collateral supply. 3. The decrease~     in renal vein oxygen saturation in response to a unilateral main renal artery occlusion is~     inversely related to its functional collateral supply.~   "
75939|NCT02063334|"~     The purpose of the study is to investigate whether a high-dose vitamin D3 oral bolus (2000~     micrograms) produces marked vitamin D receptor target gene expression response and whether~     there is large inter-individual variation.~   "
75940|NCT02063321|"~     The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients~     with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology~     survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of~     diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and~     identification of prognostic factors leading to development of DME.~   "
75941|NCT02063308|"~     By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the~     blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's~     disease who take OAA for one month have any side-effects.~   "
75942|NCT02063295|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of~     beloranib in obese subjects with hypothalamic injury.~   "
75943|NCT02063282|"~     The investigators hypothesize that development of symptoms characteristic of Clostridium~     difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of~     non carriers and expect to find risk factors for development of symptomatic clostridium~     difficile.~   "
75944|NCT02063269|"~     Butyrylcholinesterase (BuChE) activity is increasing in Alzheimer Disease (AD) process (Lane~     et al., 2006). BuChE wild type has stronger butyrylcholine esterase activity than BuChE K~     variant allele and this strong activity can affect AD brain negatively by choline depletion.~     Rivastigmine has unique dual action - acetylcholine esterase inhibition and butyrylcholine~     esterase inhibition. Therefore, rivastigmine can lower serum butyrylcholine esterase~     activity and delay functional decrease of Fluorodeoxyglucose positron emission tomography~     (FDG PET) images in AD patients with BuChE wild type allele by strong BuChE inhibition.~      It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD.~     Therefore, we will try to find the different changes of serum butyrylcholine esterase~     activity by ELISA and functional and structural changes of brain between BuChE wild type and~     K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.~        1. Primary objective:~             1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging~             2. the mean changes of serum BuChE activity between BuChE wild type and K-variant~               type.~        2. Secondary objectives:~             1. the mean changes of cortical thickness in brain MRI~             2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale~               (ADAS-cog)~             3. the cognitive changes in Mini-Mental State Exam (MMSE)~             4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities~               of Daily Living (ADCS-ADL)~             5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)~             6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes~               (CDR-SB) between BuChE wild type and K-variant type.~   "
75945|NCT02063256|"~     Setting. Outpatient fertility clinic.~      Aim. Investigate if a modification in nutritional habits may improve in the short term the~     qualities of human sperm, testing two hypothesis:~      i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)~      OR~      ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA~     may affect beneficially sperm parameters.~      Population. N. 100 hypofertile male subjects attending a fertility clinic.~      Type of study. Interventional study. No drugs or pharmacologic supplementation will be~     required nor allowed.~      Two different type of intervention are scheduled:~        -  Supplementation to western style diet with nuts, naturally rich in PUFA~        -  Diet modification increasing intake of PUFA-rich foods and cutting the consumption of~          food rich in saturated fats.~      Protocol~        -  Baseline visit and recruiting.~        -  Informed consent~        -  Randomized allocation to treatment group in a 1: 1 manner~      Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of~     intervention.~      Phases:~        -  i) basal~        -  ii) after 15 weeks That interval is chosen because encompasses an entire~          spermatogenesis cycle.~      Outcomes. Primary~        -  sperm count, concentration,morphology and mobility.~      Secondary:~        -  serum folate assay,~        -  plasma PUFA (ALA, EPA, DHA) assay,~        -  body weight and BMI variation~      Statistics. A comparison for all sperm parameters (count,concentration,morphologic~     abnormalities, mobility) will be carried out by an analysis within groups and within~     patient.~   "
75946|NCT02063243|"~     This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with~     a argon gas based device in treating keloids and hypertrophic scars in population consisting~     of all Fitzpatrick skin type patients~   "
75947|NCT02063230|"~     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,~     ARRY-142886) in patients with hepatic impairment and healthy subjects.~   "
75948|NCT02063217|"~     The purpose of this study is to change the concentration of amyloid-beta in human~     cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.~   "
75949|NCT02063204|"~     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,~     ARRY-142886) in subjects with renal impairment and healthy subjects~   "
76045|NCT02061943|"~     This is a study of patients with spasmodic dysphonia to determine how best to measure the~     severity of the disorder in patients. It addresses which characteristics of speech are the~     best indicator of whether or not a particular treatment has benefited a person with~     spasmodic dysphonia. We hope to recruit 20 participants each at 2 different centers. The~     evaluation for each participant will be done on a two visits, one just before and another~     several weeks after treatment.~   "
75950|NCT02063191|"~     This is a single center, non-randomized, unblinded study of patients who are followed at~     Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated~     diagnostic electrophysiology (EP) study with or without ablation. During the procedure,~     events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during~     the course of the case will be saved electronically and analyzed offline. The stored data~     will be evaluated off-line for changes in activation timing of the near and far field~     ventricular signals of the stored events.~      This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle~     branch block can change activation timing compared to baseline sinus rhythm. If no~     significant activation change is seen, then this finding can be used as a basis to~     distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination~     methods.~   "
75951|NCT02063178|"~     Purpose: This study aims to take the procedural and research-based lessons learned from a~     pilot weight loss intervention (IRB # 13-02563-XP), conducted by The University of Tennessee~     Health Science Center in 2013, and apply them to the current study of 204 active duty~     military personnel. The pilot study translated and tailored the Look Ahead weight loss~     intervention to an overweight/obese active duty U.S. Air Force population, while~     accommodating the lifestyle and environment that is unique to military members and evaluate~     materials and procedures used.~      Rationale: Being overweight is now by far the leading medical reason for rejection in the~     military. Unfortunately, the impact of weight problems on the military does not stop with~     those turned away from military service. From 1998 to 2008, the Armed Forces Health~     Surveillance Center reported the percent of active military members who experienced medical~     encounters for overweight or obesity significantly increased. The estimated total days of~     work lost from absenteeism associated with active-duty personnel who are overweight or obese~     was 658,000. Using Department of Defense (DOD) estimates of average daily based, it was~     estimated that overweight and obesity costs the DOD $103 million dollars in health care~     costs annually. Note this estimate is for active duty personnel only. Furthermore, obesity~     is a major cause for the discharge of uniformed personnel.~      The current study is inspired by the successful Look Ahead trial, a behavioral science~     obesity intervention treatment program that included: a collaborative approach, education,~     behavioral support, and motivational interviewing. The unique nature of this weight~     reduction study is significant. To our knowledge, there had not been a successful~     translation of a highly efficacious obesity treatment in the military until The University~     of Tennessee Health Science Center implemented a pilot version of the Fit Blue program for~     active duty U.S. Air Force members in 2013. Following a successful pilot and extant results~     from the Look Ahead trial, Investigators expect success during the full scale Fit Blue~     study.~   "
75952|NCT02063165|"~     The purpose of this study is to understand the role of a dietary oil to alter chronic~     disease risk factors in women who are at risk for heart disease and/or diabetes. The~     investigator's previous study showed that safflower oil reduced trunk fat mass in women with~     diabetes. The investigators believe safflower oil can also attenuate criteria of metabolic~     syndrome through reduction in trunk fat mass.~   "
75953|NCT02063152|"~     This study aimed to evaluate the subsequent cancer risks, including gynecological cancers~     and malignancies at other sites, after the detection of screening positives and the~     diagnosis for primary cervical cancer.~   "
75954|NCT02063139|"~     Aim of the study is to investigate the short-term growth in children with asthma aged 5-11~     years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20~     micrograms per day~   "
75955|NCT02063126|"~     The main objective is evaluate to safety and efficacy of oral Reconnect ® (food~     supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR~     during an exercise test in CFS~   "
75956|NCT02063113|"~     The aim of this study is to determine whether the presence of vulnerability detected by~     geriatricians is associated with treatment discontinuation in older patient. During the~     comprehensive geriatric assessment realized before the decision-treatment, the following~     data are recorded and their impact in the therapeutic changes will also be analysed:~     comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.~   "
75957|NCT02063100|"~     -Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of~     patients with primary glomerulonephritis compare with Losartan potassium.~   "
75958|NCT02063087|"~     The investigators will test the impact of a decision aid, Head CT Choice, to determine if~     its use improves parents' knowledge and engagement in decision making and safely decreases~     healthcare utilization in children presenting to the emergency department with blunt head~     trauma.~   "
75959|NCT02063074|"~     The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle~     factors on bone health in young women over a 20-year time period. It is our primary~     hypothesis that premenopausal women with irregular periods or endocrine issues related to~     estrogen will have significantly poorer low back and hip bone health when compared to~     regularly menstruating women. It is our secondary hypothesis that long-term assessment of~     changes in endocrine function and lifestyle behaviors will assist in establishing risk~     factors for osteoporosis in young women. This study will include 1000 premenopausal women.~     The women will participate in the collection of a blood sample, bone scan, body fat~     measures, and lifestyle questionnaires. In addition, we hope to use this initial study to~     develop a group of women to follow throughout menopause, with additional visits occurring~     every 5 years over the course of their life.~   "
75960|NCT02063061|"~     The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT)~     is an effective treatment for erectile dysfunction.~   "
75961|NCT02063048|"~     The purpose of this study is to compare the effectiveness of text message-based support to~     usual care at promoting weight loss in patients with pre-diabetes.~   "
75962|NCT02063035|"~     Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine~     surgery will decrease the overall blood loss post-operatively. This reduction in blood loss~     will reduce the need for transfusion. In addition it will also significantly reduce the cost~     of the surgical procedure.~      Specific Aim 1: The goal of this study is to quantitatively assess whether topical~     application of tranexamic acid placed into the surgical wound during lumbar spine surgery~     will decrease post-operative blood loss, thus lowering the need for blood transfusions. By~     reducing the number of transfusions patients can avoid the well known complications~     associated with them. The investigators do not plan on measuring serum tranexamic acid~     levels.~      Several meta-analyses and level I studies have shown that IV administration of tranexamic~     acid is effective in reducing post operative blood loss and the need for transfusion~   "
75963|NCT02063022|"~     Controlled, randomized phase III study, with the intent of optimizing the treatment of not~     metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs~     intensive treatment. Both arms will receive an induction treatment followed by surgery~     (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on~     the basis of the response to the induction treatment (good or poor)~   "
75964|NCT02063009|"~     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the~     surgery and the patient. We currently use a local hemodynamic protocol based on the data of~     the literature. According to this protocol, specific patients may require cardiac index and~     central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with~     the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich,~     Germany). The technique is based on the injection of a cooled bolus of saline into a central~     vein with a central venous catheter (CVC). The variation of temperature is measured with an~     arterial femoral catheter and allows the assessment of the cardiac output according to~     Stewart-Hamilton's theory. Many studies showed the reliability of this technique.~      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral~     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the~     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be~     more difficult because of the port. It may be interesting to use the port for TPTD in order~     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by~     the port was as reliable as the classical measurement with a CVC.~   "
75965|NCT02062996|"~     Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic~     agent in over-the-counter decongestant sprays. It is used extensively at Nationwide~     Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding.~     Although there is generally limited vascular absorption, when administered in larger doses,~     uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH~     anesthesia department recently reported a case of oxymetazoline induced postoperative~     hypertension in a three-year-old child following inferior turbinate reduction and~     adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline~     and insert a varying number of pledgets during surgical procedures or instill oxymetazoline~     drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding~     the method of administration and the absorption of oxymetazoline or the dose-response~     relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies~     would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric~     population.~   "
75966|NCT02062983|"~     Early identification of patients at risk for cardiotoxicity represent a primary goal for~     cardiologist and oncologist~      From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function~     though its operator dependent. The use of other technique such as endomyocardial biopsy, is~     troublesome in clinical practice~      Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left~     ventricular ejection fraction (LVEF). This technique provides morphological, functional,~     perfusion, and viability information in one assessment. It is expensive and time consuming~     but id the diagnostic method of choice for patients with technically limited images from ECG~     and in patients with discordant information that is clinically significant from prior tests~   "
75967|NCT02062970|"~     Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV.~     Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response~     of the organism to a severe infection, associated with a circulatory failure marker by an~     arterial hypotension and a vascular hyperactivity to vasoconstrictor agents.~      The mechanisms involved on one hand an activation of white blood cells inflammatory system~     and the vascular inflammatory system; and on the other hand on imbalance in hemostatis~     characterized by an activation of the coagulation and an inappropriate fibrinolysis leading~     to a disruption of microcirculation in the context of a disseminated intravascular~     coagulation (DIVC).~      This inflammatory and thrombotic cellular activation is strongly associated with the~     phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by~     blood cells and vascular cells.~      MP are membranous vesicles, resulting in the reassortment of membrane phospholides in~     response to an activation of cellular apoptosis. They have been initially described as new~     actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF)~     confer them a procoagulating activity, which increases in patients undergoing septic shock.~      The finding of a fibriniolytic activity of the cellular MP suggests the existence of~     compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the~     control of the coagulolytic balance.~      Our recent researches suggest that endothelial and white blood cells MP produce in vivo~     plasmin.~      They carry into the main circulation a fibrinolytic activity which is partially beyond the~     physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that~     this ability of plasmin generation is important in patients affected with septic shock.~      Our hypothesis is that an increase in plasmin generation by MP compensates the risk of~     occurrence of microthrombosis, modulating therefore the vital prognosis of patients with~     septic shock.~      The coagulolytic balance of MP, which is resulting of their own procoagulating and~     fibrinolytic activities could claim the status of new pronostic marker relevant in patients~     with septic shock.~   "
75968|NCT02062957|"~     1. recruit 50 patients with atrial fibrillation and 30 controls~        2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)~        3. follow up the occurence of AF~   "
75969|NCT02062944|"~     The significance of this clinical trial lies in its potential to increase the success of~     immunosuppression (IS) therapy withdrawal in liver transplant (LT) recipients, thus~     decreasing the negative impact of IS on their long-term outcomes. Lifetime immunosuppression~     (IS) with standard agents, the calcineurin inhibitors (CNI) cyclosporine and tacrolimus~     (TAC), is currently required at clinically recommended doses and trough levels to prevent~     allograft rejection. However, this occurs at the significant expense of long-term CNI~     toxicity, i.e. chronic kidney disease (CKD), hypertension, hyperlipidemia, diabetes,~     infections and malignancy. With improvements in early graft and patient survival, long term~     adverse IS effects have become increasingly important in this rapidly expanding patient~     population. The strategies to reduce long term CNI toxicity include dose minimization that~     still leaves patients on CNI therapy, conversion to non-CNI therapy, or even complete IS~     withdrawal. The second approach, conversion to non-CNI IS therapy, is attractive in the~     potential to stabilize or improve renal function and other CNI toxicities. One such~     non-nephrotoxic IS agent, the mammalian target of rapamycin inhibitor (mTOR-I) SRL, has a~     different mechanism of IS action and studies have shown that CNI to SRL conversion can~     stabilize renal dysfunction with a low risk of rejection. Yet even with these possible~     benefits, patients on SRL are still subject to lifetime IS therapy with side effects and~     costs, highlighting the need to investigate the strategies that promote full IS withdrawal~     without rejection (3rd approach), also known as 'operational tolerance'.~   "
76046|NCT02061930|"~     The aim of this study is to review the long-term soft tissue stability and the long-term~     esthetic results of single crowns supported by tissue level implants placed in non-augmented~     healed sites.~      The hypothesis of the present study is that tissue level implants can achieve ideal esthetic~     outcomes in non-augmented healed sites.~   "
76047|NCT02061917|"~     To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess~     quality of life measures in smokers randomly switched from their usual brand of cigarette to~     one of three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco);~     or (3) an ultra-low machine yield tobacco-burning cigarette.~   "
75970|NCT02062931|"~     Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They~     are undifferentiated blank cells that do not yet have a specific function. Under proper~     conditions, they begin to develop into specialized tissue and organs. They are~     self-sustaining and can replicate themselves for long periods of time. They have the~     remarkable potential to develop into many different cell types in the body. They serves as a~     sort of repair system for the body, they can theoretically divide without limit to replenish~     other cells as long as the person is still alive. Premature ovarian failure (POF) is the~     loss of ovarian function in women less than 40 years. It is associated with sex steroid~     deficiency, amenorrhea, infertility and elevated serum gonadotropins. POF occurs in 1 % of~     women. In majority of cases the underlying cause is not identified. Management essentially~     involves hormone replacement and infertility treatment. This work aimed to evaluate the~     therapeutic potential of Autologous MSC transplantation in women suffering from Premature~     Ovarian Failure.~   "
75971|NCT02062918|"~     Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic~     mechanical-postural low back pain.~      Methods: A randomized controlled trial was carried out, involving 60 consecutively selected~     patients with chronic low back pain randomly allocated to an intervention group (use of~     abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at~     the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the~     inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris),~     patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested.~     Intention-to-treat analysis was also used.~      Hypothesis - abdominal belt will improve pain in chronic low back pain patients~   "
75972|NCT02062905|"~     The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained~     release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of chronic allergic conjunctivitis.~   "
75973|NCT02062892|"~     The investigators hypothesize that switching kidney transplant patients on~     tacrolimus/sirolimus long-term maintenance immunosuppressive drug regimens to~     tacrolimus/everolimus, will not only be safe, but will lead to better kidney function than~     patients staying on tacrolimus/sirolimus due to the lower potential of everolimus to enhance~     calcineurin inhibitors toxicity and/or its ability to even reverse some of the negative~     effects of calcineurin inhibitors on vascular endothelial and kidney function. To test this~     hypothesis vascular endothelial biomarkers will be analyzed in blood plasma samples and~     kidney dysfunction biomarkers in urine samples via liquid chromatography tandem mass~     spectrometry to evaluate whether switching kidney transplant patients on~     tacrolimus/sirolimus to tacrolimus/everolimus will lead to better kidney and endothelial~     function after one year and two years.~   "
75974|NCT02062879|"~     This study will compare ketamine and hydromorphone as alternative patient-controlled~     interventions for trauma-related pain. Patients receiving ketamine PCA are expected to~     require less total and breakthrough opioid and to have similar or improved objective pain~     scores. Patients receiving ketamine are also expected to have shorter duration of~     supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary~     toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is~     further expected to be associated with decreased intensive care unit and hospital lengths of~     stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and~     lower report of chronic pain syndromes.~   "
75975|NCT02062866|"~     To compare healing time, scar size, aesthetic outcome, and complication rates following~     second intention healing or purse string closure of surgical wounds on the trunk or~     extremities. This study, will allow surgeons to make informed decisions on whether purse~     string closure is superior to that of second intention healing and thus worth considering or~     inferior and not worth performing.~   "
75976|NCT02062853|"~     The primary aim of this study is to evaluate the effects of prospective patient education on~     patient satisfaction with administration of topical 5% 5-fluorouracil cream for the~     treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and~     forearms. Specifically, this study aims to determine if prospective patient viewing of an~     educational video delineating treatment effects and expectations improves patient~     satisfaction and treatment completion rates.~   "
75977|NCT02062840|"~     The investigators have observed in an open trial that a single session of whole body~     hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week~     in patients with major depression (MDD) severe enough to warrant inpatient hospitalization.~     In addition to reducing depression, the single session of WBH induced a prolonged reduction~     in mean core body temperature, consistent with basic science data from our group suggesting~     that hyperthermia activates a skin-to-brain pathway that have been shown in animals to be~     important for mood and body temperature regulation. Consistent with this known anatomy in~     our preliminary study in depressed patients, reductions in core body temperature were highly~     correlated with reductions in depressive symptoms over the same time period (one week post~     WBH). Moreover, patients with higher mean core body temperature prior to treatment had~     enhanced antidepressant effects. Because increased body temperature is an outcome of poor~     functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may~     actually sensitize this pathway in ways that promote changes in brain functioning known to~     promote emotional well-being. The results of our first open trial have encouraged us to~     conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which~     is currently underway at the University of Arizona Medical School. Missing from our~     assessments in this ongoing double-blind study is any measure of the impact of WBH on brain~     function. The current proposal addresses ths gap in our investigative portfolio by proposing~     to conduct a second, randomized trial of active vs. sham WBH that will examine the impact of~     WBH on measures of brain function known from prior studies to be important for both~     depression and its treatment.~   "
75978|NCT02062827|"~     To determine the safety and tolerability of the maximum dose for laboratory engineered~     Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of~     recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory~     engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of~     recurrent glioma~   "
77372|NCT02044627|"~     This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002~     and the routes and rates of excretion of [14C]-ETC-1002~   "
75979|NCT02062801|"~     The combined spinal epidural (CSE) technique has become increasingly popular for labor pain~     because of its rapid onset and superior first stage analgesia. However, increased risk for~     early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various~     factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine~     administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody~     has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of~     CSE administration during labor. The purpose of this study is to measure the incidence of~     EPFB after combined spinal epidural analgesia using standard definitions. The incidence of~     EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the~     time of CSE placement.~   "
75980|NCT02062788|"~     Elective colectomy procedures typically require bowel preparation starting 2 days prior to~     the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by~     mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though~     it may ensure a cleaner and safer surgery, this longer period of starvation increases~     insulin resistance and may increase post-op complications. However, there is evidence that~     administration of oral rehydration solution(ORS) prior to surgery reduces insulin~     resistance. Our purpose is to evaluate the difference of insulin resistance in those who~     received ORS 1 day prior to surgery and those who did not.~   "
75981|NCT02062775|"~     The purpose of this study is to determine if self-fixating polyester mesh will have lower~     incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when~     used for laparoscopic inguinal hernia repair.~   "
75982|NCT02062762|"~     The main objective of the current study is to evaluate whether a mindfulness based~     intervention delivered online can provide an effective resource for increasing psychological~     well-being among students. In addition, explore potential mechanisms through which the~     training lead to improvements by means of mediational analyses, with hypothesized variables~     like positive/negative affect and attention regulation.~   "
75983|NCT02062749|"~     The goal of this clinical research study is to find the highest tolerated dose of heated~     intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers~     also want to learn more about the ways that pediatric and young adult colon cancer may be~     different from colon cancer in adults.~   "
75984|NCT02062736|"~     The purpose of the study ( observational and prospective ) is to evaluate the efficacy and~     tolerability of the methadone maintenance treatment in patients addicted to heroin. The~     efficacy and tolerability are assessed by correlating to the adequacy of the dosage of~     methadone. The patients will be observed for two years.~   "
75985|NCT02062723|"~     The efficacy and tolerability of Eptadone® in the context of a maintenance program will be~     evaluated in an observational prospective, multicenter study, in heroin addicted patients.~   "
75986|NCT02062710|"~     The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two~     liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa~     flavoring, and, dextromethorphan syrup, compared with placebo.~   "
75987|NCT02062697|"~     Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic~     malignancies in western civilized countries, with an estimated prevalence in Europe and the~     US of 752,600 in 2007 and 59,828 deaths annually.~      State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum~     cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is~     low, and both tests are not effective enough at detecting EOC early enough to improve~     clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological~     confirmation. These findings underline the importance for an effective test for early~     detection of EOC.~      In the current project we will obtain a lavage of the uterine cavity. It will be~     investigated whether cells from EOCs or genetic material from those cells can be detected in~     the lavage fluid.~      Aim of this study:~      There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.~   "
75988|NCT02062684|"~     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod~     administration in addition to standard therapy in patients with biopsy proven IgA~     Nephropathy with persistent proteinuria of between 1-6 g/day.~   "
75989|NCT02062671|"~     In patients with polycystic kidney disease, pain may be resistant to drug therapy and may~     reduce quality of life. This study investigate the effect of renal denervation on this pain.~   "
75990|NCT02062658|"~     This study investigates if a single dose of IV Ketamine can rapidly improve~     Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with~     a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response~     Prevention (EX/RP). You will be compensated for your time and travel. Participants must be~     between the ages of 18-55.~   "
75991|NCT02062645|"~     The population that will be included in this study, will be regular Turkish hypertensive~     patients who are expected to consume sodium in high amounts. It is hypothesized that, in~     that population, amlodipine/valsartan will be effective at the same rate of blood pressure~     (BP) control rate as expected from literature.~   "
75992|NCT02062632|"~     This pilot randomized clinical trial studies the effects of taking doxepin hydrochloride as~     compared to placebo (inactive drug) in treating esophageal pain in patients with cancer~     located in the chest area receiving radiation therapy to the thorax with or without~     chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently~     shown to be helpful for mouth pain in patients receiving radiation therapy. Doxepin~     hydrochloride affects the surface of the esophagus, which may be helpful in reducing the~     pain caused by radiation therapy.~   "
76048|NCT02061904|"~     Prospective explorative study for the investigation of short-term and medium-term outcomes~     regarding bone mineral density changes after revision hip arthroplasty making use of bone~     impaction grafting. Outcome measurements will include objective and subjective clinical~     data, complications and adverse events, radiographic data measurements recorded at several~     postoperative intervals.~   "
76106|NCT02061137|"~     The Trial Objective is to assess safety and efficacy of oral fingolimod (FTY720) in children~     older than 6 years with Rett Syndrome. So far there is no established treatment for children~     with Rett Syndrome. Therefore a positive result in terms of safety and first indications of~     efficacy would path the way to a phase II clinical study with more patients to further test~     the hypothesis that fingolimod treatment may slow down the regression of motor and language~     skills.~   "
75993|NCT02062619|"~     Central alexia is a common reading disorder caused by stroke. Patients with central alexia~     (CA) are slow to read and make frequent errors, and have additional problems with their~     spoken language.~      This study has 3 aims:~        1. Investigating the neural networks that support reading in patients with CA Despite~          being a relatively common syndrome, there have been no functional brain imaging studies~          of CA. This project will use magnetic resonance imaging (MRI) and~          magnetoencephalography (MEG) to understand which brain regions are damaged and whether~          preserved parts of the reading network can be encouraged by therapy to support reading~          recovery.~        2. Testing a new treatment for CA The research team has developed training software called~          'iReadMore', which uses a crossmodal approach (written words paired with spoken words)~          to train reading. This therapy has been shown to be effective in patients with a~          similar form of reading disorder called pure alexia. The iReadMore software will be~          adapted to address the reading deficit in CA, and the research will test whether it~          significantly improves reading ability.~        3. Using brain stimulation to enhance behavioural training Transcranial direct current~          stimulation (tDCS) is a brain stimulation technique that has been shown to improve~          language performance in healthy controls and stroke patients. This study will test~          whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly~          enhances reading rehabilitation. Patients will be split into two groups: one will~          receive a 4 week block of training plus real tDCS first, followed by a 4 week block of~          training plus sham tDCS; the other group will receive the two therapy blocks in the~          opposite order. Both groups will ultimately receive the same amount of behavioural~          therapy and tDCS stimulation. Comparing the reading improvement over the real and sham~          tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in~          reading ability.~      Hypothesis:~      iReadMore reading therapy will significantly improve single word reading speed in patients~     with central alexia.~      tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared~     to sham stimulation.~   "
75994|NCT02062606|"~     To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve~     correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity~     System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod~     systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).~   "
75995|NCT02062593|"~     In this study the investigators will use careful scientific blinding of patient and their~     subsequent healthcare staff so that the investigators can determine exactly how much~     difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6~     weeks blinded phase, all patients will be unblinded and the patients who had undergone sham~     procedure will be offered the active therapy.~   "
75996|NCT02062580|"~     In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected~     children develop AIDS and die faster in SSA than those in developed countries. Bacille~     Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from~     severe forms of TB. BCG is known to cause immune cells to be active and replicate faster.~     The immune system of neonates also responds differently to BCG that to other vaccines and~     infections. We hypothesize that the routine immunization of neonates with BCG contributes to~     generalized immune activation in HIV-exposed infants resulting in skewed immune responses to~     vaccines and infections and increased rates of disease progression in those infants that~     become HIV-infected. However, delaying BCG until HIV testing is completed would result in~     operational difficulties, and may not induce the appropriate immune response. Delayed BCG~     would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We~     plan to assess immune cells in infants to determine the impact of the timing of BCG~     vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also~     compare the immune activation and disease progression of those infants that become~     HIV-infected in the BCG or control arms. Our results will provide key insights into the~     effect of BCG vaccination on immune responses to HIV as well as inform the optimal timing of~     BCG vaccination for HIV-exposed infants.~   "
75997|NCT02062567|"~     With this project the investigators wish to:~        1. Test the reproducibility of Amlang's ultrasound classification by examining the intra-~          and inter-rater reliability.~        2. Investigate whether Amlang's ultrasound classification is able to predict which~          patients are likely to develop complications when treated non-operatively.~        3. Investigate whether Barfod's length measurement is able to predict which patients are~          likely to develop complications when treated non-operatively.~   "
75998|NCT02062554|"~     BHS is a cohort study of consecutive myocardial infarction (MI) patients admitted within the~     first 24 hours of symptoms and has been ongoing since May of 2006. The purpose of this study~     is to assess for possible markers for increased risk after MI.~   "
75999|NCT02062541|"~     Background: Illness and hospitalisation, even of short duration, pose separate risks for~     permanently reduced functional performance in elderly medical patients. Functional~     assessment in the acute pathway will ensure early detection of declining performance and~     form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For~     optimal results rehabilitation should begin immediately after discharge.~      The aim of this study is to investigate the effect of a systematic functional assessment in~     the emergency departments (ED) of elderly medical patients with reduced functional~     performance when combined with immediate post-discharge rehabilitation.~      Method/design: The study is a two-way factorial randomised clinical trial. Participants will~     be recruited among patients admitted to the ED who are above 65 years of age with reduced~     functional performance. Patients will be randomly assigned to one of four groups: 1)~     functional assessment and immediate rehabilitation; 2) functional assessment and usual~     rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and~     usual rehabilitation.~      Primary outcome: 30-second chair-stand test administered at admission and two weeks after~     discharge.~      We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in~     sustained or improved performance in comparison to regimen in which neither of these~     interventions are offered.~   "
76000|NCT02062528|"~     The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes~     frequency.~   "
76001|NCT02062515|"~     The purpose of this study is to determine whether Icotinib is efficient and safe in treating~     advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.~   "
76002|NCT02062502|"~     This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella~     Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™~     2007 process. The primary hypotheses being tested are that antibody response rate and mean~     antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are~     non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate~     induced by VARIVAX™ NSP is acceptable.~   "
76140|NCT02060695|"~     The purpose of this study is to determine the temporal relationship between motor~     fluctuations and non-motor fluctuations in persons with Parkinson's disease.~      Observational study case-only~   "
80559|NCT02002962|"~     The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum~     toxin injection for preventing post-procedural atrial fibrillation in patients undergoing~     the radiofrequency ablation of atrial flutter.~   "
76003|NCT02062489|"~     The current study is a multicentre, randomized,double-blind, prospective clinical trial~     stratified patients by the HER2 status of their cancer (negative or positive) which is~     sponsored by the researchers. The trial is designed to evaluate the effectiveness of~     tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer~     patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast~     cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical~     mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen~     (20 mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy~     and/or radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the~     breast tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin)~     combined with tamoxifen or placebo. The follow-up time will be eight years. The aim of this~     trial is to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR~     negative, ER-β positive operable breast cancer patients by comparing the DFS and OS between~     tamoxifen group and placebo group and to determine whether the percentage of positive ER-β~     expression is associated with the response to the hormone therapy in breast cancer.~   "
76004|NCT02062476|"~     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic~     disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants~     with cow's milk allergy (CMA). The mechanisms of these effects are still largely undefined.~     The effect of LGG could be related at least in part by the immunoregulatory role played by~     LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or~     non-IgE-mediated CMA (i.e., IL-4, IL-5, IL-10, IFN-γ , TGF-beta, and TNF-alfa), which can~     contribute to modulation of inﬂammatory processes. We have demonstrated that children with~     IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's~     milk protein, and that tolerance is associated with a marked reduction of IL-13 production~     and a concomitant increased frequency of IFN-γ releasing cells.~      Epigenetics studies the heritable (and potentially reversible) changes of the genome~     inherited from one cell generation to the next which alter gene expression but do not~     involve changes in primary DNA sequences, highlighting the complexity of the~     inter-relationship between genetics and nutrition. There are three distinct, but closely~     interacting, epigenetic mechanisms (histone acetylation, DNA methylation, and non-coding~     microRNAs) that are responsible for modifying the expression of critical genes associated~     with physiologic and pathologic processes. The profile of epigenetic modifications~     associated with Th lineage commitment, coupled with the sensitivity of the early~     developmental period, has led to speculation that factors that disrupt these pathways may~     increase the risk of allergic diseases. Specifically, effects on DNA methylation and~     endogenous histone deacetylase inhibitors acting on specific pathways (Th1 and T regulatory~     cell differentiation) may favour Th2-associated allergic differentiation. MicroRNAs are~     another structural components of an epigenetic mechanism of post-transcriptional regulation~     of messenger RNA translation. It has been recently identified a specific Th2-associated~     miRNA (miR-21) that is critical for the regulation of Th cell polarization.~   "
76005|NCT02062463|"~     This study is conducted to assess whether training participants on proper use of BF SPIROMAX~     and Symbicort TURBOHALER will improve their device-handling technique and potentially~     improve their treatment outcome, ie, better asthma control.~   "
76006|NCT02062450|"~     The purpose of this study is to demonstrate the performance and reliability of Tornier Dual~     Mobility Cup used during primary total hip replacement or hip replacement revision surgery~     at least 24 months post-insertion.~   "
76007|NCT02062437|"~     The aim of this study is to assess safety and general performance of total hip arthroplasty,~     composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction~     pair Biolox® Delta Ceramic.~   "
76008|NCT02062424|"~     The objective of this study is to test the effect of substitution dietary guidelines that~     are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary~     intake in the general Danish population.~   "
76009|NCT02062411|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is~     effective in the treatment of attention deficit and emotional, executive function and social~     function dysregulation due to attention deficit disorder (ADHD).~   "
76010|NCT02062398|"~     The current study will evaluate the safety and performance of the BlueWind Medical Reprieve~     System for the treatment of Chronic Painful Peripheral Neuropathy.~   "
76011|NCT02062385|"~     This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of~     RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks~     and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be~     enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also~     receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus~     vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either~     staggered or concomitantly with V260 or placebo. All participants will be followed for~     efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of~     participants. The primary hypothesis of the study states that V260 will be efficacious in~     preventing any severity of rotavirus gastroenteritis as compared with placebo.~   "
76012|NCT02062372|"~     Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of~     different therapeutic modalities including resection, concurrent chemo- and radiotherapy and~     adjuvant temozolomide. However, survival is still poor and most of these tumours recur~     within one to two years within the previously irradiated target volume.~      The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted~     magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include~     microscopic speculated growth. These margins result in a high dose to surrounding healthy~     appearing brain tissue. Moreover, the short progression-free survival indicates a possible~     geographical miss. There is a clear need for novel imaging techniques in order to better~     determine the degree of tumour extent at the time of treatment and to minimize the dose to~     healthy brain tissue.~      The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T)~     provides an increased ability to detect, quantify and monitor tumour activity and determine~     post-treatment effects on the normal brain tissue as a result of a higher resolution,~     greater coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only~     few investigators have examined the use of UHF MRI in patients with malignant brain tumours.~     These studies show its potential to assess tumour microvasculature and post-radiation~     effects such as microhaemorrhages.~      This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV)~     in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies~     will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T~     MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively~     identified when compared to the 3T MRI.~   "
76141|NCT02060682|"~     This registry will collect real-world clinical evidence on the performance, safety, and~     usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved~     labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow~     Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS~     Catheter. All subjects will receive diagnostic treatment according to clinical indications~     and center standard practice.~   "
76013|NCT02062359|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for~     treating patients with melanoma that involves taking white blood cells from the patient,~     growing them in the laboratory in large numbers, genetically modifying them, and then giving~     the cells back to the patient. In a previous study, the NCI Surgery Branch used the~     anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor-fighting cells~     (anti-ESO-1 cells). About half of the patients who received this treatment experienced~     shrinking of their tumors. In this study, we are using a slightly different method of~     producing the anti-ESO-1 cells selected for a specific cell type, which we hope, will be~     better in making the tumors shrink.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the ESO-1 molecule on their surface can cause melanoma~     tumors to shrink and to see if this treatment is safe.~      Eligibility:~      -Adults 18 and older with cancer that has the ESO-1 molecule on tumor surfaces~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-ESO 1 cells and aldesleukin. They will stay~          in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
76014|NCT02062346|"~     Patients with vasculitis commonly develop high blood pressure (hypertension) and this is~     associated with an increased risk of heart disease. It is thus important to lower blood~     pressure in those with hypertension. However, hypertension in vasculitis is inadequately~     controlled with many currently available blood pressure lowering agents.~      Endothelin is a chemical produced by blood vessels that contributes to the development of~     hypertension. Higher than normal levels of endothelin are seen in patients with vasculitis.~     By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the~     investigators can hopefully treat hypertension in patients with vasculitis. The purpose of~     the study is to ascertain whether endothelin receptor antagonists lower blood pressure and~     improve blood vessel function more effectively in patients with vasculitis than those~     without it.~   "
76015|NCT02062333|"~     The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia~     on Stapes Reflex and Distortion Product Auto Acoustic Emission.~   "
76016|NCT02062320|"~     The aim of this study is to compare the efficacy of analgesic methods after Caesarean~     Section before and after Post Caesarean Acute Pain Service establishing.~   "
76017|NCT02062307|"~     The aim of this study is to investigate the markers of bone mineral metabolism in an~     unconfounded group of patients with hypogonadism and to search for a relationship between~     endothelial dysfunction and insulin resistance.~   "
76018|NCT02062294|"~     This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in~     preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from~     eligible patients will be collected for the 6 months following transplantation.~   "
76019|NCT02062281|"~     The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children~     and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs),~     meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006~     in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the~     children and adults. The main objective of this study is to show that both vaccines can~     safely be administered together without affecting the immune response of protecting against~     disease.~   "
76020|NCT02062268|"~     Conduct a KAP survey before and after intervention and describe the current knowledge,~     attitudes and behaviors on drink driving in public and analyse the influential factors to~     provide rational strategies to enhance the awareness on drink driving in public.~   "
76021|NCT02062255|"~     Obesity promotes worse outcome for post-menopausal breast cancer patients.~   "
76022|NCT02062242|"~     The purpose of this study is to evaluate the effectiveness of transvaginal electrical~     stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt~     and contraction of accessory muscles in the acquisition of ability to contract the pelvic~     floor muscles (PFM), as well as to evaluate the sexual function of women studied.~   "
76023|NCT02062229|"~     Infertility is a common problem, affecting perhaps one couple in six, the majority of whom~     now seek medical care. It is becoming a social challenge because it is responsible for~     personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of~     the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence~     or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by~     the conventional assessment of the semen profile - constructed according to recognized~     guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers~     are available.~      We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid~     biomarker useful for the diagnosis of male infertility.~   "
76024|NCT02062216|"~     The primary objective of this study is to assess whether inflammatory receptors play a role~     in the pathogenesis of atherosclerosis.~   "
76025|NCT02062203|"~     The main purpose of this study is to evaluate the effect of single oral therapeutic and~     supratherapeutic doses of AKB-6548 on the QT interval.~   "
76026|NCT02062190|"~     Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters~     in patients with schizophrenia taking antipsychotics?~   "
76027|NCT02062177|"~     Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for~     gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for~     providing optimal sedation regimen and avoiding under or oversedation. The objective of the~     study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus~     propofol NAPS.~   "
76049|NCT02061891|"~     The aim of this study is to evaluate if acute invasive coronary evaluation and treatment~     conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred,~     subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation~     myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an~     observational design the potential clinical benefit of coronary computed tomography~     angiography (CCTA) to select patients for invasive investigation and treatment in the two~     treatment arms (acute vs deferred) is evaluated.~      The following main hypothesis will be tested:~        -  Very early invasive coronary investigation improves clinical outcome in patients with~          UAP/NSTEMI-ACS~        -  CCTA performed before invasive coronary investigation will improve clinical management~          of patients with UAP/NSTEMI-ACS~   "
76028|NCT02062164|"~     The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery~     is the only effective treatment to achieve sustained weight loss in adults with extreme~     obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric~     surgery is equally effective; however, due to the paucity of long-term data, the long-term~     effects and risks are unknown. Thus, due to surgical risk and ethical implications,~     bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are~     increasing.~      The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery~     in the context of a structured preparation and follow-up program. The study is a subproject~     of the study Medical and psychosocial implications of adolescent extreme obesity -~     acceptance and effects of structured care (DRKS00004172). At 5 German university centers~     (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are~     participants in the overall project will be enrolled in a structured preparation and~     follow-up program. The program is designed to improve adherence and compliance and will~     result in comprehensive follow-up data. In addition to the data gathered in the overall~     project, subjects participating in subproject 3 will undergo assessments pertinent to~     bariatric surgery, as proposed in the American Teen-LABS study~     (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison~     will be made with BMI matched adolescents who participate in the overall project but do not~     undergo bariatric surgery.~      In November 2014 recruitment for the overall project was completed. However, patients~     interested in bariatric surgery will still be recruited until September 2016. There~     assessment will be the same as for patients recruited earlier. However, in an amendment in~     December 2014, the frequency of assessment via questionnaire was reduced from biannually to~     annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.~   "
76029|NCT02062151|"~     This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants~     who require pharmacologic therapy at Tampa General Hospital (TGH). We intend to evaluate~     acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and~     methodological issues. We plan to also test and generate hypotheses in preparation to apply~     for funding a larger randomized controlled trial.~   "
76030|NCT02062138|"~     The purpose of the study is to determine the effectiveness of new interventional approaches~     in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that~     active training programs are more effective in improving physical function than the passive~     standard-of-care therapy.~   "
76031|NCT02062125|"~     This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how~     common and if there are any risk factors for having calcinosis~      2) to identify common complications associated with scleroderma-related calcinosis.~   "
76032|NCT02062112|"~     The purpose of this study is to determine whether the pattern of flavoring and drinking of~     laxatives for colonoscopy can improve the experience of patients when they are undergoing~     bowel preparation for the test.~      Investigators hypothesize that patients will have a better experience if patients taste the~     bowel preparation laxative with and without flavoring and then decide how they want to drink~     the rest of the laxative since taste preferences vary widely from person to person.~   "
76033|NCT02062099|"~     Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is~     characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile~     plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both~     of which are associated with the loss of neurons. The development of disease biomarkers for~     AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET~     imaging and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes~     underlying cognitive impairment biomarkers, have been incorporated into revised diagnosis~     guidelines.~      Post-mortem human AD and AD animal model studies have reported inflammatory processes also~     implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory~     cytokines.~      In vivo visualization of microglial activation has become possible with the development of~     molecular imaging ligands (tracers) for use with positron emission tomography (PET). The~     translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR),~     a receptor located in the outer membrane of mitochondria, is upregulated during~     neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an~     attractive biomarker for neuroinflammation.~      The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and~     distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with~     amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive~     decline.~   "
76034|NCT02062086|"~     Current methods for the quantification of muscle mass are indirect, lack precision, and~     often rely on expensive equipment that only provides limited (indirect) data on whole body~     muscle mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of~     lean mass, easy to use in clinical practice and research. However, it assesses an indirect~     measurement of total-body skeletal muscle mass and its clinical use for determination of~     changes in muscle mass may be very limited due to instrumentation availability, particularly~     in field studies, and cost. Moreover, these methods provide estimates of fat free mass that~     is not skeletal muscle specific, and are influenced by changes in regional or total body~     water content.~      GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine~     dilution for the estimation of muscle mass and has begun clinical evaluation of this~     muscle-measure in healthy young and older adults.~   "
76035|NCT02062073|"~     Purpose of this study will be to determine the potential of abametapir lotion to induce~     sensitization by repeated topical application to the healthy skin of humans under controlled~     conditions.~   "
76036|NCT02062060|"~     Purpose of this study is to evaluate the efficacy of at-home administration of a single~     application of abametapir lotion 0.74% w/w for the treatment of head lice.~   "
76050|NCT02061878|"~     The primary objective of this proof of mechanism pilot clinical trial is to determine if the~     RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the~     clearance of Amyloid-Beta~   "
76051|NCT02061865|"~     The primary objective of the study is to investigate the safety of intravitreal (IVT)~     REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).~   "
76052|NCT02061852|"~     The purpose of this study is to determine whether the medical device simeox is safe in the~     treatment of respiratory diseases, in comparison with traditional physiotherapy.~   "
76053|NCT02061839|"~     Main objective is to show that a photoprotective sunscreen having a protection against the~     visible light is more effective than a sunscreen having the same UVA AND UVB protection but~     with a low (weak) protection against the visible, to prevent the relapses of the melasma~     during the summertime.~   "
76054|NCT02061826|"~     The purpose of the study is to establish drug-induced liver injury databases in China, make~     criteria for Chinese drug-induced liver injury patients and evaluate the application of~     certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.~   "
76037|NCT02062047|"~     The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root~     (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine~     (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic~     subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is~     that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic~     and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty~     diabetic subjects with chronic periodontitis will be divided in the following therapeutic~     groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours,~     application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution~     during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and~     irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP~     group: SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will~     be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding,~     probing depth, clinical attachment level, bleeding on probing and suppuration. At these same~     periods, glycated hemoglobin levels will be obtained from all subjects. In addition, six~     subgingival biofilm samples per subject will be analyzed by checkerboard DNA-DNA~     hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. Finally,~     gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for~     the levels of cyto/chemokines by ELISA. Data will be submitted to appropriate statistical~     analysis.~   "
76038|NCT02062034|"~     The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant~     therapy on progression, clinical regression, oxidative stress markers and mitochondrial~     dysfunction in non-proliferative diabetic retinopathy.~   "
76039|NCT02062021|"~     Autoimmune diseases are diseases in which inappropriate immune responses that have the~     capability of harming host cells play an important role. Evidence suggests that the presence~     of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus~     erythematosus increase the risk of cardiovascular disease (CVD). However, this evidence is~     inconsistent for autoimmune disorders and no systematic approach has been previously used to~     study the relationship between a range of common autoimmune disorders and specific forms of~     cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid~     haemorrhage, or venous thrombosis.~      The investigators will use linked electronic health records to investigate whether commonly~     diagnosed autoimmune disorders are associated with increased risk of CVD development and~     whether effects differ in men and women and change with age.~   "
76040|NCT02062008|"~     The purpose of this study is to understand how simultaneous PET/MR acquisition can provide~     novel qualitative and quantitative biomarkers to guide clinical intervention and predict~     prognosis of patients with cardiovascular disease.~   "
76041|NCT02061995|"~     Osteoporosis is a systemic skeletal disease characterized by low bone mass and~     microarchitectural deterioration of bone tissue, with a subsequent increase in bone~     fragility and susceptibility to fracture.~      Osteoporosis is one of the most common and debilitating chronic diseases, and a global~     health concern with a high prevalence not only in Western countries, but also in Asia and~     Latin America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption~     like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic~     agent. Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in~     bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of~     treatment (Black et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the~     availability of pharmacological treatments, osteoporosis remains a significant health~     problem for patients who do not respond to the available treatments or fail to comply with~     their regimens.~      The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a~     proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic~     patients who do not respond to pharmacological treatments.~   "
76042|NCT02061982|"~     Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee~     will be tested in subjects with computer tests on attention and alertness. Comparison of the~     results with published results from controlled experiments will indicate the effectiveness~     of home experiments.~   "
76043|NCT02061969|"~     This is a study to determine whether glycemic control, as measured by change in HbA1c and~     frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and~     basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with~     poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with~     linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that~     treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement~     in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC~     residents with T2D. We will also determine differences in clinical outcome, resource~     utilization, and hospitalization costs between LTC residents with T2D treated with~     linagliptin and basal and correction insulin. We will compare differences in complications~     (infectious and non-infectious, neurological and cardiovascular events), emergency room~     visits and hospitalizations between groups during the 6 months of intervention.~   "
76044|NCT02061956|"~     Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most~     frequent cause of death of cancer.Although with the development of medical science, more and~     more patients diagnose HCC at early stage, a lot of patients with HCC still continue to~     present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these~     patients could received transcatheter arterial chemoembolization (TACE) or new agents as~     initial treatment. However, the intermediate group comprises a wide spectrum in terms of~     liver function and extent of tumour, and this may explain the large differences in survival~     reported for individual series.~      A simple, pragmatic and reliable prognostic index based on objective measures would be of~     value in providing information to patients, for stratifying patients entering clinical~     trials and in making meaningful comparisons between series reported in the literature.The~     aims of our study were (i) to identify predictors of survival in a cohort of patients~     undergoing TACE or TAE for unresectable HCC, (ii) to develop and validate a simple scoring~     system and (iii) to compare the new scoring system with the most frequently used prognostic~     systems for its ability to separate high- and low-risk patients.~   "
76055|NCT02061813|"~     The purpose of the study is to determine the irritation potential of repeat applications of~     abametapir lotion on normal skin.~   "
76056|NCT02061800|"~     This study is a research study involving subjects who are diagnosed with a malignant~     disease, that has either failed standard therapy or is unlikely to be cured with standard~     non-transplant therapy, who will receive a peripheral blood stem cell transplant. A~     malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase,~     accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic~     Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL);~     or Lymphoma (Hodgkin's and Non-Hodgkin's) The purpose of this study is to learn more about~     the effects of CD34+ stem cell selection on graft versus host disease (GVHD) in children,~     adolescents and young adults. CD34+ stem cells are the cells that make all the types of~     blood cells in the body. GVHD is a condition that results from a reaction of transplanted~     donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs.~     Study subjects will be offered treatment involving the use of a Miltenyi CliniMacs CD34+~     selection device to remove T-cells from a peripheral blood stem cell transplant in order to~     decrease the risk of acute and chronic GVHD.~   "
76057|NCT02061787|"~     The application of cardiopulmonary exercise testing in assessment outcomes of patients with~     pulmonary hypertension.~   "
76058|NCT02061774|"~     The purpose of this project is to study the effects of preoperative followed by scheduled~     intravenous acetaminophen on pain control for 24 hours postoperatively after minimally~     invasive 1 or 2 level transforaminal lumbar interbody fusion.~   "
76059|NCT02061761|"~     The purpose of this study is to characterize the safety, tolerability and maximum tolerated~     dose of BMS-986016 administered alone or in combination with Nivolumab to subjects with~     relapsed hematologic malignancies.~   "
76060|NCT02061748|"~     This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct~     comparative safety and effectiveness studies of dabigatran and warfarin using real world~     data from Humana's health plan operations.~   "
76061|NCT02061735|"~     A combined set of quantitative skin imaging methods will quantitatively describe the natural~     ontogeny and the response to standard treatments over time in patients with infantile~     hemangiomas.~   "
76062|NCT02061722|"~     The aim of this study is to measure the availability of the PDE10A enzyme in Huntington~     disease gene expansion carriers (HDGECs) using the recently developed radioligand~     [18F]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the~     disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The~     HDGECs included in this study will be recruited from the large database of the REGISTRY~     (NCT01590589) or ENROLL-HD (NCT01574053) studies.~   "
76063|NCT02061709|"~     The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at~     reducing allergy symptoms in people who suffer from allergy to Ragweed pollen~   "
76064|NCT02061696|"~     The goal of the research study is to observe the clinical safety, effectiveness and patient~     satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and~     possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared~     to standard manual compression.~   "
76065|NCT02061683|"~     This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure~     (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.~   "
76066|NCT02061670|"~     The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to~     subjects suffering from both ragweed allergy and asthma.~   "
76067|NCT02061657|"~     The aim of this research work is to assess the effect of using single preoperative dose of~     rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the~     operation and possible operative complications~   "
76068|NCT02061644|"~     We aim to investigate the effect of spinal anesthesia on intraocular pressure.~   "
76069|NCT02061631|"~     Primary Objective:~      To evaluate the overall response rate (including complete response and partial response) of~     subjects treated with combination therapy docetaxel and cisplatin followed by the~     chemoradiotherapy in patients with locally advanced head and neck cancer~      Secondary Objective:~      To assess the safety and tolerability of combination therapy docetaxel and cisplatin~     followed by the chemoradiotherapy in patients with locally advanced head and neck cancer~   "
76070|NCT02061618|"~     The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a~     culturally-sensitive dance intervention is an accepted and effective physical intervention~     for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if~     Bollywood dance exercise improves diabetes outcomes in South Asian women.~   "
76071|NCT02061592|"~     To evaluate the clinical performance of daily disposable etafilcon A lenses.~   "
76072|NCT02061579|"~     The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the~     optimal and feasible level of frequency of structured contact needed in a clinical setting~     for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity~     recommendations long-term.~   "
76073|NCT02061566|"~     Indoxyl sulfate (IS) is an anionic uremic toxin that is accumulated in the serum of patients~     with uremia. In previous study, the investigators successfully induced AKI animal model. IS~     enhanced intercellular adhesion molecule-1 (ICAM-1) expression in IL-1β-treated human~     umbilical vein endothelial cells (HUVECs) that this may play a critical role in the~     progression of AKI. However, the molecular mechanisms of ICAM-1 expression in IS-treated~     IL-1β-treated HUVECs need to be elucidated. HUVECs incubated with 0.2 or 1 mM IS for 24 h~     did not cause cytotoxicity. The IL-1β-induced ICAM-1 expression in HUVECs was significantly~     enhanced by IS pretreatment. Furthermore, the regulation of adhesion molecule expression~     involves a complex array of intracellular signaling pathways including mitogen-activated~     protein kinase (MAPKs), reactive oxygen species (ROS) and transcriptional factors. A better~     understanding of this might provide important insights into the prevention of AKI.~   "
76104|NCT02061163|"~     To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can~     accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's~     disease.~   "
76160|NCT02060435|"~     The investigators analyzed clinical outcome in DLBCL patients according to age group to~     define the impact of EBV status on the clinical outcome.~   "
80590|NCT02002559|"~     This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for~     diagnosis of early esophageal cancers among high risk patients.~   "
76074|NCT02061553|"~     This investigation addresses emotional health in community dwelling persons with traumatic~     brain injury (TBI). It is designed to test the efficacy of a novel behavioral treatment for~     depression and anxiety symptoms. This treatment incorporates principles of Behavioral~     Activation (BA), a promising treatment model for depression and anxiety after TBI, and~     implementation intentions, a theoretically motivated method to enhance enactment of~     goal-relevant behaviors via action planning. To maximize the impact of this intervention~     over time, we use the low-cost, widely available technology of SMS, or text messaging, to~     promote positive behavior change in accordance with planned goals and intentions.~     Participants are randomized 2:1 to a condition using BA-based implementation intentions or~     to a control condition in which participants receive SMS messages with self-selected~     motivational statements.~   "
76075|NCT02061540|"~     The study is an open-label study in adults with primary sclerosing cholangitis to evaluate~     the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.~   "
76076|NCT02061527|"~     To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the~     setting of breast cancer treatment.~   "
76077|NCT02061514|"~     -  Major surgery can lead to postoperative disturbances in sleep patterns with subjective~          deterioration of sleep quality according to patients' reports as well as objective~          alterations of sleep architecture, as recorded by polysomnography~        -  Factors implicated in postoperative sleep disturbances include but are not limited to~          the severity of the surgical procedure, the neuroendocrine response to surgery,~          inadequate treatment of postoperative pain and external factors interfering with sleep,~          such as light, noise and therapeutic procedures~        -  There are differences in the molecular mechanisms inhalational anesthetics and~          intravenous agents affect different brain regions to induce anesthesia. Our hypothesis~          is that these differences may also be evident during the postoperative period,~          affecting brain functions which are involved in postoperative sleep architecture. So,~          the aim of this study will be to assess the effect of two different anesthetic~          techniques (propofol versus desflurane) of maintaining general anesthesia in patients~          subjected to similar major operations~        -  Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI),~          regarding preoperative and long term postoperative sleep quality, sleep diaries~          regarding early postoperative sleep quality and biochemical markers (cortisol,~          prolactin and melatonin) regarding neuroendocrine response to surgery and disturbances~          in endogenous circadian secretion associated with sleep~   "
76078|NCT02061501|"~     Visual cognitive deficits in children are frequent, with an impact on working and daily~     activities. Optometric therapy may improve those functions, however few studies have been~     performed.~      We aim to evaluate the efficacy of such therapy by a comparative study between two groups of~     children aged between 5 and 12 after 6 months of rehabilitation.~   "
76079|NCT02061488|"~     The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle~     Point Model Predictive Control : SP-MPC)~   "
76080|NCT02061475|"~     Venipuncture and intravenous cannulation are the most common painful procedures, especially~     for the penitents who must receive large diameter venous catheter before surgery. In present~     study we would evaluate the safety and validity of lidocaine patches releasing such pain.~   "
76081|NCT02061462|"~     The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted~     strategy to increase organ supply.~   "
76082|NCT02061449|"~     This study evaluates the safety and tolerability of the addition of immunostimulatory~     therapy consisting of focal radiation with or without the Toll-like receptor (TLR) agonist~     Poly ICLC in patients with cutaneous T-cell lymphoma (CTCL) receiving concurrent therapy~     with the histone deacetylase inhibitor (HDACI) Romidepsin.~   "
76083|NCT02061436|"~     Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly~     being performed in patients with advanced coronary artery disease, but there is limited~     information on the techniques utilized and the procedural outcomes. The goal of this~     multicenter, investigator initiated registry is to collect information on treatment~     strategies and outcomes of consecutive patients undergoing CTO PCI among various~     participating centers. The information collected will be used to determine the frequency of~     CTO PCI performed at the participating sites and examine the procedural strategies utilized,~     and the procedural (both immediate and during follow-up) outcomes.~   "
76084|NCT02061423|"~     The primary goals of this trial will be to determine the safety and immune activity of HER-2~     pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease~     post neoadjuvant therapy. Investigators will also explore the possibility of determining~     whether circulating tumor cells can be used as surrogate to assess response to vaccination.~   "
76085|NCT02061410|"~     The purpose of this study is to determine the effects of neuromuscular electrical~     stimulation (NMES) on neuromuscular and functional parameters in elderly with knee~     osteoarthritis.~      The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve~     healthy status of elderly with knee osteoarthritis.~   "
76086|NCT02061397|"~     The purpose of this research study is to see if simvastatin can be taken safely in patients~     with either LAM or TSC, who are already being treated with everolimus or sirolimus. This is~     the first step in looking at simvastatin as a drug that may help patients, by impacting the~     growth and survival of cells that make up the lung lesions that cause problems in LAM and~     TSC patients. The study also seeks to learn more about how simvastatin works, when given to~     patients being treated with everolimus or sirolimus, and to evaluate the safety and any~     potential benefit to patients taking this 2-drug combination.~      The primary objective of this study is to determine the safety of simvastatin in the~     treatment of LAM-S or LAM-TS in patients on a stable (for at least 3 months) dose of~     sirolimus or everolimus.~      Secondary objectives include:~        -  To assess the effect of simvastatin on forced expiratory volume in 1 second (FEV1).~        -  To assess the effect of simvastatin on forced vital capacity (FVC).~        -  To assess the effect of simvastatin on diffusing lung capacity (DLCO).~        -  To assess the effect of simvastatin on vascular endothelial growth factor -D (VEGF-D)~          serum levels.~        -  To assess the effect of simvastatin with questionnaire- based assessments of dyspnea,~          fatigue, and quality of life (QOL).~        -  Assess signs of clinical benefit.~   "
76087|NCT02061384|"~     Men with infertility and normal hormone levels have few options for fertility treatment.~     Previous research work has suggested that men with infertility may have low levels of the~     active form of Vitamin A, called retinoic acid, in their testes. We think that giving men~     with low sperm counts retinoic acid may increase their sperm counts and improve their~     chances of fathering a pregnancy. We want to see if retinoic acid administration over twenty~     weeks can increase sperm production and help infertile men become fathers without the need~     for In vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also~     want to see if adding calcitriol with retinoic acid will improve sperm motility in a sub-set~     of subjects.~   "
76088|NCT02061371|"~     Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic~     muscles of patients with sequelae of stroke.~   "
76089|NCT02061358|"~     The objective is to evaluate the safety and tolerability of a single-ascending oral dose of~     UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption~     and elimination following a single dose of UV-4B in healthy subjects.~   "
76090|NCT02061345|"~     Mild cognitive impairment (MCI) with ageing is thought in part to be related to reduced~     serum sex hormones which is well-recognized, especially in females, but poorly understood.~     International studies assessing hormone replacement therapy (HRT) to prevent/reduce MCI are~     ongoing. MCI leads to morbidity, reduced quality of life and substantial healthcare costs.~     The commonest therapeutically induced reduction in sex hormone level in men is treatment of~     prostate cancer (PCa). PCa is androgen dependent and androgen deprivation therapy (ADT)~     suppressing testosterone to castrate levels is key therapy for advanced disease. About one~     million men worldwide have received ADT for PCa, mostly using luteinising hormone releasing~     hormone agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps~     4% of Caucasians may be castrated. MCI as a side effect of castration in men remains poorly~     researched. This study aims to demonstrate that pathological changes occur in the brains of~     a significant proportion of prostate cancer patients subjected to ADT that correlate with~     MCI symptoms. Highlighting the pathological changes of MCI should improve understanding and~     interventions for slowing/preventing MCI in PCa survivors. Brain scans employing positron~     emission tomography (PET) imaging technique will be used to detect the presence of~     pathological changes in the brain that relate to ADT induced MCI. MCI will be assessed by~     neuropsychological assessments (standard paper-based questionnaires and online) and its~     neural basis will be investigated using magnetic resonance imaging (MRI).~   "
76091|NCT02061332|"~     Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by~     intranodal, intralesional, or both routes of administration. The primary objective will be~     safety and administration with secondary objectives of immune activation and clinical~     response.~   "
76092|NCT02061319|"~     The main purpose of our project is to see if a 12-week program of Nordic walking is better~     than standard exercise therapy for increasing exercise capacity (measured by how far people~     can walk in 6 minutes) and increasing quality of life (measured by having people fill out~     two questionnaires). We will also see if Nordic walking: improves heart performance~     (measured by heart ultrasound); improves how active people are (measured by an activity~     monitor); increases aerobic fitness (measured by a treadmill test); improves body~     composition (measured by waist size); and reduces hormone levels in the blood.~   "
76093|NCT02061306|"~     Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in~     wheat, rye, and barley. It is well known that many factors contribute to the development of~     CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we~     will consider as many of these factors as possible and study how they each contribute to~     disease development. If the investigators find that any one factor, or combination of~     factors, increases the risk of developing CD, we will be able to apply this information and~     help prevent or detect disease in high-risk children in the future.~   "
76094|NCT02061293|"~     Several lines of evidence suggest that classic hallucinogens such as psilocybin can~     facilitate behavior change in addictions such as alcohol dependence. The proposed~     investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group)~     contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in~     the context of outpatient alcoholism treatment.~   "
76095|NCT02061280|"~     Asthma is an inflammatory disease that imposes a significant burden affecting an estimated~     300 million persons and 20% of all children worldwide. It is one of the most common chronic~     diseases of childhood and is a leading cause of school absenteeism. There continues to be a~     great need for clinical trials in asthma but traditional clinical trials are expensive and~     reasons cited by patients for non-participation are extra inconvenience and logistical~     barriers. Study designs which are patient centered and reduce trial costs are needed. The~     long-range goal of this application is to transform the paradigm of clinical research into a~     more efficient and cost-effective enterprise by capitalizing upon current widely used mobile~     electronic means of communication and information transfer.~      This innovative project is a streamlined clinical trial that will run concurrently with a~     nearly identical traditional clinical trial, Long-acting Beta Agonist Step Down Study~     (LASST) which will allow for direct comparison of processes and outcomes between the~     streamlined and traditional approach. Children 12 to 17 years old with asthma will be~     randomized to participate in this project (streamlined trial) or LASST (traditional trial).~     In this proposal we will: measure comprehension of study information using an original~     questionnaire, Research Participant Assessment (developed at Nemours), following a parental~     permission/assent process delivered over the internet in a dynamic interactive multi-media~     format (Specific Aim 1); measure the efficiency of participant driven data entry from home~     into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality~     of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad~     (Specific Aim 2); test whether the streamlined approach has a trial effect by comparing~     the differences in Asthma Control Test (ACT) scores following 12 weeks of study drug~     treatment in children randomized to this project compared to LASST. We will collect effort~     reporting data to compare personnel costs between the trials. If this streamlined project~     lacks a trial effect and reduces costs compared to LASST, the methodologies would be~     generalizable to studies which include adults and other diseases.~   "
76105|NCT02061150|"~     Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict~     criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS)~     sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are~     asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due~     to risk factors alone, to determine the number of newborns having positive blood cultures,~     and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.~   "
77465|NCT02043418|"~     This study aims to assess the long-term outcomes of children infected with HIV, having~     participated in the ANRS 12140 PediacamI study, in terms of: clinical and immunovirological~     response to ARV therapy, long-term ARV tolerance, and the impact of family environment and~     lifestyle on adherence to ARV treatment.~   "
76096|NCT02061267|"~     The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD)~     risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack~     of habitual physical activity and certain dietary patterns, including high-saturated fatty~     acids (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk~     reduction is related with monounsaturated fatty acids (MUFA), mainly from olive oil, and~     omega-3 polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for~     nicotinamide phosphoribosyltransferase (NAMPT), has also emerged as a nutritional~     intervention strategy for prevention of CVD.~      NAMPT has been shown to exert activities of central importance to cellular energetics and~     innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of~     nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can~     regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released~     by a variety of cells, and elevated levels can be found in the systemic circulation of~     subjects with a range of inflammatory disorders.~      Recent evidences suggest that, primarily due to its high MUFA content, olive oil is useful~     as an optimal fat for the modulation of CVD risk factors in the postprandial state. In~     addition, NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a~     potential regulatory role for fatty acids on NAMPT expression has been proposed.~      The global aim of the project is to assess whether olive oil (MUFA), compared to other~     dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have~     benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important~     novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic~     syndrome. This aim is expected to be achieved in one principal objective:~      To elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA)~     meals supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on~     leukocyte inflammatory response in subjects with metabolic syndrome.~   "
76097|NCT02061254|"~     Explorative study on a medical device with two steps. The first pilot step will be on 8~     patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to~     assess the feasibility of measures by high resolution transient elastography on these~     pathologic skins, and to define 3 areas for measures.~      The second step will be on 136 participants (48 healthy volunteers, 48 with venous~     insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to~     quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous~     fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy~     skin.~   "
76098|NCT02061241|"~     Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as~     an effective treatment for heart failure. Unfortunately up to 45% of patients do not~     respond, with no improvement in symptoms or cardiac size. Reducing the proportion of~     non-responders has become the key research focus in CRT.~      Targeting the position of the left ventricular (LV) pacing lead within the coronary vein~     network has previously been shown to increase the proportion of responders to CRT. Several~     techniques have been tried for targeting lead position, of which the best investigated are~     the use of speckle-tracking echocardiography to target the lead position to the site of~     latest mechanical activation of the left ventricle, and the use of invasive monitoring to~     select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP~     occurs. Both techniques are limited by groups of patients in whom the techniques are not~     possible or provide limited useful information.~      The relationship between these two measures is unknown - there are no previous studies that~     have investigated correlation between the site of latest mechanical activation determined by~     echo and the site of maximal AHR. It is likely that a hybrid technique using both of these~     investigations might allow optimal lead positioning in more patients, or that if the~     information is shown to be equivalent, more streamlined techniques can be designed.~      This study will also be able to contribute towards several important secondary questions. In~     particular the investigators will study the possibility of using non-invasive cardiac output~     monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure~     monitor wire. The investigators also wish to assess whether the site of latest mechanical~     activation is changed by right ventricular pacing.~   "
76099|NCT02061228|"~     A randomised controlled open-label clinical trial to assess the effect of artificially~     induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy~     rate of an antagonist downregulated in-vitro fertilisation cycle~   "
76100|NCT02061215|"~     Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions~     and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years)~     renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral~     load measurements will be performed at baseline prior to transplant (within 1 week),and then~     at 3, 7 and 10 months after transplant. It is expected that the patient will receive~     anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will~     reflect responses after release from antiviral suppression. Each patient will serve as~     their own control, with comparisons made between measurements at baseline and then at each~     timepoint.~      Blood from 10 patients in each age group will be studied, to collect virologic and immune~     response data:~        -  CYTOF (broad array of measurements)~        -  Tetramer assays (requires recipient HLA type of A1, A2, B7)~        -  CMV viral load PCR~        -  Response to pneumococcal antigens and inactivated influenza virus~      In addition, clinical data will be collected at the time points indicated,particularly renal~     function and the presence/absence of acute rejection.~   "
76101|NCT02061202|"~     The proposed research is designed to test the global hypothesis that inhaled corticosteroids~     (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in~     adults with SCD who wheeze, but do not meet criteria for a diagnosis of asthma. The specific~     aims of this proposal are 1) Conduct a feasibility study - a randomized controlled trial of~     ICS for adults with SCD who do not meet criteria for a diagnosis of asthma but report~     recurrent cough or wheezing, 2) Measure the effects of ICS on biological correlates of~     pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as~     determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian adaptive~     clinical trial design for therapeutic trials in SCD in preparation for designing a~     definitive trial of ICS. These aims have the potential to 1) change the standard of care for~     individuals with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis~     of non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability~     of innovative clinical trial designs to overcome the challenges that have hindered~     therapeutic innovation for SCD.~   "
76102|NCT02061189|"~     This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3~     Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific~     exercise should promote motor skills of trained patients, as we have observed in different~     mouse models. Patient's motor skills will be assessed using different scales including MFM~     and Hammersmith.~      This clinical trial attempts to develop a new non-invasive motor scale with sophisticated~     instruments.~      This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of~     currently available scales.~      In addition, the study attempts to validate a questionnaire on post-exercise physical~     well-being.~   "
76103|NCT02061176|"~     A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open~     Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the~     study is to evaluate the long-term effect on haemorrhoidal symptoms one year~     postoperatively.~      Secondary endpoints are postoperative pain, complications, effect on anal continence,~     recovery and return to normal activity, quality of life and health cost analysis.~   "
76107|NCT02061124|"~     Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute~     essential components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is~     likely that modification of the enterohepatic circulation of bile acids can lead to changes~     in gut hormone secretion or gut bacteria composition and consequently affect glucose~     homeostasis.~      The current study is a human interventional study with 7-day ingestion of a bile acid~     sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is~     to examine how (and if) bile acid sequestration can influence postprandial glucagon-like~     peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2~     diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a~     phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with~     chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic~     control in patients with chronic kidney disease and type 2 diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in the postprandial gut hormone secretion and gut bacteria~     composition. The current study will help to clarify this hypothesis and improve our general~     understanding of the association between bile acid circulation and signalling, gut hormone~     secretion, gut bacteria and glucose metabolism.~   "
76108|NCT02061111|"~     Previously, studies have shown that children of women with thyroid autoantibodies experience~     more birth complications and poorer health in their first days. Studies have also shown~     later signs of cognitive developmental challenges (risk of attention deficit/hyperactivity~     problems) among children of mothers with autoimmune thyroid disease. In Denmark there is no~     formalized screening or treatment of subclinical thyroid disease - with or without Thyroid~     Peroxidase Antibodies (TPO-antibodies) - among pregnant women.~      The hypothesis of this study is that the offspring of women with subclinical thyroid disease~     have a mitochondria-dysfunction which leads to more complications during birth, poorer~     health and well-being in the early childhood. The investigators will test this by recruiting~     mothers by a blood sample in the third trimester of pregnancy, screen the cord blood at~     birth and later on test the children with Bayley test two times in the early childhood.~   "
76109|NCT02061098|"~     The investigators objective is to carry out a placebo-controlled, dose-response, randomized~     clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular~     disease risk in overweight adult subjects upon the consumption of pomegranate extract.~      The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such~     as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory~     markers. The correlation between the effect exerted and the subjects' microbiota (capacity~     to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of~     urolithins on the effects.~   "
76110|NCT02061085|"~     Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy~     and tolerability of first line single agent Eribulin in patients with HER2-negative~     metastatic breast carcinoma previously exposed to taxanes for early stage.~      The primary objective of the study is to determine the median time to progression achieved~     with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit~     rate, time to treatment progression, duration of response and toxicity profile.~   "
76111|NCT02061072|"~     The aims of this trials are:~        1. to collect published and unpublished individual classic pharmacokinetic data~          (individual patient data from independent investigators and pharmaceutical companies)~        2. to make available population pharmacokinetic models for the concentrates derived from~          the data collected~        3. to develop a web based application intended to use the above models to calculate~          pharmacokinetic parameters for individual patients, and~        4. to test the system functionality via simulation of the use of the prototype by use of~          faked test data.~   "
76112|NCT02061059|"~     The purpose of this study is determine whether the use of plantar pressure measurements in~     the production of customized therapeutic footwear for patients with diabetes and a history~     of foot ulceration results in lower production costs and more pressure relief, compared to~     the standard production. A secondary objective is to explore if a difference in durability~     can be observed in pressure reduction and development of (pre-) ulcerative lesions between~     the shoes produced with and without plantar pressure measurements.~   "
76113|NCT02061046|"~     To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea~     syndrome.~   "
76114|NCT02061033|"~     Patients with hemophilia who have the same level of deficient factor(s) may express~     different severity of clinical presentation and bleeding tendency. Therefore a test which~     could determine overall hemostasis rather than simple concentration of a single deficient~     factor may correlate better with clinical phenotype in these patients.~      The investigators will therefore study the usefulness of global hemostatic methods~     (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot~     structure) and microparticles in the prediction of severity of bleeding and estimation of~     response to the treatment in patients with hemophilia.~      Since hemophilia patients on prophylactic treatment virtually do not bleed, additional~     patients who are treated on demand only will be included enabling to study possible~     modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin~     activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will~     correlate both those factors and clinical severity with global hemostatic methods.~      The investigators expect to prove that individual tailoring of the treatment, which may~     enable lowering the prophylactic dose of factor concentrate without increasing the risk of~     bleeding, is justified in some hemophilia patients. This approach would reduce the amount of~     necessary factor concentrate in certain patients and decrease the cost (which represents~     extensive burden for health care systems) of treatment without potential risk for the~     patients.~   "
76115|NCT02061020|"~     Study of the effects of smoked cannabis consumption on performance on a driving simulator~     and reaction time. The study aims to explore the relationship between concentrations of~     cannabis in the blood, driving performance and reaction time.~   "
77466|NCT02043405|"~     The investigators will use exercise training and weight loss to discover localized lipid~     species related to diabetes risk in people.~   "
76116|NCT02061007|"~     The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron~     emission tomography (PET) imaging can be used to help doctors determine how much oxygen a~     tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in~     the current study. If the study is successful, then imaging can be used to determine a~     tumor's oxygen status even in patients who are not getting surgery.~      Investigators want to find out how much oxygen is in the participants tumor based on how~     much pimo is present, and correlate this with the results of their MRI and~     18F-fluoromisonidazole (FMISO) PET scan.~      This study is also testing the investigational radioactive substance known as FMISO. FMISO~     is used during PET scans to help doctors see how much oxygen a tumor is getting.~     Participants might be asked to participate in an optional PET scan using FMISO.~   "
76117|NCT02060994|"~     Background: It is known that after Cesarean section is correlated with respiratory~     complication more, if done after 37-38 week of gestation than if done after 39 weeks or~     more.~      Goal: The aim of the current study is to find out if these respiratory complications extend~     to later life.~      Methode: Reviewing the patients' medical file, and collecting data about respiratory~     complication.~   "
76118|NCT02060981|"~     Investigators will conduct a randomized trial with patients, through one-on-one interviews,~     to evaluate their understanding of and willingness to use a decision support tool and to~     determine if receiving and discussing the decision support tool improves the likelihood that~     a patient is adherent to a new antihypertensive medication.~   "
76119|NCT02060968|"~     The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in~     Routine Clinical Practice~   "
76120|NCT02060955|"~     The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in~     patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed~     by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to~     standard Bevacizumab/Irinotecan second line treatments for these patients.~   "
76121|NCT02060942|"~     Determining fluid responsiveness in critically ill patients by measuring mean systemic~     filling pressure on the intensive care unit.~   "
76122|NCT02060929|"~     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to~     the medication) of intranasally (through the nose) administered esketamine using a device~     with and without a nasal guide in healthy participants.~   "
76123|NCT02060916|"~     This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions~     measured via continuous glucose monitoring and its adverse effect profile in humans.~   "
76124|NCT02060903|"~     The purpose of the study is to assess the efficacy, safety and tolerability of a single~     application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to~     the scalp and hair for 10 minutes at home.~   "
76125|NCT02060890|"~     This current study will use a new treatment approach based on each patient's tumor genomic~     profiling consisting of whole genome sequencing, exome analysis, and RNA sequencing as well~     as predictive modeling. This new treatment strategy has shown promising results in adult~     patients with other solid tumors.~      The current study will test the feasibility of a specialized Tumor Board assigning a~     treatment plan within 35 calendar days of obtaining tumor tissue. The treatment plan will~     take into consideration each patient's tumor molecular profile and predictive modeling as~     well as prior history and treatment(s), and other medical conditions of the patient.~   "
76126|NCT02060877|"~     The purpose of this study is to gain insight in the distress experience and quality of life~     of patients suspected of having a serious lung disease during the diagnostic phase and the~     period between diagnosis and start of treatment~   "
76127|NCT02060864|"~     In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten~     sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten.~     Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal~     fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have~     completed 3 test days, a blind interim analysis is performed by a third party based on which~     it is decided whether to proceed with the low AN-PEP dose.~   "
76128|NCT02060851|"~     There are wide variations in iron supplementation practices in NICU.Guidelines on paediatric~     Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.In our~     early study serum ferritin and TIBC were not statistically significant before and after~     intervention by used the dose of intravenous iron.In our study,we find twhether iron~     combined EPO can improve iron state in preterm.~   "
76129|NCT02060838|"~     Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease~     post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood~     is drawn from our patients pre-bypass after obtaining the arterial line and administered~     back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of~     heparin with protamine. In our practice we noticed some variability in the impact of ANH on~     postoperative bleeding; with some patients appearing to show more hemostasis after~     separation from CPB than others. This is a prospective study to find out if there is an~     optimal time period that guarantees the largest amount of functioning platelets and what is~     the best practice for drawing and storing of ANH to guarantee the largest amount of~     functioning platelets.~   "
76130|NCT02060825|"~     This project is evaluating the validity of regional saturation monitoring in evaluating~     changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in~     many institutions, including NCH. Advances in the technology and recent approval of the use~     of CASMED devices for this purpose will allow us to use this technology more effectively. We~     aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and~     post operative period for the hybrid procedure and the balloon atrial septostomy procedure~     (BAS).~   "
76161|NCT02060422|"~     Psychological problems are prevalent among patients with drug-resistant epilepsy. The~     bi-directional interaction between psychological well-being and seizure have been recognized~     in recent years. Reduction of psychological stress has the potential to improve seizure~     manifestation.~      The present study uses an assessor-blinded prospective randomized controlled trial to~     evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social~     support on improving psychological well-being, seizure control and cognitive performance~     among adult patients with drug-resistant epilepsy.~   "
76131|NCT02060812|"~     Purpose: The purpose of this study is to compare the result of combined sono-guided~     suprascapular nerve block (SSNB) and axillary nerve block (ANB) with isolated SSNB in~     postoperative pain following arthroscopic rotator cuff repair. Our hypothesis was that SSNB~     combined ANB would show a more effective anesthesia for arthroscopic rotator cuff repair as~     compared with SSNB only.~      Methods: Forty-two patients with rotator cuff tear who had undergone arthroscopic rotator~     cuff repair were enrolled in this study. Among them, 21 patients were randomly allocated~     into group I, and received SSNB and ANB with each 10mL ropivacaine. The other 21 patients~     were allocated into group II, and received SSNB with 10mL ropivacaine and ANB with 10mL~     normal saline. Visual Analogue Scale (VAS) pain score, patient's satisfaction (SAT), and~     Lateral Pain Index (LPI), etc was checked at postoperative 1, 3, 6, 12, 18, 24, 36, and 48~     hours.~   "
76132|NCT02060799|"~     Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing~     discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms~     patients can experience; and it is one of the main complaints in the patients presenting to~     the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac,~     pulmonary or metabolic etiologies or a combination of them, since several diseases can cause~     dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary~     disease (COPD).~      Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in~     heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure~     (HF) is one of the most important causes of morbidity and mortality in the industrialized~     world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general~     European population. The incidence increases rapidly with age, and in Europe.~     Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to~     hospital have been adequately described, in Europe and in the United States. The Euro Heart~     Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely~     hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for~     AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.~      This same sensation of breathlessness is what also drives patients with asthma and chronic~     obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD)~     exacerbation accounts for approximately 1.5 million ED visits in the United States per year.~     It is the third most common cause of hospitalization, with an estimated 726 000~     hospitalizations in 2000 in the USA. Previous studies have demonstrated important~     differences between guideline recommendations and actual management of COPD exacerbation,~     either in the ED or during hospitalization.~      The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low~     sensitivity of the clinical signs associated with the aging of the population and the~     variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients~     in the ED at the European level. Diagnosis, prevalence and treatment of the patients may~     vary among European countries.~   "
76133|NCT02060786|"~     This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in~     comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary~     syndrome.~   "
76134|NCT02060773|"~     To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients~     with septic shock.~      Hypothesis: Hepatic perfusion did not improved after EGDT in patients with septic shock.~   "
76135|NCT02060760|"~     Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1~     MI compared to contemporary cTnI assays.~      The primary objective of the study is to determine the performance of a high sensitivity~     cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic~     accuracy of type 1 acute myocardial infarction (AMI).~      The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will~     assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The~     sensitivity, specificity, positive predictive value and negative predictive value of the~     hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and~     potentially age derived 99th percentile upper reference limits (URL).~      Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and~     percent changes over time) for their ability to contribute to the negative predictive value~     and hence potentially lead to an earlier rule out of AMI (improved specificity).~     Additionally, investigators will assess delta changes of the hs-cTnI assay for their~     potential contribution to the clinical differentiation of type 1 and type 2 (supply demand~     mismatch) MIs.~      Lastly, investigators will compare the diagnosis of AMI based on the currently used~     contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the~     time to diagnosis.~   "
76136|NCT02060747|"~     Harrington's metaphorical depiction captures the essence of the problem : Osteoporosis care~     of fracture patients has been characterized as the Bermuda Triangle made up of~     orthopaedists, primary care physicians and osteoporosis experts into which the fracture~     patient disappears.~      The most effective way to achieve this goal is through implementation of coordinator-based~     post fracture models of care. Exemplar models have been refered to as Fracture Liaison~     Service (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) Osteoporosis Coordinator~     Program (Canada [9,10]) or Care Manager Programs (USA [11,12]).~      The objective of this trial is to assess efficacy of a new coordinator-based post-fracture~     program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis~     after fracture thanks to an optimal recommendations practice to reduce the incidence of~     secondary fractures.~      Men and women are included aged over 45 years with fragility wrist and hip fractures.~      Evaluation criteria are based on the evidence-based assessment (stratify risk, identify~     secondary causes of osteoporosis, fracture evaluation), the medication adherence, others~     prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number~     of falls.~      Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6~     months~   "
76137|NCT02060734|"~     To determine the efficacy of lidocaine injection of trigger points versus subcutaneous~     injection in patients with subacute whiplash associated disorder following injury.~   "
76138|NCT02060721|"~     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used~     for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)~   "
76139|NCT02060708|"~     Non-invasive human brain stimulation using weak transcranial direct‐current stimulation~     (tDCS) has been thousands of times in research studies over the past fifteen years as a~     therapy to help improve the effectiveness of repeated training sessions (e.g., hand~     exercises in the context of daily physiotherapy), due to its safety, tolerability,~     convenience and cost‐effectiveness. tDCS works by temporarily enhancing brain activity~     during performance of a specific task, helping with learning and training.~      The investigators will use magnetoencephalography (MEG) brain imaging to view the real‐time~     effects of high definition (HD) tDCS on several brain areas involved in vision, hearing,~     movement, and memory. The investigators hypothesize that changing the task (auditory, visual~     or memory task) but keeping the position of the electrodes over the motor cortex will result~     in modulation of brain activity in only the central target motor area, and not on non-target~     temporal, occipital or pre-frontal areas.~   "
76142|NCT02060669|"~     Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading~     cause of cancer deaths in Western countries. Approximately half of all patients develop~     metastatic disease and become candidates for the palliative chemotherapy which has been~     proved to prolong survival and improve quality of life (QOL) in patients with metastatic~     CRC. The most active chemotherapy regiments include oxaliplatin or irinotecan combined with~     fluoropyrimidines.~      With overall survival in metastatic CRC nowadays routinely around 2 years, the same~     intensity of therapy can hardly be maintained throughout the course of therapy. The~     continuum of care therefore mandates changes in therapy, with treatment breaks or phases of~     less-intensive maintenance therapy interspersed with periods of more-intensive therapy to~     control tumor progression. Thereby, chemo-holidays conceivably reduce the cumulative~     toxicities of chemotherapy, potentially prevent the unplanned, premature discontinuation of~     therapy, preserve the ability to administer further phases of therapy, potentially maximize~     the time on therapy, reduce cost, and could increase QOL for patients. Several trials have~     tested the influence of chemo-holidays on patient outcome, with various rules on when to~     stop which component of antitumor therapy as follows; 1) Completely stopping all therapeutic~     agents, giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2)~     Stopping only those agents associated with significant (cumulative) toxicity while~     continuing other agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin~     Neurotoxicity Prevention Trial [CONcePT]).~      Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine~     combine with oxaliplatin (XELOX) could prolong progression-free survival without~     deterioration of QOL and toxicities in patients metastatic CRC.~   "
76143|NCT02060656|"~     This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in~     second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised~     1:1 between R-GEM-P and LR-GEM.~   "
76144|NCT02060643|"~     Some patients with head and neck cancer or benign tumours of the head and neck receive~     radiotherapy to their neck as part of their treatment. The carotid arteries are often~     included in the radiotherapy as collateral structures. There is some evidence to show that~     radiotherapy to these blood vessels can result in thickening of the artery walls some years~     after treatment and increased risk of stroke or TIA in the future.~      Current research is now aimed towards detecting radiotherapy-related changes to the carotid~     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating~     these blood vessels if possible. The question of whether or not the use of preventive~     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is~     currently unanswered.~      The aim of this study is to measure the thickness (intima-medial thickness) of irradiated~     carotid artery walls and compare this to unirradiated arteries. There are many other causes~     for thickening of arteries (such as high blood pressure, high cholesterol levels and~     diabetes) and these may affect the ability to measure the effect of radiotherapy change to~     the artery wall. In order to address this, it is ideal to look at this process in patients~     who have only had one side of their neck treated and use the other side as a comparison. The~     study will also be looking for earlier signs of radiotherapy-related changes, such as~     stiffening of the artery wall, inflammation in the artery wall (a very early sign of~     radiotherapy-related change) and some markers in the blood that may indicate that this~     process is taking place.~      The null hypotheses of this study are:~        -  In irradiated carotid arteries, the mean intimal-medial thickness will be the same~          compared to unirradiated arteries.~        -  Serum biomarkers will not be elevated in radiation-induced carotid atherosclerosis.~        -  Development of radiation-induced carotid atherosclerosis is not affected by risk factor~          modulation (Aspirin, HMGCoA reductase inhibitors, smoking cessation).~        -  There is no difference in carotid arterial wall strain in irradiated carotid arteries~          versus unirradiated carotid arteries.~        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries~          as an early marker of atherosclerosis.~   "
76145|NCT02060630|"~     This study will compare the effectiveness of best available surgical treatment with best~     available endovascular treatment in adults with critical limb ischemia (CLI) who are~     eligible for both treatment options.~   "
76146|NCT02060617|"~     Recent research has shown that classifying patients with low back pain into treatment~     subgroups results in better improvements than treating all patients with low back pain the~     same. However, physical therapists may use different types of information to determine how~     to classify their patients. One method uses patient characteristics that have been shown by~     research to predict good results from a certain type of treatment. Another method uses~     specific impairments that the physical therapist identifies in a clinical exam to determine~     which treatment to provide. It is not currently known if one of these methods is better than~     the other. The purpose of this study is to determine if research-based classification or~     impairment-based treatment is more effective for treating patients with low back pain that~     has lasted less than 90 days in terms of improvements in pain and disability. The results of~     this study may help reduce the high financial cost associated with low back pain.~   "
76147|NCT02060604|"~     The addition of an anti-inflammatory agent could be a valid option for controlling choroidal~     neovascularization, as simply inhibiting VEGF addresses neither the multifactorial~     pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.~   "
76148|NCT02060591|"~     The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into~     account pain control, narcotic consumption, narcotic-related side effects, outcomes~     measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit~     analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of~     hospital stay and the need for physical therapy postoperatively, therefore, offsetting its~     higher price in comparison with Marcaine.~   "
76149|NCT02060578|"~     Cancer is the second cause of over-one-year-old children mortality after accident. Survival~     rate is more than 70%, but in some cases, curative treatments are not sufficient and~     palliative support is implemented for those children in end of life.~      Pediatric guidelines about the place of end-of-life care are varied. On European scale, home~     is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development~     program recommended home or initial hospital care unit. This program also supports~     implementation of mobile team rather than specific hospital units.~      In Brittany, a pattern of regional palliative care resource team has been implemented since~     2005. In oncology, further to the guidelines, end-of-life place of care is often discussed~     several times for each case. Sometimes occur a lot of returns between home and hospital,~     psychological difficulties, and difficulties to offer adapted care conditions. Finally, less~     than 30% of children in palliative care decease at home.~      The primary objective is to identify main determinants of the place of palliative care in~     pediatric oncology.~      The secondary objective is to clarify the factors of change comparing to the initial planned~     place.~      Intervention :~      Questionnaire completed by the parents Interview with the parents and the psychologist~     (University Rennes 2)~      Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative~     phase, that means 136 to 186 parents.~      Expected results and perspectives :~      Using both quantitative and qualitative methods, expected results are the followings:~        -  Identification of the objective and subjective factors, which influenced the decision~          of the place of care.~        -  Determination of the factors of change comparing to the initial planned place.~      Once identified, main factors could be the ones to pay attention to in order to help for~     initial decision, better anticipation of change of place and better guidance of palliative~     care organization wherever, at home or in hospital.~      Results would be new information for research on palliative care for children but also for~     adults.~      Finally, this work is part of an improving approach of palliative care, related to the~     development of open-care hospital networks. We can expect some public health impacts with~     new arguments to help for complementary recommendations.~   "
76150|NCT02060565|"~     The aim of this retrospective and prospective study is to evaluate the 20-year prognosis~     value of non-invasive methods for the diagnosis of chronic liver disease for predicting~     survival and complications of cirrhosis.~   "
76151|NCT02060552|"~     The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in~     combination with urate lowering therapy on joint pain intensity,urate control, global~     assessments of disease activity, self-monitored gouty acute flare times, inflammatory~     markers and symptoms improving related life quantity in gouty patients.~   "
76152|NCT02060539|"~     To obtain subjective and objective feedback on the clinical performance of Biofinity lenses~     after at least two weeks daily wear in existing contact lens wearers compared with their~     habitual lenses.~   "
76153|NCT02060526|"~     Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage~     disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence~     of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate,~     resulting in progressive neurodegeneration. Symptoms are usually first noted in the 1st or~     2nd year of life, although definitive diagnosis is often delayed, with an average age of~     diagnosis of 4.5 years. The disease is characterized by developmental delays initially,~     followed by neurological developmental arrest, then regression. These developmental deficits~     are typically associated with severe behavioral disturbances. Patients have a significantly~     reduced lifespan, with few surviving beyond the 2nd or 3rd decade.~      The purpose of this study is to evaluate the safety and efficacy of recombinant human~     heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis~     Type III A Disease.~   "
76154|NCT02060513|"~     Military service members and the U.S. veteran population face a growing and serious health~     threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling~     pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria~     are increasing significantly. They cause major complications and mortality, and drive up~     healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can~     actually pressure bacteria to develop resistance.~   "
76155|NCT02060500|"~     Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of~     medical therapy, many children are referred for surgical intervention. Techniques have~     evolved over the last 50 years; however, benefits in children remain the center of debate in~     many surgical forums. This is primarily owing to the high incidence of recurrence of reflux~     and need for revisions later in life. Some clinicians theorize that the pathophysiology of~     reflux in infants is different from that of the population at large, and that the~     traditional operation may not be the best suited for this patient population. We propose a~     study to test an alternative plication technique for modifying the gastro-esophageal~     junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that~     we will create a valve which will limit reflux without disrupting the diaphragmatic crura,~     thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of~     fundoplications which are too tight.~   "
76156|NCT02060487|"~     This is a blinded study in adult patients with PAH evaluating the relative effects of~     sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all~     three times per day [TID]). In addition, the relative effects on clinical worsening and~     6-minute walking distance (6MWD) will be assessed.~   "
76157|NCT02060474|"~     This therapeutical trial will be conducted in patients with the Allan-Herndon-Dudley~     Syndrome (AHDS), which is mutations in MCT8.~      MCT8 is a thyroid hormone (TH) transporter which is crucial for the transport of TH from the~     blood into different tissues. Dysfunction of MCT8 results in a lack of TH (hypothyroidism)~     in tissues that depend on MCT8 for TH uptake. This local hypothyroidism in the brain of~     these patients causes severe psychomotor retardation.~      In addition, TH serum parameters are highly abnormal in AHDS: high T3, low T4 and normal TSH~     levels. The high serum T3 levels cause local hyperthyroidism in tissues that do not depend~     on MCT8 for cellular transport of TH, resulting in a low body weight and reduced muscle~     mass.~      Currently, no adequate treatment is available for the AHDS. A T3 analog that does not depend~     on MCT8 for its cellular entry could, at least partially, restore the abnormalities found in~     AHDS. Several in vivo, in vitro and animal studies have shown that the T3 analog Triac is a~     very promising candidate:~        1. Triac binds to the same TH receptors as T3;~        2. Cellular uptake of Triac does not depend on functional MCT8. Hence, in AHDS patients~          Triac will also be available in tissues that require functional MCT8 for TH uptake,~          e.g. the brain;~        3. In vitro studies have shown that neuronal cells differentiate equally well in the~          presence of either Triac or T3;~        4. In Mct8 deficient mice, Triac is taken up by the brain and suppresses serum TSH levels;~          consequently, serum T3 and T4 levels were lowered;~        5. Triac is the treatment of choice in patient with the resistance to thyroid hormone~          (RTH) syndrome. Patient with RTH have high serum TSH and thyroid hormone levels, which~          shows strong similarities to the profile found in AHDS patients; the longstanding~          experience with Triac in RTH indicates its safety and tolerability .~      Thus, Triac treatment could result in normalization of the abnormal serum TH values in AHDS~     patients. Furthermore, Triac could replace the function of T3 in tissues that depend on MCT8~     for TH uptake (e.g. brain).~      The current trial will investigate if Triac treatment in ADHS patients~        1. reduces the toxic effects of the high T3 levels~        2. restores the local TH deficiency in brain.~   "
76158|NCT02060461|"~     Laser in situ keratomileusis (LASIK) is a safe and effective method for treating myopia,~     hyperopia and astigmatism. It is based on reshaping the cornea to focus the light closer to~     the macula. This method includes two steps: a corneal flap creation, which can be performed~     by a mechanical microkeratome or a femtosecond laser, and the reshaping of the cornea by~     another laser (Excimer laser).~      The corneal flap creation is a crucial step. Indeed, creating a flap weakens a large part of~     the anterior stroma. The accuracy of the LASIK flap thickness is a key safety consideration~     to reduce the likelihood of ectasia following LASIK. Femtosecond laser technology has~     significantly improved the results of LASIK flaps, with increased predictability, lesser~     induction of optical aberrations, and a better healing profile compared to microkeratome~     flaps, with similar visual acuity results.~      Femtosecond Laser technology has been extensively investigated for the last ten years for~     use in refractive surgery. Actually, four femtosecond laser devices are available to perform~     LASIK flaps, each of them having clinical benefits and limitations. A fifth, designed by~     WaveLight AG/Alcon Laboratories, Inc. (Erlangen, Germany/Fort Worth, Texas), is approved for~     human use by the United States Food and Drug Administration and has been just released in~     the US market. Its unique technical aspects, optimized scanning algorithms, and~     user-friendly patient interface, have already provided a high reproducibility for cutting~     three-dimensional tissues structures in porcine corneas. Furthermore, the device has been~     shown to minimize opaque bubble layer (OBL) formation. This condition is very common and~     responsible for a delay in the treatment, since it can obstruct the eye tracker.~      The objective of this study is to evaluate the visual outcome, accuracy, predictability and~     complications of LASIK flap creation using the new Wavelight FS200 Femtosecond laser and~     compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The~     primary outcome to be evaluated is the flap thickness accuracy.~   "
76159|NCT02060448|"~     The overall aim of this study is to begin establishing an effective treatment for~     individuals who engage in non-suicidal self-injury (NSSI), as there are currently no~     evidence-based treatments that directly target this problematic behavior. Existing~     treatments that have demonstrated initial promise in reducing NSSI consist of many skills~     embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI~     are not clear. Procedures that focus on one's emotions, particularly that aim to increase~     emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that~     lessens emotions), may be critical in effective NSSI treatment. The specific goals of this~     study are to investigate the effects of two specific emotion-focused treatment elements on~     NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical~     Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria~     for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core~     modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP;~     Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants'~     non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of~     four 50-minute individual weekly sessions of emotion awareness training or cognitive~     reappraisal. The study will use a single-case experimental design, and phase change will be~     determined based on each participant's changes in non-suicidal self-injurious thoughts and~     behaviors.~   "
76163|NCT02060396|"~     This study in healthy volunteers is the first step in developing a collaborative research~     program, which seeks to test the hypothesis that chemopreventive effect of acetylsalicylic~     acid (ASA) on colon cancer is due predominantly to its antiplatelet effect.~      The following features of the clinical evidence are consistent with the platelet-mediated~     hypothesis:~        1. The apparent saturability of the chemopreventive effect of ASA at low doses given once~          daily, found in long-term analyses of cardiovascular and adenoma recurrence randomized~          clinical trial, as well as in the vast majority of observational studies performed in~          different settings and with different methodology. A remarkably similar saturability of~          the cardioprotective effect of low dose ASA given once daily is explained by the~          irreversible nature of cyclooxygenase (COX)-1 inactivation in platelets, and limited~          capacity of human platelets for de novo protein synthesis.~        2. Given the short half-life of ASA in the human circulation (approximately 20 min) and~          the capacity of nucleated cells to resynthesize the acetylated COX-isozyme(s), it seems~          unlikely that a nucleated target could be suppressed throughout the 24-h dosing~          interval.~        3. One of the cardiovascular randomized clinical trial (Thrombosis Prevention Trial) in~          which the chemopreventive effect of ASA was detected on long-term follow-up, involved~          the administration of a controlled-release formulation of ASA (75 mg) with negligible~          systemic bioavailability.~        4. Enhanced platelet activation and thromboxane (TX)A2 generation in vivo has been~          demonstrated in patients with colorectal cancer and in Familial Adenomatous Polyposis~          patients.~      So, the main objective of this study is to assess the extent of acetylation at serine-529 of~     platelet COX-1 after the 1st and 7th dose of low-doseof enteric-coated ASA 100 mg daily.~     Changes of this novel biomarker of ASA action will be correlated to other known parameters~     of ASA PK and PD: i) Tmax, Cmax and AUC of ASA and salicylate in the peripheral circulation~     after oral dosing; ii) time to obtain the maximal antiplatelet effect by ASA and its~     persistence throughout the dosing interval as assessed by measuring the inhibition of~     platelet COX-1 activity in whole blood ex vivo, the inhibition of platelet aggregation in~     whole blood ex vivo and the inhibition of the systemic generation of TXB2.~   "
76164|NCT02060383|"~     The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and~     safely managed in majority of patients, including those with diabetes at start of~     pasireotide treatment.~   "
76165|NCT02060370|"~     The standard method for giving sunitinib is 4 weeks in which the patient receives the drug~     every day, followed by 2 weeks in which the patient receives no drug. These 6 week cycles~     are then repeated. However, side effects are often seen to increase and get worse during the~     4 weeks of treatment, especially during the last 2 weeks. Researchers want to learn if~     shortening the treatment cycles can help to decrease the frequency and severity of side~     effects.~      The goal of this clinical research study is to learn more about the safety of giving~     sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which~     they receive no drug. The side effects from and effectiveness of this dosing schedule will~     be studied and compared to those of the standard.~   "
76166|NCT02060357|"~     The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity~     Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting~     stent (Boston Scientific), in patients with diabetes.~      We plan to compare endothelial coverage and neointimal proliferation using OCT and compare~     this data to published results from conventional stents.~   "
76167|NCT02060344|"~     The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center~     epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in~     the prevalence and development of disease, and to identify risk factors playing a protective~     or harmful role in Hispanics/Latinos.~   "
76168|NCT02060331|"~     In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome~     nocturia. The International Continence Society (ICS) defines nocturia as having to wake at~     night one or more times to void. Though some of this nocturia may be secondary to~     obstructed bladder emptying, the investigators hypothesize that in some women compression of~     the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of~     that prolapse while the patient lays supine overnight results in nighttime post-obstructive~     diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and~     nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes~     obstruction due to descent of the bladder floor which leads to compression of the bilateral~     ureters between the uterus and the borders of the genital opening. No large prospective~     studies, however, have evaluated the possible impact of this phenomenon on patients or the~     possible post-operative changes following surgical correction of POP.~      Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding~     diaries, and urine studies, the investigators aim to evaluate the pre-operative and~     post-operative voiding habits and urinary parameters of women with severe pelvic organ~     prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which~     surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients~     with >90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or~     open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension,~     also offer high rates of success. The investigators aim to determine whether surgical~     correction of severe pelvic organ prolapse, to be defined as either with colpocleisis,~     laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous~     ligament suspension, results in improvement and/or resolution of nocturia and~     post-obstructive diuresis.~   "
76169|NCT02060318|"~     Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17~     cells and other immune cell types) or biomarkers can be used to predict the response or lack~     of response to treatment with Infliximab. If so, characteristics of the immune cells may~     also unveil the mechanisms behind lack of response to Infliximab.~      Design: a prospective, observational study with three arms. In the treatment group, 35~     patients with Crohn's disease about to start Infliximab-treatment are recruited. They have~     blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks~     of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated~     once. All treatment and follow-up are according to national guidelines, and data from this~     study is not used by the clinicians.~      Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is~     investigated using flow cytometry. From plasma and serum samples, various proteins~     (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor~     alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical~     history) are extracted from various registries.~   "
76182|NCT02060149|"~     The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB)~     is still high, even if these patients received certain strong anti-infection treatment such~     us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining~     fluid is mildly alkaline but airway acidification usually appears for the infection of~     XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if~     the circumstance including pH is changed. In the vitro study we observed that the inhibit~     effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within~     the scope of physiology. So the aim of this clinical study is to explore the effects of~     nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.~   "
76202|NCT02059889|"~     This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in~     identifying and localizing tumors in patients with non-small cell lung cancer undergoing~     radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify~     where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results~     of diagnostic procedures done before, during, and after radiation therapy may help determine~     how the location and volume of tumors changes over time and predict how the tumor will~     respond to therapy.~   "
76170|NCT02060305|"~     Primary Objective The efficacy of intra-articular bevacizumab injection for secondary~     prevention of recurrent hemarthroses for hemophilia patients who has had target joints with~     chronic synovitis. The safety profiles of intra-articular bevacizumab injection for~     hemophilia patients.~      Study Population Adult hemophilia patients who have had one or more target joints with~     chronic synovitis and recurrent hemarthroses.~      Investigational therapy: Intra-articular injection of Bevacizumab (20 or 40 mg/ 0.8 or 1.6~     ml/ dose) every month (28 days) for up to 4 months, depending on the improvement of target~     joint bleeding.~      Study Design The estimated study period is between Jan 2014 and Dec 2015. Totally 10 joints~     will be enrolled for this pilot study. Before enrollment, the joint(s) will be evaluated for~     their severity both clinically (by 10-point Pain Score, range of motion for the target~     joint, and World Federation of Hemophilia Score) and by MRI (using the compatible MRI scales~     developed by International Prophylaxis Study Group [IPSG]). Intra-articular injection of~     bevacizumab will be administered, after prophylactic factor supplementation, every month for~     up to four injections. In the first four patients, 20mg of bevacizumab will be administered.~     If there are no Gr 3 or Gr4 dose-limiting toxicities, bevacizumab dose will be escalated to~     40mg in the other 6 patients. Before every procedure, the plasma and the synovial fluid~     samples will be collected for VEGF quantification for the correlative biomarker study. After~     completing the protocol treatment, the efficacy parameters as well as the safety profiles~     will be evaluated.~   "
76171|NCT02060292|"~     Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to~     severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and~     is likely to profoundly influence an individual's ability to manage their disease.~      In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as~     the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD.~     Several large population studies have shown that COPD is a significant independent risk~     factor for myocardial infarction, with the effect most marked in early, mild disease.~      We propose to compare non-invasive MR brain imaging of white matter microstructure~     (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral~     small vessel disease (cerebral microbleeds), in COPD patients to smokers without COPD. In~     addition we plan to explore mechanisms of cerebral small vessel disease in COPD by looking~     for associations between arterial stiffness, end organ vascular damage and cognitive~     function.~   "
76172|NCT02060279|"~     This is a pilot study of children between the ages of 8 to 11 years of age who are obese and~     participating in an intense family based intervention with a family-focused multi-component~     lifestyle intervention. In addition, a beta-carotene supplement will be administered to~     randomized participants.~   "
76173|NCT02060266|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,~     metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy~     male subjects.~   "
76174|NCT02060253|"~     This phase I trial studies the side effects and best dose of ganetespib when given with~     paclitaxel, trastuzumab and pertuzumab in treating patients with human epidermal growth~     factor receptor 2 positive (HER2+) metastatic breast cancer (MBC).~   "
76175|NCT02060240|"~     The purpose of the study is to see if a twelve-week exercise intervention in overweight or~     obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to~     improved skeletal muscle capillary blood flow by improving substances that dilate blood~     vessels and result in improved insulin sensitivity.~   "
76176|NCT02060227|"~     The primary research question is to determine whether patients who undergo a stabilization~     of the shoulder using a novel decision-making algorithm (ISIS Score) have improved~     disease-specific quality of life at 1 year post-operatively, as measured by the Western~     Ontario Instability Index (WOSI) compared with patients who undergo stabilization using a~     conventional decision-making algorithm. Secondary outcomes include the American Shoulder and~     Elbow Surgeon's (ASES) score, and difference in recurrence rates of dislocation between the~     two decision-making algorithms.~   "
76177|NCT02060214|"~     Urinary urgency is the key symptom of overactive bladder (OAB). A critical barrier in~     understanding OAB is the lack of a method to separate urgency that derives directly from~     bladder filling or what we term tension sensor output and urgency that derives from~     abnormal brain interpretation. The central hypothesis is that measureable biomechanical~     parameters can directly affect the output (urgency) of the detrusor tension sensor.~      The development of novel cystometric tests for the improved diagnosis and treatment of OAB~     and for the potential identification of novel mechanistic targets in the pathophysiology of~     OAB.~   "
76178|NCT02060201|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and~     Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral~     administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered~     orally together in the fasted state and to demonstrate the BE of Saxagliptin and~     Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral~     administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered~     orally together in the fasted state. Demonstrating bioequivalence refers to showing that the~     FDC tablet and co-administration of the individual components yield similar blood~     levels/concentrations of the drug and are handled by the body similarly.~   "
76179|NCT02060188|"~     The purpose of this study is to examine if Nivolumab alone, Nivolumab in combination with~     Ipilimumab, or Nivolumab in combination with Ipilimumab and Cobimetinib, Nivolumab in~     combination with anti-LAG3 agent (BMS-986016), or Nivolumab in combination with daratumumab~     will demonstrate a meaningful objective response rate in patients with recurrent and~     metastatic colon cancer who also have a specific biomarker in their tumors.~   "
76180|NCT02060175|"~     We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between~     the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not~     been evaluated yet for both the Cilotax and DESyne and we first sought to decide the~     reference intervals using 40 samples (total 44 patients for each group considering 10%~     drop-out rate) as the pilot study.~   "
76181|NCT02060162|"~     This study aims to establish a cohort of patients starting antiretroviral therapy (ART) with~     chronic hepatitis B virus (HBV) infection and study the effect of chronic HBV on HIV- and~     liver-related outcomes according to ART regimen and site.~   "
76183|NCT02060136|"~     Urinary diaries have proven to be beneficial in assessing lower urinary tract symptoms~     (LUTS), however they have not achieved widespread acceptance. The likely reason is the fact~     that the pen and paper diaries are labor intensive for both patient (need to carry a pen and~     paper and record each event) and doctor (need to transfer, summarize and analyze the data).~      Hypothesis: Electronic voiding diary, would automate the recording and analysis of data,~     expedite the process, improve its accuracy and cost effectiveness.~      Electronic recording of lower urinary tract symptoms (SUF) uses wireless phone and web based~     technologies to record LUTS remotely and store the data on a secure website which can be~     accessed by the doctor or patient whenever needed. The goal of this study was to compare its~     validity and reliability to the traditional micturition chart (MC) recording method - the~     current gold standard where the patient records the time of micturition and degree of~     urgency using a pen and paper.~   "
76184|NCT02060123|"~     The purpose of this study is to evaluate the effect of a qigong intervention program on~     telomerase activity in Chinese women with a history of intimate partner violence.~   "
76185|NCT02060110|"~     The registry is designed to determine the long-term mortality and morbidity benefit as a~     result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable~     Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The~     registry will collect data on patients that previously participated at MADIT-CRT sites~     within Europe through five years of participation from their orginal enrollment in the~     MADIT-CRT IDE study.~   "
76186|NCT02060097|"~     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the~     intrinsic aging process, and accounts for the majority of age-associated changes in skin~     appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies~     utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have~     been examined.~      Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and~     have a higher antioxidant capacity. The present study is designed to investigate the effects~     of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration,~     elasticity and photosensitivity.~   "
76187|NCT02060084|"~     Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment~     from microbial colonization. As the effects of diet, intestinal flora is rapidly changed.~     Preterm children significantly delay in the establishment of normal flora,during~     hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay,~     combat disease and other factors. In this study, hospitalized preterm children for the~     study, the prospective randomized double-blind controlled study, to find oral intestinal~     bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution,~     and further show intestinal bacteria in premature children case group.~   "
76188|NCT02060071|"~     There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the~     aortic valve.~   "
76189|NCT02060058|"~     The aim of this study is to explore the efficacy and safety of boceprevir -based triple~     therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to~     previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.~   "
76190|NCT02060045|"~     The objective of the investigators work was to evaluate the impact of 4 sequentially~     implemented measures for preventing VAP in a major heart surgery ICU. The measures were a~     specific training program, aspiration of subglottic secretions (ASS), introduction of an~     inclinometer to improve the semirecumbent position, and reinforcement of oral care with~     chlorhexidine.~   "
76191|NCT02060032|"~     Background: Statins are the recently evolved agents that aid in periodontal regeneration and~     ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are~     specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The~     present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2%~     SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic~     periodontitis.~      Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2%~     ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index~     (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment~     level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage~     radiographic defect depth reduction was evaluated using computer-aided software at baseline,~     6 months and 9 months.~   "
76192|NCT02060019|"~     This study is designated to evaluate the pharmacokinetic interactions of amlodipine~     besylate, valsartan and rosuvastatin in healthy male volunteers.~   "
76193|NCT02060006|"~     Background: Non-Steroid Anti-Inflammatory Drugs (NSAIDs) reduce pain and inflammation by~     inhibiting cyclooxygenase, an enzyme in the pathway for formation of prostaglandins and~     thromboxane. Prior studies have proven the role of ibuprofen (an NSAID) in modulating lung~     injury and decreasing pulmonary damage in cystic fibrosis. While there has been an intense~     effort by the scientific community to define the best treatment strategies for tuberculosis~     immune reconstitution inflammatory syndrome (TB-IRIS), to our knowledge there is no~     available study evaluating preventive strategies using anti-inflammatory agents for TB-IRIS,~     a highly morbid complication in HIV-infected TB patients initiating antiretroviral therapy~     (ART).~      Design and Methods: We propose to conduct a single center double-blind placebo-controlled~     randomized trial to investigate the efficacy of daily self-administered Meloxicam (a NSAID)~     versus placebo for prevention of Tuberculosis associated Immune Reconstitution Inflammatory~     Syndrome (TB-IRIS). A total of 150 HIV-infected adults who are treated for Tuberculosis for~     at least 2 weeks and about to initiate HIV treatment at Brewelskloof Hospital, Worcester,~     and Tygerberg Teaching Hospital, Cape Town, will be randomized to one of the following~     treatments: Meloxicam 7.5 mg tablet once-a-day, the experimental arm, versus Placebo tablet~     once-a-day, the control arm, for 8 weeks. All patients will be followed up for 12 months.~     Primary efficacy outcome: The decrease of the incidence of paradoxical TB IRIS by at least~     20%; Primary safety outcome: The proportion of patients who temporarily or permanently~     discontinue Meloxicam due to any adverse event (e.g. dyspepsia or gastro-intestinal upset).~     Secondary outcomes are: 1) the proportion of patients in each arm with the following~     indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III,~     presence of local or disseminated suppuration/abscess of any site, unscheduled clinic~     visits, hospitalizations, missed more than a day at work, etc; 2) The incidence of other~     types of IRIS (e.g. Kaposi Sarcoma or cryptococcal meningitis).~      This study will provide important and novel data on the feasibility and efficacy of using a~     cheap, widely available NSAID used in both developed and developing countries, as a~     preventive intervention for TB-IRIS that could be quickly put into practice if proven to be~     effective~   "
76203|NCT02059876|"~     The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly)~     carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.~   "
77506|NCT02042885|"~     The purpose of this study is to determine the tolerability profile of OPB-111001 and to~     determine the most suitable dose of OPB-111001 in patients with advanced cancer~   "
76194|NCT02059993|"~     Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous~     study has suggested that OSA significantly increases cardiovascular morbidity and mortality,~     especially in patients with pre-existing cardiovascular disease.The standardized treatment~     of moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term~     trials indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies~     have a relative short duration with only but few more than one year. In our opinion, they~     are not sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact~     of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment~     could reduce blood pressure and improve metabolic disorder in patients with coronary heart~     disease (CHD)and OSA.~   "
76195|NCT02059980|"~     Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are~     characterized by the marked difficulty in inhibiting unwanted or inappropriate responses.~     There is compelling evidence that poor response inhibition is a core cognitive feature of~     OCD and its related disorders, but no effective intervention exists that directly attempts~     to address this problematic cognitive deficiency. This study will examine the feasibility~     and clinical utility of a computerized cognitive training program designed to improve~     response inhibition among individuals diagnosed with OCD or trichotillomania.This training~     program offers systematic practice of response inhibition in the form of a 40-level computer~     game. Individuals with these conditions will be randomized to either 8 sessions of (a)~     computerized response inhibition training (RIT) or (b) placebo computer training (PLT). We~     hypothesize that RIT will outperform PLT in improving response inhibition capabilities and~     reducing relevant clinical symptoms. In sum, this project is expected to generate important~     knowledge to guide the development of effective computer-based treatment approaches that may~     help reduce critical problems of existing treatments such as suboptimal patient retention~     and treatment under-utilization, thereby improving overall treatment response rates among~     individuals suffering from OCD and related conditions.~   "
76196|NCT02059967|"~     This phase I trial studies the side effects and best dose of image-guided adaptive radiation~     therapy using active breathing control when given together with chemotherapy and~     simultaneous integrated boost in treating patients with stage IIA-IIIB non-small cell lung~     cancer that cannot be removed by surgery. Image-guided adaptive radiation therapy aims~     radiation therapy right at the tumor so that higher radiation doses can be given without~     causing bad side effects. Giving these higher doses may help control the tumor better.~     Breathing causes organs and tissues, including the tumor, to move within the chest. Active~     breathing control may reduce the volume that needs to be treated. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     image-guided adaptive radiation therapy using active breathing control with chemotherapy and~     simultaneous integrated boost may be an effective treatment for non-small cell lung cancer.~   "
76197|NCT02059954|"~     Hysterectomy for benign indication is one of the most common surgical procedures in women.~     Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but~     the proportion of laparoscopic (and robotic) hysterectomies is increasing.~      This study will compare a range of clinical and subjective outcomes of vaginal vs. total~     laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return~     to work as well as cosmesis, quality of life and sexual health.~   "
76198|NCT02059941|"~     Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury~     (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for~     the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial~     pressure (ICP) monitors to assess ICH and guide intervention. Unfortunately, only a small~     percentage of the world has the resources and capability to routinely monitor ICP.~      The objective of this proposal is to create and test guidelines for the treatment of severe~     TBI in the absence of ICP monitoring.~   "
76199|NCT02059928|"~     In emergency situations, access to the venous system is essential in order to administer~     fluids and medication and to monitor patients. When peripheral veins are difficult to access~     or the patient's condition requires certain medications, or monitoring, central venous~     catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared~     to peripheral catheters. The technique of intraosseous (IO) infusion has been used by~     healthcare professionals for several decades, but recently has gained wide popularity in the~     emergency care settings. This technique allows providers to secure a needle in the bony~     matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into~     the intramedullary space. The ability to monitor a patient's blood pressure through an~     intraosseous needle is unknown. The primary objective of this study is to describe the~     relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values,~     including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial~     pressure (MAP), and central venous pressure (CVP).~   "
76200|NCT02059915|"~     To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs.~     Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers~   "
76201|NCT02059902|"~     Thermal injury results in one of the most intense and prolonged forms of pain the body can~     experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and~     their use in the perioperative period has been the mainstay of treatment; although~     medication requirements in burn patients are often underestimated. More medication may not~     be the answer, as relatively large doses of short acting opioids in the operative theater~     are associated with greater postoperative opioid consumption and higher pain scores.~     Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and~     allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic,~     antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine~     has been used for perioperative pain management in a variety of surgical procedures. The~     design of this study will examine if lidocaine will reduce the pain scores and narcotic~     utilization in patients undergoing surgical procedures for burn injuries. The intervention~     group will receive a bolus dose of lidocaine followed by a continuous infusion over 24~     hours. The control group will get an equal volume of saline. The investigators will compare~     pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area~     (BSA) grafted.~   "
76204|NCT02059863|"~     A large number of children in developing countries lack access to known effective~     interventions. Almost 9 million die each year before reaching their fifth birthday, and over~     200 million children who survive fail to achieve their full growth or developmental~     potential, trapping them in a cycle of continuing disadvantage. The goal of SPRING,~     Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative~     approach to close this access gap, in two of the worst affected countries India and~     Pakistan, using community based agents. Extensive formative research will be carried out to~     help ensure that the content and approach of the SPRING intervention is feasible,~     acceptable and appropriately targeted. Findings will be reviewed at an intervention~     development workshop with local and international stakeholders and experts, and the agreed~     intervention piloted with a few community based agents and their supervisors. Cluster~     randomised controlled trials will be carried out in each setting to evaluate the impact of~     SPRING on child growth, development and survival. The programme will include process and~     economic evaluations to provide information on the total cost of the intervention and its~     cost effectiveness, as well as development of a framework with lessons learned for~     implementing SPRING in other settings.~   "
76205|NCT02059850|"~     This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells~     after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round~     cell liposarcoma. Placing a gene that has been created in the laboratory into white blood~     cells may make the body build an immune response to kill tumor cells. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1~     specific T cells with cyclophosphamide may kill more tumor cells.~   "
76206|NCT02059837|"~     This study is conducted to evaluate its morphologic reproliferating patterns in patients~     with pterygium treated with the excision and conjunctival autograft.~   "
76207|NCT02059824|"~     The purpose of this study is to determine normal eyelid sensation distribution using a~     Cochet-Bonett Aesthesiometer.~   "
76208|NCT02059811|"~     More than two-thirds of US adults with chronic kidney disease (CKD) have uncontrolled~     hypertension. Both hypertension and CKD are major independent risk factors for~     cardiovascular disease, which is the leading cause of death in the US. Fortunately, lowering~     blood pressure to recommended treatment targets not only slows the progression of CKD, but~     also improves cardiovascular outcomes. Controlling hypertension in this patient population,~     however, can be quite challenging. A lifestyle modification that effectively reduces blood~     pressure in both pre-hypertensive and hypertensive adults is the Dietary Approaches to Stop~     Hypertension (DASH) diet.~      The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers~     blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated~     glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet~     can be safely consumed by this patient population.~   "
76209|NCT02059798|"~     Hypotheses:~      Decompressive surgery of cervical myelopathy will improve bladder function.~      Decompressive surgery of cervical myelopathy will improve sexual function.~   "
76210|NCT02059785|"~     This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study.~     Chinese subjects with Ischemic Stroke.~   "
76211|NCT02059772|"~     The primary objective of this study is to evaluate if a combination therapy with micropulse~     diode laser treatment shows non inferiority on visual acuity within 12 months in comparison~     to standard therapy (intravitreal injection of ranibizumab only).~   "
76212|NCT02059759|"~     The primary objective is to evaluate in ALS patients the regulatory T cell early response to~     two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days~     comparatively to placebo.~   "
76213|NCT02059746|"~     This is an ancillary study to the JUMODA (National Prospective and Comparative Study on~     the Mode of Delivery of Twins) study: please see NCT01987063.~      The main objective of this study is to investigate the role of the mode of delivery (vaginal~     versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months~     post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.~   "
76214|NCT02059733|"~     This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients~     with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients~     with ET, and 10 patients with DT.~   "
76215|NCT02059720|"~     A multicentre, prospective, open-label clinical study, including a randomized controlled~     study in low or intermediate-risk group patients, and a cohort study of maintenance~     treatment with decitabine after ASCT.~   "
76216|NCT02059707|"~     The objective is to assess the effectiveness of permanent exclusion of the LAA with the~     LARIAT RS Suture Delivery Device and accessories in AF patients.~   "
76217|NCT02059694|"~     To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local~     anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.~   "
76218|NCT02059681|"~     The purpose of this study is to evaluate whether endocavitary intramyocardial injection of~     autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse~     events, with follow-up assessments extending up to 1 year after enrolment.~   "
76219|NCT02059668|"~     The aim of this clinical research project is to validate the prognostic impact of potential~     biomarkers on loco-regional control of locally advanced head and neck cancer after~     definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.~      Potential biomarkers from a previous retrospective study will be validated in this~     prospective study.~   "
76220|NCT02059655|"~     The purpose of the study is to establish whether Bimatoprost eye drops are effective in~     reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of~     life in patients with TED. Current standard NHS treatment/care for inactive TED is~     artificial tears (used as the placebo in this study) or surgery if appropriate.~      The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually~     used for glaucoma. Therefore the current trial's indication is outside its licenced~     indication. The Investigational Medicinal Product (IMP) will be used according to its~     licenced dosage and form. This is the first time that Bimatoprost will be used in the~     treatment of TED~   "
76221|NCT02059642|"~     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of~     MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with~     ADHD.~   "
76224|NCT02059603|"~     Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao,~     Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after~     laparoscopic colorectal surgery within a traditional perioperative care setting. Recent~     evidence also suggested that a 'fast-track' perioperative program may help accelerate~     recovery after colorectal surgery. As electroacupuncture is simpler to implement and less~     labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior~     to fast-track program in reducing the duration of postoperative ileus and hospital stay~     after laparoscopic colorectal surgery.~      Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing~     the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.~      Design: Prospective, randomized, noninferiority trial.~      Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic~     resection of colonic and upper rectal cancer will be recruited.~      Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture~     with traditional perioperative care; or (B) fast-track program without acupuncture.~      Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of~     hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic~     requirement, morbidity, and medical costs.~      Conclusions: This study will determine if electroacupuncture is noninferior to fast-track~     program in reducing the duration of postoperative ileus and hospital stay after laparoscopic~     colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to~     laparoscopic colorectal surgery because it is simpler to implement and less labor intensive~     than fast-track program.~   "
76225|NCT02059590|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage~     product (BAL8728), in particular the routes of excretion and extent ot metabolism of the~     cleavage product following administration of a single intravenous dose of~     pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify~     the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single~     intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of~     BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of~     pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.~   "
76226|NCT02059577|"~     70 children and adults with autism spectrum disorders will be enrolled in a 1-year,~     single-blind treatment study. Assessments will be conducted at the beginning and end of the~     study, including measurements of nutritional, metabolic, and digestive status and~     assessments of autism severity and overall functioning. Half of the participants will be~     randomized into a treatment study, and half will be randomized to no changes in their~     current treatments. Treatments will be added in a sequential manner over 12 months,~     including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and~     healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and~     physicians will support and monitor the participants throughout the study.~      A group of 50 neurotypical children and adults, of similar age and gender, will be included~     for comparison.~   "
76227|NCT02059564|"~     A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label~     Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator~     on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus~   "
76228|NCT02059551|"~     Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an~     alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE)~     due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this~     study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of~     the legs in patients with suspicion of PE.~   "
76229|NCT02059538|"~     Supported by state-of-the-art systems medicine competences including integrative~     computational and functional genomics, the overarching goal of the trial is to investigate~     the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis~     of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective~     will be to translate the clinical and fundamental based discoveries into new diagnosis and~     preventive actions paving the way to novel modes of treatment in the successive stages of~     CMD progression.~   "
76230|NCT02059525|"~     This study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to~     study the proteomic, immunological, serological and clinical changes associated with pre-~     and post-treatment syphilis infection in a way that could ultimately lead to the development~     of a new ELISA and rapid diagnostic test of T. pallidum antigenaemia.~      The general aim of this prospecive observational cohort study is thus to quantify a set of~     target proteins with the highest diagnostic potential for the diagnosis of initial T.~     pallidum infection and T. pallidum persistence. A test which could directly detect the~     presence of T. pallidum antigens could represent a considerable advance over currently used~     tests in the diagnosis of initial syphilis infection, its response to therapy and in the~     diagnosis of syphilis reinfections. This prospective observational cohort study of~     HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the~     HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine,~     Antwerp.~   "
76231|NCT02059512|"~     The purpose of this study evaluate the effect of the method of administration of autologous~     bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass~     grafts in the surgical treatment of coronary heart disease, to assess the degree of~     effectiveness depending on the method of transplantation (intramyocardial, intracoronary).~   "
76232|NCT02059499|"~     This randomized phase III trial studies imiquimod or fluorouracil to see how well they work~     compared to observation in treating patients with high-grade anal squamous skin lesions who~     are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod,~     may stimulate the immune system in different ways and stop tumor cells from growing. Drugs~     used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether imiquimod or fluorouracil is more effective than observation in treating~     high-grade anal squamous skin lesions.~   "
76233|NCT02059486|"~     The purpose of this study is to evaluate the impact of the Teen Choice program on reducing~     the rates of unprotected sex of high risk youth in New York.~   "
76234|NCT02059473|"~     The purpose of this project is to compare operative repair of traumatically torn rotator~     cuff tendon with physiotherapy in a randomized prospective study.~   "
76235|NCT02059460|"~     To study the impact of intra and post-operative Terlipressin infusion on the occurrence of~     acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated~     Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels~   "
76408|NCT02057198|"~     The overall aim is to characterize and to compare the extent and quantity of C. difficile~     stool shedding, perianal colonization and environmental contamination in patients who~     received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective,~     randomized, microbiologic and molecular, study of environmental contamination from patients~     with proven C. difficile associated diarrhea (CDAD).~   "
76236|NCT02059447|"~     The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT)~     reduces the distressing impact of tinnitus to a significantly greater extent than a waiting~     list control or relaxation therapy.~      This study is a mixed design, with two groups assessed at a number of time points. The~     primary outcome measure will be that of tinnitus distress, and secondary outcomes will be~     taken of psychological distress and tinnitus loudness.~      The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait~     for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based~     Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2).~     All participants will be assessed at two main time-points (pre and post-treatment). The~     outcome measures will be repeated at 1 and 6 month follow-up points.~   "
76237|NCT02059434|"~     The purpose of this study is to assess the safety and tolerability of single doses of~     LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to~     severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of~     LAS190792 to produce bronchodilation (opening of the airways).~   "
76238|NCT02059421|"~     The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and~     Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in~     survivors of critical illness. Subjects will be recruited following discharge from the~     Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective~     measurements of sleep quality and duration at baseline and at 6 weeks. Objective~     measurements will be made by portable (home-based) sleep studies and will wear a watch that~     measures sleep. Subjective measurements will be performed by sleep questionnaires: PSQI,~     Epworth sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed~     at baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline~     and 6 weeks.~      The central purpose of this proposal is to perform a comparative-effectiveness study of a~     complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep~     disturbances in survivors of critical illness. The investigators hypothesize that, in~     survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in~     improving sleep quality (Pittsburgh Sleep Quality Index [PSQI] and sleep efficiency~     [measured by polysomnography]).~      A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic~     markers of inflammation and urinary biomarkers of sleep and stress. The investigators~     hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable~     to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and~     stress.~      A tertiary objective is to determine whether the presence of insomnia or other sleep~     characteristics is associated with hospital readmissions within 30-days.~   "
76239|NCT02059408|"~     The overall hypothesis of this trial is that screening for chronic kidney disease, followed~     by education or treatment program will improve blood pressure control among hypertensive~     non-diabetic persons.~   "
76240|NCT02059395|"~     Background:~      In cardiac arrest survival rates dramatically increase when bystanders are present and~     initiate Basic Life Support (BLS). However, even though serious efforts have been made,~     skill retention after a traditional time-based BLS course for laypeople remains suboptimal.~     In contrast, a mastery learning-based educational approach was shown to be efficacious and~     might be promising even for laypersons. Therefore the investigators aim to evaluate the~     impact of a mastery learning-based BLS course on skills retention of BLS in laypeople.~      Methods:~      Forty laypeople without previous BLS experiences will be randomized into the traditional~     time-based BLS course group (Control - TB group) or mastery learning-based group~     (Intervention - ML group).~      Both groups will receive BLS training consisting of 6 successive stations including~     diagnosis of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer~     BLS and AED use. In the ML group, subjects will deliberately practice and receive feedback~     at each station until a pre-set target level is reached. Subjects will be allowed to proceed~     to the next station only when they achieve the required target level of performance. In~     contrast, participants of the TB group will be taught the same 6 stations in two hours,~     according to standard American Heart Association BLS criteria. All subjects will have an~     assessment of knowledge and skills immediately after teaching (immediate post-test) and at~     four months (retention post-test).~      Implications:~      Previous research has shown that mastery learning-based education improves learners'~     procedural skill performance. The investigators study will determine the impact of a mastery~     learning-based BLS course on skill retention in laypeople.~   "
76241|NCT02059382|"~     The purpose of this study is to inform the integration of mobile and social media components~     into larger interventions aimed at increasing adherence and maintenance of physical~     activity. Nearly half of the US population do not meet physical activity recommendations of~     ≥150 minutes of moderate activity per week. The use of smartphones to self track data and~     upload that data to an online social network is becoming increasingly common and may be an~     effective way to motivate physical activity adherence and maintenance. We are proposing a~     two phase study to develop and evaluate a mobile health (mHealth) intervention that~     includes the use of two existing technologies: 1) the RunKeeper mobile app to collect and~     upload exercise data (distance, pace, time), and 2) the RunKeeper.com online social network~     as a place to analyze uploaded data and engage with a coach and online community. Phase 1~     (n=10) will iteratively develop the mHealth intervention and phase 2 (n=30) will pilot the~     mHealth intervention (participants will be randomized to either mHealth intervention (n=20)~     or control (n=10)) to collect feasibility, acceptability and preliminary efficacy data. All~     participants will attend a day-long ChiWalk/Run training to help them avoid potential~     injuries and meet their coach and community in-person. All participants will also be asked~     to wear a FitBit accelerometer from one week before the beginning of the intervention~     through one week after the end of the intervention to collect total physical activity data.~     This data will be uploaded automatically to the study data base. Primary outcomes will be~     total physical activity as collected by the FitBit accelerometer (and the RunKeeper mobile~     app for the intervention group) and secondary outcomes will be changes in psychological~     factors that may mediate adherence to physical activity.~   "
76242|NCT02059369|"~     While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for~     paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches~     are used for substrate modification: linear lesions, ablation of complex fractionated atrial~     electrograms (CFAE) or a combination of both. The aim of this study is to determine whether~     there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE~     ablation in combination or not with linear lesions in patients with persistent AF.~   "
76498|NCT02056028|"~     The definition of biliary fistula is heterogeneous and the more accepted is that proposed by~     the ISGLS. We devised a precise definition of post-resectional biliary fistula and a~     well-established policy both for its disclosure and management.Aim was the validation of our~     definition, and management of biliary fistula after hepatic resection in a large prospective~     cohort of patients and its comparison with that of the International Study Group of Liver~     Surgery (ISGLS).~   "
76243|NCT02059356|"~     The purpose and objective of this study is to determine the prevalence of elevated ammonia~     levels in subjects with cognitive impairment, and to observe if treating the cause of the~     elevated ammonia level improves mental status. This study does not include any imaging,~     treatment,or interventions, other than the blood draws. The blood draws will be taken to~     assess blood ammonia level and liver function. If the the ammonia level is not elevated, no~     further lab draws will occur. If the ammonia level is elevated, liver function is normal,~     and a cause for the high ammonia level is revealed with a plan for clinical treatment by the~     subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3~     months after treatment. The main risk to subjects is related to the blood draw (i.e.~     momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a~     potential loss of confidentiality. A paired student t test will be done with the two later~     blood to compare objective data.~   "
76244|NCT02059343|"~     Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary~     bypass for heart surgery. It is also often used after surgery and may be particularly~     helpful for children with heart disease. In order for this medication to be helpful and to~     minimize risks associated with taking the medication, it is important to provide correct~     dosing for this medication. Based on evidence from studies of other medications used during~     heart surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass~     is different from dosing in other settings. The purpose of this study is to evaluate how the~     heart-lung bypass machine affects dexmedetomidine levels in the body.~   "
76245|NCT02059330|"~     This study will investigate the dose-proportionality of palbociclib pharmacokinetics in~     healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will~     receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days~     between doses. Additionally, this study will investigate the effect of Japanese ethnicity of~     palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single~     dose-level between healthy subjects of Japanese descent and approximately fourteen healthy~     non-Asian subjects.~   "
76246|NCT02059317|"~     The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax,~     an indicator of local dynamic stability) of chronic low back pain patients versus that of~     healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low~     back pain patients).~   "
76247|NCT02059304|"~     The aim of this study is to examine the potential value of cervical length (CL) measurement~     with embryo transfer catheter in the prediction of spontaneous preterm deliveries in~     intracytoplasmic sperm injection (ICSI) cycles.~      Preterm birth is the leading cause of perinatal death and handicap in children. It is clear~     that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there~     is an estimated two-fold increased risk following ICSI.~      CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the~     prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that~     at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been~     shown that the measurement of CL on pregnancy is an effective method for identification of~     the group at high risk for PTD.~      In embryo transfer, catheter is placed the through cervical canal. The method we will use in~     this study, CL measurement with transfer catheter, will give more precise results than~     measurement with ultrasound.~      No study has been performed to evaluate the prediction of PTD by analyzing measurements of~     CL, preconceptionally. Our study will be the first in this topic.~      There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of~     prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related~     to the gestation at which treatment is initiated. If we know the risk of PTD before~     gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that~     also increase the relative risk of PTD, in ICSI pregnancies.~   "
76248|NCT02059291|"~     ThIS study is to determine whether canakinumab is able to induce and maintain a clinically~     meaningful reduction of disease activity in participants with HPF (Hereditary Periodic~     Fevers) compared to placebo.~   "
76249|NCT02059278|"~     This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both~     eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84~     days in patients with elevated eye pressure.~   "
76250|NCT02059265|"~     This phase II trial studies how well dasatinib works in treating patients with ovarian,~     fallopian tube, endometrial, or peritoneal cancer that has come back or is persistent.~     Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell~     growth.~   "
76251|NCT02059252|"~     SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin~     replacement. The scaffold consists of a porous matrix of cross-linked human fibrin plus~     alginate that has been designed and optimised to facilitate wound closure and healing~     through cellular ingress and rapid growth of new blood vessels.~      This proof of concept study will involve patients with surgical wounds resulting from the~     excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).~   "
76252|NCT02059239|"~     This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did~     not respond to treatment or has returned after responding to previous therapy, and who are~     in need of a stem cell transplant.~      The purpose of this study is to test the safety and effectiveness of giving the drug~     Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell~     transplant for lymphoma that has not achieved a complete response to salvage (treatment used~     for relapsed disease) chemotherapy.~   "
76262|NCT02059109|"~     The Belmont Rapid Infuser is a device currently approved to replace larger volumes of~     necessary fluids such as blood in a fast and safe manner. The purpose of the study is to~     evaluate proficiency and the retention of knowledge of how to use the device based on~     current methods of training compared to revised training methods.~      Hypotheses:~        1. The use of the traditional method of training is not effective, predicting less then~          half of staff will pass on the first attempt.~        2. Restructured test with hands-on training as opposed to oral presentation only with a~          written test will result in a pass rate of > 80%.~        3. Staff members who work in pairs will perform better than working alone when setting up~          the Belmont Rapid Infuser (BRI).~        4. Retention at 3 months will be higher with the restructured training method than with~          the traditional training method.~   "
76253|NCT02059226|"~     Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a~     disorder and serious enough to require treatment affects up to 10% of all youth by the age~     of 16. Anxiety disorders can have serious negative effects on a young person's personal~     relationships, school performance, and family life. These disorders may not be discovered by~     youth, parents and health care providers. Even if anxiety disorders are discovered, youth~     may not get the right therapy. Anxious youth can become sick if their anxiety is not treated~     properly.~      The investigative team will carry out research to test Breathe, their new Internet-based~     treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe~     includes information materials and personalized homework assignments to help anxious youth~     learn ways to manage anxiety.~      This study is a pilot randomized controlled trial (RCT) with two groups, an~     Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a~     resource webpage (control group; considered treatment as usual for youth waiting for~     services). The investigators will evaluate several methodological processes and outcomes~     through the following objectives:~        1. To evaluate the change in youths' anxiety (primary outcome) from pre- to post-~          intervention.~        2. To estimate recruitment and retention rates for a full-scale RCT.~        3. To estimate a sample size for a full-scale RCT.~        4. To define the minimal clinically important difference (MCID) for the primary outcome~          measure.~        5. To measure intervention acceptability.~        6. To determine the use of co-interventions during the trial.~        7. To conduct a preliminary economic analysis.~   "
76254|NCT02059213|"~     This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen~     Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive~     prostate cancer.~      The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen~     Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may~     significantly increase the efficacy of ADT.~   "
76255|NCT02059200|"~     Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for~     patients suffering from recurrent depression. Though a number of studies show that MBCT is~     effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent~     depressive patients, the chance of a new depression developing after end of treatment is~     still considerable. Ergo, there is room for improvement.~      Especially the development of a non-judging or compassionate attitude towards all experience~     seems to mediate the treatment effect. It is therefore our expectation that a follow-up~     intervention that focuses specifically on self-compassion could prove very useful in~     elaborating on the effects of MBCT.~      The research question of this research is therefore: what is the effect of compassion~     training in people suffering from recurrent depression who have already received MBCT~     training?~   "
76256|NCT02059187|"~     This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ participants~     with type 2 diabetes mellitus (T2DM).~   "
76257|NCT02059174|"~     The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of~     MK-1293 compared with a basal insulin (Lantus™) in participants with Type 1 Diabetes. The~     primary hypotheses are that the duration of action, pharmacodynamic profile, and~     pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.~   "
76258|NCT02059161|"~     The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in~     participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in~     hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293~     compared with participants treated with Lantus™.~   "
76259|NCT02059148|"~     Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days~     apart. One dose will be given with a standard meal, one dose with a high-fat meal and one~     dose without food. The study will evaluate the effects of the standard and high-fat meals on~     how much drug gets into the bloodstream. Side effects will be documented. This study is~     approximately 43 days, not including screening. Screening is required within 28 days prior~     to the start of the study.~   "
76260|NCT02059135|"~     The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of~     recombinant human antithrombin (ATryn) in addition to expectant management for the treatment~     of preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in~     extension of gestational age from the time of randomization into the study until delivery~     between ATryn and placebo treated subjects. In addition, the effect of ATryn on fetal and~     neonatal clinical outcomes will be assessed. The PK characteristics of ATryn in the subjects~     will be investigated by measuring AT activity levels in the mother during treatment and in~     cord blood.~   "
76261|NCT02059122|"~     This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus~     standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and~     internationally.~      The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early~     stages of Dengue infection in patients with clinical symptoms consistent with Dengue~     infection. This test is intended to be used on sera obtained within the first 7 days of~     symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing~     with a reference standard test.~      Subjects will be patients who present with symptoms consistent with dengue infection, such~     as fever and myalgia. After informed consent is obtained and the subject is screened for~     eligibility, 2 diagnostic samples will be collected. The first will be collected within the~     first 7 days of symptoms onset, and the second will be collected at least 7 days later,~     between the 10th and 21st days post-onset of symptoms.~      ELISA and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples~     from each method independently.~   "
76263|NCT02059096|"~     This study is designed to evaluate the effect of repetitive Transcranial Magnetic~     Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with~     Multiple Sclerosis suffering from chronic pain of neurological origin.~   "
76264|NCT02059083|"~     The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in~     adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary~     outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for~     cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome:~     number of days used cannabis in the past 30 days).~   "
76265|NCT02059070|"~     Background: Outpatient continuous interscalene brachial plexus blocks are used to control~     pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There~     have been no studies comparing the effects of these two formulations. The major concern is~     hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it~     may cause less blockade of the phrenic nerve. This study was to evaluate the effects of~     continuous interscalene brachial plexus infusions, with the hypothesis that respiratory~     function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on~     pain relief.~      Methods: All patients underwent baseline spirometry and ultrasound evaluation of~     diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then~     randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients~     returned to the hospital the following day for spirometry, ultrasound reevaluation, and~     evaluation of their pain level since discharge.~   "
76266|NCT02059057|"~     Crossover study for patients who were randomized to the Control Group in CLN0009.~   "
76267|NCT02059044|"~     One of the most common health care interventions in any healthcare setting is a medication~     prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with~     adverse drug events (ADEs). ADEs decrease patient health directly and can lead to~     non-adherence, which in turn has negative consequences.~      The investigators recently conducted a pilot project in which the feasibility and potential~     utility of an information technology enabled outreach program for monitoring patients~     receiving an outpatient prescription was tested. This intervention involved the use of an~     interactive voice response system programmed to automatically call ambulatory care patients~     following a prescription. If the system identified a potential medication problem, a~     pharmacist was notified who contacted the patient, modified the therapy accordingly, and~     informed a physician when necessary.~      The pilot project included 568 patients with diverse illnesses in two Canadian cities. High~     levels of patient and provider acceptability of the system were determined from 21 day~     interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary~     non-compliance events. Very few episodes of ameliorable ADEs were observed.~      The investigators feel these results justify a randomized control trial to assess the~     effectiveness of the intervention for improving patient centered outcomes. Ambulatory care~     patients receiving incident prescriptions for one of four conditions (hypertension, diabetes~     mellitus, depression, and anxiety) will be randomized to the intervention or routine care.~     The investigators expect that the system will reduce the severity and duration of outpatient~     ADEs and improve adherence to medication care.~   "
76268|NCT02059031|"~     This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data~     for selection of one of these tablet formulations for use in Phase 3. This is a~     single-center, randomized, two part, open-label, crossover study in healthy adult subjects.~     Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to~     assess the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative~     to the current GSK1265744 sodium salt formulation being used in the phase IIb studies under~     fasting conditions. Part A treatment periods will be separated by a 14 day washout. After~     completion of Part A, preliminary PK data will be analyzed and a decision will be made based~     on pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen~     subjects who will have participated in Part A will participate in Part B and receive the~     selected formulation with a moderate fat meal. All treatments will be administered as single~     30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during~     each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of~     study drug.~   "
76269|NCT02059018|"~     The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin~     affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied~     using the Dynamic Vessel Analyzer.~   "
76270|NCT02059005|"~     This study will assess Specialized Community Disease Management (SCDM), an intervention~     which employs various evidence-based strategies to engage substance using co-morbid patients~     while in the hospital and follow them into the community via an empirically validated~     telephone approach as well as contact with a trained community health worker peer~     specialist. The investigators will first adapt and refine the core SCDM intervention with~     patient, provider, and stakeholder input through an active community advisory board. The~     investigators will then conduct a three-year, randomized controlled trial of 222 patients~     enrolled prior to hospital discharge who are diagnosed with congestive heart failure,~     pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes~     mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be~     randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of~     nurse navigators and community health workers follow patients (primarily by telephone) for~     90 days post-discharge, but do not address the specific needs of SUDs. The investigators~     will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate~     larger reductions in substance use measured by urine-confirmed self-reported days using over~     the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to~     SCDM will attend more specialty substance abuse intervention and treatment sessions over the~     6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will~     demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over~     the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM~     will experience fewer days of rehospitalization and use of acute emergency services than~     patients randomized to TAU.~   "
76271|NCT02058992|"~     The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem)~     when used in the routine clinical setting in patients with sleep-onset difficulty associated~     with insomnia.~   "
76272|NCT02058979|"~     Abstract The administration of an antibiotic preoperatively is an important intervention~     that helps to reduce the risk of post-operative health-care associated infections (HCAI).~     These include urinary tract, surgical site and blood stream infection. Based on the current~     Surgical Infection Prevention Project, (SCIP) recommendations, the choice of the antibiotic~     is based on the nature and site of the surgery and the presence of a β-lactam allergy (Table~     1).~      Currently, the antibiotic treatment for preventing surgical infections is administered as a~     single bolus an hour before surgery, and every four hours after the initial dose. This~     presents a concentration profile that has a high concentration after the bolus, but decays~     as the kidneys remove the antibiotics. In this present study, investigators would like to~     compare this traditional method of delivery to a constant infusion model that would sustain~     a constant level of antibiotics that is defined by the difference between the rate of~     infusion and rate of clearance.~   "
76324|NCT02058303|"~     The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and~     a shorter-acting nerve block to a traditional single-shot nerve block in patients having~     hand, wrist or finger surgery.~   "
76273|NCT02058966|"~     Addiction to methamphetamine is a serious health problem. There are no medications that a~     doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a~     medication that could help people addicted to methamphetamine.~      This study will see how entacapone works in healthy people who are given methamphetamine. We~     think that the study drug will be well tolerated, and that it will prevent some of the~     effects of methamphetamine that make it so addictive. We also want to see how differences in~     people's genes may cause differences in the ways the study drug and methamphetamine work for~     them.~      The study has six total visits. The first visit is for screening. Tests and procedures will~     make sure it is safe for subjects to participate.~      The second visit is a familiarization day. Subjects will receive methamphetamine, but no~     entacapone. This is done to make sure they can tolerate the drug and recognize its effects~     before being given a second drug on the same day. Subjects will take surveys and computer~     tests to see how the medications change mood, thinking, and liking the drug.~      The final four visits are the actual study days. Subjects will be randomly assigned (like~     the flip of a coin) to the different ways to get either 1) study medication or placebo~     (placebo contains no active study medication) and then 2) methamphetamine or placebo.~     Subjects will be in all four groups during the study, which means that each day a subject~     will get a different group.~   "
76274|NCT02058953|"~     The purpose of this study is to collect and bank samples of blood and tissues (such as brain~     tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes~     and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples.~     The investigator hopes that by studying the biomarkers, he can develop tests in the future~     that can detect central nervous system (CNS) metastasis in blood samples before they show up~     on x-ray and develop medicines that can specifically target CNS metastasis.~   "
76275|NCT02058940|"~     The purpose of this study is to assess the feasibility of exenatide infusion for the~     treatment of high blood sugars following acute brain injury.~   "
76276|NCT02058927|"~     This is an observational study of HIV-1 infected children starting antiretroviral therapy to~     measure the magnitude and quality of general immune reconstitution and pathogen-specific~     immune reconstitution to measles virus.~   "
76277|NCT02058914|"~     We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages~     in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin~     clearance, triacylglycerol (TAG), and cholesterol concentrations.~   "
76278|NCT02058901|"~     The primary objective of this study is:~        -  To determine the maximum tolerated dose (MTD) of sunitinib when administered once~          weekly or once every two weeks.~        -  To assess the safety and tolerability of sunitinib in a once weekly or once every two~          weeks dose schedule.~   "
76279|NCT02058888|"~     The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming.~     Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can~     therefore contribute to the observed trend. Differences in the degree of selection pressure~     caused by various antimicrobials have not been systematically investigated until today. The~     aim of the proposed project is the determination of the impact of antibiotic treatment on~     the copy number of resistance genes in the human intestinal microbiome using metagenome~     shotgun sequencing. The resistance gene count in the gastrointestinal tract will be~     determined in a clinical cohorts of patients treated with either ciprofloxacin or~     cotrimoxazol as monotherapy. The subsequent quantification and comparison of the selection~     pressure facilitates the application of antibiotics with a lower potential to select for~     resistance. To achieve this goal, a self-controlled, prospective observational~     epidemiological study will be performed at two centres of the German Centre for Infection~     Research (Tübingen, Cologne).~   "
76280|NCT02058875|"~     The overall goal of this study is to improve cardiovascular outcomes in transplant~     recipients. The current standard immunosuppressive regimen in kidney transplant recipients~     depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than~     optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to~     investigate the effects of reversing this paradigm. More specifically, the effect of using~     maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or~     Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.~   "
76281|NCT02058862|"~     The purpose of this study is to determine if a home-based electrical stimulation (ES)~     program is more effective than the standard of care (SOC) at improving quadriceps function,~     functional outcomes, patient reported outcomes, and treatment compliance in patients~     recovering from knee surgery. It is hypothesized that there will be significantly better~     outcomes and compliance in ES group when compared to the SOC group.~   "
76282|NCT02058849|"~     The objective of the current proposal is to determine if concentrated beet root could~     improve medical treatment compliance as defined by completion of radiotherapy and 3 cycles~     of chemoradiation without dose reduction, preserve fat-free mass, and strength while~     reducing mucositis. The investigators central hypothesis is that dietary nitrate~     supplementation in head and neck cancer patients receiving aggressive medical care will~     improve compliance with medical treatment by attenuating the loss of muscle mass and~     strength and reducing symptoms (mucositis) associated with treatment compared to patients~     receiving standard care with placebo.~   "
76283|NCT02058836|"~     The purpose of this research study is to determine if Botox injections will provide relief~     from chronic testicular pain. In the study, the spermatic cord of particpants will be~     injected with either Botox or a placebo of saline. Botox is currently used to treat other~     urological conditions like overactive bladder and lower urinary tract problems. For these~     conditions, Botox works by relaxing muscles in the affected areas. The investigators believe~     that Botox will act similarly in the treatment chronic testicular pain.~   "
76325|NCT02058290|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospital costs.~   "
76326|NCT02058277|"~     This is an open label, randomized, single dose, one cohort, two sequence, two period~     crossover study in healthy subjects. The primary objective of the study is to evaluate the~     effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single~     oral dose of bosutinib in healthy subjects.~   "
76284|NCT02058823|"~     The purpose of this study is to compare cardiovascular physiological adaptation to~     intermittent hypoxia (IH) of nonobese healthy subjects. The exposure will be two periods of~     two weeks (IH versus exposure placebo hypoxia). The investigators will use pharmacological~     tools, peripheral vasodilator (amlodipine) or specific blocker of angiotensin receptor~     (valsartan) versus the taking of a placebo. The allocation of the tool and the exhibition~     will be randomized (HI / placebo, valsartan / amlodipine). The outcome measures evaluated~     concern the cardiovascular system, systemic inflammation and tissular and glucose~     metabolism.~      The investigators assume an increase in arterial resistance during the intermittent hypoxia~     compared to the control group, these being dependent on sympathetic tone.~      The investigators hypothesize that the metabolic alterations that will be observed after~     experimental simulation (IH and fragmentation of sleep for 15 consecutive nights) will be~     less severe in the valsartan group than in the amlodipine group in comparison with the~     placebo group.~      A serum bank and a gene bank will be performed for the requirements of subsequent studies if~     necessary.~   "
76285|NCT02058810|"~     The pilot study aims to compare the results of using a new respirator (OPTIFLOW~     TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of~     patients who have been hospitalized due to acute heart failure. We expect a faster and more~     effective stabilization after acute cardial decompensation among the patients with the~     High-Flow-machine.~      The study should show whether the use of High-Flow-Therapy leads to a relevant improvement~     in terms of objective clinical parameters of heart failure like those for cardial-renal~     syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior~     vena cava, in terms of the degree of shortness of breath and decompensation, and whether~     subjective clinical symptoms like dyspnea and quality of life differ between the two groups~     of patients.~      The investigators see the primary outcome of the study as the improvement of the~     cardial-renal syndrome as a sign of the more effective stabilisation compared to the~     standard therapy. Furthermore, the investigators expect a quicker decrease in serum~     creatinine and an improvement in the creatinine clearance through therapy with the~     High-Flow-Machine. In terms of secondary outcomes of the study, the investigators are~     interested in also comparing e.g., the duration of hospital stays, 90-day mortality, and~     rehospitalisation within three months. Here, the investigators expect a quicker improvement~     in the subjective shortness of breath of the patients who are treated using the~     Hifh-Flow-Machine. Moreover, we believe that along with the individual subjective~     improvements (quality of life survey), the patients will experience a quicker release from~     the hospital and in this way, lead to a healthcare economic improvement among patients with~     repeated hospitalizations who usually have chronic problems.~      It is also of great interest to us, whether the biomarker BNP is an appropriate parameter~     for determining the faster stabilization of the patient and whether the degree of~     improvement of subjective dyspnea is correlated with the time needed until the patient has~     been stabilised.~   "
76286|NCT02058797|"~     The purpose of this study is to determine the efficacy of Coherence Therapy in treating~     procrastination. For that, this intervention is compared to Cognitive-Behavioral Therapy~     which was already proved to be efficacious in treating this problem. The method used is a~     randomized controlled trial.~   "
76287|NCT02058784|"~     Open label study of Pracinostat will be tested to assess the effect of food on the~     single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted~     and fed conditions.~   "
76288|NCT02058771|"~     It is universally recognised that current methods for risk stratification of sudden cardiac~     death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index~     (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained~     from a standard 12 lead ECG acquired during an invasive electrophysiological study.~      In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified~     subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%)~     compared with those with an R2I2 <1.03 (11%) (P=0.004).~      This study will use non-invasive techniques to acquire electrical restitution data: exercise~     and pharmacological stress, and will incorporate body surface potential mapping to develop a~     non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a~     prospective, observational study.~      HYPOTHESES:~      PRIMARY:~        1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.~        2. The exercise stress protocol will create a dynamic range of heart rates that allows ECG~          quantification of electrical restitution heterogeneity that correlates with invasive~          R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a~          dynamic range of heart rates that allows ECG based quantification of electrical~          restitution heterogeneity that correlates with invasive R2I2 and is predictive of~          VA/SCD.~      SECONDARY:~        1. A high-resolution electrical map acquired using body surface potential mapping will~          correlate with R2I2 and these data can be included in the R2I2 calculation to improve~          its prediction of SCD/VA.~        2. Serial measurement of R2I2 will produce consistent values.~   "
76289|NCT02058758|"~     Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most~     accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very~     high sensitivity because the intravenous MR contrast agent highlights regions with increased~     vascularization and vascular permeability compared to normal breast tissues and benign~     lesions.~   "
76290|NCT02058745|"~     This is a study to evaluate the effectiveness of using an established intervention for~     depressive symptom management in conjunction with a needs-based caregiver intervention for~     improving the psychological and physical health of family caregivers of persons recently~     diagnosed with a Primary Malignant Brain Tumor.~   "
76291|NCT02058732|"~     Study the cervical spinal cord and brain over time to assess changes and differences in~     subjects with amyotrophic lateral sclerosis.~   "
76292|NCT02058719|"~     This study plans to learn more about pulmonary complications of human immunodeficiency~     virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy~     (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV~     infected patients, pulmonary complications (including chronic obstructive pulmonary disease~     (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue~     to be a major cause of morbidity and mortality in this population. The mechanisms underlying~     the increased risk of COPD and decreased lung function in HIV infected individuals is not~     well understand and needs to be studied.~      The investigators hypothesize that the immunoregulatory consequences and immunosuppressive~     lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung~     infection and injury in HIV infected smokers, hastening the development of COPD. The~     mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells~     from smokers and nonsmokers with and without HIV infection.~   "
76327|NCT02058264|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.~   "
80999|NCT01997216|"~     The purpose of this study was to compare binocular high contrast, high illumination (HC/HI)~     visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX®~     AQUA MULTIFOCAL contact lenses when worn for 9 hours.~   "
76293|NCT02058706|"~     This randomized phase II trial studies if enzalutamide added to standard luteinizing~     hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate~     cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies~     stop the body from producing or block the effect of male sex hormones (testosterone).~     Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of~     prostate cancer. Hormonal therapies that lower the level of testosterone are among the most~     effective treatments for prostate cancer that have spread to other areas of the body~     (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more~     effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.~   "
76294|NCT02058693|"~     In this Phase 4 trial we will study the safety, tolerability and efficacy of mixed salts~     amphetamine (MSA), trade name Adderall, augmentation of antidepressant therapy for Major~     Depressive Disorder (MDD) in depressed outpatient adults who are taking an antidepressant~     but have not had complete resolution of their symptoms.~      40 adult outpatients with MDD who failed at least one adequate trial of antidepressant~     monotherapy will be consented in a 63-day, cross-sequential, multicenter study comprising~     two treatment phases of 21 days each. The time frame from consent to baseline is 7 days.~     Patients will receive placebo or MSA in Phase 1, and in Phase 2, participants will receive~     MSA. There will also be a two-week follow up visit after the completion of Phase 2.~      We hypothesize that MSA will be safe and well tolerated, and will improve the patient's~     response to their antidepressant and provide superior symptom relief to antidepressant~     alone. The primary outcome measure is the Massachusetts General Hospital Cognitive-Physical~     Function Questionnaire (MGH-CPFQ).~   "
76295|NCT02058680|"~     This study is investigating the safety and efficacy of a vaccine directed against prostate~     tumor cells. The researchers are interested in evaluating the safety and tolerability of the~     vaccine, and the effects of the vaccine on survivability, time to measurable disease,~     prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.~      Eligible patients include those with recurrent prostate cancer as shown by elevated levels~     of PSA, although there is no evidence of tumors that are measurable by imaging studies. In~     addition, to be eligible patients must have prostate cancer that either has not been treated~     by hormonal therapy or is not responsive to hormonal therapy.~   "
76296|NCT02058667|"~     The purpose of this trial in addition to a dose finding study for concurrent Paclitaxel,~     will be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of~     at least 5cm will be used on the protocol and extending it to 7cm. Considering the standard~     treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional~     50.4 Gy followed by a boost should target a total dose of 120 Gy.~   "
76297|NCT02058654|"~     This study will examine the impact of creatine supplementation on muscle function and~     cognitive performance in young and older subjects.~   "
76298|NCT02058641|"~     This will be an exploratory, open-label, single sequence, two part study (Part A and an~     optional Part B). The aim of this study will be to assess whether systemic inhibition of~     Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once~     daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib,~     will specifically reduce the number of macrophages and/or result in a higher proportion of~     M2 macrophages in skin blisters induced by cantharidin (a chemical agent that causes~     blisters). In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will~     be recruited. In Part B of the study, a cohort of 8 additional healthy subjects with~     matching age (+/- 24 months) and gender to Part A may be recruited.~   "
76299|NCT02058628|"~     This is a randomized, comparator-controlled, single-blind, parallel-group study. The current~     study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide~     (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of~     facial acne vulgaris. The results of the study will enable a better assessment of the safety~     and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well~     established treatment. Based on the data more evidence based recommendations will be~     possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects~     will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of~     the study will be over 12 weeks.~   "
76300|NCT02058615|"~     Male partners of women with breast cancer experience distress, so we want to develop a way~     to support them so they, in turn, can care for their wives. The purpose is to pilot test an~     online male spouse transition toolkit (MaTT) that the research team has developed. The~     specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and~     feasibility, and; b) collect preliminary data to determine potential effectiveness of the~     Toolkit in increasing hope, general self-efficacy and quality of life, and its potential~     effectiveness in decreasing guilt scores for male partners of women with breast cancer~     (stages 1-3).~   "
76301|NCT02058602|"~     This is a clinical study to characterise the lung function, airway morphometry,~     pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary~     Fibrosis (IPF) over a period of up to 6 months. Inhalation profiles will be recorded from~     patients with IPF as they inhale during tidal breathing, and following two sets of~     instructions (maximal effort and 'long, steady and deep' inhalation), across a range of~     airflow resistances that reflect those of typical inhalers used to deliver medication to the~     lungs. Mouth and throat dimensions will be measured using an acoustic reflectance~     Pharyngometer. Measurements of lung function will be made using conventional sprirometry,~     plethysmography and diffusion, whilst Low Dose High Resolution Computed Tomography (HRCT)~     will be used to scan the airways at two lung volumes; functional residual capacity (FRC) and~     total lung capacity (TLC). Data from HRCT will be used to reconstruct airway morphometry,~     and model inhaled particle deposition within the lung. Overall, the study allows a further~     understanding of the IPF patient population, using the data to assist in the development of~     new inhaled products for this disease. Following up the patients with additional HRCT scans~     at 3 and 6 months will enable the sensitivity of CT based criteria of disease progression to~     be compared with lung function criteria. No investigational product will be used in this~     study.~   "
76302|NCT02058589|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or~     older who are receiving chronic immunosuppressive therapy.~   "
76303|NCT02058576|"~     The purpose of this study is to assess the bioequivalence of the second generation~     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently~     available commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4~     mg capsule in healthy adult male subjects. Subjects in this study will receive either a~     single oral dose of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg~     combination capsule or a single dose of commercially available combination of dutasteride~     0.5 mg and tamsulosin HCL 0.4 mg capsule followed by a 28-day washout period both in fed~     state. The study will enroll approximately 92 healthy adult male subjects in order to~     complete approximately 76 evaluable subjects. The total duration of a subject's involvement~     in this study is anticipated to be approximately 12 weeks.~   "
76304|NCT02058563|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent~     MMR (Priorix®), comparing it to Mercks MMR vaccine (M-M-R®II), which is approved for use in~     the US.~   "
76305|NCT02058550|"~     This randomized, pilot phase I trial studies whether phone or email reminders increases~     vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they~     undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive~     material placed directly into or near a tumor to kill tumor cells. A reminder program may~     help increase use of vaginal dilators and decrease long-term side effects following~     brachytherapy.~   "
76306|NCT02058537|"~     The primary goals of this study are to ease the symptoms of patients with Eosinophilic~     Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those~     symptoms.~   "
76307|NCT02058524|"~     The investigators are conducting an open-label study of fecal microbiota transplantation~     (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot~     study the investigators will evaluate the feasibility, safety, and tolerability of a single~     application of FMT delivered colonoscopically. The investigators will also characterize the~     impact of FMT on the microbiota of the recipient and determine if it correlates with the~     microbiota from the FMT donor.~   "
76308|NCT02058511|"~     The study comprises of a series of pupillary measurements using infrared pupillometry in~     patients undergoing arthroscopic knee surgery of any type.~      Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary~     reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is.~     This may help to predict the amount of discomfort a patient will be experiencing after~     emergence from general anesthesia.~      In addition to measuring the pupillary reflex dilation, we will also measure oscillations of~     pupil size before and after indiction of anesthesia, as well as during recovery. These~     spontaneously occuring oscillations in pupil size, also called hippus, appear to be~     sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not~     been systematically addressed.~      The aim of the study is~        1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve~          blocks will block the PRD. This would allow assessment of block success in the~          anesthetized patient.~        2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized~          patient during and at the end of surgery with early postoperative pain scores and~          subsequent analgesia requirements. Such correlation would allow to predict the amount~          of postoperative pain before the patients emerge from general anesthesia.~   "
76309|NCT02058498|"~     Will adult liver transplant patients who are provided with physical activity (walking)~     instructions increase their physical activity and perceive an improved quality of life?~   "
76310|NCT02058485|"~     Hypertensive patients' often severe hypotensive response after induction of anesthesia and~     excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical~     incision and extubation. There are many publications in the literature of preoperative~     evaluation of patients with hypertension and perioperative treatment of hypertension but is~     not sufficient about anesthetic management of these patients. Purpose of our study, was to~     investigate the haemodynamic effects of dexmedetomidine and midazolam used for premedication~     in hypertensive patients relative to each other and according to the normotensive patients.~   "
76311|NCT02058472|"~     Study Design : randomized, open label, single-dose, 2-way cross-over design~      Phase : Phase I~   "
76312|NCT02058459|"~     The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in~     patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a~     similar safety profile and improved physiological and functional outcomes to a sham-control.~   "
76313|NCT02058446|"~     The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in~     worldwide populations including Asian patients. The study primarily aims to evaluate the~     effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in~     Taiwan using a prospective, open-label, non-randomized approach.~      The study also wants to investigate the safety of Amlodipine/Valsartan combination during~     the 6-week treatment period.~   "
76314|NCT02058433|"~     Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st~     regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing~     cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the~     ability of an individual to metabolize or excrete cytotoxic drugs, because it is not related~     to liver function and is poorly correlated with glomerular filtration rate, and does not~     seem to be a determinant of toxicity. Pharmacokinetic parameters such as area under the~     curve have been shown to correlate with toxicity. The advantages of using a fixed dose of~     antineoplastic agents for all of the patients are obvious. Pharmacokinetically guided~     treatment would avoid severe adverse effects, which has not been sufficiently investigated~     in advanced NSCLC.First, the investigators monitor the blood concentrations of paclitaxel~     and neutropenia blood toxicity after chemotherapy with paclitaxel and carboplatin in~     patients of NSCLC and verify suitable paclitaxel therapeutic window for Chinese patients.~     Then the investigators compare safety and efficacy between individual paclitaxel dose~     adjustment based on the therapeutic window compared with conventional dosage.~   "
76339|NCT02058108|"~     The purpose of the study is to assess the efficacy and safety of telbivudine at a dose of 20~     mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative~     CHB patients aged 2 to <18 years with the indication of antiviral CHB treatment. This study~     is part of the commitments of the pediatric development plan for telbivudine in Europe and~     US.~   "
76315|NCT02058420|"~     Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased~     chance for bone fractures. Women are 4 times more likely to have osteoporosis than men~     because there is no estrogen protection after menopause and women in general have lighter~     and thinner bones. Recent studies have indicated tocotrienols (one kind of vitamin E)~     supplement may be good for the bone health in postmenopausal women. However, no study has~     ever been done the role of tocotrienols in bone health in postmenopausal women. Our~     long-term goal is to develop a new strategy featuring a dietary supplement (i.e.,~     tocotrienols) for slowing down bone loss in postmenopausal women. The purpose of the study~     is to examine the effect of 12-week tocotrienols on bone measurements in postmenopausal~     women. Investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail~     system, campus announcement, local radio, newspapers, and TV scripts. We plan to enroll~     approximately 200 women to obtain 78 qualified women at the start of the study. After~     screening, qualified participants will be matched by body weight and age, and then randomly~     assigned to no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome~     measures will be assessed at baseline, after 6, and after 12 weeks. Bone-related~     measurements will be recorded using blood and urine samples. Investigators will monitor~     safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality~     of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.~   "
76316|NCT02058407|"~     This study is the first administration of GSK2793660 to humans and will evaluate the safety,~     tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral~     doses of GSK2793660 in healthy subjects. The study will comprise two parts (Part A and Part~     B). Part A will consist of two cohorts of subjects, each taking part in a three-way cross~     over study, with ascending doses of GSK2793660 and placebo. Available safety, PK and PD data~     will be reviewed before each dose escalation. This will be followed by a food-effect arm in~     the cohort that received what is deemed to be the target clinical dose. Part B is planned to~     consist of up to two cohorts of subjects, each taking part in one 14 day repeat dose study~     period. Subjects will be dosed on Day 1 and then on Days 3-15. It is planned that two doses~     will be evaluated. The dose(s) to be tested will be selected based on safety, PK, and PD~     from Part A. The study is intended to provide sufficient confidence in the safety profile of~     the molecule and information on target engagement to allow progression to further studies.~   "
76317|NCT02058394|"~     The purpose of this study is to investigate postoperative events in patients noted to have~     retained nuclear fragments in the anterior vitreous during routine phacoemulsification and~     in those who did not.~   "
76318|NCT02058381|"~     Based on the evidence acquired in the post-menopausal setting with everolimus and on~     pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib~     and buparlisib, in combination with endocrine therapy in hormone receptor-positive MBC, the~     purpose of this phase Ib trial is to assess the maximum tolerated dose (MTD) and/or the~     RP2D(s), to characterize the safety and tolerability, to determine the single and multiple~     dose PK profile and assess the preliminary anti-tumor activity of alpelisib and buparlisib~     in combination with tamoxifen plus goserelin acetate in premenopausal hormone~     receptor-positive advanced breast cancer patientsgroup.~   "
76319|NCT02058368|"~     This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The~     aim of the study is to investigate whether combination therapy with dutasteride and~     tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and~     health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical~     progression including older men (>=50 years), with moderate-severe symptoms of BPH, enlarged~     prostates (>=30 cubicentimeter [cc]) and prostate specific antigen (PSA) >= 1.5 nanograms~     per milliliter (ng/mL). Each subject who met the eligibility criteria at screening will~     enter a four-week single-blind, placebo run-in period following which each subject will be~     randomised into a 2 year double-blind treatment phase. The total study duration for each~     subject will be up to 110 weeks.~   "
76320|NCT02058355|"~     This project aims to develop and evaluate the effectiveness of an Personalized Normative~     Feedback (PNF) intervention via the internet, through a randomized clinical trial for~     alcohol consumption among Brazilian college students, as well as evaluating the most~     effective components of the PNF (normative and list of consequences). The sample is composed~     of college students aged between 18 and 30 years. Participants allocated into four different~     groups: control, full intervention (PNF), feedback with normative components (FN) and~     feedback with list of consequences (FLC). The investigators will use the dismantling design~     to study the most effective components. Participants will be followed-up at 1, 3 and 6~     months.~   "
76321|NCT02058342|"~     Compared to other children, those with disability have additional challenges to being~     physically active. Prader-Willi Syndrome (PWS) is a genetic form of childhood obesity that~     is characterized by hypotonia, growth hormone deficiency, behavioral, and cognitive~     disability. In children, the low prevalence of PWS (1 in 10,000 to 15,000 live births) makes~     group-based physical activity (PA) interventions impossible. In contrast, the home~     environment presents a natural venue to establish a PA routine for this population. The~     present high prevalence of non-syndromal childhood obesity (one in four) and high physical~     inactivity rates, make alternative approaches to increasing PA in this population an area of~     high interest. Therefore, we have developed a 24-week home-based physical activity that~     could be suitable for children and adolescents ages 8-15 with PWS as well as obese children~     without PWS ages 8-11 years. It is hypothesized that: 1) an age-appropriate 24-week~     home-based PA intervention will increase PA levels in youth with PWS and without the~     syndrome but with obesity; 2) motor proficiency, central sensory reception and integration,~     and body composition will significantly improve in youth with and without PWS following~     completion of the home-based PA intervention and 3) physical activity self-efficacy and~     quality of life will increase significantly in youth with and without PWS who complete the~     home-based PA intervention. The study participants are 115 youth ages 8-15 y (45 with PWS~     and 70 without PWS but categorized as obese). The study utilizes a parallel design with the~     wait-listed control group receiving the intervention after serving as control. Participants~     are expected to complete the PA curriculum 4 days a week for six months including playground~     games 2 days a week and interactive console games 2 days a week. Parents are trained at~     baseline and then provided with a PA curriculum (Active Play at Home) and equipment to guide~     their implementation of the program at home. Measurements of children and parent dyads are~     assessed at baseline and at the end (week 24) of the intervention or control periods.~     Outcome measures include PA, body composition, motor proficiency, central sensory reception~     and integration (subsample of children only), quality of life and physical activity~     self-efficacy. PA intervention compliance is monitored using mail-in daily self-report~     checklists.~   "
76322|NCT02058329|"~     The overall goal of the project is to reduce the incidence of post hip fracture morbidity~     and mortality by conducting geriatric fellow periodic home visits.The assessment will be~     multidisciplinary and will include assessments of functional status, depression,~     environmental risks and medical conditions. This group will be compared against a group~     followed by the usual standard of care post hip fracture.~   "
76323|NCT02058316|"~     Background Invasive pulmonary aspergillosis (IPA) remains an important cause of morbidity~     and mortality among patients with hemato-oncological malignancies. Due to the crude~     mortality of >90% in absence of adequate treatment, timely diagnosis and early start of~     antifungal therapy are key factors in the successful treatment of IPA. Various studies have~     shown that early initiation of antifungal therapy may improve IPA survival to above 70%.~     Diagnosis of IPA, however, remains difficult as clinical signs and symptoms as well as~     radiological findings are often unspecific and conventional culture methods lack~     sensitivity. In recent years antigen testing has therefore become one of the cornerstones of~     IPA diagnostics. Brochoalveolar lavage (BAL) Galactomannan (GM) testing is currently the~     most promising approach for early detection of pulmonary infections by this fungus. However,~     limitations of GM detection are assay turn-around time, which varies widely between centers~     (less than a day to several days), and the need for appropriately equipped laboratories that~     routinely test for this antigen. These limitations are overcome by the Aspergillus~     Lateral-Flow Device (LFD), a novel point-of-care (POC) test for IPA diagnosis developed by~     Dr Thornton at the University of Exeter, UK. This simple, rapid (15 min), single-use test~     can be performed in rudimentary facilities using BAL specimens. In a retrospective single~     centre study we have recently evaluated the LFD test in 39 BAL samples from hematologic~     malignancy patients and solid organ transplant recipients. Sensitivities and specificities~     of BAL LFD tests for probable IPA were 100% and 81%, respectively. Galactomannan levels in~     cases with negative LFD were significantly lower than in patients with positive LFD (P~     <0.0001). We concluded that the LFD test of BAL specimens is performed easily and provides~     accurate and rapidly available results. Therefore, this new point-of-care test may be a very~     promising diagnostic approach for detecting IPA in BAL specimens from haematological~     malignancy and SOT patients. For routine clinical use, however, multicenter studies with~     larger sample sizes also from other patient collectives are necessary. In this multicenter~     study we will evaluate the LFD test in BAL samples.~      Study Objectives Primary Objectives To evaluate the Lateral Flow Device test, a rapid (15~     min), point-of-care test for IPA diagnosis using bronchoalveolar lavage (BAL) fluids from~     patients at risk for IPA.~      Secondary Objective To evaluate the potential of BAL Lateral Flow Device test for prognosis~     in patients with IPA.~      Study Design This is a prospective multi-center study conducted in three centers in Austria~     (Graz, Vienna and Innsbruck) and one centre in Germany (Mannheim). In order to meet the~     objectives an estimated number of 300 BAL samples from patients at risk for IPA (50 to 100~     per centre) will be included in the study cohort. The Lateral Flow Device test will be~     performed prospectively in BAL samples from the patients and results will be compared to GM~     results, PCR findings, clinical/radiological findings as well as conventional culture~     results. In addition, retrospective testing of BAL samples that were previously routinely~     tested for GM will be performed in up to three participating centers (Graz, Innsbruck and~     Mannheim) to ensure to reach the proposed number of 300 BAL samples. The treating clinicians~     will not be informed about BAL Lateral Flow Device test results and the test will therefore~     have no impact on patient management / treatment decisions.~   "
76328|NCT02058251|"~     In comparison to the general population, military personnel and veterans are at increased~     risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder~     (PTSD). Despite promising developments in the past decade, the treatment of patients with~     SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al.,~     2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term~     negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation~     (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or~     systemic OT administration decreases activation of the amygdala in response to visual~     fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful~     events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville~     and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However,~     little attention has been focused on whether OT decreases SUD vulnerability after exposure~     to traumatic stress in preclinical or clinical studies. This clinical project will determine~     whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and~     decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier~     Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.~   "
76329|NCT02058238|"~     To quantify potential short- and long-term benefits of robotically-guided minimally invasive~     (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal~     instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a~     matching cohort of control patients, performed using a freehand technique, both in MIS and~     open approaches.~   "
76330|NCT02058225|"~     The purpose is to study the effect of infant nutrition on brain development, as measured~     using Magnetic Resonance (MR) techniques. The investigators will collect detailed~     information about the diet of each of the infants, and seek to correlate this information~     with multiple MR measurements, including structural imaging, diffusion imaging, and~     functional connectivity. The MR scans will be performed at birth and 3 months of age.~     Dietary information collected will include detailed food diaries describing the feeding~     habits of the infants, and food frequency questionnaires to characterize the diet of the~     mother.~   "
76331|NCT02058212|"~     ROS plays an essential role in the pathogenesis of many reproductive processes. High~     follicular fluid ROS levels are associated with negative IVF outcomes.~      is plasma level of reactive oxygen species is affected by antioxidant treatment in~     endometriotic women?~   "
76332|NCT02058199|"~     The investigators are attempting to compare the anticoagulant (blood thinning) effects of a~     recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass~     surgery to people who have not had this surgery. It is thought that gastric bypass may alter~     the absorption of this medication, but this has not been previously studied.~      The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers~     who are in one of four groups~        1. Non obese people who have not had a gastric bypass.~        2. Obese people who have not had a gastric bypass~        3. People who have had a gastric bypass~        4. People who are planning to undergo gastric bypass surgery in the near future who are~          willing to be studied before and after the bypass.~      The study will involve taking a single low dose of rivaroxaban and multiple blood samples~     will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be~     measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban~     will be compared between the different groups.~   "
76333|NCT02058186|"~     Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic~     dermatitis patients (AD) resulted from the reduction of cathelicidin production in these~     patients plays the important role in pathogenesis of this disease. Recently in vivo study~     has showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin~     D might be beneficial in atopic dermatitis.~      Objective: To determine the effect of oral vitamin D supplement on clinical impact including~     skin colonization of S. aureus in atopic dermatitis patients.~   "
76334|NCT02058173|"~     The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo~     for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients~     with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150~     mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have~     receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to~     study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are~     pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of~     therapy (12 weeks) and at baseline, first, second and third month after receiving drug and~     placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared~     between groups.~   "
76335|NCT02058160|"~     Primary Objective:~      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination~     (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.~      Secondary Objective:~      To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin~     glargine (with or without metformin) over a 30 week treatment period in participants with~     type 2 diabetes.~   "
76336|NCT02058147|"~     Primary Objective:~      To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone~     and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c)~     change from baseline to Week 30.~      Secondary Objective:~      To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio~     combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin~     treatment) over a 30 week treatment period in participants with type 2 diabetes.~   "
76337|NCT02058134|"~     The purpose of this study is to determine whether intra- and postoperative use of the~     cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in~     patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively~     have an increased risk for bleeding.~   "
76338|NCT02058121|"~     The purpose of this study is to test if an ACT group intervention focusing on body image~     enhances recovery and reduces relapse in patients treated at a specialised eating disorder~     unit.~   "
76340|NCT02058095|"~     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo~     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral~     response to acute sodium loading in subjects with preclinical Diastolic dysfunction (PDD)~     and renal (kidney) dysfunction~   "
76342|NCT02058069|"~     The Investigation will be conducted as a single-submission, multi-center study with approval~     from and in compliance of the Western Institutional Review Board (WIRB).~      The overall objective of this Investigation is to assess the safety and effectiveness of the~     Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application.~     Specifically, the study objectives are classified as follows:~        -  Primary Objective: Surgeon assessment of standardized TKA complications both~          intra-operatively and at short term follow up.~        -  Secondary Objective: Radiographic assessment of post-operative limb alignment.~        -  Supporting Objective: Patient assessment of post-operative function and satisfaction.~   "
76343|NCT02058056|"~     The main objective of this trial is to assess NCF after early HA-PCI concomitant to the~     second cycle of CHT and to tRT for patients with LD SCLC.~   "
76344|NCT02058043|"~     DESCRIPTION OF RELATED QUESTION Cognitive disorders are frequently encountered and present a~     major public health problem given the aging of the population.~      There is not one, but several neurodegenerative pathologies individual differentiated.~      Particularly distinguished is Alzheimer's disease (the most common), dementia lobar~     fronto-temporal associated with semantic dementia (a disease with a particular tropism for~     semantic memory and the anterior temporal lobe), and dementia with Lewy bodies.~      To differentiate these pathologies is, for the clinician, is a major issue and the clinic~     may not be enough.~      The management and current diagnostics of atypical cognitive disorders, that is to say,~     patients with clinical symptoms or neuropsychological testing results suggestive of a~     neurodegenerative disorder other than Alzheimer's disease, are based largely on data~     imaging.~      In the first intention, conducting imaging by MRI is recommended by the HAS, particularly to~     search for treatable causes to these cognitive disorders (tumors, intracranial hemorrhage in~     particular) but also to study the distribution of cerebral atrophy.~      The sequences used are the sequences 3D T1, axial Flair, gradient echo axial T2 and coronal~     T2 in the plane of hippocampi and also diffusion imaging.~      Research has shown interest in the study of cerebral perfusion in cognitive disorders.~      The HAS recommends not to inject contrast medium on MRI in this context. The sequence of~     perfusion by tagging arterial protons or arterial spin labeling (ASL) does not use~     exogenous contrast medium. This is available as a commercial product, CE marked, on most of~     the recent clinical MRI scanners. This non-invasive technique, requiring no special~     precautions (e.g. verification of renal function) is used in routine clinical practice at~     the University Hospital of Rennes and in many centers. In the imaging of patients with~     dementia, it is widely used as well as the 3D T1 sequences or diffusion imaging~     (International Initiative ADNI) and is subject to optimization and harmonization of use in~     routine clinical practice with the European COST AID actions.~      The second intention, an isotope imaging by FDG-PET or study of perfusion SPECT can also be~     performed. The interest of isotopic imaging (FDG-PET and SPECT) lies in the provision of~     information metabolic nonexistent in MRI, with a superiority of FDG-PET compared with SPECT.~     FDG-PET is the preferred examination and is carried out at CRLCC Eugène Marquis de Rennes in~     this context.~      The aim of our study is to compare the imaging of TEPFDG, a technique not morphological, and~     ASL that, even if they do not study the same mode (metabolism for the first and perfusion~     for the second) may depict consistent anomalies.~   "
76345|NCT02058030|"~     Background - The purpose of the present study is to evaluate the success and pharyngeal~     trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway~     insertion~      Methods~      - This prospective randomized, controlled study included 80 adult patients . In the 3 cm~     (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6~     cm height of pillow. The success rate at first and second attempt, insertion time, blood~     staining on cuff, sore throat and hoarseness were assessed.~   "
76346|NCT02058017|"~     This is a lead-in dose escalation study to determine the safety, tolerability,~     pharmacokinetics, maximum tolerated dose (MTD), and recommended Phase II dose of OPB-51602~     administered on a weekly basis in subjects with advanced malignancies. Using the recommended~     phase II dose, the efficacy and tolerability of OPB-51602 administered prior to definitive~     chemoradiotherapy will be evaluated in locally advanced NPC patients. This study's~     overarching goal is the development of STAT3 inhibitors as a novel class of anti-cancer~     agents and the optimization of patient selection for STAT3 inhibitor therapy through~     parallel biomarker studies. This study hopes to establish a therapeutic window for OPB-51602~     in solid tumours and will evaluate its potential as a targeted therapy of NPC, since this~     represents a critical unmet clinical need. The development of predictive and pharmacodynamic~     biomarkers in tandem with the clinical evaluation of OPB-51602 will be crucial to its~     therapeutic advancement and will enable an understanding of the genetic contexts of~     responsiveness and resistance to OPB-51602, which can in turn lead to the development of~     effective drug combinations to overcome resistance.The study hypothesizes that OPB-51602, a~     first-in-class STAT3 inhibitor, is efficacious in solid tumours with constitutively~     activated STAT3, such as NPC.~   "
76347|NCT02058004|"~     In modern anesthesia practice, the application of cricoid pressure during intubation is not~     infrequently used with the goal of preventing gastric-to-pulmonary aspiration. The evidence~     to support this practice is very scarce, and there have recently been many reports in the~     literature questioning the safety of cricoid pressure during intubation. Therefore, the goal~     of this study will be to randomize those at risk for microaspiration to receive cricoid~     pressure versus no cricoid pressure during intubation. We will specifically exclude those~     patients thought to be at the highest risk of aspiration (it is considered standard of care~     to perform cricoid pressure during intubation of this population). We will include those~     patients with some risk factors for aspiration (it is not considered standard of care to~     apply cricoid pressure during intubation of this population).~   "
76348|NCT02057991|"~     This randomized pilot trial studies mindfulness-based program in educating patients with~     colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce~     stress and fatigue in patients with colorectal cancer and their caregivers.~   "
76349|NCT02057978|"~     The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES~     compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.~   "
76350|NCT02057965|"~     This study will test the hypothesis that MSCs in combination with Everolimus facilitate~     Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic~     infections compared to standard tacrolimus dose.~   "
76418|NCT02057068|"~     This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a~     topic that has important implications for the safety, health, functioning and quality of~     life of older Veterans living at home and being cared for by a family caregiver (CG). The~     purpose of the first phase of this study is determine the relationship between CG and care~     recipient (CR) sleep and describe the impact of dyadic sleep to daytime functioning and~     well-being for Veterans and their caregivers. The information from phase 1 will inform the~     next study phase in which the investigators develop and field test non-pharmacological,~     technology based, sleep hygiene, exercise and meditation interventions to improve sleep in~     Veteran caregiving dyads.~   "
81200|NCT01994590|"~     The goal of this clinical research study is to learn if adding dovitinib to the combination~     of abiraterone acetate and prednisone may help to control metastatic CRPC. The safety of~     this drug combination will also be studied.~   "
76351|NCT02057952|"~     The main objective for this project is to identify effective methods of treating obesity in~     at-risk populations. The investigators will be comparing weight loss from usual care, in~     person, and video conference weight loss programs. The investigators will follow 210~     participants for 12 months to see if they lose and maintain 2kg of weight. The investigators~     will also compare the costs of video conference versus in person administered programs.~      Potentially eligible participants will be identified based on data in the Regenstrief~     Medical Records System or by referral from the Wishard HealthyMe weight loss program staff~     or a Wishard Community Health Center (CHC) primary care provider. The PBRN staff will~     carry-out initial recruitment. Following consent, a baseline assessment will be performed~     and each participant will be randomized into one of three groups: usual care control, in~     person weight loss or online video conference weight loss. At 6 and 12 months a follow up~     assessment will be performed and compared to measures from the investigators baseline~     assessment. Total costs for each program will be compared as well.~      The weight loss interventions involve group meetings two times per week where education,~     exercise, and social support are provided. Participants will also receive a detailed~     education booklet. Those randomized to the in-person group will meet in the CHC and those in~     the video-conference group will meet online in a multi-party video-conference. All~     participants will receive usual CHC care.~   "
76352|NCT02057939|"~     The purpose of this study is to describe the 2 year progression-free survival in men with~     recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard~     androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have~     recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in~     the absence of metastatic disease on CT and bone scans. In addition to standard ADT and~     radiation therapy, research participants will take enzalutamide once daily for six months.~     It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy~     compared to the historical control data in a similar patients setting.~   "
76353|NCT02057926|"~     The main objective of this study was to evaluate the histological impact of treatment with~     tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge~     preservation technique (RPT). Additionally, secondary objectives were to evaluate the effect~     of TTC on bacterial colonization and inflammatory response. This is a randomized~     simple-blind clinical trial. Consecutive patients referred to the Department of~     Periodontology at Universitat Internacional de Catalunya (Barcelona, Spain), between~     November 2009 and April 2011, were included in the study. This study was based on data~     collected from 20 surgical sites in 10 systemically healthy patients requiring 2 extractions~     with SPT. Before starting the surgery, the two teeth of each selected patient were~     randomized in two groups. The test group underwent RPT with CMs embedded with TTC solution~     (CMs TTC), and the control group was performed without TTC solution (CMs NO TTC).~     Randomization was performed using SPSS software (version 18, SPSS Inc., Chicago, IL, USA).~     In the test group, both membranes were first dipped for 5 minutes in TTC solution (50~     mg/ml). This involved the use of 250 mg tablets of TTC and 5 ml of saline that were mixed in~     a sterile trough. A sample of the membrane used in each SPT was retained as a negative~     control sample. The membrane sample was retrieved 7 days after initial surgery. At 14 days~     the suture was removed and a new control was performed within 1 month. A sample from the~     negative control, test and control group was analyzed from each patient. The specimens were~     fixed in a 10% formalin solution, dehydrated in a series of alcohols, embedded in paraffin,~     and sectioned in 4-5μ. The sections were stained with hematoxylin and eosin and examined~     with an Olympus BH-2 optical microscope. The stained sections were photographed with a~     digital camera mounted on an optical microscope at magnification (x100, x200 and x400).~     According to the findings of the present study, we can conclude that CMs exhibit rapid~     degradation when exposed to the oral environment. Histological interpretation suggests that~     CMs immersed in 50mg/ml TTC solution delay the CM degradation when exposed to the oral~     environment. Statistical evaluation did not show any difference in bacterial colonization~     and inflammatory response, but the findings may also be affected by the limited sample size.~      The limits of the present study are the absence of histomorphometric analysis, the sample~     size, and the lack of a long-term evaluation with clinical evidence of the advantages of~     this technique. More clinical studies in humans are require to confirm the effect of TTC in~     CMs degradation before we can make recommendations.~   "
76354|NCT02057913|"~     VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine~     chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days,~     four cycles to be given prior to formal re-staging).~   "
76355|NCT02057900|"~     The purpose of the study is to assess the feasibility and safety of a transplantation of~     cardiac-committed progenitor cells derived from human embryonic stem cells in patients with~     severe heart failure.~   "
76356|NCT02057887|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     doses of HM10660A in subjects with chronic hepatitis C(HCV).~   "
76357|NCT02057874|"~     This pilot clinical trial examines how well different imaging biomarkers acquired using~     3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response~     to transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma.~     Compared to conventional imaging, multi-parametric 3-Tesla MRI offers the ability to~     quantitatively measure tissue structural, functional, cellular, and molecular properties,~     providing a more robust, clinically relevant method for assessing cancer response to~     therapy.~   "
76358|NCT02057861|"~     In this study the investigators aimed to compare the time of antagonism and intensity of~     effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic~     patients.~   "
76359|NCT02057848|"~     Backgrounds/Aims: It was the aim to prospectively study the optimum regime of preventive~     carbohydrate administration for prevention of hypoglycaemic episodes during a standardized~     bout of physical activity.~   "
76360|NCT02057835|"~     BI 691751 is currently being developed to inhibit growth and prevent rupture of~     atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events~     in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to~     investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and~     Japanese male volunteers.~   "
76361|NCT02057822|"~     The ocular surface may be the seat of an inflammatory process in many pathology as vernal~     keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells~     themselves and the constituent cells of the target organ, are the main factors that cause~     inflammation. The main objective of our study was to compare the concentration of 40~     cytokines in vernal keratoconjunctivitis and in control subjects.~   "
76419|NCT02057055|"~     Recent research in the investigator's lab has shown that bacteria are present not only on~     the outer surface of our skin, but also in the deeper components as well. In this study, the~     investigator will study the bacteria present in different components of the skin including~     the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these~     bacteria change after repeated use of different commercially available hand soaps. It is~     expected that the bacteria populations in the different skin components will change with the~     use of different soaps.~   "
76362|NCT02057809|"~     Developmental disability is a severe chronic disabled condition caused by mental or physical~     impairments. Children with developmental disabilities may face life-long difficulties in~     motor functioning, self-care, condition, communication, and independent living. They often~     receive rehabilitation services to promote daily functions and participation in home,~     school, and community lives.~      Family-centered service has been considered as best practice in pediatric~     rehabilitation. Therapists encourage children with developmental disabilities and their~     parents to participate in decision making and implementing process of intervention, and~     provide intervention plan that best fit their family needs. Research shows that for children~     with developmental disabilities, family-centered services can enhance children's~     development, decrease parenting stress, promote emotional wellness, and increase parental~     satisfaction to services. Though the family-centered concept has been considered as~     relevant in pediatric rehabilitation, there are still difficulties, as well as a lack of~     evidence regarding its implementation in practice.~      Reflecting the trend of family-centered medical care, the benefits of national health~     insurance in Taiwan for early intervention outpatient care will emphasize on family-centered~     intervention. The range of benefits may include communication with parents, parental~     education, consultation and instructions for home programs. Besides, outcomes of~     family-centered intervention will be treated as an important index for monitoring the~     quality of medical services.~      Given that there is a lack of investigation regarding the family-centered pediatric~     rehabilitation, the purposes of this one-year research project are to investigate the~     implementation of family-centered pediatric rehabilitation for children with developmental~     disabilities and to identify related influencing factors. This study will provide empirical~     evidence for family-centered services in Taiwan.~   "
76363|NCT02057796|"~     In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections~     are leading causes of early death in patients who initiate antiretroviral therapy (ART) with~     advanced immunodeficiency.~      We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the~     introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and~     no overt evidence of TB will reduce the risk of death and invasive bacterial infections.~     This strategy will be compared to one of extensive TB testing using point-of-care tests~     (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only~     patients with at least one positive test suggestive of TB.~   "
76364|NCT02057783|"~     Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a~     physical activity program will optimize 24-hour blood pressure control in patients with~     OSA-related resistant hypertension.~   "
76365|NCT02057770|"~     The purpose of this research study is to look at overall health status and how acute myeloid~     leukemia (AML) responds to a stem cell transplant when followed with cyclophosphamide. Some~     participants enrolling in this study may receive a transplant from a sibling, some may~     receive a transplant from a matched unrelated donor, and some may receive what is called a~     haploidentical transplant. A haploidentical stem cell transplant is a type of transplant~     that occurs when a person who needs a transplant cannot find a donor who exactly matches~     their tissue type (either among family members or through a matched unrelated donor). When~     no matched donor is available, half-matched related (haploidentical) donors may be used.~     Haploidentical donors are first degree relatives such as siblings, children, or parents.~      People who undergo a stem cell transplant can experience complications such as rejection of~     the stem cell transplant or severe graft-versus-host disease (GVHD). GVHD occurs when some~     of the cells from the donor attack the recipient's tissues, resulting in mild, moderate, or~     even life-threatening side effects to the recipient's skin, stomach, intestines, and liver.~     However, recent research has shown that receiving cyclophosphamide after stem cell~     transplant can improve the outcomes of the transplant, and that is the purpose of this~     study.~   "
76366|NCT02057757|"~     Respiratory viruses are a significant cause of hospitalization for respiratory tract~     infections. This study will evaluate the safety, effectiveness, and tolerability of~     nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are~     hospitalized.~   "
76367|NCT02057744|"~     To quantify potential short- and long-term benefits of robotically-guided minimally invasive~     spine surgery (MIS) for adult patients with lower back degeneration, in comparison a~     matching group of control patients operated in a minimally invasive approach whether~     freehand or with image guidance or navigation techniques.~   "
76368|NCT02057731|"~     The purpose of the study is to determine whether carrier status for any type of glycogen~     storage disease (GSD) predisposes the carrier to GSD markers, like high cholesterol, by~     testing blood, urine, and saliva samples.~   "
76369|NCT02057718|"~     This is an open label study in children with Progressive Familial Intrahepatic Cholestasis~     (PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by~     evaluating the effect of LUM001 on the biochemical markers and pruritus associated with~     PFIC.~   "
76370|NCT02057705|"~     This is a prospective, non-interventional, longitudinal study of the natural history and~     function of approximately 60 patients with MTM from the United States, Canada and Europe.~     The duration of the study, including the enrollment period, will be 36 months. Data from the~     study will be used to characterize the disease course of MTM and determine which outcome~     measures will be the best to assess the efficacy of potential therapies.~   "
76371|NCT02057692|"~     The study is a randomized, double-blind, placebo-controlled study in children with Alagille~     Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on~     pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with~     ALGS.~   "
76382|NCT02057536|"~     The objective of this study is to determine if patients taking aromatase inhibitors (AI),~     who are experiencing joint discomfort and stiffness, would have reduction in this discomfort~     and stiffness by participating in a directed exercise program. The overarching objective is~     to improve patient compliance with the medication and ultimately clinical outcome.~      In this pilot study, we will utilize a scientific approach for proof of concept employing~     both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and~     subjective (patient perception) methods to support an evidence based clinical plan. Patients~     will be divided into two cohorts. Group A will receive AI therapy with a directed exercise~     program. Group B will receive AI therapy without a directed exercise program. Data will be~     collected when both cohorts of patients enroll in the study, at the end of PT for Group A~     and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT~     evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that~     includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression~     scale, and pain level scale.~   "
76383|NCT02057523|"~     The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria~     associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.~   "
76420|NCT02057042|"~     The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus~     enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care~     at three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).~   "
76372|NCT02057679|"~     Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20%~     of symptomatic patients.~      Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates~     forms of diseases and antibiotic therapy in the postoperatory of these patients remains~     under discussion. However in the beginning, AC presents itself as an steril process, the~     obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis,~     as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a~     significant factor associated with total, as well as infectious, operative complications.~     Regarding this, for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the~     best treatment after LC in patients with mild and moderate cholecystitis without~     intraoperative complications such as bile peritonitis, cholangitis, gallbladder perforation~     or abscess. In the other hand, others do not prescribe antimicrobial treatment after surgery~     in these selected patients.~      There is controversy regarding the postoperative treatment with antibiotics in patients with~     mild and moderate cholecystitis and all the evidence about this topic.~      Therefore, investigators decided to conduct a prospective randomized study in patients~     undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer.~     The patients will be randomized to receive AMC or placebo after surgery. With this study~     investigators intend to prove that are no clinical differences in postoperative outcomes~     between patients treated with AMC and placebo.~      The primary aim of the trial is to assess that there are no benefits in the use of~     postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a~     laparoscopic cholecystectomy was performed.~   "
76373|NCT02057666|"~     To confirm the effect of tasquinimod in delaying disease progression or death as compared~     with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer~     (mCRPC).~   "
76374|NCT02057653|"~     As part of a quality assurance program, the Department of Anesthesiology implemented a~     Goal-Directed Fluid Management training course for all physicians and nurses to provide~     goal-directed fluid management. We intend to assess whether there has been any improvement~     in patient outcomes by analyzing de-identified clinical information that are readily~     available via the medical center electronic medical record system. The time-frame we are~     interested in is one year before and one year after the Goal-Directed Fluid Management~     training curriculum (June 15, 2011 to September 15, 2013).~   "
76375|NCT02057640|"~     This study will look at the safety and tolerability of the new drug MLN9708 in combination~     with the existing drugs panobinostat and dexamethasone among patients with relapsed or~     refractory multiple myeloma. This study will also look at the response and clinical benefit~     of the treatment and the progression-free survival and overall survival of study~     participants.~   "
76376|NCT02057627|"~     Maternal depression and mother-infant relationship dysfunction have reciprocal effects on~     each other. An integrated approach addressing both problems simultaneously may improve~     outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum~     depression and facilitate optimal mother-infant relationships. The purpose of this pilot~     study is to determine the feasibility, acceptability, and preliminary efficacy of PDP.~     Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high~     depression symptom levels) and their 6-week-old infants will be randomized to receive either~     the PDP intervention or a control condition. The PDP intervention consists of 8 home-based,~     nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based,~     mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented~     component focused on promoting positive mother-infant interactions. Control mothers will~     receive usual care plus depression monitoring by phone. Data will be collected at baseline,~     post-intervention, and 3 month follow-up. Assessments included maternal depression~     (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and~     mother-infant interaction.~   "
76377|NCT02057601|"~     The purpose of this study is to determine that periarticular levobupivacaine infiltration~     after surgical fixation of fractured neck of femur will improve the early postoperative pain~     sensation.~   "
76378|NCT02057588|"~     The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from~     implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various~     electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be~     collected to characterize electrical conduction patterns during standard electrophysiology~     exam.~   "
76379|NCT02057575|"~     To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its~     individual components in patients with open angle glaucoma or ocular hypertension.~   "
76380|NCT02057562|"~     Benign adenomas of the colon have the potential to degenerate and become malignant.~     Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors~     like advanced age and male gender are associated with the detection of adenomas. The same~     epidemiological pattern can be found with regard to colon diverticula. Furthermore, western~     world countries report higher incidences of both colorectal carcinoma as well as~     diverticular disease. It is not known whether a correlation exists between both entities.~     Some recent data have postulated higher adenoma detection rates in patients with concomitant~     diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff~     BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found~     this would possibly affect recommendations regarding colonoscopy surveillance intervals for~     patients with and without diverticular disease. The investigators therefore plan to conduct~     the following trial.~   "
76381|NCT02057549|"~     Randomized controlled trial comparing haloperidol combined with conventional therapy and~     conventional therapy alone in patients with symptomatic gastroparesis.~   "
76384|NCT02057510|"~     The purpose of this study is to measure the two-year rate of tooth loss in patients who have~     received external beam radiation therapy with curative intent for head and neck cancer. The~     study will also evaluate the sequelae of radiation therapy and oral complications that may~     occur as a result to receiving radiation therapy.~   "
76421|NCT02057029|"~     Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients'~     anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.~   "
81366|NCT01992419|"~     The purpose of this study is to measure an improvement in the detection rate of cardiac~     arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for~     non-medical operators who receive emergency calls.~   "
76385|NCT02057497|"~     G (guanine nucleotide binding) proteins associating with G protein-coupled receptors (GPCR)~     are key players in the pathogenesis of obesity and diabetes and are targets of~     pharmacotherapeutic inter-ventions. In addition, G proteins binding to GPCRs either directly~     or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight~     management and diabetes treatment. Polymor-phisms of the fat mass and obesity-related~     protein (FTO) gene have been also well characterised and linked to energy intake, body fat~     mass as well as CVD risk and the susceptibility to weight-reducing interventions.~     Stratifying patients according to G protein and FTO-related genotyping may enable a more~     accurate prediction of individual disease courses and responses to therapeutic interventions~     in terms of safety and tolerability as well as efficacy. Although the objectives primarily~     refer to the analysis of G pro-tein and FTO-related genotypes, also other genes of potential~     relevance for the evolution of obesity and/ or diabetes and the response to lifestyle and~     pharmacological interventions may be analysed.~   "
76386|NCT02057484|"~     The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once~     daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft~     recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney~     and liver allograft recipients.~   "
76387|NCT02057471|"~     20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are~     planned to undergo surgery. All patients will be treated with a single dose of 1g~     intravenous ferric carboxymaltose (FERINJECT).~      It is hypothesized that intravenous iron supplementation is efficacious at raising~     haemoglobin levels and reduced blood transfusion requirements.~   "
76388|NCT02057458|"~     Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform~     exercise in patients with CF is related to greater death rates, steeper decline in lung~     function, and more frequent lung infections. However, the physiological mechanisms for this~     reduced exercise capacity are unknown. The investigators laboratory recently published the~     first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is~     reasonable to suspect that the blood vessels are involved with exercise intolerance in CF.~     This study will look at how 1) blood flow and 2) artery function contribute to exercise~     capacity in CF.~   "
76389|NCT02057445|"~     The administration of allogeneic third party derived LMP specific-CTLs (special peripheral~     blood cells from another person) that are made specific to fight EBV infection) in Children,~     Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will~     be feasible ( able to be done), safe and well tolerated (no unexpected serious events will~     occur). In addition, potential donors who are EBV positive will be enrolled to donate~     peripheral blood to help build a bank of these specific EBV fighting cell lines.~   "
76390|NCT02057432|"~     This research study is a pilot study designed to evaluate magnetic resonance imaging-guided~     therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the~     investigators are studying if it is possible to use intra-operative MRI to guide surgery.~     The therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite~     at Brigham and Women's Hospital.~      The purpose of this study is to investigate if it is possible to perform the breast~     conserving surgery with the help of intra-operative magnetic resonance imaging in the~     advanced multimodality image guided operating suite. It is hoped that intra operative MRI~     may improve the surgeon's ability to know the exact margins of tumor. Currently,~     approximately 40% of women need to come back to the operating room and have the margins of~     the cancer re-excised.~   "
76391|NCT02057419|"~     The purpose of this study is to answer the following questions: (a) how do sexual and~     reproductive health (SRH) delivery method characteristics play a role in user preference for~     specific SRH methods; (b) can we understand the interplay between salient SRH product~     characteristics and effective use; (c) does effective use differ by indication (e.g.,~     whether the product is for contraception or lubrication); and (d) can this knowledge help~     product developers better understand how to design new SRH products and develop behavioral~     (or point-of-care) interventions to optimize use?~   "
76392|NCT02057406|"~     Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in~     heart failure patients with moderate to severe major depressive disorder.~   "
76393|NCT02057393|"~     The initial treatment for most people with melanoma involves wide excision of the skin and~     sentinel node biopsy. As with other cancers, the status of the sentinel node provides~     important prognostic information to the patient and physician. Sentinel node biopsy was~     first developed using only a blue dye. Technetium99, a radioactive protein, was added later~     and provides the ability to image the patient and identify relevant lymph node basins. For~     the last 15 years or so, the standard method of SLN localization includes both tech99 and~     blue dye. While the rates of localization overall are excellent, these methods each have~     drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye~     that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time~     lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel~     nodes (SLN) in patients with melanoma.~   "
76394|NCT02057380|"~     The purpose of this study is to provide access to continued treatment for subjects who~     participated in other Astellas sponsored trials and for whom the investigator feels the~     subject may benefit from continued treatment.~   "
76395|NCT02057367|"~     Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid~     consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared~     to those who receive 0.9% normal saline solution (placebo).~   "
76406|NCT02057224|"~     Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity~     in addition to reducing blood pressure. The mechanisms are however unclear. The~     investigators hypothesize that renal denervation alters adipose tissue function by reduced~     sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin~     sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study~     investigating anthropometry, peripheral blood samples, body composition, heart rate~     variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.~   "
76431|NCT02056899|"~     This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin~     therapy on the rate of premature birth in women who have had preterm labor.~   "
76396|NCT02057354|"~     The investigators are examining the effects of exercise and cardiovascular fitness on~     cognitive processes, brain function, and the amount of several proteins in the blood. These~     proteins include a hormone called cortisol, also known as the stress hormone, and a growth~     factor called brain-derived neurotrophic factor (BDNF). The stress hormone cortisol is~     produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence~     cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and~     in the body. It plays a role in the growth, maturation, and maintenance of these cells. The~     amount of this protein in blood samples is therefore an indicator of healthy nerve cell~     function. Here, the investigators are investigating if exercise improves brain function by~     changing BDNF levels. Participation in this research study will take approximately 4 months.~     During this time, participants will make four initial study visits. The first visit is for~     informed consent and screening, the second and third visits are for baseline fitness~     testing, and the fourth visit is for a blood draw, cognitive testing, and a functional~     Magnetic Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that~     uses a magnetic field to take pictures of the brain while a person performs a given task.~     It will take up to approximately three weeks to complete these initial four study visits.~     Following the four initial study visits, the exercise-training program will begin.~     Participants will be randomized to one of two training programs: an aerobic exercise program~     and a non-aerobic exercise program consisting of strengthening, balance and stretching~     exercises. The exercise training program will last 12 weeks. There will be three one-hour~     exercise sessions per week. After completion of the exercise-training program, participants~     will attend three follow-up study visits. The first two follow-up visits are for fitness~     testing. The third and final follow-up visit is for a blood draw, cognitive testing, and an~     MRI exam.~   "
76397|NCT02057341|"~     This is a Phase 2 pilot study, involving a 48-week treatment period, designed to test the~     effectiveness of investigational study drug ARRY-371797 in treating patients with~     symptomatic genetic dilated cardiomyopathy due to a lamin A/C gene mutation, and to further~     evaluate the drug's safety. Approximately 12 patients from the US will be enrolled in this~     study.~   "
76398|NCT02057328|"~     Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective~     beta-adrenergic blockers in treatment of arterial hypertension and in improvement of~     arterial stiffness has been established in previous studies among the hypertensive~     population. The present study is a comparison of the performance of two drugs, telmisartan~     and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial~     stiffness of patients with stage I arterial hypertension.~      Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement~     devices and the method of pulse-wave velocity analysis. The effects of telmisartan and~     nebivolol are going to be compared for a total time period of 12 months.~      The aim of this project is to determine whether the expected decrease in arterial stiffness~     of subjects with stage I arterial hypertension can be attributed to the blood pressure fall~     solely, or to other factors as well. These factors are possibly dependent on the action of~     these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral~     vasodilatory actions.~      The present study is going to be the first comparative test of the anti-hypertensive effects~     of the two pharmaceutical substances in 12 months' time, and of the elimination of total~     cardiovascular risk in terms of primary prevention of cardiovascular attacks.~   "
76399|NCT02057315|"~     This is a Phase Ib, 12-week, multi-center, randomized, double-blind, cross-over,~     placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo~     in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe~     migraine headaches (2-8 per month).~      This study is designed to describe the efficacy and safety of ELS-M11 as compared to~     placebo.~   "
76400|NCT02057302|"~     Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS),~     which plays a dominant role in leading to CHD.~      Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus).~     It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino~     acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in~     a guideline for China adult dyslipidemia prevention.~      This study aims to evaluate the benefit and side effect of Xuezhikang, a potential~     alternative drug of statins, for patients with dyslipidemia, and thus provide further~     evidence for clinical application.~   "
76401|NCT02057289|"~     The purpose of this research study is to examine the pharmacokinetics (the process by which~     a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when~     it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These~     children are at high risk for developing invasive fungal disease due to their compromised~     immunity and associated variable degree and duration of neutropenia. Currently, children who~     receive micafungin are given daily or alternate day dosing. The investigators will give a~     ONE TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The~     investigators goal is to obtain comparable micafungin drug concentrations at the end of 96~     hours (4 days) as compared to lower dose at every 24 hour dosing. The investigators dosing~     proposal is likely to be effective prophylaxis for immunocompromised patients and would~     broaden its applicability to larger populations.~   "
76402|NCT02057276|"~     The purpose of this study is to determine whether Repetitive Transcranial Magnetic~     Stimulation (rTMS) can augment occupational therapy in improving motor function in children~     (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis~     from either stroke or cerebral palsy.~   "
76403|NCT02057263|"~     Vaccines are one of our most effective public health tools but many who need them don't~     respond well and are not protected. Adjuvants boost immune responses and are commonly~     included in vaccine preparations. Bisphosphonates are the most commonly prescribed treatment~     for osteoporosis and may represent a new class of adjuvant. Bisphosphonates are well~     tolerated with chronic administration and have very few adverse effects. Research suggests~     that these medications can stimulate the immune system.~      Bisphosphonates are of special interest in populations with impaired immunity and an~     inability to amount protective antibody responses following immunizations. We propose a~     pilot study to evaluate the clinical relevance of this finding in humans. We will study the~     effect of bisphosphonates on quantitative humoral immune response to hepatitis B vaccine in~     healthy older volunteers who have not previously received this vaccine.~   "
76404|NCT02057250|"~     Primary Objective:~      To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA)~     patients.~      Secondary Objective:~      To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus~     prefilled syringes (PFS).~   "
76405|NCT02057237|"~     1. The primary objective of this study is to assess the feasibility of treating patients~          with metastatic castration resistant prostate cancer with mitotane. Secondary~          objectives are to assess safety and tolerability as well as response rate of therapy~        2. To assess the toxicity of Mitotane in men with HRPC~        3. To assess the relationship between baseline serum adrenal androgens and their response~          to Mitotane~   "
76460|NCT02056522|"~     The use of MDS to access the presence of melanoma in the skin.~   "
76409|NCT02057185|"~     Diseases do not only have a physical role in people's live, but they usually involve changes~     in life as whole. They may modify the structure of the conjunction with life setting, thus,~     deeply impacting relationships with others. While clinical results of new therapies for~     hematological diseases are well documented in scientific literature in terms of prolonged~     life expectancy or remission from disease, less is known about problems and barriers~     preventing the return of patients with a chronic blood ailment to everyday life.~      Indeed, there are no published data on this topic within the Italian context. The present~     explorative study aims at identifying the main problems with which patients affected by a~     Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors~     associated with work reintegration and, finally, to understand the need for facilitators~     enhancing reintegration outcomes.~      Results from this study will be also helpful to raise consciousness about the problem of~     reintegration into the labour market of workers with CHD and to call for awareness campaigns~     for the general public and health professionals.~   "
76410|NCT02057172|"~     The purpose of this study is to determine the optimal dose or doses of HM11260C, when~     administered once a week under the skin, to improve the control of blood sugar levels in~     patients with early-stage type 2 diabetes mellitus (T2DM).~   "
76411|NCT02057159|"~     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study~     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary~     Progressive SPMS~   "
76412|NCT02057146|"~     Single operater pancreatico-cholangioscopy is performed through the working channel of~     conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems~     is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.~      Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation~     of suspected premalignant lesions in the biliary duct and in the pancreas.~   "
76413|NCT02057133|"~     The main purpose of this study is to evaluate the safety of a study drug known as LY2835219~     in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane,~     exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer~     that has spread to other parts of the body.~   "
76414|NCT02057120|"~     The objective of the project is to investigate the influence of application of Kinesio~     Taping in young athletes in football, muscle strength and muscle activation in the~     performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted~     a randomized, placebo-controlled and double-blind. 24 individuals will be athletes who fit~     the criteria for inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping)~     and will be submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic~     evaluation and electromyographic of Rectus Femoris dominant lower limb. Then the~     intervention shall be carried out with application of Kinesio Taping for activation of~     rectus femoris muscle group and placebo intervention Kinesio Taping with application of~     Kinesio Taping of transverse way the rectus femoris without tension in the Placebo group~     Taping. The volunteers will be re-evaluated 30 minutes after application of the technique~     and 12:0 am after with the same tests for that later can be compared the results obtained in~     each group. Analysis: will be achieved statistical tests and adopted a significance level of~     5 percent~   "
76415|NCT02057107|"~     Compare the overall survival of patients with the addition of docetaxel to the overall~     survival of patients treated with SBRT and cetuximab alone. In addition, we will determine~     the difference in progression free survival (PFS), the rate of local recurrence (LR) and of~     distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving~     SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS,~     LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment~     and then randomized to either the control arm (cetuximab and SBRT only) or the experimental~     arm (cetuximab, SBRT, and docetaxel).~   "
76416|NCT02057094|"~     The purpose of this study is to evaluate the physiological consequences of extreme military~     training and determine whether protein supplementation enhances recovery by promoting gains~     in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist,~     Escape (SERE) school at Camp Lejeune, North Carolina.~      SERE school may be an ideal setting to assess nutritional interventions that promote~     recovery from severe military operational stress, and identify innate or experiential~     variables that may lead to increased levels of resilience in Warfighters. Our laboratory has~     recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and~     stress-related hormones increased dramatically, with concomitant reductions in circulating~     anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which~     probably included lean body mass. The effects of severe operational stress induced by SERE,~     particularly the loss of lean mass, may degrade physical performance, increase injury risk,~     and compromise military readiness. Under controlled laboratory conditions, consuming high~     protein diets or supplemental high-quality protein promotes muscle protein retention,~     enhances muscle protein synthesis, and protects lean body mass in response to stress.~     Whether consuming supplemental protein promotes lean mass recovery and physiological~     resilience following a 'real-world' military stress has not been determined. Further, the~     level of supplemental protein necessary to optimize recovery from extreme military~     operational stress has not been elucidated.~      Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial.~     Using complex body composition measurements, kinetic modeling of human metabolism, blood~     sampling and cognitive and nutrition questionnaires, the consequences of SERE and the~     efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will~     be assessed.~      We hypothesize that consuming a specially formulated, high-quality supplemental protein~     ration item will speed recovery of lean body mass, physiological, and psychological~     resilience following extreme military operational stress.~   "
76417|NCT02057081|"~     This project addresses the rehabilitation and mental health needs of married combat Veterans~     post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) by~     providing psychoeducation, communication and problem solving skills in a multifamily group~     (MFG) setting. In this group, Veterans and spouses/cohabiting partners learn customized~     therapeutic strategies to help compensate for mTBI deficits and promote Veteran community~     integration, interpersonal and emotion regulation skills, and marital satisfaction. The~     effectiveness of the skills-based MFG will be compared to that of a health education group~     which offers a supportive environment and basic education without skills training through a~     randomized clinical trial. As there is currently no family-based intervention for Operation~     Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA~     spectrum of services, this intervention fills a crucial gap in healthcare for our newest~     Veterans.~   "
76499|NCT02056015|"~     This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to~     assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of~     [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic~     Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their~     treatment plan will be eligible for enrollment.~   "
76500|NCT02056002|"~     Fragmentation of care can lead to poor treatment adherence in patients with chronic medical~     conditions which can, in turn, lead to adverse health consequences, poor quality of life,~     and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient~     patient education, time delays in delivery of care, lack of adequate healthcare~     coordination, or difficulty accessing various healthcare providers across a front desk which~     serves as a healthcare bottle-neck. Better efficiency in healthcare delivery, with greater~     connectivity through knowledgeable and trained peer volunteers and inexpensive cell-phones~     integrated by a smart telephone exchange may alleviate some of the care and communication~     burden faced by the healthcare system. Specifically, such community health education~     volunteers (peer-buddies) who are experienced in managing their disease condition may be~     able to impart knowledge and confidence to a recently diagnosed patient in a much more~     personalized manner than that of a group therapy session. An additional important advantage~     is the peer-buddy's ability to relate to the patient in a manner consistent with their~     social, ethnic, and cultural believes without language barriers or differences that may stem~     from socioeconomic strata. We will use sleep apnea as an example condition to test the~     effect of a peer-buddy helper (combined with the universal availability of personal cell~     phones) on the problem of poor care coordination and treatment adherence to the CPAP~     treatment for sleep apnea. Sleep apnea is a very common condition that affects 7-12% of the~     US population, and if left untreated, can lead to poor health and even death through its~     effects on high blood pressure, heart disease, stroke, and motor vehicle accidents.~     Fortunately, CPAP therapy can lead to a 3-fold reduction in such consequences, but patient~     adherence to such CPAP treatment is generally poor. We have recently completed a small study~     that demonstrated improved usage of CPAP treatment by patients receiving help from a~     peer-buddy with excellent results. We propose to further enhance the peer-buddy~     community-volunteer concept in our proposed research by combining this with cell-phone~     technology and a telephone exchange that improves access to healthcare providers,~     technicians, and home care companies. We hope to show that active community participation by~     experienced lay individuals assisted by the universal availability of cheap cell-phones~     can improve the reach and effectiveness of our healthcare system in improving the health and~     well-being of our patients. If successful, such an innovative and community-based approach~     can be applied to other chronic medical conditions.~      Hypothesis #1: We hypothesize that patients in the peer-driven intervention with interactive~     voice response (PDI-IVR) group will experience a greater patient satisfaction (measured by~     Likert scale64,70 and PACIC71,72) and perception of care coordination (measured by~     CPCQ72,73) than patients in the usual care (control) group.~      Hypothesis #2: We hypothesize that patients in the PDI-IVR group will experience a greater~     CPAP adherence (measured by device download), patient activation (PAM), and self-efficacy~     (SEMSA) than patients in the usual care (control) group.~      Hypothesis #3: We hypothesize that patients in the PDI-IVR group will experience greater~     improvements in HR-QOL (measured by FOSQ) vigilance (psychomotor vigilance testing) and~     blood pressure than patients in the usual care (control) group.~   "
76422|NCT02057016|"~     The primary objective of this study is to evaluate sustained clinical remission (for the~     definition see below) in patients with inflammatory bowel disease receiving long-term (> 2~     years) scheduled treatment with infliximab.~      Secondary objectives include:~        -  to identify predictors of sustained clinical remission during long-term infliximab~          scheduled treatment~        -  to identify predictors of loose of response during infliximab scheduled maintenance~          treatment~        -  to identify predictors for maintaining clinical remission in patients who discontinue~          infliximab because of long-lasting steroid-free clinical remission~        -  to evaluate percentage of surgery during and after treatment (total follow-up)~        -  to evaluate safety of long-term infliximab scheduled treatment~      List the clinical hypotheses~      Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease~     patients who not tolerate or are not responsive to conventional therapies. Most of~     randomized clinical trials about the use of infliximab in inflammatory bowel diseases are~     limited to 52 weeks and very few data come from some observational studies about results of~     prolonged (over one year) treatment with infliximab. No validated predictors of sustained~     clinical remission or loss of response are available so far. Moreover, few data are~     available about the hypothetical reduction of IBD related surgery in the biological era.~      In this proposal we suggest the following hypotheses:~        -  infliximab scheduled treatment may be efficacious in maintain long-term clinical~          remission;~        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical~          remission during infliximab long-term scheduled treatment may be found;~        -  among clinical, laboratory and endoscopic data some predictors of loss of response~          during infliximab long-term scheduled treatment may be found;~        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical~          remission after infliximab discontinuation because of long-lasting (> 6 months)~          steroid-free clinical remission may be found;~        -  maintenance of remission with infliximab may reduce rates of surgery over time;~        -  long-term scheduled treatment with infliximab may be safe and well tolerated. Results~          from this study may really help clinicians to make practical decisions in these~          particular clinical settings.~   "
76423|NCT02057003|"~     The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens~     in the clinical practice in HIV/HCV-coinfected patients.~      Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is~     different to what is observed in clinical trials in HIV/HCV-coinfected patients.~   "
76424|NCT02056990|"~     Athletes have to participate in screenings in order to reduce injuries. Up-to-now most~     screenings are purely clinically based. Literature, however, indicates the importance of~     knowledge on deviant movement patterns as possible risk factors for injuries. From this~     perspective, the current project aims to measure movement patterns, gait and running in~     young athletes to optimise training and prevent injuries.~      2D- and 3d registration methods, force plate data and pressure plate data will be used to~     document the performance of the athletes.~   "
76425|NCT02056977|"~     The purpose of this study is to:~        -  Compare PEEP level selected by individualized PEEP titration by electrical impedance~          tomography and PEEP level routinely used in post-operative cardiac patients with ARDS;~        -  Compare the stability of the selected PEEP in both groups: individualized PEEP~          titration by electrical impedance tomography and the Control group (default strategy~          currently used in the institution)~        -  Evaluate the agreement between the results of a rapid titration (total procedure~          duration = 5 min) versus an already validated slow titration (total procedure duration~          = 40 min) of the same patient, sequentially. Specifically, degree of collapse and~          degree of distention in each PEEP level, estimated by EIT;~        -  Compare hemodynamic and oxygenation effects during the two maneuvers titration;~        -  Evaluate the stability of the selected PEEP according to the rapid titration (minimum~          PEEP capable of collapsing equal or less 1%) in the maintenance of three variables over~          a four hour period: arterial oxygenation, respiratory system compliance, and degree of~          collapse by EIT;~        -  Compare these results (evolution of the three variables, within 4 hours) compared to~          control (default strategy currently used in the institution) group.~        -  Evaluate collapse amount determined by electrical impedance tomography (collapse < 1%)~          and compares with collapse amount determined by pulmonary ultrasound during PEEP~          titration and pulmonary recruitment maneuver .~   "
76426|NCT02056964|"~     The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical~     decision aid for the care of patients with chest pain, in a real-world clinical setting.~     This will be accomplished through the building of a transformative collaboration between~     research, education, and health systems operations to more effectively and efficiently~     provide patient care.~   "
76427|NCT02056951|"~     The primary aim of the study is to analyse the long-term effectiveness of an~     interprofessional and interdisciplinary rehabilitation program named PASTOR, with a~     biopsychosocial approach for participants with chronic non-specific low back pain (CLBP)~     compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in~     Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program~     PASTOR would result in a significantly higher increase in functional ability 12 months after~     completion of the program in comparison to the standard inpatient MOR. The investigators~     further hypothesize that PASTOR would lead to significantly larger improvements regarding~     pain-related cognitions, pain coping strategies, physical activity, health-related quality~     of life, and back pain episodes compared to the standard inpatient MOR.~   "
76428|NCT02056938|"~     The primary objective of the following randomized open label trial is to demonstrate how low~     immunological risk patients (no anti HLA immunization and first kidney transplantation) but~     diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from~     induction with ATG for preventing delayed graft function compared to Basiliximab.~   "
76429|NCT02056925|"~     · 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle~     contractility. Many indications have been developed in child population. However, the~     comparability of measurements between different software systems is not well defined. We~     choose to compare two software systems very often used in paediatric subjects : Echopac by~     General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to~     children which have normal heart. We compare Strain and Strain rate results between the two~     tests with a study of variability : ultrasound variability, operator variability, reader~     variability.~   "
76430|NCT02056912|"~     Human lipodystrophies (lipoD) represent a heterogeneous group of diseases characterized by~     generalized or partial fat loss, with fat hypertrophy in other depots when partial.3, 4~     Insulin resistance, dyslipidemia and diabetes are generally associated, leading to early~     complications. Acquired lipoD can be generalized, resembling congenital forms, or partial,~     as the Barraquer-Simons syndrome, with loss of fat in the upper part of the body contrasting~     with accumulation in the lower part. The most common forms of lipoD are iatrogenic. In human~     immunodeficiency virus-infected patients, some first-generation antiretroviral drugs were~     strongly related with peripheral lipoatrophy and metabolic alterations. Genetic forms are~     very uncommon: recessive generalized congenital lipoD result in most cases from mutations in~     the genes encoding seipin or the 1-acyl-glycerol-3-phosphate-acyltransferase 2 (AGPAT2).~     Dominant partial familial lipoD result from mutations in genes encoding the nuclear protein~     lamin A/C or the adipose transcription factor PPARgamma. Importantly, LMNA mutations are~     also responsible for metabolic laminopathies, resembling the metabolic syndrome and~     progeria, a syndrome of premature aging. Molecular genetic bases of many rare forms of~     genetic lipoD remain to be elucidated.~   "
76432|NCT02056886|"~     Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this~     way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis~     of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is~     therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid~     unnecessary complications due to extensive axillary surgery (for instance, arm enlargement~     by lymphedema), a limited surgery is frequently performed on the first supposed invaded~     lymph-nodes (LN) called sentinel LN technique; if the sentinel LN are not invaded,~     extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel~     LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen~     slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be~     misdiagnosed. That is why a recent molecular biology method has been developed in which the~     total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid~     analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing~     the LN metastatic invasion. A standardized automated technique is available with a mean time~     of 30 to 50 minutes according to the number of analyzed LN.~      In 12 international studies (2830 cases) the consistency between OSNA technique and final~     pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast~     carcinomas cells don't express CK-19 protein.~      The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing~     slightly the operation time; however it allows to avoid the immediate and long-term~     complications due to the radical LN axillary surgery in case of negativity of the sentinel~     LN procedure. To date, the three techniques including extemporaneous examinations (OSNA or~     classical methods) or not (classical pathological analysis) have their own advantages and~     drawbacks.~      SAGE study main objective is to compare these three techniques in terms of direct costs~     and Quality of Life impacts. The superiority of any of these three techniques is not the~     purpose of SAGE study, but the economic burden of OSNA technique in comparison with the 2~     others in the standard setting in France.~      Quality of Life and Pain evaluations will be performed immediately after surgery and during~     the 6 months after.~   "
76433|NCT02056873|"~     The purpose of this study is to evaluate the effectiveness and safety of deep brain~     stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).~      This investigation will (1) test the hypothesis that centromedian (CM) continuous brain~     stimulation will be an effective, safe method for the treatment of tics in medication~     refractory TS, (2) will define the intra-operative and post-operative physiological changes,~     and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an~     alternative to chronic DBS in TS.~   "
76434|NCT02056860|"~     The purpose of this study is to test a lung air vibrator device for vibrating air inside the~     lung. This exploratory diagnostic trial will test a novel and non-invasive means of~     detecting lower airway infections using exhaled breath sample.~   "
76435|NCT02056847|"~     Primary Objective~      : To evaluate that there is no different effect on HbA1c between routine lipid lowering~     therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic~     patients with impaired fasting glucose (IFG).~      H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4~      µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in~     the control drug (Pitavastatin 2 MG)~   "
76436|NCT02056834|"~     The primary objective of this study is to observe the safety, the radiological and clinical~     outcomes of chronOS Inject after having been used as bone void filler in internal fixation~     of proximal tibial fractures.~   "
76437|NCT02056821|"~     This study investigates if there are hemodynamic alterations in acute stroke that predispose~     patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will~     target recruitment of acute ischemic stroke patients who present to the ED within 12 hours~     of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic~     monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral~     oximetry.~   "
76438|NCT02056808|"~     The purpose of this study is to determine whether increasing doses of SMT C1100 are safe,~     well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular~     Dystrophy (DMD).~   "
76439|NCT02056795|"~     Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account~     for approximately 25% of sports injuries. An estimated 40% of these individuals will~     progress to develop chronic functional ankle instability (CFAI), which can significantly~     affect athletic performance and activities of daily life. Stresses from the injury can~     damage the ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle~     proprioception is critical for balance and that individuals with CFAI demonstrate decreased~     proprioception and altered muscular function, which impairs postural stability. The goal of~     this study is to determine if a single application of electroacupuncture can have an~     immediate positive outcome related to balance in individuals with CFAI.~      Methods: This single blinded randomized trial will include 12 subjects receiving a single~     application of electroacupuncture and 12 subjects in the placebo group receiving sham~     electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle~     sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed~     pre- and post-treatment using force plate data during a single-leg stance and via the Star~     Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and~     non-traditional points on the medial aspect of the leg will be used for the sham~     electroacupuncture group. Both will be connected to the electrical stimulation unit for 10~     minutes. Results from this study may inform future research investigating the ability of EA~     at decreasing the risk of ankle sprains, improving perceived stability, and reducing the~     risk of subsequent degenerative changes.~   "
76440|NCT02056782|"~     A Pilot Study of ODSH in Acute Myeloid Leukemia~   "
76441|NCT02056769|"~     Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of~     developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a~     major cause of stroke and death following SAH. A special type of CT scan, called CT~     perfusion, analyzes regional blood flow in the brain. We hypothesize that CT perfusion scans~     performed on admission and day 6 post-hemorrhage will enable us to predict which patients~     will go on to develop vasospasm.~   "
76442|NCT02056756|"~     Open-label phase Ib/II, multicenter, international non-comparative trial. This study is~     designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by~     a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.~      Patients will be evaluated at scheduled visits in up to 4 study periods:~      pretreatment, treatment, maintenance and long-term follow-up (LTFU).~   "
76443|NCT02056743|"~     The purpose of this study is to evaluate the possibility of drug interactions before and~     after taking red ginseng or fermented-red ginseng by estimating metabolic rate of indicator~     drugs for cytochrome P450 and P-glycoprotein.~   "
76516|NCT02055794|"~     The goal of this research is to investigate three different methods of perineal skin closure~     during second-degree perineal wound repair and determine which method is associated with the~     least amount of patient pain.~      Null hypothesis: There will be no difference in patient pain among the three different~     methods for second degree perineal wound repair.~   "
76444|NCT02056730|"~     The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than~     or equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to~     receive medication and a control group that did not receive the medication. By group to~     receive in those taking 25 mg per day to get the default dose and the dose is adjusted~     according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg~     every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose , with a maximum~     dose of not more than 100 mg per day (weeks 3, 6 , 9).~      After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid~     glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track~     during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose~     adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be~     stop taking medication for patients in the control group will receive standard treatment .~     Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the~     level of parathyroid hormone with vitamin D sterol.~      While participating in the research are not allowed to adjust the amount of vitamin D sterol~     in the two groups . But the amount of dialysate calcium phosphate binders and can be~     adjusted as appropriate to healthcare is fine .~   "
76445|NCT02056717|"~     The primary purpose of this study is to investigate the effects of dexamethasone on~     inflammatory reactions after uterine artery embolization. The secondary purpose of this~     study it to investigate the effects of dexamethasone on postembolization syndrome (severe~     pain, nasea and vomiting).~   "
76446|NCT02056704|"~     The reason the investigators are doing this study is to compare the results of angiography~     versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are~     blocked.~   "
76447|NCT02056691|"~     This pilot study looks to explore the biological effects of exercise on cancer and muscle~     cells using a two week exercise program (HIThigh intensity training) on 20 patients with~     newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery.~     Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the~     feasibility of recruiting participants to and carrying out a two week preoperative exercise~     program in patients with colorectal cancer.~   "
76448|NCT02056678|"~     The objective of this study is to determine if IV acetaminophen administered~     intraoperatively can decrease the dose of narcotics required for adequate pain control and~     shorten recovery time in the PACU specifically in obese patients at risk for obstructive~     sleep apnea.~   "
76449|NCT02056665|"~     RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF~     MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)~   "
76450|NCT02056652|"~     Preterm birth (PTB) is associated with over one million infant deaths annually worldwide.~     The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries~     occurring at less than 37 weeks gestation annually. The rate of PTB in the United States~     increased to 12.8% in 2006, and remains high compared to almost all other developed~     countries, despite the introduction of many public health and medical interventions designed~     to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20~     weeks gestation has been shown to significantly reduce the risk of PTB and is currently~     recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a~     strategy for the prevention of spontaneous PTBs in which therapeutic intervention is~     restricted to women with a previous PTB is likely to have a small effect on the overall rate~     of prematurity since only about 10% of spontaneous PTBs arise in women with such a history.~     A major reduction in rates of mortality and morbidity in premature babies will only be~     achieved with increased precision in the identification of women at risk of spontaneous PTB~     and through the development of an effective prevention for this complication. Transvaginal~     ultrasound measurement of cervical length is a reliable screening test for prediction of~     PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women~     with a short cervix, over 30% of women still experience premature delivery and many women~     find daily administration of progesterone to be challenging. Preliminary studies have~     suggested that use of an intravaginal pessary may be effective in preventing PTB. If~     effective this approach would be particularly appealing because of the wide availability of~     pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to~     confirm effectiveness; a well designed, properly powered, prospective randomized trial is~     warranted prior to widespread implementation in clinical practice. We propose such a trial~     to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner~     city Philadelphia population.~   "
76451|NCT02056639|"~     Preterm birth (PTB) is a major health problem and contributes to more than 50% of the~     overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births~     has risen substantially due to the increased use of assisted reproductive technology. The~     rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between~     1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and~     mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the~     United States are twins, as are one in six infants who die in the first month of life.~     Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of~     cervical length is a reliable screening test for prediction of PTB. There is currently no~     effective treatment to decrease the incidence of PTB in women with twin gestations, but~     there is some evidence that the use of a cervical pessary in women with a short cervix has~     promise. If effective this approach would be particularly appealing because of the wide~     availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are~     inadequate to confirm effectiveness; a well designed, properly powered, prospective~     randomized trial is warranted prior to widespread implementation in clinical practice. We~     propose such a trial to study the effectiveness of the pessary in decreasing the incidence~     of PTB in an inner city Philadelphia population.~   "
76452|NCT02056626|"~     The proposed research is designed to determine if the application of classical conditioning~     operations could influence the clinical effects of a regimen of antihypertensive drug~     therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects,~     patients can be effectively treated with smaller cumulative amounts of drug.~   "
76483|NCT02056223|"~     Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in~     preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin~     or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA.~     Aim of this randomized double-blind controlled study is to compare the efficacy and the~     safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We~     hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps~     ameliorating the safety profile of the pharmacological treatment.~   "
76547|NCT02055378|"~     To compare the effect of myopia control between patients treated with low-concentration~     atropine eye drops combined with auricular acupoint stimulation and those treated with~     atropine alone.~   "
76453|NCT02056613|"~     Background:~      - Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve,~     liver, etc.). Researchers are collecting blood samples to develop way to make a special cell~     product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or~     replace organs and tissues, produce blood and immune cells for transfusion, or correct~     inherited immune and blood diseases. iPSCs can be made from many kinds samples, such as~     skin, blood, or hair. This is different from embryonic stem cells, which can only be derived~     from embryos.~      Objectives:~      - To develop new methods to make iPSCs; to identify better ways to collect, produce, and~     grow them; and to make an iPSC bank.~      Eligibility:~      - Healthy adults and adults already in a treatment protocol who have a medical condition~     that could be treated with iPSCs.~      Design:~        -  All participants will be screened with questionnaire, physical exam, and blood and HIV~          tests.~        -  All participants:~        -  Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their~          arm.~        -  Participants already in another protocol:~        -  Will have their blood collected, separated in a lab, and iPSCs grown in large numbers.~          Some may have their sample given back to them as a treatment.~        -  Samples will be kept in the study up to 5 years or until a participant withdraws from~          the study or becomes ineligible to participate, or the study is closed. If participants~          have not withdrawn their consent, they may be contacted in the future to donate again.~   "
76454|NCT02056600|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations~     of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each~     component administered in healthy male volunteers.~   "
76455|NCT02056587|"~     An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line~     therapy in the Russian Federation. Bevacizumab (Avastin) in combination with~     interferon-alpha (IFN) is a recommended first-line treatment for metastatic RCC according to~     clinical recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase~     III trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN~     within 8.5 - 10.2 months and will need sequential therapy.~      Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in~     randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted~     therapy. However, in this trial everolimus was compared with placebo for the treatment of~     patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only~     9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients~     with disease progression on first-line bevacizumab is limited.~      Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on~     bevacizumab with/without interferon alpha has a scientific and practical sense, and it is~     important for Russian Federation.~   "
76456|NCT02056574|"~     This is a randomized, double-blind, placebo-controlled, single-dose study investigating the~     safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing~     endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients~     with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed~     with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of~     the endovascular procedure on Day 1 of the study period. Subjects will undergo interim~     procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.~   "
76457|NCT02056561|"~     Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of~     anesthesia and studies have shown that these anesthetics cause a variety of changes in~     oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is~     similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene~     toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol~     infusion anesthesia on the oxidant and antioxidant systems of patients undergoing~     laparoscopic cholecystectomy.~      Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II,~     score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia~     were included in the study. Patients were divided into 3 groups as total intravenous~     anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n:~     15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups~     for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2%~     sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50%~     air and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for~     the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that.~     Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and~     after the operation venous blood samples were taken to evaluate the levels of glutathion~     peroxidase, total oxidants and antioxidants.~   "
76458|NCT02056548|"~     Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after~     final chemotherapy and they revealed that many of the patients who stopped preemptive~     antiviral drug within 6 months experienced viral reactivation. Based on the study results,~     guidelines recommend that preemptive antiviral therapy should be maintained for at least 6~     months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or~     longer after final chemotherapy without definite evidences, and this practice increases the~     medical expenditure a lot. Therefore, the investigators are going to find out the proper and~     safe duration of preemptive antiviral therapy which can be a good reference in the future~     practice.~   "
76459|NCT02056535|"~     The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention~     and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a~     motivational intervention delivered by a Health Promotion Advocate, relative to standard~     care with and without assessment, on a reduction in heavy drinking and alcohol-related~     problems in the emergency department (ED) at the U.S.-Mexico border; and, 2) identify~     variables that are related to effectiveness of the intervention and that predict successful~     treatment outcome. Patients will be re-assessed by telephone at three and twelve months to~     evaluate outcomes.The specific hypotheses to be examined in this proposal are: 1) the~     motivational interview will lead to significantly greater reductions in the maximum number~     of drinks on an occasion and in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month~     follow-up compared to standard care without assessment (those who screen positive but are~     not assessed) as well as compared to standard care with assessment; 2) the motivational~     interview will lead to significantly greater reductions in number of drinking days per week,~     average number of drinks per day, maximum number of drinks on an occasion, RAPS4 score, and~     number of negative consequences of drinking at 3-month and 12-month follow-up compared to~     standard care with assessment; 3) a positive breath alcohol concentration (BAC) at the time~     of the ED visit and/or self-reported drinking prior to the event resulting in the ED visit~     will be positively predictive of effectiveness of the intervention; 4) attributing a causal~     association of drinking and the reason for the ED visit will be positively associated with~     effectiveness of brief intervention; 5) readiness to change (and stage of change) will be~     positively associated with effectiveness of brief intervention; 6) risk taking/impulsivity~     and sensation seeking dispositions will be negatively associated with effectiveness of brief~     intervention.~   "
76461|NCT02056509|"~     Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation~     (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal~     intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally~     accepted according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This~     recommendation emphasizes on the timing and frequency of ventilation during CPR. However,~     poor clinical evidence had been established concerning adequate volume, airway flow and~     pressure in each cycle.~      There are increasing evidence that hyperventilation during resuscitation reduces pulmonary~     venous return and, therefore, compromises cardiac output and circulation. Another research~     reported that using high flow oxygen mask alone during basic life support (BLS) results in~     better survival rate and overall outcome compared with conventional positive pressure~     ventilation.~      Our study applies flowmeter to measure ventilation parameters as frequency, duration,~     exhaled volume and airway pressure on intubated patients who received artificial ventilation~     during CPR. The parameters will correlate with information from accelerometry and capnometry~     simultaneously during resuscitation. . Investigators also focus on the influence of chest~     compression, which increases intra-thoracic pressure considerably. This effect may act~     against positive pressure ventilation and probably minimize the efficiency in each~     ventilation or circulation..~      Details about how to ventilate one patient during CPR include right timing, duration,~     adequate volume and coordination are in debate. Unfortunately, current practice based on~     clinical guidelines emphasizes little on this issue. Investigators are committed to refine~     contemporary practices and hopefully improve qualities of resuscitation.~      Investigators proposed the hypothesis that coordinate chest compression and ventilation may~     minimize the increasement of airway pressure and improve the effect of circulation~   "
76462|NCT02056496|"~     Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are~     metabolized by the human gut microbiota to yield a number of metabolites called urolithins~     (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological~     activities. However, the bioavailability of ellagic acid has been reported to be very low~     and the existing studies are controversial so far. The investigators want to carry out a~     robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two~     types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA~     ratio will be administered. The investigators will analyze blood and urine samples using~     UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:~        -  The pharmacokinetics of EA.~        -  The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins~          production.~   "
76463|NCT02056483|"~     The purpose of this study is to examine if a psychosocial intervention including a nurse~     navigator and systematic symptom screening may reduce psychological and physical symptoms as~     well as health behavior after breast cancer.~   "
76464|NCT02056470|"~     Assess the safety and functionality of the Freedom Knee® system through a multi-center~     clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data~     for:~        1. Range of Motion~        2. Quality of Life measurements using Knee Society Scale (KSS)~        3. Survivorship as defined by 'No Revision' of baseline implant~        4. Quality of Life measurements using the WOMAC Score~   "
76465|NCT02056457|"~     The purpose of this study is to evaluate the effectiveness of selected healthy marriage (HM)~     and responsible fatherhood (RF) grant programs, authorized by by the Claims Resolution Act~     of 2010. The programs are intended to improve the well-being of parents and families in~     domains such as economic self-sufficiency, parenting, and healthy relationships.~   "
76466|NCT02056444|"~     Bleeding during and after total hip replacement surgery is a primary concern to the surgical~     and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and~     decreases surgical bleeding. The investigators commonly administer the drug intravenously~     prior to the procedure. Some patients are unable to receive the drug in this form, because~     of risks related to blood clotting. The investigators know, from studies in total knee~     replacement surgery, that the investigators can deliver tranexamic acid directly to the~     surgical site (topically), with similar benefits and less of the drug absorbed into the~     bloodstream, resulting in less risk to the patient. The investigators seek to find if~     similar benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip~     replacement surgery. The investigators' hypothesis is that the topical form will be~     equivalent, but not better than the intravenous form for reducing intra- and postoperative~     bleeding. The investigators also expect to see decreased levels of tranexamic acid in the~     bloodstream when it is administered topically.~   "
76467|NCT02056431|"~     Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with~     diabetes. People with painful DPN have trouble sleeping, participating in social events, and~     conducting daily activities such as going to the store. Several prescription medications are~     available for the treatment of DPN symptoms, but none work perfectly and all have side~     effects that may be difficult for some patients.~      When patients report their symptoms and side effects to their doctor, they provide the~     doctor with important information to help them make adjustments to treatment that will help~     with symptoms and that the patient can tolerate in terms of side effects. In some cases,~     doctors may encourage patients to make these changes on their own at home based on their~     experience with therapy. However, patients may have a long time between visits to their~     doctor and may have trouble describing their symptoms to their doctor during a brief 10 to~     15 minute visit.~      This clinical trial explores the possibility of computerized telephone calls to patients~     (Interactive Voice Response, IVR, technology) to gather information about treatment~     experiences that can then be reported to the doctor or used to guide patients to make~     changes in how they take the medication. It addresses the following question: Can routinely~     asking patients about their experiences with medications and using that information to~     encourage clinically appropriate titration improve patient quality of life?~      The investigators hypothesize that systematic collection and feedback of information about~     DPN treatment preferences and experience from newly treated patients to their primary care~     physician will facilitate treatment changes that improve patient outcomes~   "
76468|NCT02056418|"~     The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the~     inadequate immune response or overreaction of the immune system against food antigens or~     components of the commensal flora involve it. Corticosteroid therapy is effective for adult~     patients with CD, but it has side effects and can't promote mucosal healing. In recent~     years, Enteral nutrition (EN) is becoming primary therapy in induction and maintenance~     remission of CD, especially in children. But the mechanism of EN in induction and~     maintenance remission of CD is still unclear, and parts of patient have good clinical~     response to EN therapy while other don't. So we design the study to explore whether EN~     treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD~     relates with clinical response.~   "
76497|NCT02056041|"~     Selection criteria for safe hepatectomy for HCC are not well established. The aim of this~     study was the validation of the selection criteria for safe hepatectomy for hepatocellular~     carcinoma.~   "
76469|NCT02056405|"~     Postoperative Ileus is defined as the transient postoperative functional inhibition of~     propulsive bowel activity. The ethiology of this process can best be described as~     multifactorial. In its pathogenesis different mechanisms are involved such as hormones and~     neuropeptides, inflammation, narcotics and the Autonomic nervous system. Is one of the most~     common causes of prolonged hospital stays after abdominal surgery, thereby increasing~     health-care resource utilization. More importantly, it causes patient discomfort in the form~     of nausea, vomiting, and stomach cramps. It has a variable duration but is usually solved in~     3 to 4 days. Prolonged Ileus is associated with postoperative complications like an increase~     on urinary and pulmonary infections, profound venous thrombosis and wound-site~     complications.~      Mosapride is a prokinetic agent that acts as a selective serotonin agonist (5- HT4) that~     facilitates acetylcholine release from the intrinsic plexus. This accelerates gastric~     emptying and propulsive peristaltic movements on the lower intestines. Mosapride has no~     action over the central nervous system therefore the lesser side effects like cardiac~     arrhythmias and extrapyramidal symptoms. For being a safer drug we chose it to be the center~     of our research.~      Two randomized controlled trials studied Mosapride concluding it shortens PI after~     colorectal surgery. However these trials took place on specific populations (Orientals) with~     less than 50 patients and only one of them included laparoscopic treatment specifically.~     Also the end point of these studies didn't consider the impact of PI over hospital stay or~     costs to the health system.~      We therefore decided to conduct a prospective randomized study in patients undergoing~     laparoscopic colorectal surgery for colon cancer. The patients will be randomized to receive~     treatment or placebo after surgery. With this study we intend to prove that patients treated~     with mosapride immediately after surgery suffer from shorter postoperative ileus with~     earlier oral intake and shorter hospital stay.~      The primary aim of the trial is to assess the effectiveness of the use of Mosapride in~     shortening the duration of the Postoperative ileus in patients undergoing colorectal~     laparoscopic surgery. The trial hypothesis is that the standardized use of Mosapride~     immediately after colorectal laparoscopic surgery is safe and accelerates the recovery of~     propulsive bowel activity, thereby shortening postoperative ileus and hospital stay.~   "
76470|NCT02056392|"~     Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc~     interval in healthy male volunteers.~   "
76471|NCT02056379|"~     The study aims to analyze and compare the clinical effects of using inhaled budesonide or~     intravenous dexamethasone in the treatment of postextubation stridor on children admitted to~     the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert~     Einstein.~   "
76472|NCT02056366|"~     The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in~     people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the~     nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may~     cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.~   "
76473|NCT02056353|"~     Most critically ill patients are confronted with hyperglycaemia, which is associated with an~     increased mortality and morbidity risk. Normalising these elevated blood glucose levels by~     intensive insulin therapy may improve patient outcome, but is associated with an increased~     risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised~     software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia)~     blood glucose control in critically ill patients than nurse-directed blood glucose control.~   "
76474|NCT02056340|"~     Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in~     the United States and causing as many as 500,000 deaths worldwide each year. Currently,~     there are only a few treatments for influenza infection and none of these target~     inflammation that can be caused by the virus. This study will test whether the~     anti-inflammatory effects of statins, a class of drugs most often used to treat high~     cholesterol, will decrease the severity of illness in patients who are infected with~     influenza by testing markers of inflammation in the blood and recording resolution of~     influenza illness.~   "
76475|NCT02056327|"~     Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to~     develop monitoring sensors that could be inserted into commercially available oral~     appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.~   "
76476|NCT02056314|"~     This study will compare a computerized tutorial to a brochure in terms of their education~     impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a~     program used by people who seek to bar themselves from further access to the casino or other~     gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with~     Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical~     information to players who choose to reinstate and return to gambling. The goal of this~     study is to determine if this new computerized tutorial decreases the harm of gambling~     experienced by gamblers who are reinstated. For example, are they less likely to relapsing~     to problematic levels of gambling.~   "
76477|NCT02056301|"~     The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling~     pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be~     the difference in pain scores at rest and with activity (coughing, deep breathing and~     movement) during postoperative days 1 -5.~   "
76478|NCT02056288|"~     This study compares nerve blocks to IV pain medicines in children with broken arms. We are~     trying to see if blocking the nerves in the broken arm results in better pain control and~     less side effects than injections of morphine into a vein after surgery for a broken elbow.~   "
76479|NCT02056275|"~     To assess the effect of oral nutritional supplementation with dietary counseling versus~     dietary counseling alone on growth of preschool children over a period of 90 days.~   "
76480|NCT02056262|"~     The primary objective of this study is to estimate the distribution of pathogenic species~     and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and~     Assessment System) corresponding to the severity of dental caries among patients aged 3-45~     years consulting in the Dentistry Departments of the Nîmes University Hospital and the~     Montpellier University Hospital.~   "
76481|NCT02056249|"~     The aim of this study is to use Positron Emission Tomography (PET) imaging to measure~     changes in norepinephrine transporter (NET) concentrations in the brain and periphery of~     healthy individuals during hypoglycemia.~      We hypothesize that during hypoglycemia, NE levels will increase within the brain,~     especially the hypothalamus, and this likely contributes to activation of glucose~     counterregulatory responses. We further hypothesize that during hypoglycemia, NET~     concentrations in key glucoregulatory regions will change in order to sustain or prolong~     sympathetic nervous system activation of counterregulatory responses.~   "
76482|NCT02056236|"~     The purpose of this study is to estimate the effect of medical treatment of~     electro-encephalographic status epilepticus on neurological outcome of patients with~     postanoxic encephalopathy after cardiac arrest.~   "
77837|NCT02038556|"~     The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine~     utility of this program as a high-value care model targeted specifically to our sleep center~     patient population.~      Hypothesis: PIRS will improve from baseline to 2 month follow up~   "
76484|NCT02056210|"~     The objective of this study is to assess whether there are differences in the mobilization~     of CD34+ cells and EPC in response to Mozobil in patients with diabetes mellitus compared to~     subjects without diabetes. Currently, there are no non-invasive methods for the study of~     bone marrow function in humans. This project aims to evaluate in patients with type 1 or~     type 2 diabetes mellitus the ability to mobilize CD34+ cells and EPC from the bone marrow to~     the periphery in response to the exogenous mobilizing agent AMD3100 / plerixafor (Mozobil),~     compared with a group of non-diabetic individuals. While it has been recently shown that~     diabetic patients do not respond to mobilization induced by G-CSF (Filgrastim), the~     investigators herein hypothesize that diabetic patients can adequately respond to~     mobilization induced by Plerixafor~   "
76485|NCT02056197|"~     Motor control exercises have demonstrated a good option for recovery from chronic low back~     pain. The purpose of this study is investigated the effectiveness of an exercise program for~     trunk stabilization performed in stable and unstable surfaces for people with nonspecific~     chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control~     group will receive placebo treatment with shortwave; stable group will receive an exercise~     protocol to stabilize the trunk on a stable surface and unstable group will receive the same~     exercise protocol but performed on an unstable surface.~      We hypothesized the unstable group will present pain reduction and functional improvement.~   "
76486|NCT02056184|"~     The purpose of this study is to determine whether therapy modifications (including addition~     of ultrasound-guided treatment change) can change imaging results in patients with early~     rheumatoid arthritis in a stable clinical disease activity state.~   "
76487|NCT02056171|"~     This study is designed to assess the safety and efficacy of quetiapine as treatment for~     pediatric delirium.~   "
76488|NCT02056158|"~     In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often~     developed at an earlier age and is a significant cause of morbidity despite treatment with~     antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes~     strongly support the hypothesis that the combination of HIV infection and smoking creates~     increased stress in the lower respiratory tract. To examine the underlying factors that~     contribute to the accelerated development of emphysema in this cohort, samples from the~     lower respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected~     will serve as biomarkers for assessing the onset of emphysema.~   "
76489|NCT02056145|"~     Evaluation of the combination of lateral femoral cutaneous nerve single shot and femoral~     nerve single shot block as effective and safe alternative postoperative analgesic~     technique after hip replacement surgery.~   "
76490|NCT02056132|"~     There is an urgent need for a noninvasive method to diagnose bronchial infections and~     exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed~     infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage~     (BAL). However, some patients cannot produce sputum. At the same time the decision of when a~     patient has an exacerbation continues to be very subjective. In this exploratory study, we~     propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible~     markers of inflammation that can assist in a noninvasive way in the determination of~     exacerbations.~   "
76491|NCT02056119|"~     Aerosol delivery during mechanical ventilation has long been a long debated topic. As~     evidence- based knowledge about the delivery of aerosol to the lungs of mechanically~     ventilated patients increases, one piece of the puzzle has remained unexplored; measurement~     of clinically relevant outcomes. The primary aim of this research is to compare clinical~     outcomes (ventilator- associated events (VAEs), length of stay (LOS) in intensive care unit~     (ICU) and total days on mechanical ventilation) when using a traditional jet nebulizer~     versus a newer generation vibrating mesh nebulizer during mechanical ventilation. The~     secondary aim of this research is to identify source of bacteria by obtaining cultures of~     each nebulizer and ventilator circuit and plating them for colony growth and identification.~   "
76492|NCT02056106|"~     This study compares two models for implementing antidepressant treatment in 10 HIV clinics~     in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized~     model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine~     depression screening at each clinic visit for all adult patients by trained expert patients~     at triage, (2) training nurses to diagnose depression and prescribe and monitor~     antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and~     monitoring by hired study psychiatrists. The clinical acumen model also includes routine~     depression screening and ongoing supervision, but it relies on the clinical acumen of~     trained primary care providers to further evaluate and treat patients who show signs of~     depression at screening, as opposed to a structured protocol. The primary aim is to test the~     hypothesis that the nurse-driven protocolized model will result in greater uptake of~     antidepressant treatment and better quality of depression care outcomes. The study will also~     test the hypotheses that treatment of depression results in improved HIV treatment~     adherence, work functioning and consistent condom use.~   "
76493|NCT02056093|"~     In spontaneously breathing mechanically ventilated patients, the adequacy between the~     patient's demand and the level of respiratory support delivered by the ventilator is a major~     clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist~     ventilation (PAV) have been developed to adapt the level of assistance to the patient's~     demand. These two modes have been compared to pressure support ventilation (PSV) but have~     not been compared to each other.~   "
76494|NCT02056080|"~     A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit~     of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive~     Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January~     2005 and December 2011~   "
76495|NCT02056067|"~     The investigators propose to examine 121 postmenopausal women diagnosed with~     hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for~     at least 6 months and are experiencing at least mild arthralgia originating during AI~     treatment, the yearlong effect of exercise vs. attention control (health education), and on~     toxic side effects of AI.~   "
76496|NCT02056054|"~     The purpose of this study is to provide insights into the cause, development and effects of~     de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in~     order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and~     the need for re-transplantation.~   "
76501|NCT02055989|"~     This study is a phase I/II dose escalation trial designed to test the feasibility of~     delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety~     and possible improvement in outcome when the dose is increased.~      This protocol is in fact two studies running in parallel: thyroid cancer patients and~     larynx/ hypopharynx cancer patients. These two groups of patients are being treated~     differently and will be analysed separately.~      The primary objective of this Phase I sequential cohort study was to determine the~     feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced~     high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2~     dose fractionation regimens.~      DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions~      DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily~     fractions and elective nodal levels 54 Gy in 30 daily fractions~   "
76502|NCT02055976|"~     The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C)~     lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two~     weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a~     stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and~     whose LDL-C is not controlled.~   "
76503|NCT02055963|"~     The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce~     certain side effects of surgery in patients with head and neck cancer (such as pain,~     fatigue, and disturbed sleep). In this study, minocycline will be compared to a placebo.~      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
76504|NCT02055950|"~     Trends in organ donor pool are characterized by an increasing age and a shift towards~     cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years~     nowadays represent more than one fourth of the entire donor pool in Italy. This, along with~     an increasing number of patients on the waiting list for transplantation, prompted a growing~     use of organs from subjects older than 60 years that would have been considered unsuitable~     years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient~     has been proposed. To optimize allocation of these organs to single or dual~     transplantation,a scoring system for kidneys, based on biopsy, with scores ranging from a~     minimum of 0 (indicating the absence of renal lesions) to a maximum of 12 (indicating the~     presence of marked changes in the renal parenchyma) has been suggested. According to this~     panel, kidneys with a score of 4 or lower are predicted to contain enough viable nephrons to~     be used as single transplants, those with a score of 5, 6, or 7 can be used as dual~     transplants, kidneys with a score greater than 7 are discarded. The survival of kidney~     grafts obtained from donors older than 60 years and allocated for single or dual~     transplantation on the basis of biopsy findings before transplantation was similar to that~     of single grafts from younger donors. To further improve these results, set-up of strategies~     to preserve organs is crucial to save the residual nephron mass and optimize outcomes of~     these marginal grafts. In this regard, over the past 30 years two methods of kidney~     preservation have been developed. With cold storage, the kidney is flushed once it is~     removed from the donor and placed in an ice-cooled container with preservation solution.~     With the use of pulsatile machine perfusion, the kidney is connected to a machine, which~     pumps a cold solution containing oxygen and nutrients through the kidney. This process~     allows for metabolism to continue in the kidney with end products being removed. The broad~     aim of the present study is to evaluate whether pulsatile machine perfusion of kidneys from~     older/marginal donors may provide better outcomes than static perfusion. To this purpose the~     outcome of recipients of perfused kidneys will be compared with the outcome of historical~     controls receiving non-perfused kidney selected and allocated on the basis of the same~     criteria and matched by gender, age and kidney histologic score.~   "
76505|NCT02055937|"~     The purpose of this study is to study the impact of the immediate implant breast~     reconstruction for patients with mastectomy and postoperative chest wall radiotherapy~   "
76506|NCT02055924|"~     This is an open label, multicenter, dose escalation, phase Ib study to determine the~     recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of~     ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients~     with B-cell malignancies. This dose escalation will be followed by an exploratory expansion~     phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).~      During Part 1 Dose Escalation, the 3+3 design will be applied. Three doses of ibrutinib~     (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation~     Committee. Dose escalation will begin at dose level 1 = 420 mg.~      The dose escalation will be performed for two types of associations in four separate groups~     :~        -  Group A : ibrutinib D1-D21+ R-DHAP~        -  Group B : ibrutinib D1-D21 R-DHAOx~        -  Group Abis : ibrutinib D5-D18+ R-DHAP~        -  Group Bbis : ibrutinib D5-D18 R-DHAOx~      This dose escalation will be followed by an exploratory expansion phase in the same 2 groups~     A/Abis and B/Bbis plus a third one including only mantle cell lymphoma (MCL) in first line~     patients: group C. Patients included in the Group C will receive ibrutinib in combination~     with R-DHAP or R-DHAOx according to the choice of the local investigator at time of~     inclusion of each patient.~   "
76507|NCT02055911|"~     To evaluate the safety of intravitreal ranibizumab repeated injections in patients with~     diabetic macular edema regarding maintenance of retinal ganglion cell function.~   "
76508|NCT02055898|"~     Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment~     and other symptoms, is associated with neither a currently identifiable disease process nor~     major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep~     impairment is common in nearly everyone with CFS, with both daytime sleepiness and~     unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be~     that fundamental regulatory processes that control sleep are disturbed in CFS, leading to~     different effects on sleep and daytime symptoms depending on the subject's prior sleep,~     daytime routine, medication and other factors. The investigators contacts with patient~     groups have indicated that patients are generally confident that on days when their sleep is~     better they perform better in the day. There is growing evidence that deep, slow wave sleep~     (SWS) is altered in CFS, and this may suggest impairment of build up of sleep pressure~     during the day.~      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug~     called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,~     specifically sleepiness and mental performance. This is a safe and well-tolerated drug that~     is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.~      The investigators will study 12 patients diagnosed with CFS using international diagnostic~     guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement~     on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will~     be taken nightly, and the investigators will measure next-day sleepiness, mental performance~     and fatigue, and compare drug and placebo nights.~   "
78041|NCT02035930|"~     The study was done to evaluate the effects of the follicular and luteal phases of the~     menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50~     during propofol anesthesia, in patients with and without preoperative intravenous~     dexmedetomidine .~   "
76509|NCT02055885|"~     In the literature, the effects of acute oxygen administration on exercise tolerance and~     related symptoms have often appeared to be contradictory. Some investigations have reported~     benefits from acute oxygen supply during exertion, including increased exercise performance,~     reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have~     reported no improvement. Recently, we advanced then the hypothesis that some patients would~     be non-responders and even worsen under oxygen treatment. The preliminary results confirmed~     our hypothesis since we demonstrated that while 56% of the patients were improved with~     supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased~     performance and increased dyspnea during endurance exercise with supplemental oxygen).~     However, this was a pilot study offering preliminary insights and tentative conclusions that~     must be confirmed in a larger case series.~      The aims of this retrospective study was :~        1. To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the~          deleterious responses to acute oxygen supplementation in LTOT (long terme~          oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.~        2. To identify the predictive factors among the clinical data (i.e., anthropometric,~          spirometric and gazometric data) and/or functional data recorded during rehabilitation~          program~   "
76510|NCT02055872|"~     Critically ill patients usually require intravenous fluids to correct low blood pressure and~     improve blood flow to vital organs. However, once the patient's blood pressure has improved,~     these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess~     fluid in these tissues, called edema, has been associated with longer ICU stays and higher~     mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema~     is to use diuretics, such as furosemide, which increase urine output.~      To further improve urine output, patients are sometimes given albumin, a protein which helps~     to suck fluid out from the tissues, and keep it in the blood vessel, where it can be~     filtered in the kidney and removed in the urine. Although albumin is often used for this~     purpose, there is little evidence to support it. A large randomized controlled trial is~     needed to determine if albumin plus furosemide is truly more effective than furosemide alone~     in critically ill patients with low levels of blood albumin. We will perform a pilot study~     to assess the feasibility of such a trial.~   "
76511|NCT02055859|"~     Most vestibular schwannomas are benign and slow-growing. Based on that fact, conservative~     management with serial imaging is a viable alternative. For patients who undergo treatment~     because of tumor growth, progressive symptoms, or personal preference, options include~     serial observation, microsurgical resection, fractionated stereotactic radiotherapy, and~     stereotactic single-session radiosurgery.~      Despite improved radiosurgical techniques and lower marginal doses, a recent report has~     shown a somewhat disappointing 10-year actuarial hearing preservation rate of 44.5%, with~     hearing loss developing as much as 6 years after.~      Fractionation of the prescribed dose may takes some advantages from radiobiologic principles~     to reduce toxicity and maintain tumor control.~      Staged frame-based radiotherapy using a 12-hour interfraction interval was successfully used~     at Stanford university and has shown a hearing preservation rate of 77% at 2 years of~     follow-up.~      The aim of the present protocol is to evaluate the hearing preservation, the local control~     and toxicity after single-session (sSRS) or multi-session (3 fractions) radiosurgery (mSRS)~     by using the frameless robotic CyberKnife® system (Accuray Incorporated, Sunnyvale, CA,~     USA).~      In order to investigate about this a randomised controlled double harm (sSRS vs mSRS) trial~     was designed.~   "
76512|NCT02055846|"~     Prostate cancer (PC) represents one of the most common cancers in industrialized countries.~     Patients with localized disease may be treated with surgery or radiation, while androgen~     ablation is used as first-line therapy in patients with metastatic disease. While most~     patients initially respond well to this hormonal therapy, they most ultimately become~     unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC).~     Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in~     two different, large, phase III studies. However, the median overall survival was prolonged~     for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations~     of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent~     androgen receptor (AR) activation, alternative growth factor pathways, and immune system~     escape. Additional therapeutic strategies targeting molecular mechanisms mediating~     resistance, combined with immunotherapy must be developed. One strategy to improve therapies~     in advanced PC involves targeting genes that are activated by androgen withdrawal, either to~     delay or prevent the emergence of the resistant AI phenotype. Recently, a~     scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC.~     Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA)~     increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and~     patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug~     called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite~     OGX-427 efficiency, the functional role of stress induced Hsp27 in castration or~     chemotherapy-induced apoptosis remains undefined. The purpose of this study is to elucidate~     the pathways leading to Hsp27 action in androgen-independent prostate cancer in order to 1/~     Increase the pharmacological safety of OGX-427 and 2/find new specific therapeutic targets~     and treatment strategy for androgen-independent prostate cancer .~   "
76513|NCT02055833|"~     In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with~     impaired quality of life, reduced survival, more frequent treatment interruptions and dose~     reductions. The international guidelines recommend early nutritional support in the presence~     of nutritional risk, as it allows preventing or treating malnutrition and improving the~     clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional~     intervention trials in head-neck cancer patients have been conducted on small samples and~     did not clarify the role of oral nutritional supplements (ONS). Accordingly, although~     current guidelines recommend as grade A the use of ONS associated with dietary counseling~     for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention~     still needs to be evaluated in adequately sized and randomized clinical trials.~   "
76514|NCT02055820|"~     This is a multicenter, open-label, dose-finding study of GDC-0199 administered orally in~     combination with MabThera/Rituxan (R) or obinutuzumab (G) and standard doses of~     cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in patients with~     Non-Hodgkins Lymphoma (NHL). Patients will be randomized to one of two treatment arms of~     GDC-0199 in combination with R-CHOP and G-CHOP. The study will consist of two stages, a~     dose-finding stage and an expansion stage. The maximum tolerated dose (MTD) of GDC-0199 in~     combination with R-CHOP and G-CHOP will be determined during the dose-finding stage.~   "
76515|NCT02055807|"~     The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during~     laparotomy will limit the development of atelectasis and therefore improve the aeration~     score.~   "
76517|NCT02055781|"~     The primary hypothesis of the study is that treatment with either once-daily or twice-daily~     pacritinib results in a greater proportion of patients with thrombocytopenia and~     myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than~     treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥~     50% reduction in total symptom score from baseline to Week 24 as measured by the~     Myeloproliferative Neoplasm Symptom Assessment Form 2.0.~   "
76518|NCT02055755|"~     The goal of this project to begin using a wound research database with clinical decision~     support features at Winthrop University Hospital. A research database is an electronic~     computer system that is used to collect patient information. Clinical decision support is~     the ability for a computer system to provide medical assistance to the doctor through alerts~     and recommendations based on the information entered. The investigators believe that use of~     a wound clinical decision support tool, much like a drug, will improve healing in patients~     diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness~     caused by these wounds. In order to develop a useful clinical decision support tool,~     investigators first need to develop a large research database to determine the data points~     important for wound healing. The investigators will be using the data collected in this~     study for future research and publication. Data will be reviewed to answer questions~     important to diabetic foot ulcer healing and for the purpose of developing the clinical~     decision support alert system.~      After providing informed consent, participants will be asked a series of questions related~     to their past medical history, and relevant wound data will be collected. Study staff will~     photograph the wound at baseline, and once per week until the wound is completely healed, or~     for a duration of six months.~      Participants will be expected to return to Winthrop University Hospital for wound follow-up~     on a regular basis, or as determined by the Principal Investigator.~   "
76519|NCT02055742|"~     To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the~     illumipro-10, with male urine, female urine, physician-collected (medical professional)~     endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic~     patient populations.~   "
76520|NCT02055729|"~     The main objective of this study is to characterize the evolution (over a period of 28 days)~     of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure~     ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic~     bacterial species at the intra-individual and population levels.~   "
76521|NCT02055716|"~     To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male~     volunteers over 7 days with qd or bid dosing~   "
76522|NCT02055703|"~     This study will be a single-center, open-label, drug-drug interaction study in healthy male~     and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect~     of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be~     assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups~     (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In~     Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in~     approximately 18 subjects. In Part C, the effects of donepezil administered in combination~     with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in~     approximately 24 subjects.~   "
76523|NCT02055690|"~     The first part of this study is to find the recommended dosages of a combination of two~     drugs: pazopanib and fosbretabulin, which will be given to female patients with relapsed~     ovarian cancer.~      The second part of the study involves comparing the recommended dose of pazopanib and~     fosbretabulin in combination against pazopanib alone in female patients with relapsed~     ovarian cancer to determine whether the combination is more beneficial that pazopanib on~     it's own.~   "
76524|NCT02055677|"~     Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and~     vegans with respect to their personality profiles, values and empathy through validated~     questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their~     personality, empathy and values~   "
76525|NCT02055664|"~     This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block~     with continuous infiltration of ropivacaine versus placebo.~      Procedure:~      Once consent has been obtained, patients will be randomised into one of the two groups:~     Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a~     catheter inserted by the anaesthetist.~   "
76526|NCT02055651|"~     Introduction: As employees spent most part of their time at the worksite, it provides a~     venue to address multiple individual risk factors and promote health. The America Heart~     Association (AHA) defined cardiovascular health using as metrics smoking status, body mass~     index, physical activity, diet, total cholesterol, blood pressure and fasting blood glucose.~      Objective: Evaluate Bayer employees' cardiovascular health according to the AHA definition~     and the acceptance to engage in lifestyle change programs.~      Methods: By the time of the annual occupational safety periodic medical examination,~     employees will receive an email with information about the cardiovascular health screening,~     exams requisition (fasting blood glucose and total cholesterol) and a copy of the written~     informed consent. If the employee accepts to participate, after providing a written informed~     consent, he will be evaluated according to the AHA cardiovascular health metrics. Data will~     be collected at the occupational safety electronic health record. After medical evaluation,~     employees will receive a printed feedback with their cardiovascular health score and will be~     referred to indicated lifestyle change programs (healthy weight, smoking cessation, diabetes~     control, high blood pressure control, dyslipidemia control).~      After 12 months we will evaluate the percentage of employees who accept to participate;~     prevalence of the cardiovascular risk factors and distribution according to the AHA~     classification in ideal, intermediate and poor; adherence to lifestyle change programs.~   "
76527|NCT02055638|"~     This study is designed to explore the safety and tolerability, and to compare the activity~     of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED).~      Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a~     two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria~     will be randomized to either SRX246 or Placebo treatment groups.~      Study subjects will be examined and asked to answer questionnaires at weekly scheduled~     visits throughout the trial. The study results will be determined based on any changes~     observed over the study period.~   "
76528|NCT02055625|"~     Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem~     cell transplantation (HSCT), and is classified as acute (aGVHD) or chronic (cGVHD). aGVHD~     onsets within the first 100 days after transplant or with clinical features including~     erythema, liver dysfunction and oral mucositis, whilst cGVHD or persistent GVHD occurs in~     approximately 30-60% of transplant patients who survive their first year . Long-term~     five-year prognosis for cGVHD patients is poor with a 70% mortality rate. cGVHD manifests as~     an autoimmune-like disease affecting multiple sites, including skin, mouth, eyes,~     gastrointestinal tract, liver, and joints. The oral cavity is the second most common site to~     be affected with symptoms in 45-83% of cases. In the mouth a diverse spectrum of clinical~     features can be found for example mucosal lesions can affect almost any site, salivary gland~     dysfunction and restricted mouth opening. Short-term patients can experience mucosal~     sensitivity, malnutrition, problems speaking, increased caries risk, xerostomia, oral pain~     and a diminished quality-of-life. Long-term complications include secondary malignancies and~     perhaps early death. Clinical management seeks to alleviate the symptoms and improve~     quality-of-life but 50% of patients fail front-line systemic steroid therapy. Oral cGVHD can~     be treated with topical high potency corticosteroids and oral rinses, however these~     treatments are not always effective and carry a risk of systemic absorption. Mesenchymal~     stem/stromal cells (MSCs) resident in adult and fetal tissues, such as the bone marrow have~     the capacity to form bone, cartilage, stroma, muscle and fat, are known to exhibit~     immunosuppressive and immunoregulatory properties both in vivo and in vitro. MSC infusions~     have been used to treat disorders such as osteogenic imperfecta, cardiovascular disease and~     to heal large bony defects. Indeed, the immunosuppressive capacity of MSCs have led to~     infusions being used as a second-line treatment for GVHD patients, and our group has shown~     within a Phase II clinical trial, 55% aGVHD patients who failed front-line steroid treatment~     responded to MSC infusion these studies are going with cGVHD patients. The goal of this~     project is to perform a pilot study to determine whether MSC injections directly into~     mucosal lesions in patients with oral cGVHD are able to alleviate the symptoms and~     facilitate the reparative process.~   "
76529|NCT02055612|"~     The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in~     Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet~     form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities~     etc.~   "
76530|NCT02055599|"~     The goal of this project to begin using a wound research database with clinical decision~     support features at Winthrop University Hospital. A research database is an electronic~     computer system that is used to collect patient information. Clinical decision support is~     the ability for a computer system to provide medical assistance to the doctor through alerts~     and recommendations based on the information entered. The investigators believe that use of~     a wound clinical decision support tool, much like a drug, will improve healing in patients~     with chronic wounds (wounds that fail to heal over the course of weeks) and ultimately lower~     the risk of death and illness caused by these wounds. In order to develop a useful clinical~     decision support tool, investigators first need to develop a large research database to~     determine the data points important for wound healing. The investigators will be using the~     data collected in this study for future research and publication. Data will be reviewed to~     answer questions important to wound healing and for the purpose of developing the clinical~     decision support alert system.~      After providing informed consent, participants will be asked a series of questions related~     to their past medical history, and relevant wound data will be collected. Study staff will~     photograph the wound at baseline, and once per week until the wound is completely healed, or~     for a duration of six months.~      Participants will be expected to return to Winthrop University Hospital for wound follow-up~     on a regular basis, or as determined by the Principal Investigator.~   "
76531|NCT02055586|"~     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission~     tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with~     metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic~     procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during~     treatment.~   "
76532|NCT02055573|"~     Regular reading with young children strengthens the parent-child relationship and builds~     their language, literacy and social emotional skills. Parent knowledge of normal variation~     of infant crying and of the dangers of shaking a baby as well as their ability to cope with~     infant irritability are likely factors in their successful adjustment to parenthood and the~     prevention of this tragic act.~      Purpose: Identify easily implementable interventions for economically disadvantaged mothers~     in the newborn period which 1) Promote early literacy behaviors and early nurturing~     parent-child relationships and 2) Increase mother's knowledge of normal crying patterns, the~     dangers of shaking a baby and her ability to cope with parenting stresses.~      Design/Methods: A convenience sample of 300 low income (insured by Medicaid) new mothers of~     healthy singleton, full term infants in the level 1 mother/baby unit at Women & Infants~     Hospital will be invited to participate in a Randomized Controlled Trial study of~     educational videos and materials for parents. They will be randomized into one of two~     intervention groups. 1) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and~     English and a bilingual booklet (both produced by Parents' action for Children) addressing~     the benefits of reading, talking and playing with young children, as well as a new~     children's board book. 2) The All Babies Cry (ABC) arm will receive a DVD in both, Spanish~     and English and a bilingual booklet (both produced by VIDA) explaining crying as part of~     normal infant behavior, highlighting signs of parental distress and providing strategies to~     sooth parents and their children. We will enroll 75 mothers who speak Spanish primarily at~     home in each intervention group, as well as 75 mothers who speak primarily English. The RTL~     mothers will serve as controls for the ABC mothers and vice versa. Before reviewing the~     materials, mothers will be asked to respond to a baseline interview with socio-demographic~     information, questions regarding Early Literacy promotion, reading with children and their~     own reading habits as well as general knowledge on the prevention of shaking a baby and~     handling their own stress. Follow up phone interviews will be conducted by a bilingual~     research assistant blind to the intervention status at 2-5 months post-partum containing~     similar questions. Consenting mothers will receive a bag of diapers at the completion of~     enrollment interview as an incentive for participating in the study. Data will be entered~     into Excel and transferred into STATA for analysis. Frequency counts will be generated for~     demographic, literacy related and parental knowledge and stress variables in the two~     intervention arms. Chi-Square and T-tests will be used to compare literacy and parental~     knowledge outcomes for each intervention group at both follow up interviews.~      Hypotheses: 1) Mothers in the RTL branch will recognize the importance of reading to their~     babies, initiating this activity at earlier ages and reading more often with them. 2)~     Mothers in the ABC branch will gain an understanding of crying as part of normal infant~     behavior and build strategies to sooth themselves and their newborns.~   "
76533|NCT02055560|"~     The primary objective of this study is to evaluate whether the management of colorectal~     cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU~     related toxicities and improves outcomes compared to the current standard of care. A~     secondary objective is to characterize the variability of 5-FU levels among CRC patients~     managed with 5-FU exposure optimization testing and the impact of such management on 5-FU~     plasma levels and drug doses during the course of chemotherapy.~   "
76534|NCT02055547|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     MK-8521. The primary hypothesis is that MK-8521 is sufficiently safe and well-tolerated in~     healthy, lean and obese males.~   "
76535|NCT02055534|"~     Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL)~     amyloidosis and has been associated with mortality and impaired quality of life (QoL). We~     investigated whether nutritional counseling is beneficial to the maintenance of nutritional~     status and QoL in AL outpatients.~   "
76536|NCT02055521|"~     Composite tissue allotransplants (CTA) involve transplantation of various tissues including~     vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The~     large majority of recipients have been maintained on immunosuppression therapy similar to~     that used in solid organ transplantation that is associated with the complications usually~     reported in solid organ transplantation. The question whether risks associated with~     indefinite immunosuppressive are justified for a non-lifesaving procedure still remains~     unanswered. At present no CTA recipient proved to be spontaneously tolerant with any~     immunosuppressive protocol; indeed, until now all recipients who discontinued the~     immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a~     low incidence of chronic rejection despite the high incidence of acute rejection episodes.~      For all these reasons it should be of great interest to minimize the immunosuppression in~     CTA patients knowing their immunologic risk. The main outcome of this study is to search~     for the signature of tolerance in recipients of hand or face allotransplantation testing~     biomarkers previously identified in operational tolerant kidney transplant recipients.~      These markers have been developed studying tolerant kidney recipients and they were already~     tested in five bilateral hand transplantations and one face transplantation.~      The present study will include hand and face allograft recipients transplanted at least one~     year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand~     transplantations, 4 single hand transplantations and 3 face transplantations. All the~     patients will undergo B cell phenotyping, TCR repertoire, molecular signature from~     operational tolerance and a skin biopsy with immunohistochemical staining of the specimens~     in order to show signs of acute or chronic rejection.~      The results could provide a valid tool to detect operationally tolerant recipients as well~     as recipients prone to develop chronic rejection.~   "
76548|NCT02055365|"~     Vaccines have been responsible for preventing millions of deaths and extending the average~     human lifespan. Effective vaccines stimulate the cells of the immune system to activate~     genes and associated functions that bring about protective immunity.This study aims to~     define cellular functions and genes important for the hepatitis B (HBV) vaccine immune~     response in healthy individuals. The investigators hypothesize that many genes associated~     with innate and adaptive immune functions are important for an effective HBV vaccine~     response.~   "
76549|NCT02055352|"~     To demonstrate the free combination of budesonide and indacaterol is as efficacious as~     fluticasone and salmeterol in patients with COPD~   "
76537|NCT02055508|"~     The investigators plan to evaluate, in a randomized, controlled phase III trial in patients~     with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise~     intervention program (EIP) on quality of life, physical functioning and immune function~     parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases,~     Heidelberg, over a time period of two years and followed up for a total of 12 months.~      Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus~     CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential~     influence of social contacts that can be anticipated for the patients in the intervention~     group).~      Our primary aims are to investigate whether a combination of a partly supervised (in- and~     outpatient) and partly home-based endurance and resistance training improves quality of life~     (QoL) and lowers levels of fatigue (evaluation via the standardized and validated~     questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on~     tumor specific immune responses. Biomarkers of immune function will be measured by cellular~     immunity and cytokine and chemokine panels.~      Further secondary outcomes include measurement of anxiety, depression and demoralization,~     physical performance parameters (e.g. improvement in walk distance, muscle strength), as~     well as overall and progression free survival analyses.~      The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in~     patients with advanced NSCLC with the results being utilized in the design of the here~     proposed trial.~      The investigators hypothesize that patients randomized in the exercise intervention group~     will show improved QoL and reduced fatigue, as well as improved physical functioning and~     increased tumor specific immune responses.~   "
76538|NCT02055495|"~     There is no consensus on the surgical treatment of unremitting, painful flatfeet in~     children. Subtalar arthroereisis has gained notoriety although there is a paucity of~     literature on its biomechanical effects. The goal of the investigators was to compare a~     group treated with subtalar arthroereisis with another group undergoing lateral column~     calcaneal lengthening. The investigators hypothesis was that the results of arthroereisis~     would be equivalent to the more established method of calcaneal lengthening.~   "
76539|NCT02055482|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is~     a general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this extension study is to find out if the study drug, a tablet taken orally,~     is safe and effective for the treatment of anaemia associated with chronic kidney disease.~      The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and~     Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part~     in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and~     the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16~     weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with~     visits every 4 weeks. During these scheduled visits patients will undergo a number of~     procedures to confirm efficacy and safety of the study drug, including measurement of heart~     rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample~     collection for laboratory tests.~      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this~     research. This study will include subjects who either completed the treatment period in~     their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a~     stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a~     double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to~     entry into the extension study.~   "
76540|NCT02055469|"~     In patients with achalasia, the relationship between the perception of dysphagia,~     oesophageal emptying, lower oesophageal sphincter (LOS) distensibility and oesophageal~     circular and longitudinal muscle contraction is not clear.~      We aim to characterize oesophageal circumferential and longitudinal muscle contractility and~     LOS distensibility in patients with achalasia (either before or after treatment). This may~     allow an understanding of the mechanisms underlying persistent dysphagia and delayed~     oesophageal emptying after treatment.~   "
76541|NCT02055456|"~     Decrease in blood cell counts due to deficient bone marrow function, called bone marrow~     failure, as well as some lung diseases, called idiopathic pulmonary fibrosis, can be caused~     by genetic defects in telomere biology genes, eventually causing telomere erosion. These~     disorders are collectively termed telomeropathies.~      There is evidence that male hormones may improve blood cell counts in marrow failure, and~     these hormones are able to stimulate telomerase function in hematopoietic cells in vitro. We~     propose this study to the use of male hormone in patients with aplastic anemia and pulmonary~     fibrosis associated with defects in telomeres.~   "
76542|NCT02055443|"~     The purpose of this study is to evaluate whether new novel markers from the clinical~     electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can~     detect coronary artery disease in patients with chest pain. The researchers are especially~     interested in studying how changes in these unique waves evolve over time with rest and~     activity. It is hoped that the findings will be helpful in differentiating patients with~     cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early~     identification can accelerate treatment and save lives.~      Eligible participants are those age 18 and older who have been referred for a nuclear stress~     test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary~     artery disease as part of their clinical care.~   "
76543|NCT02055430|"~     To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary~     drainage in children~   "
76544|NCT02055417|"~     In this 3-year study, the investigators will develop and pilot test an intervention called~     Personal Approaches to Treatment Choices for HIV (PATCH). PATCH is a brief intervention~     designed to support participants' decision-making processes and enhance intrinsic motivation~     to initiate ART, using motivational interviewing (MI) techniques. The intervention will be~     targeted at HIV-positive African-American adults in inner-city Baltimore, Maryland who are~     suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness~     to begin ART. The specific aims are: (1) Develop and refine a manual for a brief MI~     intervention to support ART decision-making and reduce the likelihood of ART refusal: (2)~     Evaluate the feasibility and acceptability of implementing the PATCH intervention in a small~     sample of individuals who are African-American, recommended for ART but who are not current~     taking it, and who experience multiple barriers to ART adherence; and (3) Conduct a small~     randomized controlled pilot to test the potential efficacy of the PATCH intervention in~     producing positive attitudinal changes, including a reduction in conspiracy beliefs and~     perceived barriers to ART and stated readiness to begin ART.~   "
76545|NCT02055404|"~     The purpose of this study was to select the size of the molded rotation mark for a new toric~     contact lens by comparing the visibility of various molded rotation marks.~   "
76546|NCT02055391|"~     The purpose of this study is to determine whether a new weight loss treatment which~     incorporates behavioral weight loss skills and skills for learning how to identify, manage,~     and cope with emotions helps with weight loss and emotional eating in people who are~     overweight and eat in response to emotions.~   "
76550|NCT02055339|"~     Preterm infants born before 28 weeks gestation are at risk for lung disease and require~     oxygen and pressure to keep their lungs open. This usually involves a device called nasal~     continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they~     are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not~     started due to concerns for choking. This may cause them to miss their window of learning~     and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from~     nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide~     enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is~     another mode of providing oxygen and pressure. It is equal to nCPAP in small babies~     transitioning off of ventilators, but no studies have been done in older babies. We plan to~     compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm~     babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The~     goal will be the fastest time to full oral feeds.~   "
76551|NCT02055326|"~     The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a~     quit-smoking program that combines behavioral therapy with either yoga, or a health &~     wellness program that serves as a contact control.~   "
76552|NCT02055313|"~     The main objective of this study is to explore experiences and insights from exceptional~     patients, patients with cancer that were considered by their physicians as having~     exceptional course of survival related to their specific disease state.~      A secondary future objective of this study is to develop an international multicenter~     registry and database documenting and examining the experience of patients with cancer that~     were considered by their physicians as having exceptional course of survival related to~     their specific disease state.~   "
76553|NCT02055300|"~     The purpose of this study is to evaluate the safety and tolerability of escalating single~     oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of~     escalating single oral doses of LY03005.~   "
76554|NCT02055287|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following~     an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate~     the safety and tolerability and preliminary efficacy of LY03004 following intramuscular~     injection.~   "
76555|NCT02055274|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following~     multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate~     the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of~     LY03003 following intramuscular injections.~   "
76556|NCT02055261|"~     The appearance of postural instability and gait disorders is a major turning point in the~     evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to~     L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced~     outside mobility. There is no effective pharmacological treatment available for these~     symptoms, and their pathophysiology is not well known : it is currently assumed that~     non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these~     patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic~     nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to~     L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the~     origin of these axial symptoms, since the PPN participates in the maintenance of posture and~     motion in primates. In PD patients, recent reports have suggested that low frequency~     stimulation of the PPN may equally improve gait and posture. However, these results are~     debatable due to methodological limitations, insufficient clinical evaluation and uncertain~     anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six~     advanced PD patients according to the usual criteria for STN DBS who are, however,~     unsuitable for this operation due to gait and posture disorders. We will perform a~     randomized, double-blind and cross over design (two months periods with and without DBS~     randomly assigned to each patient). The targeting will be allowed by a a three-dimensional~     and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance~     imaging (MRI) of each patient. Evaluations will comprise 1 month before surgery and in Off~     and On stimulation condition:~        -  clinical motor assessment in both Off and On drug state, including cardinal~          parkinsonian signs, gait and balance~        -  gait initiation physiological evaluation~        -  cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN~          stimulation may well represent a substantial improvement of our therapeutic options for~          advanced PD patients suffering from debilitating gait and posture disorders~          unresponsive to L-Dopa.~   "
76557|NCT02055248|"~     Background:~      - Moebius syndrome limits the ability to make facial expressions like smile, frown or blink~     - and move the eyes laterally. It can also cause speech, swallowing or breathing~     difficulties and affect parts of the body, such as the limbs, jaw, muscles, or the heart.~     Some individuals with Moebius can have intellectual impairment or behavior problems.~     Researchers want to study the clinical features of individuals with Moebius or related~     disorders and explore the genetic and/or environmental causes of these conditions.~      Objective:~      - To learn more about the genetics and clinical characteristics of Moebius syndrome and~     other Congenital Facial Weakness disorders.~      Eligibility:~      - People ages 2 to 80 years with congenital facial weakness, isolated or combined with other~     congenital anomalies, and their family members.~      Design:~        -  Participants with Moebius syndrome or other congenital facial weakness disorder will be~          evaluated at the NIH Clinical Research Center over 3 to 5 days and undergo the~          following procedures:~        -  Medical and family history and physical examination, including body measurements and~          vital signs.~        -  Blood or saliva will be collected for genetic tests and to evaluate liver, kidney,~          heart and hormonal~      functions.~        -  Eye examination, including having a video taken of their eyes moving.~        -  Hearing evaluation.~        -  Speech and language assessment, including swallowing studies.~        -  Dental exam.~        -  Detailed neurological evaluation, including electromyogram/nerve conduction and blink~          reflex study.~        -  Rehabilitation medicine evaluation, including muscle and tongue strength testing and~          assessment of balance.~        -  Neurocognitive and behavioral testing and questionnaires to assess quality of life and~          copying mechanisms.~        -  Imaging studies of their head, by magnetic resonance and diffusion tensor imaging~          -MRI/DTI. Participants~      will lie on a table that slides into a metal cylinder that takes images of internal body~     structures using~      magnets. Child participants may be sedated.~        -  Some adults may have additional X-rays of their head or limbs, if there are abnormal~          findings.~        -  Medical photographs of the face and affected body parts may be taken.~        -  Other specialized tests or consultations, as indicated.~        -  Participants can choose to have a skin biopsy taken.~        -  A follow-up visit will be offered to participants for review of genetic test findings~          and possibly additional clinical tests, as indicated.~      Family members of the patients will have a medical and family history and physical~     examination. Blood or saliva will be obtained for genetic studies.~   "
76569|NCT02055092|"~     People diagnosed with young onset dementia are today mostly assigned to the same healthcare~     services as people developing dementia at an older age. They and their families are however~     in a quite different life situation, which is likely to generate different challenges and~     specific needs for tailored healthcare services, of importance in maintaining their~     perceived quality of life.~      The investigators of this study wish to assess the factors influencing these families'~     quality of life, their specific needs and their use of healthcare services by the use a~     combination of quantitative and qualitative methods. The main aim of this study is to~     provide better future healthcare services to these families, and to develop a programme for~     optimal collaboration between specialist healthcare services and the local dementia teams.~   "
76591|NCT02054806|"~     This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to~     participants with incurable advanced biomarker-positive solid tumors that have not responded~     to current therapy or for which current therapy is not appropriate.~      The study hypothesis is that administration of pembrolizumab to participants with some types~     of solid tumors will result in a clinically meaningful response rate.~   "
76558|NCT02055235|"~     Background:~      - Different people perceive the same pain differently. Mood, attention, stress, and~     personality affect how we feel pain. Researchers want to know whether people who do yoga~     perceive pain differently than people who do not practice yoga, meditation, or martial arts.~     They also want to study if cortisol, a stress hormone, relates to pain or brain differences.~      Objective:~      - To study the effects of yoga on the body s stress response, pain perception, and the brain~     s structure and pain response.~      Eligibility:~        -  Right-handed adults 30 years and older who practice yoga regularly.~        -  Healthy right-handed volunteers 30 years and older who do at least mild exercise but no~          yoga or martial arts.~      Design:~        -  Visit 1: Participants will be screened with medical history and physical exam. They~          will have blood and urine tests and electrocardiogram to measure heart activity.~        -  At home, participants will wear a heart monitor for 1 day and collect 5 saliva samples~          daily for seven days.~        -  Visit 2: Participants will undergo tests in a chair or in a mock MRI machine. They will~          lie on a table that slides into a cylinder.~        -  A heating device will be placed on their leg and heated periodically for few seconds at~          a time.~        -  They will give saliva samples.~        -  Heart rate, respiration, etc. will be monitored.~        -  They will fill out questionnaires.~        -  Visit 3: Participants will answer questions and repeat Visit 2 tests. Tests will be~          done in the real MRI machine. The scanner makes loud knocking sounds. Participants will~          get earplugs. Participants will be in the scanner about 1 hour with a coil over their~          head.~   "
76559|NCT02055222|"~     Despite the implementation of modern public health interventions, 1 in 5 adults in the~     United States are either current or former smokers and remain at risk for the development of~     chronic lung diseases. It is unknown how or why any one individual smoker can develop a wide~     range of lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis.~     The purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar~     samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles~     that correspond to divergent pathways in the expression of such proteins as the transforming~     growth factor-beta1 (TGF- <=1). The information generated from this study will provide~     insight into the pathogenesis of smoking-related lung injury and potentially allow for the~     development of early therapeutic interventions....~   "
76560|NCT02055209|"~     Our objective is to develop a community-based cohort and novel genomic science resource for~     defining the biological significance of ancestry-related genomic variation in~     African-Americans within the GENE-FORECAST :GENomics, Environmental FactORs and the Social~     DEterminants of Cardiovascular Disease in African Americans STudy. This resource will enable~     our team to test the working hypothesis that race-ancestry differences in the burden of~     cardiovascular disease (CVD) reflects the influence of a unique interplay between the~     distinct genomic variation characteristic of African-Americans (AA) and the exposome of~     social determinants and environmental factors that influence the pathogenesis of CVD in AA.~     The specific aims are:~      AIM I. To examine the associations between common or ancestry-related DNA variants and CVD~     risk factors (e.g. hypertension) and phenotypes (e.g. coronary artery calcification) in~     African-Americans (AA).~      AIM II. To examine the associations between health behaviors or social-environmental factors~     and CVD risk factors and phenotypes in AA.~      The study is designed to create a cohort amenable to nested case-control analyses based on a~     community-based sampling frame with a target size of approximately 1800 self-identified, US~     -born, African-American (AA) men and women (ages 21-65) to be recruited over the next 5-6~     years from the metropolitan Washington DC, Montgomery County (MC) and Prince George s County~     (PG) areas to be recruited to the NIH Clinical Center. The initial participant recruitment~     strategy involved two approaches: 1) a random-digit telephone screening survey targeting~     study-eligible AA that will be consented and invited to an evaluation visit in the NIH~     Clinical Center which we contracted with a well-established survey group (Southern Research~     Group [SRG]); and 2) a community outreach effort to recruit participants into the Clinical~     Center by leveraging marketing and the engagement of community-based leaders, organizations~     and faith-based institutions in the area. We are no longer contracting with SRG but rather~     focusing on community outreach and marketing for recruitment to the Clinical Center. The~     contract with SRG was terminated after the first two years of the protocol due to low yield~     of recruitment to the Clinical Center compared to community outreach.~      Given the high burden of CVD among AA, this approach will yield a sample with normal~     individuals as well as a high proportion of AA with CVD risk factors such as obesity and~     hypertension that predispose to the eventual clinical signs and symptoms of CVD (e.g. heart~     attack and stroke). Based on previous epidemiology studies, this protocol s participant~     ascertainment approach and the target demographic profile; it is anticipated that the~     prevalence of clinically manifest CVD (history of angina, heart attack or stroke) will be~     less than 10-15% of the sample. All participants will undergo extensive evaluation in the~     Clinical Center that includes: medical evaluation (e.g. anthropometrics, blood pressure),~     laboratory tests (e.g. lipid levels, kidney function), social determinants profiles (e.g.~     socioeconomic status (SES), perceived stress, discrimination, depression, perceived~     neighborhood characteristics), blood/urine collection for deep-sequencing based omic~     analyses (e.g. whole exome sequencing, and RNA-Seq), as well as testing for pre-clinical ,~     biomarkers of the pathobiological processes of CVD or CVD phenotypes (e.g. coronary artery~     calcification, microalbuminuria, leukocyte telomeres, or vascular dysfunction). It is~     anticipated that these deep sequencing efforts will yield novel ancestry-related DNA~     variants associated with the CVD phenotypes; yet with unclear biological significance in~     elucidating racial disparities in CVD. Accordingly, our protocol also includes a~     Genotype-to-Phenotype (G2P) component that re- contacts subsets of the cohort based on their~     genotype (e.g. APOL1 chronic kidney disease risk alleles) for a call-back visit for more~     in-depth phenotyping and characterization of the potential effect of the DNA variant of~     interest on human systems biology. In some cases family members of the proband may also be~     invited to participate in these G2P studies to further characterize the biological~     significance of these putative functional DNA variants of interest.~      The primary outcome variables involve well established CVD phenotypes: 1) CVD risk factors~     (e.g. hypertension, dyslipidemia), 2) markers of pre-clinical CVD (i.e. coronary artery~     calcification, coronary plaque burden by cardiac CT angiography (CTA), carotid plaque burden~     by 3D ultrasound, vascular dysfunction, microalbuminuria, C-reactive protein, Vitamin D~     levels). The protocol will assess exposures associated with CVD and relevant covariates~     including: 1) social determinants (e.g. socioeconomic status (SES), perceived stress,~     discrimination, and depression); 2) environmental factors s......~   "
76561|NCT02055196|"~     This phase I trial studies the side effects and best dose of genetically modified stem cells~     when given together with irinotecan hydrochloride in treating patients with recurrent~     high-grade gliomas. Irinotecan hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Placing a gene that has been created in the~     laboratory into neural stem cells and injecting it into the brain may help irinotecan~     hydrochloride kill more tumor cells once it reaches the brain.~   "
76562|NCT02055183|"~     The purpose of the Registry will be to evaluate patient safety following Botulism Antitoxin~     Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric~     patients with a confirmed or suspected exposure to botulinum toxin. This Registry is~     intended to serve as an active surveillance system to further assess the safety profile for~     BAT® and to quantify the occurrence of unexpected adverse events, given that the current~     safety database is considered too small to reliably identify unexpected risks.~   "
76563|NCT02055170|"~     The purpose of this study is to study the effect of hormone therapies (androgen pathway~     modification) on the outcomes of patients with lung cancer. This information may be of~     benefit for future treatment strategies, prevention and control.~      In this study, the protein where testosterone binds, called the androgen receptor (AR), will~     be measured in samples from the patient's biopsy and surgical tumor samples. The~     investigators will look at a marker of how fast the cancer is growing (Ki67) before using~     finasteride from your biopsy specimen. Finasteride will be taken from the day of consent~     until the day of the patient's surgery. This marker will be measured again after using~     finasteride from the surgical specimen. The investigators will be looking for a decrease in~     the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that~     this medication is blocking tumour growth.~   "
76564|NCT02055157|"~     This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in~     children with achondroplasia. The primary objective is to assess the safety and tolerability~     of daily BMN 111 administered to children with achondroplasia.~   "
76565|NCT02055144|"~     VeriStrat® is a pretreatment blood-based test correlated with clinical outcome after~     EGFR-TKI therapy in non-small cell lung cancer (NSCLC) patients.~      The investigators hypothesis is that VeriStrat could be also employed as a biomarker of~     benefit from treatment with standard chemotherapy regimens in first line NSCLC patients.~   "
76566|NCT02055131|"~     This is a prospective study consisting in testing whether systematic use of aspirin is~     beneficial for primary prevention of vascular access for hemodialysis attested by doppler~     ultrasound exam. The investigators will study aspirin resistance in the population of~     patients undergoing hemodialysis. The investigators will test sensibility of resistant~     patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to~     define aspirin resistance.~   "
76567|NCT02055118|"~     Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical~     parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg~     for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have~     previously received and tolerated a minimum of 4 months of therapy with Elaprase.~   "
76568|NCT02055105|"~     The goal of this study is to demonstrate the sensitivity and specificity of detecting~     circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow~     expression and modulation of levels in response to therapy in comparison to current~     biomarkers.~   "
76589|NCT02054832|"~     The aim of the present study is to determine if there is a change in quality and quantity of~     sleep perceived by adults and children with GSD and their parents while starting a modified~     UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate~     if there is a change in quality of life perceived by adults and children and their parents~     with Glycosade.~   "
76590|NCT02054819|"~     It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease~     can benefit from curative therapy and extends beyond the very limited subset of~     oligometastatic patients that have already been studied.~   "
76570|NCT02055079|"~     Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density~     and general tubular cell proliferation in animal models, and to a reduction of the increase~     in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a~     reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney~     enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density~     in the renal cortex in humans.~      However, despite promising data from animal- and in vivo studies, most mammalian target of~     rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney~     disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and~     the preservation of renal function.~      In this study we will investigate if pulsed administration of SIR in a fixed weekly oral~     dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and~     preserves excretory renal function in patients with ADPKD and an estimated glomerular~     filtration (eGFR) rate below 60 mL/min per 1.73m2.~   "
76571|NCT02055066|"~     This a first-in-human study of an antibody blocking the function of the oncogene c-met in~     patients with cancer.~   "
76572|NCT02055053|"~     To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia~     repair on post-operative pain.~   "
76573|NCT02055040|"~     This research study is a clinical trial. Clinical trials test the effectiveness of an~     investigational imaging technique to learn whether the investigational imaging technique~     works in detecting cardiac injury after the administration of certain chemotherapies, such~     as doxorubicin. Investigational means that the imaging technique is still being studied~     and that research doctors are trying to find out more about it-such as whether the technique~     can detect lower levels of cardiac injury after treatment with doxorubicin. It also means~     that the FDA has not yet approved the use of gadolinium or approved the use of CMR studies~     for detection of cardiac toxicity after doxorubicin.~      The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been~     associated with the development of heart failure in some patients.~      Cardiac Magnetic Resonance (CMR) is a type of MRI scan that uses a magnetic field to produce~     pictures of the heart. The CMR scan has been used in other studies and information from~     those other research studies suggest that this imaging technique may help to better detect~     differences in the structure of the heart muscle after treatment with doxorubicin.~      In this research study, the investigators hope that they can better detect changes in the~     heart muscle before and after treatment with doxorubicin with the CMR scan in hopes that~     cardiac injury can be detected and treated earlier to prevent heart failure.~   "
76574|NCT02055027|"~     Prospective study designed to identify factors that would predict patient adherence to CPAP~     (Continuous Positive Airway Pressure) therapy.~   "
76575|NCT02055014|"~     New effective non-surgical treatments are needed for patients whose obesity and type 2~     diabetes (T2DM) do not respond to current medical therapies. We propose a randomised~     controlled trial of Endobarrier, an implantable intestinal device that separates ingested~     food from contacting the first 60cm of intestine where sited and that mimics some of the~     clinical effects of bariatric surgery (improved metabolic control with weight loss) with or~     without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs~     Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal~     glycaemic control despite current conventional diabetes treatment, in an NHS setting.~      Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous~     GLP-1RA therapy will be studied over 24 months and randomised to receive Endobarrier with~     continued Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide~     1.8mg without Endobarrier.~      We will investigate potential mechanisms of action and their time course as part of the~     study by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2.~     energy intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation~     and permeability measures.~      The data will inform clinical use of the device and development of new treatments for T2DM~     and obesity.~   "
76576|NCT02055001|"~     Atherothrombotic disorders account for 25% of all deaths among women and for substantial~     morbidity and resource use in health care. Nonetheless, gender-related differences in the~     epidemiology of cardiovascular disease (CVD) remain largely unexplained. Among mechanisms~     that could account for such differences, the biology of platelets, which exert a pivotal~     pathogenetic role in atherothrombosis, and of coagulation system are on investigation.~      Thus, differences in platelet reactivity between women and men have been described using~     several methods and in response to varying stimuli. Indeed, sex steroid hormones could be~     involved in a different response of platelet to physiological response to agonists. The~     finding that estrogen receptors are expressed in platelets makes these cells an excellent~     model for studying the non-genomic effects of steroid hormones. Also coagulation cascade has~     been reported to be influenced by sexual endogenous as well as exogeneous hormones (i.e~     contraceptives) In particular, the impact of endogenous estrogens (menstrual cycle) on~     platelet activity and on response to antiplatelets drugs in fertile women has never been~     evaluated.~      Accordingly, the goal of this proposal is to investigate relationship between platelet~     function (assessed by aggregometry tests and markers of platelet activation in vivo such as~     thromboxane production, CD40L and P- selectin levels) and sex hormones during physiological~     regular menstrual cycles (28-30 days) in healthy pre-menopausal women aged from 18 to 40~     years. Moreover, in a subgroup of healthy women free from antiplatelet drugs, will be~     planned a proof of concept study to investigate if there will be variations, during a short~     term (1 month) low dose aspirin, in platelet reactivity according to the different phases of~     menstrual cycle in 10 healthy premenopausal women aged from 18 to 40 years. Moreover, it~     will be investigate effect of steroid hormonal pattern on residual platelet activity~     response on treatment~   "
76577|NCT02054988|"~     Prasugrel is a potent thienopyridine antiplatelet agent that selectively and irreversibly~     inhibits ADP-induced platelet aggregation mediated by the P2Y12 receptor. Prasugrel is a~     prodrug that must first undergo biotransformation to its active metabolite via cytochrome~     P450-mediated hepatic metabolism (CYP1A2). Clopidogrel is currently administered to several~     million patients especially after coronary stenting. Clopidogrel has been shown to reduce~     cardiovascular complications in patients with acute coronary syndromes and patients who have~     undergone coronary stenting. The mechanism of action of clopidogrel's active metabolite~     involves inhibition of the purinergic adenosine diphosphate (ADP) receptor P2Y12 on the~     platelet membrane. Blockade of this receptor prevents uncoupling of the associated Gi2~     protein which ultimately leads to increased platelet cyclic AMP (cAMP) formation.3 Cyclic~     AMP is a key signaling molecule in inhibiting platelet aggregation, but its intracellular~     levels are affected by several other commonly used compounds. For instance, methylxanthines,~     such as caffeine, theophylline, and theobromine (an ingredient of chocolate), all cause~     elevation of intracellular cAMP levels by inhibiting adenosine receptors (types A1 and A2)~     on the platelet membrane. The effect of caffeine consumption on platelet reactivity depends~     on the caffeine dose and duration of administration. Chronic caffeine consumption (≥7 days)~     appears to be associated with inhibition of platelet aggregation, probably through~     upregulation of adenosine receptors.The aim of this study was to examine the effect of acute~     caffeine consumption, at a dose equivalent to commercial coffee drinks, on the antiplatelet~     effect of clopidogrel and prasugrel, in patients with coronary artery disease (CAD).~      Platelet function will be evaluated using a validated method: the VerifyNow System~     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical~     detection system that measures platelet-induced aggregation.~   "
78042|NCT02035917|"~     this study will perform to compare the results and functional outcomes of tibial plateau~     fractures treated with non-locking and locking plate fixation.~   "
76578|NCT02054975|"~     This is a pilot randomized controlled trial of lower vs. higher dose vitamin D~     supplementation in D-deficient asthmatic children, to determine necessary sample sizes for~     outcome measures in a larger multisite study, and to examine possible relationships and~     effect sizes between various biological markers that may be important to the pathophysiology~     of childhood asthma.~      Aims of the study are to:~        1. Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid~          (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D,~          on immune function, and asthma severity.~        2. Characterize changes in innate and adaptive immune function and inflammatory responses~          in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary~          O6:O3FA status and vitD dose.~   "
76579|NCT02054962|"~     Chronic problems after traumatic events are common in non-elderly adults. Previous studies~     have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult~     patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of~     non-elderly adults will develop psychological sequelae, including posttraumatic stress~     disorder, depression, and anxiety disorders. There have been no prospective studies~     examining the frequency or predictors of persistent pain or psychological sequelae in older~     adults. The proposed study seeks to determine the frequency of persistent pain,~     psychological sequelae, and associated disability in older adults after minor MVC trauma and~     to identify candidate predictors for a model of adverse outcomes after MVC in this~     population. 200 individuals over 65 years of age will be recruited from emergency~     departments in four states with no-fault accident laws. Patients who meet inclusion criteria~     and who consent to the ED study will undergo a 30-45 minute ED assessment of crash-related,~     psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks~     6 months, and 12 months. The wealth of information gained from this study will be used to~     determine the frequency of adverse events in older adults after MVC and to identify high~     risk elderly patients. These results will inform subsequent development of secondary~     pharmacologic and/or behavioral interventions to prevent chronic pain and psychological~     sequelae after traumatic events in older adults.~   "
76580|NCT02054949|"~     This is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine~     (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid~     epilepsy whose seizures are not responding well to usual medical treatment. The study is~     also looking to see if this supplement is helpful for immediate and ongoing treatment of~     symptoms of irritability. Additionally, this study will also look to see if certain~     substances in the blood that measure a specific type of stress on cells in the body can help~     tell us how NAC may be helping.~   "
76581|NCT02054936|"~     To compare side effects and complications relating to use of warfarin or rivaroxaban,~     tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively,~     extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub~     and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two~     randomized groups. Return visits to the operating room, length of stay, and VTE rates will~     also be compared.~   "
76582|NCT02054923|"~     Routine video recording of the colonoscopy examination has been proposed as a simple and~     easy to implement method that could improve the quality of colonoscopy. The purpose of this~     study is to investigate whether implementation of routine video recording of screening~     colonoscopy withdrawal is effective as a means of supporting quality performance of~     colonoscopy. The study will be performed in 8 screening centers within the framework of a~     national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform;~     PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in~     period colonoscopy quality measures will be monitored through a dedicated joint database.~     Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video~     recording group or the control group. Screening centres assigned to the video recording~     group will receive videorecorders and DVDs and will be asked to video record all screening~     colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on~     demand only. Then , the colonoscopy quality measures will again be monitored through a~     dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation~     and withdrawal time by the PCSP team.~   "
76583|NCT02054910|"~     This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus~     Block (CPB) treatment in comparison to EUS without a pain block administered. All~     participants will receive medications for pain as needed.~   "
76584|NCT02054897|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and~     safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2~     diabetes. (SUSTAIN™ 1-Monotherapy).~   "
76585|NCT02054884|"~     There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have~     been conducted to establish standard of care. Despite a sizable number of objective~     responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall~     survival has never been demonstrated.~      This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in~     combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic~     efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who~     are not amenable to surgery.~      A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the~     study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A),~     and 45 patients will receive paclitaxel monotherapy (Arm B).~   "
76586|NCT02054871|"~     This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal~     protection in patients undergoing peripheral angioplasty. Patients will be randomised to~     receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if~     any protective benefit was obtained.~   "
76587|NCT02054858|"~     This study aims to assess if applying an ischaemic insult to an arm before giving~     intravenous contrast will help decrease the incidence of developing contrast induced acute~     renal injury in patients undergoing contrast-enhanced CT Scans.~      The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans,~     does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and~     reperfusion, when compared to control, reduce the proportion of patients developing~     contrast-induced acute kidney injury in the first 3 post-scan days? '.~   "
76588|NCT02054845|"~     Approximately 60% of the patients with Parkinson's Disease (PD) that receive Levodopa~     therapy eventually develop response fluctuations in motor symptoms, such as rigidity,~     freezing and akinesia. Patients experience an 'off'-period just before the next dose of~     dopaminergic medication is needed, called the 'wearing-off'-phenomena. Wearing-off is also~     accompanied by non-motor symptoms such as depression, anxiety, pain and thinking disability.~     Together, these motor and non-motor symptoms have a major impact on the quality of life of~     patients and their partner or caregiver.~      Patients with wearing-off often experience severe anxiety and panic symptoms that are~     incongruent with the severity of the motor symptoms during an 'off' period. These symptoms~     include stress, dizziness, pounding/racing of the heart, dyspnoea and hyperventilation. This~     type of anxiety is called wearing-off related anxiety (WRA) and might be a consequence of~     the hypersensitivity towards somatic manifestations and effects of a wearing-off period.~     This bodily misperception can have major consequences for the patient's feelings and~     behaviour. The experienced anxiety is often not consciously linked to the wearing-off and is~     therefore not well recognized by neurologists.~      Treatment as usual in response fluctuations is physiotherapy, consisting of physical~     exercises for mobility problems, freezing, dyskinesias, etc. This kind of training hardly~     touches upon the mental aspects and the role of anxiety as integral element of the response~     fluctuations. Cognitive behaviour therapy (CBT, including exposure in vivo) is sometimes~     used to treat WRA, but seems to have unsatisfactory results since the changed body awareness~     is not sufficiently addressed. Also, the methods used in cognitive therapies focus on the~     elimination of WRA which is often not realistic since wearing-off symptoms will remain or~     even increase during disease progression. As of yet, there are no known alternative~     intervention options. This study focuses on a new intervention by integrating elements from~     physiotherapy, mindfulness, CBT (mainly exposure), Acceptance and Commitment Therapy (ACT)~     and psycho-education.~      Objective: The current proposal aims at investigating the effect of a multidisciplinary~     non-verbal intervention on the awareness and modulation of WRA to improve self-efficacy,~     mobility, mood, and quality of life as compared to usual care.~      Study design: Randomized controlled clinical trial.~      Study population: Thirty-six PD patients who experience WRA.~      Intervention: Patients with PD are randomly allocated into one of two groups (n= 18 each).~     One group receives the experimental 'body-awareness therapy', while the second group~     receives regular group-physiotherapy (treatment as usual). Both interventions will take 6~     weeks in which 2 sessions per week with a duration of 1,5 hour will be performed.~      Main study parameters/endpoints: The General Self-Efficacy Scale is the primary outcome~     measure and will be assessed prior to, directly after and 18 weeks after the intervention.~   "
76592|NCT02054793|"~     This research is being done to test the safety and anti-cancer activity of the combination~     of an investigational drug called orteronel, with a drug called itraconazole in the~     treatment of castration-resistant prostate cancer.~      Orteronel is an investigational drug known as a 17,20-lyase enzyme inhibitor, meaning that~     it blocks the formation of male sex hormones.~      Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of~     various fungal infections such as fingernail/toenail infections and other more serious~     fungal infections. While it has shown evidence of activity against prostate cancer in prior~     studies, it is not approved for use in cancer. The FDA is allowing the use of orteronel and~     itraconazole in this research study. In addition to its antifungal properties, itraconazole~     was discovered to function to block angiogenesis (blood vessel formation to tumors) to block~     a cellular pathway thought to be important in prostate cancer known as the Hedgehog pathway.~      Investigators hypothesize that blocking male sex hormone production with orteronel will~     increase reliance on the Hedgehog pathway in prostate cancer cells which can then be blocked~     with itraconazole and that the combination of these two drugs will be more effective than~     either alone.~   "
76593|NCT02054780|"~     The purpose of this study is to compare the effectiveness of two types of counseling,~     Psychosocial Counseling and Trauma-Focused Cognitive Behavioral Therapy, in addressing~     outcomes of orphans and vulnerable children including mental and behavioral health,~     well-being, social support, and HIV risk behaviors. The study will be conducted in Lusaka,~     Zambia.~   "
76594|NCT02054767|"~     The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and~     mepivacaine in patients with irreversible pulpitis of mandibular molar.~   "
76595|NCT02054754|"~     The purpose of this study is to test the safety and observe the pharmacokinetics~     (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy~     male subjects following a single oral dose.~   "
76596|NCT02054741|"~     This cluster randomized clinical trial compares a geriatric assessment intervention with~     usual care for reducing cancer treatment toxicity in older patients with cancer that has~     spread to other places in the body. A geriatric assessment may identify risk factors for~     cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.~   "
76597|NCT02054728|"~     The purpose of this study is to assess hemodynamic effects of inspiratory muscle training~     during routinely performed right-heart catheterization.~   "
76598|NCT02054715|"~     This randomized clinical trial compares multimedia psychoeducation to print education in~     preparing patients with cancer for decision making about clinical trial participation.~     Multimedia psychoeducation includes a DVD and written materials with a combined focus on~     knowledge and attitude change, and may be an effective method to help patients prepare for~     decision making about clinical trial participation. It is not yet known whether a multimedia~     psychoeducation is more effective than print education in preparing patients for decision~     making about clinical trials.~   "
76599|NCT02054702|"~     The purpose of this study is to explore changes in efficacy, cognitive functioning, and~     safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia~   "
76600|NCT02054689|"~     This is a research trial that seeks to break up the total radiation dose into multiple~     smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may~     make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and~     possible costs will be described later in this document. This clinical trial is for people~     who have had no prior whole brain radiation.~   "
76601|NCT02054676|"~     The purpose of this study is to evaluate validation and clinical assessment of the earlier~     proposed clinical and radiological classification of the jawbone anatomy in endosseous~     dental implant treatment.~      Expected results.~        -  high accuracy of proposed classification for proper implantation risk degree~          evaluation.~        -  the proposed classification system based on anatomical and radiological jawbone~          quantity and quality evaluation will be a helpful tool for planning of treatment~          strategy and collaboration among specialists.~        -  good interobserver reliability of clinical and radiological edentulous jaw segment~          evaluation.~        -  good reliability between radiological and intraoperative investigations and~          postoperative data.~   "
76602|NCT02054663|"~     After a heart attack patients are routinely started on drugs to inhibit platelets.~     Ticagrelor is a powerful anti-platelet drug with clinical benefits. However it must be~     discontinued in some, because of increased risk of bleeding or intolerance. These patients~     need to be transitioned to another agent, such as Clopidogrel. At present, there is no~     clinical consensus on the optimal strategy for this switch. Some clinicians elect to give a~     bolus dose of clopidogrel with 600mg, while others start directly with a 75mg daily dose,~     with no evidence regarding the benefits or potential complications associated with each~     strategy. The present proposal will evaluate the pharmacodynamics of 2 strategies with~     specialized platelet function testing. We hypothesize that a bolus dose of clopidogrel~     during the switch will confer better ischemic protection without increasing bleeding risk~     for patients undergoing a switch in therapy.~   "
76603|NCT02054650|"~     The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit;~     2) the body has inherent self-regulatory mechanisms; 3) structure and function are~     interrelated; and 4) rational treatment is based on an understanding and integration of~     these concepts. Patients with type 2 diabetes mellitus often report more aches and pains~     than people without diabetes. Because osteopathic manual medicine addresses dysfunction in~     the musculoskeletal system, patients with both chronic low back pain and type 2 diabetes~     mellitus may benefit from this non-pharmacological treatment to reduce their pain, thereby~     reducing their stress and perhaps providing better clinical control for diabetes as~     demonstrated by key markers such as hemoglobin A1c and kidney function. This study is an~     extension of research completed in the OSTEOPATHIC Trial. Results of that study were~     published in the Annals of Family Medicine in March/April 2013.~   "
76666|NCT02053831|"~     In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted~     and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater~     surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.~   "
76667|NCT02053818|"~     To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics~     of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients~     undergoing coronary artery bypass with or without aortic valve replacement.~   "
76604|NCT02054637|"~     Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin~     (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction,~     abolishing almost completely bile salts output from the gallbladder. Somatostatine is also~     known to decrease acid production with significant increase of intragastric pH. In this way,~     somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder~     emptying and decreasing acid secretion.~      Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms~     and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis~     that cannot be controlled with classic therapy.~   "
76605|NCT02054624|"~     The purpose of this research study is to learn about ways to help overweight adults from~     rural areas manage their weight and increase their physical activity. An important goal of~     the study is to find out what type of follow-up program for weight management is necessary~     to help overweight and obese people keep from regaining lost weight. The study will also~     look at the ways that long-term weight-loss treatments affect blood pressure, blood fats~     (lipids), blood sugar, and physical fitness.~      You are being asked to be in this research study because increased weight and obesity are~     major health problems in the United States. You have been identified as being overweight or~     obese. People who are obese have an increased risk of developing health problems such as~     high blood pressure, diabetes, and heart disease. The rates of being overweight and obese~     are higher in rural areas of the United States than in urban and suburban areas of the~     country.~   "
76606|NCT02054611|"~     Without rigorous, high-quality training materials, the results of the LUNG-SAFE study~     examining the global incidence and outcomes of severe lung failure (acute respiratory~     distress syndrome [ARDS]) could be confused by either under-recognition of patients with, or~     misclassification of patients without, ARDS. This problem has been previously identified~     with the use of the prior ARDS definitions, particularly in patients with milder severity of~     illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only~     moderate reliability when applied by experts, although this can be improved through the use~     of training radiographs (as will be used in this educational module). The investigators~     hypothesize that the training from the educational module will allow more accurate diagnosis~     of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.~   "
76607|NCT02054598|"~     This study is a multi-site randomized, controlled trial testing the effect of a combined~     intervention that includes a colorectal cancer (CRC) screening decision aid plus patient~     navigation in a diverse, primary care patient population in clinical sites in North Carolina~     and New Mexico.~      Our primary aim is to determine the effect of the intervention on CRC screening completion~     six months after the index visit among all enrolled participants and among Latinos.~     Secondarily, we will determine how this intervention affects screening-related knowledge,~     self-efficacy, intent, and clinical communication, and examine whether these factors mediate~     the effect of the intervention on screening test completion. Lastly, we will explore whether~     insurance status, ethnicity, and patient language preference moderate the effect of the~     intervention on screening.~   "
76608|NCT02054585|"~     Dehydration and refusal to eat and drink are common complaints in the Pediatric ED~     (Emergency Department). Most of these children have had an unsuccessful trial of oral~     rehydration in their community service, therefore are treated with IV rehydration. There is~     no consensus as to which IV solution is the best one for rehydration. Children who are~     unwilling or unable to eat and drink produce Keto bodies. Theoretically, addition of glucose~     to the IV solution would prevent catabolic metabolism and reduce the keto bodies blood~     concentration which should lead to a faster objective and subjective improvement of the~     child's condition.~      The proposed study is a double blind randomized clinical trial. Children will receive either~     NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be~     known to the pharmacy only.~      Study aims:~        -  Primary aim: to compare the number of hospitalizations among dehydrated pediatric~          patients treated with either one of the IV fluids mentioned above.~        -  Secondary aim: To evaluate for the possibility of hypoglycemia secondary to~          hyperinsulinism as a response to a rapid administration of glucose.~      Study population: The study will include 700 children 6 month to 18 years of age. It will be~     conducted over 18 months in the Pediatric ED of Carmel Medical Center.~      Currently, data regarding the use of dextrose containing solutions is lacking. As~     dehydration is one of the most common medical problems encountered by the physician in the~     pediatric ED, it is of outmost importance to evaluate the optimal IV solution used in this~     setting.~   "
76609|NCT02054572|"~     This is a phase 1, open-label study to evaluate the pharmacokinetics, biotransformation, and~     excretion of [14C]AMG 416. Approximately six (6) adult male or female subjects with end~     stage renal disease requiring hemodialysis will be enrolled to receive 750 nCi of~     [14C]-labeled AMG 416 formulated in 10 mg AMG 416 administered as a single 2 mL intravenous~     dose at the end of hemodialysis.~      Subjects will spend the first approximately 12 days in confinement at the clinic (day -1~     until completion of day 11 study procedures). Blood samples, and complete collections of~     dialysate, dialysis membrane (as necessary), urine (as available), and feces will be~     analyzed for radioactivity content by accelerator mass spectrometry (AMS). Following the~     confinement period, subjects will return to the site on an outpatient basis in accordance to~     their routine dialysis sessions up to day 39. Blood and dialysate samples and dialysis~     membranes will be collected at specified times during the outpatient visit period.~   "
76610|NCT02054559|"~     To compare the efficacy and safety of chemotherapy alone and combined modality therapy in~     the treatment of localized CD20 (+) diffuse large B-cell lymphoma~   "
76611|NCT02054546|"~     The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular~     renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.~   "
76668|NCT02053805|"~     This will be a prospective diagnostic trial of screening for prostate cancer among men with~     genetic predisposition.~   "
76688|NCT02053545|"~     Although a majority of children with leukemia and most hematological malignancies (Hodgkin's~     and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of~     patients with resistant/recurrent high-risk disease are not cured with conventional~     treatment regimens. Investigators hypothesize that HSCT from a partially matched donor can~     be safe and effective for patients with very high risk hematologic malignancies when~     combined with post-transplant cyclophosphamide for prevention of graft-vs-host disease~     (GVHD).~   "
76612|NCT02054533|"~     Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the~     last ten years. Evidence now suggests that the most effective therapy early in the course of~     Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing~     medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab,~     and certolizumab. However, many CD and UC patients still ultimately require surgery despite~     the use of these medications. Side effects of the anti-TNF agents include increased risk of~     infections due to their effect on the immune system. Little is known about how use of these~     medications near the time of surgery may affect patients' risks of infection or other~     post-operative complications. The only available studies on this topic have given~     conflicting results. These studies have been limited by the fact that they have been small~     in size and retrospective. Retrospective studies primarily involve chart review as the~     method of identifying potential risk factors for infections and other complications after~     they have already occurred. This method limits both the type and quality of information/data~     that can be collected. The conflicting results have led to variance in practice patterns~     with regards to management of anti-TNF agents, the timing of surgery, and even the types of~     surgery.~      By enrolling patients at the time of their surgery, collecting extensive information may be~     possible than previously studied on potential risk factors for both infectious and~     non-infectious complications following surgery. Risk factors to be studied will include~     individual patient characteristics, disease characteristics, surgical methods, novel~     characteristics of CT scans and MRIs and extensive medication exposures. The primary~     objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk~     of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient~     history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of~     drug levels at the time of surgery has never been utilized in this way to evaluate the risk~     of anti-TNF agents in IBD. However, this has been done to assess the risk of other~     medications in different diseases.~      If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD~     patients undergoing surgery, change maybe needed in the way these medications are used~     around the time of surgery. Additionally, by collecting comprehensive information on other~     potential risk factors besides medication use patients at greatest risk for bad outcomes can~     be identified and take protective measures when possible. The aims of this study address the~     CCFA challenge to better define the risks of medical and surgical therapies to improve the~     quality of care of IBD patients undergoing surgery.~   "
76613|NCT02054520|"~     The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors~     (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in~     combination with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. We~     hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization~     or shrinkage, significant prolongation of progression-free, disease-free or overall survival~     compared to the use of immune checkpoint inhibitors alone.~   "
76614|NCT02054507|"~     The main purpose of this study is to better evaluate prematurely born children cognitive~     development at school age, with regards to birth conditions but also to social situation,~     intra family relationships, and modalities of care.~      The study will be divided into 3 parts:~        1. Children born prematurely in our level III referral Center will undergo psychometric~          evaluation at 8 to 11 years of age by routine cognitive test. The relationships between~          cognitive scores and neonatal characteristics will be determined and compared to the~          results of schoolmates born at term.~        2. The quality of parent and child relationship will be evaluated by a standardized~          questionnaire allowing the evaluation of persistent stress trauma related to premature~          birth.~        3. An anthropologic study of the utilization of care resources will also be performed~          within the follow-up network taking care of these children.~   "
76615|NCT02054494|"~     HIV-infection is associated with an increased risk for cardiovascular disease. Especially~     patients with low CD4+ counts have a higher incidence of structural heart disease.~     Myocardial T1 relaxation time, as well as T1-derived extracellular volume fraction are~     relatively new methods for non-invasive myocardial tissue characterization, including~     diffuse myocardial fibrosis.~      In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner~     (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP~     sequences, STIR imaging and LGE [Late gadolinium enhancement]. All HIV patients are treated~     in the HIV outpatient clinic of the hospital's Internal Medicine department and have an~     unremarkable history of cardiac disease. Patients are recruited from all over Germany. In~     order to obtain reference values, a subgroup of healthy, age-matched controls is included in~     this study.~      Aim of this study is to show differences in T1- and ECV-values in the investigated~     subgroups. In addition, we also want to create cut-off values for healthy and affected~     myocardium in asymptomatic HIV-infected patients. This study could show whether myocardial~     T1 mapping is a potential screening parameter for beginning heart disease as part of an~     HIV-infection, and whether an application in routine diagnostic is reasonable.~   "
76616|NCT02054481|"~     The overall purpose of this trial is to assess clinical efficacy and safety of different~     subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to~     select doses for further clinical trials.~   "
76617|NCT02054468|"~     This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required~     for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant~     rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.~   "
76618|NCT02054455|"~     The aim of the study is to evaluate the potential protective effect of Lactobacillus~     paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with~     gastro-esophageal reflux disease at long-term PPI treatment.~   "
76619|NCT02054442|"~     The investigators will perform a randomized phase II study to investigate if the addition of~     cetuximab to MTX is beneficial for the patient. Because no data on this combination are~     available the investigators will start with a phase Ib study to investigate the feasibility~     of the schedule.~   "
76620|NCT02054429|"~     The purpose of this study is to determine the safety and efficacy of lowering glucose (blood~     sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will~     determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve~     90-day functional and neurological outcomes in comparison to standard glycemic care in~     patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive~     insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8~     hours of acute ischemic stroke who have undergone endovascular therapy.~   "
76621|NCT02054416|"~     In this clinical research study the investigators will test the efficacy of an innovative,~     non-invasive methodology to reduce mortality and lower limb loss among high-risk~     medically-underserved patients with cardiovascular disease in North Philadelphia.~      Patients with cardiovascular disease and recent lower limb amputation will be treated with~     an intermittent compression device on the remaining lower limb to prevent dual amputation.~      The study hypothesis is that the study intervention will protect against further lower~     limb-loss/death and reduce cardiovascular mortality in these patients (one year effect~     against limb-loss/death).~      This study may result in better secondary prevention strategies for disadvantaged urban~     populations as well as the general population.~   "
76622|NCT02054403|"~     Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by~     means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many~     years. Patients with angle closure are particularly at risk but can be detected during an~     ophthalmological examination and sent for early preventive (laser) intervention. Current~     practice shows that patients at risk of PACG are frequently missed during routine~     examinations. Moreover, new imaging techniques like swept source optical coherence~     tomography (SS-OCT), are emerging with which the angle of the anterior chamber can be imaged~     in great detail with no burden for the patient. These techniques are already used in~     clinical practice and replace and complete part of the ophthalmic examination. However, in~     Caucasians, it is not yet known to what extent angle closure is detected in regular care and~     can be detected with this OCT device. There are few published data concerning angle closure~     and PACG in Caucasians and its characteristics.~      Objective: To quantify the presence of angle closure by gonioscopy in patients at risk of~     angle closure on SS-OCT. Secondary objectives are to quantify the presence of an increased~     intra-ocular pressure during the day or after dark provocation, to quantify morphometric~     details of the anterior chamber, structural changes, and corneal endothelial cells and to~     quantify the functional changes of the visual field.~      Study design: prospective, observational, descriptive study. Study population: Caucasian~     patients, presenting at the outpatient clinic of the University Eye Clinic Maastricht, aged~     40 to 80 years, who are diagnosed with angle closure on SS-OCT.~      Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main~     study parameter is assessment of the anterior chamber angle according to gonioscopy.~     Secondary study parameters are the presence of an increased intra-ocular pressure (IOP) (>21~     mmHg) during the day or after dark provocation (IOP rise from baseline), morphometric~     details of the anterior chamber, structural changes of the retinal nerve fiber layer, number~     of corneal endothelial cells and functional changes of the visual field Hypothesis: It is~     hypothesised that, based on its resolution and ease of use, SS-OCT is a suitable imaging~     technique to identify patients with or at risk of angle closure. It will be of value as an~     additional diagnostic instrument and may even replace gonioscopy.~   "
76623|NCT02054390|"~     Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of~     the present cohort study is to investigate whether ACEi therapy reduces the rate of~     periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention~     (PCI) among patients with metabolic syndrome.~   "
76624|NCT02054377|"~     Cystic fibrosis (CF) is a progressive disease. Symptoms include coughing, poor lung~     ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress,~     frustration, depression, irritability, worry, insomnia, behavioural issues and missed~     school/work.~      Tai chi, a Chinese form of exercise, uses slow choreographed movements, breathing exercises~     and mindfulness. Research suggests tai chi can improve physical and emotional wellbeing for~     various chronic conditions.~      This study compares methods of teaching tai chi to 70 people with CF, and evaluates the~     effect on symptoms and quality of life. Adults and children with CF will be recruited and~     randomly allocated to an intervention group or a control group. The former will receive 8~     individual face to face sessions of tai chi over a 3 month period and a video and handouts~     to aid home practice. The latter will have routine care for the first 12 weeks, followed by~     8 individual online sessions of tai chi over a 3 month period, and a video and handouts for~     home practice.~      Both groups will be encouraged to practice tai chi at home in the months following the~     taught sessions.~      Questionnaire data on how participants and their carers are coping with CF, any general~     improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will~     be collected. Data will be collected at the beginning and end of the intervention, and at 6~     and 9 months post intervention and differences between the 2 groups compared over time.~      Feedback from on line focus groups will ask about their experiences, feasibility of learning~     and practicing of tai chi, engagement with the process, perceived health impact, and~     experiences of participation.~      It is hoped that the study may show how Tai Chi can help people with CF to maintain their~     health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.~   "
76625|NCT02054364|"~     This study aims to investigate the feasibility of combining Cognitive Remediation Therapy~     (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to~     reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be~     randomly assigned to one of two groups: one group will receive FBT and CRT, and the other~     group will receive FBT and art therapy.~   "
76626|NCT02054351|"~     Advanced ovarian cancer is a high medical need indication. Cure is not available to these~     patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer~     expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane~     protein, which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody~     that binds to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill~     cancer cells by antibody-dependent cellular cytotoxicity and complement-dependent~     cytotoxicity. This trial is a first-in-human dose escalation and dose finding phase 1/2~     trial of IMAB027 in patients with recurrent advanced ovarian cancer to assess the safety and~     tolerability, the pharmacokinetics, the antitumoral activity and the immunogenicity of~     IMAB027.~   "
76627|NCT02054338|"~     The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to~     paclitaxel and gemcitabine is based on the following points: the significant antitumour~     activity of vinflunine in metastatic breast cancer (MBC) as single agent after~     anthracycline-taxane exposure and recent phase I study results of the vinflunine plus~     gemcitabine is at least additive and both drugs have a distinct mechanism of action; since~     taxanes have been approved in the adjuvant setting and are widely used in the treatment of~     early breast cancer it is worthwhile to assess new combination chemotherapy regimens as~     first line therapy for metastatic breast cancer.~   "
76628|NCT02054325|"~     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%~     hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included~     only adult women with reticular veins on the side of the thighs and mild venous~     insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.~   "
76629|NCT02054312|"~     The investigators proposed a preliminary randomized control trial of Family Based~     Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal~     Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five~     preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized~     to receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive~     nondirective psychotherapy that closely approximates treatment at usual in community mental~     health clinics. In addition to assessing the feasibility and acceptability of randomization~     and each of the treatment conditions, this project will evaluate the effects of FB-IPT and~     CCT across multiple domains, including symptomatology and psychosocial functioning.~     Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one~     week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive~     symptoms, global, social, and family functioning. Data on psychosocial risk factors~     associated with onset and recurrence of preadolescent depression will be collected prior to~     treatment and at specified intervals post-treatment in order to conduct exploratory analyses~     on correlates of positive and negative treatment outcomes for Family Based IPT. This data~     will be used to generate future hypotheses about potential mediators and moderators that~     will be incorporated into an R01 application for an efficacy study of Family Based IPT.~   "
76630|NCT02054299|"~     The purpose of this study is to determine the effect of the organic cation transporter OCT1~     polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and~     adverse effects.~   "
76631|NCT02054286|"~     The objectives of this Phase I/II trial is to evaluate the safety, tolerability and~     immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly~     active antiretroviral therapies).~      THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus):~     lentiviral vectors. They are non-replicative and not infectious. They will be injected~     intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.~      36 patients will be enrolled. Eligible patients must have an undetectable viral load and~     must be treated by HAART for more than 12 months. They will be randomly allocated to one of~     the study group and will receive the experimental drugs at one of the three doses or a~     matching placebo.~      Their anti-HIV treatment will be alleviated around each experimental drugs' administration~     to enable THV01 efficacy. HAART will be resumed one week after the second injection. 15~     weeks after resumption, HAART will be interrupted. Patients will then be monitored every 2~     weeks for CD4+ T cell counts and viral load as well as for thorough assessment of the~     elicited immune response. Stringent anti-HIV treatments resumption criteria have been~     implemented, based on the CD4+ T cell counts and the viral load.~      Statistical analysis will be performed once the last patient has reached his last visit~     (week 36 or earlier in case of early termination).~      A long-term follow-up of all enrolled patients will be performed for 5 years post-prime~     administration. This will provide additional data on the safety, on the immune response and~     the potential long-term risks/benefits associated with THV01.~   "
76632|NCT02054273|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
76633|NCT02054260|"~     The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed~     bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding~   "
76634|NCT02054247|"~     The aim of this placebo-controlled study was to evaluate the effects of pulsed and~     continuous ultrasound treatments combined with splint therapy on patients with mild and~     moderate idiopathic carpal tunnel syndrome~   "
76635|NCT02054234|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
76636|NCT02054221|"~     Compare the results of reconstruction and mitral valve replacement in the surgical treatment~     of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.~   "
76637|NCT02054208|"~     This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity~     (DLT), and exploratory efficacy of three repeated intraventricular administrations of~     NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an~     Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.~   "
76638|NCT02054195|"~     This study aimed to compare special guided training model with standard procedure on~     insertion technique for post-placental intra uterine device that provides IUD location close~     enough to fundal part of uterus to prevent expulsion~   "
76639|NCT02054182|"~     The purpose of this study is to determine whether vitamin D supplements given to children~     aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will~     improve symptoms and reduce the duration of hospitalization.~   "
76640|NCT02054169|"~     Delirium is common in older emergency department (ED) patients and often remains~     unrecognized. Existing instruments to detect delirium are often time consuming and therefore~     not feasible in the busy ED setting In this study the investigators tested the feasibility~     of the newly developed modified confusion assessment method (mCAM-ED).~   "
76641|NCT02054156|"~     The purpose of this trial is to compare the effects of treatment with tobramycin solution~     for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6~     months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a~     respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the~     study along with pulmonary function testing. Participants will receive initial treatment~     with TIS followed additional treatment with TIS if quarterly respiratory cultures are~     positive for Pa in addition to either azithromycin or placebo for 18 months.~   "
76642|NCT02054143|"~     Purpose:~        -  The purpose of this study is to examine the effect of different carbon-dioxide~          concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic~          arteries during anesthesia with sevoflurane. Sevoflurane is a widely and commonly used~          inhalational anaesthetic, that is mainly used for the maintenance of general~          anesthesia.~        -  Changes in the velocity of cerebral blood flow and arterial stiffness due to the~          different exhaled carbon-dioxide concentrations will allow us to conclude how~          sevoflurane affects these parameters during the course of the narcosis.~      Instruments:~        -  An ultrasound device called transcranial doppler (TCD) is used to measure the velocity~          of blood flow within a main artery located inside the skull.~        -  A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in~          the radial artery, from which the stiffness of the systemic vessels can be concluded.~      Measurements:~      - Examinations with the ultrasound and tonometry devices are carried out once before the~     operation, three times during the intervention, with different exhaled CO2 values and once~     after the operation is completed.~      Hypothesis:~      - Sevoflurane alters cerebral carbon-dioxide sensitivity and the stiffness of systemic~     arteries.~   "
76643|NCT02054130|"~     The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929~     (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe~     asthma.~   "
76644|NCT02054117|"~     Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other~     complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early~     phase involves the mechanical compression of brain tissue by the expanding hematoma. In a~     later phase, brain swelling develops causing further compression that may lead to brain~     herniation and death. This study investigates the neuroprotective role of haptoglobin, in~     minimizing the development of brain swelling following intracerebral hemorrhage.~   "
76645|NCT02054104|"~     Background:~      During recent years, cancer-testis (CT) antigens (CTA), particularly those encoded by genes~     on the X chromosome (CT-X genes), have emerged as attractive targets for cancer~     immunotherapy. Whereas malignancies of diverse histologies express a variety of CTAs, immune~     responses to these proteins appear uncommon in cancer patients, possibly due to low-level,~     heterogeneous antigen expression, as well as immunosuppressive regulatory T cells present~     within tumor sites and systemic circulation of these individuals. Conceivably, vaccination~     of cancer patients with tumor cells expressing high levels of CTAs in combination with~     regimens that deplete or inhibit T regulatory cells will induce broad immunity to these~     antigens. In order to examine this issue, patients with primary lung and esophageal cancers,~     pleural mesotheliomas, thoracic sarcomas, thymic neoplasms and mediastinal germ cell tumors,~     as well as sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to~     lungs, pleura or mediastinum with no evidence of disease (NED) or minimal residual disease~     (MRD) following standard multidisciplinary therapy will be vaccinated with H1299 tumor cell~     lysates with Iscomatrix adjuvant. Vaccines will be administered with or without metronomic~     oral cyclophosphamide (50 mg PO BID x 7d q 14d), and celecoxib (400 mg PO BID). Serologic~     responses to a variety of recombinant CTAs as well as immunologic responses to autologous~     tumor or epigenetically modified autologous EBVtransformed lymphocytes will be assessed~     before and after a six month vaccination period.~      Primary Objectives:~      1. To assess the frequency of immunologic responses to CTAs in patients with thoracic~     malignancies following vaccinations with H1299 cell lysate/Iscomatrix(TM) vaccines alone in~     comparison to patients with thoracic malignancies following vaccinations with H1299 cell~     lysate/Iscomatrix vaccines in combination with metronomic cyclophosphamide and celecoxib.~      Secondary Objectives:~        1. To examine if oral metronomic cyclophosphamide and celecoxib therapy diminishes the~          number and percentage of T regulatory cells and diminishes activity of these cells in~          patients with thoracic malignancies are at risk of recurrence.~        2. To examine if H1299 cell lysate/Iscomatrix(TM) vaccination enhances immunologic~          response to autologous tumor or epigenetically modified autologous EBV-transformed~          lymphocytes (B cells).~      Eligibility:~        -  Patients with histologically or cytologically proven small cell or non-small cell lung~          cancer (SCLC;NSCLC), esophageal cancer (EsC), malignant pleural mesothelioma (MPM) ,~          thymic or mediastinal germ cell tumors, thoracic sarcomas, or melanomas, sarcomas, or~          epithelial malignancies metastatic to lungs, pleura or mediastinum who have no clinical~          evidence of active disease (NED), or minimal residual disease (MRD) not readily~          accessible by non-invasive biopsy or resection/radiation following standard therapy~          completed within the past 26 weeks.~        -  Patients must be 18 years or older with an ECOG performance status of 0 2.~        -  Patients must have adequate bone marrow, kidney, liver, lung and cardiac function.~        -  Patients may not be on systemic immunosuppressive medications at time vaccinations~          commence~      Design:~        -  Following recovery from surgery, chemotherapy, or chemo/XRT, patients with NED or MRD~          will be vaccinated via IM injection with H1299 cell lysates and Iscomatrix(TM) adjuvant~          monthly for 6 months.~        -  Vaccines will be administered with or without with metronomic oral cyclophosphamide and~          celecoxib.~        -  Systemic toxicities and immunologic response to therapy will be recorded. Pre and post~          vaccination serologic and cell mediated responses to a standard panel of CT antigens as~          well as autologous tumor cells (if available) and EBV-transformed lymphocytes will be~          assessed before and after vaccination.~        -  Numbers/percentages and function of T regulatory cells in peripheral blood will be~          assessed before, during, and after vaccinations.~        -  Patients will be followed in the clinic with routine staging scans until disease~          recurrence.~        -  The trial will randomize 28 evaluable patients per arm to either receive vaccine alone~          or vaccine plus chemotherapy in order to have 80% power to determine if the frequency~          of immune responses on the combination arm exceeds that of the vaccine alone arm, if~          the expected frequencies of immune responses on the two arms were 20% and 50%, using a~          one-sided 0.10 alpha level Fisher s exact test.~        -  Approximately 60 patients will be accrued to this trial.~   "
76721|NCT02053116|"~     A Phase 2a study to evaluate the effects of an investigational compound administered at 200~     mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2~     Diabetes Mellitus (T2DM).~   "
76646|NCT02054091|"~     Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered~     as the best for the digestive system followed by donor milk. Preterm infant formula is~     related to more feeding problems and other gut complications in these babies, such as~     necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth~     factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many~     other situations to promote health. The investigators plan to give bovine colostrum to~     preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6~     weeks of gestational age, in order to promote feeding and intestinal health in these babies.~     This current study is a feasibility pilot study and the investigators hypothesized that~     supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14~     days of life in preterm infants.~   "
76647|NCT02054078|"~     Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently~     recognized as the most reliable method to control malignant pleural effusion is pleural~     fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci,~     but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such~     as chest infections, catheter migration and blockage etc. The investigators need a reliable~     methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and~     improve quality of life. The purpose of this study was to determine the efficacy and Safety~     of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions~     (MPE) in patients.~   "
76648|NCT02054065|"~     This study proposes to expand upon previous research by studying the effects of a~     urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs~     with a large, randomized controlled trial within a three-hospital academic medical center.~      Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter~     days and decrease the number of catheter associated urinary tract infections (CAUTIs), but~     will not affect the catheter re-insertion rate.~   "
76649|NCT02054052|"~     Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs~     injection is important in the treatment. Non- cytotoxic drugs include those with a~     sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain~     despite of no influence on the following chemotherapy. Tumor angiogenesis is important in~     producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness~     successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also~     effective in treating MPE.~   "
76650|NCT02054039|"~     - Postoperative pulmonary complications in patients undergoing cardiac surgery are a major~     clinical problem, presenting negative impact on morbidity, mortality , length of hospital~     stay and health care costs. Although physical therapy has been widely used as a resource to~     improve lung function in the postoperative period, the adoption of routine procedures of~     physical therapy needs be discussed.~        -  Incentive spirometers are mechanical devices used to reduce postoperative pulmonary~          complications. In general, they are activated by an inspiratory effort, visualized by~          an uplifted plate or ball in a transparent cylinder during sustained inspiration.~        -  Breath Stacking is a technique allowing the patient inhale a greater volume of air,~          kept for a longer period of time using a one-way valve, thus promoting the accumulation~          of successive inspiratory volume and preventing exhalation.~        -  The objective of the study is to evaluate the effectiveness of two different techniques~          of respiratory therapy on both reducing postoperative pulmonary complications and~          improving lung function.~        -  Type of study : randomized clinical trial~        -  Hypothesis~             1. Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath~               Stacking ( BS ) may present similar effectiveness on reducing pulmonary~               complications, improving lung function and respiratory muscle strength ( MIP and~               MEP), as well as reducing hospital stay .~             2. Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than~               Breath Stacking on reducing pulmonary complications, improving lung function and~               respiratory muscle strength, as well as reducing hospital stay.~   "
76651|NCT02054026|"~     The purpose of this study is to evaluate the effectiveness of an eight-hour version of~     Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use,~     number of sexual partners, and pregnancy.~   "
76652|NCT02054013|"~     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older~     than 60 years. The clinical picture of the disease includes lower urinary tract symptoms~     such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual~     dysfunction in some individuals. Medical therapy is usually the first-line treatment.~     However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses~     more invasive treatment options have to be taken into consideration. In cases with moderate~     to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate~     (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than~     60-80ml and the procedure is associated with a complication rate. The cumulative short-term~     morbidity rate is around 11% and the necessity for surgical revision is as high as 6%.~     Bleeding requiring transfusions and transurethral resection syndrome represent potentially~     serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been~     suggested as a minimal invasive alternative procedure, which can be performed in an~     outpatient setting with rapid recovery and low morbidity.~      The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH~     compared to conventional and established TUR-P.~   "
76653|NCT02054000|"~     The goal of this study was to evaluate the acute effect of intracoronary administration of~     tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow~     phenomenon undergoing primary percutaneous coronary intervention (PCI).~   "
76669|NCT02053792|"~     This study will examine the long-term safety and efficacy of rIX-FP for the control and~     prevention of bleeding episodes in children and adults with severe hemophilia B. The study~     will include subjects who have not previously been treated with Factor IX products, subjects~     who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major~     non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in~     study.~      A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with~     hemophilia B who are undergoing non-emergency major or minor surgery.~   "
76654|NCT02053987|"~     An Early Supported Discharge (ESD) service for stroke is an evidence based intervention that~     aims to enable a particular group of patients who have a mild to moderate stroke to be~     discharged from hospital early and receive the same intensity of rehabilitation in their~     home. Analysis of almost 1600 patients has demonstrated that ESD can reduce long term~     dependency, decrease admission to institutionalized care as well as shorten hospital stay.~     This model has also been shown to reduce death and institutionalized care at five years~     (Fjaetoft et al, 2011) and has been shown to be cost effective (Saka, 2005.) A study by~     National Heath Service (NHS) London showed that patient outcomes has not been affected by~     being treated at home and that there have not been an increase in readmissions due to the~     setting up of an ESD service.~      However, those with moderate to severe strokes are often not eligible for ESD~     rehabilitation.~      This study aims to offer twenty Camden residents an Enhanced Early Supported Discharge~     service in which stroke survivors with moderate to severe impairments are eligible.~     Participants will be recruited from the University College London Hospital (UCLH)l Hyper~     Acute Stroke Unit and acute stroke units at UCLH and the Royal Free Hospital.~      This study will compare health and economic outcomes of early Multidisciplinary stroke~     rehabilitation in the community compared to traditional inpatient and community~     Multidisciplinary rehabilitation for people with moderate to severe post stroke impairments.~      We will also collect the views of the participants and their carers regarding being treated~     at home.~      The objectives are to discover:~        1. What impact does the implementation of an Enhanced ESD service for stroke survivors~          with moderate to severe impairments have on clinical and cost outcomes compared to an~          unchanged care pathway in a neighbouring borough?~        2. What are the staff, participant and carer views and experiences of an Enhanced ESD~          service?~   "
76655|NCT02053974|"~     This study sought to investigate the whether spironolactone protects the heart against~     anthracycline-induced cardiotoxicity.~   "
76656|NCT02053961|"~     The study is a double-blind study designed to evaluate the efficacy of deep transcranial~     magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the~     treatment of patients with tinnitus~   "
76657|NCT02053948|"~     The use of temporary stomas has been demonstrated to reduce septic complications after~     colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary~     to reduce the number of complications secondary to ostomy takedowns, namely wound infection.~     The aim of this study is to compare the rates of superficial wound infection, healing time~     and patient satisfaction after pursestring closure vs gunsight skin incision and closure~     technique closure.~   "
76658|NCT02053935|"~     This is a clinical study of a drug named dopamine and how it affects our bodies ability to~     make and secrete insulin. Insulin is a hormone made in the pancreas that helps our body~     regulate sugar levels. We think that this drug decreases the amount of insulin our body~     makes and causes our sugar levels to be high. When you are critically ill there can be many~     adverse effects if you have sugar levels that are too high.~   "
76659|NCT02053922|"~     The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective~     Cesarean Section~   "
76660|NCT02053909|"~     Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude~     in the first year after bypass surgery, leading to adverse cardiovascular outcomes,~     including recurrent angina, myocardial infarction, and the need for repeat coronary~     intervention. While aspirin is the standard antiplatelet treatment after CABG surgery,~     10-20% of vein grafts continue to occlude despite contemporary secondary preventative~     therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor~     treatment leads to a more pronounced platelet inhibition, and may substantially improve~     graft patency following CABG compared to aspirin. No data has yet to be collected regarding~     the impact of ticagrelor on saphenous vein graft patency following CABG. In this context,~     the investigators seek to compare vein graft patency between patients randomized to receive~     aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the~     early postoperative period, and continuing for 2 years after CABG.~   "
76661|NCT02053896|"~     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with~     Type 1 Gaucher disease previously treated with Imiglucerase.~   "
76662|NCT02053883|"~     This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study~     designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical~     spinal cord injury. During the trial, high and low doses of Cethrin will be compared with~     placebo.~   "
76663|NCT02053870|"~     This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in~     patients with lower respiratory tract infection (LRTI).~      Patients will be recruited from a central Hospital and their demographic and anthropometric~     data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will~     be collected within 24h of the first appointment. Then, patients will be randomly allocated~     to either conventional treatment or conventional treatment plus respiratory physiotherapy.~     Conventional treatment will consist on daily medical treatment prescribed by the physician.~     Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of~     breathing retraining and chest clearance techniques, exercises for thoracic mobility,~     expansion and flexibility, cardiorespiratory exercise training and education about the~     disease.~      It is expected that ALS will be responsive to changes in patients' lung function after~     treatment. It is also expected that, by including a respiratory physiotherapy component in~     the treatment of patients with LRTI, they will express more improvements in a shorter period~     of time.~   "
76664|NCT02053857|"~     To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty~     acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as~     standard RUTF.~   "
76665|NCT02053844|"~     This project aims to assess the impact of a web-based health care cost and quality tool that~     is being implemented by a health plan for its members. The study will focus on members~     working for medium to large employers that have more than 90% of employees enrolled in~     deductible and tiered network health plans. The study will use an interrupted time series~     (ITS) design that includes random allocation of half of these employers to a study arm that~     will receive enhanced promotion of the tool and a $500 lottery incentive for its use in~     order to increase take-up. With these two study groups (a high-dose group receiving~     enhanced promotion and a lottery, and a low-dose group receiving routine promotion of the~     tool), the study will be able to evaluate whether access to a price transparency tool leads~     to reduced costs and more value-driven member behavior, and whether extra promotion~     increases take-up.~      Members in the high-dose group who use the tool will be eligible to enter a monthly lottery~     to win a $500 prize during the 12-month intervention period. In addition to the lottery,~     employers in the high-dose group will receive additional promotional strategies such as a~     mailing and messages through the plan's member web portal to promote the tool and the~     lottery, and e-mails and flyers for employers to promote the tool and lottery to employees.~      The aims of this project are to: 1) examine take-up of the tool and factors that predict~     take-up; and 2) to examine the impact of the tool on total and out-of-pocket health care~     costs and utilization~   "
76670|NCT02053779|"~     Purpose:The aim of this project is to prospectively determine whether a single dose of~     GnRH-agonist administered at the time of implantation increases or not the reproductive~     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm~     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic~     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.~      Acronyms:~      GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing~     hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic~     sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing~     GnRH-agonist OPU: ovum pick up NaCl: sodium chloride~   "
76671|NCT02053766|"~     This pilot study is a prospective, randomized clinical trial to evaluate the effect of~     anesthesia in the mitochondrial dysfunction patient.~   "
76672|NCT02053753|"~     Approximately 140 male and female healthy subjects will be randomized (1:1 ratio) to receive~     a 120 mg single dose of denosumab either as a 1.7 mL single injection of 70 mg/mL denosumab~     CP4 (Treatment A) or as a 1.7 mL single injection of 70 mg/mL denosumab CP2 (Treatment B).~     Subjects will be admitted to the research facility on day -1 and remain in the research~     facility through day 2. The subjects will return to the research facility on an outpatient~     basis. The PK, PD, and safety assessments will be conducted during the inpatient stay and at~     regular intervals during the 18-week treatment period.~   "
76673|NCT02053740|"~     Participants and study design:~      Subjects were recruited and selected for uremic patients on maintenance hemodialysis (HD)~     who informed us of their interest in the investigators study and were mentally capable to~     give an informed written consent and willing to comply with study requirements. The~     inclusion criteria were 18 years or older, with at least 3 months maintenance HD. The~     exclusion criteria were malignancy, acute infection, gastrointestinal bleeding, pregnancy,~     and inability to comply with the requirements of study.~      69 respondents were enrolled in this trial. A single-center quasi-randomized controlled~     clinical trial was designed based on the patients in the care of one attending physician.~     Eligible subjects were allocated to study and control group, and the basic characteristics~     between the experimental group and control group were matched. There was no significant~     difference regarding gender, aged, education level, comorbidities between these two groups.~     The experimental group was treated with Ren Shen Yang Rong Tang (R-S-Y-R-T) combined routine~     western medicine, and the control group was treated with WM alone. The experimental group~     had 32 respondents and the control group had 37 respondents. The duration of use of~     R-S-Y-R-T was 6 months. Finally, there were 27 patients in the experimental group and 32~     patients in the control group completed the study. Blood investigation, including~     biochemical profiles and inflammatory markers were checked at intervals 0, 2, 4 and 6 months~     form routine HD. The questionnaire, for the assessment of quality of life (QOL) was~     evaluated at interval 0, and 6 months.~   "
76674|NCT02053727|"~     The purpose of this study is to investigate whether the combination of abatacept along with~     entecavir (the study drugs) is safe and effective in treating symptoms related to rheumatoid~     arthritis (RA).~      Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form,~     is approved by the FDA for the treatment of RA. In this research, abatacept will be given by~     injection. A subcutaneous injection is an injection given under the skin.~      Entecavir, to be taken by mouth, is approved by the FDA for the treatment of hepatitis B.~      The study is divided into the following time periods:~      Screening Phase: Up to 4 weeks Randomized Double-blind Phase: 24 weeks Open-label Extension~     Phase: 24 weeksFollow-up Phase: a phone call after Week 48~      Each phase contains one or more study visits.~   "
76675|NCT02053714|"~     Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM).~     Unfortunately, persons with mental illness and T2DM are less likely to receive recommended~     diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to~     microvascular and macrovascular complications later in life. Evidence-based diabetes~     self-management education and support interventions have yet to be adapted for persons with~     mental illness and there have been no randomized controlled trials (RCTs) to examine their~     feasibility and efficacy. The purpose of this study is to assess the feasibility of~     conducting a RCT of a diabetes self-management intervention for persons with severe mental~     illness and T2DM.~   "
76676|NCT02053701|"~     Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration~     of up to 18 metabolites in the brain (neurochemical profile).~      The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7~     Tesla).~      Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal~     resolution and improved quantification precision.~      Aims~        1. To obtain improved neurochemical profiles in the brain using single voxel proton MRS~          at very high field (3 Tesla to 7 Tesla).~        2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to~          obtain metabolic maps at very high field (3 Tesla to 7 Tesla).~      Since this project is focused on technical development, only healthy volunteers will be~     recruited (no patients).~   "
76677|NCT02053688|"~     The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens,~     made of silicone commonly used in the contact lens industry, on healthy eye with or without~     astigmatism.~   "
76678|NCT02053675|"~     Vasopressin is a vasopressor used in patients with septic shock. However, its systemic~     hemodynamic effects and its microcirculation effects are not completely known and~     understood. This study aimed to evaluate the effect of exogenous vasopressin on sublingual~     microcirculation using the sidestream dark field technique and to correlate it with its~     systemic effects. To this prospective interventional study, patients with septic shock were~     included during the first 48 hours of use of catecholamine vasopressors, admitted to the~     intensive care unit of a university hospital. Vasopressin was administered at 0.04 U / min~     for one hour. Systemic hemodynamic measurements were obtained immediately before and 1 hour~     after vasopressin. In addition, images of sublingual microcirculation were collected through~     sidestream dark field technology. Further analysis with specific software was done after.~   "
76722|NCT02053103|"~     A Phase 2a study to evaluate the effects of an investigational compound administered at 200~     mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on~     metformin background therapy.~   "
76679|NCT02053662|"~     To develop a simple blood and urine test that we would perform before patients start their~     treatment to predict the risk that their bladder cancer might come back. To develop this~     test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer~     patients and follow them closely during and after treatment. This will include looking for~     changes in proteins and genes that might play a role in bladder cancer biology. The~     investigators will then compare the information obtained from the studies of blood, urine~     and cancer tissue between patients that are cured and those whose cancer comes back. The~     knowledge about these differences between patients can then potentially be used to develop a~     blood or urine test to tell us who has a high risk for having bladder cancer come back.~   "
76680|NCT02053649|"~     Perinatal depression is a common and serious mood disorder that increases morbidity and~     mortality in new mothers and results in poor infant/child outcomes. Current therapies often~     fail to produce recovery or are poorly tolerated and many pregnant women seek~     non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not~     available. Expectant and new mothers who suffer from circadian rhythm disruption are at risk~     for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant~     seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an~     outpatient psychiatry setting to improve treatment outcomes for patients with perinatal~     depression. IC is a multicomponent treatment consisting of bright light therapy, sleep phase~     advance, and sleep stabilization/restriction that targets the Research Domain Criteria~     (RDoC) constructs of circadian rhythms, sleep-wake behavior, social rhythms, and arousal. We~     will assess the feasibility, safety, and acceptability of an IC intervention for perinatal~     depressin by testing the treatment in expectant mothers diagnosed with major depressive~     disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual~     care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components~     and will be administered via an individualized case formulation approach tailored to each~     patient. After a baseline assessment, IC will be prescribed during 5 dedicated clinical~     visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will~     consist of medication administered by a perinatal psychiatrist and/or psychotherapy. UC will~     be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood~     will be measured in both groups by blinded clinician interview and patient self-report. We~     will assess the safety profile of the IC intervention with evaluation of side~     effects/adverse events. Importantly, the study will also examine the putative mechanisms by~     which IC is hypothesized to work and the dose of IC received by patients in the IC+UC~     group. All participants will wear wrist actigraphy/light monitors continuously during weeks~     28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and~     timing. Circadian phase (measured with salivary dim light melatonin onset) will be measured~     at baseline during pregnancy (~30 weeks gestation), at 36 weeks gestation, and at postpartum~     week 6. This pilot will allow us to refine the IC intervention for future integration into~     various clinical settings and establish an infrastructue for a larger (R01-scale) trial,~     including measuring acceptability of IC among UC clinicians and implementing web-based data~     collection to facilitate data sharing in the planned R01. Perinatal IC could have major~     public health impact due to the high prevalence of perinatal depression and its negative~     effects on mothers and their children. This project represents a first step toward achieving~     this goal, as it will provide the pilot data necessary to prepare for a larger scale~     intervention study focused on providing non-pharmacologic therapies and improving outcomes~     for women with perinatal depression.~   "
76681|NCT02053636|"~     The aim of the study is to evaluate the objective response rate (ORR) of single agent~     lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified~     with 11q amplification, or FGFR1-non amplified without 11q amplification.~   "
76682|NCT02053623|"~     Approximately one billion people suffer from hypertension worldwide. At least 10% of this~     population, that is, 100 million people, also suffers from associated chronic conditions~     namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF).~     Personal interaction with medical practitioners (doctors) and review of published clinical~     research confirms that current non-invasive automatic blood pressure (BP) monitors that rely~     on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak~     nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP~     estimation can lead to wrong diagnoses and hence to complications such as stokes and heart~     attacks.~      The Sponsor is developing a novel non-invasive BP monitor that is similar to existing~     automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in~     conjunction with BP pulse data to provide better and more accurate measurements in the above~     chronic conditions.~      The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP~     monitor against invasive BP measurements in a small group of patients who suffer from the~     above conditions.~   "
76683|NCT02053610|"~     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of~     (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus~     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic~     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles~     of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and~     day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or~     rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,~     or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for~     disease-progression and safety will be at least 5 years. In the US, this trial is~     sponsored/managed by Genentech.~   "
76684|NCT02053597|"~     Recently, there has been a rising trend of delaying childbearing and hence more women are~     diagnosed with breast cancer before completing their families. Given the continuous decline~     in recurrences and death secondary to breast cancer and the reassuring data on the safety of~     pregnancy following breast cancer more women are inquiring into the possibility of~     preserving fertility following chemotherapy. The challenge remains in using a regimen that~     is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate~     cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP)~     followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with~     convincing results regarding its effectiveness in the early setting, and could be~     potentially associated with less ovarian toxicity being devoid of cyclophosphamide.~   "
76685|NCT02053584|"~     The study is performed to evaluate the accuracy of blood glucose level results obtained from~     fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference~     equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the~     lay-person.~      The participants will review the Dario user manual and guide and will be requested to~     operate the Dario BGMS and perform their own glucose blood test, after which they will be~     asked to complete a questionnaire. As reference the participants will be tested by~     professional caregivers both using the Dario BGMS and by YSI 2003.~   "
76686|NCT02053571|"~     The goal of this study is to evaluate an alternate approach, which involves using a 3D~     puncture path overlay, to access the portal vein during a Transjugular Intrahepatic~     Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach~     provides these benefits: improved safety of procedure, and reduced intervention time~     (including reduction of radiation exposure), which benefits both interventional radiologist~     and the patient.~      During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the~     vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is~     inserted between the portal vein (vein that carries blood from the digestive organs into the~     liver) to a hepatic vein (vein that carries blood away from the liver back to the heart).~      In the standard approach, the interventional radiologist uses two-dimensional guidance (2D -~     having the dimensions of height and width only) to locate the path between the portal vein~     and hepatic vein. However, since these two veins do not connect, this method does not~     provide information on the three-dimensional (3D) relationship between the two veins.~      In the alternate approach, the physician will have the option of using 3D guidance to locate~     the path. An on-table limited (small field of view) CT scan, used in combination with FDA~     approved imaging software, will provide a 3D image demonstrating the relationship between~     the portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray~     images to assist in needle guidance during the TIPS procedure.~      The CT scan performed will be in place of the angiograms that are typically performed.~     However, if the portal vein is not adequately seen in the CT images, the angiograms will be~     done and there will be no overlay. The procedure will proceed using the standard approach.~   "
76687|NCT02053558|"~     It has been demonstrated that female patients have poor quality of surgical recovery~     compared to male patients. Increased sensitivity to pain and increased susceptibility to~     postoperative nausea and vomiting have been attributed as causal factors. Currently, few~     strategies have been shown to improve quality of recovery in female patients undergoing~     laparoscopic hysterectomy. A better recovery in female patients undergoing outpatient~     laparoscopy is particularly desirable since those patients do not have access to potent~     intravenous medications and nursing support after hospital discharge.~      Our group has previously demonstrated that both TAP block and systemic lidocaine improve~     quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block,~     however, requires expertise, equipment (ultrasound), and additional time to perform as~     compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine~     infusion provides non-inferior quality of recovery when compared to TAP block for outpatient~     laparoscopic gynecological surgery.~      The main objective of the current investigation is to examine the effect of TAP block on~     quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic~     lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block~     for outpatient laparoscopic gynecological surgery.~      Significance: This is the first study to compare systemic lidocaine to TAP block with regard~     to quality of recovery.~      The research question; does systemic lidocaine provide similar quality of recovery as TAP~     block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior~     quality of recovery as TAP block for outpatient laparoscopy.~      Research significance: It has been shown that females have poor surgical recovery compared~     to males; this project intends to demonstrate that systemic lidocaine provides similar~     recovery as TAP blocks but it does not require the expertise, equipment, and time needed to~     perform TAP blocks.~   "
81900|NCT01985386|"~     Slow release iron capsules containing ferrous sulfate have been designed based on the~     gastric delivery system. Iron absorption from those capsules administered with and without~     meals will be measured using stable iron isotopes.~   "
76689|NCT02053532|"~     Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of~     the amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to~     abnormalities of hippocampal volume. In this pilot study we propose to use the combined~     positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose~     (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and~     directly correlate the data with the intrinsic functional connectivity of brain circuits~     that are responsible for social, emotional and cognitive processing in both individuals with~     PTSD and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is~     validated, we will then use a more specific biomarker to better understand the neurochemical~     factors that contribute to individual differences in PTSD. Thus, the data obtained from this~     pilot study will guide our future molecular imaging studies. The link between general brain~     function, specific molecular target and the intrinsic functional connectivity of brain~     circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and~     HC will be explored.~   "
76690|NCT02053519|"~     Evidence suggests that vitamin D may be directly or indirectly a co-factor for the efficacy~     of Hepatitis C virus, (HCV), antiviral therapies. The level of vitamin D necessary for~     optimum immune function is ill defined and many of those with HCV infection in Scotland are~     below these levels. Vitamin D is a cheap and safe medication, so its addition to anti-viral~     therapy should be highly cost-effective even if only a modest increase in SVR was achieved.~     Given the Scottish HCV epidemic, the world leading government response to it and the~     nationally low vitamin D levels, Scotland is perfectly placed to answer this question.~     Therefore the investigators hypothesize that vitamin D supplementation will improve SVR and~     propose a randomised controlled trial to test this hypothesis. The anticipated end of study~     date for this study is April 2015~   "
76691|NCT02053506|"~     Physical and psychological stress on military personnel during training and operational~     missions can suppress immune function. Creating superficial skin wounds via suction blisters~     can be used to detect changes in immune function. The goals of this research are to: 1)~     identify changes in immune function (blood measures and healing time of skin wounds) in~     response to sleep restriction; and, 2) test the influence of a multi-nutrient beverage and~     healthy bacteria (i.e., probiotics) on immune function (blood measures and healing time of~     skin wounds) in response to sleep restriction.~   "
76692|NCT02053493|"~     A randomized, double-blinded, placebo-controlled crossover study to assess effect of~     isosorbide mononitrate with dose up-titration on activity tolerance as assessed by~     (hip-worn, tri-axial) accelerometry.~   "
76693|NCT02053480|"~     The purpose of this study is to describe the range and incidence of symptoms, treatments,~     and complications related to pyruvate kinase deficiency (PKD). Eligible patients are those~     of all ages with known PKD or with a hemolytic anemia and a family member with PKD. The~     study will collect retrospective medical history, routine clinical care data, and quality of~     life measures at baseline and annually for patients with PKD.~   "
76694|NCT02053467|"~     The consultation-referral process is complex, involving several steps including 1) the PCP~     recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the~     specialist, 3) referral letter and information sent to specialist, 4) appointment booked and~     communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.~      There are many factors during this process which limit the effectiveness and efficiency of~     patient care. These include inequitable access for patients and providers, long wait times~     before specialist advice received/implemented, delayed communication and mismatched consult~     expectations. These gaps result in significant breakdowns in transitions of care,~     inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all~     individuals are willing or able to travel to see specialists in a large academic medical~     centre even when recommended by the PCP.~      eConsultation has the potential for improving transitions in care through improved~     communication ensuring that patients are seen by the right specialist, when necessary, with~     the right information and in a timely manner. The goal of this project is to evaluate the~     impact of eConsultation on specialist referral rates.~   "
76695|NCT02053454|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of patisiran (ALN-TTR02) in Japanese subjects~   "
76696|NCT02053441|"~     In this study will measure differences in how muscle responds to both exercise and protein~     supplements in healthy women aged 60-69. We are studying two different protein supplements-~     a standard Whey Protein and a Leucine enriched supplement. Each patient would receive either~     one of these.~   "
76697|NCT02053428|"~     Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating~     gastroenteric access through the anterior abdominal wall for nutrition and/ or compression.~     Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop~     catheters via the push technique are both used at Interventional Radiology for PIG at our~     institution. To date, there is no guideline for PIG and no direct comparison of two PIG~     techniques. The proposed pilot study is to compare the two different types of PIG techniques~     in head and neck cancer patients who require prophylactic enteral feeding by PIG. The~     purpose of the study is to assess the feasibility of a large randomized clinical trial to~     compare these two PIG techniques.~   "
76698|NCT02053415|"~     The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change~     the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the~     total fatty acids) in the membrane in red blood cells. We investigate this at two different~     doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil~     intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid~     composition, as well as product tolerance in healthy, young individuals.~   "
76723|NCT02053090|"~     This study is an acceptability and feasibility study of two adjunctive interventions: group~     education with stretching; and group acupuncture. The study population will be women with~     primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both~     interventions will be 10 weeks in length and will be conducted at the Oregon Health &~     Science University. The primary hypothesis is that both arms will be acceptable and feasible~     in the study population.~   "
76724|NCT02053077|"~     Identification of risks of the GlucoTab system in routine use.~   "
76699|NCT02053402|"~     The aim of this randomized double-blind placebo controlled study is to assess whether~     vitamin D supplementation will improve control in South African children with persistent~     asthma at an academic hospital.~      The following hypotheses will be tested: Vitamin D significantly and directly correlates~     with poor control of persistent asthma; Daily vitamin D supplementation for six months will~     result in improved control of persistent asthma compared to a placebo.~      It is intended to enroll 100 children between the ages of 6 to 12 years with persistent~     asthma on inhaled therapy. The sample size calculations are based on the hypothesis that~     vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by~     the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings. The children~     will be randomized into one of two groups; one group will be given 1200 IU of vitamin and~     the other a placebo. The vitamin D or placebo will be given in the morning daily to each~     child for six months. The children will be assessed monthly by the study physician, to~     evaluate for signs of poor asthma control e.g. persistent cough and recurrent wheezing. The~     heights and weights and peak expiratory flow meter readings will also be obtained monthly~     for six months. Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels~     at baseline, third month and at the end of the study. All enrolled children will be required~     to produce their tablet containers for pill counting on a monthly basis to ensure adherence.~   "
76700|NCT02053389|"~     This is an educational intervention study testing the effects of decision aids in promoting~     patient participation in early stage prostate cancer treatment decision making. The purpose~     of this study is to compare patient-physician communication between patients who receive a~     DVD that models patient communication strategies vs. those who do not receive a DVD. All~     patients will also receive a written decision aid that describes treatment options for early~     stage prostate cancer. The Investigators hypothesize that the DVD will:~        -  increase patients' perceptions of the importance of their preferences to their decision~          making~        -  increase patients' perceptions of their intention to discuss their values and~          preferences with their urologists and radiation oncologists~        -  increase patients' actual engagement with their physician during the clinical encounter~        -  increase the concordance between patient decision making preferences and actual~          decision making outcomes~        -  increase long term satisfaction with decision on type of treatment selected~        -  increase patient satisfaction with their decision and the decision making process~        -  influence patient perception of his physician (e.g., trust) and of the diagnosis visit~   "
76701|NCT02053376|"~     As noted, multiple pathways, including epidermal growth factor receptor (EGFR), Ras, Raf,~     Vascular Endothelial Growth Factor Receptors (VEGFR), and platelet-derived growth factor~     (PDGFR) appear to be involved in cholangiocarcinoma tumor genesis. Overexpression of these~     proteins has been shown to be associated with tumor stage, prognosis, and response to~     therapy. However, therapies targeting a single pathway have shown no clear benefit. A number~     of Phase 2 trials have been completed, or are underway, studying agents targeted to EGFR or~     VEGF - both as monotherapy and in combination with chemotherapy. These have shown varying~     increases in response rate, but have not found marked increases in progression-free or~     overall survival. This suggests that inhibition of multiple pathways simultaneously may be~     needed. Regorafenib, is an oral multikinase inhibitor targeting multiple tumor pathways,~     which has showed effectiveness as a single agent in multiple solid tumors.~      The primary objective of this clinical trial is to evaluate the progression-free survival~     (PFS) of patients receiving regorafenib after failing first-line chemotherapy. Patients with~     advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been~     treated with and failed first-line chemotherapy will be treated with regorafenib (160 mg)~     orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.~   "
76702|NCT02053363|"~     The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an~     anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex,~     reconstructive spinal fusion surgeries.~   "
76703|NCT02053350|"~     The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the~     treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with~     standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality~     and recurrent disease.~   "
76704|NCT02053337|"~     ALLEVYN◊ Life and Mepilex™ Border are both layered foam dressings with a silicone adhesive~     wound contact layer. Both are indicated for the same uses; however ALLEVYN◊ Life has a~     number of attributes designed to meet a range of characteristics associated with principles~     of wellbeing.~      The aim for this evaluation is to assess, in a clinical setting and against a number of~     identified criteria, the performance of the ALLEVYN◊ Life dressing compared to Mepilex™~     Border in terms of characteristics of the attributes of wellbeing.~      ◊ Trademark of Smith & Nephew~      ™ All trademarks acknowledged~   "
76705|NCT02053324|"~     The purpose of the study is to assess a new treatment for patients with liver tumor~     metastases from colorectal cancer. The treatment has never been used in humans before. The~     treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.~      AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while~     [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the~     DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an~     atom which emits radiation.~      AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin~     will be injected into the arm vein.~      One specific property of AvidinOX is that it chemically links to the tumor tissues when it~     is injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound~     in tumor tissue, AvidinOX becomes an artificial receptor for intravenously injected~     [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.~      The treatment of liver metastases with local injection of AvidinOX and the following~     intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the~     current available treatments.~   "
76706|NCT02053311|"~     The main object of this multicenter, randomized, double-blind, placebo-controlled phase III~     trial is to assess impact of maintenance of orteronel on disease progression and hence on~     quality of life of patients with metastatic castration resistant prostate cancer pretreated~     with novel hormonal agents who have non-progressive disease after chemotherapy with a~     taxane.~   "
76707|NCT02053298|"~     Glaucoma is an optic neuropathy in which the main risk factor is intraocular pressure (IOP).~     The search for other variables involved in glaucoma pathogenesis and progression has~     identified both systemic and ocular signs of vascular dysfunction in glaucoma patients, such~     as migraine, peripheral vasospasm, systemic hypotension and cerebral microvascular ischemia.~     Ocular blood flow studies using Color Doppler Imaging (CDI) technology has demonstrated~     blood velocities and increased vascular resistance (RI) to exist in such patients when~     compared to healthy controls. However, a CDI examination provides far more additional~     information, such as arterial pulsatility (PI) and mean blood velocities (MFV). While these~     have been used for decades now to study cerebral arteries vasoreactivity, little is known~     about how these variables are changed in glaucoma patients. We have recently demonstrated~     that these variables can be used to identify a change in the normal vascular activity when~     there is increased resistance. In glaucoma patients, a cutpoint in RI of the retrobulbar~     arteries could be determined beyond which PI increased significantly. This sharp increase in~     the PI has been used as an indirect signal that the vessel's ability to buffer a decreased~     perfusion pressure has been surpassed. The normal response to a decreased perfusion in a~     vascular territory with autoregulation is an increase in dilation in the downstream~     microcirculation, increasing cross section area in an attempt to keep a steady MFV. As PI is~     calculated using the vessel's MFV [PI = (PSV-EDV)/MFV], it is highly sensitive to changes in~     this variable. As such, the cutpoints we have identified in glaucoma patients are therefore~     an indirect assessment of the vessel's autoregulation limit.~      While our data could provide the rational as to why these RI values are associated with~     progression, the clinical question arises as to whether these cutpoints can be modulated by~     topical glaucoma therapy. As some medications such as carbonic anhydrase inhibitors have~     been found to have a positive effect in disease progression in what appears to be a non-IOP~     related effect, we considered the hypothesis that these drugs could have a positive impact~     on the ocular's microcirculation vasoactive response, potentially enabling to keep a steady~     MFV into higher values of vascular resistance.~   "
76708|NCT02053285|"~     Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As~     tumors respond to treatment, preliminary data suggests that the blood volumes changes as~     well. Investigators are therefore using DECT to test whether it can be used on radiation~     treatment to rapidly assess response to treatment.~   "
76709|NCT02053272|"~     A study to compare the change in glycaemic control in participants with Type 2 diabetes when~     treated with GWP42004 or placebo as add-on therapy to metformin over a period of 12 weeks.~     The safety and tolerability of GWP42004 compared with placebo will also be assessed.~   "
76710|NCT02053259|"~     The purpose of this study is to develop and evaluate adaptive goal setting and feedback~     interventions (Adaptive Interventions) to promote physical activity behaviors and compare it~     to static physical activity interventions (Static Interventions) using two levels of goal~     setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures~     (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All~     four groups will receive the intervention via a semi-automated text message system developed~     by the investigators study team.~      The primary aim of this study will be to:~        1. Evaluate whether the adaptive interventions result in greater change in physical~          activity (pedometer-measured steps/day) compared to the static Intervention groups.~          HYPOTHESES: Participants in the adaptive interventions will increase their steps/day~          more than participants in the Static Intervention groups. The Adaptive Goals and~          Reinforcement Group will outperform the other 3 groups.~           The secondary aims of this study will be to:~        2. Evaluate the effectiveness of the adaptive and static goal interventions in improving~          anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES:~          Participants in the adaptive interventions will show greater improvements in fitness,~          lean and fat body mass, and serum biomarkers than participants in the Static~          Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the~          other 3 groups.~        3. to assess participants' satisfaction with the overall program.~   "
76711|NCT02053246|"~     Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of~     pulmonary hypertension (PH). Despite the severity of this disease, no established treatments~     exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart~     failure, but not used in patients with PH. Due to some additional properties it possesses,~     the investigators believe nebivolol will improve disease severity in patients with PH~     associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH~     severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.~   "
76712|NCT02053233|"~     The robot assisted therapy is one of the new developed technologies for recovery after~     stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery~     after stroke.~   "
76713|NCT02053220|"~     To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour~     tissue when administered by intra-tumoural injection or within colon, non-small cell lung,~     bladder and renal cell tumour tissues following ColoAd1 administration by intravenous~     infusion.~   "
76714|NCT02053207|"~     The purpose of this study is to evaluate the feasibility of administering a 20-day~     preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of~     cardiac surgical patients.~   "
76715|NCT02053194|"~     The objective of this trial is to test the beneficial effect of a pharmacist-initiated~     knowledge transfer intervention to both patients and prescribers on the discontinuation of~     inappropriate prescriptions, compared to usual care. The investigators hypothesize that the~     pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over~     6-months compared to usual care. The intervention consists of simultaneously educating~     consumers and providing physicians with an evidence-based pharmaceutical opinion on~     inappropriate prescriptions.~   "
76716|NCT02053181|"~     The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in~     subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the~     quantity of cadazolid absorbed into the systemic circulation.~   "
76717|NCT02053168|"~     Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring~     primary ventral and incisional hernias.~   "
76718|NCT02053155|"~     Implementation of a perioperative smoking cessation program with computer based patient~     education increases the rate of short term (1 month) and long term (6 month) reduces the~     incidence of perioperative complications in elective surgical patients.~   "
76719|NCT02053142|"~     This is a prospective study to evaluate the pharmacokinetics, clinical and virologic~     response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African~     women.~   "
76720|NCT02053129|"~     This is a pilot pulmonary TB screening program done in three antenatal care clinics in~     Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and~     to determine the sensitivity and specificity of symptom-based TB screening.~   "
76725|NCT02053064|"~     P2-SAF-301 is an open-label interventional study without administration of investigational~     product, evaluating the long-term safety and tolerability of intracerebral SAF-301~     previously administered to 4 patients with Sanfilippo type A syndrome.~      The primary objective is to collect additional safety and tolerability data on intracerebral~     SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.~      The secondary objective is to further collect data to assess the effects of SAF-301 on~     neurological and psychological status, and potential biological markers.~   "
76726|NCT02053051|"~     This study aims to assess the safety and efficacy of a novel advanced bolus calculator in~     subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin~     dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm~     that requires five subject-specific parameters as input to generate a recommended bolus~     insulin dose:~        -  current blood glucose (mmol/L)~        -  target blood glucose (mmol/L)~        -  insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)~        -  total grams of carbohydrate in meals~        -  insulin sensitivity factor (reduction in glucose per 1 unit of insulin)~      The Diabetes Technology team at Imperial College have developed a novel advanced bolus~     calculator. The complete integrated system consists of a commercially available smartphone~     that holds the novel advanced algorithm. The system requires regular updates of cases~     derived from retrospective blinded continuous glucose monitoring data and for this a~     commercially available glucose sensor will be used. Each new case includes information about~     the problem (e.g. capillary blood glucose, meal information and physical exercise), solution~     (recommended insulin dose) and outcome (blood glucose following a meal). The novel decision~     support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence~     technique that tries to solve newly encountered problems by applying the solutions learned~     from solved problems encountered in the past.~      The end-product is therefore a subject specific insulin bolus calculator that continues to~     improve with time. The project utilises commercially available glucose sensors and~     smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The~     aim of the ABC4D is to minimise high and low glucose excursions which are associated with~     the complications of diabetes including blindness, kidney failure, nerve damage and~     cardiovascular disease.~      The clinical study has been designed to incrementally assess the device's ability to manage~     meal time insulin requirements at breakfast and lunch in a controlled supervised clinical~     environment over 8 hours (phase 1), followed by its use in the home environment over a 6~     week period (phase 2) and finally over a 6 month period (phase 3).~   "
76727|NCT02053038|"~     Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But~     patients may have more than one narrowing and studies have shown that not all narrowings~     need to be treated. To identify the narrowings that need treating cardiologists sometimes~     quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of~     the pressure in the aorta to the pressure downstream of the narrowing).This technique~     requires the administration of drugs that add cost and time to the procedure and in some~     countries are simply unavailable. As a result despite the clear health and healthcare costs~     benefits of FFR its use is limited to less than 5% of procedure. We have developed a new~     technique called the instantaneous wave-free ratio (iFR) that does not require the~     administration of drugs for its accurate assessment. It has been approved for use in this~     indication. This study aims to compare clinical outcomes of patients whose treatment has~     been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to~     provide the same clinical outcomes as FFR its adoption will permit the clear benefits of~     this approach of identifying the coronary narrowings that really need treatment to be~     applicable to a much larger patient population and further improve healthcare costs.~   "
76728|NCT02053025|"~     The purpose of this study is to investigate the effect of eating various levels of~     mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in~     overweight volunteers.~   "
76729|NCT02053012|"~     The investigators feel that children who have OSA or sleep-disordered breathing may have a~     different reaction time than normal variants. Children who have OSA are known to have~     behavioral and sleep patterns that are different. It makes sense their reaction time may be~     different than normal as well. We plan to measure reaction times via a 10 minute psychomotor~     vigilance test device in children who snore who are coming in for a sleep study or for~     adenotonsillectomy.~   "
76730|NCT02052999|"~     The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of~     Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea~   "
76731|NCT02052986|"~     The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will~     correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.~   "
76732|NCT02052973|"~     This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis~     on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children~     8-10 years old, free of caries, without orthodontic appliances and without having undergone~     antibiotic therapy until three weeks before the start of the study. Saliva will be collected~     before, immediately after, 24 hours and 30 days after application of the varnish. The~     collection of biofilm will be performed before, after, 24 hours and 30 days after~     application of the varnish. Data will be collected and compared between periods.~   "
76733|NCT02052960|"~     The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients~     with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in~     combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).~   "
76734|NCT02052947|"~     One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic~     approaches in elderly is to target the main pathological process responsible for disability~     and dependency. However, a progressive cognitive impairment occurring after the age of 70 is~     often related to mixed lesions of neurodegenerative and vascular origins. Whereas young~     patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of~     AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct~     disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases~     being different to that observed in patients with AD alone. Vascular dementia (VD) and AD~     with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone.~     Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to~     their clinical, pathological heterogeneity and the multiple pathological subtypes.~      We do not know the precise role and weight of each brain lesion type in the disability~     progression in elderly. To target the actual pathological process, we need to disclose the~     functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies~     report on functional and clinical abnormalities in patients with pure pathologies. Thus,~     co-morbid processes involved in the transition from an independent functional status to~     disability in the elderly with co-lesions still remain to be elucidated. Neuropathological~     examination often performed at late stages cannot answer this question at mild or moderate~     stages.~      Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF~     biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible~     for dementia. The topography of the atrophy in MRI helps to provide information about the~     etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for~     AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with~     good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF~     biological markers has led recently to their inclusion in the research diagnosis criteria of~     AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to~     be the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in~     other neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial~     temporal atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF~     biomarkers seem to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.~      The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their~     combination, that are the most predictive of functional disability in elderly presenting~     with a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.~   "
76735|NCT02052934|"~     A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and~     immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be~     conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives~     assess the safety and tolerability of dmLT vaccine when administered in three doses~     sublingually over a range of dosages in healthy adult subjects. The secondary objectives~     assess long-term safety follow-up from immunization through Month 7 post vaccination,~     following three SL doses of dmLT vaccine over a range of dosages and comparing with three~     doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy~     adult male and female subjects, ages 18 to 45. Subject participation duration is~     approximately 8 months with study duration of approximately 1.5-2 years, including 6-7~     months of follow-up.~   "
76736|NCT02052921|"~     With the possibility of pathological complete response in surgical specimens, some authors~     have proposed non-operative management of the patient group, when re-staged after~     neoadjuvant treatment, have complete clinical response. So far, this approach remains~     discussed in the literature, and there are still many uncertainties that patients with~     clinical complete response after chemoradiotherapy in fact no detectable viable tumor and~     may be omitted of radical surgical treatment. It is a still investigational approach and~     actually gained space even for patients with very high or who refuse surgery after all~     clarifications surgical risk.~      Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and~     distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant~     chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who~     underwent surgical rectal resection.~      This will be a prospective, randomized, open label phase II of surgical resection versus~     conservative treatment (observation) in patients with mid and distal rectal cancer who~     achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.~      The main objective of this study is to assess whether conservative approach is similar to~     rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the~     rectum in patients with complete clinical response after neoadjuvant therapy combined~     chemoradiotherapy.~      Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis~     of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete~     clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical~     and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.~      Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice.~     The period for randomization of patients will be 12 weeks after the last dose of~     radiotherapy / chemotherapy, so that we can properly assess the antitumor response as~     described above. After randomization, patients in the surgical group will undergo resection~     of the rectum with complete excision of mesorectal within 2 weeks after randomization.~   "
76737|NCT02052908|"~     This randomized phase Ib trial studies the side effects and best dose of naproxen in~     preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in~     patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer~     from forming. The use of naproxen may keep cancer from forming in patients with Lynch~     syndrome.~   "
76738|NCT02052895|"~     This is an observational study to evaluate the diagnostic accuracy of presepsin levels to~     discriminate between sepsis and SIRS upon presentation with critical illness compatible with~     either sepsis or systemic inflammatory response syndrome (SIRS).~   "
76739|NCT02052882|"~     This study is to determine if using weekly romiplostim injections will improve the patient's~     platelet count more effectively than simply waiting for the platelets to improve on its own,~     and if romiplostim will also allow the patient to receive at least 2 further cycles of~     chemotherapy without thrombocytopenia.~   "
76740|NCT02052869|"~     In endotracheal intubation, it is essential that the trachea is intubated and not the~     esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the~     endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are~     available in the operating theatre are not appropriate for out-of-hospital situations~     because of several reasons. Moreover, these methods mostly take some time to provide the~     desired information and don't have optimal specificity and sensitivity. In order to allow~     fast diagnosis of this potentially fatal complication, we have developed a fully-automatic~     detection device to diagnose endotracheal tube malpositioning within 2 seconds.~      A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in~     healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).~      A new stand-alone device with integrated sensors and microprocessor was developed that gives~     immediate diagnosis, and stores data for subsequent research purpose. This device will be~     evaluated in perioperative situations to demonstrate the high sensitivity and specificity in~     patients in a clinical setting.~   "
76741|NCT02052856|"~     The purpose of this study is to evaluate the incidence and degree of bone tunnel widening~     between two groups who have undergone anterior cruciate ligament reconstructive surgery. The~     two groups have undergone different graft fixation methods: an interference screw/suspensory~     button fixation hybrid technique, and an all-inside suspensory method fixation. Tunnels are~     created at the time of surgery for graft placement and fixation, but have been known to~     enlarge post-operatively. Little has been studied on the relatively new all-inside~     technique. X-rays of the operative knee will be used to assess tunnel width. Secondary~     outcomes will include clinical evaluation and outcome scoring questionnaires~   "
76742|NCT02052843|"~     The evaluation will examine whether the Steps to Success enhanced home visits are more~     effective at delaying repeat pregnancies than are traditional Healthy Families home visits.~   "
76743|NCT02052830|"~     The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying~     sexual initiation on adolescent males in Eastern Iowa.~   "
76744|NCT02052817|"~     The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and~     has been shown to heal ulcers at a rapid rate in preliminary experience in patients with~     plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based~     on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates~     of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the~     Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates~     will be determined clinically and by blinded, computer-assisted planimetry of digital images~     over a 12 week period. The pressure on the plantar surface will be measured via a pressure~     sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on~     the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.~   "
76745|NCT02052804|"~     The objectives of this study are: 1) to design new diagnostic criteria used to accurately~     define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk~     factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular~     mechanisms involved with the development and progression of HFpEF; 4) to design and test new~     therapeutic strategies for patients with HFpEF.~   "
76746|NCT02052791|"~     This study will test the safety and tolerability of multiple doses of IONIS-SMNRx~     administered into the spinal fluid in patients with Spinal Muscular Atrophy, who previously~     participated in IONIS 396443-CS2 or IONIS 396443-CS10.~   "
76747|NCT02052778|"~     The purpose of this study is to determine the safety of TAS-120 and determine the most~     appropriate dose for the subsequent phase 2 safety and efficacy study in patients with~     advanced solid tumors and multiple myeloma with genetic abnormalities.~      The progression of cancers is caused by a complex series of multiple genetic and molecular~     events leading to changes in the patients DNA. The fibroblast growth factor/fibroblast~     growth factor receptor (FGF/FGFR) signaling pathway is important for normal organ, vascular~     and skeletal development. However, FGFR gene abnormalities have been linked to various~     cancers.~      TAS-120 is a highly potent, selective small molecule inhibitor of FGFR and is therefore is~     being studied as a therapy for cancer.~   "
76748|NCT02052765|"~     Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific~     morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in~     time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although~     it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden~     might be correlated to the ventricular fibrillation risk of these patients, but there is no~     mean to record the ECG over a long period of time.~      The objective of the study is to evaluate the correlation between ST elevation on the~     electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with~     the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients~     enrolled in the study are patients already implanted with a defibrillator for their Brugada~     syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and~     surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.~   "
76749|NCT02052752|"~     5 Day study to assess how quickly a topical acne product begins to work.~   "
76750|NCT02052739|"~     The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects~     in super-refractory status epilepticus (SRSE).~   "
76751|NCT02052726|"~     This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85~     years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses~     at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age~     groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the~     vaccine is, and also look at subjects' immune response to the vaccine.~   "
76752|NCT02052713|"~     The purpose of this study is to assess the bioequivalence of the second generation~     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently~     available commercial combination of dutasteride 0.5 milligram (mg) and tamsulosin HCL 0.4 mg~     capsule in healthy adult male subjects. Subjects in this study will receive either a single~     oral dose of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination~     capsule or a single dose of commercially available combination of dutasteride 0.5 mg and~     tamsulosin HCL 0.4 mg followed by a 28-day washout period both in fasted state. The study~     will enroll approximately 92 healthy adult male subjects in order to complete approximately~     76 evaluable subjects. The total duration of a subject's involvement in this study is~     anticipated to be approximately 12 weeks.~   "
76753|NCT02052687|"~     The purpose of this first-in human study is to demonstrate systemic and local tolerability~     and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy~     subjects.~      The current study has been designed with three distinct parts. Part 1 focuses on safety and~     tolerability of once daily application on the back, prior to moving forward and assessing~     the safety and tolerability in more sensitive treatment areas in Part 2 or twice daily~     application in Part 3.~   "
76754|NCT02052674|"~     The purpose of this study is to see if there are differences in urine drainage between two~     types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The~     difference between the two catheters is that one catheter is vented (the study catheter) and~     the other is a standard non-vented catheter. The vented catheter may drain urine better than~     a standard non-vented catheter.~      If a vented catheter drains the bladder better than a non-vented catheter it may lower the~     risk of retained urine in the bladder which could help prevent urinary tract infections.~   "
76755|NCT02052661|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in~     infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of~     a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.~   "
76756|NCT02052648|"~     In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide~     resistant) glioma patients. The overall goal of this study is to provide a foundation for~     future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation~     and temozolomide, or in combination with vaccine therapies.~   "
76757|NCT02052635|"~     The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in~     rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute~     coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with~     bivalirudin.~   "
76758|NCT02052622|"~     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of~     submental fat~   "
76759|NCT02052609|"~     This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827~     in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have~     completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or~     psoriatic erythroderma who have completed the Study 4827-004 (Study 004).~   "
76760|NCT02052596|"~     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK~     Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine~     in adults aged 50 years or older compared to administration of vaccines separately.~   "
76771|NCT02052453|"~     The purpose of this registry is to document incidence of electrical magnetic interference~     (EMI), change in programmed parameters or device related events in patients with Pacemakers~     (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring~     electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol)~     will be used.~   "
77507|NCT02042872|"~     In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on~     preservation of regional and total skeletal mass (DXA).~      Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,~     as evidenced by serial densitometry determinations (DXA).~   "
76761|NCT02052583|"~     Cardiac arrest is a major public health problem, with 700 000 cases per year , and a~     survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious~     complication with only a third of survivors . It is due to a series of phenomena involving~     microcirculation disorders . Cerebral oximetry is a new technique to evaluate the~     microcirculatory status . To this day it is used in cardiovascular surgery at risk of~     cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia~     and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the~     outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of~     action seem to change all the phenomena responsible for microcirculatory reperfusion~     disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C.~     However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.~      The hypothesis of this study is that cerebral oximetry value will be different in patients~     subjected to two different levels of therapeutic hypothermia in the aftermath of an extra-~     hospital cardiac arrest. These data allow a better understanding of the mechanisms~     underlying the benefit of this technique.~   "
76762|NCT02052570|"~     This is a qualitative study that will explore the experiences of school reentry following~     Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their~     parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study~     will involve four focus groups: children post -transplant, parents, teachers and PBMT~     providers in an effort to understand the successes and challenges of returning to school~     following HSCT.~   "
76763|NCT02052557|"~     The purpose of the study is to evaluate the effect of Exparel on pain control and patient~     outcome after colon resection. The investigators will evaluate the clinical course of the~     patients who receive exparel as compared to the patients who do not receive exparel. Exparel~     is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three~     days. A long acting local anesthetic should provide better pain control than conventional~     bupivacaine which has a 3.5 hour half-life.~   "
76764|NCT02052544|"~     To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to~     aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing~     heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k)~     submission.~   "
76765|NCT02052531|"~     The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by~     comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific~     Corporation in patients with dermal pruritus.~   "
76766|NCT02052518|"~     This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member,~     35 group organization whose goal is to improve the health of children in Hartford, CT. In a~     randomized control trial, the primary aim of this study is to test the initial efficacy of a~     program of enhanced home visitation with neighborhood and community support to change~     maternal behaviors related to infant nutrition (sweetened beverage/juice consumption,~     breastfeeding and introduction of solids), parenting skills (establishing routines around~     sleep, reading cues for hunger, satiety, television time) and family wellness (improving the~     home food environment, enhancing physical activity). The investigators hypothesize that at~     12 months of age, infants in the intervention arm will drink less sugar sweetened~     beverages/juices, will have ingested solids at an older age, will have been breastfed longer~     and more exclusively than infants in the control arm and will have less TV viewing, more~     established sleep routines and greater soothability (primary outcomes).~   "
76767|NCT02052505|"~     The purpose of this study is to investigate the effect of nurse-led medication reviews on~     the frequency, type and potential severity of PIP in psychiatric patients~   "
76768|NCT02052492|"~     Activated macrophages, present in excess during natural inflammatory responses, bear the~     potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to~     require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T~     lymphocytes. However, in various cancer patients the Gc protein is deglycosylated by serum~     α-N-acetyl galactosaminidase (Nagalase) secreted from cancer cells. This deglycosylated Gc~     protein, lacking the N-acetylgalactosamine monosaccharide, cannot be converted to its form~     of Macrophage Activating Factor, leading to immunosuppression rather than Macrophage~     activation against cancer cells.~      Efranat has developed cancer immunotherapy based on Macrophage Activating Factor produced~     from natural Gc protein extracted from FDA approved healthy human plasma.~      In this phase I study, the treatment is given as Intramuscular, once-weekly injection of~     EF-022, for two courses, while each course is comprised of 4 injections.~      The investigational treatment is expected to enhance immune response, thereby, improve~     patient's well being, quality of life and disease control.~      Primary objectives:~        1. To determine the safety and tolerability of EF-022 and to define the maximal tolerated~          dose (MTD) for potential administration.~        2. To identify the Dose Limiting Toxicity (DLT) of EF-022.~      Secondary objectives:~        1. To determine the 'Recommended Phase 2 Dose' (RP2D) based on MTD data, immunological and~          pharmacodynamics markers~        2. To explore preliminary efficacy of EF-022 in advanced solid tumors according to the~          'Response Evaluation Criteria in the modified Solid Tumors' (RECIST 1.1) and blood~          levels of tumor-related markers known to reflect tumor burden.~      Exploratory objectives:~        1. To assess levels of immune-related factors in peripheral blood (determined by FACS~          analysis), reflecting induced immunological activities, including but not limited to,~          natural killer (NK), monocytes (M1 and M2) and T cell subpopulations (effector vs~          regulatory, CD4+ and CD8+ cells), B cells (CD20), myeloid and dendritic cells etc.~        2. To assess the change in serum levels of protein biomarkers in the blood.~        3. To immunohistochemically assess and compare tumor derived tissue samples Pre and post~          treatment. To analyze the infiltration of different population of cells into the tumor~          bed.~   "
76769|NCT02052479|"~     The purpose of this research study is to see if there are differences between~     African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their~     bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is~     one of the most common endocrine disorders among females. Features can include anovulation~     (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive~     amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth~     on the face and body), and polycystic ovaries (small sac-like structures [cysts] on your~     ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their~     bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin~     resistance) resulting in an increased risk of diabetes. Diabetes is when you have high~     levels of glucose (sugar) in your blood. Many studies have looked at how bodies respond to~     glucose and have shown that compared to Caucasians, healthy African-Americans produce much~     more insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in~     childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the~     blood into the muscles for the body to use as energy. PCOS is associated with increased~     levels of insulin (hyperinsulinism) and not being able to use it as well (insulin~     resistance). So we want to see if there is a difference in insulin production (secretion)~     and insulin resistance between African-Americans and Caucasians girls with PCOS. To do this,~     we will look at blood glucose and insulin levels in response to giving glucose in~     African-American and Caucasian girls who have PCOS. The results of this study may ultimately~     help to more effectively target treatment therapy in individuals with PCOS that have~     increased insulin secretion and/or increased insulin resistance.~   "
76770|NCT02052466|"~     The hypothesis is that computer simulated bony impingement of the bone surrounding the~     spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional~     (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical~     scapular notching that develops following reverse total shoulder arthroplasty (TSA).~   "
76772|NCT02052440|"~     Adult medical/surgical inpatient hospital care is more difficult and more expensive when~     complicated by alcohol dependency (AD), especially for patients who develop alcohol~     withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol~     Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care~     for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7)~     has important clinical implications and requires pharmacological treatment. At present,~     there are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen~     is a GABA-B receptor agonist that has been used in the alleviation of spasticity in patients~     with multiple sclerosis since the 1970s. Baclofen has shown promise in the management of~     alcohol dependency in preclinical and clinical studies. We propose to examine baclofen in~     the prevention/amelioration of AWS in adult medical inpatients. The investigators~     hypothesize that Baclofen, as compared to placebo, will significantly reduce the number of~     adult inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72~     hours after enrollment. Further the investigators hypothesize that Baclofen, as compared to~     placebo, will significantly reduce the need for symptom-triggered benzodiazepine~     administration during the 72 hours of hospitalization. These hypotheses will be tested in~     adult inpatients who are determined to be at risk for alcohol withdrawal and are~     subsequently placed on the SEWS monitoring and treatment protocol. These patients will be~     randomized to baclofen 10mg three times daily vs placebo.~   "
76773|NCT02052427|"~     This is a prospective, randomized, placebo-controlled, double blind safety and efficacy~     clinical trial.~   "
76774|NCT02052414|"~     To determine Gralise in treating fibromyalgia pain:~        -  efficacy~        -  safety~   "
76775|NCT02052401|"~     The purpose of this study is to determine whether a home visit by an Occupational Therapist~     is effective in reducing the rehospitalization rates in elderly patients after hospital~     discharge.~   "
76776|NCT02052388|"~     The purpose of this study is to determine the safety and efficacy of three different dosing~     regimens of brilacidin compared to daptomycin for the treatment of serious skin infections.~     This study will aid in selecting the appropriate dose of brilacidin for later stage studies.~   "
76777|NCT02052375|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with~     Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of~     ASP2408.~   "
76778|NCT02052362|"~     A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given~     in combination with each other and Ritonavir(r).~   "
76779|NCT02052349|"~     This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333~     when delivered within different sites of the gastrointestinal tract in 12 healthy subjects.~   "
76780|NCT02052336|"~     Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420~     and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.~      Secondary Objective(s): To assess the safety of the coadministration of multiple dose of~     CJ-12420 and clarithromycin in healthy subjects~   "
76781|NCT02052323|"~     The purposes of this study is to determine parasitological clearance rates by microscopy for~     the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum~     malaria.~   "
76782|NCT02052310|"~     The purpose of this study is to determine whether FG-4592 (roxadustat) is safe and effective~     in the treatment of anemia in patients who have just begun dialysis treatment for end stage~     renal disease.~   "
76783|NCT02052297|"~     This is a methodology study to examine the quantification of GSK2634673F binding in humans,~     with the aim of characterising a robust, non-invasive method to quantify the specific~     binding signal for the alpha(V)beta6 protein in human tissues. This will be the first time~     that this micro-dose ligand is administered to humans. The study will consist of three~     parts; Part A, Part B and Part C. Healthy subjects will be recruited into Parts A and B of~     the study in order to gain experience with the GSK2634673F positron emission tomography~     (PET) ligand and to optimise the scanning procedures prior to administration to IPF patients~     in Part C.~   "
76784|NCT02052284|"~     Extremely low birth weight infants have significant water loss through their skin~     immediately after birth. This significant fluid loss is because they have large amounts of~     fluids, have immature skin and large surface area. Loss of fluids is associated with many~     complications. The investigators hypothesize that application of sterile water to the skin~     of these infants is associated with decreased fluid requirements in the first week of life ,~     improve skin integrity and decrease some complications of prematurity.~   "
76785|NCT02052271|"~     The purpose of this study is to determine whether transcranial cathodal direct current~     stimulation (tDCS) delivered over the cerebellum can improve essential tremor.~   "
76786|NCT02052258|"~     Opiate dependence is a serious problem, and oxytocin has many properties which make it~     attractive as a treatment for this type of substance dependence. This experiment will test~     the effects of oxytocin on a variety of brain-based processes in patients with opiate~     dependence. The investigators hypothesize that intranasal oxytocin in these conditions will~     enhance emotional processing and will have beneficial effects on stress responses in~     opiate-dependent patients.~   "
76787|NCT02052245|"~     This study aims for an in-depth characterization of human milk of mothers who delivered~     prematurely to decipher differences with milk of mothers who delivered at the expected term,~     with a particular focus on milk proteins~   "
76788|NCT02052232|"~     This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism~     during fasting and feeding in healthy older subjects.~   "
76789|NCT02052219|"~     The purpose of this study is to compare the effect of blisibimod plus standard of care~     versus placebo plus standard of care alone on the proportion of subjects achieving~     improvement in renal disease parameters.~   "
76790|NCT02052206|"~     The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in~     realization a computer assisted 3D planning compared to conventional 2D planning.~   "
76846|NCT02051478|"~     The purpose of this randomized clinical trial was to examine the widespread effects of~     thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain~     sensitivity and neck pain intensity in patients with chronic mechanical neck pain.~   "
76791|NCT02052193|"~     The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent~     anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation.~     Both drugs seem to be equally efficacious; however, their toxicity profile seems to differ.~     Serious phototoxicity has been observed in ~ 30% of patients treated with vemurafenib and in~     ~2 percent of patients treated with dabrafenib. These phototoxic reactions have developed in~     spite of informing the patients of this possible adverse event and instructing them to~     protect themselves. Manifestation of phototoxic reactions depends on the patient's habits of~     exposure and their efforts to protect themselves. The true frequency of photosensitivity can~     only be established by systematic photo-testing. In dermatology, standard test procedures~     with different UV-wavelengths and dosages have been established and the primary goal of this~     study will be to clarify the true rate of photosensitivity by these two BRAF-inhibitors.~     Furthermore, systematic experience will be collected how to best protect patients from~     phototoxic events. Dabrafenib and Vemurafenib are commercially available and considered~     standard of care for BRAF mutant metastatic melanoma in Germany. As the number of patients~     will not allow any conclusion with regard to efficacy or safety of vemurafenib, patients~     randomized to vemurafenib in part 2 will only remain on study until completion of~     phototesting.~   "
76792|NCT02052180|"~     The purpose of this study is to demonstrate improved pain control and outcomes in wrist~     operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use~     of the standard local anesthetic, Marcaine.~   "
76793|NCT02052167|"~     This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent~     JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the~     Methotrexate Prefilled Pen (including a label comprehension assessment and a device~     robustness evaluation).~   "
76794|NCT02052154|"~     Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in~     splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0~     followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M6. Duration~     of follow-up of 36 months.~      The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes~     common to the PCV and PPSV vaccines, selected because of their frequency in invasive~     infections in adults in France and their potentially reduced susceptibility to penicillin~     (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).~   "
76795|NCT02052141|"~     Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units~     and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent~     angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).~      Secondary Objectives - To assess the safety and tolerability, characterize the~     pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose~     levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.~   "
76796|NCT02052128|"~     This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with~     a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine~     endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet~     (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the~     immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After~     enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D.~     Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid~     adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a,~     the cohort will be further expanded by up to 19 more patients to a total of 29 patients to~     confirm the efficacy and safety profile of onapristone in this selected patient population~     (Stage 2b).~   "
76797|NCT02052115|"~     Overweight and physically inactive breast cancer survivors are at increased risk of breast~     cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight~     loss and exercise success include the long term effects such as fatigue, psychological~     distress and impaired executive (cognitive) function.~      This study will explore the variability in how breast cancer survivors respond to a~     behavioral weight loss intervention. The primary objectives include determining the degree~     to which success with a behavioral weight loss intervention in overweight breast cancer~     survivors is explained by measures of executive function as measured with task performance~     at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline~     only.Additionally, the study is designed to determine the degree to which selected measures~     of cancer-related symptoms account for variance in the success of breast cancer survivors at~     6 and 12 months following entry into a behavioral weight loss and exercise intervention.~   "
76798|NCT02052102|"~     The study hopes to determine whether patients with left-sided breast cancer are at an~     increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based~     chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique~     during radiotherapy treatments would further reduce dosimetric dose to the heart as compared~     to the conventional free breathing (FB) technique thus reducing cardiac toxicity as measured~     by cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid~     samples will also be collected to investigate specific biomarkers of breast cancer: BNP,~     PIIINP and CITP~   "
76799|NCT02052089|"~     The purpose of this study is to find the optimal treatment method for chronic lateral~     epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated~     tendon.The hypothesis is that there will be significant difference between treatment groups~     and control group (physiotherapy) and also there will be significant difference among~     treatment groups.~   "
76850|NCT02051426|"~     The efficacy of compounds having agonistic activity at the glycine site associated with the~     N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In~     contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy~     human organism are not known. The investigators studied neuropsychiatric and neurochemical~     effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects~     using a randomized, controlled crossover challenge design including a baseline assessment~     day and two treatment administration days (DSR and placebo in randomized order). Thirty-five~     subjects aged 23-29 years participated in the study and received a 2.1g orally administered~     DSR dose. The main outcome measures were the changes in scores of mood-related Visual~     Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey~     Auditory Verbal Learning Test (RAVLT).~   "
76800|NCT02052076|"~     In this study we will compare the health effect of two different meal patterns. In one~     subjects will consume food according to an 'irregular meal pattern' (3-9 meals/day) and the~     other 'regular meal pattern' (6 meals/day) for two weeks. The energy requirement of the~     subjects will be calculated to maintain body weight during the study. Participants will be~     provided with all the food to be consumed during the study. Initially, subjects will attend~     a screening visit in which they will complete questionnaires on medical health, eating~     habits and physical activity. Height, weight and waist circumference will be measured at~     this visit. Thereafter, subjects will be assigned to a 2-wk period following one of the two~     meal-patterns. There will be a 2-week period between the two interventions when subjects~     will consume their normal diet and at the end of this, participants will undertake the next~     meal pattern. During the two phases participants will be asked to wear an armband, which~     detects movement and measures heat loss, to assess their energy expenditure and a blood~     glucose monitoring device will be worn for three days. Before and after each 2-week~     intervention, subjects will come to the lab and will be given a test drink and blood samples~     will be obtained to evaluate the health effects of the meal patterns. Energy expenditure~     will be measured by indirect calorimetry. They will then be offered an ad-libitum meal and~     be asked to eat until they feel comfortably full. During each of the 2-week periods,~     participants will be asked to record their food intake and record their appetite sensations~     on specific days.~   "
76801|NCT02052063|"~     The stapled transanal rectal resection (STARR) has recently been recommended for patients~     with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall~     intussusception.~      The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for~     endorectal resection of the distal rectum.~      This technique significantly improves constipation. However, there are several reports of~     new-onset faecal incontinence after STARR and urgency has been identified as the major~     side-effect of this procedure.~      Although this technique has become an important surgical option in the treatment of~     obstructive defaecation syndrome, its impact on continence can be problematic and objective~     data about parameters that predict its result are not yet available One study evaluated the~     anal function after surgery in 30 patients. In this study, urgency or incontinence was~     complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were~     noticed in the endoanal exam performed at the follow-up.~      No significant difference was observed in anorectal manometry. Even if data are not~     statistically significant, resting and squeezing pressures are lower in those patients not~     satisfied.~      Currently, anal canal pressure measurements using ano-rectal manometry are the most common~     means of assessment of sphincter function. Some studies have been looking at the concept of~     distending sphincter regions as a better measure of its performance.~      The functional lumen imaging probe (FLIP) is a novel technique which has the ability to~     provide real-time images of the function of human gastrointestinal sphincter during~     distension. This distensibility technique provides an important new way of studying the anal~     canal and hence may have a role in testing sphincter competence in patients with disorders~     after STARR procedure.~      Twenty-eight patients will be enrolled in this study over a period of 36 months.~      Preoperative assessment will include~        -  clinical examination~        -  the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL)~          to rate anal incontinence~        -  video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal~          sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3~          months after surgery, and will include symptom evaluation (using the same standard~          questionnaires for incontinence), clinical examination and investigation using anal~          ultrasound and endoFLIP.~      If we demonstrate that this surgical technique can cause anal lesions with decreased~     sphincter competence, this may lead to a modification of the surgical technique especially~     in patients at risk of developing postoperative anal incontinence.~   "
76802|NCT02052050|"~     The purpose of this study is to determine the effects of physical training program to~     improve deep stabilizer muscle in colorectal cancer survivors~   "
76803|NCT02052037|"~     We propose a prospective, randomized, single-blind controlled crossover study to assess the~     effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric~     measures, and overall diet quality in adults with Type 2 diabetes.~   "
76804|NCT02052024|"~     The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause~     muscle atrophy in spastic patients. The primary objective is to assess whether there is~     statistically significant difference in muscle atrophy between the two groups over a one~     year period.~   "
76805|NCT02052011|"~     The purpose of this study is to determine the effectiveness of Ranolazine for the treatment~     chest pain from disease of small vessels of the heart also known as 'microvascular angina'.~   "
76806|NCT02051998|"~     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in~     industrial countries. In the late stages of the disease, neovascular changes or the~     development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by~     the development of areas of outer retinal atrophy with continuous spread over time that is~     corresponded to an visual field defect for the patient. The pathogenesis is still~     incompletely understood. Despite the break-through in the treatment of neovascular AMD by~     intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is~     yet no treatment available to slow down or halt the disease process in GA. We and others~     have demonstrated that the total GA area progression shows large differences between~     patients. Potential factors influencing differential progression have been intensely~     studied: While neither systemic nor genetic factors have been shown to influence GA~     progression, ocular characteristics such as GA baseline size or phenotypic features of~     fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for~     increased GA progression. While these previous studies have mainly focused on the~     characterization of total GA area progression, topographic directional spread has not been~     analyzed and relevant predictive markers are yet unknown. There may be large differences in~     the local GA progression. The primary objective of this study is to identify specific~     characteristics, for the local GA progression. The knowledge of such risk factors may help~     to better understand the pathogenesis of GA. The identification of predictive markers will~     allow for better prognostic assessment of the individual disease process. The DSGA study is~     the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration)~     study (NCT00393692).~   "
76807|NCT02051985|"~     The purpose of this study is to evaluate the feasibility and the short-term effects of an~     early-start aerobic exercise training program on functional capacity, symptoms and~     neurohormonal activation in chronic heart failure patients with recent acute hemodynamic~     decompensation.~   "
76808|NCT02051972|"~     The objective of the study is to confirm clinical performance and safety of the Nanostim~     leadless cardiac pacemaker system within its intended use and according to its instructions~     for use.~   "
76809|NCT02051959|"~     -  Phantom limb pain (PLP) refers to pain in a limb that has been amputated or~          deafferented. Phantom limb pain might be related to brain cortical plastic changes.~        -  The purpose of this study is to determine the efficacy of a series of transcranial~          direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation~          method, in producing long-term reduction of phantom limb pain among amputees who~          experience such pain.~      This is a Crossover sham control.~   "
76861|NCT02050321|"~     We propose to conduct a phase 2 study to assess whether the addition of acitretin to~     vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC)~     development, a known side effect of vemurafenib therapy, in patients with advanced melanoma.~     Further, we seek a preliminary assessment as to whether the addition of acitretin to~     vemurafenib enhances the clinical efficacy of this anti-melanoma agent.~   "
76862|NCT02050308|"~     The purpose of this study is to test the effectiveness of a culturally-tailored~     Internet-based program that helps American Indian (AI) tribal college students quit smoking.~   "
76810|NCT02051946|"~     The purpose of this study is to identify whether or not injection of a study drug~     (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures~     in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity~     less than 20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be~     asked to participate in the study. The first five patients will have the Retroject device~     placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be~     placed on the eye for one minute. The second group of patients (3 total) will have the~     Retroject device placed on the eye and then an injection of ethacrynic acid into the~     episcleral vein. The third group of patients (12 total) will have the Retroject device~     placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic~     acid injection or a balanced salt solution injection. All 20 patients will then return for~     intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection.~     In addition, the patients will undergo pre and post intervention corneal endothelial~     assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety~     issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or~     permanent loss of vision.~   "
76811|NCT02051933|"~     The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at~     the time of surgery for pilon fractures, will improve ankle range-of-motion and~     functionality.~   "
76812|NCT02051920|"~     Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis~     of myocardial diseases do not exist.~      We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness~     by elastography.~      This study will include 30 patients with cardiac disease whose rigidity varies with~     underlying disease.~      The purpose of this study is to evaluate the stiffness during open heart surgery.~   "
76813|NCT02051907|"~     The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in~     reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated~     by comparing symptoms assessment during and post radiotherapy: erythema, desquamation,~     edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of~     subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will~     be made between subjects' self evaluation in the treatment group versus the control group.~     Safety will be determined by the number and severity of Adverse Events Device-Related.~   "
76814|NCT02051894|"~     1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic~     encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In~     particular it can affect how their hearts pump blood around their body thus leading to a~     poor blood supply to parts of their body such as the brain. This is known as circulatory~     failure and can contribute to poor long term outcomes such as cerebral palsy. To try and~     prevent brain damage these infants are treated with total body cooling, however this~     treatment can further effect how babies pump blood around the body, but also how drugs which~     may be used by in this condition are processed.~      In order to assess and treat this condition doctors need to be able to accurately measure~     the blood supply in an infant. However there is no agreement on how best to do this. This~     makes decisions about when to treat an infant difficult. Sometimes doctors may want to use~     drugs such as dobutamine or adrenaline but these drugs are unlicensed in babies.~      This study proposes to observe the way babies circulatory problems are treated in babies~     with HIE the in the first four days of life. In addition the study will look are two new~     measurements of a babies blood supply to see if they are a better measure of when an infant~     needs treatment. This will involve an ultrasound scan of the heart and measurement of the~     baby's oxygen levels from a probe placed on their hand. The study will also look at how the~     drug dobutamine is processed by babies. This will be done from two small extra blood tests.~     The aim of the study is to help clinicians refine the identification and treatment of~     circulatory failure in babies with HIE.~   "
76815|NCT02051881|"~     Investigating which receptors are involved in nutient sensing of enteroendocrine cells and~     on nerve endings, gives further knowledge on the kind of nutrients responsible for the~     secretion of gut hormones involved in satiety signalling. So far only little is know about~     the distribution of potential nutient sensing receptors along the gastrointestinal tract.~     The investigators are interested in the intestinal parts which highly secrete CCK and GLP-1.~     By comparing these tissues, it is expected to further elucidate which receptors are~     important for satiety signalling in the intestine.~      Having this information gives rise to further reseach on how these receptors stimulate the~     secretion of gut hormones. Moreover, knowing which receptors are involved in satiety~     signalling, gives oppertunity for targeting these receptors to increase satiety and~     influencing food intake.~      The investigators aim to investigate the distribution of the above mentioned receptors, in~     the following referred to as 'nutrient sensing receptors', which have been suggested to be~     involved in satiety signalling, throughout the intestinal tract. For these receptors the~     gene expression, localisation and protein expression will be determined at different~     locations. This will be measured in intestinal mucosal biopsies of two locations in the~     duodenum, in the terminal ileum, the ascending colon, the transverse colon and the~     descending colon.~   "
76816|NCT02051868|"~     Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy~     treatment for patients with inoperable locally recurrent or metastatic disease. The aim of~     this phase II study is compare two well known and largely used chemotherapy regimens -~     Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will~     set a standard of care for this disease and provide useful information for future Phase III~     trials.~   "
76851|NCT02051413|"~     Predictive factors and biomarkers of response to antidepressants in major depressive~     disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors~     and desensitize serotonergic and dopaminergic receptors. The study hypothesis is that~     Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants~     in major depressive disorder. In a controlled prospective open naturalistic monocentric~     3-month study, 60 patients with a major depressive disorder requiring a treatment with~     venlafaxine will be included and assessed before treatment, 1 month and 3 months~     post-treatment. 20 controlled healthy subjects matched for age and gender will also be~     assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral~     Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be~     assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.~   "
76817|NCT02051855|"~     Circulatory failure can affect up to 50% of premature infants that are admitted to neonatal~     intensive care. This can be because their heart muscle is not developed enough to send blood~     to vital organs such as the brain. This can lead to severe short term problems such as~     kidney failure and contribute to poor long term development such as cerebral palsy. In~     addition babies born too early may need more time to adapt from a circulation that relies on~     the placenta in the womb to one that is self sufficient.~      Doctors need to be able to accurately measure the blood supply in an infant. However there~     is no agreement on how best to do this. This makes decisions about when to treat an infant~     difficult. Doctors may use drugs such as dopamine or dobutamine to help a babies~     circulation. However these drugs have not been tested properly in babies older than 33 weeks~     gestation.~      This study proposes to observe the way babies older than 33 weeks circulatory problems are~     treated in the first three days of life. In addition the study will look at two new~     measurements of a babies blood supply to see if they are a better measure of when an infant~     needs treatment. This will involve an ultrasound scan of the heart and measurement of the~     child's oxygen levels from a probe placed on their hand or leg. The study will also look at~     how the drug dobutamine is processed by babies. This will be done from two small extra blood~     tests. The aim of the study is to help clinicians refine the identification and treatment of~     circulatory failure in premature babies.~   "
76818|NCT02051842|"~     Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant~     systems. This state is frequently associated with chronic diseases like obesity, insulin~     resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may~     trigger the progression of fatty liver disease, from triglyceride accumulation to~     inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative~     stress, could be an important therapeutic target to lessen the severity of the disease.~     Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but~     therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic~     complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps~     that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat~     liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver~     diseases share molecular mechanisms in the generation of oxidative stress, the investigators~     propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver~     disease, prediabetic patients.~   "
76819|NCT02051829|"~     Comparison of preoperative screening score for OSA. In a preoperative population, comparison~     of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.~   "
76820|NCT02051816|"~     Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically~     ill patients. Procedural complications including failed attempts at intubation, esophageal~     intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death~     are common in this setting. While there are many important components of successful airway~     management in critical illness, the maintenance of adequate arterial hemoglobin saturation~     from procedure initiation until endotracheal tube placement is paramount as desaturation is~     the most common factor associated with peri-intubation cardiac arrest and death.~     Interventions that either shorten the duration of time required for tube placement or~     prolong the period before desaturation may be effective in improving outcome. The high rate~     of complications and the lack of existing evidence regarding the efficacy of current airway~     management techniques in shortening the time to airway establishment or prolonging the time~     to desaturation mandates further investigation. The primary hypothesis is that video~     laryngoscopy will be superior to direct laryngoscopy in successful first attempt at~     endotracheal intubation (defined by confirmed placement of an endotracheal tube in the~     trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical~     Care Medicine fellows after controlling for the operator's past number of procedures with~     the equipment used. Also, the investigators hypothesize that the provision of apneic~     oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15~     liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and~     maintained until after completion of the procedure) will result in a higher arterial oxygen~     saturation nadir (defined as lowest noninvasive oxygenation saturation value observed~     between the administration of sedation and/or neuromuscular blockade and 2 minutes after~     successfully secured airway or death) compared to no apneic oxygenation.~   "
76821|NCT02051803|"~     The long-term goal of this program of research is to develop and disseminate an efficacious~     intervention for weight concern that will significantly increase smoking cessation rates~     among women. The overall objective of this project is to develop this intervention and~     modify it based on piloting and feedback to ensure its feasibility and acceptability. These~     objectives will be accomplished by pursuing the following specific aim: 1) develop a~     group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a~     comparison health education (HE) program and pilot both treatments with three groups of 10~     (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).~   "
76822|NCT02051790|"~     This study is designed to evaluate the agreement between florbetapir F 18 scan~     interpretation in the clinic and by expert readers.~   "
76823|NCT02051777|"~     To investigate the effect of different strategies for managing malnutrition in the community~   "
76824|NCT02051764|"~     This study will evaluate the imaging characteristics of 18F-AV-1451 in subjects with a~     previous 18F-AV-1451 scan in order to assess the rate of change of tau deposition over time.~   "
76825|NCT02051751|"~     Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis~     when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety~     and tolerability of the BYL719 and paclitaxel combination~   "
76826|NCT02051738|"~     The purpose of the study is to evaluate the effect of food on the bioavailability (how much~     medication is in your blood) of mebendazole from a single 500 mg oral dose of a~     fast-disintegrating chewable tablet formulation of mebendazole in healthy adult~     participants.~   "
76847|NCT02051465|"~     Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in~     2010 and worldwide has become the third most common cancer and second leading cause of~     cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer~     and endoscopic removal of the polyps prevents development of colon cancer.~      Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal~     resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically~     difficult to perform, labor intensive, time consuming and carries higher risks of~     complications (bleeding, perforations, etc.). The purpose of this study is to determine the~     effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is~     hypothesized that the use of this modified colonic overtube will simplify colonoscopic~     removal of difficult polyps, decrease the time needed to complete the procedure and decrease~     the rate of complications post endoscopic removal of large and flat colonic.~   "
77508|NCT02042859|"~     The purpose of this study is to determine whether the use of an FDA approved endoscopic~     bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic~     ducts.~   "
76827|NCT02051725|"~     -  Aging is associated with a progressive and generalized deterioration of physiologic~          systems and greater incidence of chronic conditions, which ultimately translates into~          functional impairment, disability and dependency.~        -  Physical activity and exercise have been recognized as key pillars for the management~          of chronic diseases in support of medical treatment, and essential to increase~          physiologic function, but there is only limited evidence indicating increased physical~          function, following exercise interventions. One of the greatest challenges in the~          science of aging and exercise is to understand whether and to which extent exercise and~          active life-style may postpone the onset of disability and/or reverse physical~          impairments.~        -  Maintenance/improvements of physical function and mobility should be considered as~          primary targets for independent living, active engagement in societal challenges, and,~          more in general, when promoting active ageing.~        -  The aim of this study is to collect preliminary data to identify the feasibility and~          sustainability of an active life-style intervention in older adults with reduced~          mobility receiving a preventive home visit from the public health care authority.~        -  This study will represent the base for a larger phase III parallel group study~          implemented in the public health care setting, with the specific aim of improving~          physical function and delay the onset of functional impairment in older adults.~   "
76828|NCT02051712|"~     The aim of the study is I. To assess whether an individualized exercise training program is~     superior as compared to usual care with respect to exercise tolerance, II. to assess whether~     intervention tools that aim to increase exercise adherence are superior to an individualized~     exercise training alone with respect to exercise tolerance and long-term effects, and III.~     to identify biomarkers that that may be implemented into novel intervention tools aiming to~     increase exercise adherence in patients with chronic heart failure.~   "
76829|NCT02051699|"~     The purpose of this study is assess the severity of osteoarthritic knee between one-leg and~     both-leg standing radiograph in primary OA knee~   "
76830|NCT02051686|"~     This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or~     hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia~     for short-term use to reduce hemorrhage and the need for replacement blood during tooth~     extraction. However, it has also been used extensively in severely injured patients after~     major trauma and during elective hip and knee replacements. Previous studies indicate TXA~     may reduce blood loss and the need for blood transfusions while being safe for use in most~     patients. TXA is fairly inexpensive and easy to obtain.~      The purpose of this study is to determine if TXA will make surgery in patients with pelvis~     and/or hip socket fractures safer and more cost efficient.~   "
76831|NCT02051673|"~     Four subjects were treated under compassionate use provisions under this study with~     facilitating cell therapy (FCRx) product manufactured using the CliniMACS (Miltenyi Biotec)~     device, rather than the Max Sep (Baxter) device.~   "
76832|NCT02051660|"~     Purpose of this randomized controlled trial is to test the efficacy of the individual~     psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German~     sample of patients with advanced cancer. The interventions aim is to reduce depression and~     distress and support psychological well-being.~   "
76833|NCT02051647|"~     To investigate whether copeptin levels increase upon a psychological stress (i.e. written~     examination) and whether copeptin levels measured immediately before the written examination~     predict success of the examination.~   "
76834|NCT02051634|"~     The purpose of this research study is to explore the effects of fermented papaya preparation~     (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of~     life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot~     study on FPP in older adults. If FPP is found to have a beneficial impact on systematic~     inflammation in this study population (adults aged 70-100 years old), then this supplement~     may be a potential treatment option to combat aging.~   "
76835|NCT02051621|"~     Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of~     choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has~     a high success rate (5). It has been recognized that patients with typical atrial flutter~     often complain of atrial fibrillation (1,2). Current clinical and experimental studies~     confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and~     raise a question, if both arrhythmias are different forms of a common electrical phenomenon~     with atrial fibrillation being the underlying clinical problem (6).~   "
76836|NCT02051608|"~     Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study~     will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer~     disease. Participants will be randomized to receive either gantenerumab subcutaneously every~     4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if~     on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).~      A positron emission tomography (PET) imaging substudy will be conducted within the main~     study. Eligible participants who provide separate informed consent will undergo PET imaging~     scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain~     amyloid load over time. The substudy's target sample size is 100 participants in each arm of~     the main study.~   "
76837|NCT02051595|"~     Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely~     used antibiotic for surgery in patients with an allergy to penicillin. During cardiac~     surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used~     and can lower the level of the antibiotic. The purpose of this study is to quantify the~     change in plasma vancomycin concentration associated with cardiopulmonary bypass and~     modified ultrafiltration.~   "
76838|NCT02051582|"~     Thirty (30) orthopaedic surgeons from the University of Florida Department of Orthopaedics~     and Rehabilitation will be recruited and enrolled in the study to determine whether having a~     laser pointed on a fluoroscopy machine can significantly decrease the amount of radiation~     exposure as measured while obtaining multiple views during surgery as well as decrease~     radiation exposure and time to accomplish the goals of surgery.~   "
76848|NCT02051452|"~     The aim of this study is to investigate whether methylphenidate (Ritalin) can actively~     induce emergence from general anesthesia in patients having a pancreaticoduodenectomy~     (Whipple procedure), a pancreatectomy, or a prostatectomy.~   "
76839|NCT02051569|"~     Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor~     serotonin function may also contribute to MDD. Recent research suggests that serotonin plays~     a role in regulating human social behaviour. Therefore it would be intriguing to investigate~     the role of serotonin in regulating the quality of everyday social interactions in a~     population at risk for MDD. Human social behaviour can be reliably assessed in everyday life~     using Ecological Momentary Assessment (EMA).~      Objective: This study aims to investigate how an experimental increase in serotonin~     influences social functioning in healthy adults with a first-degree family member diagnosed~     with MDD. The primary goal is to investigate the role of serotonin in regulating everyday~     social behaviour, measured using EMA. This will be done using oral supplementation with~     tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this~     experimental manipulation influences people's feelings as well as their perceptions of~     other's social behaviour following interpersonal events, and social cognitions at the end of~     the day. An exploratory goal is to investigate if these effects are moderated by genes~     thought to be involved in MDD.~      The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.~   "
76840|NCT02051556|"~     Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among~     patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric~     onset and progression.~      In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been~     reported to be associated with FOG episodes. As the maintenance of gait depends on the~     precise alternating movements of both legs, irregularities in rhythm, symmetry, and~     bilateral coordination may impair gait sequence, potentially causing freezing.~      Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait~     asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may~     lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is~     triggered by a breakdown in the bilateral co-ordination underlying the normal timing of~     gait. Aim of the study was to evaluate how the modulation of asymmetry through physical~     therapy might improve gait and FOG.~   "
76841|NCT02051543|"~     Insomnia is a highly prevalent condition and costly national public health problem and a~     transdiagnostic risk factor for the development of a number of internalizing/emotional~     disorders, as well as associated functional impairment. Interestingly, sleep treatments~     appear to reduce anxiety and depression in addition to improving sleep. Given the~     substantial individual and societal costs of insomnia and associated mental illness, there~     is an urgent need to better understand the mechanism through which sleep treatments improve~     daytime symptoms of depression and anxiety in order to enhance the efficacy of sleep~     treatments and ultimately prevent the development of depression and anxiety disorders~     following the onset of insomnia. Research suggests that sleep disruptions lead to emotional~     dysregulation, including increased negative affectivity and decreased positive affectivity.~     This affective reactivity may ultimately be related to the development of depression and~     anxiety. Despite the apparent link between sleep and emotion regulation, studies have not~     investigated the influence of sleep treatment on these affective dimensions. The~     investigators long term goal is to increase understanding of the mechanism of action in~     sleep treatments in relation to changes in positive and negative valence systems. The~     investigators immediate objective is to conduct a pilot study investigating changes in mean~     levels and day-to-day instability of affective dimensions following a brief behavioral~     intervention for insomnia tailored for veterans (Brief Behavioral Treatment for~     Insomnia-Military Version. The specific aims include developing a deeper understanding of~     the effects of behavioral sleep treatment on positive and negative valence systems and~     testing a model in which affective reactivity modulates the relation between sleep and~     internalizing symptoms. Both objective and subjective sleep data, as well as measures of~     affective states and depression/anxiety symptoms, will be collected pre and post-treatment~     in order to examine changes in sleep, affect and daytime symptoms over the course of~     treatment and to test a model in which affective changes mediate the relation between~     improvements in sleep and improvements in depression and anxiety. The investigators~     hypothesize that sleep treatment will improve sleep, daytime symptoms and affective~     reactivity and that changes in affect will mediate the relation between sleep and~     internalizing symptoms.~   "
76842|NCT02051530|"~     Rationale: Major depressive disorder (MDD) is a psychiatric disorder whose onset, severity,~     and duration are influenced by interpersonal factors. The serotonin system is known to~     influence MDD risk. Recent research has suggested that serotonin may also play a role in~     regulating social behaviour. Therefore, it would be interesting to study the role of~     serotonin in responses to social stimuli in individuals at risk for MDD.~      Objective: This project aims to study how changes in serotonin alter interpersonal~     functioning in adults with or without a first degree family member diagnosed with MDD. The~     primary goal is to investigate the effect of experimentally lowered brain serotonin levels~     on empathic accuracy. Secondary goals are to determine how this manipulation influences~     verbal and non-verbal communication, cardiovascular function in a social context, and mood.~     An exploratory goal is to investigate how these outcomes are related to genes thought to be~     involved in MDD.~   "
76843|NCT02051517|"~     The aim of this study is to expand the understanding of the vitreous, its solute chemistry,~     and the normal relationship of that chemistry to the chemistry of the systemic circulation~     in humans.~      Sample human vitreous from patients undergoing vitrectomy surgery and compare to results of~     metabolic chemistry panel from subject.~      Allow the research team to extract .2ml sample of the .5ml - 1.0ml vitreous that is normally~     extracted during a routine undiluted vitreous biopsy, a standard procedure performed for~     various indications. Blood draw for metabolic chemistry panel (1-2 ml).~   "
76844|NCT02051504|"~     Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a~     relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels,~     reflecting poor long term glycaemic control. To explain this relationship, the indirect~     effect of chronically high blood glucose levels on cardiovascular complications - and hence~     on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if~     HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes.~     Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the~     muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might~     have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is~     to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and~     use and hence on aerobic fitness.~   "
76845|NCT02051491|"~     In preterm infants, endotracheal mechanical ventilation is well known to cause various forms~     of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as~     ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive~     ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and~     require intubation. A relatively recent mode of NIV is non-invasive high frequency~     ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can~     be ventilated effectively. However, its efficacy in comparison with other existing modes of~     NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that~     NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure~     (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.~   "
76853|NCT02051387|"~     Despite recent advances in the understanding and treatment of schizophrenia, this~     devastating disease still affects one percent of world's population. Existing antipsychotics~     reduce psychotic symptoms but are generally not very effective in treating so called~     negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due~     to the disease. Furthermore, a significant portion of patients is refractory to all current~     treatments. Therefore new treatment strategies are needed.~      Several studies suggest a strong association between schizophrenia and the endocannabinoid~     system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of~     the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is~     known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient -~     cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one~     of the most effective modern antipsychotics, amisulpride, but it induced significantly less~     side effects.~      In this phase I safety study, the investigators will evaluate the pharmacokinetics,~     pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new~     tablet pharmaceutical preparation of cannabidiol in healthy volunteers.~   "
76854|NCT02051374|"~     Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another~     caused by degeneration of facet joints, ligaments and intervertebral discs. Most patients~     suffer from symptoms related to spinal stenosis, such as radiating pain to the lower~     extremities, and typically increased pain in the lower limbs when walking upright and~     decreased when bending forward.~      There is a moderate grade of evidence for whether patients will achieve better outcome after~     surgery when decompression is followed by fusion. In theory, fusion following decompression~     should give more stability to the operated level, thus less pain and less progression of the~     olisthesis. On the other hand, fusion procedures, in general, are associated with more~     severe complications and postoperative mortality than decompression alone.~      In summary, there is still insufficient evidence for performing fusion in addition to~     decompression for patients with LDS. The investigators are planning a trial where the main~     aim is to detect whether the intervention-related difference in outcome between~     decompression alone (DA) and decompression followed by fusion with instrumentation (DF) is~     large enough to justify the use of the fusion procedure. The proposed trial is a randomized,~     controlled, multicentre, non- inferiority trial with two parallel groups, with 15~     participating Norwegian hospitals. The main analysis will be performed 2 years after surgery~     with long-term follow-up planned at 5 and 10 years postoperatively.~   "
76855|NCT02051361|"~     Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of~     patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in~     patients with obstructive coronary artery disease. They function both to prevent abrupt~     closure of the stented artery soon after the procedure as well as to lower the need for~     repeat revascularization compared to balloon angioplasty alone . Stent restenosis and stent~     thrombosis are potential complications of coronary artery stenting; their incidence is~     highest in the first year after PCI. Stent restenosis, which occurs more frequently with~     bare metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction~     (MI). Stent thrombosis is an uncommon but serious complication that often presents as death~     and is almost always accompanied by MI, usually with ST-segment elevation. Patients are~     commonly treated with dual antiplatelet therapy (DAPT) for the recommended duration for the~     particular stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly~     lowers the risk of stent thrombosis.~   "
76856|NCT02051348|"~     Helicobator pylori (H. pylori) is a bacteria which survives in the lining of the stomach. An~     estimated 50% of the world's population is infected with H. pylori. Developing economies,~     such as in Southeast Asia, the Indian subcontinent and Latin America, have prevalence rates~     of as high as 90%.~      H. pylori infection often goes undiagnosed, as many sufferers do not experience any adverse~     symptoms. Infection with H. pylori is described as not a disease in itself but a condition~     that affects the relative risk of developing various clinical disorders of the upper~     gastrointestinal tract.' Clinically relevant symptoms could include peptic ulcer, melena or~     secondary conditions such as iron deficiency anemia or vitamin B12 deficiency.~      There is evidence that probiotics can be beneficial for those with gastrointestinal~     diseases. Pylopass contains the probiotic strain Lactobacillus reuteri, which was selected~     for its anti-H. pylori characteristics and in clinical trials has shown to result in a~     reduction in urease breath test values in subjects with H. pylori.~      The objective of this study is to evaluate the ability of Pylopass to reduce H. pylori load~     in subjects who are H. pylori positive.~   "
76857|NCT02051335|"~     The purpose of this study is to determine whether scopolamine-induced cognitive impairment~     is attenuated by the administration of roflumilast in combination with donepezil.~   "
76858|NCT02050360|"~     The purpose of this study is to determine whether on-demand sildenafil is effective in the~     treatment of Raynaud's phenomenon.~   "
76859|NCT02050347|"~     Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute~     lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be~     referred to as lymphoma or leukemia). The lymphoma or leukemia has come back or has not~     gone away after treatment (including the best treatment known for these cancers). Because~     there is no standard treatment for this cancer at this time, subjects are asked to volunteer~     to be in a gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Both antibodies and T cells~     have been used to treat patients with cancers; they have shown promise, but have not been~     strong enough to cure most patients.~      T cells can kill tumor cells but there normally are not enough of them to kill all the tumor~     cells. Some researchers have taken T cells from a person's blood, grown more of them in the~     laboratory and then given them back to the person.~      The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells~     because of a substance on the outside of these cells called CD19. CD19 antibodies have been~     used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been~     changed so that instead of floating free in the blood it is now joined to the T cells. When~     an antibody is joined to a T cell in this way it is called a chimeric receptor. The T~     lymphocytes will also contain CD28, which stimulates T cells and makes them last longer.~      Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and~     leukemia when the cells are made from the patients affected by these diseases. In this~     study, investigators are going to see if this treatment works even better when they make~     these cells from a healthy stem cell donor. If investigators are not able to collect blood~     from the stem cell donor, they will collect blood from the subject to make the CD19/CD28~     chimeric receptor-T cells.~      These CD19/CD28 chimeric receptor T cells are investigational products not approved by the~     FDA.~      The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to~     see how long T cells with this chimeric receptor last, to learn what the side effects are,~     and to see whether this therapy might help people with lymphoma or leukemia after a stem~     cell transplantation from a donor.~   "
76860|NCT02050334|"~     The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in~     increasing doses. How long the drug remains in the body will also be calculated.~   "
76863|NCT02050295|"~     Injecting local anesthetic to anesthetize a nerve or group of nerves (a 'nerve block') is an~     effective way to eliminate pain during and after surgery. There are instances when it would~     be beneficial to the patient for the nerve block to be resolved quickly rather than waiting~     for it to naturally wear off. For example, a sciatic nerve block that freezes the lower leg~     and foot typically takes over 18 hours to resolve on its own, and both the surgeon and~     patient prefer to have motor function before discharge. The investigators wish to perform a~     randomized, controlled trial to determine if infusion of a solution such as saline to 'wash~     out' the nerve block after surgery can allow the patient to be pain-free while still being~     able to move their leg and foot.~   "
76864|NCT02050282|"~     Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish~     databases show, that patients with shortness of breath in the ambulance have a very high~     mortality. Breathlessness can be caused by many different conditions - but heart diseases~     and lung diseases are dominant. The mortality is especially high in patients with~     breathlessness caused by heart disease.~      Distinguishing these different causes of breathlessness is a classical, often difficult,~     discipline in medicine. Visitation and guidance of treatment in patients with breathlessness~     in the prehospital setting relies on medical history and physical examination and as a~     consequence prehospital treatment for breathlessness is often non-specific. The use of~     heart-failure specific biomarkers may improve prehospital visitation and treatment of~     patients with breathlessness.~      We hypothesize, that~        1. Supplementing the routine examination by prehospital anesthesiologist with measurement~          of a biomarker for heart failure increases the proportion of patients with severe~          shortness of breath caused by heart disease triaged directly to department of~          cardiology~        2. This strategy does not increase the proportion of patients with severe shortness of~          breath caused by non-heart disease triaged directly to department of cardiology~   "
76865|NCT02050269|"~     The objective of this study is to assess the feasibility of estimating the clearance of~     iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal~     function in the intensive care unit through analysis of rich iohexol plasma kinetics.~   "
76866|NCT02051322|"~     Comparison between three modalities of nebulization.~   "
76867|NCT02051309|"~     Adult daily smokers motivated to quit smoking will be randomized to extended-release~     guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining~     medication with brief behavioral support. The investigators hypothesize that the active dose~     of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the~     end of the 8-week treatment phase.~   "
76868|NCT02051296|"~     The investigators are looking at whether peri-operative minocycline will reduce the duration~     of pain after minor hand surgery: carpal tunnel release and trigger finger release.~      The investigators' hypothesis is that minocycline will reduce post-operative pain.~   "
76869|NCT02051283|"~     HCC is classified as keratin (K) 19 positive or K19 negative. K19 is a biliary/hepatic~     progenitor cell (HPC) marker only expressed in a subset of HCC with poor prognosis and high~     risk of early recurrence after treatment; particularly in radio-frequency ablation (RFA).~     These patients consequently show worse survival compared to patients with K19 negative HCC.~      A recent publication has shown the value of pretreatment biopsy with K19 staining and~     suggests that the role of routine biopsies in potentially curable HCC should be~     reconsidered.~      However, currently, pretreatment biopsies are rarely performed in the diagnosis of HCC due~     to the excellent performance of magnetic resonance imaging (MRI) in detection, diagnosis and~     staging of cirrhotic livers.~      Previous publications have indicated imaging patterns that may be associated with worse~     prognostic tumoral parameters.~      If MRI determined imaging parameters could indeed provide a surrogate marker for presence of~     K19 and/or microvascular invasion as potential important prognostic factors in RFA of HCC,~     these imaging parameters may thus hold prognostic information towards RFA treatment and~     possibly predict treatment outcome. .~      The purpose of the retrospective study is thus to evaluate MRI determined imaging parameters~     at pretreatment MRI for their predictive value towards outcome (disease free survival) of~     radio-frequency ablation for hepatocellular carcinoma.~      If successful, pretreatment MRI parameters may be used for selecting patient with high risk~     of unfavorable outcome after RFA and select the patients for more aggressive treatment such~     as surgical resection or upfront transplantation.~   "
76870|NCT02051270|"~     One important issue in older adults with cognitive problems is the higher risk of fall due~     to decreased motor function and balance. The objective of this study is to evaluate the~     repercussions of mild cognitive impairment in balance in elderly.~   "
76871|NCT02051257|"~     This phase I trial studies the highest possible dose of memory enriched T cells that can be~     given following standard stem cell transplant before unmanageable side effects are seen in~     patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T~     cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory~     enriched T cells will be made from a patient's own T cells that are genetically modified in~     a laboratory. This means that the T cells are changed by inserting additional pieces of~     deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill~     lymphoma cells. Memory enriched T cells may kill the cells that are not killed by stem cell~     transplant and may lower the chances of the cancer recurring.~   "
76872|NCT02051244|"~     The purpose of this study is to determine whether by measuring changes in the thickness of~     the retinal nerve fibre layer (the photosensitive layer at the back of the eye) you could~     predict if someone would develop Alzheimer's disease in the future. The measurement is made~     by OCT (ocular coherence tomography), a noninvasive and relatively inexpensive test that~     uses light waves to scan the back of the eye.~   "
76906|NCT02050802|"~     The study is intended to demonstrate that macitentan does not have an effect on cardiac~     repolarization exceeding the threshold of regulatory concern after repeated administration~     of daily oral doses of 10 and 30 mg to healthy male and female subjects.~   "
76920|NCT02050620|"~     Using an observational prospective design, potential subjects will be identified and~     screened for eligibility via medical record review of breast cancer patients scheduled for~     radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will~     be asked to complete study questionaires prior to the start of radiation therapy and again~     during the last week of therapy.~   "
76873|NCT02051231|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent~     used in the prevention and treatment of PPH is oxytocin, which acts by binding with oxytocin~     receptors (OTR) found on myometrial cells to cause uterine contraction.~      Women who require augmentation of labour with oxytocin because of inadequate labour~     progression are at increased risk of PPH because they have received intravenous oxytocin~     which exposes the uterus (and OTR) to doses greater than would normally be found without~     medical intervention. This exposure results in OTR desensitization and decreased uterine~     sensitivity to oxytocin which may lead to the use of much higher doses of oxytocin (up to~     9x) or other agents for preventing and treating PPH with the potential for causing serious~     drug-related morbidity or fatality to the mother.~      Currently, in women who have failed labour augmentation and need to have a Cesarean~     delivery, it is not known if it would be beneficial to wait a certain period of time after~     discontinuing intravenous oxytocin before proceeding with the operation. The goal of the~     waiting time would be to allow the OTRs to recover and resensitize the uterus to the effects~     of oxytocin to avoid the need for high doses or additional uterus-contracting agents.~      Our hypothesis is that there will be a positive correlation between the magnitude of~     recovery of the myometrium's response to oxytocin and the time elapsed from the~     desensitizing oxytocin pretreatment (simulated labour augmentation).~   "
76874|NCT02051218|"~     The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained~     if administered only every 12 weeks as compared to every 4 weeks.~   "
76875|NCT02051205|"~     The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database~     of persons with Parkinson's disease (PD) in Taiwan.~   "
76876|NCT02051192|"~     Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that~     incorporate exposure therapy useful for treatment of anxiety disorders among typically~     developing children. Although a large amount of data demonstrate the effectiveness of of BT~     and CBT approaches for treating anxious youth, there is a gap in the literature for the~     effectiveness of these approaches for children under the age of seven. Evidence increasingly~     suggests that family factors such as accommodation and parenting style contribute~     significantly to the presence of anxiety symptoms as well as treatment outcomes,~     particularly in young children. These findings stress the importance of using a treatment~     approach in which parents are directly involved in education, parent training, and~     generalization of treatment effects. Therefore, this study aims to evaluate a new treatment~     program, parent-led behavioral treatment, for children ages 3 to 7 years of age who have a~     principal anxiety disorder diagnosis.~   "
76877|NCT02051179|"~     The aim of this prospective, randomized clinical trial was to assess the effectiveness of~     repair of localized clinical defects of amalgam restorations that were initially scheduled~     for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II)~     amalgam restorations, that presented one or more clinical features that deviated from the~     ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the~     repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had~     calibration exercised evaluated the restorations at baseline and ten years after according~     to seven parameters: marginal occlusal adaptation, anatomic form, surface roughness,~     marginal staining, contact, secondary caries, and luster~   "
76878|NCT02051166|"~     The purpose of this study is observe clinical practice including glucocorticoids treatment~     in AECOPD in China.~   "
76879|NCT02051153|"~     This project aims to investigate the effect of modafinil on motivation, creativity,~     cognitive performance, and subjective wellbeing in healthy participants. The main task for~     this research project is to address how this novel stimulant acutely influences motivation,~     divergent and convergent thinking, cognitive performance and subjective wellbeing in~     non-sleep deprived healthy young adults.This is a randomised between-subjects parallel group~     design study.~      Based on the hypothesis that psychostimulants might enhance creativity through the increase~     in of dopamine and executive planning in healthy adults , we predict that healthy~     individuals who are in the modafinil condition will perform better in the motivation,~     creativity, and the cognitive performance tasks. Furthermore, based on the evidence that~     modafinil increases dopamine in the nucleus accumbens, putamen and the caudate, we expect~     specific subjective well-being and pleasure enhancement associated with modafinil use in~     healthy young adults.~   "
76880|NCT02051140|"~     This study is being conducted to assess the effect of dietary strawberry supplementation on~     cognition and mobility in older adults. It is hypothesized that plant compounds, present in~     strawberries, may improve cognition and mobility by protecting against oxidative stress and~     inflammation.~   "
76881|NCT02051127|"~     One of the biggest challenges of today is the high stress levels among employees in~     companies and organizations. Physical exercise may be an effective preventive measure for~     stress-related problems. This relatively simple and inexpensive action is believed to be~     important for increasing and maintaining work ability and reduce the cost of stress-related~     ill health in the workplace.~      The aim is to investigate how regular physical exercise affects the individual's ability to~     mentally and physiologically cope with stress. Acute stress physiological responses are~     measured before and after a 6 -month intervention, where 100 untrained individuals are~     randomized to either regular physical exercise or a control group.~      The hypothesis is that exercise leads to lesser activation of the individual's stress~     physiological systems and to an efficient physiological protection system. Mental ability to~     handle stress is also studied as well as possible effects on the brain's cognitive~     functions. From a work perspective, cognitive impairment due to high exposure to stress is a~     major problem leading to substantial costs in businesses and organizations as a result of~     reduced performance and production.~      We believe that physical activity can alter and mitigate individual stress reactions. This~     study brings new knowledge that can contribute to increased motivation to prioritize~     physical activity in everyday life. The study could also provide evidence for businesses and~     organizations of the benefits of engaging in interventions and fitness initiatives to~     facilitate/enable increased physical activity in daily life for its employees. With an aging~     population, we are expected to work longer, which poses a challenge as the ability to manage~     stress and maintain cognitive abilities decline with age. For older employees, regular~     physical activity could be an important factor directly affecting the prospects for a~     sustainable working life.~   "
76882|NCT02051114|"~     Longitudinal study of patients with rheumatoid arthritis comparing measures of disease~     activity with blood samples.~   "
76883|NCT02051101|"~     The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain,~     collect biopsy samples and blood samples to characterize exosomes and metabolites from Port~     Wine Stain.~   "
77920|NCT02037477|"~     The purpose of this study is to investigate the acid-inhibitory effect of multiple oral~     doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls~     (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the~     CYP2C19 extensive metabolizer (EM) genotype.~   "
76884|NCT02051088|"~     Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to~     stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest~     pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk~     of amputation, to exercise-induced pain (intermittent claudication), limiting the patients~     daily activities. Invasive treatments are often indicated to prevent amputations and to~     alleviate symptoms. More than two thirds of these procedures are presently performed with~     endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without~     stent implantation).~      In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents,~     DES) reduce restenosis and improve clinical results for the majority of patients. Drug~     eluting balloons (DEB) are a promising alternative, but there is still little evidence that~     DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing~     these new technologies in PAD have been reported in a few studies.~      In this trial, we test the hypothesis that drug eluting (DE) technology is superior to~     conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when~     applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular~     lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each~     defined by the severity of peripheral arterial disease. Patients with critical limb ischemia~     are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to~     SWEDEPAD 2.~   "
76885|NCT02051075|"~     Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is~     usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However,~     fertilization rate with this method is still lower compared with ICSI using motile sperm.~     One of the reasons for that is the immotile sperm inability to activate the oocyte Our~     research hypothesis is that better fertilization rate can be accomplished in these cases by~     combining PXN sperm activation with Ca ionophore oocyte activation.~   "
76886|NCT02051062|"~     The purpose of this study is to verify the pediatric dosing recommendations for BAT® in~     pediatric patients that are treated with BAT® due to a confirmed or suspected case of~     botulism. One 5 mL blood sample will be obtained within 24 hours post BAT® administration.~     Study BT-011 will be run concurrently with the BAT patient registry (BT-010).~   "
76887|NCT02051049|"~     The purpose of this study is to assess the long-term safety follow-up of patients having~     been treated with HepaStem.~   "
76888|NCT02051036|"~     This study aims to explore the feasibility of moxibustion as a supplementary intervention~     and to assess the sample size for verifying the effectiveness and safety of integrative~     treatment involving moxibustion compared with conventional treatment for patients with~     benign prostate hyperplasia (BPH) accompanying moderate to severe lower urinary tract~     symptoms (LUTS).~   "
76889|NCT02051023|"~     Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days~     is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates~     the worsening of the disease after exposure to an adverse controlled environment.~   "
76890|NCT02051010|"~     The study will follow a descriptive design involving a survey. Data collection will involve~     paper based questionnaires. The questionnaires have been developed in conjunction with~     breast cancer support groups associated with the Irish Cancer Society and patients.~   "
76891|NCT02050997|"~     This is an exploratory, translational, non-interventional and multi-centre clinical study.~     The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy~     in PDAC.~   "
76892|NCT02050984|"~     Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of~     at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions~     such as diabetes. A variety of studies showed that it cause significant weight loss,~     recovery from diabetes and improvement in cardiovascular risk factors, such as blood~     pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with~     co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in~     Chinese has lower BMI than that in west country. Therefore, this research is designed to~     observe whether bariatric surgery reduce blood pressure in patients with diabetes and~     relatively lower BMI.~   "
76893|NCT02050971|"~     The purpose of this study is to test the safety and effectiveness of a whole own~     (autologous) umbilical cord blood transfusion in the first 5 days after birth if the baby is~     born premature <34 weeks and developed anemia of prematurity.~   "
76894|NCT02050958|"~     Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 -~     the study drug) which it is proposed will have less of the side effects than are currently~     reported with standard prescription strength Ibuprofen.~      This study will compare the study drug to an already marketed formulation of prescription~     strength Ibuprofen (the reference product) by looking at how the drug is taken up by the~     body and also by performing a specialist procedure called an endoscopy (or more specifically~     a gastroscopy). The safety and tolerability of the study drug will also be assessed.~      The study will involve approximately 44 healthy male and female subjects. Subjects will be~     randomly assigned to receive either the study drug or reference product for 8 days. On Day~     1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will~     receive 800 mg ibuprofen three times a day.~   "
76895|NCT02050945|"~     The purpose of the present project is to investigate the physiological effects of two~     different types of exercise training in COPD patients. The patients will be examined before,~     during and after 8 weeks of training to evaluate the effect of different types of skeletal~     muscle stimulation on health related quality of life, 6 min walking distance, flow mediated~     dilation, and histological properties of skeletal muscle cells, regarding oxidative~     capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The~     study will test the hypothesis that:~      Resistance training is superior to endurance training in patients with COPD~   "
76907|NCT02050789|"~     Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to~     debate how best to (re)structure postgraduate medical education.~      There is concern that current restrictions may be detrimental to patient care and resident~     training. To investigate these issues, the investigators will be conducting a one-year,~     prospective randomized trial to examine how flexibility of duty hour requirements affects~     patient care when compared to current resident duty hour requirements. Further information~     about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.~   "
76896|NCT02050932|"~     Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron~     deficiency anemia. However, absorption of OIS is often low and response is variable. To~     overcome this, large doses are given but this may reduce compliance due to gastric~     irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum~     hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte~     iron utilization. Based on limited data in humans, SHep can be increased by a single OIS~     dose but the duration of the increase is uncertain: In a recent study conducted in our~     laboratory it has been found to last approx. 24 h. Also, there are few data on how the~     increase in SHep determines the absorption of further doses of oral iron. Is there a~     threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding~     of this relationship would be valuable to design more effective and safer OIS regimens.~      Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect~     hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron~     supplement dosages given at different times of the day (Study 2).~      Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic~     subjects will be excluded from the study. Thirty two subjects will be included with serum~     ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be~     randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day~     1 (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron~     isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will~     be collected to monitor sHep and iron status markers.~      Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for~     better understanding of the iron-hepcidin relationship and this may enable design of more~     effective OIS regimens.~   "
76897|NCT02050919|"~     This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation~     therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue~     sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride~     and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination~     chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue~     sarcoma.~   "
76898|NCT02050906|"~     This randomized pilot clinical trial studies intensive diet and exercise or standard of care~     in improving physical function and quality of life in patients with prostate cancer~     undergoing androgen deprivation therapy. Diet and exercise may help improve physical~     function and quality of life in prostate cancer patients. It is not yet known whether~     intensive diet and exercise is more effective than standard of care in improving physical~     function and quality of life in patients with prostate cancer undergoing androgen~     deprivation therapy.~   "
76899|NCT02050893|"~     Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid~     responsiveness has significance in volume resuscitation for septic shock patients. As the~     sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness~     for the pharmacological effect of venodilation. However, the hypothesis has not been~     certified clinically. In this research, the investigators aim to test the hypothesis that~     Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock~     patients.~   "
76900|NCT02050880|"~     The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance~     to the RS-3000, assess the crossed precision of each study device and to assess the~     transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000~     Advance.~   "
76901|NCT02050867|"~     Physicians and nurses working in non-mental health settings require tools to guide them in~     recognizing patients at risk. While screening children and adolescents is emerging as a~     priority of the Joint Commission, there are currently no suicide screening instruments~     designed specifically for assessing suicide risk in a pediatric inpatient medical~     population. Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a~     4-item suicide risk screening instrument with excellent sensitivity, specificity, and~     negative predictive value for use in pediatric emergency departments (Protocol #08-M-N070).~     However, use of the ASQ in an inpatient medical setting has not been tested. The aim of this~     study is to determine the utility of the ASQ among pediatric medical inpatients in children~     s hospitals. While most inpatients will not be at imminent risk for suicide, we hypothesize~     that the ASQ will capture a number of patients who screen positive and are not only at risk~     for suicidal behavior in the future, but are also experiencing significant emotional~     distress and therefore warrant further psychiatric evaluation and follow-up treatment. This~     will be a multisite study, comprised of medically ill inpatients at three non-NIH affiliated~     sites (Children s National Medical Center, Boston Children s Hospital, and Nationwide~     Children s Hospital), with a total sample size of 600 (200 per site). We will administer~     several short measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief~     depression screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all~     eligible inpatients aged 10-21 years. The ultimate goal of this project is to provide~     non-mental health clinicians with a brief, accurate assessment tool for detecting risk of~     suicide in pediatric medical inpatients and in turn, connecting those in need with mental~     health services. After validating the ASQ with pediatric medical inpatients, we will then~     examine the practical implications of nurses administering the ASQ as standard of care~     during the admission process on a pediatric medical inpatient unit. Future studies will~     focus on validating the ASQ in non-English speaking patients, addressing a critical gap in~     suicide prevention research. In addition, examining the long-term clinical impact of~     screening general medical patients for suicide risk with the ASQ and linking those in need~     with mental health services and/or other interventions will be important next steps.~      Please note: This is a multi-site study that is being conducted at three non-NIH sites, all~     children s hospitals, two of which have already received IRB approval (Boston Children s~     Hospital and Children s National Medical Center) and one which is in the process of~     submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the~     Clinical Center. Consent and patient data collection will take place on inpatient medical~     units at those three sites; data will be sent to NIMH, and stored and analyzed here.~   "
76902|NCT02050854|"~     The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects~     with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are~     currently on treatment with oral aripiprazole.~   "
76903|NCT02050841|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of~     octaplas in pediatric patients who require replacement of multiple coagulation factors.~     Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies~     due to liver disease and in pediatric patients requiring cardiac surgery or liver surgery.~   "
76904|NCT02050828|"~     The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as~     daily subcutaneous injections with and without monthly intravitreal injections of~     ranibizumab for 3 months in patients with diabetic macular edema.~   "
76905|NCT02050815|"~     This study is a phase I, multi-center, open-label, single oral dose, parallel group study to~     assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy~     subjects with normal hepatic function. Subjects will be assigned by hepatic function defined~     by elevation of serum total bilirubin and serum AST as determined at the screening and~     baseline visits. The study population will be healthy male and postmenopausal or sterile~     female subjects who meet all of the inclusion and none of the exclusion criteria. A minimum~     of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group~     1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment~     and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be~     confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety~     assessments, labs and PK will be assessed.~   "
76909|NCT02050763|"~     Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few~     interventions combining HIV and IPV prevention have been evaluated and none has~     significantly decreased both outcomes.~      A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters~     (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone~     (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by~     Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard~     of care HIV services alone.~      Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study~     between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV~     and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex,~     number of total and extra-marital sex partners, alcohol use surrounding sex, condom use,~     discussion about condom use, partner's disclosure of HIV status and respondent's disclosure~     of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to~     estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and~     secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of~     HIV acquisition per 100 person years (py).~      Our study had three research aims and related hypotheses.~      Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization~     from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the~     impact of RHSP community services alone.~      Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in~     intervention vs. control arms.~      Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in~     intervention vs. control arms.~      Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors~     among men and women compared to the impact of RHSP community services alone.~      Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the~     intervention vs. control arms.~      Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the~     impact of RHSP community services alone.~      Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.~   "
76910|NCT02050750|"~     This is an exploratory, translational, non-interventional and multi-centre biobank. The aim~     of the development of such a biobank is to identify potential biomarkers that are indicative~     of disease relapse.~   "
76911|NCT02050737|"~     This is an exploratory, translational, non-interventional and multi-centre clinical study.~   "
76912|NCT02050724|"~     Title ThoHSpEkt~      Study Design Pilot Study concerning the technical operative methods and a phase II study~     concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a~     new indication)~      Location Kantonsspital St.Gallen~      Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules~     with the help of free-hand SPECT.~      Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be~     operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule~     is not possible a switch to minithoracotomy is performed.~      Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided~     surgery~      Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)~      Rational for patient number 10 patients for each group are enough to prove the feasibility,~     to manage difficulties and to record complications~      Duration approximately 24 months.~   "
76913|NCT02050711|"~     The effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary~     disease (COPD) has been based on systemic outcome measures, however, little is known about~     the effectiveness of this intervention on patients' lung function. The forced expiratory~     volume in one second (FEV1), despite of being the gold standard for assessing lung function~     in COPD, is poorly responsive to pulmonary rehabilitation. Thus, an objective and responsive~     outcome measure to assess the effect of pulmonary rehabilitation on lung function is needed.~      Computerized respiratory sounds have been found to be a more sensitive indicator, detecting~     and characterizing the severity of respiratory diseases before any other measure, however~     its potential to detect changes after pulmonary rehabilitation has never been explored.~     Therefore, this study aims to assess the effects of pulmonary rehabilitation on the~     characteristics of computerized respiratory sounds in patients with COPD.~      A randomized controlled study with one group undergoing pulmonary rehabilitation (n=25) and~     other group receiving standard care (n=25) will be conducted. The pulmonary rehabilitation~     program will included exercise training (3*week) and psychoeducation (1*week).~      Computerized respiratory sounds, lung function, exercise capacity, quadriceps muscle~     strength, health-related quality of life and health services use will be assessed in both~     groups, at baseline, immediately post-intervention and at follow-ups (3 and 6 months after~     PR).~      Descriptive and inferential statistics will be used.~      It is expected that significant changes occur on the characteristics of computerized~     respiratory sounds in patients enrolled in the pulmonary rehabilitation group, in comparison~     with patients receiving standard care. Thus, computerized respiratory sounds could provide a~     simple, objective and non-invasive measure to assess lung function changes after pulmonary~     rehabilitation.~   "
76914|NCT02050698|"~     Fifth metatarsal avulsion fractures are common and can usually be treated conservatively.~     Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast~     walking boot, or below-knee walking cast have been successful. Several papers reported that~     early rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in~     early return to activities. However, early motion of the ankle joint may have the risk of~     displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole~     shoe for protected weightbearing and allowing motion of the ankle joint had successful~     results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth~     metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully~     and that the results were similar between the two. However, this was not a randomized~     controlled trial.~      Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used~     for the treatment. However, we decided to compare results of hard-soled shoe and short leg~     walking cast for the treatment of a fifth metatarsal avulsion fracture.~      We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a~     fifth metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe~     is not inferior to protected weightbearing in a short leg walking cast but is superior to~     short leg walking cast with respect to time to return to normal daily life and patient's~     satisfaction.~   "
76915|NCT02050685|"~     Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the~     results of a polysomnography (PSG). The different screening score studied are: STOP-BANG,~     DES-OSA, P-SAP and OSA50.~   "
76916|NCT02050672|"~     In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI)~     treatment is able to improve IVF outcomes.~      In particular, retrieved oocytes will be randomly divided in two groups, one group will be~     inseminated with MI treated semen while the other will be inseminated with untreated semen.~   "
76917|NCT02050659|"~     In patients with gastric cancer, traditionally a complete omentectomy is performed as part~     of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases~     operation time significantly, especially in laparoscopic procedures. Patients remain more~     vulnerable for peritoneal infections and intestinal adhesions following omentectomy.~     Furthermore one can debate whether a complete omentectomy is indicated from an oncologic~     viewpoint. In the present study we prospectively evaluated the presence of tumor load in the~     greater omentum of patients with potentially curative gastric cancer.~   "
76918|NCT02050646|"~     The purpose of this study is to determine whether a salt restriction diet improves immune~     parameters in patients with autoimmune hepatitis.~   "
76919|NCT02050633|"~     The objective of the protocol is to pursue the long-term follow-up of a large cohort of~     severe traumatic brain injury patients. This outcome is to be described in terms of~     activity, participation, quality of life, socio-professional outcome, economical~     consequences and impact on caregivers, and in relation to health care provision.~      Secondary objectives are to measure the impact on outcome of several predictive factors; to~     evaluate evolution of patients since the last (four-year) evaluation.~   "
76921|NCT02050607|"~     Obesity is associated with changes in the composition and metabolic function of the gut~     microbiota. Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or~     fecal infusion, refers to the process of injecting a liquid suspension of stool from a~     healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease.~     However, since the recently established concept of human gut microbiome and its significant~     role in health and disease has caught on in the medical scientific world, this procedure has~     gained a great pathophysiological strength, meaning not only the simple infusion of stools,~     but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a~     recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity~     in patients with metabolic syndrome.~      Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle~     changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients~     with metabolic syndrome.~      All the patients with metabolic syndrome will receive lifestyle counselling (1400~     kilocalories diet and physical activity encouragement), than will be randomized to FMT from~     healthy lean donors by upper endoscopy (group A) or no treatment (group B)~   "
76922|NCT02050594|"~     The primary objective of the protocol is to identify and describe observed adverse events~     (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study~     period~   "
76923|NCT02050581|"~     In this prospective and retrospective chart review, investigators will evaluate the response~     rates and duration of response for patients with relapsed and refractory idiopathic~     thrombocytopenic purpura (ITP) who have been treated with rituximab and repeated courses of~     dexamethasone. Investigators will also evaluate observed toxicities of the combination, and~     characteristics associated with response.~   "
76924|NCT02050568|"~     Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure~     reflectometry (UPR), for measurements of pressure and cross-sectional area in the female~     urethra. UPR has been able to separate continent women from women with stress urinary~     incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The~     method stands alone in its field.~      9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is~     characterized by a portion of the vaginal canal protruding from the opening of the vagina).~     However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with~     preoperative SUI actually experience an improvement in their condition. Efforts have been~     made to predict the likelihood of a patient having SUI after genital prolapse surgery;~     however the tests have shown disappointing positive and negative predictive values.~      A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital~     prolapse surgery, some clinics choose to treat all their patients with a sling,~     simultaneously. However, not all patients with SUI require surgery and the sling is~     associated with some risks, such as bleeding and bladder injury. There is no international~     consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery.~     Thus, there is great need for knowledge and know-how regarding the mechanism of continence~     in women with genital prolapse, before and after surgery.~      The hypothesis is that UPR may be used to uncover the changes in the female urethra before~     and after genital prolapse surgery, revealing significant differences in the parameters in~     women who develop SUI after surgery. UPR may become an important tool in the preoperative~     assessment, helping clinicians give better information and guidance to their patients.~   "
76925|NCT02050555|"~     This study is designed to evaluate the effect of koji-extracted beverage fermented with~     Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.~   "
76926|NCT02050542|"~     The purpose of the study is to show that 3 targeted biopsies on the suspicious image~     detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system,~     will get no lower rate of cancer detection than those obtained by 12 systematic transrectal~     ultrasound-guided biopsies of the prostate.~   "
76927|NCT02050529|"~     Severe Hypertension in pregnancy demands urgent treatment because of high mortality &~     morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden~     hypotension and tachycardia. Labetalol because of combined α and β blocking effects lacks~     these side effects. Cochrane systematic review could include only three trials of comparison~     of hydralazine with labetalol. All three had sample size ranging from 20-60 obstetric,~     including 19-30 pregnant women. This review could not conclude about comparative effects due~     to insufficient data and suggested that further trials should compare hydralazine with~     nifedipine or labetalol, and to report severe persistent hypertension and adverse~     feto-maternal effects.~      OBJECTIVES:1) To compare efficacy of labetalol versus hydralazine for control of pregnancy~     related severe hypertension.2) To compare adverse maternal and fetal effects of the two~     drugs.~      3) Furthermore, to develop risk assessment model for response to treatment, in terms of~     patient and disease characteristics.~      STUDY DESIGN: Randomized controlled trial.~      SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi over a period of 1~     year.~      METHODS: Total one hundred eighty patients with, severe hypertension(systolic blood~     pressure(SBP)≥160 and/or diastolic blood pressure(DBP) ≥110 mm Hg) at greater than 28 weeks~     of pregnancy or upto72 hours after delivery, will be enrolled. In each group 90 patients~     will be allocated to intravenous labetalol or hydralazine using simple random sampling.~     Primary outcome measures will be lowering of SBP to <160 mm Hg and DBP <110 mm Hg and severe~     persistent hypertension. In addition maternal hypotension, tachycardia, bradycardia, adverse~     effect on fetal heart, still birth and neonatal bradycardia will be measured.~      EXPECTED OUTCOME: Efficacy and side effects of labetalol against hydralazine, in our~     population will be determined. Assessment model for response to treatment, will help in~     choosing a drug with better efficacy and minimal side effect profile for different patient~     and disease profiles.~   "
76928|NCT02050516|"~     Does group culture using micro-well group culture dishes improve human blastocyst~     development compared to single embryo culture?~   "
76929|NCT02050503|"~     An open-label, non-randomized study to assess the titration, safety and efficacy of~     intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain~     secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid~     therapy for chronic pain.~      Study objectives include assessment of breakthrough pain episodes related with food intake~     in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck~     tumors~   "
76930|NCT02050490|"~     This study investigates whether the implementation of a symptom diary for reporting and~     communicating chemotherapy-related symptoms improves symptom care and decreases symptom~     burden in adult patients treated with chemotherapy.~      The hypothesis is studied using a before-and-after design. First, symptom care and symptom~     burden will be observed in a sample of patients not being offered a symptom diary. Next, the~     symptom diary will be implemented at the participating hospital and symptom care and symptom~     burden will now be observed in a new sample of chemotherapy patients.~   "
76931|NCT02050477|"~     Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a~     prospective study of 100 patients~   "
76951|NCT02050113|"~     The purpose of this study is to evaluate the safety and efficacy of custom made devices,~     Zenith t-Branch devices and physician modification of FDA approved off-the-shelf~     endovascular grafts in the treatment of patients with complex abdominal aneurysms,~     aortoiliac aneurysms or thoracoabdominal aneurysms who (1) have anatomy not suitable for~     endovascular repair using grafts currently marketed in the United States,(2) are deemed~     unsafe to wait the required time necessary for commercial endograft manufacturing, and (3)~     are at high risk for open surgical repair.~   "
76932|NCT02050464|"~     The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a~     four-year IT-project funded through the European Union (EU). The project consortium involves~     a total of 21 universities and industrial partners from 10 European countries. The project~     delivers the first patient-specific predictive models for early differential diagnosis of~     dementia and their evolution. An integrated clinical decision support platform will be~     validated / tested by access to a dozen databases of international cross-sectional and~     longitudinal studies. As a part of the VPH-DARE@IT project, a new prospective cohort will be~     collected in Kuopio. This prospective cohort will be used to test further the modeling~     approaches and tools developed by using the retrospective databases.~   "
76933|NCT02050451|"~     The current study is designed to assess the impact of an enriched oral nutritional shake~     (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove~     a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a~     segment of intestine is the standard of care for invasive bladder cancer. This operation has~     a high complication rate and several studies have shown that this may be directly related to~     poor nutrition.~      The investigators believe that patients who consume an enriched nutritional shake before and~     after surgery will improve their nutrition status and experience fewer complications,~     shorter length of stay and less readmissions compared to those who do not.~      Patients who are scheduled to undergo elective radical cystectomy will be eligible for~     enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group~     will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery~     and the other will be offered a daily over-the-counter multivitamin for the same period of~     time. The investigators will follow both groups for up to 30 days after their surgery and~     compare clinical outcomes such as: complication rates, length of stay, readmission rates and~     mortality as well as measure serum markers of nutrition status and assess changes in body~     composition.~   "
76934|NCT02050438|"~     The purpose of this study is to determine whether different kind of prostesis designs~     influences in the quality of life of patients~   "
76935|NCT02050425|"~     Clinical trial in patients with obstructive sleep apnoea that are randomised to either~     continue or withdraw continuous positive airway pressure therapy to identify a~     disease-specific exhaled breath pattern by mass spectrometry.~   "
76936|NCT02050412|"~     Measurement of skin reactivity of cat dander samples obtained by different methods.~      Subjects will be assessed for the study by of a conventional skin prick test with a positive~     (histamine), a positive (standardized cat dander extract) and a negative allergen control (a~     diluent) if they fulfil all other in- and exclusion criteria, too.~      A screening prick test will be performed in order to confirm positivity (cat dander~     allergy).~      A scratch test will be performed in participants after a positive screening prick test, in~     order to measure skin reactivity to cat dander, originating of three different body areas of~     the cat. For this purpose, a small amount of cat fur in solution with distilled water will~     be placed onto the volar aspect of both forearms after the skin has been scratched with a~     scratch lancet. The distilled water in which the cat hair was solved before will serve as~     negative control.~      This procedure will be repeated with fur of the three different areas of the cat, always~     using triplicates (nine samples per cat).~      From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).~   "
76937|NCT02050399|"~     Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart~     responses during exercise or postural maneuver. Thus, the purpose of this study is to~     observe the influence of different postures (supine, seated and standing) and different~     percentages (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in~     the responses of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure~     (DBP), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral~     vascular resistance (PVR) in coronary patients with and without type 2 diabetes.~   "
76938|NCT02050386|"~     This is a study designed to look at how arousal levels in the brain change with age and how~     these changes influence thinking, vision, hearing and physical function in people of~     advanced age.~   "
76939|NCT02050373|"~     The aim of the study was to evaluate the effect of low-level laser therapy (LLLT) on the~     severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory~     cytokines, metalloproteinases and growth factors) levels in saliva and blood of~     hematopoietic stem cell transplantation (HSCT) patients.~   "
76940|NCT02050256|"~     Background: Optimizing the basic palliative care has been shown beneficial to patients in~     end-of-life care, the general practitioner (GP) having a pivotal role in the health care~     system, providing comprehensive and continued medical care.~      The aim of the study is to investigate the effect of a complex intervention in general~     practice on GPs' awareness of and confidence in providing end-of-life care.~      Method: A follow-up study among 404 general practices in Central Denmark Region. The~     participating general practices will get the opportunity to receive education in palliative~     care and access to an electronic support, which provides advice on palliative care and an~     overview of the palliative population in each medical practice. The education and the~     support will focus on patients suffering from either metastatic cancer or chronic~     obstructive pulmonary disease (GOLD stage 4).~      The end-of-life care delivered by the GPs to their deceased patients will be analysed, based~     on questionnaires to GPs and register data related to the deceased patients before and after~     the intervention, .~      Primary outcomes: Place of death of deceased patients, time spent at home, and number of~     hospital admissions in the last three months of the patients' lives.~      Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant~     medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be~     assessed in questionnaires.~   "
76952|NCT02050100|"~     The study goal is to collect blood samples from individuals at risk for lung cancer in order~     to identify protein markers for diagnosis of lung cancer in the Chinese population.~   "
76953|NCT02050087|"~     The study is a prospective randomized controlled non-inferiority trial where we elucidate~     the role of postoperative immobilization after arthroscopic rotator cuff repair.~   "
76954|NCT02050074|"~     Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug~     metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).~   "
76941|NCT02050243|"~     Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas,~     ependymomas, medulloblastomas, and many other pathologies.~      In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while~     preserving neurological function. Extent of tumor residual has been shown to be a major~     prognostic factor for progression free survival (PFS), and survival in several malignant and~     low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors.~      5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of~     various cancers. Following oral admission, during surgery, the tumor tissue is illuminated~     by blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX~     (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This~     enables the surgeon to better identify tumor cells and perform a more extensive resection.~      Over recent years, many studies have proven the efficacy using 5-ALA for resecting various~     intracranial and spinal tumors, thus achieving a better tumor control.~      In the suggested study, we propose using the same technique for various pediatric central~     nervous system tumors.~      We will focus on the correlation between various pathologies and the fluorescence, trying to~     deduce the role of 5-ALA in resection of specific pathologies.~      Also, we will study the safety of 5-ALA use in the pediatric population.~   "
76942|NCT02050230|"~     Transfusion of stored blood has been associated with increased pulmonary vascular resistance~     in lambs. The investigators hypothesize that transfusion of one unit of red blood cells~     stored under standard conditions in intensive care patients will increase pulmonary arterial~     pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh~     red blood cells.~   "
76943|NCT02050217|"~     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the~     machine applies positive pressure throughout inspiration in proportion to the electrical~     activity of the diaphragm (EAdi), Because ventilator functioning and cycling are under~     control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance~     patient-ventilator interaction ensuring synchrony and minimizing the risk of~     over-assistance. Among different interfaces, the pediatric helmet is better tolerated than~     facial or nasal mask, thus requiring less sedation and allowing more prolonged ventilatory~     assistance (5-6).To date, no data exist on the use of NAVA in infants during noninvasive~     ventilation. The aim of this physiological study is to compare patient-ventilator~     interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV) with~     helmet.~   "
76944|NCT02050204|"~     Although the prevalence of family-friendly policies in US workplaces has increased~     dramatically, few have been studied using scientifically sound designs. To address this, the~     NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN~     designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN~     implemented an innovative intervention based on Phase I pilot studies that is designed to~     increase family-supportive supervisor behaviors and employee control over work, and to~     evaluate the intervention using a group randomized experimental design. Customized~     interventions were performed separately in workplaces of two separate corporate partners.~   "
76945|NCT02050191|"~     This study supports the development of a diabetes prevention and control community web~     portal. The portal will feature an innovative personalized impediment profiling tool and~     reward program. The program, Nutrition Navigation on-Line Edge, or NnoLEDGE, will be used~     by community consortiums for weight loss and diabetic health interventions within their~     communities.~      The Specific Aims are:~        1. Recruitment of local community organizations to participate as a community health~          consortium~        2. Development of a comprehensive community health web portal consisting of a web portal,~          impediment profiler, community toolbox, and rewards system~        3. Final evaluation of the system with regard to participants' attitudes and perceptions~          of using NnoLEDGE as a tool for weight control and diabetes prevention to determine~          feasibility.~   "
76946|NCT02050178|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be~     administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and~     gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The~     planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 mg/kg.~   "
76947|NCT02050165|"~     Proposed is a parallel-design randomized controlled trial to compare the effects of~     consuming two types of snacks on a daily basis for a 12-week period on health outcomes, diet~     quality, and self-reported satiety in a group of overweight adults. The types of snacks to~     be studied are KIND snack bars with almonds and typical American snack foods).~   "
76948|NCT02050152|"~     The investigators are conducting a study to investigate the amnestic effects of 2 different~     concentrations of nitrous oxide in children before induction of anesthesia in a prospective~     double-blinded placebo controlled study.~   "
76949|NCT02050139|"~     Over the last decades, peritoneal dialysis has grown worldwide to become one of the most~     common modalities of renal replacement therapy, particularly in developing or newly~     industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil.~     Peritoneal dialysis has been associated with an initial survival benefit compared to~     hemodialysis, although this advantage becomes less apparent over time, likely due to the~     progressive loss of residual renal function and the development of pathological alterations~     of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral~     supplementation may improve residual renal function in peritoneal dialysis patients. This~     finding may have major clinical relevance, as preserving residual renal function in~     peritoneal dialysis patients has been associated with improved survival . Aim of the present~     randomized, double-blind, crossover study is to confirm the preliminary evidence of the~     beneficial effects of antioxidant agents on residual renal function by using the~     L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual~     diuresis.~   "
76950|NCT02050126|"~     Ten (10) adult female subjects that had a caesarean surgery performed.Study will be~     conducted in 1 site.~      Each subject will receive three treatments on one area that was randomly chosen. The other~     area will be left untreated and will serve as a control.~      The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide~     laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar~     untreated scar side.~   "
76955|NCT02050061|"~     Chronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs leading~     to significant impact on the quality of life. There is no study, to our knowledge, has~     attempted to evaluate the impact of compression stockings on all patients with CVI. Our aim~     is to estimate the prevalence of CVI in Qassim Region and to test the effectiveness of~     compression stockings.~   "
76956|NCT02050048|"~     The purpose of this study is to examine whether giving large amounts of intravenous (IV)~     fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis~     (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious~     complication of ERCP. Typically, a small amount of IV fluids are given during this procedure~     (~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will~     reduce the risk of PEP.~   "
76957|NCT02050035|"~     The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise~     training on blood vessel function in Stages 1-4 Chronic Kidney Disease.~   "
76958|NCT02050022|"~     Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that is characterized~     by loss of lung function, leading to breathlessness, poor quality of life, loss in~     productivity, and increased mortality. The World Health Organization estimates that COPD~     will be the third leading cause of death worldwide by 2020, accounting for more than 7~     million deaths annually. COPD patients frequently experience 'lung attacks', during which~     breathlessness, coughing, and sputum production dramatically increase, leading to urgent~     office visits, emergency admissions and hospitalizations. Lung attacks reduce patient~     quality of life and cost the Canadian health care system nearly $4 billion dollars each year~     in direct and indirect costs. Lung attacks can be effectively managed if they are identified~     and treated early, but symptoms of a lung attack often overlap with those of other common~     conditions such as heart failure, pneumonia and even influenza. Because there are no tests~     that can separate lung attacks from these conditions, doctors struggle to accurately~     diagnose lung attacks at an early stage when drugs are most effective. This can lead to a~     delayed or even incorrect diagnosis and inappropriate treatment. This research will address~     this critical need. Our goal is to improve COPD patient care by developing new blood tests~     that will help identify patients who are in the early stages of a lung attack. Doctors will~     be able to use these tests to treat lung attacks at earlier stages than is currently~     possible. These blood tests will enable doctors to personalize management of COPD to meet~     the needs of the individual patient.~      Hypothesis: New biomarker blood tests can be used to better identify and manage patients~     with COPD.~   "
76959|NCT02050009|"~     This phase I trial studies the side effects and best way to give metformin hydrochloride,~     carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or~     primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride,~     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
76960|NCT02049996|"~     The purpose of this study is to to determine if there is a difference in patient related~     outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse~     repair compared to robotic-assisted repair.~      We hypothesize that pain and quality of life following robotic-assisted repair will be~     similar to that following vaginal reconstruction, when performed in conjunction with vaginal~     hysterectomy.~   "
76961|NCT02049983|"~     The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and~     Performance in Laparoscopy.~   "
76962|NCT02049970|"~     the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during~     supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine~     providing prolonged analgesia after surgery.~   "
76963|NCT02049957|"~     This is a phase 1b/2 study of the safety and efficacy of MLN0128 in combination with~     exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal~     growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer that has~     progressed on treatment with everolimus in combination with exemestane or fulvestrant.~   "
76964|NCT02049944|"~     The purpose of this study is to determine whether an increased prophylactic dose (3 grams)~     of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than~     the current established dosing of 2 grams. The tissue and serum concentration values, when~     using an increased prophylactic dose, can then be compared to our pilot study assays in~     hopes of determining an optimal dosing for the obese and morbidly obese populations~     undergoing cesarean delivery.~      A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial~     Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of~     antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in~     the obese and extremely obese populations. The purpose of this research study is to evaluate~     whether in increased dose of antibiotics given before cesarean delivery (3 grams of~     cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum~     (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an~     effect on the levels of antibiotics in the tissues (a group of similar cells).~      This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index~     (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of~     prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.~     Researchers hope to enroll a total of 35 women overall.~   "
76965|NCT02049931|"~     The treatment outcomes in the treatment without brace would be non-inferior to those in use~     of rigid or soft brace.~   "
76966|NCT02049918|"~     Collect de-identified, residual samples to support a clinical trial. Samples may be~     prospectively or retrospectively collected. Overall Study Objective Obtain clinical~     performance data to characterize clinical performance of the Respiratory Viral Panel on the~     GenMark Sample-to-Answer Platform.~   "
76967|NCT02049905|"~     The purpose of this study is to determine the efficacy and safety of aldoxorubicin in~     subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.~   "
76968|NCT02049892|"~     Does having a large diameter metal on polyethylene total hip replacement increase metal ion~     release. Larger metal heads are thought to have increased torsional forces on the trunion~     which would like release more metal ions. Increased metal ion levels have been associated~     with adverse local tissue reactions. Are there any differences comparing these groups to a~     dual mobility type total hip replacement.~   "
76969|NCT02049879|"~     The objective of this study was to objectively measure daily physical activity and~     spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality~     of life, before and six weeks after an intra-articular corticosteroids injection in patients~     suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis~     were recruited. The intra-articular corticosteroid injection was given at the end of the~     second week. Physical activity was objectively measured by an accelerometer worn by the~     participants for eight weeks. In addition, the Western Ontario and McMaster Universities~     Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials~     were completed every two weeks to assess symptoms, quality of life and spatiotemporal~     parameters of gait.~   "
76970|NCT02049866|"~     The purpose of this research study is to evaluate antiresorptive therapy with denosumab~     (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal~     women with idiopathic osteoporosis.~      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,~     A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in~     Premenopausal Women (NCT01440803) may be eligible to participate in the current study, a~     36-month open-label pilot study of denosumab (Prolia®, 60mg SC every 6 months).~      The goals of the study are to estimate the effects of denosumab on central and peripheral,~     as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary~     data to inform the design of a future randomized study. This study presents the first~     opportunity to study the effects of denosumab after TPTD in this unique and severely~     affected group of young women.~      Funding Source - FDA OOPD~   "
76971|NCT02049853|"~     Acute dyspnea is a common chief complaint of patients presenting to the emergency~     department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality~     is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The~     Triple A Initiative Study is designed to improve the coordination of care for patients with~     acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the~     coordination of care starting at the EMS level including point-of-care testing of the~     cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification.~     Treatment deriving from earlier diagnostic clarification will reduce length of stay in the~     hospital, treatment costs and improve patient's outcome.~   "
76972|NCT02049840|"~     This is a prospective, post-market, single arm, multicenter study comparing Baseline data to~     the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence~   "
76973|NCT02049827|"~     Kidney transplantation is the treatment of choice for end stage renal disease (ESRD)~     improving the quantity and quality of life for dialysis patients. Although prolongation of~     graft survival in the short term by preventing the release is observed by immunosuppression~     (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have~     a direct deleterious effect on the kidney transplant , but too weak IS can promote~     rejection, and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV )~     . BK nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal~     function , leading to a loss of the graft followed by a premature return to dialysis in at~     least 50 % of cases. Plasma BKV reactivation was observed mainly during the first year of~     transplantation in 15% of patients and complications annually BKVAN concern about 5 % of~     recipients . Currently , treatment options are very limited , only the decrease in IS shows~     a partially effective when care is early . There is no specific antiviral effective~     treatment of this disease . In addition, there is no way to predict which patients will~     develop BKV reactivation BKVAN despite lower tax.~      The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and~     plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR (~     qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV~     viremia is the direct antiviral immune response quality based primarily on a very effective~     anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte~     activation induced by IS blocks the establishment of T-cell responses anti- BKV in most~     transplant, a very low presence of T lymphocytes is generally observed in these patients~     anti- BKV (LYT - BKV) blood .~      Our preliminary studies have validated in vitro a sensitive test to measure the~     functionality of blood LYT - BKV. This test is used to evaluate the concentration and~     functionality of LYT - BKV present in small volume of blood by measuring their specific~     proliferation after stimulation with peptide cocktails BKV. Proof of concept of the~     feasibility of this test was established on a small series of samples and highlights~     significant differences in lymphocyte anti-BKV different patients.~      Put to good use during the post-transplant follow-up, this type of test can provide the~     clinician with valuable data to assess the quality of anti- BKV T response compared to the~     intensity and type of IS treatment. Early identification of patients at risk of reactivation~     of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response~     and monitoring arrangements at the fair. The objective of this project is to conduct a~     feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T~     response of BKV viremic patients during the first year post- transplant. Immunological data~     will be analyzed in relation to virological data and bioclinical data.~   "
76974|NCT02049814|"~     The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose~     combined with Metformin in patients with type 2 diabetes mellitus (T2DM) by evaluating~     levels of glycosylated hemoglobin.~   "
76975|NCT02049801|"~     This phase I trial studies the MEK inhibitor MEK162 to see if it is safe in patients when~     combined with idarubicin and cytarabine. MEK inhibitor MEK162 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as idarubicin and cytarabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor~     MEK162, cytarabine, and idarubicin may be an effective treatment for acute myeloid leukemia.~   "
76976|NCT02049788|"~     The objective of this study is to compare the effectiveness of a low-GI diet program and a~     standard counseling program in the treatment of obese Thai children.~   "
76977|NCT02049775|"~     Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology,~     characterized by a diffuse confluent mucosal inflammation of the colon starting from the~     rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a~     reliable parameter of disease activity, but microscopic inflammation can persist despite~     normal mucosal findings. Histologically detectable inflammation is associated with a greater~     risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple,~     easily measured biological marker of relapse would be important in guiding the most~     appropriate therapy.~      Recent technological advances in fiber optics, light sources, detectors, and molecular~     biology have stimulated development of numerous optical methods that promise to~     significantly improve our ability to evaluate human epithelium in vivo. These methods,~     collectively termed optical biopsy, are nondestructive in situ assays of mucosal~     histopathology using light that can provide instantaneous tissue assessment. Narrow band~     imaging (NBI) is a novel technique that enhances the diagnostic capability of endoscopes in~     characterising tissues by using filters in a redgreenblue (RGB) sequential illumination~     system. This results in improved mucosal contrast and detail.~      UC always involves the distal colon and activity is usually greatest in rectosigmoid area.~     This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC.~     Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be~     affected by systemic disease and would be acceptable test for patients and physicians.~      We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using~     both white light and NBI endoscopy. These patients will be followed by for one year or until~     they relapse, whichever comes first. The aim of our study is to develop endoscopic~     biomarkers to predict relapse in acute and quiescent UC.~   "
88693|NCT01896349|"~     The purpose of this study is to determine whether combination of antidepressant drugs plus~     interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant~     depression.~   "
76978|NCT02049762|"~     Thus far, no study has evaluated the impact on aspirin in addition to the newer and more~     potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual~     anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population.~      Objective The investigators goal is to examine the effect of aspirin in addition to new~     anti-platelet agent (ticagrelor\prasugrel) on platelet reactivity in comparison with~     placebo, among ACS patients treated percutaneously.~      Design The proposed study is a randomized-controlled, double blind trial, conducted among~     ACS patients treated percutaneously. Eligible patients will recruited during hospitalization~     due to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on~     1:1 basis will take place a month after the index event, at a follow-up visit at the cardiac~     clinic.~      Platelet function and Endothelial function tests will be taken a month after the index~     event, and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to~     open-label aspirin.~      End-points platelet function tests will be compared between aspirin and placebo therapy and~     before and after the cross-over.~   "
76979|NCT02049749|"~     The purpose of this research study is to learn whether or not a brief parenting program~     called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help~     improve behavior problems in children who are 2-6 years old.~   "
76980|NCT02049736|"~     Chronic kidney disease (CKD) and chronic viral hepatitis due to hepatitis B virus (HBV) are~     both major public health problems. Treatment of chronic HBV infection in CKD patients,~     however, is not well defined because of insufficient data from clinical trials. Telbivudine~     is a new antiviral that provides effective and sustained viral suppression in patients with~     compensated chronic hepatitis B infection. Unlike other nucleotide and nucleoside analogues,~     renal toxicity is uncommon in telbivudine, and dosage adjustment is not required in patients~     with mild renal impairment. We propose to conduct an open-label single-arm study to evaluate~     the effect of telbivudine on renal function and proteinuria in patients with chronic HBV~     infection and mild-to-moderate renal impairment. Twenty patients with chronic HBV infection~     and chronic kidney disease (estimated glomerular filtration rate 15 to 60 ml/min) will be~     recruited. They will be treated with telbivudine, with the dosage adjusted according to thei~     renal function, for 5 years. Serum HBV DNA, proteinuria, renal function, and urinary~     inflammatory markers will be monitored.~   "
76981|NCT02049723|"~     -  1. Research topic: How much do patients with GERD know about their own disease in~          Korea? (multicenter survey)~        -  2. Questionnaires for multicenter survey:~             1. Questionnaire 1 - include items for basic characteristics of participant patients~             2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health~               Services Research 2008;8:236 (Prof. Jorgen Urnes)~        -  3. Subjects: patients with GERD in secondary or tertiary hospital~        -  4. Participant institutes: GERD club members, The Korean Society of~          Neurogastroenterology and Motility~   "
76982|NCT02049710|"~     The purpose of this study is to measure the effects of an interactive video on adolescent~     risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the~     other intended to reduce automobile accidents.~   "
76983|NCT02049697|"~     The purpose of this study is to investigate the absorption, metabolic pathways and excretion~     of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg~     (0.5 mg/mL solution) of 14C-JNJ-39823277.~   "
76984|NCT02049684|"~     Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of~     the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears~     can be managed with arthroscopic or keyhole surgery. Very large or massive tears are~     difficult to operate on and often have poor rates of healing. As a result surgeons have~     investigated the use of products to improve the outcome of surgery on massive tears.~      The product that the investigators are currently using to try to improve the outcome of~     surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to~     support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar~     patches have found that recovery is improved and there is a lower rate of postsurgical~     problems. The aim of this study is to look at whether using the patch improves pain and the~     clinical function of the shoulder after surgery. In addition, the investigators would like~     to understand how the patch works. To do this the investigators will scan (take images of)~     the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder~     before and after surgery.~   "
76985|NCT02049671|"~     Large population studies of hypopituitary adults (patients with pituitary gland failure) on~     conventional hormone replacement, but not growth hormone, have an approximate two fold~     increase in death rate (mortality). The vast majority of this excess mortality relates to~     vascular disease. While it is possible that overreplacement with steroids, underreplacement~     with thyroid hormones and sex hormone deficiency contribute, there are increasing data to~     support a role for GH in the cause of the excess vascular risk. Although a number of~     surrogates of vascular risk are described in patients with GH deficiency (GHD), how these~     translate mechanistically into atherothrombotic (blockage of the arteries) disease has not~     been fully elucidated.~      This proposed study will analyse both traditional (body composition, serum lipids, handling~     of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular~     risk/disease. In addition the study will examine 24hr blood pressure, arterial wall~     thickness, clot structure and function, as well as platelet action. Measurements will be~     performed at baseline and will be reassessed after patients have been on a stable dose of GH~     replacement for at least three months.~      The results of the study will characterise risk factors for vascular disease, and take this~     a step further to elucidate how these changes translate mechanistically in to vascular~     damage.~   "
76986|NCT02049658|"~     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy~     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is~     hypothesized that sniff dogs may be used as a tool in identifying cancer patients in the~     high risk population or suspected patients. Trained dogs will sniff serum from participants~     who are suspected to suffer from tumor by their physicians and not yet but will be diagnosed~     by pathological examination.The results will be compared with the outcome of the~     pathological examination.~   "
77921|NCT02037464|"~     The purpose of this study is to determine the chemopreventive properties of capsaicin, the~     active compound in chili peppers, in prostate cancer patients enrolled in the active~     surveillance program or patients scheduled to undergo radical prostatectomy.~   "
76987|NCT02049645|"~     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy~     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is~     hypothesized that sniff dogs may be used as a tool in screening cancer patients in health~     examination. Trained dogs will sniff serum from participants who are attending the annual~     health examination to identify potential or high risk subjects, and the results will be~     compared with the outcome of the traditional health examination, and the high risk subjects~     will be followed periodically for at least five years.~   "
76988|NCT02049632|"~     Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method,~     and several follow-up studies have shown that it is safe to refrain from completion axillary~     clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone~     results in significantly less arm discomfort following the operation.~      However, as a surprisingly low frequency of axillary relapse has been observed in patients~     without any axillary intervention (neither SN biopsy nor axillary clearance), or without~     completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even~     for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show~     any differences in 5-year disease-free survival between patients with SN micrometastases who~     had undergone ALND and those who had not.~      This Swedish multicenter study will include patients with SN micrometastases. These women~     will not undergo ALND but will be registered in a study cohort. The patients will otherwise~     be treated in accordance with the national guidelines and will be clinically followed every~     year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from~     axillary clearance in breast cancer patients with sentinel node micrometastases does not~     impair survival.~   "
76989|NCT02049619|"~     The purpose of this study is to determine whether pharyngeal packs can reduce nausea and~     vomiting in patients undergoing orthognathic surgery.~   "
76990|NCT02049606|"~     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet~     and CENATONE tablet in the treatment of osteoarthritis of the knee.~   "
76991|NCT02049593|"~     This phase I trial studies the side effects and the best dose of poly (adenosine diphosphate~     [ADP]-ribose) polymerase (PARP) inhibitor BMN-673 when given together with temozolomide or~     irinotecan hydrochloride in treating patients with locally advanced or metastatic solid~     tumors. PARP inhibitor BMN-673 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and may help temozolomide and irinotecan hydrochloride work~     better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as~     temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving PARP~     inhibitor BMN-673 with temozolomide or irinotecan hydrochloride may be an effective~     treatment for patients with advanced solid tumors.~   "
76992|NCT02049580|"~     Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC~     regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis~     lymphomas.~   "
76993|NCT02049567|"~     Traditional lenses for cataract patients are monofocal, meaning they offer clear distance~     vision, but that patients must wear eyeglasses or contact lenses in order to see clearly~     things that are close to them, such as a newspaper.~      The FluidVision™ lens that is being tested in this study is designed to allow patients to~     see far objects as clearly as with a regular lens, and also to see near objects more clearly~     than with a regular lens.~   "
76994|NCT02049554|"~     The aims of the intervention are:~        1. Assess the feasibility and effectiveness of preconception health care initiated by~          pediatric clinicians on outcomes including women's access to primary care and~          contraceptive services; contraception and rapid repeat pregnancy rate and~          interpregnancy interval; and women's immunization rate, control of chronic illnesses,~          nutritional status, smoking and substance use, mental health and violence exposure;~          child and family health.~        2. Assess the cost-effectiveness of preconception health care initiated in pediatric~          practices.~      The investigators will evaluate these outcomes with a clinic based trial comparing usual~     care to preconception care intervention.~   "
76995|NCT02049541|"~     This phase I clinical trial studies the side effects and the best dose of~     phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in~     treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor~     BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.~     Some block the ability of cancer to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab~     may be an effective treatment for B-cell lymphoma.~   "
76996|NCT02049528|"~     The study is being conducted to compare how long 2 oral formulations (a reference and a test~     formulation) of CC-122 stays in the body, and whether taking the test formulations with a~     high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in~     the study, one for each formulation and one for the test formulation + meal. The subjects~     will be asked to fast for at least 10 hours before taking the capsule formulations. During~     one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being~     given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment~     sequence which will determine the order in which the subject will receive the reference~     formulation, the test formulation, and the test formulation + high-fat meal. Blood samples~     will be taken at intervals during the study to assess the amount of drug at those time~     points. Blood samples will also be collected at certain time points to determine the levels~     of special proteins that may help explain how CC-122 work.~   "
76997|NCT02049515|"~     A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or~     ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small~     Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145~     or Ofatumumab in Study IPI-145-07.~   "
77033|NCT02049047|"~     Given the high expression of IGF-1R and pAKT proteins in thymoma tissues, able to sensitize~     tumors to mTOR inhibition, and the anticancer activity of the mTOR inhibitors, clinical~     evaluation in thymoma and thymic carcinoma seems to be very interesting.~      Patients will receive continuous treatment with oral everolimus 10 mg once daily.~      Efficacy and safety profile of Everolimus will be evaluated.~   "
76998|NCT02049502|"~     The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and~     effective treatment for people who have Ulcerative Colitis and have had an ileal pouch~     anastomosis.~      Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by~     a person's immune system responding in an unusual way to bacteria normally found in the gut.~     Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are~     different from the gut bacteria in people without ulcerative colitis (UC). Often, people~     with ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the~     way that person's immune system works.~      This study is for people who have had a proctocolectomy with an ileal pouch anastomosis~     (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will~     develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the~     ileal pouch that was created in order to store waste from your intestines. Patients with~     pouchitis are being asked to take part in this study.~      Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it~     has been shown that probiotics are not very helpful once the patient stops taking them. In~     addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation~     (FMT) is being studied as another form of treatment for patients with active pouchitis.~     Fecal microbiota transplantation (FMT) or stool transplant involves receiving a single~     fecal enema from someone who has volunteered to donate their stool.~      There are two purposes of this research study:~        1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for~          patients with ulcerative colitis (UC) associated pouchitis~        2. To study the changes within the bacteria in the gut in patients with pouchitis (before~          and after study treatment) using stool, blood and urine samples~   "
76999|NCT02049489|"~     This study will evaluate a type of immunotherapy in which the patient's immune system will~     be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's~     white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to~     assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be~     collected from blood and cultured to yield autologous DC. The DC will be mixed with purified~     peptides from the CD133 antigen. The DC vaccine will be given back to the patient over~     several months. The goal is to stimulate the patient's immune system to CD133 to kill the~     patient's glioblastoma tumor cells.~   "
77000|NCT02049476|"~     The main purpose of this study is to evaluate whether or not the dexamethasone pellet~     (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the~     treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis~     in which immunosuppressive drug therapy is indicated.~      Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is~     not treated.~      The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy~     is approved by the Food and Drug Administration (FDA) for the treatment of intermediate~     and/or posterior uveitis.~      In this study investigators want to see if using the implant together with systemic~     immunosuppressive drug therapy can result in lower ocular side effect profile but is~     effective enough to replace the use of high-dose systemic corticosteroids in the treatment~     of active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of~     these treatments is important because the kinds of uveitis being studied usually need to be~     treated for many years. This information may help researchers understand uveitis better and~     may suggest ways of improving treatment.~      Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug~     therapy with high-dose corticosteroid is planned may join.~   "
77001|NCT02049463|"~     Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its~     relationship to the vessel disease, and to build a new biomarker about vascular disorder.~      Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the~     spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The~     results will be correlated and comparison to the finding in clinical, carotid Doppler and~     duplex, CTA, MR, and catheter angiography.~      Statistics:~      The significance of difference between parameters was computed using t-tests or paired~     t-test etc. A p value <0.05 is defined as significant.~   "
77002|NCT02049450|"~     Patients with severe thalassemia (thalassemia major) present with severe anemia that~     requires life-long transfusion therapy, spleen enlargement that may lead to increased~     transfusion requirement, and other serious complications as early death, growth retardation,~     bone deformations and iron overload due to blood transfusions. Splenectomy can significantly~     reduce transfusion requirement in thalassemia patients, but it is associated with an~     increased risk of serious complications such as sepsis and thrombosis. Preliminary~     preclinical and clinical data suggest that JAK2 inhibition, by reducing spleen size, may~     improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing~     transfusion requirement and related iron overload.~   "
77003|NCT02049437|"~     The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical~     trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral~     therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)~   "
77004|NCT02049424|"~     Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow~     after post-transplantation cyclophosphamide~   "
77005|NCT02049411|"~     - Cognitive changes are related to aging, affecting the performance of older patients in the~     solution of problems and the execution of tasks.~      This phenomenon has been observed as a decline of neurophysiological domains, especially~     memory, and the velocity of thought.~        -  Anesthesia and surgery performed contributes to its development then, is named~          post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:~             1. Anesthesia and surgery.~             2. The time elapsed after surgery.~             3. The population studied, and the type of cognitive test employed.~        -  The aim of this study is to evaluate the changes around the Short Portable Mental~          Status Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on~          the common conditions of geriatric patients, —comorbid and settings as minor surgery—.~   "
77006|NCT02049398|"~     Background:~      - Normal bacteria and other tiny organisms are found in healthy human mouths. These are~     called oral microbiota. It is unclear exactly how the oral microbiota may affect health. For~     example, if the microbial composition is abnormal, it may lead to mouth conditions like~     periodontitis. Researchers want to study how the microbiota changes over time. This can help~     them plan future disease studies.~      Objectives:~      - To see if and how oral microbiota change over time.~      Eligibility:~      - Forty adult employees of the National Cancer Institute Shady Grove.~      Design:~        -  For 12 hours before the first visit, participants will not eat or drink (except water).~          They will not brush, floss, use mouthwash, chew gum, eat lozenges or candies, smoke~          cigarettes, or chew tobacco.~        -  At the first visit, participants will:~        -  Be given a saliva collector. They will spit 2 mL of saliva into it.~        -  Fill out an online questionnaire.~        -  Every 2 months, participants will visit the clinic and repeat visit 1.~        -  The study ends after 1 year.~      Sponsoring Institute: National Cancer Institute~   "
77007|NCT02049385|"~     Background:~      - Depressed people appear to have problems regulating levels of a brain chemical called~     glutamate than people who are not depressed. The drug diazoxide may help regulate glutamate~     levels in people with depression. Researchers want to know if it can rapidly improve~     depression symptoms. This would help many people with depression, because most medications~     take a long time to work.~      Objectives:~      - To see if diazoxide can quickly improve depressive symptoms in people with~     treatment-resistant major depressive disorder (MDD).~      Eligibility:~      - Adults 18 to 65 years old with MDD, who are currently depressed without psychotic~     features.~      Design:~        -  Participants will be hospitalized for the entire study, 11 13 weeks. They may be~          allowed short leaves. Participants will be interviewed many times during the study.~          They will also fill out questionnaires.~        -  Phase I will last about 4 weeks.~      <TAB>- Participants will be screened with lab tests, and psychiatric and medical history and~     exams.~      <TAB> - Participants will slowly go off current medications. They will be drug-free for 2~     weeks.~        -  Phase II will last about 8 to 9 weeks.~        -  Participants will be monitored, answer questions, and give blood samples. They will~          drink a glucose drink, give saliva samples, and have scans of their brains taken.~        -  Participants will take the study drug daily by mouth for one 3-week session.~        -  They will take a placebo daily by mouth for the other 3-week session.~        -  There will be a drug-free period of 14 to 21 days between sessions.~   "
77008|NCT02049372|"~     Our aim was to establish a feasible method to prospectively register all tonsil~     surgery-related complications and to find their possible predictive factors. Our long-term~     objective is to create a surgical complication registration database, which would provide~     valuable information for quality assurance and give us a benchmarking tool to improve the~     results of this surgery in our department.~   "
77009|NCT02049359|"~     The purpose of this study is to determine the impact of two-way short message service (SMS)~     on glycemic control in low-income, poorly-controlled adult diabetic patients.~   "
77010|NCT02049346|"~     * Background: Despite extensive use, to the best of our knowledge, no trial has~     simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in~     a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.~      * Patients and Methods: All haemodialysis patients in Qatar who were treated with short~     acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to~     continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous~     erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were~     assessed at the end of the study for safety and efficacy parameters.~   "
77011|NCT02049333|"~     The purpose of this study is to assess and compare the mechanical angle opening in patients~     with angle closure due to a plateau iris configuration (elevated iris) using~     phacoemulsification combined with endoscopic cycloplasty versus treatment with~     phacoemulsification alone.~   "
77012|NCT02049320|"~     This is a descriptive retrospective study designed to measure the efficacy of remifentanil~     sedation and the ability to perform frequent neurological examinations of patients with~     traumatic brain injuries.~   "
77013|NCT02049307|"~     The purpose of this study is to evaluate the potential effectiveness of losartan (100mg~     daily) for reducing inflammation and improving immune recovery.~   "
77014|NCT02049294|"~     The purpose of this study is to investigate whether addition of Omalizumab enables a~     reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.~      This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial~     divided into two sequential study periods.~      Period 1: After establishing the minimum dose of prednisone to maintain asthma control and~     maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab~     for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).~      Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a~     clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients~     have an exacerbation, they will be treated with prednisone. This patient will continue on~     Omalizumab or placebo during the entire duration of the study but not continue the phase of~     steroid reduction.~   "
77015|NCT02049281|"~     This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable~     dose. The primary study hypothesis is that administration of vintafolide to participants~     with advanced solid tumors will have acceptable safety and tolerability.~   "
77016|NCT02049268|"~     Nicotine and alcohol are frequently used together and their combined use contributes to more~     than half a million deaths each year, with more alcoholics dying from smoking-related~     diseases than from alcohol-related diseases. Using a new multi-modal MRI approach combined~     with data fusion, the investigators propose to study how nicotine modulates alcohol-induced~     changes in the function of brain circuits. The investigators hypotheses are:~        -  functional connectivity (FC) in the reward network, containing components of the~          mesolimbic dopamine system, will be altered by alcohol, and additional increases in FC~          will be observed if nicotine is also present (e.g., additive effects).~        -  co-administration of nicotine will counteract the effects of alcohol on FC in multiple~          brain networks, including visual, sensorimotor and motor brain circuits, that may be~          associated with the impairing effects of alcohol~   "
77017|NCT02049255|"~     Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical~     correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months)~     pain.~   "
77018|NCT02049242|"~     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss~     at open myomectomy.~   "
77019|NCT02049229|"~     The purpose of the prospective, randomized and a multicenter trial is to compare clinical~     outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus~     Synergy-EES.~      Second objective is to explore whether the Optimax-BAS use is superior compared with~     Synergy-EES use with respect of hard end points (cardiac death, MI and major bleeding).~   "
77043|NCT02048917|"~     The purpose of this study is to find an optimal smoking cessation strategy in patients~     undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky~     by delivering high quality smoking cessation to all enrolled patients. This study will also~     examine the feasibility of routinely implementing an array of smoking cessation strategies~     for this patient population.~   "
77020|NCT02049216|"~     People with osteoarthritis (OA) of the knee attending The Alfred hospital will be invited to~     participate in a randomised controlled trial comparing two different types of knee taping.~     Both groups will also be prescribed an exercise program to assist in management of their~     knee OA.~      Hypothesis are as follows:~        1. Participants treated with flexible tape with have greater reductions in pain and~          improvements on timed performance based measures when compared to those treated with a~          placebo tape.~        2. Participants in both groups will have clinically significant improvements in pain and~          timed performance based measures compared to their baseline scores.~   "
77021|NCT02049203|"~     This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with~     mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be~     on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without~     passing out), and determining whether treatment with Ataciguat results in significant~     reductions in blood pressure in this patient population.~   "
77022|NCT02049190|"~     This is an open-label, randomized, parallel group two-stage phase 1-2 study with an~     escalation and an expansion component. This study will evaluate an extended-release (ER)~     formulation of onapristone in patients with prostate cancer in which Progesterone Receptor~     (PR) may be contributing to tumor progression. A companion diagnostic to select patients~     whose prostate cancer expresses the activated form of the PR (APR) is under development and~     will be implemented in this study; it may be used to further enrich the selection of the~     population based upon ongoing review of the results. Patients will be treated until~     occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw,~     or for non-compliance with either protocol-specified evaluations or onapristone treatment.~     An additional cohort of patients will be included at the recommended phase 2 dose to gain~     additional understanding of the onapristone safety profile and potential anti-cancer~     activity.~   "
77023|NCT02049177|"~     Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important~     questions remain however, regarding the role of specific types of HPV, their effect on~     prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with~     other risk factors (such as smoking and alcohol), and potential geographical differences in~     the effect of HPV.~      Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which~     is an international collaboartive case-control study conducted in 15 centres in 11 European~     countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a~     systematic analysis of HPV subtypes known or suspected to be involved in head and neck~     cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx,~     hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by~     exposure to other known or suspected carcinogens including tobacco, alcohol and medical~     history.~      It is intended that this work will contribute to the development of evidence that may feed~     into treatment protocols for these cancers as well as evaluations of the feasibility for~     extending HPV vaccine programs.~   "
77024|NCT02049164|"~     The purpose of this study is to determine the effective dose or dose range of AR08 in the~     treatment of VMS in menopausal females.~   "
77025|NCT02049151|"~     This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in~     subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have~     demonstrated either stable disease or objective response following primary concurrent~     chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with~     tecemotide versus subjects treated with tecemotide-matching placebo.~   "
77026|NCT02049138|"~     This is a Phase 2, multicenter, open-label extension study in RA subjects.~   "
77027|NCT02049125|"~     The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase~     associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict~     acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and~     to predict response to AKI treatment with albumin and albumin with terlipressin in patients~     with suspected hepatorenal syndrome.~   "
77028|NCT02049112|"~     The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of~     our new oral salivary equivalent in the relief of signs and symptoms related to mouth~     dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal®~     & Biotene®) in patients with xerostomia due to chronic hyposalivation.~   "
77029|NCT02049099|"~     To describe the current treatment practice during 12 months for previously treated patients~     diagnosed with haemophilia A or haemophilia B.~   "
77030|NCT02049086|"~     This proposal will develop and test an indicated prevention strategy, Screening, Brief~     Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM), in Veterans~     who have filed a claim for a (military) service-connected injury for which they have~     requested financial compensation. Although typically only an information-gathering,~     forensic-styled examination, the Compensation examination is a crucial point of entry to VA~     care. Objectives are:~        1. To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of~          this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their~          musculoskeletal conditions and their Compensation claims; and (2) finalizing the~          counseling materials and procedures.~        2. To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a~          pain module only arm.~   "
77031|NCT02049073|"~     Noise-induced hearing loss affects an estimated 5% of the worldwide population, with 30-40~     million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may~     be occupational, blast noise, or recreational. Trauma to the inner ear can occur through~     transient hearing loss or permanent hearing loss. Although hearing recovers after temporary~     transient hearing loss, growing evidence suggests that repeated temporary transient hearing~     loss may lead to a permanent hearing loss. Currently, there are no treatments and there are~     no known medications that can be used clinically to prevent noise-induced hearing loss in~     humans.~      The long-term goal of this research is to find medications that can prevent noise-induced~     hearing loss. The purpose of the present pilot study is to evaluate zonisamide and~     methylprednisolone as medications to prevent temporary transient hearing loss in humans.~   "
77032|NCT02049060|"~     This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in~     combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced~     or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their~     specific therapy.~   "
77034|NCT02049034|"~     Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which~     have recently been shown to have beneficial effects on weight, glycaemic control and~     postprandial triglyceride concentrations. Postprandial hypertriglyceridaemia, which is~     associated with an increased risk of cardiovascular disease, is a feature of type 2~     diabetes. Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which~     consist of very low-density lipoproteins, (VLDL) synthesised by the liver which contain the~     higher molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are~     synthesised in the intestine in response to an intake of dietary fat and contain the lower~     molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor~     signalling is required for the control of postprandial lipoprotein synthesis and secretion~     in hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1~     receptor antagonist increased apoB-48 TRL production.~      This study will investigate the effect of the GLP-1 analogue lixisenatide compared with~     placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12~     patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be~     measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling~     triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid~     meal will also be investigated using stable isotope methodology. Gastric emptying and post~     heparin LPL activity will be measured.~      The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease~     in endogenous glucose output and an increase in glucose clearance by peripheral tissues as a~     result of an improvement in insulin sensitivity.~   "
77035|NCT02049021|"~     Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still~     do not respond properly to antipsychotic therapy. These patients are considered~     treatment-resistant or refractory, and the best choice for them is clozapine. However, even~     supported by the literature as the best known antipsychotic in terms of efficacy and rates~     of response, a considerable number of patients will still not respond to this treatment,~     remaining symptomatic and dysfunctional. These patients are classified as super-refractory~     (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have~     been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and~     electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion~     has been drawn.~      Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to~     clozapine-resistant patients, as compared to placebo (sham ECT).~      Methods: This is a pilot double blind, placebo controlled and randomized study to assess~     electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory~     schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or~     4000Q device, and the procedure is under general anesthesia and monitorization, after~     informed consent. The Hospital will follow national protocols and regulations on ECT. Sham~     ECT consists in habitual patient preparation and sedation, without stimulation. Patients~     that fit inclusion criteria will have their clozapine blood levels dosed and undergo~     structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT~     sessions (thrice a week protocol). The assessments will be based on CGI (Clinical Global~     Impression) and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be~     maintained, except lithium carbonate.~   "
77036|NCT02049008|"~     The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians,~     because there are no standardized protocols for efficient control of the disease. The aim of~     this study is to evaluate the effect of multiple applications of antimicrobial photodynamic~     therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients~     diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a~     split-mouth design study to either aPDT associated with scaling and root planning (SRP) or~     SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength~     associated with a phenothiazine photosensitizer. The applications will occur in four~     episodes (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical~     assessment of plaque index, probing depth, clinical attachment level and bleeding on probing~     will be performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT.~     Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT)~     and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard~     hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30~     and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of~     Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained~     will be statistically analyzed.~   "
77037|NCT02048995|"~     Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still~     lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and~     limited, and clinical decision making is less refined. Currently, the investigators are~     investigating the effects of midday bright light therapy for the treatment of bipolar~     depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar~     Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a~     possible biological mechanism which might explain response to light treatment in depressed~     bipolar patients.~   "
77038|NCT02048982|"~     The purpose of this study is to test whether physicians change their use of non-recommended~     tests, procedures, or medications more in response to evidence based-guidelines, price~     information, or an individual patient's story.~   "
77039|NCT02048969|"~     The purpose of this study is to test feasibility of measuring flumazenil-induced changes in~     cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of~     hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a~     double-blind, placebo-controlled, randomized, cross-over design.~   "
77040|NCT02048956|"~     Knee osteoarthritis is a common condition characterized by pain and functional disability in~     older people. Prevalence increases with age and is more frequent in older women. The aim of~     this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands~     on pain and functional disability in old people with knee osteoarthritis.~   "
77041|NCT02048943|"~     This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel~     albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given~     together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and~     reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel~     albumin-stabilized nanoparticle formulation are anti-cancer drugs for treating many cancer~     types.~   "
77042|NCT02048930|"~     The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the~     Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care~     asthma population of patients aged 6 to 80 years.~   "
82131|NCT01982357|"~     Alterations to microvascular blood flow in premature infants, are known to contribute to~     several major disease entities.~      The optically-measured tissue blood flow, to determine tissue perfusion that can be use to~     detect blood loss.~   "
77044|NCT02048904|"~     The people being asked to participate in this study have type 2 diabetes and abnormal levels~     of protein in their urine. This indicates that they are starting to develop diabetic kidney~     disease. The standard treatment for this is the use of one of two blood pressure medicines,~     either an ACE inhibitor or ARB. However, these medicines are not always completely effective~     in stopping/reversing the kidney disease. Some studies have previously suggested that~     another type of medicine, called sitagliptin, normal used to treat diabetes may also help~     prevent diabetic kidney disease from getting worse.~      This study is being performed to test the effectiveness of sitagliptin as compared to a~     placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it~     will reduce protein levels in their urine. Protein levels in the urine are a marker of the~     severity of kidney disease.~   "
77045|NCT02048891|"~     Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely,~     human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the~     natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a~     natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH).~     To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing~     hormone (GnRH) agonist can be given.~      The purpose of this study is to find out which approach may work better in IVF patients who~     experienced 4 IVF failures.~   "
77046|NCT02048878|"~     The purpose of this study is to determine whether individuals with chronic insomnia disorder~     have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good~     sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic~     hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients~     with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass~     index (BMI) and race/ethnicity.~   "
77047|NCT02048865|"~     Cancer patients have an increased risk of developing blood clots in the veins compared to~     non-cancer patients. Cancer patients who develop blood clots can lead to reduced life~     expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most~     effective way to decrease the complications associated with blood clots in the veins.~     Although previous clinical trials have shown some benefit on the use of medication to~     prevent blood clots in the veins in ambulatory cancer patients, these studies have been~     inconclusive in demonstrating that existing blood thinners significantly reduce the rate of~     blood clots in cancer patients. One possible explanation relates to the fact that these~     studies have included a large proportion of cancer patients who are a low risk of developing~     blood clots in the veins. We are proposing to identify cancer patients who are at a high~     risk of developing blood clots by using a validated tool at the time of their cancer~     diagnosis. The identified high risk cancer patients will be asked to participate in a trial~     to test the safety and efficacy of a new oral medication that has been used to prevent blood~     clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers~     (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients~     will receive the study drug and 287 will receive an inactive substance. Analysis will be~     performed to assess the safety and the superiority of the study drug.~   "
77048|NCT02048852|"~     This study examines the potential effect of reducing nicotine content or menthol or both in~     women of reproductive age, a vulnerable population identified by the FDA in need of further~     research.~   "
77049|NCT02048839|"~     SUBJECTS:~      All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to~     this follow-up study, with their children (age 3-5 years) and the father. The investigations~     are carried out during two separate visits. The father receives mail questionnaires~      OVERALL OBJECTIVES:~        1. To determine the long-term effectiveness of a lifestyle intervention in high risk women~          and their offspring~             1. in reducing the incidence of T2DM and cardiovascular disease and their risk~               factors~             2. in preventing obesity~             3. on biomarkers~             4. on genetic and epigenetics markers .~        2. To study the association between maternal diet during pregnancy and metabolic markers~          in the offspring at age 3-5 years.~        3. To study the association between maternal exercise habits during pregnancy and~          metabolic markers in the offspring at age 3-5 years.~        4. To study the association between maternal a) glucose-insulin metabolism b) lipid~          metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later~          health outcomes in the mothers and their offspring.~        5. To study the association between gut microbiota and markers of offspring health~        6. To study the cost effectiveness of the intervention.~      METHODS:~      Maternal measurements~        1. Height, weight, waist and hip circumference~        2. Blood pressure, pulse~        3. Body fat percentage~        4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone~          markers, DNA sample and inflammation markers~        5. Fecal and hair samples~        6. Diurnal salivary cortisol assessment~        7. Background questionnaire: socioeconomic and health-related background~        8. Health-related quality of life (15-D).~        9. 3-day food diary and exercise diary~       10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days~       11. Psychological questionnaires~       12. Pulse wave velocity (PWV) will be assessed~       13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed~      Paternal measurements~        1. Background questionnaire (incl. height, weight, age)~        2. DNA-sample (buccal)~        3. 3-day food diary~        4. Psychological questionnaires~      Measurements of children~        1. Body weight, height, blood pressure, pulse~        2. Body fat percentage~        3. Psychological questionnaires~        4. Food and physical activities diaries~        5. ActiGraph, assessment of physical activity and sleep for 7 days~        6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and Calcium,~          DNA-sample and samples for inflammation markers~        7. Fecal, urine and hair samples~        8. A copy of child welfare center card (e.g. data on growth, immunizations, health)~        9. Endothelial function and pulse wave velocity (PWV)~      TIMETABLE~      Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2016~     and results will be reported from 2016 onwards in international peer-reviewed journals.~   "
77050|NCT02048826|"~     The purpose of this study is to determine the effectiveness of training hand movement using~     FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users~     to play computer games using those movements.~   "
77051|NCT02048813|"~     This randomized phase III trial studies ibrutinib and rituximab to see how well they work~     compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with~     untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab,~     interfere with the ability of cancer cells to grow and spread. It is not yet known whether~     fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and~     rituximab in treating patients with untreated chronic lymphocytic leukemia or small~     lymphocytic lymphoma.~   "
77126|NCT02047825|"~     Multiple sclerosis is a chronic and highly disabling disorder with considerable social~     impact and economic consequences. It is caused by damage to the myelin sheath, the~     protective covering that surrounds nerve cells. Different areas are affected, including~     manual dexterity, strength, coordination and function. The objective of this study is to~     evaluate the improvement in these variables in patients with multiple sclerosis after a~     8-weeks intervention focused on upper limbs.~   "
77052|NCT02048800|"~     Every year around 70 children affected by cancer or life-threatening genetic diseases~     undergo haematopoietic cell transplantation (HCT) within the Blood and Marrow Transplant~     (BMT) unit at Great Ormond Street Hospital (GOSH).~      One of the main goals of the BMT unit over the last decade has been to reduce the morbidity~     and mortality related to HCT, and the group has become a world-leader in pioneering less~     toxic transplants.~      Fixed high doses of chemotherapy drugs are generally used to prepare children for HCT but~     several studies have shown a correlation between the concentration of these drugs achieved~     in the patient's blood, and the success or failure of the HCT procedure.~      Recently a new drug, Treosulfan, has become available for use in patients undergoing HCT,~     and GOSH has pioneered its introduction in children undergoing HCT. With promising early~     results, Treosulfan has become the pre-HCT drug of choice, however, very little is currently~     known about how the drug is metabolised and cleared from the body, particularly in children.~      The investigators therefore plan to investigate the pharmacokinetic (PK) profile of~     Treosulfan in children undergoing HCT at GOSH and define which parameters affect its~     metabolism and clearance, and what blood levels are associated with a favourable outcome~     (graft take without toxicity) or a poor result (graft rejection and/or toxicity).~   "
77053|NCT02048787|"~     To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral~     dose in subjects with moderate and severe renal impairment.~   "
77054|NCT02048774|"~     Obesity is often cited as being inversely related with socioeconomic status (SES), although~     the mechanisms linking social status with obesity are not well understood. Dietary~     restraint, physical activity, and social mobility have been proposed as possible mechanisms.~     Although there is some evidence of SES variation in the proposed mechanisms, evidence is~     mixed and mostly observational. The purpose of this research is to determine if one's social~     position influences eating behaviors. This study will attempt to determine this using a~     randomized, 2 parallel arm trial to determine the effects that social hierarchy positioning~     has on energy intake. To prevent compromise in the integrity of data, the investigators will~     detail the exact treatment condition (i.e., social positioning) after the data collection~     period.~      Based on findings from previous animal and large clinical observational studies, there are~     two complementary hypotheses tested in this study. First, it is hypothesized that being in a~     lower social position affects one's perception of food availability by making the future~     availability of food seem less certain. This uncertainty will lead to increased food~     consumption. Second, it is hypothesized that being in a position of power will lower one's~     food consumption, as previous research has found that individuals in power tend to east less~     in groups. Understanding how social position influences food intake could help improve~     weight loss/maintenance interventions by identifying unexpected factors that could limit the~     intervention's effectiveness.~   "
77055|NCT02048761|"~     This study was designed as a randomized, controlled clinical trial to evaluate the efficacy~     of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects~     in chronic periodontitis in comparison with placebo gel.~   "
77056|NCT02048748|"~     Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may~     provide benefits on health care costs and quality of life. Currently there is limited use of~     remote monitoring for heart failure in Norway. The funding streams and the structure of the~     norwegian health service is different from other countries that have tried remote monitoring~     and therefore it is important to examine the utility of such services in Norway. The study~     is a randomised controlled trial that will allow participants in the intervention group to~     use a wireless weight scale and blood pressure monitor device that will send automatically~     the measurements electronically and securely to the Heart Failure Outpatient Clinic of the~     hospital.~   "
77057|NCT02048722|"~     The purpose of this study is to see whether a drug called regorafenib might be effective in~     treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten~     worse after they received chemotherapy. Regorafenib is a type of drug called a kinase~     inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases~     in cancer cells might normally help the cancer cells grow or form new blood vessels that~     could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth~     of certain cancers.~   "
77058|NCT02048709|"~     This is an open-label Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to~     inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system~     attack solid tumor cells more effectively.~   "
77059|NCT02048696|"~     Patients who have suffered a heart attack are at risk of developing worsening heart function~     and heart failure. Exercise training has a beneficial effect on heart function and prevents~     heart failure. The aim of the current study is to investigate the effect of exercise~     training on heart function in patients who have suffered a heart attack.~   "
77060|NCT02048683|"~     Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with~     control ICU patients.~   "
77061|NCT02048670|"~     This pilot study is focused on what assistance an external prosthetic device, the~     BalanceBeltTM can provide in the: 1) assessment and 2) treatment for patients with Chronic~     Subjective Dizziness (CSD). The BalanceBelt has sensitive detectors for movement in the~     anterior/posterior and medial/lateral planes and provides the person wearing the device~     vibro-tactile feedback as to the persons orientation with respect to gravity. The device is~     a full self contained device that is comfortably worn around the waist over a light weight~     shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients~     with CSD do not have permanent vestibular deficits, but underutilize vestibular signals~     because they develop visual or somatosensory dependence. The investigators expect the~     BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.~   "
77062|NCT02048657|"~     Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are~     developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion~     guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the~     standard introducer-tool (I-Tool).~   "
77509|NCT02042846|"~     The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying~     ultrasonic energy. This provides an intimate bond between implant and bone delivering~     immediate stability.~      The purpose of this study is to evaluate the surgical and clinical outcome of the~     SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.~   "
77063|NCT02048644|"~     The investigator has recently studied markers of platelet activation in idiopathic pulmonary~     fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet~     reactivity when compared with controls which is demonstrated by a concentration dependent~     increase in platelet-monocyte complex formation, platelet P-selectin expression and platelet~     fibrinogen binding in the presence of` the platelet agonists Adenosine diphosphate and L-~     Threonyl- L- phenylalanyl- L- leucyl- L- leucyl- L-argininamide (TFLLR).~      During platelet activation the platelets degranulate releasing numerous profibrotic~     cytokines including Transforming growth factor beta and Platelet derived growth factor that~     are recognised to be important in the pathogenesis of IPF. It is therefore plausible that~     the observed increased platelet reactivity in IPF contributes to the fibrotic process~     through local activation and degranulation with release of proinflammatory and profibrotic~     mediators within the pulmonary circulation.~      There is evidence that corticosteroid treatment may alter platelet adhesion, in a study of~     spontaneously hypertensive rat (SHR) increased circulating glucocorticoid, suppressed~     p-selectin expression. p selectin is a transmembrane protein present in the α granules of~     platelets. P selectin has a crucial role in platelet aggregation and platelet-leukocyte~     interactions, which are both potentially important mechanisms in the initiation and/or~     progression of tissue injury and development of thrombosis. In a study of patients with~     chronic obstructive pulmonary disease (COPD) exacerbation these were treated with either β~     agonists alone or β agonist and 40mg prednisolone and compared with a control group. At~     presentation the COPD patients had higher pulmonary artery pressure (PAP) higher p selectin~     and fibrinogen levels but lower Antithrombin III levels (AT III). The pulmonary artery~     pressure and fibrinogen levels were found to be significantly decreased in the steroid~     treated group whilst the p-selectin levels further increased in the non steroidal therapy~     patients.~      Rationale for the Current Study~      There is a significant unmet medical need for the treatment of IPF; the only medication~     approved for treatment of IPF in the United Kingdom (UK) is Pirfenidone and outside the UK~     there is none. The main goal of the current study is to evaluate the effect of Fostair on~     the biomarkers of platelet activation in IPF disease which the investigator believes play a~     pivotal role in the pathogenesis of IPF and whether this translates in to a clinically~     beneficial effect of Fostair on IPF disease.~   "
77064|NCT02048631|"~     The aim of the study is to investigate post-surgery sensory impairment and life quality~     changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6~     months, 12 months, and 24 months, respectively~   "
77065|NCT02048618|"~     -  180 patients suffering from active Crohn's disease with evidence of mucosal ulceration~          will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634~          or matching placebo once daily for 20 weeks in addition to their stable background~          treatment.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur (safety and tolerability), and the amount of GLPG0634 present in the~          blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism~          of action-related parameters in the blood and stool (Pharmacodynamics) will be~          determined. Also, the effects GLPG0634 administration on subjects' quality of life will~          be evaluated.~   "
77066|NCT02048605|"~     Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral~     group-training-program to reduce stress and augment quality of life. An unspecific group~     with the same amount and frequency of meetings is used as a control group. For the~     evaluation of the training effects, scales to assess quality of life, analyses of~     psychopathological variations as well as neurocognitive tests will be used. Protocol~     amendment in 1-2017: addition of FU year 3 and year 5.~   "
77067|NCT02048592|"~     The primary objectives:~      To evaluate the effect of immunonutrition on the adult patient suffering from cystic~     fibrosis~        1. Safety of immunonutrition~        2. The effect of immunonutrition on parameters of oxidative stress~        3. The effect of immunonutrition on the inflammatory parameters~        4. The effect of immunonutrition on nutrition status~      Hypothesis~      The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has~     been shown to positively modulate oxidative stress in the different clinical setting however~     it has not yet been evaluated inpatients with cystic fibrosis who frequently need some~     support by means of enteral nutrition. We anticipate that the substitution of routine~     enteral nutrition by immunonutrition will result in improving of oxidative stress~     parameters.~   "
77068|NCT02048579|"~     Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated,~     parent-teen-teacher collaborative intervention for middle school students with ADHD and~     academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen~     because of its potential ability to promote treatment maintenance and generalizability~     across school years, because parents will be taught to implement, monitor, and adjust~     intervention components as needed. Key innovative components in the STAND intervention~     address previously reported treatment barriers: 1) a parent-delivered academic intervention~     to promote maintenance and generalization across school years, and to relieve some of the~     burden of intervention delivery from teachers, 2) motivational interviewing to address~     parent disengagement from and adolescent resistance to the treatment process, 3) multiple~     tailored options for home-school communication, including a web-based support system, to~     facilitate home-school communication, and 4) empowering parents by coaching them to~     effectively and tactfully involve teachers in the treatment planning and monitoring process~     in order to increase teachers' willingness to support the child's academic needs. To study~     the feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42~     middle school students with ADHD will be recruited (total N=84) and randomly assigned to~     participate in STAND or a treatment-as-usual monitoring group. All participants will~     complete intake, mid-treatment, post-treatment, [and follow-up] assessments designed to~     monitor academic functioning, [intervention feasibility, compliance, and satisfaction].~      Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year~     generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens'~     Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of~     middle school students with ADHD. Intervention effects on ADHD symptomatology and~     impairment, grade-point-average (GPA), [organization, daily planner use], homework~     completion, teacher ratings of academic functioning and classroom behavior, and the~     parent-teen relationship will be examined.~      Aim 2: The proposed study will examine the acceptability and feasibility of the STAND~     program. Parents and teens will report on [satisfaction, barriers to treatment~     participation, therapeutic alliance, and treatment credibility] throughout the intervention~     and follow-up period. [Therapists will also complete ratings of parent and adolescent~     engagement and compliance with treatment procedures] will be collected from participants in~     the program. Parent, teen, and teacher compliance with intervention procedures will also be~     measured in order to assess feasibility. Treatment fidelity measures will also be collected~     in order to measure clinician adherence to the manualized STAND procedures.~      Aim 3: The proposed study will also explore ways to improve home-school communication during~     the middle school years. To this end, families will be given options regarding the modality~     of communication with teachers, and parent, teen, and teacher preferences for medium of~     intervention delivery will be examined (i.e., web-based, email, paper/pencil).~   "
77069|NCT02048566|"~     Hemodynamic management of critically ill patients is a constant challenge in the intensive~     care unit (ICU). Commonly used monitoring parameters to guide hemodynamic management~     generally consist of measurements of pressures (systemic and pulmonary artery pressures,~     cardiac filling pressures) and flow (cardiac output measurements using a thermodilution~     method). However, cardiac filling pressures and flow data have known limitations and might~     not accurately represent cardiac preload and contractility. Hemodynamic management of~     critically ill patients based on these parameters might therefore not be optimal and delay~     stabilisation of the patient, leading to negative outcomes and increased use of resources.~      Visualization of the heart using echocardiography offers the advantage of direct measurement~     of cardiac volumes and systolic function. Echocardiography has been established as a tool to~     evaluate the causes of hemodynamic instability in ICU patients by the visualization of~     cardiac chambers, valves and pericardium and cardiac functional abnormalities. A repeated~     echocardiographic assessment could potentially provide useful additional information~     resulting in more rapid resolution of hemodynamic instability. Using conventional TTE and~     TEE, however, limits the feasibility of such an approach due to a lack of time and~     availability of appropriately trained staff.~      In recently published studies the feasibility of hemodynamic monitoring and safety of hTEE~     was demonstrated. In the context of a prospective quality review assessment, the~     investigators showed that the echocardiographic examinations using hTEE were of sufficient~     quality in a majority of examined ICU patients and that the inter-rater reliability between~     the intensivists and a trained cardiologist was substantial. However, as of yet studies~     assessing the impact of hemodynamic monitoring by hTEE on relevant patient outcomes are not~     available. Given the associated costs for the hTEE device and the ultrasound probes and the~     additional resource requirements for training and application, the efficacy and efficiency~     of hTEE monitoring in comparison to standard monitoring should be established.~   "
77070|NCT02048553|"~     Background: Despite the widespread use of external ventricular drainage, revision rates and~     associated complications are reported between 10-40%. Current available image-guided~     techniques using stereotaxis, endoscopy or ultrasound for catheter placements remain~     time-consuming techniques. Recently, a phone-assisted guide with high precision has been~     described. The development of an easy-to-use, portable, image-guided system could reduce the~     need for multiple passes and improve the rate of accurate catheter placement. This study aim~     to compare prospectively in a randomized controlled manner the accuracy of the freehand pass~     technique versus an an easy-to-use, portable mini-tablet-assisted guide for ventriculostomy~     catheter placement.~      Methods/Design: This is a single center, prospective, randomized, trial with blinded~     endpoint (ventricle catheter tip location) assessment. Adult patients with the indication~     for ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the~     treatment group or the control group. In patients of the treatment group, ventriculostomy~     will be performed using a mini-tablet-guided assistance based on preoperative CT imaging.~     Patients in the control group will receive standard free-hand ventriculostomy using~     anatomical landmarks. The catheter may be placed for external drainage or internal~     (ventriculoperitoneal) shunting in both groups. The primary outcome measure is rate of~     correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading~     system for catheter tip location on postoperative CT scan. Primary outcome will be~     determined by one of the authors (NS) blinded for treatment allocation. We aim to include~     320 patients in 3 years.~      Secondary Outcome Measures include 1) Frequency of placements required, 2) Frequency of~     completed placements within the ventricle of the perforated part of the tip of the catheter,~     3) Frequency of very early and early shunt failures (revision of the ventricular drainage~     within 24 hours / within three weeks, 4) Frequency and Percentage of complications~     (procedure-related and nonsurgical) within three weeks, 5) Length of the trajectories from~     the dura level to the foramen of Monroe, the angle in the coronal plane towards midline (a)~     and towards the target (b) at the respective entry point, 6) ventricle size (the frontal~     occipital horn ratio (FOHR) and the width of the lateral ventricle in the coronal plane~     between the medial wall of the corpus callosum and the septum), 7) Differences (angles,~     distance of catheter tip from target) on the tablet-guided planned and postoperative~     trajectory on control computer tomography within 48 hrs (CT).~      Discussion: Here, we present the study design of a single center prospective randomized~     controlled trial to investigate whether tablet-guided application ventriculostomy is~     superior to the standard free hand technique. The strengths of this study are: 1. the~     prospective, randomized interventional character testing a new easy-to handle guided versus~     free-hand ventricular catheter placement, and 2. the power calculation is based on catheter~     accuracy using an available grading system for catheter tip location and calculated with use~     of recent study results of our own population, supported by data from prominent studies.~   "
88694|NCT01896336|"~     The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem~     presentation 5 mg in the induction of sleep in patients with primary insomnia.~   "
77071|NCT02048540|"~     Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by~     R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not~     enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with~     chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as~     an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators~     plan to evaluate the efficacy and safety of neoadjuvant Bev plus~     docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to~     investigate whether CTC is an effectiveness indicator.~      Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1)~     to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin,~     85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200~     mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles~     postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was~     detected every 8 weeks. All patients signed the informed consent.~   "
77072|NCT02048527|"~     Sequential culture media were introduced in order to meet the changing requirements of the~     developing embryo in vitro. However, there has been renewed interest in the use of~     single-step media, which allow the embryo itself to choose the necessary nutrients while~     maintaining a more stable culture environment. Previous studies suggest that sequential~     media do not appear superior to single-step media.~   "
77073|NCT02048514|"~     The purpose of this clinical study is to evaluate the safety and device performance of the~     Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal~     abdominal aortic aneurysms.~   "
77074|NCT02048501|"~     The purpose of this study is to gain a better understanding of the mechanism of weight~     regain through gut hormone (substances in the gut that control various functions of the~     digestive organs) and energy expenditure (the amount of energy a person uses to complete~     bodily activities).~      Our hypothesis is that gut hormone response might be different among subjects who are able~     to maintain weight loss and subjects with weight regain.~      For this study, investigators will measure fasting and postprandial (happening after a meal)~     gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in~     obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB).~     Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended~     daily) and body composition (the proportion of fat, muscle, and bone of an individual's~     body). The subjects body composition will be analyzed, including fat mass and fat free mass,~     by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information~     regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and~     energy expenditure and body compositions.~   "
77075|NCT02048488|"~     TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer,~     including:~        1. Anaplastic lymphoma kinase (ALK)~        2. The tropomyosin-related kinases TRKA, TRKB, and TRKC~      This is a sequential, open-label, non-randomized study with dose escalation in Phase 1,~     followed by expansion at a recommended phase 2 dose.~   "
77076|NCT02048475|"~     To study the behavior of EEG during changing desflurane concentrations.~   "
77077|NCT02048462|"~     Many studies have shown that vigorous exercise increases the risk of developing vascular~     thrombotic events and can result in sudden death during or immediately after exercise. The~     outcome of these studies is biased by several confounding variables: subjects, type of~     exercise, duration, intensity and especially the method used for the evaluation of the~     hemostatic capacity. The goal of our study is to investigate the effect of strenuous~     exercise with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool~     in detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it~     also feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to~     physiology since all the blood cells are present, but also to avoid the centrifugation step.~     With our study we would like to see whether the other blood cells also play a role in the~     increase in TG. The objective is to investigate the effect of strenuous exercise~     (participation to the Amstel Gold Race) on coagulation and haemostatic parameters. We~     hypothesize that strenuous exercise induces a prothrombotic phenotype and that especially~     the tests involving blood cells will be altered into a prothrombotic phenotype.~   "
77078|NCT02048449|"~     Title:~      Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings~     in the diagnosis of laryngopharyngeal reflux disease~      Participants:~      Voluntary participants after invitation among members (a total of about 40~     gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and~     an otorhinolaryngologist~      Primary endpoint:~      Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7~     points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off~     value for the diagnosis of laryngopharyngeal reflux disease)~      Secondary endpoint:~      Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among~     gastroenterologists~   "
77079|NCT02048436|"~     The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system~     Respiration Rate technology.~   "
77080|NCT02048423|"~     1. Investigate the safety and effectiveness of a single dose of IV Ketamine for~          adolescents with suicidal ideation and depression. It is hypothesize that Ketamine will~          be well tolerated and significantly reduce depressive symptoms and suicidal ideation.~        2. Explore whether decision making as measured by the Iowa Gambling Task changes before~          and after Ketamine infusion. It is hypothesize that IV Ketamine infusion will~          significantly improve the decision making ability a measured by the Iowa Gambling Task~          in adolescents that are suicidal.~   "
77081|NCT02048410|"~     Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to~     evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a~     combination of probiotic and prebiotics and amine in the treatment of children affected by~     familial hypercholesterolemia (FH).~   "
77148|NCT02047539|"~     The primary objective of this study is to determine whether aspirin is effective in~     alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The~     investigators further aim to determine whether it may delay or prevent the onset of~     psychosis in those currently experiencing CHR symptoms. As secondary measures the~     investigators aim to collect laboratory studies of inflammation markers and genetic samples~     to determine whether certain genetic profiles correlate with risk for psychosis, or response~     to aspirin treatment.~   "
77082|NCT02048397|"~     The effect of Pulmonary Rehabilitation in patients with bronchiectasis (BC) is not~     sufficiently studied. The aim of this study is to assess the clinical and biological~     response of a Pulmonary Rehabilitation Program (PRP) for 12 weeks in BC vs PRP plus~     hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate~     (HMB).~      Methods: single center randomized controlled trial, parallel treatment design: Participants~     will be randomized assigned either will receive (n=14) PRP for 60 minutes, two supervised~     sessions per week in the hospital and one unsupervised session at home vs PRP (n=14) plus~     ONS (one can per day).~      Outcome assessments will be performed at baseline, 12 weeks and 24 weeks:~      1.- effort capacity &#8211;cardiopulmonary exercise test-, 2.- body composition~     (anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance, phase~     angle), 3.- peripheral muscle strength (dynamometry and respiratory -PEM (maximum expiratory~     pressure)and PIM (minimum expiratory pressure)-), 4.- spirometry, 5.- respiratory symptoms~     (bronchorrhea, dyspnoea, exacerbations),6.- level of physical activity (IPAQ questionnaire~     plus objective physical activity (WGT3X)), 7.- quality of life (QOL-B-Spain) ,~     8.-psychological symptoms (HASD) and 9.- biological markers of inflammation (leptin,~     adiponectin, interleukin-6, tumor necrosis factor-alpha, ultrasensitive C-reactive protein,~     GPR55 (G protein-coupled receptor 55) RNAm (messenger ribonucleic acid) expression in white~     blood cells) and oxidation (total antioxidant capacity, superoxide dismutase activity,~     8-iso-prostaglandin F2a, Thiobarbituric acid reactive substances).~   "
77083|NCT02048384|"~     This is a phase 1b, multi-center, open label, randomized study to evaluate the safety and~     feasibility of administering metformin with or without rapamycin after disease stabilization~     on chemotherapy in subjects with metastatic PDA.~   "
77084|NCT02048371|"~     Although regorafenib was approved for use in patients who had progressive GIST despite~     imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been~     examined in a systematic fashion in patients with other forms of sarcoma.~      Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and~     evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like~     sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such~     as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small~     molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib~     have overlapping panels of kinases that are inhibited simultaneously. While not equivalent,~     most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial~     growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to~     a common mechanism of action of several of these agents.~   "
77085|NCT02048358|"~     In this first in human study the aim is to assess the safety, pharmacokinetics and~     pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and~     active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1).~     Furthermore, the findings obtained from part 1 will be extended and confirmed in a~     subsequent parallel open label study in 18 healthy male and 12 MS patients and an open label~     study with methylprednisolone as comparator in 12 female volunteers (part 2).~   "
77086|NCT02048345|"~     The aim of this study is to understand the behavior of posaconazol gives as a suspension and~     solution in the gastrointestinal tract in human volunteers. The investigators know that~     supersaturation for this compound can be achieved by the influence of the gastrointestinal~     tract: The acid environment of the stomach creates a optimized environment for the basic~     compound to reach a high solubility, while the neutral environment of the small intestine~     creates a low solubility environment for the compound. The transit from stomach to small~     intestine gives the opportunity for the drug to create a supersaturated solution. Giving the~     drug as a solution to the healthy volunteer makes sure that precipitation is not occurring~     in the stomach and that precipitation has to happen in the small intestine. After all,~     supersaturation is a state that is not thermodynamic stable and always will want to~     precipitate. Giving the drug as a suspension to the healthy volunteers, can make it possible~     that still some particles of the drug are not in dissolution and that those particles will~     flow to the small intestine where other particles easily can bind to. This will make that~     almost the whole supersaturated solution is immediately precipitated.~      The investigators want to give the suspension by the authorized drug called Noxafil. On the~     other hand an aqueous solution will be made by adjusting the pH to 1.2 (which is conform~     with the pH of the stomach) and given to the volunteers by the stomach catheter. This 2~     formulations will be tested in a fasted state and a fed state (by giving 2 Ensure plus~     shakes to the volunteers before the experiment starts). After intake of the formulation,~     gastric and duodenal fluids will be aspirated by the catheters and analyzed at their~     laboratory. So the four conditions the investigators want to study are:~        1. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water~          in a fasted state~        2. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil)~          in 247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a~          fasted state.~        3. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water~          in a fed state (by giving 20 minute before intake of the formulation, 2 ensure plus~          shakes)~        4. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil)~          in 247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a~          fed state (by giving 20 minute before intake of the formulation, 2 ensure plus shakes).~      By getting more knowledge about the behavior of posaconazol (interplay supersaturation /~     precipitation) more insights can be achieved for the development of supersaturating drug~     delivery systems.~   "
77087|NCT02048332|"~     In this research study, we want to learn more about the use of donor-derived cytotoxic~     T-cells (CTLs) to treat viral infections that occur after allogeneic stem cell transplant. A~     cytotoxic T cell is a T lymphocyte (a type of white blood cell) that kills cells that are~     infected (particularly with viruses). Allogeneic means the stem cells come from another~     person. These CTLs are cells specially designed to fight the virus infections that can~     happen after a bone marrow transplant.~      We are asking people who have undergone or will undergo an allogeneic stem cell transplant~     to enroll in this research study, because viral infections are a common problem after~     allogeneic stem cell transplant and can cause significant complications including death.~      Stem cell transplant reduces a person's ability to fight infections. There is an increased~     risk of getting new viral infections or reactivation of viral infections that the patient~     has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV) and adenovirus~     (ADV). There are anti-viral medicines available to treat CMV, EBV and ADV infections, though~     not all patients will respond to the standard treatments. Moreover, treatment of viral~     infections is expensive and time consuming, with families often administering prolonged~     treatments with intravenous anti-viral medications, or patients requiring prolonged~     admissions to the hospital. The medicines can also have side effects like damage to the~     kidneys or reduction in the blood counts, so in this study we are trying to find an easier~     way to treat these infections.~   "
77106|NCT02048085|"~     This study involves doing platelet function testing in patients who have undergone~     fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of~     care to restore blood flow in blocked arteries as soon as possible after the Heart attack~     in rural health center where access to cardiac catheterization is one hour away.~     Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the~     damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient~     undergoing fibrinolysis has been well studied in many trials. In this study investigators~     will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect~     by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs~     (Pharmacokinetics).~   "
77088|NCT02048319|"~     Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the~     general population, typically not causing any symptoms or complications. However, in a small~     subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea~     occur.~      Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients~     with a large dominant liver cyst. However, studies reported early fluid reaccumulation and~     relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately~     leading to re-interventions. In this respect, somatostatin analogues are promising agents~     known for its volume reducing effect in patients with polycystic liver disease.~      In this study the investigators want to evaluate the effect of combining aspiration~     sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue~     Pasireotide.~      The investigators hypothesize that administrating pasireotide before and after aspiration~     sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater~     reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst~     recurrence and subsequently lower need for re-interventions.~   "
77089|NCT02048306|"~     The purpose of this study is to explore the impact of Family-based pulmonary rehabilitation~     (PR) on patients with chronic obstructive pulmonary disease (COPD) and their family members.~      Dyads (patient and respective family member) will be randomly allocated to either a~     Family-based PR group or a Conventional PR group. PR programs will consist of exercise~     training and psychoeducation. In the Family-based PR program, both patients and family~     members will participate in psychoeducation sessions. In the Conventional PR group, only~     patients will be included. In both groups, exercise training sessions will be exclusively~     for patients.~      It is expected that, by including patients with COPD and their family members in~     Family-based PR, they will become more competent and confident in the management of the~     disease, thus reducing the overall impact of COPD on patients and family members'~     well-being.~   "
77090|NCT02048293|"~     Unbranded drug molecules are produced after the patent of a given drug has expired.~     Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by~     anesthesiologist indicate that there are differences in the physiologic response of patients~     to these molecules. The investigators hypothesized that unbranded molecules of remifentanil~     require higher doses to obtain desired physiological responses as compared to the branded~     molecule.~   "
77091|NCT02048280|"~     Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses~     the diaphragm's normal electrical activity to deliver a mechanically supported breath. The~     amount of support provided is determined in part by the NAVA level, where a higher NAVA~     level will provide higher level of support and unload more of the work of the diaphragm. The~     purpose of this study is to compare the optimal NAVA level in neonates while on mechanical~     ventilation while intubated and after being extubated.~   "
77092|NCT02048267|"~     Numerous treatment modalities have been proposed to treat pain in alcoholic and~     non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid~     production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of~     oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have~     shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in~     non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and~     differences on the basis of outcome in between alcoholic and non-alcoholic chronic~     pancreatitis are not available in literature.~      Although it is well known that pain is the main symptom of chronic pancreatitis, it has~     until now been assessed in very common and varying categories. Pain, however, is only one~     aspect of the large variety of sensitive facets of daily life. In addition to an improvement~     in pain symptoms and the preservation of pancreatic exocrine and endocrine function and~     other parameters, occupational rehabilitation of these mostly young patients and quality of~     life also should be considered in the evaluation of surgical outcome in alcoholic and~     non-alcoholic chronic pancreatitis.~      In this prospective study, we intend to find out if there are any differences in the~     surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic~     pancreatitis.We also plan to see if there are differences in the histopathology in these two~     disease settings.~   "
77093|NCT02048254|"~     -  To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to~          treat inoperable salivary gland carcinoma.~        -  To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat~          inoperable salivary gland carcinoma.~   "
77094|NCT02048241|"~     Children with explosive aggression are often rejected by their peers, placed in special~     classroom, and contribute to family discord. When psychotherapy and family therapy is~     unsuccessful, medications are often used. Current medications are stimulants (e.g.~     methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics~     (olanzapine, risperidone). At this time, the available medications are of limited~     usefulness, either because they do not always work or because they have side effects such as~     weight gain or insomnia. There is a clear need for new medications to treat explosive~     aggression when psychotherapy is unsuccessful.~      The hypothesis of this study is the medication Intuniv when combined with psychotherapy will~     be more helpful to children with explosive aggression than placebo combined with~     psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA~     for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor~     is it an anticonvulsant, nor is it an antipsychotic.~      The children in this study will be between the ages of 6 and 12 and meet Diagnostic and~     Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for~     Intermittent Explosive Disorder.~   "
77095|NCT02048228|"~     Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering~     from Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel~     varies substantially among individuals. Several loss‐of‐function polymorphisms have been~     identified that may influence clinical outcome in patients presenting with acute coronary~     syndromes (ACS) who are treated with clopidogrel. However their contribution to high~     on-treatment platelet reactivity (HPR) in clopidogrel treated Chinese patients is less~     known. As far as we know, ticagrelor is not dependent on gene-based metabolic activation and~     demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention~     trial. we will conduct an interventional study to compare the antiplatelet efficiency~     between clopidogrel and ticagrelor by the guidance of CYP450 2C19*2 (CYP2C19*2) , using~     Taqman genotyping method.~   "
77096|NCT02048215|"~     Brief Summary This trial was part of a sub-project targeted to diet, thermogenesis and~     obesity of a larger multicentre study named Interaction between nutritional,~     social-behavioral and metabolic factors for prevention of cardiovascular disease:~     development of nutritional strategies on general population.~      Ephedrine and caffeine (EC) combination has been widely used in human obesity treatment. It~     is known that this drug increases the metabolic rate in both animals and humans. Ephedrine~     is an agonist of both α and β-adrenoceptors; moreover, it induces norepinephrine release~     from sympathetic neurons. Caffeine increases both norepinephrine and dopamine release and~     stimulates the neuronal activity in several brain regions. We hypothesize that EC treatment~     might exert a specific effect on lipolysis and thermogenesis by stimulation of beta-3~     adrenoreceptors on adipose tissue and by stimulating uncoupling of oxidative~     phosphorylation, i.e. energy being dissipated as heat rather than being converted to~     adenosine triphosphate (ATP)~      Our study is a double-blind, placebo-controlled, 4-week trial to investigate the effect of~     hypocaloric diet alone or coupled to EC treatment of morbidly obese women on thermogenesis,~     expression of UCP 3 (in muscle tissue) and of beta-3 adrenoreceptors (in adipose tissue).~     Subjects are randomly assigned to EC (200/20 mg) or to placebo administered three times a~     day orally together with a energy-deficit diet (70% of resting energy expenditure), starting~     one month before undergoing bariatric surgery. Primary study endpoints are weight change~     analysed by intention to treat, changes in resting energy expenditure, UCP3 (long and short~     isoform), messenger ribonucleic acid (mRNA) levels in rectus abdominis and immunostaining~     for beta-3 adrenoreceptors in subcutaneous and omental adipose tissue. Also plasma~     epinephrine, norepinephrine, triglycerides, free fatty acids, glycerol, TSH, free thyroxine~     (fT4), free triiodothyronine (fT3) fasting glucose, insulin and homeostasis model assessment~     (HOMA) index, are measured at baseline and at the end of treatments.~   "
77097|NCT02048202|"~     The study will compare intervention by Infant Aquatics to infant massage. The intervention~     in both methods will start at 36 weeks gestational age for 3 months and will consist of~     sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8~     and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland~     adaptive behavior scales.~   "
77098|NCT02048189|"~     This is an open multicentre, randomized study to compare two treatment arms. One arm called~     intensification of multiple injections in which the patient will receive one supplementary~     injection of LEVEMIR®: that is to say 5 injections per day, and an arm called continuous~     insulin infusion via an external pump with APIDRA®.~      In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved~     metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia~     curve noted during the continuous glycemia recording; an improvement in quality of life~     compared with treatment using multiple injections.~   "
77099|NCT02048176|"~     Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior~     fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of~     mutism 1-6 days after surgery that can spontaneously improve on average from 7-8 weeks~     later. Few patients recover normal speech. Most of their speech continues to be marked by~     dysarthria, dysfluency and slowed rate. Researchers have not identified the pathophysiologic~     mechanism for PFM nor have they found a cure. Despite the improvements in speech, patients~     with PFM have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few~     studies have looked at long term outcomes of patients affected by PFM. We propose to survey~     patients who developed PFM after resection of a medulloblastoma to determine long term~     effects of PFM on patient's quality of life.~   "
77100|NCT02048163|"~     The purpose of this study is to compare the incidence of nausea and vomiting following short~     intermittent versus prolonged intermittent infusion of meropenem.~   "
77101|NCT02048150|"~     This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen~     (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in~     visualization of the prostate. Attaching a fluorescence, a substance that emits radiation~     that is visible, to the anti-PMSA antibody and injecting it into the body may help identify~     the tumor when specialized microscopes are used.~   "
77102|NCT02048137|"~     In the study we test whether transcranial direct current stimulation can reduce the~     perception of pain in patients with chronic inflammatory bowel diseases.~      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in~     patients with chronic inflammatory bowel diseases.~   "
77103|NCT02048124|"~     Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle~     Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological~     (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle,~     a new needle named ProCor was developed in the hope of obtaining core samples and thus~     increase diagnostic yield.~      Objective: In this research project, we propose to conduct a prospective trial to compare~     the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g~     ProCor needle (25gP).~      EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a~     randomisation sequence will set in order to determine which of the two needles will first be~     used (25S or 25P).~      The cytological or histological diagnoses will be made; . for histological diagnosis, the~     pathologist will first establish the presence or absence of a tissue core (defined as a~     measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen:~     cellularity (score 1 poor; score 2 good; score 3 excellent),[14] sample bloodiness~     (score 1 minimal;score 2 moderate; score 3 significant, and the presence or absence of~     malignancy(positive / negative / suspicious / inconclusive).~      Results for continuous variables will be summarized using mean ± SD, . and categorical~     variables using proportions. The 25S and 25P groups will be compared using Chi-square test~     for categorical variables and, Student t test for continuous variablesTwo-sided p values~     less than 0.05 will be considered statistically significant. Data will be analyzed using~     SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.~   "
77104|NCT02048111|"~     To evaluate the safety (acute adverse effects associated with infusions, and inhibitor~     development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and~     control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.~   "
77105|NCT02048098|"~     The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3~     hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable~     pregnancy~   "
77116|NCT02047955|"~     The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on~     designated commercially available Tornier Shoulder repair products. In addition, this study~     will provide performance data for use in education, marketing materials, peer-reviewed~     publications and support research and development of future products.~   "
88695|NCT01896323|"~     This is a single-center open-label study to compare how CC-223 (the study drug being~     investigated) interacts with the drug ketoconazole.~   "
77107|NCT02048072|"~     This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the~     autonomic nervous system in patients being treated for the first time with Gilenya~     (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is~     conducted to answer the question, if, and if yes, what impact the treatment with Gilenya~     (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the~     effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but~     potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya~     (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are~     of interest. Maybe a better understanding of these mechanisms might even be of clinical~     relevance (e.g. risk stratification).~      The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured,~     using a state-of-the-art technique. Non-invasive blood pressure measurement is performed~     with the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing~     at rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin~     reaction is performed. The non-invasive blood pressure measurements are done by continuous,~     plethysmographic blood pressure measurement at the index finger, while the patient is~     performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate~     and blood pressure variability are calculated. The sympathetic skin reaction consists of~     measuring the change of electric conductibility of the skin (palms and soles) after an~     electric stimulus of a peripheral nerve. These parameters allow to assess the functionality~     of four important autonomic functional systems (orthostasis, sympathetic adrenergic,~     sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in~     our lab.~      Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared~     to baseline (t0) for the parameter RMSSD under normal breathing.~   "
77108|NCT02048059|"~     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells~     in breast cancer patients with recurrent brain metastases.~   "
77109|NCT02048046|"~     Patients with heart and/or lung failure are some of the sickest patients in our hospital~     systems. In severe cases they often need long periods of specialist care in Intensive Care~     Units (ICU) in Australia and New Zealand. Extracorporeal Membrane Oxygenation (ECMO) is an~     extremely specialised and costly form of life support, only being utilised when a patient is~     close to death as a last resort to save their life. This form of life support has been used~     for many years in babies and children but is relatively new for adults. Whilst there is~     evidence emerging of the positive effects of ECMO in adults, there is a lot that is unknown~     and further research is required.~      Another essential therapy that assists patients in their recovery from illness is the~     provision of artificial nutrition. This liquid formula is delivered into the stomach or as a~     nutritionally rich fluid provided into the vein. Until recently nutrition was~     under-emphasised in the critically ill, however, it has now become clear that targeted~     nutrition can positively affect a person's outcome and is vital during long periods of~     intensive care hospitalisation.~      There is very limited data on how nutrition affects the outcomes of ECMO patients (positive~     or negative). We know from limited studies that these patients receive less nutrition than~     other patients, something that is particularly concerning given that less nutrition leads to~     a longer hospital stay and has been linked a with higher hospital mortality. We also think~     that adult patients on ECMO need more nutrition as they appear to lose more weight than~     patients with other illnesses in intensive care; however this has not been confirmed. It is~     thus essential that we understand the effects of this relatively simple but vital therapy on~     these very sick patients.~      This study proposes to collect information on the current feeding practices in patients on~     ECMO and describe the factors that inhibit or allow provision of nutrition so that we can~     understand the issues that exist, develop strategies to improve delivery of nutrition and~     determine areas for further research.~   "
77110|NCT02048033|"~     Prospective multicenters randomized study to compare the efficiency and the socioeconomic~     impact of the endoscopic management (Overstitch technique) of weight regain after gastric~     bypass surgery to non invasive treatment~   "
77111|NCT02048020|"~     This phase II trial studies how well paclitaxel and carboplatin before radiation therapy~     with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage~     III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x~     rays to kill tumor cells. Giving paclitaxel and carboplatin before radiation therapy with~     paclitaxel may kill more tumor cells.~   "
77112|NCT02048007|"~     The long-term goal of this study is to more precisely define the role of mass azithromycin~     treatments as an intervention for reducing childhood morbidity and increasing growth, and~     for the potential selection of antibiotic resistance. The investigators propose a set of 3~     cluster-randomized trials comparing communities randomized to oral azithromycin with those~     randomized to placebo. To assess the generalizability of the intervention, investigators~     will monitor for antibiotic resistance, which could potentially limit adoption of mass~     antibiotic treatments. The investigators will also assess several measures of infectious~     diseases. The investigators hypothesize that mass azithromycin treatments will reduce~     childhood morbidity and will be accompanied by an acceptable level of antibiotic resistance.~   "
77113|NCT02047994|"~     Currently no ideal preventive modalities are available for reducing gastric-cancer caused~     mortality in organized population-based application. The primary objective of the study is~     to determine if H.pylori screening followed by eradication of positive subjects and~     endoscopic follow-up of those with serological evidence of atrophic gastritis reduces~     mortality from gastric cancer in middle-aged people in high-risk areas. The GISTAR study is~     a multicenter randomized study of H.pylori eradication and pepsinogen testing for prevention~     of gastric cancer mortality. Altogether 30.000 individuals aged 40-64 years will be~     enrolled, providing 90% study power to detect at least 35% reduction in gastric cancer~     mortality at 15 years of follow-up; initially a pilot study with approximately 3000~     individuals is planned. Participants will be randomly allocated to one of two groups. In the~     active investigation/management group those positive for H.pylori will be offered~     eradication therapy and individuals with decreased pepsinogen I/II ratio will be invited for~     endoscopy. The control group will receive standard health care. The primary endpoint for~     this trial will be the mortality difference from gastric cancer between the two groups at 15~     years or when enough cases accumulate to demonstrate a statistical difference. The study is~     expected to provide valuable information on the utility for reduction in gastric cancer~     mortality of: 1) H.pylori eradication in adults on a population-basis, including subjects~     who may already have pre-malignant lesions; and 2) pepsinogen testing in screening settings.~   "
77114|NCT02047981|"~     Our long-term goal is to more precisely define the role of mass azithromycin treatments as~     an intervention for reducing childhood mortality. We propose a single multi-site~     (multi-country), cluster-randomized trial comparing communities randomized to oral~     azithromycin with those randomized to placebo. We hypothesize that mass azithromycin~     treatments will reduce childhood mortality.~   "
77115|NCT02047968|"~     The objective of the study is to examine whether a combination of wake therapy, light~     therapy and sleep time stabilization as a supplement to standard treatment can reduce~     depressive symptoms in patients admitted at two psychiatric wards at Aarhus University~     Hospital, Risskov. Seventy-four patients will be randomized either to this intervention or~     to a control group receiving treatment as usual. Furthermore, it will be examined whether~     the duration of admission can be reduced in the intervention group. Finally, the aim is to~     identify predictors of good effect of the intervention.~   "
77117|NCT02047942|"~     Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to~     long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction~     in subjects with cardiovascular disease. However, the majority of cardiac patients do not~     engage in enough physical activity to obtain benefits or in the long-term struggle to~     maintain a physically active lifestyle. There is a need for innovative rehabilitation~     methods aiming at increasing longer-term adherence and hence more sustained effects on~     health related physical fitness. One strategy might be the use of home-based training in~     combination of telemonitoring guidance. Therefore, the main objective of this randomized~     controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month~     supervised center-based rehabilitation program with a patient-tailored home-based cardiac~     rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary~     outcome measure is physical fitness. It is hypothesized that patients randomized to a~     home-based training program with telemonitoring guidance will demonstrate higher levels of~     physical activity at one year of follow-up, resulting in higher levels of physical fitness,~     compared to patients who have been enrolled to the supervised center-based cardiac~     rehabilitation program or control group. Ninety patients will be randomized to Home-based~     training, a center-based cardiac rehabilitation program or an advice only group (= control~     group). Assessment will be performed at baseline, immediately at completion of the~     intervention and at one-year of follow-up and will include measurements of exercise~     tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial~     function, health-related quality.~   "
77118|NCT02047929|"~     Asthma is a common disease that affects people of all ages and has significant morbidity and~     mortality. Poor outcomes and health disparities related to asthma result in part from the~     difficulty of disseminating new evidence and paradigms of care delivery such as shared~     decision making (SDM) into clinical practice. This study will evaluate a novel mechanism for~     dissemination of an evidence-based SDM Toolkit for asthma care in primary care practices.~     The study is ideally suited to study dissemination methods because it will leverage a~     partnership between an established consortium of practice based research networks (PBRNs)~     and an advanced Medicaid Network.~      This study will evaluate a novel dissemination process (FLOW) to spread an Asthma Shared~     Decision Making Toolkit to practices within a Medicaid network using a consortium of~     practice-based research networks (NCNC). The knowledge gained from this proposal and the~     partnerships formed between practice-based research networks and NC Medicaid will facilitate~     widespread dissemination to almost 300 practices.~   "
77119|NCT02047916|"~     The current definitions of neonatal shock/circulatory failure are outdated and inaccurate.~     This makes the development of evidence based protocols for its treatment very difficult.~     Furthermore these definitions often rely on invasive methods of monitoring in patients such~     as an arterial line. Since the advent of functional echocardiography in neonatology there~     has been increased interest in non-invasive measurements of neonatal circulatory failure.~     However research in this field has been confined to premature infants.~      The purpose of the this research is to look at non invasive methods of assessing an infants~     circulatory status in infants older than 33 weeks gestational age in order to fill the~     knowledge gap here and help in the development a new definition of neonatal circulatory~     failure.~   "
77120|NCT02047903|"~     This observational study will investigate the efficacy, safety, tolerability and symptom~     control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally~     advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the~     treating physician has decided to initiate treatment with GIOTRIF in first line according to~     the local label, will be followed up for approximately 24 months.~   "
77121|NCT02047890|"~     This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety,~     tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in~     Japanese subjects with advanced malignancies.~   "
77122|NCT02047877|"~     The purpose of this study has two major goals: 1) to measure the amount of two specific~     hormones interleukin (IL)-10 and interleukin (IL)-12p70 in mucous and blood; and 2) compare~     the hormone levels in two specific areas of the lung called the trachea (upper airway) and~     the bronchioles (lower airway). The hormones IL-10 and IL-12p70 are cytokines, special~     hormones cells use to communicate with each other during inflammation or infection.~     Cytokines can be measured in mucous and blood. The balance of one cytokine compared to~     another help doctors to understand how people respond differently to infection.~     Unfortunately, the amount of IL-10 and IL-12p70 is not known in children, especially~     children with a lung infection. In addition, we do not know if the balance of these~     cytokines differ in various regions of the lung. We believe the balance of IL-10 and~     IL-12p70 is similar whether measured in the upper or lower airways.~   "
77123|NCT02047864|"~     Osteoporosis is an important health problem, costing the Canadian health care system over $2~     billion per year. Loss of bone mineral and bone fragility is especially prevalent in~     postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic.~     Creatine monohydrate is a nutritional supplement that is often combined with strength~     training to increase strength and muscle mass. The investigators recently completed a pilot~     study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate~     significantly improved hip bone mineral density during a 1-year resistance training program.~     In our current proposal the investigators want to determine whether creatine combined with~     strength training can have an even larger effect on bone mineral density at the hip if given~     over 2 years in a large group of postmenopausal women (n=240). The investigators also want~     to determine whether this leads to reduced fractures in these women for up to a year after~     completing the creatine and strength training program.~   "
77124|NCT02047851|"~     The purpose of this study is to determine whether acupuncture is helpful for patients with~     joint pain associated with psoriasis~   "
77125|NCT02047838|"~     This retrospective case-control study was performed in an Academic centre for the diagnosis~     and treatment of endometriosis. It included patients with recurrent unilateral endometriomas~     who were previously operated for the same condition (cases) and patients without recurrency~     who previously underwent surgery for unilateral endometrioma (controls). The primary outcome~     of the study was to assess the impact on ovarian reserve of second surgery for recurrent~     unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum~     anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta~     estradiol level and antral follicle count (AFC).~   "
77127|NCT02047812|"~     Introduction~      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which~     are known to carry a significant risk of mortality and morbidity. Previous work has shown~     considerable inter-hospital variation in emergency laparotomy outcomes within the United~     Kingdom. It is unknown whether there are significant differences in outcomes following~     laparotomy which may be explained by differences in hospital procedural volume.~      Aims~      The aim of this study is to compare emergency laparotomy outcomes in Scotland as they vary~     by hospital procedural volume.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a set of procedure codes for emergency~     laparotomy.~      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary~     outcome measures will be 30 day readmission rate, 30 day re-operation rate and length of~     stay.~   "
77128|NCT02047799|"~     The prevalence and incidence of cardiovascular disease (such as Hypertension) increases~     exponentially with age (McDermott, 2007;) These diseases account for 30% of the global~     mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise~     healthy adults in developed countries (Holick, 2007). VD is implicated in the control of~     blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009),~     although the role of VD supplementation for prevention and treatment of the HTA is~     controversial.The purpose of this study was to investigate if VD supplement in elderly~     people reduces the levels of BP.~   "
77129|NCT02047786|"~     Introduction~      Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency~     surgical operation performed on British children. Previous investigation of outcomes~     following appendicectomy has suggested that specialist surgeons and high volume centres have~     fewer negative appendicectomies (i.e. the appendix found to be non-diseased), although~     there has not been consistent association found between hospital type or surgeon experience~     and complication rate or admission rate.~      Scotland has 3 dedicated children's surgery centres but straightforward children's surgery~     such as appendicectomy is also carried out in the country's general surgical centres.~     Appendicectomy outcome variations have not been explored in the Scottish National Health~     Service (NHS).~      Aim~      This study will compare appendicectomy outcomes in children between Scotland's specialist~     paediatric centres and general surgical centres.~      Methods~      This is a retrospective study of all appendicectomies performed in Scotland during the~     period from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It~     will use routinely collected administrative data from the Information Services Division of~     NHS National Services Scotland.~      The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate,~     30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.~   "
77130|NCT02047773|"~     From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled~     trials exploring optimum antibiotic duration for chest infections. The standard course of~     intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a~     preliminary open labelled study to assess whether it is feasible to stop treatment earlier~     (day 8 or day 11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24~     hours for the results to be processed). All patients will therefore have a minimum of 7 days~     intravenous antibiotics. The intravenous antibiotic chosen is routinely used for~     exacerbations in bronchiectasis.~      Our hypothesis is that patients could have personalised treatment and be able to stop~     antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).~   "
77131|NCT02047760|"~     There is increasing evidence that examining our eyes can tell us a lot of information about~     our health, and systemic diseases. We want to study what eyes can reveal about serious~     neurodegenerative diseases like multiple sclerosis, and motor neurone disease, by analysing~     the retinal images from a simple non-invasive eye scan, that is already being routinely used~     to provide immediate clinical information in this group of patients.~   "
77132|NCT02047747|"~     The purpose of this study is to determine the disease response, survival, and side effects~     of an experimental drug called dacomitinib in progressive brain metastases.~   "
77133|NCT02047734|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
77134|NCT02047721|"~     In this study the Investigators are examining the effects of a 12-week exercise program~     (intervention) on measures of appetite and food intake regulation in overweight to mildly~     obese healthy adults. The Investigators hypothesize that individuals who lose a significant~     amount of weight in response to the intervention will show a reduction in the brain response~     to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to~     those who do not lose weight. These changes in neuronal activity will be associated to~     physiologic and behavioral measures.~   "
77135|NCT02047708|"~     Many patients with scleroderma have damage to their kidneys caused by the disease. There is~     limited evidence for treatments to prevent this damage or stop it progressing. Blocking a~     substance in the blood called endothelin has helped treat some aspects of scleroderma. The~     purpose of this study is to see how effective a new endothelin blocker called Zibotentan is~     in treating patients who have scleroderma and have gone on to develop reduced kidney~     function as a complication. It will be given in addition to the accepted treatments used for~     scleroderma. There will be three parts to this study each for a different group of patients:~        -  ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma~        -  ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by~          scleroderma (scleroderma renal crisis) who do not require dialysis~        -  ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis~   "
77136|NCT02047695|"~     The purpose of this study is to investigate whether a particular form of migraine, migraine~     with aura, is associated with structural changes in the brain~   "
77149|NCT02047526|"~     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to~     observe clinical practice in India in managing Heart Failure patients & to check one year~     outcome in HF patients. A total of 5 visits will be conducted during the study. There will~     be a baseline visit followed by four follow-up visits to assess the outcomes~   "
77137|NCT02047682|"~     Static postures, repetitive work tasks, and work stress increase the risk for~     musculoskeletal disorders and sickness absence. Objective measurements of occupational~     loadings - EMG for muscular activity, EEG for cognitive activity, ECG for cardiovascular~     activity and heart rate variability, actigraphy for bodily movements - may provide useful~     early indicators of muscular, cognitive and cardiovascular overload.~      The aim of this study is to investigate the effect of an individually tailored~     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical~     exercises (reference group) on these risk factors in lab technicians with a history of~     work-related musculoskeletal pain.~   "
77138|NCT02047669|"~     Musculoskeletal disorders and stress of employees remain a major problem in many~     occupations. The aim of this study is to investigate the effect of an individually tailored~     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical~     exercises (reference group) on musculoskeletal pain, work disability, and stress in lab~     technicians with a history of work-related musculoskeletal pain.~   "
77139|NCT02047656|"~     This study is designed to enable optimal dose selection of LFF269 for potential future~     studies by providing additional information about the compounds safety, tolerability,~     pharmacokinetic and pharmacodynamic profiles.~   "
77140|NCT02047643|"~     Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of~     exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D).~     However, since patients with T1D often do not make exercise-related adjustments to their~     insulin regimen, our group has developed an algorithm to initiate pump suspension in a~     user-independent manner upon projecting exercise-associated hypoglycemia. The current study~     seeks to test the efficacy of this algorithm by asking users to participate in a sports camp~     while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate~     monitor (to detect exercise), which will communicate electronically to a pump shutoff~     algorithm. On one of the days the algorithm will be used, while on the other day their~     normal insulin rate will continue for comparative purposes.~      The investigators hypothesize that the use of an accelerometer-augmented computer algorithm~     for insulin pump suspension during exercise will result in significantly fewer episodes of~     hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without~     a pump suspension algorithm.~   "
77141|NCT02047630|"~     The purpose of this study is to evaluate and compare efficacy and tolerability of the~     brand-name latanoprost and one of its generic version in subjects with primary open angle~     glaucoma or ocular hypertension.~      This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are~     two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one~     eye and the generic version in the other one. In the second period, drops are switched from~     one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0~     (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of~     second period). Variations of intraocular pressure in each eye will be evaluated.~   "
77142|NCT02047617|"~     Critically ill patients frequently develop muscle weakness due to critical illness-related~     acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning~     from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased~     mortality rates. In addition, many patients continue to suffer from decreased exercise~     capacity and quality of life for months to years after the acute event.~      Besides controlling risk factors, no specific prevention or treatment exists.~     Recommendations advice to start early with active and passive exercise in critically ill~     patients (1). Having critically ill patients alert and engaged in progressive rehabilitation~     leading to mobilization, despite the use of life support therapies may reduce muscle atrophy~     and lead to improved strength and physical function (2).~      This randomized controlled trial was designed to investigate whether a daily training~     session using a tilt table, started early in stable critically ill patients with an expected~     prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps~     force and functional autonomy at ICU and hospital discharge compared to a standard~     physiotherapy program.~   "
77143|NCT02047604|"~     A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of~     Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate~     Response to Disease-Modifying Anti-rheumatic Drug(s).~   "
77144|NCT02047591|"~     The 3rd governmental plan of fighting against the pain favored the development and the~     evaluation of the efficiency of the non pharmacological methods. Its results always showes a~     lack of knowledge of these methods and the utility to pursue the researches.~      In the department of pediatric surgery of the university hospital of Limoges, the~     relaxing-touch is one of these methods which is more and more used. The healthcare staff~     noticed the beneficial effects of such an empirical method in terms of comfort and quality~     of life for the children.~      In 2011, a pilot study led in this department showed that, in spite of the usual treatment,~     the removal of the Redon's drain remains painful for 25 % of the children (score on the pain~     scale > or = 4). This result convinced the medical team to write a protocol of research from~     the following hypothesis: the implementation of a protocol of the Redon's drain removal~     associated to the relaxing touch and usual treatment could lead to a decrease of the acute~     pain for a 7 to 17 years old child.~   "
77145|NCT02047578|"~     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,~     fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.~   "
77146|NCT02047565|"~     This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2~     treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded),~     randomized, placebo controlled, sequential descending prothrombin complex concentrate dose,~     2 sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV~     will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved~     in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares~     the blinded individual treatments from open-label supplies). The study programmer and~     statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded~     for both parts of the study.~   "
77147|NCT02047552|"~     The purpose of this trial is to determine if the combination of goal directed iron~     supplementation and hepcidin mitigation can safely eliminate both the serum and bone marrow~     iron debt of anemic, critically ill trauma patients with functional iron deficiency.~   "
77150|NCT02047513|"~     NEONAX is an interventional, prospective, randomized, controlled, open label, two sided~     survival phase II studies against a fixed survival probability, with an unconnected analysis~     of the results in both experimental arms.~      Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by~     surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant~     nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post~     randomization~   "
77151|NCT02047500|"~     This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety,~     tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine~     and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or~     metastatic pancreatic adenocarcinoma.~   "
77152|NCT02047487|"~     This is a randomized, open controlled multicenter phase II clinical study. The SPSS~     statistical software estimation of sample size, selection of the initial treatment of~     locally advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve~     the desired results, considering expanding the clinical, according to the proportion of 1:1~     were randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2~     cycles of induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The~     experimental group was added with AVASTIN.~   "
77153|NCT02047474|"~     This phase II trial studies how well combination chemotherapy before and after surgery works~     in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as~     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving combination chemotherapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~   "
77154|NCT02047461|"~     This study will include a screening period, a 6-month treatment period, and a 60-month,~     long-term extension period.~   "
77155|NCT02047448|"~     The purpose of this pilot study is to determine if medication adherence is improved by a~     transitional care pharmacy practice model designed to integrate hospital and community~     pharmacists in the care and education of patients with heart failure or COPD who are~     discharged from a community hospital to home. The hospital and community pharmacists will~     collaborate with each other, the patient, and other practitioners including the primary care~     physician, nurse, and case manager to prevent and correct medication-related problems and~     attempt to improve patient outcomes especially during the error-prone transition from~     hospital to home.~   "
77156|NCT02047435|"~     Social relationships are important to people and it affects their quality of life, morbidity~     and mortality.~      This is a randomised controlled trial studying the effect of including older people with~     impaired social relationships and a perception of loneliness at workshops, at The Storm P.~     Museum - a museum about the well known Danish cartoonist Robert Storm Petersen.~      The hypothesis is, that by including older lonely people with a impaired social~     participation in these workshops, they will increase the participants health related quality~     of life. The investigators also hypothesis, that the intervention will improve the~     participants perception of loneliness, social participation and physical function.~      The intervention consist of a series of workshops at the Storm P. Museum. At these workshops~     the participants will create memory material for nursing home residents with dementia. The~     museum staff will facilitate a process of storytelling, using events, significant stories~     and artistic works by Storm P. and encourage the participants, by means of the narrative~     interview method to share similar stories from their life.~   "
77157|NCT02047422|"~     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart~     failure patients~   "
77158|NCT02047409|"~     The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve~     activity muscle is an efficient index for the prognosis of patients with heart failure.~   "
77159|NCT02047396|"~     To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction~     (MI) in the community, study the association between patterns of remodeling and biological~     pathways and examine the association between the predictors of remodeling and heart failure~     after Myocardial Infarction.~   "
77160|NCT02047383|"~     The acute respiratory infection is the fourth most common cause of hospital stay between~     elderly people. The purpose of this study is to evaluate the repercussion of hospital stay~     in hospitalized patients with a respiratory infection.~   "
77161|NCT02047370|"~     Physical therapists have traditionally included various forms of manual therapy among the~     therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the~     effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion~     and spirometric values in patients diagnosed with asthma.~   "
77162|NCT02047357|"~     To test the efficacy of an innovative affordable intervention program that can be used by~     non-specialists, including mothers and lady health workers with minimal training in low~     resource countries such as Pakistan~   "
77163|NCT02047344|"~     This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients~     with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of~     anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive~     antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An~     evaluable patient will have received at least one dose of antroquinonol and have a valid~     baseline tumor assessment. Enrollment will continue until the target number of evaluable~     patients has been enrolled.~   "
77164|NCT02047331|"~     In this study, the aim is to compare the efficacy of Periarticular multimodal drug~     injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee~     arthroplasty.~   "
77165|NCT02047318|"~     The purpose of this extension study is to determine the long-term safety and tolerability of~     an investigational treatment (LUM001) in children with ALGS who have completed participation~     in the LUM001-302 study.~   "
77166|NCT02047305|"~     Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month~     intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or~     worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months~     after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5~     years.~   "
77167|NCT02047292|"~     Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and~     normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty~     (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM~     due to the fact that prosthetic impingement between neck and acetabular liner occurs with~     wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro~     (on cadavers or sawbones) or using mathematical modeling in computer simulations. These~     studies are limited by the lack of soft tissues and muscle activations in the models. This~     study will clinically assess the effect of prosthetic head diameter on patient capability of~     performing movements which require extreme arcs of motion of the hip joint. Therefore, the~     research questions are:~        -  What role do soft tissues play in limiting ROM?~        -  Can prosthetic impingement really occur in a well positioned THA?~        -  Can a bigger head diameter alone reduce the risk of impingement?~   "
77168|NCT02047279|"~     The purpose of this study is to estimate left atrial volume reduction surgery concomitant~     with the maze procedure and mitral valve repair/replacement in patients with atrial~     fibrillation with an enlarged left atria.~   "
77169|NCT02047266|"~     The purpose of this study is to compare three different revascularization strategies in~     patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.~      The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass~     grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump~     coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral~     events (MACCE) and procedural success.~   "
77170|NCT02047253|"~     This study will test how effective the drug, Carfilzomib, reduces progression of prostate~     cancer in patients who have previously received chemotherapy and androgen inhibitors.~     Carfilzomib is approved for multiple myeloma but is not approved for prostate cancer.~     Therefore, it is considered investigational. Other approved methods of treatment for~     metastatic prostate cancer have demonstrated only modest benefits. Novel and tolerable~     agents are necessary to make further gains and extend overall survival.~   "
77171|NCT02047240|"~     We have several ways to appropriately determine renal function in healthy patients and in~     several diseases, in cirrhotic population we dont have a precise tool that has sufficient~     precision that reflects glomerular function, although it has been reported that cystatin C,~     because of its nature could improve diagnostic accuracy to determinate the renal function in~     this population.~      The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived~     formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99~     (diethylene-triamine-pentaacetate- technetium-99) as gold standard.~   "
77172|NCT02047227|"~     This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to~     assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating~     hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for~     multifollicular development as part of an assisted reproductive technology (ART) treatment~     cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European~     Society of Human Reproduction and Embryology (ESHRE) criteria.~   "
77173|NCT02047214|"~     The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and~     efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have~     glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide~     (TMZ) therapy and that has progressed following prior bevacizumab therapy.~   "
77174|NCT02047201|"~     To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy~     (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and~     neck squamous cell carcinoma.~   "
77175|NCT02047188|"~     Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular~     architecture on lesion surface.The histology of early colorectal lesions could be predicted~     under NBI view.However,its capability for estimating invasion depth remains to be~     verified.The study is based on the hypothesis:NBI can predict histology and invasion~     depth,combined with the verification of microvessel count and MMP-7 expression.~   "
77176|NCT02047175|"~     The purpose of this study is to evaluate the drug-drug interaction of~     CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)~   "
77177|NCT02047162|"~     The purpose of this study is to learn whether bismuth subsalicylate can reduce use of~     antibiotics among adults with diarrhea in Pakistan.~   "
77178|NCT02047149|"~     Prospective nonrandomized phase I study~      The purpose of this study is to determine safety and efficacy of zileuton when added to~     dasatinib in patients with chronic myelogenous leukemia (CML).~   "
77179|NCT02047136|"~     Histamine is a biologically active component that can be found in many foods and beverages.~     Intake of excessive histamine from foods or beverages, can trigger symptoms including~     urticaria. A low histamine diet has been recommended as one of the possible treatments for~     patients with chronic urticaria. There are very few studies to confirm the effectiveness of~     such diets and, to the investigators' knowledge, none from Asia where high histamine~     containing meals are often eaten (personal observations). The objective of the present study~     is to investigate the therapeutic effect of low histamine diet in relieving symptoms in~     patients with chronic urticaria with or without angioedema, and / or pruritus (U/A/P). The~     investigators hypothesize that following a low histamine diet for 4 weeks, the symptoms of~     patients with chronic U/A/P should improve.~   "
77191|NCT02046980|"~     To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid~     oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving~     the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled~     study was conducted.~   "
77192|NCT02046967|"~     Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a~     very high success rate. It works by heating and thereby obliterating the vein. Steam~     ablation is a new therapy that also works by heating and thereby obliterating the vein. The~     hypothesis of this study is that steam ablation is as effective as laser ablation, but that~     it results in better secondary outcomes (e.g., lower pain scores).~   "
77510|NCT02042833|"~     This observational study will evaluate patients' perception of treatment with~     erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis.~     Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin~     beta) will be followed for 6 months.~   "
77180|NCT02047123|"~     Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are~     the first line interventions to reduce the short-term and long-term cardiovascular risk~     factors. Due to its high content of lignans, α-linolenic acid (LNA) and fiber, flaxseed has~     a beneficial effect on CVD risk factors, components to decrease the risk of cardiovascular~     disease. Objective: To determine the effect of the consumption of flax seed yogurt on the~     women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce~     the small dyslipidemia. The investigators performed an intervention including 133 women~     (age= 25-70 years). Participants were randomly and double-blind distributed into three~     groups: Group 1 (n= 30) consumed flaxseed (FS), yoghurt (Y) and diet (D), Group 2 (n= 32)~     volunteers consumed (Y) + (D) and Group 3 (n=27) consumed only diet. All groups followed a~     limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol,~     LDL-cholesterol and triglycerides and were determined at the beginning and end of a 30-day~     test. As a result, group 1 presented significantly reduced total cholesterol levels.~     Correlation analysis indicated that the intake of (FS) could explain the flaxseed effect of~     the variation of the cholesterol and TG in this group. Altogether, this study concludes that~     consumption FS exert a positive impact in total cholesterol level and TG~   "
77181|NCT02047110|"~     The overall purpose of the trial is to assess the clinical efficacy of three different~     subcutaneous doses of BI 655066 in adult patients with AS, in order to provide clinical~     proof of concept and to select dose (s) for confirmatory clinical trials.~   "
77182|NCT02047097|"~     The primary objective of the study is to determine the incidence, type, and pattern of~     serious adverse events (SAEs), including but not limited to infections (including~     opportunistic infections), hepatic events, malignancies, and renal events, and of adverse~     events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl~     fumarate (DMF). Secondary objectives of this study in this population are as follows: To~     determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical~     practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl~     fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in~     routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score~     and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl~     fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work~     productivity.~   "
77183|NCT02047084|"~     Given the propensity for venous leg ulcers to become refractory, long standing lesions,~     incorporating active biologic grafts into the standard compression therapy, has shown to~     accelerate wound healing.~      The two products to be compared in this study are both commonly used for the treatment of~     venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for~     the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg~     ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen~     matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human~     foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify.~      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,~     from an organ donor who has cleared the standard safety screenings. It is classified by the~     FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA~     specifications, and cryopreserved, until it is delivered to the clinic for application to~     the foot ulcer. It is also a widely used treatment for diabetic foot ulcers.~      TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a~     substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of~     lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the~     United States is compression therapy combined with application of biologic graft materials~     to the wound bed.~      This study may assist physicians who treat VLU's by comparing efficacy and costs of two~     commonly used biologic graft materials for VLU's in a randomized prospective study. In~     addition to standard compression therapy, this investigation will be a head-to-head study~     comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin~     allograft (Theraskin). There is no randomized, prospective data comparing these two graft~     options in the treatment of VLU's.~   "
77184|NCT02047071|"~     The purpose of this study is to determine whether Continuous Positive Airways Pressure~     (CPAP) improves quality of life, cardiovascular (blood pressure) and metabolic profile~     (glucose and lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea~     (OSA).~   "
77185|NCT02047058|"~     The purpose of this study is to determine whether Q cells separated from the glioma sample~     are determinants in treatment response and prognosis of glioma patients~   "
77186|NCT02047045|"~     This trial is primarily aimed to compare the effect and safety of electro-acupuncture and~     prucalopride for severe chronic constipation: if the short-term effect of~     electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also~     mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture~     can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.~   "
77187|NCT02047032|"~     A noninferiority randomized controlled trial aimed at comparing the effect and safety of~     electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed~     urinary incontinence (MUI).~   "
77188|NCT02047019|"~     This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106~     (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate~     control of blood pressure with candesartane alone.~      Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five~     weeks of the study to assess blood pressure control with candesartan given alone.~      Patients with an insufficient therapeutic response to candesartan alone (defined by mean~     seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will~     be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine~     / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor~     the treating physician will know which treatment is given (double-blinded design).This part~     of the study will last eight weeks.~   "
77189|NCT02047006|"~     Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and~     treatment of thromboembolic disease. There are no data on dose adjustments in patients with~     severe chronic renal failure. It's use is therefore not recommended in this patient~     population. The present study aims to asses in 12 hemodialysis patients that require~     prevention of deep vein thrombosis:~        1. the AUC and Cmax of 10 mg rivaroxaban~        2. the effect of 10 mg rivaroxaban on coagulation assays~        3. the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa~          levels~        4. the safety and tolerability of rivaroxaban~   "
77190|NCT02046993|"~     To test the hypothesis that hypertensive patients who participate in smart phone based~     telemonitoring of BP will conduct more home blood pressure monitoring, better self~     management behavior and greater reduction in blood pressure and better self management~     behaviour from baseline to 6 months follow up than those patients receiving enhanced usual~     care.~   "
77193|NCT02046954|"~     Compromised tissue oxygenation during surgery may negatively influence patient outcome.~     Primary cause of insufficient tissue oxygenation is reduced cardiac output due to~     hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially,~     postoperative pericardia effusion and/or tamponade may further compromise cardiac function.~     Today, hemodynamically instable patients are often monitored by means of pulmonal artery~     catheters or transpulmonary thermodilution. However, these methods only allow quantification~     of functional limitations. Underlying causes may be investigated by relatively recent~     technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R)~     ImaCor) that also provide the possibility of continuous monitoring. It has been reported~     that a training program consisting of six hours may enable physicians who are unexperienced~     in the field of echocardiography to apply this new method. Up to now, there is no evidence~     whether this methods is associated with improved postoperative outcome.~      Therefore we hypothesize that continuous hemodynamically focussed transesophageal~     echocardiography positively influences patient outcome (primary hypothesis). Furthermore,~     its application may decrease hospital expenses (secondary hypothesis).~   "
77194|NCT02046941|"~     The study will use MRI brain imaging to identify brain changes associated in stroke patients~     after they receive speech-language treatment for their speech difficulties.~   "
77195|NCT02046928|"~     This study will assess the efficacy, safety and pharmacodynamic markers of the study drug,~     A6, in patients with CLL and small lymphocytic lymphoma (SLL).~   "
77196|NCT02046915|"~     Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens~     combining novel agents and alkylating agents. However, in applying this approach the~     patients are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates~     significant activity in combination with Dexamethasone in relapsed or refractory multiple~     myeloma. This trial is an attempt to further improve the efficacy of~     Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of~     Cyclophosphamide in the treatment in case of suboptimal response or first evidence of~     progressive disease has the aim to significantly increase duration of treatment that should~     have a positive impact on PFS. It is furthermore an attempt to optimize the potential of~     Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a~     disease with a wide clonal heterogeneity, combination treatment in case of suboptimal~     myeloma control might lead to a more effective suppression especially of aggressive~     subclones and might reduce early resistance. In addition, with the goal of keeping the~     individual patient as long as possible under an effective IMiD treatment, the potential of~     the drug might be optimized according to the current view of maintenance treatment resulting~     ideally in an outgrowth of indolent clones in the bone marrow niche.~   "
77197|NCT02046902|"~     The goal of this study is to gather input from patients who have undergone PCI, their family~     and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the~     decision aid is to deliver information, including individualized estimates of patients'~     restenosis risk, in an understandable format that would be informative and assist in~     decision-making for patients undergoing PCI.~   "
77198|NCT02046889|"~     The objectives of this study are to 1) demonstrate the effectiveness of the innovative~     bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel~     bike, and 2) determine the effects of the treatment on health related performance measures,~     physical activity level, patterns of sleep behavior, psychosocial outcomes, and community~     participation. The hypotheses to be tested in this study are: 1) there will be a significant~     treatment group difference (EXP vs CON) in the number of participants who demonstrate the~     ability to ride a two wheel bicycle in favor of the EXP group following the first year of~     training. 2) At the end of the second year of training when the CON group receives the~     bicycle training program, there will not be a group difference in the number of riders who~     learned to ride. 3) At the end of the first year, there will be a significant treatment~     group difference (EXP vs CON) on the health related performance measures, average time spent~     in moderate and moderate to vigorous physical activity, patterns of sleep behavior (sleep~     onset, frequency of night waking), self and parent perceptions of bicycle riding ability,~     and community participation (number of community activities engaged in, frequency of~     community participation, number of people they participate with outside of the parents, the~     number of community locations in which they participate), in favor of the EXP group. 4) At~     the end of the second and third year, the CON group will demonstrate a significant~     improvement in all of these measures (a significant improvement from the pre-training~     measures to the 12 and 24 month measures). 5) At the end of the third year, the EXP group~     will demonstrate a significant group difference on all measures compared to the CON group~     but the magnitude of the difference will be less than was observed in hypothesis 3 at the 12~     month measurement before the CON group received their training. These hypotheses will be~     tested separately for the DS and ASD groups.~   "
77199|NCT02046876|"~     Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of~     the neck with an establishment and/or persistence period of over 12 weeks.~      The socio-economic system is seriously affected by chronic neck pain due to direct and~     indirect costs on the health system Physical exercise is used to improve physical function~     and reduce the symptoms of pain and stiffness due to chronic neck pain.~      It has been demonstrated that therapeutic exercise in water is effective to improve~     functional capacity and symptoms in patients with chronic neck pain. In adition, health~     education and posture is an important component of the overall treatment of neck pain.~      Interventions that integrate physical activity, adapted swimming and health education as an~     intervention for chronic neck pain sufferers have not been found. Furthermore the aim of~     this study is to analyse the effect of a physiothperapy treatment that combine adapted~     swimming, therapeutic exercise and health education in patients with chronic neck pain.~      Hypothesis: the present intervention will be an effective tool to treat patients suffering~     chronic neck pain.~      Methods: chronic neck pain patients from a community-based centre will be recruite~     participate in this prospective study.~      Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor~     control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with~     aerobic exercise keeping neutral neck position by using a snorkel. Health education will be~     provided by the physiotherapist before and during the sessions using a decalogue on chronic~     neck pain and constant repetition of brief advice.~      Study outcomes: disability (Neck Disability Index), physical and mental health state and~     quality of life of patients (SF-12 and EuroQoL 5D respectively).~      Differences between baseline data and that at the 8-week follow-up were calculated for all~     outcome variables.~      Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the~     variables using the KS-test. Comparison of variables pre - post intervencición: T-Student~     for parametric variables and Wilcoxon test for non parametric variables.~      Data will be analysed descriptively and for statistical significance using Statistical~     Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).~   "
77200|NCT02046863|"~     The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders~     such as Parkinson's disease has been well established; however, there is a great disparity~     in outcomes among DBS recipients due to varied postoperative management, particularly~     concerning the choosing of an optimal set of programming parameters from the thousands of~     possible combinations. This study will evaluate the use of motion sensor based assessments~     to develop a functional map and algorithms to automatically determine a set of programming~     parameters that maximize symptomatic benefits while minimizing side effects and battery~     consumption.~   "
77201|NCT02046850|"~     Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244;~     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers~   "
77869|NCT02038140|"~     The primary objective of this study is to obtain implant survivorship and clinical outcome~     data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary~     or revision total ankle arthroplasty. The assessment will include implant survivorship and~     clinical performance measured by pain and function, quality of life data, radiographic~     parameters and survivorship.~   "
77202|NCT02046837|"~     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive~     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC~     but has many side effects. Researchers have shown that exercise, specifically one-on-one~     supervised exercise improves many of the side effects of ADT. However, exercise programs for~     men on ADT are not widely available. More questions need to be answered in order for~     exercise programs to become part of PC treatment. First, can programs that require fewer~     resources, such as group-exercise or home-based exercise, also improve ADT side-effects?~     Second, do exercise-related benefits continue beyond the structured exercise program? And~     what makes people continue exercising? Third, which exercise program is most cost-effective?~      In this study, the investigators will compare: (a) group supervised in-centre; (b)~     home-based supported; and (c) 1:1 supervised in-centre exercise programs to see which~     program is most effective for men with PC on ADT. The investigators will also look at what~     motivates people to continue to exercise both during a structured program and after the~     program is complete and will examine which exercise program is most cost-effective.~      The investigators will ask men with PC on ADT that are being treated at either Princess~     Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate~     in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3~     exercise programs. All programs will include the same type of exercises (aerobic, resistance~     and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day~     (as tolerated) for the length of the program (6 months). The investigators will look at how~     men with PC on ADT respond to the exercise program by measuring quality of life (QOL),~     fatigue and different physical measures before, during, and after the exercise program.~      Although the investigators know that supervised one-on-one exercise is most effective at~     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial~     and more financially responsible. This study will allow the investigators to begin to answer~     these questions so that structured exercise programs become a regular part of PC treatment.~   "
77203|NCT02046824|"~     Cell savers are routinely used in our hospital during off-pump coronary artery bypass~     grafting to retrieve and wash blood that is lost during the operation. This washed blood is~     retransfused to the patient in order to prevent allogeneic blood transfusion. However,~     little is known about the rheologic properties and oxygen transport capacity of the washed~     red blood cells and the effects of retransfusion of this blood on microcirculatory blood~     flow and organ damage in the patient. For cell savers 3 different operating principles~     exist. The most common one uses discontinuous blood washing with a spinning bowl that is~     intermittently filled with blood, processed and emptied. A second one uses a continuous~     blood washing principle with a rotational disk. A third one is intermediate using features~     of both the discontinuous bowl technology and the continuous rotational disc technology.~      The investigator hypothesize that the operating principle has effects on the rheologic~     properties and oxygen transport capacity of the washed blood.~      Previous research suggested that in particular the deformability and oxygen carrier~     properties of the red blood cells are affected. As a consequence, red blood cells may block~     small blood vessels, which affects microcirculatory blood flow and tissue oxygenation. This~     may lead to organ damage.~   "
77204|NCT02046811|"~     The objective of this study is to determine the impact of a 12-month patient activation and~     education intervention on skin cancer early detection practices among childhood cancer~     survivors treated with radiation. This randomized controlled trial uses a three-group~     design.~      Our specific aims are to: (1) Determine the impact of a Patient Activation and Education~     intervention with and without physician activation and teledermatology on skin cancer early~     detection practices, (2) Determine the impact of the intervention on time to diagnosis, and~     (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.~   "
77205|NCT02046798|"~     This study measures how much of the trial drug enters the body and how long it takes for the~     body to remove it via the feces and urine. In addition, the different breakdown products~     after a single oral dose of radio-active ASP3652 will be identified.~   "
77206|NCT02046785|"~     The purpose of this study is to determine whether hemodynamic measures vary in angles~     bedside before and after volume challenge.~   "
77207|NCT02046772|"~     A single blind, randomized, with blinded evaluation by third parties clinical trial is~     carried out to assess the analgesic efficay of the addition of morphine chloride to a low~     dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in~     the haemorrhoid surgery.~      The objective of this clinical trial is to assess if the experimental treatment is as~     efficacy as the standard treatment in the anesthetic and analgesic effects with less side~     effects, greater and earlier mobility after surgery and shortened the hospitalization.~   "
77208|NCT02046759|"~     The aim of the study is to compare the effect of asthma care by clinical pharmacist~     intervention versus routine care on asthma control.~   "
77209|NCT02046746|"~     The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids~     in maintaining nutritional status.~   "
77210|NCT02046733|"~     Despite the fact that the majority of the patients with limited disease SCLC will respond~     very well to the standard treatment, a great proportion will relapse within 12 - 24 months.~      Several studies in patients with lung cancer suggested a possible favourable association~     between the increased presence of immunologically active cells in the tumour and survival.~     Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy~     cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have~     shown activity in a broad range of cancers, including SCLC.~      The aim of the current study is to investigate the efficacy (how well the treatment works)~     and tolerability (how severe the side effects are) of the standard treatment (chemotherapy~     and radiotherapy) alone, compared with the standard treatment followed by nivolumab and~     ipilimumab in patients with limited SCLC.~   "
77241|NCT02046330|"~     We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients~     with treatment refractory depression (TRD). Data from the University of Bonn indicates that~     surgical lesions of the medical forebrain bundle can produce therapeutic benefits in~     patients with depressive disorders, and suggest that DBS at the same site may also reduce~     symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the~     US population and of those at least 10-15% do not benefit from therapies hence why we must~     explore new treatments. The Activa® systems manufactured by Medtronic Neurological will be~     used in this study. Study subjects will be between the ages of 22 and 65 years of age and~     suffer from TRD, have failed multiple treatment regimens, including ECT, and remain~     symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot~     study investigating DBS, targeting the MFB.~   "
77282|NCT02045797|"~     GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II~     Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study~     designed to select the optimal dose by further characterizing the safety, tolerability and~     PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care~     to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure~     infections (ABSSSI). The selected dose will be used in future studies.~   "
77211|NCT02046720|"~     The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation.~     Numerous studies in adults have shown good correlation between bispectral index values and~     depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and~     inhalational hypnotic agents to suppress consciousness decrease with age. A study showed~     that the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane~     in elderly than in young adults, but at identical BIS values, so that BIS would predict~     depth of sedation better than drug monitoring. This result incited the use of bispectral~     index monitoring to overcome the significant pharmacological variability, especially in~     elderly. Nevertheless, another research with a comparable methodology during~     propofol-induced anaesthesia provided higher BIS values at LOC in elderly compared to~     younger patients. In these two trials, LOC was defined differently: either by absence of~     verbal response corresponding to loss of eyelash reflex (LOER) or by absence of response to~     prodding [(OAA/S) <2)]. Otherwise electromyographic activity (EMG) was not taken in account.~     As high EMG level (greater than 50 decibels) could create subtle artifact signal pollution~     without necessarily being displayed as artifacts, this would be misinterpreted by the BIS~     algorithm as EEG activity and assigned a spuriously increased BIS value.~      The main objective of our study was to specifically evaluate BIS values according to age~     during propofol-induced sedation. LOC was measured by obtaining an OAA/S score <2 (OAA/S2),~     or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was~     to specify the influence of EMG on the displayed BIS values and its age-related~     modifications.~   "
77212|NCT02046707|"~     This is a single-centre open randomized parallel-group study. Patients will be selected at~     random to be included in group 1: eccentric rehabilitation or group 2: conventional~     rehabilitation.~      In addition, a group of healthy volunteers aged between 20 and 85 years will also be~     recruited. This group will make it possible to evaluate, during the two exercise sessions,~     mechanisms of adaptation linked to eccentric exercise vs concentric exercise.~   "
77213|NCT02046694|"~     This research is being done to determine if allopurinol can change the metabolism of the~     oral chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute~     lymphoblastic leukemia (ALL). 6-MP is originally started at a standard dose in children with~     ALL, but the dose is adjusted according to the absolute neutrophil count (ANC).~     Occasionally, 6-MP doses need to be increased in order to get the ANC into a specific target~     range. Also, increasing the 6-MP dose can lead to unwanted side effects, such as~     inflammation of the liver as shown by increases in laboratory values (ALT, aspartate~     aminotransferase (AST), bilirubin), nausea, and abdominal discomfort. Previous studies in~     children with inflammatory bowel disease has shown that combining allopurinol with 6-MP can~     decrease side effects associated with high doses of 6-MP and also increase the efficacy of~     6-MP. Allopurinol is approved by the Food and Drug Administration for the treatment of tumor~     lysis syndrome in ALL. Through this research study, we hope to show that the combination of~     allopurinol and 6-MP will be safe, tolerable, and effective in children with ALL.~   "
77214|NCT02046681|"~     Half of the people over the age of 65 are not functioning at their optimal level because of~     interference from pain. > 50% of older adults had taken prescriptions of pain medication~     beyond a 6-month period. In Emergency Department 80% of visits involving conditions with~     painful component. The study aims to observe and check side effects of most frequently pain~     killers prescribing at home to patients over 65 years old after a visit in emergency~     department.~   "
77215|NCT02046668|"~     This pilot study will obtain preliminary evidence on which to base sample size calculations~     for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in~     older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone~     is known to be pro-inflammatory, and spironolactone suppresses cytokine production in~     chronic arthritis. This application builds on previous work by the applicants showing that~     spironolactone significantly improved quality of life (particularly pain) in frail older~     people. The investigators will recruit 86 people (aged 70 years or over) with well-defined~     OA knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary~     outcome is the between group difference in change in WOMAC pain sub-score at 12 weeks.~     Secondary outcomes are the WOMAC stiffness and physical function subscales and health~     related quality of life (EQ-5D). Morning cortisol levels will be measured to assess the~     effect of mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate~     the anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix~     metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the~     effects of pharmacological interventions for osteoarthritis.~   "
77216|NCT02046655|"~     Corifollitropin alfa has been shown to result in significantly more oocytes compared to~     daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due~     to the higher circulating FSH activity during the first days of stimulation. For this~     reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the~     number of oocytes retrieved is crucial for success.~      The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment~     compared to daily recFSH in terms of the number of oocytes retrieved in a defined population~     of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using~     gonadotrophin releasing hormone (GnRH) antagonists.~   "
77242|NCT02046317|"~     For bone fracture injuries, particularly femur fractures, the femoral nerve block (FNB) can~     provide a fast and effective means to control pain. However, this method is not always~     employed due to the fact that positioning the needle and therefore the block can be time~     consuming and challenging, and if not precisely placed, the nerve block results in poor pain~     control. Traditional methods for nerve blockade include the blind technique and use of a~     peripheral nerve stimulator (PNS). Unfortunately, neither of these methods provide a~     reliable guide for needle placement and can lead to intraneural placement and/or failed~     attempts.~      Hypothesis: When ultrasound technology is implemented in this procedure it may improve the~     success rate when compared to other techniques by providing real-time visual guidance. This~     may result in a faster and prolonged pain relief reducing the amount of analgesics needed.~   "
77243|NCT02046304|"~     The goal of this clinical research study is to find the highest safe dose of gemcitabine~     that can be given with radiotherapy before surgery to treat sarcoma. This study will also~     look at how well this treatment controls sarcoma.~   "
77217|NCT02046642|"~     Maternal rest in left lateral decubitus position increases fetal urine production rate which~     in turn increases the estimated amniotic fluid volume (AFV) in uncomplicated pregnancies.~     The estimated AFV increases faster at initial periods, particularly during the first, second~     and third 15 minute periods of the maternal rest in the left lateral position. Although at~     each successive 15 minute period the estimated AFV continues to increase, the increase rate~     is always less in the following period. The AFV increase curve resembles the characteristics~     of a saturation curve and finally the estimated AFV increase stops approximately at the~     second hour.~      Although maternal rest in left lateral decubitus position increased the estimated AFV in the~     previous studies, the sole effect of left lateral position or the sole effect of rest was~     not evaluated, and the results of resting in another position is not known. In addition, it~     is hard for a pregnant woman to maintain the left lateral position continuously.~      Rest in the prone position is not practical for a pregnant woman, particularly after the~     first trimester of the pregnancy and supine position may cause several hypotension related~     symptoms including nausea, anxiety, lightheadedness, shortness of breath, perspiration,~     tachycardia and urge to change position. Thus, right lateral position may be an alternative.~      The purpose of this study is to analyze the effect of maternal rest in the right lateral~     decubitus position on estimated amniotic fluid volume in comparison with the left lateral~     position. Because, in both groups the mothers rested, our secondary aim was to obtain data~     for the contribution of maternal rest to the AFI increase observed in the previous studies.~   "
77218|NCT02046629|"~     Primary Objective:~      To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of~     14 mg administration in Chinese healthy subjects~      Secondary Objective:~      To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in~     Chinese healthy subjects~   "
77219|NCT02046616|"~     This open-label, single-arm study will evaluate the safety, efficacy, and tolerability of~     subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy or in combination~     with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs)~     in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients~     will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks.~   "
77220|NCT02046603|"~     This open-label study will evaluate the efficacy and safety of RoActemra/Actemra~     (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic~     DMARDs in patients with active rheumatoid arthritis and an inadequate response to to current~     non-biologic DMARD therapy or the first anti-TNF agent. Patients will receive~     RoActemra/Actemra 162 mg subcutaneously weekly for 52 weeks.~   "
77221|NCT02046590|"~     There is a worldwide trend to minimally invasive interventions, which results in increasing~     numbers of interventions performed outside of the operating room. Currently, approximately~     12 to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this~     anaesthetic activity is increasing.~      Many of these interventions need supplementary comfort measures to have relaxed patients and~     high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed~     >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that~     needs patient sedation.~      There is a controversy about the optimal comfort intervention in minimally invasive~     interventions and in particular in ERCP. Two different approaches to insure patients'~     comfort have been proposed: general anaesthesia with endotracheal intubation and mechanical~     ventilation or sedation with spontaneous ventilation.~      Well-performed studies on sedation versus general anaesthesia using a randomized controlled~     trial design with observer blinding will contribute to improve the decision-making for the~     optimal comfort measures in minimally invasive procedures. At our knowledge such a~     randomized controlled trial has not been reported before. The investigators hypothesize that~     deep sedation without tracheal intubation will achieve similar success rates for ERCP as~     general anaesthesia and will have similar rates of harmful postoperative effects.~      The primary aim of this trial is to demonstrate that the success rate of ERCP is not~     inferior in patients randomized to deep sedation without orotracheal intubation vs general~     anesthesia with orotracheal intubation. Secondary aims include a comparison between~     randomization groups of patient safety, patient and endoscopist satisfaction, duration of~     patient recovery and of anesthesia procedure.~   "
77222|NCT02046577|"~     The main purpose of this study is to determine whether weekly oral vitamin D supplementation~     is effective to prevent acute respiratory tract infections in children. The hypothesis of~     the study is that vitamin D supplementation reduces the incidence and severity of acute~     respiratory tract infections in children.~   "
77223|NCT02046564|"~     To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination)~     compared to sertraline monotherapy in patients with major depressive disorders who have~     responded incompletely to sertraline monotherapy.~   "
77224|NCT02046551|"~     The purpose of this study is to evaluate atomoxetine's effects on the rewarding and~     reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise~     healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the~     negative effects of nicotine.~   "
77225|NCT02046538|"~     The purpose of this study is to establish the safety of Zaltrap in patients who undergo~     pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my~     impact colorectal cancer growth and metastasis.~   "
77226|NCT02046525|"~     Ten healthy volunteers will be recruited to receive either an autologous stool transplant or~     a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,~     and safely, restore a patient's fecal microbiome after antimicrobial exposure.~   "
77227|NCT02046512|"~     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus~     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in~     patients on broad spectrum antimicrobials.~   "
77228|NCT02046499|"~     This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the~     prevention of post partum haemorrhage in patients undergoing caesarean section~   "
77244|NCT02046291|"~     This is a single institution, phase I dose escalation study of weekly romiplostim post~     umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by~     day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive~     measurements without transfusion for 7 days. Romiplostim is administered at the assigned~     dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6,~     8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of~     romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this~     CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum~     toxicity rate of 20% or less.~   "
77245|NCT02046278|"~     A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of~     the anal verge.~   "
77283|NCT02045784|"~     The objective of this study is to define the amount of dietary iodine needed per day during~     the first six months of life. The hypothesis is that the current recommended iodine intake~     in infants is set too high.~   "
77229|NCT02046486|"~     This is a single-center, prospective, randomized, single-blind, investigator initiated,~     pharmacokinetic/pharmacodynamic study of parallel design.Patients with ST elevation~     myocardial infarction (symptom onset<12 hours), undergoing primary percutaneous coronary~     intervention, who are P2Y12 inhibitor naïve, will be randomized after informed consent,~     immediately after diagnostic coronary angiography, in a 1:1 ratio to either:~        -  Ticagrelor 180mg loading dose, in the form of 2 whole tablets administered per os in~          the supine position (standard administration)~        -  Ticagrelor 180mg loading dose, in the form of 2 tablets crushed and dispersed in~          purified water and administered per os with 1-minute-stay in a 60-70 degrees~          semi-upright sitting position Platelet reactivity assessment will be performed at~          randomization (Hour 0) and at 0.5, 1, 2, 4 and 6 hours after randomization, using the~          VerifyNow assay, in platelet reactivity units (PRU). The cutoff >208 PRU will be used~          for definition of high platelet reactivity (HPR). All platelet reactivity assessments~          will be performed by a physician blind to the actual treatment given. Additional blood~          samples will be collected at the same time points for pharmacokinetic analysis. These~          samples will be collected in vacuum tubes with lithium heparin and will be kept in ice~          until centrifugation (3000 rpm at 4°C for 10 min, within 30 min of sampling). The~          resultant plasma will be transferred into a plain polypropylene tube (screw cap) and~          stored at or below -20°C until analysed.~   "
77230|NCT02046473|"~     To determine if ultrasound measurements can accurately measure the blood pressure of flow~     across a stent that has been placed in a portal vein to reduce portal vein pressure known as~     Transjugular Intrahepatic Porto-Systemic shunts or TIPS.~   "
77231|NCT02046460|"~     The primary objective is to demonstrate the non-inferiority of treatment with ASA to~     anti-coagulant treatment with vitamin K antagonists in patients after a cervical artery~     dissection (CAD).~   "
77232|NCT02046447|"~     The main purpose of this study is to investigate primary cervical dystonia as compared to~     healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by~     examining cognitive measures, physical measures, and structural and functional magnetic~     resonance imaging (MRI).~      The secondary aim of this study is to investigate a specific drug therapy for primary~     cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug,~     trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by~     physicians as a treatment for symptoms of primary cervical dystonia.~   "
77233|NCT02046434|"~     This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if~     phenylbutyrate can increase the removal of alpha-synuclein from the brain into the~     bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is~     believed to cause the death of brain cells, leading to Parkinson's Disease.~   "
77234|NCT02046421|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and~     mifepristone when given together with carboplatin in treating patients with breast cancer~     that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian~     epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such~     as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Steroid hormones~     can cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast~     and ovarian cancer by lowering the amount of steroid hormone the body makes. Giving~     carboplatin and gemcitabine hydrochloride together with mifepristone may be an effective~     treatment for breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.~   "
77235|NCT02046408|"~     This study tests the use of handheld computer tablets to promote the integration of 5A's~     (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community~     primary care clinics. Although most patients receive the ask and advise steps, only~     slightly more than half are assessed for readiness to change, less than half receive~     assistance in changing, and only 9% have an arranged follow-up. While the large majority~     of primary care providers support the 5A's model, negative attitudes and the lack of time,~     knowledge, and cessation skills are common obstacles. Alternate service delivery systems~     that address these obstacles and evidence-based strategies to promote their implementation~     are needed to improve provider adherence and 5A's fidelity.~   "
77236|NCT02046395|"~     The purpose of this study is to study the effect of blocking the renin angiotensin system on~     urinary free light chain excretion as compared to urine microalbumin creatinine ratio in~     subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as~     a biomarker of earlier detection of kidney function impairment in subjects with diabetes~     mellitus.~   "
77237|NCT02046382|"~     This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen~     among cesarean section patients. The study hopes to find out if patients who receive~     scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain~     scores and use less narcotic pain medication than patients who do not receive IV~     acetaminophen.~   "
77238|NCT02046369|"~     A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and~     adolescents with bipolar I depression~   "
77239|NCT02046356|"~     The investigators aim to investigate the related risk factors and the independent risk~     factors of early recurrence, the rate of disease free survival and the rate of recurrence,~     furthermore, develop a rating system of risk factors.~   "
77240|NCT02046343|"~     The purpose of this study it to determine if a promotora-led intervention that takes a~     comprehensive, multi-level, community-based approach to promoting physical activity (PA) is~     effective among a particularly underserved segment of Latinas. We hypothesize that Latinas~     in the promotora-led PA Intervention will significantly increase minutes per week of~     moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control~     group.~   "
77246|NCT02046265|"~     The project is a clinical behavioral research project based at University of Pennsylvania.~     The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and~     theory-based health promotion intervention to enhance cervical cancer prevention among young~     women ages 18-26 living in economically disadvantaged urban communities. The investigators~     will evaluate the intervention for feasibility, acceptability and preliminary efficacy.~   "
77247|NCT02046252|"~     Substance use, particularly the compulsive behaviors associated with addiction, lead to~     unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment~     failure. High on the list of disorders leading to non-adherence is heroin addiction as a~     wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would~     be improved by developing new methods to prevent relapse to heroin addiction, especially~     methods that can be used in settings that are not limited by the aims to test such a method~     using an implantable naltrexone formulation (IN) that is approved in Russia and blocks~     opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone~     (ON) because it does not depend on daily behavior to take a tablet and maintains a constant~     plasma level for months, which should result in sustained blockade, less relapse, and better~     ART adherence and treatment response.~   "
77248|NCT02046239|"~     Closure of the skin after liver resection (surgery to remove part of the liver) may be~     achieved by one of several methods. The standard method at our institution is to use~     stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous~     absorbable suture may be used to sew the skin together.~      The ideal method of closure should be safe, effective, associated with minimal patient~     discomfort and have a good cosmetic result. At present, there is no scientific evidence to~     describe which method is most suitable following liver resection.~      The primary aims of this study is to investigate which method (subcuticular sutures vs~     staples) offers the best result in postoperative rate of (1) skin infection, (2) skin~     dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we~     are interested in which method is best for patient satisfaction and cosmetic appearance and~     which method is most cost effective.~   "
77249|NCT02046226|"~     A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen~     Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb~     Ischemia.~   "
77250|NCT02046213|"~     The purpose of this study is to determine the metabolism and excretion of [14C]E2006 in~     healthy male subjects.~   "
77251|NCT02046200|"~     Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the~     development of effective treatments for AUDs represents an important public health~     objective. Repositioning, i.e. using existing approved drugs for other indications,~     represents a fast and economically feasible approach for drug development. Ivermectin (IVM)~     is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in~     mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this~     project is to provide key clinical evidence that IVM can be repositioned as a novel~     therapeutic agent to treat AUDs.~   "
77252|NCT02046187|"~     This study aims to see if reducing blood sugar and increasing ketones (a metabolic product~     that comes from using fats for energy) can increase survival and enhance the the effects of~     standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM).~     These changes occur from use of a ketogenic diet. This research has 2 goals:~        1. Show that patients can tolerate the diet and maintain low blood glucose and high blood~          ketone levels.~        2. Show if this diet enhances the effectiveness of standard treatment by prolonging~          survival of patients with a GBM.~   "
77253|NCT02046174|"~     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for~     patients with advanced colorectal cancer that no longer responds to standard therapies.~      The treatment is being evaluated for its effect on tumor growth. It consists of the~     placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA~     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or~     stop the growth of tumors in experimental animals and veterinary patients. It has been~     tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase~     II studies in patients with colorectal, pancreatic or prostate cancers are in progress~   "
77254|NCT02046161|"~     The quality of colon preparation plays a crucial role in colon cancer prevention, especially~     for right side colon. So far, colon cleansing is still not adequate in up to 10-30%~     colonoscopies and leads to increase risk of missed neoplasm.Recent literature on colonoscopy~     preparation revealed the dosage, timing and dietary restriction could influence colon~     preparation quality. Previous study demonstrated colon cleansing on the day of colonoscopy~     had better cleansing quality. However, the ideal colon preparation is not yet determined.~     the investigators herein consider the in-hospital setting of colon cleansing room can ensure~     better colon cleansing timing, colon preparation evaluation reliability and patient's~     compliance of colon cleansing. Therefore, the investigators design a prospective randomized~     controlled trial to compare cleansing quality between the setting of colon cleansing room~     and the standard colon preparation.~   "
77255|NCT02046148|"~     Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in~     healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific~     antibodies in infants, placental transfer from the pregnant women to the infant and levels~     of antibodies in the breast milk.~   "
77256|NCT02046135|"~     The proposed study will investigate the effect of sodium bicarbonate on the prevention of~     acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The~     investigators hypothesize that the occurrence of acute kidney injury will be less in~     children treated with sodium bicarbonate in the perioperative period when compared to~     placebo. The specific aims of this proposal are as follows:~      1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in~     pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium~     bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To~     examine whether treatment with sodium bicarbonate modifies the duration of acute kidney~     injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney~     failure. 3. To determine the relevance of NGAL as a biomarker to predict development of~     acute kidney injury.~   "
77280|NCT02045823|"~     To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the~     commercially available iVue and NW-300. Also, to demonstrate clinical substantial~     equivalence of 3D OCT-2000 Maestro as comparable to the commercially available NW-300.~   "
77281|NCT02045810|"~     Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption.~     It has not been tested on small children. The aim of this study is to measure, whether there~     is a difference in nosiception measured by SPI in a group receiving local anesthetics prior~     to operation compared to group receiving plasebo.~   "
77257|NCT02046122|"~     The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from~     HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease~     (GVHD) or increased treatment-related mortality. The Investigator further believes that this~     will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy~     alone, and that that this benefit will be even greater in donor-recipient pairs that share~     maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large~     part of this trial will include immune function assays as well as assessments of efficacy,~     toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic~     hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator~     will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with~     biologic correlates (cytokine and genomic profiles) and clinical outcomes.~   "
77258|NCT02046109|"~     The objective of this trial is to compare the success (as assessed by a pre-defined set of~     outcome) of failing composite resin restorations that are repaired using diamond bur induced~     surface abrasion, to those that are completely replaced.~      It is hypothesized that both treatment will have comparable success rate.~   "
77259|NCT02046096|"~     This prospective, multicenter, single-arm clinical study will further evaluate the safety~     and effectiveness of Cook's permanent and retrievable inferior vena cava (IVC) filters~     (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in~     patients in need of temporary or permanent IVC filter placement for the prevention of~     pulmonary embolism.~   "
77260|NCT02046083|"~     The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction~     of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the~     interest of a prolonged maintenance therapy~   "
77261|NCT02046070|"~     This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple~     Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and~     who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age~     (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma~     (RRMM)).~   "
77262|NCT02046057|"~     The purpose of the study is to determine if it is possible to identify and perform a needle~     biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in~     the lymph nodes under the arm without making an operation necessary.~      The rationale for this study is that for patients without enlarged lymph nodes under the~     arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has~     spread to the lymph nodes under the arm. While the complications from a sentinel lymph node~     dissection are less than that of a complete axillary lymph node dissection, sentinel lymph~     node dissection still carries small risks of arm swelling, decreased movement, fluid~     collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do~     not contain cancer. The investigators hope to develop a method to find cancer in the~     axillary lymph nodes and avoid the complications of an operation.~   "
77263|NCT02046044|"~     Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure~     patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate~     70 beats per minute or higher, and who are taking maximal dose of a beta blocker if~     tolerated.~   "
77264|NCT02046031|"~     To explore the rule of absorption, distribution, metabolism and elimination after~     intravenous administration of Ginkgolides Meglumine Injection healthy subjects. The plasma~     drug profiles will be important to assess the potential clinical drug-drug interactions.~   "
77265|NCT02046018|"~     In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness~     (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments,~     since health access and human resources are limited. Healthy Child Uganda (HCU) is a~     Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a~     Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers,~     provide health education and refer sick children. Volunteer retention (94%) and significant~     decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to~     provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics,~     and antimalarials. Use of lay providers in this capacity, called integrated community case~     management (iCCM), has been proposed as a potential inexpensive solution to SSA's human~     health resource crisis.~      PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve~     the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and~     fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to~     prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV~     retention/motivation; program cost. Selected VHV will be iCCM trained then receive~     treatments for distribution. Qualitative and quantitative methods including household~     surveys, and focus groups will consider pre/post intervention differences and differences in~     control and intervention populations. A research short course and micro research grants (~~     $3000 to multidisciplinary groups pursuing relevant questions) will promote health system~     evaluation capacity. Lessons learned are critical as SSA countries move forward in planning~     for increased iCCM programming.~   "
77266|NCT02046005|"~     The purpose of this study is to understand how personalized risk factors for rheumatoid~     arthritis (RA) may impact willingness to change behaviors associated with RA. The~     investigators have developed a personalized risk estimator for RA based on demographics,~     family history, biomarkers and behaviors related to RA risk. Eligible participants have a~     first degree relative with RA but do not have RA themselves. Participants who meet~     eligibility and consent to the study will be randomized to receive either standard~     information about RA, the online personalized RA risk tool, or the online personalized RA~     risk tool with guidance from a health educator. Participants will be followed to measure~     willingness to change RA risk behaviors. The investigators hypothesize that participants who~     receive the online personalized RA risk tool and health education will be more willing to~     change RA risk behaviors compared to participants that receive standard RA information.~   "
77296|NCT02045615|"~     The purpose of this study is to make clear how difficult it is to remove osteosynthesis~     materials afterwards, so surgeons will think twice before inserting intramedullary nails.~     Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis~     has become.~   "
77267|NCT02045992|"~     Heart failure patients represent a group of individuals at higher risk for cardiac~     arrhythmias. There is a perception that caffeine consumption may represent an increase in~     this risk. Although the medical staff and health professionals suggest a reduction in the~     intake of this substance to patients considered at risk, there is no scientific proof for~     this recommendation.~      Some animal studies suggest a possible association between arrhythmias and caffeine use with~     higher doses, but this finding did not appear in human studies. In particular, little is~     known about the association between caffeine consumption and arrhythmias in patients with~     heart failure, especially at higher doses of consumption.~      More specific and safe guidelines on caffeine consumption are needed.~   "
77268|NCT02045979|"~     Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish~     pharmacokinetic similarity of BI 695501 to adalimumab.~   "
77269|NCT02045966|"~     The primary purpose of this study is to assess the effect of the~     Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the~     pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the~     effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3~     direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325~     75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter~     probe substrates.~   "
77270|NCT02045953|"~     The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging~     Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of~     this exploratory study is to investigate whether the systemic exposure for fluticasone~     propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the~     systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer~     for both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four~     study periods in the study and all participants will receive four study treatments during~     the study. The total duration of study including screening, treatment period, washout~     period, and follow-up period will be 58 days. Study is planned to enroll 20 healthy~     subjects.~      VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark~     of GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.~   "
77271|NCT02045940|"~     This study is the first administration of GSK2881078 to humans. The intention of this study~     is to provide sufficient confidence in the safety of the molecule to inform progression to~     further repeat dose and proof of concept studies. This study will include approximately 52~     subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess~     the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of~     GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5)~     will include three cohorts of 12 healthy male subjects to examine the safety, tolerability,~     PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total~     duration of the study including screening and follow-up, is not expected to exceed 70 days.~   "
77272|NCT02045927|"~     This study looks to assess whether monitoring sedation status in mechanically-ventilated~     Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS)~     monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS)~     score is associated with decreased duration of mechanical ventilation.~      Investigators hypothesize that using BIS monitors to help monitor depth of sedation in~     mechanically ventilated ICU patient will result in a decreased duration of mechanical~     ventilation when compared to solely utilizing clinical sedation scales such as RASS.~   "
77273|NCT02045914|"~     The aim of this study is to evaluate calcium ionophore solution on fertilization rate of~     patients during intracytoplasmic sperm injection who have poor ovarian reserve~   "
77274|NCT02045901|"~     The primary objective of this study is to compare the efficacy of Diclegis for the treatment~     of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with~     placebo.~      The secondary objective of this study is to compare the safety of Diclegis in pregnant~     adolescents aged 12 to 17 years with placebo by assessing differences in the severity and~     occurrence of maternal adverse events (AEs).~   "
77275|NCT02045888|"~     To evaluate the safety and feasibility of adipose-derived regenerative cells injected into~     tears of the hamstring muscle.~   "
77276|NCT02045875|"~     40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20,~     will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3~     months. These intervention subjects will receive medication use feedback at each visit,~     while the control group will receive the standard of asthma care. Those interventional~     subjects with Dulera adherence<60% will receive feedback based on an asthma adherence~     disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will~     been trained in Motivational Interviewing to reduce subject ambivalence about medication~     use. The primary hypothesis is that subjects who receive medication monitoring and~     Motivational Interviewing adherence strategies will have better asthma control, as measured~     by the Asthma Control Questionnaire, than the control group.~   "
77277|NCT02045862|"~     The purpose of this study is to examine how well the combination of two medicines~     (solifenacin succinate and mirabegron) work compared to each medicine alone in the treatment~     of bladder problems, and how safe they are for long term use.~   "
77278|NCT02045849|"~     This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this~     study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet~     formulation compared to the reference capsule formulation under fasted conditions. The~     effect of food on the pharmacokinetics (PK) of a single dose of the tablet formulation will~     also be assessed. Part 2 will evaluate the effect of repeat doses of itraconazole on the~     pharmacokinetics of GSK2140944 following a single dose. A decision will be made whether to~     use the current capsule formulation or the new tablet formulation in Part 2 based upon the~     safety and PK data obtained from Part 1. Part 3 is conditionally based upon progression of~     the tablet formulation from Part 1 and will evaluate the effect of food on the safety,~     tolerability, and pharmacokinetics of the tablet formulation following multiple doses in~     elderly healthy subjects.~   "
77279|NCT02045836|"~     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the~     GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with~     Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on~     Pneumovax 23™ vaccine immune response will also be evaluated.~   "
77284|NCT02045771|"~     The study's primary goal is to assess the effectiveness of behavioural activation in~     reducing depressive symptoms and re-integrate patients with depression into their personal~     and professional lives thus improving quality of life and helping in attaining and~     maintaining remission of depression. It is aimed at helping patients re-engage with several~     life areas that they may have lost in the course of depressive illness. The intervention is~     centred on behavioural activation (BA) with complementary interventions including recreation~     activities, and behavioural modifications. The study question is: in patients with~     depressive disorder attending a specialized hospital based mood disorders clinic, does the~     addition of behavioural activation program delivered in a group format improve depressive~     symptoms and quality of life compared to treatment as usual after 18 weeks of treatment?~     Study investigators hypothesize that behavioural activation is an effective treatment for~     depressive disorder in patients with depression.~   "
77285|NCT02045758|"~     This study will compare blood collection from the forearm using an investigational device~     TAP20-C to blood collection from the fingertip.~   "
77286|NCT02045745|"~     The purpose of this study is to analyze the safety and feasibility of the implantation of~     autologous mesenchymal stem cells (MSCs) expanded in vitro and administered directly in~     the lung line of suture as a treatment for patients at risk of postoperative air leaks after~     lung resection.~   "
77287|NCT02045732|"~     PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an~     antibody that binds to and inhibits the human interleukin-7 receptor, a component~     potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down~     the progression of the disease.~   "
77288|NCT02045719|"~     Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory~     and antitumor properties. Patients and methods: This prospective phase II study will assess~     the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on~     individuals with advanced solid tumors, with no further therapeutic options and with at~     least 2 months life expectancy. In addition, several biochemical and inflammatory parameters~     will be analyzed.~   "
77289|NCT02045706|"~     There are many trials measuring the impact of service work on volunteers themselves, but few~     studies measuring the impact of service on the local people. The purpose of this trial is to~     determine whether US and Ugandan health volunteers can make a measurable impact on the~     health of rural Ugandan villagers.~   "
77290|NCT02045693|"~     The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed~     dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in~     subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with~     the stable dose of Buprenorphine.~   "
77291|NCT02045680|"~     The use of laparoscopic surgery is continuing to increase in colorectal resection and~     expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally~     invasive surgery can lead to faster recovery it can also put significant stresses on the~     patient's heart and cause fluctuations in blood pressure due to the extreme headdown~     positioning and abdominal insufflation of carbon dioxide gas.~      We have performed several surgical cases under deep neuromuscular block and this has allowed~     surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less~     strain on the heart and allowed higher cardiac outputs.~      This study will look at whether deep neuromuscular block is beneficial for patients by~        1. Increasing oxygen delivery, measured using oesophageal doppler monitoring of~          cardiovascular variables intraoperatively~        2. Allowing surgery at lower abdominal insufflation pressures if they have a deep block~        3. Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours~   "
77292|NCT02045667|"~     The main objective of this study is to explore whether multiple trials with individual~     patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on~     clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case~     study, we will study the clinical and cost-effectiveness of Mexiletine in patients with~     Non-Dystrophic myotonia. The results of this analysis will be compared with the results~     obtained from a recently published international, multi-centre, randomized,~     placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia~     (clinicaltrials.gov Identifier: NCT00832000).~      The secondary objective of this proposal is to assess whether mexiletine improves myotonia~     measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.~   "
77293|NCT02045654|"~     To assess the efficacy of decitabine and identify predictors for response to decitabine~     therapy.~   "
77294|NCT02045641|"~     One of the most common postoperative complications after open cardiac surgery is fluid~     accumulation between the pleural membranes or in the pericardial sac. This study~     investigates the consequence of such fluid accumulations on physical performance,~     recovery-time, cardiac and respiratory complications, and quality of life. Half of the~     participants will be followed closely and offered fluid drainage at a low threshold, and~     half of the participants will follow the current postoperative regimen.~   "
77295|NCT02045628|"~     Although obesity surgery is currently the most effective method for achieving weight loss,~     not all patients lose the desired amount of weight and some show weight regain. Previous~     pilot work by the lead researcher shows that successful weight loss is associated with the~     amount of investment the patient feels that they have made in their operation. For example,~     those who feel that it has taken more time and effort to organise, has cost more money, has~     been more disruptive to their family, social and work lives and has caused pain are more~     likely to lose weight after their operation. Therefore, it seems as if the greater the sense~     of investment, the greater the motivation to make the operation a success. The present study~     aims to build on these findings by encouraging weight loss surgery patients to focus on the~     investment they have made, thus making their investment more salient to them. Using a trial~     design, half the patients will be asked to rate and describe the investment they have made~     in their operation just before surgery (focusing on the time and effort to organise the~     surgery etc) and 3 months after surgery (focusing on time off work for recovery, disruption~     of family and friends, pain of surgery, pain of having the stitches removed etc). All~     patients will record their weight, beliefs about food, intentions to change their behaviour~     and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The~     impact of the investment based intervention will then be assessed to explore whether~     focusing on the investment involved in having surgery improves patient health outcomes by~     one year.~   "
77299|NCT02045576|"~     SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are~     position dependent, defined as having an AHI, which is at least twice as high in supine~     sleeping position compared to the AHI during sleep in other positions. Standard therapy for~     patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT).~     Recently a new device Sleep Position Trainer (SPT) is been introduced especially for~     patients with POSA.~      Objective: To compare the effect of positional therapy with the SPT versus OAT on~     polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible~     learning effect that might occur with POSA patients using the SPT for positional therapy~     over a long term.~      Study design: Randomised controlled trial Study population: The participants of the research~     will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint~     Lucas Andreas Hospital, Amsterdam, the Netherlands.~      Participants will be males or females older than 18 years with diagnosis of positional OSA.~      Intervention: The SPT is a sensor positioned in an elastic band attached around the body.~     The SPT measures the body position and vibrates when the patient lies in supine position.~     Oral appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a~     protrusive position. Because of this position more pharyngeal space will be available and~     the AHI will decrease. After randomisation the first group (n=45) will sleep for a period of~     90 +/- 2 days with the SPT every night. The second group (n=45) will also sleep for a period~     of 90 +/- 2 days only with OAT. After this period the PSG is repeated. Long- term outcome in~     AHI is measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary~     endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of~     sleeping supine sleep position, without disturbance of the sleep quality.~      Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ.~      Compliance and learning effect will also be evaluated for the time period of 3 and 12~     months. Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck~     circumference will be assessed.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks for patients participating in this study are negligible.~     Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties~     with an increased sleeping period on the side or difficulties sleeping with the SPT. This~     can be compensated by the expected improvement of sleep quality caused by the therapy.~     Possible side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a~     dry mouth. Withdrawing from this therapy means immediate relief of inconveniences.~   "
77300|NCT02045563|"~     -  Our research hypothesis is to show that a certain number of genetic polymorphisms of~          the proteins involved in glucose, lipid and adipocyte metabolism are factors that~          favour the development of steatosis in patients with Type 2 diabetes.~        -  We also wish to evaluate more thoroughly lipid anomalies associated with the presence~          of steatosis, notably with regard to monocyte expression of LDL receptors. We~          hypothesize that hepatic steatosis is accompanied by activation of transcription~          factors involved in lipogenesis, notably SREBP factors. The activation of these factors~          could cause an increase in the expression of LDL receptors, leading to increased LDL~          catabolism.~        -  Chronological description of the study During an outpatient consultation at the~          endocrinology department, diabetic patients, programmed to undergo an examination to~          assess their diabetes will be invited to participate in the study. Once written~          informed consent has been provided and clinical data has been recorded, patients with~          type 1 or type 2 diabetes will have standard biological examination, which is~          systematically done in such patients (Fasting glycemia, HBA1c, aspartate~          aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL,~          bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol,~          triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).~      As well as the systematic biological tests, 3 additional tubes will be taken to screen for~     genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1,~     Apolipoprotein A - II).~      IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to~     look for the presence of liver steatosis and to measure carotid intima-media thickness.~   "
77301|NCT02045550|"~     To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy~     leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the~     duration of the bronchitis episodes, on the severity and the additional drug demand. A~     prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.~   "
77302|NCT02045537|"~     Study to determine the incidence of Bone Fractures in HIV infected patients in Spain~   "
77303|NCT02045524|"~     The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205~     injection at 10 mg dose administered by intramuscular injection using various injection~     techniques in healthy male and female volunteers after a single dose administration.~   "
77304|NCT02045511|"~     The primary purpose of the study is to develop and test the preliminary efficacy of a~     first-in-kind community-based intervention to provide affordable, accessible and effective~     hearing health care to low-income, minority older adults.~   "
77305|NCT02045498|"~     Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest~     patients in both groups with and without capnography feedback~   "
77306|NCT02045485|"~     Background:~      Several reports have demonstrated an association between psoriasis and cardiovascular~     diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers~     used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess~     homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.~      Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient~     psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG~     and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis~     Area and Severity Index (PASI).~   "
77307|NCT02045472|"~     The purpose of this study is to assess the safety, tolerability, immunogenicity and~     pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.~   "
77308|NCT02045459|"~     For part of this study, we are collecting information from patients that have been~     experiencing the symptoms mentioned above. We are taking this information and creating a~     chest pain registry to follow trends and compare different patients having similar symptoms.~     We hope to gain insight into the quality of life, symptoms, and cardiac events of those who~     are having similar symptoms. The type of information we will collect includes: demographics,~     quality of life, levels of anxiety related to angina pain and cardiac events occurring~     within a 2 year period of time.~      In addition, we are performing a cardiac stress MRI for research purposes to look at the~     blood flow in the small vessels in your heart. During the stress cardiac MRI, we will give~     you a medication called Regadenoson (Lexiscan) which stresses your heart by dilating the~     blood vessels to your heart. This drug is approved by the U.S. Food and Drug Administration~     (FDA) for this purpose. We will then be able to measure the myocardial perfusion reserve~     (MPR) which is a measure of blood flow through the small blood vessels to see if an abnormal~     MPR and small blood vessel disease is associated with an increased risk of cardiovascular~     events, such as heart attack. At this point, there is no specific therapy for small vessel~     disease. In addition we have phase II of this study which is to determine if exercise and~     intensive medical therapy together compared to intensive medical therapy alone improves pain~     from the heart and improves overall quality of life.~   "
77309|NCT02045446|"~     The core hypothesis to be tested is that the use of consolidative SBRT followed by~     maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary~     + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy~     alone.~   "
77311|NCT02045420|"~     The purpose of this study is to use non-invasive Magnetic Resonance Imaging (MRI) scans to~     investigate venous insufficiency, brain iron levels and white matter hyperintensities (WMHs)~     to determine if there is direct correlation with Idiopathic Parkinson's Disease (IPD).~      Idiopathic Parkinson's disease (IPD) is the second most common neurodegenerative disease~     after Alzheimer's disease and it affects roughly 0.1% to 0.3% of the population. The risk of~     having IPD increases with age and the median onset age is about 60 years. The etiology of~     IPD remains unknown. Generally, Parkinson's patients show a reduction of dopamine levels in~     the deep grey matter of the brain over time. Many clinically diagnosed cases of IPD are~     associated with white matter hyperintensities (WMH) and elevated brain iron levels.~     Furthermore, in the last few years there has been an increasing interest in the role of~     veins in neurodegenerative diseases. More attention has been paid to the extracranial veins~     as being potential sources of venous hypertension. The obstructed veins are thought to cause~     venous insufficiency. By using MRI techniques, the investigators can not only obtain~     qualitative vascular information but also quantitative arterial and venous blood flow~     measurements.~   "
77312|NCT02045407|"~     The purpose of this study is to assess the reliability of computed tomography angiography~     (CTA) to diagnose brain death, face of several conditions that make impossible to define~     such diagnosis using clinical criteria exclusively.~   "
77313|NCT02045394|"~     Haemoptysis is the coughing up of blood originating from the respiratory tract. It is a~     common and worrying clinical symptom which can be due to different aetiologies including~     lung cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown~     origin (cryptogenic haemoptysis). Epidemiology and optimal diagnostic approach are largely~     unclear. Aims of this study are to define current epidemiology and to provide the best~     diagnostic approach by providing a diagnostic algorithm.~   "
77314|NCT02045381|"~     Currently, appropriate patients undergo MRI imaging with immobilization and sequences~     optimized for diagnostic radiology purposes. Using a mutual information algorithm, these~     images are then registered to a treatment planning CT obtained with custom immobilization to~     minimize intra-and inter-treatment motion and positional variation. This image registration~     process is time-consuming and introduces additional layers of geometric uncertainty into~     what should be a highly precise treatment planning process. However, it is necessary, since~     radiation dose calculations cannot be performed on MRI data due to the lack of crucial~     density information. The investigator envisions CT-less treatment planning, using only MRI,~     due to superior imaging characteristics, fully integrated into the radiation oncology~     clinic. This study will begin this process.~   "
77315|NCT02045368|"~     This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in~     patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV~     infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until~     disease progression, unacceptable toxicity, or patient refusal. Assessment of response will~     be confirmed with imaging studies performed at the end of cycle 2, and every 2 weeks after.~   "
77316|NCT02045355|"~     Health effects of fish consumption have been demonstrated in epidemiological studies and in~     controlled intervention studies in a number of different population groups, however,~     randomized controlled studies on the effect of fish consumption in elderly are sparse. Many~     studies have focused on n-3 fatty acids instead of fish as a food and therefore, many health~     effects have only been related to the effect of n- 3 fatty acids. The elderly are a~     heterogeneous population group and therefore difficult to study. In order to reduce~     heterogeneity, it is advisable to focus on elderly with specific needs. Elderly who~     experienced a hip fracture can serve as a model for an advanced ageing process, as these~     patients typically experience a huge inflammatory response, immobilisation and a reduction~     in muscle mass. Increased fish intake is believed to have effects towards inflammation and a~     reduction in muscle mass. Therefore, we want to test whether increased fish intake can have~     positive health effects in elderly who experienced a hip fracture.~      Main hypothesis:~      Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase~     mobility, muscle strength and mobility in frail elderly.~      Objectives~        1. To evaluate the health effects of fish consumption in frail elderly The effect of a~          dietary intervention with fish on mobility, muscle mass and strength in elderly who~          experienced a hip fracture has not been shown before.~        2. To demonstrate the feasibility of dietary intervention in elderly We want to show that~          a dietary intervention with fish or control meals is feasible in elderly. The meals (4~          portions of fish per week or control portions of meat) will be delivered to their~          homes.~      Description of work and role of participants This is a randomized clinical trial (RCT) on~     the effect of fish consumption on mobility in elderly who experienced a hip fracture.~     Elderly who experienced a hip fracture but were able to walk without support by a person~     before the fracture, will receive, after being randomized to two groups, fish or meat to be~     used in cold or warm meals at 4 days per week for a period of 16 weeks. Measurements will be~     taken at baseline (when patients have left the rehabilitation center), after 4 weeks and~     after 16 weeks. Measurements at 4 and 16 weeks after inclusion will be at their homes or in~     the outpatient clinic.~   "
77317|NCT02045342|"~     This study will investigate the effects of hydrothermally modified starch (SuperStarch) in~     adults. SuperStarch, originally developed as a drink for children with glycogen storage~     disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended~     periods. Therefore, it could be beneficial to exercise and mental performance, and could~     possibly have fat loss effects by increasing feelings of fullness. In this study, measures~     will be taken in 25 men to assess mental function, appetite, and metabolism to determine the~     processes involved in possible fat loss.~   "
77318|NCT02045329|"~     The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may~     serve as a host defense mechanism against colonization and infection by Staphylococcus~     aureus, including methicillin resistant S. aureus (MRSA). Mupirocin is a topical~     antibacterial agent that may be used to clear nasal colonization with S. aureus, and reduce~     risk of S. aureus infection. The impact of mupirocin on the normal nasal microbiome is not~     known. We hypothesize that the nasal microbiome is changed by mupirocin. Our study aims to~     define the nasal microbiome before and after decolonization therapy with mupirocin.~   "
77319|NCT02045316|"~     The etiologic agent responsible for the development of preeclampsia remains unknown.~     Aquaporins, members of integral membrane proteins, are responsible of water molecules~     movements through the plasma membrane channels, energy metabolism and associated with~     changes in cellular volume during apoptosis.~      İn such placental pathology as preeclampsia, characterized with superficial implantation and~     increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis~     of aquaporins important role in energy homeostasis and apoptosis maybe suggested.~   "
77320|NCT02045303|"~     Wound healing rate is higher when contact ultrasound therapy is followed by noncontact~     ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies~     requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.~   "
77964|NCT02036905|"~     The objective of this pilot study is to determine the feasibility of a large-scale trial.~     The primary objective is to determine if manipulation applied to the cervical and thoracic~     spines is more effective than mobilization applied to the cervical and thoracic spines for~     the management of patients with mechanical neck pain.~   "
77321|NCT02045290|"~     Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a~     sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1~     Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will~     improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic~     euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20~     year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c~     7.0%-9.9%).~   "
77322|NCT02045277|"~     The objective of the study is to evaluate the safety and efficacy of a topical lotion~   "
77323|NCT02045264|"~     This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of~     icatibant administered to adult Japanese subjects.~   "
77324|NCT02045251|"~     Over the years, it has become clear that the first-line triple therapy is losing efficacy~     worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg~     bismuth subcitrate potassium, and 125mg tetracycline was made available.~      The efficacy of the Pylera capsule was studied in a randomized control trial, in which a~     quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard~     triple regimen. In the study, 3 three-in-one capsules were taken four times daily (after~     meals and at bedtime).~      Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera~     capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole~     twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.~   "
77325|NCT02045238|"~     Acute viral bronchiolitis is an extremely common childhood disease, responsible for~     approximately 17% of childhood admissions to hospital per year, with an annually cost that~     reaches U$ 500 million.~      Despite being a well known disease among pediatricians, there are few, if any, effective~     treatment options apart from oxygen supplementation and adequate hydration.~      The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more~     effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of~     in-hospital treatment.~   "
77326|NCT02045225|"~     Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency~     Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM~     (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in~     Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV~     prevalence rates among MSM in North American cities, there is a critical need for HIV~     prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated~     in interpersonal situations, is a reliable risk factor for unprotected anal intercourse~     (UAI) among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural~     therapy, a form of psychotherapy (6). Social anxiety may also increase substance use in~     sexual situations, which is another risk factor for HIV among MSM (7 and 8). As such, an~     empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM.~     The present study will provide Phase I trial data for a novel and innovative HIV prevention~     intervention for MSM. This is a proposal to test a novel integrated HIV prevention~     intervention that combines empirically supported treatments for social anxiety with HIV risk~     reduction counseling to reduce HIV sexual risk behaviour.~   "
77327|NCT02045212|"~     The study objectives are to assess any changes in visual acuity and visual field observed~     following the administration of RPh201 during an overall treatment period of at least 13~     consecutive weeks with an option to extended the treatment phase to another 13 weeks (26~     weeks total), and at the follow-up visit at 3 month after end of treatment in patients with~     optic nerve neuropathy.~   "
77328|NCT02045199|"~     The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in~     the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.~   "
77329|NCT02045186|"~     The purpose of this research study is to determine whether and when patients with human~     papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and~     chemotherapy clear their human papilloma virus infection.~   "
77330|NCT02045173|"~     The purpose of the study is to compare, three months after implantable~     cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D),~     the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with~     similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable~     impedance-based respiration sensor (AHIAS).~   "
77331|NCT02045160|"~     In this study, we aim to investigate the incidence of the adverse reactions, the~     effectiveness and the gene polymorphism associated with the plasma level of~     sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole,~     sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate~     the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.~   "
77332|NCT02045147|"~     There is overwhelming evidence that patients with multiple chronic illnesses need better~     self-management skills. Discharge from the hospital may not be the most opportune time to be~     teaching patients these self-management skills. There are several different care transition~     models being used across the country; however we know that not every patient needs the same~     type or amount of an intervention. The purpose of this pilot study is to examine the effects~     of delivering a home based care transitions intervention (HBCTI) with four different groups~     tailored on cognition and level of patient activation compared to usual care (UC) on the~     outcomes of health care utilization (HCU) and health outcomes: patient-reported health~     status, assessment of care for chronic conditions, and quality of life in adult patients~     with multiple chronic diseases dismissed to home from an acute care facility. Our working~     hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU~     and improved outcomes (patient-reported health status, assessment of care for chronic~     conditions, and quality of life).~   "
77383|NCT02044484|"~     This research, co-sponsored by the Centers for Disease Control and Prevention and the~     National Institute of Mental health, is conducted at six HIV clinics in the U.S. The~     research examines the effect of a clinic-based multi-component intervention delivered to HIV~     patients when they attend clinic for primary care. The study tests the hypothesis that the~     intervention will improve the viral load status of patients and improve attendance for HIV~     primary care.~   "
77333|NCT02045134|"~     Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after~     a cardiac surgery. Both systemic inflammation and oxidative stress play a role in the~     initiation of POAF after a cardiac surgery. Epidemiological studies show a significant~     inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods~     (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic~     components. The main objective of this study is to evaluate the effect of polyphenol-rich~     food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an~     open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or~     repaired (VR))~   "
77334|NCT02045121|"~     Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about~     300,000 patients annually (UK and USA). Lung and breast cancers account for majority of~     malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of~     patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling~     and impairs quality of life. Median survival ranges between 4-6 months. Although~     thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the~     standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy,~     and talc is the most effective agent. For successful pleurodesis to occur the underlying~     lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up~     to 30%. Symptomatic patients require hospitalization for these procedures which are likely~     to fail if trapped lungs are encountered, and pose significant burden to health services.~     Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which~     provides access to the pleural space for fluid drainage when breathlessness arise. IPC can~     be performed at ambulatory setting without hospital admission. Case series have demonstrated~     long-term safety of IPC even in patients undergoing chemotherapy with acceptable~     complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous~     pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for~     trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc~     pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads~     to reduction in hospitalizations, adverse events and healthcare costs, and if it improves~     quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc~     pleurodesis, and endpoints include hospitalization days till death or end of study, adverse~     events, quality of life, and healthcare costs.~   "
77335|NCT02045108|"~     The overarching goal of this study is to determine whether combined cognitive training and~     Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To~     this end, specific study purposes are: 1) replicate previous findings that cognitive~     retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced~     with tDCS, and 3) investigate the neural changes that result from cognitive retraining and~     tDCS. We hypothesize that those participants who receive alcohol avoidance cognitive~     training will have greater reductions in drinking. In turn, those participants who receive a~     higher level of applied tDCS during alcohol avoidance response training will have better~     avoidance learning, as well as, a larger reduction in drinking behavior. Finally, those~     participants receiving a higher level of applied tDCS will have more neuronal response~     associated with alcohol avoidance during the brain imaging session.~   "
77336|NCT02045095|"~     This is an open-label, multicenter, phase 1, dose escalation study with expansion cohorts~     that will evaluate the safety (establish the MTD and inform the RP2D), tolerability, PK,~     pharmacodynamics, and antitumor activity of MLN7243 in patients with advanced malignant~     solid tumors.~   "
77337|NCT02045082|"~     The purpose of this study is to compare a corneal sampling realized by a flocked swab~     (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab~     164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes~     simplex epithelial keratitis will be the primary objective of this study.~   "
77338|NCT02045069|"~     This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and~     Safety of Ivermectin in Children and Adult patients with Dengue Infection.~   "
77339|NCT02045056|"~     The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating~     microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact~     cognition and mild cognitive impairment~   "
77340|NCT02045043|"~     Arrhythmias remain a major health problem, causing at least 250,000 deaths annually in the~     United States. Pharmacological treatments often do more harm than good, and device therapies~     are limited by high cost and effects on quality of life. Ion channel mutations cause rare~     inherited arrhythmopathies, but account for only a small fraction of patients with life-~     threatening arrhythmias and sudden death. Most arrhythmias occur during myocardial ischemia,~     following myocardial infarction, and in patients with poor left ventricular (LV) function of~     any etiology. Aside from ejection fraction (EF), few clinically useful indicators to~     stratify the risk of sudden death have been identified. The role of subtle difference in ion~     channel expression and/or structure in predisposing patients to arrhythmias and modulating~     the risk of sudden death is unknown.~      In this study, we are prospectively testing whether polymorphisms in ion channels and ion~     channel modifying genes are associated with arrhythmias in a population with internal~     cardioverter-defibrillators (ICDs) and poor LV function. We will test the hypothesis that~     functional polymorphisms in the coding sequences and promoter regions of cardiac genes (e.g.~     ion channels, beta-adrenergic receptors) predispose individuals to arrhythmias and /or heart~     failure progression.~      We hope to identify genetic predictors for the common forms of sudden cardiac death. This~     would allow the identification of a subpopulation of heart failure patients that would~     benefit most from ICD placement.~   "
77341|NCT02045030|"~     This is a Phase II multi-center exploratory study to identify biomarkers predictive of~     clinical response to aflibercept in patients with metastatic colorectal cancer who have~     failed first-line therapy, consisting of an oxaliplatin-containing regimen in combination~     with bevacizumab. Patients will consent to a needle core biopsy of a liver metastatic lesion~     prior to starting treatment and blood samples will be collected from study patients during~     treatment.~      An exploratory pharmacoeconomic analysis will be performed to evaluate productivity loss,~     quality of life and resource utilization while on treatment with aflibercept.~   "
77342|NCT02045017|"~     The primary purpose of the study is to determine the safety and efficacy and to generate PK~     and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in~     patients with relapsed or refractory multiple myeloma, with moderate or severe renal~     impairment.~   "
77415|NCT02044068|"~     Vertical HIV transmission has been dramatically reduced by the use of combined~     antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs,~     several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir.~     Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in~     developed countries. The study hypothesis is a major reduction of the risk of HBV vertical~     transmission.~   "
77343|NCT02045004|"~     Despite an ongoing controversy in the scientific literature, the link between anesthesia and~     dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an~     association of surgery with a reduction in brain volume. With the present prospective cohort~     study, we would like to reproduce and verify these results, and investigate a possible~     association with the postoperative cognitive performance.~      We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months~     after major non-cardiac surgery and determine cognitive functions at the same time.~      Study hypothesis:~        1. Surgery under general anesthesia in elderly patients is associated with a loss of gray~          matter.~        2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain~          areas relevant for cognitive functions.~   "
77344|NCT02044991|"~     The purpose of this study is to see if pelvic girdle pain can be more effectively treated~     with the use of injectable anti-inflammatory medication plus physical therapy compared with~     physical therapy and a saline injection.~   "
77345|NCT02044978|"~     16 patients will be included. Each patient receives 2 dental implants. One of them is coated~     with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance~     frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in~     each patient are compared. We expect to find an early improvement (higher resonance~     frequency) in the coated implant.~   "
77346|NCT02044965|"~     Although clean intermittent catheterization (CIC) remains the mainstay to ensure complete~     low-pressure bladder emptying in neurogenic bladder (NB) patients, this forms a vehicle for~     bacterial entry and colonization of the urinary tract, which can lead to recurrent urinary~     tract infection (RUTI) and renal damage. Up to 25% of NB patients on CIC suffer from RUTI~     and daily, low-dose antibiotic prophylaxis is widely prescribed to prevent these infections.~     Unfortunately, this therapeutic option is not evidence-based and can be associated with a~     higher risk of RUTI secondary to development of antibiotic resistance. In addition, many~     children suffer from a range of adverse reactions and emergence of drug resistant organisms.~     Moreover, recent studies have shown that antibiotics cause a major disruption in the human~     microbiome, potentially leading to long term major problems.~      Probiotics are live microorganisms, which when administered in adequate amounts confer a~     health benefit on the host. There is evidence that probiotics restore microbial homeostasis~     in the vagina, reduce the risk of pathogen ascension into the bladder, and modulate immunity~     to better protect the host. Probiotic strains, including Lactobacillus rhamnosus GR-1,~     Lactobacillus reuteri B-54 and RC-14, have been shown to be safe and efficacious in an oral~     formulation or as a vaginal suppository in improving the microbiota profile of the vagina~     and decreasing the risk of RUTI. Various mechanisms appear to be involved, including~     modulating antimicrobial and inflammatory defenses, up-regulating protective mucin~     production and reducing the pressure on pathogens to acquire antibiotic resistance genes. A~     randomized trial comparing probiotics to antibiotic prophylaxis in children with~     vesicoureteric reflux showed equivalent reduction in the incidence of RUTI and development~     of new renal scarring. In addition, down regulation of inflammatory cytokines can~     potentially favorably alter bladder function and prevent bladder fibrosis.~      Investigators at London Health Sciences Centre (LHSC) have the opportunity to acquire~     clinical data that would strengthen the case for probiotics to be integrated into pediatric~     urology practice for managing CIC and RUTI. This would be the first such study in pediatric~     NB patients.~      The main objective of this study is to determine whether the use of probiotics~     (lactobacilli) can decrease the impact of adverse side effects and the antibiotic resistance~     that is seen with the prolonged use of antibiotics for patients with neurogenic bladder~     conditions.~   "
77347|NCT02044952|"~     The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in~     the treatment of Crohn's disease for induction remission and compare the therapeutic effect~     with patients who received mesalazine.~   "
77348|NCT02044939|"~     The primary objective of the study is to assess the improvement of daily activity in~     subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary~     rehabilitation program.~      The secondary objectives are the following:~        -  assess the improvement of daily activity at several times : 2, 6 and 12 months after~          the beginning of a pulmonary rehabilitation program~        -  assess the improvement of exercise capacity by tests used in medical practice~        -  assess the correlation between daily activity and exercise capacity~        -  assess the improvement of dyspnea~        -  assess the improvement of quality of life and psychological state~   "
77349|NCT02044926|"~     Purpose:~      To investigate diagnostic performance of CT and MR in intraductal papillary mucinous~     neoplasm with malignant change according to international consensus guidelines 2012.~      Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main~     pancreatic duct size of larger than 10 mm will be significant.~   "
77350|NCT02044913|"~     The primary objective of this study is to test in a randomized controlled trial if~     aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare~     approach in the treatment of depression and anxiety.~   "
77351|NCT02044900|"~     The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes~     for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes~     evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation~     index) and heart rate variability (HRV) indexes.~   "
77352|NCT02044887|"~     Objective: To assess the effectiveness of an intervention in Primary Health Care to increase~     the physical activity (PA) and improve cognitive state and cardiovascular risk in patients~     with dementia and their relative caregivers.~      The results can be used to improve the technical characteristics of the devices that record~     the physical activity of patients with dementia make marketing easier~   "
77353|NCT02044874|"~     In smokers who are motivated to stop smoking, treatment with lorcaserin compared with~     placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks~     9-12)~   "
77354|NCT02044861|"~     ACT-PFK-158 is a novel anti-cancer agent that inhibits glucose uptake in cancer cells. The~     primary objective of the study will be to determine the maximum tolerated dose (MTD) and to~     describe any dose limiting toxicity. The secondary objectives of the study will be to~     determine the safety profile of the drug, to determine the pharmacokinetic profile, to~     identify any anti-tumor activity, and to determine the pharmacodynamic profile of~     ACT-PFK-158.~   "
77355|NCT02044848|"~     This study will assess the safety and efficacy of secukinumab on the preservation of~     pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.~   "
77416|NCT02044055|"~     HBV can be transmitted from mother-to-child, with a risk increasing according to maternal~     HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication.~     Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about~     vertical HDV transmission are old, justifying a new study.~   "
77417|NCT02044042|"~     Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to~     10%). Spontaneous viral clearance in infected children during childhood can occur, but data~     about this phenomenon are scarse, justifying the study.~   "
77356|NCT02044835|"~     • Background: Since evidence show that renal-artery stenting did not confer a significant~     benefit with respect to the prevention of clinical events when added to comprehensive,~     multifactorial medical therapy in people with atherosclerotic renal-artery stenosis[1], the~     aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine,~     combined with optimal medical therapy of internal medicine (OMT), including anti-platelet~     therapy and other protocol-driven medical therapies to control blood pressure and glucose~     and lipid levels in accordance with guidelines,resulted in greater renal function protection~     in patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.~      Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients~     with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3~     will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo~     Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for~     different groups, meanwhile, all participants in both treatment groups received OMT, 6~     months therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR),~     urine protein, and cardiovascular and renal events (a composite end point of death from~     cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for~     congestive heart failure, progressive renal insufficiency, or the need for renal-replacement~     therapy) will be compared between the Groups as the outcome.~   "
77357|NCT02044822|"~     This study will evaluate the effect of treatment with idelalisib (IDELA) plus rituximab on~     overall response rate (ORR); onset, magnitude, and duration of disease control (including~     duration of response [DOR], progression free survival [PFS], and overall survival [OS]); and~     minimal residual disease (MRD) in subjects with previously untreated chronic lymphocytic~     leukemia (CLL) with 17p deletion. In addition, the study will evaluate the safety profile~     observed with the combination of IDELA and rituximab.~   "
77358|NCT02044809|"~     The purpose of this trial is to investigate a novel treatment for cannabis dependence:~     cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for~     moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims~     to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use~     over four treatment weeks. Stage two will determine whether the MED identified in stage 1~     can offer an effective treatment for cannabis dependence.~   "
77359|NCT02044796|"~     This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride~     when given together with filgrastim, cladribine, and cytarabine and to see how well they~     work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes~     that is newly diagnosed, has returned, or does not respond to treatment. Drugs used in~     chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading.~   "
77360|NCT02044783|"~     Sedentary older adults are more likely to develop physical function impairments than active~     older adults. Physical function measured by slow usual gait speed predicts the risk of~     future falls, disability, institutionalization and mortality. Behavioral physical activity~     interventions have improved physical activity and physical function, but have not generally~     been implemented where they may have the most impact -- primary care settings. In part, this~     is due to the limited time and training for clinical staff to screen for physical function~     impairment and to treat with physical activity counseling. The proposed scientific goal is~     to overcome these barriers by adapting an evidence-based screening tool and telephone-based~     physical activity intervention into primary care settings.~      Aim1: Among older adults who screen positive for physical function impairment, to determine~     the estimated intervention effect size of a 12-week behavioral intervention on physical~     activity and physical function.~      Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual~     care group.~      Hypothesis 1b: Physical function will increase more in the intervention vs. usual care~     group.~      Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and~     Aim 1 intervention, to evaluate standard implementation science process metrics of reach,~     acceptability, and implementation~   "
77361|NCT02044770|"~     The primary objective of this clinical study is to describe the initial clinical experience~     with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or~     qualifying how its articulation feature enables optimization of vessel sealing through~     improved access, approach, and visibility. This is an observational study of device usage~     being conducted to report initial experience with the ENSEAL ART device. It is not intended~     as hypothesis testing.~   "
77362|NCT02044757|"~     The purpose of this study to investigate the addictive properties of soda and other sugar~     sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that~     participants who were regularly consuming sweetened and caffeinated beverages will~     experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the~     SSB withdrawal period.~   "
77363|NCT02044744|"~     The purpose of this study is to determine the impact of primary care referrals to community~     physical activity programs for overweight and obese youth aged 6-18 years on objectively~     measured physical activity and cardiorespiratory fitness, as well as other cardiovascular~     health indicators. We hypothesize that physical activity referrals will result in higher~     levels of physical activity and fitness.~   "
77364|NCT02044731|"~     The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session~     childhood obesity intervention for African American families among children aged 5-12 years.~     We hypothesize that children participating in the program will experience a reduction in~     BMI.~   "
77365|NCT02044718|"~     An adverse event (AE) is defined as unintended injury or complication, which results in~     disability, death or prolongation of hospital stay, and is caused by healthcare management~     (including omissions) rather than the patient's disease. Retrospective record reviews in~     several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience~     one or more AEs. A patient with an AE may require a higher level of care. Although all AEs~     are important, preventable AEs that result in an upgraded level of patient care are of~     particular concern. In this study it's defined as an unplanned admission to intensive care~     unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are~     to determine the incidence of (preventable) adverse events requiring ICU admission or MET~     intervention and to assess the level of harm of each AE.~   "
77373|NCT02044614|"~     1. To assess the feasibility and safety of applying a 12-week course of adjuvant~          low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of~          thrice-weekly in-center hemodialysis.~           Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented~          in the context of ongoing thrice-weekly in-center hemodialysis.~        2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based~          peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on:~          inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water,~          ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in~          serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning,~          energy fatigue, and general health scores.~      Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will:~        1. reduce inter-hemodialytic weight gain*~        2. enable achievement of lower hemodialytic dry weight~        3. reduce total body water~        4. improve ambulatory blood pressure control~        5. reduce serum phosphorus~        6. minimize per-hemodialytic changes in serum potassium and pH~        7. have favorable effects on indices of physical function and global health~             -  Indicates co-primary outcomes.~   "
77374|NCT02044601|"~     The goal of the Phase I part of this clinical research study is to find the highest~     tolerable dose of onartuzumab that can be given with erlotinib and standard chemoradiation~     (paclitaxel and carboplatin) to patients with NSCLC.~      The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help~     to control NSCLC. The safety of this drug will also be studied.~   "
77375|NCT02044588|"~     To determine the safety of using kidney organ from hepatitis B surface antigen positive~     donor, the author conducted the single-center, prospective study of the use of these kidneys~     for recipients who have protective level of hepatitis B surface antibodies.~   "
77376|NCT02044575|"~     Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over~     the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based~     sepsis therapy bundles) the mortality of septic shock remains high and causes high~     socioeconomical burden of disease.~      The purpose of this pilot study is to evaluate the design and conduct of a projected full~     scale clinical trial.~   "
77377|NCT02044562|"~     The purpose of this study is to evaluate whether dietary nitrate supplementation could~     improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent~     chemo-radiation therapy.~   "
77378|NCT02044549|"~     to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of~     Postpartum hemorrhage after cesarean section~   "
77379|NCT02044536|"~     The optimal number of biopsy and the detection rate of neoplastic lesions are not~     established. The aim of this study is to assess the current practice pattern and effect of~     training in upper endoscopic biopsy.~   "
77380|NCT02044523|"~     Liver fibrosis is an important public health problem, with a substantial morbidity and~     mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of~     chronic liver disease may lead to fibrosis. The traditional diagnostic approach requires a~     biopsy for assessing the severity of liver disease prior to therapy.~      However, liver biopsy has several limitations: cost, sampling error, and procedure-related~     morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic~     fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is~     an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic~     liver disease severity.~      Our team has the expertise to investigate ultrasound-based and magnetic resonance-based~     elastographic methods for the noninvasive staging of liver fibrosis.~      The primary objective of this cross-sectional study is to compare the sensitivity of~     elastographic methods for detecting histology-determined significant fibrosis.~      The secondary objectives are to compare the diagnostic accuracy of these elastographic~     methods and the influence of potential confounders (inflammation, steatosis and iron~     deposition) on their diagnostic accuracy.~   "
77381|NCT02044510|"~     The proposed study is a randomized, double blind placebo controlled multicenter study to~     determine the effectiveness of mirabegron in the treatment of neurogenic bladder~     dysfunction. Patients will be randomized into one of two trial arms: mirabegron 25mg for two~     weeks, with escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two~     weeks, with placebo escalation for the remaining 8 weeks. Each of these trial arms will be~     stratified based on whether the patient is already taking an anticholinergic medication or~     not. The study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The~     study hypothesis is that mirabegron will result in a statistically superior (increased)~     urodynamic bladder capacity.~      The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo~     treatment will be administered. The primary outcome measure will be based on an increase in~     urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic~     parameters, urinary symptom scales, urinary quality of life indices, and voiding diary~     results.~      Patients who are over 18 years of age with a diagnosis of multiple sclerosis or spinal cord~     injury will be eligible to participate. All eligible patients will have urodynamic studies~     performed within 4 weeks of trial enrollment, and at the end of study (week 9-10). Adverse~     events and study outcomes will be assessed at predefined study time points.~   "
77382|NCT02044497|"~     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of~     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely~     used in adults and children to relieve post-operative pain. However, its pharmacokinetics~     (what it does in the body) and pharmacodynamics (how it works) have not been well~     established in children. Some children, because of their specific genetic make-up, may~     metabolize the drug more quickly and therefore may be at risk for more side effects in the~     commonly prescribed dose. We would like to find out more about how this drug is absorbed,~     metabolized and excreted in children. In order to study these aspects, we would like to give~     oxycodone to surgical patients at Boston Children's Hospital then measure its metabolic~     activity and also perform a genetic analysis. The genetic testing is specifically to analyze~     the following genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4),~     which represent the differences in cytochrome P450 metabolism of oxycodone.~   "
83096|NCT01969799|"~     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin~     inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in~     mechanically ventilated patients receiving IV antibiotics.~   "
77384|NCT02044471|"~     Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the~     treatment of end-stage heart failure, affording patients significantly improved quantity and~     quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide,~     with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD~     therapy, one major weakness is the high frequency of late strokes, reported up to 19%. CF~     LVADs minimize or remove the pulsatility within the blood system, introducing a new and~     incompletely understood physiology.~      Increased sympathetic (fight or flight nervous system) tone secondary to lack of pulse in~     the blood system can cause high blood pressure, with subsequent hemorrhaging strokes~     (bleeding into the brain) are one possible explanation for this high adverse event rate in~     CF LVAD patients. A simple intervention to decrease the increased sympathetic tone is called~     ischemic conditioning; a sphygmomanometer (blood pressure cuff) is placed on the patient's~     arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion)~     for set periods of time. This has been shown to reduce blood pressure and major adverse~     cardiovascular events in other patient populations.~      We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients~     with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes~     in this patient population.~   "
77385|NCT02044458|"~     Study Design:~      Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary~     Purpose: Treatment~      Detailed Description~      The utilization of a Foley catheter for induction of labor is well established. There are~     two techniques readily used for placing a Foley catheter. The most common method is under~     direct visualization of the cervix during a sterile speculum examination and the other~     method is to place a catheter during a digital cervical examination.~      Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to~     maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The~     Foley catheter plus rigid stylette technique seems to be an efficient and safe method for~     labor induction. However, to our knowledge there is no study that assesses the difference~     between the standard digital placement of a Foley catheter versus the digital placement of a~     Foley catheter with stylette.~   "
77386|NCT02044445|"~     During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is~     administered to trigger the final follicular maturation before oocyte retrieval, in an~     attempt to mimic the physiologic effects of LH. The hCG is administered when more than three~     follicles ≥17mm in mean diameter have developed.~      The time interval between hCG administration and oocyte retrieval is of critical importance~     since the time after luteinizing stimulus is a period of intense processes including the~     start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.~      The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to~     avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown~     that significantly more high quality embryos have been obtained with a prolonged~     hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be~     beneficial in improving oocyte quality and achieving optimal maturation.~      Currently there are no data on the effect of the time interval between hCG administration~     and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to~     determine whether there is any difference in in vitro fertilization outcome when oocyte~     retrieval takes place at 36 h or 38 h following hCG administration~   "
77387|NCT02044432|"~     The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at~     least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at~     least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to~     the respective control group (waitlist).~   "
77388|NCT02044419|"~     To compare the relative bioavailability of lomitapide when administered by sprinkling the~     contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral~     intact capsule dose of 20 mg lomitapide in healthy subjects.~   "
77389|NCT02044406|"~     To investigate the safety, tolerability, pharmacokinetics (including dose proportionality~     assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising~     dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus~     the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI~     1181181 (Bioavailability/Food effect (BA/FE) part)~   "
77390|NCT02044393|"~     Investigation of the relative bioavailability of a single dose of BI 691751 when given alone~     and together with itraconazole; safety and tolerability~   "
77391|NCT02044380|"~     The main aim of this study is to evaluate the safety and tolerability of afatinib in~     patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring~     Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an~     EGFR-Tyrosine Kinase Inhibitor (TKI)~   "
77392|NCT02044367|"~     To investigate the relative bioavailability of dabigatran etexilate as pellets on food and~     of dabigatran etexilate as granules resolved in reconstitution solution, each with~     dabigatran etexilate as capsule following oral administration. To evaluate acceptability and~     palatability of Pellets sprinkled on food and Oral Liquid Formulation~   "
77404|NCT02044211|"~     Depression is highly prevalent among patients with heart failure (HF) and associated with~     lower levels of health-related quality of life and physical functioning, and higher risk of~     rehospitalization and mortality, and higher health costs. This Project will compare the~     effectiveness of a blended telephone-delivered collaborative care intervention for~     treating both HF and depression to: (1) collaborative care for HF-alone (enhanced usual~     care; eUC); and (2) doctors' usual care for depression (UC). If proven effective and~     cost-effective, the potentially more powerful, scalable, efficient blended care approach~     for treating HF and co-morbid depression could have profound implications for improving~     chronic illness care and stimulate development of blended interventions for treating other~     clusters of related medical conditions.~   "
77511|NCT02042820|"~     In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry~     eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an~     in vivo metric to measure inflammatory changes in the central cornea. The objective of the~     current study is to assess inflammatory response changes in the peripheral cornea and the~     conjunctiva by analyzing epithelial immune cell density and morphology in these areas and~     then correlating the IVCM findings to clinical signs and symptoms to establish novel~     objective imaging biomarkers.~   "
77393|NCT02044354|"~     Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as~     second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has~     demonstrated a survival benefit versus mitoxantrone in patients progressing during or after~     Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have~     different toxicity profiles.~      Many patients who are receiving Jevtana for second-line treatment indicate they prefer this~     agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy,~     nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was~     associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than~     Taxotere in first-line setting.~      The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the~     patient preference between two standard treatments for first-line metastatic kidney cancer.~     Despite similar PFS improvements over placebo in phase III trials, results clearly showed~     that patients preferred pazopanib over sunitinib.~      A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in~     first-line setting with overall survival as a primary end-point. Assessing patient~     preference between Jevtana and Taxotere would contribute to further identify differences~     between these two taxanes and clarify which one of these two taxanes should be used for~     second-line chemotherapy and perhaps for first-line chemotherapy in the future.~      Assessing patient preference between the two taxanes might be less biased in the first-line~     setting where patients have no previous experience with a taxane.~   "
77394|NCT02044341|"~     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear~     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The~     patient or caregiver will measure the amount of ear pain before and after the ear drops to~     establish if the medicated ear drops decrease the amount of pain more than the placebo ear~     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can~     be used up to 4 days, as needed for ear pain.~   "
77395|NCT02044328|"~     Adjuvant therapy has been proved effective in treating earlier stage or less advanced~     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as~     adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The~     primary endpoint is disease-free survival.~   "
77396|NCT02044315|"~     The aim of the present study is to investigate whether increasing detection zones can~     effectively reduce inappropriate ICD therapies in primary prevention patients.~   "
77397|NCT02044302|"~     The investigators hypothesize that in mastectomy patients with breast reconstruction, the~     addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the~     acute and chronic setting, compared to traditional pain management techniques which rely~     almost exclusively on opioid analgesics and sedatives like diazepam (valium). This~     expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will~     produce muscle relaxation, the combination of which will target different sites of pain~     generation, thus producing better analgesia. We also hypothesize that additional benefits~     may accrue from this regimen including decreased nausea and vomiting, sedation and~     constipation as a result of diminished opioid use1.~   "
77398|NCT02044289|"~     The purpose of this study is to (a) measure how brain structure, metabolism (how the brain~     uses energy), and function predict response to electroconvulsive therapy (ECT) for treatment~     of depression; and (b) measure how ECT changes brain metabolism and function. We will ask~     you to undergo magnetic resonance imaging (MRI) at three sessions: (1) prior to your first~     ECT therapy session, (2) after having 4-6 ECT therapy sessions, and (3) approximately two~     months following your first ECT therapy sessions.~   "
77399|NCT02044276|"~     The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to~     pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.~   "
77400|NCT02044263|"~     Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior~     Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a~     negligible number of patients with insomnia receive this treatment. One potential way of~     improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new~     method for delivering CBT-I and it is not known how effective online treatment is compared~     to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online~     CBT-I. Because of the great advantage of online treatment in both availability and cost, the~     trial is designed as a noninferiority trial.~      Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with~     CBT-I as delivered face-to-face by a therapist.~   "
77401|NCT02044250|"~     Objectives :~      To compare the efficacy and safety of clopidogrel monotherapy with aspirin monotherapy in~     patients who received dual or triple antiplatelet therapy for 1 year (± 6 months) after~     drug-eluting stent implantation for coronary artery disease~      Patient Enrollment :~      5530 patients enrolled at 55 centers in Korea~      Patient Follow-up :~      Clinical follow-up will occur at 1, 12 and 24 months.~      Primary Endpoint :~      Composite endpoint of MACE and major bleeding~      Secondary Endpoint :~      Device-oriented composite outcome including TLR (target lesion revascularization), TVR~     (target vessel revascularization), stent thrombosis, and minor GI (gastrointestinal)~     complications~   "
77402|NCT02044237|"~     Online study for patients with trichotillomania. 4 main hypothesis.~        1. Alexithymia and Trichotillomania correlated and regression analyses find association~          between them~        2. we will be able to find patient who have never been treated before. Those will suffer~          to the same amount as previously treated patients~        3. Decoupling will be more helpful than progressive muscle relaxation~        4. different constructs of emotion regulation will show different trait and state~          characteristics in patients with trichotillomania~   "
77403|NCT02044224|"~     The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE~     procedures for solid tumours~   "
77414|NCT02044081|"~     The focus of the study is to evaluate the safety of multiple study drug administrations and~     the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will~     compare a liquid and gel product applied in different modes.~   "
77512|NCT02042807|"~     To evaluate the effect of MCS® compared with placebo in reducing the risk of~     biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of~     treatment.~   "
77405|NCT02044198|"~     The purpose of this study is to evaluate an experimental malaria vaccine for its ability to~     prevent malaria infection or disease in a blood-stage challenge model (when volunteers are~     infected with malaria parasites using malaria-infected red blood cells). The vaccine being~     testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve~     the body's response to a vaccination) called AS01B.~      The aim is to use this protein and adjuvant to help the body make an immune response against~     parts of the malaria parasite. This study will enable assessment of:~        1. The ability of the vaccine to prevent malaria infection.~        2. The safety of the vaccine in healthy participants.~        3. The response of the human immune system to the vaccine.~      This will be done by giving participants three vaccinations and then exposing them to~     malaria infection by transfusing a small number of red blood cells infected with malaria~     under carefully regulated conditions. Participants will be followed closely to observe if~     and when they develop malaria. If the vaccine provides some protection against malaria,~     participants will take longer to develop malaria than usual or will not develop malaria at~     all.~      The study will enrol 15 participants to be vaccinated and then challenged with malaria in~     addition to recruit 15 individuals to be control subjects.~   "
77406|NCT02044185|"~     Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell~     transplantation is one of the meaningful issues in aspect of patient's recovery and~     survival. in recent years, the understanding of the pathology of GVHD is much important to~     prevent or treat aGVHD. additionally, (oral) mucositis is one of the problems in patients~     with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as~     proinflamtory cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if~     it was released to the outside of cells by damaged cell or necrotic tissues, it works as~     cytokines for promoter of inflammation and cancers. at this point, there are no reported~     articles about correlation of HMGB1 and aGVHD in human. recently, we have seen excessive~     secretion of serum HMGB1 in mouse model, then base on this results, we will check~     correlation of HMGB1 and aGVHD/ oral mucositis in human.~   "
77407|NCT02044172|"~     RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy~     uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor~     may not need treatment until it progresses. In this case, active surveillance may be~     sufficient. It is not yet known which treatment regimen is more effective for localized~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying active monitoring to see how well it~     works compared with radical prostatectomy or radiation therapy in treating patients with~     localized prostate cancer.~   "
77408|NCT02044159|"~     Approximately 20,000 children per year in North America present to the hospital with severe~     shock. Children who develop this condition have very low blood pressures and as a result may~     suffer damage to their internal organs and may even die. Some children with this condition~     may significantly benefit from the use of steroids but steroids in such patients may also~     have potential side effects. Therefore it is important to study the use of steroids~     carefully in these children. The STRIPES research program will examine the effectiveness and~     safety of steroids in children. Before conducting a large, randomized controlled trial~     (RCT), a pilot study (STRIPES Pilot Study) will be conducted in multiple sites across~     Canada. The STRIPES Pilot Study will allow testing of the STRIPES study protocol in a~     smaller group of patients.~   "
77409|NCT02044146|"~     In patients with heart attacks, the treatment of choice is to restore blood flow with~     percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).~     After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications~     block full function of the platelet cells, which are responsible for clotting. Despite their~     use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A~     major contributor may be resistance to clopidogrel. New more potent drugs, which can~     overcome the resistance, are now available; however, they come with an increase chance of~     severe bleeding and costs. An ideal solution would be to identify at-risk patients and~     selectively treat them with more potent drugs, while lower-risk patients continue with~     clopidogrel. This type of strategy (personalized strategy) would decrease heart attacks and~     death (compared to clopidogrel), while also preventing bleeding complications (compared to~     treating all patients with the new drugs).~      Of resistant patients, many carry genes (inherited units) that prevent proper absorption of~     clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies~     carriers of at-risk genes. However, this technique alone does not identify all at-risk~     patients. Consequently, we have now devised a novel tool, which combines genetics with~     patient characteristics to identify high-risk patients.~      The present study combines this new tool into a strategy for personalized treatment.~     Patients with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies:~     a) new personalized strategy, b) clopidogrel strategy (previous standard drug) or c)~     ticagrelor strategy (stronger approved drug). The function of the platelet cells will be~     measured at 1 month to determine potential benefits. Evaluation of this new personalized~     strategy is important for improving patient outcomes after PCI. The hypothesis is that~     patients receiving a personalized strategy will have decrease risk for future heart attacks~     and bleeding.~   "
77410|NCT02044133|"~     The study will be proposed to man entering the prison of La Roche sur Yon. Participants will~     be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6~     months after the entry and the second arm will carry only a dosage six months after entry.~      the purpose of the study is to determine the interest of dosage of vitamin D in biological~     assessment of entry into prison house.~   "
77411|NCT02044120|"~     The purpose of this study is to define the dose-limiting toxicities and maximum tolerated~     dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of~     temozolomide in patients with pre-treated incurable Ewing sarcoma.~   "
77412|NCT02044107|"~     This project applies a randomized community design to test the effectiveness of health~     center level co-packaging and counseling messages to improve provider and caregiver behavior~     in the treatment of diarrhea with zinc & oral rehydration salts (ORS) and treatment of~     pneumonia with zinc & antibiotics in children aged 2-59 mo old. We will evaluate the~     adherence of caregivers in 10 health posts in 5 municipalities randomly assigned to receive~     the health center level co-packaging and counseling messages in addition to current standard~     care, by comparing them with the caregivers in 10 health posts in 5 municipalities randomly~     assigned to the receive only the current standard of care. Cost-effectiveness of~     co-packaging at the health-center level, as a means of improving provider treatment and~     counseling practices and caregiver adherence, will be evaluated.~      The main objective is to establish the effectiveness of a facility level co-packaging and~     counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old~     to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea~     and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated~     in public health posts.~      Specific Quantitative Objectives:~      • To determine if visible co-packaging with pre-tested counseling messages:~        -  Improves adherence of caregivers of children towards the prescribed zinc treatment.~        -  Improves knowledge, awareness or attitudes of caregivers of children and health~          providers at public health care centers towards the prescribed zinc treatment.~        -  Results in overall increase in health care-seeking for the treatment of diarrhea and~          pneumonia at public health care centers.~      Specific Qualitative Objectives:~        -  To establish the perception, attitudes and experiences of caregivers towards the~          visible co-packaging with pre-tested counseling messages to promote the prescribed zinc~          treatment.~        -  To establish the perception, attitudes and experiences of health providers at public~          health care centers towards the visible co-packaging with pre-tested counseling~          messages to promote the prescribed zinc treatment.~        -  To establish the perception, attitudes and experiences of children aged 4 to 5 years~          old towards the visible co-packaging with pre-tested counseling messages to promote the~          prescribed zinc treatment.~   "
77413|NCT02044094|"~     This is a multiple-dose study in non-treatment seeking male and female subjects with~     moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical~     Manual of Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to~     block exogenous opioids.~   "
77418|NCT02044029|"~     This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular~     atrophy (SMA) patients and in age- and gender-matched healthy volunteers will assess the~     detection of disease progression by magnetic resonance imaging (MRI) and the Muscle Function~     Measure (MFM) test.~      Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at~     Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally~     undergo testing of motor function and have blood samples taken for Survival of the Motor~     Neuron (SMN) genes, proteins and mRNA analysis.~   "
77419|NCT02044016|"~     The purpose of this study is 1) to develop and validate a new measurement to assess the~     length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of~     the ankle joint is a better method.~   "
77420|NCT02044003|"~     The study is intended to evaluate the safety and feasibility of using the Intact Vascular~     (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System)~     in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.~   "
77421|NCT02043990|"~     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the~     machine applies positive pressure throughout inspiration in proportion to the electrical~     activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test~     the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV~     delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants~     with Acute Respiratory Failure.~   "
77422|NCT02043977|"~     Insomnia is a widespread condition in which approximately one-third of adults in the United~     States are symptomatic with 6% of the population meeting the diagnostic criteria for~     insomnia. There is an increased risk of insomnia in certain segments of the population~     including women, middle-aged and older adults, shift workers and individuals with medical or~     psychiatric disorders. Individuals with insomnia have a decreased quality of life compared~     to those who report other serious illnesses such as major depression and congestive heart~     failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric~     disorders, medical and neurologic disorders. It can impair cognitive and physical~     functioning.~      Propofol is an approved drug administered intravenously for use in the induction and~     maintenance of anesthesia or sedation. Some research suggests that propofol when~     administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease~     of awakening and the integrity of behavior following waking.~      This study will be conducted in the Broward Health Medical Center Sleep Lab, under the~     direct care of a Board Certified Anesthesiologist, dedicated to the study involving~     participants who have refractory chronic primary insomnia and have not responded to~     conventional pharmacologic therapies within the past 90 days. Each qualifying participant~     will receive an IV infusion of the study medication for 5 consecutive nights. Assessments~     including polysomnography with completion of questionnaires will occur at screening, Days 1~     through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will~     also be distributed on Day 180.~   "
77423|NCT02043964|"~     This is a multicentric and prospective study for the validation of a diagnostic method in~     multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that~     can be recognized in order to help in the diagnosis of this pathology and that could~     possibly replace the lumbar punction which is an invasive method. Semi-automatic and~     automatic techniques of isoelectric focusing will be developed for analyzing data from~     tears. These results will help in the identification of markers of this disease.~   "
77424|NCT02043951|"~     The registry will enroll patients with claudication or critical limb ischemia and~     angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be~     treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to~     the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.~   "
77425|NCT02043938|"~     Background of the study:~      Multiple electroencephalographically derived indices have been developed to measure the~     cerebral hypnotic drug effect during anesthesia, using a variety of mathematical algorithms~     such as bispectral index, spectral entropy and spectral edge frequency. The complexity of~     the raw EEG is reduced to -an easy to interpret- number. It varies generally between 100~     (fully awake patient) to 0 (an excessively sedated patient).~      The anesthesiologist adjusts his dosing scheme to target a number between a predefined~     range. (e.g. between 40 and 60) These monitors are currently solidly integreted in clinical~     practice although they keep being hampered by several limitations. The most important~     problem is that they are not extracted from a direct neuro-physiological phenomenon that is~     known to be closely related to loss and return of consciousness, rather they have a~     probabilistic nature, indicating whether your probability of responsivenessis is high or~     low.~      You are never sure which EEG phenomenon relates to the index. Also, the number that relates~     to loss of consciousness rarely is the same as the number that indicates return of~     consciousness, which decreases the predictive value during recovery of anesthesia.~     Additionally, the dose response relationship differs on multiple parameters between each~     monitors. As such the performance of one monitor cannot be extrapolated to another. Finally,~     although the detection capacity of responses to verbal command is fairly good, EEG extracted~     numbers perform worse on correlation with movement after a noxious stimulus. Most problems~     are related to the limited understanding of the relationship between the changes in EEG and~     the underlying (insufficiently understood) neurophysiological mechanism that evokes~     (un)consciousness during anesthesia. Secondly, at the time of development of most monitors,~     the methods of drug administration were less reproducible to allow a more rational drug~     titration in a population of different demographics. The last two decades, major progress~     has been made on both issues. Therefore, new insights in neuro-physiology and better drug~     titration systems opens new perspectives to improve EEG derived data extraction.~      Recently, Mashuire et al found a typical EEG characteristic that is correlated consistently~     with the loss and return of responsiveness, independent of the anesthetic used (inhalation~     or intravenous) and independent of the species tested (rats and humans). These findings do~     suggest that new information can be extracted from the raw EEG that has a much closer~     connection with the essential neurophysiological processes involved to evoke~     consciousness/unconsciousness or responsiveness/unresponsiveness. In this study we want to~     collect data that allows us to recognize these patterns on the EEG as a better measurement~     of consciousness/unconsciousness.~      Additionally, we have the ability to use (clinically availlable) target controlled infusion~     techniques for propofol (plasma- and/or effect-site controlled) and end-tidal titrated~     sevoflurane (through a Zeus Ventilator (Draeger)) If we titrate our hypnotics through these~     more advanced and pharmacologically more rational titration methods, we may detect a more~     relevant correlation between the dose given and the EEG behavior. By adding remifentanil, we~     will also explore the alteration of performance of EEG derived information during~     interaction with opioids. The obtained data may result in a breakthrough in the methodology~     to titrate anesthesia in a more predictable and reproducible way, because the extracted~     information relates closer to a neuro-physiological process related to (un)responsiveness.~     Moreover, the index may produce more consistent results whether inhaled anesthetics or~     intravenous drugs are given.~   "
77426|NCT02043925|"~     Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a~     QT-prolonging drug is added to a medication profile that already contains a potential~     QT-prolonging drug. An ECG is taken before the administration of the new drug and a week~     after starting the new drug to investigate the change in duration of the QTc-interval. Risk~     factors for developing QT-prolongation and blood concentrations of potassium and creatinine~     are documented.~   "
77427|NCT02043912|"~     In this epidemiological point prevalence study, medication profiles of patients with~     haloperidol treatment will be checked for drug interactions with risk of QT-prolongation.~     Additional clinical risk factors for developing QT-prolongation and safety measurements will~     be documented.~   "
77428|NCT02043899|"~     This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer~     (called [124I]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood~     cancer) compared to the recommended 1-dimensional routine scans (called [123I]mIBG planar~     scintigraphy).~   "
77429|NCT02043886|"~     Postprandial hypotension carries a risk of significant morbidity and morbidity including~     syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy~     consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of~     which are suboptimal and poorly studied.~      The study hypothesis is that administration of Acarbose will decrease the drop in blood~     pressure and increase in heart rate in response to food in people with Type 2 diabetes.~      Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and~     delaying gastric emptying.~      This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the~     meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one~     meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo.~     Order of treatment assignment will be done in randomized fashion. A total of approximately~     200 cc of blood will be drawn during each meal test.~   "
77462|NCT02043457|"~     The Investigational Weight Management Clinic at the University of Michigan was created to~     identify strategies that will result in cost-effective, long term weight management for~     overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size~     fits all' philosophy is untenable with a complex disease such as obesity. The clinic will~     serve as a portal for patients to choose standard clinical care or to explore alternatives~     from a variety of clinical studies offered through the clinic. These studies will include~     further investigations into nutrition, the biological basis of weight and weight management~     and protocols using approved and experimental pharmaceuticals.~   "
77430|NCT02043873|"~     Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess~     the longevity of repairs to localized clinical defects in composite restorations that were~     initially scheduled to be treated with a restoration replacement Methods: 28 patients aged~     18 to 80 years with 50 composite restorations were recruited.Restorations with clinically~     diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were~     randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the~     restorations was scored according to the modified USPHS criteria. A Wilcoxon test was~     performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized~     for multiple comparisons between different years of the same group.~   "
77431|NCT02043860|"~     In this phase I trial, patients with multiple myeloma will receive standard high dose~     melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will~     include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will~     increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients~     enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.~   "
77432|NCT02043847|"~     In this phase I trial, patients with relapsed or refractory multiple myeloma will receive~     standard high dose melphalan with autologous stem cell rescue. In addition the~     pre-transplant conditioning will include targeted total marrow irradiation (TMI). This~     conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated~     dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of~     3Gy. Maximum dose will be 9Gy.~   "
77433|NCT02043834|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and~     gait) in older adults.~      We hypothesize that the virtual reality-based balance training intervention will improve~     balance and gait performances in older adults compared to a control group receiving usual~     care only.~   "
77434|NCT02043821|"~     Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy~     are candidates for an convenient maintenance treatment.~   "
77435|NCT02043808|"~     The objective is to assess the safety and effectiveness of new dabigatran and warfarin~     patients diagnosed with NVAF in the US DoD population.~   "
77436|NCT02043795|"~     The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable~     Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects~     with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of~     the tibial arteries.~   "
77437|NCT02043782|"~     The aim of the investigation was to investigate the performance and safety of a new ostomy~     product~   "
77438|NCT02043769|"~     The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and~     children in South Africa to examine, clinical, immunologic, virologic, metabolic,~     psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive~     de-identiﬁed records review of all HIV-infected children enrolled in at the pediatric~     Wellness and ART clinics at the ﬁve study sites; and (2) a prospective cohort surveillance~     study with active consented enrollment with 12-24 months of follow-up. As part of the~     prospective cohort, the study will aim to collect outcomes on children lost to follow-up,~     including causes of death through review of death certiﬁcates in the clinical chart and~     through verbal autopsy reports. The study will provide insights into overall outcomes for~     the larger pediatric patient populations in the province and South Africa. This work is~     designed in collaboration with the provincial health authorities of the Eastern Cape~     Department of Health (EC), The International Center for acquired immune deficiency syndrome~     (AIDS) Care and Treatment Programs (ICAP) South Africa and Center of Disease Control~     (CDC)-South Africa in support of the South African National ART Program for Children and~     aims to collect and analyze accurate, relevant and useful information that will be available~     on children seen at facilities. For the prospective cohort study, we will aim to enroll 400~     children newly initiated on ART at 5 health facilities in the Eastern Cape of South Africa~     who will be actively followed for up to 24 months.~   "
77439|NCT02043756|"~     The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD),~     and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.~   "
77440|NCT02043743|"~     Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary~     ovarian insufficiency (this is the most accurate term as some women may still conceive),~     premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to~     function adequately in a woman younger than 40 years, in its role either as an endocrine~     organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism,~     and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer~     responding to circulating FSH by producing estrogen and developing fertile eggs) in women~     younger than 40 years. This condition occurs in approximately 1% of women and it has~     important physical and psychological consequences/impact in those patients.~      The purpose of this study is to investigate the role of the transplantation of bone marrow~     derived stem cells into ovarian tissue for treatment of premature ovarian failure and to~     assess their ability to differentiate into germ cells.~   "
77441|NCT02043730|"~     Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment~     approaches to locally advanced pancreatic cancer management.~      Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic~     cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a~     progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting~     activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and~     gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.~   "
77442|NCT02043717|"~     The investigators study is designed to test the hypothesis that correction of vitamin D in~     CF patients can increase their lung function and decrease the number of their pulmonary~     exacerbations.~   "
77463|NCT02043444|"~     Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm~     cells by positive testicular extraction and those with a negative extraction.~   "
77521|NCT02042690|"~     The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to~     improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell~     transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in~     first phase of complete remission (CR1)~   "
77443|NCT02043704|"~     This randomized controlled trial will evaluate the effects of perioperative intravenous (IV)~     acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing~     vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive~     either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive~     1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control~     group will receive placebo saline infusions at the same time intervals. All subjects will~     receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS)~     regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to~     discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects~     receiving IV acetaminophen will have lower VAS scores and decreased total narcotic~     consumption in comparison to the control group.~   "
77444|NCT02043691|"~     This is a single-center study to evaluate the safety and effectiveness of three~     investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular~     Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving~     the visceral vessels.~      The three investigational devices offer an endovascular approach to treat complex aortic~     pathologies that cannot be treated with commercially available devices. This customized,~     endovascular approach has the potential to decrease hospital length of stay, pulmonary~     complications, and in-hospital mortality.~   "
77445|NCT02043678|"~     To determine if the addition of radium-223 dichloride to standard treatment is able to~     prolong life and to delay events specific for prostate cancer which has spread to the bone,~     such as painful fractures or bone pain which needs to be treated with an X-ray machine.~   "
77446|NCT02043665|"~     The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in~     combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while~     sparing normal cells) and to establish a safe multi-dose schedule of the virus for the~     treatment of solid tumors where enhanced expression of ICAM-1 and/ or DAF receptor occurs.~      This trial will consist of 2 sequential parts: VLA-009 (Part A) conducted only in the UK~     employs CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and~     bladder cancer. VLA-009 (Part B) conducted in the US and UK employs CVA21 with pembrolizumab~     in NSCLC and bladder cancer.~      Both VLA-009A and VLA-009B are open-label, multi-center, ascending dose escalation (3+3~     design) dose-finding and signal-seeking studies.~   "
77447|NCT02043652|"~     Background: The World Health Organization recommends that antimalarial treatment policies be~     evaluated every few years to check their efficacy. P. vivax malaria is the most common~     species in Brazil and cases are concentrated in the Amazon Region in Brazil.~      Objectives: Assess the efficacy of chloroquine and primaquine for the treatment of P. vivax~     infections in Cruzeiro do Sul, Acre, Brazil.~      Methods: An in vivo drug efficacy study will be conducted in Cruzeiro do Sul, Acre State,~     Brazil. A total of 117 study participants ≥5 years of age with parasitologically confirmed~     P. vivax monoinfections will be treated under supervision with chloroquine (CQ) for three~     days at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National~     Malaria Control guidelines. For patients with normal glucose 6 phosphate dehydrogenase~     activity levels, investigators will add primaquine at dose of 0.5mg/Kg per day for 7 days.~     Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to~     evaluate drug efficacy and for a total period of 168 days (6 months) to evaluate chances of~     recrudescence, relapse, or reinfection. Blood samples will be taken to measure the CQ levels~     in blood on Day 7 and day of failure, if occurring in the initial 28 days of follow up. In~     addition, a blood sample will be collected on filter paper on first day and on day of~     suspected failure to help differentiate parasite genotypes using techniques based on~     polymerase chain reaction. Results from this drug efficacy study will be used to assist the~     Brazilian Ministry of Health in assessing their national malaria treatment policy for P.~     vivax malaria.~   "
77448|NCT02043639|"~     In this study, the goal is to find out if the clinicCompanion™ is effective in measuring~     range of motion when compared to the goniometer. Currently, the goniometer is an approved~     device to measure range of motion by the FDA, but the clinicCompanion™ is not.~   "
77449|NCT02043626|"~     Our long-term objective is to reduce the rates and risk of childhood obesity via~     school-based nutrition and physical activity policies. Using a randomized design, we propose~     to monitor and evaluate how Connecticut's first-ranked District Wellness Policy, in the New~     Haven Public School district, is implemented and determine its impact on children's~     obesogenic behaviors, weight outcomes, and school performance. This study is designed to~     significantly advance empirical research on school wellness policies and to provide~     important evidence to guide future interventions in schools and communities - translating~     science to improved health of the public.~   "
77450|NCT02043613|"~     The study is designed to investigate the effect of physical surroundings on the effect of~     exercise therapy for knee and hip pain.~   "
77451|NCT02043600|"~     The aim of this randomized trial is to investigate the effects of a 12-week yoga~     intervention compared to self-care on quality of life, stress, psychological health, and~     physiological parameters in 77 patients with ulcerative colitis.~   "
77452|NCT02043587|"~     The objective of this protocol is to improve survival for adults with acute lymphoblastic~     leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system~     (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal~     cytarabine (Depocyt®) CNS prophylaxis.~   "
77453|NCT02043574|"~     Strokes are very common in the United States and occur more in the elderly. The number of~     strokes is likely to double in the next 50 years. Many stroke survivors are sedentary and~     have a poor dietary intake, which results in abnormalities in fuel utilization (eg~     carbohydrate versus fat). This study will examine the effects of dietary modification and~     treadmill training on fuel utilization and physical function. We will study skeletal muscle~     oxidative stress in chronic stroke patients and the ability to employ dietary modification~     and exercise training to reverse these abnormalities in this ethnically diverse population.~   "
77464|NCT02043431|"~     The purpose of this study is to develop a biobank containing samples of 2,000 patients~     treated in a tertiary cardiology hospital containing electronic medical records and genetic~     data in genome-wide scale for performing genetic association studies for validation and~     development of medical decision routines that help the clinical management of heart failure~     patients.~   "
77454|NCT02043561|"~     The aim of this study will be to investigate the effect of rectal distension, controlled by~     electronic barostat, on cognitive control ability in healthy subjects. We will use the~     Stroop task and an intertemporal choice task as standard instruments. Like bladder control~     and rectal control, both Stroop task performance and intertemporal choices - though very~     different tasks at the surface - are dependent on the conflict monitoring function of the~     anterior cingulate cortex. The Stroop task requires the naming of the print color of a~     series of visually presented color words, and reaction time and error rates are typically~     used as performance indicators. When word color and word meaning do not match, performance~     of the task (color naming) requires the inhibition of a (near) automatic response (word~     reading). The intertemporal choice task consists of a series of choices between a sooner~     smaller monetary reward and a larger but later reward. The choices are constructed such that~     they allow the estimation of a discount parameter, which is an index for the level of~     impulsiveness manifested by the participant at the time the choices are made.~      The hypothesis is that the inhibition induced by the urge generated during rectal distension~     will improve cognitive inhibitory performance, as has previously been shown for bladder~     filling.~   "
77455|NCT02043548|"~     The purpose of this multi-center pilot study is to determine if the drug tocilizumab~     (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM)~     and dermatomyositis (DM).~   "
77456|NCT02043535|"~     Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow~     to the muscles of the heart when the heart is at rest and when it is under stress. The~     stress test in MPI can be done using medications, such as adenosine, that dilate coronary~     arteries and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the~     blood, or hypercapnia, also dilates arteries and increases blood flow. Thornhill Research~     Inc. has developed the RespirAct ™ Gen4 sequential gas delivery system used to control CO2~     levels in the blood. The RespirAct ™ Gen4 can deliver precise amounts of CO2 through a~     mouthpiece for inhalation to increase CO2 levels in the blood and thereby increasing blood~     flow like during stress.~      The objective of this study is to compare the differences in blood flow through the arteries~     of the heart during stress with hypercapnia and adenosine MPI. The imaging will be done~     using positron emission tomography (PET) with the radioisotope, or tracer, called Rubidium~     (Rb-82). The Rb-82 is given through a pump, or elution system.~      The investigators hypothesize that hypercapnia will induce a stress-to-rest increase in~     myocardial blood flow by a factor of 2 or more in myocardial regions supplied by~     non-stenotic arteries in normal volunteers and participants with coronary artery disease.~   "
77457|NCT02043522|"~     This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear~     diagnostic imaging test for patients with decreased heart function which can be used to~     predict the progression of the heart disease and provide the appropriate clinical treatment.~     The types of patients to be studied include patients who have had a heart attack where heart~     muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts.~     Both conditions may cause poor muscle contraction and disturbances in electrical signal~     conduction. There will also be a control group of participants with no evidence of heart~     disease.~      123I-mIBG has been shown to be effective in assessing the areas of the heart being activated~     involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based~     radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is~     responsible for the way the SNS regulates heart functions such as heart rate and the force~     of heart contractions. NE acts automatically to maintain a homeostasis or balance within the~     SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the~     heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure,~     arrhythmias (irregular heartbeats) and cardiac death.~      Two different types of single photon emission computed tomography (SPECT) imaging will be~     used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize~     that CZT SPECT will have greater H/M ratios than standard SPECT imaging.~   "
77458|NCT02043509|"~     The overall aim of the study is to estimate the likely impact of the MiQuit text message~     based smoking cessation service for pregnant smokers and to establish robust estimates for~     the key factors which would be required in order to design a larger definitive trial of this~     intervention(MiQuit).~      These key factors include: the range of recruitment rates in different centres; quit rates~     amongst participants; feasibility of assessing smoking status of participants in later~     pregnancy; and the likely effect of MiQuit when women are offered this in National Health~     Service (NHS) settings.~   "
77459|NCT02043496|"~     The purpose of the study is to test a newly developed individual psychotherapy treatment for~     binge eating disorder in adults. This treatment is a type of individual psychotherapy called~     Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their~     behaviors, feelings, thoughts about themselves, and relationships. This new treatment is~     being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help~     (CBTgsh), which focuses on changing behavior patterns through the use of reading and~     homework assignments along with sessions with a therapist. The primary hypothesis of this~     investigation is that ICAT will be associated with greater reductions in binge eating at end~     of treatment and follow-up compared to CBTgsh.~   "
77460|NCT02043483|"~     Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely~     metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no~     molecular markers for this physiopathological connection have been identified.~      This project aims to determine non-invasive biomarkers that may allow better comprehension~     of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive~     airway pressure (CPAP) on these metabolic parameters.~      This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems~     to further explore the mechanisms behind OSAS, as well as the effect of the treatment with~     CPAP.~   "
77461|NCT02043470|"~     The investigators propose using retinal oximetry to assess for abnormalities in regional~     retinal oxygen consumption in previously- irradiated patients, and relate these~     abnormalities to changes in regional retinal function (i.e. visual field abnormalities).~     Since different regions of retina receive different radiation doses, the investigators will~     assess for a dose response as well.~   "
77522|NCT02042677|"~     This evaluation is being conducted to determine user perception of a new flat one-piece skin~     barrier compared to their normal barrier.~   "
77467|NCT02043392|"~     Anastomosis of intestine or other viscera currently requires open or laparoscopic surgery~     and is often the most difficult, time-consuming, and expensive part of many operations. We~     have developed a device (Magnamosis) that may create compression anastomoses more easily,~     quickly, and less expensively than sutures or staples. The Magnamosis device consists of two~     23-mm diameter, convex-concave, radially symmetric ring magnets encased in polycarbonate.~     One magnet is placed in the lumen of each viscus to be joined, the magnets self-align, and a~     compression anastomosis is achieved by tissue remodeling. We have completed extensive~     pre-clinical studies in animals and have shown that Magnamosis can be used to accomplish~     gastrojejunostomy, jejunojejunostomy, duodenal-colostomy, and colo-colostomy safely and~     effectively using available endoscopic and minimally invasive surgery techniques. We are now~     conducting a small first-in-human study to obtain clinical data in support of the safety and~     early feasibility of the Magnamosis device.~   "
77468|NCT02043379|"~     The purpose of this study protocol is to determine if administering Intravenous~     Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced~     hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes~     (i.e., infection, fluid overload, and associated morbidities).~   "
77469|NCT02043366|"~     Purpose:~      To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a~     combination of both received before anesthesia induction.~      To evaluate and examine the incidence of adverse effects with the purpose of selecting the~     optimum dose.~   "
77470|NCT02043353|"~     Sleep-disordered breathing in children is characterized by recurrent events of partial or~     complete upper airway obstruction during sleep, resulting in disruption of normal gas~     exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom~     is snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of~     disorders that includes primary snoring, UARS and OSA. The main etiology for SDB in children~     is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB~     is adenotonsillectomy.~      The objectives of this study are:~        1. To investigate the natural history of primary snoring~        2. To investigate the effect of seasonality on SDB severity~        3. To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in~          children~        4. To characterize the children referred for repeated PSG following adenoidectomy or~          adenotonsillectomy and the indications for second PSG evaluation.~   "
77471|NCT02043340|"~     In recent years, there has been a growing interest in the use of dental lasers for treatment~     of periodontal diseases. Commercially available photodynamic therapy for periodontal~     diseases utilizes methylene blue as a photosensitizer. In this study, the effects of a novel~     photosensitizer dye, indocyanine green (ICG), as an adjunct to nonsurgical treatment of~     chronic periodontitis will be evaluated.~   "
77472|NCT02043327|"~     The aim of this study is to create simulation-based tests with credible pass/fail-standards~     for two different fidelities of colonoscopy models~        1. virtual reality simulator~        2. physical model simulator To create pass/ fail standards for certification~   "
77473|NCT02043314|"~     The recommended treatment for latent tuberculosis infection for adults is a daily dose of~     isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The~     treatment duration and the high pill burden compromised patient adherence to the treatment.~     The Brazilian National Programme for Tuberculosis requested the development of a new 300mg~     isoniazid formulation. The aim of the study is to compare the bioavailability of the~     isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.~      The study is a randomized, single dose, open label, fasting, two-phase crossover~     bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human~     volunteers. For the determination of isoniazid in human plasma, the investigators developed~     and validated a sensitive, simple and rapid HPLC-MS/MS method.~      This will support the strategy adopted by the Brazilian National Program for Tuberculosis~     for the treatment of latent tuberculosis. The new formulation will increase patients'~     adherence to the treatment and quality of life. Medical doctors in Brazil should become~     aware of the new formulation and the new treatment strategy in order to prescribe the right~     medication and avoid errors that could result in a high frequency of adverse events. Future~     research studies should evaluate pharmacovigilance, acceptability of the new tablet~     formulation and its impact on the cure rate.~   "
77474|NCT02043301|"~     This study aims to characterize the single dose pharmacokinetics of PF-04950616 following~     subcutaneous injection to the abdomen, upper arm or the thigh.~   "
77475|NCT02043288|"~     This clinical trial is designed to evaluate the impact of the addition of NC-6004 to~     gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic~     cancer in Asian countires.~   "
77476|NCT02043275|"~     The purpose of this study is to determine if jump landing mechanics in young female athletes~     can be improved with a resistance training intervention.~   "
77477|NCT02043262|"~     The purpose of this study is to determine whether a special kind of rehabilitation offered~     to home-dwelling older adults is effective with regards to functional ability and municipal~     costs.~   "
77478|NCT02043249|"~     In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only~     in the age of 3-5 month after birth the infant start to develop them by himself.~      In preterm infants the starting point of the level of the IgG's is lower from the level of~     term infants.~      Delayed cord clamping /milking it was prooved in many researches as benificial in terms of :~     levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by~     means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing~     entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking~     it will increse the level of IgG's in preterm infants. The end point hypothesis is that~     delayed cord clamping /milking cause to less fever disease or hospitalization it the~     neonats.~   "
77479|NCT02043236|"~     This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health~     in men receiving androgen deprivation therapy (ADT).~   "
77480|NCT02043223|"~     The purpose of this study is to evaluate the effect of post-partum maternal vitamin A~     supplementation on breast milk bioactive compounds and immune status, growth and morbidity~     of children in the first four months of life.~   "
77481|NCT02043210|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This~     program specifically designed for Spanish-speaking substance users to evaluate its~     effectiveness relative to standard outpatient counseling at the Hispanic Clinic. The~     computer-based training program (CBT4CBT) focuses on teaching basic coping skills,~     presenting examples of effective use of coping skills in a number of realistic situations in~     video form, and providing opportunities for patients to practice and review new skills while~     receiving substance use treatment.~   "
77482|NCT02043197|"~     Prospective, multicenter, non-comparative, observational program to describe prevalence of~     depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the~     severity of anxiety and depression, sleep state, and cognitive function.~   "
77483|NCT02043184|"~     Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals~     of this study are to improve adherence to oral chemotherapeutic medications and~     self-management of symptoms among cancer patients. More than 40 oral agents currently are on~     the market with projections that in three years 30% of the cancer treatment agents will be~     delivered in oral form. As a result, patients must assume responsibility for taking~     medications and self-management of associated side effects.~      This longitudinal randomized trial tests and compares 'two strategies' for improving patient~     adherence to their oral cancer medication prescriptions to standard care. Both strategies~     incorporate symptom management support using an interactive voice response system (IVR) for~     symptom assessment and a printed evidence-based Medication Management and Symptom Management~     Toolkit (Toolkit) with helpful strategies and information for symptom management.~      We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this~     study. Recruiters will identify patients as they are prescribed oral cancer medications,~     present the study to the patient, and ask them to consent to be part of the study.~      Study Aims Following are the Aims of the study.~        1. Cancer patients assigned to the intervention will have greater adherence to their~          prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12~          (sustained effect).~        2. When compared with patients receiving weekly assessments only, patients receiving~          weekly assessments plus daily adherence reminders and printed symptom management~          strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will~          be sustained at weeks 5-8, and at 12 weeks.~      Two exploratory aims are assessed:~        1. To test how patient characteristics (age, sex, depression), dose variation, symptom~          severity, and concurrent infusion therapy moderate the impact of the novel intervention~          on adherence at 4, 8, and 12 weeks.~        2. To test the impact of the novel intervention on dose alterations, emergency department~          visits and hospital admissions over the 12 weeks in order to support the translation of~          this system into oncology practices.~   "
77484|NCT02043171|"~     Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is~     accompanied by a loss of muscle function which can lead to diminished quality of life and~     more importantly can lead to serious fall requiring medical treatment. The investigators~     hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to~     decreased falls and to improved quality of life (QOL) for older adults. The investigators~     further hypothesize that the addition of a modest exercise regimen to these supplements will~     enhance the synergistic effects of both Calcium-HMB and Vitamin D.~      Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will~     consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer;~     b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility,~     balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g)~     having blood drawn for biochemical measurements. Testing will be performed at the baseline~     (0 months) and at 3, 6, 9, and 12 months.~   "
77485|NCT02043158|"~     The goal of this research study is to learn about diet and exercise habits, emotions, and~     social support in the lives of women with ovarian cancer.~   "
77486|NCT02043145|"~     This post marketing surveillance study in Korea will evaluate the safety and efficacy of~     BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of~     care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar~     lines in clinical practice.~   "
77487|NCT02043132|"~     To the Investigators' knowledge, TXA has not been studied in the setting of reverse total~     shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing~     perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this~     study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates~     in patients undergoing reverse total shoulder arthroplasty.~   "
77488|NCT02043119|"~     Currently, healthy mothers willing to breastfeed their babies are discharged from the~     hospital on an average 2 days after a vaginal delivery or 3.5 days after a C-section, at a~     time where breastfeeding is far to be well established. Following discharge, women can~     access breastfeeding support from Public Health Units, lactation consultants, health care~     providers, and Internet (e.g. from breastfeeding associations). Despite the current support,~     duration and exclusivity rates of breastfeeding drop precipitously in the first weeks and~     months after birth.~      We have obtained funding from the Ontario Ministry of Health and Long Term Care to evaluate~     the efficacy and cost effectiveness of a post-partum clinic based in the community. This~     clinic, staffed by a family physician (in the morning), a registered nurse and a lactation~     consultant, will provide breastfeeding support during the first month after delivery as well~     as ensure a safe transition from hospital to the community for mothers and newborn babies.~     The clinic, affiliated with TOH, will be found at Harmony Medical Centre, 152 Cleopatra~     Drive, located south-west of downtown, a 15 minute drive from the Civic campus and 20~     minutes from the General campus. The Harmony Clinic has abundant parking (free on the street~     or a small fee inside the associated lot) and is fully accessible.~      In its initial phase, the future clinic would enroll only women willing to participate in a~     research program to evaluate this new program. The clinic will be opening in November 2013~     and currently (July - October 2013) we are conducting a pilot study to test feasibility of~     recruitment and test the surveys and database for this project. Women will be recruited at~     the Ottawa Hospital (General and Civic campus) and randomized to either receive~     standard-care or to be given access to the post-partum clinic and be discharged within~     approximately 24 hours following a vaginal delivery or 48 hours following a C-section. They~     will have an appointment booked at the breastfeeding clinic within 48 hours after discharge~     for maternal and neonatal care as well as breastfeeding support. Enrolled women will have~     access to additional clinic visits for one month after delivery. Information will be~     collected from their medical chart as well as through surveys that will be sent to them at~     15 days, 30 days and 3 months after delivery. We will compare the data and information on~     the experience of women who attended the breastfeeding clinic and those who did not attend~     the clinic. With this data we will be able to determine if this type of breastfeeding clinic~     is beneficial to new mothers and their newborn babies and if it really does increase the~     exclusive breastfeeding rate at 3 months (primary outcome).~   "
77489|NCT02043106|"~     Participants will be asked to complete three different tests (standing, stepping and~     assisted walking) and will experience three different experimental conditions during each~     test. The three conditions are types of vibratory plantar cutaneous stimulation, which~     include no vibratory stimulation, submaximal vibratory stimulation and supramaximal~     vibratory stimulation. In the first condition, participants will experience no stimulation~     applied to any part of the body. In the second condition, a submaximal vibratory stimulus~     will be delivered at 90% of the participant's threshold to the surface of the foot. In the~     third condition, a supramaximal vibratory stimulus will be delivered at three times the~     participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and~     supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is~     positive then this protocol will also be presented in incomplete spinal cord injuried~     participants.~   "
77490|NCT02043093|"~     The purpose of this study is to evaluate the impact of the school-based Sources of Strength~     program in reducing suicidal behaviors in the population of high school students and~     determine how the program works (mechanisms of change). Sources of Strength trains diverse~     high school students as Peer Leaders, who conduct school-wide prevention messaging~     activities with ongoing adult mentoring designed to increase positive coping norms and~     practices, help-seeking and increase youth-adult connections. Sources of Strength is~     expected to enhance school coping practices, increase help-seeking among distressed and~     suicidal youth, and reduce the number of students in the population who attempt suicide. A~     total of 40 high schools in primarily rural and micropolitan regions of New York State and~     North Dakota will participate in this study that uses a randomized wait-listed design.~   "
77491|NCT02043080|"~     This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in~     HIV-infected adults and paediatric patients as a means to obtain faster, more accurate TB~     diagnosis.~   "
77492|NCT02043067|"~     This study will examine an enhanced protocol to systematically screen a cohort of 400 new~     HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).~   "
77493|NCT02043054|"~     There are recent advances in therapies for the treatment of Type 2 Diabetes Mellitus (T2DM)~     which include the GLP1 analogues and the DPP IV inhibitors. Both of these therapies target~     the incretin system using different methods to elevate/maintain circulating levels of GLP1~     to subsequently achieve improved blood sugar control. Interestingly, GLP1 analogues have~     been reported not only to improve blood sugar control but to additionally induce weight-loss~     and emerging experimental evidence has shown it may have beneficial effects on the heart's~     structure and function. Due to the profile of this condition being a lot worse and younger~     patients having greater CVD risk, a therapy offering multiple positive effects, in~     particular the potential cardiometabolic effects, make this line of therapy attractive in~     this patient population.~      The aim of this research is to investigate the cardiometabolic effects of Liraglutide (GLP1~     analogue) compared to that of its clinically relevant comparator Sitagliptin (DPP IV~     inhibitor).~   "
77494|NCT02043041|"~     We will invite a convenience sample of up to 45 enrolled subjects to participate in an~     optional, self-administered blood specimen collection procedure to determine optimal~     procedures for collection.~   "
77495|NCT02043028|"~     To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage~     with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on~     a bed.This work is the validation study to demonstrate that the kneeling stool could be used~     for high quality hospital cardiopulmonary resuscitation (CPR) with the kneeling posture. We~     hypothesized that the quality of chest compression with a kneeling posture using the~     kneeling stool is equal to or superior to CC with a standing posture using the height~     adjustment mechanism of the bed.~   "
77496|NCT02043015|"~     The purpose of this study is to evaluate the acceptability and uptake of a combination~     package of biomedical, behavioral and community-level HIV prevention interventions and~     services for men who have sex with men (MSM) in South Africa.~   "
77497|NCT02043002|"~     Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an~     active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is~     primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does~     not harbor a mutation but respond as well. Identifying these patients is a problem and~     methods are lacking.~      Studies have shown that an early 18F FDG-PET might can predict response and outcome in these~     patients, but further studies are needed to confirm these findings.~   "
77498|NCT02042989|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of MLN9708 and vorinostat that can be given to patients with advanced solid~     tumors. The safety of these drugs will also be studied.~   "
77499|NCT02042976|"~     The purpose of the study is to determine the efficacy of mindfulness-based cognitive therapy~     (MBCT) as an add-on to pulmonary rehabilitation (treatment as usual, TAU) in chronic~     obstructive pulmonary disease (COPD).~      The investigators hypothesize that compared to treatment-as-usual, the add-on of MBCT will~     result in improved psychological (anxiety, depression, QoL) and physical outcomes (physical~     health status, activity level). Furthermore, the investigators will explore the possible~     moderating role of individual differences in sociodemographic and disease-related~     characteristics and mediating role of self-efficacy and self-compassion for the hypothesised~     effect.~   "
77500|NCT02042963|"~     KNOW-KT (KoreaN cohort study for Outcome in patients With KT: A 9-year Longitudinal cohort~     study of the Korean adult KT patients), funded by Korea Center for Disease Control and~     Prevention (KCDC) was established in 2012 by a group of transplant physicians, transplant~     surgeons, nephrologists, epidemiologists, and biostatisticians in Korea.~      We aimed to establish an adult KT cohort, to investigate the renal allograft outcomes,~     mortality, complications, and to explore traditional or nontraditional risk factors for~     morbidity and mortality. We established a bio-bank to integrate clinical and biological~     information. Here, we report design and method of the KNOW-KT.~   "
77501|NCT02042950|"~     The goal of this clinical research study is to learn if carfilzomib can help control~     relapsed or refractory MCL. The safety of this drug will also be studied.~   "
77502|NCT02042937|"~     Can participants enhance gluteus maximus recruitment during a single-leg squat test~     following a neuromuscular training program?~   "
77503|NCT02042924|"~     This is a pilot sub-study of patients receiving myeloablative transplant using total body~     irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The~     objective of this stub-study is to estimate the heterogeneity in cellular proliferation~     (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured~     using whole body water-fat MRI) using positron emission tomography imaging. This will be~     used to design future trials as well as to determine the feasibility of PET and MRI imaging.~   "
77504|NCT02042911|"~     The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day~     intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic~     leukemia.~   "
77505|NCT02042898|"~     TRICS-III is an international, multi-centre, open-label randomized controlled trial of two~     commonly used transfusion strategies in high risk patients having cardiac surgery using a~     non-inferiority trial design.~   "
77513|NCT02042794|"~     Liver resection is an operation to remove the diseased part of the liver. The liver is~     supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75%~     respectively of the total blood flow with 50% oxygen from each vessel. During liver~     resection it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid~     bleeding. Clamping both the vessels deprives the unaffected liver from nutrients required~     for survival. Reinstating the blood supply causes further damage by pouring harmful~     substances into the liver, which accumulate during the clamping. We hypothesize that not~     clamping the oxygen rich hepatic artery will cause less damage to the liver.~      Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the~     latter will result in less tissue injury and thereby fewer complications. Initially we aim~     to conduct a pilot study. The main objective is to ensure that patients can be successfully~     recruited and that data capture is complete. The secondary outcomes will be development of~     infective complications by 30 days following surgery, bleeding and blood transfusion~     requirements, heart/chest complications, recovery of liver functions, growth of remnant~     liver, death within 30 days following surgery, length of high dependency unit/hospital stay~     and quality of life at 3 months after surgery.~      There is published literature on the safety of this method and in the event of any~     intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre.~     The Liver Unit at St James's University Hospital has four surgeons performing around 270~     liver cancer resections per year, of which nearly 160 are for bowel cancer spread.~     Considering the team's experience in research and liver surgery, we believe it is well~     placed to conduct the trial in a safe and efficient manner.~   "
77514|NCT02042781|"~     This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused~     PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the~     study will explore whether PG545 exposure results in changes to chemicals produced by the~     body that are associated with cancer growth and spread.~   "
77515|NCT02042768|"~     Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the~     most commonly used dialysate contains unphysiological amounts of glucose, a high proportion~     of which is absorbed. Recent analysis of the Global Fluid Study, has established that in~     non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate~     glucose load and is a predictor of death. By utilising clinical data and additional~     biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm~     this finding, define the relationship between dialysate glucose exposure according to~     prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia ,~     and establish the role that impaired insulin sensitivity plays in blood glucose levels.~     Furthermore the investigators will explore the hypothesis that insulin resistance is~     associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit~     from intra-peritoneal carnitine supplementation.~      PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed~     clinical data, including glucose exposure and samples of dialysate. and blood which will be~     stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique~     failure).~      Multivariate regression will be used to establish determinants of the non-fasting blood~     glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g.~     modality, dwell lengths, fill volumes, and dialysate type and concentration specifically~     seeking to identify prescriptions that minimise the systemic effects) combined with measures~     of insulin resistance. The investigators will establish whether blood glucose predicts~     survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore~     the relationship of other biomarkers to survival.~   "
77516|NCT02042755|"~     The principal objective of the study is to determine the visual acuity at far, intermediate~     and near distances tested with optotypes at different distances from the eyes and tested~     with defocus addition lenses of patients implanted bilaterally with the POD 26P AY~     FineVision.~      Secondary objective will be to test the glare and contrast sensitivity.~   "
77517|NCT02042742|"~     A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2.~     Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with~     3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an~     8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the~     consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The~     endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical~     markers), inflammatory markers and nutritional status were evaluated before and after each~     phase. Previously a pilot study was completed with no placebo (n=30) to determinate the~     effective dose of Functional Supplement.~   "
77518|NCT02042729|"~     The purpose of this study is to investigate the safety and pharmacokinetics of new patch~     formulation (tape) of E2022 by conducting patch test.~   "
77519|NCT02042716|"~     Preterm birth and perinatal events related can interrupt microscopic maturation of the~     developing white matter leading to diffuse injury and subsequent neurocognitive impairments.~     Brain maturation can be studied using diffusion tensor imaging but is difficult to assess~     early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could~     be of interest in this clinical setting. This technique, already investigated in adults~     (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.~      Objective:~      To describe the feasibility and reproducibility of quantitative elasticity mapping in~     preterm infants and to correlate to gestational age.~      Methods:~      SSI is a quantitative stiffness imaging technique based on the combination of a remote~     palpation induced into tissues by the radiation force a focused ultrasonic beam and an~     ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real~     time the displacements induced by the propagation of the resulting shear waves. For each~     pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the~     local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a~     new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en~     Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between~     25 and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each~     area of interest both on right and left sides and stiffness was measured using a unique ROI~     of 2.5 cm².~   "
77520|NCT02042703|"~     The purpose of this study is to use a special eye imaging technique, anterior segment~     optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of~     the eye that helps you to see clearly by directing images of light onto the back of your~     eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common~     condition that has many ways of showing up in the eye, including the formation of deposits~     in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance~     of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to~     collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high~     resolution pictures of the eye without requiring contact with the eye. We will compare lens~     images of subjects with exfoliation syndrome to those of subjects with primary open angle~     glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis~     of exfoliation syndrome to track disease progression and see how they respond to possible~     treatments. We also hope that with this imaging technology we can detect early changes in~     currently unaffected eyes, which could be useful for predicting which patients may develop~     the disease.~   "
77523|NCT02042664|"~     Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they~     lower blood glucose level (by enhancement of glucose-dependent insulin secretion and~     suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing~     of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on~     cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease~     systolic blood pressure, improve endothelial function and have beneficial effects on~     myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on~     myocardial function in type 2 obese diabetic.~      Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes~     mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with~     diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac~     output, normalized stroke volume, LV mass and normalized end diastolic volume), and~     diastolic function. However, no study has evaluated the impact of Glucagon-like peptide-1~     (GLP-1) receptor agonist in obese diabetics on myocardial TG content.~      Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an~     important risk factor for cardiac diseases. We and others have already evidenced a~     correlation between the volume of epicardial adipose tissue and the presence or the severity~     of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of~     EAT is mostly unknown.~   "
77524|NCT02042651|"~     Introduction:~      Chronic pelvic pain with unknown pathology is a condition that affects both men and women.~     the condition is defined as pelvic pain lasting for a minimum of 6 months without any known~     etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity~     extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount~     of energy approximately 5 cm under the skin of the patient without damaging the skin. This~     have been shown to increase blood flow and accelerate healing which could also be beneficial~     in chronic pelvic pain patients.The purpose of this study is to investigate the effects of~     LIESWT on chronic pelvic pain.~      Methods:~      All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.~      The investigators anticipate to include 100 chronic pelvic pain patients in the study.~      included patients will be randomized into two groups: active treatment or sham treatment.~      All patients will be required to provide a urine sample and a semen sample prior to final~     inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo~     a digital rectal exploration and finally all patients is required to provide an informed~     consent in order to be included in the study.~      A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will~     receive the treatment once a week until their symptoms have seized or for a maximum of 6~     times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy~     density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.~      Participants will fill out a questionnaire one week before the treatment, one week, four~     weeks, and twelve weeks after the last treatment.~      Possible gains from this study:~      The investigators hope to provide further evidence for this treatment and consequently be~     able to offer the treatment as an alternative to the very limited array of treatments~     existing for this group of patients today.~      Ethics, funding, and publication:~      The study is performed in compliance with the Helsinki declaration. External funding have~     been applied for but not yet received. Participants will be informed of sources of external~     funding. The result of the study will be published as soon as possible, preferably in a~     peer-reviewed international journal.~   "
77525|NCT02042638|"~     Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic~     hypogonadism.~   "
77526|NCT02042625|"~     Low body temperature (hypothermia) is often observed in anesthetized patients. Mild~     hypothermia increases complications such as surgical blood loss, postanesthesia recovery and~     the duration of hospitalization. To assess body temperature and minimize hypothermia-related~     complications, it is important to have accurate and reliable methods of measuring~     intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the~     throat from the nose) probe through one of the nostrils. However, there is no consensus or~     guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is~     being done to determine the insertion depth (or range of depths) that best approximates core~     temperature, which is temperature of the vital organs, e.g. heart, liver and lungs.~      Participation in the trial will occur on the day of surgery. The subject will be asked to~     breathe through one nostril and then the other before receiving anesthesia. The less~     congested nostril will be selected for study. If there is no difference, then the~     investigator will use the right nostril.~      Once under anesthesia, an esophageal temperature probe will be inserted to serve as a~     reference core temperature, which is used routinely in surgery. Then the nasopharyngeal~     probe will be inserted into the nostril.~      Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after~     anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a~     3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be~     recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time,~     until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal~     and esophageal temperatures obtained.~   "
77527|NCT02042612|"~     Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients~   "
77528|NCT02042599|"~     Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute~     kidney failure~   "
77529|NCT02042586|"~     The investigators believe that the application of non-linear methods of analysis using the~     ganglion and neural network technique will make it possible to analyse all of the complex~     data obtained in patients with hip osteoarthritis before and then after total hip~     replacement, and should allow us to identify a combination of objective variables to~     classify the surgery as  successful  or  unsuccessful .~      To this end, the study will take place as follows:~      Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis~     of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor~     activity carried out between 6 months and 1 year after the THR Step 5: Data analysis~   "
77538|NCT02042469|"~     Enrollment of patients in CR may be impacted by their levels of awareness and attitude~     toward participation. Our study aims at assessing the awareness and willingness to~     participate in CR and identifying the barriers and influencing factors for participation.~      A cross-sectional study was performed using an interview-based questionnaire composed of~     close-ended questions conducted by trained research coordinators. Descriptive statistics,~     univariate and multivariate analyses were applied.~   "
77539|NCT02042456|"~     This study is investigating whether automated whole breast ultrasound can improve detection~     of cancer in breast cancer screening when used as a supplement to mammography or as a~     supplement to digital breast tomosynthesis~   "
77634|NCT02041195|"~     The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC)~     injectable formulation of RM-493 in healthy obese subjects on mean percent body weight loss~     and other weight loss parameters, as well as Pharmacokinetic (PK) profile. The study is~     designed to evaluate the efficacy and tolerability of RM-493 administered once or twice~     daily. The study drug (RM-493 and placebo) will be administered in a blinded fashion.~   "
77530|NCT02042573|"~     Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of~     patients with depression, is responsible for a decrease in the expression of the C-FOS and~     DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be~     explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS~     causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate~     with the antidepressant effect [Hausmann, 2000].~      According to this hypothesis, the genetic effect related to medical antidepressant~     treatments deserves to be studied because we could observe:~        -  either a decrease in the expression of the C-FOS and DUSP1 genes related to the~          antidepressant effect of the medical antidepressant treatment,~        -  or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral~          activation due to the medical antidepressant treatment.~      In summary, we wish to determine the validity of this hypothesis by comparing the genetic~     effect of rTMS with that of medical antidepressants to know if:~        -  this genetic effect is specific to rTMS or common rTMS and medical antidepressants~        -  this effect correlates with the clinical improvement induced by rTMS and by medical~          antidepressants~        -  this early modification in the C-FOS and DUSP1 genes may be predictor of the~          therapeutic response to rTMS and antidepressants (early decrease in gene expression)~        -  the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a~          predictor of therapeutic resistance to rTMS and/or medical antidepressants.~   "
77531|NCT02042560|"~     This is a multicentre, open, case/control study aiming to investigate in a quantitative and~     functional manner the different populations of immune cells in auto-immune thrombopenia~     with:~        1. Disturbed T lymphocyte response~             1. TH1 response predominant over TH2 response~             2. Implication of TH17 L~             3. Quantitative and/or functional deficit of regulatory T L~             4. Involvement anti-apoptotic mechanisms of TL~        2. Disturbed B lymphocyte response~             1. Hyperactivation of B lymphocytes and involvement of memory BL~             2. Secretion of autoantibodies~        3. Implication of ImC and disturbance of the pDC/mDC ratio~        4. Study of splenic immune cells (TL, BL, DC)~      The study will in no way modify the investigation procedures (diagnostic and therapeutic~     strategy), which will be carried out as usual.~      Blood samples related to the study will be taken in the context of a pathology investigation~     and will not require an additional puncture.~      Spleen samples will be obtained with the consent of the patient if therapeutic splenectomy~     is planned, which is usually proposed to patients with ITP.~   "
77532|NCT02042547|"~     Before la surgery:~      Transthoracic cardiac echography will be done systematically, to measure among other things~     the size of the left atrium.~      During surgery:~      Surgery under extracorporeal circulation: tissue samples will be harvested from the right~     atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before~     declamping of the aorta (T1= post-ischemia sample).~      Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG~     (T0) and a second sample after CABG (T1).~      In parallel with the harvesting of cardiac tissue, blood samples will be taken at different~     times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the~     anesthetists.~      After the surgery:~      Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an~     observation notebook. The biological samples will be analysed immediately and the biological~     data obtained will be recorded in the observation notebook.~   "
77533|NCT02042534|"~     Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for~     early recurrence. In acute stage, guidelines recommend aspirin, but do not recommend~     anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a~     limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early~     anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke~     patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or~     immediate warfarin administration (sometimes with heparin bridging) for minor stroke.~     However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the~     following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2)~     delayed action and transient paradoxical thrombogenic tendency due to the inhibition of~     protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of~     hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin,~     rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate~     anticoagulation efficacy.~      Goal The current trial will examine whether early initiation (within 5 days from stroke~     onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial~     bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke~     due to AF.~   "
77534|NCT02042521|"~     The purpose of this study is to determine whether a dietary supplement (DS) is effective in~     protecting against sad mood during early cigarette withdrawal. This study will also assess~     whether the dietary supplement will be well tolerated during early cigarette withdrawal.~   "
77535|NCT02042508|"~     This single-centre study was carried out in collaboration with the Cardiovascular Research~     Laboratory of Harvard University (Boston, USA). This preliminary study does not include a~     control group.~      The aim of this study was to investigate the effect of a hybrid reconditioning programme~     (electrostimulation of the lower limb muscles associated with voluntary strengthening of the~     upper limbs) on a specially developed rowing machine in patients presenting stabilized~     paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic~     capacity (VO2max) between the start and end of the 9-month reconditioning programme.~   "
77536|NCT02042495|"~     The investigators will explore the chemopreventive role of metformin. The purpose of this~     study is to determine whether, among patients with endometrial cancer, treatment with the~     currently approved insulin sensitizing drug metformin increases or decreases pathway~     activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa~     study of metformin to be used to the pre-operative period of women diagnosed with~     endometrial cancer by comparing their endometrial biopsy specimens taken at their initial~     visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.~   "
77537|NCT02042482|"~     The purpose of this study is determine whether combination Q10 , L-carnitine and~     multivitamin and mineral complex is effective in treatment of patients with low and~     intermidiate1-2 risk Myelodysplastic syndrome~   "
77540|NCT02042443|"~     This randomized phase II trial studies how well trametinib or combination chemotherapy works~     in treating patients with refractory or advanced biliary or gallbladder cancer or that~     cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil,~     leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether giving trametinib is more effective than combination~     chemotherapy in treating patients with biliary or gallbladder cancer.~   "
77541|NCT02042430|"~     This pilot clinical trial studies epacadostat before surgery in treating patients with newly~     diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.~     Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
77542|NCT02042417|"~     We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory.~     Therefore, we take bloodsamples (capillary and venous blood) and put it on the tool. After~     the measuring, a number is shown = INR.~      We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory~     value to illustrate the applicability in the clinical daily routine.~   "
77543|NCT02042404|"~     The EarLens System is an assistive hearing device that is intended to provide amplification~     for the treatment of patients with sensorineural hearing impairment. The purpose of this~     multi-center definitive study is to assess the safety and efficacy of the EarLens System for~     subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully~     activated system in their daily lives for a 4 month period of time. This study is designed~     to support US and International marketing applications to commercialize the EarLens System.~     The main efficacy hypothesis is that the EarLens System will be shown to improve speech~     understanding in quiet.~   "
77544|NCT02042391|"~     Post-transplant lymphoproliferative disorders (PTLD) differ clinically from lymphoma in the~     general (immunocompetent) population due to their higher incidence and their frequent~     association with Epstein-Barr virus. Previous clinical trials have shown their remarkably~     good response to rituximab as well as to chemotherapy.~      The PTLD-1 trial demonstrated the efficacy and safety of sequential immunochemotherapy with~     4 courses of rituximab IV followed by 4 cycles of CHOP chemotherapy. Compared to trials of~     rituximab monotherapy in PTLD, median overall survival was extended from 2.4 to 6.5 years.~     Compared to previous trials of chemotherapy, complications were reduced. In addition, we~     noted that those patients who already had a good response to the first four cycles of~     rituximab did better overall than those who did not. As a consequence, the PTLD-1/3 trial~     introduced risk-stratification in sequential treatment according to the response to the~     first 4 courses of rituximab monotherapy. Those patients with a complete remission went on~     to receive four further courses of rituximab whereas those who did not received rituximab~     and CHOP chemotherapy. Interim results have demonstrated that it is safe to restrict~     chemotherapy treatment in this manner and thus established the concept of treatment~     stratification based on the response to rituximab.~      The PTLD-2 trial is the next step in the development of this strategy. Compared to the~     PTLD-1/3 trial, the key difference is the use of subcutaneous instead of intravenous~     rituximab application. Interim results from an ongoing trial of patients with follicular~     lymphoma (NCT01200758) have shown that subcutaneous administration results in increased~     blood levels and in non-inferior remission rates. Furthermore, the stratification strategy~     is refined based on observations from the previous PTLD-1 and PTLD1/3 trials: Risk groups~     are now defined not only based on response to rituximab therapy but also on the~     international prognostic index (IPI, a well-established lymphoma risk score) and the~     transplanted organ. The major advantage of this new stratification is an extended low-risk~     group that is eligible for subcutaneous rituximab monotherapy: Patients with a low risk of~     disease progression, defined as those who achieve a complete remission after the first four~     courses of subcutaneous rituximab monotherapy and those with an IPI of 0 to 2 who achieve a~     partial remission at interim staging, will go on with rituximab monotherapy. Patients with~     high IPI who achieve a partial remission, patients with stable disease at interim staging~     and non-thoracic transplant recipients with progressive disease at interim staging will be~     considered high risk. These patients will go on with 4 cycles of rituximab plus CHOP~     chemotherapy similar to the PTLD-1/3 protocol. Thoracic transplant recipients refractory to~     rituximab will be considered very high risk and will go on with rituximab subcutaneous plus~     alternating chemotherapy with CHOP and DHAOx.~      The trial hypothesis is that the new protocol will improve the event-free survival, a~     measure integrating unfavorable events such as death, disease progression and treatment~     complications, particularly infections, in the low risk-group compared to the results of the~     PTLD-1 trial. In very high-risk patients data from the PTLD-1 and PTLD-1/3 trial have shown~     that the current treatment is not sufficient to control the disease. Death due to disease~     progression was observed in more than 80% of patients. Here, rituximab combined with~     alternating chemotherapy cycles of CHOP and DHAOx (+GCSF) may increase treatment efficacy~     with an acceptable toxicity profile.~      In summary, the PTLD-2 trials tests if the substitution of subcutaneous for intravenous~     rituximab and an updated stratification strategy that deescalates treatment for those at low~     risk and escalates treatment for those at very high risk can further improve the overall~     efficacy and safety of PTLD therapy.~   "
77545|NCT02042378|"~     The purpose of this study is to determine whether oral rucaparib is effective in the~     treatment of patients with locally advanced or metastatic pancreatic cancer and a known~     deleterious BRCA mutation.~   "
77546|NCT02042365|"~     The primary purpose of the study is to test the feasibility of a protocol of enhanced~     recovery after surgery for reducing the total length of hospital stay in a large scale~     setting~   "
77547|NCT02042352|"~     The primary aim of the present study is to investigate the vaginal microbiota of infertile~     women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH~     and a PCR method supported with conventional Gram staining.~      We hypothesize that the molecular based tests will prove more efficient than conventional~     Gram staining and that they have a place in future IVF diagnostics.~   "
77548|NCT02042339|"~     Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient~     pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in~     an increase of total oxygen in the body. The elevated tissue levels of oxygen may persist~     for hours, instigating healing processes in wounds caused by disturbances in of perfusion in~     small vessels, a condition often found in patient with diabetes.~      We plan a prospective, double-blind randomized clinical study in 80 patients with chronic~     diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO~     at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be~     identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number~     of monitoring and imaging procedures will be done, cells in the bloodstream indicating~     improved healing will be determined.~      Hypothesis: HBO will instigate the healing process in the majority of patients with chronic~     diabetic leg ulcer, provided the patency of the large vessels is given.~   "
77549|NCT02042326|"~     The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to~     decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).~      Sirolimus has properties that reduce the activity of the immune system (immunosuppressant),~     to fight against the proliferation of cancer cells (anti- tumor) and also reduce the~     proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant~     patients to prevent organ transplant rejection. Many animal and laboratory studies were~     carried out and demonstrate in particular the activity of sirolimus on vessels. It is this~     anti- vascular effect that could help treat arteriovenous malformations.~   "
77550|NCT02042313|"~     Esophagectomy is a major surgical procedure often associated with significant morbidity and~     mortality and significant level of postoperative pain. In contrast to open esophagectomy~     where epidural pain control has been considered as a gold standard and could be crucial in~     affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to~     be established. We would like to compare continuous epidural analgesia and continuous~     paravertebral block combined with single shot subcostal transversus abdominis plane (TAP)~     block in the analgesic effects, levels of cytokines, and postoperative complications in~     patients receiving MIE.~   "
77551|NCT02042300|"~     The purpose of this study is to evaluate effectiveness and safety of XIENCE xpedition/Alpine~     in Routine Clinical Practice~   "
77552|NCT02042287|"~     Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age.~     Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and~     homogenous and has a fishy smell especially after intercourse. It is of importance to treat~     women with BV, as this condition is associated with serious risks, such as an increased risk~     of preterm birth in pregnant women, and particular vulnerability to the acquisition of~     sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the~     microbiologic composition of the vaginal flora. The treatment of choice for BV is oral~     metronidazole for 7 days. Although the available antibiotic therapies produce good results~     in the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of~     patients, with long-term recurrence approaching 85%. An alternative treatment option may be~     a vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is~     to assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral~     metronidazole in the treatment of BV.~   "
77569|NCT02042066|"~     Low intensity shockwaves have been proven in animal and human studies to increase tissue~     perfusion, promote angiogenesis and tissue regeneration and improve neural function.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of~     patients with resistant hypertension.~   "
77553|NCT02042274|"~     Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide~     cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of~     fish oil supplements has been reported to reduce blood triglyceride levels, and influence~     glucose homeostasis and whole-body inflammation. However, recent evidence highlights~     important gaps in our understanding with respect to the impact of fish oil supplements on~     health; specifically, not everyone responds to these supplements in the same manner. The~     goal of this research is to explore how an individual's genetic make-up may modify their~     response to fish oil supplements.~   "
77554|NCT02042261|"~     Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs,~     individualized therapy using plasma drug concentrations and minimal inhibitory concentration~     (MIC) determination may be of importance. This concept is defined as therapeutic drug~     monitoring (TDM).~      In this pilot study our hypothesis is that the ratio between MIC and drug concentration data~     is correlated to the bacterial load measured as time to positive liquid culture (TTP).~      In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients~     with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium~     tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined~     at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures~     will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured~     in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year~     after completion of treatment.~   "
77555|NCT02042248|"~     The purpose of this study is to:~        -  find out the intensity and duration of the immune response after multiple injections of~          the investigational study product AGS-004 made from one's own dendritic cells and one's~          own strain of HIV;~        -  understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting~          CD4+ cells prior to and following administration of AGS- 004.~        -  find out if low levels of HIV virus that are not detectable by standard HIV RNA assays~          will decrease following the administration of AGS-004.~        -  find out if it is safe to give individuals with HIV multiple injections of AGS-004 made~          from the person's own dendritic cells and their own strain of HIV.~        -  find out if administration of AGS-004 decreases the amount of latent HIV infection in~          resting CD4 cells~   "
77556|NCT02042235|"~     In studies of children born at term, language delay at the age of 2 years exhibits a~     spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no~     recommendation for speech therapy before the age of 3 years. However, for term-born~     children, parent-implemented language interventions conducted during the third year of life~     have already shown a positive short-term effect on language skills. In these interventions,~     a skilled interventionist, generally a speech therapist, teaches parents how to use specific~     language strategies with their child.~      The investigators' hypothesis is that such parent-implemented interventions would be~     particularly appropriate at short and medium term for the improvement of linguistic~     performances in very preterm children, a population with a high prevalence of early language~     delay. Currently, there is an opportunity to partly nest an intervention trial in a national~     prospective population-based cohort of very preterm children, the EPIPAGE (Etude~     EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies~     born alive in France in 2011. This situation provides considerable methodological~     advantages.~   "
77557|NCT02042222|"~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped.~     This can result in painful episodes, serious infections, chronic anemia (a decrease in the~     number of red blood cells), and damage to body organs. Hydroxyurea therapy offers~     significant benefits for infants, children, and adolescents with sickle cell anemia. These~     include a reduction in the frequency of pain crises and acute chest syndrome (inflammation~     of the lungs) and an increase in hemoglobin (the oxygen-carrying protein) in the blood.~     Patients on hydroxyurea who receive a maximum tolerated dose (MTD) that is specific for them~     have greater clinical benefit than those who receive a standard lower dose. There is,~     however, no way currently to predict the MTD for individual patients. As such, MTD for each~     patient is currently determined by gradual increases in the dose over several months. This~     process is time-consuming, requires monthly clinic visits, and delays the benefits of~     hydroxyurea therapy.~      Our research group has come up with an equation that could be used to predict each patient's~     MTD using baseline clinical and laboratory measures before starting hydroxyurea treatment.~     The purpose of this research study is to compare the use of our equation for predicting MTD~     to the current standard practice of gradually increasing the hydroxyurea dose until MTD is~     reached. We want to see if the use of our predictive equation will allow us to achieve MTD~     faster and with no more side effects than with the standard practice.~   "
77558|NCT02042209|"~     Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious~     illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality~     remains high: half of the deaths occur during the first two hours. The benefit of an early~     diagnosis of ACS in term of morbidity and mortality is well established. Identification of~     the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital~     emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is~     thus a key element of the prognosis.~      The aim of the study is to build a telephone predictive score of ACS at the triage of calls~     for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will~     authorize the validation of a unique score or two distinct scores for men and women.~   "
77570|NCT02042053|"~     This study intents to provide an initial evaluation of the utility of positron emission~     tomography and magnetic resonance (PET/MR) imaging measures for the prediction of~     immunological response to Sipuleucel T (SipT) therapy.~   "
77642|NCT02041091|"~     The purpose of this study is to evaluate the amount of tabalumab in the blood after it is~     given by two different injection methods - A traditional syringe or a spring loaded syringe~     for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.~   "
77643|NCT02041078|"~     Intrahepatic division of the hepatic vein is associated with less blood loss than~     extrahepatic dissection and division of the right hepatic vein.~   "
77644|NCT02041065|"~     Before liver transection patients are allocated to either waterjet or CUSA to divide the~     liver parenchyma.~   "
77645|NCT02041052|"~     A small gastric remnant after whipple resection improves gastric emptying and therefore~     prevents the development of delayed gastric emptying.~   "
77559|NCT02042196|"~     As women get older and go through menopause, levels of the female reproductive hormone~     estradiol decrease to low levels. Also with aging, the functioning of the arteries declines.~     Over time this vascular dysfunction can lead to health problems such as high blood pressure~     and heart disease. This study is being done to help determine what causes arteries to become~     unhealthy in postmenopausal women, who have low levels of the female reproductive hormone~     estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a~     natural substance in the body that can cause the arteries to expand, explains why arteries~     become unhealthy in women with low levels of estradiol. To answer this question, we will~     study how vascular function changes with a medication that causes a short-term increase in~     BH4 levels when estradiol is lowered with a medication, compared to when estradiol is~     normal. We will also determine whether the administration of the antioxidant vitamin C,~     along with the medication to increase BH4 levels, will normalize vascular health in~     perimenopausal and postmenopausal women, and in women who have their estradiol levels~     lowered.~   "
77560|NCT02042183|"~     A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to <~     18 years diagnosed with Functional Constipation~   "
77561|NCT02042170|"~     The purpose of this study is to assess dosing requirements and establish the efficacy of~     SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as~     multi-center, randomized, active comparator-controlled, parallel, open-label.~      45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of~     daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the~     other arm received daily hGH at 0.37 mg/kg/week.~      Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And~     patients randomized to daily hGH group injected for 6 days a week.~      Patients visited study centers five times, firstly at screening (Visit 1), at randomization~     (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for~     follow-up (Visit5).~   "
77562|NCT02042157|"~     Our expectations (hypotheses) are:~      Primary outcome~        1. Regular bidet use will improve quality of life around elimination in adults with~          impaired functional status. Functional status will be measured by activities of daily~          living (ADL).~        2. Regular bidet use by adults with impaired functional status will improve the quality of~          life around toileting for their caregivers.~           Secondary~        3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as~          measured by self-report) in adults with impaired functional status.~        4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult~          women with impaired functional status.~   "
77563|NCT02042144|"~     This study is a prospective observational cohort study. The study will be conducted in~     routine clinical practice settings. It is planned to enroll 1000 patients with metastatic~     Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for~     metastatic disease and for whom a decision has been made by the physician to treat with~     regorafenib according to local health authority approved label. It is the aim of this~     observational cohort study to further characterize safety and effectiveness of regorafenib~     in routine clinical practice setting. Healthcare resource utilization in the routine~     provision of care is becoming increasingly important from a health economics and outcomes~     research perspective. Therefore, another aim of this observational cohort study is to~     capture healthcare resource associated with the management of treatment emergent adverse~     events in the real world setting. The primary objective of this study is to further~     characterize safety of regorafenib use in routine clinical practice settings. The secondary~     objective of this study is to assess the effectiveness of regorafenib in routine clinical~     practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and~     Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in~     applicable countries.~   "
77564|NCT02042131|"~     The purpose of the proposed study is to identify the most effective brief interventions for~     reducing short-term risk for suicide attempts in real world military triage settings, and~     to identify potential mechanisms of change underlying the interventions' impact on~     subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used~     crisis interventions delivered as routine care in the mental health triage system: (1)~     Treatment As Usual (TAU); (2) Crisis Response Plan (CRP); or (3) Enhanced Crisis Response~     Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:~        1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly~          decreased risk for suicide attempts and hospitalization during follow-up relative to~          the crisis response plan alone (CRP) and treatment as usual (TAU).~        2. The crisis response plan (CRP) intervention will contribute to significantly decreased~          risk for suicide attempts and hospitalization during follow-up relative to treatment as~          usual (TAU).~        3. Greater ambivalence about suicide and faster recall of reasons for living will mediate~          the relationship between intervention and reduced risk for suicide attempt during~          follow-up.~   "
77565|NCT02042118|"~     The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs.~     face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital,~     Kampala, Uganda.~   "
77566|NCT02042105|"~     This is a post-marketing, observational, non-interventional, multi-central study of patients~     with non-small cell lung cancer (NSCLC), with data collected prospectively from medical~     records at inclusion. The primary objective is to obtain the epidemiologic data of~     anaplastic lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.~   "
77567|NCT02042092|"~     This study is a cross sectional comparison of the Color Doppler Ultrasonography (CDUS) and~     Magnetic Resonance Angiography (MRA) in patients diagnosed with sLVV. The supraaortic large~     vessels (aorta, carotid, subclavian, vertebral, and axillary arteries) and the temporal~     arteries of fifty patients suffering of sLVV will be examined by CDUS and MRA. The images~     will be evaluated by 2 blinded experts (one for CDUS and one for MRA). In addition, the~     intima media complex (IMC) thickness of the large vessels and temporal arteries will be~     measured by CDUS in 100 sex and age matched controls to the sLVV patients. Blood samples~     from patients and controls will be collected in order to perform genetic and cytokine~     analyses.~   "
77568|NCT02042079|"~     The purpose of this study is to evaluate the feasibility of endoscopic full-thickness~     resection with laparoscopic assistance.~   "
77571|NCT02042027|"~     The purpose of the study is to test the investigational drug Gamunex-C on the growth of~     blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the~     Moran Eye Center at the University of Utah.~      The cornea is the clear outer front part of the eye. In corneal neovascularization, blood~     vessels grow over the cornea. Corneal neovascularization and ocular anterior segment~     inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent~     scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is~     also a well recognized risk factor for corneal graft failure. In its natural state, the~     cornea is a site of immune privilege well suited to tissue transplantation. Once~     vascularized, there is direct exposure of corneal antigens to circulating host immune~     mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation~     Study].~      Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause~     irreversible scarring or destruction of the optical elements of the eye, which can~     compromise vision.~      Current standard of care for such conditions includes use of topical steroids and sometimes~     immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal~     neovascularization or melting.~      This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment~     of corneal neovascularization in the setting of corneal transplantation with~     neovascularization. Candidates for corneal transplantation with corneal neovascularization~     in one or more quadrants crossing more than 0.5mm over the limbus will be identified for~     inclusion in our study.~   "
77572|NCT02042014|"~     To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are~     benefitting from treatment with QTI571.~   "
77573|NCT02042001|"~     Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been~     associated with persistent central nervous system symptoms or mild or even asymptomatic~     neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is~     beneficial among patients who experience mild or asymptomatic~     neurocognitive/neuropsychiatric adverse events during EFV has not been explored yet.~      The proposed pilot study will examine whether switching from EFV-based regimen to single~     tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement~     among HIV-infected patients with mild/asymptomatic neurocognitive impairment or~     neuropsychiatric symptoms during EFV-containing antiretroviral treatment.~      Patients under stable treatment with EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and~     altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or~     more domains as assessed by neuropsychological assessment, will be randomized to immediate~     or deferred (12 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will~     be repeated after 12 and 24 weeks of follow-up and variations will be compared between~     groups.~   "
77574|NCT02041988|"~     In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce~     opioids administration during major urological surgery~   "
77575|NCT02041975|"~     To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals~   "
77576|NCT02041962|"~     This study will determine if a version of the chronic care model for individuals with mood~     disorders seen in small or solo practices can improve patient health.~   "
77577|NCT02041936|"~     The purpose of this study is to evaluate the short and intermediate term outcomes of the~     NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic~     cancer. In addition, the study will evaluate the efficacy of this device in treating~     symptoms of unresectable pancreatic cancer. The NanoKnife, System has been commercially~     available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System~     has received FDA clearance for the surgical ablation of soft tissue. It has not received~     clearance for the therapy or treatment of any specific disease or condition.~      Irreversible electroporation (IRE) has the potential to dramatically widen the treatment~     options for patients with pancreatic cancer. It provides a minimally invasive procedure that~     could potentially avoid radical surgery for smaller lesions, and it could potentially offer~     palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients~     with locally advanced unresectable disease.~   "
77578|NCT02041923|"~     Premature infants are at high risk of suboptimal health and development. This randomized~     clinical trial evaluated the impact of a developmentally based intervention, H-HOPE~     (Hospital-home transition: optimizing prematures' environment), for infants born between~     29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE~     will improve infant behavior, mother care for the infants, mother-infant interaction and~     will reduce health care costs.~   "
77579|NCT02041910|"~     Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans,~     Azoospermia affects about 1% of the male population and may be seen in up to 20% of male~     infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or~     absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated~     (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of~     men with Azoospermia. The purpose of this study is to assess the ability of bone marrow~     derived stem cells to differentiate into germ cells and their role in treatment of~     testicular Azoospermia~   "
77580|NCT02041897|"~     It is still controversial about the necessity of endoscopy ultrasound guide fine needle~     aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is~     to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.~   "
77581|NCT02041884|"~     The purpose of this study is to further evaluate the treatment for adults with ADHD used in~     our previous study (clinicaltrials.gov ID NCT01659164). It will now be converted to~     therapist supported, internet-delivered cognitive behavioral therapy (iCBT) with an~     additional smartphone application and evaluated through a randomized controlled trial during~     12 weeks. The patients will be randomized to one of three conditions~        -  an active treatment group where the intervention is based on cognitive - and~          dialectical behavioral therapy (CBT and DBT) and the mobile app.~        -  an active ICBT-treatment based on psychoeducation, a CBT stress-reduction program and~          Applied Relaxation, and~        -  treatment as usual (TAU) / waiting list.~      The main objective of the study is to evaluate if both of the treatment conditions will show~     better outcomes than TAU regarding decreased ADHD symptoms and increased functioning and~     life quality.~      Another objective is to evaluate if the group receiving the active iCBT treatment (based on~     CBT and DBT) will show better outcomes in comparison to the control group regarding ADHD~     symptoms, overall functioning and life quality.~   "
77583|NCT02041858|"~     Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem.~     The problem of alarm desensitization is multifaceted and is related to a high false alarm~     rate, poor positive predictive value, lack of alarm standardization and the large number of~     medical devices with built in alarms in use today. Cardiac monitor alarms are intended to~     notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of~     physiologic monitor alarms occur on monitored units each day. As a result, practitioners are~     highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death~     due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4%~     of monitor alarms are false or clinically insignificant. Alarm hazards is the number one~     medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care~     Research Institute) among the top 3 medical device hazards for the past three years (ECRI,~     2011). Delivering actionable alarm information to care providers is challenging given the~     significant number of false alarms.~      Ideally, alarms should activate for events in greatest need of clinical attention without~     increasing the risk of adverse patient outcomes. This is not the case with current~     monitoring technology which is designed for high sensitivity and low specificity.~     Practitioners must use clinical intuition for determining how conservatively alarms should~     be set to be most useful. There is no research evidence to support how best to set alarms~     without affecting patient outcomes.~      Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that~     the frequency of alarm signals can be reduced by more than 50% through an altered set of~     alarm parameters. This reduction in alarm signals has lead to an increase awareness of~     alarms that do occur as well as create a quieter, healing environment for patients. Although~     this change was not associated with a noticeable increase in adverse patient events, this~     important outcome was not rigorously studied.~      The specific aims of this pilot study is to determine if decreasing the number of alarms by~     using an altered set of alarm parameters has an effect on patient outcomes in an intensive~     care unit.~      This project may have a significant impact on patient safety. A decrease in noise at the~     bedside may result in less distraction to caregivers and may have a positive effect on~     patient recovery. It is expected that the altered set of monitor default parameters will~     result in a decrease in audible alarms without increasing clinically significant adverse~     patient events.~   "
77584|NCT02041845|"~     The majority of patients with limited disease small cell lung cancer (SCLC) experience~     recurrent disease despite receiving concurrent chemoradiotherapy. New agents and~     dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts~     for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase~     local control and thus reduce the recurrence rate and prolong survival. Positron emission~     tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone~     scan. More precise localization of tumors leads to more accurate definition of target~     volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of~     patients relapse and die within one and two year after therapy. Few patients survive longer~     than three years. Thus, two-year survival is considered a clinically highly relevant measure~     of efficacy.~      The aim of this study is to compare two schedules of TRT with respect to local control,~     progression free survival, overall survival, toxicity and health-related quality of life. In~     addition patients who have the best outcomes and tolerate chemoradiotherapy will be~     characterized (e.g. clinical characteristics, blood biomarkers, body composition).~   "
77585|NCT02041832|"~     Using implantable loop recorder the investigators wish to detect atrial fibrillation in high~     risk patients and compare it to the results using conventional Holter monitoring. The~     hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The~     investigators want to detect those people so they can receive appropriate anticoagulation~     treatment. The patients will get a comprehensive workup including ecg, echocardiography and~     blood tests.~   "
77586|NCT02041819|"~     Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR),has been shown to be effective and safe in some studies with head-neck~     cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety~     than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus~     nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The~     investigators then initiated a phase II clinical trial with Nimotuzumab plus~     Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced~     esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.~   "
77587|NCT02041806|"~     The purpose of this study is to determine if Peripheral Nerve Block scoring systems are~     effective in predicting the achievement of intra-operative anaesthesia and post-operative~     analgesia.~   "
77588|NCT02041793|"~     This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage~     for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure~     will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary~     outcomes will be complications, recurrence and cost analysis between the two methods.~   "
77589|NCT02041780|"~     The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or~     associated, are effective methods to assess liver fibrosis in children.~   "
77590|NCT02041767|"~     The purpose of this study is to demonstrate the prostatic diffusion in significant~     concentration of ertapenem achieved after a pre-operative single administration.~   "
77591|NCT02041754|"~     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several~     studies demonstrating their efficacy, we are conducting this study to look into the efficacy~     and safety of this novel combination of three fibres, in appetite regulation, aiming to~     reduce the appetite.~   "
77592|NCT02041741|"~     This study aims to assess the effects of two different types of interventions aimed at~     increasing happiness in the Flemish general population as compared to individuals that~     receive no intervention.~   "
77593|NCT02041728|"~     The investigators are going to test if it is possible to detect early dementia with the~     digital game memory. The investigators are going to test 15 healthy people and 15 patients~     with early dementia.~      The test consists of playing the game memory several times. While playing, several~     parameters are stored.~      The investigators are going to test if any correlation can be found between these parameters~     and the cognitive state of the person as tested by the Mini-Mental status examination.~   "
77594|NCT02041715|"~     Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending~     dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.~   "
77595|NCT02041702|"~     The aim of this study is to assess the safety and efficacy of the SJM MRI conditional pacing~     system in subjects undergoing Cardiac Magnetic Resonance Imaging.The study hypothesis is~     that cardiac MRI scan will not affect the performance of the SJM MRI conditional pacing~     system when special conditions are met. Comparing with the control group,freedom from MRI~     scan-related complications and the electronic performances such as pacing threshold,sensing~     amplitude should be similar.~   "
77731|NCT02039934|"~     High intensity interval training is applied for several diseases.~      Hypothesis: High intensity interval training improves insulin sensitivity in patients with~     type 2 diabetes.~   "
77596|NCT02041689|"~     Thousands of children are diagnosed with cancer each year, many of whom will achieve long~     term survival due to advances in treatments and technologies. However, when a child is first~     diagnosed, they are confronted with a wealth of new and unfamiliar medical information that~     they must integrate in order to understand their diagnosis and treatment plan. Little is yet~     known about how children with cancer experience learning about their diagnosis and treatment~     in the hospital setting, or the individuals and materials that may help to facilitate the~     child's developing understanding. This information could help to identify or guide~     educational and supportive child life interventions to help children with cancer better~     understand their illness and its treatment.~      This observational study will collect data about how children currently learn about their~     cancer diagnosis and treatment in the hospital setting. The interventions used do not seek~     to change the health outcomes of the participants in this study. The observational data~     collected may serve to improve how future patients learn about their cancer-related~     diagnosis.~   "
77597|NCT02041676|"~     The main objective is to show by a randomised controled therapeutic trial comparing in two~     parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the~     duration of non invasive respiratory support in the group treated by chest physiotherapy as~     compared to the control group. The secondary objectives are to evaluate the duration of~     oxygen dependence, the duration of hospitalisation and the proportional advent of~     bronchopulmonary dysplasia.~      These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic,~     treated by non invasive respiratory support after weaning off from mechanical endotracheal~     ventilation benefitting form a social security system and for whom the appropriate parental~     authority are non opposed.~   "
77598|NCT02041663|"~     Use of brain natriuretic peptide to evaluate the cardiac function in the course of~     meningococcal septic shock or severe sepsis.~   "
77599|NCT02041650|"~     This protocol describes a pilot study intended to test the hypothesis that patients with~     acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective~     antithrombotic treatment without stent implantation, thereby avoiding both early and late~     complications related to percutaneous coronary intervention (PCI).~   "
77600|NCT02041637|"~     The purpose of the study is to evaluate the outcome and to determine predictive factors of~     patients admitted in a context of acute liver failure without identified cause.~   "
77601|NCT02041624|"~     The purpose of the present study is to describe patient's perception of quality of life and~     effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.~   "
77602|NCT02041611|"~     The primary goal of this study is evaluate T cell immune status and immune reconstitution~     and the association with specific cytokines in patients with newly diagnosed HGGs undergoing~     the standard RT/TMZ and adjuvant TMZ.~   "
77603|NCT02041598|"~     The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community~     Health Worker (CHW) intervention to improve diabetic management and control among~     Bangladeshis with diabetes in New York City (NYC).~   "
77604|NCT02041585|"~     The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement~     Information System Study) is a study to see the effect of patients' social, physical and~     mental function on their health after hospital discharge.~   "
77605|NCT02041572|"~     The study has two goals. First to develop a computer-based intervention meant to alter~     cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test~     the intervention in a small sample of veterans for feasibility and acceptability.~   "
77606|NCT02041559|"~     Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid~     rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone~     reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal~     ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of~     remifentanil, it is associated with κ and δ receptors, which leads to renal protection~     effect in animal study. Also, remifentanil infusion during anesthesia showed a diuretic~     effect. The purpose of this study is to investigate the remifentanil effect on renal~     function during robot assisted prostatectomy.~   "
77607|NCT02041546|"~     Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in~     newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change~     the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or~     bolus poractant alfa changes the duration of mechanical respiratory support or other~     outcomes in MAS.~   "
77608|NCT02041533|"~     The purpose of this study is to show that Nivolumab will improve progression free survival~     in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when~     compared to chemotherapy~   "
77609|NCT02041520|"~     Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in~     the prevention of complications in seropositive for HIV patients. However, they develop some~     manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing~     cardiovascular risk.~      Clinical trials in general population and in patients on hemodialysis have demonstrated a~     significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are~     believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially~     triglycerides. Also in general populations it has been described a benefit effect of omega 3~     acids on oxidative stress.~      Objective: to know the effect of omega 3 acids on different markers of oxidative stress in~     seropositive HIV patients.~      Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV~     patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They~     will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or~     placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and~     stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid~     peroxidation products) will be evaluated.~      Sample size was calculated according to different variables. We selected the biggest one~     calculated for a difference in nitric oxide of 25% after treatment between groups and a~     standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size~     of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient~     lost, a sample size of 35 per group was considered.~   "
77732|NCT02039921|"~     The study aims to describe the changes of combination antiretroviral therapy and the causes~     that motivated them.~   "
77610|NCT02041507|"~     The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC)~     appears to be related to the quality of the procedure, and the incomplete removal of lesions~     has been shown to increase the subsequent risk of developing a colon cancer.~      Some studies suggest that small polyps with advanced histology are more common in the right~     than in the left colon (right colon proximal to splenic flexure, left colon distal to the~     splenic flexure). The average size of polyps in the right colon with advanced pathology or~     containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm,~     P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to~     right-sided polyps with advanced histology or that harbor malignancy. These presumptive~     precursors of cancer are smaller and possibly more easily obscured by residual feces, and~     more likely to be missed at colonoscopy.~      Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water~     immersion (WI), characterized by suction removal of the infused water predominantly during~     the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction~     removal of infused water predominantly during the insertion phase of colonoscopy.~      In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI)~     in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the~     proximal colon.~      In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis~     that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in~     CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE~     enhances the quality of screening colonoscopy.~      We also hypothesize that WE may be more effective in detecting proximal colon adenomas than~     WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal~     colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for~     further testing that WE may provide a strategy to improve prevention of colorectal cancer by~     increasing detection of adenomas in screening colonoscopy.~      Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases~     of colonoscopy will be done by different investigators. The second investigator will be~     blinded to the method used to insert the instrument, thus eliminating possible bias about~     procedure related issues.~      Several secondary outcomes will also be analysed.~   "
77611|NCT02041494|"~     Hernias are often treated using a prosthetic mesh to add support to the healing wound.~     Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data~     regarding which type of mesh to use is limited. The purpose of this study is to compare the~     effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin~     (called a biologic prosthetic), and one that is made in a laboratory (called a synthetic~     prosthetic). This study will include some patients who have an infection in/near the~     hernia, and other patients who do not have an infection. We expect the synthetic mesh to be~     associated with a higher rate of early post-operative surgical site infection and fluid~     collections (seromas), while we expect the biologic mesh to be associated with a higher rate~     of recurrence.~   "
77612|NCT02041481|"~     This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given~     together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with~     advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill~     more tumor cells.~   "
77613|NCT02041468|"~     This is a phase IV multicenter trial to evaluate the mechanisms of resistance and~     pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a~     real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.~      The study will address two anticipated issues surrounding personalized medicine and~     treatment with crizotinib:~        -  it will enable real-life Heath Economics and Outcome Research (HEOR)~        -  it will validate and/or identify new blood-based or tissue-based biomarkers of~          resistance to crizotinib.~      At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will~     be asked to complete quality-of-life questionnaires at regular intervals in a real-life~     setting of treatment with crizotinib.~      Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to~     understand resistance mechanisms of crizotinib. In these patients, a biopsy from any~     accessible metastatic lesion will be obtained when the patient is no longer responding to~     treatment, as well as blood sampling during regular treatment visits.~   "
77614|NCT02041455|"~     Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse~     musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and~     headache are also commonly associated with the syndrome .~      Although the etiology of this syndrome is not well defined yet, it means involve multiple~     mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid~     and altered circadian variation in sympathetic - parasympathetic balance, consistent with~     changes in sympathetic hyperactivity at night .~      The immune - pineal system, formed by the integration of the adrenergic and immune systems~     pineal gland, appears to be involved in the genesis of the dysfunctions found in~     fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep.~     Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in~     patients with fibromyalgia.~      The present study aims to evaluate the relationship of immune - pineal system in the process~     of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that~     participate in the pathophysiological process of this disease.~   "
77615|NCT02041442|"~     The hypothesis is that the intrinsic electrical activity of the urinary bladder in response~     to filling is detectable and can be mapped. This is a pilot study to evaluate the~     feasibility of using cardiac electrical mapping catheters to measure bladder voltage in~     patients at the time of routine urodynamic and cystoscopic evaluation.~   "
77616|NCT02041429|"~     This phase I/II research study is evaluating a combination of drugs called paclitaxel and~     ruxolitinib as a possible treatment for inflammatory breast cancer. Ruxolitinib is a newly~     discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway)~     that may be important in cancer, including breast cancer. Blocking this pathway may stop~     cancer cells from growing. Ruxolitinib has been approved by the FDA for patients with bone~     marrow disease, and this is the first study using this drug in combination with paclitaxel~     for breast cancer. Paclitaxel (also called Taxol) is an FDA drug approved for breast cancer~     patients. Paclitaxel works by blocking the small microtubules inside cancer cells and~     preventing cell growth. Information from laboratory experiments suggests that ruxolitinib~     might also have effects on breast cancer.These studies have shown that ruxolitinib may make~     paclitaxel more effective.~   "
77617|NCT02041416|"~     The goal of this study is to determine the feasibility, reliability, and validity of~     administering the Geriatric Assessment Tool using these two different computer based survey~     platforms, REDCap and Support Screen. The development of a computer based Geriatric~     Assessment Tool has the potential to improve research and clinical practice by providing an~     efficient user friendly means to collect and analyze data for geriatric oncology patients.~   "
77619|NCT02041390|"~     Endoscopic implantation of plastic or covered metal stents is widely used in a variety of~     benign pancreaticobiliary diseases, including duct stricture, large or difficult stones,~     bile or pancreatic juice leak, etc. There are some late-stage adverse events after stent~     insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and~     failure of stent removal, etc. The longer the stents were inserted, more likely the adverse~     events would happen.~      Although the optimal time of stent placement has not been well established, it has been~     recommended that plastic stent should be removed/exchanged within 3-4 months and covered~     metal stent be removed within 6 months. However, it was not uncommon that patients with~     stent implantation did not follow the recommendation of further stent management by~     endoscopists.~      Many methods have been used to improve the adherence of patients in medical service. With~     the advance of mobile technology and popular use of mobile phones, it was believed that the~     patient-centered outcome could be improved by mobile telecommunication with the timely~     support of a patient by a health professional. Thus we hypothesize that mobile technology,~     reminding the patients the necessity of stent management in time by short message service~     (SMS), might increase the patient adherence in patients with benign pancreaticobiliary~     diseases after ERCP.~   "
77620|NCT02041377|"~     The purpose of this study was to determine if subjects who have diabetes can operate the~     Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid~     glucose results.~   "
77621|NCT02041364|"~     Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand~     the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective~     study with breast cancer patients receiving adjuvant chemotherapy.~   "
77622|NCT02041351|"~     There is clinical benefit of docetaxel administered to patients who have progressed to 3 or~     more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using~     docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic~     responses are obtained that it never received taxanes.~   "
77623|NCT02041338|"~     There are no standard neodjuvant regimens adapted according to the different subtypes of~     breast cancer. This is a phase 2, randomized study to evaluate several regimens in different~     subtypes of breast cancer.~   "
77624|NCT02041325|"~     This is a research study to determine if the study drug lenalidomide will increase the~     body's immune response, which is the body's response against infections or tumors, to~     hepatitis B vaccine in patients with plasma cell diseases which include multiple myeloma,~     monoclonal gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It~     is not a study to see if lenalidomide is an effective treatment for plasma cell disease.~      Participants in this study have multiple myeloma or other plasma cell disease and have never~     been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to~     alter the immune system and thereby increase immune response. It also has some effect~     against cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer~     cells.~      In this study, one-half of the subjects will be chosen at random to receive the study drug~     and the other half will take a placebo pill (a sugar pill that looks the same as the real~     medication). This is a double blind study where neither the subjects nor the investigators~     know whether the patient receives the study drugs or placebo pills. The effects of the~     active drug lenalidomide will be compared to the effects of the placebo. The results from~     this study will be also be compared with a similar but separate study to be done on~     individuals without known disease.~      This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare~     System and the Dana Farber Cancer Institute.~   "
77625|NCT02041312|"~     Investigators have a plan to conduct nested case-control study to investigate the~     association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG),~     apolipoproteins and gastric neoplasm. In addition, further analyses were performed to~     evaluate the possible role of the serum cholesterol as a predictor for the differentiation~     and prognosis of gastric neoplasm.~   "
77626|NCT02041299|"~     This research is being done so that we can look at the safety and efficacy of deferiprone in~     people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron~     from the body. We will be comparing deferiprone with deferoxamine, another drug that removes~     iron from the body.~   "
77627|NCT02041286|"~     The purpose of this study is to determine if subjects who have diabetes can operate the~     Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid~     glucose results.~   "
77628|NCT02041273|"~     A relative bioavailability study of commercial palbociclib free base hard capsules to the~     isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different~     fasting conditions.~   "
77629|NCT02041260|"~     Phase II, non-randomized, open-label study to determine the efficacy of cabozantinib as a~     firstline treatment for patients with differentiated thyroid cancer (DTC). Subjects will~     receive drug at a starting dose of 60mg PO QD. Subjects can receive drug as long as they~     continue to derive clinical benefit or until they experience unacceptable drug-related~     toxicity.~   "
77630|NCT02041247|"~     The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV~     patients receiving standard of care antiretroviral treatment.~   "
77631|NCT02041234|"~     Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical~     treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with~     type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce~     resource utilization in the near term with similar projected reduction over the medium to~     long term.~   "
77632|NCT02041221|"~     Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound~     SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending~     doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.~   "
77633|NCT02041208|"~     The purpose of this study es to determine hemoglobin variability in kidney transplant~     recipients with chronic renal anemia.~   "
77965|NCT02036892|"~     Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching +~     smartphone-based health promotion software) will have significantly better Hemoglobin A1c~     levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the~     control arm (health coaching alone).~   "
77635|NCT02041182|"~     Pediatricians are supposed to talk about youth violence at all heath supervision visits,~     however these types of conversations rarely occur. There have been no studies assessing~     tools to prompt these discussions. The goal of this study is to see if electronic pre-visit~     questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the~     primary care setting. Additionally, patient-provider characteristics are explored as~     mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ~     by patients and providers.~      Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals~     will be recruited. A baseline phase was conducted to look at how often providers ask about~     health-related teen behaviors, assessed by exit survey. The experimental period will involve~     adolescents completing health-related behavior PVQ, given to their doctor prior to the~     visit. Exit survey will assess topics discussed. Experimental group will differ from control~     group based on PVQ containing extra questions about youth violence.~   "
77636|NCT02041169|"~     Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease.~     Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is~     primarily caused by atherosclerosis that induces an inadequate blood flow to meet the~     tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions~     in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their~     walking capacity, contributing to an impairment of their quality of life. Despite~     maintaining a sufficient walking activity is essential for these patients, LEPAD patients~     lower their physical activity, which worsen the disease and potentially contribute to~     increase the risk of cardiovascular events and deaths.~      In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high~     variability of the patients' walking capacity (i.e., walking distances between two stops~     induced by lower limbs pain). Results suggested that in most patients previous stop duration~     before each walk was a predictor parameter of this walking variability. Whether there is an~     optimal or minimal recovery time influencing the walking capacity in LEPAD patients has~     never been studied.~      This study is a prospective, cross-sectional study in exercise pathophysiology.~      The main goal is to determine, following a walk that induces ischemia, the influence of the~     recovery duration on the subsequent walking performance in LEPAD patients.~      Secondary goals are :~        1. To determine the nature of the relationship between the recovery duration and~          subsequent walking performance.~        2. To study the relationship between exercise ischemia, pain evolution and previous~          recovery duration.~        3. To determine whether the experimental procedure influence the determination of an~          optimal of minimal recovery duration.~        4. To study the influence of recovery duration on walking capacity from community-based~          measurement.~      It is expected to determine for the first time an optimal recovery duration that would~     maximize the walking capacity of LEPAD patients.~      In the medium term :~        -  To give indications to the LEPAD patients to manage their pain in the community without~          lower their physical activity.~        -  To limit the functional decline of LEPAD patients.~        -  To influence the quality of life and cardiovascular mortality. This would deserve~          furthers studies.~   "
77637|NCT02041156|"~     The investigators' purpose is to study which exercise training modality: aerobic physical~     activity in conjunction with either resistance training or balance training, is most~     beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]).~     Furthermore, our purpose is to evaluate the long-term effects of exercise training on~     functional status, cardiovascular morbidity, blood pressure control, heart rate variability,~     cardiac function, inflammation, body composition, nutritional status, progression of uraemia~     and health related quality of life. This interventional study is prospective, randomized and~     controlled comprising 150 prevalent and incident patients from our outpatient clinic.~     Patients are invited to participate in the study consecutively, irrespective of basic~     functional status. At start patients are randomised either to resistance or balance training~     and the programme is adapted and individualised to each patient's actual physical status and~     ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping~     the intensity constant at a level of somewhat strenuous to strenuous on the Borg scale~     rate of perceived exertion. The total observation period is 12 months with checks every four~     months. Although exercise training is a recommended therapy in CKD, there is a lack of~     medical and scientific evidence on optimal prescription. We hope that this study will~     provide evidence-based knowledge on exercise prescription and its effects on various risk~     factors in CKD patients. Finally, if patients achieve a higher degree of physical functional~     capacity they should be able to maintain an autonomous lifestyle, resulting in considerable~     reductions in societal costs for care and transportation.~   "
77638|NCT02041143|"~     This trial is an exploratory study in order to determine whether the ingestion of one type~     of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in~     the extension of the post-prandial window of anabolism during the night by increasing whole~     body protein balance as well as muscle protein fractional synthesis rate (FSR).~   "
77639|NCT02041130|"~     Investigators will test a new approach to a form of heart failure (HF) with no current~     treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have~     preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These~     stiff hearts pump strongly but fill inefficiently resulting in poor exercise capacity and~     high death rates. Treatments that help when heart pumping action is poor are of no benefit~     in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the~     kidneys (renal denervation; RDN) has been able to reduce BP in patients with high BP~     resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys,~     heart and circulation this treatment has promise in HF. The investigators will compare~     effects of RDN and standard medical treatment on heart function, exercise capacity and~     quality of life in 144 patients with HFPEF~   "
77640|NCT02041117|"~     1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of~          Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing~          LDL-C level to or less than 70mg/dl.~        2. Ischemic stroke patients will be enrolled within 1 month after stroke onset.~        3. Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.~   "
77641|NCT02041104|"~     The purpose of this study is to investigate if daily consumption of barley beta-glucans~     impact on lipid and glucose metabolism and on intestinal microbiota in a population with~     metabolic syndrome. It is assumed that two month intervention with beta-glucans will improve~     some clinical signs of metabolic syndrome and alter composition of intestinal microbiota.~     Variation in microbiota composition will be investigated with emphasis on Bacteroidetes and~     Firmicutes ratio. Furthermore it is presupposed that consumption of beta-glucans will~     stimulate growth of beneficial intestinal bacteria from genus Lactobacillus and~     Bifidobacteria and consequently effect production of short chain fatty acids in population~     with metabolic syndrome. Moreover it is presupposed that two-month consumption of~     beta-glucans will have influence on glucose metabolism and will consequently improve insulin~     resistance within people with metabolic syndrome. It is assumed that two-month consumption~     of beta-glucans will improve specific plasma lipid content in population with metabolic~     syndrome.~   "
89014|NCT01892137|"~     The main purpose of this trial is to demonstrate the predictive value of the clinical~     diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using~     histopathological examination as the standard.~   "
77646|NCT02041039|"~     Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption~     also stimulates appetite, and contributes to overeating while under alcohol's acute effects.~     Knowing the brain regions that respond to food aromas and alcohol, and how they are modified~     by the amount of body fat and alcohol exposure, will provide critical information about the~     neural systems that underlie loss of control of eating. Therefore, the main hypotheses of~     this study are that: A) Lean and obese subjects have different brain responses to food~     aromas that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's~     response to food odors, and ii) affects brain systems that inhibit or terminate eating. To~     test these hypotheses, we have modified functional magnetic resonance imaging (fMRI)~     paradigms successfully used to study alcoholic drink aromas in subjects at risk for~     alcoholism.~   "
77647|NCT02041026|"~     We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and~     subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood~     respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated~     from fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of~     aflatoxin available in our invitro texts.~   "
77648|NCT02041013|"~     The research goal is to explore the use and effects of a custom-recordable audio discharge~     instruction card (Talking Card) in the pediatric health care setting. This study will~     address a primary, experimental research question: can pediatric asthma control be improved~     through the distribution of a custom-recorded audio asthma instruction card to parents at~     the health provider's office? Secondary, descriptive objectives will be to evaluate~     feasibility of Talking Card delivery and to collect and summarize parental reactions to the~     design and use of the audio discharge instruction card.~      The specific aims of this study are:~        1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children~          aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma~          instruction card to the change in mean C-ACT scores for those receiving usual care.~        2. To measure the use and impressions of a custom-recordable audio asthma discharge~          instruction card among primary caregivers of children with uncontrolled asthma through~          quantitative and qualitative survey questions.~      The investigators hypothesize that:~      1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as~     measured by the C-ACT, will improve to a greater extent among those receiving a~     custom-recordable audio discharge instruction card than among those receiving usual care.~   "
77649|NCT02041000|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed with chronic obstructive pulmonary disease (COPD).~   "
77650|NCT02040987|"~     A thorough QT study of AZD3293~   "
77651|NCT02040974|"~     Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the~     symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on~     quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic~     rhinitis patients sensitized to different allergens. Also the development of new~     sensitizations and asthma during the immunotherapy were determined.~   "
77652|NCT02040961|"~     The double tube ETView is particularly innovative as it includes an integrated optical fiber~     to visualize the carena. This study aims to verify if if its use avoids the requirement of a~     fibreoptic bronchoscopy.~   "
77653|NCT02040948|"~     The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7~     device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of~     stroke volume (esophageal Doppler) to detect the response to a fluid challenge.~   "
77654|NCT02040935|"~     This single-arm, open-label, local multicenter study will evaluate the safety and~     tolerability of Herceptin (trastuzumab) administered subcutaneously by a single-use~     injection device (SID) in patients with HER2-positive early breast cancer. Following surgery~     (and neo-adjuvant or adjuvant chemotherapy), patients will receive Herceptin 600 mg~     subcutaneously by SID every 3 weeks for a total of 1 year, unless disease recurrence or~     unacceptable toxicity occurs. After the first 3 cycles, patients will be permitted to~     self-administer Herceptin under supervision of a HCP.~   "
77655|NCT02040922|"~     The principal research objective is to determine the impact of antibiotic use on the risk of~     developing long term bowel symptoms after infection with the germ Campylobacter.~   "
77656|NCT02040909|"~     Newborns admitted to an intensive care unit often require artificial ventilation. For that~     purpose an endotracheal tube needs to be placed into the trachea, a procedure named~     endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop~     moving and to relax in order to enable the success of the procedure. For this sedation an~     anesthetic agent named propofol is often used. The used dose of propofol has not been~     properly studied and as a consequence patients are under- or over -sedated and propofol~     leads to side effects such as hypotension.~      The current study aims to find the most appropriate dose of propofol for newborns of~     different gestational ages and of different post-natal ages. We will use propofol in~     different doses and after each 5 included patients per age group we will analyze whether the~     dose needs to be increased or decreased. The effect of the propofol will be extensively~     monitored and we will study the level of sedation, the quality of intubation, the stability~     of the patient en the occurrence of side effects.~      At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.~   "
77657|NCT02040896|"~     The primary objectives are:~        1. To investigate which healthcare workers and other individuals contribute to the~          decision to order computed tomography (CT) scans for emergency department (ED)~          patients.~        2. To investigate the specific reasons healthcare workers and other individuals order or~          request CT scans for ED patients.~        3. To determine the frequency of clinically important actions following CT scan results.~      Once the drivers of ED CT utilization are identified, interventions including education,~     incentives for compliance with evidence-based best practices, and interventions for~     noncompliance could be targeted appropriately.~   "
77658|NCT02040883|"~     Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve~     Cognitive function in Schizophrenia~   "
80349|NCT02005718|"~     Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial~     dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated~     the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.~   "
77659|NCT02040870|"~     A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics,~     safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with~     locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must~     have demonstrated progression during or after crizotinib treatment whether or not previously~     treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the~     first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in~     period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult~     patients with ALK-rearranged NSCLC will be evaluated.~   "
77660|NCT02040857|"~     This research study is evaluating a drug called Palbociclib in combination with endocrine~     therapy as a possible treatment for hormone receptor positive breast cancer.~        -  Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks~          activity of two closely related enzymes (proteins that help chemical reactions in the~          body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a~          pathway, or a sequence of steps which is known to regulate cell growth. Laboratory~          testing has suggested palbociclib may stop the growth of hormone receptor positive~          breast cancer.~        -  Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation.~          During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor.~          It is standard of care for premenopausal women to take tamoxifen and for postmenopausal~          women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone~          receptor positive breast cancer.~   "
77661|NCT02040844|"~     The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD~     in cat allergic subjects for up to five years after the start of administration of~     treatment. The study is an optional follow-up study to a phase III double-blind, placebo~     controlled, Cat-PAD study; no further investigational product is administered.~   "
77662|NCT02040831|"~     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children~     around the world. This study will evaluate the safety and immune response to an RSV vaccine~     in RSV-seronegative infants and children.~      This study is a companion study to IMPAACT 2000.~   "
77663|NCT02040818|"~     Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream~     infections that arise from the catheter. There are several management options for treatment~     of such an infection, though the best option is not clearly delineated. Standard of care~     options include exchanging the catheter for a new one over a guide-wire and instilling a~     high concentration of an antibiotic directly into the catheter lumen. The investigators are~     planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1.~     Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new~     one. Both these options have comparable cure rates as shown in the medical literature. After~     obtaining informed consent, patients will be randomized to either treatment arm and will~     continue to receive all other standard medical care.~      Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel~     antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is~     non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related~     bacteremia.~   "
77664|NCT02040805|"~     This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common~     and impairing neuropsychiatric syndrome that has a profound impact on the lives and~     functioning of individuals, families, and society. Specifically, we will compare a novel~     community-based group treatment led by individuals from the community who are not mental~     health professionals to the current standard of care treatment for Hoarding Disorder,~     cognitive behavioral therapy, conducted by psychologists in a group setting. We hypothesized~     that both treatment types will be similarly effective in reducing hoarding severity.~   "
77665|NCT02040792|"~     This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product~     when administered once daily for 28 days using a jet nebulizer to patients with moderate to~     severe chronic obstructive pulmonary disease.~   "
77666|NCT02040779|"~     This is a randomized, double-blind, placebo-controlled parallel-group study. Participants~     will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage~     of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI~     placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and~     investigators will remain blinded to randomized treatment assignment during the study.~      The study consists of 3 periods:~        -  run-in period: Screening visit (SV) to randomization visit (RV), 14-21 days (2-3 weeks)~          prior to study start~        -  double-blind treatment period: RV through the final treatment visit, 85±3 days or 12~          weeks after study start.~        -  follow-up period: a follow-up visit/telephone call, 7±3 days after the treatment period~          ends.~   "
77667|NCT02040766|"~     This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week~     study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160~     mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in~     pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo.~   "
77668|NCT02040753|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One~     approach to achieve weight loss and change life style is to participate in an intensive~     supervised prolonged life style modification course. The immediate effect is often positive,~     but over time the overall effect is limited as the majority will not maintain weight loss~     and a changed life style.~      In this study we will analyse the results of the intensive lifestyle intervention as it has~     been practised at Ubberup Folk High School over the last 13 years. As some people have~     several stays at Ubberup Folk High School we want to we have a special interest in the~     effect of repeated lifestyle intervention.~      Research question:~      What is the effect of several lifestyle interventions on weight loss maintenance?~      The study design is retrospective and descriptive and will be based on a lifestyle~     intervention, as it has practiced in a real life setting at Ubberup folk high school.~   "
77870|NCT02038127|"~     Comparison of~        -  Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore~        -  Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott,~          USA~        -  Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent~          Medtronic, USA in patients with coronary artery disease treated with percutaneous~          coronary intervention~   "
77669|NCT02040740|"~     An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23~     (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children~     are scarce. Currently it is assumed that meeting mineral requirements for the skeleton~     serves the body's overall needs. However, it is not clear as to whether this is true,~     particularly with growth. The contribution of dietary factors directly linked with the~     bone/kidney axis through measurement of intake (via 24hr recall) and kidney nutrient~     clearance (via serum and urinary analysis) will be included in investigations. Findings will~     serve as a springboard for delineating more specific mechanisms by which these systems~     become disordered and are influenced by diet. It is expected that adequacy of nutrients~     known to have a central role in bone function will optimize the hormonal milieu through~     crosstalk with the kidney.~      This effort will allow ongoing investigation in detecting and treating disturbances in~     mineral metabolism related to kidney disease, specifically in the pediatric population and~     broaden the understanding of kidney disease itself, as well as that of chronic diseases in~     which kidney health is of importance, such as diabetes and osteoporosis. Findings of this~     research may stress the importance of achieving dietary adequacy essential for establishing~     optimal body composition trajectories, particularly puberty.~   "
77670|NCT02040727|"~     This project will evaluate the impact of resistance training on the synthesis and release of~     hormones and growth factors from the musculoskeletal system and the extent to which the~     communicative capacity influences glucose homeostasis In turn, the contribution of glucose~     regulation on the musculoskeletal system will also be evaluated. This small study will serve~     as a pilot/feasibility study to define a protocol for implementation of a resistance~     training intervention in the pediatric population. To establish feasibility, this study~     population is limited to overweight African American boys ages 7-11 years.~      In light of well-established accolades of resistance training, historical recommendations~     for avoidance among the pediatric population have deterred implementation of resistance~     training interventions in young adolescents. However, contemporary data indicating a~     profound benefit of resistance training to the skeletal system in pre-adolescents has led to~     the Academy of Sports Medicine, as well as various other pediatric health interest groups,~     to support supervised programs incorporating resistance training in young children,~     emphasizing large muscle and core strengthening. To date, such trials have not been~     conducted in the pediatric population~   "
77671|NCT02040714|"~     Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a~     significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon~     enough to have a sufficient number of patients from a single institution to perform a~     definitive prospective study comparing the results of current treatments. The present study~     will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP)~     Disease and collect information regarding their presentation, treatment, and outcomes in the~     course of receiving currently available treatments.~      This study seeks to compare the outcomes of current treatments in the management of three~     age groups (ages 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year~     followup. For each age group, two to three common treatment regimens currently used by~     practicing pediatric orthopaedic surgeons will be compared. The intervention a patient~     receives is determined through physician preference. Physicians pick an intervention for~     each age group and treat each patient with the same intervention.~   "
77672|NCT02040701|"~     The purpose of the study is to measure markers of inflammatory and oxidative stress known to~     be associated with cardiovascular morbidity in snoring children.~      In addition, to measure markers of local inflammation and to evaluate the response to~     treatment.~   "
77673|NCT02040688|"~     Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36~     months of age. If left untreated, bedtime problems and night wakings can negatively impact~     the daytime functioning and behavior of the child, as well as the entire family.~      Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from~     children with physiological difficulties in ingesting food, through picky eaters to full~     fledged infantile feeding disorders.~      We have recently shown that feeding and eating difficulties are more prevalent among~     children with behavioral insomnia of childhood and that sleep problems are more frequent in~     children with feeding disorders.~      We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that~     children with sleep or feeding disorder have increased rate of Sensory intergration disorder~     (SID) compared with healthy controls.~   "
77674|NCT02040675|"~     The purpose of this study is to validate a novel method of diagnosing arrhythmias using the~     NAVA catheter-positioning screen in patients who have a NAVA catheter in place.~   "
77675|NCT02040662|"~     Thoracic surgery correlates with significant pain in postoperative period. In order to~     alleviate the pain various combinations of pharmaceuticals and administration methods are~     employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain~     various operation techniques are used. In traditional thoracotomy epidural anesthesia~     remains a golden standard. Epidural anesthesia however demands high skills to be performed~     correctly and presents an increased risk of grave complications. In videothoracoscopic~     (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its~     efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel~     group, single site study to test the hypothesis, that continuous paravertebral blockade is~     as efficient in postoperative pain reduction as continuous epidural blockade and possesses a~     higher safety profile.~   "
77676|NCT02040649|"~     Through many years, the standard care has been to use continuous sedation of critically ill~     patients during mechanical ventilation. However, preliminary randomised clinical trials~     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA~     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,~     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway~     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical~     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at~     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation~     on posttraumatic stress disorder after discharge from ICU.~      Our hypothesis is that critically ill patients who are not sedated during mechanical~     ventilation will have less posttraumatic stress disorder after discharge.~   "
89015|NCT01892124|"~     American Indians (AIs) living in the Northwest have very high rates of diabetes, obesity,~     tobacco use, depression, and other risk factors associated with cardiovascular disease.~     Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study~     seeks to build upon the success of the 1-month, 5-session motivational interviewing (MI) CVD~     prevention component of the həli?dxw Project (aka Healthy Hearts-originally funded under~     RFA-HL-06-002; U01 HL HL087322-05). həli?dxw successfully culturally adapted MI for CVD~     prevention for AIs, trained AIs to implement the intervention, and conducted a preliminary~     feasibility and efficacy trial. Initial results indicated that participants enthusiastically~     embraced the MI component of the program; however, observations of the counselors, survey~     data, and feedback from participants suggest that depressive symptomatology served as a~     barrier to achieving CVD preventive behaviors and desired outcomes; and, that more time and~     attention to underlying depressive symptomatology may enhance motivation and CVD prevention~     behaviors, particularly among AIs with pre-diabetes and Type 2 diabetes. Building upon solid~     preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing~     an MI approach, and motivated by the need to address elevated depression and diabetes~     profiles from the həli?dxw study, the investigators will develop a 3-month, 10-session~     MI-based cognitive-behavioral-adherence (MI-CBT-CVD) treatment program to address underlying~     depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk~     behaviors among 50 pre-and recently diagnosed diabetic AIs at risk for CVD. The study~     proposes three innovative and significant aims. First, in line with community-based~     participatory (CBPR) principles and pre-established indigenous research protocols with the~     tribal community, the investigators will conduct formative research to develop the~     MI-CBT-CVD intervention. Second, the investigators will conduct a pilot randomized~     two-group, single-site waitlist-controlled clinical trial of a 10-session, 3-month MI-based~     cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently~     diagnosed diabetic AI adults with depressive symptomatology and who are also at risk for~     CVD. Assessments will be conducted at pre and post intervention and at 6-months (3 month~     follow-up). Third, the investigators will disseminate the findings to the tribe as well as~     research outlets and prepare an RO1 to conduct a full-scale RCT should the pilot~     intervention be efficacious, acceptable to the community, and feasible. The primary~     objectives will be to determine the effect of the proposed culturally-grounded behavioral~     intervention program on (a) reducing weight as measured by BMI (7-10% reduction in BMI); (b)~     decreasing depressive symptomatology; (c) increasing physical activity; (d) decreasing~     sedentary activities; (d) increasing healthful food habits; and (e) improving biomedical~     outcomes (e.g., blood lipid profiles, glucose, hemoglobin A1C, and blood pressure). The~     intervention will be culturally relevant and utilize existing Native resources and personnel~     wherever possible.~   "
77677|NCT02040636|"~     Primary objective:~        -  To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed~          combined with component pertussis and inactivated poliomyelitis vaccine grown on vero~          cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with~          component pertussis and inactivated poliomyelitis vaccine grown on vero cells~          (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years~          of age.~      Secondary objective:~        -  To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at~          11-14 years of age results in detectable immunologic interactions between components of~          the two vaccines.~   "
77678|NCT02040623|"~     -  To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to~          subjects evaluated by objective and subjective measures.~        -  To investigate the safety and tolerability of R348 Ophthalmic Solutions administered~          for 12 weeks to subjects.~   "
77679|NCT02040610|"~     This study is being proposed to evaluate the use of moderate hypofractionated proton therapy~     in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as~     gastrointestinal and genitourinary early and late toxicities will be analyzed and compared~     to conventional proton therapy regimens. It is thought that this regimen will produce~     comparable findings and would result in substantial health care cost savings, as well as, be~     more convenient for patients.~   "
77680|NCT02040597|"~     The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after~     single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with~     different level of renal impairment in comparison with matching healthy volunteers.~     Moreover, the safety and tolerability of the study drug will be also evaluated.~   "
77681|NCT02040584|"~     Assuming greater efficacy in the prevention of acute rejection in the EVR arm with~     minimisation of TAC levels, the hypothesis of the present trial is that the introduction of~     EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function~     compared with standard therapy with TAC-MMF.~   "
77682|NCT02040571|"~     The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed~     Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available~     technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1~     Diabetes.~   "
77683|NCT02040558|"~     This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with~     advanced solid malignancies who have failed conventional therapy. The safety, tolerability,~     pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of~     MNK-010 will be evaluated in subjects with advanced solid tumors.~   "
77684|NCT02040545|"~     This study aims to determine the performance of a salivary hormone competitive immunoassay~     for monitoring patients during treatment for infertility.~   "
77685|NCT02040532|"~     The broad goal of this study is to obtain pilot data to determine the tolerability and~     preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and~     nighttime Vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose~     and only at night in peri- and postmenopausal women. We hypothesize that the majority of~     participants will be able to increase and tolerate treatment, and insomnia symptoms and the~     frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.~   "
77686|NCT02040519|"~     Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive~     bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to~     conservative treatment. Success rates range from 70 to 80%, and good long-term results are~     reported. The working mechanism of SNM is not completely understood, and the only prognostic~     factor for good response to this treatment is a successful test stimulation period. There is~     no consensus on the duration of this test stimulation period. The experience in our clinic~     during test stimulation period is that for responders it takes up to one week to achieve~     maximal effect, after the system is turned 'on'. On the other hand the investigators notice~     that after turning the neuromodulation system 'off', it will take a few hours for symptoms~     to return to the baseline situation. The fact is: no information concerning the so called~     time of onset and time of offset (or popular called: wash-in / wash-out) of sacral~     neuromodulation is available in current literature.~   "
77687|NCT02040506|"~     This study will examine the safety and tolerability of IGN523 administered as an IV~     infusion. The main purpose of the study is to determine the maximum tolerated dose (MTD),~     which is the highest dose that does not cause unacceptable side effects of IGN523 in~     patients with acute myeloid leukemia (AML). The MTD will be determined by observing the~     dose-limiting toxicities (the side effects that prevent further increases in dose) of~     IGN523. In addition, the pharmacokinetic profile and anti-leukemia activity of IGN523 will~     be assessed. A recommended Phase 2 dose (RP2D) of IGN523 will be identified, on the basis of~     safety, pharmacokinetic (PK), and pharmacodynamic (PD) data.~   "
77688|NCT02040493|"~     This is a physician sponsored multi-center, non-randomized, prospectively enrolling data~     collection study of patients with early stage breast cancer treated with electronic~     brachytherapy at the time of surgical resection of the cancer in the operating room. The~     radiation therapy treatments will be administered with electronic brachytherapy using the~     FDA cleared Xoft Axxent System.~   "
77689|NCT02040480|"~     This study is being conducted to measure the relative bioavailability of the original~     gelatin capsule formulation and a new formulation, immediate release (IR) tablet of~     Afuresertib (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up~     Periods. A subject's total time involved in the study will be approximately 9 weeks. The~     study will enroll approximately 18 healthy volunteers.~   "
77690|NCT02040467|"~     The goal is to collect information on each patient treated with proton beam radiation~     therapy.~   "
77739|NCT02039830|"~     The recommended treatment for urinary incontinence (UI) in women is individualised pelvic~     floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently~     unable to meet. This non-inferiority randomized control trial seeks to determine if~     group-based PFM training is as effective as individualised PFM training for treating UI in~     women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that~     group-based treatment is at least as good as individualised one-on-one treatment and more~     cost-effective would warrant including group-based PFM training as a first-line UI~     treatment.~   "
77691|NCT02040454|"~     The objective of this study is to evaluate the safety and effectiveness of the use of~     intravascular paclitaxel, in addition to standard therapy, for the treatment of~     arteriovenous dialysis access fistula stenosis.~      A fistulogram will be performed in standard fashion. The diagnostic component will include~     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or~     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and~     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur~     at this point.~      All patients will then receive standard therapy for their stenosis. This will include~     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond~     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)~     will be stented. Stent selection will be based on clinical setting. Initial stent treatment~     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include~     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).~     Documentation of location and type of treatment for each lesion treated will be recorded.~      Once standard treatment is completed, the operating surgeon will be informed of the results~     of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the~     whole fistula vein outflow segment of the fistula will be treated with paclitaxel.~      The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be~     treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will~     be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until~     the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter~     and length of the vessels treated. Maximization of the length of vessel and lesions treated~     will be undertaken when there are more lesions than can be accommodated by the 12 mg, 10 ml~     dose available.~      A 5 F sheath, 20 cm in length, will be used to administer the paclitaxel. This will be~     advanced from its distal position in the radial artery over the guidewire so that the tip of~     the sheath is in the proximal radial artery.~      Prior to removal of the sheath, a final angiographic study of all areas treated is performed~     to document patency and lesion appearance. Any additional lesions identified with this study~     are then treated appropriately following standard technique.~      For the control group, instead of paclitaxel administration, a sham treatment period of 10~     minutes is allowed to elapse followed by the performance of the final completion angiogram.~     Any additional lesions identified with this study are then treated appropriately following~     standard technique.~      All patients will follow the same follow up evaluation schedule~   "
77692|NCT02040441|"~     This is a prospective, multicenter, randomized, double blind, placebo-controlled and a~     prospective observational study.~      This study will be conducted at 13 study centers in various European countries.~     Approximately 3500 participant between 18 to 75 years old with Type 2 diabetes mellitus and~     normoalbuminuria will participate in the study. The study period is 3 years (excluding the 6~     week screening period). Depending on the risk score of the urinary protein pattern,~     participants will be stratified into an observational group or an interventional group.~     Either 5 (low risk pattern, observational group) or 15 (high risk pattern, interventional~     group) office visits of 1-3 hours duration are scheduled.~      The interventional group will be allocated into one treatment group either receiving~     spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The~     allocation to one of the two treatment groups will be done by a random distribution~     procedure established before the study start.~      The results of the urine sample from the Screening visit has been analysed and the urine~     proteomic pattern is determined to be either low- or high risk pattern and will determine~     the further study program.~      Participants with a low-risk pattern (observational group) (approximately 80%):~      During the next three years, participants will attend an annual project visit, were regular~     diabetes care will be performed and three urine samples will be analysed for albuminuria.~      Participants with a high-risk pattern (intervention group) (approximately 20%):~      Participants with a high-risk pattern will be randomization to either spironolactone~     treatment or placebo. The treatment is one tablet for oral use to be ta en once a day for~     the next three years. Four times each year (every 13th week) a study visit will be conducted~     including examination of three urine samples for albuminuria.~      This study aims to:~        1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that~          the urinary proteome test identifies patients with a high risk for development of~          microalbuminuria.~        2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in~          high-risk patients can reduce progression to microalbuminuria in comparison to placebo,~          on the top of standard treatment in a randomized double-blind, placebo-controlled~          multicenter study.~   "
77693|NCT02040428|"~     The objective of this study is to evaluate the safety and effectiveness of the EVARREST™~     Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.~   "
77694|NCT02040415|"~     The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to~     eperisone HCl in efficacy and safety.~   "
77695|NCT02040402|"~     Pneumonia is one of the most prevalent diseases in infants and children. The incidence of~     pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and~     America and more than 2 million children die of pneumonia annually. It was reported that~     Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in~     different age group of infants or children. In addition, 7%-9% of bacterial meningitis was~     due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus~     pneumoniae often transmit the pathogens to adult. As a result, it is evident that~     Streptococcus pneumoniae presents a heavy burden to paediatrics practice.~      Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing~     Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive~     pneumococcal disease in children. The impact of the vaccine was noted within 1 year of~     introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core~     Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years~     dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80~     to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended~     the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules.~     In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month)~     plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that~     two doses may provide similar direct protection to three conjugate doses during infancy, it~     is recommended to give two doses during infancy plus a booster dose 12 months in some~     European countries including United Kingdom.~      In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent~     pneumococcal conjugated vaccine in young infants will be compared.~   "
77696|NCT02040389|"~     The aim of this study is checking impact of visual guidelines (picture book) and tutoring in~     pediatric urologic surgery~   "
77697|NCT02040376|"~     A placebo controlled double blind crossover trial of metformin in 30 children treated with~     radiation for medulloblastoma - the most common malignant brain tumour. The investigators~     will use tests of thinking and learning and brain imaging techniques to examine whether~     metformin can enhance cognition or promote brain repair following radiation-induced brain~     injury.~   "
77698|NCT02040363|"~     COPD patients experiment a peripheral muscle dysfunction which impact their exercise~     tolerance and health-related quality of life. The capillary to fiber interface is reduced~     and impact the exercise capacity of the patients. While exercise training induce a~     physiological angiogenesis, we have recently observed that there was a blunted muscle~     angiogenesis after training in COPD patients. This could be the consequence a an inadequate~     training duration or intensity. Aim of the study: Compare the muscle micro-vascular response~     to training (capillary-to-fiber ratio) at 5 and 10 weeks, in sedentary healthy subject~     trained at the intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD~     patients trained at a similar intensity (60-65% of VO2max)- COPD patients trained at a~     similar absolute intensity (90% of VO2max).~   "
77699|NCT02040350|"~     To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide~     poisoning (Organophosphorous poisonings)~   "
77700|NCT02040337|"~     The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire~     differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy~     controls.~   "
77701|NCT02040324|"~     We measure in this study lung function of 100 patients immediately after major lower~     abdominal surgery. We compare lung function, when either endotracheal intubation, or~     laryngeal masks are used for airway protection during surgery. The hypothesis is that the~     use of laryngeal masks is associated with less impairment of lung function in the immediate~     postoperative phase.~   "
77702|NCT02040311|"~     The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or~     192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who~     participated in an eight week intensive non-pharmacologic weight loss program.~      The primary efficacy endpoint will be the percent change in body weight from enrollment~     visit to week 60.~   "
77703|NCT02040298|"~     The main purpose of this study is to assess clemastine as a remyelinating agent in patients~     with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of~     clemastine, originally approved as first-generation antihistamine, in patients with multiple~     sclerosis. Study procedures will include assessments for evidence of remyelination in the~     anterior visual pathway and in the brain using electrophysiologic techniques and magnetic~     resonance imaging. The study will also assess the robustness and stability of this clinical~     effect in patients taking clemastine for up to 3 months. Patients in this study can remain~     on their standard disease modifying treatment during the course of the study. However,~     patients cannot participate in any other investigational new drug research study~     concurrently.~   "
77704|NCT02040285|"~     The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography~     Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient~     tolerability and acceptance.~   "
77705|NCT02040272|"~     Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300~     people in the UK are diagnosed with mesothelioma each year and the average survival is~     approximately 17 months. Exposure to asbestos is the most common cause although the cancer~     does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs~     (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing~     surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this~     surgery, in addition to chemotherapy, can increase survival and improve the quality of life~     for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients~     with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and~     lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits~     for to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these~     visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are~     randomised to surgery) for mesothelioma research central storage and blood samples will be~     taken at the clinic visits up to 12 months for mesothelioma research central storage. If we~     can show the feasibility of recruitment we will apply to continue the study to include more~     patients in order to determine if lung-sparing surgery improves survival and quality of life~     for mesothelioma patients.~   "
77706|NCT02040259|"~     The purpose of the Trevo® Retriever Registry is to collect real world performance data of~     the Trevo Retriever which is intended to restore blood flow in the neurovasculature by~     removing thrombus in patients experiencing ischemic stroke.~   "
77707|NCT02040246|"~     The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the~     China Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes~     were well controlled.Among all kinds of antidiabetic medications, metformin is recommended~     as the first-line antihyperglycemic management for type 2 diabetes. Insulin~     secretagogue,repaglinide is still one of the most widely used antidiabetic medications in~     China. However, there were few studies comparing the effects of these two medications on~     glycaemic control in Chinese patients with type 2 diabetes.~   "
77708|NCT02040233|"~     This is a study to investigate the safety, tolerability and early effects on cardiac~     function of the partial A1 agonist BAY1067197 in patients with chronic heart failure.~     BAY1067197 will be applied once daily over 7 days in addition to standard therapy including~     a beta-blocker. The aim of the study is to assess if a 7 day treatment with BAY1067197 is~     well tolerated when given on top of standard therapy for heart failure. Furthermore, the~     study aims to assess if cardiac function improves in the early course of therapy.~   "
77709|NCT02040220|"~     This is a prospective, non-interventional, multi center post-authorization safety study that~     includes patients with a diagnosis of CRVO. The investigator will have made the choice of~     treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert~     prior to enrolling the patient in this study.~      The observation period for each patient starts when therapy with EYLEA is initiated. The~     enrollment period is 2 years. Patients will be followed for a time period of 2 years or~     until it is no longer possible (e.g. lost to follow-up) within the 2 years.~      For each patient, data are collected as defined in the case report form at the initial~     visit, follow-up visits and final visit, either by routine clinical visits (as per~     investigators routine practice).~      There will interim analysis of study data: 6 months after last patient first visit and~     J-PSUR(Japanese-Periodic Safety Update Report )~   "
77710|NCT02040207|"~     The purpose of this research study is to test the safety and local tolerance of repeated~     treatment with AM-101.~   "
77711|NCT02040194|"~     The purpose of this research study is to test the safety and effectiveness of the study~     drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of~     an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with~     tinnitus can take part in the study, if their tinnitus started within the last 3 months or~     within the last >3 to 6 months.~   "
77712|NCT02040181|"~     It's important to dose according to renal function in who has impaired kidney function.~     There are two common methods estimating renal function: one is creatinine clearance~     estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated~     by Modification of Diet in Renal Disease (MDRD) equation.~      The previous study (not published) showed that CG underestimated 24 hour measured urine~     creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to~     establish a estimated creatinine clearance equation fitting in Taiwanese.~      Besides, there are lots of studies discussing difference between CG and MDRD. We have found~     that MDRD overestimated CG in patients who were older or thin. Therefore, we want to~     analysis which characteristics of patients the difference are largest or smallest.~   "
77740|NCT02039817|"~     This is an open-label, parallel-group study to compare the pharmacokinetics and~     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with~     severe renal impairment and matched healthy volunteers with normal renal function.~   "
77768|NCT02039453|"~     During sedative colonoscopy, use of propofol have been increased world wide. The onset time~     of propofol is shorter than midazolam. However the most popular additive pain killer,~     pethidine show different pharmacodynamic feature. The pethidine has longer onset time than~     propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of~     fentanyl has been increased world widely. However, exact comparison of pethidine and~     fentanyl was not studied. Therefore, we designed this study to compare both drug to check~     satisfaction of this drug.~   "
77713|NCT02040168|"~     Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU).~     Its use requires almost always the establishment of a sedation. Sedation is a generic term~     for all procedures, pharmacological or not, ensuring physical and psychological comfort and~     the safety of patient admitted in intensive care units.~      An inadequate sedation, insufficient or excessive, has common side effects, as increase of~     the duration of mechanical ventilation and of hospital-acquired infections (in particular,~     ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or~     accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD).~     All these complications increase mechanical ventilation time and ICU length of stay. Several~     studies in adult's population have shown that the implementation of a sedation algorithm~     allowed to decrease the incidence of these complications.~      We hypothetized that the duration of mechanical ventilation would be reduced by a~     nurse-implemented sedative management protocol.~   "
77714|NCT02040155|"~     This is an observational study. The purpose is to determine the feasibility of using a novel~     nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of~     brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part~     of their standard therapeutic regimen will represent the study population.~   "
77715|NCT02040142|"~     This is a clinical study investigating the new treatment of surgery combined with~     intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the~     peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved~     by the U.S. Food and Drug Administration (FDA)for many different cancers including~     gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA~     approved and is an investigation therapy. Cytoreductive surgery plus intraperitoneal~     chemotherapy can be offered as standard of care outside of a clinical trial. However, since~     this is an unproven and potentially more effective but a more toxic approach, the~     investigators are performing this procedure under an IRB approved clinical trial in order to~     better evaluate the risks and benefits of this approach.~      A standardized, evidence-based approach is currently lacking for patients with peritoneal~     surface malignancy from gastrointestinal origin. A clinical trial with surgical quality~     assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical~     assessment of disease burden, determinants of complete cytoreduction, treatment-related~     toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery~     is performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is~     used to treat microscopic residual disease with the objective of removing disease completely~     in a single procedure.~   "
77716|NCT02040129|"~     This study was conducted to evaluate changes of reduction of corneal astigmatism with toric~     intraocular lens(IOL) in congenital cataract.~   "
77717|NCT02040116|"~     The purpose of this study is to evaluate the impact of rapid infusion rituximab on the~     incidence of infusion-related reactions in patients with Autoimmune Diseases.~   "
77718|NCT02040103|"~     Patients admitted to the intensive care unit are at high risk of developing clots in the~     veins of the lower extremities. The objective of this study is to examine whether the use of~     a device that provides intermittent compression to the legs in addition to the use of~     low-dose blood thinners, provides an additional protection when compared to the use of blood~     thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose~     blood thinners to prevent clots are candidates for this study. Patients who are enrolled~     will continue to receive blood thinners but some will additionally receive the leg~     compression. The additional use of leg compression may provide protection from clots. The~     main side effect is possible skin abrasions but this is usually mild. The study is sponsored~     by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for~     Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia,~     Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is~     to continue for 4 years.~   "
77719|NCT02040090|"~     The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in~     comparison with HRIG comparator product. 2. To assess whether KamRAB interferes with the~     development of self active antibodies when given simultaneously with active rabies vaccine,~     as compared to the HRIG comparator product, also given in conjunction with the active rabies~     vaccine.~   "
77720|NCT02040077|"~     Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in~     the general population. Fatal OD from opioid analgesics specifically has increased over 400%~     between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD.~     Unintentional opioid OD is a public health crisis in several societal populations including~     drug users, patients being treated for chronic pain, elderly individuals, adolescents, and~     children. Educational interventions have been developed to increase knowledge regarding~     opioid OD risk factors, symptoms, and appropriate responses, however no randomized~     controlled evaluations of these interventions have been conducted. Within-subject~     evaluations report immediate and sustained increases in participant knowledge and behavior~     change, yet these programs suffer from limitations that may limit their widespread~     dissemination. Thus, there is an urgent, critical need to develop an opioid OD educational~     intervention that can be accessed by a broad audience, and produces immediate and sustained~     gains in knowledge in an easily administered and cost-effective way. This study will develop~     a web-based, computerized, interactive, opioid OD education training program that will~     incorporate multi-media learning components and fluency training to produce knowledge gains.~     This program will be evaluated using a randomized, controlled comparison of the active~     intervention against two control interventions. Participants will be recruited from a brief~     inpatient detoxification (n=75), will receive the intervention immediately upon completing~     the detoxification (post-treatment), and will complete 2 follow-up visits to evaluate~     sustained knowledge. The primary outcome will be percent change from baseline on a knowledge~     test that is administered immediately before and after the intervention, and at a 1 and~     3-month follow-up visit. Secondary outcomes will include self-reported behavior change and~     participant acceptance of the intervention. The study hypothesis is that participants who~     receive the primary intervention will evidence the largest increase in knowledge gain and~     retention over time, compared to the control groups. The rationale and public health benefit~     of this research cannot be understated- this project will make available a brief,~     empirically-supported intervention that can be administered quickly and easily within~     hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers,~     primary care offices, schools), and to diverse patient populations (e.g., drug users,~     chronic pain patients, elderly, student, children, parents). These outcomes are expected to~     have a positive impact because they will provide cheap, easily-administered intervention~     strategy that will help reduce the current national epidemic of opioid OD, and will expand~     the use of computerized interventions to address public health issues more broadly.~   "
77766|NCT02039479|"~     The primary hypothesis of this confirmatory study is that lithium therapy will acutely~     decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive~     episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim~     is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo~     plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour~     over 5 weeks in inpatients with MDE.~   "
77721|NCT02040064|"~     This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib~     and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an~     activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such~     as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety~     and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and~     to establish a recommended phase 2 dose. Secondary objectives include evaluation of,~     pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab~     combination. The exploratory objectives are to evaluate biomarkers that may correlate with~     activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.~      The biological rationale for such a study is that even though the disease is progressing it~     is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR~     TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can~     potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation~     of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today~     no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover,~     patients may have received chemotherapy and the likelihood of chemosensitivity is very low.~     So, the association of Gefitinib with immune checkpoint blockade is very attractive and may~     result in clinical benefit in NSCLC with EGFRmut.~   "
77722|NCT02040051|"~     The purpose of this study is to assess the effect of sound insulation and music therapy on~     the comfort of mechanically ventilated patients admitted to intensive care unit measured by~     the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)~   "
77723|NCT02040038|"~     The purpose of this study is to determine whether participation in virtual environment which~     incorporates real-time diabetes self management and support (DSMT/S) is associated with~     positive changes in behavior and metabolic outcomes as compared to traditional web-based~     DSMT/S.~   "
77724|NCT02040025|"~     The purpose of this proposed Department of Defense study is to evaluate the effect of~     Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood~     pressure of type 2 diabetic patients receiving EECP therapy.~   "
77725|NCT02040012|"~     Objectives:~      Primary Objectives~        -  To investigate the safety and tolerability of single ascending doses of AZP- 531 in~          healthy volunteers.~        -  To investigate the safety and tolerability of single and multiple ascending doses of~          AZP-531 in overweight/obese volunteers.~        -  To investigate the safety and tolerability of single and multiple ascending doses of~          AZP-531 in patients with type 2 diabetes mellitus.~      Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after~     single and multiple doses.~      Exploratory Objectives~      • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers~     of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and~     unacylated ghrelin (UAG)~   "
77726|NCT02039999|"~     Despite its commonplace use in respiratory medicine the mechanism whereby inhalation~     challenge with a variety of mild acid aerosols produces a dose related and predictable cough~     is unknown. In this proposal the investigators wish to use established cough challenge~     methodology to explore the mechanism of action of agents provoking cough both in health and~     disease.~      The hypotheses to be tested include:~        -  Intracellular changes in pH, rather than extracellular changes, are key in the~          activation of TRP receptors, the main sensor for provoking cough.~        -  ATP acting through P2X channels is the mechanism of increased nerve excitability~          underlying cough hypersensitivity.~   "
77727|NCT02039986|"~     This study is aimed at better understanding the impact of ivacaftor upon insulin and~     incretin secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine~     (G551D) mutation. Investigators hypothesize that treatment with ivacaftor improves insulin~     secretion in individuals with CF.~   "
77728|NCT02039973|"~     Although there is a significant burden of depression among HIV-positive women in Tanzania,~     there is a critical gap between the needs of this population and the integration of mental~     health and PMTCT-plus services. The long-term intent of the research is to bridge this gap~     with the overall goal to examine the potential for successful integration of enhanced mental~     health care and brief group interventions among HIV-positive women receiving PMTCT-plus~     services and to evaluate a combination of evidence-based approaches for treatment of~     depression in this vulnerable population in Tanzania.~   "
77729|NCT02039960|"~     Bupropion hydrochloride was first approved on 30 December 1985 in United States for~     depression and is currently approved in 80 countries. Bupropion has also subsequently been~     approved for smoking cessation and for seasonal affective disorder.~      Cumulative exposure to bupropion is estimated at approximately 97.3 million patient~     exposures up to 31 December 2012.~      Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting~     serotonin, norepinephrine and dopamine. Its mechanism of action and its structural~     similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in~     many respects, leading to concerns about potential abuse of the product.~      Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until~     2003 and at that point, had no longer been regarded as a potential risk that required~     additional/further evaluation outside standard pharmacovigilance monitoring. The current~     European Risk Management Plan also states that standard pharmacovigilance monitoring applies~     to abuse potential. Monitoring has shown a recent increase in the number of spontaneous~     reports from the Adverse Event reporting System (AERS) of drug abuse.~      The bupropion team agreed that although the numbers of abuse reports was small relative to~     the total number of reports for bupropion in OCEANS, there was sufficient information in~     AERS to warrant investigation of the potential effect on public health.~      To investigate the degree of misuse and abuse of bupropion (including non-oral routes of~     administration) in the United States, the Drug Abuse Warning Network will be used to examine~     the study period 2004-2011.~   "
77730|NCT02039947|"~     This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and~     Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma~     that has metastasized to the brain. This study will evaluate the safety and efficacy of 4~     cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain,~     symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without~     prior local (brain) therapy, and range of ECOG scores from 0-2.~   "
77733|NCT02039908|"~     Although stimulant medication is a well-established treatment for ADHD, it is often~     necessary for doctors to increase the dose over time to maintain the benefits of the~     medication. While medication can be very effective for improving symptoms of ADHD during the~     first year of use, it has not been found to significantly improve the long term course of~     children with ADHD. For example, in large research studies, groups of children who take~     medication for ten years do not have consistently better academic grades than groups of~     children who never used medication (individual results will vary from child to child).~      In order to help children with ADHD achieve the best possible outcomes, it is important for~     doctors to study why this happens. One possible reason is development of tolerance to the~     medication. Tolerance means that a drug's effects decrease when it is taken consistently~     over time, so that an increased dose is needed to continue showing effects. Some doctors~     believe that children who take stimulant medication for ADHD develop tolerance to it which~     would explain why benefits may not persist over time, but no research studies have been done~     to measure whether this occurs. This study aims to see if children show a tolerance effect~     to stimulant medication and whether that tolerance can be prevented by taking short breaks~     from the medication called medication holidays.~   "
77734|NCT02039895|"~     Radiation therapy, Total skin electron beam therapy (TSEBT), achieves a high response rate~     and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial~     region. One the most widely used TSEBT techniques consists of six dual fields initially~     developed at Stanford University. However, deviations occur from the prescription dose up to~     40% and the surface dose inhomogeneity as much as 90% in body areas such as the perineum and~     eyelid.~      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment~     length of up to 160 cm, continuously in a helical pattern without the need for field~     junction. Using HT, an image-guided intensity-modulated radiotherapy, to replace~     conventional TSEBT technique to increase dose delivery and decrease toxicities possibly.~     Recently, we published the possibility of helical irradiation of the total skin (HITS) by~     physical proving and showed the clinical results of HITS successfully for a woman with T~     cell lymphoma failure by chemotherapy, topic UV irradiation and local radiotherapy (RT) to~     overcome the surface dose inhomogeneity by conventional RT.~      Here, investigators will enroll the stage I-IV cutaneous T-cell lymphoma (CTCL) of~     International Society Cutaneous Lymphomas (ISCL)/U.S. Cutaneous Lymphoma Consortium~     (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are~     candidates for TSEBT by recommendation of National Comprehensive Cancer Network Guidelines~     (Version 4.2011, Mycosis fungoid/Sezary syndrome) or who are refractory or not feasible to~     the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy,~     and Accutane® (Isotretinoin) or chemotherapy to receive HITS to replace TSEBT. Additionally,~     we will compare the advantages and disadvantages between the plan of HT and conventional RT~     for TSEBT.~   "
77735|NCT02039882|"~     Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by~     significant coronary artery disease on cardiac catheterization/revascularization or~     reversible defect seen on stress test. Each year approximately 8-10 million patients undergo~     an emergency department evaluation for possible acute coronary syndrome (ACS) in the United~     States Up to 8%of patients who have myocardial infarction (MI) are inadvertently discharged.~     Unnecessary admissions for presumed myocardial disease result in health care costs that are~     estimated to exceed 5 billion dollars annually Currently, the cardiac biomarkers troponin~     and Creatine phosphokinase (CPK-MB), in conjunction with ECG changes are used to evaluate a~     patient routinely for ACS. However, these tests have limitations for identifying most~     patients who have ACS in a rapid fashion. Purine molecules such as inosine and hypoxanthine~     and have been shown to also be biomarkers of acute MI. High pressure liquid chromatography~     (HPLC) is the traditional method of analysis of these purines. The HPLC method however~     requires hours to assess biomarkers, as do the more traditionally used troponin and CK-MB~     methods.~      Recently, the investigator has developed a rapid chemo luminescence method for detecting~     purine biomarkers. This modality can provide an expeditious (requires less than 4 minutes to~     complete analysis), bedside method of analysis for ACS through routinely acquired blood~     samples. In this study the investigator will compare the results of the chemo luminescence~     method with the gold standard HPLC method, and results of the traditional cardiac markers~     troponin and Creatine phosphokinase (CK-MB) in patients undergoing an evaluation for ACS.~     Details of noninvasive and invasive cardiac assessments performed as part of the routine~     evaluation by the clinician for myocardial assessment and intervention in conjunction with~     biomarker assessment will be obtained. The investigator hypothesize that the rapid chemo~     luminescence biomarker assessment will identify patients with ACS faster than traditional~     diagnostic methods.~      The goal of this study is to assess the role of rapid assessment of purine biomarkers in~     identifying patients who may have ACS.~   "
77736|NCT02039869|"~     The purpose of this study is to find out if people who have non-erosive reflux disease~     (NERD) have changes the investigators can see with a microscope (called confocal~     endomicroscopy) that is used during endoscopy (a camera scope evaluation of the inside of~     your stomach and swallowing tube). Traditionally the investigators have used trials of acid~     blocking medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the~     esophagus) to determine if the investigators think acid is causing troublesome symptoms. The~     medical community believes that these symptoms are due to increased spaces between the cells~     that make up the swallowing tube. The investigators can directly see those spaces with a new~     microscope that the investigators can pass through the camera scope.~      Participants will be assigned to take one of two medications omeprazole and sucralfate (both~     approved medications for stomach symptoms) to treat their symptoms and record how well the~     treatment works. The investigators then will look to see if the microscope can predict which~     medication will work best for patients in the future. The investigators also plan to measure~     the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube~     and stomach as this is standard for patients with your symptoms. The investigators will~     compare the results of those studies to the microscope findings.~   "
77737|NCT02039856|"~     VA has undertaken a major initiative to transform care through implementation of Patient~     Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT~     aims to improve access, continuity, coordination and comprehensiveness using team-based care~     that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the~     needs of special populations, such as women Veterans, is yet to be worked out. The main goal~     of this study is to develop and test an evidence-based quality improvement (EBQI) approach~     to adapting and implementing PACT for women Veterans, incorporating comprehensive women's~     health care in gender-sensitive care environments, thereby accelerating achievement of PACT~     tenets for women Veterans and reducing persistent gender disparities in VA quality of care.~   "
77738|NCT02039843|"~     Service Dogs are trained to assist people with disabilities to accomplish tasks which permit~     the individual to be more functional in their home and social environment. Often the dogs~     are trained to help in the completion of activities of daily living and instrumental~     activities of daily living. Service Dogs are efficacious for individuals with disabilities,~     such as vision limitations, spinal cord injury and hearing problems. In addition, some~     mental health outcomes have improved with the introduction of a Service Dog. A research~     study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of~     service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the~     Cooperative Studies Program, the proponents have designed a research study to effectively~     meet the demands of the Bill and to provide timely research into an evolving field.~   "
77741|NCT02039804|"~     Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve~     pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient~     clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter~     major, overlying the lateral aspect of the hip. When pain is persistent after conventional~     therapies, anesthetic and corticosteroid (CS) injections can provide short term to~     intermediate relief of pain, but relapse is common. Only one retrospective study showed the~     efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the~     pain release is significant with large effect sizes for both treatment. However, the~     efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and~     12 months is significant compared to CS (p<0.05).~      In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the~     treatment of trochanteric bursitis.~   "
77742|NCT02039791|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical~     phaseⅡtrial is designed to assess the resection rate and pathological complete response of~     nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.~   "
77743|NCT02039778|"~     There are preliminary studies that suggest that radiation therapy to areas of the brain~     containing cancer stem cells (in addition to the area where the tumor was surgically~     treated) may help patients with high-grade brain tumors live longer. The purpose of this~     study is to determine whether the addition of stem-cell radiation therapy to the standard~     chemoradiation will further improve the outcome. The investigators will collect information~     about the patient's clinical status, disease control, neurocognitive effects, and quality of~     life during follow-up in our department.~      The purpose of the study is to improve the overall survival patients with newly diagnosed~     malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The~     investigators will also measure how patients treated with this novel method of radiation~     therapy do over time in terms of disease control, potential neurocognitive side effects,~     overall function, and quality of life.~   "
77744|NCT02039765|"~     To characterize the plasma pharmacokinetics and safety profile of brimonidine following a~     single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution~     0.025% for 7 days in healthy, adult subjects.~   "
77745|NCT02039752|"~     The purpose of this study is to evaluate long-term prognoses of patients with multivessel~     coronary disease treated medically or surgically or percutaneously in real world practice.~   "
77746|NCT02039739|"~     The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting~     Stent in Routine Clinical Practice~   "
77747|NCT02039726|"~     The primary objective of the study is to determine whether quizartinib monotherapy prolongs~     overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine~     kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have~     relapsed within 6 months, after first-line AML therapy.~   "
77748|NCT02039713|"~     The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine~     Clinical Practice~   "
77749|NCT02039700|"~     This study will assess the absolute bioavailability of a single oral dose of lesinurad and~     evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy~     adult male subjects.~   "
77750|NCT02039687|"~     The purpose of this study is to determine whether ARA 290, a new class of compound, is~     effective in the treatment of the neuropathic symptoms of sarcoidosis. Brief interaction of~     ARA 290 with the innate repair receptor results in anti-apoptotic and anti-inflammatory~     activities in myriad of cells, tissues and organs throughout the body to activate repair~     mechanisms and accelerate healing, including the nerve damage that can be associated with~     sarcoidosis. In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy~     will administered ARA 290 or placebo by subcutaneous injection daily for 28 days. In~     addition to monitoring the safety of the treatment, the symptoms of the subjects will be~     assessed with several questionnaires, function tests, and measurement of nerve fibers in~     their cornea and skin (via a non-invasive test and a biopsy, respectively). The total~     participation time for each patient will be 16 weeks.~   "
77751|NCT02039674|"~     The purpose of this study is to determine safety, tolerability, and efficacy of~     pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants~     with unresectable or metastatic non-small cell lung cancer (NSCLC~   "
77752|NCT02039661|"~     The effect of lidocaine spray on pain relief during endometrial sampling.~   "
77753|NCT02039648|"~     Periodontitis is a biofilm depended oral infection. It leads to inflammatory destruction of~     periodontal tissues and if left untreated to tooth loss. Porphyromonas gingivalis (P.g.) is~     one of the major pathogens associated with the onset and progression of periodontitis.~     Previous in vitro studies have shown that a proanthocyanidin-enriched extract from Rumex~     acetosa L. inhibits the adhesion of P.g. and acts in a cytoprotective manner. Since the the~     bacterial adhesion to oral mucosa cells is a pivotal step for the P.g. mediated tissue~     destruction, its inhibition may be helpful in preventing the colonization with P.g. or its~     eradication in P.g. infected patients. Therefore, the aim of this controlled, randomized and~     double blinded study was to analyze the effects of a Proanthocyanidin-enriched extract from~     Rumex acetosa L. on the intraoral colonization with Porphyromonas gingivalis in individuals~     harboring P.g. intramurally.~   "
77754|NCT02039635|"~     Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether~     Korean Red Ginseng is effective compared with a placebo in chemotherapy.~      The purpose of this study is to determine whether Korean Red Ginseng is effective in the~     treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)~   "
77755|NCT02039622|"~     The study is multicenter, post-authorization, observational and ambispective~   "
77767|NCT02039466|"~     Postoperative pulmonary complications following abdominal surgery are frequent and~     associated with increased morbidity and mortality and hospital length of stay. Pressure~     controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for~     laparoscopic colectomy, decreasing postoperative pulmonary complications.~   "
77756|NCT02039609|"~     In the post-genomic era, a major challenge for health research is to understand the complex~     interactions among genetic, environmental and lifestyle factors including dietary intake.~     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake~     assessment methods for large studies. The newly emerging field of metabolomics offers unique~     possibilities to characterize individual food intake, dietary patterns and effects of~     dietary intervention in large studies. The investigators propose to develop a platform to~     detect broad metabolomic responses to food intake in controlled trials as well as to use~     targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our~     laboratory has a long history of developing methodology for assessing nutritional status and~     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy~     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern~     metabolomics equipment and competence in bioinformatics, and use this in the context of~     nutrition research. To their knowledge, the investigators are among the first groups in the~     country to develop skills in metabolomics to assess dietary intake and effects of nutrition~     on metabolism, and probably the first to use two complementary platforms with both~     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results~     should be useful to nutritional scientists nationally as well as internationally.~   "
77757|NCT02039596|"~     In the post-genomic era, a major challenge for health research is to understand the complex~     interactions among genetic, environmental and lifestyle factors including dietary intake.~     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake~     assessment methods for large studies. The newly emerging field of metabolomics offers unique~     possibilities to characterize individual food intake, dietary patterns and effects of~     dietary intervention in large studies. The investigators propose to develop a platform to~     detect broad metabolomic responses to food intake in controlled trials as well as to use~     targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our~     laboratory has a long history of developing methodology for assessing nutritional status and~     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy~     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern~     metabolomics equipment and competence in bioinformatics, and use this in the context of~     nutrition research. To their knowledge, the investigators are among the first groups in the~     country to develop skills in metabolomics to assess dietary intake and effects of nutrition~     on metabolism, and probably the first to use two complementary platforms with both~     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results~     should be useful to nutritional scientists nationally as well as internationally.~   "
77758|NCT02039583|"~     The purpose of this study is to investigate whether there has been a change in low birth~     weight and perinatal and infant mortality following the July 2007 introduction of a ban on~     smoking in public places and workplaces in England.~   "
77759|NCT02039570|"~     This case series aims to find out in a group of female patients suffering from haemorrhoids,~     how many of them have pelvic vein reflux that feeds into their haemorrhoids.~      This will be done by examining their ovarian and internal iliac veins for reflux, using a~     transvaginal scan.~   "
77760|NCT02039557|"~     This is an observational study that will monitor patient's clinical outcomes. A patient can~     enroll in the NiCord® Long Term Follow Up Protocol only after the informed consent has been~     signed, and he/she has completed the study specific follow-up.~   "
77761|NCT02039544|"~     A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi~     Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi~     Deficiency and Blood Stasis)~   "
77762|NCT02039531|"~     HYPOTHESIS:~      The application of plasma rich in growth factors (PRGF) will improve the quality of life and~     functional capacity of patients diagnosed with knee osteoarthritis, providing better~     functional results than conventional treatment with viscosupplementation.~      OPERATING ASSUMPTIONS~      Following the initial administration of three doses of PRGF interspersed every 15 days,~     applied via intraarticular, patients will present an improvement in functional test (WOMAC~     and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with~     patients treated with hyaluronic acid.~   "
77763|NCT02039518|"~     The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine~     Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined~     With Platinum Based First-line Chemotherapy~   "
77764|NCT02039505|"~     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,~     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002~     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or~     severely active ulcerative colitis.~   "
77765|NCT02039492|"~     Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive~     patients have uncontrolled blood pressure despite a regimen of ≥ 3 drugs, which is known as~     resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in~     controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume~     homeostasis and blood pressure. A novel minimally invasive technique based on the use of~     selective radiofrequency renal sympathetic denervation has shown promising preliminary~     results for the treatment of these patients. On the other hand, some patients with RH could~     improve their blood pressure control by adding spironolactone, an antagonist of aldosterone~     receptors.~      Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in~     patients with RH, as compared with the addition of spironolactone to the therapeutic regimen~     at baseline.~      Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with~     RH, with office systolic blood pressure ≥ 150 mmHg and also with 24h systolic blood pressure~     ≥ 140 mmHg, despite treatment with ≥ 3 drugs in adequate doses, one of them a diuretic, and~     whitout treatment with either spironolactone or eplerenone. Patients will be randomized~     (1:1) to renal sympathetic denervation treatment or spironolactone (50mg), performing~     determination of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months,~     as well as laboratory tests, echocardiography, measurement of carotid intima-media thickness~     and central blood pressure measurement at pre-randomization and after 6 months.~   "
77769|NCT02039440|"~     The purpose of this study is to determine whether there are persisting antibodies against~     Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or~     confirm mathematical models accordingly.~   "
77770|NCT02039427|"~     Sore throat is one of most frequent complaints related to general anesthesia with tracheal~     intubation. Although sore throat is regarded as a minor and short-lasting discomfort after~     surgery, its incidence and intensity in high risk patients such as female gender, head and~     neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative~     recovery and give patient dissatisfaction.~      Even though the pathophysiology of post-intubation airway symptoms is not completely~     clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has~     been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly~     used strategy to prevent postoperative airway discomfort after intubation. The preoperative~     administration of dexamethasone has been reported to reduce the incidence and severity of~     postoperative sore throat, but it is accompanied with the adverse effects such as~     hyperglycemia, delayed wound healing and increased infection in surgical patients.~     Ketorolac, non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used~     for postoperative pain control and has anti-inflammatory effect.~      Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in~     comparison to dexamethasone after thyroidectomy in female adult patients~   "
77771|NCT02039414|"~     Regular maternal physical activity leads to the delivery of lighter, leaner infants. Higher~     birth weights and childhood obesity are both strong predictors for adult obesity, suggesting~     that the impact of maternal physical activity on the future health of a child is~     substantial. However, the mechanisms underlying the relationships between maternal physical~     activity and improved infant outcomes are unclear. Thus, the purpose of this project is to~     measure two potential contributing factors: maternal fat metabolism and maternal oxidative~     stress profiles. The investigators believe that maternal physical activity leads to~     beneficial alterations in maternal fat metabolism and oxidative stress profiles. Further,~     the investigators believe that both maternal fat metabolism and oxidative stress levels are~     related to infant outcomes such as obesity and insulin resistance. Therefore, exercise will~     improve maternal metabolic factors that can lead to improvements in infant outcomes. The~     investigators will compare these factors between obese inactive pregnant women and obese~     active pregnant women. This study design will allow us not only to determine the effect of~     physical activity on maternal and neonatal pregnancy outcomes, but also to establish whether~     obesity or physical inactivity should be a primary area of focus when prescribing pregnancy~     interventions in clinical practice.~   "
77772|NCT02039401|"~     The purpose of this study is to determine the safety and tolerability of intramuscular~     injections of VM202 at different injection sites in people with amyotrophic lateral~     sclerosis.~   "
77773|NCT02039388|"~     The current study aims at answering the scientific question, whether exfoliated cells from~     STICs get transported into the uterine cavity via the fallopian tube, and whether it is~     possible to detect those cells in the lavage fluid from the uterine cavity and proximal~     fallopian tubes.~      To address this question, the investigators will study 20 lavage samples and their 20~     corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral~     salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of~     the pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion~     for sterilization. Women who opt to have the fallopian tubes removed but the ovaries~     preserved are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.~   "
77774|NCT02039375|"~     Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for~     treatment of acute ischemic stroke. In the United States, IV tPA is typically administered~     in the Emergency Department (ED) for patients presenting with acute ischemic stroke within~     4.5 hours of symptom onset. It is current practice that post-tPA patients are monitored in~     an intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in~     part due to frequent vital sign and neurological monitoring that is currently the standard~     of care. However, rigorous evidence to support this practice is largely lacking. In a~     retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and~     Johns Hopkins Bayview Medical Center (JHBMC), we have shown that most patients who have ICU~     needs in the first 24 hours after tPA administration develop such needs by the end of the~     tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not require~     further ICU resources if their presenting NIH Stroke Scale (NIHSS) is below 10. This study~     is a prospective clinical trial that aims at establishing the first proof-of-concept and~     feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU~     care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a~     novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a~     non-ICU environment may improve cost-effective utilization of ICU resources and reduce the~     length of hospitalization for stroke patients.~   "
77775|NCT02039362|"~     The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around~     30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using~     tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from~     Western countries are needed.~   "
77786|NCT02039219|"~     The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in~     patients with moderately severe alcoholic hepatitis. The researchers suspect that~     individuals with alcoholic hepatitis have certain abnormalities in how their body handles~     bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic~     acid has been shown to affect bile acid abnormalities and thus it is possible that~     obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.~   "
77787|NCT02039206|"~     To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar~     deficits in patients with SCA3 and to establish its safety in this population.~      Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil~     may induce significantly therapeutic effects in patients with SCA3 and will pave the way for~     establishing a novel and effective treatment for this disorder.~   "
77885|NCT02037932|"~     The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm~     occlusion and retreatment rates as well as adverse event rates in patients undergoing~     balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and~     second-generation MicroVention hydrogel coils for treatment of previously treated or~     untreated ruptured and unruptured intracranial aneurysms.~   "
77776|NCT02039349|"~     Background:~      - Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is~     mainly produced by the stomach and stimulates appetite. Some studies suggest it may~     stimulate alcohol craving and use. Drugs have been developed that block ghrelin. Researchers~     want to know if people can tolerate a particular drug that blocks ghrelin. It will be given~     at two dose levels, combined with alcohol.~      Objective:~      - To determine if a drug that may decrease alcohol consumption when given along with alcohol~     is safe and tolerable.~      Eligibility:~        -  Healthy adults 21 65 years old who have 14 (women) to 21 (men) drinks a week.~        -  No one of childbearing potential can participate.~      Design:~        -  Participants will have 3 inpatient clinic visits; each will last 4 days.~        -  They will have physical exam and blood and urine tests.~        -  They will have breath tests for alcohol and smoking.~        -  They will answer health and mood questions.~        -  Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.~        -  They will eat only the food provided by the clinic. They will keep a food diary 1 day~          before each stay.~        -  They will be randomly assigned to take the study drug or placebo 5 times each stay.~        -  On Day 3, they will drink alcohol after taking the drug. They will give many blood~          samples that day through a tube inserted in their skin.~        -  Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.~        -  One week after the last stay, participants will have a follow-up visit to answer~          questions.~   "
77777|NCT02039336|"~     This is a phase I/II multi-center open-label proof of concept study, consisting of two~     parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of~     the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant~     (KRASm) colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or pancreatic cancer.~     Part B is designed to perform a randomized comparison of the combination of dacomitinib and~     PD-0325901 versus standard of care therapy in patients with advanced KRASm CRC, NSCLC, or~     pancreatic cancer. It is hypothesized that with this combination strategy the progression~     free survival of patients with KRASm CRC, NSCLC or pancreatic cancer will be doubled.~   "
77778|NCT02039323|"~     The purpose of this study is to determine the feasibility of a novel method to assess~     antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical~     tissue biopsies.~   "
77779|NCT02039310|"~     The investigators proposes a prospective cohort study in patients with high risk bladder~     cancer who have opted for radical cystectomy. The investigators aim to correlate~     pre-operative measures of body composition, cognitive and functional status with impaired~     survival at 6 months after cystectomy. Impairment in this context will be a compilation of~     several specific objective measures including: 1) death from any cause, 2) major~     complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance~     status, and 5) global well-being. The study team believes that Impairment Free Survival is~     an important endpoint as it accounts for many aspects of a patient's functional status that~     might alter a patient's choice to proceed with radical surgery.~   "
77780|NCT02039297|"~     In this multicenter project, we will introduce AWARE (electronic interface) Using a~     cloud-based technology . The goal of this project is to improve compliance with best~     practice through the use of a new acute care interface with built-in tools for error~     prevention, practice surveillance and reporting (ProCCESs AWARE - Patient Centered~     Cloud-based Electronic System: Ambient Warning and Response Evaluation).The goal of this~     project is to develop and test a novel acute care interface with built-in tools for error~     prevention, practice surveillance, decision support and reporting (ProCCESs AWARE - Patient~     Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation). In~     preliminary studies, these novel informatics supports built on an advanced understanding of~     cognitive and organizational ergonomics, have significantly decreased the cognitive load of~     bedside providers and reduced medical errors. Using a cloud-based technology, AWARE will be~     uniformly available on either mobile or fixed computing devices and applied in a~     standardized manner in medical and surgical ICUs of five geographically diverse acute care~     hospitals predominantly serving Medicare and Medicaid patients. The impact of ProCCESs AWARE~     on processes of care and outcomes in study ICUs; expected to enroll more than 10,000~     critically ill patients during the study period.~   "
77781|NCT02039284|"~     Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and~     loss of dexterity are the major problems in patients with CP. A novel virtual cycling~     training (VCT) program for lower limb was to enhance promising muscle strength through~     promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of~     whole hand is a novel technique and is commonly used to treatment of spasticity for patients~     with stroke. Constraint-induced therapy (CIT) is a method for treating developmental~     disregard and learned non-use of affected limb and improving motor efficiency, functional~     performance, and activities of daily living for patients with CP.~   "
77782|NCT02039271|"~     The aim of the present study is to determine if the use of music as an intervention can be~     utilized, in conjunction with normal pharmacological treatment, in decreasing pain and~     increasing patient satisfaction, in male and female total knee replacement patients, from~     the age of 50 and 70, during the first 48 postoperative hours after surgery. It is the hope~     that this study can add to current research addressing the pain relief needs of orthopedic~     patients following total knee replacement surgery using music listening as an adjuvant~     therapy.~   "
77783|NCT02039258|"~     The purpose of this study is to assess the effect of coadministration of a high-fat meal on~     the oral bioavailability of a fixed dose combination of Canagliflozin/extended release~     Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in~     healthy participants.~   "
77784|NCT02039245|"~     The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2~     Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150~     mg/1,000 mg each) following once-daily oral dosing in healthy participants.~   "
77785|NCT02039232|"~     The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw~     System in the lumbar spine.~   "
77886|NCT02037919|"~     Women who receive Nexplanon immediately post abortion will be significantly more likely to~     be using the device 6 months after the procedure than those assigned to receive the device~     2-4 weeks after the procedure.~   "
77788|NCT02039193|"~     Background: Psychotherapy is an effective treatment for generalized anxiety disorder in~     comparison to no-treatment controls. Instead of creating more and more new overall~     treatment-packets within a medical meta-model, a complementary approach to investigate~     clinical research designs may lie into the understanding of already effective~     psychotherapies. Treatment manuals and protocols allow a relatively high degree of freedom~     of therapists' behaviors on how to implement the overall treatment manuals. There is a lack~     of systematical knowledge of how therapists have to customize these overall protocols. The~     present design experimentally examines 3 types of conducting a 15 session time-limited~     cognitive-behavioral therapy (CBT) protocol and its relation to the therapists' protocol~     adherence and treatment efficacy.~      Methods/design: This trial investigates 3 different types of how to customize a~     well-introduced CBT-protocol using dyadic peer tutoring methodology (primings). The~     individuals with GAD are randomly assigned to 3 priming conditions (resource priming vs.~     supportive resource priming vs. adherence priming). Participants' treatment allocation is~     performed randomly, therapist's assignment to the peer tutoring partner and the priming~     condition is based on mutual agreement. Treatment outcomes are assessed at following levels:~     Observer based in-session outcomes, post-session outcomes from session 1 to 15, treatment~     outcome at post assessment and at 6-months follow-up assessments.~   "
77789|NCT02039180|"~     This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single~     doses of AZD3293 (2 different tablet formulations, and an oral solution) will be~     administered with a washout period of at least 1 week between the doses to investigate the~     relative bioavailability of AZD3293 after administration via 2 tablet formulations compared~     with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet~     formulations compared to the oral solution of AZD3293.~      The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the~     study. AZD3293 is being developed for the treatment of Alzheimer's disease~   "
77790|NCT02039167|"~     The purpose of this study is to evaluate the superiority of left atrial appendage occlusion~     in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the~     frequency of occurrence of at least one bleeding classified as moderate or major within 24~     months.~   "
77791|NCT02039154|"~     The purpose of this study is to determine whether vigorous exercise training 4-5 days/week~     for 2 years in sedentary middle aged men and women (ages 45-64) will improve cardiac and~     vascular compliance to a degree equivalent to life-long exercisers and the sedentary young.~     Sedentary aging is associated with impaired diastolic function, which can lead to heart~     failure. However, if exercise training can be implemented early enough in life while~     cardiovascular plasticity still exists, then functional capacity can be maintained,~     preventing heart failure.~   "
77792|NCT02039141|"~     The purpose of this study is to examine the effects of 12 week lifestyle intervention on~     diabetes risk in obese Latino adolescents.~   "
77793|NCT02039128|"~     In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d~     krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.~      Primary objective is to determine if a 12 week supplementation with krill oil increases~     tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose~     adjustments to EPA and DHA levels.~   "
77794|NCT02039115|"~     Complete endoscopic resection of early neoplastic BE is a curative procedure. However, a~     significant proportion of patients develop symptomatic esophageal strictures following CBE,~     and this limits the technique, particularly for circumferential and longer segment disease.~     Oral steroid therapy may reduce stricture formation; thereby allowing CBE to be performed~     with minimal associated morbidity.~   "
77795|NCT02039102|"~     Studies examining the sex differences in the epidemiology and morbidity patterns of asthma~     show that the rates of disease severity, healthcare utilisation, and poor quality of life~     are considerably higher in women than in men, and this has been attributed to endogenous and~     exogenous sex hormonal factors. Studies examining the impact of use of hormonal~     contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are~     conflicting.~      In the present study, the investigators utilize data from the Scottish Health Survey, a~     national representative sample, to investigate the associations between current use of~     hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma~     and wheezing symptoms in Scottish women. The investigators hypothesize that while current~     use of any hormonal contraceptives and combined oral pills are associated with higher~     prevalence of asthma and asthma outcomes, current use of progesterone-only contraceptives is~     not associated with asthma. A secondary aim of the current study is to examine whether there~     is evidence of any biological interaction between use of hormonal contraceptives and BMI in~     relation to the risk of asthma and asthma outcomes.~   "
77796|NCT02039089|"~     This study will be a single-center, multiple-dose, randomized, double-blind,~     placebo-controlled, parallel-group study in healthy male and female subjects. The study will~     consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and~     Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be~     conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed~     by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in~     parallel with the 10-mg cohort of Part A, with the possibility of overlap.~   "
77797|NCT02039076|"~     This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of~     avatrombopag following a single administration of avatrombopag in the fed and fasted~     condition, or the fed condition, to healthy Japanese and white subjects. A standard~     high-fat, high calorie breakfast will be used to assess the fed condition.~   "
77798|NCT02039063|"~     This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study~     to evaluate mainly the safety and tolerability of 12-week repeated intravenous~     administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects~     per cohort will receive repeated intravenous administration of E6011.~   "
77904|NCT02037685|"~     Statins are cholesterol lowering medications that reduce the risk of cardiovascular events.~     However adherence to these medications has been found to be lower among minorities, a group~     particularly vulnerable for heart disease.~      The purpose of this study is to compare the efficacy of a phone based behavioral~     intervention to mailed educational materials regarding how to control cholesterol and other~     risk factors. We hypothesized that the behavioral intervention will improve adherence to~     statins by 15%.~   "
77799|NCT02039050|"~     In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or~     blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the~     airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic~     antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a~     new LAMA called aclidinium has been approved for use in COPD. There are potentially~     important differences between these two medications that might have an impact on the~     treatment of COPD patients.~      In this study we aim to compare the effects of tiotropium and aclidinium in people with~     COPD. The main comparison will be done using a very sensitive breathing test called impulse~     oscillometry~   "
77800|NCT02039037|"~     Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high~     rate of employee absenteeism and reduced functional performance. The use of acupuncture as~     an alternative therapy in the treatment of low back pain and electroacupuncture to enhance~     the treatment has been effective; however, there is little evidence of the effectiveness of~     one over the other.~   "
77801|NCT02039024|"~     The primary objective of this protocol is to investigate the monoaminergic~     (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in~     Parkinson's disease patients with non-motor symptoms (focus on impulse control disorders and~     dementia) by novel 18F-DTBZ and Florbetapir F-18 PET imaging.~      This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and~     monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.~      Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.~   "
77802|NCT02039011|"~     Asthma is a common condition which produces a significant workload for general practice,~     hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of~     the airways which irritates the muscles around the airways causing them to constrict. The~     mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not~     adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the~     muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite~     this, a substantial proportion of asthmatic patients still do not achieve adequate control~     of their symptoms. Recent studies have shown when an alternative inhaler called a~     long-acting muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of~     asthma exacerbations (flare-ups) and improved airway narrowing.~      The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma.~     There have been no previous studies assessing the combined effects LABA and LAMA inhalers on~     mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli~     encountered in real life which provoke an asthma attack.~      The investigators propose to directly compare indacaterol, a new once-daily LABA with~     indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in~     persistent asthmatics using the mannitol challenge. The investigators hope that this study~     will help us understand how the combination of a LABA and LAMA might help protect against~     flare-ups.~   "
77803|NCT02038998|"~     Stroke is one of the leading causes of death and disability worldwide. More than 85% of~     strokes are due to blood vessel occlusion resulting in partial destruction of the brain~     parenchyma. Current protocols try to re-establish blood circulation as soon as possible~     through chemical and/or mechanical interventions but new strategies are needed.~      Periodic acceleration (pGz) is a non-invasive method consisting in the application of a~     rocking movement to the patient that ultimately will induce the release of beneficial~     chemicals from the vascular endothelium (the cells lining the inside of the blood vessels).~     Application of pGz in an animal model of stroke resulted in a dramatic reduction of~     associated brain damage.~      This trial will investigate whether stroke patients exposed to pGz experiment significantly~     higher recovery than patients that remained static during their treatment.~   "
77804|NCT02038985|"~     The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green~     (ICG) dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate~     visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis~     resection procedure.~   "
77805|NCT02038972|"~     To determine if autologous human umbilical cord blood infusion in children with acquired~     hearing loss is safe, feasible, improves inner ear function, audition and language~     development.~   "
77806|NCT02038959|"~     Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care~     enhanced with educational materials to usual care, educational materials, and the delivery~     of specialty care via telemedicine into patient's homes. The study's specific aims are the~     following:~        1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the~          homes of individuals with Parkinson disease who have limited access to care;~        2. To show that such an approach can improve quality of life;~        3. To establish that the telemedicine can enhance the quality of care; and~        4. To demonstrate that this remote approach to care saves time, reduces travel, and~          decreases care partner burden.~   "
77807|NCT02038946|"~     The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by~     independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in~     subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating~     agent.~   "
77808|NCT02038933|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     DLBCL in patients that have failed or are ineligible for ASCT~   "
77809|NCT02038920|"~     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,~     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002~     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or~     severely active Crohn's disease.~   "
77810|NCT02038907|"~     The purpose of this study is to select the optimal formulation of the norovirus vaccine from~     different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant~     (3-O-desacyl-4'-monophosphoryl lipid A) for further development.~   "
77811|NCT02038894|"~     The purpose of this research study is to compare the safety and effectiveness of three~     commonly used techniques for delivering anesthesia during a procedure known as~     esophagogastroduodenoscopy.~   "
80610|NCT02002299|"~     The purpose of this study is to investigate the invasive front in growth mode (expanding or~     infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor~     surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.~   "
77812|NCT02038881|"~     The main purpose of this clinical trial is to generate additional safety data in a highly~     immunocompromised population. HIV-infected persons are considered excellent candidates to~     represent the highly immunocompromised population for enrolment in this trial. Additionally,~     the immune system's response (protection against smallpox as measured by the amount of~     antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All~     participants in this trial will be randomly and evenly assigned to one of three groups to~     receive two, three or four injections. Group 1 will receive the standard regime consisting~     of one dose at each vaccination time point, Group 2 will receive two doses at each~     vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the~     first dose of the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation~     in the trial is scheduled to last up to 48 weeks.~   "
77813|NCT02038868|"~     The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients~     with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be~     evaluated.~   "
77814|NCT02038855|"~     Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for~     Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and~     intervention project designed to improve the quality of care for Latino patients with~     comorbid mental health and substance use problems. We will first test a screening of~     comorbid problems with patients identified in mental health as well as primary health care.~     Building on that work, we will test the feasibility, acceptability and efficacy of the~     Integrated Intervention for Dual Problems and Early Action (IIDEA) intervention addressing~     mental health, substance use, and prevention of HIV, as well as a smoking cessation~     supplement. The project is being conducted in Massachusetts as well as at two sites in~     Spain. As such, the proposed ILRP multi-site international project is a critical step~     towards developing models of integrated care for the large and diverse Latino migrant~     population and more broadly towards understanding how best to integrate evidence-based~     assessment and treatments for co-occurring substance and mental health problems and HIV~     risks.~   "
77815|NCT02038842|"~     The development of a safe and effective HIV-1 vaccine strategy would probably be the best~     solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost~     immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus~     relevant to pursue the development of different candidate vaccines in prime-boost vaccine~     strategies to identify the most promising prime-boost combinations and to integrate~     scientific inquiry into trial protocols from the beginning to maximize learning~     opportunities.~   "
77816|NCT02038829|"~     Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD.~     Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.~   "
77817|NCT02038816|"~     Myelodysplastic syndromes are common blood disorders that can affect as many as one in 1000~     Canadians over the age of 65. They are characterized by low blood counts that require~     frequent blood transfusions. The development of iron overload in these patients is~     inevitable. The iron deposits in vital organs such as the heart and the liver and can lead~     to organ dysfunction. Deferasirox is a well-studied drug that helps remove iron from the~     body. Most people with this disorder die due to progression of their disease to acute~     leukemia through multiple mechanisms. Iron overload in patients with myelodysplastic~     syndromes has been shown to be associated with shorter survival, and potentially a higher~     chance of leukemia. In a certain subgroup of higher risk patients, the drug azacitidine has~     been shown to decrease the chance of progression to leukemia and death from it. Thus, it is~     presently the standard of care for these patients. However, 50% of higher risk patients are~     still unresponsive to this medication, leaving a large group of patients for which other~     treatment options are emergently needed. Given that a large proportion of higher risk MDS~     patients fail to respond to azacitidine, and the evidence that iron deposition may lead to~     increased leukemic transformation, we would like to study whether iron removal from the body~     with deferasirox potentiates azacitidine in its effects on overall survival, as well as the~     chance of leukemia transformation. This question needs to be addressed in a randomized~     controlled trial, and the first step is a preliminary study to determine if the combination~     of azacitidine and deferasirox has any biologic effect. This study will determine whether~     this combination leads to blood count improvement over azacitidine alone. If this drug~     combination ultimately proves more useful than azacitidine alone with respect to survival,~     this has the potential to impact the care of a large proportion of patients with~     myelodysplastic syndromes.~   "
77818|NCT02038803|"~     Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for~     individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway~     colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations~     of CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately,~     the standard nebulizer method for delivering tobramycin inhaled solution (TIS) is~     time-consuming and may result in missed therapy doses and suboptimal care. A new inhaled~     formulation and delivery device, the TOBI Podhaler (TPI), is a quicker, more efficient~     method of administering inhaled Tobramycin. This new pocket-sized disposable inhaler is~     maintenance free, requires no refrigeration or power source, and should greatly increase~     patient mobility and improve time management.~   "
77819|NCT02038790|"~     The primary objective of this study is to compare overall patient preference for either~     Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual~     film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7~     mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate~     drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period~     of time.~   "
77820|NCT02038777|"~     This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients.~     PF-04449913 will be administered orally as a single agent in patients with select advanced~     hematologic malignancies, or in combination with LDAC [Low-Dose Ara-C] or cytarabine and~     daunorubicin in previously untreated patients with AML [Acute Myeloid Leukemia] or high-risk~     MDS [Myelodysplastic Syndrome].~   "
77821|NCT02038764|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.~   "
77833|NCT02038608|"~     Parkinson's disease is characterized by a large number of non motor, especially~     neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and~     serotoninergic systems dysfunction is suggested by several studies. In addition, the~     serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies~     have analyzed the abnormalities of these two neurotransmission systems at disease onset, in~     de novo PD patients. Furthermore, the parallel evolution of the degeneration of the~     dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the~     present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective~     role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor~     manifestations in PD, at different evolution stages.~   "
77822|NCT02038751|"~     The growing evidence showed that the OSA is a heritable complex genetic disease where the~     genetic basis contributed the development of OSA and its sequel. The phenotyping of OSA~     include high level and intermediate level. The former indicates the AHI, and later includes~     craniofacial morphology, ventilator control, obesity, and sleepiness vulnerability.~      Many studies tried to determine the association of candidate genes with OSA through~     association studies. However, the results were conflicting. We identified 37 candidate genes~     involved in six biologic pathways of OSA reported in previous literatures, including~     oxidative phosphorylation, cell signaling, apoptosis, cellular adhesion and motility, cell~     cycle, and cytokine/chemokine.~      To investigate the association between phenotype and genotype of OSA, we conducted this~     cross-sectional study by recruiting the patients of moderate-severe OSA (index proband) and~     their first and second-degree family members, and friends and their family members (control~     family) and using candidate genes reported in the literature and whole genome SNP array for~     genotype approach.~   "
77823|NCT02038738|"~     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging.~     The 68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and~     resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will~     be imaged with this agent and it will be compared to conventional imaging methods to~     determine the safety and efficacy of this radiopharmaceutical.~   "
77824|NCT02038725|"~     Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment~     and treatment can reduce the risk. Several international guidelines recommend a test, the~     ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of~     this study is to investigate stroke risk after TIA in both short (1 week) and long term (3~     months/1 year), and to assess whether the Age, Blood pressure, Clinical features, Duration~     of TIA, Diabetes (ABCD2) score is a sufficient tool for predicting stroke risk. Secondary~     aims are to explore whether adopting imaging modalities (ultrasound, MRI) and biological~     markers of blood into a risk score could improve the predictive value of the ABCD2 score and~     still be feasible in a daily clinical practice. Further on overall risk factors in TIA~     patients, and the incidence of other vascular events will be studied. A substudy designed as~     a randomised controlled trial evaluates pharmaceutical counseling in a subset of~     participants. Cost-benefit analysis, and a long-term follow-up (5 years) is planned.~   "
77825|NCT02038712|"~     Binge Eating Disorder (BED) may be associated with he development of obesity. However, the~     pathogenesis of BED is currently unclear, thus making the development of treatment and~     prevention strategies for BED difficult. Differences in the mechanisms regulating food~     intake may go some way to reveal potential mechanisms for BED.The purpose of this study is~     to investigate the responses of key gut-derived hormones that are associated with the~     regulation of food intake and functional brain activity to food cues using fMRI in BED~     patients and weight matched controls.~   "
77826|NCT02038699|"~     ONC201 is a new potential drug that kills cancer cells but not normal cells in laboratory~     studies. This clinical trial will be the first evaluation of ONC201 in humans and will~     enroll patients with advanced cancer. This trial includes a phase I portion that will~     evaluate the safety of ONC201 and the recommended dose for the phase II portion. The phase~     II portion will evaluate the initial efficacy profile of ONC201 in select types of cancer.~   "
77827|NCT02038686|"~     1. Introduction:~           Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma~          Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an~          intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial~          is performed to compare the outcome treatment of these unstable fractures of the~          proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A~          (300-420mm).~        2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer~          complications than Long PFN-A~           Main Objective: Is defined as Total number of complications between PFN-A short and~          PFN-A long. Outcome measures were subdivided into preoperative, perioperative and~          post-operative. Follow up data at four weeks, three months and one year.~           Secondary objectives: Complete and uneventful radiological and clinical healing of the~          fracture. Revision operations (related to the failure of primary treatment) and~          mortality. Baseline characteristics were documented pre-operatively: Outcome measures~          were subdivided into intra-operative, post-operative and follow up data at four weeks,~          three months and one year.~        3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and~          31-A3 fracture of the proximal part of the femur will be randomized, at the time of the~          admission, to fixation with use either a short PFN-A or a long PFN-A.~   "
77828|NCT02038673|"~     The objectives of this study are to determine the tolerability, safety, pharmacokinetics~     (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in patients with solid tumors.~   "
77829|NCT02038660|"~     The purpose of this study is to evaluate long-term effectiveness and safety of patients with~     coronary disease treated with drug eluting balloon in real world practice.~   "
77830|NCT02038647|"~     This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study~     designed to evaluate the efficacy and safety of alisertib, an Aurora A kinase inhibitor, in~     combination with paclitaxel compared with placebo + paclitaxel in patients with SCLC who~     have relapsed or did not respond to first line standard therapy.~   "
77831|NCT02038634|"~     The investigators aim to perform a prospective study to evaluate the effectiveness of blind~     corticosteroid injections to US-guided injections for the treatment of de Quervain's~     disease. The results of the study will be used to validate current injection protocols or~     support the incorporation of ultrasonography to treat the disease.~   "
77832|NCT02038621|"~     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of~     advanced gastric cancer (AGC)~   "
77834|NCT02038595|"~     This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing~     the norepinephrine transporter.~   "
77835|NCT02038582|"~     The purpose of this study is to determine efficient, scalable, evidence-based strategies to~     link HIV positive individuals to care and HIV negative individuals to prevention measures,~     such as voluntary male circumcision.~   "
77836|NCT02038569|"~     An international, multi-centre, prospective, non-controlled, open, single-group, 8-week~     trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.~   "
77838|NCT02038543|"~     Primary hyperoxaluria is an inborn error of metabolism that results in marked overproduction~     of oxalate by the liver. The excess oxalate causes kidney failure and can cause severe~     systemic disease due to oxalate deposition in multiple body tissues.~      Metabolic pathways that lead to oxalate are poorly understood, but recent evidence suggests~     that hydroxyproline may play a role. Sources of hydroxyproline include the diet and bone~     turnover. If hydroxyproline can be confirmed as a signficant factor in primary~     hyperoxaluria, diet modification might be of value in reducing the severity of disease.~      This protocol, in which hydroxyproline labelled with a cold isotope is infused intravenously~     in patients with primary hyperoxaluria, will allow us to measure the amount of oxalate~     produced from hydroxyproline. The contribution of hydroxyproline metabolism to the amount of~     oxalate excreted in urine in will be able to be determined for patients with each of the~     known types of primary hyperoxaluria.~   "
77839|NCT02038530|"~     This is a cohort study that will assess a new diagnostic management strategy for suspected~     Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the~     use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a~     week after an initial normal test.~   "
77840|NCT02038517|"~     This observational study is aimed at assessing insulin secretion and sensitivity by the use~     of a mathematical modeling from oral glucose tolerance test in subjects with liver cirrhosis~     undergoing orthotopic liver transplantation (OLT), before and at various time points after~     OLT.~   "
77841|NCT02038504|"~     The purpose of this study is to investigate whether enteral nutrition are effective in the~     treatment of nonthyroidal illness syndrome among fistula patients.~   "
77842|NCT02038491|"~     Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns~     remain about possible adverse effects and complication.~      RICALOR Group Investigators developed a national registry to register the incidence of~     regional anesthesia-associated complications and to identify possible risk factors.~   "
77843|NCT02038478|"~     The design of the study incorporates the following features:~        1. This is a phase II study to determine the safety and therapeutic potential of a new~          transplant approach (disease-free survival, graft versus myeloma effect) and to~          evaluate its toxicity profile (immediate toxicity, graft-versus-host disease, graft~          rejection, mortality) in a patient population with severe congenital anemias.~        2. The patient cohort to be studied: Those patients with severe sickle cell disease and~          thalassemia who have risk factors for high mortality and morbidity related to their~          disease~        3. Transplant Conditioning Regimen - Immunosuppression without myeloablation: Patients~          will receive conditioning sufficient to allow donor lympho-hematopoietic engraftment~          without complete marrow ablation. If the graft is rejected, the patient will~          reconstitute autologous marrow function. We will use a combination of low dose~          irradiation, Alemtuzumab (Campath®), and sirolimus.~        4. Peripheral blood hematopoietic progenitor cell (PBPC) transplant: An unmanipulated~          peripheral blood stem cell collection from a filgrastim (G-CSF) stimulated HLA-matched~          donor should improve the chance of engraftment because of the high stem cell dose (5 x~          106/kg CD34+ cells) and the presence of donor lymphocytes. To reduce the risk of GVHD,~          patients will receive sirolimus before and after the transplant. The sirolimus will be~          tapered as necessary to minimize any graft versus host disease while still maintaining~          adequate chimerism.~   "
77844|NCT02038465|"~     The aim of the study is to assess the efficiency of SenseCam® in patients with schizophrenia~     by comparing two cognitive remediation methods of autobiographical memory.Patients and~     control participants will be invited to carry SenseCam® during 7 hours per day minimum and~     for 4 successive days. Each ending day when carry SenseCam®, they will be asked to go to the~     laboratory where 4 types of interventions will be successively done according to the~     randomization: 1) a simple visual retrospective procedure (SVR), 2) a visual retrospective~     procedure coupled with a specific cueing intervention (VR-SC), 3) a verbal retrospective~     (VbR) and 4) no intervention (control condition).The testing phase will take place 14 days~     after the last day of data collection and will consist in a cued recall task and a~     recognition task using the pictures obtained by the SenseCam® of the participants.According~     to our hypotheses, the vividness of memories will be higher in events subjected to the VR-SC~     procedure than in events subjected to the SVR and VbR procedures. This effect is expected~     for both patients with schizophrenia and controls participants. Since strategies to enrich~     memory details will be explicitly given to the patients when using the VR-SC procedure, we~     assume that patients will be able to normalize their scores.~   "
77845|NCT02038452|"~     Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median~     nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling~     or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day~     things.~      There have been several studies into the best treatment of patients with severe symptoms of~     CTS who are referred to a hospital for treatment. However, little is known about the best~     treatments for patients with mild to moderate symptoms who visit their GP but do not require~     hospital treatment.~      The study will investigate whether a steroid injection is clinically effective in reducing~     symptoms and improving function in the short term (6 weeks) compared to a night splint in~     people consulting with mild to moderate CTS in primary care.We will study the effects of~     these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will~     also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.~      The study will take place in up to 50 GP practices and hospital clinics across the UK.~     Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been~     present for at least 6 weeks will be eligible for inclusion.~      The steroid is a drug called DepoMedrone. This drug is already widely used to treat CTS.~     In this study, one injection will be given. The splint is made of elastic and has an~     aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at~     night for 6 weeks. Each participant will receive either a single steroid injection or a~     splint, and will be asked to complete up to 5 questionnaires over 2 years.~   "
78001|NCT02036424|"~     To determine if there is visual benefit with Ozurdex treatment every three months compared~     to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The~     investigator hypothesizes more frequent administration of Ozurdex in patients that have~     persistent diabetic macular edema will result in a more rapid and sustained improvement of~     visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF~     alone.~   "
77846|NCT02038439|"~     Translation of new knowledge from research into evidence-informed health care is a shared~     obligation of the clinical and the scientific communities. Unfortunately, studies of quality~     of care continue to show that this goal is substantially unrealized. One main barrier is~     lack of quick and easy identification, appraisal and synthesis of current best evidence.~     Clinicians' information have 5 to 8 questions about individual patients per daily shift, but~     face a large volume of 3000 articles published every day, accessible in many scattered~     resources.~      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,~     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search~     (MPFS), an online search engine that provides a unique 1-stop search and organized access to~     current best evidence in daily practice. However additional barriers need to be overcome for~     clinicians to actually search and use this evidence in their practice. Theses include~     logistical barriers (time constraints, forgotten questions), as well as educational barriers~     (eg, lack of awareness of the architecture of evidence, limited searching skills, and lack~     of reference standards among peers for finding best evidence).~      This randomized trial seeks to test 3 innovative online interventions among clinicians~     registered to MPFS to overcome these barriers and increase the quantity and quality of~     searching for current best evidence to answer clinical questions. These interventions build~     on effective models for the teaching of clinical skills at the point of care, so that~     clinicians are facilitated in using the search engine as a clinical tool, and perceive~     evidence retrieval skills as true clinical skills.~   "
77847|NCT02038426|"~     Purpose:~        -  Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy~          subjects, athletes or not~        -  Comparison of the ultrasound semiology of enthesitis in the 3 populations~        -  Comparison of the MASEI scores in the 3 populations~   "
77848|NCT02038413|"~     Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the~     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring~     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than~     that of conventional radiotherapy (RT) with photons, it is necessary to establish whether~     these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence~     of the situations in which PT outperforms conventional photon treatment is needed.~      In a previous ROCOCO study (lung stage I-IIIB) an inhomogeneous group of patients with~     regard to tumor stage and size was included1. Conformal radiotherapy and Intensity Modulated~     Radiotherapy were used in the comparison. In this study patients with smaller tumors are~     included (stage I). A stereotactic treatment schedule and more advanced treatment~     techniques, such as CyberKnife, RapidArc, IMRT and Tomotherapy, are eligible for these kind~     of lesions. As a result the comparison as demonstrated in our previous study maybe invalid.~     We propose to investigate to what extend proton and 12C-ion therapy decrease the amount of~     irradiated normal tissue compared to state of the art photon modalities in stage I lung~     cancer patients.~   "
77849|NCT02038400|"~     Otitis media are the consequence of bacterial infection. They are characterized by middle~     ear inflammations with a collection of fluid behind the eardrum. The effusion stagnates in~     the middle ear, can increase acute infection and induce tympanic membrane and inner ear~     damages. Delay in language learning can be observed in affected children as well as hearing~     problems e.g. constant hearing loss. The two main forms of chronic otitis are otitis media~     with effusion (OME) and atelectasis with or without retraction pockets.~      To date, insertion of tympanic ventilation tubes (tympanostomy) is the most effective~     treatment for otitis media with effusion that has failed to respond to conservative drug~     treatments; and for delaying the progression of serious atelectasis. When a first tube did~     not allow complete recovery, recurrence is then observed and insertion of new tube is~     needed. The repeated tube insertions increase risks linked to general anesthesia and~     increase rate of sequelae/complications, such as tympanic membrane perforation.~      Kinetube® is a CE-marked medical device, marketed in France and Europe since April 2002.~     This device improves the neuronal control mechanism of the pharyngotympanic (Eustachian)~     tube, regulating middle ear pressure. This could be an alternative for patients having~     recurrence and needing repeated tube insertion, as studies had shown that Kinetube® improved~     the opening of the Eustachian tube in patients with otitis media with effusion (OME) and~     atelectasis.~      These previous clinical studies have shown the feasibility of the use of Kinetube® in~     clinical practice. A larger clinical study with a high level of evidence must be performed~     to show therapeutic efficacy of the Kinetube® in chronic otitis compared to ventilation tube~     insertion.~   "
77850|NCT02038387|"~     Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are~     characterized by a spectrum of pathological conditions ranging from an early stage of~     inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular~     carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large~     differences in age and ethnic groups, while it is well known that HCV infection is a major~     cause of chronic liver disease in Western countries.~      For both diseases the progression of liver damage is in close correlation with the lifestyle~     of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was~     shown that feeding imbalances may have implications in altering the normal immune functions~     of the subjects, suggesting that the metabolic and the immune systems are closely related to~     each other. Although it is well known the negative role of obesity on the progression of~     NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to~     the immune response is not yet fully understood. Insulin resistance, altered lipid~     metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are~     pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV~     infection.~      Recent studies suggest that the evolution of viral infections and chronic inflammation in~     NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17~     (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV~     infection in the activation of Th17 cells and in the alteration of some of their functions,~     will allow to shed light on the pathogenic mechanisms underlying the progression of~     immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17~     cells may have a role in the diminished response to therapy in patients who have high~     cholesterol levels.~      If the results will confirm our hypothesis, this study will provide useful informations for~     the clinical management of patients with both steatosis and chronic HCV infection. The data~     obtained can also be used for the development of new therapeutic strategies directed to~     modulate the antiviral immune response.~      All patients will undergo clinical and instrumental assessment depending on the type of~     pathology. Patients will be required to follow a normocaloric low cholesterol diet for a~     period of 30 days.~      The prospective clinical study does not present any form of additional risk for the patients~     and will be conducted in accordance with the principles established by the Declaration of~     Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require~     any additional costs.~   "
77905|NCT02037672|"~     The purpose of this study was to determine whether combined treatment with~     phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than~     metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome~     (PCOS) who had been previously poor responders regarding weight reduction on metformin~     monotherapy. The investigators anticipated greater changes in body weight in patients on~     combined treatment than in those on monotherapy with metformin.~   "
77851|NCT02038374|"~     Asthma is the most common chronic respiratory disorder in children. Despite significant~     advances in understanding of asthma, available therapies fail to alter the natural history~     and progression of the disease. Airway epithelial cells are continuously exposed to and~     injured by environmental irritants, such as viruses and pollutants, and as such are ideally~     situated to orchestrate airway function in response to these stimuli.~      Severe or difficult-to-treat asthma in children is a complicated disorder characterized by~     ongoing symptoms and persistent airway inflammation and oxidant stress despite~     corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder,~     affected children similar clinical features, including gas trapping, bronchial~     hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular~     pattern of inflammation in children with severe asthma are not uniform : some investigators~     have found increased eosinophils and TH2 derived cytokines, others have noted~     noneosinophilic patterns with neutrophil activation.~      Given the heterogeneity of the inflammatory response in children with severe asthma,~     additional methods to distinguish severe asthma are needed.~   "
77852|NCT02038361|"~     Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal~     proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid~     lineage. The repertoire of mutations that determine the leukemic transformation, complex and~     variable depending on the tumor type and progression of the disease, combined in the same~     cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic~     abnormalities.~      The project presented here is part of a comprehensive approach to diagnosis of hematologic~     malignancies of children. Using comparative genomic hybridization on microarray (or array-~     CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive~     analysis of the genome and transcriptome , offer new perspectives identifying molecular~     defects . These techniques provide new elements in the identification of acute leukemia at~     diagnosis may identify new prognostic factors to optimize the care of patients.~      This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the~     identification of genomic abnormalities associated with childhood leukemia , the Laboratory~     of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the~     phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department~     (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow~     of children with hematologic malignancies . The following project is mainly focused on the~     identification of genomic abnormalities (deletions and duplications) and abnormalities in~     gene expression to identify a genetic profile ensuring a better classification within the~     different groups risk .~      The project we propose is centered on the identification of genomic abnormalities , changing~     the number of copies of certain regions of the genome or determining loss of heterozygosity~     , and the identification of changes in the level of gene expression by using two analytical~     techniques, comparative genomic hybridization on microarray (or array- CGH) and expression~     studies with microarrays . The data generated will , for the identification of  molecular~     signatures  , the classification of patients according to prognosis , variations in~     treatment response and survival.~      The originality of this project lies in the use of these new tools in the diagnosis of~     hematological malignancies in children. This pilot study will be conducted with commercial~     Affymetrix , will develop the chips ' processing' , dedicated , enriched probes~     corresponding to genes involved in leukemogenesis , with high discriminatory power in~     identifying these signatures.~      The data published in the specialized literature from the study of large series of patients~     show that microarrays provide important information for the diagnosis and therapeutic~     management of patients. It is for this reason that in the end we hope to integrate these~     analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of~     fusion genes and sequencing) in order to further characterize the abnormal cells leukemia~     and establish an  identity card of leukemia .~   "
77853|NCT02038348|"~     Melanoma incidence is increasing in most developed countries. At the metastatic stage, the~     prognosis is usually poor. Major advances have been obtained over the last 3 years with the~     development of therapies targeting the MAP kinases pathway.~      Vemurafenib (zelboraf®) is approved in France since 2012 as first treatment of metastatic~     melanoma carrying a B-RAF mutation.~      For growth, the tumor needs an adequate supply of nutrients to allow the synthesis of~     macromolecules and a contribution in carbon elements to ensure the production of energy. The~     nutrition demand is met through greater availability of nutrients via tumor angiogenesis and~     through increased intracellular penetration of nutrients via specific upregulation of~     transport systems and metabolic pathways.~      Scanner is the imaging method most commonly used for the evaluation of therapeutic response.~     Such a method gives a morphological indication but does not evaluate the metabolic response.~      With the development of functional imaging techniques and the advent of positron emission~     tomography (PET), it is now possible to obtain an assessment of the metabolic activity of~     tumors. The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly~     recent. The advantage of this approach is well documented for GIST and non-small cell lung~     cancer. In melanoma, the metabolic response to 18F-FDG is much faster than the response to~     TAP scanner.~      18F-FDG tracer that targets glucose metabolism, is the most sensitive functional imaging in~     melanoma, which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT.~     The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease, a~     situation in which it can replace the TAP scanner, additional brain imaging remaining~     necessary.~      The use of metabolic imaging to study the response to targeted therapies in melanoma has~     been the subject of only one publications. There was a trend toward improved~     progression-free survival in patients with high metabolic response at day J15.~      For melanoma, the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG (64%~     versus 95%). In contrast, the 18F-FDOPA tracer has the advantage of allowing a brain~     assessment, which is critical in melanoma that gives frequent metastases in the central~     nervous system. There has never been any evaluation of the metabolic response to targeted~     therapies such as BRAF inhibitors PET with 18F-FDOPA.~      The investigators propose to conduct a monocentric prospective preliminary study to explore~     the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of~     metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib.~   "
77854|NCT02038335|"~     This study is being done to understand if using birth control causes changes in the immune~     cells within the reproductive tract of healthy women. Immune cells are important because~     they help prevent infections from starting and help fight infections that have started.~     Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so~     understanding more about them will help to better understand how to prevent the spread of~     HIV.~      Immune cells will be studied from the reproductive tract of women who want to start using~     one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the~     levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon®~     or Nexplanon® ) and the copper IUD.~   "
77855|NCT02038322|"~     This is a clinical study designed to validate the usability and safety of the~     over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease~     of use of The Stork™ Conception System and the instructions for use. In addition to~     usability, results for safety, including vaginal~   "
77856|NCT02038309|"~     Study of persistent platelet reactivity during acute coronary syndrome. Patients are~     included at admission to the hospital. Platelet aggregation is evaluated by platelet~     function testing after blood sampling during hospitalization. No changes in treatment is~     planned.~   "
77857|NCT02038296|"~     To evaluate local tumor control and survival rate after repeated transarterial~     chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC)~     patients.~   "
77866|NCT02038179|"~     We propose a novel intervention for reducing BP that could have a preferential impact in~     patients with hyperuricemia and gout. There is a great need for new anti-hypertensives,~     particularly among those with gout. The proposed study is novel in its plans to investigate~     the physiologic mechanisms through which urate contributes to vascular disease and by which~     ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent~     the described benefit of lowering serum urate extends beyond the adolescent population~     previously studied into young adults, 2) test whether a urate-lowering approach will benefit~     individuals that do not yet meet the current definition of hyperuricemia and do not have~     gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension~     among African-Americans. If successful, this work could translate to the standard of~     clinical care and to health care recommendations for the population as a whole.~   "
77858|NCT02038283|"~     Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong~     Kong and the second leading cause of cancer death in this population. Several screening~     strategies has been associated with improved survival and may affect patients'~     health-related quality of life (HRQOL). HRQOL impact should be used to adjust for survival~     in terms of quality adjusted life years (QALY) in the evaluation of cost-effectiveness of~     any intervention including screening.~      Objectives: to determine the HRQOL and health preference of patients with different stages~     of colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for~     increasing QALYs.~      Design and Subjects: A longitudinal survey to collect data on HRQOL associated with~     colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified~     sample of 420 patients with colorectal polyps and different stages of CRC will be recruited~     from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment.~     The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference~     data will be integrated with cost and effectiveness data obtained from the literature to~     determine the cost-effectiveness of currently recommended CRC screening strategies by Markov~     modeling.~      Main outcome measures: The primary outcome measure is the SF-6D health preference value and~     QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared~     between patients with different stages of colorectal neoplasm. Markov modeling study will~     estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC~     screening strategy.~      Results: The study will provide information on HRQOL of patients with colorectal neoplasm to~     guide health services. The Markov Model will identify the most cost-effective CRC screening~     strategy for Hong Kong Chinese, which can inform policy makers and the public for the~     prevention of CRC of the population.~   "
77859|NCT02038270|"~     The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff~     manometer, combined with NIRS technology. The accuracy of the signal is dependent on the~     degree of vascular unloading, which takes an period before optimal unloading is reached. The~     evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the~     absolute and relative inaccuracy of the nexfin as a function of the time is determined~     compared to the invasive blood pressure (IBP).~      Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of~     noninvasive blood pressure to predict the IBP.~   "
77860|NCT02038257|"~     The purpose of this study is to:~        1. Compare two different techniques in the melanocyte keratinocyte transplant procedure:~          Use of carbon dioxide laser versus use of dermabrasion~        2. Compare two different dressings in the melanocyte keratinocyte transplant procedure:~          vaseline impregnated gauze versus collagen dressing~   "
77861|NCT02038244|"~     In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for~     integrative medicine on pain, disability, quality of life, satisfaction with life,~     depression, and anxiety will be investigated. Furthermore the influence of potential process~     variables will be evaluated.~      Effects will be measured after completion of the program (2 weeks), and at 6 months follow~     up after start of the program.~   "
77862|NCT02038231|"~     The goal of study is to develop and test a parenting-focused version of mindfulness~     intervention (Parenting Mindfully) to reduce parent stress and prevent adolescent~     substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that~     Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk~     behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent~     stress responses.~   "
77863|NCT02038218|"~     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated~     antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and~     glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings~     support the preclinical responses seen in mice bearing intracerebrally implanted human~     breast and GBM tumor xenografts. Toxicity was acceptable - hyperbilirubinemia (in patients~     with liver disease and/or liver metastasis). No hematological, renal, cardiovascular,~     behavioral or cognitive impairment/neurotoxicities were noted during the Phase I human trial~     or in previous pre-clinical studies.~      The drug is available for use as a soy bean oil/egg yolk lecithin/glycerin water emulsion;~     the latter continues to be chemically and biologically stable and safe.~      Patients with advanced lung, breast and melanoma cancers spread to the CNS and primary CNS~     malignancies will be eligible for enrollment and treatment, providing the required blood and~     other eligibility requirements are met. The trial will be 2-tiered - patients with liver~     involvement vs. non-liver involvement will be treated with different doses of the drug.~      The trial is open and patients are currently being enrolled and treated with the protocol.~   "
77864|NCT02038205|"~     A prospective cohort follow-up study design is undertaken. Both males and females with mild~     to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks~     and undergo follow up studies for data collection. Controls will also be seen for a one time~     visit.~   "
77865|NCT02038192|"~     Hope is important for family/friends of persons with dementia residing in Long Term Care~     Facilities. Our research team has developed a program (Living with Hope) to increase hope~     and quality of life of family caregivers. The Living with Hope Program involves a) viewing~     the Living with Hope film which features caregivers of persons with dementia describing~     their hope and b) a hope activity entitled Stories of the Present. A new Living with Hope~     film entitled Connecting with Hope has been produced and will be used in this pilot study.~     The purpose of this pilot study is to evaluate the feasibility and acceptability of the~     Living With Hope Program and collect preliminary data on the effectiveness of the Living~     with Hope Program for family members of persons with dementia residing in Long Term Care.~      30 participants will be recruited from St. Joseph's Auxiliary hospital, the Alzheimer's~     Society of Alberta, and the Alberta Caregivers Association in Edmonton based on inclusion~     criteria. Participants will be randomly assigned to one of three groups: treatment (Watching~     a film on hope and Stories of the Present for one month); low dose group (Stories of the~     Present only); or usual care group. In all groups measures of hope, quality of life,~     self-efficacy and guild will be collected at visit 1, day 7, day 14 and one month in~     addition to demographic information. Participants in group 1 and 2 (treatment group) will be~     asked to describe what they were thinking about when doing the hope activities on day 7, 14~     and one month using qualitative interviews. At one month all participants will be~     interviewed using open ended audio-taped questions to help evaluate the study procedures~   "
77867|NCT02038166|"~     The purpose of this study is to determine if acquired (partial) Cystic Fibrosis~     Transmembrane Conductance Regulator (CFTR) deficiency contributes substantially to the~     pathogenic mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized~     environment that impairs mucociliary clearance (MCC).~   "
77868|NCT02038153|"~     This phase I/II trial studies the side effects and best dose of lenalidomide and how well it~     works in treating older patients with acute myeloid leukemia who have undergone stem cell~     transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing.~   "
78002|NCT02036411|"~     100mg clomiphene citrate used for ovulation induction. The investigators take blood sample~     at 3 and 10 days of menstruation and count AMH and inhibin B.~   "
77871|NCT02038114|"~     This study will test the impact of newly created and available symptom management patient~     education brochures on symptom burden [measured via the Edmonton Symptom Assessment System~     (ESAS)], health-related quality of life [measured by the European Organisation for Research~     and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction~     with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire~     (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient~     Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and~     knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are~     designed for oncology patients in order to provide a response to symptom screening and are~     now a standard part of care. Symptom screening occurs at each visit as patients are required~     to fill out ESAS, that asks about their experience with the occurence and severity of~     symptoms. The intent of the patient brochures are to acknowledge the screen, validate the~     symptom and provide knowledge of self-management strategies for symptoms. The brochures also~     provide information to patients about when and how to seek further help from their oncology~     team. The hope is that patients will experience a useful response to their screen with all~     levels of symptoms-from 0-10 in severity~      It is hypothesized that the addition of patient education symptom management pamphlets on 7~     of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety,~     fatigue, dyspnea and pain) will provide new and meaningful information which will build~     knowledge, validate the patient's experience of the symptom, lead to increased satisfaction~     with care, improved self efficacy in managing and accessing help for the symptom and~     therefore improved health related quality of life.~   "
77872|NCT02038101|"~     This study is an international, prospective, multi-centred, investigator blinded, randomized~     control trial of an educational and feedback-based intervention vs. usual care to study the~     proportion of inappropriate TTEs ordered by clinicians in ambulatory care.~      The American College of Cardiology collaborated with the American Society of~     Echocardiography to develop its Appropriate Use Criteria (AUC) for Echocardiography in 2007,~     and were updated in 2011.~      We created an innovative education and feedback-based intervention that we hypothesize will~     reduce the proportion of inappropriate TTEs ordered in clinical practice. Our objective is~     to prospectively study the following intervention in a multicentre, randomized control trial~     format to determine if this intervention will reduce inappropriate TTEs and the number of~     TTEs ordered in practice.~      The study will take place at multiple hospitals in Canada the United States. Participants~     include cardiologists and primary care providers (both general internal medicine and family~     practice) who provide ambulatory care.~      Once cardiologists and primary care physicians are recruited for the study, they will be~     randomized into one of two arms: 1) Intervention group, 2) Control group.~      A physician's TTE ordering information will be ascertained by review of the individual TTE~     order and by review of the patient's medical record. Trained research coordinators at each~     site will review the TTE order for indication and review the patient record to ascertain~     clinical circumstances regarding the TTE order. The individual research coordinator will~     review this information using the 2011 AUC and classify the TTE as Appropriate (A),~     Inappropriate (I) or Uncertain (U), and assign the TTE order the most appropriate indication~     number accordingly. Research Coordinators will be blinded to which physicians are in the~     intervention or control group.~      Research Coordinators at each site will be responsible for individual physicians' TTE order~     classifications but will be blinded to study group. Once monthly TTE orders are classified~     and collated, this information will be transmitted to the central research laboratory, where~     a research coordinator will collate all of the results and transmit monthly feedback reports~     to individual physicians. The control group will order TTEs as is their usual practice.~   "
77873|NCT02038088|"~     The purpose of this study is to determine whether the general anesthesia immunosuppressive~     could effect hepatitis B Virus replication~   "
77874|NCT02038075|"~     The primary purpose of this study is to compare the effectiveness of brief~     cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal~     ideation and attempts (regardless of Axis I or II diagnosis) among active duty military~     personnel. The standard null hypothesis will involve tests conducted comparing improvement~     following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary~     outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide~     attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation,~     intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along~     with remission of psychiatric diagnoses. Secondary purposes include the prospective~     investigation of suicide risk factors and warning signs to explore these variables' ability~     to predict subsequent suicidal behavior following an index attempt.~   "
77875|NCT02038062|"~     Ischemic preconditioning is defined as protection from cell damage induced by prolonged~     ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce~     ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective,~     randomized pilot study is investigated if clamping of the femoral artery leads to ischemia~     of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of~     sevoflurane preconditioning on ischemia of the calf is measured.~   "
77876|NCT02038049|"~     The aim of this study is to determine if a monoclonal antibody VAY736 can reduce disease~     activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo. The study~     will also provide the first safety and tolerability information for VAY736 in RRMS patients.~   "
77877|NCT02038036|"~     This trial will compare the efficacy and safety of ruxolitinib to Best Available Therapy~     (BAT) in patients with polycythemia vera (PV) who are hyroxyurea (HU) resistant or~     intolerant and do not have a palpable spleen.~   "
77878|NCT02038023|"~     To determine the percentage of women who achieve anemia correction after a single dose of~     1000mg of low molecular weight iron dextran(infed).~   "
77879|NCT02038010|"~     The purpose of this study is to see whether a combination of two different drugs -~     trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating~     metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab)~     linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called~     HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this~     study is considered standard treatment for the type of cancer in this study. Participants in~     this study have already been treated with trastuzumab and chemotherapy in the past, and~     their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by~     mouth) that the researchers think may help T-DM1 to work better.~   "
77880|NCT02037997|"~     The purpose of this study is to evaluate and compare safety and effectiveness of~     Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients~     With EGFR - TKI Resistance of EGFR Mutations~   "
77881|NCT02037984|"~     This study is designed to assess the effect of different dose levels of pneumococcal~     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and~     infants.~   "
77882|NCT02037971|"~     The purpose of this study is to determine the effectiveness of exercise training on~     improving sleep in patients with systemic lupus erythematosus.~   "
77883|NCT02037958|"~     We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and~     reduced haemodynamic variability during insertion compared to the tracheal tube, whilst~     still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in~     selected patients.~   "
77884|NCT02037945|"~     The main purpose of this study is to determine the distribution of 18F Fluorocholine~     (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor~     regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if~     applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.~   "
77887|NCT02037906|"~     Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal~     and ureteral calculus disease. In vitro studies suggest that progressive increase in~     lithotripter energy output voltage could produce the best overall stone comminution in~     comparison with constant or deescalating energy output. However, it is possible that the~     beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked~     any marginal benefits for energy output escalation. The Escalating SW method adds the~     benefit of less renal tissue injury.~      Research Significance:The present study will signifies and evaluates the stone free rates of~     three groups of patients with renal stones treated with different SWL energy outputs~     (Escalating, Constant and Reduction energy output).~      Research Objectives: The aim of this research project is to study the effect of dose~     adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and~     to optimize the conditions for successful Shock Wave Lithotripsy.~      Research Methodology: This clinical trial will be conducted at a tertiary care university~     hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for~     eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant~     dose). Parameter of the three groups will be compared to detect the treatment difference.~   "
77888|NCT02037893|"~     The primary objective is to compare the effect of treatment with a combination of ear~     solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute~     otitis media.~   "
77889|NCT02037880|"~     The purpose of this study is to assess rates of decline in motor and cognitive functional~     measures, and to assess potential biomarkers, in order to identify potential outcome measure~     appropriate for use in therapeutic clinical trials.~   "
77890|NCT02037867|"~     Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver~     disease is now the 3rd leading cause of premature death in the United Kingdom. The majority~     of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes,~     injecting drug use) and therefore reversible if caught at a precirrhosis stage. However,~     current liver function blood tests are poor inadequate, and subsequently a large burden of~     liver disease is currently missed.~      A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed~     which identify liver disease accurately at earlier stages of scarring. The identification of~     liver disease in the community, where previous studies have discovered a large burden of~     previously unidentified but significant liver disease, is therefore a feasible place to~     develop new liver disease investigation pathways using these noninvasive markers.~      In collaboration with the Department of Health, Nottingham University Hospitals have~     commenced a pilot community liver disease pathway in two General Practices in Nottingham in~     February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2~     diabetes)are invited to take part in the pathway. Patients undergo a simple blood test~     (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver~     stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan~     values are reviewed by a consultant liver specialist in a community liver clinic.~     Preliminary findings show that the pathway accurately identifies patients with early liver~     scarring and previously unidentified significant liver disease. The participating General~     Practitioners have also noted a striking number of patients finally engaging in important~     lifestyle changes following pathway implementation. A second phase of the pilot pathway, in~     2 Inner City General Practices with a total practice population of c.14,000 patients~     commenced in June 2013.~      We have subsequently designed this cohort study, where pilot participants will be consented~     for follow up over a long period. We will assess future liver-related and cardiovascular~     events (including death), and perform qualitative patient interviews to assess the reasons~     for and persistence of lifestyle changes after liver disease investigation. We hypothesize~     that stratification of liver disease in the community will unearth a significant amount of~     previously undetected but significant chronic liver disease. Moreover, we will evaluate~     whether stratification of liver disease using these tests predicts future liver and~     cardiovascular disease and death, and whether stratification has an impact on patient's~     future lifestyle choices.~   "
77891|NCT02037854|"~     The purpose of this study is to assess whether food ingredient(s) affect glycemic and~     insulinemic responses.~   "
77892|NCT02037841|"~     Asthma is the most common chronic disease of childhood and is responsible for large portion~     of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways~     allow for optimal delivery of care and may result in decreased length of stay, leading to~     important economic benefits. Weaning of asthma medications prescribed for asthma~     exacerbation is not standardized in the current model of care. Currently, weaning is~     performed by ward physicians; in a teaching hospital, this most often done by residents~     staff. Differences in practice between different physicians, delays in patient assessment~     and adjustment of doctor's orders, likely prolong the hospital stay for children admitted~     with asthma.~      This study's main objective is to determine the effect of a nursing-driven clinical pathway~     on children's length of stay when admitted to hospital with a diagnosis of acute asthma~     exacerbation. The pathway will allow nurses to wean a specific type of~     medication(β2-agonist), as compared to the current standard of care, which dictates that a~     physician writes an order to wean the medication. Number of administered β2-agonist~     treatments will be compared between both groups, as well as asthma-related health care~     utilization within two weeks of hospital discharge. Nursing, physician, and patients'~     satisfaction with the pathway will be evaluated, and a cost minimization analysis will be~     performed.~      This study has the potential to improve resource use efficiency, increase patient safety by~     avoiding administration of unnecessary medications, and ameliorate quality of care by~     standardizing the care of children admitted to the hospital with a diagnosis of acute asthma~     exacerbation. The results of the study will be disseminated across the Canadian Health Care~     System with the goal of improving outcomes of children admitted to hospitals with acute~     asthma exacerbations.~   "
77893|NCT02037828|"~     Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of~     chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis.~     Previous studies have found that accelerated loss of forced expiratory volume in 1 second~     (FEV1.0) in an individual is considered an indicator of developing COPD. This functional~     predictive system, due to lower sensitivity, is very difficult to discover high-risk~     population and earlier stage of the disease. The inflammation occurs earlier than the lung~     function impairment. Therefore, early detection of the inflammation may theoretically~     predict the occurrence of COPD and thus may guide early intervention.~      Proteomics techniques and protein chip techniques provides us high throughput screening~     method to figure out characteristic inflammatory or metabolic markers of a diseases. It can~     be used for searching the biomarkers relating to lung function loss. EBC is collected from~     exhaled gas and is a good non-invasive method for exploring the pathologic process of the~     airways.~      Thus we designed this study. This study is divided into two parts: screening target~     biomarkers and identifying biomarkers. The first step is to screen target biomarkers. 20~     COPD patients and 20 controls are to be enrolled in the study and their EBC are to reserved.~     Proteomics techniques and protein chip techniques are to be used to screen COPD specific~     biomarkers. The second step is to the biomarkers screened from the first step and make sure~     which can predict rapid decline of lung function. The study will be a community based,~     multicenter prospective cohort designed, which including a total of 2,400 study subjects.~     EBC are to reserved at the baseline and followed up for two years. Case group is defined as~     subjects with rapid decline of lung function and new COPD patients. Control group is~     selected according to 1:1 matching with age and gender of case group. ELISA are to be~     applied to compare the expressions of biomarkers of the two group at baseline.~   "
77903|NCT02037698|"~     The revascularization of chronic total occlusion of coronary arteries (CTO) is the most~     challenging procedure for the coronary intervention. For the initial period for CTO~     intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated~     with low procedural success rates about 70%. Recently, the success rate of the~     recanalization of CTOs has been raised in several studies.~      Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting~     coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in~     contrast to conventional coronary angiography, reducing the deferral rates from CTO~     intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help~     to determine revascularization strategy and estimate the procedure time, leading to lower~     procedural complications. We suggest that success rates and clinical outcome of intervention~     of CTO lesion can be improved by pre-procedural CCTA.~   "
77894|NCT02037815|"~     Osmotherapy has been used as the medical treatment for brain edema and intracranial~     hypertension in critically brain injured patients. Measurement of serum osmolality during~     osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and~     avoid side effect. Serum osmolality is often measured in laboratory by cryoscopic technique~     as the reference method. However, in clinical setting, routine measurement of serum~     osmolality is not feasible at bedside, either in intensive care unit (ICU) or neurosurgical~     ward. Therefore, clinicians usually estimate serum osmolality by using equations derived~     from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory~     chemical analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol~     or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be~     measured before and during drug infusion. Investigators hypothesize that the correlation of~     measured and calculated serum osmolality is better during infusion of hypertonic saline than~     mannitol.~   "
77895|NCT02037802|"~     pain control in pediatric renal transplant is a major concern. the main goal during~     anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to~     that of the adult donor. epidural analgesia is thought to be very effective in pain control.~     this study emphasises the ease of application of epidural catheter via the caudal route to~     the lower thoracic level; avoiding possible complications that may arise from lumbar or~     thoracic routes, and its effects on hemodynamics when using analgesic doses of local~     anesthetics and narcotics.~   "
77896|NCT02037789|"~     Low back pain (LBP) is one of the most common medical problems encountered in daily life; it~     is related to disability and work absence and accounts for high economical costs in Western~     societies.~      Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with~     different molecular pathologies at different structural levels displaying similar clinical~     manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical~     findings that can be used objectively to help the physician in precise anatomic diagnosis~     leading to the safest and most cost-effective treatment for the patient (reduction of direct~     and indirect costs and improvement of treatment efficacy).~      The main aim of this trial is to identify all omics biomarkers associated with~     susceptibility to chronic/persistent LBP and its different pathophysiology.~   "
77897|NCT02037776|"~     The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to~     placebo in Japanese subjects with Functional Dyspepsia.~   "
77898|NCT02037763|"~     This is a prospective observational cohort multinational clinical study. There are no~     biomarkers to help predict in which patients acute low back pain (LBP) will transform into~     chronic low back pain (CLBP). Human variability and different common comorbidities~     complicate the picture and make stratification of patients into correct subgroups difficult.~     However, drugs act by targeting specific molecular pathways and are therefore efficient only~     in a subgroup of patients sharing common molecular pathology and common genetics. Both CLBP~     and disc degeneration are known to be heritable. Little investigation has taken place for~     genetic variants in CLBP. The main aim of this trial is to identify omics biomarkers~     associated with the transition from acute (single episode of low back pain) to~     persistent/chronic LBP (pain lasting more than 12 weeks).~   "
77899|NCT02037750|"~     The purpose of this study is to conduct a randomized effectiveness trial to determine~     whether adding a preventive intervention at the transition from elementary to middle school~     is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco~     use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and~     school failure for young adolescents in foster care. The proposed LINKS intervention marries~     the goals of child welfare and educational systems. The aims are: a) to determine the~     effectiveness of the LINKS intervention on key behavioral health and school adjustment~     outcomes, b) to examine mechanisms of action; specifically the mediating effects of~     placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes,~     and d) to examine cost effectiveness and cost avoidance of LINKS.~   "
77900|NCT02037737|"~     The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients~     with inadequate response to one or more conventional Disease Modifying Against Rheumatism~     (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention~     rate over 2 years and reasons of discontinuation~   "
77901|NCT02037724|"~     The consequences of iron deficiency anemia in women are enormous, and especially in~     developing countries, as the condition adversely affects both their productive and~     reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators~     among women receiving an iron-rich organic food supplement versus ferrous sulfate~     supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce~     iron deficiency anemia among women in developing country settings.~      A double-blind, randomized, controlled, intervention trial will be implemented in women of~     childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency.~     After screening potential subjects (up to 500 expected), approximately 30 will be recruited~     into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in~     ferritin as significant between the two time points at 80% power and alpha value of 0.05.~     Subjects who meet the inclusion criteria will be randomized into the four groups consisting~     of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate~     (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich~     supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8~     weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for~     12 consecutive weeks.~   "
77902|NCT02037711|"~     Pain after laparoscopic surgery has been associated with surgical manipulations, including~     intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching,~     diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated~     gas in the abdominal cavity after surgery. These effects may result in the irritation of~     peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures~     in pediatrics.~      The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation~     can provide pain relief after laparoscopic surgery, but local anesthetic distribution may~     not always be uniform throughout the peritoneal surface. Many methods were tried for~     intraperitoneal application of local anesthetics in laparoscopic surgery such as local~     anesthetic (LA) instillation and LA nebulization.~      -But these methods are not widely used in pediatrics upon our knowledge~   "
77906|NCT02037659|"~     The purpose of having a database is to collect data related to endoscopic ultrasound~     procedures performed by Indiana University EUS physicians; specifically, for the treatment~     of gastric variceal bleeding This data will be used for research purposes only to determine~     the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The~     physicians will also be able to better understand the patient's condition and disease~     process that may lead to improved standard of care and improved patient management.~   "
77907|NCT02037646|"~     The main aim of this study is to determine whether there is a difference in time to~     diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests~     (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care~     (qualitative FIT and appointment-based referral).~   "
77908|NCT02037633|"~     The purpose of this study is to compare two analgesic methods performed preoperatively to~     assist positioning patients for performance of spinal anesthesia, namely fascia iliaca~     blockade and intravenous fentanyl.~   "
77909|NCT02037620|"~     In this study, we would like to demonstrate that epidural stimulation can be used to recover~     significant levels of autonomic control of the cardiovascular and respiratory function as~     well as the ability to voluntarily control leg movements below the injury level. This~     intervention would provide an immediate therapeutic alternative to individuals who now have~     no recourse for treatment.~      Rationale:~      We propose to determine the functional gain that can be achieved in voluntary control of~     movements below the level of injury and autonomic nervous system function as a result of~     activation of spinal circuits with epidural stimulation (ES) in humans with complete motor~     paralysis. In addition to the scientific advances, the proposed experiments are essential to~     translating this therapeutic approach to a larger scale, which is needed to have a~     meaningful clinical impact. ES for recovery of neurological function in patients with severe~     SCI is not widely used because of uncertainty regarding the mechanisms of action and~     convincing evidence of efficacy in a larger numbers of subjects. Our approach will allow us~     to determine specific types of ES needed for voluntary movement and autonomic nervous system~     dysfunction which lays the groundwork for expedient translation to larger numbers of~     individuals with SCI.~      Current clinical methods of diagnosis of clinically complete SCI may not be sensitive enough~     to detect residual functional synapses across the lesion. We propose to use a series of~     neurophysiological approaches that can detect different sources of supraspinal influence on~     spinal circuitry and identify specific pathways including vestibulospinal, reticulospinal,~     corticospinal and long propriospinal pathways that may remain viable or emerge with ES and~     task specific training after complete motor paralysis. Such residual connectivity would be~     identified by the presence of voluntarily controlled movement or evoked motor potentials~     occurring only in the presence of epidural stimulation. Identifying the essential~     supraspinal-spinal pathways needed to recovery these voluntary movements will advance our~     knowledge of human neural control of movement and provide critical information for~     developing repair and regeneration strategies and in determining the type and severity of~     patient that could benefit most readily in regaining voluntary control using epidural~     stimulation.~   "
77910|NCT02037607|"~     The purpose of this study is to determine how frequently children undergoing elective~     neurosurgical procedures develop blood clots in the deep veins of the legs while~     hospitalized. The information gained from this study will help us determine when children~     children need to receive therapy to help prevent this type of blood clot from forming.~   "
77911|NCT02037594|"~     This study identifies social and behavioral factors likely to influence PrEP acceptability~     and adherence among men who have sex with men (MSM), and collaborates with a community~     health center to evaluate a two-stage intervention to improve PrEP decision-making, as well~     as persistence and adherence for those who chose to take PrEP.~   "
77912|NCT02037581|"~     Improvement of clinical long-term outcome through the implementation of early detection and~     intervention within a specialized network of integrated care (ACT and hometreatment) for~     adolescents and young adults with a first episode of psychosis between 12 and 29 years.~   "
77913|NCT02037568|"~     PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management~     psychoeducation will be expected to obtain a new set of coping skills that will allow them~     to better deal with the stressors of caregiving for an allogeneic HSCT patient. It is~     expected that improving caregiver status will improve patient quality of life.~   "
77914|NCT02037555|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The~     purpose of this study is to determine the safety and effectiveness of human-derived~     antithrombin III (AT-III [Human]) supplementation prior to high-risk, non-emergency, cardiac~     surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who~     meet the study eligibility criteria will be randomized to receive either AT-III (Human) or~     placebo.~   "
77915|NCT02037542|"~     The purpose of this study is to test the hypothesis that an intervention of lifestyle~     modification will positively impact women with breast cancer who are overweight and/or~     obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle~     intervention that can be implemented by overweight or obese women (BMI greater or equal to~     25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI~     over the course of the study.~   "
77916|NCT02037529|"~     This is a two arm Phase III trial in first and second-line HER2 negative patients with~     locally recurrent or metastatic breast cancer. The primary endpoint is overall survival~     (OS), and the objective is to test for the superiority of eribulin mesylate over standard~     weekly paclitaxel. Patients will be randomized between the experimental and control arm with~     equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor~     status, and line of therapy. Subjects will continue protocol directed therapy until~     documentation of disease progression, development of unacceptable toxicity, or withdrawal of~     consent. Those who discontinue study treatment without radiological progression will be~     followed with repeat imaging studies every 12 weeks. All subjects will be followed until~     death, withdrawal of consent, or study termination.~   "
77917|NCT02037516|"~     The purpose of this study is to determine if residual weakness after weight loss surgery~     leads to an increased risk of respiratory complications in the postoperative period.~   "
77918|NCT02037503|"~     Suicide attempts are a serious concern worldwide. Currently, existing drugs take about three~     weeks to show effect on suicidal thoughts and drives. Recent evidence suggests that~     intravenous Ketamine exerts a rapid effect in suicidal patients, even after a single~     injection. We aim to examine whether oral Ketamine is a safe and effective treatment in~     suicidal patients. Following a suicide attempt, patients will be randomized into a group~     that will be given Ketamine for 21 days and one that will receive placebo, and assessed~     using questionnaires and brain scans. We expect early improvements in suicide scales in the~     Ketamine group.~   "
77919|NCT02037490|"~     This is a randomized controlled pilot trial of a peer-based, social media intervention to~     prevent obesity in infants.~   "
78003|NCT02036398|"~     Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL)~     with nephrostomy placement and double J stent and PCNL with double J placement only without~     nephrostomy.~   "
77922|NCT02037451|"~     Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems~     deficit. The clinical symptoms of Parkinson's disease include the following motor tasks:~     difficult in initiating movement, performing rhythmic movement or serial movement, the~     ability of learning motor movement is also affected. The primary treatment for Parkinson's~     disease is medical treatment; surgery is used if in need. Rehabilitation such as physical~     therapy, which aims to improve patient's quality of life and functions, is a non-invasive~     treatment and value for PD patients. Auditory cue is a technique that widely applied on~     training patients with Parkinson's disease, and some researches revealed that auditory~     cueing could improve motor performance. However, the mechanism under this treatment~     technique is still unknown.~      This study is to investigate the effect of auditory cueing on rhythmic finger movement in~     patients with Parkinson's disease. To investigate the mechanism under auditory cueing,~     neurophysiological data such as motor cortex excitability and blood flow in cortical cortex~     will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared~     spectroscopy (NIRS).~   "
77923|NCT02037438|"~     Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART~     DOCS) will develop and evaluate a new approach (patient-centered outcomes and~     coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders.~     Specialized and pertinent information and resources regarding sleep disorder management will~     be developed and made available through an online portal, allowing patients to make informed~     health care decisions, and providers to assist patients in achieving what they feel are the~     most important goals regarding their care. Half of participants will be randomized into the~     conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered~     outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective~     assessment measures will be administered at intervals throughout a 13 month participation~     period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep~     medicine results in increased patient satisfaction, quality of care, and improved health~     outcomes. Qualifying participant will be 18 years of age or older, presenting with a new~     sleep disorder. Patients will be enrolled for 13 months and will receive no monetary~     compensation.~   "
77924|NCT02037425|"~     To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA~     by collecting and correlating pre and post treatment subject specific history, clinical~     outcomes, and histological changes.~   "
77925|NCT02037412|"~     The investigators hypothesized that ticagrelor may enhance endothelial healing after DES~     implantation by increasing adenosine concentrations by the inhibition of adenosine uptake~     into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent~     of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal~     thickness) 3 months after DES implantation by optical coherence tomography (OCT)~   "
77926|NCT02037399|"~     Besides major ESD-related complications, minor adverse events after ESD are also commonly~     noticed. Pain is one of minor ESD-related complications. . The causes of pain associated~     with ESD or gastric polypectomy are thought to be associated with transmural burn or~     transmural air leak. How control localized pain for patients who suffered from pain after~     ESD is appearing as new medical interests. There are few studies about management strategy~     for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in~     various clinical settings including inflammatory disease, rheumatic disease, and so on. The~     efficacy of glucocorticoids for reducing pain after surgery has recently been investigated.~     Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally~     reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous~     effect through stable serum concentrations. If pain was partially associated with acute~     inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after~     ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative~     intravenous dexamethasone for pain relief after ESD.~   "
77927|NCT02037386|"~     Intervention for coronary bifurcation lesion is about 10~20% of entire percutaneous coronary~     intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at~     bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore,~     occlusion of side branch frequently occurred during PCI. Several techniques to prevent~     occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side~     branch stent is developed to treat coronary side branch lesion and composed of proximal,~     connecting and distal parts. In vivo study performed in pigs showed effective H-side branch~     stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of~     coronary side branch lesion.~   "
77928|NCT02037373|"~     Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in~     patients undergoing orthotopic liver transplantation (OLT). The primary objective is to~     assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™~     versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma~     products).~   "
77929|NCT02037360|"~     The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training~     smartphone application on smoking cessation in smokers ages 18 to 65 years.~   "
77930|NCT02037347|"~     To test the ability of palifermin (a recombinant human keratinocyte growth factor) to~     decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis~     and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is~     extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal~     tract, respiratory and genitourinary systems.~   "
77931|NCT02037334|"~     Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy~     will be compared between women with term vs. preterm delivery. We aim to demonstrate that~     biomechanical data (ASP and CCI) might complement morphological data (CL) to improve~     prediction of preterm delivery. It is expected that women with preterm delivery will show~     stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical~     consistency index) measurements are performed at mid-pregnancy: detection at this time point~     is useful for therapy and biomechanical modifications are already significant so to enable~     differentiation by biomechanical measurements (ASP and CCI).~   "
80611|NCT02002286|"~     This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T~     cell immune activation and immune activation in HIV-infected immunological non-responders.~     The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV~     immunological non-responders.~   "
77932|NCT02037321|"~     Vegetarian diets have been associated with a reduced risk of preventable diseases such as~     type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or~     indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains,~     and unsaturated plant oils have each individually been associated with lower risk of type 2~     diabetes and cardiovascular disease, so too has the displacement of red meats, processed~     meats, and saturated animal fats. One of the most important considerations in moving from~     animal-based diets to more plant-based diets is the replacement of animal proteins (e.g.~     meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is~     unclear whether this particular replacement alone results in advantages for metabolic and~     cardiovascular health. To improve evidence-based guidance for dietary guidelines and health~     claims development, we propose to conduct a series of systematic reviews and meta-analyses~     of the effect of plant-based protein in exchange for animal protein on blood lipids,~     glycemic control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty~     liver disease (NAFLD), and kidney function and injury. The systematic review process allows~     the combining of the results from many small studies in order to arrive at a pooled~     estimate, similar to a weighted average, of the true effect. The investigators will be able~     to explore whether the effects of replacing animal-based protein for plant-based protein~     hold true across different sexes, age groups, and background disease states and whether the~     effect depends on the protein source, dose, or background diet. The findings of this~     proposed knowledge synthesis will help improve the health of Canadians through informing~     recommendations for the general public, as well as those at risk of heart disease and~     diabetes.~   "
77933|NCT02037308|"~     The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events,~     proposed to be due to reduced nitric oxide production by eNOS reported in some but not all~     studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp~     polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite,~     particularly in carriers of the T allele, which have been associated with lower eNOS~     activity and increased risk of hypertension.~   "
77934|NCT02037295|"~     The prevalence of obesity has risen to epidemic proportions in the world, resulting from~     both excessive energy intake and low levels of energy expenditure. The effect of nutrient~     absorption on energy balance, that is, the relative amount of nutrients consumed vs. the~     amount excreted in stool, has been reported only in small studies in which energy waste in~     feces and urine between lean and obese individuals was not found to be different. New~     studies have shown that bacteria in the gut may play an important role in calorie~     absorption. We have recently shown that leaner individuals absorbed more calories when~     overfed compared to when they were given a diet with just enough calories to maintain their~     own weight. Our studies have also found that overfeeding also changes the kinds of bacteria~     found in the gut. In lean individuals, these changes in gut bacterial communities with~     overfeeding were associated with changes in how many calories were absorbed. Our results are~     similar to those seen in other studies in animals and humans that suggest a role for gut~     bacteria in weight gain and obesity. To try to better understand the role of gut bacteria in~     absorbing food, we propose to investigate 1) whether energy loss (as measured in stool and~     urine) changes following over- and underfeeding relative to body size and 2) whether changes~     in the gut bacteria, induced by an antibiotic medication, affect nutrient absorption and~     glucose tolerance. We plan to study 24 healthy non-smoking volunteers age 18 45 years old,~     not taking any medications (including medications for weight loss, antibiotics or~     probiotics) for the examination. All participants will be admitted to the Clinical Research~     Unit for 31 days. During their stay, subjects will be fed a weight maintaining diet for 3~     days, followed by two experimental diets (150% and 50% of weight maintaining calories) in a~     random order. After this, volunteers will be randomly assigned to one of two groups: group 1~     will take oral antibiotic medication; group 2 will receive pills that look the same but will~     not contain any active medication (placebos). Feces (stool) will be collected throughout the~     study. Additionally, twenty four-hour urine collections will take place each day of the~     experimental diet period and when stool is collected on the antibiotics. The energy content~     of these waste products as well as that of the diet (using duplicate plate analysis) will be~     measured by bomb calorimetry. Bacterial components in feces will be extracted by repeated~     fractional centrifugation to obtain bacterial mass and by using 16S rDNA-based~     oligonucleotide probes to obtain data on gut bacteria. Primary results will examine how many~     calories remain in stool during relative over- and underfeeding and whether changes in gut~     bacteria, induced by an antibiotic medication, affect nutrient absorption and glucose~     tolerance....~   "
77935|NCT02037282|"~     Despite currently available antivirals, influenza causes significant morbidity and~     mortality, with 226,000 excess hospitalizations and 30,000-50,000 deaths each year in the~     United States alone, and more therapies are needed in the armamentarium of anti-influenza~     medications including humoral immunity-based agents.~      This study will evaluate the pharmacokinetics of an anti-influenza hyperimmune intravenous~     immunoglobulin. Beginning with a low dose, subjects will receive anti-influenza intravenous~     immunoglobulin (FLU-IVIG) and evaluated on Study Days 0, 3, 7, 14, and 28. The safety and~     tolerability is evaluated using symptoms, clinical laboratory tests, and pharmacokinetics.~     Utilizing serum antibody responses as determined by hemagglutination inhibition (HAI)~     assays, the dose will be escalated as immunogenicity is established.~   "
77936|NCT02037269|"~     This study is a prospective, cross-sectional observational single centre study to assess the~     feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide~     local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using~     the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a~     light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera.~     This study will measure the correlation between margin status of the WLE specimen and the~     metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System~     and by histopathology. This is a pilot study to assess feasibility before proceeding to a~     pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical~     practice.~   "
77937|NCT02037256|"~     This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the~     combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin~     lymphoma patients. Giving chemotherapy before a peripheral stem cell transplant stops the~     growth of cancer cells by stopping them from dividing or killing them. After treatment, stem~     cells are collected from the patient's blood and stored. The stem cells are then returned to~     the patient to replace the blood-forming cells that were destroyed by the chemotherapy.~   "
77938|NCT02037243|"~     An estimated 2.2 million children under the age of 5 years die from diarrheal disease each~     year. Most of the burden of diarrheal disease is thought to be preventable with improvements~     in sanitation, water quality, and hygiene. Large scale interventions promoting these~     behaviours have either not been rigorously tested or have not produced sufficient change to~     warrant being rolled out at scale.~      Research into the determinants of hand washing behaviour has identified disgust and shame as~     key motivators. Evidence supports the theory that disgust is a natural behavioural reaction~     to objects carrying disease risk, thus it may act as a key motivator for other health~     related behaviours such as water treatment. Whether this knowledge can be harnessed to~     increase the efficacy of hand washing and safe water campaigns in Bangladesh or elsewhere~     has yet to be rigorously tested.~      The investigators will develop an intervention that utilizes disgust and shame eliciting~     messages to promote hand washing with soap and point of use water treatment in low income~     housing compounds of urban Dhaka. The investigators will test the efficacy of this~     intervention against a more traditional public health intervention based on increasing~     knowledge of health risks and germ transmission using a randomized controlled trial. The~     study sample will be broken into the following four arms.~        1. Standard Public Health Intervention with Water Treatment~        2. Standard Public Health Intervention with Water Treatment & Hand Washing~        3. Disgust and Shame Based Intervention with Water Treatment~        4. Disgust and Shame Based Intervention with Water Treatment & Hand~      This design will allow us to compare outcomes for hand washing and water treatment between~     both standard public health interventions and disgust and shame based interventions as well~     as test the overall efficacy of the program comparing with the control. Data will be~     collected from all compounds at baseline, three month midline and at the six month endline~     giving us the practical and analytical benefits of a longitudinal dataset.~      Compounds will participate in interactive, educational safe water and/or hygiene promotion~     meetings. For the Disgust and Shame group, these meetings will emphasize disgust and shame~     related to unsafe water and/or hygiene practices, whereas the Standard group's meetings will~     resemble a more typical public health intervention explaining the risks and methods of~     contamination.~      At the first meeting, compounds will receive a one month free trial of the latest compound~     based chlorine dispenser model to treat their drinking water. A randomly selected half will~     also receive a one month free trial of the latest compound based handwashing station. At the~     end of the month, there will be a sales meeting in which the investigators will measure~     compound members' willingness to pay for the trialled products by giving them the~     opportunity purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction.~      In assessing the impact of the interventions, the investigators are primarily interested in~     whether the prevalences of safe water and hygiene behaviours differ by treatment arm and~     over time. The best measurements for approximating behaviour prevalence are physical~     observations (presence of residual chlorine, hand cleanliness inspections), structured~     observation of behaviour, rapid physical observations (physical state of hardware/drinking~     water), self-report of water treatment and hand washing behaviour and willingness to pay for~     necessary products. The investigators will also attempt to measure and track changes in~     personal determinants of behaviour such as feelings of disgust and shame related to hand~     washing and water treatment behaviours.~   "
77939|NCT02037230|"~     The investigators' long-term goal is to improve the survival of patients with pancreatic~     cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor~     MK-1775.~   "
77960|NCT02036957|"~     Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar~     erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation ,~     rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers ,~     photosensitivity reactions, swelling of the face and purple) . The impact in patients'~     quality of life is great, so We had decided to conduct a randomized clinical trial to~     evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient~     treated with capecitabine .~      Design: Randomized clinical trial phase II, in parallel and double-blind groups~      Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will~     initiate treatment with capecitabine monotherapy.~      Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary~     diagnosis, capecitabine monotherapy, sign the informed consent.~      Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary~     endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be~     analyzed by a logistics regression model~   "
77940|NCT02037217|"~     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial~     MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory~     movement disorders, namely Essential Tremor (ET).~      This study is designed as a prospective, single site, single arm, nonrandomized study.~     Assessments will be made before and three months after MRgFUS for clinical symptom relief,~     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of ET. Similarly,~     QoL measures will be obtained using Quality of Life in Essential Tremor (QUEST)~     questionnaire. Relative Safety will be evaluated using a common description of Significant~     Clinical Complications for patients treated in this study. This study will be performed on~     the 3T MR scanners.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion~     created in the ventralis intermedius nucleus of the thalamus.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in~     progress, and confirm that the ablation is proceeding according to plan, thus closing the~     therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      The ExAblate transcranial system is an experimental device and is being investigated in this~     study.~   "
77941|NCT02037204|"~     Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead~     to functional disability and osteoarthritis. Cartilage cell therapy using autologous~     chondrocyte implantation (ACI) has been established as the first advanced treatment therapy~     medicinal product. Although this technique has achieved good mid-term results, it is a~     costly and extensive two-stage procedure which is limited by the number of chondrocytes~     obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore,~     there is a need for improvement. A new cartilage repair technique should aim at decreasing~     surgical trauma, lowering complexity, improving logistics and cost-effectiveness while~     retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells~     (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the~     chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving~     the pericellular matrix of chondrocytes improves cartilage formation. These chondrons~     (chondrocytes with their pericellular matrix) have shown improved cartilage formation when~     combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with~     fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This~     will reduce patient morbidity and improve patient care through immediate transplantation of~     a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to~     evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage~     lesions of the knee.~   "
77942|NCT02037191|"~     Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult~     with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and~     efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in~     the treatment of severe types of AA.~   "
77943|NCT02037178|"~     The main objective of this study is to evaluate the inter-observer concordance when~     measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta~     (both cross-sectional and longitudinal ultrasound views are measured). The first measure is~     made by a general practitioner in private practice; second reading are made by an expert in~     vascular medicine.~   "
77944|NCT02037165|"~     -  To investigate the influence of different doses of BI 1026706 on the primary endpoint~          (PtP-amplitude LEP in UV skin) compared to placebo.~        -  The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.~        -  Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin~          treatment~        -  Exploration of the pharmacokinetics of BI 1026706~        -  Exploration of safety and tolerability of BI 1026706~   "
77945|NCT02037152|"~     The purpose of this study is to test a smartphone-based mindfulness training program for~     chronic pain. Research participants use a 20 minute app-guided audio program six days per~     week. The study hypothesis is that training in this technique over a period of four weeks~     will reduce pain interference with daily life activities. This study does not require any~     travel or in-person contact with research staff-- all elements of the study are completed on~     the participant's smartphone.~   "
77946|NCT02037139|"~     Hearing loss screening rates in for older persons in primary care clinics are very low even~     though hearing loss is relatively common for older persons. When diagnosed with hearing loss~     older persons are often reluctant to follow through. This study involves a prospective~     controlled trial comparing the effectiveness of three primary care based protocols for older~     adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to~     and use of hearing health care services. The protocols will compare: 1) screening only~     (standard care control); 2) screening plus an illustrated educational brochure; and 3)~     screening plus an in-person educational intervention and an illustrated educational~     brochure. Screening will be done by primary care personnel. Participants will be tracked for~     8 months to assess outcomes.~   "
77947|NCT02037126|"~     The primary purpose of this study is to evaluate the feasibility and estimate the efficacy~     of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of~     psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine~     involvement (e.g., criminal involvement).~      MRI assessment is a unique aspect of this study. As a potential biological mechanism of~     psilocybin's effect includes changes in default mode network functional connectivity~     (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are~     mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate)~     abnormalities have been shown to play a role in cocaine addiction, we will determine if~     psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.~   "
77961|NCT02036944|"~     The purpose of this study is to determine if patients with unexplained iron deficiency have~     underlying diseases processes such as celiac disease.~      It is hypothesized that selectively screening patients with unexplained iron deficiency will~     reveal previously undiagnosed etiologies, including celiac disease and other causes of iron~     malabsorption along with various sources of occult GI blood loss.~   "
77962|NCT02036931|"~     The primary purpose of this study is to evaluate the clinical and radiographic performance~     of the G7 Acetabular Cup System.~   "
77948|NCT02037113|"~     This is a prospective, single-center study. The patients with peripheral arterial disease~     who underwent abdominal aortograms with runoff (which are arteriograms of the lower~     abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent~     deployment will be enrolled in the study. All patients who participated in the study will be~     treated according to standard of care.~      HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on~     peripheral artery intervention.~      SPECIFIC AIMS~        1. To determine intravascular ultrasound parameters of stent deployment and outcomes of~          Femoro-popliteal Disease~        2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease~        3. To obtain data that will eventually support development of a predictive model for ISR~          in Femoro-popliteal Disease~      METHODOLOGY Visit 1: After consent is given~      The subject will receive standard follow-up care. A member of the research team will collect~     information such as the subject's age, sex, ethnicity, and medical information from the~     subject's medical record.~      Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+-~     2 weeks)~      The subject will complete standard follow-up appointment at TTUHSC. This may include a~     Doppler ultrasound.~      A member of the research team will record information such as medications, ultrasounds, and~     need for additional care related to the subject's stent.~      The subject will complete the questionnaire on leg pain and mobility.~   "
77949|NCT02037100|"~     SDB has been identified as an important risk factor for insulin resistance and the metabolic~     syndrome.~      In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to~     improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).~      In children, there are only 3 studies that have examined the relations between SDB, obesity~     and the metabolic syndrome.~      In order to further understand the relative contribution of SDB to the development of~     impaired glucose homeostasis and metabolic abnormalities we aim to investigate the~     prevalence and severity of SDB in children with T2DM compared to obese children without~     T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among~     obese children with T2DM compared with the general obese pediatric population.~   "
77950|NCT02037087|"~     It is hypothesized that delivering short messages (SMS) to pregnant women can improve~     maternal and newborn health outcomes. This pilot offers mothers-to-be in rural China free~     daily short messages (SMS) via cell phone. The aim is to advise them on (a) good household~     prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life~     for mothers and newborns.~   "
77951|NCT02037074|"~     This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral~     dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308~     administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic~     regimen.~   "
77952|NCT02037061|"~     This is a randomized controlled trial to determine if intraoperative local analgesia~     administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by~     patients postoperatively after SSL colpopexy.~      Hypothesis: Local analgesia administered at the level of the sacrospinous ligament can~     lessen the gluteal pain felt by patients postoperatively after SSL colpopexy.~   "
77953|NCT02037048|"~     This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil~     followed by surgery and response based concurrent chemotherapy and radiation therapy works~     in treating patients with cancer of the esophagus, gastroesophageal junction, or gastric~     cardia. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,~     paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Radiation therapy uses high~     energy x rays to kill tumor cells. Giving chemotherapy followed by surgery and response~     based chemotherapy and radiation therapy may kill more tumor cells.~   "
77954|NCT02037035|"~     This study is looking at the mechanisms underlying the behavioral effects of ketamine in~     healthy and depressed individuals.~   "
77955|NCT02037022|"~     This is a research study examining the effectiveness of a pivotal response treatment package~     (PRT-P) in targeting language skills in young children with autism.~   "
77956|NCT02037009|"~     In France, cataract surgery is the most frequent surgical procedure, performed with local~     anesthesia and most often very light techniques using eye-drops. Technical improvements of~     surgical and anesthesic procedures have led many countries to implement alternative~     surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic~     surveillance (doctors or nurses) should be qualified in anesthesia.~      In this study, the investigators aim to assess the feasibility and safety of a centralised~     monitoring station outside of the operating rooms, as an alternative to the presence of 1~     anesthetic nurse in each operating room.~   "
77957|NCT02036996|"~     The objective of this study is to collect heart rate, respiration data and motion data of~     patients admitted to sleep lab and to determine the current accuracy level of the EarlySense~     system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep~     lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts,~     oximeter) that are currently used in the sleep lab among different population (Obese,~     patients with or without apnea, patients with or without arrhythmia). It is emphasized that~     no interpretations or clinical decisions will be made based on data received from the ES~     study device.~   "
77958|NCT02036983|"~     Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with~     dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under~     direct visualization will be compared it to a standard anesthetic technique (control)~     following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are~     hypothesizing that the bilateral TAP block and preperitoneal instillation of local~     anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction~     and post-operative pain control when compared to a standard anesthetic technique (no~     regional technique).~   "
77959|NCT02036970|"~     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in~     patients with pulmonary hypertension to determine the recommended dose range, evaluate the~     change from baseline in 6-minute walk distance (6MWD) and determine the effect of~     Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease,~     interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO~     Group III or WHO Group V PH following 16 weeks of study participation.~   "
77966|NCT02036879|"~     The objective of this study is to investigate the impact of hormones on lung disease in~     Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and~     healthier lives than they did 20 years ago. However, females have been shown to have a~     survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The~     hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.~     Therefore, understanding the impact of sex hormones (including the use of birth control~     pills) on the disease process is increasingly important. The purpose of this study is to~     determine if lung function, respiratory symptoms, or various markers of lung health change~     during different phases of the natural ovulatory cycle in order to understand if estrogen or~     progesterone hormones are impacting the disease relative to fluctuations in men with stable~     testosterone levels. The research objectives of this project are to:~        -  Determine if lung function, respiratory symptoms, or various markers of lung health~          change during different hormonal phases of the ovulatory cycle in women.~        -  Determine if men change lung function, respiratory symptoms, or various markers of lung~          health over time.~        -  Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and~          improve lung health.~   "
77967|NCT02036866|"~     To determine differences in thigh muscle function in individuals with and without knee~     arthritis, and also determine the effectiveness of common physical therapy interventions on~     clinical and patient oriented outcomes.~   "
77968|NCT02036853|"~     This study is being done to assess the safety and long-term efficacy of triheptanoin in~     patients with Glut1 DS over a 4-year treatment period. Glut 1 is a protein that helps~     transport glucose to the brain. Glucose is the brain's primary source of energy. Glut 1 DS~     prevents this protein from being effectively produced causing starvation of the brain.~      This study is being done to assess the safety and long-term efficacy of triheptanoin in~     pediatric patients with Glut1 DS over a 4-year treatment period. Glut 1 is a protein that~     helps transport glucose to the brain. Glucose is the brain's primary source of energy. Glut~     1 DS prevents this protein from being effectively produced, causing deprivation of energy to~     the neurons of the of the brain.~      Glut1 DS is a severely debilitating disease characterized by seizures, developmental delay~     and movement disorder. There are currently no approved treatments specific to Glut1 DS.~     Treatment generally includes medications for control of seizures. The use of a ketogenic~     diet can be effective in controlling seizures when medications are ineffective or provide~     insufficient control. However, the ketogenic diet may be very difficult for patients to~     maintain for long periods of time, and there may be negative secondary long-term effects of~     ketogenic diet.. Triheptanoin is metabolized to molecules that can provide an alternative~     energy source to the brain, and appears to help in controlling seizures without many of the~     difficulties of the ketogenic diet.~      Eligible patients may be those who have been diagnosed with GLUT1 DS, and have discontinued~     or are not currently on ketogenic diet, or are able to tolerate triheptanoin if they have~     been treated or are currently being treated with triheptanoin and do not qualify for any~     other clinical trial.~   "
77969|NCT02036840|"~     The proposed research project will retrospectively review the anesthetic records over the~     past 5 years and identify patients who present with a history of penicillin allergy or~     allergy to an antibiotic in the penicillin family. The reason for that history and the facts~     on which that allergy are noted will be determined. Additionally, the choice of antibiotic~     prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also~     note whether appropriate timing of the antibiotic is achieved.~   "
77970|NCT02036827|"~     The purpose of this study was to investigate whether there is any difference in incidence of~     shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate~     neuromuscular block and deep neuromuscular block.~   "
77971|NCT02036814|"~     The aim was to test if interpersonal relationships group strategies provided by nursing can~     promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in~     hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A~     10 patients (8 women), underwent to a health educational orientation program~     (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings).~     Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days~     during 4 months (3 meetings). Both groups received the same content guidelines (healthy~     lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline~     (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL~     questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30~     days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120~     days.~   "
77972|NCT02036801|"~     Aim of this study is to assess lung specific elastance in a population of pediatric patients~     with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in~     a pediatric population of ICU patients with healthy lung which are treated with mechanical~     ventilation for other clinical purposes.~   "
77973|NCT02036788|"~     Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is~     fundamental to assess mechanical characteristics of the respiratory system during mechanical~     ventilation. The correct positioning of the catheter (usually at the medium third of the~     esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the~     correct positioning of the catheter is verified with an occlusion test (If the patient is~     breathing spontaneously) or with thoraco-abdominal compressions (if the patient is sedated~     and paralyzed). Aim of this study is to compare the accuracy of these two methods at~     different PEEP and esophageal catheter positions.~   "
77974|NCT02036775|"~     To characterise pharmacokinetics and assess the relative bioavailability of two new oral~     formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg~     and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg~   "
77975|NCT02036762|"~     THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE~     PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND~     SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE~   "
78004|NCT02035332|"~     The primary objective of this study is to evaluate the use of the Aurora Ablation System in~     reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events~     will be assessed along with an assessment of the reduction of uterine bleeding as measured~     by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.~   "
77976|NCT02036749|"~     The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael~     Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting~     local anesthetics close to the anterior border of the quadratus lumborum muscle. In our~     randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female~     patients after cesarean delivery will be compared with a placebo control group of 20~     patients to investigate analgesic consumption, pain level, opioid related side effects and~     mobilization.~   "
77977|NCT02036736|"~     The recovery of cognitive and psychomotor functions is best performed under anesthesia after~     desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing~     SSPI.~      The principal objective is to compare the cognitive and psychomotor status of patients~     recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)~     using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory~     (visual verbal learning test) made SSPI.~   "
77978|NCT02036723|"~     GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021~     (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related~     macular degeneration. The purpose of the study is to demonstrate the non-inferiority of~     efficacy and safety of BCD-021 compared to Lucentis®.~   "
77979|NCT02036710|"~     Background: Physicians do not have a unified, scientifically tested theory of causation for~     obesity and its comorbidities, nor do they have explanations for the mechanics of the~     metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of~     the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.~      Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the~     terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese~     patients undergoing a duodenal switch procedure.~      Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120~     minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.~   "
77980|NCT02036697|"~     We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central~     venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section:~     a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence~     of hypotension, and compare pain control and maternal satisfaction during and after cesarean~     section.~      We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent~     anesthesia for cesarean section compared to conventional dose bupivacaine, with less~     hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction~     will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering,~     and ability to interact with baby in the OR.~   "
77981|NCT02036684|"~     Radical prostatectomy is the most common and effective treatment for localized prostate~     cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects,~     such as urinary incontinence, sexual dysfunction, and reduced physical function that~     collectively diminish health-related quality of life which may persist for up to two years~     postoperatively. The primary objective of this trial is to assess the feasibility of~     conducting of a multi-site randomized controlled trial to test the effect of a comprehensive~     prehabilitation program versus standard care for men with prostate cancer undergoing radical~     prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy~     in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle~     exercises) will report better health-related quality of life, urological symptoms, and~     physical fitness, physical activity, and pain, as well as a shorter postoperative length of~     stay than participants receiving standard preoperative care (pelvic floor muscle exercises~     alone). Our secondary objective is to report estimates of efficacy on several clinically~     important outcomes for this population that will be used for sample size calculations in an~     adequately powered trial.~   "
77982|NCT02036671|"~     The objective of this study is to evaluate the safety and efficacy of the FLEX System when~     used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with~     Chronic Kidney Disease (CKD) who require hemodialysis vascular access.~   "
77983|NCT02036658|"~     The purpose of the study is to investigate the immediate and longer-term impact of~     Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR)~     for patients with Social Anxiety Disorder.~   "
77984|NCT02036645|"~     The purpose of this study is to assess the safety, drug levels and effects on the body of 1~     or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy~     elderly people.~   "
77985|NCT02036632|"~     First, this study will investigate the viability of 24-hour eye patching as a potential~     treatment modality for CSR. Second, this study will assess a potential physiologic~     explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will~     aid in ameliorating disease severity and disease duration.~   "
77986|NCT02036619|"~     The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM)~     will lead to an important increase in the work load and the prevalence of GDM in Belgium but~     that this might not be cost effective concerning the prevention of adverse pregnancy~     outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for~     women diagnosed with the two-step screening strategy.~      In this prospective multicentric cohort study, women will be universally screened for~     pregestational diabetes and GDM at the first prenatal visit during the first trimester by~     measuring the fasting plasma glucose. In the second trimester, women without diagnosis of~     diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g~     glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG~     criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.~   "
77999|NCT02036450|"~     The LOOP study aims to clarify whether stroke and peripheral emboli can be prevented by~     monitoring the heart rhythm with a small device (called a loop recorder). The recorder which~     is placed under the skin on the front of the chest wall allows monitoring of the heart~     rhythm 24-hours a day 7 days a week.~      The study has 6,000 participants with risk factors for stroke (age >70 years, and at least~     one of the diseases: diabetes, hypertension, heart failure or previous stroke) but without a~     history of atrial fibrillation, of which 1,500 will have a loop recorder implanted and 4,500~     will be included in a control group. Participants are randomised to receive a loop recorder~     or not (control).~      If a participant has atrial fibrillation of more than 6 min duration the study participant~     will start oral anticoagulation therapy according to local guidelines.~   "
77987|NCT02036606|"~     Racing thoughts relate to subjective acceleration of thinking which has been essentially~     associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of~     racing thoughts in major depression seems to differ from rumination and pure manic racing~     thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative~     evidence is consistent with the existence of these two kinds of thought overactivity~     related to mood disorders. In order to evaluate this and better understand the~     psychopathological and cognitive mechanisms that underlie thought overactivity in mood~     disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts~     Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive~     flexibility). Also, given the relationship between mood disorders and creativity, it is~     likely that thought overactivity is related to increased creativity. We aim at evaluating~     this relationship through the French version of the Cognitive Processes Associated with~     Creativity scale (CPAC).~   "
77988|NCT02036593|"~     The Specific Aims for CATCH: PATH are:~      Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a~     multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase~     opportunities for active living, specifically walking groups, in three communities in~     Detroit.~      Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a~     multilevel CBPR intervention (i.e., organization, community, policy levels) to promote~     leadership development, community action, and policy level change to enhance neighborhood~     environments that support and sustain active living.~      Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the~     partnership in providing scientific and community oversight for all aspects of the CATCH:~     PATH project.~      Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination~     Plan to share research findings through community and peer reviewed outlets to assure~     translation of results from this multilevel CBPR intervention into programmatic and policy~     efforts to improve heart health in eastside, northwest and southwest Detroit.~   "
77989|NCT02036580|"~     The purpose of the study is to evaluate the safety and tolerability of multiple-doses of~     tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.~   "
77990|NCT02036567|"~     This longitudinal observational study will attempt to objectively measure pain with an~     experimental, non-invasive device. Patients and volunteers will receive a baseline screening~     with psychophysical tests and questionnaires. Investigators will apply the device to measure~     pain during routine clinical care and correlate patients pain ratings and analgesia~     requirements to that measured by the device. A more standardized approach with experimental~     pain stimuli will be pursued in human volunteer studies.~   "
77991|NCT02036554|"~     To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus~     in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset~     Diabetes Mellitus after transplantation in the renal allograft recipients~   "
77992|NCT02036541|"~     To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with~     refractory glaucoma.~   "
77993|NCT02036528|"~     The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus~     oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to~     moderately infected foot ulcers in diabetic patients.~   "
77994|NCT02036515|"~     This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment~     of participants with type 2 diabetes mellitus who have inadequate glycemic control on~     metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin~     A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of~     placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides~     greater reduction in A1C compared with the addition of placebo; the primary objective will~     be tested for both 5-mg and 15-mg doses of ertugliflozin.~   "
77995|NCT02036502|"~     This is a study of pembrolizumab (MK-3475) in combination with lenalidomide and low-dose~     dexamethasone in participants with refractory or relapsed and refractory Multiple Myeloma~     (rrMM), and in combination with carfilzomib and low-dose dexamethasone in participants with~     relapsed or refractory Multiple Myeloma (rMM).~      This study is being done to find the maximum tolerated dose (MTD)/maximum administered dose~     (MAD) and recommended Phase 2 dose (RP2D), and to evaluate the safety and tolerability of~     pembrolizumab when given in combination with standard of care (SOC) treatments in~     participants with rrMM or rMM. Preliminary efficacy data will also be assessed. The primary~     study hypothesis is that these combinations are sufficiently well tolerated to permit~     further clinical investigation.~   "
77996|NCT02036489|"~     Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL~     treated with a pediatric protocol.~   "
77997|NCT02036476|"~     This is an open-label, non-randomized, phase 2 study to assess the feasibility of using~     cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after~     platinum-based therapy.~   "
77998|NCT02036463|"~     Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disease for which no~     curative treatment has yet been identified, making it important to slow progression and~     improve the quality of life among affected boys and young men. Treatment with~     corticosteroids is standard of care for patients with DMD five years old and older, due to~     the robust observation that this intervention lengthens the interval prior to loss of~     ambulation but is associated with many side effects. This clinical trial will be conducted~     in the youngest age group able to receive corticosteroids orally and on whom study outcomes~     are measurable, ages 3 to 7 years. This is a randomized, double blinded, double masked,~     placebo-controlled clinical trial that will explore whether better synchronization of~     corticosteroid administration with the circadian rhythm will provide improved tolerability~     and at least comparable efficacy to current standards in which corticosteroids are always~     given in the morning. Furthermore, the trial provides a unique opportunity to rigorously~     evaluate corticosteroid effects in the young DMD patient, both for efficacy as compared to~     placebo and as a study of the impact of corticosteroid chronotherapy, or delayed release, on~     increased tolerability over standard therapy. The main hypothesis is that synchronization of~     the timing of corticosteroid dosing will improve medication tolerability in children, while~     maintaining (non-inferiority) the efficacy of corticosteroid. The study also offers a unique~     opportunity to measure several biomarkers as well as novel genetic modifiers that may~     further impact the response to corticosteroid in DMD.~   "
78005|NCT02035319|"~     In this research study investigators want to learn more about capillary malformations which~     are also known as port wine stains.~      Investigators are asking children with capillary malformations (port wine stains) to be in~     the research, because investigators do not have a good idea of what to expect from the~     current treatments of these malformations. These malformations are treated with laser as~     clinically indicated and there are no standardized methods to assess improvement.~   "
78006|NCT02035306|"~     To answer the question whether a non-invasive haemaglobin measurement is clinically useful,~     reliable and accurate as compared to taking a blood sample and checking the haemaglobin~     level at the laboratory or in a blood gas analyser. This study will take place in a~     multi-disciplinary ICU of critically ill patients.~   "
78007|NCT02036372|"~     The incidence of diabetes mellitus type II is increasing. More and more patients who need~     surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering~     protocols and the proven negative effects of hyperglycaemia. There is no evidence for the~     optimal glucose lowering protocol.~      This study investigates the optimal intraoperative treatment algorithm to lower glucose in~     patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing~     intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and~     GLP-1 (liraglutide, LG) treatment.~   "
78008|NCT02036359|"~     To compare clinical response (complete response and partial response) by RECIST) rates by~     RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy~   "
78009|NCT02036346|"~     One of the main reasons for hospital readmission in ileostomy patients is fluid and~     electrolyte abnormalities. Prospective observational studies have suggested an occurrence~     rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium~     and fluid through their stoma effluent. In addition studies have shown that ileostomy~     construction is a risk factor for renal impairment, occurring secondary to dehydration.~      Encouraging patients to increase total fluid intake seems to be a common mistake in clinical~     practice as this can dilute sodium levels even more, causing greater sodium depletion. In~     terms of addressing the problem a few small studies have used isotonic drinks of various~     compositions showing increased electrolyte absorption.~      Other dietary complications sometimes include hypomagnesaemia and decreased absorption of~     B-12 and folic acid, however due to the integrity of the small intestine other nutrient~     malabsorption is unlikely to occur. As far as body composition is concerned obesity has been~     shown to be a risk factor for peri- and postoperative complications in colorectal surgery~     (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining~     measures that can prevent readmission for dehydration and other nutritional considerations~     related to this group of patients is definitely required.~      Hypothesis:~      The administration of an oral rehydration solution will allow a significant decrease in~     dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.~   "
78010|NCT02036333|"~     The purpose of this study is to determine whether there is a difference in cerebral~     oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and~     healthy controls.~   "
78011|NCT02036320|"~     The purpose of this clinical trial is to compare the overall lens fit acceptance of two~     different soft contact lenses in an Asian population.~   "
78012|NCT02036307|"~     This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the~     other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood~     pressure, and fasting triglyceride levels.~   "
78013|NCT02036294|"~     This study involves development and testing of a patient and family-centered transitional~     care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease~     (COPD) exacerbations. The study intervention includes tailored services to address~     individual patients' biopsychosocial needs, starting early during hospital stay and~     continuing for 3 months post hospital discharge.~      The study hypothesis is that compared to usual care, the study intervention will : a)~     Improve patient health- related quality of life and survival, and reduce use of hospital and~     emergency room visits; b) result in improved patient experience, self- confidence, and~     self-care behaviors; c) result in improved family caregivers coping skills, self-confidence,~     and problem solving skills to address patient barriers to care and treatment.~   "
78014|NCT02036281|"~     The subjects will be treated with a single dose of SP-SAP. They will receive the study drug~     SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and~     required to stay in the hospital for 24 hours for precautionary care. Their vital signs will~     be monitored and recorded immediately following the injection. After the catheter has been~     removed, the following assessments will be made physical exam including motor and sensory~     functions, and electrocardiogram. A neurologist will be available for consultation as~     needed.~      Beginning dose of SP-SAP will be 1 -mcg for the first cohort.~      Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into~     the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities~     between cohorts.~      Study duration will be up to 6 months from the start of SP-SAP administration.~   "
78015|NCT02036268|"~     This is a randomized study of standard versus extra ostomy education.~   "
78016|NCT02036255|"~     The objective of our study is to investigate whether the substitution of the standard~     locking solution with a locking solution containing taurolidine and urokinase weekly~     (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in~     hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.~   "
78017|NCT02036242|"~     It is common for obstetric anesthesia using opioid supplement to local anesthetics for~     epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the~     necessity of the supplement of opioid to lacal anesthetics during this process based on the~     concept that opioid addition can enhance and prolong the analgesic effect of local~     anesthetics. However, we unavoidably encounter many opioid-associated side effects during~     the labor delivery. In addition, usage of opioid increase the medical cost for each patient.~     We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics~     can produce as the same analgsic effect as opioid plus local anesthetics given for epidural~     labor pain control.~   "
78018|NCT02036229|"~     The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the~     treatment of demodicidosis (including papulopustular rosacea)~   "
78019|NCT02036216|"~     Circulating free cell DNA (cfDNA) is extracellular fragmentation of nucleic acids that~     occurs both in plasma and serum. This kind of DNA which derived from the apoptotic/necrotic~     cells or the lysis of circulating tumor cells (CTCs) can be detectedin the patients with a~     variety of diseases. Emerging evidence suggests that cfDNA from patients exhibits~     characteristicchanges of tumors, suchas mutations, insertions/deletions,~     methylations,microsatellite aberrations, and copy number variations, etc. All of these~     reveal a visible difference between the benign conditions, and thus may be useful in the~     diagnosis of cancer, identification of targeted therapy, monitor responses to treatments,~     and early detection of relapse. The purpose for this study is to explore these~     characteristic changes in the patients withhepatocellular carcinoma (HCC) and expect to~     guide targeted therapy and identify non-invasive biomarkers of cancer diagnosis and~     prognosis which can be easily isolated from the circulation.~   "
78020|NCT02036203|"~     This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD~     compared to the standard T shaped copper IUD, the TCu380.~      Participants will be followed for one year and quality of life measurements will be measured~     during this period as well.~   "
78021|NCT02036190|"~     The long-term objectives of this ancillary application are to characterize a subpopulation~     of smokers with auto-reactive T cell response, to validate immunodiagnostic assays that~     could detect emphysema, and to find molecular signatures for pathogenic T cell development~     in a well-characterized cohort participating in SPIROMICS (UCSF center).~   "
78022|NCT02036177|"~     The SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in~     comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper:~      Comparison of objective parameters - Pregnancy rate, perforation, expulsion and malposition~     rates, changes in the endometrial thickness, rate of complications such as infection and~     anemia and discontinuation rates after 1 year.~      Comparison of Subjective parameters - pain during insertion, menstrual characteristics and~     pain, bleeding in correlation to the bleeding pattern prior to insertion.~      Physician opinion: ease of use in insertion and removal. Subject satisfaction.~      It is expected that subjects using the copper IUB will demonstrate less safety events, equal~     effectiveness and equal or improved menstrual bleeding and pain related profiles compared~     with users of the T shaped copper IUD.~   "
78023|NCT02036164|"~     Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation~     (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We~     will investigate if ACT has survival benefit over CCRT alone.~   "
78024|NCT02036151|"~     The study was designed to determine whether maternal xylitol consumption through regular~     chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and~     dental plaque levels of their children.~   "
78025|NCT02036138|"~     The growing incidence of obesity and type2 DM globally is widely recognized as one of the~     most challenging contemporary threats to public health. Uncontrolled diabetes leads to~     macrovascular and microvascular complications, including myocardial infarction, stroke,~     blindness, neuropathy, and renal failure in many patients. The current goal of medical~     treatment is to halt disease progression by reducing hyperglycemia, hypertension,~     dyslipidemia, and other cardiovascular risk factors. Despite improvements in~     pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually~     achieve and maintain therapeutic thresholds, particularly for glycemic control.~     Observational studies have suggested that bariatric or metabolic surgery can rapidly improve~     glycemic control and cardiovascular risk factors in severely obese patients with type 2~     diabetes Few randomized, controlled trials have compared bariatric surgery with intensive~     medical therapy, particularly in moderately obese patients (defined as those having a BMI of~     30 to 34.9) with type2 DM. Accordingly, many unanswered questions remain regarding the~     relative efficacy of bariatric surgery in patients with uncontrolled diabetes. This~     randomized, controlled, prospective multicenter study was designed to compare intensive~     medical therapy with surgical treatment (LRYGB or LSG) as a means of improving glycemic~     control in moderately obese patients (BMI 30-34.9) with type- 2 DM.~   "
78026|NCT02036125|"~     The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid~     injection in reducing symptoms caused by carpal tunnel syndrome.~   "
78027|NCT02036112|"~     An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision~     (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE~     versus Individual ELAPE.~   "
78028|NCT02036099|"~     Based on the literature on dementia and driving, and on knowledge tools available to date~     including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will~     be adapted and tailored to guide physicians in their decisions to report a driver with mild~     dementia to the provincial licensing agency. The DMD-DT intervention will include a) an~     algorithm-based computerized clinical decision support system (CCDSS) for facilitating~     driving assessment and physicians' reporting to provincial transportation authorities, b) an~     individualized educational package for patients and caregivers about dementia and driving~     and driving cessation, and c) a modified reporting form to provincial driving regulatory~     authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the~     input of the co-investigators and knowledge-users who represent the perspectives of~     physicians, patients and their caregivers, as well as transportation authorities. Pilot~     testing will be done, and input from focus groups of knowledge-users will refine the~     intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT.~     Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to~     compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting~     to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will~     be further explored in focus groups and interviews with physicians. Months 19-24: The~     knowledge obtained from the study will be used to generalize and sustain use of the~     intervention beyond Ontario, Canada, and to disseminate the information to knowledge-users.~     The primary outcome measure is the filing of a report to the Ministry of Transportation of~     Ontario, indicating that the physician has a concern about the patient's health condition~     (i.e. mild dementia). The primary outcome of the study is the difference in reporting~     between the DMD-DT and control arms. Since the current reporting rate is low, approximately~     13%, from a public health point of view, the primary outcome expected is that physicians in~     the DMD-DT group will report more patients with mild dementia than those in the control~     group.~   "
78029|NCT02036086|"~     This study will evaluate the clinical and pathological response to vemurafenib and~     cobimetinib in the neoadjuvant treatment of patients with histologically confirmed, BRAF~     V600 mutation-positive Stage IIIB and C melanoma. 20 patients will be treated with~     vemurafenib and cobimetinib for 2 months. Then they will be assessed for surgery. Patients~     will undergo surgery and subsequently resume taking vemurafenib and cobimetinib after~     recovery from surgery. Patients will undergo radiation therapy if appropriate then continue~     vemurafenib and cobimetinib. The maximum treatment period is 12 months. After 12 months of~     treatment, patients will be followed for disease recurrence and survival during for a total~     of 5 years.~   "
78030|NCT02036073|"~     EPO has been safely used for prevent preterm anemia and recent studies have shown the~     neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The~     aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg~     higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on~     neurodevelopment in preterm infants; to detect biological indicators and explore the~     neuroprotective mechanism of EPO.~   "
78031|NCT02036060|"~     Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading~     cause of men cancer death in the United States. Hormonal therapy remains a first-line~     treatment for metastatic prostate cancer. Initial responses to hormonal therapy with~     chemical or surgical castration are quite favorable, however, most patients will progress to~     a castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic~     option for patients with mCRPC.~      Abiraterone is a novel, selective, irreversible, and potent inhibitor of~     17-[alpha]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been~     demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1~     ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone~     demonstrated activity in castration resistant prostate cancer patients previously treated~     with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone~     plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis,~     castration-resistant metastatic prostate cancer patients, demonstrated a better radiological~     progression free survival for abiraterone treated patients and a trend towards a better~     survival was clear for abiraterone treated patients.~      No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy~     combination. All trials have been performed in patients in which LHRH agonist treatment was~     continued although there is not clear evidence about efficacy of hormonal treatment. Some~     retrospective studies suggest that androgen deprivation treatment should be maintained in~     chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to~     negative values, and to add efficacy to castration hormonal therapy. Combination of~     abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel~     chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to~     docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems~     promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.~   "
78032|NCT02036047|"~     The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal~     polyps, resulting in an increase in the complete resection rate and a decrease in the~     adverse events.~   "
78033|NCT02036034|"~     The investigators hypothesize that this modified ophthalmic draping will reduce the~     accumulation and rebreathing of carbon dioxide during eye surgery.~   "
78034|NCT02036021|"~     Mortality related with cardiac arrest in anesthetized children has diminished over several~     decades from 2.9 per 10000 anesthesias in 1961 to 0.21 per 10000 anesthesias in 2007.(1)~     Even though the mortality rate related to pediatric anesthesia is much lower than before,~     respiratory complications related with peri-operative cardiac arrest are as high as 27%~     according to the Pediatric Peri-operative Cardiac Arrest (POCA) Registry.(2).Therefore,~     peri-operative respiratory event (PRE) in pediatric anesthesia such as laryngospasm,~     stridor, bronchospasm, desaturation and reintubation are crucial.~      Stridor and reintubation occur after the children are extubated, mostly in the PACU period.~     Laryngospasm, stridor, bronchospasm and wheezing can lead to desaturation and the need for~     reintubation. Those PRE, especially peri-operative desaturation, can prolong PACU stay~     especially if PRE develops in the PACU.(8,9) PRE occurring during the intraoperative period~     can also prolong PACU stay if children are observed at PACU and not transferred directly to~     the intensive care unit (ICU). Some children require oxygen therapy in the PACU and continue~     at the ward. Some need endotracheal tube intubation with spontaneous breathing or are placed~     on mechanical ventilator. Thai AIMS (10) reported that desaturation at PACU was associated~     with re-intubation, prolonged mechanical ventilation and unplanned ICU admission. Oxygen~     supplement need, prolonged mechanical ventilation or unplanned ICU admission can produce~     extra days of hospitalization or increase the cost of hospitalization from extra-cost~     payment eg; oxygen therapy, mechanical ventilator, cost of ICU stayed.~      Furthermore, the short-term sequelae regarding cost of hospitalization of children who~     develop PRE has never been evaluated or compared with the cost in children who do not~     develop PRE. Higher cost of hospitalization after occurrence of PRE in anesthetized children~     will have an impact to the hospital policy maker. Minimizing PRE can save on the cost of~     hospital care to the public hospital or other health sectors.~      Therefore, we would like to compare days of hospitalization and cost differences of~     hospitalization between children who develop PRE and children who do not develop PRE at a~     tertiary care hospital in southern Thailand~   "
78035|NCT02036008|"~     The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a~     useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver~     metastases compared to the standard agent gadobutrol (EcGd, Gadovist).~   "
78036|NCT02035995|"~     Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes~     and it is responsible for the morbidity of both mother and child. The aim of this study was~     to determine retinal findings of gestational diabetes mellitus (GDM).~   "
78037|NCT02035982|"~     There are few pharmacological treatments available for Alzheimer's disease, including drugs~     called cholinesterase inhibitors: donepezil, galantamine, and rivastigmine. In research~     trials, cholinesterase inhibitors have been shown to improve memory and problem behaviours~     in people with mild to moderate Alzheimer's disease. However, these benefits may not extend~     to the real-world when taking into account nursing home and health care costs. There is less~     information on the use of cholinesterase inhibitors in people with severe Alzheimer's~     disease. In Canada, only donepezil is recommended for the treatment of severe Alzheimer's~     disease. However, there is no information on whether the benefits that donepezil provides to~     people with severe Alzheimer's disease are sustained over the long term. Moreover, while the~     tolerability of cholinesterase inhibitors is generally acceptable, their use is not~     completely harmless. Common side effects include nausea, diarrhea, insomnia, vomiting,~     muscle cramping, fatigue and loss of appetite.~      In Ontario, cholinesterase inhibitor users tend to remain on these medications for two years~     or more and often until death. The current cholinesterase inhibitor guidelines provide~     details on what medication should be used, when it should be started and how it should be~     monitored, but there is less clarity on when it is safe and appropriate to stop treatment.~     The cessation of cholinesterase inhibitors in patients no longer appearing to display any~     clear benefits may help to lower the risk of unpleasant side effects, lower the use of~     multiple medications, and reduce the costs of caring for individuals with Alzheimer's~     disease. However, the cessation of cholinesterase inhibitor therapy may run the risk of~     deterioration in memory, worsening or development of behavioural symptoms and the placement~     of additional demands on professional and unpaid caregivers.~      There is a clear need for guidelines when to stop cholinesterase inhibitor treatment,~     especially for patients in whom the benefits of not be on the medication will outweigh the~     risks. The purpose of this study is to address this issue by collecting data which may be~     helpful in predicting which types of patients may benefit from stopping cholinesterase~     inhibitor treatment. Understanding when, and for whom, it is appropriate to stop~     cholinesterase inhibitor treatment will influence the field of pharmacology in the treatment~     of Alzheimer's disease.~   "
78038|NCT02035969|"~     This project aims to assess the effect of group peer support to children with HIV in~     relation to adherence, virological treatment failure as well as physical development. A~     randomised controlled trial (RCT) will be used where HIV+ children on antiretroviral~     treatment (ARV) and their caretakers are randomized into either enhanced treatment support~     (ETS) through peer supporters or the conventional treatment (CT) according to the guidelines~     of The National AIDS Control Program. The treatment strategies will be assessed and compared~     in relation to virological treatment failure as primary endpoint, immunological and clinical~     (AIDS events and mortality) as secondary endpoints as well as treatment adherence and~     physical development. The results from this project will lead to an increased knowledge in~     relation to the impact of enhanced treatment support on adherence, virological suppression~     and resistance development for children with HIV and have an impact on HIV treatment~     policies and guidelines for Pediatric HIV in low-income settings globally.~   "
78039|NCT02035956|"~     Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of~     intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or~     without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma~   "
78040|NCT02035943|"~     In this study the investigators want to comare safety and efficacy of two different metods~     to administrate insulin during parenteral nutrition.~   "
78043|NCT02035904|"~     The aim of the study is to evaluate efficacy and safety of long term (14 days) wound~     infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with~     immediate breast reconstruction: this is a double blind, randomized, parallel group study.~     The study moves from the concept that nociceptive stimulus last further than 48 hours after~     surgical intervention: long term analgesia is necessary to provide a real benefit to the~     patient and provide central sensitization. Intralesional catheter is placed at the end of~     surgery. In the first 24 postoperative hours we provide continuous wound infusion with~     levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4.~     From the second postoperative day morphine PCA is removed and patients are randomized to~     receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours,~     with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination~     (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after~     36 hours of non-use.~      Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed;~     pain physicians also care about any catheter-related or drug-related side effect,~     registering number of total boluses. Patients are provided with a home diary for pain scores~     to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3~     month is performed to investigate pain chronicization.~      Surgical evaluation is provided, also to establish any catheter-related infective or healing~     complication.~      Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure~     rehabilitation process.~      A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to~     understand differences in return to a normal quality of life and to social activities~     between the two groups.~   "
78044|NCT02035891|"~     The study aims to assess：~        1. whether low-dose colchicine could reduce microalbuminuria in patients with type 2~          diabetes and microalbuminuria who have been receiving stable treatment of~          angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) for~          at least 3 months;~        2. whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients~          with type 2 diabetes and microalbuminuria;~        3. whether low-dose colchicine slows the progression of microvascular complications in~          patients with type 2 diabetes and microalbuminuria;~        4. whether low-dose colchicine reduces the risk of cardiovascular events in patients with~          type 2 diabetes and microalbuminuria.~   "
78045|NCT02035878|"~     The proposed project will investigate the effects of probiotics on anxiety and associated~     psychological and physiological factors in humans. The therapeutic potential of probiotics~     for reducing anxiety and other factors associated with a disrupted microbiome will be~     assessed in a double-blind placebo-crossover design. Based on the research findings to date,~     it is hypothesized that probiotics will reduce anxiety and depressive symptoms.~   "
78046|NCT02035865|"~     The investigators aim at characterizing neuropsychiatric consequences of heart~     transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on~     mortality and cardiac allograft vasculopathy (CAV).~   "
78047|NCT02035852|"~     The study will compare two different size MRI's of a brain tumor.~   "
78048|NCT02035839|"~     To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3~     different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.~   "
78049|NCT02035826|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite~     strong evidence that reducing low-density lipoproteins (LDL) with statins successfully~     lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment~     when indicated, and more than 50% of patients stop taking statins within one year of ﬁrst~     prescription though such therapy typically should be life-long. In this study, we will test~     the effectiveness of different financial incentives in increasing statin use and reducing~     LDL cholesterol among patients with poor cholesterol control who are at very high risk for~     CVD. The application of conceptual approaches from behavioral economics offers considerable~     promise in advancing health and health care. We will test these approaches among patients at~     very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm,~     cluster-randomized controlled trial, we aim to answer these questions: [1] How does the~     provision of patient incentives compare to no incentives at all? [2] Is success with patient~     incentives improved by increasing the financial amounts? [3] Are results sustained after~     incentives and other interventions are withdrawn?~      Study Objectives and Hypothesis~      Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL~     cholesterol relative to usual care during a 3-month intervention among patients at high risk~     of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL~     cholesterol.~      Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control~     in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more~     effective than lower incentive amounts.~      Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and~     reduced LDL after the 3-month intervention period.~      Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more~     effective than others and to address other factors relevant to broader implementation.~   "
78050|NCT02035813|"~     Several studies have indicated that determining prevalence and number of circulating tumor~     cells (CTCs) at various time points during treatment may be an effective tool for assessing~     treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value~     of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in~     predicting treatment response needs further investigation. DETECT IV is a prospective,~     multicenter, open-label, phase II study in patients with HER2-negative metastatic breast~     cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on~     CTC dynamics and characteristics will provide a better understanding of the prognostic and~     predictive value of CTCs and is one step into a more personalized therapy for MBC.~   "
78051|NCT02035800|"~     Broca II is the prolongation of the original study name BROCA. In BROCA study, only 25~     patients participated and it was not enough to concluded clearly our hypothesis.~   "
78052|NCT02035787|"~     Purpose: This is an open label, single-arm, single-center study of the addition of metformin~     to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable~     non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1~     endometrial adenocarcinoma (EC; n=15).~      Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not~     candidates for surgical management, and therefore are planned to start standard of care~     treatment with the LR-IUD~      Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until~     disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial~     endometrial biopsies will be performed, as per standard of care, to assess disease status.~   "
78053|NCT02035774|"~     Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate~     their hand and forearm which may hamper optimal positioning for surgery of the dorsal side~     of the hand. The investigators think that this supination is caused by lateral rotation in~     the shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is~     innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal~     positioning of the hand for surgery on the dorsal side of the hand may be achieved by~     performing a SSN block (SSNB) in addition to the LSIB.~   "
78561|NCT02029105|"~     In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin,~     C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in~     combination, in distinguishing malignant pleural mesothelioma patients from patients with~     metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos~     pleurisy.~   "
78054|NCT02035761|"~     Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA~     there is degeneration (progressive loss) of nerve cells in several brain and spinal cord~     regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia,~     incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual~     dysfunction) to sleep problems (dream enactment, sleep apnea).~      This research aims to help us better understand the patterns and timing of nerve~     degeneration relatively early in the disease, and how this affects symptoms and progression.~     For instance:~        1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity~          of loss of heart nerves affect disease progression and survival?~        2. It is thought that MSA does not affect memory and thinking much, unlike other diseases~          (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit~          acetylcholine (a neurochemical important in mental functioning)?~        3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system~          in the brain? How does this relate to symptoms that subjects report in these often~          underappreciated areas?~      To answer these and other questions, investigators will take images of specific nerves in~     the brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us~     information that cannot be obtained from MRIs and CT scans. We will measure the levels of~     several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also~     have many standardized assessments including quality-of-life and symptom assessments,~     neurological examination, autonomic assessments, neuropsychological assessments,~     coordination tests, and even assessments of vision and sense of smell. By pooling these~     results from many MSA patients, and comparing with other diseases (such as Parkinson's~     disease) we hope to gain a better understanding of what is happening early in MSA. Such~     knowledge could be very valuable in future efforts to develop better therapies in this rare~     disease.~   "
78055|NCT02035748|"~     The purpose of this study is to observe the anatomical and functional outcomes of~     ocriplasmin (JETREA®) over a 6-month follow-up period.~   "
78056|NCT02035735|"~     The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the~     superficial extension of these tumors.~   "
78057|NCT02035722|"~     Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for~     patients with wet age-related macular degeneration (AMD) An disadvantage of this technique~     is the anxiety and discomfort which patients often experience due to the idea of getting a~     needle in the eye. In addition, a recent case study indicated the importance of patient~     education in achieving positive outcomes from intravitreal injections of anti-vascular~     endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether~     visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the~     treatment, and lessen the impact of socioeconomical status on their understanding of the~     treatment and prognosis.~   "
78058|NCT02035709|"~     Treatment of postoperative pain with hydromorphone (a strong analgesic) using~     patient-controlled analgesia with target concentrations in blood compared to conventional~     patient-controlled analgesia after planed cardiac surgery~   "
78059|NCT02035696|"~     To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to~     < 48 months of age~   "
78060|NCT02035683|"~     The purpose of this study is to test whether an early metabolic response, measured by PET/CT~     scan after the first cycle of chemotherapy, is able to predict which patients with advanced~     NSCLC have a better prognosis.~   "
78061|NCT02035670|"~     The purpose of this study is to determine whether two-step method of diagnostic strategy is~     effective in the diagnosis and treatment of fever of unknown origin (FUO). (TSMD research, a~     pilot study) Fever of unknown origin (FUO) is a fever in excess of 38.3◦C continued for more~     than 3 weeks, and its cause could not be identified by tests during hospitalization for more~     than 1 week [1]. As diagnostic techniques such as imaging technology and clinical tests have~     been developed and outpatient access to diagnostic tests have improved, the FUO is defined~     as a shortened period where the cause could not be revealed despite diagnostic tests during~     three visits to the outpatient department or during 3 days of hospitalization [2]. FUO can~     be caused by many diseases, and causes can vary depending on region and time period. FUO was~     first reported in the medical literature 80 years ago. Since then, the causative diseases~     have greatly changed with changes in the social environment and widespread use of diagnostic~     imaging. The causes of FUO, according to traditional diagnosis and treatment, could be~     divided into four principal groups: infections, non-infectious inflammatory diseases (NIID,~     including rheumatic diseases and vasculitic diseases), neoplasms, and other diseases.~     Despite the development of various diagnostic techniques, 34-51% of FUO patients remain~     undiagnosed [3,4]. In China, over-reliance on antibiotics for disease therapy and infection~     prevention are common phenomena in traditional treatment of FUO[5].~      Two-step method of diagnostic strategy is a method to diagnose FUO disease. First step is to~     differentiate FUO according to the onset of disease and invasive pathogens. Second step is~     to further differentiate FUO according to trends of disease and inflammation scores. The~     diagnosis of FUO can be difficult for both patients and their physicians. Depending on the~     experience and qualifications of the treating physicians, time to reach a diagnosis can~     vary. Two-step method of diagnostic strategy would afford a standard method for physicians~     to diagnoses the FUO.~      So many reports of FUO have also been published in China, but have been limited to~     single-facility or limited-region studies; no nationwide studies have yet been conducted.~     Moreover, few assessments of tests used in the diagnostic evaluation of FUO have been~     reported. In particular, few studies have assessed the clinical usefulness of tests such as~     serum procalcitonin or positron emission tomography (PET) in China, although these tests are~     now frequently used.~      We therefore will conduct a multicenter collaborative retrospective and prospective~     （randomized and controlled ）study of patients with FUO at hospitals affiliated with China's~     Ministry of Health. This is the first nationwide study in China on diseases causing FUO and~     the diagnostic workup, and identified diseases that should be considered when evaluating FUO~     in China. In addition, we will investigate the rate of performing various tests in the~     current diagnostic workup of FUO.~      Classical FUO was diagnosed based on the definition by Durack et al[6] in patients meeting~     all of criteria 1-4 below.~      1. Fever with axillary temperature ≥38°C at least twice over a ≥3-week period. 2. Unknown~     cause after three outpatient visits or during 3 days of hospitalization.~      3. Not diagnosed with immunodeficiency before fever onset. 4. No confirmed HIV infection~     before fever onset. The data described below were collected. No additional testing was~     performed in this study due to insufficient data.~        1. Patient characteristics: sex, age, concomitant disease, medical history and medication~          history.~        2. Clinical findings: subjective symptoms and objective physical findings.~        3. Blood tests: blood count, biochemical examination and inflammatory markers (C reactive~          protein (CRP), erythrocyte sedimentation rate (ESR), procalcitonin, etc.).~        4. Results of blood cultures if performed.~        5. Results of imaging studies and endoscopy if performed.~        6. Results of cytology, histology, genetic testing or autopsy findings if performed.~        7. Final diagnosis, day of diagnosis and outcome. This study is safety for no drug~          involved to determine the effectiveness of two-step method of diagnostic strategy in~          the diagnosis and treatment of fever of unknown origin.~   "
78062|NCT02035657|"~     This is a single arm, open-label, single center study evaluating the safety, feasibility,~     clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell~     carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own~     immune system in attacking the cancer cells.~   "
78063|NCT02035644|"~     The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in~     patients with inadequately controlled type-2 diabetes and dyslipidemia under life style~     intervention.~   "
78064|NCT02035631|"~     The main purpose of our study is to assess the effect of a lifestyle intervention combining~     weight control, diet and physical activity on the risk of recurrences among breast cancer~     patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.~   "
78065|NCT02035618|"~     Manual therapy combined with a protocol of therapeutic exercises will increase the~     beneficial effects on scapular kinematics, myofascial pain and function in subjects with~     shoulder impingement when compared to exercises only.~   "
78066|NCT02035605|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.~   "
78067|NCT02035592|"~     The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried~     blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk~     factors, and lung and cognitive function in overweight and obese participants with metabolic~     syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline~     and at 6-months).~   "
78068|NCT02035579|"~     Sports-related concussions are common in adolescent-athletes. Prolonged recovery after~     concussion or post-concussion syndrome (PCS) is a public health problem. This project will~     determine the effectiveness of an aerobic exercise program for management of PCS and it will~     evaluate the influence of exercise on biologic correlates of PCS.~   "
78069|NCT02035566|"~     People living in rural areas are at increased risk for poor health outcomes due to: long~     distance to health care facilities, less available health care resources such as primary~     care and specialty services, transportation problems, higher elderly population, poverty,~     high uninsured rates and the lack of timely access to new technologies. Called Telehome Care~     (THC), in the form of equipment in the home, may provide an innovative and potentially~     cost-effective solution to enhancing chronic disease management services using technology~     and may influence the reduction in emergency department (ED) visits and hospitalizations in~     rural areas. However, telehealth research is still in its infancy, it is not well~     understood, and is often done without an overarching scientific framework. The provision of~     in home health monitoring and health education also may be a potential population based~     health research tool for chronically ill patients. Demonstration of the possible benefits,~     patient acceptance and satisfaction with THC requires a scientific approach as is used in~     this study.~   "
78070|NCT02035553|"~     This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo~     in patients with Alzheimer's disease psychosis.~   "
78105|NCT02035046|"~     Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene~     coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the~     chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to~     normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to~     determine whether the heterozygous carriers present the metabolic risks and/or the benefits~     of this disease.~   "
78071|NCT02035540|"~     This is a prospective, non-randomized, single-arm, multicentre surveillance study to be~     conducted in Europe. The Surveillance is designed as a study, where~        -  ESPOIR PV (pulmonary valve) is prescribed in the usual manner in accordance with the~          terms of the approval.~        -  The assignment of the patient to a particular therapeutic strategy is not decided in~          advance by this Surveillance Protocol but falls within current practice and the~          prescription of ESPOIR PV is clearly separated from the decision to include the patient~          in the Surveillance.~        -  No additional diagnostic or monitoring procedures shall be applied to the patients~        -  and epidemiological methods shall be used for the analysis of collected data.~      Evaluation of decellularized human heart valves for pulmonary heart valve replacement in~     comparison to current valve substitutes. Safety endpoints include cardiovascular adverse~     events, time to re-operation, re-intervention and explantation. Efficacy endpoints include~     freedom from valve dysfunction and hemodynamic performance.~   "
78072|NCT02035527|"~     This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and~     docetaxel when given together with cisplatin and to see how well they work in treating~     patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs~     used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by~     making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and~     docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.~   "
78073|NCT02035514|"~     Immunomodulatory therapies to treat the relapsing-remitting phase of multiple sclerosis (MS)~     are designed to ameliorate the inflammatory processes that mediate the damage to the central~     nervous system (CNS) and to delay progression of the disease. To date, there is no effective~     means to stop the progression of disease and induce remyelination. Adult stem cells therapy~     show great promise and is rapidly developing as alternative therapeutic strategy. We propose~     the use of bone marrow-derived autologous Mesenchymal (BM-MSC) Stem Cells transplantation to~     treat patients with relapsing-remitting MS (RRMS), despite immunomodulatory therapy. Taking~     advantage of the potential that MSC possess strong immunomodulatory properties thought to~     play a role in the maintenance of peripheral tolerance and in the control of autoimmunity~     and that may stimulate repair and regeneration of lesions, we plan a trial of a single~     injection of autologous BM-MSC into eight patients. First, we aim to assess the feasibility,~     safety and tolerability of autologous MSC therapy in RRMS. Second, we plan to evaluate the~     effects of BM-MSC transplantation on MS disease activity by clinical, neurophysiological,~     immunological and imaging assessments. Autologous MSC will be obtained from bone marrow~     aspirates, purified by culture and characterized by surface antigen expression. A single~     dose of autologous BM-MSC will be injected intravenously. Clinical, neurological and~     immunological assessments will be scheduled at baseline (before BM-MSC transplantation) at~     1, 3, and 6 months after transplant. The imaging will be performed at 3 and 6 months after~     transplant. Proposed trial will enable us to ascertain whether autologous BM-MSC~     transplantation is a feasible and safe procedure, and whether BM-MSC can establish an~     environment of immune tolerance and through the local production of neurotrophic/growth~     factors, might induce neuroprotection and improvement in CNS function.~   "
78074|NCT02035501|"~     The purpose of the study is to investigate if treatment with L-Tyrosine improves selected~     outcome measures of TNNT1 myopathy.~   "
78075|NCT02035488|"~     Bronchiectasis is a persistent and frequently progressive condition characterized by dilated~     and thick-walled bronchi retaining sputum. The main symptoms of bronchiectasis are cough and~     chronic sputum production. Until now, most patients with non-CF bronchiectasis receive~     inhaled tobramycin every other month, by use of a nebulizer. However, this delivery system~     has several disadvantages, like a low lung deposition and pollution with tobramycin in the~     surrounding environment. With an efficient dry powder inhaler (DPI), a three to six fold~     higher lung deposition compared to a nebulizer can be obtained. Therapy with a DPI is also~     less time consuming compared to nebulisation. We will investigate dry powder tobramycin (DP~     tobramycin) in a novel device in patients with non-CF bronchiectasis. The main objectives of~     this study are to investigate the pharmacokinetic properties of DP tobramycin at different~     dosages together with the local tolerability of DP tobramycin via the Cyclops® at different~     dosages.~   "
78076|NCT02035475|"~     The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da~     Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical~     transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of~     the instrument. Their use in this study will be to perform tissue transection during PLND~     such that the intended use is within the FDA-approved domain for this instrument.~     Investigators intend to identify whether its use for PLND reduces lymphoceles given that the~     device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels~     encountered during PLND. Because the instrument is new and has been FDA approved for less~     than one year, there is no published literature regarding its use to date.~      Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce~     the incidence of screening detected lymphoceles on that side. Investigators propose a total~     sample size of 120 patients.~   "
78077|NCT02035449|"~     Difficult conditions and critically ill and injured patients may complicate endotracheal~     intubation in the pre-hospital setting. The incidence of complications increase when two or~     more endotracheal intubation attempts are needed.~      The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal~     intubation after the introduction of the McGrath MAC Video laryngoscope as the primary~     airway device for pre-hospital endotracheal intubation.~      Hypothesis:~      • In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the~     rate of difficult PHETI (defined as more than one intubation attempt needed to secure a~     patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in~     pre-hospital intubations.~   "
78078|NCT02035436|"~     Through many years, the standard care has been to use continuous sedation of critically ill~     patients during mechanical ventilation. However, preliminary randomised clinical trials~     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA~     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,~     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway~     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical~     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at~     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation~     on delirium during admission and cognitive function after discharge from ICU.~      Our hypothesis is that critically ill patients who are not sedated during mechanical~     ventilation will have better cognitive function after discharge.~   "
78079|NCT02035423|"~     The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high~     school students of both genders from different districts of Tehran, the Iranian capital, in~     winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of~     the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that~     contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of~     vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D~     levels were checked in a subgroup before and after the intervention.~   "
78080|NCT02035410|"~     Cardiovascular implantable electronic device (CIED) infections have been increasing out of~     proportion to the number of devices implanted We investigated recent trends and possible~     causes of the increasing numbers of Cardiovascular implantable electronic device infections.~   "
78081|NCT02035397|"~     One possible angle for treating obesity could be slowing down the gastric emptying time. By~     prolonging the gastric emptying time, the person would ideally experience increased~     sensation of satiety, and in the long run reduce food intake. If such a treatment provides a~     clinically significant weight loss, this could be an alternative for surgical procedures,~     avoiding the risk for perioperative complications as well as complications in the long run.~      There are now several pilot studies documenting that intragastric treatment with botulinum~     toxin A (BTA) can be effective, although the treatment perspective is short and do not~     include repeated injections. However, they demonstrate that BTA-injections are safe for the~     patient. The treatment is administered by endoscopy.~   "
78082|NCT02035384|"~     This study is conducted in Europe, and North and South America. The aim of this study is to~     provide additional documentation of the immunogenicity, and obtain additional clinical data,~     of turoctocog alfa in the setting of normal clinical practise in patients previously treated~     with a factor VIII agent (FVIII).~   "
78083|NCT02035371|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetic (the exposure of the trial drug in the body) properties of FIAsp~     (faster-acting insulin aspart) in children, adolescents and adults with type 1 diabetes.~   "
78084|NCT02035358|"~     In this Phase 1 Trial investigators plan to establish the MTD of HyperAcute®-Renal (HAR)~     immunotherapy in subjects with clinically metastatic renal cell carcinoma.~   "
78085|NCT02035345|"~     This is a research study to determine if administering carboplatin at a slower rate when~     re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity~     reaction will decrease the frequency and severity of future hypersensitivity reactions.~   "
78086|NCT02035293|"~     A standardized diagnostic strategy of pulmonary embolism will be applied to eligible~     patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer~     assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of~     the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be~     followed for 3 months.~   "
78087|NCT02035280|"~     As the population continues to age, the prevalence of spinal deformity surgery for older~     patients is increasing. Questions regarding the suitability of these patients to undergo~     large spinal procedures and whether the outcomes merit the risks involved are not well~     known.~   "
78088|NCT02035267|"~     The objectives of this study are to explore the safety and efficacy of subcutaneous~     injections of ATX-101 relative to placebo, in the submental area.~   "
78089|NCT02035254|"~     In this project, individuals at risk for cardiovascular disease who are looking to lose~     weight or increase your level of activity, are offered access to an online lifestyle~     management program.~      Participants will use the website daily to improve their eating and exercise habits as well~     as other aspects of healthy living. They will be asked to participate in online challenges~     to motivate them to make lifestyle changes. Participants will meet with a health~     professional 3 times within the 6 month time period as well as receive monthly guidance and~     support by phone or email for the website.~   "
78090|NCT02035241|"~     The purpose of the study was to investigate how herbs and spices affect acute/postprandial~     glucose and insulin responses, inflammatory markers, appetite control peptides,~     antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales)~     in healthy volunteers. We hypothesize that certain herbs and spices added to a standardized~     meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy~     volunteers, compared with a similar meal without the corresponding plant materials.~   "
78091|NCT02035228|"~     The purpose of this study is to determine whether transcutaneous electrical stimulation~     applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to~     reduce hyperinflation in patients with chronic obstructive pulmonary disease.~   "
78092|NCT02035215|"~     The purpose of this study is to evaluate the efficacy and safety of combination therapy of~     omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia~   "
78093|NCT02035202|"~     The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive~     behavioral intervention for serious mental illness (SMI) and to identify the facilitators,~     barriers, and costs of implementation. We would like to determine whether the addition of a~     mobile phone monitoring software program to a brief behavioral intervention for bipolar~     disorder or schizophrenia improves symptoms arising from the disorders. In this study we~     will be assessing the feasibility, acceptability and short term effect of the mobile phone~     enhanced intervention for bipolar disorder and schizophrenia.~   "
78094|NCT02035189|"~     An observational study in evaluating the clinical impact of procalcitonin on the care of~     Stem cell transplant recipient and its performance as an adjunct in the diagnosis and~     prognostication of Infectious processes~   "
78106|NCT02035033|"~     Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone~     mass. The first step in the prevention and treatment of Op is ensuring adequate intake of~     calcium and vitamin D . While calcium supplementations clearly slow bone loss in both~     sexes,their effects on fracture risk are less certain. In contrast to the above a recent~     randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in~     the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women~     receiving calcium supplementation. The mechanism is not clear .we are trying to identify a~     possible correlation between calcium intake and calcium cardiac scoring .~   "
78095|NCT02035176|"~     Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication.~     Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic~     tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule~     (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However,~     this test is subjective, course grained and costly, precluding repeated tests of the same~     child to assess treatment efficacy and large-scale control assessments of typically~     developing (TD) children. For these reasons, the ADOS can impede imaging and genetic~     research.~      In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be~     developed to evaluate distinct autistic behavioral phenotypes, including joint attention,~     empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated~     characters and social scenarios are presented on a computer screen while the responses of~     the child are recorded by video camera, microphone, and eye-tracking equipment. Animations~     are used to test each behavioral phenotype of autism. The long-term vision for OATS is to~     evaluate behavioral and physiological responses of autistic children, including heart rate~     variability, pupil dilation, and EEG. Our first objective is to use existing animations to~     build an OATS Prototype that discriminates autistic from normal children (Aim 1). From~     these results, and use of a defined library of still frame posed images, we will design our~     own animation platform to assess differences between autistic and normal children (Aim 2).~   "
78096|NCT02035163|"~     Atrial fibrillation after coronary artery bypass graft is a common complication.~      The investigators have thought that the mechanism of temporarily postoperative atrial~     fibrillation is closely related to the autonomic nervous system imbalance.~      In a last several years, cryoablation was substituted for atrial incision in many reports to~     simplify the maze procedure.~      However, there has been no comparative study to delineate the feasibility of the use of~     cryoablation.~   "
78097|NCT02035150|"~     Regular breakfast consumption may help lower body weight reduce body fatness and improve~     cardiovascular disease risk factors. However, the best kind of breakfast to consume to~     achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress~     appetite, lower body weight and improve cardiovascular disease risk factors compared with a~     no-fiber breakfast.~   "
78098|NCT02035137|"~     This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)~     and compare their effects on tumor response and associated side effects, to determine if one~     therapy is better than the other for people diagnosed with relapsed or persistent~     neuroblastoma.~   "
78099|NCT02035124|"~     Although there have been advances in the treatment of patients with metastatic~     castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to~     available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the~     post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K~     inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.~   "
78100|NCT02035111|"~     The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule~     treating Migraine Headache.~   "
78101|NCT02035098|"~     The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in~     improving the quality of pain management in hospitalised cancer patients. This is a~     before-after cluster phase II study performed in medicine, oncology and respiratory disease~     hospital wards. The Pac-IFicO programme is a complex interventions with multiple components.~     The primary end-point of the study is the proportion of cancer patients with severe pain.~   "
78102|NCT02035085|"~     Six female patients (>18 years of age, pre-menopausal) who have had loco-regional~     (lumpectomy and radiation) therapy for breast carcinoma and have been at least one-year~     disease free will undergo liposuction, the autologous SVF cell fraction will be isolated and~     labeled with CS-1000 in the operating room without entering cell culture, which will then be~     returned to the patient at the site of breast grafting. Patients will receive a~     pre-screening MRI . Patients will have an MRI scans over a period of 1 month at Johns~     Hopkins. Follow-up MRIs at 6,12, and 18 months will also be performed. Only at Johns Hopkins~     with fluorine being done as part of this investigational study. By performing fluorine MRI~     and quantification of 19F signal, we hypothesize that the engraftment of transplanted cells~     can be tracked in ways not possible before, using the total fluorine signal as surrogate~     marker for cell persistence and survival. We expect that a clinically successful outcome~     (maintenance of breast contour and volume) will be positively correlated with cell survival.~     The outcome of this study may pave the way for using 19F MRI cell tracking as a new tool for~     stem cell therapy in a variety of clinical applications.~   "
78103|NCT02035072|"~     Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus~     oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.~      Protocol code: IRST157.01~      Phase: II~      Study Design: monocentric, prospective, open-label not randomized trial.~      Description of Study Treatment: radio-chemotherapy schedule~        -  GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2,~          every 2 weeks for 4 cycles.~        -  Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session~          per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy~          cycle.~        -  Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.~      Objectives:~      Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary~     objective = the control of IM (internal margin) intra-fraction.~      Step B: primary objective = to evaluate the proportion of the resectable patients after~     radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of~     combinated treatment;overall survival (OS); local progression free survival (LPFS) and~     progression free survival (PFS).~      Statistical Considerations:~      Step A:~      Assuming that the probability to observe a toxicity involving the radiotherapy treatment~     discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for~     toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be~     observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1~     toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more~     patients needs to be recruited. If no further toxicity involving the radiotherapy treatment~     discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.~      If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or~     2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will~     be observed, the study will be stopped because not safe and another kind of radiotherapy~     schedule must be designed.~      Step B:~      If the radiotherapy treatment will be considered no toxic, the study will continue in Step B~     : the goal of this phase II study is to increase the proportion of resectable patients of at~     least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design~     (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years,~     and a further one-year period of follow-up is requested. If at least 7 patients out of 40~     enrolled will be resectable, the hypothesis that the proportion of resectable patients will~     be less or equal to P1 (P1=the proportion of resectable patients with the new~     radio-chemotherapeutic treatment) will be refused and the treatment could be considered~     active.~   "
78104|NCT02035059|"~     The objective of the study is, if an early oral glucose tolerance test combined with~     maternal history, condition and multiple biomarker analysis can be used to detect~     gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).~   "
78107|NCT02035020|"~     The primary objective of this study is to investigate whether the treatment with IFN gamma~     can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by~     pre-clinical evidence in an animal model of the disease.~   "
78110|NCT02034981|"~     This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy~     and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients~     with identified activating molecular alterations in the crizotinib target genes. A cohort is~     defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET~     amplification).~      For each cohort a two-stage design will be implemented. In the situation where expected~     accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors~     will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic~     tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that~     the target number may not be achievable in a reasonable timeframe; for these cohorts, the~     alpha and beta errors will be fixed at 15%. Consequently three different statistical designs~     will be a priori considered according to the expected response rate and incidence.~   "
78111|NCT02034968|"~     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is~     advantageous for advanced esophageal cancer patients in combination with chemotherapy or~     radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with~     greater efficacy,and with greater concentration in tumor tissue compared with normal~     tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of~     nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal~     carcinoma.~   "
78112|NCT02034955|"~     This study will ultimately aim to evaluate the side effects of treatment by asking 20~     subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan~     adapted after the first week of treatment to account for changes in the target shape. These~     patients will be asked to complete toxicity scores and a quality of life questionnaire at~     the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of~     radiotherapy. These results will be used to determine the feasibility of the proposed~     approach, and obtain early estimates of improvements in uncertainty margin requirements for~     this population of patients.~   "
78113|NCT02034942|"~     Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and~     strength. This can attribute to prolonged admission, prolonged mechanical ventilation,~     increased mortality and might have a negative impact on the physical function, degree of~     independence and quality of life. The pathophysiological background for the loss of muscle~     mass as well as possible effective treatment is still not well established. In the~     NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily~     wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never~     been assessed whether non-sedation reduces the loss of muscle mass and strength.~      Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on~     physical function after discharge from ICU.~      Hypothesis: that non-sedation during ventilator-treatment will improve the physical function~     after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.~   "
78114|NCT02034929|"~     The EndoCuff is novel flexible cuff that can be attached to the distal tip of the~     colonoscope and helps to flatten large mucosal folds during withdrawal.~      The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection~     rate during colonoscopy.~      The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp~     detection.~   "
78115|NCT02034916|"~     The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy~     of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic~     breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be~     assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:~        -  Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen~          for metastatic disease with disease progression > 8 weeks following the last dose of~          platinum; or~        -  Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic~          disease and who have had no prior platinum therapy for metastatic disease~   "
78116|NCT02034903|"~     The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been~     shown to vary greatly, and is influenced by individual provider practice. The clinical~     effect of varying milk temperatures on preterm infant feeding tolerance has not been well~     studied. The purpose of this study is to examine the effect of warming method, water bath~     versus commercial warmer and its impact on feeding tolerance. Sample population will include~     eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care~     Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the~     study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned~     to a control (water bath) or experimental (commercial warmer) group using a randomized~     sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken~     and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric~     residual volume and length of time required to achieve full feeds. Based upon the available~     evidence, the study investigators hypothesize that warming feeds to a consistent temperature~     range using commercially available milk warmer will improve feeding tolerance and decrease~     time to full feedings in preterm infants.~   "
78117|NCT02034890|"~     Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt~     to reduce the incidence of urinary tract infections in patients after orthotopic neobladder~     reconstruction.~   "
78118|NCT02034877|"~     This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65~     years of age and in Indian children 6 to 17 years of age.~   "
78119|NCT02034864|"~     The purpose of this study is to determine whether a standardised osteopathic manipulative~     treatment is more effective on 3 months functional recovery than a placebo of osteopathic~     manipulative treatment, in sub-acute and chronic low back pain less than 1 year duration.~   "
78130|NCT02034721|"~     Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a~     loss of muscle function. Protein-amino acid supplementation before, during, and following~     damaging resistance exercise may reduce muscle damage and accelerate recovery. This study~     will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo)~     before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced~     muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of~     muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor~     Sports).~   "
78120|NCT02034851|"~     Hypothesis: Administration of corticoids (dexamethasone) together with the conventional~     antibiotherapy in the acute phase of a febrile urinary tract infection could reduce the risk~     of renal scarring after 6 months of the primo-infection.~      Primary objectives:To evaluate the reduction in incidence of renal scarring after 6 months~     of a acute pyelonephritis between the control group (conventional therapy plus placebo) and~     intervention group (conventional therapy plus dexamethasone.~      Design: Multicentre randomized clinical trial,placebo controled, including children between~     2 months and 14 years with a acute pyelonephritis proven by a acute phase DMSA~     (dimethylsuccinic acid ). A total of 180 children in to parallel groups (intervention and~     placebo) will be included.~   "
78121|NCT02034838|"~     This is an open-label, single group study to determine the pharmacokinetic profile of~     atazanavir 300 mg daily boosted with ritonavir 100mg daily in HIV-infected patients over a~     period of 9 days.~      Ritonavir and atazanavir are protease inhibitors used to treat HIV. However, ritonavir, when~     used at low doses (up to 100mg) does not have HIV activity, but will enhance (boost) the~     blood concentrations of other drugs like atazanavir.~      Recently, a study showed that taking 50mg of ritonavir administered in an oral solution led~     to similar blood concentrations of atazanavir than when given with 100mg of ritonavir.~     Potential benefits associated with a lower dose of ritonavir may include a reduction of side~     effects such as upset stomach and an improvement in cholesterol level. This study will look~     at the amount of atazanavir into your blood when given with ritonavir in a tablet~     formulation at 50mg or 100mg with standard atazanavir dose (300mg).~   "
78122|NCT02034825|"~     This prospectively designed retrospective clinical utility study will evaluate urologists'~     treatment recommendations before and after reviewing Decipher results for selected patient~     cases.~   "
78123|NCT02034812|"~     This clinical utility study is based on a review of real but de-identified and randomized~     patient cases and aims to evaluate radiation oncologist's treatment recommendations before~     and after reviewing the results provided by the Decipher test. The primary intent is to help~     guide development and design of future clinical utility studies for Decipher.~   "
78124|NCT02034799|"~     The objective of this study is to observe the clinical utility and performance of Bioseal~     when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma~     surgery.~   "
78125|NCT02034786|"~     Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by~     loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of~     normal tissue surface. Millions of plastic and reconstructive surgeries are performed~     annually to repair soft tissue defects due to trauma, tumor resection and congenital~     defects. Surgical options for lipoatrophy, the lipodystrophy type characterized by~     subcutaneous adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat~     graft, Skin flaps and Commercially available fillers.~      Currently, the most commonly filler agent used for the lipodystrophy treatment is~     polymethylmethacrylate, considered permanent and with a history of short- and medium-term~     adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid,~     polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in~     lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient~     solving acne scars and enabling dermis regeneration. Studies in mice showed that the~     combination of pre - adipocytes with a biomaterial is much more effective in tissue~     reconstitution than the injection of adipose tissue only, providing volume and also~     stimulating cell proliferation and differentiation with increased production of~     extracellular matrix.~      This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem~     cells derived from autologous adipose tissue associated with hyaluronic acid.~   "
78126|NCT02034773|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple~     doses of CC-220 in healthy subjects and to evaluate the relative bioavailability of a~     formulated CC-220 capsule~   "
78127|NCT02034760|"~     Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least~     65 years old) are recruited as subjects.~      Upon inclusion, each individual will be randomized into one of the five groups stratified~     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy~     Resistance Training (N=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50),~     Protein Collagen (N=40-50) and Carbohydrate (N=30-35). The individuals randomized into one~     of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be~     blinded to the supplement content.~      Assessments will be performed at Baseline (before intervention start), and after 6 and 12~     months of intervention and again at 18 months (after 6 months of follow up).~      The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12~     months of intervention.~      The primary hypothesis is that by applying the intension-to-treat analysis, the Light~     Intensity Training group will increase quadriceps muscle cross sectional area just as much~     as the Heavy Resistance Training group. The two training groups will gain more muscle mass~     than the Protein Whey group, which will gain more than the Protein Collagen and the~     Carbohydrate groups that will loose quadriceps muscle cross sectional areas.~   "
78128|NCT02034747|"~     This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney~     transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with~     corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized~     into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower~     dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm~     2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.~   "
78129|NCT02034734|"~     The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF)~     pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects.~     Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in~     healthy young Caucasian male subjects and to assess the safety and tolerability of multiple~     doses of ASP3652 in healthy young Caucasian male subjects.~   "
78191|NCT02033928|"~     The purpose of this research study is to describe a patients' fitness before and after~     treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of~     measuring a patient's current quality of health. With surveys, questionnaires and blood~     tests, we hope to create a tool that will give a good picture of patients' ability to~     tolerate treatment. In the future, we hope to devise the best treatment for a patient based~     on their fitness.~   "
78131|NCT02034708|"~     The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as~     compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of~     overall lesion visualization and characterization (off-site assessment).~      270 patients will be randomized between 2 arms defining the sequence of administration of~     the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of~     14 days in between.~      Each patient will, therefore, receive two MRI during his/her participation in the study.~      The two arms consist in :~        -  Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.~        -  Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.~      Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.~      MRI examinations will be evaluated centrally by blinded independent readers for the main~     evaluation criterion.~   "
78132|NCT02034695|"~     Diabetes mellitus (DM) is one of the major cause of morbidity and among the top 10 causes of~     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has~     initiated service improvement through introducing the risk assessment and management~     programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient~     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to~     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the~     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of~     the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital~     will be invited to complete a structured evaluation questionnaire. The data of all patients~     who have enrolled into the RAMP for more than one year will be included in the evaluation on~     the process and outcomes of care.~      One thousand two hundred and forty-eight age and disease matched control patients who have~     not been enrolled into the RAMP programme will be selected for the comparison in the~     outcomes of care. A hundred and thirty participants will be followed up by telephone to~     evaluate the effect of the programme in quality of life (QOL), patient enablement, and~     global rating of change in health condition at baseline and 6 months after enrolment. Data~     on the process of care will be retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the criterion process of care, and achieved the target HbA1c and blood pressure~     levels.~      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC~     criteria will be calculated. The changes in the clinical and patient reported outcomes of~     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample~     t-test. The clinical outcomes between RAMP subjects and control group will be compared by~     independent sample t-test or Chi-square test.~      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     RAMP programme can achieve improvement in QOC for DM patients. The information will be used~     to guide service planning and policy decision making.~   "
78133|NCT02034682|"~     The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced~     electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming~     solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the~     effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using~     near-infrared spectroscopy (NIRS).~   "
78134|NCT02034669|"~     This study is designed to assess the safety and effect of autologous adipose derived stem~     cell (ADSCs) transplantation in acute spinal cord injury patients.~        1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury~          and the complication after ADSCs transplantation.~        2. To evaluate the effect of ADSCs isolation and expansion procedure.~        3. To determine if functional outcome is improved following ADSCs transplantation in acute~          spinal cord injury patient, using pre-transplantation spinal cord function as the~          control.~   "
78135|NCT02034656|"~     The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and~     Ph positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian~     institutes.~   "
78136|NCT02034643|"~     Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase~     tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the~     tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe~     insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and~     double-lumen tube.~   "
78137|NCT02034630|"~     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,~     fludarabine conditioning regimen in genetic rare disease~   "
78138|NCT02034617|"~     When becoming a parent of a preterm infant there is an increased risk of stress. There are a~     number of studies showing that parental stress has a negative impact on their engagement~     with their child. Other studies, on the other hand, show that different intervention~     programs with the aim to strengthen the relationship can decrease parental stress and hence~     affect the parent-infant interaction in a positive way. Structured intervention programs for~     preterm infants have also been successful in improving the infants' cognitive functions.~      The investigators have developed a program with the aim to strengthen the parent-infant~     interaction for late preterm infants. The observational program is called LiMoNid. Our~     hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them~     a deeper understanding of their child. They will hopefully develop more skills on how to~     communicate with their child; to see, interpret, understand and approach the child, which~     can lead to an improved parent-child interaction. Parental stress may also be reduced by~     increased understanding and control. Regarding the child itself, we hypothesize that the~     psychological development will be affected depending on the communication with the caregiver~     and depending on the support it has received in expressing its feelings and needs. The~     emotional regulation should be strengthened by such an intervention.~      The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child~     interaction.~   "
78139|NCT02034604|"~     This study is designed to evaluate efficacy and safety of naftopidil in patient with~     neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.~   "
78140|NCT02034591|"~     The purpose of this study is to assess the bioavailability of Apixaban oral solution~     administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban~     administered as crushed tablet through a nasogastric tube relative to Apixaban solution~     administered orally in healthy subjects.~   "
78141|NCT02034578|"~     The purpose of this study is to assess the bioavailability of Apixaban solution administered~     through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to~     Apixaban solution administered orally in healthy subjects~   "
78142|NCT02034565|"~     The purpose of this study is to assess the oral bioavailability of Apixaban solution~     formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets~     (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.~   "
78601|NCT02028585|"~     This study aimed to investigate the effects of low-fat milk consumption on metabolic~     parameters and biomarkers related to inflammation, oxidative stress, and endothelial~     function in Korean adults with metabolic syndrome.~   "
78143|NCT02034552|"~     The primary objective in this study is to evaluate bone scan response at Week 24 based on~     the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223~     dichloride in combination with abiraterone acetate or enzalutamide will be investigated. The~     study will evaluate radiological progression free survival, overall survival, and skeletal~     events. This study will also explore the clinical utility of different imaging modalities~     (whole body quantified technetium-99 bone scan, DW-MRI and NaF PET-CT scan) and will have a~     separate central radiological review for applicable secondary and exploratory imaging~     endpoints. All subjects will be randomized as assigned randomly by the IXRS system in a~     1:1:1 ratio into one of the treatment arms: radium-223 dichloride alone, 50 kBq/kg (55~     kBq/kg after implementation of NIST update) every 4 weeks for up to 6 doses; radium-223~     dichloride, 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6~     doses together with abiraterone acetate 1,000 mg daily and prednisone 5 mg bid; radium-223~     dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6~     doses together with enzalutamide 160 mg daily.The study will consist of screening, treatment~     and follow-up periods. Study will continue until disease progression as determined by~     investigator, or when patient meets criteria for withdrawal from study. Subjects in~     treatment arms with abiraterone/prednisone or enzalutamide will have the option to continue~     taking oral study therapy until the end of the study (2 years from the last dose of~     radium-223 dichloride) if the investigator deems the subject may benefit and there is no~     clinical or radiological progression. Subjects who discontinue all study treatment prior to~     2 years from last radium-223 dichloride treatment will enter active follow-up. During the~     active follow-up period, the subject will have a safety visit at the clinic every 12 weeks~     from the EOT for up to 2 years from the last dose of radium-223 dichloride. Beyond 2 years~     from last radium-223 dichloride treatment,subjects will enter long-term follow-up and will~     be followed via phone contact at intervals to assess for safety (hematological toxicity and~     new primary malignancies) and overall survival. A separate long-term safety follow-up study~     protocol is planned. Once implemented, the study subjects surviving after the end of the~     active follow-up will be transitioned to this separate long-term safety follow-up protocol.~   "
78144|NCT02034539|"~     In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important~     goal which can normally only be achieved after sufficient treatment of the underlying~     ischemia (revascularization either by an operation, e. g. bypass, or a catheter~     intervention). After successful revascularization everything should be done to improve wound~     healing because this regularly takes weeks up to several months. One possibility to speed up~     healing could be treatment with the VADOplex device which delivers an automatic intermittent~     painless compression of the sole of the foot thereby increasing perfusion of the leg. This~     system can be easily operated by patients themselves and at home.~      Our goal is to prove that the VADOPlex system accelerates healing up and improves quality of~     life.~   "
78145|NCT02034526|"~     Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and~     associated with an increased risk of stroke and death. Within the first two years after~     pacemaker implantation almost half of the patients are diagnosed with AF. Studies have~     indicated that an increased amount of stimulation from the pacemaker in the atria is~     associated with an increased amount of AF.~      The aim of the present study is to test the hypothesis that a reduction of stimulation from~     the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.~   "
78146|NCT02034513|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine~     (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1~     diabetes.~   "
78147|NCT02034500|"~     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of~     a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at~     different dosages by different routes (intradermally, intranasally or intramuscularly) in~     healthy adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB~     vaccine is evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an~     aluminum hydroxide suspension having the same concentration as study vaccine formulations. A~     total of 52 eligible subjects will be assigned to one of three sequential cohorts as~     follows:~      Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN~     and 5 μg IM Within each cohort, in an observer-blind fashion, subjects will be randomized to~     receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen~     concentrations) or GAHB placebo. Specifically for IN and ID administration routes, a Data~     Safety Monitoring Board will be in place to receive a summary of all safety data obtained~     during one week follow-up post-first vaccination with the lower dose. Based on evaluation of~     the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether~     the next cohort should be vaccinated with higher antigen concentration or not.~      Expected duration of the study for an individual subject is 9 months. Each subject will be~     followed-up for 6 months after the 3rd vaccination~   "
78148|NCT02034487|"~     To evaluate the phenotype and biochemical characteristics of boys referred for delayed~     puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate~     the diagnostic criteria and the effect of testosterone treatment.~   "
78149|NCT02034474|"~     Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for~     residual positive, negative, and cognitive symptoms in schizophrenia. The primary study~     hypothesis is that individuals receiving tocilizumab will show greater improvements in their~     PANSS total scores than those taking placebo.~   "
78150|NCT02034461|"~     The investigators will study basic physiology of human peripheral nerves using high-count~     microelectrode arrays implanted into peripheral nerves of patients with limb amputations or~     peripheral nerve injury. These microelectrodes will be custom-made and are not available for~     commercial distribution. The investigators hypothesize that recording neural signals from a~     large number of microelectrodes will provide selective motor information in high enough~     numbers to allow control over future artificial devices with many moving parts, i.e.~     artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These~     studies will also investigate to what extent microstimulation of nerve fibers can provide~     sensory feedback from a prosthetic limb.~      The investigators will also conduct up to three acute surgeries where a Utah slanted~     Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb~     amputations. These acute implantations will provide Dr. Hutchinson with human surgical~     experience in implanting USEAs and evaluating the containment system we will be using to~     immobilize the implanted USEA in the nerve.~   "
78151|NCT02034448|"~     An observational registry to monitor the outcome of CRRT in adults with acute kidney injury.~   "
78152|NCT02034435|"~     Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone~     system impairs glycemic control via effects on insulin sensitivity and insulin secretion.~      Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone~     system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor~     dependent mechanism.~   "
78940|NCT02024152|"~     This study is to investigate the pharmacokinetics (PK) together with the safety and~     tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in~     comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in~     healthy male and female volunteers after a single dose administration.~   "
78153|NCT02034422|"~     Hypertension affects 37% of the Veteran population, making it the most common medical~     condition treated by the VA Health Care System. Physical activity is the first line of~     defense in the treatment and management of hypertension. However, individuals with~     hypertension have impaired muscle blood flow and exhibit exaggerated increases in blood~     pressure during exercise (exercise pressor reflex or EPR) leading to exercise intolerance~     and increased risk of stroke and heart attack. The cause of these impairments is not known,~     but it is highly likely that free radical production and the subsequent increase in~     oxidative stress plays a significant role. Two aims are proposed; Aim 1 will identify the~     physiological consequences of elevated oxidative stress in hypertension, and Aim 2 will~     utilize an antioxidant treatment to ameliorate the effects of an exaggerated EPR allowing~     the safe performance of a clinical exercise rehabilitation program which will then, itself,~     attenuate the EPR and reduce hypertension.~   "
78154|NCT02034409|"~     The purpose of this exploratory trial is to investigate whether PLIUS is potentially~     effective as a disease and symptom modifying intervention in patients with early knee OA.~   "
78155|NCT02034396|"~     Currently, there is no standard approach for the treatment of patients with venous stasis~     ulcers, and no means of accounting for the genetic factors that may contribute to a~     patient's response to different therapeutic interventions. In order to determine whether, or~     to what extent, genetic profiling of venous stasis ulcers can stratify patients according to~     their potential for disease progression or healing, and guide preventive strategies and~     levels of therapeutic interventions, the study will involve retrospective genetic profiling~     of patients with a healed or persistent venous stasis ulcer as a means of determining the~     efficacy of current therapies, and to establish a future prospective evaluation of treatment~     algorithms based on genetic phenotype and variation. Results obtained from the 2~     aforementioned groups of participants will be compared with those of a control group of~     participants who have no history of venous ulcer nor peripheral vascular disease.~   "
78156|NCT02034383|"~     The objective of this study is to measure the effect of processing (roasting, slicing, or~     grinding) on the energy value of almonds in the human diet and study molecular mechanisms~     that may help explain the beneficial health effects of almonds.~   "
78157|NCT02034370|"~     Obstructive Sleep Apnea (OSA) is when a person stops breathing repeatedly during sleep.~     Breathing stops because the airway collapses and prevents air from getting into the~     lungs.This airway closure results in a decrease in the amount of oxygen that is in the~     blood. Anesthetics given during surgery are known to increase the tendency for a patient's~     airway to close immediately after surgery in the recovery room and to reduce the amount of~     oxygen in a patient's blood immediately after surgery. These two factors combined could have~     a profound effect on a patient's well being after surgery.~      Recent advances in general anesthesia, pain medications, and surgical techniques have made~     outpatient surgery more common. Due to the increase in outpatient surgeries, pain management~     techniques that will work efficiently and for longer periods of time are necessary. One of~     these techniques is a nerve block, which coats the nerve with a numbing medication and~     blocks all pain from that area. Nerve blocks are routinely used along with general~     anesthesia for outpatient surgeries and help reduce or eliminate the need for IV or oral~     pain medicine after the surgery. Nerve blocks can provide good pain relief with early~     recovery and fewer side effects (nausea, vomiting, etc.) related to narcotic pain medicines.~      Unfortunately, there are no studies that look at the effect of anesthesia and nerve blocks~     on breathing patterns and oxygen saturation levels after discharge from outpatient surgery.~     We therefore propose to study the changes in lung function tests and blood oxygen levels~     after a nerve block and general anesthesia for outpatient shoulder surgery. We would like to~     conduct a home sleep study including measuring oxygen levels while subjects are sleeping,~     before, during and after surgery, and test lung function both before and after surgery to~     see if there are any differences.~      We will recruit 10 subjects with eligibility based on clinically indicated shoulder surgery~     and a nerve block. The study will be non-interventional during surgery.~      It is possible that future screening for out-patient shoulder surgery includes preoperative~     overnight oxygen saturation measurement to identify patients at high-risk of changes in~     oxygen levels. These patients may benefit from hospital admission after surgery for close~     observation. Thus, this study could have significant implications for patient safety and~     resource utilization.~   "
78158|NCT02034357|"~     The purpose of this study is to determine the impact of sleep and breathing problems during~     sleep on memory, attention, and general well being (quality of life) in people with~     Parkinson Disease.~   "
78159|NCT02034344|"~     The purpose of this study is to obtain skin, blood, and urine samples from patients with~     active cutaneous lupus lesions and from healthy participants.~   "
78160|NCT02034331|"~     Persons with spinal cord injury (SCI) are at an increased risk for metabolic disorders,~     including that of insulin resistance. As a result of neurological injury, they often have~     impaired mechanisms that regulate blood vessel function below the level of injury. Insulin,~     which facilitates the transport of glucose into muscle cells, is also capable of regulating~     skin blood flow, with insulin resistance reducing perfusion. Although beyond the scope of~     this proposal, the possibility exists that impaired microvascular skin blood flow responses~     due to insulin may further predispose to ischemia of the skin at pressure points of bony~     prominence. This perturbed cutaneous vascular response may be speculated to place persons~     with SCI at a heightened risk for the development and poor healing of pressure ulcers due to~     microvascular dysfunction secondary to neurologic and metabolic disorders.~      In individuals with motor complete SCI:~      Primary Aim: To determine the association between systemic insulin sensitivity (as~     determined by an intravenous glucose tolerance test with insulin administration) and~     insulin-mediated vasodilatation below the neurological level of injury.~      • We hypothesize that individuals with systemic insulin sensitivity compared to those with~     insulin resistance will have greater insulin-mediated vasodilatation and an associated~     proportional increase in cutaneous blood perfusion. Thus, intact and appropriate~     endothelial-mediated regulation by insulin will be operative despite sub-lesional~     neurological impairment in insulin sensitive individuals with SCI. However, because of the~     absence of the SNS-mediated insulin action on the microvasculature (i.e., insulin-mediated~     sympathetic withdrawal), it is being hypothesized that the vasodilatory response to~     iontophoresis with insulin in insulin sensitive subjects with SCI will be less than that~     observed in neurologically intact controls with insulin sensitivity.~      Secondary Aim: To compare peak microvascular perfusion responses to endothelial-dependent~     vasodilatation by iontophoresis with acetylcholine to that with insulin.~      • We hypothesize that the peak blood perfusion responses to iontophoresis with insulin will~     be comparable in magnitude to that of acetylcholine (i.e., maximum vasodilatation) in~     individuals with greater systemic insulin sensitivity. This will be in contrast to~     individuals with systemic insulin resistance who will demonstrate a diminished response to~     iontophoresis with insulin when compared to that of acetylcholine. Because of SNS impairment~     below the neurological level of injury, the peak vasodilatory response observed to these~     interventions will be lower in the group with SCI.~      Tertiary Aim: To determine the peak blood perfusion responses of the supra- and sub-lesional~     microvasculature to iontophoresis with insulin and acetylcholine. The effect of SCI on the~     microvasculature above and below the level of lesion is not known, and our work will~     directly address this question. The application of heat, which causes microvascular~     vasodilatation exclusively through a sympathetic mechanism, will determine the relative~     residual contribution of the SNS innervation, if any, to the observed responses to insulin~     or acetylcholine.~      • We hypothesize that persons with SCI and systemic insulin sensitivity will have comparable~     vasodilatory responses above the neurological level of injury (i.e., in the hands due to~     preservation of SNS activity) to that of the able-bodied control group, but those with SCI~     will have blunted responses below the neurological level of lesion (i.e., leg) due to~     varying degrees of autonomic disruption. Blood perfusion responses to acetylcholine at each~     site (e.g., above or below the level of lesion) will be comparable between groups comprised~     of subjects with either systemic insulin sensitivity or insulin resistance.~   "
78161|NCT02034318|"~     The purpose of this research study is to learn about a possible association between cardiac~     denervation (the breaking down of nerves in the heart) and the development of fatigue in~     Parkinson's disease (PD).~   "
78162|NCT02034305|"~     This study is to determine whether physiologic measures (peak cough flow, measures of~     respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict~     spontaneous cough clearance (as measured by a nuclear medicine study) in children with~     neuromuscular disease. It will also determine whether airway clearance is augmented by high~     frequency chest wall oscillation.~   "
78163|NCT02034292|"~     Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and~     clopidogrel.~   "
78164|NCT02034279|"~     The aim of this study is to evaluate whether albumin administration improves short-term~     survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous~     Bacterial Peritonitis (SBP).~   "
78165|NCT02034266|"~     Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes~     of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3~     supplementation will stop diabetes related changes in cornea nerve structure in patients~     with type 1 diabetes to stop the development of nerve injury associated with future risk of~     neuropathy, and reflect changes in the degree of nerve injury over time. As such, we~     anticipate that patients in the study will maintain Corneal Nerve Fiber Length (CNFL), the~     primary outcome measure.~   "
78177|NCT02034110|"~     This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in~     combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid~     cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell~     tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO)~     Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and~     adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is~     designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with~     oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have~     a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status.~     Only subjects with histologically confirmed advanced disease and no available standard~     treatment options will be eligible for enrollment. Subjects will undergo screening~     assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease~     assessments) prior to the start of treatment to determine their eligibility for enrollment~     in the study.~   "
78166|NCT02034253|"~     The early stages of schizophrenia are associated with significant decreases in social and~     intellectual abilities, with more declines in chronic disease. Studies have identified~     relationships between duration of untreated psychosis (the duration between the onset of~     positive symptoms and treatment) and worse long term outcomes. However, the neurobiology of~     this phenomenon and its implications for response to antipsychotic medications remain poorly~     understood.~      Glutamatergic excess altering brain connectivity might provide an explanation for why those~     with longer duration of untreated psychosis have worse clinical outcomes. The investigators~     propose to use neuroimaging to study 67 first episode psychosis subjects before and after~     sixteen weeks of treatment with risperidone, a common antipsychotic. We will measure (1)~     glutamate and (2) structural and functional brain connectivity and test the hypotheses that~     glutamatergic abnormalities are present in first episode patients and that longer duration~     of untreated psychosis is associated with greater connectivity abnormalities that set the~     stage for poor response to treatment. 67 demographic-matched controls will also be recruited~     as a comparison group - healthy controls will not receive antipsychotic medication.~      The investigator's previous studies have made progress in the understanding of abnormalities~     in the glutamate system and brain connectivity in unmedicated patients with schizophrenia~     and modulation of these by antipsychotic medication. Two indices of glutamatergic~     dysfunction have been identified. While antipsychotic medications appear to modulate~     glutamate, the disturbance in the relationship between metabolites is not restored with~     treatment. In addition, the investigators found that both structural and functional~     connectivity abnormalities in unmedicated patients with schizophrenia predict patients'~     response to treatment.~      To the investigator's knowledge, no other group has performed a study that uses a~     combination of complementary neuroimaging techniques that will allow generating a broad~     characterization of glutamatergic function and brain connectivity in first episode psychosis~     and change with treatment. The results of the proposed studies could suggest a mechanism by~     which the duration of untreated psychosis is associated with poor treatment response which~     might lead to new interventions to target the illness.~   "
78167|NCT02034240|"~     Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore~     organ affection. Temporary or permanent kidney failure is a common complication in these~     patients. Today's golden standard for kidney failure detection is creatinine levels rising~     and / or oliguria. The investigators hypothesize that an even more sensitive biomarker;~     neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before~     creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in~     these patient to predict kidney injury, but the time factor for sampling optimally is not~     known. In this pilot study the investigators sample the urine at admission within the first~     hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency~     setting.~   "
78168|NCT02034227|"~     The purpose of this study is to determine if the experimental drug, SG2000 is safe and~     tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and~     acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who~     are not candidates for other types of standard therapy.~   "
78169|NCT02034214|"~     The SHAZ! study was a randomized trial that compared a package of life skills education,~     reproductive health care services, and economic livelihood development to a control package~     of life skills education and reproductive health care services alone. SHAZ! enrolled young~     women 16 to 19 years old who had been orphaned and who were currently out of school and not~     infected with HIV. Individuals participated in the project for up to two years.~   "
78170|NCT02034201|"~     Methamphetamine dependence is a serious public health problem, with methamphetamine abusers~     being at risk for significant morbidity and mortality, including HIV. To date, no medication~     or psychotherapeutic strategy has shown robust, long-term efficacy in treating this~     disorder. This clinical trial will examine whether lisdexamfetamine shows promise in~     alleviating withdrawal symptoms and preventing relapse relative to placebo in~     recently-abstinent methamphetamine dependent individuals. Findings of this study will not~     only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but~     also inform future medication development strategies for improving treatment for drug~     dependence disorders. Discovering efficacious limited risk interventions that show more~     robust, longer-term outcomes would be beneficial both to the individual and society.~   "
78171|NCT02034188|"~     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once~     per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS)~     patients.~   "
78172|NCT02034175|"~     The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for~     diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology~     in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes~     respiration (CSR).~   "
78173|NCT02034162|"~     The purpose of this study is to evaluate the efficacy and safety of mebendazole compared~     with placebo in pediatric participants with Helminth infections.~   "
78174|NCT02034149|"~     This study is being implemented for 3 aims. The first has been to conduct a systematic~     literatures review on CKD intervention models and their effectiveness. Findings have been~     adopted in our intervention program. The second purpose is to establish a practical~     management model or an intervention model for CKD patients and high risk population with the~     18-month of follow-up.In the third year, we will use social perspective point to evaluate~     the costs and the benefits of intervention.~   "
78175|NCT02034136|"~     Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters~     such as cholesterol, blood pressure and glucose.~      Randomized Control Trial.~   "
78176|NCT02034123|"~     GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific~     Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST)~     activity. This is a phase I, open-label, multi-center, non-randomized, 2-part first time in~     human (FTIH) study for GSK2879552. Part 1 is a dose escalation phase to determine the~     recommended phase 2 dose (RP2D) for GSK2879552 based on the safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) profiles observed after oral administration~     of GSK2879552. Any dose level(s) may be expanded up to 12 subjects in order to collect~     additional data on PK and PD.The safety and PK/PD data will be reviewed prior to the dose~     decision, and the dose escalation will be guided by the Neuenschwander -continuous~     reassessment method (N-CRM). Built-in safety constraints are in place to prevent exposing~     subjects to undue risk of toxicity. Once RP2D is identified, an expansion cohort (Part 2) of~     up to 30 subjects will be enrolled to further evaluate the clinical activity and~     tolerability of GSK2879552 in subjects with relapsed/refractory SCLC.~   "
78178|NCT02034097|"~     Foretinib (GSK1363089) is an investigational, oral, multikinase inhibitor involved in~     invasion, migration, and angiogenesis. This is a phase II, open label, uncontrolled,~     parallel, multi-cohort, multicenter 2-stage study to assess the safety and efficacy of~     foretinib and erlotinib combination therapy and foretinib monotherapy in genomic~     subpopulations of Non-Small-Cell Lung Cancer (NSCLC) subjects.~   "
85159|NCT01942759|"~     The purpose of this study is to determine findings of positron emission tomography and~     diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast~     cancer and compare of two imaging modality in these patients.~   "
78179|NCT02034084|"~     Previous studies have shown that the transradial cardiac catheterization has decreased not~     only bleeding complications related to the access site and procedural discomfort but also~     morbidity and hospitalization as compared to transfemoral approach. At present, the right~     radial approach (RRA) is the first choice routinely for coronary angiography and~     interventions in daily clinical practice despite more marked subclavian artery tortuosity~     than left radial approach (LRA). Although LRA has been thought to be more direct access to~     the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and~     cerebrovascular complications compared with RRA, the application of LRA for coronary~     intervention is still low. Moreover, several studies have also obtained conflicting results~     showing no difference in procedural success rate compared LRA and RRA using Judkins~     catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and~     feasibility for coronary angiography and interventions in real world practice and few data~     of randomized control trial are available.~      The aim of this study was to randomly investigate and compare the safety and feasibility of~     LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.~      The investigators will enroll consecutively for 2 years all patients undergoing coronary~     diagnostic procedures through trans radial approach.~      The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy~     time, dose of radiation including cumulative air kerma and dose area product, contrast~     volume and the incidence of vascular complications.~   "
78180|NCT02034071|"~     • This is a single-center, open-label, single-arm study with a double-blind,~     placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose~     of about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about~     2.4 mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses~     are equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered~     dose will be as close to the mg/kg dosing as can be achieved by the available dose strengths~     of DCCR. Patients will be up-titrated at each visit at the discretion of the investigator.~     All patients will be continued in the double-blind, placebo-controlled, randomized~     withdrawal extension. Any patient who showed an increase in resting energy expenditure~     and/or a reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated~     a responder, whereas all others will be designated non-responders. Responders will be~     randomized in a 1:1 ratio either to continue on active treatment at the dose they were~     treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks.~     Non-responders will continue open label treatment during the extension.~   "
78181|NCT02034058|"~     The primary objective of this study is to evaluate the rate of stroke and/or death in~     patients treated with the Wingspan Stent System, according to the Indications for Use,~     within 72 hours post procedure.~   "
78182|NCT02034045|"~     Initiatives aimed at reducing Emergency Department (ED) wait times and improved community~     health initiatives are major priorities in Canada. Three of the most common chronic diseases~     worldwide are Diabetes Mellitus (DM), Congestive Heart Failure (CHF) and Chronic Obstructive~     Pulmonary Disease (COPD). These diseases are on the rise and currently cost the Canadian~     health care system billions of dollars every year including the cost of hospitalizations and~     ED visits. The existing health care system does not have the resources and manpower to~     effectively care for these patients in the future.~      Paramedics are currently employed to provide Emergency Medical Services in remote, rural and~     urban settings in Canada.~      They are highly trained health care practitioners that are mobile in the community and~     currently work in a physician medically delegated act model and therefore are positioned to~     take on new collaborative roles to deliver patient care in the community setting. Increased~     community paramedic care could decrease the utilization of the health care system resources~     for patients with chronic disease. Using a randomized control trial design we will attempt~     to answer the question of whether whether non-emergency community paramedics conducting home~     visits to undertake assessments and evidence-based treatments of patients in partnership~     with family doctors will decrease the rate of patient hospitalization.~   "
78183|NCT02034032|"~     The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to~     Exercise Therapy at three months. Historical comparison will be made to Total Knee~     Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.~   "
78184|NCT02034019|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical~     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular~     lens implantation.~   "
78185|NCT02034006|"~     The primary objective of the study is to investigate current criteria driving re-treatment~     in patients affected by CNV secondary to PM and experiencing a relapse of the disease after~     the first administration of ranibizumab.~   "
78186|NCT02033993|"~     The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel~     compared to paclitaxel to treat this disease.~      This research is being done because currently there is no effective treatment for urothelial~     cancer that has progressed after prior chemotherapy.~   "
78187|NCT02033980|"~     Recently, a new category classification (NICE classification) using non-magnified NBI has~     been proposed. We design this multicenter study to evaluate the reliability and validity of~     the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both~     image and real-time process.~   "
78188|NCT02033967|"~     Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This~     procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke~     volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload.~     The investigators try to evaluate the relationship between CVP and SVV during CVP-guided~     vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced~     hypovolemia using the SVV calculated from the validation study will be tested (feasibility~     study).~   "
78189|NCT02033954|"~     To collect confirmatory data in support of the safety and performance of the ArtVentive~     Medical Group Endoluminal Occlusion System.~   "
78190|NCT02033941|"~     Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia.~     Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD~     subjects. As secondary measures, we will also provide the essential human data to guide the~     design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration~     in AD patients.~   "
78192|NCT02033915|"~     Suicide attempters or people with self-harm have a high percentage in seeking medical~     services before and after their suicidal or self-harm behaviour compared to general~     population. Studies revealed that apart from psychiatric services, they were more likely to~     seek help from doctors of various units (e.g. emergency departments, general medicine,~     medical-surgical units) across different healthcare systems (i.e. hospitals or district~     clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or~     non-psychiatric units. People with self-harm experienced poor communication with healthcare~     personnel, and they perceived staff's lacking knowledge about suicide as serious problems.~     In Taiwan it was also found that emergency nurses and general practitioners were in need of~     improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the~     point that nurses are the healthcare personnel that spend the most time with in-patients~     compared to others in the hospital, suicide risk assessment training may enhance nurses'~     attitudes and ability of risk awareness and assessment towards people with self-harm, which~     may in turn significantly increase the identification rate of the high risk group for~     suicide. Currently there is a lack of suicide training program as a reference for nursing~     education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability~     among clinical nurses through interactive discussion groups. Using quasi-experimental design~     with randomized cluster sampling strategy, a case vignettes will be used for suicide risk~     assessment together with other measurements regarding suicide knowledge and attitudes for~     both experiment and control groups before and after the training course.~   "
78193|NCT02033902|"~     The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel)~     as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.~   "
78194|NCT02033889|"~     This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes~     mellitus and inadequate glycemic control on metformin monotherapy. The primary study~     hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c)~     for ertugliflozin is greater than that for placebo.~   "
78195|NCT02033876|"~     This study will evaluate whether bile acids are able to increase insulin sensitivity and~     enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance~     glycemic control. These observations will provide the preliminary data for proposing future~     therapeutic as well as further mechanistic studies of the role of bile acids in the control~     of glycemia in T2DM.~   "
78196|NCT02033863|"~     To collect confirmatory data in support of the safety and performance of the ArtVentive~     Medical Group Endoluminal Occlusion System.~   "
78197|NCT02033850|"~     Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel~     disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment~     (VMCI) defines a transitional state between normal ageing and VaD. Attentional deficits are~     a common finding in patients affected by VMCI or subcortical VaD. At present, no drug~     treatment is available to prevent vascular dementia in patients with VMCI or to improve~     cognitive performances of this large group of patients. Cognitive rehabilitation is directed~     to achieve functional changes by reinforcing, strengthening, or reestablishing previously~     learned patterns of behavior, or establishing new patterns of cognitive activity or~     compensatory mechanisms.~      A hierarchical model of attention has been used to build the Attention Process Training-II~     (APT-II) programme.~      The APT-II programme effectiveness have been demonstrated in traumatic brain injury and~     post-stroke rehabilitation, but there is an increasing interest in the study of cognitive~     rehabilitation in pathological processes that evolve over time, such as chronic~     cerebrovascular diseases (CVD).~      Aims: The purpose of this study is to investigate whether the APT-II programme could be a~     useful tool in the rehabilitation of attention in individuals affected by VMCI with SVD, and~     if so, whether the improvement in performance is generalized to functionality in daily~     activities and quality of life.~      Main Expected Results and Impact: Considering that the APT-II contains specific exercises to~     facilitate generalization to daily life, the skills that are learned by each patient during~     the rehabilitation programme should be generalized to daily activities.~      Furthermore, the improvement of cognitive skills should also improve patient's overall~     quality of life because these learned skills are applicable to real-life situations. The~     main expected results are: 1) an impact of APT-II on disability, everyday cognition, quality~     of life, and performance on attention tests at short and long term after rehabilitation~     programme ending as compared with standard care; 2) a reduction of the risk of transition to~     dementia at 1 year follow-up as compared with control group.~   "
78198|NCT02033837|"~     The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical~     indications and appropriateness of cardiac CT has not been adequately investigated. The~     purpose of the survey is to assess the distribution of appropriateness ratings and test~     outcomes of cardiac CT with second-generation ADCT.~   "
78199|NCT02033824|"~     The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue~     formation in craniectomy patients as well as facilitating reoperation and repair.~     Specifically this study compares craniectomy without dHACM application to craniectomy with~     placement of dHACM between the galea and dura over dural suture line and/or exposed~     parenchyma.~   "
78200|NCT02033811|"~     Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic~     alternative to surgical valve repair (PMVR) in high risk patients.~      The aim of this registry is to collect prospectively and systematically clinical research~     data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end~     observational study to assess the characteristics and outcomes patients with severe mitral~     regurgitation undergoing PMVR.~   "
78201|NCT02033798|"~     The purpose of this study is to determine whether medical treatment for bladder outlet~     obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.~   "
78202|NCT02033785|"~     Holmium laser prostatectomy will enhance voiding function.~      Holmium laser prostatectomy will enhance sleep quality.~      Holmium laser prostatectomy will enhance renal function.~      Holmium laser prostatectomy will enhance erectile function.~      Holmium laser prostatectomy will enhance the health-related quality of life.~   "
78203|NCT02033772|"~     The study is primarily a descriptive study examining the physiological, ventilatory,~     surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic~     surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2~     (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.~   "
78223|NCT02033512|"~     There is a dilemma and a permanent debate about side effects on drugs administered orally.~     The first-pass metabolism is related with many side effects, since the metabolites of these~     compounds affect the course of human physiology. Conventional hormone therapy by oral route~     has been used for relieving menopausal symptoms. Transdermal estrogens have not been used~     extensively in Brazilian women with menopausal symptomatology, however; recently a previous~     long term study has indicated no increased risk breast cancer or vasomotor disorders in~     menopausal women, using transdermal HRT.~   "
78204|NCT02033759|"~     We propose to study the impact of BIA screening on anxiety and primary prevention strategies~     for lymphedema development among patients with recent surgery for breast cancer. Currently,~     professional societies recommend scheduled follow-up visits to screen for lymphedema after~     recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified~     lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk~     reduction strategies, measurement of the affected limb with a tape measure, and physical~     inspection for physical changes consistent with lymphedema. In the proposed study, patients~     will be randomly assigned to the addition of BIA screening vs. usual care. At each screening~     visit, all patients will be assessed for their current lymphedema risk behaviors, as~     outlined by the National Lymphedema Network (7). To evaluate anxiety levels, all patients~     will be asked to fill out the Beck Anxiety Inventory, a validated screening tool used in~     prior studies of patients with breast cancer (8,9). This questionnaire will be administered~     at each follow-up lymphedema screening visit, and the baseline will be administered at the~     preoperative visit. For patients randomly assigned to BIA screening, this involves the~     placement of adhesive electrodes on the each wrist and an ankle, followed by connection of~     the electrodes to the BIA machine, which then uses a painless electrical impulse to measure~     impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2~     upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk~     behaviors and anxiety levels between those patients with vs. without BIA screening.~   "
78205|NCT02033746|"~     Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on~     buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6~     weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality~     of life and decrease drug cravings ultimately while facing everyday life stressors.~   "
78206|NCT02033733|"~     After successful resuscitation from cardiac arrest, cooling the whole body is a well~     established treatment that improves the chances of the brain recovering. This however, has~     to be done within a certain time-frame from the arrest. The purpose of this study is to~     explore the best way of dosing the muscle relaxing medications that are given during the~     cooling process.~      Hypothesis: In the context of our institutional therapeutic hypothermia protocol,~     cisatracurium infusions lead to faster drops in core temperature when compared to~     cisatracurium prn boluses alone.~   "
78207|NCT02033720|"~     After successful resuscitation from certain types of cardiac arrest, total body cooling is~     now a well established treatment that improves the chances of the brain recovering. This~     however, has only been definitively proven after a certain type of cardiac arrest that is~     ventricular fibrillation / ventricular tachycardia. The purpose of this study is to~     explore if total body cooling is beneficial for patients recovering from another type of~     cardiac arrest that is pulseless electrical activity.~      HYPOTHESIS:~      Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological~     outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison~     to asystole.~   "
78208|NCT02033707|"~     This non-treatment study will investigate the effects on mood and performance caused by~     hallucinogens and other psychoactive compounds.~   "
78209|NCT02033694|"~     The purpose of this study is to enhance medical knowledge of the causes of future coronary~     problems. Many studies in patients who have already experienced a coronary problem point to~     the danger associated with plaques that are rich in cholesterol. This study determines if~     the near-infrared method of detection of these fatty plaques can predict future events. If~     dangerous plaques can be identified, there are many treatments already available that could~     be tested for their ability to prevent coronary events.~   "
78210|NCT02033681|"~     The aim of this study is to know the characteristic of one-per-mil tumescent solution in~     regards of the optimal time delay to achieve optimal visualization of operation field in~     hand and digit surgery.~      Hypothesis:~        1. Epinephine in one-per-mil concentration by tumescent injection technique will provide~          faster decrease in oxygen saturation compared to normal saline solution injected by~          tumescent technique.~        2. Epinephrine in one-per-mil concentration by tumescent injection technique will~          provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time~          delay.~        3. Epinephine in one-per-mil concentration by tumescent injection technique causes no~          finger necrosis as normal saline solution injected by tumescent technique.~   "
78211|NCT02033668|"~     This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous~     (SQ) administration for subsequent studies with GSK933776 by characterizing the safety,~     tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM~     and SQ administration in healthy volunteers. Such alternate routes of administration may~     provide more options in the selection of an efficacious dose for subsequent development in~     patients with geographic atrophy. There will be four treatment arms in the study and~     participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The~     planned number of evaluable participants for this study is 24 with 6 participants completing~     all critical assessments in each of the four treatment arms. The total duration of~     participation from screening to follow-up for Treatment Arms A, B and D (single dose of~     GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat~     dose of GSK933776) will be approximately 134 days.~   "
78212|NCT02033655|"~     The purpose of the trial is to assess the effects of combining regular, generous intakes of~     high quality protein (primarily from lean pork and other animal source proteins) with~     calorie restriction on functional status and lean muscle mass in frail, obese, women who~     participate in a 6 month intervention and 9 month intervention.~   "
78230|NCT02033421|"~     The recommended length of antibiotic treatment to patients with infective endocarditis is~     4-6 weeks. All patients receive the same dosis except for those with renal impairment who~     receive a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the~     minimal inhibitory concentration (MIC) for at least 50% of the time in a dosing interval~     maximize bactericidal activity. To estimate the time for which the antibiotic concentration~     is above the MIC (T>MIC) and to see if there might be a relationship between the~     concentration of antibiotics and possible side-effects, toxicity and treatment failure, all~     patients admitted with infective endocarditis will be followed and have two blood tests~     withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.~   "
78213|NCT02033642|"~     The first purpose of this randomized controlled trial is to test the efficacy of a~     24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a delayed~     treatment group which later receives the same FBBI - that targets weight loss in~     adolescents/young adults with intellectual disability aged 15-22 years. The second purpose~     of this randomized controlled trial is to examine the efficacy of a 12-session, 6-month~     Maintenance intervention that targets maintenance of weight loss in the same population of~     adolescents/young adults with intellectual disability. The Maintenance condition follows the~     completion of each FBBI group and involves a re-randomization to either the Maintenance~     intervention or no further intervention. Outcome measures include Body Mass Index (BMI),~     waist circumference, physical activity/sedentary behavior (measured via accelerometry),~     dietary patterns (3-Day Food Records), self-efficacy and psychosocial characteristics~     (Adolescent Depression and Anxiety Scale). Hypotheses are that (1) participants in the FBBI~     condition will lose more weight (reduced BMI) than participants in the delayed treatment~     condition, and that (2) participants in the Maintenance condition will maintain weight lost~     (reductions in BMI) or experience less weight regain, as compared with participants who~     receive no further intervention following FBBI.~   "
78214|NCT02033629|"~     The development of target effect-site controlled concentrations (TCI) of remifentanil have~     gained increasing acceptance during cardiac surgery as regarding the resulting of~     hemodynamic stability and early extubation. The use of low-dose opioid technique has been~     progressively used nowadays because of its ceiling effect to attenuate cardiovascular~     responses to noxious stimuli. We hypothesize that the use of low target remifentanil effect~     site concentrations may provide comparable shorter times to tracheal extubation and~     hemodynamic stability to the use of high remifentanil Ce during target-controlled propofol~     anesthesia for cardiac surgery.~   "
78215|NCT02033616|"~     This is a double-blind study in which approximately 99 study patients will be randomized in~     a 2:1 ratio to receive either ovapuldencel-T (autologous dendritic cells loaded with~     irradiated autologous tumor cells in GM-CSF) or MC (autologous PBMC in GM-CSF). Patients~     eligible for treatment will be those (1) who have undergone debulking surgery, (2) for whom~     a cell line has been established, (3) who have undergone leukapheresis, (4) are scheduled~     for primary adjuvant chemotherapy, and (5) have an ECOG performance grade of 0 or 1.~      The primary endpoint of this trial is death from any cause with the metric of overall~     survival (OS) from the date of randomization. Progression-free survival (PFS) will be a~     secondary endpoint and will be calculated as the time from the date of randomization for~     treatment until subjective tumor progression or death. Progression will be subjectively~     defined by the treating physician, and is expected to be based on tumor marker levels (e.g.~     CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of~     debulking surgery.~      Patients will be stratified into (1) platinum-resistant, based on progression during~     adjuvant chemotherapy or detectable disease at the conclusion of adjuvant therapy or (2)~     platinum-sensitive, with no evidence of disease (NED) at the conclusion of adjuvant therapy~     (per elevated blood CA-125 and/or tumor markers and/or detection of disease by physical~     examination or imaging).~      Summary of Stratification and Treatment Plan Platinum Sensitive Platinum Resistant~     Ovapuldencel-T Arm Ovapuldencel-T + Paclitaxel Ovapuldencel-T+ Secondary Adjuvant therapy MC~     Arm Mononuclear cells + Paclitaxel Mononuclear cells + Secondary Adjuvant therapy~   "
78216|NCT02033603|"~     Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of~     the knee which is increasingly performed as the population ages. It is a painful surgery and~     one of the methods to reduce post-operative pain is performing a regional anaesthesia~     technique. The current practice is to perform a femoral nerve block (FNB) which blocks the~     nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective~     analgesia. However, it also results in weakness of the quadriceps and may result in falls~     post-operatively.~      Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is~     hypothesised to provide as effective analgesia, with less quadriceps weakness compared to~     FNB, hence potentially reducing the risk of falls post-operatively.~      Investigators aim to study if the analgesia provided by ACB is as good as FNB while~     preserving quadriceps strength.~   "
78217|NCT02033590|"~     The objective of this study is to prospectively observe clinical and economic outcomes with~     the use of SERI® in direct-to-implant breast reconstruction.~   "
78218|NCT02033577|"~     Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass~     operation) gives better results on body weight in the superobese. We do not yet know whether~     it is beneficial to exclude more of the proximal small bowel or more of the distal. Side~     effects of bypassing can also be different.~      Study aims at clarifying possible differences in effects and side-effects of these two~     surgical-technical variations.~   "
78219|NCT02033564|"~     The purpose in this study is to determine whether there is a difference in the incidence of~     postoperative sore throat when using the GlideScope™ versus a traditional intubation blade~     involving patients that are not anticipated to have a difficult airway.~   "
78220|NCT02033551|"~     This is an extension study to evaluate the safety of Veliparib monotherapy or in combination~     with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI)~     in subjects with solid tumors.~   "
78221|NCT02033538|"~     Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and~     safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in~     neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial~     was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound~     paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell~     carcinoma.~   "
78222|NCT02033525|"~     The present proposal has the objective to assess whether the addition of autologous ex vivo~     expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury~     rehabilitation program is contributing in creating the proper healing environment for the~     meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of~     the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The~     conduction of this clinical trial will, in addition of having the aim of improving the~     patient's quality of life, contribute to consolidate an emerging new type of therapy which~     is still under development.~   "
78224|NCT02033499|"~     For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin,~     decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a~     resource intensive activity without firmly established patient benefits. While SMBG holds~     great promise for sparking favorable behavior change, the potential for no benefit or even~     patient harm must be acknowledged. Possible negative effects on patient quality of life must~     be more closely examined along with the speculative benefits of SMBG in non-insulin treated~     T2DM. Among studies examining this issue a general consensus is evolving; while SMBG may or~     may not be useful, its value can only be fully appreciated when the SMBG results are~     provided to patients in a useful manner. The overarching goal of this proposal is to assess~     the impact of three different SMBG testing approaches on patient-centered outcomes in~     patients with non-insulin treated T2DM within the real-world, clinic setting. In this~     pragmatic trial, 450 patients will be randomized to one of the following three SMBG testing~     regimens: 1) no SMBG testing, 2) once daily SMBG testing with standard patient feedback~     consisting of glucose values being immediately reported to the patient through the glucose~     meter, and 3) once daily SMBG testing with enhanced patient feedback consisting of glucose~     values being immediately reported to the patient PLUS automated, tailored feedback~     messaging. The first two arms represent common SMBG testing approaches. The third arm is an~     enhanced, patient-centered approach to SMBG testing. SMBG values will be evaluated at~     routine clinic visits over 52 weeks.~   "
78225|NCT02033486|"~     Screening for breast cancer improves early detection of aggressive cancers and has been~     shown to reduce breast cancer related mortality. Currently, mammography is the most~     effective way of detecting early stage, non palpable breast cancers. However, mammography~     only reveals the breast structure, and cannot say much about the breast physiological state.~     We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly~     technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near~     infrared light and by measuring how such light passes through the breast, images of blood~     volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with~     digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the~     TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved~     sensitivity and specificity compared to DBT alone.~   "
78226|NCT02033473|"~     The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The~     apelin and its receptor, which is named apj, are expressed in many tissues including~     sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart~     tissue.~      Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of~     investigation, demonstrating for the first time in mouse models that apelin exerts a~     glucose-regulating in vivo action. The investigators propose a translational clinical~     research project whose goal is to provide the proof of concept of the favorable influence of~     apelin on insulin sensitivity in humans.~   "
78227|NCT02033460|"~     The purpose of this study is to know which combination of treatments are the most effective~     in patients with non-specific neck pain. Study design: This is a single-blind randomized~     controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years~     old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a~     period of 4 weeks (8 sessions total; 2 per week).~   "
78228|NCT02033447|"~     Men with early prostate cancer face a number of options which lie at the extremes of care.~     On one hand, active surveillance involves monitoring the disease and on the other, immediate~     treatment involves surgery or radiotherapy. The difference between these two strategies in~     terms of reducing the chance of a man dying from his disease is small. Not only is the~     benefit small, surgery or radiotherapy carry significant side-effects. These occur because~     of damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile~     dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).~      The investigators have been working on new forms of treatment that use heat, light or cold~     to destroy tissue and minimise treatment-related harms. The investigators have not yet found~     one that delivers the ideal treatment. The ideal treatment is one that can be done under~     local anaesthetic, can effectively destroy areas of cancer, limit damage to surrounding~     tissues, is repeatable, and adaptable to future discoveries such as molecular targeting of~     cancer cells.~      The investigators think magnetic thermoablation may be able to deliver on these ideal~     attributes. Magnetic thermoablation involves injecting magnetic iron nanoparticles directly~     into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up~     to very high temperatures that kill cells. Magnetic thermoablation does not use x-rays or~     surgical incisions. The investigators have done a lot of the preclinical work already to~     develop this type of treatment. The investigators now need to develop a system that can be~     used to treat prostate cancer. However, before the investigators can do this, they need to~     test whether the magnetic nanoparticles actually stay where they are injected. The~     consequences of them moving to areas that they should not can be serious. First, the~     nanoparticles could move away from the cancer which means the cancer will not be heated~     effectively. Second, the nanoparticles could move to sensitive structures around the~     prostate (back-passage, bladder, sphincter muscle controlling urine flow, nerves controlling~     erections). If this happens, damage of those sensitive structures could occur leading to~     side-effects.~      The investigators propose a study to try and find out what happens to those nanoparticles.~     The study will involve approaching men who are having their prostates removed by radical~     surgery. If these patients agree to participate, the investigators will inject their~     prostate with varying amounts of nanoparticles. The investigators will NOT heat them up. The~     investigators will use special scans and, once they have had their surgery, to look at the~     pathology specimens to see where the nanoparticles have gone. The actual nanoparticles are~     not harmful but the process of injection can carry a small amount of harm. If the~     nanoparticles stay where they are injected, the investigators will then be able to run~     another study in which we treat men who have prostate cancer with magnetic thermoablation.~   "
78229|NCT02033434|"~     The investigators hypothesize that intra-nasal ketamine, for analgesia of patients with~     moderate to severe pain in an alpine setting, will provide a clinically significant~     reduction in pain and provide an effective and feasible alternative to intravenous opioids.~      The investigators wish to know:~        1. Is our study protocol feasible to study INK in a mountain, prehospital care~          environment?~        2. What estimate can be made of recruitment rates?~        3. Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?~        4. Is intra-nasal ketamine an effective and safe method for controlling pain in our study~          population and setting?~        5. Does intranasal ketamine provide a clinically significant reduction in pain or do~          patients require additional IV narcotics for extraction?~        6. Are there any significant changes in vital signs after administration of intra-nasal~          ketamine~        7. Does the use of intra-nasal ketamine reduce time of patient extraction and transport in~          the alpine pre-hospital setting?~        8. Are there any long term sequelae of INK at one week?~   "
78279|NCT02032771|"~     Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of~     3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their~     facial skin appearance.~      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or~     pigmentation by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups~     in at least 50% of the study population.~   "
78280|NCT02032758|"~     The investigators will investigate golfers with visual evidence of an involuntary movement~     while putting before and after treatment with a low dose of propranolol.~   "
78231|NCT02033408|"~     the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut~     microbiome. The results of previous studies on the effectiveness of antibiotics and fecal~     macrobiota transplantation (FMT) are contradicting.~      Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe~     colitis in an addition to standard corticosteroid therapy (UC and isolated UC-like Crohn's~     colitis). The secondary aim is to assess the outcome of FMT in those not responding to five~     days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant~     disease to at least two immunosuppressive medications, may be treated with either~     interventions.~   "
78232|NCT02033395|"~     This observational study follows subjects who have been exposed to a traumatic event and are~     at risk of developing PTSD symptoms. Participants are recruited within six hours of a~     traumatic event, and, starting from the recruitment session, are then examined on six set~     points of time within a period of thirteen months. The examinations include both biological~     studies of cortisol in hair, blood and saliva, and psychological examinations and~     questionaires that assess the development and severity of PTSD symptoms.~      The novel method of sampling hair cortisol allows investigators to retroactively estimate~     the mean levels of blood cortisol during the tree months prior to the sampling.~      The study aims at further illuminating the correlation between cortisol levels both prior~     and following a traumatic event, and the development and severity of PTSD symptoms~   "
78233|NCT02033382|"~     This study will identify and evaluate relevant biomarkers and structural brain imaging for~     understanding potential biological illness related mechanisms in medication-naïve subjects~     with early psychosis before and after initiation of antipsychotic medication~   "
78234|NCT02033369|"~     This study aims to determine whether ventral striatal dopamine release is a mechanism of~     reward motivation in major depression, whether dopamine release is low in depression, and~     whether DA release and reward motivation predict response to dopamine-targeted treatment~     with pramipexole.~   "
78235|NCT02033356|"~     The aim of this prospective dose finding study is to estimate the minimal effective volume~     (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal~     block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use~     an MRI scan to evaluate the main objective and ensure spread to the distal part of the~     adductor canal.~   "
78236|NCT02033343|"~     The purpose of this study is to monitor movement of the prostate during radiotherapy and~     adjust the radiation beam to account for any motion seen. This will increase the radiation~     dose to the prostate and decrease the dose to the rectum and bladder.~   "
78237|NCT02033330|"~     In this study, the bioavailability of a specific orange peel extract is tested. The~     composition and morphology of the test product is altered compared to the generic product,~     which is used as a control. Due to intellectual property issues, more information cannot be~     given at this moment. Also the difference in bioavailability between a capsule and a lozenge~     is tested. The hypothesis is that the bioavailability of the altered extract will be~     improved compared to the control.~   "
78238|NCT02033317|"~     This study assessed the pharmacodynamic effects of patiromer on serum potassium in~     participants on hemodialysis.~   "
78239|NCT02033304|"~     In spite of identical analgesic protocols, parturients suffer different levels of pain~     postoperative lay. In this study we hope to identify factors which influence the perception~     of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.~   "
78240|NCT02033291|"~     Cerebral small vessel disease (cSVD) encompasses all pathological processes that affect the~     small vessels of the brain. On brain-MRI cSVD is characterized by structural brain~     abnormalities such as white matter lesions (WMLs). Clinically, cSVD is related to acute~     syndromes as lacunar stroke but also to more chronic health problems such as cognitive~     decline. Recent literature suggests that a disrupted blood brain barrier (BBB), leading to~     elevated BBB permeability, may play a pivotal role in the aetiology of cSVD and lacunar~     stroke. The BBB is a complex system of neuronal, glial and vascular cells which main~     function is to shield the brain from toxic components and regulate the homeostasis.~     Elucidating the role of the BBB may have far reaching consequences for the treatment of cSVD~     patients and the reduction of recurrence rate of the disease. This could lead to a better~     quality of life among cSVD patients and reduce the economic burden on society. Currently the~     exact contribution and extent of a possibly defective BBB in cSVD remains largely unclear,~     due to the lack of a reliable method to accurately quantify the BBB permeability in cSVD~     patients. As a result, the current treatment consists of treating the cardiovascular risk~     factors, often with poor results.~      Quantification of the BBB permeability provides an objective measure of the integrity of the~     BBB and as such aids the study of the role of the BBB. The aim of this study is to realize a~     clinically applicable MRI-method to quantify the BBB permeability. Moreover, the method can~     be used to study the involvement of BBB disruption in other neuropathologies including~     Alzheimer's disease, vascular dementia, hypertension and diabetes.~      Primary Study Objective:~      To realize a clinically applicable quantification of BBB permeability using DCE-MRI by~     determining the reproducibility of the DCE-MRI method~      Secondary Study Objective:~      To achieve the shortest scan duration without compromising the reliability of the BBB~     permeability quantification.~      Hypotheses:~        1. Using an optimized DCE-MRI method to quantify the BBB permeability, the BBB~          permeability can be reliably determined in cSVD patients.~        2. The scan duration can be shortened without compromising the reliability of the BBB~          permeability quantification.~   "
78241|NCT02033278|"~     Clinical trial phase II-III, double-blind, randomized, controlled with placebo. There is~     sufficient preliminary evidence to consider intracoronary injection of bone marrow~     progenitor cells as a viable, safe and beneficial treatment in patients with dilated~     cardiomyopathy, although the biological mechanism of action of bone marrow cells in the~     myocardium is not known. In this project we propose to investigate comparatively and from a~     biological and clinical point of view the applicability of regenerative therapy with~     autologous bone marrow cells in patients with dilated cardiomyopathy.~   "
78258|NCT02033057|"~     Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or~     neuropathy which difficulties both the process of extubation and the functional recovery.~     The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on~     muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a~     single center, prospective, randomized trial to be held in the ICU of  Universitarian~     hospital La Fe in collaboration with the service of Neurophysiology of the hospital. All~     patients undergoing sedation and mechanical ventilation (with an expected duration longer~     than 48h) and without any of the exclusion criteria detailed in the Methodology section will~     be included in the study. The intervention will consist of a muscular electrostimulation~     with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle~     groups (5 per side) following established protocols, at least 5 days a week. We will~     evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel~     scale and Neurophaty Disability Scale, all clinical events will be collected and~     electrophysiologic, echographic and histologic parameters will be measured. The process of~     extubation will be performed following an established protocol, the duration will be~     collected as the same manner as ICU.~   "
78242|NCT02033265|"~     Axillary brachial plexus block (freezing the nerves in armpit) is commonly performed as a~     primary anesthetic technique for the elbow/ forearm or hand surgery. These nerves are~     identified using ultrasound and nerve stimulator (by stimulating the nerves using a small~     current through the needle). Axillary brachial plexus block has been shown to result in~     better pain relief, less nausea, vomiting and early discharge from hospital. The use of~     these nerve blocks have also shown to decrease the duration of hospital stay, decreased side~     effects of opioids painkillers and better satisfaction scores over the conventional use of~     intravenous and oral pain medications. These beneficial effects are particularly useful for~     patients who are overweight or obese. A study by Hauouz et al published in Anesthesia and~     Analgesia in July 2010 suggests that the success rate of brachial plexus block is lower for~     obese and overweight patients. However, ultrasound guidance was not used for performing~     axillary brachial plexus block in this study. We propose that with usage of ultrasound~     guidance the success rate of brachial plexus block will be similar in obese and non-obese~     patients.~      In this study, we want to compare the success rate of axillary brachial plexus block for~     obese and non-obese patient groups. We would also like to look at performance time,~     complications and patient satisfaction for our study population.~   "
78243|NCT02033252|"~     This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture~     therapy on persistent allergic rhinitis patients complicated with asthma.~   "
78244|NCT02033239|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting~     insulin aspart (FIAsp) in subjects with type 1 diabetes.~   "
78245|NCT02033226|"~     The objective of this study is to evaluate the anti-inflammatory and anti-infective~     properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in~     periodontal bone defects.~   "
78246|NCT02033213|"~     An exploratory single-centre randomized clinical trial was performed in order to investigate~     whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary~     gas exchange and tissue perfusion.~   "
78247|NCT02033200|"~     The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,~     pupil dilation, and color vision in healthy males.~   "
78248|NCT02033187|"~     Healthcare-associated infections are a major cause of morbidity among critically ill~     patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum~     antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections.~     The purpose of this study is to evaluate the effect of daily bathing with disposable~     chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable~     standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated~     infections in critically-ill patients.~      Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will~     result in reduced rates of healthcare-associated infections in patients admitted to~     intensive care units (ICU).~   "
78249|NCT02033174|"~     Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will~     decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in~     healthy people after a five days period.~   "
78250|NCT02033161|"~     This pilot-study aims to evaluate the treatment effects and feasibility of an~     internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.~   "
78251|NCT02033148|"~     This phase I trial studies the side effects and best dose of icotinib hydrochloride in~     treating patients with advanced cancers. Icotinib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
78252|NCT02033135|"~     This randomized clinical study is intended to evaluate the use of Zilver PTX stents for~     treatment of thigh atherosclerosis.~      Research question: Is there an adjuvant benefit of angioplasty and stenting using the new~     paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy~     alone in patients with stable, mild to moderate intermittent claudication caused by~     femoropopliteal lesions suitable for endovascular management.~   "
78253|NCT02033122|"~     Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical~     outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation,~     characteristic features in asthma, remains poorly understood. We aim to investigate the~     effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim).~     In addition, clinical control and health related quality of life (HRQoL) will be also~     assessed.~   "
78254|NCT02033109|"~     This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse~     transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the~     prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc~     acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150,~     the first time MIV-150 will be administered topically, and the first time MIV-150 will be~     administered intravaginally.~   "
78255|NCT02033096|"~     Follow-up, Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202~   "
78256|NCT02033083|"~     Primary objective: To study the difference in dilation and evacuation (D&E) procedure time~     following overnight cervical preparation with laminaria or Dilapan-S™. The investigators~     hypothesize procedure time will be less with Dilapan-S™.~      Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1)~     initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and~     ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete~     the D&E procedure without further cervical preparation; (5) complications; (6) pain and~     other side effects; (7) patient acceptability; and (8) provider acceptability.~   "
78257|NCT02033070|"~     The purpose of this study is to provide a tool for physicians to compare outcome data~     related to the use of the HALO Ablation Systems. This study is a single-center patient~     registry which will contribute to a framework for treatment and follow-up of patients with~     Barrett's Esophagus.~   "
78259|NCT02033044|"~     Study design was a multicenter, randomized, rater-blind clinical trial. There were~     two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a~     specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational~     group intervention (PE) in subjects with Borderline Personality Disorder (BPD).~   "
78260|NCT02033031|"~     Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in~     patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.~      Visual recovery depends on ischemic damage of the retina, the occurence of macular edema~     (ME) and the development of neovascular glaucoma. The occurence of ME is the main reason for~     visual loss and frustrates visual recovery among patients with both central or branch RVO.~      Therapeutic options that have been used and discussed over the years are the treatment with~     anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution.~     Furthermore, surgical options like vitrectomy and radial optic neurotomy were used.~     Panretinal photocoagulation and grid pattern photocoagulation had established as additional~     tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence~     of these different treatment options could not be verified and remains mostly unknown.~      Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME~     secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF~     treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE).~     Unfortunately, often high numbers of re-treatments become necessary over the years. In our~     knowledge, there are no reports showing more than 3 years treatment effects of~     antiangiogenic drugs in patients with BRVO. However, the results of treatment effect longer~     than 3 years are important, as the mean age < 70 years with an onset of BRVO has been~     estimated in about 60% of all cases. In addition, most patients with regard to the~     application of anti-VEGF treatment in real clinical setting, there is only rare experience~     concerning need of optimum time duration for follow-up at the departments. Hence, the~     present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic~     benefit of a flexible dosing regimen of intravitreal anti-VEGF therapy in patients with ME~     secondary to BRVO.~   "
78261|NCT02033018|"~     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal~     injections (IVT) in CNV secondary~   "
78262|NCT02033005|"~     Breast feeding is believed to be beneficial to long-term health but how these effects are~     mediated is unknown. I suggest that this may be through effects on body composition and~     metabolism.~      I will compare adipose tissue and liver fat deposition in healthy, full term breast and~     formula fed infants babies shortly after birth and around 12 weeks.~   "
78263|NCT02032979|"~     The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles~     of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2~     FSHD study. For this, the investigators relied on observational components: FSHD2 patients~     appear more often present with psychiatric comorbidities and seem to have lower cognitive~     performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small~     sample population of patients. It seems to exist mainly executive dysfunction associated~     with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be~     low in relation to their socio-educational and compared with patients FSHD1 level.~   "
78264|NCT02032966|"~     Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an~     ankle fracture in which both the tibia and the fibula are broken. This would alleviate the~     need for another incision, plate, and screws to repair the fibula. The purpose of this study~     is to help determine if surgically repairing only the tibia fracture will lead to equivalent~     clinical outcomes when compared with surgical repair of both bones.~      The hypothesis of this study is that operative stabilization of the medial malleolus~     fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures~     of the ankle, will lead to equivalent clinical outcomes and functional scores as those~     treated with operative stabilization of both malleoli and/or all malleoli.~   "
78265|NCT02032953|"~     The purpose of this study is to find out whether adding insulin after current colorectal~     cancer surgery promotes making and keeping proteins in the body, and to find out whether or~     not this effect can be further increased by increasing the amount of protein given.~   "
78266|NCT02032940|"~     The purpose of the study is to create MR images using an investigative technique called~     pulse sequences with new computer software programs. The sequence will allow us to image~     vessels without injecting contrast agents.~   "
78267|NCT02032927|"~     Osteoarthritis is a common joint disorder in the elder population.The current treatment~     options include both a non-pharmacological approach (physiokinesitherapy, diet) or if this~     fails, a pharmacological approach that relies in the first instance on drugs such as~     paracetamol, non-steroidal anti-inflammatory (including inhibitors of cyclo-oxygenase).~     However, the use of these drugs is limited, by the roof effect concerning analgesia, and by~     the potential side effects. When pharmacological treatments with non-opioid medications~     fail, and a moderate-to-severe pain reduces the quality of life of the patient,~     international guidelines suggest the use of opioid drugs.~   "
78268|NCT02032914|"~     Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions,~     the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not~     evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of~     cryptogenic pyogenic liver abscess by colonoscopic examination.~   "
78269|NCT02032901|"~     To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C~     virus (HCV) Genotype 3 infection~   "
78270|NCT02032888|"~     A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the~     treatment of hepatitis C virus and HIV coinfection.~   "
78271|NCT02032875|"~     This trial was open to participants who had received a liver transplant or had cirrhosis due~     to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were~     followed for 24 weeks post treatment. Under certain conditions, the treatment duration could~     have been extended for cirrhotic participants. The study tested the efficacy and safety of~     this combination for treatment of HCV in cirrhotic and post transplant patients.~   "
78272|NCT02032862|"~     Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application~     over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot~     flushes daily and a Hyperhidrosis Scale score ≥ 2~   "
78273|NCT02032849|"~     This is a randomized controlled trial compared two methods to drainage subglottic secretion~     in prolonged intubated patients.After enrolled, patients are randomized assigned to~     intermittent subglottic secretion drainage group and air-impingement manipulation group.~   "
78274|NCT02032836|"~     Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb~   "
78275|NCT02032823|"~     Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative~     primary breast cancer who have completed definitive local treatment and neoadjuvant or~     adjuvant chemotherapy~   "
78276|NCT02032810|"~     The purpose of this study is to find out if an investigational drug called panobinostat can~     be given safely with another drug called ipilimumab. Investigators want to learn more about~     the side effects of this combination of drugs using different doses of panobinostat and the~     same dose of ipilimumab.~   "
78281|NCT02032745|"~     A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based~     chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively~     evaluate the microarray-based, genomic test as a predictor of axillary lymph node response.~     Also, to determine whether the probability of achieving negative axillary nodes, is~     sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to~     support omitting axillary dissection.~   "
78282|NCT02032732|"~     Pediatric joint infections are a common diagnostic dilemma encountered by treating~     orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in~     determining the presence of joint infection.~      The purpose of this study is to test the usefulness of a chemical test strip to detect~     infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric~     patients. The test strip measures an enzyme called leukocyte esterase, which has been shown~     to be useful in detecting the presence of infection in fluids from other parts of the body.~     This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for~     evaluating pediatric joint infections. The hypothesis of the study is that a positive~     leukocyte esterase test identifies a septic joint in pediatric patients undergoing~     intraoperative joint aspiration.~   "
78283|NCT02032719|"~     Patients who receive smartphone-assisted health coaching will have a significantly lower 24~     hour ambulatory blood pressure mean than patients who receive just health coaching~   "
78284|NCT02032706|"~     The purpose of this study is to assess the accuracy of Night Shift in the detection of~     supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.~   "
78285|NCT02032693|"~     The investigators are conducting this research because they want to determine if a dietary~     supplement, called Everycell™, has an effect on the functioning of the study participants'~     cells. The results of this research will be used to help develop additional strategies for~     trying to fight the effects of aging. The primary purpose of this study is to determine the~     effectiveness of Everycell™ compared to placebo (a pill that does nothing) on DNA damage,~     inflammation, stress, and related factors. Taking Everycell™ is not a medical prescription,~     treatment, or cure for any known disease or condition.~      Helping patients' nutritional status is important to prevent the continued worsening of~     chronic diseases and also to counteract the effects of aging. Americans also have~     difficulties with compliance to prescription medications due to their toxicity and side~     effects. This study aims to learn more about how a dietary supplement may improve~     nutritional status and enable the body to normalize cellular functioning, which may improve~     quality of life. The results of this research will be used to determine if Everycell™ is~     beneficial for overall cellular health and to counteract the effects of aging.~   "
78286|NCT02032680|"~     As specified in the VA Uniform Services Handbook, Family Psycho-Education (FPE) treatment~     must be available to all Veterans with schizophrenia who could benefit, and their family~     members. This includes those receiving care at Community Based Outpatient Clinics (CBOCs),~     and at Psychosocial Rehabilitation and Recovery Centers (PRRCs), whether provided on site,~     by referral, or by telemental health. However, less than 5% of VA medical centers offer FPE.~     Clearly, a major challenge is to devise ways to deliver mental health treatments and~     services to Veterans who need them in ways that meet their needs and preferences. The~     proposed project will compare the use of a website to deliver FPE to that of in-person~     delivered FPE. The findings could have profound implications for the VA's ability to improve~     the reach, use, appeal, and effectiveness of FPE for Veterans with schizophrenia, by using~     an e-health model that facilitates family involvement.~   "
78287|NCT02032667|"~     This study will be investigating an innovative and exciting way to increase physical~     activity in children between the ages of 9 and 12 years old. Families will be provided with~     a state-of-the-art exercise bike and video game console to have in their homes. The video~     games will provide a variety of play including racing, puzzle solving, collaborative play,~     team play and competitive play. We will be comparing whether a 'multi-player' condition has~     a greater adherence compared to a 'single-player' condition.~   "
78288|NCT02032654|"~     Cellulitis is among the most common infections leading to hospitalization, yet the optimal~     duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days~     of antibiotics, which is the current standard of care. Recently it has been shown that~     antibiotic treatment for pneumonia and urinary tract infections can safely and significantly~     be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis~     with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no~     difference in outcomes when patients hospitalized with cellulitis are treated with either a~     short-course (6 days) or standard-course (12 days) of antibiotics.~   "
78289|NCT02032641|"~     The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium~     aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar~     after direct brow lift.~   "
78290|NCT02032628|"~     Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators~     will demonstrate a dose-response relationship between volume of aerobic exercise and changes~     in DNA methylation over four months among previously sedentary women.~      Specific aim 2. There are no published data on the extent to which positive effects of~     exercise on methylation might decay if exercise is not continued. The investigators will~     gather data on the natural history of methylation decay after training.~   "
78291|NCT02032615|"~     To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of~     anemic subjects longitudinally.~      To quantify the demographics of subjects attending anemia testing camps through LBWR and to~     explore correlations with the demographics data.~   "
78302|NCT02032472|"~     Background: Hypertension in adults is the factor most prevalent cardiovascular risk and~     motivates further inquiries, generating a very high cost of medical care.~      Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy~     Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be~     as effective in obtaining good control of blood pressure as it is to obtained through health~     centers. Design: Multicenter randomized controlled trial along one year of follow up.~     Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients~     diagnosed with hypertension and good control criteria in the past year. Arms: Health centers~     (control) and Pharmacy Offices (intervention). Outcome variable: blood pressure under good~     control along the monitoring~   "
78292|NCT02032602|"~     Background: Non-specific shoulder pain has a high prevalence in older adults and provokes~     functional alterations. Besides, there are difficulties for its clinical diagnosis, lack of~     effectiveness in the treatment and not much evidence is found regarding invasive physical~     therapy techniques in this population.~      Purpose: To determine the efficacy of a single physical therapy intervention with deep dry~     needling on latent and active myofascial trigger points in older adults with non-specific~     shoulder pain.~      Methods: Pilot Study, Single Blind Randomized Controlled Clinical Trial on 60 subjects aged~     65 and over, will be diagnosed with nonspecific shoulder pain. The study will be approved by~     the Clinical Research Ethics Committee of the area. Sample will be recruited at their home~     and at a care center, and randomly will be distributed in Experimental Group (n=30), which~     will be received a session of Deep Dry Needling on an active and a latent Myofascial Trigger~     Points of the infraspinatus muscle; and Control Group (n=30), receiving a session of Deep~     Dry Needling only on an active Myofascial Trigger Point. A blind examiner will be evaluated~     Pain Intensity, Pain Pressure Threshold (anterior deltoid; extensor carpi radialis brevis)~     and Grip Strength, before, immediately after intervention and after a week of treatment.~   "
78293|NCT02032589|"~     Past research has shown that items self-generated by an individual, such as words or~     concepts, are remembered better than items that are simply read or heard. The current study~     seeks to demonstrate the effectiveness of using the principles of the generation effect in a~     treatment intervention to improve memory and functional performance in individuals with~     Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study~     is to conduct an experimental investigation on the effects of a self-generation strategy~     treatment, embedded within practice of various activities ranging from laboratory tasks~     (e.g. words and concepts) to functional tasks (e.g. activities of daily living). The~     treatment to be tested is geared toward helping patients selfdiscover their own strengths~     and abilities while using self-generation to be able to utilize it independently in everyday~     life situations.~      Design: The proposed pilot study is a randomized clinical trial. Participants: Participants~     will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate~     memory impairments. Half of the participants will receive the self-generation training while~     learning different types of tasks (experimental group) and half of the participants (control~     group) will be asked to learn the same information but will receive a conventional practice~     (e.g. repetitions).~      Expected results: We expect that participants undergoing the self-generation-training~     intervention will show better memory performance, functional performance, quality of life,~     and satisfaction with treatment and life compared to participants in the control condition.~   "
78294|NCT02032576|"~     Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive~     therapy (ECT) response. Although ECT is highly effective for treatment of patients with~     major depressive episode, a high rate of relapse/recurrence is a major problem after~     discontinuation of ECT. The purpose of this study is to examine the factors related to the~     response of ECT, to predict ECT response early, and to investigate the clinical predictors~     affecting the time to relapse/recurrence after ECT.~      Methods: Patients with major depressive episode who require ECT treatment will be enrolled.~     ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17)~     and other scales will be assessed before ECT, after every 10 days, till to an expected~     average of 50 days, and monthly during the 6-month follow-up period. Other measures also~     will be performed before the first ECT, at an expected average of 50 days, and at the end of~     follow-up period. Predictors of the response and relapse/recurrence after ECT and early~     prediction of ECT response will be obtained by statistic methods.~   "
78295|NCT02032563|"~     We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after~     neoadjuvant therapy (chemo- or hormonotherapy)~   "
78296|NCT02032550|"~     The purpose of this study is to develop a preference based decision aid to assess the~     treatment preferences of prostate cancer patients, and to analyze the interaction of~     treatment preferences, type of treatment received and their relationship with health related~     quality of life, satisfaction with care, decision regret, and psychological health of men~     with localized prostate cancer.~   "
78297|NCT02032537|"~     Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced~     chronic kidney disease (CKD) and end-stage renal disease (ESRD).~      Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli~     pharmaceutical company developed a topical cream based on active plant extracts for~     treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo~     controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP~     in a cohort of CKD and ESRD patients.~   "
78298|NCT02032524|"~     Primary Objective:~      Long-term safety and pharmacokinetics (PK) of neoGAA~      Secondary Objective:~      Long-term effect of neo-GAA on pharmacodynamic and exploratory efficacy variables~   "
78299|NCT02032511|"~     This study is designed to compare the effectiveness and ease of use of two commonly used~     NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.~   "
78300|NCT02032498|"~     The revision of our data shows that since its introduction in our institution (Jules Bordet~     Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent~     neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional~     axillary dissection.~      The analysis of these cases shows that:~        -  The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is~          associated in 75% of them with a pN+ status~        -  If scintigraphic imaging is positive (demonstration of the sentinel lymph nodes: 35~          cN0 and 10 cN+), our results appear favorable with a single false negative SLN result~          (False Negative Rate = 1/20 or 5%).~      Therefore we propose additional technique for LN detection by indocyanine green, we~     hypothesize that the combination of two different injections improves the technique of~     sentinel lymph node biopsy.~   "
78301|NCT02032485|"~     The purpose of this study is to determine if Near-Infrared fluorescence imaging is an~     effective approach to detect the colorectal tumoral tissues and peritoneal implants in~     colorectal cancer patients.~   "
78314|NCT02032316|"~     A prospective, single-center, single-arm, trial to demonstrate safety and device performance~     of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man~     clinical study in a small human population.~   "
78303|NCT02032459|"~     Vitamin D is present in food either naturally or by fortification and included in~     nutritional supplements. It is also synthesized photochemically by the skin from ultraviolet~     B radiation. Vitamin D synthesis varies by season and with latitude as well as according to~     intensity of skin pigmentation. Recent research in the United States found lower circulating~     levels of 25 (OH) D, the primary indicator of vitamin D status, among minority women who~     were either pregnant or in their reproductive years. The extent to which maternal vitamin D~     has an influence on the course and outcome of human pregnancy remains to be more completely~     studied. We propose to use the HPLC method to assay cholecaliferol (vitamin D3) and~     ergocalciferol (vitamin D2) to assess maternal vitamin D status. This will be accomplished~     by analyzing existing fasting samples and data derived from the 2001-2006 cohort (N=1141) of~     young, low income minority gravidae from Camden, New Jersey to determine:~        1. The prognostic importance of maternal vitamin D status for birth weight, gestation~          duration and poor pregnancy outcomes (low birth weight, preterm delivery, fetal growth~          restriction).~        2. The relation of maternal vitamin D status to important complications of pregnancy~          (gestational diabetes and pre-eclampsia).~        3. The relationship of maternal vitamin D status to maternal diet and supplement use,~          season of year, ethnicity, overweight/obesity, and other maternal characteristics.~   "
78304|NCT02032446|"~     MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent~     therapeutic effects in the treatment of severe steroid-resistant acute Graf versus Host~     Disease. Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal~     cells administration has been found consistently negligible. The investigators believe that~     Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger~     immunosuppressive tool for such clinical emergency and no data suggest any change in the~     safety profile of these cells. For this reason, and in the best interest of the patient, the~     investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal~     cells when given sequentially to another partially effective treatment of steroid resistant~     acute graf versus host disease such as Pentostatin.~   "
78305|NCT02032433|"~     CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone~     (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention~     of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high~     affinity partial agonist indicated for maintenance treatment of opioid dependence, as~     pharmacotherapeutic aids to recovery.~      The study is conducted in 8 NIDA Clinical Trials Network affiliated community based~     treatment programs. Up to 600 eligible participants will be randomized to treatment with~     XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized~     more than 72 hours after their last opioid).~      The primary goal of the study is to estimate the difference, if one exists, between XR-NTX~     and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence)~     during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus~     BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore~     demographic and, clinical, and genetic predictors of successful treatment and moderators of~     differential effectiveness (i.e., what variables may help clinicians choose which of these~     treatments is best for a given patient).), and (3) collect a limited dataset to permit~     analyses of economic costs and benefits of the two treatments.~   "
78306|NCT02032420|"~     Volunteers will watch a training video demonstrating how to place a needle in the correct~     position while keeping it visible. Later the volunteers will be placed in front of a set up~     identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk~     needle into 3 targets in a standardized homemade phantom a total of three times.~   "
78307|NCT02032407|"~     This study will evaluate the effect of dapsone gel in female subjects with skin of color~     (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.~   "
78308|NCT02032394|"~     This study is conducted to determine and compare the effect of applying Povidone-iodine and~     Chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with~     urinary catheter in intensive care unit.~   "
78309|NCT02032381|"~     Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of~     malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric~     allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC),~     to evaluate the prevalence and course of PFT abnormalities before and after transplant, and~     to detect risk factor for PC.~   "
78310|NCT02032368|"~     Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial~     chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.~   "
78311|NCT02032355|"~     Maternal hypotension is a common side effect after spinal anesthesia for cesarean~     delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and~     blood pooling in blocked areas of the body respectively, are main causes of spinal~     anaesthesia-induced hypotension during Caesarean delivery.~      Cardiac output, which has shown to be a better predictor of organ and placental perfusion~     than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the~     maternal population.This is largely because of the lack of availability of accurate and~     reproducible noninvasive measurement techniques. Up to now, preventing hypotension has~     continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements~     as markers of cardiovascular status, because these are more easily measured.~      Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension~     during spinal anaesthesia, would also have a positive and significant association.~   "
78312|NCT02032342|"~     Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated~     lobe during thoracic surgery while the other lobes are ventilated. It is associated with the~     improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with~     providing adequate surgical access. The purpose of this study is to compare the efficacy of~     three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen~     Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar~     collapse.~   "
78313|NCT02032329|"~     The purpose of this study is to assess efficacy of a pre-commercial device capable of~     activating both the ankle plantarflexor and dorsiflexor muscles using electrical stimulating~     during treadmill-based gait training for stroke patients.~   "
78315|NCT02032303|"~     Study design Investigators aim to perform a prospective, single-center,~     investigator-initiated, randomized study to compare the Adenosine-induced coronary~     vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous~     Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous~     Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio,~     to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with~     non-ST elevation myocardial infarction these drugs will be administered only when the~     coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for~     coronary artery bypass grafting as recommended by European Society of Cardiology guidelines~     (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and~     ticagrelor will be administrated before the procedure, according to the European Society of~     Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by~     intracoronary Doppler Flow Wire before the stent implantation and after the procedure at~     baseline and 2-minute later adenosine intravenous administration at incremental doses of 50,~     80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.~      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to~     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio~     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured~     in patients with acute coronary syndrome, without an increased risk of adverse events for~     patients neither adjunctive costs for the National Health System.~      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will~     be measured in venous blood collected at the end of the procedure. . In patients requiring a~     second Percutaneous Coronary Intervention, for example for multivessel disease, all these~     measures will be repeated in the same manner.~   "
78316|NCT02032290|"~     The administration of these drugs is realized according to the European Society of~     Cardiology guidelines.~      All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an~     activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or~     clopidogrel (600 mg) immediately before the revascularization. The list of assignment to~     ticagrelor or clopidogrel will be generated by a computer according to a 1:1 randomization.~     Primary Percutaneous Coronary Intervention will be performed according to standard clinical~     practice using femoral or radial artery Judkins approach via six or seven French heath~     insertion. After crossing the target occlusive Lesion, coronary stenting will be performed~     based on standard practice. Patients subsequently will receive heparin for 48 hr, aspirin~     100 mg daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12~     months. Other adjunctive pharmacotherapy in Intensive Care Unit will be administered~     according to operator discretion. All patients will provide written informed consent before~     entering the study.~      Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as~     standard practice. Then, all the pre-, intra-, and post-procedure data patients will be~     collected in a database.~      Investigators aim to perform a prospective, single-center, investigator-initiated,~     randomized study to compare the Adenosine-induced coronary vasodilatation after the loading~     dose of Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention.~     Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be~     enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of~     Ticagrelor (180 mg) or Clopidogrel (600 mg). Coronary Flow Reserve will be recorded by~     intracoronary Doppler Flow Wire before the stent implantation and after the procedure at~     baseline and 2-minute later adenosine intravenous administration at incremental doses of 50,~     80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.~      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to~     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio~     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured~     in patients with Acute Coronary Syndrome, without an increased risk of adverse events for~     patients neither adjunctive costs for the National Health System.~      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will~     be measured in venous blood collected at the end of the procedure. In patients requiring a~     second Percutaneous Coronary Intervention, for example for multivessel disease, all these~     measures will be repeated in the same manner.~   "
78317|NCT02032277|"~     This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of~     veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant~     chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.~   "
78318|NCT02032264|"~     To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy.~     All viable blastocysts will be biopsied and cryopreserved for future transfer. After the~     final embryo is cryopreserved, patients will be randomized to either the intervention group~     or the control group. Patients and doctors are blinded to the randomization until study~     completion. A Double Embryo Transfer (DET) will be performed with either screened or~     unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in~     cases where only one embryo is available for transfer.~   "
78319|NCT02032251|"~     This study is a randomized, double blind, controlled clinical trials assess the efficacy of~     the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.~   "
78320|NCT02032238|"~     The purpose of this is study is to assess the efficacy of navigated laser treatment in~     reducing the number of anti-VEGF injections required to maintain visual gain obtained after~     Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular~     edema (CSME).~      This will be prospective, active-controlled study using Bevacizumab (Genentech, South San~     Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas~     Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.~   "
78321|NCT02032225|"~     Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy~     (CADASIL) is an archetypal small vessel disease of the brain caused by dominant mutations in~     the NOTCH3 receptor. Cardinal vascular lesions include deposition of granular osmiophilic~     material (GOM) within the basal lamina of smooth muscle cells, progressive smooth muscle~     cell loss, and fibrosis of the media. Pathogenic mutations alter the number of cysteine~     residues in the extracellular domain of NOTCH3 (Notch3 ECD), leading to its abnormal~     accumulation in the GOM deposits. Vascular smooth muscle cell has been identified as the~     primary target cell in this disease. Pathophysiological processes leading from NOTCH3~     mutations to smooth muscle cell loss remain poorly understood.~      The investigators propose to study these mechanisms by reprogramming skin cells to become~     stem cells and then differentiating them to vascular smooth muscle cells.~      The hypothesis of this study is that the differentiated smooth muscle cells will display the~     characteristic features of CADASIL, ie, Notch3 ECD accumulation and GOM deposits.~   "
78322|NCT02032212|"~     Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are~     otherwise known as electronic cigarettes. These may look like conventional cigarettes but do~     not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the pharmacokinetic profile of an EVP.~   "
78340|NCT02031978|"~     The goal of the study is to be a current examination of infant and toddler feeding practices~     among families receiving WIC services. It has been more than 10 years since the last study~     of such feeding practices, and in the interim important changes have taken place in the WIC~     program, in society, and in the science of nutrition. The study will include exploration of~     breastfeeding practices and support, more general feeding practices, nutritional intake of~     infants and toddlers, transitions in infant and toddler feeding practices, early precursors~     of obesity, and family factors that may influence all of these nutrition-related issues. It~     will also explore characteristics of the WIC program in selected sites, and how these relate~     to infant and toddler feeding decisions and practices. This study is important both to~     update knowledge about the WIC population, and to uncover possible new avenues of inquiry~     regarding early childhood obesity.~   "
78323|NCT02032199|"~     A central goal of health care is to maximize patient functioning and well-being. This has~     prompted measurement of health-related quality of life (HRQOL) that encompasses physical,~     psychological, and social functioning. While obese people have generally impaired HRQOL,~     people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese~     individuals seeking non-surgical treatment or obese individuals not seeking weight-loss~     treatment. HRQOL improves significantly after bariatric surgery, but often with large~     individual variations in outcome. As gastric bypass is an invasive procedure with~     irreversible influences on eating behaviour and possible serious adverse events, it is~     important to identify potential risk factors for a poorer long-term result. In Denmark,~     bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines~     Authority guidelines, which until 2011 were in line with international guidelines. However,~     in 2011 access to surgery was dramatically restricted and the annual number of operations~     reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The~     restrictions involved a tightening of the criteria for patients without manifest obesity~     comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing~     the lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling~     the tighter criteria benefit more from surgery than patients who only met the previous~     criteria.~      This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up~     over an average of 22 months. The aim was to explore whether postoperative HRQOL variations~     were associated with identifiable socio-demographic or clinical characteristics. In~     particular, whether HRQOL changes differed for patients fulfilling the current Danish~     criteria and patients only fulfilling the previous criteria.~   "
78324|NCT02032186|"~     The investigators propose a preventive strategy that may reduce the risk of placental~     vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth~     or stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in~     turn, should reduce the need for indicated preterm delivery. This strategy is a multicenter,~     randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate~     supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until~     delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by~     the intestinal tract. The results of this RCT may be especially relevant in low and middle~     income countries that have high rates of prematurity, and limited resources for acute~     newborn and maternal care.~   "
78325|NCT02032173|"~     To evaluate a new treatment regimen with a spaced out follow-up after an initial intensive~     treatment phase in patients with reduced visual acuity due to diabetic macular edema (DME).~   "
78326|NCT02032160|"~     The purpose of this study is to generate an exploratory training set of data and to identify~     predictive biomarkers (a measurable biological response that predicts something) of innate~     and adaptive responses to immunisation of two vaccines utilizing different adjuvant~     technology given according to approved schedules to healthy adult volunteers. The vaccines~     are model agents selected as they match antigens but have discordant adjuvants, have a known~     immunogenicity profile, assays are freely available to measure responses, and they are safe~     to administer to healthy adults at the doses and schedules proposed. This study will strive~     to correlate biomarker activity with observed immunological responses to vaccination and if~     successful, these biomarkers could be used in early stage clinical trials to optimize~     selection of vaccine candidates with a profile that will be most likely to be effective once~     they are in generalized use.~   "
78327|NCT02032147|"~     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation~     therapy for cancers, and may have a devastating effect on the patient's quality of life~     (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard~     therapy has been suggested for CRN. In our clinical practice, we have used nerve growth~     factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has~     been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this~     prospective study to test the efficacy of NGF for CRN.~   "
78328|NCT02032134|"~     The increasing need for blood components and the increasingly careful donor selection~     procedures, make the availability of blood components very reduced, in particular for~     platelets that are currently administered preferably fresh or cryopreserved, only in~     emergency conditions.~      Exceeding this limit through the spread of use of cryopreserved platelets in the common~     clinical practice, might help clinicians to avoid wasting valuable products and face periods~     of particular shortage of donors Some studies already published in the literature over the~     last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved~     platelets .~      The main objective of the proposed study is to evaluate the efficacy and safety of~     platelets, cryopreserved with DMSO using a a new method, in patients with severe~     thrombocytopenia.~      This is the in vivo phase of a study where availability and efficacy of cryopreserved~     platelets has been assessed in vitro.~   "
78329|NCT02032121|"~     Survivors of childhood cancer have an increased risk of death from cardiovascular disease~     due to both the therapies they received while undergoing treatment and diet and lifestyle~     factors. The nature of cardiovascular risk and the interaction between treatment affects and~     cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as~     well as measure of blood vessel stiffness (both of which are predictive of early heart~     disease) in 100 pediatric cancer survivors and 100 control children. Characterization of~     vascular inflammation and stiffness in long-term survivors will allow for the development of~     future interventions to decrease inflammation through both pharmacologic and lifestyle~     modifications.~   "
78330|NCT02032108|"~     Strategies to reduce the burden of diabetes in Rwanda, like in other resource poor settings,~     include involving diabetic patients in their own care and targeting modifiable risk factors~     through adopting appropriate dietary and lifestyle habits. According to previous research~     carried out in developed countries, lifestyle modifications may have effect on the~     development of diabetes and prevention of its complications.~      However, direct evidence to show whether lifestyle intervention is beneficial for diabetic~     patients in resources limited countries like Rwanda is an open question. Though in these~     countries, access to healthy diet is claimed to be the barrier of implementation of~     therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more~     important barriers than access to healthier diets and other lifestyle habits. We therefore~     would like to carry out this intervention to assess the effects of lifestyle education~     programs on glycemic control among people with diabetes followed up at CHUK.~   "
78331|NCT02032095|"~     It is intended to examine the safety and efficacy of desensitization therapy by GB-0998~     (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of~     pre-transplant desensitization. Patients with positive FCXM-T after performing twice double~     filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.~   "
78332|NCT02032082|"~     Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung~     function in small animals. It also has been shown to be a useful technique to evaluate lungs~     from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been~     recently demonstrated successful application of an acellular EVLP technique in optimalizing~     lung function ex vivo for an extended period of time. Following 12 h of normothermic EVLP,~     patients were transplanted and demonstrated immediate life-sustaining function with~     promising short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung~     Transplant, 2012; Cypel, N Engl J Med, 2011).~      Lung donation obtained after carbon monoxide intoxication has been recognized as excellent~     organs because of less general inflammation and less primary graft dysfunction after~     procedure. In a murine model of brain dead, carbon monoxide inhalation at a low~     concentration (50 to 500 parts per million (ppm)) exerts significant cytoprotection in~     several lung injury models via its vasodilatation, anti-inflammatory, and anti-apoptotic~     properties (Dong, J Heart Lung transplant, 2010). The carbon monoxide inhalation~     down-regulates pro-inflammatory cytokines (TNF-alpha, IL-6) along with the increase of~     anti-inflammatory cytokine (IL-10) in recipient serum. The inhalation significantly~     decreases cell apoptosis in lung grafts, inhibiting mRNA and protein expression of~     intercellular adhesion molecule-1 (ICAM-1) and caspase-3 in lung grafts (Zhou, Chin Med J,~     2008).~      Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the~     field of biomarkers is now opening new perspectives with the development of non-invasive~     tests allowing for monitoring inflammation and damage in the deep lung. Blood tests~     (Bernard, Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins)~     such as Clara cell protein (CC16) and surfactant-associated proteins (A, B or D) are now~     available to evaluate the permeability and/or the cellular integrity of the pulmonary~     epithelium. These dosages may constitute an interesting way for monitoring the quality of~     the lung before implantation.~   "
78333|NCT02032069|"~     Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after~     lung transplantation, shares key clinical and pathological features with acute lung injury~     and its more severe form, the acute respiratory distress syndrome. However, in contrast to~     acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine~     and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in~     primary graft dysfunction has been less thoroughly explored. We will try in this study de~     determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the~     recipient.~   "
78334|NCT02032056|"~     The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided~     for 6 mo, on the prevalence of infections and allergic manifestations in small children, and~     how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children~     are enrolled during 2 winter seasons.~   "
78335|NCT02032043|"~     Approximately 4,000 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis and onchocerciasis endemic~     areas. Subject selection will not be based on health status.~      Two sites will be studied, and each study will last for 4 years. Participants will be~     studied only once in cross-sectional surveys. Some subjects may be included in more than one~     annual population survey, but this is not a longitudinal study.~      Investigators will compare annual and semiannual mass drug administration (MDA) for~     lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these~     MDA schedules on soil transmitted helminth infections. MDA will be administered by others~     (Ivorian Ministry of Health).~      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is~     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for~     control of soil transmitted helminth (STH) infections.~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.~        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of onchocerciasis in these populations.~        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
78336|NCT02032030|"~     Based on limited published epidemiological data, up to an alarming 1 in 50 surgical~     inpatients die within 30 postoperative days. Based on our own data from the B-Unaware~     (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality~     among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and~     1-year mortality among high-risk surgical patients may be as high as 10%. Short- and~     intermediate-term postoperative mortality is therefore a pressing public health concern.~     Similarly, postoperative major morbidity - including delirium, stroke, myocardial~     infarction, atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia,~     respiratory failure, loss of functionality, and chronic pain - occurs commonly and affects a~     substantial proportion of surgical patients, critically ill patients and patients undergoing~     procedures for chronic pain. Many factors associate strongly and independently with~     postoperative mortality and major morbidity: patient age, functional status, comorbid~     medical conditions, and duration and invasiveness of surgery, among others. It is a~     strategic priority to identify pre- and intraoperative risk factors that are subject to~     modification.~   "
78337|NCT02032017|"~     The purpose of this study is to investigate whether revalidation following total hip~     replacement through the percutaneous approach is faster or better than following the~     anterolateral approach. We assume this would be the case since it is possible to spare a~     large part of the gluteus medius muscle with the percutaneous approach.~   "
78338|NCT02032004|"~     The primary objective of this study is to determine whether transendocardial delivery of~     allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment~     of chronic heart failure due to LV systolic dysfunction.~   "
78339|NCT02031991|"~     This study is to prove that the handling (also referred to as pharmacokinetics) of the~     following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United~     States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is~     similar in healthy male volunteers after receiving a single intravenous dose of either~     drugs.~      During the course of the study, the similarity in pharmacokinetics will be assessed by~     sampling the levels of drug in the blood, and by comparing these levels among the different~     administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability,~     and immunologic response to the administered drugs will also be evaluated throughout.~   "
78341|NCT02031965|"~     This phase I trial studies the side effects and the safety of injecting HSV1716 (a new~     experimental therapy) into or near the tumor resection cavity. The injection will be done at~     the time of surgery. HSV1716 is a virus that has a gene which has been changed or removed~     (mutated) in such a way that lets the virus multiply in dividing cells of the tumor and~     kills the tumor cells.~   "
78342|NCT02031952|"~     The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC)~     patients in clinical practice. While many patients suffered the recurrence without the~     evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the~     value of preventive resection of regional lymph node for those patients. Recently, more and~     more studies had found the incidence of lymph node metastasis was higher in autopsy specimen~     than those in operable patients.~      This project is a prospective randomized controlled trial, planning to compare hepatectomy~     with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC~     patients, to reach a further understanding of the role of lymphadenectomy.~   "
78343|NCT02031939|"~     Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local~     recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue~     probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant~     treatment. Induction chemotherapy is one of the most studied strategies. However, the~     efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial.~     In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant~     chemoradiotherapy can improve response rate of rectal cancer patients, but the results have~     not been confirmed in clinical trial. Whether this new kind of treatment can optimize~     neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in~     clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.~   "
78344|NCT02031926|"~     Healthy subjects will be trained to used correctly a positive expiratory pressure device.~     The aim of the study is to evaluate te reproductibility of the correct used of the device~     after training~   "
78345|NCT02031913|"~     Hepatic steatosis and insulin resistance are associated with severity of fibrosis in~     non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical~     significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is~     not well established. The aim was to investigate the relationship between insulin~     resistance, hepatic steatosis, and fibrosis in patients with CHB.~   "
78346|NCT02031900|"~     This is a single center, single arm, open label observational trial of patients undergoing~     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians~     to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to~     identify and discriminate abnormal areas of tissue from normal.~   "
78347|NCT02031887|"~     The primary objectives of this trial are:~        -  to show differences in the colonization of the gastrointestinal tract with the bacteria~          Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the~          test or a control product~        -  to investigate whether there is equivalence in growth between the four different groups~          of infant described above.~   "
78348|NCT02031874|"~     Immunosuppressed patients are at increased risk for complications of influenza infection,~     including secondary pneumonia and are recommended for annual influenza vaccination. Thus,~     the appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus~     has added an extra layer of complexity in the immunization regimen in this population. In~     general, susceptibility to swine H1N1 infection among young population is higher as young~     adults and children completely lack protective titers. According to the Center for Disease~     Control (CDC), 70 percent of people hospitalized with H1N1 have been high risk cases,~     including persons 65 years of age or older, or people with compromised immune systems as~     observed during HIV infection. This has prompted CDC to include HIV infected children to be~     one of the five groups to be vaccinated with the new H1N1 vaccine (National Center for~     Immunization). Currently no information exists about the nature of the immune response to~     the vaccine against H1N1 swine-origin influenza virus (S-OIV) in HIV infected children. It~     is unknown whether HIV impairs the immunogenicity of the vaccine predisposing this~     population to infection with S-OIV. Thus, a pilot proposal is being undertaken to study the~     mechanism of H1N1 vaccine protection in HIV infected children, by investigating the~     correlation of infection status with seroresponse, duration of response and development of~     influenza-like illness following vaccine. Additionally we will establish whether we can~     identify immune signatures by characteristic gene expression patterns correlating with the~     vaccine immunogenicity that can be predictive of efficacy for good and suboptimal~     vaccination regimen. Data generated will be used to initiate a comprehensive study on the~     immunogenicity of the influenza vaccines in HIV-infected children and youth, which is~     critically important to address the health care needs of this vulnerable population.~   "
78349|NCT02031861|"~     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)~     with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate~     essential hypertension.~   "
78350|NCT02031848|"~     By doing this study, researchers hope to learn whether a person's motivation for food is~     different after he or she loses weight, and if imaging techniques such as fMRI can be used~     to predict whether the person will maintain that weight loss over time.~   "
78351|NCT02031835|"~     The purpose of this current prospective study is to assess the effects of body weight~     support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training~     intervention aim at improving: quality of life, walking capability, spasticity, functions in~     every day life, bone mass density and related hematological factors. The examination~     consisted of (1) neurological classification by ASIA standard neurological classification of~     spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified~     Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury~     II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life-~     BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone~     mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue~     consistency by full body DXA scan, (8) skeletal system health associated blood factors~     (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid~     hormone) by hematological tests. The results will be collected and evaluated using~     statistical software (i.e. SPSS).~   "
78352|NCT02031822|"~     Headache is one of the most common reasons for patients to access healthcare. Greater~     occipital nerve (GON) block with local anesthetic and steroid has been described for the~     management of primary headache refractory to conventional treatment. Two ultrasound~     (US)-guided techniques for greater occipital nerve (GON) block have been described for the~     management of refractory headache syndromes: a proximal technique performed at the level of~     the second cervical vertebra and a distal technique performed at the level of the superior~     nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two~     techniques in patients with refractory headaches.~   "
78353|NCT02031809|"~     This study investigates the most common major complications that result in unplanned~     additional surgery in patients undergoing vats anatomical resections. Several high-volume~     European centres participate. The purpose is to quantify these major complications, discuss~     the steps that can be taken to prevent these events, how they can be dealt with, be it by~     vats or conversion~   "
78354|NCT02031796|"~     The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular~     Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm~     for use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the~     same x-ray projection images as currently acquired for clinical DynaCT. X-ray image~     acquisition to allow CAVAREC will occur during the TAVI procedure and after the TAVI device~     is implanted. If you already have a surgically-implanted TAVI device and are having a~     cardiac catheterization, then an extra set of images will be acquired after your clinical~     care is complete, but before you leave the procedure room. The CAVAREC image processing~     algorithm will be implemented on an off-line workstation after the TAVI procedure is~     complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively~     compared to Siemens DynaCT and cardiac CT images from Radiology. The results of this study~     will be used to direct further development of CAVAREC toward the end goal of providing~     improved imaging capabilities to guide TAVI procedures.~   "
78355|NCT02031783|"~     The primary objective is to show that multiple transportable carbohydrate ingestion is more~     effective in improving endurance performance compared to single transportable carbohydrate~     ingestion.~   "
78356|NCT02031770|"~     Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney~     disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic~     acidosis is a common complication of CKD resulting from an inability of the diseased kidney~     to excrete the daily dietary acid load and it is associated with all-cause mortality in~     patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium~     bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not~     been evaluated. The investigators propose a prospective, randomized, controlled, open-label~     14-week crossover pilot study examining the effect of treatment of metabolic acidosis with~     oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV~     with metabolic acidosis.~   "
78357|NCT02031757|"~     Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease,~     injury and surgery. One of the consequences of such deficit is an increased risk of fall and~     injury. A gait training regime that incorporates controlled perturbation has been found to~     reduce falls in elderly population but the effectiveness of such training has yet to be~     studied.~      The aim of this study is to evaluate the effectiveness of specific controlled dynamic~     perturbation training, during gait, on gait rehabilitation, fear of falling and falling with~     gait impaired individuals. Perturbation will be performed using a specifically designed~     system that provides small, controlled and unpredictable perturbations during treadmill~     walking.~   "
78358|NCT02031744|"~     This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety~     and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with~     treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung~     cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb +~     Tarceva or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb~     (15 mg/kg) will be given intravenously every 3 weeks. Treatment will continue until disease~     progression, unacceptable toxicity, a decision to discontinue, or death occurs. Total study~     length is expected to be around 36 months.~   "
78359|NCT02031731|"~     This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in~     chinese patients with locally advanced or metastatic solid tumors. Patients will be divided~     into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be~     treated sequentially, starting with the lowest dose. MetMAb will be administered~     intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1~     year, whichever occurs first, in the absence of disease progression.~   "
78360|NCT02031718|"~     This study will develop and evaluate the efficacy of an Internet-based education program~     incorporating virtual coaching. For this study, the virtual coach will consist of online~     videos aimed at providing acne education and promoting behaviors that support healthy skin.~     The use of Web-based technologies and virtual coaching in acne-related patient education is~     novel, and may significantly improve clinical outcomes and quality of life in acne patients.~     We hypothesize that an interactive Internet-based education and counseling program will be~     more effective than Internet-based education alone in improving clinical outcomes and~     quality of life in acne patients.~   "
78361|NCT02031705|"~     It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in~     preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus~     ablation on atrial fibrillation itself is unclear.~   "
78362|NCT02031692|"~     The purpose of this study is to determine whether the supplementation of vitamin D and~     calcium prevents recurrences of benign paroxysmal positional vertigo in patients with~     vitamin D deficiency/insufficiency.~   "
78363|NCT02031679|"~     We are recruiting for a chronic hives study. This research is being done to test whether an~     investigational drug called AZD1981 may be helpful for treating people with Chronic~     Idiopathic Urticaria who continue to have symptoms despite taking antihistamines. The word~     investigational means that AZD1981 is not approved for marketing by the Food and Drug~     Administration (FDA). The FDA is allowing the use of AZD1981 in this study.~      People with chronic hives lasting for at least 6 months and without a known cause may join.~     The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take~     part in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be~     treated with the study medication and/or placebo for 8 weeks.~      The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who~     don't respond well to antihistamines by generating experience and data to support the design~     of a larger, multicenter trial investigating the efficacy of AZD1981 in treating~     antihistamine refractory CIU.~   "
78364|NCT02031666|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and relative bioavailability (the extent to which a medication or other~     substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet~     formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927~     in healthy male participants under fasted conditions at a single dose of 240 mg.~   "
80782|NCT02000063|"~     A single long-term follow up assessment of an established multi-centre, prospective~     longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes~     4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.~   "
78365|NCT02031653|"~     To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction~     (BOO) in men with benign prostatic hyperplasia.~        1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level~          of accuracy without the morbidity and expense of invasive Pressure flow study.~        2. Penile cuff test may be particularly useful in the counseling of patients prior to~          benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a~          penile cuff test can be reassured that surgery has a high chance of resulting in~          symptomatic benefit~   "
78366|NCT02031640|"~     This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy,~     parallel-group, 12-week study in male and female patients, 12 years of age and older, with~     persistent asthma.~   "
78367|NCT02031627|"~     Proof of principle study in order to determine if there is a difference in treatment effect~     across the 3 study groups when treating lower extremity lymphoedema using a pneumatic~     compression device.~   "
78368|NCT02031614|"~     Although phlebotomy is routinely performed in blood donors, and seemingly does not have~     significant health risks, it is highly relevant to know what the effect of phlebotomy is on~     immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the~     suppression of the low grade inflammatory process that contributes to atherosclerosis, but~     in theory could also contribute to a suppressed innate immune response that could increase~     the risk of infection. This is not only relevant for blood donors, but also for patients~     suffering from blood loss and for daily clinical practice in which blood is routinely drawn~     of patients for laboratory determinations.~   "
78369|NCT02031601|"~     Objective: To compare the efficacy and safety of chemotherapy plus intercalated~     EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as~     first-line treatment for patients with non-small-cell lung cancer (NSCLC).~      Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be~     randomly assigned to combination therapy group (receiving four cycles of docetaxel or~     pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib~     or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or~     Icotinib, daily). All patients were continued to receive TKI until progression or~     unacceptable to toxicity or death. The primary endpoint was progression-free survivial~     (PFS).~      Expected results: PFS of combination therapy group will be prolonged to nineteen months~     while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination~     therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26~     months.~      Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as~     first-line treatment will prolong PFS and OS for patients with NSCLC.~   "
78370|NCT02031588|"~     Observational study of the effects of antibiotics on commensal flora. Realization of stool~     samples and nasal swabs before and after antibiotic therapy.~   "
78371|NCT02031575|"~     The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate~     the effectiveness of using text messages to improve the knowledge, communication, and~     attitudes about reproductive health among female adolescents in Greater Accra senior high~     schools. Previous research as well as qualitative work conducted by the Investigators shows~     that there are significant gaps in knowledge about reproductive health including on topics~     of pregnancy, sexually transmitted diseases, and contraception among secondary school~     students in Greater Accra. These gaps contribute to unwanted pregnancy and spread of~     sexually transmitted diseases. At the same time, phone ownership and use among young people~     has spread rapidly, especially in urban areas such as Accra. The Study on Mhealth and~     Reproductive Health (SMART) will seek to use mobile phone messages to increase awareness of~     these reproductive health issues among female adolescents in Accra. The objectives of SMART~     are to evaluate whether the messages can increase knowledge, increase communication, and~     improve attitudes towards reproductive health among adolescents in Greater Accra. By~     conducting a randomized controlled trial, we will be able to statistically evaluate if the~     messages have had any effect on improving outcomes for adolescents in the areas of~     knowledge, communication, and attitudes. This work can help guide future programs that can~     scale up this intervention and ultimately improve the health and wellbeing of adolescents~     across Ghana.~   "
78372|NCT02031562|"~     This study evaluates the effect of standard of care treatments (physical therapy versus~     manual therapy) in older adult patients who have balance problems with or without low back~     pain.~   "
78373|NCT02031549|"~     We will investigate potential correlation between SpermComet DNA fragmentation assay results~     and IVF cycle outcome.~   "
78374|NCT02031536|"~     This randomized phase II trial studies how well everolimus works in treating patients with~     pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving everolimus after surgery may kill any tumors cells that remain.~   "
78375|NCT02031523|"~     It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in~     Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in~     the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.~   "
78376|NCT02031510|"~     The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block~     will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.~   "
78377|NCT02031497|"~     The purpose of this study is to determine whether consumption of carbonated drinks~     containing sweeteners affect insulin sensitivity.~   "
78378|NCT02031484|"~     This study is intended to compare the new Carnation patch monitoring system with the Zio~     patch, which represents the current standard for continuous recording of the ECG over~     extended periods.~   "
78379|NCT02031471|"~     This open-label, single-arm study will evaluate the efficacy, safety and tolerability of~     subcutaneously administered tocilizumab in monotherapy and/or in combination with~     methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in~     participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab.~     Participants will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks.~     Participants who complete the core study achieving at least a moderate European League~     Against Rheumatism (EULAR) response at Week 24 may enter the extension phase and receive for~     a further 28 weeks at the most.~   "
78380|NCT02031458|"~     This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in~     patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer.~     Patients will receive Atezolizumab 1200 mg intravenously every 3 weeks as long as patients~     are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of~     unacceptable toxicity or symptomatic deterioration attributed to disease progression.~   "
78381|NCT02031445|"~     Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and~     safety study in subjects with mild to moderate atopic dermatitis.~      Following the double blind period, subjects will be allowed to continue treatment with~     topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream~     2% compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and~     demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of~     atopic dermatitis.~   "
78382|NCT02031432|"~     The purpose of this trial is to find out how well cebranopadol is tolerated and how often,~     and which, adverse reactions occur when it is taken every day for a longer period of time.~     In addition information will be collected how cebranopadol affects pain and well-being in~     patients suffering from cancer-related pain.~   "
78383|NCT02031419|"~     First study, at multiple clinical centers, exploring the effects of different combinations~     of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma~     (DLBCL)~   "
78384|NCT02031406|"~     A significant portion of avoidable healthcare expenditures has been attributed to~     preventable hospital readmissions; thus, reducing hospital readmission rates has become a~     national healthcare agenda item. Despite much study of this topic, efforts to date have not~     been especially fruitful in either predicting which patients will require hospital~     readmission. Preventing readmissions has been even more difficult.~      We recently examined a pharmacist intervention that assessed patients' medication literacy~     and adherence at hospital admission. In this retrospective data, low medication adherence~     levels were predictive of hospital readmission. There was a non-significant trend between~     low medication literacy and increased hospital readmissions.~      We have now decided to prospectively study this intervention. Prospective study will allow~     for several improvements on our prior work.~        1. We have consulted the literature to more carefully examine existing instruments to~          measure medication adherence and literacy. Based on this review, and based on our prior~          results, we have made adjustments to these instruments which should improve~          reliability, validity, and granularity.~        2. In our retrospective work, our intervention of pharmacist counseling was not~          randomized. Although there were large differences in readmission rates between the~          patients selected to receive counseling and those who were not thought to require it,~          there may have been unmeasured confounding variables. Randomizing this intervention~          will greatly enhance the likelihood that we are comparing two similar groups of~          patients.~   "
78385|NCT02031393|"~     The purpose of this study is to determine whether we can establish different markers suc as~     mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood~     and more un the first trimester, in order to screen for twin pregnancies that are more~     likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.~   "
78386|NCT02031380|"~     The purpose of this study is to evaluate the usability of a medication management support~     system for glaucoma patients self-administering eye drops named iDropper. The iDropper~     system is a home-based ocular medication management system that reminds, instructs,~     dispenses, and records eye drop medication usage. The iDropper system will be evaluated~     among a cohort of glaucoma subjects self-administering eye drops for 4-weeks.~   "
78387|NCT02031367|"~     The object of this study is to compare the effect of PRP versus Corticosteroid injection on~     pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It~     is believed that PRP will be as good as corticosteroids for short term pain relief, and will~     produce longer lasting pain reduction.~   "
78388|NCT02031354|"~     The purpose of this study is to determine if administration of supplemental chloride in the~     form of lysine chloride to patients with congestive heart failure will affect their~     neurohormonal profile as well as response to diuretics.~   "
78389|NCT02031341|"~     Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus.~     It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle~     interstitium plays a role in this process.~      We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle~     interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes~     mellitus.~   "
78390|NCT02031328|"~     You have been asked to consider participating in the study because you have a cancer of the~     prostate, which is to be treated with external beam radiation. You have chosen or felt not~     to be a good candidate for just watching your cancer. As your doctor has informed you, this~     involves delivering small amounts of radiation daily over several weeks. Normally, a small~     field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of~     radiation are delivered. There is now growing evidence that prostate cancer cells may be~     killed more effectively if higher doses of radiation are delivered everyday (known as~     hypofractionation). However, the downside to such a strategy is the potential to cause more~     side effects because normal organs (such as the rectum and bladder) are also exposed to the~     higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which~     has the ability to deliver radiation in a more focused manor, meaning that the radiation~     dose can be sculpted to the prostate gland, while minimizing the amount of radiation to~     the bladder and rectum.~      A certain amount of movement of the prostate normally occurs within the body. To make sure~     that the prostate will not be missed, a margin of tissue around the prostate also needs to~     be treated. Although a wide margin will ensure that the prostate is included, it will also~     cause more normal tissue to receive high doses of radiation. This, in turn, would result in~     more side effects. To reduce the margin needed around the prostate, and side effects, tiny~     gold seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using~     a special type of X-Ray camera called a portal imager during treatment. This will allow for~     targeting of the prostate gland more precisely so that a significantly smaller margin of~     normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there~     is the potential to safely deliver a more intensive dose of radiation to the prostate gland~     without increasing the amount of side effects.~      In other studies where shorter and more intense courses of radiation have been given using~     similar high-precision techniques, the side effects of treatment have indeed been no worse~     than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over~     three hundred prostate cancer patients on various research protocols with SABR. In those~     protocols, patients received 5 SBRT treatments over 29 days and this is currently being~     compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United~     States, several groups have investigated the 5 SBRT approach in 11 days or less and early~     findings suggest a good tolerance.~      The study is being done to determine the side effects, quality of life and efficacy of~     2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk~     prostate cancer. All participants will receive the same dose and fractionation scheme.~   "
78941|NCT02024139|"~     This study investigates whether chewing sugar-free chewing gum can reduce pain associated~     with braces treatment. The study collects pain scale records for 10 consecutive days after~     placement of braces. No changes to patients routine braces treatment is done. All materials~     used are available over the counter.~   "
78391|NCT02031315|"~     Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to~     assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country.~     Methods The Douala-SD study is a prospective, multicenter, community-based registry~     monitoring all cases of SD occurring in index areas of Douala city. Investigators will use~     the definition of SD as natural death occurring within 24h at the onset of symptoms.~     Demographic, clinical, electrocardiographic and biological variables (when available) of~     victims will be recorded. All deaths occurring in residents of health areas of interest will~     be checked for past medical history, circumstances of death, and autopsy (if possible).~     Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the~     epidemiology of SD in a sub-Saharan African country and will help in the development of~     strategies to prevent and manage SD in Africa.~   "
78392|NCT02031302|"~     The purpose of the RESPOND post market study is to collect real world clinical and device~     performance outcomes data with the Lotus Valve System used in routine clinical practice to~     demonstrate that the commercially available Lotus Valve System is a safe and effective~     treatment for patients with severe calcific aortic stenosis.~   "
78393|NCT02031289|"~     We are performing the above prospective randomized trial in 1'000 patients undergoing~     cardiac surgery. The study will answer the question of whether preoperative treatment of~     anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important~     clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The~     list of inclusion and exclusion criteria was deliberately chosen short so that this patient~     group largely reflects today's clinical practice .~        -  Trial with medical product~   "
78394|NCT02031276|"~     This study is a proof of concept, multi-center, randomized, double-blind,~     placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066~     (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to~     severely active Crohn's disease.~   "
78395|NCT02031263|"~     The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute~     exacerbation and improving quality of life for uncontrolled asthma in Korea through this~     research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was~     performed in Western countries.~      Korean FDA have approved this procedure in 2013. However, no procedure was performed in~     Korea, and the data is rare in Asian countries. In this study, investigators will examine~     the efficacy of this procedure in Korean asthmatics.~   "
78396|NCT02031250|"~     This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC)~     patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be~     resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced~     Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and~     surrounding normal tissues will be maintained.~   "
78397|NCT02031237|"~     This study aims to assess changes in vascular permeability in the brain tumor, and in the~     surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).~   "
78398|NCT02031224|"~     This is a prospective single center randomized controlled trial with a total duration of 18~     months aiming to evaluate the effectiveness and the safety of a very low protein diet~     supplemented with ketoanalogues of essential aminoacids in reducing the progression of~     chronic kidney disease (CKD) in patients with advanced CKD.~   "
78399|NCT02031211|"~     Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic~     Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient~     symptoms if given in early CRPS.~   "
78400|NCT02031198|"~     This follow-up study continues to observe patients who have completed the phase 1 trial of~     AADvac1, for another 18 months.~      Long-term safety and behavior of the immune response to AADvac1 over time are the main~     points of interest.~      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is~     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a~     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.~      As this study is a Phase I study focused on tolerability and safety, efficacy will be~     assessed in an exploratory manner.~   "
78401|NCT02031185|"~     Due to disparities in childhood obesity, interventions for physical activity promotion and~     obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents~     are vital to address disparities across the lifespan. Mobile health applications (mHealth~     apps) are a rapidly growing and promising approach for interactive and individualized~     interventions for disease prevention. Smart phones are a promising platform to reach~     racial/ethnic minority and lower income groups due to high rates of adoption of smart phone~     usage among these groups When paired with wearable sensing devices, mHealth apps for smart~     phones can collect data and provide feedback to users in real time. In a study among~     university students regarding mHealth apps, participants expressed interest in the ability~     to record and track behaviors and goals and the ability to acquire advice and information~     'on the go'. For physical activity in particular, wearable physical activity monitors~     designed for consumers that objectively measure and display data related to an individual's~     physical activity on smart phones through mHealth apps have become widely available and~     affordable. These wearable devices wirelessly upload data and provide users with physical~     activity data visualization and goal setting features that can be customized for each user~     via internet-based applications for smart phones, tablets, and/or computers. While several~     internet-based behavioral programs to promote pediatric physical activity have been reported~     in a recent review, none examined wearable sensing devices coupled with mHealth apps.~     Similarly, a 2013 review on mHealth technologies for physical activity assessment and~     promotion reported no studies that used wearable sensing devices for intervention delivery~     and called for research to evaluate feasibility.~      The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex,~     a popular wearable physical activity sensing device that allows data visualization and goal~     setting on smart phones. The target population will be adolescents ages 14-18 years old in~     the Seattle-metro area (n=40) with approximately 50% from low income households or belonging~     to a racial/ethnic minority. We will target this older age group since they have the lowest~     levels of physical activity among the pediatric population. This pilot study will provide~     feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and~     app.~   "
78402|NCT02031172|"~     This research is being done to to see if changes in visual reading function correlate with~     changes in optical and retinal image quality. We hypothesize that changes and deterioration~     in tear film quality and dynamics may have a negative effect on reading function.~      People with or without dry eye syndrome may enroll.~   "
78403|NCT02031159|"~     Hypothermia is common in patients undergoing general anesthesia. There have been several~     negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body~     core temperature. The aim of this study is to see if this method is comparable in terms of~     correlation, accuracy, precision and practicability to commonly used sublingual and~     nasopharyngeal temperature monitoring.~   "
81482|NCT01990885|"~     The purpose of this study is to evaluate the safety of different amounts of BL-7010 in~     single oral administration and in repeated oral administration to well-controlled celiac~     patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.~   "
78404|NCT02031146|"~     Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system~     in about 40% of patients with syphilis. This happens early after infection. Patients with~     neuroinvasion are at risk of developing serious neurological complications, including vision~     or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the~     only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal~     fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of~     immediate LP, followed by therapy based on CSF evaluation, results in better serological and~     functional outcomes in patients with syphilis who are at high risk for neuroinvasion.~   "
78405|NCT02031133|"~     Study SPC3649-207E is designed as an extension study to the prior protocol to provide~     additional long-term safety and efficacy information for subjects participating in Study~     SPC3649-207.~   "
78406|NCT02031120|"~     The aim of this study is (1) to assess the incidence of suspected drug allergies in a~     pediatric hospital and the proportion in which these reactions are confirmed to be allergic;~     (2) to evaluate the diagnostic values of the different allergy tests available; (3) to~     investigate the pathophysiology of drug allergies, particularly by investigating the role of~     viruses, and by performing HLA typing and a gene expression profile both in the acute phase~     of the reaction and 2 months later.~   "
78407|NCT02031107|"~     Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation~     can induce significant and sustained improvements in functional outcome. However the effect~     is inconsistent and difficult to predict, in particular in the subacute phase after stroke.~     Although several different stimulation techniques are available, it is unknown which is~     suitable for which patient.~      Objectives: This study has three main objectives:~        1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC,~          continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on~          clinical recovery in patients with subacute stroke.~        2. To assess the effect of these brain stimulation techniques on brain organization with~          non-invasive imaging.~        3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.~      Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of~     3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding~     stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical~     therapy. Before and after the treatment period, standardized assessments of sensorimotor~     function areas are obtained together with electroencephalography and functional magnetic~     resonance recordings. These recordings will be used to analyze and compare the neural~     effects of each treatment modality.~      Clinical Implication: The results of this study might help optimize and individualize~     stimulation treatment for patients with subacute stroke. It may hence facilitate the~     transfer of brain stimulation therapy to routine clinical practice.~   "
78408|NCT02031094|"~     This observational study will measure resting energy expenditure in patients who have~     undergone liver resection and compare methods of measuring resting energy expenditure.~   "
78409|NCT02031081|"~     The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort~     include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis~     slows digestion, it can lead to malnutrition and make controlling blood sugar even more~     challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and~     lifestyle modifications but treatments for more severe symptoms are limited. There are~     several drugs called pro-kinetics available in Canada though results vary among patients and~     these often cause significant side effects. Recently, a drug called Prucalopride was~     approved for use in Canada to treat constipation. It has pro-kinetic properties and has been~     shown to cause few side effects. The investigators propose to test prucalopride as a~     treatment for gastroparesis by recruiting 30 patients from the Calgary area who have~     gastroparesis. The investigators will test the effects of this treatment by alternating 28~     days of active treatment with prucalopride with 28 days of treatment with a non active~     placebo adding a two week break in between treatments. The order of the treatment will be~     randomized and neither the patients nor the investigators will know whether they are~     receiving the active treatment or the placebo until the study has been completely finished.~     The investigators will measure the effects using questionnaires that assess patient symptoms~     such as nausea and pain as well as quality of life during two gastric emptying tests and~     throughout the treatment periods. The effectiveness of the active treatment will be~     evaluated by comparing the extent of the change in symptoms before and after treatments and~     the difference in gastric emptying times as compared to the placebo treatment. The~     investigators will also monitor and track all possible side effects that patients experience~     during the study.~      Study Hypotheses~      In patients with gastroparesis:~        1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined~          by the change in cumulative meal-related symptoms. (primary endpoint).~        2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo.~          (secondary endpoint).~        3. A correlation exists between the effect of prucalopride on gastric emptying rate and~          symptom improvement.~   "
78410|NCT02031068|"~     To test the safety and feasibility of a new treatment for adolescents who are slow to~     recover from a sport-related concussion, the investigators are conducting a randomised~     controlled trial comparing treatment as usual with an active rehabilitation program that~     involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and~     positive visualisation techniques.~   "
78411|NCT02031055|"~     The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass~     balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD~     or [14C]TPI.~   "
78412|NCT02031042|"~     The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable~     staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast~     surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the~     sentinel lymph node is free of metastasis.~   "
78413|NCT02031029|"~     It has previously been reported that men with prostate cancer are 1 ) reduced quality of~     life after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related~     to treatment side effects, and 3) often have very involved and active spouses who seems to~     have been handed over / taken over parts of the men's responsibility for their own health.~     We postulate herein a new hypothesis that the stress level is elevated when harbouring~     undetected prostate cancer. We will investigate whether those who are diagnosed with~     prostate cancer already in beforehand have an increased degree of masculine stress (~     experience of not living up to their own perception of the ideal man ) and neuroticism in~     the typology. We will examine different personality and QoL questionnaires for patients with~     elevated PSA, and compare those whose clinical assessment later reveals prostate cancer,~     with three control groups: 1) men with elevated PSA who are not diagnosed with prostate~     cancer, 2) men with normal PSA treated for benign prostate enlargement and 3) patient with~     substantial risk of colorectal cancer (CRC) who undergo colonoscopy, with regard to~     increased level of masculine stress and the personality trait neuroticism.~   "
81516|NCT01990443|"~     The primary objective of this study is to assess the absolute bioavailability of reslizumab~     following administration of a single subcutaneous (sc) dose to healthy non-Japanese~     participants~   "
78414|NCT02031016|"~     This study will investigate the influence of intra-operative use of remifentanil versus~     fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via~     sternotomy. Secondary quantitative sensory testing is performed to determine thermal and~     electrical detection and pain threshold and the difference in pain variability scoring.~     Postoperative pain scores, analgesic use, genetic variances and costs are measured.~   "
78415|NCT02031003|"~     -  The primary objective of the study was to compare stool composition (stool soap and~          non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of~          infants randomized to receive either standard formula, or 1 of 2 innovative formulas~          containing a new fat blend or the new fat blend plus fiber.~        -  The secondary objectives were to evaluate among the feeding groups, stool~          characteristics (stool consistency and frequency), GI tolerance assessed by the Infant~          Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and~          8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).~        -  The primary safety objective was to describe the frequency of adverse events (AEs)~          among the formula-fed (FF) groups.~        -  The secondary safety objective was to describe anthropometric measures (weight, length,~          and head circumference) among the feeding groups.~   "
78416|NCT02030990|"~     1. Purpose To evaluate the use of mitomycin-C (MMC) as an intraoperative adjunct during~          photorefractive keratectomy (PRK), its effect on postoperative healing and its ability~          to reduce the postoperative topical steroid course after the surgery.~        2. Research Design This is a single-center, prospective, comparative cohort study.~        3. Hypothesis There will not be a significant difference in the refractive corrections~          amongst the treatment groups, 12 months after surgery.~        4. Objectives The primary study objective is to compare the effect of intraoperative MMC~          and a postoperative short topical steroid taper of 3 weeks, intraoperative MMC and a~          rapid topical steroid taper of 1 week, and a more commonly accepted postoperative~          regimen of a 2 month long topical steroid taper without any intraoperative MMC. The~          primary endpoint evaluated will be objective estimates of refractive error (WaveScan~          WaveFront™ System) at 12 months post-surgery. Secondarily, the extent of haze formation~          will be evaluated objectively using densitometry maps generated by automated~          Scheimpflug imaging of the cornea (Pentacam®). Furthermore, the subjective vision from~          the patients' perspective will be evaluated by questionnaires.~   "
78417|NCT02030977|"~     To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients~     who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly~     allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be~     advised to adherence our diet and exercise program too. At the first and the end of the~     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis~     will be assessed and compared between groups.~   "
78418|NCT02030964|"~     This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV~     chemotherapy medicines called cyclophosphamide and topotecan.~        -  To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and~          topotecan without causing severe side effects.~        -  To find out the side effects seen by giving DFMO at different dose levels with~          celecoxib, cyclophosphamide and topotecan.~        -  To measure the levels of DFMO in the blood at different dose levels.~        -  To determine if your tumor gets smaller after treatment with DFMO, celecoxib,~          cyclophosphamide and topotecan.~        -  To determine if specific gene changes in you or your tumor makes you more prone to side~          effects or affects your tumor's response to the combination of DFMO, celecoxib,~          cyclophosphamide and topotecan.~        -  To determine if the amount of normal chemicals in your body called polyamines go down~          in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are~          more likely to have a good response to the treatment if they do.~   "
78419|NCT02030951|"~     Feeding that circumvents the oral cavity drastically alters the infant's feeding experience~     (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that~     35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral~     feeding, growth failure, and inadequate mother-infant interaction. Behaviors related to the~     feeding experience include behavioral state transitions, orally directed behaviors, hunger~     and satiation cues, and social interactive behaviors. It is unknown whether these early~     behaviors differ for hospitalized infants who receive long term tube feedings when compared~     with infants fed orally or whether alterations in these behaviors can be early indicators of~     later oral feeding difficulty. Documentation of these missing or altered behaviors is needed~     prior to the development and testing of interventions to prevent oral feeding difficulty.~      For 75 hospitalized infants with long term tube feedings, this research will: 1) describe~     the range of early feeding behaviors encompassing the feeding experience; 2) identify the~     change in early feeding behaviors throughout hospitalization; 3) compare the early feeding~     behaviors of infants with and without oral feeding difficulty at 12 months corrected age~     (CA); and 4) compare parent perception and provider assessment of feeding, for infants with~     and without oral feeding difficulty.~      We will document infant behaviors surrounding the feeding experience during tube feedings~     weekly during hospital stay. Throughout the first year of life, infant growth, parent~     perception and clinician assessment of infant feeding and infant and maternal behavior~     during feeding will be evaluated to document the occurrence of oral feeding difficulty,~     allowing for a comparison with early in hospital feeding behaviors. To analyze for changes~     over time, we will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson)~     and frequency/categorical (logistic and multinomial logistic) outcomes (e.g., frequency of~     infant behaviors). Understanding the constellation of these behaviors and when they begin,~     will guide the development of interventions whose goal will be to alleviate the long term~     consequences of oral feeding difficulty, inform clinical practice, and reduce cost.~   "
78420|NCT02030938|"~     An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support~     in subjects undergoing revision augmentation surgery for increased nipple to inframammary~     fold distance.~   "
78421|NCT02030925|"~     This study is meant to assess the effect of IW-3718 as an added treatment to ongoing~     once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience~     symptoms of their gastroesophageal reflux disease (GERD).~   "
78466|NCT02030340|"~     Various systems to measure intravesical and intrarectal pressure during urodynamic testing;~     especially cystometry, exist. Water filled tube -systems are the most commonly used and~     should be regarded as the contemporary standard. A water filled system is however sensitive~     to tube and or patient movement artefacts and prone to erroneous calibration. Air charged~     catheters are less sensitive to patient and especially tubing- movements, and calibrate~     easier. However, in vitro tests have demonstrated that air charged catheters respond~     somewhat slower and relatively damped, especially to rapid pressure changes as in~     (simulated) coughing, in comparison with water filled systems. The clinical relevance of~     these observations is unknown.~      This is a study to compare the technical reliability and clinical applicability of the two~     types of catheter systems for cystometry in a synchronous double catheter testing procedure~     in a prospective group or patients scheduled for urodynamic investigation.~   "
78422|NCT02030912|"~     A randomised, open labelled study design is selected in order to determine the emergence and~     persistence of antibiotic resistant bacteria in humans and on the composition of the~     indigenous microbiotas at various body sites. These will involve the administration to~     volunteers of minocycline and amoxicillin- a control group will receive a placebo.~     Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse~     events, vital signs, will be evaluated. The objectives of metagenomic analysis are:~        -  To identify the in vivo molecular mechanisms responsible for antibiotic resistance and~          its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome~          analysis.~        -  To determine the impact of the use of antimicrobial agents on the oral resistome~        -  To determine the impact of the use of antimicrobial agents on the faecal resistome~        -  To determine the ecological impact of the use of antimicrobial agents on the relative~          abundance of phylotypes of the indigenous oral microbiota~        -  To determine the ecological impact of the use of antimicrobial agents on the relative~          abundance of phylotypes of the indigenous faecal microbiotas~   "
78423|NCT02030899|"~     The use of plate in addition to autologous bone is better then stand alone cage fusion~     regarding fusion rate and segmental lordosis.~   "
78424|NCT02030886|"~     The purpose of the study is to assess the relationship between IOP pattern as recorded over~     24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and~     conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal~     range is called ocular hypertension (OHT). In a previous study, it has been shown that OHT~     patients who progress to glaucoma (converters) have at baseline and prior to any conversion,~     IOP patterns that more closely resemble those of established early primary open-angle~     glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns~     closer to those of healthy control subjects. The study has been planned to recruit at least~     48 eligible patients (24 converters and 24 non-converters).~   "
78425|NCT02030873|"~     The purpose of this study is to investigate the effect of virtual simulation training on~     mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance~     assessment using a final-product analysis approach and to explore the role of cognitive~     load.~   "
78426|NCT02030860|"~     This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol~     to target the microenvironment in resectable pancreatic cancer to determine the effect of~     targeting the vitamin D metabolic program in the tumors of patients treated with one cycle~     of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable~     pancreatic cancer through an assessment of cellular and imaging markers.~   "
78427|NCT02030847|"~     This is a single center, single arm, open-label phase II study to determine the efficacy and~     safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors~     expressing tandem TCR and 4-1BB (TCR/4-1BB) co-stimulatory domains (referred to as CART-19~     cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~     Inclusion criteria are designed to include adult patients aged greater than 18 with B cell~     ALL, relapsed or refractory, with no available curative treatment options (such as~     autologous or allogeneic stem cell transplantation) who have limited prognosis (greater than~     12 weeks survival expectancy) with currently available therapies. The study product is~     CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB~     administered by a single i.v. infusion of 1 to 5 x 108 transduced CAR T cells.~   "
78428|NCT02030834|"~     Phase IIa study to estimate the efficacy of a single infusion of autologous T cells~     expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB)~     costimulatory domains (referred to as CART-19 or CTL019 cells) in non-Hodgkins Lymphoma~     (NHL) patients. The duration of active protocol intervention is approximately 24 months from~     screening visit. The protocol will require approximately 48 months to complete.~   "
78429|NCT02030821|"~     The purpose of this study is to determine the relative effectiveness of two drug agents,~     Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism~     of action. These agents are used to decrease blood loss that is a result of major surgery,~     like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of~     total hospitalization. Both TXA and Amicar are both currently used in the care of patients~     undergoing total joint arthroplasty.~      Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study~     including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit~     and hemoglobin, and complications will be collected during the hospitalization stay.~      Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing~     intraoperative blood loss and the need for transfusion post-op than Amicar.~      A detailed cost analysis will show that the overall cost of performing the operative~     procedure, including transfusions, OR time, and total costs associated with admission cost~     will be more decreased with Amicar as compared to TXA.~   "
78430|NCT02030808|"~     Although the administration of muscle relaxation is essential standard of care for thoracic~     procedures, it could cause long-reversal times and postoperative residual curarization~     (PORC) increasing length of post-anesthesia care unit (PACU) stay and hospital costs.~     Sugammadex offers new perspectives to reduce the incidence of PORC. Unfortunately it is not~     available in many countries because of its significantly high cost. We hypothesized that the~     use of target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR)~     would be associated with comparable surgical conditions and reduced total costs compared~     with the use of neuromuscular blockers during thoracotomy.~      After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane~     anesthesia with TCI remifentanil will be included in this prospective, randomized,~     single-blind, controlled study.~      Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each~     group) throughout the procedure. Laryngoscopy and intubating conditions, intraoperative~     modified thoracic surgery rating scale (Table below), incidence of light anesthesia, and use~     of vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital~     stays, and total costs will be recorded.~   "
78467|NCT02030327|"~     To analyse differences in protein expression in multiple trauma patients for identification~     of potential biomarkers to predict organ dysfunction.~   "
81532|NCT01990235|"~     The objective of this proposal is to test whether a multi-media website~     (www.prepareforyourcare.org) that is focused on preparing older adults for communication and~     medical decision making can help people engage in advance care planning.~   "
78431|NCT02030795|"~     The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance~     during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the~     operative lung especially in patients with chronic obstructive lung disease (COPD). The use~     of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung~     collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected~     secretions contaminating the dependent lung.~      We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin~     syringe attached to the suction port of the bronchial blocker would be associated with~     comparable time to optimum lung collapse with the disconnection technique.~      After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective~     VATS using Arndt blocker® for lung separation will be included in this prospective,~     randomized, double-blind study.~      Patients will be randomly assigned to deflate the blocker with either disconnecting the~     endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker~     allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of~     the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).~   "
78432|NCT02030782|"~     This randomized effectiveness trial evaluates a quality improvement intervention aimed at~     providing access to evidence-based depression treatments (particularly cognitive-behavior~     therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as~     compared to enhanced usual care. The major hypothesis is that the quality improvement~     intervention will be associated with improved outcomes, relative to enhanced usual care.~   "
78433|NCT02030769|"~     Lugol's solution staining was regarded as a gold standard to detect early superficial lesion~     during esophageal cancer screening using endoscopy. However, the sensitivity and specificity~     were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was~     previously shown to improve the visibility of gastrointestinal tract. It's unknown if the~     pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A~     randomized double-blind clinical trial was designed to investigate whether or not pronase~     might improve detection rate of early esophageal lesion, especially high grade dysplasia and~     early cancer by improving the esophageal visibility.~   "
78434|NCT02030756|"~     This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus~     sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated~     Individuals~   "
78435|NCT02030743|"~     The purpose of this study is to determine if training visual attention improves balance and~     mobility, and reduces falls in older adults.~   "
78436|NCT02030730|"~     This study investigates the impact of a Triple P Seminar Series on positive parenting for~     universal prevention of behavioural and emotional difficulties in a general Greek sample of~     parents with children aged 2 to 12. It is predicted that, compared to an attention control~     condition, parents randomised to the Seminar Series will report lower levels of children's~     disruptive and emotional difficulties at post-intervention. At the same time, it is~     postulated that parents will show a decrease in dysfunctional discipline styles, greater~     feelings of self-efficacy as well as lower levels of distress. Lastly, it is hypothesized~     that the effects observed at post-intervention will remain at the 6-month follow-up.~   "
78437|NCT02030717|"~     The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin)~     can be better than epidural anesthesia during and after open surgery for renal cell~     carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced~     and, thus, shorten the hospital stay and rehabilitation of the patients.~   "
78438|NCT02030704|"~     To determine the ability of semi‐automated plaque assessment in cardiac computed tomography~     angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of~     patients at intermediate risk for coronary artery disease (CAD).~   "
78439|NCT02030691|"~     Respiratory distress is the main cause of morbimortality in preterm and term neonates. In~     most of the case, these babies required the use of positive end expiratory pressure (PEEP)~     delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is~     widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation~     (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.~      We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with~     respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these~     devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy~     (NIRS).~   "
78440|NCT02030678|"~     A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic~     breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or~     Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary~     endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or~     4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till~     disease progress or other occurrence of withdrawal standards.~   "
78441|NCT02030665|"~     Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana~     dependence is not fully effective. In the current proposal we are exploring the idea that~     more tailored teaching of coping skills may result in improved outcomes for~     marijuana-dependence than those seen thus far. Participants will be 275 men and women~     meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment~     in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM);~     IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone~     for two weeks prior to treatment, for a weekly period during treatment, for another week~     after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP~     conditions, the information gathered from the pretreatment and during-treatment ES periods~     will provide data for a functional analysis of patients' drug use and urges to use. It is~     hypothesized that IATP conditions will yield significantly better coping skills acquisition~     than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change~     in coping skills will predict better outcomes for the IATP conditions~   "
78643|NCT02028026|"~     The purpose of this study is to determine whether vilazodone is more effective than~     citalopram for the treatment of anxious depression. We will use neuroimaging to see whether~     there are changes in the brains of patients receiving the drug vilazodone that are different~     from those of citalopram. These changes may show that vilazodone affects the brain~     differently than most other kinds of standard antidepressant medications.~   "
78442|NCT02030652|"~     The nasal CPAP (continuous positive airway pressure), is a technique of noninvasive~     ventilation commonly used in neonatal intensive care units, and has recently been used in~     association with nasal intermittent mandatory ventilation (NIPPV - intermittent Nasal~     Positive Pressure Ventilation), which consists of the application of respiratory positive~     pressure cycles during the application of nasal CPAP, resulting in high pharyngeal~     pressures. The NIPPV has advantages over traditional CPAP, including the prevention of~     atelectasis, improved respiratory mechanics and decreased work of breathing in premature~     infants. A refinement of this technique is the use of positive pressure breaths associated~     with nasal CPAP synchronously in relation to the newborn's inspiratory effort (SNIPPV -~     Synchronized Nasal Positive Pressure Ventilation).~      Synchronization allows that the cycles of inspiratory positive pressure provided by the~     ventilator coincide with the inspiratory effort, increasing the system efficacy. The~     Neurally Adjusted Ventilatory Assist (NAVA) is a mode of partial ventilatory support based~     on the use of electrical activity of the diaphragm (Edi) to control the mechanical~     ventilator. The ventilatory assistance starts according to respiratory needs of the patient,~     its use in very low birth weight infants showed an improvement in patient-ventilator~     interaction, even in the presence of leak around the endotracheal tube. This prospective~     randomized, clinical trial aims to evaluate, in preterm infants with gestational age lower~     than 34 weeks with respiratory failure treated with noninvasive ventilatory support, the~     impact of SNIPPV with neural adjustment (NAVA) on success ventilation and the need for~     endotracheal intubation when compared to treatment with traditional CPAP.~   "
78443|NCT02030639|"~     The purpose of this study is to gain an understanding of how the experimental anti-cancer~     drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is~     given as an intravenous infusion. In addition, the study will be carefully monitored to see~     if any side effects occur.~      A radioactive drug is used in this study because it is easier and more accurate to measure~     radioactivity than to use more complicated and less sensitive chemical tests for the drug.~   "
78444|NCT02030626|"~     The present study aims to compare directly the efficacy of two noninvasive neurostimulation~     techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical~     current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.~   "
78445|NCT02030613|"~     The purpose of this study is to determine the optimal dosage of etanercept in patients~     treated for idiopathic juvenile arthritis~   "
78446|NCT02030600|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with~     or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in~     subjects with type 2 diabetes.~   "
78447|NCT02030587|"~     This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA)~     versus image-guided percutaneous radiofrequency ablation (RFA) in treating~     aldosterone-producing adenoma.~      The objectives of this study are to~        1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing~          adenoma.~        2. compare the treatment success rates of LA and RFA during follow-up for primary~          aldosteronism.~   "
78448|NCT02030574|"~     The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for~     approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce~     the size of the cancer in your bladder before surgery and can also help to reduce the chance~     that your bladder cancer will come back (metastasize) in other parts of your body after~     bladder surgery.~      This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose~     of this study is to test the effects, good and bad, of low dose weekly cisplatin and~     gemcitabine.~   "
78449|NCT02030561|"~     This study will determine the safety and efficacy of expanded activated autologous NK cells~     administered after Trastuzumab in patients with HER2-positive breast or gastric cancer. It~     will also provide valuable insights of the role of NK cell infusions in adult solid tumors.~   "
78450|NCT02030548|"~     The aim of the study is to evaluate surgery-related bleeding and mortality in patients~     needing acute coronary artery bypass grafting with or without valve replacement during dual~     antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel,~     Ticagrelor)~   "
78451|NCT02030535|"~     The primary objective of this study is to evaluate the efficacy and safety of orally inhaled~     tiotropium and olodaterol as both a fixed dose combination and a free combination with~     respect to lung function and ECG parameters~   "
78452|NCT02030522|"~     This is a prospective cohort treatment intervention study (n=200) whereby U.S. service~     members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by~     Florida licensed mental health professionals trained in ART. The 3 study aims are to: (i)~     evaluate among U.S. service members and veterans overall, and within specific subgroups, the~     magnitude of change in symptoms of PTSD following treatment with ART; (ii) evaluate the~     sustainability of treatment response with ART; and (iii) evaluate the cost effectiveness of~     ART compared to prolonged exposure (PE) therapy in the treatment of symptoms of PTSD.~   "
78453|NCT02030509|"~     Head and neck cancer would be suitable for quick diagnostic programs because their initial~     symptoms are easy detectable and the curation rates in the initial stages are very high.~      Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages.~      The hypothesis of this study is that a program for quick referral of patients with symptoms~     of head and neck cancer would help early diagnosis.~   "
78468|NCT02030314|"~     Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment~     for kidney transplant patients who have resistant hypertension on multi-drug therapy. We~     will collect initial data on the safety and efficacy of Chlorthalidone in the treatment of~     patients with resistant hypertension.~      To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of~     resistant hypertension among stable kidney transplant recipients~   "
78469|NCT02030301|"~     The purpose of this study is to test the safety and effectiveness of two experimental~     therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).~   "
79530|NCT02016456|"~     This research programme purports to test the effectiveness of two Transcranial Magnetic~     Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in~     reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI)~     scans to improve the localization of TMS targets.~   "
78454|NCT02030496|"~     BACKGROUND:~      Fractures of the distal radius are common and account for an estimated 17% of all fractures~     diagnosed. Two-thirds of these fractures are displaced and require reduction. Although~     distal radius fractures are considered to be relatively harmless, inadequate treatment may~     result in impaired function of the wrist. The consequences of post-traumatic loss of~     function are comprehensive, both on an individual and a social level, and have long been~     underestimated. Despite the substantial implications, no evidence-based treatment method yet~     exists. Good results have been described both in patients treated conservatively and~     surgically. Nevertheless, 60% of all fractures redislocate after conservative treatment at~     which point surgical reduction and fixation is the treatment of choice. Recently, the use of~     volar locking plates has become more popular. This type of osteosynthesis employs a volar~     approach to the wrist and provides immediate stable fixation of the reduced fracture. This~     stability allows for early mobilisation and may therefore result in an improved regain of~     function. The aim of this study is to compare the functional outcome following surgical~     reduction and fixation with a volar locking plate with the functional outcome following~     closed reduction and plaster immobilisation at one year follow-up in patients with displaced~     extra-articular distal radius fractures.~      DESIGN:~      This single blinded randomised controlled trial will randomise between open reduction and~     internal fixation with a volar locking plate (intervention group) and closed reduction~     followed by plaster immobilisation (control group). The study population will consist of all~     consecutive adult patients who are diagnosed with a displaced extra-articular distal radius~     fracture which has been adequately reduced at the Emergency Department. The primary outcome~     (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score~     (DASH). Since the treatment allocated involves a surgical procedure, randomisation status~     will not be blinded. However, the researcher assessing the outcome at one year will be~     unaware of the treatment allocation. In total, 90 patients will be included in this trial~     which will be conducted in the Academic Medical Centre Amsterdam and its partners of the~     regional trauma care network.~   "
78455|NCT02030483|"~     Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991~     (Palbociclib) in combination with lenalidomide will result will be both effectively inducing~     myeloma plasma cell death as well maintaining a favorable side effect profile.~   "
78456|NCT02030470|"~     Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues~     leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for~     periodontal diseases display more or less pronounced persistence of periodontal tissue~     infection, inflammation, and destruction. The therapeutic additional value of photodynamic~     anti-infectious treatment remains controversial. The objective of this study is to evaluate~     the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment~     outcomes and to define its specific therapeutic indications.~   "
78457|NCT02030457|"~     This study is designed to compare the systemic exposure of orally inhaled beclomethasone~     dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.~   "
78458|NCT02030444|"~     The overall aim of this study is to compare standard staging of lung cancer (which includes~     clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which~     includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar~     lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of~     therapy.~   "
78459|NCT02030431|"~     A prospective, randomized study comparing the effectiveness of a new system, Dynaloc~     compared with three cancellous screws, for osteosynthesis of femoral neck fractures~   "
78460|NCT02030418|"~     Prospective, non-randomized, single-arm, international multicenter, clinical safety and~     effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR~     pacemaker.~      Following completion of enrollments in the IDE, patients will continue to be enrolled in the~     continued access phase of the study under the same protocol.~   "
78461|NCT02030405|"~     This phase II trial studies how well ixazomib works in treating patients with relapsed or~     refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
78462|NCT02030392|"~     This trial aims to compare two training programs for children suffering functional abdominal~     pain. These two programs are comparable in number of sessions and group sizes, but show~     differences in content (very focused on pain management vs. more general information and~     support). Focus of the trial is the evaluation of Stop the pain, which has shown high~     effectiveness in one first trial. This time, five clinics, experienced in diagnosis and~     treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are~     eligible. The programs imply six weekly group sessions for the children and 2 parent~     evenings. The study group assumes that participation in Stop the pain will reduce pain~     experience and will improve the children's quality of life and coping strategies - up to 12~     months after training.~   "
78463|NCT02030379|"~     The investigators will leverage e-technologies to provide an online version of the Question~     Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time~     prioritizing of patient questions as well as the seamless delivery of these questions to~     their treating physician (and other members of their clinical team) via the VCU Health~     System (VCUHS) patient portal, and the electronic medical record (EMR) prior to a~     consultation to discuss a clinical trial~   "
78464|NCT02030366|"~     Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such~     as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in~     patients who can benefit from evacuation procedures can lead to worse brain injury, worse~     outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive~     method for diagnosis of TBI severity in the field. In this study we will examine the~     feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by~     examining the pupillary response to multifocal chromatic stimuli in intracranial pressure~     (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for~     pupillary responses using this device.~   "
78465|NCT02030353|"~     The purpose of this study is to test the feasibility of two 6-month behavioral interventions~     for weight gain prevention (self-regulation plus activity monitoring or self-regulation)~     among African American breast cancer survivors along with a delayed control group.~     Participants will be 45 African American post-treatment breast cancer survivors.~     Intervention content will be delivered online with one face-to-face individual meeting.~     Weight, clinical and psychosocial measures will be assessed at baseline, 3 and 6 months. It~     is hypothesized that it is feasible to deliver the two weight gain prevention interventions~     among African American breast cancer survivors, and participants in the two intervention~     groups will have a lower magnitude of weight gain at 6-month follow-up relative to those in~     the delayed control group.~   "
78679|NCT02027558|"~     The purpose of this study is to determine whether a novel intervention combining cognitive~     behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence~     program provided by allied health personnel for older Veterans with obstructive sleep apnea~     and comorbid insomnia improves nighttime sleep, PAP adherence, mood and health-related~     quality of life.~   "
78470|NCT02030288|"~     This project will involve the development and initial evaluation of a promising~     computer-based intervention to improve the primary care management of risky alcohol use~     among Veterans. The intervention uses a Relational Agent, an on-screen person that~     establishes a relationship with the Veteran to promote positive health behaviors. This study~     will determine how Veterans interact with this system, how it can be tailored to Veterans'~     preferences, and its potential effect on risky drinking. If ultimately proven effective, the~     Relational Agent will have several impacts on Veterans and their health care, including:~        -  (1) lower rates of risky drinking in Veterans~        -  (2) improved rates of brief counseling for Veterans with excessive alcohol use~        -  (3) increased proportion of Veterans referred to Mental Health for alcohol disorders~        -  (4) improved care for Veterans with low levels of health literacy.~      This study directly supports Secretary Shinseki's Transformational Initiative to employ~     state-of-the-art information technology to improve quality and access of Veterans' health~     care.~   "
78471|NCT02030275|"~     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the~     recurrence of hypertrophic scar formation following elective revision of a pre-existing~     hypertrophic abdominal scar.~   "
78472|NCT02030262|"~     The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride)~     is better than the other in epiretinal membrane peeling surgery. Both are already used for~     this surgery and this study will tell us if one is better than the other.~   "
78473|NCT02030249|"~     The aim of this study is to investigate possible enduring effects of a standard 2-month~     weight loss program on appetite regulation, bone homeostasis and muscle strength in younger~     and older adults, as well as the impact of differences in dietary composition during weight~     maintenance.~   "
78474|NCT02030236|"~     Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees~     Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain~     function after return of spontaneous circulation when someone has been resuscitated from~     cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.~      The device is a prototype cooling vest. The investigators anticipate that this will be~     useful in ambulances, helicopters and emergency departments where there is a need for a~     portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and~     single-patient use device able to reduce body temperature by at least 1 degree Centigrade an~     hour to initiate cooling. What the investigators are doing in these trials is to demonstrate~     that the investigators can cool people and to get the best design possible for patient use.~     That means some of the initial prototypes will not resemble what we expect the eventual~     device to look like. The investigators will be undertaking the initial trials on 30 normal~     volunteers.~   "
78475|NCT02030223|"~     This prospective, randomized, double blinded, placebo-controlled study is designed to~     evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis~     plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia~     repair with a mesh under general anaesthesia, and how the efficiency of early postoperative~     analgesia achieved correlates with the risk of developing a chronic pain state, a not~     uncommon condition after this type of surgery.~   "
78476|NCT02030210|"~     RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the~     appropriateness of quality indicators retrieved from literature and guideline review. We aim~     to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI~     patients.~   "
78477|NCT02030197|"~     The purpose of this study is to examine the effects of an innovative program, entitled CRISP~     (Community Integration for Socially Isolated Patients), on improving self-efficacy and~     assessing whether improved self-efficacy helps to reduce depression and loneliness of people~     with MS.~   "
78478|NCT02030184|"~     There are two parts to this trial. The first study will evaluate increasing doses of Re188~     P2045 in patients with advanced small cell lung cancer that has recurred after initial~     therapy or in patients with other advanced neuroendocrine cancers that have progressed after~     therapy.~      Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently~     expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell.~     Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks~     out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.~      Therefore, this approach maximizes the possibility that patients will benefit from treatment~     in that only those who have cancers that have the target will undergo treatment. The primary~     purpose of this study will be to determine the highest dose of Re188 P2045 that can be~     safely administered.~      The second study will open after the conclusion of the first. Patients will first undergo~     the scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a~     standard chemotherapy drug that is approved for second line therapy for small cell and~     frequently used for other neuroendocrine cancers. Following that, patients will then be~     re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for~     SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the~     highest dose of Re188 P2045 that can be safely administered after topotecan as well as to~     determine if topotecan will increase the chance that the tumor will express SSTR2.~   "
78479|NCT02030171|"~     Effect of three therapeutics strategies on the restriction of the participation of patients~     with a chronic back pain : multidisciplinary is it the key component ?~   "
78480|NCT02030158|"~     This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA)~     of three EGDT clinical trials.~   "
78481|NCT02030145|"~     The primary goal of this line of research is to see if realistic manipulative protocols can~     be developed to produce sustained reductions in residual volume and improve pulmonary~     function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).~   "
78482|NCT02030132|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
78483|NCT02030119|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
78484|NCT02030106|"~     This is a prospective cohort, enriched with women with a prior term birth, of singleton~     pregnancies who will be followed for the outcome of preterm birth. The main exposure of~     interest is the characterization of the cervico-vaginal microbiota. Women will be recruited~     from a population seeking routine obstetrical care at obstetrical practices at Penn. They~     will have three research visits during pregnancy to complete questionnaires and collect~     samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about~     the prenatal events and timing of delivery.~   "
78485|NCT02030093|"~     Alcohol dependency is the second most common psychiatric disorder and a major public health~     concern. As addictive disorders and now thought to be chronic disorders for many patients~     there is a need for the development of expanded treatment approaches. Because relapse is~     more often the rule than the exception the importance of continuing care after an initial~     phase of treatment is evident. Studies investigating telephone-based continuing care for~     patients with alcohol dependence have shown to be an effective form of step-down treatment~     after a previous stabilisation treatment program and provide extended recovery support.~     Therefore, the investigators hypothesize that alcohol abstinent patients who received~     high-frequency telephone-based or sms-based continuing care show significantly less relapses~     respectively more abstinent days six and twelve months after in-patient treatment compared~     to patients who receive low-frequency or no telephone-based continuing care.~   "
78486|NCT02030080|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
78487|NCT02030067|"~     The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects~     with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to~     estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory~     pancreatic or advanced bladder cancer).~   "
78488|NCT02030054|"~     Statin interference has been suggested among the mechanisms of reduction of the antiplatelet~     effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of~     rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery~     disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a~     single-center, prospective, randomized, crossover study conducted in the Department of Heart~     and Great Vessels Attilio Reale, Sapienza University, Rome, Italy. All consecutive~     patients undergone PTCA in our institution in the period between July 2013 and December 2013~     will be eligible to be enrolled.~      Patients will be offered to participate to the trial at time of 1-month post-angioplasty~     follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90~     mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly~     assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week~     wash-out period to avoid any carryover effect, cross-over was performed, and patients were~     switched to the other drug which was continued for 30 days.~      Platelet function will be evaluated using a validated method: the VerifyNow System~     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical~     detection system that measures platelet-induced aggregation. Platelet function will be~     measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or~     atorvastatin administration.~      Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values >208 are~     suggestive of high platelet reactivity.~   "
78489|NCT02030041|"~     The health benefits of exercise have been widely described, the most notable of which is an~     increase in cardiorespiratory fitness.Cardiorespiratory fitness has been identified as the~     strongest independent predictor of both all cause and cardiovascular disease mortality in~     nearly every population in which it has been examined.~      Statins, a class of hydroxymethylglutaryl-coenzyme A reductase inhibitors that lower~     low-density lipoprotein cholesterol, are commonly prescribed to patients with the metabolic~     syndrome. Statins are widely prescribed in combination with exercise to lower risk of~     cardiovascular disease morbidity and mortality. Every 1 millimole per liter reduction in LDL~     is associated with a 10-20% reduction in risk of cardiovascular events and all-cause~     mortality , while every 1 MET (3.5 milliters of oxygen per kilogram of body weight per~     minute) increase in fitness is associated with an 18% reduction in cardiovascular disease~     mortality and an 11-50% reduction in all-cause mortality. Although the mechanisms are poorly~     understood, some statins have been shown to reduce skeletal muscle mitochondrial content and~     oxidative capacity in humans .~      The muscle is a special potential target for the vitamin D endocrine system. Myopathy is~     well recognized in patients with severe vitamin D deficiency. This myopathy can be rapidly~     and impressively corrected by the appropriate vitamin D therapy. The beneficial effect of~     vitamin D supplementation of severely deficient but otherwise healthy adults on muscle~     weakness, has been reported by improved mitochondrial function.~      Despite the potential public health implications, studies examining the benefits and risks~     of combining statins and exercise in humans are limited. Moreover, Vitamin D may play a role~     in statin mediated changes in exercise adaptations.This study is being done to look for~     effect of simvastatin on exercise mediated cardiorespiratory fitness and the effect of~     vitamin D supplementation in these settings.~   "
78490|NCT02030028|"~     The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease~     the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking~     medications prescribed by their physician and are still experiencing disease symptoms.~      ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis~     since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite~     its FDA approval there is very limited data on its how well ACTH gel works in improving the~     symptoms of people with RA.~   "
79545|NCT02016261|"~     Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted~     depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)~   "
78491|NCT02030015|"~     The investigators hypothesize that a combination therapy using miglustat and the ketogenic~     diet for infantile and juvenile patients with gangliosidoses will create a synergy that 1)~     improves overall survival for patients with infantile or juvenile gangliosidoses, and 2)~     improves neurodevelopmental clinical outcomes of therapy, compared to data reported in~     previous natural history studies. The ketogenic diet is indicated for management of seizures~     in patients with seizure disorders. In this study, the ketogenic diet will be used to~     minimize or prevent gastrointestinal side-effects of miglustat. A Sandhoff disease mouse~     study has shown that the ketogenic diet may also improve central nervous system response to~     miglustat therapy (see Denny in Citations list below). Patients with infantile and~     juvenile gangliosidoses commonly suffer from seizure disorders, and use of the ketogenic~     diet in these patients may therefore also improve seizure management.~   "
78492|NCT02030002|"~     The purpose of this study is to compare bonding time, bond survival, amount of adhesive~     remaining on the tooth surface after bracket debonding, and time required for adhesive~     remnant cleanup between a new flash-free and a conventional adhesive resin for orthodontic~     bracket bonding.~   "
78493|NCT02029989|"~     The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care~     (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome.~     Subjects were also randomized to either an Extended Treatment Group (ETG) defined by~     receiving comprehensive medication management (CMM) pharmacist interventions or a Usual~     Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three~     community mental health clinic settings in Minnesota.~   "
78494|NCT02029976|"~     Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight~     management program to reduce excess weight gain among children, 8 to 12 years old who are~     overweight and at risk of overweight by increasing healthy dietary practices and physical~     activity levels and decreasing sedentary practices.~      Primary Hypothesis: Relative to the control condition, the children receiving the~     intervention will have a significantly lower body mass index (BMI), following implementation~     of the 9-month intervention, controlling for baseline values.~   "
78495|NCT02029963|"~     The purpose of this study is to investigate the use of repetitive transcranial magnetic~     stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known~     to be an effective treatment for major depressive disorder, but there is also evidence that~     it may be effective in the maintenance of remission following treatment. However, it is not~     yet clear what maintenance strategy will yield the best outcome in preventing relapse.~      In this study, eligible patients who have finished one full course of rTMS for treatment of~     major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS,~     and (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS~     six months after the completion of their regular rTMS treatment, the 'taper rTMS' group will~     receive three sessions a week for two weeks followed by two sessions a week for two weeks~     immediately following their regular rTMS treatment, while the 'treatment as usual' group~     will receive standard follow-up care from their own psychiatrist and/or primary care doctor.~      The investigators hypothesize that the group with cluster treatment will show significantly~     lower relapse rates in depressive symptoms as compared to the other groups.~   "
78496|NCT02029950|"~     This phase I trial studies the side effects and best dose of pomalidomide after combination~     chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk~     myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin~     hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by~     stimulating white blood cells to kill cancer cells. Giving more than one drug (combination~     chemotherapy) and pomalidomide may kill more cancer cells.~   "
78497|NCT02029937|"~     The overall objective of this multicenter trial is to determine whether the use of a~     low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the~     efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This~     is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3,~     500) microscope device which can be used during upper endoscopy to image the~     gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our~     collaborators at RICE University and provides >1000X magnified images of the esophageal~     mucosa.~   "
78498|NCT02029924|"~     The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the~     duration of action of insulin lispro due to a facilitation of the absorption of the insulin~     after subcutaneous injection.~      The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in~     subjects with Type 1 diabetes under a dose of 0.2 U/Kg.~      This trial is a single-center, randomised, double-blinded, two-treatment, two-period~     cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes~     mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin~     lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.~   "
78499|NCT02029911|"~     This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical~     study is designed as a non-inferiority study to assess the effectiveness of the Aurora~     Endometrial Ablation System compared to an objective standard. Safety will be evaluated by~     determining the number and percentage of subjects who experience one or more of serious~     adverse events.~   "
78508|NCT02029794|"~     Cervical cancer remains a public health burden, particularly in developing countries such as~     sub-saharan Africa where the infrastructure for organized screening programs does not exist.~     As a result, other screening modalities (visual inspection with acetic acid) are the~     standard of care in such regions. It is now known, persistent infection with an oncogenic~     Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is~     showing HPV testing is a potential, safe and effective alternative to cytology testing (The~     Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection~     vs. VIA in a cohort of women from Kisenyi, Uganda.~   "
80236|NCT02007200|"~     This phase II clinical trial studies how well soy isoflavones work in preventing head and~     neck cancer in patients with stage I-IV head and neck cancer undergoing surgery.~     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy~     isoflavones may prevent head and neck cancer recurrence.~   "
78500|NCT02029898|"~     One of the problems during general anesthesia (GA) for caesarean section is the place of~     opioid agents. Indeed, the literature does not provide so far a clear answer regarding the~     use of opioids prior to extraction of the newborn. Indeed, if the opioid administration at~     induction is beneficial for the mother (better control of autonomic responses to noxious~     stimuli), the impact on the newborn can be unfavorable in terms of adaptation to~     extrauterine life . This is especially true if the birth takes place in a context of~     prematurity and / or acute fetal distress.~      The pharmacokinetics of remifentanil make it the only opioid which is consistent with a~     rapid sequence induction. Its short period of action avoids the manual ventilation of~     patients before intubation, while providing a peak of action concomitant to the nociceptive~     stimulation. Patients at high risk of aspiration, including pregnant women, may benefit from~     this type of morphine at induction. In addition, the fact that remifentanil seems to be~     associated with relative fetal safety in obstetrical or neonatal context legitimized the~     development of protocols to study maternal-fetal consequences of the use of remifentanil at~     induction of AG for emergency caesarean section.~      While cesarean section under general anesthesia mainly concern premature newborns in France,~     no work has focused on the use of remifentanil for caesarean section in a context of preterm~     without preeclampsia.~      The main hypothesis of this study is to evaluate the safety of the use of remifentanil in~     terms of adaptation to extrauterine life in children born prematurely by caesarean section~     under general anesthesia outside the context of preeclampsia.~      To do this, we will compare two groups of children, one consisting of children born by~     cesarean section under general anesthesia with maternal remifentanil infusion, the other~     made up of children born by cesarean section under general anesthesia without maternal~     infusion of remifentanil. This study is prospective, single-center, randomized,~     double-blinded.~      The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes,~     calculated in the delivery room by the team supporting the child (midwives and~     pediatricians).~      The secondary endpoints are formed by maternal hemodynamic parameters (SBP, DBP, MAP, HR),~     the rate of complications during induction (difficult intubation, aspiration), the onset of~     respiratory distress requiring ventilation mask in the newborn, the rate of intubation in~     neonates, and the rate of use of adjuvant anesthetic agents.~   "
78501|NCT02029885|"~     To demonstrate that non-invasive renal denervation is safe and shows a net difference in~     blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.~   "
78502|NCT02029872|"~     This research is being done to learn more about an approach to remove Methicillin resistant~     Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient~     settings and among their household members and sexual partners.~      MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make~     people very sick. The bacteria have been seen in a high number of persons in the Baltimore~     area and in hospitals throughout the country. MRSA can be spread from person to person,~     particularly in homes and among family members and sexual partners.~      There are three things the investigators hope to learn from this research study:~      First, the investigators want to find a way to prevent MRSA infections in outpatient~     settings. By asking questions, the investigators want to look at the things that may~     increase the risk of having this type of bacteria in you and your family members.~      Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications~     (antibiotics; Mupiricin ointment) that have been shown to be effective at removing MRSA. The~     investigators want to determine if these antibiotics and soaps are best used for everyone in~     the household or only the individual with known MRSA.~      Third, as the investigators, we want to learn more about the bacteria by looking at it on~     the inside. The investigators will do laboratory tests on samples we collect, to learn how~     MRSA bacteria grow, reproduce and how it develops to behave differently than other types of~     MRSA bacteria.~   "
78503|NCT02029859|"~     Main objective:~      Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a~     population of obese patients .~      Secondary objectives :~        -  Identify risk factors for OSA during pregnancy (age, parity, high blood pressure,~          snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .~        -  Compare perinatal morbidity among obese patients with OSA in late pregnancy with~          case-controls.~        -  Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.~      Material and methods~      Characteristics of the study:~        -  Interventional biomedical research~        -  Prospective Multicenter nonrandomized study~      Flow chart~        -  Patients will be included between 30 and 36 weeks of amenorrhea (WA) .~        -  Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck~          circumferrence, treated high blood pressure.~        -  As recommended in France, the main test results during the pregnancy follow-up will be~          recorded.~        -  At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.~        -  Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA.~          This screening can be performed as an outpatient.~        -  In case of proven OSA patients will be offered an appropriate care by today's~          standards.~        -  Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months~          after childbirth in case of OSA during pregnancy.~   "
78504|NCT02029846|"~     This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients~     conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West~     Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that~     compared to a regimen base solely on traditional drugs, a regimen including newer drugs will~     achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side~     effects, over the short run.~   "
78505|NCT02029833|"~     The objectives of the study are to examine the health benefits of dietary canola oils on~     body composition, specifically on android fat, and weight management. COMIT II will also~     include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying~     body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin~     sensitivity biomarkers will be done to determine the positive health impact of the changes~     in body composition achieved through canola oil consumption.~   "
78506|NCT02029820|"~     The purpose of this study is to determine whether hydration with intravenous saline matched~     with urine output, using the device RenalGuard is superior to standard hydration with saline~     to prevent contrast-induced nephropathy.~   "
78507|NCT02029807|"~     The investigators have developed a system based on a pulse oximeter, a tablet, and an~     algorithm running on the tablet that analyzes the pulse oximeter waveform.~      The algorithm that runs on this system should be able to accurately keep track of blood loss~     during blood donation. The investigators will compare the algorithm with the blood loss~     tracked by a device called a flow meter.~      The algorithm that runs on this system should be able to accurately keep track of stroke~     volume changes. The investigators will compare the algorithm with the stroke volume changes~     tracked by a device called a CCNexfin.~      The algorithm that runs on this system should work whether it's in place for the whole blood~     donation, or if it's placed after the blood donation has started. The investigators will use~     two pulse oximeters for the system on each hand and compare one that is used for the whole~     blood donation versus one that is not used for the whole blood donation.~   "
78509|NCT02029781|"~     SUMMARY~      Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis~     appendicitis. However until recently evidence-based laparoscopic criteria for determining~     appendicitis were not defined. If there is any doubt about the presence of appendicitis the~     appendix is usually removed. In a single centre prospective pilot study on 134 patients the~     investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current~     study the investigators will validate the LAPP score in order to decrease the negative~     appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.~      Objective: To decrease the negative appendectomy rate by 50%.~      Study design: A multicenter prospective validation study~      Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the~     clinical suspicion appendicitis. Sample size calculation, performed by a statistician/~     epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.~      Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843),~     were retrospectively analysed for negative appendectomies. This cohort will serve as the~     control group. In this control group no intervention was given, as the LAPP score was not~     yet defined.~      In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic~     laparoscopy. With the LAPP score the investigators intend to halve the number of negative~     appendectomies.~      Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%.~     This decrease should not lead to an increase in missed appendicitis (occurring within 30~     days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular~     infiltrate on an ultrasound or CT-scan.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of~     the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an~     increase in morbidity.~   "
78510|NCT02029768|"~     Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn~     injury and this correlates with clinical markers of outcome~      Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune~     response (CMI) dysregulation in response to burn injury~      Skin-fold caliper measurements will be taken on consented patients (both male and female) to~     determine body fat percentage. Serum samples will be obtained from these patients. The level~     of inflammatory cytokines in the serum will be measured to determine if there is a link~     between body fat percentage, pro-inflammatory cytokines and the ability of women to survive~     burn injury.~   "
78511|NCT02029755|"~     Postoperative analgesia is an important part of the anesthetic care. According to the recent~     studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer~     side effect. For example, combining intravenous, intramuscular or oral analgesics with~     transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the~     multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.~      For abdominal surgery, both local infiltration and TAP block target on relieving somatic~     pain. Local anesthetic wound infiltration is easy to perform with low risk. As the~     advancement of ultrasound technology, performing the TAP block also becomes easier, safer~     and more accurate. But whether LA infiltration or TAP block is better for the multimodal~     analgesia regimen remains unclear.~      This study is to compare the postoperative pain score, opioid consumption, side effects, and~     quality of recovery between these two analgesic methods in patients undergoing abdominal~     surgery. The investigators hypothesized that TAP block may be more effective than LA~     infiltration as a part of the multimodal analgesia, and can improve the recovery after the~     abdominal surgery.~   "
78512|NCT02029742|"~     The investigators propose that culturally aligned community-based interventions in our~     multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication~     technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to~     use, supporting parent-youth partnerships for chronic disease self-management and~     reinforcing the behavior of daily medication use. Culturally aligned community health~     workers (CHW) are a well-established means to support chronic disease self-management by~     underserved families, in partnership with medical homes. CHWs can identify and address~     multiple barriers and reinforce developmentally appropriate self-management to help youth~     reach and maintain their best fetal hemoglobin (HbF) levels. However, this strategy alone~     may be insufficient to achieve daily HU adherence. The investigators therefore propose a~     feasibility trial to test the feasibility and acceptability of a structured intervention of~     CHW support to address existing barriers to improve HU use, augmented by daily cue-based~     parent and youth text message reminders, to efficiently extend CHW family support and~     reinforce family partnerships for self-management.~   "
78513|NCT02029729|"~     This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum~     tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in~     patients with advanced solid tumors that are refractory after standard of care therapy for~     the disease. The results of this study will help provide clinical information for the design~     and conduct of further clinical studies with RTA 408 in cancer patients.~   "
78514|NCT02029716|"~     This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a~     novel small molecule which suppresses oxidative stress and inflammation. In this study, the~     safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be~     evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study~     will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA~     408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface~     area (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the~     local skin tolerability, local PD, and systemic PK of these treatments. Part B will be~     conducted after completion of Part A and will assess the safety, tolerability, local PD, and~     systemic PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin~     surface area (~100 cm2). Part C will be conducted after completion of Part B and will assess~     the safety, tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically~     twice daily for 28 days to a larger skin surface area (~500 cm2). The maximum tolerated drug~     concentration in Part A will be used in Part B and Part C.~      Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers~     in Part A and 10 volunteers each, in Parts B and C.~   "
78515|NCT02029703|"~     The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance~     and performance, resulting in improved knee function and pain when compared to a group that~     receives a sham injection (an injection that does not have medicine) only before a~     standardized physical therapy regimen over 10 weeks.~   "
78516|NCT02029690|"~     A study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme in~     patients with histologically proven advanced malignant pleural mesothelioma (MPM), advanced~     peritoneal mesothelioma (in dose escalation cohort only), non-squamous non-small cell lung~     carcinoma stage IIIB/IV (NSCLC), metastatic uveal melanoma, hepatocellular carcinoma (HCC),~     glioma and sarcomatoid cancers~   "
80237|NCT02007187|"~     The purpose of this study is to determine the efficacy and safety of Danhong injection in~     the treatment of unstable angina pectoris.~   "
78517|NCT02029677|"~     The purpose of this research study is to determine how changes in levels of obesity-related~     hormones in the gastrointestinal tract following Laparoscopic Adjustable Gastric Banding~     (LAGB) surgery may lead to a decrease in appetite and weight loss. Learning exactly how the~     Lap Band works may help us to develop new, less invasive treatments for morbid obesity. This~     knowledge may also lead to the development of preventive, cost-effective treatment~     strategies. As a control subject, participants will provide a comparison for changes in~     these hormones with medical weight loss compared to weight loss after LAGB surgery.~   "
78518|NCT02029664|"~     The purpose of this study is to determine the possibility of gait pattern change via visual~     feedback among patients with stroke. Also, the optimal visual feedback would be chosen from~     this study.~   "
78519|NCT02029651|"~     The purpose of this study is to determine whether novel upper extremity rehabilitation~     system for patients with stroke(e-glove system) are effective in the rehabilitation compared~     to conventional occupational therapy~   "
78520|NCT02029638|"~     The purpose of this study is to find out if the study treatment will allow people to accept~     their new kidney and be able to stop taking anti-rejection medications.~   "
78521|NCT02029625|"~     The purpose of this study is to compare the pharmacokinetics of NVP-1205 and~     coadministration of rosuvastatin and ezetimibe.~   "
78522|NCT02029612|"~     The goal of this research study is to compare 2 different phone-based programs for quitting~     smoking for people with HIV/AIDS.~   "
78523|NCT02029599|"~     The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi~     granules in subjects with Rheumatoid Arthritis.~   "
78524|NCT02029586|"~     This is a controlled study to determine the effectiveness and safety of MB12066 in the~     treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.~   "
78525|NCT02029573|"~     The purpose of this study is to explore the efficacy and safety of Atorvastatin in~     combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed~     by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The~     anticipated time on study treatment is until disease progression, and the target sample size~     is 32 individuals.~   "
78526|NCT02029560|"~     To evaluate effect on cardiovascular system(blood pressure) when Thrupas® capsule is~     administered every day for 12 weeks in patients with Lower Urinary Tract Symptoms suggestive~     of Benign Prostatic Hyperplasia~   "
78527|NCT02029547|"~     This study is designed to validate the Japanese electronic florbetapir (18F) interpretation~     training program intended for post-approval implementation in Japan.~   "
78528|NCT02029534|"~     This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for~     the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is~     that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared~     to 20 mg.~   "
78529|NCT02029521|"~     Many individuals with cystic fibrosis experience growth failure. The reasons are not clear,~     but inflammation of the gut in these patients seems to be one important reason. Glutathione~     is important to normal function of the intestine and lungs. Glutathione functions to~     decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets~     trapped inside of cells, so it cannot travel to the surface of the cells and perform its~     proper function. Moreover, glutathione has been shown to improve nutritional status in~     patients with AIDS and cancer.~      Investigators hypothesize that supplementation of oral glutathione to pediatric individuals~     with cystic fibrosis could improve growth failure.~   "
78530|NCT02029508|"~     The purpose of this study was to compare the treatment effectiveness of three different~     methods for posterior semicircular canal benign paroxysmal positional vertigo. The included~     methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.~   "
78531|NCT02029495|"~     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to~     placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate~     the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective~     of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic~     arthritis.~   "
78532|NCT02029482|"~     This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1~     study. Sixteen subjects in two groups (at least 40% of subjects of either male or female~     sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to~     100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending~     doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg,~     60 mg, 80 mg, and 100 mg.~   "
78533|NCT02029469|"~     It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are~     treated with the Ascension® HRA. Its purpose is to measure and document the outcomes~     associated with implanting the Ascension HRA prosthesis. Patients will be periodically~     assessed to collect data related to safety and effectiveness endpoints at the following~     intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5~     year, and 10 years.~   "
78534|NCT02029456|"~     The aim of the present study was to assess the effects of low-dose (25mg) prolonged~     administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital~     mortality and outcomes in patients with massive PE.~   "
78535|NCT02029443|"~     This study is evaluating the safety and efficacy of a new Bruton tyrosine kinase (Btk)~     inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small~     lymphocytic lymphoma (SLL)~   "
78536|NCT02029430|"~     This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV~     positive subjects with Kaposi's sarcoma.~   "
78537|NCT02029417|"~     This phase II trial studies the side effects and how well omacetaxine mepesuccinate,~     cytarabine, and decitabine work in treating older patients with newly diagnosed acute~     myeloid leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth.~   "
78558|NCT02029144|"~     Dydrogesterone has been widely used worldwide for various gynecological and obstetric~     indications:~        -  Dydrogesterone is effective in cycle regulation treatment.~        -  Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO)~          axis in the recommended dosage.~        -  Dydrogesterone might have non-negative effect on glucose and lipid metabolic.~   "
78538|NCT02029404|"~     We will enroll patients submitted to feet elective orthopaedic surgery that require~     analgesia through continuous peripheral nerve block (CNPB) of the sciatic nerve. All~     catheters will be placed by anaesthesiologists experienced in ultrasound in prone~     positioning. The patients will be randomized in two groups with technique of sealed~     envelopes.~      In the tibial -peroneal nerve (TPN) group we will position the catheter within the~     confluence of peroneal and tibial nerve.~      In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a~     catheter medially to tibial branch of the sciatic nerve according to in plane approach.~      We will analyze A: the difference in consumption of local anesthetic in the two different~     groups B: the difference of insensate limb in the post-operative home as described by~     Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the~     sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of~     dislodgment of the catheters, patient satisfaction, need for intervention by the~     anesthesiologist after discharge.~   "
78539|NCT02029391|"~     Musculoskeletal dysfunction is considered as a major public health problem affecting about~     one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial~     trigger points as well as fascia tenderness are thought to be the main cause of~     musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to~     reduce pain and restore normal function. Clinically, some evidence supports the application~     of kinesio tape in these patients. The underlying mechanism, however, is not clear. The~     investigators goal was to validate proposed mechanism of kinesio tape in these patients. The~     primary outcome are muscle stiffness, pain intensity and sensitivity.~   "
78540|NCT02029378|"~     Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in~     the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory'~     disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS~     patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients~     also have double vision or problems with swallowing. GBS mau also involve the respiratory~     muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS~     pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period~     ranging from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies.~     Progression of weakness in GBS is usually rapid and reaches its peak within 4 weeks in the~     majority of patients, but many develop their maximum deficit within 2 weeks. Thereafter, the~     patients have a variable prognosis.~      GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days~     was shown to be effective when administered within the first two weeks after onset of~     symptoms, and is considered the treatment of choice by most experts in the field. Although~     the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days),~     many patients fails to recover abd remain with substantial disability. Patients with GBS and~     especially those with a poor prognosis potentially may benefit from more powerful abd when~     possible a more mechanistically rational therapy.~      Recent experimental evidence suggests that complement activation palys a crucial role in the~     development of neuromuscular weakness in GBS making complement inhibitors and regulators~     attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a~     complement inhibitor, will be very effective in preventing progression of weakness in~     patients with GBS.~   "
78541|NCT02029365|"~     In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility~     remains  unexplained . Among the causes of female infertility , there are the eating~     disorders, as well as sexual disorders , these two cases may be linked. In addition, data~     from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding~     behavior of infertile women is more often disturbed than the general population. Moreover,~     the notions of desire for a child and maternal representations seem essential to address in~     the comprehensive care of women with infertility but also TCA integrating all conflicting~     issues reactivated at the time of motherhood. However, little work has been done on this~     subject. Thus, we propose a study on the desire for children and the eating disorders to~     infertile women, to update epidemiological data, but also to better characterize this~     particular patient population. Perspectives of this work are to improve screening measures~     and support through a joint work of doctors reproductive and psychiatrists.~   "
78542|NCT02029352|"~     Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in~     Caucasians, representing approximately 80% of cases. Incidence rates for men and women in~     the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising~     3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed~     BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%).~      A simplified classification of BCC includes the following three histological subtypes:~     nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs)~     differ from the other subtypes as they tend to appear at a younger age, usually occur on the~     trunk and are often multiple. This subtype has the fastest growing incidence.~      A characteristic feature of BCCs is their low risk to metastasize, though if untreated they~     may induce considerable functional and cosmetic morbidity as they are locally invasive.~     Surgery is the first treatment of choice for BCC. However due to the rising incidence and~     the extensive workload this entails, a non-invasive topical treatment is often chosen for~     sBCC as they grow down from the epidermis into the superficial dermis and therefore are~     easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or~     5-fluorouracil cream are available topical treatments for sBCC however their tumour free~     survival rates are not equal to the higher tumour free survival rates of surgical treatment.~     Next to the efficacy, the now available topical treatments are associated with local skin~     reactions at the treatment site, mainly erythema and erosion (imiquimod cream and~     5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for~     additional or alternative non-invasive topical treatments.~      The active constituents of green tea are promising as they are supported to have~     anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies.~     The so-called polyphenols known as catechins are the active constituents of green tea and~     the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG~     is thought to have a cytotoxic effect on skin cancer cells and has the availability of~     inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a~     role in inactivation of β-catenin signalling, an important component of the WNT pathway.~      Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the~     species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins~     (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the~     US Food and Drug Administration (FDA) for genital warts in adults.~      There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this~     trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG~     in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus~     placebo for the topical treatment of sBCCs.~   "
78543|NCT02029339|"~     The closed systems, such as conventional negative pressure wound therapy (NPWT), were~     usually avoided in infected or critical colonized wounds. To our observation, the additional~     continuous irrigation tube attached beside the suction tube in the NPWT system could provide~     the effective drainage by reducing the occlusion of suction tube, enable effective~     debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by~     providing relatively moist ambient. At our institutions, the modified system combined with a~     triple-tube device to allow a continuous instillation became more active and efficient.~     The study is to investigate if a continuous triple-tube instillation and suction could~     improve the outcomes of acute severely infected open abdomen.~   "
78544|NCT02029326|"~     Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by~     obtaining a level of sensitivity down to single tumor cells without compromising~     specificity. This allows assessment of multiple TKI treatment targets, their activation~     status, as well as down stream signaling proteins using very tiny amount of tissue that can~     be obtained by FNA or CTCs.~      We planned this study to explore biomarkers predictive of clinical response to~     cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We~     will also elucidate signal transduction pathway attributable to cetuximab resistance,~     monitor changes in the RTK activation status during cetuximab treatment using circulating~     tumor cells and analyze correlation between the quantity of circulating tumor cells and~     treatment response to cetuximab.~   "
78545|NCT02029313|"~     The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled,~     2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic~     Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in~     Healthy Male Korean Subjects~   "
78559|NCT02029131|"~     Evaluation of the effectiveness of an individually educated exercise program for the lower~     back at home in employees over a period of 20 weeks.~      We hypothesize that regular exercise for the lower back results in greater improvements of~     low back strengths compared to controls.~   "
78560|NCT02029118|"~     Hypothesis: acupoint application is effective for managing chronic stable angina pectoris.~     Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints~     for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200~     participants will be included. Four arms: herbal medicine application on acupoint group ,~     placebo application on acupoint group , herbal medicine application on non-acupoint group~     and placebo application on non-acupoint group.~   "
78546|NCT02029300|"~     There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In~     general, nasal intubation by any conventional method may be the preferred choice for certain~     procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth~     opening. If nasal intubation is not indicated or preferred, then oral intubation is usually~     performed.~      This study is looking to explore whether or not the nasal route significantly improves the~     ease and time for successful fiberoptic intubation compared to the oral route in children~     less than or equal to 2 years of age. This study will also examine if operator experience~     influence time to tracheal intubation with either route?~      The investigators hypothesize that the nasal route of fiberoptic intubation will be faster~     than the oral route, for both the trainee and the expert, and that there will be minimal~     differences between experts and trainees with nasal fiberoptic intubation.~   "
78547|NCT02029287|"~     The purpose of this study is to determine whether the Hospital-Community-Family-Care~     Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and~     costs of the subjects with CHF.~   "
78548|NCT02029274|"~     This study investigates the dose response relationship for the efficacy and safety of BAF312~     compared to placebo in active DM patients over a treatment period of 6+6 months and to~     determine the minimum dose required for a maximal clinical effect. The study is composed of~     2 periods: a double-blind period I with BAF312 administered at different daily doses (0.5,~     2, 10 mg and placebo) and a fixed-dose Period II in which BAF312 will be administered at the~     dose of 2 mg daily .~   "
78549|NCT02029261|"~     The purpose of this study is to examine important and significant problems, that of insulin~     resistance and muscle wasting after burn injury.~   "
78550|NCT02029248|"~     Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the~     distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range~     from the minor and easily treated with an excellent functional prognosis, to those that are~     complex and often associated with a poor functional prognosis.~      Despite the better knowledge of the anatomy and physiology and the improvement of surgical~     management after birth, fecal and urinary incontinence can occur, due mainly to deficient~     nerve supply.~      The quality of life of such patients is largely unknown in this country. The aim of the~     investigators study is to propose specific and generic questionnaires to the patients~     registered in the national database, correlated to their anatomical and functional status. A~     better understanding of such correlations should allow improvements in their medical and~     social management.~   "
78551|NCT02029235|"~     The purpose of this research study is to find out which combination of pain medications~     following surgery work the best and result in the fewest side effects.~   "
78552|NCT02029222|"~     Patients with lung cancer may develop a second primary tumor or recurrent disease after~     previous radiotherapy. Surgical salvage therapy is the mainstay of therapeutic options.~     However, in case of irresectable disease, re-irradiation should be considered. Also in the~     postoperative setting, re-irradiation is considered after surgical salvage in case of~     features in the pathology specimen indicating a high risk for subsequent recurrence. However~     after re-irradiation, there is a high risk of 43% grade 3 (late) toxicity at 5 years~     (including possible fatal complications) and a relatively low chance of locoregional control~     of 50% at 5 years. One out of three patients survives re-irradiation without recurrence and~     severe complications. Improvements in both the risk of radiation-induced complications and~     the oncological outcome are thus warranted.~      Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the~     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring~     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than~     that of conventional radiotherapy (RT) with photons, it is necessary to establish whether~     these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence~     of the situations in which PT outperforms conventional photon treatment is needed.~     Publications on this topic are rare. The only recent publication has analyzed the results of~     37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy~     [Kruser in press].~      We propose an in silico trial to investigate to what extend proton and 12C-ion therapy~     decrease the amount of irradiated normal tissue in lung cancer patients treated with~     radiotherapy after an initial radiotherapy treatment.~   "
78553|NCT02029209|"~     1. To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in~          the phase II study of anlotinib in patients with advanced non-small cell lung cancer.~        2. To clarify the meaning of peripheral markers and blood perfusion parameters in vivo~          tumor in predicting the effect of anti-angiogenic therapy.~   "
78554|NCT02029196|"~     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are~     otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems.~     These may look like conventional cigarettes but do not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the safety and tolerability of an e-vapour product.~   "
78555|NCT02029183|"~     Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there~     is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment~     with noninvasive ventilation for patients with acute ischemic stroke should improve the~     functional prognosis（measuring with 90d modified Rankin score）.~   "
78556|NCT02029170|"~     Unstable ankle fractures are commonly treated operatively. After operative reduction and~     fixation of the fractures, there are varying rehabilitation regimes that include~     non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or~     brace, or early protected weightbearing in a rigid cast. Several papers reported that early~     weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early~     return to activities. However, early weightbearing may have the risk of displacement of the~     fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not~     clear. We hypothesized that the ankle function assessed on 12 months after operation of an~     ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior~     to non-weightbearing with respect to time to return to normal daily life and time to full~     weightbearing.~   "
78557|NCT02029157|"~     The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with~     hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic~     chemotherapy regimen including sorafenib.~   "
78562|NCT02029092|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the~     collection of clinical evidence for the clinical performance and safety of ORSIRO drug~     eluting stent system in daily clinical practice.~   "
78563|NCT02029079|"~     Malnutrition increases the risk of complications and predisposes ti infections through~     impaired immune response and wound healing. Healthcare costs related to the management of~     malnourished patients is estimated to be more than double the amount spent managing non-~     malnourished~      The objective of this study is to examine the effect of newly developed energy and~     nutrients-dense beverage product on the nutritional status among patients at risk of~     malnutrition.~   "
78564|NCT02029066|"~     This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As~     safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body~     temperature) will be recorded.~   "
78565|NCT02029053|"~     This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal~     ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010~     is designed to release glycerol. The study will assess the duration of lubrication/~     moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and~     participant satisfaction of the device.~      Study participants will insert the intravaginal ring and leave it in place for an initial 7~     days and then repeat this process a 2nd time. Participants will respond to questionnaires,~     complete a daily diary and come in for 4 separate study visits. Each study visit will~     involve a brief vaginal exam.~      Upon removal of the initially inserted device (7 days after first study visit), participants~     will insert a second device for an additional 7 days and undergo the same evaluation.~   "
78566|NCT02029040|"~     This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department.~     The primary objective is to determine whether nebulized 3% hypertonic saline is more~     effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency~     department.~   "
78567|NCT02029027|"~     The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator,~     during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI~     (composed predominantly of stress UI), that responded to physiotherapy were included in this~     study in two parallel groups. The groups followed a self-reeducation program, with or~     without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based~     on the rate of women for whom the benefit of the initial perineal reeducation was~     maintained.~   "
78568|NCT02029014|"~     The aim of this study is to assess the efficacy, safety and performance of LAmbre left~     atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot~     be treated with Warfarin.~   "
78569|NCT02029001|"~     MOST is a phase II trial conducted in adult patients with an advanced solid tumor in~     progression after at least 1 prior treatment regimen. The study aims to assess whether a~     12-week treatment with a targeted therapy selected based on the alteration(s) detected in~     the tumor is sufficient to stabilize the disease compared with a longer treatment, for all~     patients presenting this alteration, regardless of the primary disease site or cancer type.~     All the targeted therapies administered in MOST study already obtained a marketing~     authorization (MA) but will be evaluated in indications other than those defined in their~     MA.~      Each patient enrolled will receive the matching targeted therapy during 12 weeks (induction~     treatment). At the end of this period:~        -  patients with a tumor response will continue the targeted therapy,~        -  patients in progression will discontinue the targeted therapy and will be withdrawn~          from study and oriented towards standard treatments~        -  patients with a stable disease at 12 weeks will be randomized in order to determine if~          they continue or stop the targeted therapy.~      About 80 patients will be treated in each of the 5 treatment groups opened to enrollment,~     each group corresponding to an available targeted therapy.~   "
78570|NCT02028988|"~     This research study is evaluating a drug called enzalutamide in combination with external~     beam radiation therapy as a possible treatment for prostate cancer. Presently, when~     participants receive hormonal therapy with radiation therapy for prostate cancer,~     medications are given to reduce testosterone levels in the blood stream. This leads to side~     effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle~     strength. The purpose of this study is test another form of hormonal therapy with radiation~     therapy. The medication called enzalutamide will be used with radiation therapy. Instead of~     lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if~     enzalutamide when used with radiation will lower the PSA without causing the side effects~     associated with medications that lower testosterone in the blood stream.~   "
78711|NCT02027142|"~     This study included women referred to two academic centres for the diagnosis and treatment~     of endometriosis (cases) and women referred to our Institutions because of routine~     gynaecologic consultations (controls). In this age-matched case-control study, the aimdy was~     to assess quality of sleep, the average daytime sleepiness and insomnia in patients with~     endometriosis by using three different self-reported questionnaires.~   "
78571|NCT02028975|"~     Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is~     accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim~     to determine in healthy humans whether the orosensory perception of fatty acids is followed~     by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1,~     secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue~     (leptin, ghrelin, adiponectin).~      We also aim to determine whether the hormonal response induced by orosensory stimulation by~     lipids is modified:~        -  in patients with type 2 diabetes~        -  in obese non-diabetic patients We expect to show an increase in biological markers~          biological, and more particularly in certain digestive hormones such as Pancreatic~          polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will~          also determine whether or not this response is modified in patients with type 2~          diabetes and in obese non-diabetic patients.~      We also wish to measure the subjects' gustatory detection threshold for a fatty acid~     (linoleic acid), and to determine whether there is a relationship between the orosensory~     perception threshold for linoleic acid and the physiological status of the subjects. In~     order to achieve this, the thresholds for healthy subjects will be compared with thresholds~     for obese and diabetic subjects. Expected results: the threshold of detection for linoleic~     acid in healthy subjects will be lower than that in obese or diabetic patients.~   "
78572|NCT02028962|"~     The research aim is the development, implementation and evaluation of the first computer~     tailored smoking cessation progam for Romanian adult smokers. It will be implemented among~     smokers from Romania aged 20-60 years. The participants will beneficiate of tailored~     information received in letters generated by using sophisticated computer algorithms,~     allowing the creation of highly individualized messages that address each individual's~     unique needs, motivations and beliefs related to smoking .~      Program implementation will comprise of :~        1. ''diagnosis'' by means of questionnaires at the individual level of characteristics~          that are relevant for a person's smoking behavior~        2. development of the ''message library'' that contains all education messages that may be~          needed~        3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis,~          selects and generates messages tailored to the specific needs of the individual user~        4. generating of personalized letters for each participant~        5. sending of theses personalized letters to the participants. The participants will~          receive three personalized letters during a period of six months after registration~          into the program.~      The effects of the program will be evaluated with a randomized controlled trial which will~     assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy~     and quiting attempts at 6 months after the enrolment into the program.~      A process evaluation will assess participants' opinion about the program.~   "
78573|NCT02028949|"~     Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor~     prognosis as there are no recommended curative treatments. Chemoembolisation is the most~     widely used treatment in these patients, but this technique can prove to be toxic.~     intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective~     therapeutic approach, without deteriorating liver function.~      The rationale for this treatment can be resumed as follows:~        -  HCC are vascularised via the hepatic artery system~        -  The IHA perfusion of anthracyclines leads to high elimination via the liver with low~          systemic concentrations~        -  The absence of embolisation reduces toxicity~        -  the toxiciity profile of idarubicin is well known and the drug is widely used for the~          IV treatment of leukemia~        -  idarubicin is the most cytotoxic drug for tumor cell lines.~        -  The in vitro cytotoxicity of idarubicin is 100% at low concentrations~        -  Lipiodol can stay in contact with tumor tissue for several weeks after injection and~          act as a vector for the drug~        -  The idarubicin-lipiodol is more stable than lipidol emulsions usually given by~          intraarterial injection~        -  The emulsion is more stable with idarubicin than with other anticancer molecules~        -  Sequential inclusion in accordance with the continual reassessment method makes it~          possible to increase inclusions at a target toxicity level while reducing inclusions at~          doses that are too low or too toxic The aim of the treatment is to improve survival.~   "
78574|NCT02028936|"~     Many epidemiological and clinical studies have suggested the negative effect of oxidative~     stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably~     in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.~      Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary~     supplementation with polyphenols in high-risk patients could diminish the harmful~     consequences of oxidative stress.~      The aim of this study is to show that the daily consumption of grape juice rich in~     polyphenols  R@isol , has a positive impact on the oxidation/antioxidation balance in~     healthy volunteers.~   "
78575|NCT02028923|"~     This phase III study aims to show that topical morphine low doses treats localized pain in~     chronic wounds, intense and rebellious to systemic analgesics included or not opioids.~   "
78602|NCT02028572|"~     Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal~     ganglion cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive~     glaucomatous visual field defects. It is considered to be one of the major causes of~     blindness worldwide.~      It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before~     statistically detectable visual field defects appear on automated visual field testing,~     which is also consistent with post-mortem histologic findings in glaucomatous eyes. Since~     the damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is~     considered as an early sign of glaucomatous damage, its early detection and prevention is~     warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive,~     reproducible technologies such as optical coherence tomography, scanning laser polarimetry~     etc.~      The purpose of the study is to evaluate the relationship between visual fields and retinal~     nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence~     tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary~     open - angle glaucoma.~   "
78603|NCT02028559|"~     A feasibility study to test the ability to move kidney stones using a modified ultrasound~     system. It is the goal of our technology to move the stone fragments to a location within~     the kidney to improve their chances of passage, and thus reduce the occurrence of additional~     symptomatic events and retreatment.~   "
78576|NCT02028910|"~     Acute gastroenteritis is a common disease especially in children. With bronchiolitis and~     influenza, she participated widely in weight of winter epidemics that causes problems every~     year our health care system, particularly in the pediatric emergency and inpatient since~     they are the second leading cause of hospitalization in children. The main symptoms of viral~     acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of~     sometimes severe dehydration, the most common cause of hospitalization. There is no specific~     treatment for these infections. At most, there is a vaccine against severe rotavirus~     diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in~     France. The treatment of acute gastroenteritis virus is symptomatic and is generally based~     on the use of oral rehydration solutions (ORS) whose administration is limited by the~     frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on~     vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely~     prescribed, are ineffective in practice, very few studies in this indication and encumbered~     side effects. Several drugs have long been used in children to fight against severe vomiting~     associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril~     ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known.~     They act both on the enteric nervous system by blocking serotonin receptors. Several~     placebo-controlled trials suggest that ondansetron is effective in reducing the number of~     vomiting in children emergency consultant for acute gastroenteritis. However, the method~     used in these tests and the number of children enrolled has not yet demonstrated the~     efficacy of ondansetron on the number of admissions, the number of emergency and return the~     cost / benefit ratio of this treatment. In addition, several studies reported the occurrence~     of watery stools more frequently in children treated with the placebo group.~      Evidence that ondansetron is well tolerated and effective for reducing the severity of~     vomiting during acute gastroenteritis pediatrics winter could support the use of this~     treatment in routine pediatric emergencies.~      This study is a clinical trial, multicenter, controlled versus placebo whose main objective~     is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children~     with acute gastroenteritis during winter emergencies Upon arrival to the emergency room~     after signing. Consent, an ECG is performed in eligible patients. Children meet all the~     criteria for inclusion and non-inclusion receive, at random, one of two treatments:~     ondansetron (active) or placebo. The study does not alter the usual care of the child to the~     emergency room. After passing emergency, patients will be followed in the study for 8 days,~     through a phone call home to J3 and J7. The total duration of patient participation in the~     study is 8 days, including 4 hours emergencies (usual transit time to emergencies).~   "
78577|NCT02028897|"~     This study will compare two alternative embryo culture systems. Embryos from each patient~     will be randomly assigned to one of two systems. One group will be cultured conventionally~     in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.~   "
78578|NCT02028884|"~     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,~     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD~   "
78579|NCT02028871|"~     This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in~     reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.~   "
78580|NCT02028858|"~     This is a prospective, observational study designed to describe the effects of Cannabis on~     Parkinson's Disease tremor.~   "
78581|NCT02028845|"~     1. Background~             -  Advanced guidewires with a U-shaped tip could effectively cross the long or~               multi-occlusive segment smoothly and go into the distal outflow vessel.~             -  The guidewire looping technique is a safe and effective method for the~               recanalization of the occluded lesions in infrapopliteal vessels.~        2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped~          guidewire in achieving successful deep biliary cannulation.~        3. Design~           - Prospective randomized trial.~        4. Setting:~           - Tertiary-care medical center~        5. Patients~           - This study will involve 192 patients with biliary diseases which require endoscopic~          retrograde cholangiopancreatography.~        6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a~          straight-tipped guidewire~        7. Main outcome measurements - Compare the cannulation success rate, the duration of the~          cannulation, immediate and late complications.~   "
78582|NCT02028832|"~     This study will investigate if adding complementary therapies such as acupuncture, massage~     and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such~     as patient symptoms, cost, safety, satisfaction and length of stay.~   "
78583|NCT02028819|"~     Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human~     T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+~     lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and~     HIV-infected individuals showing safety and efficacy for suppressing HIV replication.~   "
78584|NCT02028806|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as~     first-line treatment for metastatic pancreatic cancer in China.~   "
78585|NCT02028793|"~     National Health Insurance Administration, Taiwan has provided a protocol for community~     pharmacist to offer home pharmaceutical care for the patients with high health expenditures.~     Since community pharmacists need to visit patients for consultation and check their~     medications, it has been thought to have pressure for them in various areas. This study~     intends to investigate the factors related to the pressure and intention for leaving this~     protocol. The hypothesis are that community pharmacist who works longer, has economic~     pressure, and longer year of practice will have higher pressure and strong intention for~     leaving.~   "
78586|NCT02028780|"~     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI~     655075 following intravenous administration of single rising doses of BI 655075 when~     administered alone and after administration of dabigatran.~   "
78587|NCT02028767|"~     The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed~     dose combination tablets compared to tablets administered together in healthy male and~     female volunteers under fed conditions.~   "
78588|NCT02028754|"~     This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the~     treatment of dry eye after cataract surgery.~   "
78589|NCT02028741|"~     The purpose of this study was to explore the immediate effects of transversrse vertebral~     pressures (TVP) to the thoracic spine on cervical range of motion and pain in subjects with~     neck pain,~   "
78604|NCT02028546|"~     The purpose of this study is to determine the hydration effect of various regimens of skin~     bathing and moisturizer application on atopic dermatitis~   "
78605|NCT02028533|"~     This is a pilot feasibility study assessing the tolerability of chronic administration of~     intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are~     actively using cocaine.~   "
78644|NCT02028013|"~     Bioresonance is the big promise of the medical technology of the future because it~     stimulates the self-regenerating system of the body by affecting the body`s most essential~     procedures. The big advantage is that its multiple and there are no harmful side effects.~     This therapy teaches something to the body what in a younger and healthier state it had~     already Bioresonance is based on the scientific principle that metabolism within cells is~     influenced by one's electromagnetic field.~      We start to use bioresonance technology in management of erectile dysfunction , premature~     ejaculation, decreased libido.~   "
78590|NCT02028728|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the~     collection of clinical evidence for the clinical performance and~   "
78591|NCT02028715|"~     The investigators' goal in this planned prospective, randomized, patient blinded study is to~     compare our standard of care as the control group to an experimental group in which patients~     receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8~     doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will~     include amount of rescue opioids required, time to return of bowel function, length of~     hospital stay, cost effectiveness, and patient satisfaction. The hypothesis is that the~     addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease~     the incidence of associated gastrointestinal side effects including nausea, vomiting,~     bloating, and constipation. The hope is that it will affect the final outcome of quicker~     return of bowel function, increased patient satisfaction, shortened hospital stay and prove~     to be an overall more cost effective postoperative pain management approach.~   "
78592|NCT02028702|"~     To investigate the reported health benefits (lipid profile, inflammatory factors,~     cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment~     on women suffering from both menopause related primary (hot flushes, night sweats, sleep~     disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in~     lipid metabolism) symptoms.~   "
78593|NCT02028689|"~     This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of~     metformin and furosemide in healthy, adult male subjects.~   "
78594|NCT02028676|"~     The two original objectives were to determine in HIV-infected children initiating~     antiretroviral therapy (ART):~        1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of~          disease progression or death as routine laboratory and clinical monitoring (LCM) for~          toxicity (haematology/biochemistry) and efficacy (CD4)?~        2. Whether induction with four drugs from two ART classes followed by maintenance with~          three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse~          transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical~          outcome?~           Two secondary objectives were to determine~        3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir~          after 48 weeks on ART will have a similar outcome in terms of virological suppression~          and will result in improvements in adherence to ART?~        4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who~          have been on ART for at least 96 weeks has a similar outcome in terms of~          hospitalisation or death as continuing daily cotrimoxazole?~   "
78595|NCT02028663|"~     The purpose of this study is to investigate the optimal dose and administration methods of~     CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally~     administered CJ-12420 to esomeprazole 40mg.~   "
78596|NCT02028650|"~     The relapse leukemia patients after transplantation were divided into two groups randomly.~     Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without~     chemotherapy; group D2: patients received second-donor DSI treatment with or without~     chemotherapy. The second donors were preferably donors who were genetically related and had~     more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone,~     cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide,~     cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and~     no graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.~   "
78597|NCT02028637|"~     Introduction: Recently it has involved the role of TLR (toll-like receptors) in the~     pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of~     Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in~     IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could~     open new therapeutic expectations.~      Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and~     neutrophils in peripheral blood and induced sputum from asthmatic patients~   "
78598|NCT02028624|"~     Aim of the present study was to evaluate the effect of different lifestyle intervention~     administrations, in increasing adherence to the Mediterranean diet in a group of patients~     with RA living in the Mediterranean basin, and, thus, in improving parameters related to~     subjective and objective disease markers, including plasma adiponectin concentrations.~   "
78599|NCT02028611|"~     There were many studies which examined the availability of inverted gray-scale chest X-ray~     for increasing the detection of lung nodules. In emergency medicine, rib fracture is an~     important part for patient's disposition, so investigators designed this study to evaluate~     the availability of inverted gray-scale chest X-ray for the detection of rib fracture.~   "
78600|NCT02028598|"~     The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of~     co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the~     effects after single oral administration in Korean healthy male volunteers.~   "
78606|NCT02028507|"~     This is an international (5 countries) randomized phase III study with 2 cohorts, patients~     will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2:~     fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125~     mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3~     weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous NSAI~     (letrozole or anastrozole) defined as: recurrence while on or within 12 months after the end~     of adjuvant treatment or progression while on or within 1 month after the end of treatment~     for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as~     first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone~     lesions, lytic or mixed, in the absence of measurable disease.~   "
78607|NCT02028494|"~     The purpose of this study is to compare the efficacy of a novel schedule of an oral~     anticancer drug, capecitabine, in patients with metastatic breast cancer.~      Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is~     an optimal dosing schedule for this drug and previous studies done al Memorial Sloan~     Kettering Cancer Center support the tolerability of this scheme.~      This definitive, randomized trial comparing the efficacy of the new dosage with the~     conventional dosing schedule in patients with metastatic breast cancer is necessary and we~     hypothesize it will be superior in terms of efficacy.~      Dosing schedules based on mathematical predictions for optimal drug delivery based on~     efficacy rather than toxicity could facilitate more rapid and economical drug development.~     This trial is a proof of principle trial of the highest priority.~   "
78608|NCT02028481|"~     Macular hole is a hole formation which takes place in the center of the retina. Such a hole~     needs surgical steps in order to close. Closure of the macular hole will lead to a~     substantially improvement of vision in most cases. Following macular hole surgery a~     tamponade of intraocular gas is normally injected in order to keep the macula dry for the~     postoperative period. Postoperative face down position for a week was earlier standard.~     Several authors report of good closure rates with both air tamponade or lack of face down~     positioning. In this study standard pars plana vitrectomy with peeling of the internal~     limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air.~     Postoperative face down positioning will not be used. Only macular holes less than 400 μm~     will be included.~   "
78609|NCT02028468|"~     Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly.~     During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been~     increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a~     MIS approach.~   "
78610|NCT02028455|"~     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For~     this reason, we are attempting to use T cells obtained directly from the patient, which can~     be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T~     cell to recognize and kill the leukemic cell through the recognition of CD19, a protein~     expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a~     phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well~     as to determine the efficacy. The phase 1 cohort is restricted to those patients who have~     already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all~     patients regardless of having a history of HCT.~   "
78611|NCT02028442|"~     This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with~     either solid tumour of epithelial origin not responding to standard therapy or for whom no~     standard treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding~     to standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not~     responding to standard therapy or advanced or metastatic bladder cancer not candidate for~     chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of~     first line standard of care chemotherapy (Phase II).~   "
78612|NCT02028429|"~     The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase~     inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal~     hepatic encephalopathy (MHE) as proposed in different studies.~      This study would also assess the role of improvement of cognition as a means of improvement~     in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.~      This study may prove and provide important therapeutic strategy for cognition impairment in~     patients with MHE.~   "
78613|NCT02028416|"~     Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East~     (Pakistan).~        -  The first treatment option is Allogenic Bone Marrow transplantation which is an~          expansive treatment option and also require a full matched HLA identical donor, hence~          hardly 25% of our affected patients get opportunity for BMT.~        -  The second line treatment option caters a large chunk of patients (severe and~          non-severe AA) along with those who lack HLA identical donor.~      Previously many protocols had been used in past for ATG+CsA Treatment, this treatment~     protocol especially addresses the two different regimens of ATG to study its efficacy,~     durability and long-term effects. Following doses would be used:~        -  CsA+ATG @ 10mg/kg for 3 days~        -  CsA+ATG @ 10mg/kg for 5 days~   "
78614|NCT02028403|"~     People infected with HIV may have low levels of the virus in their body, even if they are~     taking HIV medications. This study will evaluate the safety, pharmacokinetics (PK) (which is~     how the body interacts with drugs), and immune response to BMS-936559, a drug that will be~     administered by an intravenous (IV) infusion, in HIV-infected people receiving combination~     antiretroviral therapy (cART) who have viral load levels below the limit of detection.~   "
78615|NCT02028390|"~     The purpose of this study is to test and evaluate how well a medical imaging device that~     takes both visual and thermal pictures of wounds or body surface areas of interest can help~     collect added information about the wounds or body surface areas of interest in a wound~     clinic.~   "
78616|NCT02028377|"~     This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify~     hidden metastatic disease or identify patients with borderline or locally advanced disease.~   "
78734|NCT02026843|"~     This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic~     factors in the aqueous humor of patients with diabetic retinopathy.~   "
78735|NCT02026830|"~     To determine the causative microorganisms and their antibiotic sensitivity patterns in~     diabetic patients with a foot infection in Turkey.~   "
78617|NCT02028364|"~     This is a prospective, single arm trial in which patients with locally advanced or~     metastatic endocrine receptor positive and HER2 negative breast cancer refractory to~     non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in~     conjunction with exemestane 25mg orally daily until disease progression or treatment~     discontinuation for any other reasons. Tumour, metastatic lesions and blood samples will be~     collected during the treatment period. Genomic analysis on metastatic tumour tissue~     specimens and liquid biopsies will help to identify patients who benefit of this treatment~     regimen. The main objective is to evaluate if early metabolic response (MR) using FDG-PET/CT~     is associated with progression free survival (PFS) this population.~   "
78618|NCT02028351|"~     Purpose of The Study:~      The purpose of this study is the following:~      A)To gather age-related normative visual acuity data for the Vimetrics Central Vision~     Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with~     known ocular problems, including cataract and maculopathy.~      C)To correlate and compare the CVA visual acuity findings with the acuity measured with~     standard LogMAR acuity charts viewed under similar conditions of contrast and lighting~   "
78619|NCT02028338|"~     To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in~     HIV-uninfected adolescent females, when inserted once every 4 weeks during 12 weeks of study~     product use~   "
78620|NCT02028325|"~     The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and~     the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.~   "
78621|NCT02028312|"~     A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel~     0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in~     subjects with dry eye.~   "
78622|NCT02028299|"~     An echocardiogram using Definity contrast can provide the same information as the standard~     right heart catheterization.~   "
78623|NCT02028286|"~     The purpose of this study is to characterize the pharmacokinetics of once daily topical gel~     and confirm that steady state conditions are reached under maximal use conditions following~     3 weeks of daily applications.~   "
78624|NCT02028273|"~     This study is being done to measure the number of brain cells that grow in the brain~     throughout our lives while determining an effective way to complete this with an MRI~     (Magnetic Resonance Imaging) scanner. The number of these brain cells may be affected by~     cocaine use. Researchers are trying to understand the long-term effects of cocaine use on~     the brain.~   "
78625|NCT02028260|"~     This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who~     qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive,~     present gastric access) will either be given 200mg of modafinil or an identical,~     indistinguishable placebo. The placebo and study drug will be distributed by the hospital~     pharmacy. Once enrolled, each patient will be reassessed every morning to determine~     appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or~     greater then 0 modafinil will not be given. He/she will then be assessed each morning~     thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered~     only in the morning. Patients will be assessed for delirium at least twice a day; trained~     personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification~     for a delirium free day will be no positive CAM screens for 24 hours following drug~     administration. Additional data such as days on mechanical ventilation and progression to~     tracheotomy will also be collected hypothesizing that patients who take modafinil will have~     a shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge~     from the unit, but within 48 hours, patients will be asked to participate in a survey (The~     Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and~     nighttime sleepiness in the intensive care unit as well as their overall perception of rest.~     Their functional capacity will also be evaluated at this time and compared to their~     pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony~     in the ICU therefore increasing delirium free days and improving ICU outcomes.~   "
78626|NCT02028247|"~     Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD),~     contributing to substantial distress and impairment. The goal of this study is to examine~     the effectiveness of a personalized type of psychotherapy against standard-care~     psychotherapy for addressing anxiety in youth with ASD.~   "
78627|NCT02028234|"~     Clopidogrel and Prasugrel are pro-drug necessitating conversion in active metabolites~     through CYP 450 system (CYP), particularly CYP3A and CYP2C19 isoforms.~      These drugs are platelet purinergic receptor antagonists, known as P2Y12. The link between~     active metabolite of Clopidogrel and Prasugrel to P2Y12 receptor prevents ADP receptor~     activation and inhibits several events leading to conformational change of platelets,~     therefore facilitating their activation and aggregation, that is the basis of acute coronary~     syndromes. Proton pump inhibitors (PPI) are actually considered principal agents reducing~     gastroenteric bleeding risk associated to antiplatelet therapy. Nevertheless the interaction~     between PPI and antiplatelet therapy has been object of interest. Several studies~     demonstrated PPI reduce efficacy of clopidogrel on platelet reactivity. Only few data about~     Prasugrel are available showing a minor effect of PPI on its antiplatelet activity than~     clopidogrel. Differing from prasugrel and clopidogrel, ticagrelor is a direct inhibitor of~     P2Y12, not necessitating biotransformation in the liver; therefore its interaction with PPI~     remains unclear. Interaction between omeprazole and clopidogrel seems related to high~     inhibitory activity of PPI on CYP2C19, interfering with the conversion of clopidogrel in its~     active metabolite.~   "
78641|NCT02028052|"~     The objective of this study is comparing the attributable procedural time of Endobronchial~     Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and~     hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will~     be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary~     outcomes will include total number of sampled lymph nodes, average number of needle~     aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the~     cytopathologist.~   "
78642|NCT02028039|"~     The goal of this clinical research study is to learn if IPI-145 can help to control the~     disease in patients with ALL. The safety of the study drug will also be studied.~   "
78736|NCT02026817|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and~     co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.~   "
78628|NCT02028221|"~     Overweight and obesity are well established risk factors for breast cancer that develop~     after menopause. The increased postmenopausal breast cancer risk in women who are overweight~     or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a~     commonly used medication in diabetics to stabilize blood sugar. Association studies and~     laboratory studies have shown its potential to reduce the risk for development of cancer,~     including breast cancer. Recent pilot clinical studies in breast cancer patients suggest~     that metformin may only be effective in overweight or obese women with metabolic~     disturbances. We propose to conduct a clinical study of metformin in overweight or obese~     premenopausal women with metabolic disturbances. Study participants will be randomly~     assigned to receive metformin or placebo for 12 months. The study will evaluate whether~     metformin can result in favorable changes in risk features that have been associated with~     increased breast cancer risk. The risk features that will be examined in our study include~     breast density, certain proteins and hormones, products of body metabolism, and body weight~     and composition. The study should help determine the potential breast cancer preventive~     activity of metformin in a growing population at risk for multiple diseases.~   "
78629|NCT02028208|"~     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test~     allergens to the marketed petrolatum reference allergen.~   "
78630|NCT02028195|"~     Check your health is a prevention intervention designed to create awareness and action on~     health condition with focus at physical activity at a population-level to 30-49 years of~     age. It consists of a behavioural and clinical examination followed by either (I) referral~     to a health promoting consultation in general practice (II) targeted behavioural programmes~     at the local Health Centre or (III ) no need for follow-up; stratified after risk-profile.~     The CORE trial (Check your health) aim to investigate effectiveness on health and social~     outcomes of the preventive health check and to establish the cost-effectiveness according to~     life years gained; direct costs and total health costs. A pragmatic cluster randomised~     controlled trial has been established to meet the aims and in total 10.600 individuals from~     35 practices have been randomized in to two groups that will be invited in 2013-14 and~     2017-18 respectively. The group offered the preventive health check in 2013-14 will~     constitute the intervention group and the group examined in 2017 - 18 the control group. A~     follow up of the intervention group in 2017 - 18 will provide data for the intention to~     treat analysis revealing the effect. Outcome measures are level of physical activity, risk~     of getting cardiovascular disease, sick leave and labor market attachment.~   "
78631|NCT02028182|"~     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test~     allergens to the marketed petrolatum reference allergen.~   "
78632|NCT02028169|"~     This post marketing observational study (PMOS) is designed to provide the initial data on~     work impairment of Psoriatic Arthritis (PsA) patients in Turkey, as well as changes in work~     impairment, life quality and clinical response during treatment with anti-TNF agents.~   "
78633|NCT02028156|"~     This is a non-randomized, single-group, multi-center, two phased study to evaluate formula~     intolerance.~   "
78634|NCT02028143|"~     Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of~     Radiofrequency Ablation of Atrial Fibrillation~   "
78635|NCT02028130|"~     Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces~     the quality of life of large numbers of people in the UK and around the world. Catheter~     ablation is a minimally invasive treatment that has been developed to help eliminate AF.~     Recent studies have identified that a particular area of the heart, namely the left atrial~     appendage (LAA), which is a pouch in the left atrium (small collecting chamber of the~     heart), may be the main source of AF in many cases. There is a clear lack of knowledge about~     the structure, anatomy, function and electrical properties of the LAA, which is fundamental~     to furthering our understanding and management of AF.~      In addition, it is well known that AF significantly increases the risk of stroke. The~     majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most~     effective treatment to minimise the risk of stroke has been to thin the blood with agents~     such as warfarin. This therapy requires regular blood tests at much inconvenience to~     patients and increases the risk of bleeding complications. Recently, a large study~     demonstrated that use of an implanted device (Watchman®) to occlude the LAA is as effective~     as warfarin in preventing stroke and confers a lower mortality rate.~      We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a~     Watchman® device during the same procedure in patients who are in atrial fibrillation all of~     the time.~   "
78636|NCT02028117|"~     This study is a phase I/II open label clinical study in patients with platinum-resistant~     epithelial ovarian cancer. The Phase I part of the study will determine the dose of~     enadenotucirev to be recommended for further studies and will examine primarily the safety~     and tolerability but also the pharmacokinetics of administering enadenotucirev~     intraperitoneally. Once the dose of IP enadenotucirev to be used in combination with IV~     weekly paclitaxel has been determined, the phase II stage will begin as an open label dose~     expansion of that regimen. The phase II stage aims to determine whether intraperitoneal~     enadenotucirev has a risk benefit profile that supports further investigation in the~     treatment of patients with platinum-resistant epithelial ovarian Cancer.~   "
78637|NCT02028104|"~     The purpose of this study was to study the effect of stem cell therapy on common symptoms in~     patients with Traumatic Brain Injury~   "
78638|NCT02028091|"~     Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial~     hypertension theoretically changes pulse wave velocity.~   "
78639|NCT02028078|"~     Primary objective is to investigate the feasibility and stability of determining the~     endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus~     subjects by a stable tracer to tracee ratio with an enrichment of 4% and a variation below~     +/-30%.~      Population: twenty type 1 diabetic subjects~      Study design: Single-center, open, non- randomized, pilot-study~   "
78640|NCT02028065|"~     The purpose of this study is to assess the potential for hypersensitivity symptoms upon~     repeat exposure to sugammadex. Healthy participants will be randomized to one of three~     treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will~     receive 3 single intravenous (IV) doses of their randomized treatment, with an approximately~     5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be~     confined at the study center from the day before each dose until completion of the 24-hour~     post dose assessments.~   "
78645|NCT02028000|"~     The study is looking at women undergoing cesarean section delivery of their baby. The~     purpose of this research study is to determine what type of skin closure after cesarean~     section helps decrease pain level the most and improves the appearance of the incision site.~      The study hypothesis is to determine if skin closure with absorbable subcuticular staples~     leads to improved cosmesis and/or decreased post-operative pain.~      Participants in the study will already be scheduled for a cesarean section for delivery of~     their baby. They will be randomized into one of three groups, 1) Insorb (absorbable~     subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their~     cesarean section. Information that will be recorded includes amount of pain medication usage~     while in the hospital after cesarean section, daily patient rated pain score until discharge~     from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks~     after surgery.~   "
78646|NCT02027987|"~     1. Background:~           Preliminary studies have suggested that valproate acid (VPA) may promote neuron~          survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia,~          and promote the brain functional recovery after traumatic brain injury (TBI). Besides,~          in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the~          antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than~          7 days).~        2. Objectives:~           Our main objective was to evaluate whether VPA could protect brain and improve recovery~          of brain function after severe TBI. The secondary objective was to explore whether VPA~          could prevent late epilepsy after severe TBI (more than 7 days).~        3. Methods:~      We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16~     weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly~     assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the~     treatment was discontinued. The rate of functional recovery on the Disability Rating Scale~     (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over~     the 4 weeks of treatment (primary outcome) and during the 2-week washout period with the use~     of mixed-effects regression models.~   "
78647|NCT02027974|"~     The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for~     total hip replacement surgery.~   "
78648|NCT02027961|"~     The purpose of this study is to determine the maximum tolerated dose and the safety profile~     of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in~     subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type~     BRAF, respectively.~   "
78649|NCT02027948|"~     Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss,~     swallowing problems, and poor appetite. This may affect their ability to tolerate cancer~     treatment.~      The purpose of this study is to see if the researchers can apply a set of nutrition~     guidelines designed specifically for patients with cancer who are older than 65 years of~     age. The questions will allow them to assess the nutritional status and make appropriate~     referrals. If the patients are having swallowing problems or losing weight, the researchers~     want to address the nutritional problems early in the course of their treatment.~   "
78650|NCT02027935|"~     The goal of this clinical research study is to learn about the safety of giving CD8+T cells~     with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if~     this combination can help to control metastatic melanoma.~      This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part,~     blood cells will be collected from you to be made into modified CD8+T cells and given back~     to you in the treatment part.~      CD8+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,~     and they are designed to find melanoma cancer cells and may kill them.~      Ipilimumab and aldesleukin are designed to increase the immune system's ability to fight~     cancer.~      Cyclophosphamide will be used at a very low dose to weaken the body's natural defense~     against the T-cell transplant, so that the transplanted T-cells have a chance to grow and~     multiply.~   "
78651|NCT02027922|"~     The study is to compare the prophylactic and therapeutic clinical effectiveness of two~     fluoride varnishes in children at high caries risk.~      It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with~     deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation~     of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly~     to what occurs after the use of Duraphat varnish (C).~   "
78652|NCT02027909|"~     Providing ideal rate response to patients should improve their quality of life and ability~     to execute activities of daily living.~      Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to~     specify an activities of daily living (ADL) response rate and an exertion response rate.~     There is much data to support the target heart rate for an exercise response but the data to~     support the programming of the ADL rate is lacking.~   "
78653|NCT02027896|"~     HIP ATTACK is an international randomized controlled trial of 1200 patients with a hip~     fracture that requires a surgical intervention. This trial will determine the effect of~     accelerated medical clearance and accelerated surgery compared to standard care on the~     30-day risk of a major perioperative complication (i.e., a composite of mortality, nonfatal~     myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis,~     nonfatal stroke, and nonfatal life-threatening and major bleeding).~   "
78654|NCT02027883|"~     As the indications for Implantable Cardioverter Defibrillator implantation expand,~     minimizing implant time is critical. Also, patients receiving biventricular ICDs are~     sometimes more unstable and minimization of sedation time is crucial. Multiple induction~     attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting~     the number of attempts will allow for better lead stability throughout the procedure and a~     more straightforward implant process.~      Investigator proposes a detailed documentation of success rates from various Ventriculart~     Fibrillation induction methods during implant of Medtronic defibrillation capable devices.~   "
78655|NCT02027870|"~     The study aims to further assess the safety, efficacy and the performance of its delivery~     system of the new generation Sirolimus-eluting stent of JWMS up to five years.~   "
78737|NCT02026804|"~     The purpose of this study is to find the incidence of mental disorders during different~     periods of pregnancy and its associated factors and consequences.~   "
78738|NCT02026791|"~     Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a~     supraglottic airway device is widely used because it has advantages such as manipulation of~     the device when inserting it is easier than that of an endotracheal tube and it causes less~     postoperative sore throats. Insertion of an LMA can be performed relatively easily and~     safety at an appropriate depth of anesthesia when compared with the insertion of an~     endotracheal tube because an LMA is inserted without using a laryngoscope and without~     causing stimulus to the vocal cords and the trachea. Hence, an LMA may be useful in cases of~     coronary artery disease and a carotid endarectomy where stabilization of the cardiopulmonary~     function is important. In addition, an LMA is hemodynamically stable not only in the~     induction of anesthesia but also in the arousal of anesthesia and thus less dangerous to a~     cardiovascular disease patient. LMA may be useful also to patients having chronic~     obstructive lung disease because the patients have an excessively sensitive airway and~     ventilation is difficult to perform in them. Therefore, in elderly patients having a~     prevalence for cardiovascular disease or chronic obstructive lung disease, use of an LMA,~     which stimulates the airway less, may provide hemodynamical stability and reduce relevant~     complications or side effects. LMA Supreme which is newly designed in such ways has been~     proven to be superior to the conventional LMA Classic in terms of easy insertion and~     oropharyngeal sealing. A study which compared LMA Classic and LMA Supreme with adult~     subjects showed that LMA Supreme had a superior insertion success rate and better~     oropharyngeal leak pressure (OLP) than those of LMA Classic. Another newly developed~     supraglottic airway device is I-gel. In I-gel, which is a disposable, latex-free LMA, a~     soft, gel-type cuff made of a thermoplastic elastomer replaces the inflatable cuff of other~     LMAs. Thus, I-gel has an advantage that, once it is installed, it requires no additional~     clinical manipulation such as cuff inflation or cuff pressure monitoring. A comparison of~     I-gel with LMA Classic and other disposable supraglottic airway devices produced by various~     manufactures in adult subjects showed that the clinical properties were similar with respect~     to easy insertion, time required for installation, laryngopharynx leak pressure, and degree~     of glottis exposure observed with a fiberoptic bronchoscope. Thus, I-gel is expected to be a~     supraglottic airway device which may replace the conventional LMA Classic. The elderly are~     known to have an upper airway anatomically different from that of younger adults depending~     on age. A study conducted with CT showed that normal elderly people had a wider upper airway~     than that of younger males or middle-aged males and that elderly with accompanying sleep~     apnea had a wider upper airway than that of younger males in all regions including the~     nasopharynx, oropharynx, and hypopharynx. Therefore, because the upper airway of the elderly~     is wider and longer, a different supraglottic airway device guide may be necessary. Our~     previous studies showed that the single time success rate was significantly lower, the~     insertion was more difficult, and the insertion took a longer time when the LMA classic was~     used in elderly patients than in younger adult patients. However, there is no available~     guide for the use of a supraglottic airway device or for a supraglottic airway device more~     appropriate for elderly patients. Moreover, no study has been ever conducted with regard to~     such a guide.~      Therefore, in this study, the clinical usefulness of I-gel and LMA Supreme, which are the~     newest supraglottic airway devices, was verified in elderly patients. It was also verified~     which of the two devices is better to use as a supraglottic airway device.~   "
78656|NCT02027857|"~     Brain edema is the main reason for the disability and lethality in traumatic brain injury,~     which is the most difficult part of emergency rescue. Recently, there is no medical~     equipment to monitor the early brain edema in clinic. We have found that Electrical~     impedance tomography (EIT) can perform the real-time and bedside monitoring of brain~     electrical impedance after single-dose mannitol treatment, which may be a new strategy for~     the surveillance of brain edema. In this study, we would like to compare the application in~     traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring,~     including the progress of brain edema, the relationship between impedance and ICP, and the~     improvement for the patients' prognosis. EIT would probably be a new image strategy for the~     treatment of traumatic brain injury.~   "
78657|NCT02027844|"~     Nearly 50% of young children undergoing surgery exhibit high level of anxiety during~     induction of anesthesia because of exposure to unfamiliar environment and people and~     separation from parents. Increased preoperative anxiety may impact postoperative behavior~     changes such as emergence agitation, separation anxiety and sleep disturbance. Although some~     pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during~     induction of anesthesia, previous studies have reported conflicting results. Recently the~     distraction using video game or animated cartoon has been reported to reduce anxiety of~     young children during induction of anesthesia. However, it was still undetermined whether~     distraction has its own ability to reduce children's anxiety separated from parental~     presence because they evaluated the effect of video method in the parental presence. The~     investigators design to investigated the efficacy of distraction with watching cartoon,~     parental presence and combined with watching cartoon and parental presence on reduction of~     anxiety during inhalational induction of anesthesia using sevoflurane. In addition this~     study includes long-term effect of each intervention such as postoperative emergence~     agitation and postoperative behavior change in children.~   "
78658|NCT02027831|"~     The purpose of this study is to determine if NIR fluorescent imaging is an effective~     approach to detect the margins of head and neck tumours or lymph nodes draining the tumour~   "
78659|NCT02027818|"~     We will observe if ICG fluorescence correlates with margins of breast tumours after iv~     injection of the contrast agent~   "
78660|NCT02027805|"~     In this study, a combination of two antibodies both conjugated to a cell-killing toxin~     (so-called immunotoxins) will be evaluated. The antibodies are directed against T-cell~     antigens 'cluster of differentiation 3 antigen' (CD3) and CD7. Previous in vitro studies~     have demonstrated that this particular immunotoxin-combination, named T-Guard, acts~     synergistically in eliminating T cells with a preference for killing activated T-cells. In a~     subsequent clinical pilot-study, T-Guard has generated encouraging results when applied as~     third-line therapy for patients suffering form steroid-resistant acute Graft-versus-Host~     Disease (GVHD). Extensive biological and clinical responses could be noted in the absence of~     severe acute toxicities. Building on these results, the current study aims at evaluating the~     safety and efficacy of T-Guard for treating steroid-resistant GVHD when administered in an~     earlier phase of the disease process, i.e. as second-line instead of as third-line therapy.~   "
78661|NCT02027792|"~     This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms~     in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be~     randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel~     daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire~     on pain, disability, quality of life and pressure pain sensitivity.~   "
78662|NCT02027779|"~     This study primarily will address the safety and secondarily will assess efficacy of~     GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with~     a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).~   "
78663|NCT02027766|"~     Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and~     to prevent sports injuries. It is not known if stretching affects pain sensitivity. The~     purpose of this study is to investigate if a 4 week daily stretching protocol alters pain~     sensitivity.~      The investigators hypothesize that stretching reduces pain sensitivity.~   "
78664|NCT02027753|"~     Primary Objective:~      To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin~     glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea~      Secondary Objectives:~        1. To assess the efficacy by adding insulin glargine~        2. To assess insulin dose~        3. Safety~   "
78665|NCT02027740|"~     This prospective cohort study of an almond-enriched diet (within the overall context of~     Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with~     T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.~   "
78666|NCT02027727|"~     The purpose of this study is to determine which early infliximab pharmacokinetic level is~     most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.~   "
78667|NCT02027714|"~     The purpose of this study is to gather information needed to develop a large prevention~     trial to decrease the risk for HIV transmission among HIV-discordant couples (where one~     person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would~     like to learn more about men, women and couples in Lesotho and what they think about various~     topics related to HIV, including HIV testing and counseling, male circumcision and HIV~     treatment.~      There will be three parts to the study including 1) a survey 2) focus group discussions; and~     3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited~     to participate in the survey. Women who answer the questionnaire will also be asked to~     participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be~     conducted. Thirty men from the community will be recruited to participate in an in-depth~     individual interview.~   "
78678|NCT02027571|"~     The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain~     populations suffer at higher rates are not well known. In the Pathobiology and Reversibility~     of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and~     Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine~     what factors lead to the occurrence of prediabetes, and whether race still plays a major~     role in a setting where everyone being studied has one or both parents with diabetes. The~     PROP-ABC Study also will test the hypothesis that the ability of intensive lifestyle~     intervention to reverse prediabetes and return people's metabolism back to normal is~     dependent on how long people have had prediabetes.~   "
78668|NCT02027701|"~     This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The~     purpose of this extension study is to investigate the long-term treatment of CIDP with~     IgPro20, with regard to safety and efficacy.~      Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a~     CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will~     have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for~     up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose~     IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.~     Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed~     a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP~     relapse within 4 weeks, they will be withdrawn.~      The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).~   "
78669|NCT02027688|"~     Preterm infants face many feeding challenges during hospitalization which can prolong~     hospitalization, raise parental anxiety and can lead to medical instability. The Feeding~     Progression study will randomize preterm infants to one of two currently accepted oral~     feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect~     data on oral feeding success, milk transfer, sucking strength, growth and medical~     complications.~   "
78670|NCT02027675|"~     In a society where exercise is prescribed by physicians to increase physical condition,~     improve dietary habits and reduce cardiovascular risk, the impact of exercise, acute or~     chronic, and diet in inflammation and immunity is unknown. Specific populations can have~     different responses towards acute and chronic exercise. Moreover specific conditions, like~     the type of meal ingested, can interfere with these responses. The true effect of~     pre-competitive meal exercise in the immunity and inflammatory response is unknown. Acute~     physical inactivity periods, commonly happens during daily life, related to work or acute~     illness. New evidence points out that it induces immediate metabolic and endocrinological~     changes, these can might also be associated with changes in immune response.~      Aims of this project are:~        1. to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and~          metabolic response to exercise;~        2. to assess the effects of sedentary behaviour on inflammatory, neuro-immune and~          metabolic response;~        3. to assess differences in changes between healthy, asthmatic and obese subjects~   "
78671|NCT02027662|"~     Phosphate binders are crucial to the control of elevated phosphate levels in patients with~     chronic kidney disease. With the new formulation of granules the pill burden of patients is~     sought to be reduced.~      This study is about efficacy and safety of the new drug formulation and compares it to the~     old formulation which are film-coated tablets.~   "
78672|NCT02027649|"~     By an invasive technique keratin 14 has been identified as a prognostic factor in bladder~     cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can~     be used as a diagnostic and prognostic marker for this cancer.~   "
78673|NCT02027636|"~     Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care~     manager intervention offered either by telephone or face-to-face with depressed Latinos~     identified in primary care. Eligible patients were randomized after baseline to one of three~     conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and~     3) usual care. Usual care was considered care as usual in the participating clinic for a~     patient screening or depression. The ECLA-T intervention was based on a~     telephone-plus-care-management intervention that has been shown to be effective in~     decreasing depressive symptoms and increasing client satisfaction and self-perceived global~     improvement, as compared to usual care in depressed patients in primary care settings.~   "
78674|NCT02027623|"~     Exercise is one of the primary interventions used with people with chronic, mechanical low~     back pain. It is unknown, however, which exercise is best for which person, which exercises~     a person will adhere to and for how long, and the effect of adhering to a specific type of~     exercise on how the person functions, particularly in the long run. The purpose of this~     study is to examine if the short- and long-term effects are different between 1) commonly~     prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized~     practice in daily functional activities that are difficult or painful to perform. Adherence~     to the different interventions, the relationship between adherence and outcomes,as well as~     the effect of a booster intervention also will be examined.~   "
78675|NCT02027610|"~     Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young~     children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation~     (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common.~     Such countries include Bangladesh, where this study is being conducted. While providing VAS~     at 6 months is recommended, providing VAS at birth may also decrease the risk of death since~     newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by~     improving the immune response to infection and immunization. Vitamin A particularly affects~     the development and function of T cells, which develop in the thymus and are a key component~     of the memory response to infection and immunization. Vitamin A is important for development~     of an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells~     prevent over-reaction of the immune system to substances the immune system might otherwise~     treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt~     the normal colonization of the infant's intestinal tract and cause a condition called~     dysbiosis where abnormal bacteria flourish and adversely affect the infant's immune~     system. Dysbiosis may disrupt the immune response to injectable and oral vaccines. VAS at~     birth may prevent dysbiosis and thus improve immune function, response to vaccines, and~     child survival. The investigators recently completed an intervention trial in Bangladeshi~     infants (NCT01583972) examining the effect of VAS at birth on immune function and response~     to vaccines administered from birth to 14 wk of age. The present study will recruit infants~     who completed NCT01583972 when they are from 12 to 24 m of age to determine if VAS at birth~     affects the responses to these same vaccines when they are measured during the second year~     of life. The investigators will examine the effect of VAS at birth on gut microbiota~     measured early in infancy and during the second year of life, and explore the association of~     the gut microbiota with vaccine response. Mothers of study infants will participate in the~     study because the breast milk oligosaccharide content strongly affects gut microbiota~     composition and the secretor status of the mother, which can be determined from maternal~     FUT2 genotype, strongly affects breast milk oligosaccharide content.~   "
78676|NCT02027597|"~     This study investigated if computer games can be effective at changing the way children take~     care of their teeth. We a museum exhibit with 3D virtual reality games called Attack of the~     S. Mutans! Our hypothesis was that children who played the games and visited the exhibit~     would show improved attitudes about oral health, which would translate into improved~     brushing and self-care habits.~      In this randomized controlled study with school children aged 8-12, we compared the outcomes~     for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on~     classroom presentation about virtual reality being used for healthcare; Group 3) Received~     no-treatment.~   "
78677|NCT02027584|"~     To study concentrations of choline, its metabolites, and phospholipids in cord blood and~     remnants of clinically indicated blood samples~   "
78680|NCT02027545|"~     Systematic efforts to improve colorectal cancer screening use in the VA Healthcare System~     have resulted in an increase in not only appropriate, but also inappropriate use of~     screening. The purpose of this study is to test a new, more patient-centered approach to~     colon cancer screening. In older individuals (ages 70 to 75) who are due for screening,~     the investigators will provide education on the benefits and harms of colon cancer~     screening. But instead of simply providing these patients with average information about~     these benefits, the investigators will give them information that takes into account their~     personal characteristics (e.g., age, gender), overall health, and screening history and~     therefore applies to them more personally. The investigators will also work with the health~     system to create time and space for patient and doctor to discuss whether screening is the~     right choice for each individual. This way, patients can make an informed choice about what~     is right for them, with the help of their doctor. In the future, the results of this study~     will help patients make more informed screening decisions, especially when the benefits of~     screening may be uncertain for them personally.~   "
78681|NCT02027532|"~     The purpose of this study is to compare the incidence rate of infection in surgical patients~     with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the~     peri-operative period.~      The hypothesis of this study is that patients undergoing surgical treatment for closed~     fractures who are treated prophylactically with Vancomycin will have a lower incidence rate~     of infection than patients who are treated prophylactically with Cefazolin.~   "
78682|NCT02027519|"~     The purpose of this study is to gather information needed to develop a large prevention~     trial to decrease risk for Human Immunodeficiency Virus (HIV) transmission among~     HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in~     Lesotho. The protocol team would like to explore new strategies for increasing the number of~     partners who receive an HIV test and whether this increase in testing also results in~     identifying HIV-discordant couples. These couples would be the focus of the future large~     prevention trial, therefore it is critical that the protocol team explore effective~     strategies for identifying and recruiting these couples. Men and women (index participants)~     who are attending Antenatal Care (ANC),Tuberculosis (TB) and antiretroviral therapy (ART)~     clinics will be recruited for this study. If they agree to take part, a testing team will~     visit their household and offer all adults staying in the house the opportunity to conduct a~     self-test for HIV. Seventy-ﬁve index participants will be enrolled into the study and have~     their homes visited by the testing team. The number of household members tested will depend~     on the number of people living in each household.~   "
78683|NCT02027506|"~     The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a~     well-established role in the diagnosis of (CAD). Many studies have found that the admission~     of ECG provides important prognostic information in patients admitted with chest pain. For~     instance, T wave inversion in anterior or inferior location and or ST-segment depression has~     been associated with high incidence of CAD.~   "
78684|NCT02027493|"~     Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and~     children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or~     -2b and ribavirin have been used in small numbers of hepatitis C virus-infected children~     with sustained virological response being higher in genotypes 2 and 3 than in genotypes 1~     and 4. Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to~     modify treatment protocols have been tried in adults in an attempt to achieve higher rates~     of sustained virological response. Shortening injection interval and/or treatment duration~     prolongation have been tried with variable outcome reports.~      A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard)~     has been used over the last 4 years in the Egyptian market.~      We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized~     regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with~     chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers.~      Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction~     (PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during~     treatment and 6 months after stoppage of treatment. All patients were assigned to receive a~     weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral~     Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2~     groups.~      Group I: Patients who continued treatment on weekly basis: this group included patients who~     had negative PCR at week 12 as well those who had positive PCR without any change in~     viremia. Group II: Patients who continued treatment on a 5- days schedule: this group~     included patients who had any decrease in viremia at week 12.~      Patients who were PCR-negative at week 48 and had at least one PCR-positive test during~     therapy were assigned to have an extended treatment course of 6 months duration.~      The occurrence of adverse effects was assessed during treatment and follow up~   "
78685|NCT02027480|"~     The aim of this study is to develop and follow a cohort of human immunodeficiency virus~     (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and~     urine samples will be collected from all participants in order to establish a sample bank of~     samples in order to further the understanding of the levels of inﬂammatory biomarkers and~     coagulation biomarkers in African patients and the effect of taking HIV drugs on these~     biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs~     and collect blood and urine specimens from them at 4 study visits. These samples will be~     frozen and stored for future testing related to inﬂammatory and coagulation biomarkers.~   "
78686|NCT02027467|"~     Combination of various herbs is known to promote mobilization of hematopoietic stem cells.~     Hence the current study has been intended to study the effect of Stem Alive® on mobilization~     of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are~     known to be used as traditional medicine. They are also tested qualitatively in academic and~     nutritional science research centers throughout the world and which substantially according~     to those studies stimulate the augmented availability of circulating hematopoietic cells.~     This study is projected to investigate the mobilization of stem cells on healthy human~     volunteers.~   "
78687|NCT02027454|"~     This study is being conducted to comply with the Food and Drug Administration (FDA)~     recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization~     effects through electrocardiographic evaluation. Therefore, this study will evaluate the~     effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead~     continuous digital data in healthy adults. This study will evaluate the effect of three~     doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared~     to placebo. Moxifloxacin will be used as a positive control in order to validate the~     sensitivity of the study in detecting QTc change. This study consists of three treatment~     periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days~     post last dosing. The total duration of study including follow-up visit will be~     approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects~     complete dosing and critical assessments.~   "
78688|NCT02027441|"~     The purpose of this study is to gather information needed to develop a large prevention~     trial to decrease risk for Human immunodeficiency virus (HIV) transmission among~     HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in~     Lesotho.~      The protocol team would like to explore new strategies for increasing the number of partners~     who receive an HIV test and whether this increase in testing also results in identifying~     HIV-discordant couples. These couples would be the focus of the future large prevention~     trial therefore it is critical that the protocol team explore effective strategies for~     identifying and recruiting these couples.~      Men and women (index participants) who are attending antenatal (ANC) and Tuberculosis (TB)~     clinics will be recruited for this study. If they agree to take part, a testing team will~     visit their household and offer all adults staying in the house the opportunity to receive~     an HIV test.~      Three hundred index participants will be enrolled into the study and have their homes~     visited by the testing team. The number of household members tested will depend on the~     number of people living in each household.~   "
78689|NCT02027428|"~     Maintenance treatment of advanced stage squamous cell NSCLC~   "
78690|NCT02027415|"~     The study hypothesis is that drinking different juices will affect the body's responses to~     air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ~     (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the~     subject will be asked to drink orange juice. Before the other car ride, the subject will be~     asked to drink beet juice. Samples of blood and exhaled breath will be collected before,~     immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be~     measured in the blood and breath.~   "
78691|NCT02027402|"~     During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely~     insert a drain. However, no consensus has been reached regarding the need for drainage in~     these cases, and the use of a drain remains controversial. This study is coordinated to find~     out the surgical outcomes and perioperative morbidity according to the insertion of drain~     after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain~     after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects~     on the postoperative morbidity.~   "
78692|NCT02027389|"~     The objective of this study is to evaluate the impact of the Alere&#8482; PBP2a test~     combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in~     hospitalized patients with sterile site S. aureus infection.~   "
78693|NCT02027376|"~     This is a single-arm, open-label, phase Ib study. In this trial, patients with Triple~     Negative (TN) Advanced Breast Cancer (ABC) will be treated with increasing doses of LDE225~     and docetaxel to determine the MTD (Maximum Tolerated Dose), DLT (Dose Limiting Toxicity)~     and RP2D (Recommended Phase II Dose) of the combination.~      Eligible patients with hormonal receptors negative and HER2 negative ABC will be included~     and treated with docetaxel intravenously in every three weeks cycles. LDE225 will be~     administered orally at three dose levels 400, 600 and 800mg QD (a -1 dose level is included~     just in case dose de-escalation is needed). Treatment will be repeated on day 1 of a 21-day~     cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws~     informed consent.~      The investigators propose to develop a phase Ib trial with the combination of docetaxel with~     LDE225 in TN ABC patients to define the safety, tolerability and RP2D, as well as to have~     some information about the efficacy of the combination.~      Primary Objective:~      To determine the MTD and RP2D of LDE225 administered orally in combination with docetaxel in~     TN ABC patients.~      Primary End-point:~      To determine the incidence rate of DLT within the first two cycles of LDE225 in combination~     with docetaxel at each dose level.~      Secondary Objectives:~        -  To determine the safety and tolerability of LDE225 given in combination with docetaxel.~        -  To characterize the effects of LDE225 in combination with docetaxel on QTc intervals~          and their correlation with systemic drug exposure.~        -  To evaluate the efficacy of the combination of docetaxel with LDE225 in TN ABC~          patients.~        -  To evaluate the Pharmacokinetics (PK) of the combination of docetaxel with LDE225.~      Secondary End-points:~        -  Safety will be assessed by standard clinical and laboratory tests (hematology, serum~          chemistry). Adverse events grade will be defined by the NCI CTCAE v4.0.~        -  Changes in QT/QTc from baseline ECG values and correlation with systemic drug exposure.~        -  The efficacy endpoints are Time To Progression (TTP) and Objective Response Rate (ORR).~          TTP is measured from the initiation of treatment till disease progression and ORR is~          defined by RECIST 1.1 criteria as complete response rate + partial response rate.~        -  The PK will determine whether LDE225 influences the pharmacology of docetaxel. Blood~          samples will be taken at the times defined in the protocol.~      Exploratory Objectives:~        -  To study potential predictive biomarkers of efficacy by evaluating activation of Hh~          signaling pathway and related pathways.~        -  To analyze the pharmacodynamic (PD) treatment effects on the expression of Smo related~          biomarkers and Hg target genes in correlative samples.~        -  To correlate biomarker, PD and PK findings with efficacy and toxicity data.~      Exploratory End-points:~        -  Hh gene expression signature associated to pathway activation (at least Shh, Smo,~          Ptch1, Ptch2, Gli1, Gli2), analyzed in tumor samples.~        -  Changes in Smo related pathway biomarkers (at least Gli1) in skin and blood correlative~          samples.~        -  Pharmacodynamic and biomarker analysis results will be correlated with PK findings,~          efficacy and toxicity data.~      Demographics and Baseline Characteristics:~      Standard descriptive statistics, such as the mean, median, range and proportion, will be~     used to summarize the patient sample and to estimate parameters of interest. Ninety-five~     percent confidence intervals will be provided for estimates of interest wherever possible.~      Safety Analyses:~      Adverse events data and serious adverse events will be reported in frequency tables (overall~     and by intensity). The safety analysis will be performed in the population that has received~     at least one dose of the drugs.~      Efficacy Analyses:~      Response will be analyzed in patients with measurable disease that have received at least~     one dose of the drugs.~      TTP will be evaluated in all patients that have received at least one dose of the drugs.~      Study population:~      Patient with hormonal receptors negative and HER2 negative ABC.~   "
78694|NCT02027363|"~     Colorectal cancer is one of the most common malignant tumors, with the morbidity of~     approximate 100 million cases per year. About 40% of patients present with metastatic (stage~     IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion~     will ultimately develop metastatic disease.~      5-Fluorouracil（5-FU) was the only efficacious treatment for metastatic colorectal cancer~     before the nineties of the 20th century, and afterwards as the discovery of chemotherapy~     such as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been~     improved greatly.~      Most of advanced colorectal cancer will progress after first-line treatment; therefore,~     seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in~     oncologic field. Some clinical researches demonstrated that maintaining treatment followed~     first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer,~     patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer~     PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase~     II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients~     receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining~     treatment . A non-randomized small sample study conducted in department of medical oncology~     of Sun Yat-Sen University Cancer Center indicated that patients receiving first-line~     treatment of XELOX followed by capecitabine as maintaining therapy has significantly~     prolonged median TTP, comparing with the non-maintaining treatment patients,(14months vs. 9~     month, respectively).~      Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy~     followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer.~     Capecitabine is effective for colorectal cancer, and was approved as palliative treatment~     for advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative~     less frequency of side effects and convenient oral administration, capecitabine as~     maintaining regimen could be prone to be accepted by patients. Therefore, our study is~     designed to investigate that capecitabine as maintaining treatment after first-line~     palliative chemotherapy could improve TTP and OS for patients with advanced colorectal~     cancer through a perspective randomized clinical study.~   "
78695|NCT02027350|"~     Until now, diagnosis of constriction was based on pressure changes of ventricle by~     conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This~     study will provide answers to persisting questions about volume changes during respiration~     in patients with constrictive pericarditis by directly measuring both right and left~     ventricular volume.~   "
78696|NCT02027337|"~     We investigate parameters of hemocoagulation and lipoperoxidation in women using combined~     oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg~     ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants~   "
78697|NCT02027324|"~     There are approximately 1.4 million cesarean deliveries in the United States each year, and~     an average of 1250 elective cesarean deliveries each year at the Brigham and Women's~     Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH,~     approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI~     is associated with significant morbidity and increased cost of care, numerous guidelines~     exist to guide preoperative administration of prophylactic antibiotics. However, there are~     no recommendations for the choice of antiseptic solution for prevention of SSI. Among the~     currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease~     SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to~     minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery.~     Many institutions use povidone-iodine, another antisepsis preparation that does not require~     the mandatory drying time. Our randomized study aims to compare the incidence of SSI in~     patients receiving either CA or PI during elective cesarean delivery, and we hypothesize~     that CA would be associated with a lower incidence of SSI.~   "
78698|NCT02027311|"~     Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A~     receptor has been known that it maintains the appropriate sedative levels and affects little~     effects on respiratory system.~      The investigators are now trying to investigate that etomidate with meperidine combination~     regimen is superior to the midazolam with meperidine more effective and less harm on~     sedation during the ERCP procedure.~   "
78699|NCT02027298|"~     The primary purpose of this pilot study is to evaluate the efficacy and safety of Abatacept~     in subjects with Sjogren's Syndrome (SS). This clinical trial study will enroll and treat 15~     subjects with active moderate and severe inflammatory arthritis associated with primary~     Sjogren's syndrome (pSS) and secondary Sjogren's sybdrine (sSS) with Rheumatoid Arthrits~     (RA). All subjects will receive Abatacept weekly by Subcutaneous (SC) dosing. Subjects will~     receive Abatacept by SC injection of 125 mg on day 1 and followed by 125 mg SC weekly~     thereafter.~   "
78700|NCT02027285|"~     The study Nutritional trial with fortified milk in 65+ years old subjects is a part of a~     complex research project and multi-sectoral development (MIAO 50) with the participation of~     University Research Institutes and small and medium Italian enterprises.~      The general objective of the call is to promote the collaboration between the best~     scientific knowledge, both epidemiological and experimental, and the most advanced~     technologies to develop foods with a nutritional profile adequate to the needs of consumers~     with an age over 50 years old, which are easy to use and make it possible to eat in a~     healthy manner, complete and balanced and also meets the quality and flavors of traditional~     Italian.~   "
78701|NCT02027272|"~     This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more~     quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome~     (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo~     or steroid will receive standard therapy to include magnesium sulfate, blood pressure~     medications and diuretics. We hypothesize that the addition of dexamethasone to standard~     therapy will accelerate CNS recovery more quickly than standard management without~     dexamethasone.~   "
78702|NCT02027259|"~     The purpose of this study is to determine whether group visits with added behavioral~     activation (BA) for depression will have a greater clinical impact than our standard group~     visits without BA for depression in reducing the risk of future coronary events as measured~     by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms~     as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.~   "
78703|NCT02027246|"~     The aim of this study was to study the effect of stem cell therapy on common symptoms of~     spinal cord injury patients.~   "
78704|NCT02027233|"~     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised~     with laboratory-confirmed influenza through a network of hospitals in France.~   "
78705|NCT02027220|"~     RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity.~     Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma~     cells by stopping them from dividing or by killing the cells. Granulocyte Clone Stimulating~     Factor (G-CSF) possesses the ability to mobilize the plasma cells to detach from myeloma~     niche, so as to promote drug sensitivity.~      PURPOSE: This phase Ⅱ trial is to study how well combination of G-CSF, bortezomib,~     cyclophosphamide and dexamethasone works in treating patients with multiple myeloma.~   "
78706|NCT02027207|"~     Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional~     epidemics seen during times of floods, cyclones or any natural disaster. It affects all age~     groups with the majority of fatal cases occurring in children . Therefore, immunization~     against cholera remains an important public health component in the prevention and control~     of the disease .The current two-dose regimen of the internationally available oral cholera~     vaccines (OCV) create a logistical and programmatic challenge for use in national programs~     or during epidemics ,so it is important to determine if a single dose vaccine will be~     protective in regions where cholera is endemic. If the vaccine is found to be efficacious~     following a single dose, this will have profound implications for the use of the vaccine in~     areas with limited resources particularly in complex emergencies where a multiple dose~     regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its~     'field ability' and allow the vaccine to be used for outbreak control, especially in~     difficult settings where the risk of cholera is extremely high and provisions for clean~     water and sanitation are not available. With low OCV production rates, larger populations~     could be immunized against cholera if a single dose is found to be efficacious. A~     single-dose schedule could facilitate the inclusion of a global stockpile strategy.~      The study design is a two-arm individually randomized double-blind placebo-controlled trial.~     The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or~     placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study~     treatment centres from 7 days to 6 months after dosage and whose identity is confirmed~     through home visit.~   "
78707|NCT02027194|"~     The aim of this study is to test and compare the effectiveness between three groups -~     Cure-Allergic Rhinitis Syrup (CS), Yuk ping fung San (YS) and placebo groups - of~     adolescents (nursing students) with Allergic Rhinitis (AR) in improving their symptoms of~     AR, body constitution pattern and health-related quality of life.~      • The hypothesis are to test the effectiveness of the CS treatment on these students' AR~     symptoms and quality of life at immediately, one month and two months after completion of~     the 4-week intervention, when compared with the YS treatment and placebo group.~        1. Cure-Allergic Rhinitis Syrup (CS) group will show significantly reduction of AR~          symptoms over the 2-month follow-up, when compared to those in YS and placebo groups.~        2. CS group will indicate a healthier body constitution pattern over the follow-up, when~          compared to those with YS and placebo group.~        3. CS group will indicate significantly greater improvement of their quality of life over~          2-month follow-up, when compared to those with YS and placebo group.~   "
78708|NCT02027181|"~     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver~     automatically oxygen in the emergency department in a patient population admitted for acute~     respiratory failure.~      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses~     and medical personnel and there are advantages to use this system. In comparison with the~     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a~     better control of the oxygen saturation in function of designed target, reducing the~     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical~     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse~     personnel.~   "
78709|NCT02027168|"~     This study will examine the impact of manual physical therapy on endocrine function in women~     diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10~     mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual~     physical therapy will decrease FSH levels.~   "
78710|NCT02027155|"~     This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV~     doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.~   "
80263|NCT02006849|"~     The purpose of this research study is to determine if the study drug H.C. Acthar gel slows~     the progression of your kidney disease. This drug is a steroid-based medicine with fewer~     side effects than other steroids used for treatment of kidney diseases similar to APOL1~     nephropathy.~   "
78712|NCT02027129|"~     Recent data from large trials of high-frequency high frequency oscillation (HFO) without a~     cuff leak vs, lung-protective conventional ventialtion (CMV) failed to show any HFO-related~     benefit with respect to outcome. A possible explanation is that HFO increases the~     probability of right ventricular dysfunction due to the combination of high mean airway~     pressures (mPaws) and hypercapnia. In contrast, available preliminary data on low-frequency~     HFO-tracheal gas insufflation (TGI) with cuff leak vs. CMV are suggestive of an HFO-TGI~     related benefit. Low-frequency HFO-TGI with a cuff leak is associated with relatively low~     mean tracheal pressures and adequate control of PaCO2. Thus, the investigators intend to~     test the hypothesis that low frequency HFO +/- TGI with a cuff leak is associated with~     better right ventricular function relative to high-frequency HFO without a cuff leak.~   "
78713|NCT02027116|"~     To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy~     in chronic hepatitis C patients~   "
78714|NCT02027103|"~     Oral hypoglycemic agents, along with dietary modification and exercise encompass the~     mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two~     major groups of hypoglycemic medications that while function via different pathways, mare~     both effective in short- and long-term glucose control. These medications diminish or delay~     long term micro- and macrovascular complications associated with T2DM although at different~     rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular~     incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in~     atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes~     medications are able to modify successive CAD risk via direct and indirect amelioration of~     insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the~     effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and~     OPG in a group of Iranian adults with newly diagnosed T2DM.~   "
78715|NCT02027090|"~     We hypothesize that higher dose icotinib is related with better efficacy. The primary~     objective is to compare the progression-free survival of higher dose and routine dose of~     icotinib in treating pretreated advanced non-small cell lung cancer patients with stable~     disease after 8-week routine dose icotinib treatment.~   "
78716|NCT02027077|"~     Obesity is a major risk factor for disease and a public health problem. Recent information~     suggests that while it is possible for most overweight adults to lose a substantial amount~     of weight, maintaining the weight loss for any extended time (2 to 3 years) is very~     difficult. This is because trying to maintain big changes in exercise and/or eating~     behaviour is very difficult in today's environment that makes sustain big changes in~     behaviour (Example: eat allot less or exercise allot more) very hard. In fact at this time~     health professionals are unsure of how best to help overweight adults maintain big~     behavioral changes for long periods of time. In response, we propose that making smaller~     changes in eating and exercise habits every day may be possible in today's environment and~     if so, small weight changes may be possible to maintain for long periods of time. This study~     is designed to assess whether making small changes in eating and exercise behavior will be~     associated with sustained weight loss over three (3) years. The results of the study may~     have important implications for development of public health messages and clinical~     guidelines for prevention and treatment of obesity through small changes in both exercise~     and eating habits.~   "
78717|NCT02027064|"~     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell~     transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.~      Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.~      the study is to evaluate the safety and efficacy of interferon for the intervention of~     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell~     transplantation (allo-SCT)~   "
78718|NCT02027051|"~     This study aims at better understanding the genetic structure of the Armenians, an old~     population whose genetics has not been the subject of many studies. We will study 500~     individuals whom grandparents originate from different regions of Armenia. Each individual~     will be genotyped using a large panel of genetic markers. Principal component analysis will~     be used to analyze the genetic structure of this population.~   "
78719|NCT02027038|"~     Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of~     limb muscles and ground reaction forces are different in patients with sacroiliac joint~     pain, as compared to healthy controls.~      Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the~     electromuscular activation of the limb muscles or ground reaction forces.~      Hypothesis III: The effects proposed in hypothesis II are different in patients with~     sacroiliac joint pain, as compared to healthy controls.~   "
78720|NCT02027025|"~     Study of SPARC1103 in subjects wirth spasticity~   "
78721|NCT02027012|"~     REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the~     percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary~     objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for~     the treatment of medication resistant hypertension on the basis of the hypothesis that the~     percutaneous therapeutic renal denervation for the treatment of medication-resistant~     hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and~     diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based~     blood pressure measurements.~   "
78722|NCT02026999|"~     The purpose of this study to determine the effectiveness of sugammadex in septoplasty~     patients whose mask ventilation would be difficult after extubation.~   "
78739|NCT02026778|"~     Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea~     and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as~     ondansetron. Involvement of multiple types of receptors and factors may be a reason for~     inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1~     receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness.~     Dizziness is one of the cause of nausea and vomiting. This study is to compare the effects~     of ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk~     patients receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after~     gynecological laparoscopic surgery.~   "
78740|NCT02026765|"~     The purpose of this study is to obverse the effect of this type lens in the same as~     traditional aspheric intraocular lens at the same time, whether can further improve the~     effects of operation.~   "
78723|NCT02026986|"~     Tear film consists of three layers including outer lipid layer, aqueous layer and inner~     mucin layer.1,2 Lipid layer protects the aqueous layer of tear film from evaporation and~     mucin layer adhere the tear film to ocular surface. Aqueous layer, which is produced in~     lacrimal glands, is the most important in the health of ocular surface. Reduction of aqueous~     tear secretion results in the disruption of homeostasis at ocular surface and leads to dry~     eye syndrome.2 Dry eye syndrome is a common ocular surface disease associated with symptoms~     of eye discomfort, grittness and visual disturbance.1,2 Dry eye syndrome disrupts normal~     homeostasis at the ocular surface resulting in epithelial damage, epithelial cell apoptosis,~     loss of goblet cells, and squamous metaplasia.1-3 The changes and inflammation of ocular~     surface subsequently lead to tear instability, which causes an increased tear osmolarity and~     aggravates the inflammatory cascades. This leads to a vicious cycle.2 The regulation of tear~     film secretion is under neural and hormonal control.4 Dry eye syndrome has been associated~     with diverse and multiple causes, including depressive disorder, drugs, hormonal status, and~     systemic diseases.2 Sleep deprivation (SD) is known to cause profound impair¬ments in~     executive function and vigilant attention.5,6 It is also reportedly associated with~     autonomic and endocrine functioning7-9 and has been shown to increase blood pressure and~     stress hormone levels and decrease parasympathetic tone.10,11 Tear secretion is regulated by~     neurological factors and hormones,12 and so SD may have an effect on the tear film and~     ocular surface. However, only a few studies have evaluated the effect of sleep on the tear~     film and ocular surface.~      In this study, we investigated the effect of SD on the tear film and ocular surface.~   "
78724|NCT02026973|"~     Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by~     potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin~     inhibition of GH release.~   "
78725|NCT02026960|"~     The primary objective is to evaluate methods for AGS-003 production from surgical (stage I)~     and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU~     cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other~     GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from~     total tumor RNA isolated from tissues obtained by core needle tumor biopsy.~   "
78726|NCT02026947|"~     The aim of this study is to investigate whether sodium benzoate is superior to placebo in~     decreasing symptoms among patients with attenuated/transient psychosis. A total of 140~     patients will be randomized in 1:1 ratio to receive sodium benzoate 1 g/day or placebo for~     12 weeks. Concerning statistical power, the number of patients is sufficient to obtain~     statistical significance for a clinically meaningful effect size of 0.40 (Cohen's d). The~     primary outcome measure is change in PANSS sum score of delusions, hallucinations,~     suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria)~     at week 12. Change in CGI score at week 12 is the other primary outcome measure. The~     secondary outcome measures are change in PANSS total score at week 12, CGI score at week 24,~     and GAF at weeks 12 and 24.~   "
78727|NCT02026934|"~     CliniMACs is an investigational device used to select and enrich stem cells. The device will~     select the stem cells with CD34+ protein. The participant will be infused with the CD34+~     selected cells in the hopes that it will help the participant engraft. Engraftment is when~     transplanted stem cells resume production of healthy blood cells.~   "
78728|NCT02026921|"~     A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive~     relapse of epithelial ovarian, peritoneal or tubal cancer.~      Hypothesis: Treatment with this combination in second line is safe and with a low frequency~     of neurologic side effect.~   "
78729|NCT02026908|"~     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate~     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to~     benign prostatic hyperplasia (BPH).~   "
78730|NCT02026895|"~     The main objective is to identify new virulence factors produced by Staphylococcus~     lugdunensis that can be associated with clinical sign of severe infections and identified~     symptoms. The methodological approach is based on the comparison between the production of~     toxins by a given S. lugdunensis isolate classified in patients groups according to the~     infection clinically defined. Each group will be compared to the presence or not of studied~     virulence factors. Clinical features associated with toxin activity are not known for S.~     lugdunensis. This comparative approach is based on the hypotheses that drove to the~     definition of patient groups and their clinical criteria. However, in the absence of the~     evident correlation between production of toxins and kind of infection, the statistical~     evaluation will be completed by a multi-varied analysis. This approach has not been choosen~     first because of the multiple parameters that undergo during infection that may reveal~     relationships without true correlation. About the number of included patients in each~     defined group, if one of them does not reach the expected count, we still might extend~     inclusions to 3-6 months more. The presence of severe infections without usually defined~     risk is intriguing. For these last patients, we have planned, after their individual consent~     to achieve an exome sequencing. The obtained data will be compared to available resources~     for the human genome. By filtering data through usual protocols, we hope to able to focus~     onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due~     to S. lugdunensis without defined risk.~   "
78731|NCT02026882|"~     The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a~     good seal for positive pressure ventilation and good first attempt insertion rate of 98% in~     low risk patients undergoing elective Caesarean section. It has a double aperture design~     that facilitates the introduction of an orogastric tube to aspirate gastric contents.~      The primary study hypothesis is the first attempt insertion success rate of SLMA use in~     urgent Caesarean section.~   "
78732|NCT02026869|"~     Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay~     in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as~     metformin. Oral administration of metformin is accompanied by undesirable side effects. The~     vagina proved to be a good alternative to the oral route for other drugs. Using metformin~     through the vagina and avoidance of such side effects, while maintaining its effectiveness,~     would help women to better tolerate this drug.~   "
78733|NCT02026856|"~     This study looked at parenteral administration of selenium to septic patients and~     subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the~     development of clinical status.~   "
78741|NCT02026752|"~     The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1)~     infected individuals that have viral loads across the dynamic range of the Aptima HIV-1~     assay. The plasma samples will be tested in a method comparison study to support the~     approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of~     the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by~     comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc.,~     Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of~     the Aptima HIV-1 assay.~   "
78742|NCT02026739|"~     The study hypothesized that a relative low oxygen concentration (40%) supplemental would be~     advantageous to protect the pulmonary function of patients, comparied with conventional high~     oxygen concentration (80%). Therefore we raise this prospective randomized controlled~     research.~   "
78743|NCT02026726|"~     The purpose of this observational study is to show whether a standard oral steroid dose pack~     can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid~     injection (ESI). If an oral steroid does not give a patient significant temporary relief of~     pain from a herniated lumbar disc then an epidural steroid injection will not either.~     Therefore the risk and expense associated from the interventional pain management procedure~     for those patients could be avoided and other treatment modalities pursued.~   "
78744|NCT02026713|"~     All consecutive patients undergone PTCA in the period between July 2013 and December 2013~     are eligible to be enrolled. Study population are divided in :~      Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10~     mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and~     Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with~     ASA(100 mg once a day) and Clopidogrel (75 mg once a day).~      Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics~     Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system~     that measures platelet-induced aggregation. These value are measured Platelet function,~     measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (>1~     month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at~     the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are~     expressed in P2Y12 reaction units (PRU). PRU values >240 are suggestive of high platelet~     reactivity.~      Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting~     smoking.~   "
78745|NCT02026700|"~     We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in~     protecting hands of individuals with hand dermatitis, either due to allergy or irritation.~     We believe that the use of the cream would benefit with the skin.~   "
78746|NCT02026687|"~     The purpose of the study is to compare epidural analgesia and intrathecal analgesia for~     explorative laparotomy through a middle-line incision for gynecological cancer in a fast~     track program to se if there is any difference in recovery. Length of stay is analyzed~     together with self-rate quality of life.~   "
78747|NCT02026674|"~     The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.~      The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based~     uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at~     the desired moment. Moreover, a single measurement of the voided parameters is a poor~     representative of the patient condition due to high variability of the measured parameters.~     Performing multiple Urofowmetry measurements provides representative and more accurate~     results, in a more patient-friendly, cost effective method.~   "
78748|NCT02026661|"~     To determine the association of factors affecting the clinical pregnancy and live birth~     rates in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic~     sperm injection (ICSI) and/or laser assisted hatching (LAH) or neither.~      After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF~     between January 2007 and December 2010 were included in the analysis. Patients were divided~     into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only,~     3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate~     and multivariate analyses were performed.~   "
78749|NCT02026648|"~     Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed~     countries over the past 40 years, however, there has also been an increase in relative and~     absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix~     over the same period.~      Our understanding of the natural history and optimal management of AC is limited. It appears~     that AC and SCC of the cervix behave differently. They are different in epidemiology,~     prognostic factors, and patterns of failure after similar treatments. Available data suggest~     that they may also differ in their response to treatment. We postulate that new treatment~     strategies specifically tailored to AC should be explored.~      However, there is few data about outcome of cervical cancer in Taiwan. So we propose this~     proposal for retrospective analysis of clinicopathological parameters and outcomes in~     patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous~     carcinoma.~   "
78750|NCT02026635|"~     A research study to determine if heart failure can be medically managed using data collected~     from cardiac monitoring devices~   "
78751|NCT02026622|"~     The main objective is to compare the physiological reactivity (heart and respiratory rates,~     galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion~     between depressive subjects, subjects remitted from depression and control subjects.~   "
78752|NCT02026609|"~     Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients~     with cirrhosis and refractory ascites. However, mental changes known as hepatic~     encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE~     after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess~     the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also~     predispose patients to HE. The aim of the present study is to assess if both the OGC and~     psychometric tests can accurately predict the development of overt HE after TIPS. Patients~     will be studied before TIPS and followed after TIPS for the development of HE. The role of~     muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be~     investigated.~   "
78765|NCT02026440|"~     The VioOne Oral Fluid Sample Collection Device can be used to collect human oral fluid~     samples for detection of cotinine using an ELISA cotinine assay.~   "
78753|NCT02026596|"~     Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about~     1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a~     mortality rate of 12 % acutely and 40 % of patients die within a month from admission to~     hospital. In addition, 30 % of the surviving patients remain with neurological deficits.~     Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks~     from the insult.~      Despite the advances in neurosurgical and -radiological techniques and intensive care, the~     mortality and morbidity rates in SAH have not changed in recent years. There is still only~     limited understanding of the mechanisms of secondary insults causing brain injury after SAH.~      In this study the investigators are aiming to clarify the timescale and mechanisms~     contributing to the secondary insults. The investigators also explore usability of novel~     biomarkers to guide treatment of the patients suffering from SAH.~   "
78754|NCT02026583|"~     1. Study Objectives 1) Primary Objective: Progression-free survival 2) Secondary~          Objectives:~             1. overall survival~             2. response rate~             3. incidence, nature and severity of all adverse events~             4. lipid lowering effect of simvastatin~             5. exploratory biomarker analysis : angiopoietin 2, BiP (Binding protein), Hsp (Heat~               shck protein) 90α~        2. Study hypothesis In our recent in vitro study, addition of simvastatin to bevacizumab~          reduced proliferation, migration, invasion and tumor formation of endothelial cell.~          Moreover, colorectal cancer cell media which was treated with simvastatin combined with~          bevacizumab inhibited endothelial cell invasion and it was associated with decreased~          mediator of angiogenesis, such as angiopoietin 2, BiP and HSP 90α.. Treatment with~          bevacizumab and simvastatin more reduced the growth of xenograft tumors compared with~          bevacizumab alone.~        3. Assessments 1) Safety : physical examination, vital signs, body weight, ECOG (Eastern~          Cooperative Oncology Group) performance status, clinical laboratory evaluation~          (chemistry, blood cell count) and any AE (adverse effect) graded by using CTCAE (Common~          Toxicity Criteria for Adverse Effects ) v 4.0 2) Efficacy : progression-free survival~          and overall survival will be collected. Response rate according to RECIST (Response~          Evaluation Criteria in Solid Tumors) 1,1 guideline will also be evaluated 3) PFS~          (Progression free survival): time from randomization to tumor progression or death 4)~          OS (Overall survival) : time from randomization to death or last follow-up 5) Biomarker~          analysis; The correlation between blood level, protein expression of angiopoietin 2,~          BiP, Hsp90α and clinical response will be explored.~   "
78755|NCT02026570|"~     Objectives: The purpose of this study is to investigate attentional (internal vs. external)~     focus effects on persons with amputation to perform a defined compensatory movement to~     reduce the likelihood of a fall. An internal focus of attention directs a person's conscious~     attention to their body's movements, whereas an external focus of attention directs a~     person's conscious attention to the effects of their movements or specific features in the~     environment. Numerous experiments have investigated the effects of an internal and external~     focus of attention on motor performance and the findings are in favor of an external focus~     of attention. In our work, we propose a motor learning research experiment to evaluate~     attentional focus strategies on the rehabilitation outcomes of learning and adaptation to~     the new proprioceptive information for persons with a recent transtibial amputation.~      Research Design and Methodology: For this pilot study, six participants with recent~     unilateral transtibial amputation will be recruited. Four participants will receive internal~     and external focus of attention training methods while the other two (control group) will~     receive standard prosthetic training instructions. The experiment will be conducted in three~     phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 -~     Learning Test. The training will utilize a vibrotactile device designed to generate tactile~     sensations at the skin-socket interface simulating contact of the prosthesis with the~     environment. The sensation simulates a perturbation that signals a potential fall event.~     During the experiment the augmented sensory information will be introduced randomly while~     participants walk at a preferred pace on a level surface. Movement kinematics and kinetics~     of the body will be recorded for analyses using a motion capture system with force plates.~      Finding: It is hypothesized that the external focus of attention condition will outperform~     the internal focus of attention condition when responding to perturbations. The external~     focus of attention condition will yield faster response time and show improved compensatory~     responses compared to the internal focus of attention group by producing a greater lateral~     displacement of the artificial limb relative to the line of progression. In addition, the~     external condition will demonstrate a greater step length and step height than the internal~     focus of attention condition when provided with a perturbation.~      Clinical Significance: Current practices within the field of Physical Therapy reveal that~     there is little therapeutic intervention for fall prevention. Instructions are traditionally~     provided on how to reduce the risk of falling through preparation of a room or obstacle~     avoidance or on the proper way to fall to decrease injury. However, there are no protocols~     for providing a prosthetic user with compensatory strategies to avoid a fall after a~     perturbation occurs. The research findings can result in improved training protocols, which~     can improve rehabilitative outcome.~      Impact/Significance: The growing number of prosthetic users presents a need for improved~     patient care and effective prosthetic training and rehabilitation methods. Complimentary to~     the mission of the VA, the results of this research could enhance the quality of patient~     care and further assist these patients toward becoming prosthetically rehabilitated.~   "
78756|NCT02026557|"~     To describe lethality among children with congenital heart disease in Norway~   "
78757|NCT02026544|"~     The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic~     Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.~   "
78758|NCT02026531|"~     The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At~     present cardiac catheterisation is the cornerstone investigation in these patients where it~     is used to establish disease severity and estimate prognosis. It is an invasive procedure~     which is expensive and not without risk to the patient. Despite the multitude of tests~     performed, identifying those patients with PH who have a poor diagnosis can be difficult.~     The aim of this study is to improve the assessment of patients with PH using novel magnetic~     resonance techniques.~   "
78759|NCT02026518|"~     Fasting blood specimens will be taken from the patients with IBS that have inclusion~     criteria. First, the objectives and method of study will be explained to the patients and~     informed consent form will be taken from them. They will be divided into 4 groups by an~     adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress~     questionnaires will be completed before and after intervention. During 6 weeks, they will~     receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the~     other placebo form, both of them and placebo of both. At the end, body mass index ( BMI),~     serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut~     permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen~     receptors will be determined.~   "
78760|NCT02026505|"~     The purpose of this study is to learn more about how a drug commonly used to treat multiple~     myeloma can affect the heart.~      In this study, the investigators will learn whether a drug called how a drug (called~     bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part~     of the standard treatment and its effects on multiple myeloma is not being studied here.~      The investigators want to learn whether damage occurs to the heart after taking bortezomib~     for multiple myeloma, whether it is reversible, and we can predict damage to the heart~     before it occurs.~   "
78761|NCT02026492|"~     The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to~     the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced~     bronchoconstriction. The sensitivity and repeatability of the exercise test will be~     measured.~   "
78762|NCT02026479|"~     The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have~     obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic~     injection is the latest findings in clinical work and a new noninvasive way of~     administration which is gradually expanding research. The aim of this experiment is to~     verify and explore the efficacy and safety of the postauricular injection treatment with~     different doses of Glucocorticoids.~   "
78763|NCT02026466|"~     This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be~     conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies~     and procedures. The overall objective is to address current gaps in knowledge regarding~     CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.~   "
78764|NCT02026453|"~     We will test two interventions to improve the accuracy of medication histories obtained at~     hospital admission. The interventions will target elderly and chronically ill patients prone~     to erroneous medication histories and resultant medication errors. For targeted patients, we~     will test the effect of using pharmacists and pharmacy technicians to obtain an initial~     medication history. This will be studied using a randomized controlled trial of usual care~     (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy~     technicians to obtain an admission medication history.~      Our overarching hypothesis is that by leveraging pharmacists and pharmacy technicians we can~     minimize admission medication history errors and related downstream events.~   "
78766|NCT02026427|"~     The participants were hospitalized in Orthopedic and Traumatology Departments in Military~     Institute of Medicine, Warsaw, Poland.~      The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and~     (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered~     during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder~     catheterization was perform during the surgery were excluded from the study.~      The participants were randomly divided into the study and control groups. No oral~     premedication was administered. All the patients were asked to empty their urinary bladders~     before arrival to the operating theatre. When the standard monitoring (continuous~     electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous~     premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric~     0.5% solution of bupivacaine hydrochloride was performed.~      In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride~     was administered intramuscularly. The decresed intravascular volume was corrected with~     cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay~     scale, level of sedationt was obtained with midazolam and/or propofol. All the participants~     received a questionaire in which we asked the questions about (1) the duration of~     anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in~     the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to~     catheterization. On the next day after the surgery the questionaires were collected. In~     cases, when the patient's dischaged from the hospital was planned during the weekend, he or~     she was asked to pass on the questionaire to the nurses.~   "
78767|NCT02026414|"~     PrimaVie (Natreon Inc), is a a purified and standardized shilajit extract for nutraceutical~     use. Research indicates that PrimaVie® has targeted action for increasing energy,~     revitalization and anti-aging. Findings on a recent murine study revealed that PrimaVie (PV)~     significantly changed the expression of genes related to muscle function (unpublished data).~     Based on these facts, it was thought of interest to study the effect of PrimaVie and~     exercise training on human skeletal muscle adaptation.~      The objective of the study is to determine effect of PrimaVie supplementation and combined~     PrimaVie supplementation and exercise on changes in muscle gene expression related to muscle~     function. Two hypothesizes have been made, oral supplementation of PrimaVie twice a day for~     12 weeks will influence gene expression in the skeletal muscle of pre-obese to obese humans,~     oral supplementation of PV will act with treadmill exercise training to favorably impact~     skeletal muscle gene expression. The participants will have a total of 3 visits over 12~     weeks. During each visit will include measurement of height, weight and vital signs, 2~     tablespoons of blood will be draw from left or right arm, and muscle biopsies (using biopsy~     needle) will be collected under the use of local anesthetics. The blood and muscle biopsies~     will be used for all lab related procedure.~   "
78768|NCT02026401|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282~     in patients with Primary Biliary Cirrhosis.~   "
78769|NCT02026388|"~     This study is being done to obtain samples from patients with primary hyperoxaluria,~     cystinuria, adenine phosphoribosyl transferase (APRT) deficiency, and Dent disease, and from~     their family members, for use in future research.~   "
78770|NCT02026362|"~     To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group'~     in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in~     China.~   "
78771|NCT02026349|"~     The purpose of this study is to determine if favipiravir is effective in reducing the time~     to resolution of influenza symptoms.~   "
78772|NCT02026336|"~     Patients with persistent asthma have different inflammatory phenotypes. The electronic nose~     is a new technology capable of distinguishing volatile organic compound breath-prints in~     exhaled breath among different pulmonary diseases.~      Question of the study. Is the electronic nose breath-print analysis able to discriminate~     among different inflammatory asthma phenotypes?~   "
78773|NCT02026323|"~     Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic~     ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term~     risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical~     stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve~     insulin sensitivity. Whether these findings can be translated into women with PCOS has not~     been investigated. Therefore, this study aims to evaluate whether acupuncture improves~     insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis~     is that acupuncture with combined manual and low-frequency electrical stimulation of the~     needles improves insulin resistance, induces ovulation and improves quality of life.~   "
78774|NCT02026310|"~     All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and~     evidence is sufficient.At the same time the basal insulin injection once a day are more and~     more widely used in diabetes patients in China.~      This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes~     patients with inadequate glycemic control with combined therapy of metformin and basal~     insulin.~   "
78795|NCT02026037|"~     The investigators propose to develop and pilot-test a short-term cognitive-behavioral~     treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic~     symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This~     is important because approximately one third of burn survivors develop PTSD after discharge.~     PTSD is associated with extended psychological suffering and a greater need for medical~     services in the future. Although there are treatments for chronic PTSD, there are far fewer~     interventions available to treat acute posttraumatic symptoms before they develop into this~     disorder, and none to date has focused on adult burn survivors. The little research~     available on other forms of trauma suggests that interventions developed to treat PTSD may~     be helpful in preventing PTSD when used in the first weeks following a trauma.~      The investigators will develop a six-session intervention package for use with patients at~     the Los Angeles County + University of Southern California Burn Center. The intervention~     will translate CBT principles that have been validated with trauma survivors, but will be~     adapted to hospitalized burn patients. After manual development, we will pilot-test this~     treatment on 15 patients who are medically stable, and not critically ill, intubated, or~     delirious. Treatment will consist of three 50-minute CBT sessions per week, involving~     mindfulness-focused relaxation training, graduated exposure to memories of the burn,~     psychoeducation, and cognitive restructuring. Assessment will include standardized tests of~     posttraumatic stress, anxiety, and depression, administered at the initiation and~     termination of treatment, and at one-month follow-up. Also assessed will be number of~     hospital days to discharge and participant satisfaction with treatment. We will evaluate the~     overall feasibility of conducting a study on PTSD prevention in burn survivors, as measured~     by initial recruitment success, subsequent dropout rates at the end of treatment and at the~     one-month follow-up, and participant satisfaction. These data will then be used to support a~     subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.~   "
78775|NCT02026297|"~     The aim of this study is to characterize the coagulation changes, using thromboelastography~     (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically,~     TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo~     before surgery, during elective cesarean delivery, and 2 hours postpartum.~      Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing~     interest in multimodal approaches to blood conservation during cesarean delivery.~     Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown~     to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global~     coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not~     been elucidated.~      This study will be conducted as a randomized, double-blind, controlled trial with two study~     arms: control (60 patients); and treatment (60 patients).~      Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral~     sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and~     noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen,~     serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT),~     prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum~     amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured~     throughout surgery as per standard of care. Patients will all receive IV lactated Ringers'~     (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of~     less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal~     anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and~     hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general~     anesthesia conversion, general anesthesia planned), indications and medication doses used~     will be noted for analysis.~      Immediately following induction of anesthesia and prior to skin incision, infusion of study~     solution will be initiated.~      Study solutions will consist of:~        1. Control group: 100 mL 0.9% normal saline (NS).~        2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will~          be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual~          estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured~          throughout the study. All routine care lab values will be noted. At minimum, one lab~          panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen,~          platelet count, aPTT, PT, and TEG).~   "
78776|NCT02026284|"~     The investigators aim to evaluate the preferences for anaesthesia methods of gravid women~     who are to deliver baby by caesarean section, the rates of general anaesthesia and regional~     anaesthesia, the reasons for preferences of general anaesthesia and regional anaesthesia and~     the factors affecting these preferences.~      A questionnaire consisting of 20 questions were applied to gravid women applying for~     delivery by elective caesarean operation, at Ankara University Faculty of Medicine Hospital~     for Gynaecology and Obstetrics between February 2010 and February 2011, in order to study~     the anaesthesia technique the patients prefer and the reason behind their preferences. Those~     gravid women who accepted to take part in the study were provided information about the~     questionnaire and their oral and written approvals were obtained.~   "
78777|NCT02026271|"~     This research study involves two investigational drugs, veledimex, an activator ligand~     (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12~     (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by~     enhancing the ability of the immune system to kill tumor cells and may interfere with blood~     flow to the tumor.~      The main purpose of this study is to evaluate the safety and tolerability of a single tumor~     injection of INXN-2001 given in combination with oral veledimex.~   "
78778|NCT02026258|"~     The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure~     will have a transient acceleratory effect on the rate of tooth alignment and the overall~     treatment time. In addition, the subjects in the piezotome-corticision orthodontics group~     will experience a different level of pain, comfort, and satisfaction as opposed to the~     conventional orthodontics group.~   "
78779|NCT02026245|"~     In this study we will compare two electronic goniometric gloves to see if they can be used~     in research on joint movement in arthritis.~      One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other~     is a glove that we have specially designed and developed for use in people with arthritis.~     Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.~      We aim to find out if the gloves are accurate and if they can be worn and used without too~     much discomfort by people with arthritis.~   "
78780|NCT02026232|"~     The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes~     to hydroxychloroquine, 200 mg twice daily or placebo.~   "
78781|NCT02026219|"~     Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than~     clopidogrel and is associated with less interindividual variability. In the PLATO trial, it~     was found to be superior to clopidogrel with respect to cardiovascular outcomes and total~     mortality without increasing the risk of bleedings.~      More potent and reversible receptor bindings are possible explanation for the superior~     outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has~     previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake~     in tissue level and can induce adenosine triphosphate (ATP) release from human red cells,~     which both stimulate vasodilation of in red blood cells.~   "
78782|NCT02026206|"~     The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach~     of skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).~   "
78783|NCT02026193|"~     The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because~     of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the~     investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the~     introduction of oocyte vitrification (very fast cooling) technology, a new option emerged:~     to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.~      The purpose of this study is to compare the outcome of these two approaches.~   "
78796|NCT02026024|"~     Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1~     (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by~     boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly~     controlled Type 2 diabetes patients. This study is designed to understand the~     pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.~   "
78797|NCT02026011|"~     This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene~     on biobehavioral and neural markers of response to naltrexone in individuals of East Asian~     descent, an ethnic group most likely to express the positive predictive allele.~   "
78798|NCT02025998|"~     The objective of this proposal is to advance medication development for alcoholism by~     conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and~     phosphodiesterase inhibitor, for alcohol use disorders.~   "
78799|NCT02025985|"~     The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients~     with advanced or metastatic gynaecological cancers by disease control rate (complete~     response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks,~     assessed according to RECIST 1.1 criteria).~   "
78784|NCT02026180|"~     Vascular access complications can occur during or after cardiac or peripheral arterial~     catheterization. These complications increase patient morbidity and mortality, as well as~     healthcare costs. Several strategies and devices have been employed to decrease the risk for~     vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access~     and vascular closure devices. Randomized trial data has failed to demonstrate that~     fluoroscopic guidance reduces common femoral artery access complications. While~     meta-analysis data has demonstrated that vascular closure devices decrease time to arterial~     hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do~     not reduce the incidence of vascular complications as compared to hemostasis achieved with~     manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and~     reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook~     Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to~     the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for~     the purpose of decreasing vascular access complications has not been examined in a~     randomized study to date.~      The present study is a 552 patient randomized controlled clinical trial that will help~     determine whether femoral arterial access obtained using the Micropuncture Kit will reduce~     the incidence of vascular access complications compared to the standard 18 gauge needle.~      The specific aim of this proposal is to compare the rate of femoral artery access~     complications using the Micropuncture Kit vs. standard femoral artery access.~      It is our hypothesis that the incidence of femoral artery access complications will be lower~     among patients in whom the Micropuncture Kit is used.~   "
78785|NCT02026167|"~     The objective of this study is to test the effectiveness of a collaborative care approach to~     improving outpatient treatment for inactivity, chronic pain and depression as a way of~     improving overall Quality of Life for patients with SCI.~   "
78786|NCT02026154|"~     The study objective is to clarify the grounds of heart exertional dyspnoea stenocardia in~     patients with well-controlled stage I or II hypertension according to European Society of~     Hypertension, without changes in epicardial coronary arteries in CT coronary angiography and~     normal resting echocardiography result, and to assess of potential early markers of heart~     hypertrophy and failure in patients with hypertension.~   "
78787|NCT02026141|"~     Dexmedetomidine has been often used for procedural sedation. It has also has been shown to~     have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is~     used for sedation in total knee replacements done under spinal anesthetic, the patients will~     have less pain up to 24 hours after the procedure.~   "
78788|NCT02026128|"~     Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide~     micrometer (one one-thousandths) scale imaging of biological tissue. This allows excellent~     assessment of the white blood and inflammatory cells seen in uveitis, an inflammation of any~     or all parts of the uvea (iris, ciliary body, choroid).~   "
78789|NCT02026115|"~     The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on:~     (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and~     misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250~     cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained~     appropriate analgesics for patient) in a sample of hospice nurses. The investigators~     hypothesize that at posttest, controlling for pretest data and compared to the usual care~     group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and~     pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a~     larger proportion who report satisfaction with pain intensity and whose nurses obtained~     appropriate analgesics for the patients' pain.~   "
78790|NCT02026102|"~     The purpose of this study is to test the acceptability and feasibility of a toolkit of~     patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.~   "
78791|NCT02026089|"~     The purpose of the study is to learn more abou how the immune system responds to the~     chickenpox vaccine in adults who had never had chickenpox as a child and were then~     vaccinated as an adult. The study aims to learn more about the strength and duration of the~     protection provided by the vaccine in adults, and to observe the immune response to an~     additional dose of chickenpox vaccine in adults who had received the vaccine at least 5~     years earlier. This is especially relevant to workers in a hospital who may be exposed to~     chickenpox.~   "
78792|NCT02026076|"~     This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the~     immediate response to traction can be determined by using a simple unloading test in~     standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses~     both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low~     back pain which does not travel below the knee. All subjects will rate their pain on a 100~     mm line both at rest and in their most painful direction of movement. A therapist will then~     unload the patients spine to determine if they feel any relief. All subjects will then~     undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50%~     body weight. Following traction, all subjects will again rate their pain on a 100 mm line.~     Subjects will be grouped by response to the initial manual unloading test and assessed for~     within and between group differences. The study hypothesis is that the manual unloading test~     is reliable, and that responders to mechanical traction can be accurately identified using a~     manual unloading test.~   "
78793|NCT02026063|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     orally administered telotristat etiprate.~   "
78794|NCT02026050|"~     the aim of this study was to investigate the analgesic efficacy of intra articular~     dexamethasone administration for arthroscopic shoulder surgery.~   "
78800|NCT02025972|"~     This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic~     umbilical cord blood therapy for children with cerebral palsy.~   "
78825|NCT02025647|"~     Innerview can address some of the challenges of integrating mental health and primary care~     by accurately and reliably collecting mental health evidence and activities directly from~     patients, and then organizing and automating that evidence and activity into reports for~     providers and care teams that support diagnosis, treatment planning and monitoring of the~     mental health issues within a practice population.~   "
78801|NCT02025959|"~     Getting better sleep in the hospital is especially important due to a variety of adverse~     health effects that can potentially worsen patient recovery.~      To address these concerns and improve sleep in US hospitals, we aim to develop the SIESTA~     (Sleep for Inpatients: Empowering Staff to Act) program as an educational intervention~     designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals~     and recognize the importance of screening for sleep disorders. The major educational goals~     of this proposal is to develop and pilot test an online educational program (SIESTA) which~     aims to train and motivate medical professionals to provide better sleep for hospitalized~     patients.~      We will utilize data from an ongoing sleep study, performed by the research team at the~     University of Chicago that looks at how adult patients are able to sleep while they are in~     the hospital, as a means of education for the participating medical staff.~   "
78802|NCT02025946|"~     In case of severe ankle arthritis, the two common surgical treatments are tibiotalar~     arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it~     remains difficult to determine which operation is the better solution for end stage ankle~     arthritis.~      The purpose of the present study is to analyze patient's outcome after each type of ankle~     surgery and to describe the decision making process.~   "
78803|NCT02025933|"~     It has previously been seen that increased fish intake improves the metabolic health of~     overweight and obese adults, and animal protein improved metabolic health of obese rats. In~     this project the investigators will investigate whether increased intake of fish or meat~     improve metabolic health in children aged 9-12 years as well when replacing processed food.~     The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic~     health in children as measured by glucose tolerance, lipid metabolism and inflammatory~     markers.~   "
78804|NCT02025920|"~     It has previously been observed that increased fish intake improves the metabolic health of~     overweight and obese adults, and animal protein improved metabolic health of obese rats. In~     this project the investigators will investigate whether increased intake of fish or meat~     improves metabolic health in overweight/obese adults aged 20-55 years when replacing~     processed food. The hypothesis is that increased intake of unprocessed fish or meat will~     improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and~     inflammatory markers.~   "
78805|NCT02025907|"~     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared~     to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have~     inadequate glycemic control on maximally or near-maximally effective doses of metformin and~     sitagliptin.~   "
78806|NCT02025894|"~     The purpose of this study is to identify risk factors for thromboembolic and /or infectious~     complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous~     Catheter (PCVC). A better understanding of the risk factors for these complications in this~     population would then allow interventional studies to be proposed to assess the benefit of~     prophylactic procedures in a sub-group of patients at most risk.~   "
78807|NCT02025881|"~     The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a~     phase II trial, and ii) a dose-finding part.~      The Phase II trial is an open label, non-randomized, multicentre trial without control~     group. A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will~     use three prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a~     pessimistic prior distribution, and (3) a non-informative prior distribution. As the patient~     outcomes in the trial will be recorded, the subsequent distribution of the outcome~     probability under experimental treatment will be computed by applying Bayes' theorem, which~     yields an estimated EFS probability with a 95% credibility interval (measure of Bayesian~     precision). Two interim analyses are planned to monitor the efficacy data (early stopping~     rules for futility or inefficacy).~      The final analysis of efficacy will be made on an intention to treat basis, including all~     recruited patients, 3 years after recruitment of the last patient.~      Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with~     Busilvex for the last chemotherapy course in patients in complete response after~     intensification chemotherapy treatment, a dose-finding subtrial will be performed to address~     this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using~     the Continual Reassessment Method in a Bayesian framework.~   "
78808|NCT02025868|"~     Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire,~     Mali and Senegal, West Africa.~      HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be~     recruited and followed in two phases:~        -  First, a 12-week intentive adherence reinforcement phase, during which patients will~          continue 2nd-line ART, be seen repeatidly for counseling and educational training on~          adherence, and be offered the possibility of phone, SMS and home visit contacts with~          social workers;~        -  Second, a 48-week phase, during which:~             -  Patients successfully resuppressed at the end of the first phase will continue~               2nd-line ART and adherence reinforcement;~             -  Patients with persitent virologic failure will switch to a darunavir/r +~               raltegravir-based 3rd-line ART.~      Genotype resistance tests will be performed retrospectively on frozen samples. The main~     outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64~     weeks.~   "
78824|NCT02025660|"~     Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is~     likely to increase survival in patients with severe sepsis.~      Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving~     survival and the recovery of organ function in patients with severe sepsis. This will be~     assessed with the help of the following~        -  Mortality in the two arms~        -  Daily SOFA scores~        -  Ventilator free days~        -  Time-to-vasopressor withdrawal~        -  ICU length of stay~        -  Hospital length of stay METHODS This will be a proof of the concept study to assess the~          effect of Mycobacterium w in combination with standard therapy versus standard therapy~          alone on the inflammatory profile in sepsis due to gram negative infection. A total of~          25 patients will be enrolled in each group. The patients will be randomized in balance~          to receive either test drug or its placebo along with the standard of care~   "
78862|NCT02025166|"~     To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following~     surgical abortion.~      The medication will be given at the time of the procedure. Following the abortion, pain~     level will be evaluated.~   "
78809|NCT02025855|"~     The purpose of this study is to determine if administering methadone to mechanically~     ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions~     of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated~     within 48 hours of their admission. Patients meeting enrollment criteria will be randomly~     assigned to receive methadone or placebo in addition to standard care. Methadone is a long~     acting pain medication that is approved by the Food and Drug Administration (FDA) to manage~     withdrawal from opioids and moderate to severe pain. Both of these indications are a~     frequent concern for critically ill patients that require mechanical ventilation. These~     patients often require intravenous (IV) opioids to manage the pain they experience due to~     their illness, procedures, and mechanical ventilation. During this time patients can develop~     physical dependence, which leads to withdrawal symptoms when the opioids are stopped or the~     dose is reduced. These symptoms can include agitation, pain, diarrhea and several others.~     Currently this is managed by a slow reduction in the dose of the IV opioid, but this can~     lead to prolonged time on mechanical ventilation, which has been associated with increased~     morbidity. Administering oral methadone to patients experiencing withdrawal symptoms has~     been shown to reduce and even eliminate these symptoms in the outpatient setting. This~     should also benefit patients in the ICU experiencing withdrawal from intravenous opioids~     required during their stay. It may allow for the other opioids to be discontinued more~     quickly, allowing for a shorter duration of mechanical ventilation.~      The level of pain and sedation will be assessed between groups randomized to either~     methadone or placebo in addition to current intravenous sedative and analgesic agents. The~     duration of mechanical ventilation will be assessed between both groups. Opioid withdrawal~     symptoms may manifest or be mistaken for delirium symptoms. ICU delirium is often managed~     with antipsychotic medications. To assess if methadone can reduce the need for antipsychotic~     medication, all administered antipsychotic doses will be recorded and total consumption will~     be compared between the two groups. Methadone has been associated with abnormal heart~     rhythms in rare instances. To ensure patient safety, data from the heart monitor will be~     collected and compared between the two groups to assess for QT interval prolongation.~   "
78810|NCT02025842|"~     To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological~     response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on~     Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB~     patients treated with long-term NUC therapy.~   "
78811|NCT02025829|"~     The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs)~     are central to the disease pathology in CF. This will be determined by demonstrating that~     IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease~     in patients being treated with IV antibiotics for a pulmonary exacerbation.~   "
78812|NCT02025816|"~     Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative~     agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring~     these devastating infections~      Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will~     be used for standard clinical analysis of bacterial species present or stored for later RNA~     sequencing. RNA sequencing will identify bacteria that are present within the infection site~     that may not be detected using standard culture techniques as well as reveal bacterial gene~     expression profiles within the NSTI site. Medical charts will also be reviewed for basic~     patient information as well as wound care management practices. We hope to identify~     bacterial species commonly present in these types of infections as well as risk factors~     predisposing individuals to NSTI's.~   "
78813|NCT02025803|"~     The purpose of this exploratory study is to investigate the safety and determine the maximum~     tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced~     solid tumors for which the patients have no available therapy likely to convey clinical~     benefit.~   "
78814|NCT02025790|"~     The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment~     of achalasia cardia.~   "
78815|NCT02025777|"~     Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of~     the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and~     clinical impact of IBD capsule in detecting lesions associated with UC Disease and to~     determine the agreement between PillCam Platform with the IBD capsule and optical~     colonoscopy in the evaluation of UC disease extent.~      Primary Scientific Objective To evaluate the agreement between PillCam IBD system and~     optical colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis,~     Left-sided colitis, Pancolitis)~      Proposed Design Established UC disease patients whose clinical condition suggests ongoing~     disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or~     other obstruction that would prevent capsule passage will be enrolled in this study.~      Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and~     colonoscopy examination.~      The Rapid videos will be evaluated by two readers, each from a different site, the~     colonoscopy videos will be evaluated by two other physicians, at the sites~      INCLUSION CRITERIA~      All subjects must fulfill all of the following inclusion criteria:~        -  Patients ages 18 years and up~        -  Patient has known UC according to physician discretion~        -  Patient has at least one positive inflammatory marker from the following:~             -  ESR~             -  CRP~             -  CBC~        -  Patient is indicated and eligible for a standard of care colonoscopy examination~        -  Patient agrees to sign consent form~      EXCLUSION CRITERIA~      The presence of any of the following will exclude a patient from study enrollment:~        -  Crohn's Disease~        -  Antibiotic Associated Colitis~        -  Stool positive for O&P (C&S within 3 months of enrollment)~        -  Other known infectious cause of increased symptoms~        -  Known intestinal obstruction or current obstructive symptoms, such as severe abdominal~          pain with accompanying nausea or vomiting.~        -  Definite long stricture seen on radiological exam.~        -  Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during~          the 4 weeks preceding enrollment~        -  Suspected GI stricture, followed by patency capsule study or other imaging study that~          could not prove patency of the GI tract.~        -  Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6~          months, other than uncomplicated procedures that would be unlikely to lead to bowel~          obstruction based on the clinical judgment of the investigator.~        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the~          capsule.~        -  Patient with known gastrointestinal motility disorders.~        -  Subjects with known or suspected delayed gastric emptying~        -  Patient suffers from any condition, such as swallowing problems, which precludes~          compliance with study and/or device instructions.~        -  Patient has Type 1 or Type II Diabetes.~        -  Patient has any allergy or other known contraindication to the medications used in the~          study.~        -  Patient has any condition, which precludes compliance with study and/or device~          instructions.~        -  Women who are either pregnant or nursing at the time of screening, or are of~          child-bearing potential and do not practice medically acceptable methods of~          contraception.~        -  Concurrent participation in another clinical trial using any investigational drug or~          device.~        -  Patient suffers from a life threatening condition~        -  Patients with history or clinical evidence of renal disease and/or previous clinically~          significant laboratory abnormalities of renal function parameters.~   "
78816|NCT02025764|"~     The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of~     visible vessel because of injection material.~      The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer~     base over time after prophylactic APC in colonic EMR.~   "
78817|NCT02025751|"~     The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray~     compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.~   "
78818|NCT02025738|"~     Data on the perioperative management of patients cardiac implantable electronic devices~     (CIEDs) is limited and published guidelines rely mainly on the experience of the~     cardiologists and anesthesiologists who manage these patients. Depending on the device type~     and patient's dependency, these guidelines recommend the intraoperative magnet use,~     reprogramming of devices or no action. Magnet placement on a CIED (very simple and~     applicable method) has become the standard approach in many centers, while CIED reprograming~     by trained personnel is required in most centers. Therefore, our objective is to compare in~     a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS~     reprogramming vs. no intervention (in the appropriate subjects)~   "
78819|NCT02025725|"~     The purpose of this study is provide confirmation of the safety and efficacy of~     Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic~     gastroparesis in adult women.~   "
78820|NCT02025712|"~     The purpose of this study is to determine whether exemestane plus everolimus are effective~     in the treatment of patients who have achieved disease stabilization after induction~     chemotherapy for hormone-receptor positive metastatic breast cancer.~   "
78821|NCT02025699|"~     The TAILORED-Treatment consortium was established to develop new tools aimed to increase the~     effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit~     the emergence of antimicrobial resistance in children and adults.~   "
78822|NCT02025686|"~     The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect~     in humans induced by tonic heat stimulation. It has been shown in animal studies with rats~     that HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The~     authors are not aware of similar studies in human subjects investigating this effect of HBO.~     Aim: To investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced~     by heat stimulation in healthy subjects and promote future research and understanding of the~     anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary~     hyperalgesia after HBO.~   "
78823|NCT02025673|"~     Betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation,~     improves glucose tolerance and regulates lipids metabolism. A recent study showed that~     circulating concentrations of betatrophin doubled in type 1 diabetes. The objective of this~     study is to investigate the association of serum betatrophin levels with the progression of~     diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in~     gestational diabetes patients and pregnant women.~   "
80264|NCT02006836|"~     Food intake has a great influence on blood glucose of patients with diabetes. This study was~     designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and~     its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients~     with type 2 diabetes (T2DM).~   "
78826|NCT02025634|"~     The purpose of this randomized, placebo controlled, single blind study is to determine if~     postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are~     reduced with the administration of IV acetaminophen when compared to a control group.~     Particular focus will be on the postoperative opioid consumption. In addition, we will~     ascertain if the total time the participant is in the PACU differs in those who receive the~     IV acetaminophen versus those who do not.~   "
78827|NCT02025621|"~     A study to evaluate levosimendan compared with placebo in reducing the composite event rate~     of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist~     (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery~     on cardiopulmonary bypass (CPB).~   "
78828|NCT02025608|"~     The purpose of this study is to explore whether patients with restless legs syndrome (RLS)~     differ from healthy subjects in daytime and night time autonomic function and cardiovascular~     risk markers and whether 4 week treatment with pramipexole affects autonomic function and~     cardiovascular risk markers in patients with RLS.~   "
78829|NCT02025595|"~     The aim of this study is to investigate the effects of genetic and environmental risk~     factors on central nervous system (CNS) reward and satiety circuits in the etiology of~     obesity. The investigators will also investigate to what extent the alterations in CNS~     reward and satiety circuits are a cause or a consequence of the development of obesity.~   "
78830|NCT02025582|"~     Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently,~     is approached in vastly varying ways of intervention, including serial casting, Botox~     injections and physical therapy. There is some evidence in the literature that children with~     ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily.~     Kinesio Taping (KT) method is an intervention that is used in the outpatient physical~     therapy setting for various conditions such as post-operative edema, muscle facilitation of~     weakened rotator cuff muscles, and functional corrections in children with torticollis. This~     pilot study will strive to determine if KT may be effective by providing proprioceptive and~     neuromuscular re-education through thermal and mechanical fascial impositions, thereby~     improving passive joint range of motion (ROM) through reduction of passive muscle stiffness~     and improving ambulation through neuromuscular re-education in children with idiopathic toe~     walking. We will quantify passive muscle stiffness of the gastrocnemius and opposing~     anterior tibialis using non-invasive Shear Wave Elastography (SWE). Further we look at the~     kinematics and kinetics of the child's ankle during the gait cycle to further determine any~     effect(s) of KT on functional walking outcome measures. The intent is that the results from~     this study will serve as a platform from which to expound look at the long-term, if any,~     effects of KT on the muscle property and gait cycle pattern in children with ITW.~   "
78831|NCT02025569|"~     This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of~     chronic ankle instability.~   "
78832|NCT02025556|"~     The purpose of this study is to determine whether monthly subcutaneous administration of~     LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic~     migraine.~   "
78833|NCT02025543|"~     The purpose of this multi-site research is to validate a rapid magnetic resonance based~     confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron~     concentrations.~   "
78834|NCT02025530|"~     The United Kingdom has one of the highest rates of stillbirth in Europe, with more than~     4,000 stillbirths every year; which equates to more than 11 deaths every day. Furthermore,~     this rate has changed very little over the last 20 years. This loss of life and the adverse~     psychological consequences urgently needs addressing.~      A recent New Zealand study investigating modifiable factors associated with stillbirth (the~     Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had~     a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to~     sleep on their left side. These novel findings need urgent confirmation.~      This proposed study aims to confirm or refute these findings and to ascertain whether a~     preventative programme should be introduced. This proposed study aims to confirm or refute~     the findings of the Auckland Stillbirth Study.~      Participants will be recruited from maternity units in the Midlands and North of England~     (led by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a~     singleton late stillbirth without congenital abnormality will be interviewed by research~     midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will~     be interviewed at a gestation group matched to that at which stillbirths occurred. These~     data will determine whether an intervention study should be considered. If there is a causal~     relationship between maternal sleep position and late stillbirth we estimate that upto 37%~     of late stillbirths might be prevented.~   "
78835|NCT02025517|"~     Treadmill gait training combined with cognitive tasks in Parkinson's disease.~   "
78836|NCT02025504|"~     Colonoscopy is the gold-standard for colorectal cancer screening in the US. However,~     complete colonoscopy can be a challenging technical procedure, even for expert~     gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of~     the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp~     detection, and impact patient experience and tolerance. The investigators propose to~     evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the~     performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial.~     Eligible participants undergoing colonoscopy at University of North Carolina Hospitals~     (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or~     sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome~     will be time to distal extent (cecal intubation time). Secondary outcomes include~     colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural~     difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be~     assessed on the basis of pairwise comparisons between groups with respect to primary and~     secondary outcomes.~   "
78863|NCT02025153|"~     To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical~     pain) in women who will develop CPSP compared to women with no CPSP after hysterectomy. This~     mechanism is illustrated by a higher pain score in experimental pain models such as tonic~     heat stimulation, increased evoked mechanical temporal summation and increased wound~     hyperalgesia.~   "
78837|NCT02025491|"~     Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with~     increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular~     and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of~     lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40%~     of the cases.~      DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been~     documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte~     de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of~     high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to~     relevant drug toxicity, high morbidity due to a long lasting disease, with an important~     socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure~     rate than historic cure rates of pentavalent antimony in the treatment of disseminated~     leishmaniasis.~   "
78838|NCT02025478|"~     The investigators hypothesize that children receiving human milk will maintain a greater~     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in~     the blood compared with children not receiving human milk.~   "
78839|NCT02025465|"~     Atrial Fibrillation and atrial flutter (AF/FL) is the usually irregular beating of the heart~     and is a rapidly growing cause of hospitalization. Between 1993 to 2007 AF/FL~     hospitalizations have increased 203% compared to a 71% increase for all hospitalizations.~     Changing procedure management such as ablation, transesophageal have had a minimal impact on~     the trends and there is a need to evaluate Emergency Department (ED) management options of~     AF/FL that may decrease hospitalizations.~      The most commonly used medications to control heart rate are metoprolol (MET), a beta~     blocker, or diltiazem (DT), a calcium channel blocker. Beta blockers are medications that~     cause the heart to beat more slowly and with less force. DT also helps blood vessels open up~     to improve blood flow. Both DT and MET are used alone or together with other medicines to~     treat severe chest pain (angina), high blood pressure (hypertension) or rapid heartbeat.~     Both are equally acceptable according to recent guidelines for AF/FL. There are limited~     studies comparing MET to DT for rate control for AF/FL.~      The initial goal for AF/FL management in the Emergency Department is usually rate control.~      The most commonly used rate control medications are metoprolol (MET), a beta blocker, or~     diltiazem (DT) a calcium blocker. Three major guidelines, including the American College of~     Cardiology (ACC) and the American Heart Association (AHA) indicate beta blockers and DT are~     equally acceptable medications for rate control in AF (3,4,5) assuming no contraindications.~      There are limited studies comparing beta blockers (BB) to DT for rate control for AF:~        1. Demircan, et. al., compared bolus intravenous BB and DT in 40 patients over a 20 minute~          period. No follow-up information after 20 minutes was reported. No attempt was made to~          look at intermediate or long term results. No patients converted to normal sinus rhythm~          over this short treatment period and there was slightly more rate decrease at 20~          minutes, with DT versus BB (6).~        2. Time from medication administration to heart rate and rhythm control. Additionally,~          currently guidelines consider BB or DT medications to slow AF/FL; however, there are~          some suggestions that BB may not only slow heart rate in AF/FL (as does DT) but also~          increase all AF/FL conversion from AF/FL to normal sinus rhythm(2), and aid in~          maintaining normal sinus rhythm (NSR) after cardioversion (10). With recent onset AF/FL~          occurring within 48 hours prior to the arrival to the ED, approximately 50% of AF/FL~          patients convert to normal rhythm spontaneously within 24 hours after arrival to the ED~          (6), making evaluation of current limited studies difficult. Thus, the investigators~          wish to examine the effect of initial medication strategy on time to NSR in a larger~          sample than has been previously performed.~        3. A randomized study of 48 patients in China reported significantly slower heart rate up~          to 20 minutes with DT 10mg IV versus metoprolol 5mg IV but not after 30 minutes (7).~        4. A retrospective study of post-operative coronary bypass patients showed the intravenous~          administration of the BB, esmolol, to be more effective than DT for rate control and~          conversion of AF/FL (8).~        5. Hassan et al reported no difference in conversion to regular rhythm with esmolol verses~          DT in a small, under powered, randomized study of fifty ED patients (9). Conversion to~          sinus rhythm occurred in 10 patients (42%) in the DT group compared with 10 patients~          (39%) in the esmolol group (P = 1.0). There were no statistically significant~          differences in heart rate between the two medications at 1, 6, 12, and 24 hours after~          initiation of esmolol or DT infusion.~      Examples of such well quoted strategy trials are the COURAGE trial published in the New~     England Journal of Medicine and the PROMISE Trial, a worldwide multi-centered study that is~     nearing completion goal of 10,000 patients of which, Charleston Area Medical Center (CAMC)~     has enrolled approximately 100 patients. In this trial, patients being evaluated for chest~     pain will be randomized to two treatment strategies and subsequent outcomes will be~     recorded.~      Strategy trials do not attempt to manage treatment after an initial management strategy has~     been determined by randomization, but, whether the initial treatment affects long-term~     outcomes.~      This will be a prospective, randomized study comparing the outcomes of a strategy using~     either MET or DT in patients with AF presenting to the Charleston Area Medical Center (CAMC)~     ED. After presentation and receiving consent, the patient will be randomized to receive~     either MET or DT.~   "
78840|NCT02025452|"~     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have~     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a~     treatable cause for their illness. We will conduct a randomized trial to see if rapid~     testing using novel methods to identify potentially treatable causes of diarrhoea leads to~     improved outcomes. We will also be randomizing children to probiotic therapy versus placebo~     (the standard of care) to see if this treatment decreases the duration of diarrhoea. The~     proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.~   "
78841|NCT02025439|"~     The purpose of this study is to examine the safety and efficacy of repetitive transcranial~     magnetic stimulation (rTMS) combined with Amantadine relative to rTMS Alone and Amantadine~     Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is~     that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or~     accelerates functional recovery.~   "
78842|NCT02025426|"~     Phenylephrine administration is associated with reductions in CO and SctO2 compared with~     ephedrine when used for blood pressure management in women with pre-eclampsia undergoing~     cesarean delivery under spinal anesthesia.~   "
78843|NCT02025413|"~     The primary objective of the preliminary lead-in study is to determine whether circulating~     tumor cells in patients with metastatic progressive castration-resistant prostate cancer or~     metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based~     ferrofluid (N-cadherin or O-cadherin based).~      The primary objective of each comparative cohort (second stage, prostate cancer) is to~     compare the non-detection rate of circulating tumor cells between the standard and novel~     methods.~   "
78844|NCT02025400|"~     The investigators have previously reported on patient utilization of an eRehab patient~     education web portal that utilizes streaming, clinician prescribed video instruction to~     motivate and inform patients in self-care of their orthopedic condition, focusing on the~     importance of a home exercise program. The greatest barrier to patient use of this web-based~     home exercise treatment plan was the initial access to the program. The purpose of this~     study is to compare an Internet-based patient education rehab portal (eRehab) to formal~     physical therapy (PT) in terms of patient costs and outcomes.~   "
78845|NCT02025387|"~     Examine whether the measurement and feedback of physical activity increase the physical~     activity in women who underwent midline incision, gynecological surgery~   "
78846|NCT02025374|"~     Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with~     hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for~     analgesics in patients undergoing elective cesarean section. Our hypothesis is that~     hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic~     conditions compared to hyperbaric bupivacaine.~   "
78847|NCT02025361|"~     Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for~     prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective~     biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient~     tolerance may improve the protocol effectiveness and quality.~      Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate~     in TRUS-Bx.~   "
78848|NCT02025348|"~     This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.~      The study will characterise the performance of IntelliCap® by evaluating the plasma~     concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from~     IntelliCap® with three different release profiles and the plasma concentration and~     pharmacokinetic profile of the same probe drug after a single dose of an oral solution.~   "
78849|NCT02025335|"~     CMV is one of the most important opportunistic infection in transplant recipients. In South~     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now,~     sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of~     choice to stratify the risk of CMV reactivation after solid organ transplantation.~     Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation~     will further categorize the patients into high or low risk of CMV development after solid~     organ transplantation. The investigators thus evaluate the usefulness of CMV-specific~     ELISPOT assay in kidney transplant candidates to predict the development of CMV infection~     after kidney transplantation.~   "
78850|NCT02025322|"~     This study aims to investigate the effectiveness of an in-person peer mentoring and health~     literacy intervention on improving medication adherence, HIV-1 viral load, CD4+ T lymphocyte~     counts, and HIV medical appointment attendance among newly-diagnosed and/or medication~     non-adherent HIV-positive individuals, compared to standard of care provider/staff-delivered~     education.~   "
78874|NCT02025010|"~     This study is comparing the safety and effectiveness of abiraterone acetate alone, followed~     by the addition of prednisone (when the participant's disease worsens or the physician feels~     it would lessen symptoms of toxicity) versus the current approved treatment regimen which~     involves the concomitant use of prednisone in conjunction with abiraterone acetate.~     Additionally, this study is also examining why participants stop responding to treatment~     with abiraterone acetate by evaluating blood and tissue.~   "
78851|NCT02025309|"~     Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses~     the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows~     its activity by encapsulating these. Likewise, some other steroid hormones and drugs like~     flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that~     methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in~     this study we aimed to compare the recovery times from recuronium-induced muscle relaxation~     after reversal with sugammadex between patients who receive intraoperative~     methylprednisolone or not.~      After institutional review board (IRB) approval and informed consent, 100 patients will be~     enrolled in this prospective, single center, controlled study. Anaesthesia will be induced~     with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance.~     Patients will be divided into two groups (Group M, n: 53 and group C, n: 47,~     methylprednisolone administered group and control group respectively) according to the~     requirement of methylprednisolone administration which is dictated by the type of the~     surgical procedure. Neuromuscular blockade will be monitored using calibrated train-of-four~     (TOF-Carescape B 650 NMT, GE, Connecticut, USA). Once rocuronium-induced neuromuscular~     blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of~     sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to~     0.9 at the ulnar nerve. The time to recovery of TOF to 0.7 and 0.9 will be compared in both~     groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U~     test.~   "
78852|NCT02025296|"~     Recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our~     clinical decision supporting system (CDSS) rule engine, and integrating a physical~     activity-monitoring device and dietary feedback into a comprehensive package. We hypothesize~     that individualized multidisciplinary u-healthcare service combined with exercise monitoring~     and dietary feedback will result in better glucose control with less hypoglycemia in an~     elderly population.~   "
78853|NCT02025283|"~     The aim of this study is to compare early and long term efficacy of lumbar radiofrequency~     nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who~     failed previous conventional therapy. Medical records of 37 patients undergoing targeted~     disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were~     retrospectively examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS),~     Functional Rating Index, Backache index, Oswestry Lumbar Back Pain Disability Index,~     Rolland-Morris Lumbar Back Pain Questionnaire scales were used before treatment and 1,6,12~     months after the procedure. North American Spine Society Satisfaction Scale was used at 12th~     month after the procedure.~   "
78854|NCT02025270|"~     In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic~     patients in a trial to enhance and activate the spermatogonial stem cells of the testis and~     aiming to produce motile sperm.~   "
78855|NCT02025257|"~     The purpose of this study is to investigate the effects of exercise for patients with~     coronary artery disease (CAD) aged 80 years and older, with special reference to maximum~     aerobic capacity, muscle endurance, physical functioning, level of physical activity, health~     related quality of life, anxiety, depression and endothelial function, compared to a control~     group.~   "
78856|NCT02025244|"~     Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of~     esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner~     surface. The prognosis and treatment of these tumors depend on their correct diagnostics and~     mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps~     biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching~     deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the~     diagnostics of Upper gastrointestinal Submucosal Tumors.~   "
78857|NCT02025231|"~     The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to~     patients with recurrent high-grade glioma who have previously received radiotherapy and to~     determine the best dose and treatment regimen. Positron emission tomography (PET) using an~     amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The~     study examines, in four sequential treatment groups, the effect of dose, hypofractionation~     and treatment volume on toxicity. Upon completion of the phase I part, the study progresses~     to phase II where the best dose- and treatment regimen will be chosen for treatment.~   "
78858|NCT02025218|"~     To evaluate the effect of re-administration of gefitinib to EGFR-mutated NSCLC patients who~     had been treated with at least one line of TKIs followed by another line of treatment~     (non-TKI)~   "
78859|NCT02025205|"~     The aim of this prospective, randomized, controlled, one-way crossover study is to assess~     and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in~     patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12~     months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm~     after the 6-month visit and will be followed up for 6 additional months.The primary~     objective is the variation of FEV1 between baseline and 3-month follow-up visit. The~     secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including~     BODE index) changes, target lobe volume reduction, as well as safety outcomes.~   "
78860|NCT02025192|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended~     phase 2 dose (RP2D) of ONT-380 and to assess the safety and tolerability of ONT-380 combined~     with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in~     patients with HER2+ metastatic breast cancer.~   "
78861|NCT02025179|"~     This extension study will only enroll individuals who have completed one year of treatment~     in the parent protocol Effect of Teriparatide, Vibration and the Combination on Bone Mass~     and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055). This study will allow~     those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the~     parent study to be treated for a second year and will allow those individuals who received~     teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy.~     This study will determine if two years of exposure to teriparatide will result in a greater~     increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects~     will be evaluated at 6 and 12 months after initiating treatment with measurement of bone~     density as well as bone markers of formation and resorption.~   "
78864|NCT02025140|"~     • Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness~     of pain control in children can be influenced by child characteristics .~      Objectives: The Purpose of the study is to compare the pain perception and the effectiveness~     of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and~     the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second~     primary molars.~      Materials and Methodology: The study sample includes 90 healthy children who are selected~     randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH)~     with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the~     mandibular second molars. The sample will be divided randomly to one of these 3 groups:~     group A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B~     includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30~     patients will be assigned in group C and will be anesthetized by periodontal ligament~     injection anesthesia using the CCLAD. The pain perception levels after the injection is~     assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step~     in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24~     hours parents will be contacted by the telephone to ask about the presence of postoperative~     pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.~   "
78865|NCT02025127|"~     Septic shock represents the body's dysregulated response to an infection, manifesting as~     persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid~     resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting~     millions of people around the world each year In critically ill patients without shock,~     provision of enteral nutrition within 24-48 hours has shown to preserve intestinal~     epithelium, maintain brush border enzyme activity, maintenance of barrier function to~     enhance immune function, and preservation of tight cell junctions to reduce permeability.~     These benefits of enteral nutrition are postulated to prevent downstream complications of~     nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data~     addressing this question are lacking.~      There is a paucity of data on the timing and role of enteral nutrition in septic shock.~      Specific aim 1: To examine the effect of enteral nutrition of >50 kcal/day but <600 kcal/day~     compared to no enteral nutrition initiated with 24 hours of admission on the number of~     intensive care unit free days' in patients with septic shock.~      Hypothesis 1: The investigators hypothesize that amongst mechanically ventilated patients~     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day~     but <600 kcal/day, as compared to no enteral nutrition, improves the primary outcome of~     number of intensive care unit free days'.~      Specific aim 2: To examine the effect of enteral nutrition of >50 kcal/day but< 600 kcal/day~     initiated with 24 hours of admission on in-hospital mortality, mechanical ventilator free~     days, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy~     in patients with septic shock.~      Hypothesis 2: The investigators hypothesize that amongst mechanically ventilated patients~     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day~     but <600 kcal/day, as compared to no enteral nutrition, decreases mortality, duration of~     mechanical ventilation, time to 50% reduction in vasopressor dose, and time to initiation of~     physical therapy.~   "
78866|NCT02025114|"~     This is an open-label, non-randomized, multicenter phase Ib/II study, which is composed of a~     phase Ib dose escalation part and a phase II dose expansion part. Patients will receive~     selumetinib in combination with gefitinib 250mg daily. This study will enroll EGFR-mutated~     NSCLC patients who have developed acquired resistance to EGFR TKI treatment.~   "
78867|NCT02025101|"~     Description of the phenomena Slow Coronary Flow (SCF), according to the data that has been~     collected from patients hospitalized with specific criteria. Clinical follow-up of these~     patients to determine whether they suffered from any cardial or psychological disorders that~     might be a result of SCF.~   "
78868|NCT02025088|"~     Acne scars have high prevalence, significant impact on quality of life and are a therapeutic~     challenge for dermatologists. Previous studies have shown promising results for the~     treatment of acne scars with non-ablative fractional laser and microneedling, however there~     are no studies comparing the these techniques. Therefore, the objective of this study is to~     compare the effectiveness of treatment of atrophic acne scars on the face with non-ablative~     fractional erbium laser and microneedling.~   "
78869|NCT02025075|"~     The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on~     global and regional (dependent versus nondependent) respiratory mechanics during~     laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences~     intraoperative hemodynamic and cerebral oxygenation.~   "
78870|NCT02025062|"~     The intervention tested in this research project aims to reduce this inequality by improving~     the management of elderly head and neck cancer patients with a specific management. Indeed,~     the treatment of elderly head and neck cancer patients has specificities concerning~     treatment options, their tolerance, psychological management, nutritional and functional~     status, and support needed at home. To assess the overall needs of the elderly patients, an~     assessment known as comprehensive geriatric assessment (CGA) can be performed by a~     geriatrician with extensive testing and questionnaires. This assessment is long and requires~     an experienced geriatrician. It leads to the development of an individualized treatment plan~     (physiotherapy, psychological follow-up, support at home, nutritional management ...) and~     follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA~     utility has been studied in elderly patients with nonmalignant diseases. Studies have shown~     that CGA allowed improving survival and maintaining the elderly at home.~   "
78871|NCT02025049|"~     Inflammation of the pancreas often leads to severe damage not only to the pancreas but also~     to other organs in the abdomen as well as to complications in organs further away like the~     lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe~     inflammation of the pancreas, can mitigate the development of processes that can lead to~     serious complications of this disease.~   "
78872|NCT02025036|"~     A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with~     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But~     in China because of its toxic reaction, most of patients stop the halfway. Because low~     toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely~     used in clinical.~      The purpose of this study is to confirm the difference of Capecitabine plus with or without~     oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for~     esophagus squamous cell carcinoma. A total of 630 patients will be accrued from China within~     2 years. The primary endpoint is overall survival and the secondary endpoints include~     progression-free survival, response rate, pathologic complete response rate and adverse~     events.~   "
78873|NCT02025023|"~     Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection~     of triamcinolone (steroid) and incision and curettage for treatment of chalazia.~   "
78938|NCT02024178|"~     This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients~     undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and~     diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning~     technology for the purpose of determining its ability to identify sites of prostate cancer~     at the time of prostate ultrasound.~   "
78875|NCT02024997|"~     The overall aim of this study is to investigate a novel dual instance planning method to~     make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment~     planning.~      Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and~     expiration (EXP) positions and characterize the changes in geometric relationships between~     the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and~     bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow~     identification of patients who may benefit from the dual instance planning method.~      Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single~     instance breath hold, and the novel dual instance anatomical information. We hypothesize~     that use of the dual instance method will lead to improved plans, demonstrated by the~     ability to increase dose to the target, while maintaining the clinically-accepted normal~     tissue dose constraints.~   "
78876|NCT02024984|"~     INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine~     disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain~     aetiology, but there is strong evidence that it can, to a large degree, be classified as a~     genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal~     disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al.,~     2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the~     etiology of PCOS (Doi et al., 2005).~      It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years~     old). It is thought to be one of the leading causes of female subfertility (Goldenberg and~     Glueck, 2008).~      Its prevalence has increased with the use of different diagnostic criteria and has recently~     been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on~     current Rotterdam diagnostic criteria (March et al., 2010).~      AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene~     citrate to the conventional (late) administration of the same drug in the follicular phase~     as regards ovarian response in PCOS.~      Research Question What is the difference between administration of clomiphene citrate in the~     luteal phase and the follicular phase for ovulation induction in women with PCOS? Research~     Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results~     than conventional administration of clomiphene citrate in the follicular phase as regards~     ovarian response in PCOS.~   "
78877|NCT02024971|"~     The purpose of this study is to investigate the safety and efficacy of long-term use of~     pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in~     patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride~     combined with metformin hydrochloride is considered suitable.~   "
78878|NCT02024958|"~     Energy expenditure (EE) in critically ill patients is highly variable depending on the~     initial severity of the disease and treatments. Clinicians need to measure EE by indirect~     calorimetry (IC) to optimize nutritional support. IC devices available on the market have~     insufficient accuracy for clinical and research use. A new IC is being developed to meet~     these needs.~      Objectives: Validation of a reliable and easy-to-use IC device.~      Primary objective:~      • Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC~     devices in intubated ICU patients on mechanical ventilation~      Secondary objectives:~        -  Accuracy of EE measurements in ICU patients of spontaneous breathing~        -  Accuracy of EE measurement during ~30 min. vs. the sum of 6 periods of 60 min/12 hrs~        -  Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation~      Design: Prospective, controlled, observational multicenter study.~      Subjects: 182 ICU patients.~   "
78879|NCT02024945|"~     The purposes of this study were to assess Quality of Life (QoL) and urination urge,~     incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment~     with propiverine.~   "
78880|NCT02024932|"~     The purpose of this study is to determine if BVS857 is safe, tolerable and increases thigh~     muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).~   "
78881|NCT02024919|"~     Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of~     epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE~     constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in~     which coronary artery stenosis or severe valvular heart diseases are not present. CAE~     represents not only an anatomical variant but also a clinical constellation of coronary~     artery disease (CAD) like association with myocardial ischemia and acute coronary syndromes.~     Patients with CAE without significant coronary narrowing may still present with angina~     pectoris, positive stress tests, or acute coronary syndromes. Impaired epicardial and~     microvascular perfusion were demonstrated in ectatic coronary arteries.~      Myocardial blush grading (MBG) technique has been utilized in various conditions such as~     acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated~     cardiomyopathy to evaluate myocardial perfusion.~      There is still no consensus for management of CAE. Previously improvement of coronary flow~     has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is~     needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem~     improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent~     has been widely used in coronary catheter labs to prevent and treat no-reflow.~      The current study with prospective design was therefore set up to assess whether epicardial~     flow and tissue level perfusion would be improved by diltiazem in myocardial regions~     subtended by the ectatic coronary arteries among patients with isolated CAE.~   "
78882|NCT02024906|"~     The purpose of this study is to help the researchers understand if using a soy supplement~     impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.~   "
78883|NCT02024893|"~     -  Shoulder pain and dysfunction are common problems in overhead sports, due to extreme~          ranges of motion and repetitive loading. Predisposing factors include inadequate range~          of motion (ROM), such as a reduction in total ROM or a shift of balance between~          internal and external rotation. Such a shift may be the result of soft tissue~          adaptations to the activity demands, or reflect a structural outcome of Humeral~          retroversion. A shift in the range of motion may be detrimental to the rotator muscle~          function, which may create another risk factor for shoulder injury.~        -  The purpose of this study is to document shoulder range of motion, humeral~          retroversion, rotator muscle strength and fatigue in several groups of overhead~          athletes undergoing a routine pre season screening once a year, and investigate the~          interaction between those factors in the different groups.~   "
78884|NCT02024880|"~     In-vitro fertilization (IVF) treatment involves development of multiple follicles following~     ovarian stimulation, oocyte retrieval and embryo transfer (ET). ET is the final and most~     crucial step of IVF treatment.~      The ET catheter has to pass through the endocervical canal to go into the uterine cavity~     through the internal os. The endocervical canal may be filled up with mucus or blood.~     Embryos trapped in the mucus or blood after the passage of the endocervical canal may not be~     able to implant into the endometrium. Guardia™ Pro Protective ET catheter is designed to~     allow the safe passage of embryos through cervical mucus and blood as its outer sheath~     protects the embryo through entry and then opens in petals to further advance the inner~     catheter and gently place the embryo.~      The hypothesis of this study is that the pregnancy rate is significantly higher after ET~     using protective ET catheters.~   "
78885|NCT02024867|"~     The objective of this study is to determine if there is a difference in treatment failures~     and recurrent skin infections when patients are given 3 or 10 days of antibiotics for~     uncomplicated skin abscesses after they have been surgically drained.~   "
78886|NCT02024854|"~     The aim of the study is to investigate physiological response, social/emotional response and~     general movements in preterm infants when they are given skin-to-skin contact with the~     mother (intervention) or standard care (incubator) right after delivery. Preterm infants~     will be randomized to either intervention or standard care group. Data on body temperature,~     blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In~     addition the infant will be video-recorded during the first 24 hours and at three months of~     age for analysis of the general movements.~   "
78887|NCT02024841|"~     Phase I study on the maximum tolerated dose (MTD) and the recommended dose (RD) of~     intraperitoneal docetaxel combined with intravenous cisplatin and oral TS-ONE in gastric~     cancer patients with peritoneal carcinomatosis~   "
78888|NCT02024828|"~     The purpose of this study was to test the effect of four randomly assigned approaches to~     oral feeding transition on feeding outcomes in preterm infants.~   "
78889|NCT02024815|"~     Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma~     (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in~     the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is~     achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized~     trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and~     recalcification for patients with painful bone metastases from solid tumors. The role of~     different palliative radiotherapeutic regimens for MM is not well established due to lack of~     clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic~     regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.~   "
78890|NCT02024802|"~     There has been a significant increase in the number of prescriptions being filled for Custom~     Compounded Pain Creams. This study serves to evaluate the patient perception and~     satisfaction with this type of pain therapy allowing us to identify any statistically~     relevant relationships that may exist between this type of therapy and patient pain~     perception. A secondary goal would be to identify any significantly relevant relationships~     that may exist between this change in pain perception (if any) and the patients overall~     sense of well-being. The investigators' null hypothesis is that greater that 85% of people~     will see an significant decrease in perceived pain levels and greater than 85% increase in~     patient overall sense of well being.~   "
78891|NCT02024789|"~     This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study~     will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down~     syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or~     placebo orally twice daily for 26 weeks.~   "
78892|NCT02024776|"~     Despite recent advances, morbidity and mortality associated to major abdominal surgery is~     significant. A poor physical condition and functional status reduces the ability of a person~     to cope, mentally and physically, with hospitalization and surgery and may compromise~     functional recovery, potentially leading to postoperative complications and death.~     Prehabilitation aims to enhance functional capacity preoperatively for better toleration of~     surgery and to facilitate recovery and eventually the prognosis of the surgical patient.~     Whereas the benefits of cardiopulmonary fitness programs are well established, the~     accessibility, sustainability of effects, and impact on the surgical outcome of these~     programs are unsolved issues. Wellness programs based on integrated care services supported~     by Information and Communication Technology (ICT) can overcome such limitations. The~     investigators hypothesized that a prehabilitation program, inducing beneficial effects on~     exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT~     support may contribute to increase the adherence and sustainability of this intervention.~   "
78893|NCT02024763|"~     The aim of this study was to evaluate the impact of a classroom teachers' educational~     intervention on 1st and 2nd grades children's physical activity level and energy expenditure~     during physical education classes in elementary public schools, in São Paulo, Brazil.~   "
78908|NCT02024568|"~     Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens.~     Its use is frequently associated with moderate to severe muscle and joint pain that may~     persist for several days after the treatment. This side effect, known as Arthralgia-Myalgia~     Syndrome, has a significant impact on the quality of life and functional abilities of those~     receiving the treatment, and is not alleviated by many of the interventions attempted for~     that purpose.~      Sporadic reports suggest that a drug called gabapentin may be effective in the management of~     this adverse effect. Observations from our practice indicate that pregabalin, which~     possesses similar biological activity to that of gabapentin, may also be useful in~     preventing and treating paclitaxel associated myalgia - arthralgia.~      The current study represents an initial evaluation of the hypothesis that pregabalin may be~     beneficial in the management of the symptoms due to the Arthralgia-Myalgia Syndrome. The~     investigation will be carried out in the format of a small scale, randomized, placebo~     controlled trial with patients receiving paclitaxel in the course of standard treatment for~     breast cancer.~   "
78909|NCT02024555|"~     The primary purpose of this study is to investigate the efficacy and safety of oral~     antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We~     suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic~     pulmonary sarcoidosis participants.~   "
78894|NCT02024750|"~     Children with type 1 diabetes face complex self-management regimens which make adherence~     challenging and ultimately result in poor blood sugar control. Several common barriers~     interfere with diabetes control such as limited knowledge or challenges with staying~     motivated. Efficacious strategies exist to improve diabetes self-management including, but~     not limited to, diabetes education or family therapy. Patients and families often do not~     access these strategies, in part due to healthcare systems-based issues such as~     accessibility, provider availability, or insurance coverage.~      A family-centered approach has been suggested to tailor diabetes care to provide improved~     outcomes for each child. Family-centered care engages the family in the decision-making~     about the child's health and well-being. In this study we will take a family-centered~     approach to providing diabetes self-management by identifying families' unique~     self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition~     in Illness Self-Management). Based upon the results of PRISM, we will provide tailored~     self-management resources (interventions) to meet the family's needs. We will coordinate~     group-based delivery of the resources with routine diabetes clinic visits. These group-based~     resources will be delivered in four 75-minute sessions over a year.~      The primary goal of this study is to compare the effectiveness of family-centered tailoring~     of diabetes self-management resources with the untailored approach of usual care. We~     hypothesize that the family-centered model of care with tailored resources will improve the~     outcomes of glycemic control and quality of life among children with type 1 diabetes and~     their parents.~   "
78895|NCT02024737|"~     Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of~     disease and death worldwide, affecting those in both developed and developing countries.~     This imparts a massive burden of ill health, in turn imposing huge healthcare costs to~     society.~      For effective treatment of COPD (as opposed to providing short term relief) early disease~     must be targeted. The small airways of the lung (those less than 2mm) are the first affected~     in COPD, but current methods to assess their function are relatively insensitive. There is~     therefore a need for new, accurate methods for detection of small airway dysfunction with~     sensitivity to shortterm change and regional discrimination.~      In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and~     patients with early stage COPD, we showed sensitivity to early changes in lung ventilation~     and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of~     ionizing radiation permits patients to be imaged on multiple occasions. This and its~     inherent sensitivity to regional lung ventilation and function make it an ideal imaging tool~     for the assessment of novel lung therapies for diseases of the small airways.~      The purpose of this pilot study is to determine short and long term reproducibility of a~     comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI~     and lung physiology measurements in patients with moderate to severe COPD.~      In addition,how sensitive the imaging techniques are to changes in lung function after~     treatment with a standard (bronchodilator) inhaler will also be assessed.~      This pilot study will serve as a platform for future larger scale studies, aimed at better~     understanding of and intervention in early COPD.~   "
78896|NCT02024724|"~     Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by~     unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal~     nerve. Current treatment strategies include oral medications as first line therapy with~     surgical interventions reserved for those patients who are refractory to medications or~     unable to tolerate medication side effects. Despite these current treatment options, many~     patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine~     adjustment of the needle tip and direct observation of the medicine.~      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic~     nerve pain with great success. Steroids can be short or long acting in duration with varying~     side effects. If there exists a difference in duration of action, using the longer acting~     drug will provide a greater period of symptom relief for the patient and may allow the~     patient to undergo fewer interventional procedures.~   "
78897|NCT02024711|"~     The purpose of this multicenter, prospective, randomized clinical study is to determine the~     safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract~     extraction and intraocular lens (IOL) implantation surgery.~      EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal~     endothelium and other intraocular tissues, and to manipulate tissues during surgery.~      EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments~     during cataract extraction and intraocular lens insertion.~   "
78898|NCT02024698|"~     The objective of this study is to compare the clinical performance of ProClear 1-Day versus~     1-Day Acuvue Moist each for one week of daily disposable wear.~   "
78899|NCT02024685|"~     This is a psychosocial/behavioral study and does not involve administration of any treatment~     or diagnostic procedures. We will use a randomized trial to test the hypothesis that a~     decision analysis model that provides individualized estimates of quality-adjusted~     disease-free survival for each of the treatment options for clinically localized prostate~     cancer will lead to higher quality treatment decisions congruent with a patient's values~     leading to improved decisional regret and treatment satisfaction. In this trial, all~     patients would be evaluated at baseline for their utilities for various clinically important~     health states. The control arm will receive counseling regarding treatment options using~     standard patient-physician interactions and nomogram-predicted probabilities of treatment~     outcome for the various treatment options and they will be unaware of the decision analysis~     recommendation. The treatment arm would be counseled using standard patient-physician~     interactions and they would also be provided with a personalized treatment recommendations~     based on the decision analysis model prior to treatment selection. The primary endpoint of~     this study will be regret-free survival at 2 years after treatment. There will be a 1:1~     randomization. A random permuted design will be used to assure approximate balanced number~     of patients in the two groups over time.~   "
78910|NCT02024542|"~     Research the genetic and biomechanical markers of human adipose tissue on patients with~     morbid obesity. Additional tissue/fluid collection is also gathered during the time of~     surgery.~   "
78939|NCT02024165|"~     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and~     maternal heart rate and contraction monitor that is unaffected by obesity and requires less~     nursing intervention than the tocodynamometer and Doppler ultrasound.~   "
78900|NCT02024672|"~     Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception,~     and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.~     IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal~     or cesarean birth. This practice has been shown to be safe, and is recommended by the~     American College of Obstetricians & Gynecologists, the World Health Organization and the~     U.S. Center for Disease Control. Immediate postpartum IUD placement has the advantage of~     providing contraception at a time that the woman is already accessing medical care, avoiding~     potential loss to follow up or risk of unintended pregnancy. Additionally, women who have~     anesthesia for delivery have reduced pain at the time of IUD placement compared to having~     the IUD placed at the postpartum follow up appointment. Immediate postpartum IUD placement~     is a relatively new practice in the US and little is known about the expected appearance of~     IUDs inside the uterus taken with an ultrasound when they have been placed at the time of~     delivery. It is less likely that IUD strings will be visible at the cervix after immediate~     postpartum IUD placement due to subsequent uterine involution, which makes it important to~     monitor correct positioning of the IUD via ultrasound. This study will document normal~     changes in the positioning of the IUD visualized via ultrasound, and determine if a~     correlation exists between IUD position and risk of expulsion. Ultrasound surveillance to~     document IUD position and distance from the fundus, will be performed at 6 weeks, 3 months~     and 12 months after placement. Symptoms of menstrual bleeding and pain will also be recorded~     in order to determine if they are correlated with IUD position.~   "
78901|NCT02024659|"~     This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with~     eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation~     suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic~     polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp~     samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and~     tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry;~     and frequencies of different inflammatory T cell infiltration by flow cytometry. this study~     is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation~     suspension via transnasal nebulization by clinical and immunologic assessments. As outcome~     parameters for remodeling, differences in the expression of collagen and albumin were~     investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs~     expression differences in nasal polyps were investigated to explore underlying mechanisms of~     tissue reconstitution.~   "
78902|NCT02024646|"~     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to~     placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate~     the efficacy of brodalumab compared to placebo at week 16. The safety objective of this~     study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.~   "
78903|NCT02024633|"~     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable~     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic~     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in~     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic~     pancreatic adenocarcinoma.~   "
78904|NCT02024620|"~     Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for~     increasing the adherence of individuals to psychotherapy treatments which may subsequently~     increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for~     real-time tracking of behavior and have the ability to provide prompt feedback and reminders~     in a convenient, readily available technology. The immediacy and convenience of apps may be~     responsible for the observed improvements in adherence on the part of the patients relative~     to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy.~     These features are relevant to behavioral activation (BA) protocols, the effects of which~     are often attenuated by failure to adhere to regular practice and tracking of behavior. The~     Mood Coach app is a BA protocol developed to provide a convenient means of planning and~     tracking activity, and monitoring mood responses to scheduled increases in activity. This~     project evaluates the utility of this app as an adjunct to standard BA treatment. The~     investigators predict that participants assigned to the BA+app condition will demonstrate~     greater adherence to the BA treatment compared to the standard BA condition. The~     investigators also predict that the participants in the BA+app condition will report greater~     satisfaction with the app compared to the standard BA protocol that utilizes paper and~     pencil materials.~   "
78905|NCT02024607|"~     This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered~     in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with~     and without bevacizumab, or regorafenib, or irinotecan.~   "
78906|NCT02024594|"~     Visiting anxious and fearful children is an inevitable prospect of the daily work of every~     dentist who treats pediatric patients. Dentists have been using a wide variety of~     non-pharmacological and some pharmacologic techniques to assist them in the management of~     children with anxiety. One strategy which seems promising for pain control in stressful~     medical situations is teaching the child to use behavioral and cognitive coping skills or a~     combination of both techniques. An alternative technique to non-pharmacologic approaches in~     children being anxious and lacking in cooperative ability is sedative technique such as~     nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation~     and combinations of cognitive-behavioral strategies in eliminating children's uncooperative~     behaviors and dental anxiety, the aim of this study was to compare the effectiveness of~     inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral~     therapy to reduce dental anxiety in preschool children.~   "
78907|NCT02024581|"~     This trial will examine the safety, tolerability and efficacy of one strength of East Indian~     sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum~     contagiosum in pediatric subjects. Trial participants will be asked to apply study~     medication twice a day for sixty (60) days. Efficacy will be evaluated by clinical staff and~     patients will be asked to assess tolerability as well as any improvement experienced during~     the trial.~   "
78937|NCT02024191|"~     Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal~     cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we~     aimed to determine whether glutamine has role in prevention of oxaliplatin induced~     neuropathy.~   "
78911|NCT02024529|"~     This is a randomized, placebo-controlled, double-blind study in which 500 patients with~     osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20~     weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits~     at 6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment~     of disease severity (PGA). Safety will be assessed by recording adverse events, concomitant~     medications, physical examination, vital signs and clinical laboratory tests.~   "
78912|NCT02024516|"~     The aim of this study is to examine the effects of concentrated pomegranate juice on serum~     lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients~     aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day~     concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements,~     3-days food-record questionnaire ,physical activity and fasting blood samples were collected~     at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a,~     IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The~     participants are asked not to change their regular diet, medicine and activity during the~     study.~   "
78913|NCT02024503|"~     Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/~     perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of~     patients with acute ischaemic stroke for trials of intervention. The investigators want to~     apply multimodal resonance imaging methods such as functional magnetic resonance imaging (~     fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and~     predict the prognosis of stroke.~   "
78914|NCT02024490|"~     Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease,~     is the most common cause of respiratory distress in premature infants, correlating with~     structural and functional lung immaturity. The pathophysiology of RDS is complex. Immature~     type II alveolar cells produce less surfactant that causes an increase in alveolar surface~     tension and a decrease in compliance. This resultant atelectasis lead to pulmonary vascular~     constriction, hypoperfusion, and lung tissue ischemia. RDS and prolonged ventilation and~     associated systemic/lung injury may also contribute to long term oxygen dependency and may~     result in bronchopulmonary dysplasia (BPD). Vitamin D is a fat-soluble steroid hormone that~     primarily contributes to the maintenance of normal calcium homeostasis and skeletal~     mineralization. In addition to its classical role in bone metabolism, vitamin D deficiency~     has been associated with impaired pulmonary function, increased incidence of viral and~     bacterial infections and inflammatory lung diseases. Although exact mechanisms are not fully~     understood, vitamin D appears to impact on a variety of inflammatory and structural cells~     within the lung including macrophages, lymphocytes and epithelial cells. To our best of~     knowledge, no study has evaluated the effect of vitamin D levels on the severity and~     presence of RDS in preterm infants. Therefore, the aim of this study is to evaluate the~     possible role of maternal/neonatal vitamin D levels on RDS development in preterm infants.~     We also aim to determine the possible association between maternal/neonatal vitamin D levels~     and the incidence of BPD and other neonatal morbidities.~   "
78915|NCT02024477|"~     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels~     which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the~     blood . Research has shown that improving the survival of these special blood cells may~     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart~     disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine~     used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is~     in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown~     to increase EPCs in patients with Type 2 diabetes.~      Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately~     affects the repair and regeneration of the endothelium and that prompt intervention using~     saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse~     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose~     metabolism control.~   "
78916|NCT02024464|"~     This clinical trial compares two implantable devices intended to lower the pressure inside~     the eye of glaucoma patients. One of the two devices will be implanted immediately following~     cataract surgery and the placement of a posterior chamber intra-ocular lens.~   "
78917|NCT02024451|"~     Myofascial pain syndrome is common in Rehabilitation clinic. The pain occurs asymmetrically~     in isolated or regional muscles, and is associated with acute muscle strain or chronic~     muscle overuse. Myofascial pain is characteristics with localized muscle tenderness,~     palpable intramuscular taut band, typical referred pain, and local twitch response.~      Treatment of myofascial pain syndrome includes physical therapy, stretch exercise, dry~     needle insertion and trigger point injection. Acupuncture originated from ancient Chinese~     medicine which involves the insertion of fine needle to stimulate specific points of the~     body along the 12 meridians. The mechanism of pain relief may be initiated by activation of~     both spinal segmental and supraspinal centers. Acupuncture is commonly used for pain relief.~      Recently, radial shock wave has been shown to be effective in the treatment of chronic~     musculoskeletal pain, including calcific tendinitis, epicondylitis, and plantar fasciitis.~     The energy and pressure produced by radial shock wave is focused on the treated~     musculoskeletal tissue. The mechanism of action has been hypothesized that the energy could~     result in analgesic effect and stimulation of angiogenesis and healing response and then~     relief of the symptoms. The effectiveness of radial shock wave on treatment of myofascial~     pain was reported by Jeon and colleagues in 2012.~      The aim of this study is to compare the efficacy of acupuncture and radial shock wave~     therapy in patients with myofascial pain syndrome.~   "
78918|NCT02024438|"~     For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for~     chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse~     effects which even result in discontinue of chemotherapy, especially for patients suffered~     from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of~     membrane of nerve cells. Previous phase II clinical trial showed, it can reduce~     oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. A~     phase III trial is needed to investigate the effect and safety of~     monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.~   "
78919|NCT02024425|"~     The purpose this study is to evaluate the therapeutic effect of a functional bioactive~     supplement associated with a hypocaloric equilibrated diet to treat obese and overweight~     individuals. The functional bioactive supplement, containing antioxidant extracted from~     rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to~     satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms~     as well as to weight loss.~   "
78920|NCT02024412|"~     The morbidity of colorectal cancer(CRC) is 10%～15% in China.mFolfox6 has become one of the~     standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and~     oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in~     discontinue of chemotherapy, especially for patients suffered from heavily acute~     neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells.~     Previous phase II clinical trial showed, it can reduce oxaliplatin-induced~     neurotoxicity(OIN). But it did not certificated by phase III trial. Investigators designed~     the phase III trial to investigate the effect and safety of monosialotetrahexosylganglioside~     Sodium Injection for prevention OIN at colorectal cancer.~   "
78921|NCT02024399|"~     This project will address the important area of childhood obesity and the risk of~     cardiovascular disease associated with obesity. This is a serious health concern since~     children who are overweight or obese are prone to other medical conditions including high~     blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition~     programs are recommended, evidence for the efficacy of these programs in improving~     cardiovascular health is lacking.~      Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels,~     c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to~     exercise and a healthy lifestyle change both during and beyond the conclusion of the~     program.~      Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week~     multidisciplinary fitness and nutrition program will show significant improved levels of~     cardiovascular risk factors.~      Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when~     compared with a matched, WLC group will show a change in whole body assessment including a~     decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body~     fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to~     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness~     and nutrition program will show improved whole body assessments including.~      Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when~     compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to~     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness~     and nutrition program will show significant improvements in fitness including.~   "
78922|NCT02024386|"~     During ascent to high altitude there is a physiologic response to hypoxia that results in an~     elevated pulmonary arterial pressure associated with decreased exercise performance,~     altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat~     is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in~     the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of~     altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy~     volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated~     pulmonary artery pressures found in conditions of high altitude, allowing observation of the~     effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and~     exercise performance. Prior to entering the hypobaric chamber, subjects will have radial~     arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery~     pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise~     tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer~     (exercise bike) before and after administration of riociguat. If, after administration of~     riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is~     improved and observed pulmonary artery pressures are lower than those measurements seen~     prior to administration of riociguat, this could lead to development of a prophylactic~     and/or treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical~     analysis will compare the variables of pulmonary artery pressure, radial arterial pressure,~     ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after~     administration of the drug riociguat. The investigator's hypothesis is that riociguat will~     decrease pulmonary artery pressure and improve gas exchange and exercise performance at~     altitude.~   "
78923|NCT02024373|"~     To evaluate the clinic effects and security of oral administration of Atorvastatin on~     chronic subdural hematoma (CSDH).~   "
78924|NCT02024360|"~     The purpose of this research is to investigate the effectiveness of a community health~     worker-based program as an adjunct to clinical services regarding childhood obesity~     management. This family-centered program will be delivered in the community and homes of~     enrolled families. The primary outcome will compare change in age-gender specific~     body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will~     be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month~     stepped wedge engagements. The intervention lasts for 6 months and the time prior to~     engagement in the intervention will serve as the control period. Intervention construct~     validity will be evaluated using data on diet, activity, and fitness. The primary goal is to~     examine the effect of the intervention in reducing the zBMI in the index patient and~     secondarily on any participating family members. We will test effectiveness among~     demographic groups under-represented in prior studies, including very young children and~     Latinos. Results from this study will inform future intervention modifications and permit~     effect size estimation and power calculations for future randomized trials that include a~     community health worker-based obesity prevention and treatment program. During the course of~     the study, an obesity registry will be designed and implemented within an integrated~     safety-net healthcare system to measure primary obesity outcomes in a low-income population~     and conduct analyses. The community health worker will be using several new technologies~     (e.g., text messaging and patient relationship manager [PRM]) as an adjunct when working~     with an obese child and his/her family. Targeted training for clients, providers and CHW~     will be part of the prevention strategies implemented during the grant period, these will~     include motivational interviewing. All of these (i.e., obesity registry, technologies and~     training) will have an evaluative component.~   "
78925|NCT02024347|"~     Liver cirrhosis is an advanced stage of chronic liver diseases, which is often associated~     with various complications, namely esophageal and/or gastric varices, ascites,~     hepatocellular carcinoma (HCC). It is well known that the risk of complications varies even~     among cirrhotic patients, as those with more advanced disease would have more complications~     and poorer survival rates. Liver stiffness measurement (LSM) with transient elastography is~     found useful to identify cirrhotic patients with higher risk of portal hypertension and~     presence of varices . Recently, spleen stiffness measurement (SSM) with the same machine was~     found accurate to predict portal hypertension and esophageal varices.~      Investigators hypothesized that a new screening strategy guided by LSM and SSM (LSSM) values~     (LSSM-guided) is non-inferior to conventional strategy in terms of detection rate of~     clinically significant esophageal and/or gastric varices for patients with liver cirrhosis~     in an open-labeled randomized controlled trial.~      Consecutive patients with compensated liver cirrhosis will be invited for the study.~     Patients fulfilling the study criteria will be randomized into LSSM arm (upper endoscopy~     only performed to patients with high LSM or SSM values), and control arm (upper endoscopy~     performed to all patients). Patients randomized into LSSM arm will undergo transient~     elastography examination; those with high LSM or SSM results will be referred for upper~     endoscopy examination for to screen varices. Patients randomized into control arm will be~     directly referred for upper endoscopy examination.~   "
78926|NCT02024334|"~     A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of~     refractory juvenile idiopathic arthritis.~      Patients are randomly divided into two groups. In group 1 leflunomide and in group 2~     placebos will be added to conventional treatment for three months. therapeutic responses~     will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4~     weeks.~   "
78927|NCT02024321|"~     The purpose of this study is to determine the relationship among TPN, tumor and blood~     glucose.~   "
78928|NCT02024308|"~     The purpose of the study is to determine whether Fludarabine in combination with cytarabine~     is more effective than high-dose cytarabine in post-remission therapy for patients with~     AML1-ETO acute myeloid leukemia.~   "
78929|NCT02024295|"~     To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with~     cholestasis.~   "
78930|NCT02024282|"~     Acute illness is the most common presentation of children attending ambulatory care~     settings. Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare,~     but their impact is quite large (increased morbidity, mortality, induced fear in parents and~     defensive behaviour in clinicians). Early recognition and adequate referral of serious~     infections are essential to avoid complications (e.g. hearing loss after bacterial~     meningitis) and their accompanied mortality. Secondly, we aim to reduce the number of~     investigations, referrals, treatments and hospitalisations in children who are diagnosed~     with a non-serious infection. Apart from the cost-effectiveness, this could lead to less~     traumatic experiences for the child and less fear induction for the concerned parent.~     Finally, we aim to support the clinicians to rationalise their antibiotic prescribing~     behaviour, resulting in a reduction of antibiotic resistance in the long run.~   "
78931|NCT02024269|"~     This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC)~     implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using~     local anesthesia and syringe collection will be performed to collect the adipose tissue~     specimen for subsequent processing to isolate the stem cells. The cells will be delivered~     via needle injection into the eye.~   "
78932|NCT02024256|"~     The purpose of this study is to compare the impact of treatment with cooled magnesium~     sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.~      Assessment of appropriateness for each patient to take part in the study will be performed~     approximately 2 hours following delivery. Those patients who consent to participate in the~     trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in~     the study group will receive treatment with pads soaked in a cold aqueous solution of~     magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive~     treatment with pads soaked in cold water.~      Nurses will initiate treatment according to the group to which the patient was randomized.~     Said pads will be given the patients routinely 5 times a day at regular times.~      A physician will assess the perineal swelling according to visual (photographed) scale in~     which severe, moderate, light and no swelling will be defined. Measurement of swelling in~     centimeters (maximal length and breadth); photography, by a medical photographer or the~     examining doctor, of the perineal area with a centimeter ruler, before, during and after~     treatment (photography is dependent on patient approval and is not a precondition to~     participation in the trial.); and additional examination, on the above basis, will be~     performed regarding hemorrhoids in the event that a patient has complained of such.~      A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to~     the patient being given the pad and an hour following treatment. An additional assessment by~     the same method will be performed regarding hemorrhoid pain. Any analgesia administered will~     also be recorded.~      Likewise, for follow-up purposes a blood test for serum magnesium concentration will be~     taken before and after treatment.~      Period of follow-up will be 48-72 hours from childbirth.~   "
78933|NCT02024243|"~     Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound~     edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing~     outcome in a setting of standard clinical care.~      Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human~     wound edge tissue is associated with poor healing outcome in a setting of standard clinical~     care.~      This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled~     diabetic, and, who have chronic venous leg ulcers, that are not infected and have been~     open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be~     recruited from the OSU Wexner Medical Center Comprehensive Wound Center (CWC). On days 0, 14~     and 28, patients will have the following performed: measurements and photographs taken of~     their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen~     in the wound tissue; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will~     not be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical~     records will be reviewed throughout the study to obtain information about the patient (age,~     sex, race/ethnicity, current medications, TCOM, would location and type, other~     illness/diagnoses, wound care treatment and instructions, nutritional status based on~     albumin levels), and at 14 weeks after enrollment to determine the final status of the wound~     (healed or not healed).~      There will be a total of 5 visits for this study (6 total visits for patients with open~     wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21 and 28.~   "
78934|NCT02024230|"~     Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who~     underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the~     prevention of cardiogenic embolism including cerebral infarction in AF patients. However,~     the combined antithrombotic therapy has been reported to increase the risk of major bleeding~     for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with~     other drugs and do not need frequent blood tests have become commonly used. The purpose of~     this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the~     efficacy and safety for AF patients after coronary stenting.~   "
78935|NCT02024217|"~     To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in~     Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary~     endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety~     of regime, disease free survival(DFS) and overall survival(OS).~   "
78936|NCT02024204|"~     The purpose of this study is to understand why patients in the World Trade Center program~     have continuing breathing problems. This study will improve investigators understanding of~     breathing problems among individuals with World Trade Center exposure by allowing them to~     review and monitor medication use, lung function, and examine other conditions that can~     contribute to problems with breathing. The findings from the study will help investigators~     understand why some people have persistent lower respiratory symptoms (breathing problems)~     after their exposure to World Trade Center dust and fumes, and may help guide better~     management and treatment of these symptoms.~   "
80291|NCT02006485|"~     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in~     combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with~     advanced hematologic malignancies~   "
78942|NCT02024126|"~     Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult~     population, and approximately 800 000 people in Sweden (population of 9 million people)~     suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and~     sick leave. There is increasing evidence that exercise therapy is effective for patients~     with knee OA. However, there is little knowledge on long-term effects and what type of~     exercises dosage is most effective. In this present clinical trial, which is a Nordic~     collaborative project with researchers from different research groups in Sweden and Norway,~     we intend to investigate short and long-term effects comparing high dosage exercise therapy~     (each treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30~     min) in patients diagnosed with knee OA. Patients in both intervention groups receive three~     treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is~     pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)).~     Secondary outcome concerns various health-ratings and objective functional tests. Regarding~     predictors for outcome, we plan also to investigate different psychosocial variables as well~     as patient's beliefs regarding exercise.~      Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo),~     and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from~     primary health care settings, two in Norway and two in Sweden, with radiographic-verified~     knee OA with knee pain and decreased function. The patients have to be within the 45 to 85~     age group. Patients are excluded if they have been scheduled for knee surgery or have some~     other form of illness/disease that limits the exercise tolerance (e.g. heart disease or~     systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to~     grade exercises so that they are performed pain-free or close to pain-free in both~     intervention groups. The principle of deloading is used to meet this goal using a high~     number of repetitions in sets as pain modulation. The results from this study will give new~     information about the effectiveness of graded exercise therapy in patients with knee OA, and~     new knowledge if outcome can be related to the exercise dosage performed.~   "
78943|NCT02024113|"~     Lung cancer is the most common cancer in men and the fourth most common cancer in women~     worldwide. Until today no effective method permits the early detection of lung cancer.~     Consequently, lung cancer is often diagnosed owing to symptoms of advanced disease. To~     address this problem, detection methods with an improved sensitivity and specificity are~     urgently needed.~      Over the past decade, accumulating evidence shows that the metabolism of cancer cells~     differs from that of normal cells. More specifically, the entire metabolism of cancer cells~     is reorganized or reprogrammed to increase anabolic reactions that induce cell growth and~     survival. Metabolic reprogramming during the development of cancer is driven by aberrant~     signaling pathways due to the activation of oncogenes and the loss of tumor suppressor~     genes. Furthermore, the microenvironment of the tumor plays a role in metabolic~     reprogramming. The altered cancer metabolism is characterized by an increased glycolysis,~     the production of lactate and the biosynthesis of macromolecules, such as proteins, lipids~     and nucleotides. Cancer cells have a high glycolytic rate and eliminate most of the~     glucose-derived carbon as lactate rather than oxidizing it completely via oxidative~     phosphorylation, a phenomenon known as the Warburg effect. The breakdown of glucose and~     other nutrients leads to a high energy production and provides the Krebs cycle with~     intermediates, which consequently are allocated to metabolic pathways that support~     biosynthesis. Metabolites are the end products of cellular metabolism and are therefore~     closely related to the observed phenotype. Disturbances in biochemical pathways which occur~     during the development of cancer consequently provoke changes in the metabolic phenotype. As~     a result, low-molecular weight metabolites are very attractive biomarkers for different~     cancer types. Nuclear magnetic resonance (NMR) spectroscopy enables the identification and~     quantitative analysis of complex mixtures of metabolites, as in plasma and serum, without an~     extended sample preparation.~      The present study aims to determine the metabolic phenotype of lung cancer by means of~     proton (1H)-NMR spectroscopy. Once the phenotype determined (training cohort), this has to~     be validated by an independent cohort.~   "
78944|NCT02024100|"~     The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive~     patients with metabolic syndrome~      -Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure~     produced one heart beat.~   "
78945|NCT02024087|"~     The purpose of this study is to evaluate the safety and tolerability of dalantercept plus~     sorafenib in patients with advanced hepatocellular carcinoma (HCC) to determine the~     recommended dose level of dalantercept in combination with sorafenib.~   "
78946|NCT02024074|"~     The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular~     Breast Imaging as an imaging modality for breast cancer screening.~      Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the~     detection of breast cancer among high risk women when compared to mammography. However,~     there is little published data comparing Tc-MBI to MRI for evaluating extent of disease in~     women with known breast cancer.~      The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled~     to undergo biopsy of additional suspicious lesions that were identified on standard of care~     contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI~     scan of the breast. The results from both imaging methods will be compared to histological~     findings. These results may be used to design larger and more comprehensive studies with an~     overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation~     of patients with known breast cancer.~   "
78947|NCT02024061|"~     The purpose of this study is to analyse if a multidisciplinary approach including peers is~     effective in the treatment of obesity in adolescence.~   "
78948|NCT02024048|"~     The purpose of this study is to evaluate choroidal thickness and volume during the third~     trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group~     of women~   "
78949|NCT02024035|"~     The purpose of this study is to do health economic evaluation of tomotherapy and dynamic~     arctherapy (2 techniques exist: RapidArc and Vmat).~      This study evaluate also local disease control after 18 months in patients with an ENT~     epidermoid carcinoma and treated by tomotherapy orarctherapy .~      The number of patients required in this study is: 300:~        -  Number of patients treated with tomotherapy: 120~        -  Number of patients treated with dynamic arctherapy RapidArc: 120~        -  Number of patients treated with dynamic arctherapy Vmat: 60~      This is a prospective; multicentric and non randomized study.~   "
78950|NCT02024022|"~     This study aims to compare a standard approach to bowel preparation for colonoscopy (using~     sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients~     are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG~     depending on patient-related factors. The study aims to compare patient-related outcomes~     such as comfort levels during bowel cleansing and physician-related outcomes such as bowel~     prep quality in the two study groups.~   "
78967|NCT02023801|"~     This is a clinical study without a formal hypothesis. The primary objective of the study is~     to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to~     normal menstrual blood loss at 12 months post-treatment, in premenopausal women with~     menorrhagia due to benign causes for whom childbearing is complete or no longer wish to~     retain fertility.~   "
78968|NCT02023788|"~     This is a 5-year long-term follow-up study of open label, single-center, phase I clinical~     trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with~     bronchopulmonary dysplasia.~   "
78969|NCT02023775|"~     Prospective, longitudinal, open-label, multicentre, observational, non-comparative national~     study using an exhaustive registry of implantations over a given period.~      This study is requested by French Health Authorities for reimbursement renewal, to maintain~     reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in~     France.~   "
78951|NCT02024009|"~     This study will evaluate the role of increasing radiotherapy dose and addition of nelfinavir~     to chemoradiotherapy (CRT) in patients with inoperable pancreatic cancer that has not spread~     beyond the pancreas.~      Currently in the United Kingdom (UK), either chemotherapy alone or chemotherapy followed by~     CRT can be used in the management of inoperable pancreatic cancer that has not spread. CRT~     consists of 25-30 radiotherapy treatments in combination with chemotherapy. Although this~     treatment is effective in controlling local symptoms and slowing down the pace of cancer, in~     most cases it is unable to shrink it enough to make it operable. Some of the reasons for~     this could be the lack of oxygen and lack of blood flow within the tumour making it~     resistant to the effects of CRT. This study will investigate whether increasing the dose of~     radiotherapy, or increasing the oxygen and blood supply to the tumour by giving nelfinavir,~     or a combination of both, can improve outcomes. We also want to know what the additional~     toxicities from such intensive approaches are.~      All participants will initially receive 12 weeks of chemotherapy, and those with stable or~     responding disease will receive further study treatment. The treatment allocation to 1 of~     the 5 options outlined below will be done at random by computer and neither the doctor nor~     the patient can choose the treatment option. The process of randomisation ensures that all~     treatment arms are equally balanced in terms of patient and tumour characteristics, and to~     reduce the possibility of bias.~      The study will consist of 2 stages. In the 1st stage we aim to find the right dose of~     nelfinavir to combine with CRT, and this will require around 27 participants of whom up to~     18 will receive nelfinavir together with CRT. In the 2nd stage, we want to find out the~     benefits of this approach over and above standard treatments and therefore we will recruit~     the order of 262 participants and allocate 170 to 1 of the 5 following treatment arms:~      Arm A: Nelfinavir together with CRT Arm B: CRT (without nelfinavir) Arm C: Nelfinavir~     together with CRT (but using a higher than conventional dose of radiotherapy) Arm D: CRT~     without nelfinavir (but using a higher than conventional dose of radiotherapy) Arm E:~     Chemotherapy alone (without radiotherapy) Participants who are ineligible or refuse~     randomisation will be treated as per local standard but will remain in the study for follow~     up at 26, 39 and 52 weeks. Their data will contribute to an Overall Survival (OS) analysis.~   "
78952|NCT02023996|"~     This study is divided into two groups. The purpose of the first group (Group 1) was to find~     the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how~     long it stayed in the blood, and to see how well it was tolerated. From what the~     investigators have learned from Group 1, patients in Group 2 no longer need serial scans or~     serial blood draws.~      For Group 2, the patient will receive the injection of 89Zr-DFO-trastuzumab and will be~     monitored following the injection. The patient will be asked to return for a picture 5-8~     days after injection to determine how well the study drug attaches to your tumor and how~     well it is tolerated~   "
78953|NCT02023983|"~     The aim of the study is to prove that early discharge (within 72 hours) in selected group of~     patients after myocardial infarction with elevations of ST-segment is feasible and safe~   "
78954|NCT02023970|"~     Cardiac valve disorders are widely spread in the general population and represents the third~     most frequent cardiovascular illness after coronary disease and arterial hypertension. In~     this context, aortic valve stenosis (the central pathology in this project) is the most~     common form of valve disease. Cardiac valve replacement is in the vast majority of cases the~     first line therapy for degenerative heart-valve diseases. These are represented by~     mechanical and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived~     from animals and from a biological standpoint are classified as xenografts. BHV are severely~     penalised by a premature structural damage, with ultimate valve failure occurring around 10~     years after surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors~     [including dyslipidaemia, gender, valve position] may contribute to the ultimate failure of~     the BHV and there has been increasing evidence recently of a substantial immune reaction~     elicited by the implanted BHV. This immune response is still poorly understood. It may lead~     to adverse immune reactions and this will be thoroughly investigated by the TRANSLINK team.~     In this light, the TRANSLINK project aims to provide the necessary data to demonstrate~     beyond any reasonable doubt the central role of the anti-BHV immune response in the~     premature failure of BHV and to provide efficient strategies to enable safe implantation of~     BHV valves in currently unsuitable candidates~   "
78955|NCT02023957|"~     The current protocol pertains to the evaluation of the interactive computer-assisted~     screening (iCAS) tool through a pilot randomized control trial. The purpose of this~     evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection~     of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic~     stress disorder/alcohol dependence), and patients' discussion on mental health.~   "
78956|NCT02023944|"~     Interventions aimed at disseminating information about cognitive aging and lifestyle factors~     that contribute to successful cognitive aging, in addition to providing broad cognitive~     skills training, may improve the psychological wellness and day-to-day functioning of the~     aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about~     brain aging, lifestyle factors that contribute to successful aging, and techniques that can~     boost cognition in daily life.~   "
78957|NCT02023931|"~     A pilot study has been designed to determine (primary objective) if three brief~     interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway~     signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects.~     Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as~     measured in serial buccal cell scrapings, will be determined during the course of 3-day~     exposures to three BSE regimens. These data will inform the design of a randomized, phase II~     chemoprevention trial in patients with HPV-negative HNSCC.~      Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and~     female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear~     Institute or the Hillman Cancer Center. This may include patients with benign disease or~     their friends/family members, or friends/family members of patients with cancer; 2)~     Professionals, staff, or students at the University of Pittsburgh.~   "
78958|NCT02023918|"~     Growth hormone is well known to cause changes in glucose regulation. People with Laron~     syndrome are born without the growth hormone receptor and are protected from diabetes. Mice~     who are engineered without the growth hormone receptor are similarly protected from~     diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients~     with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients,~     treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by~     blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant~     has not been explored as a possibility for the treatment of type 2 diabetes or insulin~     resistance in people without acromegaly. In this study, the investigators hope to study the~     metabolic effects of pegvisomant on people who have insulin resistance but not diabetes.~     Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well~     as decrease serum free fatty acids.~   "
78979|NCT02023645|"~     Past research suggests that retinal lutein levels are related to cognitive function as~     measured via behavioral tests. The goal of the present study is to investigate the~     relationship between lutein and cognitive function in a wider variety of the population~     (young, healthy adults and older adults), using a wider variety of methods (behavioral~     testing and neuroimaging).~   "
78959|NCT02023905|"~     The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001,~     also known as Afinitor®) alone or with temozolomide has on the patient and the patient's~     low-grade glioma. Everolimus is being investigated as an anticancer agent based on its~     potential to prevent tumor cells from growing and multiplying. Specifically, there is a~     protein called mTOR that we think helps many tumors to grow, and everolimus blocks the~     effect of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from~     growing and multiplying. About 159 people total will take part in this study. Patients will~     be assigned to one of three treatment groups depending on the results of some tests done on~     their tumor. Each group will have 53 patients in it. 2 groups will receive treatment with~     everolimus alone, while the third group will receive treatment with both everolimus and~     temozolomide. In this study, patients will be assigned to one of 3 treatment arms based on~     two characteristics of their tumor, called 1p/19q (this is a test of the tumor~     chromosomes) and p-PRAS40 (this is a test of a pathway in the tumor called mTOR). If the~     patient's tumor is 1p/19q intact and p-PRAS40 positive, the patient will be assigned to~     Treatment Arm 1, and the patient will receive everolimus alone. If the patient's tumor is~     1p/19q intact and p-PRAS40 negative, the patient will be assigned to Treatment Arm 2 and the~     patient will receive everolimus and temozolomide. If the patient's tumor is 1p/19q~     co-deleted, regardless of the p-PRAS40 result, the patient will be assigned to Treatment Arm~     3, and the patient will receive everolimus alone.~   "
78960|NCT02023892|"~     Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating~     endothelial microparticles and flow-mediated vasodilation in the brachial artery by~     ultrasound at different time points.~   "
78961|NCT02023879|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with~     placebo in patients with primary hypercholesterolemia not treated with a statin.~      Secondary Objective:~      To evaluate the safety and tolerability of alirocumab.~   "
78962|NCT02023866|"~     Patients with mitochondrial diseases, who are ≥ 2 years old and < 18 years, will be included~     in this study. It is anticipated that approximately one half of subjects will have~     genetically confirmed Leigh Syndrome. Up to 25 patients will be enrolled if there is no~     toxicity up to the level of 1.3 g/m2/day of RP103. Interim analyses will occur after 4 and~     then 12 subjects complete the study through Week 24. If the study is not stopped early,~     final analysis will occur after 25 subjects have completed through Week 24.~   "
78963|NCT02023853|"~     20 consecutive adult implant patients, presenting the signs of peri-implant mucositis~     (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial~     peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of~     supporting bone ≤30% compared with the situation after implant placement) will be included.~      Sites will be treated by ultrasonic debridement of the pocket, performed using a~     piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece~     Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol~     powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At~     this time the subgingival delivery of metronidazole gel will be provided. After~     instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.~      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:~     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).~   "
78964|NCT02023840|"~     Aim of the present study is evaluate the use of erythritol powder with/without the adjunct~     of local metronidazole in the treatment of periodontal pockets.~      20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of~     their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be~     enrolled. For each patients four sites will be considered for the study, and two sites will~     be allocated in the test group and two sites will be allocated in the control group. In the~     test group, ultrasonic debridement of the pocket will be performed using a piezoceramic~     ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it~     will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this~     time the subgingival delivery of metronidazole gel will be provided. In the control group,~     the same protocol will be used except for the use of a placebo instead of metronidazole.~     After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.~      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:~     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).~   "
78965|NCT02023827|"~     Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders~     themselves. However, research assessing the efficacy of interventions for young offenders~     show, on average, only small effects on recidivism, substance abuse, and other behavioral~     outcomes. A major problem with existing interventions is that they tend to neglect~     individual differences in motivation and readiness to make positive changes. In earlier~     research, we used an empirically validated model of behavior change, the Transtheoretical~     Model (TTM, the stage model), and expert system technology to develop the Rise Above Your~     Situation program (RAYS), a prototype of a multimedia computerized tailored intervention~     designed as an adjunct to traditional juvenile justice programs. The intervention delivers~     assessments and individualized feedback matched to readiness to stay out of trouble with the~     law and quit alcohol and drugs. At the end each session the program also generates a~     helpgiver report that summarizes the youth's feedback and presents concrete,~     easy-to-implement strategies helpgivers can use to reinforce stage-matched concepts. In the~     current research, the goals are to complete development of the computerized tailored~     intervention; develop training and other support materials for helpgivers; and assess the~     efficacy of the intervention package in a randomized clinical trial involving 700 medium- to~     high-risk court-involved juveniles aged 13-17 recruited by 54 probation officers randomly~     assigned to treatment or standard care. Primary outcomes will be criminal recidivism and~     substance abuse abstinence at 6 and 12 months follow-up.~   "
78966|NCT02023814|"~     Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution~     between 2002 and 2013 were reviewed in order to define prognostic factors for optimal~     harvest~   "
81533|NCT01990222|"~     The goal of this study is to develop and test a mobile web application to optimize early~     stimulant medication treatment for children receiving care for Attention/Deficit~     Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.~   "
78970|NCT02023762|"~     Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a~     therapeutic alternative to surgical valve repair in patients who are at high risk and~     unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia,~     but the MitraClip® is also feasible in deep sedation.~      The aim of this study is to investigate the safety of deep sedation in patients undergoing~     the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia~     influences procedural time and in-hospital stay.~   "
78971|NCT02023749|"~     This study aimed to investigate the effects of nut consumption on metabolic parameters and~     biomarkers related to inflammation, oxidative stress, and endothelial function in Korean~     adults with metabolic syndrome.~   "
78972|NCT02023736|"~     This study is a comparison of client outcomes in two different types of psychotherapy~     treatment. In one condition clients will receive treatment-as-usual (TAU); the therapy that~     they would normally receive. In the other condition clients will receive treatment-as-usual~     but in addition their therapist will have access to empirical feedback on client progress.~     Clients in the feedback condition will fill out weekly online questionnaires, and their~     therapists will have access to a website that feeds back the results of these~     questionnaires. The purpose of the study is to understand the impact of providing such~     feedback to therapists. Participating therapists at 4 sites will offer all of their clients~     the opportunity to participate, and participating clients will be randomly assigned to~     either condition. This should result in a representative sample of client seeking treatment~     at these 4 Chicago-area clinics.~   "
78973|NCT02023723|"~     This study is designed as a safety assessment to determine the cardiac and hemodynamic~     effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and~     blood pressure measurements. It will evaluate the use of a consumer available product that~     is classified as a dietary supplement by the FDA.~   "
78974|NCT02023710|"~     Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment~     for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study~     in patients with previously untreated metastatic mucosal melanoma to characterize the~     efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.~   "
78975|NCT02023697|"~     This study will assess different doses and regimens of radium-223 dichloride on the~     incidence of symptomatic skeletal events. Eligible subjects must have castration resistant~     prostate cancer with 2 or more skeletal metastases documented within 8 weeks of~     randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a~     standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of~     NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88~     kBq/kg after implementation of NIST update)injections every month for 6 months or an~     extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update)~     injections every month for 12 months. Following the treatment phase, subjects will be~     followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long~     term follow-up period during which they are seen every 6 months for up to 7 years after the~     last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be~     assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks~     through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and~     pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16,~     and 24 and continue every 12 weeks thereafter until disease progression is documented in~     either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central~     review.~   "
78976|NCT02023684|"~     The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at~     the surgical bed on postoperative pain relief and breathing parameters in laparoscopic~     sleeve gastrectomy.~   "
78977|NCT02023671|"~     The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the~     collection of a series composed of patients with multiple myeloma undergoing allogeneic stem~     cell transplants at our center in the period 2000-2011.~      This collection is carried out with retrospective investigation , through the review of~     paper and electronic records and data cards already collected as part of clinical trials~     conducted by our own Division and approved by the Ethics Committee of Management.~      The purpose of data collection is particularly retrospective analysis of the incidence of~     extramedullary relapse , the response in flow cytometry immunophenotypic and clinical~     response of the disease , will also be taken into consideration for overall survival ( OS) ,~     event-free survival (EFS) , the cumulative incidence of treatment-related mortality and~     graft- versus-host disease ( GVHD ), acute and chronic.~      The data were processed in a completely anonymous and as provided by law. The results of the~     study will not result in any diagnostic or therapeutic intervention on patients still alive.~   "
78978|NCT02023658|"~     Despite significant increases in global health investment and the availability of low-cost,~     efficacious interventions designed to reduce mother to child HIV transmission in low and~     middle income countries with high HIV burden, the translation of these scientific advances~     into effective delivery strategies has been slow, uneven and incomplete. As a result,~     pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT~     interventions through contextually appropriate systems analysis and improvement approaches~     can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements~     in infant and maternal outcomes. The goal of this proposal is to develop a model for~     systematic assessment and improvement of pMTCT services in sub-Saharan Africa. In specific~     aim 1, we will identify health system factors and service delivery approaches associated~     with high and low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In~     specific aim 2 we will adapt evaluate the feasibility and impact of a systems analysis tool~     and associated performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya~     and Mozambique. This systems analysis tool and associated performance enhancement approach~     is currently being developed and piloted for pMTCT services in Mozambique. The results of~     this implementation research are expected to generate knowledge of global health~     significance, and by disseminating the study results and intervention tools through the~     broad PEPFAR network, can rapidly impact pMTCT service delivery enhancements across the~     highest need countries.~   "
80292|NCT02006472|"~     This is a multicenter, multinational, randomized, parallel-group, double-blind,~     placebo-controlled, does range finding study to compare the efficacy and safety of different~     doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's~     Disease (HD).~   "
78980|NCT02023632|"~     Regular physical activity is associated with a diverse range of physical and mental health~     outcomes, with the effects being particularly pronounced among older adults. Despite these~     health benefits, involvement in physical activity has been found to decline over the course~     of adulthood with older adults in particular risk of inactivity. A growing body of evidence,~     however, suggests that group-based settings that are sensitive to both the age-composition~     and gender-composition of their constituent members may represent an opportune means of~     supporting the improved adoption and maintenance of older adults in physical activity~     programs. The overall purpose of this feasibility trial is to test the effectiveness of a~     group-based physical activity program for older adults that is sensitive to both~     age-congruent and gender-congruent contextual factors, in supporting their sustained~     involvement in physical activity.~   "
78981|NCT02023619|"~     The purpose of the study was to identify corneal epithelial- and stromal-thickness~     distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography~     (SD-OCT).~      Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal~     epithelial and stromal thicknesses for identification of a pattern characteristic for early~     keratoconus.~   "
78982|NCT02023606|"~     An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and~     Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers~   "
78983|NCT02023593|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as~     second-line treatment for metastatic esophageal carcinoma.~   "
78984|NCT02023580|"~     Although HIV testing and highly effective antiretroviral therapy (ART) have improved~     survival with HIV, the relatively low level of ART adherence presents a significant public~     health challenge in terms of the potential to transmit HIV. Preventing transmission in~     virally unsuppressed HIV+ MSM who have unprotected anal intercourse (UAI) with~     serodiscordant partners can have a great public health impact. As new HIV infections in MSM~     have been attributed in part to increased access to sex partners online, it is critical to~     deliver behavioral interventions to HIV+ MSM online to reach many high-risk men at a~     relatively low cost.~      The investigators' theoretically-grounded HIV prevention videos about UAI, HIV disclosure,~     and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated~     significant reductions in UAI and significant increases in HIV status disclosure at 3-month~     follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT)~     for MSM, investigators found significant reductions in UAI among MSM in the video arm at~     60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including~     serodiscordant UAI (SDUAI) at 60-day follow-up, compared to baseline. Based on these~     findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals,~     to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The~     investigators have identified a potentially highly effective and feasible risk reduction~     intervention approach for HIV+ MSM.~      With the commitment of POZ and a strong team of experts, the investigators propose to refine~     our intervention by editing our 3 HIV prevention videos into short doses for 10 online~     sessions (including boosters); targeting HIV+ MSM who are virally unsuppressed; monitoring~     self-reported clinical indicators (i.e., viral load); targeting online recruitment by~     race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM for balanced~     representation; improving retention with incentives and a proven online platform; including~     educational information about ART adherence; and cost and cost-effectiveness analyses for~     potentially averted HIV infections to determine health-related cost savings. Online, the~     investigators will recruit and follow a national sample of 1,500 high-risk, virally~     unsuppressed HIV+ MSM for 12 months.~   "
78985|NCT02023567|"~     Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high~     recurrence rate, suicide rate and disability rate. It's reported that the global burden~     caused by MDD will be up to the second rank among all the disease burdens by 2020. China is~     also confronted with the daunting challenges against MDD. It's assessed that the monthly~     incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment~     rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the~     current therapies don't work well. Therefore, it's urgent and critical to elucidate the~     pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD.~     Considering the diversity of weights on genetic factor and environmental factor in MDD, in~     this project, the investigators aim firstly to explore the effect of genetic-environmental~     interactionon the pathogeny of MDD for classifying MDD into genetic type, environmental~     type and others based on a case-control study. We next conduct the neurobiological,~     neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups~     to screen the salient endophenotypes for establishing the diagnostic models of MDD . The~     investigators further analyse the changes of these indicators after 8 weeks'medication to~     select the potential predictors for therapeutic evaluations and interventional options in~     MDD patients. Finally, the investigators continue a 2-year follow-up study to test and~     verify the predictors of prognosis in MDD patients.~   "
78986|NCT02023554|"~     Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere~     with the pharmacokinetics of many other drugs that are metabolised by this enzyme like~     theophylline.The aim of this study is to determine whether azithromycin can effect~     theophylline metabolism in patients.~   "
78987|NCT02023541|"~     Assess progression-free survival and overall survival of proton beam therapy (PBT) for~     patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported~     outcomes of PBT for esophageal cancer at 6 months following chemoradiation and~     physician-reported toxicity of PBT for esophageal cancer.~   "
78988|NCT02023528|"~     Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is~     lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of~     dialysis patients is ~ 23% compared to <0.1% in the United States general population. Even~     kidney transplant recipients have a substantially higher mortality (~7%) compared to the~     general population. Consequently, the life-expectancy of dialysis and transplant populations~     is much lower than that of the general population. Cardiovascular events are the leading~     cause of death in dialysis patients and malnutrition is also a strong risk factor for death.~     The current proposal is to develop a prospective registry of incident dialysis patients at~     the University of Utah dialysis program to examine cardiovascular and nutritional factors in~     dialysis patients. This registry will include clinical and administrative data. In addition,~     blood samples will be stored for future analyses.~   "
78989|NCT02023515|"~     The purpose of this study is to learn the impact stress may have on weight management and~     emotional eating.~   "
79237|NCT02020265|"~     EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols,~     Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be~     more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while~     in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our~     newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference~     between the groups in regard to their emotion regulation capability will be tested by fMRI~     with regard to amygdala activation following EEG-NF LMI as well as two stress challenge~     tests.~   "
78990|NCT02023502|"~     Objective: The primary objective of the study is the comparison of protein concentrations~     between patients with stress urinary incontinence (SUI) and healthy controls.~      Aim: This pilot study aims to determine a possible altered protein profile in women~     suffering from SUI, compared to healthy women and therefore to discriminate a potential~     protein biomarker for SUI.~      Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in~     diseased and healthy subjects (sequence coverage and number of identified proteins)~      Trial design: Prospective case- control study~      Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co-~     operation with the Core Facilities Proteomics of the Medical University of Vienna~      Population: Twenty female patients with SUI and twenty healthy patients who attend the~     outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of~     Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95,~     assumed standardized effect size of 1)~      Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ~     short form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick~     testing). A urine sample is obtained from the patient after spontaneous micturition, to~     which protease inhibitor will be added immediately. Two serum blood vials (each 9ml) are~     taken from a peripheral vein of the patient for routine laboratory and further research.~      Proteomics analysis will be performed using chromatographic separation (LC) with mass~     spectrometric detection (MS).~   "
78991|NCT02023489|"~     Background:~      Type 2 diabetes mellitus is a main risk factor for cardiovascular disease and heart failure,~     in part due to diabetic cardiomyopathy. However, the association between intracellular lipid~     accumulation and (myocardial) functional impairment is likely more complex than originally~     imagined. Recent studies suggest that not fat per se, but the content of saturated or~     unsaturated fatty acids might predict the development of cardiac steatosis and myocardial~     dysfunction.~      In addition skeletal muscle and hepatic glycogen metabolism is impaired in patients with~     diabetes mellitus. Data from animal experiments suggest a relevant role of myocardial~     glycogen stores in ischemic preconditioning. Due to methodological limitations so far data~     on myocardial glycogen stores and myocardial lipid composition in humans are missing.~      Hypothesis:~      In addition to total ectopic lipid deposition in the myocardium, myocardial lipid~     composition, i.e. the relative abundance of saturated and unsaturated fatty acids, and~     impaired myocardial glycogen metabolism may play an important role in the development~     cardiac lipotoxicity leading to diabetic cardiomyopathy.~      Pancreatic endocrine function and myocardial morphology and function is altered in patients~     with heterozygote inactivating mutations of the CaSR-gene / FHH.~      Aims:~        -  Metabolic virtual biopsy of the myocardium for identification of specific patterns of~          intracellular lipid composition and myocardial glycogen metabolism as possible critical~          determinants of metabolic cardiomyopathy~        -  Characterization of the metabolic interplay between the myocardium, skeletal muscle,~          liver and adipose tissues in different stages of development of type 2 diabetes~          compared to patients with calcium sensing receptor mutation~      Methods:~        -  1H/13C and 31P magnetic resonance spectroscopy and imaging for measurements of~          myocardial, skeletal and liver lipid and glycogen content, abdominal adipose tissue~          distribution and composition, ATP synthesis and myocardial functional parameters~        -  Mixed meal tolerance tests to trace the postprandial partitioning of substrates between~          insulin sensitive tissues (myocardium, skeletal muscle, liver, adipose tissue).~        -  Hyperinsulinemic-hyperglycemic glucose clamp (HHC) with enrichment of the infused~          glucose with the stable isotope [1-13C]glucose to trace the incorporation of~          circulating glucose into myocardial glycogen~      in healthy insulin sensitive volunteers, prediabetic insulin resistant volunteers with~     impaired glucose tolerance, healthy subjects, patients suffering from type 2 diabetes~     mellitus, patients suffering from type 1 diabetes and patients with heterozygote mutation in~     calcium sensing receptor.~   "
78992|NCT02023476|"~     Nerve injury is a serious potential complication associated with the clinical use of~     exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been~     proposed, with the claim that it may cause less compression of the nerves. We performed an~     in vivo comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study~     specifically looked at neurologic markers in the upper extremity.~   "
78993|NCT02023463|"~     This phase I trial studies the side effects and best way to give enzalutamide, radiation~     therapy, and hormone therapy in treating patients with intermediate or high-risk prostate~     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses~     high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone~     therapy may be an effective treatment for prostate cancer.~   "
78994|NCT02023450|"~     Study Rationale:There is recent evidence that HIV protease inhibitors (HIV-PI) can improve~     pulmonary hemodynamics in experimental models of pulmonary arterial hypertension (PAH).~     There is also experimental evidence that both TLR4 and high mobility group box 1 (HMGB1)~     participate in the pathogenesis of experimental pulmonary hypertension. A recent high~     throughput screen for inhibitors of HMGB1 induced macrophage activation yielded HIV-protease~     inhibitors (PIs) as potent inhibitors of HMGB1 induced cytokine production. Based on the~     experimental evidence we propose a trial to determine whether HIV-PIs will alter the~     pathobiology of PAH.~      Study Objectives:The main objective of this study is to determine whether saquinavir and~     ritonavir (SQV+RIT) which have a well-characterized safety profile in humans will reduce bio~     markers of inflammation and pulmonary artery pressures in patients with PAH.~      Study Hypothesis:We hypothesize that the HIV-PI, SQV+RIT, will reduce circulating parameters~     of inflammation including HMGB1, IL1-beta, IL-6, IL-8, IL-10, TNF-alpha and CRP. Our end~     points will be changes in these parameters from baseline over the duration of the study.We~     hypothesize that treatment with SQV+RIT will reduce pulmonary artery(PA) pressure of~     patients with PAH as measured by echocardiography.~      Study Design:This is a single center open label phase 0 study to evaluate the effect of SQV~     +RIT in patients with IPAH. Subjects with IPAH(N=20) will be enrolled into a study, which~     will be divided into 3 cohorts and entail the administration of HIV protease inhibitors in~     three doses. The first cohort (n=3) will receive a starting dose of SQV 0.3 mg/kg twice~     daily in combination with RIT 0.03 mg/kg twice daily. If the first dose is well-tolerated,~     the second cohort (n= 3 ) with IPAH will be given doses of SQV 3 mg/kg and RIT 0.3 mg/kg~     twice daily. If the second dose is well-tolerated, the last cohort (n= 14 ) with IPAH will~     be given doses of SQV 15 mg/kg and RIT 1.5 mg/kg twice daily.~   "
78995|NCT02023437|"~     This clinical study is a prospective, post-market-clinical-follow-up study to investigate~     the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study~     follow-up extension to the Study #1304 titled as A Multi-centre, Multi-surgeon, Randomized,~     Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of~     Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation~     Procedure.~   "
79007|NCT02023281|"~     The purpose of this study is to examine the effects of exercise on the symptoms of~     depression using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and~     self-report of symptoms as markers.~      In an attempt to further understand the mechanisms of improved mood through exercise; this~     study will examine the known factors that contribute to depressed mood in a single study~     using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such~     information can be useful in understanding the overall neurological components of depression~     and the effects of exercise on the brain in depressed individuals that would make the~     prescription of exercise a viable treatment option.~   "
79008|NCT02023268|"~     Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to~     severe Dry Eye Syndrome~   "
79009|NCT02023255|"~     The purpose of the study is to evaluate the safety and tolerability of multiple dose~     administration of JNJ-39393406 in young healthy participants, and subsequently in healthy~     elderly participants.~   "
79010|NCT02023242|"~     This clinical trial compares two implantable devices intended to lower the pressure inside~     the eye of glaucoma patients.~   "
78996|NCT02023424|"~     Primary Objective: To test the hypothesis that 6 months treatment with glatiramer acetate~     (GA) decreases epileptiform activity in young girls with Rett syndrome.~      Primary Safety Objective:To evaluate the safety and tolerability of 6 months treatment with~     GA in these patients.~      Secondary Objectives:~        1. To test the hypothesis that 6 months treatment with glatiramer acetate (GA) improves~          respiratory dysfunction.~        2. To evaluate the effect of GA treatment on general behaviour communication, hand~          stereotyping, feeding, sleep and other autonomic symptoms: gastrointestinal and~          cardiac.~        3. To assess the effect of GA treatment on bodily development.~      Primary Endpoint:Improvement of epileptiform activity as recorded in a 24-hours EEG.~      Primary Safety Endpoint:Frequency and severity of treatment-related AEs (including safety~     lab parameters).~      Secondary Endpoints:~        1. Improvement in the scoring of breath holds and hyperventilation, as measured with~          non-invasive respiratory inductance plethysmography (NoxT3 device) and parents'~          diaries.~        2. Changes in general behaviour, communication, feeding and motor skills as assessed by~          the investigator (based on Kerr and Naidu validated severity scores) and recorded in~          parents' diary.~        3. Decrease in seizure frequency as reported in parents' diary.~        4. Improvement in sleep schedule as recorded in a sleep diary.~        5. Change in height and weight. Population:Ten girls, 6 to 15 years old, diagnosed with~          Rett syndrome (RTT) Study Design:This is a single - center, exploratory, open-label,~          study in 10 girls diagnosed with RTT. The study will consist of four parts: Screening~          and baseline assessments, initial and final dose-setting period, treatment period and~          end-of study follow-up.~      Investigational Product:Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.)~     Sample Size Consideration: The planned sample size of 10 patients was considered adequate by~     the investigator for this phase I exploratory proof-of-concept study. The study is not~     expected to show statistical significance or statistical power, only a trend for the study~     endpoints. Each patient will serve as her own control.~      Duration of Study: Approximately 8 months per patient (including up to 2 weeks pre-treatment~     assessment, 6 months initial dose and treatment periods and end-of study visit).~      Overall study duration: the study is expected to be completed within 12 months (dependent on~     rate of recruitment).~   "
78997|NCT02023411|"~     Diabetic foot represents a major medical , social and economic problem worldwide.~      Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing~     topic of research for endocrinologists, podiatrists and surgeons. After its first~     description by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding~     its pathophysiology , but not much research has been done for its prevention and treatment ,~     specially the inactive stage.~      The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually~     missed in the active stage, henceforth the patients often come to us with a deformed foot.~     As a consequence , the osteoclastic activity in active stage renders the foot bones~     demineralized and weak, thus being susceptible to fracture and fragmentation.~      Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for~     post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by~     preferentially stimulating osteoblast over osteoclast activity resulting in new bone~     formation and an increase in the rate of bone remodeling which manifest as an increase in~     skeletal mass and bone mineral density .~      Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential~     treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized~     trials in this setting, till date. We hypothesize that teriparatide may increase the~     remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density,~     subsequently leading to a reduction in the risk of fractures and progression of deformities.~     This study plans to compare the effects of teriparatide in diabetes patients with inactive~     Charcot's foot in a placebo controlled design.~   "
78998|NCT02023398|"~     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving~     3 cm or greater average waist circumferential reduction in HFT group of subjects relative to~     the base line and 1 cm or greater reduction relative to the average waist circumferential~     reduction of the Placebo group.~   "
78999|NCT02023385|"~     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in~     achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects~     relative to the base line and 1 cm or greater reduction relative to the average waist~     circumferential reduction of the Placebo group.~   "
79000|NCT02023372|"~     The purpose of this study is to determine whether NuCel is effective in promoting spinal~     fusion in degenerative disease of the lumbar spine.~   "
79001|NCT02023359|"~     An observational study in patients with advanced ER+, HER2 negative breast cancer, who are~     treated with everolimus and exemestane in combination. The objective of the study is to~     assess the safety pattern of everolimus in a real world setting.~   "
79002|NCT02023346|"~     The purpose of this study is to learn more about the understanding patients with brain~     tumors have of their disease and their communication with their physician. Ultimately, we~     hope to use these findings to improve communication between patients and their doctors.~   "
79003|NCT02023333|"~     The purpose of this study is to evaluate the good and bad effects when regorafenib is used~     instead of standard combination chemotherapy. It is not known if taking regorafenib versus~     standard chemotherapy will have better, worse or the same results.~   "
79004|NCT02023320|"~     The purpose of the present study is to evaluate the effect of blueberry dry powder on~     glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose~     tolerance test (OGTT), or HbA1c) in subjects with prediabetes.~   "
79005|NCT02023307|"~     This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when~     using a short flap, short incision technique in during a traditional face-lift. The~     objective of this study is to assess the suture's potential in elevating the mid-face when a~     traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will~     elevate the mid-face more effectively when using a short flap, short incision technique on a~     traditional facelift.~   "
79006|NCT02023294|"~     Bariatric surgery has been established as the best treatment for morbid obesity, compared~     with diet or medical treatment. Laparoscopic approach have improved the results of this~     surgery in terms of postoperative pain, reduction in the number of complications and~     hospital stay, as well as better cosmetic results. Conventional laparoscopic technique~     requires five to seven abdominal incisions to facilitate placement of the multiple trocars.~     New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where~     only one incision is needed for the introduction of all trocars. Altough this technique can~     be performed with conventional laparoscopic instruments, new devides have been developed for~     facilitate this operations by SILS. The investigators think that reducing the number of~     incision would decrease the postoperative pain and improve cosmetic results in our patients,~     being a safe and technically feasible intervention supported by these special devices.~   "
79011|NCT02023229|"~     Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have~     decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory~     cytokines.~      We hypothesized that branched chain aminoacids can improve nutritional status and delay~     episodes of hepatic encephalopathy~   "
79012|NCT02023216|"~     Gastro-esophageal reflux (GER) is a common condition among preterm infants, due to several~     physiological promoting factors. To limit the potentially harmful widespread of~     pharmacological treatment, a step-wise approach, which firstly applies conservative~     strategies, is currently considered the best choice to manage GER in the preterm population.~     Among the most common conservative strategies, postural measures seem to represent an~     effective measure to reduce GER features in symptomatic preterm babies, whereas feed~     thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely~     applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both~     reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs),~     thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate.~     Hence, a possible effect of NNS on GER features might be hypothesized.~      This observational, prospective and explorative study primarily aims to explore the effect~     of NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in~     symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH~     and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to~     evaluate, in the subgroup of patients with recurrent GER-related apneas, the effect of NNS~     on cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed~     apneas and detected by a simultaneous polysomnographic monitoring.~   "
79013|NCT02023203|"~     Inguinal hernia repair is one of the most commonly performed surgeries around the world. It~     accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of~     27% in males and 3% in females. Since the modern concept of surgical hernia repair described~     by Bassini in 1887, with the technique that bears his name, several techniques have been~     developed in the last century in order to improve surgical outcomes after inguinal hernia~     repair.~      Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach~     were described and developed, until Lichtenstein described the tension-free hernioplasty~     concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable~     Improvements were observed with this technique in terms of recurrence, pain, and discomfort~     in comparison with previous tension repairs. Considerable advantages over open repair have~     been obtained with the introduction of minimally invasive surgery to inguinal hernia repair,~     in terms of patient comfort and recurrence rates.~      Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by~     Lichtenstein. First generation meshes were manufactured using more material and for this~     reason they have been described as heavyweight meshes. New generation meshes have been~     designed with less material in order to diminish the inflammatory response and foreign body~     reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes.~     The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size~     of the pore and lately it has been reported that one of the main aspects related to~     prosthetic materials is pore size. Large pore meshes use less material, consequently they~     have been associated with a better tissue ingrowth. The large pore of lightweight meshes is~     conditioned by the less amount of material used.~      All previous studies compare both light and heavyweight polypropylene meshes But in order to~     get a proper comparison of the behavior of meshes in the inguinal region it is important to~     include the material and the pore size. The aim of our study is to compare patient-reported~     outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE)~     vs a small pore polypropylene mesh (SP-PPL).~   "
79014|NCT02023190|"~     Liver transplant is the goal treatment for every patient with end-stage chronic liver~     disease.~      Quality of life improves after transplant because the main complications of end-stage liver~     disease disappear, but due to immunosuppression other alterations appear such as metabolic~     alterations, weight gain, among others.~      Body composition and nutritional status can be affected do to post-transplant pharmacologic~     therapy.~   "
79015|NCT02023177|"~     A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they~     have proven to be useful in prognosticating severity of the disease and mortality. However,~     PhA needs specific validation in different ethnic groups. The aim of this study was to~     evaluate the PhA cut-off value that would best define malnutrition and predict mortality in~     patients with liver cirrhosis.~   "
79016|NCT02023164|"~     This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical~     study of JDP-205 injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic~     equivalent), in approximately 36 patients with acute urticaria requiring treatment in~     Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.~   "
79017|NCT02023151|"~     This research is being done to test whether differences in blood cells at baseline (start of~     the study) can be used to predict how well omalizumab will work in a patient. Omalizumab~     (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma.~     Studies show that omalizumab improves the symptoms of asthma but some people experience~     better improvement than others.~   "
79018|NCT02023138|"~     There is a lack of evidence about the best method to involve the patient and population~     (IPP) into clinical practice guidelines (CPG) development. The goal of this pilot study is~     to document the acceptability, feasibility and effectiveness of two methods for the~     implication of patients with a traumatic brain injury (TBI) in CPG development. Method: A~     single blind, randomized crossover trial will be performed with patients having a TBI.~     Participants: A convenience sample of 20 patients a) with a moderate-to-severe TBI (Glascow~     Coma Scale <13), b) living with a TBI for two to four years, c) French-speaking, d) able to~     use a computer and e) able to participate in a two-hour group meeting will be recruited~     among the members of the Associations TCC Des Deux Rives. Procedures: The patients will~     first receive a in-person training on guidelines and IPP. They will be randomized into Group~     1 or Group 2 by a researcher blinded to experimentation. They will experiment either group~     discussion (control intervention) or a Wiki (experimental intervention). Phase 1: A week~     after the training, Group 1 participants will be invited to a discussion group animated by~     an experimented moderator, where they will be asked to discuss a CPG recommendation chosen~     by the research team in an existing CPG. The participants will be asked : 1) about their~     opinion of the recommendation; 2) if they have a preference in regard to the recommendation~     ; 3) if they have some modification, correction or addition to bring to this recommendation.~     In the mean time, Group 2 participants will receive an email presenting a link to a Wiki.~     They will be invited to answer the same three questions as Group 1, but using a Wiki~     platform. The patients will have a week to interact and answer the questions; recalls could~     be sent by email if required. At the end of Phase 1, participants of both groups will fill a~     questionnaire documenting the acceptability of the method experimented. Phase 2: As per the~     crossover design, the Group 1 participants will then be assigned to the Wiki intervention~     and the Group 2 participants will be assigned to the discussion group intervention. The~     procedure will be repeated with a second recommendation. At the end of Phase 2, the patients~     will be asked to answer a short survey to validate their preferences about the two methods.~     Tools: The acceptability of the methods will be evaluated with a questionnaire adapted from~     Sidani and al. and validated with three TBI individuals. The feasibility of the intervention~     will be evaluated using a) the number of participants who reached the group or the Wiki, b)~     the number of participants who completed the intervention c) the number of support~     interventions required in the group and in the Wiki. The effectiveness of the two methods~     will be evaluated by submitting the adapted recommendations to a panel of expert clinicians~     evaluators blinded to the methodologies of recommendations adaptation. They will be invited~     to rate the clarity, accuracy, appropriateness and usefulness of the recommendations.~     Analysis: Feasibility indicators will be reported using descriptive statistics.~     Within-subject analysis using non-parametric statistics will be performed to assess the~     acceptability of the two methods. AC1 coefficient of raters' agreement will be calculated on~     the expert evaluation scores, and the effectiveness of the methods will be compared using~     appropriate non parametric statistics to. Impact: This pilot trial will be the first one to~     evaluate methodologies for involving disabled individuals into CPG development.~   "
79019|NCT02023125|"~     This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group~     2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers.~      Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or~     BA) in which they will receive a single, oral dose of alectinib per period separated by at~     least 10 days. Each participant will receive single, oral doses alectinib given under fasted~     conditions (Treatment A) or following the ingestion of a high fat, high calorie meal~     (Treatment B) as determined by their assigned sequence.~      Participants in Group 2 will be given a single, oral dose of alectinib following a standard~     meal. After a washout period of at least 10 days, they will receive an oral dose of~     esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a~     single, oral dose alectinib will be given after ingestion of a standard meal.~      In all groups, pharmacokinetics will be assessed in the 4 days following alectinib~     administration.~   "
79020|NCT02023112|"~     This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and~     cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of~     ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic~     HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects~     with and without compensated cirrhosis.~   "
79021|NCT02023099|"~     This is a phase 3, double-blinded, multicenter study. The study will consist of 2~     substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and~     Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.~   "
79076|NCT02022384|"~     In this explorative study immunological changes during tumor therapy will be analyzed in~     patients with malignant glioma. Immunophenotyping before and during therapy is used as~     analysis method. Thereby immune cells are quantitatively and qualitatively detected from~     patient's blood at continuous time points. Additionally relevant mediators like cytokines,~     danger signals and chemokines are analyzed by other methods. Obtained results may give~     information about the effects of therapy on immunological processes and immune cells and may~     help to find immunological based predictive or prognostic tumor markers and to define time~     points for including additional immune therapy in the future.~   "
79022|NCT02023086|"~     This study aims to evaluate blood oxygenation at the optic nerve head in relation with~     visual field losses observed in many Fabry patients. Data collected will allow to evaluate~     if there is a link between these two entities.~      Study will last up to 2 years during which a limited number of Fabry patients will be~     compared to a control group to confirm any relationship between blood flow and field losses,~     and to see if these results vary over time.~      HYPOTHESIS~      1. Fabry patients will present significant differences in visual fields compared to control~     2 There will be variability of the visual field defects on the long term but not on the~     short term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic~     nerve head will be the same for both groups.~   "
79023|NCT02023073|"~     The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in~     particular, increased significantly. Making retinal surgery using lasers have become~     increasingly common. The goal: to diagnose eye diseases safely~   "
79024|NCT02023060|"~     The objective is to observe trends in patient characteristics and outcomes after aortic or~     mitral transcatheter heart valve replacement over time.~   "
79025|NCT02023047|"~     This is an open label study. The study will consist of 2 treatment group: coated Nifedipine~     suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated~     Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2).~     Approximately 30 subjects will participate into this 8-week study. The primary objective is~     to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and~     healing.~   "
79026|NCT02023034|"~     Introduction: Although the motor changes are well determined in Parkinson's disease (PD),~     few studies describe the effects the virtual exercises on the clinical and functional~     outcomes in this disease.~      Objectives: To analyze the effectiveness of virtual exercises on functional exercise~     capacity, fatigue and quality of life in patients with PD.~      Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups:~     group of virtual exercises associated with conventional exercises (n = 10) and control group~     with conventional exercise group (n = 10).~      The following variables are evaluated: functional exercise through walking test in 6~     minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life~     Questionnaire-PDQ-39.~   "
79027|NCT02023021|"~     Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than~     5%. About 25% of patients have the opportunity for radically surgical resection when~     diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical~     trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and~     enhanced overall survival for patients who have undergone surgery to remove their tumor.~     Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies~     showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival~     and overall survival of metastatic pancreatic cancer patients. The present study is intended~     to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel~     as adjuvant chemotherapy in treating patients with pancreatic cancer after curative~     resection.~   "
79028|NCT02023008|"~     This pilot clinical trial studies interactive gentle yoga in improving quality of life in~     patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle~     yoga may improve the quality of life in patients with breast cancer undergoing radiation~     therapy.~   "
79029|NCT02022995|"~     Protein arginine methylation is an important process, which regulates diverse cellular~     functions including cell proliferation, RNA stability, DNA repair and gene transcription.~     Based on literature search, protein arginine methyltransferase (PRMT) indeed plays important~     roles in colon cancer pathophysiology. The PRMT expression level is involved in colon cancer~     patient's survival and has been suggested to be a prognostic marker in colon cancer~     patients. Recently, our group found a novel methylation on epidermal growth factor receptor~     (EGFR), which affected EGFR downstream signaling. investigators further observed the~     methylation event on EGFR not only regulated tumor growth in mouse xenograft model but also~     influenced cetuximab response in colon cancer cell lines. To further study the clinical~     correlation between EGFR methylation and cetuximab response, we propose to detect EGFR~     methylation level in paraffin embedded tissue samples from colorectal cancer patients with~     or without cetuximab treatment by IHC staining and analyze its correlation with cetuximab~     response. This study will provide an insight to the strategy of colorectal cancer therapy.~   "
79030|NCT02022982|"~     This research study is evaluating the experimental drug palbociclib in combination with~     another experimental drug PD-0325901 as a possible treatment for cancers with KRAS~     mutations, particularly for those which started in the lung.~   "
79031|NCT02022969|"~     Even though experimental lung injury in animal experiments is the best analogy for the~     changes in the patients, it has to be considered that kinetics may vary between species. An~     important question to answer is how common PaO2-oscillations occur in patients and how~     injurious they might be. A limitation to the detection of PaO2-oscillations is a sensing~     device that detects the oscillations at very high temporal resolution. In previous studies a~     fiberoptic probe was used, which was measuring PaO2 based on oxygen-sensitive fluorescence~     quenching with a time resolution up to 10 Hz (8, 13, 14). This method is not feasible in~     patients. Previous studies have shown that PaO2-oscillations are translated into the~     peripheral hemoglobin oxygen saturation (SpO2). Given a technology that has a time~     resolution that is high enough (i.e. >1 Hz), measurement of SpO2-oscillations would be a~     valid approach to detecting and quantifying cyclical recruitment and derecruitment in a~     non-invasive fashion in patients on the ICU. The Masimo Rad-8 pulse-oxymeter provides such a~     method. In the current study it is planned to deteted SpO2-oscillations in the~     post-operative patients on the ICU.~   "
79032|NCT02022956|"~     The purpose of this study is to evaluate the PK properties, tolerability, and safety of~     lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old~   "
79110|NCT02021968|"~     Dengue viruses can cause dengue illness ranging from a mild illness to life-threatening~     disease. The purpose of this study is to evaluate the protective effectiveness of a dengue~     virus vaccine in healthy adults.~   "
79111|NCT02021955|"~     This clinical trial is designed to determine whether an intervention that provides~     information to primary care providers about gaps in care for their patients recently~     discharged from hospital for COPD can reduce hospital re-admissions and mortality and~     improve their patients' quality-of-life.~   "
79033|NCT02022943|"~     The Alzheimer's Prevention Registry (www.endALZnow.org) will collect contact and demographic~     information on individuals. The objective is to provide information the latest news and~     advances in Alzheimer's prevention research, and to inform enrollees about research studies~     in their community. Enrolled individuals will receive regular email communications. As~     research studies become available, individuals will be notified via email with information~     as to how proceed should they be interested. Registry enrollees are under no obligation to~     participate in a research study. Study opportunities may include surveys, healthy lifestyle~     interventions (e.g., diet, exercise), memory & thinking tests, brain scans, and~     investigational drug trials. To join the Registry, please visit www.endALZnow.org~   "
79034|NCT02022930|"~     The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy~     for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and~     long lasting pain relief for up to six months with a single IA injection.~   "
79035|NCT02022917|"~     This study is to determine the feasibility of postoperative platinum-based chemotherapy plus~     adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval~     surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.~   "
79036|NCT02022904|"~     This is a minimal risk correlative clinical blood-drawing protocol. The objective of this~     lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be~     captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes~     (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the~     capture method will be evaluated further in the larger comparative study.~   "
79037|NCT02022891|"~     Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long~     care. In children, the disease may cause intense pain and other severe complications.~     Studies show that sources of stress, as well as complex psychological and intercultural~     issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the~     treatment model used is systematic psychological and medical care. Our hypothesis is that~     this care is beneficial for both the children and their families as seen in improved quality~     of life and positive impact on medical symptoms.~   "
79038|NCT02022878|"~     Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing~     coronary angiography. The presence of an untreated CTO has been related to adverse clinical~     prognosis, both in stable angina and acute myocardial infarction, and is often associated~     with persistent symptomatic angina. Depending on their symptomatic and functional status as~     well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy~     combined with coronary revascularization.~      The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom~     relief, improved left ventricular function, and potentially a survival advantage associated~     with success when compared with failed revascularization. Of note, marked advances in~     endovascular techniques and device technology have resulted in substantial improvements of~     procedural success rates of PCI in CTO.~      In spite of these advances, the vast majority of patients with CTO are still being managed~     medically or referred for coronary bypass surgery rather than PCI. The most common reason~     for deferring PCI in patients with CTO appears to be the uncertainty of predicting the~     procedural outcome of percutaneous revascularization. Further barriers to attempting CTO by~     PCI include the difficulty of gauging the time required for the procedure and the use of~     resources.~      The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization)~     study was designed to evaluate the application of coronary computed tomography angiography~     (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient~     population. The main purpose of this multicenter registry is to develop a noninvasive~     CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.~   "
79039|NCT02022865|"~     The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and~     placental, foetal, or uterine pathosis. Maternal infection and placental pathosis appear to~     be the most important causal factors, possibly causing pre-term labour, premature pre-term~     membrane rupture, or result in medically induced pregnancy interruption. There are reports~     of a link between poor maternal periodontal health and composite adverse pregnancy outcome~     of pre-term low birth weight (PLBW). however, the reason for such correlation is still not~     clear.~      In the current study the investigators will try to follow a possible path between~     periodontal infection and uterus physiology, by signaling out inflammatory markers that may~     leak from the gingival fluid into the serum and from there to the amniotic fluid.~      the investigators will collect GCF, serum and amniotic fluid from patients undergoing~     elective amniocentesis and analyse inflammatory markers in the collected samples.~   "
79040|NCT02022852|"~     Compared curative effect，safety and compliance between concurrent chemoradiotherapy and~     chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.~   "
79041|NCT02022839|"~     We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill~     patients candidates to liberation from mechanical ventilation in predicting weaning~     outcomes. The analysis will be taken in two times: immediately before and at the and~     spontaneous breathing trial.~   "
79042|NCT02022826|"~     This protocol is designed to validate use of the SPM for diagnosis of delayed gastric~     emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study~     on patient management in the gastroparetic populations. Patients with symptoms of~     gastroparesis will be recruited.~      Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the~     presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs~     for each technique.~   "
79043|NCT02022813|"~     Having previously demonstrated that supplemental parenteral nutrition to complete an~     insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical~     illness, by reducing infectious complications, the present trial aims at investigating the~     underlying carbohydrate and protein metabolism changes, as well as the immune and~     inflammatory modulations associated with this improvement.~   "
79112|NCT02021942|"~     This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230~     LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka~     II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The~     purpose of this trial is a proof of concept.~   "
79044|NCT02022800|"~     In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral~     tumor, there is currently complex clinical situations in which the clinic and Magnetic~     Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive~     diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at~     least 3 months in order to clarify the situation, with a potential delay in diagnosis and~     therefore therapeutic care. The contribution of cerebral molecular imagery could allow for~     new additional information to be brought in or to increase the confidence index in the~     diagnosis in order to comfort the therapeutic collective attitude proposed in the~     multidisciplinary meeting (MM).~      3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid,~     Position Emission Tomography (PET), allows for the studying in vivo of the proteic~     transmembrane transport in gliomatous tissue; active transport happens through a~     sodic-independent canal, increased in malicious transformations, and in which kinetics can~     give an indication regarding the development of the primary tumor.~      In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in~     the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is~     independent of the state of integrity of the BBB and whose only function is metabolic tissue~     activity. This method of imagery thus appears as a promising contribution to conventional~     imagery.~      Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose),~     similar to the largely used glucose in oncologic molecular imagery, exploration of harmful~     glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless~     in a healthy cerebral cortex, with the exception of striatal physiological fixation used as~     a level of reference. The best performances in terms of positive and negative predictive~     value were defined in the literature with a tumor/striatum threshold of 1.~      According to the latest and current European recommendations, turning to PET when caring for~     high-level gliomas patients can be proposed in the evaluation of therapeutic responses.~     However, very few studies have evaluated the in-practice current clinical contributions of~     PET and put it into perspective with classic clinical radiological data.~   "
79045|NCT02022787|"~     This study was designed as a pilot study to try and find a Chemokine that may be specific~     for renal cell carcinoma~   "
79046|NCT02022774|"~     The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in~     patients with hypertension~   "
79047|NCT02022761|"~     This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose~     study, in which the safety and pharmacokinetics of laninamivir octanoate administered by~     inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic~     asthma.~   "
79048|NCT02022748|"~     A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and~     tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal~     function.~   "
79049|NCT02022735|"~     The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on~     walking in patients with Parkinson's disease that have had DBS. While DBS improves~     Parkinson's disease (PD) symptoms and walking in many patients in some of the patients~     walking problems persist. This study aims to find out what are the best stimulation~     parameters of the DBS in order to improve walking.~   "
79050|NCT02022722|"~     The purpose of this study is to evaluate which treatment option for pelvic floor pain allows~     for improved sexual function.~   "
79051|NCT02022709|"~     The purpose of this study is to evaluate the efficiency of SSRIs（Selective Serotonin~     Reuptake Inhibitor） ,ERP（Exposure and Response Prevention） and the combination of the two~     therapies for OCD(Obsessive-Compulsive Disorder) patients ,at the same time, to find out the~     biological or psychological predictors of treatment response in Chinese population.~   "
79052|NCT02022696|"~     This is a clinical gene transfer study that aims to verify the safety and efficacy of the~     use of the EFS-ADA lentiviral vector to introduce the human adenosine deaminase (ADA) gene~     into the hematopoietic progenitors of patients affected with severe combined~     immunodeficiency due to ADA deficiency. The EFS-ADA vector expresses the human ADA cDNA~     under the control of the elongation factor alpha short promoter (EFS). In addition, this~     protocol will examine the effects of the ADA gene transfer on the immune system of treated~     patients. Patients with ADA deficiency and ineligible for matched sibling allogeneic bone~     marrow transplantation are eligible to participate in the study. To increase engraftment and~     selected advantage or gene-corrected cells, busulfan will be used as a cytoreductive agent.~     Enzyme replacement (PEG-ADA) will be discontinued 30 days after infusion of gene-corrected~     cells. CD34+ hematopoietic progenitors will be isolated from the patient bone marrow,~     peripheral blood or cord blood, exposed to lentiviral vector-mediated gene transfer and~     re-infused into the patient through a peripheral vein. Clinical, immunological and molecular~     follow-up studies will assess safety, toxicity, and efficacy of the procedure.~   "
79053|NCT02022683|"~     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr~     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous~     emphysema patients in a controlled trial design setting.~   "
79054|NCT02022670|"~     The proposed research will determine the effectiveness of nitrite, a naturally occurring~     compound in the body, for improving the health and function of arteries in middle-aged and~     older adults. The study also will provide insight into how sodium nitrite therapy improves~     artery health by determining the physiological mechanisms (biological reasons) involved.~     Overall, the proposed research will provide important new scientific evidence on the~     effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular~     diseases with aging.~   "
79055|NCT02022657|"~     The primary objective of this study is to define the mean, variance, and dose~     proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%,~     67%, and 100% of daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil~     fumarate (as Truvada®). With this information, a model will be established to predict~     adherence rates to TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants~     who are at low risk for HIV infection will be randomized to one of 6 sequences consisting of~     two directly observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and~     100%/67% with each dose regimen lasting approximately 12 weeks, separated by an~     approximately 12 week washout period. DBS will be collected at regular intervals, including~     during the washout. The hypothesis of the study is that levels of TFV-DP in DBS will predict~     adherence rates in the preceding 1-3 months.~   "
79056|NCT02022644|"~     This is a dose-toleration study designed to investigate and determine the maximum tolerated~     dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when~     administered directly into the tumor using a process called convection-enhanced delivery.~     (CED)~   "
79113|NCT02021929|"~     The main purpose of this clinical trial is to determine the safety and effects of the study~     drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will~     evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood~     and the function of the lung vessels.~   "
79057|NCT02022631|"~     The investigators will conduct a parallel two-armed, non-inferiority randomized trial~     comparing new alternative formats of summary of findings tables (SoF) tables with current~     formats. The investigators will contact Cochrane review users by email and will ask them to~     fill a questionnaire developed using the Survey Monkey online system. The survey will~     include questions about baseline information (demographic characteristics, background,~     number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then,~     participants will be stratified (health professional, guideline developer, researcher) and~     randomly assigned to one of the two SoF table formats, either the alternative (Table A) or~     the current one (Table C). Participants will be asked to answer questions to determine~     understanding, accessibility, and satisfaction with the formats to which they were~     randomized. Finally, the investigators will show them the table format to which they were~     not initially allocated in order to test their preference for either one.~   "
79058|NCT02022618|"~     Objectives: To analyze the influence on the presence of target organ damage renal, cardiac~     and vascular of peripheral and central blood pressure, retinal vessels caliber, oxidative~     stress and polymorphisms of genes VAV-2-3 in hypertensive subjects.~      Methodology: A cross- sectional design we will performed . Population: 486 hypertensive~     patients. Target organ damage will be assessed by tests recommended in 2013 European~     guidelines of hypertension. Blood pressure office and ambulatory, retinal caliber~     vassels,oxidative stress and polymorphisms VAL -2-3 will be measurement.~   "
79059|NCT02022605|"~     Previous studies have demonstrated that coached EMS practice at the beginning of ERCP~     training could improve the trainees' skill. However, it is not known whether continuously~     coached practice using EMS can provide additional benefit.~   "
79060|NCT02022592|"~     A goal directed , demand-driven administration of sedative drugs is an integral part of~     every intensive care treatment. During long-term application of sedatives, Midazolam is the~     most commonly used sedative in Europe.~      One major objective is the problem of oversedation and agitation during an intensive care~     treatment due to the lack of controllability of available substances.~      The Love-Mi RCT investigates the clinical controllability of Midazolam versus the newly~     available intravenous drug Lormetazepam.~   "
79061|NCT02022579|"~     A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested~     to define cancerous from non-cancerous lesions in the breast.~   "
79062|NCT02022566|"~     Physical activity level is measured at baseline and after 3 and 12 months after structured~     information and individually adapted exercise for patients with osteoarthritis in hip or~     knee.~      The hypothesis of this study is that a supported self management of osteoarthritis program~     will increase the level of physical activity in patients with osteoarthritis in hip or knee.~     The second hypothesis is that patients with osteoarthritis in knee will increase their level~     of physical activity more than patients with osteoarthritis in hip.~   "
79063|NCT02022553|"~     AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment~     of patients with locally advanced rectal cancer using endovascular methods and reservoir and~     plastic surgery.~      TASKS OF RESEARCH.~        1. To assess the immediate and long-term results of combined (chemoradiation and surgical)~          treatment for locally advanced rectal cancer.~        2. To make a comparative evaluation of the results of independent surgical and combined~          (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.~        3. To examine functional results of surgical treatment with the formation of~          neosphincter and neorectum in patients with colorectal cancer..~        4. To study features of blood supply to the rectum from the pools of the inferior~          mesenteric and internal iliac arteries, using the method of selective angiography, in~          connection with the development of endovascular treatment of rectal cancer.~        5. To develop and introduce into clinical practice method of one-stage selective~          intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in~          patients with locally advanced rectal cancer, who have a contraindication to~          preoperative radiotherapy.~        6. To assess the immediate and long-term results of combined (endovascular and surgical)~          treatment for locally advanced rectal cancer.~        7. To optimize tactics of combined treatment of locally advanced rectal cancer by~          developing an algorithm of using chemoradiotherapy and endovascular interventions in~          the preoperative period.~      NOVELTY OF RESEARCH.~        1. As a result of research will be designed and implemented a new method of selective~          intra-arterial chemoembolization in rectal arteries preoperatively in patients with~          locally advanced rectal cancer.~        2. Substantiated high effectiveness of the proposed technique for the removal of colonic~          obstruction and, as a consequence perform radical surgical treatment of these patients.~        3. First developed dosage and concentration of chemotherapeutic agent and embolic agent~          for safe injection when performing selective intra-arterial chemoembolization of rectal~          arteries.~        4. Developed complex techniques of selective intra-arterial chemoembolization of rectal~          arteries preoperatively in patients with locally advanced rectal cancer.~        5. Will be made a comparative analysis of the postoperative period and the evaluation of~          the quality of life of operated patients Obtained data will be presented for use in~          clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use~          in the treatment process of departments of Coloproctology, oncology, as well as the~          educational process of higher and secondary medical institutions.~      EXPECTED EFFECTIVENESS.~      It is expected that the use of this method of treatment of patients with locally advanced~     rectal cancer in clinical practice will provide pronounced effect:~        1. Medical and social - improving the quality of care, preservation of social activity of~          patients, reducing mortality;~        2. Economic - reducing the time of patients' treatment and reducing the number of~          therapeutic manipulation;~        3. Science and Technology - improving of the training level of medicine workers in the~          treatment of patients with rectal cancer.~   "
79064|NCT02022540|"~     The objective of this study is to assess the safety and tolerability of topical ocular~     PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with~     neovascular Age-Related Macular Degeneration (AMD).~   "
79065|NCT02022527|"~     The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and~     overall mortality. Also the initiation of an efficacious early anticoagulation protocol is~     important because of its potential impact on the rate of early thromboembolic complications~     after mechanical valve implantation. An important question that remains to be answered is~     whether the combination would be cost effective than Warfarin alone, with a reduction in~     major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been~     established in Egypt. The aim of this trial based economic evaluation is to conduct a~     cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin~     alone in prosthetic valve patients from the medical provider perspective specially that a~     misconception is still existed between the physicians in Egypt that the cost of~     complications is not worthy so our main aim is to test the cost of complications.~   "
79066|NCT02022514|"~     Clinical trial phase III, prospective, controlled, randomized, open.~      We hypothesize work that patients with chronic coronary occlusion and poor myocardial~     viability who failed to recover ventricular function after subjecting coronary~     revascularization with new techniques of recanalization, could achieve an improvement of~     ventricular function if given further regenerative treatment with mononuclear cells from~     autologous bone marrow.~      To test this hypothesis we designed a prospective, randomized clinical trial in patients~     with recanalized chronic occlusions and ventricular dysfunction.~   "
79067|NCT02022501|"~     The purpose of this study is to assess the safety, tolerability, bioactivity and~     pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in~     subjects with late stage exudative age-related macular degeneration.~   "
79114|NCT02021916|"~     To provide appropriate collection, storage, and distribution of specimens and medical data~     to local investigators who have approved IRB protocols for their specific research purposes.~   "
79068|NCT02022488|"~     Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral~     midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children,~     undergoing urological surgery with sevoflurane anesthesia was included in the study. All the~     children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then~     enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were~     given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given~     10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline~     group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask~     acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with~     Pediatric Anesthesia Emergence Delirium score.~   "
79069|NCT02022475|"~     Primary objective~      -Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum~     7) days after oral administration of 100 000 E vitamin D (Cholecalciferol).~      Secondary objectives~        -  Effect of oral administration of vitamin D on serum vitamin D levels~          (25-Hydroxy-Vitamin D = Colecalciferol), PTH, Calcium, and Phosphate as compared to~          placebo.~        -  Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short~          self-developed FCA-Test~        -  Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral~          placebo. Laboratoty parameters such as serum calzium and phosphate levels and the~          number of adverse events compared to placebo will be used for safety monitoring.~        -  Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23,~          Sclerostin and Klotho levels compared to placebo.~   "
79070|NCT02022462|"~     The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of~     the general population, meaning that those with a serious mental illness die, on average, 25~     years earlier than those without an SMI. These deaths are largely attributed to preventable~     medical conditions, many of which are more common in the SMI population.~      The Bridge intervention is a peer navigator model that was developed to target factors~     that negatively impact healthcare access, utilization, and outcomes among individuals with~     serious mental illness (e.g., severe mood disorders and psychotic disorders). This~     intervention targets male and female, adult consumers across races/ethnicities and has been~     utilized by Pacific Clinics (Southern California's largest behavioral healthcare agency) and~     the Department of Mental Health of Los Angeles County to improve the health and quality of~     life for their consumers.~      Investigators will test the comparative effectiveness of a peer navigator intervention (the~     Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI~     consumers the skills to engage health care providers and to overcome motivational deficits~     in order to improve their health and healthcare use. The specific aims of this application~     are:~        1. To use randomized methods to examine the effectiveness of the Bridge intervention on~          the health care utilization, satisfaction with care, health status, and health care~          self-management for a sample of individuals with severe mental illness receiving public~          mental health services in the community;~        2. To use randomized methods to examine the effectiveness of the Bridge intervention on~          psychological and social well-being for a sample of individuals with severe mental~          illness receiving public mental health services in the community.~      Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific~     Clinics will be recruited to participate in an approximately 24 month long study of Bridge~     navigation. Participants will be randomly assigned to either treatment as usual (waitlist)~     or immediate intervention with the Bridge.~      Participants in both groups will complete three assessments (baseline, 6 months, 12 months)~     and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed~     at baseline and every three months of the study in order to ensure that the intervention is~     being implemented appropriately.~   "
79071|NCT02022449|"~     To explore maternal biological (activation of the hypothalamic-pituitary-adrenal axis) and~     behavioral (smoking, sleep behavior, exercise and alcohol use) pathways of~     intervention-related decreases in inflammation. Hypothesis: The intervention group will show~     decreased levels of cortisol and improved health behaviors from pre- to post-intervention~     when compared with the control group. We will also explore whether intervention-related~     changes in these parameters predict symptoms of illness. Exploratory Aim 2. To explore~     psychological pathways of intervention-related decreases in distress among mothers,~     including the perception of social support and the use of behavioral coping strategies that~     are components of the intervention. Hypothesis: Increases in perceived social support and~     use of active behavioral coping strategies will be associated with intervention-related~     decreases in symptoms of depression, anxiety and psychological stress.~   "
79072|NCT02022436|"~     The goal is to non-invasively study the metabolic processes within the aortic wall that are~     thought to explain progression to clinical manifestations of an aortic aneurysm.~      Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast~     ultrasound, coupled with serum biomarker measurements will allow the identification of the~     vulnerable aortic wall and patients who are at risk of AAA growth or rupture.~   "
79073|NCT02022423|"~     With the aging of the American population, the numbers of adults with peripheral arterial~     disease (PAD) will increase significantly over the next several decades. Patients with PAD~     are at increased risk for morbidity and mortality including both cardiovascular and~     all-cause mortality. While regular physical activity reduces risk for vascular events and is~     recommended for treatment of PAD patients, few patients meet recommended goals. Exercise~     programs which increase long-term adherence to walking can be an important contribution to~     PAD treatment. Our Internet-based intervention, with an online community builds on a walking~     enhancement program developed by members of our team and is shown to improve adherence among~     patients with vascular disease such as coronary artery disease (CAD). Using a randomized,~     controlled trial study design, we propose to test an automated Internet-based walking~     program with a social media component, to improve long-term adherence to walking while~     increasing walking distance, and health-related quality of life, among patients with PAD.~     Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling,~     2) an Internet-based walking program, 3) a combination of telephone counseling and~     Internet-based walking program, or 4) a usual care group. The Internet-based walking program~     with a social media component has been shown to increase both adherence to walking and~     overall walking duration in populations with chronic complex conditions such as CAD and~     diabetes. There is a strong need to develop interventions, easily generalizable to a~     real-world population, to improve the reach of lifestyle interventions which result in~     improved physical function and adherence to regular exercise among complex medical patients.~     High risk patients such as those with PAD (a CAD risk equivalent) stand to benefit the most~     from such programs.~   "
79074|NCT02022410|"~     The purpose of the study is to prospectively evaluate patients who underwent total knee~     arthroplasty (TKA) using the Cumulated Ambulation Score (CAS)~   "
79075|NCT02022397|"~     General anaesthesia mandates artificial ventilation and tracheal intubation in order to~     provide patients with artificial breathing. Difficulties related to ventilation and~     intubation remain the leading cause of morbidity and mortality in general anaesthesia,~     essentially due to inaccuracies in pre-operative detection of anatomical factors~     predisposing to difficult airways. In this project investigators will develop image and~     video-processing technologies software solutions to allow automatic recognition of~     anatomical features playing a key role in identification of difficult ventilation and~     intubation, leading to modifications in pre-operative anaesthesia management assessment and~     therefore increase patients' safety.~   "
79238|NCT02020252|"~     The purpose of this research study is to test a touchscreen computer program, which allows~     patients to see information on a computer screen regarding cancer care, and specifically~     clinical trials. The purpose of this research is to help the investigators learn more about~     how to use technology in the medical setting to improve health outcomes.~   "
79077|NCT02022371|"~     The purpose of this study is to carry out very detailed genetic testing on prostate cancer~     cells. The reason to do this is because researchers do not fully understand~        -  How prostate cancer develops~        -  Why some cancer cells spread and others do not~        -  Why some cancer cells respond to treatment and others do not~      Researchers and doctors know that 1 in 3 of the male population over the age of 50 has~     cancer cells in their prostate. However, most of these men will never know they have it and~     it will not affect their quality of life or their life expectancy. However, some cancers can~     be aggressive. These are more likely to spread outside of the prostate and cause problems.~     Doctors do not have an accurate way to tell the difference between aggressive cancer and~     those which will not cause any problems. Even within one prostate some tumours are~     aggressive and others do not cause a problem during the lifetime of a patient. In fact, even~     within one tumour, different cells may behave differently. In other words, one part of the~     tumour may be aggressive and spread, whilst another part of the same tumour does not. This~     project will try to find out more about what makes different tumours and different parts of~     the same tumour aggressive or harmless.~      It is important to find out what makes some cancer cells spread and others stay where they~     are. For the investigators to do this they need to collect fresh samples of cancer tissue~     from the prostate and from different areas of a tumour within the prostate. This is because~     biopsies used to diagnose or exclude cancer by the hospital laboratory are not good enough~     to give investigators detailed genetic information. These biopsies have been put into a~     chemical called formalin which reduces the quality of the genetic information.~      Investigators are therefore asking patients who are undergoing prostate biopsies as part of~     their normal care to allow them to take additional biopsies for the purpose of this study.~     This may be the first time patients are having biopsies. Or, patients may be having biopsies~     after treatment that has been given for the cancer and the doctors are concerned the~     treatment is not working.~   "
79078|NCT02022358|"~     Methotrexate is one of the most effective chemotherapy drugs in the treatment of~     osteosarcoma and some other types of bone sarcoma which are treated the same way as~     osteosarcoma. However, it frequently leads to sore mouth, tummy pain and increased risk of~     developing infections.~      The investigators try to save or rescue normal cells from the side effects of methotrexate~     by giving a drug called folinic acid. Folinic acid is started 24 hours after methotrexate~     and given regularly until methotrexate levels are really low and not dangerous to normal~     cells anymore. Despite this rescue, side effects are still a problem and many patients are~     not well enough to receive subsequent chemotherapy on time. Almost half of the planned~     chemotherapy cycles are not given on time due to methotrexate side effects.~      In this study the investigators will examine if adding a drug called glucarpidase to folinic~     acid is helpful. Glucarpidase is an enzyme that inactivates methotrexate in the blood~     stream. Lower methotrexate concentration in the blood stream leads to fewer side effects.~     The investigators would like to see if glucarpidase helps patients to have their~     chemotherapy on time, by reducing the side effects of methotrexate.~   "
79079|NCT02022345|"~     To evaluate the introduction of Percutaneous Coronary Intervention without Onsite Surgery in~     the largest state, California (CA) began a pilot PCI program in 6 hospitals without onsite~     cardiac surgery and then compared the PCI results in the pilot hospitals with results in 120~     non-pilot hospitals. The pilot program qualification incorporated appropriate planning and~     rigorous hospital, operator, patient, and lesion selection criteria.~   "
79080|NCT02022319|"~     Background: The main goal of diagnosing thyroid nodules is to differentiate the few~     malignant from the large background of benign lesion. Currently available pre-operative~     tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is~     necessary. Therefore there is a need to develope the available diagnostic tools for the~     pre-operative diagnostic work-up of thyroid nodules.~      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography~     (SWE) in the pre-operative evaluation of thyroid nodules.~      Hypothesis:~      1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and~     intra-observer reliability and day-to-day variation.~      The study will be conducted as part of a larger PhD study, and an evaluation of the~     diagnostic value of thyroid SWE will be evaluated in a larger study.~      Perspectives:~      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules~     can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the~     economic and surgical resources.~   "
79081|NCT02022306|"~     This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD)~     study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy~     subjects.~   "
79082|NCT02022293|"~     Patients with head and neck cancer who underwent irradiation have a higher risk of~     developing severe carotid stenosis, and eventually develop to transient ischemic attack or~     stroke. However, it's still not clear whether early intervene in vascular risk factors is~     benefit for patients after radiotherapy.~      Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC~     patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind,~     placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled~     from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo~     group.~   "
79083|NCT02022280|"~     In this randomized controlled crossover study, the investigators propose to test the~     hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric~     dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose~     to evaluate ADMA concentrations and vascular function analysis in healthy volunteers and~     adults with a history of cardiovascular disease given PPI vs placebo for four weeks each.~   "
79084|NCT02022267|"~     Patients with clubfoot treated with the Ponseti method from a prospective database are~     evaluated using gait analysis including a foot model and a disease specific instrument score~     and compared to a group of healthy children.~   "
79085|NCT02022254|"~     This trial is conducted in Europe and Asia. The aim of the trial is to investigate the~     influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body)~     and pharmacodynamics (the effect of the investigated drug on the body) of warfarin and~     pharmacokinetics of metformin in healthy subjects.~   "
79086|NCT02022241|"~     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte~     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian~     hyperstimulation syndrome (OHSS) in high-risk patients.~      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)~     level post trigger with single injection of GnRH agonist, which might be related to the~     shorter duration and lower amount of LH induced by GnRH agonist.~      Our aim is to study repeated injection of GnRH agonist for preventing OHSS and maintaining~     clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH~     antagonist protocol.~   "
79249|NCT02020109|"~     Retrospective evaluation on the effect of splenic irradiation on clinical and hematological~     response and toxicity in patients with chronic lymphatic leukaemia (CLL).~   "
82304|NCT01980095|"~     The test and treat strategy for treating dyspeptic patients who are H. pylori positive is~     rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a~     new triple therapy to treat H. pylori infection in dyspeptic patients.~   "
79087|NCT02022228|"~     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte~     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian~     hyperstimulation syndrome (OHSS) in high-risk patients.~      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)~     level post trigger with single injection of GnRH agonist, which might be related to the~     shorter duration and lower amount of LH induced by GnRH agonist.~      Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG)~     for preventing OHSS and maintaining clinical outcome in high risk patients who receive~     controlled ovarian stimulation in GnRH antagonist protocol.~   "
79088|NCT02022215|"~     The purpose of the study is to determine the safety and efficacy of high and low strength of~     ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.~   "
79089|NCT02022202|"~     The purpose of this research study is to better understand the reasons why or why not breast~     cancers are destroyed by standard chemotherapy. This information will be used to develop new~     and better cancer therapies.~   "
79090|NCT02022189|"~     This study is being done to obtain pathology reports from all patients in the Dent disease~     registry who have had a kidney biopsy. The investigator will collect the biopsy slides and~     reports in an attempt to determine if they have any common findings.~   "
79091|NCT02022176|"~     The purpose of this study is to determine the effects of sodium nitrate on resting metabolic~     rate, glucose uptake and formation of reactive oxygen species in humans.~   "
79092|NCT02022163|"~     A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging,~     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2~     intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy~     adults, 18-60 years of age.~   "
79093|NCT02022150|"~     Ascites is a frequent complication of liver cirrhosis, initial treatment consists on~     diuretics intake, however, as the disease progresses this complication becomes more severe,~     consequently other therapeutic options are used.~      Paracentesis is indicated when severe ascites is present and it should be accompanied by~     albumin infusion.~      Nutritional status is generally affected in patients with liver cirrhosis, even more~     patients with severe ascites show decreased energy intake due to gastric compression.~   "
79094|NCT02022137|"~     As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans~     have shown prebiotic effects, and have shown to improve function of the digestive system,~     control and induce glycemic effect satiety. Therefore the impact of the fermentation of such~     prebiotic in the gut may contribute to improving health and quality of life of patients with~     MHE.~   "
79095|NCT02022124|"~     Patients will be randomized to receive open-label (honestly described placebo) immediately~     at baseline or be eligible to receive the open-label treatment three weeks after the~     baseline measurements. Therefore all patients will be eligible to receive open-label placebo~     treatment for their chronic low back pain during the course of the study.~   "
79096|NCT02022111|"~     To provide better care and preventive services for people with both depression and diabetes,~     the investigators propose to develop and test whether interventions to reduce depressive~     symptoms can be integrated into routine diabetes clinics in India. The investigators will~     gather feedback from patients in India through focus group discussions and individual~     interviews so they can culturally-adapt a model of combined depression and diabetes care.~     The investigators will then evaluate the effectiveness and costs of this care model in a~     trial at three diabetes clinics in India. It is expected that results from this study can~     guide how to incorporate mental health care into routine diabetes clinics in low-resource~     settings.~   "
79097|NCT02022098|"~     The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become~     common, particularly in the treatment of cancer. Because traditional trials are designed to~     evaluate one agent at a time, the evaluation of therapies in combination requires~     specialized trial designs. In place of the traditional separate phase I and II trials, this~     trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and~     efficacy of combination dose levels, and select the optimal combination dose.~      Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and~     radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and~     neck cancer. The trial begins with an initial period of dose escalation (Phase I) to~     investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in~     combination with CRT.~      Using the MTD determined in the Phase I portion, the randomized phase II trial in 94~     participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to~     evaluate the efficacy and safety of Debio 1143.~   "
79098|NCT02022085|"~     The rationale behind this post-market clinical follow-up investigation is to collect data~     regarding the usability and clinical performance of the Baha Attract System in subjects with~     hearing impairment that are candidates for Baha surgery:~        -  to evaluate the efficacy of the Baha Attract System in terms of hearing performance~          compared to the unaided situation and compared to a pre-operative test situation using~          the sound processor on a Baha Softband;~        -  to evaluate the mid- and long-term safety of the Baha Attract System.~   "
79099|NCT02022072|"~     Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of~     this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory~     vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital~     capacity (VC) according to pathology and severity of pulmonary damage of patients with~     neuromuscular diseases. The methodology consists in realize VC by support of~     inspiratory/expiratory pressures, while the patient is passive and realizing a maximal~     inspiratory/expiratory effort simultaneously, with the aid of mechanical~     insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes~     and the non-inclusion criteria are those for an insufflation. The study hypothesis is that~     long term insufflation/exsufflation device use could improve thoracopulmonary mobility.~   "
79264|NCT02019914|"~     The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea~     (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic~     stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms~     overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms~     related to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health~     perception.~   "
79100|NCT02022059|"~     Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT)~     is although a common act. Unfortunately, this procedure can be painful. Also, many patients~     will need many NGT re-insertion. Therefore, the investigators need to increase the~     acceptability of this procedure by increasing comfort during NGT passage. Professionals~     guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP~     (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using~     local anesthesic without ordering their use. However, NGT tube insertion is often put~     without pre-medication in the face of an accumulating body of evidence indicating that local~     anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand,~     these studies have been done in the emergency room with NGT of a bigger gauge and for many~     reasons except enteral nutrition.~      The investigators primary objective of this prospective monocentric study is to evaluate the~     efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before~     NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary~     objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of~     NGT insertion using Likert scale, numbers of try, time of procedure, complications like~     tracheal insertion and success of the insertion using thorax x-ray.~      The study will be held in CHU Nice at nutrition unit support. After signed consentment,~     patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B~     (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2~     minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be~     noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the~     patient will have to answer a questionnaire. Pain will be grade using visual analogue scale~     immediately after the procedure. Demographic data and complications will be note by the~     investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be~     34 patients by group. If the investigators find a benefit, this can change their practice~     and guidelines.~   "
79101|NCT02022046|"~     Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan.~     Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric~     oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase~     inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as~     a methylation biomarker.~      In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may~     affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor.~     S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase~     (MTHFR), a folate metabolism enzyme can regulate methylation pathway.~      The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene~     methylation can serve as biosignature to predict CVD in children with CKD children.~   "
79102|NCT02022033|"~     The investigators preliminary data suggests that FOLFOX-A may have equal or superior~     activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A~     may be a better regimen in the adjuvant setting for patients with resected pancreatic~     cancer. This protocol will obtain preliminary data on safety and disease-free and overall~     survival following administration of FOLFOX-A for patients with resected pancreatic cancer.~   "
79103|NCT02022020|"~     This study is being conducted to collect data on the management of gastrointestinal and~     urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran~     etexilate.~   "
79104|NCT02022007|"~     The objective of the present proposal is to compare the clinical, endocrine and metabolic~     effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin~     monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT).~     Saxagliptin is an oral dipeptidyl peptidase IV (DPP-4) inhibitor whose mechanism of action~     is to prolong the duration of blood glucagon-like peptide (GLP-1) and glucose-dependent~     insulinotropic polypeptide (GIP) levels by inhibiting their degradation and thereby~     augmenting insulin secretion. This study will serve as a pilot investigation to open~     perspectives for future studies to explore the potential of combining anti-diabetic drugs~     with different mechanisms of action in in patients with PCOS and impaired glucose regulation~     (IGR), especially ones for whom standard treatment with metformin is less effective.~   "
79105|NCT02021019|"~     Sympathetic activation is a hallmark of end-stage renal disease and adversely affects~     cardiovascular prognosis. Hypertension is present in the vast majority of these patients and~     plays a key role in the progressive deterioration of renal function and in the exceedingly~     high rate of cardiovascular events. Selective catheter-based renal denervation has been~     shown to be safe and effective in attaining improved and sustained blood pressure control in~     patients with resistant hypertension and normal renal function. The investigators~     hypothesize that catheter-based renal denervation is a safe and effective intervention to~     achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in~     hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved~     cardiovascular outcomes.~   "
79106|NCT02021006|"~     The exact role of urinary tract infection in the appearance of chronic kidney disease is~     unclear. Children with congenital malformations of kidney and urinary tract have the higher~     risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can~     reduce the risk of urinary tract infection in children with these malformations, this study~     will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B~     will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic~     prophylaxis reduce the risk of urinary tract infections in these children and if urinary~     tract infections influence the appearance of renal damage.~      Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral~     reflux and that urinary tract infections, in morphologically normal kidneys, will not result~     in chronic renal failure.~   "
79107|NCT02020993|"~     There is a need for a biochemical marker in addition to clinical condition which will help~     the physician to understand the clinical progress of the disease.~      Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not~     been evaluated for respiratory distress in newborn.~      The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory~     diseases in newborns by a controlled trial.~   "
79108|NCT02021994|"~     The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with~     blood pressure monitor device.~      The cuff range is as follows:~      15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm~   "
79109|NCT02021981|"~     This quality improvement project is focused on improving hypertension care delivery~     processes in ambulatory clinical practices, 5 in Illinois and 5 in Maryland for a total of~     10 practice sites.The primary aim of this quality improvement project is to improve blood~     pressure control among patients receiving routine care for hypertension in a diverse group~     of ambulatory clinical practices. A secondary aim is for American Medical Association (AMA)~     and Johns Hopkins Medicine (JHM) quality improvement staff to figure out the best way to~     help clinical practices in achieving improved blood pressure control, including working to~     increase the use of home blood pressure monitoring.~   "
79115|NCT02021903|"~     Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's~     disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It~     is a major complain and represents a socially relevant problem as unintended episodes of~     sleep can also occur while driving for example. Arterial hypotension is frequently observed~     in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness~     is known to occur preferentially when patients are having arterial hypotension whatever the~     cause (i.e. postprandial period, administration of hypotensive medication such as dopamine~     agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness.~     We have observed this association in an on-going epidemiological survey Hyperglycaemia~     induced by oral glucose load - a standardized model simulating food intake during a meal -~     provokes arterial hypotension in the majority of Parkinson's disease patients with~     dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated~     by this fall in blood pressure.~   "
79116|NCT02021890|"~     to test the metabolic and clinical effects of a 6-month program of dancing in subjects with~     type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units.~     Self-selection of the leisure time activity program was allowed to increase adherence to the~     physical activity programs.~   "
79117|NCT02021877|"~     Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain~     trauma will be asked to participate in the study. This prospective database will consist of~     400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition,~     100 controls will be recruited, with 50 from both centres.This study is a prospective~     clinical observational study with detailed data collecting. All patients will be treated~     according to the accepted, standardized, existing guidelines that are based on national and~     international recommendations. New treatment interventions will NOT be evaluated during the~     data acquisition for this study.~   "
79118|NCT02021864|"~     -  Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D~          will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and~          25(OH)D less than 30ng/ml will be entered to study. .~        -  Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe~          preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios,~          parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti-~          convulsive and immunosuppressive drugs.~        -  Participants will randomly assigned in to two groups of intervention and control groups~          .Randomization will be done by random number generator. Intervention group will receive~          weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing~          elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily~          prenatal multivitamin.~        -  At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during~          study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length,~          weight, head circumference ) will be compared between two groups.~   "
79119|NCT02021851|"~     Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The~     incidence can be as high as 80 percent in high-risk patients. Investigators designed this~     randomized, double- blind, single-center study to compare the efficacy of the combination of~     dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic~     surgery.~      Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years~     patients scheduled for laparoscopic surgery were included in this study. Anesthesia was~     induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen /~     air mixture in all patients. Remifentanil was continuously infused during surgery. Patients~     were randomly divided into two groups. Patients in the dexamethasone and aprepitant group~     (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of~     anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients~     in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo~     identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv~     within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after~     induction of anesthesia.~      PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The~     blindly evaluated primary outcome was complete response. The secondary outcomes were~     incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid~     consumption within 24 hours after surgery. Statistical analyses were performed using~     Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered~     statistically significant.Investigators hypothesized that the antiemetic efficacy of the~     aprepitant and dexamethasone combination is superior compared with ondansetron and~     dexamethasone combination following the laparoscopic surgery.~   "
79120|NCT02021838|"~     In collaboration with the National Institute of Justice (NIJ) and the Office for Violence~     Against Women (OVW) the Yale University team will evaluate the implementation process and~     impact of the U.S. Department of Justice's Domestic Violence Homicide Prevention~     Demonstration Initiative. This evaluation seeks to draw critical findings and potential~     lessons from the combined experience of the sites including: 1) how the models work in~     different communities; 2) the barriers and facilitators to implementing the models; and 3)~     outcomes of the model delivery. The evaluation team will also disseminate the findings with~     the goal of informing replication.~   "
79121|NCT02021825|"~     The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2~     years. Dosage was adjusted according to side effects. Neurological assessment including the~     determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic~     evaluations were performed every 3 months and during relapses. Flow cytometric analysis,~     brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.~   "
79122|NCT02021812|"~     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic~     Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta~     (DTA)~   "
79123|NCT02021799|"~     The purpose of this study is to determine whether a difference exists in the gut, oral,~     vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy~     and obese pregnant women. In addition, the investigators are setting out to determine if a~     micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of~     under-nourished pregnant women.~   "
79124|NCT02021786|"~     This study aims to evaluate the effects of a mobile phone-based dietary and physical~     activity intervention on body fatness, dietary intake and physical activity of preschoolers~   "
79125|NCT02021773|"~     The purpose of the study is to determine whether monthly subcutaneous administration of~     LBR-101 is safe and provides migraine prevention in patients with chronic migraine.~   "
79561|NCT02016053|"~     500 patients with normal renal function will be prospectively studied and incidence,~     spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in~     200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will~     be prospectively studied for 1 year. Also biomarkers will be studied and validated as early~     predictors of AKI (Acute Kidney Injury).~   "
79126|NCT02021760|"~     -  Trial objective: To test the hypothesis that remote per-postconditioning in connection~          with primary PCI will reduce myocardial infarct size patients with STEMI.~        -  Trial Design: Placebo controlled randomized study with parallel groups~        -  Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium~          at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7~        -  Efficacy Parameters: Myocardial infarct size expressed as a percentage to the~          myocardium at risk determined by CMR at 6 months.~        -  Global left ventricular function determined by left ventricular ejection fraction~          determined by CMR.~        -  Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular~          volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters~          day 180.~        -  Safety Parameters: Major adverse cardiovascular events.~   "
79127|NCT02021747|"~     Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers~     to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization~     towards a distinct phenotype associated with impaired host defense function against Mtb and~     that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage~     (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.~   "
79128|NCT02021734|"~     There are certain categories of diseases which are more prevalent in the Arab world due to~     increased rates of consanguinity in relatively isolated populations. The goal is to discover~     these mutations by using next-generation human genetics tools.~   "
79129|NCT02021721|"~     Hypothesis: To identify new gene mutations that can be related to patients with idiopathic~     male factor infertility.~      Primary Objective: To detect possible genetic abnormalities in families with more than one~     sibling with male infertility.~      Secondary Objective: To evaluate using next generation DNA sequencing in cases of~     infertility~   "
79130|NCT02021708|"~     The purpose of this study is to learn about the effects of smoking shisha on the lungs, when~     compared to the effects of smoking cigarettes or of not smoking. The investigators hope to~     learn more about how shisha smokers should be monitored and treated once diseased.~   "
79131|NCT02021695|"~     With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the~     investigators intend to measure the changes in DNA methylation and gene expression in blood~     monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are~     persistent or can be reversed by improving diabetes control.~   "
79132|NCT02021682|"~     Alzheimer's disease (AD) is the most common cause of dementia and currently has no disease~     modifying treatments or simple accurate diagnostic tests. The goal of this project is to~     study how amyloid-beta (a protein thought to cause AD) is made, transported and cleared in~     the human body. Better understanding of these processes may lead to improved understanding~     of AD, earlier diagnosis and a way to evaluate treatment.~   "
79133|NCT02021669|"~     The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is~     to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is~     superior to antidepressant therapy alone for major depression in patients with coronary~     heart disease (CHD).~   "
79134|NCT02021656|"~     This study will evaluate the antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF)~     fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with~     chronic genotype 1 Hepatitis C Virus (HCV) infection. Participants will receive 12 weeks of~     treatment and continue assessments during a 24-week follow-up period.~   "
79135|NCT02021643|"~     This study will evaluate the safety and efficacy of sofosbuvir+ribavirin (RBV), +/-~     pegylated interferon, in treatment-naive and treatment-experienced adults with chronic~     genotype 1, 2, 3 or 6 HCV infection.~      The study will be conducted in China, Hong Kong (HK), Korea, Taiwan, and Vietnam.~     Participants will be enrolled in the study for 12, 16, or 24 weeks of treatment.~   "
79136|NCT02021630|"~     This proposal is designed to examine the impact of bariatric surgery on the health of~     patients and their families. The shared environment of spouses/cohabitating partners~     suggests that patients' families are exposed to the extensive diet and lifestyle changes~     required of patients following bariatric surgery.~   "
79137|NCT02021617|"~     -  To evaluate infusion flow rates attainable when using the proximal humerus and proximal~          tibia IO vascular access sites.~        -  To evaluate the intraosseous infusion physiology when using the proximal humerus and~          proximal tibia IO infusion sites.~        -  To further evaluate the relationship between IO and venous blood when used for~          laboratory testing.~        -  To determine the time from IO needle insertion to IO access established.~   "
79138|NCT02021604|"~     Low blood sugars are known to cause brain damage in newborn babies. One of the most common~     causes of low blood sugars persisting beyond the new born period is a condition called~     congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much~     insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain~     damage. There are two forms of this disease. In one form only a small part of the pancreas~     makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin~     (diffuse HI). If a surgeon could know which part of the pancreas has the focal lesion he~     could remove it and cure the patient.~      The purpose of this study is to investigate whether a new investigational drug called~     Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon~     to remove it, thus curing the patient and preventing further brain damage~   "
79175|NCT02021123|"~     Because anidulafungin is generally well tolerated and appears to have limited interaction~     with other drugs, it is a potential important agent in the treatment of invasive fungal~     infections. Although anidulafungin is approved for the treatment of invasive candidiasis in~     adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese~     patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as~     well as other echinocandins) in this specific patient population is still largely unknown.~     During endoscopic gastric bypass surgery, patients are more prone to various kinds of~     infection, justifying the prophylactic use of anidulafungin in this specific cohort of~     patients.~      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic~     gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard~     anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be~     compared to the pharmacokinetics in a normal-weight group.~   "
79139|NCT02021591|"~     The main hypothesis of this research is that use of an informatics intervention for~     problem-solving in diabetes management, Mobile Diabetes Detective (MoDD), by individuals~     with type 2 diabetes will lead to positive improvements on a number of primary and secondary~     outcomes related to their health and their management of diabetes. The primary outcomes are~     a reduction in individuals' glycolated hemoglobin (HbA1c), improvement in their~     problem-solving abilities, and self-care behaviors. Secondary outcomes include a reduction~     in individuals' fasting blood glucose (BG); improvement in individuals' self-efficacy, and~     in emotional aspect of living with diabetes. We hypothesize that primary and secondary~     outcome effects will be sustained at three months and twelve months. Exploratory outcomes~     include a decrease in individuals' Cardiovascular Risk (Body Mass Index, Blood Pressure,~     Total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) Cholesterol levels,~     and Framingham Cardiovascular Risk Score). We also hypothesize that improvements in clinical~     outcomes (HbA1c, fasting BG and Cardiovascular Risk) will be mediated by the improvements in~     problem-solving abilities and self-efficacy.~   "
79140|NCT02021578|"~     The primary aim is to prevent depression in youth and parents in a single, integrated family~     intervention.~      Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have~     significantly fewer onsets of depressive episodes and lower levels of anxious/depressive~     symptoms as compared to children in the Written Information (WI) condition.~      Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly~     lower for those in the FDP program as compared to those in the WI condition.~   "
79141|NCT02021565|"~     The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and~     informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach~     Veterans how to safely, skillfully, and (when possible) independently perform Activities of~     Daily Living involving transfers. Experts (OTs) who provide this training will also~     recommend, provide, and install assistive technology devices such as grab bars, bed rails,~     and toileting aids as needed. Research assistants conduct home visits with the dyads pre and~     post intervention to determine the effects of the program on Veteran and caregiver quality~     of life measures (burden, depression, task efficacy, lifespace).~      Half of the couples in this study will receive the training from the expert remotely through~     a tele-video conferencing device. Research assistants will bring the device to participants'~     homes and assist in the training session.~   "
79142|NCT02021552|"~     The specific aim of this is to establish a cohort of severely injured patients admitted to~     our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from~     3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide~     polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify~     patients at highest risk for developing complicated sepsis and death.~   "
79143|NCT02021539|"~     The hypothesis tested is that the physical changes associated with cervical ripening result~     in a detectable decrease in rigidity. The main objective of this study is therefore to~     determine whether the measured elastographic rigidity of cervical tissues in addition to~     cervix size can be used to predict delivery within the next 48 hours (creation of a~     prognostic score).~   "
79144|NCT02021526|"~     This is a single-site, open-label, phase II trial of C7, a food supplement or medical food,~     for the development of treatment outcome measures for glucose transporter type I deficiency~     (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by~     changes in comprehensive blood work, including lipid and free fatty acid panels,~     self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and~     EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on~     ketogenic diet, as measured by serial ketone levels during treatment initiation.~   "
79145|NCT02021513|"~     This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus~     and lupus nephritis patients. We propose to recruit and consent SLE patients who will be~     randomized to either receive the study drug, an over the counter fish oil supplement, or a~     placebo that contains olive oil. They will have a baseline metabolomic profile (blood test),~     nutritional assessment, fatigue severity scale, quality of life assessment, and~     SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication~     distribution. Once 6 months of either the study drug or placebo is completed, then pill~     counts, assessments of experience/adherence (including side-effects, adverse effects,~     complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale,~     SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient~     will be 6 months from initiation of the study drug. It is hypothesized that patients~     receiving the fish oil supplement will have improvement in their metabolomic profile.~     Additionally it is hypothesized that patients receiving the fish oil supplement will have~     improvement in disease activity, fatigue, and quality of life assessments.~   "
79146|NCT02021500|"~     A study to collect survival data on patients previously enrolled in Abraxane pancreatic~     cancer study CA046.~   "
79147|NCT02021487|"~     The study aims to investigate the presence of a substance in the blood called prokinecitine,~     which is released by the heart when a heart attack occurs. Several venous blood samples at~     the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the~     concentration of this substance in the blood. The usefulness of this new blood marker is~     going to be determsined to seek if it would be of help to better diagnose or estimate the~     gravity of heart infarction after a heart attack.~   "
79148|NCT02021474|"~     This is a prospective multi-center, randomized, double-blind, two treatment period,~     placebo-controlled study in subjects with migraine headache requiring prophylactic~     treatment. The patients will be randomized to receive either histamine dihydrochloride sc or~     placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures~     will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks~     (week 20), 8 weeks (week 24) after the last Injection.~   "
79149|NCT02021461|"~     The purpose of this study is to investigate the taste preference in children of 3 different~     flavours of the ESL oral suspension.~   "
79150|NCT02021448|"~     Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict~     the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects~   "
82305|NCT01980082|"~     We hypothesized that revision clean head & neck surgery may have a higher rate of wound~     infection that may be lowered with prophylactic antibiotic treatment.~   "
79151|NCT02021435|"~     1. Research background~           - High blood pressure is one of the most important risk factors to cardiovascular~          diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower~          mortality effectively. Much research has proven that adjusting for Na and K intake~          level can reduce blood pressure. According to the China Salt Substitute Study, the~          systolic blood pressure of intervention group which used salt substitute is 5.4 mmHg~          lower than that of control group. Life expectancy in Tibet is 67 years old. It is~          estimated that the use of salt substitute among population in Tibet can reduce total~          mortality in Tibet by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found~          that salt substitute is effective in lowering both systolic and diastolic blood~          pressure and offers a simple, low-cost approach for hypertension control among Tibetans~          in China (unpublished results). However, the study focused on hypertensive patients,~          the effectiveness of hypertension control by providing free salt substitute to the~          entire population remains unknown, and a large-scale trial is needed.~        2. Objectives~           - Primary objective is to observe the effect of providing salt substitute on population~          blood pressure in Tibet. Secondary objective is to observe the effect of such~          intervention on population mortality, cardiovascular mortality and life expectancy. In~          addition, the data collected from high-risk population (sub-group) in the study will be~          used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and~          random blood glucose of people over 60 in Tibet will be collected.~        3. Method~             -  The study is a open, cluster-randomized, controlled trial.~             -  30 villages with 15 to 35 households each and a distance of at least five~               kilometers in between will be selected from Damxung county and Maizhokunggar~               county. The two counties have an average altitude of over 4000 meters in Tibet~               Autonomous Region.~             -  All selected villages will be randomly assigned to intervention group or control~               group on a 1:1 ratio.~             -  All household in the selected villages will be recruited if they meet the~               eligibility criteria. Approximately 4,500 participants will be enrolled~             -  Intervention group receives free salt substitute. Control group will continue to~               buy their own normal salt. Both group will receive the same health education on~               salt reduction.~        4. Outcome - Primary outcome is blood pressure. Secondary outcomes include total~          mortality, cardiovascular disease mortality, life expectancy, serum cholesterol level~          of people over 60, and random blood glucose level of people over 60.~   "
79152|NCT02021422|"~     The study's overall objectives are to evaluate the safety of anakinra in combination with~     standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as~     to collect preliminary immune modulation and clinical activity information, overall~     survival, and serious adverse events related to the study drug.~   "
79153|NCT02021409|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is~     a general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe~     and effective for the treatment of anaemia associated with chronic kidney disease.~      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.~     Participation will involve a screening visit and between 12 and 15 study visits scheduled~     over a period of approximately 5 to 7 months. The estimated total duration of study~     treatment will be 16 weeks. During these scheduled visits patients will undergo a number of~     procedures to confirm efficacy and safety of the study drug, including measurement of heart~     rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample~     collection for laboratory tests.~      The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this~     research.~   "
79154|NCT02021396|"~     The main objective is to show that splenic embolization improves salvage rate one month in a~     population of splenic trauma patients closed with a high risk of hemostasis of splenectomy~   "
79155|NCT02021383|"~     Investigators are conducting a randomized controlled trial with overweight and obese college~     students on the University of Minnesota campus. The primary outcome will be weight loss~     measured 12 months after study enrollment (corresponds to 10 months after the end of~     treatment).~   "
79156|NCT02021370|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is~     a general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe~     and effective for the treatment of anaemia associated with chronic kidney disease.~      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.~     Participation will involve a screening visit and between 12 and 14 study visits scheduled~     over a period of approximately 5 to 7 months. The estimated total duration of study~     treatment will be 16 weeks. During these scheduled visits patients will undergo a number of~     procedures to confirm efficacy and safety of the study drug, including measurement of heart~     rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample~     collection for laboratory tests.~      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this~     research.~   "
79157|NCT02021357|"~     The project aims to assess the effects of treatment proprioceptive through the use of~     hyperboloid on the intensity of pain, muscle activity, severity and joint mobility in~     subjects with TMD. Treat will be a blind randomized clinical trial. Will be recruited~     volunteers aged between 18 and 40 years, with myofascial pain and arthralgia according to~     the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly~     divided in two different groups, the first group constituted by treatment with hyperboloid~     associated with the exercise of proprioceptive tongue on the hard palate and the second~     group consists of treatment with hyperboloid. The Treatment protocols will be applied for 12~     sessions, the volunteers will be evaluated in three stages: before applying the treatment,~     immediately after the first session and after the last session~   "
79199|NCT02020772|"~     Patients who suffer from musculoskeletal pain often have more than one diagnosis. These~     patients mostly have to wait a long time for the doctor's examination and treatment, and~     they also often have a sick leave for a long period of time. The investigators expect that~     treatment and follow-up by an coordinating interdisciplinary team can improve these patients~     opportunity to function, increase their quality of life, and decrease their pain. The~     purpose of this study is to investigate if use of a coordinating interdisciplinary team in~     primary health care will result in reduced sick leave compared with practice as usual, and~     give fewer referrals to specialized health services and private rehabilitation centers.~     Research data will be obtained from the patients journals, questionnaires, and clinical~     examinations..~   "
79158|NCT02021344|"~     Most college students with mental disorders do not receive treatment, and over 80% of those~     who die by suicide have never made contact with campus mental health services. Knowledge,~     stigma, and other health beliefs represent significant barriers to help-seeking for many of~     these students. However, there have been no large-scale intervention studies for reducing~     these barriers to mental health treatment on college campuses. This project will fill this~     gap by determining whether a community mental health education program, Mental Health First~     Aid (MHFA), is an effective method to increase number of students who seek mental health~     services on college campuses. MHFA is an international, 12-hour training program that has~     been shown to increase knowledge of mental illnesses and their treatments, decrease stigma,~     and increase helping behaviors in community members. However, it has not been tested in a~     college setting in the United States. To determine the effectiveness of MHFA in US colleges,~     the proposed project will involve a randomized control trial of the MHFA training program on~     32 campuses representing a range of higher education institutions, from community colleges~     in rural areas to research universities in large, urban areas. The MHFA training program~     will be administered to peer supports such as residential advisors. Administrative data from~     campus mental health services and pre- and post-intervention surveys will be used to collect~     outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses~     will focus on identifying changes in students' behaviors, knowledge, and attitudes toward~     mental illnesses that can be attributed to the MHFA training. In addition to testing a novel~     and timely mental health intervention for college students, this project will result in~     improved data collection measures for college populations, and will lay the foundation for~     stronger connections and future collaborations between diverse campus communities. If the~     MHFA program is successful in reducing stigma and increasing general on-campus awareness and~     early treatment of emerging mental health problems, then it may provide a cost-effective~     means for enabling more students to seek early treatments for developing mental health~     problems.~   "
79159|NCT02021331|"~     The purpose of this study is to compare two different techniques of placing dental implants:~     1) removing the tooth and placing the implant immediately and 2) removing the tooth and~     placing both the implant and a temporary crown immediately. Both procedures currently are~     accepted methods for replacing missing teeth but direct comparisons of the two procedures~     are lacking. The results of this study should aid clinicians in selecting the best implant~     placement technique for their patients.~   "
79160|NCT02021318|"~     This study is conducted to explore a new therapy for anemia in patients with chronic kidney~     disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which~     contains iron) is important for the transport of oxygen in your blood. The purpose of the~     study is to see if Roxadustat is effective and safe to treat anemia in patients with chronic~     kidney disease. Roxadustat will in this study be compared to darbepoetin alfa, a~     commercially available medicine for treatment of anemia (tradename Aranesp).~   "
79161|NCT02021305|"~     Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the~     patients, associated with urinary track infections. In this study the researchers will try~     to investigate the role of TLRs as molecular interactions between bacterial virulence and~     host response.~      TLRs are important mediators in the development of the natural immunity against bacteria.~     They recognize microbial pathogen associated molecular patterns and alert the host's immune~     system to the presence of invading microbes~   "
79162|NCT02021292|"~     Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for~     treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).~   "
79163|NCT02021279|"~     The primary objective of this study is to assess the safety and effectiveness of MatriStem~     Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ~     prolapse. Patients are evaluated throughout a 3 year follow-up period.~   "
79164|NCT02021266|"~     This is a single patient expanded access protocol to investigate the effects of a second~     dose of facilitating cell-enhanced hematopoietic stem cell product.~   "
79165|NCT02021253|"~     Surgical resection is one of the curative treatment modalities for HCC. Limits are~     postoperative septic and liver functional complications related to an increase in bacterial~     translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and~     bacterial degradation products from the intestine to the portal circulation. The endotoxemia~     secondary to bacterial translocation, stimulates endothelial production of nitric oxide~     (NO). NO is also a potent inducer of membrane instability, responsible for an increase in~     the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to~     a worsening of bacterial translocation.~      Probiotics are live microorganisms which when administered in adequate amounts, provide a~     health benefit on the host ((Health and Nutritional Properties of Probiotics in Food~     Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data~     from experimental and clinical literature show a significant effect of probiotics on the~     improvement of liver function and a decrease in infectious complications in patients with~     chronic liver disease. The proposed study would evaluate the effect preventive and~     therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic~     inflammation promotes postoperative complications.~   "
79166|NCT02021240|"~     Low dose sub-anaesthetic dose of ketamine has been shown to reduce postoperative pain and~     analgesic consumption. However, due to the heterogeneous results, the standard dosing~     regimen has not been available. Recently, its effect in postoperative outcomes and the~     development of post-operative surgical pain has also been suggested.~      Ketamine has been shown to reduce post-operative early inflammation especially serum IL-6.~     Therefore, study in its effects in post- operative pain and outcomes due to inflammation is~     suggested. Only few clinical studies assessed post-operative pain are related to~     inflammation.~      Pain after third molar surgery is a good model of postoperative acute inflammatory pain.~      A previous study showed that there was no benefit to administer ketamine before or after~     oral surgery for pain relief. However, other studies demonstrated that ketamine used as~     sedative or local ketamine in third molar surgery could reduce postoperative dental pain,~     swelling and trismus.~      Postsurgical facial oedema is difficult to quantify accurately as it is three dimensional.~     Over the years, various measurement techniques have been tried to measure oedema~     objectively. These include direct linear measurement using tape or flexible rulers across~     fixed soft tissue landmarks, standardized stereophotographic measurements, computerized~     tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and three -~     dimensional (3D) laser scanning. Recently, three dimensional image reconstructions using a~     reversed engineering technique has been developed and is used in the manufacturing industry.~     This technology could be applied in a clinical setting for monitoring soft tissue changes.~      In this study, the investigators will aim to study the use of sub-anaesthetic dose of~     ketamine in post-operative dental pain and recovery outcomes.~      The investigators hypothesise that post-operative pain after Bilateral Third Molar under~     General Anaesthesia is less in patients receiving sub-anaesthetic does of ketamine before~     incision. The magnitude of this effect will be compared with a positive control group~     (dexamethasone) as well as a placebo group (normal saline). Further, the investigators aim~     to demonstrate whether ketamine can reduce post-operative facial oedema and other~     post-operative outcomes.~   "
79200|NCT02020759|"~     Neurological complications are frequent during extracorporeal membrane oxygenation (ECMO)~     representing a crucial factor for patient outcome. However, to date there is no consensus~     with regard to optimal neurological monitoring of patients undergoing ECMO.~      The aim of this study is to monitor patients using transcranial Doppler (TCD) ultrasound and~     near-infrared spectroscopy (NIRS) during ECMO therapy.~      The study hypothesis is that TCD and NIRS technology are sufficient tools to detect cerebral~     embolism and hypoperfusion during ECMO therapy.~   "
82306|NCT01980069|"~     Investigators hypothesized that the surgical condition will be improved with the use of~     sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the~     effect of sugammadex and neostigmine on the surgical condition during laryngeal~     microsurgery.~   "
79167|NCT02021227|"~     The occurrence of an acute respiratory failure necessitates mostly admission to ICU and~     mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective~     for the majority of patients. Many reasons may contribute to weaning , extubation failure~     and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged~     MV, may represent a main factor and early rehabilitation may reverse these conditions and~     improve the success of weaning from MV.The objective of this study is to evaluate the effect~     of an early chair sitting (while the patient is awake but still mechanically ventilated) on~     weaning from mechanical ventilation and ICU mortality.~      Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV~     for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule:~     the studied group (20 patients): chair-sitting group will be transferred from bed to arm~     chair for at least 1 hour and once a day; the control group will stay in bed until~     extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality,~     ICU length of stay are assessed and compared between groups. Expected results: Early chair~     sitting would decrease MV duration, number of extubation failure, nosocomial infections and~     ICU mortality. Feasibility and safety of this intervention will also be evaluated and also~     the related work load.~   "
79168|NCT02021214|"~     In the present study, investigator will investigate the effects of methylphenidate (40 mg)~     on mPFC activity in healthy male volunteers during fear extinction using functional magnetic~     resonance imaging (fMRI). Additionally, investigators will examine the effects of~     methylphenidate during aversive interoceptve arousal. The present study will help to~     identify brain structures and networks involved in anxiety and will give insights for~     methylphenidate as a possible adjunct to behavioral therapy for patients with anxiety~     disorders. Further, this study may provide important information about the possible use of~     fMRI to help the development of drugs for the treatment of anxiety disorders.~   "
79169|NCT02021201|"~     This comparison is made between the effects of sertindole and risperidone on vulnerability~     indicators in schizophrenia. More specifically: the effects of these two antipsychotic~     compounds on basic processing of incoming information is studied. The investigators expect~     that the newer antipsychotic sertindole to be more effective in restoring information~     processing in schizophrenia patients than risperidone.~   "
79170|NCT02021188|"~     This VISION study aims to investigate the role of inflammation in atherosclerosis using~     68Ga- DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and~     quantification of vascular inflammation in the aorta, coronary and carotid arteries. This~     study will test the hypothesis that in subjects undergoing carotid endarterectomy for~     symptomatic plaques, there will be a positive correlation between carotid artery~     68Ga-DOTATATE PET signal and the underlying degree of carotid inflammation measured by~     immunohistochemical analysis.~   "
79171|NCT02021175|"~     Cigarette smoking remains the leading preventable cause of morbidity and mortality in the~     United States. In Los Angeles, rates of morbidities due to cigarette smoking follow~     prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at~     historic lows, prevalence is not uniform: Cigarette smoking is pervasive among residents who~     have significant economic disparities. Prevalence is also among the highest in the world for~     Korean school-aged youth and substantially higher numbers of Korean American youth smoke~     cigarettes. To date, smoking prevention efforts in Korea have had mixed results as they are~     not interesting to youth and are not interactive.~      This project will assess an interactive, culturally adapted, tailored smoking cessation~     intervention delivered through the internet and cell phone. Using technology, the~     investigators seek to increase the reach and access of our intervention and facilitate~     cessation without in-person sessions, a factor that limits smoking cessation interventions~     for youth. Youth are energetic users of electronic media, lending support to the delivery of~     treatment through technology.~      The investigators predict that subjects assigned to the intervention will demonstrate~     statistically higher rates of smoking abstinence and longer retention in the cessation~     program compared to those assigned to the standard of care condition. Subjects reporting~     higher levels of smoking exposure, lower motivation, poor mental health, disadvantaged~     neighborhoods, and lower levels of acculturation to American culture will also have lower~     quit rates at each follow-up visit.~   "
79172|NCT02021162|"~     This study aims to assess the effect of Gilenya on brain pathology and cognitive impairment~     over 6, 12, and 24 months in patients with relapsing MS using MRI, clinical data, and~     neurological assessments. Healthy controls will also be followed over 6, 12, and 24 months~     using the same measures.~   "
79173|NCT02021149|"~     According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9~     million American adults, or 9.5 percent of the population over the age of 18 suffer from~     mood disorders including major depressive disorder, chronic, mild depression and bipolar~     disorder. Major depressive disorder (MDD) is predicted to be the second leading cause of~     disability worldwide by the year 2020; sub-clinical mood disturbances impact many additional~     people and are a major reason people seek psychotherapy services. The economic burden of~     depression in the United States is significant: $83.1 billion in 2000 and increasing. Much~     of this burden comes from the high rate of sub-optimal treatment outcomes associated with~     the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate~     treatment, and up to 20% of patients will fail to adequately respond to all currently~     available interventions. Moreover, current treatments come at the cost of significant~     central nervous system (CNS) side effects, further highlighting the need for more effective~     treatments with fewer side effects. To address these pressing clinical issues, the~     investigators will conduct a placebo controlled, clinical trial to determine if Whole Body~     Hyperthermia (WBH) enhances the effects of psychotherapy compared to psychotherapy alone in~     medically healthy patients with moderate to severe mood disorders. The investigators plan to~     recruit a sample of 24 medically healthy individuals with mood problems who will be~     randomized to examine whether WBH enhances the effects of psychotherapy. To determine acute~     and sustained effects of WBH +psychotherapy on mood disorders, the study will include basic~     psychiatric questionnaire-based assessments at three therapy sessions prior to a single~     session conducted while receiving one of two intensities of WBH treatment. Subjects who~     elect not to conduct a therapy session in the WBH chamber will still be able to complete~     study questionnaires at all therapy sessions. This study challenges the existing paradigm by~     determining if peripheral afferent sensory pathways can be accessed to enhance the treatment~     of mood disorders and thus avoid problems of exposing all of the brain to non-selective~     drugs.~   "
79174|NCT02021136|"~     The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace +~     standard treatment versus standard treatment alone in terms of last 24-hour pain relief~     after 6 weeks. in patients with medial knee osteoarthritis.~   "
80042|NCT02009748|"~     Previous studies suggested that vitamin D deficiency is highly prevalent in cirrhotic~     patients and is related to the degree of liver dysfunction as well as mortality. In~     gastrointestinal disorders, vitamin D absorption can be highly reduced.~      We herein aim to investigate the efficacy of oral vitamin D supplementation in cirrhotic~     patients with vitamin D insufficiency.~   "
79176|NCT02021110|"~     Rationale: Polycystic liver disease (PLD) is a rare disorder characterized by >20~     fluid-filled hepatic cysts. Polycystic livers are present in the combination with renal~     cysts as a manifestation of autosomal dominant polycystic kidney disease (ADPKD), or~     isolated in the absence of renal cysts as autosomal dominant polycystic liver disease (ADPLD~     or PCLD). PLD patients are confronted with symptoms caused by the mass effect of their~     polycystic liver every day for the rest of their life. There is no standard therapeutic~     option for symptomatic PLD patients. Current options are fairly invasive or their efficacy~     is only moderate.~      Preliminary data in our research lab have shown that ursodeoxycholic acid (UDCA) inhibited~     the proliferation of polycystic human cholangiocytes in vitro through the normalization of~     the intracellular calcium levels in cystic cholangiocytes. The investigators also found that~     daily oral administration of UDCA for 5 months to PCK rats, an animal model of ARPKD that~     spontaneously develops hepato-renal cystogenesis, resulted in inhibition of hepatic~     cystogenesis.~      The investigators hypothesize that UDCA is an effective therapeutic tool in reducing liver~     volume in PLD.~      Objective: First, to demonstrate whether UDCA-therapy is effective in reducing total liver~     volume in PLD patients. Second, the investigators want to assess if UDCA modifies quality of~     life. Finally, the investigators want to assess safety and tolerability.~      Study design: International, multicenter, randomized, controlled trial Study population: 34~     subjects (18 ≤age ≤ 80 years) suffering from symptomatic polycystic liver disease with~     underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts on CT-scan and liver~     volume of ≥ 2500. Symptomatic is defined as ECOG-PS ≥ 1 and having at least three out of ten~     PLD symptoms.~      Intervention: The patients will be randomized (1:1) into two groups. One group of patients~     will receive 15-20mg/kg/day UDCA for 24 weeks. The other group will receive standard care.~      Main study endpoint: Proportional change of total liver volume in UDCA treated patients~     versus non treated patients, as assessed by CT at baseline and 6 months.~      Main secondary outcome variables:~        -  To demonstrate whether UDCA-therapy changes absolute total liver volume~        -  To demonstrate whether UDCA-therapy changes gastro-intestinal symptoms measured by a~          GI-questionnaire~        -  To demonstrate whether UDCA-therapy changes quality of life as measured by SF-36~        -  To demonstrate which proportion of patients has any reduction in total liver volume~          after 24 weeks~        -  To demonstrate whether UDCA is well tolerated~        -  To demonstrate whether UDCA-therapy changes absolute total kidney volume (TKV).~   "
79177|NCT02021097|"~     The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral~     contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30~     mcg.~   "
79178|NCT02021084|"~     Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ),~     some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse~     effect such as diarrhea and abdominal pain especially in the higher dose.~      5-10% of the patients with FMF that have been treated with colchicine may have partial or no~     response to this therapy.~      Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in~     reducing the number of adverse effect in patients with FMF that are being treated with~     colchicine and suffering from GIT adverse effect.~      .2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children~     with FMF that has been treated with colchicine with only partial response.~      Methods: the study will be done among children (5-17 years old) with FMF that are currently~     followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that~     are being treated with colchicine and suffering from either GIT adverse effect or partial~     response to colchicine.~      The study is design to be double blind placebo control, in the first 3 month patients will~     be with no therapy and will be required to record all there FMF episodes and their GIT~     adverse effect, in the second period the patients will be randomly divided into two groups~     1.patients that will received placebo (group 1) and the 2. Probiotics group - patients will~     received probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum ,~     L.rhamnosus, L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum,~     B.infantis), both for three month, during this period patient will be required to record~     their gastrointestinal symptoms and other symptoms that may be related to FMF.~   "
79179|NCT02021071|"~     Philips Healthcare has added a virtual path planner to the current commercially available~     XperGuide software platform and that has the potential to significantly reduce dose during~     image-guided needle interventions.~   "
79180|NCT02021058|"~     Multinational, multicenter, clinical trial. To evaluate the effect of an experimental~     formula on GI symptoms and associated behaviors in unsettled infants with parent-reported~     feeding intolerance~   "
79181|NCT02021045|"~     There is increasing evidence that renal replacement therapy (= continuous veno-venous~     hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler~     ultrasound.~      The aim of this study is to monitor patients with transcranial Doppler under two conditions:~     during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic~     load is detected during 30 minutes).~      The study hypothesis is that during hemodialysis the cerebral embolic load is significantly~     higher than in the hemodialysis-free interval.~   "
79182|NCT02021032|"~     The primary objective of the post-marketing study is to collect safety and effectiveness~     data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety~     information will be used to evaluate the occurrence of any long-term side effects from the~     treatment. The collection of long-term effectiveness data on subjects treated with Prolieve®~     will provide information on the long-term effects of treatment and time to re- treatment~     (any treatment initiated for BPH since Prolieve' treatment, including a second treatment~     with Prolieve).~   "
79183|NCT02020980|"~     The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections~     in relieving pain, in a broad population of patients who suffer pain as the primary problem~     associated with spasticity. Thus, this study will help to expand the information that is~     available regarding the impact of BoNT-A treatment in routine clinical practice conditions.~      Treatment goals can vary greatly from one patient to another and there is no unique, single~     outcome that reflects the treatment benefits in all the cases. Therefore, this study with~     special focus on the achievement of therapeutic goals, will allow the identification of each~     patient's specific goals regarding the improvement of the functional outcomes, the quality~     of life and patient well-being.~   "
79184|NCT02020967|"~     The primary objective of the protocol is to define percentage of patients with acromegaly in~     relation to the total number of screened patients with confirmed clinically significant set~     of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I,~     Growth Hormone, Oral Glucose-Tolerance Test [IGF-1, GH, OGTT]) and instrumental examination~     methods (Magnetic Resonance Imaging [MRI]).~   "
79185|NCT02020954|"~     The purpose of this study is to determine whether electrocardiogram, echocardiography,~     cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and~     clinical outcome.~   "
79186|NCT02020941|"~     This phase II trial studies how well carfilzomib works in treating patients with multiple~     myeloma in first relapse or refractory to first-line therapy. Carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
85214|NCT01942044|"~     The purpose of this study is to evaluate the differences of wall shear stress distribution~     among different types of drug-eluting stents and its impact on vessel healing evaluated by~     intravascular optical coherence tomography evaluation.~   "
79187|NCT02020928|"~     Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often~     at increased risk for infections and even the interruption of treatment, interfering with~     the prognosis of the disease. The low intensity laser therapy has been proposed as an~     alternative for the treatment and prevention of this side effect, with good results in terms~     of clinical and functional, speeding up the process of wound healing and reducing pain.~      Objective: To evaluate the effectiveness of using low power laser in the prevention of oral~     mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow~     transplantation.~      Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the~     effectiveness of using low power laser in the prevention of oral mucositis in patients with~     hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate~     in the study, patients who are in the condition mentioned above accepting participate and~     have aged over 18. Will be excluded from the study patients who have autoimmune disease,~     which present sensitivity to laser or who have already started treatment for oral mucositis~     prior to this study.The study variables are:-independent variable: whether or not the red~     laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy~     regimen, type of blood cancer. For determining the association between the independent~     variable and the dependent will be used chi-square tests of association (Pearson) and~     Fisher's exact test, if necessary. Will calculate the risk ratio (RR) as a measure of~     relative risk, with the confidence interval at 95% (IC95%).Also be calculated NNT (number~     needed to treat to obtain benefit) and NNH (number needed to harm getting). Will be adopted~     a significance level of 5%. The project was approved by the Ethics and Research iMIP. All~     patients will be appropriately informed about the objectives of the project and will only be~     included if they voluntarily agree to participate by signing the consent form.~      Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.~   "
79188|NCT02020915|"~     Ultrasound guided placement of the knife intersphincteric increases accuracy and safety~     during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter~     is divided.~   "
79189|NCT02020902|"~     This is a post-marketing surveillance study on a marketed cetrizine hydrochloride~     formulation.~   "
79190|NCT02020889|"~     The purpose of this randomized, double-blind study is to investigate the efficacy and safety~     of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared~     with placebo over a 52-week study treatment period in subjects with relapsing or refractory~     Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy~     including background corticosteroid therapy with or without immunosuppressive therapy.~     During the treatment period, in accordance with standard of care, corticosteroid dose will~     be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined~     as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day~     prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid~     requirement.~   "
79191|NCT02020876|"~     This clinical utility study pilot is based on a review of real but de-identified and~     randomized patient cases and aims to evaluate Urologists' treatment recommendations before~     and after reviewing the results provided by the Decipher test. This is a pilot study and the~     primary intent is to help guide development and design of future clinical utility studies~     for Decipher~   "
79192|NCT02020863|"~     The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid~     administration system to deliver fluids using feedback from standard operating room~     hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the~     patient is determined by the anesthesiologist caring for the patient. In this study~     protocol, the rate of fluid administration will be determined instead by the closed-loop~     (automated) control system under the supervision of the anesthesiologist. The system will~     independently decide when to give fluid and at what rate; the supervising anesthesiologist~     will monitor the system to ensure appropriate volumes are being delivered and to intervene~     if necessary.~   "
79193|NCT02020850|"~     The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average~     value we measured in normal individuals is about 1.0, furthermore, we can not find out the~     reference of TBI that is currently being used. The purpose of this study is to determine the~     more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants~     will be required to fill out a demographic questionnaire before the blood pressures test.~     All participants will have their toe, ankle and brachial systolic blood pressure~     measurements to obtain the TBI and ABI.~   "
79194|NCT02020837|"~     This study will assess the impact of lymphaticovenous microanastomosis in volume reduction~     of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous~     micro-anastomosis in the distal arm will result in the reduction of volume and improvement~     in quality of life of patients with post-mastectomy lymphedema~   "
79195|NCT02020824|"~     Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia~     or acrophobia, since it permits to have a better control (on occurrence of events or on the~     environment) during the therapy than in in vivo therapy. Our hypothesis here is that we~     can improves the therapeutic effects of the virtual exposure by giving control to acrophobic~     patients during their exposure.~   "
79196|NCT02020811|"~     The study will evaluate the functionality of IMMAGES , an intravenous infusion device~     system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how~     the IMMAGES system integrates within IV infusion therapy regime and what are the advantages~     and disadvantages, if any, of using this system within the prescribed setting.~   "
79197|NCT02020798|"~     The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.~   "
79198|NCT02020785|"~     Phosphorus-based food additives are commonly used by food manufacturers for many~     applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these~     additives can significantly increase an individual's daily phosphorus intake, little is~     known about the effect of dietary phosphorus on kidney health. In this study, the~     investigators will first lower baseline phosphorus intake to about 1000mg/d by educating~     participants to avoid foods with phosphorus additives. Then, participants will be randomized~     to a higher phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing~     unaltered, commercially-available food/beverage products with and without phosphorus~     additives.~      The investigators hypothesize that participants will have higher urine albumin excretion and~     fibroblast growth factor-23 during the higher phosphorus period compared to the lower~     phosphorus period.~   "
79236|NCT02020278|"~     The objective of this trial is to provide 6 months of safety follow-up for children and~     adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who have previously~     participated in a tolvaptan hyponatremia trial, and to assess the efficacy of tolvaptan in~     increasing serum sodium for those subjects who receive optional continuing tolvaptan~     treatment of variable duration (up to 6 months).~   "
86257|NCT01928342|"~     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in~     Chinese patients with moderate dyslipidemia.~   "
79201|NCT02020746|"~     The main objective of this study is to assess the safety and the efficacy of EscharEx in~     preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower~     extremity ulcers and traumatic/post operative wounds.~      This study will be a multi-center, assessor blinded, randomized, controlled study intended~     to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control~     treatment in patients with hard to heal wounds.~      72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound~     (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound)~     between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be~     enrolled into the study.~      Patients will undergo a 1 week screening period (2 visits) which will include: record of~     demographics, medical history and concomitant medications, vital signs, physical~     examination, clinical laboratory tests, wound photography and assessments and questionnaires~     (wound status and quality of life). During this period wounds will be treated by standard~     treatment per the decision of the physician. During this screening period, subjects whose~     study wound size (surface area) decreases by more than 20 percent will be excluded.~     Following completion of the screening process, eligible patients will be randomized to~     either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment~     will be performed for up to 10 applications or until complete debridement is achieved,~     whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8~     applications or until complete debridement is achieved, whichever occurs first. Following~     each application the wound will be washed, photographed and assessed for wound size, removal~     of nonviable tissue and change in granulation tissue (by digital planimetry software), wound~     status, and safety parameters. Subsequent to each debridement treatment the wound will be~     dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are~     performed, in the second stage). Following completion of the debridement treatment period,~     patients will be treated according to standard procedures and evaluated (wound assessments)~     once a week until complete wound closure for up to 12 weeks from last application (up to 12~     visits). Only during the first stage of the study, for patients who achieved wound closure,~     additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be~     conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months~     post wound closure follow-up period. For patients who didn't achieve wound closure only the~     3 months FU visit will be conducted. For patients enrolled at the second stage, if wound~     closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks~     later to confirm wound closure.~   "
79202|NCT02020733|"~     The aim of this study is to compare the metal cannula routinely used in our clinical~     practice with intrauterine hysterosalpingography catheter as a probable alternative device~     in a prospective, single-blinded, randomized study.~   "
79203|NCT02020720|"~     This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission~     tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such~     as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.~   "
79204|NCT02020707|"~     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized~     nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that~     cannot be removed by surgery or with cancer of the cervix, endometrium, ovary, fallopian~     tube or peritoneal cavity. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by~     targeting certain cells. Giving paclitaxel albumin-stabilized nanoparticle formulation and~     bevacizumab may kill more tumor cells.~   "
79205|NCT02020694|"~     Hypovitaminosis D is highly prevalent in the general population, particularly in obese~     individuals. Besides being associated with obesity, vitamin D deficiency seems to be~     involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In~     addition, it has been reported that individuals with low vitamin D levels are at increased~     risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the~     prevention of cardiovascular diseases. Vitamin D supplementation could increase the~     beneficial effects of these lifestyle interventions. The purpose of this study is to assess~     whether vitamin D supplementation in conjunction with a hypocaloric diet improves the~     cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.~   "
79206|NCT02020681|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early buccal carious lesions compared to placebo.~   "
79207|NCT02020668|"~     Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared~     almost exclusively toward medical-pharmacological area away from offering the patient the~     possibility of an interdisciplinary approach to their disease.~      Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in~     rheumatic disease and improve their quality of life related to health.~   "
79208|NCT02020655|"~     Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin~     and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas~     exposed to pressure, shear and friction. Shear- force is an important contributing factor~     and wound dressing are possibly capable to reduce shear force at the skin. At this moment~     there's no good marker to detect the effect of shear- force at the skin. A potential marker~     could be cytokines (IL-1α) which are released after mechanical loading of the skin. A~     previous study have shown a significant increased level of IL-1α after the application of~     pressure. We want to investigate if these cytokines are significant increased after the~     application of shear- force at the skin.~      Objective: The objective of this study is to gather knowledge about cytokine concentrations~     (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to~     use this knowledge in the future to investigate if different prophylactic wound dressings~     are capable to reduce shear force at the skin. This could be interesting in the prevention~     of pressure ulcers.~      Study design: With the use of a special developed shear- force model are we going to~     administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy~     volunteers for 30 minutes. As a control we ware going to put the shear- force model at the~     other arm without the application of shear- force. Before the use of the shear- force model~     we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to~     absorb cytokines from the skin. After the use of the shear force- model we will perform~     cytokine measurements again. Then we will extract the cytokines from the Sebutape with the~     use of ELISA.~      Study population: 10 Healthy volunteers Age 18- 30 years~      Primary outcome: IL-1 α concentration (pg/ml)~   "
79209|NCT02020642|"~     The purpose of this study is to investigate the effect of renal transplantation on fluid~     overload and its consequence on the severity of obstructive sleep apnea, in patients with~     end stage chronic kidney disease. It aims further to investigate the relationship between~     overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.~   "
79210|NCT02020629|"~     In hypoglycemia, there is a counterregulation to restore glucose levels. An important part~     of this counterregulation is the release of the hormone glucagon. Since the GLP-1 receptor~     agonist lixisenatide has been shown to be associated with a low risk of hypoglycemia, this~     study examines whether lixisenatide affects the glucagon response to hypoglycemia.~   "
79211|NCT02020616|"~     The purpose of this study is to investigate the safety and effectiveness of the study drug~     known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be~     given in different doses as an injection under the skin. The study is expected to last up to~     6 months for each participant. Participants may remain on stable-dose metformin as~     prescribed by their personal physician.~   "
79212|NCT02020603|"~     Endoscopic high-frequency soft coagulation is available for the management of bleeding or~     nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy~     on peptic ulcer bleeding has not been elucidated so far. The aim of this study was to~     evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by~     comparing it with argon plasma coagulation (APC) in a prospective, randomized trial.~   "
79213|NCT02020590|"~     Fracture healing is a complex physiological process caused by interaction of cellular~     elements, cytokines and signaling proteins, which results in the formation of new bone.~     There is for now no universally accepted approach to evaluate the progression of fracture~     healing. Typically, a fracture is considered as a delayed-union when the bone has not united~     within a period of time that would be considered adequate for bone healing. Delayed-union~     suggests that union is slow but will eventually occur without additional surgical or~     non-surgical intervention, whereas non-union is defined as the cessation of all reparative~     process of healing.~      The incidence of impaired healing is estimated to range from 5 to 10% of all long bone~     fractures, depending on the fracture site, the type and degree of injury, among other~     factors. Currently the treatment of choice remains bone allograft or autograft. This~     procedure shows in general good results but requires an invasive surgery of several hours~     under general anesthesia, followed by a few days of hospitalization. Because of this, major~     complications have been reported in up to 20-30% of patients.~      The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union~     fractures of long bones. In this study, delayed-union is defined at the time of screening as~     a slow progression or an absence of healing of minimum 3 months after the onset of the~     fracture.~   "
79214|NCT02020577|"~     The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of~     dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will~     involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous~     histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced~     solid tumours (except sarcomas).~   "
79215|NCT02020564|"~     The purpose of this research study is to investigate the effectiveness of a technique~     designed to improve processing speed (i.e. the amount of time it takes to process~     information) in a Traumatic Brain Injury (TBI) population. The study is designed to study~     how well this technique can help people with TBI increase their processing speed and their~     ability to function better in everyday life.~   "
79216|NCT02020551|"~     Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol~     and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested~     whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.~   "
79217|NCT02020538|"~     This primary aim of this study is to test the impact of a strategy of perioperative~     chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney~     injury after cardiac surgery.~      A prospective, open-label, single-centre 4-period sequential study of varying strategies of~     perioperative IV fluid composition will test the hypothesis that a perioperative protocol~     for the administration of chloride-poor intravenous fluids compared to chloride-rich~     intravenous fluids will reduce the incidence of AKI after adult cardiothoracic surgery.~   "
79218|NCT02020525|"~     -  We have previously reported the results of the primary and secondary outcomes of a~          randomized study aiming to investigate the impact of a restrictive transfusion protocol~          on the magnitude of reduction in blood transfusion in a typically mixed general surgery~          population subjected to major abdominal surgery.~        -  The main finding of that study was a reduction in red blood cell usage with the~          implementation of a restrictive transfusion regimen. This was achieved without~          adversely affecting clinical outcome in the population studied.~        -  The aim of this secondary analysis performed on a subgroup of 20 patients from the~          original study was to determine whether there are any differences in the postoperative~          immunologic response, as expressed by the production of inflammatory mediators, between~          a restrictive approach to red cell transfusion and a more liberal strategy.~   "
79219|NCT02020512|"~     This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma~     and ocular hypertension.~   "
79220|NCT02020499|"~     This is a long term study to evaluate common therapeutic algorithms and possible predictive~     parameters for Somatuline Autogel treatment in patients with Acromegaly.~   "
79221|NCT02020486|"~     This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The~     Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be~     admitted to the clinical study ward the day before starting the study drug administration~     (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33~     (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group~     A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240~     mL of room temperature water~   "
79222|NCT02020473|"~     End-of- life care is a major issue in medical ethics with life support technology progress.~     Intensive care may prolong the dying process in patients who have been unresponsive to the~     treatment already provided. Withholding or withdrawing of life support (WLS) care was~     introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult~     and affected by several factors including not only disease severity but also ethics,~     religion, culture, and legal background. In western countries, advance directives had an~     important role to WLS for dying patients and honor patient autonomy. However, the illegality~     of advance directives in Korea and Korean culture under Confucianism, requiring children to~     do the best to treat their parents in the name of filial piety make physicians and family~     members difficult to WLS in terminally ill patients.~      Additionally, WLS in intensive care unit had been usually decided without official~     documentation before the final legal decision by Supreme Court in Korea. Scanty information~     exists about end-of-life practices because informed consents of WLS were taken after the~     legal decision.~      Thus, we aimed to investigate the current status of informed consent at the time of decision~     to WLS and difference between WLS group and non-WLS group in Korea.~   "
79223|NCT02020460|"~     The study will examine the feasibility of Direct Dorsal Column Stimulation using existing~     Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory~     evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and~     use of pain medications.~   "
79224|NCT02020434|"~     RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem~     (RPX2014)to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
86258|NCT01928329|"~     The goal of the proposed pilot study is to determine whether glucose control can be improved~     with Bydureon treatment in patients with type I diabetes (T1D)~   "
79225|NCT02020421|"~     The current standard of care for rehabilitation of patients with aphasia after stroke is~     conventional speech and language therapy (SLT). Due to economic realities on most stroke~     units, SLT can often not be given with optimal intensity in the first weeks after the~     stroke. Developing new adjuvant therapies which may render SLT sessions more effective is~     thus one approach to improve rehabilitation outcome. Recent functional imaging studies in~     post-stroke aphasia have shown that the recruitment of brain regions in the unaffected~     hemisphere seems to be an inferior strategy for recovery of language function as compared to~     re-activation of brain regions in the vicinity of the infarct. Non-invasive brain~     stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) or~     transcranial direct current stimulation (tDCS) are new methods to modulate brain activity.~     Evidence from our own feasibility study in sub-acute stroke suggests that these new~     techniques, when applied in conjunction with conventional SLT, may help to normalize brain~     activation patterns and might yield better rehabilitation outcome than SLT alone. With~     NORTHSTAR, we propose a multicenter proof-of-concept study to investigate the safety,~     feasibility and efficacy of these new non-invasive brain stimulation methods as adjuvant~     therapies for subacute post-stroke aphasia.~      Our goal is to determine the most effective brain stimulation modality to decrease~     inhibition onto the left side of the brain. We will assess if a combination of brain~     stimulation and speech and language therapy will improve language recovery. We will quantify~     language recovery (expressive and comprehensive skills) using specific tests, commonly used~     by speech and language therapists.~      We will invite patients recently admitted to the stroke unit of the study centers to~     participate in our research project. Once patients consent to our study we will randomly~     assign them to one of three experimental groups. For 12 days, all groups of patients will be~     setup with brain stimulation during their usual rehabilitation sessions. Two of those groups~     (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS),~     in the third group, patients will not receive real stimulation (placebo group). By comparing~     the extent of aphasia recovery between groups, we will determine the benefits attributable~     to brain stimulation relative to SLT alone.~   "
79226|NCT02020408|"~     This study will use brain imaging technologies to measure several neurotransmitters~     (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit~     our impulses, and which are known to be altered in the brain of people with anorexia nervosa~     (AN) and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we~     propose to use a challenge with brain imaging that will stimulate dopamine release which we~     hypothesize will generate anxiety rather than pleasure in AN, and will help explain why AN~     restrict eating in order to reduce anxiety. This study will help to understand the unique~     puzzling symptoms in eating disorders and contribute to finding better methods for~     identifying effective treatments for these often relapsing and sometimes chronic disorders.~   "
79227|NCT02020395|"~     The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like~     peptide (GLP)-1 responses to a test meal in lean and obese individuals.~   "
79228|NCT02020382|"~     The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon~     (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and~     non-IBD colitis)~   "
79229|NCT02020369|"~     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2~     separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for~     the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor~     VIII/IX~   "
79230|NCT02020356|"~     The primary purpose of the protocol is to demonstrate that the use of music therapy may make~     it possible to discontinue at least one of neuroleptic treatment in patients with AD or~     related symptoms complicated by behavioral disorders such as agitation and aggressiveness~     evaluated using the Neuropsychiatric Inventory (NPI).~      The study hypothesis is that music therapy may have a positive impact on patients with AD~     complicated by behavioral disorders by reducing the intensity of oppositional behaviour and~     aggressiveness and allowing a diminution of neuroleptic treatment.~   "
79231|NCT02020343|"~     America's preferential consumption of high-fat/high-sugar foods is a driving force in the~     current epidemic of obesity and insulin resistance. Recent scientific observations suggest~     that the taste of food may play a role in how the body processes the food eaten in a meal.~     The intestine may play a central role in all aspects of dietary fat metabolism, from initial~     encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body.~      The investigators hypothesize that elevated blood fats in insulin resistance are a result of~     elevated intestinal-TG secretion and poor communication of this organ to the rest of the~     body after meals.~      In this study, meal feeding and sensory studies will be performed to determine whether the~     mechanism of taste-associated intestinal signaling leads to higher levels of blood fats~     after meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will~     consume special meals the night before the tests and participate in sensory tests in the~     morning to analyze the effect of taste.~      The goal of this work is to understand how insulin resistance may cause impaired signaling~     between the taste buds and the intestine to result in an elevation in blood lipids, which~     increases the risk for other chronic diseases. This study will generate data for a future~     study to understand how diabetes treatment affects this process.~   "
79232|NCT02020330|"~     This is a randomised two arm study, comparing artemether-lumefantrine 3 days and 5 days~     treatment. Patients will be randomised in blocks of ten to one of the two treatment arms.~     The standard regimen is twice daily for three days with a delay of at least eight hours~     between the first and second doses. A single of primaquine will be given to all patients on~     the first day of treatment for gametocytocidal activity. The initial treatment will be given~     under supervision, all other subsequent doses will be given to the patient to the taken at~     home. Patients will be followed up for nine visits over forty two days.~   "
79233|NCT02020317|"~     To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia~     alerts during potassium-increasing drug-drug-interactions.~   "
79234|NCT02020304|"~     The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have~     a shorter period of pain relief than that maintained at room temperature. The temperature of~     the dose of medication will be measure with an infrared thermometer immediately prior~     (within 5 minutes) to administration.~   "
79235|NCT02020291|"~     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role~     in the formation and dissemination of tumours. The present project focuses on the critical~     role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer~     disease.~      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which~     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby~     acting anti-metastatic. The aim of the present clinical phase 1 trial is to establish the~     recommended dose for a clinical phase 2 study and thereby further develop Foxy-5 as a first~     in class anti-metastatic cancer drug. Foxy-5 is designed to inhibit the development of~     metastasis by reducing the motility of cancer cells and should thereby increase the survival~     rates of patients with solid malignant tumours.~   "
79239|NCT02020239|"~     The investigators goal is to optimise physical activity interventions to help previously~     inactive women improve their body shape and composition. Many people seeking to lose weight~     or improve body composition initiate an exercise programme. The most common recommendation~     of an exercise intervention for someone attempting to manage their weight, has been to~     'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation),~     often using one mode of exercise. An alternative approach might be to offer a portfolio of~     activities, from which the exerciser can pick and choose, to facilitate greater amounts of~     physical activity. The problem with this is how do you account for the different intensities~     of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the~     investigators will try to overcome this barrier by allocating a number of physical activity~     points to each activity. Using this physical activity points system, participants will be~     provided with a points target that they can meet using any combination of activities.~      The investigators research aim is therefore to compare this points-based system against the~     traditional 5x30minute prescription (and sedentary control) for their ability to help~     previously inactive women to drop a dress size, increase fat burning, positively change~     their body composition and tone their tummy.~   "
79240|NCT02020226|"~     The Primary objective of this study is:~      1. To determine the cardiac safety of TH-302 in patients with advanced solid tumors~      The Secondary objectives are:~        1. To assess the pharmacokinetics (PK) of TH-302~        2. To evaluate whether there is an association between plasma exposure to TH-302 and its~          active metabolite, Br-IPM, and effects on cardiac repolarization~        3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid~          tumors~   "
79241|NCT02020213|"~     Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except~     administrating empirical anti-fungal agent, using objective parameters to support the~     tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically~     is also important. At present, serum galactomannan (GM) test is the less-invasive,~     non-cultural, and time-saving examination for augmenting a diagnosis of Aspergillosis. It~     was suggested by Infectious Disease Society of America (IDSA) 2008 as a screening and~     monitoring tool for Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA .~     However, in clinical practice, GM seems not to have good predicted value even the~     sensitivity and specificity are declaimed more than 80% . Other controversial issues include~     the reproducibility of GM5 and the effect of piperacillin-tazobactam or other antibiotics on~     the accuracy of GM baseline In this study, serum GMs are examined in two conditions, one is~     collected for establishing a baseline and the other is collected after~     piperacillin-tazobactam administration. We hope to confirm the validity of GM baseline and~     the effect of piperacillin-tazobactam on GM value in Taiwan.~   "
79242|NCT02020200|"~     The purpose of the study is to explore the effect of MPH on working memory, attention and~     decision making in adults with BD in remission or in depressed state. The results will be~     compared to findings in healthy adults and adults with ADHD. The investigators hypothesize~     that MPH will incur improved performance in all measures.~   "
79243|NCT02020187|"~     Congenital myopathies are clinical and genetic heterogeneous disorders characterized by~     skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout~     their life. However, progression of symptoms is rare. There are no specific treatments for~     congenital myopathies. Training has been shown to benefit several other muscle diseases with~     weakness, but the defect in congenital myopathies involves contractile proteins of the~     sarcomere, why the effect of training is uncertain in these conditions. The investigators~     will therefore investigate the effect cycle-ergometer training for 30 minutes, three times~     weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital~     myopathy patients, who do not train, will serve as controls for the trained patients. The~     study starts and ends with a test day, where efficacy based on VO2max, performance in~     functional tests and a questionnaire will be assessed.~   "
79244|NCT02020174|"~     The purpose of The Preeclampsia Registry is to collect and store medical and other~     information from women who have been medically diagnosed with preeclampsia or a related~     hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP~     syndrome, their family members, and women who have not had preeclampsia to serve as~     controls. Information from participants will be used for medical research to try to~     understand why preeclampsia occurs, how to predict it better, and to develop experimental~     clinical trials of new treatments.~   "
79245|NCT02020161|"~     Therapeutic guidelines for treatment of patients with de novo APL to be used by every~     institution that wants to follow them. All patients who are reported may be retrospectively~     analyzed~   "
79246|NCT02020148|"~     The goal of this research study is to understand the relationship between the hormone~     oxytocin and postpartum mood. Based on previous research, the investigators hypothesize that~     lower plasma oxytocin concentration during pregnancy will predict a greater likelihood of~     postpartum depression. Second, it is expected that oxytocin concentration in the third~     trimester will show an inverse relationship with the severity of depressive symptoms at 4 -~     6 weeks postpartum.~      Potential participants in the study will be screened for eligibility during their third~     trimester of pregnancy, using a combination of questionnaires. Those who are eligible for~     participation will have one blood sample drawn at this time, and then be asked to complete a~     follow up questionnaire at 4-6 weeks postpartum to assess for depressive mood symptoms. This~     follow up questionnaire can be completed either in person or on the telephone. Anyone who is~     interested in receiving help for their mood at any point in the study will receive~     referrals.~   "
79247|NCT02020135|"~     PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as~     measured by radiographic imaging and biomarkers, safety and tolerability of PSMA ADC in~     subjects with mCRPC. Subjects who have participated in the PSMA ADC 2301 study and who, in~     the opinion of the Principal Investigator are likely to benefit from continued treatment~     with PSMA ADC are eligible for the PSMA ADC 2301 extension study. Subjects who are~     benefiting from treatment may be able to receive up to an additional eight to sixteen doses~     (every 3 weeks) of PSMA ADC.~   "
79248|NCT02020122|"~     To utilize the plasticity of the central pain pathways in order to (i) shift individuals~     with a pro-nociceptive pain modulation profile towards an anti-nociceptive one, and (ii)~     assess its relevance in minimizing pain-derived morbidity.~   "
79250|NCT02020096|"~     Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block~     performance. It allows direct visualization of nerve structures, needle guidance in~     real-time to the target, and observation of local anesthetic diffusion. Some case series~     have demonstrated significantly faster onset time for interscalene blocks, supraclavicular~     blocks and axillary brachial plexus blocks under ultrasound than with conventional~     techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block~     at the popliteal fossa compared with single injection, nerve stimulator-guided block using~     either a tibial or peroneal endpoint. Despite this impressive profile, the application of~     the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that~     lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is~     equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar~     plexus block is traditionally performed using surface anatomical landmarks and nerve~     stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of~     its deep anatomic location and the acoustic shadow of the overlying transverse processes.~     Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of~     the lumbar paravertebral region with the ultrasound beam being insonated through the~     intertransverse space (ITS) and directed medially toward the intervertebral foramen~     (PMTS-ITS) may overcome the problem of the acoustic shadow and allow clear visualization~     of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar~     plexus blocks has not been studied extensively and its advantages are not validated in a~     clinical study. Thus, we designed this prospective, randomized, subject and assessor~     blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar~     plexus block combined with nerve stimulation and a conventional technique on time required~     to readiness for surgery in patients undergo knee arthroscopy surgery.~   "
79251|NCT02020083|"~     The purposes of this study are to determine whether transporters expression levels and drug~     interaction between TDF and FTC could contribute to modulate the placental transfer of this~     drug or. To test this hypothesis, an ex vivo model known as the perfused ex vivo cotyledon~     model allows to reproduce the conditions of the third trimester of pregnancy~   "
79252|NCT02020070|"~     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab~     with degarelix before surgery to remove the prostate, followed by more degarelix and~     ipilimumab after the surgery, will have on prostate cancer.~      The goal of this trial is to assess the safety and efficacy of a multimodality approach~     combining hormones and immunotherapy in prostate cancer populations that are considered~     incurable and standardly treated with hormones alone, and represent clinical states prior to~     development of castration-resistant disease. There are 2 cohorts. The first will use~     ipilimumab and degarelix prior to and following radical prostatectomy in men with newly~     diagnosed, oligometastatic, castration-sensitive disease. The second cohort will include men~     who have already received definitive local therapy with radical prostatectomy but have since~     experienced biochemical and/or metastatic recurrence.~   "
79253|NCT02020057|"~     To our knowledge, there has been no information on in vivo clinical results of posterior~     cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated~     whether the clinical and radiographic results, incidence of post fracture of the tibial~     polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and~     the incidence of osteolysis would be similar between posterior cruciate-substituting total~     knee prostheses using conventional and highly cross-linked polyethylene.~   "
79254|NCT02020044|"~     The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty~     (DMEK and Ultra-thin DSAEK) for corneal transplantation.~   "
79255|NCT02020031|"~     The purpose of this study is to determine whether or not giving a lower dose of antibiotics~     (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing~     infection than the current standard dose which is given intravenously (IV) through a wrist~     vein.~   "
79256|NCT02020018|"~     Does a wound vac dressing prevent wound infection after heart surgery?~   "
79257|NCT02020005|"~     The primary aim of this study is to determine menthol smokers' perception, product~     preference, and pattern of use across six products including, mint-flavored nicotine gum;~     non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler.~     Participants will undergo an orientation and baseline assessment followed by a 2-week~     product sampling phase. At the end of the 2 weeks of sampling, subjects will select a~     product to use during the following 2-week smoking cessation phase. This 2-week abstinence~     phase is followed by one week of abrupt withdrawal of the product. This study design was~     successfully used in a study we conducted that examined the smokers' preference for a~     variety or oral tobacco products.~   "
79258|NCT02019992|"~     To determine the plasma levels of mtDNA in ICU department patients with and without sepsis~     and evaluate their association with severity, systemic inflammation and outcomes. Plasma~     from control, septic and severe septic patients will be collected. The level of mtDNA and~     systemic cytokine will be measured.~   "
79259|NCT02019979|"~     Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of~     cellular energy levels and a key enzyme limiting cellular growth during times of cellular~     stress. Once activated, this enzyme restricts anabolic processes such as protein,~     cholesterol and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for~     unregulated growth. MTOR is upregulated in a variety of tumors, including NSCLC providing~     rationale to take advantage of this pathway with metformin.~   "
79260|NCT02019966|"~     Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine~     (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy.~     In Korea, primarily owing to limited subsidization policy in the health insurance system,~     many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg~     monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients,~     rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with~     suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available~     in Korea for patients who had difficult-to-treat antiviral resistance owing to prior~     treatment failures. However, which is the better has not been evaluated yet. A long-term~     efficacy and safety of TDF-based rescue therapies in real practice for those patients should~     be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near~     future.~   "
79261|NCT02019953|"~     The overall approach to the study is to assess the feasibility of recruiting African~     Americans to participate in several health-promoting programs and to compare health outcomes~     among the three interventions.~   "
79262|NCT02019940|"~     This open label study will evaluate the safety and efficacy of riluzole in patients with~     PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient,~     with a one month follow up at week 16.~   "
79263|NCT02019927|"~     Transcorneal Electrical Stimulation (TES) using the OkuStim® device delivers electrical~     impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the~     retina may help to preserve visual acuity and/or the visual field.~   "
79265|NCT02019901|"~     Purpose: To compare a nurse-led clinic including person-centered care and tight control with~     care as usual in patients with rheumatoid arthritis (RA) and moderate/ high disease~     activity.~      Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high~     Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month~     randomized controlled study with a 6 month open follow-up. Intervention group (N=60):~     Nurse-led visits every 6th week, with structured person-centered care and evaluation of~     disease activity. If disease remission is not reached, pharmacological treatment including~     both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and~     biologics) is modified according to a predefined algorithm. The control group (N=60) is~     treated according to care as usual with visits to physician every 6th month. Outcome~     measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary~     outcomes are quality of life, self-efficacy, disability, emotional well-being, pain,~     fatigue, sleep and satisfaction.~   "
79266|NCT02019888|"~     The accurate assessment of auditory status is critical for planning treatment for Veterans~     with hearing loss to include medical and audiological management. Current physiologic tests~     of auditory function in the standard clinical audiological test battery for Veterans have~     limited sensitivity in detecting some middle-ear disorders, and do not include a direct test~     of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of~     absorbance for improved sensitivity in the assessment of middle-ear function including~     acoustic reflex testing. The addition of WB tests of cochlear function included in the WB~     test battery provides an opportunity to improve audiological diagnosis of a range of hearing~     disorders in Veterans. The automation provided by the WB test battery could provide~     additional benefits in reducing the duration of the evaluation, leaving more time for~     evaluation of test findings and counseling. Results from this study may lead to the~     improvement of audiological care for Veterans with hearing loss.~   "
79267|NCT02019875|"~     The purpose of this study is to determine whether changes in the activity of the enzyme~     CYP3A4 can change the Vitamin D and bone mineral homeostasis.~   "
79268|NCT02019862|"~     Clinical and radiological 2 years results of TRJ® Hip Stem.~   "
79269|NCT02019849|"~     Twelve months follow-up of implant survival and clinical and radiological follow-up of~     Plasmafit® Cup.~   "
79270|NCT02019836|"~     Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with~     or without accompanying bacteremia in the first month of life which is still an important~     cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily~     contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In~     addition to its classical role in bone metabolism, vitamin D also has immunomodulatory~     effects on immune function. Although some studies reported a link between vitamin D~     deficiency and critical illness in adults, a direct relationship has not been directly shown~     yet. However, to the best of our knowledge, no study evaluated the association between EOS~     and maternal/neonatal vitamin D levels. The objective of this prospective study is to~     determine the possible role of maternal and neonatal plasma vitamin D levels on EOS~     development in term infants. We also aim to evaluate possible effect of the severity of~     vitamin D deficiency on EOS development in the study population.~   "
79271|NCT02019823|"~     General synopsis for SMS-text Adherence Support (*StAR) Study and associated preparatory and~     pilot work~      Background: High blood pressure is an important risk factor for heart disease, stroke and~     chronic kidney disease. Clear evidence exists that for individuals with high blood pressure~     (hypertension) lowering blood pressure really reduces this risk. One of the critical factors~     in the long term control of blood pressure is the regular use of effective antihypertensive~     medications. In South Africa, poor treatment adherence (attending clinic, re-filling~     prescriptions, and regularly taking hypertension tablets) is known to be an important and~     alterable risk factor for uncontrolled high blood pressure and its complications (heart~     disease, stroke and chronic kidney disease). SMS-text messages have been shown to improve~     clinic attendance and medication adherence for some diseases (like HIV and TB) in other~     low-resource settings. It is not clear whether SMS-text messages to support treatment~     adherence have an effect on long-term blood pressure control. The acceptability,~     sustainability and scalability such technology also remains to be determined.~      Aim: To investigate if a system of SMS-text messages to support treatment adherence is more~     effective than usual care for controlling high blood-pressure.~      Objectives: The main objective is to test whether advice and support given by SMS-text,~     either by providing information (informational) or by allowing a two-way communication~     (interactive) improves control of blood pressure at one year compared to usual care.~      Additional objectives include assessing whether the interventions have an effect on,~        -  Clinic attendance~        -  Prescription refill adherence~        -  Self-reported medication adherence~        -  Hypertension related illness or death~        -  Patient empowerment~      Study design: Single centre randomized three-arm parallel group trial As it is not clear how~     best to support treatment adherence for people with hypertension we need to compare the~     different ways this might be done. Eligible patients who provide written consent will be put~     into one of three groups and then compared. The groups are selected by a computer which has~     no information about the individual (i.e. by chance). Participants in each group will get~     different types of SMS-text messages and these are compared.~      Study interventions:~        -  Enhanced usual care In addition to their usual clinical care participants will receive~          the pre-randomisation Welcome to the *StAR Study SMS-text, a Happy Birthday~          SMS-text on their date of birth and up to six additional SMS-text messages containing~          study specific information and thanking the participant for taking part in the study.~        -  Informational SMS-text messages In addition to enhanced usual care, participants~          allocated to the informational SMS-text support group will receive semi-tailored~          structured adherence-support (including clinic appointment and medication pick-up~          reminders, medication adherence support and hypertension-related education.)~        -  Interactive SMS-text messages In addition to enhanced usual care and informational~          SMS-text messages, SMS-text messages sent to participants in the interactive SMS-text~          group will contain a prompt to respond which will guide participants to additional~          SMS-text based resources.~      Outcome measures: The main outcome measure is mean blood pressure measured at one year.~     Additional outcomes include the proportion of participants with controlled blood pressure~     as well as measures of clinic attendance, prescription refill adherence, self-reported~     medication adherence, hypertension related illness or death, and patient empowerment.~   "
79272|NCT02019810|"~     Severe traumatic brain injury with increased intracranial pressure can lead to decreased~     cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading~     to bad prognosis. It is not yet established whether increasing cardiac output in these~     patients can lead to an increase in cerebral blood flow, although there are some arguments~     in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac~     output will improve cerebral blood flow in patients with severe traumatic injury and high~     cerebral pressure.~   "
79273|NCT02019797|"~     This study examines pharmacological preconditioning and post conditioning of desflurane by~     comparing cardiac troponin release in patients receiving either desflurane or propofol for~     the aortic valve surgery.~   "
79274|NCT02019784|"~     Patients with cirrhosis are particularly prone to infection which is frequently a~     precipitant of hepatic encephalopathy, renal failure and circulatory collapse. Bacterial~     infections are of particular concern in patients with cirrhosis because they are poorly~     tolerated. Sepsis and associated endotoxaemia whereby bacteria produce inflammatory~     particles occur in approximately 40% of hospitalized patients with cirrhosis and is a major~     cause of death.~      Gut-derived and blood-borne pathogens can induce an inflammatory response within the liver~     and spleen, which are the major organs that remove bacteria and their endotoxin (such as~     lipopolysaccharide - LPS and bacterial DNA itself) from the bloodstream. Several mechanisms~     have been identified and proposed in this process which depends upon a balance between the~     barrier functions of the gut and the 'detoxifying' capacity of the liver. People with~     established liver cirrhosis have been shown to have escape of endotoxin into the bloodstream~     produced by bacteria that reside in their intestines, which becomes more permeable or~     'leaky'.~      Gut dysfunction is defined by changes in the types of bacteria within the gut and in overall~     permeability allowing bacterial products which would otherwise be contained within the gut~     to travel into the bloodstream and lymphatic system with detrimental effects elsewhere in~     the body. This passage of bacterial products is termed bacterial translocation, and it's~     effects on the liver and general immune system can be then be measured.~      It has now become recognised that certain types of white blood cells such as neutrophils and~     monocytes become dysfunctional and this predisposes to infection and may also have a more~     direct pathogenic role in hepatic encephalopathy. Thus neutrophil and monocytes may be a~     novel pharmacotherapeutic target in a condition where current therapies such as bowel~     aperients (e.g. lactulose) are inadequate. A therapeutic strategy utilising Rifaximin, a~     non-absorbable antibiotic, to modulate gut bacterial which produce ammonia, a chemical known~     to be important in the cause of hepatic encephalopathy, could potentially lower gut-derived~     systemic inflammation, endotoxaemia, infection and organ dysfunction in this population~     improving outcomes and prolonging transplant-free survival.~      We therefore plan to test if Rifaximin positively affects markers of immune dysfunction in~     patients with liver cirrhosis experiencing chronic hepatic encephalopathy after 30 days of~     treatment, as our primary research question.~      Positive results from this study would support further trials into the potential benefit of~     using Rifaximin to improve immune function, as well as reduce the recurrence of hepatic~     encephalopathy, in patients with liver cirrhosis.~   "
79275|NCT02019771|"~     Hypothesis: Men who have sex with men (MSM) are at higher risk for sexually transmitted~     diseases. Currently, free testing for sexually transmitted diseases is only being performed~     in urine samples. Investigators hypothesize that the rates of both gonorrhea and chlamydia~     will be higher when testing includes more than one anatomical site (rectum and oropharynx).~      The aim of the study is to estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in~     the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at the~     specialty care center of the University of Nebraska Medical Center and compare to the rates~     in Douglas County, using nucleic acid amplification tests.~   "
86882|NCT01920165|"~     The purpose of this study is to investigate whether there has been a change in the number of~     hospital admissions for respiratory tract infections among children following the July 2007~     introduction of a ban on smoking in public places in England.~   "
79276|NCT02019758|"~     Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose~     inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms,~     which medication provides a more durable treatment response, and whether biomarkers can~     predict treatment response.~      Participants: A total of 122 16-80 year old patients with a new diagnosis of eosinophilic~     esophagitis (EoE) who are referred for upper endoscopy.~      Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical~     trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will~     generate data for all three Aims~   "
79277|NCT02019745|"~     Chronic exposure to (cigarette smoke) CS causes biological changes, including airway~     remodeling and changes in baseline gene expression profiles at the level of the epithelium.~     Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells~     to enhance antiviral gene expression in response to influenza infection and activate host~     defense responses. While there is a large body of evidence supporting the notion that~     exposure to CS causes significant changes in host defense responses, which may be linked to~     permanent changes in epithelial cells at the genomic level, it is not known whether new and~     emerging tobacco products have similar or distinct effects.~      Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study~     will compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS),~     e-cigarette smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This~     will be done by analyzing nasal viral titers, antiviral defense responses, inflammatory~     mediator production, and markers of immune responses for LAIV-induced responses between the~     different groups of volunteers.~   "
79278|NCT02019732|"~     This is a database study to quantify the burden of multiple mild outcomes (i.e., those that~     result in visits to a physician's office) attributable to influenza in the United States,~     stratified by age group, geographic region and influenza subtype for selected influenza~     seasons.~   "
79279|NCT02019719|"~     This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin~     (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic~     kidney disease (CKD). It is anticipated that the data generated will enable selection of the~     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This~     study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a~     follow-up visit approximately 4 weeks after completing treatment.~   "
79280|NCT02019706|"~     Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have~     ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes~     cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot~     be found initially despite very detailed and extensive imaging, including studies such as~     computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the~     standard dose of indium-111 pentetreotide ([(111)In-DTPA-D-Phe]-pentetreotide). The~     sensitivity and specificity of structurally based imaging studies depends on anatomic~     alterations and the size of the tumor. In contrast, positron emission tomography (PET) and~     somatostatin ligand (like octreotide) imaging detect pathologic tissue based on physiologic~     and biochemical processes within the abnormal tissue. This protocol tests the ability of~     [(18)F]-L-3,4-dihydroxyphenylalanine ((18)F-DOPA) PET, Octreoscan and another somatostatin~     imaging analogue, (68)Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.~     The study also examines whether administration of the glucocorticoid antagonist mifepristone~     can improve the sensitivity of the (68)Ga-DOTATATE PET/CT.~   "
79281|NCT02019693|"~     Background:~        -  Papillary RCC is the second most common histologic subtype of kidney cancer, accounting~          for approximately 10-15% of cases~        -  Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are~          histologically identical. Non familial type 1 papillary RCC can present as both~          solitary renal tumors and as bilateral, multifocal disease~        -  There are no standard agents of proven efficacy for patients with advanced papillary~      RCC.~        -  Patients with disease localized to the kidney are managed surgically while patients~          with advanced/unresectable disease are usually managed in the community with VEGF~          pathway antagonists or mTOR inhibitors.~        -  Activating mutations of MET were identified in the germline of affected HPRC patients,~          who have a predilection for the development of bilateral, multifocal type 1 papillary~          RCC. Somatic MET mutations have been found in a subset of patients with non-inherited,~          sporadic papillary renal carcinoma~        -  The investigational agent INC280 is a selective MET inhibitor lacking activity against~          the VEGF pathway~        -  This is a proof-of-concept study using INC280 in patients with papillary RCC to test~          the idea that effectively blocking the HGF/MET pathway will lead to clinical activity~          in patients with papillary renal cell cancer~      Objectives:~      Primary Objective:~      -To determine the overall response rate (RECIST 1.1) in patients with papillary renal cell~     carcinoma treated with single agent INC280~      Eligibility:~        -  Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal~          cell carcinoma (RCC)~             -  Patients with bilateral multifocal disease can have tumors localized to the kidney~               or have metastatic disease~             -  Patients with sporadic papillary RCC (but without multifocal disease) should have~               advanced disease that is considered unresectable~        -  ECOG 0-2~        -  Measurable disease~        -  Adequate organ function~        -  No active brain metastases~        -  Prior therapy~             -  No more than 3 prior lines of systemic therapy~             -  Prior therapy with a MET inhibitor is allowed as long as the patient has not had~               progressive disease while receiving the agent~      Design:~        -  This is a phase 2 single center non-randomized trial.~        -  The study will be conducted using a Simon 2 stage minimax design. Initially 13~          evaluable subjects will be recruited. If there are no responses to therapy, the study~          will be terminated. If there is at least 1 response an additional 7 evaluable subjects~          will be accrued.~        -  The two-stage minimax design is based on assuming an ineffective response rate of 5%~          and a targeted effective response rate of 25%. We also assume that the probability of~          accepting an ineffective treatment and the probability of rejecting an effective~          treatment are each 10%.~        -  Subjects will be dosed orally at a starting dose of 600 mg twice daily.~        -  The overall response rate (complete response + partial response) will be determined.~   "
79282|NCT02019680|"~     Background:~      - Heart disease is the leading cause of death in the United States. Eating fruits and~     vegetables with chemicals called flavonoids may protect against heart disease and improve~     blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and~     mussels called omega-3 fats have also been shown to protect the heart. Researchers want to~     know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase~     blood to the heart. They also want to learn about the health of blood vessels and how the~     heart works.~      Objective:~      - To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the~     heart beat stronger.~      Eligibility:~      - Healthy adults 55 to 75 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Visit 1 will take 6 7 hours.~        -  Participants will have physical exam and blood and urine tests.~        -  A small device like a microphone will be placed on their arm to take pictures of blood~          vessels. A blood pressure cuff will be tightened on their arm and more pictures will be~          taken.~        -  Blood pressure cuffs will be placed on their arms and legs. They will be tightened at~          the same time and blood pressure will be measured.~        -  Participants will answer questions about their eating and exercise.~        -  Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a~          placebo to no tablets. <TAB>~        -  Every 8 weeks, they will have another shorter clinic visit that will repeat most of~          visit 1.~   "
79283|NCT02019667|"~     Objective:~      To perform a clinical trial assessing the safety, tolerability and efficacy of the GABA(B)~     receptor antagonist SGS-742 in patients with SSADH deficiency.~      Study Population:~      Twenty-two children and adults with SSADH deficiency.~      Design:~      Double-blind, cross-over, phase II clinical trial. SGS-742 is a GABA (B) receptor antagonist~     that has shown to be safe and well-tolerated in clinical trials in adults with cognitive~     impairment. In addition, preliminary data in the SSADH knockout mouse model suggest efficacy~     in this specific syndrome. The primary outcome measure will be a change in the Auditory~     Comprehension subtest of the Neuropsychological Assessment Battery Language Module score;~     the secondary outcome measure will be a change in cortical excitation and inhibition~     measured by transcranial magnetic stimulation (TMS). Additional evaluations will include~     neurological and neuropsychological examinations, magnetic resonance spectroscopy and CSF~     collection to measure GABA levels. The trial will have a baseline phase in which each~     patient will undergo a neurological examination and a neuropsychological evaluation. During~     the subsequent treatment phase, patients will be randomized to SGS-742, supplied by IRIX~     Pharmaceuticals, and based on weight given a maximum tolerated dose not to exceed 600 mg~     t.i.d. orally, or placebo, each for 6 months. Patients will then have repeat TMS,~     neurological and neuropsychological evaluations, followed by cross-over to the alternate~     treatment arm, and re-evaluation after 6 months.~      Outcome Measures:~      The primary outcome measures for drug efficacy will be performance on neuropsychological~     testing and responses to parent questionnaire. The secondary outcome measure will be TMS~     parameters of cortical excitation and inhibition. The outcome measures for safety will~     include clinical examination and neuropsychological tests.~   "
79284|NCT02019654|"~     Objective: A traumatic brain injury (TBI) places individuals at high risk for developing~     posttraumatic stress disorder (PTSD). TBIs account for the onset of PTSD in approximately~     700,000 Americans each year. Depression and post-concussive syndrome (PCS) are also common~     and often comorbid with PTSD. However, even in this group, there is a high-level of~     inter-individual response to traumatic brain injuries, suggesting that a better~     understanding of the mechanisms underlying this risk would be of great value in directing~     preventive interventions. The reasons for this heterogeneity are undoubtedly~     multi-factorial, and involve a complex interplay between genetic and environmental factors,~     that we may be able to understand through peripheral biomarkers and central examination of~     neuronal functioning. We suggest that DNA methylation may be a putative biomarker of~     psychiatric risk, as it reflects long-term changes in the function of the gene and may shape~     the recovery ability of the TBI patient through changes in cell function. In addition,~     differential proteomic response, including the function of the neuroendocrine system, likely~     relates to changes from epigenetic modification in both neurons and immune cells, which may~     contribute to the risk for the onset of PTSD as well as depression and PCS. We have~     previously shown that both PTSD and depression are associated with endocrine alterations,~     leading us to question if this biological change may underlie vulnerability for the onset of~     PTSD as well as depression and PCS following a TBI. In support of the idea of shared~     vulnerability, patients with a TBI also often display endocrine function alterations. In~     addition, sleep disturbance is common following TBI and is a core symptom of PTSD depression~     and PCS, suggesting that sleep may contribute to psychiatric and neurological recovery from~     a TBI. This line of research is essential, as current treatments to prevent or treat~     psychiatric risk following TBI are often ineffective, and even treatment of PCS is limited.~     This poor understanding results in our limited ability to reduce the risk for compromises in~     the health and well-being of patients who sustain a TBI.~      Study population: Participants with a moderate or mild TBI (n=100) will be followed for a~     period of one year.~      Design: This is a natural history study that will recruit patients within 30 days of a~     mild/moderate TBI, and will follow them over a one year period, with follow-up at 1, 3, 6~     and 12 months following the TBI. Biological profiles including the concentration of~     inflammatory proteins and neuropeptides, and DNA methylation will be examined. An optional~     structural and functional magnetic resonance imaging (fMRI), and a hydrocortisone~     stimulation test will be used to evaluate the role of neuronal and neuroendocrine~     functioning following TBI.~      Outcome measures: The primary outcomes of interest are the biological changes that occur~     following TBI which are associated with the onset of psychiatric disorders of PTSD, and~     depression, as well as the onset of PCS. The secondary aim is to examine neuronal mechanisms~     that underlie the risks for these disorders through the use of fMRI. Additional aims will~     determine the role of psychological resilience traits in recovery and also how sleep relates~     to recovery and psychiatric risk.~   "
79285|NCT02019641|"~     Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from~     several different insults to the lung parenchyma: inhaled substances, drug side effects,~     connective tissue disease, infection, and malignancy. The disease can also be of idiopathic~     origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic~     reorganization of the parenchyma and small airways, which reduces the distensibility of the~     lung and impedes O2 and CO2 exchange.~      This study is a randomized controlled trial to determine the safety and efficacy of aerobic~     exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary~     hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory~     function, increased physical work capacity, and improved health-related quality of life~     following aerobic exercise in this study population. Serious adverse events resulting from~     aerobic exercise training were not observed and our work to date has established~     plausibility for the efficacy of aerobic exercise training and its safety for patients with~     ILD.~   "
79286|NCT02019628|"~     The present study investigated the effect of RBAC on natural killer cell activity (NKCA) and~     the production of cytokines and growth factors over 4 weeks among healthy adults.~   "
79287|NCT02019615|"~     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5~     consecutive days in chronic patients in minimally conscious state (MCS).~      2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each~     stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised~     (CRS-R). A final assessment will be done one week after the end of the sessions to assess~     the long term effect of the tDCS.~   "
79288|NCT02019602|"~     The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from~     pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating~     the concentration of CZP in the plasma of infants at birth.~   "
79289|NCT02019589|"~     This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled,~     parallel group, multiple-dose design.~      The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period~     (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and~     Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be~     performed at the following time points:~      Screening Period:~      • Screening Period (approximately 42 Days)~      Open-Label Estrogen Priming Period (Run In Period):~        -  Visit 1 Baseline (Cycle 1, Day 1)~        -  Telephone Interview (Cycle 1, Day 28 [- 3 d to ±1d])~      Blinded Treatment Period:~        -  Visit 2 Randomization (Cycle 2, Day 12 [±2d])~        -  Visit 3 Interim (Cycle 3, Day 12 [±2d])~        -  Visit 4 End of treatment (Cycle 3, Day 24 [±1d])~      Follow-Up Period:~        -  Visit 5 Follow-Up (Approximately 10 days after the last treatment)~        -  Telephone Interview (Approximately 2-4 weeks after completion of progestin course)~          (Only applies to subjects receiving an approved progestin therapy for proliferative~          endometrium, as determined by biopsy.)~   "
79290|NCT02019576|"~     Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely~     and accurately delivers high dose radiation to a tumour, while sparing much of the nearby~     normal organs. The use of stereotactic radiotherapy results in high rates of tumour~     destruction with minimal side effects which are very well tolerated. Often stereotactic~     radiotherapy has been used to try to cure patients who have an early stage cancer which has~     not spread, but there is less experience with using it in patients with cancer which has~     spread.~      The purpose of this study is to measure how well stereotactic radiotherapy can destroy~     kidney cancer tumours which are no longer being controlled by Sunitinib and to measure how~     much longer such an approach will allow patients to stay on Sunitinib before needing to~     switch to another medication. Stereotactic radiotherapy will be used to treat only the~     growing tumours and then patients will continue with Sunitinib.~   "
79291|NCT02019563|"~     To compare radiographic and clinical outcomes and survival of mineral trioxide~     aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital~     primary maxillary incisors.~   "
79292|NCT02019550|"~     This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to~     evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with~     relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up~     to 10 weeks (including screening and treatment periods). The treatment period will last 8~     weeks and include 12 self-injections using the Rebif® Rebidose® device and 12~     self-injections using the Rebiject II® device.~   "
79293|NCT02019537|"~     The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with~     subacromial impingement disease~   "
79294|NCT02019524|"~     This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate~     binding protein vaccines E39 and J65. The study target population are patients with breast~     or ovarian cancer diagnosis who have been treated and are without evidence of disease.~     Disease-free subjects after standard of care multi-modality therapy will be screened and HLA~     typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted~     to HLA-A2+ patients (approximately 50% of the U.S. population).~   "
91371|NCT01861236|"~     Prospective, observational study to collect and analyze data on patients with advanced~     hormone dependent prostate cancer treated with Firmagon® according to routine medical~     practice in Argentina~   "
79295|NCT02019511|"~     It has been shown that a single high dose of steroid before surgery may reduce pain the~     first 48 hours after insertion of a new joint in the knee, a so called total knee~     arthroplasty (TKA). Consequently, this has been introduced as standard treatment of most~     patients at several Danish orthopedic departments. Although there are some concerns about~     the possibility of increased risk of prosthesis infections, this has not been proved in~     previous studies. However the studies are few, have limited number of patients and are not~     done using a standardized perioperative set-up.~      This study is made to monitor the safety of a single high dose steroid injection before TKA,~     with regards to prosthesis infection within one year of surgery.~      We hypothesize that there will be no increase in infections in patients receiving steroid~     injection before TKA compared to a historical cohort of patents who did not receive a~     steroid injection before their TKA.~   "
79296|NCT02019498|"~     The aim of the pragmatic randomized study is to evaluate whether additional relaxation~     technique is more effective in the reduction of chronic low back pain compared to usual care~     alone.~   "
79297|NCT02019485|"~     The purpose of this study is to evaluate bioequivalence (biological equivalence of two~     formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg~     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg,~     prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted~     (without food) conditions.~   "
79298|NCT02019472|"~     The primary objective is to investigate the efficacy of sirukumab monotherapy compared with~     adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are~     intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate~     or who are inadequate responders to methotrexate.~   "
79299|NCT02019459|"~     Smokers with schizophrenia (SWS) infrequently attempt and attain sustained smoking~     abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study~     will examine whether reducing the nicotine content of cigarettes to non-addicting levels is~     a viable method of reducing smoking in this population. Smokers will be randomized to one of~     two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal~     nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco~     use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal~     symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking~     topography.~   "
79300|NCT02019446|"~     Fungal infections of the toe affect one in three people with diabetes. Current treatments~     for fungal toe infections include oral medications, but these drugs often interact with~     other common medications. We are studying a new treatment for fungal toe infections~     involving the use of a laser device. We will compare to the standard treatment which is a~     type of antifungal medication. This laser has been tested in small numbers of patients with~     minimal side effects. There will be 60 participants selected for our study, of which 30 will~     receive standard treatment and the rest will receive laser treatment.~   "
79301|NCT02019433|"~     Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment~     Structan®~   "
79302|NCT02019420|"~     This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3~     study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days~     versus linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the~     treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial~     pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Participants with~     concurrent gram-positive bacteremia are to receive 14 days of active therapy in either~     treatment arm.~      Approximately 300 sites will participate. Ventilated participants with HABP/VABP caused by~     presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will~     be randomized 1:1 to study drug treatment.~   "
79303|NCT02019407|"~     Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI)~     Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be~     composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation~     with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society)~     2010 expert consensus guideline.~   "
79304|NCT02019394|"~     To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady~     state~   "
79305|NCT02019381|"~     Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society~     have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the~     effects of both of them on calcium metabolism and bone turnover. We propose a one year~     randomized double blinded study for the same.~   "
79306|NCT02019368|"~     This is a randomized, double-blind, placebo controlled, crossover study to determine the~     antioxidant effect of aged garlic extract. This study will also compare the oxidative status~     in heavy smokers with that in non-smokers.~   "
79307|NCT02019355|"~     The main purpose of this study is to determine the effectiveness of a new combination~     therapy for actinic keratosis. This study investigates a new indication for an FDA-approved~     topical medication, calcipotriol, for treatment of actinic keratosis, including how well it~     works and how safe it is when used in combination with the standard of care medication~     (5-fluorouracil) for the skin condition.~   "
79308|NCT02019342|"~     The purpose of this study is to determine~        1. whether intraoperative hypotension or hypertension is independently associated with~          postoperative mortality and morbidity~        2. whether quality improvement interventions implemented at the University of Michigan and~          at Washington University:~             1. decrease the extent and duration of intraoperative hypotension and hypertension.~             2. are associated with decreased postoperative mortality and morbidity.~   "
79309|NCT02019329|"~     This randomized, double-blinded, placebo-controlled study will investigate the safety,~     tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to~     psychiatrically stable patients with schizophrenia receiving risperidone.~   "
79440|NCT02017626|"~     The aim of this study is to investigate the safety and tolerability of Subcutaneous~     Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish~     parvalbumin (mCyp c 1) quantified in mass units:~      To establish a safe dose of the candidate hypo-allergen in human subjects and To study the~     pharmaco-dynamics of the hypo-allergen administered to human subjects.~      The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish~     allergic patients allocated into three different groups of eight.~   "
79310|NCT02019316|"~     BioSteel Sports Drink (BSD), a proprietary blend of branched chain amino acids, taurine, and~     B vitamins, has increased its popularity among professional and amateur athletes. BioSteel~     claims that BSD attenuates muscular and mental fatigue, and enhances recovery when consumed~     before and during intense exercise. To date, the efficacy of BSD on attenuating muscular and~     mental fatigue, and enhancing recovery during repeated bouts of intense exercise is unknown.~     In a blind crossover study, participants will be subjected to sprint interval exercise~     followed by muscular and cognitive function testing under two conditions: BSD and~     isoenergetic control.~   "
79311|NCT02019303|"~     To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy~     (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed~     invasive breast cancer or suspected invasive breast cancer.~      Hypothesis: FNA and CNB have equivalent diagnostic accuracies~      In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each~     consented patient. The two samples will be evaluated separately by different pathologists~     blinded to the material in the other sample.~      The results of the biopsies will be compared to the gold standard (lymph node excision).~   "
79312|NCT02019290|"~     This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study~     examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy~     volunteers.~      A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight~     fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and~     after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be~     co-administered on Day 15, after an overnight fast.~      Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15~     days.~   "
79313|NCT02019277|"~     This open-label, multicenter, phase IIIb study will assess the safety, tolerability and~     efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), subcutaneous~     (SC) trastuzumab (Herceptin), and taxane chemotherapy (docetaxel, paclitaxel or~     nab-paclitaxel) as first-line therapy in participants with HER2-positive metastatic breast~     cancer (mBC). All participants will be treated with 3-week cycles of pertuzumab IV (840~     milligrams [mg] first dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams~     per 5 milliliter [mg/5 mL]). The taxane treatment regimen will be determined by the~     investigator. Participants will continue therapy until disease progression, unacceptable~     toxicity, or the participant withdraws consent, whichever occurs first. Time on study~     treatment is up to 2 years.~   "
79314|NCT02019264|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in~     overweight and obese subjects with CV disease and/or multiple CV risk factors.~   "
79315|NCT02019251|"~     The goal of this study is to evaluate the utilization of conventional 'thermally' polarized~     perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway~     spaces in subjects who have undergone single or double lung transplantation. This is an open~     label study expanding on current work here at Duke. Images will be obtained using 19F MRI~     during wash-in and washout for evaluation of ventilation efficiency.~   "
79316|NCT02019238|"~     Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of~     non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources~     should be more efficacious than PVI combined with ablation of only documented non-PV~     triggers of AF in achieving long-term arrhythmia control in patients with persistent or long~     standing persistent AF.~   "
79317|NCT02019225|"~     The purpose of the TiME Trial is to determine whether dialysis facility implementation of a~     minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with~     end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has~     benefits on mortality, hospitalizations and health-related quality of life.~      The trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial~     in partnership with two large dialysis provider organizations.~   "
79318|NCT02019212|"~     The purpose of this study is to evaluate the quality and prognostic ability of low dose~     99mTc-tetrofosmin Myocardial Perfusion SPECT Imaging.~   "
79319|NCT02019199|"~     This study is a research initiative established to explore the use of magnetic resonance~     imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation~     therapy.~   "
79320|NCT02019186|"~     The endothelium is the lining of the blood vessels that helps prevent damage to the vessels.~     The endothelium does not function as well as it should in adolescents with type 1 diabetes.~     This causes future diabetes complications. Adolescents with diabetes also have abnormalities~     of the cells that repair the endothelium. These abnormalities may be due to damage caused by~     intermittent hyperglycemia. This studied is designed to study whether low dose, combined~     Vitamin C and E supplementation improves endothelial function and repair in adolescents with~     type 1 diabetes.~   "
79321|NCT02019173|"~     The purpose of this study is to determine~        1. if it is practical to treat moderately to severely brain injured patients who have~          problems with their balance and mobility in a group boot camp (3 days a week, 6~          hours/day for 4 weeks) exercise class.~        2. If they show improvements compared to 4 weeks of not receiving this treatment~        3. If electronic daily monitoring of their center of foot pressure during a standardized~          balance task will allow us to see small changes in ability.~      A baseline assessment of all outcome measures will be performed. This will be repeated 4~     weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all~     outcome measures will be performed one week later. A follow up of the Primary outcome~     measure, the PART-O participation questionnaire will be done 12 weeks later.~      Participants will attend group therapy consisting of a variety of exercises designed~     specifically to target balance and mobility deficits and based on the concept that through~     Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of~     neural adaptation. Exercises will be both individualized (delivered in a circuit) and group~     activities. Supervision and guidance will be provided by a registered Physical Therapist and~     a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any~     adverse events, and any need for extra staff will be recorded on a daily basis. As well, a~     standardized individualized task will be performed with center of foot pressure recording on~     a daily basis.~      Analysis: changes in outcome measures immediately after the non-intervention compared to the~     after the intervention period will be statistically determined to estimate efficacy of this~     treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse~     events will be used to support feasibility and safety of this model.~   "
79441|NCT02017613|"~     The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K~     delta/gamma inhibitor in patients with hematologic malignancies.~   "
80293|NCT02006459|"~     We want to investigate the mechanisms of extrapancreatic effects on~     gastrointestinal-mediated glucose disposal. In order to do so we will perform oral glucose~     tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised~     patients and in healthy controls.~   "
79322|NCT02019160|"~     -  Aim: This randomised controlled trial will systematically compare the efficacy of a 25%~          AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting~          caries teeth among preschool children when applied at half-yearly intervals over a~          30-month period.~        -  Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement~          will be followed for this 30-month, randomised, double-blinded, non-inferiority~          clinical trial. Approximately 2,400 kindergarten children will be screened and at least~          826 children with caries will be recruited. This sample size is sufficient for an~          appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of~          α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into~          2 groups to treat their caries over a 30-month period: Group A - biannual application~          of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual~          application of a 38% SDF solution followed by a placebo varnish.Clinical examinations~          will be conducted at 6-month intervals to assess whether the caries are arrested.~          Information on confounding factors such as oral hygiene habits will be collected~          through a parental questionnaire.~        -  Possible results and implications: As the first of its kind, this study would help to~          determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting~          childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride,~          respectively, than 38% SDF, their use would be more favourable than SDF in young~          children.~   "
79323|NCT02019147|"~     Despite recent advances in the care of mothers and newborn infants, many infants~     (approximately 20 per 1000 live births) continue to need resuscitation at birth. A~     proportion of these infants will have sustained significant injury through interruption of~     their blood and oxygen supply prior to delivery (perinatal asphyxia). In 2-3 babies per 1000~     this will lead to brain swelling and the risk of long term brain injury called neonatal~     hypoxic-ischaemic encephalopathy (HIE). HIE remains a cause of neonatal death and long term~     disability. Early and accurate prediction of outcome would allow us to intervene during the~     window of the first 6 hours following birth, prior to secondary reperfusion and secondary~     brain injury. Estimating severity of injury can be difficult in newborn infants. Condition~     at birth does not predict neonatal, or longer term outcome. Biomarkers which could be~     measured at the time of birth and analysed at the bedside would offer these infants the best~     chance of timely and effective intervention. Through the BIHIVE study we have identified a~     number of predictive biomarkers in hypoxic-ischaemic encephalopathy. These markers are~     present in umbilical cord blood and have been identified through proteomic and metabolomic~     analysis of a stored biobank of samples from a recruited cohort of infants with perinatal~     asphyxia and hypoxic-ischaemic encephalopathy. We now wish to validate these biomarkers in~     an additional cohort, and will continue to explore new biomarkers in our stored biobank of~     umbilical cord samples. In addition we wish to assess our ability to predict~     neurodevelopmental and behavioural outcome in these infants. In this way we will determine~     the most robust biochemical and clinical markers for the prediction of early and medium term~     outcome in HIE. This study will establish the evidence base and validation of these~     biomarkers to the point where they can be developed into a bedside diagnostic algorithm~     which can be used in the labour ward to immediately identify those infants at risk of HIE in~     time to prevent secondary damage.~   "
79324|NCT02019134|"~     The aim of the pragmatic randomized study is to evaluate whether additional relaxation~     technique is more effective in the reduction of chronic neck pain compared to usual care~     alone.~   "
79325|NCT02019121|"~     Investigators aim to retrospectively research patients undergoing renal transplants that~     received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal~     function. Investigators hope to elucidate any association between renal transplant patients~     and perioperative dexmedetomidine administration, these include (but are not limited to)~     UOP, Cr/GFR, morbidity, mortality, in hospital complications and failure rate. Investigators~     will research both living and cadaveric renal transplants.~   "
79326|NCT02019108|"~     Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian~     adults. Excessive and unbalanced loads passing through the knee joint have been implicated~     in the progression of OA. Typical conservative treatment of OA has focused on increasing~     daily activity, without consideration for the underlying joint loading. This study aims to~     compare a 4-month walking program that aims to increase the angle of the foot (toe-out~     angle) during walking - a measure shown to reduce joint loading and OA disease progression -~     while increasing walking time/distance, with a standard walking program that aims to~     increase walking time/distance. It is predicted that the walking program focusing on~     increasing toe-out will provide greater reductions in self-reported knee pain and a greater~     reduction in unfavorable knee joint loading.~   "
79327|NCT02019095|"~     In a recent experimental study, the investigators showed that the growth factor Activin A is~     expressed in the lungs of rats with the acute respiratory distress syndrome (ARDS) at levels~     that are comparable with those determined in the bronchoalveolar (BAL) lavage fluid from~     patients with ARDS. In the same study, the administration of the Activin A inhibitor~     Folistatin resulted in attenuation of the histological damage of the ARDS-afflicted rat~     lung.~      The precise role of Activin A/Folistatin in acute respiratory failure associated with acute~     lung inflammatory pathology has not been elucidated yet. Therefore, the purpose of the~     present, observational study is to investigate the role of Activin A/Folistatin in~     respiratory failure due to ARDS and/or ventilator-associated pneumonia (VAP), also in~     relation with other biochemical markers, such as cytokines and surfactant-related proteins.~   "
79328|NCT02019082|"~     This study aimed to investigate the effect of low intensity cathodal direct current on the~     release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in~     diabetic foot ulceration.~   "
79329|NCT02019069|"~     This phase II clinical trial studies how well liposomal cytarabine-daunorubicin CPX-351~     (CPX-351) works in treating patients with relapsed or refractory acute myeloid leukemia or~     myelodysplastic syndrome. Drugs used in chemotherapy, such as liposomal~     cytarabine-daunorubicin CPX-35, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing.~   "
79330|NCT02019056|"~     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the~     Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease~     and Alcoholic Hepatitis.~   "
79331|NCT02019043|"~     This study aims to enhance syphilis testing among HIV-positive men who have sex with men~     (MSM), so that more men will undergo testing, they will test more often, and more cases will~     be treated early. The intervention will combine syphilis tests with the standard HIV blood~     tests that are routinely done every 3-6 months for persons in care at hospital-based HIV~     clinics in Toronto and Ottawa, Canada.~   "
79332|NCT02019030|"~     The purpose of this observational study is to evaluate the outcomes of using the~     PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on~     anticoagulation medication.~   "
79333|NCT02019017|"~     Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary~     symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial~     sweating. The headache is believed to be the most intense of all headaches and among many is~     totally disabling and of great personal and social consequences. For a small group of~     patients with episodic and most chronic form, drug therapy has little effect. For them,~     surgery can be a solution.~      Neuroradiology has found evidence of a possible original activation of cluster headache from~     the portion of the brain called hypothalamus. Furthermore, an activation of the~     parasympathetic nervous system through the sphenopalatine ganglion, which may also explain~     some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of~     Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve~     signals being blocked. The duration of such a blockade is believed to be 3-9 months.~      The purpose of the present study is to develop and evaluate a new surgical procedure with~     injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the~     symptoms of refractory cluster headache with a minimal invasive procedure.~      The main objective of the project is to determine the safety of BTA injection in the area of~     the sphenopalatine ganglion of refractory cluster headache and detect the adverse events.~     Secondary objectives are to identify the changes of headache attacks by the method used.~   "
79334|NCT02019004|"~     The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A)~     versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical~     lines between the eyebrows) wrinkles.~   "
79335|NCT02018991|"~     The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce~     allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM)~     with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of~     LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.~   "
79336|NCT02018978|"~     This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly~     reduce population-level HIV incidence. The study design is a two-arm community randomized~     controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access~     to an HIV center which will provide free HIV testing and counseling, (b) Educational~     activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected~     clients, (d) A onetime provision of a small amount of food or health products for sex~     partners of persons testing positive for HIV or reporting HIV risk behaviors when they come~     to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An~     income generation training program for people testing positive for HIV, (g) Transportation~     assistance in visiting the HIV Care and Treatment Clinic in the area for those who test~     positive for HIV, and, (h) Counseling and transportation support for those on medical~     treatment for HIV to assist them in attending scheduled appointments, and receiving and~     taking their medications as recommended by the clinic staff. The study will take place~     within two communities located in Kisarawe district, Tanzania. The intervention will occur~     over an 18-month period with outcomes assessed at baseline and post-intervention. The study~     hypothesis is that individuals in the intervention community will have a lower incidence of~     sexually transmitted infections (STIs) than those in the control community.~   "
79337|NCT02018965|"~     There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels~     and enable HIV-infected individuals to live longer. However, some participants taking~     anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing~     AIDS and non-AIDS-related complications.~      ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3.~     Niacin is effective in reducing cholesterol levels in the blood. This drug has been known~     for a long-time to treat dyslipidemia and it is used to improve favourably all the~     lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected~     patients. Recent scientific research shows that regular consumption of niacin-rich foods may~     also provide protection against Alzheimer's disease and age-related cognitive decline.~      The purpose of this study is to find out:~        1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could~          reduce T cell immune activation and enhance CD4 recovery;~        2. If ER niacin can improve your quality of life and your neurocognitive functions~   "
79338|NCT02018952|"~     The aim of this trial is to study the interest of ultrasonography among patients with septic~     arthritis.~      Currently, ultrasonography is useful for detecting small fluid effusions, for examining~     otherwise inaccessible joints, such as the hip and for helping the joint aspiration.~      Accurate assessment of disease activity and joint damage in septic arthritis is important~     for monitoring treatment efficiency and for prediction of the outcome of the disease.~      Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or~     tomography for the detection of joint effusion and for differentiation between bone and soft~     tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more~     than 75%.~      However, MRI is expensive and not rapidly accessible.~      Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam~     can be used to assess the presence and extent of inflammation, destruction, and tissue~     response.~      The objective is to describe, using ultrasonography, the abnormalities joint structure~     influenced the septic arthritis evolution and prognosis.~      The investigators hope, at the end of this study, to evaluate ultrasonography interest in~     septic arthritis and to establish ultrasonography prognosis factors to predict treatment~     efficiency and functional outcome.~   "
79339|NCT02018939|"~     The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF~     (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System)~     and intermittent hemodialysis.~   "
79340|NCT02018926|"~     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is~     a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate-~     or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the~     safety of the study treatment. Safety assessments will include echocardiograms,~     electrocardiograms and routine safety laboratory studies (hematology and serum chemistry).~     In addition, clinical response to treatment will be monitored using bone marrow aspirates or~     biopsies, and other routine methods.~   "
87042|NCT01918085|"~     The aim of the study is to investigate the correlation in peel force when peeling off a~     standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin~     compared to pre-stripped healthy abdominal skin in colostomists.~   "
79341|NCT02018913|"~     Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of dementia.~     Yet, the cause of these diseases is still unknown. A potentially important initiating factor~     is a disrupted blood-brain barrier. This can initiate cerebral microangiopathy, which has~     frequently been associated with VaD. Nevertheless, also in most AD patients a substantial~     increase of vascular damage has been observed. The present study investigates the~     correlation between blood-brain-barrier breakdown and cognitive decline in AD and VaD. An~     innovative dynamic contrast-enhanced MRI scan that has recently been developed and tested at~     our institute, will be used to measure blood-brain barrier permeability.~      Objective: We will investigate the relationship between this permeability measure and (i)~     cognitive performance and (ii) the status of MRI visible cerebrovascular pathology (i.e.~     white matter hyperintensities, lacunar infarctions, microbleeds) in the most common forms of~     dementia.~   "
79342|NCT02018900|"~     In the present pilot study, the investigators will study the effects of a novel synbiotic,~     which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain~     fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the~     gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that~     the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and~     modulate the immune system in humans.~   "
79343|NCT02018887|"~     The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it~     causes any side effects. The study will also measure how much of the study drug gets into~     the blood stream and how long it takes the body to get rid of the study drug. This is the~     first time that this study drug is being given to participants. This study is for research~     purposes only and is not intended to treat any medical condition.~   "
79344|NCT02018874|"~     In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a~     high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown~     synergistic activity in combination with targeted agents or chemotherapy including~     gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different~     tumor types with molecular alterations. This may validate the anti-tumor activity of the~     LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.~   "
79345|NCT02018861|"~     Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to~     find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor,~     INCB050465, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1~     inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. INCB050465~     inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.~   "
79346|NCT02018848|"~     The goal of this study is to investigate an attention training program for participants with~     Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task~     with picture stimuli related to washing and checking paired with neutral pictures.~      Participants are randomly assigned to an experimental and a placebo-control group. After a~     minimum of 4 weeks of attention training we expect to find differences between participants~     of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety~     and depression.~   "
79347|NCT02018835|"~     Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the~     stress of exercise may offer early diagnostic indicators in patients suffering from valvular~     disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining~     importance in providing prognosis among those patients. However, decreased signal to noise~     ratio in the images and increased motion-related artifacts during exercise stress~     echocardiography have been reported, with a lack of reproducibility of results and a the~     limitation of its availability only in reference centers. In our laboratory, we are able to~     perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end~     of the patient table, previously described in healthy volunteers.~      The first aim of our study is to demonstrate the safety and the feasibility of our MRI~     protocol in selected patients with asymptomatic severe organic mitral regurgitation, to~     assess left ventricular volumes and function, and regurgitant volume in comparison to~     exercise cardiac echography.~      Besides, few recent studies sustain the relevance of novel markers of central aortic~     function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to~     explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness~     is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation~     of aortic stiffness would be useful for risk assessment and preventive follow-up strategies~     in young asymptomatic relatives of subjects with aortic inherited diseases, such as~     syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection.~     Furthermore, this technique should be able to evaluate the effect of drugs on aortic~     stiffness change in trials, before and after drug therapy, more relevant than the classic~     change in aortic diameter measurement.~      The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate~     local and regional heterogeneity in aortic functional parameters (distensibility, compliance~     and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by~     MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and~     to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave~     velocity estimation by applanation tonometry.~   "
79348|NCT02018822|"~     This double blind randomized controlled prospective clinical trial will compare the clinical~     success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply~     Caulk) and an experimental urethane dimethacrylate resin based composite resin (Dentsply~     Caulk) for wear resistance, staining and marginal seal using modified Ryge criteria to~     evaluate the posterior restorations for 24 months in duration~   "
79349|NCT02018809|"~     To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence~     Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by~     an electronic pill bottle.~      Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest~     statin adherence of any arm, as measured by pill bottle data.~   "
79350|NCT02018796|"~     The study will be conducted in 4 sites and will examine how a simplified outpatient medical~     abortion procedure using mifepristone and misoprostol, with the option to take mifepristone~     at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate~     the efficacy of oral administration of 200 mg mifepristone and sublingual administration of~     600 µg misoprostol with gestations through 70 days, as well as the acceptability of this~     method. Research questions include:~        1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later~          by 600 µg sublingual misoprostol and used in gestations of up to 70 days?~        2. Is medical abortion procedure consisting of two visits acceptable to women in~          Kazakhstan?~        3. Are the side effects associated with sublingual use of misoprostol acceptable to women?~        4. When given a choice, do women prefer to take mifepristone in the clinic or at a place~          of their choosing?~   "
87112|NCT01917175|"~     Set-up of a biobank for patients with an estimated date of infection seroconverters: store~     plasma and cells samples at initial contact and during follow-up for future analysis and~     analysis in international collaborative cohort seroconverters.~   "
79351|NCT02018783|"~     The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for~     immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One~     hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups~     according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate~     and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate~     nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according~     to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at~     baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests~     were used to assess the sensitivity level.~   "
79352|NCT02018770|"~     The present study aims to evaluate the effect of phototherapy with the combination of~     different sources of light on pain, activity of temporal and masseter muscles, bilateral and~     joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and~     double-blind clinical trial. Individuals participate with myogenic temporomandibular~     disorder, being allocated into 4 groups randomly and stratified by the method of sealed~     envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography,~     and visual analog scale and algometry. The protocols will be used in a single session and~     will be evaluated in four different moments. The variables that will be investigated are~     pain, muscle activity and joint mobility. The analyses of the data will be performed by~     adopting a significance level of 5%.~   "
79353|NCT02018757|"~     The purpose of the study is to determine whether transarterial chemoembolization containing~     arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular~     carcinoma.~   "
79354|NCT02018744|"~     This registry has been designed as a multicenter, single arm, open label, post-market~     registry study with consecutive, eligible patient enrollment at each site. All subjects~     undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects~     will be followed up to discharge discharge, and as per institutional standard of care~     thereafter through to 5 years (total follow-up commitment). This registry of the Nellix~     System, which has received the market authorization of the European Union (Conformité~     Européenne, CE-certification) in a real world patient population treated in a multicenter~     setting will provide an assessment of the generalizability of the approach and System.~      Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered~     candidates for Endovascular Repair, in up to 30 international centers will be enrolled in~     the study.~   "
79355|NCT02018731|"~     The purpose of the study is to compare the effects of L-citrulline and metformin and their~     combination therapy on muscle function and force in patients with Becker muscular dystrophy~     (BMD).~   "
79356|NCT02018718|"~     The aim of this study is to demonstrate and quantify the micro architecture and micro~     vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and~     arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow~     parameters will be registered before and after the long-distance run on the lower leg. Axial~     T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and~     inflammatory markers will be collected in blood and urine samples and compare with both MRI~     and Near-infrared spectroscopy (NIRS).~   "
79357|NCT02018705|"~     For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an~     endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM).~     Studies show promising short and mid term results for POEM. At present, POEM is considered a~     promising new technique with the potential to become a standard achalasia treatment. For~     this to happen, long-term comparative data with LHM is required. Therefore,the intention for~     this study is to investigate the short and long-term efficacy of POEM for the treatment of~     achalasia as it was performed in international centers and compare outcomes with database~     assessment of LHM.~   "
79358|NCT02018692|"~     The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is~     effective in the treatment of retinitis pigmentosa in adolescent patients.~   "
79359|NCT02018679|"~     Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as~     an alternatively attractive procedure for BCC. Er:YAG ablative fractional laser (AFL)~     treatment removes the stratum corneum to increase MAL uptake and may improve efficacy.~     However, no studies have directly compared the efficacy of Er:YAG AFL-PDT and MAL-PDT in~     treating nodular BCC in Asians.~   "
79360|NCT02018666|"~     This is a multicenter, prospective, randomized, open-label study which compared two~     ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter~     is considered as the reference ventilatory mode) in patients admitted to the ICU for acute~     respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize~     patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous~     ventilation.~   "
79361|NCT02018653|"~     The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can~     help to stop your diarrhea. Researchers also want to know if this drug can help decrease the~     duration of your diarrhea.~      In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like~     the study drug but it is not designed to treat any disease or illness. It is designed in~     this study to be compared with the study drug to learn if the study drug has any real~     effect.~   "
79362|NCT02018640|"~     Use of tobacco is very high among Alaska Native pregnant women. The investigators are~     conducting a three phase study. The first study is nearly completed and involved measuring~     biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a~     qualitative study to translate the biomarker findings to an intervention.~   "
79363|NCT02018627|"~     This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris~     Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs.~     micro-doses of Glucagon for Injection (Eli Lilly).~   "
79442|NCT02017600|"~     Investigator will assign 53 patients who had been histologically proven localized squamous~     cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2~     on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every~     3 weeks for 2 cycles and then followed by surgical resection. The successful rate of~     complete treatment per protocol and complete resection will be the primary variant to~     evaluate in our study.~   "
87113|NCT01917162|"~     The purpose of this study is to compare the subjective performance of two daily disposable~     contact lenses with respect to comfort and handling.~   "
79364|NCT02018614|"~     Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is~     frequent and underestimated, especially when these patients have cognitive disorders. The~     expression of pain is then modified and the conventional tools for evaluating pain cannot be~     used. Thus the existence of pain must be detected on the basis of a behavioural assessment.~      It is nonetheless necessary to have the assistance of standardised and validated tools. In~     France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999,~     and is now proposing a new scale for acute pain, Algoplus that has been validated in French~     (4). Doloplus has been recently translated and validated in 5 languages and an identical~     methodology will be used in this protocol.~      Internationally, although several teams are working on the development of scales that can be~     used for non-communicating elderly subjects, there is as yet no validated tool for acute~     pain assessment.~      Considering 1- the lack of tools at an international level and 2- the frequent request from~     many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale~     in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous~     methodology with the help of a statistician will be used in this validation process.~   "
79365|NCT02018601|"~     The main objectives of the trial are the efficacy and safety of intercostal nerve block in~     the midaxillary line versus paravertebral block, both guided by ultrasound in patients~     scheduled for not reconstructive breast surgery.~   "
79366|NCT02018588|"~     Our objective is to determine the requirement for the amino acid tryptophan in school age~     children using the indicator amino acid technique.~   "
79367|NCT02018575|"~     Our objective is to determine the metabolic availability of Lysine in white maize using the~     indicator amino acid oxidation (IAAO) technique in adult men.~   "
79368|NCT02018562|"~     Verbal communication is vital to critically ill mechanically ventilated patient's quality of~     life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a~     speaking valve, however, some patients may not be able to tolerate cuff deflation for use of~     speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to~     facilitate speech in this population. Unfortunately, not all candidates are offered these~     options due to lack of awareness. Recently, at our institution, there has been an increase~     in the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that~     has proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA).~      In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy~     helped facilitate communication in this unique population (IRB #: NA_00041547). We would now~     like to formally conduct a prospective pilot study to evaluate the feasibility of measuring~     outcomes of patients with a BLUSA using a pretest-posttest research design.~      Communication empowers patients and allows healthcare staff to obtain a more accurate~     assessment of patients' condition and tailor care accordingly. Identifying the predictors of~     speech intelligibility and the impact of BLUSA on quality of life will promote communication~     between patients and healthcare providers.~      Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in~     patients requiring prolonged mechanical ventilation in the hospital.~   "
79369|NCT02018549|"~     Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile~     through the NEXThaler device in adult COPD patients with varying degrees of airflow~     limitation~   "
79370|NCT02018536|"~     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic~     (what the body does to a medication) of GSK2336805 alone and with the co-administration of~     TMC435 in healthy Japanese participants.~   "
79371|NCT02018523|"~     The purpose of this study is to investigate the safety and efficacy of maintenance therapy~     with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer~     (NSCLC) after first line chemotherapy. Investigators expect this treatment approach will~     delay disease progression by boosting the patient's anti-tumor immune response.~     Investigators hypothesize that 10 mg/day of lenalidomide can be administered safely as~     maintenance therapy and improve progression free survival time.~   "
79372|NCT02018510|"~     The proposed study is a first-in-man phase I study that aims to evaluate the safety,~     tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects,~     and its antiretroviral activity in HIV-infected subjects.~   "
79373|NCT02018497|"~     The essential arterial hypotension and adaptation registry is an observational, prospective,~     cohort type, descriptive and comparative research about the low arterial blood pressure with~     no identifiable cause, in a population that visits a cardiologist's office in Medellin,~     Colombia.~      The population consists of patients of any age and gender, which are classified according to~     their blood pressure in: normotensive, hypertensive and hypotensive. In addition, they are~     also classified in hypo, normal and hyper adaptation.~      The aim is to evaluate how clinical, laboratory, paraclinical examinations and certain~     comorbidities behave between the three groups of blood pressure and adaptation in order to~     define the meaning of the essential hypotension and the adaptation and propose possible~     mechanisms mediating this relationship.~      HYPOTHESIS Causes of the diseases are multifactorial.~      A person´s health depends on their biological and physiologic systems, their external~     environment and circumstances, and their interaction or relationship between them.~      The organism´s response to stress or allostatic load involves a network of epigenetics~     mechanisms, neuroplasticity; autonomic nervous, the endocrine and the immune systems.~      When you move any part of the network, the whole network moves. Everything connects~     ultimately to every thing else. Any part of the network can be the prime mover, and be cause~     of the rest of the network moving, and adjusting to the tension. It is networks that are~     dynamically functional.~      This registry proposed that the individual's response to stress is not homogenous in the~     population, it may be: excessive, proportioned and deficient, and may contribute decisively~     to produce essential blood pressure disorders, excessive adaptation producing high BP and~     deficient low blood pressure.~      Arterial blood pressure would be an indicator of the individual's adaptation pattern to~     stress, and the comorbidities in each blood pressure group would be part of the same~     response pattern.~      The concept of essential: diseases afflicting an important mass of the population may be the~     result of the body's response to stress, in an attempt to maintain homeostasis. It is~     postulated that both the magnitude and direction of this response must have a distribution~     that is between one and two standard deviations of the Gaussian curve, probably more or less~     than others.~      The concept of psychobiotype: The homeostasis is the result of both: biological (biostasis)~     and psychological (psychostasis) abilities. This concept proposed that both components~     behave in similar direction and magnitude.~      Immune disorders may be associated with the development of cancer. High blood pressure~     population has a higher sympathetic and lower vagal tone, this have been associated with a~     decrease in the immune system function.~   "
79443|NCT02017587|"~     The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from~     approximately 40 chronic HBV for biomedical research program led by VGTI Florida.~   "
79651|NCT02014870|"~     The primary objective is to determine the dose level of live, wild-type A/California/ H1N1~     2009 virus that has an appropriate safety and illness/infectivity profile to be used as an~     influenza virus, challenge strain in future intervention studies.~      Illness parameters were collected by subject symptom scores as well as by physical~     examination. Virus parameters were measured by PCR and cell culture assay (performed by~     VisMederi srl).~   "
79374|NCT02018484|"~     Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of~     the knee especially when it affects only the medial femoro-tibial compartment. To place the~     prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence~     the position of the different elements of the prosthesis and the limb alignment. It is known~     that good positioning of the prosthesis is the key of a good survival of the implants. To~     guide the blade of the saw, cutting guides are used. The position of these guides gives the~     final position of the cuts. At present, two main techniques are used to position the guides:~     the conventional one, not very costly but not very accurate, and the navigated procedure,~     which is more accurate but also more expensive and more invasive. Since few years, patient~     specific cutting guides are used in total knee replacement with encouraging results and more~     recently in uni compartmental knee replacement with no scientific proof of efficiency.~      This study aims to validate the procedure of patient specific cutting guides.~   "
79375|NCT02018471|"~     Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can~     lead people to avoid screening tests, with high risks for health. A single arm, pilot study~     was organized to evaluate the feasibility and efficacy of psychological counselling for~     cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that~     taking part in Psychoeducative Training could offer a new modality to reduce anxiety, before~     and during tests, and also the possibility to reinforce coping strategies.~   "
79376|NCT02018458|"~     The primary objective of this study is to determine the safety and feasibility of combining~     cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy.~      The secondary objectives of this trial are to determine pathologic complete response rates;~     disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell~     immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients~     receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2-~     BC patients with patient-specific tumor antigens.~   "
79377|NCT02018445|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion,~     as compared to local autograft.~   "
79378|NCT02018432|"~     Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache,~     diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild~     or moderate. They occurred mainly at the beginning of therapy and mostly resolved with~     continued treatment around for two weeks according to experiences of clinicians. These~     adverse events occur more often in Roflumilast 500 μg than 250 μg, having negative impact on~     compliance of patients at the early stage of treatments.~      Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast~     500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and~     then escalating dose of 500 μg once daily).~   "
79379|NCT02018419|"~     This phase I/II study is designed to compare different treatment schedules of a personalized~     anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion~     with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific~     antigens into the surrounding environment. The injection of bioengineered allogeneic immune~     cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate~     the immune system to kill other tumor cells.~   "
79380|NCT02018406|"~     The purpose of our study is to determine the safety and efficacy of the combination of~     erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with~     neurological diseases. To be specific, our clinical study is expected that the combination~     injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating~     endogenous repair process in patients with neurological diseases including stroke, cerebral~     palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique~     in patients with neurological diseases, which is expected to overcome current ethical and~     technical limitations of less evidenced functional recovery, hematological changes, and side~     effects. Eventually, We will establish a comprehensive clinical background about~     neurotrophic and neuroprotective effects of this hematopoietic growth factors therapy.~   "
79381|NCT02018393|"~     This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe~     haemophilia A and inhibitors.~   "
79382|NCT02018380|"~     Osteoarthritis (OA) is a progressive, chronic disease affecting more than 20 million~     Americans. There is no known cure for OA and management includes pain control and prevention~     of functional decline.~      Purpose: To investigate the immediate effects of a shock absorbing insole (SAI) placed in~     the shoe on knee pain, functional mobility and lower extremity biomechanics.~   "
79383|NCT02018367|"~     The overall goal of the study is to determine whether imaging with the low-cost High~     Resolution Microendoscope(HRME) will increase the efficiency and yield of the current~     standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide~     an in-vivo optical biopsy that will be comparable to gold standard histopathology and~     allow the endoscopist to make a more informed decision about whether to obtain a biopsy or~     even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).~   "
79384|NCT02018354|"~     The purpose of this study is to compare outcomes (failure, function, strength, range of~     motion and quality of life) between patients who receive the usual anterior cruciate~     ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament~     reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the~     outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in~     young individuals who return to pivoting contact sports following ACL reconstruction. This~     study is designed to look at whether or not adding this extra tendon repair reduces the risk~     of graft failure in this population.~   "
79464|NCT02017314|"~     The aim of the study is to observe if any correlation between Body mass index and VAS values~     exists in patients who has gone under abdominal surgery.~      Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III:~     Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group~     V : Patients with BMI >50~      After the end of surgery patients will be extubated and in the recovery room morphine PCA~     (patient-controlled analgesia) treatment will be started according to their adjusted body~     weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment.~     VAS values and Delivery and Demand of the PCA and additional need for analgesics will be~     recorded in the first 48 hours.~   "
79385|NCT02018341|"~     A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be~     carried out on 30 healthy adult volunteers. The remedy used for the proving will be~     administered in a potency of 30C. The remedy being used is a common homeopathic remedy~     commercially available in the US, but the exact remedy is not disclosed to participants.The~     purpose of the proving is twofold: 1) to determine if there is a difference in symptoms~     between those receiving an active versus placebo medicine, and 2) to see if there is a~     difference in gene expression between those who receive the homeopathic remedy or placebo.~     It is hypothesized that participants receiving the active medication will have more symptoms~     characteristic of the remedy and have specific patterns of gene expression in whole blood~     that are different from those in placebo recipients. Participants will record symptoms in a~     diary for 3 days prior to administration of study medications, during 3 day of its~     administration and for 3 days following completion of the study medication. Blood will be~     drawn for gene expression studies on the day that the study medication is started and again~     after taking the study medication for approximately 48 hours. An additional, optional blood~     draw for possible future analysis of gene expression will be done at the end of the study~     period.~   "
79386|NCT02018328|"~     Background and Aims~        -  H.pylori is a common human pathogen by which almost 50% of the world population is~          infected. According to the accepted guidelines, once H.pylori infection has been~          diagnosed,first line therapy with three drugs should be given. The triple treatment~          includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is~          only 70-80%.~        -  Curcumin has many beneficial merits and it was also been demonstrated to be efficient~          in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether~          addition of Curcumin to the standard triple therapy will increase the eradication rate~          of H.pylori infection.~      Methods~        -  150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology~          department and will be positive for H.pylori according to urease test and then by~          gastric biopsy, will be included. The patients will be randomized to two different~          treatments, according to binomial distribution. 75 patients will be treated with the~          standard triple therapy for 10 days and the other 75, will be treated for 10 days, with~          triple therapy combined with Curcumin that will be given three times a day.~        -  During the treatment the patients will complete an adverse effect's questionnaires. 6~          weeks after the completion of the treatment the patients will undergo urea breath test~          to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds~          or proton-pump-inhibitor until the second urea-breath-test.~        -  We will compare the eradication rate and the adverse effects between the two groups by~          using SPSS~   "
79387|NCT02018315|"~     The purpose of this trial is to determine if an alternative energy source will impact brain~     metabolism in a disorder characterized by glucose metabolism failure in the brain.~      The central hypothesis tested in this investigation is whether circumventing impaired~     glucose metabolism is feasible, safe and potentially promising by supplying anaplerotic~     precursors through metabolism of odd-carbon fatty acids that can enter the citric acid cycle~     (CAC) through alternative metabolic pathways.~   "
79388|NCT02018302|"~     This protocol provides ongoing access to triheptanoin for patients who did complete an~     initial pilot protocol, and provides the opportunity to collect long-term safety data from~     patients treated with triheptanoin.~   "
79389|NCT02018289|"~     The abdominal closure with triclosan coated suture will reduce superficial surgical site~     infection.~   "
79390|NCT02018276|"~     Studies have attempted to control pain and increase patients' recovery satisfaction~     following many kinds of operations by using as small an opioid analgesic dose as possible~     and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among~     nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be~     helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical~     stimuli. Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An~     intraoperative intravenous injection of lidocaine has been reported to improve postoperative~     pain control by reducing postoperative pain and opioid consumption. Another report showed~     that an intraoperative intravenous injection of lidocaine improved the quality of~     postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy~     patient. In addition, a review article on the effect of intraoperative intravenous injection~     of magnesium found it to be an effective analgesic that may be added to conventional~     opioid-based therapy because it generally reduces opioid consumption, decreases pain~     assessment for 24 hours after surgery, and lacks severe side effects in relation to~     magnesium administration. However, there has been insufficient research comparing the~     intraoperative intravenous injection of lidocaine or magnesium in terms of which is more~     helpful for general functional recovery and decreased postoperative pain. Recently, the~     scope of research on anesthesia has come to embrace postanesthetic recovery; to help~     patients return to daily life, the research trend is now shifting from the improvement or~     resolution of a specific symptom to the measurement of general recovery. Postoperative~     recovery is a complicated process related to such catamnestic factors as physiological~     end-points, the incidence of adverse events, and changes in psychological status. A widely~     used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.~     The QoR-40 includes a total of 40 questions that may be divided into five sub-categories:~     emotional state, physical comfort, psychological support, physical independence, and pain.~     The respondent answers each question on a 5-point scale, with one being worst and five being~     best. The QoR-40 takes 6.3 minutes on average to complete and is known to have good~     test-retest reliability, internal consistency, and split-half reliability. With respect to~     anesthetic recovery, the QoR-40 has been used in various studies to investigate how the~     surgery type, anesthesia method, administration of an additional drug, and gender affect~     anesthesia and surgery. The validity of the QoR-40 for research purposes has already been~     established.~      Therefore, in this study, we investigated the intraoperative intravenous injection of~     lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in~     the functional recovery of thyroidectomy patients after general anesthesia.~   "
79391|NCT02018263|"~     This study looks to explore the feasibility, sensitivity, validity, and specificity of a~     Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication~     in the inpatient human laboratory, as well as in the outpatient setting (real world).~     Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world~     settings and inference techniques for understanding the relationship between cocaine use and~     user contexts.~   "
79392|NCT02018250|"~     This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety~     when delivered intramuscularly (i.m.) to the anterior thigh.~   "
79393|NCT02018237|"~     The purpose of this research study is to learn more about how high fructose corn syrup, a~     sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without~     nonalcoholic fatty liver disease. Eligible participants will be studied before and after~     eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn~     syrup) for four weeks.~   "
79981|NCT02010541|"~     The first purpose of this study is to is to compare metabolic control of type 1 diabetes~     among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose~     sensor, and children who use only insulin pump; the investigators will also determine~     dietary habits, their knowledge of type 1 diabetes management and emotional aspects of~     experiencing illness in the family, in both groups of children.~   "
79394|NCT02018224|"~     The intention is to compare 60 patients with Achilles tendon rupture, who where randomized~     in 1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop~     technique either without augmentation or with one central down-turned gastrocnemius fascia~     flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free~     active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to~     neutral for the first three weeks. Weight bearing was limited for six weeks. To compare~     these treatments, we use 1998 published Leppilahti-score, Rand-36 quality of~     life-questionnaire and MRI. Mean follow-up time is 14 years.~      Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide~     better result than would end-to-end suture repair with use of the Krackow locking loop~     surgical technique in long-term follow up.~   "
79395|NCT02018211|"~     Numerous techniques are reported to enhance recovery following intense exercise, however~     there is equivocal support for such claims. A novel technique of neuromuscular electrical~     stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which~     could enhance recovery following exercise. The present study examined the effects of NMES,~     compared to graduated compression socks on muscle soreness, strength, and markers of muscle~     damage and inflammation following intense intermittent exercise.~   "
79396|NCT02018198|"~     The purpose of this study is to investigate FebriDx, a point-of-care, non-invasive, rapid~     diagnostic test, at identifying an immune response to viral and bacterial infection related~     to an acute community acquired febrile upper respiratory infection, as compared to expert~     clinical reviewers' evaluation in conjunction with the results of clinical standardized~     microbiologic and laboratory testing.~   "
79397|NCT02018185|"~     In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial~     prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This~     study revealed considerable benefit in using rTMS for the treatment of OCD.~      In the current proposal, in a randomized clinical trial, the investigators aim to further~     evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period.~     Studies into the efficacy of rTMS in other psychiatric disorders such as depression have~     consistently shown that extension of the treatment to four weeks significantly increased the~     effect size. In the pilot study, the investigators applied rTMS for only two weeks. Although~     all patients consistently showed improvement in their symptoms, none of them showed complete~     remission of their OCD. Here, the investigators hypothesize that longer duration of rTMS~     treatment will have greater benefit in OCD symptom reduction.~   "
79398|NCT02018172|"~     The study is performed to collect long-term data on the treatment adherence and patient's~     acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in~     patients with a growth hormone deficiency or Turner's syndrome.~   "
79399|NCT02018159|"~     This post-marketing, multi-center prospective study will be conducted in a open-label,~     non-interventional setting, for women seeking fertility treatment and will describe~     morphokinetic de-selection parameters in human embryos.~   "
79400|NCT02018146|"~     Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing~     general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask~     ventilation allowing for better oxygenation during the induction phase of general~     anesthesia. Oxygenation may be maintained better in case of difficult mask ventilation. This~     study evaluates this alternative method in comparison with the standard method of mask~     ventilation.~      General Design This is a randomized, controlled, cross over study. Patients will be~     randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation~     or vice versa.~      Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed~     ETT is superior in its efficacy (as measured by tidal volume) to routine facemask~     ventilation in patients undergoing general anesthesia and endotracheal intubation for their~     surgery.~   "
79401|NCT02018133|"~     The purpose of this study is to identify genes that are responsive to paricalcitol (active~     vitamin D) therapy. Scientists have found that over 30 different types of cells in the body~     respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce~     the amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and~     cause the parathyroid gland (small gland located in the neck) to get bigger which is called~     secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart~     disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a~     replacement for vitamin D for preventing and treating SHPT. Studies that followed patients~     on dialysis have found: (1) differences in death rates between those who received active~     vitamin D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney~     disease (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D).~     Researchers have considered that giving paricalcitol to people with (CKD) may also prevent~     or slow the progression of heart disease.~      Currently, physicians can only tell how well the vitamin D is working by measuring PTH~     concentrations. This study aims to identify markers in the blood that can be used to~     determine the efficacy of Vitamin D therapy.~   "
79402|NCT02018120|"~     The aim of this randomized controlled clinical study is to evaluate and compare the~     effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of~     multiple gingival recessions.~   "
79403|NCT02018107|"~     In this research study, the investigators are evaluating whether ammonia PET scans are more~     useful in helping radiologists determine whether liver tumors were successfully destroyed by~     the heating or freezing procedures (ablations) than other scans currently available to~     radiologists, such as CT scans and MRI scans.~      The currently available scan (usually a CT scan with contrast dye) is not always effective~     in showing how completely the tumor has been destroyed. The ammonia PET scan is a different~     way of looking at how much tumor has been destroyed. This study will compare the standard~     scan (CT scan) with the ammonia PET scan.~   "
79465|NCT02017301|"~     Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often~     present with malnutrition, and due to the in-hospital stay, their nutritional intake can~     vary widely, with several periods of fasting, and sometimes insufficient nutritional~     support. Therefore patients are prone to develop malnutrition or, the already present~     malnutrition worsens its status.~      Our aim is to evaluate the daily changes in nutritional status in patients with acute~     decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.~   "
79404|NCT02018094|"~     -  Lower limb amputations are performed usually as a last resort in patients with acute~          and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes~          or, infection.~        -  In the period 2003-2008 there were approximately 5,000 amputations per year in the UK.~        -  The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection~          within 30 days of an operation or up to one year if an implant is left in place and the~          infection is related to an operative procedure.~        -  Figures from the Surgical Site Infection Surveillance reported that the highest rate of~          surgical site infection was reported in association with lower limb amputation at~          13.1%.~        -  There is a clear under-representation and the infection rate within our institution is~          approximately 25% which reflects the infection rate reported in a recent trial by Sadat~          et al (22.5%)~        -  Prevention of surgical site infections is of paramount importance to patients,~          healthcare providers and policy-makers, as they impact on morbidity and mortality and~          have significant time and cost implications.~        -  Currently there is NO CONSENSUS as to what the best practice is towards antibiotic~          administration in such patients. From a questionnaire-based audit we performed~          including vascular departments across the entire country, practice varies in both~          course duration (single dose → 5 days antibiotic course) as well as choice of~          antibiotics.~        -  The guideline at our institution suggests the 5-day course of antibiotic prophylaxis.~          The course duration varies depending on the clinical picture as well as microbiology~          results and recommendations.~        -  There are no randomised control trials that have investigated this aspect of patient~          care. We have set up one such trial and through it, we are looking to establish a~          standard practice which will hopefully be as beneficial as possible to the patient but~          also cost-effective for NHS.~   "
79405|NCT02018081|"~     The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients~     suffering from pneumonia with taking into account physio-pathological parameters. 2. to~     verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory~     Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory~     Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this~     study.~   "
79406|NCT02018068|"~     Perineural injection of local anesthesic is currently the reference method for the treatment~     of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain~     is a dynamic phenomena in every patient. It is classified as intense during the first~     postoperative hours after surgery, and decreases in a non-linear manner over the days~     following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows~     an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a~     decrease in adverse events related to the continuous infusion technique (motor or sensory~     blockade, paresthesia, etc.). The physician can also modify the pump settings according to~     the postoperative rehabilitation plan.The use of new communication techniques such as~     telemedecine may be of interest in reducing treatment onset time and optimizing pain~     management. The remote control consists to change the settings of the pump after if the~     anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain~     level, sensory and motor blockades. The physician goes to a dedicated website (Micrel~     CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio~     Service) connexion. The aim of this prospective, comparative, multicentric trial is to~     compare the effectiveness of patient management through two communication modalities: remote~     control versus bedside care.~   "
79407|NCT02018055|"~     The purpose of this study is to evaluate the efficacy and safety of clopidogrel in~     stabilized patients with acute myocardial infarction (AMI) who performed percutaneous~     coronary intervention (PCI) with drug-eluting stents (DES) compared with ticagrelor.~      In this study, 3,288 patients with AMI who underwent PCI with DES and took dual antiplatelet~     therapy as aspirin and ticagrelor during 1 month from index PCI will be randomized to~     aspirin and ticagrelor versus aspirin and clopidogrel during 11 months.~   "
79408|NCT02018042|"~     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune~     disease. In this disease, the immune system mistakenly destroys the hair follicle, causing~     hair to fall out. Despite many people having this disease, research into its cause and into~     new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of~     the immune system. Currently, there are no Federal Drug Administration approved drugs for~     Alopecia Areata.~      Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat~     rheumatoid arthritis, another autoimmune disease, by fighting inflammation. There are some~     genetic and chemical similarities between those with active rheumatoid arthritis and~     Alopecia Areata, suggesting that treatment with the same drug is likely to be effective. In~     mice specially designed for testing drugs for the treatment of human alopecia, this~     medication worked to prevent the disease Alopecia Areata from starting.~      To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata~     for 6 months. Each person enrolling into this study will receive the active study drug. The~     effectiveness of the medication will be measured by changes in hair re-growth as determined~     by physical exam and photography, as well as by patient and physician scoring. Patients will~     be followed for another 6 months off of the drug to see if the effects of treatment last and~     if there is delayed response. We have recently changed the study to allow testing of~     abatacept in a few patients with alopecia totalis and universalis.~      Small scalp biopsies and peripheral blood will be taken at the beginning of the study before~     treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and~     blood will help us to understand how the disease happens, how the treatment works, and~     perhaps even guide us to better treatments in the future.~   "
79409|NCT02018029|"~     Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in~     patients with refractory symptomatic chronic heart failure with reduced ejection fraction~     (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically~     ameliorated. They are called the non responders. Patient selection seams to be one of the~     key to improve the efficiency of CRT. This protocol try to assess positive predictive~     factors to CRT by a multimodal approach.~   "
79410|NCT02018016|"~     Background~      Appendicitis is a common condition which represents a significant resource burden for the~     Scottish National Health Service (NHS). It is unknown whether there are significant~     differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by~     hospital volume. In many studies, hospital procedural volume has been shown to be predictive~     of surgical outcomes.~      Aims~      The aim of this study is to compare appendicectomy outcomes in Scotland as they vary by~     hospital procedural volume.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a procedure codes for appendicectomy. A 10~     year period will be studied, from January 2001 to December 2010.~      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day~     readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.~   "
79411|NCT02018003|"~     The purpose of this study is to assess the women's quality of life, who accepted~     chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after~     operation.~   "
79412|NCT02017990|"~     This study will evaluate the association between n-3 polyunsaturated fatty acids and patient~     and graft survival. The association between other fatty acids and mortality and graft loss~     endpoints will also be evaluated.~   "
91372|NCT01861223|"~     To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to~     gefitinib or erlotinib.~   "
79413|NCT02017977|"~     Introduction~      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which~     are known to carry a significant risk of mortality and morbidity. Previous work has shown~     considerable inter-hospital variation in emergency laparotomy outcomes within the United~     Kingdom. It is unknown whether there are significant differences in outcomes following~     laparotomy which may be explained by geographic factors.~      Aims~      The aim of this study is to describe emergency laparotomy outcomes in Scotland as they vary~     by the urban-rural nature of the patient's home location and travel time from hospital.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a set of procedure codes for emergency~     laparotomy, and the urban-rural classification of patients will be derived from postcode~     data. Travel time from hospital will also be derived from postcode data. The investigators~     will study a 10 year period from January 2001 to December 2010.~      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary~     outcome measures will be 30 day readmission rate, 30 day re-operation rate and~     post-operative length of stay.~   "
79414|NCT02017964|"~     This phase II trial studies how well combination chemotherapy works in treating younger~     patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in~     chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
79415|NCT02017951|"~     Introduction~      Appendicitis is a common condition which represents a significant resource burden for the~     Scottish National Health Service (NHS). It is unknown whether there are significant~     differences in outcomes following appendicectomy which may be explained by geographic~     factors.~      Aims~      The aim of this study is to describe appendicectomy outcomes in Scotland as they vary by the~     urban-rural nature of the patient's home location and travel time from hospital.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a procedure code for appendicectomy, and~     the urban-rural classification of patients will be derived from postcode data. Travel time~     from hospital will also be estimated through postcode data. The investigators will study a~     10 year period from January 2001 to December 2010.~      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day~     readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy~     rates.~   "
79416|NCT02017938|"~     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD).~     Past researches indicated that more than half of the individuals with PD demonstrated~     fatigue symptom. The severity of fatigue was also correlated to the quality of life in~     individuals with PD. Finding the contributions of the central and the peripheral factors to~     fatigue, building reliable fatigue indexes, and developing an effective training program for~     individuals with PD are very important.~      The purpose of this project is to develop non-invasive method to monitor central and~     peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training~     paradigm, and to evaluate the long term training effect in individuals with PD.~   "
79417|NCT02017925|"~     This randomized clinical trial studies pulmonary rehabilitation in improving lung function~     in patients with locally advanced non-small cell lung cancer undergoing chemoradiation.~     Individualized exercise rehabilitation programs may reduce breathing problems and improve~     quality of life in patients with non-small cell lung cancer. It is not yet known whether~     pulmonary rehabilitation is more effective when started during or after cancer treatment.~   "
79418|NCT02017912|"~     This is a multi-center, randomized, double blind, placebo controlled study to evaluate the~     safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting~     Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .~      MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver~     Neurotrophic factors, which are potent survival factors for neurons, directly to the site of~     damage.~   "
79419|NCT02017899|"~     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of~     5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB~     vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at~     enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that~     of placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same~     concentration as study vaccine formulations. A total of 50 eligible subjects will be~     assigned to one of five sequential cohorts of 10 subjects each.~      Within each cohort, in an observer-blind fashion, subjects will be randomized to receive~     three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen~     concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive~     a summary of all safety data obtained during one week follow-up post-first vaccination with~     the lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board~     will make a recommendation, as to whether the next cohort should be vaccinated with higher~     antigen concentration or not.~      Expected duration of the study for an individual subject is 9 months. Each subject will be~     followed-up for 6 months after the 3rd vaccination.~   "
79420|NCT02017886|"~     To evaluate the effect of daily ingestion of the probiotic Lactobacillus reuteri on the~     levels of secretory IgA and the cytokines Il1-beta, IL-6, IL-8 and IL-10 in saliva of~     healthy young adults.~   "
79474|NCT02017184|"~     Soldiers are required to perform and maintain alertness in difficult environmental~     conditions. The sensor examined in this trail may indicate body core temperature elevation~     during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting~     and walking in thermoneutral and hot environments with two core temperature sensors. The~     results obtained from them will be compared.~   "
79652|NCT02014857|"~     Increased levels of cytokines in GCF have been demonstrated in smoker subjects with chronic~     periodontitis. It is not surprising that increased levels of inflammation associated~     molecules in GCF has been observed in smokers with periodontitis. However, it is not clear~     if smoking has an influence on these parameters in periodontally healthy individuals. In the~     present study, it has been hypothesized that smoking might affect the levels of GCF MMPs and~     growth factors in young adults with periodontal health.~   "
79421|NCT02017873|"~     The main objective of this study is to evaluate the effectiveness and longevity of color and~     Tooth sensitivity of patients undergoing home whitening peroxide 10% carbamide ( Whiteness~     Perfect , FGM , Joinville , Santa Catarina , Brazil) , and the relationship with the~     cigarette use for tooth whitening. They will be selected 120 patients with incisors darker~     than A2, higher plants will be divided into 2 groups per center (n = 30 ) , GE - Group~     Experimental ( smoking) and GC - Group Control ( non-smoking) . For the two groups will be~     used Carbamide peroxide 10% for 3 hours daily for a period of 3 weeks. Color will evaluated~     through the Vita Classical scale and Vita Easyshade Spectrophotometer in the periods: Home ,~     for tooth whitening (1st , 2nd and 3rd week) and post- whitening ( 1 week and 1 month , 2~     and 3 months). Patients recorded the perceived sensitivity through Numerical Analogue Scale~     (NRS ) with values from 0 to 4, where 0 = no sensation, 1 = mild, 2 = moderate, 3 = severe~     and 4 = significant , also in the Visual Analogue Scale (VAS ), with values from 0 to 10~     where 0 = 10 = severe tenderness and sensitivity. for color analysis will be made two-way~     ANOVA (group vs. treatment time ), being Over time the repeated measure ( α = 0.05). Test~     will be held on Tukey to contrast the average ( α = 0.05). The sensitivity will be evaluated~     by the Fisher exact test . It is expected that there is no difference on the effectiveness~     of home whitening and tooth sensitivity between smokers and nonsmokers.~   "
79422|NCT02017860|"~     The purpose of this study is to collect and assess long-term safety of everolimus in~     patients who are currently receiving everolimus treatment in a Novartis-sponsored, Oncology~     CD&MA study that has reached its study objectives, are not progressing on the current study~     treatment as defined by the parent protocol and are unable to access everolimus treatment~     outside of a clinical study. Parent studies eligible to participate in the roll-over study~     will be decided by Novartis. Investigator initiated trials (IITs) will not be included. The~     primary objective of the parent study must have been reached and the parent study must be in~     the process of being completed and reported.~   "
79423|NCT02017847|"~     Aim of this study is to identify intensity cut off points for physical activity in a~     population over the age of 70.~   "
79424|NCT02017834|"~     The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also~     indicate it may result in faster surgery. A recently published randomized study from our~     group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer~     any reduction in OR time. The present study investigates the utility of the harmonic scalpel~     in resections involving removal of oral cavity tissues as well as the neck. Oral cavity~     resections are especially prone to blood loss and we believe the harmonic scalpel will~     confer benefits in this type of surgery, potentially reducing the need for blood~     transfusion.~   "
79425|NCT02017821|"~     Physical health does not have a high priority in today's treatment of patients with~     substance use disorder (SUD) patients have a poor physical health not only due to injuries~     related to the substance abuse, but also because of the lifestyle that addiction causes.~     There are today few studies that provide information about SUD patients' physical health.~     One of the project's aims is to document the physical health of SUD patients in treatment,~     using objective measures. After completion of various physical tests, an 8 week period of~     high intensity aerobic training intervention will follow. It will be investigated if the SUD~     patients are able to engage and participate throughout the whole training intervention, to~     what degree the participants improve their physical health and the effect of physical health~     improvement on substance abuse treatment.~   "
79426|NCT02017808|"~     This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of~     the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients~     treated with GA and in healthy controls.~   "
79427|NCT02017795|"~     Objectives:~      The disease being studied is asthma. The main objective of this study is to assess the~     feasibility of the recruitment goals and also the logistical issues related to use of~     tele-health technology in developing electronic asthma action plan (eAAP) and communicate~     with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients~     to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene~     appropriately based on the patient's health status. The secondary objective is to explore~     the cost-benefit and cost-effectiveness of the proposed technology. Our research group~     proposes to complete a feasibility study, with an interim analysis for a formal power~     calculation and then acquire ethics to report these results and study design with~     anticipated publication prior to proceeding with a full randomized controlled trial to~     assess the efficacy of this intervention. The outcome measure will be assessed and data will~     be presented in a 24-month time frame.~      Aims and goals:~      The main aim of our proposed study is to assist asthma patients to practice asthma~     self-management at home that will eventually enable them to control their asthma, and~     specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed~     study is to improve patient health outcome via enhancing patient-physician interaction and~     using a more practical asthma action plan model (eAAP) that could be followed easily by the~     patient and their doctor.~      Our hypothesis is that asthma patients who have access to the electronic online action plan~     complimented by weekly text messages to reinforce adherence will have a reduced rate of~     asthma exacerbation. We further hypothesize that these subjects will have an improvement in~     secondary measures including quality of life, better asthma control and patient~     satisfaction. We also anticipate that such an approach in asthma management will be~     cost-effective as outlined below.~   "
79428|NCT02017782|"~     The aim of the study is to provide information which may help to improve the quality of the~     life of persons exposed to indoor environments in Danish dwellings.~      The experiment will document if dust and ozone contribute to deterioration of indoor air~     quality and to the occurrence of symptoms and health effects.~      The study is aimed at testing the hypothesis that the presence of ozone potentiate the~     health and comfort effects of dust exposure in the indoor environment.~      Testing this hypothesis will be based on the following questions:~      Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause~     unwanted health effects either by themselves or by interaction?~      If so, does the presence of ozone potentiate the expected irritative effects of dust?~      The challenge of these hypotheses will be made as a controlled experiment on humans in a~     climate chamber under controlled exposure conditions.~      This controlled human experiment should be able to substantiate the findings from the~     intervention studies.~      Furthermore, they ideally reflect something relevant to the general public and therefore~     should have maximum public appeal and application possibilities.~   "
79429|NCT02017769|"~     We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP~     in maintenance treatment with immunoglobulin~   "
79500|NCT02016846|"~     Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity.~     However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose~     metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will~     improve glucose metabolism in patients with high risk for diabetes morbidity, treated with~     glucocorticoids.~   "
79430|NCT02017756|"~     Stroke is the first and the fourth leading cause of death in the United States and China,~     respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major~     etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques~     occurring at the feeding arteries to brain (cerebral arteries) will be helpful for~     prevention of stroke.~      Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous~     studies have shown that these high risk lesions in different segments of cerebral arteries~     (intracranial and extracranial arteries) might be racially specific. It is reported that, in~     stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas~     atherosclerosis more frequently involves extracranial carotid arteries in American subjects.~     However, these findings are based on angiographic imaging approaches via measuring arterial~     luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion,~     namely positive remodeling during progression, measuring luminal stenosis will underestimate~     the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly~     suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.~      High resolution, black-blood magnetic resonance (MR) imaging has been widely used to~     accurately characterize carotid vulnerable plaque in the last two decades. The aim of using~     MR black-blood techniques is to suppress the blood signal (black) to enhance the signal~     contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has~     been achieved between MR imaging and histology in identification of plaque components, such~     as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is~     superior to computed tomography and ultrasound imaging techniques due to its advantages~     including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution,~     and multi-parametric image acquisition.~      The Investigators hypothesize that there are specific characteristics in carotid vulnerable~     plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and~     transient ischemic attack (TIA). This study seeks to investigate the characteristics of~     vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in~     patients with recent TIA or ischemic stroke.~      This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited~     from more than 10 different hospitals across China within 3 years. All patients will undergo~     MR imaging for brain and carotid arteries within two weeks after symptom onset. The~     prevalence of carotid vulnerable plaque and its correlations with brain ischemic lesions,~     traditional risk factors, and regional distribution of China will be determined.~   "
79431|NCT02017743|"~     This study is a multicenter post authorization observational study. Cancer patients~     diagnosed with non high risk VTE and are followed up in an outpatient setting will be~     treated with LMWH and the data will be recorded. Since this is an observational study there~     are no specific treatment protocols, i.e., patients will be treated according to the best~     investigator's criteria. Treatment protocol will be based on the routine treatment practice~     of the involved investigator. Patients to enroll will be cancer patients diagnosed for VTE~     and who are able to receive outpatient LMWH treatment. There will be no specific hypothesis~     to be tested.~   "
79432|NCT02017730|"~     The purpose of this study is to assess the safety and tolerability of a novel positron~     emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement~     of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this~     tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following~     oral administration of Bristol Myers Squibb (BMS)-986020.~   "
79433|NCT02017717|"~     The purpose of the study is to compare the efficacy and safety of nivolumab administered~     alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain~     cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab~     administered alone or in combination with ipilimumab in patients with different lines of GBM~     therapy.~   "
79434|NCT02017704|"~     This research is being done to compare the effectiveness of high dose endorectal~     brachytherapy (END-HDR) and the standard treatment option of chemoradiation with~     Capecitabine in the treatment of cancer of the lowest part of the bowel (rectum).~   "
79435|NCT02017691|"~     Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS~     5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery~     and respiratory support based on both measurements in preterm neonates during the first 15~     minutes after birth.~      Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who~     require respiratory support will be eligible for the study.~      Design: A prospective two-centre randomized controlled pilot feasibility study~      Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine~     non-invasive monitoring in the first minutes of resuscitation. In addition during the first~     15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2~     measurements will be used to guide supplemental oxygen support and respiratory support~     during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used~     to guide supplemental oxygen support and respiratory support during the first 15 minutes~     after birth.~      Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2~     measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm~     neonates during the first 15 minutes after birth~      Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or~     >90th centile.~   "
79436|NCT02017678|"~     This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of~     ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly~     IV infusions of JX-594 until radiographically determined progressive disease. Patients will~     be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or~     10 days after Dose 5. Patients will be monitored on study until evidence of progression or~     death or for 12 months post treatment.~   "
79437|NCT02017665|"~     Worldwide, central nervous system infections such as inflammation of brain (encephalitis),~     inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe~     infectious in origin result in significant illness and death and healthcare costs. Vast~     majority of central nervous system infections remain without an identifiable cause. There is~     also concern about new and emerging infections.~      This study thus intends to fill in the gaps in knowledge with regards to central nervous~     system infections in Singapore to give a thorough description of burden of causes of central~     nervous system infections and detection of outbreaks of new pathogens. Patients suspected of~     central nervous system infection will be recruited from 5 restructured Singapore hospitals~     and their blood and other clinical specimens will be sent for testing. Patients will also be~     followed up to assess long term outcomes and socio-economic costs of these infections. This~     will help clinicians, policymakers and public health officials in estimating financial and~     societal costs of CNs infections in Singapore.~   "
79438|NCT02017652|"~     CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue~     oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2)~     measurements. This monitor was recently FDA cleared for use on adult subjects.~   "
79439|NCT02017639|"~     Primary Objective:~      To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the~     pharmacokinetics of simvastatin in patients with rheumatoid arthritis~      Secondary Objective:~      To describe the safety and efficacy (exploratory) of sarilumab~   "
79444|NCT02017574|"~     Stroke is one of the leading causes of chronic disability in Veterans. Stroke is associated~     with significant loss of mobility, increased risk of falling, cardiovascular disease,~     depression and neuro-cognitive impairment. These deficits negatively impact the independent~     completion of the Activities of Daily Living (ADLs). Task-oriented training has emerged as~     the dominant therapeutic intervention in the rehabilitation of chronic stroke victims. The~     effectiveness of these interventions may be enhanced through facilitation of implicit~     knowledge rather than explicit knowledge. Specifically, implicit learning increases~     retention and improves transfer of the improved motor function outside of the lab~     environment. Moreover, implicit motor control reduces the burden imposed on cognitive~     resources as the skill is performed automatically (i.e. do not have to 'think' about it).~     The amount and type of feedback individuals receive while learning a new task (or relearning~     in the case of rehabilitation) has been shown to influence the type of learning (i.e.~     implicit or explicit). Thus the purpose of the current study is to determine the effect of~     different types of feedback during motor learning on the learning type and the resultant~     impact on functional outcomes (i.e. motor performance, retention, and cognitive workload) in~     chronic stroke patients.~   "
79445|NCT02017561|"~     Metabolic syndrome (MS) is a cluster of risk factors for cardiovascular disease with~     increasing prevalence worldwide and insulin resistance is central to its pathophysiology and~     multi-organ deleterious effects. One of the most affected organs, the heart, undergoes a~     remodeling process with an increase in fibrous tissue that impairs global cardiac function.~     Considering that myocardial fibrosis increases myocardial stiffness, one important~     determinant of diastolic function, it probably contributes decisively to subclinical left~     ventricular diastolic dysfunction (DD) and heart failure with preserved ejection fraction in~     patients with MS.~      Since insulin resistance is a dominant player in the pathophysiology of MS, improvement of~     the metabolic profile of these patients with metformin might be associated with favorable~     remodeling of myocardial structure and an improvement in myocardial function. Metformin is a~     widely used drug to treat type 2 diabetes mellitus and is considered an option in the~     treatment of high-risk non-diabetic patients with MS, in addition to lifestyle counseling~     including a healthy diet and physical activity.~      In this way, we aim to: i) assess if treating non-diabetic patients with MS and DD with~     metformin in addition to lifestyle counseling decreases cardiac fibrosis and improves~     diastolic function and assess its impact in functional capacity and health-related quality~     of life (HRQoL); ii) evaluate if biomarkers of cardiac remodeling and inflammation are~     predictive factors of response to metformin treatment in these patients.~      This is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial (scheduled~     follow-up of 24 months) with 2 arms: lifestyle counseling only and lifestyle counseling plus~     metformin (maximum dose of 1000mg twice daily).~      The primary endpoint will be change in change in mean of septal and lateral early diastolic~     mitral annular velocities (E') (at the end of the 24 months of follow-up).~      The secondary endpoints will include a composite of major cardiovascular events; diastolic~     function parameters at rest; plasma levels of insulin, glucose, insulin resistance index,~     NTproBNP, high-sensitivity C-reactive protein, tumor necrosis factor-α (TNFα), tissue~     inhibitor of matrix metalloproteinase type 1 (TIMP1) and growth differentiation factor-15~     (GDF-15); functional capacity; epicardial, pericardial and abdominal adipose tissue volumes,~     and coronary calcium score; HRQoL.~   "
79446|NCT02017548|"~     In a multicenter, randomized clinical trial of default options in advance directives among~     patients with incurable diseases, we will determine whether this simple and readily scalable~     intervention can improve patients quality of life and reduce resource utilization without~     reducing the number of days that patients are alive and living outside of an acute-care~     hospital.~   "
79447|NCT02017535|"~     The purpose of the study is:~        1. To find out how long teenagers getting talk therapy (interpersonal psychotherapy) for~          depression should get therapy before the therapist decides whether or not the teenager~          is improving enough, and~        2. To compare two ways of providing treatment to teenagers who have not improved enough.~   "
79448|NCT02017522|"~     In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to~     examine inflammation.~   "
79449|NCT02017509|"~     This is an observational study of tumor samples and MRI imaging in patients with colorectal,~     melanoma, breast, renal cell, lung, bladder, head and neck, ovarian and thyroid cancers. A~     tumor sample, MRI scans, and treatment outcome data will be used for research purposes to~     see if it is possible to predict patients' response to treatment.~   "
79450|NCT02017496|"~     The study explores the safety of breast conserving treatment (BCT)(defined as complete~     removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.~   "
79451|NCT02017483|"~     Lots of studies suggest that children with ADHD have deficits in facial emotion recognition,~     especially for the negative emotion. But there were arguments for this deficit is a~     secondary problem due to the general attention impairment in ADHD, or a specific social~     cognitive processing to ADHD. The objectives of this study are to investigate that~     association between the deficits in facial emotion recognition and the emotional attention~     processing in ADHD. In this study, the investigators use the emotion attentional bias and~     emotional go / no go paradigm to answer this question.~   "
79452|NCT02017470|"~     This research focuses on health needs, constructed meanings of health, and meaningful health~     promotion tactics among women who are heart disease patients. Women with heart disease are~     considered as a highly vulnerable group for cardiovascular disease-related deaths in~     Singapore. Because the culture-centered approach has previously demonstrated that~     community-driven participatory processes of the Culture-Centered Approach (CCA) foster~     positive changes in health outcomes, this project highlights involvement of community~     members in developing effective health promotion regarding heart health. Rather than relying~     solely on interventions created by outside experts, The investigators aim to engage in Heart~     Health promotion that is meaningful through the involvement of these community members in~     processes of change.~      Thus, the investigators seek to engage these women who are heart disease patients in~     developing a heart health intervention that is beneficial to them. Through in-depth~     interviews, focus groups, the formation of advisory boards, and community-wide dialogue~     workshops led by these women, the investigators seek to identify specific heart health~     promoting strategies and tactics that are meaningful to the lived experiences of the women.~     As part of the overall solution, this project will work alongside the Women's Heart Health~     Clinic to create training materials and disseminate findings based on our analysis.~      Methodology:~      As far as the methodology, the investigators are using the Culture-Centered Approach (CCA)~     as well as using biomedical measures for evaluation. First, an advisory board will be formed~     to inform each step of our methodology and data analysis. First, the investigators will~     randomize one group of patients into the control group and one group into the experimental~     group. The investigators will conduct baseline measures for both groups. For the control~     group, the investigators will measure biomedical data at 3 times (3 months, 6 months, and 12~     months). For the experimental group, the investigators will create advisory board that will~     consist of approx. 4 physicians and 6 patients. In-depth interviews will be conducted with~     women who have experienced CVD and who live in Singapore. Each interview will last a maximum~     of 90 minutes. Interviewees will be asked questions about how they understand health, their~     health experiences, and the obstacles they face in accessing health care in Singapore. Data~     from the interviews will be analyzed with the advisory board and will be used to guide~     discussion for the focus groups of women in the experimental group.~      Focus group sessions, each lasting a maximum of 90 minutes, will be conducted with the~     patients in the experimental group. In each session, the participants will collectively~     develop potential solutions for the issues that emerged during the earlier interviews.During~     the one-year period of study, a participant in the experimental group can participate in one~     or many of the one-on-one interviews, focus groups, or other activities planned based on the~     feedback of the participants. Based on the information given in the interviews, advisory~     board meetings, and focus groups, an intervention will be designed and carried out for the~     experimental group. This group will also be evaluated at 3 time points (3 months, 6 months,~     and 12 months) in addition to baseline.~   "
79453|NCT02017457|"~     The present project is a multicenter, phase II trial which aims at evaluating if the~     administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could~     improve the response rate to DLI in the population of patients with relapsed acute myeloid~     leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell~     transplantation.~   "
79454|NCT02017444|"~     Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1~     inhibitor (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial~     hypertension (IIH) IIH is a condition of young, overweight women with characteristic raised~     intracranial pressure (pressure around the brain) leading to papilloedema (swelling of the~     nerve supplying the eye), visual loss and headaches. Medical literature (Cochrane review)~     demonstrates there is little evidence for the treatments used for IIH. Weight control~     appears the most effective method of improving symptoms but weight loss is difficult to~     maintain. 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates~     local steroid levels and our previous research suggests it may influence the production of~     brain fluid(cerebrospinal fluid or CSF). 11β-HSD1 levels fall with weight loss and this is~     associated with with decreased intracranial pressure.~      Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce~     the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter~     the study if they are between 18-55 years old with acute (<6 months) IIH, signs of active~     disease (papilloedema and raised CSF pressure (>25 cmH20)), no other major illnesses and~     have no plans for pregnancy during the study period.~      This is an MRC funded single centre, phase II, double-blinded, randomised control drug~     trial. It will be conducted at the University Hospital Birmingham and the University of~     Birmingham will act as Sponsor. Eligible participants will be randomly assigned to AZD4017~     or a placebo ('dummy' with no active drug) for 3 months with a follow up a month later.~     Investigations during the study will include bloods, urine samples, pregnancy tests, lumbar~     punctures, DXA scans and small fat/skin biopsies. Participants will benefit from increased~     monitoring and a potential improvement in their condition.~      We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and~     consequently treat patients with IIH, thus opening a new and entirely novel therapeutic~     avenue.~   "
79455|NCT02017431|"~     The study probes the effects of combined exposures to diesel exhaust and allergens on lung~     function and on the immune system, specifically focusing on the ability of a particle~     depletion technique to attenuate effects we and others have seen previously. Individuals are~     exposed to either filtered air (FA), carefully controlled levels of diesel exhaust (DE) or~     particle-depleted diesel exhaust (PDDE) in our exposure chamber, after which the~     investigators will administer an inhaled allergen challenge. 48h later, a procedure called~     bronchoscopy is used to collect samples from the lungs. After 1 month, the entire procedure~     is to be repeated with one of the alternate exposures. This will be repeated 4 times (4~     exposures; 2 filtered air, 1 diesel exhaust, 1 particle-depleted diesel exhaust)~   "
79456|NCT02017418|"~     This study was designed to test whether two zeaxanthin formulations (supplements containing~     different nutritional compounds with zeaxanthin and omega fatty acids being the primary~     ingredients of interest) influenced visual motor function. Visual motor function refers to~     the processing speed of the visual system and how individuals respond behavioral to visual~     stimuli (e.g., reaction time).~   "
79457|NCT02017405|"~     The purpose of this study is to determine the digestibility of serum-derived bovine~     immunoglobulin protein isolate in healthy adults. The information generated may help~     elucidate SBI's mechanism of action.~   "
79458|NCT02017392|"~     The purpose of this study is to determine whether the compound lidocaine cream is effective~     in preventing postoperative agitation in patients with endotracheal intubation for general~     anesthesia.~   "
79459|NCT02017379|"~     This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs~     (Drugs which are known to speed up the emptying of the stomach or in other words to move the~     blood out of the stomach faster) given before endoscopy to patients with upper~     Gastrointestinal bleeding compared to patients who will not receive either of these~     medications before their endoscopy.~   "
79460|NCT02017366|"~     It is well known that there is a considerable postoperative weight loss in patients~     undergoing esophageal resection for cancer.~      We believe that this weigh loss can be limited by administering postoperative enteral~     feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks~     postoperatively.~      We hypothesize that patients undergoing esophageal resection for cancer will have a better~     overall survival with postoperative additional enteral feeding than when on regular oral~     diet alone.~   "
79461|NCT02017353|"~     This therapy aims to determine whether curcumin can inhibit tumor induced inflammation in~     patients with endometrial carcinoma. In addition, curcumin could possibly induce a better~     functioning of chemotherapy and a decrease in toxicity from chemotherapy. Various studies~     have demonstrated that curcumin can have an effect on tumor growth and the development of~     metastases.~   "
79462|NCT02017340|"~     Alzheimer's disease (AD) is an ever-increasing public health concern among the aging~     population and is the most common form of dementia affecting more than 15 million~     individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD~     and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).~      Even modest therapeutic advances that delay disease onset and progression could~     significantly reduce the global burden of the disease and the level of care required by~     patients. While there are symptomatic-based drug therapies available for AD, these~     medications do not prevent the disease process itself. There is therefore an imperative to~     develop new treatments for AD that have disease modifying effects. This double-blind placebo~     controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild~     to moderate AD over a treatment period of 18 months. There is a strong scientific rationale~     for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and~     restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in~     AD patients and clinical studies with this medication have shown stabilization of cognitive~     decline and reduced incidence of AD, pointing to both symptomatic and disease modifying~     benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a~     range of medical morbidities and frailty will be included in the study. If this trial is~     successful, nilvadipine would represent an advance in the treatment of AD patients and would~     have a major impact on the health and social care costs incurred in Europe by this~     neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support~     future clinical trials and research innovation in AD across Europe.~   "
79463|NCT02017327|"~     Primary objective:~      The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01%~     and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of~     conjunctival hyperaemia in the worse eye at Day 84.~      The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).~   "
79528|NCT02016482|"~     This study is being conducted to assess the safety and efficacy of adalimumab in subjects~     with nail psoriasis.~   "
79653|NCT02014844|"~     This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with~     glioblastoma who have progressed following surgery and prior treatments.~   "
79466|NCT02017288|"~     Background:~      - Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer~     develops over several years, beginning as white or red patches in the mouth or throat that~     become growths. It can also cause a condition that leads to rigidity of the cheeks. The~     growths can be identified when a doctor looks into a person s mouth. It is currently not~     clear why some people with abnormal growths progress to cancer while others do not.~     Researchers want to better understand why some patients with early abnormal growths get late~     abnormal growths. They also want to understand why some people get abnormal growths again,~     even after they receive treatment.~      Objectives:~      - To understand why some people with precancerous lesions in their mouth develop cancer~     while others do not.~      Eligibility:~      - Adults 21 years and older, some with abnormal growths in the mouth, some without any, and~     some with head and neck cancer.~      Design:~        -  Participants will visit a hospital in Taiwan 2 times.~        -  At the first visit, participants will answer questions about their health, lifestyle,~          and family medical history. A doctor will examine the participant s mouth and take a~          small piece of any growth they see. They will do this with a brush. They will also~          photograph the participant s mouth. Participants will also give blood and saliva~          samples, plus a small sample of a mouth rinse.~        -  Participants who are diagnosed with a late abnormal growth that is not cancer will~          return for a second visit. They will answer the same questions and undergo the same~          procedures as at the first study.~   "
79467|NCT02017275|"~     PANDA III is sought to investigate the safety and efficacy of a PLGA-polymer with~     electro-grafting base layer sirolimus-eluting stent (SES) versus a PLA-polymer SES at 12~     months follow-up.~   "
79468|NCT02017262|"~     This project addresses the important public health need to reduce ethnic disparities in~     depression care by pilot testing and refining a culturally tailored, low-cost intervention~     for improving both depression and general medical outcomes among Latinos in safety net~     primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group~     self-management intervention that educates and empowers patients in their own health care~     and has the potential for widespread implementation and sustainability in primary care~     because it is responsive to patient, provider, and system preferences and needs. After~     completing an assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano,~     Mente Sana with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot~     findings, we will revise the intervention and study plan, and will conduct a second pilot~     trial. After reviewing findings from this second trial, we will finalize the intervention~     and study plan in preparation for larger studies to test Cuerpo Sano, Mente Sana versus~     other interventions for addressing depression among Latinos in safety net primary care.~   "
79469|NCT02017249|"~     The purpose of this study is to learn more about the ability of a substance called arginine~     to improve the functioning of the immune system in people with a certain type of brain~     tumor. This could lead to improvements in a type of treatment for brain tumors called~     immunotherapy. The immune system includes organs, cells, and substances in the body that~     fight infection and disease. Immunotherapy is a type of treatment that uses the immune~     system as a tool to seek out and destroy abnormal cells. Immunotherapy requires that the~     immune system be working properly. Arginine is a normal component of protein (an amino acid)~     that we all consume in foods such as red meat, poultry, fish, and dairy products and that~     our bodies can make. Arginine helps the immune system function normally. Recent research has~     shown that certain types of brain tumors decrease the amount of arginine in the body leading~     to impaired immune system function. This may interfere with the ability of immunotherapy to~     fight abnormal cells. We would like to see if giving people with brain tumors arginine in~     powder form will make their immune systems work better.~   "
79470|NCT02017236|"~     The purpose of this study is to evaluate to determine the effect of food on the PK of a~     single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.~   "
79471|NCT02017223|"~     This project proposes to use mobile devices to develop new tools for pediatric obesity~     prevention and treatment targeting underserved minority adolescent populations at high risk~     for obesity and related diseases. We will use off the shelf, validated and wearable wireless~     sensors to measure physical activity, blood pressure, sleep, heart rate, galvanic skin~     response and blood glucose levels and communicate the measured information to a mobile phone~     using a wireless interface. This will deliver a record of behavior and health data that is~     time-stamped, synchronized, and geographically localized using GPS to a secure server. Data~     will then be analyzed and displayed to participating health professionals to provide them~     with readily interpretable records of continuously monitored energy expenditure, recorded~     and synchronized with other essential biological, behavioral and geographical data. To~     accomplish this project, 50 African American and Hispanic youth (50% female, ages 12-17)~     will be recruited into the research in advisory capacities, to test the sensors during~     development, and to wear the sensors for three non-contiguous weeks. To test the sensors~     prior to use with minority youth, 30 college students age 18 and above will be recruited to~     try out the sensors in and outside of the laboratory in order to make sure that all sensors~     are in perfect working order before testing them in minority youth populations. An advisory~     group of medical professionals will be assembled to guide us through the process of~     developing a web interface that will ensure that the right information will be displayed in~     an easily interpretable fashion. The advisory group will participate in regular meetings to~     develop and test the web interface. Using the data acquired, health professionals will be~     able to visualize average amounts of physical activity, sleep, sedentary behaviors (daily or~     weekly) as well as daily patterns. Average blood glucose, heart rate, and stress levels~     (daily or weekly) as well as daily patterns will also be available. Practitioners will be~     able to see when and where activity and metabolic events are occurring, enabling preemptive~     and preventive strategies as well as targeted interventions to prevent and treat pediatric~     obesity in underserved and at-risk minority youth.~   "
79472|NCT02017210|"~     STUDY PART 1 People who are overweight and/or obese usually are insulin resistant and so are~     at risk of type 2 diabetes. However, research has shown that some overweight and/or obese~     people remain insulin sensitive and healthy despite their weight.~      The investigators hypothesise that insulin-sensitive overweight and/or obese people maintain~     their insulin sensitivity and metabolic health over time. The investigators also hypothesise~     that the preservation of insulin sensitivity will be determined by key metabolic factors.~      STUDY PART 2 The cause of insulin resistance is potentially related to special fats~     (sphingolipids) within the skeletal muscle. Insulin resistance usually improves after weight~     loss but it is not yet known how these sphingolipids behave.~      The investigators hypothesise that improvement in insulin sensitivity with calorie~     restriction and weight loss will be coupled with decreases in specific skeletal muscle~     sphingolipids.~   "
79473|NCT02017197|"~     The purpose of this study is to assess whether the switch from branded to generic warfarin~     or between different generic warfarin tablets may cause fluctuation in the results of~     coagulation tests (International Normalized Rate, acronym INR) in patients, thus~     predisposing them to unnecessary risks.~   "
79654|NCT02014831|"~     The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic~     penile carcinoma~   "
79475|NCT02017171|"~     Despite improvements during the past 20 years in blood glucose and blood pressure control,~     diabetic kidney disease remains one of the most important causes of health problems in~     patients with diabetes. Novel treatments to complement blood glucose and blood pressure~     control are urgently needed. The goal of this study is to see whether a medication called~     allopurinol may help prevent loss of kidney function among people with type 1 diabetes.~     Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a~     disease characterized by arthritis, especially of the foot joints. There is evidence~     suggesting that allopurinol might also be useful in people with diabetes who have normal or~     moderately impaired kidney function to decrease the risk of developing advanced kidney~     disease in the future. To prove this beneficial effect of allopurinol, we will be conducting~     an international clinical trial at eight diabetes centers, enrolling approximately 480~     patients with type 1 diabetes who are at increased risk of developing kidney disease.~     Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for~     three years, during which they will be followed through periodical visits. To prevent any~     possible bias, neither the participants nor the clinical staff knows who is taking~     allopurinol and who is taking the placebo. Kidney function will be measured at the beginning~     and at the end of the treatment period to see whether patients taking allopurinol experience~     a slower loss of kidney function over time as compared to those taking the inactive pill. If~     this trial is successful, the reduction in health problems resulting from the prevention or~     delay of kidney function loss due to the use of allopurinol would have a major impact on the~     lives of type 1 diabetic patients as well as on society at large, significantly reducing the~     human and financial costs associated with diabetic kidney disease. Because of the emphasis~     on early intervention, the proposed trial, if successful, will establish a new paradigm in~     treatments to slow or prevent progression towards end stage kidney disease in type 1~     diabetes far beyond anything achieved to date.~   "
79476|NCT02017158|"~     The purpose of this study is to develop, disseminate, and evaluate a web-based nutrition and~     gardening game using interactive, multiplatform and mobile gaming, rich narrative, a~     pedagogical agent, meaningful play, and experiential learning to prevent/treat obesity in~     minority 3-5th grade youth and their families.~   "
79477|NCT02017145|"~     The purpose of the current work is to determine the efficacy of the re-application of~     surgical prep solution in decreasing surgical site bacterial contamination following lower~     extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding~     the surgical site during the initial healing phases would theoretically decrease the rate of~     infection in high-risk persons.~   "
79478|NCT02017132|"~     Pomegranate has gained widespread popularity since the health effects of the whole fruit, as~     well as its juices and extracts, have been studied in relation to a variety of chronic~     conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.~      The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and~     compounds such as polyphenols, but is not an edible part of the plant. In order to harness~     the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then~     easily consumed as pomegranate extract capsules.~      Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors,~     particularly with respect to decreasing blood pressure and increasing insulin sensitivity.~     Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat~     reduction have been shown using pomegranate and its extracts. In animal models it has been~     shown for both extract and leaf that there were significant decrease in food consumption and~     body weight, inhibiting the development of obesity. In the few human studies, there appeared~     to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body~     weight increase, for both juice and seed oil.~      This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous~     results concerning the effect of whole pomegranate fruit on biochemical and physiological~     markers using a new pomegranate extract and to conduct original work to explore its effect~     on body weight, measurements and fat mass. Any similar interventions have not been double~     blinded or used pomegranate in extract form. Changes in physiological and biochemical~     markers will also be investigated.~      The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass,~     body measurements and blood pressure.~   "
79479|NCT02017119|"~     Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a~     first line treatment for HE, but the adherence to this treatment is relatively low, due to~     side effects such as diarrhea, distention, etc.~   "
79480|NCT02017106|"~     Varicose veins of the leg often have superficial tributaries, which are often symptomatic~     and a major reason for coming to the doctor. When treating the main varicose vein inside the~     leg, some doctors prefer to remove these tributaries while others prefer to leave them. This~     trial aims to see if it is better to remove these veins at the time of the first laser~     procedure or better to leave them and only remove them when asked.~   "
79481|NCT02017093|"~     The purpose of this pilot study was to explore the impact of enhancement of the velocity~     component error in the course of reaching movements of the impaired/hemiparetic limb in an~     acute stroke subject. We hypothesized that the method would shift velocity profiles toward~     the optimal, resulting in a reduction in error. A prototype robot. This robotic device~     system has a two-dimensional motor, basic measurement capacities, and a robotic arm which is~     engaged to the subject's upper-limb in a sitting position.~      The enhancement of the velocity component error would shift velocity profiles toward the~     optimal, resulting in a reduction in error.~   "
79482|NCT02017080|"~     Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the~     fetal thyroid gland could be an important tool for detecting fetal thyroid dysfunction in~     mothers with autoimmune thyroid disease.~   "
79483|NCT02017067|"~     Previous studies have demonstrated that resistance training (RT) is beneficial to increase~     muscle strength, improve functional ability and the ability to rapidly produce force, known~     as the contractile rate of force development (RFD) in older adults. However, much less~     research has focused on the effect of RT on the lower extremity muscle strength, contractile~     RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially~     for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose~     of this study was to investigate the effect of RT on the lower extremity muscle strength,~     RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially~     for OP and knee OA (KOA). The investigators hypothesized that such a training program would~     lead to induce not only specific muscle strength enhancement but also an increment in~     contractile RFD and impulse.~   "
79484|NCT02017054|"~     The purpose of this study is to assess the feasibility of performing repetitive coronary~     angiograms via the radial approach~   "
79485|NCT02017041|"~     The purpose of this study is to evaluate the usability of an interactive smartphone~     application (app) designed to engage and support patients receiving bup/nal.~   "
79486|NCT02017028|"~     The aim of this study is to investigate the relation between the previous presence of~     endothelial dysfunction and the development of radial artery vasospasm during the~     trans-radial coronary evaluation.~   "
79487|NCT02017015|"~     The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined~     with gemcitabine in Chinese patients with metastatic pancreatic cancer.~   "
79715|NCT02014038|"~     Health status information and physical activity level will be collected longitudinally on a~     large group of individuals who are ultramarathon runners at the time of enrollment to~     determine if very high levels of physical activity alter health risks compared with~     sedentary or moderately active lifestyles.~   "
79488|NCT02017002|"~     Esophagectomy for esophageal cancer is a technically complex procedure which is associated~     with high perioperative mortality, even in high volume centers[1]. To facilitate the~     postoperative recovery of esophagectomies patients by reducing surgical trauma, an~     increasing number of surgeons have attempted minimally invasive esophagectomy (MIE) to treat~     patients with esophageal cancer.[2-10] However, there is no consensus regarding the optimal~     method for performing an esophagectomy with the minimally invasive surgical technique. In~     addition, the benefit of this approach has not been well confirmed based on the limited~     retrospective comparative studies at the present time [3, 11-12], although its potential~     benefit improving the immediate postoperative including the total morbidity and pulmonary~     complication has been demonstrated by meta-analyses[13]. Especially it is unclear whether~     adding laparoscopic procedures in MIE can contribute to further improvement of the~     perioperative outcome of the patients.[3] Previously, the investigators have found that~     adding of laparoscopic procedure in performing the esophageal reconstruction procedure after~     VATS esophagectomy can provide further benefit in reducing the postoperative major~     complications and fasten the postoperative recovery16. For the most cases, the patients was~     receiving tri-incision esophagectomy, i.e. VATS esophagectomy in the chest, laparoscopic~     gastric mobilization in the abdomen and left cervical esophagogastrostomy. In such~     circumstances, a cervical incision was required for esophagogastrostomy after esophagectomy~     and gastric mobilization. However, for the patients with lower-to mid third esophageal~     cancer, some surgeon performed Ivor Lewis esophagectomy, which performing the~     esophagogastrostomy in the chest after gastric mobilization without cervical incision wound.~     Although both of these procedures have been demonstrated to be feasible and safe, there is~     much debate about the advantage and disadvantage of these two approaches. For tri-incision~     esophagectomy, patients have the chance to have cervical lymph node dissection and the~     esophagus can be resected up to the neck. However, it is more time-consuming and associated~     with more surgical trauma by adding a cervical incisional wound and more tissue dissection~     around the cervical trachea as compared to that done by Ivor Lewis esophagectomy. In~     contrast, for the Ivor Lewis esophagectomy, the resection of esophagus was limited to the~     level of thoracic inlet and cervical lymph node dissection was impossible unless a neck~     incision was further created. However, it takes less time in performing the whole procedure~     by saving a neck incision.~   "
79489|NCT02016989|"~     The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It~     is a double blinded comparison of epithelial defect in two groups of patients randomized~     between CACICOL20 and physiological salt solution.~   "
79490|NCT02016976|"~     The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine~     2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when~     implanting a permanent pacemaker.~   "
79491|NCT02016963|"~     This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in~     healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months~     ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable~     female subjects) will receive a second dose of raxibacumab equal to that of the previous~     dose >= 4 months following the first dose. Subjects will remain in house from Day 0 until~     Day 1 and will be followed for 70 days after receiving the second dose of raxibacumab.~     Raxibacumab has been shown to provide improved survival in rabbit and monkey anthrax spore~     challenge studies. Preliminary data from our rabbit pivotal efficacy study showed~     significant survival benefit for raxibacumab over placebo. Exposure to anthrax and resulting~     clinical disease can occur more than once, especially in individuals who do not develop~     protective immunity. Hence, if clinically indicated for the treatment of anthrax, there may~     be a requirement for the repeat administration of raxibacumab. The rationale of the study is~     to evaluate the immunogenicity and safety of repeat administration of raxibacumab with a >=~     4 month interval between dosing.~   "
79492|NCT02016950|"~     Investigators seek to observe the long term patterns of arrhythmias detected by permanent~     pacemakers.~   "
79493|NCT02016937|"~     In our study we aimed to compare the lactation process by mothers who were undergoing~     elective Caesarian section under general anesthesia, spinal anesthesia, epidural anesthesia~     and normal vaginal birth.~   "
79494|NCT02016924|"~     The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK)~     and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted~     darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically~     suppressed, pediatric participants between the ages of 3 months to < 18 years of age.~      This study will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co~     each co-administered with a background regimen (BR) through 48 weeks and during the 5 year~     long-term treatment.~      There will be 2 parts to the study.~        -  Part A: Participants will be enrolled sequentially by age cohort to evaluate the steady~          state PK and confirm dose of ATV/co and DRV/co. Following screening, enrolled~          participants will continue their suppressive regimen of either ATV/r or DRV/r~          once-daily plus their BR. On Day 1, participants will discontinue ritonavir and~          initiate once daily cobicistat (COBI) to be taken with their ATV or DRV plus their BR.~          All participants enrolled in Part A will participate in an intensive PK evaluation of~          COBI and ATV or DRV on Day 10. Following completion of the intensive PK visit,~          participants will continue to receive COBI coadministered with DRV or ATV each with a~          BR and return for scheduled study visits.~        -  Part B: Participants will be enrolled to evaluate the safety, tolerability, and~          efficacy of the ATV/co or DRV/co regimen. For all cohorts in Part B, participants will~          be screened and initiated sequentially by each age cohort following confirmation of~          appropriate COBI exposure and PI exposures from the corresponding age cohort in Part A.~   "
79495|NCT02016911|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of~     oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of~     hepatic impairment compared to subjects with normal hepatic function.~   "
79496|NCT02016898|"~     The primary focus of this study is to assess intraocular pressure and complication rates~     between patients who receive mitomycin-C using a sponge versus no-sponge.~   "
79497|NCT02016885|"~     The purpose of this study is to evaluate the safety and efficacy of DRM04B compared to~     vehicle for the treatment of axillary hyperhidrosis.~   "
79498|NCT02016872|"~     The purpose of this study is to help researchers investigate if a new imaging agent named~     18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well~     as whether disease will reoccur in the future. The study will also investigate whether a~     18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will~     respond to standard therapy. Information obtained from this study may help doctors design~     future studies in which they may target tumor areas that do not respond to therapy or may~     likely reoccur in the future.~   "
79499|NCT02016859|"~     Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed~     that this value may be another prognostic factor in critically ill patients such as those~     admitted to ICU, or those with neutropenic Fever.~      The purpose of the study is to check if the IPF may be used as a prognostic Factor in these~     patients~   "
87144|NCT01916759|"~     To use a systems biological approach to study the molecular signatures of innate and~     adaptive responses to vaccination in a HIV infected versus uninfected adult population in~     Kampala, Uganda.~   "
79501|NCT02016833|"~     This study is a clinical study aiming at establishing immunological assays for the~     qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune~     responses in cancer patients. Such a study will allow the development of suitable~     immunological tools to be used in assessing response in a subsequent phase I study aiming at~     evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16~     E7-expressing tumors. In addition, this study will help defining the baseline~     cancer-associated immune responses in the selected patient population.~      Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this~     study.~      WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex~     vivo and cultured IFNg ELISpot as well as tetramer staining.~   "
79502|NCT02016820|"~     The colonic microbiome is essential in health and disease, and is highly dynamic during the~     first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor~     antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the~     pediatric colonic microbiome are unknown. This study will determine whether acid suppression~     with these medications affects the microbiome of otherwise healthy children who are~     prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the~     duration and magnitude of microbiome changes.~   "
79503|NCT02016807|"~     RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an~     effective single therapy approach for the management of chemoradiation mucositis, treating~     and preventing its occurrence in the oral cavity, esophagus, stomach, small and large~     intestine.~      PURPOSE: This observational multi-phase trial is studying how well polymerized~     (cross-linked) sucralfate malate paste (ProThelial) works to prevent and treat mucositis in~     adult patients who are to receive or have received chemo/radiation therapy that have caused~     or is anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large~     intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The~     Phase I study addresses prevention and treatment in the esophagus, stomach, small and large~     intestine.~   "
79504|NCT02016794|"~     Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment~     may require anterior decompression and fusion, which usually is established with a cage~     implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.~   "
79505|NCT02016781|"~     This study is designed as a multicenter trial, with biological assignment to one of two~     study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell~     transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.~   "
79506|NCT02016768|"~     There is a relationship between CSM and hypertension, probably a cause/effect relationship,~     and investigators term this type of hypertension cervicogenic hypertension. Abnormally~     functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately~     activate and inhibit parts of the central and autonomic nervous systems as part of a chronic~     stress response, which causes hypertension and migraine. This theory is now being expanded~     to encompass both CSM and essential hypertension, the idea being that these two conditions~     are intimately related.~   "
79507|NCT02016755|"~     The purpose of the study is to confirm the feasibility of study procedures and the~     tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)~   "
79508|NCT02016742|"~     The purpose of this study is to characterise the pharmacokinetics, safety and tolerability~     of RDC5 given as a single dose to healthy volunteers at a number of different dose levels~   "
79509|NCT02016729|"~     Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute~     myeloid leukemia.~   "
79510|NCT02016716|"~     Purpose of this study is to evaluate the 2 formulations of Romosozumab (AMG785) in~     Postmenopausal Women With Osteoporosis.~   "
79511|NCT02016703|"~     Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a~     clear beverage, compared with placebo (saccharose) in 4-6 year old children.~   "
79512|NCT02016690|"~     This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014~     and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and~     effectiveness of palivizumab for the prevention of serious lower respiratory tract infection~     caused by RSV in participants 24 months of age and under, who have an immunocompromised~     medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other~     types of immunodeficiency; HIV infection; recovering from organ or bone marrow~     transplantation; on chemotherapy; on high-dose corticosteroid therapy; on~     immunosuppressants) or who have Down syndrome.~   "
79513|NCT02016677|"~     The purpose of the study is to collect data regarding the aesthetic outcomes of patients who~     had breast reduction surgery and /or mastopexy in terms such as scaring, patient~     satisfaction, breast ptosis assessment including taking photographs and filling~     questionnaires.~   "
79514|NCT02016664|"~     Oral ketamine is increasingly used by doctors to both reduce the amount of narcotic pain~     medication consumed and to improve chronic pain management in difficult cases. How much is~     absorbed when taken orally, as opposed to intravenously ,is unknown. Ketamine may cause~     sedation, and occasionally cognitive impairment. Therefore, there are safety concerns~     associated with its usage as an out-patient may engage in activities where cognitive~     impairment is dangerous,such as driving. This study is designed to measure the plasma~     concentrations of ketamine and its active metabolite, norketamine, in people taking low dose~     oral ketamine for chronic pain. The goal of the study is to verify that low dose oral~     ketamine produces plasma concentrations below the level associated with toxic symptoms,and~     thus can be safely used long-term for the treatment of chronic pain .~   "
79515|NCT02016651|"~     Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving~     mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific~     marker for aspiration. The objective of this study is to examine if TA pepsin will change~     when ventilated premature infants are positioned in two different positions; on their back~     vs. on their right side.~   "
79529|NCT02016469|"~     The purpose of this study is to evaluate the effect and safety of pectin and fecal~     microbiota transplantation on patients with inflammatory bowel disease. The investigators~     hypothesize that patients who take pectin can promote the migration of probiotics in~     intestine engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the~     inflammation, and to maintain intestinal flora diversity and steady state in a long time.~   "
79516|NCT02016638|"~     Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in~     causation of pregnancy related disorders is yet to be determined. OSA can complicate~     pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and~     hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of~     hypertensive disorders of pregnancy and is associated with adverse maternal and foetal~     outcomes.~      The study would involve pregnant females which would be prospectively followed in pregnancy~     and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep~     disorders would be confirmed by overnight polysomnography and ambulatory blood pressure~     monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation~     with sleep disorders in pregnancy would be analysed.~   "
79517|NCT02016625|"~     The primary objective of this trial is to investigate the effect of multiple-dose~     faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus~   "
79518|NCT02016612|"~     Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help~     shape and hold the breast up on the chest preventing re-stretching and bottoming out of the~     breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be~     measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D~     Imaging system reporting the amount of breast tissue above and below the nipple level.~   "
79519|NCT02016599|"~     Prematurity is a very important problem in this country. Prematurity can cause problems with~     organ (such as the brain, heart, kidneys) growth and development. A very important part of~     keeping premature babies healthy is ensuring good blood flow to all of these organs.~      Some premature babies have problems with their hearts and getting enough blood out to the~     rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is~     found by looking at blood test values and while examining the baby. These babies will need~     medications to help their heart deliver blood to all of the important areas in their bodies.~      Babies who have hypotension requiring medications tend to have more problems than premature~     babies that don't need hypotension medication. Some of these problems include a higher risk~     of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems~     causing difficulty tolerating feeds, and a very dangerous infection of their intestines.~     Some long term effects include hearing loss, developmental delay, and learning problems in~     the future that are worse than other premature babies who did not have hypotension.~     Hypotensive premature babies also have a higher risk of death.~      The cause of hypotension in the first week of life is still not known. We know that babies~     have to get used to being in the outside world instead of in the womb. A lot of changes with~     the heart and lungs have to happen for them to not be affected by that transition. If we~     could gain a better understanding of those changes, we might be able to prevent some of~     these issues from happening.~      This study will look closely at premature babies with and without hypotension to assess the~     heart and lung changes in the first week of life. To do this, we will use monitoring~     machines and tests to get a better idea of all the changes that happen. This information~     will help all neonatologists who care for premature babies.~   "
79520|NCT02016586|"~     To evaluate the benefits of a lactation support intervention, in conjunction with maternal~     nutritional supplementation.~   "
79521|NCT02016573|"~     This is a study investigating the safety and usefulness of the Renal Denervation Procedure~     in reducing high blood pressure in people whose blood pressure is not adequately controlled~     despite already being treated with 2 blood pressure lowering drugs. This study is designed~     to compare the effects renal denervation to a usual care group.~   "
79522|NCT02016560|"~     This is a cross-sectional and longitudinal study that will evaluate imaging characteristics~     of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and~     Alzheimer's disease (AD) subjects.~   "
79523|NCT02016547|"~     Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30~     of symptoms onset. Efficacy of this therapy is limited in the setting of large artery~     occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions~     (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis~     is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which~     limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may~     reach 90% with last generation devices. A recent meta-analysis has shown that the best~     candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular~     therapy efficacy is increased in association with antiplatelets such as abciximab. The aim~     of the study was to assess the feasibility of thrombectomy associated with abciximab on~     revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in~     order to design a clinical trial versus the gold standard for acute ischemic stroke~     revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating~     feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic~     stroke patients within 4h30 of symptoms onset.~   "
79524|NCT02016534|"~     This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG~     337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal~     adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the~     objective response rate of AMG 337 by tumor type.~   "
79525|NCT02016521|"~     In humans, the primary means of cooling the body during exercise is through the evaporation~     of sweat from the skin surface. Clothing represents a layer of insulation that hinders the~     evaporation of sweat from the surface of the skin. It follows that clothing that imposes the~     least amount of resistance to evaporative heat loss may prove beneficial to the~     thermoregulatory, physiological and perceptual response to exercise, particularly in elite~     endurance-trained athletes. Thus, the purpose on this study is to examine the influence of~     wearing a sportswear garment made of a fabric (100% nylon) with superior evaporative~     characteristics on detailed thermoregulatory, cardiorespiratory, metabolic and perceptual~     responses to maximal exercise testing at normal room temperature and relatively humidity in~     a group of 25 endurance-trained cyclists and triathletes aged 20-60 years. It is~     hypothesized that wearing a garment made of 100% nylon will improve exercise performance~     (e.g., exercise endurance time) and that this improvement will reflect improvements in~     thermoregulatory, cardiorespiratory, metabolic and perceptual responses to exercise.~     Athletes will be recruited via contact with coaches of the McGill University Cycling and~     Triathlon teams as well as through contact with coaches of competitive cycling and triathlon~     teams/training groups in the Montreal and surrounding area. Initial contact will consist of~     a thorough explanation of the study procedures and pre-screening for the inclusion/exclusion~     criteria prior to study consent by the Principal Investigator and/or his delegate, either in~     person or by telephone or email. Eligible participants will visit McGill's Clinical Exercise~     & Respiratory Physiology Laboratory on 3 separate occasions over a period of 10-14 days.~     Visit 1 will include a maximal incremental bicycle exercise test for familiarization~     purposes and to determine maximal power output (MPO). Visits 2 and 3 will include a~     constant-power-output bicycle exercise test at 85% MPO under one of two conditions, in~     randomized order: (1) while wearing a garment made of 100% polyester, i.e., placebo; and (2)~     while wearing a garment made of 100% nylon, i.e., cooling fabric. At rest and during~     exercise at visits 2 and 3, detailed assessments of core body temperature will be made using~     a temperature sensor placed into the esophagus, while skin temperature and other~     physiological and perceptual parameters will be measured using standard techniques.~   "
79526|NCT02016508|"~     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy~     of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects~     with geographic atrophy secondary to age-related macular degeneration.~   "
79527|NCT02016495|"~     To evaluate whether a combined supplementation of magnesium and lipoic acid is able to~     significantly reduce the incidence of uterine contractions and related episodes of~     hospitalization in pregnant women.~   "
79531|NCT02016443|"~     Herniorrhaphy is the most frequent general surgical procedure. There are moderate pain~     complaints after herniorrhaphy. Besides causing discomfort to the patients, pain, can delay~     recovery and discharge and cause cognitive dysfunction and difficulty with returning to~     normal daily activity.~      A combination of analgesics with different effect sites can reduce the doses needed and~     analgesic related side effects which is called multimodal analgesia .~      Opioids, acetaminophen, nonsteroid anti-inflammatory drugs and cox-2 inhibitors, alfa-2~     receptor agonists, steroids, gabapentin and pregabalin have been used for this purpose(4).~      Tizanidine is an alfa-2 receptor agonist, and is used for musculoskeletal pain conditions.~     Tizanidine reduced the local anesthetic requirement in spinal anesthesia.~      The aim of this study is to investigate the hypothesis that: Tizanidine can reduce the pain~     scores, analgesic consumption, analgesic related side effects and provide early return to~     normal daily activity compared to placebo after inguinal herniorrhaphy.~   "
79532|NCT02016430|"~     Our group has recently identified the association between gut-flora-mediated carnitine and~     phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and~     cardiovascular risk. This study investigates the ability for dietary intervention to~     modulate TMAO levels.~   "
79533|NCT02016417|"~     The present study is a randomized, control, phase II study of locally advanced~     nasopharyngeal carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or~     Docetaxel，cisplatin regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by~     concurrent chemoradiotherapy.~   "
79534|NCT02016404|"~     The purpose of this study was to investigate the effects of low-sodium, high-potassium~     condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.~   "
79535|NCT02016391|"~     The purpose of he study is to evaluate effects of dexmedetomidine on pain during~     radiofrequency ablation of liver and kidney tumours.~   "
79536|NCT02016378|"~     This study investigates the effect of a computerized approach/avoidance retraining (aka~     cognitive bias modification) over and above treatment as usual for adolescents in treatment~     for substance use disorders. The computerized training entails viewing pictures of drug and~     non-drug related stimuli, and then using the computer to make the drug pictures smaller and~     the non-drug pictures larger. Participants will also take part in an EEG/event-related brain~     potential assessment at the beginning and end of treatment to identify brain measures that~     are associated with treatment response.~   "
79537|NCT02016365|"~     The primary objective for this study is to evaluate the efficacy of doxycycline +~     ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR)~     subjects with cardiomyopathy with or without neuropathy.~   "
79538|NCT02016352|"~     PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal~     fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of~     100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.~   "
79539|NCT02016339|"~     The purpose of this study was to compare the effects on sleepiness, quality of life,~     depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP~     adherence, 2 years after CPAP initiation.~   "
79540|NCT02016326|"~     The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to~     an increased yield of adenomas in the colon among a population at increased risk for CRC.~      Primary Outcome:~      Adenoma Detection Rate (ADR — No. of colonoscopies at which one or more histologically~     confirmed adenomas were found divided by the total no. of colonoscopies performed in the~     same time period) in the right colon using High Definition White Light Colonoscopy Versus~     I-Scan enhanced Colonoscopy.~      Secondary Outcomes:~        -  Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan~          colonoscopy through out the entire colon.~        -  Adenoma Detection Rate (ADR) in the right colon during the Second look, irrespective~          of imaging modality.~        -  Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were~          found(regardless of the histological type) divided by the total no. of colonoscopies~          performed in the Same time period) for each arm of the study in Right colon and~          throughout the entire colon.~        -  Mean number of adenomas per procedure for each arm of the study in right colon and~          throughout the entire colon.~        -  Mean number of polyps per procedure for each arm of the study in right colon and~          throughout the entire colon.~        -  Number of neoplastic lesions for each arm of the study in the right colon and~          throughout the entire colon and number of neoplastic lesions missed on 1st pass of~          right colon.~        -  Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study~        -  Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the~          study~        -  Proportion of patients with Sessile Serrated Adenoma in each arm of the study~        -  Proportion of patients with invasive cancer in each arm of the study~        -  Presence or absence of learning effect while using this technology given that use of~          I-Scan may train the human eye to better identify adenomas even without image~          enhancement.~   "
79541|NCT02016313|"~     The purpose of this study is to determine whether physiotherapy is effective in the~     treatment of a group of tinnitus patients with neck complaints.~   "
79542|NCT02016300|"~     The study will examine clinical and radiographic outcomes of microfracture surgery (a common~     technique to address isolated areas of cartilage loss) in the knee used with or without~     unloader bracing. Randomly selected patients will wear an unloader brace, which is designed~     to take pressure off the area of the knee which underwent repair, for several weeks after~     surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.~      The surgery performed will be the same for all patients~      The length of follow up and schedule of post-operative MRI will be the same for all~     patients.~      The only difference in groups will be presence of absence of brace wear.~   "
79543|NCT02016287|"~     Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and~     majority of them were intolerable to combined chemotherapy in China. In the investigators~     phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and~     efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a~     definitive treatment for unresectable or medically inoperable tumors in ESCC patients.~     However, not only the combination with chemotherapy, but also the boundaries of the clinical~     target volume (CTV) are not internationally defined. The investigators then initiated a~     prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as~     the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy~     and safety of the combination.~   "
79544|NCT02016274|"~     Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients~     resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded~     before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to~     esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive~     treatment for unresectable or medically inoperable tumors in ESCC patients. However, not~     only the combination with chemotherapy, but also the boundaries of the clinical target~     volume (CTV) are not internationally defined. The investigators then initiated a prospective~     phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st~     line treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the~     combination.~   "
79546|NCT02016248|"~     The purpose of this study is to determine the side effects and how effective CyberKnife~     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The~     CyberKnife system is a new type of radiation machine that uses a special system to precisely~     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses~     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will~     be minimal. The purpose of this evaluation is to see if this treatment will help patients~     with your condition and to evaluate the effect of this treatment on your quality of life~     over time.~   "
79547|NCT02016235|"~     Patients with Dent disease have suppressed levels of FGF 23 which contributes to~     hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with~     phosphorus may reduce hypercalciuria.~   "
79548|NCT02016222|"~     In the primary progressive multiple sclerosis, the detection of oligoclonal bands in~     cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for~     cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that~     oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple~     sclerosis.~   "
79549|NCT02016209|"~     platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer~     (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and~     safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in~     neoadjuvant therapy.~   "
79550|NCT02016196|"~     TIPS has been used for 20 years, as a means of reducing portal pressure in patients with~     cirrhosis and portal hypertension related complications. TIPS proved more effective than~     alternative treatments in controlling or preventing variceal bleeding and refractory~     ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy~     (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history~     of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the~     incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.~   "
79551|NCT02016183|"~     To evaluate the safety and efficacy of long-term use of candesartan cilexetil /~     hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive~     patients in the routine clinical setting~   "
79552|NCT02016170|"~     Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a~     third generation thienopyridine, and ticagrelor, a first in class~     cyclopentyltriazolopyrimidine (CPTP). These agents have been shown to be associated with~     more potent platelet inhibitory effects compared with clopidogrel. In addition, both agents~     have shown to be superior to clopidogrel in preventing recurrent ischemic events in the~     setting of acute coronary syndromes (ACS). Understanding how to switch patients from~     prasugrel to ticagrelor is an unmet need of clinical interest. The proposed PD investigation~     will have a prospective, randomized, parallel design aimed to show that switching patients~     from prasugrel to ticagrelor provides similar levels of platelet inhibition.~   "
79553|NCT02016157|"~     In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated~     as an adjunct to scaling and root planing for efficacy in the treatment of chronic~     periodontitis and for short-term effects on the periodontal microflora.~   "
79554|NCT02016144|"~     This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic~     intubation and the equation to predict it.~   "
79555|NCT02016131|"~     Re-hospitalization or re-intervention is sometimes necessary to treat type I and type III~     endoleaks after EVAR for its persistent increasing of pressure in aneurysm lumen.~     Color-coded quantitative digital subtraction angiography (CQDSA) provides an easy and quick~     way to post-process the traditional digital subtraction angiography (DSA) which converts the~     peak time of the maximal contrast medium intensity into a single polychromatic image. With~     the help of CQDSA, a quantitative evaluation of the endoleak hemodynamics and a risk~     analysis of the type I or type III endoleak could be performed during the EVAR procedure.~     This approach may offer an objective assessment of the needs for immediate re-intervention,~     conservative therapy or treatment endpoint in the future.~   "
79556|NCT02016118|"~     The purpose of this study is to assess the effectiveness and costs associated with the~     intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS)~     compared to the current standard management of recurrent urinary tract infections in adult~     women diagnosed with recurrent urinary tract infections (RUTI).~   "
79557|NCT02016105|"~     The aim of the study is to demonstrate equivalent efficacy and similarity in the safety~     profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type~     psoriasis.~   "
79558|NCT02016092|"~     There are approximately one million Americans who live with Parkinson's disease with 50,000~     new cases per year and this rate is expected to rise with an aging population. The~     underlying pathophysiology and disease understanding of PD still remains elusive due to a~     combination of disease complexity and lack of predictive capability of existing models.~      The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in~     producing drug targets and biomarkers that truly represent a disease phenotype. It has been~     able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical~     candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS)~     diseases. The platform is able to decipher normal versus disease signatures by integration~     of data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that~     is subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then~     put back into wet-lab validation before proceeding to proof-of-principle pre-clinical~     testing.~      By utilizing clinical data and specimens obtained by the medical specialists at The~     Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover~     a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.~   "
79559|NCT02016079|"~     The primary purpose of this study was to assess the effectiveness of omega-3 supplementation~     on behavior problems in children.~   "
79560|NCT02016066|"~     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to~     the drug) and immunogenicity (ability of a particular substance to provoke an immune~     response in the human body) of CR6261 in Japanese healthy participants~   "
87145|NCT01916746|"~     The aim of this study is to further demonstrate the safety and effectiveness of transvaginal~     resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).~   "
79562|NCT02016040|"~     To evaluate the rate of patients without cancer detected by biopsies performed six months~     after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).~      Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at~     one year. Evaluate the cost of hemi-ablation HIFU treatment.~      A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory)~     offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven~     localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or~     T2b ). Precise mapping and characterisation of the disease will be established using~     multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.~   "
79563|NCT02016027|"~     AIMS & OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother~     tincture to healthy individual's Platelet count.~      Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic~     Medical College are taken up for the study. A minimum of 60 persons will be selected and~     will be divided into two groups, Control & Experiment by lottery method.~      Voluntary participation in the study is expected. 30 persons in each group. One group will~     receive Carica folia mother tincture and other group will receive placebo.~      Complete Blood count including platelet count will be measured for all 60 subjects before~     commencing the study.~      The drug namely Carica Folia mother tincture will be procured from Father Muller~     Homoeopathic Pharmaceutical Division which compiles with the standards of Homoeopathic~     Pharmacopeia of India.~      Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning~     and night for 3days.~      On 4th day complete blood count including platelet count will be estimated for all 60~     subjects.~      Research Methodology and Statistics:~      Pre &Post with Control Design is done. Data from the sample is collected and is subjected to~     Paired 't' test and unpaired 't' test.~      HYPOTHESIS:-~      Null hypothesis:~      No significant changes in complete blood count and platelet count before and after the~     intervention.~      Alternate hypothesis:~      There is significant variation in complete blood count and platelet count before and the~     intervention.~   "
79564|NCT02016014|"~     Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first~     step, and to evaluate the effect of adding this new tool of information and communication~     technologies (ICT), to a standardized intervention to increase adherence to nutritional~     recommendations of the Mediterranean diet and increase physical activity as primary~     endpoint. Analyze adherence and intervention results from a gender perspective. Methodology:~     Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at~     assessing the effects of adding an TIC tool, developed for the Smartphone application~     (intervention), in support of behavioral and educational recommendations (control) in the~     increased physical activity and adaptation to the Mediterranean dietary pattern. Population:~     1215 included subjects younger than 70 years from the project EVIDENT who agree to~     participate. Measurement and interventions: Physical activity will be assessed with the~     accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a~     questionnaire of adherence and a food frequency survey. It will also assess vascular~     structure and function, central blood pressure, Augmentation index, pulse rate and of~     carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on~     the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups.~     The intervention group will be added training and use of an application on a Smartphone~     designed to promote healthy eating and increased physical activity.~   "
79565|NCT02016001|"~     to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention~     after 18 months of randomized controlled trial.~   "
79566|NCT02015988|"~     To test the hypothesis that early (within 5-21 days after index event) administration of~     combined lipid-lowering therapy in extremely high risk population of patients with type 2~     diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary~     syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict~     requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG~     with diabetes.~   "
79567|NCT02015975|"~     Depending on the fracture pattern of patellar fractures tension band wiring,~     interfragmentary screw fixation or combinations are common treatments. But there are several~     problems associated with these techniques as fracture dislocation or loosening and~     perforation of the wire. Furthermore an anatomic reduction with stable fixation in~     comminuted fractures is almost impossible to achieve.~      A new option in the treatment of patellar fractures is the locking plate osteosynthesis,~     which provides a more stable fixation and higher mechanical strength in biomechanical tests~     compared to classic tension band wiring. Due to various screw positioning a stable fixation~     in comminuted fractures can be achieved and an early functional treatment with full weight~     bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems~     not to be essential anymore and the blood supply is not to be compromised.~      Because of the absent of clinical evidence investigators want to evaluate the clinical~     outcome after locking plate osteosyntheses in patellar fractures and compare patient~     satisfaction, functional motion, complications and number of revisions with common~     treatments.~   "
79568|NCT02015962|"~     Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of~     hypokalemia.~      Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between~     the two groups.~      Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as~     change in serum potassium levels in milliequivalent/L after potassium replacement)~   "
79600|NCT02015546|"~     This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10~     mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from~     generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the~     U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study~     is to evaluate the efficacy (how well the drug works), safety (the side effects), and~     tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of~     depression. As vilazodone is not approved by the United States Food and Drug Administration~     (FDA) to prevent the recurrence of depression, for the purposes of this study it is~     considered investigational. The word investigational means that the study drug is still~     being tested in research studies and has not been approved for this use by the FDA.~   "
79569|NCT02015949|"~     Traumatic brain injury (TBI) is the most common cause of death and disability in young~     adults. Patients can experience significant problems with concentration, attention, and~     memory (so called 'cognitive impairments') following TBI. These cognitive impairments can~     drastically impact on a patient's well-being, and can lead to significant economic and~     social consequences. Roughly a quarter of TBI patients improve but an equal number~     deteriorate over time. The investigators know little about why patients vary so much in how~     they recover. Crucially, the investigators have no treatments to improve brain functioning~     or recovery after TBI.~      Trials investigating ways of protecting the brain just after injury have been disappointing.~     An alternative strategy, however, is to improve the function of brain regions that remain~     intact, but that function inefficiently after TBI. The investigators know that dopamine (a~     chemical in the brain) is known to influence many brain functions and the investigators know~     that pathways in the brain that use dopamine are affected by TBI.~      In humans, drugs that increase dopamine in the brain, such as methylphenidate, are sometimes~     used to enhance cognitive function after TBI, but the response to treatment can be highly~     variable between patients. Therefore, what is needed in the clinic is a way to target the~     use of these drugs to patients who are likely to respond.~      In a single centre study, the investigators will use SPECT (Single Photon Emission~     Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance~     Imaging) scans will assess brain structure and function. The investigators will test whether~     treatment with methylphenidate improves cognitive functions in TBI patients who have ongoing~     cognitive problems, whether the mechanism involves a normalisation of brain functioning and~     whether brain dopamine levels can predict the magnitude of any improvement in symptoms.~   "
79570|NCT02015936|"~     The purpose of this study is to understand if a home-based physical activity program can~     improve symptoms and physical function among patients with advanced stage cancer.~   "
79571|NCT02015923|"~     Main outcome: Assess the impact of cancer-related survival at 2 years in patients with~     unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery~     followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity~     and mortality in patients treated with resection of the primary tumor. Assess complications~     and meed for surgery in patients treated with systemic chemotherapy only during the course~     of the disease. Identify and describe the complications related to chemotherapy and toxicity~     in the short and medium term systemic treatment. Assessing the quality of life questionnaire~     QLQ-C30 and QLQ-CR29. To study prognostic survival factors.~      Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to~     evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV:~     chemotherapy alone versus primary tumor resection plus chemotherapy.~      Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical~     resection of the primary tumor in stage IV colorectal patients with unresectable synchronous~     metastases increases by 14% overall survival compared to patients receiving systemic~     treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).~   "
79572|NCT02015910|"~     The primary objective of this study is to compare the rate of healing as well as percent of~     wounds healed in Type II diabetic patients with chronic foot ulcerations receiving~     sitagliptin versus placebo.~      The hypothesis for this study is that subjects receiving daily doses of sitagliptin in~     combination with their regular antihyperglycemic medications will result in increased~     healing rates as well as a greater number of healed wounds as compared to subjects receiving~     placebo and their regular antihyperglycemic medications.~   "
79573|NCT02015897|"~     The objective of this study is to investigate if Complete Decongestive Therapy is equally~     effective whether it includes manual lymphatic drainage or not in the treatment of~     lymphoedema among patients with breast cancer.~   "
79574|NCT02015884|"~     At the hospital, the attacks against health professionals are becoming commonplace, making~     working conditions difficult. The ophthalmological emergencies are a perfect testing ground~     to evaluate the effectiveness of a series of original actions to prevent the occurrence of~     violence against healthcare workers. The main objective is to measure the impact of an~     integrated prevention of the occurrence of antisocial behavior or attacks against the~     healthcare workers.~      The prevention program combines five interventions (steps): 1) a computer sorting algorithm~     and specific screens for calling patients in waiting rooms, 2) a clear signage to direct~     patients between waiting rooms, treatment rooms and administrative et medical offices, 3)~     Posts information on the activity of emergency services displayed on screens, in the waiting~     rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.~      This is an interrupted time series study. All patients admitted to the ophthalmological~     emergency unit of a university hospital located in Lyon, France, are included in the study,~     from June 2013 to Sept 2015~   "
79575|NCT02015871|"~     This trial is an open-label, multi-centre, single arm extension for the 000006 trial in~     Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day~     intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous~     (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients,~     who received goserelin treatment in the main trial, will get a degarelix starting dose (240~     mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this~     2-year extension trial is to collect long-term safety and tolerability data for the~     one-month dosing regimen.~   "
79576|NCT02015858|"~     Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the~     measurement of skin conductance.~      Withdrawal of chest tube can be painful and the purpose of the study was to compare~     auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.~   "
79577|NCT02015845|"~     The objective of this study is to evaluate the effectiveness of Accuvein to facilitate~     placement of peripheral intravenous catheters in obese patients. This clinical protocol is~     designed to determine whether using Accuvein increases the ease and efficiency of venous~     cannulation (as perceived by the operator), decreases the time to effective cannulation, and~     decreases the patient's perception of the pain.~   "
79578|NCT02015832|"~     Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in~     the functional assessment of patients with new coronary 3-vessel-disease who undergo~     percutaneous coronary intervention (PCI)~   "
79601|NCT02015533|"~     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to~     the drug) and immunogenicity (ability of a particular substance to provoke an immune~     response in the human body) of CR8020 in japanese healthy participants~   "
79602|NCT02015520|"~     The primary purpose of this study is to identify an appropriate dose of study medication.~   "
79603|NCT02015507|"~     To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the~     pharmacokinetics of VX-661 when administered in combination with ivacaftor~   "
91842|NCT01855061|"~     The purpose of this study is to determine whether it is possible to predict response to~     chemotherapy in patients with metastatic cancer who are treated with irinotecan by~     determining the mutational profile of the tumor.~   "
79579|NCT02015819|"~     This phase I trial studies the side effects and determines the best dose of genetically~     modified neural stem cells and flucytosine when given together with leucovorin for treating~     patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor~     in the brain. The neural stem cells that are being used in this study were genetically~     modified express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine~     (5-FC) into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more~     tumor cells. The CD-expressing neural stem cells are administered directly into the brain.~     After giving the neural stem cells a few days to spread out and migrate to tumor cells,~     research participants take a 7 day course of oral 5-FC. (Depending on when a research~     participant enters the study, s/he may also be given leucovorin to take with the 5-FC.) When~     the 5-FC crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out~     of the neural stem cells to preferentially kill rapidly dividing tumor cells while~     minimizing toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery,~     will be used to administer additional doses of NSCs every two weeks, followed each time by a~     7 day course of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer~     strategy may be an effective treatment for high-grade gliomas.~      Funding Source - FDA OOPD~   "
79580|NCT02015806|"~     The aim of this study is to determine whether adherence to oral maintenance medications~     differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,~     or none of these devices, with the hypothesis that low-touch devices improve adherence over~     control and that the increase in adherence is agnostic across devices.~   "
79581|NCT02015793|"~     The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of~     adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese~     subjects with Crohn's disease.~   "
79582|NCT02015780|"~     To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic~     control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in~     participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4~     or 5 on dialysis.~   "
79583|NCT02015767|"~     A patient registry to capture real life data and demonstrate the performance of roflumilast~     (Daxas®) in a standard clinical practice.~   "
79584|NCT02015754|"~     Purpose:~      The purpose of this study is to determine the feasibility and safety of using small beads~     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat~     patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded~     with irinotecan (DEBIRI-M1), and used to administer transarterichemoembolization (TACE).~      Eligibility:~      Patients with liver cancer from colorectal cancer.~      Study Overview/ Treatment:~      DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to~     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows~     for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the~     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into~     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and~     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and~     blood tests (to include assessment of liver function and tumor markers) and by imaging~     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they~     will be exited from the study and followed for survival. Once exited from the study they~     will continue to be eligible to receive DEBIRI, should it be recommended.~   "
79585|NCT02015741|"~     The assessment of anesthesia depth was based, until recently, on the evolution of~     hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived~     from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems,~     Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland~     Medical Devices Inc., Cleveland, OH 44103, USA).~      Use of such devices is discussed in aged patients. The purpose of this study is to compare~     Bispectral Index and NeuroSENSE during awake periods and during natural sleep.~   "
79586|NCT02015728|"~     This research study is a Feasibility clinical trial. In this trial, researchers are trying~     to figure out whether a medication can be chosen based on rapid testing done on tumor~     tissue. Information from a feasibility or pilot trial will hopefully help researchers plan~     larger trials in the future to determine the effect of this therapy.~   "
79587|NCT02015715|"~     This randomized, double-blind, placebo-controlled, single ascending dose study will assess~     the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, asian and~     caucasian volunteers. Volunteers will be enrolled in cohorts and randomized 8:2 to receive a~     single oral administration of RO6864018 or placebo. Total study time, including treatment~     and follow-up, is up to 9 weeks.~   "
79588|NCT02015702|"~     This study was intended to test the effects of adding a one-on-one educational intervention~     taught by a physician to a physician during their clinical work to improve their acceptance~     and satisfaction with a new inpatient electronic health record and ordering system.~   "
79589|NCT02015689|"~     The purpose of this study is to examine the impact of different message framing (i.e.,~     communication strategies) on parents' intentions to vaccinate their infants for measles,~     mumps, and rubella. We hypothesize that information specifically emphasizing various~     benefits of MMR vaccination will have different impacts on parents' reported levels of~     intention.~   "
79590|NCT02015676|"~     This study will define an optimal chemotherapy dose regimen of Myocet in combination with~     paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose~     regimen in patients with metastatic or locally advanced breast cancer and HER2~     overexpression. The anticipated time on study treatment is 3-12 months.~   "
79591|NCT02015663|"~     To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation~     Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic~     fibrosis.~   "
79604|NCT02015494|"~     One dose of escalating strengths of an investigational influenza vaccine VAX2012Q~     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for~     tolerability and immunogenicity in healthy adults 18-40 years of age.~   "
79605|NCT02015481|"~     The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous~     Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.~   "
79592|NCT02015650|"~     Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell~     carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis,~     increase in combination with radiotherapy. Mucositis, as a painful inflammation and~     ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one~     third of the patients discontinued Chemotherapy because of the side effects. Accordingly to~     these side effects, patients eating habits get limited. This requires an increase of pain~     medication, mostly an opioid derivate, which causes side effects too, which requires other~     symptomatic medication. This requires a change of nutrition from hard to pappy food and at~     further impairing, liquid food is needed. A central vein catheter has to be done for~     parental nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage~     and increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of~     general condition and a dose reduction or treatment stop is needed. Accordingly, the results~     are treatment delay and prolongation of hospital stay.~      Risk of the study will be the known side effects of the products: Mitomycin-C,~     5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product~     description and the description of radiation thera-py. Another risk would be that the~     primary objective cannot be fulfilled. So the patients would have a lower quality of life~     than expected. Following benefits are expected.~      Benefit for patient:~        -  Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste~          disturbances, dietary restrictions, dysphagia~        -  Decrease of pain medication and side effects caused by pain medication~        -  Decrease of surgical intervention (gastric tube, central venous catheter) and risks~          caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and~          stomach, etc.)~        -  Improving of patients social functioning, social eating, social contact~        -  No interruptions of therapy~        -  Increase of life quality~        -  Weight stabilization~      Benefit for clinical practice:~        -  Increase of compliance~        -  Fulfilling of complete therapy~        -  Hospital stays as planned~   "
79593|NCT02015637|"~     The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin~     versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated~     cervical, urethral, rectal, or pharyngeal gonorrhea.~   "
79594|NCT02015624|"~     This register will evaluate the use of different antithrombotic therapies, combinations of~     different drugs routinely used during any stage of hospital admission, with their timing,~     dosage and mode of administration, in patients with a diagnosis of Acute Coronary Syndrome~     in the Italian Coronary Care Unit during a study period of three weeks~   "
79595|NCT02015611|"~     The purpose of this study is to see if vitamin D supplementation improves muscle function.~   "
79596|NCT02015598|"~     Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper~     airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was~     postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study~     suggest that ischemia-reperfusion represents an oxidative stress causing increased~     generation of reactive oxygen species, especially superoxide anions.It is one of the most~     important mechanisms of cardiovascular diseases, including hypertension, coronary artery~     disease and cerebrovascular accident complication with OSAS.So many individuals approve OSAS~     is an Oxidative Stress disease.~      Continuous positive airway pressure (CPAP) is the first-line of treatment method in~     moderate/severe OSA.But poor adherence to CPAP treatment is very common.The failure rate~     with CPAP treatment is more than 50%.So we are searching a new treatment for that patients.~     Carbocysteine is a antioxidant.It can not only scavenges the free radicals but also~     replenishes glutathione(GSH)which is has double antioxidant capacity. However, Carbocysteine~     is cheaper than other which has double antioxidant capacity drugs,such as~     N-acetylcysteine.The purpose is to evaluate efficacy of oral intake of Antioxidant~     Carbocysteine witch can reduce oxidative stress and improve the symptom of OSAS.It recover~     the imbalance in the oxidant-anti-oxidant status may reduce cardiovascular abnormalities in~     Patients with OSAS.~   "
79597|NCT02015585|"~     The edentulism and use of inadequate dentures, unstable and with teeth worn because long~     period of usage can lead to an disharmony of the stomatognathic system due to gradual loss~     of occlusion vertical dimension resulting in inadequate mandibular movements and~     condyle-fossa relation. The reline of the denture base and the use of interocclusal~     appliance prior to definitive rehabilitation could have influence on these functional~     aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the~     combined use of these two treatments in reestablishing these functional aspects. The, aim of~     this study is to evaluate whether the denture base reline and the use of interocclusal~     appliance prior to final rehabilitation have influence on mandibular movements and~     condyle-fossa relation, incomplete denture wearers. For this controlled, crossover,~     randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture~     wearer over a period of five year, will be selected. The volunteers will be randomly~     allocated into three subgroups (n= 10) and will receive the following treatments: Control~     (C)Volunteers will receive new complete denture without any previous intervention in their~     old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of~     the base of the their old complete denture and after 30 days of usage and before the~     replacement of the new complete denture, an evaluation will be performed; Interocclusal~     Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance~     and after 30 days of usage and before the replacement of the new complete denture, an~     evaluation will be performed. Volunteers will be evaluated regarding the extent of~     mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by~     cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and~     photographic record. These evaluations will be performed at three periods, T0 baseline; T1~     after application of randomized treatment, reline denture and interocclusal appliance); T3~     after final rehabilitation. The control group will be evaluated only at periods T0 and T3.~   "
79598|NCT02015572|"~     Low back pain (LBP) is a recognized public health problem with high life time prevalence.~     Medical treatment may reduce the physical and mental discomfort, while it has not been able~     to improve the possibilities for retaining or return patients with LBP to work.~      This is an occupational intervention study for patients with LBP and physically demanding~     work, who are at risk of drop out of labour; a randomized controlled trial designed to test~     the effectiveness of an early intervention for retaining subjects with LBP attached to the~     labour marked. A work place modification intervention combined with moderate physical~     activity is given in the intervention group additional to LBP treatments according to best~     practice recommendations for general practice.~      The study population consists of patients in self-reported physically demanding, who are~     sick listed or at risk of sick leave due to LBP. Outcome will continually be collected~     during the intervention as well as 6 and additionally at 12 months follow up.~      The primary aim is to evaluate if an occupational intervention with focus on early workplace~     orientated counselling and work place intervention can retain subjects with physically~     demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.~      The secondary aims are to identify prognostic factors of an occupational intervention using~     the baseline and follow-up participant-rated outcomes: pain, physically function, generic~     health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with~     intervention, clinical examination and MRI findings. Among these variables, we also aim to~     identify subjects, who will benefit from such an occupational intervention, and the~     subjects, who already have a good prognosis and therefore have no need for a larger scale~     intervention.~   "
79599|NCT02015559|"~     This randomized phase II trial studies how well mucoadhesive oral wound rinse works in~     preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone~     receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed~     by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of~     stomatitis, or mouth sores, in patients receiving everolimus.~   "
91843|NCT01855048|"~     The Objectives of this study is to evaluate the safety, pharmacokinetics and~     pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.~   "
79606|NCT02015468|"~     A prospective, randomized study investigating the possible benefits of immediate~     mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.~      The current study will test the following null hypothesis:~      There is no significant difference between patients who receive a cast for the first 2 weeks~     postoperatively and then instructions in home exercises and patients who receive a cast for~     2-3 days postoperatively and then have frequent sessions with a physiotherapist following~     volar locked plating for a extraarticular distal radius fracture, as evaluated by~     self-reported satisfaction after 3 months.~   "
79607|NCT02015455|"~     The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a~     large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a~     simple, inexpensive and easy to deploy intervention - insertion of epidemiological~     benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments.~     The investigator's main hypothesis is that for patients referred from primary care~     providers, inserting epidemiological evidence in lumbar spine imaging reports will reduce~     subsequent diagnostic and therapeutic interventions, including cross-sectional imaging~     (MR/CT), opioid prescriptions, spinal injections and surgery.~   "
79608|NCT02015442|"~     AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men~     with liver fat levels below 5%~      DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4~     week wash-out period. Dietary intervention will be based on iso-energetic substitution of~     sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high~     sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK~     intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy~     intake. Otherwise the macronutrient balance in both conditions will be based on UK average~     habitual intake.~      POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2,~     with normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin~     resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal~     disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of~     subjects to range from sedentary to a maximum of meeting the UK minimum activity~     recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2~     units per day.~      TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by~     completion of a 7-day food diary and be asked to wear an accelerometer armband to assess~     physical activity before each intervention week. Resting energy expenditure will also be~     assessed by indirect calorimetry.~      7 day dietary interventions: Participants will be resident at the clinical research facility~     at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food~     will be provided at the facility. At the weekends, participants will have to leave the unit~     but food will be provided for those two days so that the diet can be continued at home.~      At the start and end of each 7 day intervention: Weight, height and waist circumference will~     be taken; percentage liver fat and total and regional body composition will be measured by~     MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood~     pressure.~   "
79609|NCT02015429|"~     The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to~     together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response~     to the meal compared to a meal without yellow pea components and reduce food intake at a~     meal served 2 hours later.~   "
79610|NCT02015416|"~     This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical~     safety and immune response of IDC-G305 when injected intramuscularly in patients with~     unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant~     NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's~     immune system to fight the spread and growth of cancer for patients whose tumors include the~     NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer~     may be considered for the trial.~   "
79611|NCT02015403|"~     Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences)~     emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care~     Unit) in view of upper GI bleed randomized to two groups~      GROUP A : 70 Patients will receive standard care + NAC infusion for 72 hours~      GROUP B : 70 Patients will receive standard care only~      NAC will be given at following rate :~      Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then~     continuous infusion of 6.25 mg/kg for the remaining 67 hrs~   "
79612|NCT02015390|"~     The United States Department of Defense (DoD) is funding exciting new research at the~     University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and~     Rehabilitation that can be a major improvement in the treatment of extremity trauma~     involving segmental bone loss. These devastating injuries occur frequently in both civilians~     and the military. They typically result from motor vehicle accidents, high-energy fractures,~     gunshot injuries, and blast injuries, but also from the surgical removal of a bone segment~     because of infection or tumor. Despite many modern medical advances in this area, bone~     healing that can adequately replace bone loss and restore pre-injury limb function is~     extremely difficult to achieve. Existing standard treatment procedures are exceedingly~     complicated, require highly specialized equipment and clinical skills, and usually require~     many surgical procedures over many months or years. Despite these effort and costs, major~     complications usually occur with all the standard treatment options, the patient's ability~     to return to an acceptable functional status is typically low, and, therefore, many of these~     patients have their limbs amputated.~      The UTMB Department of Orthopaedic Surgery and Rehabilitation will conduct a DoD-funded~     clinical trial to determine and compare the advantages of two new and innovative surgical~     bone defect treatment techniques that can be significantly more effective for wounded~     warriors or civilian patients and with these conditions. One treatment method, called the~     Masquelet Technique, involves two-stage surgery: the first one to create a biomembrane~     around the defect by applying a cement spacer, and then the second one for cement spacer~     removal and defect bone grafting. The other method, developed by UTMB physicians, is the~     Cage Technique and it comprises one-stage surgery in which a special hollow, fenestrated,~     titanium cage filled with bone graft is implanted in the defect. Initial clinical experience~     with both of these techniques has been very promising, but to date, there has been no~     prospective clinical study comparing the two new methods of defect treatment. Identifying an~     optimal surgical bone defect reconstructive technique would significantly improve the~     clinical outcomes of patients with these challenging conditions.~   "
79613|NCT02015377|"~     The overall objective of FAME is to examine the metabolic and behavioral links between~     dietary intake and its subsequent effects on circulating appetite regulating hormones and~     physical activity levels in Hispanic and African American adolescents.~   "
79638|NCT02015039|"~     Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of~     botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of~     rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together~     with a specific type of occupational therapy will be better than BoNT alone for treating~     these patients. Additionally, studies on WC were hampered by the lack of objective,~     validated rating scales. In this pilot study, we will assess the value of a new scale~     compared with older scales.~      Study population: The study population will consist of 12 WC patients (accrual ceiling of~     16).~      Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6~     patients will receive BoNT therapy plus occupational therapy. The physical therapy will~     involve specific exercises of finger movements in the direction opposite to the patient s~     own dystonic movements, during the writing task. The movements will be isometric against~     splints made to suit the individual patient. The final outcome will be assessed after 20~     weeks of treatment. Patients will be evaluated on several scales, including the writer s~     cramp rating scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be~     videotaped. The primary outcome will be based on patient reported subjective scale and the~     secondary outcomes will be assessed by four blinded raters of the videotapes, done both~     before and after treatment.~      Outcome measures: The primary outcome is to show additional improvement from baseline with~     BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a~     patient-rated subjective scale. The secondary outcomes are to show improvement in scores of~     WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.~     Additionally, the scores obtained from WCRS and WCIS will be compared.~   "
79639|NCT02015026|"~     Background:~        -  Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per~          million people per year. It has a very poor prognosis with an overall 5-year mortality~          rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months.~        -  The treatment of choice for a localized primary or recurrent tumor is surgical~          resection.~      Patients with recurrent or metastatic disease are infrequently curable by surgery alone.~        -  As with most solid tumors, chemotherapy options have limited benefit, although~          platinumbased therapies have response rates of 25 to 30%. To date no targeted therapy~          has been shown to be of any value in this disease.~        -  The natural history of ACC can vary greatly with some patients surviving only months~          while others can live with disease for years. The basis for these differing clinical~          presentations is not known. While one cannot exclude an immune or other host component~          as responsible for the diverse clinical courses, it is also possible that there may be~          a genetic basis for this phenomenon. A bio-specimen repository will be a major step~          towards more comprehensive studies of this very rare and unusual tumor, and allow us to~          begin to characterize subgroups within the disease.~        -  Patients with rare tumors seek expert advice in the management of their care. Dr. Fojo~          has such expertise and is frequently asked to consult in the care of ACC patients~          throughout the world. A natural history study would establish a more formal mechanism~          for such referrals, while allowing the systematic collection of epidemiologic data as~          well as much needed tumor samples.~      Objective:~      -To characterize the natural history of adrenocortical cancer, and in the process, collect~     blood, and tissue samples to study genetic/biochemical pathways involved in the development~     and progression of adrenocortical cancer (ACC).~      Eligibility:~        -  Patients greater than or equal to 12 years of age with biopsy-proven ACC~        -  Patients greater than or equal to 12 years of age suspected of having ACC~      Design/Schema:~        -  Patients will be offered clinical consultation with treatment recommendations,~          including standard of care and clinical trial options. Computed tomography scans of the~          thorax, abdomen and pelvis will be performed for staging purposes as indicated;~          occasionally, magnetic resonance imaging will be performed for the visualization of~          lesions in the liver, spine, or other anatomic sites.~        -  Medical histories will be documented and patients followed throughout the course of~          their illnesses, with particular attention to patterns of disease recurrence and~          progression, response to therapies, duration of responses and hormone production in~          patients with hormone production as a manifestation of their disease. Tumor growth~          rates will also be calculated throughout the course of the disease.~        -  Blood and tumor samples will be obtained at baseline and at follow-up intervals when~          surgery is indicated. Tumor samples may include samples harvested at other facilities~          during or prior to enrollment on this trial.~        -  Genetic and epigenetic analysis of tumors and in selected cases expression array~          analysis will be performed.~   "
79614|NCT02015364|"~     Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8~     affects the functional outcome and patient reported outcome after treatment of acute~     Achilles tendon rupture.~      Type of study~      Randomized, controlled trial (RCT). 130 patients will be included.~      Time schedule~      Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years~      Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are~     treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage~     is changed to a removable orthosis and full weight bearing is allowed.~      Patients who choose to participate in the trial will - through randomisation - be placed in~     one of the two groups:~        1. The intervention group: Must perform controlled mobilization-exercises from the~          beginning of week 3.~        2. The control group: In line with the current treatment regimen the patients must keep~          the boot on at all times and they are not allowed to move the ankle.~      Treatment protocol for the two groups is similar concerning orthose, removal of wedges and~     weight-bearing. The only difference is that patients in the intervention group are~     instructed to do ankle exercise.~      Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12~     months. The study's primary endpoint is at the 12 month mark.~      Population Patients who are treated for acute Achilles tendon rupture at Copenhagen~     University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to~     participate are treated according the standard regimen (non-operatively without early~     controlled movement of the ankle joint).~      Number of patients 65 patients will be included in each group (a 130 patients in total).~   "
79615|NCT02015351|"~     Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated~     to systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal~     neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up.~     Outcome measures: improvement of VA, decrease in central foveal thickness as measured by~     Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.~   "
79616|NCT02015338|"~     Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to~     determine the brain area that controls hand function will not differ from TMS-guided~     determination of individual motor hotspots. In children with hemiparesis, however, those two~     locations will diverge. The prediction is that TMS will best guide tDCS interventions~   "
79617|NCT02015325|"~     The objective of the study is to evaluate the impact of the Planet Water Foundation's~     intervention to improve Water, Sanitation and Hygiene related illness for reducing~     absenteeism and diarrheal episodes among school children resulting in improvement of their~     learning performance and ultimately long term economic prosperity.~   "
79618|NCT02015312|"~     Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid~     light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest~     posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.~   "
79619|NCT02015299|"~     Diabetes is associated with an increased risk for developing premature macrovascular~     complications. The process of irreversible subclinical damage to the vasculature already~     starts during its preceding stages. Dipeptidyl peptidase (DPP)-4 inhibitors have been shown~     to attenuate vascular damage in preclinical studies. Off-target effects on adipose tissue~     inflammation, liver steatosis and atherosclerotic plaques have been extensively documented~     in animal studies.~      Based on these considerations the investigators hypothesize that early therapy with the DPP4~     inhibitor linagliptin in subjects with treatment naive type 2 diabetes will lead to~     beneficial effects on arterial stiffness as measured by pulse wave velocity.~   "
79620|NCT02015286|"~     This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth~     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
79621|NCT02015273|"~     This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long~     Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for~     growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®~     via easypod™.~   "
79622|NCT02015260|"~     Objective To assess the efficacy of the topical application of Nitric Oxide, delivered using~     acidified nitrite.~      Design Multicentre, randomized, controlled, dose ranging trial. A control arm and three~     doses of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow~     up.~      Setting The trial setting was in European genitourinary medicine clinics~      Participants Male and female volunteers over 18 years of age with between 2 and 50~     ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were~     randomised.~      Exclusions Pregnancy; concomitant Sexually Transmitted Disease; internal warts requiring~     treatment other than surgery /laser; diabetes ; Human Immunodeficiency Virus-positive,~     immunosuppressed and/or using immunosuppressive therapies; drug abuse.~      interventions compared~        -  Control Placebo nitrite cream and placebo citric acid cream twice daily~        -  A) 3% sodium nitrite + 4.5% citric acid creams twice daily~        -  B) 6% sodium nitrite + 9% citric acid creams once daily~        -  C) 6% sodium nitrite + 9% citric acid creams twice daily~      Outcomes~        -  Primary proportion of patients with complete clearance of target warts Secondary~        -  Time to clearance~        -  Wart area~        -  Wart count~        -  Patient and investigator assessment of efficacy~        -  Safety~        -  Tolerability~        -  Adherence~   "
79648|NCT02014909|"~     Part I will evaluate the pharmacokinetic profile and safety of KTN3379 over several doses~     with the objective of defining a Phase 2 dose in patients with advanced malignancies. Part~     II will evaluate the pharmacokinetic profile and safety of KTN3379 in combination with other~     targeted agents and obtain preliminary evidence of anti tumor activity in specific types of~     cancer. Patients will continue receiving KTN3379 alone or in combination until disease~     progression or toxicity that necessitates discontinuation (whichever comes first).~   "
79716|NCT02014025|"~     The purpose of this study is to compare short-term and long-term efficacy of laparoscope~     hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope~     hepatectomy the PHC with a tumor size of 5～10㎝,and provide class B evidence based medicine~     for laparoscope hepatectomy for PHC with a tumor size of 5～10㎝.~   "
79623|NCT02015247|"~     Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by~     genetic and intrauterine factors, such as mechanical (rump presentation and oligohydramnios)~     and hormonal factors1. To ease the passage through the birth canal, the hip joint is quite~     mobile perinatally. Postnatally, the laxity of the ligaments will subside and the femoral~     head will normally position itself deeply in the acetabulum2. The theory is that if the~     femoral head does not migrate sufficiently into the acetabulum, dysplasia may develop~     because the matrice to stimulate acetabular growth is not correctly positioned. Normally, at~     birth the femoral head sits deep in the acetabulum held by surface tension of the synovial~     liquid. The growth and the hemispherical morphology of acetabulum are dependent on the~     presence of a normally growing and correctly placed spherical femoral head that works as a~     convex matrice. If for some reason the normal development is disturbed pre- or postnatally,~     pathologic relations may develop between the femoral head and the acetabulum3, leading to~     hip dysplasia.~      Purpose of this research project is to investigate if the correction of the acetabulum is~     accurately performed when the surgeon use navigation equipment during PAO.~   "
79624|NCT02015234|"~     This is a Phase 3, open-label, extension trial designed to evaluate the long-term safety~     over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of FM.~     Patients recruited into this trial are those who have successfully completed the~     double-blind study, TNX-CY-F202 (F202). Patients will not be made aware of the therapy they~     received during the double-blind study.~   "
79625|NCT02015221|"~     The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual~     action pneumatic compression device in patients with unilateral or bilateral chronic venous~     insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.~   "
79626|NCT02015208|"~     The purpose of this study is to determine if Ruxolitinib, an inhibitor of~     cytokine-signaling, is effective in the treatment of patients with Chronic Lymphocytic~     Leukemia for whom conventional chemotherapy is either too toxic or ineffective.~   "
79627|NCT02015195|"~     The purpose of the study is to attempt to determine which treatment from commonly used~     treatments is the best at reducing pain and redness of the skin after a sting from a~     Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.~      Jellyfish stings are a common occurrence in many parts of the world causing significant~     morbidity to persons stung by jellyfish while participating in marine activities whether~     commercial or recreational. Much debate and confusion exist both in the medical literature~     and the common recommendations regarding how to treat persons stung by jellyfish.~     Specifically concerning what topical treatments are most efficacious at decreasing~     envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst,~     decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal~     recommendations and past studies have referenced numerous different topical treatments for~     jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits,~     ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old~     wine, salt water, cold packs, hot water, and commercial products such as Stingose and~     Stingaid. Conflicting data exists regarding what works and what does not for nematocysts~     discharge, skin erythema, and pain reaction.~      The investigators would like to investigate which treatment is best out of some of the more~     commonly studied treatments for reducing pain and erythema.~      The investigators would like to complete a research study to try to bring some reasonable~     evidence to the field treatment of jellyfish stings, namely, the decontamination process~     (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).~      The questions asked are as follows:~        -  What topical treatments for jellyfish stings actually decrease the amount of~          inflammation seen on a macroscopic level on the skin of humans?~        -  What topical treatments for jellyfish stings actually decrease the sensation of pain in~          humans?~        -  Do topical chemical treatments cause different outcomes when exposed to the above~          parameters?~        -  Do different species of jellyfish nematocysts react differently based on the type of~          topical chemical treatment used? What is the variation of effects of topical treatments~          based on the species of jellyfish sting?~      Specifically, the investigators will be stinging human subject on both arms with a segment~     of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm~     (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium~     bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%),~     isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will~     include pain and erythema.~   "
79628|NCT02015182|"~     The aims of this study are to determine population PK parameters of bupivacaine in children~     following TAP block using a population-based PK approach, and to evaluate the influence of~     patient covariates on drug disposition.~   "
79629|NCT02015169|"~     We planned this study to investigate the efficacy and safety of XELOX (capecitabine and~     oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver~     metastasis.~   "
79630|NCT02015156|"~     This study is to prove that there is no difference in the number of healthy male volunteers~     that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a~     24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab~     sourced from the United States (trastuzumab-US). The study will also compare the safety of~     both drugs.~   "
79631|NCT02015143|"~     The purpose of this study was to investigate the reliability and validity of the bipolar~     index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying~     bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar~     disorder in natural status.~   "
79632|NCT02015130|"~     The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark~     approximately 8% of adults have T2D and more than 25.000 are diagnosed each year. This has~     vast consequences for society and the patient.~      Standardized treatment aiming at normalizing blood glucose and hypertension comparable to~     healthy individuals, have been tested in large studies. The effect on cardiovascular disease~     and other complications have been modest at best and one study showed an increased mortality~     with intensive treatment. The standardized treatment often results in polypharmacy, which~     increases the risk of patients discontinuing treatment.~      We propose a new approach to treatment of T2D, where the patients' individual~     characteristics are considered. The aetiology of the diabetes can be different, which~     warrants different treatment. Many patients have concomitant illness which can affect the~     way the patient is treated. A tight regulation of blood glucose can in some patient~     constitute a risk of adverse effects, especially hypoglycemia. In that sense individual~     targets for the treatment are important. Effective lifestyle treatment has importance for a~     successful outcome and we therefore offer an application that can help the patient and the~     physician organizing activity individually.~      The objective of individual treatment is to choose the most effective medication. If a~     prescribed drug does not have the desired effect it should be replaced with a different~     drug. The overall goal is to reduce the number of substances and side-effects, but~     simultaneous improve treatment and reduce the incidence of cardiovascular and other~     diabetes-related complications. This will in turn result in improved quality of life and~     improved adherence to treatment.~      The potential effect of individual tailored treatment of T2D is to improve the guidelines of~     treatment, not only to improve the patients' health, but also to reduce the socioeconomic~     consequences of the growing T2D prevalence~   "
79633|NCT02015117|"~     This phase I trial studies the side effects and best dose of trametinib with or without~     whole brain radiation therapy in treating patients with brain metastases. Trametinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Radiation therapy uses high energy x rays to kill tumor cells. Drugs, such as trametinib,~     may make tumor cells more sensitive to radiation therapy. Giving trametinib with whole brain~     radiation therapy may be a better treatment for brain metastases.~   "
87380|NCT01913613|"~     The objective of this clinical study is to evaluate the safety and performance of the IASD~     System II in the treatment of heart failure patients with elevated left atrial pressure, who~     remain symptomatic despite appropriate medical management.~   "
79634|NCT02015104|"~     Background:~      - Many cancers produce two particular proteins. The immune system can target these to attack~     the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the~     body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on~     people with high grade non-muscle invasive bladder cancer. They will give it to people who~     have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several~     weeks. They want to see if PANVAC plus BCG is better than BCG alone.~      Objective:~      - To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone.~      Eligibility:~      - Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least~     1 course of BCG.~      Design:~        -  Participants will be screened with blood and urine tests and abdominal scans.~        -  Participants will be randomly assigned to get BCG only or BCG plus PANVAC.~        -  They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer~          care.~        -  They will have blood and urine tests.~        -  All participants will get BCG in 6 weekly injections.~        -  One group will also get PANVAC in 5 injections over 15 weeks.~        -  Between weeks 17 and 20, participants will undergo tests of the tumor area as part of~          their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy.~          Results will be used to evaluate the different treatments.~        -  Participants will have quarterly follow-up visits for up to 2 years.~   "
79635|NCT02015091|"~     Background:~      - People bitten by mosquitoes carrying weakened malaria parasites could fight off the~     disease if later exposed to normal malaria parasites. Scientists have discovered how to make~     the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see~     if people who receive the vaccine get malaria after being bitten in a controlled setting (a~     controlled human malaria infection, CHMI).~      Objective:~      - To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.~      Eligibility:~      - Healthy adults 18 45 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, blood and lab tests,~          and EKG.~        -  Participants will be split into 8 groups, to be in the study for 3 12 months.~        -  Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or~          muscle.~        -  Participants will keep a health diary and be contacted by phone.~        -  For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5~          minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be~          exposed to malaria more than once.~        -  After CHMI, participants will visit the clinic very frequently (including daily visits~          for 12 days) for 28 days.~        -  Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical~          history may also be repeated~        -  Participants who develop malaria will be treated immediately at the clinic. Standard~          treatment takes 72 hours. Malaria symptoms may last up to 3 days.~   "
79636|NCT02015078|"~     Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to~     public health recommendations for maintaining healthy eating is low. Insights gained from~     weight loss intervention trials find that trial participants report difficulty in~     restricting calories, dissatisfaction with the pace of weight loss, inability to control~     eating, low palatability of recommended foods and strong food cravings. Indeed, recent~     systematic reviews provide empirical support that these subjective experiences that trial~     participants describe likely represent eating-related traits or phenotypes . While amassing~     evidence supports individual variation in these eating-related traits, to date there has~     been no systematic effort to characterize robust eating-related phenotypes. Proposed is a~     Sub-study initially planned to be piggy-backed on a planned Study being conducted by~     investigators at the University of North Carolina (UNC-- Linnan, Dilworth- Anderson &~     Evans). The UNC Parent Study was a feasibility study using community-based participatory~     research (CBPR) approaches to explore possible intervention strategies aimed to reduce the~     burden of chronic disease and cancer among African American families. The NHGRI-led eating~     behavior Sub-study is proposed to be integrated with the UNC Parent Study (hereafter~     referred to as Phase 1). The additional aims of the Sub-study (hereafter referred to as~     Phase 2) are to gain understanding of whether we can characterize clusters of eating-related~     behaviors that may be associated with adherence to weight management and weight outcomes.~     This current protocol lays out the specific qualitative activities planned for Phase 1 which~     include conducting structured interviews with Black Family Reunion organizers (N=8) and a~     sample of reunion participants (N=40). We also describe the larger quantitative survey~     proposed for Phase 2. Pending the feasibility of the sub-study with the African-American~     community, we will collect information on eating-related behaviors in a large sample of~     individuals (N=350). If the initial assessments (Phase1) prove that this is not a viable~     study to be conducted in that setting, we will consider other population groups and other~     settings.~      We are also considering Phase 3 activities if we identify clusters of eating-related~     phenotypes within individuals. Amended IRB applications will be submitted prior to launching~     Phase 3.~   "
79637|NCT02015065|"~     Background:~      -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in~     one of their proteins called SDH. Vandetanib is a cancer drug that has been approved to~     treat thyroid cancer and has been used with some success in other tumors that have a similar~     loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people~     with WT-GIST.~      Objectives:~      -To test whether the study drug will benefit people with WT-GIST.~      Eligibility:~      -Adults and children 3 years old and older with WT-GIST.~      Design:~        -  Researchers will test participants tumor tissue to confirm it is the wild type of GIST.~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          They will also have electrical recording of the heart (ECOG) and scans of the tumor.~        -  Participants will take the study drug in 28-day cycles. Their doctor will decide how~          many cycles they can complete.~             -  They will take the study drug once every day and record it in a diary.~             -  On Day 14, they will also visit their doctor to look for side effects.~        -  Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood~          pressure check, and blood tests. These tests will then be done periodically for as long~          as they are in the study.~        -  Before cycle 4, scans will be done to check the size of the cancer. Most of these will~          be repeated every 3-6 cycles.~        -  When they stop taking the study drug, participants will return to the clinic for a~          physicial exam and blood tests.~   "
79649|NCT02014896|"~     The proposed study will validate the clinical use of new biomarker blood tests to identify~     blood components that may differentiate between diverse stroke etiologies and clinical~     outcomes as listed below:~        1. Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes,~          when hemorrhagic stroke is ruled out.~        2. In cases of ischemic strokes of unknown or cryptogenic etiology, determine the~          ability of biomarker blood tests to predict etiology between cardioembolic and large~          artery atherosclerotic.~        3. In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic~          ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by~          AF.~        4. Differentiate transient ischemic attacks (TIAs) from acute ischemic strokes.~        5. Differentiate TIAs from non-ischemic transient neurological events (TNE) with similar~          symptoms.~   "
79640|NCT02015013|"~     Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T~     cell counts (<300/mm3) without evidence of HIV infection or other known immunodeficiency.~     Patients with ICL are at risk for opportunistic infections typically associated with~     HIV/AIDS such as disseminated cryptococcal infection and severe human papillomavirus-related~     dysplasia. More than 20 years since the description of ICL, its etiology, pathogenesis, and~     management remain unclear. In this study we propose to administer the combination of~     granulocyte colony stimulating factor (G-CSF) and plerixafor to ICL patients and healthy~     volunteers with the objective of harvesting mobilized CD34+ hematopoietic progenitor cells~     (HPCs) by apheresis for transfer into immunocompromised mice and for study with in vitro~     assays. The mice studies would serve to investigate thymic development, survival, and~     trafficking of the mobilized human cells within murine lymphoid and non-lymphoid organs.~      HPCs are used for various therapies and there is an increasing use of agents that stimulate~     the bone marrow to produce progenitor cells and move them into the bloodstream where they~     may be harvested by apheresis. Not all patients respond to GCSF with vigorous HPC~     mobilization. The binding of chemokine receptor CXCR4 to stromal cell derived factor (SDF-1~     or CXCL12) is an important interaction between a hematopoietic progenitor cell and its~     marrow environment. Plerixafor is a CXCR4 inhibitor which blocks binding to SDF-1 resulting~     in the release of hematopoietic progenitor cells (CD34+) into peripheral circulation. In~     pharmacodynamic studies of plerixafor in conjunction with G-CSF compared to G-CSF and~     placebo, a two-fold increase in CD34+ cell count was observed.~      Due to the important role CXCR4 plays in immune cell trafficking and its potential role in~     the pathogenesis of ICL, we propose as a secondary objective to assess peripheral CD4 T cell~     and CD34+ hematopoietic progenitor cell numbers and functions in ICL patients compared to~     controls following G-CSF and plerixafor administration.~      Study participants will be screened within 12 weeks prior to the study period. Eligible~     participants will receive G-CSF for 5 days with hospitalization on Day 4 for plerixafor~     injection followed by apheresis on Day 5. Participants will return for examinations and~     blood draws on Days 8 and 12.~   "
79641|NCT02015000|"~     The treatment of pterygium is still quite controversial. Previous studies using a large~     incision for pterygium excision and a large graft and has reported a very low recurrence~     rate with the P.E.R.F.E.C.T. technique. However, the P.E.R.F.E.C.T. technique is a~     relatively lengthy procedure and may not be suitable for patient with limited conjunctival~     reserve. Thus, we try to evaluate the final outcome of a sutureless amniotic membrane~     transplant technique combining the extended pterygium excision in hope to avoid the~     complication of the P.E.R.F.E.C.T. for PTERYGIUM technique.~   "
79642|NCT02014987|"~     About 31% of the Danish population participates regularly in running. The positive health~     benefits of running have been well documented in the literature. Unfortunately, running has~     been connected with a high risk of injuries.~      Running related injuries can cause a long rehabilitation and may even force the runner to~     quit running permanently. To ensure that running can be practiced as a safe exercise~     activity prevention must be considered.~   "
79643|NCT02014974|"~     Background: Worldwide injuries from trauma accidents represents a major population problem.~     The World Health Organization (WHO) has deemed this problem as one of the most important~     global priorities, calling 2011-2021 the Global Road Traffic Safety Decade. Despite this,~     there is little empirical data in low and middle-income countries quantifying the burden of~     fractures and the current practice of care.~      Methods: We conducted a multicenter, prospective observational study of patients sustaining~     fractures or dislocations who presented to an orthopaedic fracture unit at 14 hospitals in~     India. A representative sample of patients were recruited during an 8-week period starting~     on October 1, 2012. Patients were followed up to 30-days in hospital or until discharge to~     determine if they suffered any outcomes. Primary outcomes included total mortality,~     reoperation, and infection.~   "
79644|NCT02014961|"~     Quest for modifier genes associated with ventricular arrhythmias in presence of a cardiac~     sodium channel gene (SCN5A-delPhe1617) mutation.~   "
79645|NCT02014948|"~     The lumbar spine is currently one of the most affected areas by nociceptive processes ,~     referred back pain, which can be provided from a herniated intervertebral disc . Such~     conditions are considered a public health problem , since considerably affect the population~     , mainly young adults , which may lead to functional disability and absenteeism . Soon , his~     treatment involves high costs and rehabilitation time indefinite , generating great~     scientific interest focused on the search for new techniques that can provide an~     acceleration of functional recovery of these individuals .~      Thus , the establishment of evaluation protocols that provide quantitative data concerning~     the functional capacity is of utmost importance . From the electromyographic analysis , one~     can measure the electrical activity of muscle and identify abnormal patterns of response.~     For the identification of kinematic changes becomes useful equipment capable of recording~     the speed and angle of movement, as the accelerometer . Another evaluation method applicable~     to cases of herniated disc and back pain is the force platform to quantify the ground~     reaction force during the stance phase of the movement . Also , the quality of life should~     be taken into account as routinely observed psychological impairment involving issues~     related to vitality, emotional and social aspects , which can be identified through the~     questionnaire of quality of life ( SF -36 ) .~      With regard to physical therapy intervention , we seek to use resources to compose promising~     treatment program along with conventionalexercises. A novel therapy in the treatment of back~     pain is the whole body vibration , as it promotes increased range of muscle spindles via~     increasing the tonic vibration reflex and consequently improving the mechanism of~     involuntary muscle control . Thus , the association between an accurate assessment ,~     exercises and therapy vibratory seeks early rehabilitate individuals affected by back pain~     or herniated disc , delaying or even avoiding surgery .~   "
79646|NCT02014935|"~     The poor eating habits and sedentary lifestyle of young people can reflect on structural~     changes in adult life, leading to vascular brain diseases. The cerebrovascular accident~     (AVC) represents the second cause of death throughout the country. Presents rapid~     development of clinical signs, providing focal disorders or brain function. It is necessary~     to the knowledge and development of new treatment techniques that may minimize the sequelae~     caused by the AVC, which is a common disease and of great impact on public health,~     represents the main cause of adult neurological disability, affecting the basic functions of~     the limbs, motor control and balance, strength and mobility, which involves changes in daily~     life and low self-esteemIn addition to the high cost of treatment and in the long run.~      Thus, this study aims to analyze the response of low intensity laser on the prevention of~     pain and fatigue induced in rectus femoris, vastus of patients with sequelae of spasticity~     associated with effects on the laser promotes on muscle performance and muscle activity.~      It is believed that this study get positive results as regards the increase of time~     antecedent to muscular fatigue associated with the skeletal muscle performance, so that the~     normotonics muscles gain strength and overcome the resistance of hypertonic muscles. In this~     way, it is expected that after the application of low intensity Laser Therapy (LILT) occurs~     to the adequacy of spasticity, muscle function the gain that had provided the highest~     quality of physiotherapy care.~      It is known that treatment with the laser on the skeletal musculature, presents positive~     results and on the peak torque, by means of the skeletal muscle performance and consequently~     gain increase muscle performance (LEAL JUNIOR et al, 2010; ALMEIDA et al, 2011).~      Armed with this information you can infer that the low intensity laser therapy on the~     spastic muscle, would result in improving muscle performance, with an increase of~     pre-stressing, improving the functional capacity of individuals under the exercises imposed~     by physical therapy. In this way, the sessions will take more satisfactory results which~     jointly provided better quality of life for these patients.~   "
79647|NCT02014922|"~     Dry eye is a very common condition that most often affects women and the elderly, and can be~     caused when the eyes do not produce enough tears, or when the tears evaporate too quickly.~     Although there isn't a simple cure for dry eye, there are numerous products on the market~     that attempt to help relieve some of the discomfort caused by this condition. Some of these~     products include artificial tears, omega-3 supplements, and/or anti-inflammatory~     medications. The purpose of this study is to evaluate the performance of a combination of~     TheraTears® products, and to compare them with the product(s) you have been using.~   "
79655|NCT02014818|"~     To treat patients with stable coronary artery disease, elective percutaneous coronary~     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium~     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current~     standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be~     evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after~     stent placement, along with observation of changes over time in the target vessel. The~     relationships between OCT findings and the time course of platelet aggregation and between~     OCT findings and the occurrence of major cardio- cerebrovascular events will also be~     elucidated.~   "
79656|NCT02014805|"~     The purpose of this study is to determine whether postoperative conformal radiotherapy are~     effective in the treatment of Masaoka stage II-III B type thymoma.~   "
79657|NCT02014792|"~     Studies suggest that dietary omega-3 fatty acids influence the extent to which the time~     interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated~     with increased risk of sudden cardiac death (SCD). The purpose of this research is to~     investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid~     levels in patients who have recently commenced haemodialysis.~   "
79658|NCT02014779|"~     Objectives: This study will evaluate the efficacy of internet-based relapse prevention with~     therapist support, as compared to face-to-face therapy at an employee assistance program.~     The design is a two-armed randomized controlled design, and outcomes are measured in terms~     of changes in problematic alcohol use, as well as depression and quality of life.~      Method: Participants with problematic alcohol use who, after an initial evaluation~     consisting of five face-to-face sessions with a licensed psychologist where alcohol and~     collateral problems are extensively assessed, are recommended treatment for problematic~     alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet~     delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on~     alcohol use, depression and quality of life as well as information on user satisfaction will~     be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.~      Our hypothesis is that the internet-based program with therapist support and the~     face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).~   "
79659|NCT02014766|"~     We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide~     similar analgesia after shoulder surgery.~   "
79660|NCT02014753|"~     To treat patients with acute myocardial infarction, primary percutaneous coronary~     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium~     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current~     standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be~     evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months~     after stent placement, along with observation of changes over time in the target vessel. The~     relationships between OCT findings and the time course of platelet aggregation and between~     OCT findings and the occurrence of major cardio- cerebrovascular events will also be~     elucidated.~   "
79661|NCT02014740|"~     The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®),~     on the fat surrounding the heart.Excessive amount of the fat around the heart is common in~     people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an~     injectable prescription medicine that can improve blood sugar control in adults with type 2~     diabetes.~   "
79662|NCT02014727|"~     The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg~     dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults~     not previously exposed to the parasite P.falciparum and in healthy African adults exposed to~     the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of~     solicited and unsolicited events/reactions. The safety profile will include local and~     systemic reactions/events as well as the biological safety, based on a clinically~     significant change of the baseline value of the main biological criteria.~   "
79663|NCT02014714|"~     Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2%~     to 4% in the general population. The incidence was double on patients who had a diagnosis of~     OSA going for orthopedics surgery.~      Little literature composed mostly of case reports or small retrospective case-control~     studies exist examining the use of intrathecal opioids on outcomes in OSA patients is~     inconclusive. The primary objective of this study is to compare the post operative~     respiratory effect after single dose intrathecal morphine and intrathecal fentanyl on~     orthopedics patients who suspected or undiagnosed obstructive sleep apnea.~      Hypotheses~      Undiagnosed OSA patients who received intrathecal morphine are more likely to have~     respiratory events post-operatively.~   "
79664|NCT02014701|"~     The goal of this study will be to assess the incremental benefit of myocardial contrast~     echocardiography for the assessment of regional wall motion abnormalities and~     infarct-related artery in patients presenting with their first NSTEMI.~   "
79665|NCT02014688|"~     This study is being initiated to create a normal database including measures of optic nerve~     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg~     Spectralis OCT device.~   "
79666|NCT02014675|"~     This registry is designed to gather further evidence, in addition to the SD01 Master Study,~     for the safety and efficacy of the SD01 ICD lead.~   "
79667|NCT02014662|"~     An isolated bout of unaccustomed maximal eccentric exercise is associated with muscle force~     loss for 2-4 days, mild reversible muscle tenderness, and ultra-structural damage to the~     muscle fibers, elevation of muscle proteins in serum, and a detriment in range of motion.~     This single center, pilot study is designed to optimize conditions for the robust~     measurement of functional deficits after muscle damage and to identify markers of repair~     over 22 days to inform future intervention studies. The primary measure will be limb force~     (assessed electronically from the ergometer), previous studies have demonstrated that~     functional measures return fairly rapidly, usually between 2-4 days. Additionally, several~     biomarkers of muscle function will be measured over 22 days, as well as changes in protein~     synthesis in biopsy samples Deuterium-labelled water (D2O) will be consumed by all study~     participants from Day-3 through Day 22 to aid in quantifying newly synthesized proteins.~   "
79668|NCT02014649|"~     This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data~     of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also~     explore virology and efficacy endpoints.~   "
79669|NCT02014636|"~     This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects~     with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475~     followed by an expansion cohort to determine the maximum tolerated regimen and the~     recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the~     clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib~     and single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and~     tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of~     pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with~     single-agent pazopanib and single-agent MK 3475.~   "
79670|NCT02014623|"~     Allergic diseases represent a major health issue worldwide and epidemiological studies in~     Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy~     (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay~     treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief.~     Allergen immunotherapy offers the advantages of specific treatment with long lasting~     efficacy, and can modify the course of disease. However, use of this treatment is restricted~     by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes~     of allergen administration than the current conventional subcutaneous route (SCIT) have been~     investigated including the sublingual route (SLIT) and recently sublingual tablets for~     pollen allergy immunotherapy became available. The tablets are safe and easy to use and~     contain pollen extracts from 5 of the most common allergy-causing European grasses but~     include ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and~     south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not~     fully understood. The investigators propose conducting a longitudinal open label study to~     investigate the immunological changes that occur with the 5 grass pollen sublingual~     immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects.~     The investigators will investigate the induction of relevant T cell regulatory immune~     mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4.~     Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will~     be examined. This project will provide important fundamental knowledge on which to inform~     decisions for the greater application of this treatment for subjects with moderate and~     severe allergic rhinitis.~   "
79671|NCT02014610|"~     The complete blood count is a commonly performed blood test, and previous small studies have~     suggested that the counts of some types of white blood cell in the complete blood count may~     be related to the onset of cardiovascular diseases such as stroke and heart attack. This is~     of interest because this information may help to predict strokes or heart attacks and may~     guide new therapies which act on white blood cells to reduce the risk of cardiovascular~     disease.~      The hypothesis is that counts of particular types of white blood cell are associated with a~     range of cardiovascular diseases.~   "
79672|NCT02014597|"~     The purpose of this study is to determine if an optokinetic contrast detection device is~     sufficient to measure contrast sensitivity and to distinguish between patients with and~     without glaucoma.~   "
79673|NCT02014584|"~     Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase~     inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile~     dysfunction and loss of libido. This will be a multicenter, randomized, double-blind,~     placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on~     sexual function as well as subject satisfaction with hair growth and quality of life in men~     with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a~     Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment~     phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of~     open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted~     for any individuals with a change in erectile function at the end of treatment.~   "
79674|NCT02014571|"~     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the~     treatment of chronic hepatitis C virus (HCV) infection. The purpose of this study is to~     investigate the effects of GSK2878175, at different doses in men and women infected with~     chronic hepatitis C virus. The study will investigate how much of the drug gets into the~     blood stream and how long the body takes to get rid of it. The study will also investigate~     if GSK2878175 has any important side effects. The study will also measure what effect~     GSK2878175 has on the hepatitis C virus infection after taking the study medication for 2~     days. Approximately 44 people will take part in this study. Depending on the type of chronic~     hepatitis C infection a subject will be enrolled into 1 of 4 groups randomly. Each group~     will participate in one dosing session. One dosing session consists of GSK2878175 or a~     placebo (sugar pill) given once per day for 2 days.~      Group A, B, and C is made up of 8 participants per group. In each of these groups 6~     participants will receive GSK2878175 and 2 participants will receive placebo. Group D is~     made up of 20 participants. 15 participants will receive GSK2878175 and 5 participants will~     receive placebo. The treatment groups will be dosed in sequence. Group A will be the first~     to take the study medication, then Group B, and so on. The plan is to dose subjects in Group~     A with 10 mg, Group B with 30 mg, Group C with 60 mg, and Group D with 60 mg of GSK2878175~     or placebo. The next treatment group's actual dose will be decided after looking at the~     results from the previous group. The doses may therefore be higher or lower than planned~     depending on the previous group's results. The number of participants enrolled in the next~     group may also change depending on the results from the previous group.~   "
79675|NCT02014558|"~     The objective of this study is to assess the safety and tolerability, including the maximum~     tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid~     leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of~     ASP2215.~   "
79676|NCT02014545|"~     This is a randomized, double blind placebo controlled study to evaluate safety and efficacy~     of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy~     (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.~   "
79677|NCT02014532|"~     The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and~     root planing in patients with chronic periodontitis leads to host inflammatory response~     modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open~     new vistas in treatment of chronic periodontitis.~   "
79678|NCT02014519|"~     The purpose of this study is to perform a epidemiological survey of the adult population in~     Hungary to calculate the seroprevalence of pertussis.~   "
79679|NCT02014506|"~     Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of TBI,~     fludarabine, cyclophosphamide and antithymocyte globulin with TCRαβ-depleted graft from~     haploidentical family donors in treating children and adolescents with malignant or~     non-malignant diseases.~   "
79680|NCT02014493|"~     Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature~     respiratory center and having respiratory distress. CPAP requires intensive care monitoring~     and special qualified staff. Continuous positive pressure makes a constant noise around the~     child and can lead to an uncomfortable environment.The fixture of the binasal prongs can~     cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered~     important for the child.~      Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive~     care units.HFNC is considered to be easy to apply and a more comfortable respiratory support~     for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified~     air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from~     intensive respiratory support, to prevent respiratory distress and as a respiratory support~     after extubation.~      There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is~     to investigate the preterm infants respiratory effort by measuring electrical activity in~     diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a~     scoring system inspired by Silverman- Andersen retraction score. It is expected that~     measured electrical activity in the diaphragm, measured respiratory parameters combined with~     bedside observations provide applicable knowledge about preterm infants respiratory effort~     in transition from CPAP to HFNC.~   "
79681|NCT02014480|"~     This is a multicenter, randomized, double-blind, 3-way crossover study to evaluate the lung~     function response to UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.525 mcg, administered~     once-daily via a novel dry powder inhaler (NDPI) over 14 days in subjects with COPD.~      The study consisted of Run in Phase (5 to 7 days), Treatment Phase (made up of 3 treatment~     periods of 14 days each separated by 10 to 14 days Washout Period) and Follow-up Phase (7 to~     9 days after completion of final visit or premature discontinuation). Eligible subjects will~     be randomized to a sequence of UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.5/25 mcg such that~     all subjects will receive each treatment.~      Serial spirometry assessments will be conducted on Day 1 and Day 14 and trough spirometry~     will be conducted on Day 2 and Day 15 of each treatment period. On Day 1 and 14 of each~     treatment period vital signs will be assessed and adverse event (AE)s will be recorded~     throughout the total duration of the study (approximately 12 weeks).~   "
79682|NCT02014467|"~     This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12~     month treatment in Chinese postmenopausal women with osteoporosis at increased risk of~     fracture.~   "
79683|NCT02014454|"~     The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops~     in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm~     newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will~     receive propranolol eye drops treatment until retinal vascularization will be completed.~      Propranolol concentrations will be measured on dried blood spots during the first 3 days of~     treatment and at the steady state. Cardiovascular and respiratory parameters will be~     continuously monitored. Blood samplings checking metabolic, renal and liver functions will~     be performed periodically, as well as cardiac function, in order to verify the treatment~     safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the~     treatment, the ROP progression and the possible complications.~   "
79684|NCT02014441|"~     The primary objective was to estimate the proportion of participants with detectable~     talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time~     after administration of talimogene laherparepvec within the first 3 cycles.~   "
79685|NCT02014428|"~     To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the~     treatment of atrophic vaginitis.~   "
79686|NCT02014415|"~     The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis)~     in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic,~     under-recognized, and undiagnosed. In addition, the investigators believe that the genetic~     and environmental factors that play an important role in the development of alpha-1~     antitrypsin (AAT) liver disease, can be identified by comparing a cohort database of~     clinical disease information to linked biospecimen and DNA samples.~   "
79687|NCT02014402|"~     This purpose of this clinical trial is to study the safety and efficacy of Topical Thrombin~     (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft~     tissue, and spinal open surgical procedures. Approximately 180 subjects will be treated with~     either Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI® (60~     subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in~     which control of bleeding by standard surgical techniques is ineffective or impractical and~     requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate~     the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin~     JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.~   "
79688|NCT02014389|"~     Objective perimetry can better monitor visual field defects in retinal dystrophy and~     Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to~     short and long wavelength stimuli should be significantly lower compared to healthy~     participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.~   "
79689|NCT02014376|"~     The purpose of this study is to assess whether SD-101 cream (3% or 6%) is effective in~     treating the lesions in subjects with Simplex, Recessive Dystrophic, or Junctional~     Epidermolysis Bullosa.~   "
79690|NCT02014363|"~     To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline~     in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.~   "
79691|NCT02014350|"~     To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend~     Reverse Shoulder Stystem.~   "
79692|NCT02014337|"~     This is a study to assess the safety of the combination of mifepristone and eribulin in~     patients with metastatic or locally advanced unresectable breast or other specified solid~     tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin~     in patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer~     (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter~     trial with no control group. The study will be conducted at up to 11 sites, with up to 40~     evaluable patients~   "
79693|NCT02014324|"~     Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most~     frequent cause of cancer death. Accurate staging is important because it directs treatment~     and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two~     techniques have a complementary diagnostic range and the combined procedure is suited for~     assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is~     indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the~     combined procedure). Second, frequently only one or two, by imaging suspected lymph node~     stations, are sampled (ie. targeted approach).~      Objectives: main and secondary:~        1. Complete endosonographic (combined endobronchial and esophageal) staging using a single~          EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.~        2. Systematic mediastinal staging results in improved locoregional staging compared to~          PET-CT directed assessment of the mediastinum (ie targeted approach).~      Study population: Patients with potentially operable and resectable NSCLC are eligible if~     there is an indication for mediastinal nodal sampling. Patients have an indication for~     EBUS-TBNA.~      Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same~     session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET~     imaging and on subsequent ultrasound are sampled.~      Main study endpoint: The main study parameter is the sensitivity for locoregional disease~     (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in~     comparison with EBUS staging alone.~   "
79694|NCT02014311|"~     The aim of this study is to assess whether the clinical management of patients with recent~     acute-onset chest pain without acute coronary syndrome may be optimized by a combined~     coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic~     strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for~     invasive testing will be performed within 2 weeks after hospital discharge.~      The following main hypothesis will be tested:~      - Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in~     a safe and optimized, cost-effective invasive treatment strategy~   "
79695|NCT02014298|"~     BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel~     mature burn scars.~      OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn~     scars after NAFL-treatment.~      HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and~     functional appearance.~      METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are~     randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded~     evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar~     Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).~   "
79696|NCT02014285|"~     Examination of serial muscle ultrasounds and muscle sampling within the population of ICU~     patients who require mechanical ventilation for acute respiratory failure, will lead to the~     ability of investigators to link specific baseline comorbidities, drugs, or fluid~     administrations, to the onset and duration of architectural changes within muscle and~     correlate ultimately with muscle function. With this study, we will be better able to~     understand the relationships between the pattern of resolution of the muscle architectural~     abnormalities within the context of multiple other clinical abnormalities and therapies~     present and rendered to ICU patients.~   "
79697|NCT02014272|"~     This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual~     reference drugs in healthy volunteers.~   "
79698|NCT02014259|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of~     oral semaglutide in subjects with various degrees of impaired renal function compared to~     subjects with normal renal function.~   "
79699|NCT02014246|"~     Background:~      There are two basic types of movement disorders. Some cause excessive movement, some cause~     slowness or lack of movement. Some of these are caused by mutations in genes. On the other~     hand, dementia is a condition of declining mental abilities, especially memory. Dementia can~     occur at any age but becomes more frequent with age. Researchers want to study the genes of~     families with a history of movement disorders or dementia. They hope to find a genetic cause~     of these disorders. This can help them better understand and treat the diseases. This study~     will not be limited to a particular disorder, but will study all movement disorders or~     dementias in general. This study will perform genetic testing to identify the genetic causes~     of movement disorders and dementia. Today, genetic testing can be done to analyze multiple~     genes at the same time. This increases the chances of finding the genetic cause of movement~     disorders and dementias.~      Objectives:~      To learn more about movement disorders and dementia, their causes, and treatments.~      Eligibility:~      Adults and children with a movement disorder or dementia, and their family members.~      Healthy volunteers.~      Design:~      Participants will be screened with medical history and blood tests. Some will have physical~     exam.~      Participants will give a blood sample by a needle in the arm. This can be done at the~     clinic, by their own doctor, or at home. Alternatively, a saliva sample may be provided if a~     blood sample cannot be obtained.~      Participants can opt to send an extra blood sample to a repository for future study. Genetic~     test will be done on these samples. The samples will be coded. The key to the code will~     remain at NIA. Only NIA investigators will have access to the code key. Participants can~     request to receive results of the tests.~      Participation is generally a single visit. Participants may be called back for extra~   "
79700|NCT02014233|"~     Nerves are the rate limiting factor that control muscle function. However, it is unknown if~     a nutritional supplement can change the nerve-muscle interaction, and therefore alter human~     performance. This study will be the first to examine the effects of omega-3 supplementation~     on neuromuscular function in trained individuals.~   "
79701|NCT02014220|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of consuming potato chips from different~     cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the~     chips produced from various potato cultivars will differ in their effect on blood glucose,~     satiety and food intake.~   "
79702|NCT02014207|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of altering commercial blanching and~     cooling times during manufacture of frozen fries produced by the on blood glucose, satiety~     and appetite. It hypothesized that the processing regime predetermines the physiologic~     responses to ingested product and therefore it is possible to produce healthier product~     lines of potato fries.~   "
79717|NCT02014012|"~     Arterial stiffness has been suggested as an independent risk factor for the development of~     coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established~     index to quantify arterial stiffness. Therefore, we try to investigate the correlation~     between PWV values and cardiovascular complications like stroke, acute renal failure, or~     perioperative myocardial infarction after cardiac surgery.~   "
79703|NCT02014194|"~     Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no~     significant improvement is reached in about 30% to 40% of patients. Thus, the development of~     new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in~     capturing the attention of an individual compared to a neutral stimulus - has been~     extensively studied. Already training attentional bias modification has been shown effective~     in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate~     knowledge on attentional bias in individuals with OCD through the use of a standardized~     protocol developed for OCD; 2 - available to the scientific community the first specific~     paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a~     training protocol for reversing attentional bias in individuals with OCD.~   "
79704|NCT02014181|"~     Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation~     and oxidative stress - a byproduct of daily stress the human body faces everyday and~     especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a~     mutation in sodium and chloride transport channels that results in pancreatic insufficiency,~     chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic~     inflammation and oxidative stress are a part of the chronic exacerbations that are a part of~     cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and~     antioxidative properties can help dampen these stressors on the CF lung and potentially~     result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved~     well-being.~   "
79705|NCT02014168|"~     This is a single blinded placebo controlled phase I study, to assess the safety and~     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the~     Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18~     and over.~   "
79706|NCT02014155|"~     Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ®~     through an inspiratory muscle training (IMT) that allows training of the inspiratory~     muscles, the chief of these being the diaphragm which is which objectified the improvement~     of its function . To monitor the action of the respiratory muscles can be used several tools~     such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory~     muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic~     activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded,~     composed of 45 individuals obtained by random convenience and divided into three groups,~     COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR -~     Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained~     Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek~     to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle~     strength, lung volumes and breathing patterns before and after a period of eight weeks of~     TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and~     TGNR only at baseline.~      Hypothesis:~        1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP)~          in COPD patients regardless of whether they are enrolled in a program of pulmonary~          rehabilitation (PR).~        2. TMI alters the breathing pattern in COPD patients regardless of whether they were~          entered into a PR program.~        3. Patients with COPD who do not participate in a PR program have higher handgrip strength~          compared to patients who did not participate in a PR program.~        4. There is decreased activity of the sternocleidomastoid muscle due to increased activity~          in the diaphragmatic muscle fibers after a period of TMI.~        5. TMI in COPD patients participating in a program RP produces greater increase in MIP,~          the handgrip strength, improves breathing pattern and a greater reduction in the~          activity of the SCM muscle and diaphragm than in those who did not participate in a~          program RP.~        6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood~          pressure and increased oxygen saturation at the end of the TMI.~        7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the~          training period.~   "
79707|NCT02014142|"~     Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS~     placement on efficacy will also be examined.~   "
79708|NCT02014129|"~     The main purpose of this study is to evaluate safety and side effects of LY2835219 in~     Japanese participants with advanced cancer.~   "
79709|NCT02014116|"~     The main purpose of this study is to see how safe the investigational drug known as~     LY3009120 is and whether it will work to help people with advanced cancer or cancer that has~     spread to other parts of the body.~   "
79710|NCT02014103|"~     Conduct a retrospective study to evaluate the impact of generic conversion in adult~     transplant recipients on post transplant outcomes one year prior to conversion to one year~     post conversion. Variables for analysis will include but not limited to incidence of~     rejection, hospital admission, changes in renal function, changes in transplanted organ~     function. All tacrolimus levels and dose changes during this period will be collected and~     compared. Additional pharmacokinetic modeling of this data will be performed for comparison.~      The prospective study will compare othe relative bioavailability and steady-state~     pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study~     including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.~   "
79711|NCT02014090|"~     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by~     percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External~     Counterpulsation (EECP) with regard to coronary collateral growth.~   "
79712|NCT02014077|"~     This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to~     reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is~     that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less~     complications and shorter hospital stay.~   "
79713|NCT02014064|"~     Methamphetamine (MA) abuse is a national public health concern. People who are dependent on~     MA have problems with mental functions (e.g., learning, remembering, focusing attention,~     solving problems). Such problems can interfere with their treatment for MA abuse, and~     thereby may promote continued drug use. While the effects of MA have been studied in rodents~     and non-human primates, its effects on the human brain have not been well characterized.~      This is a study of nontreatment seeking individuals who use MA compared to individuals who~     do not use MA(control participants). The study has three goals: 1. it aims to identify the~     brain regions and pathways that may contribute to the problems of MA abusers in performing~     mental tasks; 2. it will serve as a double-blind, placebocontrolled,within-subjects study to~     determine the safety and tolerability, and positive effects of MA in MA-abusing volunteers~     treated with atomoxetine or placebo; 3. It aims to compare the brain activity as measured by~     structuraland functional magnetic resonance imaging (fMRI). These are noninvasive brain~     imaging procedures, that will be used to study brain function while control and MA using~     participants take atomoxetine or placebo and perform tests of memory and concentration.~      MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the~     participants to proceed with the study they will participate in two inpatient phases of the~     study that will occur in the UCLA research setting, the General Clinical Research Center.~     The first inpatient stay will be 15 days, and the second will be a 9 days stay that includes~     drug administration and assessments. There will be at least a two week interval between~     inpatient phases. During the inpatient phases participants will receive alternating study~     drugs; atomoxetine or placebo and four sessions of IV MA administration or placebo.~      The study schedule for control participants will include a 1-day outpatient screening and~     two phases of outpatient administration of atomoxotime or placebo with a two week study drug~     free interval between the phases. Four to five of the outpatient study visits will involve~     cognitive tests and brain imaging studies.~   "
79714|NCT02014051|"~     The purpose of this study is to investigate tolerability when SyB C-1101 is orally~     administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or~     refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum~     tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics~     and antitumor effects will also be investigated.~   "
79719|NCT02013986|"~     Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal~     cortical inhibition by etomidate has received much attention. However wether the circadian~     rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is~     not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical~     outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is~     that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children~     for 24-48 hours，and this does not make clinical outcomes worse postoperatively.~   "
79720|NCT02013973|"~     The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro~     fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone~     ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI~     (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than~     does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12~     oocytes during COH.~   "
79721|NCT02013960|"~     1. Comparison between the duration of time from the beginning of cervical preparation~          until abortion, between sublingual misoprostol and the combination of sublingual~          misoprostol with laminaria for second trimester medical termination of pregnancy (TOP).~        2. Comparison between the adverse event rate following Sublingual misoprostol only vs.~          Sublingual misoprostol and laminaria given for pregnancy termination.~        3. Comparison between the levels of satisfaction rate of women who underwent pregnancy~          termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.~   "
79722|NCT02013947|"~     The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia,~     dyslipidemia and hypertension) and it is a risk factor for the development of type 2~     diabetes and atherosclerotic cardiovascular disease. There are several definitions for the~     metabolic syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood~     Institution)and IDF (International Diabetes Federation)2009 criteria are frequently used to~     comparing data from studies. Prevention or reduction of obesity and lifestyle modification~     with physical activity is the main therapeutic goal in patients with metabolic syndrome.~     Recent studies have shown that exercise in moderate altitude or in moderate hypoxia improved~     glycemic parameters. The influence of training in moderate altitude on circulating~     metabolites and hormones in terms of substrate utilization is unclear. The adiponectin seems~     to play an important role in the homeostasis of adipose tissue and in the pathogenesis of~     the metabolic syndrome and physical activity seems to have a positive effect on adiponectin~     concentrations. In this study with randomized controlled pretest-posttest-design we want to~     investigate the effects of physical activity in moderate hypoxia on biomarkers of metabolic~     syndrome.~   "
79723|NCT02013934|"~     The objective of this study is to assess the benefit and tolerability of a probiotic product~     in subjects with increased susceptibility to common cold.~   "
79724|NCT02013921|"~     Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in~     different cancer types.~      It therefore seems necessary to assess spontaneous Physical Activity in order to integrate~     it to the overall calculation of physical activity in clinical practice.~      To assess the AP, two types of methods are validated : the subjective method using a~     questionnaries and objective method using a pedometer , accelerometer or measures~     calorimetry .~      Subjective method shows , good acceptability by patients and low cost but can sometimes lead~     to poor estimation of the level of activity.~      Objective methods obviously increase the accuracy of assessments but are more difficult to~     use for epidemiological studies , less accepted by the patient and more expensive.~      In this study the investigators will measure the spontaneous Daily Physical Activity by both~     methods andd evaluate the correclation.~   "
79725|NCT02013908|"~     Acupuncture is widely used for managing acute and chronic pain conditions. In the context of~     an emergency department (ED), patients often present with non-emergent acute pain symptoms.~     This may result in a delayed triage process and inefficient emergent management. An~     integrative patient-care approach in emergency departments has been explored that may~     improve patient satisfaction and promote efficient use of healthcare resources for~     non-emergent patients in the ED. This implies there is a potential role for acupuncture in~     such contexts. The aim of this pilot study is to assess the effectiveness and safety of~     acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal~     pain and primary headaches in an ED setting.~      Hypotheses of this study are as follows:~        1. A single session of add-on acupuncture, with standard ED management, can reduce pain~          levels in non-emergent acute pain, compared to standard ED management alone.~        2. A single session of add-on acupuncture to standard ED management can reduce additional~          consumption of healthcare resources for management of non-emergent acute pain, compared~          to standard ED management alone.~      This study aimed to include 40 participants, 20 in the acupuncture plus standard ED~     management group and 20 in the standard ED management alone group.~   "
79726|NCT02013895|"~     Preoperative evaluation of future remnant liver function is critical for patients undergoing~     hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening~     postoperative hepatic failure, and its underestimation can lead to a lost opportunity for~     potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has~     been estimated preoperatively using computed tomography (CT) volumetry. CT can provide~     precise anatomical information, and the remnant liver volume, measured by CT volumetry, has~     been reported to be an effective predictor of hepatic dysfunction after hepatectomy.~     However, the indirect estimation of liver function by CT volumetry is reliable only when the~     function is assumed to be homogenous over the whole liver.~   "
79727|NCT02013882|"~     We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of~     O2:N2O 1:1 L/min with desfluraene 12%.~      The objective of this study is to identify time to achieve alveolar concentration of~     desflurane at1, 2, 3, 4, 5 and 6%.~   "
79728|NCT02013869|"~     To study the Flow-I breathing circle during low flow general anaesthesia, whether this~     non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar~     concentration) and lower consumption of inhaled agent~   "
80294|NCT02006446|"~     In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need~     to be improved in order to increase the success of assisted reproduction treatments.~      The aim of this study is to determine whether the presence of sperm head vacuoles is~     associated with sperm DNA alterations.~   "
79729|NCT02013856|"~     Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease~     (CVD). The protective effect may be ascribed to compounds contained within these foods,~     called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of~     flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine.~     There is evidence to suggest that ingestion of flavanol rich foods and beverages~     beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to~     determine the acute and chronic effects of apple derived flavanols on some risk markers for~     CVD.~   "
79730|NCT02013843|"~     In the present study the effect of a community-based treatment of overweight and obese~     children is analyzed. The treatment-method is based on the principals and the method used in~     the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated~     by the change in body mass index standard deviation score, change in blood pressure standard~     deviation score, quality of life and concentration of fasting blood lipids and glucose~     during one year of treatment.~   "
79731|NCT02013830|"~     This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus~     intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The~     anticipated time on study treatment is 3-12 months.~   "
79732|NCT02013817|"~     This study will evaluate the efficacy and safety of intense combination treatment including~     MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients~     with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is~     2.5 years.~   "
79733|NCT02013804|"~     This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680~     (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor~     activity in adult subjects with solid tumors.~   "
79734|NCT02013791|"~     This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in~     patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be~     studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will~     participate in Stage 2 of this study.~   "
79735|NCT02013778|"~     Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of~     the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial~     chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3~     design will be utilized. Primary Phase II: To evaluate the complete response rate in a~     cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.~   "
79736|NCT02013765|"~     This study will evaluate the efficacy and safety of intravenous Herceptin in patients with~     metastatic urothelial cancer with disease progression during platinum-based chemotherapy.~     The anticipated time on study treatment is until disease progression.~   "
79737|NCT02013752|"~     The purpose of this study is to determine whether a modified perineum protection device can~     reduce tearing during delivery.~   "
79738|NCT02013739|"~     The purpose of this study is to describe insulin resistance in a general chronic heart~     failure population, in combination with muscle strength, body composition and cardiac~     function.~      It is assumed that insulin resistance is increased in CHF patient, and that this is related~     to decreased muscle strength and decreased lean tissue mass.~   "
79739|NCT02013726|"~     Primary:~      In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI~     (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in~     detecting breast cancer than breast tomosynthesis.~      Secondary:~        1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly~          classifying subjects without breast cancer will be non-inferior to breast~          tomosynthesis.~        2. In women with heterogeneous or dense breast tissue, the area under the receiver~          operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast~          tomosynthesis.~        3. Combining the use of MBI and breast tomosynthesis will provide performance superior to~          either technology alone, as manifest by a superior ROC curve area.~   "
79740|NCT02013713|"~     The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes~     suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at~     increased cardiovascular risk.~      The frequency of familial hypercholesterolemia in cardiologic is little studied and remains~     unknown, and there is little data on the profile of patients, diagnostic methods and~     management.~      Main objectives:~        -  Establish a monitoring patients with hypercholesterolemia Family cardiology in France~        -  Characterize the Family hypercholesterolemia in cardiology, including assessing the~          frequency of the most severe forms, which are at higher cardiovascular risk.~   "
79741|NCT02013700|"~     This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in~     followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot~     phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem~     cells and in the randomized phase subjects will receive either allogenic mesenchymal stem~     cells or matched placebo.~   "
79742|NCT02013687|"~     This study is a Phase 1, dose escalation, first-in-human study designed primarily to~     evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel~     adjuvant~   "
79743|NCT02013674|"~     Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI~     scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase~     II study intended to gain additional safety and efficacy assessments among two dose levels~     previously studied in a phase I setting.~   "
79744|NCT02013661|"~     The aims of this study were to evaluate and compare tissue erythema, edema and knot~     loosening among four types of suture one week after periodontal surgery.~   "
79745|NCT02013648|"~     This is a randomized phase III open-label, multicenter trial evaluating standard induction~     therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose~     cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML~   "
79999|NCT02010307|"~     aggressive periodontitis is an inflammatory disease which damage the teeth supporting~     structures mostly in young patients. and has genetic basis.~      a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this~     disease, and found to damage leukocytes by using a specific leukotoxin.~      in the research the investigators are aiming to find molecular and immunological basis to~     aggressive periodontitis.~   "
79746|NCT02013635|"~     Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence~     of 3 to 4 per million people. It occurs generally in young patients (mean age of occurrence~     = 40 years) and principally in young females (75%) generally in pregnancy or oral~     contraceptive use situations.~      The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more~     than 30 days). The clinical presentation is highly variable and includes patients with only~     a mild headache, others with focal neurological deficits and a few with a dramatic syndrome~     and a coma. Moreover the evolution can be very different with unpredictable outcome: more~     often it is favorable with a low mortality rate, but in some cases it can be a worse course.~     The aim of this study is to evaluate the correlation of some biological markers: thrombin~     generation test and D-Dimers (marker of fibrin generation and degradation) with the type of~     onset or the wide spectrum of clinical presentations or the different modes of evolution.~      All patients over 16 years ago may be included in the program when CVT diagnosis is proved~     by magnetic resonance angiography (MRA). For each included patient, there are four blood~     assays: the first just at the time of diagnosis and before the beginning of treatment, the~     second before the beginning of the oral anticoagulant treatment. The third assay is done in~     the third month at the time of a MRA. The last assay is made one month after the end of the~     anticoagulant treatment or in 12th month after the beginning of the disease if the treatment~     goes on.~      For each sample, the investigators perform a thrombin generation test and a D-Dimers~     measurement.~   "
79747|NCT02013622|"~     The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole~     monotherapy in the improvement of early-episode schizophrenia through the assessment of~     social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as~     episodes occurring ≤ 5 years after the onset of the first episode.~   "
79748|NCT02013609|"~     To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment~     in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective~     serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI)~     response in a school or work environment.~   "
79749|NCT02013596|"~     The purpose of this study is to compare the effect of TEAS pretreatment and treatment on~     hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing~     laparoscopic surgeries.~   "
79750|NCT02013583|"~     The purpose of this protocol is to create a registry for patients diagnosed with Glucose~     Transporter Type 1 Deficiency (G1D), or patients experiencing symptoms consistent with G1D~     but not yet diagnosed, to enter medical information for physicians and other health~     researchers to analyze to increase the understanding of G1D and any sub-diagnoses.~   "
79751|NCT02013570|"~     The purpose of the present study is the clinical assessment of the efficacy of preincisional~     peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children~     undergoing adenotonsillectomy.~   "
79752|NCT02013557|"~     Purpose: The purpose of this study is to see whether a text-message reminder system will~     increase the number of women who complete their diabetes screening after delivery.~      Study Design: Prospective randomized control trial~      Hypothesis: Gestational diabetics will be significantly more likely to follow up with their~     postpartum screening for diabetes if they receive text-message reminders to set up their lab~     appointment compared to those who receive usual care.~   "
79753|NCT02013544|"~     The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on~     symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects~     exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.~   "
79754|NCT02013531|"~     The purpose of this study is to investigate the efficacy and safety of flexibly dosed~     adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety~     symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor~     (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.~   "
79755|NCT02013518|"~     A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's~     disease, will be recruited from three hospitals in Norway.~      The intervention is based on a standardized manual, and consists of 11 weekly one-hour~     sessions, which are organized into six thematic modules.~      The content of each session is specified by a treatment manual, which additionally consists~     of worksheets, suggestions for homework in between sessions and letters to the caregivers~     (the German manual: Werheid & Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner &~     Tonga, not published). The treatment will be conducted by experienced health staff (nurses,~     psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge~     about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the~     manual before study inception, participate in a two-day training seminar and will regularly~     be supervised.~      The control condition will be offered treatment as usual at the participating the memory~     clinics.~      The hypothesis is that the participants in the intervention group will report less~     depression and increased self efficacy as compared with the control group.~      We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to~     examine the feasibility of the study protocol and do want to include these patients in the~     study population.~   "
79756|NCT02013505|"~     The investigators hypothesised that a video based patient education will help patients~     understand the process of colon cleansing prior to a colonoscopy procedure and hence will~     result in clean colons that will may help physician perform a better quality examination.~   "
79757|NCT02013492|"~     This pilot trial studies propranolol hydrochloride in treating patients with locally~     recurrent or metastatic solid tumors that cannot be removed by surgery. Propranolol~     hydrochloride may slow the growth of tumor cells by blocking the use of hormones by the~     tumor cells.~   "
79758|NCT02013479|"~     Our aim is to investigate if selenium supplementation versus placebo adjuvant to the~     standard treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will~     lead to improved thyroid specific quality of life, and reduced autoimmune activity. The~     trial will include 472 participants (2 X 236) from four clinical trial sites.~   "
79759|NCT02013466|"~     In this study healthy older adults are requested to consume 4 different high-protein~     nutritional supplements. Each subject will visit the site 4 times and at every visit they~     will consume 1 of the 4 products after which a series of blood samples will be taken. The~     blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours~     after consumption.~   "
79761|NCT02013427|"~     This study is designed to examine brain properties for placebo response in chronic back pain~     patients. The investigators have preliminary data indicating that, in blinded clinical trial~     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can~     be subdivided into placebo responders and non-responders, and these differences are~     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have~     clinical utility and that its properties can be studied by human brain imaging techniques.~     In Phase I of the study, the investigators seek to identify brain imaging parameters that~     predict the propensity for the placebo response in an independent CBP cohort. In Phase II,~     the investigators will evaluate the interaction between placebo response and medication~     treatment in individuals stratified as placebo responders versus non-responders. This~     research is designed to critically assess the neurobiology of placebo analgesia for chronic~     pain in a partially-blind clinical trial.~   "
79762|NCT02013414|"~     The objective of the proposed study is to evaluate a new, molecular image directed,~     three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy~     uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D)~     ultrasound images and has sampling errors thus some cancers can be missed from the standard~     2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to~     obtain three-dimensional (3D) images of the prostate from a commercially available~     ultrasound scanner. The clinician can use the 3D images to guide biopsy, record the core~     location of the biopsy sites, and perform re-biopsy to the same sites in a patient follow-up~     examination. This system can also use images from magnetic resonance imaging (MRI) or~     positron emission tomography (PET) and then fuse PET or MR images with 3D ultrasound images~     to guide the needle to a suspicious tumor target as seen on MRI or PET. We think that this~     fusion targeted biopsy technology will help to improve the accuracy of the current~     systematic biopsy approach for prostate cancer detection.~   "
79763|NCT02013401|"~     The central aim of this study is to assess mother-infant communication via behavioral,~     physiological, and affective indices under conditions where distal stressors may not be~     directly detectable by the infant.~   "
79764|NCT02013388|"~     A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of~     N91115.~   "
79765|NCT02013375|"~     Related donor stem cell transplantation using the alemtuzumab/ TBI platform has been shown~     to be a safe strategy to cure severe sickle cell disease. However, due to a lack of suitable~     donors, many patients cannot benefit from this strategy. Alternative donor sources are~     desperately needed to fill this gap. Nearly all patients will have a haploidentical family~     member who would be able to donate. The use of post transplantation cyclophosphamide has~     greatly improved the outcome of haploidentical stem cell transplantation. The investigators~     propose to combine this with alemtuzumab/TBI conditioning.~   "
79766|NCT02013362|"~     Phase I portion:~      To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and~     folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to~     determine the recommended dosage. Also, to evaluate pharmacokinetics.~      Phase II portion:~      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen~     determined in the phase I portion. The primary efficacy endpoint shall be objective response~     rate (ORR).~   "
79767|NCT02013349|"~     To evaluate the long-term safety and performance of the DESolve Novolimus Eluting~     Bioresorbable Coronary Scaffold System~   "
79768|NCT02013336|"~     This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The~     goal is to find the highest dose of MM-398 that can be given safely when it is used together~     with the chemotherapy drug Cyclophosphamide.~   "
79769|NCT02013323|"~     The present clinical trial was designed to investigate the clinical and microbiological~     effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and~     root planing (SRP) in the treatment of chronic periodontitis (CP)~   "
79770|NCT02013310|"~     This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in~     subjects with Age-Associated Memory Impairment (AAMI)~   "
79771|NCT02013297|"~     The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic~     radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.~   "
79772|NCT02013284|"~     The purpose of this study is to determine a relationship between a person's flora/bacteria~     in their gut (the intestinal microbiome) and their risk of cardiovascular disease.~     Investigators will look at inflammatory markers in the blood and also look at the genome of~     the bacteria in the gut.~   "
79773|NCT02013271|"~     To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long~     TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA~   "
79774|NCT02013258|"~     Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of~     oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of~     this study is to determine if oxytocin (OT) administration will improve some of the aspects~     of Prader-Willi syndrome that are particularly troublesome for children and their families~     (the insatiable appetite and social behaviors).~      The research questions are:~        1. Does intranasal oxytocin cause any side effects in children with PWS?~        2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?~   "
79775|NCT02013245|"~     The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential~     substitute for BCG vaccination.BCG vaccination has indeed demonstrated its major limitation~     in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight~     against the current world epidemics in tuberculosis and resistance to anti-TB drugs.~   "
79776|NCT02013232|"~     Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents~     and atypical antipsychotics such as risperidone. Recent studies have suggested that~     aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics.~     Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with~     aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with~     risperidone.~   "
80000|NCT02010294|"~     The main objective of the study is to characterize the virulence factors of SGA and identify~     immunological and / or genetic factors predisposing to infections in children hospitalized~     with invasive GAS infection.~   "
79777|NCT02013219|"~     This open-label, multicenter study will assess the safety, tolerability, and~     pharmacokinetics of intravenous (IV) dosing of MPDL3280A (Atezolizumab) in combination with~     oral erlotinib or alectinib in participants with non-small cell lung cancer (NSCLC).~      This study has two stages. In the erlotinib group, the combination treatment will be given~     to participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor~     (TKI)-treatment-naive, advanced (non-resectable) NSCLC in a safety-evaluation stage and to~     participants with previously untreated, EGFR mutation-positive, advanced NSCLC in an~     expansion stage (Stage 2). In the alectinib group, for both the safety-evaluation and~     expansion stages (Stages 1 and 2), the combination will be given to treatment-naive~     participants with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.~      In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) once daily~     (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive~     days during Cycle 1 and for 21-day cycles thereafter. The starting dose of atezolizumab will~     be 1200 mg, administered every 3 weeks (q3W) starting on Day 8 of Cycle 1. If the starting~     regimen for a combination treatment is not tolerated, alternative doses and/or schedules of~     erlotinib and atezolizumab or alectinib and atezolizumab may be tested to determine~     potential recommended phase 2 dose (RP2D) for that combination treatment. In Stage 2, a~     potential RP2D and schedule for each combination treatment will be investigated in an~     expansion cohort.~      For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the~     treating investigator. Study treatment will be discontinued in participants who experience~     disease progression or unacceptable toxicity, are not compliant with the study protocol, or,~     in their opinion or in the opinion of the investigator, are not benefiting from study~     treatment. However, in the absence of unacceptable toxicity, participants with second-line~     or greater NSCLC who are still receiving atezolizumab at the time of radiographic disease~     progression may be permitted to continue study treatment. Time on study is expected to be~     approximately 15 months.~   "
79778|NCT02013206|"~     This study will evaluate the efficacy and safety of Tarceva in two groups of patients with~     non-small cell lung cancer who have not been pre-treated with chemotherapy. One group,~     consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other~     group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a~     maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.~   "
79779|NCT02013193|"~     The primary objective of this study is to prove the superior performance of the Ranger™~     paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions~     when compared to non-coated balloons at six months post-procedure when comparing Late Lumen~     Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by~     angiography at six months follow-up after treatment of the femoropopliteal artery with~     Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment~     with uncoated PTA balloon control devices.~   "
79780|NCT02013180|"~     Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the~     prostate cancer, its specivity is not sufficient. Several PSA variations were defined in~     order to increase the specivity of the test, but they aren't much more effective than the~     PSA alone for detection of disease.~      In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat~     cancer disease.~      In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA),~     zinc/PSA, levels for early detection of the prostate cancer.~   "
79781|NCT02013167|"~     This study seeks adult subjects with Relapsed/Refractory (R/R) B-precursor ALL. This is a~     phase 3 randomized, open label study designed to evaluate the efficacy of blinatumomab~     versus investigator choice of SOC chemotherapy. Adult subjects with R/R B-precursor ALL will~     be randomized in a 2:1 ratio to receive blinatumomab or treatment with investigator choice~     of 1 of 4 protocol defined SOC chemotherapy regimens. Primary Endpoint is Overall Survival.~   "
79782|NCT02013154|"~     A study to evaluate the safety and tolerability of DKN-01 in combination with weekly~     paclitaxel in participants with refractory/recurrent esophageal, gastro-esophageal junction~     and gastric cancer.~   "
79783|NCT02013141|"~     This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants,~     children, and adolescents will receive a single 10 mg/kg dose of telavancin infused~     intravenously (IV) over 60 minutes~   "
79784|NCT02013128|"~     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in~     combination with Ibrutinib in patients with advanced hematologic malignancies.~   "
79785|NCT02013115|"~     Infants showing high local pulmonary inflammation diagnosted by respiratory distress~     syndrome usually need the second or more pulmonary surfactant and is easier to developing to~     Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome,~     Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is~     Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of~     Brochopulmonary dysplasia.~   "
79786|NCT02013102|"~     The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment~     of Myelodysplastic Syndrome.~   "
79787|NCT02013089|"~     Hypothesis: Different patients have different biomarkers, if doctors know about the~     biomarkers of patients; they may be able to prescribe a regimen that is better suited to the~     patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and~     Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if~     the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer~     who had failed from all standard and available regimens.~   "
79788|NCT02013076|"~     The aim of the prospective cohort study is to: (1) document the magnitude of response to~     oral corticosteroids administered to children presenting to the emergency department with~     moderate or severe asthma and (2) quantify clinically available potential determinants of~     the response to corticosteroids, such as age, gender, triggers of the index exacerbation,~     environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.~   "
79789|NCT02013063|"~     A small proportion of patients with lung cancer present with a solitary pulmonary nodule~     (SPN). This is an important group of patients because if it is lung cancer, presentation as~     a SPN represents early disease, which following surgery has a high 5 year survival rate.~     However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical~     guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give~     more information about the SPN and may indicate if it is likely to be lung cancer. However~     in many cases it does not and current practice is to monitor the SPN with a series of CT~     scans over 2 years to look for changes or growth which may/ but not always indicate lung~     cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This~     is both expensive for the National Health Service (NHS) and worrying for the patient in~     terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.~      This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast~     Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN~     and the investigators will look to see if information from either scan or combined~     information from both scans may be better in the diagnosis of early stage lung cancer. The~     investigators will also undertake a review of previous studies that have used these scans~     and use data from both the review and the trial to look at the cost effectiveness of using~     DCE-CT in the diagnosis of SPN.~      The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires~     a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or~     within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take~     place to normal NHS care, however we will collect clinical and outcome data over the next~     two years.~      The study is coordinated by Southampton University clinical trials unit. Recruitment between~     January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are~     expected by the end of 2018.~      The study is funded by the NIHR-HTA~   "
79791|NCT02013037|"~     All individuals who receive a heart transplant are at risk for developing antibody-mediated~     rejection (AMR). An antibody is a protein produced by the body's immune system when it~     detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an~     antigen. In antibody mediated rejection, antibodies will attack the transplanted heart,~     causing injury to the heart. The purpose of this investigation is to determine if a study~     drug, called Eculizumab (Soliris), prevents antibody-mediated rejection in patients with~     high antibody production and prolongs long-term cardiac transplant survival.~   "
79792|NCT02013024|"~     Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to~     slow freezing.~   "
79793|NCT02013011|"~     This study is to evaluate effects of recruitment maneuver in patients undergoing robotic~     assisted radical prostatectomy.~   "
79794|NCT02012998|"~     To evaluate the immune response to Hepatitis B virus in children who have been primed with~     HEXAVAC or INFANRIX HEXA 10 years ago.~   "
79795|NCT02012985|"~     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering~     urinary oxalate levels in patients with primary hyperoxaluria.~   "
79796|NCT02012972|"~     For national antiretroviral therapy (ART) programs, the most important health system goals~     in reducing morbidity and mortality among HIV-infection patients are to initiate treatment~     as early as eligibility criteria allow and to achieve the highest possible long-term~     retention of patients on ART. In South Africa, cohort data have consistently found high~     attrition among ART patients, with the combined cumulative outcomes of death and loss to~     follow up averaging 25-40% over the first five years after ART initiation. Like many other~     middle income countries, South Africa also faces very high rates of non-communicable~     diseases (NCDs) and NCD risks. Despite this, there are virtually no studies looking at~     interactions between ART and NCDs, and none that have considered the effect of NCDs and NCD~     risk factors on achieving the second health system goal mentioned above: long term retention~     on ART.~      The main RapIT study focuses on rapid initiation of ART, with short-term (6-month) attrition~     from treatment and viral suppression as the primary outcomes. In this supplemental study, we~     will evaluate the role of NCDs and NCD risk factors on long-term retention on ART, with~     outcomes including mortality, loss to follow up, viral suppression and immunologic~     improvement, and physical functioning, ability to perform normal daily activities, and~     economic productivity among patients already on ART. The study will enroll up to 400 adult~     patients already on ART for ≥ 12 months at the RapIT study site. At enrollment, consented~     subjects will be screened for elevated levels of several NCD risk factors including body~     mass index; glucose using HbA1c levels; blood pressure and cholesterol; as well as signs of~     abnormalities in hepatic, renal, and lung function. A medical history will be taken, and a~     questionnaire will gather information about chronic pain, alcohol use, smoking, physical~     functioning, ability to perform normal daily activities, and economic productivity. Referral~     for further NCD diagnosis and care will be offered as needed. Existing electronic medical~     records will be accessed to obtain retrospective data since ART initiation and to follow~     subjects prospectively for up to 24 months after the enrollment screening is completed. Six~     months after enrollment, subjects with NCDs or at high risk of NCDs will be re-screened at a~     routine ART medication pickup visit to assess uptake of referral and whether risks,~     conditions, or outcomes have changed. The study will help identify reasons for poor outcomes~     on ART and point to interventions that will help achieve the overall goals of the national~     ART program.~   "
79797|NCT02012959|"~     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases~     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic~     or hypervolemic hyponatremia.~   "
79798|NCT02012946|"~     This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing~     major non cardiac surgery, during and after the continuous infusion of levosimendan or~     dobutamine.~   "
79799|NCT02012933|"~     Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the~     nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many~     patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM)~     is an inherited disorder with similar affects and symptoms.~      3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some~     subjects with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively~     few side effects.~   "
79800|NCT02012920|"~     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics~     and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with~     castration-resistant prostate cancer (CRPC).~   "
79801|NCT02012894|"~     Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to~     laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated~     the relationship between LSG and GER the majority reported only changes in symptoms and~     manometric data, while assessment of GER using 24-hour pH monitoring is lacking.~      The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.~   "
79802|NCT02012881|"~     The purpose of this study is to determine the effect of a four months school-based physical~     activity intervention on cognition, academic achievement, physical activity and aerobic~     fitness in 12-15 year old adolescents.~   "
79803|NCT02012868|"~     Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients~     undergoing bariatric surgery.~      Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of~     them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However~     these studies are biased by a huge number of drop outs. The drop out rate in the studies are~     around 60 percent.~      The Investigators state that the prevalence of OSA among patients undergoing bariatric~     surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is~     significant on severity of OSA. The Investigators state that we can perform a study without~     a huge number of dropouts.~   "
79811|NCT02012764|"~     This is a 12-month, prospective, observational cohort trial involving Primary Care Trusts~     (PCTs) wishing to take part in the study and the Early Arthritis Clinic (Anti-CCP~     sub-clinic) at Chapel Allerton Hospital. The approximate duration of subject participation~     will be 12 months and the approximate total duration of the study will be 10 years. Patients~     who have not developed inflammatory arthritis within the 12 month period will have the~     opportunity to continue follow up within the clinic on an annual basis with additional~     visits as clinically indicated until the development of IA.~   "
79812|NCT02012751|"~     The Nevus doctor is a dermatoscopy based computer decision support tool to assist general~     practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the~     program Nevus doctor is to help GPs increase their diagnostic accuracy, in particular~     regarding the selection of suspicious PSLs that need biopsy or referral to specialist health~     care for further assessment. The aim of this study is to investigate the diagnostic~     performance of the decision support tool in a primary care setting in Norway. We hypothesize~     that the diagnostic accuracy of the computer program Nevus doctor is better than the~     performance of the GPs.~   "
79804|NCT02012855|"~     The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk~     factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for~     improving the blood lipid response to a subsequent meal; that is, the appearance of fat~     (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly~     before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is~     unfortunately negated if the after-exercise food choice to replace the calories expended~     during exercise is one containing high glycemic index carbohydrates. For example, if a high~     glycemic index carbohydrate is consumed after an evening exercise session, the exercise no~     longer has an effect of lowering triglyceride in the blood after a meal consumed the next~     morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an~     exercise session and then fast until their next meal hours later. The more common practice~     is to consume food immediately after the exercise to enhance recovery and because hunger is~     stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to~     reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To~     date, no studies have examined the effects of consuming a low-glycemic index meal after~     exercise on the blood fat response to a subsequent meal. The specific objective of our~     research is to determine the effect of consuming low glycemic index lentils after an~     endurance exercise session on the blood fat (triglyceride) response to a subsequent meal.~     Twenty-five overweight or obese men will have their blood triglycerides measured four times~     over six hours after a high-fat morning meal following four different conditions, in a~     randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate~     in all four conditions, where the order of conditions for each person is randomized): 1)~     After exercise (90 minutes of moderate intensity walking) is performed the evening before,~     followed by caloric replacement with a high-glycemic index meal (i.e. white bread and~     instant mashed potatoes); 2) After the same exercise is performed the evening before,~     followed by caloric replacement with a lentil-based meal; 3) After the same exercise is~     performed the evening before, followed by fasting; 4) After a no exercise/ no meal condition~     (i.e. control condition). In addition to measuring blood triglycerides we will measure blood~     insulin, free fatty acid, high density lipoproteins, low density lipoproteins, and glucose~     levels as these are also related to cardiovascular disease risk and may be altered with~     exercise and lentil consumption. We will also measure the muscle's ability to burn fat (i.e.~     fat oxidation) by assessing respiratory gases (oxygen consumption and carbon dioxide output)~     after the high-fat meal because we expect exercise and lentils to increase fat oxidation.~     Our expected results are that consuming lentils after endurance exercise will lower the~     blood triglyceride response to a subsequent meal compared to exercise alone or when~     high-glycemic index carbohydrates are consumed after the exercise.~   "
79805|NCT02012842|"~     The aim of this study is to evaluate the effect of periodontal treatment on systemic~     inflammation and quality of life of individuals with metabolic syndrome. There will be a~     randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes~     (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of~     Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of~     metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm~     where it will be immediately periodontal treatment (test group) and another arm which will~     be held later periodontal treatment (control group). The study will last six months , and~     after this period, the control group will receive the same treatment to the test group . A~     socio-demographic questionnaire will be applied by a trained interviewer , so that data on~     income, education , behavioral habits , medical and dental history . Complete periodontal~     examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3~     and 6 months after periodontal treatment . In addition to the tests required for the~     diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after~     periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides ,~     C-reactive protein). Aliquots of plasma from blood collected in each experimental point are~     stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) ,~     Glucagon Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be~     collected gingival crevicular fluid , supra and subgingival biofilm . Versions of the~     questionnaires validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess~     quality of life at baseline and after 6 months of the study . The primary outcome will be~     change in glycated hemoglobin and secondary outcomes will be changes in serum fibrinogen and~     C-reactive protein.The hypothesis of this study considers that periodontal treatment can~     alter the serum levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in~     patients with metabolic syndrome and thereby contribute to improved quality of life. The~     objective of this study is to evaluate the effect of periodontal treatment on systemic~     inflammation and quality of life of individuals with metabolic syndrome.~   "
79806|NCT02012829|"~     Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient~     interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC)~     screening in France The qualitative data indicated that improvement was needed in~     patient-centered communication. Educational material was developed based on these~     triangulated data with two different scenarios to improve communication with patients: one~     for a compliant patient, another for a non compliant patient The hypothesis is that a brief~     intervention on GPs can improve the patients' participation rate to colorectal screening~      Method : cluster randomized control trial (cluster unit : GPs practices) With a brief~     intervention on a randomized population of GPs in the district of Val d'Oise Inclusion~     criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal~     mass screening~   "
79807|NCT02012816|"~     The Centre for Infectious Disease Research in Zambia (CIDRZ) and researchers from the~     University of North Carolina at Chapel Hill (UNC) have partnered to pilot an peer-referral~     incentive program to increase voluntary medical male circumcision (VMMC) uptake in Zambia.~     The program allows each man coming for circumcision to refer up to 5 uncircumcised men in~     their social network for VMMC services and receive a monetary reward for each successful~     referral. The peer-referral program offers several advantages over traditional~     demand-creation approaches that rely on employing mobilizers or community health workers~     (CHWs). The amount of the monetary incentive will be analogous to the amount of incentive~     that CHWs might receive for comparable effort, making the program suitable for large-scale~     expansion. The effect of the peer-referral program on uptake of VMMC services will be~     evaluated using a rigorous methodology proposed by UNC researchers.~   "
79808|NCT02012803|"~     The intention is to compare prospectively operative and conservative early functional~     rehabilitation protocol in treatment of total achilles tendon rupture. To compare these~     treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of~     life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective~     items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range~     of motion between ankles, subjective result, isokinetic calf muscle strength). The~     investigators also study MRI-imaging for both legs and compare including achilles tendon~     elongation and muscle volume correlations to Leppilahti-score results between these two~     treatments. Follow-up time is 18 months.~      Hypothesis is that operative treatment offers no benefit in comparison conservative~     treatment, with identical rehabilitation protocol.~   "
79809|NCT02012790|"~     Migraine is a widespread, debilitating, chronic pain disorder and a major public health~     challenge. Most conventional, pharmaceutical treatments fail to give satisfactory long-term~     relief and their repeated use can have important side effects. This project involves~     implementation of substantial dietary changes in adults with migraine. Our goal is to test~     the hypothesis that a causal relationship exists between migraine symptoms and the amount~     and proportions of foods consumed containing defined amounts of polyunsaturated fatty acids.~      Significant findings supporting the hypothesis will lead to a major shift in both prevention~     and management of migraine and other chronic pain disorders. Emphasis is on low-cost, health~     improvement strategies utilizing specific dietary modifications for pain management, based~     on solid clinical research evidence.~   "
79810|NCT02012777|"~     Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to~     upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose~     of this pilot study is to administer one dose of propanolol to children with sickle cell~     disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single~     dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as~     compared to baseline.~   "
79813|NCT02012738|"~     Escalating violence is omnipresent in South African townships and can be traced back to two~     core mechanisms: a trauma-related hyper-arousal and a positive rewarding perception of~     violence. In the past, there was no therapeutic intervention available addressing both,~     trauma and the so-called appetitive aggression. The University of Konstanz has developed a~     culturally sensitive and scientifically based short-term intervention for the treatment of~     traumatized patients, the Narrative Exposure Therapy (NET), that has proven its~     effectiveness in various randomized clinical studies in different war-affected populations.~     Recently, the NET has been adapted for the forensic offender rehabilitation (FORNET) by also~     addressing the perpetration of violence related to a self-rewarding perception of the~     exposure with violence. It has shown to be effective in reducing the number of committed~     offenses in a perpetrator sample in Burundi and to reduce PTSD symptoms in a perpetrator~     sample in the Democratic Republic of the Congo. In this study, we investigated the~     therapeutic efficiency of FORNET in a randomized clinical control trial with a sample of~     former offenders of the townships of Cape Town. In addition to the previous studies, we~     specifically addressed the context of ongoing stress and linked our findings to epigenetic~     markers of stress and violence. Participants were followed over a period of up to 25-months~     post-treatment. The FORNET was also disseminated to local staff of our collaboration~     partners from the South African Universities and an organization working in the townships to~     warrant sustainability of the therapeutic intervention.~   "
79814|NCT02012725|"~     This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced~     steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current~     clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP~     cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients.~     Participants will not receive a study drug or placebo and will not be randomized. A total of~     250 participants will be enrolled into this study.~   "
79815|NCT02012712|"~     Purpose: To examine the impact of a personal health record (PHR) on medication use safety~     among older adults.~      Background: Online PHRs have potential as tools to manage health information. We know little~     about how to make PHRs accessible for older adults and what effects this will have.~      Methods: A PHR was designed and pretested with older adults and tested in a six-month~     randomized controlled trial. After completing mailed baseline questionnaires, eligible~     computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or~     serve as a standard care control group (n=273). Follow-up questionnaires measured change~     from baseline medication use, medication reconciliation behaviors, and medication management~     problems.~   "
79816|NCT02012699|"~     The objectives of this project at UNMC and other IRB approved sites is to implement and~     maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository~     for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core~     support services for future IRB approved multidisciplinary research on cancer and other~     chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well~     as internal and external research collaborators from different participating~     institutions/centers.~   "
79817|NCT02012686|"~     The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation~     (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after~     thyroidectomy.~   "
79818|NCT02012673|"~     Rationale:~      The combined data from 3 studies outside the Unites States investigating the Lung Volume~     Reduction Coil system (RePneu LVRC) showed statistically significant improvements in~     pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months~     post treatment. 24 months post treatment the improved pulmonary function and exercise~     capacity are slightly decreasing. Retreating the patient with the LVR coil system in other~     parts of the lung could potentially lead to new improvements in lung function, dyspnea,~     exercise capacity and quality of life and may reduce the rate of decline.~      Objective:~      To investigate the safety and feasibility of re-treating patients with severe Chronic~     Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.~   "
79819|NCT02012660|"~     The objective of this study is to explore the relationship between moderate to severe~     hyponatremia and heat.~   "
79820|NCT02012647|"~     The purpose of this study is to examine the brain changes in people with Parkinson's Disease~     (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not~     have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and~     challenging. Deep brain stimulation is an established surgical treatment that is effective~     for the treatment of PD, but the details of why it helps are not known. In order to achieve~     maximum benefits from this treatment, it is important to understand how it changes the~     brain. Specifically, the investigators will study electrophysiology, which is the study of~     how the brain conducts electrical messages to the rest of the body. To do this, the~     investigators will use transcranial magnetic stimulation (TMS), which is a painless and~     non-invasive procedure. They will also conduct motor physiology experiments of the upper and~     lower limbs to collect data about skeletal muscle movement. The data from this study will~     help explain whether the electrical changes in the brain have any relation to the physical~     benefits patients with Parkinson's Disease sometimes receive from DBS surgery.~   "
79821|NCT02012634|"~     A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic~     Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer~   "
79822|NCT02012621|"~     The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate~     (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a~     TFV-based regimen. Using DBS will allow the investigators to assess this simple method to~     measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP~     levels will be lowest in individuals with a detectable viral load and highest in those with~     viral suppression.~   "
79823|NCT02012608|"~     This study is a single-centered, double-blind, two-arm randomized study to determine if oral~     glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving~     Therapy.~   "
80001|NCT02010281|"~     This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of~     magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain~     intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with~     peripheral neuropathic pain.~      The medical device of study: transcranial magnetic stimulator (TMS).~   "
79824|NCT02012595|"~     AIM: Investigate wether there are differences in the parasympathetic nervous system in~     Parkinsons patients compared to controls.~      MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous~     system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged~     40-80 in our study. The participants will receive a careful medical examination, including a~     neurological examination, as part of the inclusion process. The subjects also have an MRI~     scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper~     abdominal region and once for the head region. For evaluating the function of the~     parasympathetic nervous system gastric emptying time, heart rate variability and salivary~     flow will be measured. These measureless will be correlated to the PET findings.~      PERSPECTIVES: The study will potentially result in the development of a PET ligand for~     imaging the parasympathetic nervous system. This will have applications for research in~     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic~     nervous system is involved~   "
79825|NCT02012582|"~     In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and~     pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with~     moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males)~     receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts~     (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study~     for all patients will be Day 14; adverse events and concomitant medications will be~     documented throughout the study.~      Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of~     metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of~     VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure~     heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG,~     laboratory examinations (clinical chemistry, liver function, haematology/coagulation,~     urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined~     in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure~     (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline,~     pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy~     Intensity Level (TIL).~   "
79826|NCT02012569|"~     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the~     bleeding time in the donor site of skin grafting.~   "
79827|NCT02012556|"~     The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1)~     profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated~     administration once daily for 14 consecutive days. Secondary objectives include the~     evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous~     injections.~   "
79828|NCT02012543|"~     The administration of agar jelly may increase the number of defecation and the volume of~     feces, and then may improve fecal condition in chronic constipated patients.~   "
79829|NCT02012530|"~     Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid~     Intra-articular Knee Injections for Early Cartilage Defects in the knee.~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: The participating patients will be divided into two groups, each group~     receiving either one of the treatment modalities. This study will be randomised. Both~     procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The~     post-operative rehabilitation process will be the same for both groups.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each group~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months following the surgery by visits to the clinic and assessed clinically. The surgical~     outcomes will be measured by by IKDC, KOOS and Lysholm scores.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other by~     studying pain relief, improvement in function.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
79830|NCT02012517|"~     The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing~     breast reconstruction who have drains placed for several days after surgery is~     controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour~     antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen~     consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until~     the removal of the drains. Patients will sign an informed consent form prior to the surgery~     and will be randomized to one of the antibiotic regimens. Patients will be closely followed~     up to one year after surgery. The number of surgical site infections according to the NNIS~     criteria and loss of breast implants will be compared between the two groups.~   "
79831|NCT02012504|"~     The primary objective is to evaluate the improvement of antidepressant monotherapy on~     depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical~     Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major~     depressive disorder (MDD) and generalized anxiety disorder (GAD)~   "
79832|NCT02012491|"~     The purpose of the study is to compare the effectiveness of combination treatment~     (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol~     (standard of care) for the management of early pregnancy failure.~   "
79858|NCT02012153|"~     The general aim of the present study is to test a cell therapy with autologous ex-vivo~     expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor~     kidney transplant recipients. MSCs will be prepared accordingly to established protocols,~     starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4~     months before kidney transplant. From these samples, MSCs will be expanded in Good~     Manufacturing Practice (GMP) approved facilities and used for the present study in patients~     undergoing kidney transplantation.~   "
79859|NCT02012140|"~     Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause~     mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS).~     The benefit of this study would be to demonstrate that ticagrelor therapy is associated with~     equivalent platelet inhibition irrespective of the disease status in patients undergoing~     PCI.~   "
79860|NCT02012127|"~     The purpose of this study is to describe most characteristic association of signs and~     symptoms present at the time of acromegaly diagnosis.~   "
79833|NCT02012478|"~     Despite advances in medical therapy for diabetes, significant numbers of patients fail to~     achieve adequate blood glucose control. Diabetic patients who engage in more self-care~     behaviors have better glycemic control, as measured by HbA1C. Patient activation, defined~     as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the~     performance of these self-care behaviors.~      There is a growing literature on diabetes behavioral change interventions; however~     interventions are often developed and implemented without consideration of patients~     readiness to engage in lifestyle changes. Additionally, patient-tailored interventions~     require intensive clinical and financial resources, making them difficult to integrate into~     clinical practice. Mobile text messaging (SMS) programs have been successfully used to~     promote smoking cessation, alcohol cessation, and weight loss in diverse patient~     populations. SMS interventions for diabetes have also been developed, but they have been~     designed primarily to provide feedback on blood glucose management, rather than to motivate~     behavioral change. The few studies that included motivational content as a primary feature,~     did not tailor their intervention to a patient's readiness for change or rigorously describe~     their motivational intervention, and show limited efficacy.~      To address these concerns, we will perform a three-month randomized controlled pilot study~     to develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to~     patient level of activation for patients with poorly controlled type II diabetes.~   "
79834|NCT02012465|"~     There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced~     elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly~     high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior~     study by Muthala et al. (unpublished data) found a relationship between insulin requirements~     needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In~     this pilot study, through an endocrine consult team, a weight-based, steroid dose-based~     insulin protocol will be implemented for the management of hyperglycemia in lymphoma~     patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia~     incidence.~   "
79835|NCT02012452|"~     The purpose of this study is to examine whether tobacco affects recovery from PTSD. There~     are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects~     treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco~     compared to those who continue to use and (3) to explore how tobacco use and tobacco~     withdrawal symptoms change during PTSD treatment.~   "
79836|NCT02012439|"~     Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis~     (MS) that is typically inadequately treated by medications alone. There is a critical need~     to develop and evaluate innovative psychosocial interventions that have the capacity to~     effectively target the multidimensional nature of MS pain. Cognitive Therapy (CT) is one~     psychosocial treatment that has been found to be a potentially beneficial treatment for~     chronic MS pain. This approach teaches patients to identify and replace unhelpful thoughts~     about pain with helpful, more adaptive thoughts. In addition, over the past decade there has~     been a steady upsurge of research examining mindfulness meditation-based therapies for the~     treatment of medical conditions, including symptoms associated with MS. Mindfulness~     mediation involves training the mind to disengage from automatic thinking patterns to~     mindfully perceive, in a non-judgmental manner, one's moment-to-moment experiences. This~     meditation technique teaches patients to become aware of thoughts, emotions, and physical~     sensations and to recognize that these are transient experiences that can be mindfully~     perceived, accepted and let go. A promising, more recent trend in treatment development~     research is the integration of tradition CT with mindfulness-based meditation, an approach~     referred to as Mindfulness-Based Cognitive Therapy (MBCT). To date, we are the only research~     group that has adapted and tested a manualized MBCT approach for the treatment of painful~     medical conditions. Thus, the proposed pilot randomized controlled trial aims to utilize~     state-of-the-art research methodology to evaluate traditional Cognitive Therapy (CT)~     compared to an innovative, newly developed Mindfulness-Based Cognitive Therapy (MBCT)~     protocol for the treatment of chronic pain in individuals with multiple sclerosis. This~     study will answer three primary questions: (1) Do these treatments work to improve chronic~     pain for individuals with MS and do these treatment also improve associated symptoms such as~     depression, fatigue, and engagement in daily activities?; (2) How do these treatments work~     in individuals with MS, i.e., what factors underlie improvement in outcomes during~     treatment?; and (3) What are the individual person characteristics that best predict~     outcome? This will be the first study to examine MBCT within an MS population. The results~     will lead to the emergence of a novel, much needed additional psychosocial treatment option~     for patients with chronic MS pain.~   "
79837|NCT02012426|"~     The aim of the current study is to demonstrate that a commercial weight management diet~     (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy~     intake during ad-libitum meals and over a full day. We further seek to demonstrate the~     sustainability of this effect following 12- week weight loss on the weight management~     program.~        -  We hypothesise that formulated (low energy) meals will lead to decreased hunger,~          greater fullness and reduced desire to eat compared to standard meals.~        -  We hypothesise that the commercial weight management program will lead to greater~          weight loss compared to control program.~        -  We hypothesise that formulated meals (high consumer acceptance) will improve hedonic~          control over eating (lower wanting for high fat food)~        -  We hypothesise that the commercial weight management program will improve hedonic~          control over eating (reduced experience food cravings)~   "
79838|NCT02012413|"~     PST (pulsed signal therapy) is a unique form of pulsed electromagnetic field therapy (PEMF)~     for stimulating healing of damaged structures such as cartilage, bones and soft tissues. The~     physical effect of the pulsed electromagnetic field (PEMF) has been focus of research in~     various studies, with cartilage being the most studied, and which has demonstrated an~     increase in the synthesis of proteoglican and collagen in vitro. A T2 MAP diagram MRI is~     considered a method in evaluating the indirect biochemical quantity of articular cartilage~     which may traduce functional behavior of the articular cartilage. This is an randomized,~     control and double blind clinical trial. The main objective is to evaluate in vivo the~     effect of PST on patella cartilage in patients with chondromalacia through the T2 MAP~     diagramed MERI technique. The secondary objective is to evaluate clinical improvement~     regarding anterior knee pain after PST intervention.~   "
79839|NCT02012400|"~     The purpose of this study is to assess the effects of regular exercise on physical fitness,~     asthma control, and quality of life among adult asthmatics.~   "
79840|NCT02012387|"~     To demonstrate the efficacy and safety of Omalizumab in a new indication, that is~     cholinergic urticaria.~   "
79879|NCT02011880|"~     The purpose of this clinical research study is to learn if the clinical effects of combined~     Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in~     improving the quality of life and shrinking and slowing the growth of the cancer in women~     with breast cancer bone metastasis.~   "
80002|NCT02010268|"~     This study aims to evaluate a clinico-biological predictive score, associating the faecal~     calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.~   "
79841|NCT02012374|"~     In this study the investigators are examining the effectiveness of intensive speech therapy~     in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses~     constrained or unconstrained to speech. Both treatments involve massed practice~     communicating, using intensive language action therapy 3 hours/day, 5 days/week for two~     weeks, followed by six months of a home practice program. One treatment stresses spoken~     responses as the preferred expressive modality during intensive therapy. Before and after~     treatment, and following the home practice program and a period of no practice, the~     investigators will administer several tests and discourse samples to examine changes~     associated with the treatments. Participants will also undergo structural and functional MRI~     testing at these time points. The investigators will also attempt to quantify the degree to~     which improvements following intensive language therapy and home practice correlate with~     changes in Quality of Life measures as perceived by both participants with aphasia and their~     significant others. It is hypothesized that, whereas both treatments will lead to~     improvements in naming practiced words and communicating, outcomes will be enhanced for the~     group randomly assigned to the constraint condition. Moreover, performance will be~     enhanced on words practiced during the home practice program, including those that were not~     practiced during intensive therapy. Improved naming will correlate with modulation of~     'signature' language and attentional networks, whose variability will depend on remaining~     viable brain structures. Initial severity and site/extent of lesion should predict patients'~     ability to transfer gains in naming to improvements in discourse.~   "
79842|NCT02012361|"~     The purpose of this study is to determine whether breathing in helium reduces indications of~     injury to the skeletal muscle seen in blood tests after knee replacement surgery.~      The ability to reduce the risk of skeletal muscle injury may help improve patient safety by~     providing protection to the area of the body having its blood supply interrupted during a~     particular surgery.~   "
79843|NCT02012348|"~     This study will recruit up to 10 healthy volunteers. An avirulent strain of S. pyogenes will~     be applied to their forearms after washing each of their forearms with different types of~     soap, one with an antimicrobial compound, and the other without an antimicrobial compound.~     After several hours of incubation, the subject's forearms will be swabbed for bacteria. The~     forearms will then be cleansed with antibacterial soap and water followed by 70% ethanol.~     The bacterial swabs will be analyzed and compared between the different soaps that were used~     to cleanse each digit prior to the application of S. pyogenes. The investigator expects the~     number of bacteria surviving on the skin of forearms washed with antimicrobial soaps will be~     fewer than with control soap.~   "
79844|NCT02012335|"~     The purpose of this study is to determine whether combination of ketamine plus~     electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.~   "
79845|NCT02012322|"~     Goal: The investigators propose to test the feasibility of giving the supplement coenzyme~     Q10 (Q10) improves symptoms and subjective health in an aging population.~      Rationale: Direct empirical evidence has supported benefit of Q10 to many symptoms such as~     fatigue, muscle pain, and cognition. In addition, Q10 has also been reported to benefit~     other symptoms including headaches, sleep disturbances, and breathing problems. This~     provides a strong rationale for testing whether Q10 will have similar benefit to these~     symptoms in an aging population.~      Method: 44 aging subjects will participate. The design is a 9 month, randomized,~     double-blind, placebo-controlled crossover study. Each subject will be crossed over~     between high dose Q10 (300mg), low dose Q10 (100mg), and placebo, receiving each agent for 3~     month periods. Neither subjects nor investigators will know which substance each subject is~     receiving in which phase. Subjects will be randomly assigned to one of six arms.~      Assessments: Assessments will include feasibility of study, subjective quality of life,~     energy, and metabolic and lipid panels. Analyses will show whether Q10 led to improvements~     when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses;~     and whether people with certain symptoms or characteristics get more benefit than people~     with other symptoms or characteristics.~   "
79846|NCT02012309|"~     HIV infection is complicated by high rates of infections and cancers which are often the~     cause of death rather than the HIV/AIDS virus itself. Treatment of HIV with antiretroviral~     medications has decreased the frequency of many complications by over 90%, but bacterial~     pneumonia remains extremely high. Current vaccines are not very effective in preventing~     these infections in patients with HIV infection. The investigators are studying the cells (B~     cells) that make antibodies to fight infection by binding to and killing bacteria. The goal~     is to understand how HIV impairs the ability of B cells to make antibodies in sufficient~     quantity and of sufficient quality to protect patients with HIV to learn how to enhance~     protection against these infections. The investigators also seek to understand the role of~     the bacteria (specifically Streptococcus pneumoniae) that normally live in the nose and~     throat in the development of pneumonia and other infections.~   "
79847|NCT02012296|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     enzalutamide and mifepristone when given together and to see how well they work in treating~     patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth~     of prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may~     lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is~     more effective with or without mifepristone in treating patients with prostate cancer.~   "
79848|NCT02012283|"~     This study is being done to determine the differences in liking of vegetables between~     individuals based on a variety of variables, and to see if flavoring various vegetables~     differently with spices changes the intake of those vegetables.~   "
79894|NCT02011685|"~     This study will assess the comparative effectiveness, cost-effectiveness and sustainability~     of two telemonitoring interventions in reducing blood pressure and recurrent stroke among~     450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood~     pressure telemonitoring supplemented with individualized, culturally tailored~     telephone-based nurse case management will have greater effects on blood pressure reduction~     and stroke recurrence and, while it will be more costly, it will also be more cost-effective~     than home blood pressure telemonitoring alone. Results of this study will provide strong~     empirical evidence to inform clinical guidelines and practice, which may lead to reductions~     in stroke disparities in the United States.~   "
79849|NCT02012270|"~     Principles= Prevention of incision hernias by primary closure of mid line laparotomies with~     the best-evidenced suture techniques.~      Background:~      Surgical practice of abdominal wall closure continues to rely largely on tradition rather~     than high-quality level I evidence. Incisional hernia after laparotomy for treatment of~     abdominal aortic aneurysm (AAA) has a high incidence.~      At this moment the best results in a prospective randomised clinical trial considering~     incision hernia rates and wound infections, have been reported by the surgeons from the~     Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least~     4/1 and using many small stitches will be described in the protocol as the Principles~     Technique. We want to explore if these results can indeed prevent incision hernias~     significantly if implemented with training and tutoring.~      Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to~     learn the Principles, will be asked to monitor a cohort of AAA patients using their current~     sutures and surgical techniques. Some of the vascular surgeons will undergo training and if~     wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA~     patients will be closed according to the Principles and monitored. The results of these 120~     patients will be compared to the control group consisting of patients closed with the~     conventional technique by non--‐trained surgeons. Primary endpoint:The incidence of incision~     hernias at 12 months will be determined by clinical examination.~      Data management and ownership:~      The data will be collected on a paper form and will be introduced is a database (SPSS~     Statistics, IBM) from which statistical analysis will be made.~   "
79850|NCT02012257|"~     AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior~     alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to~     second premolar teeth of one quadrant can be anesthetized. The aim of the present study was~     to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior~     positions compared to commonly administrated site.~   "
79851|NCT02012244|"~     The purpose of this study is to compare postoperative immune function (e.g. NK cell~     activity) of fentanyl-based analgesic regimen versus local anesthetic wound~     infiltration-based anlagesic regimen after laparoscopic colorectal surgery~   "
79852|NCT02012231|"~     The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics~     (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional~     objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the~     Extension Cohorts (Phase IIa portion).~      The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective~     tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with~     advanced BRAF-mutated cancers.~   "
79853|NCT02012218|"~     The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects'~     subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who~     have responded inadequately to preceding adjunctive drug therapy.~   "
79854|NCT02012205|"~     Background: Persistent nonspecific low back pain (PNSLBP) is one of the most common low back~     pains worldwide. Many interventions were tried including wet cupping which is commonly used~     for pain conditions in Saudi Arabia and other parts in the world but without solid~     scientific evidence.~      Aims: This study aims at determining safety and efficacy of wet cupping for treating PNSLBP.~      Methods: This is a randomized wait-listed controlled clinical trial. Eligible patients with~     history of at least 3 months of PNSLBP will be randomized in to two groups, 45 patients~     each. The first group will be given wet-cupping treatment at two acupuncture points of~     urinary Bladder (BL) meridians among the BL23, BL24 and BL25, 6 times within 2 weeks. The~     second group will serve as a control group. Usual care, including providing brochures for~     exercise, general advice for PNSLBP and acetaminophen, will be allowed in both groups.~     Separate assessors participated in the outcome assessment. Investigators will use the 0~     to100 numerical rating scale (NRS) for pain, the McGill Pain questionnaire for pain~     intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and to assess acetaminophen~     use and safety issues.~      Expected Results: To provide data on the safety and effectiveness of wet cupping in treating~     PNSLBP and open the way for integrative medicine in Saudi Arabia~   "
79855|NCT02012192|"~     Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900~     deaths annually in Europe. The predominance of aggressive Type II tumours, which are~     characterised by a high frequency of p53 mutations, and primary or acquired resistance to~     platinum-based chemotherapy profoundly contribute to the high mortality rate. With current~     standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian~     cancer patients is only 14 month. There is a pressing need for more effective, innovative~     treatment strategies to particularly improve survival in this subgroup of EOC patients. This~     is a drug strategy targeting a central driver of tumour aggressiveness and metastatic~     ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition~     mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib.~     The first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new~     combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second~     part (randomised Phase II) will examine the efficacy of Ganetespib in combination with~     standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.~   "
79856|NCT02012179|"~     SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate~     the efficacy of a low sodium containing diet on a composite clinical outcome composed of of~     all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department~     visits. The hypothesis of this study is that patients following a low-sodium containing diet~     will have fewer clinical events (fewer hospital readmissions or emergency department visits,~     longer survival) than those randomized to Usual Care.~   "
79857|NCT02012166|"~     This is a study to assess the pharmacokinetics, safety, and tolerability of sequential~     single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending~     on treatment assignment in young healthy male participants. In Part 2 of this study,~     sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on~     treatment assignment will be evaluated. The primary hypothesis of the study is that at least~     one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared~     to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.~   "
79861|NCT02012114|"~     Preventing late onset of Cystinosis such as neurological complications and improving~     compliance to cysteamine treatment remain major challenges in management of subjects with~     cystinosis.~      This study is designed to describe the relationship between compliance of patients with~     cystinosis treated with cysteamine and treatment efficacy and to understand the~     pathophysiologic mechanism of neurological disorders. Is cysteamine crossing the blood brain~     barrier? What is the impact of cystine accumulation in Cerebro Spinal Fluid and Central~     Nervous System? Our Primary objective is to study the relationship between compliance of~     patients treated with cysteamine and the WBC cystine level.~      Secondary, the study will assess relationship between compliance to cysteamine and its~     neurological consequences.~      The expected duration of the study is 48 months. The enrolment period is 24 months and the~     study participation of each subject is 24 months. Eligible participants are male and female~     (age > 4 years) with confirmed diagnosis of cystinosis and receiving any oral cysteamine~     treatment: Cystagon or RP103.~      The compliance under cysteamine is measured using electronic devices, accountability of~     study treatment, and information in patients' diary. Specific memory and visuoperceptual~     tests are performed at the beginning and at the end of patients'participation. Nuclear~     Magnetic Resonance spectroscopy is used to detect possible sites of cystine accumulation in~     the CNS and their relationship with compliance to cysteamine treatment. NMRS is also used to~     establish a relationship with the neuropsychological status of the subject.~      To describe absorption, distribution and elimination of cysteamine, and its metabolic~     pathways, and to determine the concentration effect and dose effect relationship, blood~     samples are performed at each study visit. A lumbar puncture is also proposed to~     participants to verify if cysteamine is crossing the blood brain barrier. New tools are used~     to compare metabonomic networks in patients with cystinosis and their controls.~   "
79862|NCT02012101|"~     The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV),~     playing the role as a rescue therapy , are effective in relieving exertional dyspnea in~     stable severe COPD patients.~   "
79863|NCT02012088|"~     The Phase II study proposed here assesses the hypothesis that replacing doxorubicin by~     Myocet® in the R-CHOP regimen would yield comparable antitumour efficacy with a lower~     cardiotoxicity for first-line treatment in elderly patients with non-localised~     DLBCL/Follicular lymphoma grade IIIb~   "
79864|NCT02012075|"~     The aim of present study is to evaluate the efficacy and safety of Extended-Release~     Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or~     Moderate Chronic Heart Failure.~   "
79865|NCT02012062|"~     The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute~     treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally~     advanced NPC. Three hundreds and twenty patients will be recruited into this study.~   "
79866|NCT02012049|"~     The purpose of this study was to conduct the bioequivalence (biological equivalence of two~     preparations of a drug) test in healthy adults with Risperdal OD Tab. 2mg of Janssen Korea~     as the investigational drug and Risperdal Quicklet Tab. 2mg as the control drug.~   "
79867|NCT02012036|"~     The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder~     Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients~     undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical~     practice.~   "
79868|NCT02012023|"~     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality~     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are~     undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate~     the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed~     to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were~     compared to those of the loop ileostomy (LI) method.~      In fact when we told the patients about the tube ileustomy's effect and risk, almost all the~     almost all of my patients like to choose tube ileustomy(I have study this method for long~     time and have good expeience, and my patients either choose tube ileostomy directly or let~     me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy~     and have no control group.~   "
79869|NCT02012010|"~     This study is to perform a randomized controlled trial of comparing the manual syringe~     infusion method with the conventional pump infusion method to clarify if the manual syringe~     infusion method really needs less amount of distension medium.~   "
79870|NCT02011997|"~     This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to~     evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus~     Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.~   "
79871|NCT02011984|"~     Non-randomized multicenter post-market study to confirm the long-term safety and~     effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage~     stent system for revascularization of de novo stenotic lesions in the superficial femoral~     artery in 100 compliant patients suitable for stent angioplasty.~      The CE-approved device will be used according to its intended use. Beyond the standard of~     care no further interventions are scheduled. Therefore, this trial is subject to the~     exception to the rule §23b of the German Medical Device Act (MPG), which includes the~     national implementation of EC directive 93/42/EEC.~   "
79872|NCT02011971|"~     Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential~     efficacy and safety of different dosages of vinpocetine in improving cognition.~   "
79873|NCT02011958|"~     The overall objective of this trial is to identify a safe and effective treatment for~     visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.~      Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine.~      Patients who do not undergo treatment failure will be given a VL prophylactic treatment with~     Pentamidine one month after the end of the study treatment.~   "
79874|NCT02011945|"~     The purpose of this study is to find a dose of Nivolumab that can be safely added to~     Dasatinib in patients with Chronic Myeloid Leukemia.~   "
79875|NCT02011932|"~     The purpose of this study is to determine the progression of chronic hepatitis C patients~     infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease~     progression in chronic hepatitis C.~   "
79876|NCT02011919|"~     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate~     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device~      Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the~     breast fibroadenoma using the TH-One device Secondary objective: To evaluate the~     tolerability of the HIFU using the TH-One device~   "
79877|NCT02011906|"~     The aim of this study is to determine the effects of omega 3 supplementation and its~     concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the~     expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in~     the patients with coronary artery disease~   "
79878|NCT02011893|"~     The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for~     the treatment of chronic intractable pain of the trunk and/or limbs.~   "
79880|NCT02011867|"~     The custom made device was produced by Med-El Company. It has a cork like stopper instead~     of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of~     different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm~     (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations.~     Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with~     initial prototype of the cork electrode had to be revised because of persistent oozing~     around the electrode. Another patient had slow extrusion of the electrode most probably due~     to CSF (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF~     fistula.~      CSF fistula in inner ear malformations is a serious situation which may lead to recurrent~     meningitis. The new cochlear implant electrode with cork stopper looks promising in~     preventing the postoperative CSF leak around the electrode.~   "
79881|NCT02011854|"~     Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor~     of limb function recovery.This research aims to observe the effect and safety of Acupuncture~     and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke~     Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in~     community hospital.~   "
79882|NCT02011841|"~     The aim of this study is to evaluate whether long-term rifaximin administration reduces~     spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.~   "
79883|NCT02011828|"~     The objective of this study is to determine the effects of cholecalciferol treatment on~     inflammation and insulin resistance, in patients on hemodialysis that are previously treated~     with paricalcitol.~      Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the~     skin. This compound is then converted to calcidiol (25(OH) D3) in the liver, whereupon~     calcidiol is converted in the kidney to calcitriol (1,25(OH)2D3), the active form of vitamin~     D. However, recently it has been shown that deficiency of either calcidiol or calcitriol is~     associated with inflammation, insulin resistance and increased mortality in the general~     population. Furthermore, when both calcidiol and calcitriol were deficient, the mortality~     risk was much higher than the deficiency of either alone. A possible explanation is that~     some of the non-renal tissues might critically depend on the endogenous conversion of~     calcidiol to calcitriol and not on circulating levels of calcitriol. Thus, low circulating~     levels of calcidiol might be associated with tissue level functional calcitriol deficiency~     despite adequate circulating levels of calcitriol.~      Therefore, the hypothesis is that:~        1. In non-diabetic hemodialysis (HD) patients treated with therapeutic doses of~          paricalcitol (an analog of calcitriol), calcidiol deficiency is associated with~          inflammation and insulin resistance and~        2. In calcidiol deficient, non-diabetic HD patients with inflammation and treated with~          therapeutic doses of paricalcitol, cholecalciferol will reverse the calcidiol~          deficiency and thereby, reduce inflammation and insulin resistance.~      Interleulin-6 (IL-6) is thought to play a central role in insulin resistance by~     down-regulating glucose transporter-4 messenger RNA. Furthermore, IL-6 levels are~     significantly negatively associated with calcidiol levels, therefore will be measured as the~     primary outcome.~   "
79884|NCT02011815|"~     The purpose of this study is to explore the possible association between the circadian~     disruption and cancer progression.~   "
79885|NCT02011802|"~     Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as~     an acute abscess in approximately 50% of patients or as a discharging painful sinus.~     Patients may experience lengthy healing times resulting in considerable morbidity and~     disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide~     surgical excision and at the end of the procedure, the wound is dressed with an alginate~     dressing (Algosteril®).~      The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to~     Alginates that are standardized dressings after pilonidal sinus excision during a period of~     75 days. The main objective is to show a difference of 20% of wounds completely healed in 75~     days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to~     70% of wounds healed with Sorbact TM.~   "
79886|NCT02011789|"~     Limonoids are compounds found in citrus juices, seeds and peel. Some research shows that~     they reduce blood cholesterol and also reduce the incidence of several forms of cancer.~     Although these compounds are part of the natural human diet, the dose required to provide~     health benefits and the risks associated with the intake of high doses by humans have not~     been studied. This study will examine metabolism, safety, lipid-lowering and~     anti-inflammatory effects of limonoids. The dose of limonoids in this study is equivalent to~     that found in six 8 oz glasses of orange juice per day. The investigators hypothesize that~     limonin glucoside supplementation will reduce total cholesterol, LDL cholesterol, ratio of~     LDL and HDL cholesterol, number of LDL particles, and serum markers of inflammation.~   "
79887|NCT02011776|"~     The purpose of this study is to evaluate the effectiveness of fluorometholone combined with~     sodium hyaluronate eye drops in the treatment of Sjögren syndrome.~   "
79888|NCT02011763|"~     The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to~     confirm the good safety profile of the vaccine.~      Primary objective:~        -  To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered~          6 months apart, in subjects aged 12 months to 15 years.~   "
79889|NCT02011750|"~     This is an exploratory study in Egypt that will combine a treatment trial among early course~     schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically,~     the study will test the provocative results from animal studies indicating an impact of~     Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether~     exposure to TOX is associated with other cognitive and behavioral changes, as well as~     changes in overall social function. We will also explore the relative efficacy of Sodium~     Valproate (Depakote, DEP) in improving clinical and overall social function among TOX~     exposed and unexposed patients.~      Hypotheses~        1. At baseline, TOX exposure is associated with increased novelty seeking, clinical~          severity, and impaired cognitive and overall social function in patients with SZ.~        2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in~          SZ, particularly among TOX exposed SZ patients.~        3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection~          (VIP and TH levels).~   "
79890|NCT02011737|"~     The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil~     75mg once daily for the improving clearance of ureteral or renal stones.~   "
79891|NCT02011724|"~     The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg~     ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful~     VLU.~   "
79892|NCT02011711|"~     Clinical study to determine if hormonal contraceptive use effects cells that fight infection~     (i.e., immune cells).~   "
79893|NCT02011698|"~     this study has the aim to analize the correlation between three different methods of mesh~     fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and~     recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy~   "
79895|NCT02011672|"~     Background: Recent advances in science have established a fundamental role for low grade~     chronic inflammation in mediating all stages of most of the non-communicable diseases~     associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy~     and its components are known to exert beneficial effects on postprandial hyperglycemia. This~     study investigates if dairy, normal and enriched, can reduce chronic inflammation via~     improvement in glucose regulation.~      Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose~     regulation and postprandial inflammation with the effect of a standard milk drink, within a~     population of overweight, apparently healthy subjects.~      Study design: The study is designed as a double-blind randomized placebo-controlled parallel~     trial during 7 weeks, during which the test and reference products will be consumed at home.~      Main study parameters/endpoints: The difference in absolute change in fasting blood plasma~     concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in~     postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the~     treatment period, between subjects consuming the test and reference product.~   "
79896|NCT02011659|"~     To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of~     gynecologic patients undergoing laparoscopic surgery after scheduled administration of~     intravenous Ramosetron during hospital stays.~        -  Randomized controlled arm : Placebo versus Ramosetron injection~        -  Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs~          after surgery~   "
79897|NCT02011646|"~     Few obesity prevention programs have produced weight gain prevention effects that persist~     over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in~     duration, making implementation difficult and costly. The 2010 US Preventative Services Task~     Force (USPSTF) recommendations for treating child & adolescent obesity state that programs~     should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and~     behavioral counseling, and that programs with < 25 hr usually do not produce improvements.~     The implication is that, if centers cannot provide this level of service (as most cannot),~     it is not worth providing any kind of treatment at all. In extreme exception to this, an~     intensive 3-hr non-restrictive obesity prevention program involving participant-driven~     healthy lifestyle improvement plans designed to bring caloric intake and output into balance~     (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset~     relative to alternative interventions and assessment-only controls through 3-yr follow-up.~     We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample~     of primarily low SES, minority adolescents and young adults who are overweight and report~     body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk~     factors for obesity. We will test the hypothesis that participants assigned to the Healthy~     Weight vs. control intervention will have significantly lower BMI and % body fat during~     follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and~     eating disorder symptoms. 300 adolescents and young adults at high risk for future weight~     gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder~     symptomatology will be randomized to Healthy Weight or weight control educational video.~     Participants will complete assessments of BMI, body composition, potential mediators, and~     other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the~     USPSTF recommendations statement, we propose to show that a 6-hr intervention led by~     graduate students can produce significant reductions in risk for both obesity and eating~     disorders, suggesting this inexpensive and brief intervention could and should be rolled out~     nationwide.~      Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases~     in BMI, % body fat, and risk for onset of obesity during follow-up.~      Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body~     dissatisfaction, depressive symptoms, and eating disorder symptoms.~      NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER~   "
79898|NCT02011633|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and~     co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state,~     respectively.~   "
79899|NCT02011620|"~     Type 2 diabetes mellitus (DM) is becoming a leading global epidemic. DM affects several~     systems in the body. Most of the complications encountered in DM are attributed to~     uncontrolled hyperglycemia or poor glycemic control. Hyperglycemic stress tends to damage~     the inner lining of the small blood vessels (endothelium). Normally, the endothelium~     releases a chemical substance called nitric oxide (NO) which relaxes the blood vessels and~     also prevents blockade of these vessels. Therefore damage to the endothelium (endothelial~     dysfunction) results in diminished levels of NO which ultimately leads to occlusion of these~     small blood vessels (microvascular occlusion). Microvascular occlusion of vessels supplying~     the eyes, kidneys and nerves leads to serious complications like diabetic retinopathy,~     nephropathy and neuropathy.~      Of late, the skeletal system has emerged as another vulnerable target of diabetic~     microvascular disease. Patients with DM have an increased risk of developing fractures.~     Certain predisposing factors like diabetic neuropathy and visual disturbances (retinopathy~     and cataract) increases the likelihood of fractures in DM. More recently, evolving research~     has demonstrated NO's prospective role in bone preservation. Earlier studies have also~     validated the use of nitrates (donor of NO) in improving bone strength and reducing the risk~     of fractures.~      So far no study has investigated the effect of nitrates on endothelial function and bone~     microarchitecture in patients with diabetes. The investigators therefore propose to~     investigate the influence of nitrates on endothelial dysfunction and bone integrity in~     patients with type 2 diabetes. 40 patients with type 2 DM will be recruited into the study;~     20 patients will receive 20 mg of oral isosorbide mononitrate daily and the other 20 will~     not receive the study drug. The investigators hope to demonstrate an improvement in~     endothelial function (by measuring skin blood flow) and bone integrity (by measuring markers~     of bone formation and bone resorption and bone mineral density - BMD) following 6 months of~     nitrate therapy.~   "
79900|NCT02011607|"~     We propose to collect the data of vital signs and anesthesia medications administered in a~     subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be~     analyzed to see any relation between the preoperative risk factors, procedure, type of~     anesthesia and the airway intervention. The adverse events that will be automatically~     recorded and later analyzed will be number of apnea episodes (described as no respiration~     for at least 30 seconds) duration of each apnea, number and duration of each desaturation~     event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of~     less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The~     airway interventions that will be recorded will be anything other than considered being~     routine. This includes LMA insertion, endotracheal intubation and the need to withdraw~     gastroscope to facilitate face mask ventilation. We also propose to monitor their~     awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor~     that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any~     correlation between any unwanted events and the sleep depth.~   "
79901|NCT02011594|"~     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is~     advantageous for advanced esophageal cancer patients in combination with chemotherapy or~     radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to~     advanced esophageal cancer patients is not known.~   "
79902|NCT02011581|"~     The purpose of this research study is to learn more about how our body produces sugar,~     breaks down fat for fuel, and makes insulin (the major hormone that controls the production~     of blood sugar and fat breakdown) during a 24-hour day and how body fat and muscle are~     involved in these processes.~   "
79950|NCT02010944|"~     This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose~     combination (FDC) tablets containing solifenacin succinate and mirabegron with the~     co-administration of single entity tablets (SET), at three dose strengths.~   "
79951|NCT02010931|"~     A retrospective analysis of historical data looking at relapse free survival and overall~     survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia~     patients.~   "
79903|NCT02011568|"~     This trial is currently a single-center, randomized, double-blind investigator initiated~     prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The~     plan is to expand the trial shortly as a multi-center project. The patients for this study~     will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The~     aim of this study is to determine whether neurologic outcomes at six months are improved~     with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia~     (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with~     ROSC defined as the resumption of sustained perfusing cardiac activity.~      The primary outcome will be the proportion of patients experiencing death or a poor~     neurologic outcome at six months after out of hospital cardiac arrest.~   "
79904|NCT02011542|"~     The overall objective is to determine whether Visbiome will improve 1) intestinal symptoms~     of Irritable Bowel Syndrome (IBS) and 2) non-intestinal symptoms (fatigue, joint pain,~     insomnia, general stiffness and headache) associated with IBS. All of these symptoms are~     part of the Gulf War (GW) illness.~   "
79905|NCT02011529|"~     This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for~     patients with schizophrenia. The aim of this innovative mental health center-based team~     intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients~     with poorly controlled type 2 diabetes. The study will be conducted in two phases over the~     2-year grant period.~      Phase 1. Development of the adapted TEAMcare intervention and training of team members.~      Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients~     at Harborview Mental Health Services with schizophrenia and poorly controlled type 2~     diabetes. The intervention involves the management of subjects' diabetes, hypertension, and~     hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at~     supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).~      The primary aim of this pilot research grant is to evaluate the feasibility of implementing~     this complex intervention, in order to guide the design of a larger scale efficacy study~     (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and~     6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.~   "
79906|NCT02011516|"~     Studies show that certain reminders of drug use such as the sight of someone using~     marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users~     to smoke marijuana. We are measuring the brain and behavioral responses of marijuana~     dependent individuals to these reminders (cues) We will examine brain responses during cue~     exposure and determine whether these responses are associated with treatment outcome.~      We are testing the hypothesis that the medication baclofen reduces brain responses during~     marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is~     FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional~     magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana~     cues. fMRI is a painless technique that takes special pictures of the brain (or other parts~     of your body). It does not involve radiation or injections.~      Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%~     chance of receiving baclofen. Neither the participant nor study personnel will know whether~     participants are receiving baclofen or placebo. Participants will also receive twice weekly~     psychosocial treatment with a certified clinician. Twelve weeks of treatment will be~     followed by a 12 week follow up.~   "
79907|NCT02011503|"~     The overall objective of this study is to evaluate the effectiveness of dehydrated human~     amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with~     venous leg ulcers (VLUs).~   "
79908|NCT02011490|"~     The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg~     intravenous (IV) dose of sugammadex in participants with moderate and severe renal~     insufficiency compared to that in participants with normal renal function. The study~     consists of two parts. In Part 1, participants with renal insufficiency and healthy~     participants will be administered study drug by IV bolus injection into a peripheral vein.~     In Part 2, participants with renal insufficiency and healthy participants will be~     administered study drug as an IV bolus into a peripheral vein, through an IV catheter~     connected to IV tubing with injection port. Subjects who participate in Part 1 of study may~     be enrolled in Part 2, which would reduce the overall number of participants enrolled for~     the study.~   "
79909|NCT02011477|"~     The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of~     neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural~     stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.~   "
79910|NCT02011464|"~     Pain control after knee replacement requires analgesia to both the top (anterior) and bottom~     (posterior) portion of the the knee. Presently we use a nerve block for the anterior~     portion. The investigators want to to examine if giving Exparel into the posterior portion~     will give better pain relief.~      Hypothesis: There is no difference in, the use of analgesics or the length and quality of~     analgesia and no decrease in the time to be able to accomplish simple to complex knee~     movements using Exparel infiltration when compared to controls.~   "
79911|NCT02011451|"~     The hypothesis is that 95% pure EGCG can protect brain cells in patients with Multiple~     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate~     (a chemical that reflects the number of neurons and their metabolism) over one six between~     people with MS treated with EGCG at a dose of 400mg twice a day and people with MS treated~     with a matching sugar pill.~   "
79952|NCT02010918|"~     The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg~     Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate~     Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee~     Osteoarthritis.~   "
79953|NCT02010905|"~     Rationale: The prevalence of adult patients with congenital heart disease (CHD) has steadily~     increased over the last decades, due to the advances in cardiac surgery. A large number of~     these patients cope with right ventricular (RV) volume or pressure overload, largely caused~     by residual lesions after cardiac surgery in childhood. Previous RV overload due to~     pulmonary regurgitation in Tetralogy of Fallot (TOF) can lead to RV dysfunction. These~     findings warrant close surveillance of RV function, and adequate and evidence-based~     pharmacological therapy to reduce both morbidity and mortality in this young patient group.~     The renin-angiotensin-aldosterone system (RAAS) is activated in patients with ventricular~     failure, irrespective of the effected (left or right) ventricle. Angiotensin converting~     enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB's) are drugs which act as~     inhibitors of RAAS. Previously, large trials have demonstrated the beneficial effect of~     angiotensin converting enzyme (ACE) inhibitors on morbidity and mortality in patients with~     acquired left ventricular (LV) dysfunction. ARB's have a similar effect as ACE inhibitors in~     patients with acquired LV dysfunction but discontinuation because of side effects such as~     cough is less frequent. In TOF patients with RV overload due to pulmonary regurgitation,~     pulmonary valve replacement leads to a decrease in RV size and pulmonary regurgitation.~     Current guidelines advise empiric use of RAAS inhibitors for right ventricular dysfunction~     in adult patients with congenital heart disease. However, the actual effect of RAAS~     inhibition on right ventricular dysfunction in adult TOF patients without severe valvular~     lesions has not been sufficiently investigated. Therefore, we set-up the proposed study, and~     hypothesize that ARB's have a beneficial effect on RV ejection fraction in adult TOF~     patients with RV dysfunction without severe valvular lesions.~      Objective: to improve RV ejection fraction in adult TOF patients with RV dysfunction without~     severe valvular lesions.~      Study design: a prospective, multicenter, double-blind, randomized, placebo-controlled~     trial. Follow up two years Study population: adult patients with Tetralogy of Fallot with~     right ventricular dysfunction, defined as right ventricular ejection fraction < 50% and~     without severe valvular lesions Intervention: patients are randomized to receive either~     losartan 150 mg once daily, or placebo in the same regimen. Main study parameters/endpoints:~     the primary endpoint is difference in change in RV ejection fraction, determined by~     cardiovascular magnetic resonance imaging (CMR), between the treatment and the control group~     at two years follow-up.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All investigations, except blood analysis, are non-invasive and free of risk.~     The burden for the patients mainly consists of the time that is consumed by the visits to~     the clinic. At these visits time will be consumed by: history taking and physical~     investigation (15 minutes); quality of life score (15 minutes); laboratory tests (6 times~     venopuncture, total amount of blood withdrawn approximately 90ml). Cardiopulmonary exercise~     testing (1hour), echocardiography (15 minutes) and CMR (45 minutes) are part of regular~     medical care. Adverse effects from losartan are usually limited and consist of dizziness due~     to hypotension, renal impairment, hyperkalemia and liver impairment. We expect no change or~     an increase in RV function in the intervention group compared to the control group over the~     two-year follow up period, which would be a great benefit for this young study population.~   "
79979|NCT02010567|"~     This trial will enroll patients with locally advanced rectal cancer (resectable and~     non-resectable).The phase Ib dose escalation portion of trial is designed to determine the~     maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies~     capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP)~     formulation of camptothecin. These results will determine the recommended phase II dose~     (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to~     evaluate the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and~     radiation therapy prior to surgery.~   "
79912|NCT02011438|"~     Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and~     impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both~     social anxiety and depression in adolescents; it includes relational (e.g., social~     exclusion) and reputational (e.g., spreading rumors) forms of peer victimization. Currently,~     there are no preventive interventions for adolescent SAD. Also, effective preventive~     interventions for adolescents have not yet integrated a focus on both social anxiety and~     depression or targeted specific peer risk factors. Interventions for depression and for~     bullying have not addressed IPV, which is less observable than overt victimization (e.g.,~     threats, physical acts).~      Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an~     integrated approach to reducing risk for SAD and depression by modifying and adapting an~     evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills~     Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We~     will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for~     handling challenging peer experiences. PEERS/UTalk will have a positive focus and will~     target adolescents who report elevated symptoms of social anxiety and/or depression and high~     levels of IPV.~      Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial:~      Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial~     of PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 high-risk~     adolescents.~      Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates~     of participation and study completion, (b) intervention credibility via adolescents' ratings~     of acceptability and satisfaction, and (c) high rates of clinician fidelity to the~     respective manuals.~      Hypothesis 2: Adolescents randomized to PEERS/UTalk will show improvements in primary~     outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician~     ratings) relative to those in the ES condition.~      Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes~     of increased quality of close friendships, increased peer support.~      Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk~     intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential~     moderators of response to the PEERS/UTalk intervention, recognizing that there are power~     limitations in doing so.~   "
79913|NCT02011425|"~     Previous studies have shown that contractions of the jaw-closing masseter muscle (MAS) often~     occur shortly after respiratory events during sleep in obstructive sleep apnea (OSA)~     patients. Although it has been hypothesized that such non-specific motor activations may~     contribute to restoration of a compromised upper airway during respiratory events, proper~     physiological understanding of MAS contractions in patients with OSA is lacking. MAS~     contractions are usually associated with the termination of respiratory events, but these~     contractions do not always occur after respiratory events. Therefore, the above-stated~     hypothesis that non-specific motor activations of the jaw-closing masseter muscle (MAS) may~     contribute to restoration of a compromised upper airway during respiratory events is not~     accepted yet. Further, Kato et al. concluded from a recent study that MAS contraction is an~     orofacial manifestation of a general motor reaction to arousal occurring during sleep in OSA~     patients. This suggests that MAS contraction after a respiratory event is dependent on the~     arousal response rather than on the respiratory events per se.~   "
79914|NCT02011412|"~     The investigators hypothesize that a risk score composed of age, sex, and the components of~     commonly ordered laboratory panels will be predictive of mortality in trauma patients, and~     will help improve clinicians' ability to make more accurate mortality predictions at the~     time of admission.~   "
79915|NCT02011399|"~     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for~     controlling electronic devices using only brain signals.~      The Mu rhythm is a naturally occuring wave produced by the brain. This research project will~     determine how to best train subjects to use the Mu rhythm for computer control.~   "
79916|NCT02011386|"~     The study investigates different criteria for remission based on MRI and circulating~     biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with~     axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates~     factors that affect disease activity, function and participation by use of different~     questionnaires.~   "
79917|NCT02011373|"~     Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but~     incurs problems of tolerance of implanted material. As an alternative to stapling and~     suturing, which cause vaginal erosion, we present a fixation technique using a sterile~     synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will~     assess efficacy in terms of 12-month failure of prolapse correction.~   "
79918|NCT02011360|"~     The overall objective is to explore the mechanisms by which macronutrients regulate food~     intake and weight gain in Prader Willi Syndrome (PWS).~      Previous studies from the investigators' labs suggest that the increased appetite of PWS may~     be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating~     hormone produced primarily by the stomach. This study will compare the effects of low~     carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones~     and markers of insulin sensitivity in patients with PWS.~      The investigators hypothesize that the low carbohydrate diet will suppress plasma active~     ghrelin and increase appetite-suppressing hormones to a greater degree and for longer~     duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The~     investigators also hypothesize that the low carb diet will improve hormonal and metabolic~     markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory~     cytokine profiles of children with PWS.~   "
79919|NCT02011347|"~     The objective is to evaluate the sparing effect of ketamine on the dose of propofol.~   "
79920|NCT02011334|"~     This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and~     efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease~     modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America~     with an inadequate response to non-biologic DMARDs.~   "
79921|NCT02011321|"~     Vasospasm occurs frequently after aneurysmal subarachnoid hemorrhage and can lead to~     strokes. The investigators will investigate if infusion of a novel drug, clevidipine, will~     decrease vasospasm during the infusion and post infusion period using transcranial doppler~     monitoring of patients with subarachnoid hemorrhage and moderate severity vasospasm~   "
79922|NCT02011308|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporisation of the Prostate) compared to TUR-P.~   "
79923|NCT02011295|"~     The purpose of this study is to determine the clinical efficacy of the application of bone~     marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of~     osteochondral lesions of the talus (OLTs).~   "
79972|NCT02010658|"~     The objective of this prospective randomized trial is to ascertain whether the use of a~     cognitive aid improves adherence to best published practices for the management of simulated~     patients regarding perioperative cardiac evaluation and management.~   "
79973|NCT02010645|"~     The goal of this clinical research study is to learn if eltrombopag given in combination~     with decitabine can help to control advanced MDS. The safety of this study drug combination~     will also be studied.~   "
79924|NCT02011282|"~     We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in~     critical care patients, can decrease the impact or severity of the critical illness myopathy~     (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect~     the incidence density rate of nosocomial pneumonia in the ICU.~      Patients will be divided into two groups, Group A and Group B chosen at random. In Group A~     conventional physiotherapy will be applied while in Group B, ENMS will also be applied~     additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will~     be 1 hour, it will be applied before the start of the physiotherapy per day of~     hospitalization and for 10 days in each patient.~      The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will~     undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori~     Trichrome will be used to determine the existence or absence of myopathy. In addition the~     ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3),~     thus achieving a separation of myopathy and neuropathy.~      The primary outcome of the study will be the incidence of myopathy in both groups, at day~     12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing~     this rate by 50% in the intervention group using statistical power equal to 0.80 up to a~     level of p <0.05, 12 number of patients will be required in each group.~   "
79925|NCT02011269|"~     This is a randomized, blinded, multicenter study to assess the safety and treatment effect~     of 12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic~     plaque psoriasis.~   "
79926|NCT02011256|"~     The purpose of this study is to determine the frequency of atrial fibrillation in patients~     with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm~     extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder.~     Furthermore, the patients will be examined with echocardiography, coronary calcium-score and~     biomarkers with the purpose to predict which subjects at risk for developing atrial~     fibrillation.~   "
79927|NCT02011243|"~     The main objective of this study is to estimate the incidence and prevalence of Internal~     Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position~     2) strictly greater than 20 ° in a population of advanced-level handball players over a~     training season.~   "
79928|NCT02011230|"~     Pain after tonsillectomy remains a key barrier during the post operative period. The~     published return rate to the emergency department for hydration and pain control is~     approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency~     department post tonsillectomy, patient experiences will be improved and health care dollars~     spent will be decreased. We will attempt to improve hydration status by encouraging~     consumption of a novel isotonic hydration solution that is currently commercially available.~      Our study hypothesis is that patients provided an isotonic hydration solution and~     instructions on avoiding dehydration post operatively will have improved pain control and~     decreased emergency department visits.~      Improvement in hydration status has the potential of decreasing emergency room visits and~     subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative~     hydration may include decrease in pain and decrease in post-operative bleeding rates.~      A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently~     become commercially available. Itis very similar to that of Pedialyte, a commonly used~     rehydration solution. Pedialyte was designed for rehydration of infants and small children.~     It has a taste that is not acceptable to many adults and older children.~      This study will implement the use of Hoist as suitable rehydration solution. This study is~     designed to define the relationship between improvement of patient's hydration through~     provision of a rehydration solution during the post operative period and decrease in~     complications requiring return to the emergency room, including dehydration and bleeding, as~     well as improvement in overall pain control.~   "
79929|NCT02011217|"~     The aim of this study is to contribute to a better understanding of how dietary fibre in rye~     affects appetite and metabolic processes. We will evaluate how the intake of rye crisp~     breads affects appetite, insulin secretion and glucose levels in the blood in healthy~     humans. We will also investigate microstructural properties of the crisp breads with~     microscopy, as well as to characterize the food products with respect to the content of~     dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how~     observed effects on appetite are related to changes in insulin and glucose levels, appetite~     related hormonal signals and microstructural properties to verify findings from previous~     studies.~   "
79930|NCT02011204|"~     This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The~     trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular~     diseases, and healthy volunteers to see if the EIM device can measure disease in muscle~     tissue.~   "
79931|NCT02011191|"~     Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage~     renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with~     RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the~     relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of~     biotin deficiency in those with and without RLS (Study 1) and to determine the effect of~     biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due~     to ESRD.~   "
79974|NCT02010632|"~     The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the~     platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid~     metabolite between generic and reference clopidogrel products in Thai healthy volunteers~   "
79975|NCT02010619|"~     To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment~     when compared to a control group consisting of supportive therapy.~   "
79980|NCT02010554|"~     Between 15-20% of MS patients decide not to initiate disease modifying therapies after being~     diagnosed with MS. For this study, we will develop a telephone-based talk therapy~     intervention and then conduct a randomized controlled trial. Patients will be assigned to~     either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control~     condition. We hypothesize that patients undergoing phone therapy will be more likely to~     indicate they are interested in initiating disease modifying medications than patients given~     brief education and treatment as usual.~   "
94480|NCT01820637|"~     To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable~     performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal~     Artery (PPA) lesions.~   "
79932|NCT02011178|"~     Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney~     failure,heart disease and premature death. Unfortunately, the best medical therapies~     available for DKD today are ultimately unable to prevent its progression, especially in~     obese patients.Surgical rerouting of food within the gut with a gastric bypass operation~     (RYGB), improves diabetes and some of its complications.~      The investigators propose to investigate whether RYGB in combination with best medical~     therapy in patients with DKD and obesity prevent further deterioration of kidney function~     over a 3 years follow up period.~      Study design: This is an international collaboration with leading centres in Sweden and~     Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer~     to be randomly assigned to receive best medical therapy with RYGB or best medical therapy~     without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney~     function. Yearly measurements of kidney function will then be done over a period of 3 years~     as a primary outcome to determine whether differences in DKD can be detectable. The study~     will also examine and compare a) safety of the interventions, b) the health economic impact~     on direct healthcare costs and Quality of Life in patients as well as c) the value of a new~     marker of DKD in determining which patients are most likely to benefit from surgery.~      Overall the study will strengthen the evidence base guiding clinical decisions about the~     usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD~     in patients with obesity and diabetes.~   "
79933|NCT02011165|"~     The macular hole formation takes place in the centre of the retina. A closure of the macular~     hole is believed to take place if the central retinal area is kept dry in the postoperative~     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the~     supine position in the first postoperative days. The investigators use the tennis ball~     technique where a tennis ball is fastened in the back of the night shirt in order to help~     patients compliance in avoiding the supine sleeping position. The investigators have~     developed a positioning measuring device which can measure the extent of supine positioning~     time. Patients are to sleep two nights with the positioning measuring device, one night with~     a tennis ball in the back of the night shirt and one night without. Hereby the investigators~     search new knowledge concerning patients compliance and verification of the tennis ball~     technique.~   "
79934|NCT02011152|"~     The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate~     during spinal anesthesia on duration of spinal block and postoperative pain.~   "
79935|NCT02011139|"~     Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on~     the quality of life, functional ability, and mortality, with a prevalence rate as high as~     20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has~     been little data so far particularly in terms of randomized clinical trials. Here, we~     investigate the effect of cognitive-behavioral group therapy for enhancing mental health and~     quality of life in patients with ESRD.~   "
79936|NCT02011126|"~     This phase II trial studies the side effects and how well imetelstat sodium works in~     treating younger patients with relapsed or refractory solid tumors. Imetelstat sodium may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
79937|NCT02011113|"~     The purpose of this study is to evaluate the efficacy and safety of pomalidomide in~     combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.~   "
79938|NCT02011100|"~     Carnosine is a naturally occurring compound with a potential health benefits. In animal~     studies, carnosine supplementation reduces manifestation of chronic civilization diseases,~     regulates subclinical inflammation, protein glycation and lipid & glucose metabolism. Our~     preliminary data showed the relationship between insulin resistance and carnosine content in~     human skeletal muscle. Based on these unique results we plan to perform intervention study~     aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might~     reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were~     associated with expression of specific miRNAs. Circulating miRNAs related to carnosine~     action are unknown. The putative positive effects of carnosine on insulin sensitivity and~     secretion in obese patients might have a tremendous impact in prevention of type 2 diabetes.~     Identification of miRNAs associated with carnosine action could provide predictors of~     successful therapy.~   "
79939|NCT02011087|"~     This clinical trial studies bioelectrical impedance phase angle in predicting treatment~     outcome in patients with extensive stage small cell lung cancer receiving first-line~     chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help~     predict a patient's response to treatment for small cell lung cancer.~   "
79940|NCT02011074|"~     Preoperative anxiety can be detected via structured and standardised screening by the State~     - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The~     investigators evaluate the relation of perioperative anxiety and heart rate variability,~     also the impact of general anesthesia on the change of heart rate variability.~   "
79941|NCT02011061|"~     Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed~     tomography angiography (CCTA). A novel approach to potentially overcome this limitation is~     coronary calcium subtraction.~      The primary hypothesis of the study is:~      - Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to~     conventional CCTA on a per-patient basis~   "
79976|NCT02010606|"~     The purpose of this study is to test the safety and effects of a special type of a cancer~     vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or~     recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's~     own immune system against their tumor. This study utilizes a patient's own~     immune-stimulating dendritic cells that are isolated in a procedure called leukapheresis. In~     a laboratory, these dendritic cells are treated in a way that is designed to promote an~     immune response against cancer stem cells. Then the dendritic cells are injected under the~     skin in a series of vaccinations, with the goal of activating an immune response against~     cancer stem cells in the tumor.~      To qualify for this study, patients must have very little to no residual tumor visible on a~     recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will~     receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent~     glioblastoma will not receive any treatment other than the vaccines as long as they are~     participating in this study, unless they were previously treated with bevacizumab, in which~     case they will be allowed to continue receiving bevacizumab.~   "
79942|NCT02011048|"~     One of five patients undergoing open abdominal surgery develops an abdominal wall defect~     (incisional hernia) as a late complication. A fraction of these are giant hernia with a~     fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical~     treatment is complex.~      Correction of giant incisional hernias including a relatively new and minimally invasive~     technique, (endoscopic components separation) offers promising results. This procedure~     allows the abdominal muscles to be joined centrally restoring the integrity of the abdominal~     wall.~      The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital~     allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers~     to define the functional and biophysical outcome from hernia repair. We hypothesize that the~     abdominal muscle function is significantly optimized after restoration of the abdominal wall~     using this technique, and that muscular function is crucial for the postoperative quality of~     life. Moreover, we want to assess whether this operation specifically optimizes the function~     and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung~     function. Finally, we will investigate if the patients with giant incisional hernia may be~     identified by an altered composition of their connective tissue as compared with patients~     who do not develop incisional hernia.~      This is a prospective study of two patient groups: 1) Patients with a giant incisional~     hernia and 2) controls undergoing open surgery on other indications. Assessment is done pre-~     and perioperatively and after 1 year including muscular function, lung function, abdominal~     wall anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles~     and connective tissue are examined for muscle fiber size/type and structure by various~     methods, including electron microscopy and atomic force microscopy. Lung function is~     monitored by blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test~     questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student~     Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen,~     professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.~   "
79943|NCT02011035|"~     This study is designed to test the safety and efficacy of Colflex, an oral spray created by~     Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and~     sore throats, as well as dental and oral health changes.~   "
79944|NCT02011022|"~     * The pharmacokinetics of MTX were assessed with regards to the relevance of several~     different patient specific factors in 291 pediatric patients, who were administered with~     high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using~     nonlinear mixed effects modeling.~   "
79945|NCT02011009|"~     Bacterial resistance to antibiotics is a major public health problem. The epidemiology of~     enteric bacteria including E. coli is changing rapidly with the global spread of a~     resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for~     resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for~     Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.~      The main phenomena causing this problem are:~        -  The selection pressure by antibiotics, in their use in humans or animals~        -  The hand transmission via the digestive reservoir (faeces)~        -  Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic~          support (plasmid)~      In this context, we decided to implement a cross-border study to improve and accelerate the~     management, diagnosis and treatment of patients with ESBL in close collaboration between~     medical and paramedical staff in hospitals, laboratories and private medical offices.~      The objective of this study is to standardize diagnostic and therapeutic measures allowing a~     better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in~     the PACA region and Liguria by providing a tool : The Kit ESBL.~      The  ESBL ToolKIT (also translated into Italian) includes:~        -  Information on epidemiological data~        -  A checklist edited for extra-hospital use (private practitioners, health care units~          other than hospitals)~        -  A checklist edited for hospital use~        -  A leaflet BMR for the patient explaining the problematic as well as hygiene measures~        -  Therapeutical protocols for hospital use and extra hospital use~        -  An sample letter for the attending physician~      The objective of this prospective multicenter cohort study is to evaluate the use of this~     kit, and to measure its impact on:~        -  The prescription of appropriate antibiotics~        -  The measures taken to prevent man to man transmission~        -  The quality of information provided to the patient~      In this context we are also performing a multicentre prospective interventional cohort of~     HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum~     ß-lacatamase-producing bacteria) carriers.~      We will also try to determine if other sexually transmitted infections associated (syphilis,~     gonorrhea and chlamydia) are contributing factors to ESBL carriage.~      So far there is no data documented on ESBL-carriage in a population of HIV-positive~     patients.~   "
79946|NCT02010996|"~     The great saphenous vein is the most commonly used material in coronary vascular bridging~     operation. Coronary bypass operation to obtain the great saphenous vein is mainly through~     the incision open groin to ankle. This operation may damage the lymphatic, cause lymph~     circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around~     hematoma and other a series of symptoms.Based on some studies and our experience that vacuum~     assisted closure （VAC）is effective in complex wound failures following Stripping saphenous~     vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary~     bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC~     application on postoperative complications and wound healing after Stripping saphenous vein~     in Coronary bypass in comparison to conventional suction drain.~   "
79947|NCT02010983|"~     Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell~     carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier~     dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed.~     Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The~     aim of this study was therefore to evaluate a screening program using chromoendoscopy with~     Lugol to detect dysplasia in patients with idiopathic achalasia.~      A second objective is to study the relationship between foodstasis and the development op~     dysplasia~   "
79948|NCT02010970|"~     This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction~     study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on~     the single-dose PK of AZD3293 and the effects of coadministration of single- and~     multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the~     safety and tolerability of single and multiple oral doses of AZD3293, alone and in~     combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is~     being developed for the treatment of Alzheimer's disease~   "
79949|NCT02010957|"~     Adrenal masses are highly prevalent and detected with high frequency by conventional~     imaging. Conventional imaging often fails to rule out a malignant lesion. Accordingly, most~     hormonally inactive adrenal masses removed by surgery are benign adenomas for which surgical~     removal is unnecessary and poses an avoidable risk to the patients. We hypothesize that the~     combination of FDG-PET and 123I-Iodometomidate imaging has the potential to noninvasively~     identify benign adrenocortical adenomas with high accuracy, thereby avoiding unnecessary~     surgery. Uptake of 123I-Iodometomidate by the adrenal mass demonstrates the presence of CYP~     11B enzymes which specifically bind metomidate with high avidity establishing the~     adrenocortical origin of the lesion, while low uptake of FDG-PET in an adrenocortical lesion~     establishes its benign nature and excludes the presence of adrenocortical cancer (ACC). The~     proposed trial will assess the sensitivity, specificity, positive and negative predictive~     value of the combined imaging for the diagnosis of adrenocortical adenoma. A secondary focus~     is on the performance of the combined test for differentiating ACC from non-ACC lesions. We~     expect that the results of our trial will help to greatly reduce the need for surgery in~     hormonally inactive adrenal masses.~   "
79977|NCT02010593|"~     This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4~     weeks in postmenopausal women over 12 weeks of product use.~   "
79954|NCT02010892|"~     This is a prospective observational cohort study that will collect data from the point of~     referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years).~     The data collected will allow estimation of the success of any intervention (in terms of~     reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks~     associated with the three procedures. Clinical outcomes in the three treatment groups will~     be described.~      Aims~      We aim to answer the following questions:~        1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is~          the risk of aneurysm growth, dissection, rupture, permanent neurological injury or~          death? What is the effect on quality of life (QoL)?~        2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what~          is the risk of growth, dissection, rupture, permanent neurological injury or death?~        3. How does QoL change from pre- to post intervention?~        4. Can aneurysm or patient related predictors of good/poor treatment outcomes be~          determined?~        5. What is the most cost-effective strategy in:~             1. Patients eligible for either ESG or OSR?~             2. Patients eligible for either ESG or best medical therapy (BMT)?~             3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?~        6. What further research is required? What would be the most important research to pursue?~   "
79955|NCT02010879|"~     Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses,~     there is lack of data on the function of platelets in ductal closure. Information on~     functions of platelets in ductal closure may change the known model for ductus arterioses~     and may affect the treatment modalities.~   "
79956|NCT02010866|"~     The purpose of this study is to study whether distressed medical residents, fellows, and~     faculty health professionals benefit from completing online an anonymous and interactive~     screening of stress, depression, substance use, and suicidal thoughts. The screening and~     ability to interact online with a clinician anonymously are hypothesized to increase~     willingness to come for counseling in person. Suicide risk factors are expected to be lower~     once the distressed medical trainee or faculty member receives treatment.~   "
79957|NCT02010853|"~     The transient global amnesia, in which the memory disorder is massive, transient and pure,~     offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and~     selective lesion located on the CA1 region of the hippocampus better visible between 48h and~     72h after onset of the episode.~      There is therefore a real dissociation between structural lesions witch are minimal or~     non-existent and the massive memory disorder. This suggests that functional impairment goes~     far beyond the structural damage in this condition. To our knowledge, no study has been~     performed to identify this functional impairment using resting state fMRI.~      Thus, investigators wish to study the neural networks involved in memory impairment during~     the acute phase of transient global amnesia using resting state imaging. This technique~     appears to be modern and adapted to these patients population. Investigators hypothesize~     that despite limited structural lesions, a large functional network is impaired compared to~     that observed in a group of healthy subjects. investigators believe that the alteration of~     the functional network will explain the depth of memory impairment observed.~      The main aim of this study will be to identify functional impairment in the patient group~     vs. control group during the acute phase of transient global amnesia (TGA) using resting~     state imaging.~      Patients potentially eligible will be informed during their arrival to the emergency unit.~     If the patient is eligible and would like to participate, information will be given. For the~     patients willing to participate, inclusion and exclusion criteria will be verified. Two~     imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment~     will be performed during three visits.~   "
79958|NCT02010840|"~     Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation~     program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital~     relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year~     postpartum than those who receive the usual perinatal care.~   "
79959|NCT02010827|"~     We want to investigate how lack of glucagon suppression during an oral glucose tolerance~     test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.~   "
79960|NCT02010814|"~     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS~     is characterized by increase levels of testosterone, unwanted hair growth, adiposity,~     irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and~     cardiovascular diseases. Women with PCOS are reported to have increased levels of stress~     hormones, which may be associated with decreased quality of life. Increased testosterone~     levels in women may decrease the risk of osteoporosis. The aim of the present study is to~     measure levels of stress hormones in urine and describe quality of life using~     questionnaires. In addition we aim to characterize body composition and bone architecture~     using DXA and ExtremeCT.~      As part of the project, a Biobank with fasting blood samples from participants is~     established.~   "
79978|NCT02010580|"~     Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene~     (Osphena, Shionogi, Florham, NJ) or placebo tablet. Placebo tablets will be identical in~     appearance and packaging will be identical for the two pills. The participants will be~     instructed to take one tablet in the morning with food for twelve weeks. Basic demographic~     information will be obtained on all participants. All women will undergo a pelvic~     examination, and questionnaires regarding pelvic floor dysfunction and sexual function~     before and three months after treatment. 3-D ultrasound with Doppler blood flow analysis~     will be performed before the patient is started on the treatment. 3 months after treatment,~     the 3-D ultrasound with Doppler blood flow analysis will be repeated. Four areas will be~     measured:~        1. The urethra in exactly the same section at the same level with the same setups.~        2. 3 and 9 O'clock position~        3. 6 o'clock position~        4. Clitoral blood flow Doppler blood flow will be visualized using the Doppler color mode~          of the ultrasound machine and will be applied for the assessment of the vascularity~          pattern. Additionally, we will record a film with the use of Color Doppler in a video~          file. The transducer will be immobilized at one selected section and record a ten~          seconds of film. This film will be further analyzed in special software called Pixel~          flux after the examination. Dr. Pawel Wieczorek and Dr. Magdalena Wozniak will read~          these deidentified video files in a randomized fashion based on their previous research~          experience with similar video interpretations of pelvic color Doppler imaging [8-11].~   "
79961|NCT02010801|"~     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers~     is one the most common malignancies in the world. Over 10000 new cases per year are~     diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains~     dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70%to~     85%) of patients present with advanced or unresectable disease. In contrast, small liver~     cancers can be cured with an appreciable frequency. Five-year disease-free survival~     exceeding 50% has been reported for surgical resection, and for the inoperable patients who~     do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is~     recommended as an alternative curative therapy. However, the main drawback of RFA is its~     limitation to tumor size and location. The tumors larger than 5 cm in diameter or located~     adjacent to vessels, could not be ablated completely.~      Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can~     ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor~     effect does not result from thermotherapy, so is also not diminished by adjacent vessels.~     Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment~     for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010.~     However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study,~     the investigators will perform intraoperative IRE for the patients with liver cancers who~     are scheduled to receive hepatectomy in our hospital, and the investigators will evaluate~     the ablate effect of tumors on specimens, and the effect of adjacent vessels. The~     investigators will appraisal the clinical feasibility and advantage of the system by this~     study.~   "
79962|NCT02010788|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic~     detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by~     anticholinergic drugs.~   "
79963|NCT02010775|"~     This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type~     A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).~   "
79964|NCT02010762|"~     The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection.~     Postoperative recurrence of the disease is virtually inevitable and continues to be one of~     the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments~     to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents~     appear promising but are hampered by immunogenicity, side effects and high cost.~      Vitamin D has recently received a lot of scientific attention and was found to have strong~     anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients~     appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in~     medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally~     missed its endpoint because of lack of power.~      The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in~     the prevention of postoperative recurrence.~   "
79965|NCT02010749|"~     The primary objective of the study was to compare the growth parameters of children~     approximately 2* years of age, who as infants were randomized to receive either a~     lower-protein formula (experimental formula; EF) with 12.8 g/L protein or a standard~     formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of~     life. The secondary objective was to describe diet and nutrient intake in this cohort of~     children. The exploratory objectives were to describe stool microbiota in a subset of this~     cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and~     minerals) in a second subset of this cohort.~      (* The mean age of subjects was 33.0 months due to a delay in the study start-up.)~   "
79966|NCT02010736|"~     The purpose of this study is to observe the behavior of kinematic variables in children with~     spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with~     ankle loading.~      The children underwent a single treadmill training session with ankle loading. The kinematic~     parameters were assessed in three phases: before training (PRE); immediately after training~     (POST); and 5 minutes after the end of training (FOLLOW UP).~      The investigators hypothesized that the treadmill gait training with additional lower limb~     loading would be a disturbance capable of modifying the locomotor strategy of children with~     SHCP, by the increase in kinematic parameters in the swing phase of gait.~   "
79967|NCT02010723|"~     The purpose of this study is to compare two therapeutic procedures in the treatment of~     isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and~     avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.~   "
79968|NCT02010710|"~     In women judged to require continuous electronic fetal heart rate monitoring (EFM) during~     their labour, does the addition of decision support software to aid the interpretation of~     the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This~     study is not introducing a new form of labour monitoring; it is evaluating the addition of~     decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: No~     decision-support - CTGs with no additional interpretation (UK standard care), compared~     with: Decision-support - CTGs with the decision support software running that will alert~     clinicians to the presence of abnormalities in the CTG in real time. How the labour is~     managed is entirely up to the recruiting unit and the woman; however the allocation of~     decision-support or no decision-support is determined randomly by the Guardian™ system.~   "
79969|NCT02010697|"~     This study examines whether nonsmokers can be mobilized to help smokers quit. We will test,~     via mail campaign, whether targeting nonsmokers can be equally effective in increasing~     smokers' quit rate as targeting smokers directly. The hypothesis is that both targeted~     interventions will lead to a higher quit rate than a control group, which receives one set~     of self-help materials. Each of the targeted intervention groups receives 10 mailings.~     Smoking status of all three groups will be measured at 3 and 7 months post randomization.~   "
79970|NCT02010684|"~     In this project, investigators examine the impact of a mood treatment enhanced diabetes~     self-care intervention for depressed, low-income Latino diabetics. The investigators~     hypothesize that the mood treatment enhancement will lead to significant improvement in both~     diabetes and depression outcomes as compared with the self-care intervention alone.~   "
79971|NCT02010671|"~     We are surveying women who have had a previous cesarean section at the time of entry into~     prenatal care for their next pregnancy about their thoughts related to a trial of labor~     after cesarean (TOLAC) or repeat c-section.~   "
79982|NCT02010528|"~     Parents have an important role in child's diabetes management. Many studies show that~     parental psychological stress and family dynamics are associated with parental~     diabetes-related distress and treatment outcomes among children and adolescents with type 1~     diabetes.~      The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and~     fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life,~     positive and negative affect and adult attachment relationship pattern), family hardiness~     and characteristics of children with type 1 diabetes in a sample of mothers and fathers of~     children and adolescents with type 1 diabetes of ages up to 18 years.~      In this study it is hypothesized that:~        1. greater parental fear of hypoglycemia and diabetes-related burden are associated with~          lower family hardiness and worse psychological well-being parents and higher HbA1c~          levels in children and adolescents with type 1 diabetes;~        2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower~          psychological well-being comparing to fathers.~        3. parents of children and adolescents with type 1diabetes will report greater anxiety,~          lower psychological well-being and family hardiness comparing to parents of children~          without diabetes.~      Standardized and validated questionnaires will be used to determine: parental fear of~     hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being,~     adult attachment relationship pattern and family hardiness.~      The investigators will also measure parent daily involvement in child's diabetes management,~     frequency of blood glucose monitoring and parent general satisfaction with glycemic control.~     Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode~     will also be obtained. These measures will be correlated with other research variables.~   "
79983|NCT02010515|"~     This prospective single-center study is an observational risk stratification trial in about~     250 patients with standard indications for ICD treatment.~      Implantable cardioverter defibrillators (ICD) have been shown to improve survival and~     current guidelines recommend their use for primary and secondary prevention of sudden~     cardiac death (SCD). However, a large number of patients never receive an appropriate~     therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in~     other patients.~      Thus, identification of predictors for survival or ICD shocks is necessary for improved~     patient selection and optimized therapeutic strategies.~      Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave~     alternans (TWA) and Holter ECG including premature ventricular contractions (PVC),~     non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and~     deceleration capacity, as well as clinical variables is possible, but not implemented in~     clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD~     for primary or secondary prevention of SCD following current guidelines.~      Patients will be prospectively followed and the predictive value of the risk markers~     mentioned above to predict all-cause mortality or appropriate ICD shocks will be~     investigated.~   "
79984|NCT02010502|"~     To examine the effects of two forms of beetroot juice supplementation on exercise~     performance in trained cyclists.~   "
79985|NCT02010489|"~     BACKGROUND: Obesity is a global epidemic and Canada has one of the highest obesity rates in~     westernized countries. Obesity has many health related complications, including high blood~     pressure, high cholesterol, diabetes, sleep apnea and osteoarthritis. Bariatric surgery is~     the most effective way of achieving long-term weight loss and treating the complications of~     obesity. There is good evidence to support the relationship between physical activity and~     weight loss following bariatric surgery. While the period leading up to surgery is~     considered an important opportunity for lifestyle modification, evidence to support~     recommendations for a supervised preoperative exercise intervention is lacking.~      OBJECTIVES: The objective of this study is to measure the short and intermediate-term~     benefits of a preoperative exercise intervention on patients awaiting publicly funded~     bariatric surgery in Manitoba. The primary outcome will be improvement in general exercise~     capacity as measured by change in 6-minute walk test (how far a person can walk on a flat~     surface in 6 minutes). Other outcomes will include excess weight loss, change in body~     composition, strength testing and irisin bloodwork & muscle biopsy.~      HYPOTHESIS: It is hypothesized that preoperative exercise will result in improved exercise~     capacity and general fitness in the short and intermediate-term post-bariatric surgery.~      METHODS: Patients who are awaiting publicly funded bariatric surgery in Manitoba will be~     offered the opportunity to participate in a randomized study between usual preoperative care~     (n=35) and usual care plus a supervised exercise program (n=35). Usual care will involve~     multidisciplinary evaluation and preoperative counseling with a kinesiologist. In the~     intervention group, patients will participate in a 12-week supervised exercise program at~     the Reh-fit Centre.~      RESULTS: The study will determine the short and intermediate-term benefits of a preoperative~     exercise intervention on general fitness and exercise capacity as well as weight loss~     post-bariatric surgery. It is an important opportunity for collaboration between a~     multidisciplinary health care team and a medically-certified community fitness centre.~     Currently there are approximately 200 patients undergoing public bariatric surgery annually~     in Manitoba. If this study demonstrates a benefit to preoperative exercise, the results will~     be used to support an application to Manitoba Health for routine implementation of a similar~     intervention for all patients awaiting publicly funded bariatric surgery. It will also be~     used to support an application for a larger multi-institutional study of preoperative~     exercise at several Canadian bariatric centres.~   "
79986|NCT02010476|"~     Type 2 diabetes mellitus has been associated with an about 2-fold increase in risk of~     Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin~     sensitivity. It may be hypothesized that, compared to insulin sensitive subjects otherwise~     similar in general health and body habitus, insulin resistant subjects are more likely to~     have cerebrospinal fluid (CSF) indicators of incipient AD pathology, abnormalities in CSF~     peptides related to insulin signaling and glucose homeostasis, and possibly other~     metabolites that are associated with a risk of AD. The objective of this study is to examine~     the relation of insulin resistance and the concentrations of CSF biomarkers. The results of~     this study may be useful in the detection of the subjects who are at risk for cognitive~     decline and AD.~   "
79987|NCT02010463|"~     This study aims to support the hypothesis that brain processes underlying reward processing~     and impulse control contribute to obesity and to adherence in a new exercise regimen.~   "
79988|NCT02010450|"~     This study is a pilot study to test the effectiveness of incentive items to increase~     compliance of infant safe sleep practices among caregivers.~   "
79989|NCT02010437|"~     Leaking valves in the veins of the legs causes veins to become large and bloated. These~     swollen veins are called varicose veins and are a very common problem, affecting more than~     a third of all adults in the UK. Varicose veins reduce people's quality of life by causing~     problems such as pain, itching and restless legs. Varicose veins may also damage the skin~     over time causing problems such as bleeding, skin colour changes, eczema and even break-down~     in the skin which is called an ulcer. Newer, key-hole methods of treating leaky veins have~     been developed as an alternative to surgery and can be performed under local anaesthetic~     with the patient awake. Rather than cuts in the skin, these minimally invasive techniques~     are performed through tiny stab wounds; little larger than needle holes. The varicose vein~     is then destroyed from within, usually using heat to burn the inside of the vein. These~     procedures are popular; with a rapid recovery and a very high success rate. However these~     methods also require the vein to be surrounded by a large volume of dilute local anaesthetic~     which can to be slightly painful to administer. A technique called Foam sclerotherapy~     involves the injection of a drug which has been mixed into a foam. This goes into the vein~     and causes it to stick shut. This procedure is near painless to perform as very few, small~     local anaesthetic injections are required; however the chance for a successful treatment~     first time are lower and patients may need to return for repeat treatments to successfully~     treat the vein.~      The aim of this study is to see whether the success rates for this technique can be~     improved. One method catheter directed foam sclerotherapy involves the delivery of the~     foam through a catheter (a long very thin tube), so that large lengths of vein can be~     treated through a single hole. The final method ClariVein again uses a catheter; but this~     time the catheter has a small wire on the end which spins around inside the vein; similar to~     an edge strimmer in the garden; except it irritates the vein: rather than cutting it. This~     irritation makes the vein more susceptible to the drug which can again be applied directly~     to the vein wall whilst it is still active. Early results show that this final method is~     very successful; however the equipment is more expensive than for the other two.~      This study will randomly allocate willing participants with varicose veins to receive one of~     these three treatments to see whether the two newer treatments can improve the success rates~     and quality of life improvements seen with foam sclerotherapy, whilst also allowing near~     painless treatment, without significant complications, at an appropriate cost.~   "
80362|NCT02005549|"~     This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel~     and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin~     will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated~     time on study treatment is 3-12 months.~   "
79990|NCT02010424|"~     In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are~     cultured individually, however when bovine embryos are cultured in groups a typical 25-35%~     of blastocysts can be observed. This tendency, i.e. improved embryo development in group~     culture, has also been demonstrated in other mammalian species, such as mouse, cat and~     human. The main reason for this beneficial outcome of group culture has been ascribed to the~     presence of autocrine factors, which are factors secreted by preimplantation embryos that~     act upon the embryo itself or the neighboring embryos .~      Although group culture systems are common in in vitro production systems for animal embryos,~     it is rarely done in human settings, where individual follow-up of the embryo during the~     whole culture period is of utmost importance. Recently a CE-labelled culture device has been~     designed for human embryos, that allow to combine the benefits of both group culture~     approaches and individual culture. The WOW dish is commercially available by Primo Vision~     and consists of 9 small microwells on the bottom of the plate, so that the embryos can be~     cultivated individually in a microwell, but covered by the same drop of culture medium.~      In this clinical randomized trial, 158 patients will be included of which half of the~     fertilized oocytes will be cultured individually (standard culture system) and half of the~     fertilized oocytes will be cultured in group in a WOW dish, both during five days of~     culture. The aim of this study is to increase the number of blastocysts suitable for~     transfer or cryopreservation by culturing the embryos in WOW dishes.~   "
79991|NCT02010411|"~     The hypothesis being tested is that inhibition of the enzyme known as elastase in the~     airways of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1~     antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by~     aerosol therapy twice in 1 day and sputum will be collected to measure the density of~     bacteria~   "
79992|NCT02010398|"~     The purpose of this study is to determine whether, in patients with multiple sclerosis~     presenting with marked asymmetry of strength, training the less-affected limb with a~     Cross-Training approach may induce a meaningful transfer of strength with~     neurophysiological, functional and clinical correlates, to the contralateral, more-impaired~     limb.~   "
79993|NCT02010385|"~     Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric~     bypass (RYGB) surgery is currently the most effective. It results in long term weight loss~     maintenance, significant remission of obesity-related comorbidities and decreased overall~     mortality. It also induces changes in gastrointestinal hormones responses, with an increase~     of anorexigenic hormones GLP-1, and PYY.~      Although successful, the mechanisms for RYGB-induced weight loss are not completely~     understood. The RYGB does result in increased satiation, decreased calorie intake and~     decreased preferences for sweet and fatty foods. Previous work from our lab has shown using~     progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for~     sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive~     behaviour after the surgery remain unknown. They may be triggered by changes in gut~     hormones, conditioned taste aversion (negative post-ingestive effects) or changes in serum~     bile acids levels.~      This study aims to assess whether RGYB-induced gut hormone changes contribute to the~     decrease in appetitive behaviour for sweet and fatty foods observed after the surgery.~      This is a double blind controlled study comparing the effect of blocking gut hormones with~     somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be~     carried out. Appetitive behaviour will be measured using the progressive ratio task.~      The investigators hypothesize that blocking the gut hormones in obese patients with RYGB~     will increase their appetitive behaviour for sweet-fat candies.~   "
79994|NCT02010372|"~     The overall purpose of this study is to evaluate the use of features of the New York State~     Immunization Information System (NYSIIS) by various types of primary care practices and~     determine how best to promote the use of IIS features and functionality. The primary goal is~     to promote the use of NYSIIS for immunization quality improvement (QI) in the practice~     setting. Customized training sessions will be conducted by study staff to educate practices~     on NYSIIS' enhanced features.~   "
79995|NCT02010359|"~     This study is a clinical trial designed to assess whether fish oil treatments are effective~     in the prevention of obesity-related fat tissue (adipose) inflammation. Specifically it~     addresses the hypothesis that fish oils treatments will reduce signaling by chemokine~     pathways (fractalkine and MCP-1) important in adipose tissue for the recruitment and~     activation of certain white blood cells (macrophages). The study is a double-blind~     placebo-controlled trial of the fish oil Lovaza from GlaxoSmithKline (omega-3-acid ethyl~     esters; a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic~     acid (DHA)) in obese non-diabetic adults, to determine if Lovaza decreases markers of~     inflammation and macrophage activation in adipose and blood and understand the mechanism by~     which fish oils affect inflammation.~   "
79996|NCT02010346|"~     The aim of this longitudinal randomized investigation is to determine the long-term effects~     of early headgear treatment on craniofacial structures and dental arches, compared to~     treatment started later, during the most active growth period in Class II patients.~      The aim was further to find out the possible benefits and the burden of early treatment to~     the patients and parents of these common malocclusions, when compared to groups treated~     later, but with the same methods as much as possible.~      The hypothesis is that the timing of treatment has significant effects on orthodontic~     treatment total time, the general outcome of the treatment, and the compliance of the~     patient.~   "
79997|NCT02010333|"~     The primary purpose of the study is to evaluate safety and tolerability of a single~     application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to~     evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric~     population.~   "
79998|NCT02010320|"~     Dosing of tacrolimus is challenging due to the large inter-individual variation in its~     pharmacokinetics. The investigators have developed a pharmacokinetics population model that~     can be used to estimate individual doses of tacrolimus in renal transplant recipients. The~     model will be prospective tested in a randomized clinical trial.~      The hypothesis is that the computer model is superior to experienced transplant physicians~     in reaching and keeping the patients in the target range of tacrolimus.~   "
80379|NCT02004353|"~     The purpose of this study is to collect patient related benefit data following treatment for~     permanent hearing loss with a hearing implant from the company Cochlear over a period of 2~     years post treatment.~      Assessment of benefits is based on standard questionnaires of hearing ability and quality of~     life in general.~   "
80003|NCT02010255|"~     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus~     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic~     genotype 1 or 4 hepatitis C virus (HCV) infection.~        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;~        -  Cohort B: post-liver transplant, with or without cirrhosis;~        -  Group assignment within cohorts is based on severity of liver impairment at screening~          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence~          of disease for fibrosing cholestatic hepatitis (FCH) groups)~        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.~   "
80004|NCT02010242|"~     NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic~     complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4~     inhibitor.~      The primary objective of this study is to evaluate the efficacy of oral GKT137831 in~     patients with residual albuminuria despite maximal inhibition of the renin angiotensin~     aldosterone system.~   "
80005|NCT02010229|"~     The purpose of this study is to identify what factors -either individual or related to the~     type of management received- influence the maternal outcomes in pregnant women at high risk~     for placenta accreta i.e , women with placenta praevia and previous caesarean.~      This population-based study conducted in 8 French regions will also provide valid estimation~     of the incidence of placenta accreta among all parturients and among at risk women.~     Finally, a psychological evaluation of these women up to 1 year after delivery will provide~     information on the impact of these conditions on women, beyond somatic complications.~   "
80006|NCT02010216|"~     This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra~     (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8~     mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic~     therapy, for 12 weeks.~   "
80007|NCT02010203|"~     This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label,~     safety study. Patients will have previously received 3-6 instillations of weekly~     intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed~     by low dose intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be~     assigned to treatment groups based on whether they will receive induction BCG in the typical~     post-TURBT window. If the investigator plans to administer BCG, patients will be randomized~     to one of three blinded (physician-patient), placebo-controlled groups and receive either~     intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L~     in combination with induction and maintenance intravesical BCG. If patients will not receive~     BCG, they will be enrolled into an open-label, non-randomized group and receive high dose~     (1*10^7 cells) intradermal HS-410 monotherapy.~   "
80008|NCT02010190|"~     This is an observational study that will collect data from adult survivors of childhood~     cancer and compare it to data collected from age- and gender-matched controls for the~     purpose of assessing vascular risk among cancer survivors.~      Advances in cancer therapies have led to increasing numbers of adults previously treated for~     a pediatric malignancy, many of whom experience late adverse health-related sequelae and are~     at risk for developing chronic conditions related to their prior therapy. The epidemiology~     of many end-organ toxicities has been described, yet the pathophysiologic mechanisms of~     injury are incompletely understood. One mechanism may be damage to the circulatory system,~     in particular the endothelial layer, initiating an inflammatory state leading to dysfunction~     and premature atherosclerotic disease. This process may begin and significantly progress in~     a sub-clinical nature for many years prior to manifesting as a cardio- or cerebrovascular~     event. Using established and novel biomarkers predictive of atherosclerotic disease combined~     with unique measurements of vascular function, this study will assess pre-clinical vascular~     disease in a population of childhood and adolescent cancer survivors. The goals of this~     project are to investigate the effects of cancer therapy on the vascular system and acquire~     new knowledge with which to risk-stratify survivors and plan interventional studies to~     prevent or reduce premature vascular morbidity and mortality.~   "
80009|NCT02010177|"~     To assess the ability of baseline clinical parameters and imaging modalities to predict~     short and long term left ventricular function and clinical outcome of subjects with~     low-gradient, severe aortic stenosis.~      To assess the impact of aortic valve replacement as compared to medical therapy on clinical~     outcome of patients with low-gradient, severe aortic stenosis.~      To assess possible impact of aortic annulus assessment using 3-dimensional imaging~     modalities on the assessment of AS severity and definition of low gradient severe aortic~     stenosis.~   "
80010|NCT02010164|"~     Delaying first childbirth is a progressive trend in the developed societies. Several~     theories tried to explain the reproductive aging, in purpose to hasten it. One of the~     theories include mitochondrial dysfunction with aging. In this study we will investigate the~     potential of treating elderly IVF patients with CoQ10, a mitochondrial stimulator, to~     improve follicle cells' properties.~   "
80011|NCT02010151|"~     The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and~     Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac~     arrest (OHCA).~   "
80012|NCT02010138|"~     Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were~     equally randomized to small extent group or large extent group depending on the extent of~     internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the~     radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary~     analysis was conducted to identify the difference of functional and anatomical outcomes~     between the two groups. Subsequent analysis was performed to reveal the relationship between~     the functional and anatomical outcomes.~   "
80037|NCT02009813|"~     Obesity is an epidemic in Western society and is the biggest risk factor for insulin~     resistance and type 2 diabetes. The investigators have recently shown that exposure to~     hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that~     this improvement can be measured in all men, not just those with diabetes. The aim of this~     study is to investigate the time course of this effect and explore the mechanisms involved.~     The investigators suspect that insulin sensitivity as measured by~     hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour~     hyperbaric oxygen exposure, and that the improvement will be measurable in females as well~     as males.~   "
80013|NCT02010125|"~     This study will evaluate the bio-mechanical and biochemical abnormalities in acute~     ACL-injured knees over time. Data will be collected through advanced quantitative MR~     imaging, functional testing, and bio-specimen collection. Researchers will collect this data~     from the time of baseline visit, which is within 28 days of injury, through the temporal~     sequence of post-operative or post-injury recovery and return to activity.~      The hypotheses for this study are (1) that T1ρ and T2 will be significantly elevated in the~     lateral side of ACL-injured knees immediately after injury (indicating damage caused by~     initial injury), and will not fully recover at 6-month, 1-year follow ups; (2) that T1ρ and~     T2 will be significantly elevated in the medial side of ACL-injured knees at 1-year~     follow-up; and (3) that differences in the bio-marker expression patterns can be correlated~     with the initial MRI findings, which would provide information regarding the full spectrum~     of intra-articular pathology and the subsequent clinical outcomes.~   "
80014|NCT02010112|"~     A new method of breath collection for testing for Helicobacter Pylori infection has been~     developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy~     results to prove its accuracy.~   "
80015|NCT02010099|"~     Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product~     (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).~      Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control~     product usage: according to label, 3-4 times daily application to rectal region.~      At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge,~     swelling, itching, discomfort and painkiller usage.~      Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing~     treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are~     examined by study physician who assesses hemorrhoid severity.~   "
80016|NCT02010086|"~     The study is a randomized controlled trial to examine the efficacy of individual cognitive~     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with~     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last~     five years to the clinical needs of high-functioning youth with ASD.~   "
80017|NCT02010073|"~     We wish to prospectively assess the burden of, management and therapeutic approaches to, and~     outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the~     winter months in both the northern and southern hemispheres. We wish to specifically examine~     the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic~     respiratory failure.~      Why?~      The purpose of this study is to provide new and current data on the disease burden of acute~     hypoxemic respiratory failure and ARDS. It will answer the following questions:~        -  What is the frequency and disease burden of acute hypoxaemic respiratory failure in~          winter?~        -  What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory~          support?~        -  What is the incidence of ARDS based on the Berlin definition within this patient~          cohort?~        -  What is the mortality from ARDS within this cohort, and how does this vary based on~          ARDS severity?~        -  What is the natural history of ARDS?~        -  What are the key patterns of therapeutic resource utilization, particularly approaches~          to sustain gas exchange, in these patients?~      When?~      The study is performed over a 4 week period between February 1st and March 31st 2014 in the~     Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.~      What data is required?~      A basic dataset is collected on all patients admitted with acute acute hypoxaemic~     respiratory failure requiring ventilatory support, with a more detailed dataset collected on~     patients diagnosed with ARDS.~   "
80018|NCT02010060|"~     This study will determine the health benefits of combining exercise training and increasing~     the amount of physical activity in daily life on the fat around the abdomen, weight, fitness~     and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months:~     1) a control group, 2) exercise training only, or 3) exercise training and increasing~     physical activity outside of training. The exercise training will follow the public health~     recommendations for exercise (150 minutes/week of moderate exercise). The group increasing~     physical activity along with exercise training will be asked to increase physical activity~     in their daily life (up to 3,000 step/day above their current levels through the use of step~     counters), and meetings focused on behavior modification. The investigators hypothesize that~     combining aerobic training and additional physical activity after training will have the~     most profound reduction on waist circumference and body composition.~   "
80019|NCT02010047|"~     The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung~     cancers. Testing for this gene is important because there are drugs known as ALK inhibitors~     that have been shown to significantly delay the progression of ALK-mutated lung cancers.~     There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy~     tissue. One method involves making slides and staining them to detect the ALK protein. This~     is called immunohistochemistry. Another method called fluorescence in situ~     hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung~     cancer. Although both these tests are widely used to test for ALK gene abnormalities, the~     techniques may not always find the ALK gene mutation because they are not sensitive enough~     or not enough cancer cells are present in the lung biopsy.~      This study is being performed to determine if a technique called quantitation polymerase~     chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung~     cancer biopsy tissue.~   "
80020|NCT02010034|"~     This study is being done to determine if an investigational study drug called Omegaven can~     help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN~     is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are~     unable to drink fluid or eat food by mouth.~   "
80038|NCT02009800|"~     This randomised clinical trial aims to determine whether an immunization schedule comprising~     two doses of Gardasil administered six months apart is non-inferior to a schedule comprising~     three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18~     infections that persist for at least six months, up to ten years after the initial~     vaccination.~      The study hypothesis is that the two-dose schedule would offer similar protection as that of~     a three-dose schedule against persistent HPV-16/18 infections.~   "
80039|NCT02009787|"~     The investigators planned to research the effect of vitamin D supplementation as an adjuvant~     therapy for patients with hypercholesterolemia.~   "
80021|NCT02010021|"~     Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is~     prevents cells from producing estrogens. This should assist with the slowing of growth of~     tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction~     pathway.~      The objectives of this study will look at the differences between the cellular destruction~     pathway before and after letrozole use, and the differences in the cellular destruction~     pathway in participants that have received letrozole versus those who did not. The study~     will also look at a gene in all participants called Ki67. This gene is associated with the~     rate of tumor cell growth. The study will measure the levels of Ki67 and compare them to the~     amount of activation of the cellular destruction pathway.~      Participants in this study will have undergone a diagnostic biopsy of their breast tissue.~      In order to meet these objectives, one group of participants (Arm A) will not receive~     letrozole. Tissue leftover from their diagnostic biopsy will be treated with RAD001~     (Everolimus) in the laboratory and the effects of this drug on the cellular destruction~     pathway will be studied.~      The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum~     of 21 days. They will have a second tumor sample taken as part of their surgical procedure~     completed to remove the tumor tissue. Any differences in the cellular destruction pathway~     before and after exposure to letrozole will be measured.~   "
80022|NCT02010008|"~     ¡Fortaleza Latina! is a multi-level randomized trial to increase participation in~     mammography screening among Latinas who seek care at a community health center in Western~     Washington.~      In partnership with the partnering community health center, we have obtained lists of women~     patients aged 42 to 74 years old who had not had a mammogram in the last two years and~     resided within defined radii of the four clinics. Baseline and one year follow-up surveys~     will be obtained by in person home interview. Participants are randomized within clinic to~     intervention or comparison group. The intervention consist of two motivational interviewing~     sessions, one in person in the home, and one telephone follow-up. The study hypothesis is~     that a higher proportion of participants in the motivational interviewing arm will obtain a~     screening mammogram within the study period than those in the comparison arm.~   "
80023|NCT02009995|"~     BACKGROUND Resistance exercise training with free weights or weight machines clearly~     improves glucose (sugar) control in type 2 diabetes (T2D). However, many patients with T2D~     would prefer not to attend an exercise facility, for reasons of cost and/or convenience.~     Coinvestigator Jonathon Fowles has developed and pilot-tested a home-based exercise program~     for people with T2D using resistance bands. However, the effects of resistance-bands~     training (on glucose control in T2D have not been evaluated in a high-quality randomized~     trial.~      SPECIFIC AIMS To determine the effects of six months of progressive home-based resistance~     bands training (RBT) versus no RBT in people with T2D on blood glucose control (HbA1c,~     primary outcome), waist circumference, heart disease risk factors, and quality of life.~      METHODS A total of 100 T2D participants will be randomized to 2 arms: home-based RBT (RBT-H)~     or aerobic training only (ATO). Both groups will accumulate 150 minutes per week of aerobic~     exercise such as walking. The resistance exercise workout includes 12 exercises, targeting~     all major muscle groups. RBT-H subjects will complete most exercise at home with periodic~     supervision.~      SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the~     illness occur primarily in those whose glucose control is fair or poor. If exercise training~     with resistance bands improves glucose control, it could be beneficial to the large numbers~     of patients who cannot travel to a gym or cannot afford gym membership. If resistance~     exercise is then adopted by more patients, it is likely that the morbidity associated with~     type 2 diabetes will be decreased. This is particularly true if such training also improves~     quality of life, and more people are thus inclined to continue exercising in the long term.~   "
80024|NCT02009982|"~     The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the~     treatment of neurocardiogenic syncope (NCS), also known as vaso-vagal syncope. Syncope is~     a general term for passing out spells and neurocardiogenic syncope is a specific form of~     passing out spells caused by sudden drops in heart rate or blood pressure. Although the~     specific mechanisms of NCS are not well understood, it is believed that some people are~     prone to developing passing out spells in specific situations such as standing up for a long~     period of time, pain or nausea. In these situations, the body reacts with a paradoxical~     reflex which leads to a drop in blood pressure and heart rate and causes passing out.~     Certain types of medications are used to treat NCS including beta-blockers, midodrine and~     florinef, among others. However, none of these medications are particularly effective at~     preventing passing out spells and many people continue to have episodes despite trying~     different medications.~      Cardioneuroablation is a new form of treatment for NCS. The term ablation means using a wire~     to make small electrical burns in the heart. Ablation has been used for many years to treat~     other electrical disturbances in the heart but the use of ablation to treat NCS is a new~     application. The goal of cardioneuroablation is to identify areas within the heart which are~     believed to initiate the reflex which triggers the drop in heart rate and blood pressure~     that leads to passing out. In preliminary studies, it has been suggested that~     cardioneuroablation may be significantly more effective than medications at preventing~     passing out spells for people with NCS.~      Hypothesis: Cardioneuroablation of vagal inputs in the left atrium may serve as an effective~     treatment modality for the prevention of NCS by blunting the initial trigger of the cascade~     that leads to symptoms and syncope.~   "
80025|NCT02009969|"~     The purpose of this study is to compare abdominal weight gain and fat distribution to~     changes in brain morphology in people taking antipsychotic medications.~   "
80026|NCT02009956|"~     To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent~     System and the DESyne BD Novolimus Eluting Coronary Stent System~   "
80040|NCT02009774|"~     Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the~     colon. At the present moment, all polyps should be resected endoscopically, although only~     adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This~     approach enables the conduction of microscopic investigations of the lesions. By today, only~     the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps.~     Some studies have investigated the value of the socalled optical biopsy method. Optical~     biopsy means the visual assessment of the polyp and the determination of a diagnosis solely~     on behalf of optical criteria. This method is conducted in real time during colonoscopy. If~     it can be shown, that endoscopist using optical biopsy are able to predict histopathological~     diagnoses of colonic polyps sufficiently this would possibly lead to simplification of~     diagnostic procedures. For instance, it would be conceivable to resect hyperplastic polyps~     and small adenomas and discard them without further assessment by a pathologist.~     Gastroenterological societies demand for a 90 percent accordance between diagnoses set by~     endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy~     method.~      In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera~     III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic~     polyps. NBI is a light filter tool which can be activated by pressing a button at the~     endoscope. NBI function leads to an endoscopic picture which appears blue and enables~     endoscopists to better assess surface structures and vascular patterns.~      In a prospective randomised multicenter setting we plan to conduct colonoscopy in 380~     patients. Half of the patients will be examined without use of NBI (control arm). In these~     cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI~     tool. If polyps are detected in patients belonging to the intervention arm NBI will be used~     and optical diagnosis will be determined using the NICE (NBI International Colorectal~     Endoscopic) classification. All polyps will be resected and send to pathology for further~     microscopic assessment. After completing the trial we aim to compare accuracy of the optical~     diagnosis in both groups. Our hypothesis is, that by using the new NBI tool accuracy~     (accordance between optical and histopathological diagnosis) can be increased from 78% to~     90%.~   "
80027|NCT02009943|"~     The inflammatory response associated with surgical critical illness rapidly induces a~     functional iron deficiency, characterized by hypoferremia, decreased transferrin saturation~     (TSAT), hyperferritinemia, and iron-deficient erythropoiesis (IDE). This functional iron~     deficiency both contributes to intensive care unit (ICU) anemia and increases the packed red~     blood cell (pRBCs) transfusion requirement.~      The goals of iron supplementation of critically ill surgical patients are to reverse the~     serum iron debt, eliminate IDE, improve anemia, and decrease pRBCs transfusions. Issues~     surrounding iron supplementation of this patient population include formulation, dose, route~     of administration, and mitigation of the complications of iron overload, including~     infection.~      The investigators first randomized clinical trial (RCT) of iron supplementation of~     critically ill surgical patients compared enteral ferrous sulfate 325 mg thrice daily to~     placebo (NCT00450177). Although a significant reduction in pRBCs transfusion requirement for~     the iron group was observed, low injury severity, intolerance of enteral medications, and a~     predominance of traumatic brain injury limited generalizability. In a second multicenter~     RCT, the investigators compared intravenous iron sucrose 100 mg thrice weekly to placebo~     among critically ill trauma patients (NCT01180894). Iron supplementation at this dose~     increased the TSAT only marginally (and not above the normal range) and increased the serum~     ferritin concentration significantly; however, there was no effect on IDE, anemia, or pRBCs~     transfusion requirement. In no instance did iron supplementation increase the risk of~     infection, despite a relatively high incidence of marked hyperferritinemia (serum ferritin~     concentration > 1,000 ng/mL) in the iron group.~      The severity of both the serum and bone marrow iron debts observed in these trials led us to~     investigate alternative dosing schemes that deliver larger quantities of bioavailable iron~     safely. Ferric carboxymaltose (FCM) is a novel iron-containing complex that allows for the~     administration of a large replenishment dose of iron (up to 750 mg) over a short infusion~     period. Several pharmacodynamic properties of FCM render it appealing for use in the~     treatment of functional iron deficiency associated with surgical critical illness, including~     a short infusion time, a controlled, sustained delivery of iron to target tissues over a~     relatively long period of time (up to one week), and minimal hypersensitivity reactions.~     Increased efficacy and comparable safety have been reported for FCM as compared to iron~     sucrose for treatment of outpatients with iron-deficiency anemia. There are currently no~     data regarding the efficacy of FCM for the indication of functional iron deficiency~     associated with surgical critical illness.~      The aim of the current pilot trial is to compare two novel dosing schemes for treatment of~     function iron deficiency in surgical ICU patients, both of which involve delivery of a~     larger total dose of iron as compared to both NCT00450177 and NCT01180894. The investigators~     hypothesize that iron supplementation with FCM, as compared to both iron sucrose and~     placebo, is more effective and equally safe for replacing the serum iron debt.~   "
80028|NCT02009930|"~     Hypothesis: Enlisted military members with 10 or more years of service and at least one~     cardiovascular risk factor will demonstrate a higher risk of future cardiac events as~     assessed by coronary artery calcium scoring than the risk calculated by the Framingham Risk~     Score.~   "
80029|NCT02009917|"~     Protein is a major structural component of all cells in the body. The nutritional importance~     of protein is because of their amino acids. 9 are called essential and 11 are called~     non-essential, based on whether we need to get them from diet. This classification is based~     on studies done using older techniques. Recent studies suggest that these so called~     non-essential amino acids play important roles in our body's health. For the first time,~     this proposal defines an experimental design to examine non- essential amino acid/nitrogen~     requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO)~     technique.~      The objective of the current study is to examine the application of IAAO technique to~     determine the non-essential amino acid/nitrogen requirement in adult humans.~   "
80030|NCT02009904|"~     Phenylketonuria(PKU)is a rare condition caused by the body's inability to properly breakdown~     an amino acid called phenylalanine(PHE), due to a missing enzyme, phenylalanine~     hydroxylase(PAH). When the enzyme is missing and/or not functioning properly, it increases~     the level of PHE in the body. High levels of PHE can cause severe brain damage or nerve~     damage unless the children are on a strict low PHE diet. A low PHE diet restricts the intake~     of protein rich foods and can pose a significant burden to both the patient and the family.~      Investigators at the University of British Columbia and British Columbia Children's Hospital~     will examine the phenylalanine metabolism in children with PKU using a simple breath test.~      Patients (5-18y) receiving standard clinical care at the BC Children's Hospital's~     Biochemical Diseases Clinic will be enrolled.The study will be conducted twice on each~     patient. Baseline measurements will be performed at the beginning of each study for each~     patient.The Physician in charge will then prescribe the standard dose of sapropterin~     dihydrochloride (Kuvan®) (20mg/kg/d) or otherwise as deemed appropriate by the~     physician-in-charge. The test will be repeated a week (minimum) after the beginning of~     treatment with the prescribed dose.~      The investigators propose that children who are responsive to sapropterin dihydrochloride~     (Kuvan®) will have increased 13CO2 in breath after treatment, and those who do not respond~     will have no change in the 13CO2 in the breath before and after treatment.~      As a comparison to the experimental group, age and gender matched healthy controls will also~     be studied. The test in healthy controls will be performed once without any intervention,~     and is only used as a comparative value.~   "
80031|NCT02009891|"~     To determine in women undergoing IVF who are at high risk of multiple births (>35%), as~     calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer~     will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such~     as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while~     reducing the incidence of multiple births (a secondary outcome measure).~   "
80032|NCT02009878|"~     This is a study to evaluate how the body handles and metabolizes (PK) the various doses of~     the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the~     content of salt in blood and urine~   "
80033|NCT02009865|"~     This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy~     and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects~     with severe hypertriglyceridemia. The study consists of an approximately 8-week screening~     period that includes a diet and lifestyle stabilization and washout period and a 12-week~     treatment period.~   "
80034|NCT02009852|"~     The Role of microRNA-29b in the Oral Squamous Cell Carcinoma~   "
80035|NCT02009839|"~     The main aim of this study is to examine the effectiveness of a web-based CBT protocol~     (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The~     researchers hypothesized that the Meeky Mouse program would be associated with higher~     frequency of speaking behaviors, lower levels of anxiety, greater improvements in~     clinician-rated severity of mental illness, and higher clinician-rated improvement scores at~     post-treatment.~   "
80036|NCT02009826|"~     Previous research has suggested central nervous system inflammatory activity to be~     critically involved in disease development and progression in schizophrenia, with a complex~     interplay of inflammatory mechanisms leading to the development of brain abnormalities and~     medical symptoms related to schizophrenia. However, the mutual interactions of different~     inflammatory pathways and their relation to disease course have not been sufficiently~     studied. This study therefore aims to explore the interaction of neuroinflammatory~     mechanisms in patients with schizophrenia and to assess whether the inflammatory activity in~     schizophrenia is state-dependent and occurs mainly during psychotic episodes.~   "
80043|NCT02009735|"~     To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza~     Virus detection, the investigators conduct a prospective clinical study. In comparison with~     results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators~     evaluate the performance of virosensor , including reproducibility, sensitivity,~     specificity, and cross-reaction. The potential factors which may interfere with the results~     would be investigated. With such technique, the investigators hope to make early diagnosis~     and give Enterovirus 71 and Influenza Virus patients early treatment to reduce the~     complications and case-fatality rate.~   "
80044|NCT02009722|"~     Both hydromorphone and morphine are administered as part of spinal anesthesia to help~     improve pain control after cesarean delivery. In this study, the investigators are going to~     determine the doses of each of those medicines that provides optimal pain control to women~     undergoing cesarean delivery while limiting side effects related to those medicines. The~     investigators hypothesize that the doses of hydromorphone and morphine that provide optimal~     pain control without significant side effects will be 100 micrograms and 150 micrograms,~     respectively. The investigators further hypothesize that at each respective optimal dose,~     side effects will be less in the hydromorphone group.~   "
80045|NCT02009709|"~     The primary objective of this study is to determine the effectiveness and safety of corneal~     collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.~   "
80046|NCT02009696|"~     The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the~     ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.~   "
80047|NCT02009683|"~     In this study the investigators aim to build a model to predict the maintenance of sinus~     rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard~     predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG~     parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide~     polymorphisms (SNPs). Using this novel integrated prediction model will help in the~     identification of patients who will maintain SR after cardioversion. Another innovative~     aspect of our study is the use of daily rhythm monitoring using a versatile device~     (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist~     to make a patient tailored strategy in the treatment of AF as advocated by the guidelines~     and to prevent exposing patients not likely to maintain SR to the potentially harmful~     side-effect of a rhythm-control strategy.~      Primary objectives To show that a model incorporating the novel predictors 17-lead ECG,~     Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus~     rhythm after successful DCC in patients with persistent AF.~      Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG,~     17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.~      To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs)~     for time to recurrence of AF.~      To assess the predictive value of predictors with respect to complete failure of~     cardioversion.~      To assess the predictive value of predictors with respect to cardiovascular morbidity.~      Hypothesis The investigators hypothesise that a model incorporating the novel predictors the~     17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models~     using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in~     predicting maintenance of SR after successful DCC. In addition the investigators hypothesise~     that Oesophageal-ECG is the best single predictor for maintenance of SR after successful~     DCC.~   "
80048|NCT02009670|"~     In this placebo controlled, double-blind, randomized crossover study the investigators will~     investigate in overweight/obese healthy male volunteers whether inulin administration will~     increase intestinal SCFA production, thereby investigating whether this will lead to acute~     metabolic effects.~   "
80049|NCT02009644|"~     The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the~     Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic~     Aneurysms (AAA).~   "
80050|NCT02009631|"~     This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac~     repolarization in patients with solid tumors who's cancer has recurred or is no longer~     responding to current treatment.~   "
80051|NCT02009618|"~     To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced~     examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel~     syndrome, and implement it into clinical practice.~   "
80052|NCT02009605|"~     This study is designed to evaluate the efficacy of icotinib at routine dose in previously~     treated non/light-smoking patients with advanced squamous cell lung cancer.~   "
80053|NCT02009592|"~     Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it~     encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually~     leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life~     style, type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease~     progression. Research on the role of gut-liver axis in the pathogenesis of NAFLD has been~     slowly accumulating over the past few years. Endotoxemia resulting from intestinal bacterial~     overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve~     as a potential therapeutic target in NASH. In this regard, we have aimed to test the~     efficacy of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects~     in relation to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis~     that Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and~     partial alleviate from NAFLD/NASH.~   "
80054|NCT02009579|"~     Indication:~      Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior~     radiochemotherapy or neo-adjuvant chemotherapy is allowed.~      Study design:~      This is a phase II randomized, double blind and placebo controlled trial evaluating the~     efficacy of Nintedanib/placebo in combination with the standard of 6 cycles 3 weekly~     carboplatin and paclitaxel followed by Nintedanib/placebo maintenance in the treatment of~     patients with advanced or recurrent cervical cancer.~      A total of 120 patients will be randomized between the experimental and control arm in a 1:1~     ratio. Randomization will be stratified for 1previous therapy (chemo-radiotherapy or~     neoadjuvant chemotherapy: no, >6 months since last platin course) and 2disease status (Stage~     IVB primary versus recurrent disease).~      Experimental arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) +~     paclitaxel (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until~     progression or for a total maximum duration of 120 weeks.~      Control arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel~     (175 mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for~     a total maximum duration of 120 weeks.~      Subjects without evidence of disease progression after completion or discontinuation of the~     study treatment will be followed until radiographic disease progression, withdrawal of~     consent or death.~   "
80055|NCT02009566|"~     Surgical sponges can be accidentally left inside patient's bodies. We are working on special~     tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the~     surgeons forget to remove a sponge from a patient, they'll be able to detect these special~     tags in an x-ray.~   "
80056|NCT02009553|"~     Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is~     that pre-procedural explanation note about the test may reduce the anxiety level of the~     patients.~   "
80057|NCT02009540|"~     Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or~     bladder muscle, which gives rise to symptoms of urinary urgency and often urinary~     incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for~     the bladder muscle instability is unknown.~      OAB is usually treated by conservative measures or with oral medications eg.~     anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is~     licenced in the treatment of refractory IDO where oral medications fail. The injected toxin~     paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with~     the bladder muscle. As these nerves are mainly concentrated in what is known as the body~     of the bladder this is traditionally where the injections are given.~      In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways.~     Recent studies show that IDO is caused by both motor and sensory nerve dysfunction,~     therefore injecting the trigone, a part of the bladder where sensory nerves are~     particularly dense, may be of clinical benefit. Three studies comparing trigone versus~     trigone-sparing injection of botulinum toxin in the treatment of IDO have been carried out.~     One of these indicated a significant benefit in targeting the trigone and the other two did~     not show any difference.~      Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide~     symptom and functional improvement in patients with IDO by comparing peritrigonal injection~     of onaBoNT-A with the traditional method of injection which spares the trigone.~   "
80058|NCT02009527|"~     The present project is designed to test the hypothesis that arginase contributes to~     endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery~     disease.~   "
80059|NCT02009514|"~     The purpose of this study is to investigate differences in glycemia~        -  during the whole hemodialysis day and the whole freeday~        -  during hemodialysis, during the evening and the night after hemodialysis and at the~          same time intervals during the freeday in an unselected type 2 diabetic patient group~          using both glucose-containing and glucose-free dialysate.~   "
80060|NCT02009501|"~     This study would like to determine if using negative pressure wound therapy with an~     instillation of .125% Dakins is more effective than using negative pressure wound therapy~     alone on biofilm removal, disruption and elimination in chronically infected lower extremity~     wounds.~   "
80061|NCT02009488|"~     The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic~     fat content and beta cell function after approximately 24-25 weeks of treatment with~     canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with~     inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy~     with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.~   "
80062|NCT02009475|"~     The aim of the present study is to evaluate differential lactate removal kinetics in heart~     failure patients that are trained according to 2 different exercise protocols:~      (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)~   "
80063|NCT02009462|"~     Artefill is an injectable facial filler device that is currently approved by the FDA for the~     correction of nasolabial folds. This study seeks to examine the use of Artefill in the~     treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related~     to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the~     cheeks and temples.~   "
80064|NCT02009449|"~     This is a first-in-human, open-label, dose escalation study to evaluate the safety and~     tolerability of AM0010 in patients with advanced solid tumors, dosed daily subcutaneously as~     a monotherapy or in combination with chemotherapy or immunotherapy.~   "
80065|NCT02009436|"~     This pilot phase I trial studies the side effects and best dose of azacitidine in treating~     patients with lung cancer that is stage IV or has returned after previous treatments~     (recurrent). Azacitidine is a drug used in chemotherapy that may stop tumor cells from~     growing or spreading by activating genes that help prevent cancer growth, called tumor~     suppressor genes. As people age, these genes are silenced by a chemical reaction that occurs~     naturally in the body, or by exposure to environmental factors such as smoking. Azacitidine~     may help reverse this process and restore the function of the tumor suppressor genes.~     Delivering azacitidine directly into the lungs by inhalation may work better in treating~     lung cancer.~   "
80066|NCT02009423|"~     The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to~     placebo.~   "
80067|NCT02009410|"~     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion~     of fat, sugars and proteins) in diabetes type II~   "
80068|NCT02009397|"~     The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both~     ipilimumab and GM-CSF are intended to work with the body's own immune system to attack~     melanoma cells in the body. This study will also demostrate how safe the combined drugs are~     when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which~     cannot be removed by surgery.~   "
80069|NCT02009384|"~     This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and~     Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42~     patients with radiographically measurable melanoma who have received at least one cycle of~     Denileukin Diftitox will be enrolled and treated in the study.~   "
80070|NCT02009371|"~     The purpose of this study is to investigate the efficacy and safety of light-emitting~     diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder~     and to gather prime research data and application parameters of LED light source which is~     not currently available in China.~   "
80071|NCT02009358|"~     The goals of this research were to conduct a mental health intervention study for reducing~     self-reported depression and anxiety among migrant workers in a labor-intensive industry in~     China and to assess the effectiveness of the integrated mental health interventions aimed at~     promoting the mental health of migrant workers in labor-intensive industries in China.~   "
80101|NCT02008968|"~     Several studies showed that hyperuricemia is an independent risk factor for development of~     diabetes mellitus. However none of the previous studies have investigated the effect of~     lowering serum uric acid levels on insulin resistance of which is also named as prediabetes.~     With this background in mind, we aimed to test the effect of lowering serum uric acid level~     with allopurinol on insulin resistance.~   "
80102|NCT02008955|"~     The lysine requirement of elderly female subjects 65-75 years old will be 40-45 mg/kg/day.~   "
80072|NCT02009345|"~     Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder~     associated with premature CAD. In Canada, the burden of disease is estimated to be~     approximately 83,500 patients. The goal of this initiative is to create a registry of~     subjects with FH across Canada. Rare diseases of lipoprotein metabolism will also be~     included. Using a hub and spoke model, the registry will be extended in various~     communities to link primary care physicians with provincial academic centers. The registry~     will include clinical, biochemical and demographic information. Specimens (plasma/serum and~     DNA) will be collected for biobanking. We propose a three-tier registry: local, provincial~     and Canada-wide, which will be completely anonymized. The registry will be made available~     for clinicians to manage patient care, identify relatives for screening and treatment~     (cascade screening), to provide advice to general practitioners and to support collaborative~     studies in biomedical, clinical, health outcomes and health economics research. The data~     extracted for the provincial portion of the database will allow administrative database~     research that will provide important information to key stakeholders and permit allocation~     of resources. It will also allow a sound and uniform rationale for the use of novel~     therapeutic agents and provide expert advice to regulatory agencies. At the Canadian level,~     the database will allow clinicians and researchers to determine the burden of disease and~     the long-term effects of treatment. Through the creation of a Canada-wide network of~     academic clinics, integrating lipid specialists, endocrinologists and cardiologists, the~     Canadian FH registry will lead to significant benefits for FH patients, clinicians and~     researchers, biopharmaceutical industry and government.~   "
80073|NCT02009332|"~     Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety~     and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer~   "
80074|NCT02009319|"~     The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of~     mediastinal lymph nodes in patients with suspicion for lung cancer for the first time.~     Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with~     tissue diagnosis as a gold standard.~   "
80075|NCT02009306|"~     When patients are dying they become unable to take oral medication and if they develop~     symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of~     medication. If they are at home this requires that a District Nurse is called and it can~     take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful~     time for the patient and family.~      There are 2 drug preparations which could potentially be given by family members in the~     home:~      Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms~     this would give much quicker symptom control for patients and might mean the District Nurse~     visit was not needed.~      In advance of a community based randomised trial of these modes of administration, it is~     important to assess the feasibility of such an approach in terms of carer acceptability and~     patient tolerability as well as determine appropriate sample sizes and sampling methods.~     There are 2 work packages which would help assess feasibility of a community trial:~        1. An open label randomised controlled trial comparing the use of PecFent with or without~          Epistatus versus standard subcutaneous breakthrough medication for the management of~          breakthrough pain (with or without agitation) in dying hospice patients who either~          remain in the hospice or go home.~        2. A qualitative interview study to capture the thoughts of relatives of these patients~          about the use of these preparations.~   "
80076|NCT02009293|"~     In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients~     with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily~     practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of~     life.~   "
80077|NCT02009280|"~     The aim of this study is to investigate whether propofol based total intravenous anesthesia~     reduces incidence of acute kidney injury following the lung transplantation under~     extracorporeal membrane oxygenation~   "
80078|NCT02009267|"~     A retrospective chart review study analyzing the benefits of patient controlled analgesia,~     thoracic epidural analgesia, and paravertebral nerve block catheters in patients having~     surgical repair of pectus excavatum using the Nuss procedure.~   "
80079|NCT02009254|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of consuming instant mashed potatoes with~     and without fat on glycemic response, subjective appetite and food intake. It is~     hypothesized that mashed potato with added fat (as it is usually consumed) will result in~     lower glycaemic response and subjective appetite, and reduced subsequent food intake.~   "
80080|NCT02009241|"~     Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is~     frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion~     capacity and dynamic hyperinflation (DH).~      Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea,~     and quality of life in chronic obstructive pulmonary disease. There are no studies~     evaluating the impact of PR in patients with LAM.~      The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea,~     quality of life, muscle force, functional limitation and DH in these patients.~   "
80081|NCT02009228|"~     Minimally invasive surgery has become the standard treatment for many gynecologic disease~     processes. In the last decade, numerous studies have demonstrated that laparoscopic~     approaches to various gynecologic oncology conditions-particularly for early-stage~     endometrial and cervical cancers as well as select pelvic masses-is feasible and results in~     shorter hospital stays, improved quality of life and comparable surgical and oncologic~     outcomes to abdominal staging.For instance, the typical gynecologic robotic surgical~     procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently,~     an even less invasive alternative to conventional laparoscopy surgery has been developed:~     laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port~     laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive~     surgery while minimizing the potential morbidity associated with multiple incisions.~     Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate~     that the techniques are feasible provided that both optimal surgical technical expertise~     with advanced skills and optimal instrumentation are available. Recently, several~     publication showed the single port laparoscopic surgery is feasibility in gynecologic~     surgery including oophorectomy, cystecomty, and myomecomty. To our knowledge, the sample~     size of recent publication about single port surgery including cystectomy and myomecomty is~     small. Furthermore, these studies lack the comparison of single port and convectional~     laparoscopic surgery. Base on our recent study demonstrated that either the single-port or~     the conventional approach can be used for LAVH, but the single-port LAVH technique yielded~     less postoperative pain (Chen et al., Obestet Gynecol, 2011). The purpose of this study was~     to assess the feasibility of single port laparoscopic surgery in the treatment of benign~     gynecologic disease.~   "
80082|NCT02009215|"~     We propose to evaluate the community-level impact of intermittent preventive treatment (IPT)~     for malaria in schoolchildren on clinical outcomes and malaria transmission, using a~     cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be~     administered to schoolchildren monthly for up to six rounds of treatment during one school~     year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito~     vectors. Our proposal also includes health service research to evaluate the potential~     feasibility of taking the programme to scale, which will guide future research and~     implementation of the intervention, and help shape policies in Uganda and elsewhere in~     Africa.~   "
80083|NCT02009202|"~     Colonoscopy is a routinely performed examination of children and adolescents in the~     diagnostic process of inflammatory bowel disease (IBD). It is necessary that the bowel is~     clean so the colonoscopy can be optimally performed. The cleansing of the bowel by means of~     laxatives prior to the examination is, however, considered difficult by many children.~     Getting smaller children to cooperate and to drink a substantial volume of laxative fluid~     prior to the examination can be particularly difficult. There are several possible cleansing~     procedures and combinations of procedures for the cleansing of the colon, for example by~     means of polyethylene glycol and sodium picosulphate, which are the two most commonly used~     methods. Cleansing by means of polyethylene glycol can, due to the necessary intake of a~     substantial quantity of fluid, be particularly frustrating for patients. Often the only way~     to carry out the preparation is with the insertion of a nasogastric tube, which can cause~     discomfort for some children. Cleansing the colon by means of sodium picosulphate, which~     involves an intake of a small quantity of fluid, has been suggested to be a good sufficient~     method resulting with a satisfactory result in terms of bowel cleanliness. However, studies~     have so far encompassed only a smaller number of children and further studies are needed to~     confirm that there is no difference between the two methods in terms of resultant bowel~     cleanliness.~      The purpose of this randomized controlled study is to compare preparation by means of~     polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in~     children.~      One hundred children scheduled for colonoscopy in southern Sweden will be randomized into~     either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for~     preparation with sodium picosulphate). For the random sampling, data-driven selection will~     be implemented. A CONSORT Flowchart (2012) will be encompassed by the study. To assess the~     cleanliness of the intestinal tract (and volume of fluid in the intestine), the Ottawa Scale~     will be used (Rostom & Jolicoeur, 2009). All colonoscopy examinations will be performed by~     the same paediatric gastroenterologist, to whom no information about which preparation~     method was used by each child will be disclosed. Furthermore, the gastroenterologist will,~     meet with the children first after the investigation has been completed. All information~     regarding the investigation will be given to the patient by the admitting physician. During~     the colonoscopy the gastroenterologist will evaluate the intestinal cleanliness and submit~     the reports in sealed coded envelopes to the nurse in charge of the patient.~   "
80084|NCT02009189|"~     Taurolidine alone or in combination with citrate have been proposed for locking the catheter~     to reduce the number of catheter infections. As there is not enough evidence to give~     recommendations in this regard, the study tested the hipothesis that taurolidine improves~     the outcome of long term paretneral nutrition.~   "
80085|NCT02009176|"~     The purpose of this study is to compare short-term and long-term efficacy of two surgical~     methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical~     method from the pathology and cytology.~   "
80086|NCT02009163|"~     To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and~     placebo, as measured by the number of binge days (defined as days during which at least 1~     binge episode occurs) per week as assessed by clinical interview based on subject diary and~     Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by~     the end of the Open-label Treatment Phase.~   "
80087|NCT02009150|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging~     technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates~     3D metabolic maps and based on sophisticated machine learning technology, provides objective~     risk assessment for the presence of malignant tumor. The procedure is non-invasive,~     comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional~     MIRA is unaffected by breast density and is therefore ideal for evaluating patients with~     mammographically dense breasts.~      The purpose of this clinical study is to assess the ability of this novel technology to~     detect clinically occult breast cancer in a cohort of women that are at high risk for breast~     cancer.~      We hypothesize that the combination of screening mammography and metabolic screening (3D~     MIRA) will result in significantly higher breast cancer detection rates.~   "
80088|NCT02009137|"~     Expected Total Number of Subjects~        -  Level of significance, alfa 0.05~        -  Power 0.80~        -  Mean difference between two treatments is assumed 35~        -  Standard Deviation is assumed 35.~        -  Follow-up loss is assumed 20%~        -  N=34(each group:17)~   "
80089|NCT02009124|"~     The purpose of this study is to study the effect of stem cell therapy on common symptoms in~     patients with spinal cord injury.~   "
80090|NCT02009111|"~     Couple CARE for Parents is a couple-focused intervention that addresses interpersonal~     processes within relationships and promotes relationship and parenting skills among couples~     with a newborn. Couple CARE for Parents uses an approach developed in Australia that was~     designed to be fairly easy and cost-effective to disseminate widely (i.e., home-visitation~     and video- and telephone-assisted skills training). It has demonstrated efficacy for~     significantly enhancing couples' relationship satisfaction in three Australian randomized~     trials.~      Arresting the normal decline of satisfaction of new parents to near-clinical levels is~     noteworthy because relationship dissatisfaction is one of the strongest predictors of~     partner physical assault. Managing relationship conflict is critical to the health and~     well-being of both parents and their children. Given the high prevalence of partner physical~     and emotional aggression (a precursor to the more serious form labeled intimate partner~     violence [IPV]) in new parents) among perinatal parents, the need for efficacious~     prevention services is acute.~      This randomized, controlled trial will test if couples with a newborn who receive Couple~     CARE for Parents report significantly less IPV than control couples who do not receive the~     program. This is a prevention trial. No couple will report ever having experienced IPV. All~     couples will have three empirically documented risk factors for the development of IPV:~     youth (each couple will have at least one partner under 30 years of age), parenting a~     newborn, and psychological aggression in the past year.~      The project has the following aims: (1) Determine the outcomes of Couple CARE for Parents.~     The investigators hypothesize that, among other positive outcomes, couples who receive~     Couple CARE for Parents, compared with those who do not, will report at follow-up (a) less~     IPV; and (b) less partner physical and emotional aggression. (2) Identify factors that may~     contribute to reduction in IPV and in physical and emotional aggression (e.g., communication~     skills, conflict behaviors, parenting expectations, , quality of adult attachment, partner~     attributions, child abuse potential, family income, marital status, parenting stress, infant~     difficultness).~   "
80103|NCT02008942|"~     This study will determine if aspirin from PL2200, an investigational product, gets into the~     blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to~     prevent blood clots as effectively as enteric coated aspirin, when administered to patients~     with diabetes~   "
80104|NCT02008929|"~     To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative~     liver resection on the patient with advanced HCC who has high risk of recurrence.~   "
80105|NCT02008916|"~     The purpose of this study is to generate 16-week efficacy data, as well as up to 3-year~     efficacy, safety and tolerability data in subjects with active AS despite current or~     previous NSAID, DMARD and/or anti-TNF therapy.~   "
80380|NCT02004340|"~     The purpose of this study is to determine whether transcutaneous auricular vagus nerve~     stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.~   "
80091|NCT02009098|"~     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum~     infections compared to women undergoing vaginal delivery. In Denmark the incidence of~     post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract~     infections (UTI) and wound infections (WI).~      Prophylactic antibiotics are effective in preventing postoperative infections and national~     guidelines recommend that antibiotics should be administered as a single dose immediately~     before surgical incision. CS is an exception to this pre-incision administration approach.~     National guidelines recommend administration of antibiotics after umbilical cord clamping to~     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic~     prophylaxis for CS suggest that prophylactic antibiotics administered before incision~     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two~     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on~     the baby and on late infection in the mother.~      This study is a double-blinded randomized controlled trial with a concurrent Health Economic~     Assessment. The study will examine the effect of change in timing of prophylactic~     antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The study will be~     performed at the obstetric departments at Odense University Hospital (OUH), Hvidovre~     Hospital (HH) and Hospital South West Jutland (HSWJ) in collaboration with the Department of~     Clinical Microbiology, OUH, to ensure that the most appropriate antibiotic regime is used.~     Furthermore, collaboration with a neonatologist will ensure appropriate assessment of~     neonatal outcome.~      The investigators plan to enroll the first patient at OUH February 2013. HH and HSWJ will~     follow with a couple of months delay. The inclusion period is scheduled to last until the~     investigators have 2844 participants, who have answered the questionnaire. The investigators~     expect to complete the inclusion period in October 2014 (last patient last visit, LPLV).~     Microbiological analyzes and data processing is expected to be completed one year after the~     LPLV. The study population is all women delivering a child by CS during the project period,~     at Department of Gynaecology and Obstetrics of OUH, HH and HSWJ.~      Objective: Investigate whether and by how much antibiotics administered 15-60 minutes before~     incision versus after umbilical cord clamping reduces the rate of postpartum infections in a~     Danish population of women undergoing CS.~      Hypothesis: Antibiotics administered pre-incision will result in fewer postoperative~     infections than antibiotics administered after the umbilical cord is cut.~      Hypothesis: Antibiotics administered before incision are cost-effective, compared to~     administration after umbilical cord clamping, measured by post-CS infection and as cost per~     Quality Adjusted Life Year (QALY).~   "
80092|NCT02009085|"~     In this study a fluorescent contrast dye is applied to a suspicious skin lesion.~      Images are acquired and processed. The information is used to develop a prediction model for~     the presence of malignant transformation in the skin.~   "
80093|NCT02009072|"~     Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical~     management techniques and high rate of post-operative recurrence. The investigators aim was~     to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in~     management of primary pterygium.~   "
80094|NCT02009059|"~     In pre-hospital care, there are few non-invasive thermometers that are proved both robust~     and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal~     based thermometer on patients undergoing thoracic surgery in deep hypothermia.~   "
80095|NCT02009046|"~     This study examines the effectiveness of the Sexuality Education Initiative (SEI), a~     comprehensive, multi-component, rights-based sexuality education program developed and~     implemented by Planned Parenthood Los Angeles for high school students. The primary goal of~     the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high~     schools. The SEI consists of four intervention components: (1) a 12-session~     gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer~     education and advocacy component, (3) a parent education component, and (4) clinical~     services linkages. It is hypothesized that the 12-session classroom curriculum is more~     effective than a 3-session control sex education curriculum. It is also hypothesized that~     the full SEI package (all four components) is more effective than the control condition~     (control curriculum and clinical services only).~   "
80096|NCT02009033|"~     The purpose of this study is to investigate the effect of thin fluid with starch versus thin~     fluid without starch on coagulation in elective surgery when the patient is normovolæmic~     during operation.~   "
80097|NCT02009020|"~     Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse~     pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med~     2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz~     technique, a non-invasive measurement device is now available commercially. In this study,~     the reference technique based on arterial measurement and a respiratory variation monitor~     (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a~     clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure~     and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1:~     307-10)~   "
80098|NCT02009007|"~     Liberal fluid administration is one of risk factors of developing acute lung injury (ALI) in~     thoracic surgery. Therefore, the investigators try to restrain fluid administration, and in~     the case of intraoperative hypotension, the investigators often administer vasoactive agents~     or inotropes. One lung ventilation (OLV) which is routinely employed for thoracic surgery~     decrease arterial oxygenation and oxygen delivery to brain can be also decreased. In this~     study, the investigators compared dopamine and phenylephrine in respect to maintaining~     cerebral oxygen saturation in major thoracic surgery. The investigators hypothesis is that~     dopamine is better than phenylephrine to maintain cerebral oxygen saturation in thoracic~     surgery.~   "
80099|NCT02008994|"~     Genes are the basic instruction book for the cells that make up our bodies and are made~     out of DNA. Many research studies are done to find the best possible way to treat patients~     with cancer. Recently there has been a great deal of interest in developing new anticancer~     agents that are more targeted to a patient's individual genetic information, as well as~     diseases caused by defects in a person's genes.~      Identification of precisely which treatments to use against a specific patient's tumor is~     challenging. In this study, four cutting-edge technologies will be used to identify genomic~     (information we get from DNA and RNA) and proteomic (information we get from proteins)~     targets for the treatment of your tumor. These four tests will be used together to gather~     information about your tumor giving doctors and scientists a better understanding of the~     structure of your tumor and what the best treatment or combination of treatments may be for~     you. The therapy you receive to treat your tumor will be based on your medical history,~     previous treatments for your disease if applicable, current state of health, and the~     findings from these four tests. The therapy you ultimately receive will be selected by your~     doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment~     Selection Committee).~   "
80100|NCT02008981|"~     This is a research study on the effect of some commonly used blood activating herbal~     products on platelet function and coagulation profile, ie whether it causes an increase in~     bleeding tendency, either used alone or in combination with Aspirin which is a commonly used~     anti-platelet drug.~   "
80410|NCT02005211|"~     This study consists of two parts, ie, single dose part with young healthy subjects (Part 1)~     and single and multiple dose part with elderly healthy subjects (Part 2), to assess the~     safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and~     multiple ascending dose administration to healthy subjects.~   "
80106|NCT02008903|"~     The overall goal of this study is to develop a novel minimally invasive device, the~     Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare~     disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner.~      This study is broken down into 2 specific aims:~      Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and~     specificity of the EST for documenting esophageal inflammation in a 1-hour time point.~      Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a~     1-hour sampling time.~      Funding Source - FDA OOPD~   "
80107|NCT02008890|"~     Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate~     to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar~     pustulosis Psoriasis Area and Severity Index 75 response rate~   "
80108|NCT02008877|"~     Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended~     dose of ganetespib when administered in combination with sirolimus in patients with~     refractory or relapsed sarcomas including unresectable or metastatic sporadic or~     neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed.~      Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for~     patients with unresectable or metastatic sporadic or NF1 associated MPNST.~   "
80109|NCT02008864|"~     Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in~     patients with end stage renal disease. It affect up to 90 percent of patients with end stage~     renal disease. Several hypotheses have been postulated for the possible underlying etiology,~     but none is conclusive. Aside from kidney transplantation, which is only definitive~     treatment, therapeutic approaches have largely been empirical, and no firm evident‐base~     treatments are available. The main goal of therapy remains to minimize severity of pruritus.~     In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In~     this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus~     by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna~     L. may attenuate uremic pruritus by decreasing serum IL‐2, IFN-γ and TNF‐α.~   "
80110|NCT02008851|"~     The purpose of this study is to determine if selected renal cells, obtained by biopsy from a~     patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can~     be safely implanted back into the patient.~   "
80111|NCT02008838|"~     To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid~     profile in subjects with metabolic syndrome, in a randomized, double-blind,~     placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented~     with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1)~     and the placebo (G2) groups will be advised to follow an energy balanced diet and physical~     activity recommendations. Parameters related to metabolic syndrome and insulin resistance~     will be measured every 7 weeks during the study course.~   "
80112|NCT02008825|"~     We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG~     will:~        1. enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent~          of gastric volume to be removed;~        2. increase the safety profile of the patient (i.e., reduce the likelihood of accidental~          stapling of the orogastric tube or bougie);~        3. reduce the incidence of OR contamination/infection transmission;~        4. streamline OR workflow, resulting in reduced OR time; and~        5. ensure consistent and reproducible staple lines.~   "
80113|NCT02008812|"~     To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the~     investigators conduct a prospective clinical study. In comparison with results from direct~     sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor ,~     including reproducibility, sensitivity, specificity, and cross-reaction. The potential~     factors which may interfere with the results would be investigated. With such technique, the~     investigators hope to make early diagnosis and give Adenovirus patients early treatment to~     reduce the complications and case-fatality rate.~   "
80114|NCT02008799|"~     Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately~     1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy~     reveals that these men have Sertoli cell-only pattern, maturation arrest, or~     hypospermatogenesis. Until recently, it was assumed that men with non-obstructive~     azoospermia were untreatable. Indeed, these patients were often referred to as being~     sterile or having testicular failure. We start to use stem cell in treatment of such~     patients by injecting the stem cell at the testis and the testicular artery in one group and~     at the testis only in other group~   "
80115|NCT02008786|"~     An emerging cause of heart attack in young women is a dissection (or tear) in the coronary~     arteries. Many of these young women continue to have chest pain long after the tear has~     healed and this is thought to be due to problems with their small blood vessels of the heart~     (or microcirculation). We want to determine whether commonly used medications for coronary~     artery disease including statins (for cholesterol) and angiotensin-converting enzyme~     inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these~     patients.~   "
80116|NCT02008773|"~     The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in~     comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working~     (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who~     are HSV-1 positive and early in the course of schizophrenia.~      We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1~     negative, will demonstrate significant valacyclovir efficacy for visual and working memory.~   "
80117|NCT02008760|"~     The aim of this project is investigation of patients' with chronic pain self-rated quality~     of life, ADL function and level of pain before and after 3 months of intervention with N-3~     fatty acids from krill in combination with vitamin D3. Furthermore, the compliance of the~     patients and the effect of the intervention on the patients' vitamin D status and~     cardiovascular risk factors are studied.~   "
80118|NCT02008747|"~     Atrial fibrillation and chronic neuropathic pain are adverse events occurring after~     posterolateral thoracotomy for lung resection. The continuous application of magnesium~     sulphate may have a prophylactic effect. The investigators record the incidence of atrial~     fibrillation during a seven day period after thoracotomy as well as the incidence of chronic~     neuropathic pain during a three months period, comparing one group with a continuous~     application of magnesium sulphate against one group without magnesium sulphate.~   "
80119|NCT02008734|"~     This is a Phase II study trying to identify whether short term treatment with PD0332991~     yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at~     surgery- or induces senescence as determined by SABG expression (IHC) in tumors from~     patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or~     chemotherapy, as compared to no treatment.~   "
80120|NCT02008721|"~     MSA is a rapidly progressive disorder with an average survival time of about 7 years after~     the first clinical manifestation. No potent symptomatic treatment is currently available. A~     disease-modifying therapy does not exist either. The growing understanding in recent years~     of the underlying pathological mechanisms of the disease allows the development of new~     treatment options that have a modifying effect on the disease progression. Therefore,~     treatments are urgently required that effect the central underlying pathological mechanism,~     which appears to be the intracellular aggregation of toxic oligomers of α-synuclein.~      EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic~     α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic~     oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models~     of PD and is an antioxidant and iron chelator. There are currently 63 clinical studies~     (http://clinicaltrial.gov) in which EGCG was applied for various indications, such as~     Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have~     shown good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day,~     demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for~     hepatotoxicity in uncontrolled conditions).~      These data provide a solid rationale for testing in a clinical trial if supplementation of~     EGCG can interfere with the core disease mechanism in MSA and consequently retard the~     clinical progression of the MSA-related disability.~   "
80121|NCT02008708|"~     The objective is to test the effectiveness of a village-led microfinance program, Pigs for~     Peace, on health, household economic stability, and reintegration of trauma survivors to~     family and community.~      The five-year experimental trial will use mixed-methods to address the following aims:~        1. Determine the effectiveness of a village-led microfinance program on participants~          health and reintegration in intervention households compared to participants in delayed~          control households. Health and reintegration will be measured at baseline and six,~          twelve, and 18-months post-baseline using self-report in both intervention and delayed~          control groups. We hypothesize that at six, twelve and 18 months post-baseline~          participants in intervention households will have improved health and increased~          reintegration to families in comparison to participants in control households.~        2. Determine the effectiveness of a village-led microfinance program on household economic~          stability in intervention households compared to delayed control villages. Household~          economic stability will be measured at baseline and six, twelve and 18 months post-~          baseline using self-report in both intervention and control households. We hypothesize~          that at six, twelve and 18-months post-baseline the intervention households will have~          improved household economic stability in comparison to control households.~        3. Examine the role of a village-led microfinance program on village-level health,~          economics, stigma and reintegration of survivors and their families in intervention and~          delayed control villages. Village members (n=5 in each village, n=50 total) will~          complete a baseline and 18 month post-baseline qualitative interview to examine the~          role of microfinance on village-level health, economics, stigma and reintegration in~          both intervention and control households.~   "
80122|NCT02008695|"~     The investigators will test the effectiveness of a youth-led animal husbandry microfinance~     program, Rabbits for Resilience, combined with the adult microfinance, Pigs for Peace (PFP),~     program on youth, family and community resilience outcomes. The following aims will be~     completed over the five-year longitudinal, mixed-method, cluster randomized community trial:~      Specific Aim 1: Determine the relative effectiveness of a youth-led microfinance combined~     with the adult microfinance on youth and family resilience outcomes (reduced mental health~     distress, increased economic stability, improved family functioning) compared to a youth-led~     microfinance only and adult microfinance only approaches.~        -  We hypothesize that at six, twelve and 18-months post-baseline youth and adults in~          households in the youth-led and adult microfinance approach will report improved~          individual and family resilience outcomes compared to households in the youth-led~          microfinance only and adult microfinance only approaches.~      Specific Aim 2: Determine the relative effectiveness of a youth-led microfinance combined~     with PFP microfinance on community resilience (e.g. social capital and participation in~     community groups by youth and adults) compared to youth-led microfinance only and adult~     microfinance only approaches.~        -  We hypothesize that at 18-months post baseline in households in the youth-led and adult~          microfinance will report improved community resilience compared to households in the~          youth-led microfinance only and adult microfinance only approaches~      Specific Aim 3: Determine if changes in youth resilience (caregiving ability, empathy and~     outlook for the future) mediate the relationship between youth engagement in microfinance~     and outcomes, as measured by reduced mental health distress, improved family functioning and~     improved social capital.~      Specific Aim 4: Examine youth perspectives on resilience in the context of multiple~     adversities (war, poverty, loss of family, displacement, victimization). Youth participants~     (N=50, ages 10-15 years) will be invited (with parent/caregiver consent) to complete at~     baseline and 18 month post-baseline qualitative interview/group discussion to examine~     individual, family and community resilience and what that they perceive as key to buffering~     the negative health and social consequences of prolonged conflict and other adversities.~   "
80123|NCT02008682|"~     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and~     safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese~     subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible~     subjects will continue their metformin background treatment during the trial.~   "
80124|NCT02008669|"~     Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of~     disability after injury accidents in young adults. Among the many symptoms, fatigue is very~     common with a significant impact on quality of life. Also, the disability caused by multiple~     sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as~     proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often~     deficient in this population with consequences in physical performance such as endurance and~     muscle strength. We propose to study the link between fatigue and shortcomings encountered~     in a defined population of MS patients.~   "
80125|NCT02008656|"~     The study is designed to test the hypothesis that patients with Locally advanced rectal~     cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision~     (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival~     (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT),~     Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).~   "
80126|NCT02008643|"~     The number of studies concerning health related quality of life (HRQL) in children with food~     allergy is very limited.~      Only one study to date has compared HRQL of a group of children with food allergy to data~     published on general population and other chronic diseases. This study concluded to lowest~     HRQL scores in food allergic children compared to type 1 diabetes mellitus with important~     impact on scores concerning social activities.~   "
80138|NCT02008487|"~     This study will test a special powder for ulcers caused by a variety of conditions such as~     pressure that sometimes happen when a person is at the end of life. The powder will be~     applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People~     who are being cared for by hospice or palliative care organizations will be invited to be in~     the study. The study will also find out if the powder is easy to use by caregivers as well~     as improving the comfort and quality of life of the person who has the ulcer.~   "
80139|NCT02008474|"~     The purpose of this study is to examine different types of monetary incentive paradigms for~     weight loss.~   "
80140|NCT02008461|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus~     botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were~     assessed with the use of an implanted monitoring device (IMD).~   "
80411|NCT02005198|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess the minimal important difference (MID) of the TRIM-AGHD.~   "
80127|NCT02008630|"~     The overall research aim of this study is to investigate changes in measures related to the~     risk of falls among elderly with dementia participating in animal-assisted interventions.~     Also relatives' experience of own and the elderly's situation during and after the~     intervention will be examined. The design will be a prospective and cluster randomized~     multicenter trial, but mixed-methods will be used to target different outcomes. The study~     population will be elderly (age above 65) at day care centers diagnosed with dementia, or~     having a cognitive deficit. The intervention will consist of 30 minutes sessions with~     animal-assisted activity or animal-assisted therapy two times a week for 12 weeks in groups~     of 4-6 participants. Control groups will receive treatment as usual. Research questions:~        1. Is there an effect in use of ordinary and optional medication among elderly persons~          with dementia at day care centers participating in animal-assisted interventions~          compared to a control group?~        2. Is there an effect on social interaction, quality of life, activeness and wellbeing~          among elderly persons with dementia at day care centers participating in~          animal-assisted interventions compared to a control group?~        3. Is there an effect on balance among elderly persons with dementia at day care centers~          participating in animal-assisted therapy compared to animal-assisted activity or a~          control group?~        4. Do relatives of elderly persons with dementia at day care centers experience a change~          in their own and the elderly's situation after the intervention compared with before~          the intervention started?~   "
80128|NCT02008617|"~     Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide~     analgesia for the front of the knee. Postoperatively, these patients will often report pain~     in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee~     results in blockade of the genicular nerves of the posterior knee. These nerves originate~     off of the tibial and common peroneal nerves and their blockade will result in improved~     posterior knee pain relief and may decrease narcotic consumption compared to patients who~     receive the same infiltration with normal saline.~   "
80129|NCT02008604|"~     The aim of the study is to verify the hypothesis that the microbial colonisation of the gut~     is changed in patients after stroke and that the gut microbiome of severely affected stroke~     patients differs from that of patients with only a short disruption of blood circulation in~     the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in~     stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of~     stroke-associated changes in the microbiome with immunological parameters will be analyzed.~   "
80130|NCT02008591|"~     The primary objective of this study is to compare the onset and duration of the initial dose~     of medications given through three different epidural (conventional epidural, combined~     spinal epidural and dural puncture epidural) techniques for labor pain relief.~      The secondary objective of this study is to compare the fetal effects of these three~     epidural labor analgesia techniques.~   "
80131|NCT02008578|"~     The purpose of this randomized, double-blind, placebo-controlled trial of intravenous~     hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine~     the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed~     following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform~     a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.~   "
80132|NCT02008565|"~     The study is a multi-center, randomized, placebo controlled trial with participants~     randomized into one of four groups:~        1. placebo/usual care (educational pamphlet)~        2. loperamide/usual care (educational pamphlet)~        3. placebo/anal exercises with biofeedback~        4. loperamide/anal exercises with biofeedback~      The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be~     compared between treatment groups using linear regression.~   "
80133|NCT02008552|"~     More than 5 million persons in France exposed, in last years, to the taking of the~     Benfluorex.~      Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks~     Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients~     developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were~     exposed during years without developing the slightest anomaly.~      The hypothesis is the existence of a particular genetic susceptibility at the patients~     having developed a valvulopathy continuation in the exposure in this medicine.~      Existence of one varying genetics with strong effect. The purpose is to identify involved~     genetic factors.~   "
80134|NCT02008539|"~     To evaluate the safety and tolerability of MSC_apceth_101.~   "
80135|NCT02008526|"~     Participants receive culturally relevant and specifically tailored text messages based on~     the behavioral change theoretical constructs of Social Support Theory, Health Belief Model,~     and Social Cognitive Theory. Participants are randomized into one of three conditions for an~     8-week intervention period: Group 1: culturally relevant theory-based text messages~     interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same~     culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or,~     Group 3: assessment-only (AO) control with no theoretically based text messages.~     Participants in all three conditions receive brief weekly text-message assessments on their~     methamphetamine use and HIV sexual behaviors in the previous seven days. Data related to~     intervention costs as well as relative exposure to each theoretical construct will be~     examined to determine cost- and mechanism-effectiveness, respectively. The randomized~     three-group design uses repeated assessments at baseline, at the end of the 8-week~     intervention period, and at 3-, 6-, and 9-month post randomization follow-up. This study~     will determine the differential immediate and sustained effects of transmitting theory-based~     text messages by PHE (TXT-PHE) versus by automation (TXT-Auto), compared to an~     assessment-only (AO) control condition among out-of-treatment, methamphetamine-using MSM for~     reductions of methamphetamine use and HIV sexual risk behaviors. It is hypothesized that~     there will be significantly greater reductions in methamphetamine use and HIV sexual risk~     behaviors from text messages transmitted by PHE than by text messages transmitted by~     automation, which in turn will produce significantly greater reductions than the AO~     condition (PHE > TXT > AO). In addition, this study will determine the cost-effectiveness of~     TXT-PHE vs. TXT-Auto compared to AO for reducing methamphetamine use and HIV sexual risk~     behaviors. The investigators hypothesize that the TXT-PHE intervention will prove more~     cost-effective than TXT-Auto in reducing methamphetamine use and HIV sexual risk behaviors,~     while the TXT-Auto condition will prove more cost effective than the AO condition in~     reducing these same outcomes (PHE > TXT > AO).~   "
80136|NCT02008513|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02~     vaccinations in patients with Alzheimer's disease. Patients, who have already participated~     in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation~     in the clinical trial is 19 months.~   "
80137|NCT02008500|"~     Aim of this study was to assess and compare the efficacy of a commercially available novel~     herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to~     a placebo and non herbal potassium nitrate over a period of 12 weeks.~   "
80141|NCT02008448|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, PVI plus linear~     lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients~     with persistent or longstanding persistent AF. Results were assessed with the use of an~     implanted monitoring device (IMD).~   "
80142|NCT02008435|"~     The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in~     overweight and obese individuals (e.g., 7% average loss of body weight), and thereby~     reducing the risk of developing weight-related health consequences. One-on-one DPP sessions,~     however, are costly and the group-delivered DPP version, the Group Lifestyle Balance program~     (GLB), is less effective (4% average loss of body weight). The aim of this two-arm parallel~     randomized controlled trial is to increase the effectiveness of the GLB by integrating habit~     formation techniques, namely if-then plans and their mental practice, into the program. The~     study will provide evidence-based data on the effectiveness of an enhanced GLB intervention~     in promoting weight loss and in reducing weight-related risk factors for chronic health~     problems.~   "
80143|NCT02008422|"~     The primary objectives of this control, single-center clinical study of EndostarTM Injection~     with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical~     response rate of Endostar injection concomitant with SOX on patients with advanced gastric~     cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety~     and tolerance of Endostar injection, while the secondary objectives were to observe the~     influence of Endostar injection on chemotherapy-induced adverse reactions and evaluate the~     overall survival time of EndostarTM injection concomitant with SOX on patients with advanced~     gastric cancer by evaluating the response rate (RR) clinical benefit rate (CBR),~     progression-free survival (PFS) and overall survival (OS).~   "
80144|NCT02008409|"~     The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as~     an internal laparoscopic liver retraction device. The secondary goals of the study are to~     evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver~     retraction device and to identify 'best practices' for device utilization.~      This study evaluates the use of a specific type of liver retractor (EndoLift). Liver~     retractors are often necessary during MIS procedures, but this retractor is the only device~     which is deployed internally (NOT requiring additional skin punctures/incisions for~     placement of the liver retractor device). All patients undergoing minimally invasive surgery~     (MIS) at Duke Regional Hospital will be approached.~      The new device is expected to have a minimal risk safety profile. The investigators believe~     that these risks are no more than would be encountered by using any other commercially~     available retraction device available on the market today. Data will be collected and~     analyzed by the identified investigators. Continuous variables will be analyzed via T-test~     and Chi-square analysis will be applied to discontinuous variables. Statistical analysis~     software such as SPSS® will be utilized when necessary.~   "
80145|NCT02008396|"~     This randomized, double-blind study is intended to test the safety and feasibility of using~     3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, compared with placebo, to treat~     social anxiety in autistic adults. Subjects will be randomly (by chance) assigned to receive~     placebo or MDMA during two experimental sessions. The first six subjects in the study will~     be randomized to placebo (2) or 75 mg MDMA on the first session and 100 mg MDMA on the~     second session (4). The next six subjects will be randomized to placebo (2) or 100 mg MDMA~     on the first session and 125 mg MDMA on the second session (4). The study will explore~     whether two doses of MDMA, combined with selected therapeutic activities, can reduce social~     anxiety. The study takes place in Los Angeles, California and requires about 15 visits to~     the study location over several months. Study subjects will meet with the investigators~     three times to prepare for the MDMA sessions, and they will meet with them on three~     occasions and receive daily phone calls for safety monitoring for a week after each session.~     Blood samples will be collected at baseline, two hours after drug administration during the~     second experimental session, one month and six months after the second experimental session~     to measure amounts of the hormones oxytocin, arginine vasopressin and cortisol in plasma.~     Subjects will return six months after their second experimental session for measurements of~     and social anxiety and other symptoms and an interview. Subjects will learn what they~     received at this visit. Subjects who received placebo can go through treatment again to have~     two sessions with MDMA, the first with 75 mg and the second with 125mg MDMA. Social anxiety,~     anxiety, depression, stress, self-esteem, empathy, and quality of life will be measured~     before and after experimental sessions.~   "
80146|NCT02008383|"~     There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2)~     the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the~     Combination Dose Finding cohort and the Combination Expansion cohort, we will combine~     cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer~     (CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET~     gene amplification (MET amplification). Patients with MET amplification will receive~     cabozantinib only (monotherapy).~      The primary objective of this open-label phase Ib trial are:~        1. To determine the maximum tolerated dose and the recommended phase II dose for the~          combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic~          colorectal cancer and~        2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients~          with prospectively identified MET amplified metastatic colorectal cancer.~      The secondary objectives are:~        1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab.~        2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab.~        3. To describe the safety and tolerability of cabozantinib monotherapy in patients with~          MET amplified colorectal cancer.~        4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients~          with MET amplified colorectal cancer.~   "
80147|NCT02008370|"~     The investigators are presently using Exparel, a slow released local anesthestic, in~     patients undergoing minimally invasive cardiac surgery. The primary objective of this study~     is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube~     sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive~     cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by~     the subject's overall postoperative pain scores and postsurgical analgesic use.~   "
80148|NCT02008357|"~     The purpose of this study is to test whether an investigational drug called solanezumab can~     slow the progression of memory problems associated with brain amyloid (protein that forms~     plaques in the brains of people with Alzheimer Disease [AD]).~   "
80149|NCT02008344|"~     The purpose of this study is to determine if favipiravir is effective in reducing the time~     to resolution of influenza symptoms.~   "
80150|NCT02008331|"~     The interest on gastrointestinal (GI) dysfunction in CKD has been growing in the last years.~     it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic~     microinflammation by promoting gut dysbiosis and bacterial translocation in the blood.~     Another mechanism by which GI dysfunction contributes to systemic symptoms in CKD is related~     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to~     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has~     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in~     CKD. In the present paper the investigators investigated the effect of a probiotic/prebiotic~     mixture on plasma p-cresol concentrations and GI symptoms and in CKD patients not on~     dialysis yet.~   "
80151|NCT02008318|"~     The purpose of this study is to investigate the effect of the study drug known as LY2157299~     on red blood cells in participants with myelodysplastic syndromes (MDS). Participants with~     different degrees of disease (very low, low, and intermediate risk) will be studied. The~     study treatment is expected to last about 6 months for each participant.~   "
80152|NCT02008305|"~     Interventional Neuroradiology replaces surgery. This technology requires various exposition~     to X rays : number of X rays photographs, radioscopy, distance between patient and detector,~     speed of acquisition of X-rays photographs, high tension and intensity.~      The manipulator must find the right balance between quality of photographs and dose~     delivered to the patient (optimization).~      Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and~     long life expectancy with risks. So, it is fundamental to optimize the dose delivered during~     the procedures.~      The investigators propose to analyse a study comparing two protocols of optimization of~     doses. The investigators' hypothesis is that the protocol experimented in this trial allows~     less radiation of the children, compared to the usual protocol.~   "
80153|NCT02008292|"~     The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in~     endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in~     schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced~     elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for~     the binding of the radioligand. We hypothesize there will be greater increase in ACh level~     (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking~     subjects. We hypothesize there will be greater increase in ACh level (or greater reduction~     in radio tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia,~     but the extent of this change will be different than in controls.~      We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in~     healthy smoking and nonsmoking subjects before and after amphetamine challenge.~   "
80154|NCT02008279|"~     The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated~     in both Japanese and Caucasian men as well as to understand how the body absorbs and removes~     the study drug after being injected or infused into the body.~   "
80155|NCT02008266|"~     This non-interventional, descriptive, cross-sectional and multicenter study will examine the~     treatment of rheumatoid arthritis progressing for less than two years in the Algerian~     population. Current drug therapy as well as disease status and patient function will be~     assessed.~   "
80156|NCT02008253|"~     To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation~     to correct keratoconus on eyes with prior refractive surgery.~   "
80157|NCT02008240|"~     The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided~     aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with~     ultrasound visible hydrosalpinges undergoing IVF-ET.~   "
80158|NCT02008227|"~     This global, multicenter, open-label, randomized, controlled study will evaluate the~     efficacy and safety of Atezolizumab compared with docetaxel in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) after failure with~     platinum-containing chemotherapy. Patients will be randomized 1:1 to receive either~     docetaxel (75 mg/m2 intravenous infusion) or Atezolizumab (1200 mg intravenous infusion)~     every three weeks. Treatment may continue as long as patients are experiencing clinical~     benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or~     symptomatic deterioration attributed to disease progression.~   "
80159|NCT02008214|"~     Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a~     (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on~     54 to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected~     patients. A previous study on HCV monoinfected patients showed that the addition of~     pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased~     SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV~     coinfected patients.~      On the other hand, other factors such as host genetics, have proved to influence treatment~     response on HCV infected patients. The best described genetic factor so far is the~     interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype~     provides an almost twice increase on SVR than the rest of the genotypes.~      Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline~     addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV~     genotype 1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism~     rs12979860.~      HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy~     (HAART), with at least 8 months on undetectable HIV viral load and T helper cells count of~     200 or higher will be included. Patients will be randomized on one of two groups:~        -  Group A: IFN alpha 2a + RBV + PTX~        -  Group B: IFN alpha 2a + RBV + placebo~      Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks~     (for non rapid responses). Outcome measures will be the following:~        -  SVR rate 24 weeks after the end of treatment~        -  Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient~          elastography and the AST to platelet ratio index (APRI index)~        -  IL28B rs12979860 genotype~      The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a~     and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate~     and fibrosis progression irrespectively of IL28B rs12979860 genotype.~   "
80160|NCT02008201|"~     The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a~     group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the~     effect that supplementation may have during the course of a year.~      The study is a double blinded parallel study design.~   "
80161|NCT02008188|"~     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for~     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate~     the system's ability to significantly improve blood glucose levels. This protocol represents~     a culmination of prior clinical trials in development of this AAA control system and~     benefits from the synthesis of those components.~   "
80412|NCT02005185|"~     Anesthesia for more than 120 minutes given to children less than 2 years of age without~     coexisting diseases of the central nervous system or the heart cause long-term impairment of~     recognition memory.~   "
80162|NCT02008175|"~     Keratoconus is a chronic progressive non - inflammatory disorder characterised by~     progressive steepening and thinning of cornea and high myopic astigmatism, accounting for~     poor visual acuity in such individuals. Keratoconus seems to be more advanced on~     presentation, in young patients.~      The investigators intend to evaluate the effectiveness of conventional collagen cross~     linking in young patients diagnosed with keratoconus.~   "
80163|NCT02008162|"~     To assess response to bronchodilation with tiotropium plus salbutamol in patients with~     severe emphysema and analyze relationships between bronchoreversibility response and~     semiquantitative computed-tomography based emphysema severity measures.~   "
80164|NCT02008149|"~     Following a complete spinal cord injury (SCI), individuals experience progressive bone loss,~     especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some~     point during their lifetime. Fractures following SCI are costly to treat and more than half~     of patients experience a medical complication, requiring extended hospitalization, resulting~     in a substantial impact on their quality of life. To reduce the incidence of fractures, more~     effective rehabilitation strategies to prevent bone loss are needed. The goal of this~     research is to determine if bone health can be preserved using an indoor rowing exercise~     program in which the leg muscles are electrically stimulated using several, small surface~     electrode pads that are placed on the skin on the front and back thigh muscles. An~     encouraging case study has recently shown remarkable bone preservation in one individual~     with SCI who participated in an electrical stimulation rowing program, however, whether~     other individuals with SCI can achieve the same benefit is currently unknown.~   "
80165|NCT02008136|"~     This protocol is a prospective, open label, pilot study examining the utility of three~     established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index~     (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI)~     as well as their relationship to three novel quantitative tools to measure the effect of~     botulinum toxin injections for neck pain and back pain. The three novel methods for~     measuring neurotoxin effect are: muscle twitch patterns using surface electromyography~     (sEMG), cervical and lumbar range of motion using a neck and low back inclinometer, and skin~     surface temperature readings using an infrared imaging camera.~   "
80166|NCT02008123|"~     The purpose of this study is to determine whether adding primidone will improve the~     metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and~     platelet response to clopidogrel in patients who were previously found to lack adequate~     response to clopidogrel. This information could help overcome clopidogrel resistance in~     patients who are at risk for stroke or transient ischemic attack (TIA).~   "
80167|NCT02008110|"~     Preliminary data suggest a potential role for monitoring and up-titrate pharmacological~     therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for~     acute heart failure (AHF).~      This study will evaluate the effect of a CA125-guided management strategy versus standard~     therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in~     patients recently discharged for AHF.~   "
80168|NCT02008097|"~     The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ~     E9 system in three clinical focus areas.~        1. Liver transplant patients: Improved real-time visualization of liver vessels is needed~          to improve diagnosis and assessment following stenting or angioplasty.~        2. Renal artery disease: Improved real-time visualization of the renal arteries would~          enable a more rapid and accurate assessment of renal artery disease (stenosis,~          dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal~          artery interventions.~        3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta~          perfusion and assay for potential ischemia.~   "
80169|NCT02008084|"~     The purpose of this pilot study is to learn what study factors are important in designing a~     large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and~     high-density lipoprotein cholesterol (HDL-C) levels. In this study, patients will first~     enter a Single-blind, dietary-controlled baseline period and receive 1000 mg placebo or~     active drug three times daily with meals (i.e., breakfast, lunch, and dinner) for 6 - 8~     weeks. If the qualify to continue, they will then receive up to 2000 mg of active or placebo~     drug for an additional 14 weeks. Active drug will be given to 48 patients and placebo drug~     will be given to 16 patients. However, neither the patients not the clinic staff will know~     which patients are on active or placebo drug until the end of the study.~   "
80170|NCT02008071|"~     The purpose of this study is to conduct a pilot randomized controlled trial, to determine~     whether providing financial incentives for meeting daily step goals (a) increases the daily~     step counts of participants, (b) increases compliance with the overall program (including~     diet recommendations), and (c) increases weight loss.~   "
80171|NCT02008058|"~     This is a single-arm observational longitudinal study in of patients with metastatic~     castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain~     and other symptoms.~   "
80172|NCT02008045|"~     The purpose of this study is to collect and compare information from cranial ultrasounds,~     magnetic resonance imaging scans, neurological exam and neuropsychological assessments of~     children. The investigators hope that the information collected in this study will help with~     early screening, diagnosis and treatment of brain injury in newborns as well as identify a~     connection between MR imaging (MRI-magnetic resonance imaging, MRS-magnetic resonance~     spectroscopy) and neurodevelopmental outcome.~   "
80173|NCT02008032|"~     Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast~     tomosynthesis) and conventional 2-D digital mammography devices with regards to patient~     comfort and radiologist preference in women with breast implants.~      Participants: Women with breast implants undergoing routine 2-D digital mammography.~      Procedures (methods): 50 female subjects with breast implants undergoing conventional~     screening mammography will be recruited to have a single view s-DBT in the mediolateral~     projection. We will perform a patient preference study and radiologist reader study composed~     of radiologists who have experience evaluating tomosynthesis images. A short survey will be~     given to each patient about their preference in modality with respect to comfort. Each~     reader will review the images and score the ease of interpretation, and their confidence of~     interpretation.~   "
87750|NCT01908764|"~     The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension~     following two posologies of bilateral ototopical doses in pediatric subjects immediately~     after bilateral tympanostomy tube surgery.~   "
80174|NCT02008019|"~     The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this~     is a rare occurrence, and patients with incomplete resection have very poor therapeutic~     options. In this context, it becomes important to find new therapeutic strategies to slow~     down tumor progression and to reduce tumor size before resection.~      Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and~     neo-adjuvant therapy in chondrosarcoma.~      Then, investigators propose a phase II, randomized, open label study compounded by 3 arms~     (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary~     or relapsed chondrosarcomas :~      ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.~      The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn~   "
80175|NCT02008006|"~     The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine,~     etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for~     first and second chemosensitive relapses in patients with follicular lymphoma (World Health~     Organisation (WHO) grade 1, 2, 3a).~   "
80176|NCT02007993|"~     The aim of the proposed controlled clinical trial is to evaluate the effect of photodynamic~     therapy (PDT) on the formation of volatile sulfur compounds (VSCs) from coated tongue and~     its action on the severity of halitosis in adolescents using different treatment protocols.~      HYPOTHESIS~        1. - Null hypothesis: There is no change in halitosis following the use of photodynamic~          therapy.~        2. - Experimental hypothesis: There is a reduction in halitosis following the use of~          photodynamic therapy alone or in combination with a tongue scraper.~   "
80177|NCT02007980|"~     The aim of this study is to identify the root cause for the significant discolouration of~     Boston Scientific Percuflex based stents.~   "
80178|NCT02007967|"~     The overall objective of this proposal is to examine the feasibility and accuracy of~     non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals~     referred for transcatheter aortic valve implantation (TAVI).~   "
80179|NCT02007954|"~     The purpose of this study is to determine the feasibility and safety of using small beads~     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat~     patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with~     doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE)~     DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to~     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows~     for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the~     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into~     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and~     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and~     blood tests (to include assessment of liver function and tumor markers) and by imaging~     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they~     will be exited from the study and followed for survival. Once exited from the study they~     will continue to be eligible to receive the smaller beads (DEBDOX), should it be~     recommended.~   "
80180|NCT02007941|"~     The purpose of this study is to assess between the renal impaired patients and normal renal~     function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When~     prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of~     instructions.~   "
80181|NCT02007928|"~     We propose a prospective multicenter study, whose originality lies in the inclusion of the~     naive child and adolescent population. Its purpose is to evaluate the incidence of adverse~     events related to the use of l antipsychotic drugs in children and adolescents with no~     history of taking such drugs.~      The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years,~     (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28~     days without taking antipsychotic before or with a history of antipsychotic over a maximum~     period of three consecutive months and discontinued for at least 6 months.~      Therapeutic monitoring during the 12 month study period will include clinical assessments~     and laboratory testing. These assessments will be performed before treatment (at inclusion),~     and at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.~   "
80182|NCT02007915|"~     To determine the safety and effectiveness of pamidronate in patients with radiographically~     proven avascular necrosis which are the result of unstable (acute) slipped capital femoral~     epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in~     nature.~   "
80183|NCT02007902|"~     The primary aim of this study is to investigate the relationship between early plasma~     protein levels and hemodynamics in very preterm infants during postnatal transition.~     Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting~     plasma protein level at birth; ii) to evaluate the relationship between plasma protein level~     and albumin level on the first day of life; iii) to evaluate the association between early~     hypoproteinemia and neonatal mortality and morbidity in very preterm infants.~   "
80184|NCT02007889|"~     Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux~     (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in~     treatment of acute infection.The pathogenesis of APN is related to bacterial~     virulenece,immune response,tissue factors,apoptosis and production of free radicals that~     lead to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical~     factor in the pathogenesis of pyelonephritis whereas pharmacological management of the~     oxidative stress response may provide a therapeutic effect in preventing renal pathologies.~     Animal model show that L-carnitine alleviated oxidative stress, and acute renal inflammatory~     injury can be prevented much more effectively by carnitine in addition to conventional~     antibiotic treatment in pyelonephritis.This study is a simple randomized clinical trial~     (RCT) evaluating the effect of L-carnitine in addition to antibiotic on preventing renal~     scaring after acute pyelonephritis in children. Simple non- blind randomized clinical trial~     on 78 patients in 2 groups (intervention & control) is conducted.Children aged 1 month to 10~     years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid~     (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis were enrolled into a~     clinical trial. Patients were excluded if they had neurogenic bladder, systemic~     hypertension, obstructive uropathy. Patients in Intervention group are administered 50~     mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic~     regimens and patients in control group received antibiotic regimens. Primary outcome is the~     development of renal scar by doing DMSA renal scan on the 7th day of admission and six~     months after the intervention and compared between groups and secondary outcome is the~     incidence and severity of pyelonephritis and response to treatment.~   "
80472|NCT02004106|"~     This open-label, multicenter, dose-escalation study with an expansion phase will evaluate~     the safety, pharmacokinetics and therapeutic activity of RO6895882 in patients with advanced~     and/or metastatic solid tumors. Patients will be treated until disease progression or~     unacceptable toxicity occurs, for up to a maximum of 24 months.~   "
80185|NCT02007876|"~     In this pilot study a group of older adults undergoing midline laparotomy for~     gastrointestinal malignancy will participate in a mobility and activity training (MAT)~     program. MAT is designed to advance functional mobility and physical activity and spans the~     pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery~     will be randomized to MAT versus control usual care and evaluated at their first appointment~     4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and~     6 weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT~     will show less decline and earlier recovery in functional activity, and trunk and thigh~     muscle strength mass. This study is uniquely innovative in that it links functional activity~     assessment and training and analysis of trunk morphomics (muscle mass) in exploring~     mechanisms of post-operative recovery. Results from this pilot will be used to determine an~     effect size for the recruitment of a larger cohort and to study key surgical outcomes,~     including surgical complications, operative symptoms, hospital length of stay, and cost of~     care.~   "
80186|NCT02007863|"~     Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality~     for patients with leukemia and myelodysplasia. UCB is now considered Standard Of Care in~     cases where a suitable living bone marrow donor is not available. The survival of UCB is~     similar to Matched Unrelated Marrow Transplant. This study is considered Research since~     UCB is not a licensed product and requires investigational new drug (IND). THERE ARE NO~     SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem~     cell treatment modality to pediatric patients who may require it after a conditioning~     regimen that excludes Total Body Irradiation.~   "
80187|NCT02007850|"~     Quadriceps muscle strength is an important determinant of quality of recovery in elderly~     patients after total knee arthroplasty. We try to compare the quadriceps muscle strength~     change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled~     femoral analgesia group.~   "
80188|NCT02007837|"~     Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major~     causes of maternal mortality worldwide, especially in low and middle income countries. This~     trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin~     D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced~     hypertension in women at risk. Secondary and tertiary objectives include other maternal and~     neonatal outcomes.~   "
80189|NCT02007824|"~     Study objective The purpose of this trial is to evaluate the efficacy and safety of the~     investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic~     wound.~   "
80190|NCT02007811|"~     The reconstitution of a functioning immune system after allogeneic stem cell transplantation~     takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the~     current conditioning regimes. During the period of intense immune suppression the patients~     are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The~     adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance~     humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy~     with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will~     evaluate the functionality of the transferred B-lymphocytes in the patient.~   "
80191|NCT02007798|"~     An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening,~     smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild~     pain, as well as better tolerance to endotracheal intubation can avoid can increased~     intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking,~     suffocation and agitation, and can reduce postoperative cerebral edema and the risk of~     bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients'~     neurologic function based on the excellent recovery from anesthesia. Up to now, there are~     many methods and drugs to improve the quality of recovery period, but each of them has some~     flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic~     recovery period, and cannot affect evaluation of neurological function with both the~     sedative and analgesic effects. We propose the following hypotheses: (1) A small dose of~     dexmedetomidine can be intravenously injected into patients subjected to craniotomy under~     general anesthesia, in order to improve the recovery profiles and reduce the incidence of~     emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.~   "
80192|NCT02007785|"~     The purpose of the study will be to determine the effects of the Cognitive Orientation to~     daily Occupational Performance (CO-OP) as a treatment program for individuals with~     Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on~     successful engagement in meaningful activities will be examined from participants' and~     live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived~     health-related quality of life and caregiver burden will also be evaluated.~      Hypotheses:~        1. Training with the CO-OP will have an effect or multiple effects on participation in~          meaningful activities and health-related quality of life for individuals with~          Parkinson's-related cognitive impairment.~        2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and~          health-related quality of life for caregivers of individuals with Parkinson's-related~          cognitive impairment.~   "
80193|NCT02007772|"~     The purpose of this trial ist to investigate the difference of the efficacy of two systems~     for breath support in patients with COPD.~   "
80194|NCT02007759|"~     The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation~     (NMES) will provide a more efficient method of treating neonates with dysfunctional oral~     feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates~     at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG)~     and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral~     feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.~   "
80222|NCT02007395|"~     Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality,~     due to its capability to detect and remove precancerous lesions. However, polypectomy is~     associated with complications, such as bleeding and perforation, with an estimated overall~     incidence of about 10%, with polyp size and right-sided location considered as major risk~     factors. Aim of present study was to prospectively evaluate the early and delayed (30-days~     follow-up) complications of polypectomy in a multicenter regional Italian real practice~     setting~   "
80195|NCT02007746|"~     Patients with sickle cell disease many have a number of systemic complications, including~     liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to~     chronic blood transfusions. The purpose of this study is to investigate FibroScan readings~     in patients with sickle cell disease and iron overload secondary to blood transfusions, and~     to correlate the FibroScan results with Ferriscan. A comparison with the results of~     FibroScan to patients with Sickle cell without known liver disease, who have never been on~     chronic transfusions and with normal liver function profiles will also be made.The primary~     hypothesis is that the results of FibroScan will correlate with the results of Ferriscan and~     liver biopsy.~   "
80196|NCT02007733|"~     Diarrhea is the second leading cause of death in children worldwide, and accurately~     assessing dehydration status remains a crucial step in preventing morbidity and mortality~     from this disease. While children with severe dehydration require immediate treatment with~     intravenous fluids, children with mild to moderate dehydration have a significant reduction~     in hospital length of stay and fewer adverse events when treated with relatively inexpensive~     oral rehydration solution (ORS). While several clinical scales have been developed for~     assessing dehydration in children, these scales have never been prospectively validated in a~     low-income country setting, where the vast majority of diarrhea morbidity and mortality~     occurs in children.~      The investigators hypothesize that new clinical and ultrasound-based tools will improve the~     diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing~     the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration~     as well as the adverse events and inappropriate utilization of scarce resources that occurs~     as a result of over-diagnosis of severe dehydration.~   "
80197|NCT02007720|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous~     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF)~     patients.~   "
80198|NCT02007707|"~     The goals of the study are to develop smoking cessation intervention using lay health worker~     (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in~     Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a~     two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108~     dyads of a smoker and a family member from the same household. The hypotheses are:~      H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive~     the proposed ―Quit Smoking For a Healthy Family Intervention, a Family-based Intervention~     (FI), will be more likely to achieve biochemically verified 7-day point prevalence of~     smoking abstinence when compared to those receiving an attention control intervention (CI).~      H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit~     attempt than those in CI.~      H3. At 6-month, FI participants will be more likely to report using a recommended~     evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation~     medications, advice from health professionals) than those in CI~   "
80199|NCT02007694|"~     Recent advances in animal research have identified pharmacological agents that appear to~     both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine~     hydrochloride (YOH). A finding in animal literature is that the administration of YOH during~     extinction trials accelerates fear reduction and may convert ineffective exposures in to~     successful ones. It is thought that the mechanism of enhanced emotional memory is through~     elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized~     controlled trial claustrophobic participants underwent exposure in combination with YOH or~     placebo. The YOH group showed significantly better results on anxiety improvement than the~     placebo group. In a more recent study with participants with fear of flying no additional~     benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these~     studies by enhancing the dose of YOH in combination with VRET and by extending our~     experimental design with another group which receives propranolol in combination with VRET.~     Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation~     in healthy humans. In this randomized controlled trial a between groups design is chosen to~     further characterize the differential within and between trial extinction and to enhance~     possible between groups effects. Sixty participants with fear of flying or fear of heights~     will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET~     plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered~     three sessions of VRET over a period of two weeks.~   "
80200|NCT02007681|"~     The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of~     time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for~     standing and walking behaviours would substantially increase total (TEE) and PA energy~     expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female~     overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk~     workers. Specifically using an experiment design our main aims are: a) to determine the~     impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting~     SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the~     determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE~     were dependent on specific covariates.~   "
80201|NCT02007668|"~     Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo~     Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive~     the correct application of the method described. The placebo group will receive a medical~     adhesive tape. The control group will not receive any form of intervention.~   "
80202|NCT02007655|"~     The primary objectives of this study are:~        -  To estimate the incidence rate of unexpected adverse events~        -  To characterize the bleeding events and assess risk factors of bleeding~        -  To identify ancillary baseline variables that may also be associated with adverse~          outcomes~   "
80203|NCT02007642|"~     The study patients are patients suffering from primary or secondary immunodeficiencies~     investigated in the Hospital Necker for a suspected infectious disease.~      The study purpose is to assess the performance of a High Throughput Sequencing method, the~     PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic~     diagnostic approach.~      The study will evaluate the capacity of the PATHOQUEST method to detect pathogens~     responsible for an infectious disease episode and will also evaluate the delay of obtention~     of results compared to the classic diagnostic approach.~   "
80204|NCT02007629|"~     BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and~     may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary~     arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved~     the right heart function without unacceptable side effects. Here dose of Riociguat will be~     adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary~     Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg~     Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on~     previous evidence and on the different modes of action an improvement of exercise capacity,~     heart function and quality of life may be expected if PDE5i treatment is transitioned to~     riociguat.~      Where Riociguat is pending market approval or reimbursement once the treatment phase is~     completed drug can be made available for another 18 months (Extended Drug Supply Phase -~     EDSP) under study conditions. Patients may also transition at the end of the maintenance~     period or any time during the EDSP to any program that is intended to provide riociguat~     until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or~     named patient program. Study termination is also possible at any time.~   "
80205|NCT02007616|"~     The ageing of the population will inevitably lead to a growing number of older people living~     alone and in need of care. Given the high cost of geriatric care, a critical research issue~     is exploring ways to improve or maintain cognitive and functional status in old age.~     Unfortunately, it has been shown that training those specific cognitive processes most~     sensitive to ageing (such as speed of processing or working memory), produces only limited~     beneficial effects. However, research also suggests that factors such as cognitive~     engagement, physical activity and social context may act as more general modulators of~     cognitive decline. This project is a longitudinal study with experimental and control~     groups. It is inspired from the engagement model of cognitive optimization suggesting that a~     lifestyle marked by social and intellectual engagement may mitigate age-related declines on~     cognitive functioning. It uses new cutting-edge information computing technology (ICT)~     solutions to improve or simply maintain cognitive functions in the elderly. This research~     investigates how the treatment reduces the effects of cognitive age-related decline in~     executive control processes and episodic (explicit) memory using behavioral and imaging~     measures. The results will provide significant knowledge on the potential of new ICT~     technologies to delay, compensate, and even prevent common chronic problems experienced by~     the elderly population. The hypothesis is that cognitive training with video-games through~     ICT solutions will promote brain and mental health and independence. Ultimately, the~     objective is to contribute to the understanding of factors that help avoiding the (personal~     and economic) consequences of long-term care in geriatric institutions.~   "
80206|NCT02007603|"~     The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam~     and amoxicillin/clavulanic acid during intermittent haemodialysis.~   "
80207|NCT02007590|"~     To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure,~     increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients~     with severe chronic obstructive pulmonary disease (COPD).~   "
80208|NCT02007577|"~     The possibility that obesity-associated inflammatory changes may play a role in the~     pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that~     salicylates might represent a useful treatment to improve glucose tolerance. Several~     studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have~     demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but~     have not led to a coherent view as to the mechanism(s) involved.~      In this research proposal we will use specific methods to quantify insulin mediated glucose~     uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance~     (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the~     insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers~     to identify those individuals who are sufficiently insulin resistant to be enrolled in this~     study. We will then use the graded glucose infusion technique in these insulin resistant~     subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline~     measurements, salsalate or placebo will be administered for one month to the participants,~     after which time the IST and the graded glucose infusion will be repeated to quantify and~     compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus~     placebo. These results will provide for the first time quantitative data of the effect of~     salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic~     individuals.~   "
80209|NCT02007564|"~     The research activities funded through PAR Dissemination and Implementation Research in~     Health in grant R21NR011112 Legacy Intervention Family Enactment (LIFE) have been varied~     and highly successful. The LIFE project was designed with three primary objectives. Aim 1~     was to assess the efficacy of LIFE as delivered by Retired Senior Volunteers (RSVs) on~     palliative care patients': (a) mood and emotional experience; (b) physical symptom burden;~     and (c) experience of meaning. Aim 2 was to assess the efficacy of LIFE as delivered by RSVs~     on one primary family caregiver's: (a) caregiving stress; (b) mood and emotional experience;~     and (c) experience of positive aspects of caregiving. Aim 3 was to assess the ability of~     RSVs to deliver LIFE effectively.~      Although hospice and palliative care social workers frequently use reminiscence and creative~     activities with their patients 16, such interventions need to be more accessible to patients~     and families transitioning from community, hospital, and palliative care settings. If~     hospice or palliative care is not chosen as a treatment option, few means of delivering~     therapeutic reminiscence-based interventions exist. This represents a significant gap in~     practice and in the psychosocial palliative care intervention literature. Kazdin and Blase~     (2011) argue cogently that the community need for mental health services far outstrips the~     number of providers available to assist those in distress. They call strongly for new~     intervention delivery modes targeting prevention and treatment to alleviate suffering.~     Hence, the purpose of the present study was to evaluate the effectiveness of retired senior~     volunteers (RSVs), who are available nationally through the National Senior Corp Program, to~     deliver a three-session reminiscence and creative activity intervention previously found~     effective in improving palliative care patient and caregiver outcomes (Allen, 2009; Allen,~     Hilgeman, Ege, Shuster, & Burgio, 2008). We hypothesized that palliative care patients and~     their caregivers in the RSV-delivered intervention group would demonstrate improved~     emotional and spiritual functioning relative to a supportive contact control group. If~     successful, this mode of treatment delivery (e.g., RSV intervention) would represent a~     significant step toward translation and greater access at earlier disease stages of~     therapeutic psychosocial interventions for individuals near the end of life and their family~     members.~   "
80210|NCT02007551|"~     The purpose of this study is to evaluate the impact of a psychosocial and nutritional~     intervention, entitled RelAte, on cooking and mealtime behaviours of older adults who are~     living alone and at risk of social isolation. The intervention will be delivered in the home~     of participants by a trained volunteer of a similar age.~   "
80473|NCT02004093|"~     This study will evaluate the efficacy and safety of pertuzumab in combination with~     carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent~     ovarian cancer. The anticipated time on study treatment is 3-12 months.~   "
80211|NCT02007538|"~     In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS),~     has an increasingly important role in the characterization of malignancy. The cytological~     sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine~     needle aspiration. Immunocytochemical staining allows not only to discriminate between small~     cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the~     expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a~     technique for cytological assay already validated and largely used in the immunocytochemical~     determination of gynaecologic specimens. Further Studies are required to asses the accuracy~     of this technique compared to conventional smear in cytological airway samples obtained by~     fine needle aspiration.~   "
80212|NCT02007525|"~     The investigators propose to pilot test a six-week yoga program among adults with peripheral~     arterial disease (PAD). Participants (n=50) will be randomized to a six-week yoga~     intervention (n=25) or wait-list control (n=25). The yoga intervention will include a weekly~     yoga class currently used among cardiac rehab patients at the University of Michigan Health~     System, together with home-based practice sessions. Participants will perform treadmill~     testing at baseline and 6 weeks to assess walking capacity. The primary outcomes of interest~     include 1) acceptability of the program by participants, 2) feasibility of recruitment, 3)~     change in maximal walking distance, 4) change in claudication symptoms, and 5) change in~     health-related quality of life (HRQOL). The investigators expect this will inform us on the~     acceptability and feasibility of a larger proposal examining yoga in PAD patients. These~     data will also inform on the effect size in maximal walking, and HRQOL, which will be used~     to estimate the sample size needed for a larger R01 level proposal.~      Study hypotheses:~      Hypothesis 1: Participants will find the yoga program acceptable with low drop-out rates~     (<15%), excellent attendance (>80% classes attended), and good completion of the home-based~     practice sessions (self-report >80% completed).~      Hypothesis 2: The yoga intervention will be feasible for a larger study based on numbers of~     potential participants approached, and those who consent to participate vs. those who do~     not.~      Hypothesis 3: Increases in maximal walking distance and pain-free walking distance (from~     baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention~     compared to the control group.~      Hypothesis 4: Self-reported claudication symptoms will be reduced to a greater degree (at 6~     weeks) among participants randomized to the yoga intervention compared to the control group.~      Hypothesis 5: Increases in HRQOL (from baseline to 6 weeks) will be greater in the~     participants randomized to the yoga intervention compared to the control group.~   "
80213|NCT02007512|"~     The purpose of this study is to determine if enzalutamide given in combination with~     exemestane is safe and effective in patients with advanced breast cancer.~   "
80214|NCT02007499|"~     The investigators hypothesized that pre-arrival instructions would increase the likelihood~     of bystanders performing Cardiopulmonary Resuscitation (CPR).~   "
80215|NCT02007486|"~     Dyspnea (breathlessness) on exertion is the most prevalent and distressing symptom of heart~     failure (HF). Nevertheless, the mechanisms of dyspnea in HF remain poorly understood. Thus,~     the general aim of this pilot study is to advance our understanding of the mechanisms of~     activity-related dyspnea in patients with HF. Studies will be performed in patients with~     mild, moderate and severe HF (n=24) as well as in healthy, age- and sex-matched control~     subjects (n=8). We will test the hypothesis that the increased prevalence and severity of~     activity-related dyspnea in HF reflects the interaction between an exaggerated drive to~     breathe and the inability of the respiratory system to meet this increased demand. Detailed~     physiological and perceptual responses to bicycle exercise will be examined and compared,~     first, between HF patients and healthy control subjects and, second, across patients with~     varying degrees of HF severity. The results from this preliminary study will be used to help~     design future studies in this patient population.~   "
80216|NCT02007473|"~     The objective of this non-interventional study is to gather data on adverse reactions~     occurring with Methylene Blue plasma administered in a routine clinical practice~     environment; to know more about their characteristics and behaviour and the possible factors~     that may influence their presentation and evolution.~   "
80217|NCT02007460|"~     Osteoporotic fractures are an extremely common and serious public health issue which~     contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines~     in bone strength combined with an increase risk of falls (associated with decline in~     muscular function with age) are the main determinants of fracture risk. Exercise that is~     novel and involves impact loading has the potential to improve bone strength and~     neuromuscular function (strength, power and balance). It is thus imperative to evaluate~     potential benefits of exercise in older people. The musculoskeletal responses to exercise~     may also be influenced by vitamin D status. It is the purpose of this study to consider the~     influence of a one year unilateral (one limb) high impact exercise programme on~     musculoskeletal health, specifically bone structure, muscle strength and power in older~     caucasian men. It is also the purpose of this study to determine whether this differs~     according to vitamin D status. The findings will reveal whether exercise can improve bone~     health and/or neuromuscular function, and whether improvements are dependent upon vitamin D~     status.~   "
80218|NCT02007447|"~     This study is design to evaluate the influence of oxytocin in some aspects of Autism~     Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills,~     quality of life and disruptive behaviors.~      Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive~     behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills,~     quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with~     the use of oxytocin.~   "
80219|NCT02007434|"~     The objectives of this study are to determine the safety of deoxycholic acid subcutaneous~     (SC) injections in the submental area and to evaluate the effects of four interventions,~     relative to placebo in the submental area, particularly with regard to assessment and~     management of pain, bruising, and swelling/edema.~   "
80220|NCT02007421|"~     SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of~     human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more~     than 90% of anal cancer.~      Gay men are over 20 times more likely than others to develop anal cancer.~      SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will~     provide important information to guide the possible future introduction of anal cancer~     screening programs for gay men.~   "
80221|NCT02007408|"~     Objective: The investigators sought to investigate the analgesic efficiency of lidocaine~     spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray~     combination in patients undergoing first-trimester surgical abortion.~      Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108~     women with the request of pregnancy termination.The subjects were randomly assigned into~     four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and~     placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard~     Visual Analog Scale (VAS).~   "
80474|NCT02004080|"~     CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury~     (TBI) care in the ICU setting~   "
80223|NCT02007369|"~     According to the Census & Statistics Department, there are still 659,300 daily smokers~     (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers~     to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but~     they could not maintain abstinence. Relapse prevention is aimed at providing interventions~     to prevent relapse after starting the abstinence status. This pilot single-blind randomized~     controlled trial (proof of concept study) will test the effectiveness of social networking~     services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for~     a qualitative interview for the design of intervention. Then, the pilot-RCT trial will~     recruit 120 participants who have recently quitted smoking, and they will be randomly~     allocated to 2 intervention groups and one control group. The 2 intervention groups will be~     arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group~     moderators and sharing quitting experience with other participants. All participants will~     receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3~     months and 6 months. The primary outcome is the self-report relapse rate (Relapse is~     tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT~     among the 3 study arms.~   "
80224|NCT02007356|"~     To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed~     virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent~     infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment~     refractory post-transplant viral infections. The CCS has already been successfully used in~     clinical studies in Germany and United Kingdom (UK).~   "
80225|NCT02007343|"~     This study aims to assess how large an additional disease burden and what extra costs are~     generated by antibiotic resistance in patients suffering from infections caused by~     gram-negative bacteria, such as Escherichia coli and Pseudomonas aeruginosa, in hospitals in~     the Netherlands.~   "
80226|NCT02007330|"~     Systemic lidocaine administration may improve postoperative pain and recovery after~     laparoscopic inguinal hernia repair in pediatric patients~   "
80227|NCT02007317|"~     This study is single-arm, none randomized, open label, two-dose-cohorts, single center~     clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in~     patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the~     planned surgical excision of the lesion.~   "
80228|NCT02007304|"~     The purpose of is to determine the preventive effects of Chinese herb supplement with panax~     ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness~     and vascular reactivity by using a double-blind randomized control design and to examine the~     effects of a 12-week progressive eccentric resistance exercise training on arterial~     elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate~     arterial stiffening effects elicited by exercise-induced inflammation and improve~     endothelial function.~   "
80229|NCT02007291|"~     Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related~     disorders, such as Alzheimer's disease (AD), warrant special attention due to their high~     prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase~     inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and~     long-term.~      However, clinical response is heterogeneous and needs further investigation. Objective: To~     investigate the rate of response to ChEI in AD after three months of treatment. Methods:~     Patients with mild or moderate dementia due to probable AD or to AD associated with~     cerebrovascular disease were included in the study.~   "
80230|NCT02007278|"~     The purpose of this study is to compare the effect of a fixed dose combination of~     vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in~     glycemic variability in patients with type 2 diabetes who have not achieved adequate control~     of their disease prior to treatment with metformin monotherapy in optimal doses.~   "
80231|NCT02007265|"~     The purpose of this study is to determine whether simple, evidence-based clinical screening~     be quickly and feasibly implemented (>85% of patients in an average of <6 minutes) in~     large-volume urgent transient ischemic attack (TIA)/stroke clinics to identify individuals~     at high risk for the three most common and devastating post-stroke co-morbidities~     (depression, obstructive sleep apnea and cognitive disorders).~   "
80232|NCT02007252|"~     This study was designed to assess the safety, tolerability and efficacy of ACZ885 on~     aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the~     study was to provide data to enable decisions regarding the further development of ACZ885~     for subjects with abdominal aortic aneurysms. The design of this study addressed the primary~     objective of evaluating the change in aneurysmal size in subjects with AAA as a result of~     treatment with ACZ885.~   "
80233|NCT02007239|"~     This study seeks to determine the efficacy of tocilizumab (TCZ) in patients with~     hemophagocytic lymphohistiocytosis (HLH) and high cytokine levels (proteins involved in~     inflammation) in an attempt to decrease the damage caused by these proteins; and secondarily~     to assess its safety and impact on disease activity.~   "
80234|NCT02007226|"~     Although conventional risk factors for coronary heart disease (CHD) have been identified and~     routinely used to determine risk for CHD in the general population, a systematic approach to~     determine population-specific risk for CHD has not been performed prospectively in those~     with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages~     than in the able-bodied population. Conventional risk factors for CHD are high serum~     concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density~     lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family~     history of premature CHD.~      Coronary Artery calcification (CAC) is a commonly occurring phenomenon that does not~     necessarily indicate significant obstructive disease. Studies have shown that a strong~     association exists between coronary calcification and coronary heart disease. The purpose of~     this study is to compare the CAC scores in persons with SCI with a historical control group~     of able-bodied persons from a national data base who will be matched for conventional risk~     factors for coronary artery disease (CAD) and to determine the relationship between CAC~     scores and conventional and emerging risk factors for CAD. Additionally, postprandial~     lipemic (elevated levels of lipids following ingestion of food) responses among individuals~     with SCI and control subjects will be compared, as well as the response of inflammatory~     markers following a high fat meal. Participants will only be tested once for these~     parameters.~   "
80235|NCT02007213|"~     Patient reported outcomes (PROs) instruments are often used to measure meaningful treatment~     benefit or risk in clinical trials. PROs allow patients voices to be heard in ways that~     assist healthcare clinicians to address treatment effects and individual patient~     preferences. Unfortunately, infants and young children, especially those with a debilitating~     disease, such as neuromuscular disorders (NMD), may be less able to provide clear and~     concise information about treatment effects. In this case, we often defer to parents and~     guardians (to be referred to collectively as parents throughout protocol) to provide their~     perception of their child s overall health and wellbeing. Including parents in the~     assessment process recognizes the unique knowledge parents have of their child s~     development, reinforces their central role in implementing interventions, and aids in their~     ability to make better-informed healthcare decisions [1]. Yet, most parent-reports for young~     children are confined to overall quality of life (QoL). While QoL is an important area of~     assessment, its meaning varies among different ages and populations, and its results are~     often not precise enough to reveal small differences within samples [2]. A more specific~     area of concern in children with NMD is early-onset muscle weakness leading to difficulties~     in motor function.~      The current lack of patient-centered, sensitive measures (based on motor function and item~     difficulty hierarchy) that are suited for repeated assessments in infants and young children~     with NMD represents a major obstacle to the rapid translation of promising therapeutic~     interventions from preclinical models to clinical research studies. Multiple clinical~     outcome measures used at a single time-point for capturing a child s functional status are~     burdensome, difficult to interpret and do not provide us with comprehensive, meaningful~     information to detect changes following an intervention [3]. Psychometric measures that can~     be completed by parents make it possible to collect a considerable amount of data over many~     time-points rather than being limited to a single clinical observation. Moreover, a~     parent-observational measure that focuses on their child s functional performance in their~     real-life will maximize the ecological validity of measures of motor development used for~     clinical trials.~      Objective: To develop a parent reported observational measure of motor development in~     infants and young children, which will serve as a complimentary tool to clinical observation~     by reporting motor function as observed in the home setting and which will be used in~     clinical trials.~      Study population: Parents of children aged 0-5 with neuromuscular disease and neuromuscular~     experts in pediatrics.~      Design: Qualitative (parent interviews, focus groups) and quantitative study (analysis of~     newly developed questionnaire)~      Outcome Measures: parental responses to phone interviews, neuromuscular expert responses to~     focus groups, parental responses to cognitive interviews, validity and reliability of newly~     developed questionnaire~   "
80238|NCT02007174|"~     Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to~     treat abnormal vascular conditions of the anterior segment of the eye. In pterygium,~     anti-VEGF agents have been recently proposed as primary treatments, such as perioperative~     adjuvants, as well as treatments for pterygia recurrences after surgery. The aim of the~     present study was to prospectively evaluate the effect of three subconjunctival bevacizumab~     injections in patients with an early pterygium recurrence. Materials and Methods: The~     current study was a non-randomized single central trial. The method of ensuring allocation~     concealment was sequentially numbered. Patients with an early pterygium recurrence were~     selected and invited to participate in the study. Recurrence was defined as the presence of~     corneal vessels with concomitant conjunctival hyperemia within the first trimester after~     primary pterygium removal, and only patients with primary pterygium recurrence were~     included. Patient related factors such as pregnancy, women seeking to become pregnant, and~     lactating women were excluded from the study. All patients received three subconjunctival~     bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the~     pterygium, and were photographed at the third, sixth and twelfth months after the last~     bevacizumab injection. Photographic analyses were performed taking into account two~     pterygium areas: the first measure included only the vessel area in the corneal surface,~     while the second measure included, both, conjunctival and corneal vessel area~     (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was~     determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in~     order to get pixels measurements of the lesion.~   "
80239|NCT02007161|"~     Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of~     healthy volunteers.~   "
80240|NCT02007148|"~     Second-line chemotherapy represents an option in gastric cancer, especially for patients~     with adequate performance status. Two randomized phase III trials comparing 2nd-line~     docetaxel with best-supportive care have reported a benefit in favor of chemotherapy.~     Capecitabine is a fluoropyrimidine carbamate, which has a broader spectrum of antitumor~     activity than other fluoropyrimidines. In gastric cancer xenografts. metronomic capecitabine~     inhibited angiogenesis, growth of gastric cancer and improved survival with less toxicity.~     Given its potential low toxicity, the combination of docetaxel and metronomic capecitabine~     needs to be evaluated to assess efficacy and tolerability in patients with advanced gastric~     cancer previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.~   "
80241|NCT02007135|"~     The purpose of this study is to determine the concurrent validity of a newly developed~     pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator~     in the stimulation of muscle proprioceptors.~   "
80242|NCT02007122|"~     The study will be conducted to investigate the pharmacokinetics of ceftaroline during~     continuous and intermittent renal replacement therapy.~   "
80243|NCT02007109|"~     Pediatric research in the management of nausea has been limited by the absence of a reliable~     method to quantify the intensity of this subjective symptom. In adults, the visual analog~     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young~     children. A scale is a series of points made on a line that will be used for measurement; a~     mark on the far left of the line shows little pain and the mark on the far right means alot~     of pain.~   "
80244|NCT02007096|"~     The purpose of this study is to determine if a Transabdominal Plane Block will decrease~     patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical,~     incisional) hernia repair with mesh.~   "
80245|NCT02007083|"~     Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a~     compression of the the neural and vascular structures in the spinal canal. This often gives~     neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today~     the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical~     treatment is well documented by several clinical trials, and a Cochrane review article from~     2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical~     solution is to decompress the stenotic part of the lumbar spine. There is no consensus in~     the literature of which surgical method that gives best long term clinical results. The~     investigators are therefore planning a Randomized Controlled Trial, where they will compare~     clinical and radiological results of three different surgical methods for LSS. The main~     outcome of this study is to answer which surgical method that gives the best long term~     clinical results. And, secondary outcome is to find out how much increase of the Dural Sac~     Cross Sectional Area is needed to give a long time relief of the patients` symptoms.~   "
80246|NCT02007070|"~     This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in~     participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for~     programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab~     will result in a clinically meaningful Overall Response Rate (ORR).~   "
80247|NCT02007057|"~     Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The~     postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic~     surgery but does not provide a satisfactory postoperative analgesia . The locoregional~     anesthesia is recommended and includes several techniques: the interscalene nerve block, the~     suprascapular nerve block, intra-articular injection of local anesthetic and subacromial~     infiltration. The interscalene nerve block is currently the gold standard for anesthesia and~     postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% .~     However it must be carried out by teams experienced in the locoregional anesthesia because~     it is operator -dependent. The suprascapular nerve block is a simple technique that can be~     performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less~     invasive than the interscalene nerve block and exposing the patient to fewer complications.~     However, his interest was not assessed in the repair of tendons of the rotator cuff. The~     main hypothesis of this study is that the suprascapular nerve block is as effective as the~     interscalene nerve block in the prevention of early postoperative pain after arthroscopic~     repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the~     analgesic consumption while reducing the risk of complications related to regional~     anesthesia.~   "
80248|NCT02007044|"~     The goal of this clinical research study is to learn if the combination of ibrutinib and~     rituximab can help to control CLL better than ibrutinib alone. The safety of these~     treatments will be also studied.~   "
80249|NCT02007031|"~     Wintertime is associated with increased morbidity and mortality and a majority is related to~     cardiovascular causes, such as myocardial infarctions, heart failures, and strokes. It is~     also known, that both acute and long-term cold exposure increase blood pressure and cardiac~     workload, and this may contribute to the observed excess morbidity and mortality during the~     cold season.~      Although the effects of cold on blood pressure are known among healthy people, these~     responses among risk groups, such as hypertensive people, are not established. In addition,~     changes in cardiac electrical activity or autonomic regulation are largely unknown. The~     cardiovascular responses in the cold could be different among hypertensive people because of~     disturbances in the circulatory regulation or function, such as aortic stiffening and~     increased vasomotor tone of peripheral arteries due to endothelial dysfunction associated~     with the disease. To assess this, a controlled experiment employing a cold exposure similar~     to everyday winter circumstances in a subarctic climate was performed.~   "
80250|NCT02007018|"~     The purpose of this study is to determine, in patients who undergo an elective colorectal~     resection through a midline laparotomy incision, whether the use of negative pressure wound~     therapy (NPWT) applied to the site of the laparotomy compared to standard care alone,~     reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively.~     The investigators hypothesize that the use of NPWT will reduce the rate of postoperative~     SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and~     return visits related to SSI.~   "
80251|NCT02007005|"~     The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of~     abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder~     cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor~     remission and the influence on the one-year recurrence rate.~   "
80252|NCT02006992|"~     Effects on weight and weight gain will be monitored in healthy term infants fed assigned~     infant formulas.~   "
80253|NCT02006979|"~     In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to~     treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study~     will investigate whether this finding translates to human breast cancer patients.~     Participants scheduled to receive chemotherapy for breast cancer will be randomized to~     exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on~     cardiac function will be compared between groups noninvasively by echocardiography and~     electrocardiography and a venous blood draw at baseline before chemotherapy, after the first~     treatment and at the end of chemotherapy.~   "
80254|NCT02006966|"~     Systemic lidocaine infusion may improve the patients' chronic post surgical pain after~     video-assisted thoracic surgery~   "
80255|NCT02006953|"~     The purpose of this study is to determine the best way to feed children after they have a~     gastrostomy tube placed. The study compares bolus feeding to continuous feeding.~   "
80256|NCT02006940|"~     The study is devoted to the comparative analysis of the data received in patients with lung~     pathology using new method of probe-based confocal laser endoscopy of distal airways and two~     reference methods: high resolution computed tomography and morphology.~   "
80257|NCT02006927|"~     The goal of this study is to evaluate electrical stimulation of nerves responsible for~     erectile function after surgery to remove the prostate (prostatectomy). Electrical~     stimulation of the nerves responsible for erectile function is experimental. The~     investigators hypothesize that the subjects can tolerate nerve stimulation.~   "
80258|NCT02006914|"~     This research is to investigate the nutritional supplement chromium picolinate. The~     investigators are testing to see how effective this supplement is in treating insulin~     resistance associated with HIV disease.~   "
80259|NCT02006901|"~     Introduction: This observational study is designed to test the equivalence between the~     clinical effectiveness of microdecompression and laminectomy in the surgical treatment of~     central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for~     spinal surgery in the elderly, and as the oldest segment of the population continues to grow~     its prevalence is likely to increase. However, data on surgical outcomes are limited. Open~     or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy,~     was formerly the standard treatment. In recent years a growing tendency towards less~     invasive decompressive procedures has emerged. Many spine surgeons today perform~     microdecompression for central lumbar spinal stenosis.~      Prospectively registered treatment and outcome data are obtained from the Norwegian Registry~     for Spine Surgery (NORspine).~   "
80260|NCT02006888|"~     The purpose of this study is to determine whether IBI-10090 injection is effective in the~     treatment of inflammation associated with cataract surgery.~   "
80261|NCT02006875|"~     To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is~     getting a popular idea. Previous studies seemed to support its effects on facilitating motor~     recovery after stroke. This study focuses on the motor recovery of lower extremities.~     Investigators conducted the study to evaluate the treatment effect of rTMS on the functional~     performance of lower extremities in terms of postural control, balance, and mobility in~     stroke patients. Investigators hypothesized that these performances could be improved~     through the better motor control of lower extremities caused by rTMS.~   "
80262|NCT02006862|"~     This clinical observational study aims to investigate the efficacy of olanzapine (Villamos~     ®) in accordance with the instructions attached thereto in standard clinical practice,~     followed by the physician to the patient.~      This is a multicenter, non- interventional observational study , 6-month period without~     preparing the patient to take the usual his medication . A total of 3 scheduled visits :~     Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end~     of treatment) .~      The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients~     who are indicated . Will be monitored and recorded all the different concomitant therapy .~     The treatment of each patient is an individual designated by the physician , according to~     standard clinical practice and without any intervention research purpose .~      During the six months of observation patients visit the clinic at the beginning (day 0 ),~     intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly~     monitored by their doctor for senile dementia and their behavior .~   "
87751|NCT01908751|"~     The purpose of this study is to determine the impact of surgical fixation (cancellous screws~     versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient~     important outcomes.~   "
80265|NCT02006823|"~     This study will explore ways to improve the effectiveness of patient Self Management at a~     time when genetic test results guide new treatments that will dramatically increase the~     possibility of cure of the hepatitis C virus.The study will also focus on the interactions~     between provider and patients and the ways that technical work, adaptive work and adaptive~     leadership foster patient self-management.This proposed 2 year exploratory mixed-methods 12~     longitudinal case study will explore patients' and providers' explanations for how and why~     they engage in technical work, adaptive work, and adaptive leadership and the ways in which~     these strategies promote or pose barriers to patients' self-management of Chronic Hepatitis~     C in the context of the new genetic test results and treatments. Specific aims are to:~      1: Examine how technical work, adaptive work and adaptive leadership influence patients'~     perceptions of their likelihood of cure and how this work relates to self-management during~     12 to 24 weeks of treatment for Chronic Hepatitis C. Research questions are: 1.1) How do~     patients describe their interactions with the providers? 1.2) How do these interactions~     shape patients' perceptions of the likelihood of cure? 1.3) How do patients' understanding~     of their interactions with the provider promote the use of or pose barriers to~     self-management during treatment?~      AIM 2: Describe providers' use of technical work, and adaptive leadership approaches during~     clinical encounters,to include nurse education visits. Research questions are:~      2.1) What technical work, and adaptive leadership approaches do providers use when sharing~     treatment information with patients during the clinical encounters. 2.2) What explanations~     do providers give for how and why they use technical work and adaptive leadership~     approaches? AIM 3: Describe the trajectories of illness perceptions(Control/Cure sub-scale -~     Illness Perception Scale), symptoms (M.D. Anderson Symptom Inventory) , viral load, and~     self-management (Patient Activation Measure) in relation to patient and provider reports of~     technical work, adaptive work, and adaptive leadership from the index clinical encounter to~     the follow-up treatment response encounter (ranging from 12 to 24 weeks).~   "
80266|NCT02006810|"~     The main objective is to develop and validate new endothelial function markers~     discriminating and reproducible by assessing the ability to reveal changes in endothelial~     function in response to positive and negative nutritional stimuli.~   "
80267|NCT02006797|"~     This study will evaluate the impact of a communication between hospital pharmacist and~     community pharmacists in addition to drugs reconciliation procedure at discharge. It will be~     conducted in 21 french public hospitals.~   "
80268|NCT02006784|"~     This is an open label, pilot, observational, prospective study of the safety of inactivated~     influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted~     during the 2013-2014 influenza season. The study will test conventional and novel biomarkers~     to assess disease flare and vaccine response and will also collect self-reported~     signs/symptoms in reactogenicity diaries during the 14 days after vaccination.~   "
80269|NCT02006771|"~     This one-year randomized crossover study is proposed to compare the changes of postprandial~     oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese~     adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of~     POS differ with meals from different cultures. Four cultural meals are chosen, namely~     Southern Chinese, Northern Chinese, American, and South Indian, based on the known~     prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the~     Southern and Northern Chinese population.~   "
80270|NCT02006758|"~     The purpose of this observational study is to further evaluate the safety and performance of~     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled~     hypertension in clinical routine practice.~   "
80271|NCT02006745|"~     The purpose of the study is to explore the treatment of patients with acute hepatitis C~     infection (infection acquired within the last 6 months) who are also infected with human~     immunodeficiency virus (HIV).~   "
80272|NCT02006732|"~     The objective of this study is to assess the efficacy and safety of 12 weeks once daily~     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat~     inhaler) compared with tiotropium and placebo in patients with COPD.~   "
80273|NCT02006719|"~     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of~     AA4500 in the treatment of adhesive capsulitis.~   "
80274|NCT02006706|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in~     patients with active rheumatoid arthritis who have had an inadequate response to at least 1~     DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15,~     and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12~     months.~   "
80275|NCT02006693|"~     The objective of this study is to evaluate the AqueSys XEN Implant for the treatment of~     moderate primary open angle glaucoma patients when medications have failed to control~     intraocular pressure (IOP). Effectiveness will be evaluated by comparing medicated~     preoperative, intraocular pressure to postoperative values. Additionally, the number of IOP~     lowering medications subjects are on at each study visit will be compared to preoperative~     medication.~   "
80276|NCT02006680|"~     The best way to measure whether treatment of children with central precocious puberty is~     working is to do a hormone stimulation test (leuprolide stimulation test) that requires~     injection of a medication and multiple blood draws to see if the hormonal response is~     suppressed (blocked). The hypothesis of this study is that random measurement of the free~     alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that~     stimulate puberty, will provide an adequate alternative to the leuprolide stimulation~     testfor monitoring efficacy of pubertal suppression with Supprelin LA®.~   "
80277|NCT02006667|"~     This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous~     Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The~     anticipated time on study treatment is until disease progression.~   "
80278|NCT02006654|"~     To establish efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors~     (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).~   "
80279|NCT02006641|"~     To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic~     treatment of patients with mild-to-moderate Alzheimer's disease (AD).~   "
80280|NCT02006628|"~     A study to compare the change in symptom severity in patients with schizophrenia or related~     psychotic disorder when treated with GWP42003 or placebo, added to existing anti-psychotic~     therapy over a period of six weeks. Secondary objectives are to evaluate the effect of~     GWP42003 on quality of life and cognition and to assess the safety and tolerability of~     GWP42003.~   "
80281|NCT02006615|"~     We hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield~     ability to upregulate the function of primary motor cortex and prefrontal cortex that play~     key roles in motor and frontal memory processing.~   "
80339|NCT02005848|"~     A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the~     Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New~     Onset Type-1 Diabetes.~      The study objectives are:~        -  To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes~        -  To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes~          pediatric and young adult population.~   "
80282|NCT02006602|"~     This will be an open-label, randomized, single dose, two-way crossover study. Each subject~     will participate in both treatment periods and will receive single oral doses of candesartan~     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods~     will be separated by a washout period of at least 7 days and no greater than 14 days. This~     study aims to determine the relative bioavailability of a 16mg test formulation tablet of~     candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan~     cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca~     group of companies.~   "
80283|NCT02006589|"~     This will be an open-label, randomized, single dose, two-way crossover study. Each subject~     will participate in both treatment periods and will receive single oral doses of candesartan~     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods~     will be separated by a washout period of at least 7 days and no greater than 14 days. This~     study aims to determine the relative bioavailability of an 8mg test formulation tablet of~     candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan~     cilexetil in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca~     group of companies.~   "
80284|NCT02006576|"~     The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently~     available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower~     respiratory tract and if this results in improvement in measures of lung repair function.~   "
80285|NCT02006563|"~     -  Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging~          (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose~          delivery in the treatment of brain tumors.~        -  If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is~          related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion~          is located in the MTV area that is outside of the CTV.~        -  Alternatively, if CTV > MTV, then the difference in volumes is related to higher~          treatment toxicity.~   "
80286|NCT02006550|"~     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out~     normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory~     suggests that most tumors undergo a process of differentiation through which a relatively~     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of~     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result~     of this cellular diversity, one or more cells within the tumor are likely to be resistant to~     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key~     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the~     original intervention. The cellular programs driving the uncontrolled proliferation of many~     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in~     CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs~     will be effective in the treatment of cancer. The investigators' research program focuses on~     the elucidation of signaling mechanisms, control of cellular processes and discovery of~     small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are~     fundamental to CSCs. Our preliminary results identified a novel Notch associated protein~     NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed~     in human solid tumors and is required for cell survival and tumor growth in notch -dependent~     tumor cells. The investigators' aim is to further interrogate the link between Notch and~     Nack.~   "
80287|NCT02006537|"~     This study will investigate the safety and pharmacokinetics (PK) of a single dose of~     GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and~     age on drug exposure. The biliary metabolites in healthy young males will be investigated~     using the Entero-test after a single oral dose of GSK2256294. This study will be conducted~     in two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the~     PK profile of GSK2256294 in healthy young males and also to investigate the biliary~     metabolites of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK~     parameters of GSK2256294 between in the fed and fasted state within subject and also to~     compare the PK parameters of GSK2256294 between male and female subjects. A washout period~     of a minimum of 2 weeks has been chosen to allow and adequate washout of GSK2256294.~   "
80288|NCT02006524|"~     Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and~     treated in time with anticoagulants, many disabling strokes can be prevented. In order to~     improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly~     and easy to use stick that diagnoses atrial fibrillation in one minute. During influenza~     vaccination, many patients who are also at risk for atrial fibrillation visit the general~     practice. This offers an ideal opportunity for screening for atrial fibrillation. The study~     investigates the yield of screening for atrial fibrillation with the MyDiagnostick during~     influenza vaccination (newly detected atrial fibrillation with corresponding CHA2DS2-Vasc~     score).~   "
80289|NCT02006511|"~     Wound complications associated with surgical incisions range from minor to life threatening.~     Surgical site infections occurring usually occur within 30 days and are one of the most~     common surgical complications. Perigraft infections in groin wounds can be devastating. Even~     superficial wounds can progress to deep wounds resulting in graft infection, need for~     explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had~     favorable results on closed wounds in trauma populations. Similarly, negative pressure wound~     therapy has had positive benefits in closed incisions such as sternal wounds following~     cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to~     allow easier application of negative pressure therapy to closed wounds. Application of the~     PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure~     (VAC®) therapy with the added benefits of protecting the wound from contamination and~     bolstering the wound edges for better approximation and consequently better aesthetic~     outcome. However, no comparison between negative pressure therapy as a dressing and standard~     wound dressings exists.~      The purpose of this study is to assess the efficacy and safety of topical negative pressure~     therapy application with Prevena™ versus standard of care wound therapy on closed groin~     incisions in high risk patients undergoing vascular surgery.~   "
80290|NCT02006498|"~     This is a randomised study to examine whether high dose Sillymarin will be able to help~     improve fat-induced liver damage in the liver. The study hypothesis is that high dose~     Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better~     than placebo.~   "
80295|NCT02006433|"~     The Investigators propose an investigation of the safety of deep brain stimulation (DBS) for~     the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI).~      Aim 1 is to determine whether DBS in the periaqueductal/periventricular gray region~     (PAG/PVG) of the brain at analgesic intensities produces any systemic or neurological~     adverse effects in patients with longstanding SCI (>1 year), either immediately or as a~     result of prolonged application for up 40 weeks.~      Aim 2 is to determine whether acute application of DBS in the PAG/PVG influences the~     severity of spontaneous ongoing pain caused by longstanding SCI.~      Aim 3 is to determine whether DBS in the PAG/PVG affects stimulus-evoked or persistent~     hypertension (a major sign of autonomic dysreflexia) in chronic SCI patients.~      Aim 4 is to determine whether prolonged PAG/PVG stimulation (for 40 weeks) leads to~     cumulative changes in chronic pain severity or in the motor or autonomic symptoms of chronic~     SCI patients.~   "
80296|NCT02006420|"~     Scleroderma as well as numerous other rheumatologic conditions can affect the skin.~     Scleroderma in particular involves skin thickening and hardening. Currently, evaluation of~     skin involvement by scleroderma is assessed based on a combination of physical examination~     and histologic assessment after biopsy. The investigators propose to measure skin hardness~     using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear~     wave velocity imaging (ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to~     distinguish normal skin from skin affected by scleroderma (and other rheumatologic~     conditions) as well as perhaps quantify the amount of fibrosis in the dermis. Such a~     radiologic biomarker could be used to help confirm the diagnosis of scleroderma as well as~     to follow patients over time and assess response to therapy and progression of disease.~   "
80297|NCT02006407|"~     This is a pilot study to assess the changes in white matter, in the brain, in response to~     radiation therapy and correlate these changes with later declines in cognitive function.~   "
80298|NCT02006394|"~     Clinical and rodent studies have demonstrated the impact of specific dietary factors in~     modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and~     cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and~     glycemic index. The investigators know from previous studies in the literature that reducing~     the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results~     in improved metabolic indices and reduced inflammation. These improvements can be observed~     even within the context of persistent obesity. The investigators will implement a~     reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and~     reducing inflammation in obese subjects with the metabolic syndrome. The active diet will~     include reduced glycemic index foods together with omega-3 fats and polyphenol supplements.~     The primary hypothesis is that the dietary combination of reduced glycemic index foods,~     omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more~     efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese~     subjects with the metabolic syndrome.~   "
80299|NCT02006381|"~     Measuring basal levels of plasma oxytocin in individuals with typical development across~     childhood and adolescence using both extracted and unextracted EIA methods.~   "
80300|NCT02006368|"~     The purpose of this study is to determine the life span and functional characteristics of~     platelets derived from whole blood that has been stored in a refrigerator for up to 21 days.~     Currently, platelets are separated from red cells shortly after donation and stored at room~     temperature for no longer than 5 days. This study is considered experimental because; 1) we~     will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2)~     we will be reinfusing a small portion of that donation back into the study-subject-donor and~     tracking how many of the transfused platelets from that unit circulate in the~     study-subject-donor in the hours and days after transfusion.~   "
80301|NCT02006355|"~     This study aims at comparing continuous local anesthesia and femoral nerve bloc for total~     knee arthroplasty in terms of post-operative recovery.~   "
80302|NCT02006342|"~     To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with~     intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement~     for ICU admission compared to IV insulin with delayed administration of SQ glargine for the~     treatment of DKA.~   "
80303|NCT02006329|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver dysfunction~     worldwide. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and in turn to~     cirrhosis. To date, the detailed pathogenic mechanism of NAFLD including steatosis and NASH~     is not fully characterized, although it is regarded as a hepatic manifestation of the~     metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. Based on~     conventional models of two-hit and multi- hit hypothesis of NAFLD, the dysregulated~     lipid metabolism and insulin resistance are considered as the first hit of the liver and~     the following second hit or multi-hit likely involves oxidative stress, lipid~     peroxidation, increased inflammatory responses, induced hepatic fibrosis and apoptosis. This~     emphasizes the multi-factorial pathogenesis of NAFLD and the necessity to treat NAFLD with~     diabetes-like and multimodal strategy. Several changes in dietary intake have occurred in~     the past few years, including increased energy intake (24%), and increases in added sugars,~     flour and cereal products, fruit, added fats and total fat intake. The increasing prevalence~     of NAFLD is probably directly affected by the contemporary epidemics of obesity, unhealthy~     dietary pattern, and sedentary lifestyle. Currently, there are two major categories of NAFLD~     therapy: lifestyle interventions and pharmaceutical therapies, lifestyle interventions in~     terms of diet and physical activity are regarded as safe and effective, while pharmaceutical~     interventions showed limited efficacy with unknown safety in the long term ,therefore, the~     first line of treatment is lifestyle modification. Although lifestyle intervention dose~     positively affects NAFLD, it has limitations. Patients adherence to dietary intervention is~     50%, while those who do adhere, find it difficult to maintain after 12 months. ).~     Mediterranean diet has been shown to be effective in reducing NAFLD, liver steatosis and~     improve insulin sensitivity. Acupuncture has been found as an effective treatment for~     improving quality of life in various medical conditions , including hepatitis . Acupuncture~     combined with life style intervention has been found effective in the treatment of obesity,~     metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers~     of inflammation. Acupuncture's effect on NAFLD has yet to be studied.~      We suggest that acupuncture combined with life style intervention can be an effective~     treatment for NAFLD.~   "
80304|NCT02006316|"~     The purpose of this study is to evaluate whether clinical varicoceles are associated with~     abnormal semen parameters and whether varicocelectomy could improve the semen parameter in~     patients unrelated with infertility.~   "
80340|NCT02005835|"~     The purpose of this study is to determine if enhanced support for women and their families~     within facilities and/or through community outreach will result in improved retention in the~     continuum of PMTCT care.~   "
80341|NCT02005822|"~     The objective of the trial is to investigate whether early treatment with oral~     valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural~     hearing loss can prevent progression of hearing loss.~   "
80305|NCT02006303|"~     The primary objective is to assess whether prostatic artery embolization has a similar~     efficacy and safety profile as GreenLight PVP in treating patients with urinary retention~     secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to~     either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.~      The primary endpoint of efficacy of the procedure is measured by the ability of the patient~     to void. The secondary endpoints recorded will include patients' satisfaction measured by~     International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual~     urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12~     months post treatment. Also, reduction in prostate volume is considered by MRI~     preoperatively, 3 months and 12 months.~   "
80306|NCT02006290|"~     The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease~     subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will~     also be evaluated.~   "
80307|NCT02006277|"~     This study is intended to evaluate the sensory attributes and estimate the relative~     bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses~     by swirl and spit (Cohort 1) or will receive five oral single 250-mg doses with a washout~     period of at least 14 days (Cohort 2).~   "
80308|NCT02006264|"~     This prospective, randomized, single-blinded, placebo controlled trial will examine the~     safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF)~     vaginal ring when used continuously for 14 consecutive days.~      The primary objective is to assess the safety of TDF vaginal rings when used continuously~     for 14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo~     vaginal ring.~   "
80309|NCT02006238|"~     This is a prospective, randomized, double-blind, crossover study. The purpose of this study~     is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in~     menopausal women. This study will require all prospective participants to fill out a week of~     Hot Flash Diary to determine eligibility before beginning the study. All prospective~     participants will be assessed for hot flash frequency, hot flash distress and hot flash~     severity according to their perception in the Hot Flash Diary during the experimental~     period.~   "
80310|NCT02006225|"~     Plerixafor has been intensively used in recent years for harvesting autologous stem cells~     from lymphoma and myeloma adult patients. Its use is indicated after failure to harvest with~     GCSF alone. Nevertheless, in the pediatric population its appliance is less well established~     and the indications are less well confirmed .Several disease states and diagnoses may prompt~     the anticipation of difficulties in harvesting stem cells using GCSF only. Such patients may~     benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with~     GCSF alone and only than go for plerixafor as second-line rescue procedure.~      In this study we propose to examine the applicability and feasibility of harvesting~     autologous stem cells by means of GCSF + plerixafor in first-line measure for pediatric~     patients with specific indications.~   "
80311|NCT02006212|"~     Neurologic complications after cardiac surgery range over a wide spectrum including~     postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular~     accidents (CVA). The incidence of these neurologic events varies depending on the type of~     surgery and the population studied. The incidence of PD and/or POCD is further influenced by~     the type of the neurologic tests used. Moreover, the timing of these tests seems to~     influence the results. Intraoperative cerebral monitoring is gaining importance in the~     anesthesia field. Recent findings have pointed out that cerebral hypoperfusion on one hand~     and deep levels of anesthesia on the other hand are major sources of adverse neurological~     outcomes, both of which can be detected with different non-invasive cerebral monitors.The~     present investigators are currently using the NeuroSENSE®, a processed electroencephalogram~     (pEEG) monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in~     every cardiac patient.~      This large, prospective, observational study will investigate whether the short- and~     mid-term neurologic outcome of adult patients undergoing cardiac surgery are in line with~     observations made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.~   "
80312|NCT02006199|"~     Hypothesis of this study is that mindfulness meditation would decrease the severity of~     obsessive-compulsive symptoms.~   "
80313|NCT02006186|"~     US children's active commuting to school (ACS; walking or cycling to school), previously~     common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity~     epidemic, which disproportionately affects low-income and ethnic minority children. Programs~     to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and~     related chronic disease risk are necessary. The Bicycle Train is an innovative program in~     which children cycle to and from school led by adults. Bicycle Trains provide another option~     for ACS, especially for children who live too far to walk to school. No randomized~     controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing~     the percent of children who cycle to school is sub-objective PA-14 of US Healthy People~     2020.~      The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among~     low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent~     accelerometer and GPS data and validate algorithms to identify and measure physical activity~     intensity and duration for children's cycling compared to heart rate monitors.~      Our Specific Aims will be to:~      SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot~     cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned~     full-scale cluster RCT (b) promoting their participation, and (c) identifying~     barriers/facilitators to their participation; and SA2) validate algorithms examining~     concurrent accelerometry and global positioning system (GPS) data to identify and measure~     children's physical activity intensity and duration while cycling compared to the criterion~     standards of heart rate monitoring and direct observation~      Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to~     test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be~     determined to be feasible if:~      FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle~     Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program~     on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer~     data have high agreement, i.e. >90% agreement, with heart rate data/direct observation in~     distinguishing children's cycling-related physical activity duration and intensity from~     other physical activities and riding in a motor vehicle~   "
80342|NCT02005809|"~     Gastroenterologists often follow up second look endoscopy after endoscopic submucosal~     dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure~     sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after~     endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the~     investigators try to identify the hypothesis prospectively in this study.~   "
80343|NCT02005796|"~     In this study, the postprandial glycemia and insulinemia caused by boiled potato with~     blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch,~     is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids~     and their metabolites is studied in plasma and urine.~   "
87752|NCT01908738|"~     The purpose of this study to determine effectiveness of paracervical block, lidocaine spray~     and only oral analgesic drugs for pain relief during endometrial biopsy.~   "
80314|NCT02006173|"~     This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed,~     single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan~     University Hospital Research Ethics Committee. The aim of this post-marketing study is to~     evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the~     effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential~     loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.~      The study was estimated to be held one and half year including a 0-2 weeks screening period,~     a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms~     will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF)~     severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets~     of randomized numbers are used, patient numbers and treatment numbers. Participants with odd~     patient numbers will be assigned to nasolabial group and those with even patient numbers~     will be assigned to nasolabial&cheekbone group. Participants receive experiment treatment~     (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with~     normal saline) in the other side of the face randomly depending on the treatment numbers.~     Both physicians and participants are only blind to the treatment assignment. 30 minutes~     after the injection, a post-photograph will be used to evaluate NLF severity scale scores~     and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the~     Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction~     will be collected from patients. The effectiveness analyses compare NLF severity scale~     scores and GAIS based on photograph records from physicians, as well as participant~     questionnaires for each group on every visit. The safety assessment evaluates any recorded~     adverse events following the device treatment.~   "
80315|NCT02006160|"~     Cognitive impairment is common in multiple sclerosis (MS) and has devastating impact on~     functional activities. There is great demand for medications that will enhance cognitive~     capacity in MS patients. To date, there is no evidence for improvement in cognition~     following treatment with aminopyridines, but the few studies on the topic included~     neuropsychological (NP) tests as secondary or tertiary outcomes, and were methodologically~     flawed. Dalfampridine may enhance cognition by direct pharmacological mechanisms, and should~     have effects on motor outcomes as in prior studies. By combining cognition and motor~     outcomes in the proposed study, the investigators will evaluate if the same patients with~     positive effects show beneficial responses on motor outcomes including physical activity and~     if such motor outcomes mediate and/or moderate cognitive improvements with dalfampridine~   "
80316|NCT02006147|"~     The purpose of this study is to determine whether ProDex provides an ideal, safe,~     long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of~     macular edema due to retinal vein occlusion (RVO).~   "
80317|NCT02006134|"~     Childhood chronic vasculitis describes a group of rare life-threatening diseases that have~     in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain.~     Most knowledge about them comes from adult patients. Severe disease requires aggressive~     life-saving treatments with steroids and some cancer drugs which can themselves cause~     damage, and increase risks of cancer and severe infections. Conversely, milder disease can~     be treated with less toxic drugs. Different classification and scoring tools are used to~     define the types and severity of vasculitis and to measure damage caused by disease or~     drugs. These in turn help direct how aggressively to treat a patient and to measure outcome.~     None of these tools however have been assessed in children and the best balance of disease~     and treatment risks against outcome for children is not known. Although causes of these~     diseases in children and adults are probably the same, the effects of the disease and the~     response (good and bad) to drugs will differ in growing children. Because specialists may~     see only one new child with vasculitis each year, obtaining enough information to learn~     about childhood vasculitis requires cooperation. We will use an international web-based~     registry to which doctors from 50 or more centers can contribute patient data. We will~     determine the features which help better classify and diagnose children compared to adults.~     Through the web we will collect and analyze information on patients similarly classified and~     scored so that most successful treatments can be identified. Children with vasculitis are~     less likely to have diseases associated with aging, alcohol and smoking etc., and therefore~     may be a better group in whom to study the underlying biology of vasculitis. We will use~     this opportunity and collect spit, blood and tissue from registry patients for laboratory~     study with an aim to find biomarkers to better classify, define and direct optimal treatment~     and outcomes.~   "
80318|NCT02006121|"~     The main purpose of this study is to investigate the efficacy of apomorphine subcutaneous~     infusion compared to placebo in advanced Parkinson's Disease patients.~      The secondary purpose of this study is to investigate the safety and tolerability of~     apomorphine subcutaneous therapy.~   "
80319|NCT02006108|"~     The goal of this study is to develop a non-invasive imaging test for in vivo detection of~     kidney transplant rejection. The hypotheses are that 1) Ferumoxytol-MRI can generate~     accurate estimates of tissue iron concentrations and tissue macrophages. 2) The signal given~     by a renal allograft on Ferumoxytol-MRI demonstrates significant differences between~     rejected and non-rejected transplants.~   "
80320|NCT02006095|"~     Carotid revascularization can significantly reduce the risk of stroke in patients with~     severe carotid stenosis; however, it has been associated with cognitive decline in 25% of~     the older adults who undergo the procedure. Characterizing risk factors for cognitive~     decline following carotid interventions and individualizing treatment strategy based on~     those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques~     that characterize white matter integrity and regional hypoperfusion have the potential to~     provide sensitive brain structure indicators that may be associated with memory decline~     following revascularization procedures. In this protocol, we hope to determine how cerebral~     blood flow and baseline white matter abnormality in the vulnerable region modify the~     frequency and cognitive effect of microembolization following carotid revascularization~     procedures.~   "
80321|NCT02006082|"~     The purpose of this study was to evaluate the effects of telemedicine video-consultation~     (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among~     patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to~     assess the impact of TVC on the length of recurrent hospital stays and time to re-admission~     within 12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction~     related to TVC.~   "
80322|NCT02006069|"~     The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing~     (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac~     Resynchronization Therapy (CRT) after 6 months.~   "
80344|NCT02005783|"~     To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with~     EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients.~     The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia~     induced by EC/TC regimen during chemotherapy.~   "
80345|NCT02005770|"~     Serious concern about the role of anesthesia in tumor recurrence has considerably risen over~     years, but the lack of surrogate markers for tumor spreading made trials addressing this~     issue difficult to realize. In breast cancer patients CTC positivity has been recently~     recognized as an independent prognostic factor. In this respect, we postulated that in a~     first step changes in the number of CTC after general anesthesia would help to determine the~     effect of anesthesia on this tumor marker.~   "
80346|NCT02005757|"~     The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and~     50mg tid in active rheumatoid arthritis patients unsuccessfully treated with~     disease-modifying antirheumatic drug.~   "
80323|NCT02006056|"~     The primary objective of the study is to examine the efficacy of Ondissolve for the~     prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in~     patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for~     painful bone metastases. The study population will be 30 patients seen in the RRRP at the~     Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic~     for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each~     day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8~     hours later the same day. Patients undergoing multiple fraction radiation therapy will take~     Ondissolve on weekends or holidays in between treatment. Secondary objectives include to~     evaluate key secondary endpoints related to RINV, and to investigate the ease and length of~     administration of protocol medicine. We hypothesize that Ondissolve will be effective in the~     prophylaxis of RINV, and the ease of use and administration will provide an appropriate~     delivery method for those unable to tolerate the oral form of ondansetron.~   "
80324|NCT02006043|"~     evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or~     recurrent NSCLC with EGFR wild type and without c-met expression~   "
80325|NCT02006030|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has~     been used to treat patients that have cancers that require arginine. In this study, the~     investigators will evaluate the response rate, as determined by the revised International~     Working Group recommendations.~   "
80326|NCT02006017|"~     The use of the best evidence available for decision-making is nowadays an undisputed goal in~     health care. However, this is not always achieved in the context of clinical practice. Two~     of the potential solutions to bridge the gap between evidence and the clinical practice are~     the evidence summaries and the evidence based recommendations. However, it is not clear,~     and frequently controversial, to what extent clinicians consider helpful recommendations~     accompanying evidence summaries. The investigators will explore this question by conducting~     a study where clinicians will be randomized to receive a clinical scenario accompanied by an~     evidence summary plus a recommendation and a second clinical scenario accompanied by only~     for an evidence summary (group A) or vice versa (Group B). The outcome will be clinicians'~     preferences.~   "
80327|NCT02006004|"~     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo~     or secondary AML in the PETHEMA Group institutions. This study is a non-interventional~     research regarding diagnosis and therapeutic approach~   "
80328|NCT02005991|"~     This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's~     Disease, distributes in the brain after one dose of PF-05212377 is administered orally to~     healthy volunteer subjects. The study will also evaluate the safety and tolerability of~     PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.~   "
80329|NCT02005978|"~     Acromegaly is caused by increased production of growth hormone (GH) from a usually benign~     pituitary tumor. The disease causes a number of complications including disturbances in~     glucose metabolism and about 25% of the patients develop diabetes. Most patients are cured~     upon surgery alone, but many require additional medical treatment, and in rare cases~     radiotherapy. A disadvantage of radiotherapy is a risk of radiation damage to nearby areas~     such as the hypothalamus. The true extent of irradiation induced hypothalamic dysfunction,~     however, remains uncertain.~      Data have shown significant improvement and often normalization of glucose metabolism upon~     surgical cure from acromegaly, whereas data suggest that such improvement is less likely in~     patients receiving additional radiotherapy.~      The hypothalamus is part of the so-called 'gut-brain axis', where gastrointestinal hormones~     through interaction with the hypothalamus plays a significant role in the regulation of~     appetite and glucose metabolism. Incretins are the most prominent gastrointestinal hormones~     involved, with the incretin-effect referring to food-induced insulin secretion, which in~     healthy subjects is responsible for up to 70% of the insulin response after oral glucose~     intake. The investigators hypothesize that radiation conditional influence of the~     hypothalamus may compromise the gut-brain activity and thereby affect the incretin-effect~     and gastrointestinal-mediated glucose disposal (GIGD; i.e. sum of all~     gastrointestinal-derived factors that contribute to glucose metabolism) in patients with~     acromegaly. The aim of the study is to investigate the long term effect of surgery with or~     without additional fractionated radiation therapy on glucose metabolism as assessed by~     incretin-effect and GIGD in acromegaly, in order to identify possible associations with~     treatment modality.~      The study population include 24 acromegalic patients who have previously received (N=12) or~     did not receive (N=12) pituitary irradiation as part of their treatment, and 12 matched~     healthy controls.~   "
80330|NCT02005965|"~     The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic~     Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary,~     multi-centre study. However, there were differences in patient outcome, dependent upon the~     position of the tumour in the rectum and its height above the anal verge. Whilst the outcome~     was excellent for patients who underwent an anterior resection, the outcome, based upon~     margin involvement and quality of the specimen, was poor for patients who underwent an~     abdomino-perineal excision for low rectal cancer.~      It is proposed that accurate MRI staging pre-operatively will allow the correct patients to~     receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the~     resection margins appear threatened so that the operation can be modified to take this into~     account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate~     of CRM positivity rate in low rectal cancer and to assess the difference in global quality~     of life at two years post surgery in patients according to plane of surgery with or without~     sphincter preservation.~   "
80331|NCT02005952|"~     Still not well resolved access, execution and interpretation of spirometry in primary care~     medicine. This seriously affects the quality of care of chronic respiratory diseases.~      OBJECTIVE: To compare the effectiveness of two methods for quality control in performing~     spirometry in primary care teams (EAP) participating in the Healthcare Process Chronic~     Obstructive Pulmonary Disease (COPD ) (multidisciplinary program between primary care~     medicine and hospital for improved care COPD).~      METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality~     control of spirometry in each EAP randomize into three branches:~        1. Supervision from the pulmonary function laboratory of the Hospital ; computer.~        2. Program incorporated into automated spirometer.~        3. Spirometric usual practice (control group without any support on the quality ).~          Spirometry EAP participants include year follow-up study . All sites use the same model~          spirometer and have received the same previous training . In a 2nd phase results~          implementing the most effective method shown in the 1st phase was studied.~      EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the~     quality spirometry.~      POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early~     detection (secondary prevention ) , the diagnosis of the severity and developmental control~     of COPD.~   "
80332|NCT02005939|"~     Biophenols can act as powerful antioxidants. Pomegranate (Punica granatum) provides a rich~     and varied source of biophenols with the most abundant being ellagitannins, tannins,~     anthocyanins, ellagic and gallic acids. Interest in antioxidant polyphenol-rich pomegranate~     products has increased in recent years with growing reports of potential health benefits.~     Pomegranate biophenols have been noted to lower systolic blood pressure, salivary stress~     hormones and increase insulin sensitivity in previous trials involving participants who have~     cardiovascular disease, but few studies have been conducted recruiting healthy volunteers,~     and those have made use of pomegranate juice rather than extract.~      The aim of this parallel study is to investigate the effect of pomegranate extract~     supplementation on blood pressure, lipid profiles, salivary stress hormones, insulin~     sensitivity, body composition and the perceived quality of life in healthy volunteers over 4~     weeks.~      It hypothesizes that consumption of biophenol-rich Pomegranate extract could increase~     insulin sensitivity and perceived quality of life while decreasing blood pressure, body~     measurements and stress hormones in healthy individuals.~   "
80333|NCT02005926|"~     -  This is a phase II, prospective, single-center, non-randomized, non-controlled study.~        -  Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast~          cancer. The potentially increasing false negative rate of SNB was concerned if the~          sonographic abnormal node was not excised. The aim of this study was to evaluate the~          accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.~   "
80334|NCT02005913|"~     The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early~     treatment at the local disease status of tumor. After curative resection of tumor, there are~     about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering~     metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is~     the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic~     patients, it is difficult to use CEA as biological marker to identify the population with~     high recurrent risk in patients with early-stage cancer because lower than half of patients~     with early-stage cancer do not have CEA elevation. For improving the survival of patients~     with early-stage CRC, we need effort to search more useful biological markers to predict the~     risk of tumor recurrence and to select out patients with high recurrent risk to receive~     preventive adjuvant therapy.~      Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis.~     Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the~     cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. In~     the past decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc),~     or flow cytometry have been developed but all of them have the shortcomings from low~     sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and~     cell culture. Recently, a biomimetic affinity based microfluidic platform has overcome~     abovementioned technical challenges. Importantly, by using only 2 ml of peripheral blood,~     Sinica's team has shown that the enumeration of CTCs increases with the CRC disease~     progression, where the mean CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III~     and IV, respectively. The results imply that monitoring CTC enumeration serially may serve~     as a prediction marker to identify the CRC patients with high probability of recurrence. The~     aims of this study are toestablishing CTC platform standard operation protocol (SOP) that~     leads to certification of ISO 13485 and to establish CTC criteria and evaluate its~     prediction power of early detection of colorectal cancer recurrence.~   "
80335|NCT02005900|"~     Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose~     homeostasis alterations, which are associated to the redistribution of body fat. Alterations~     in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic~     profile, which together with altered fibrinolysis markers and increased presence of~     proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes~     associated to the success of HAART can cause the development of accelerated atherosclerosis.~     Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability~     to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL~     particles thereby configuring less atherogenic plasma profile. Additionally, administration~     of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the~     risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a~     stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an~     increase in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by~     DHA, can decrease the elevated levels of TNF-alpha, which has been implicated in the~     pathogenesis of body fat redistribution in HIV infected patients undergoing HAART.~     Therefore, the hypothesis of this project is that DHA will be able to produce~     lipid-lowering, anti-inflammatory, hypotensive and profibrinolytic effects, which all~     together should improve atherogenic profile of patients with HIV-1 infection receiving~     HAART. In addition, their proprieties as PPAR agonist can improve the redistribution of body~     fat present in many of these patients. The study of the activity of DHA on dendritic cells~     and monocytes should indicate the absence of immunosuppressive effect of DHA in the context~     of HIV-1 infection.~      In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the~     therapeutic properties of which have been described in recent years and has shown~     cardio-vascular and metabolic beneficial effects, without recognized side effects. The~     highly purified DHA administration at high doses could be able to reverse, at least~     partially, lipid abnormalities associated with HAART and to exert a beneficial effect on fat~     redistribution in HIV-infected patients treated with HAART. To ensure non deleterious~     immunological treat in these sensitive poly-medicated patients, substantial changes in the~     functionality of dendritic cells and monocytic will be studied.~   "
80336|NCT02005887|"~     The purpose of the this study is to investigate the anti-tumor activity and tolerability of~     the study medications Degarelix and Triptorelin in premenopausal women receiving~     preoperative treatment with Letrozole.~   "
80337|NCT02005874|"~     The purpose of the study is to collect valuable data on the role of controlled humidity,~     temperature, airflow, and visual tasking in altering the tear film protein composition. The~     results from this preliminary study will help to explore the role of tear film markers in~     inflammatory and disease conditions. This can also be extended to understand the role of the~     tear film in protecting the ocular surface when individuals are exposed to low humidity~     environments which may incite discomfort symptoms.~   "
80338|NCT02005861|"~     BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying~     subchondral bone of the talar dome.~      The use of concentrated bone marrow derived cells has been gaining successful results with~     arthroscopic implantation, since it is possible to transplant not only mesenchymal stem~     cells but also accessory cells that support angiogenesis and vasculogenesis by producing~     several growth factors.~      OBJECTIVES Objective of this project is to identify the critical points of the regenerative~     treatment of osteochondral lesions of the ankle, in order to develop a standard and~     predictable procedure able to overcome the drawbacks of the previous techniques.~      METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral~     lesion of the talus. The surgical procedure will be executed as following: the day before~     the surgery the platelet gel will be produced. The day of the surgery bone marrow will be~     aspirate from the posterior iliac crest and concentrated directly in the operating room by~     centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.~      Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml~     of bone marrow concentrate and cut into an appropriate shape.~      After the scaffold implantation platelet gel will be sprayed on the top of implant, in order~     to provide extra growth factors and to improve the stability of the implant.~      All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and~     at maximum follow-up. Different score scales will be used to objectivate the clinical~     results (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI~     will be executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI~     called T2 mapping will be performed at 24 months.~      EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow~     derived cells (BMDCs) transplantation in a long term follow up study, with particular~     attention to identify the patient population that can gain the maximum benefit from this~     treatment, avoiding expensive and unnecessary procedures that too often are performed.~   "
80347|NCT02005744|"~     The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with~     impaired hepatic function compared with normal hepatic function.~   "
80350|NCT02005705|"~     Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow~     Blatchford score of zero will be randomly assigned to further care in the inpatient vs.~     outpatient setting. The hypothesis of this study is that patients who are managed as~     outpatients will require interventions at a rate not higher than those managed as inpatients~     and will have lower direct healthcare costs.~   "
80351|NCT02005692|"~     The study is designed to test the DynaSense system, which is a patient movement and~     orientation monitoring system. The study is intended to determine that:~        -  the DynaSense system identifies patients that are not turning adequately on their own~          and therefore require caregiver-assisted turns.~        -  the DynaSense system identifies patients that are turning adequately on their own and~          therefore do not require a caregiver-assisted turn.~        -  the DynaSense system helps ensure compliance with an institution's established patient~          turning protocol.~   "
80352|NCT02005679|"~     In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants,~     and according to very conservative estimates, about 44 000 deaf persons use the sign~     language. Additionally, the prevalence of dementia in France is close to 1% (850 000 dements~     for a total population of 65 millions). The prevalence of dementia in pre-lingual deaf~     adults has also been described and is between 1 and 1.4 /100 000 habitants.~      The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the~     cognitive evaluation for the detection of mental disorders including dementia, and a~     consensual French version exists prepared by GRECO (Group of Research and Cognitive~     Assessments). However, to date, there are no simple, rapid and validated screening tests to~     study cognitive disorders in deaf persons who use the sign language. The only tests~     available allow a late diagnosis avoiding an optimal treatment of the patients.~   "
80353|NCT02005666|"~     This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo~     Controlled, Three Arm Clinical Study.~      The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate~     1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of~     Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo~     respectively.~      Total study duration will be for a period of 78 days which includes treatment duration of 77~     days.~      850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria~     mentioned in the protocol.~   "
80354|NCT02005653|"~     Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as~     standard treatment for the clearance of W. bancrofti infection. It takes about one year for~     the individuals to completely clear the microfilaria from the blood. It takes another two to~     four years to clear the antigen. The aim of the present study is to shorten the time taken~     for clearing the Mf and antigen from the blood either by co-administration or sequential~     administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a~     randomized, double blind, controlled clinical trial to study the efficacy of these drug~     combinations in complete clearance the Mf and antigen from the blood in shorter span of 180~     days and 365 days respectively.~   "
80355|NCT02005640|"~     The objective of this study is to evaluate the effect of annular sizing strategy (MDCT~     versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of~     paravalvular regurgitation.~   "
80356|NCT02005627|"~     About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the~     nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the~     eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts~     for approximately 7 times more doctors' appointments than asthma. The standard treatment for~     hay fever consists of treating the symptoms with a nasal spray and an antihistamine.~     However, in a survey taken in a UK general practice less than 40% of patients with hay fever~     reported good symptom control with this standard treatment. For those patients with hay~     fever whose symptoms are not well controlled by treatment with antihistamines and nasal~     sprays, subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract~     for a period of 3-5 years) is an effective alternative, and is approved in the UK on a named~     patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed,~     including grass pollen allergen tablets. These have been shown to be highly effective in the~     treatment of hay fever, with the additional benefit of being convenient for patients, given~     that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium~     København (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the~     treatment of troublesome grass pollen induced hay fever. The aim of this research is to~     investigate the effects of the AIT treatment on the immune system over time - which changes~     are taking place and when in the course of treatment. This will provide insight into the~     complexities of the development of allergen-specific immune tolerance - how harmful allergic~     responses against innocuous substances such as grass pollen can be overridden.~   "
80357|NCT02005614|"~     The purpose of this study is to collect prospective data for use as a comparator for future~     subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife~     radiosurgery.~   "
80358|NCT02005601|"~     We are investigating the impact of duloxetine (Cymbalta), a serotonin and norepinephrine~     reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the~     investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain~     scores 2 weeks after TKA.~   "
80359|NCT02005588|"~     Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the~     investigators are going to compare the efficacy and tolerability of two preparations of oral~     iron in treatment of iron deficiency anemia with pregnancy.~   "
80360|NCT02005575|"~     The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the~     effect of the addition of dexamethasone to intraoperative intercostal nerve block~     bupivicaine solutions on the duration of pain relief and post operative pulmonary function.~   "
80361|NCT02005562|"~     This study will compare the incidence of acute clinical or subclinical rejection between~     immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug~     monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in~     kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and~     early discontinuation of steroids. Patients will be randomized to one of the two treatment~     arms. The anticipated time on study treatment is 52 weeks.~   "
80363|NCT02005536|"~     The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive~     Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.~      Primary Objective:~        -  To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3~          one month following the vaccination dose with SP059 as 2nd booster~      Secondary Objectives:~        -  To investigate seroprotection rates (percentage of subjects presenting poliovirus~          neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points,~          Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of~          individual titer ratio (GMTR).~        -  To investigate the safety after dosing of SP059 as 2nd booster.~   "
80364|NCT02004548|"~     Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of~     daily oral administration of metatinib tromethamine in subjects with solid tumors;~     Investigate the influence of food on pharmacokinetic parameters.~      Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral~     administration of metatinib tromethamine in subjects with solid tumors; To observe~     preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive~     biomarkers at MTD.~   "
80365|NCT02004535|"~     The objective of this study is to investigate benefits of binaural hearing for~     non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric~     candidates are patients with severe to profound hearing loss in one ear and better hearing~     in the other ear. (One ear is deaf and the other ear has better hearing and in most cases~     uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer~     ear provides a functional increase in word and sentence understanding in quiet or noise,~     perceived benefit, localization ability, and other measures of auditory performance relative~     to use of the better hearing ear alone.~   "
80366|NCT02004522|"~     A Phase 3 clinical trial to examine the efficacy of IPI-145 monotherapy versus ofatumumab~     monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or~     Small Lymphocytic Lymphoma (SLL).~   "
80367|NCT02004509|"~     Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and~     systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these~     patients. The detection of asymptomatic AF episodes is a challenge and the real rate of~     occurrence of these episodes remains unknown. The rate of stroke is high among patients who~     have received a pacemaker and this device can detect subclinical episodes of rapid atrial~     rate, which correlate with electrocardiographically documented AF. The net benefit of~     anticoagulant treatment is well established in patients with clinical AF but data about~     anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the~     impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable~     electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic~     embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods:~     This is a prospective, randomized, unicentric, parallel clinical study in patients with~     atrioventricular pacemaker, defibrillator or cardiac resynchronization therapy devices in~     sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial~     fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group~     - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a~     1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a~     period of 36 months. Group I patients will be submitted to device data collection every 2~     months, while the Group II patients will be managed conventionally. Patients from Group I~     with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with~     clinical AF of both arms. Device data from Group II patients will not be analyzed until they~     achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary~     endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial~     infarction, cardiovascular hospitalization and bleeding rates. Expected outcome: It is~     expected that anticoagulation therapy of subclinical AF directed by CIED intensive~     monitoring will reduce the incidence of stroke and systemic embolism comparing to patients~     with non-diagnosed subclinical AF.~   "
80368|NCT02004496|"~     Health care has an increasingly demand for mobile applications (App), but studies are rare,~     which explore the added value and benefits for patient and physician. Patients in different~     disease groups or physicians from different specialties are likely to have different~     demands. Research should focus on selected groups to better understand their individual~     demands. Our study intends to identify the added value of mobile symptom tracking in a~     selected subgroup of patients. We designed an App for breast cancer patients, who receive~     ambulant chemotherapy in a breast center. The patients track regularly their well-being and~     adverse events (AE) with the smartphone- or web-app and share it with the physician in the~     medical consultation. The data entry was designed to meet patient needs based on previous~     usability testing.~      The reporting of AE and well-being are standardized according to the definitions by CTCAE~     4.0 and ECOG-Index to ensure the reliability of patient self-reporting.~      The primary outcomes are the number of reported AE, the influence on their subjective~     well-being and the acceptance of context specific information. We will include 150~     participants in this study. The calculated power is 91% respectively 80% for a 10 %~     improvement of well-being and a 2.2 increase of detected AEs.~      The results will be compared to patients without App and to patients with App but without~     shared information.~        -  Trial with medical device~   "
80369|NCT02004483|"~     Investigators will analyzed systolic and diastolic function during and after ischemia~     induced by percutaneous coronary intervention.Also will be analyzed a local work index~     during acute ischemia induced by percutaneous coronary intervention.~   "
80370|NCT02004470|"~     The use of laparoscopy in gynecologic surgery has been well established to decrease~     morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional~     open abdominal surgery. However, the laparoscopic technique is associated with~     post-operative shoulder pain.~      We hypothesize that a combination of intraperitoneal saline lavage and active suction~     removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease~     incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon~     dioxide gas.~   "
80371|NCT02004457|"~     Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public~     health concern because reduced commitment to care puts PLWHA at risk for illness~     progression, death, and transmission of HIV to others. This project will develop a novel~     treatment, brief acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV~     status as a pathway to reducing engagement barriers. The clinical and public health impact~     of this project will be the development of a simple, low-cost, disseminable intervention~     that enhances longitudinal commitment to care so PLWHA can obtain effective medical~     treatments that will prolong survival and improve quality of life. We hypothesize that~     individuals randomized to brief ABBT will showed increased longitudinal attendance of~     primary care appointments.~   "
80381|NCT02004327|"~     1. Objective After single dose in healthy adults the capacity of the Group for DW1029M~          evaluate the pharmacokinetic characteristics.~        2. Indication Diabetic kidney disease~        3. Efficacy~             1. Primary~                  -  AUClast, AUCinf, AUClast/D, AUCinf/D~                  -  Cmax, Cmax/D~             2. Secondary~                  -  Tmax, t1/2, CL/F, Vz/F~        4. Safety~             1. Adverse Event Monitoring~             2. V/S, EKG, Laboratory Test, P/E~   "
80372|NCT02004444|"~     JC virus is a benign virus which infects approximately up to 90% of the normal adult~     population. However, it may be reactivated in people who have a decreased immune function as~     in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated~     with natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease~     called Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure.~      As of September 2013, 400 MS patients in the world, who have been treated with natalizumab,~     have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on~     the drug. Researchers do not know exactly in which cells of the body the virus lives but it~     has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of~     patients with immunosuppression.~      In this study, the investigators wish to determine precisely where the virus lives, and how~     the body prevents it from causing brain disease.~      Because of the association of PML with natalizumab, the investigators would like to see if~     there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients~     treated with natalizumab or those treated with different medications for MS, or those not~     treated at all. The investigators hope that this knowledge will allow us to find better ways~     of preventing the development of PML as well as treatments for patients with PML.~   "
80373|NCT02004431|"~     The experience of pain is common among hospital inpatients. Orthopaedic surgery often~     results in significant pain, which may last for some time. About one in eight people will~     experience long-term or chronic pain after surgery, which can impact on quality of life and~     mood. Some risk factors are known for chronic post surgical pain (CPSP) and these include~     patient factors, surgical factors and anaesthetic factors. We know that mood problems~     (anxiety and depression) increase the risk of CPSP. What is not known is how short term~     changes in mood are related to the experience of pain after surgery and how this impacts on~     CPSP. This study is designed to investigate the relationship between both short and~     long-term mood problems and short and long-term pain and quality of life after orthopaedic~     surgery. The study will provide valuable information to allow us to design a psychological~     intervention, which might reduce the risk of short-term post surgical pain and CPSP.~      This study also aims to measure a number of other variables, which may be related to CPSP~     including medication use, other medically unexplained symptoms and catastrophic thinking in~     response to pain.~      All patients having planned orthopaedic surgery will be asked to enter the trial. Those~     consenting to involvement will complete a questionnaire assessing the variables described~     above. They will be divided into two groups depending on whether they have significant pain~     on the day after their surgery. As the primary aim of the study, the rates of significant~     anxiety or depression will then be compared between these two groups.~      Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months~     after their surgery. Descriptive statistics will be produced for all the variables and use~     to model a future study, which would assess the effect of a psychological intervention on~     acute and chronic post surgical pain.~      Our hypothesis is that patients are more likely to experience acute anxiety and depression~     or display catastrophic thinking if they suffer significant post-surgical pain. The study is~     powered to reliably detect a three-fold difference in the prevalence of psychopathology~     between patients with and without acute pain on day 1 after elective orthopaedic surgery.~   "
80374|NCT02004418|"~     Patients with localized prostate cancer are routinely treated with radiation therapy to the~     entire prostate gland. The investigators can identify where the cancer is concentrated in~     the prostate gland using a newer specialized imaging technique called 11C Choline PET~     (stands for choline positron emission tomography). This is different from the older type of~     PET scan that has been used in the past (called FDG PET) which has not been as accurate as~     the new PET scan for identifying where the cancer is in the prostate gland. It has also been~     shown that delivering higher doses of radiation to prostate cancer cells in the prostate~     have resulted in better cure rates in patients with prostate cancer. Therefore for goal~     number one the investigators want to give higher radiation dose to the prostate cancer~     cells. But the challenge has been that delivering higher doses of radiation to the prostate~     gland may also increase the chance of complications from the higher doses of radiation to~     the rectum, bladder and surrounding area. Therefore for goal number two the investigators~     want to minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla~     Magnetic Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to~     identify the urethra in the prostate so that the investigators can minimize the radiation~     dose to the urethra. The investigators believe the 3T MRI scan is able to point to the areas~     of cancer that may be able to predict how well the treatments may work, as well as which~     areas of the tumor appear to be responding to failing.~      In this study, the investigators will keep the dose of radiation to the rectum and bladder~     as low as possible while increasing radiation dose to parts of the prostate with more cancer~     cells. The investigators will compare the cure rates in this study with the cure rates of~     other patients receiving the standard treatment in which the same dose of radiation is~     delivered throughout the prostate gland. The investigators will also compare the rates of~     complications in this study with the rates of complications in patients receiving the~     standard treatment in which the same dose of radiation is delivered throughout the prostate~     gland.~   "
80375|NCT02004405|"~     Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many~     symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits~     potentially mediated through changes in autonomic modulation. Strengthening is one of the~     less studied exercises in FM, and the acute and chronic effects of strengthening on the~     autonomic system remain unknown. The objective of this study is to assess the effects of~     strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of~     life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly~     selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity~     of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12~     different exercises. The primary outcomes will be pain measured using the Visual Analog~     Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess:~     fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench),~     handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ),~     the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36).~     Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be~     the primary measure used to determine sample size. Statistical significance will be set at~     5% and power of 80%. These led to at least 58 participants to be randomized. The main~     hypothesis is that strengthening exercise is a better treatment than flexibility exercise to~     improve pain, HRV and quality of life. In all measures tested we will consider the null~     hypothesis (H0) as being the point of equality between groups tested and H1 the point of~     difference. Bilateral tests were carried out adopting a 5% level of significance. The~     normality of the results will be tested using the Shapiro-Wilk test. Student's t-test for~     paired samples will be used to perform intra-group comparisons at different times, when the~     data were normally distributed, and the nonparametric equivalent of Student's t-test~     (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the~     data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by~     post-hoc Bonferroni's test.~   "
80376|NCT02004392|"~     This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled~     studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study~     EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive~     EVP-6124 for an additional 26 weeks.~   "
80377|NCT02004379|"~     Know through routine clinical practice the effectiveness and safety of current treatment of~     hepatitis C virus, genotype 1, for patients who have never been treated and for patients who~     have been previously treated~   "
80378|NCT02004366|"~     A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure~     will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication~     or low dose insulin prior to their admission.~      This study is a prospective, randomized, open label trial to compare the safety and efficacy~     of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin~     regimen of glargine once daily plus rapid-acting insulin before meals. Both of these~     treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart,~     lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.~      The patients will be monitored for their blood sugars while the hospital.~      If patients are agreeable to participate in the discharge part of the study, the~     investigators will randomized them to a treatment group based on their admission HbA1c. The~     investigators will follow these patients for 3 months with phone calls and clinic visits,~     and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our~     discharge treatment algorithm in controlling blood sugars as out patients.~   "
80382|NCT02004314|"~     This study will evaluate the effect of chloroquine in individuals infected with HIV.~     Researchers will aim to determine if chloroquine treatment in participants whose viral loads~     are suppressed on combination antiretroviral therapy (ART), results in improved immune~     activation and CD4 cell recovery.~      The study will recruit 20 individuals and will last approximately 44 weeks. Eligible~     participants will receive an oral dose of chloroquine (250 mg) once daily from week 8~     through week 32. All participants will be asked to have rectal biopsy samples (week 0 and~     week 32) to study T cell immune activation in the mucosa rectal site.~   "
80383|NCT02004301|"~     This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male~     volunteers. This study is designed to correlate the gastrointestinal transit behaviour of~     delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption~     profiles.~      We will be looking at:~        1. The behaviour of the tablets (when, where and how quickly they break up)~        2. The gastric emptying time of the tablets (when they leave the stomach)~        3. The gastrointestinal transit of the tablets (how long they take to travel through the~          gut)~        4. Blood levels of the drug (diclofenac)~   "
80384|NCT02004288|"~     The aim of this study is to investigate whether Lactobacillus reuteri could have a~     beneficial role in treatment of children and adolescents with Anorexia nervosa who develop~     motility disorder due to the malnutrition regarding the normalization of the motility, as~     well as the possible role of probiotics on nutritional recovery, especially on bone health.~   "
80385|NCT02004275|"~     This randomized phase I/II trial studies the side effects and best dose of pomalidomide and~     ixazomib when given together with dexamethasone and to see how well pomalidomide and~     dexamethasone with or without ixazomib works in treating patients with refractory multiple~     myeloma. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the~     immune system in different ways and stop tumor cells from growing. Ixazomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether pomalidomide and dexamethasone are more effective with or without ixazomib in~     treating multiple myeloma.~   "
80386|NCT02005523|"~     The purpose of this study is to see if use of RNS60 during hip labral repair surgery~     decreases pain and improves functional capacity post-operation.~   "
80387|NCT02005510|"~     The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV)~     screening kits is effective in increasing uptake of cervical cancer screening and early~     detection and treatment of cervical neoplasia in underscreened women.~   "
80388|NCT02005497|"~     The proposed project will answer key questions about implementing evidence-based health~     promotion interventions at small and low-wage worksites. Small, low-wage worksites will be~     randomized to receive HealthLinks (a free American Cancer Society program to disseminate~     evidence-based interventions), HealthLinks+ (which will include creating worksite wellness~     committees as part of the program), or to serve in a delayed control group. This approach~     will identify successful strategies for implementing evidence-based interventions at~     low-wage worksites to improve workers' cancer screening, healthy eating, physical activity,~     and tobacco cessation.~   "
80389|NCT02005484|"~     This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or~     advanced gastric cancer with disease progression during platinum-based or~     5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until~     disease progression.~   "
80390|NCT02005471|"~     This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab~     (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with~     relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the~     two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose~     400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each~     28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).~      Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab~     infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70~     mg/m2) on Days 1 and 2 of each 28-day cycle.~      Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or~     2 years since treatment start, whichever comes first. Anticipated time on study is up to 5~     years.~   "
80391|NCT02005458|"~     This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy~     and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia~   "
80392|NCT02005445|"~     This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for~     obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including~     impact on exercise capacity, disability, and quality of life.~   "
80393|NCT02005432|"~     Objectives:~      Primary objective:~      To evaluate the effects on retinal morphophysiology of full scatter single target panretinal~     photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both~     combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab~     (IVR) alone in patients with proliferative diabetic retinopathy (PDR).~      Primary outcome:~      The primary endpoint for this study is the mean change in the total area of active retinal~     neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to~     week 48.~      Secondary objectives:~        -  To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in~          central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and~          oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on~          the peripheral visual field by static perimetry (30:2 strategy), from baseline to week~          48.~        -  To assess the incidence of adverse events during the study.~      Strategic goal:~      In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to~     determine what would be the best association of PRP + anti-VEGF for proliferative diabetic~     retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better~     regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG~     response and visual field).~   "
80409|NCT02005224|"~     Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on~     bout of exercise in combination with either a normal diet or a LCHF diet, in relation to~     glucose metabolism, insulin sensitivity, lipid profile and body composition.~   "
80394|NCT02005419|"~     Pancreatic cancer represents the most lethal of the common malignancies with a 5-year~     survival rate of less than 5%. For patients who are eligible for potentially curative~     resection, despite mortality and morbidity rates after surgery have improved, the recurrence~     rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant~     chemotherapy enhances 5-year survival to ~25% for patients who have undergone surgery to~     remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is~     the first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin~     might inhibit tumor growth by blocking some enzymes needed for cell growth. Some~     retrospective studies have revealed that diabetic patients taking metformin were less likely~     to develop pancreatic cancer. Additionally, pancreatic cancer patients treated with~     metformin showed a better survival than those without metformin. In this study, the~     researchers intend to investigate the activity and safety of the combination of gemcitabine~     and metformin in treating patients with pancreatic cancer that have removed by surgery.~   "
80395|NCT02005406|"~     Testing the efficacy and safety of the WEI Nasal Jet.~   "
80396|NCT02005393|"~     The study is intended to test the image quality of the FICE system to the predicate device,~     Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.~   "
80397|NCT02005380|"~     The focus of this work is to explore the use of modern mobile technology to enable people~     with Alzheimer's disease to improve their abilities to perform activities of daily living~     and hence to promote independence and participation in social activities. This work also~     aims at reducing the burden on caregivers by increasing the AD patients' sense of competence~     and ability to handle behavior problems.~   "
80398|NCT02005367|"~     A person-centered substance use treatment component, the Natural Recovery Program, was~     developed in a residential substance use treatment setting. The Natural Recovery Program is~     comprised of small group therapy combined with pursuit of hobbies. The study examined~     treatment retention, treatment completion and satisfaction of participants of Natural~     Recovery compared to those who participated in core residential treatment activities alone.~   "
80399|NCT02005354|"~     The approach of this study will be to answer the question does high-frequency stimulation~     Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during~     the bone marrow sampling procedure in addition to the standard analgesia given (ie. local~     anaesthetic with or without inhaled nitrous oxide).~      Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow~     sampling procedure in addition to the standard analgesia given~   "
80400|NCT02005341|"~     The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler~   "
80401|NCT02005328|"~     The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability~     of three new oral sprays with a reference oral spray in the relief of drug-induced~     xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of~     salivation (hyposialia) induced by chronic drug intake.~   "
80402|NCT02005315|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with nab-paclitaxel and gemcitabine.~   "
80403|NCT02005302|"~     Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness~     of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet~     treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.~   "
80404|NCT02005289|"~     This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal~     antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or~     previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or~     prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody~     MOR00208, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Biological therapies, such as lenalidomide, may stimulate the immune~     system in different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal~     antibody MOR00208 and lenalidomide may kill more cancer cells.~   "
80405|NCT02005276|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. We will assess outcomes each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
80406|NCT02005263|"~     Disease of the fallopian tubes is one of the most common reasons for infertility. The most~     common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses~     concurrent uterine disease. We propose using a less painful technique (through modified~     office hysteroscopy) for tubal assessment that can be performed in the office rather than~     hospital radiology and that uses gold standard technology for identifying coexisting uterine~     conditions.~   "
80407|NCT02005250|"~     The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and~     one year after treatment for a thyroid functional disorder~   "
80408|NCT02005237|"~     Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date,~     there are no available treatments to improve cognition in this patient population. Some~     evidence from animal studies and small clinical trials suggest that aerobic exercise might~     beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is~     to explore if an aerobic exercise training program can enhance cognition in MS. In addition,~     we will employ neuroimaging markers to determine if exercise alters measures of brain~     structure and function.~      Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry,~     2-3 session per week) or a waitlist control group. The primary endpoint of the study is a~     test of verbal learning and memory. Secondary endpoints include neuroimaging markers of~     functional and structural connectivity in the brain. We hypothesize that exercise will~     improve verbal learning and memory and beneficially affect measures of brain connectivity.~   "
80413|NCT02005172|"~     In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14~     day event monitor with the use of both devices simultaneously. We will also examine by means~     of a questionnaire the compliance, ease of use and patient satisfaction for each device.~      Hypothesis:~        1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to~          diagnosis of the arrhythmia responsible for a patient's symptoms.~        2. The AliveCor monitor will have better compliance and acceptability compared to the 14~          day event monitor, and thus there will be a greater number of days with recordings from~          the AliveCor monitor.~   "
80414|NCT02005159|"~     Provide scientific and validated data to help International Authorities to set susceptible~     to antibiotics cut-off points in bacteremia by Enterobacteriaceae~   "
80415|NCT02005146|"~     Define the patients who lost HBsAg, studying the loss predictive factors and if there was~     suspension of treatment, study the evolution after that~   "
80416|NCT02005133|"~     To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior~     treated wet AMD patients managed in 'real wold' clinic settings.~   "
80417|NCT02005120|"~     Malignant pleural effusion (MPE) is a common complication of advanced non-small cell lung~     cancer (NSCLC). Bevacizumab, a humanized monoclonal antibody against vascular endothelial~     growth factor (VEGF), has been shown to be efficient in suppressing the accumulation of~     pleural fluid. The other widely used treatment for MPE is recombinant human endostatin.~   "
80418|NCT02005107|"~     This study is being conducted to evaluate how the body absorbs and processes the immediate~     release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are~     1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate.~     Non-surgical controls will also be enrolled based on a matching criteria to post gastric~     bypass subjects. Participants will be asked to complete two 12-hour study days approximately~     11 days apart. This study will enroll up to 30 participants.~   "
80419|NCT02005094|"~     1. To investigate the inflammasome response of inflammatory and resting macrophage derived~          from healthy human participants by stimulation using MAC or MAB bacilli.~        2. To compare the difference of inflammasome response of inflammatory macrophage by~          MAC/MAB bacilli stimulation between MAC/MAB-LD patients and the colonizers.~        3. To study the diagnostic aid from immunological markers in inflammasome response in~          inflammatory macrophage stimulated by MAC/MAB.~   "
80420|NCT02005081|"~     The purpose of this single-center, prospective, randomized study is to determine the fusion~     rates along with the clinical outcomes of commercially available bone graft substitutes~     Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized~     bone matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion~     in patients experiencing cervical spondylotic myelopathy (CSM).~   "
80421|NCT02005068|"~     This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint~     infections.~   "
80422|NCT02005055|"~     This prospective study evaluates the outcome of surgical excision with adjuvant~     high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are~     recurrence rate, scar quality and physical complaints.~   "
80423|NCT02005042|"~     Lack of physical activity is associated with negative health outcomes, including obesity,~     diabetes, and cardiovascular disease. There are calls from NIH and medical organizations to~     integrate the use mobile devices, such as smartphones, to provide e-health interventions~     to patients in their daily life. Referred to as Ecological Momentary Interventions [EMI],~     these innovative mobile methods provide an opportunity for researchers and clinicians to~     offer tailored intervention material to people at specific times and in specific settings~     when they may be most in need of such support. To our knowledge no study has used objective~     ambulatory assessment data to deliver EMI. This preliminary work is to demonstrate the~     feasibility, and test preliminary efficacy, of using a Bluetooth accelerometer to provide~     real-time feedback on a smartphone to increase objectively measured steps (i.e., increase~     activity). A within-person design will be used, including assessment, intervention, and~     follow-up phases. During the assessment phase objective physical activity (using~     accelerometers) will be collected. In the intervention phase participants will also receive~     real-time feedback throughout the day regarding their total steps and personalized step~     goals. Objectively measured steps and disease status measures will be used to evaluate~     efficacy.~   "
80424|NCT02005029|"~     Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa~     (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse.~     Gastroparesis effects how the levodopa is absorbed and used by the body. This study will~     explore the possibility of using Erythromycin, a drug commonly used (off label) for~     gastroparesis, along with levodopa to determine if there is improved levodopa absorption and~     motor function.~   "
80425|NCT02005016|"~     This study examines aphasia treatment response among Veterans and non-Veterans living with~     aphasia. It seeks to identify cognitive and neural factors which are predictive of positive~     response to treatment targeting naming impairments in aphasia. It also examines the~     dose-response relationship for naming treatment. More broadly, it seeks to determine who~     aphasia therapy works best for, and how much aphasia therapy is sufficient to achieve~     positive treatment response.~   "
80426|NCT02005003|"~     To examine the cognitive and metabolic effects of a probiotic supplement that is readily and~     already available for purchase in public drug stores. This study is a double-blinded~     randomized cross-over placebo-controlled intervention study. Participants will be randomized~     to receive either the probiotic supplement or the placebo during the first intervention~     period which will last 2 weeks. This will be followed by a washout period, after which they~     will proceed to the second intervention period, also lasting 2 weeks and also followed by a~     washout period.~   "
80445|NCT02004756|"~     Primary Objective: To determine if impairments in cardiac and musculoskeletal function and~     metabolism exist in Fontan children.~      Secondary Objectives:~        1. To determine if impairments do exist, are they related to exercise capacity.~        2. To determine if a 12-week exercise training intervention improves cardiac and/or~          musculoskeletal metabolism.~      Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal~     function are evident, influence exercise capacity, and can be improved with exercise~     training.~   "
80427|NCT02004990|"~     The overall goal of this study is to improve the standard of care in treating young children~     who often suffer from chronic caries (dental decay). Current standard of care for children~     under 12 years old includes a dental cleaning and fluoride treatment. Often this dental~     cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small~     rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental~     prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces.~     After this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child~     Oral Health Resource Center at Georgetown University has published (Bertness J, Holt K) an~     extensive publication proving that 5% sodium fluoride varnish has become the 'standard of~     care' for fluoride treatment in children. This study includes this fluoride standard of~     care.~      Prior to the administration of this standard of care fluoride treatment, a separate step of~     cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing~     procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.~      The primary aims of this study are:~        1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI)~          cleansing prior to fluoride varnish (FV) application.~        2. to measure the short term changes in the oral microbial ecology of dental plaque after~          10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.~   "
80428|NCT02004977|"~     The goals of this intervention study are to implement best practice strategies to expand and~     promote the school breakfast program and test the impact upon student participation rates~     among a) all 10th and 11th grade students and among a randomly selected cohort of 800~     students b) total diet and body mass index and percent body fat inin 16 rural Minnesota~     school districts.~      School-wide Primary Aim: Improve participation in the school breakfast program among high~     school students. Hypothesis: School-wide school breakfast program participation will be~     higher in the intervention versus comparison group.~   "
80429|NCT02004964|"~     Protocol to screen potential subjects for islet transplantation~   "
80430|NCT02004951|"~     Over the past years, endovascular interventions have become an important part of treatment~     in patients with peripheral arterial disease.1 Indication for endovascular repair of~     femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1~     Enlargement of endovascular therapy indication was based on patient choice for a less~     invasive technique and evidence based medicine. Consequently, TASC classification of lesions~     has been modified to reflect increased evidence for endovascular treatment of more extensive~     femoropopliteal lesions, and indication for endovascular repair has been enlarged to more~     severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions~     which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the~     interventionalists have at their disposal a huge tool box. Evaluation of these tools is~     crucial to determine the right treatment strategy to avoid further reinterventions and~     overcosts.~      The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent~     (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of~     above-the-knee intermediate length femoropopliteal lesions.~      From hospitals in Europe (France, Switzerland) we will randomly assign patients with~     symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent~     or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).~   "
80431|NCT02004938|"~     Project Aims: The purpose of this study is to determine the size of the right internal~     jugular vein (RIJV) in children with normal respiratory physiology during the respiratory~     cycle and evaluate the reliability of those measurements.~      Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be~     reliably measured in the respiratory cycle.~      Intervention: We will ensure that the patient is not having any respiratory symptoms or~     signs of dehydration. A clinical asthma score will be assigned using the Modified Woods~     pulmonary index scoring system. The Gorelick Dehydration Scale with also be calculated.~      Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement~     will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees~     with the subject's head in the neutral position and then turned 45 degrees leftward.~     Measurements of the internal jugular vein at maximal inhalation and exhalation will be~     recorded. Reliability calculations will be assessed.~   "
80432|NCT02004925|"~     Pneumoperitoneum could be due to life threatening conditions and its quickly diagnosis is~     important in the emergency department (ED). Signs and symptoms are non-specific and~     radiography has low accuracy in the acute setting. Computed tomography (CT) is considered~     the gold standard, however it is not a cost-effective option in the vast population of~     patients with abdominal pain. Ultrasonography is able to detect as little as 2 ml of free~     air, however diagnostic accuracy of ultrasonography remains unclear. This study evaluates~     the accuracy of ultrasonography for the diagnosis of pneumoperitoneum, the most accurate~     abdominal scan and the most accurate echographic sign for the detection of free air.~      Methods Consecutive patients presenting to ED for acute abdominal pain and with a diagnosis~     of pneumoperitoneum at CT or at surgery (study group) and a similar number of patients~     without a diagnosis of pneumoperitoneum (control group) undergo abdominal ultrasonography in~     a standardized protocol that include 10 scans for each patient registered on a video of 5~     seconds. The videos are randomly reviewed by 4 sonographers and by 2 physicians with no~     experience in ultrasonography blind to final diagnosis and to all clinical data with the aim~     of detecting for each scan pneumoperitoneum. Accuracy of ultrasonography for the diagnosis~     of pneumoperitoneum will be calculated considering CT or surgery as gold standard.~     Furthermore intra and interobserver agreement and the accuracy of each ultrasonographic sign~     and scan will be calculated.~   "
80433|NCT02004912|"~     Our hypothesis is that an on-site mentoring program for staff at primary health care centers~     in northern Karnataka, will improve the quality of maternal, neonatal and child health care,~     and improve clinical outcomes.~   "
80458|NCT02004587|"~     The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an~     additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy~     White subjects will be investigated.~   "
80475|NCT02004067|"~     In the present study the investigators aim to determine the efficacy of an immunomodulating~     topical medication, compared with a topical lubricant, on the treatment of dry eye disease~     (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative~     DED.~   "
80434|NCT02004899|"~     Epidural analgesia is the most effective form of labor pain relief. Low doses of local~     anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as~     epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids~     for labor have been shown to decrease motor block (leg weakness or temporary paralysis),~     without affecting labor pain relief. However, onset of pain relief can be delayed with these~     low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose~     of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural~     pain relief.~      There is some evidence that the addition of more fentanyl to the epidural bolus dose of~     bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both~     medications are safe for you and your baby.~      This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50~     mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.~      The study hypothesis is that the onset of epidural labor analgesia will be shortest with the~     larger fentanyl epidural bolus.~   "
80435|NCT02004886|"~     This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in~     participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will~     reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.~   "
80436|NCT02004873|"~     The purpose of this clinical study is to evaluate the safety and efficacy of the Micra~     Transcatheter Pacing System and to assess long term performance.~   "
80437|NCT02004860|"~     Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by~     relapses, affecting mainly the face and scalp. It would be important to have a maintenance~     treatment for severe forms of seborrheic dermatitis witch is both effective and relatively~     well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack~     treatment and reduce the use of topical steroids.~   "
80438|NCT02004847|"~     The purpose of this study is to determine the efficacy and safety of a blue light device for~     treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an~     untreated control plaque. Additionally, two intensities of blue light are compared.~   "
80439|NCT02004834|"~     The purpose and the goal of this paper is to show whether the application of a combination~     of two local anesthetics, as opposed to the application of one local anesthetic at~     paravertebral block changes the hemodynamic variable. It is therefore a prospective~     randomized double- blind study, where we do a clinical trial in patients ASA(American~     Society of Anesthesiologists) 1 and 2 statuses between 18 and 80 years of age, using the~     ultrasound in plane technology.Upon arrival of patients in the unit for preparation~     procedures for anesthesia we set the ECG(electrocardiograph), noninvasive blood pressure,~     oxygen saturation, and arterial cannula in the radial artery After sterile washing of the~     dorsal surface, paravertebral space was identified with ultrasound using 8 Hz(hertz) linear~     transducer probe then needle position was confirmed with neurostimulation at the level of~     2.0 - 5.0 mA(milliampere). When muscle contraction persisted at 0.4mA(milliampere), the~     anesthetic was applied in levels of Th 2, Th3, and Th 4 (7,0 milliliters per level). We~     applied the 0.5 % levobupivacaine and 2 % lidocaine, 7,0 milliliters of mixture per level in~     one group, while only 0.5 % levobupivacaine also 7,0 milliliters. by level in the second~     one. After that, the invasive hemodynamic monitoring was placed on patients and the~     induction with 1 % propofol 2-2.5 mg/kg.and Vecuronium 0,08 mg/kg. was performed with the~     application of supraglottic airway gel of appropriate size. The maintenance of anesthesia~     and sedation will be conducted with Propofol 1 % continuously ( 25-150 mcg / kg / min.)The~     measurements will be taken every 5 minutes during the first hour of the application of~     paravertebral block, then every 15 minutes during the second hour and if the operation takes~     more than two hours, the measurements are performed every 30 minutes. Postoperatively,~     invasive hemodynamic monitoring will be removed in post-anesthesia recovery room together~     with the arterial cannula and the patient will be sent to the hospital ward with~     non-invasive hemodynamic monitoring (blood pressure, pulse, saturation) until the~     termination of the blocks.Statistical methods, By comparing two target groups, we analysed~     the strength of the test with following assumptions: X2 difference test, the expected~     difference in variances in stroke volume between groups of 60%, α significance level of~     0.05, and the minimum statistical test strength of 85%. The required total sample should~     include at least 80 patients, that is, 40 per group.Data will be presented in tables and~     graphs. Descriptive statistics of examined variables with appropriate measures of central~     tendency will be made. Smirnov -Kolmogorov test will assess the normality of data~     distribution. According to the received results, the appropriate parametric and / or~     nonparametric tests will be used. Comparisons of quantitative values between the two groups~     will be analyzed using the independent t-test or Mann-Whitney U test. Dependent values~     within each group will be analyzed using analysis of variance for repeated measures or~     Friedman test. Differences in categorical values will be analyzed by X2 test. The~     appropriate regression model will be made in order to predict the variability of stroke~     volume in which the dependent variable will be a variation of the stroke volume, while~     relevant clinical values will be taken as predictor variables. All P values smaller than~     0.05 will be considered significant.~      This research is to present the main results - the existence of the significant change in~     Stroke Volume Variation (SVV) between groups using invasive hemodynamic monitoring, the~     changes of Stroke Volume Variation(SVV) depending on the time from the application within~     groups, differences in volume compensation of crystalloids and colloids and the need for the~     application of vasoactive drugs. Furthermore, as a secondary results we will present the~     time to maximal block development, the duration of post operative analgesia, patient~     satisfaction and time needed for the full recovery from the block.~   "
80440|NCT02004821|"~     The purpose of this study is to evaluate the molecular differences between a group of~     Constitutionally Thin (CT) subjects and a group of controls.~   "
80441|NCT02004808|"~     NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea~     treatment.The study hypothesis is that NETs formation by neutrophils has a role in the~     induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte~     count in children with sickle cell anemia is a bad prognostic sign due to NETs formation~     supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might~     prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil~     count and inhibiting NETs formation.~   "
80442|NCT02004795|"~     This is a boron neutron capture therapy (BNCT) combined with image-guided intensity~     modulation radiotherapy (IG-IMRT) for patients with previously irradiated and locally~     recurrent head and neck cancer. The primary end points are treatment toxicities and response~     rate. The secondary endpoints are time to tumor progression, progression-free survival,~     overall survival and change quality of life.~      Head and neck(H & N) carcinomas that recur locally after conventional irradiation pose a~     therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture~     reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal~     energy to yield high energy alpha particles and recoiling lithium nuclei. The effect of~     alpha and 7Li is primarily limited to boron-containing cells. Preferential uptake of boron~     into cancerous tissue is achieved using boron carriers such as a derivative of~     phenylalanine, boronophenylalanine (BPA). After administration of BPA by intravenous~     infusion, the tumor site is irradiated with neutrons, the source of which is currently a~     nuclear reactor, like the Tsing Hua Open-Pool Reactor (THOR), a 2MW research reactor at~     National Tsing Hua University (NTHU) in Taiwan. Since it is a target radiotherapy, low~     complication rate after BNCT can be obtained. However, further local recurrence after BNCT~     for recurrent H & N cancer was reported in several publications.~      Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional~     imaging, during a course of radiation treatment, used to direct radiation therapy utilizing~     the imaging coordinates of the approved radiation treatment plan. IGRT such as Cone-Beam CT~     (CBCT) using an On-Board Imager (OBI) enhance delivery and further improve outcomes as the~     treatments create a higher level of precision. By combining BNCT and IG-IMRT, we expect to~     procure high control rate of recurrent H & N cancer with acceptable toxicity. This study~     will be the first BNCT plus IG-IMRT trial to treat head and neck cancer in Taiwan.~   "
80443|NCT02004782|"~     Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer.~     Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts~     mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic~     mucosal resection (EMR) during gastroscopy. If patients can be effectively treated by EMR~     while they have premalignant or early malignant disease, it is a curative procedure.~      Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue~     development in the oesophagus, leading to stricture formation and difficulty swallowing~     (dysphagia). If a safe and effective method could be found to reduce this risk, the~     treatment options for early oesophageal cancer would be greatly improved. CBE is performed~     as a two stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised,~     doubleblind study, eligible and enrolled patients are randomised after the 1st stage CBE to~     receive either prednisolone tablets or placebo. Inclusion criteria are patients with short~     segment (<3cm circumferential disease) Barretts oesophagus with high grade dysplasia or~     early cancer. The treatment period is for 6 weeks after both CBE sessions. Prednisolone is~     given in a reducing dose over the 6 weeks, starting at 40mg daily.~      The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be~     performed as required for dysphagia secondary to symptomatic oesophageal stricture formation~     persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance~     with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to~     assess for complete removal of Barretts mucosa.~      Following two stage CBE, stricture rates without preemptive therapy in noncircumferential,~     circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70%~     respectively. The investigators predict a 50% reduction in stricture rate with oral steroid~     therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of~     significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop~     out rate, a total of 126 patients are required. The study will be performed at five~     Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.~   "
80444|NCT02004769|"~     Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic~     gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease~     are to be recruited in the study. In the current study, the efficacy and safety of~     Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients~     with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate~     precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60~     patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will~     be enrolled.~   "
80471|NCT02004119|"~     This study is an randomized double-blind placebo-controlled study to evaluate the efficacy~     and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis.~     Pharmacokinetics of KHK4577 will also be assessed.~   "
80476|NCT02004054|"~     The investigators' hypothesis is that measuring the PCTdynamics would be an easy and~     reliable symptom to evaluate in pathologies affecting the optic nerve~   "
80446|NCT02004743|"~     Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients~     annually. A traumatic experience can lead to post-traumatic stress disorder, which increases~     hospital stays, emergency visits and disability. Despite developing leadership to manage a~     Code Orange mass trauma, Sunnybrook lacks guidelines in the psychological management of~     patients who have experienced trauma. The department of psychiatry currently holds a~     Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate~     intervention, prevention and adult services. This research will enable us to gain best~     evidence expertise to develop guidelines as well as a sustainable PTSD treatment program,~     with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare,~     disability and substance abuse.~      The five world-expert-consensus intervention resilience based principles will be~     operationalized in guidelines for the management of trauma patients, their caregivers and in~     routine nursing and trauma team care from the Emergency to the ward, and discharge, through~     to outpatient care. It is hypothesized that this will improve the psychological recovery of~     patients at risk of developing PTSD after a traumatic injury. In addition, early screening~     and intervention for increased risk of PTSD will be implemented one month after the trauma.~     It is hypothesized that such trauma informed psychological management, early screening and~     expert treatment using prolonged exposure will reduce hospital stays, functional disability,~     as well as longer-term psychiatric morbidity, including substance abuse.~   "
80447|NCT02004730|"~     The purpose of this study is to determine whether patients with diffuse or multivessel~     coronary artery disease may benefit from the percutaneous implantation of the device ABSORB~     in larger extent with respect to the general population of patients undergoing percutaneous~     treatment of coronary artery disease.~   "
80448|NCT02004717|"~     This is an open-label, sequential dose escalation and expansion study to evaluate the~     safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced~     solid tumors.~   "
80449|NCT02004704|"~     The primary objective of this study is to obtain data regarding the safety of olipudase alfa~     in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term~     treatment with olipudase alfa.~      The secondary objectives of this study are to obtain data regarding the efficacy of~     olipudase alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics~     (PK) following long-term administration.~   "
80450|NCT02004691|"~     Primary Objective:~      The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa~     (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for~     52 weeks in adult patients with acid sphingomyelinase deficiency (ASMD) by assessing changes~     in spleen volume as measured by abdominal magnetic resonance imaging (MRI) and infiltrative~     lung disease as measured by the pulmonary function test, diffusing capacity of the lung for~     carbon monoxide.~      Secondary Objectives:~      To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52~     weeks.~      To characterize the effect of olipudase alfa on the splenomegaly related symptom score from~     an eDiary after 52 weeks of study drug administration.~      To characterize the effect of olipudase alfa after 52 weeks of study drug administration on~     a symptom based composite score obtained from an eDiary comprising 4 symptom domains (pain,~     fatigue, dyspnea, and splenomegaly related symptoms).~      To characterize the effect of olipudase alfa on liver volume after 52 weeks of study drug~     administration.~      To characterize the effect of olipudase alfa on platelet count after 52 weeks of study drug~     administration.~   "
80451|NCT02004678|"~     DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus.~     This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor~     unblinded), placebo‑controlled, randomized, 2‑part, sequential, single ascending dose,~     single center study to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of single oral dose of DS‑1150b in healthy subjects and subjects with Type~     2 Diabetes Mellitus.~   "
80452|NCT02004665|"~     to evaluate the incidence of delirium in patients with acute coronary syndrome and its~     correlation with adverse events~   "
80453|NCT02004652|"~     The purpose of this study is to evaluate the effect and safety of prucalopride on recovery~     of gastrointestinal function in patient undergoing major gastrointestinal surgery. The~     investigators hypothesize that patients who take prucalopride after major gastrointestinal~     surgery will have shorter duration of postoperative ileus.~   "
80454|NCT02004639|"~     Trismus Prevention, Diagnosis and Management: Radiotherapy Planning, Early detection, and~     Physical Therapy Intervention~   "
80455|NCT02004626|"~     This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind,~     Multicenter, National, Non-inferiority.~      Its purpose is to determine the noninferiority in efficacy of an investigational product in~     relation to the product available in the market intended of treating pressure ulcers.~   "
80456|NCT02004613|"~     Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery~   "
80457|NCT02004600|"~     The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor~     adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and~     recurrent spontaneous or posttraumatic bullous detachment. They are caused by mutations in~     the COL7A1 gene encoding for the collagen VII.~      No curative treatment is avaible. The main cause of patients death is the development of~     squamous cell carcinoma, sometimes multiple and paticularly aggressive in repeated healing~     part. The photodynamic therapy (PDT) is one of technical reference of multiple actinic~     keratoses lesions for adults, which are also pre-epithelioma lesions. The PDT is well~     tolerated even by the elderly and requires only a single session.~      The main objective of this study is to determine the efficiency of the photodynamic therapy~     in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis~     bullosa (DEB). The secondary objectives are to evaluate the tolerance of this treatment in~     terms of pain and healing, and to evaluate the contribution of confocal microscopy in the~     diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic~     epidermolysis bullosa. The main evaluation criterion is the cutaneous biopsy before and~     after (M2) a PDT session of an epidermal dysplasia area. The secondary criteria are the~     evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0,~     M2 and M4 (lesion area and healing time) and correlation histology / MC. Each patient with a~     suspicious lesion will be biopsied. In case of agreement for this protocol, there will be 1~     PDT session followed by a consultation of control at 2 and 4 months after the end of~     treatment.~   "
80459|NCT02004574|"~     The combination of calcipotriol and betamethasone dipropionate used in an ointment~     formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the~     short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation~     (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and~     marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp~     psoriasis vulgaris.~      Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by~     normalizing the reproduction cycle of skin cells. It also relieves itching associated with~     psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp~     psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.~      Since patient compliance is one of the important factors in achieving effective outcomes in~     the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance~     compliance and treatment outcomes as well as to provide a safe and effective therapeutic~     option.~   "
80460|NCT02004561|"~     Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic~     sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure~     selection is made by the patient or patient and guardian. This is not a randomized trial.~   "
80461|NCT02004262|"~     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with~     cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with~     previously treated metastatic pancreatic adenocarcinoma~   "
80462|NCT02004236|"~     Interventional, prospective, randomized, double-blind, placebo-controlled and parallel~     assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of~     intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and~     empathy.~   "
80463|NCT02004223|"~     Current standard treatment for prostate cancer involves giving patients approximately 40~     doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is~     to assess the effects of giving two separate high doses of a special type of precision~     radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy.~      Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy~     prior to commencing a shorter period of standard radiotherapy for prostate cancer.~   "
80464|NCT02004210|"~     The aim of this study is to compare the efficacy of conventional transarterial~     chemoembolization(TACE) and transarterial radioembolization in patients with unilobar~     advanced hepatocellular carcinoma.~   "
80465|NCT02004197|"~     Helicobacter pylori is strongly associated to the development of gastrointestinal disorders.~     Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted~     in significant eradication failure. Clinical trial was conducted to see the efficacy of~     current quadruple and phytomedicine-based therapies for the eradication of H. pylori~     infection and relief in its associated symptoms in Pakistan.~   "
80466|NCT02004184|"~     Non-small-cell lung cancer (NSCLC) accounts for a majority (approximately 85%) of lung~     cancer cases. Patients with localized disease can be cured through surgery, but only 20 %~     are operable.For the majority of patients with advanced disease, palliative cytotoxic~     chemotherapy remains the recommended therapy. Chemotherapy prolongs survival and improves~     quality of life.~      The recommended first-line therapy is 4-6 courses of a platinum in combination with a third~     generation compound (e.g. gemcitabine, vinorelbine, docetaxel, pemetrexed, paclitaxel).~     After first-line therapy, it has been recommended to observe the patients and offer~     second-line chemotherapy at disease progression.~      Regimens for second-line therapy include docetaxel or pemetrexed monotherapy. Pemetrexed is~     less toxic and superior to gemcitabine in non-squamous NSCLC, whereas docetaxel is the~     recommended second-line therapy in squamous cell carcinoma.~      The results of the studies of maintenance pemetrexed therapy are encouraging; the observed~     survival benefit is clinically relevant and relatively large considering the poor survival~     in patients with advanced NSCLC. Furthermore, pemetrexed appears to be well tolerated. There~     are, however, several limitations to the studies that have been conducted: Relatively few~     elderly patients and no PS 2 patients were enrolled - and not all patients on the~     control-arms received pemetrexed at progression.~      The overall aim of this study is to investigate whether immediate maintenance pemetrexed~     therapy prolongs survival compared to observation and pemetrexed therapy at progression in~     patients with advanced NSCLC. Furthermore, it will be explored whether patients with~     'performance status' 2 and elderly ≥ 70 years tolerate and benefit from maintenance therapy;~     and what characteristics and blood biomarkers are associated with sensitivity and~     tolerability of such therapy.~   "
80467|NCT02004171|"~     Electronic cigarettes have shown promise but have yet to proven effective for smoking~     cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers~     who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The~     investigators hypothesize that electronic cigarettes will be comparable to the nicotine~     inhaler in terms of smoking cessation.~   "
80468|NCT02004158|"~     In this proof-of-concept study, the investigators will assess the ease and usefulness of a~     positive psychology program in patients with acute coronary syndrome and less-than-optimal~     adherence to health behaviors. The investigators believe that positive psychology (a field~     that studies boosting positive emotions rather than simply reducing negative emotions) will~     help this cardiac population to be more healthy. The investigators want to determine whether~     this positive psychology program has the potential to be an adjunctive treatment for cardiac~     populations.~   "
80469|NCT02004145|"~     In this study, the investigators will perform an exploratory randomized trial of Positive~     Psychology (PP). The trial will consist of 50 participants and will compare the impact of a~     phone-based PP intervention vs. an attentional control condition, in Major Depressive~     Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is~     a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and~     12 weeks.~      Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP~     intervention in this high-risk population.~      Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP~     and with follow-up data from at least 80% of subjects). The ratings of ease and subjective~     helpfulness of the exercise and other mental states as measured before and after each PP~     exercise will be more than 6 out of 10 and higher than the same ratings obtained from~     subjects in the control condition.~      Specific Aim #2: To examine the impact of the six-session PP intervention on positive~     psychological well-being.~      Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores~     on scales of optimism (measured via the Life Orientation Test-Revised [LOT-R]), gratitude~     (Gratitude Questionnaire-6 [GQ-6]), and positive affect (Positive Affect Negative Affect~     Schedule [PANAS]) at 6 and 12 weeks.~      Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide~     risk factors.~      Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck~     Hopelessness Scale [BHS]; primary study outcome measure), suicidal ideation (SI) (Concise~     Health Risk Tracking scale [CHRT]), and depression (Quick Inventory of Depressive~     Symptomatology—Self Report [QIDS-SR]) at 6 and 12 weeks.~      We will also measure impact on readmission and suicide attempts to assess these key~     outcomes.~   "
80470|NCT02004132|"~     The study involves application of Axiron to each underarm. The study will evaluate the~     transfer of testosterone from underarms to the clothing items that the participant is~     wearing and other fabric items washed with participant's' clothes. The study is~     approximately 6 days, not including screening. Screening is required within 28 days prior to~     the start of the study.~   "
80478|NCT02004028|"~     This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery)~     study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects~     will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days. Pre- and~     post-treatment biopsies and blood samples will be collected. The purpose of this study is to~     assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor~     response rate to VS-6063 (defactinib) will be also be assessed.~   "
80479|NCT02004015|"~     Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis~     (abdominal echography) in the first minutes of after general anesthesia induction.~      Primary End Point: proportion of patients with a score of motion = 0~   "
80480|NCT02004002|"~     The purpose of this proposal is to determine whether dietary protein restriction has~     beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men~     and women.~   "
80481|NCT02003989|"~     HIV patients may suffer sooner from aging than average population, including brain aging.~     Our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in~     HIV patients, this loss could be detected earlier by a thinning down of retinal nerve fiber~     layer (RNFL), compared to non HIV patients of the same age.~   "
80482|NCT02003976|"~     The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving~     optimized non-surgical treatment plus surgical realignment of the tibia, or optimized~     non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months~     follow-up will suggest favourable changes in patients undergoing surgical realignment when~     compared to patients receiving non-surgical treatment only.~   "
80483|NCT02003963|"~     The purpose is to evaluate the feasibility of a 12-week exergaming dance program for~     adolescent girls. This study combines dancing, video games, and a full body work-out to test~     if video games can increase physical activity and promote healthy weight in adolescent~     girls. We hypothesize that girls who play the dance exergames, versus those in the control~     group, will lose weight, decrease body fat and visceral fat, improve cardiovascular health,~     increase physical activity, and improve psychosocial health including self-confidence and~     quality of life.~   "
80484|NCT02003950|"~     Craving differs from hunger because it occurs even when a person is in a satiated state and~     in the absence of an energy deficit. Craving is usually triggered by specific foods and may~     be attributable to certain sensory properties of foods. Foods that are craved are often~     regarded as less healthy choices, and are higher in energy content. Chocolate is one of the~     most commonly reported foods craved by people in this country. Together, craving for~     chocolate has been suggested to be a possible cause of weight gain and access to chocolate~     therefore needs to be restricted.~      However, it remains unknown if restriction may induce maladaptive eating behaviors of~     chocolate cravers. The anticipation of going on a diet has been shown to cause restrained~     and disinhibited eaters to react by consuming more chocolate. In this study, we will examine~     if this response is also found in chocolate cravers when they are asked to undergo three~     weeks of chocolate restriction. This study will also examine chocolate cravers' response~     after the chocolate restriction is lifted. We hypothesize that chocolate consumption of~     cravers will increase both before and after chocolate restriction is imposed. We also~     hypothesize that chocolate craving is specific to the food rather than its sweet taste, and~     that chocolate cravers are less willing to substitute chocolate for salty snacks, natural~     snacks, and sweet non-chocolate snacks during the restriction.~   "
80485|NCT02003937|"~     Spinal muscular atrophy type III, (SMAIII) is a disease in the nerve cells in the spinal~     cord which leads to to progressive muscle weakness and atrophy. No effective treatment is~     available for SMA. We have previously shown that patients with muscular dystrophies improve~     oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning.~     Patients with SMAIII share many clinical features with these conditions, although the~     mechanism of muscle weakness is different. In this study, we investigated how patients with~     SMAIII respond to aerobic training.~      6 patients and 9 healthy age- and sex-matched controls completed a 12 weeks training~     program. Subjects performed a total of 42 training session of 30 min on a stationary cycle~     ergometer at home. The work intensity was moderate and set to match a target heart rate.~      Training induced an increase without inducing muscle damage. However, training-induced~     fatigue was a major complaint in all patients, and caused one patient to drop out, increased~     the need for sleep in three patients and two had to modify the training program.~      The fatigue limits the use of this therapy. The training-induced fatigue, which is not~     encountered in muscle diseases, warrants investigations into alternative training methods to~     improve quality of life in patients with SMAIII.~   "
80486|NCT02003924|"~     The purpose of this study is to assess the safety and efficacy of enzalutamide in patients~     with non metastatic prostate cancer.~   "
80487|NCT02003911|"~     Asthma is a chronic lung condition in children, and often requires hospitalization for acute~     exacerbations. Azithromycin has been used successfully in other chronic lung diseases,~     including cystic fibrosis. Despite limited clinical evidence, some pediatricians use~     azithromycin in children hospitalized with asthma, citing either treatment of atypical~     pathogens or its proposed anti-inflammatory properties. We propose a clinical trial to~     determine if azithromycin will shorten length of stay in children hospitalized with acute~     asthma exacerabations.~   "
80488|NCT02003898|"~     The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic~     MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.~   "
80489|NCT02003885|"~     The purpose of this study is to determine desflurane's dose-dependent effect on left~     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of~     lateral mitral valve annular velocity at three different desflurane concentrations would be~     analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery~     patients~   "
80490|NCT02003872|"~     This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on~     weight loss on obesity and associated co- morbidities.~      The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and~     on related co- morbidities during 1 year of balloon implantation and a year following~     explantation.~   "
82558|NCT01976780|"~     This study aims to assess the degree of artemisinin resistance in adult and pediatric~     subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study~     treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).~   "
80491|NCT02003859|"~     Studies over the past two decades have convincingly demonstrated the role of barrier~     dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that~     optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess~     mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be~     predictive of disease relapse in adult IBD patients. The purpose of the current study is to~     determine the predictive value of pCLE findings in pediatric IBD patients.~   "
80492|NCT02003846|"~     There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal~     intensive care units (NICU) use an underwater bubbling system and others use a ventilator to~     generate the pressure. There is no right or wrong way to generate the pressure and both~     methods are approved and accepted.~      The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on~     each for a defined time period and reviewing the infant's vital signs. The investigators~     expect that the pressure generated by bubble CPAP will be better and lead to improved vital~     signs.~   "
80493|NCT02003833|"~     Anecdotal evidence suggests that patients' skin quality may improve as a result of~     poly-L-lactic acid injection. While this is not the primary goal of such treatments it is~     often seen and described as so called Sculptra glow.~      The aim of this study is to evaluate the effect of repeated subcutaneous injections of~     poly-L-lactic acid (Sculptra Aesthetic) on skin quality.~      Participating subjects will be part of the study for about 15 months. There will be an~     initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There~     will be a total of 7 scheduled visits.~      This study is a double-blind, randomized study. Double-blind means that neither the~     subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo.~     Randomized means that the group subjects will be placed in is decided by chance, similar~     to drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance~     of receiving the active study drug. After the completion of the study, if subjects are~     assigned to the control (placebo) group they will receive free injections with Sculptra~     Aesthetic same as the treatment group.~   "
80494|NCT02003820|"~     We hypothesize that oral hygiene habits in children 8-12 years of age can be improved using~     video format Social Story intervention techniques. The purpose of this study is to~     investigate the effectiveness of video format social stories used to inform and educate~     children and parents about proper dental hygiene technique over a 6 week intervention~     period. We will measure the success of intervention using data collected from clinical exams~     and caregiver/participant surveys. Evaluation of data collected will be used to determine~     the effectiveness of the intervention.~   "
80495|NCT02003807|"~     The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of~     gastrointestinal tract. Therefore there is growing evidence that IBS could occur after~     gastroenteritis. However, little is known about the incidence of IBS after acute~     diverticulitis. We thought that post diverticulitis status could induce IBS because~     diverticulitis was also bowel inflammatory disorder. This survey was designed to identify~     incidence of post-diverticulitis IBS and risk factor in Korea.~   "
80496|NCT02003794|"~     To study the result of intravenous fluid in patients with acute ischemic stroke within 72~     hours.~   "
80497|NCT02003781|"~     Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related~     factors for predicting clinical outcomes in Korean patients with high risk cardiovascular~     disease.~   "
80498|NCT02003768|"~     The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of~     intracranial pressure (ICP). Previous studies have proposed that ultrasonographic~     measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased~     ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial~     pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia~     agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia~     (Des group).~   "
80499|NCT02003755|"~     Cerebral palsy (CP) is a group of disorders of the development of movement and posture but~     often changing motor impairment syndromes. The spastic subtypes are the most common~     manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease~     of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of~     presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with~     CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated~     range of motion could reduce muscle's activation effectively. The polyarticular movement~     training might increase joint range of motion and reduce the muscle activation. But the~     polyarticular movement training is difficulty for some individuals with CP. The single joint~     movement training may achieve the same effect as the polyarticular movement training. The~     purpose of this study was to investigate the effects of continuation passive range of motion~     (CPM) training whether could get the improvement of soleus hypertonia in individuals with~     CP.~   "
80500|NCT02003742|"~     The purpose of the this international, multicenter, randomised, single-blind, parallel~     group, Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided~     intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower~     Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients~     not adequately controlled by medical therapy with α-blockers, as assessed by a change from~     baseline in the International Prostate Symptom Score (IPSS) total score.~   "
80501|NCT02003729|"~     The SIESTA Home Sleep Study is a pragmatic, multi-centre randomized single-blinded two arm~     trial, assisted by a Decision Analytic Model, primarily designed to assess the accuracy,~     effectiveness and cost-effectiveness of diagnosing OSA assisted by ApneaDx™ as compared to~     PSG as a reference standard.~   "
80502|NCT02003716|"~     The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the~     DeFRA as a primary anamnestic from to identify subjects at risk of osteoporosis in a~     population never screened before and never treated for this disease.~   "
80503|NCT02003703|"~     Hepatitis B virus infection is a common occurrence among patients with HIV. Effective~     vaccines are available, but there's some uncertainty regarding specific dosages, specially~     among those who have not responded to an initial vaccination. The purpose of this study is~     to determine the effectiveness of a simplified immunization schedule compared to a high-dose~     one.~   "
80504|NCT02003690|"~     Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed~     suicide in adolescence, and is further associated with poor psychosocial functioning,~     substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for~     other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of~     pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet,~     little is known about effective psychotherapy approaches for this population, and none~     expressly target suicidality. An efficacious, cost-effective psychosocial intervention for~     adolescents with bipolar disorder has great potential to decrease the substantial morbidity,~     mortality and costs associated with adolescent bipolar disorder.~   "
80505|NCT02003677|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect~     of the investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in~     geriatric and younger adult subjects with type 1 diabetes.~   "
80506|NCT02003664|"~     This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the~     efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence.~     The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of~     cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine~     brain mechanisms of relapse/recovery, participants will complete fMRI sessions before,~     during, and after treatment. Brain responses to specific probes of reward and inhibition~     will be used as biomarkers predicting drug use during and after the treatment.~   "
80507|NCT02003651|"~     The primary objective of this study is to evaluate the effectiveness of ingesting an~     alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately~     following each onset of acute respiratory illness (ARI) symptomatology during a 12-week~     period in the winter and early spring in women.~      Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period~     will experience reduced ARI symptomatology, both acutely during each ARI episode and~     collectively over the entire 12-week study period.~   "
80508|NCT02003638|"~     This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and~     favorably affect circulating levels of endothelial progenitor cells and microparticles in~     people with atherosclerotic disease on chronic statin therapy.~   "
80509|NCT02003625|"~     This research study is evaluating a drug called meloxicam to see if it provides a benefit to~     people receiving Autologous Hematopoietic Stem Cell Transplantation (AHSCT).~      The participant is currently scheduled to receive an AHSCT, which is a procedure that~     removes blood-forming stem cells (cells from which all blood cells develop) from the body.~     These stem cells are stored and later given back to the participant by a process called~     apheresis. This is a standard procedure to treat certain blood diseases such as lymphoma and~     multiple myeloma. However the use of meloxicam with this procedure is considered~     investigational.~      Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) which is given to decrease~     fever, swelling and pain that may come with inflammation. It has been approved by the FDA~     for the treatment of arthritis however it has not been approved for use in people receiving~     AHSCT.~      This study will compare the combination of meloxicam with a drug called G-CSF (also called~     neupogen), to the combination of G-CSF with an agent that has no medicine (placebo). G-CSF~     is a substance that causes blood stem cells to change or increase in number when given to~     people undergoing AHSCT. The researchers would like to learn if giving meloxicam in~     combination with G-CSF to people before they undergo AHSCT will increase the number of stem~     cells available in the blood to collect and make the collection process easier.~   "
80510|NCT02003612|"~     A retrospective analysis of historical data looking at hematological remission and survival~     in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.~   "
80511|NCT02003599|"~     Breast neoplasm is the second most common type in the world. Radiation therapy is a key~     component in the treatment of breast cancer. Acute skin reaction is one of the most common~     side effects of radiation therapy. Several studies were performed for prophylaxis of this~     adverse event, however, until this moment there is no consensus for clinical practice .~     Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an~     agent capable of repairing damage to DNA or agents that promote cell proliferation . The low~     power laser promotes tissue repair ( reduces inflammatory phase and induces collagen~     synthesis ) . Its use in the treatment of adverse events of cancer treatment is well~     established in two situations : in the prophylaxis and treatment of mucositis and in the~     treatment of lymphedema . The purpose of this study is to use the low power laser in~     patients with breast cancer undergoing radiotherapy treatment to evaluate the effects of~     Laser InGaAIP 660Nm in preventing radiodermatitis.~   "
80512|NCT02003586|"~     The study is designed to determine the extent to which foods containing a plant-based~     ingredient affect blood glucose and hormonal response in healthy subjects.~   "
80513|NCT02003573|"~     Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety~     and pharmacokinetics of different volasertib administration schedules in combination with~     decitabine in previously untreated AML patients >= 65 years of age who are considered~     ineligible for standard intensive therapy, or patients with relapsed or refractory AML~     regardless of prior treatment status.~      MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of~     volasertib in combination with decitabine in previously untreated patients with AML >= 65~     years of age and considered ineligible for standard intensive therapy.~   "
80514|NCT02003560|"~     The purpose of this study is to determine in a phase II clinical trial whether accelerated~     partial breast irradiation after breast conserving surgery using 3 dimensional external beam~     radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive~     breast cancer patients is safe without causing serious late radiation side-effects.~   "
80515|NCT02003547|"~     A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3~     Ophthalmic Formulations of AMA0076 in Healthy Subjects~   "
80516|NCT02003534|"~     This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle~     glaucoma and ocular hypertension.~   "
82559|NCT01976767|"~     Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls~     in terms of clinical features, physiological measurements and non-invasive measurement of~     biomarkers and develop phenotype handprints for adults with severe asthma~   "
80517|NCT02003521|"~     We hypothesized that the ability of the Lung Flute to enhance mucus clearance from the lower~     airways could be used to improve asthma control, if the device is used on a chronic basis.~     The primary end point of the study is the comparison of Asthma Control Test (ACT) - a~     validated questionnaire for asthma control and exhaled NO before, during and after using the~     lung flute. Several secondary end points were assessed for efficacy and safety, including~     health status, spirometric lung function, stepping down controller therapy and daily~     albuterol use.~   "
80518|NCT02003508|"~     This study will examine how common HPV infection is in teenage males in Australia before and~     after the introduction of universal school based vaccination of males in Australia.~   "
80519|NCT02003495|"~     The purpose of this observer-blind study is to evaluate the safety, reactogenicity and~     immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6~     years-old children.~   "
80520|NCT02003482|"~     Anatomical changes that take place during Intensity modulated radiation therapy (IMRT)~     treatments for cancers of the head and neck cause significant dosimetric changes.~   "
80521|NCT02003469|"~     Background and Rationale Cardiovascular disease is highly prevalent in the kidney transplant~     population, accounting for approximately 40% of all deaths and significant morbidity. The~     morbidity and mortality experienced by kidney transplant recipient's results from an excess~     of pre-transplant risk factors that are exacerbated by kidney transplantation along with the~     development of novel risk factors. Hypertension (HTN) is the most consistent cardiovascuar~     disease risk factor in transplant recipients..~      A large number of studies have been done in the general population comparing ambulatory~     blood pressure monitoring (ABPM) to casual, office based and home measures of blood pressure~     (BP). The results have clearly demonstrated that ABPM gives a more accurate representation~     of BP and arguably should be used as part of routine patient care. ABPM has been shown to~     reveal patients both with white-coat and with masked HTN, nocturnal HTN and lack of~     nocturnal dipping. Ambulatory BP measures afford us a non-invasive, highly accurate way to~     evaluate and treat kidney transplant recipients.~      Live kidney donors (LKD) have significantly expanded the supply of critical organs. Of~     paramount importance of course has always been donor safety. As a result, candidates are~     known to be healthy at the time of donation. Ambulatory blood pressure monitoring allows a~     unique opportunity to examine the effects of live kidney donation on the blood pressure~     profiles of LKD.~      Methods Study Design: Prospective, 5-year, single center study of ABPM, cardiovascular and~     graft outcomes in incident and prevalent live kidney donors, kidney and kidney-pancreas~     transplant candidates and recipients.~   "
80522|NCT02003456|"~     Positron emission tomography (PET) scans can be used to evaluate whether parts of the heart~     muscle are alive but receiving inadequate blood supply. This study involves the use of two~     radiotracers that will measure whether heart muscle cell are alive and quantify the blood~     supply to the heart muscle.~   "
80523|NCT02003443|"~     The primary objective of this project is to determine whether self-administered acupressure~     is an effective and feasible self-management strategy for older adults with symptomatic KOA.~     Participants will be randomized to three treatment groups: pain-relief acupressure, sham~     acupressure, and usual care (UC). The two acupressure groups will be taught to administer~     pain-relief and sham acupressure, respectively, on themselves 5 days/week for 8 weeks. The~     usual care group will not be required to change any of their treatment practice. Outcome~     data will be collected at baseline, and the 4th and 8th week after baseline.~   "
80524|NCT02003430|"~     The purpose of this study is to investigate the association between the Independent~     Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA)~     and poor tolerance to radiation treatment in older and younger patients with non-ovarian~     gynecological cancers.~   "
80525|NCT02003417|"~     This study will evaluate the proportion of prostate cancer patients receiving external beam~     radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars~     (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total~     cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing~     radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary~     and preventive care as well as patient-reported quality of life and satisfaction with care~     among these patients will be evaluated at baseline and 12 months.~   "
80526|NCT02003404|"~     This purpose of this study is to look at three commercially available ostomy barriers on~     peristomal (around the stoma) skin. Repeated barrier application and removal over years~     causes changes to the skin that the investigators wish to investigate. The primary objective~     is to measure peel force on normal skin and peel force on peristomal skin, with the intent~     of determining if differences occur. The study hypotheses is that no differences exist.~   "
80527|NCT02003391|"~     The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with~     travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with~     open-angle glaucoma or ocular hypertension.~   "
80528|NCT02003378|"~     Some patients' heart rates do not increase as needed during activities and exercise, which~     can make them feel tired and fatigued easily. The patients in this study have a pacemaker~     with a FDA approved rate response sensor, which senses activity level by sensing motion~     (through a component known as an accelerometer) and/or breathing changes (known as minute~     ventilation). These changes in motion or breathing make the pacemaker increase the patient's~     heart rate. This study is being conducted to see which rate response sensor is better~     (motion driven or breathing driven). The study is also investigating whether optimizing the~     sensor based on the individual patient will give better results in terms of increasing the~     patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the~     minute ventilation sensor results in improved functional capacity compared to accelerometer~     in chronotropically incompetent patients.~   "
80552|NCT02003053|"~     Inspiratory muscle training (IMT) is an intervention used with success in the outpatient~     setting within the COPD population. Use of IMT is also theoretically possible during~     mechanical ventilation. This study will determine if the IMT excercise will increase Maximum~     Inspiratory Pressure and will also assess the feseability and safety of the study.~   "
80553|NCT02003040|"~     The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day~     hospital readmissions for acute decompensated heart failure. Secondary outcomes will include~     correlation with NT-proBNP and weight both at admission and discharge from hospital~   "
80529|NCT02003365|"~     This study will be an open-label, single administration design, conducted in patients with~     OA of the knee.~      Patients will be enrolled sequentially with 8 to 10 patients per Cohort as follows:~      Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16~     Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12~     Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12~      Each patient will be evaluated for up to 12, 16 or 20 weeks following a single~     intra-articular (IA) injection of FX006 at 10 mg or 40 mg or TCA IR 40 mg, depending on the~     assigned Cohort. Following the screening visit, safety will be evaluated at three (3)~     out-patient visits and synovial fluid will be collected at Day 1 for baseline measurements~     and the Final Visit for drug concentration measurements.~   "
80530|NCT02003352|"~     Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering~     from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators~     will study PTSD treatment in military Veterans who have suffered traumatic brain injuries.~     Investigators will use 1 independent specialty treatment centers that utilize a specific~     novel methodology of PTSD treatments and study the clinical outcomes of veterans who have~     suffered a TBI with associated post-concussive symptoms and other comorbidities such as~     PTSD. Investigators hypothesize that the treatment of PTSD will have a significant outcome~     with neurological physical and vestibular rehabilitation when compared to psychological or~     psychiatric therapy. This study will use gold standard measurement scales and compare~     changes in the scales after treatment to evaluate the treatments.~   "
80531|NCT02003339|"~     For patients who are suffering from hepatocellular carcinoma and are treated with~     radioembolization, the purpose of this study is to analyse parameters of functional MRIs~     that are modified early and to detect parameters that vary significantly after treatment.~   "
80532|NCT02003326|"~     The objective is determine the strain measured at the bedside could be a dynamic prognostic~     marker of during Acute respiratory Distress Syndrome (ARDS).~   "
80533|NCT02003313|"~     The purpose of this double-blind study is to evaluate the safety, reactogenicity and~     immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30~     years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135~     Meningococcal Polysaccharide Vaccine.~   "
80534|NCT02003300|"~     The primary aim is to confirm the efficacy of a new non-invasive method for measuring the~     oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary~     bypass. The method has already been successfully tested in the laboratory under controlled~     conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for~     comparison purposes, from monitoring measurements made routinely as part of normal patient~     care in these cases, using a pulmonary artery catheter - an invasive technique from which~     severe complications occasionally arise, including death.~      A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor,~     isoflurane, during this kind of surgery.~   "
80535|NCT02003287|"~     The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation~     of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration~     when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants~     in the NICU. A secondary objective is to determine whether FEES can be used to detect~     laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.~   "
80536|NCT02003274|"~     BACKGROUND. Optimal glucose control can prevent/relent tissue damage in patients with type 1~     diabetes mellitus (T1DM). Ongoing efforts aim at developing closed loop control (CLC)~     algorithms linking subcutaneous continuous glucose monitoring (CGM) and insulin delivery~     (CSII). Substantial improvement towards an effective artificial pancreas system is still~     needed, especially in the regulation of post-meal glucose. Application of metabolic control~     analysis (MCA) can unveil and quantify distortions in the system properties of the~     glucose-insulin (pump) system (GIS), by measuring the coefficients of control (CCs) of~     glucose. Our approach rely on previous experience with our previous pilot protocol~     (NCT01800734).~      AIM. We will outline and compare features of GIS in T1DM patients and in healthy controls~     during differently sized breakfast meals and during 24-hour periods. The reproducibility of~     our approach will also be assessed.~      METHODOLOGY. Three protocols will be carried out. All T1DM patients will be on CGM/CSII~     therapy. In all three protocols, study 1 will be an euglycemic insulin clamp in T1DM~     patients and a frequently sampled intravenous glucose tolerance test (IVGTT) in healthy~     controls.~        -  Protocol 1: 10 T1DM patients on CGM/CSII and 10 control subjects will ingest a mixed~          meal of different size (320 and 640 kcal) on two separate occasions.~        -  Protocol 2: 5 T1DM patients will ingest two repeat 320 kcal meals, whereas other 5 T1DM~          patients will ingest two 640 kcal meals on two separate occasions.~        -  Protocol 3: 10 T1DM patients and 10 controls will be monitored for 24 hours, during~          which they will ingest 3 mixed meals.~      Substrate (including CGM)/hormone responses will be measured in all studies. Comprehensive~     single meal and 24-hour models of GIS will be built, MCA will be applied and the CCs of~     glucose assessed, thereby allowing to outline and to compare the CCs of glucose between~     patients and controls.~      EXPECTED RESULTS. Our data will be of use in devising novel clinical strategies in T1DM,~     including, but not limited to, development and refinement of CLC algorithms along the path~     towards an effective artificial pancreas system.~   "
80537|NCT02003261|"~     This study is to examine the superiority of the combined treatments of transdiagnostic~     cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with~     the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms~     among depressive and anxiety disorders.~   "
80538|NCT02003248|"~     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate~     Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of~     Parkinson's Disease (PD)~        -  Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated~          with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD~        -  Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial~          MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV~          for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate~          treatment.~      This study is designed as a prospective, single-site, single arm, nonrandomized study.~     Assessments will be made before and three months after MRgFUS for clinical symptom relief,~     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative~     Safety will be evaluated using a common description of Significant Clinical Complications~     for patients treated in this study. This study will be performed on the 3T MR scanners.~   "
80539|NCT02003235|"~     The study will evaluate the effect of Reviview™, a dichoptic video display device for~     administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.~      The effect of the treatment will be measured by the change from baseline in Visual acuity~     and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.~   "
80554|NCT02003027|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT~     Storm.~   "
80540|NCT02003222|"~     This randomized phase III trial studies combination chemotherapy with blinatumomab to see~     how well it works compared to induction chemotherapy alone in treating patients with newly~     diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase~     (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     blinatumomab, may block cancer growth in different ways by targeting certain cells. It is~     not yet known whether combination chemotherapy is more effective with or without~     blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.~   "
80541|NCT02003209|"~     This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab~     with estrogen deprivation to see how they work compared to docetaxel, carboplatin,~     trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone~     receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer~     that is operable or has spread from where it started to nearby tissue or lymph nodes~     (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab,~     and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving more~     than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the~     growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase~     inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor~     cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination~     chemotherapy and radiation therapy with or without hormone therapy may be an effective~     treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast~     cancer.~   "
80542|NCT02003196|"~     Morbidity and mortality of ICU patients is increased by the development of a~     immunosuppression systemic (IS). This IS develops in the early hours of hospitalization~     and is responsible for severe infections, including viral reactivations (Cytomegalovirus or~     Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and~     mortality in intensive care units. In clinical practice, they are searched at the onset of~     organ failure or unexplained fever. The investigators wish to conduct this research in the~     stroke patients to assess the predictive power of these viral reactivations on the duration~     of mechanical ventilation.~   "
80543|NCT02003183|"~     The project is designed to assess early diagnosis of Chronic Traumatic Encephalopathy (CTE),~     a neurobehavioral syndrome manifested by failed relationships, marriages, and businesses,~     emotional disturbances, depression, alcohol and substance abuse, and suicide attempts and~     completions. CTE typically begins after a latency period of several years following single~     or repeated Traumatic Brain Injuries (TBIs). A history of cerebral concussion may or may not~     be present.~      This study builds upon prior work at UCLA using Positron Emission Tomography (PET) to~     identify normal and abnormal functional patterns in the brain by studying persons with a~     history of TBI including but not limited to: amateur and professional athletes, active and~     veteran members of the armed forces, as well as victims of motor vehicle and work accidents,~     and physical battery/domestic violence.~      This project aims to expand these findings to the population at large. Identification of the~     syndrome is critical for identifying potential individuals who are most likely to benefit~     from potential prevention and treatment.~   "
80544|NCT02003170|"~     The purpose of this study is to systematically evaluate the results of medical~     investigations to identify symptom and biological patterns and common etiologies of~     neurodevelopmental disorders.~   "
80545|NCT02003157|"~     The purpose of this study is to compare the clinical benefits that can be expected by the~     Embryo transfert procedure with hypnosis to the usual embryo transfer procedure~   "
80546|NCT02003144|"~     The purpose of this study is to determine whether eculizumab long-term use is safe and~     effective in patients with relapsing NMO.~   "
80547|NCT02003131|"~     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived~     mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or~     injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for~     inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4~     radiographic OA severity.~   "
80548|NCT02003118|"~     This proof of concept study will be a placebo controlled, randomised, double blind, parallel~     study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of~     osteoarthritis (OA) pain in the knee.~   "
80549|NCT02003092|"~     The purpose of this Phase 1 study is to determine the maximum tolerated dose of RX-5902 in~     subjects with advanced or metastatic solid tumors.~   "
80550|NCT02003079|"~     Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the~     cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates~     mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities.~     As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot~     function properly, which can lead to recurrent infection and swelling of the sinus walls.~     When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis~     (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial~     pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number~     of individuals in Canada and has been found to be associated with poor quality of life. In~     the CF population the life expectancy is increasing but chronic disease like CRS is becoming~     increasingly prevalent. Investigators currently do not know the impact that CRS has on the~     health-related quality of life in adults with CF and how many suffer from symptoms. The~     investigators aim to determine the impact of CRS among adults with CF, in order to gain a~     better understanding of chronic disease among these individuals. The investigators strongly~     feel this research will improve the referral processes between Respirologists and~     Otolaryngologists, thereby improving treatment and quality of life for patients.~   "
80551|NCT02003066|"~     Investigators hypothesized that goal-directed fluid therapy using stroke volume variation~     will improve postoperative recovery in patients undergoing free flap reconstruction after~     head and neck cancer resection. Investigators will compare the effect of goal-directed fluid~     therapy using stroke volume variation on recovery in patients undergoing free flap~     reconstruction after head and neck cancer resection.~   "
80560|NCT02002949|"~     The purpose of this randomized study is to determine if the home SDHD is a suitable~     alternative to conventional dialysis performed in a dialysis center for patients suffering~     from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).~      The adequacy of this alternative dialysis technique confirms that the SDHD at home is a~     viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of~     home SDHD compared with those of conventional dialysis: lowering blood pressure and lower~     use of antihypertensive drugs , improving the quality of life, maintenance of residual renal~     function related to a reduced risk of death and reduction in operating costs of dialysis and~     patient transport.~   "
80561|NCT02002936|"~     This is an extension study to investigate long term safety and efficacy of SyB C-1101 when~     orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who~     have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of~     SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory~     myelodysplastic syndrome.~   "
80562|NCT02002923|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different treatment strategies, PVI only versus PVI~     plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed~     after follow-up of at least 1 years with the use of an implanted monitoring device (IMD).~   "
80563|NCT02002910|"~     To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR)~     guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG)~     guide change and to analyze the cost-effectiveness of its dual diagnosis.~      To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score~     evaluated physiological assessment of coronary stenosis and its clinical effectiveness.~   "
80564|NCT02002897|"~     The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new~     modality for treatment of localized scleroderma and to compare its results with the well~     established method of UVA 1 phototherapy.~   "
80565|NCT02002884|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of one or both arms alone or in combination with injections into one or both legs~     are effective and safe in treating children/adolescents (age 2-17 years) with increased~     muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.~   "
80566|NCT02002871|"~     Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of~     treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be~     screened up to 28 days before start of treatment. During the screening visit, the purpose~     and procedures of the study will be explained to potential patients and informed consent~     will be obtained. In addition, fungal superinfection of the target area will be examined~     using direct preparations and mycology cultures. At the baseline visit, patients with Eczema~     will be determined and all inclusion and exclusion criteria will be assessed. For eligible~     patients, two comparable treatment areas will be randomized to treatment with blue light~     (target area) or to serve as untreated control area. After randomization, patients will~     receive treatment of the target area with 3 applications per week at the investigational~     site for a total treatment period of 4 weeks. During those 4 weeks, safety and effectiveness~     assessments will be performed at weekly intervals. After end of treatment, the patients will~     be followed-up for another 2 weeks. In case no full resolution of adverse events occurred at~     the 2 week follow-up visit, a follow-up call will be performed after another 2 weeks.~     Treatment responses will be photo documented~   "
80567|NCT02002858|"~     The primary aim of this research study is to enhance smoking cessation outcome among smokers~     with elevated anxiety and depression. We are comparing two group treatment approaches: (1)~     An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An~     integrated smoking cessation, and anxiety and depression management treatment program~     (SDAT). Both treatments also utilize nicotine replacement therapy.~   "
80568|NCT02002845|"~     A retrospective multicenter investigation of the use of the da Vinci® Surgical System in~     Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and~     effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor~     procedures.~   "
80569|NCT02002832|"~     A randomized, double-blind, double-dummy, parallel-group and multicenter study to~     investigate lurasidone in treatment of schizophrenia compared with risperidone~   "
80570|NCT02002819|"~     Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory~     and other mental functions (referred to as cognitive functions). The seizures, and other~     examples of overactive electrical activity in the brain that is not noticeable, contribute~     to the loss of cognitive function. Studies in animal models of AD suggest that a drug that~     prevents seizures called levetiracetam may reduce neuronal over-excitation and improve~     cognition. Based on this evidence, the investigators propose to determine if levetiracetam~     can be used to treat patients with AD. The investigators developed novel instruments for~     this population that will also be used in future large-scale clinical trials.~      The current study will last for 12 weeks and will involve people with AD. Participants will~     be initially examined with an overnight brain wave study to assess for silent epileptic~     (seizure-like) activity. Presence of epileptic activity on the screening exam is not~     required to enter the trial. Participants will then be assigned to groups in a randomized~     manner. One group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then~     placebo for 4 weeks. For another group, the order of treatments will be reversed. The~     cognitive abilities of participants will be retested every 4 weeks and compared to those at~     the beginning. The cognitive tests include a virtual-reality navigation test of memory and~     computerized tests of mental flexibility and problem solving. The participants will be~     monitored with a magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit.~     M/EEG is a highly effective non-invasive method for identifying brain regions of epileptic~     activity. The investigators will need to recruit 36 randomized participants to test the~     study hypotheses. This study will take place at the University of California, San Francisco~     (UCSF) Memory and Aging Center, which is a large referral site for dementias, and the~     Department of Radiology. The overall goal of the study is to demonstrate that levetiracetam~     provides cognitive benefit in AD, particularly in patients who have silent epileptic~     activity.~   "
80571|NCT02002806|"~     This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo~     for pain control in subjects with pancreatic cancer.~   "
80572|NCT02002793|"~     This study aims to standardized the process of mini-invasive abdominal draniage of SAP in~     early stage.To determine the indications and occasion.~   "
80626|NCT02002091|"~     -  It is a prospective,observational, cohort study~        -  The main purpose of the study is to assess the prevalence of diabetic chronic~          complications in newly diagnosed type 2 diabetics in suburban area of Algiers.~        -  The secondary purpose is to study the impact of diabetic renal complications as a risk~          factor on the atherothrombotic events.~   "
80573|NCT02002780|"~     This research project has two goals. The first goal is to find one or more questionnaires~     that can accurately identify children who are experiencing high levels of stress or~     emotional health issues during a regular clinic visit. The second goal is to find out~     whether children who are experiencing stress or emotional health problems are able to attend~     a day camp programme and complete activities at home that are designed to help them cope~     better with stress. We also want to find out if the day camp and home activities are~     helpful.~   "
80574|NCT02002767|"~     This study is to evaluate the single-dose pharmacokinetics (PK), safety, and tolerability of~     GS-5816 in participants with severe renal impairment using matched healthy participants as a~     control group.~   "
80575|NCT02002754|"~     This study aim is to observe the response to Bambuterol Hydrochloride tablets treatment in~     subjects with eosinophilic bronchitis .~      The investigators hypothesize:~      A few of subjects with EB have some responses to Bambuterol Hydrochloride tablets therapy.~      Most of subjects with CVA respond well to Bambuterol Hydrochloride tablets therapy~   "
80576|NCT02002741|"~     The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to~     ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.~   "
80577|NCT02002728|"~     The purpose of this study is to evaluate a methodology for detecting early forming cavities~     in children that is more accurate and reliable than the gold standard used by dentists~     around the world. The new method uses an electrical current device to detect early enamel~     mineral loss before it can develop into a cavity. The manual gold standard is for a dentist~     to probe the surfaces of the teeth with a fine pick, searching for areas of defect.~   "
80578|NCT02002715|"~     This study aims to observe the therapeutic effect of different treatment course with inhaled~     corticosteroids in eosinophilic bronchitis patients.~      The investigators hypothesize:~        1. Cough score will be improved after treatment with longer treatment course with inhaled~          corticosteroids in EB patients.~        2. The sputum eosinophil percentage will be decreased and recovered to normal level~          (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients.~        3. The rate of recurrence after treatment will be decrease with longer treatment course~          with inhaled corticosteroids in EB patients~   "
80579|NCT02002702|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety,~     tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and~     30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy,~     in approximately 45 Japanese AHF patients.~   "
80580|NCT02002689|"~     The purpose of this signal seeking study is to determine whether treatment with LDE225~     demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic~     malignancies to warrant further study~   "
80581|NCT02002676|"~     Patients in critical illness frequently present hypermetabolism， which can extremely~     increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely~     increased REE will improve ICU patients' outcome~   "
80582|NCT02002663|"~     The aim of the study is the identification, comparing continuous infusion of local~     anesthetics and steroids intralesionally with the current gold standard therapy (PCA), of~     the effective dose of local anesthetics and steroids within 7 days following abdominal~     surgery in order to halve the consumption of opioids and give the best pain control with a~     lower incidence of side effects and persistent chronic pain (at 1 and 3 months) We also plan~     to measure the peripheral inflammation and oxidative stress by analyzing the~     pro-inflammatory cytokines and anti-inflammatory properties.~      Another objective is to investigate the combined effect of polymorphisms of genes related to~     pain sensitivity, and the correlation with the development of the inflammatory response and~     the incidence of chronic post-surgical pain (CPSP), which will be considered to validate the~     genotype-phenotype correlations.~      The intralesional catheter will be placed within the operating field by the surgeon at the~     end of the procedure.~        -  first postoperative 24 hours: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion~          (10ml/h) in the wound. Rescue dose with morphine via intravenous PCA (0.5 mg/ml, bolus~          1 mg, lock-out 5 min, max 20 mg in 4 hours)~        -  from 24 hs to 48 hs: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion (10ml/h)~          or saline 0.9% 10 ml/h in the wound. Rescue dose with morphine via intravenous PCA (0.5~          mg/ml, bolus 1 mg, lock-out 5 min, max 20 mg in 4 hours) . from 48 hs to 7th day:~          ropivacaine 0.2% or saline 0.9% via patient controlled intralesional analgesia (PCIA)~          (2 mg/ml, bolus 20 mg, lock-out 60 min, max 80 mg in 4 hours). Rescue dose Tramadol 100~          mg.~      The first assessment will be by the anesthetist pre-operatively, to verify the patient~     eligibility.~      All patients will be evaluated at the end of surgery (T0) and after 3-6-12-24-36-48 hours~     after surgery. Further evaluations are scheduled every 24 hours until the seventh~     postoperative day. At each assessment will be recorded: Numeric Rating Scale (NRS) at rest,~     NRS at movement (NRSm) - defined as pain at deep inspiration and cough - ; blood pressure,~     heart rate, respiratory rate, nausea (PONV scale), need of rescue analgesics and presence of~     any complications.~      On the 7th postoperative day, the patient will be reassessed by both pain clinicians and~     surgeon; the surgeon will remove the catheter.~      At 1 month and 3 months after surgery, the patient will be evaluated through phone interview~     to investigate pain persistence.~      Inflammatory response analysis will be performed on the first 15 patients in each group (for~     a total of 30 patients). Before awakening of the patient the surgeon will insert a~     microdialysis catheter in the fat adjacent to the surgical wound with sterile technique. The~     microdialysed liquid will be collected in dedicated tubes directly in the infusion pump. The~     sample of the first hour will be discarded to avoid that microtrauma of catheter positioning~     influences the study. Sampling will be performed every 6 hours the first day, and every 12~     hours in the second and third day. Serum samples will be collected to compare systemic with~     regional samples. All samples will be stored at -80 ° C until sampling. Concentrations~     quantification of different cytokines will be analyzed by ELISA Parma Unit will analyze VNTR~     (variable number of tandem repeats) polymorphism of the ADRB2 gene, directly related to the~     risk of chronic persistent postoperative pain development; Pavia Unit will take care of~     genotyping of polymorphic sites in the following genes: OPRM1 (mu-opioid receptor 1), COMT~     (catecholamine O-methyl transferase), UGT2B7 (UDP-glucuronyl transferase), IL1Ra~     (interleukin 1receptor alpha). From the blood samples will be extracted DNA and RNA using~     standard procedures. RNA will be retained for possible future studies on the expression of~     genes of interest. The DNA will be used instead for the study of genetic polymorphisms.~      In this study the formation of free radicals, particularly superoxide will be assessed~     together with lipid peroxidation in both serum and urine, The 8- deoxyguanosine and~     Poly-ADP-ribose polymerase (PARP), the presence of nitrotyrosine.~      Blood samples and urine tests will be carried out before the start of surgery , before the~     bolus of morphine and local anesthetic , at 24 h after the end of the intervention and 48 h~     after end of the intervention~   "
80583|NCT02002650|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. However, the risk~     factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not~     just for selected high-risk patients, may preventing PEP maximum. The purpose of this study~     is to determine whether routine using of rectal indomethacin is more effective than the~     conditional strategy.~   "
80584|NCT02002637|"~     The objective of this study is to evaluate the safety and technical feasibility of~     implanting the Latella Implant System in the treatment of patients with medial~     osteoarthritis of the knee.~   "
80585|NCT02002624|"~     The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the~     clinical and radiologic results of primary total knee arthroplasty (TKA) using~     patient-specific versus conventional instrumentation.~   "
80586|NCT02002611|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     lobeglitazone and warfarin in healthy subjects.~   "
80587|NCT02002598|"~     This study is designed to define dose-limiting toxicity and determine preliminary evidence~     of efficacy of Carfilzomib (CFZ) in combination with bendamustine and dexamethasone for~     patients with newly diagnosed multiple myeloma (MM).~   "
80588|NCT02002585|"~     Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use~     of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney~     disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone.~     Renal denervation is a modern endovascular method used to treat resistant hypertension. The~     method is being extended to other groups of patients, where the sympathetic tone is~     increased beyond resistant hypertension. Because of the character of the disease, we~     hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney~     functions in this patient population. The aim of this clinical study is to show that renal~     denervation has protective effects on the progression of chronic renal insufficiency.~   "
80589|NCT02002572|"~     The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU~     Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs~     (Technological University of Compiègne). The question raised is the extent to which a facial~     mimic can be evaluated objectively. In today's clinical practice, the investigators use~     grading systems based on muscular scale or testing, in order to evaluate a facial muscular~     disorder. This assessment remains subjective because the investigators are deducing from~     surfacing cutaneous deformations the movement quality of the solicited muscle.~      This qualitative approach is therefore an approximate approach and deserves to be better~     thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation~     of facial palsy, cleft palate for example), to monitor the results, and to follow the~     recovery and progress in physiotherapy care.~      The aim of this study is to correlate external soft tissue movement (essentially cutaneous)~     during facial mimic with internal movement (essentially facial mimic muscle) using~     qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected~     mimic face's movement using the precedent data.~   "
80591|NCT02002546|"~     1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I~          as measured by the i-STAT immunoassay reliably identifies and excludes an acute~          myocardial infarction.~        2. In chest pain patients with suspected acute coronary syndrome whose baseline troponin~          is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured~          by the i-STAT immunoassay accurately discriminates between acute myocardial infarction~          and non-acute myocardial infarction troponin elevations.~   "
80592|NCT02002533|"~     This randomized phase II trial studies how well brief behavioral therapy works in improving~     sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep~     disorder counseling may reduce fatigue and insomnia as well as improve the well-being and~     quality of life in patients with breast cancer who are undergoing chemotherapy.~   "
80593|NCT02002520|"~     Pain is the way our brain interprets certain bodily sensations. It is very difficult to~     describe or to put into words as perception and tolerance of pain varies widely between~     individuals. It is known that age, gender and past experience and memory of past experience~     all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why~     some patients actually do not experience any pain at all post surgery is still unknown.~      Because pain affects every person at some point in their lives, it is of utmost importance~     that we can find more effective analgesic methods, and provide analgesia tailored to an~     individual's need as well as discovering new methods which may be able to identify those~     individuals who are more prone to suffering serious, or chronic pain. It has been proposed~     that epigenetic modifications may play a role in sensitivity to analgesia and response to~     trauma, such as post surgery. The effects of epigenetic changes on key genes and the role~     this plays in analgesia sensitivity and pain perception is deserving of further research.~      Epigenetics is a growing field of study in which there are genetic modifications that do not~     involve changes to base sequences in a gene, but that result nonetheless in changes to gene~     expression. It has long been known that changes in gene expression play an important role in~     the establishment of pain states. But it is not known whether a priming injury can induce~     lasting epigenetic marks which would result in an increase in both postoperative acute pain~     and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will~     we be able to offer better drugs for the treatment of pain, and to identify those at high~     risk of postoperative pain and postsurgical chronic pain.~      The purpose of this study is to determine whether severity of pain following surgical~     procedures, such as third molar surgery is related to baseline methylation status of the~     promoter region of IL-6 and TNF-α and changes in methylation status post surgery.~   "
80594|NCT02002507|"~     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park~     bench position when compared to the supine position. There will also be a change in blood~     flow between the right and left internal jugular veins in the park bench position. In~     particular, there will be a greater reduction of flow on the dependent side. However, the~     internal jugular venous flow will be the same in both the prone and supine positions.~   "
80595|NCT02002494|"~     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park~     bench position when compared to the supine position. There will also be a change in blood~     flow in the between right and left internal jugular veins in park bench position,~     particularly there will be a greater reduction of flow on the dependent side. However, the~     internal jugular venous flow will be the same in both the prone and supine position.~   "
80596|NCT02002481|"~     Investigation of the influence of narrowness and unusual circumstances on the CPR-quality~   "
80597|NCT02002468|"~     Denmark has a higher incidence of cervical cancer than other Nordic countries, although all~     Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or~     asymptomatic invasive cancer.~      Annually 40 000 women receives an abnormal or inadequate test result and a follow-up~     recommendation.~      However problems with delayed follow-up may threaten the effectiveness of the Danish~     Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can~     progress into cancer.~      Delayed follow-up is found in situations where women either consciously or unconsciously~     postpone follow-up, or because of organizational aspects of the screening program, where~     communication regarding test results can fail either in content or with delay.This study~     will evaluate two interventions designed to increase follow-up:~        1. A letter with the test result and potential recommendation for follow up will be sent~          to the women (RCT). The intention is to ensure that all women will be notified about~          the test result, quickly, homogenously and in layman's written language, still with the~          opportunity to contact or be contacted by the general practitioner, if there is special~          needs. Furthermore, it is assumed that general practitioner consultations regarding~          delivery of normal test results will decrease, so that cost savings is a potential side~          benefit~        2. Electronic reminder to the general practitioner if women have not had the recommended~          follow up, giving the general practioner´s an opportunity to remind the women (retro~          perspective cohort study).~      The results will be of great importance to the future organisation of cervical and~     colorectal cancer screening programmes in Denmark, but will also have international interest~     because of their similar challenges.~   "
80598|NCT02002455|"~     Prostate cancer (PCa) is currently the most common neoplastic disease among men in~     well-developed countries with 350 000 new cases diagnosed annually in Europe and 4 800 in~     Finland. Due to widespread use of serum prostate specific antigen (PSA) in asymptomatic men,~     most patients present initially with localized disease. Radical prostatectomy, radiotherapy~     (RT) and active surveillance are the most common management options for patients with~     localized PCa. Proper preoperative staging for patients with adverse features on biopsy who~     are candidates for radical prostatectomy is urgently needed. For elderly men external beam~     RT is the preferred modality which can be safely performed utilizing modern techniques such~     as intensity modulated and image guided radiotherapy (IMRT and IGRT). Since randomized~     studies suggest a dose response effect beyond 78-80 Gy newer techniques aim at dose~     escalation provided that toxicity can be controlled. Therefore, ultra high dose IMRT/IGRT~     requires visualization of intracapsular disease which will receive the highest dose. Taken~     together, the use of accurate anatomical and functional imaging modalities are essential for~     planning both nerve sparing radical prostatectomy and ultra high dose IMRT/IGRT Fluorine-18~     labeled L-leucine analogue 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) has shown~     to preferentially accumulate in PCa and its nodal metastases. By assisting in localization~     of intraprostatic and pelvic disease FACBC with hybrid positron emission tomography/computed~     tomography (PET/CT) or magnetic resonance imaging (PET/MRI) has potential to improve~     selection of patients for robot-assisted radical prostatectomy and IMRT/IGRT.~      Anatomical MRI at 1.5 Tesla (T) compared with transrectal ultrasound has demonstrated a~     higher sensitivity for tumor detection but almost the same specificity, stressing the need~     for additional metabolic MRI. Advanced application of MRI such as proton magnetic resonance~     spectroscopy (1H MRS), diffusion weighted imaging (DWI) and dynamic contrast enhanced~     imaging (DCE-MRI) are increasingly being used for detection and characterization of PCa. The~     use of 3T scanners and multiparametric MRI (mpMRI), consisting of anatomical MRI, DWI, 1H~     MRS and DCE-MRI, demonstrated very promising result for staging and detection of PCa.~   "
80599|NCT02002442|"~     The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse~     with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or~     saline solution on bacterial contamination in the buccal vestibule when used preoperatively~     using the real-time Polymerase Chain Reaction (qPCR).~      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater~     reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or~     saline mouthwashes.~      The secondary aim of this study is to evaluate the effect of the tested mouthwashes in~     reducing the bacterial counts over time.~      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a~     reduction of bacterial counts for longer duration than with essential oil-based,~     cetylpyridinium chloride, or saline mouthwashes.~   "
80600|NCT02002429|"~     Background: Facet interventions are the second most commonly performed procedure in pain~     clinics throughout the U.S, including in the military. Currently, there is no clear~     consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint~     nerve; MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not~     to perform diagnostic/ prognostic blocks.~      Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select~     patients for radiofrequency denervation.~      Purpose: Objective 1: Determine which prognostic block is the best predictor for RF~     denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may~     provide intermediate or long-term benefit to a subset of individuals.~      Research Design: Randomized, comparative-effectiveness study~      Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back~     pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of~     3 groups:~      Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids~     and LA Group 3 will receive MBB with only saline~      Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (<~     1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In~     group 3, those patients who do not experience pain relief at 1-month will undergo RF~     denervation regardless of the pain relief they experience (as many practitioners in the~     military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1~     and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and~     steroids will not undergo RF denervation until their pain returns. Those individuals who~     experience prolonged relief lasting > 6 months will be given the option of repeating the~     diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief~     from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after~     the block, or until their pain relief wears off. In those who undergo denervation based on a~     positive block, follow-ups will be performed 1, 3 and 6-months after the denervation~     provided they continue to experience significant (> 50%) relief at each follow-up. Those~     individuals who fail to experience significant relief after denervation will be unblinded~     and exit the study per protocol.~   "
80601|NCT02002416|"~     The MET oncogene encodes the receptor tyrosine kinase (RTK) for hepatocyte growth factor~     (HGF) and controls genetic programs leading to cell growth, invasion and protec¬tion from~     apoptosis. Although the definitive role of MET oncogene is yet to be determined in~     carcinogenesis of gastric cancer, overexpression and amplification of c-Met has been~     demonstrated in gastric cancer cell lines. In addition, approximately 10-20% of gastric~     cancer tissues and up to 40% of the scirrhous histological subtype were shown to harbor~     increased MET gene copy numbers. Importantly, PHA-665,752, a selective c-Met kinase~     inhibitor showed significant reduction of established tumor mass in mouse xenografts with~     GTL16, a gastric cancer cell line with >10-fold MET amplification. Another pivotal study~     showed that gastric cancer cells with MET amplification were extremely sensitive to~     PHA-665,752 and implicated a potential role of c-Met protein in developing theranostics in~     gastric cancer. More and more data indicated that c-Met was an important prognostic factor~     in gastric cancer.~      Gastric cancer is a heterogeneous disease. Does the expression and amplification of c-Met in~     the primary lesion differ from the metastatic disease? Does the expression and amplification~     of c-Met in the early disease differ from advanced disease? Till now there is no related~     report.~      Purposes:~        -  Compare the expression and amplification of c-Met between primary lesion and metastatic~          lesion together with clinical characteristic, to explore the relationship of c-Met~          expression and metastatic pattern~        -  Compare the expression and amplification of c-Met between early stage and metastatic~          stage, and to explore the role of c-MET in the development of carcinoma~   "
80602|NCT02002403|"~     The drug being tested in this study is low doses of Optina (formerly known as Danazol)~     (DMI-5207) that may be an effective treatment for diabetic retinopathy and diabetic macular~     edema (DME). Laboratory studies have demonstrated that low doses of this drug may treat~     diabetic retinopathy and diabetic macular edema by two important ways, decreasing blood~     vessel permeability (related to leaking and edema) and by decreasing the formation of new~     leaky blood vessels. Optina is not approved by Health Canada for the treatment of diabetic~     macular edema but higher doses of Optina are approved by Health Canada for treatment of~     endometriosis (growth of cells similar to those that form inside of the womb that grows~     outside of the womb) and fibrocystic breast disease (a condition of the breast tissue).~     Higher doses of Optina have also been approved in the United States and many other countries~     since the mid-1970s in the treatment of men and women with hereditary angioedema (a disease~     which causes swelling in parts of the body) in addition to endometriosis and fibrocystic~     breast disease in women.~      All of the Optina doses that will be used in the current study are less than half of the~     typical starting doses for the approved indications. This can be compared to high-dose~     aspirin that is used to treat, for example, headache, while low-dose baby aspirin is used~     to reduce blood clotting. Similarly, Optina has two different effects at high and low dose.~     The low doses for this study have been selected based on the laboratory studies mentioned~     above.~      The purpose of this study is to investigate the safety and effectiveness of low doses of~     Optina in the treatment of macular edema due to diabetes, and also to test if it helps to~     slow the development of macular edema.~   "
80603|NCT02002390|"~     Stroke is one of the main severe disease of public health importance. Increasing evidence~     suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets~     are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator~     Fingolimod(FTY720)is an effective immunology modulator which has been widely used in~     autoimmune disease and has been testified effective on stoke animal models.~   "
80604|NCT02002377|"~     SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in~     patients with wet age related macular degeneration who have incomplete response with~     routineranibizumab treatment.~   "
80605|NCT02002364|"~     In patient who are predicted to be difficult to intubate with a standard direct laryngoscope~     well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i).~     Patients are randomly assigner to a single- or a multiple- use flexible optical scope.~      We hypothesize that intubation is obtained equally effective with both types of flexible~     scopes~   "
80606|NCT02002351|"~     This monocentric registry should provide information on the extent how patients with~     pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation~     treatment. The data may provide a basis for further prospective studies showing the~     treatment of patients with pulmonary diseases especially by physical activation.~   "
80607|NCT02002338|"~     A study to research the post-operative results according to the chosen surgical technique~     and evaluate the refractive changes before and after the excision of pterygium.~   "
80608|NCT02002325|"~     The purpose of this study is to clarify efficacy and safety of MRI-based intravenous~     thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having~     acute ischemic stroke with unknown time of symptom onset.~   "
80609|NCT02002312|"~     To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with~     advanced clear cell renal cell carcinoma using RECIST criteria.~   "
80612|NCT02002273|"~     The objective of this randomized study is to compare the effect of two controlled chest tube~     protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or~     segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous~     studies have suggested that the amount of negative pressure used at the level of the chest~     drainage device may affect the duration of air leak, but the results have been inconsistent,~     however as revealed in more recent studies understanding of the physics of chest drainage~     devices may have been confounded by lack of regulation of the pleural pressure.~      In addition, experimental studies have shown that fluid drainage may be affected by the~     degree of negative pleural pressure applied.~   "
80613|NCT02002260|"~     This study is a randomized clinical trial comparing the levonorgestrel intrauterine system~     (LNG-IUS) to combined oral contraceptives (COCs) for treatment of heavy menstrual bleeding.~     This study is designed to be conducted within the context of a patient's~     standard/usual/typical care from their primary gynecologic care provider. We hypothesize~     that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related~     quality of life and will be associated with fewer treatment failures and greater~     cost-effectiveness at one year. To test these hypotheses, we plan to enroll 59 women from~     several sites who present for gynecologic care and self-report heavy menstrual bleeding into~     a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy~     menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic~     disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or~     COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.~   "
80614|NCT02002247|"~     The aim of the investigators' research program is to investigate the effects of~     perioperative high dose selenium supplementation in high-risk cardiac surgical patients~     undergoing complicated open heart surgery. The investigators hypothesize that the~     therapeutic strategy tested in this randomized trial may contribute to a fewer~     complications, less organ injury and fewer deaths. Before the investigators conducted the~     large definitive trial, they conducted a pilot study to assess the feasibility of the~     protocol, and are rolling the pilot patients into the definitive trial.~   "
80615|NCT02002234|"~     A single-centered, randomized, controlled clinical trial comparing standardized medical care~     alone with standardized medical care and decompressive hemicraniectomy to determine the~     effectiveness of decompressive surgery more definitively in patients with clinical signs of~     infarction of the Middle Carotid Artery (MCA) territory.~   "
80616|NCT02002221|"~     The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid~     add-on therapy to improve overall glycemic control in patients with T2DM inadequately~     controlled by insulin, with or without concomitant metformin treatment. It was agreed with~     PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety~     data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.~   "
80617|NCT02002208|"~     The purpose of this study is to determine whether OC000459 is in reducing disease severity~     and preventing flares in people with moderate to severe atopic dermatitis (AD).~   "
80618|NCT02002195|"~     Elderly patients are generally underrepresented in the study populations of combination~     chemotherapy trials. In gastric cancer patients, oxaliplatin has shown a more favorable~     toxicity profile than cisplatin. A combination chemotherapy of 5-fluorouracil (5-FU) with~     oxaliplatin, mainly FOLFOX regimens, has been investigated in numerous phase II studies,~     using different doses and schedules, and has shown considerable antitumor activity. Insofar~     as toxicity is concerned, significant toxicities, including myelo-suppression and peripheral~     neuropathy, are a major issue for elderly patients. A modified FOLFOX regimen by omitting~     the administration of bolus 5-fluorouracil have shown a good profile of activity and~     tolerability in the elder population. This study evaluates the efficacy and safety of a~     modified FOLFOX (m FOLFOX) regimen for up to 8 cycles followed by capecitabine maintenance~     in elderly patients with metastatic gastric cancer and presenting associated disease(s)~   "
80619|NCT02002182|"~     Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus~     (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases~     in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx~     cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is~     surgery and/or radiotherapy with or without chemotherapy. While chances of survival for most~     patients with HPVOPC is very good, current treatments are associated with short- and~     long-term side effects which can be severe. In pre-clinical research using animal models of~     cancer, vaccination targeting the HPV virus has been found to cause tumor regression. Thus,~     approaches which target the unique characteristics of HPV-infected cancer cells, such as~     therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and~     chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease~     control.~      The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in~     stimulating the body's defense system against HPV-positive oropharyngeal squamous cell~     carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001~     uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically~     modified such that the risk of getting an infection is significantly reduced. Several~     research studies have already been conducted with ADXS11-001 in men and women with cancer.~     So far, approximately 675 doses of ADXS11-001 have been given to 263 patients with HPV~     associated cancers.~   "
80627|NCT02002078|"~     Corrosive substance ingestion in childhood is a public health issue in developing countries~     and several management protocols were proposed to prevent esophageal strictures. The role of~     corticosteroids in preventing corrosive-induced strictures is controversial. The~     investigators' aim is to study the influence of high doses of corticosteroids to prevent~     esophageal strictures.~   "
80628|NCT02002065|"~     The purpose of this follow-up study is to evaluate the five-year immune persistence of one~     injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.~   "
80642|NCT02001883|"~     The primary objective of this study is to compare the efficacy and tolerability of low-dose~     statin therapy vs. the association between a low-dose statin and a nutraceutical-based~     protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be~     at high-risk.~   "
80620|NCT02002169|"~     Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis~     (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit~     showering but not increase infection risk.~      Research question: Is it feasible to conduct a randomized control trial comparing the rate~     of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC~     care alone with 6 month follow up? Study Design: This pilot study is a multi-centre~     randomized control trial. Eligible participants will be randomized to STP versus standard~     care after meeting predefined criteria to confirm healed tunneled CVC exit site.~      Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the~     CRB rate documentation in the satellite setting, percentage of patients screened, recruited,~     educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated~     patients in the control arm).~      Study Setting: In satellite units affiliated with 2 academic and 3 community centres in~     south central Ontario, Canada.~      Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit~     sites.~      Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each~     measure of feasibility has its statistical threshold for success. If the threshold is~     reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.~      Discussion: A pilot feasibility study of the larger study is critical due to the potential~     challenges associated with recruitment, compliance and contamination.~   "
80621|NCT02002156|"~     The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent~     tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more~     effectively to a subsequent infection with TB.~      Many studies have shown that BCG is effective in reducing deaths from TB disease,~     particularly in children. However, there is also evidence that in countries with a~     relatively high death rate, BCG reduces this death rate but by more than would be expected~     by its effect on TB alone. This controversial but important finding warrants further and~     serious consideration. One possibility is that BCG, in addition to stimulating the immune~     system against TB, also has a positive effect on the way the immune system works more~     generally. This might mean a more effective response to serious infections that are~     completely unrelated to TB, or the ability to respond better to other routine childhood~     vaccines, or to maintain such responses for longer. In these examples, the timing of BCG~     administration in relation to other vaccines could be crucial.~      This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine~     in the UK within the first week of life. Babies will be assigned at random to one of three~     groups of ten babies each. BCG will be given to one group of babies around birth, one at~     three months old and the last group will not get BCG during the study. Babies will stay in~     the study until 13 months old and have five blood tests over this period.~      This preliminary study will look at the participants' blood to see if there are differences~     in the immune system, or its response to the MenC childhood meningitis vaccine or the~     pattern of genes activated after BCG has been given.~   "
80622|NCT02002143|"~     Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in~     those aged over 65 years. Treatment such as medication, healthy nutritional choices & body~     weight management, as well as physical activity can reduce the impact of diabetes.~      Older patients with type 2 diabetes can potentially benefit from Group Appointments, in~     which 8-12 patients share one appointment of about 60-120 minutes with a team of health~     professionals.~      The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their~     key measure of success will be control of glycosylated hemoglobin - HbA1C.~      To address their primary and secondary research objectives the investigators will focus upon~     patients aged 65 years or older who have T2DM and who are being treated with oral~     hypoglycemic agents and diet, or diet alone.~      The investigators will compare patients randomized to (A) eight Group Appointments over a 24~     month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B)~     patients randomized to eight traditional one-to-one usual care appointments also provided by~     a primary care physician (Individual Appointment; [Control]). The investigators will compare~     (A) and (B) on selected clinical, patient-rated, and economic outcome measures.~      SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for~     physicians who lead Group Appointments. If the study's proposed health care innovation~     demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province-~     or nation-wide in Primary Care settings.~   "
80623|NCT02002130|"~     Type I Diabetes is an auto immune disease in which the body's immune system attacks and~     destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by~     this condition present with high blood sugars. This condition affects 1:400/500 persons~     worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in~     childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has~     been no treatments that can arrest, or reverse the ongoing beta cell destruction. We~     hypothesize that GABA, a naturally occurring substance, has the potential to reduce the~     inflammation and protect the pancreatic beta cells from autoimmune destruction. GAD-alum may~     contribute to the preservation of residual insulin secretion in patients with recent onset,~     Type I Diabetes.~   "
80624|NCT02002117|"~     The logical next step is to integrate molecular profiling into the care of all patients with~     NSCLC.~   "
80625|NCT02002104|"~     The replacement of autologous blood vessels by artificial grafts is urgently needed in~     clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most~     clinically used artificial blood vessels because of its chemical and mechanical stability.~     But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts~     have a high failure rate of 40% in three years in vivo because of the functional lack of an~     intact endothelial cell layer. Here we developed a two-step modification including chemical~     etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg.~     cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE~     grafts. Functional peptide immobilization significantly increased the adherence and growth~     of HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to~     evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days~     implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were~     demonstrated by SEM and histological analysis. These preliminary data showed the potential~     to grow an intact endothelial layer to improve the patency rate of the modified ePTFE~     grafts.~   "
80629|NCT02002052|"~     Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable~     non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately~     30%, and is associated with a decline in pulmonary quality of life.~      Standard radiation planning aims to optimize dose to the anatomic lung volume, without~     consideration of the differences in regional lung function. Functional lung avoidance~     radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead~     depositing dose in areas of lung that are not well-ventilated. Functional lung regions are~     determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans.~     Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial~     aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs.~     functional lung avoidance radiotherapy (with concurrent chemotherapy).~   "
80630|NCT02002039|"~     Whether Erythropoietin improves the neurological outcomes of neonates with perinatal~     asphyxia.~   "
80631|NCT02002026|"~     This trial will address the effect of uterine artery ligation during Cesarean section in~     cases with placenta previa to decrease blood loss.~   "
80632|NCT02002013|"~     Translating reliable evidence on fluid resuscitation of intensive care patients into~     clinical practice - Improving patient outcomes and containing public health costs~   "
80633|NCT02002000|"~     Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in~     general practice. The possible causes are numerous and sometimes nonspecific. In some cases,~     the etiologic investigation of patients with non-systematized and chronic musculoskeletal~     pain can not highlight any organic cause. Several studies have shown a link between these~     symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D <~     20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D~     supplementation with few side effects. Nevertheless, it remains unknown and vitamin D~     deficiency is rarely considered as a possible etiology in patients with chronic pain. We~     hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal~     pain and deficient in vitamin D could improve painful symptoms. We aim to perform a~     double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain~     improvement after vitamin D supplementation.~   "
80634|NCT02001987|"~     This two part, multi-center, open-label, single-arm study will evaluate the efficacy and~     safety of RoActemra/Actemra as a monotherapy or in combination with non-biologic disease~     modifying antirheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid~     arthritis who have an inadequate response or are intolerant to non-biologic DMARDs or~     biologic therapy. 162 mg RoActemra/Actemra will be administered once a week by subcutaneous~     injection for up to 76 weeks.~   "
80635|NCT02001974|"~     This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile~     of orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal~     growth factor receptor-2) negative metastatic breast cancer patients.~   "
80636|NCT02001961|"~     This will be a cross-sectional, observational study.~      Null hypothesis:~      There is no difference in the amount of extracellular volume (ECV or scarring) in the hearts~     of patients with heart failure as compared to control subjects.~      Heart failure occurs when the heart muscle has become too weak to work properly. It is~     associated with an increase in the amount of connective tissue (collagen) which replaces~     dead heart muscle cells (scarring). Currently a biopsy of the muscle is the only way to~     measure the amount of scarring. This is invasive and rarely done in children. Because of~     this, it is difficult to measure the amount of scarring in a particular patient or disease~     process, which is important for improving our understanding and treatment of the disease.~      Cardiac magnetic resonance imaging (MRI) is a non-invasive imaging tool which is routinely~     used to look at areas of local scarring in heart muscle. Because the scarring is so~     widespread in paediatric patients, we have not been able to use this method previously. Now~     new imaging techniques allow us to look at widespread scarring but these have not yet been~     validated in children.~      We plan to use late gadolinium enhancement (T1 mapping) to measure the amount of scarring in~     patients with heart failure (we have evidence that their heart biopsies show increased~     amounts of scar tissue) and children having MRI scans for other reasons. We will use~     measures of function including echocardiography and 6 minute walk test to compare to the~     amount of scarring. This will help us to know whether the amount of scarring will be~     clinically useful.~      We will look at the amount of various proteins in the blood of patients and control subjects~     which are related to the scarring and cell death processes. We already use blood tests to~     monitor heart failure and these tests may help us to refine our testing and improve timing~     of treatment (e.g. transplantation).~      This study will help us to design further research in this field.~   "
80637|NCT02001948|"~     The aim of this study was to compare the effects of two different doses of intrathecal~     morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative~     block regression times, postoperative analgesia and the severity of side effects, for~     inguinal hernia repairs.~   "
80638|NCT02001935|"~     The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms~     effect metabolism of theophylline in chronic obstructive pulmonary disease patients.~   "
80639|NCT02001922|"~     Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory~     disorder characterized by acute exacerbations that contribute to physical impairment and~     increased healthcare use and costs. Given the increasing burden of this disease in terms of~     morbidity, disability, mortality and costs, innovative care models centered on patients and~     aiming at improving quality and comprehensiveness of care are needed. Effective~     implementation and evaluation of chronic disease management - integrated care(CDM-IC)~     programs, in the real world context is of great importance.~      Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility~     and effectiveness of a community-based CDM-IC program for COPD patients residing in the~     canton of Valais.~      Design: The evaluation plan of this study will combine both quantitative (controlled~     before-after study design) and qualitative methods (focus groups with COPD patients and~     practicing healthcare professionals).~      Setting: French-speaking part of the canton of Valais.~      Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease,~     non-institutionalized and residing in the canton of Valais. The control group of patients~     will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort~     study.~      Measures:~      Quantitative part:~      Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause~     hospitalizations (past 12 months)~      Other outcomes:~        1. Processes of care~        2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC~          instrument)~        3. Measure of self-efficacy (intermediary outcome)~        4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers~        5. Healthcare utilization: unscheduled ambulatory care visits~        6. Care satisfaction~        7. Measures of the process of implementation of the intervention~      Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients,~     and of two focus groups of participating healthcare professionals.~   "
80640|NCT02001909|"~     To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy~     male subjects~   "
80641|NCT02001896|"~     This 2 arm study will compare the efficacy and safety of treatment with erlotinib~     intercalated with platinum-based therapy or erlotinib along, as first line treatment in~     Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor~     (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1~     , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day~     from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by~     erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is~     until disease progression, and the target sample size is 60 individuals.~   "
80643|NCT02001870|"~     As age increases the chances for a woman to become pregnant decrease as well spontaneously~     as through assisted reproductive technologies (ART). For the treatment of unexplained~     infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro~     fertilization (IVF). The aim of the present study is to compare the efficiency in term of~     delivery rate of IUI and IVF in couples in whom the female age is over 37 years.~   "
80644|NCT02001857|"~     Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph~     node involvement in prostate and bladder cancer. The main complication of PLND is~     development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or~     penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or~     infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles~     following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as~     Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue~     sealing. They could reduce lymphocele development by increased tissue sealing, due to a~     mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin~     and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r)~     in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND~     with bladder cancer surgery.~   "
80645|NCT02001844|"~     Modern modular foot-orthoses systems allow an integration of the cost and efficiency~     benefits afforded by the use of pre-formed semi-rigid FOs components, while simultaneously~     allowing a high degree of individualisation of prescription. Such systems, while popular,~     still remain unproven. Recent studies in paediatric rheumatology have made a contribution in~     developing guidelines with regards to pharmacological intervention in arthritic children. In~     addition, specific drug therapy protocols have been published to effectively help general~     practitioners, physiotherapists and ophthalmologists to successfully treat children with JIA~     patients (BSPAR 2006; Hull 2001; NICE guidelines 2002). A Cochrane systematic review on~     treatment of pes planus, highlighted that children with JIA were excluded as a group from~     most of the studies (Ashford et al. 2005). At present little evidence exists for the~     podiatric management of children affected by this disabling pathology, especially for~     orthotic management. This research has provided evidence to support the use of readily~     available off-the-shelf FOs in treating JIA children.~   "
80646|NCT02001831|"~     The aims of the present study are:~      i. To conduct a population study of body composition, muscle function and ability to~     undertake activities of daily living in elderly Irish individuals~      ii. To investigate the effect of a six month period of nutrition supplement support on lean~     tissue mass, and muscle and cognitive function in individuals aged 70 to 80 years.~   "
80647|NCT02001818|"~     The treatment of CML and the expected survival has been revolutionised since the~     introduction of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their~     effectiveness, these drugs will never totally remove CML affected cells from the body. In~     order to achieve this goal, and potentially enable CML patients to live without the daily~     need for TKIs, other features of the patient's immune system may need to be harnessed. One~     possibility is using externally administered interferon (IFN) to augment the response~     induced by the TKI.~      This study will assess the response in terms of length of survival, detection of minimal~     disease levels and time until disease worsens in patients with chronic phase CML who are~     taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3~     months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2~     years. Patients can continue taking nilotinib beyond this time providing they are receiving~     benefit. Options are available for patients to decrease or increase their dose or to switch~     to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side~     effects is achieved.~   "
80648|NCT02001805|"~     The investigators wish to compare very active runners in healthy untrained control subjects~     on a number of parameters.~      The project aims to understand the underlying mechanisms by which physical inactivity causes~     diseases. This the investigators will study the full spectrum of physical activity, from the~     most inert of the most active people. The investigators have already collected muscle~     biopsies and established stem cells from people with Type 2 diabetes, obese healthy and~     normal weight healthy. In this study, the investigators will establish a cohort of highly~     physically active marathon runners. In a case-control design, the investigators compare~     muscle stem cell function across the entire spectrum of physical activity / inactivity.~   "
80649|NCT02001792|"~     The purpose of this study is to determine the effects of patient positioning during~     colonoscopy on patient safety and diagnostic outcome.~   "
80650|NCT02001779|"~     Stenting the malignant biliary obstruction is considered to be the preferred palliation~     modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical~     indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated~     the safety and technical feasibility of an irradiation biliary stent insertion in patients~     with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in~     relieving jaundice and extending survival when compared to a conventional biliary~     stent.However,the small sample size,the population distribution of two groups will influence~     the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric~     study was designed to prospectively compared the responses to the treatment with this~     irradiation biliary stent versus the conventional biliary self-expandable stent in patients~     with inoperable malignant biliary obstruction.~   "
80656|NCT02001701|"~     Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It~     is due to an abnormal separation of the vitreous gel from the surface of the retina and~     macula. The current, gold-standard treatment for this condition involves surgery performed~     in the operating room that involves risk such as bleeding, infection, cataract, and retinal~     detachment. It has been previously shown that a less invasive intravitreal injection of a~     gas bubble performed in the office may also treat vitreomacular adhesion with less risk than~     surgery.~      The purpose of this study is to determine the effect of an office-based injection of an~     intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.~   "
80657|NCT02001688|"~     To evaluate different doses of Kamada-API for Inhalation on the levels of alpha~     1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to~     assess the safety of the treatment in subjects with Alpha-1 Antitrypsin Deficiency.~   "
80651|NCT02001766|"~     Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor~     tissue perfusion and function as well as an increased risk of cardiovascular events. ATP,~     which is released from the red blood cells, contributes to the regulation of the blood flow~     and studies have shown that red blood cells taken from T2D patients have an impaired ability~     to release ATP. However, it is not known whether the changes in the ATP system is an~     underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is~     to test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced~     release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will~     normalize ATP release, plasma ATP levels and thereby blood flow.~      Furthermore, epidemiological studies show a clear link between regular exercise and a~     reduced risk of serious cardiovascular disease. The extent to which a physically active~     lifestyle may improve endothelial function in T2D is unknown. Regular physical activity~     improves vascularization and induces an anti-inflammatory environment. Both the angiogenic~     and anti-inflammatory effects of physical activity is in part mediated by substances~     released from the active muscle. These muscle-derived substances are classified as myokines~     and have paracrine, autocrine and endocrine effects and may thereby affect distant tissues.~     The purpose of the project 2 is to investigate whether high intensity interval training may~     reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In~     individuals with T2D we will determined blood flow in the muscle tissue using advanced~     ultrasound. In addition, using intravascular and intramuscular microdialysis we will~     determine ATP levels in blood and in the muscle interstitium.~   "
80652|NCT02001753|"~     Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical~     diagnostic imaging tool. By using a static and a gradient magnetic field in combination with~     a radiofrequency field (RF), MR provides excellent contrast among different tissues of the~     body. Although long-term effects on human health from exposure to strong static magnetic~     fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure,~     reversible arrhythmia, and neurobehavioural effects have been documented from occupational~     exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest~     switching electromagnetic gradients available in MR exposing the patients to the highest~     administered energy levels accepted by the controlling authorities. Studies focusing on~     experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since~     CMR is emerging as one of the fastest growing new fields of broad MR application, it is of~     particular concern that a recent in vitro study with CMR sequences has reported on~     CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR.~     Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial~     progenitor cells in type 2 diabetes~   "
80653|NCT02001740|"~     Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to~     affect 25% of the general population. Many forms of treatment have been advocated for frozen~     shoulder including physiotherapy, injection with steroid, distension arthrogram with~     steroid, manipulation under anesthetic and arthroscopic releases. There is no general~     agreement in favour of one form of treatment, and the response to a particular treatment~     varies in different series. A few randomized controlled trials appear in the literature.~     Most of these showed improvements with steroid use, but the results were not always~     statistically significant. One randomized control trial reported superior results in favor~     of arthrographic joint distension with steroid compared to a saline placebo. To our~     knowledge there have been no other similar randomized trials to support these results. The~     objective of this study is to determine if arthrographic distension of the shoulder joint~     with steriods is an effective treatment modality for adhesive capsulitis as compared to~     injection with local anesthetic and contrast alone. The study design is a~     placebo-controlled, double blind clinical trial where participants will undergo distension~     arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid),~     lidocaine and contrast or injection with lidocaine and contrast alone.~   "
80654|NCT02001727|"~     Aims:~        1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on~          the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on~          dyspepsia related health-care consumption and quality of life.~        2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination~          of these conditions and the effect on quality of life, prognosis and dyspepsia-related~          health care expenditure.~      Methods:~      In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration~     number, were allocated by a computerized randomized procedure to HP-screening group and~     control group. All participants received a questionnaire at inclusion, 1-year and 5-year and~     now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In~     addition we will obtain information from registers on, comorbidity, use of endoscopies and~     prescription medication. An economic evaluation is done alongside the randomized trial.~      The primary unscreened group is invited to HP test (13C-urea breath-test) in order to~     analyze the effect of HP-screening according to HP-status~      Expected results:~      The study will provide information on the long-term effect of HP-screening and eradication~     in a population. The study will provide information about the long-term effect on incidence~     of peptic ulcer in an aging population that is likely to have an increased consumption of~     ASA and NSAID. Furthermore the study will generate knowledge about the long-term prognosis~     of dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from~     the 5-yr follow-up (13) showed that is has a great influence on quality of life and the~     dyspepsia-related health care consumption, whether the individual has solely reflux, solely~     dyspepsia or a combination of both symptoms.~      Long-term follow-up and further analyses of these findings could have great impact on~     management and treatment of individuals with symptoms. It is important to focus on groups;~     in which the symptoms have the greatest influence on quality of life of the individual. This~     finding has not been displayed in other studies.~   "
80655|NCT02001714|"~     This three-site randomized controlled trial compares the effectiveness and~     cost-effectiveness of a group-administered behavioral treatment program to no treatment.~     Women with stress, urgency, or mixed urinary incontinence will be recruited and screened~     centrally, evaluated clinically at each of three study sites, and random assigned to one of~     two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment~     modalities have the potential to reach a larger population of older women with urinary~     incontinence, not only in the traditional medical settings, but also in community settings.~     The investigators hypothesize that group behavioral treatment will be more effective than no~     treatment. The investigators hypothesize that the group treatment will be cost-effective~     compared to no treatment.~   "
80692|NCT02001233|"~     The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and~     safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total~     10,000 healthy infants volunteers aged from 6 to 35months old.~   "
80816|NCT01999621|"~     Investigators will evaluate determinants of the patients' care type : palliative, medical or~     intensive care. The place of patient or family on care's decision will be noticed.~     Investigators will evaluate 3 month-survival and patients' feelings (visit with a~     psychologist) according to type of care they benefited.~   "
80658|NCT02001675|"~     Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring,~     maintaining and/or enhancing muscular performance. From a practical point of view, NMES can~     elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism)~     or by the recruitment of motoneurons in the spinal cord through the depolarization of~     sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the~     balance between transmission along these two pathways. Conventional NMES is usually~     delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and~     high stimulus intensities so that the large antidromic volley in motor axons ensures that~     the evoked contraction will be driven largely by the direct depolarization of motor axons~     beneath the stimulation site with no or little involvement of central nervous system. On the~     contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to~     100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism~     and the corresponding force (recently referred to as extra force) is significantly (three~     times) larger than the conventional NMES-induced force. This extra force is supposed to~     represent the central contribution from the recruitment of spinal motoneurons by the evoked~     afferent volley given that no additional force was observed during a complete anesthetic~     block of the nerve proximal to the stimulation site. Despite the obvious differences in~     terms of activation of the neuromuscular system between conventional and WP-HF NMES, the~     functional, metabolic and cortical responses associated to both protocols remain to be~     determined~   "
80659|NCT02001662|"~     The investigators want to explore the analgesic effect of Adductor Canal Blockade (a~     peripheral nerve block) in high pain responding patients after arthroscopic knee surgery.~     The investigators hypothesize that the nerve block will have an abrupt analgesic effect.~   "
80660|NCT02001649|"~     Suicidal behaviors is known to aggregate in families. The purpose of this study is to~     evaluate association between common polymorphisms in genes important for neurobiological~     pathways linked to suicidal behaviors and suicide attempt among adolescents patient.~   "
80661|NCT02001636|"~     Obese patients, who underwent bariatric surgery, are at risk to develop protein~     malnutrition. The aim of this study is to evaluate the influence of postoperative protein~     supplementation on weight reduction, body composition and protein status.~   "
80662|NCT02001623|"~     The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed~     population of patients with specified solid tumors~   "
80663|NCT02001610|"~     Commercial probiotics can be delivered in numerous forms. The two most common delivery forms~     are similar to the two product formats to be tested. It has been demonstrated using in vitro~     testing that probiotic organisms that are unprotected from gastric exposure may not survive~     that exposure and therefore may not remain viable throughout the rest of the GIT.~     (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro~     testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule~     will survive gastric exposure. It is anticipated that this difference in in vitro gastric~     survivability will translate to improved digestive tract survivability that can be~     demonstrated using fecal recovery techniques.~      The commercial product to be tested in this clinical trial has been in the market for over~     17 years. However, it is not known what effect this commercial product has on the commensal~     probiotic population in the gut and particularly in the lower bowel where much of probiotic~     benefits are believed to be largely realized. Also, it is not known what effect the~     commercial product has on the total commensal microbiota or fecal pH. While commercial~     probiotic products have been largely aimed at benefits related to improved health, they also~     have the potential to change overall gut microbiota (probiotics as well as all others)~     composition and activities. Learning what happens to the overall gut microbiota can be a~     helpful step in establishing the potential health benefits of the probiotic class of~     organisms in the test products.~   "
80664|NCT02001597|"~     Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment~     for prostate cancer. The state of the art radical prostatectomy involves a robotic~     laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D~     visualization of the surgical site and improved dexterity over standard laparoscopic~     instruments. While the long term prognosis of prostate cancer patients who undergo radical~     prostatectomy has improved significantly over the past two decades, there remain significant~     rates of disease recurrence and complications.~      The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be~     deployed and used easily during surgery, can be registered to the robot coordinate systems~     with high accuracy, and can be controlled from the surgeon's console, in order to improve~     the visualization of the prostate and peri-prostatic anatomy, and in order to produce a~     cancer probability map that can be used to make decisions on surgical margins.~      The investigators objectives are~        1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical~          prostatectomy~        2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate~          and peri-prostatic tissue from the surgical console~      This is an observational study; trans-rectal ultrasound will be used to visualize the~     prostate and periprostatic structures during surgery but the standard of care will not be~     affected by this ultrasound imaging.~   "
80665|NCT02001584|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and~     obese (Part B), otherwise healthy subjects.~   "
80666|NCT02001571|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the~     body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s)~     with mild or moderate hepatic impairment and matched control Participants with normal~     hepatic function.~   "
80667|NCT02001558|"~     The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4~     pressure ulcers compared to sterile saline among persons with spinal cord injury.~   "
80668|NCT02001545|"~     RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study~     which will include patients hospitalized for ACS within 24 hours of symptom onset and who~     have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or~     non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the~     short-term (at the end of the first month after index event) antithrombotic management~     patterns in a real-life setting for patients hospitalized with an acute coronary syndrome.~   "
80669|NCT02001532|"~     Background~      The prevalence and incidence of type 2 diabetes is increasing globally. A common~     complication of diabetes is the disease of the blood vessels, vascular diseases, which can~     cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect~     early subclinical stages of macro-vascular disease are not yet available in a clinical~     setting.~      Hypothesis~      Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic~     information when evaluating risk profile for patients with diabetes type 2.~      Aim~      The aim of the project is to investigate the association between arterial stiffness and the~     occurrence and development of vascular complications in patients with type 2 diabetes.~     Specifically we want to investigate:~        1. in a cross-sectional study, the association between arterial stiffness and subclinical~          atherosclerotic changes in the coronary arteries assessed by computed tomography (CT)~          and~        2. in a longitudinal study, the predictive value of arterial stiffness on the development~          of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and~          nephropathy assessed by urine analysis.~      Methods~      The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100~     age- and sex matched controls. The study participants were enrolled between 2008-2011 and~     extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white~     matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we~     will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned~     measurements. Furthermore, CT is used to investigate the coronary plaque burden of the~     participants (Agatston Score and Segment Involvement Score).~      Results and Perspective~      This project adds new insight into arterial stiffness as a predictor of the progression of~     micro- and macrovascular complications in patients with type 2 diabetes, and can potentially~     improve risk stratification and early strategies of intervention in this patient group.~   "
80670|NCT02001519|"~     Achievement of pathologic complete response is important prognosticator to predict long term~     outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is~     to be investigated whether addtional pathologic complete response is achieved for those~     triple negative breast cancer patients who recieved 4 cycles of adriamycin with~     cyclophosphamide(AC4) but did not reach clinical complete response during the course of~     neoadjuvant therapy.~   "
80671|NCT02001506|"~     Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and~     sequential treatment of anthracyclines followed by taxanes, which has shown superior~     pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now.~     Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3~     cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01~     trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable~     efficacy and further reduce the duration of neoadjuvant chemotherapy.~   "
80672|NCT02001493|"~     Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell~     carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic~     agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy.~     Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that~     are useful surrogates for clinical response and also to identify patients early on who will~     benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in~     patients and also in reducing cost implications of this expensive group of drugs.~      The investigators wish to explore the variability of baseline metabolomic profile in the~     blood and urine of patients with mRCC and characterise the inter-subject and intra-subject~     variability. The study of the baseline levels has not been performed in this cohort~     previously. This is extremely important in interpreting the emerging data of changes in the~     levels of the various biomarkers from various trials. This will in turn help in the~     development of future targeted therapies, especially Phase I/II studies where an early~     demonstration of target modulation is vital. This study will also help to identify the~     number of patients required for appropriate statistical evaluation in pharmacodynamic~     studies to assess biological activity, optimisation of dosing, and investigation of~     potential mechanisms of resistance. Study of the urinary and blood metabolomic profile in~     conjunction will give us an insight into the potential use of urine as a diagnostic and~     prognostic tool.~      OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in~     metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after~     nephrectomy or antiangiogenic treatment during 2 months~   "
80673|NCT02001480|"~     Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic~     nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest~     that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk~     population. However, no results from large-scale clinical outcome trials with beta-blockers~     exist in this patient group and a broad, scientifically unapproved use of beta-blocker~     treatment may not be justified due to potential harmful side-effects such as AV-block or~     hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this~     high-risk population and on the occurrence of arrhythmias in temporary relationship to~     hemodialysis sessions.~      Therefore, the present study will identify surrogate parameters of SCD in hemodialysis~     patients with T2DM and in an interventional trial investigate the suppressive effect of~     beta-blockers on these identified ECG markers.~   "
80674|NCT02001467|"~     Simulation-based training lead to improvements in learning compared to no intervention but~     little is known of the effects on organizational improvements that are relevant to patient~     care. This study focused on the effects of training midwives in performing cervical~     ultrasound scans on continuity of care when managing pregnant women with symptoms of~     premature onset of labor. Our hypothesis is that simulation-based training can be used to~     decrease the number of shifts in primary responsible health care practitioner as midwives~     that are trained in cervical ultrasound scans may manage the patient encounter without~     engaging a second practitioner (i.e. an obstetrician).~   "
80675|NCT02001454|"~     The purpose of this study is to compare attitudes and knowledge of the staff of various~     departments in our Medical Center in regards to pain treatment. With the results of our~     survey we will then draw up a protocol on pain management.~   "
80676|NCT02001441|"~     This project will examine the relationship between physical activity levels, brain structure~     and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study~     will follow 30 adults with age-associated memory impairment or MCI over the course of 18~     months. During this time, subjects' physical activity levels will be measured regularly and~     related to both the thickness their hippocampus and to their memory performance. Subjects~     will be recruited and screened for major health problems at UCLA. Physical activity will be~     tracked for two weeks using accelerometers at baseline and every 6 months during the study.~     At baseline and at the end of the study, subjects will undergo a structural MRI brain scan~     to measure hippocampal thickness, as well as a neuropsychological evaluation to measure~     memory function. The study will seek to determine the relationship between physical activity~     level, hippocampal thickness and memory performance in older adults with age-associated~     memory impairment.~   "
80677|NCT02001428|"~     The purpose of this study is to assess the effectiveness of different malaria control~     strategies in the first year of life.~      The effectiveness of delivering an intermittent screening and treatment programme with~     dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be~     compared to the current practice of passive case detection of malaria.~      This study has two objectives:~        1. To assess the effectiveness of intermittent screening and treatment with~          dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age~          compared with the current practice of passive detection and treatment for malaria in an~          area with high drug resistance levels to both P. falciparum and P. vivax.~        2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children~          under 1 year of age.~   "
80678|NCT02001415|"~     The purpose of this study is to determine the efficacy of different lens treatments (normal~     spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.~   "
80679|NCT02001402|"~     A follow-up intervention for the climacteric symptoms of nurses in Peking~   "
80680|NCT02001389|"~     This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose-~     and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting~     phosphodiesterase 10 (PDE10)] by EVP-6308.~   "
80681|NCT02001376|"~     Background and Purpose: Fitness is the foundation for health and quality of life for~     individuals. Recent changes in lifestyle and eating habit in Taiwan have significantly~     increased the prevalence of metabolic syndrome that may lead to poor fitness and subsequent~     coronary artery disease, cardiovascular disease and diabetes. Although workers at the~     National Taiwan University Hospital (NTUH) have undertaken regular health fitness~     examination, the examination did not include the posture and movement analysis and no~     exercise intervention was provided to those with metabolic syndrome. This study is therefore~     aimed to conduct comprehensive health fitness examination for workers at NTUH and to examine~     whether exercise intervention could decrease the risk factors and enhance fitness in those~     at risk or with metabolic syndrome. Methods: This study will consist of two parts. In the~     first part, 1102 workers at NTUH will be administered comprehensive fitness examination~     (body mass index, waist circumference, muscle strength, flexibility, balance,~     cardiopulmonary test, and posture and movement analysis) and will be assessed with the~     Physical Activity Readiness and the Perceived Musculoskeletal Pain Scale and the~     International Physical Activity Questionnaire. Those workers who are at risk or have~     metabolic syndrome (N=240) will be assigned into the control, home-based exercise, and~     intensive exercise group with 80 in each group with their will. The home-based exercise~     group will receive exercise instruction biweekly for three months; the intensive exercise~     group will receive moderate aerobic exercise and strengthening exercise three times a week~     for three months. The other workers who are insufficient fitness status (N=240) will be~     assigned into the control, home-based exercise, and intensive exercise group with their~     will. The home-based exercise group will receive exercise instruction biweekly for a month;~     the intensive exercise group with 80 in each group will receive moderate aerobic exercise~     and strengthening exercise three times a week for a month. Descriptive statistics will be~     used to estimate the prevalence of 1, 2 and ≧3 metabolic risk factors, and poor fitness.~     One-way analysis of variance (ANOVA) will be used to examine the relation between metabolic~     syndrome risk factors and fitness. One-way ANOVA will be used to compare the demographic~     characteristics of the control, home-based exercise, and intensive exercise group. Two-way~     ANOVA repeated measures will be used to examine the metabolic syndrome risk factors and~     fitness in the three groups across time. Clinical relevance: Our results will help~     understand the health fitness of workers at NTUH and will assist in establishing effective~     exercise program for those at risk or with metabolic syndrome.~   "
80682|NCT02001363|"~     The investigators planned to research the cardioprotective effects of intravenous~     liraglutide on reperfusion injury.~   "
80683|NCT02001350|"~     To use carotid ultrasound to screen 20-30 patients with longstanding or resistant~     hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will~     establish a screening protocol for Cibiem's eventual endovascular carotid body modulation~     trial and will give insight into the prevalence and specific location of carotid plaque at~     the bifurcation in this patient population.~   "
80684|NCT02001337|"~     The purpose of this study is to create a prospective cohort of subjects with increased~     probability of being diagnosed with pancreatic cancer and then screen this cohort for~     pancreatic cancer~   "
80685|NCT02001324|"~     This is an observational study to determine the effect of various treatments prescribed by~     healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as~     measured by the Menstrual Bleeding Questionnaire) and to compare electronic and paper-based~     modes of data collection.~   "
80686|NCT02001311|"~     This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in~     orthodontic patient to reduce caries risk and the possible consequential effect of this use~     on the orthodontic brackets used for the treatment.~      The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in~     orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic~     brackets.~   "
80687|NCT02001298|"~     The purpose of this study is the comparison of the cardiovascular effects of remifentanil~     and nitroprusside for controlled hypotension~   "
80688|NCT02001285|"~     The purpose of this study is the comparison of the effect-site concentration of remifentanil~     for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial~     intubation during propofol-remifentanil total intravenous anesthesia.~   "
80689|NCT02001272|"~     The current standard of first-line chemotherapy in advanced ovarian cancer is the~     combination of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is~     feasible in selected elderly patients such as those included in prospective trials. These~     trials, however, include a minority of the elderly population. In wider selection of~     patients >70 years old, the standard carboplatin-paclitaxel regimen has been shown to induce~     an excess of toxicity and premature treatment stopping. For elderly patients thought to be~     vulnerable and at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel~     regimen, other options are used in routine practice. One option is to delete paclitaxel and~     treat elderly patients with carboplatin as a single agent. An alternative is to use the~     carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the~     MITO (Multicentre Italian Trial in Ovarian Cancer).~      To date, there is no randomized trial which could give us some evidence of how to select~     patients who could benefit most of one or the other regimen described above. The 4th Ovarian~     Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy~     for elderly patients with ovarian cancer and the necessity of additional research in this~     population.~      Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of~     elderly patients with advanced ovarian cancer included in a specific multicenter phase II~     trial. The best proportional hazard model fitting for overall survival identified the~     following geriatric covariates score as being poor survival risk factors: ADL score <6, IADL~     score <25, HADS score >14, albuminemia <35g/L and , lymphopenia <1G/L. GVS is the sum of~     these risk factors for each patient. Using a cut off of 3, the GVS identified a group of~     patients at high risk of severe toxicity, early cessation of treatment, unplanned~     hospitalization and adverse outcomes.~      This international multicentre randomized phase II trial will compare the success rate of~     delivering 6 courses of chemotherapy with evidence of efficacy and without premature~     termination for progression, death or unacceptable toxicity of three different chemotherapy~     regimens in a selected population of elderly patients with a GVS ≥ 3:~        -  Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks~        -  Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks~        -  Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15~          every 4 weeks)~      The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the~     first step, then 58 more by arm (total=174) after interim analysis.~   "
80690|NCT02001259|"~     The purpose of this study is to determine efficacy of epidural steroid for postoperative~     pain control after TKA~   "
80691|NCT02001246|"~     The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body~     bridging (MBB) for anger management compared with the Real Deal anger management program, in~     helping adolescents control or reduce their anger.~   "
80693|NCT02001220|"~     During weaning the work of breathing is transferred from the ventilator back to the patient.~     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of~     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to~     identify weaning candidates. Once daily screening is the current standard of care. With~     respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant~     opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the~     time spent on ventilators and in the ICU.~      The study is seeking to identify the optimal screening frequency to minimize patients'~     exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple~     construct: more frequent screening will result In earlier identification of weaning~     candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More~     frequent screening is an appealing intervention because it is sensible, low risk, and~     represents a cost effective use of current resources. This simple intervention holds promise~     as a strategy that could change clinical practice, enhance the care delivered to critically~     ill adults, and improve clinically important outcomes.~   "
80694|NCT02001207|"~     In critical illness, patients are highly stressed and should have elevated cortisol (stress~     hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical~     illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly~     responsible for its physiologic function is difficult to measure. We hypothesized that the~     salivary cortisol, which can be obtained by noninvasive methods, can more accurately~     evaluate adrenal function of critically ill patients.~   "
80695|NCT02001194|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. We will assess outcomes each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
80696|NCT02001181|"~     The study is being conducted to evaluate the efficacy, safety and tolerability of 2%~     tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic~     dermatitis compared to placebo (vehicle) BID for 4 weeks.~   "
80697|NCT02001168|"~     -  Lung cancer is one of causes of the malignant tumor-associated death on a global scale,~          in which the surgery is the only effective approach in patients with non-small cell~          lung cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC~          is 40%, while only 4%～15% patients can benefit from adjuvant chemotherapy[1]. American~          National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant~          chemotherapy can be performed on NSCLC patients in phase Ⅱ～ⅢA.~        -  In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB~          or which kind of patients would benefit from it after the establishment of new staging,~          a multi-subject group of lung cancer set up a perspective, randomized, open clinical~          trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase~          ⅠB under new staging policy, and to collect the characteristics of patients who could~          benefit from the treatment and the better adjuvant drugs after operation.~   "
80698|NCT02001155|"~     A test that was common in the 1960's and was used to detect primary open angle glaucoma was~     the water drinking test (patients drank 1 quart of water to stress the fluid drainage~     mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently~     this test has been demonstrated as a predictor of peak eye pressure during the day. The~     purpose of this study is to compare the results of the water drinking test between eyes that~     have undergone trabeculectomy and eyes that have undergone tube shunt surgery.~   "
80699|NCT02001142|"~     One of the main objectives of this study will be to assess potential differences in~     important risk factors associated with Metabolic Syndrome in overweight adults who do not~     participate in a regular exercise program compared with overweight individuals who do~     exercise regularly. In addition, we will determine the effects of a single, modest session~     of exercise on the body's ability to control blood sugar and regulate fat metabolism in~     obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study~     focuses on identifying mechanisms responsible for improved insulin action related to regular~     exercise and to provide novel targets for preventing and treating type 2 diabetes.~   "
80700|NCT02001129|"~     This study aims to examine the effectiveness of three different ways of helping patients~     attend their recommended eye care appointments.~   "
80701|NCT02001116|"~     A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO~     was established, for the implementation of a WHO Project to improve the quality of pediatric~     care in the referral hospitals. The pilot regions selected for this intervention are the~     three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH~     project will be implemented at a first stage in a group of 10 pilot hospitals, randomly~     selected among the existing hospitals in the above cited regions. Pilot Hospitals will be~     compared to control hospitals, which are the hospitals in the region not receiving the~     intervention, using a pre-defined set of indicators of quality of care. The results of the~     present evaluation on the pilot hospitals will provide data that will inform the MOH on how~     better to scale up this project at a national scale.~   "
80728|NCT02000765|"~     This is an open-label, non-randomized, two-period, cross-over, mass balance study that will~     evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of~     [14C]-GSK2140944 (Period 1) and a single oral dose of [14C]-GSK2140944 ( Period 2) in 6~     healthy male subjects. The results from this study will aid in the design of future clinical~     pharmacology studies such as the thorough corrected QT interval study, special population~     studies (renal, hepatic, critically ill patients), potential drug interaction studies, and~     will help to establish safe and efficacious intravenous and oral dosing regimens.~   "
80841|NCT01999296|"~     All patients undergoing laparoscopic visceral and gynecologic procedures using the combined~     bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a~     prospective registry. Data will be analysed concerning the safe use of the instrument and~     perioperative blood loss.~   "
80702|NCT02001103|"~     The specific aim of this project is to test if memantine add-on therapy will be helpful for~     patients with first episode schizophrenia who present with or without cognitive impairments~     and negative symptoms, to examine the efficacy and safety of memantine as an adjuvant agent~     to their ongoing maintenance therapy with atypical antipsychotics. Our objectives include:~        1. Test memantine add-on by 2 different dosages comparing to a placebo-controlled group of~          clinically stable first episode schizophrenic patients who are under second-generation~          antipsychotic maintenance therapy. The results will give us information regarding~          effective dosage and the profile of adverse drug reactions while using on this~          population.~        2. Examine whether the effect of memantine add-on will be affected by any significant~          baseline clinical variables or predisposed cognitive deficits. That is to say, if~          memantine will only demonstrate adjunctive effect on those who are cognitively impaired~          or its effect is independent from baseline cognitive functioning or the severity of~          baseline psychopathology.~        3. Examine the changes in negative symptoms as the secondary outcomes to see if such a~          cognitive enhancing effect to be concurrent with an improvement in negative symptoms or~          independent from changes in negative symptoms.~        4. Treat the changes in positive symptoms and other clinical outcomes, such as~          readmission, being employed/going back to school, and psycho-social functioning scores~          as the tertiary outcomes to examine the effectiveness of memantine add-on.~   "
80703|NCT02001090|"~     This study examines the flow mediated dilation (FMD) of the brachial artery before and after~     cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved~     trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is~     measured before surgery and on the first morning after the operation.~   "
80704|NCT02001077|"~     This is a single-center, randomized controlled trial study design. Enrolled participants had~     comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral~     intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The~     study intervention period lasted eight weeks. The objective of the study is to examine the~     impact of two behavioral treatments on sleep and pain and to better understand what causes~     chronic pain and chronic sleep disturbance.~   "
80705|NCT02001064|"~     Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of~     therapeutic results, the benefit of ART increases as adherence improves. Consequences of~     suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and~     more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous~     co-occurring conditions and therefore take many medications making adherence to multiple~     drug regimens more difficult. A mobile application capable of improving medication adherence~     among HIV-infected persons would be highly useful.~      The investigators propose an intervention study designed to address these potential~     mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app).~     The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart~     phone application titled Care4Today v2.0 versus standard of care to improve medication~     adherence to ART over a 4-week period with 60 HIV+ participants.~      The pilot RCT consists of 60 HIV+ persons who are at risk for ART medication nonadherence.~     Using random assignment, 30 HIV+ participants will be assigned to medication adherence~     improvement via Care4Today app as compared to 30 HIV+ participants assigned standard of~     care.~      The investigators will assess the effectiveness and acceptability of the app in improving~     objectively measured ART adherence (i.e., via medication event monitoring system caps) over~     a 4-week period via a pilot RCT with 30 HIV+ persons assigned to the Care4Today intervention~     and 30 HIV+ persons assigned to standard of care.~   "
80706|NCT02001051|"~     Background:~      - Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the~     body, which can lead to diabetes, obesity, and other diseases. Some people with extra~     cortisol will show symptoms like bruising and muscle weakness. Others will show no signs.~     This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant.~     Researchers want to know the best way to treat people with subclinical hypercortisolism.~     They want to know if removing the tumor by surgery reduces the long-term effects of the~     disease.~      Objectives:~      - To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity,~     osteoporosis, or cholesterol, and cancer detection.~      Eligibility:~      - Adults 18 and older with an adrenal tumor and high cortisol levels.~      Design:~        -  Participants will be screened with medical history, blood tests, and a CT scan.~        -  Participants will have a baseline visit. They will have blood and urine tests and 7~          scans. For most scans, a substance is injected through a tube in the arm. Participants~          will lie still on a table in a machine that takes images.~        -  Participants will have surgery to remove their tumor. Some will have surgery right~          away. Some will have surgery 6 months later, after 2 follow-up appointments.~        -  Participants will have 4 follow-up visits in the first year after surgery. They will~          have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit,~          they will have scans and blood tests.~   "
80707|NCT02001038|"~     Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot~     deformities are frequent complications in CMT patients and orthopaedic surgery is often~     required. As yet there are no systematic studies on the management of orthopaedic~     complications in CMT patients and the current approach varies between centres. This study is~     a survey with the aim of understanding the current surgical approach to orthopaedic~     complications in CMT.~      The target population includes orthopaedic surgeons who perform surgical procedures for foot~     deformities in CMT patients attending centres participating in the Inherited Neuropathies~     Consortium (INC).~   "
80708|NCT02001025|"~     The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has~     a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating~     pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared.~     This study assesses the incidence of malapposed stent-struts, and the frequency of~     stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE~     stent.~   "
80739|NCT02000622|"~     This open label, randomised, controlled, multi-centre phase III study will assess the~     efficacy and safety of single agent olaparib vs standard of care based on physician's choice~     of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2~     mutations.~   "
80709|NCT02001012|"~     Preliminary studies have supported the background efficacy of local standard anti-malarial~     medications in the treatment of uncomplicated knowlesi malaria, however there are no current~     WHO treatment guidelines for this infection. There are both health cost benefits to a more~     rapidly acting agent, and due to difficulties with microscopic identification there may be~     more effective treatment for all malaria species if an aligned treatment guideline could be~     supported. We are currently conducting a separate RCT using a similar protocol evaluating~     artesunate-mefloquine versus chloroquine for uncomplicated P. knowlesi malaria. However~     artemether-lumefantrine should also be compared against chloroquine due to the fact it is~     also a first line anti-malarial recommended in Malaysia, and there are potential differences~     in efficacy due to the different administration, absorption and half-life of~     artemether-lumefantrine.~      The investigators aim to test whether the fixed combination of artesunate-mefloquine is~     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.~     knowlesi infection in both adults and children in this region.~   "
80710|NCT02000999|"~     The purpose of this prospective study is to compare the diagnostic utility of two techniques~     (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary~     strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging~     follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this~     the investigators will ask study participants to have a small volume of fluid obtained from~     the bile duct sent for additional testing at RedPATH. In some patients additional brushings~     will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is~     increased procedure duration).~      The investigators hypothesize that the use of cytology +DNA analysis has a higher~     sensitivity and accuracy when compared to cytology +FISH in patients with biliary~     strictures.~      Primary aim:~      To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and~     brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology~     for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve~     as the gold standard for diagnosis of malignancy.~      Secondary aims:~        1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology,~          FISH and DNA analysis) are used.~        2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with~          cytology, FISH and DNA analysis.~   "
80711|NCT02000986|"~     This clinical trial studies dietary and exercise interventions in preventing cardiovascular~     disease in younger survivors of childhood cancer. Eating a healthy diet and exercising~     regularly may reduce the risk of cardiovascular disease in younger survivors of childhood~     cancer.~   "
80712|NCT02000973|"~     The investigators designed a prospective, randomized, placebo-controlled study to determine~     whether thoracic epidural anesthesia(TEA) with different local anesthetics has different~     influences on the propofol dose during induction.~   "
80713|NCT02000960|"~     Glucose transporter deficiency syndrome (Glut1-DS) is a form of pediatric epilepsy caused by~     a genetic mutation that disrupts the body's ability to process food from the child's diet~     into sugar (energy) needed to support brain function. Children with Glut1-DS experience~     seizures that are not controlled by anticonvulsant medications, as well as delays in~     cognitive and motor development. Currently, Glut1-DS is treated with the ketogenic diet, a~     high-fat, low-sugar diet that provides the brain with an alternate source of energy. Despite~     the significant improvement of seizures upon this diet, seizure control is incomplete in a~     majority of children, and they continue to experience problems with brain development. Our~     team of researchers and clinicians with expertise in metabolic diseases, neurology,~     pediatrics, biochemistry, and genetics believes that there is an opportunity to achieve~     CURE's goal of No Seizures/No Side Effects for children with Glut1-DS by investigating the~     use of a new treatment option that is designed to compensate for the underlying biochemical~     deficiency thought to contribute both to the seizures and to the impaired brain development~     associated with Glut1-DS. The proposed treatment involves incorporating a special type of~     oil, called triheptanoin, into the ketogenic diet as a way to make up for a specific~     biochemical deficit affecting kids with Glut1-DS that the standard ketogenic diet fails to~     address. Our goal is to do a pilot study to test the safety and effectiveness of this~     promising new treatment option in a small group of children with Glut1-DS.~   "
80714|NCT02000947|"~     The purpose of this study is to determine if MEDI4736 will be adequately tolerated in~     combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).~   "
80715|NCT02000934|"~     This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult~     patients with advanced solid tumor and lymphoma malignancies. This study will be the first~     to administer TAK-659 to humans. The patient population during dose escalation (Part A) will~     consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which~     standard, curative, or life-prolonging treatment does not exist or is no longer effective.~     This first-in-human (FIH) study will include 5 dose expansion cohorts in refractory and/or~     relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), indolent~     Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant Lymphoproliferative~     Disorder (PTLD) (Part B) following completion of dose escalation (Part A).~   "
80716|NCT02000921|"~     The main focus of this study is to determine the use of nicotine-containing products across~     the three experimental conditions. Subjects will be monitored to determine their continued~     use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or~     cessation of all tobacco containing products.~   "
80717|NCT02000908|"~     This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of~     photobiomodulation therapy using the Realief Therapy system. The patients will be randomized~     in a 3:4 ratio to treatment or sham arms.~   "
80740|NCT02000609|"~     The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary~     variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol~     administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.~   "
80741|NCT02000596|"~     This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in~     women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally~     advanced and/or metastatic breast carcinoma.~   "
94911|NCT01814800|"~     This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous~     infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary~     Immunodeficiency Diseases (PIDD).~   "
80718|NCT02000895|"~     Infants born preterm and of low birth weight are known to be at increased risk for early~     onset of cardiovascular and renal disease in adult life. This has been related to low~     nephron mass due to inadequate or early termination of glomerulogenesis in utero and during~     the perinatal period. Risks for subsequent development of hypertension and kidney disease~     include proteinuria, excessive weight gain during early life with insulin resistance and~     supplemental high calorie feedings. The long-term goal is for early diagnosis of those~     infants who are at risk for future development of hypertension and kidney disease so that~     the investigators might intervene to potentially avert progression to adult disease. The~     objective of this clinical trial is to acquire data on the natural history of neonatal~     kidney function and size in infants born preterm during the first 2 years of life. This will~     be done through the use of standard serum and urine markers as well as non-invasive~     ultrasound technology. The central hypothesis of this clinical trial is that a subgroup of~     patients born preterm and of low birth weight will demonstrate early markers of kidney~     injury including elevated serum cystatin C, proteinuria and low kidney size. This hypothesis~     has been formulated on the basis of preliminary data from our group studying this question~     retrospectively in older children born prematurely who have developed overt kidney disease.~     The rationale for the proposed research is to develop early serum and demographic markers of~     pre-clinical kidney disease so that early intervention can occur. The proposed clinical~     trial is innovative because it will investigate the risk factors for kidney dysfunction at a~     pre-clinical stage with the idea of gaining more knowledge regarding therapeutic~     interventions. In addition, the study will assess serum cystatin C as a surrogate test for~     glomerular filtration rate which could indicate worsening kidney function at an earlier~     stage than serum creatinine.~      The proposed research is significant because it is expected to identify at-risk patients for~     future renal impairment and to prospectively monitor the persistence of proteinuria and its~     effect on kidney function in the short term.~   "
80719|NCT02000882|"~     This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in~     breast cancer patients with brain metastases.~      Both capecitabine and BMK120 have previously shown activity in patients with breast cancer.~     Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a~     preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).~   "
80720|NCT02000869|"~     People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this~     increased risk is complex but there is strong evidence that changes in arterial stiffness~     play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and~     augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is~     signiﬁcantly associated with the future risk of clinical events. In addition, aPWV is an~     independent and powerful predictor of all-cause and cardiovascular mortality in patients on~     dialysis. Reduction of aPWV, mainly by use of an ACE-inhibitor results in an improved~     survival in dialysis patients. These findings suggest that arterial stiffness is not merely~     a marker of arterial damage but a potentially reversible factor contributing to mortality in~     dialysis patients. There is strong evidence that arterial stiffness increases as glomerular~     filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a~     number of studies as a significant risk factor for CKD progression.~      In addition to arterial stiffness, elevated central aortic blood pressure and central pulse~     pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood~     pressure is more strongly related than standard BP measured at the brachial arteries~     (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery~     hypertrophy as well as to future cardiovascular events.~      Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although,~     successful kidney transplant has been shown to improve arterial stiffness post-transplant,~     we do not know to what extent the pre-transplant arterial stiffness and central aortic blood~     pressure and their improvement post-transplant impact the cardiovascular and allograft~     outcomes. In addition, it is unclear what transplant related factors are associated with~     improvement in arterial stiffness and central aortic blood pressure post-transplant.~      The goals of our study are:~        1. To determine if pre-transplant central blood pressure and aortic stiffness impact~          post-transplant cardiovascular and kidney allograft outcomes.~        2. To determine whether the changes in central blood pressure and aortic stiffness~          post-transplant impact cardiovascular and kidney allograft outcomes.~        3. To determine the factors associated with improved central aortic blood pressure and~          arterial stiffness post-transplant.~   "
80721|NCT02000856|"~     The study is a single center randomised, double-blind, placebo-controlled crossover study to~     assess the effects of beetroot juice in patients with pulmonary arterial hypertension.~   "
80722|NCT02000843|"~     Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to~     repair broken eardrums. The Heermann approach is a well recognized procedure, in common~     clinical practise for years.~      The new approach has been used in patients after informed consent was obtained from each~     patient.~   "
80723|NCT02000830|"~     The objectives of this follow up study are to evaluate the long-term effects of~     stannsoporfin (Stanate) on the health, growth, and development of patients who received a~     single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients~     in the control (placebo plus PT) group in clinical trial 64,185-204.~   "
80724|NCT02000817|"~     The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of~     intravenously administered otelixizumab. In addition, the C-peptide decline in new onset~     type 1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be~     investigated with a view to identifying trends and early immunological biomarkers which~     could predict response in halting/slowing Beta-cell destruction in this patient population.~      This exploratory study will explore the safety and tolerability between the well tolerated~     but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which~     efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr~     Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the~     tolerability dose response is considered a necessary first step to determining the~     therapeutic index of otelixizumab.~   "
80725|NCT02000804|"~     This study is to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and safety of 160 mg~     enteric-coated micronised free base darapladib in healthy Chinese subjects.~   "
80726|NCT02000791|"~     it is compared that laryngeal mask insertion with standard technique and laryngoscopic~     technique~   "
80727|NCT02000778|"~     The overall prevalence of Ovarian Cancer in the United States according to the US SEER~     Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the~     gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV~     it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less~     than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age~     and decreases with numbers of pregnancies.~      The prognosis for many carcinomas is dependent on the extent of surgical resection. At~     present, the ability to perform a complete resection with negative margins is limited by the~     investigator's ability to palpate and visualize the tumor and its borders. In many cases, a~     more radical resection than necessary is performed in order to provide assurance that~     negative margins are achieved. This approach may also increase complication rates, as well~     as short- and long-term morbidity. It is desirable to improve visualization of primary~     tumors and occult metastases in real time, during surgery. The use of fluorescent probes~     that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is~     under investigation.~      Ovarian cancer is a prototypic disease for this type of clinical imaging system called~     intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or~     abdomen and typically involve extensions or implants onto pelvic or abdominal organs or~     membranes. Tumor debulking surgery is common early in the disease process as many of the~     tumors can be identified by appearance or feel in the skilled surgeon's hands. The major~     problems are that tumors can be diffuse and numerous, of various sizes, and often not~     readily visible in the surgical field.~      Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this~     receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist~     at the FR-alpha with potential uses for imaging and targeted therapeutic~     strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens~     examined by immunohistochemistry, so prior treatment is unlikely to affect utility of~     FR-alpha agonists as imaging or therapeutic agents.~   "
80742|NCT02000583|"~     The purpose of this study is to learn about the possible benefits of aerobic exercise in~     controlling or reducing the amount of amyloid present in the brain, reducing changes in~     brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability~     in individuals that have amyloid deposits and are at risk to develop AD.~   "
80729|NCT02000752|"~     In this study, a single blind randomized trial is carried out in order to compare placental~     detachment times when Ren Mai 6 is stimulated and when a different placebo point is used.~     So, a lower detachment time is assumed to be related to a higher uterine contraction, and,~     therefore, a decrease in the hemorrhage postpartum. We focus on measuring the time it takes~     to placental delivery due to the fact that, if this point promotes the uterine contraction,~     then the placental delivery will be produced in a short time. Thus, this technique could~     decrease the hemorrhage postpartum.~      The principal outcome of the study is the placental expulsion time. This time is measured by~     the midwife who is responsible of the birth, and it considers the time passed between the~     delivery of the newborn and the complete expulsion of the placenta.~      Concerning the secondary outcomes, the application of real acupuncture in Ren Mai 6 point,~     and sham acupuncture in the placebo point are considered. Their study is derived from the~     statistical analysis of the results of the principal outcome. The existence of pain related~     to the treatment and the degree of satisfaction of the mother is also a secondary outcome,~     analyzed by the survey that the midwife carries out no more than 2 hours after the labor. At~     last, it is important to highlight that the degree of satisfaction of the midwife is also~     considered as a secondary outcome, since it is registered in the same survey.~   "
80730|NCT02000739|"~     Genetic mutations associated with cancer are being discovered and new treatments are being~     created to treat people whose cancer tumors have certain genetic mutations. Genetic~     sequencing of a tumor can be done, and in this study that information is sent to a company~     called N-of-One. They will match each patient's tumor's genetic profile to targeted~     therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of~     FDA-approved drugs, or use of experimental drugs in clinical research studies open at~     various locations in the region.~      The purpose of the study is to compare the length of time it takes for a tumor to grow in~     people who receive the standard treatment for metastatic cancer to the length of time it~     takes for a tumor to grow in people who receive a drug specifically targeted for their~     cancer's genetic mutation.~      Investigators will do a kind of genetic testing called DNA sequencing. Everyone who takes~     part in this trial will have genetic testing done on their cancer tumor tissue here at~     Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.~      The treatment participants get will depend on the results of the DNA sequencing and the~     availability of targeted therapies that match the genetic profile of the tumor identified by~     the DNA sequencing.~      If there is no genetic mutation that can be identified with current DNA sequencing,~     participants will receive the standard treatment for metastatic cancer.~      If there is a genetic mutation that can be identified with current DNA sequencing and a drug~     has been developed for this mutation, participants may be able to receive that drug. If~     there is more than one drug available, the participant and his/her oncologist will decide~     which is the best one for the participant.~      Because there are many drugs that may be used in this study, the investigator cannot advise~     in advance whether or not the drug a participant might receive has been approved by the U.S.~     Food and Drug Administration (FDA).~   "
80731|NCT02000726|"~     Current medical therapies for depression take weeks to achieve full efficacy, and are~     ineffective in many patients or cause intolerable side effects, emphasizing the need for a~     deeper understanding of depression and its treatment. Identifying early brain biomarkers of~     treatments responses seems necessary to improve antidepressant treatment outcome. In this~     study we aim to detect early brain responses to a fast acting antidepressant-like treatment~     administered intravenously during a Real-Time Neurofeedback functional magnetic resonance~     imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion~     of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a~     selective serotonin reuptake inhibitor (SSRI).~   "
80732|NCT02000713|"~     The investigators are wanting to know if magnetic resonance imaging can accurately provide~     an early diagnosis of amyotrophic lateral sclerosis (ALS).~   "
80733|NCT02000700|"~     The purpose of this study is to evaluate the pharmacokinetics (blood levels) and~     pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children~     and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other~     purposes are to investigate safety and assess the ease of swallowing the tablets.~   "
80734|NCT02000687|"~     This is a single-center, prospective, open label study in islet transplant recipients~     following islet graft loss.~   "
80735|NCT02000674|"~     All adult patients with spontaneous cardiac activity and requiring tracheal intubation in~     the pre hospital emergency context will be included in order to compare the use of~     succinylcholine vs Rocuronium for prehospital emergency intubation.~   "
80736|NCT02000661|"~     Fractional flow reserve (FFR) is a test that can be performed at the time of heart~     catheterization. It measures the change in pressure across a narrowing in the heart artery~     during high flow situation, and provides reliable information about the functional severity~     of the narrowing. FFR measurements accurately predict whether a stent is needed, and is~     considered an excellent test before placement of stents to treat narrowed heart arteries.~     However, FFR is not used in every case because of the extra time needed and the associated~     device costs. Cardiac Services BC (an agency of Provincial Health Services Authority) is~     sponsoring this study to find out if FFR should be used in most cases (routine), rather than~     the current selective approach.~   "
80737|NCT02000648|"~     Observation study of patients with chronic rhinitis or chronic urticaria in Thailand~   "
80738|NCT02000635|"~     The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011~     was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence~     (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated~     with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide~     range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are~     described as meningitis, uveitis and classical severe presentation such as lung bleedings~     and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of~     the disease.~      Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic~     confirmation during the first week of development and before the appearance of the first~     antibody.~      If the microagglutination test (MAT) is considered the gold standard test for diagnosis of~     leptospirosis. However it requires rending samples to the referent National center for the~     leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the~     second week of illness. A second sample is required 15 days after the first one, to confirm~     the diagnosis.~      In clinical practice , the technique of real-time PCR for the detection and quantification~     of pathogenic Leptospira during the first week of illness . The technique of diagnosis of~     leptospirosis by real-time PCR has been implemented and tested in 2007 at the University~     Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of~     antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days,~     regardless of the severity of the disease. The evolution of leptospiremia treated patients~     has not been studied to date.~   "
87753|NCT01908725|"~     The overall objective of this trial is to provide aftercare treatment with Lamazym and to~     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis~     whom previously participated in Lamazym-trial.~   "
80743|NCT02000570|"~     Intraoperative optimization of cardiac output using goal directed fluid challenge is~     associated with better outcome. Dynamic preload dependence indicators are well validated~     during surgery in supine position. Positioning from supine to sitting position under~     anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values~     of dynamic preload dependence indicators during surgery in sitting position are unknown. The~     objective of this prospective study is to evaluate ability of three dynamic preload~     dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation)~     and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.~   "
80744|NCT02000557|"~     The present day social setup considers facial charisma as an important physical~     characteristic. The facial characteristics of an individual are measured through~     anthropometry, photogrammetry, computer imaging and cephalometric radiographs. Cephalometric~     radiographs offer significant diagnostic information regarding the association between the~     dental and skeletal structures. By means of photogrammetric measurements, a fresh diagnostic~     resource is accessible to the orthodontist which permits an intangible, radiation free~     attainment of measure points of soft tissue with no instrumental expense and radiation to~     the patient.~      Orthodontic patients range from adolescents to senior citizens and originate from an~     assortment of populations, thus an extensive series of representative norms will be ideal.~     Knowledge of the normal dentofacial outline of every group will make certain better success~     of treatment to set up the best possible facial agreement. Hence, it is extremely important~     to assess the soft tissue profile of a patient as it is one of the most vital components of~     orthodontic diagnosis and treatment planning.~      The purpose of the present study is to evaluate the photographic characteristics of soft~     tissue facial profile of patients with class II malocclusion as ethnic differences have been~     found to be reported in the literature. It is hypothesized that soft tissue facial~     characteristics on lateral profile photographs and lateral cephalometric radiographs in a~     sample of local population with class II malocclusion are closely related.~   "
80745|NCT02000544|"~     The purpose of this clinical research study is the design of a novel modular hybrid system~     extracorporeal circulation circuit for open heart procedures that could easily be converted~     from a closed to a semi-closed circuit according to the indication. This could expand the~     potential of minimal extracorporeal circulation and could ultimately become the new standard~     circuit in performing every type of cardiac surgery.~   "
80746|NCT02000531|"~     This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin~     combination chemotherapy as the first-line treatment for patients with non-small-cell lung~     cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.~      This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as~     a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients~     previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease~     progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will~     be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles~     until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).~   "
80747|NCT02000518|"~     Acute neurological deficit in metastatic spinal cord compression is an emergency condition~     in radiation oncology. Despite some reports about the high efficacy of radiation treatment~     for oncological emergencies, a standard of care is not well defined, especially the time~     interval of immediate RT after deficit, and neurological outcome with respect to poor~     survival in non-small cell lung cancer patients. The objective of this trial is to~     investigate neurological outcome after emergency radiotherapy in metastatic spinal cord~     compression of non-small cell lung cancer patients with acute neurological deficit.~   "
80748|NCT02000505|"~     Comparison of various methods to improve the quality of CPR~   "
80749|NCT02000492|"~     Inactivity among schoolchildren is a challenge to public health and for the municipality in~     particular. This study´s aim is to evaluate the cognitive and physical as well as social and~     fitness adaptations, and learning outcomes of short- and long term ball training for 9-11~     years old girls and boys, and to determine to what extend the organisation (5x12 minutes og~     3x40 minute a week) and type of training (ball games, circuit training or running) influence~     the magnitude of response.~   "
80750|NCT02000479|"~     The purpose of this study is to investigate the effects of a combined training programme on~     insulin resistance, exercise tolerance, muscle strength, body composition and cardiac~     function in chronic heart failure patients.~      It is assumed that the above mentioned clinical parameters will improve due to physical~     exercise.~   "
80751|NCT02000466|"~     The purpose of this pregnancy registry study is to detect and describe any abnormal~     pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval~     Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies~     by patients and health care providers (HCPs). Data such as vaccination with FluLaval~     Quadrivalent during pregnancy or within 28 days preceding conception, potential confounding~     factors (such as exposure to other medications) and information related to the outcome of~     the pregnancy will be collected prospectively.~   "
80752|NCT02000453|"~     This is an open label exploratory study to investigate the safety of 400 milligram (mg )~     twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative~     colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up~     to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6~     out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week~     2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows~     for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the~     safety and tolerability of GSK2586184. The primary endpoints to measure safety are~     laboratory tests (including haematology, clinical chemistry and serum creatinine), vital~     signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting.~     These are standard measurements to evaluate safety.~   "
80753|NCT02000440|"~     This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate~     the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21~     subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive~     proteinuria as indicated by a Urinary protein/creatinine Up/c ratio >=2 gram/gram (g/g) or~     24 hr urine protein >=2 g/day. Losmapimod will be orally administered twice daily over a~     24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments.~   "
80754|NCT02000427|"~     This study seeks adult subjects with R/R Ph+ B-precursor ALL. This is a single-arm Simon II~     stage design, multicenter study consisting of a screening period, an induction treatment~     period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional~     cycles of blinatumomab for applicable subjects), and a safety follow-up visit 30 days after~     treatment. Following the safety follow-up visit, subjects will be followed for response~     duration and survival every 3 months for 18 months or death, whichever occurs first.~   "
80755|NCT02000414|"~     Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In~     France, It contributes to the technique failure, responsible for about 20% of cases of~     transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to~     studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.~      Based on the recommendations of the International Society for Peritoneal Dialysis, the~     intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics~     (intravenous and intraperitoneal) was studied and protocols for IP administration were~     validated.~      Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is~     presented as an alternative to vancomycin in infections resistant pathogens. The stability~     of daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial~     activity as well.~      Seven patients were treated with daptomycin intraperitoneally successfully. But no study has~     reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study~     of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive~     peritoneal infection.~   "
80756|NCT02000401|"~     Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool~     for Interstitial Cystitis without the risk and undesirable effects of narcotics.~   "
80757|NCT02000388|"~     To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine~     (SPRIX) as an option for pain management in post vasectomy patients.~   "
80758|NCT02000375|"~     A phase II non randomized study evaluating the role of Androgen Receptors as Targets for~     therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or~     PgR-positive/AR-positive metastatic breast cancer.~      Study Design: Multicentric, Open-label not randomized trial.~      Description of Study Treatment:~      Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in~     combination with a daily oral administration of anastrozole at dosage of 1 mg/die or~     letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without~     interruption until discontinuation for progression of disease, unacceptable toxicity or~     discontinuation/withdrawal of participants from study treatment.~      Number of Subjects:~      12 patients per group in the first step; if the number of responders is greater or equal to~     2, recruitment will continue up to a total of 35 patients (per group).~      For the biological part, we will evaluate:~        1. Correlation between AR expression and clinical and biological features (tumor size,~          nodal status, histotype, grading, proliferative index, ER, PgR, HER2)~        2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct~          populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or~          PgR-positive/AR-positive~        3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is~          possible) and comparison with the same features of primitive tumor.~        4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and~          functionality (vitality and tumorigenicity).~        5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline~          before study treatment and at the moment of discontinuation of treatment.~   "
80759|NCT02000362|"~     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with~     moderately active Crohn's disease after injection for 28days.~      The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of~     FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)<150 after injection.~   "
80760|NCT02000349|"~     The investigators propose to perform a clinical randomized trial to evaluate the effect of a~     frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation~     rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next~     Generation Sequencing (NGS).~   "
80761|NCT02000336|"~     Although cortisone is widely used in the treatment of patients with early rheumatoid~     arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon~     starting dosages and placebo in the treatment of patients with early active rheumatoid~     arthritis on the background of the established therapy with methotrexate. In total 450~     patients will be included into the study. Two different treatment arms starting with 10 or~     60 mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In~     parallel, all patients start medication with methotrexate, usual dosage 15 mg/week. Primary~     efficacy endpoint is progression of radiographic damage after one year compared to baseline.~     Safety monitoring is performed.~   "
80762|NCT02000323|"~     to compare different time points for enteral nutrition in SAP patients~   "
80763|NCT02000310|"~     The lysosome is a specialized part of the cell that functions to degrade metabolic wastes in~     the cell. Defects in the functioning of the lysosome result in accumulation and subsequent~     storage of such metabolic wastes. These defects lead to conditions known as lysosomal~     storage diseases (LSD). LSDs are caused by inherited genetic mutations and there are over 40~     genetically distinct lysosomal storage diseases. Within each specific lysosomal storage~     disease there are variances in severity of disease, age of onset, and clinical presentation.~     Though the genetic mutations contributing to the disease have been largely clarified, the~     molecular and cellular mechanisms that contribute to variations in each distinct LSD remain~     unclear. With this study we intend to better understand at the cellular and molecular level~     how the accumulation and storage of metabolic wastes in the lysosome affect the clinical~     manifestation of LSDs, to detect changes in these mechanisms upon treatment administration,~     and to correlate these results to genetic information. The knowledge obtained from this~     research study could lead to better ways to diagnose and treat lysosomal storage diseases.~   "
80764|NCT02000297|"~     This study is conducted to determine whether a new synthetic bone substitute is better than~     allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy~     in terms of postoperative pain, postoperative bleeding, operation time and bone healing. The~     investigators hypothesized the new synthetic bone substitute would bring better outcomes in~     the outcome variables mentioned above.~   "
80765|NCT02000284|"~     Researchers at Arkansas Children's Hospital Research Institute are conducting a study about~     mitochondrial function in children. The study involves 2 visits to Arkansas Children's~     Hospital with fasting blood draws and behavioral assessments.~      ENROLLMENT IS LIMITED AT THIS TIME TO MITOCHONDRIAL DISEASE AND TYPICALLY DEVELOPING~     POPULATIONS~      Patients may be eligible to participate if he or she is between the ages of 0‐17 years~      And falls into one of the following groups:~        -  Is Typically Developing with no known problems OR~        -  Has a history of Developmental Delay OR~        -  Has been diagnosed with an Autism Spectrum Disorder OR~        -  Has a history of a Mitochondrial Disease.~      There is no cost for visits or study‐related exams. Participants will receive gift cards as~     compensation for their time.~      For further information, please contact the program manager, John Slattery, at~     jcslattery@uams.edu or 501-364-3556~   "
80766|NCT02000271|"~     Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little~     data to support the practice, purported benefits include reduced pelvic fluid accumulation~     or blood loss. Patients often complain of discomfort associated with the packing or its~     removal.~      This randomized controlled trial seeks to document differences in subjective impressions of~     pain in women undergoing vaginal repairs treated with and without packing. The investigators~     also aim to assess differences in postoperative fluid collection in those with and without~     packing.~   "
80767|NCT02000258|"~     Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate~     ligament (ACL) reconstruction were associated with each other so that MRI-based graft~     invisibility in the anteromedial (AM) graft would have an impact on anteroposterior~     stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational~     stability of the knee.~      Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB)~     ACL reconstructions. Two independent examiners made the clinical examinations at the~     two-year follow-up: clinical examination of the knee, KT-1000, International Knee~     Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score.~     The MRI evaluations were made by two musculoskeletal radiologists separately and the means~     of these measurements were used.~   "
80768|NCT02000245|"~     The purpose of this study is to evaluate the effect of verbal expression of sympathy and~     touch on anxiety of patients undergoing fiberoptic bronchoscopy~   "
80769|NCT02000232|"~     Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical~     settings.~      Our study will assess the impact of this Initiative on colchicine use and will provide data~     that supports its continuation and expansion.~   "
80770|NCT02000219|"~     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering~     plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.~   "
80771|NCT02000206|"~     A prospective, randomized, patient-blinded comparison of the safety and efficacy of~     conscious sedation by propofol/alfentanil with propofol/ketamine in patients undergoing~     flexible fiberoptic bronchoscopy.~   "
80772|NCT02000193|"~     This is a prospective, single arm phase II study to evaluate the efficacy and safety of~     fulvestrant as a maintenance hormone therapy after first-line chemotherapy for~     postmenopausal HR positive advanced breast cancer.~   "
80773|NCT02000180|"~     It is hypothesized that a progressive simulated learning strategy will result in better~     global clinical performance (e.g., technical, communication) and transfer of endoscopic~     skill, as compared with a high-fidelity simulation strategy.~   "
80774|NCT02000167|"~     The purpose of this study is to determine whether a relationship exists between gene~     deletion(s) specific to the mitochondrial electron transport chain and presentation of~     clinical characteristics in patients with Phelan-McDermid Syndrome (PMS).~   "
80775|NCT02000154|"~     This is an extension study study to investigate long term safety of SyB L-1101 when~     administered intravenously every 4 weeks to the patients who have completed 8 cycles in the~     study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered~     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome.~     Antitumor effects will also be investigated in this study.~   "
80776|NCT02000141|"~     To enhance understanding of the risk factors for AMN, improve lesion assessment and~     prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce~     complications of WF-EMR and improve the understanding of the progression of large lesions to~     cancer~   "
80777|NCT02000128|"~     1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid~          management versus experiential way on clinical outcome in peritoneal dialysis patients.~        2. Design: prospective,randomized,controlled,single center study~        3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is~          associated with increasing hazard of death and cardiovascular events. Bioimpedance~          analysis is a safe, and easy way, which appears to be more useful and sensitive than~          other techniques for assessing volume status in dialysis patients. Therefore we~          hypothesize that more concise and strict fluid management guided by BIA may help to~          improve patients' survival, decrease cardiovascular events and hospitalization rate.~        4. Objects: incident and prevalent patients with overhydration status.~             1. anticipated cases:240~             2. arms: all the patients are randomized into two arms.(BIA group/clinical group)~             3. observational time:12 months~        5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival,~          cardiovascular events, peritonitis, residual renal function.~   "
80778|NCT02000115|"~     The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical~     study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter~     Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery~     methods.~   "
80779|NCT02000102|"~     Patients with diabetic macular edema who were switched to aflibercept after having been~     treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual~     acuity and anatomic outcomes.~   "
80780|NCT02000089|"~     Johns Hopkins clinical research office quality assurance group will monitor and audit this~     study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal~     monitoring at their site.~   "
80781|NCT02000076|"~     The main purpose of this study is to investigate the effects of partial sleep deprivation~     (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional~     regulation.~   "
80783|NCT02000050|"~     Phase II study of up-front chemotherapy and neo-adjuvant shortcourse radiotherapy for~     resectable rectal carcinoma.~      Study Design: Phase II, open-label, single-arm, multi-centre study.~      STUDY PRODUCT,DOSE,ROUTE,REGIMEN AND DURATION OF ADMINISTRATION:~        1. Neoadjuvant Treatment (pre-operative chemo-radiotherapy regimen):~           FOLFOX4* 2 cycles (WK1+WK3) - Tomotherapy** (WK5) - FOLFOX4* 2 cycles (WK7+WK9)~           * Oxaliplatin 85 mg/m2 iv: day 1 Levofolinate 100 mg/m2 iv: day 1-2 5-fluorouracil 400~          mg/m2 iv in bolus and 600 mg/m2 iv infusion over 22h: day 1-2 Every cycle will last 2~          weeks (approximately 48 hours of treatment infusion and 12 days of rest).~           ** 25 Gy in 5 consecutive fractions, one fraction per day in 5 days on CTV (Clinical~          Target Volume) at the isodose of the 95% of the total dose. The treatment plan will be~          elaborated at the work-station dedicated to the Helicoidal Tomotherapy. The treatment~          could be planned also with linear accelerator with IGRT-IMRT technique or VMAT~          technique.~        2. Restaging (week 11)~        3. Surgery (week 12-16) with Total Mesorectal Excision (TME)~        4. End Of Treatment (week 16-32)~        5. Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy~          should be 8 weeks):~        6. FOLFOX4* 8 cycles (every 2 weeks)~      Study Duration: about 5 years. Enrollment period: 36 months. Treatment period: about 8~     months. Follow-up: 1 year.~      NUMBER OF SUBJECTs:~      · Step A: a maximum of 6 patients. 6 evaluable patients are needed to assess toxicity. If 1~     toxicity resulting in discontinuation of treatment will be observed in 6 patients, the~     treatment can be considered safe (with a confidence > 90%).~      If 2 or more toxicity resulting in discontinuation of treatment on 6 patients, the study~     will be stopped because not safe and another type of radiotherapy schedule must be designed.~      · Step B: a total of 50 patients is required to be recruited in 2 years (including patients~     enrolled in Step A).~      The goal is to achieve a proportion of at least 15% of patients with a complete pathological~     response with the new radiochemotherapeutic treatment.~   "
80784|NCT02000037|"~     It is known that the care that is offered to overweigh of class I obese people leads to an~     initial weight loss.~      However, after 12 months, people start to gain their weight back. French National Authority~     for Health suggests that physicians warn their patients against restrictive diets that can~     are the origin of weight's fluctuation can be health threatening. This weight regain is~     linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf,~     2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).~      Due to the difficulties to keep the weight loss, it seems interesting to consider~     alternatives like reflexotherapy. This method seems to act in reducing the dietary urges~     causes by stress, by cravings or by frustration.~      This technique would allow to re-establish normal hormones' or neurotransmitters'~     concentrations mainly involved in the food intake.~      This could be a complementary response to the limits of the classic treatments for weight~     maintenance management, but it needs to be confirmed by a specific study.~   "
80785|NCT02000024|"~     This study is a randomized pilot study to assess the applicability of the Weight Watchers~     model for lifestyle modification to the primary prevention of type 2 diabetes. The approach~     developed by Weight Watchers to achieve weight loss is based on similar nutritional~     principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle~     intervention; monitoring food intake, exercising calorie control, setting modest weight loss~     goals and using physical activity.~   "
80786|NCT02000011|"~     The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic,~     hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical~     resection. For patients aged of 70 years old and more, this surgery is associated to an~     increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive~     geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can~     be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for~     old patient population without cancer, CGA associated with a geriatric intervention plan~     (GIP) allows autonomy preservation, decrease of institution admission, and survival~     improvement. The reference study showed that a CGA associated to a GIP improves survival of~     old patients who had a cancer surgery. However this study included patients from 60 years~     old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following~     hospital discharge.~      We propose to perform a prospective and randomized study to evaluate the impact of a CGA~     with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer~     resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8~     distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status,~     depression, cognitive function and social status. The impact of such a strategy on autonomy~     and survival has never been studied.~   "
80787|NCT01999998|"~     Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent~     cure rates. However, a significant proportion of these patients develop cancers and heart~     diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce~     radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan~     taken following chemotherapy when many of the original sites of the lymphoma are no longer~     visible using a CT scan taken following chemotherapy when many of the original sites of the~     lymphoma are no longer visible.~      In order to safely minimise the volume treated with radiotherapy it is necessary to~     accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning'~     CT scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent~     of the lymphoma, but is taken in a different position to the radiotherapy treatment~     position. This aim of this study is to explore whether a PETCT scan taken prior to~     chemotherapy in the radiotherapy treatment position, in conjunction with advanced software~     to combine this scan with the subsequent radiotherapy planning CT, can be used to more~     accurately identify the lymphoma target. The study aims to recruit up to 20 patients with~     early stage Hodgkin lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will~     be followed at the same session by a PETCT in the radiotherapy treatment position~     appropriate radiotherapy immobilisation devices. Participation in the study will not affect~     treatment decisions or the radiotherapy planning process. The PETCT in the radiotherapy~     planning position will be made available to the treating clinicians. The process of planning~     radiotherapy will not be systematically altered by the study. The study is aimed at~     determining how to improve the radiotherapy planning process in the future, in the hope of a~     reducing in the long term side effects of treatment whilst retaining high cure rates.~   "
80788|NCT01999985|"~     The purpose of this study is to:~        -  Find out if the study drugs Afatinib and Dasatinib can be safely given together to~          patients with lung cancer~        -  Learn how these two drugs work in cancer cells when they are combined~        -  Learn more about the side effects of these two drugs when combined~        -  Find the highest doses of the study drugs Afatinib and Dasatinib that can be given~          safely without causing serious side effects~   "
80789|NCT01999972|"~     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of~     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment,~     while the majority of patients will eventually develop evasive resistance. It is proposed~     that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth~     factor (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining~     a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared~     to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor,~     crizotinib, in combination with the VEGF inhibitor, axitinib.Since this will be the first~     study of axitinib given in combination with crizotinib, the study will primarily assess the~     safety and tolerability of the combination regimen.~   "
80790|NCT01999959|"~     To demonstrate a possible beneficial impact of pertubation we designed a randomized~     prospective study, in which uterine washing was administered prior to insemination in~     patients diagnosed with unexplained infertility.~   "
80791|NCT01999946|"~     The purpose of this study is to compare the effectiveness of extended-release naltrexone~     (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC~     jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort,~     which will result in a naturalistic comparison of XR-NTX vs. an established jail-based~     methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse~     among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among~     XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will~     compare related opioid treatment outcomes post-release across all arms.~   "
80792|NCT01999933|"~     The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb)~     cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or~     concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the~     patients received whole pelvis radiation and were divided into three groups according to~     adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent~     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant~     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side~     effects will be evaluated according to Standard WHO response criteria, and NCI common~     toxicity criteria for adverse events(NCI-CTC-AE) V3.0.~   "
80793|NCT01999920|"~     The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a~     receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week~     treatment course.~   "
80794|NCT01999907|"~     Viral infections are the main cause of asthma attacks in preschoolers, an age group with the~     highest rate of emergency visits due to asthma. While high doses of inhaled or oral~     corticosteroids provide benefits, these have been associated with adverse outcomes. Most~     asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children.~     Low vitamin D level has been linked to more frequent and more severe asthma attacks as well~     as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin~     D supplements can reduce the number of asthma attacks triggered by viral infections in~     children. Unfortunately, most people forget to take vitamin D every day during the fall and~     winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth.~     This has been shown to safely and effectively increase vitamin D levels in children. The~     investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase~     the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared~     with placebo in preschool-aged children with asthma. This six-month pilot randomized~     controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising~     vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled~     participants; and (3) identify problems that may call for protocol changes.~   "
80795|NCT01999894|"~     The purpose of this study is to evaluate the long-term safety and tolerability of memantine~     in the treatment of autism in pediatric patients.~   "
80796|NCT01999881|"~     This randomized pilot clinical trial studies exercise intervention in improving quality of~     life and exercise capacity and reducing inflammation and oxidative stress in patients with~     lung cancer and their support persons. Exercise therapy may help improve quality of life,~     may increase exercise capacity, and may reduce inflammation and oxidative stress in patients~     with lung cancer and their supporters.~   "
80797|NCT01999868|"~     The purpose of this study is to determine if the use of ustekinumab, followed by abatacept,~     will prevent relapse in people with moderate to severe plaque psoriasis.~   "
80798|NCT01999855|"~     For many years, it is known that asthmatics have more often dysphonia. However, no study has~     so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.~      The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time,~     inhaled corticosteroids have been considered as responsible for organic abnormalities of the~     vocal cords. We hypothesized that women with asthma have more often dysphonia, and that~     dysphonia is rather functional origin.~   "
80799|NCT01999842|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.~   "
80800|NCT01999829|"~     Atrial fibrillation remains a major cause of morbidity following cardiac surgery with~     cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a~     strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial~     fibrillation, via A2A receptors modulation.~      The effects of caffeine on the inducibility of atrial fibrillation are actually well-known,~     leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical~     study has demonstrated that coffee drinking was inversely associated with total and~     cause-specific mortality.~      The investigators therefore examined the preventive effects of oral caffeine on valvular~     surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also~     evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A~     adenosine receptors modulation.~   "
80801|NCT01999816|"~     The purpose of this study is to conduct a randomized controlled trial of a lifestyle~     redesign intervention's ability to (1)reduce the incidence of medically serious pressure~     ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the~     intervention's cost-effectiveness and potential cost savings and its effects on~     participants' quality of life.~   "
80802|NCT01999803|"~     This is a phase I, multicentre randomised, double-blind, placebo-controlled trial to assess~     the safety and tolerability of continuous i.c.v. administration of sNN0029 infusion solution~     at a dose of 4µg/day in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
80842|NCT01999283|"~     Exercise has been found to be effective in alleviating back and neck pain. Two exercise~     methods which are available in the community in a group format are Yoga and Pilates. While~     there is some research on the efficacy of these exercise methods for low back pain, there is~     no definitive research on the use of Yoga or Pilates group exercise for individuals with~     chronic cervical pain.This study investigated the effect of group Yoga and Pilates exercise~     compared to a wait-listed control group on impairments and function related to neck pain for~     individuals with chronic cervical pain.~   "
80843|NCT01999270|"~     To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.~   "
80803|NCT01999790|"~     Grave's ophthalmopathy is the most common cause of orbital disease in adults. The clinical~     presentation may vary between sub clinic symptoms to severe ones. The eyelid retraction is~     one of the most important signs of Grave's ophthalmopathy and can lead to cosmetic and~     functional problems.~      The eyelid retraction can be found in the inflammatory stage and in the chronic disease,~     when it is stable. It can be described when the upper lid is contouring the superior limbus~     or positioned above that. This condition can lead to dry eye symptoms, exposure keratitis~     and cosmetic issues. The treatment can may be surgical or medical.~      The medical treatment are usually based on controlling thyroid function and in the use of~     steroids, both are not specific for the lid retraction, but for the inflammation that is~     common in the disease.~      In the longstanding disease, surgery is the most efficient treatment. There are several~     described techniques, they are based on the concept of weakening the muscles that act on lid~     elevation (levator and Muller Muscle).~      Basically the techniques can be divided in two groups: the first with an anterior approach~     (with skin scar in the lid sulcus) and the second using a posterior approach (through the~     conjunctiva).~      In the literature there is no consensus in deciding the best technique, regarding cosmetic~     results, incidence of complications, hypo or hypercorrection.~      In this trial we propose to compare two distinct techniques that are already in clinical~     use. The blepharotomy uses a cutaneous approach and the other a conjunctival approach.~      The patients will be divided in two randomized groups and surgical expected outcomes,~     cosmetics outcomes and complications occurrence will be compared.~   "
80804|NCT01999777|"~     This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared~     with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased~     seizure activity.~   "
80805|NCT01999764|"~     This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on~     adults with impaired dark adaptation.~   "
80806|NCT01999751|"~     This study is a prospective, non-randomized, unblinded case series of patients with~     permanent pacemakers and implantable cardioverter-defibrillators undergoing~     medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center,~     Essentia Health. Patients will be enrolled over a 60-month period and followed for 12~     months, with data collected to evaluate the study's primary endpoint, change in pacing~     thresholds over time, as well as a series of secondary endpoints, including: adverse events,~     symptoms, need to make pacemaker programming changes, and possible artifacts created by the~     pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the~     safety MRI scanning in this population and improve practice models and protocols in the~     future.~   "
80807|NCT01999738|"~     Phase 1, multicenter, open-label, non-randomized, dose-escalation oncology study to evaluate~     the administration of EC1456, BIW on Weeks 1 and 2 of a 3-week schedule (Part A), and to~     assess preliminary efficacy results in focused patients with triple-negative breast cancer~     (TNBC), advanced non-small cell lung cancer (NSCLC) and ovarian cancer treated at the MTD~     (Part B).~   "
80808|NCT01999725|"~     The primary objective of the study is to determine the safety of single doses of orally~     administered EDP-788.~      Secondary objectives of the study are:~        -  To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single~          doses of orally administered drug~        -  To estimate the bioavailability of EDP-788 capsules relative to an oral liquid~          suspension~        -  To estimate the effect of co-administration of food on the absorption of EDP-788~   "
80809|NCT01999712|"~     The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left~     side of the heart of patients with severe heart failure that are awaiting heart~     transplantation or are not transplant candidates. However, while LVAD supports the left side~     of the heart, the right side must work on its own. Sometimes the right side does not~     recover, a condition called right ventricular failure (RVF). This complication increases~     mortality, prolongs hospitalization, requires additional procedures, and increases costs.~     Several risk factors and scores have been proposed to identify patients at risk for RVF.~     However, these methods have proven inadequate; one out of three patients is still~     experiencing right ventricular failure after LVAD surgery.~      Echocardiography, an established noninvasive method to see the heart without radiation or~     risk, has a lot of potential to identify patients at risk for RVF. The questions we will~     tray to answer with this American Heart Association funded project are:~        1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF~          and poor quality of life so we can better select patients for LVAD surgery?~        2. Can echocardiography before scheduled LVAD surgery tell us the course of right~          ventricular function after implantation so we can potentially take additional measures~          and prevent RVF?~      To answer these questions, we will record images of the heart with echocardiography before~     LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients~     for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and~     record the course of right ventricular function with echocardiography.~      Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD~     recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of~     life in suitable patients. However, implantation requires a major surgical procedure with~     associated risks and considerable resources. Thus, careful patient selection is necessary to~     minimize risk for patients and maximize benefit for patients and society. Our long-term goal~     is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer~     alternatives to patients at increased risk for complications and (2) potentially, inform~     earlier LVAD implantation in patients with weakening right ventricular function.~   "
80810|NCT01999699|"~     This study will investigate the response of the immune system to a hepatitis B (HB) vaccine~     in healthy adults 50 to 70 years of age. This study is partially funded by the National~     Institute of Allergy and Infectious Diseases.~   "
80811|NCT01999686|"~     This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over~     6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety~     of DLBS3233 alone, metformin and combination of both, in improving metabolic and~     reproductive parameters.~   "
80812|NCT01999673|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug docetaxel, will improve the results~     of the treatment for non-small-cell lung cancer.~   "
80813|NCT01999660|"~     A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation~     therapy in prostate cancer patients~   "
80814|NCT01999647|"~     This study was designed to assess whether the injection of local anesthetic into the nerve~     (intraneural), as opposed to around it (perineural), requires a shorter time to develop~     surgical anesthesia of the lower leg.~      The investigators will compare the two types of injection using the same drug, so as to~     determine if there is an actual difference onset time. They will also examine the overall~     success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent~     orthopedic surgery.~      The safety of these procedures will be examined by in-hospital and phone-call follow-up~     contacts.~   "
80815|NCT01999634|"~     The aim of this study is to monitor by microdialysis the postoperative outcomes in order to~     identify anastomotic leaks after rectal surgery.~   "
80817|NCT01999608|"~     The role of vitamin D deficiency in female reproduction remains controversial. Early~     retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels~     on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two~     retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy~     rates with an effect mediated through the endometrium.~      Taking into account that knock-out experiments have shown that vitamin D receptor null mice~     not only experience uterine hypoplasia but also impaired folliculogenesis, it might be~     hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian~     reserve. This may be further supported by previous reports demonstrating that serum 25-OH~     Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced~     reproductive age.~      The aim of this study is to examine through a large set of prospectively recruited infertile~     women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted~     biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).~   "
80818|NCT01999595|"~     The purpose of this study is to determine the antalgic of surface electrical stimulation~     with pulse frequencies and pad sizes on blunting pressure pain on healthy human due to~     various temporal and spatial summations of the stimulation.~   "
80819|NCT01999582|"~     To determine the optimal route of administration, dose level, and safety of intravenous and~     subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on~     hemodialysis.~   "
80820|NCT01999569|"~     The purpose of the study is to establish that sustained estrogen levels are the driving~     force for the LH surge, and are thereby necessary for ovulation to occur. We predict that by~     reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit~     ovulation from occurring.~   "
80821|NCT01999556|"~     The purpose of this study is to obtain high quality specimens for molecular studies for the~     identification and characterization of genetic mutations involved in the pathogenesis of~     familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic~     clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for~     molecular analyses. Some specimens sent to Washington University may also be used for~     quality control analyses.~   "
80822|NCT01999543|"~     The study is designed to determine the extent to which a plant-based ingredient on different~     food formats affect blood glucose responses in healthy subjects~   "
80823|NCT01999530|"~     The purpose of this study is to find out whether short term treatment with a~     antihypertensive medication prazosin, can influence the levels of a dopamine in the brain.~     We will examine the levels of dopamine in the the brain using Positron Emission Tomography~     (PET) and Magnetic Resonance Imaging (MRI). We hypothesize that there will be no significant~     changes in dopamine levels in healthy individuals taking prazosin.~   "
80824|NCT01999517|"~     Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography~     that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is~     used during coronary angiography to see the coronary arteries. It has been shown that~     exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some~     high risk patients it progresses into renal failure.~      This research study offers a new possible option to prevent CIN. We propose that if~     intravenous nitroglycerin is given before the procedure it may lower the chances of~     developing contrast-induced nephropathy.~   "
80825|NCT01999504|"~     The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut~     hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along~     the lines of the world Health Organisation dietary recommendations~   "
80826|NCT01999491|"~     The goal of this clinical research study is to find the highest tolerated dose of NC-4016~     that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug~     will also be studied.~   "
80827|NCT01999478|"~     The study is testing a new, safe and effective way for the early detection of colon cancer.~     The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS). This is an optic~     probe which is a small device that uses light (not laser) to assess the colon lining. This~     probe will be used before colonoscopy to identify subjects who do and do not have~     precancerous changes in the colon by capturing the light reflected back from the rectal wall~     and that will be assessed without the need for colonoscopy and bowel preparation (colon~     cleaning). This device may detect early cancerous changes in colon tissue with higher~     accuracy than current tests.~   "
80828|NCT01999465|"~     Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the~     affected arm, results from damage in the prenatal period to the nerves extending from the~     spine to the arm. Proper stretching and exercise of the joints and affected arm from the~     time of diagnosis can greatly assist in the development of healthy movement of the limb.~     Additionally, neuromuscular electrical stimulation has been shown to be an effective~     treatment in other neural disorders and therefore its effectiveness in NBPP is worth~     studying.~      In the case of NBPP patients, the loss in normal arm function can be observed very early.~     Young patients will often neglect using the affected arm or modify motions to avoid the use~     of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or~     placing toys or other objects in the mouth. A goal of this study is to test the~     effectiveness of NMES on the biceps muscle in improving the participant's ability to perform~     normal hand to mouth actions. Additionally, biceps muscle Medical Research Council (MRC)~     strength and active range of motion (AROM) will be tested to examine the increase of useful~     arm movement.~      The subjects of this study are newborns between the ages of 3-6 months who are already a~     part of the University of Michigan Brachial Plexus program. Parents of the children will be~     trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI~     Continuum unit for 30 minutes each day and monthly follow up appointments will be performed~     be the research occupational therapists throughout three month study period.~      Parents of the participants will complete a questionnaire before and during the study period~     to help analyze for confounders and gather data regarding parent compliance and NMES~     effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units~     and sham units will be recruited and compare with data analysis.~      The investigators predict that the NMES will effectively improve the ability of the neonate~     to increase use of the affected arm, specifically in hand to mouth movements and other~     aspects of biceps MRC score and AROM.~   "
80829|NCT01999452|"~     Background Paleolithic diet is a modern dietary regimen based on food eaten during the~     Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits,~     vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic~     is avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for~     Paleolithic diet is based on the lack of type 2 diabetes and associated diseases among~     hunter-gatherer populations. Our group have previously studied effects of Paleolithic diet~     in an observational study in humans, an intervention study in animals and two intervention~     studies in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart~     disease. Our intervention studies showed significant improvement of glucose tolerance,~     HbA1c, blood lipids, blood pressure, weight, waist circumference and satiety on Paleolithic~     diet compared with a Mediterranean-type diet and diabetes diet. Studies by other research~     groups on healthy individuals found that Paleolithic diet lowered weight, waist~     circumference, blood pressure, PAI-1, blood lipids and ectopic lipid deposition, and also~     improved glucose tolerance and insulin sensitivity.~      Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended~     diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases~     in a sufficiently large and well executed study to be included in basis for future dietary~     recommendations.~      Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over~     dietary intervention on 150 patients with type 2 diabetes where the whole study population~     upon finishing the initial dietary intervention is studied as a cohort for another 5 years.~     The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6~     months on recommended diabetes diet separated by 6 months wash-out period. After the initial~     18 month long dietary intervention the study participants are recommended to follow~     recommended diabetes diet with implementation of optional elements from a Paleolithic diet~     for the remaining 5 years of the study.~      The intervention, in the form of diet information, will be given orally and written by the~     study participant's own diabetes nurse or doctor, based on similarly designed written~     information on the two diets. The same intervention was successfully used in our pilot~     study. The study participants will otherwise receive usual treatment.~      Power calculations show that 126 participants are needed to obtain significant results with~     80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with~     the same intervention but slightly healthier participants than the average patient in~     Diabetesregistret showed significant results on HbA1C with only 13 participants.~      Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure,~     blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity,~     monofilaments (detection of peripheral neuropathy) and health related quality of life~     assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as~     medication will be registered before and after each intervention diet. Data on primary and~     secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases~     will be retrieved for up to five years after participants' completion of the dietary~     intervention from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and~     the Hospital Discharge Register (Patientregistret) and compared to expected outcome from a~     statistical model based on the Diabetes register (A new model for 5-year risk of~     cardiovascular disease Cederholm et al 2011) and/or a matched control group from the~     Diabetes register.~      Participants will be recruited nationwide through information to health care personnel in~     primary health care and hospital diabetes clinics and to patient organisations.~     Participants' registration, intervention and data gathering will be administered by the~     participants' own diabetes nurse or doctor via REDCap, a web based tool for secure~     electronic data capture hosted on secure servers with daily back-up by the Library and IKT~     department of the medical faculty at Lund University.~      Dietary evaluation will be made using four day weighed food records on paperforms before and~     after each intervention diet and 6 months after the last intervention.~   "
80830|NCT01999439|"~     To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive,~     radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and~     stiffness) and response to treatment in children and adolescents with newly diagnosed~     eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food~     impaction.~   "
80909|NCT01998399|"~     The purpose of this study is to determine if the drug ticagrelor will be an effective~     treatment for patients with severe community acquired pneumonia. The primary objective is to~     reduce all-cause mortality in the ticagrelor group compared to the placebo group.~   "
80831|NCT01999426|"~     Emergency on-call respiratory physiotherapy cover for children in intensive care is~     frequently provided by physiotherapists who ordinarily work in non-respiratory areas. This~     has produced concerns about the safety and efficacy of on-call treatments and is widely~     recognised as an important clinical governance issue affecting services throughout the~     National Health Service (NHS).~      The aim of this study is to investigate whether emergency on-call respiratory physiotherapy~     services provided in the paediatric intensive care unit (ICU) are safe and effective.~     Further it will explore whether there are any quantifiable differences between specialist~     and on-call physiotherapy treatments.~      The study is a randomised, cross-over study design. Infants and children who are likely to~     require at least 2 physiotherapy treatments in one day are recruited to the study. Both~     physiotherapy airway clearance treatments are administered during a 12 hour period, with at~     least 2 hours between treatments. One is administered by a respiratory physiotherapist who~     works regularly in the ICU and one by a physiotherapist on the on-call rota, who normally~     practises in a non-respiratory clinical area. Treatments are performed in a randomised order~     and outcomes measured before, during and after treatments.~      Physiotherapy staff who consent to participate in the study include:~      Specialist respiratory physiotherapists who regularly work in the ICU Non-respiratory~     physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover~     the ICU overnight and at weekends.~      Patients include:~      the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the~     paediatric intensive care unit and~        1. Require full mechanical ventilation and are well sedated~        2. Are likely to require at least two physiotherapy treatments within the day of the study~          (assessed by an independent senior respiratory physiotherapist) and~        3. Whose parents or carers consent for them to participate in the study. Respiratory~          mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded~          before and after each intervention Forces applied during manual techniques, flow,~          pressure and volume during manual lung inflations, volume of saline and selection and~          order of treatment components are recorded during treatments Adverse events occurring~          during or up to 30 minutes after physiotherapy are also recorded.~   "
80832|NCT01999413|"~     Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to~     daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of~     Younger patients (under 61 years) with high-risk cytogenetics.~   "
80833|NCT01999400|"~     This study is designed to provide data to the FDA correlating pharmacokinetics with local~     availability of medications within the gastrointestinal tract. This study will support the~     establishment of scientifically based standards for evaluating drugs which act locally~     within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify~     how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel~     disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve~     the physiologically based models for drug absorption from the intestine. Information from~     this study in concert with in vitro dissolution data will be used to evaluate in vivo-in~     vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution~     of mesalamine products.~   "
80834|NCT01999387|"~     Food allergy is a potentially life threatening condition. The current practice consists of~     elimination diet and injectable epinephrine in case of a reaction.~      Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and~     peanuts.~      We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent~     to follow patients who completed the program and assess their allergy status and quality of~     life.~   "
80835|NCT01999374|"~     Since its inception, the Diabetes Research Institute (DRI) has made significant~     contributions to the field of diabetes, pioneering many of the techniques used in diabetes~     centers around the world. Through several clinical trials, DRI has demonstrated that~     diabetes can be successfully reversed as a result of islet cell transplant.~      Over the years the following protocols in islet cell transplantation have been initiated:~     2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.~      All of the studies listed above will be source of study subjects for this study.~     Approximately 30 subjects are expected to be enrolled and followed in this trial.~      After islet-cell transplantation in the parent studies, each subject receives maintenance~     immunosuppressive medications.~      The purpose of this protocol is to collect additional follow-up for safety and efficacy from~     subjects with graft function after their completion in their parent study. It is expected~     that most subjects will retain measurable islet function and, in the islet-alone studies,~     continue to receive immunosuppressive medications at the time of completing their parent~     study.~   "
80836|NCT01999361|"~     This is a single-center, prospective, open label study in islet transplant recipients after~     complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.~   "
80837|NCT01999348|"~     The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD~     (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in~     accordance with physician standard clinical practice. All treatment decisions lie with the~     physician.~   "
80838|NCT01999335|"~     The purpose of Phase 1 of the study is to determine the maximum tolerated dose and assess~     the safety, tolerability and activity of oprozomib in combination with pomalidomide and~     dexamethasone in subjects with primary refractory or relapsed and refractory multiple~     myeloma.~      The purpose of Phase 3 of the study is to compare the key outcome measures for subjects with~     primary refractory or relapsed and refractory multiple myeloma who are randomized to either~     oprozomib or placebo in combination with pomalidomide and dexamethasone.~   "
80839|NCT01999322|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and~     insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)~     system in adult subjects with type 1 diabetes.~   "
80840|NCT01999309|"~     Rationale: There is ample evidence that inflammatory processes play a role in the~     pathophysiology of schizophrenia. Although Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)~     have been shown to be able to reduce symptoms in these patients, these drugs either have~     unfavourable cardiovascular side effects or are otherwise not well tolerated. Moreover,~     patients with schizophrenia already tend to have an increased cardiovascular risk. The~     combination of well-established vascular protection and reduction of inflammation by~     simvastatin offers a highly attractive potential to further improve the treatment of~     schizophrenia and related disorders.~      Hypotheses: Daily treatment with 40mg simvastatin in addition to antipsychotic treatment~     reduces psychotic symptoms, improves cognition, attenuates brain volume loss, and decreases~     the risk for metabolic syndrome as well as for movement disorders, when compared to placebo.~      Objective: The primary objective of this trial is to investigate the proposed beneficial~     effect of simvastatin as compared to placebo when given for one year in addition to~     antipsychotic medication to patients with psychotic disorder. We expect lower symptom~     severity as measured with the PANSS (Positive and Negative Syndrome Scale) and less~     cognitive decline as measured with the BACS (Brief Assessment of Cognition in~     Schizophrenia).Secondary objectives are assessment of general functioning, presence and~     severity of metabolic syndrome and degree of movement disorders, and assessments of brain~     volume. Lastly, we examine various immunological parameters in serum and peripheral blood~     mononuclear cells and the experience of childhood trauma.~      Study design: Randomized placebo-controlled double-blind trial.~      Study population: 250 men and women, between 18 and 50 years of age, diagnosed with~     schizophrenia, schizoaffective or schizophreniform disorder (DSM-IV 295.*) or psychosis NOS~     (not otherwise specified) (298.9). Onset of first psychosis no longer than 3 years ago.~      Intervention: Patients will be randomized 1:1 to either 40 mg simvastatin or placebo daily,~     in the form of identical tablets.~   "
80844|NCT01999257|"~     The investigators have developed a new website to educate persons of Ashkenazi Jewish~     ancestry about their increased risk for having children with certain genetic conditions, and~     the genetic testing the investigators offer. This study aims to pilot the website to find~     out whether it is effective and to learn what the investigators can improve.~      Participants in the study will be assigned to one of two conditions:~        1. Standard in-person genetic counselling session to learn about inheritance of Ashkenazi~          Jewish genetic conditions and genetic testing. Participants will fill out two short~          questionnaires, one before and one after the genetic counselling session. They will~          then be given a requisition form to undergo blood draw for genetic testing at the~          Montreal General Hospital test centre.~        2. Use of a web-based pre-test genetic counselling tool to learn about inheritance of~          Ashkenazi Jewish genetic conditions and genetic testing. They will fill out two short~          questionnaires, one before, and one after using the web-based tool. They will then be~          electronically sent a requisition form to undergo blood draw for genetic testing at the~          Montreal General Hospital test centre.~      In both conditions, genetic test results will be communicated by telephone once they are~     available. Participants' genetic test results will not be used in any way for the study.~   "
80845|NCT01999244|"~     Despite continued research on effective interventions, obesity remains a major public health~     issue in the United States. Current treatments, including behavioral weight management~     programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited~     reach, reducing the ability of these treatments to address the population-wide scope of the~     obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and~     provide targeted feedback offer promise to help larger groups of individuals to lose weight.~     Despite the commercial popularity of these products, however, little research has been~     conducted to evaluate their impact on excess body weight or to determine how they should~     ideally be implemented. Two key questions need to be addressed. First, is use of~     self-monitoring technology sufficient to produce weight loss, or must this technology be~     combined with interventionist contact? Second, how cost-effective is a technology-based~     intervention, with and without interventionist contact? The current study is small~     prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC)~     to a technology only condition (TECH) and a technology plus interventionist support~     condition (TECH+INT). All participants will all be given basic weight management information~     knowledge and randomized to one of three conditions. Participants in the self-guided~     self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a~     standard body weight scale, and a pedometer and calorie book; participants in the~     technology-based condition (TECH) will receive an electronic activity monitor and~     WiFi-enabled body weight scale, and will track caloric intake via an associated website; and~     participants in the interventionist contact condition (TECH+INT) will receive the same~     technology as in the TECH condition, combined with weekly interventionist contact delivered~     via telephone. We will compare the impact of each condition on weight loss and investigate~     preliminary cost-effectiveness.~   "
80846|NCT01999231|"~     In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis~     Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.~      24 healthy adults were included as study objects, they were randomly divided into four~     groups of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose~     20μg/mL, 6 person/dose) for single arm intradermal injection.~      The main examination items :vital signs (breathing, heart rate, blood pressure, body~     temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after~     injection, skin reactivity (redness and/or induration) diameter of injection sites,local~     reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse~     events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films~     before and 7 days after intradermal injection .~      Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in~     humans, which can provide a safe dosage range for phase II clinical study.~   "
80847|NCT01999218|"~     This study will evaluate the efficacy and safety of the addition of ertugliflozin~     (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM~     who have inadequate glycemic control on metformin. The duration of the trial will be up to~     approximately 122 weeks. This will include a 1-week screening period, an up to 13-week~     wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week~     double-blind, active comparator-controlled treatment period, and a post-treatment telephone~     contact 14 days after the last dose of study drug. The primary hypothesis of this study is~     that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants~     treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with~     that in participants treated with the addition of glimepiride.~   "
80848|NCT01999205|"~     The participants are twelve small or middle-sized companies. Baseline information about the~     company's practices and employees' physical activity is collected in November 2013 with~     questionnaires and accelerometers. A team is nominated in each company to develop company's~     practices in relation to promoting physical activity and reducing sedentary behavior among~     employees. The teams are supported with materials and meetings and the opportunity to obtain~     physical activity services from the regional offices of the Finnish Sports Confederation.~     The development process is carried out in Fall 2013 and the actions to promote physical~     activity and to reduce sedentary behavior are implemented in the companies during spring and~     fall 2014. The follow-up evaluation with the same measures as at baseline will be conducted~     in November 2014 and depending on financing possibly also in November to assess the~     maintenance of the actions.~   "
80849|NCT01999192|"~     The purpose of this study is to determine the efficacy and safety of three different~     Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active~     rheumatoid arthritis and an inadequate response to MTX alone.~      The overall study duration is 24 weeks followed by a 24 week extension phase.~   "
80850|NCT01999179|"~     The goal of the pilot study is to determine if a multicenter prospective cohort study of~     cancer patients with blood clots associated with catheters is feasible. Cancer patients with~     catheter-related thrombosis treated with one month of anticoagulation will be evaluated for~     for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of~     recurrent thrombosis.~   "
80851|NCT01999166|"~     This study will investigate the genes responsible for osteoarthritis. Individuals with~     osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible~     for this study. Family members may also participate.~      Patients will talk with investigators who will explain the study and its possible~     implications for the patient and family and answer questions. The patient's medical records~     will be reviewed, a personal and family history will be taken, and a physical examination~     will be done. Two procedures may be done including blood sampling (which will be used for~     DNA (genetic) studies) and X-rays (to define osteoarthritis grade).~      If no known mutations responsible for osteoarthritis will be detected, participating family~     members will be interviewed by telephone about their personal and family health history and~     will have a blood sample drawn for DNA testing, and X-rays.~   "
80852|NCT01999153|"~     The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at~     the thin skin graft donor site.~      For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one~     receiving the standard treatment (20 mL of physiologic serum) during the surgical~     intervention in topical use to recover an alginate dressing (Algosteril)and the other~     receive 20 mL of Naropein during the surgical intervention on alginate dressing.~      The hypothesis of the study is the administration of ropivacaine will decrease the~     post-operative pain compared to physiologic serum~   "
80853|NCT01999140|"~     The ICD Registry™ is a nationwide quality program that helps participating hospitals measure~     and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and~     cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry~     captures the characteristics, treatments, and outcomes of patients receiving (ICDs).~     Patient-level data is submitted by participating hospitals on a quarterly basis to the~     American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry~     (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to~     both a volume peer group (number of ICD patients submitted annually) and the entire ICD~     registry data set.~   "
80854|NCT01999114|"~     The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr~     buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo~     in healthy male and female subjects.~   "
80855|NCT01999101|"~     The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD~     patients and to assess the influence of Px-104 on hepatic fat.~   "
80856|NCT01999088|"~     Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods:~     intervention (I) and control (C) in different order (I/C or C/I). Both periods were~     separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:~      During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM)~     products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and~     meat derivatives had to be excluded from the diet.~      During the C period, volunteers consumed identical amounts of meat products that did not~     include functional ingredients (Control Meat (CM)).~      Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey~     breast (FT)), were manufactured mixing the meats with the patented formula®~     (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and~     vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.~      Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were~     prepared without addition of the functional ingredients.~   "
80857|NCT01999075|"~     Duchenne Muscular Dystrophy is complicated by weak breathing muscles and lung infections.~     Lung volume recruitment is a technique performed using a face mask or mouthpiece and a~     hand-held resuscitation bag to stack breaths, inflate the lungs and help clear the airways~     of secretions by increasing the forcefulness of a cough. We believe this will slow down the~     steady loss of lung function, prevent lung infection, and improve quality of life. Our aim~     is to compare the outcome of a group of individuals with DMD treated with standard care to~     another group that also receives lung volume recruitment. If effective, this study will~     change clinical practice by including twice-daily treatment as part of the standard of care~     for individuals with DMD, in order to improve their lung health and quality of life.~   "
80858|NCT01999062|"~     In the proposed research study, we are investigating the feasibility of integrating~     automated planning tools to MR images acquired using a novel MR-guided linac, for on-line~     adaptive radiation treatment. However, these on-line automation tools require further~     technical refinement and clinical validation. The goal of this research proposal is to~     develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment.~     Such an approach will provide early stage breast cancer patients timely access to~     high-quality adaptive treatments without exposure to additional ionizing radiation.~   "
80859|NCT01999049|"~     The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients~     who are blind from retinal degeneration - retinitis pigmentosa. These patients have no~     alternatives. Patients typically can achieve ambulatory vision.~   "
80860|NCT01999036|"~     Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital~     post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of~     Arizona.~   "
80861|NCT01999023|"~     Chronic renal disease is now the tenth leading cause of mortality Taiwan. It is worth to~     study the effect of low protein formula on the retardation of failing renal function,~     decrease plasma homocysteine and oxidative stress and further increase antioxidant~     capacities in patients with chronic kidney disease. The purpose of this study is going to~     investigate the effects of protein formula on renal function, homocysteine , oxidative~     stress and antioxidant capacities in patients with chronic kidney disease. One hundred and~     twenty patients with end stage renal disease (stage 2~4) who meet the inclusion criteria~     will be recruited from Taichung General Veterans Hospital, Taichung. Participant patients~     will be blinded and randomly assigned to either the placebo (n = 60) or low protein formula~     (n = 60) for 12 weeks. Data on demography, anthropometry and medical history will be~     collected, and fasting blood samples and 24 h urine samples will be obtained at week 0, 12~     and 24 during intervention period. The levels of hematological, plasma and erythrocyte PLP,~     plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum vitamin B-12,~     homocysteine, lipid peroxidation indicators, glutathione, total antioxidant capacity and~     antioxidant enzymatic will be measured. Twenty-four hour urine volume will be recorded and~     urine creatinine and urea nitrogen will be analyzed. Creatinine clearance rate will be~     measured. Hopefully, the results of this study could provide more pictures on beneficial~     effects of low protein formula on renal function, plasma homocysteine, oxidative stress and~     antioxidant capacities in patients with chronic kidney disease.~   "
80910|NCT01998386|"~     The specific objective of this study is:~        -  Evaluate and quantify colorimetric changes in young permanent anterior teeth;~        -  Compare the efficiency and efficacy of three gels used for self-administered home~          whitening and an over the counter whitening strip;~        -  Analyze the increase in dental sensitivity in adolescent patients submitted to home~          whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium~          (whitening strips);~        -  Assess sensitivity, comfort and acceptance of whitening strips by patients;~        -  Assess patient satisfaction with the method and material used for home whitening.~   "
80862|NCT01999010|"~     Mood journaling is a cornerstone of self-management in major depressive disorder (MDD).~     Research over the last decade has shown that electronic mood journals are superior to paper~     ones. One potential advantage of mental health telemetry (MHT), which use cell phones to~     collect mood journal data, is that electronic journal data can easily be converted into~     graphical records, allowing people living with MDD to readily spot trends, correlations, or~     patterns in ways that would be quite challenging using paper diaries. This information~     should make it easier to recognize and evaluate changes in mental health status -- the first~     two steps in the process of self-management. The investigators will develop and deploy a~     visualization module for patients with which to explore their own MHT data sets on the same~     cell phones which they record their journals, and test the investigators hypotheses that~     their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii)~     enhance their quality-of-life.~      The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal~     design, with user choice of treatment or withdrawal in the A' stage) study, to explore the~     utility of MHT as a tool for enhancing self-management and QoL for persons living with MDD.~     The aims of this study are to explore the impact of MHT on subjects' self-management and~     QoL, and to gauge participants' perceptions of MHT's utility.~   "
80863|NCT01998997|"~     To address the feasibility of implementing a randomized, educational intervention to prevent~     delirium, directed at family members of hospitalized older (70 years of age or older)~     medical in-patients. Specifically rates of recruitment and acceptance rates of such an~     intervention to family members will be assessed. An estimate of the effect size of this~     intervention will also be calculated. This is a pilot study. The investigators hypothesize~     that this intervention will be feasible and agreeable to family members to perform, with~     acceptance rates exceeding 80%.~   "
80864|NCT01998984|"~     This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2~     trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily~     treatment for 2, 3 or 4 consecutive days compared to vehicle gel~   "
80865|NCT01998971|"~     The purpose of this study is to evaluate the safety, tolerability, and dose regimen of~     daratumumab when administered in combination with various treatment regimens for the~     treatment of multiple myeloma.~   "
80866|NCT01998958|"~     The purpose of this study is to assess the efficacy and dose response of intranasal~     esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with~     placebo in improving depressive symptoms in participants with treatment-resistant depression~     (TRD).~   "
80867|NCT01998945|"~     We will compare two programs that are designed to help older adults who have had fall~     injuries manage anxiety and improve their level of functioning. We expect that both programs~     will provide some benefit, but that one will promote better management.~   "
80868|NCT01998932|"~     Chronic venous ulceration of the lower limb poses a significant problem to patients and~     healthcare providers alike. 1% of the population of Western countries have either an open or~     healed chronic venous ulcer.~      However, the pathophysiological abnormalities are not entirely clear in how raised venous~     pressure translates into the changes seen in the skin culminating in an open ulcer. The~     standard treatment of this condition in the United Kingdom is to undertaken compression~     bandaging of the lower limb.~      In order to further their knowledge of venous ulceration, the investigators seek to~     determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and~     by dividing the groups into healing and non-healing wounds, the investigators may be able to~     demonstrate a difference in the biological profile.~      This work may provide insights into predicting who will respond to treatment and targets for~     treatment in the future.~   "
80869|NCT01998919|"~     This study will evaluate the efficacy and safety of sequential administration of Tarceva and~     gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer.~     Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4~     week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The~     anticipated time on study treatment is until disease progression or unacceptable toxicity.~   "
80870|NCT01998906|"~     This study will assess the efficacy and safety of adding Herceptin to a~     paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF)~     chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene~     amplification. In a parallel observational study patients with HER2-negative disease will~     receive the same chemotherapy without Herceptin.~   "
80871|NCT01998893|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with~     relapsed low-grade centroblastic centrocytic non-Hodgkin`s lymphoma. Patients will receive~     once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a~     second time in case of relapse (defined as progression after complete or partial response).~     The anticipated time on study treatment is <3 months.~   "
80872|NCT01998880|"~     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of~     obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus~     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic~     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles~     of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles~     2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv~     infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or~     chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for~     disease-progression and safety will be at least 5 years. In the US, this trial is~     sponsored/managed by Genentech.~   "
80873|NCT01998867|"~     1. To develop a database containing matched information from dynamic tests of postprandial~          glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and~          clinical information related to diabetes risk obtain through subject interview.~        2. To use the database to identify fasting biomarkers and associated algorithms to best~          predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose~          Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical~          information such as current medication use.~   "
80948|NCT01997879|"~     The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy~     volunteers.~   "
80874|NCT01998854|"~     Study is intended to evaluate the one-year safety and clinical status of patients treated~     for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio~     frequency (RF) ablation system. Particular attention will be directed to recording safety~     outcomes including incidence of uterine cavity synechiae. In addition, information on~     quality of life will be collected.~      Overall study duration (first patient enrolled through last patient exit) will be comprised~     of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment,~     and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an~     individual patient, once enrolled, will be approximately 1 month for baseline observations~     and treatment scheduling, and 12 months for follow up after treatment for a total duration~     of approximately 13 months.~   "
80875|NCT01998841|"~     This randomized, double-blind, placebo-controlled, parallel group, adaptive study will~     evaluate the efficacy and safety of crenezumab versus placebo in individuals who carry the~     PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive~     impairment due to AD or dementia due to AD and are, thus, in a preclinical phase of AD.~     Participants will be randomized 1:1 to receive either crenezumab or placebo subcutaneously~     every 2 weeks for 260 weeks. The study also includes a cohort of PSEN1 E280A mutation~     noncarriers who will be dosed with placebo only.~   "
80876|NCT01998828|"~     This open-label study is to determine the safety and efficacy of momelotinib in participants~     with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet~     received treatment with a Janus kinase (JAK) inhibitor.~   "
80877|NCT01998815|"~     The purpose of this study is to examine how physical activity and lifestyle factors~     influence postoperative recovery and postoperative complications after bariatric surgery.~      The hypothesis is that physically active people, with a healthy alcohol consumption and non~     smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations~     and fewer re-operations, fewer complications as well as a faster recovery after a surgical~     procedure.~      The investigators also hypothesize that possible risk factors for non-surgical postoperative~     complications e g abdominal discomfort are also life-style related factors such as smoking,~     high alcohol consumption, low level of physical activity, as well as other risk factors such~     as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of~     anxiety and/or depression, difficulties with coping with the changed food intake regimen~     after obesity surgery, and generally high sensitivity for painful-sensations and nausea.~      First aim of this study is to investigate how life style factors prior to obesity surgery~     are related to hospital stay, sick-leave, immediate postoperative complication rates and the~     rate of resumption of QoL and normal physical function.~      The second aim of the study is to identify risk factors for the development of chronic~     abdominal discomfort and dumping symptoms after obesity surgery.~   "
80878|NCT01998802|"~     This is a phase III double-masked, randomized, controlled study evaluating the efficacy of~     EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to~     subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730~     subjects at up to approximately 50 centers in the United States will be screened, enrolled~     into the study.~   "
80879|NCT01998789|"~     The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR)~     protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant~     recipients, as determined by renal function, rejection rates, and progression to fibrosis~     (in HCV positive subjects). Additionally, safety profile and tolerability of these regimens~     will be assessed.~   "
80880|NCT01998776|"~     ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases.~     However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel~     bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional~     endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the~     visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for~     capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is~     a recommended noninvasive approach of identifying the source of small bowel bleeding.~      Management of ASA-associated small bowel bleeding is a major clinical challenge since there~     is not a single effective treatment for small bowel ulcer, and continuation of ASA increases~     the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients~     to thrombotic complications. Suppression of prostaglandin synthesis is an important~     mechanism of ASA-induced small injury. Consistent with this theory, preliminary data from a~     case series showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in~     ASA users. However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers~     has not yet been confirmed by prospective randomized trials.~      This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel~     ulcers in Aspirin users complicated by small bowel bleeding.~   "
80881|NCT01998763|"~     This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and~     exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D~     between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to~     placebo or 2000 IU/d vitamin D3 arm, after taking placebo for one week. The study protocol~     was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University,~     Shanghai and all participants provided written informed consents.In this 2-arm RCT we aimed~     to systematically investigate the effect of:~        1. vitamin D3 supplement on serum 25(OH)D levels and the modifying factors;~        2. genetic and non-genetic variants on vitamin D bioavailability;~        3. vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers~   "
80882|NCT01998750|"~     This study aims to investigate genetic causes of early childhood obesity.~      We will enroll children with severe early onset obesity (BMI > 99th percentile) diagnosed~     prior to 6 years of age. We will ask questions about their health, eating behavior and~     perform a brief physical examination. We will collect saliva or blood to perform genetic~     testing. We will also invite family members to participate in the genetic study.~   "
80985|NCT01997398|"~     There is a growing trend in functional neurosurgery toward direct anatomical targeting for~     deep brain stimulation (DBS). This study describes a method and reports the initial~     experience placing DBS electrodes under general anesthesia without the use of microelectrode~     recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.~   "
80883|NCT01998737|"~     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture~     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are~     diagnosed only after several fractures. Furthermore, the progressively aging population will~     increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic~     patients are not diagnosed and does not receive treatment for their condition.~      In this study we aim to investigate the strength of Density Index (DI) for prediction of~     proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI~     for osteoporosis diagnostics by using the International Society for Clinical Densitometry~     guidelines. In addition we aim to investigate how many additional women would be identified~     for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to~     DXA.~      The investigators will start and organize a multicenter study in 5 osteoporosis clinics in~     Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal~     women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the~     FRAX questioinnaire will be asked from everybody attending the study.~      Clinical hypotheses:~        1. Cortical bone thickness is decreased in osteoporosis.~        2. Patient age, weight and height are related to BMD status and therefore are needed in~          BMD estimation (Density Index).~        3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.~        4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have~          significantly higher sensitivity and specificity for osteoporosis/treatment decisions~          than one method alone.~   "
80884|NCT01998724|"~     The main purpose of this study is to determine the feasibility and effects of a 6-month tai~     chi exercise program as compared to a 6-month group walking program and standard care for~     patients with COPD that have recently completed a pulmonary rehabilitation program.~   "
80885|NCT01998711|"~     Aims:~      To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive~     impairment, assisted by family members or friends. To equip persons with mild cognitive~     impairment with specific skills to prevent memory failures and improve the capacity of~     patients and families to cope with everyday memory difficulties.~   "
80886|NCT01998698|"~     The investigators would like to assess whether monovision correction of multifocal lens~     insertion provides more satisfaction to cataract patients following an uncomplicated~     phacoemulsification surgery.~   "
80887|NCT01998685|"~     This study aims to assess if different anesthetic techniques can affect coagulant factors in~     patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).~   "
80888|NCT01998672|"~     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102~     in healthy subjects after 7 days multiple oral dosing.~   "
80889|NCT01998659|"~     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102~     in healthy subjects after single oral dosing.~   "
80890|NCT01998646|"~     The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK)~     of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects.~     This study will also explore the effect of food on the PK of ASP4058.The food-effect~     crossover group was open-label treatment with no placebo control.~   "
80891|NCT01998633|"~     HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation,~     polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent~     primary immune disorders that are typically fatal without Hematopoietic Cell Transplant~     (HCT). However, transplant is often complicated by inflammation, infection and other~     co-morbidities. In addition, these disorders have been shown to be cured with partial~     chimerism, making them an ideal target for the use of reduced intensity approaches, where a~     portion of patients may not achieve full donor chimerism, but instead achieve stable mixed~     chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival~     with decreased Treatment Related Mortality (TRM) in institutional series for patients with~     HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and~     unstable chimerism remain challenges. An institutional case series from Cincinnati~     Children's Hospital demonstrated full or high-level chimerism and improved durable~     engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This~     study aims to test the efficacy of the Intermediate RIC strategy in a prospective~     multi-center study including HLH as well as other primary immunodeficiencies where~     allogeneic transplant with RIC has been shown to be feasible and stable chimerism is~     curative.~   "
80892|NCT01998620|"~     This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients~     with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.~   "
80893|NCT01998607|"~     Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is~     well-recognized in patients with advanced cancer. Detailed information regarding this risk~     is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are~     the most important mechanism for minimizing the risk for ONJ. The study objective is to~     measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content~     pertaining to ONJ in the SPC after commercial availability.~   "
80894|NCT01998594|"~     The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space~     created by removal of the trapezium improves the subject's outcome and subsequent~     functionality of the basilar joint arthroplasty procedure.~   "
80895|NCT01998581|"~     This is a multicenter, double-blind, randomized, controlled study of the safety and~     effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and~     perioral enhancement.~   "
80896|NCT01998568|"~     The investigators conduct this study to access the effect of corneal edema (the~     investigators are particularly interested in those who have the clinical central corneal~     edema) on the variation of intraocular pressure values measured by 3 commercial-available~     tonometers compare to the current gold standard tonometer; Goldmann applanation tonometer.~   "
80897|NCT01998555|"~     The purpose of this study is to evaluate medical cost-effectiveness, reduce the~     psychological risk factors( including hostility, anxiety, depression, and perceived stress)~     in coronary artery disease (CAD) patients and enhance the regulation of the autonomic~     nervous system (including respiration rate, heart rate, distal blood vessel pulse, and~     finger temperament) through web-based cognitive -behavioral group therapy.~   "
80898|NCT01998542|"~     The purpose of this study is to determine the safety and tolerability of personalized~     anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous~     cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy~     or radiation. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich~     Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and~     AlloStim(TM) as an adjuvant. The combination of CRCL and AlloStim(TM) is designed to provide~     all the key components necessary to develop tumor-specific immunity creating the~     inflammatory environment necessary to overcome the HNC immunosuppressive environment,~     breaking tumor immune tolerance, and provision of specific HNC antigens for generation of a~     specific adaptive anti-tumor response.~   "
80899|NCT01998529|"~     The goal of this clinical research study is to find the highest tolerated dose of heated~     cisplatin that can be given to patients with lung tumors. The safety of this drug will also~     be studied.~   "
80900|NCT01998516|"~     Scientific Background~      Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest~     which focuses on personality traits and abilities enabling people to cope with both their~     own feelings as well as those of others. The~     Mayer-Salovey-Caruso-Emotional-Intelligence-Test (MSCEIT) (1) represents a valid and~     reliable instrument which exclusively covers the emotional components of social cognition.~     Recent findings indicate, that social cognitive impairments are useful vulnerability~     indicators and that EI could be an endophenotype for schizophrenia and bipolar I disorder~     (BD I). To confirm the endophenotype theory, studies concerning EI in relatives of~     schizophrenia and bipolar patients are needed. To date, studies on EI in BD patients as well~     as in first degree relatives of patients with schizophrenia or BD haven`t been conducted~     yet. Accordingly, the current study focuses on the four categories assessed by the MSCEIT~     and aims to compare the task performance of patients, their first degree relatives and~     healthy control subjects. We assume that the task performance of relatives lies between that~     of patients and controls. The confirmation of this assumption would verify the trait marker~     hypothesis and could be a next step to identify a heritable endophenotype for schizophrenia~     and BD.~      Hypotheses~      Compared to healthy control subjects patients suffering from schizophrenia or BD I show~     deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and~     their task performance lies between that of patients and healthy controls. Deficits in EI~     are more pronounced in schizophrenia patients than in patients with BD I and are more~     pronounced in siblings of schizophrenia patients than in siblings of patients with BD I.~     Independently of diagnosis, deficits in EI affect patients' functional and subjective~     outcomes.~      Methods~      Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia,~     siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and~     healthy volunteers matched for age, sex, and educational level. Structured clinical~     interviews according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the~     diagnosis of schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and~     Axis II psychiatric disorders (patients, siblings, control subjects). Functional outcome~     will be assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP~     (Personal and Social Performance Scale), subjective quality of life will be examined using~     the BELP (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will~     be used to assess premorbid intelligence.~   "
80901|NCT01998503|"~     This randomized phase III trial is studying the side effects and how well giving induction~     therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation~     (ASCT) compared with ASCT alone in treating patients with newly diagnosed renal AL~     amyloidosis. In this prospective, randomized control study, patients with newly diagnosed AL~     amyloidosis who met the criteria for ASCT were randomized to receive 2 cycles of BD as~     induction therapy followed by ASCT (BD+ASCT) (arm 1) or to receive ASCT alone as an initial~     treatment (arm 2). Hematologic and organ responses were evaluated every 3 months after ASCT.~     All the patients should be followed up for 12 months.~   "
80902|NCT01998490|"~     The overall research aim of this study is to investigate changes in measures related to the~     risk of falls among elderly with dementia participating in animal-assisted or robot-assisted~     interventions. In addition the study will investigate how knowledge transfer occurs among~     involved health personnel, and how knowledge is refined and transformed as practical~     competence. The design will be a prospective and cluster randomized multicenter trial, but~     mixed-methods will be used to target different outcomes. The study population will be~     elderly (age above 65) at nursing homes diagnosed with dementia, or having a cognitive~     deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity~     or robot-assisted activity two times a week for 12 weeks in groups of 4-6 participants.~     Control groups will receive treatment as usual. Research questions:~        1. Is there an effect in use of ordinary and optional medication among elderly persons~          with dementia at nursing homes participating in animal-assisted or robot-assisted~          interventions compared to a control group?~        2. Is there an effect on agitation, restlessness and depression among elderly persons with~          dementia at nursing homes participating in animal-assisted or robot-assisted~          interventions compared to a control group?~        3. Is there an effect on social interaction, activeness and wellbeing among elderly~          persons with dementia at nursing homes participating in animal-assisted or~          robot-assisted interventions compared to a control group?~   "
80903|NCT01998477|"~     The study is designed to evaluate the safety of TIVa or TIVb vaccine in children 3 to < 18~     years of age who are at risk of complications of influenza disease due to underlying~     diseases.~   "
80904|NCT01998464|"~     Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of~     the retina, the tissue that lines the inside of the eye. This inflammation may occur on its~     own or as a result of an infectious, cancerous, or inflammatory disorder.~      Optical coherence tomography (OCT) is an imaging technology that can perform non-contact~     cross-sectional imaging of retinal and choroidal tissue structure in real time. It is~     similar to ultrasound imaging, except that OCT measures the intensity of reflected light~     rather than sound waves.~      The purpose of this study is to see if non-invasive OCT technology can diagnose retinal~     vasculitis as well as the more invasive fluorescein angiography, which requires an injection~     of dye into the vein of an arm of a patient. The study will also compare the mapping of~     blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and~     OCT.~   "
80905|NCT01998451|"~     We found a new Double sphincter which located in the neck of gallbladder，we supposed it may~     be related to control pressure of bile duct.Its formation is related to genetic factors.~   "
80906|NCT01998438|"~     Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease~     perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is~     still unknown. We use three different doses to find which is the optimum dose of tranexamic~     acid in cardiopulmonary bypass cardiac surgery.~   "
80907|NCT01998425|"~     The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung~     cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion~     of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating~     immune escape in NSCLC patients.~   "
80908|NCT01998412|"~     The study will include any patient treated with Iluvien at designated sites in European~     countries where marketing authorization has been granted in order to obtain broader safety~     and usage information.~   "
80911|NCT01998373|"~     Abstract~      Background:~      It is documented that some patient education interventions, preferably with a behavioral~     component included, may improve pain, disability and moods Purpose of the study: the purpose~     of this study was to improve the quality of life and reduce pain in rheumatoid arthritis~     patients.~      Methods:~      Patients were allocated to a patient training intervention group and patient without~     training intervention group. Both groups received routine treatments while the patient~     training intervention group, in addition to the routine treatments received training~     booklets and participated in the training workshop. All the extracted data from the written~     questionnaire were collected and analyzed using SPSS software.~   "
80912|NCT01998360|"~     This study will evaluate a new, minimally-invasive surgical circumcision technique for men,~     which is easy to learn and perform, is safe, and is associated with high patient~     satisfaction and excellent cosmetic results.~   "
80913|NCT01998347|"~     There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus~     5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30%~     to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical~     trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as~     effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with~     cisplatin is evaluated by median survival time, progression free survival,and response rate.~   "
80914|NCT01998334|"~     Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute~     pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially~     Continuous Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP~     patients to control SIRS. But the detail treatment for this is controversial. In this study,~     the investigators aim to evaluate the different effects of three kinds of treatment~     protocols which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for~     first three days in SAP patients. Compare the vital sign, SIRS parameters, and others~     between these three groups. This study will try to find a better way for CBP in patients~     with SAP~   "
80915|NCT01998321|"~     the Purpose of this study was to evaluate the short term outcome of patient specific~     instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee~     osteoarthritis with sever varus~   "
80916|NCT01998308|"~     Study design:~      Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model:~     Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.~      Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.~      Primary outcome measures:~        -  Lower extremity functional scale~        -  Visual analogue scale~        -  Range of motion~        -  Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December~          2012 Estimated study completion date: June 2013 Estimated primary completion date:~          December 2013~   "
80917|NCT01998295|"~     Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia~     and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is~     not known whether the problem exist in Tanzania. This study assessed parasite clearance time~     and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among~     children with uncomplicated malaria.~   "
80918|NCT01998282|"~     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are~     collaborating on a project financed by carbon credits that will distribute household-based~     water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda.~     Prior to the full roll out of the campaign, the implementers are conducting research in~     connection with a distribution among 2000 households in western Rwanda. The objective of~     this matched cohort study (Phase 1B)are to investigate whether the filters and stoves~     delivered in October 2012 are still performing and in use, to determine whether they are~     associated with reductions in exposure to pathogens from drinking water and stoves, and to~     assembly information on health and other conditions necessary for the design of a large~     scale health impact evaluation.~   "
80919|NCT01998269|"~     The study objective is to develop and test a Measure of Drug Self-Management for use in~     clinical settings among patients with hypertension and diabetes.~      While medication non-adherence is a highly recognized public health and patient safety~     concern, it is rarely assessed in a routine and consistent manner in clinical settings. With~     the aging of the US population and rising rates of chronic disease, an increasing number of~     adults are being prescribed multi-drug regimens that require greater self-management skills.~     Despite the complexity of medication use, adherence has most commonly been measured as a~     limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has,~     over time, simplified how we think of prescription (Rx) medication use and directed~     attention away from the full range of tasks associated with effective Rx self-management.~     The field of health literacy research has deconstructed these tasks in considerable detail~     in recent years, and can offer insight into a more comprehensive measurement of patients'~     outpatient Rx use.~      There is a clear need for a brief, yet inclusive, measure of adherence that can be used in~     clinical settings to routinely assess patients' use of complex Rx regimens. Such an~     assessment could be used to guide clinicians in addressing specific patient challenges to~     safe and appropriate medication use. In response to this need, our study proposes to develop~     a new assessment of medication self-management. This unique measure will utilize health~     literacy best practices to promote patient comprehension and ease-of-use; it will also be~     tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the~     tool will be available in both English and Spanish to support use among diverse patient~     populations. Our study aims are to:~        1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype.~        2. Inform the content, structure and delivery of the MeDS through targeted discussions~          with patients, providers and information technology specialists.~        3. Test the reliability and validity of the MeDS among patients with diabetes and~          hypertension~      H1: The MeDS will strongly correlate with other self-report adherence measures.~   "
80920|NCT01998256|"~     Though AV optimization has become a cornerstone in optimization of patients with a cardiac~     resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients~     with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical~     practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to~     an important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony~     syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling~     time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV~     optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes,~     with a correlation to atrial pathophysiology, since until now existing evidence only~     emphasizes a possible hemodynamic benefit of this non invasive intervention.~   "
80986|NCT01997385|"~     The aim of this study is to assess the impact of adapted Automated Peritoneal~     Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and~     larger fill volumes in comparison with conventional APD prescribed a standard continuous~     cycling peritoneal dialysis on the efficacy of dialysis.~   "
80921|NCT01998243|"~     Introduction: bariatric surgery shows an important morbidity and there are some reports that~     have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.~      Patients Methods: Since 2009 we are performing a randomized and prospective study to assess~     the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric~     bypass (GB)] group A vs a control group B with the same type of surgical procedures but~     without preoperative IGB-BIB. All patients coming for both groups were followed at 4-week~     intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the~     dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight~     loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more~     than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least~     30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and~     hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery~     was associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB~     failure.Intragastric balloon failure was considered when the weight loss is less than 10%~     from the initial weight. We defined severe complication whenever the patient had to be~     admitted in the hospital after discharge, new surgeries or transfusions were required or the~     hospital stay was longer than 7-10 days.~   "
80922|NCT01998230|"~     The purpose of this study is to determine the feasibility of early oral food intake~     postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence~     confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients~     with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in~     patients with esophagectomy, the preference for this modality also rests on the traditional~     but undocumented reluctance to allow food at will. These assumed hazards of allowing normal~     food in the immediate postoperative period have not been scientifically tested and should be~     viewed against both the benefits and side effects of any artificial feeding modality.~     Whether early oral feeding after esophagectomy affects the incidence of life-threatening~     surgical complications, shortens the recovery time of bowel function and the postoperative~     hospital stay, improves postoperative quality of life in comparison with artificial feeding~     modality remains unclear. The investigators compared a routine of allowing liquid food at~     will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition~     for the first 7 postoperative days. The main endpoint is the incidence rate of~     complications.~   "
80923|NCT01998217|"~     Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an~     effective approach for stone drainage and pain relief, and general or epidural anesthesia~     has been reported for such procedure. Single infusion of remifentanil has been described in~     ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones.~     Moreover, single infusion of remifentanil might induce several complications, such as~     postoperative nausea and vomiting. The investigators attended to investigated whether~     combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the~     complications.~   "
80924|NCT01998204|"~     Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The~     investigators clinical experience showed a trend of delayed emergence among patients~     undergoing deep brain stimulator (DBS) implantation and pulse generator placement under~     general anesthesia. Abnormal pharmacodynamics might be present among these patients, which~     had never been investigated.~   "
80925|NCT01998191|"~     TITLE A randomized controlled trial to assess the best method for evaluating avoidable~     mortality in hospitals using medical record review.~      DESIGN Randomised controlled trial This trial will be conducted in concordance with the~     CONSORT guidelines for randomised controlled trials.~      AIMS Compare explicit versus implicit case review methods for detecting avoidable mortality~     in patients who have died in hospital Assess the accuracy and efficiency of physicians~     versus nurses in detecting avoidable mortality in patients who have died in hospital~      OUTCOME MEASURES Rate of adverse event detection between explicit and implicit review~     methods Type of adverse event detection between explicit and implicit review methods~      Kappa score of agreement for inter-rater reliability for the above outcomes:~        -  Between individual reviewers within using the same review method~        -  Between different reviewer types.~      PARTICIPANTS Physician reviewers and nurses No patient participation. Case records of~     patients who had inpatient hospital mortality will be reviewed.~      ELIGIBILITY Over 18, Able to consent, English Language Speaking, Able to participate in case~     note review training, appropriate level of clinical experience.~      DURATION 2 years with extension if required and reviewed.~   "
80926|NCT01998165|"~     The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva~     /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during~     maintenance of general anesthesia.~   "
80927|NCT01998152|"~     The purpose is to study the effect of individualized nutritional counselling compared to~     usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal~     cancer during palliative chemotherapy. Secondary, effect on total lean body mass, treatment~     intensity, physical functioning, quality of life and survival will be studied.We hypothesize~     that patients in the intervention arm benefit from individualized nutritional counseling.~   "
80928|NCT01998139|"~     Sepsis is a major global health problem, leading to substantial morbidity and mortality~     despite medical care. The initial diagnosis of sepsis is a clinical challenge, as it is~     based on nonspecific systemic criteria. Excessive endothelial activation is a cardinal~     feature of sepsis and contributes to microvascular leak, edema, circulatory shock and organ~     failure. Activated endothelial cells shed endothelial microparticles (EMPs) which can be~     measured in plasma and are found at low levels in healthy subjects. Elevated EMPs have been~     reported in sepsis, but whether their effect is beneficial or deleterious is unclear. In~     this context, we hypothesize that circulating EMP levels can be assessed as a biomarker~     differentiating sepsis from non-sepsis critical illness. This may also suggest that EMP~     levels correlate with 30-day mortality. We propose to measure circulating EMPs at ICU~     admission in subjects with suspected sepsis. Final diagnoses will be adjudicated using~     standard criteria and 30-day mortality ascertained. Subjects determined not to have sepsis~     will serve as the control group. EMP levels will be correlated with diagnosis to ascertain~     the utility of EMP levels as a diagnostic biomarker for sepsis. For those subjects with~     proven sepsis, EMP levels will be correlated to 30-day mortality to assess EMP level as a~     prognostic marker in sepsis.~   "
80929|NCT01998126|"~     The goals of the overall study are to evaluate a recommended phase 2 dose and the short and~     long term toxicities of the combinations. This is a modified phase I trial of immune~     checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib~     or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma~     kinase) or EGFR (epidermal growth factor receptor) mutation.~      The goals of the overall study are to evaluate a recommended phase 2 dose and the short and~     long term toxicities of the combinations.~   "
80930|NCT01998113|"~     Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's~     trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus~     (GDM), additional studies of oral agents for the treatment of GDM have been published~     (observational, randomized controlled trials (RCT), and trials using other drugs like~     metformin).~      Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including~     4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different~     drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT~     addressing metformin vs insulin).~      Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the~     evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize~     this evidence using meta-analysis tools. Specifically, investigators aim at producing~     distinct meta-analyses for each one of the three drug comparisons. This information is not~     available in the literature since the most recent systematic reviews specifically dealing on~     oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or~     have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)~   "
80931|NCT01998100|"~     The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone~     to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing~     symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the~     two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in~     terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to~     support the survival of existing neurons and stimulate the growth of new neurons and~     synapses. BDNF is important to learning and memory in general and therefore may be~     associated with the learning and memory as it relates to PE and corresponding symptoms PTSD~     improvement.~   "
80932|NCT01998087|"~     In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third~     have stopped, and by six months only half are still providing any human milk for their~     babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers~     exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of~     exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other~     pregnancy and parenting related written information is routinely provided to expectant~     couples. In our study we would like to find out whether providing written breastfeeding~     information in pregnancy and breastfeeding focused support phone calls during pregnancy and~     after the birth of the baby result in better outcomes than providing general~     pregnancy/parenting information and support phone calls. This will be tested by randomising~     women, attending their primary health care provider for routine antenatal visits between 20~     and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an~     intervention focused on general pregnancy and parenting issues, and to a non-intervention~     control group. Women will be followed-up for 6 months after the birth of their baby and data~     will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy,~     breastfeeding difficulties, social support and attitudes toward infant feeding.~   "
80933|NCT01998074|"~     The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly~     developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.~   "
80934|NCT01998061|"~     There have been reports suggesting that continuous administration of epidermal growth factor~     receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which~     gradual disease progression was observed after the establishment of clinical benefit from~     EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival~     benefit has not been formally evaluated.~   "
80935|NCT01998048|"~     Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the~     scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of~     shoulder instability aims at restoration of shoulder stability. The purpose of this trial is~     to investigate the difference in outcome after arthroscopic Bankart operation compared with~     open Latarjet operation in the treatment of a residual instability after a traumatic primary~     dislocation in young males.~   "
80936|NCT01998035|"~     This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I~     followed by a disease focused phase II.~      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and~     dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in~     patients with lymphoma. The safety and toxicity of this combination will be evaluated~     throughout the entire study.~      If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD~     is established, the phase II part of the study will be initiated.~      Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and~     romidepsin for patients with relapsed or refractory T-cell lymphomas.~   "
80937|NCT01998022|"~     Numerous studies highlight the insufficiency of blood pressure control in treated~     hypertensive population [1].~      As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared~     to other french regions. The incidence and prevalence of diabetes and obesity are likely~     explanatory factors leading to this excess mortality [2].~      Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure~     (ESRD) is also higher than the national average. The high prevalence of diabetes,~     hypertension and obesity in this population is also probably responsible for the high~     prevalence of ESRD [3].~      Opportunities to prevent the progression of kidney disease involve an optimal control of~     treatable evolutionary factors.~      Beyond control of diabetes and obesity, optimization of blood pressure control are an~     important factor to consider, as national and international guidelines recommend lower blood~     pressure targets in this population [4]. Knowledge of the disease and treatment goals are a~     key component of hypertensive patient management. Studies have shown that the knowledge of~     hypertensive disease and therapeutic targets were correlated with treatment compliance and~     with the rate of blood pressure control [5]. Patient education and participation of~     non-medical actors (nurses, pharmacists, …) are likely to improve the management and~     treatment compliance of these patients [6]. To our knowledge, no investigation has been~     performed in our region to determine the epidemiological characteristics, the knowledge~     level and blood pressure control in the population of hypertensive patients. The main~     objectives of this observational study are to evaluate, in a treated hypertensive~     population:~      the knowledge level of the blood pressure treatment goals, the impact of patient knowledge~     on this blood pressure control, the potential impact of the patient's comorbidities on his~     blood pressure control.~      Such a study should provide the basis for the feasibility of a large survey.~   "
80938|NCT01998009|"~     The objective of this study is to compare the performance characteristics or accuracy of~     different in-home screening tests for colorectal cancer (fecal occult blood tests), among~     patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria~     and agree to participate in the study are asked to perform one guaiac and two immunochemical~     fecal occult blood tests at home prior to their colonoscopy. After the patient has completed~     and sent in the test kits, the patient then undergoes their previously scheduled~     colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood~     test, including sensitivity, specificity, test positivity rate and positive predictive value~     for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be~     estimated by comparing the fecal occult blood test results with the results of the~     colonoscopy.~   "
80939|NCT01997996|"~     Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP)~     where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia,~     TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M~     (Trademark) is based on a highly flexible material which is partially absorbable. We suggest~     that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be~     used for the treatment of younger and/or sexually active women. This study observes women~     who are routinely treated with PROLIFT+M with regard to their sexual function before and~     after the surgery. The hypothesis is that there is no worsening in vita sexualis with~     PROLIFT+M.~   "
80940|NCT01997983|"~     The investigators believe that this study is of importance of several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel~          in IC patients~        3. If proved effective or partially effective, this mode of treatment will serve as a~          basis for large feasibility study exploring its safety and efficacy aspects.~   "
80941|NCT01997970|"~     This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when~     implementing active workstation at offices compared to conventional office work. The primary~     hypothesis is that this implementation will lead to a significant increase in time spent~     walking per day.~   "
80942|NCT01997957|"~     Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world~     and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma~     has become the second carcinoma killer in China. Surgical resection or liver transplantation~     is the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors~     or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a~     small portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial~     chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard~     treatment of unresectable advanced hepatic carcinoma and has notable advantages in~     controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE~     can significantly increase the local doses of chemotherapeutic agents in the liver, kill~     micrometastases and residual foci after embolization and demonstrate outstanding efficacy~     for treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic~     agent with convenient use and definite efficacy and, when used concomitantly with TACE,~     theoretically can not only effectively control intrahepatic foci but also prevent and~     control extrahepatic metastatic foci. However, this hasn't been verified in clinical~     application. This study is intended to investigate efficacy and safety of the combination~     treatment so as to provide a more effective and safety way for treating patients with~     advanced hepatic carcinoma (Barcelona stage-C patients with concomitant portal vein tumor~     thrombi or extrahepatic metastasis).~   "
80943|NCT01997944|"~     This is an open label study that will be conducted at a single site in China to evaluate the~     safety,tolerability and PK/PD profile of multiple dose of recombinant human serum~     albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration~     of study participation is up to 22 weeks for each subject,including 4 weeks screening~     period.~   "
80944|NCT01997931|"~     This prospective randomised controlled trial was designed to assess the effectiveness of the~     Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management~     decisions in mechanically ventilated ICU patients.~      The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS)~     monitoring will receive less sedation then those receiving standard sedation management.~      The secondary hypotheses are:~        1. Patients with BIS have fewer ventilation days than those receiving standard sedation~          management.~        2. Level of sedation administered will differ according to the critical care experience~          and qualification of the nurse.~   "
80945|NCT01997918|"~     Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell~     transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing~     an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT)~     effect. We and others published that success of this strategy when using an alternative~     human leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is~     the underlying disease. The aggressivity of the rapidly proliferating leukemia seems to~     prevail over GVT effects. A more potent alloimmune response is observed following~     haploidentical HSCT, especially early after haploidentical HSCT. This might be related to a~     fast and large expansion of natural killer (NK)-cells. Their alloreactive effect might~     translate into higher rates of tumor control. On the other hand, non-relapse complications~     (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with~     heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT. The~     use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA~     identical donor has been so far only systematically evaluated in small retrospective single~     center reports. Thus, in this multicenter study we aim to collect data on the extent to~     which participating centers employ haploidentical transplantation in the situation of~     relapse after HSCT2.~   "
80946|NCT01997905|"~     This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when~     placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose~     is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who~     are unable to take Oral Anticoagulants.~   "
80947|NCT01997892|"~     To describe the time course of hemoglobin concentration in EU hemodialysis patients switched~     from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin~     alfa (Aranesp).~   "
80949|NCT01997866|"~     Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services~     and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the~     STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood~     Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of~     Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea.~     They will be followed to determine if treatment of Sleep Apnea improves their quality of~     life and decreases their utilization of the Hospital and Emergency Department (ED).~   "
80950|NCT01997853|"~     Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in~     chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic~     cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing~     any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the~     therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory~     properties. If proven, this can be used as a routine treatment modality.~   "
80951|NCT01997840|"~     Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in~     combination with Pomalidomide and low-dose dexamethasone in patients with~     relapsed-and-refractory multiple myeloma.~      Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide~     and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma~   "
80952|NCT01997827|"~     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns~     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment~     alternatives. Implant therapy is sometimes impossible, however, because of patient-related~     risk factors or economic issues. In such cases therapy with an FDP requires extensive~     removal of tooth structure to provide enough space for the restoration and to ensure~     mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation~     requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges~     meet this demand for minimal invasiveness and have been used clinically successfully.~     Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for~     esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium~     alloy, might be exposed while speaking or smiling or account for a colour change of the~     abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical~     performance of metal-based and all-ceramic RBFDPs has not yet been evaluated under~     randomized controlled conditions. The aim of this pilot study is to calculate the sample~     size that allows us to accept the hypothesis that metal- and all-ceramic RBFDPs are similar~     regarding their clinical performance with adequate statistical power.~   "
80953|NCT01997814|"~     Addition of systemic herbal immunomodulators with scaling & root planing (SRP) may enhance~     the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory~     properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.~   "
80954|NCT01997801|"~     In this prospective double-blinded study, The investigators compared acute postoperative~     pain and rescue analgesic demand during postoperative period after robot thyroidectomy~     between ketamine and placebo groups.~   "
80955|NCT01997788|"~     To evaluate the efficacy and the safety of the intrathecal morphine injection in the open~     nephrectomy.~   "
80956|NCT01997775|"~     The purpose of this study is to determine whether metformin is effective in lowering plasma~     IL-6 level and improving the treatment response in patients with non-small cell lung cancer~   "
80957|NCT01997762|"~     The purpose of this study is to determine if resveratrol supplementation preserves beta cell~     function and insulin sensitivity in post-partum women following a first diagnosis of~     gestational diabetes. We hypothesize that daily supplementation with resveratrol will~     preserve beta cell function and insulin sensitivity.~   "
80958|NCT01997749|"~     The purpose of this controlled, randomized intervention is to investigate whether a~     fat-based (ketogenic) diet given for a week has a positive effect on blood sugar, mortality~     and function in patients hospitalized with acute stroke compared to the effect of a usual~     diet.~      The study hypothesis is that a ketogenic diet and reduced availability of glucose to the~     brain cells will reduce the volume of neuronal damage in the brain and improve function.~      The intervention will take place at the neurological units of Glostrup and Bispebjerg~     Hospital in Denmark.~   "
80959|NCT01997736|"~     The purpose of this study is to collect preliminary safety and effectiveness data evaluating~     the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic~     paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.~   "
80960|NCT01997723|"~     Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased~     cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is~     the gold standard in clinical practice to diagnose OSA but has availability, cost, and~     resource limitations. In the last decade, an alternative diagnostic strategy, Portable~     Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical~     management. In contrast to PSG, PM maybe performed unattended in homes, utilize different~     neurophysiologic and cardiorespiratory parameters, and may synthesize these data~     differently. PM is feasible and is approved by Centers for Medicare and Medicaid Services~     (CMS) in the United States. However, the diagnostic utility of PM in minority and~     underserved populations is not defined.~      African-Americans are more severely affected by hypertension and cardiovascular disease~     (CVD) than other ethnic groups and OSA is more common in this population. OSA is a treatable~     cause of hypertension. Despite this the impact of timely interventions for OSA on health~     outcomes and risk reduction specific to African Americans is unknown.~      Purpose of this research: In view of the vulnerability of this population and the potential~     for improvement in healthcare access for OSA with home-based diagnosis, this study aims to~     establish the feasibility and identify the potential advantages and limitations of~     home-based diagnosis of OSA in a high-risk urban African-American population including~     veterans with frequently limited access to healthcare.~      Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard~     laboratory-based PSG in effectively diagnosing OSA in urban African Americans.~   "
81000|NCT01997203|"~     Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon~     (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects.~     The purpose of this study is to determine the effect of vitamin D on liver affection in such~     patients.~   "
80961|NCT01997710|"~     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns~     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment~     alternatives. Implant therapy is sometimes impossible, however, because of patient-related~     risk factors or economic issues. In such cases therapy with an FDP requires extensive~     removal of tooth structure to provide enough space for the restoration and to ensure~     mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation~     requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges~     meet this demand for minimal invasiveness and have been used clinically successfully.~     Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for~     esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium~     alloy, might be exposed while speaking or smiling or account for a colour change of the~     abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical~     performance of different all-ceramic RBFDP designs has not yet been evaluated under~     randomized controlled conditions. The aim of this pilot study is to calculate the sample~     size that allows us to accept the hypothesis that the two designs tested are similar~     regarding their clinical performance with adequate statistical power.~   "
80962|NCT01997697|"~     Recent studies show that overweight people have a greater sensitivity to the rewarding~     aspect of food due to the disturbance of the dopaminergic system. These perturbations lead~     to a greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to~     food would also facilitate food intake related to emotions, whether they are positive or~     negative. However, the food intake in response to emotions can be modulated by physical~     activity. But, there are no interventional studies in the literature examining the~     behavioral and biological factors related to emotional eating together with the fact, there~     are few data on the explanatory mechanisms. The purpose of the study is to evaluate the~     predictive factors of emotional eating 6 months after a behavior change program adapted to~     the motivational state and to identify the its underlying mechanisms~   "
80963|NCT01997684|"~     The use of colonic stenting with elective surgery has been suggested as an alternative~     management for acute malignant colonic obstruction, as emergency surgery has a high risk of~     morbidity and mortality.~      However, the available body of literature addressing their benefit in this setting is~     contradictory.~      The purpose of this study is to determine the efficacy and safety of colonic stenting with~     elective surgery versus emergency surgery in the management of acute malignant colonic~     obstruction.~   "
80964|NCT01997671|"~     OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to~     improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular~     disease and reducing expenditure in this respect.~      DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical~     records and other primary care databases.~      SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan~     Health Institute (ICS)~      SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been~     started on lipid-lowering therapy during 2 consecutive years of study.~      INTERVENTION: Practitioners in the intervention group may have access, whenever they want~     and through the computerized medical record program, to personalized information on their~     assigned patients who have started treatment of cardiovascular primary prevention with~     lipid-lowering. This information is updated monthly for 12 consecutive months.Information~     will be presented in two different and complementary ways to each practitioner: asynchronous~     information (the patient is not present when the practitioner receives the information) and~     synchronous information (the patient is present when the practitioner receives the~     information).~      VARIABLES:~        1. Primary Outcomes are:~             -  Variable RETIRA: new lipid-lowering treatments initiated during the year prior to~               the intervention, seen as inadequate and withdrawn during the intervention period.~             -  Variable EVITA: New lipid-lowering treatments started during the intervention~               period and considered as inadequate.~        2. Secondary Outcomes are:~             -  Variable COST: total cost of the inadequate new lipid-lowering treatments.~             -  Variable RECORD: recording of the cardiovascular risk.~      2.Other variables:~        -  Principal: intervention/control group assignment of health professional.~        -  Patient variables: demographic and clinical.~        -  Professional variables: quality of care indicators.~      STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be~     performed and subsequently multilevel analysis techniques will be used to estimate the~     effect of intervention according to hierarchic data structure and, in particular, patient~     variables effect.~   "
80965|NCT01997658|"~     Background: Reducing postoperative complications remains a dominant challenge for all~     clinicians. By minimizing the incidence of adverse outcomes, health care costs and patient~     recovery can be improved. A number of studies have documented that fewer postoperative~     adverse events occur with the preoperative use of glucocorticoids (GC). Two small~     manuscripts support the use of GC with particular reference to liver resection.~      Major hepatectomy can be associated with numerous adverse outcomes (hemorrhage, bile leak,~     liver failure, wound infection other infectious complications). This rate approaches 54% in~     some trials. Additionally, the liver is responsible for numerous metabolic functions and~     actively participates in the acute phase response via the generation of inflammatory~     mediators and cytokines. Glucocorticoids play an important role in suppressing the~     over-synthesis of pro-inflammatory cytokines and therefore may assist in reducing~     postoperative complications. These pro-inflammatory cytokines recruit leukocytes at the site~     of injury, leading to hepatic parenchymal cell damage. Decreasing pro-inflammatory cytokine~     ratio may therefore reduce hepatic damage.~      Methods: The investigators will complete a randomized controlled trial evaluating the~     incidence of postoperative complications and overall hospital length of stay in adult~     patients following preoperative vs. no administration of 500 mg of methylprednisolone (MP)~     within 30 minutes of starting a hepatectomy. This trial will employ block randomization and~     intention to treat protocols. Four HPB surgeons at University of Calgary will participate in~     the trial with a planned inclusion of all patients scheduled to undergo hepatectomy in a~     period of 2 years.~      Analysis: Standard statistical analysis will include normally or near-normally distributed~     variables reported as means and non-normally distributed variables as medians. Means will be~     compared using the student's t test and medians using the Mann-Whitney U test. Differences~     in proportions among categorical data will be assessed using Fischer's exact test. A p value~     < 0.05 will represent statistical significance for all comparisons.~      Hypothesis: Preoperative GC administration will decrease the incidence of postoperative~     complications and overall hospital length of stay following hepatectomy.~      Potential Impact: Health care utilization and economics are an expanding area of importance.~     Reducing post-hepatectomy complications are crucial to this end.~   "
80966|NCT01997645|"~     Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the~     third and fourth decade of life. According to Parks classification fistulas have been~     divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric.~     Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in~     high (transsphincteric) fistulas it may affect anal continence seriously.~      Therefore sphincter preserving procedures should be preferred in these cases. Rectal~     advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication~     with high success rate in cryptoglandular fistulas. However, this technique is technically~     demanding and results can be expert depended with wide spread of healing rates (24-100%) in~     individual studies as referred in recent systematic review.~      Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple~     sphincter preserving technique. The success rate varies between 40-95% with low overall~     incontinence rate (6%).~      The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment~     of high perianal fistulas.~   "
81001|NCT01997190|"~     This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural~     effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy.~     Secondary objectives are to evaluate clinical efficacy and biologic activity~   "
80967|NCT01997632|"~     The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that~     only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that~     contains the 3 serotypes of polio). This safety evaluation will be done in young adults.~      If the study vaccine appears to be safe, it will be tested at a later stage in the target~     group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the~     purpose is to use the study vaccine in the future to protect young children against Polio~     serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young~     children to come to a complete eradication of Polio is needed. The standard use of Imovax to~     protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio~     vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has~     been developed.~      The duration of the study will be approximately 6 months. 120 subjects between 18 and 45~     years of age will participate in Belgium.~      During the study there will be 2 groups of subjects. Subjects will be assigned by chance to~     one of these groups. One group will receive one single injection of the study vaccine m-IPV2~     HD (which contains only serotype 2), the other group will receive one single injection of~     the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).~      After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked~     to come to the study centre one more time for the second visit (on Day 8, which is 7 days~     after the first visit). They will also receive 2 follow-up phone calls for approximately one~     month and 6 months after vaccination.~   "
80968|NCT01997619|"~     Complex ventral hernia repair is a significant surgical challenge with high frequencies of~     both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described~     in 2010 recommendations regarding grading and technique of repair, which we have followed~     since November 2011.The purpose of the this study was to evaluate our results after biologic~     mesh repair of complex hernias.~   "
80969|NCT01997606|"~     Product information:~      Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected~     for their ability to clean up house dust mite allergen along with other allergen types.~      Study design:~        -  Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers~          will be compared to untreated, classical bedding covers (placebo).~        -  Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the~          subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months~          (=period A) and, after a wash out period of 1 month, the untreated covers (set~          B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will~          first use the untreated set (set A=placebo) and, after a wash out period the Purotex~          impregnated covers (set B=Purotex).~        -  Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.~        -  Double blind: both the subjects and the investigators will not know to which treatment~          arm the subjects are assigned.~      Study hypothesis:~      We want to investigate:~        -  if there is a reduced concentration of HDM allergen in Purotex covers compared to~          untreated covers in real life~        -  if patients with allergic rhinitis to house dust mite use the Purotex covers, they~          experience an improvement of their quality of life and sleep, and an improvement of~          their allergic symptoms and global discomfort~   "
80970|NCT01997593|"~     The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration~     of ropivacaine in children undergoing laparoscopic surgery.~   "
80971|NCT01997580|"~     To explore electrophysiologic parameters and biomarkers predicting treatment response of~     patients with major depressive disorder To explore electrophysiologic parameters and~     biomarkers predicting suicide risk of patients with major depressive disorder~   "
80972|NCT01997567|"~     The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial,~     whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with~     ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total~     30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day~     elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores),~     postoperative opiate consumption, and time to discharge from the postanesthesia care unit.~     Differences between groups with respect to postoperative quality of life and functional~     scores will also be evaluated.~   "
80973|NCT01997554|"~     The aim of this research project, which is realised with the partnership of the enterprise~     Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an~     earlier screening of hypothyroidism. A serum bank will be conserved in the Centre de~     Biologie Sud (Groupement Hospitalier Lyon Sud).~      The serum samples will be assayed locally for the usual medical support to patients and~     after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the~     new diagnostic test. The results obtained from the two techniques will be compared.~      The validation of this new TSH test represents a major advancement, since it could bring in~     the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic~     patients with subclinical hypothyroidism.~   "
80974|NCT01997541|"~     There will be a difference of the insertion depth between the types of the endotracheal~     tube.~   "
80975|NCT01997528|"~     Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep~     gas flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double~     lumen cannula are measured.~   "
80987|NCT01997372|"~     Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by~     pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte~     globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or~     more and excellent overall survival. However ,there are no clinical trials to illustrate the~     response and complete remission rate with different doses of ATG.And there are no data~     reported on children with SAA so far.~   "
81002|NCT01997177|"~     Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion~     analysis. In order to develop a non-biased tool to monitor competence.~   "
81003|NCT01997164|"~     The primary objective of the study is to investigate the safety and tolerability of~     intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related~     macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).~   "
95120|NCT01812070|"~     This innovative study will compare a newly developed smartphone application for Acceptance~     and Commitment Therapy (ACT) to a smartphone application for traditional cognitive~     behavioral therapy (CBT).~   "
80976|NCT01997515|"~     Laparoscopic surgery for gastric reduction is frequently associated with high levels of~     postoperative pain. Postoperative pain is very often treated with opioids. However large~     doses of opioids can result in respiratory depression with hypoxemia especially in high risk~     patients with obstructive sleep apnea. since a large group of patients undergoing surgery~     for gastric reduction surgery also have obstructive sleep apnea, it is expected that these~     patients are also at high risk for postoperative respiratory depression and hypoxemia.~      Intraoperative ketamine has been used as an effective multimodal agent to reduce~     postoperative pain. However, ketamine alone has not been examined to improve postoperative~     pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is~     unknown if the use of intraoperative ketamine can lead to better overall quality of recovery~     in the same patient population. In addition, ketamine has been shown to improve ventilation~     but it remains to be determined if the intraoperative use of ketamine will result in less~     postoperative hypoxemic events.~      The main objective of the current investigation is to examine the effect of intraoperative~     ketamine on postoperative quality of recovery after gastric reduction surgery. The~     investigators hypothesize that subjects receiving ketamine will have a greater global~     quality of recovery score than the ones receiving saline. The investigators also seek to~     determine if intraoperative ketamine would decrease the incidence of postoperative hypoxemic~     events in the same patient population.~   "
80977|NCT01997502|"~     This protocol is a request from Masimo to assist in the collection of data to be used to~     further refine the accuracy of the monitor's algorithm.~   "
80978|NCT01997489|"~     Fabry disease is a recessively inherited disorder due to systemic storage of abnormal~     metabolites (ceramide trihexocide, in particular) caused by lack of the lysosomal enzyme~     α-galactosidase. Though X-linked, in patient series there are often equal numbers of males~     (hemizygotes ) and females (heterozygotes, probably caused by a mutation in one allele and~     an inactivation on the other allele in the X chromosomes), and many clinical features are~     shared.~      Abnormal storage in endothelial and smooth muscle cells explains morbidity, including a~     shortened life expectancy. This is due to age dependent ischaemic manifestations that affect~     heart, kidney and brain. Angiofibroma is an early cutaneous manifestation, and painful~     acro-paresthesias express juvenile neuropathy.~      Cornea verticillata is an almost obligate ophthalmic finding. The brown-yellow Bowman~     membrane related corneal deposits and teleangiectatic conjunctival vessels are early~     ophthalmic slit-lamp markers of the disorder; further there can be subtle lens opacities.~     Fundus vessel tortuosity is observed in many patients, in particular of the retinal venules,~     but best corrected visual acuity (BCVA) is usually normal.~      After the introduction of enzyme substitution therapy in 2001, ophthalmic examinations were~     scheduled as regular part of the general evaluation of the Fabry patients at Rigshospitalet,~     Denmark. A 10-year ophthalmic state of arts was part of oral presentations at a Copenhagen~     conference in December 2011. In contrast to the common occurrence of systemic vascular~     sequels, only one patient in the series had suffered severe visual loss; this was unilateral~     and occurred years before institution of the enzyme therapy. In 2013, however, another young~     male presented a similar retinal event. Sporadic cases of visual loss are reported in the~     literature, but in larger Fabry series ocular vascular catastrophes appear the exception to~     the rule.~      Following the introduction of enzyme substitution, we found it of interest to present our~     nationwide Danish experience. We focused on retinal vessel morphology and the relation to~     systemic morbidity.~   "
80979|NCT01997476|"~     The purpose of this study is, to develop a standard of care protocol using the combination~     of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate~     endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable~     protocol for performing this combined technique. It is expected that combining these~     procedures will eliminate redundant portions of the procedures, reduce repeat visits to the~     hospital, reduce total recovery time for the patient, and will decrease the associated costs~     of separate procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the~     pancreas becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and~     as the pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal~     function is compromised with diarrhea and weight loss. However, while most physicians can~     readily diagnose patients with severe CP, early CP or minimal-change CP is difficult to~     detect, often due to the lack of radiologic findings, laboratory tests and classic symptoms.~     As a result, clinicians are searching for diagnostic tools which will allow for earlier,~     accurate detection of this disease, with the hope that appropriate therapy can be initiated~     before extensive thickening and scarring of the pancreas occurs.~      Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS),~     hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated~     Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate)~     obtained from the duodenum (the part of the intestine where the stomach opens into the small~     bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic~     disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic~     pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need~     for biopsy or surgery. It is also sensitive in detecting mild disease.~      These procedures are standard of care (the normal care you would receive) for the evaluation~     of CP. The purpose of this study, is to develop a standard of care protocol using the~     combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate~     endoscopic procedures.~   "
80980|NCT01997463|"~     The investigators hypothesize that school-based, direct supervision of daily controller~     therapy will result in more effective asthma control, as assessed by the Asthma Control~     Questionnaire than usual care. Additionally, as the result of enhanced asthma control and~     resulting decrease in health care utilization, school-based, direct supervision of daily~     controller therapy will result in lower cost per quality-adjusted life year (QALY) gained~     than usual care.~   "
80981|NCT01997450|"~     This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live~     attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza~     Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.~   "
80982|NCT01997437|"~     The proposed protocol will involve the replacement of the trachea using a synthetic~     bioengineered scaffold seeded with autologous mononuclear cells as an intraoperative~     solution for patients with with benign and malignant laryngo-tracheal diseases or other~     terminal conditions of the trachea.~      Tracheal transplant is indicated as the only therapeutic alternative in cases where~     instrumental, endoscopic and other evaluations show that the length of residual healthy~     airways (about 6 cm or longer than 50% of the airway length) and the localization and~     extension of the obstruction make it impossible to perform a surgical resection of the~     pathological segment.~      In addition to tracheal surgical transplant techniques, this protocol requires knowledge and~     experience with autologous cell preparation as well as scaffold seeding procedures.~   "
80983|NCT01997424|"~     This study will evaluate the association of non-alcoholic fatty liver disease and diabetes~     mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive~     the following examination:~        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan~        -  blood examination including biochemical markers The statistically calculated sample~          size needed is 340 patients.~   "
80984|NCT01997411|"~     The purpose of this study is to assess how glucagon administered as a puff into the nose~     (AMG504-1) works in children and adolescents compared with commercially-available glucagon~     given by injection. In addition, the safety and tolerability of glucagon given as a puff~     into the nose will be evaluated.~   "
80988|NCT01997359|"~     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.~     However more than half the patients who need HIV treatment are still not receiving~     antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many~     patients start ART late after the HIV disease is very advanced. This results in high death~     rates soon after starting ART. The factors that contribute to late ART initiation are still~     unclear. This study will identify factors that help patients to enroll or prevent them from~     enrolling into HIV care and starting ART on time. We will examine the characteristics of all~     patients initiating ART at study sites. We will also look at potential risk factors among~     patients who initiate ART late (cases) compared to patients who initiate earlier (controls)~     at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods:~        1. Face-to-face interviews with participants using questionnaires~        2. Obtaining clinical data from the electronic patient-level database~      Identifying factors that help patients to start or prevent them from starting ART on time~     will help to direct interventions, programs and policies to reduce early death.~   "
80989|NCT01997346|"~     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.~     However more than half the patients who need HIV medicines are still not receiving this~     antiretroviral therapy (ART), and this can lead to early death from AIDS. One of the~     problems in this region is that patients start ART late, after the HIV disease is very~     advanced. This results in high death rates soon after ART initiation. The way clinic-level~     factors, such as the way services and referrals are organized, how referrals are regarded,~     counseling messages and record-keeping, contribute to late ART initiation is unclear. As the~     second phase of a 3-phase NIH-sponsored project, this study will identify clinic-level~     enablers and barriers to timely enrollment into HIV care and ART initiation. A~     cross-sectional qualitative study will be conducted at 4 selected HIV care and treatment~     clinics and the health facilities in which they are located in Ethiopia. Data will be~     collected using 4 methods:~        1. Data abstraction~        2. Key informant interviews with clinic personnel~        3. Observation of post-test counseling sessions in the VCT clinic~        4. Observation of provider-patient interactions in the care and treatment clinic~          Identifying modiﬁable health facility-level predictors of late ART initiation will~          facilitate implementation of interventions, programs and policies that will increase~          the number of patients who enroll in HIV care and initiate ART early. Additionally,~          results will inform the design of the third phase of the NIH-project referenced above.~   "
80990|NCT01997333|"~     The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an~     antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative~     Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB),~     which CDX-011 binds to. The study will also further characterize the safety of CDX-011~     treatment in this patient population.~   "
80991|NCT01997320|"~     Three months intervention study, investigating the effect of nutrient supplementation~     (including 20g of milk protein) twice daily with or without additional heavy resistance~     exercise three times weekly on muscle size, structure and function in 30 subjects at least~     83 years of age.~      Primary hypothesis is that the group conducting exercise improves muscle size, structure and~     function.~   "
80992|NCT01997307|"~     The Ladies ACS study will investigate the relation between age at menopause and severity of~     coronary artery disease in menopausal women with acute coronary syndromes and clinical~     indication to coronary angiography.~   "
80993|NCT01997294|"~     Statins have been approved to benefit patients underwent percutaneous coronary intervention~     (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential~     Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI~     treatment.~   "
80994|NCT01997281|"~     The aim of this study is to assess whether dietary fiber-enriched cereals effect on~     postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or~     glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2~     diabetes mellitus.~   "
80995|NCT01997268|"~     The purpose of this study is to investigate the effects of SC401B (ethyl esters of~     eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg~     EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia~     (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain~     surfactants that may aid in the absorption of EPA and DHA. Based on the results of~     pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are~     bioavailable in both the fasted and fed states.~      The protocol specified primary endpoint is the difference from the placebo group in the~     percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6~     capsules of SC401B per day. The protocol specified secondary endpoints include percent~     changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C),~     HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory~     variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein~     (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).~      An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6~     capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping,~     fishy taste, upset stomach, loose stools, stools with fishy smell or any other self-reported~     observations will be evaluated. Additional safety measures will include changes in liver~     enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6~     capsules of SC401B and placebo.~   "
80996|NCT01997255|"~     Sturge Weber Syndrome (SWS) is a rare disease that affects the patient's brain and causes~     benign (non-cancerous) tumors to grow in the brain. One of the symptoms of SWS is epilepsy.~     People with epilepsy have seizures. Some patients may also have eye problems and a red mark~     on their facial skin.~      This study is being done to find out if the study drug, everolimus, is safe and has helpful~     effects in patients with SWS who have seizures and are not responding to their current~     anti-epileptic medication.~      The study drug, everolimus (Afinitor®), is supplied by Novartis Pharmaceuticals Corporation.~   "
80997|NCT01997242|"~     The SAS registry will include any patient with previous coronary stenting undergoing any~     type of surgery or operative endoscopic/endovascular procedure at the participating Centers.~     The relevant clinical, procedural and outcome data (within index surgical admission and at~     30 days) will be entered in a specifically designed electronic case record form (eCRF).~   "
81004|NCT01997151|"~     This program of research tested the effectiveness of an iPad delivered multiple behavior~     intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women.~     It was hypothesized that the intervention would reduce the number of health behavior risks~     reported by pregnant women in the treatment group. The target behaviors of the intervention~     are smoking cessation and relapse prevention, stress management, and fruit and vegetable~     consumption.~   "
81005|NCT01997138|"~     This project investigates the relation between acute pain and local inflammation. Pain~     reported by the patients for knee arthroscopy are compared with local changes in~     inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe~     pain are included in a randomized placebo-controlled trial of anakinra given~     intra-articularly.~   "
81006|NCT01997125|"~     The purpose of this clinical study is to allow the investigation of the Neural Bridging~     System for participants with tetraplegia to assess if the investigational device can~     reanimate a paralyzed limb under voluntary control by the participant's thoughts.~   "
81007|NCT01997112|"~     The purpose of this study is to examine if chronic paracetamol dosing increases blood~     pressure in patients with known high blood pressure.~   "
81008|NCT01997099|"~     The purpose of this study is to describe the home healthcare organization ambulatory~     infusion pump programming workflow and the process that was followed to introduce the new~     CADD®-Solis VIP System to each home healthcare organization or facility. In addition, this~     study will characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use~     and satisfaction with the CADD®-Solis VIP System.~   "
81009|NCT01997086|"~     The purpose of this study is to evaluate the effectiveness of two minimal invasive~     endoscopic discectomy, PTED and MED, for the treatment of symptomatic lumbar disc~     herniation.~   "
81010|NCT01997073|"~     Specific Aims: 1) Measure exhalation enthalpy in patients receiving conventional positive~     pressure ventilation during stable hemodynamic conditions. 2) Measure exhalation enthalpy in~     patients following change from two-lung ventilation to one-lung ventilation while minute~     ventilation remains constant.~   "
81011|NCT01997060|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One~     approach to achieve weight loss and change life style is to participate in an intensive~     supervised prolonged life style modification course. The immediate effect is often positive,~     but over time the overall effect is limited as the majority will not maintain weight loss~     and a changed life style.~      The purpose of this study is therefore to characterize the physiological factors that~     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a~     prolonged lifestyle intervention.~      We have the following research questions:~        1. Are there physiological traits and characteristics that mediate better adherence to~          lifestyle changes and weight loss?~        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict~          success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after~          intervention?~        3. How does gender and age influence the capacity to maintain the lifestyle induced~          adaptation in muscle and adipose tissue and maintaining weight loss?~      The study design is a longitudinal intervention and will be based on a lifestyle~     intervention, as it is practiced in a real life setting at Ubberup folk high school.~   "
81012|NCT01997047|"~     Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million~     children under the age of 5 years, every year. This is more than the number of children~     dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management~     protocols for managing serious respiratory diseases in children are 30 years old and are~     greatly in need of updating. The successful establishment of useful clinical management~     criteria for children with respiratory diseases will have benefits for children in low~     resource regions around the world. The goals of the study are:~        -  To determine if children with respiratory distress can be reliably diagnosed under~          low-resource conditions.~        -  To identify the clinical tests that best differentiate pneumonia from wheezy diseases.~          These will be used to establish updated diagnostic criteria for common pediatric lung~          diseases that broaden the current pneumonia algorithm by adding another for wheezy~          illnesses.~        -  The ultimate objective is to improve the management and outcome of acute respiratory~          conditions in children.~        -  Investigators also wish to test the efficacy of a locally developed cell phone oximeter~          probe in a low resource setting.~   "
81013|NCT01997034|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One~     approach to achieve weight loss and change life style is to participate in an intensive~     supervised prolonged life style modification course. The immediate effect is often positive,~     but over time the overall effect is limited as the majority will not maintain weight loss~     and a changed life style.~      The purpose of this study is therefore to characterize the physiological factors that~     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a~     prolonged lifestyle intervention.~      The investigators have the following research questions:~        1. Are there physiological traits and characteristics that mediate better adherence to~          lifestyle changes and weight loss?~        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict~          success in maintaining weight loss and lifestyle changes?~        3. How does gender and age influence the capacity to maintain the lifestyle induced~          adaptation in muscle and adipose tissue and maintaining weight loss?~      The study design is cross-sectional and will be based on a lifestyle intervention, as it is~     practiced in a real life setting at Ubberup folk high school. The investigators will recruit~     former participants of this lifestyle style intervention. 50 % who maintained a weight loss~     and a healthy life style and 50 % who did not.~   "
81058|NCT01996436|"~     The primary objective of the study is to determine the optimal intra-arterial drug treatment~     regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal~     subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days~     post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.~      We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators~     is more efficacious than single agent treatment cerebral vasospasm therapy.~      All procedures done as a part of this study are standard hospital care procedures done to~     treat cerebral vasospasm and all drugs to be used are FDA approved.~   "
81014|NCT01997021|"~     Increasing physical activity in older adults has important implications for treating obesity~     related metabolic conditions, however the interaction of aging- and obesity-related declines~     in physical function may make adding structured exercise particularly challenging for this~     group. Given these challenges, an alternative prescription to traditional structured~     exercise, may be short bouts of intermittent walking scattered throughout the day - this may~     be an effective strategy to increase physical activity, reduce sedentary behavior, and~     improve glycemic control in overweight/obese older adults. The purpose of this project is to~     determine how interrupting sedentary time with short bouts of moderate intensity walking~     affects important metabolic outcomes in older, overweight adults. It would also be of~     interest to compare the effects of short, frequent interruptions in sedentary behavior to a~     traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes~     (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall~     aims of the proposed research are to 1) Determine the effect of performing short bouts of~     moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to~     uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects~     of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m~     walk (CW)) on metabolism.~      The investigators hypothesize that interrupting sedentary time with intermittent walking~     will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be~     as effective at improving metabolism as a single continuous 30 min walk.~   "
81015|NCT01997008|"~     This is a feasibility/pilot test of a set of positive affect skills provided online to HIV~     positive people with elevated depressive symptoms - a Center for Epidemiological Studies~     Depression Scale D (CES-D) score > 10. The investigators will test the feasibility of~     recruitment, retention and acceptability of these skills in an online delivery format,~     determine feasibility and acceptability of daily emotion assessments via text messaging and~     assess efficacy of these skills for improving psychological well-being this population.~   "
81016|NCT01996995|"~     In a sham controlled double-blind trial we aim to establish the efficacy and safety of local~     application of laser therapy in patients with diabetes with onychomycosis and risk factors~     for diabetes related foot complications. Onychomycosis leads to thickened and distorted~     nails, which in turn leads to increased local pressure. The combination of onychomycosis and~     neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes~     related foot complications. Usual care for high-risk patients with diabetes and~     onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No~     effective curative local therapies exist and systemic agents are often withheld due to~     concerns for side effects and interactions.~      Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser~     application on the one-year clinical and microbiological cure rate in a randomised,~     double-blinded sham-controlled design with blinded outcome assessment.~      Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot~     ulcers.~      Intervention: local laser treatment from a podiatrist and the other group receives treatment~     according to a control procedure. The laser procedure will be performed as a sham procedure~     by a second podiatrist.~      Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate~     (clinical and microbiological) after one year.~   "
81017|NCT01996982|"~     This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study~     of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at~     University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The~     proposed research on human subjects will provide data that will be used to improve a~     specialized human heat transfer technique/device. By stimulating specialized blood vessels~     (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase~     local blood flow and thus greatly increase the potential for effective heat transfer between~     the environment and body.~      The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a~     practical, safe, and effective method to raise or lower body temperature in critically ill~     patients.~   "
81018|NCT01996969|"~     Regorafenib is a valuable treatment option for metastatic colorectal cancer patients who~     have progressed after prior standard treatments. Prior progression-free survival data~     suggest that there could be a distinct subgroup of patients that may benefit from~     regorafenib. The aim of this study is to identify predictive biomarker of regorafenib in~     terms of its efficacy.~   "
81019|NCT01996956|"~     The purpose of this study is to evaluate the ability of fluid responsiveness by stroke~     volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital~     cardiac surgery.~   "
81020|NCT01996943|"~     Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it~     has been associated with ethanol use. Understanding how ethanol affects the electrical~     properties of the heart and induces AF has important public health implications. The~     objective of this research is to investigate the mechanistic relationship between ethanol~     and atrial fibrillation in humans by performing a placebo controlled study looking at the~     electrical properties of the heart in patients receiving intravenous ethanol or placebo. The~     investigators hypothesize that ethanol increases the susceptibility of human myocardium to~     atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute~     setting.~   "
81021|NCT01996930|"~     Kidney failure is a devastating illness requiring treatment with dialysis or transplantation~     to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis~     (PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube~     (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the~     peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients~     can have complications at this exit site. One possible complication is over-granulation.~     Over-granulation occurs as the wound attempts to heal and the skin around the exit site~     becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating~     exit site can lead to discomfort, pain, bleeding and harbour infection. More serious~     complications include dialysis failure, sepsis and death. There are several ways to treat~     over-granulation but there is limited research evidence to demonstrate which treatment is~     best. The study aims to compare current standard treatment which involves the application of~     silver nitrate by qualified nursing staff to chemically burn the tissue away, with an~     alternative treatment which involves the application of steroid impregnated tape to the area~     of over-granulating tissue by the patient themselves.~   "
81022|NCT01996917|"~     This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with~     subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient,~     the final skin layer of one breast will be closed with subcuticular suture while the other~     breast will be closed with Prineo™. The treatment will be randomized to left or right~     breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the~     Prineo™ group, with each patient serving as her own control. For this study, the resident~     will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will~     perform this study of incision closure under conditions as similar to normal conditions of~     closure.~   "
81023|NCT01996904|"~     The purpose of this study was to report actual percentage of subscapularis tear in~     concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and~     investigate the amount of contribution of subscapularis repair as to the outcome of whole~     rotator cuff repair in terms of its clinical and radiologic aspects.~   "
81024|NCT01996891|"~     The purpose of this study is to evaluate the effects of a diet that is low in glycemic load~     and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids~     (anti-inflammatory diet) on pulmonary function in pediatric patients with asthma. The~     primary endpoint will be change in forced expiratory volume in one second in response to the~     diet intervention. Secondary outcomes will include additional spirometry measures, fraction~     of exhaled nitric oxide, and assessment of symptomatic asthma control. In addition, we will~     identify potential physiological mechanisms relating diet with lung function, including~     changes in systemic inflammation, insulin sensitivity, and intestinal microbiome~     composition.~   "
81025|NCT01996878|"~     To observe and analyze the correlation between Single Nucleotide polymorphisms (SNPs) and~     the incidence of Parkinson's disease in Taiwanese.~   "
81026|NCT01996865|"~     Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are~     distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with~     direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent~     studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus~     rituximab (R2), supporting further study of this combination.~   "
81027|NCT01996852|"~     This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer.~     144 patients and partners will participate in the study. The purpose of this study is to~     test a new treatment that combines a cognitive-behavioral intervention with medication and a~     vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic~     elements that enhance compliance with medical treatment and increase sexual activity through~     enhancement of the sensual pleasure of sex and partner support.~   "
81028|NCT01996839|"~     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate~     ophthalmic gel~   "
81029|NCT01996826|"~     The goal of this study is to investigate whether using bevacizumab (Avastin®) is both safe~     and effective at decreasing the likelihood of a high-risk corneal graft rejection. Patients~     who are high-risk for rejection have blood vessels growing from the white of the eye into~     the cornea (clear, front region of the eye). The medication is used at the time of surgery~     and in the weeks following surgery. Participants have a 50/50 chance at receiving the active~     study medication or a placebo medication.~   "
81030|NCT01996813|"~     Shoulder arthroscopy is one of the most commonly performed orthopaedic procedures and it is~     often done with the patient in the upright, or beach chair position (BCP).~      There have been multiple reported complications associated with the BCP, including cerebral~     ischemia, loss of vision, ophthalmoplegia, stroke, and even death. It has been reported that~     patients with a body mass index (BMI) of 34 or greater are as much as 12 times more likely~     to experience cerebral desaturation events (CDEs) compared to non-obese patients. CDEs in~     the upright position are hypothesized to be partially related to reduced cardiac preload due~     to venous pooling in the lower extremities which is exaggerated in obese patients. This~     prospective observational study aims to determine if the use of compression stockings in~     obese patients undergoing shoulder arthroscopy in the BCP can reduce the incidence,~     frequency, or magnitude of CDEs experienced by the patient. We predict that compression hose~     will help to reduce cerebral desaturation events.~   "
81031|NCT01996800|"~     This study explores the effectiveness of chiropractic and neuromuscular reeducation as~     complementary and alternative medicine treatment approaches for autism. Our investigation~     maintains the following three hypotheses:~        1. Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in~          children.~        2. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will~          reduce the presentation of autistic symptoms in children.~        3. The presentation of autistic symptoms in children will significantly differ between the~          treatment groups of spinal manipulative therapy and spinal manipulative therapy in~          unification with neuromuscular reeducation.~   "
81032|NCT01996787|"~     The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti~     Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals~     Limited) by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)~      Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens~     maintenance, care and storage.~   "
81059|NCT01996423|"~     The purpose of this study is to determine whether oral vitamin D supplementation improves~     the clinical severity of atopic dermatitis in children. In addition, this study plans to~     evaluate the effects of vitamin D supplementation on several key aspects of the immune~     system of children with atopic dermatitis.~   "
81060|NCT01996410|"~     The goal of this study is to determine if acupuncture improves multiple symptoms associated~     with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue,~     anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and~     peripheral neuropathy (see statistical section). The investigators hypothesis is that~     acupuncture will result in lower MDASI scores over the course of chemotherapy for the~     acupuncture group vs. control group.~   "
81061|NCT01996397|"~     Exploratory, prospective, interventional, non-randomized single-center research study to~     compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG~     to augmentation of left ventricular contractility (LV dP/dt max) at different pacing~     configurations in patients undergoing a CRT-implant. Pacing sites and contractility data~     will be compared to pre operative cardiac ultrasound and MRI metrics.~   "
81033|NCT01996774|"~     Many authors propose the strict avoidance of allergenic food as the only treatment for~     children known to be allergic to certain food. However, it has been observed an increase of~     the frequency and severity of the allergic accidents in these children in the long term.~     Other teams have suggested treating these allergies (in particular peanut allergies) by~     controlled and progressive reintroduction of the allergenic food. A good tolerance and a~     prevention of allergic reactions consecutive to the ingestion of the same allergenic food~     were observed. The immunological mechanisms of this type of treatment are not well known.~      A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg~     allergies after this kind of treatment. Certain experiments realized in mice models testing~     the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+~     , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10,~     leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after~     treating allergies by the reintroduction of the allergenic food, the immunological mechanism~     of acquisition of tolerance is associated to variations in populations of lymphocytes and in~     the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be~     studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2.~     Children without antecedents of allergy or familiar atopy.~   "
81034|NCT01996761|"~     This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized,~     double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute~     stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the~     efficacy of porcine brain peptide to improve motor recovery measured by the improvement~     ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) /~     score of FMA at baseline) in patients with subacute stroke.~   "
81035|NCT01996748|"~     The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment~     of otic eczema.~   "
81036|NCT01996735|"~     Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase~     the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the~     cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This~     mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of~     ticagrelor in patients with an acute myocardial infarction. In the current research~     proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation~     in humans in vivo by ENT inhibition.~   "
81037|NCT01996709|"~     The purpose of this study is to assess improvement of palpebral roughness and associated~     symptoms with 3 months use of Clear Care®.~   "
81038|NCT01996696|"~     In current clinical practice, an acceptable standard treatment for locally advanced prostate~     cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group~     B in this study). However, despite our best treatments, there is a risk that the prostate~     cancer may eventually return. As well, the hormonal therapy that is given to treat the~     prostate cancer is known to cause some harmful effects, with some patients using the~     hormones gaining weight, developing diabetes, having increased cholesterol levels, having~     increased blood pressure, and/or heart problems.~      This study is looking at whether Metformin, a drug that is commonly used to treat diabetes,~     can prevent patients from developing some of the harmful effects of the hormonal therapy. In~     treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents~     patients from gaining weight, decreases their cholesterol levels, decreases the number of~     heart problems and allows patients to live longer. As a result, the researchers in this~     study are hopeful that Metformin will also be beneficial for men with prostate cancer on~     hormonal therapy by preventing them from developing these problems.~   "
81039|NCT01996683|"~     safety and efficacy of different iron chelation therapy in transfusion dependent~     beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.~   "
81040|NCT01996670|"~     We hypothesis a period of early NCPAP before surfactant treatment is effective for treating~     RDS and preventing BPD in very premature infants.~   "
81041|NCT01996657|"~     The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve~     replacements is still controversial due to the different risk profiles of thrombophilia and~     bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or~     prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.~      This study was to evaluate whether elevated D-dimer levels could help to determine the~     intensity of oral anticoagulation in patients with mechanical heart valve prostheses.~   "
81042|NCT01996644|"~     This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication)~     augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa.~     The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be~     reduced more in the DCS relative to placebo condition (c) participants in the DCS condition~     will have a greater increase in Body Mass Index.~   "
81043|NCT01996631|"~     Oxidative stress(OS), inflammation, and endocrine-disrupting chemicals(EDC) were all thought~     as important markers that will impact on female reproductive function. However, the~     cause-result correlations between above parameters were still unclear. Investigator plans to~     design a study to evaluate the OS, inflammation, and EDC and their impact on the menstrual~     cycle and reproductive hormone in Taiwanese women. Ferritin is a ubiquitous intracellular~     protein that is essential for the regulation of iron homeostasis. Serum ferritin level is a~     widely available clinical biomarker used to estimate body iron status. Iron is a strong~     pro-oxidant, and high body iron levels are associated with an increased level of OS that may~     elevate the risk of type 2 diabetes. Mildly elevated body iron stores are associated with~     statistically significant elevations in glucose homeostasis indexes. Furthermore, patients~     with elevated iron stores present not only insulin resistance but also metabolic alterations~     that put them at increased risk of cardiovascular disease. Increased serum ferritin levels~     have been found in women with Polycystic Ovary Syndrome(PCOS). Serum ferritin were highly~     correlated with menstrual cycle and androgens level in women. Homocysteine, a~     sulfur-containing amino acid formed during the metabolism of methionine, exerts cytotoxic~     effects on the vascular endothelium. Hyperhomocysteinemia has been established as an~     independent risk factor for thrombosis and cardiovascular disease, and it may partially~     account for the increased risk of cardiovascular disease associated with insulin resistance.~     Elevated total plasma homocysteine levels have been established as an independent risk~     factor for thrombosis and cardiovascular disease. Studies related to homocysteine and PCOS~     have reported inconsistent results.~      Chronic low-grade inflammation has emerged as a key contributor to the pathogenesis of PCOS~     and obesity. A dietary trigger such as glucose is capable of inciting OS and an inflammatory~     response from mononuclear cells of women with PCOS, and this phenomenon is independent of~     obesity. The correlation between inflammatory markers and reproductive endocrine disturbance~     and consequent complications should be important.Both OS and EDC had been associated with~     PCOS.~      BPA, one of EDC, is an environmental estrogen used in the synthesis of plastics, is a~     high-volume production chemical with widespread human exposure. BPA was been reported in~     several female reproductive disturbance. However, the pathological pathway of BPA impact on~     female reproductive system had not been well-understood. Reactive oxygen species have a role~     in the modulation of gamete quality and gamete interaction. Persistent and elevated~     generation of ROS leads to a disturbance of redox potential that in turn causes OS. The~     first part of our study is aim to evaluate the OS impact on the biochemical parameters in~     women with PCOS; the secondary part of our study is to investigate the BPA on the clinical~     and biochemical of women with PCOS; finally, investigator plans to test the hypothesis that~     BPA might increase OS and then elevated ROS in women with menstrual disturbance,~     furthermore, the role of OS and BPA impact on insulin resistance and metabolic disturbance~     will be also investigated.~      OS, inflammation, and EDCs are all important factors impact on the reproductive competence~     in women. To clarify above problems are critical importance. Investigator then conduct this~     study to demonstrate those problems. Study and control cases will be included. Serum total~     oxidant status, inflammatory biomarkers, total antioxidant status, BPA, and~     clinical/biochemical parameters will be obtained for all cases. OS and BPA will be evaluated~     with all clinical/biochemical parameters for all subjects.~   "
81044|NCT01996618|"~     Investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties,~     has a role in the management of symptomatic ventricular premature beats.~   "
81045|NCT01996605|"~     The purpose of this study is to determine the effect of intrathecal oxytocin on areas and~     intensity of hyperalgesia and allodynia induced by topical capsaicin.~   "
81046|NCT01996592|"~     Many factors influence the development of persistent pain after CS (chronic pain) as well as~     post-partum depression. We are attempting to use trajectory pain methods in an attempt to~     identify those at risk for the development of persistent pain post delivery using a daily~     method of contact for the determination of pain scores. Assessments are also done evaluating~     satisfaction of pain management and maternal/infant bonding opportunities. Physical activity~     is monitored by subject's wearing a Fitbit with correlation being done with pain scores~     obtained over 60 days postop with eligible subjects..~   "
81114|NCT01995708|"~     The purpose of this study is to see if the investigator can help the immune system to work~     against myeloma.~      This study will see if a vaccine made with altered dendritic cells will make T cells work~     against tumor cells. The stem cells collected for the transplant will also be used to grow~     dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then~     will be injected under the skin. The investigators will do lab studies before and after the~     vaccination to find out if the vaccine is working.~   "
81047|NCT01996579|"~     Lactoferrin is a protein that is a component of the immune system. It has many properties~     that could make it the ideal agent for the prevention of hospital-acquired infections.~     Lactoferrin has antibacterial properties (is able to kill or stop the growth of disease~     causing bacteria and fungal organisms), it improves immune function, and can increase the~     growth of beneficial bacteria in the bowel. Lactoferrin has been approved by Health Canada~     as a Natural Health product and is sold in health food stores as a supplement. However,~     given the potential beneficial effects of Lactoferrin, it requires further study as to its~     effects in acutely and seriously ill patients. One potential use which has not been studied~     is for the prevention of infections in critically adult ill patients. The aim of this study~     is to determine the utility of Lactoferrin in this patient population.~      The Lactoferrin that the investigators will be using in this study is extracted from cow's~     milk, where it naturally occurs. Cow lactoferrin has similar properties as that normally~     produced in the human body. This study is being conducted to determine how well a solution~     of Lactoferrin given orally and through a feeding tube helps to prevent infections and~     inflammation in critically ill patients in addition to usual care and other measures that~     are known to be partially effective for the prevention of infections.~   "
81048|NCT01996566|"~     Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic~     acids will be explored. Prior work indicates that there may be a learning effect in~     measuring detection thresholds for free fatty acids. This study is designed to determine the~     number of visits necessary to attenuate this learning effect and also to test whether this~     effect continues across different types of fatty acids or is specific to each fatty acid.~     This will aid in understanding how many visits are required to obtain reliable data and if~     less expensive fatty acids can be used to attenuate learning before testing thresholds for~     more expensive fatty acids.~   "
81049|NCT01996553|"~     The purpose of this study is to establish the rate of radial artery occlusion post~     transradial cardiac catheterization through different modalities.~      The study hypothesis is that specialized imaging can provide specific information to help~     identify hand complications after cardiac catheterization through the wrist.~   "
81050|NCT01996540|"~     Title: The role of early systematic best palliative care versus on request palliative care~     consultation during standard oncologic treatment for patients with advanced gastric or~     pancreatic cancers: a randomized, controlled, multicenter trial.~      Description of Study Treatment:~        1. Interventional arm Patients will receive standard oncologic care and will be assigned~          to early systematic best palliative care. They will meet a member of the palliative~          care team within 2 weeks after enrolment. Thereafter, they shall be visited by a~          palliative care team member every 2 weeks until death. Patients assigned to this~          experimental arm will be evaluated if the total of palliative care visits between T0~          (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention~          has to be oriented by the General guidelines for palliative care: specific attention~          will be paid to assessing physical and psychosocial symptoms, establishing goals of~          care, assisting decision making regarding treatment, and coordinating care on the basis~          of the individual needs of the patients.~           The doctor expert in palliative care, with regular visits in the experimental arm, must~          be a physician dedicated full time to palliative care, that can directly prescribe~          drugs and other interventions, and with a particular attention to physical,~          psychological, and spiritual needs.~           Palliative care doctor must have the possibility to decide about organizational~          arrangements.~           He has to perform the palliative care visit according to Temel indications.~        2. Standard arm Patients will receive standard oncologic care and will be assigned to on~          request palliative care consultation. They will be not scheduled to meet with the~          palliative care service unless a meeting will be requested by the patients, the family,~          or the oncologist. After the time of evaluation (T1) patients will be followed by the~          palliative care services as needed.~      Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks~     ± 3.~      Patients will receive standard antineoplastic treatment in both arms of the study according~     to best clinical practice in each participating centre.~   "
81051|NCT01996527|"~     This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in~     measuring treatment response in patients with high-grade glioma. New diagnostic procedures,~     such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in~     measuring treatment response in patients receiving treatment for high-grade gliomas.~   "
81052|NCT01996514|"~     We hypothesized that FA in a TV program watched during a meal, would block satiety responses~     to pre-meal energy consumption and delay satiation in OW/OB but not in NW boys and girls.~     Food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or~     sweetened noncaloric beverage with or without the presence of food advertisements.~     Subjective appetite will be measured as well.~   "
81053|NCT01996501|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets~     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a~     washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81054|NCT01996488|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets~     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a~     washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81055|NCT01996475|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,~     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest~     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81056|NCT01996462|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,~     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest~     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fasted~     study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81057|NCT01996449|"~     Hypertensive patients often show an exaggerated rise in blood pressure during exercise~     through overactivity of the exercise pressor reflex. An increasing body of evidence suggests~     a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We~     hypothesize that this effect of aldosterone is mediated by its direct action on the central~     nervous system and that administration of mineralocorticoid receptor antagonists constitute~     an effective treatment for EPR overactivity in hypertension, independent of reductions in~     resting BP.~   "
81062|NCT01996384|"~     The investigators research project is a randomized, controlled, single-blinded, feasibility~     pilot study. The investigators will study the feasibility of a novel treatment for women~     with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine~     is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment~     commonly used for other pain disorders. The investigators will compare two types of~     acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5%~     lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient~     to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine~     cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV~     pain.~   "
81063|NCT01996371|"~     The purpose of this study is to compare the healing of the patients spine at 24-months~     following surgery and screw placement among 3 groups. The doctor will also compare clinical~     outcomes and the immediate and delayed medical and surgical complications among the 3 study~     groups. The goal of this study is to determine if treating patients with one of the 3 groups~     is better than the others.~   "
81064|NCT01996358|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by~     sugammadex. The investigators compare the intubating conditions, incidence of postoperative~     myalgia (POM) as well as patient satisfaction for these two muscle relaxants.~   "
81065|NCT01996345|"~     The purpose of this study is to perform a large multi-center randomized trial comparing the~     role of vaginal pessary versus expectant management in women with placenta previa between~     22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes~     will assess duration of antepartum admission, total blood loss, gestational age at delivery,~     type of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use~     of a vaginal pessary in patients presenting with placenta previa between 22-32 weeks will~     decrease delivery prior to 36 weeks as compared to expectantly managing these patients.~   "
81066|NCT01996332|"~     This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced~     NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The~     anticipated time on study treatment is 3-12 months.~   "
81067|NCT01996319|"~     This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on~     pulmonary function and average physical activity levels in patients with moderate to severe~     Chronic Obstructive Pulmonary Disease (COPD).~   "
81068|NCT01996306|"~     The primary purpose of this study is to determine the non-inferiority of overall survival~     XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as~     Second-line therapy in Patient with Metastatic Colorectal Cancer.~   "
81069|NCT01996293|"~     This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during~     pregnancy for women with Bipolar Disorder. The investigators predict that the concentration~     of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum.~     Because the concentration of the medication is likely to decrease during pregnancy, it is~     important for doctors to know how much they should increase a patient's dose in order to~     prevent worsening of Bipolar symptoms. In this study, the investigators will ask that~     participants complete up to five overnight visits to our clinical research unit where their~     blood will be drawn every couple of hours, through an IV catheter, to measure how the~     concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated~     for their time.~   "
81070|NCT01996280|"~     Culturally-tailored empirically-based interventions are needed because Latinos suffer a~     greater burden of alcohol-related health disparities and negative social consequences~     compared to other racial/ethnic groups, are less likely to initiate and to remain in~     treatment, and are more likely to live in communities with a high density of alcohol~     outlets. Pilot data from the PI's (New Investigator) K award (AA014905), which will serve as~     the basis for the current proposed larger-scale study, demonstrated that culturally tailored~     motivational interviewing (CTMI) outperformed motivational interviewing (MI) that was not~     tailored to the needs of Latino heavy drinkers. The public health impact of this study will~     be to develop a program of early screening and brief intervention to reduce hazardous~     drinking among Latinos, to minimize the burden of illness and social consequences that~     disproportionately affect Latino communities.~   "
81071|NCT01996267|"~     This study compares two schedules of upfront chemotherapy in HER positive breast cancer.~   "
81072|NCT01996254|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) can safely and effectively reduce post-amputation pain. This study involves a~     device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to~     nerves in the residual limb. The SPRINT System includes a small wire (called a lead) that~     is placed through the skin in the upper leg. It also includes a device worn on the body that~     delivers stimulation (called the SPRINT Stimulator).~   "
81073|NCT01996241|"~     This trial is evaluating an intervention to support adolescent girls from marginalised~     communities in northern Karnataka State, South India to complete secondary school, thereby~     reducing their vulnerability to HIV infection from early marriage and entry into sex work at~     young ages. The intervention will test innovations to address both supply and demand side~     barriers to girls' completion of secondary school, and will have long-term educational and~     livelihood benefits, in addition to reducing vulnerability to HIV.~      School-based constraints will be addressed by improving academic outcomes through teacher~     training and academic support to students; addressing gender-related and skill-based gaps~     among teachers; training of local female teachers; and increasing the content knowledge of~     secondary school teachers. Demand side barriers will be addressed by reducing economic~     pressures that households face to withdraw girls' from school; building appreciation and~     value of girls' education; building family and community accountability for school~     attendance; creating safe spaces for girls and strengthening their agency; and engaging boys~     in promoting and supporting girls' education.~      Primary stakeholders will include teachers and students, especially adolescent girls in the~     school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will~     include school development and management committees (SDMCs), families, boys and the~     communities that are served by the schools. The intervention will cover 125 high schools in~     Bagalkot and Bijapur districts. The intervention will be implemented in collaboration with~     the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent~     Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the~     Institute for Advanced Studies in Education (IASE), Gulbarga.~   "
81115|NCT01995695|"~     H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory~     disease in humans in China. The purpose of this study is to evaluate the safety and~     immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy~     adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3~     months later.~   "
81074|NCT01996228|"~     Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces~     their pancreatic islet beta cells and thereby limits insulin production. Millions of~     individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D~     is increasing annually. Insulin supplementation is not a cure. It does not halt the~     persistent autoimmune response, nor can it reliably prevent devastating complications such~     as neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has~     proven elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao~     and his team have successfully developed a groundbreaking technology Stem Cell Educator~     therapy (Zhao Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients~     have demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of~     T1D and other autoimmune-associated diseases. Here, the investigators will evaluate the~     safety and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.~   "
81075|NCT01996215|"~     This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients~     with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and~     function. The study team will assess whether the brain signatures associated with specific~     cognitive deficits differ in older adults with and without AMD.~   "
81076|NCT01996202|"~     This is a pilot study assessing the safety of the combination of ipilimumab administered~     concurrently with radiotherapy for patients with locally advanced or unresectable melanoma~     and patients at high risk for recurrence after resection.~   "
81077|NCT01996189|"~     The primary objective is to compare the difference in the pain score in radial arterial~     puncture using the insulin needle versus the standard 23G hypodermic needle.~   "
81078|NCT01996176|"~     The purpose of the study is to test an intervention aiming to reduce sitting time during~     work hours among office workers.~      Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day~     (primary). Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks~     increased by 3 pr. day (primary). 20 % of participants report a reduction of musculoskeletal~     pain (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5~     % in bodyfat (secondary).~   "
81079|NCT01996163|"~     Postoperative pain is a major concern in routine management of children admitted to~     pediatric intensive care treatment. There are significant negative physiological and~     psychological ramifications of postoperative pain such as impairment of cardiac function due~     to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative~     and paralytic drugs and reduced patient cooperation in the healing process.~      The main body of evidence dealing with gender differences in pain perception and treatment~     stems from studies in the adult and adolescent population as the gonadal hormones have a~     central role in the way one experiences pain The hypothesis of this study is that there is a~     difference in the perception of pain, the amount of analgesia used and the response to pain~     medication between male and female infants undergoing craniosynostosis repair or untethering~     of cord.~   "
81080|NCT01996150|"~     This is pilot, mechanistic study to address whether bleach baths given to adult subjects~     with atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus,~     will significantly alter their skin microbiome and in so doing improve their skin barrier,~     diminish expression of inflammatory proteins in the skin and improve itch. To answer these~     questions the investigators will perform a 3-month, pilot, investigator-initiated,~     single-center, open-label clinical study. This study will allow us to test the following~     hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths~     will diminish the local inflammatory response in the skin, and 3) that bleach baths will~     improve validated measures of itch (also called pruritus).~   "
81081|NCT01996137|"~     An exploratory clinical study on a Variable Speed and Sensing Treadmill system(VASST) for~     hemiparetic gait rehabilitation after stroke.~      Building upon the positive results of VASST I conducted in 2012, VASST II will be an open~     label pilot trial of 11 subjects screened for eligibility by TTSH medical and rehabilitation~     team Study hypotheses : Training on VASST may result in a gain of +40% - 50% for distance~     walked and +10-20% of gait speed compared to baseline and response rate of 85% and serious~     adverse event rate of <10%.~   "
81082|NCT01996124|"~     Chronic Obstructive Pulmonary disease (COPD) is one of the major clinical entities that~     causes thousands of deaths every year all over the world and weights a lot on the health~     care system of every country in terms of direct and indirect costs. The physiopathological~     modifications that characterise COPD are represented by irreversible (sometimes partially~     reversible) airflow obstruction, and bronchiolar inflammation. Lungs that develop emphysema~     lack of elastic recoil and imply increased resistances and airflow obstruction due to loss~     of lung parenchyma and supporting elastic structures. All these modifications produce air~     trapping and so lung hyperinflation. The latter is precisely the cause of the symptoms and~     particularly dyspnoea which is often heavily perceived by COPD patients and that drives to~     the limitation of daily activities. Lung hyperinflation and the other alterations that occur~     in COPD imply gas retention and increase in pulmonary vascular resistances. Considering that~     the rib cage has limited elastic properties, the effects of gas trapping and lung~     parenchymal damage on mediastinum and particularly on heart mechanics is indisputable.~     Together with alveolar hypoxia, lung hyperinflation is responsible for the development, as~     the disease progresses, of the cor pulmonale. Tha latter causes pulmonary hypertension and~     increased mechanic load during right heart chambers contraction and relaxation. Those~     alterations may effect left heart chambers too.~      Airflow obstruction in COPD is usually treated by inhaled bronchodilators and~     corticosteroids. The main and most used bronchodilators are represented by beta 2 agonists~     (short, long and ultra-long acting) and anticholinergic inhalatory drugs, which can be also~     short, long and ultra long acting. Among ultra long acting beta 2 agonists, indacaterol is~     characterised by quick onset of action (5 minutes), and guarantees an effective~     bronchodilation duration of 24 hours. It is also known that it has an important effect on~     reducing lung hyperinflation decreasing residual volume and consequently allowing an~     increase of inspiratory capacity. The purpose of our study is to evaluate the effects of~     indacaterol on lung hyperinflation in COPD subjects of any stage and with lung air trapping,~     and the consequent potential effects on heart performance evaluated by cardiac trans~     thoracic echo color doppler.~   "
81083|NCT01996111|"~     This is a prospective, controlled, randomized, blinded and comparative, single-center~     clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis~     symptoms that have received standard of care versus treatment with differing amounts of~     injectable dehydrated human amnion/chorion membrane micrografts(dHACM).~   "
81084|NCT01996098|"~     The purpose of this study is studying icotinib following chemotherapy to see how well it~     works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC~     harboring EGFR mutation.~   "
81116|NCT01995682|"~     The study is to evaluate the feasibility of the NLA tool, a combined assessment of~     nutritional and physical functional status, to provide personalized advice for the~     independence and mobility of elderly.~   "
81085|NCT01996085|"~     Arterial hypertension (AH) is an important clinical social and economic problem. In the~     pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention,~     increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG)~     is a simple and safe, non-invasive method of hemodynamic monitoring which allows~     simultaneous assessment of i. e. BP, cardiac index, heart rate, the fluid content in the~     chest and systemic vascular resistance.~      The detailed effect of treatment based on ICG has not been evaluated so far in the long-term~     observation and for other clinically relevant parameters, such as central blood pressure,~     left ventricular hypertrophy, metabolic disturbances, parameters of antioxidative-oxidative~     balance and endothelial function. Therefore, the following main objectives of the study were~     defined:~        -  Evaluation of usefulness of impedance cardiography in optimizing treatment of patients~          with hypertension in the area of reduction and control of blood pressure, hemodynamic~          parameters, biochemical markers and quality of life.~        -  Evaluation of complex pathophysiological mechanisms associated with hypertension~          including hemodynamic, anthropometric, psychological and biochemical parameters as well~          as the effect of antihypertensive treatment on these phenomena.~      The study will be randomized (1:1), prospective and controlled in parallel with conventional~     treatment. The subjects will be divided into groups according to the pre-established random~     order:~        1. empiric group (GE), in which treatment choice will be based on clinical data and~          current guidelines~        2. hemodynamic group (HD), in which treatment choice will be based on clinical data and~          current guidelines considering hemodynamic parameters established with ICG method.~      All patients will undergo a detailed examination three times: before treatment, then after 3~     and 12 months of treatment.~      The authors expect that the study will consolidate the importance of ICG in the diagnosis of~     patients with AH. Simultaneous multiparametric evaluation of the subjects guarantees a~     unique and innovative results which can enhance our knowledge in pathophysiology of AH and~     reversibility of adverse mechanisms associated with this disease.~   "
81086|NCT01996072|"~     Primary hyperparathyroidism is a significant medical and public health problem in the world~     and affects approximately 100,000 new patients in the United States alone. If left untreated~     this can lead to renal stones, osteoporosis, fatigue, and depression. The best treatment for~     primary hyperparathyroidism is surgical parathyroidectomy. However surgical~     parathyroidectomy can be difficult due to the variant location of the parathyroid glands. Up~     to 5% of patients leave the operating room without surgical cure.~      Primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent~     imaging. This would allow surgeons to identify the parathyroid glands and resect the~     suspicious parathyroid glands. Folate receptor (FR) has been found to be over-expressed in~     parathyroid tissue and not thyroid issues. An ideal surgical treatment would combine~     FR-specific fluorescent tracers with intraoperative imaging. It is important to note that FR~     is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the~     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low.~      A group well known to us in the Netherlands has completed a pilot study utilizing a~     folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in~     Mayo have subsequently performed this study on 20 more patients without any serious adverse~     events (personal communication). They report excellent sensitivity and specificity with this~     technique with only grade 1 side effects (allergic reaction). All side effects reversed when~     the injection was halted. Patients with a history of allergic reactions to insect bites~     should not participate (fluorescein is derived from the firefly insect, folate is an~     essential vitamin).~      A fluorescent contrast agent (folate-FITC or EC17) will be used to determine if it will~     localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid~     surgery.~   "
81087|NCT01996059|"~     The purpose of this study is to find out whether the nutritional status of patients~     undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total~     Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received~     total gastrectomy.~   "
81088|NCT01996046|"~     This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer~     that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start~     of new breast cancer hormone treatment and again at 12 weeks after treatment start. The~     baseline uptake and change in uptake after the repeat scans will be compared to clinical~     long term outcomes such as time to progression and overall survival. In addition the uptake~     will be compared to the incidence of skeletal related events that are common occurrences in~     patients with cancer that has spread to the bones.~   "
81089|NCT01996033|"~     The purpose of this observational study is to further evaluate the safety and performance of~     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled~     hypertension in clinical routine practice.~   "
81090|NCT01996020|"~     Transfontanellar Doppler can measure the velocity at both the carotid artery and the~     anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients.~     This study can provide reference value of appropriate cerebral blood flow velocity during~     pediatric cardiac surgery.~   "
81091|NCT01996007|"~     Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and~     middle ear infections), blood poisoning, and meningitis. It is frequently carried by people~     in back of the throat without symptoms. Pneumococcal carriage in the Thames Valley region~     has been studied over the last 12 years with carriage rates having been shown to be~     reflective of disease potential and hence vaccine effect. During this time pneumococcal~     vaccines have been introduced into the routine immunisation schedules of this community. The~     PCV7 (A vaccine against 7 types of pneumococcus) vaccine has subsequently been noted to have~     had a significant impact in reducing vaccine serotype carriage and disease. Herd protection~     (indirect protection of unvaccinated individuals) has also been implicated with vaccine~     serotypes not being carried in parents of vaccinated children. The most common serotype~     carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A~     vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine~     immunisation schedule, however its impact on carriage and disease in this community is yet~     to be evaluated.~   "
81092|NCT01995994|"~     To assess the accuracy, safety, and influence of sampling site of Real-time continuous~     glucose monitoring system (Medtronic Guardian).~   "
81093|NCT01995981|"~     This study is a phase IV post registration prospective observational feasibility study in~     patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for~     patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or~     ifosfamide.~        -  This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose~          fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker~          of pazopanib treatment effect in patients.~        -  It also studies pazopanib pharmacokinetics to see if there are differences between~          elderly and younger patients.~      The primary objectives are:~        -  To evaluate whether early metabolic response is correlated to clinical benefit.~        -  To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.~      The secondary objectives are:~        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib~          therapy) is correlated with pazopanib exposure.~        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib~          therapy) is correlated with the histological subtypes.~   "
81117|NCT01995669|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of GA101 (obinutuzumab) and lenalidomide that can be given to patients with~     indolent NHL. The study will also look at how well the two drugs work together to control~     the disease.~   "
81094|NCT01995968|"~     The main objective is to assess the role of antenatal detection of fetal growth restriction~     (FGR) on stillbirth, by a case-control study in a population-based sample of small for~     gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and~     Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of~     French customised birth weight curves.~      Our secondary objectives are~        -  to identify determinants of antenatal detection of FGR among a representative sample of~          SGA births, with a special interest in the definition of FGR. Our hypothesis is that~          births who are SGA by customised birthweight curves and non-SGA by population~          birthweight curves, are not detected antenatally, despite the current strategy~          including the use of umbilical Doppler.~        -  to analyse prenatal care of a subsample of SGA stillbirths with and without detection~          of FGR by a confidential enquiry.~   "
81095|NCT01995955|"~     The proposed study is to validate a new non-invasive imaging technique for evaluation of~     cardiac microciculation in coronary artery disease with a comparison with validated~     technique invasive, which is measure of index of myocardial resistance.~   "
81096|NCT01995942|"~     Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins~     around the tumour. Rectal cancer treatment has improved greatly over recent years. However,~     it is important for us to learn as much about the tumours as possible in order to develop~     newer therapies. Current treatments may benefit from new genetic information relating to the~     cancer. We hope to identify genetic differences in certain types of rectal cancer which will~     allow future treatments.~   "
81097|NCT01995929|"~     The esophago-gastro-duodenoscopy is an endoscopic examination technique of the upper~     GI-tract which was founded by the German surgeon Johann Freiherr von Mikuliicz-Radecki at~     the end of 19th century. By this means, the luminal site of the esophagus, stomach and~     duodenum may be visualized after inserting a flexible endoscope through the mouth (transoral~     access). By the rapid technical development in the last years smaller flexible video~     endoscopes have been developed allowing also an alternative access to the upper GI-tract via~     the nose (transnasal access).~      Patients with dysphagia are referred to physicians of different disciplines~     (gastroenterology, surgery, ear, nose, and throat (ENT) medicine, radiology, neurology)~     performing a variety of endoscopic and non-endoscopic techniques. Mostly, the endoscopic~     examination of the esophagus is done in sedated patients in left lateral examination.~     Typical findings during esophagoscopy might be tumors, strictures, achalasia or diverticula.~      Patients suffering from neurogenic dysphagia often get caught in the trap: they find~     themselves somewhere in the space between gastroenterologist, neurologist, ENT-specialist~     and radiologist. This dilemma might be due to a lack of pathophysiological knowledge among~     many physicians and an inability to directly visualize the esophageal phase of deglutition.~     In sedated patients lying in left lateral position, endoscopists may receive a very limited~     impression of the function of the different phases of swallowing since this endoscopic~     access is a rather static one.~      The focus of our observational study are patients with suspected neurogenic dysphagia. These~     patients shall be examined by transnasal endoscopy applying an ultrathin video endoscope~     with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe). Patients are examined in~     sitting position while ingesting water and food of different consistencies (functional~     endoscopy). Diagnostic shall be completed and correlated by videofluoroscopy,~     high-resolution manometry and assessment of the clinical signs. Beside feasibility and~     safety as primary endpoints, secondary endpoints shall be the assessment of pathologic~     endoscopic findings in patients suffering from neurogenic dysphagia. The study is approved~     by the local Ethics Committee (AZ 2010-214-f-S).~   "
81098|NCT01995916|"~     This study has been funded by National Institute of Mental Health (NIMH) to compare two~     behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric~     disorder (PMDD). Both of these interventions will be run in a group format, meaning that you~     will be part of a group of other women who have a menstrual mood disorder. Both of these~     interventions will be run by experienced mental health professionals and both interventions~     have been shown to be effective in reducing mood symptoms, increasing a sense of well-being,~     and helping individuals cope with stress. While it is expected that both interventions to be~     associated with some benefit, this study is designed to see which is better for women with a~     menstrual mood disorder.~   "
81099|NCT01995903|"~     To combine several brain imaging techniques to develop a new diagnostic test to help with~     earlier diagnosis of amyotrophic lateral sclerosis.~   "
81100|NCT01995890|"~     The Nevanac product information insert says that it can cause increase in eye pressure in~     5-10% of patients. There is very little published literature on the effect of topical~     Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report~     this effect with a working hypothesis that there is no increase in eye pressure following~     use of Nepafenac eye drops.~   "
81101|NCT01995877|"~     To determine if laying down or standing up changes the diameter of the inferior vena cava.~   "
81102|NCT01995864|"~     The study represents the research component of a broader initiative entitled RedeAmericas.~     RedeAmericas (RA) is a collaborative effort of investigators from six cities across Latin~     America (Buenos Aires, Cordoba, Medellin, Neuquen, Rio de Janeiro, and Santiago) and~     Columbia University in New York.~      This is a pilot Randomized Controlled Trial (RCT) of Critical Time Intervention—Task~     Shifting (CTI-TS). It is designed to address a fundamental gap in the services offered by~     mental health clinics. These clinics are the primary locale for outpatient treatment of~     individuals with severe mental disorders in the urban areas of Latin America, and they offer~     some basic and important clinical care such as pharmacologic treatment onsite. Generally~     these clinics also have a major limitation; they have inadequate resources and training for~     the provision of in vivo community-based services, that is, services delivered outside of~     the clinic facility in homes or elsewhere in the community. In most urban areas, they also~     have weak links to primary health care and are not easily accessible to much of the~     population.~      CTI-TS, is a task shifting intervention that at the service user level provides support for~     better community living and promotes social integration, and at the system level strengthens~     the connections between mental health and primary care clinics. CTI-TS is a time-limited~     9-month intervention provided at the critical time when a person is first offered services~     at a mental health clinic. During this period CTI-TS workers forge relationships that will~     shape the continuing use of services and enhance the potential for recovery over the~     subsequent course of time. The overall goal of CTI-TS is to improve the lives of those with~     severe mental disorders who receive community-based mental health care.~   "
81103|NCT01995851|"~     Overall, this study will determine (1) the effect of vaccine type (FluMist vs. TIV) on~     immunization rates, (2) assess the feasibility of school immunization clinics, and (3)~     inform a larger study to understand the effects of these two vaccines on reducing influenza.~   "
81104|NCT01995838|"~     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled,~     parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.~     Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or~     25 mg) or placebo.~   "
81105|NCT01995825|"~     In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in~     patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food~     and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and~     patients with epilepsy have believed that brand and generic lamotrigine have had clinically~     significant differences in efficacy and tolerability. The brand name and generic tablets~     have been shown to be the same when blood levels were measured in healthy volunteers without~     epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study~     will do this comparison, by switching patients between brand and generic in a very~     structured manner, and seeing if the drugs are the same, primarily in terms of blood levels.~     Other comparisons will also be made secondarily, looking for any differences in adverse~     effects and seizure control.~   "
81106|NCT01995812|"~     Physical activity is an important lifestyle modification for individuals with high blood~     pressure. It is part of national cardiac care guidelines for hypertension management that~     recommends, along with prescribing medication, lifestyle modification be promoted for~     improved dietary intake, and participation in about 150 minutes of moderate exercise a week.~     Native Hawaiians and other Pacific peoples (NHPP) have among the highest risk for the heart~     disease, with mortality rates twice other ethnic groups. In many minority populations,~     including NHPP, hypertension develops at an early age, is more severe and is less likely to~     be controlled. Despite the ability of physical activity to reduce blood pressure, the~     majority of U.S. population, do not meet physical activity recommendations and new~     interventions that can improve accessibility and adherence, particularly among at-risk~     minority populations are needed.~      In this research, Hypertension and Hula: Ola Hou Pilot Study, we plan to evaluate a~     culturally relevant intervention that uses hula and is consistent with the goals of~     recommended physical activity for improved lifestyle - moderate-intensity, prolonged~     physical activity cumulatively at about 150 minutes per week. Hula, the traditional dance~     form of Native Hawaiians, is commonly practiced in Hawai'i as a cultural practice, form of~     creative expression, and exercise that is structured on controlled, rhythmic movements.~     Combining aspects of meditation, music, self-awareness with low-impact aerobic exercise,~     traditional hula may be particularly suitable to individuals with limited mobility and~     fitness and within the recommended paradigm for exercise training and secondary prevention~     of coronary artery disease (CAD). We anticipate a hula and heart health education program~     will be particularly appealing to Native Hawaiians and other Pacific people (NHPP) including~     Pacific Islanders and Filipino who suffer from a significant disparity in cardiovascular~     health.~      Specifically, we will determine if individuals with poorly managed hypertension and~     randomized to a 12-week hula and heart health education intervention will demonstrate better~     blood pressure levels, functional capacity, and exercise tolerance (6-minute walk test) than~     individuals randomized to a usual care group. We will also assess if the individuals in the~     hula intervention report better health-related quality of life, stress management,~     perceptions of discrimination, and exercise self efficacy.~   "
81107|NCT01995799|"~     Ferumoxytol is an example of a 'smart' magnetic resonance contrast agent that consists of~     ultrasmall superparamagnetic particles of iron oxide (USPIOs) and is avidly taken up by~     macrophages. Through a previous work, the investigators have established that USPIOs can~     identify inflammation in the wall of abdominal aortic aneurysms and that this is associated~     with a three-fold increase in the rate of aneurysm growth. The utility of ferumoxytol for~     imaging cardiovascular inflammation in other areas of the body has yet to be established but~     Dr Alam has established uptake of USPIOs in the penumbra and infarct zone of the myocardium~     in patients with a recent myocardial infarction. The investigators wish to assess USPIO~     uptake in patients with recent acute myocardial infarction and identify the time course and~     determinants of cellular tissue inflammation. This will be the first clinical study to~     examine the ability of USPIOs to image myocardial inflammation following acute myocardial~     infarction.~   "
81108|NCT01995786|"~     The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid~     Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using~     automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been~     developed to perform clinical and expenditures data collection, both retrospective and~     prospective data are archived.~   "
81109|NCT01995773|"~     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women.~     Women with PCOS often have problems with fertility, unwanted hair growth, and irregular~     menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low~     quality of life.~      In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen~     levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition,~     pfysical activity and quality of life is studied in 40 healthy women. The results will be~     compared with results from studies on women with PCOS in order to investigate any~     differences in these parametres.~   "
81110|NCT01995760|"~     The purpose of this study is to evaluate which is the most appropriate parameter correlates~     with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.~   "
81111|NCT01995747|"~     Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial~     fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was~     approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may~     not be effective for patients with much higher serum IgE levels, such as those with atopic~     dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly~     and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX~     mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including~     IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to~     activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B~     lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by~     anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in~     a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state~     in allergic patients.~   "
81112|NCT01995734|"~     The present study is planned as an expanded treatment protocol to provide acromegalic~     patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory~     approval for pasireotide is sought.~   "
81113|NCT01995721|"~     Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life~     threatening condition resulting in surgical interventions. The maturing and disintegrating~     papillomas are the sources for the subsequent HPV relapses and immunization might slow down~     or even prevent this ongoing process.~      After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3~     relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to~     the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT~     examinations to assess response to vaccination.~   "
81201|NCT01994577|"~     Blood tests may be able to quickly identify and exclude patients that are having a heart~     attack. Using these tests in the Emergency Department (ED) may lead to faster treatment, a~     reduced wait time, and quicker discharge for patients presenting with symptoms suggestive of~     a heart attack.~   "
81118|NCT01995656|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3108743 in healthy participants and in participants with type 2 diabetes.~      The study will also investigate how LY3108743 affects the levels of blood sugar and other~     naturally occurring substances (e.g. hormones that control the way sugar is used) in the~     body, how much of the study drug gets into the blood stream, and how long it takes the body~     to get rid of it.~      Information about any side effects that may occur will be collected. The study is expected~     to last approximately 7 to 8 weeks for each participant.~      The study will have up to 3 parts. Participants may enroll in only one part.~   "
81119|NCT01995643|"~     The proposed study aims to investigate that consumption of grape seed extract (GSE) would~     improve antioxidant status and impaired insulin action following consumption of a~     pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.~   "
81120|NCT01995630|"~     The purpose of this study is to evaluate differences in the depth of focus after~     implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After~     implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus~     compared to emmetropic patients due to a larger amount of spherical aberrations.~   "
81121|NCT01995617|"~     GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a~     randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male~     and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized~     in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo,~     respectively. Each subject will receive up to 3 doses at 4 week intervals.~      Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after~     their last dose.~   "
81122|NCT01995604|"~     The purpose of this study is to evaluate the efficacy of dHACM (Dehydrated Human Amnion~     Chorion Membrane) for reducing time to healing when used in post-laser recovery following~     ActiveFX™ and DeepFx™ fractionated ablative CO2 laser resurfacing of the face.~   "
81123|NCT01995591|"~     Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine~     Green injections around the tumour in pieces of colectomy from patients with colon cancer.~   "
81124|NCT01995578|"~     The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the~     disease coming back after a stem cell transplant in patients with MDS and AML. This study~     will also be looking at the side effects of this medicine.~      5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients~     whose disease came back after transplant, where it helped going into remission. It is~     unclear if 5'-Azacitidine can prevent the disease from coming back after transplant. This~     study will help show if getting 5'-Azacitidine soon after transplant can lower the risk of~     your disease coming back.~   "
81125|NCT01995565|"~     This prospective investigation studies changes in regional cerebral hemodynamics and~     oxygenation as a function of cardiac output and blood pressure in intensive care patients.~   "
81126|NCT01995552|"~     The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%)~     patients in the acute phase (at discharge from hospital after index MI) and chronic phase~     (at 8-10 weeks after index MI) and to correlate with patients at high risk of all-cause~     mortality or sudden cardiac death (SCD) at 1 year.~   "
81127|NCT01995539|"~     The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose~     Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating~     patients in India with type 2 diabetes to get a better understanding of their patient's~     metabolic fluctuations, and support appropriate therapeutic intervention.~   "
81128|NCT01995526|"~     The main purpose of this study is to evaluate how the body processes the study drug known as~     insulin peglispro and how the study drug affects blood sugar in healthy male Japanese~     participants. This study will also evaluate safety of the study drug. The study will last up~     to 46 days for each participant, not including screening.~   "
81129|NCT01995513|"~     The purpose of this study is to determine if continued treatment with Enzalutamide is~     effective in patients with metastatic prostate cancer.~   "
81130|NCT01995500|"~     The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR~     Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison~     to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).~      The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary~     endpoint of angiographic in-stent late loss at 6 months.~   "
81131|NCT01995487|"~     The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to~     the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion~     failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary~     endpoint of angiographic in-stent late loss at 13 months; and that it is more~     cost-effective.~   "
81132|NCT01995474|"~     Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and~     staging of pancreatic cancer. One potential limitation is contamination when needle~     traverses the gastrointestinal tract under continuous negative pressure. Gastrointestinal~     tract contamination can lead to misinterpretation of FNA specimens. We propose a technique~     to eliminate any remaining negative pressure during EUS-FNA and therefore decrease~     gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe~     from the biopsy channel after a specimen is obtained eliminates any remaining negative~     pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA~     specimens, and will lead to improved diagnostic accuracy of this important clinical~     technique.~   "
81145|NCT01995305|"~     Fanconi anemia is a rare autosomal or sex linked recessive genetic disease. The disease is~     characterized by bone marrow hematopoiesis failure, multiple congenital abnormalities, and~     susceptibility to neoplastic diseases. The cells of FA patients are extremely sensitive to~     MMC and DEB. The symptoms and ages of FA patients are different, so by comparing the exome~     of FA patients and their parents, the mutations that were accumulated in FA patients could~     be found, and these genes might be sensitive to repairment and be important for~     hematopoiesis maintainance.~   "
81146|NCT01995292|"~     The purpose of this study is to determine whether modified spray as you go technique using~     the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for~     the patient.~   "
81133|NCT01995461|"~     The most common forms of injection used for the treatment of degenerative lumbar spinal~     stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar~     epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid~     injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS,~     particularly in patients whose level of stenosis is L4-5 or higher. However, these~     unilateral injections do not cross the midline, so in cases of lower extremity pain and~     symptoms on both sides, a bilateral TESI would probably be more beneficial.~      To date, there have not been any well designed prospective studies to determine the~     effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC.~     Therefore, the goal of this prospective, non-randomized case-series outcome study is to~     evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving~     function in patients with DLSS. The hypothesis is that BTESI at the level below the most~     stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and~     improves function in patients with DLSS.~   "
81134|NCT01995448|"~     Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many~     clinical, hemodynamic and biological criteria which have a low sensitivity and specificity~     if they are considered separately. The extensive experimental data which have been published~     contrast with the hematological data collected by the physician at patient's bedside~     especially regarding neutrophils and platelets levels. When there is no obvious clinical~     sign, a biological tool reflecting the patient's immune status could be useful to understand~     the physiopathology of Sepsis and to predict the progression of the disease in the patient.~     On the long-term it could also help to define management strategies.~   "
81135|NCT01995435|"~     Correlating the accuracy of a refraction done over telemedicine to that of a standard~     refraction, with a study hypothesis that the results will be equivalent.~   "
81136|NCT01995422|"~     The main objective of this study is to evaluate the effect of a 12 weeks adapted physical~     activity program (active walking) on depression by analyzing the dynamics of emotional and~     cognitive functioning. The secondary objectives are to test the effects of a physical~     activity on functional performance and to highlight psychological mechanisms.~   "
81137|NCT01995409|"~     Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight~     and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to~     maternal smoking or contact with second-hand smoke.~      The purpose of this study is to test the feasibility of delivering and evaluating the~     effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women~     and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke.~     The intervention will be delivered through routine antenatal and postnatal healthcare~     settings provided by midwifery and health visiting services.~      The intervention consists of educational materials to be given to the woman and a~     conversation held between the woman and midwife/health visitor about protecting the baby~     from second-hand smoke. The development of the intervention has been informed by the views~     of health professionals and service users, incorporates behaviour change theory and has~     drawn on other SFH materials developed for other settings. Different parts of the~     intervention will be delivered at different points along the antenatal and postnatal care~     pathway. 200 pregnant women and their newborns will be recruited.~      We will measure salivary cotinine levels to assess the level of exposure to SHS in women and~     urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the~     delivery of the intervention to test the feasibility of delivering, and methods to evaluate~     the effectiveness of the intervention.~      Feasibility study outputs:~        -  A standardised, acceptable, feasible and appropriate health education intervention to~          protect unborn and newborn babies exposure to second-hand smoke at home, capable of~          being integrated into routine midwifery and health visiting practice~        -  A trial protocol to evaluate the effectiveness of the intervention on unborn and~          newborn babies' exposure to secondhand smoke.~   "
81138|NCT01995396|"~     In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal~     anastomoses is the gold standard. However, in patients with a weak sphincter and fecal~     incontinence or in patients with severe co-morbidity and reduced general condition, this~     operation is not suitable.~      In these situations there are two other radical surgical options, Hartmanns procedure and~     the Abdominoperineal excision that can be performed with intersphincteric dissection to~     minimise perineal complications.There are no data on which of these procedures that are best~     suited for these patients with fecal incontinence or severe co-morbidity( at risk for~     life-threatening anastomotic leak). In this randomized study we intend to compare~     postoperative complications within 30 days after these two procedures and also late~     complications and quality of life after one year postoperatively.~   "
81139|NCT01995383|"~     This single-center, randomized, placebo-controlled, double-blind study will assess the~     safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two~     parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to~     placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of~     RO6836191 or placebo under low or normal-salt diet conditions. A subset of these~     participants will subsequently receive a single IV dose of RO6836191 for further analysis.~   "
81140|NCT01995370|"~     To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol~     (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for~     secondary prevention of ischemic stroke in high-risk patients for stroke~   "
81141|NCT01995357|"~     The influence of the baseplate adhesive type, shape and application is investigated with~     regard to the degree of leakage.~   "
81142|NCT01995344|"~     This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating~     Lymphocytes (TIL) in metastatic melanoma patients given with preconditioning chemotherapy~     and Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which~     TIL will be derived, cultured and expanded. Patients will receive preconditioning~     chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine~     (25mg/m2) day -5 to day -1. The autologous TILs will be re-infused on day 0 and the patients~     will receive up to 12 doses of intravenous High Dose Interleukin-2 (HD-IL2) or Low Dose~     Interleukin-2 (LD-IL2) depending on the randomised arm.~      The primary objectives are response rate assessed and compared by CT scans carried out at~     week 6, week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and~     tolerability of TIL therapy with HD-IL2 versus LD-IL2.~   "
81143|NCT01995331|"~     Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors~     associated with life-threatening complications. High-dose cyclophosphamide has been found to~     yield a complete response (CR) in adults and children with SAA.However, the optimal dosage~     of cyclophosphamide for patients in childhood remains unclear. So we explore the ideal~     dosage of cyclophosphamide for the treatment of children with SAA.~   "
81144|NCT01995318|"~     Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in~     emergency department. It enhances Karlsson score more than elastic bandage.~   "
81147|NCT01995279|"~     The aim of the present project is to examine the effects of single session of French ear~     acupuncture on pain sensation and on postural control in individuals with chronic low back~     pain.~      We hypothesize that:~      I) The application of French ear acupuncture at specific points to reduce low back pain~     would decrease pain intensity in patients with chronic low back pain.~      II) The pain reduction would be greater for those individuals with low back pain who receive~     application of French ear acupuncture at specific points to reduce low back pain compared~     with patients who receive placebo treatment.~      III) The application of French ear acupuncture at specific points to reduce back pain will~     have positive effect on the performance of the postural control system.~   "
81148|NCT01995266|"~     Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon~     alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV)~     Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks~     post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen~   "
81149|NCT01995253|"~     The aim of this study was to find functions for estimating energy expenditure in free-living~     conditions. This method was based on accelerometry data acquired from a smartphone worn in a~     trouser pocket. The developed functions have been compared to the estimations provided by~     two research devices named Armband and Actiheart.~   "
81150|NCT01995240|"~     Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at~     an early stage. Preferably, these markers could be determined non-invasively and provide~     insight into the biology of pancreatic cancer. Several MR techniques can serve for this~     purpose. However, optimalisation of these techniques is needed and their reproducibility~     should be assessed.~   "
81151|NCT01995227|"~     The purpose of this study is to determine the safety and the immunological, radiological,~     and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients~     with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC~     treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized~     anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen~     prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two~     components provides a vaccine designed to bring out an immune response capable of finding~     and killing the tumor cells.~   "
81152|NCT01995214|"~     Delirium is defined as an acute onset and fluctuating course of mental status change with~     inattention and an altered level of consciousness. Delirium in the postoperative period can~     be divided into emergence delirium and postoperative delirium, based on the time of onset~     (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious~     problem affecting the safety of patients and medical personnel. Clinical studies~     demonstrated that postoperative delirium is associated with worse outcomes such as prolonged~     hospital stay, postdischarge institutionalization, and increased mortality (Ely et al.,~     2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the~     development of postoperative delirium, including patient's medical condition, administration~     of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005;~     Robinson & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been~     reported to be associated with more emergence delirium in pediatric patients, when compared~     with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric~     patients on postoperative delirium, when compared with sevoflurane anesthesia. We~     hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50%~     when compared with sevoflurane anesthesia.~   "
81153|NCT01995201|"~     This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously~     administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with~     methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and~     an inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients~     will receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or~     without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve~     sustained clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive~     RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or~     without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained~     clinical remission but achieve low disease activity (DAS-ESR </= 3.2) will continue the~     initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without~     methotrexate or other non-biologic DMARDs.~   "
81154|NCT01995188|"~     This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics~     of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous~     Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused~     DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The~     combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab~     [Avastin] in three dose expansion cohorts.~   "
81155|NCT01995175|"~     The purpose of this study is to assess the incidence and associated healthcare utilization~     of RSV-associated, suspected LRTI in a general population of infants from birth up to 2~     years of age, and also to assess the accuracy of a newly developed LRTI case definition and~     severity scale compared to two existing definitions.~   "
81156|NCT01995162|"~     The aim of this study was to validate functions for estimating energy expenditure in~     free-living conditions. This method was based on accelerometry data acquired from a~     smartphone worn in a trouser pocket. The developed functions have been compared to the~     estimations provided by two research devices named Armband and Actiheart.~   "
81171|NCT01994967|"~     Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose~     of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in~     spinal anesthesia.~   "
81222|NCT01994291|"~     The study hypothesis under test is that administration of the CCR2/5 antagonist has the~     potential to be as effective as the current treatment options for subjects with diabetic~     macular edema. The current treatment option for these subjects is an injection directly into~     the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be~     just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and~     might be able to provide an alternative mechanism to treat Diabetic Macular Edema.~   "
81157|NCT01995149|"~     Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias~     and overweight or obesity and its effect on cholesterol metabolism has not been studied.~      Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism,~     by measuring circulating non-cholesterol sterols, in overweight or obese subjects with~     genetic hypercholesterolemias.~      Design: The investigators conducted a 6-months weight loss intervention in subjects with the~     diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL),~     body mass index >25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid~     lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with~     a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated~     from the person's resting energy expenditure and activity level. Anthropometric data,~     biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were~     evaluated at baseline, 3 months and 6 months.~   "
81158|NCT01995136|"~     The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004%~     ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.~   "
81159|NCT01995123|"~     The purpose of this study is to examine whether behavioral activation as an adjuvant to~     standard smoking cessation treatment improves smoking cessation outcomes among veterans with~     PTSD relative to a comparably intense combination of standard smoking cessation treatment +~     health and smoking education. It is expected that behavioral activation will produce more~     successful results than health and smoking education when paired with standard smoking~     cessation treatment.~   "
81160|NCT01995110|"~     The study will quantitatively evaluate the metabolic response of normal weight and obese~     subjects to three high-fat meals differing in caloric dose by analysing the postprandial~     blood transcriptome.~   "
81161|NCT01995097|"~     Primary Aim: To test the efficacy of a SMS text-based scheduled gradual reduction (SGR) and~     counseling intervention to promote smoking cessation in the late third trimester.~      Hypothesis: The rate of smoking cessation in the late third trimester among women in the SGR~     Support Messages arm will be higher than among women in the Support Messages arm.~      Secondary Aim 1: To assess the effect of the SGR intervention on biochemically validated~     prolonged abstinence and smoking reduction during pregnancy.~      Secondary Aim 2: To assess the effect of the SGR intervention on smoking abstinence at three~     months postpartum.~      Secondary Aim 3: To assess the effect of the SGR intervention on the rate of preterm birth.~   "
81162|NCT01995084|"~     Several studies have shown that tumour hypoxia may have a negative impact on the outcome of~     anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of~     treatment may serve as a predictive marker to determine treatment efficacy at an early~     stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive~     imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside~     analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-~     yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before~     hypoxia-measurements can be clinically implemented for response prediction, the~     reproducibility of the technique should be assessed for each specific tumor type. Knowledge~     of reproducibility is needed to determine what change in parameters between two examinations~     can be considered relevant in an individual patient. Assessment of reproducibility becomes~     even more important in early response monitoring since the changes in the tumor induced by~     the treatment may be smaller during the treatment compared to response monitoring after~     completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing~     time intervals after injection, determination of the optimal time point for measurement of~     hypoxia is warranted.~   "
81163|NCT01995071|"~     The purpose of this study is to evaluate the safety and antiviral effect of multiple doses~     of ABT-493 and ABT-530 in adults with genotype 1 HCV.~   "
81164|NCT01995058|"~     This study is designed to evaluate the safety and efficacy of combining abiraterone (with~     prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic~     castration-resistant prostate cancer (CRPC).~   "
81165|NCT01995045|"~     The aim of this study is to evaluate if patients receiving a steroid (triamcinolone~     acetonide) combined with local anesthesia and antibiotic following retina surgery have~     better postoperative pain control those receiving local anesthesia and antibiotic alone.~   "
81166|NCT01995032|"~     The purpose of the study is to show that the intake of L-citrulline and metformin improves~     muscle function and delay of progression in patients with Duchenne's muscular dystrophy.~   "
81167|NCT01995019|"~     The hypothesis is that a single dose intra-articular injection of corticosteroids are~     effective in relieving temporomandibular arthralgia pain.~      The purpose of the study is therefore to evaluate the effect of a single dose~     intra-articular methylprednisolone vs. placebo in a month perspective on subjects with~     unilateral arthralgia of the TMJ.~   "
81168|NCT01995006|"~     The planned study is a single-center, randomized, open-label parallel group study in 16~     healthy male subjects. Study subjects will be randomly allocated either to the metamizole~     group (1) or to the naproxen group (2). All participants will start with a low sodium diet~     (approximately 50 mmol Na+ per day) 7 days before the first drug intake and maintain the~     diet until the end of the study (14 days in total). Salt-depletion is an accepted model to~     enhance production of vasodilatory prostaglandins and to increase renal sensitivity to~     prostaglandin inhibition. On the first day of treatment (Day 1), a single dose of metamizole~     or naproxen will be administered to investigate the effects after a single dose and to~     collect single dose pharmacokinetic profiles. Starting on Day 2, all participants will~     receive therapeutic doses, i.e. 1000 mg metamizole 'ter in die' (TID, three times a day) or~     500 mg naproxen 'bis in die' (BID, twice a day) for one week and on Day 7 pharmacokinetics~     and pharmacodynamics effects will be assessed under near steady-state conditions.~      The primary objective is the characterization of the renal effects of metamizole by~     determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary~     objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and~     the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the~     urinary excretion of sodium and potassium.~      Overall, clinical experience suggests better renal tolerability of metamizole possibly due~     to less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs~     (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for~     treatment of painful conditions in patients with impaired renal function. Therefore, the aim~     of this study is to examine the effects of metamizole on renal function in comparison with~     the non-specific COX-inhibitor naproxen.~   "
81169|NCT01994993|"~     The main purpose of this study is evaluate whether it is safe or not to use various~     combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam,~     gentamicin) in treating infants with complicated intra-abdominal infections~   "
81170|NCT01994980|"~     Hypothesis: 4 days of antibiotic therapy, as compared to 8 days, is equally effective and~     results in decreased antibiotic exposure among surgical ICU patients with early VAP.~   "
81172|NCT01994954|"~     The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not~     increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair~     growth compared to standard oxygen management protocols.~      Evidence-based specific consensus guidelines for home regulated oxygen management do not~     currently exist. Current strategies for infants requiring outpatient supplemental home~     oxygen include brief checks of oxygen status during monthly clinic visits. Although the~     infants stay on monitors, no data in between visits is obtained to ensure that infants can~     maintain oxygen levels after weans are made. Before finally allowing oxygen to be removed,~     many centers also require an overnight sleep study in the hospital, to make sure that the~     infant's oxygen levels stay safe when the infant is in deep sleep. Because these methods~     rely solely on assumptions rather than individually recorded data, an infant's time on~     supplemental oxygen may be prolonged or insufficient. This study will evaluate both the~     currently used accepted therapy and a method of weaning that involves recording and sending~     oxygen data for analysis in between clinic visits.~      Premature infants who require home oxygen therapy at time of discharge who meet eligibility~     criteria will be randomized into two arms:~      Arm A (Standard therapy): Infants' oxygen will be increased, decreased, or maintained~     based on brief structured assessments during monthly clinic visits.~      Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments~     as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase,~     decrease or maintain oxygen between monthly visits.~      Parents of all infants will be interviewed using structured quality-of-life questionnaires~     at the beginning and ending of the oxygen management process. Health care utilization~     (emergency department visits and rehospitalizations) and growth will be assessed 6 months~     after discontinuation of oxygen.~      The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can~     improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and~     eliminate need for polysomnogram, without compromising safety. The investigators will~     determine respiratory-related re-hospitalizations, emergency department (ED) visits, and~     growth parameters to confirm safety of the proposed weaning strategies.~   "
81173|NCT01994941|"~     This study aims to compare the outcome between genotype guided versus clinical guided~     approach in selection of oral P2Y12 receptor blocker in Chinese patients suffering from~     acute coronary syndrome.~   "
81174|NCT01994928|"~     Preoxygenation is routinely performed before endotracheal intubation. In the intensive care~     unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that~     high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic~     respiratory failure, is equally effective in preventing the development of hypoxemia during~     intubation. In this prospective randomized study preoxygenation using high flow nasal~     cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with~     hypoxemic respiratory failure.~   "
81175|NCT01994915|"~     Chronic obstructive pulmonary disease is a chronic condition involving an impairment in~     functionality and in the execution of activities of daily life. The hypothesis of this study~     is that an occupational therapy intervention added to a physiotherapy program and a medical~     treatment increase the functionality and the quality of life of patients with chronic~     obstructive pulmonary disease.~   "
81176|NCT01994902|"~     The aim of the investigation was to investigate the performance and safety of a new ostomy~     product.~   "
81177|NCT01994889|"~     This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily~     dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with~     either transthyretin genetic variants or wild-type transthyretin resulting in amyloid~     cardiomyopathy.~   "
81178|NCT01994876|"~     To investigate the performance and safety of two newly developed convex 1-piece ostomy~     appliances~   "
81179|NCT01994863|"~     The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse)~     in reducing leakage (4-point scale) compared to Standard of Care.~   "
81180|NCT01994850|"~     This is a Phase I/II multicenter single arm non-randomized open label study of the~     investigational drug, brentuximab vedotin, given in combination with routine chemotherapy~     (rituximab, cyclophosphamide, doxorubicin and prednisone) every 3 weeks for a total of 6~     cycles.~   "
81181|NCT01994837|"~     A Phase 2, Open-Label, Multicenter study evaluating the preliminary efficacy and safety of~     ABT-199 administered orally in patients with AML.~   "
81182|NCT01994824|"~     Graft-vs-host disease (GVHD) causes substantial mortality, morbidity and poor quality of~     life after blood or marrow transplantation (BMT). In Alberta, we use antithymocyte globulin~     (ATG, given on days -2, -1 and 0) in addition to methotrexate and cyclosporine for GVHD~     prophylaxis. In spite of that, ~40% patients develop significant GVHD (grade 2-4 acute GVHD~     or chronic GVHD needing systemic immunosuppressive therapy). ATG at the dose we typically~     use (4.5 mg/kg) is relatively non-toxic. At higher doses, ATG could increase the likelihood~     of posttransplant infections or relapse. Thus an extra dose of ATG (on top of the routine~     4.5 mg/kg) might be justified only for patients at high risk of developing significant GVHD.~     In our experience, low serum level of interleukin-15 (IL15) and high serum level of~     interleukin-2 receptor alpha (IL2Ra) on day 7 predict development of significant GVHD. Here~     we will test whether, compared to historical/concurrent controls, an extra dose of ATG (3~     mg/kg on day 8) given to patients with low IL15 or high IL2Ra on day 7 reduces the incidence~     of significant GVHD, and improves survival free of relapse and GVHD, and quality of life.~   "
81183|NCT01994811|"~     The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research~     study that examines the lifestyles, eating habits, and health behaviors associated with~     cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.~   "
81184|NCT01994798|"~     This registry is designed to assess the clinically relevant benefits of balloon angioplasty~     and stenting in superficial femoral and popliteal artery, using rapid exchange technology.~   "
81185|NCT01994785|"~     This study will provide capnography monitoring during routine upper endoscopy and~     colonoscopy with moderate sedation in order to see if it improves safety.~   "
81198|NCT01994616|"~     This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids~     and hypertrophic scars in a large population of mixed Fitzpatrick skin types.~   "
81199|NCT01994603|"~     This trial will pilot test intervention strategies to increase utilization of HIV testing~     and gain knowledge for designing a clinical trial to evaluate prevention strategies to~     reduce HIV sexual transmission in the general population in Russia. The study will assess~     whether external (cost, convenience) or internal factors (low perception of own risk,~     reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's~     reluctance to be tested and if peer support impacts their decision. A randomized~     experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed~     by focus group discussions, followed by a second-chance testing offer will be used to inform~     these questions. The answers will enable the international research team to engineer and~     then test an HIV testing promotion strategy in Russia. The project will collect preliminary~     data for a larger study to develop an evidence-based program to reduce the HIV transmission~     in this high risk population.~   "
81186|NCT01994772|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible~     for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality~     of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to~     the initial cardiac rhythm present during the initiation of resuscitation. Recent progress~     in the improvement of mortality and neurological outcome has been achieved over the last~     decade thanks to the systematic implementation of a period of targeted temperature control~     between 32 and 34 ° C in patients who benefited from the realization of at least one~     electrical external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period~     of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~   "
81187|NCT01994759|"~     The purpose of this study is to determine whether reduced load to patients with plantar~     fasciitis (reduced standing, walking, landing) together with either controlled heavy~     resistance training or glucocorticosteroid injection or a combination thereof is the best~     treatment.~   "
81188|NCT01994746|"~     The primary objective of this study is to assess the effectiveness and safety of 3 mg~     glucagon (AMG504-1) administered as a puff into the nose compared with~     commercially-available glucagon given by injection.~   "
81189|NCT01994733|"~     Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels~     have significantly higher mortality rates compared to those with normal P. In patients~     receiving conventional dialysis regimens, serum P may be lowered through dietary~     intervention and use of P binders, though these have potentially important side effects and~     may adversely impact quality of life. Whether lowering P, and / or targeting specific P~     levels improve survival and clinical outcomes is unknown. Despite this uncertainty, over 90%~     of patients with ESRD receive P lowering therapy and guidelines for the care of patients~     with ESRD are increasingly calling for more aggressive phosphate lowering. This intensive P~     lowering results in extra medications (and their associated side-effects), and higher health~     care costs. We are uncertain whether the intensification of P control results in measurable~     benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the~     feasibility of conducting a randomized controlled trial of intensive vs liberalized~     phosphate control among hemodialysis recipients.~   "
81190|NCT01994720|"~     The primary objective of the study is to compare the effect of 90-day treatment with~     ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily~     maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300~     mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance~     dose for the remainder of the study) for the prevention of major vascular events (composite~     of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or~     transient ischaemic attack (TIA).~   "
81191|NCT01994707|"~     The investigators aim to definitively show if human myocardium can be remotely~     preconditioned. In the writings there are no experiments that would prove that the remote~     preconditioning protocol effects on the higher protection of the human myocardial cells,~     against the ischemia-reperfusion injury.~      120 patients referred for coronary artery bypass grafting (CABG) procedure with use of~     cardiopulmonary bypass are planned will be included to the research. Patients will be~     randomized (1:1) to one of two groups: remote preconditioning or placebo intervention. On~     the day of surgery, after induction of anesthesia remote preconditioning will be elicited by~     3 cycles of 5min inflation (ischemia) and 5 min deflation (reperfusion) of blood pressure~     cuff on the right arm. In the control group the blood pressure cuff is going to be placed on~     the upper limb but the preconditioning protocol will not be carried out. On cannulation for~     CPB, right atrial appendage and myocardial biopsies of the left ventricular will be~     harvested. The investigators will study: (1) resistance of myocardium to hypoxia/reperfusion~     injury in in vitro experiments, assessed in isolated right atrial pectinate muscle~     trabeculae (2) induction of apoptosis and status of mitochondria in myocardium after the~     period of ischemia, and reperfusion in vitro (3) amount of myocardial necrosis in-vivo~     induced by period of ischemia and reperfusion during CABG as assessed by postoperative~     myocardial necrosis markers release (4) the systolic function of the myocardium at the~     postoperative and the kidney function in the postoperative period evaluated by the~     creatinine clearance; (5) induction of apoptosis and status of mitochondria in myocardium~     after the period of ischemia, and reperfusion during coronary artery bypass grafting,~     assessed in myocardial.~      There is going to be an ability to define does the remote preconditioning influence on the~     occurrence of apoptosis in the human myocardium in the in vivo conditions and does it~     influence on the postoperative course in patients undergoing cardiac surgery procedures. The~     investigators will try to study if remote preconditioning modify induction of apoptosis and~     its structure in response to injury. In case the effect of remote preconditioning is not~     measurable in ex-vivo assessment, the future attempt at implementing this phenomenon in~     clinical practice may be futile and should not be continued until the effect can be~     confirmed in controlled experimental setting.~   "
81192|NCT01994694|"~     People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse~     and gambling. Current behavioral economy theories differentiate between risk perception and~     risk attitude. This study aims to measure both risk taking and risk perception in adults~     with and without ADHD. It is hypothesized that people with ADHD show decreased risk~     perception, accounting for their risky behavior. In contrast, it is hypothesized that people~     with ADHD do not show increased risk attitude, namely, they are not risk seeking.~   "
81193|NCT01994681|"~     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the~     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software~     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the~     best discrimination between Pancreatic Cancer sick population and healthy population. The~     gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.~   "
81194|NCT01994668|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg~     lorazepam intravenous administration in healthy Japanese adult subjects.~   "
81195|NCT01994655|"~     Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.~   "
81196|NCT01994642|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the~     already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic~     suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent~     tympanostomy tubes.~   "
81197|NCT01994629|"~     Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross~     reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old~     healthy toddlers.~   "
81202|NCT01994564|"~     Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons~     (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter~     the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual~     field defects at certain locations. Furthermore, the retinal nerve fiber layers from~     different receptors for different colors are ordered in a special manner as well. Thus, it~     is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).~      At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or~     only in end-stage glaucoma.~      By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma~     and in different stages of the disease will be investigated.~   "
81203|NCT01994538|"~     This study will investigate the treatment of urinary tract infection in men. Specifically,~     the investigators are looking to see if shorter duration of antibiotics (7 days) is any~     worse than longer duration of antibiotics (14 days). The investigators will also study~     whether longer treatment leads to an increase in antibiotic resistant bacteria in the large~     intestine (colon), or an increase in drug side effects.~   "
81204|NCT01994525|"~     This study is to assess the safety, tolerability, and biomarkers of protection in healthy~     malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either~     infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected~     (mock-immunization).~   "
81205|NCT01994512|"~     A national randomized multicentre trial (RCT) where decompression is compared with~     decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two~     adjacent lumbar levels with or without degenerative olisthesis. The material is stratified~     for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical~     results from patient surveys after 2 and five years, and with radiological follow-up (MRI,~     CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The~     null hypothesis is that there is no difference in results between the two interventions.~   "
81206|NCT01994499|"~     Infectious pleural effusion is a classic complication of pneumonia and often require pleural~     drainage.~      There is no consensus between surgical drainage and medical drainage indication in first~     intention to treat an empyema.~      Usually surgery is proposed in second intention after failure of medical drainage.~      Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The~     morbidity of this approach is very low with good results and become the gold standard in~     different pleural diseases. The medical drainage can be also very efficient but its results~     depends of the evolution of the pleural effusion. The rate of failure is estimated around~     25%.~      Then, the aim of our study is to compare surgical drainage and medical drainage in first~     intention. The first end-point will be the hospital stay (day). Hospital discharge will be~     strict, following different objective criteria of healing allowing comparison between these~     two approaches of drainage.~      To answer this question we will randomized 50 patients in 2 years with a multicenter~     recruitment.~   "
81207|NCT01994486|"~     This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with~     genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in~     combination with sofosbuvir (SOF) for 12 weeks.~   "
81208|NCT01994473|"~     This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its~     metabolite SEP-363854 in male and female subjects with schizophrenia.~   "
81209|NCT01994460|"~     The current standard short-course treatment for pulmonary TB requires 6 months to complete.~     This long duration of treatment increases the likelihood of side effects while decreasing~     patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against~     refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as~     well as the possible adverse effects of its long-term use, it is rational to use linezolid~     instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB.~     Through randomized controlled trial, the investigators will evaluate the hypothesis that the~     use of linezolid instead of ethambutol will increase the sputum culture conversion rate by~     15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be~     randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2~     (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of~     ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of~     treatment (liquid media).~   "
81210|NCT01994447|"~     Project Summary: One of the challenges facing pediatric researchers is the need to balance~     decreasing funding with the time and human resource costs associated with enrolling~     children. In order to address this, the Emergency Department (ED) research team developed an~     innovative model for subject enrollment and consent using highly trained and supervised~     undergraduate students. From a human resources perspective, utilizing students is more cost~     effective than the traditional research nurse model. However, a concern with this method is~     the adequacy of parental understanding of study information for informed consent. The aim of~     this project is to determine if the use of students is at least as good as the more costly~     gold standard of experienced research nurses. The validation of this innovative student~     model will enable child health investigators to better meet parent's needs and increase the~     efficiency of pediatric research.~      The primary objective of this study is to measure parental comprehension of informed consent~     information using an innovative undergraduate research assistant program compared to consent~     using the traditional research nurse model. We hypothesize that parental comprehension of~     the informed consent information process when approached by undergraduate students will be~     comparable (or not worse) than when consent is obtained by a research nurse.~   "
81211|NCT01994434|"~     Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes~     of this study are to report a series of 9 patients with pure ulnar nerve deep branch~     compression by a ganglion and to evaluate the outcome following a surgical treatment.~     According modified Bishop's scoring system, the investigators would evaluate postoperative~     results of this uncommon nerve lesion.~   "
81223|NCT01994278|"~     The aim of this study is to observe whether a brushless cleaning device can be equally as~     effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people~     an alternative to bristle brush cleaning if they find they are brushing too hard. The~     hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless~     methods in conjunction with flossing.~   "
81212|NCT01994421|"~     Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr~     Kenso Kase for prevention and treatment of sports injuries. Research shows that through~     activation of skin receptors KT improves blood and lymph flow, increases proprioception,~     helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function.~     Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its~     effectiveness in improving strength.~      Purpose: The purpose of the current study was to investigate the short-term effects of KT on~     muscle strength when applied to the quadriceps muscles of healthy subjects.~      Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were~     tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting~     Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four~     different sessions. The parameters of interest were: quadriceps and hamstrings maximal~     strength and power using vertical jump tests (squat jump and countermovement jump), and peak~     concentric and eccentric knee torque (using isokinetic test protocol).~   "
81213|NCT01994408|"~     High blood pressure leads to heart attacks and strokes which can be prevented by blood~     pressure-lowering medication. However, the current office-based prescription of one pill and~     one dose at a time is ineffective. the investigators want to pilot-test a more effective~     patient-centered treatment approach, where patients will receive a prescription with gradual~     but automatic weekly increases of dose and number of pills. Patients will measure their~     blood pressure with an iPhone compatible cuff, which transmits readings to the doctor or~     pharmacist, who will stop escalation when the desired blood pressure level is reached. The~     investigators hypothesize that the intervention will decrease the time to control blood~     pressure and increase the overall rate of blood pressure control. Therefore, this new~     treatment model could prevent heart attacks and strokes, and reduce healthcare costs.~   "
81214|NCT01994395|"~     Hypothesis/Specific Aims:~      The purpose of this study is to determine the effect of training with the Stride Management~     Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal~     drive to the lower limb muscles in patients post stroke. The investigators hypothesize that~     long-term SMA use would strengthen the connections between the motor areas of the brain and~     the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal~     excitability of the lower limb muscles compared to those in the IPT group.~   "
81215|NCT01994382|"~     This study will identify the highest dose, and assess the safety, of cerdulatinib~     (PRT062070) that may be given in patients with relapsed/refractory chronic lymphocytic~     leukemia or non-hodgkin lymphoma~   "
81216|NCT01994369|"~     Breast cancer is the most common cancer and the second cause of cancer mortality in women.~     There are approximately 200,000 new cases of breast cancer a year. Classically, breast~     cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment~     of both of these types is surgical resection not only for therapeutic purposes but also for~     diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and~     post-operative radiation. However, despite best surgical practices, when patients undergo~     BCT anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to~     increased rates of reoperation which are quoted to be as high as 30% and increased local~     recurrences.~      There is an over expression of folate receptors located on the surface of many human~     carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over~     express the folate receptor.~      Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate~     receptors over expressed in certain cancers such as breast cancer, and could help in better~     identifying the margins of the cancer thereby achieving negative margins.~   "
81217|NCT01994356|"~     As many as one-third of female healthcare providers use intrauterine contraception (IUC),~     but only about 8 percent of US women overall do. This begs the question: Might physician~     self-disclosure of personal IUC use increase IUC use among patients? However, the positive~     or negative impact of physician self disclosure on IUC uptake or patient satisfaction is~     generally unknown. The purpose of this study was to evaluate if physician self-disclosure of~     personal IUC use increases patient use of IUC or impacts patients' satisfaction with their~     clinical encounter.~   "
81218|NCT01994343|"~     Chronic pelvis pain is very common between adult women. Significant progress is made in~     clarifying the multifactorial model of chronic pain pathogenesis, but a more complete~     assessment is important in order to improve the therapeutic approach. The purpose of this~     study is stablish a clinical and symptomatological profile of women with chronic pelvic~     pain.~   "
81219|NCT01994330|"~     Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic~     stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena~     has received the name of Heye´s syndrome.~      We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve~     replacement surgery will reduce blood loss and transfusion rate.~      this was a pilot study~   "
81220|NCT01994317|"~     This study aims to compare an algorithm for IV sedation dosing to the current standard of~     care in patients undergoing first trimester surgical abortion. The primary outcome is~     subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes~     include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain~     ratings, incidents of side effects and adverse events, the frequency of additional doses of~     medication, recovery room time, and physician assessment of and satisfaction with pain~     control. Investigators hypothesize that this algorithm will result in improved pain control,~     decreased frequency of additional medication doses, improved patient and physician~     satisfaction, without differences in side effects, adverse events or recovery room time.~   "
81221|NCT01994304|"~     PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in~     preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental~     design with data collection from 34 facilities across six intervention districts and four~     control districts. The study with a sample of 137,000 births has 88% power to detect 15%~     reduction in intrapartum mortality. Data on this was collected over a period of 17 months~     (November 2013 to April 2015).~   "
81233|NCT01994148|"~     laparoscopy has been increasingly applied in patients with abdominal trauma , as an~     diagnostic and therapeutic modality. However, its clinical benefits are still under~     evaluation. The aim of this study is to prospectively assess the feasibility and safety of~     this technique in the management of traumatic gastrointestinal injury.~   "
81224|NCT01994265|"~     Cognitive and functional decline observed in atrial fibrillation (AF) patients are related~     to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in~     AF patients, despite effective, remains beyond desired levels because of interactions with~     food and fluctuations in blood levels. Because of a more stable anticoagulation state,~     Dabigatran may offer better protection against thrombotic phenomenon and, consequently,~     mitigate the process of cognitive and functional compromise.~   "
81225|NCT01994252|"~     Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are~     encountered with an increase in death and suffering. When both these two conditions occur in~     a patient, the patient's prognosis is poor with a reduced quality of life. These patients~     are frequently admitted to the hospital and have increased risk of death. In these HF~     patients who are in AF all of the time, who would otherwise be a suitable candidate for an~     implantable defibrillator to prevent sudden cardiac death, whether adding pacing of both~     ventricles will reduce death and suffering. Other studies have shown that adding pacing to~     both ventricles is of benefit in HF patients with mild to moderate symptoms and have a~     regular heart rhythm. The Investigators now want to explore if this therapy will benefit~     those patients with a permanent irregular heart rhythm (AF). The Investigators will also be~     assessing the cost effectiveness of this treatment strategy and the life quality for these~     patients. This study may have a dramatic impact on the way the Investigators manage these~     patients with atrial fibrillation and heart failure and may improve the outlook and well~     being of these patients.~   "
81226|NCT01994239|"~     The purpose of this study is to select the best therapeutic strategy in studying the~     effectiveness of the association of a short duration hormonal therapy and radiotherapy~     compared with radiotherapy alone, in patients with a detectable PSA after radical~     prostatectomy.~   "
81227|NCT01994226|"~     Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most~     patients are treated entirely in general practice yet primary care management is frequently~     suboptimal. Acute attacks of gout are excruciatingly painful and require urgent drug~     treatment to reduce inflammation, most commonly with antiinflammatory drugs(NSAIDs) or~     colchicine. In primary care, NSAIDs are most commonly used but can cause serious side~     effects such as stomach ulcers and heart disease, particularly in the elderly. Patients~     frequently require repeat prescriptions for recurrent attacks of acute gout increasing the~     risk of drug-related side-effects. Low-dose colchicine is popular amongst rheumatologists as~     it is effective and well tolerated. However, general practitioners (GPs) prescribe~     colchicine infrequently, probably because in the past the recommendation was for high doses~     to be prescribed which commonly caused severe diarrhoea. Recently, prescribing~     recommendations for colchicine have changed, advocating a lower dose regime.~      Currently there is no evidence regarding whether NSAIDs or low-dose colchicine is the best~     treatment for acute gout. This trial will be the first direct comparison of the~     effectiveness and side effects of a NSAID (naproxen) and low-dose colchicine to treat acute~     gout in primary care. Naproxen will be used in this trial because it has been shown to be as~     effective as oral prednisolone for the treatment of acute gout, is safer than other commonly~     used NSAIDs such as diclofenac and indomethacin, and is inexpensive.~      Patients consulting their GP with an acute attack of gout in up to 100 general practices~     will be invited to participate. Treatment success will be assessed by comparing pain~     reduction between the two drugs. The trial will also monitor side effects, quality of life,~     and cost effectiveness.~   "
81228|NCT01994213|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumor.~   "
81229|NCT01994200|"~     While thyroid cancer is generally associated with a favourable prognosis, there is a~     discrepancy with how important if not traumatic its impact can be on patients. Quality of~     life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an~     optimal period for a preventive intervention. The goal of this study is to evaluate the~     impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid~     cancer patients, including a dedicated nurse who will provide important psychoeducational~     elements identified in previous focus group studies of thyroid cancer patients, i.e.,~     information on: the physical illness; the emotional impact of being newly diagnosed with~     thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine~     treatments and its associated safety precautions, nutrition and dietary considerations; and~     how the cancer diagnosis can be an opportunity to make important lifestyle changes and~     establish new life-priorities.~   "
81230|NCT01994187|"~     Investigate the current situation of carotid stenosis therapy in China. Establish the data~     bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best~     quality control of the therapy, as well as confirm the standard treatment for carotid~     stenosis.~      Understand situation about the adverse events occurs after the revascularization (CAS and~     CEA), evaluate the health economics .~   "
81231|NCT01994174|"~     The objective of this research is to determine the effects of anti-VEGF drugs (bevacizumab,~     ranibizumab or aflibercept) on aqueous humor dynamics (AHD) in patients with retinal~     vascular disease. The underlying hypothesis is that anti-VEGF drugs increase intraocular~     pressure (IOP) by increasing aqueous inflow, decreasing uveoscleral outflow or both. The~     specific aim is to evaluate the changes produced in AHD after 3 monthly injections of anti~     VEGF agents.~   "
81232|NCT01994161|"~     This trial is an prospective, government-funded registration study that will observe the~     safety and effectiveness of intracranial stenting for preventing stroke during a mean~     follow-up of 12 months in patients with symptomatic stenosis of a major intracranial artery~     (MCA, carotid, vertebral, basilar). This trial will be launched by Xuanwu Hospital, Capital~     University of Medical Science, with 20 collaborators participating. Enrollment will begin in~     2013, and it aims to have a sample size of 840 subjects in 2 years. The trial is scheduled~     to complete in 2015.~      As we know, SAMMPRIS is flawed with defect in design, heterogeneity in experience and~     credentials of operators and high rate of complication; Whether the interventional therapy~     for symtomatic intracranial artery stenosis is effective or not remained resolved. This~     trial has been modified based on SAMMPRIS in order to acquire the data for China: Technique,~     experience, and credential of the operators are closely related with perioperative~     complications in PTAS. The investigators select 50 large-scale medical centers for~     participation on the basis of geographical distribution. All the participants are ranked as~     top in China. They have the most experienced surgeons or interventionist in China, and are~     fully qualified for this trial. This will guarantee the success and safety of technique,~     maintain the continuity of operator's experience, and make the complication rate as low as~     possible.~   "
87754|NCT01908712|"~     The overall objective of this trial is to provide aftercare treatment with Lamazym and to~     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis~     whom previously participated in Lamazym-trial.~   "
81234|NCT01994135|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose levels rise until it reaches a~     peak concentration usually after 30 minutes. When the body senses the increase in blood~     glucose, a hormonal process involving insulin takes place to ensure that the glucose is~     taken up from the blood for storage and where it is needed for energy in the body. This~     process then brings about a decrease in the concentration of glucose until it reaches~     approximately the starting concentration. The original concentration of glucose is attained~     approximately 2 hours after eating or drinking a carbohydrate food or sugary drink~     respectively.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.(1)~      Research has shown that diets that give rise to a high glucose response are associated with~     a number of abnormalities like increased metabolic syndrome (2). Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of~     type 2 diabetes. (3) It also gives rise to other conditions like high blood pressure~     (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts~     of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood~     (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular~     disease also rises. (4) Research has also shown that foods/drinks which raise blood glucose~     levels gradually (low GI) rather than rapidly (high GI) have health benefits which include~     reducing the risk of metabolic syndrome (5). In vitro studies have shown that polyphenols~     found in fruits, vegetables and plant based foods have a positive effect on carbohydrate~     metabolism and can lower the blood glucose levels. (6)~      This research will determine whether the presence of polyphenols in the diet has any~     lowering effect on the blood glucose levels and hence the glycaemic index of foods. This~     will be determined by asking volunteers to consume polyphenol rich drink/food together with~     white bread and determine the glycaemic response. The GI of bread will be determined~     initially as a reference.~      Analysis will be done by measuring blood glucose response to white bread alone as reference~     and then to white bread with test sample containing polyphenols and then determine GI and~     see how the GI of bread will be affected. Other analyses to be done are plasma insulin,~     glucagon, gastric inhibitory polypeptide (GIP) and glucagon like peptides-1 (GLP-1) as they~     all relate to glycaemic response.~      Study hypothesis is that glucose metabolism will be affected.~      NOTE:~        1. Only healthy participants undertook the study (Hence metabolic syndrome participants~          not part of the study)~        2. Only glucose and insulin were analysed in the plasma (hence GIP, GLP-1 and glucagon not~          part of end points)~   "
81235|NCT01994122|"~     The purpose of this study is to examine differences in selected psychiatric/psychological~     variables between a sample of unemployed young adults who have dropped out of high school~     and a sample of college students.~   "
81236|NCT01994109|"~     This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea~     (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected~     directly into the salivary glands. MYOBLOC has been shown in previous trials to safely~     decrease saliva production, thereby demonstrating its potential as a safe and effective~     treatment for troublesome sialorrhea.~   "
81237|NCT01994096|"~     Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to~     the presence of risk factors. It is known that in critically ill patients, alterations in~     function of various organs and body systems can influence the pharmacokinetics and hence the~     plasma concentration of a drug. A study of caspofungin in ICU patients has found a high~     inter- and intra-individual variability in caspofungin concentration. Factors that caused~     subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and~     hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin~     among patients with a higher disease severity score.~      As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can~     occur in critically ill patients and an adjusted dosage might be necessary in these~     patients.~   "
81238|NCT01994083|"~     The purpose of this study is to investigate the safety and tolerability of IX-01 after~     multiple doses, and to determine how the body handles IX-01.~   "
81239|NCT01994070|"~     Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency~     department (ED) patients. If the irregular heartbeat has been present for less than 48~     hours, there is a chance that emergency treatment can convert the heartbeat into normal~     rhythm.~      There are currently two options for accomplishing this; both are widely and safely used in~     EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)~     Patients are given an intravenous medication called procainamide; this converts patients~     into a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep~     with a general anesthetic) for about ten minutes, while an electrical current is conducted~     across the chest; this converts patients into a normal heart rhythm around 90% of the time.~      Procainamide can cause low blood pressure in about 10% of patients; this is usually~     corrected by administering intravenous fluids. Sedation can cause low blood pressure in~     about 10% of patients, and breathing trouble in about 10% of patients; this is usually~     corrected by administering intravenous fluids, and administering more oxygen, respectively.~     In thousands of patients studied around the world, there does not appear to have been a~     reported stroke or death as a result of these procedures.~      A physician will choose one method, but if it fails, will move to the next method. There are~     thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)~     Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+~     chance of converting AF into a normal heart rhythm. However, the investigators believe that~     an electrical-chemical sequence will be faster than a chemical-electrical sequence, while~     both will be equally safe.~      If patients agree to take part in the study, they will be randomized to one of the two~     options. They will have their breathing, oxygen levels, blood pressure, and heartbeat~     monitored for their entire ED stay.~      The investigators plan to enrol 86 patients at five hospitals over the course of about one~     year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as~     conversion to normal rhythm, and adverse events (such as trouble breathing or low blood~     pressure) will be documented. In addition, an investigator will contact you at three and~     thirty days after your visit to make sure that there are no problems. Importantly, although~     the principal and site investigators will be aware of the primary outcome, attending~     emergency physicians who actually provide patient care will NOT be aware of the primary~     outcome--otherwise this could bias patient management.~      When the study is finished, the results will be given to the writing committee merely as the~     A and B arms, and not specified as either the chemical-first or electrical-first~     arms. The writing committee will compose two manuscripts, (1) assuming that A is the~     chemical-first arm and B the electrical-first arm, and (2) assuming that A is the~     electrical-firstarm, and B the chemical-first arm. After both manuscripts have been~     approved by all authors, the blinding will be removed and only the correct manuscript~     submitted for publication.~   "
81240|NCT01994057|"~     For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy~     has been widely accepted since the success of crizotinib administration based on EML4-ALK~     fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs~     sensitive mutations.From clinical points of view ,individual differences often occur between~     different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect~     and adverse drug reaction was significantly influenced by the pharmacokinetic factors and~     pharmacodynamic factors.In this research ,we try to establish a more sensitive method to~     detect sensitive mutations in plasma and discover the correlation between somatic and~     germline mutations , trough concentration and EGFR-TKI drug effect, the association between~     ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo~     and in vitro research is also crucial for rational explanation for these clinical~     phenomenon.~   "
81257|NCT01993836|"~     This study will examine the hypothesis that changes in the cognition (i.e. thinking and~     memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers~     Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF),~     and/or changes in brain connectivity. The investigators will also examine whether different~     types of anesthesia have different effects on these CSF markers of Alzheimers disease, or~     different effects on thinking and memory after anesthesia and surgery, or differential~     effects on the correlation between cognitive changes and CSF marker changes.~   "
81258|NCT01993823|"~     The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment~     of otomycosis~   "
81241|NCT01994044|"~     Background: The majority of patients suffering a whiplash injury (WAD) will recover, but~     some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain~     Task Force (2008) found no existing evidence for positive effects of fusion operations in~     such patients. Some of them, however, present with symptoms that might indicate pain from a~     motion segment, possibly the disc. Our aim was therefore to test this possibility by~     performing a randomized study comparing cervical fusion and multimodal rehabilitation in~     chronic WAD patients.~      Methods: Patients with a specified symptomatology, all with pronounced symptoms for long~     periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal~     rehabilitation (24 pat.). All patients were investigated before start of the study and at~     follow-up approximately two years after treatment by four independent examiners from~     disciplines usually involved in treating WAD patients. The patients also gave their own~     assessments of the treatment results. Seven patients in each group did not undergo the~     allocated treatment for various reasons.~   "
81242|NCT01994031|"~     The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel~     liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome~     injection and paclitaxel injection and to value the effectiveness for cancer treatment.~   "
81243|NCT01994018|"~     The correlation between relapses in MS and vitamin D intake will be examined.~   "
81244|NCT01994005|"~     The scope of this project was to provide evidence that better contraceptive choices are made~     with more effective counseling as well as improvement in patients' contraceptive knowledge.~     Specifically we wanted to evaluate the use of social media as a means for effective patient~     counseling.~   "
81245|NCT01993992|"~     Post-operative delirium had multiple risk factors, such as pre-operative anxiety status,~     post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by~     parental accompanying until the children put to sleep. However, references indicate that~     parental anxiety can increase the post-operative delirium. Heart rate variability was used~     to measure the anxiety status of parents. We think sympathetic tone elevation measured by~     heart rate variability may not induce by anxiety alone, thus we want to explore this~     question by using Stat-Trait Anxiety Inventory questionnaire.~   "
81246|NCT01993979|"~     POUT is a multi-centred randomised controlled phase III trial. 345 patients who have~     undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node~     positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of~     adjuvant platinum based chemotherapy (experimental group) or surveillance (control group).~     Participants will be followed up according to routine practice.~      Primary endpoint: Disease-free survival (DFS)~      Secondary endpoints:~        -  Overall Survival~        -  Metastasis free survival~        -  Incidence of bladder second primary tumours~        -  Incidence of contralateral primary tumours~        -  Acute and late toxicity~        -  Treatment compliance~        -  Quality of life~   "
81247|NCT01993966|"~     Urothelial carcinoma (UC) is the most common cancer of urinary tract. Patients with~     metastatic UC are usually treated with systemic chemotherapy. There still existed 30% to 50%~     of advanced UC not responsive to cisplatin-based chemotherapy; the prognosis for patients~     with metastatic UC remains poor.~   "
81248|NCT01993953|"~     This study is a four armed randomized controlled trial (RCT) where the main purpose is to~     investigate the effect on muscle strength and changes in body composition in overweight (BMI~     ˂ 25) not regularly exercising women aged 18-65, after 12 weeks of Body Pump (BP),~     compared with an inactive control group. The study will also measure energy expenditure~     during one session of BP. At the same time, the project will investigate the effect on~     muscle strength and changes in body composition in group training with, respective without,~     a personal trainer (PT).~      H0: There`s no different between the groups after 12 weeks of Body Pump and traditional~     strength training with and without a personal trainer on muscle strength and muscle mass in~     adult overweight females.~      H1: There is a different between the groups after 12 weeks of Body Pump and traditional~     strength training with and without a personal trainer on muscle strength and muscle mass in~     adult overweight females.~   "
81249|NCT01993940|"~     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the~     treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain~     who are not using laxatives~   "
81250|NCT01993927|"~     To determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent~     progression to type 2 diabetes mellitus in patients with impaired glucose tolerance in the~     routine clinical setting.~   "
81251|NCT01993914|"~     The etiologies of varicose veins and the progression to more serious forms of chronic venous~     disease and identification of appropriate diagnostic tests to better aid patient management~     by identifying individuals who may benefit from more aggressive treatment and/ or~     prophylactic measures.~   "
81252|NCT01993901|"~     The principal aim of this study is to prospectively assess if Clinical Specialist Radiation~     Therapist (CSRT) led telephone follow up after treatment with lung Stereotactic Body~     Radiation Therapy (SBRT) has an impact on patient symptom burden as assessed by Edmonton~     Symptom Assessment Scale (ESAS) scores.~   "
81253|NCT01993888|"~     To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch~     (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding~     during hepatic surgery.~   "
81254|NCT01993875|"~     To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone,~     as compared to matching placebo, when administered orally to subjects with chronic~     idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a~     comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed~     in a subset of subjects.~   "
81255|NCT01993862|"~     The purpose of this study is to determine whether it is safe to send patients home from the~     hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.~   "
81256|NCT01993849|"~     To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC)~     in onychophagia, preliminarily assessing the tolerability and effects of this~     pharmacotherapy on young adults who bite their fingernails. It is proposed that NAC will~     help decrease fingernail biting.~   "
95660|NCT01805024|"~     The purpose of the study is to establish the pharmacokinetic profile of omigapil in~     paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of~     omigapil.~      Funding source - FDA OOPD~   "
81259|NCT01993810|"~     This randomized phase III trial studies proton chemoradiotherapy to see how well it works~     compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell~     lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a~     high dose of radiation directly to the tumor, such as photon or proton beam radiation~     therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon~     chemoradiotherapy in treating non-small cell lung cancer.~   "
81260|NCT01993797|"~     To evaluate the correlation between clinical and ultrasound findings in children presented~     with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis~     that will correlate with specific clinical outcomes.~   "
81261|NCT01993784|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The study assessed the safety~     and efficacy of different dosage of Nimotuzumab in second or late- line treatment of~     patients with locally advanced or metastatic esophageal squamous cell carcinomas.~   "
81262|NCT01993771|"~     This is a prospective, observational study, aimed to establish changes of bispectral~     bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during~     breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both~     frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between~     frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.~   "
81263|NCT01993758|"~     This study aims to determine whether the lower tourniquet pressure, which is set by adding~     120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet~     inflation, are efficient and safe during total knee arthroplasty, compared with the~     conventional tourniquet pressure: 150mmHg above the systolic blood pressure before~     tourniquet inflation.~   "
81264|NCT01993745|"~     The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in~     critical illness patients~   "
81265|NCT01993732|"~     The purpose of this study is to retrieve and cryopreserve ovarian tissue from females~     undergoing a treatment that may lead to irreversible loss of ovarian function.~   "
81266|NCT01993719|"~     Background:~        -  The NCI Surgery Branch has developed an experimental therapy that involves taking white~          blood cells from patients' tumors, growing them in the laboratory in large numbers, and~          then giving the cells back to the patient. These cells are called Tumor Infiltrating~          Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with~          melanoma.~        -  In this trial, we are determining if there is a difference in the response between~          patients who have received prior anti-PD1 treatment to those who have not received this~          prior ant-PD1 treatment.~      Objectives:~      - To determine if there is a difference in the rate of response between patients who have~     received prior anti-PD1 and those who have not.~      Eligibility:~      - Individuals at least 18 years and less than or equal to 70 years of age who have~     metastatic melanoma.~      Design:~        -  Work up stage: Participants will be screened with a physical exam and medical history.~          Blood and urine samples will be collected.~        -  Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white~          blood cells. White blood cells will be grown from the tumor in the laboratory.~        -  Leukapheresis: Participants will have leukapheresis to collect additional white blood~          cells. (Leukapheresis is a common procedure which removes only the white blood cells~          from the patient.)~        -  Treatment: Participants will receive standard dose chemotherapy to prepare their immune~          system to accept the white blood cells. Participants will receive an infusion of their~          own white blood cells grown from tumor. They will also receive aldesleukin for up to~          five days to boost the immune system s response to the white blood cells. They will~          stay in the hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
81267|NCT01993706|"~     Background:~      - VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV).~     Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or~     treat HIV infection. In this study they want to know if the study drug is safe if taken in a~     vein or under the skin. Taking VRC01 in this study will not protect against HIV infection.~      Objectives:~      - To see if VRC01 and placebo are safe and well tolerated.~      Eligibility:~      - Healthy adults 18 to 50 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and lab tests.~        -  Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given~          in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo~          dose.~        -  Three groups will receive VRC01 by needle into a vein with an IV pump. It will take~          about 1 hour and it is done in the hospital.~        -  One group will receive either VRC01 or the placebo by needle into the fatty tissue~          under the skin, usually the belly. It will take up to 20 minutes and it is done in the~          hospital.~        -  Participants will stay in the hospital overnight after receiving the medication and~          have about 14 clinic visits over 4 months. Most clinic visits last about 2 hours.~        -  Participants will keep a symptom diary after receiving the medicatino.~        -  Participants can volunteer to have mouth, rectal, and genital samples taken throughout~          the study.~        -  The study will last 8 months.~   "
81268|NCT01993693|"~     The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound~     device to reduce pain and increase mobility for subjects with knee osteoarthritis.~   "
81275|NCT01993602|"~     The lung expansion techniques are widely used to prevent postoperative pulmonary~     complications. However, the effect of each technique on thoracoabdominal mechanics after~     abdominal surgery and if it influences the rate of postoperative pulmonary complications~     remains unknown. The investigators hypothesis is that the lung expansion technique that more~     increases lung volume after abdominal surgery, will be the most efficient in preventing~     postoperative pulmonary complication after abdominal surgery. The investigators objectives~     will be to compare the effect of different lung expansion techniques on lung volumes and~     activation of inspiratory muscle, and prevention of pulmonary complications in patients~     undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective~     abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35),~     continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS,~     n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The~     thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications~     will be evaluated by a researcher who did not know to which group each patient belongs.~   "
95661|NCT01805011|"~     This trial is undertaken to better understand the ranges of functional components normally~     found in human milk. This will strengthen the scientific knowledge on breast-milk~     composition as a gold standard.~   "
81269|NCT01993680|"~     Disabling symptoms of blood pressure dysregulation, impaired swallowing and digestion are~     common amongst Parkinson`s patients. So far the exact pathophysiology for this is not fully~     understood. There are results from pathological analyses that the autonomic nervous system~     is also affected by the accumulation of alpha-Synuclein and that this might even happen in~     very early stages of the disease process (Qualman et al., 1984; Wakabayashi et al., 1989;~     Wakabayashi et al., 1990; Bloch et al., 2006).~      Blood pressure dysregulation is a common autonomic symptom in Parkinson`s patients and~     treatment - currently most often achieved with Fludrocortisone - often leads to supine~     hypertension (Plaschke et al., 1998; Braune et al., 1999; Magerkurth et al., 2005).~      There are studies in patients with autonomic failure that indicate that Pyridostigmine~     bromide might be an alternative treatment option without causing disabling supine~     hypertension (Singer et al., 2003; Sandroni et al., 2005; Singer et al., 2006; Yamamoto et~     al., 2006).~      Delayed gastric emptying is also an autonomic symptom associated with Parkinson`s disease.~     By the elevation of the cholinergic tone with Pyridostigmine bromide the investigators also~     expect to alleviate symptoms of delayed gastric emptying and obstipation, possibly even~     facilitating the uptake of dopaminergic medication through the gut (Sadjadpour, 1983;~     Bharucha et al., 2008).~      Therefore the investigators designed a monocentric randomized, controlled, double blind,~     crossover phase II trial to show non-inferiority of the effect of pyridostigmine bromide vs.~     fludrocortisone on symptoms of autonomic dysregulation in Parkinson`s disease.~   "
81270|NCT01993667|"~     Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude~     illness. The medication is effective in preventing acute mountain sickness (AMS), high~     altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is~     via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis~     which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the~     urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude~     disorders.~      Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to~     ascending in elevation. Side effects include tingling of the fingers and toes and perioral~     numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a~     mild diuretic, frequent micturition may occur leading to interruption of daytime activities~     as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is~     normally discontinued 2 days after the user has reached their highest elevation or a plateau~     in elevation.~      A lower dose may be just as effective in preventing high altitude illnesses while preventing~     the disconcerting side effects resulting from its use. A smaller dose has not been studied,~     however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg~     twice daily.~   "
81271|NCT01993654|"~     This study aims to validate the use of laser in vivo confocal microscopy as an early~     diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy~     of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection~     for early detection of tumor recurrence, and to evaluate the use of in vivo confocal~     microscopy in evaluation of response to treatment. The modified technique with Heidelberg~     Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence~     tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in~     differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like~     primary acquired melanosis and malignant melanomas. The OCT will potentially allow to~     estimate tumor depth in vivo as preliminary studies have shown.~   "
81272|NCT01993641|"~     The purpose of this open label study is to determine whether combining pracinostat (study~     drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in~     Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent~     hypomethylating agent (HMA), and to provide additional safety and efficacy data.~   "
81273|NCT01993628|"~     Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative~     pathologies. They differ in their expression, their evolution but share same features which~     make their diagnosis uneasy.~      Constructional apraxia has been described in both disease.The underlying mechanisms have~     been less studied and could be different in AD and LBD.~      The definition of the constructional apraxia is purely descriptive and few models are~     inconclusive.~      It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities,~     executive functions and working memory as well as purely constructive skills.~      Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD~     than in AD and are considered as an early onset sign of the disease.~      Executive functions deficits are documented in AD and LDB and could contribute to the~     drawing impairment.~      It is possible to compensate the planning disorders in giving patient the best strategy to~     use.~      If drawing impairment persists, they should result of others mechanisms like~     visuo-perception, visuo-spatial or constructive deficits.~      The investigators suggest that giving the best planning strategy will help more AD patients~     who are supposed to fail in raison of an executive impairment, than the LDB group who is~     supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral~     areas involved in constructional apraxia.~   "
81274|NCT01993615|"~     The purpose of this study is to compare the outcomes for patients that receive two different~     treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week~     supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to~     patients that have already been determined surgical candidates. The study is following~     patients for a 2-year period.~   "
81276|NCT01993589|"~     Patients frequently experience pain from moderate to severe during gynecologic procedures.~     This study is a prospective, randomized, placebo-controlled trial and aimed to investigate~     the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous~     paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage~     procedure.~   "
81277|NCT01993576|"~     The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch~     to detect the margine of the breast tumoral tissue.~   "
81278|NCT01993563|"~     The aim of the study is to evaluate whether a graded rehabilitation approach including~     Implicit and explicit motor imagery training and mirror therapy is more effective than other~     treatments commonly provided in a neuro-rehabilitation department.~   "
81279|NCT01993550|"~     The goal of this project is to examine the physical and psychological health benefits of a~     novel, telephone-delivered symptom management intervention for advanced lung cancer patients~     and their family caregivers.~   "
81280|NCT01993537|"~     Patients will undergo at baseline and regular intervals:~        -  clinically indicated bloodwork/urine and echocardiogram testing~        -  biomarker studies~      Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient~     and severely deficient. Normal and mild vitamin D levels will receive no treatment while~     severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D~     treatment. They will be seen in the heart failure clinic every 6 months. The patients will~     be followed for 26 months.~   "
81281|NCT01993524|"~     The purpose of this study was to determine whether supplementation of standard antibiotic~     therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences~     recurrence of bacterial vaginosis/vaginitis.~   "
81282|NCT01993511|"~     Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose~     metabolism leading to remission of type 2 diabetes early after surgery. However the~     mechanisms for this improvement remain uncertain. The aim of this study is to investigate~     the changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB~     using oral and intravenous test.~   "
81283|NCT01993498|"~     The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to~     generate predictors of chronic toxicity in patients with non-metastatic breast cancer.~      The project will include four specific aims :~        1. To develop a database of chronic treatment related toxicity in a cohort of 20 000 women~          with stage I-III breast cancer (= non metastatic), whatever these treatments are~          (surgery; radiation therapy; chemotherapy …)~        2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a~          maximum of 8 years.~        3. To describe the psychological, the social and the economic impacts of chronic~          toxicities.~        4. To generate predictors for chronic toxicities in order to prevent them, based upon~          biological criteria.~      The expected impact of these toxicities, when identified, will be to improve quality of life~     and to decrease health cost, by the early identification of patients at high risk of~     toxicity. Such early identification could lead to prevent toxic effect by: a. developing~     prevention strategies, b. substituting toxic treatment by a non (less) toxic one.~      Also, such cohort will offer a quantification of the impact of treatment toxicity, that~     could be further used to quantify medical usefulness of strategies that aim at decreasing~     treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free~     regimen etc…)~   "
81284|NCT01993485|"~     Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with~     a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in~     the 8th decades. AVS is independently associated with atheroclerosis risk factors and~     clinically apparent CV disease indicating that the degeneration of the aortic valve may~     represent an atheroclerosis-like process involving both, the aortic valve as well as the~     vascular system, respectivel. It is still unknown whether the endothelial function is~     affected as an manifestation of the atherosclerotic process, changes in the driving~     mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure~     effects.~      The investigators hypothesized that altered haemodynamics may at least partly be responsible~     for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study~     is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI)~     affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as~     markers of endothelial integrity.~   "
81285|NCT01993472|"~     The purpose of this study is to determine the efficacy and safety of Andrographolides~     combined with Capecitabine in treatment of elderly patients with locally advanced or~     recurrent or metastasis inoperable colorectal cancer~   "
81286|NCT01993459|"~     The purpose of this study is to determine whether Midazolam given pre-operatively to~     patients undergoing abdominal surgery improves the quality of recovery.~   "
81287|NCT01993446|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of rosacea when applied twice daily for 6 weeks.~   "
81288|NCT01993433|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of plaque psoriasis when applied twice daily for 6 weeks.~   "
81289|NCT01993420|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of atopic dermatitis when applied twice daily for 6 weeks.~   "
81290|NCT01993407|"~     The purpose of this research study is to investigate different types of task training to~     determine if training improves thinking processes following traumatic brain injury.~   "
81291|NCT01993394|"~     The primary aim of this project is to get further knowledge on the effects of + Gz~     accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study~     lung perfusion and cardiovascular function in these conditions.~   "
81292|NCT01993381|"~     The most common toxicity of chemotherapy is nausea and vomiting, and appropriate management~     of these toxicities can help patients improve tolerance for chemotherapy. Anti-emetics~     including dopamine antagonist, serotonin antagonist, and substance P antagonist administered~     to patients according to emetogenic risk of chemotherapeutic drugs. However, patients don't~     always experience same nausea and vomiting for the same drugs. Therefore, it is important to~     determine the biomarker to predict chemotherapy-induced nausea and vomiting. Some biomarkers~     studies were done during the chemotherapy. However it is not definite evidence of relations~     between biomarkers and chemotherapy. We will hope to find any predictive biomarker of CINV.~   "
81293|NCT01993368|"~     Periodontitis are inflammatory diseases characterized by the destruction of the~     tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are~     described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the~     severity and rapidity of bone loss, much more important for AP than CP. In both forms, the~     link with uncontrolled activation of the immune system is largely admitted. Despite the~     physiopathology of CP is fairly well studied, very few data are available regarding AP. The~     investigators aim is to understand the severity of AP by analyzing the proportion and action~     of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of~     periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will~     be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).~   "
95833|NCT01802762|"~     To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe~     and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF);~     cerebral blood volume (CBV)) obtained.~   "
81294|NCT01993355|"~     Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes~     for patient disability and a general recurrent cause for medical consultation with high~     costs to public health. From rehabilitative medicine, physiotherapy is commonly offered.~     Although this treatment is aimed to reduce disability, pain severity and pain-related~     anxiety-depressive symptoms, many patients report partial improvement and recurrent~     intensive and disabling pain episodes. Therefore, a new approach in the treatment and~     rehabilitation of this pathology that takes into account psychosocial aspects that might be~     modulating pain is necessary.~      Material and methods: This project aims to assess the efficacy of two complementary~     interventions to standard physical therapy, such as relaxation techniques and~     cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among~     patients with CLBP. It is hypothesized that groups receiving these complementary~     interventions will significantly improve their adherence to physiotherapy and the control of~     their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and~     better HRQoL.~      For these purposes, a pre-post longitudinal design will be carried out, with follow-up~     assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided~     into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation~     techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral~     intervention).~      Expected impact: Study results are not available yet. However, if working hypotheses are~     confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This~     approach is expected to benefit HRQoL among these patients implying a significant short-mid~     term reduction of public health costs.~   "
81295|NCT01993342|"~     The purpose of this study is to determine the concentration of different adipocytokine~     (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers~     as Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c~     protein in the synovial fluid of knee osteoarthritis patients, and compare with the~     inflammation detected with ultrasonography evaluation of the joint. In last years, some~     studies appeared focusing on the role of adipocytokines in osteoarthritis and they~     correlated adipocytokines with cartilage degradation and x-ray degree; in our study we will~     focused in the importance of adipocytokines in the inflammatory changes more than in joint~     destruction.~   "
81296|NCT01993329|"~     This is a randomised, double blind, double-dummy, placebo-controlled, three way crossover,~     single centre study in subjects with asthma undergoing inhalation of methacholine and ATP to~     assess the PC20 response of two dose levels of AF-219 compared with placebo.~   "
81297|NCT01993316|"~     Neurofeedback can be described as a form of biofeedback which is based on recording brain~     activity; usually by using scalp EEG. Neurofeedback has been used for 40 years as a~     therapeutic treatment for many neurological conditions including epilepsy, attention deficit~     hyperactivity disorder and also to improve mental performance in healthy subjects.~     Participants can see their brain activity via the EEG readings and receive positive~     feedback (visual or auditory) to help them consciously shape their brain waves into the~     desired patterns.~      sLORETA, which is speciliazed computer program to analyze EEG results, will be used in~     conjuntion with EEG to study the effect of neurofeedback on the brain activity of healthy~     subjects.~      In this study we will investigate the effect of neurofeedback training using sLORETA, which~     is a specific method to measure brain waves. We will measure the effect on both brain~     hemispheres both before and after neurofeedback training.~   "
81298|NCT01993303|"~     Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure~     and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D~     Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (~20 mCi)~     processed using a Monte-Carlo driven scatter correction algorithm against conventional~     higher dosage (~50 mCi) 2D Rb-82 PET MPI.~   "
81299|NCT01993290|"~     Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL),~     Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study~     of the single-penetration multiple-injection-technique.~   "
81300|NCT01993277|"~     The study is an open-label comparative effectiveness clinical trial evaluating the impact of~     three neuromodulation treatment devices to improve the mental health and sobriety status of~     recovering substance abuse patients. We intend to enroll 200 patients to give us a~     sufficient number of subjects for the planned comparisons. Following informed consent and~     baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute~     sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device,~     once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace~     Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute~     sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within~     a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy~     sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at~     the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the~     assigned treatments, all patients will also receive the standard array of services that are~     provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically~     appropriate, psychiatric medication management and Eye Movement Desensitization Response~     (EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed~     to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR~     sessions. Patients without PTSD do not receive EMDR therapy.~   "
81301|NCT01993264|"~     Cardiac disease in children may start early in life and evidence of cardiac disease can be~     seen during prenatal life. A variety of diseases diagnosed during fetal life can put~     children at risk for cardiac disease. The accurate assessment of cardiac function is~     important in these patients. A type of imaging scan called fetal echocardiogram is used to~     measure the contractility or squeeze of the heart. The fetal echocardiogram is a painless~     test and completely non-invasive.~      This study aims to recruit women and fetuses to determine if this imaging scan can be used~     throughout the pregnancy to measure heart squeeze and develop normal values to help doctors~     better diagnose fetuses who may have cardiac disease before they are born.~   "
81325|NCT01992952|"~     This is a two stage study, with an initial dose escalation phase I study and subsequent~     double blind randomised phase II controlled trial. Eligible patients are post-menopausal~     women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should~     be suitable for endocrine treatment, but have received no more than 3 previous lines of~     endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also~     have had progressive disease during treatment with an aromatase inhibitor. Following the~     dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either~     placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once~     daily.~      Patients will receive fulvestrant in combination with either placebo or AZD5363 until~     disease progression. Patients may continue to receive fulvestrant and AZD5363/placebo~     treatment even after the last trial visit.~   "
81302|NCT01993251|"~     Although behavioral disorders origins in autistic children are still unclear, they seem to~     be influenced by sleep disorders. Results of studies performed on sleep quality in autistic~     children showed a high prevalence of sleep disorders in these children, estimated between 50~     and 80% compared to children with typical development and insomnia is one of the sleep~     disorders most frequently reported by autistic children's parents. Others studies showed~     circadian rhythm disorder in autistic children which could be the consequence of genetic~     abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission~     modulation.~      Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of~     sleep proposed for insomnia treatment and circadian rhythm disorders.~      Two major recent studies (not yet published) in the United States and in England seek to~     show the effectiveness of melatonin by testing the effects of three doses of melatonin on~     reducing sleep disorders.~      It is therefore interesting and important to conduct a parallel study to assess the~     melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total~     sleep time…), but on sleep quality (number of nocturnal awakenings).~      The strength of this study lies in the combination of several measurement tools to assess~     the melatonin dose-effect on all parameters in both physiological (actimetrics,~     polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep~     questionnaire, index of insomnia severity, rating scale autistic disorder) as well as~     possible side effects.~      The primary objective is to determine the most effective dose of melatonin to improve sleep~     quality in autistic children.~   "
81303|NCT01993238|"~     The objectives of this study are to evaluate the safety and effectiveness of procedural~     analgesia for improvements in tolerability of treatment with the Liposonix System.~   "
81304|NCT01993225|"~     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men~     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm~     Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.~   "
81305|NCT01993212|"~     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men~     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm~     Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.~   "
81306|NCT01993199|"~     Upper gastrointestinal subepithelial tumors are frequently encountered during~     esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by~     algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography~     alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient~     accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of~     subepithelial tumors.~      Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection~     technique and multiple endoscopic biopsies were performed.~      The investigators will perform deep biopsy in subepithelial tumor.~   "
81307|NCT01993186|"~     UX007 is more effective than placebo for the reduction of seizures in patients with Glut1~     DS, as measured by the reduction from baseline in frequency of generalized or partial-onset~     seizures, including: Generalized Tonic-Clonic, Generalized Tonic, Generalized Clonic,~     Generalized Atonic, Partial/Focal with Secondary Generalization, Myoclonic, Myoclonic~     Atonic, Myoclonic Tonic, Complex Partial/Focal, Absence and Simple Partial/Focal Motor~     seizures~   "
81308|NCT01993173|"~     The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared~     to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in~     participants in China.~      Primary objective:~        -  To describe diphtheria and tetanus seroprotection rates and pertussis booster response~          rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),~          local DT vaccine (in children), and local Td vaccine (in adolescents and adults).~      Secondary Objectives:~        -  To further describe in each group the immunogenicity of the study vaccines at baseline~          and 1 month after vaccination.~        -  To describe the safety of the study vaccines~   "
81309|NCT01993160|"~     This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging~     patients with high risk prostate cancer.~      Study Hypothesis:~      FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as~     compared to conventional imaging.~   "
81310|NCT01993147|"~     The purpose of this study is to learn more about the brain circuits involved with effortful~     control in healthy adult participants. Study participants will be given either~     methylphenidate (also known as 'Ritalin')which is an FDA approved, most widely-used~     medication given to those diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)or a~     placebo, which is a sugar pill. Each participant will also perform some computer tasks that~     have been shown in previous studies to require effortful control while undergoing an fMRI~     (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain.~     Our goal is to learn more about the brain mechanisms by which methylphenidate improves~     effortful control.~   "
81311|NCT01993134|"~     The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in~     patients with facial fractures admitted to the Oral and Maxillofacial Surgery and~     Traumatology services of the Onofre Lopes University Hospital attached to the Federal~     University of Rio Grande do Norte.~   "
81312|NCT01993121|"~     The objective of the current proposal is to evaluate the importance of blood vessel~     dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and~     their contribution to the gender differences observed in exercise capacity. Importantly,~     treatments that improve blood vessel function in persons with type 2 diabetes can be used to~     directly assess whether impairment in blood vessel function and ultimately exercise~     performance, can be improved and whether the degree of improvement differs between the~     sexes.~      Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in~     women than men.~      Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in~     women with type 2 diabetes than men and contribute to the gender differences in exercise~     capacity.~      Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in~     women than men with type 2 diabetes.~   "
81353|NCT01992588|"~     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the~     investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and~     insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous~     insulin infusion (CSII).~   "
81313|NCT01993108|"~     The goal of this research is to understand the functioning of 'regulatory circuits' in the~     brain. These are brain circuits which allow a person to regulate their attention, regulate~     their behavioral responses, and regulate their decision-making. We are also interested in~     how the stimulant medications methylphenidate and naltrexone affect these regulatory~     circuits. Methylphenidate is a widely-used, FDA approved medication used to treat Attention~     Deficit Hyperactivity Disorder (ADHD) and is also known as Ritalin. Naltrexone is an FDA~     approved medication used to help treat alcohol and substance abuse.~      This research study will use a scanning technique known as functional magnetic resonance~     imaging (fMRI)which takes a special kind of picture of the brain that enables us to see the~     brain at work. Adult participants will be given a one-time dose of either methylphenidate,~     naltrexone,or placebo before each fMRI scan session. There are three total fMRI scan~     sessions. Therefore, each participant will receive each possible medication/placebo only~     once.~      Thus, using the fMRI technique, our main purpose for this research is to better understand~     the functioning of regulatory circuits in conditions such as ADHD and alcohol dependence.~     This research may one day help us develop better treatments for these disorders.~   "
81314|NCT01993095|"~     The purpose of this study is to test the effectiveness of a DVD-delivered, home-based~     six-month physical activity intervention for people with Multiple Sclerosis.~   "
81315|NCT01993082|"~     The purpose of this study is to determine whether an aerobic training intervention will~     alter markers of immune cell aging, improve exercise capacity and blood pressure and~     decrease psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched~     wait list control caregivers.~   "
81316|NCT01993069|"~     The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with~     mild post-traumatic and chronic tension-type headaches.~      Study Aims:~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tension-type headaches experience, assist in decreasing~          headaches and associated symptoms?~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tensions-type headaches experience, assist in improving~          quality of life?~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tension-type headaches experience, improve mood?~        -  Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post~          completion of treatment?~   "
81317|NCT01993056|"~     According to available data the injury rate in male veteran soccer is high. Interventions to~     prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and~     consists of several exercises with an overall-length of about 20 min. This study shall~     investigate the influence of 11+ on injury incidence and Functional Movement Screen~     (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a~     relationship between FMS-Score and injury incidence. For this purpose the 11+-program is~     accomplished under supervised conditions over one regular season in a randomized-controlled~     study design. Injuries are documented via questionnaires in accordance with the~     FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.~   "
81318|NCT01993043|"~     Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular~     endothelium growth factor (VEGF) is an important component of this disease. The goal of~     treatment is to reduce the production of VEGF in the immature retina and to eliminate the~     abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral~     avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody~     Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However,~     VEGF is important for the development of neurons and vessels in the systemic organs in~     premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream.~     It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and~     longterm effects on ocular and systemic systems, especially neurological development. In~     this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature~     infant and to compare the short and long-term vision and neurodevelopmental outcomes of~     infants treated with IVB compared to laser ROP.~   "
81319|NCT01993030|"~     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical~     Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix~     Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.~   "
81320|NCT01993017|"~     The purpose of this study is to examine, in a randomized controlled trial, the benefits and~     costs of the American Heart Association's (AHA) advisory for depression screen and treatment~     of post-acute coronary syndrome patients.~   "
81321|NCT01993004|"~     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported~     in many human diseases. The purpose of this pilot study is to determine if microRNA~     expression is changed in untreated and glatiramer acetate-treated patients with multiple~     sclerosis.~   "
81322|NCT01992991|"~     The purpose of this study is to investigate the effect of transcranial stimulation for upper~     limb training of patients with sequelae from an intracranial hemorrhage.~      Patients receive five days of upper limb occupational therapy training in combination with~     real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before,~     after and 7 days later. The intervention takes place at patients' home address.~   "
81323|NCT01992978|"~     Surgical resection is the most effective treatment of primary and secondary liver tumors.~     Technical innovations have mainly focused on minimizing bleeding during transection of the~     hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are~     associated with increased postoperative morbidity and mortality.~     Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread~     acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the~     prognosis of HCC patients，especially for those with cirrhosis，is still controversial.~     Therefore, we design this prospective clinical trial to explore the effect of RFA~     hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and~     prognosis of HCC patients with cirrhosis.~   "
81324|NCT01992965|"~     The purpose of the study is to evaluate the effect of real-time continuous glucose~     monitoring system on glucose control and outcomes of critically ill patients.~   "
81326|NCT01992939|"~     This is the second part of a research study in order to determine if using a specialized~     pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and~     heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD),~     vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and~     pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled.~     SaO2 and pulse readings are important to maintain patient stability during diagnostic~     testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2~     and pulse are important to monitor in order to be able to compensate for any decrease in~     patient oxygen saturations during hemodynamic monitoring.~      The primary aim of this study is to determine if using a specialized pulse oximetry probe~     with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse~     readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to~     readings obtained from an arterial blood gas.~      The hypothesis is using a specialized pulse oximetry probe with external heat pack will help~     obtain more accurate pulse oximetry readings consistent with values obtained with an~     arterial blood gas.~   "
81327|NCT01992926|"~     Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney~     disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise~     and fatigue. The current accepted practice is often to administer erythropoietin-stimulating~     agents (ESAs), which act like the body's natural hormones to stimulate the production of red~     blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests~     that they are not as safe as previously thought. In this study, we seek to test a decision~     aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of~     the decision aid is to reduce patient confusion, improve their satisfaction with their care,~     improve their knowledge of kidney disease, and ultimately bring more clarity to patients~     about a controversial but ubiquitous drug.~      The decision aid will be about 1 page long and will include questions and information that~     might help the patient be more active and informed regarding the choice of a course of ESA~     therapy. We will ask patients to answer questions before and after their clinic visits~     regarding their satisfaction and confidence in their treatment and their knowledge of kidney~     disease; we will ask some of the same questions 3 months after the clinic visit. We will~     compare patients who are counseled using the decision aid to patients who are not. We~     anticipate total experiment running time to be approximately 5 months to recruit and follow~     up on all patients.~   "
81328|NCT01992913|"~     Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive~     skills, social skills, and functional skills (like employment). There is a new form of~     cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that~     specifically addresses the cognitive, social, and functional deficits of~     schizophrenia/schizoaffective disorder. This study is to compare iCBT to the usual care (UC)~     that Veteran's receive. The investigators will compare iCBT to UC in subjects with~     schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE)~     program, and evaluate whether iCBT is more helpful in improving job performance, and other~     areas of functioning, both right after treatment, and 6 months after the end of treatment.~   "
81329|NCT01992900|"~     There is a need for paediatric formulations that permit accurate dosing and enhance patient~     compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations~     are available on the market. Thus, a new water dispersible formulation of eurartesim has~     been developed for oral administration.~      Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this~     new paediatric formulation and compare it with the crushed film coated tablet in infant~     patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum~     malaria.~      Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to~     establish PK/PD relationship in adult and paediatric populations.~   "
81330|NCT01992887|"~     Retention of patients in HIV care following diagnosis and enrollment is critical to the~     long-term success of HIV care and treatment scale-up. The goal of this study is to better~     understand the factors that influence retention and engagement in HIV care among adult~     patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy~     (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera~     Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and~     quantitative (surveys) data collection. Our findings will be important towards designing~     programs that help patients remain in HIV care.~   "
81331|NCT01992874|"~     This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over~     trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in~     cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial~     extension phase).~   "
81332|NCT01992861|"~     This clinical trial studies magnetic resonance imaging (MRI) and positron emission~     tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA~     cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a~     computer are used to create detailed pictures of areas inside the body. PET is a procedure~     in which a small amount of radioactive glucose (sugar) is injected into a vein, and a~     scanner is used to make detailed, computerized pictures of areas inside the body where the~     glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done~     before, during and after radiation and chemotherapy may help doctors predict a patient's~     response to treatment and help plan the best treatment.~   "
81333|NCT01992848|"~     Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an~     estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with~     atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated~     CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as~     regulators of gene expression, have also emerged as powerful biomarkers in the diagnosis and~     prognosis of cardiovascular disorders and may be used in the detection of CAC. We aim to~     investigate the potential for a microRNA-signature in patients with CAC by performing a~     prospective, case-controlled study to identify pathways associated with CAC in humans.~     Previous research has demonstrated an inverse relationship between CAC and bone mineral~     density (BMD), suggesting that these processes may be linked. In a further substudy we plan~     to define the relationship between CAC and BMD as well as a number of markers of bone~     metabolism.~   "
81334|NCT01992835|"~     After an allergen challenge, the allergic inflammatory response disappears spontaneously.~     The initiation of the resolution of the inflammatory response is now recognized as a dynamic~     process, involving active biochemical programs that enable inflamed tissues to return to~     homeostasis. Recent data established key roles of different specific lipid mediators in the~     endogenous counter-regulation of inflammation and activation of resolution. Only little is~     known about kinetics of these specialized pro-resolving lipid mediators during acute~     allergic inflammation. Therefore, the primary propose of our study is to characterize the~     temporal evolution of cellular inflammation and specific lipid mediators after allergen~     challenge.~   "
81335|NCT01992822|"~     The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the~     clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists~     in the evaluation of the experimental sensitivity to mechanical pain (pressure application~     on the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21~     days), and to put the results in relation to the clinical improvement and the psychometric~     evaluations (depression,fibromyalgia impact questionnaire, catastrophism).~   "
81336|NCT01992809|"~     Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose~     spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a~     history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD),~     has emerged as a clinically important type of chronic liver disease in industrialized~     countries and is characterized pathologically by hepatocellular ballooning, Mallory's~     hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis~     can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur~     post transplantation.In the absence of established treatment, therapy is generally directed~     to treatment of risk factors for metabolic syndrome. Recently, some studies have been~     demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa,~     IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound.~     Neverthless, this is the first study that evaluate liver histology after six months of PUFA~     (omega3) in the treatment of patients with NASH.~   "
81337|NCT01992796|"~     The investigators propose a clinical study of irbersartan for the early treatment of severe~     sepsis patients with elevated predicted risk of death between. This study will evaluate~     whether early administration of the the angiotensin receptor blocker irbersartan provides~     significant reduction of 28 days mortality and multi organ failure incidence to patients~     with severe sepsis.~   "
81338|NCT01992783|"~     The aim of this study is to evaluate whether supplementation with resistant starch improves~     biomarkers associated with antioxidant status and insulin resistance in subjects with~     overweight and obesity.~   "
81339|NCT01992770|"~     Background:~      This study is based on an innovative stepped-care protocol for the management of~     musculoskeletal pain in primary care, which is evaluated in a RCT. The intervention have two~     core features: it is theory-driven and include systematic tailoring of treatment content.~     The tailoring is based on a combination of empirically supported behavioural and medical~     determinants of pain-related disability and patients' individual perceptions on personal~     goals, facilitators and barriers for health behavior change. In this application, the~     intervention is labelled tailored behavioural medicine intervention (TBM).~      Objectives:~      The aim is to compare effects and cost-effectiveness of a stepped care model including~     advice and tailored behavioral medicine pain treatment (experimental condition) with a~     stepped care model including advice and physical exercises (comparison condition) for~     patients with low back and neck pain and/or widespread pain including fibromyalgia in~     primary care. A further aim is to characterize patients who benefit/do not benefit from the~     respective steps i.e. treatments varying in dose and content.~      Methods:~      A stratified randomized stepped care design is applied. Stratification is based on primary~     care center and patient risk profile. A consecutive selection is performed at primary care~     centers in southern, central and northern Sweden. According to power analysis, 364~     participants should be recruited to allow for sub-group analyses. After having received a~     minimal intervention (step 1) comprising 'stay-active advice', participants scoring >90 on~     the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) are randomly allocated to an eight-week~     treatment in step 2. The experimental condition includes supervised physical exercises~     integrated with either (a) graded activity, or (b) hierarchical graded exposure depending on~     risk profile, i.e. absence or presence of pain catastrophizing and fear-avoidance beliefs.~     The comparison condition includes supervised physical exercises irrespective of risk~     profile. Primary outcome is pain-related disability complemented with a comprehensive set of~     secondary outcomes adhering to the IMMPACT recommendations. Assessments will be made by~     personnel blinded for treatment condition at baseline, after step 1 and 2 respectively, and~     at 12- and 24-month follow-ups.~   "
81340|NCT01992757|"~     This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF)~     levels on cardiopulmary bypass during cardiac surgery can provide information on coagulation~     status sooner, allowing for anticipation of post-bypass bleeding and transfusion~     requirements~   "
81341|NCT01992744|"~     The purpose of this study is to evaluate the correlation between varying levels of~     neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the~     body in very small amounts but without which the nervous system cannot function properly,~     and which might have a role in the health of a newborn. As part of this study, we are~     collecting blood samples from pregnant women.~      Neuropeptides and hormones can be measured in blood. This study will involve three blood~     draws from the participants arm. Demographic information will also be requested, and~     participants will be asked to complete questionnaires about their mood and personal~     experiences at each visit.~      Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor~     (BDNF) will be at increased risk for poor birth outcomes.~   "
81342|NCT01992731|"~     Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged~     38-42 years.~   "
81343|NCT01992718|"~     To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to~     benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by~     evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging),~     ultrasound and ultrasound with elastography).~   "
81344|NCT01992705|"~     Primary Objective: To determine the rate of downstaging to resectability in patients with~     borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative~     therapy.~      Secondary Objective(s):~        1. To assess the disease-free-survival, overall survival, time to recurrence and site of~          recurrence in patients with borderline resectable pancreatic cancer receiving~          preoperative FOLFIRINOX followed by SBRT~        2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with~          resectable pancreatic cancer~        3. To determine the radiologic and pathological response associated with preoperative SBRT~          and FOLFIRINOX therapy~        4. To assess quality of life through and after treatment using the FACT-Hep questionnaire~   "
81345|NCT01992692|"~     Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of~     about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by~     several studies for concerning the interactive reaction between anesthetics and~     anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience~     showed that the patients undergoing pulse generator placement were more prone to be involved~     in delayed emergence in the recovery room, which had been not reported yet. We speculated~     that PD patients might be a special population with abnormal pharmacodynamic characters of~     anesthetics, though no related evidence could be found to support this hypothesis.~     Therefore, in this project we investigated whether remifentanl requirement to inhibit~     patients' response to trachea intubation and skin insertion in PD patients undergoing DBS~     and pulse generator placement was different from non-PD patients undergoing intracranial~     surgery for reasons other than PD.~   "
81346|NCT01992679|"~     There is growing evidence that exercise-based rehabilitation results in improvements in~     mobility and participation in persons with multiple sclerosis (MS). However, the vast~     majority of the scientific evidence in support of this view is based on persons with MS who~     have minimal mobility impairment. This is partially due to the lack of accessible exercise~     equipment and facilities available to persons with severe mobility limitations.~      One option available to persons with severe mobility limitations is body weight supported~     treadmill training. Indeed, this rehabilitation approach has been utilized with some success~     in various clinical populations, such as stroke and spinal cord injury, and is believed to~     target neuroplasticity. Specific to persons with MS, body weight supported treadmill~     training has shown great promise in improving quality of life, symptoms and functional~     mobility in two small (n=4 and n=6) pilot investigations. However, previous research has~     been hampered by methodological limitations including small sample size, lack of a control~     group and limited training sessions. Consequently, no firm conclusion regarding the benefit~     of body weighted supported treadmill training in persons with MS can be drawn. The proposed~     project seeks to determine if twenty-weeks of body weight supported treadmill training leads~     to improvements in physiological function, mobility and quality of life in persons with MS~     with severe mobility limitations. The outcomes of this project have the potential to lead to~     new rehabilitation approaches capable of improving function and quality of life in persons~     with advanced MS.~   "
81347|NCT01992666|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology~     includes genet-ic and environmental factors. It is rare in children as compared to adults.~     The severity may be related to greater involvement of genetic factors in children. The~     impact of genetics in the development of SLE is important, and the risk of recurrence in~     siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8~     rheumatoid arthritis, thereby indicating high impact of genetics in SLE.~      Recently, the group of Professor Yanick Crow in Manchester and other teams has identified~     new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite~     lupus.~      Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene,~     which therefore represents the first genetic cause of SLE. The team of Professor Crow also~     identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal~     enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in~     two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of~     SLE. These new genes SLE were identified through research of germ-line mutations in cases of~     lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing~     characterization of a novel gene of SLE in a family and we have identified a second locus~     identified in another family. The identification of these genes provides a better~     understanding of the mechanisms regulating immune tolerance in humans. The frequency of~     these genetic forms is not known. There is very little data on the immunological phenotype~     of these patients.~      This is a clinical study to investigate the genetic and immunological abnormalities~     associated with pediatric SLE. The aim are to:~        -  study the genetics of pediatric SLE (or syndromic or family) and to search for~          mutations in the known genetic lupus or new genes in collaboration with Professor~          Yanick Crow.~        -  study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE~          (or syndromic or family) in the large Rhône- Alpes- Auvergne area.~   "
81348|NCT01992653|"~     This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability,~     pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with~     rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy)~     in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating~     doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard~     doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy~     (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with~     local institutional practice. Two parallel treatment arms will explore doses of polatuzumab~     vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended~     Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified~     before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin~     will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of~     this combination.~   "
81349|NCT01992640|"~     During laparoscopic surgery, muscle relaxants are often administrated in order to ensure~     acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.~      The degree of muscle relaxation is monitored by use of an acceleromyography and at the end~     of surgery another drug - Neostigmine- is given to reverse the muscle relaxation.~     However,there may still be a blockade of up to 70% of the receptors.~      This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged~     hospitalization.~      This study will describe changes in balance and subjective muscle weakness after~     laparoscopic surgery.~      The primary hypothesis is that sway area is increased 30 min after extubation compared to~     the preoperative value.~   "
81350|NCT01992627|"~     This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the~     treatment of elbow epicondylosis~   "
81351|NCT01992614|"~     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary~     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.~   "
81352|NCT01992601|"~     This clinical trial is designed to compare the pharmacokinetic characteristics of~     combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan).~     Also investigate drug interaction between separate and combination administration.~      Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day~     administration, 16 days washout after 6th day of administration.~      The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over~     design during 2 each period.~      The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a~     cross-over design during 2 each period.~   "
81354|NCT01992575|"~     Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of~     these conditions, retinal vein occlusions are the most common. Vision loss can occur as a~     result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid~     build-up at the macula).~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structures in real time. It is similar to ultrasound imaging, except~     that OCT measures the intensity of reflected light rather than sound waves.~      The purpose of this study is to see if non-invasive OCT technology can changes due to~     retinal vein occlusions as well as the more invasive fluorescein angiography, which requires~     an injection of dye into the vein of an arm of a patient. The study will also compare the~     mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein~     angiography and OCT. These studies will be evaluated to see how they relate to vision loss.~   "
81355|NCT01992562|"~     This is a phase 4 study being conducted at the Ohio State University Department of Neurology~     Multiple Sclerosis Research Program. The purposes of the study is to administer a single~     shot of intrathecal (injection into the space surrounding the spinal cord via a lumbar~     puncture or spinal tap) ziconotide as a test dose to patients who have chronic painful~     myelopathy (pain from spinal cord damage) or painful peripheral neuropathy (pain from nerve~     damage) that has not responded to other pain medicines. Study Hypothesis: We intend to~     determine if a single shot trial (SST) of intrathecal (IT) ziconotide will temporarily~     reduce pain in these patients. In the proposed study, patients will receive two injections,~     one of which is the ziconotide and one which is a placebo. They will be blinded and not know~     which order they receive the treatment versus placebo. The results of this clinical trial~     will provide a focused examination of ziconotide efficacy and safety in patients with~     painful neuropathies or myelopathies that have not been effectively treated with other pain~     medications. Moreover, the use of a single shot trial (SST) IT injection in the outpatient~     setting will provide evidence for application of this technique in outpatient neurological~     clinical practice, thereby improving access to this specific patient population. Ziconotide~     is currently FDA approved for this indication and route of administration. Therefore, a~     study design that improves the feasibility of ziconotide trialing specifically in the~     neurology clinic (that is, single shot administration) is being used in order to ensure its~     broader use by neurologists who routinely care for neuropathy and myelopathy patients.~     Information from this study will also inform future studies of predictors for long term~     efficacy after pump placement.~   "
81356|NCT01992549|"~     The purpose of the study is to collect long-term data on the inhibitor development rate of~     Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.~   "
81357|NCT01992536|"~     The purpose of this extension study is to evaluate the immunogenicity and safety of a~     booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary~     vaccination series, in subjects who previously received the same vaccine formulation in~     study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months~     after the primary vaccination and 12 months after the booster dose will also be evaluated in~     these subjects.~      In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations~     (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously~     received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV).~     These subjects will be followed for safety and immunogenicity for 12 months after~     vaccination in study V102_03E1.~   "
81358|NCT01992523|"~     The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the~     superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill~     both orally administrated in decreasing residual platelet reactivity 1 hour after the~     administration among 70 patients with STEMI (ST segment elevation myocardial infarction)~     undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.~   "
81359|NCT01992510|"~     The study was conducted to investigate how postural changes including sitting, supine, and~     LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone~     oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes~     and the fellow eyes in each body position.~   "
81360|NCT01992497|"~     Effect, tolerance and safety of a supplementation with a probiotic on the risk of~     gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term~     infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in~     the formula-fed and in the breastfed feeding groups.~   "
81361|NCT01992484|"~     The aims of the study are to:~        -  explore whether platelet reactivity in patients treated wih novel platelet inhibitors~          is associated with clinical outcome~        -  investigate whether a therapeutic window exist for novel platelet inhibitors~        -  investigate the incidence of adverse events under treatment with novel platelet~          inhibitors in the real life clinical scenario~        -  investigate the association between genetic polymorphisms, inflammation, platelet~          reactivity and clinical outcome~        -  investigate synergistic effects between aspirin and novel platelet inhibitors~   "
81362|NCT01992471|"~     The purpose of this study is to find out what kinds of information people would like to~     receive from a new kind of genetic testing, and how they respond to this new kind of~     testing.~   "
81363|NCT01992458|"~     The indication of implantable cardioverter defibrillator (ICD) therapy for primary~     prevention of sudden cardiac death has been introduced later in France than in other parts~     of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10~     year period.~   "
81364|NCT01992445|"~     Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated~     suicide attempt.~   "
81365|NCT01992432|"~     This study will use advanced MRI techniques to characterize the changes that occur to the~     structure and functionality of the brain in older breast cancer patients receiving adjuvant~     chemotherapy, and determine the relationship between the brain changes and severity of~     chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging~     markers of aging, breast cancer and chemotherapy treatment, and will contribute to our~     understanding of the underlying pathophysiology of cognitive changes and chemotherapy~     toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the~     foundation for future, larger scale clinical studies of cognitive changes and chemotherapy~     toxicity in the aging cancer population.~   "
81367|NCT01992406|"~     Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access~     routes give the opportunity to reduce surgical access trauma leading to a more painless~     surgery and enhancing a fast postoperative recovery. Experience with transvaginal~     laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show~     that such NOTES procedures are feasible and safe. The complication rate to conventional~     laparoscopic procedures is similar. Since transvaginal access is impossible in men, an~     alternative route is missing. There are experimental studies and small case series reporting~     the feasibility of transrectal anterior resection. However any prospective feasibility study~     demonstrating the safety of the procedure and functional outcomes (sphincter function) are~     missing. This study investigates the feasibility, practicability, safety and subjective as~     well as functional outcome of transrectal hybrid-NOTES anterior resection.~   "
81368|NCT01992393|"~     For this project we propose to refine the psychosocial intervention developed in phase one,~     based on input from key stakeholders, and to test the feasibility, acceptability and~     preliminary efficacy of the intervention. The proposed project addresses unmet public health~     needs for a historically hard-to-reach group of individuals with epilepsy and comorbid~     serious mental illnesses, and as the intervention is an adjunct to care that individuals~     with serious mental illness are already receiving, and uses staff already likely to be~     present in a care system, it is ideally suited for real-world implementation in people~     with epilepsy and serious mental illness (E-SMI).~      The purpose of this study is to try and engage individuals with E-SMI to actively~     participate in illness self-management and treatment adherence that are crucial in~     minimizing the morbidity and mortality associated with both chronic mental disorders and~     chronic neurological conditions.~   "
81369|NCT01992380|"~     This study will test if two 18F-AV-1451 PET scans up to 4 weeks apart in healthy volunteers,~     MCI and AD subjects provide the same results.~   "
81370|NCT01992367|"~     This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the~     safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD)~     of ASLAN003 in healthy subjects~   "
81371|NCT01992354|"~     The PET/MR device components and accessories are under development in order to optimize,~     validate and improve the design including improving the quality of images. The purpose of~     this study is:~        -  Aim 1: Perform iterative evaluations of the device (including features and components)~          to optimize device performance and assess feasibility of new features;~        -  Aim 2: Perform activities in support of design validation as needed for regulatory~          submission;~        -  Aim 3: Evaluate device complaints and analyze potential causes.~   "
81372|NCT01992341|"~     The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone~     and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of~     paclitaxel~   "
81373|NCT01992328|"~     Immunoglobulin G deficiency subtypes in patients with asthma six months once a month~     intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on~     reducing the frequency of asthma exacerbations appreciate.~   "
81374|NCT01992315|"~     Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose~     tissue, continues to be the tissue of choice in repairing soft tissue defects due to~     traumatic or other defects. Current autologous fat transfer techniques, however, have a~     number of limitations including significant donor site morbidity, unpredictable resorption,~     and the potential for requiring revision. Thus, an off-the-shelf material that retains the~     mechanical and biological properties of adipose tissue would be ideal for the~     reconstruction.~      Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic~     biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our~     collaborators have recently generated a novel tissue-derived material to improve soft tissue~     reconstruction. The final, processed adipose tissue does not contain cellular components,~     yet retains the native architecture and bioactivity of the original adipose tissue. The~     tissue is then further processed into particles to create an injectable implant. In~     preclinical models, we have demonstrated that human adipose tissue can be decellularized by~     mechanical processing with preservation of matrix ultrastructure. Histologic analysis~     two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue~     integration of the decellularized, dilipidized, adipose derived-ECM.~      The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue~     implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after~     6 weeks. Specifically, the volume of the soft tissue defect will be determined before~     implantation and at multiple time points over the following 6 weeks. We hypothesize that the~     decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks.~     If our results are promising, decellularized adipose derived-ECM may be a viable alternative~     to autologous tissue transplantation for correction of soft tissue deformity.~   "
81375|NCT01992302|"~     In this study we tried to elucidate the factors associated with the development of a rapid~     cycling course in bipolar disorder patients, in a prospective and longitudinal design, and~     the role of antidepressants. The identification of risk factors is extremely relevant from~     the clinical point of view. We hypothesized that rapid cycling bipolar disorder is~     associated with more chronicity, poor outcome, and more antidepressant prescription.~   "
81376|NCT01992289|"~     The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated~     ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The~     efficacy evaluations will incorporate growth and development parameters, frequency of~     infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ~     function. The safety evaluations will include physical examinations, adverse events and~     concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD~   "
81377|NCT01992276|"~     The purpose of this study is to evaluate the rate of decline in quantitative viral load~     measured in hospitalized patients with Influenza A infection~   "
81378|NCT01992263|"~     The goal of this study is to understand the effects of vitamin D supplementation on~     immunological outcomes among patients with tuberculosis.~   "
81379|NCT01992250|"~     This study examines the use of cryoablation as an alternative to surgery in the treatment of~     early stage invasive breast cancer. The hypothesis is that cryoablation will complete~     ablation and destroy the tumor in a selected population of women who may otherwise be~     adequately treated with surgery.~   "
81438|NCT01991457|"~     The goal of this research is to test if the conditioning regimen, fludarabine and total body~     irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment~     regimen for ALL patients older than 40 years of age and/or younger patients with high risk~     medical conditions. The primary objective is to establish the efficacy of allo HCT in older~     ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also~     assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative~     FluTBI conditioning regimen.~   "
81380|NCT01992237|"~     With the perception that lung protective ventilation with regard to low tidal volume~     ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory~     distress syndrome) and that the development of new technical devices of extracorporeal lung~     assist systems with lower complication rates support establishment of lung protective~     ventilation strategies these systems are more and more frequently used. All critically ill~     patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane~     oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and~     higher mortality risk. Besides inflammation malnutrition is known as one of the main risk~     factors. Over and underfeeding should be prevented. However nutritional aspects of patients~     on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates~     induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in~     cardiac output and septic state are influencing energy metabolism but until now there is no~     tool for measuring energy expenditure in clinical routine for patients on ECLA/ECMO.~     Indirect calorimetry is a simple device only for patients without ECLA/ECMO system.~     Oxygenation and CO2 (carbon dioxide) elimination by the lung assist system can be calculated~     but is not implemented to clinical routine. The combination of indirect calorimetry and~     calculation of lung assist function at the same time would give us the chance to adapt~     nutrition rates to energy expenditure. This may prevent muscle wasting and weakness. This~     pilot study will include 40 participating patients during 8 month investigating nutritional~     therapy adapted to energy expenditure calculated by O2 and CO2 turnover rates in patients on~     ECLA or ECMO systems. The investigators aim is to describe a calculation to set nutrition~     targets in ECMO patients. Second the investigators will describe level of nutritional needs~     under consideration of different mechanical ventilation states. Third O2 consumption and CO2~     elimination will be used to estimate cardiac output.~   "
81381|NCT01992224|"~     Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most~     common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and~     intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And~     mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to~     initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and~     conventional MV, and we hypothesize that early MV may be a better treatment option.~   "
81382|NCT01992211|"~     The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability~     of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to~     evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.~   "
81383|NCT01992198|"~     Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate~     (meropenem) therapy,which one is better.~   "
81384|NCT01992185|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of vitiligo.~   "
81385|NCT01992172|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of atopic dermatitis.~   "
81386|NCT01992159|"~     The purpose of this study is to determine if the treatment increases bone mineral density in~     Japanese women with postmenopausal osteoporosis.~   "
81387|NCT01992146|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization.~      In the present study, investigators hypothesize that a high-dose target-controlled naloxone~     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a~     unilateral primary open groin hernia repair procedure. Investigators aim to show that latent~     sensitization is present in humans and is modulated by endogenous opioids.~   "
81388|NCT01992133|"~     Gestational Diabetes Mellitus (GDM) and vitamin D deficiency are related to insulin~     resistance and impaired beta-cell function, with heightened risk for future development of~     diabetes. The investigators hypothesize that vitamin D supplementation to women with~     previous gestational diabetes may improve glucose metabolism.~   "
81389|NCT01992120|"~     The primary objective of the proposed study will be to determine if a multi-modality~     teaching curriculum utilizing high-fidelity simulation and didactic lecture will result in~     sustained improvement by internal medicine residents in written knowledge and clinical~     performance when compared to residents receiving a curriculum utilizing only didactic~     lecture. The investigators hypothesis is that the addition of high-fidelity simulation to a~     traditional didactic lecture curriculum will result in sustained and superior written~     knowledge and practical performance when compared to a group receiving only didactic lecture~     on the same topic. Specifically, the investigators will be assessing internal medicine~     resident knowledge and performance in the area of sepsis in the hospitalized patient, and~     will shape the investigators teaching curriculum around this focus.~   "
81390|NCT01992107|"~     Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than~     4 years old to less than 18 years old.~   "
81391|NCT01992094|"~     Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and~     above.~   "
81392|NCT01992081|"~     This study will test two instruments to measure physical activity in COPD patients: A~     questionnaire and two small physical activity monitors .Patients will be randomized to~     either receive the telecoaching program in addition to usual care or only the usual care.~     Study will include around 510 patients in 5 countries in Europe.~   "
81393|NCT01992068|"~     The purpose of this study is to prospectively assess the feasibility of high-resolution~     manometry to identify radiation-induced changes in esophageal motility and contractility or~     function in patients undergoing radiation therapy for the treatment of locally advanced~     lung cancer.~   "
81439|NCT01991444|"~     Registry study to evaluate the predictive value of a comprehensive geriatric assessment with~     regard to the outcome of a transcatheter aortic valve Implantation.~      It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best~     suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80~     years) Patient. Possible participants are all Patient of 80 years or above for whom the~     implantation of a Edwards Sapien XT aortic valve is planned~   "
81440|NCT01991431|"~     This is an international multi-center, prospective, observational registry with consecutive~     patient enrollment intended to determine outcome Parameters within 30 days after transaortic~     transcatheter aortic valve replacement.~   "
81394|NCT01992055|"~     This Clinical Trial is a pilot study being conducted to study the impact of a specific~     cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with~     executive dysfunction and associated problems in everyday functioning. The intervention~     program will also include relaxation training and psychoeducation regarding brain injury on~     everyday functioning, emotional status, and executive functioning. Goal Management Training~     focuses on teaching individuals strategies to compensate for executive functioning deficits~     and is based on a theory of goal neglect resulting in disorganized behavior following~     frontal lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in~     everyday life. Given its goal-oriented emphasis, focus on individual everyday difficulties,~     and reports of improvements in self-reported executive failures and mood, GMT appears to be~     an ideal intervention treatment for individuals with executive and functional deficits.~      Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive~     impairment on daily functioning, rather than attempting to restore cognitive abilities, a~     reduction in subjective reports of psychological distress is anticipated. This hypothesis is~     consistent with existing literature revealing reduced reports of annoyance and executive~     difficulties on self-report inventories. Improvements on tests of sustained attention and~     visuospatial problem-solving, as well as small effects on additional measures of planning,~     are also anticipated.~   "
81395|NCT01992042|"~     This research study provides a novel opportunity to examine the intra-prostatic tumour~     inhibitory effects of statins in men with prostate cancer undergoing surgery.~   "
81396|NCT01992029|"~     The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression~     can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The~     investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and~     blood sample) collected in three control populations: definite ALS patients according to El~     Escorial diagnostic criterion, control patients without any neurological disease having an~     orthopedic surgery for shoulder disease, and control patient explored for peripheral~     neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity~     and/or progression rate of the motor neurons define as the progression rate of the~     Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.~   "
81397|NCT01992016|"~     This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography~     (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic~     procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease~     has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of~     glucose available for uptake by the scan.~   "
81398|NCT01992003|"~     The primary purpose of this study is to assess the accuracy of the newly released Masimo~     SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level~     analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood~     hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.~   "
81399|NCT01991990|"~     This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics~     effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and~     survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV)~     RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil~     kinetics data will be collected for all subjects up to Day 10 of the study. Following the~     last study visit on Day 10, all subjects will attend two further safety follow-up visits on~     Day 28 and Day 56.~   "
81400|NCT01991977|"~     This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission~     tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing~     radiation therapy. Comparing results of diagnostic procedures done before and during~     radiation therapy may help doctors predict a patient's response to treatment and help plan~     the best treatment.~   "
81401|NCT01991964|"~     The hypothesis of the study is that laryngeal US can accurately and reliably diagnose~     laryngomalacia in infants with congenital stridor.~      Stridor is a respiratory noise caused by partial obstruction of the large airways at the~     level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor~     is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold~     standard. However, FLB under sedation has some drawbacks as it requires venous access, use~     of sedative agents, may cause discomfort for the patient and is costly.~      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging~     technique. It allows for dynamic assessment of moving structures in an awake patient and the~     results can be easily displayed and recorded.~   "
81402|NCT01991951|"~     We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no~     difference in thromboembolic or bleeding events between patients with short term warfarin~     therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8~     weeks after procedure).~   "
81403|NCT01991938|"~     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR~     kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This~     clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2~     (Expansion). The purpose of this study is to evaluate the safety (including the recommended~     Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the~     anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how~     subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor~     biopsies (in consenting subjects), and blood samples.~   "
81404|NCT01991925|"~     Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality~     of life and the delivered quality of care in the hospital.~   "
81405|NCT01991912|"~     The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity~     .This is further magnified by the disease being more common in elderly with associated~     medical comorbidities and being usually global involving multiple levels.The purpose of this~     study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic~     Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.~   "
81441|NCT01991418|"~     In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge~     difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin~     reductase may be a warning markers in excised non-small lung cancers, serum activity of this~     enzyme may elevated before CT scan~   "
81406|NCT01991899|"~     It is a clinicaltrial Phase III , randomized, double -blind , 4-arm (390 each one):~      This study will include 1560 children and will use 3 batches of vaccine produced by Bio -~     Manguinhos with viral bulk of GSK combined measles , mumps and rubella applied in healthy~     children 12-15 months of age, and 01 batch of MMR to reference( GSK ), applied in healthy~     children aged 12-15 months old . The vaccine is administered as MMR 1st dose.~      Two hypotheses are tested :~        1. Consistency of production ( equivalence between batches )of 3 batches of vacines(TV1,~          TV2 , TV3 Bio- Manguinhos). Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro),~          ie, the measles, mumps and rubella in Brazil is as immunogenic and safe as the measles,~          mumps and rubella reference, already used in routine NIP (production~          Bio-Manguinhos/FIOCRUZ with viral concentrate, bulk, GSK).~           The MMR vaccine (Bio-TV) will have the same composition (vaccine strains) and the same~          method of production of MMR (TV-GSK): Wistar RA27 / 3 rubella, Schwarz strain of~          measles vaccine, and strain RIT 4385 - derived from the Jeryl Lynn strain of mumps~          vaccine.~           As 2nd dose, children receive the vaccine tetraviral measles-mumps-rubella-varicella,~          aged 15-18 months, according to the guidance of the National Immunization Program.~        2. Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro):the measles, mumps and rubella~          vaccine in Brazil is as immunogenic and safe as the measles, mumps and rubella~          reference, already used in routine NIP (production Bio-Manguinhos/FIOCRUZ with viral~          concentrate, bulk, GSK).~      Returns for blood sampling will be scheduled for 51 days, ranging from 42 to 60 days after~     dose of MMR vaccine dose and after tetraviral. We will colect the firt blood sample before~     the first vaccination too.~      It will describe the major adverse events observed after vaccination , comparing their~     frequency in groups of MMR vaccine with the Brazilian reference vaccine .~   "
81407|NCT01991886|"~     Recent large studies have shown that not all premature babies need to be intubated (have a~     breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant~     routinely. Those studies showed that even very small babies can be safely supported using~     nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using~     nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to~     breath, albeit with additional support to reduce their work of breathing. However nCPAP has~     some drawbacks, including that it can cause skin damage to the nose, and that the heating~     and humidification of the gas is not always sufficient. We have been using, for over 5~     years, a different system to support babies after routine intubation. This is another type~     of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm~     Precision Flow device. Published trials show that it is at least as effective as nCPAP to~     provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF~     is superior to nCPAP in respect it does not cause nose damage and its heating and~     humidification is excellent. This pilot study aims to describe and evaluate the use of nHF,~     using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth,~     in babies born less than 30 completed weeks gestation, with a view to avoiding intubation~     and ventilation. This study is important to establish the feasibility of using nHF~     immediately after birth.~   "
81408|NCT01991873|"~     This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate~     the progression-free survival during maintenance therapy.~      Eligible patients will be treated within a 12-week induction therapy. Those patients~     achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction~     treatment with all potential drug components, will be randomized in a ratio of 1:1 to~     receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of~     progression, re-induction treatment will be started.~   "
81409|NCT01991860|"~     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at~     moderate-to-high risk of PONV.~   "
81410|NCT01991847|"~     The purpose of this study is to determine the feasibility of a one year exercise training~     program in post-surgical patients with colon cancer.~   "
81411|NCT01991834|"~     Laparoscopy is a surgical procedure indicated for most gynecological pathologies and~     presents numerous advantages over laparotomy, among them lower rates of surgical site~     infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is~     widely accepted and performed by most gynecologists. However, there isn't literature~     evidence to support the routine use of antibiotics in the prophylaxis of wound infection on~     laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of~     antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.~   "
81412|NCT01991821|"~     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at~     moderate-to-high risk of PONV.~   "
81413|NCT01991808|"~     This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and~     after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial~     cancer.~   "
81414|NCT01991795|"~     The purpose of this study is to compare the effect of ticagrelor versus placebo in patients~     with Type 2 Diabetes Mellitus.~   "
81415|NCT01991782|"~     The purpose of this study is to determine whether telemedicine video calls for follow-up~     visits between patients and their orthopaedic trauma surgeons has an impact on patient~     satisfaction, quality of life, and treatment adherence. This study will also assess the~     feasibility of telemedicine as a medium for follow-up visits.~   "
81416|NCT01991769|"~     The purpose of this study is to examine whether exercise reduces the postprandial effects of~     an unhealthy meal on heart function and endothelial function.~      Both healthy people and type 2 diabetes subjects will during three days either carry out two~     different sessions of exercise training or not before ingesting an unhealthy meal high in~     saturated fat and fast carbohydrates. The two different exercise training modes used are~     high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis:~     Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac~     function in healthy and type 2 diabetes individuals. HIIT will reduce the negative~     postprandial effects on the endothelium more than MIT.~   "
81417|NCT01991756|"~     The primary objective of the study is to evaluate the acute safety of deploying and~     implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for~     endovascular repair.~      Secondary objectives are to evaluate the acute and longer-term safety and performance of the~     Altura Endograft through 5 years.~   "
81418|NCT01991743|"~     We plan to conduct a prospective, single blinded, randomized clinical trial to assess the~     impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction~     during, external version for breech fetal position and the incidence of vaginal vs. Cesarean~     delivery.~      The research aim of this project is to determine the ideal neuraxial dosing strategy to~     maximize success of external cephalic version (ECV).~      The research questions, does a combined spinal-epidural (CSE) of a higher dose result in~     greater success in converting a breech presentation to vertex during external cephalic~     version (ECV).~      The hypotheses of this project is that CSE at higher dose will result in greater ECV success~     than analgesic dosing.~      The research significance:Increasing the success and comfort of ECV for fetal~     malpresentation may help decrease the cesarean section rate.~   "
81419|NCT01991717|"~     Cataract surgery is among the world's most frequently performed operations. It involves~     removal of an opaque lens from the human eye and implantation of an artificial lens. The~     operation is performed under local anaesthesia using ultrasound technology, by which the~     lens is emulsified and removed by suction.~      Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can~     improve the quality of cataract surgery and provide a new best possible standard of quality.~     In contrast to the conventional method the capsulotomy and the fragemntation are fully~     automatically performed with a femtosecond laser. In addition, the lens is fragmented by the~     laser, which substantially facilitates its removal and reduces the operation time.~      Study to investigate whether the femtosecond laser cataract surgery causes any significant~     differences in clinical outcomes as compared to the conventional, manual continuous~     curvilinear capsulorhexis (CCC).~      Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline~     lens.~      EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at~     intraoperative visit~   "
81420|NCT01991704|"~     In order to determine whether the 'incubation of craving' phenomenon also occurred in~     alcoholics, investigators employed an experimental approach to investigate the time course~     of cue-induced craving in alcoholism. Eighty male participants were randomly divided into~     Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced~     alcohol craving . Another group including 19 patients was repeatedly tested for the~     cue-induced alcohol craving at the above abstinence days. Other psychological and~     physiological measures were administered at the four abstinence time points.~   "
81421|NCT01991691|"~     This study is a single arm feasibility study. Patients that have been diagnosed with~     carcinoma and are undergoing chemotherapy have to document chemotherapy associated side~     effects on a regular basis by means of a tablet-based online questionnaire. Goal of the~     study is to find out if patients that are undergoing chemotherapy are willing to document~     chemotherapy associated side effects by means of a tablet-based online questionnaire.~   "
81422|NCT01991678|"~     The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with~     mild, moderate, or severe hepatic impairment.~   "
81423|NCT01991665|"~     A failed operative vaginal delivery is associated with increased risk of maternal and~     perinatal complications. It is very important the determination of the fetal head position~     prior to instrumental delivery.~      Generally,diagnosis of the fetal head position is made on transvaginal digital examination~     by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity~     of studies on the accuracy of digital examination but the general consensus is that~     reproducibility is low and diagnostic uncertainty remains high even for operators with much~     experience.~      As the traditional clinical evaluation has many limitations, a new tool capable of~     increasing diagnostic objectivity and accuracy would be of great interest.~      The aim of our study was to evaluate, in a prospective study, if the complementary use of~     ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may~     play a role in labor outcome.~   "
81424|NCT01991652|"~     Significant progress has been made in the treatment of Wilms tumor in high income countries,~     where survival is now around 85% - 90%. Survival in low income countries is much lower;~     specific challenges include late presentation, malnutrition, less intense supportive care~     facilities and failure to complete treatment.~      A comprehensive treatment guideline was introduced in Malawi in 2006 which included~     nutritional support and social support to enable parents to complete treatment. Survival has~     increased to around 50%; 95% of children completed their treatment. A multi-disciplinary~     group of African clinicians and 'state of the art' experts produced a consensus treatment~     guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be~     implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes,~     expecting about 200 new patients per year.~      The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete~     treatment and <10% treatment related mortality. Other research questions include efficacy~     and toxicity of preoperative chemotherapy and the comparison of surgical staging, local~     pathology and central review pathology in stratifying postoperative chemotherapy.~   "
81425|NCT01991639|"~     Background: In elderly subjects frailty and malnutrition are very common and can lead to~     serious health hazards, increase mortality, morbidity, dependency, institutionalization and~     a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are~     increasing steadily and are becoming a challenge for our social system. Physical training~     and adequate nutrition can invert it.~      Methods/Design: In this randomized, controlled trial 80 malnourished, frail,~     community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥~     50 years) named buddies are recruited and subsequently trained regarding health enhancing~     physical activity and nutrition in three standardized training sessions. These buddies visit~     the malnourished, frail subjects at home twice a week for about one hour during an initial~     period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct~     intervention to improve their fluid intake, their protein and energy intake, perform~     strength training and try to increase their baseline activities, the control group (n=40)~     only gets home visits without any special intervention. After 10-12 weeks, both, the~     intervention and the control group, receive the nutrition intervention and the physical~     training. Health, nutrition and frailty status, physical fitness and body composition and~     chronic inflammation of buddies and frails are recorded before the intervention, after 10-12~     weeks, and after 6 and 12 months.~      Discussion: To the investigators knowledge this trial is the first of its kind to provide~     nutrition and physical activity intervention to malnourished, frail, community-dwelling~     subjects by trained lay buddies, in which the health status of buddies is also expected to~     improve. This study assesses the effectiveness of such an intervention. If successful, the~     intervention offers new perspectives for the management of frailty and malnutrition.~   "
81426|NCT01991626|"~     Previous studies on iron absorption have focused on the effects on the addition of iron~     absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic~     phytic acid removal through phytase. The investigators want here to investigate the effects~     of fat on iron absorption with and without the addition of exogenous phytase as a potential~     iron absorption enhancer in lipid nutrient supplements (LNS) products compared to~     micronutrient powder(MNP) products.~      Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to~     induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the~     caloric density of a meal by increasing its fat content might enhance iron absorption by~     delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.~   "
81427|NCT01991613|"~     We hypothesize that premature infants who receive their mothers' expressed breast milk~     supplemented with liquid protein early in their hospitalization will have a growth velocity~     in the first 28 days of life that is 20% greater than the growth velocity of premature~     infants that do not receive protein fortification.~   "
81428|NCT01991600|"~     Iron deficiency is the most common micronutrient deficiency in the world today, affecting~     more than 60% of the global population (www.who.int/nut/ida.htm). The two main strategies~     for the prevention and treatment of iron deficiency involve fortification of food with iron,~     or direct supplementation with iron tablets. Simple iron salts (e.g. ferrous sulphate) are~     well absorbed but at supplemental levels (and potentially at lower levels, as used in food~     fortificants) can induce free radical activity resulting in gastrointestinal side effects~     and systematic oxidative stress. As a result, supplementation has poor compliance and~     improvement in iron status is compromised. Ferric salts are less inclined to produce side~     effects and although they are relatively well absorbed at fortification levels in food, they~     are poorly absorbed at the higher supplemental doses. Because certain components of food,~     such as organic acids, can facilitate ferric iron absorption, we now wish to determine~     whether dietary organic acids may similarly enable efficient absorption of supplemental~     ferric iron while preventing the formation of non-transferrin-bound iron (NTBI) which is a~     proxy for free radical activity. Our strategy is to use an iterative process between in~     vitro and in vivo experimentation, aimed at identifying the best choice of organic acid and~     the optimal ratio of iron:organic acid. The study was a cross-over, single-dose comparison~     against standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic~     women. Both the investigational products and the active comparator were administered as a~     single dose on 2 different occasions, i.e. the investigational products on the first study~     visit and the active comparator 14 days later on the second study visit.~   "
81429|NCT01991587|"~     A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging,~     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a~     single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine~     administered to healthy adults 18-49 years of age.~      A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30~     subjects to receive one injection of either a low, a medium, or a high dose level of VLP of~     the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM)~     phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).~   "
81430|NCT01991574|"~     Ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary~     organic acid that was developed at MRC Human Nutrition Research. We aim to determine if the~     ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate~     concentration, compared with the administration of placebo plus the same food on a different~     occasion. We hypothesise that ferric hydroxide adipate binds some phosphate ions in the~     gastrointestinal tract, which prevents part of the phosphate load in a meal from being~     absorbed. On another visit, calcium will be given with the same food, as a positive control,~     since this element is well known to restrict dietary phosphate absorption through the~     formation of insoluble calcium phosphates in the gut lumen. We will compare urinary~     phosphate concentrations after co-ingestion of the calcium salt and food versus urinary~     phosphate following ferric hydroxide adipate and the same food. Additionally, the calcium~     data will be compared with placebo data, since a significant reduction in urinary phosphate~     concentrations after calcium treatment will confirm the suitability of the study design.~      Finally, iron absorption from the ferric hydroxide adipate treatment will be determined by~     labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.~      The study design is: Three-way cross-over volunteer absorption study. Volunteers will not be~     told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental~     calcium). Researchers co-ordinating the study on a day to day basis will be aware of~     treatment allocation, but analysts will not be told which samples correspond to which~     treatments.~   "
81431|NCT01991561|"~     A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the~     Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine~     adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE),~     in healthy adults 18-60 years of age.~   "
81432|NCT01991548|"~     This four center international study will include two United Kingdom National Health Service~     centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate~     subject acceptance of a new insulin pump and transmitter together with the accompanying~     training materials. Descriptive data from participant questionnaires and device uploads will~     be evaluated.~      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of~     age upwards, who currently use an insulin pump in the management of their type 1 or type 2~     diabetes, will be invited to participate. Each subject will be trained on the study device~     and then use it for approximately four weeks. During this time there will be three in-clinic~     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of~     this period, they will revert back to their original insulin pump and complete a~     questionnaire on the study pump training materials, features and usability.~   "
81433|NCT01991535|"~     The purpose of this study is to determine whether breathing pattern (specifically the~     inspiratory time/total respiratory cycle value) has an influence over the response to the~     noninvasive mechanical ventilation.~   "
81434|NCT01991522|"~     Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning~     colonoscopy typically learn the procedure experientially but simulation based teaching is~     increasingly being integrated into training programs. The optimal manner to teach~     colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in~     simulation-based colonoscopy with self-directed learning on simulators.~   "
81435|NCT01991509|"~     The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101~     when administered intravenously or subcutaneously to healthy volunteers.~   "
81436|NCT01991483|"~     This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in~     hemodialysis participants. This study will involve multiple doses of LY2928057 given during~     a 6 week period either after a participant discontinues or reduces treatment to stimulate~     red blood cells. This study will last up to 26 weeks for each participant.~   "
81437|NCT01991470|"~     The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance~     in pediatric patients with insulin requiring diabetes at the beginning, middle and end of~     sensor wear.~   "
87815|NCT01907906|"~     The purpose of this study is to evaluate radiolabeled recovery and survival of autologous~     red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as~     leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects~   "
81442|NCT01991405|"~     Background:~      Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe~     than normal cognitive changes due to old age, and less severe than dementia. Reduced working~     memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have~     indicated that WM can be improved trough computer based training.~      Objectives:~      The objective of the study is to evaluate if working memory training is effective in~     improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training~     relates to structural changes in the white and gray matter of the brain, assessed by~     structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and~     progression to dementia will also be investigated.~      Patients and Methods:~      The proposed study is a blinded, randomized and controlled trail that will include 90~     elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to~     either training or a placebo version. The intervention is computerized working memory~     training performed for 45 minutes over 25 sessions. Neuropsychological assessment and~     structural MRI will be performed before, 6 and 12 months after training.~      Relevance:~      Currently there is no known treatment available for mild memory impairment/MCI, and few~     studies on specific cognitive training in MCI-patients have been performed. The proposed~     study has received funding from a Norwegian Health Region. If computer based training~     results in positive changes to memory functions in MCI patients this may represent a new,~     cost-effective treatment. Secondly, evaluation of training induced structural changes to~     grey or white matter may improve our understanding of the mechanisms behind effective~     cognitive interventions in MCI patients.~   "
81443|NCT01991392|"~     Nasogastric decompression was routinely used in most major intra-abdominal operations.~     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,~     and gastric distension). Would and respiratory complications, and to reduce the incidence of~     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric~     decompression following elective abdominal surgery has been increasingly questioned over the~     last several years. Many clinical studies have suggested that this practice does not provide~     any benefit but could increase patient discomfort and respiratory complications.~     Furthermore, meta-analyses have concluded that routine nasogastric decompression is no~     longer warranted after elective abdominal surgery.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery.However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy. In spite more and more studies reported of no need of nasogastric tube after~     abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of~     lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy~     include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive~     destruction and potential risk of gastric stasis after PD. However, our pilot study of~     retrospective analysis of postoperative NG drainage amount in 100 patients recently having~     PD at our hospital showed more than 90% of patients had less than 200cc/day NG drainage~     amount within postoperative day three. Theoretically, these patients might not need a~     nasogastric tube after pancreaticoduodenectomy. Therefore, investigators propose a~     prospective multicenter randomized trial to assess the need of a nasogastric tube after PD.~   "
81444|NCT01991379|"~     The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and~     imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST).~   "
81445|NCT01991366|"~     The aim of this observational study is to evaluate the in hospital and 6 month outcomes of~     the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients~     undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction~     in a large tertiary referral center.~      It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous~     Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is~     superior to unfractionated heparin alone or bivalirudin alone. Additionally, after~     propensity matching this superiority remains.~   "
81446|NCT01991353|"~     This study will compare meniscal healing with or without platelet rich plasma. The~     assessments will include validated, disease specific, patient oriented outcome measures, MRI~     arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal~     healing rates.~      Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.~   "
81447|NCT01991340|"~     This observational study will assess the safety of Herceptin (trastuzumab) in patients with~     HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed~     for up to 4 years.~   "
81448|NCT01991327|"~     The primary objective of this study is to assess the drug-drug interactions of Androxal with~     cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy~     male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and~     tolerability of Androxal will be determined in healthy male subjects administered Androxal~     25 mg daily for 3 days.~   "
81449|NCT01991314|"~     Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least~     20% patients at any one time. Hepcidin, a recently described anti-microbial peptide~     synthesized by the liver, is a key regulator of iron homeostasis. It interferes with~     absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin.~     Hepcidin levels rise when total body iron levels rise and protect against iron overload;~     conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the~     influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient~     erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy~     in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients~     who are anaemic report quality of life and fatigue scores comparable to those seen in~     malignancy.~      IBD diagnosed in adolescence interferes with growth, education and employment as well as~     psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high~     prevalence of psychological distress, particular depression. Limited historical, and our own~     data suggest that children and adolescents with IBD are more anaemic than adults, and less~     often treated with oral iron. What is not clear is whether the apparent under-utilisation of~     oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns~     about possible side effects including worsening disease activity.~      To address these questions, the investigators propose a comparative study of 6 weeks of oral~     iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients~     will be given oral iron supplementation. Before and after iron therapy, the investigators~     shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived~     stress, mood and fatigue; iron metabolism, including serum hepcidin.~   "
81450|NCT01991301|"~     The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a~     novel biological agent used in the treatment of multiple myeloma in preventing~     graft-versus-host disease, after stem cells transplantation from unrelated donors.~   "
81451|NCT01991288|"~     We hypothesize that preoperative saphenous nerve block (SNB) in combination with~     periarticular local infiltration provides better post operative pain relief (POPR) profile~     as compared to local infiltration alone~   "
81452|NCT01991275|"~     This study will investigate the efficacy and safety of intrathecal morphine for the patients~     undergoing robot-assisted prostatectomy~   "
96927|NCT01788371|"~     To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of~     the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with~     high level of HBV DNA.~   "
81453|NCT01991262|"~     Protocol Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an~     Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B~     Viral Infection~      Objective(s): The primary objectives of the study are to assess:~        -  HBV treatment adherence rate in patients enrolled in the Support Program~        -  Adherence rates at 6m, 12m.~      The secondary objectives are to assess:~        -  Adverse events rate and profile.~        -  Actual treatment duration and dose taken vs. prescribed.~        -  The impact of SMS reminders.~      Study Design: Eligible patients will be randomized into one of four groups: Group 1 shall~     receive both a weekly phone call from a supporter and a daily SMS reminder. Group 2 will~     receive a weekly phone call only. Group 3 will receive a daily SMS reminder only and group 4~     (Control) shall receive no support.~      Study Population: Adult newly diagnosed with Hep B patients, eligible to begin treatment~     with first line therapy.~      Data Collection Methods:~        1. Supporter's documentations of patient's self assessment.~        2. Drugs dispense data from pharmacies~        3. Pills count.~   "
81454|NCT01991249|"~     Acute leukemias are a heterogeneous group of hematologic malignancies. They result from~     clonal expansion of immature cells whose number is greater than 20% in bone marrow.~     Childhood acute leukemias are the most common pediatric malignancies. In Europe and the~     United states, they represent about 35% of childhood cancers. 80% of them are acute~     lymphoblastic leukemia (ALL) and 15-20% of acute myeloid leukemia (AML). Current treatments~     allow a cure in about 80% of ALL, while this level is only 50% in AML.Acute leukemia~     diagnosis is based on the multidisciplinary exploration of leukemia cells by different~     techniques:~        -  Cellular: cytology, immunophenotyping and cytochemistry~        -  Cytogenetic: conventional (karyotype) and molecular (FISH) cytogenetic~        -  Molecular: RT-PCR and RQ-PCR~      Cytogenetic studies are performed at time of acute leukemia diagnosis. Indeed, the WHO 2008~     classification of acute leukemia is based largely on the presence of recurrent cytogenetic~     and molecular abnormalities. The most frequent chromosomal aberrations have been associated~     with specific clinical and biological characteristics and are now used as diagnosis and~     prognostic markers. These chromosomal abnormalities affect genes involving in the~     leukemogenesis process. These rearrangements are of several types:~        -  Fusion genes causing :~             -  Repression of transcriptional activity of genes involved in differentiation of~               hematopoietic cells (AML1-ETO, PML-RARA…)~             -  Deregulation of signal transduction pathway (eg BCR-ABL chimeric protein with~               constitutive tyrosine kinase activity)~             -  Changing in the state of chromatin condensation resulting changes of transcription~               (MLL gene rearrangements in 11q23, MOZ en 8p11…)~        -  Deregulation of genes expression: chromosomal rearrangements can sometimes induce~          deregulation of adjacent genes to the breakpoint. For example, inv(3)(q21q26) or~          t(3;3)(q21;q26) induce over expression of transcriptional factor EVI-1.~        -  Loss of function due to deletion of variable size in genomic regions containing genes~          with a role in the differentiation, apoptosis, or cell proliferation (eg IKZF1, PAX5…)~      In addition to the karyotype, which allows to have a global view of the genome; FISH, a~     targeted technique, is used to highlight invisible abnormalities on karyotype (cryptic~     abnormalities) or the time of karyotype failure. However, conventional and molecular~     cytogenetic techniques do not highlight any abnormalities (eg different partners involved in~     the formation of fusion genes in particular for MLL gene rearrangement, mutations) hence our~     interest in next generation sequencing.Indeed, the high throughput targeted sequencing~     messenger RNAs (RNA-seq) has the avantage of allow identification of different types of~     mutations in a single test, with exception of epigenetic mutations. The importance of RNAs~     sequencing rather than DNA genomic is the one hand, a very significant decrease in the~     volume of sequences to analyze because transcribed mRNA genes represent about 5% of the~     genome size and secondly, a better identification of chimeric genes. The RNA-seq has used as~     a research tool in hematologic malignancies. The purpose of this project is to use~     innovative technology to develop a new diagnostic and prognostic new tool in hematological~     malignancies. 50 acute leukemias will be tested and results will be analyzed according to~     three criteria:~        -  Quantity, quality and relevance of information provided for the diagnosis, monitoring~          and therapeutic management compared to a conventional strategy~        -  Period required to obtain results and methods to decrease the analysis time so that~          results can be integrated into therapeutic decisions.~        -  Economic evaluation, which will calculate the cost of this diagnosis option and assess~          the cost/benefit ratio In future, other innovative approaches will be implemented~          (study of imbalances genomic abnormalities by array-CGH, transcriptome analysis with~          micro-array, and study of methylome) to identify the molecular signature of each~          leukemia and set of informative abnormalities for diagnosis, prognosis and treatment of~          disease and monitoring of residual disease.~   "
81455|NCT01991236|"~     1.0 Title: The Efficiency and Effectiveness of Video-Based Education for Dermatology~     Patients Qualifying for Chronic Treatment with Systemic Corticosteroids~      2.0 Background: Past studies have shown that the use of educational videos has been~     effective in increasing patient education and satisfaction. These studies suggest that such~     video tools may enable an office to be significantly more efficient.~      3.0 Objective: The Emory University Department of Dermatology has created an educational~     video as part of clinical care. The objective for Phase I of the study is to collect~     information about dermatology patients' baseline knowledge about corticosteroid and/or~     corticosteroid sparing medication treatment using an online (or written copy) questionnaire.~     The objective for Phase II of the study is to determine the effect of a video on dermatology~     patient knowledge. The objective for Phase III of the study is to determine the office~     efficiency of the video in patients requiring long-term oral corticosteroid and/or~     corticosteroid sparing medications. Secondary objectives of the study are to determine~     patient and physician satisfaction with the video as an educational tool.~      4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a~     participating physician's clinic day at the Emory Dermatology Department. Phase III:~     Patients who require treatment with long term oral corticosteroids at the Emory University~     Department of Dermatology Clinic as determined by their treatment physician.~      5.0 Recruitment: All patients arriving to clinic on a study day will be given an~     informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II:~     (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only~     patients who require long term oral corticosteroid treatment will proceed to Phase III: of~     the study. Physicians will be recruited from the Emory Dermatology Department.~      6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online~     (or a written copy). Their results will be compared with baseline results from patients in~     Phase III: who undergo treatment with steroids. Patients in Phase II or III will be~     randomized to two groups. Control patients will receive verbal discussion of corticosteroid~     treatment. Phase II control patient education will be using a script developed by study~     physicians and delivered by study personnel. Phase III patients who qualify for long term~     systemic steroid will have verbal education by their doctor as usual. Video patients will~     receive an educational video instead, and will write down any remaining questions after~     viewing for their doctor to address as soon as possible. After verbal or video education,~     both groups will take a post-education questionnaire and patient satisfaction surveys~     online. Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3,~     and 6 months after beginning treatment. At follow-up, their doctor will ask about current~     corticosteroid dose and frequency, willingness to transition to a steroid-sparing method,~     and compliance with preventative measures during treatment. Patients will complete the same~     post-education questionnaire online again at these visits. Physicians will also complete~     satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months.~      6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient~     completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase~     II of this study (40 per group).~      6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes~     Physicians: 20 minutes~   "
81456|NCT01991223|"~     To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder~     discomfort~   "
81457|NCT01991210|"~     This randomized, multicenter, open-label study will evaluate the safety and efficacy of~     DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal~     cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A~     2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams~     per meter-squared (mg/m^2) IV every 4 weeks.~   "
81458|NCT01991197|"~     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves~     psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and~     type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20~     participants treated with Januvia® to 20 participants treated with 16 weeks of a comparator~     drug (gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4~     week washout period will be followed prospectively for 36 weeks. Participants will be~     stratified by centre, psoriasis severity and obesity status after which they will be~     randomly allocated to Arm A or Arm B. Participants will be treated with either Januvia® and~     Diamicron® matched placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo~     tablets (Arm B) for 16 weeks and then proceed to an open-label phase where all participants~     will receive Januvia® for a further 16 weeks.~      Both the research participants and the investigators will be unaware of the trial arm to~     which the research participant has been allocated (double-blind study). Research~     participants will be prohibited from making any changes to the dose of medications used to~     treat psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a~     participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks~     after commencing one of the study investigational medicinal products (IMPs) insulin therapy~     will be used to improve glycaemic control.~      Participants will be assessed at 9 study visits over 40 weeks. Participants will complete~     questionnaires, have a medical history recorded and physical examination, blood sampling and~     skin biopsies taken (in a small number of willing participants at 3 visits).~      The following endpoints will be analysed:~      Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life~     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,~     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles;~     changes in cytokines, hormones, expression of immune proteins in blood and skin biopsies;~     and genetic profiles that predicts best response to sitagliptin therapy.~      We hypothesize that sitagliptin therapy decreases psoriasis severity.~   "
81459|NCT01991184|"~     This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics~     of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's~     lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be~     assessed in subsets of patients.~   "
81460|NCT01991171|"~     Forty-eight female patients will be randomized into three groups to receive the Kinesio~     taping, placebo Kinesio taping and control group. The group Kinesio taping receive the~     correct application of the method described. The placebo group will receive a placement~     without tension. The control group did not receive any form of intervention.~   "
81461|NCT01991158|"~     The purpose of this study is to evaluate the efficacy and safety of High dose of~     Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as~     first-line treatment in patients with de novo extranodal NK/T cell lymphoma.~   "
81462|NCT01991145|"~     This randomized controlled study aims to evaluate the efficacy and safety of allogeneic~     umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.~   "
81470|NCT01991041|"~     This is a registry study, where sites will enter patients with LGS who require a~     modification in anti-epileptic therapy (either the addition of another anti-epileptic drug,~     or the change of one drug to another). This will include patients who are started on~     rufinamide. Patients will be reviewed according to local practice, but it is envisaged that~     review will occur at approximately one month, three months and six months, and then every~     six months. Upon entry to the registry baseline details concerning disease severity,~     diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent~     visit the patient (usually through their caregiver) will be asked about current medication,~     general seizure profile, any seizures deemed to be of medical significance, tolerability,~     AEs (including suicidal-related events), and healthcare resource utilisation.~   "
81463|NCT01991132|"~     Non-contact meibography is a useful tool in assessing the health of meibomian glands in~     patients. Instead of using normal light in contact meibography, non-contact meibography~     utilises infra-red (IR) light. IR light is shined on patients' inverted eyelids and a~     special camera then allows visualisation of the structure of the meibomian glands, including~     the ducts and acini. Currently, images taken via non-contact meibography are manually~     analysed by a skilled clinician.~      Knowledge of the health of meibomian glands is useful, especially in the diagnosis of~     Meibomian Gland Dysfunction (MGD). Studies have shown that MGD is one of the most common~     causes of evaporative dry eye.~      Mediview 2.0 is a software that has been programmed to semi-automatically classify~     meibograph images taken via non-contact meibography. This software is collaboration with~     Shanghai MediWorks Precision Instruments Co., Ltd. The algorithm used was developed by a~     collaboration between Agency for Science, Technology and Research (A*STAR) and Singapore Eye~     Research Institute (SERI).~      This current study aims to validate the diagnostic accuracy of Mediview 2.0 in assessing the~     health of meibomian glands of patients, against a trained clinician. We aim to recruit 100~     participants for this study.~      Once this software is found to be valid, a trained technician could be taught how to capture~     the images and hence leaving the doctors with more time to focus on clinical assessment and~     treatment instead. Therefore, this study has the potential to increase efficiency in the~     clinics.~   "
81464|NCT01991119|"~     the purpose of this study is to compare the ability of propafenone and dronedarone to~     maintain sinus rhythm after DC cardioversion~   "
81465|NCT01991106|"~     The prevalence of paediatric obesity has increased over the last two decades and with it, an~     increased diagnosis of lifestyle-related diseases in children and adolescents. High~     intensity interval training has recently been explored as an alternate to traditional~     aerobic exercise in adults with chronic disease and has potential to induce rapid reversal~     of subclinical disease markers in obese children and adolescents.~      High intensity interval training has recently been explored as an alternate to traditional~     aerobic exercise in adults with chronic disease and has potential to induce rapid reversal~     of subclinical disease markers in obese children and adolescents.~      Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness~     of a high intensity interval training intervention on myocardial function, vascular function~     and visceral adipose tissue in obese children and adolescents at baseline, three and twelve~     months.~      Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in~     the cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised~     to (1) high intensity interval training, (2) moderate intensity continuous training or (3)~     nutrition advise. Participants will partake in supervised exercise training and/or nutrition~     consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3~     months (post intervention) and 12 months (follow up).~      Scientific Significance : This randomised controlled trial will general substantial~     information regarding the effects of exercise intensity on paediatric obesity, specifically~     the cardio-metabolic health of this at-risk population. It is expected that communication of~     results will allow for more robust and realistic guidelines regarding exercise prescription~     in this population to be formed while outlining the benefits of high intensity interval~     training on subclinical markers of disease.~   "
81466|NCT01991093|"~     Antiplatelet therapy with aspirin-clopidogrel reduces the risk of cardiovascular episodes~     after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes.~     However, a significant number of patients experience recurrent events while on such therapy.~     The individual response to dual antiplatelet therapy is not uniform, and consistent findings~     across multiple investigations support the association between a lower degree of platelet~     inhibition, high on-treatment platelet reactivity, and the occurrence of atherothrombotic~     events [1, 2]. Particularly in diabetic patients, clopidogrel resistance is more prevalent~     compared with non-diabetics [3,4], which seems to contribute to the increased~     atherothrombotic risk in these patients compared with those without diabetes mellitus (DM)~     [5]. A number of platelet function instruments have now become available that are simple to~     use and can be utilized as point-of-care (POC) instruments in order to monitor antiplatelet~     therapy and potentially assess the risk of a recurrent event [6].~   "
81467|NCT01991080|"~     The immune system plays an important role in the fight against cancer. According to certain~     studies, Levels of cytokines secreted by the immune cells were found as predictors of~     prognosis and survival among cancer patients, as well as disease recurrence. Previous~     studies, including meta-analyses, reported that chronic emotional stress or depression were~     associated with higher levels of pro-inflammatory cytokines. Practicing relaxation was found~     to decrease psychological symptoms among cancer patients, such as depression, anger,~     hostility and anxiety symptoms, as well as physical symptoms.~      Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum~     aestivum). Currently, there are only a few laboratory and medical studies that examine the~     beneficial effects of wheatgrass consumption. Controlled clinical trials have found that~     wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and~     infection without harming the chemotherapy effectiveness among breast cancer patients6.~      Aims~        1. To examine the differences in immune measures (serum and micro-particles levels of the~          cytokines IL-6, IL-8, IL-10 and IL-12), and in physical and psychological well-being~          measures (anxiety, depression, pain, fatigue, nausea) at three time points and between~          two intervention methods (biofeedback-assisted relaxation and wheatgrass consumption)~          and between the intervention groups vs. a control group, among colorectal cancer~          patients.~        2. To assess the mediating role of optimism, perceived control and well-being measures~          (anxiety, depression, pain, fatigue, nausea) among colorectal cancer patients in the~          relations between the interventions (biofeedback-assisted relaxation and wheatgrass~          consumption) and the immune measures (serum and micro-particles levels of cytokines~          IL-6, IL-8 IL-10 and IL-12 ), and the mediating role of well-being measures on the~          relations between optimism and perceived control with immune measures.~      Methods Participants will include 120 colorectal cancer patients aged 18+, with Eastern~     performance status of ≤ 2 and disease stage II or III, who receive adjuvant chemotherapy of~     Capcitabine or FU-5 treatment, conjoined with Oxaliplatin, or Capcitabine alone following~     curative surgery at Rambam Health Care Campus. The estimated number of participants was~     calculated based on Green's equation (1991): 50+8X 7 A comparison between the two treatment~     groups, as well as a comparison between each treatment group and the control group (80~     subjects) will allow inclusion of up to four background parameters in each of the~     regressions, according to Green's equation.~   "
81468|NCT01991067|"~     Patients undergoing allogeneic blood and marrow transplantation (HSCT) experience a~     prolonged period of dysfunctional immunity. Systematic reimmunization is necessary at~     appropriate time intervals following transplantation to re-establish immunity. Vaccination~     practices after HSCT remain varied and data sparse. Tick-borne encephalitis (TBE) is one of~     the most severe infections of the central nervous system caused by a tick-borne flavivirus.~     There is no specific treatment, and prevention with the vaccine is the only intervention~     available. To assess the efficacy of TBE vaccination in adult allogeneic HSCT recipients~     compared to an age-matched and sex-matched control group of healthy volunteers without~     previous TBE vaccination, a prospective open-label phase II pilot study on humoral and~     cellular immune responses after use of TBE vaccine (FSME Immun) will be performed. As~     primary end point the outcome of the neutralization test (NT) against TBE will be assessed~     in a total of 26 HSCT patients one year after HSCT and in 26 healthy volunteers, namely four~     weeks after the second vaccination. Therefore, the number of subjects with NT titres against~     TBE virus >10, assumed to be the threshold for antibody-mediated protection will be~     evaluated. As secondary endpoints, antibody concentrations of TBE enzyme-linked~     immunosorbent assay before and four weeks after the second and third vaccination and~     antibody concentrations of NT against TBE four weeks after primary immunization. To evaluate~     cellular immune responses, lymphocyte proliferations assays and cytokine detection assays~     will be performed. In a subgroup analysis, these secondary endpoints will be compared~     between healthy volunteers, HSCT patients without immunosuppressive treatment and HSCT~     patients receiving immunosuppressive agents. Additionally, immune reconstitution by analysis~     of peripheral blood lymphocyte subsets and serum immunoglobulin levels will be evaluated~     prior to vaccination, after twelve weeks and prior to the third vaccination in HSCT patients~     only.~   "
81469|NCT01991054|"~     Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health.~     There is accumulating evidence linking deficient vitamin D status with both type 1 and type~     2 diabetes.~      The purpose of this study is to evaluate the effect of high dose vitamin D supplementation~     (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin~     D deficient patients with non-optimally controlled type 2 diabetes mellitus.~   "
81471|NCT01991028|"~     OligoG is a new potential treatment which is being developed by AlgiPharma AS (a~     Norwegian-based company) with an aim to help people with cystic fibrosis in the future.~      OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to~     reduce mucus thickness and improve mucus clearance. It could also have the benefit of~     reducing the incidence of infections.~      Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three~     consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups~     tolerated the medication well, with no treatment related issues reported. The dose~     administered in this study is lower; patients who complete the study will receive, in total,~     186 mg of OligoG in two divided doses.~      A new dry powder formulation of OligoG has been developed so that patients can use an~     inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is~     much quicker and more practical for the patient.~      In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and~     nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is~     a well-established medical imaging technique. A small amount of radioactive material will be~     added to both the dry powder and nebulised solution. The radiation emitted will then be~     detected by taking images using a device known as a gamma camera. The procedure is~     relatively easy and non-invasive.~      The purpose of this study is to help answer the following research questions:~        -  How do the OligoG dry powder and nebulised solution distribute in the lungs of patients~          with cystic fibrosis?~        -  How much of the formulation gets to the deep lung?~        -  How much of the formulation remains in the devices used for administration?~   "
81472|NCT01991015|"~     The goal of this study is to better understand gender differences in end-of-life~     communication between physicians and patients with advanced cancer in the hospital.~   "
81473|NCT01991002|"~     The scientific literature shows a quantitative relationship between diet combined with~     physical activity as a long term weight reduction modality and an important factor in weight~     maintenance.~      Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term~     maintenance.~      Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and~     biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.~   "
81474|NCT01990989|"~     The aim of the present study is to evaluate candidate variables,including Cytochrome P450~     2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score~     that can be easily adopted by clinicians to identify patients who are at risk for HPR and~     composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet~     therapy.~   "
81475|NCT01990976|"~     The safety of guided practice of physical activity in myopathies is increasingly accepted,~     including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most~     common muscular dystrophy, the aerobic training showed its physiological and functional~     efficiency without affecting the quality of life of patients. The issue of exercise therapy~     extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use~     of a training program combining endurance exercise targeted exercises and strength is even~     more relevant.~      To complete the multidimensional assessments be managed by each team ( physiological~     assessments, functional tissue and quality of life) it is relevant to continue , for a~     descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy~     (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).~   "
81476|NCT01990963|"~     Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using~     Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data~     of brain tissue after patients with severe brain trauma~   "
81477|NCT01990950|"~     This post-market study is approved by the US FDA to evaluate the long-term safety and~     performance of the Zenith® Fenestrated AAA Endovascular Graft.~   "
81478|NCT01990937|"~     Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy~     ?~   "
81479|NCT01990924|"~     Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS)~     vs. conventional 15 FPS for reduction of operator and patient radiation dose during~     diagnostic coronary angiography and percutaneous coronary intervention via the transradial~     approach.~      Background: Transradial approach for cardiac catheterization is potentially associated with~     increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation~     exposure.~   "
81480|NCT01990911|"~     The autonomic nervous system plays an important role in the precipitation of AF in~     structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent~     new-onset AF.~      Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency~     energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that~     RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and~     improvement of diastolic dysfunction follow as a consequence of afterload reduction and~     renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial~     pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci~     originate.~      Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by~     reducing afterload. These synergistic mechanisms may prevent new-onset AF.~   "
81481|NCT01990898|"~     This is a study for patients that have a condition called Interstitial Cystitis, also known~     as Painful Bladder Syndrome. Patients would have tried at least two different therapies,~     unsuccessfully,(eg. medications, pelvic floor physical therapy)~      The purpose of this research project is to study the immunosuppressive drug Cyclosporine in~     patients with Interstitial Cystitis to assess how well it works, what the side effects are~     and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent~     organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for~     Interstitial Cystitis. Several research studies have been published showing that~     Cyclosporine can improve the symptoms of Interstitial Cystitis, that it works better than a~     placebo (sugar pill or inert treatment) and that it works more effectively than Pentosan~     Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in~     these studies on Interstitial Cystitis are much lower that the doses used to prevent~     rejection in transplant patients.~      Based on these studies, the American Urological Association has recently published treatment~     guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure~     of other more conservative therapies and medications. Nevertheless, much is not known about~     using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the~     ideal dose, how best to monitor for side effects and in particular whether kidney damage can~     occur at the low doses used in these studies. In this study, to examine the mechanism of~     action, blood and urine samples will be collected before, during and after therapy to look~     at biomarkers, chemical substances that can be associated with inflammation and tissue~     injury. We will also test effects of therapy on skin sensation and pain perception because~     the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct~     pain signals.~      This study is only being done at the Cleveland Clinic and will involve about 30 patients~     with Interstitial Cystitis.~   "
81483|NCT01990872|"~     This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial~     (RCT) aims to examine the impact of various levels of habitual calcium intake on dietary~     vitamin D requirements in older adults stratified by calcium intake. This will provide new~     data on the impact of different levels of calcium intake, ranging from low/moderate to high,~     on winter serum 25(OH)D levels, and their utilization and catabolism in adults.~   "
81484|NCT01990859|"~     The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese~     subjects with advanced melanoma~   "
81485|NCT01990846|"~     To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat~     escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects~   "
81486|NCT01990833|"~     For non-healing ulcers, abnormal periods of wound healing processes: inflammation,~     proliferation and remodelling, are believed to lead to chronic wounds. As a chronic~     stalled wound, investigators hypothesized that these glue-assisted closure (GAC)-failed~     enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by~     excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the~     chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.~   "
81487|NCT01990820|"~     Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease.~     Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back~     of the throat) is performed since the adenoid pad may trap germs that enter a child's body~     and can get so swollen with bacteria that they become infected themselves. Functional~     endoscopic sinus surgery (FESS) and adenoidectomy are currently the most common surgeries~     performed on children with this disease. Another treatment is adenoidectomy and irrigation~     of the maxillary sinus without FESS. New technology has emerged using a balloon catheter to~     dilate (open) the sinus passage in addition to the adenoidectomy and irrigation. This study~     seeks to answer if children with chronic rhinosinusitis who undergo adenoidectomy with~     balloon dilation of the maxillary sinus passage and irrigation experience improved quality~     of life outcomes compared to children with chronic rhinosinusitis who undergo an~     adenoidectomy with maxillary sinus irrigation without dilation of the sinus passage.~   "
81488|NCT01990807|"~     The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly~     in recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase~     Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in~     some high risk groups, The prognosis of patients is still very bad and the relapse rate is~     high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.~   "
81489|NCT01990794|"~     The purpose of this study is to investigate steady-state cobalt levels following dietary~     supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy~     adult volunteers.~   "
81490|NCT01990781|"~     Post operative sore throat (POST) following tracheal intubation is a common problem causing~     dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and~     dexamethasone has been used independently for this purpose. However, there is no study~     assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The~     purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine~     dexamethasone combination on the incidence and severity of POST.~   "
81491|NCT01990768|"~     Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the~     prehospital setting in patients with moderate to severe TBI (GCS score ≤12).~      Primary hypothesis: The null hypothesis is that prehospital administration either of two~     dosing regimens of TXA in patients with moderate to severe TBI will not increase the~     proportion of patients with a favorable long-term neurologic outcome compared to placebo,~     based on the GOS-E at 6 months.~      Secondary aims: To determine differences between TXA and placebo in the following outcomes~     for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing~     regimens of TXA:~        -  Clinical outcomes: ICH progression, DRS at discharge and 6 months, GOS-E at discharge,~          28-day survival, frequency of neurosurgical interventions, and ventilator-free,~          ICU-free, and hospital-free days.~        -  Safety outcomes: Development of seizures, cerebral ischemic events, myocardial~          infarction, deep venous thrombosis, and pulmonary thromboembolism.~        -  Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway~          mediators and degree of clot lysis based on TEG.~      Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital~     GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90~     mmHg, prehospital IV or intraosseous (IO) access, age ≥ 15yrs (or weight ≥ 50kg if age is~     unknown), EMS transport to a participating trauma center.~      Exclusion: GCS=3 with no reactive pupil, estimated time from injury to hospital arrival >2~     hours, unknown time of injury, clinical suspicion by EMS of seizure activity or known~     history of seizures, acute MI or stroke, CPR by EMS prior to randomization, burns > 20%~     TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA given~     prior to randomization, subjects who have activated the opt-out process when required by~     the local regulatory board.~      A multi-center double-blind randomized controlled trial with 3 treatment arms:~        -  Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram~          IV maintenance infusion initiated on hospital arrival and infused over 8 hours.~        -  Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo~          maintenance infusion initiated on hospital arrival and infused over 8 hours.~        -  Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance~          infusion initiated on hospital arrival and infused over 8 hours.~   "
81492|NCT01990755|"~     Background. Treatments of eating disorders result too often in partial psychological and~     physical remission, chronic course, dropout, relapse and death, with no fully known~     explanations for this failure. In order to clarify this problem, we conducted a three~     branches study to identify the biochemical background of cognitive-behavioral psychotherapy~     (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy~     with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma~     homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol~     (MHPG) for noradrenalin secretion, and platelet [3 Hydrogen]-Paroxetine-binding Bmax and Kd~     for serotonin transporter function. The data were then compared with psychopathological and~     physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on~     plasma HVA, MHPG and [3 Hydrogen]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging,~     and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in~     15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine~     (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated~     measures for the changes between basal and post-treatment biological and psychological~     parameters, two-way ANOVA for repeated measures for the differences in the psychobiological~     data in the 3 groups, Spearman's test for the correlations between basal and final changes~     in the psychological and biological scores.~   "
81493|NCT01990742|"~     One in three Americans dies in a nursing home (NH) or in a hospital, shortly following~     transfer from a long-term care facility. The proportion of deaths occurring in NHs is~     projected to increase to 40% by 2020. Excellence in palliative and end-of-life (EOL) care~     must become a priority for these long-term care institutions. However, findings from NHs~     point to high incidence of pain and poor management of other symptoms and excessive reliance~     on hospitalizations, indicating inadequate EOL care quality. Expert opinion and research~     have suggested that poor EOL quality in NHs may be due to lack of palliative care training~     among staff and absence of EOL care protocols or guidelines, but research demonstrating that~     attention to these factors improves outcomes is absent. While dedicated care teams have been~     shown to improve outcomes for NH residents in need of specialized care, the impact of~     palliative care teams in improving resident outcomes has remained largely unstudied and~     untested. This will be the first randomized controlled trial to evaluate the impact of~     palliative care teams (PCTeam) on resident and staff outcomes, and care processes, in NHs.~      Our objective is to demonstrate, using a randomized controlled trial design and a difference~     in difference analytic approach, that nursing home-based palliative care practice guidelines~     implemented through PCTeams will improve quality of care processes and outcomes for~     residents at the end of life.~      We will adapt existing palliative care guidelines for EOL care, endorsed by the National~     Quality Forum (NQF), to the NH environment, deploy the adapted practice guidelines through a~     PCTeam model, and evaluate the effectiveness of this intervention on resident EOL outcomes~     and staff care processes and outcomes. The specific aims (SA) will address the following~     questions:~      SA 1: Is PCTeam intervention effective in improving NH residents' EOL outcomes?~      SA 2: Is PCTeam intervention effective in improving NH staff EOL care processes and~     outcomes?~      In the context of these specific aims we will test the following hypotheses:~      H1: Residents in NHs in the intervention arm, compared to the control, will achieve better~     EOL risk-adjusted outcomes and care processes with regard to:~        -  Pain~        -  Dyspnea~        -  Depression~        -  In-hospital deaths~        -  Hospitalizations~        -  Advance directives~      H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve~     better EOL processes and outcomes measured by:~        -  Assessment of EOL symptoms~        -  Delivery of EOL care~        -  Communication/coordination among providers~        -  Communication with residents/families~        -  Teamwork effectiveness~        -  Staff satisfaction~      H3: Family caregivers of decedent residents in the intervention NHs, compared to the~     control, will report receiving more patient and family centered care as measured by higher~     levels of satisfaction with:~        -  Shared decision making between providers, the patient and the family~        -  Care that is respectful of the patient wishes and dignity~        -  Attention to the emotional and spiritual needs of the family.~           31 NHs in upstate New York have been recruited for the study (letters of support).~          Stakeholders include residents, family members, staff, policy makers, and others. The~          intervention will deploy theTeamSTEPPS, a team development model created by the~          Department of Defense and the Agency for Healthcare Research and Quality.~   "
81494|NCT01990729|"~     To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment~     of non-specific low-back pain of lumbosacral localization in ambulatory care.~   "
97055|NCT01786642|"~     The aim of the present study is to measure the time to correction of O2 saturation when in~     case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal~     route at a similar flow rate.~   "
81495|NCT01990716|"~     We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6-~     EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We~     will evaluate its possible use as a pathological activity biomarker and its potential as a~     therapeutic target.~      We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities~     depending on the pathological state of the IBD patient.~   "
81496|NCT01990703|"~     We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after~     birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their~     birth, wish to breastfeed, and are willing to participate in the study will be randomly~     assigned to either get the IUD placed immediately after delivery of the baby and placenta or~     4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after~     delivery between those who get the IUD placed early or later.~   "
81497|NCT01990690|"~     To predict the effect of antioxidants in cases of oligohydramnios~   "
81498|NCT01990677|"~     To test the effect oral eplerenone versus placebo in patients with central serious~     chorioretinopathy .~   "
81499|NCT01990664|"~     This study is an open-label, multi-site study. The total number of subjects was 200. The~     duration of this study was approximately four weeks. The primary objective was to assess~     what percentage of lapsed contact wearers, who have discontinued use of their contact lenses~     for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly~     replacement daily wear lenses (spherical and toric designs).~   "
81500|NCT01990651|"~     The purpose of this study is to assess whether the detection of circulating tumor cells~     (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment~     response / failure and predict overall survival in non-small cell lung cancer (NSCLC)~     patients~   "
81501|NCT01990638|"~     The purpose of this study was (1) to compare the peak exercise capacity and left ventricular~     diastolic function between patients with and without diabetes and (2) to investigate the~     interrelation among peak oxygen consumption, left ventricular diastolic function, blood~     sugar, and lipid profile.~   "
81502|NCT01990625|"~     In many low-income countries, the use of ultrasound by medical officers and non-physician~     health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is~     a new intervention requiring authoritative investigation. The primary hypothesis to be~     assessed in this study is that antenatal ultrasound screenings performed by medical officers~     and non-physician health care staff will significantly reduce a composite outcome consisting~     of maternal mortality and maternal near miss, stillbirth and neonatal mortality in~     low-resource settings. Underpinning this hypothesis are two assumptions. The first~     assumption is that antenatal detection of complicated pregnancies will lead to appropriate~     referral at the right time for complicated pregnancies to comprehensive emergency obstetric~     and neonatal care (EmONC) facilities. The second assumption is that ultrasound's~     introduction will increase antenatal attendance leading to greater rates of institutional~     delivery. To assess these underlying assumptions beyond the composite end point, this study~     will investigate the health system impact of compact ultrasound. Secondary outcomes include~     antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral~     rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent)~     and an assessment of medical officers and non-physician health care provider ultrasound~     competence and training quality.~   "
81503|NCT01990612|"~     Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of~     labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal~     morbidity and perinatal mortality.~   "
81504|NCT01990599|"~     Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is~     very delicate. This is because of the specific operation site and moreover patients should~     recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon.~     Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An~     obvious alternative airway management, as performed in this preliminary study, is a~     nasopharyngeal placed tube.~      The purpose of the present study is to objectify the gas exchange in patients during this~     new ventilation technique.~   "
81505|NCT01990586|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release~     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout~     period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81506|NCT01990573|"~     Three arm randomized controlled trial to evaluate the efficacy of a single dose of~     intraoperative methadone in reducing post-operative pain and opioid consumption in~     adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the~     pharmacokinetics of IV methadone in children (0.4 and 0.5 mg/kg).~   "
81507|NCT01990560|"~     The purpose of this study is to determine whether mifepristone is an effective treatment for~     hyperglycemia due to mild hypercortisolism.~        -  To test the hypothesis that GR blockade with mifepristone will decrease the severity of~          metabolic syndrome features as measured by waist circumference, lipid profile, body~          mass index, blood pressure and insulin resistance, measured by HOMA-IR score.~        -  To test the hypothesis that GR blockade with mifepristone will improve QoL, depression~          and anxiety scores, measured by validated assessments, in patients with mild~          hypercortisolism.~   "
81534|NCT01990209|"~     The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75~     percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may~     be a target in patients with advanced breast cancer. Breast cancer patients whose tumors do~     not express the ER, PR or HER2 (triple negative) have very few options for treatment.~     Orteronel is being developed as an endocrine therapy for relevant hormone-sensitive cancers~     such as prostrate cancer and breast cancer. Triple-negative metastatic breast cancer~     patients with AR expression could potentially benefit from anti-androgen therapy like~     orteronel.~   "
81535|NCT01990196|"~     Prostate cancer is the most common cancer in men and the second leading cause of cancer~     death in men. The purpose of this research study is to compare prostate cancers treated with~     hormone therapy versus prostate cancers treated with hormone therapy plus drugs that~     directly target cancer cells.~   "
81508|NCT01990547|"~     The main purpose of this study is to determine whether functional magnetic resonance imaging~     (fMRI), can distinguish between service members with and without traumatic brain injury~     (TBI), as well as those with posttraumatic stress disorder (PTSD) who receive either virtual~     reality exposure therapy (VRET) or PTSD treatment other than exposure therapy. The~     investigators and other investigators have previously identified changes in function in~     multiple regions of the brain in combat veterans with PTSD, and the investigators have also~     seen that structural changes in the white matter associated with combat TBI are also linked~     with changes in function, and in turn with PTSD symptoms. However, the investigators need to~     confirm these findings in larger numbers, and also need to discern whether fMRI can~     distinguish if there is something significantly different about those who have PTSD after~     TBI vs. those in whom it does not follow a TBI. Finally, the investigators have previously~     demonstrated that exposure therapy ameliorates the functional changes in the brain induced~     by PTSD, but the investigators do not know if similar changes occur with other forms of~     therapy, so the investigators seek to compare the two directly. It is our expectation that~     the findings will better inform the choice of therapy for service members with~     combat-related PTSD, with or without TBI.~   "
81509|NCT01990534|"~     This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy~     and safety of brentuximab vedotin as a single agent in adult patients with histologically~     confirmed CD30+ relapsed or refractory classical HL who have not received a prior stem cell~     transplantation (SCT) and are considered to be not suitable for SCT or multiagent~     chemotherapy at the time of study entry.~   "
81510|NCT01990521|"~     Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive~     prostate cancer compared to men in the general population.~      Standard of care screening for men with a BRCA mutation includes PSA testing and digital~     rectal examination (DRE), the same as with men in the general population.~      This study is being done to assess whether there is value in using MRI as a screening tool~     to detect prostate cancer at an earlier stage than may otherwise be detected using standard~     of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in~     this specific population at high risk for aggressive disease.~   "
81511|NCT01990508|"~     Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance~     Program (SNAP), and 50% are children. Although the goal is to improve nutritional health,~     preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic~     risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs).~     This pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by~     low-income families with children by combining targeted point-of-purchase education with a~     randomized trial of financial incentives to discourage purchase of unhealthy beverages. The~     study will take place at a mid-size grocery store that is located in a low-income, Latino~     community and where 30% of purchases are made with SNAP. Targeted beverage education will be~     provided to all study subjects with a traffic-light system to identify healthy and unhealthy~     beverages at the point-of-purchase. Individual beverage purchases will be tracked by~     electronically stored cash register sales. Supplementary validation of beverage consumption~     will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled~     trial to compare purchase and consumption of SSBs by families assigned to a financial~     incentive to reduce purchase of SSBs with families assigned to control (no incentives). Aim~     2 is to compare the purchase of SSBs by families in both arms during the study period when~     they are exposed to the traffic-light system to a baseline period prior to traffic-light~     education. Results of this project will provide pilot data for larger scale interventions to~     promote healthy choices among low-income families.~   "
81512|NCT01990495|"~     The majority of individuals with advanced ESRD have reduced exercise capacity in part due to~     decreased muscle mass. This leads to a reduced ability to perform daily activities, a~     greater incidence of falls, and a reduced quality of life. The mechanisms responsible for~     the loss of muscle mass in ESRD are not understood very well. This study is designed to~     determine the effectiveness of an exercise program on improving muscle mass, exercise~     capacity and quality of life in persons with ESRD. In addition, the study will attempt to~     better understand why muscle loss occurs in people with ESRD, the influence exercise has on~     these mechanisms, and whether the response to exercise can be enhanced with nutrient~     supplementation.~   "
81513|NCT01990482|"~     A delay in the return of normal bowel function with the passage of flatus and feces is one~     of the most important factors affecting early recovery and discharge in patients undergoing~     open complete staging surgery for gynecological malignancies. A prolonged hospital stay~     increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary~     compromise and total hospital costs.~      The aim of this study was to assess the effectiveness of coffee intake on postoperative~     bowel function in patients undergoing abdominal complete staging surgery for gynecological~     malignancies.~   "
81514|NCT01990469|"~     After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in~     a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing~     stable doses of glimepiride in combination with metformin for 24 weeks.~   "
81515|NCT01990456|"~     Due to lack of studies on mechanical ventilation strategies in patients with severe Acute~     Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane~     Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.~      In this two-phases prospective, interventional, pilot study we hope to gain physiologically~     relevant data on two aspects of mechanical ventilation in patients with severe ARDS~     supported with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive~     End-Expiratory Pressure (PEEP).~        1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP~          strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared~          to the current mechanical ventilation practice that employs tidal ventilation in~          patients with severe ARDS on ECMO.~           In this first phase we will test whether administering a distending inspiratory~          pressure to produce tidal ventilation is superior to a strategy where only continuous~          positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI)~          mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic~          measurements.~        2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP~          to maximize respiratory system compliance reduces VILI in patients with severe ARDS on~          ECMO.~      In the second phase we will therefore gain more insight as to whether a strategy that~     utilizes a PEEP level that correspond to best compliance is beneficial over Zero~     End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma~     (serum cytokines), physiologic parameters, and right ventricular function (transesophageal~     echocardiographic assessment).~      Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of~     imaging techniques that require transport, such as computed tomography, is limited.~     Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and~     focused bedside cardiac ultrasonography, are important tools for clinicians who care for~     these patients. This study will allow us to learn whether these techniques are feasible and~     valid in this patient population.~      Furthermore, the knowledge gained from this study will allow us to assess the rationale and~     feasibility of performing a similar larger, randomized study in the future.~   "
81517|NCT01990430|"~     Exercise training has been established as a feasible and safe intervention during or after~     neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise~     can prevent and control various treatment-related side effects including functional~     limitation, physical capacity, anxiety and sleep disturbance. In the long-term, an active~     life style has been demonstrated to increase survival in women, who maintain a moderate~     level of exercise per week (30 or 75 minutes of brisk walking 5 days per week).~      Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality~     and 33-82% lower all cause of mortality. But despite this, most breast cancer patients~     reduce their physical activity levels during and after cancer treatment. In 2010, a~     roundtable meeting of American College of Sport Medicine published guidelines for cancer~     survivors, defining that the recommended amount of exercise was 150 minutes per week of~     aerobic exercise of moderate-intensity and 2 or 3 days per week of strength training that~     included exercise for major muscle groups. But only 30-47% of breast cancer survivors follow~     these exercise recommendations.~      In most clinical settings, information by the oncologist to keep physical active is part of~     the recommendation. Yet some breast cancer patients find it difficult to begin or maintain~     the minimal activity levels recommended by the experts. A typical obstacle includes lack of~     directions from experts, which can assure the safety and feasibility of the exercise that~     they perform. Moreover, important personal aspects can have major influence on the exercise~     preference, including certain food choice and dietary intakes, education level or the~     preference of a face-to-face exercise counseling by a professional.~      A cancer diagnosis is recognized as teachable moment, where patients are particularly~     motivated for lifestyle changes. So it is important to approach the patients with adequate~     interventions that consider the different needs in order to get a healthier behavior among~     the breast cancer patients.~      Taking this into account, the hypothesis of this pilot project is that a guided integrated~     group exercise program, which includes an educational program on healthy life style, will~     increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore~     the aim of this pilot study was to investigate if a comprehensive and specific group~     exercise program, which includes dietary and exercise information, could increase~     leisure-time exercise in women with breast cancer.~   "
81518|NCT01990417|"~     The present study aimed to analyze the influence of passive stretching before and after~     strength training on flexibility of the hamstrings in people who work out~   "
81519|NCT01990404|"~     Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide~     and oxygen is used in the emergency medical care of the trauma, burns, during transport of~     patient with pain. None randomized study has validated the use of premixed nitrous oxide and~     oxygen in the emergency department in the elderly. The aim of the study is to demonstrate~     the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient~     with out-of-hospital severe acute pain~   "
81520|NCT01990391|"~     The purpose this research is to check the effect of Brazil Nuts consumption in oxidative~     stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and~     hypertensive patients.~   "
81521|NCT01990378|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release~     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout~     period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
81522|NCT01990365|"~     Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of~     low back pain. But there are only part of patients with acute OVFs, because some patients do~     not have low back pain although OVFs occurred.~   "
81523|NCT01990352|"~     Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on~     response when metastatic breast cancer patients are treated with DNA damaging chemotherapy~     agent, compared to historical controls~      Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect~     on tumor progression when metastatic breast cancer patients are treated with DNA damaging~     chemotherapy agent, compared to historical controls~   "
81524|NCT01990339|"~     To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective~     symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms~   "
81525|NCT01990326|"~     This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on~     excess submental fat, also known as double chin. The study will also assess the safety and~     tolerability of XAF5 Gel.~   "
81526|NCT01990313|"~     The purpose of this study is to provide objective measurements of abnormal movements of the~     body in correlation with neural activity of the brain and track how these change over time.~     This may allow for the development of objective evaluation of the neural activity causing~     abnormal movements, which may lead to the ability of the DBS system to stimulate the brain~     by sensing the abnormal neural activity that is causing abnormal movements.~   "
81527|NCT01990300|"~     The purpose of this study is to examine the safety and efficacy of long-term use of~     alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes~     mellitus determined as warranting combination therapy with alogliptin benzoate and~     pioglitazone hydrochloride~   "
81528|NCT01990287|"~     The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation~     with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.~   "
81529|NCT01990274|"~     The purpose of this study is to compare two different methods of intensified tuberculosis~     (TB) case finding in the community. These methods all involve the use of a mobile clinic to~     reach people with TB symptoms who are not able to readily access clinic services. A standard~     diagnostics package consisting of smear microscopy and culture (with smear result available~     the next day) will be compared with a novel diagnostics package involving point-of-care~     sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day~     result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV~     +ve subjects only). The primary outcome is a comparison between the number of culture +ve~     subjects on TB treatment in each group at the end of two months. A secondary aim is an~     evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic.~     Additional study aims include using chest X-rays obtained during the study to develop and~     validate of an computer-aided diagnosis (CAD) software package for TB (together with~     collaborators in the Netherlands), as well as establishing whether LAM is detectable at~     sub-ELISA concentrations in the urine of those with TB.~   "
81530|NCT01990261|"~     This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR)~     participants treated with Tarceva after at least one failed chemotherapy treatment, and the~     impact of prior chemotherapy treatments.~   "
81531|NCT01990248|"~     This multi-center, prospective, observational safety study will evaluate the safety and~     effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated~     patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be~     collected for 2 years.~   "
97056|NCT01786629|"~     To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved~     control as bowel preparations prior to colonoscopy in adult patients.~   "
81536|NCT01990183|"~     Stroke and other neurological conditions affect the population of infants in percentages~     that cannot be considered marginal. Preterm infants are the highest infants at risk for~     neurological damage. Currently, infants have rehabilitation sessions few times a week in~     rehabilitation centres but according to basic neuroscience it would be necessary to provide~     them with an early, intensive and multiaxial intervention. One option to reduce the cost of~     the entire European Healthcare System while increasing the practice of rehabilitation is to~     devise therapies and technologies that can be administered at home by caregivers and~     telemonitored by rehabilitation staff. The aim of this proposal is to promote early~     intervention in the first year of life and to reinforce therapy by CareToy: a portable low~     cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy~     while reducing the cost. The smart system is based on a common baby gym, composed of~     different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the~     infants' actions on the gym can be measured and stimulated, b) a vision module, for~     measuring and promoting infants' attention and gaze movements and c) a sensorized mat for~     measuring and promoting postural control. Each module will also incorporate built-in signal~     processor, memory and wireless communication. A fourth telerehabilitation module completes~     the system that allows the system to remotely communicate with the rehabilitation staff for~     monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of~     home rehabilitation based on this system will be validated by clinical trials on at least 50~     preterm infants. The result of this project could have a large impact. CareToy may become a~     commercial product, manufactured on a large scale and distributed not only in rehabilitation~     centres but also at homes, sold or rented by the Health Care System to families as a~     therapeutic tool for care intensity.~   "
81537|NCT01990170|"~     The purpose of this study is to determine long term healing rates of chronic venous ulcers~     (CVU) after ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR)~     and to relate recurrence of CVU to evidence of recanalisation and the presence of~     superficial or deep venous reflux~   "
81538|NCT01990157|"~     This study is in two stages:~      Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in~     patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not~     enough effective.~      Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected~     TAB08 dose in extended patient population with active Rheumatoid Arthritis in which~     methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.~   "
81539|NCT01990144|"~     The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine~     (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined~     as frail according to CGA.~   "
81540|NCT01990131|"~     The purpose of this study is to test the effectiveness and usability of multiple~     computer-based treatments for mood and anxiety relevant risk factors. The target of the~     treatment is related to cognitive stress, which has been shown to be associated with a~     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal~     ideation, and substance use disorders.~   "
81541|NCT01990118|"~     The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the~     standard treatment Neoral® for a treatment period of 6 months in stable renal allograft~     transplant recipients with respect to drug levels, dosage, and acute graft rejection and~     other adverse events.~   "
81542|NCT01990105|"~     FINFIB 2 is an observational investigator-driven study that seeks to examine current~     treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that~     the treatment of atrial fibrillation has improved since the introduction of new~     antiarrhythmic drugs and anticoagulants.~   "
81543|NCT01990092|"~     The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and~     nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic~     peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks~     of treatment, and long-term effects will be evaluated over the duration of a 48 week~     treatment period.~   "
81544|NCT01990079|"~     The primary goal of the study is to evaluate the use of a new smart phone application in~     preventing relapse to smoking among people with PTSD. The technology intervention will~     combine a mobile system to reward non-smoking, smoking cessation counseling, smoking~     cessation medications, and use of the smart phone app. The primary aim is to evaluate how~     effective this intervention is in preventing smoking relapse compared to another~     intervention that does not include the app.~   "
81545|NCT01990066|"~     Implementation of a home based exercise program to reduce functional decline, cancer related~     fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient~      Problem:~      Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology~     patient undergoing chemotherapy?~      Support:~      Fatigue and its impact on QOL is a major concern with the elderly patient receiving~     chemotherapy. When compared to younger adults QOL is more important than gain in survival~     for elderly patients. (Eyigor, et al., 2010).~      The National Comprehensive Cancer Network recommends exercise as the most effective~     intervention for cancer related fatigue.~      Methods:~      This is a single institution randomized controlled study to evaluate a home based exercise~     program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be~     randomized to the intervention group or to the control group receiving usual care.~      Intervention group will receive a home exercise program 3 days weekly consisting of 30mins~     of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to~     assist with compliance.~      The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6~     minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the~     NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional~     Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint),~     and following cycle 6 (completion).~      Conclusion:~      PT directed home exercise program may improve CRF, functional decline, and QOL in elderly~     gynecologic oncology patients undergoing chemotherapy.~   "
81546|NCT01990053|"~     Standard treatments for depression in specialty care settings are effective but resources~     for delivering empirically supported psychotherapies are often limited. Computerized~     cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for~     depression that might help expand services in psychiatric settings, however, little is known~     about its efficacy in this population. The present study aims to establish the efficacy of a~     internet-delivered cCBT program (Beating the Blues) plus email and telephone support for~     depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an~     assessment procedure designed to identify moderators of treatment effectiveness.~   "
81547|NCT01990040|"~     This is a global prospective, observational, multi-center registry to evaluate the long-term~     safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide~     in a routine clinical setting. The registry will also evaluate the long-term clinical~     outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be~     enrolled.~   "
81549|NCT01990014|"~     The objective of this protocol is to evaluate the quality of life and functional disability~     in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien~     stroke who received a decompressive craniotomy in the acute phase. Patients who have given~     their consent to be evaluated at least two years after their stroke and their operation in a~     single visit by clinical examination and procurement of standardized scales. Will be~     measured the quality of life through scale SIS3.0, residual disability by the Rankin scale.~     The quality of life of the carer will be assessed through scales and Zarit carer version of~     SIS3.0. The existence of predictive parameters of long-term evolution will be searched in~     determining the existence of a correlation between demographic data and baseline~     characteristics of the stroke on and the evolution of the quality of life.~   "
81550|NCT01990001|"~     The broad objective of this research is to determine whether a quick, simple intervention~     will increase utilization of contraceptive reminders and adherence to short‐term~     contraceptive regimens. Such an intervention could be implemented easily with no additional~     resources into a busy clinical practice.~   "
81551|NCT01989988|"~     The investigators would like to conduct a randomized clinical trial to compare the efficacy~     of diabetes treatment between different gastric bypass procedures involving type 2 diabetics~     patients with BMI from 27.5 to 35 kg/m2~   "
81552|NCT01989975|"~     The purpose of this study is to evaluate the performance, patient satisfaction and safety of~     connectivity gateway device CareLink Connect, transferring CGM data from a VEO insulin pump~     to CareLink online (every 5th minute) and thereby making it available for patients or Care~     Partners individual web connected devices such as smartphones, tablets and PCs.~   "
81553|NCT01989962|"~     Education for Equity (E4E)intervention intends to improve care delivery through a well~     designed educational program that address not only the issues of diabetes care delivery to~     Aboriginal patients with diabetes, but also the issues of effective cross-cultural and~     culturally safe communication between healthcare providers and Aboriginal patients, and the~     issues related to effective implementation of appropriate chronic disease management~     programs for Aboriginal patients in a range of practice settings. The purpose of this study~     is to evaluate the effectiveness of the E4E education program through measuring patient~     clinical outcomes, patient experience with their doctors, and the changes in physicians'~     approaches to care perceived by Aboriginal diabetic patients.~   "
81554|NCT01989949|"~     This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult~     subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving~     seven (7) doses of 1.0 mg/kg IV TP-434.~   "
81555|NCT01989936|"~     To determine the tolerability and efficacy of eletriptan in patients who had discontinued~     oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous~     clinical treatment (not a controlled trial).~   "
81556|NCT01989923|"~     This feasibility study will compare two smoking cessation methods, traditional nicotine~     replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in~     patients with gynecological conditions.~   "
81557|NCT01989910|"~     A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based~     combination therapy in treatment-naïve patients with HIV-1 infection.~   "
81558|NCT01989897|"~     This is a double-blind study with respect to the diluents used, with patients known to be~     allergic to the specific allergen tested. Three study sites will be involved, each testing~     one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the~     allergen in question will be tested with serial three-fold dilutions to determine the ID 50~     and relative extract potency using the method described by Turkeltaub.~   "
81559|NCT01989884|"~     Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma~   "
81560|NCT01989871|"~     The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting~     from transition to oral feeding (33 weeks corrected age) will result in less episodes of~     apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten~     hospitalization duration in the short term.~      In the long term AIF will result in higher scores on the Griffith's developmental scales,~     decreasing parental anxiety and feeding disorders .~   "
81561|NCT01989858|"~     The study addresses two primary questions, according to its factorial design:~        -  to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a~          post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a~          post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study);~        -  to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical~          CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX~          Study).~      The study has a 2x2 factorial design, thus consisting of two independent, following specific~     eligibility criteria and with different randomization scheme studies, the Timing Study and~     the RTX Study.~      Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials~     conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which~     is considered operable.~      In the Timing Study patients fulfilling the eligibility criteria will be randomized with a~     1:1 ratio to receive:~        -  peri-operative CHT (Arm A) or~        -  post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be~          randomized in the RTX~      Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other~     treatment. This is possible since the randomization will be done in two steps: the first for~     the Timing Study for all the participating centres (peri-operative CHT vs. post-operative~     CHT) and the second one for the RTX Study, only for those centres with the radiotherapist~     willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the~     following four arms will be generated:~        -  peri-operative CHT (Arm A)~        -  post-operative CHT (Arm B)~        -  peri-operative CHT + post-operative CHT-RTX (Arm C)~        -  post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more~          than one hundred experimental centres. Follow-up F(-up) procedures and timing of the~          visits will be consistent with current clinical practice.~      Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in~     the RTX study.~   "
81568|NCT01989767|"~     The hypothesis was that education of rehabilitation officers who were responsible for~     rehabilitation back to work for sick-listed individuals in screening for mental disorders~     and psychiatric topics would increase the rate of return to work and reduce the number of~     sicklisted days~   "
81569|NCT01989754|"~     The purpose of this study is to assess the effect of canagliflozin compared to placebo on~     progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard~     care but with inadequate glycemic control and at elevated risk of cardiovascular events.~   "
81570|NCT01989741|"~     -  hypothesis: sleep restriction in healthy subject trigger alteration of decision making~          associated with immuno-inflammatory changes~        -  inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles,~          intermediate chronotype~        -  design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep~          restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).~        -  parameters: decision making tests, reaction time, wakefulness test, biological~          parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure~        -  control of sleep restriction: continuous polysomnographic survey~   "
81562|NCT01989845|"~     Rivaroxaban has been developed in the various clinical settings, prevention of venous~     thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial~     fibrillation, and in the treatment of acute coronary syndromes. And, in the~     EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs,~     rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT.~     However, there has been limited experience of rivaroxaban with secondary VTE prophylaxis in~     cancer patients. Although cancer-associated DVT or PE was included in previously mentioned~     EINSTEIN programs, only approximately 5% of the total populations were cancer patients in~     these studies. Thus, investigators could not automatically translate the results of these~     studies into the real practice management of cancer-associated VTE patients. Moreover, until~     now, new oral anticoagulants, including dabigatran and rivaroxaban, have been compared to~     long-term warfarin therapy, which were well-known inferior agent, but not low molecular~     weight heparin. In this sense, investigators feel that new oral anticoagulants, particularly~     rivaroxaban, should be re-investigated in this highly specific patients group. Therefore,~     investigators are planning to conduct a prospective study evaluating the efficacy and safety~     of rivaroxaban in Korean patients with cancer-associated VTE.~   "
81563|NCT01989832|"~     The prevalence of renal acute rejection in transplantation is reduced thanks to the~     optimized use of immunosuppressive drugs. However, graft survival at ten years has not~     improved since then; this may be explained in part by the toxicity of these drugs, viral~     infections, and other comorbidities (diabetes, cardiovascular diseases …).~      According to transplant center, strategies for the combination of immunosuppressive drugs~     are different, and probably involve a difference in the global cost of patient management.~     There is no recommendation in France to establish similar practices.~      EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the~     renal transplant patients.~   "
81564|NCT01989819|"~     Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often~     involving the central and peripheral nervous systems. Fifteen to twenty percent of patients~     with the primary Sjögren's syndrome have neurological complications involving the peripheral~     nervous system. Although some patients have large fiber neuropathy, around forty percent of~     patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic~     studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms,~     some have been shown to have small fiber neuropathy (SFN). A recent study proved that more~     than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.~      The aim of this study will be to investigate the occurrence of small fiber neuropathy in~     patients with pSS and neuropathic pain with normal electromyographic studies and to~     determine the existence of a conjoint local inflammatory process mediated by cellular,~     cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after~     skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been~     widely validated. A skin biopsy will be performed in patients and control and will allow~     quantification of small fiber density in skin sample along with measurement of sweat gland~     innervation. Moreover, pathophysiological studies will be carried on in order to evaluate~     the causal relationship between cellular and humoral inflammation and small fiberneuropathy.~      Recent studies have pointed out the inconstant efficacy of both corticosteroid and~     immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small~     fiber neuropathy in these patients may help designing new therapeutic strategies.~   "
81565|NCT01989806|"~     Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility~     and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life~     and shorter life expectancy. Different modalities were developed aiming at mobility~     restoration in SCI patients and robotic assisted body weight supported treadmill training is~     one of the latest technique in recent years. Yet there are scarce studies to investigate its~     effectiveness. The purpose of this study is to investigate the effectiveness of~     robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary~     function of patients suffering from SCI by a randomized controlled trial.~      80 patients suffering from incomplete SCI will be recruited for an 8-week training program.~     They will be randomized into either robotic assisted body weight supported treadmill~     training group or passive lower limb mobilization training group. The training effects will~     be measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score,~     lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis~     under sub maximal exercise stress test.~      Through the study, we intent to find the effectiveness of robotic-assisted body weight~     support treadmill training on walking and cardiopulmonary recovery with patients suffering~     from incomplete spinal cord injury.~      The hypothesis of the study is:~      Compared to the control group, robotic-assisted body weight supported treadmill training~     leads to a greater improvement in walking ability and cardiopulmonary functioning.~   "
81566|NCT01989793|"~     This research study is being done to see whether losartan can prevent the decrease in~     strength associated with aging.~      Muscle loss is associated with aging and has multiple symptoms such as weakness, slowness,~     and fatigue (tiredness). Older adults with muscle weakness have a higher risk of falls and~     disability. In addition, the loss of independence for older adults can lead to a poorer~     quality of life.~      Recently, it was discovered that losartan, a medication commonly used to treat high blood~     pressure, had slowed the strength decline seen in older mice. In addition, it allowed~     injured mice skeletal muscle to heal faster. Therefore, we would like to see if losartan can~     do the same for older adults.~      Losartan is approved by the Food and Drug Administration (FDA) for the treatment of high~     blood pressure, heart failure, and to protect the kidneys in diabetic patients. Losartan is~     not FDA-approved to prevent the decrease in strength associated with aging.~      In this study, participants age 70 and older will be asked to take losartan or a placebo to~     see if losartan can help prevent loss of muscle strength. A placebo is a substance that~     looks like the study drug but that contains no active ingredients.~   "
81567|NCT01989780|"~     To evaluate optimal usage of bevacizumab to compare which is better, continuing bevacizumab~     and paclitaxel or switching to hormonal maintenance therapy followed by~     bevacizumab+paclitaxel after induction therapy of bevacizumab+paclitaxel.~      To examine biomarkers such as monitoring markers of study treatment as exploratory analysis.~   "
81595|NCT01989416|"~     The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing~     of colonization of multi-drug resistant bacteria in intensive care unit patients.~   "
81571|NCT01989728|"~     The hypothesis was that a large fraction of individuals with common mental disorders were~     undetected in long-term sickness and that detection of the disorders by screening, a~     psychiatric diagnostic examination and feedback to the individuals, primary care, and~     rehabilitation officers improved return to work, improved quality of life and reduced~     psychological distress.~   "
81572|NCT01989715|"~     Postural balance on both feet, characteristic of the human species, is possible by the~     tension of muscle of the whole body from toes to head.~      Body position depends on many inputs such as vision, vestibule, skin receptors, states of~     muscle tension receptors. Information is integrated in a complex nervous system via the~     ascending and descending pathways. The information is then analyzed to provide feedback on~     body position. Any variation of body position, induces a variation of the center of~     pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term~     deformation (including scoliosis or kyphosis).~      Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle~     chain that controls posture. Incorrect positioning of the jaw in the three directions of~     space seems to create an asymmetric masticatory muscles activity and thus destabilize the~     muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery~     could alter the body posture via changing the activity of the masticatory muscles.~      However, nowadays no clear link has been demonstrated between maxillas repositioning and~     body posture modification.~      The purpose of this study is to highlight the link between posture and jaws position, by~     analyzing the variation of the masticatory muscles activity and, the changes in body center~     of pressure before and after orthognathic surgery of jaws standardization.~      In this study each patient will be evaluated in terms of occlusion and body posture before~     surgery and after surgery (2 months) by the same protocol. The surgery will be performed in~     the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry~     department - Prof. Salvadori La Timone Hospital, Marseille.~      The assessment includes the body posture study with a stabilometric platform (eyes open /~     eyes closed and with / without tooth contact), and analysis of the head orientation relative~     to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact )~     are devoted to check the evolution of the developed forces, and hand strength will be~     recorded using a dynamometer.~      All these data will be recorded for all the patients. Patients will be divided into four~     subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular~     retrognathia and (4 mandible repositioning.~      Statistical analysis is aimed at validating or not the hypothesis of changes in body posture~     caused by surgical maxillas repositioning.~   "
81573|NCT01989702|"~     The aim of the present study was to examine the efficacy of a probiotic-based product on~     either reducing hypertension or preventing a high normal blood pressure from reaching~     hypertensive levels.~   "
81574|NCT01989689|"~     The investigators plan to measure the health of the vascular system of subjects taking~     Etanercept for the treatment of plaque psoriasis.~   "
81575|NCT01989676|"~     The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of~     PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European~     Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic~     breast cancer in the first-line treatment setting. The hypothesis to be tested in this study~     is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.~   "
81576|NCT01989663|"~     This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial~     assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will~     be randomized to gel or film, tenofovir or placebo. This study will provide additional~     information in the evaluation of vaginal films containing microbial agents in humans. In~     addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy~     challenge model will be compared.~      This study is the first study assessing the safety of tenofovir film in humans. Tenofovir~     film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl~     cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose~     (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical~     settings.~      While the tenofovir film has not been studied extensively in preclinical studies, there are~     favorable safety data from the macaque study and a substantial body of research with~     tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical~     trial for the following reasons:~        -  No safety concerns were note in the tenofovir film macaque trial.~        -  The toxicity of tenofovir administered vaginally has been studied extensively. No~          clinically significant toxicity associated with this route of administration has been~          observed to date.~        -  All of the active ingredients of the tenofovir film have been tested in pre-clinical~          toxicity studies; therefore, the influence of these ingredients on the toxicity profile~          of tenofovir has been adequately evaluated and has been shown to result in no local or~          systemic effects.~        -  The individual components of the tenofovir film have been adequately evaluated and have~          been shown to be safe.~   "
81577|NCT01989650|"~     Recent research has suggested that endoscopist fatigue may significantly affect the polyp~     detection rate. There have been no studies on interventions that may reduce endoscopist~     fatigue and therefore improve colonoscopy performance.~      We want to determine whether a break in the middle of colonoscopy session would maintain a~     more stable adenoma detection rate~   "
81578|NCT01989637|"~     It is important to identify and evaluate foods, such as strawberries, that can improve~     established and emerging cardiovascular risk factors, such as postprandial lipid and~     glycemic responses, and vascular health. Postprandial derangements may affect multiple~     metabolic pathways that lead to increased arterial stiffness. Research has demonstrated the~     potential of strawberries to ameliorate postprandial responses to a high fat/high glucose~     meal. Further research is needed to demonstrate this effect in better controlled clinical~     studies and explore whether metabolic effects lead to improved arterial health.~      The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry~     powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including~     lipids, insulin, glucose, and arterial stiffness and central blood pressure. The~     investigators hypothesize that the bioactive components of strawberry powder will attenuate~     postprandial lipemic and glycemic responses, as well as improve measures of arterial health.~   "
81579|NCT01989624|"~     Few data are currently available in the literature on pancreatic adenocarcinoma in France.~     About 8,000 new cases each year in France. The 5-year survival for all stages combined is~     <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.~      Epidemiological characteristics at diagnosis, the impact on the survival of recent advances~     related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy~     (FOLFIRINOX) are mispriced in real life.~      The development of new drugs and the development of Phase II and III require a better~     understanding of the state of this disease in the country.~      The main objective is to describe the characteristics of the pancreatic adenocarcinoma at~     diagnosis in France and make an inventory of diagnostic practices and support.~   "
81580|NCT01989611|"~     A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the~     acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine /~     tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and~     transgender women . The demonstration project aims to include 400 participants over 12~     months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.~   "
81581|NCT01989598|"~     This phase II trial studies how well trametinib and Akt inhibitor GSK2141795 work in~     treating patients with multiple myeloma that has come back (relapsed) or that does not~     respond to treatment (refractory). Trametinib and Akt inhibitor GSK2141795 may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
81582|NCT01989585|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients~     with v-raf murine sarcoma viral oncogene homolog B (BRAF) mutant melanoma or solid tumors~     that have spread to other parts of the body or cannot be removed by surgery. Dabrafenib,~     trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
81583|NCT01989572|"~     This randomized phase III trial studies sargramostim (Granulocyte-macrophage~     colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work~     compared to sargramostim and vaccine therapy together in preventing disease recurrence in~     patients with locally advanced or stage IV melanoma that has been removed by surgery.~     Sargramostim may stimulate the immune system in different ways and stop tumor cells from~     growing. Vaccines made from peptides may help the body build an effective immune response to~     kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy~     are more effective alone or together in preventing recurrence of melanoma.~   "
81584|NCT01989559|"~     This pilot clinical trial studies booster vaccination in preventing disease recurrence in~     previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made~     from peptides may help the body build an effective immune response to kill tumor cells.~     Giving booster vaccinations may make a stronger immune response and prevent or delay the~     recurrence of cancer.~   "
81585|NCT01989546|"~     Background:~        -  The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining~          genomic stability by regulating a variety of DNA damage repair mechanisms.~        -  BMN 673 is a PARP inhibitor with greater in vitro activity than any other PARP~          inhibitor currently in development. BMN 673 has been shown to cause single-agent~          synthetic lethality in BRCA1/2- and PTEN-deficient cell lines, and has potent antitumor~          activity in animal models of tumors harboring mutations in DNA repair pathways.~        -  BMN 673 is showing promising single-agent activity in patients with advanced ovarian~          and breast cancer harboring deleterious BRCA mutations.~        -  This pilot study will evaluate the pharmacodynamic effects of BMN 673 on DNA damage and~          apoptosis markers in tumor biopsy tissue.~      Primary Objective:~      -Determine the pharmacodynamic effect of BMN 673 in tumor biopsies from patients with~     advanced ovarian, breast, or other solid tumor and deleterious BRCA mutations.~      Secondary Objectives:~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced ovarian or primary peritoneal carcinoma and deleterious BRCA mutations.~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced breast carcinoma and deleterious BRCA mutations.~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced solid tumor (other than breast or ovarian) and deleterious BRCA mutations.~      Eligibility:~        -  Adult patients with documented deleterious BRCA 1 or 2 mutations with histologically~          confirmed ovarian, primary peritoneal, breast, prostate, pancreas, gastric or other~          solid tumor whose disease has progressed following at least one standard therapy or who~          have no acceptable standard treatment options.~        -  No major surgery, radiation, or chemotherapy within 4 weeks prior to study enrollment,~          and recovered from toxicities of prior therapies to at least eligibility levels.~        -  Age greater than or equal to 18 years of age; ECOG performance status less than equal~          to 2~        -  Adequate organ function.~        -  Willingness to undergo tumor biopsies.~      Study Design:~        -  BMN 673 will be administered orally each day in 28-day cycles.~        -  Dosing will be at the established recommended Phase II dose of 1000 mcg/day each day~          for~           28 days.~        -  We plan to accrue a total of 12 evaluable patients per cohort for a total of 36~          patients. To allow for some patients who will not be evaluable, the accrual ceiling is~          42 patients.~        -  Tumor biopsies will be mandatory at baseline (pre-dose), and then approximately 3-6~          hours post BMN 673 on day 8. An optional tumor biopsy may also be collected at time of~          disease progression.~      SCHEMA~        -  BMN 673 is administered orally each day in 28-day cycles~        -  Tumor biopsies will be performed at baseline (pre-treatment) and 3-6 hrs post dose on~          cycle 1 day 8. An optional tumor biopsy may also be collected at time of disease~          progression. Tumor biopsies will be evaluated for PAR levels, DNA damage response~          markers such as >=H2AX, cleaved caspase 3, ERCC1, pNbs1, XPF, RAD51, and pT1989ATR,~          and, as indicators of ATR/ATM activation, chk1 and chk2~        -  Blood samples for CTC analyses will be collected at baseline (pre-treatment), on cycle~          1 day 1(3-6 hours post dose), on cycle 1 day 8 (3-6 hours post dose), and on cycle 2~          day 1 (3-6 hours post dose)~        -  Blood samples for PK analysis will be collected on cycle 1 day 1 pre-dose and 0.5, 1,~          2, 3, 4, 6,8, and 24 hours post-dose, on cycle 1 day 8 (3-6 hours post dose), and on~          cycle 2 day 1 predose and 3-6 hours post dose.~   "
81586|NCT01989533|"~     Background:~      - Vaccines create resistance to disease. This study tests experimental human~     immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters~     may help vaccines stimulate an immune response against HIV. This means the body works to~     fight infection. Researchers want to see if different ways of giving the vaccines cause~     different immune responses. They also want to see if the vaccines adenovirus is contagious.~     Adenoviruses cause cold symptoms or mild eye infections.~      Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their~     entire household and intimate contacts must participate.~      Objective:~      - To test the safety of experimental HIV vaccines.~      Eligibility:~      - Healthy adults 18 49 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will receive the vaccine 3 times over 6 months. Each time, they will have~          a physical exam and blood and urine tests. Samples will be taken from their nose,~          rectum, and cervix.~        -  Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic~          staff will observe them for 1 hour.~        -  Some participants will receive the vaccine swabbed in their throat. They will get dose~          1 at the hospital and stay there for 1 week. They will have medical tests and nose~          swabs. Doses 2 and 3 will not require a hospital stay.~        -  Participants will have 7 follow-up visits over 6 months, with a physical exam and blood~          tests. Samples will be taken from their nose, throat, and rectum.~        -  Household and intimate contacts will have 4 clinic visits over 8 months, with a~          physical exam and blood tests.~   "
81587|NCT01989520|"~     Study to investigate relative bioavailability of up to five different formulations of~     AZD5069~   "
81588|NCT01989507|"~     The purpose of this study is to determine the efficacy, acceptability and unintended~     consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past~     year substance use disorders (SUD). The primary aim of this study is to determine whether 6~     weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more~     smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of~     toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of~     substance use and substance cravings (drugs and alcohol) because this is relevant to the~     safety of these products among smokers with SUD. Secondary aims are to study effects on~     cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random~     assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender,~     degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided~     with smoking counseling. Assessments over 6 months will assess effects both during the 6~     weeks of using research cigarettes and after return to usual cigarettes. The importance is~     in determining the viability and safety of this public health strategy in terms of effects~     on both smoking and other substance use in a highly addicted population, which is essential~     to determine before the FDA implements this policy.~   "
81589|NCT01989494|"~     This study will measure and compare the physical activity of the anesthesiologists during~     routine daily work in the operating room as determined by the pedometer-counted steps and to~     estimate the average daily physical activity by using a seven day exercise recall survey.~   "
81590|NCT01989481|"~     The purpose of this observational study is to investigate the preoperative and operative~     factor of pain and functional outcome at one years following total knee arthroplasty and~     spinal surgeon.~   "
81591|NCT01989468|"~     The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,~     as well as up to 3-year efficacy, safety and tolerability data in subjects with active~     Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),~     disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis~     factor alpha (TNFα) therapy.~   "
81592|NCT01989455|"~     Single center, randomized, double-blind, placebo-controlled, adaptive sequential~     ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of~     single doses of deferiprone administered by intravenous infusion to healthy males and~     females. A bioavailability comparison will be included.~   "
81593|NCT01989442|"~     The study aims to investigate efficacy and safety of nasal mask and prongs used in~     non-invasive ventilation in newborns by using esophageal pressure transducer.~      The parameters including ventilation duration, hospitalization duration, pulmonary outcomes~     and side effects will be evaluated.~   "
81594|NCT01989429|"~     M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of~     plaque psoriasis and is being developed as a topical ointment formulation (M518101)~      Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque~     psoriasis.~      Based on the results of previous phase II trials the phase III trial has been designed to~     evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger~     population of patients with stable plaque psoriasis.~   "
81597|NCT01989364|"~     Background: The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging~     (DWI-MR) has been shown to correlate with cellular density. The ADC is indicative of Gross~     Tumour Volume (GTV), and preliminary data shows that the dynamics of DWI volumes during~     treatment (shrinkage) as well as dose to DWI volumes has impact on treatment outcome.~      Hypoxic tumour cells within the primary tumour have been identified to have prognostic~     importance for local control Tumour hypoxia is caused by insufficiency of the tumour~     vasculature leading to both chronic diffusion limited and acute flow limited hypoxia.~     Radioresistant hypoxic cells diminish the rate of local control, and the hypoxia driven~     increase in metastatic potential of the tumour and lowers the rate of distant disease~     control. Functional imaging has the potential to visualise radioresistant tumour subvolumes.~     PET scanning (18F-FAZA) is hypothesized to visualise hypoxic tumour subvolumes, and dynamic~     contrast enhanced (DCE) MR imaging has been used to quantify the extent of poor perfusion~     regions within cervical tumours.~      Objectives:~      Primary:~      Sensitivity and specificity of functional imaging (18F-FAZA PET (optional), T1w, T2w,~     DWI-MRI and DCE-MRI) to identify tumours with good and bad response to radio-chemotherapy~      Secondary:~      Determining whether there are differences in bias between centre. The difference in bias~     will be assessed for the T1 and T2 scans and the Ktrans and ADC maps.~   "
81598|NCT01989351|"~     The study purpose is to examine polymorphism of genes associated to post-operative~     persistent pain and to verify the possible association between genotype phenotype and ADRB2~     polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2~     in VAS>4 patients and to compare it to those with VAS<4.~   "
81599|NCT01989338|"~     To investigate relationship between HV deformity and position of rearfoot joints, and its~     effects on the quality of life, pain, and related functional status in women with bilateral~     hallux valgus (HV).~   "
81600|NCT01989325|"~     This is a Phase 2 study during which patients with advanced multiple myeloma will receive~     either carfilzomib alone (single-agent) or carfilzomib in combination with investigational~     study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of~     both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will~     be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease~     progression occurs. Approximately 75 patients from the US will be enrolled in this study.~   "
81601|NCT01989312|"~     The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial~     plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block~     alone.~      Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular~     only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S~     will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of~     lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve~     blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and~     motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every~     5 minutes starting at the 10th minutes. The imaging, needling and performance times will be~     recorded. Also the onset and anesthesia related times, need for analgesic and first~     analgesic time will be noted.~   "
81602|NCT01989299|"~     Heart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which~     no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac~     death is suggested as the most common cause of death in HFPEF patients, although data is~     sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to~     evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular~     tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter~     Defibrillator (ICD) may be an option in the future.~   "
81603|NCT01989286|"~     The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of~     this study is to evaluate the spine, the posture and the psychomotor state in children who~     were diagnosed with infant plagiocephaly.~   "
81604|NCT01989273|"~     This is a study of patients admitted with major traumatic injuries. Such patients may~     develop inadequate circulation to the organs as a result of internal blood loss. Early~     detection of internal blood loss can be difficult as physical examination alone may miss~     patients with significant blood loss. Some patients with internal bleeding will arrive with~     low blood pressure; these patients are usually given 2 liters of intravenous fluid to~     determine if their blood pressure will recover. If the blood pressure does not rise or if it~     drops again later, the blood loss can be assumed to be severe, and the patient will likely~     need transfusions, surgery and other interventions. However, this fluid treatment method can~     lead to delays and complications as some patients may initially respond but then continue to~     bleed. The inferior vena cava (IVC) is the large vein draining blood from the lower body to~     the heart. The inferior vena cava is known to empty when the patient has had significant~     blood loss. The vena cava diameter can be seen using ultrasound. This study intends to~     perform ultrasound to examine the vena cava diameter on patients just after arriving with~     major trauma. The hypothesis of the proposed study is that an ultrasound assessment protocol~     of inferior vena cava diameter and collapsibility can detect and aid management of~     non-compressible hemorrhage in major trauma victims. After the patient has been given the 2~     liter intravenous fluid treatment, the inferior vena cava diameter will be measured again. A~     third examination 8-24 hours after admission will determine if the inferior vena cava~     diameter has returned to normal. We propose that measuring the inferior vena cava in this~     manner can predict those patients who are likely to continue bleeding and require~     interventions such as surgery. Early detection in these patients may avoid delays in~     treatment, complications and excess mortality. Because this examination is done with~     handheld ultrasound machines, it could be done outside hospitals and in military combat~     casualty care.~   "
81605|NCT01989260|"~     Endometriosis is a common gynaecological condition which typically present with pelvic pain~     and fertility problems. It is caused by tissues which are similar to the lining of the womb~     growing inside the women's pelvis. Severe endometriosis is most effectively treated using~     keyhole surgery. During the operation, endometriosis tissue is removed. However, following~     successful removal of endometriosis, women may still experience pain because the ovaries~     sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want~     to see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative~     scarring.~   "
81606|NCT01989247|"~     The purpose of this study is to investigate whether citizens experiencing symptoms of~     anxiety and depression will benefit from a self-management training program with respect to:~     1) Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures~     of Health Related Quality of Life (HRQoL)~   "
81634|NCT01988883|"~     A common complaint among patients with Postural Tachycardia Syndrome (POTS) is brain fog~     or difficulty concentrating. This problem is poorly understood.~      The purpose of this study is to better understand the cognitive dysfunction associated POTS,~     and to determine optimal treatment strategies for this condition. In this study, the~     investigators will test the hypothesis that acute administration of the psychostimulant drug~     modafinil can improve seated measures of cognitive function in patients with POTS.~   "
81607|NCT01989234|"~     This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811~     capsules in patients with chronic idiopathic constipation. Following a 2-week baseline~     period, approximately 320 eligible patients with <3 complete spontaneous bowel movements~     (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the~     following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by~     a 2 week follow-up period.~      The objectives of this study are:~        -  To assess the efficacy of YKP10811 once daily at relieving constipation and associated~          symptoms in subjects with chronic idiopathic constipation.~        -  To determine the safety and tolerability of YKP10811 once daily in subjects with~          chronic idiopathic constipation.~   "
81608|NCT01989221|"~     The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal~     system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with~     gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms~     of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients~     with diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The~     Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the~     severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will~     then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily~     basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso®~     treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be~     compared to symptoms after the first week and the second week of treatment. Thirty patients~     diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic~     gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study~     is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in~     gastroparesis patients. Safety information will also be collected regarding any adverse~     effects. If the results are encouraging, as we expect them to be based on personal~     experience, a larger double blind study would be appropriate.~   "
81609|NCT01989208|"~     Patients with heart failure are reported to have lower levels of hydrogen sulfide in their~     blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule~     that has been shown to have a number of beneficial effects and thus the low levels may~     contribute to the disease. This trial is testing whether a medical food product of synthetic~     sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.~   "
81610|NCT01989195|"~     The investigator hopes to introduce a novel MRI contrast agent with SeeMore ™ that directly~     defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is~     still a moving target and a question we plan to answer more definitively with the SeeMore ™~     contrast. Though well tested in small and large animals and Phase I & II clinical trials,~     the investigators would like to determine the efficacy of the SeeMore contrast further in a~     clinical setting.~      SeeMore is a new manganese (Mn)-based intravenous imaging agent being developed to enhance~     magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic~     and kinetic properties for MRI, use in humans was not initially possible due to~     cardiovascular depression and electrocardiogram (ECG) changes, including prolongation of PR~     and QTc intervals, associated with intravenous administration [1-5]. SeeMore provides Mn in~     a form that maintains the desired magnetic and kinetic properties while overcoming the~     cardiovascular toxicity of Mn. SeeMore is taken up into heart cells (primarily via addition~     of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The~     potential to distinguish healthy heart tissue from unhealthy heart tissue based on a~     specific sustained pattern of enhancement provides a basis for evaluating the performance of~     SeeMore in heart patients. It may be possible to enhance the utility of MRI for heart~     disease through the use of an imaging agent that is specifically taken up into heart cells.~     SeeMore is the only cardiac-specific agent being developed for this purpose. Unlike nuclear~     perfusion agents, SeeMore is not radioactive and does not require special handling,~     shielding, transport or storage. In addition, the specific pattern of enhancement achieved~     in the heart muscle persists over time, offering potential benefits over the nonspecific~     extracellular agents currently available for MRI or X-ray/CT procedures. This feature allows~     full use of the high resolution of MRI, since there is not a trade-off of high spatial~     resolution for temporal (first-pass) resolution. It is anticipated the features offered by~     SeeMore along with the high resolution, three dimensional attributes of MRI will result in~     higher accuracy than is available with other current modalities in practice, including~     stress echocardiograms, cardiac MRI using gadolinium contrast and nuclear studies such as~     SPECT and PET. This will be evaluated in this study and serve as the basis for pivotal~     registration studies.~      All components of SeeMore™ are USP and are approved for use as drugs in man, orally and/or~     intravenously.~   "
81611|NCT01989182|"~     This is a multicenter, prospective, randomized, controlled study being conducted in China to~     evaluate improvement of lung function after treatment with the Spiration Valve System as~     compared to medical management in the control group. The control group will be evaluated in~     the same manner as the treatment group.~      The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the~     airways of one lung. It is used to redirect air from the less healthy to the more healthy~     parts of the lung. This helps to reduce over-inflation and may improve overall lung function~     and quality of life for people living with emphysema.~   "
81612|NCT01989169|"~     A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in~     Healthy Adult Subjects~   "
81613|NCT01989156|"~     The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol~     (mTHS) for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently~     adult healthy smokers results in a reduction in the levels of biomarkers of exposure for~     selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing~     smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking~     abstinence (SA).~   "
81614|NCT01989143|"~     This single and multiple ascending dose study is a first in human assessment of PF-06480605.~     The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.~   "
81615|NCT01989130|"~     The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test~     results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia~     and to assess changes in clinician management decisions with real-time test results.~   "
81616|NCT01989117|"~     Osteopathy is an alternative healthcare that seems effective in relieving the pain of~     patients. The main purpose of this study is to evaluate the efficacy of preoperative~     osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis.~     The secondary objectives are to assess pain during the first postoperative month on a VAS~     and knee function and quality of life at 6 months and 1 year. Our hypothesis is that~     osteopathy will decrease postoperative pain and increase knee function.~   "
81617|NCT01989104|"~     The purpose of this study is to measure and link cadence (number of steps taken in a minute)~     to intensity of physical activity (e.g., low-intensity, moderate-intensity,~     vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the~     cadence values corresponding to children's and adolescent's behavior during simulated~     free-living activities.~   "
81618|NCT01989091|"~     Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain~     catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in~     dialysis patients using a central venous catheter (CVC) for vascular access.~      The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a~     minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access.~     Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock~     or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or~     a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter~     lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the~     initiation of the next dialysis session.~      The primary objectives of this study are:~        -  To demonstrate the safety of B-Lock in dialysis patients~        -  To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of~          B-Lock relative to ACH with respect to maintaining catheter patency as defined by the~          use of recombinant tissue plasminogen activator for maintaining adequate blood flow~          through the dialysis catheter~        -  To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence~          of CLABSI~   "
81619|NCT01989078|"~     Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD)~     that begins in childhood and results in renal (kidney) failure and early mortality in nearly~     12% of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney~     damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage;~     however the correlations of albuminuria with specific measurements of glomerular function~     and pathophysiology have not been determined. The investigators hypothesize that in patients~     with persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse~     kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction~     in more advanced nephropathy. The primary aim is to study the acute and longer-term effects~     of losartan (study drug) on specific glomerular functions in children and adults with SCD~     who have persistent albuminuria. Research glomerular function tests will be done at study~     entry (prior to taking losartan), 1 month, and 1 to 2 years after starting losartan therapy~     (participants may take losartan for up to 24 months). In addition, participants are seen~     each month in clinic and assessed by their regular clinical team. The second aim is to~     assess the correlation of changes in albuminuria after 1 month of losartan with changes in~     direct measurements of glomerular function at 12-24 months, thus determining if the~     magnitude of the initial decrease in albuminuria in response to losartan predicts sustained~     improvements in renal function.~   "
81620|NCT01989065|"~     Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the~     health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy~     Lifestyles Program by delivering educational and supportive text messages to the parent's~     mobile device.~   "
81621|NCT01989052|"~     This is a Phase 1/2 study of the combination of CTO with lomustine in patients with~     recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center~     (PRTBTC) at Duke. The Primary Objectives are:~        -  Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with~          lomustine among patients with recurrent malignant glioma (World Health Organization~          (WHO) grade III or IV) who have not been previously treated with bevacizumab.~        -  Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with~          lomustine) compared to lomustine alone in patients with recurrent WHO grade IV~          malignant gliomas that have not been previously treated with bevacizumab based upon~          6-month progression free survival (PFS6).~      Note: This study was terminated early due to funding issues. At the time of termination, the~     study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been~     determined for this population. Phase 2 will not proceed.~   "
81622|NCT01989039|"~     FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total~     or central adiposity, increased insulin resistance and abnormal glucose metabolism.~     Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women~     with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity~     is per se associated with increased adipose expression and plasma levels of leptin, lower~     expression of adiponectin, and elevated inflammatory markers. To study the insulin~     resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight~     status should be considered. Investigator therefore conduct this retrospective study to~     evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and~     non-PCOS among obese and non-obese women.~   "
81623|NCT01989026|"~     Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This~     effect cannot be explained by prevention of tuberculosis, which is very rare among infants.~     The protective effect of BCG vaccination is seen already within the first week. It seems~     that BCG provides a non-specific beneficial immune modulation - thereby reducing overall~     mortality. Mortality is very high among newborns admitted to the neonatal intensive care~     unit. If BCG has immediate beneficial effects on the immune system, vaccinating children~     with BCG as early as possible may save lives. The investigators will test this hypothesis in~     a randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the~     neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge~     (usual practice).~   "
81624|NCT01989013|"~     We are studying & researching the effect of CranioSacral Integrative therapy on Parkinson's~     Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral~     integrative therapy for 90 minutes per session with a total of 2 session divided equally in~     a month (biweekly intervention). At the end of 3 months each patient will have total of 9~     hours of CranioSacral Integrative therapy induced, we will document the symptoms and~     shortcomings of the patients at evaluation, before and after therapeutic treatment on a~     measured scale ranging from 1-10. Finally graphically and statistically measure the quality~     of change in the symptoms at the end of 3 months and provide executive summary of the~     research finding, which the investigators expect to be a positive one.~   "
81720|NCT01987726|"~     This pilot clinical trial studies comprehensive gene sequencing in guiding treatment~     recommendations in patients with metastatic or recurrent solid tumors. Studying samples of~     blood and tissue from patients with cancer in the laboratory may improve the ability to plan~     treatment.~   "
81625|NCT01989000|"~     Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline~     resectable disease may benefit from preoperative radiochemotherapy. However, only a subset~     of patients will respond to this potentially toxic and expensive treatment. Therefore, novel~     predictive markers are needed to determine treatment efficacy at an early stage. Preferably,~     these markers could be determined non-invasively and provide insight into the biology of~     pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment~     is often characterized by large amounts of stroma, hypovascularization, and hypoxia. As~     these three factors can all contribute to treatment resistance, a quantitative assessment of~     these markers may aid in the prediction of response to preoperative radiochemotherapy.~     Moreover, these assessments may have prognostic value. Finally, further insight into the~     interrelation of these aspects of the tumor microenvironment can contribute to the~     evaluation of new targeted treatment options. Tumor cellularity and extracellular matrix~     composition can be assessed non-invasively in vivo by diffusion weighted magnetic resonance~     imaging (DWI) and tumor vascularity can be assessed by dynamic contrast enhanced magnetic~     resonance imaging (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT,~     using the 18F-labeled hypoxic marker HX4.~      Objective of the study:~      The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT~     predict overall survival in patients with pancreatic cancer treated with surgery and~     adjuvant chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant~     chemotherapy. Secondary aims of the study include the assessment of the predictive value of~     DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant~     chemoradiation, the correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with~     histopathological assessment of tumor stroma, vascularization, and hypoxia, and the~     assessment of the predictive value of these histopathological markers for overall survival.~   "
81626|NCT01988987|"~     Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated~     with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to~     30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after~     delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is~     essential because serious health problems can result.~      Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks~     after delivery for women diagnosed with GDM in order to identify those with continued DM or~     impaired glucose metabolism. However, approximately half of these women do not get glucose~     testing after delivery. The ability to test women while they are still hospitalized after~     having a baby could greatly increase diagnosis, care and treatment of women with abnormal~     glucose metabolism.~      Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to~     four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks~     after delivery.~   "
81627|NCT01988974|"~     The purpose of this study is to determine the psychometric properties of the Knowledge,~     Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical,~     practical knowledge about the feasibility of conducting a randomized trial to test the~     effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of~     Atrial Fibrillation (AF).~   "
81628|NCT01988961|"~     The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe~     set panel (a genetic test) in predicting response to golimumab treatment in participants~     with moderately to severely active ulcerative colitis (UC).~   "
81629|NCT01988948|"~     Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The~     high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The~     introduction of vaccination against two major oncogenic genotypes of HPV raises questions~     about genotype replacement because of the existence of other oncogenic types not targeted by~     the vaccine. A better understanding of natural history of HPV infection and interaction~     (competition, synergy) between genotypes are required in order to anticipate this~     phenomenon.~      The aims of this study are to characterize HPV infection in young female students and to~     follow up HPV infection and co-infection dynamics with different genotypes, taking into~     account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the~     determination of factors influencing the development of persistent cervical HPV infections.~      The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from~     18 to 20 years-old, all registered at the Universities of Bordeaux or Versailles~     Saint-Quentin (UVSQ). The 3-years follow-up includes completion of a self-administrated~     questionnaire regarding sexual behaviour, socio-demographic characteristics, access to~     health-care services and, for a sub-group of 1000 students, the taking of genital and oral~     self-taken samples for the detection and genotyping of HPV (every 3 months). Previously, a~     pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students~     from UVSQ in order to test feasibility.~      This study will provide data to gain insight into the possibility of type replacement.~     Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV~     incidence and factors associated with HPV infection and co-infection ; Partners recruitment~     would allow us to follow HPV transmission dynamics among couples, and in particular, HPV~     exposure in young adult women. The HPV research won't be limited to virus detection in~     samples but will indicate the presence or absence of HPV infection.~      Finally, additional genetic studies could be conducted in order to study genetic~     susceptibility to HPV infection, to chronic HPV infection and to co-infection.~      This research project is part of the i-Share program funded by the Investissement d'Avenir~     cohort call.~   "
81630|NCT01988935|"~     Research shows that people with PTSD are more likely to smoke than people without PTSD. It~     also shows that people with PTSD have more difficulty at attempts to quit smoking. This~     study is part of a program aimed at finding out how best to help smokers quit who also have~     PTSD. One option is to give patients standard smoking cessation treatment including nicotine~     replacement and cognitive behavioral therapy. Another option is to give patients the~     standard smoking cessation treatment in addition to treatment for their PTSD symptoms~     (called prolonged exposure). However, it is not known which method works better. In order to~     answer this question, patients will be assigned by chance to one of two groups. One group~     will be given standard smoking cessation treatment to help quit smoking. A second group will~     be given the standard smoking cessation intervention to help quit smoking in addition to a~     form of psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients~     will be randomly assigned (by chance) to one of these groups. If the patient is assigned to~     the smoking cessation only condition and the patient still has PTSD symptoms after the last~     study visit (week 30) the patient will be offered treatment for your PTSD symptoms~     (Prolonged Exposure) at no cost. The patient's participation will help the investigators~     determine if treating PTSD symptoms enhances the ability of standard smoking cessation to~     help people quit smoking.~   "
81631|NCT01988922|"~     This research study will determine if genetic variation in CYP2B6 affects how the body~     metabolizes ketamine.~   "
81632|NCT01988909|"~     The objectives of the study are to evaluate the safety and efficacy of open label treatment~     with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated,~     non-severe cutaneous leishmaniasis (CL).~   "
81633|NCT01988896|"~     A Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and~     pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an~     engineered anti-programmed death-ligand 1 [anti PD-L1] antibody) and oral dosing of~     cobimetinib in participants with metastatic or locally advanced cancer for which no standard~     therapy exists.~   "
81739|NCT01987479|"~     This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and~     efficacy of RoActemra/Actemra alone or in combination with non-biologic disease modifying~     antirheumatic drugs (DMARDs) in rheumatoid arthritis patients with an inadequate response to~     non-biologic DMARDs~   "
81635|NCT01988870|"~     The purpose of this study is to evaluate an investigational way to provide radiation therapy~     to treat breast cancer at the time of surgery.~      Traditionally, the recommended treatment for early stage breast cancer is surgery to remove~     the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence~     of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and~     can be associated with damage to other tissues including the skin. Recent technological~     advances have made it possible to provide radiation treatment during the breast cancer~     surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The~     University of Virginia has a unique IORT system which allows for the inclusion of cutting~     edge imaging technology into the IORT procedure in order to provide delivery of radiation~     directly to the needed areas and to avoid radiation to other tissues.~   "
81636|NCT01988857|"~     This study will evaluate the safety and reactogenicity of GSK Biologicals' combined~     reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™~     when given as a single injection to 6-10 year old children. Data that are available globally~     on the age group from four to six years of age will be used to bridge the age gap in this~     study and aid in the registration of the vaccine for children from the age of four years.~   "
81637|NCT01988844|"~     Cerebral palsy is the leading cause of physical disability among children. Manual dexterity~     and upper limbs functionality is limited between these children. The purpose of this study~     is to stablish a specific profile of school children with cerebral palsy based on the upper~     limbs assessment.~   "
81638|NCT01988831|"~     Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to~     an earlier detection of the primary tumour and a better prognosis, but melanoma remains an~     aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies~     compared groups of patients diagnosed with primary melanoma and treated with betablockers~     for another indication to patients who never received betablockers. In these three studies,~     the outcome of the disease is significantly better for people under betablocker treatment~     with a decreased rate of recurrence and a better 5 years survival rate. Here we want to~     investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for~     patients suffering from a primary melanoma with a high risk of recurrence.~   "
81639|NCT01988818|"~     The primary objective of this investigation is to evaluate the performance of a~     self-adhesive absorbent post-operative dressing coated with a soft silicone layer in~     minimize the risk of the development of blistering in subjects after hip or knee~     arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary~     objectives are to evaluate:~        -  the performance of the dressing~        -  the comfort, conformability and the acceptability of the dressing~        -  pain before, during and after dressing removal~        -  the overall cost regarding dressing wear time, time to do dressing change and personal~          resources needed~   "
81640|NCT01988805|"~     This study is intended to collect blood from healthy individuals to investigate whether~     variations in immune-related (inflammasome) genes affect how the immune cells found in the~     blood can help fight infections and prevent diseases.~   "
81641|NCT01988792|"~     The purpose of this study to find out how safely we can add extra nutrients to human milk at~     different feeding volume.~   "
81642|NCT01988779|"~     The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis~     (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms~     and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral~     antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice~     daily intranasal antibiotic irrigations. The two treatments will be compared to see if there~     is any difference in patient outcomes. This will help guide treatment strategies for~     patients with CRS in the future.~   "
81643|NCT01988766|"~     The purpose of this study is to compare the difference in thrombosis as a result of internal~     jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is~     hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ~     catheters verses PICC lines.~   "
81644|NCT01988753|"~     This study is being conducted to develop new techniques for early diagnosis of liver~     disease. These techniques are: Shearwave Elastography (SWE) ultrasound and blood biomarkers.~      SWE ultrasound uses high-frequency sound waves to view soft tissues such as muscles and~     internal organs and measure stiffness. An ultrasound creates computer images that show~     internal body organs, such as the liver or kidneys, more clearly than regular x-ray images.~      Biomarkers are biological molecules found in the blood that provide important information~     about liver disease.~   "
81645|NCT01988740|"~     The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy~     suggests a role for IMA as a potential biomarker for abnormal placental development related~     to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent~     pregnancy loss (RPL).~   "
81646|NCT01987895|"~     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin~     in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
81647|NCT01987882|"~     The primary purpose of the project is to evaluate the effectiveness of different~     intervention strategies to prevent or relieve symptoms associated with hip instability in~     children with severe cerebral palsy, using the validated Caregiver Priorities and Child~     Health Index of Life with Disabilities (CPCHILD©) questionnaire as the primary outcome~     measure of health-related quality of life for this population.~   "
81648|NCT01987869|"~     Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis~     gravid arum.~   "
81659|NCT01988597|"~     Dry eye syndrome is a very common condition with multiple etiologies that includes systemic~     and ocular disease that causes reduction in the production of tears, as well as increase in~     tears evaporation. As a result of the various etiologies and large variability of dry eye's~     clinical sign, it has been a challenge for practitioners to have a consistent system to~     classify dry eyes and to have an appropriate and accurate measurement to quantify the~     severity of dry eyes and its impact on patients' quality of life.6 To date, no study which~     evaluates the extent of questionnaires correlates with changes in quality of life. With this~     cross sectional interview study, we aim to determine the efficacy of the questionnaires as a~     practical tool in our future clinical trials at our center.~   "
81649|NCT01987856|"~     Single embryo transfer (SET) has been advocated as a means of reducing the risk of multiple~     pregnancies, but has meant a reduction in pregnancy risk per embryo transfer. Embryo~     aneuploidy has been cited as the primary reason for the low embryo implantation achieved in~     human IVF. In the majority of IVF programs embryo selection has mainly been based on the~     microscopic assessments embryo. Culturing embryos to the blastocyst stage as a selection~     mechanism has seen an increase in implantation rates, presumably indicating that~     morphologically normal blastocysts formed by day 5 of culture may have a reduced aneuploidy~     rate. Morphological normality does, however, not completely preclude aneuploidy, with many~     transferred and cryopreserved embryo bearing factors that may hold an increased risk for~     implantation failure and miscarriage.~      To select the conditions for single blastocyst transfer that will significantly improve~     reproductive outcomes; increased implantation, reduced pregnancy loss and increased live~     birth rates.~   "
81650|NCT01988714|"~     The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive~     training combined with community-based supported employment for people with schizophrenia.~     The investigators will examine the effectiveness of moving our study of~     neuroplasticity-based restorative targeted cognitive training out of the laboratory and into~     the community setting; and the investigators will also investigate its utility in enhancing~     functional outcome in chronically mentally ill adults who are participating in supported~     employment.~   "
81651|NCT01988701|"~     This research trial studies lymphocyte profiles and activation status in patients with~     graft-versus-host disease. Studying samples of blood in the laboratory from patients with~     cancer may help doctors identify and learn more about biomarkers related to~     graft-versus-host disease.~   "
81652|NCT01988688|"~     This study will test the safety and effectiveness of deep brain stimulation (DBS) for~     patients with a big or very big problem with tinnitus (a sensation of noise in the head).~   "
81653|NCT01988675|"~     This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early~     changes in white matter (in the brain) and the blood-brain barrier resulting from radiation~     therapy.~   "
81654|NCT01988662|"~     This study will assess systemic VEGF level in patients with neovascular Age-related Macular~     Degeneration following treatment with Ranibizumab or Aflibercept~   "
81655|NCT01988649|"~     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In~     addition,oxytocin have an important roles in sexual reproduction , in particular during and~     after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin~     has been commonly used to improve breastfeeding in lactating women. A review of safety ,~     side effects and subjective reaction to intranasal oxytocin in human research in 1529~     subjects did not review any differences from placebo. The vast majority of basic science~     studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have~     demonstrated an association between plasma levels of oxytocin and pain in humans. No studies~     have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since~     addictive properties of oxytocin have not been described, the drug may have important~     application in the management of acute and chronic pain.~      The main objective of the current investigation was to evaluate the effect of intranasal~     oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that~     intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain~     threshold compared to intranasal saline .~      Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain~     in humans.~   "
81656|NCT01988636|"~     Background:~      - Malaria is caused by small germs carried by mosquitoes. People can get malaria if an~     infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the~     blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year.~     About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to~     find a safe vaccine that helps prevent malaria.~      Objectives:~      - To see if a new malaria vaccine is well tolerated and effective.~      Eligibility:~      - Healthy adults 18 35 years old who are not pregnant and live in Mali.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood test. They~          will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record~          the heart s electrical signals.~        -  Study participation will last about 1 year.~        -  Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ~          vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses~          of placebo.~        -  Doses will be given through a needle in the arm directly into the bloodstream. Then~          participants must stay at the clinic for 2 hours.~        -  After each dose, participants will return to the clinic several times for blood tests~          and physical exam.~        -  A week before the first dose and 2 weeks after the last, participants will take a full~          course of anti-malaria drugs.~        -  If a participant gets malaria during the study, they will take another course of~          anti-malaria drugs.~   "
81657|NCT01988623|"~     The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the~     treatment of communication deficits in children with intellectual disabilities. By~     collecting information about parent and child functioning before and after PRT, The~     investigators will be able to determine whether the intervention is effective in improving~     child communication and reducing parent stress.~   "
81658|NCT01988610|"~     The purpose of this study is to study the effect of cortisol,a stress hormone in the body,~     on memory and attention in people with a history of depression, but who are not in the midst~     of a current depressive episode.~      Cortisol may affect parts of the brain associated with memory and attention directly. It may~     also indirectly affect the brain by controlling how much insulin the body makes. Insulin is~     thought to impact cognition by changing the amount of sugar available in certain parts of~     the brain.~      The investigators are studying this question by giving patients a medication, called~     Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare~     results from several groups of people, including differences between men and women, and~     between those with and without insulin resistance.~   "
81786|NCT01986868|"~     This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can~     identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other~     substances found in the blood) seen on coronary computed tomography angiography(CCTA) and~     evaluate whether there is a relationship between the adverse plaque characteristics and the~     presence of coronary artery wall inflammation.~   "
81660|NCT01988584|"~     The purpose of this study is to compare the safety and effectiveness of two types of stem~     cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10~     years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord~     blood will be enrolled into the study. The study involves one baseline/treatment visit and 3~     follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be~     randomized to a placebo control group at the baseline/treatment visit. Parents will not be~     told if their child received stem cells or a placebo until the 12 month follow-up visit. At~     that time parents may elect to have their child receive the stem cell treatment; either bone~     morrow harvest or umbilical cord blood if banked with CBR. All study visits will be~     conducted at the UTHealth Medical School and Children's Memorial Hermann Hospital in~     Houston, Texas.~      As of 1/21/2014 we have met our enrollment limit for children without banked cord blood~     undergoing bone marrow harvest for stem cells.~   "
81661|NCT01988571|"~     The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily~     decreases the chance of developing heart problems in women receiving adjuvant~     anthracycline-based chemotherapy for breast cancer.~   "
81662|NCT01988558|"~     The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and~     preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.~   "
81663|NCT01988545|"~     to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and~     cardiac parameters~   "
81664|NCT01988532|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess the impact of pain on functional impairment and quality of life in adult persons with~     hemophilia (PWH) with and without inhibitors with joint bleeding.~   "
81665|NCT01988519|"~     Pancreatic resection is the only potentially curative modality of treatment for pancreatic~     neoplasm. The mortality associated with this procedure decreased rapidly in the past~     decades. However, the morbidity associated with pancreatic resection remains high. The main~     reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is~     regarded as the most ominous complication following pancreatic resection. Its reported~     incidence varies in the surgical literature from 10% to >30%.~      Recently published studies showed that the placement of intraoperative drains, manipulation~     with the drains, timing of removal of the drain, and especially the type of drain, have~     significant effect on the postoperative complications, and especially POPF.~      Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two~     most commonly used systems are closed suction drainage and closed gravity drainage. Open~     systems have been abandoned in most centers as they are obsolete.~      Our hypothesis is that the closed suction drain will have better results as it is more~     effective than the gravity drainage. However, some surgeons claim that the suction system~     can actively suck the pancreatic juice through the anastomosis or suture and thus promote~     the development of POPF.~      The aim of this study is to compare closed suction drains and closed gravity drains after~     pancreatic resection in a randomized controlled study.~      The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point~     is the postoperative morbidity.~   "
81666|NCT01988506|"~     TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in~     a set of 12 autoimmune and auto-inflammatory diseases, with the aim to select diseases in~     which further therapeutic development will be performed. Extensive biological- and~     immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct~     processes responsible for the breakdown of immunological tolerance in these pathologies and~     (ii) to discover potential biomarkers of the IL2 response.~   "
81667|NCT01988493|"~     This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2~     dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as~     first-line treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer~     (BCLC) Stage C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and~     Child-Pugh class A liver function.~   "
81668|NCT01988480|"~     The objective of this study is to compare two surgical procedure to place implant in~     severely resorbed posterioir part of the maxilla.~   "
81669|NCT01988467|"~     The aim of this study was to compare the acute effects of second hand smoke exposure between~     nasal and oral breathing and to assess the potential protective role of the nose during~     acute exposure, in exposure conditions similar to those within a bar where smoking is~     permitted.~   "
81670|NCT01988454|"~     The primary objective of this pilot study is to characterize the profile of lipoprotein,~     inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as~     compared to normal-weight age-matched controls.~   "
81671|NCT01988441|"~     Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver~     disease worldwide. It is not known why only some obese subjects develop NAFLD. In recent~     years, a growing body of evidence showed a crucial role of autophagy in in the regulation of~     liver fat storage. The purpose of this study is to determine whether autophagy~     pathway-related genetic polymorphisms affect NAFLD.~   "
81679|NCT01988337|"~     This is a three year single site clinical evaluation of a FDA approved (510(k):K100062)~     lesion penetrating resin used to infiltrate and hamper progression of proximal carious~     lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon,~     Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The~     study is designed as a randomized, controlled, prospective clinical trial with a three year~     follow-up evaluation period.~      The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2~     study lesions. The patients will be evaluated at six time points over a period of 3 years.~     Lesion status and caries risk will be monitored at 6-month intervals, while radiographic~     evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.~   "
81693|NCT01988155|"~     The purpose of this research study is to determine if Astym® treatment is an effective~     treatment for patients with Achilles pain. The usual treatment for this condition is a~     specific exercise program that has been previously shown to be effective. The research team~     is trying to determine if combining Astym with the exercise program is more effective than~     exercise program only.~      The main hypothesis for this study is that Astym plus eccentric exercise will be more~     effective than eccentric exercise alone at improving pain and function in patients with~     insertional Achilles tendinopathy.~   "
81672|NCT01988428|"~     Sepsis is one of the most frequent reasons for referral to emergency departments (EDs)~     worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a~     tendency to become more serious when left untreated with a high mortality rate, exceeding~     even those of myocardial infarction and stroke. Therefore, much effort has been put in to~     start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in~     the emergency department with fluid resuscitation, administration of~     vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and~     septic shock has indeed decreased mortality substantially. Emergency medical services (EMS)~     personnel have already made a significant difference in improving care for patients with~     acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic~     shock could also benefit greatly from timely pre-hospital care. Earlier recognition and~     initiation of treatment by EMS personnel may improve survival even more.~      Interestingly, the first hour of ED presentation seems to be the most critical hour.~     Administration of antibiotics and fluid resuscitation in the pre-hospital setting will~     reduce the time to administration substantially. In adults, to the best of our knowledge, no~     studies on the effect of pre-hospital administration of antibiotics have been performed. In~     children with meningitis, some uncontrolled studies show contradictory results, most~     probably due to bias by severity. We propose a non-blinded randomised multicentre clinical~     trial study on the efficacy of early, pre-hospital intravenous administration of broad~     spectrum antibiotics (ceftriaxone), which are effective against a wide variety of infectious~     pathogens that cause most common community-acquired infections) in patients referred to the~     ED with suspected severe sepsis or septic shock.~      Objective: To evaluate whether early, pre-hospital administration of antibiotics, together~     with training of ambulance personnel in recognizing and initiating treatment reduces 28-day~     mortality in patients referred to the ED with suspected severe sepsis or septic shock~      Study design: Non-blinded randomized multicentre clinical trial nested within a stepped~     wedge design~      Study population: All patients above the age of 18 years, with suspected severe sepsis or~     septic shock and transferred to the ED by ambulance, are eligible for study inclusion~      Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously)~      Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to~     intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of~     one year. QoL after one month after discharge.~   "
81673|NCT01988415|"~     The purpose of this clinical trial is to demonstrate that treatments generated by an~     investigational algorithm reduces spherical aberration compared to currently available~     iDesign treatments.~   "
81674|NCT01988402|"~     Traditional teaching holds that starting allopurinol during an acute gout attack will~     prolong the attack. Recent expert opinion from the American College of Rheumatology~     Guidelines is that allopurinol may be started during an acute, treated gout attack. This~     study is designed to test the hypothesis that allopurinol does not prolong an acute, treated~     gout attack. Patients will either take allopurinol capsules or and identical capsule~     containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack~     that is being treated with other standard measures. During the study, neither the patient~     nor the examiner will know what pills are being taken. The time to resolution of the attack~     is the primary outcome measure. Pain level, serum uric acid level, and complications of~     therapy will also be monitored. A minimum of 32 patients completing the study are needed for~     a meaningful conclusion.~   "
81675|NCT01988389|"~     There is now considerable scientific evidence that a diet rich in fruits and vegetables~     could improve human health. Apples are among the most frequently consumed fruits in the~     world. Epidemiological studies have linked frequent apple consumption with several health~     benefits including a reduced risk of cardiovascular disease. Apples are an important source~     of polyphenols and fiber and their beneficial effects could be attributed to this content;~     however, their impact on our health is not clear. Although, there are some studies that have~     reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies~     have explored the impact on vascular function and gut microbiota. The objective of the~     current study is to assess whether a regular apple consumption, reduces total cholesterol~     levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic~     subjects compared with a control, sugar matched commercial clear apple juice squash.~   "
81676|NCT01988376|"~     Background/Purpose: This is a large scale, multicenter randomized clinical trial to assess~     the feasibility of using SurePath® in cervical cancer patients after radiation therapy by~     comparing the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal~     lesions between the SurePath® and the conventional smear.~      Patients and Methods: The investigators will invite all women who had received radiotherapy~     for cervical cancer in the investigators outpatient clinics. All enrolled cases will ask to~     receive randomly the SurePath® or the conventional smear.~      Expected Results: The investigators will get the incidence of unsatisfactory smear and the~     accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional~     smear in patients who underwent radiotherapy.~   "
81677|NCT01988363|"~     This study is designed to answer the question of whether injection of the greater occipital~     nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective~     in improving pain in human subjects.~      HYPOTHESES~        1. Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a~          novel, proximal C2 location in live, human subjects, measured by improvement in visual~          analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes~          post-injection, 2-weeks post-injection, and 1-month post-injection .~        2. Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2~          location is effective at improvement of both occipital neuralgia and cervicogenic~          headache demonstrated by improvement in visual analog scale (VAS) pain scores~          pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection,~          and 1-month post-injection. We further hypothesize that the mean improvement in VAS~          scores at 1-month post injection will be greater than 2 units.~        3. Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel,~          proximal C2 location in live, human subjects appears safe.~   "
81678|NCT01988350|"~     Pancreatic insufficiency is a condition in which there is a decrease in the production and~     release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many~     chronic diseases that can lead to pancreatic insufficiency. In the early stages of this~     disease, a patient may not experience any symptoms, and the prevalence of pancreatic~     insufficiency may be underestimated. Smoking has long been recognized as a cause of disease~     in many organs in the body. Cigarette smoke causes inflammation and damages tissue,~     including the pancreas. Studies have shown that smoking is an independent risk factor for~     pancreatic cancer and chronic pancreatitis. It has also been shown that the more a person~     smokes, the worse his disease will be. Additionally, there are studies that show that~     smokers have nutritional deficiencies. There are observational and retrospective studies~     that suggest that pancreatic insufficiency may also be caused by smoking. However, this has~     not been established, and the relationship has not been examined in a controlled manner.~     This study examines the relationship between smoking and pancreatic insufficiency in~     patients who do not have other pancreatic diseases.~   "
81680|NCT01988324|"~     Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in~     treatment-decision making. Patients with ER-positive tumors can be treated with~     anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy.~     Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging~     (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast~     cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of~     tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic~     breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular~     imaging of tumor AR- and ER-expression may well be of value for future treatment~     decision-making.~   "
81681|NCT01988311|"~     This is a pilot study to finalize methods for a larger study being planned for the future.~     This research is being done to characterize performance of tasks, brain functioning, and the~     effects of psilocybin in individuals with a long-term meditation practice.~      There are three different parts of the pilot study:~        1. Effects of psilocybin on psychological function: This version of the pilot study will~          involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment~          visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on~          the Johns Hopkins Bayview Campus).~        2. Performance on behavioral and cognitive tasks: This version of the pilot study will~          involve completing various behavioral and cognitive tasks at our research unit. You~          will make a total of about 1-10 visits to our research unit (the BPRU on the Johns~          Hopkins Bayview Campus).~        3. Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI)~          measurements. You will make a total of about 2 to 5 visits to our research unit (the~          BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the~          F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the~          Johns Hopkins Hospital).~      People who are between the ages of 25 and 80 years old, who have a current, regular~     meditation practice, and who meet the medical requirements may join.~   "
81682|NCT01988298|"~     Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity,~     especially in developing countries. Postpartum hypertension can be related to persistence of~     gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could~     develop de novo secondary to other causes. The available data in the medical literature have~     primarily focused on antenatal and peripartum management. There are few data regarding the~     evaluation in women who are diagnosis with postpartum hypertension. Some medications that~     cause vasoconstriction are often used for pain relief, in women having perineal lacerations,~     episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal~     antiinflammatory drugs that are associated with vasoconstriction and sodium and water~     retention, this drugs can result in severe hypertension.~      The purpose of this study is to evaluate maternal postpartum hypertension in women with~     severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.~   "
81683|NCT01988285|"~     Purpose: To validate our previously developed model of risk factors for diagnosis of~     eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in~     diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800~     participants (approximately 400 with EoE and 400 without EoE) who are referred for upper~     endoscopy. Procedures: This is a prospective cohort study. Patients will be compared with~     newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients~     after treatment, and also reassess untreated controls. Data collection will include~     questionnaire results, blood collection, and tissue collection (esophageal biopsies~     performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the~     presence of the candidate biomarkers. Patients will be compared with newly diagnosed EoE to~     non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also~     reassess untreated controls. Data collection will include questionnaire results, blood~     collection, possible saliva collection, possible urine collection, and tissue collection~     (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood~     will be analyzed for the presence of the candidate biomarkers, including eotaxin-3 and~     IL-13.~   "
81684|NCT01988272|"~     The goal of this study is to develop imaging based methods to accurately determine the~     energy absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy~     with I-131 tositumomab . The administration of the radioactive, iodine-131 labeled,~     monoclonal antibody I-131 tositumomab, (also known as Bexxar) is part of the patient's~     clinical treatment protocol. For the absorbed dose measurement, investigators at the~     University of Michigan are evaluating a new Nuclear Medicine SPECT/CT imaging system . This~     new camera combines a CT imaging system in addition to a Nuclear Medicine SPECT scanner. CT~     scans allow the doctors to see a high quality picture of your internal organs. The Nuclear~     Medicine SPECT scanner allows the doctors to see the uptake of the radioactive I-131~     including the tumor sites. The improved imaging using the SPECT/CT enables more accurate~     calculation of the energy absorbed by tumor tissue and bone marrow. Using the results from~     these calculations and clinical follow up data, the researchers will investigate the~     relationship between the absorbed dose to the tumor and the patient's tumor response as well~     as the relationship between the absorbed dose to the bone marrow and the bone marrow~     toxicity. These relationships can potentially be used in the future by doctors to help~     determine how much radioactive I-131 to administer to each patient to get optimal results.~   "
81685|NCT01988259|"~     To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an~     apparatus to examine head-neck-coordination was constructed.~      Two different surgical techniques will be compared:~      Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open~     approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well~     as 3 and 12 month follow-up.~      Hypothesis is that patients after MIS-approaches perform better in their~     head-neck-coordination as patients with open approaches.~   "
81686|NCT01988246|"~     To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in~     patients with diabetic retinopathy in the prevention of macular edema following cataract~     surgery.~   "
81687|NCT01988233|"~     Investigators propose a randomized controlled trial (RCT) to test the efficacy of the~     revised 4-month BAILAMOS© program for improving lifestyle PA and health outcomes (physical~     and cognitive function, self-reported functional limitations, disability) in sedentary older~     Latinos at risk for disability relative to an attention control group.~   "
81688|NCT01988220|"~     Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory~     deficits. Sensory impairments are often overlooked in the therapeutic setting, although they~     lead to slower motor recovery.~      Working hypothesis: The overall goal of this study is to examine the effectiveness of a~     sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke~     patients with sensory impairments. We assume that subjects to both groups will make~     progress, which will be more significant in the experimental group.~      Methods: Study population and design: Sixty individuals with chronic sensory impairment~     following a stroke will be recruited. Patients will be randomly assigned to sensory~     retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45~     minute long intervention sessions, carried out within a 6 weeks period, and a home exercise~     program. The person conducting the assessments will be blind to the treatment allocation of~     the subjects. Outcome measures: The efficacy of the intervention will be determined in~     relation to the International Classification of Functionality (ICF) developed by the World~     Health Organization and will include assessments at the three domains defined by this model:~     1. Body structure and function - determined by measures of the sensory capacity of the lower~     more affected limb; 2. Activities - determined by measures of balance and gait; 3.~     Participation - determined by measures of well-being and social reintegration.~      Two new outcome measures, for ankle and knee position sense and for texture discrimination~     of the foot, will be developed within this study. Data reliability measures on healthy~     population, and test - retest measures in post stroke population with be collected.~      Intervention: The experimental group will be treated by a perception learning oriented~     protocol for sensory reeducation, to improve identification, localization and discrimination~     of sensory stimuli, including electrical stimulation, texture and hardness discrimination~     and position sense training. The control group will receive the same stimuli without the~     attentive learning and discriminating component.~      Importance: Scientific proof and focused recommendations for a potent therapeutic method for~     the post-stroke population, allowing them better participation and quality of life.~      Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.~   "
81689|NCT01988207|"~     The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease~     Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish~     the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic,~     perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on~     individuals who rely on their voices the most—teachers, preachers,salespeople,~     singers—costing them time, money, and even their jobs. It can lead to vocal fatigue, pain,~     and complete loss of voice. While treatments have emerged with some promising effects, no~     treatments have proven to have long-term benefits to all patients. Our preliminary data~     demonstrate Flow Phonation training resulted in significant decreases in Laryngeal~     Resistance to phonatory airflow with associated improvements in voice quality and voice~     handicap ratings. Sample size for our pilot study was small; no control group was utilized;~     and outcome measures were limited. In the proposed investigation, a larger sample will be~     obtained, a control group of participants receiving only Vocal Hygiene Training will be used~     for comparison during the first 3 weeks, and a wider range of outcome measures will be~     included over a longer period of time (1 year).~   "
81690|NCT01988194|"~     Many hospitalized patients experience pain during their hospital stay, and less than half~     report adequate pain relief. Common treatments for pain include opioid medications, which~     have associated side effects and complications. Research has shown that acupuncture is~     effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More~     research is needed on the effectiveness of adding acupuncture to routine care for~     hospitalized patients. The objective of this study is to examine the effectiveness of~     acupuncture delivered in a real-world setting according to the principles of traditional~     Chinese medicine among hospitalized patients to manage pain and other symptoms. 250~     hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual~     care or 2) usual care with acupuncture offered (125 in each group). The primary outcome~     measure will be change in daily pain intensity. Data on other symptoms, such as nausea,~     vomiting, anxiety, and depression, as well as functionality and quality of life will be~     collected in person, on a web-based survey, or via telephone follow-up. The aims of the~     study are to examine the effectiveness of acupuncture to manage pain and other symptoms~     among hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction~     among hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture~     among a subset of hospitalized patients.~      The investigators hypothesize that compared to hospitalized patients receiving usual care~     alone, hospitalized patients receiving acupuncture will have:~        1. decreased pain severity~        2. higher patient satisfaction~   "
81691|NCT01988181|"~     As kidney function declines, the ability to maintain water balance is impaired and is most~     often treated with hemodialysis. The removal of excess water in hemodialysis often leads to~     a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness,~     cramping, and chest pain. This sudden drop in blood pressure has been linked with~     complications of heart attacks, strokes and even death. Research has focused on different~     ways to prevent dangerous drops in blood pressure during hemodialysis. One way is the use of~     blood volume monitoring biofeedback technology to monitor the patient's relative blood~     volume and automatically reduce the amount of fluid that is being removed when the blood~     volume is low to prevent the drop in blood pressure from occurring. This type of biofeedback~     device is currently available on some hemodialysis machines and while this approach~     appealing, it is not clear how effective this form of biofeedback is in preventing the drops~     in blood pressure.~      We plan to determine if the use of biofeedback based on the changes in the patient's blood~     volume will reduce the number of sudden drops in blood pressure that occur during~     hemodialysis. To do this, we will compare patients treated with this technology to current~     hemodialysis practices and follow them for important adverse outcomes. The result of~     interest will be the frequency of hemodialysis sessions complicated by a sudden symptomatic~     drop in blood pressure. We also plan to monitor the amount of water in the different body~     compartments, blood pressure, blood pressure medication use, markers of heart function, and~     patient symptoms and quality of life.~      We hope that by providing information on this technology we can reduce the sudden drops in~     blood pressure in hemodialysis, the associated rates of serious disease or death, and~     improve patient quality of life.~   "
81692|NCT01988168|"~     The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by~     determining the patient recruitment rate and participation rate. The objective of the~     full-scale trial is to determine the optimal method of skin closure after Caesarean delivery~     in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion~     of the placenta, seen typically after rupture of membranes with ascending polymicrobial~     bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of~     Caesarean delivery to skin closure with either staples or sutures. The women will be~     followed at 6 weeks and 6 months post-partum in order to establish the occurrence of~     surgical site infection and wound disruption, as well as evaluation of the scar and other~     secondary questions.~      The investigators hypothesis is that closure of skin with sutures will have a rate of wound~     infection that is no higher than the rate of wound infection when closing skin with staples.~     The investigators also hypothesize that closure with sutures will have a decreased rate of~     wound disruption, increased patient satisfaction and decreased length of hospital stay~     compared to skin closure with staples.~   "
81694|NCT01988142|"~     After spinal cord injury (SCI), the muscular property altered due to the immobilization~     adaptation. The purpose of this study was to investigate the effect of remobilization with~     continuous passive exercise on the adapted paralyzed muscle properties after SCI.~   "
81853|NCT01985997|"~     This is an observational post-marketing study conducted in children and adults immunized~     with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California~     (NCKP) sites.~   "
81695|NCT01988129|"~     Firefighters work some of the most demanding schedules known under highly stressful and~     demanding conditions. The need to work frequent extended shifts and long work weeks leads to~     acute and chronic partial sleep deprivation as well as misalignment of circadian phase.~     Sleep disorders are common, costly, and treatable, but often remain undiagnosed and~     untreated and it is likely that a significant proportion of firefighters suffer from~     undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In~     the current proposal, we aim to address the health, performance and safety issues related to~     fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue~     Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'~   "
81696|NCT01988116|"~     The purpose of the study is to learn more about how treatment with vitamin D can affect iron~     metabolism and blood levels of two hormones that control iron levels, hepcidin and~     hemojuvelin in people with chronic kidney disease (CKD).~      Iron is an essential mineral which is a major component of proteins that carry oxygen in the~     blood. Problems with iron metabolism can lead to low blood levels (anemia), which can~     commonly happen in people with CKD.~      New research over the last decade has uncovered a new hormone called `hepcidin', which is~     made in the liver and released into the blood. Hepcidin controls how much iron is in the~     blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found~     to be high in people with CKD, and a recent small study in people with normal kidney~     function showed that treatment with vitamin D decreased hepcidin levels.~      Another protein, known as `hemojuvelin', has been recently discovered and is also thought to~     control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin~     has never been studied before.~      In this study, investigators would like to examine the effects of vitamin D on iron~     metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.~   "
81697|NCT01988103|"~     This study will test the clinical effectiveness and safety of two orally administered doses~     of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type~     psoriasis.~      Apremilast (CC-10004) is a new oral agent that is under clinical development for the~     treatment of inflammatory autoimmune disorders such as psoriasis, psoriatic arthritis,~     ankylosing spondylitis, rheumatoid arthritis, and Behçet disease.~   "
81698|NCT01988090|"~     This study is being done to look at the difference, if there is a difference between two~     different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is~     caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients.~     The investigators hope to learn if taking a higher dose of Vitamin D is a good way to~     prevent aromatase inhibitor arthralgia (AIA).~   "
81699|NCT01988077|"~     A rationally designed combination of adoptive T cell therapy and ipilimumab could strongly~     increase the proportion of CR patients, as well as the durability of response, as compared~     to ipilimumab or TIL alone. The investigators hypothesize that the combination of those two~     important modalities could result in a durable (≥ 1 year) complete response rate of 30% in~     stage IV melanoma patients.~   "
81700|NCT01988064|"~     The aim of this study is to compare the efficacy of group training using a tutorial film and~     one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in~     the pulse rhythm in patients with cardiovascular diseases.~   "
81701|NCT01988038|"~     The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not~     require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD~     Repository has been designed to include demographic, clinical, biochemical, and genetic data~     that will further explore the natural history of the disorder and assess the factors that~     are likely to be associated with the progression of disease and the incidence of~     complications including renal failure, cardiovascular disease, and stroke.~   "
81702|NCT01988012|"~     This open-label, single-arm study will evaluate the safety and efficacy of RoActemra/Actemra~     alone or concomitant with other antirheumatic drugs when administered as a single, weekly~     injection in patients with rheumatoid arthritis.~   "
81703|NCT01987999|"~     The purpose of this study is to confirm the findings of an early study with prostate cancer~     and to expand our knowledge of treating prostate cancer using an~     Adenosine-5'-triphosphate(ATP)inhibitor.~   "
81704|NCT01987986|"~     To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of~     edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.~   "
81705|NCT01987973|"~     The investigators hypothesize that the use of an allograft adjuvant to partial repair will~     lead to improved shoulder outcome measure scores compared to partial repair alone in massive~     rotator cuff tears.~   "
81706|NCT01987960|"~     To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or~     sertraline on PTSD symptoms.~   "
81707|NCT01987947|"~     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of additional quilizumab therapy in adult patients with~     Chronic Spontaneous Urticaria resistant to antihistamine treatment.~   "
81708|NCT01987934|"~     Oral cancer represents the sixth most common cancer worldwide whilst in Pakistan it ranks~     the second most common cancer in either gender. Histologically, over 90% of oral cancer~     lesions are squamous cell carcinomas which are diagnosed on the basis of histopathological~     analysis. However, proliferation kinetics and nucleolar status are not clearly delineated by~     routine H&E examination; thus making use of various proliferation markers imperative for the~     purpose.~      Nuclear organizer regions (AgNORs) are associated with proliferative activity and represents~     as a diagnostic aid in oral malignancies. Similarly, methyl green pyronin (MGP) stain has~     also been valuable as a complement in routine histopathological studies of several~     neoplastic entities.~      Morphometric techniques offer an opportunity to quantify nuclear changes associated with~     malignancy and may provide an objective basis for grading the tumors. The present study is~     planned to analyze the morphometric parameters of the MGP stain in oral squamous cell~     carcinoma, and in their various histological grades, and to assess if the MGP staining~     parameters could give information on the aggressiveness of the malignant lesions of oral~     cavity.~      Sections from thirty cases of squamous cell carcinoma along with thirty cases of normal oral~     mucosa will be evaluated for methyl green pyronin (MGP) and AgNOR staining. Morphometric~     analysis of various MGP staining and AgNOR parameters would be performed using micrometer.~     Statistical analysis of the results will be carried out using SPSS. Quantitative variables~     will be expressed as mean ± Standard Deviation. Frequencies and percentages will be given~     for qualitative variables.~      It is hypothesized that oral squamous cell carcinoma will exhibit significantly higher MGP~     staining and AgNOR staining parameters than normal mucosa of the oral cavity.~   "
81719|NCT01987739|"~     This was a six-way crossover study with six single-dose treatment sessions. The profile of~     acute effects on abuse potential measures of different almorexant doses was compared to that~     of placebo and two doses of zolpidem~   "
81709|NCT01987921|"~     Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in~     critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI~     in children is limited by single center retrospective data and inconsistent diagnostic and~     stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a~     composite of early injury signs and risk of disease, will predict severe subsequent AKI in~     critically ill children and 2) the incorporation of urinary biomarkers into the renal angina~     scoring system will improve the prediction of the severe injury. The AWARE study is~     conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically~     ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO~     AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national~     registry will create the largest ever repository of information available on AKI in~     children.~   "
81710|NCT01987908|"~     Sickle cell disease (SCD) is a genetic blood disorder characterized by the presence of~     sickle-shaped red blood cells. In the U.S. and the U.K. this occurs primarily in persons of~     African origin. There is only one drug (hydroxyurea) approved to manage SCD, but it is not~     fully efficacious and can produce medically significant side effects. Aes-103 is being~     evaluated as a novel agent for the long term management of SCD. By directly reducing the~     sickling process, Aes-103 has a different mechanism of action than hydoxyurea. The active~     ingredient in Aes-103 is 5-hydroxymethyl furfural, a naturally occurring small molecule that~     is chemically related to glucose.~      This study will evaluate the safety and pharmacokinetic profile of two dosing regimens of~     Aes-103 for up to 28 days in up to 50 adult subjects with stable SCD compared with subjects~     receiving placebo.~   "
81711|NCT01987843|"~     The primary objectives of the study are:~        -  To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects~          with moderate to severe chronic plaque psoriasis.~        -  To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to~          severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on~          Psoriasis Area and Severity Index (PASI).~   "
81712|NCT01987830|"~     This research study is exploring how the blood vessels in the participant's tumor change~     from treatment with bevacizumab, and how these changes affect the way their tumor absorbs~     temozolomide (TMZ).~      The pilot part of this study is to evaluate the use of [11C] temozolomide PET (TMZ-PET)~     scans and MRI scans to tell investigators more about how standard treatment with bevacizumab~     affects the blood vessels in the participant's tumor, and how these changes affect the way~     the participant's tumor absorbs temozolomide. Investigational means that the role of~     TMZ-PET scans is still being studied and that research doctors are trying to find out more~     about it.~      Bevacizumab is approved by the U.S. Food and Drug Administration for use in people with the~     participant's type of cancer. It works by blocking signals on a specific protein called~     vascular endothelial growth hormone (VEGF), which plays a role in promoting the growth of~     spread of tumor blood vessels. Bevacizumab is an anti-VEGF' agent because it is designed to~     slow the growth of the participant's cancer.~      Since anti-VEGF agents also affect normal blood vessels in the brain, they can inhibit the~     way other drugs used in combination with bevacizumab are delivered to the tumor. Researchers~     are looking for how bevacizumab affects delivery of chemotherapy, in this case temozolomide.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells.~      For the PET scans in this research study, the investigators are using a radioactive~     substance called [11C] temozolomide, which is chemically identical to the prescription drug~     TMZ. TMZ is FDA approved as a chemotherapeutic agent in cancer but [11C] temozolomide is an~     investigational agent.~      In this research study, participants will receive standard treatment with bevacizumab and~     oral temozolomide as well as standard MRI scans. In addition, participants will undergo~     TMZ-PET scans before and after treatment with bevacizumab. The first TMZ-PET scan will occur~     7-13 days after starting treatment with oral temozolomide but before beginning treatment~     with bevacizumab, day 1 after starting treatment with bevacizumab and 1 month after starting~     bevacizumab. TMZ-PET scans will be given at the same time as a vascular MRI, which will~     evaluate the changes in tumor blood flow, blood volume, and how receptive blood vessels are~     while also measuring how much TMZ is in the brain.~   "
81713|NCT01987817|"~     This is a multi-center, randomized, double-blind placebo controlled study of efficacy and~     safety of characterized peanut oral immunotherapy in peanut allergic individuals.~   "
81714|NCT01987804|"~     Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a~     consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an~     increased pH, which creates an environment more susceptible to infections . The mucosal~     epithelium shows signs of severe senile atrophy and cytological examination demonstrate~     increased number of the basal and parabasal cells and reduced number of superficial cells .~     Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally~     persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically~     via the posterior pituitary. The most well known effects of oxytocin are its roles in female~     reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to~     exert positive effects on the proliferation of human vaginal mucosal cells from~     postmenopausal women, an effect which could be attributed either to the direct stimulation~     of new cell formation or to an increased production of other growth factors. The primary~     objective is to investigate the dose relationsship of topical administrated Vagitocin on the~     vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after~     baseline.~   "
81715|NCT01987791|"~     To compare the safety and efficacy of 12 months of low dose prednisone with low dose~     cyclosporine combined with entecavir in patients with thrombocytopenia associated with~     HBV-related cirrhosis.~   "
81716|NCT01987778|"~     Today's women will live more than a third of their lives after menopause, i.e. with a~     changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are~     reported by about 75% of all women around menopause and may impair well-being, mental state,~     daily activities and night sleep. Vasomotor symptoms are less prevalent in women who~     participate in regular physical exercise. It is, however, still uncertain if physical~     exercise reduces vasomotor symptoms.~      The purpose of this randomized controlled study is to establish possible beneficial health~     effects from 15 weeks of supervised resistance training (RT) on postmenopausal women.~     End-points include effects from RT in postmenopausal women on~        1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of~          Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass,~          browning of fat),~        2. diagnostic variables (production of myokines as irisin, immunological markers) and~        3. genetic variables (length of telomeres).~      The control group will be offered resistance training after the intervention period.~   "
81717|NCT01987765|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who~     are treated with Relestat as standard of care in clinical practice.~   "
81718|NCT01987752|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients~     with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta~     blockers treated as per standard of care in clinical practice.~   "
81721|NCT01987713|"~     Methods: This study will be a three-year mixed methods study, including the identification~     of obesity issues among children with chronic conditions in the first phase study~     (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study~     (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle~     intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry,~     healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit~     will be conducted. By using the literature review, meta-analysis and focus-research~     approaches to develop a healthy lifestyle intervention protocol in the second year program.~     The protocol will be tested on a sample of school-age children with asthma, to develop a~     school-based and family-involved healthy lifestyle intervention. Finally, the protocol will~     be undertaken on children with asthma aged 10-15, by using an experimental~     (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly~     assign to condition of receiving intervention or control; the measurement of the outcome~     across 4 observations, to assess both group differences (experimental comparison), and~     changes within groups. The interventions consist of healthy diet (X1), regular exercise~     (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from~     baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively.~     Outcome indicators include height, body weight, waist circumference as well as healthy life~     style modification present by diet record, exercise diary, healthy life environments. The~     research subjects will consist of randomly sampled school-age children and their fathers (or~     mothers), school teachers and school nurses. The approximate sample size is estimated by~     power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of~     children with their parents, school teachers and nurses in the first and third year~     respectively.~   "
81722|NCT01987700|"~     The primary objective of this study is to examine and compare the outcomes associated with~     the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine~     acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large~     complicated abdominal wall hernias.~   "
81723|NCT01987687|"~     Postprandial glycaemic control is an important risk factor for the development of type 2~     diabetes, cardiovascular disease and all-cause mortality.~      Previous research has demonstrated that exercise performed in the postprandial state~     paradoxically results in a deterioration in glucose tolerance in the immediate post-exercise~     period (Gonzalez et a. 2013; Gonzalez and Stevenson 2013). This study aims to assess the~     timecourse of this post-exercise effect.~   "
81724|NCT01987674|"~     The purpose of this study is to investigate if a pre-meal drink containing proteins can~     positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison~     with a placebo is included.~   "
81725|NCT01987661|"~     15 COPD patients will be surveyed in this prospective randomized crossover pilot study~     concerning non invasive ventilation. Patients will be treated over 2 nights in randomized~     order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography~     (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by~     evaluating the PSG and pCO2 values over night.~      Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on~     pCO2 values over night.~   "
81726|NCT01987648|"~     Regarding the postoperative care strategies following elective craniotomy procedures there~     is little evidence. Many neurosurgical departments prefer these patients to remain intubated~     and sedated for many hours postoperatively to minimize hemodynamic and respiratory distress~     in fear of early postoperative complications such as rebleeding or seizures. In this~     prospective observational study the investigators aim to show that early tracheal extubation~     following elective brain surgery is feasible and safe.~   "
81727|NCT01987635|"~     Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure~     long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to~     complete flexible ring substitutes, the most recent ones are aimed to restore the natural~     saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral~     leaflets and chordal attachments. So far, even for flexible ring devices, the sustained~     flexibility of the device remained unproven, probably by cicatricial fibrotic tissue~     ingrowth after implantation.~      Due to specific structural characteristics based on a nitinolstent with carbofilm-coating,~     the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the~     cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease~     the stress during the systolo-diastolic movements of the valve, and so, improve the late~     durability of the repair.~      Echocardiography is the first-line technique for mitral valve assessment after surgical~     repair, for both intra-operative evaluation and serial follow-up of valve function.~     Recently, three-dimensional echocardiography has been introduced into clinical practice,~     affording qualitative and quantitative measurement of mitral valve function and size during~     the cardiac cycle.This method allows to quantify precisely the excursion of the mitral~     annulus between systole and diastole.~      The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus~     after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation~     and its sustainability, 1 year after implantation.~      This hypothesis is tested in a case-controlled comparison with a standard used rigid ring~     device.~      Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after~     1 year, to define the size and surface change of the mitral anuloplasty device during the~     cardiac cycle.~      Based on a sample size calculation, 10 patients in each comparison group will be included,~     suggesting a study cohort of 20 patients eligible for mitral valve repair.~   "
81728|NCT01987622|"~     Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the~     beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor~     adverse events. However, little information exists regarding the effects and safety of~     acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that~     present chronic low back and leg pain.~      The investigators aimed to assess the overall effectiveness, safety, and feasibility of~     acupuncture in combination with usual care (as opposed to usual care alone) for patients~     with symptomatic degenerative lumbar spinal stenosis.~      The hypotheses of this study are as follows:~        1. A set of acupuncture sessions in combination with usual care can provide greater~          functional improvements than usual care alone .~        2. A set of acupuncture sessions in combination with usual care can provide greater pain~          reduction than usual care alone .~      The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual~     care group).~   "
81729|NCT01987609|"~     Dendritic cells are a key component of the inflammatory response seen in psoriasis. Several~     current psoriasis therapies have been shown to reduce the number of dendritic cells in~     patients with psoriasis, leading researchers to believe that therapies specifically~     targeting dendritic cells may lead to improvement in psoriasis. Research recently conducted~     in Dr. Gallo's lab at the University of California San Diego has shown that transgenic mice~     overexpressing the enzyme hyaluronidase have a significant decrease in the number of~     dendritic cells in the dermal component of their skin compared to wild type mice. If~     hyaluronidase overexpression in humans also decreases the number of dendritic cells in the~     dermis, then hyaluronidase therapy may improve the clinical presentation of psoriasis. In~     order to test this hypothesis, recombinant human hyaluronidase (Hylenex®) will be injected~     subcutaneously below a psoriatic plaque in human psoriasis patients every week for a total~     of 4 weeks. Each week the clinical appearance of the plaque will be documented. At the final~     visit skin biopsies of the treated plaque will be taken to visualize the histology of the~     plaque and look for changes in expression of different inflammatory markers.~   "
81730|NCT01987596|"~     This randomized phase III trial studies flexible administration of filgrastim after~     combination chemotherapy to see how well it works compared to fixed administration of~     filgrastim in decreasing side effects of chemotherapy in younger patients with cancer.~     Cancer chemotherapy frequently results in neutropenia (low blood counts) when patients are~     susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone~     marrow and daily filgrastim shots are commonly used to shorten neutropenic periods and~     decrease infections after chemotherapy. Since filgrastim is customarily used on a fixed~     schedule starting early after chemotherapy and there are data that early doses may not be~     needed, this study tests new flexible schedule of filgrastim to optimize its use by reducing~     the number of painful shots, cost of treatment, and filgrastim side effects in children with~     cancer receiving chemotherapy.~   "
81731|NCT01987583|"~     This research proposal is submitted to fulfill the requirement of the PHD degree of~     Community Medicine Saudi Board at the Joint Program of Family and Community Medicine in~     Jeddah, Saudi Arabia.~      Background: Cupping is an ancient treatment remedy that has been used for many centuries in~     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular~     treatment because of its religious background. Despite of that, it still has little~     scientific evidence that proves its efficacy. Many hijama healers claim that they have~     observed dramatic improvement in Blood pressure control of hypertension patients. Not many~     studies support that. This study should help to prove or disprove this hypothesis.~      Objectives:~        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure~          patients.~        -  To assess the incidence of wet cupping side effects in the intervention group.~      Methods: The study design is a randomised controlled trial. There will be an intervention~     group of high blood pressure patients who will perform hijama in addition to their usual~     management, and a control group of high blood pressure patients who will receive their usual~     anti-hypertension management only. There will be 8 weeks follow up period. After that, data~     entry, analysis and interpretation will take place.~      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients~   "
81732|NCT01987570|"~     Generating critical levels of power is a prerequisite for performing simple daily~     activities, such as rising from a chair or climbing stairs. For a young healthy person these~     activities can be performed easily, however after a prolonged period of forced inactivity~     (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss~     of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative~     stress. An enzyme involved in the production of free radicals in various experimental~     models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an~     inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle~     mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial~     is to determine the effect of allopurinol administration on the prevention of muscle mass~     loss in immobilized subjects.~      This is a prospective, randomized study in which fifty young male subjects (aged between 25~     and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization~     the patients will be assigned randomly to one of two experimental groups, one treated with~     allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the~     same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization~     period, which will last fifteen days. This medication will be delivered to the patients when~     they agree to participate in the clinical trial. They will be immobilized by posterior knee~     splint, preventing use of that leg.~      We will determine muscle mass loss by performing two magnetic resonances of both legs before~     and after the immobilization period. We will also take two blood samples (before and after~     immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls,~     and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin),~     as well as vitamin D levels.~   "
81733|NCT01987557|"~     Treadmill training has been shown to be beneficial for reducing motor symptoms of~     Parkinson's disease (PD). The mechanisms for the therapeutic effects of treadmill training~     remain unknown. However, specific types of intrinsic feedback generated from muscle spindles~     (detect changes in length of muscle) and golgi tendon organs (detect muscle force) seem to~     be an important factor for achieving the reductions in motor scores. This study will compare~     a treadmill program that generates a high rate of intrinsic feedback to a treadmill program~     focused on generating a high magnitude of intrinsic feedback.~   "
81734|NCT01987544|"~     Home ergometer training combined with online monitoring and regular telephone support could~     prove to be a cost-effective method to improve physical performance and quality of life in~     COPD patients.~      The primary objective of the study is to demonstrate a significantly higher daily workout~     time in patients that are monitored during home ergometer training with telephone support~     compared to conventional home ergometer training. Consequently we expect an increased~     quality of life related to the illness and a decreasing BODE-Index. A post-interventional~     lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.~   "
81735|NCT01987531|"~     The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic~     performance in patients with right ventricular dysfunction after open cardiac chamber~     cardiac surgery.~   "
81736|NCT01987518|"~     French cohorte about polyposis digestive diseases~   "
81737|NCT01987505|"~     This open-label, single-arm, phase IIIb study will evaluate the safety of switching from~     intravenous (IV) to subcutaneous (SC) administration of MabThera/Rituxan during first-line~     treatment for patients with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large~     B-cell lymphoma (DLBCL) who have already received at least one full dose of MabThera/Rituxan~     IV. Patients with FL will be given 1400 mg MabThera/Rituxan SC during induction therapy~     (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles).~     1400 mg SC of MabThera/Rituxan will be given to patients with DLBCL once monthly for 4-7~     cycles. Treatment duration is expected to last up to 7 months for patients with DLBCL and up~     to 32 months for patients with FL.~   "
81738|NCT01987492|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of~     participants to achieve lower daily doses of OCS, among those with severe~     corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed.~     Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in~     a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may~     continue into a 32-week active treatment extension (ATE) period, during which all~     participants will receive lebrikizumab treatment. Following completion of the ATE period,~     participants who have both tolerated and derived benefit from treatment with lebrikizumab~     may continue into a long-term extension (LTE) which will last until 2018. Participants will~     transition to 24 weeks of safety follow-up upon discontinuation of study drug.~   "
81740|NCT01987466|"~     Postresuscitation disease is a constellation of disorders related to whole-body ischemia and~     reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other~     organ. In previous study more than one-third of patients resuscitation from out of hospital~     cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier~     marker compared with serum creatinine.~      Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum~     NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.~      This study was designed to assess serum NGAL level in postresuscitative patients to evaluate~     its relation to hypoxic brain injury severity, and its clinical utility for early detection~     of acute kidney injury in these patients.~   "
81741|NCT01987453|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin~     (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have~     participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve~     sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification~     (LLOQ) 24 weeks after last dose of study drug (SVR24).~   "
81742|NCT01987440|"~     Pelvic examination, an important part of gynecologic oncology patients to help detect~     cancers recurrence or infections.Despite its importance, many women are reluctant and~     anxious about the procedure because of fear, as well as discomfort and pain. The objective~     of this study is to estimate whether using lubricating gel decreases patient pain during~     speculum insertion compared with using water in gynecologic oncology patients~   "
81743|NCT01987427|"~     APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of~     12-week duration in overweight and obese adults. Approximately 225 subjects will be~     randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations~     of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15~     mg once daily (QD), or lorcaserin alone.~   "
81744|NCT01987414|"~     The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined~     with the occupational therapy task-oriented approach on functional performance for persons~     with a hemiparetic arm.~      Hypotheses of this study are:~        1. participants who wear the forearm rotation orthosis will demonstrate significantly~          greater improvement in functional performance and active range of motion of forearm~          rotators compared to those who do not;~        2. all participants who receive the occupational therapy task-oriented approach~          intervention will demonstrate significant improvement in functional performance; and~        3. all participants who receive the occupational therapy task-oriented approach~          intervention will demonstrate improvement in motor function of the upper extremity.~   "
81745|NCT01987401|"~     The primary objective of CSP #595, Service and Health During the Iraq and Afghanistan Era,~     is to characterize the impact of deployment to Iraq and Afghanistan on the respiratory~     health of Veterans. The purpose of the pilot study is to determine the willingness of~     Veterans who served during the Iraq and Afghanistan Era to provide health and military~     service information. This information will help us design a larger national study.~   "
81746|NCT01987388|"~     The objective is to develop a new metabolic flexibility biomarker, which has application in~     the study of changes diet and exercise on fuel management in humans. The new biomarker~     involves the characterization of an individual's metabolic flexibility utilizing room~     calorimeters rather than the current method, which is based on glucose clamp data. It is~     hypothesized that this new metabolic flexibility method will be a useful and noninvasive~     biomarker for measuring adaptation to exercise and diet challenges.~   "
81747|NCT01987375|"~     This study is an open label, single institution, Phase 1 dose-escalation study to determine~     the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell~     carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a~     dose of an approved head and neck cancer drug (Cetuximab) along with an investigational~     study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to~     surgery that attaches to cancer cells and appears to make them visible to the doctor when he~     uses a special camera during the operation. The investigators are evaluating whether or not~     the use of the study drug along with the special camera will better identify the cancer~     while patients are in the operating room.~   "
81748|NCT01987362|"~     TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain~     inhibitor. This study is designed to characterize the safety, tolerability, pharmacokinetics~     and anti-tumor activity of TEN-010 in patients who are refractory or intolerant to~     standard/approved therapies. This first-in-human study of TEN-010 will be conducted in two~     parts: dose escalation and dose expansion. For dose escalation (Part A), a standard 3+3~     design will be used in which successive cohorts of three or more patients with advanced~     solid tumor malignancies will be treated at escalating doses until a maximum tolerated dose~     (MTD) is identified. For the dose expansion part of the study (Part B), a subset of patients~     with advanced solid malignancies will be treated with TEN-010 at the MTD (or the highest~     dose tested if the MTD is not defined) to further characterize safety and biological effect.~     In addition, up to 10 patients with nuclear protein in testis (NUT) midline carcinoma (NMC)~     will be permitted to enroll in a substudy of the protocol. This is a Phase 1 non-randomized,~     dose-escalating, open label, multi-center study to be conducted in two parts (Part A and~     Part B). A maximum of 56 patients aged 18 years or older with histologically confirmed~     advanced solid tumors with progressive disease requiring therapy will be enrolled in the~     study. It is expected that approximately 36 patients will be enrolled in 6 cohorts of up to~     6 patients per cohort in Part A of the study and 20 additional patients will be enrolled in~     Part B of the study. Up to 10 patients with NMC may be enrolled as part of a substudy within~     the protocol.~   "
81749|NCT01987349|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health. This goal is analogous to what has been achieved in cardiovascular~     medicine where the levels of different forms of cholesterol have provided useful benchmarks~     for cardiovascular health. In this context, immunization with FDA approved flu vaccines~     represents a safe and accessible opportunity to gauge the immune response in a particular~     individual as a function of age and genetics and then to try to find predictive biomarkers.~   "
81750|NCT01987336|"~     To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A~     30cc urine sample would also be collected from the same subject, and analyzed.~   "
81751|NCT01987323|"~     Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of~     latanoprost in treating glaucoma.~      Hypothesis: The investigators have already evaluated carrier stability, drug partitioning,~     in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes~     upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the~     investigators hypothesize that this would be safe and efficacious in humans as well.~      Methodology: A pilot study to assess a liposome formulation containing latanoprost. The~     investigators will recruit 6 study subjects with eyes that have raised IOP, for~     subconjunctival injection of this liposome formulation. The recruited eye will be injected~     and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the~     eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.~      Importance: If proven safe, this method of drug delivery could potentially be used for~     treatment of raised intraocular pressures in blinding conditions such as glaucoma.~   "
81752|NCT01987310|"~     The aim of the current study is to evaluate the association of fatty liver severity and~     endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the~     impact of statin treatment compared to usual care or life style modification on endothelial~     function, liver steatosis and fibrosis.~   "
81753|NCT01987297|"~     In this prospective randomized study for patients with newly diagnosed acute promyelocytic~     leukemia, patients will be randomized into two groups which received retinoic acid and~     arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.~   "
81754|NCT01987284|"~     Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly~     people. Much attention has recently been drawn to the strong relationship between the~     systolic blood pressure and cardiovascular morbidity.~      In previous clinical studies carried out in individuals with normal blood pressure at~     baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the~     effect on systolic blood pressure in hypertensive patients will be larger or equal to the~     fall seen in normotensive patients.~   "
81755|NCT01987271|"~     The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in~     functional capacity of children and adolescents with cystic fibrosis.~   "
81756|NCT01987258|"~     Four months of interval walking training (IWT) is superior to energy-expenditure matched~     continuous walking training (CWT) with regards to weight loss and improvements in glycemic~     control. The reason for this is unclear. One potential explanation for the differential~     outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined~     as the elevated oxygen consumption measured during the hours following an exercise bout. A~     large EPOC means greater energy expenditure which, if energy intake does not change, leads~     to a greater weight loss. This weight loss may subsequently improve glycemic control~        -  Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on~          glycemic control in type 2 diabetics and to assess mechanisms responsible for~          differences (if any). It is hypothesised that IWT will be more advantageous for~          improving glycemic control.~        -  Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC.~          It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.~   "
81757|NCT01987245|"~     Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early~     cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation~     (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early~     identification ROSC is very important. Now there is no an easy, non-invasive and real-time~     method to monitor the quality of CPR. In this study the investigators hypothesis the pulse~     oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR~     to the physicians.~   "
81758|NCT01987232|"~     The purpose of this study is to determine the maximum tolerated dose and assess the safety,~     tolerability and activity of carfilzomib given in combination with carboplatin and etoposide~     as initial therapy for subjects with Extensive-Stage Small-Cell Lung Cancer (ES SCLC).~   "
81759|NCT01987219|"~     Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is~     to determine whether, in patients with familial dysautonomia (FD), there is a component of~     airway obstruction that is reversible. To this end, we will evaluate airway resistance~     before and after receiving the anti-cholinergic ipratropium (Atrovent ®) and the~     beta-2-agonist albuterol (ProVentil®/Ventolin®). We predict that the response to either drug~     will depend on the underlying level of sympathetic and parasympathetic activity and airway~     tone. We will then determine the cardiovascular effects of inhaled ipratropium and albuterol~     in patients with FD. Because patients with FD have fewer sympathetic neurons and denervation~     supersenstivity, we predict that following albuterol inhalation, there will be non-selective~     activation of alpha-1-adrenergic receptors. Furthermore, because of a congenital defect in~     the afferent baroreceptor neurons that sense blood pressure, we suspect that the resulting~     vasoconstriction will be unopposed leading to a pressor effect. We hypothesize that~     inhalation of the anti-cholinergic ipratopium will produce little rise in heart rate, due to~     the extent of parasympathetic denervation to the heart.~   "
81760|NCT01987206|"~     The goal of this proposed study is to explore the feasibility of using a PID~     (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control)~     controller algorithm in an artificial pancreas system, all other components and study design~     being equal.~      The study consists of an evaluation of either type of control algorithm as a part of the~     Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a~     clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA) separated by a~     minimum of 5 days and a maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals~     (dinner and breakfast of 65g and 50g CHO respectively) preceded with a dose of rapid-acting~     insulin equivalent to 100% bolus based on each subject's Insulin to Carbohydrate (I:C) ratio~     and 1 unannounced meal (lunch of 65g carbohydrates, same meal content as dinner); complete~     night from 12:00 am to 7:00 am. The goal is to demonstrate that the AP device is able to~     maintain the subject blood glucose within a safe range at all times.~   "
81761|NCT01987193|"~     The purpose of this study is the development of noninvasive (having no direct contact)~     detector and electronic system that will directly measure tumor blood flow rate.~   "
88696|NCT01896310|"~     The aim of the present study was to propose a new pCLE classification of gastric pit~     patterns and vessel architecture, and to assess the accuracy and interobserver agreement of~     this new pCLE classification system in the stomach.~   "
81762|NCT01987180|"~     The goal of this research is to develop and pilot the NICU-2-Home service, a health~     information technology (IT) concept centered on a smart phone app. NICU-2-Home will provide~     support to parents of very low birth weight (VLBW) infants as they transition from the NICU~     to their homes and eventually establish a medical home with the infant's pediatrician. Once~     the app is developed, we will conduct a feasibility study with randomization to pilot test~     the ability of NICU-2-Home app to (a) improve parent's self-efficacy and confidence in~     caring for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with~     their VLBW infants compared to controls.~   "
81763|NCT01987167|"~     The goal of the study is to determine the earliest structural changes in the optic nerve~     during the acute event and during the twelve months of recovery following Acthar treatment.~   "
81764|NCT01987154|"~     To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed~     protein source for routine nutrition.~   "
81765|NCT01987141|"~     Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM)~     recommended weight gain. To date, there are no randomized controlled trials studying the use~     of the electronic medical record to alert providers to initiate the counseling of patients~     on the IOM gestational weight gain recommendations.~      In the investigator's planned study intervention, using the EPIC EMR system, an electronic~     alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This~     alert will remind providers to counsel patients on the recommendations for gestational~     weight gain. The control group will receive standard prenatal care, without electronic~     alerts generated regarding BMI and gestational weight gain.~      The investigators hypothesize that a higher percentage of patients who receive the~     intervention will meet the IOM guidelines for weight gain.~   "
81766|NCT01987128|"~     Aim of this study is to demonstrate the advantages of intraneural injection over extraneural~     injection in terms of onset and duration on peripheral block. In addition we will evaluate~     the frequency of possible adverse effects.~   "
81767|NCT01987115|"~     Trigger finger is a relatively common disorder affecting the hand. There is limited evidence~     on the efficiency of traditional physiotherapy in treating this condition. Fascial~     manipulation is a gaining momentum manual therapy method. To our knowledge the efficiency of~     fascial manipulation techniques in the treatment of trigger finger was not reported. The~     purpose of this study is to investigate the efficiency of the technique and to compare it~     with the traditional physiotherapy treatment.~   "
81768|NCT01987102|"~     An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the [6R]~     5,10-methylenetetrahydrofolate Dose with Most Favorable Safety Prospect and Confirmed~     Ability to Mitigate High-Dose Methotrexate Induced Toxicity during Treatment of Osteosarcoma~     Patients~   "
81769|NCT01987089|"~     Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been~     associated with anxiety and depressive symptoms, as well as an increased risk of relapse~     back to the drinking.~      Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the~     recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I~     may be efficacious for insomnia during recovery.~      The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a~     post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if~     an improvement in the insomnia is associated with an improvement in the underling alcoholism~     and the daytime functioning. On an exploratory basis, the association of a first-degree~     family history of alcoholism with the insomnia severity and treatment response will also be~     evaluated.~   "
81770|NCT01987076|"~     Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe~     multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake.~     DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral~     and biological disturbances. Its prognosis is directly linked to severity of visceral~     involvement, with a mortality evaluated above 10%.~      Considering curative treatment, there is no consensus. Until now, no controlled trial has~     been performed. Systemic steroids are mainly used in first intention, in particular for~     management of visceral involvements, whatever their severity. From clinical practice,~     topical steroids are often used and could be helpful in the therapeutic management of DRESS.~      We propose to evaluate systemic steroids versus very potent topical steroids in a~     multicentric randomized controlled trial including defined moderate DRESS, ie the~     non-inferiority of very potent topical steroids in terms of remission of visceral~     involvement at Day30 and the superiority of very potent topical steroids in terms of delay~     to remission of skin involvement.~   "
81771|NCT01987063|"~     The purpose of this study is to determine the best obstetrical practices for twin delivery.~   "
81772|NCT01987050|"~     The proposed study is a randomized, double-blind, placebo-controlled study of the value of~     adjunctive intranasal oxytocin added to existing antipsychotic treatment compared with~     adjunctive placebo in subjects with schizophrenia. Enrolled subjects will receive 6 weeks of~     treatment with one of the following adjunctive to a stable antipsychotic regimen: 1) 84~     International Units (IU)/day intranasal oxytocin (42 IU twice a day) 2) 168 IU/day~     intranasal oxytocin (84 IU twice a day) or 3) intranasal placebo. The study will be~     conducted over 2 years. Approximately eighty subjects will be entered into the study. We~     hypothesize that augmentation of antipsychotics with intranasal oxytocin will significantly~     improve psychopathology ratings as compared to placebo and an improvement in certain~     cognitive functions may also be observed.~   "
81773|NCT01987037|"~     The aim of the study is to describe the feasibility of the passation of the assessment~     battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a~     diagnosis of autism spectrum disorder: number and type of evaluable events, number and type~     of tests with a deficit compared to the standard results.~   "
81883|NCT01985607|"~     Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting~     are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive~     hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and~     Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and~     Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of~     distressed infants with reflux, suspected of CMA. One of the preferred proposed options is~     to thicken an extensive hydrolysate .~      This study aims at evaluating the additional value of a thickened extensive hydrolysate in~     children suspected of CMA and presenting with frequent regurgitation.~   "
81774|NCT01987024|"~     It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the~     total duration of hospitalization for patients with a risk of preterm labor before 32 weeks~     of gestation without increasing the number of preterm labour.~      Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/-~     described or recorded uterine contractions) before 32 weeks of gestation will be~     hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to~     our gold standard protocol. After 48 hours, they will be assessed by examination, external~     tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will~     be included and randomized into 2 groups of 210 patients each. The first group A will~     benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the~     clinical and ultrasound assessment); whereas the second group, B, will have the benefit of~     the detection of phIGFBP-1.If the result proves negative, patients could be discharged early~     at day 2. In the case of a positive result, patients will follow the standard procedure~     because of the low positive predictive value of the test. The main outcome is the total~     duration of hospitalization.~      Study duration The trial period will be 36 months.~      Expected results The use of detection of IGFBP-1 would enable us to select patients at risk~     and to decrease the duration of hospitalization in the case of a negative result.~      Perspectives The negative predictive value of phIGFBP-1 test could be useful to select~     patients with stabilized risk of preterm labor, who could be discharged early. Moreover it~     could be used, in the Perinat Sud network, to decide if patients with a risk of preterm~     labor would benefit from hospitalization in a level II or III maternity ward.~   "
81775|NCT01987011|"~     The purpose of this study is to evaluate the immunogenicity and safety of the~     investigational vaccine in the subjects during their participation in the study.~   "
81776|NCT01986998|"~     The investigators plan to carry out a multicenter randomized clinical trial and MRI study of~     high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and~     demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in~     acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this~     therapeutic regimen because it is safer for the patient (less adverse effects) and less~     costly to the healthcare system.~   "
81777|NCT01986985|"~     The objective of this study is to gather image and associated data to of a pre-market~     PET/MRI scanner and to use the data for regulatory submission and future product development~     and marketing. Clinical data is required in order to test the MR attenuation correction of~     PET data. These aims can only be accomplished through a clinical study.~   "
81778|NCT01986972|"~     Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by~     brushing with and without conventional toothpaste. Settings and Design: Twenty-four students~     aged 17 to 28 years old participated in this randomized clinical trial.~      Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group~     (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of~     cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and~     after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were~     performed by paired sample t test.~   "
81779|NCT01986959|"~     Background: There is controversy regarding the postoperative effects of periodontal dressing~     on the periodontium, pain and discomfort. The aim of the present study was to compare~     postoperative pain following surgical crown lengthening with and without the use of~     periodontal dressing.~      Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients.~     Following surgical crown lengthening, the individuals were randomly allocated to the~     periodontal dressing group (PDG) and control group (CG - non-placement of periodontal~     dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale~     (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative~     infection, stability of the gingival margin and type of healing were also evaluated.~   "
81780|NCT01986946|"~     1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar~          Spinal Fusion: A Prospective Randomized Study~        2. Purpose of the Study - This prospective randomized study will enroll 200 patients~          undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary~          objective is to determine the effect of epidural analgesia, as compared with standard~          care, on post-operative analgesia.~      Hypothesis:~      The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with~     epidural catheter placement will have superior post-operative analgesia compared to patients~     undergoing standard care.~   "
81781|NCT01986933|"~     To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic~     dermatitis patients who are inadequately controlled by or intolerant to topical therapy~   "
81782|NCT01986920|"~     Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on~     the back of subjects.~   "
81783|NCT01986907|"~     The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients~     affected by wet age related macular degeneration (wAMD).~   "
81784|NCT01986894|"~     This is a single-center, randomized, double-blind crossover study with four treatments, four~     periods and four sequences to investigate the effects of orally administered pomalidomide on~     QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically~     indicated dose for multiple myeloma [MM] as per the United States Package Insert [USPI] of 4~     mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded.~     Moxifloxacin (positive control) will be administered in an open-label fashion to determine~     the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers~     will be blinded to all study treatments and sequences.~   "
81785|NCT01986881|"~     A study of the cardiovascular outcomes following treatment with ertugliflozin in~     participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main~     objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial~     includes a pre-defined glycemic sub-study in participants receiving background insulin with~     or without metformin, a pre-defined glycemic sub-study in participants receiving background~     sulfonylurea monotherapy, and a pre-defined sub-study in participants receiving background~     metformin with sulfonylurea (all fully-enrolled).~   "
81884|NCT01985594|"~     RESEARCH HYPOTHESIS~      -Incidence of preterm delivery is lower in women treated with oral micronized progesterone~     (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side~     effect~   "
81787|NCT01986855|"~     This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in~     participants with type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who~     have inadequate glycemic control on background antihyperglycemic therapy. The duration of~     this trial will be up to 67 weeks. This will consist of a 1-week Screening Period, a 10-week~     wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week~     double-blind treatment period, and a 14-day post-treatment follow-up period. The primary~     objective of this trial is to assess the A1C-lowering efficacy of the addition of~     ertugliflozin compared to the addition of placebo with an underlying hypothesis that~     addition of treatment with ertugliflozin provides greater reduction in A1C compared to the~     addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of~     ertugliflozin.~   "
81788|NCT01986842|"~     Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining~     skeletal muscle mass with aging, it is important to optimize the adaptive response to food~     intake. However, a paucity of information is available describing the effects of habitual~     dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a~     regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An~     adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle~     adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle~     protein synthesis after protein ingestion.~      The aim of this study is to investigate the effect of a habitual (14 days) high protein diet~     when compared with low protein diet on digestion and absorption kinetics and the subsequent~     muscle protein synthetic response to dietary protein ingestion.~   "
81789|NCT01986829|"~     This phase II trial studies how well cryoablation, radiofrequency ablation, or microwave~     ablation works in treating patients with metastatic sarcoma stable on chemotherapy.~     Cryoablation kills tumor cells by freezing them. Radiofrequency ablation uses a~     high-frequency, electric current to kill tumor cells. Microwave ablation kills tumor cells~     by heating them to several degrees above body temperature.~   "
81790|NCT01986816|"~     The purpose of this study is to investigate the cost of treatment and adverse efffects~     therof corresponds to quality of life improvements and expected wheightloss.~   "
81791|NCT01986803|"~     This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority,~     European multicenter clinical trial.~      The primary objective of this study is to assess the neointimal healing score (as evaluated~     by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and~     treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS)~     at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore,~     the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.~      It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully~     bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic~     drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the~     arterial healing process and potentially reduce late stent thrombosis in patients presenting~     with STEMI.~      This is a preparatory trial in anticipation of a major outcome study.~   "
81792|NCT01986790|"~     The overall goal of the study is to better understand how communication strategies can help~     people make decisions about health insurance plans.~      This study aims to:~        -  (Aim 1) Examine currently uninsured individuals' understanding of terminology and~          details of health insurance plans;~        -  (Aim 2) Apply three recommended strategies for communicating information about health~          insurance plans;~        -  (Aim 3) Test the effects of these strategies in a randomized experiment.~   "
81793|NCT01986777|"~     This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive~     function and EF in 20 postmenopausal women who report onset of cognitive difficulties after~     oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is~     included at critical time points to obtain objective data regarding effects of LDX as well~     as potential predictors of resilience in the face of oophorectomy.~   "
81794|NCT01986764|"~     This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of~     riskreducing bilateral salpingo-oophorectomy (RRSO) with or without post-procedure~     chemotherapy and adjunctive treatments. RRSO after completion of childbearing is recommended~     for prevention of ovarian and breast cancer in women with BRCA1/BRCA2 mutations and standard~     of care for women with some forms of hormone-responsive cancer. Knowledge regarding the~     impact of this procedure, with or without chemotherapy, and subsequent hypogonadism on brain~     health is less than adequate. Premenopausal women who undergo an acute surgical menopause~     are at greater risk for verbal memory decline and executive function (EF) complaints, but as~     of yet, we cannot predict who is going to experience these adverse sequelae, nor do we have~     targeted prevention or treatment strategies other than hormone therapy, which is not an~     option in many cases and not always effective. An idealized sample as women who are planning~     for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as~     well as pre-/post-treatment with E2 or the psychostimulant, lisdexamphetamine (LDX;~     Vyvanse®).~   "
81795|NCT01986751|"~     Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking~     you to take part in a research study. This research study will test whether adding a~     medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last~     less than a day after surgery. We are looking for ways to make them work better and last~     longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks~     is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve~     blocks may also decrease the amount of pain medicine a person has after surgery. All people~     who enter this study will receive a nerve block with the normal medicine, but half of people~     will also have clonidine added to their nerve block. This study will enroll 60 participants~     from UAB hospitals.~   "
81796|NCT01986738|"~     This is a study to assess the motion of pancreatic tumors during radiation therapy using~     Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.~   "
81901|NCT01985373|"~     Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune~     related disorders both as immune-replacement and immune-modulating therapy. Sanquin~     developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion~     with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam~     100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml~     product of Sanquin.~   "
81797|NCT01986725|"~     In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom~     distress and complications, which have an impact on a woman's quality of life and contribute~     to high health care costs. For the majority of the patients, symptom and distress can be~     reduced if adequate treatment is provided. This study aims to test possible differences~     between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence~     in women with vulvar neoplasia after surgical treatment.~      In a sequential explanatory mixed-methods project, a randomized phase II study will be~     followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated~     surgically will participate in the randomized trial in four Swiss hospitals and one Austrian~     hospital. After stratification by precancer/cancer, women will be randomly assigned (1:2~     ratio) to standardized care and the WOMAN-PRO II program. The standardized care group will~     receive a set of information leaflets about supportive care options in the clinic. The~     WOMAN-PRO II program group will obtain counseling sessions by specially trained~     gynecology-oncology nurse specialists at the moment of diagnosis, 7 days post-surgery, in~     week two after discharge, week twelve and week 24 after surgery. The primary outcome of this~     study is symptom prevalence. Secondary outcomes will be collected for explorative reasons~     and include symptom distress, uncertainty, quality of life, social support, resilience,~     quality of care, sociodemographic and medical characteristics, post-surgical complications,~     functional status, cost evaluation and process outcomes. Quantitative data will be collected~     at the counseling points of time and analyzed by using mixed linear regression analysis.~     Twenty interviews will be conducted with women of the WOMAN-PRO II program group. A~     focus-group interview will be conducted with twelve gynecology-oncology nurse specialists in~     order to better understand to which degree the interventions meet individual needs as well~     as to identify remaining barriers and enablers for the implementation of symptom~     self-management. Qualitative data will be analyzed by using thematic analysis and a critical~     hermeneutic reflection.~      This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence,~     patient-reported outcomes and clinical parameters, and inform the design of a possible phase~     III study on the clinical efficacy of the program.~   "
81798|NCT01986712|"~     To evaluate the compliance with and perceptions of treatment, as well as health-related~     quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN~     therapy.~   "
81799|NCT01986699|"~     Study Objective: To compare the hospital costs between the standard surgical procedure and~     the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with~     advanced polyps in the colon.~   "
81800|NCT01986686|"~     Patients will agree to be randomized to either surgery or non-operative management following~     a first episode of Hinchey II diverticulitis. Information will also be collected on rates of~     recurrence rates and major complications in both groups.~   "
81801|NCT01986673|"~     The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is~     absorbed and eliminated by the body, with and without the use of a condom, compared to a~     single oral sildenafil dose and to evaluate the safety of sildenafil cream.~   "
81802|NCT01986660|"~     The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and~     eliminated by the body under defined maximum dosing conditions and to evaluate the safety~     under these conditions.~   "
81803|NCT01986647|"~     Community-dwelling older adults fear loss of independence and nursing home placement more~     than death. Walking difficulty often leads to loss of independence. Exercise is beneficial~     to physical and mental health and may prevent walking difficulty and promote independence.~     Recognizing the importance of exercise, senior housing facilities offer exercise programs to~     their residents. The exercise programs are often group-based, seated range of motion~     exercises that do not challenge the older adult; consequently participation rates and~     resident satisfaction are low.~      If the goal is to improve walking to promote independence than the exercise program should~     specifically target walking. Therefore, we developed a challenging, group exercise program~     entitled On the Move which focuses on the fundamentals of walking. In this research study~     we will determine if the On the Move program is better than a standard program at improving~     walking and promoting independence and if the same benefits can be obtained if the On the~     Move program is delivered by staff of the senior living facilities instead of an exercise~     leader. To answer these questions, 400 community-dwelling older adults living in 32~     different Independent Living Facilities and Senior High Rises or living in the community and~     attending senior community centers will be randomly assigned to either the 12 week On the~     Move group exercise program or the standard group exercise program delivered by either an~     exercise leader or staff activity personnel. Participants' walking and reported ability to~     carry out everyday activities (functional ability) will be assessed before and after the 12~     week program. We will also assess participant safety and satisfaction with the exercise~     program and instructor.~      The findings from this research study will provide evidence for the value of the On the Move~     group exercise program and will better inform patient choices regarding participation in~     exercise programs. If successful in improving walking and promoting independence and~     acceptable to the older adult, the On the Move program could be incorporated into exercise~     programming for older adults in community centers, health clubs, and senior residences~     across the country.~   "
81804|NCT01986634|"~     Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be~     addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable~     scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing,~     usually with laser treatment. Often the peri-oral area is treated with additional spot~     treatments with an ablative laser to cause a more robust healing response and better~     aesthtic result. To date, no studies have specifically shown efficacy of additional spot~     treatment over full facial laser alone.~      This study is designed as a split-face study, to compare the aesthetic results of full field~     laser resurfacing on one half of the face with that of spot treatment of perioral rhytides~     on the other half.~      To clarify further to the IRB board, this is not an experimental treatment. Spot treatment~     is used by many surgeons/laser proceduralists for addressing specific areas of the face.~     This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic~     and enviromental factors that can effect the results the best design for the study to is~     have each patient serve as their own control with a split-face study.~   "
81805|NCT01986621|"~     This pilot study aims to identify patients at moderate to high risk for peri-procedural~     (type 4) myocardial infarction or injury after after undergoing an elective coronary~     intervention (PCI) as measured by high sensitivity troponin T, who might benefit from more~     potent antiplatelet therapy.~   "
81806|NCT01986608|"~     This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a~     single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral~     dose of LCM 200 mg in healthy Japanese subjects.~   "
81807|NCT01986595|"~     Neuroblastoma (NB) originates from the sympathetic nervous system and is one of the most~     common cancers in infants and children. In our hospital, nearly 70% of patients are~     diagnosed with stage 4, metastatic disease with a poor prognosis, despite the use of~     multimodal therapy including chemotherapy, surgery, autologous stem cell transplantation,~     radiation therapy, and differentiation therapy. To improve the survival rate and patient~     care, our NB Study Group has devoted to the research on NB-specific molecular imaging,~     biomarkers, and target therapy. We have confirmed studies in cancer genetics by showing that~     N-myc gene (MYCN) amplification and segmental abnormalities on overall genomic profiling~     both have an adverse effect on treatment outcome. Therefore, there is an unmet need for the~     development of novel molecular target therapy in NB. Recently, the anaplastic lymphoma~     kinase (ALK) oncogene has been found to play an important role in the pathogenesis of NB, as~     well as serving as the driver mutations in approximately 10% of high-risk NB. The~     availability of ALK inhibitors also enables ALK as a treatment target in NB. In this~     proposal, we plan to utilize gene sequencing, array-comparative hybridization, and multiplex~     ligation-dependent probe amplification methods to evaluate the frequencies and~     characteristics of ALK mutations and amplifications in patients with NB. The gene and~     protein expression of ALK will also be evaluated by quantitative polymerase chain~     reaction(PCR) and immunohistochemistry, respectively, and compared with ALK genotype. The~     overall genomic pattern, clinical characteristics, histopathology, and treatment outcome of~     ALK-mutated NB patients will be analyzed. The results from this study may serve as the first~     report on ALK mutations of NB in Taiwan and will be used for the development of standardized~     genetic diagnosis protocols, as well as the design of future clinical trials targeting ALK.~   "
81808|NCT01986582|"~     Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The~     effectiveness of the intranasally applied formulations is diminished by the cleaning~     mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal~     mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would~     improve their efficacy. One method is creating dosage forms containing mucoadhesive~     polymers. We have demonstrated that a mucoadhesive solution containing HPMC enhances the~     clinical efficacy of oxymetazoline. However, the industrial development of fixed~     combinations of pharmaceutical compound and mucoadhesive carrier requires substantial~     investments, escalating manifold if different pharmaceutical compounds have to be rendered~     mucoadhesive.~      NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal~     surface of the nose blocking the contact of the pollen grains with the nasal mucosa in~     seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl~     (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the~     formation of a gel layer can substantially delay their clearance from the nose and thus~     increase their effectiveness. This hypothesis needs to be substantiated clinically.~   "
81809|NCT01986569|"~     The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and~     determination of tumor estrogen status according to National Comprehensive Cancer Network~     and European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most~     commonly used method for determining ER status. A investigational imaging tracer named~     16-alpha-[18F]-fluoro-17-beta-estradiol, or [18F]fluoroestradiol ([18F]FES) acts similarly~     in vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have~     shown the efficacy of [18F]FES PET in detecting ER positive breast cancer without any~     observed toxicity. The investigators hypothesized that [18F]FES PET imaging can~     noninvasively assess ER status in recurrent or metastatic breast cancer lesion . In this~     study, a positive and negative percent agreement between IHC and [18F]FES will be~     determined.~   "
81810|NCT01986556|"~     This study will assess the relative bioavailability of lesinurad tablets, manufactured at~     two different sites.~   "
81811|NCT01986543|"~     We propose a first interaction study between efavirenz (EFV) and R20mg/Kg taking into~     consideration the absence of data about R induction at this dose. Due to an important~     inter-patient variability of the CYP2B6 polymorphism, the EFV pharmacokinetic (Pk) will be~     compared in same patients with and without TB treatment.~      The main objective is to compare the Pk parameters of EFV in HIV-TB co-infected patients,~     with and without TB treatment, using R at 10 and 20mg/Kg/day and EFV at 600 and 800mg/day.~   "
81812|NCT01986530|"~     Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating~     adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the~     role of circulating irisin in healthy individuals in correlation with lean and fat body~     mass. Furthermore, the circadian and seasonal variation of irisin is largely unknown.~   "
81813|NCT01986517|"~     The purpose of the current study is to examine the influence of feedback on~     psychotherapeutic competency. The present randomized controlled study compares a feedback~     condition with a non-feedback condition. Therapists in the feedback condition receive~     feedback after every fourth session. The feedback is given by two trained and independent~     raters. The raters are licenced and experienced psychotherapists. Therapists in the~     non-feedback condition receive no feedback during the psychotherapy.~   "
81814|NCT01986504|"~     The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective~     identification and collection of data of infectious disease complications in order to~     determine the epidemiology, risk factors, and outcomes of patients who receive solid organ~     or stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers.~     It is essential for the care and treatment of this population to employ a mechanism for~     investigators to centralize these datasets, using standardized definitions of infectious~     complications. This protocol outlines the procedures to be utilized in order to~     prospectively follow the diagnosis and treatment of infectious complications in transplant~     patients.~   "
81815|NCT01986491|"~     The purpose of the study is to compare the pharmacokinetics (what a medication does to the~     body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose~     oral administration of two solid oral formulations in Part 1; based on the profile in Part~     1, one of the formulations assessed will be selected to investigate the pharmacokinetics in~     fasting condition in Part 2 and after repeated dosing in Part 3.~   "
81816|NCT01986478|"~     To collect data for a reference database.~   "
81817|NCT01986465|"~     The aim of this study is to evaluate the effectiveness of steroid injection and~     immobilization versus no immobilization in treating patients with lateral epicondylitis.~   "
81818|NCT01986452|"~     Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor~     acceptance and adherence. There is a great potential to significantly improve the treatment~     and care of these patients in a time economic way by telemonitoring the therapy in home~     environment.~      This study is planned to prove that telephone consultancy and motivation in times of~     recorded decreasing CPAP therapy usage can improve adherence, neurological function and~     quality of life.~   "
81819|NCT01986439|"~     The purpose of this project is to remove barriers to obtaining contraceptive methods,~     including the most effective and expensive methods. The study seeks to remove the financial~     and knowledge barriers and promote the most effective contraceptive methods to reduce~     unintended pregnancy rates at the population level.~   "
81820|NCT01986426|"~     The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral~     dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune~     responses, as monotherapy or in combination with ipilimumab or pembrolizumab.~   "
81921|NCT01985113|"~     In pre-clinical study the investigators found that the thioredoxin reductase activity of~     serum harbours huge difference between cancer patients and non-cancer patients, the enzyme~     activity elevated remarkably among cancer patients, so the investigators hypothesis that~     this is due to tumor cells loading of the patients, the enzyme activity may harbours huge~     difference between carcinoma tissues and para-carcinoma tissues in early staged non-small~     cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level~     because of removing of tumor.~   "
81821|NCT01986413|"~     Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with~     pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep~     quality and alveolar ventilation in patients with routine NIV initiation after COPD~     exacerbation.~      20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on~     NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one~     with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will~     spend the treatment nights in randomized order under polysomnographic surveillance,~     including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values~     over night the sleep quality will be judged with regards to especially adjusted respiratory~     event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of~     ventilatory drive.~   "
81822|NCT01986400|"~     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes~     and quality of life in adolescents with Juvenile Idiopathic Arthritis~   "
81823|NCT01986387|"~     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes~     and quality of life in adolescents with chronic pain.~   "
81824|NCT01986374|"~     The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest~     that placing HCG into the uterus prior to embryo transfer can enhance implantation.~   "
81825|NCT01986361|"~     The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain~     relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the~     Double-Stopwatch Method (DSW).~   "
81826|NCT01986348|"~     This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of~     oral Selinexor in patients with recurrent gliomas.~   "
81827|NCT01986335|"~     The objectives of this study were to analyze the immunogenicity and reactogenicity of~     DTP/HB/Hib (Bio Farma) combination vaccine.~   "
81828|NCT01986322|"~     The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib~     (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.~   "
81829|NCT01986309|"~     There some evidence regarding the effect of lidocaine for the prevention of nausea and~     vomiting in adults.~   "
81830|NCT01986296|"~     The goal of this prospective, non-randomized, single-arm, single site, feasibility study is~     to develop and collect data to evaluate the safety and initial effectiveness of this~     treatment using this ExAblate transcranial System in the treatment of Medication-Refractory~     OCD.~   "
81831|NCT01986283|"~     This study will determine the relative abuse potential of intact and chewed PF-00345439~     (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release~     (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.~   "
81832|NCT01986270|"~     The objective of this study was to compare the efficacy, toleration and safety of eletriptan~     40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects~     with an acute migraine.~   "
81833|NCT01986257|"~     The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy~     (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.~   "
81834|NCT01986244|"~     The purpose of this study is to prospectively evaluate the functional outcome and patient~     satisfaction of total ankle replacement for tibio-talar osteoarthritis.~   "
81835|NCT01986231|"~     The purpose of this study is to learn if giving multiple doses of a hormone called glucagon~     can cause a major decrease in liver glycogen (animal starch). Glucagon is currently approved~     by the Food and Drug Administration to be given as a large dose to treat severe low blood~     sugar. Our group is studying whether glucagon can be given in repeated small doses to~     prevent hypoglycemia.~   "
81836|NCT01986218|"~     The primary purpose of this study is to evaluate the safety and effectiveness of daily doses~     of BMS-986115 in subjects with advanced solid tumors~   "
81837|NCT01986205|"~     The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on~     long-term symptoms after concussion. This study will enroll 90 individuals with persistent~     problems 1-5 years after a mild traumatic brain injury. These individuals will be randomized~     to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will~     receive 40 daily hyperbaric chamber sessions.~      Participants will have a series of tests and questionnaires before they begin their chamber~     sessions, after they complete 40 sessions, and 12 months after they joined the study. These~     tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain~     imaging, a neurological examination, and an eye exam. Participants will also be asked to~     provide blood for future research.~   "
81838|NCT01986192|"~     The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for~     prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis~     patients and FDA approved the rivaroxaban for prevention and treatment of deep vein~     thrombosis (Nov 2 2012).~      Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome,~     and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e,~     iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis~     if they had been treated with a vena cava filter or a fibrinolytic agent for the current~     episode of thrombosis.~      Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now~     been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk~     of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24~     hours after thrombolysis will be included in this study.~      Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients~     with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter~     insertion and/or venous stent insertion and compare these outcomes with warfarin treatment~     alone.~      This study will be a pilot study to establish the safety and efficacy parameters for further~     studies.~   "
81922|NCT01985100|"~     To confirm or refute recently published data regarding the reduction in post-stroke ischemic~     penumbra, that used SPECT/CT, using the more precise tools of PET/MRI.~   "
81923|NCT01985087|"~     In this study we propose to determine outcomes of patients age 70 or older treated with~     radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a~     post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease~     progresses.~   "
81839|NCT01986179|"~     Professional interpretation improves quality of care for patients with limited English~     proficiency (LEP). However, many health care settings lack access to professional~     interpreters, and even in locations with good access, logistical factors and perceived~     barriers have limited their widespread use. Remote methods of professional interpretation,~     including telephone and video, hold great promise for expanding access, but only limited~     data exist on the relative impacts of these modalities on patient care and provider uptake.~     Comparing how these modalities impact multiple aspects of health care quality, including~     family comprehension, provider communication, and consistency of provider interpreter use~     will inform dissemination of strategies for delivery of safe, efficient, and equitable care~     to LEP families.~      Aim 1: To determine whether randomly assigned remote interpreter modality (telephone versus~     video) impacts parent-reported quality of communication and interpretation, diagnosis~     comprehension, and length of stay (LOS) among LEP Spanish-speaking families seen in a~     pediatric Emergency Department (ED).~      Hypothesis 1: Parent-reported quality of communication and interpretation and parent~     diagnosis comprehension will be higher among families assigned to video interpretation~     compared to telephone interpretation.~      Hypothesis 2: LOS will not differ between families assigned to video and telephone~     interpretation.~      Aim 2: To determine whether assigned interpreter modality is associated with provider~     decision to communicate without professional interpretation.~      Hypothesis 3: Parent-reported provider communication without professional interpretation~     (e.g. using the patient or a family member to interpret for some part of the visit) will be~     lower for families assigned to video interpretation compared to telephone interpretation.~   "
81840|NCT01986166|"~     This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability~     and pharmacokinetics of intravenous (IV) dosing of MEHD7945A in combination with oral dosing~     of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a~     Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation and for which standard therapies~     do not exist, have proven ineffective or intolerable or are considered inappropriate. The~     study comprises a dose-escalation (Stage 1) and an indication-specific cohort expansion~     stage (Stage 2).~   "
81841|NCT01986153|"~     The purpose of this study is to determine if patients on long-term olive oil-based~     parenteral nutrition have an adequate essential fatty acid status and immune status,~     compared to age- and sex-matched healthy controls.~   "
81842|NCT01986140|"~     Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in~     reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or~     adjuvant chemotherapy.~   "
81843|NCT01986127|"~     We study if the administration of intralesional Adalimumab (directly injected in the~     stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared~     with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3~     stenosis as maximum)~   "
81844|NCT01986114|"~     The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I~     disorder.~   "
81845|NCT01986101|"~     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients~     with Bipolar I Depression.~   "
81846|NCT01986088|"~     A previously published, placebo-controlled, head-to-head comparator study found eletriptan~     to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine~     attack. The goal of the current study was to extend the findings of that study by examining~     the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to~     evaluate the comparative efficacy of eletriptan and sumatriptan across additional important~     clinical outcomes. In particular, early response (at 1 hour), sustained response (without~     need for additional treatment) at 24 hours, and consistency of response across multiple~     attacks were examined.~   "
81847|NCT01986075|"~     This study will investigate a treatment strategy in which a computer-assisted behavioral~     intervention will be used to help individuals stop their use of cocaine. A medication will~     be combined with the behavioral treatment among those individuals who do not respond to the~     behavioral intervention alone. The primary hypothesis of the study is that among cocaine~     dependent individuals who fail to respond to an initial trial of behavioral therapy, a~     greater proportion of individuals will benefit from the combined treatment (behavior therapy~     plus medication) compared to individuals in the comparison group.~   "
81848|NCT01986062|"~     This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in~     approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will~     enroll in the study to take open-label AR11 twice daily and undergo dose optimization~     activities for 8 weeks. Patients who achieve a stable dose during the dose optimization~     period will continue participation and will be randomized to take double-blind medication~     (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind~     treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom~     setting utilizing SKAMP and PERMP assessments. At the end of the second double blind~     treatment period, patients will be evaluated for ADHD symptoms in a second laboratory~     classroom setting utilizing SKAMP and PERMP assessments.~   "
81849|NCT01986049|"~     Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean~     section for pain relief.~   "
81850|NCT01986036|"~     High-protein meals have previously been shown to acutely reduce appetite and energy intake.~     More recently, meals higher in calcium have also been shown to increase feelings of~     fullness, circulating insulin and intestinal peptide concentrations and reduce appetite~     sensations.~      This study aims to assess whether calcium and protein act synergistically to acutely~     influence appetite and energy intake.~   "
81851|NCT01986023|"~     The impact of medications used for secondary stroke prevention relies heavily upon patient~     adherence. Adherence is defined as the extent to which a person's behavior - taking~     medication, following a diet, and/or executing lifestyle changes, corresponds with agreed~     recommendations from a health care provider. It is said that optimal adherence to~     medications may reduce the risk of a poor outcome by 26%.~      The purpose of this study which is a non-pharmacologic behavioral study is to encourage~     adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short~     Text Messages). These SMS reminders will support and assist stroke patients to take~     medications as prescribed and on time. We hypothesise that SMS will improve the adherence of~     patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.~   "
81852|NCT01986010|"~     This study will evaluate the safety, tolerability, and immunogenicity of various doses,~     formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160~     administered in a 3-dose regimen in healthy adults. Each treatment arm of 10 participants~     will be accompanied by a placebo arm of 4 participants. The initial treatment arm of HCMV~     seropositive participants will receive V160 Low Dose without adjuvant by intramuscular~     injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal~     injection, and vaccination of HCMV seronegative participants will be performed only after~     review of safety data of previous treatment arms. The purpose of the study is to identify~     vaccine formulations associated with optimal safety profile and HCMV-specific immune~     response for evaluation in subsequent clinical studies of V160.~   "
81854|NCT01985984|"~     The primary and general objective of the clinical introduction of the Standard Follow-up~     Program (SFP) as the current standard of care is to improve the quality of radiotherapy for~     head and neck cancer patients by reducing radiation-induced side effects without hampering~     treatment efficacy in terms of locoregional tumour control and overall survival and to~     systematically evaluate the beneficial effect of newly introduced radiation technology for~     this particular group of patients. The clinical introduction of the SFP will allow for a~     systematic and broad scale quality improvement cycle for head and neck cancer patients~     treated with radiotherapy. In fact, this methodology can be considered a kind of quality~     circle for the clinical introduction of new radiation techniques, aiming at continuous~     efforts for further improvement.~   "
81855|NCT01985971|"~     To estimate the presence of hypoxia in individual lesions after radiotherapy in patients~     with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.~   "
81856|NCT01985958|"~     Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic~     lesion produces an immune response in patients with metastatic carcinoma of the pancreas.~      Secondary Objectives: To characterize the kinetics of an immune response induced by~     radiotherapy. To characterize the dependency of the immune response on prior exposure to~     chemotherapy.~   "
81857|NCT01985945|"~     The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort~     of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a~     second cohort of the same type of and number of patients who, instead of yoga will receive~     standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G~     instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several~     points.~   "
81858|NCT01985932|"~     This study is being done to evaluate the use of MRI during radiation treatment planning to~     identify areas of tumor within the prostate to aid in future treatment planning and~     targeting of prostate cancer. This study will be conducted at the University of Pennsylvania~     Health System. The study is projected to run for 18 months. Subjects will be male 18 or~     older with a prostate cancer diagnosis and treatment plansat the Department of Radiation~     Oncology.~   "
81859|NCT01985919|"~     This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and~     blood specimens to be collected for research purposes, specifically allowing subjects the~     option of sedation during the bone marrow procedure. Samples will be banked for future~     research related to cancer and other diseases. Researchers hope this protocol will improve~     the collection of research correlative and translational biopsy specimens for clinical~     research.~   "
81860|NCT01985906|"~     Complex aortic aneurysms involving major branches have been difficult endovascularly. The~     primary purposes of this study is to evaluate the safety, feasibility, and efficacy of~     multiple overlapping uncovered stents in treating aortic aneurysm while preserving major~     visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and~     renal artery (RA).~   "
81861|NCT01985893|"~     The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab~     compared to lapatinib plus capecitabine as measured by investigator-assessed~     progression-free survival, tumour response and overall survival.~   "
81862|NCT01985880|"~     The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial~     cystitis/painful bladder syndrome~   "
81863|NCT01985867|"~     The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35~     administration for the treatment of functional constipation in children.~   "
81864|NCT01985854|"~     Since neurological testing during neurosurgery, such as somato-sensory evoked potentials,~     motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well~     maintained their wave-form reactivity with total intravenous anaesthesia technique better~     than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is~     usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the~     evoked potential responses during surgery, facilitation of recovery from general anesthesia~     is getting important, because the real neurological physical examination is much more~     sensitive than above electrical evoked potentials to evaluate the results of surgical~     operation.~      We propose to evaluate the recovery parameters after conversion from total intravenous~     anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The~     conversion will be initiated upon completion of the neurophysiological electric evoked~     potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize~     that recovery after conversion to Desflurane will be faster compared to recovery after total~     intravenous anaesthesia alone.~   "
81865|NCT01985841|"~     Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior~     to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to~     induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition~     Bevacizumab (Avastin) is to be administered as early as possible during the disease stages.~     The primary aim of this study is to evaluate the preliminary antitumor activity in terms of~     pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.~   "
81885|NCT01985581|"~     This study looks to examine whether or not INTUNIV extended release can help children aged~     6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving~     Executive Function when added to their usual care stimulant therapy. Executive functions are~     a set of mental processes that include emotional control, planning, organization, working~     memory, inhibition of behaviors, and managing time and space. As children with ADHD usually~     have difficulties with Executive Function, and Executive function difficulties lead to more~     difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release~     to usual stimulant therapy will improve Executive Function scores as rated by parents and~     teachers. Improvements in quality of life will also be measured.~   "
81924|NCT01985074|"~     The aim of the study is to determine whether a nurse-managed telephone-based case-management~     intervention can reduce healthcare utilization and improve self-assessed health status in~     frequent emergency department users.~   "
82169|NCT01981863|"~     It is common practice to use antifibrinolytic agents before and during cardiopulmonary~     bypass. They are not without side effects. The investigators want to show that there is no~     proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary~     bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.~   "
81866|NCT01985828|"~     The primary objective of this study is to document the effectiveness of Cyberknife~     stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk~     localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix~     and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.~      During the prostate-specific antigen era, an ever-increasing percentage of men with prostate~     cancer have presented with clinically localized, potentially curable disease. Although~     conventional treatment options are potentially curative in selected patients, these~     treatments also have drawbacks, including the risk of negative long-term quality of life~     consequences and serious complications.~      The CyberKnife® system is a type of radiation machine that uses a special system to~     precisely focus large doses of x-rays on the tumor. The device is designed to concentrate~     large doses of radiation onto the tumor so that injury from radiation to the nearby normal~     tissue will be minimal.~      Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body~     Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity~     Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT~     boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL~     questionnaires before treatment. Questionnaires will also be completed during follow-up~     visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.~   "
81867|NCT01985815|"~     In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain~     Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which~     electrodes are implanted within specific sub-structures of the brain in order to modulate~     the activity in targeted neural circuits associated with different neurological disorders.~     The results of this novel approach to psychiatric disorders have been optimistic. This study~     aims to investigate wether or not the distance to target location has an influence on the~     outcome.~      In order to deliver DBS, leads containing four electrodes are implanted into the brain~     target in the ventral capsule/ventral striatum (VC/VS). After an optimization period,~     patients enter a triple blind randomised two fazed crossover design of two periods of three~     months. In both crossover branches, patients, evaluating psychiatrist and psychologist are~     blinded for the stimulation conditions. These conditions are stimulation ON (at optimal~     parameters) and stimulation OFF. Stimulation parameters are constant during the entire~     period. During the second crossover branch, stimulation conditions are reversed for all~     patients.~   "
81868|NCT01985802|"~     The purpose of this study is to explore if there is a less harmful way to pace patients with~     first-degree AV-block to ensure that the negative effects inferred by the pacing do not~     outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that~     His-bundle pacing will offer a more physiological mode of pacing in patients with~     first-degree AV-block than conventional pacing.~      Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with~     first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular~     ejection fraction will be included. During the AF ablation three different pacing modes~     (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the~     basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the~     completion of all six pacing protocols (i.e., three modes at two different rates) the~     experimental part of the procedure ends.~      The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary~     end-points will include left ventricular ejection fraction, left ventricular volume, mitral~     regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion~     delay. Since the research study is conducted in parallel with the standard catheter~     ablation, we do not anticipate any additional side effects as a result of the study.~   "
81869|NCT01985789|"~     The asthmatic airway is identified and studied using inhaled agents such as histamine and~     methacholine. The use of antihistamines prior to the test will inhibit the test result if~     histamine is used to cause airway constriction. If using methacholine, this may also be true~     depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are~     used. This study will look at the effect of old and new antihistamines on inhaled~     methacholine challenge response in individuals with mild asthma.~   "
81870|NCT01985776|"~     The first purpose of this study is to define parameters of the trunk neuromuscular functions~     that are pathologically altered in patients with low back pain due to spondylolytic~     spondylolisthesis. The second and also the main purpose of the study is to examine the~     effects of exercise intervention on patients with low back pain due to spondylolytic~     spondylolisthesis. Our overall hypothesis is that specific exercise intervention will~     improve neuromuscular functions of the trunk in patients with low back pain due to~     spondylolytic spondylolisthesis.~   "
81871|NCT01985763|"~     Colorectal neoplasms are the third most common malignancies in the United States. Patients~     with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The~     response rates to chemotherapy range from 35-40%.~      Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal~     cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit~     Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory~     observations also demonstrate that genistein may augment growth inhibition when combined~     with chemotherapeutic agents of 5-Fluorouracil and platinum compounds.~      Based on pre-clinical data the investigators hypothesize that combining genistein with the~     standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve~     response rates in patients. The aim of the study is to add genistein to the regimens of~     FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal~     neoplasms.~   "
81897|NCT01985425|"~     The purpose of this pilot study is to determine the feasibility of comparing colchicine to~     placebo for the prevention of new onset atrial fibrillation in patients undergoing general~     thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.~   "
81898|NCT01985412|"~     The purpose of this study is to determine whether shotgun sequencing technology, which can~     be used to detect donor DNA in recipient plasma, can be used as a rapid, accurate,~     non-invasive method to detect Acute Cellular Rejection (ACR) after heart transplantation.~     Currently, all heart transplant recipients undergo invasive heart biopsies to diagnose ACR.~     Thus, there is an ongoing need to monitor patients for the development of acute and chronic~     rejection, with the primary goal of non-invasive early detection and treatment to prevent~     organ damage.~   "
81872|NCT01985750|"~     Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with~     lung disease, heart failure and cancer. It is often very difficult to treat. The sensations~     of dyspnoea are processed in the brain, and we believe that psychological factors modify and~     amplify these sensations, frequently exacerbating symptoms.~      This study aims to identify the importance of learning in the brain mechanisms of dyspnoea~     by investigating a cohort of patients with chronic breathlessness undergoing pulmonary~     rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and~     group therapy that improves dyspnoea but does not improve lung function. This leads us to~     hypothesise that some of the beneficial effects of PR maybe due to changes in brain~     processing, potentially relating to a learning effect.~      Therefore to probe whether learning is important in the beneficial effects of pulmonary~     rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is~     an antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA)~     receptors in the hippocampus. Our previous study in a similar group of patients demonstrated~     the importance of the hippocampus in breathlessness perception, and we now wish to~     investigate this in more depth.~      The study involves collecting physiological, psychological and clinical measures on in~     conjunction with brain scanning, before, during and once after pulmonary rehabilitation.~     Subjects will either receive d-cyloserine or placebo before the first four pulmonary~     rehabilitation sessions.~   "
81873|NCT01985737|"~     Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into~     blood vessels of premature babies (neonates) to give them nutrition and medications.~     Sometimes these tubes get infected and they need to be removed. Also, the babies need to be~     given medications to treat these infections (antibiotics). PICC infections in neonates are a~     serious problem and we need to find new ways of detecting infections early so that we can~     treat them promptly to avoid complications.~      The purpose of this study is to understand what causes tube infections in neonates and to~     develop a test to detect tube infections early to avoid complications.~   "
81874|NCT01985724|"~     In this trial investigators propose to assess the dose dense, G-CSF supported sequential~     administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of~     docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary~     lymph node positive breast cancer~   "
81875|NCT01985711|"~     The goal of this proposal is to integrate depression services and diabetes care methods into~     a web-based collaborative care system so that a single program can assist patients with~     diabetes and co-morbid depression. The investigators hypothesized that the effect of the~     intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical~     outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood~     pressure). (c) Increasing healthful behavior (medicine compliance, physical activity,~     diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol~     addiction); (e) improving quality of life.~   "
81876|NCT01985698|"~     In this study, the investigators assessed the difference in efficacy and safety among~     robotic-assisted versus laparoscopic versus open abdominoperineal resection for patients~     with low rectal cancer.~   "
81877|NCT01985685|"~     The objective of this study is to determine the effect of thiamine therapy on oxygen~     consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before~     and after thiamine or placebo administration in patients admitted to the ICU and requiring~     mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on~     the metabolic profile of the patients.~   "
81878|NCT01985672|"~     Vitamin D receptors are present and differently expressed in murine endometrium and ovary~     throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D~     receptor null mice experience uterine hypoplasia and impaired folliculogenesis.~      Only few retrospective studies examining the role of vitamin D levels in infertile patients~     have been published up to date, whereas results are strongly contradictory, with some~     supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and~     others demonstrating that vitamin D deficiency does not affect final reproductive outcome.~      Finally, a recent retrospective study postulated that vitamin D deficiency may negatively~     affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D~     deficiency was not correlated with ovarian stimulation characteristics or with markers of~     embryo quality in this study.~      In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates,~     mediated through the endometrium, the aim of the current study was to examine the impact of~     vitamin D levels on pregnancy rates only in an infertile population undergoing embryo~     transfer of frozen-thawed embryos.~   "
81879|NCT01985659|"~     This study investigates peropeative nodal upstaging during anatomical resections for~     non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In~     case of comparable study groups, unchanged pretreatment staging and equal quality of~     pathologic examination, lymph node upstaging is a marker of surgical quality and can be used~     to study the quality of a new surgical technique.~   "
81880|NCT01985646|"~     The present study was designed to compare the efficacy of conservative treatment to~     operative treatment for improvement of constipation symptoms in infants with short or~     normal-segment Hirschsprung disease.~   "
81881|NCT01985633|"~     Osteoarthritis (OA) is one of the most common joint diseases.This disease commonly develops~     in the weight bearing joints of the lower limbs, such as the knee and hip joints.~     Osteoarthritis is considered a chronic degenerative disorder that is characterized by a loss~     of articular cartilage. Pathogenesis can involve all of the major articular tissues~     including cartilage, synovial membrane, subchondral bone and other connective tissues such~     as ligaments and tendons3. There is no effective therapy available today that alters the~     pathobiologic course of the disease.In view of vast role of platelet derived growth factors,~     mesenchymal cells and its safety, this prospective clinical trial is designed in an attempt~     to compare the efficacy of mesenchymal stem cells enhanced with platelet rich plasma in~     early stages of knee osteoarthritis.~   "
81882|NCT01985620|"~     Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination~     rate against influenza are low in spite of national programs. Study goal is to evaluate the~     effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents~     about the importance of influenza vaccination.~   "
81886|NCT01985568|"~     The primary aim of this study is to evaluate the extent to which an exercise intervention~     timed after diet-induced weight loss (rather than initiated at the same time) improves~     exercise adherence and long-term weight loss. An 18 month randomized trial will be used to~     compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and~     sequential behavioral therapy (Sequential BT). The Standard BT group will receive a~     traditional behavioral weight loss program where diet and exercise changes are initiated at~     the same time. The Sequential BT group will receive a program that focuses solely on dietary~     changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months.~     Both groups will be followed for 18 months to assess long-term weight loss. The hypothesis~     is that delivery of diet and exercise interventions in sequence will result in improved~     adherence to exercise and weight loss at 18 months when compared to a traditional program in~     which identical diet and exercise interventions are initiated at the same time. This study~     could identify a strategy that could aid in the development of more effective obesity~     treatment programs and help more people achieve and sustain a weight loss.~   "
81887|NCT01985555|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of volitinib administered to patients with locally advanced or metastatic solid tumors~     and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).~   "
81888|NCT01985542|"~     Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and~     other environmental insults. About 20 % of the European population suffers from pollen~     allergies. Birch pollen allergic rhinitis is the most common allergic disease in the~     Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of~     pollen allergies may be reduced by understanding the molecular biology of the nasal barriers~     during allergic response. Our aim is to observe the effect of season and birch pollen~     immunotherapy on the molecular biology of nasal epithelium and the microbiome.~   "
81889|NCT01985529|"~     The effectiveness of clinic-based pulmonary rehabilitation in advanced Chronic Obstructive~     Pulmonary Disease (COPD) is well established, but few data exist for less severe patients~     treated in alternative settings. The purpose of this study was to investigate whether a~     novel, community-based exercise program was feasible and effective for patients with~     moderate COPD.~   "
81890|NCT01985516|"~     Currently, there are no specific guidelines or best practice suggestions for female~     catheterization. However, there is a consensus that an anesthetic lubricating gel should be~     routinely used in women as well.~      Urethral lubrication can be performed in two different techniques: instillation of the gel~     directly into the urethra or pouring the gel on the catheter's tip. In this study, we will~     evaluate the pain level during female urethral catheterization in each technique.~      Our hypothesis is that the level of pain will be much less if the lubrication agent will be~     instilled directely to the urethra.~   "
81891|NCT01985503|"~     In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose~     tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT~     started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current~     study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up~     study to examine associations between obesity, cardiovascular risk factors, serum metabolic~     profile and BAT structure at baseline and during follow-up several years later. 43 BATPET~     participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52~     FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years.~     The aim of this study is to examine longitudinal associations between BAT function and~     structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.~   "
81892|NCT01985490|"~     Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be~     visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting~     membrane is frequently performed procedure and we suspected that these procedures may affect~     integrity of foveal avascular zone.~      The purpose of the present study is to evaluate the change of foveal avascular zone after~     removal of epiretinal membrane and internal limiting membrane~   "
81893|NCT01985477|"~     The goal of the Phase I portion of this clinical research study is to find the highest~     tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and~     dexamethasone that can be given to patients with relapsed or refractory multiple myeloma~     (MM).~      The goal of the Phase II portion of this study is to learn if ATRA when given in combination~     with lenalidomide alone or with lenalidomide and dexamethasone can help to control multiple~     myeloma.~      In September 2015, the study was terminated due to slow accrual while still a Phase I study,~     no additional registration or research performed under the Phase II portion of the study.~   "
81894|NCT01985464|"~     Allogeneic human umbilical cord tissue-derived stem cells will be injected intravenously~     once per day for 5 days is a safe and useful procedure in inducing remission of RA in~     patients resistant to standard DMARD therapy.~   "
81895|NCT01985451|"~     In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was~     to assess our treatment strategies' availability based on response rates, progression-free~     survival (PFS), median PFS, and toxicity.~   "
81896|NCT01985438|"~     Purpose:~      To compare the effect of prophylactic enteral feeding tube placement (either percutaneous~     endoscopic gastrostomy (PEG) tube or nasogastric (NG) tube) in patients undergoing treatment~     for head and neck cancer (HNC) on nutritional status, quality of life, mental and emotional~     health, rates of clinical complications, and cost of care.~      Study Design:~      Prospective randomized controlled trial with 2 arms and equal allocation ratio~      Study Objectives:~        1. The primary objective is to assess, among HNC patients randomized to receive either~          prophylactic PEG tube or NG tube for enteral support and who are undergoing~          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end~          of 24 weeks after treatment initiation.~        2. The secondary objectives are to assess, among HNC patients randomized to receive either~          prophylactic PEG tube or NG tube for enteral support and who are undergoing~          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end~          of 12 weeks; the rates of complications; quality of life including symptoms of~          depression and anxiety; and cost of care (all related to enteral feeding tube placement~          only) at baseline and at the end of 12 weeks and 24 weeks after treatment initiation.~      Patients and methods:~      Eligible patients will be enrolled consecutively from the gastroenterology outpatient~     clinics at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH&RC), Lahore~     and randomly assigned to receive either PEG tube or NG tube placement prior to commencement~     of treatment. Patients will receive counseling from a trained nutritionist regarding~     adequate nutrition during treatment and enteral feeding tube care. Detailed information~     regarding demographics, cancer location, type and staging, clinical status, nutritional~     status, quality of life, mental and emotional health, and cost of care will be obtained at~     baseline (time at which cancer treatment is initiated) and on 21st day (3 weeks), 42nd day~     (6 weeks), 84th day (12 weeks) and 168th day (24 weeks) after initiating chemoradiation. The~     primary endpoint will be to compare the nutritional status between the two treatment groups~     on an intent-to-treat basis on 168th day (24 weeks) after initiating chemoradiation.~   "
81899|NCT01985399|"~     Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on~     efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse~     neurocognitive function than older individuals on non-EFV-containing ART.~   "
81902|NCT01985360|"~     The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for~     patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced~     chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on~     dialysis). This is a multicenter randomized controlled trial with a target randomization of~     ~1000 patients with advanced CKD and at least moderate ischemia on stress testing.~     Participants will be assigned at random to a routine invasive strategy (INV) with cardiac~     catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or~     to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those~     who fail OMT. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial~     as a companion ancillary trial.~      SPECIFIC AIMS~      A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an~     invasive strategy of routine early catheterization followed by optimal revascularization, in~     addition to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial~     infarction in SIHD patients with advanced CKD and at least moderate ischemia over an average~     follow-up of approximately 4 years compared with an initial conservative strategy of OMT~     alone with catheterization reserved for those who fail OMT. The primary endpoint is time to~     centrally adjudicated death or nonfatal myocardial infarction (MI).~      B. Secondary Aims. Major: To compare angina-related quality of life between the INV and CON~     strategies. Other secondary aims include: comparing the incidence of the composite of~     cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or~     hospitalization for unstable angina or heart failure; composite of cardiovascular death or~     nonfatal myocardial infarction; cardiovascular death; non-fatal myocardial infarction;~     all-cause death; stroke; hospitalization for heart failure or unstable angina~      Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition:~     Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other~     catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary~     Artery Bypass Surgery Phase: Phase III~   "
81903|NCT01985347|"~     The prevalence of anxiety and depression in our OSA population is more than in COPD and the~     general population of North West Adelaide. (principal hypothesis).~      CPAP therapy in OSA population produces a positive effect on the anxiety and depression~     scale.~      The Investigators intend to study the prevalence of anxiety and depression in patients with~     sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP~     has a role in controlling anxiety and depression in depressed and anxious patients with~     sleep apnoea.~      This is a two phase study, in first phase; investigator will assess the prevalence of~     anxiety and depression, in a population with sleep disorders to check whether it is~     different to the prevalence in the COPD population. The prevalence of depression in Sleep~     Disorder population will also be compared with the Adelaide North Western general~     population, which was reported in The North West Adelaide Health Study. According to this~     epidemiological survey, which was conducted from 2008 to 2010, the prevalence of depression~     in Adelaide North Western general population was 20%.During the second phase of the study~     investigator will evaluate the effect of CPAP on anxiety and depression scores in the~     depressed and anxious patients with sleep apnoea by comparing the pre and post CPAP anxiety~     and depression status. The Hospital Anxiety and Depression (HAD) scale will be used to~     assess Anxiety and Depression, which is a well-documented tool for assessing symptoms of~     anxiety and depression in patients with somatic diseases.~   "
81904|NCT01985334|"~     The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide~     and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients~     with moderate COPD who switch from their current COPD therapy. This study aims to provide~     data on how non-exacerbating, but still symptomatic patients with moderate COPD switching~     from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and~     glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study~     is to increase awareness and usage of validated COPD symptoms tools and dyspnea~     questionnaires in order to facilitate clinical assessment and improve early diagnosis of~     symptomatic patients.~   "
81905|NCT01985321|"~     The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,~     is safe and effective in the treatment of cold sores.~      Subjects who meet the requirements to participate in the study will be put randomly, and~     equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or~     2)a group receiving a placebo of just ethanol to treat their cold sore. Neither the subject~     nor the site will know which treatment they will be getting. Once the subject has been~     assigned to a treatment group, they will be given a kit containing a bottle of the treatment~     and special swabs to apply the liquid. The subject will be told to take the kit home and~     wait until they think they are starting to get a cold sore.~      Once a subject begins to feel something or see something that they think is the start of a~     cold sore, they are to immediately call the clinic. Once the clinic confirms that the~     subject is in fact starting to get a cold sore, the subject will be told to open the kit and~     begin treatment. From the start of treatment, there will be twelve (12) treatments, with~     either Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96~     hours (4 days). Each treatment of Merlin or placebo is made up of three (3) applications~     given twenty (20) minutes apart, for a total of thirty-six (36) applications. FOr each~     application, the subject will use the special swab to put the Merlin or placebo solution on~     their cold sore.~      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until~     either the cold sore is completely healed or 14 days from the start of treatment, whichever~     comes first. At each clinic visit the cold sore will be observed to determine at what stage~     it is at or if it has healed. The subject will also be asked how they are feeling.~      Subjects will also be told to record in a diary the time of each application of Merlin or~     placebo. They will also be asked to record how much pain, if any, related to the cold sore,~     that they are feeling.~   "
81906|NCT01985308|"~     The purpose of this study is to show that a magnetic field applied to the front part of the~     brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and~     ameliorate symptoms.~   "
81907|NCT01985295|"~     In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in~     combination with RT pre-operatively given.~   "
81908|NCT01985282|"~     The study is to evaluate the feasibility of the NLA tool, a combined assessment of~     nutritional and physical functional status, to provide personalized advice for the~     independence and mobility of elderly.~   "
81909|NCT01985269|"~     M-DART Study is a randomized clinical trial comparing the effectiveness of a home-based~     modified directly observed antiretroviral (ART) treatment strategy to clinic-based standard~     of care in patients with HIV/AIDS in Port Victoria, Busia, Kitale, Chulaimbo and Khunyangu,~     Kenya.~      Hypothesis 1a: It is feasible to implement M-DART in remote, poverty stricken, high-HIV~     prevalence rural communities in western Kenya.~      Hypothesis 1b: M-DART will be a more effective strategy than standard of care (High-Risk~     Express Care) in reducing mortality and LTFU in patients at the highest risk of dying~     following ART initiation.~      Hypothesis 2: M-DART will be cost effective over the 48-week study period~      Hypothesis 3a: Patients enrolled in M-DART will have higher quality of life scores at 24 and~     48 weeks as compared to the control patients.~      Hypothesis 3b: Patients enrolled in M-DART will have lower HIV related stigma scores at 24~     and 48-weeks as compared to the control patients.~   "
81954|NCT01984684|"~     The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus~     Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.~   "
81995|NCT01983410|"~     The purpose of this study is to better understand why pancreatic cancer develops in some~     people who are known carriers of the gene mutation (an abnormality) called BRCA, or its~     close relative PALB2. The investigators hope to do this by establishing a BRCA/PALB2~     mutation carriers Pancreatic Ductal Adenocarcinoma (the common form of pancreatic cancer)~     Registry. A registry is a database of information.~   "
81996|NCT01983397|"~     The purpose of this study is to compare the effects of different trainings on cognition and~     physical performances in elderly over 80 years.~   "
81910|NCT01985256|"~     This is a multicenter study evaluating the safety and tolerability of Toca 511 administered~     intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who~     have elected to undergo surgical removal of their tumor. Subjects meeting all of the~     inclusion and none of the exclusion criteria will receive a portion of the total dose of~     Toca 511 administered as an intravenous, bolus injection, followed approximately 11 days~     later by the remainder of the dose injected into the walls of the resection cavity at the~     time of planned tumor resection. Approximately 6 weeks later, subjects will begin treatment~     with oral Toca FC taken every 8 hours for 7 days, and repeated every 4 weeks. All subjects~     enrolled in this study will be encouraged to participate in a continuation protocol that~     enables additional 5-FC administration and the collection of long-term safety and response~     data.~   "
81911|NCT01985243|"~     Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains~     high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor~     nutrition contributes to about one-third of child mortality, diminishes cognitive~     development, and is a major determinant of maternal mortality. The specific objectives of~     the 5-year project are to: (1) enhance human capacity of government, civil, and private~     institutions through improvement of knowledge and skills of personnel in agriculture,~     nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of~     local institutions that are not presently met and develop a representative and sustainable~     longitudinal data system to support evidence-based decision-making in programs; (3) increase~     vulnerable households' access to quality services in agriculture/fisheries, nutrition and~     health, and finance; (4) implement integrated intervention activities to improve infant and~     young child and adolescent nutrition outcomes; and (5) examine differential benefits of the~     interventions for diverse vulnerable populations. The project comprises two major~     activities: part I - the creation of a longitudinal data system to support evidence-based~     decision-making in programs, and part II - the implementation of intervention activities to~     improve nutrition outcomes.~      The survey will include demographic, socioeconomic, health, diet, and nutritional status~     information collected annually from a representative same of 1500 households with infants~     (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and~     presented rapidly each year to district program and policy leaders to assist them in~     developing their activity plans for the following year.~   "
81912|NCT01985230|"~     The purpose of this Clinical Study is to investigate the effect of electrical stimulation~     for chronic low back pain.~   "
81913|NCT01985217|"~     Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face~     genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and~     more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion~     is nowadays a major Public Health issue.~   "
81914|NCT01985204|"~     The study hypothesis is that iodine supplementation will lower serum TSH and leptin~     concentrations and thereby improve the lipid and glucose profile.~   "
81915|NCT01985191|"~     Primary Objectives:~      To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in~     patients with solid tumors.~      To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.~      Secondary Objectives:~      To characterize the pharmacokinetic profile of SAR405838 and pimasertib.~      To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.~      To characterize genetic status in tumor tissue and circulating tumor DNA.~   "
81916|NCT01985178|"~     Eating disorders are conditions that are defined by abnormal eating habits that involve~     insufficient or excessive food intake. With regards to treating these disorders, there is an~     increasing interest in fat deprivation due to a lack of proper diet, particularly dietary~     fats such as polyunsaturated fatty acids. These fatty acids are essential components of the~     brain and are important for normal functioning of the body. Since the body cannot synthesize~     these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets~     that lack sufficient fats or under fasting conditions, the imbalance of these fats can~     severely alter brain functions. The investigators want to see if these supplements are well~     tolerated and accepted by adolescent patients with eating disorders.~   "
81917|NCT01985165|"~     The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the~     treatment of patients with knee osteoarthritis.~   "
81918|NCT01985152|"~     The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan~     Trimethylethanolamine in healthy volunteers~   "
81919|NCT01985139|"~     Disturbances in hedonic and motivational processes play a major role in the pathophysiology~     of obesity. To date, experimental approaches for the study of emotional and motivational~     processing rely on subjective assessment scales. We have therefore developed two novel~     computer-generated tasks challenging respectively visual and temporal discrimination~     capacities for a quantitative and objective measurement of the hedonic and motivational~     state in humans. According to the task, the subjects are asked to view and to compare two~     stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in~     greyscale), at each trial, assessing either the size (task A) or the duration of~     presentation (task B). From these considerations, the present project aims at using our~     novel tool to: i) assess the hedonic and motivational state in subjects with obesity, ii)~     compare their responses with healthy volunteers, and iii) establish relationships with~     biological markers known to be highly involved in the regulation of both emotional and~     motivational processes, such as endocannabinoids. The present project should demonstrate~     that the behavioral tests validated in our laboratory are relevant experimental tools for~     the diagnostic/clinical assessment and for the phenotypic characterization of obese~     patients. The application of the test in the therapeutic context could add further~     information about the efficacy and relevance of the chosen therapy. Finally, our project~     will provide information on the biological substrates of hedonic and motivational~     impairments that might become target of therapy in obesity.~   "
81920|NCT01985126|"~     The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment~     regimens in participants with multiple myeloma who have received at least 3 prior lines of~     therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are~     double refractory to a PI and an IMiD.~   "
88720|NCT01894958|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Fragile X Syndrome in adolescent and adult males.~   "
81925|NCT01985061|"~     Albeit the safety of the stem cell transplantation procedure has been greatly improved,~     further refining the intensity of the conditioning is an important issue to explore,~     especially in patients with poor prognosis, the goal being to maintain the very favorable~     safety profile and improve the disease control. This is the goal our prospective trial; we~     aim to prospectively evaluate in a prospective multicenter trial the efficacy of different~     conditioning regimens in patients with high-risk myeloid malignancies.~      The study is a phase II trial randomizing patients between a prospective active control arm~     (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical~     trial in order to avoid the limitations induced by the comparison with historical controls~     in the context of continuously improving practice. Each experimental arm will be conducted~     in parallel according to a standard phase II trial design.~      In addition, this trial will associate four ancillary studies to the main clinical~     objective: 1/ a prospective assessment of the quality of life of the patients over a period~     of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period~     of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic~     study~   "
81926|NCT01985048|"~     1. Primary Objectives:~             -  To characterize cardiometabolic risk factor profiles of patients entering cardiac~               rehab using traditional approaches (eg LDL-C) as well as a more comprehensive~               panel of cardiovascular and metabolic biomarkers. It is hypothesized that the~               comprehensive panel will identify further increased risk that would not have been~               detected using only traditional approaches. Specifically, it is hypothesized that~               a greater percentage of the cohort will be identified with high risk levels of~               LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is~               further hypothesized that the prevalence of elevated Lp(a) and elevated levels of~               inflammatory and insulin resistance markers will be higher in this cohort when~               compared to population norms (HDL, inc reference data).~             -  To assess improvements in laboratory and lifestyle risk factors and rate of goal~               attainment at completion of rehab (eg 3 months). This objective is primarily~               descriptive, and improvements in traditional risk factors (eg LDL-C) will be~               compared to existing published data. Improvements in non-traditional risk factors~               (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been~               extensively investigated.~             -  To determine which attributes at baseline best predicted recurrent events and~               re-hospitalizations assessed one year later.~        2. Secondary/Developmental Objective:~             -  To inform and guide development of a subsequent study protocol designed to compare~               outcomes associated with biomarker-guided personalized treatment plans vs.~               standard of care in the cardiac rehab setting.~   "
81927|NCT01985035|"~     Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body~     composition and energy expenditure. The objective of this study is to evaluate the influence~     of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of~     both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary~     intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN~     with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg~     protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and~     CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy~     diet (less 30% of daily energy expenditure). At baseline and one month after the beginning~     of the program the following evaluations will be conducted: total energy expenditure~     measured by doubly labeled water method, resting energy expenditure and thermic effect of~     food by calorimetry, polysomnography analysis, body composition by pletysmography, food~     consumption by three days of food diary, blood collection for analysis of lipid profile,~     visceral proteins, hormones related to control of body weight and inflammation. As~     hypothesis we believe that apneic obese individuals have greater difficult in weight loss~     and loss more free fat mass than the obese no apneic and that diets with more protein can~     contribute to greater weight loss, better body composition and energy expenditure in these~     population.~   "
81928|NCT01985022|"~     The major purpose of this study is to directly compare two parent intervention conditions~     for children diagnosed with autism spectrum disorders at 18 months of age to document the~     effectiveness.~   "
81929|NCT01985009|"~     The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver~     disease in the western world. It can progress from steatosis to non-alcoholic~     steatohepatitis (NASH), and then onto cirrhosis where there is a concomitant risk of~     developing hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high,~     ranging from 16 to 31% in the general population, up to 80% in the obese populationand up to~     96% in severely obese patients.~      Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of~     patients with NAFLD, although it has several limitations. LB has a potential sampling error,~     is an invasive and often painful procedure.~      The natural history of patients with NAFLD is generally determined by the extent of liver~     fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For~     patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide~     information on the patient's course and/or response to treatment.~      Several clinical studies have shown the benefit of measuring hepatic stiffness with the~     FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and~     cirrhosis has been demonstrated in normal and overweight patients affected with chronic~     hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD.~      Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter~     (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled~     transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology~     cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation~     between steatosis assessed histologically and using CAP.~      The main objective of this prospective study is to evaluate the diagnosis accuracy of the~     Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in~     patients with NAFLD to assess liver steatosis using biopsy as a reference.~      The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy~     within 2 weeks of fibroscan examination and followed by the Hepatology service of four~     centers in United Kingdom.~      Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study:~     Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe.~      The inclusion period is from 18 to 24 months. Starting date: January 2014. End of~     recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days,~     depending to the exams calendar.~   "
81930|NCT01984996|"~     The primary objective of this study is to evaluate patient quality-of-life (QOL) after~     inguinal hernia repair. Carolinas Comfort Scale (CCS) assessments will be held at regular~     intervals.~      The secondary objective of the study is to follow short-term and long-term study-related~     complications/adverse events.~   "
82235|NCT01980992|"~     This study is being done to learn about the medical effects, the safety, and the immunologic~     effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out~     whether subjects can develop the ability to eat wheat (the food allergen) regularly without~     allergic symptoms after stopping the study treatment.~   "
81931|NCT01984983|"~     The Phase I study will assess the basic safety, tolerability, and immunogenicity of a~     DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by~     electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will~     comprise evaluation of intradermal or intramuscular administration by electroporation.~     Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0~     mg/ml) for each route of administration. Electroporation will be administered using the~     TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional~     group of subjects will serve as a placebo control, receiving injections of saline with~     electroporation. The overall goal of this study will be to determine if further human~     clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection~     of dose and route of administration for future studies.~   "
81932|NCT01984970|"~     1. Double-lumen tube intubation is difficult, compared with single lume tube.~        2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both~          in anesthetized and awake patients.~        3. But there was little information about McGrath Series 5 videolaryngoscope for~          double-lumen tube intubation.~   "
81933|NCT01984957|"~     To isolate biomarkers of ALS in muscle~   "
81934|NCT01984944|"~     Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by~     deficits in social communication, delay in language and repetitive behaviors. Results from~     genetic studies reveal one pathway associated with susceptibility to ASDs, which includes~     synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the~     genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently~     observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with~     ASD and search for circadian rhythms genes polymorphisms.~   "
81935|NCT01984931|"~     This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will~     be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic~     rotator cuff repair under general anesthesia.~   "
81936|NCT01984918|"~     To conduct a prospective randomized controlled study to identify predictors for colonoscopy~     non-attendance and examine the efficacy of SMS reminder to improve the non-attendance rate.~   "
81937|NCT01984905|"~     Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of~     false lumen expansion and risk of rupture. Data of literature give us some indications about~     prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality~     at 3 years despite follow-up.The only known predictive factors are the initial diameter of~     more than 4 cm and the persistence of a false lumen patent.However, actual means of~     follow-up do not allow to predict severe complications. The aim of the sudy is to propose a~     diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections~     treated medically.~      The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such~     patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year~     and/or of an aortic dissections extension at 1 year. The secondary objectives are to~     evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging~     results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100~     patients to be included in 3 years History of chronic type B aortic dissection, treated~     medically, evolving since more than 1 month and less than 5 years.~      Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the~     identification of patients at high risk of evolution. Elaboration of a decisional algorithm~     about follow-up modalities of chronic aortic dissections. Demonstration of a correlation~     between aortic diameter growth or aortic dissection extension and intensity of marker~     fixation with 18-FDG-PET-Scan.~   "
81938|NCT01984892|"~     The purpose of this study is to test the safety of a course of injections containing~     Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with~     a needle.~      Poly-ICLC is a compound that has been used to help the body in its fight against cancer.~   "
81939|NCT01984879|"~     The purpose of this study is to investigate the vaccination status, knowledge about~     vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel~     diseases~   "
81940|NCT01984866|"~     This project aims to determine whether biopsy using radiofrequency is a procedure suitable~     for this patient selection. Findings from biopsy will be correlated with the conventional~     surgery ones. If the technique is validated to predict the presence or absence of residual~     tumor, breast surgery could be avoided in cases of absence of tumor.~   "
81941|NCT01984853|"~     This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary~     syndrome that will be conducted in the Emergency Department at Henry Ford Hospital.~      The standard protocol for evaluating patients in the Emergency Department for possible acute~     myocardial infarction includes the measurement of cardiac troponin over 3 hours. Subjects~     presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood~     draw protocol. The study is blinded to treating physicians and does not change current~     standard of care. After informed consent patients will have blood samples drawn at 0, 30~     minutes, 1 hour and 3 hours.~      Serum from the samples will be stored in a -80 research freezer to be evaluated at a later~     time as new cardiac markers for acute coronary syndrome are developed.~   "
81942|NCT01984840|"~     There are two main aims in this study. The first objective is to evaluate whether a~     particular telehealth solution, in addition to standard treatment and care, lead to a~     significant decrease in the mortality and an increase in health related quality of life for~     patients suffering from COPD that may benefit from telehealth compared with only standard~     treatment and care. The second objective is to examine the additional costs of the~     telehealth solution and assess whether this solution is a cost-effective way to care for~     patients with COPD across patients and municipality districts.~      It is hypothesized that telehealth care will increase patients quality adjusted life years~     at both the cluster and individual level compared to usual practice, since no difference in~     mortality and a higher health related quality of life is expected. Furthermore, it is hoped~     that there will be a 30% reduction in the number of admissions and readmissions to hospitals~     and a 30% reduction in the number of outpatient visits resulting in fewer costs for~     hospitals. However, it is uncertain as to whether these savings are offset by other costs~     such as more visits to general practitioners, community care or the implementation costs.~   "
81943|NCT01984827|"~     High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic)~     have both been shown independently to affect heart activity in healthy volunteers as~     recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the~     time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In~     this study, the investigators want to find out whether moxifloxacin and hyperglycaemia cause~     QTc prolongation in Type 1 diabetic patients. The investigators also want to assess whether~     C-peptide (a fragment if insulin normally found in the blood but not present in not present~     in the blood of Type 1 diabetics) which has the opposite effect on heart activity i.e it~     shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as~     this may be useful for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac~     Death' which is more common in diabetic patients compared to healthy volunteers.~   "
81944|NCT01984814|"~     The effect of autologous bone marrow mononuclear cells on duration of survival in~     Amyotrophic Lateral Sclerosis patients.~   "
81945|NCT01984801|"~     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan~     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and~     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),~     after topical administration on healthy subjects and acne patients. Study SCD117225 will be~     a randomized, single-blind, three part study, to evaluate the primary irritation potential~     (Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel~     applied to the intact skin of healthy subjects, and the facial irritation potential of one~     or two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1~     and Part 2 the following 6 treatments will be applied using individual patches: (A) 200~     milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of~     0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled~     water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in~     sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive~     irritant control), and (F) Patch only (patch control). Each treatment will be randomized to~     one of six designated locations on either upper arm or other locations, such as the lower or~     upper back, within each subject. The same treatment will be reapplied to the same location~     on subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for~     21 days in Part 2. In Part 3, each patient will apply a thin coat of one or two~     concentration of GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once~     daily for 28 days. Parts within Study SCD117225 and Study SCD117226 will have~     interdependencies. No significant primary irritation signal in Study SCD117225 Part 1 would~     allow initiation of Study SCD117226 Part 1 (single dose application). Once safety,~     tolerability and exposure information are determined in Study SCD117226 Part 1, Part 2 of~     Study SCD117225 may be initiated along with Part 2 (14-day repeat dose application). No~     significant cumulative irritation signal (study SCD117225 Part 2) in combination with~     adequate 14-day safety (study SCD117226 Part 2) would allow initiation of Part 3 of Study~     SCD117225.~   "
81946|NCT01984788|"~     The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic~     treatment is safe and effective in reducing the number of acute attacks in patients with~     hereditary angioedema.~   "
81947|NCT01984775|"~     This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3~     concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in~     healthy subjects. Results from this study will be considered when selecting the~     concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and~     efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30~     evaluable subjects complete the study. The total duration of subject participation may be up~     to 50 days.~   "
81948|NCT01984762|"~     Obesity is a growing epidemic throughout the world and is followed by increasing incidence~     of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major~     objective, although difficult to achieve with medical treatments. Many recent studies~     demonstrated that bariatric surgery has the potency to achieve marked and sustained weight~     loss, and is also associated with a significant improvement in control of type 2 diabetes.~     The principal aim of this study is to compare two types of bariatric procedures, the~     Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that~     these procedures have equal efficacy with regard to resolution of type 2 diabetes.~   "
81949|NCT01984749|"~     The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral~     and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for~     cerebral and cardiorenovascular disease.~   "
81950|NCT01984736|"~     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites~     after a single oral dose in subjects with mild, moderate and severe hepatic impairment~     compared with subjects with normal hepatic function.~   "
81951|NCT01984723|"~     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites~     after a single oral dose in subjects with mild, moderate and severe renal impairment~     compared with subjects with normal renal function.~   "
81952|NCT01984710|"~     Major depressive disorder is a common disease. For many people, conventional treatments such~     as antidepressants are very helpful in relieving the symptoms of this condition. But as many~     as 30% of patients with depression have less than a full response or become resistant to~     conventional treatments. When treatment resistance develops, the depression becomes a~     chronic disease with a very significant burden of morbidity and mortality. The reasons that~     some patients develop Treatment Resistant Depression (TRD) are not known. One current theory~     for depression is that it results from the dysfunction of a network of regions in the brain~     and that in treatment resistant patients the network is permanently stuck in the~     dysfunctional state. We have been investigating an experimental treatment for treatment~     resistant depression (TRD), based on this network theory known as subcallosal deep brain~     stimulation (SCC DBS). This treatment involves placement of electrodes in a specific region~     of the brain (subcallosal cingulate cortex, area 25) and then stimulating that area with~     electricity, which resets the regulation of the network resulting in a significant~     antidepressant response. While still experimental our results suggest this may eventually be~     a useful treatment for some patients with TRD. The experiment described in this application~     is to use a new DBS device that can record the electrical activity in the brain around the~     site of stimulation. The electrical activity is known as Latent Field Potential (LFP) and is~     a reflection of the activity if the neural network. The new DBS device is an experimental~     device that has not been approved by the Food and Drug Administration (FDA), but allows for~     simultaneous recording of LFP while stimulation is being delivered. The device is~     manufactured by Medtronics and is known as Activa Primary Cell + Sensing(PC+S), but because~     it can be used to record the brain electrical activity it is also known as the Brain~     Radio. The Brain Radio is based on an approved device commonly used for DBS for other~     conditions that has the added sensor capacity. The stimulation system is identical to that~     in the approved device. The goal of this investigation is to use the Brain Radio to study~     LFP in the brains of people with TRD before and during active stimulation. The ultimate goal~     is to understand the neural network that causes TRD and the changes that DBS cause in that~     network that results in the antidepressant effects. We will recruit 10 patients with~     advanced TRD and implant them with the Brain Radio system. The recording system will be to~     record LFP over 3 years, while patients receive stimulation. A brief discontinuation study~     will be conducted after 6 months of stimulation when the device will be turned off and~     patterns of LFP changes will be recorded. All LFP measures will be correlated with the~     primary clinical response outcome metric, the Hamilton Depression Rating Scale. The~     knowledge gained with this experiment will be invaluable to understanding the basic~     pathology of depression and the antidepressant response. This is a unique, first in humans~     test of this device and as such the results are expected to impact our understanding of~     depression at a fundamental basis.~   "
81953|NCT01984697|"~     This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14~     years of age and in young women 16 to 26 years of age. From this study, the goal is to~     establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in~     boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody~     response that is not inferior to that observed in young women 16 to 26 years of age who~     received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to~     establish V503 efficacy).~   "
81955|NCT01984671|"~     Persistent pain is a major challenge for patients who undergo hematopoietic stem cell~     transplant (HSCT) and is related to more fatigue, more physical disability, poorer quality~     of life, and poorer medical adherence. There is a need to examine strategies for managing~     pain in HSCT patients that can complement existing analgesic regimens. Strong evidence~     suggests that cognitive and behavioral factors play an important role in HSCT patients'~     ability to manage their pain. The investigator has found that HSCT patients having low~     levels of confidence (i.e., self-efficacy) in their ability to control pain and high use of~     maladaptive coping strategies (i.e., pain catastrophizing) experience increased pain and~     disability. A psychosocial intervention that modifies patients' cognitive and behavioral~     pain coping strategies may benefit HSCT patients. Protocols, particularly Pain Coping Skills~     Training (PCST), have been developed for reducing pain and improving quality of life in~     patients with persistent pain. However, HSCT patients with persistent pain face a number of~     unique challenges that must be considered when applying a PCST protocol. The investigator~     proposes to develop and test a Mobile Health Pain Coping Skills (mPCST) protocol for HSCT~     patients with persistent pain to meet the challenges of HSCT patients with pain as they~     transition from hospital based care to their home environment. The first aim of this study~     is to use an iterative development model to design a mPCST intervention protocol for HSCT~     patients that targets increasing self-efficacy for pain control and decreasing pain~     catastrophizing. The study team will use focus groups with patients and HSCT providers to~     guide development along with user testing with HSCT patients having pain. The second aim of~     this study is to use a small randomized controlled trial to examine the feasibility,~     acceptability, and engagement in the developed mPCST protocol. The third aim is to obtain an~     estimate of the effect size of the developed mPCST protocol on decreased pain, pain~     disability, physical disability, and adherence to post-transplant lifestyle recommendations~     impacted by pain when compared to a standard care control condition. Proposed innovative~     features of the mPCST protocol that will be developed include: extensive input from PCST and~     HSCT experts and HSCT patients with pain; an initial session prior to discharge with~     subsequent sessions occurring at home via video-conferencing; incorporation of strategies to~     decrease the impact of pain on adherence to critical post-transplant lifestyle~     recommendations; a real-time daily assessment system with subsequent tailored feedback. If~     the developed mPCST protocol demonstrates feasibility, acceptability, engagement, and~     promising effect sizes to influence pain and other indices of quality of life, a larger NIH~     grant will be sought to examine this protocol in a larger sample of patients, test the~     protocol against an active treatment, and investigate a broader array of outcomes (e.g.,~     medication adherence). This mPCST protocol could also be examined in other patient~     populations with pain facing similar challenges (e.g., live far from medical center, travel~     limitations).~   "
81956|NCT01984658|"~     This study is a prospective open phase-I study to investigate the safety and tolerability~     for administration of repeated doses of ALECSAT.~      Each patient will be followed up to 24 weeks from the initial blood donation to the last~     visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT~     is administered. The following administrations are given with 3 weeks intervals, i.e. at~     week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are~     followed by close examinations during the study period and at regular visits after~     completing the study as advised by the patient's responsible physician.~   "
81957|NCT01984645|"~     New York-Presbyterian Hospital has created a system that notifies its primary care providers~     whenever their patients are admitted to the hospital. In this study, the investigators want~     to evaluate how accurate this system is and how it is affecting the primary providers and~     their health care delivery.~   "
81958|NCT01984632|"~     The aim of this study is to test our hypothesis that the use of unidirectional knotless~     barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine~     wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.~   "
81959|NCT01984619|"~     To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula~     for the treatment of forehead wrinkles.~   "
81960|NCT01984606|"~     The purpose of this study is to assess safety and efficacy of empagliflozin compared to~     sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on~     treatment with metformin and have insufficient glycaemic control. The study will assess~     non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.~   "
81961|NCT01984593|"~     The purpose of this study is to determine the effects of a short yoga program practiced~     daily at home on blood pressure, quality of Life and stress. The subjects of the study are~     primary health care patients diagnosed with hypertension, with or without current~     medication.~   "
81962|NCT01984580|"~     Using orally administered zinc to patients already diagnosed with the pre-cancerous~     condition, Barrett's Esophagus, this study is asking two questions:~        1. can this zinc administration cause molecular-level changes in the Barrett's tissue?~        2. are the changes measured indicative of chemopreventive action by zinc regarding cancer~          progression?~   "
81963|NCT01984567|"~     Background of the study:~      We now know that plant sterols can oxidize, which results in the formation of~     oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic~     components, however this relation has not yet been studied in humans. In our previous study~     (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations~     are linked to oxidative stress status (i.e. we were able to identify high and low sterol~     oxidizers). From the literature is known that especially type II diabetics and IGT subjects~     are characterized by increased oxidative stress markers and reduced antioxidant capacity.~     For this reason we also want to evaluate the oxyphytosterol concentrations in this~     population. Moreover, we know propose to evaluate the effect of antioxidant supplementation,~     i.e. vitamin E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic~     patients. If possible to lower oxyphytosterol concentrations in these populations this is~     obviously beneficial in case oxyphytosterols turn out to be atherogenic. The major objective~     of the present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid~     (600 mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired~     glucose tolerance or type 2 diabetes.~   "
81964|NCT01984554|"~     The primary objective of this study is to compare the total costs to sites and payers of~     administering IV iron over the 30-day observation period for subjects with IDA who receive~     Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and~     ferumoxytol.~   "
81965|NCT01984541|"~     The objective of this study is to determine the biological activity of Artemisia vulgaris~     allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
81966|NCT01984528|"~     The objetive of this study is to determine the minimum amount of Alternaria alternata~     allergen extract producing in a positive skin reaction.~   "
81967|NCT01984515|"~     The purpose of this study is to implement an evidence-based Referral Management System that~     will address patient and system-level barriers to the uptake of evidence-based psychotherapy~     for PTSD by Veterans Affairs primary care patients.~   "
81968|NCT01984502|"~     The feasibility of reducing fractions in early-stage laryngeal cancer has not previously~     been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent~     dose fraction reduction study.~   "
81969|NCT01984489|"~     SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the~     efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type~     2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control~   "
81970|NCT01984476|"~     As the spinal cord injured population ages, these individuals are being exposed to an~     increased prevalence of age-associated diseases, which coupled with the secondary~     complications of the injury may contribute to the reduced life expectancies. Decentralized~     autonomic regulation in persons with SCI results in a multitude of cardiovascular changes,~     which may contribute to accelerated aging. Adverse cardiovascular changes may have~     deleterious effects on cerebral blood flow dynamics and an increase in cerebral vascular~     resistance index in individuals with SCI during cognitive testing. Deficits in memory and~     processing speed in individuals with SCI may relate to cardiovascular and cerebrovascular~     dysfunction. Identifying the associations between healthy aging versus premature or~     accelerated aging in organ system function in the SCI population is an important first step~     towards prevention and amelioration of these changes. Therefore the study objectives are to~     compare, among individuals with SCI, age-matched non-SCI and older non-SCI individuals~     arterial stiffness and cerebral vascular resistance index; memory, processing speed, and~     executive function; and volume of white matter hyperintensities. 60 individuals with SCI, 20~     age-matched non-SCI controls, and 20 older non-SCI controls will be recruited for this~     study. All potential subjects will undergo a two-part screening process which consists of an~     initial screening via telephone and a detailed, in-person screening. Eligible subjects will~     be invited to participate in a 4 hour laboratory visit during which their arterial~     stiffness, blood pressure, heart rate, respiration rate and, blood flow to the brain will be~     monitored at rest and during a comprehensive series of cognitive tests. A subset of the~     participants will be asked to take part in an MRI brain imaging session: 40 persons with~     SCI, 10 age-matched non-SCI and 10 older non-SCI. Eligible subjects will be asked to~     participate in a 1 hour MRI/functional magnetic resonance imaging(fMRI) session.~      We hypothesize that arterial stiffness and cerebral vascular resistance index will be~     increased in the SCI group compared to the age-matched non-SCI but will be comparable to the~     older non-SCI groups. In addition, we hypothesize that the prevalence of mild to moderate~     cognitive impairments in memory, processing speed, and executive function will be increased~     in the SCI individuals compared to the age-matched non-SCI but will be comparable to the~     older non-SCI individuals.~   "
81971|NCT01984463|"~     This study is designed to assess the impact of epidural morphine on:~        -  The incidence and severity of shoulder pain following a thoracotomy.~        -  The need for additional analgesics, such as opioids for the relief of shoulder pain.~        -  Its safety profile compared to epidural fentanyl following a thoracotomy.~      The basic hypothesis of this study is that an infusion of epidural bupivacaine and morphine~     initiated after the induction of anesthesia and continued until 72 hours postoperatively~     will reduce the incidence and severity of shoulder pain following a thoracotomy when~     compared to an epidural infusion of bupivacaine and fentanyl.~   "
81972|NCT01984450|"~     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:~     Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced~     Chondrogenesis (MCIC).~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: This is a prospective study. The participating patients will be divided into~     two groups, each group receiving either one of the treatment modalities. This study will not~     be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by~     Professor A. A Shetty, who is one half of the team that devised both techniques.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each arm.~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and~     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm~     scores; cartilage growth will be measured by the MOCART score.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
81973|NCT01984437|"~     The purpose of the registry is to gather both retrospective and prospective case data on the~     use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in~     accordance with the approved intended use. For prospective cases, follow-up patient data~     will be collected at 14 days (± 5 days) post procedure to assess treatment success, primary~     patency of intended targeted vessel region, and adverse events.~      The data will be analyzed for medical education, societal presentation, and/or publication~     by the investigators.~      Over the next 2+ years, physicians who meet the selection criteria will be invited to~     participate in the registry.~   "
81974|NCT01984424|"~     The study is divided into 3 parts (A, B, C). Part A is a double-blind, placebo-controlled,~     two-period cross-over rechallenge of atorvastatin 20 mg. Part B is a 24-week double-blind,~     double-dummy comparison of evolocumab and ezetimibe. Part C is a 2-year open-label~     evolocumab extension. The primary hypothesis is that evolocumab will be well tolerated and~     will result in greater reduction of LDL-C than ezetimibe, defined by the mean percent change~     from baseline at Weeks 22 and 24 of Part B and percent change from baseline at Week 24 of~     Part B, in statin-intolerant hypercholesterolemic subjects.~   "
81975|NCT01984411|"~     Cardiac catheterization is the most important test for the evaluation of cardiac patients.~     Since the beginning of the cardiac catheterization procedure, we have used the femoral~     artery puncture as a gateway for those procedures. Recently it is used more often the path~     for the radial. Using this approach has gained many followers worldwide and has been used~     almost routinely in our country but has not gained popularity because many interventional~     cardiologists argue that the transradial procedure is much more time-consuming and~     difficult.~      Research question: Are there differences in the total procedure time path between radial and~     femoral vascular to perform cardiac catheterizations?.~      This research focuses on the search for information to determine whether there are~     significant differences when the variables under study. This research is justified by the~     need to evaluate the two techniques in use and the lack of studies evaluating and comparing~     the radial arterial access in comparison with femoral access route which is widely used in~     all services hemodynamics national and international. The lack of research on the subject~     has made the use of the transradial procedure routinely not being done, because they have~     the idea that it is much more time-consuming and technically more difficult than the~     procedure performed by the femoral approach, hence Hemodynamics specialists, not everyone~     wants to start implementing the systematic use of the radial approach for cardiac~     catheterization studies.The main objective of this project is to determine the~     non-inferiority in terms of total procedure time path between radial and femoral vascular to~     perform cardiac catheterizations. Secondary objectives: the difference in time of puncture,~     duration of the procedure and recovery. Incidence of vascular complications and techniques~     between radial and femoral, presence of complications at 8 days of follow-up. Our aims to~     check through the results, if the difference in each of the variables favoring either of the~     two techniques and to determine the non-inferiority of one technique over the other in terms~     of ease and effectiveness of both procedures. The type of study is a controlled clinical~     trial open, randomized, non-inferiority. The study population will consist of patients who~     have been told the diagnostic cardiac catheterization, they are sent to the General Clinic~     Northern institution.~   "
81976|NCT01984398|"~     To determine and compare the pharmacokinetics (PK) of a single dose of each of two~     formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to~     determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25~     mg Androxal administered to healthy male volunteers.~   "
81992|NCT01984190|"~     Venous thromboembolic events (VTE), either deep vein thromboses or pulmonary emboli, are~     important complications in patients undergoing knee or hip arthroplasty. This multicenter~     Clinical Registry is aimed at collecting large volume clinical effectiveness data of~     ActiveCare+S.F.T® mobile compression device +/- aspirin in lowering the potential risk of~     venous thromboembolism (VTE) prophylaxis in patients undergoing primary lower extremity~     total joint arthroplasty. The results can then be compared to pharmacology protocols.~   "
81993|NCT01984177|"~     This study will, in a sample of cocaine-dependent and healthy control subjects, administer~     corticorelin and compare dopamine release between groups. Dopamine release will be measured~     using PET neuroimaging with the radiotracer [11C]-(+)-PHNO.~   "
81977|NCT01984385|"~     Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the~     incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years~     presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences.~     This pilot study will assess the feasibility of a larger prospective international cohort~     study. After eligibility has been confirmed and informed consent has been obtained,~     participants will be registered in the study. Troponin level, complete blood counts and~     serum creatinine level will be collected at day 1 through day 10 post admission. CAM~     instrument will be employed at admission and once daily post admission day 1 through day 10.~     FIM Instrument will be administered within 72 hours of admission to establish pre-fracture~     functional independence and disability. Patients will be contacted by research personnel by~     telephone 30 days after study registration.~   "
81978|NCT01984372|"~     This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to~     assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in~     patients with diabetes mellitus requiring insulin therapy under normal clinical practice~     conditions.~      A total of 4000 patients will be enrolled to investigate long term (3 years of treatment)~     safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an~     early stage of the PMS more precisely. At the time of enrolment the patients will be~     randomly allocated to either 3 years or 6 months observation group.~   "
81979|NCT01984359|"~     To assess in an exploratory manner, the pronostic utility for locoregional control,~     progression-free and distant metastasis-free survival of a pre-therapy and post-therapy~     blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal~     cancer patients. This will entail analysis of both initial pre-therapy HPV level as a~     continuous variable and initial post-therapy HPV level as a dichotomous variable.~   "
81980|NCT01984346|"~     This is a multi-center, open label, randomized pivotal study evaluating the safety and~     efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF~     patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug~     (AAD).~   "
81981|NCT01984333|"~     Trichotillomania (TTM) remains one of the most poorly-understood and inadequately-treated~     conditions. Research has shown poor response inhibition (RI; the ability to inhibit~     inappropriate but potent response) as an important cognitive feature of TTM. Investigators~     have developed a computerized training program that aims to improve RI. Fifty children with~     TTM will be randomly assigned to (a) online 8-session RI training (n=25), or (b) 1-month~     waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month~     follow-up. Investigators hypothesize that the online RIT will show greater improvement in~     TTM symptoms and RI capabilities at post-treatment and 1-month follow-up assessments,~     compared to the waitlist condition. This study will help develop an effective cognitive~     intervention program for TTM.~   "
81982|NCT01984320|"~     The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.~   "
81983|NCT01984307|"~     To characterize and estimate the size of different populations with a history of acute~     coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality~     rates healthcare resource utilization and atherothrombotic events) among patients with a~     history of myocardial infarction (MI) 1-3 years ago and additional risk factors for~     atherothrombosis.~   "
81984|NCT01984294|"~     This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF)~     fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive~     or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV)~     infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of~     treatment, approximately 60 having had prior treatment with a regimen containing pegylated~     interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive~     versus treatment-experienced and by HCV genotype (1a versus 1b).~   "
81985|NCT01984281|"~     The purpose of this study is to determine whether a pedometer-based unsupervised exercise~     program is more effective than a general exercise recommendation to increase lifestyle~     physical activity in adult patients with asthma.~   "
81986|NCT01984268|"~     Adenocorticotrophic Hormone provides safe and effective treatment to induce disease~     remission in rheumatoid arthritis patients with active disease due to an inadequate response~     to methotrexate.~   "
81987|NCT01984255|"~     This is a Open label, two-arm, randomized, two agent, single center trial.~   "
81988|NCT01984242|"~     This multicenter, randomized, open-label study will evaluate the efficacy and safety of~     atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in~     patients with previously untreated locally advanced or metastatic renal cell carcinoma.~     Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus~     Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab~     alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally~     daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease~     progression, patients in Arms B and C will be given the option to receive combination~     treatment with atezolizumab and Avastin.~      Patients enrolled into arm B (atezolizumab alone) in Europe (including France, Italy, the~     United Kingdom, Romania, Spain, Germany, the Czech Republic and Poland) are not eligible to~     cross over into arm A to receive combination treatment with atezolizumab and bevacizumab~     following disease progression, per local regulatory requirement.~   "
81989|NCT01984229|"~     This open-label study will investigate whether multiple oral doses of posaconazole affect~     the single dose pharmacokinetics of alectinib in healthy volunteers.~   "
81990|NCT01984216|"~     The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth~     II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.~   "
81991|NCT01984203|"~     This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for~     patients diagnosed with Rotator Cuff Tendinopathy is superior to Standard Low-Load~     Exercises (LLE).~   "
81994|NCT01984164|"~     The aim of this study is to conduct a 1-year double blind randomized control trial comparing~     candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive~     impairment in their effects on executive function, neuroimaging markers, and vascular~     indicators.~   "
81997|NCT01983384|"~     There is recent, but limited evidence to suggest that anesthetic depth is associated with~     poor postoperative cognitive outcomes. Specifically, several studies suggest that deeper~     level of anesthesia is associated with increased incidence of postoperative delirium and~     longer-term cognitive decline. In fact, some suggest that older patients undergoing surgery~     should routinely be monitored with an anesthetic depth monitor to allow the titration of~     anesthetics or sedation medications to lighter levels to promote better postoperative~     cognitive outcomes. However, such a practice has never been validated or proven to be~     feasible or safe. Accordingly, the investigators plan an exploratory study to determine the~     feasibility and safety of randomizing patients undergoing major surgery to receive deep vs.~     light anesthetic levels during surgery.~   "
81998|NCT01983371|"~     The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced~     MRI in detecting lymph nodes that have been invaded by tumor cells in patients with~     colorectal cancer.~   "
81999|NCT01983358|"~     The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289~     in healthy male subjects.~   "
82000|NCT01983345|"~     The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a~     correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as~     a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one~     corresponding to the anatomical defect (as defined by the last upper normal vertebra before~     the defect).~      The purpose of this study is to introduce in France an innovative technique for prenatal~     repair of myelomeningocele until now developed only on the American continent.~   "
82001|NCT01983332|"~     The purpose of this study is to examine the impact of an introduction to the~     occupation-based theory (MOHO) on the clinical reasoning of therapists working with cancer~     clients.~   "
82002|NCT01984138|"~     This study is investigating whether breast cancer patients who experience vaginal dryness~     while on anti-estrogen treatment could benefit from either vaginal estrogen or from a~     vaginal moisturizer called Replens.~   "
82003|NCT01984125|"~     Although most US adolescents visit their primary care doctor, their immunization rates are~     low. Primary care practices from two networks, one in upstate New York as well as a national~     network of pediatric clinics were surveyed to ask what they thought was the best strategy to~     increase immunization rates. Point-of-care prompts (either by an electronic health record~     message or by a nurse) when an adolescent patient comes in for any type of visit and is due~     for a vaccine was chosen. This study will determine if these prompts will increase~     immunization rates after a 12-month intervention period.~   "
82004|NCT01984112|"~     The hypothesis of this study is to determine whether the technique of intramedullary locking~     nail presents clinical results comparable to the technique of locking plates, based on the~     Constant Score.~   "
82005|NCT01984099|"~     A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention~     of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform~     mole.~   "
82006|NCT01984086|"~     This is an open-label, two part, six period- cross over, randomised, single dose, single~     centre study in healthy subjects. This is the first clinical study for the UD-DPI. This~     study is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of~     salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus~     or MDI. For this reason four treatment doses consisting of three dose strength and two~     percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide~     preliminary PK variability estimates to allow for better sample size/precision calculations~     for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile~     that is comparable to either Diskus or MDI in the presence of the charcoal block.~   "
82007|NCT01984073|"~     The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN~     (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more~     efficiently. This is important because people with dyslipidemia have a problem with how they~     process fat, which raise the risk of heart disease.~   "
82008|NCT01984060|"~     The overall purpose of this research is to evaluate the effect of a home-based exercise~     program on physical function and to improve the health and quality of life for the~     HIV-infected older adult community.~   "
82009|NCT01984047|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a~     screening visit and if eligible and consenting, will attend to participate in the study~     within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing~     when each subject will receive a single intravenous dose of GSK3050002 or placebo, then~     remain in house under supervision until discharged on Day 3. Subjects will then return for 7~     outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be~     7-14 days following the last visit.~   "
82010|NCT01984034|"~     Background: The Portuguese National Health Directorate has issued clinical practice~     guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive~     therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in~     changing actual practice is unknown. The objectives will be to compare the effectiveness of~     educational outreach visits in the implementation of clinical guidelines in primary care in~     Portugal against usual implementation strategies and to conduct a cost-effectiveness~     analysis of this method.~      Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care,~     with a 1:1 allocation ratio. This study will assess the effect of educational outreach~     visits on physician compliance with prescription guidelines. The general study hypothesis is~     whether educational outreach visits are superior to usual implementation of guidelines~     regarding the reduction of inappropriate prescribing (compliance with prescription~     guidelines). All National Health Service primary care units in the Lisbon (Portugal) region~     will be invited to participate. Units will be eligible if they are using an Electronic~     Health Record to issue prescriptions and have at least four doctors willing to participate.~     Doctors in intervention units will receive three educational outreach visits (one for each~     guideline) during a six months period, while the control group doctors will be offered an~     unrelated group training session (on using the international classification for primary~     care). Intervention visits will be one on one 15 minutes discussions conducted by guideline~     authors or trained family physicians at the physician's workplace. There are two primary~     outcomes, measured at the physician's level. One is the proportion of COX-2 inhibitors~     prescribed within the entire NSAID class, in defined daily doses 18 months after the~     intervention. The other is the proportion of omeprazole within the entire proton pump~     inhibitors class, in defined daily doses at 18 months post-intervention. Prescription data~     will be collected from the regional pharmacy claims database.~   "
82170|NCT01981850|"~     PRM-151 is an investigational drug that is being developed for possible use in the treatment~     of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body~     that makes blood cells, is replaced by fibrosis, or excess scar tissue.~      The purpose of this study is to gather information on whether PRM-151 has an effect on the~     MF disease, whether it is safe in patients with MF, and how well it is tolerated.~   "
82011|NCT01984021|"~     The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain,~     cervical range of motion and electromyographic activity of the upper trapezius muscle in~     patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12~     healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each~     patient will receive two forms of treatment in random order: a single session of traditional~     acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week~     wash-out period will be respected between sessions. Surface electromyography will be used to~     determine motor control in the upper trapezius muscle before and after treatment. The~     outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0~     [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical~     range of motion. Linear regression analysis will be applied for each individual to~     investigate associations between the sEMG variables and force (excluding the sixth step).~     The slopes of the regression lines will be used to measure the sensitivity of the sEMG~     variables regarding changes in force. The Shapiro-Wilk test will be used to test the~     normality of the data distribution regarding RMS and MDF values in the third and sixth step~     of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to~     test differences between third and sixth contraction step. A mixed linear model will be used~     to analyze and compare the sEMG data during sustained contraction (five steps) between~     pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will~     demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius~     muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during~     the four evaluations will also be compared using a mixed linear model. The Statistical~     Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the~     statistical analysis, with the level of significance set to 5% (p < 0.05).~   "
82012|NCT01984008|"~     The primary objective of this study is to demonstrate that investigation medication~     (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with~     regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An~     additional objective of this study is to collect subject's response to the acceptability and~     tolerability about bowel preparation and safety information.~      After bowel preparation, independent evaluator who is blinded to subject's treatment will~     evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600~     eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation~     to 1 of 2 treatment groups: Bowklean or Klean-Prep with Dulcolax. Each subject's~     participation is expected to be maximally 4 weeks in study duration (up to 3-week screening~     period followed by one week post colonoscopy).~   "
82013|NCT01983995|"~     Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with~     breast cancer. These medications can cause side effects in some women, and occasionally they~     can be quite bothersome. We are doing a study to better understand the side effects of~     aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In~     particular, we are interested in pain and difficulty sleeping. This study is designed to~     assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the~     interplay of these side effects and their subsequent impact on daily activity. Each~     participant will fill out a series of questionnaires about pain, sleep quality, and fatigue~     and will also complete a sleep diary and wear an actigraphy watch for 10 days before~     starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more~     about these symptoms so we can better manage medication toxicity in the future.~   "
82014|NCT01983982|"~     Many breast cancer survivors report chronic pain that develops or worsens following~     chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In~     this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to~     pain. We are also investigating whether a patient's sensitivity to pain is related to how~     many symptoms she experiences during treatment.~   "
82015|NCT01983969|"~     The goal of this clinical research study is to find the highest tolerable dose of~     azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a~     stem cell transplant, and with or without rituximab. Researchers also want to learn about~     the safety and level of effectiveness of this combination.~   "
82016|NCT01983956|"~     It is assumed that an early palliative care structured by SENS (a systematic, problem-based~     assessment system) in addition to standard oncology care compared with standard oncology~     care alone relieves distress in patients with advanced cancer at the end of life.~      The primary objective of the trial is to determine the effectiveness of early palliative~     care intervention, structured by SENS (a systematic, problem-based assessment system) in~     addition to standard oncology care, compared with standard oncology care alone to relieve~     distress a) in patients with advanced cancer until death, and b) in caregivers. The~     secondary objectives are to determine whether the introduction of SENS improves quality of~     life, prolongs overall survival, ameliorates distress of caregivers, reduces health care~     costs and medical resource utilization (less aggressive treatment in the last weeks of~     life).~   "
82017|NCT01983943|"~     The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT),~     to determine if six month supplementation of olive oil can improve the health of the blood~     vessels and improve long term health of the heart and blood vessels, in patients requiring~     percutaneous coronary intervention (PCI).~   "
82018|NCT01983930|"~     The purpose of this pilot study is to test whether 6 months of supervised weekly Kundalini~     yoga classes and a brief daily meditation homework assignment can improve memory and~     thinking in older adults with mild memory complaints when compared to weekly classes of~     memory training with daily homework assignments.~   "
82019|NCT01983917|"~     Prospective study to evaluate whether or not an internet application to coordinate and~     record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical~     care team and 3. ophthalmology vision care team will decrease vision loss and blindness due~     to diabetic retinopathy. The aims will be measured through health psychology instruments to~     assess the effect of the application on management, motivation to control their disease, and~     commitment to comply with treatment. We will also measure objective health outcomes~     including Blood Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.~   "
82020|NCT01983904|"~     The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep~     brain stimulation (DBS) in patients with treatment resistant depression (TRD).~      The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to~     improvements in TRD patients, and specific neuroimaging biomarkers will correlate with~     response to DBS; the functional recovery will be enhanced with concurrent cognitive~     behavioural therapy (CBT).~   "
82171|NCT01981837|"~     The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and~     exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR)~     Cardiac Amyloidosis.~   "
82021|NCT01983891|"~     This is a pilot intervention study conducted in four food shelves in the Twin Cities area.~     The aims of the study are to improve nutritional outcomes and client skills and~     self-efficacy among a culturally diverse group of food shelf clients through a nutrition~     education and meal preparation program. This study will also identify opportunities to~     expand the supply of healthy and culturally relevant foods in food shelves. The goal is to~     inform a larger-scale intervention to improve the nutritional quality and cultural relevance~     of food shelf items as well as client outcomes. The primary outcome is participant change in~     Health Eating Index scores from pre-intervention to post-intervetion.~   "
82022|NCT01983878|"~     The purpose of this study is to evaluate progression-free survival in participants with~     gastric or gastroesophageal junction cancer who have had disease progression following~     first-line therapy who undergo treatment with ramucirumab.~   "
82023|NCT01983865|"~     This clinical validation study is aimed at establishing a birch pollen challenge in the~     Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a~     validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether~     the challenge is dose dependent and reproducible.~   "
82024|NCT01983852|"~     Background Children living with life-limiting conditions have always been part of the health~     care system. Although there have been dramatic improvements in medical care, hundreds of~     children continue to die annually. The field of paediatric palliative care (PPC) and~     end-of-life (EOL) care is based on the principle that an interdisciplinary team should care~     for patients and their families. However, evidence on how to provide optimal PPC and EOL~     care covering the needs of children and their families is scarce and lags substantially~     behind that in the adult world. Few is known on how EOL care - defined as the last four~     weeks of life in this study - is presently provided in the Swiss health setting. The~     presented study Paediatric End-of-LIfe CAre Needs in Switzerland [PELICAN]) covers~     paediatric EOL care and will contribute to a comprehensive understanding of EOL care in~     Switzerland by analysing retrospectively medical charts of children/young people between 0 -~     18 years who died in the years 2010 and 2011 in Switzerland. A survey instrument will be~     developed and pilot tested to assess the perspectives of families who have experienced the~     loss of a child. After the development pilot testing and adaptation of the instrument a~     survey with parents who lost a child in the years 2010 and 2011 will take place.~     Furthermore, the experiences and needs of health professionals working in the field of~     pediatric EOL will be explored.~   "
82025|NCT01983839|"~     At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the~     empirical treatment of severe community-acquired pneumonia (CAP). This study was designed to~     determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically~     for CAP. To accomplish this aim, we established a pharmacokinetic population model. This~     approach was adopted with the dual purpose of assessing the potential efficacy of the drug~     and performing Monte-Carlo simulations to characterize the maximal MICs for which~     recommended pharmacokinetic-pharmacodynamic (PK-PD) targets are obtained for pathogens~     commonly known to cause CAP.~   "
82026|NCT01983826|"~     The overarching question addressed in the current project is: Does dietary nitrate~     supplementation (8 weeks) improve physiological function in patients with peripheral~     arterial disease (PAD)? The investigators will specifically address whether dietary nitrate~     supplementation enhances blood vessel function, blood pressure regulation, and exercise~     capacity. The proposed project uses an array of clearly defined measurements which will~     allow investigators to quantify blood vessel function (vasodilator responsiveness and~     arterial stiffness), blood pressure (variability and responsiveness to stress), and~     functional capacity before and after 8 weeks of dietary supplementation.~   "
82027|NCT01983813|"~     The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service~     (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary~     care offices and whether it can improve the care delivered to patients at risk for~     developing cardiovascular disease. The study will be conducted in 12 medical practices in~     Iowa that are either a Federally Qualified Health Center or part of the IRENE practice-based~     research network.~   "
82028|NCT01983800|"~     Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our~     standard intravenous medications. This commonly leads to confusion, low blood pressure, slow~     wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay.~     Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This~     unique project is the first North American study looking at using volatiles for patients who~     need longer-term ICU sedation. This project has excellent potential at lowering these~     complications and improving quality of care, which will lower patient ICU stay and~     healthcare costs.~   "
82029|NCT01983787|"~     At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion~     with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in~     patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).~      It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood~     test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.~   "
82030|NCT01983774|"~     Gastroesophageal reflux disease is a common problem in cystic fibrosis (CF). It may lead to~     worsening lung function and more respiratory infections for a person with CF. This study~     will look at treating GERD with a medication, esopmeprazole. The medication stops stomach~     acid from being made. The study will see if there are fewer respiratory infections and~     improved lung function in patients with CF when taking esomeprazole.~   "
82049|NCT01983527|"~     Arthrographic distention of the shoulder joint is an increasingly popular treatment option~     in the management of patients with frozen shoulder. Most have included the intra-articular~     injection of a corticosteroid as part of the procedure, but it is not known if this is~     necessary. It is also not known whether arthrographic distention using steroid and saline is~     better than intra-articular steroid injection alone.~      The purpose of this study is to determine whether there is an additional benefit in the~     combination of arthrographic distention plus intra-articular corticosteroid injection~     compared to arthrographic distention or intra-articular corticosteroid injection alone.~   "
82236|NCT01980979|"~     The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult~     patients with congenital heart disease and pulmonary hypertension. Baseline and~     post-treatment cardiopulmonary exercise tests will be performed.~   "
82031|NCT01983761|"~     The goal of this clinical research study is to learn if it is safe and feasible to~     transplant patients with one of two units of cord blood that has been changed in the~     laboratory before it is given. Only patients with leukemia, lymphoma or myelodysplastic~     syndrome will be allowed on this study. The secondary goal is to obtain the preliminary~     efficacy outcome. Researchers also want to learn if using cord blood that has been changed~     can help to control the disease.~      One cord blood unit will not be changed before it is administered to you. The cord blood~     unit that will be altered will be changed to use sugar that is found in small amounts in~     blood cells. It plays a role in telling transplanted cells where they should go in the body.~     Adding more sugars to the cord blood cells in the laboratory helps the cord blood cells find~     their way to the bone marrow faster. This process is called fucosylation.~      Conditioning is the chemo and other medicines and will be given to patients to prepare to~     receive cord blood transplant cells. This prevents immune system from rejecting the cells.~     Conditioning will be started before the transplant.~      ATG is a protein that removes immune cells that cause damage to the body.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the~     cancer cells to die. This chemotherapy is also designed to block your body's ability to~     reject the donor's bone marrow cells.~      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer~     cells to die.~      MMF and tacrolimus are designed to block the donor cells from growing and spreading in a way~     that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue~     attacks the recipient's body). This may help to prevent GVHD.~      Rituximab is designed to attach to cancer cells, which may cause them to die.~      A Phase I study for treatment of patients (N=25) with hematologic malignancies and MDS who~     are candidates for dual-cord UCBT is ongoing at M.D. Anderson Cancer Center under an~     Investigator-initiated IND Application, E.J. Shpall, MD, PI. Since August, 2012, Preliminary~     results indicate that ASC-101 UCBT is well-tolerated and no ASC-101 related untoward adverse~     events have been observed. To date, the median time to neutrophil engraftment (N=9) is 15~     days, and the median time to platelet engraftment (N=9) is 33 days. The trial remains~     ongoing.~   "
82032|NCT01983748|"~     Patients suffering from uveal melanoma (typed positive for monosomy 3) will be vaccinated~     over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA.~      200 patients will be included. The Trial is an open multicenter Phase III Trial.~   "
82033|NCT01983735|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg~     and 5mg) in patients with Stage 2 hypertension.~   "
82034|NCT01983722|"~     Expanded access to Stiripentol for patients with Dravet Syndrome.~   "
82035|NCT01983709|"~     The objective of this study is to determine if systemically infused allogeneic bone marrow~     derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized~     adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators~     plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned~     prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to~     recipient DNA present in patients' explanted prostate specimens. This will be accomplished~     via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at~     engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.~   "
82036|NCT01983696|"~     To investigate the effect of low oxygen tension during in vitro culture in terms of embryo~     quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection~   "
82037|NCT01983683|"~     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin~     in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
82038|NCT01983670|"~     In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle~     firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in~     individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed~     movement. Based on the previous studies, ballistic goal-directed movements are controlled by~     a triphasic pattern of agonistic and antagonistic muscle activation. The origin of the EMG~     pattern is a central program, whereas the delayed onset of antagonistic muscle firing has~     been reported to be the cause of hypermetria. To develop a therapy method, the difference in~     temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts~     between healthy adults and individuals with SCA when performing rapid and slow goal-directed~     movements should be further investigated.~      Traditional rehabilitations of individuals with cerebellum lesion were limited to improve~     the functional performance of movement. Since the deficits of the goal-directed movement are~     at pre-movement programming, only feedforward training will be possible to re-establish an~     appropriate program.~      Previous showed that peripheral stimulation resulted in a facilitation of motor cortex. Our~     group also found that this facilitation in individuals with SCA was similar to the ones~     without SCA. Therefore, it is possible to adjust the control pattern of supraspinal~     excitability of agonist and antagonist busts of SCA patient with passively providing~     electrical stimulation contains normal control pattern of healthy human.~      The present study sought to investigate the difference in temporal pattern and intensity of~     supraspinal excitability of agonist and antagonist bursts between healthy adults and~     individuals with SCA when performing rapid and slow goal-directed movements.~   "
82039|NCT01983657|"~     The purpose of this study is to establish an efficient and economic treatment scheme by~     evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of~     similar injection after whole lung lavage , in patients with PAP.~   "
82040|NCT01983644|"~     Endovascular therapy is increasingly used for patients with moderate-to-severe acute~     ischemic stroke.This study will compare the efficacy and safety of RECO(a novel,~     self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by~     the large vessel occlusion.~   "
82050|NCT01983514|"~     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate~     lactation in breastfeeding women. The intranasal administration of OT has recently attracted~     attention as a potential novel treatment in several psychiatric disorders including autism.~     However, given the anatomy of the nasal cavity, the current design of nasal sprays would be~     expected to provide an inadequate delivery of medication to the areas of the nasal cavity~     where direct transport into the brain via the olfactory nerve could potentially occur.~     OptiNose has developed an intranasal delivery device that provides improved reproducibility~     of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity~     where the olfactory nerve innervates the nasal cavity.~      The primary objective of this study is to identify any differences between single dose 8 or~     24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose~     device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers.~     This will be measured in terms of brain activity as measured with functional magnetic~     resonance imaging (fMRI), performance on cognitive tests, and physiological markers.~   "
82051|NCT01983501|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended~     dose (RD) and to assess the safety and tolerability of ONT-380 combined with ado-trastuzumab~     emtansine (T-DM1) in patients with HER2+ breast cancer.~   "
82041|NCT01983631|"~     The Cerebellum contains ten percent of the total volume of the brain and receives brain,~     spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory~     afferent informations are also reported to be impaired in patients with cerebellum~     dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with~     spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar~     damage are usually agonist and antagonist muscle coordination problem. Past studies also~     found the regulation of reciprocal Ia inhibition was impaired in patients with~     spinaocerebellar ataxia. In chronic phase, weakness might be developed due to deconditioned.~     All deficits mentioned above might lead to a decrease functional ability. Therefore,~     increasing somato-sensory and vestibular input, normalizing the modulation of recriprocal~     inhibition, and improve muscle strength might be able to improve the functional abilities of~     individuals with SCA.~      Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that~     WBV training were able to improve muscle strength, balance control, and functional ability.~     However, there is no evidence showed that whether the whole body vibration training can~     affect the brain and spinal cord for the regulation of neural circuits. Whether also can~     affect for maximal voluntary contraction and improve central fatigue. No previous studies~     that whole body vibration training for SCA.~      Therefore, the purpose of this research was to investigate the intracortical facilitation~     and inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary~     contraction, interpolated twitch technique to compare the different between the SCA and~     health subject. Also to investigate the short term and long term effect of WBV.~   "
82042|NCT01983618|"~     Beachchair position is used by many orthopaedic surgeons for shoulder surgery. Most patients~     undergoing surgery in this position have no complications. However, reported cases of~     postoperative neurological deficits have highlighted the risk of cerebral and spinal cord~     ischemia. The etiology of such complications remains unclear. The most plausible explanation~     for these events would be intraoperative hypotension followed by cerebral hypoperfusion.~      General anesthesia is commonly used for shoulder surgery in conjunction with interscalene~     brachial plexus blockade. During the block, local anesthetic's spread is frequently observed~     leading to a block of sympathetic fibres. Since all nerves located in the head and neck area~     go through the stellate ganglion, its block will cause a sympathetic denervation and a~     decrease of the peripheral vascular resistance, thus increasing the circulation in cerebral~     blood vessels. In normal situations, there is a vasoconstriction of the cerebral blood~     vessels in response to a sympathetic stimulation and a vasodilation if sympathetic fibres~     are blocked.~      Transcranial Doppler (TCD) is a non-invasive examination that provides a reliable evaluation~     of intracranial blood flow in real-time. It can help to detect sudden changes in perfusion~     and identify potential embolic events. Some studies using TCD have shown an increased~     ipsilateral cerebral blood flow (CBF) secondary to a reduced vascular tone associated with a~     stellate ganglion block. Others have shown a reduction of contralateral CBF that could~     theoretically increase the risk of ischemia in the affected area.~      This study will assess the role of interscalene nerve blockade in the protection of cerebral~     ischemia and preservation of cerebral autoregulation. This study will also aim to identify~     changes in contralateral CBF.~      The investigators hypothesize that:~        1. Interscalene nerve block will increase CBF~        2. Interscalene nerve block will not decrease contralateral CBF~        3. Cerebral autoregulation will be preserved under general anesthesia in conjunction with~          an interscalene nerve block in this setting.~   "
82043|NCT01983605|"~     Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the~     left atrial appendage in 100 patients.~   "
82044|NCT01983592|"~     Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients~     and there are very few conventional therapies which can address the symptom of fatigue in~     patients who are undergoing cancer treatment.~      This study will be testing whether the administration of a complementary therapy~     (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and~     whether this treatment can lessen the fatigue symptoms of adults. The study will also test~     whether the n-of-1 study design is feasible in this population.~   "
82045|NCT01983579|"~     This is a prospective, open label study assessing the 24-hour IOP patterns using TF in~     patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related~     macular degeneration). The study will be proposed to patients with AMD and patients with AMD~     and concomitant open angle glaucoma (OAG).~      The study will be conducted in two stages. In both stages, patients will remain ambulatory~     and will be encouraged to follow a schedule as close to their usual lifestyle as possible,~     with the exception of particular activities such as caffeine intake, playing wind~     instruments, yoga and strenuous exercise. A patient diary will be distributed for the~     capture of patient activities during the TF pattern recording. Upon completion of each~     session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination~     will be conducted.~      In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal~     range and no concomitant glaucoma will be recruited. After having signed and dated the~     patient informed consent form, patients will undergo an initial ophthalmic examination. One~     eye will be selected for the study. If both eyes are eligible, the study eye will be~     selected in random manner.~      All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at~     monthly interval. In the first session (S1) anti-VEGF injection will be carried out~     according to the study center standard protocol. For the second 24-hour TF recording session~     (S2), patients will be randomly distributed into three groups. Group A, consisting of 5~     patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared~     to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy~     occlusion after injection as compared to S1. Finally, group C, including 10 patients, will~     receive anti-VEGF in a different dose (injection volume) as compared to S1. The~     randomization ratio between groups A, B and C is 1:1:2.~      The overall study duration for an eligible patient in the first stage of this study is~     limited to 5 weeks.~      If in the first stage of this study an injection protocol is identified that provokes~     significantly lesser elevation on the TF pattern, the alternative injection protocol will be~     evaluated against the current standard protocol. For the second stage, 30 patients of whom~     15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited.~     After giving informed consent and confirmation of eligibility, all patients will receive two~     24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF~     injection according to the standard and alternative protocol will be carried out in random~     sequence.~      The overall study duration for a patient in the second stage of the study is limited to 5~     weeks.~      The study has been planned to recruit 20 eligible patients in the first stage within 12~     weeks from the date of initiation. The second stage will recruit 30 patients within 16~     weeks. Hence the overall study duration from the first patient accrued into the study until~     last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of~     study completion, a preliminary statistical report on the primary efficacy endpoint is~     foreseen within 2 weeks thereafter.~   "
82046|NCT01983566|"~     The purpose of this trial is to investigate the effect of food with different fat content~     and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative~     bioavailability of deleobuvir.~   "
82047|NCT01983553|"~     The purpose of this study is to conduct a passive surveillance of hospitalized dengue cases~     in subjects who participated in study CYD23 (NCT00842530).~      The Objectives are:~        -  To describe the incidence of virologically-confirmed hospitalized dengue cases.~        -  To characterize hospitalized dengue cases.~        -  To evaluate the occurrence of related and fatal serious adverse events (SAEs).~   "
82048|NCT01983540|"~     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)~     and booster vaccination in Study A3L27 (NCT01444781).~      Study Objective:~        -  To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a~          3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7)~          +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of~          age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix~          hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.~      Observational Objectives:~        -  To describe the long-term antibody persistence by group and by stratification on the~          age at inclusion of the A3L27 booster study.~        -  To describe the effect of one additional oral dose of stand alone poliovirus isotypes~          1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes~          (4 vs 5 doses of poliovirus administered).~   "
82053|NCT01983475|"~     Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and~     dramatic. After depletion of bone mass and the loss of architectural integrity, it may be~     difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative~     new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal~     osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related~     event to a greater extent than that with bisphosphonate administration. In persons with~     complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the~     knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL~     therapy appears to be more potent than bisphosphonates in animal models of bone loss due to~     immobilization, suggesting that treatment with denosumab may prove to be an efficacious~     therapy for persons with acute SCI to preserve bone mass and strength.~   "
82054|NCT01983462|"~     The purpose of the study is to test the effects of: 1) blocking sympathetic nerve activity~     with a drug called clonidine, and 2) by blocking a kidney protein called renin, and on blood~     vessel function and muscle nerve activity in adults who are obese and have high blood~     pressure.~      Years 1 and 2: The 1st cohort of subjects will consist of 69 healthy young men and women age~     18-79 years who are obese, defined as a body mass index > or = to 30 kg/m2, who have~     untreated systolic hypertension (systolic blood pressure > or = to 130 - <180 mmHg- average~     of at least 3 measurements 2 min apart after 10 min seated resting position). These 69~     subjects will then be randomized to 3 treatment arms: clonidine (0.1 mg/day),~     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks in years 1 and 2. All tablets will be~     encapsulated by to look identical. Subjects will randomly (1:1:1) receive one of the~     following combinations in a double-blind, placebo-controlled design:~        1. Oral clonidine (0.1 mg twice/day)~        2. Oral hydrochlorothiazide (12.5 mg twice/day)~        3. Oral placebo~      In addition to 69 healthy young men and women, we will also enroll 15 obese adults with~     'normal/optimal' systolic blood pressure (<120mmHg) who will undergo baseline testing only~     (Visits 1, 2 and 3).~      Years 3 and 4: A 2nd cohort of subjects (n=42) will be randomized to aliskiren (150 mg/day),~     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks. All tablets will be encapsulated to~     look identical. Subjects will receive one of the following in a randomized, double-blind,~     placebo-controlled design:~        1. Oral Aliskiren(150 mg/day- once per day)~        2. Oral Hydrochlorothiazide (12.5 mg twice/day)~        3. Oral placebo~   "
82055|NCT01983449|"~     To assess the safety and effectiveness of adventitial deposition of the Study Drug in~     reducing inflammation and restenosis in patients with clinical evidence of claudication or~     critical limb ischemia and an angiographically significant lesion in the superficial femoral~     and/or popliteal arteries.~      Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute~     contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel~     treatment length.~   "
82056|NCT01983436|"~     Orthognathic surgery aims to standardize position of the maxilla and the mandible and~     therefore chewing, breathing, phonation and swallowing functions. In postoperative, several~     physical and functional consequences are observed in patients: transient edema of the face,~     maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain~     and sensory disturbances (labial or/and chin paresthesias).~      Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease~     of postoperative edema, improved postoperative comfort and mental well-being.~      The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic~     drainage to reduce postoperative edema.~   "
82057|NCT01983423|"~     Animal and clinical studies have suggested that local tissue trauma can promote the process~     of an embryo implanting in the uterine cavity. The clinical studies have been performed in~     patients with a history of previously failed treatments using in vitro fertilization; a~     process of stimulating many eggs from a women and removing them from the body, to allow~     fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced~     into the uterine cavity.~      This study questions whether endometrial biopsy (placing a small straw like catheter through~     the cervix and into the uterine cavity to take a sample of tissue via suction into the bore~     of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will~     improve pregnancy outcome for patients in the first or second cycle of treatment. The~     hypothesis is that endometrial biopsy will improve pregnancy outcome.~      The study is a randomized multicentre study involving 3 Canadian fertility centres.~   "
82058|NCT01983319|"~     The aim of this study is to determine whether noninvasive brain stimulation in form of~     active transcranial direct current stimulation (tDCS) combined with constraint induced~     movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined~     with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA~     activity more than 3 months after stroke and its importance for effect of tDCS and CIMT~     combined with tDCS.~   "
82059|NCT01983306|"~     The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333~     doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain~     taking opioids.~   "
82060|NCT01983293|"~     The purpose of this study is to analyze the effect of left ventricular (LV) lead pacing~     location in the non-left bundle branch block (NLBBB)heart failure (HF) patient population.~     The LV lead pacing location will be guided by either the pacing site with the largest amount~     of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of~     care implant approach.~   "
82061|NCT01983280|"~     Adequate sleep is an important aspect of any healing process, and because it is known that~     children recovering from burns suffer long term sleep disruptions, the investigators believe~     that Healing Touch may improve the quality and quantity of sleep in the pediatric burn~     population.~   "
82062|NCT01983267|"~     Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although~     most Western countries have outlawed the use of cannabis according to the UN Convention of~     Psychotropic Substances, an increasing number of states in the USA, Canada and several~     European countries allow the medicinal use of cannabis subject to a doctor's recommendation.~     In oncology, the beneficial effects of treatment with the plant or treatment with medicine~     produced from its components are related to symptoms of the disease: pain, nausea and~     vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the~     efficacy of cannabis for these indications. In Israel, according to Ministry of Health~     regulations, permission to use medicinal cannabis for oncology patients can be given for two~     indications: to relieve disease-related symptoms in advanced disease or during chemotherapy~     treatment to reduce side effects. The indications are very wide and allow a great deal of~     freedom for the physician's decisions, but also cause high demands for cannabis from~     patients.~      The cannabis plant and the synthetic drugs based on the plant are considered to be medically~     safe. Most of the adverse effects are related to the fact that the plant and the drugs are~     psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating,~     disturbances in thinking, memory loss, and loss of coordination.~      Recently, we published the results of a prospective, observational study evaluating the~     medical necessity for medicinal cannabis treatment in cancer patients on supportive or~     palliative care. No significant side effects, except for memory lessening in patients with~     prolonged cannabis use (p=0.002), were noted.~      Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that~     patients may experience during or after chemotherapy. Memory loss and lack of concentration~     and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of~     significant concern to patients and has become a major quality-of-life issue for survivors,~     with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis~     use on cognitive functions of oncology patients has never been tested. Theoretically, the~     combination of chemotherapy and cannabis can cause severe reduction in cognitive functions~     in additive or synergistic ways. However, this hypothesis, too, has never been tested,~     although the number of patients using cannabis during chemotherapy treatments in Israel and~     in other Western countries is growing.~      Goals of current research: The main goal of the study is to evaluate prospectively the level~     of reduction in cognitive function of cancer patients who are on active oncology treatments~     and use cannabis, comparing to a group of patients without cannabis treatment. The second~     goal is to identify high-risk groups for cognitive impairment due to cannabis use.~      Patients and Methods: The study will be comprised of a cannabis user group that will include~     patients who will come for guidance sessions before being issued with a cannabis license and~     a control group of patients on active oncology treatments, meeting the same inclusion and~     exclusion criteria (except for cannabis use), and willing to complete the same pack of~     questionnaires and cognitive tests at the same three time points. All patients will sign an~     informed consent form. The study includes questionnaires on quality of life (EORTC-Q30),~     anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital~     Finger Tapping) administered by the nurses who give guidance on cannabis according to the~     patient's language (Hebrew, Russian or Arabic). The nurses will have a short guidance course~     on how to do cognitive tests and a monthly meeting with a neuropsychologist to test the~     quality of the cognitive tests. The questionnaires and cognitive tests will be done on the~     day of entering the study (T0) and after 3 (T3) and 6 months (T6). The patients will be~     asked not to use cannabis in the 12 hours before the interviews after 3 and 6 months.~      Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test~     (half the SD for the normal population) between two groups after three months of cannabis~     use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild~     cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84~     patients). Due to an expected drop-out of 20%, the number of patients to be included in the~     study is 101.~   "
82063|NCT01983254|"~     Patients who receive life support in intensive care units commonly suffer from persistent~     depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We~     are trying to learn which is a better way to manage this distress: a telephone-based~     adaptive coping skills training program or an educational program.~   "
82259|NCT01980680|"~     After hCG trigger a large amount of exogenous progesterone is used for luteal phase support~     in many countries until 10th week of gestation. Instead we suggest the use of two small~     doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting~     the endogenous progesterone production from the corpora lutea (CL).~   "
82064|NCT01983241|"~     This is a multi-center, randomized, placebo-controlled, double blind clinical study to~     assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo~     for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main~     measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg~     administered weekly by IV infusion for 156 weeks. The study consists of a Screening Phase, a~     156-week Treatment Phase, and an End of Study Visit at Week 160.~   "
82065|NCT01983228|"~     The long term goal is to improve the quality and equity of chronic pain treatment among VA~     patients. The primary objective of this study is to improve pain outcomes among black VA~     patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and~     outcomes than their white counterparts. The work proposed is expected to result in a~     non-pharmacological intervention, delivered by telephone, designed to reduce pain and~     improve functioning among black patients with MSK pain, by promoting walking. This~     intervention is specifically designed to address factors that contribute to MSK pain among~     black Veterans; however, the investigators expect that it will also benefit non-black~     Veterans. The proposed research is innovative, in its use of proactive outreach and recent~     advances in self-regulation strategies (such as Action Planning) to help black Veterans~     overcome psychological, environmental, utilization-related, and provider-related barriers~     that contribute to pain.~   "
82066|NCT01983215|"~     The purpose of the study is to determine the effects of Prevena therapy on decreasing groin~     surgical site infections in patients who are obese and /or diabetic having vascular surgery.~   "
82067|NCT01983202|"~     The aim of the study is to investigate body composition in newborn children of women with~     PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.~   "
82068|NCT01983189|"~     This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS)~     for subjects with autism spectrum disorders, specially targeting repetitive behaviors.~   "
82069|NCT01983176|"~     The aim of this study was to determine the histopathological results of parotid tumors and~     postoperative complications after partial superficial or total parotidectomy with facial~     nerve dissection and superficial musculoaponeurotic system reconstruction.~   "
82070|NCT01983163|"~     In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to~     ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure~     reduction from baseline seizure frequency at 6 months~   "
82071|NCT01983150|"~     The primary aim of this study will be to determine the effectiveness of a smartphone~     delivered app for young adult smokers on quitting smoking.~   "
82072|NCT01983137|"~     This non-interventional, observational study evaluates the efficacy of Targinact with regard~     to pain relief in daily clinical practice in Belgium compared to the previous analgesic~     treatment.~   "
82073|NCT01983124|"~     The purpose of this study is to evaluate the activity of Vemurafenib in combination with~     Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who~     recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile~     of prolonging treatment of this drugs combination will be assessed.~   "
82074|NCT01983111|"~     The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal~     system to tramadol/acetaminophen.~   "
82075|NCT01983098|"~     Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause~     of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately~     35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and~     III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated~     by computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen~     (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the~     chemotherapy. The management of treatment for metastatic CRC need the development of early~     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early~     chemotherapy resistance. In this prospective study, the investigators will compare the~     monitoring of circulating tumor DNA with the results of CT scan according the RECIST~     criteria and the blood level of CEA and CA 19-9. The investigators carried out a~     microfluidic digital polymerase-chain-reaction (PCR) assay to measure the specific somatic~     genomic alterations in plasma to identify the circulating tumor DNA.~   "
82076|NCT01983085|"~     This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating~     dressing on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects~     on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This~     160 patient, randomised, controlled clinical study will assess the ability of a simple 2~     part, NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor~     site wounds compared to standard of care.~   "
82077|NCT01983072|"~     The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota~     balance. Together, the prebiotic solution in combination with the probiotic is expected to~     harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates~     and to allow a greater diversity of Bifidobacteria species in comparison with a formula~     non-supplemented with pre and probiotics.~   "
82078|NCT01983059|"~     The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at~     collecting clinical data, patient reported outcomes and biological samples of all patients~     who have been newly and previously diagnosed with liver venous thrombosis in one of the~     participating hospitals in-and out-patients clinics of the participating centers in~     Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are~     currently being treated in one of the participating centers, will be asked to participate in~     the study.~   "
82091|NCT01982890|"~     The Investigators have established a cohort of patients with recent-onset inflammatory~     arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to~     define novel biomarkers of poor outcomes. We want to study telomere length and T-cell~     Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.~      This cohort of normal controls was established to be able to define the stability over short~     periods of time of telomere length and TREC numbers in normal individuals, in order to~     compare with arthritis patients.~   "
82092|NCT01982877|"~     The purpose of this study is to test the effectiveness of a multi-faceted communication~     intervention for family members of critically ill patients to reduce the family members'~     long-term symptoms of depression and anxiety.~   "
82079|NCT01983046|"~     Gut microbiota is being increasingly recognized as an important factor in fat distribution,~     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota~     could play an important role in the development of obesity and type 2 diabetes mellitus. The~     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by~     microbial fermentation of fiber, is still controversial. One study found that an increase in~     the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain.~     In contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in~     SCFA formation, had beneficial effects on body weight control and insulin sensitivity. Of~     note, a study showed that butyrate supplementation in mice prevented diet-induced obesity~     and insulin resistance. At the present time, our understanding of the effects of SCFA on~     human metabolism (in gut or systemically) is still limited. Yet, in light of the health~     claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human~     SCFA metabolism and its interaction with the microbiome is of pivotal importance. We~     hypothesize that the differential availability of SCFA impacts human metabolism differently.~     To determine whether rectal administration of SCFA is a good model for studying the~     metabolic effects of SCFA we first have performed a pilot study (METC 11-3-079). In this~     pilot study we have determined if rectal administration of sodium acetate has the same~     effects on substrate and energy metabolism compared to proximal administration. Our results~     indicate that the primary outcome parameter fat oxidation was significantly changed during~     post-absorptive conditions, when sodium acetate in a concentration of 180mM was administered~     in the distal part of the colon. In contrast, no effect on energy expenditure or substrate~     oxidation was seen when sodium acetate was administered in the proximal colon. Consequently,~     the distal part of the colon seems to be a good model to determine effects of gut-derived~     SCFA on the human substrate and energy metabolism. Therefore, we will administer in this~     study the SCFA rectally by using enemas. We will administer different combinations of SCFA~     to healthy, overweight male volunteers and examine effects on metabolism. This study is an~     important part of a Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide~     more insight in how increased availability of a beneficial SCFA mixture might serve as a~     basis for rational nutritional strategies in the prevention and treatment of obesity and~     type 2 diabetes mellitus. To obtain rational nutritional strategies, a next step in this~     TIFN project will be focusing on dietary ingredients modulating intestinal microbiota and~     subsequent SCFA production.~   "
82080|NCT01983033|"~     Repetitive negative thinking (RNT) plays an important role in different psychiatric~     disorders, such as depressive and anxiety disorders, complicated grief, anorexia nervosa.~     RNT is seen as a vulnerability factor in the onset, duration, severity and relapse of those~     disorders. Although there is a lot of theoretical research, it is un- known if a training~     program addressing RNT has a surplus effect on Treatment as Usual (TAU). Our hypothesis is~     that a training intervention will show a significant effect on declined RNT activity,~     reduced identification with worrying/rumination, and reduced scores on metacognitions~     questionnaires, when compared to TAU (medication, psychotherapy or a combination of both~     treatments). Further we expect that this effect on RNT will not be temporary and the~     beneficial effects will remain present over a longer time (6 months). Our third hypothesis~     claims that reduced RNT will have an effect on Quality of Life, self-esteem and depressive~     and anxiety scores ( as measured by BDI-II and STAI). Fourth hypothesis concerns the effect~     of the training in the functioning on a neurobiological level. Here we expect that in~     ruminative patients beneficial effects of RNT will increase top-down prefrontal~     (dorsolateral) cortical control over an overactive bottom-up limbic system. To examine these~     neurobiological effects, we apply a multimodal approach where we combine resting state fMRI,~     structural MRI such as diffuse tensor imaging (DTI), anterior spin labelling (ASL). Further,~     in our department we developed an audio critique task where participants hear different~     kinds of critique amongst some of negative valence which will be especially problematic for~     ruminative patients reflecting difficulties and differences these top-down/bottom-up~     processes when compared to a healthy control group at baseline. Further, we hypothesize that~     only when RNT is successful these neuronal processes will normalize. We do not expect~     changes in the waiting list group.~      To examine these clinical and neuronal effects, people suffering from GAD and/or depression~     will be allocated by randomisation to an active treatment condition (ATC) and a waiting list~     control group WLC). All the participants will be patients treated by general practitioner,~     psychologist or psychiatrist. Training exists of 8 sessions in group (max 12 participants)~     on a weekly basis, except for the last session, which takes place after one month). During~     the training people will get information on RNT, they will be trained in focusing their~     attention, will receive some basic ideas about becoming aware of dysfunctional thinking and~     learn coping strategies such as stimulus control and engaging in activity.~      Measurement will take place before and after treatment for the ATC. The WLC will be measured~     at the start of the ATC and after 12 weeks. Measurement takes place by means of~     questionnaires and fMRI. During the fMRI people will undergo a resting state paradigm and~     some tasks triggering RNT. After three and 6 months, at the time interval of 3 and 6 months,~     participants will be evaluated again on RNT by means of questionnaires.~      At the end of the training, after 8th session, two participants per run will be asked to~     cooperate in a qualitative in-depth interview. We are interested in linking results with the~     training with some factors such as quantity of sessions, degree of active participation in~     between sessions. We are also interested in defining which interventions are perceived as~     most useful and if there is a link between disorder and the usefulness of some~     interventions.~   "
82081|NCT01983020|"~     This study has been designed as a controlled clinical trial to evaluate the efficacy of~     brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion~     when added to conventional opioid therapy following major spine surgery, as well as to~     evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of~     performing routine intraoperative neurophysiology during spine surgery in adults and~     determine whether this infusion protocol is compatible with intraoperative neurophysiology~     on spine surgery patients. If one or more of the approaches is confirmed as efficacious and~     safe, it could have a significant impact on the routine management of postoperative pain in~     this context.~   "
82082|NCT01983007|"~     Endothelial dysfunction precedes the development of cardiovascular disease and it is common~     in patients with diabetes mellitus. The aim of this study is to identify the effect of two~     different physical training programs, using ultrasound techniques, on the endothelial~     function of patients with type 2 DM.~   "
82083|NCT01982994|"~     Observational research has linked physical activity with faster recovery, improved quality~     of life, and greater survival; however, little is known about the effects of physical~     activity in pre-operative, peri-operative, or post-operative treatment contexts and there is~     a need for interventions to improve patient outcomes across the cancer treatment continuum.~     Three propositions derived from basic research, epidemiological evidence, and clinical~     practice informed our intervention development efforts: (1) Patient outcomes will be~     enhanced by interventions that increase physical activity (i.e., standing, walking) across~     the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2)~     Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy~     expenditure) will enhance patient outcomes both by increasing physical activity and by~     stimulating additional adaptive physiological responses to reduced sedentary time (responses~     which are independent of physical activity-induced responses). (3) Patients with~     gastrointestinal cancers often suffer functional limitations that limit their independence~     and their health behaviors are strongly influenced by the family environment so~     interventions that engage caregivers (e.g., spouses) will be more effective than those that~     target patients/survivors alone.~   "
82084|NCT01982981|"~     Nowadays, it is common to ingest beverages other than plain water, which range from flavored~     with a low energy input to others of high input. In Mexico, flavored beverage ingestion is~     believed to be displacing plain water; this phenomenon is raising concern in the health~     sector, due to the relation between flavored beverage intake and the increase in obesity~     and, consequently, chronic diseases.~      Up until now, there is no instrument available to characterize the perception of the Mexican~     population's well-being, beliefs and knowledge regarding plain water ingestion, nor is there~     an instrument capable of quantifying the daily water ingestion.~      The purpose of this study is design and validate a questionnaire to identify and evaluate~     the perception of well-being (PWBQ) related to plain water consumption in a sample of adult~     men and women of the city of Cuernavaca.~   "
82085|NCT01982968|"~     This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in~     subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER)~     will slow the decline of forced vital capacity (FVC) over 48 weeks.~   "
82086|NCT01982955|"~     This is a multi-center, open-label, randomized, Phase 1b/2 trial to determine the~     recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free~     survival (PFS) of Tepotinib when used in combination with gefitinib in subjects with T790M~     negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC)~     harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to~     Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy.~   "
82087|NCT01982942|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study~     designed to evaluate the safety, tolerability and activity of ibudilast administered twice~     daily over a 96 week period in subjects with primary or secondary progressive multiple~     sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or~     who are receiving either glatiramer acetate (GA) or interferon beta (IFNβ-1a [Avonex, Rebif]~     or IFNβ-1b [Betaseron Etavia]) treatment. Study drug will be administered as an adjunct to~     glatiramer or beta interferon treatment. A total of 250 male and female subjects from 21 to~     65 years old, inclusive, are planned to be enrolled into two treatment groups. Randomization~     of subjects will be stratified by disease status (primary progressive multiple sclerosis or~     secondary progressive multiple sclerosis) and immunomodulating therapy status: current use~     of immunomodulating therapy or no current use of immunomodulating therapy.~      The study will consist of a screening phase (up to 30 days) followed by a treatment phase~     (96 weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening~     phase, subjects who continue to meet entry criteria will be randomly assigned to 1 of 2~     treatment groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study~     drug will be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the~     morning and evening).~   "
82093|NCT01982864|"~     Aminoglycosides are widely used for the treatment of Gram-negative bacilli and~     Staphylococcus aureus infections because of their effectiveness and low cost. Nevertheless,~     many aspects of their optimal use in hemodialysis patients remain unsolved and little is~     known about their pharmacokinetics in this context. The current practice for prescribing~     aminoglycosides to these particular patients consists in giving after each hemodialysis~     session about half the dose usually given to patients with normal renal function.~      However, theoretical considerations and emerging clinical data suggest that this may not be~     the most beneficial dosing regimen as efficient peak concentrations are often not attained~     and the occurrence of ototoxicity and nephrotoxicity is still frequent.~   "
82094|NCT01982851|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first stage of labor in nulliparous women scheduled for an induction of labor, with whom~     analgesia is maintained with a combined spinal epidural (CSE) technique versus an epidural~     de novo technique. The investigators hypothesize that the duration of the first stage of~     labor will be no different in nulliparous patients who receive either intrathecal fentanyl~     or intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration~     of the first stage of labor will be shorter in parturients who receive intrathecal analgesia~     (as part of a CSE technique) compared to those who receive an epidural de novo technique~     with fentanyl and bupivacaine.~   "
82095|NCT01982838|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first stage of labor in nulliparous women in spontaneous labor with whom analgesia is~     maintained with a combined spinal epidural (CSE) technique versus nulliparous women in~     spontaneous labor with whom an epidural de novo technique is utilized. The investigators~     hypothesize that the duration of the first stage of labor will be no different in~     nulliparous patients who receive either intrathecal fentanyl or intrathecal fentanyl and~     bupivacaine, as part of a CSE technique. However, the duration of the first stage of labor~     will be shorter in parturients who receive intrathecal analgesia (as part of a CSE~     technique) compared to those who receive an epidural de novo technique with fentanyl and~     bupivacaine.~   "
82096|NCT01982825|"~     Tobacco use is the leading cause of cancer death in the U.S. Because smokers who quit by age~     30 have cancer death risk similar to non-smokers, promoting cessation early in life is~     critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged~     18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in~     the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is~     increasing, particularly among young adults and African Americans. Moreover, young smokers~     and nondaily smokers (half of young adult smokers), respectively, are less likely to seek~     help in quitting; thus, innovative strategies are needed to assist cessation early in life,~     particularly among those who may not be motivated to quit or seek help. Unfortunately, no~     research has focused on developing a cessation intervention that addresses a broad range of~     smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically~     diverse student populations. Web-based interventions offer promise in helping college~     students to quit, given high rates of Internet use and web capacity to provide tailored~     cessation messages. A novel approach to delivering cessation information via the web might~     be to address broader lifestyle issues and apply market research strategies to identify~     market segments of smokers (groups of people with similar interests, goals, values) in order~     to target and engage these groups more effectively. Applying this strategy to an online~     cessation intervention should enhance both intervention use and processing of intervention~     messages, leading to greater abstinence rates. The investigators aim to: (1) develop and~     refine a tailored web-based intervention for smoking cessation targeting college students~     with a range of smoking levels; (2) test the usability, acceptability, and feasibility of~     the intervention among college student smokers; and (3) determine the potential effect of~     the intervention on smoking cessation, smoking level, quit attempts, and contextual factors.~   "
82097|NCT01982812|"~     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%~     and leaving one third of survivors with long term neurologic and psychiatric sequelae.~     Seizures occur commonly with CM and are associated with an increased risk of death and~     neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral~     levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy~     studies aimed at improving seizure control and ultimately decreasing the neurologic~     morbidity of pediatric CM.~   "
82098|NCT01982799|"~     For patients with a toothache, is pain relief after root canal procedure improved using long~     acting local anesthetic and analgesics? The purpose of this clinical trial is the~     investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups,~     on post-operative endodontic pain.~   "
82099|NCT01982786|"~     This research is being done because investigators involved in this study would like to~     compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy~     boost to see which treatment is better and what the side effects of treatment are.~   "
82100|NCT01982773|"~     A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients~     expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or~     non-suicidal self harm. A Virtual Hope Box (VHB) takes the common hope box practice and~     uses smartphone features to enhance the experience. The rich multimedia features on a~     smartphone allow more varied options. Furthermore, these devices are already a common~     repository for user-generated and user-preferred media, which will allow for a highly~     personalized VHB that is highly portable and always available to a user in distress. We~     hypothesize that:~        1. Patients in the (VHB) intervention condition will demonstrate pre-post reductions in 1)~          severity of suicidal ideation 2) ability to cope with stressors and 3) increases in~          perceived reasons for living~        2. Patients in the intervention condition will demonstrate greater pre-post reductions in~          symptoms of suicidal ideation, ability to cope with stressors, and perceived reasons~          for living compared to patients in the (ETAU) control condition.~        3. Patients and clinicians will find VHB to be beneficial and its use readily integrated~          into practice.~   "
82101|NCT01982760|"~     This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce~     bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a~     drug used in patients with bleeding disorders. It works by activating molecules in the blood~     stream called platelets that promote clotting. In the study, participants who are have~     cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive~     medication. Photographs taken before and shortly after surgery will be evaluated for the~     amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are~     not eligible to participate.~   "
82102|NCT01982747|"~     MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin,~     kidneys and lungs. The dosage form of MGN1703 under investigation is an injection.~      The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of~     the heart in healthy subjects and to look at general safety.~   "
82103|NCT01982734|"~     Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous~     health-promoting activities. The oral bioavailability of curcumin is low due to its poor~     aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion.~     Therefore, we tested, in a randomized crossover study, simultaneous application of~     phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the~     absorption of curcumin into the body. Furthermore, we investigated age and sex differences~     in curcumin pharmacokinetics.~   "
82104|NCT01982721|"~     The investigators hypothesize that a new automatic prosthetic knee locking mechanism will~     improve gait characteristics during an induced controlled trip and reduce fear of falling.~   "
82105|NCT01982708|"~     The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen.~     Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are~     assessing the ability of a non invasive, optical device that is placed on a patients abdomen~     (much like an ultrasound transducer) to evaluate a patient with an acute abdominal~     presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel~     obstruction will be examined with the haptic device. Data will be collected by the device~     and later compared to the abdominal findings recorded from an examination conducted by the~     principle investigator who is a surgeon. The surgeon will not have acess to data collected~     by the haptic sensor and therefore it will have no impact on the decision making process in~     the care of the patient. The impact on the individual patient will require obtaining a~     consent to participate in the study, a few minutes to place the device gently on the abdomen~     and collect the sensor data. There is no direct benefit to the patient by participating in~     the study. The potential for such a study may be to develop the technology to have a device~     that non-medical staff can use to collect patient data and transmit that data to a~     healthcare provider at another location.~   "
82106|NCT01982695|"~     This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the~     treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be~     effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the~     onset and progression of left ventricle dysfunction in children with DMD. Multiple studies~     show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular~     dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved~     for patients in whom heart failure is not adequately treated or where side effects preclude~     the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug~     because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse.~     Considering that both skeletal and cardiac muscles are major contributors of the disability~     of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need~     consideration as the drug of choice for the cardiomyopathic DMD patient.~   "
82107|NCT01982682|"~     This phase II trial studies how well total-body irradiation, donor lymphocyte infusion, and~     cyclophosphamide before donor stem cell transplant works in treating patients with high-risk~     hematologic malignancies. Giving total-body irradiation, donor lymphocyte infusion, and~     chemotherapy before a donor stem cell transplant helps stop the growth of cancer and~     abnormal cells and helps stop the patient's immune system from rejecting the donor's stem~     cells. When certain stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells. Removing the T cells from the donor cells before transplant and giving~     tacrolimus and mycophenolate mofetil may stop this from happening.~   "
82108|NCT01982669|"~     Excess dietary salt intake is closely associated with the development of hypertension and~     cardiocerebral vascular diseases. Reduction in high salt intake significantly prevents~     hypertension and cardiocerebral events. Currently, few promising method is available to~     reduce salt intake in human. This study focus on examining the salty taste in~     population-level and exploring whether dietary factors can reduce salt intake through acting~     on salty taste.~   "
82109|NCT01982656|"~     This research study seeks to explore the effects of massage techniques on pain and anxiety~     relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to~     subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to~     decrease the overall medication use to treat pain and anxiety, and to determine the impact~     of massage on sleep duration, quality, and breathing. Our goal is to improve and promote~     comfort during the ICU stay as well as decrease the need for narcotic medication usage.~   "
82110|NCT01982643|"~     The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a~     combination of extended-release depot naltrexone plus extended-release bupropion as a~     potential pharmacotherapy for methamphetamine (MA) use disorder.~   "
82111|NCT01982630|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once~     daily compared to placebo and another diabetes drug in participants with Type 2 diabetes~     mellitus (T2DM).~      This study was modified by a protocol amendment to a 2-part trial to further test the safety~     and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between~     participants with T2DM and healthy participants. An additional cohort of T2DM participants~     and a cohort of non-diabetic obese participants have been added.~   "
82112|NCT01982617|"~     The investigators primary hypothesis was that recipients of the Motivational Interviewing~     intervention would be significantly more likely than those assigned to the Psychoeducation~     intervention to demonstrate increased readiness to quit smoking at the end of the~     intervention and to seek smoking cessation treatment in the one month period following the~     intervention. We also predicted that the Psychoeducation intervention would result in~     greater improvements in smoking knowledge.~   "
82113|NCT01982604|"~     A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD~     of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.~   "
82114|NCT01982591|"~     This research trial studies heavy metal exposure in predicting peripheral neuropathy in~     patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood~     and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy~     may help doctors find out whether side effects from chemotherapy are related to heavy metal~     exposure.~   "
82115|NCT01982578|"~     Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's~     disease (AD).~      A few years ago our group reported that genistein increased PPARg (peroxisome proliferator~     activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg~     dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of~     amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases~     the availability of the transcription factor, it can increase apoE, and also AB degradation.~      The main aim of this study is to determinate the effect of 60 mg BID of genistein~     administration, during 180 days, compared to placebo group, in AD patients.~   "
82116|NCT01982565|"~     This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating~     dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the~     body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140~     patient, randomised, controlled clinical study will assess the ability of a simple 2 part,~     NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic~     DFUs compared to standard of care.~   "
82117|NCT01982552|"~     The purpose of this study is to document quality of life, patient satisfaction, effect on~     itching, and control of psoriasis vulgaris associated with use of~     calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension 0.005% / 0.064% for~     treatment of plaque psoriasis under real-life conditions.~   "
82118|NCT01982539|"~     As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is~     to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.~   "
82119|NCT01982526|"~     Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti~     mullerian hormone is recent marker for ovarian reserve. The investigators are searching~     ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma~     patient who are operated for their cysts.~   "
82120|NCT01982513|"~     Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome.~     Because of its rare occurrence and ethical issues this topic is not very well studied and~     many questions pertaining to maternal resuscitation remain unanswered. One of the~     challenging aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal~     positioning during chest compressions. International societies have made recommendations~     regarding management of pregnant patients during cardiac arrest. They advocate the use of~     left lateral position with 30 degrees tilt or manual uterine displacement. However these~     recommendations are not based on high level of evidence. Ultrasound has been used to~     visualize the change in diameter of great vessels to determine the volume status or adequacy~     of blood circulation of these patients. This approach can be used to study the adequacy of~     blood circulation of pregnant patients in different positions. The objective of this study~     is to compare the change in Inferior vena cava diameter obtained with pregnant women in~     either the left lateral tilt or in the supine position with a manual uterine displacement,~     compared to the left lateral position and the supine position.~      Our hypothesis is that the inferior vena cava diameter obtained in the supine position with~     manual left uterine displacement would be larger as compared to that obtained with women~     positioned with a 30-degree tilt.~   "
82121|NCT01982500|"~     Investigators propose to assess,the safety and tolerability profile (number of participants~     with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line~     treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal~     carcinoma~   "
82122|NCT01982487|"~     This partially randomized phase I/IIb trial studies the side effects vaccine therapy and~     indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide~     (INCB024360) and to see how well they work in treating patients with epithelial ovarian,~     fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from~     gene-modified virus may help the body build an effective immune response to kill tumor~     cells. IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be~     an effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.~   "
82123|NCT01982474|"~     The purpose of this study is to determine safety of allergy immunotherapy lymph node~     injections for grass pollen allergies.~   "
82124|NCT01982461|"~     The objective of this trial is to assess the efficacy of reducing plasma low-density~     lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg~     and Crestor 10mg F.C. Tablets in hypercholesterolemia population.~   "
82125|NCT01982448|"~     This research study is evaluating how well triple negative breast cancer responds to~     preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research~     test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative~     treatment.~   "
82126|NCT01982435|"~     The primary objective of the study is to assess the ocular and systemic adverse events of~     ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with~     intravitreal bevacizumab (Avastin).~   "
82127|NCT01982422|"~     This is a study evaluating the relationship between prenatal nutrition and neural~     development in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD).~     We are hypothesizing that women randomized to a whole food, nutrient-dense diet during their~     3rd trimester of pregnancy will have infants with more advanced neural development as~     compared to infants born to mothers receiving standard-of-care treatment.~   "
82128|NCT01982409|"~     The purpose of this study is to observe the persistence of protection, duration of~     protection, safety and breakthrough infection rates afforded by live attenuated varicella~     vaccine in children over a 5-year period.~   "
82129|NCT01982396|"~     Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC~     (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD)~     with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of~     combination antiretroviral therapy.~   "
82130|NCT01982383|"~     The investigators hypothesis is that using the micropulse laser in patient with Central~     Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in~     significantly minimizing visual recovery time from this disease as well as potentially~     preventing recurrences.~   "
82132|NCT01982344|"~     To compare the effect of mini-exchange-room and usual care on physical activity and quality~     of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total~     of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically~     stable and regularly followed up. The one group perform traditional PD procedure (G1), and~     the other group will utilize disposable mini-exchange-room group (G2). Two groups will be~     followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity~     and quality of life will also be collected for all subjects at the 3rd and 6th month. During~     the study period, peritonitis episode, acute comorbidity and hospitalization will be~     recorded. The change of physical activity, quality of life and peritonitis rate will be~     compared between the two groups.~   "
82133|NCT01982331|"~     This is a phase I study to evaluate the safety of a vaccine to protect against influenza~     viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of~     vaccine or placebo one month apart.~   "
82134|NCT01982318|"~     The objective of this study is to assess the efficacy and safety of VitroGro® combined with~     standard care in the treatment of Venous Leg Ulcers (VLUs) compared to Placebo with standard~     care over the course of the 8-week treatment phase.~   "
82135|NCT01982305|"~     The purpose of this study is to determine whether an ultrasound-guided nerve block simulator~     is effective for the training of the axillary block technique.~   "
82136|NCT01982292|"~     The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic~     heart failure.~   "
82137|NCT01982279|"~     Objectives: The aims were to measure one year change in caloric compensation (CC) and eating~     in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating~     context and to link these change with individual characteristics (adiposity, age, gender)~     and maternal feeding practices.~      Three series of measurements of caloric compensation (CC) and eating in the absence of~     hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each~     serie of measurement was composed of three consecutive weeks an identical lunch was served~     in four preschool canteens reaching 236 children. The first lunch was a control session. For~     the CC situation (week 2), thirty minutes before the lunch children were offered a preload~     (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to~     palatable foods (430 kcal). Food intake was measured at the individual level. Maternal~     eating behaviour and feeding practices were measured by questionnaires. Child's height and~     weight were measured by a medical doctor.~   "
82138|NCT01982266|"~     This is a prospective, multicenter, single arm feasibility study of the safety and~     performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require~     cartilage replacement.~   "
82139|NCT01982253|"~     To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once~     daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately~     controlled on diet and exercise alone.~   "
82140|NCT01982240|"~     The purpose of this study is to confirm that the investigational medication, plecanatide, is~     safe and effective in treating chronic idiopathic constipation.~   "
82141|NCT01982227|"~     Between 30% and 40% of patients with colorectal cancer develop metastatic disease~     intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy~     but requires resection of all lesions larger than 2mm.~      Indocyanine green has an affinity for tumor tissues and the interest of its use has been~     demonstrated for the detection of sentinel lymph node and some liver surgeries.~      The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never~     been evaluated.~      This study aims to evaluate the diagnostic performance of fluorescence in the detection of~     malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological~     analysis.~   "
82142|NCT01982214|"~     A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged~     55-75 years, over a 18-month period. The group 1 received a physical intervention,~     consisting of whole body vibration (WBV) over 12 months followed by training arrest during 6~     months. The group 2 served as sedentary control. WBV training is performed 2 or 3 times per~     week, with each session lasting 20 minutes. The training included light squats at 35-50 Hz~     and ended up by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural~     evaluations will be performed at the beginning, 6, 12 and 18 months in each group with~     evaluation of bone micro-architectural trabecular and cortical compartments, at the weight~     bearing tibia and the non weight bearing radius.~      The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone~     exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral~     quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA~     at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and~     trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone~     markers will be analyzed longitudinally. The secondary aim is to assess muscle performance~     and proprioception. Finally will be assessed markers of cartilage degradation and synthesis,~     no study has been published on this tissue.~   "
82143|NCT01982201|"~     This study will assess the potential effects of calcium carbonate and aluminum/magnesium~     hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of~     lesinurad in healthy, adult male subjects.~   "
82144|NCT01982188|"~     This study was designed to evaluate urinary function before and one year after single~     incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more~     minimally-invasive, single incision sling would provide a similar subjective success rates~     as those of retropubic and trans-obturator slings.~   "
82145|NCT01982175|"~     This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and~     safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic~     leukemia.~   "
82146|NCT01982162|"~     Cross-sectional study to characterize cohorts of children with asthma and healthy controls~     in terms of clinical features, physiological measurements and non-invasive measurement of~     biomarkers and develop phenotype handprints for children with severe asthma~   "
82337|NCT01979666|"~     The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates~     induce peripheral vasodilation and may improve blood supply to the affected tissue.~      This study aims to test whether the use of a nicotine patch may accelerate the healing~     process from AVN of the knee.~   "
82147|NCT01982149|"~     Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death~     in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and~     prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of~     lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an~     important role. This study proposes to examine the genetic correlation between nasal and~     bronchial epithelium and to identify a patient's risk for lung cancer earlier.~   "
82148|NCT01982136|"~     The analysis of the long-term outcomes and quality-of-life parameters after urethral~     reconstruction surgery.~   "
82149|NCT01982123|"~     This pilot clinical trial studies single photon emission computed tomography~     (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer~     undergoing radiation therapy. Diagnostic procedures that measure lung function may help~     doctors find healthy lung tissue and allow them to plan better treatment.~   "
82150|NCT01982110|"~     Cigarette smoking is the leading cause of preventable death and disability in the world.~     Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually.~     Additional effective, safe, and accessible treatments for nicotine dependence are needed due~     to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side~     effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent~     evidence supports the central role of craving in maintaining nicotine dependence, and~     neither behavioral nor replacement therapies directly target the relationship between~     cravings and smoking. Mindfulness therapy has been found to be effective in teaching~     strategies to decouple the association between craving and smoking. Mindfulness based~     smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr.~     Judson Brewer has recently translated this program into a mobile device application (app)~     for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility~     of implementation of a MT mobile application in local hospital and community clinics and the~     effectiveness of the MT mobile application compared to a National Cancer Institute (NCI)~     QuitPal behavioral change group. We will examine smoking results at end of treatment and 2~     and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined~     to be effective in a mobile phone application, this finding will be a significant step in~     providing an additional effective and safe treatment for smokers wishing to quit or cut down~     on their intake, and will be especially important in providing treatment options for~     marginalized or hard-to-access individuals wishing to reduce cigarette intake.~   "
82151|NCT01982097|"~     This local, prospective, multicenter, non-interventional study documents observational data~     on patients under routine treatment of metastatic RCC with Nexavar before and after~     cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive~     nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit~     from Nexavar before cytoreductive nephrectomy.~   "
82152|NCT01982084|"~     Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in~     babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection~     die and half of babies with GBS meningitis are left with long term problems with their~     development.~      Vaccinating pregnant women against GBS in order to protect their newborn babies is a~     promising area of research.However, many women are reluctant to accept vaccination during~     pregnancy for fear it will harm their unborn child and there is often a lack of~     understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the~     recent positive experience of immunisation against pertussis in the United Kingdom, suggest~     that antenatal immunisation can be acceptable.~      Previous research has shown that advice from maternity healthcare professionals regarding~     vaccination is highly valued by pregnant women so it is also important to explore the~     attitudes and opinions of this group.~      The objective of this study is to assess the knowledge and attitudes of pregnant women and~     maternity healthcare professionals in England and Scotland regarding GBS disease and the~     acceptability of a potential vaccine.~      There are two parts to this study. The first part will invite pregnant women, maternity~     healthcare professionals and parents who have had a child affected by GBS disease to take~     part in either a focus group or an individual interview.~      This will allow for an in-depth exploration of the participants thoughts and opinions about~     GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site~     only. The results will guide the development of a self completed, paper questionnaire which~     will be distributed to a wider range of pregnant women and maternity healthcare~     professionals across four different study sites.~      This study has been funded by Meningitis UK. Additional collaborators to those listed~     include the charity Group B Strep Support.~   "
82153|NCT01982071|"~     To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients~     with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory~     mycosis, gastrointestinal mycosis) in adult patients in China.~   "
82154|NCT01982058|"~     RATIONALE: Participating in a therapy program may enhance communication and intimacy between~     men with prostate cancer and their partners.~      PURPOSE: This randomized clinical trial is studying how well therapy enhances communication~     and intimacy for men with early stage prostate cancer and for their partners.~   "
82155|NCT01982045|"~     The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone~     graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar~     spine, in terms of efficacy and safety.~   "
82156|NCT01982032|"~     Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients~     with severe aortic valve stenosis with similar mid-term success rates as compared to~     surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important~     limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is~     an independent predictor of mortality after TAVR. Little is known about potential~     differences in severity of PAR among different types of aortic valve prosthesis. The current~     randomized study aims to evaluate potential differences between the Edwards SAPIEN~     bioprosthesis and the Medtronic CoreValve® system with main focus on PAR and additional~     focus on other clinical and imaging endpoints. Primary objective of this study is to~     investigate the difference in the severity of PAR, measured with 3-dimensional~     transesophageal echocardiography (3DTEE), between patients undergoing the implantation of~     the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValve®~     bioprosthesis. Secondary objectives of this study include: investigating the value of~     different imaging modalities in evaluating periprosthetic regurgitation after TAVR and~     studying the difference in clinical endpoints according to VARC-2 definitions and quality of~     life after TAVR between two available aortic valve prostheses.~   "
82184|NCT01981668|"~     This study utilizes a conventional phase I study design with a '3+3 cohort expansion'~     design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and~     2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition~     of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent~     chemo-radiation are analyzable for the primary endpoint of the study.~   "
82157|NCT01982019|"~     The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to~     glucose metabolism and obesity. However, no data exists in obese patients or in patients~     with diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before~     and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels.~     The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes~     and in healthy volunteers with normal weight. Comparison of these different groups will~     permit us to better understand the 26RFa involvement in glucose concentration regulation and~     in obesity.~   "
82158|NCT01982006|"~     Cataract is the leading cause of blindness worldwide and cataract surgery is the most~     frequent surgery performed in France. A new technology, the femtosecond laser-assisted~     cataract surgery, has to be compared with phacoemulsification alone, the conventional~     cataract surgery, to determine the economic impact of femtosecond laser-assisted process for~     the French healthcare insurance.~   "
82159|NCT01981993|"~     BACKGROUND:~      Early diagnosis and prognostication of acute kidney injury in patients with sepsis is key to~     further our understanding this disease and in the evaluation of new interventions for this~     condition. Many urinary biomarkers have been proposed, but no single one seems to~     consistently provide additional information on top of clinical and routine biochemical~     parameters. Some authors have proposed to use a panel of urinary biomarkers to increase the~     accuracy However, this approach has so far not been tested in a large group of patients with~     sepsis. In addition, newer and more performant analytical techniques have been developed~     that warrant testing in the clinical field.~      PATIENTS AND METHODS:~      At least 150 consecutive patients admitted to a tertiary care intensive care unit (ICU) with~     sepsis will be included. After bladder catheterisation, urinary samples will be collected at~     time points 0, 4 hours and 24 hours after admission, and further daily on day 1-5. Samples~     will be immediately centrifuged and frozen at -80°C until analysis. Samples will be~     extracted by removing larger proteins (>20kDa) and de-salting step prior to mass~     spectrometry analysis. Investigators will use capillary electrophoresis-mass spectrometry~     (CE-MS) to assess urinary peptides predictive of AKI: 20 peptides constituting the AKI~     marker pattern previously established from a cohort of ICU patients. Simultaneously, samples~     will be analysed using matrix-assisted laser desorption ionisation time-of-flight mass~     spectrometry (MALDI-TOF MS), an alternative platform to CE-MS, which is currently being~     developed for routine ICU use. A proof of concept of the technique involved has been~     successfully applied to a set of urine samples from patients diagnosed with diabetes~     presenting normoalbuminuria (controls) and macroalbuminuria (cases).~      Clinical, demographic and biochemical data of patients will be collected during the first 5~     days.~      PATIENT OUTCOME~        -  in the short term:~             -  development of acute kidney injury according to RIFLE criteria~             -  death~             -  need for renal replacement therapy during ICU stay~        -  on the longer term~             -  death~             -  need for renal replacement therapy~             -  estimated glomerular filtration rate as calculated by MDRD at 3 months, 1 year and~               2 years.~      Using cut-offs , Receiver Operating Characteristics curves, negative and positive predictive~     value will be used to describe diagnostic performance of the biomarker panel alone, or in~     combination with basic clinical and/or routine biochemical parameters. Univariate and~     multivariate logistic regression for death will be used to evaluate prognostication value of~     the biomarker set.~      In addition, new discriminatory cut-offs of proteomic patterns as determined by more recent~     proteomic analysis techniques will be determined in a training set (half of the cohort) and~     validated in the other half of the cohort. Using the MALDI-TOF MS platform, investigators~     will assess urinary peptides that were predictive of AKI in a training set (ca. 75 patients)~     with good diagnostic performance of the marker panel (accuracy above 0.8) . Performance of~     the biomarker panel will be assessed in a blinded test set of ca. 75 patients to evaluate~     validity of the model in AKI detection.~   "
82160|NCT01981980|"~     Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of carbon~     dioxide gas [CO2] for therapeutic purposes. Radiofrequency (RF) is a method that uses~     electric current to generate heat into the layers of the skin and the subcutaneous tissue.~     Both techniques are indicated to the treatment of skin laxity. The aim of this study was to~     compare the effects of CA an RF on human skin. Methods: Eight patients who underwent~     abdominoplasty surgery received a single procedure of both treatments. Untreated skin was~     used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was~     performed on the right and RF on the left side. Sample collection period ranged from zero to~     120 days. CA was administered at a velocity of 40 ml/min, and the total quantity of CO2~     infused was approximately 20ml. RF was carried out in a temperature higher than 40ºC on the~     epidermis for 5 minutes after reaching this temperature.~   "
82161|NCT01981967|"~     The aim of this study is to further characterize the safety profile of IMOJEV®.~      Primary Objective:~        -  To describe serious adverse events (SAEs, including adverse events of special interest~          [AESIs]) up to 60 days after administration of one dose of IMOJEV®.~      Secondary Objective:~        -  To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after~          administration of one dose of IMOJEV®.~   "
82162|NCT01981954|"~     In children with a severe form of spina bifida (which is the consequence of a spinal cord~     defect) it can happen that the bladder muscle (detrusor) contracts strongly and without~     warning (neurogenic detrusor overactivity) and that the urethra (the passage connecting the~     bladder with outside) does not relax. Those children cannot void but urine leakage can~     happen when the pressure in the bladder is so high that it overcomes the closed urethra~     (overflow at high filling bladder pressure) and/or when an overactive contraction is very~     strong. The high bladder pressure before overflow occurs puts those children at risk for~     kidney damage and the overactive contractions decrease the quality of the bladder~     additionally to the fact that they can cause leakage. Therapy is aimed to decrease the high~     filling bladder pressure and the overactive detrusor contractions.~      The purpose of this study is to evaluate long term efficacy and safety of treatment with~     solifenacin succinate (the study drug) and blood levels of solifenacin succinate (the study~     drug) in children with neurogenic detrusor overactivity after multiple dose administration.~   "
82163|NCT01981941|"~     To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to~     severe primary RLS patients with moderate renal impairment and to confirm dosage and~     administration in such population.~   "
82164|NCT01981928|"~     The purpose of the study is to see how safe the study drug is and how well it is tolerated~     after dosing. The study will also investigate how the study drug is taken up, metabolized~     (chemically broken down), distributed through the body and excreted. A further aim is to~     look at how this process is possibly altered by food by giving the study drug in the~     presence and absence of meals.~   "
82165|NCT01981915|"~     Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the~     inspiratory and expiratory muscles. Consequently they do not have the strength to generate~     the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted~     cough function allows secretion to accumulate, which in turn causes narrowing of the airway~     lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's~     susceptibility to infection increases again and the vicious circle repeats itself. Severe~     secretion retention may even lead to ventilator failure. Effective secretion and cough~     management instead reduces the risk for stay in hospital. Therefore, secretion and cough~     management is a mandatory part of the therapeutic concept for treating patients with~     neuromuscular disease.~      The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the~     ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot~     study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University~     Hospital of Essen/Germany in cooperation with Research & Development at Weinmann GmbH &Co~     KG, Germany . The objective of the pilot study was to examine the therapeutic efficacy of~     LIAM as a cough support function in patients with neuromuscular disease and indications for~     mechanical ventilation.~      We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve~     the highest individual peak cough flow and ii) that this pressure is below the pressure~     needed to achieve the maximum insufflation capacity. We define the lowest insufflation~     capacity at which the best individual PCF can be achieved as optimum insufflation capacity~     (OIC). The study was performed using two different techniques in order to demonstrate that~     findings are not dependent on maneuver details but are rather based on effects of maneuver~     pressure. The protocol was limited to techniques which do not require breath stacking: i)~     insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the~     VENTIlogic LS using LIAM.~   "
82166|NCT01981902|"~     Dehydration can result from exposure to harsh environments including hot and dry desert~     climates. Soldiers and non-military workers are frequently required to work in hot, dry~     conditions, and dehydration can be productivity limiting and life threatening if~     unrecognized.~   "
82167|NCT01981889|"~     Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus,~     and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is~     associated with numerous systemic side-effects, including diabetes, osteoporosis, and~     potentially significant mood changes. The investigators wish to determine how common~     patients with inflammatory bowel disease experience mood changes when they take steroid for~     their disease.~   "
82168|NCT01981876|"~     Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading~     cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal~     is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish~     effective screening and prevention programs. The investigators hypothesize that asymptomatic~     esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is~     designed to determine the prevalence of ESD in residents of southwestern Kenya.~   "
82172|NCT01981824|"~     One of the most challenging areas currently facing obstetricians is the detection and~     management of pregnancies in which the growth of the fetus is poor. These fetuses have not~     only increased rates of perinatal morbidity and mortality, but also have higher levels of~     morbidity extending into adult life (Linda; Murray 2010).~      In developing countries including Egypt, low birth weight is a national concern and~     emphasized in population and health policies according to the latest WHO data published in~     April 2011 low Birth Weight Deaths in Egypt reached 13,587 or 3.74% of total deaths,~     Mortality was more frequent in LBW (31.6%) than normal birth weight (NBW) infants (2.0%).~      Fetal growth restriction (FGR) is defined as fetuses whose growth velocity slows down or~     stops completely because of inadequate oxygen and nutritional supply or utilization (Linda;~     Murray 2010). Low birth weight (LBW) refers to an infant with a birth weight < 2500 g, Small~     for gestational age (SGA) birth is defined as an estimated fetal weight (EFW) less than the~     10th centile and severe SGA as an EFW less than the 3rd centile, (RCOG Green-top Guideline~     No.31, 2013).~      Ultrasound has been used as a tool for determining fetal health and a variety of sonographic~     parameters have been used to screen and diagnose IUGR including fetal biometry, fetal body~     proportions (Campbell et al., 1994), amniotic fluid volume (Owen et al., 1999), subcutaneous~     tissue thickness and estimated fetal weight (EFW) (Larciprete et al., 2005).~      IUGR is associated with changes in the body proportions as undernourished fetus directs most~     of its energy to maintain the growth of vital organs, such as the brain and heart, at the~     expense of the liver, muscle and fat and this results in decreased abdominal and thigh~     circumference measurements and hence theoretically increased HC/AC, FL/AC and FL/TC ratios~     (Colley et al., 1991).~      Fetal thigh circumference has a role to play in accurately measuring fetal weight when~     incorporated with other fetal parameters and provide a potentially straightforward method~     for assessing the deposition of muscle and fat in the growing fetus; there is a scope of~     using the FL/TC ratio in predicting IUGR (Sanyal et al., 2012).~      Fetal thigh circumference to femur length ratio (FL/TC) seems to be potential for use in~     predicting IUGR (Shripad; Varalaxmi, 2005).~   "
82173|NCT01981811|"~     The purpose of this study is to evaluate adherence to treatment with, and safety and~     tolerability of, the medical information device #1 (MIND1) system in subjects with~     Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.~   "
82174|NCT01981798|"~     To investigated whether an ambulant intervention program with a behavioral therapy approach~     would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the~     effect on patients with pronounced fear avoidance behavior and/or with psychosocial~     limitations was addressed.~   "
82175|NCT01981785|"~     The immune system is an intricate system comprised of specialized cells, proteins, tissues~     and organs. Proper functioning is critical to the body's ability to defend itself against~     harmful pathogens. Immunological disorders and deficiencies are defects in the immune system~     that lead to abnormal immune responses. Abnormal immune responses could be derived from~     immune deficiencies, dysregulations or hypersensitivities.~      The overall goal of this research study is to identify the mechanisms of primary immune~     deficiencies and immune disorders at the genetic, cellular and molecular level, using novel~     analytic techniques to be performed on immune cells derived from blood samples. The~     knowledge gained from the aims of this study could lead to better diagnostics and identify~     novel targets for therapeutic interventions.~   "
82176|NCT01981772|"~     The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine~     solution for incision and drainage. Ninety patients will be examined clinically to determine~     a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and~     drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6~     ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients~     will rate pain prior to and throughout the procedure.~   "
82177|NCT01981759|"~     This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT~     sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to~     testing efficacy, this trial will characterize DCS effects in terms of time course and~     persistence of response and will examine DCS effects on memory consolidation and cognitive~     flexibility as possible mediators of DCS enhancement of CBT for delusions.~   "
82178|NCT01981746|"~     To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce~     the number of subjects with impaired muscle strength following adductor canal block. We~     hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps~     strength compared with an adductor canal block with 30 ml.~   "
82179|NCT01981733|"~     The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb~     using electrical stimulation. Increases in lower limb blood flow improve venous return and~     thereby reduce venous stasis. Since stasis is one of the compounding factors in the~     development of deep vein thrombosis, the risk of developing thrombosis should theoretically~     be proportionally reduced. This technique may prove to be a useful tool in preventing and~     reducing the incidence of deep vein thrombosis in both medical and surgical patients~     together with passengers undertaking significant duration travel (as travel - related deep~     vein thrombosis is not exclusively related to flying).~   "
82180|NCT01981720|"~     To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult~     Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01~     and PB-102-F02. Patients will be enrolled to receive the same dose of PRX-102 (0.2 mg/kg,~     1.0 mg/kg, 2.0 mg/kg), as an intravenous infusion every 2 weeks for 24 Months.~   "
82181|NCT01981707|"~     Until today no current diagnostic tool exists to identify an early objective response when~     patients with castration-resistant prostate cancer were treated by abiraterone acetate or~     enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait~     12 weeks before the first evaluation. To know soon that the treatment is effective will be~     decisive for the oncologist, even more in palliative situation where second effects can't be~     imposed to patients.~      In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new~     therapy. Moreover, the investigators suppose that we can assess an early stage if there is~     an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily~     and expansive treatment.~      The aim of this study is to assess if it is possible to determine early (6 weeks of~     treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or~     enzalutamide in post-docetaxel.~   "
82182|NCT01981694|"~     This study will determine the safety and tolerability of PF-06649751 given orally to healthy~     volunteers. To determine the optimal dose for future studies, the concentration of the drug~     over time will be determined by periodic blood samples. The rate of eye blinks will be~     measured as an indicator of PF-06649751 action on the receptors of interest in the brain.~   "
82183|NCT01981681|"~     PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and~     tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque~     psoriasis. The goal of the study is to assess the safety, local tolerability, and~     pharmacokinetics in healthy subjects.~   "
82185|NCT01981655|"~     The objective of this trial to see whether:~      -Cardiac performance (cardiac index and secondary outcomes)can be improved in patients with~     acute heart failure (AHF) and symptoms and consequences of fluid overload (pulmonary and~     interstitial edema) and poor peripheral perfusion can be reduced by:~        1. Providing lactate as a substrate(Improve cardiac index)~        2. Simultaneously restoring optimal preload~      Optimal standard treatment will be achieved in both arms with the use of current best~     treatment protocol for AHF as per independent treating physician.~      4. To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters~     (sodium, potassium, chloride, pH, bicarb, base excess, albumin)~      5. To assess effects of 0.5M Na lactate on morbidity and mortality.~   "
82186|NCT01981642|"~     -  Study Purpose: The purpose of this study is to evaluate the sensitivity/specificity of~          noninvasive diagnostic methods for the cardiac function that are based on data~          available from the Left Ventricular Assist Device (LVAD). These diagnostic methods will~          be compared to standard clinical diagnostic procedures both at rest and during~          exercise.~        -  Study Design: The study is a prospective interventional cohort study.~        -  Patient cohort: Thirty heart failure patients who had or are about to have a LVAD~          implanted.~        -  Data Collection: The acquisition of LVAD data (motor current and speed) and wristwatch~          accelerometry data concurrently to the documentation of routine clinical examinations,~          such as cardiac ultrasound, electrocardiography (ECG), cardiac catheterization, and~          exercise tests, will be performed.~   "
82187|NCT01981629|"~     Currently, bedside ultrasound (US) is performed routinely in emergency department (ED)~     patients with undifferentiated shock to help guide resuscitation. Previously, it has never~     been possible to measure cardiac output on patients in the ED. Our clinical question looks~     at whether the USCOM device gives clinically relevant information in addition to ED cardiac~     US in patients with shock.~   "
82188|NCT01981616|"~     The primary purpose of this study is to determine the rates of seroconversion to a hepatitis~     B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.~     Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine~     series, assess change in anti-hepatitis B surface antibodies and assess the safety and~     tolerability of a single 750-mg IV dose of vedolizumab.~   "
82189|NCT01981603|"~     Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait~     listing and number of transplants. The navigator will provide tailored information and~     assistance to help dialysis patients complete the tasks required at each step in the~     transplant process. In the control group, dialysis patients will continue to get usual care~     from their nephrologists and dialysis facility personnel.~      Hypothesis: Compared to control patients, intervention patients will be significantly more~     likely to be wait listed or receive a kidney transplant.~   "
82190|NCT01981590|"~     The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to~     evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter~     advanced into the great veins.~   "
82191|NCT01981577|"~     The purpose of this study is to investigate the segregation of the subthalamic nucleus into~     its motor and non-motor regions in patients with Parkinson's disease and healthy controls~     with the aid of ultra-high field magnetic resonance imaging.~   "
82192|NCT01981564|"~     Asthma is the number one cause of pediatric emergency department (ED) visits in young~     minority children and is responsible for high healthcare costs. The ED is often the point of~     contact for many inner city children and many families view the ED as the child's primary~     source of asthma care. This study plans to test a new model of asthma care, Asthma Express~     (AEx), that includes a follow-up asthma visit in the ED for an asthma check-up , asthma~     education, a prescription for preventive asthma medications, an appointment for the child to~     see their pediatric provider and a home visit to assist families with environmental control~     methods to prevent asthma symptoms.~   "
82193|NCT01981551|"~     Background:~        -  Desmoid tumors (also known as aggressive fibromatosis), are rare, locally invasive,~          slow-growing soft-tissue tumors. The disease can be either asymptomatic or be~          associated with severe loss of organ function and significant morbidity.~        -  Treatment with the selective small-molecule Gamma-secretase inhibitor PF-03084014~          caused significant tumor shrinkage in patients with unresectable desmoid tumors in an~          early phase clinical trial.~        -  The Notch pathway is a key regulator of cell differentiation, proliferation and~          apoptosis; aberrant signaling via the Notch pathway is associated with carcinogenesis.~      Objectives:~        -  Primary: Determine the response rate (CR+PR) of PF-03084014 in patients with desmoid~          tumors/aggressive fibromatosis~        -  Secondary: Assess symptom measures at baseline and on study; perform genotyping for~          germline and somatic mutations in APC and CTNNB1 genes; correlate clinical response to~          therapy with genotyping data; and assess modulation of the Notch pathway by evaluating~          notch response genes in tumor biopsies at baseline and after drug administration~      Eligibility:~        -  Age greater than or equal to18; histologically confirmed desmoid tumor not amenable to~          curative resection or definitive radiation therapy that has progressed after receiving~          at least one line of standard treatment; adequate organ function~        -  Willingness to provide blood samples and 10 unstained slides or a tumor block for~          genetic research studies~      Study Design:~        -  This is an open-label Phase II trial of PF-03084014; study drug will be administered~          orally at 150 mg twice a day in 21-day cycles~        -  Optional tumor biopsies for research purposes will be performed at baseline prior to~          study treatment and at the beginning of cycle 7 (+/- one cycle)~        -  Restaging scans (MRI with diffusion weighting) will be performed at baseline, at the~          end of cycles 1 and 6, and then every 6 cycles~        -  Health-related quality of life (HRQOL)/symptom questionnaires will be administered at~          baseline and at each Clinical Center visit~   "
82194|NCT01981538|"~     Background:~      - Caring for a loved one is often stressful. Some studies show it may affect health and~     emotions. Researchers want to know more about this but do not know the best way to gather~     data. They want to know if an online survey is a good way to gather data from caregivers of~     people receiving cancer treatment at the NIH Clinical Center. They want to know if there are~     differences among caregivers depending on the type of cancer treatment the family member or~     friend is receiving. They want to use this data to improve support programs for caregivers.~      Objectives:~      - To see if an online study is a good way to get data from caregivers of people with cancer.~      Eligibility:~      - Adults 18 years old and older who are taking care of a cancer patient at the NIHCC.~      Design:~        -  The study period begins when the family member or friend begins a new cancer treatment~          and continues for 6 months afterward.~        -  Participants will complete an online survey 3-4 times. This will include questions~          about caregiving, stress, emotions, and spirituality. The survey can be taken anywhere~          on a computer. It will take about 30 45 minutes each time.~        -  Participants will also answer general questions about themselves and their health. This~          will be done over the phone with the study team. It will take 5 minutes.~   "
82195|NCT01981525|"~     Background:~        -  Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer~          predisposition disorder. Four main cancer types including sarcoma, adrenocortical~          carcinoma, breast cancer, and malignant brain tumors commonly characterize LFS but the~          syndrome can include other cancers.~        -  Metformin is an oral biguanide drug that is approved by the FDA for the treatment of~          type II diabetes. Metformin has been associated with reduced cancer risk in several~          epidemiologic studies and reduced cancer mortality in patients with type 2 diabetes.~        -  Metformin decreases circulating insulin and IGF1, and promotes glucose uptake in~          skeletal muscle and inhibits gluconeogenesis in the liver. Elevations in circulating~          insulin and IGF1 levels have been associated with increased cancer risk.~        -  Preclinical research in animal models shows that metformin may be more toxic in cancer~          cells that have lost p53 function.~        -  Lifetime risk of cancer in LFS patients with germline TP53 mutations is estimated to be~          up to 70% by age 60, with women having excess lifetime cancer risk (up to 100%)~          compared to men (up to 80%). There are currently no approved chemopreventive agents for~          patients with LFS.~        -  Metformin has been shown to be safe and tolerable in diabetic and non-diabetics, and~          may be an ideal candidate for chemoprevention of cancer in this population.~      Objectives:~        -  Determine the tolerability of oral daily metformin in patients with LFS caused by~          germline TP53 mutations.~        -  Determine if 8 weeks of daily metformin administration has any effect on circulating~          IGF-1, insulin, and IGFBP3~      Eligibility:~        -  Must have a germline TP53 mutation and provide documentation of testing.~        -  Must have adequate organ function.~        -  Age greater than or equal to 18 years.~      Design:~        -  This is a pilot study to assess the tolerability of daily oral metformin administration~          in patients with LFS caused by germline TP53 mutations and to study the effect of~          metformin on biomarker levels in these subjects.~        -  In the absence of intolerable toxicity, a minimum of 22 patients will take metformin by~          mouth for a total of 14 weeks and then discontinue metformin for 6 weeks. The total~          time on study will be 20 weeks.~        -  Patients will be assessed for biomarker levels (IGF-1, insulin, IGFBP3) by blood sample~          at baseline, and weeks 0 and 8.~   "
82196|NCT01981499|"~     PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce~     vascular permeability. The purpose of this study is to evaluate the safety, tolerability,~     pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in~     healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.~   "
82197|NCT01981486|"~     PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to~     evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999~     administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be~     evaluated in blood and blister fluid.~   "
82198|NCT01981473|"~     The purpose of this study is to examine the relationship between anti-drug antibodies, serum~     drug concentrations, and clinical response for rheumatoid arthritis patients being treated~     with etanercept, adalimumab or infliximab.~   "
82199|NCT01981460|"~     We are evaluating the effect of methylene blue and visible light activation on the~     microbiome of the skin.~   "
82200|NCT01981447|"~     The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.~   "
82201|NCT01981434|"~     Technology-Based Obesity Prevention Project (TeBOPP) is a bilingual (English/Spanish)~     family-based educational intervention that will use a novel videogame format to educate~     underserved inner city Latino children and adolescent patients and their parents about~     healthy diet and exercise. To the best of our knowledge this is the first family focused~     obesity prevention educational intervention using a gaming scenario where both parents and~     children/teens (8-15 years) participate simultaneously. The goals are to improve~     parent-child (teen) knowledge regarding healthy food habits and create a change in attitude~     towards healthy eating and exercise.~      Hypothesis: We hypothesize that game-based avatars (i.e., a graphical representation of an~     individual within a virtual space) can create change in knowledge and attitude towards~     healthy eating and exercise.~   "
82202|NCT01981421|"~     Liver fibrosis has been considered as irreversible change. However, recent study showed that~     early stage liver fibrosis could be reversible and a lot of new drugs are now developing or~     developed including anti-viral treatment. Liver biopsy is considered as golden standard for~     the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of~     1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver~     fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is~     practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important.~     In this study we hypothesized that multi-parametric MR imaging including MR elastography,~     conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy~     in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform~     multi-parametric MR imaging at the enrollment and one year later to evaluate changes in~     quantitative values in MR.~   "
82203|NCT01981408|"~     This type of study is called a radiolabeled study. For this study, LY2801653 (study drug)~     has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally~     occurring radioactive form of the element, carbon. This study will increase understanding~     about how the drug appears in the blood, urine, and stool after it is administered to~     healthy people. Information about any side effects that may occur will also be collected.~     This study will last up to 15 days for each participant, not including screening. Screening~     is required within 28 days prior to enrollment.~   "
82204|NCT01981395|"~     Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a~     significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with~     placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally~     we are going to assess changes in mood/affect and cognitive function of subjects following~     administration of fenobam and after cutaneous sensitization compared to baseline.~   "
82205|NCT01981382|"~     This research study will examine whether enhanced pain sensitivity increases the risk of~     persistent low back pain. The study will address the highly prevalent and costly condition~     of persistent low back pain and a major obstacle for the implementation of clinical~     strategies to improve patient outcomes. The knowledge gained from this study may lead to a~     better understanding of the biological mechanisms that contribute to persistent low back~     pain and will inform future work to develop predictive measures of persistent low back pain~     risk, evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to~     identify patients who are at increased risk of persistent low back pain.~   "
82213|NCT01981278|"~     The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs~     with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER)~     250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg~     prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted~     conditions.~   "
82260|NCT01980667|"~     Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin~     in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in~     combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of~     this combination, to obtain preliminary information on the clinical antitumor activity and~     to conduct an exploratory pharmacogenomic (PGx) analysis.~   "
82206|NCT01981369|"~     The study will evaluate the effect of Dexmedetomidine sedation on the duration of~     infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All~     patients will receive infraclavicular block before the surgery and then they will be~     randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory~     block will be evaluated in recovery room, 24 and 48 hours after the surgery.~      Hypothesis:~      Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in~     patients scheduled for upper limb surgery.~      Secondary: Dexmedetomidine sedation~        -  Gives an adequate level of sedation during the surgical procedure~        -  Reduces the requirements of postoperative opioids~        -  Improves the quality of sleep on the night of the surgery~        -  Increases patients satisfaction regarding the anesthesia technique~        -  Dexmedetomidine sedation is safe and easy to use~        -  Dexmedetomidine sedation provides less respiratory depression during the procedure.~   "
82207|NCT01981356|"~     There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health~     Administration (VHA) inpatient services for psychosis and tailoring them to support~     recovery. The proposed pilot study will explore whether Acceptance and Commitment Therapy~     (ACT), a recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable,~     safe, and effective adjunct for the inpatient treatment of Veterans with psychosis at a~     single VHA site. Additionally, an evaluation of barriers and facilitators to future~     implementation will be conducted. If promising, the data gained from the proposed study will~     support future evaluation, implementation and dissemination efforts that have the potential~     to improve inpatient treatment for psychosis and recovery, and thus, the lives of Veterans,~     while reducing costs for VHA.~   "
82208|NCT01981343|"~     Gallstone formation is multifactorial: immutable risk factors include genetics and~     ethnicity, age and being female, and mutable risk factors include obesity, and metabolic~     syndrome, diet, rapid weight loss, and other conditions such as cirrhosis, Crohn's disease,~     irritable bowel syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone.~     Previous studies have linked serum cholesterol, and low-density lipoprotein cholesterol~     levels and fatty liver disease to gallbladder disease. Given betaine's reported beneficial~     effects on fatty liver and lipid profile, A-F Betafood® may have a beneficial effect on~     gallbladder function.~      The objective of the study is to assess the effect of A-F Betafood® on gallbladder and liver~     function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is~     that A-F Betafood® will improve gallbladder and liver function after the 12 week treatment~     period.~      This is a single-center, randomized, double-blind, placebo-controlled, parallel group study~     with two arms. This study will consist of a single 12 week treatment period. The planned~     sample size for this study is 50 overweight female subjects, with 25 subjects randomized~     equally to each of the two study arms in double-blind manner at a ratio of 1:1~   "
82209|NCT01981330|"~     This is a pilot-study of 25 selected Swedish patients which all have severe hoarseness or~     aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation~     or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the~     scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma~     cells, aMSC (which were previously harvested from each patients´s bone marrow, purified,~     expanded and characterized according to standard procedure at the Center of Hematology and~     Regenerative Medicine Karolinska University Hospital Huddinge). 14 Patients is planned to be~     treated with a single injection of aMSC and 11 patients with injection of aMSC mixed with a~     carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska~     Institute. The laryngeal status, vocal fold function, and voice function will be followed~     individually with an advanced battery of examinations performed before and up to 1 year~     postoperatively. Side effects and complications are noted and reported during surgery and~     following surgery at regular intervals during at least 1 year Since autumn 2015 no new~     patients have been recruited and no treatments are given during 2016. The monitoring~     authority was changed from Swedish National Board of Health to Swedish Medical Product~     Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until~     permission is granted from MPA to continue the study.~   "
82210|NCT01981317|"~     The purpose of this research study is to determine how well children with OCD can be helped~     using therapy that requires less clinic visits. The investigators are testing a Stepped-Care~     Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of~     parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in~     fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which~     includes three therapy sessions over six weeks. Those who do not get better in Step One will~     STEP UP to Step Two which involves coming in to meet with a therapist for the remaining~     sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the~     clinic through this study. It is expected that Stepped Care will be an acceptable,~     cost-effect, and feasible treatment with outcomes similar to standard CBT.~   "
82211|NCT01981304|"~     Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction~     and inflammatory reactions, which in turn delay healing and endothelialization and may lead~     to the occurrence of major adverse cardiac events (MACE), such as restenosis,~     atherosclerosis, and stent thrombosis.~      Drugs, platforms and polymers are considered the protagonists of these pathophysiologic~     processes.~      The objectives of the INERT study is to assess the extent of inflammation and endothelial~     damage induced by the first carbonized bio-absorbable coated rapamycin-eluting coronary~     stent at time of percutaneous coronary intervention and correlate the extent of these~     abnormalities with short and long-term clinical outcome and post-procedural evaluation of~     success.~      As part of the study, a randomized sub-study will be carried out at the Coordinating Center~     in order to compare the biohumoral, clinical and procedural findings between patients with~     the carbonized bio-absorbable coated rapamycin-eluting coronary stent and those randomly~     assigned to receive stents with different platforms and polymers.~   "
82212|NCT01981291|"~     This study was designed to assess whether the injection of local anesthetic into the nerve~     (intraneural), as opposed to around it (perineural), leads to longer anesthesia and~     analgesia of the leg.~      Some reports of accidental intraneural injection mention an extremely long duration. When~     different drugs and doses were evaluated in a clinical trial of intraneural injection, a~     longer-than-expected duration was reported.~      The investigators will compare the two types of injection using the same drug, so as to~     determine if there is an actual difference in duration.~   "
82214|NCT01981265|"~     This is a case-control study involving one medical center and one research institute to~     develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100~     independent controls of similar gender ratio and a minimum of 100 disease controls (cases~     with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes~     with osteoarthritis phenotypes.~      This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica~     (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National~     Taiwan University Hospital.~   "
82215|NCT01981252|"~     This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled~     subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions,~     each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days~     following treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit.~   "
82216|NCT01981239|"~     It was well known that aspiration is the primary cause of an aspiration pneumonia among the~     dysphagia patients.~      In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and~     fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are~     invasive and allowed only in a limited condition.~      In this study, as a precedent study for the non-linear analysis, voice analysis using LPC~     method will be evaluated. The superiority of LPC method will be compared with a spectral~     analysis using Jitter and Simmer as a positive control.~      This clinical study will be performed prospective, positive-controlled, single-blind (i.e.~     assessor-blind),and single cohort clinical trial for efficacy~   "
82217|NCT01981226|"~     Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar~     fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography~     of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness~     increased after ESWT as clinical symptom improves.~   "
82218|NCT01981213|"~     A: Early predictors of hepatic injury after suicide attempt with acetaminophen:~      To explore the following in a pediatric population with acetaminophen overdose due to~     suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the~     relationship between the total number of vomiting episodes and hepatic injury, 2) the~     relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and~     3) the presence/absence of illness prior to the suicide attempt and hepatic injury.~      B: Characteristics, social behaviour, trends and risk factors:~      1. To explore the relationship between children admitted to a paediatric department as a~     result of suicide attempts with acetaminophen and their parents and friends. 2. To determine~     the extent to which the children had attempted to speak to their parents or other adults~     about their problems before their suicide attempts. 3. To determine the prevalence of~     self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these~     suicide attempts.~      C: Establishment of the expression of cytochrome P450 in a pediatric including the~     age-adjusted activities.~      Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have~     already established in our lab.~      There will be categorized three groups for comparison:~        1. An age-appropriate background population (approximately 200 patients)~        2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic~          injury (approximately 50 patients)~        3. Other pediatric patients admitted to their local hospital because of acetaminophen~          poisoning (approximately 200 patients) A control urine sample will be analyzed three~          months after the suicide attempt.~   "
82219|NCT01981200|"~     To examine the feasibility of progressive unilateral knee-extension strength training using~     ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD~   "
82220|NCT01981187|"~     The purpose of this signal seeking study is to determine whether treatment with LGX818~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study~   "
82221|NCT01981174|"~     The purpose of this study is to compare the levels of pain resulting from injections of~     Botox® for wrinkles on the forehead and between the eyes using two different sized needles~     (32 gauge and 30 gauge needles).~   "
82222|NCT01981161|"~     Under the escalation treatment strategy when a patient displays breakthrough disease~     parameters under first line therapy, MS physicians are allowed by the EMEA to switch for~     Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by~     randomized therapeutic trial. As both treatments have been tested versus placebo a common~     way to compare them is to look at their respective annualized relapse risk ratio decrease.~     Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since~     the placebo group had different behaviour in the 2 trials and the patients demographic~     features at baseline are also different. Therefore, it is right now totally impossible to~     compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it.~     Unfortunately this head-to-head comparison is not available and will not probably be done~     under the drug companies initiative. During the time of this study, we will perform a phase~     IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600~     patients. Our primary end point will be disease free patients after 1 year of treatment.~     Further, this trial will allow us to collect new biological samples, useful for a validation~     our project main aim. Further these new samples will be obtained from 3 European countries,~     which is a must if we want to generalize our conclusion obtained from a French cohort.~     Cooperation at the European level is thus essential for the implementation of this project .~   "
82223|NCT01981148|"~     Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes~     in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains~     in the excited state following excitation and depends on the fluorophores molecular~     environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify~     fluorescence lifetimes in the human retina in vivo. The purpose of this study is to~     investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The~     investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress~     such as ischemia by detecting changes in fluorescence lifetimes.~   "
82234|NCT01981005|"~     This non-randomized, single group, open-label study will investigate the mass balance,~     routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802~     and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers~   "
82224|NCT01981135|"~     Purpose: The purpose of this protocol is to understand how individuals respond to the air~     pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the~     risks from poor air quality are during a heat wave.~      Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in~     this study.~      Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2~     hours with intermittent exercise in a controlled environment chamber. For each exposure the~     temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study~     is to mimic high exposure during a heat wave, we will perform exposures only on days when~     mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day.~      Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary~     endpoints will include analysis of blood clotting/coagulation factors, and analysis of~     soluble factors present in plasma.~   "
82225|NCT01981122|"~     This is a randomized, open-label study designed to assess the effects of sipuleucel-T when~     administered concurrently or sequentially with enzalutamide.~   "
82226|NCT01981109|"~     The primary purpose of this research is to describe patient characteristics predictive of an~     imaging study positive for distant metastases in patients with castration-resistant prostate~     cancer and no known distant metastases.~   "
82227|NCT01981096|"~     The purpose of this pilot randomized trial is to determine whether the fibromyalgia~     integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy~     (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).~      Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in~     pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).~      Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions~     in functional disability and depressive symptoms at final study assessment (i.e., 3-month~     follow up).~   "
82228|NCT01981083|"~     Malnutrition is seen frequently in hemodialysis units in most developing countries.~     Malnutrition increases morbidity and mortality in this population and its treatment improves~     patient survival and health status The purpose of this study is to compare two strategies to~     improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml)~     versus egg albumin-based protein supplement (30 g) on a daily basis.~      This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment~     (SGA) in addition to most used biochemical markers to determine nutritional status.~   "
82229|NCT01981070|"~     The purpose of this study is to evaluate the impact of two community based interventions for~     parents of adults with intellectual or developmental disabilities (IDD) who are requesting~     services.~      The two interventions will include:~        1. Support and Information Intervention - provides parents with support and information~          about services for their sons and daughters~        2. Mindfulness Intervention - empowers parents through teaching them mindfulness skills~      We hypothesize that:~        1. Parents in both types of interventions will report benefits (reductions in~          psychological distress) maintained at follow-up.~        2. Parents in mindfulness intervention group will report improvements in mindful~          parenting, self compassion, positive gain, empowerment, and reduced burden. Parents in~          support and information intervention group will report improvements in empowerment,~          positive gain, and reduced burden.~        3. Parents in mindfulness intervention group will show greater improvements by 3 months~          follow-up than parents in the support and information group.~   "
82230|NCT01981057|"~     The aim of this prospective noninterventional study is to evaluate the clinical application~     of Numeta® in preterm infants and critically ill neonates in comparison to individualized~     prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software~     solutions) exact valid prescriptions for ordering parenteral nutrition solutions for~     premature infants are compared. Each PN solution is prescribed individually as well as with~     Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume~     and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for~     calculating Numeta prescriptions was protein. The results of PN prescriptions were compared~     with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental~     content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition~     solutions~   "
82231|NCT01981044|"~     Prospective, multi center, single arm, clinical study to obtain clinical experience with the~     use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.~   "
82232|NCT01981031|"~     BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin~     Lispro.~      The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in~     subjects with type 1 diabetes under a dose of 0.8 U/kg.~      This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period~     cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes~     mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of~     BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate~     dosing visits.~   "
82233|NCT01981018|"~     Bipolar Disorder (BD) (previously known as manic depression) is a severe mental health~     illness affecting at least 1% of the population and with annual NHS cost estimated at £342~     million. It is characterised by alternating episodes of acute mood swings: depression and~     mania (mood elation). BD also comes with less severe mood swings we call mood~     instability, and ongoing high levels of anxiety that impair well-being even during periods~     between the acute mood breakdowns. Anxiety and mood instability are associated with worse~     outcome of the disorder.~      All these symptoms can be accompanied by the presence of troublesome mental images (e.g.~     seeing a memory in the mind's eye) such as intrusive flashbacks of negative past events.~     Recent studies suggest that individuals with BD experience more vivid, compelling and~     upsetting mental images compared to other patient groups and this could contribute to their~     clinical difficulties.~      Cognitive Behavioural Therapy (CBT) is a well established and successful psychological~     therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in~     BD. Targeting mental imagery has long been part of general CBT. In particular, imagery-based~     treatment techniques have proved successful in anxiety disorders, but have not been brought~     to CBT for Bipolar Disorder yet.~      Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief~     imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series~     of patients in detail one by one a case series). We offer a structured and individualised~     psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been~     successfully delivered and audited in our psychological service in Oxford (OxMAPP). The~     proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In~     particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will~     result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment~     compared to baseline (both measured over 4 weeks) in individuals with BD.~      Overall, this works aims to contribute to improved psychological treatment for BD.~   "
82237|NCT01980966|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be~     intranasally oculated with the challenge virus and will be randomly assigned to receive a~     intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be~     randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally~     twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7~     to Day 11.~   "
82238|NCT01980953|"~     This 4-part study will assess the effect of formulation, food, and active pharmaceutical~     ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an~     open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period~     crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet~     formulation, in the fasted or fed state.~   "
82239|NCT01980940|"~     Study Part 1 is designed to assess the plasma pharmacokinetics of etoricoxib (ETOR) 4%~     dimethyl sulfoxide (DMSO) and propylene glycol (PG) formulations, each at 2 different doses,~     upon single-dose topical administration on the knee of osteoarthritis participants. Study~     Part 2 is designed to evaluate the efficacy of topical etoricoxib vs. placebo in the~     treatment of osteoarthritis of the knee. The primary hypothesis is that topical etoricoxib~     will be more effective than placebo in the treatment of osteoarthritis of the knee over 2~     weeks of treatment as assessed by time-weighted average change from baseline on the Western~     Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analogue (VA) 3.0 pain~     subscale.~   "
82240|NCT01980927|"~     A small number of chiropractors, who align only the atlas C-1, or top vertebra in the~     spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas~     correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to~     correct misalignment of the atlas. Although NUCCA practitioners have long used this~     procedure in the treatment of headache, it has not been formally studied using clinical~     trials. There is some data indicating that NUCCA correction can increase intracranial~     compliance. This intracranial compliance can be measured by a magnetic resonance imaging~     (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope~     to show that the correction of an atlas misalignment will increase intracranial compliance~     in subjects with migraine.~   "
82241|NCT01980914|"~     The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes~     increases with age. Hypoglycemia is a common reason for admission to hospital for older~     patients with diabetes. Older patients are often unaware that their blood sugar is low and~     asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in~     the elderly. There is also evidence that older people with diabetes are more likely to~     develop cardiovascular events such a heart attack and more likely to die suddenly when~     compared to older people without diabetes. It is possible that low blood sugar levels~     contribute to the increased frequency of these events, but this possibility has never been~     studied. The purpose of this study is to assess how frequently low blood sugar occurs in~     older patients with diabetes and to see if low blood sugars adversely affect heart function~     in these patients.~   "
82242|NCT01980901|"~     The Post-Approval Study (PAS) will evaluate the real world data on the Ovation™/Ovation~     Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE~     cohort to monitor the long-term safety and effectiveness of the device.~   "
82243|NCT01980888|"~     This study will evaluate the effect of the addition of idelalisib to bendamustine and~     rituximab on minimal residual disease (MRD) and evaluate the progression-free survival (PFS)~     in participants with previously untreated chronic lymphocytic leukemia (CLL).~   "
82244|NCT01980875|"~     This study will evaluate the effects of idelalisib with obinutuzumab versus the combination~     of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with~     previously untreated chronic lymphocytic leukemia (CLL).~   "
82245|NCT01980862|"~     Single-site blood collection investigation.~   "
82246|NCT01980849|"~     To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin~     during hospitalization to long-term usage in patients with advanced lung cancer treated by~     chemotherapy and/or radiotherapy.~   "
82247|NCT01980836|"~     Patients with rheumatoid arthritis (RA) are prone to respiratory infections and therefore~     recommmended to receive vaccination against seasonal influenza. We and others have shown a~     relatively preserved humoral response to vaccination in RA patients. However, the cellular~     response as well as the effect of biologics such as tocilizumab on the cellular response has~     not been weel studied. The purpose of this study is the evaluate the effect of tocilizumab~     on the cellular immune response to influenza vaccine in patients with RA in comparison with~     healthy controls~   "
82248|NCT01980823|"~     The purpose of this study is to determine the effects of combining metformin and~     atorvastatin treatment in patients with newly diagnosed breast cancer during the interval~     between breast biopsy and surgery.~      This study is designed to assess whether tumor proliferation, as measured by the natural log~     expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2~     weeks of treatment with the combination of metformin plus atorvastatin in patients with~     newly diagnosed breast cancer.~   "
82249|NCT01980810|"~     The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are~     effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.~   "
82258|NCT01980693|"~     Skeletal maturity assessment, defined also as bone age (BA), has an important role in~     pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty~     related endocrine disorders. Repeated BA assessment is important during the follow up of~     children with short stature, with precocious puberty and those treated by growth promoting~     medications.~      The most commonly used method used for determining skeletal maturity, and thus BA is based~     on comparison of a hand and wrist radiographs to a standard series of representative films~     in the Radiographic atlas of skeletal development of the hand and wrist by Greulich and~     Pyle (GP), which has been issued several decades ago. The suggested method in this study is~     based on ultrasound technology, and therefore it is quick, objective, and radiation-free. It~     delivers an immediate non biased result without the need to rely on an observer's evaluation~     of the hand radiograph and without the need for a specialized radiology facility.~   "
82250|NCT01980797|"~     Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation,~     occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign~     abnormality; but in older adults it is associated with thoracic aortic aneurysm or~     dissection in 20-30% of those with BAV. BAV is strongly associated with early development of~     aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of~     the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know~     little of the etiology, cellular events and modifiers of progression of BAV to calcific~     aortic valve disease and we still do not understand the genetic cause(s) of BAV despite~     evidence for its high heritability.~      The Specific Aims of this study are:~        1. To identify the genetic causes of bicuspid aortic valve disease and its associated~          thoracic aortic disease.~        2. To identify potential pathways to predict the clinical course of BAV disease and for~          treating human BAV disease.~      To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium~     (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to~     fulfill the performance of these aims.~   "
82251|NCT01980784|"~     Severe trauma induces massive metabolic changes that are characterized by hypermetabolism~     with increased energy expenditure and catabolism. Early enteral and, if necessary,~     parenteral feeding is a major focus of modern intensive care medicine.~      After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of~     muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads~     to a decrease in energy expenditure. Whereas other survivors of severe trauma typically~     regain muscle mass during rehabilitation, spinal cord injury patients typically continue to~     lose muscle mass over time, which also leads to changes in body composition. The time course~     of these changes is not known. Continuing nutrition without adaption to the reduced energy~     expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury~     patients to the known unfavorable metabolic consequences. Knowledge of the time course of~     these changes would help to provide adequate caloric intake to the patients and improve our~     ability for nutrition counseling.~      The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients~     to determine the changes in energy expenditure and body composition. Major inclusion~     criteria are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS~     (American Spinal Injury Association Impairment Scale) A, B or C.~      Measurements of energy expenditure, body composition and nutritional markers in venous blood~     are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of~     rehabilitation (at the latest after 26 weeks).~   "
82252|NCT01980771|"~     This program utilizes a community-engaged research approach to implementing and evaluating a~     program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The~     investigators aims are to assess the impact of this linguistically and culturally tailored~     HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and~     older, to assess the intervention's impact on the more proximal social and psychosocial~     variables that the program is designed to change, and to identify key contextual level~     factors that may impact the intervention's impact across segments of this priority~     population.~   "
82253|NCT01980758|"~     The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP)~     on excess body weight, body mass index, and weight-related medical and psychological~     co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy~     of this procedure (implemented within a multidisciplinary comprehensive lifestyle~     modification program) on changes in the patients' medical status, psychosocial and~     psychological functioning, physical fitness, and health-related quality of life.~      Study hypothesis:~        1. Laparoscopic gastric plication performed on carefully selected obese adolescents within~          a multidisciplinary treatment program providing pre and post-surgical behavioral and~          psychological support and education will result in: a) initial and sustained reductions~          in excess body weight and body mass index, b) improvements in psychological~          functioning, physical fitness, and health-related quality of life, and c) reduction in~          weight-related comorbidities.~        2. LGP will be a safe procedure, with complication rates that are comparable to or lower~          than what has been found in other published reports of surgical weight loss procedures~          used in obese adolescents.~   "
82254|NCT01980745|"~     Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use~     of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly~     treated, patients have a good survival. One of the major problems related to its treatment~     is the the high rate of relapses after stopping therapy that has lead to biochemical and~     histological remissions, close to 80%. Many authors recommend continuous treatment~     throughout life, resulting in the occurrence of many side effects. Chloroquine is a drug~     with anti-inflammatory properties already used in the treatment of other extrahepatic~     autoimmune liver diseases. There are some reports in the literature about its beneficial use~     in liver diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune~     hepatitis, in which its use was associated with a 6.49 times lower risk of disease~     recurrence when compared with patients in whom treatment was discontinued after remission.~     Our purpose is to investigate, in a double-blind randomized trial with placebo, whether~     chloroquine prevents the recurrence of AIH in patients with histological remission after~     discontinuation of conventional treatment and to evaluate the occurrence of side effects.~   "
82255|NCT01980732|"~     The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and~     monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors,~     medullary thyroid cancer and other cancers expressing somatostatin receptors.~   "
82256|NCT01980719|"~     The purpose of this study is to determine if inflammatory markers in blood as well as brain~     neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or~     chronic fatigue.~   "
82257|NCT01980706|"~     The proposed study will carefully test the hypothesis that a robust dose of baclofen (90~     mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the~     proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day,~     predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety~     effects of baclofen within an alcohol dependent population and ascertain whether baseline~     levels of anxiety predict response to baclofen.~   "
82261|NCT01980654|"~     This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib~     combined with rituximab in previously untreated subjects with FL.~   "
82262|NCT01980641|"~     Background. Cognitive, communication and physical weakness combined with environmental~     changes frequently cause changes in roles, routines and daily occupations. The educational~     intervention combines the best choice for teaching new behaviours since it involves the~     active participation of the patient in learning.~      Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have~     suffered a stroke with moderate severity and who have been discharged to their homes.Outcome~     variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable~     dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will~     include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and~     a 2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's~     d).~   "
82263|NCT01980628|"~     Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy~     of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).~   "
82264|NCT01980615|"~     This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period,~     Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of~     Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose~     of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of~     Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is~     to determine a dose of budesonide that when formulated with glycopyrronium and formoterol~     fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to~     budesonide following administration of Symbicort MDI.~   "
82265|NCT01980602|"~     Title: How does exercise improve the calf muscle in patients with poor blood supply to their~     leg?~      Purpose of the project: Patients with peripheral arterial disease have a poor blood supply~     to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen~     as easily as a healthy leg would. This causes pain when walking (intermittent claudication),~     which often occurs after a reproducible distance e.g. every 50 yards. These patients have a~     reduction in their quality of life as they feel embarrassed in social situations e.g.~     walking around town requires multiple breaks, so they tend to avoid this and isolate~     themselves more.~      One treatment for claudication is exercising until the pain comes on; which most are~     reluctant to do. Walking up to three times a week for an hour, can double most people's~     walking distances, but doesn't always. The reason why some improve with exercise and others~     do not remains unknown.~      This project will be the first randomised controlled trial of exercise in claudicants that~     focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare~     muscle cells from a group that have exercised and group that have not. We will focus on the~     change in muscle cell size and function at present, and later progress to why and how this~     happens.~      Methods: We will take measurements at the start of the study (baseline), after 6 weeks and~     then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking~     distances and blood samples. At the time of surgery, muscle from the calf will be taken from~     the affected leg. This will be processed at the University's biomedical science department~     to look at the different types of muscle fibre and how efficiently they are working.~   "
82266|NCT01980589|"~     The primary objective was to determine the maximum tolerated dose of carfilzomib given twice~     weekly in combination with cyclophosphamide and dexamethasone for patients with newly~     diagnosed multiple myeloma.~   "
82267|NCT01980576|"~     The purpose of the study is:~        -  to measure sensitization of the nociceptive system at patients with low back pain in~          order to carry out a necessary surgical procedure~        -  to examine a possible association between low back pain and degenerative changes~        -  to analyse if low back pain is related to the clinical result 6 months after surgery~        -  to set up a model for pre-operative measurement of pain.~   "
82268|NCT01980563|"~     Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm~     injection (ICSI) can be simplified by reducing the procedure to measuring follicles by~     ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to~     simple monitoring by ultrasound while maintaining results (numbers of mature oocytes,~     percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling~     for measuring hormone levels is still the state of the art in many clinics. A large review~     (Cochrane review) stated that although there was no clear evidence for a better outcome,~     combined cycle monitoring was still recommended until it could be proven that ovarian~     hyperstimulation can be avoided without hormonal monitoring. Investigators therefore~     perform a study that compares the results between 2 groups: those with ultrasound monitoring~     and those with combined monitoring. Deciding when to plan the retrieval of the oocytes can~     depend on subtle differences in the number of large follicles measured by ultrasound, but~     also on hormonal levels in the blood of the patient. Therefore the investigators planned a~     randomized study in the group of patients with combined monitoring. The investigators~     examined if delaying the moment for planning the moment of oocyte retrieval by 24 hours had~     any effect on the number of mature oocytes and pregnancy rates and what the effect of rising~     progesterone levels might be. The investigators hypothesis was that combined monitoring~     could lead to better results since recent studies have thought that rising progesterone~     levels, if found, have a negative impact on pregnancy rates. On the other hand the~     investigators expect to find that waiting for larger follicles in cases with normal~     progesterone levels lead to a better oocyte yield.~   "
82269|NCT01980550|"~     Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by~     only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes~     for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of~     sublingual nicotine tablets (SNT) for smoking cessation and the association of~     catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial~     among Chinese smokers.~   "
82270|NCT01980537|"~     Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by~     the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might~     accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares~     magnetic with conventional wire navigation for recanalization of CTOs.~   "
82338|NCT01979653|"~     The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone~     for hemodynamic stability and quality of sedation in elderly patients under spinal~     anesthesia.~   "
82271|NCT01980524|"~     There is evidence that inhibition of FFA-release by acipimox is associated with a~     significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as~     a marker of systolic left ventricular function) in healthy subjects, indicating, that the~     heart is dependent on a constant supply of free fatty acids in order to guarantee normal~     cardiac function, and it further indicates, that the heart is not able to cover its energy~     demand by switching to glucose oxidation.~      Since that phenomenon, better known as metabolic inflexibility has been mainly described~     in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and~     cardiac function in patients with overt type 2 diabetes.~   "
82272|NCT01980511|"~     The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert~     stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute~     covert stroke using an MRI study of the brain in the days following noncardiac surgery. We~     will characterize the epidemiology and the impact of covert stroke in patients undergoing~     noncardiac surgery, and its association with cerebral deoxygenation.~   "
82273|NCT01980498|"~     The primary objective of the present phase IIIb study is to assess the efficacy of FPNS~     compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable~     BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.~   "
82274|NCT01980485|"~     Narrative: Tobacco smoking remains the single biggest cause of premature death in the United~     States and the leading cause of cancer and death from cancer. There is therefore an urgent~     need to find effective but practical ways of helping smokers to quit and stay quit. This~     randomized trial aims to evaluate two promising methods of helping smokers to quit and to~     stay quit.~      Design: This is a randomized controlled smoking cessation trial with two stages.~      In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated~     to receiving feedback on their Lung Age as estimated by their Forced Expiratory volume of~     air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1)~     or to have these measured but not fed back in a manner designed to enhance motivation to~     quit (Control group 1). All participants will be provided with group counseling (6 weekly~     sessions, with the target Quit Date on the day of the second group meeting), and transdermal~     nicotine patches.~      Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by~     exhaled CO < 10 ppm at visit 7 (4 weeks after Target Quit Date).~      In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their~     Target Quit Date), will be randomly allocated to receiving either the Forever Free relapse~     prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon~     General's Guide How Tobacco Smoke Causes Disease (Control 2)~     http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.~      All randomized participants will receive a follow-up phone call a week later to remind them~     to read and use the materials they have been given, and will attend a follow up visit (8), 6~     months after their initial Target Quit Date.~      Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit~     7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by~     exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days~     during the prior 5 months (definition of a relapse in this study).~      Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher~     quit rates 28 days after the target quit date.~   "
82275|NCT01980472|"~     A phase II Study of an adapted chemotherapy regimen plus bevacizumab in elderly non-small~     cell lung cancer patients selected by geriatric assessment~   "
82276|NCT01980459|"~     In most diabetic patients where low blood magnesium levels occur the important depletion of~     cellular levels is usually not measured. This study will measure both blood and oral mucosal~     cell magnesium levels before and after 3 months of supplementation with magnesium tablets~     (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be~     correlated with blood levels of indicators of inflammation (eg C reactive protein) to see~     whether the cellular levels are more reliable than blood levels of magnesium for appropriate~     treatment of magnesium deficiency in diabetic patients.~   "
82277|NCT01980446|"~     Determination of vital and functional outcome in comatose survivors after cardiac arrest is~     principally based on the identification of predictors of non-awakening, using by clinical,~     biological and electrophysiological tools. In patients without presence of non-awakening~     predictors, it would be of interest to identify predictive criteria of awakening. The~     presence of mismatch negativity during the cortical auditory-evoked potential could~     contribute to further progress in neurological prognostication of these patients. However,~     at this time, its prognostic value has been insufficiently studied and the optimal time of~     realization remains unknown.~   "
82278|NCT01980433|"~     Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and~     eye. The neurologic complications include dystonic syndrome, which is a prolonged and~     excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily~     life activities such as writing, which is particularly disabling, since writing is the only~     mean of communication in these patients with significant slurred speech. Treatment is~     limited and only partially effective.~      Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown~     inhibiting properties when applied over the cortex. Since dystonia has been correlated to~     hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one~     single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right~     dystonic hand, assessed immediately at the end of the session.~   "
82279|NCT01980420|"~     Improved results for sleeve gastrectomy could be possible if more was known about the~     surgical / mechanical factors that affect outcome.~   "
82280|NCT01980407|"~     In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on~     gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to~     achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the~     feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with~     advanced gastric cancer.~   "
82281|NCT01980394|"~     Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the~     esophagus and the cardia. The aim of the the study was to establish a method of mechanical~     lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer~     cells before doing the esophageal anastomosis.~   "
82293|NCT01980238|"~     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality~     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are~     undergoing anterior resections. Although debate about the use of defunctioning stoma~     continues, meta-analyses and randomized multicenter trial results support the use of~     defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted~     to evaluate the efficacy and safety of a new diversion method called spontaneously closed~     cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with~     high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI)~     method.~   "
82282|NCT01980381|"~     Depression and anxiety are among our most common diseases and the prevalence is increasing.~     When suffering from depression or anxiety, the individual's ability to cope with everyday~     life occupations is decreased, as well as the ability to relate to others. The Tree Theme~     Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop~     strategies for occupations in everyday life and relationships with others. The method~     involves using creative activities to create a life story focusing on everyday occupations~     and to create an imagination of future possibilities/goals. The TTM is a short-term therapy~     with five sessions. The treatment also implies that the patient is asked to identify various~     homework tasks to perform between the sessions.~      The aim of the project is to investigate the effects of the TTM compared to a control group~     for people with depression and anxiety diagnosis. The intention is to examine the effect on~     outcome measures regarding psychological symptoms, everyday occupations and health. The~     study has been approved by the Regional Ethical Review Board.~      The project is a randomized multicenter study with an intervention group and a control~     group. A total of 130 patients will be included. Inclusion criteria are patients with~     depression and/or anxiety in the age of 18-65 years and who have problems with their~     everyday occupations. Exclusion criteria are individuals with a severe somatic illness or~     psychosis and/or who have difficulties to understand and fill out self-rating~     questionnaires.~      The project implies that doctors will refer appropriate patients to the occupational~     therapist. After informed consent each patient will be drawn to the TTM or control. Before~     and after the treatment, as well as 3 and 12 months after finished treatment the patient~     will meet a project assistant in order to respond to questionnaires regarding psychological~     symptoms, everyday occupations and health.~      The study is a collaborative project involving the Region Skåne, Kronoberg County Council,~     and Jönköping County Council. Doctors will recruit patients and occupational therapists will~     perform the treatment. The research team comprise of researchers from Kronoberg County~     Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health~     Sciences in Jönköping (P Wagman).~   "
82283|NCT01980368|"~     This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors~     with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise~     that consists of movements with meditation and may improve peripheral neuropathy symptoms~     among cancer survivors.~   "
82284|NCT01980355|"~     Major surgery can result in blood loss that can require a blood transfusion during and/or~     after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a~     treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied~     in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We~     believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting~     in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs~     related to your surgical hospital stay.~      In this study, you will receive either the drug tranexamic acid or a placebo. The placebo~     looks like the tranexamic acid, but does not have any active ingredient in it. The treatment~     you get will be chosen by chance, like flipping a coin. You will have equal chance of being~     given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the~     placebo are considered research.~   "
82285|NCT01980342|"~     This study evaluates whether there is an interaction between etonogestrel, the progestin~     hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication~     used to treat HIV. The endpoints measured in this study will help determine if such an~     interaction leads to decreased contraceptive efficacy of the contraceptive implant.~   "
82286|NCT01980329|"~     The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome~     P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites~   "
82287|NCT01980316|"~     Argatroban is a selective thrombin inhibitor, and previous study had suggested that~     argatroban use post percutaneous coronary intervention could potentially prevent~     reocclusion. But there has no study on large sample of argatroban treated restenosis~     vertebral artery stenting. This study will test the safety and efficacy of the argatroban on~     prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.~   "
82288|NCT01980303|"~     The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the~     body does to the medication) of esketamine when given by the intranasal route (through the~     nose) to healthy adult Japanese and Caucasian participants.~   "
82289|NCT01980290|"~     The purpose of this study is to collect information on the efficacy, safety and tolerability~     of telaprevir (in combination with other medications), in patients who have a history of~     intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg.,~     methadone, buprenorphine) and/or followed in addiction centres.~   "
82290|NCT01980277|"~     The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in~     combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic~     breast cancer (MBC) is based on :~        -  the medical need in this population with either hormonal-resistant or unsensitive~          and/or rapidly progressive disease~        -  the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and~          drug resistance, including taxanes as well as its potential reversion by AKT inhibition~        -  the high level of frequency of PI3K/AKT activation in HER2-negative MBC~        -  the in vitro and in vivo preclinical activity of LY2780301, and its synergistic~          combination with various anticancer agents, including taxanes~        -  the favourable profile of tolerance of LY2780301 in phase I trial~      Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard~     treatment in breast cancer (BC) As described above, LY2780301 500 mg once daily has been~     established as the RP2D in phase I single agent trial.~      Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first~     dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.~   "
82291|NCT01980264|"~     In our research, the investigators use the non-invasive 1230 nm ultra-fast laser as the~     light source, and utilize the non-linear light microscopic system to observe your skin. This~     microscopic system is successfully developed by the Graduate Institute of Photonics and~     Optoelectronics, National Taiwan University, and has not been commercialized yet. In the~     past, observations by this technology were performed on the skin of five subjects. The early~     stage of the skin clinical trial was approved by Research Ethics Committee of National~     Taiwan University Hospital. After the trial, the tested sites of subjects were evaluated by~     a dermatologist immediately, several hours, 24 hours, 3 days, and 1 week. There were no~     inflammatory symptoms, no skin color change, no pigmentation, no wound, no blister~     formation, and no ulceration reported. According to the subjects' experiences, they felt no~     discomfort during the experiment. After the experiment, there were no inflammatory symptoms~     and signs in the observed skin areas. Therefore, the preliminary trial showed that this~     technology is safe for the subjects.~   "
82292|NCT01980251|"~     Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up~     to 80 % of patients. It is associated with significantly increased morbidity and mortality~     during admission and post-discharge. The mechanism behind the condition is poorly understood~     but assumably multifactorial, and the purpose of this study is to investigate the~     pathophysiology further.~   "
82294|NCT01980225|"~     In our centre, the implantation rate of frozen blastocysts (cryopreserved using~     vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when~     compared to data from other observational studies. Retrospective studies have shown that~     artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of~     the blastocyst just before vitrification can have a positive effect on the survival after~     warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has~     shown a similar survival rate but an increase in the implantation rate of collapsed~     blastocysts compared to non-collapsed blastocysts.~      The aim of the study is to investigate the effect of artificial shrinkage by laser-induced~     collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage~     embryos in a prospective randomised controlled trial.~   "
82295|NCT01980212|"~     In pre-clinical study we found that the thioredoxin reductase activity of serum harbours~     huge difference between cancer patients and non-cancer patients, the enzyme activity~     elevated remarkably among cancer patients, and after any kind of treatment serum thioredoxin~     reductase activity declined remarkably, so we hypothesis that serum thioredoxin reductase~     activity could be a warning marker for early progression of first-line treatment for~     advanced non-small cell lung cancer~   "
82296|NCT01980199|"~     This study is designed to determine the efficacy of Fexinidazole as an oral treatment in~     Visceral Leishmanisasis sudanese adults patients.~      The results of this proof of concept study will allow to make a decision on whether to~     proceed with clinical development of Fexinidazole for visceral leishmaniasis.~   "
82297|NCT01980186|"~     This study will use linear 2D ultrasound imaging to look at the brain of individuals~     diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It~     is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain~     and will further allow the imagining of brain areas important to language and social~     function.~   "
82298|NCT01980173|"~     This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone~     therapy. Included patients are randomized to two arms: the Sulprostone + Bakri balloon arm~     versus the Sulprostone alone arm.~      The main objective of this study is to compare the efficiency of a care strategy including~     the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence~     study juxtaposing costs and the necessity of invasive procedures (arterial embolization,~     ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum~     hemorrhage.~   "
82299|NCT01980160|"~     The primary study hypotheses are that, without increasing doses of breakthrough medications~     or device intolerance, the Nometex™ device worn for 5-days beginning with the day of~     chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer~     will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce~     the severity of nausea.~      The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes,~     day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without~     increasing doses of breakthrough medications or device intolerance.~   "
82300|NCT01980147|"~     Severe mental illness such as schizophrenia and mood disorders typically develops at a young~     age and can cause life-long disability. Currently available treatments cannot cure severe~     mental illness. This makes it important to find ways to prevent severe mental illness in~     young people before it has a chance to develop. This research study will pilot a new~     preventive intervention for young people who are at high risk of developing severe mental~     illness. The investigators will target early preceding factors (the 'antecedents') to severe~     mental illness which includes anxiety, unusual hearing and visual experiences, the loss of~     previously acquired abilities, and sudden and unpredictable changes in mood. These~     antecedents strongly predict an increased risk of developing severe mental illness. They are~     often impairing and distressing to the individual but can be improved with self-management~     skills and parent training, and they are present in the individual years before the onset of~     severe mental illness which makes them an ideal target for early intervention. The goal is~     to intervene early enough in the young person's life that severe mental illness can be~     prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators~     want to test the acceptability and short-term efficacy of this new preventive intervention.~   "
82301|NCT01980134|"~     To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive~     colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even~     left in-situ) without adverse clinical impact.~   "
82302|NCT01980121|"~     Food residue in the stomach of patients scheduled to have surgery is considered a major risk~     factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise~     after aspiration is associated with significant morbidity and mortality. The risk of~     pulmonary aspiration is especially important in pregnant women, as they may often require~     surgery without having observed appropriate fasting. In pregnant patients scheduled for~     elective surgery, standard preoperative guidelines apply as the general non-pregnant~     surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A~     bedside ultrasound assessment of the status of the gastric content and volume would be of~     great value for the clinician. This technique has recently been shown very promising in~     fasted non-pregnant patients scheduled for elective surgery. Therefore, it is important to~     study its feasibility in the pregnant population scheduled for elective Cesarean Delivery.~      The investigators hypothesize that no residual solid contents will be found in the gastric~     sonography, and a small volume of gastric fluid will be observed in the antrum in both~     supine and right lateral decubitus.~   "
82303|NCT01980108|"~     Solid food or fluid residue in the stomach is always a major concern when patients need~     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary~     aspiration of the stomach contents. This is especially important in emergency procedures,~     when a fasting period is not observed. The aspiration of the stomach contents into one's~     lungs can lead to serious complications (such as severe respiratory failure). Information~     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide~     whether or not it's safe to proceed, cancel or delay a surgical procedure.~      The investigotrs hypothesize that a mathematical model can be constructed to predict clear~     fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in~     healthy adult volunteers.~   "
82307|NCT01980056|"~     Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of~     vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS,~     (< 20% blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO)~     classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by~     the International Scoring System (IPSS) after failure of hypomethylating agent-based~     therapy. Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be~     safe and will effective in this patient population.~   "
82308|NCT01980043|"~     The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal~     prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum~     with sutures to the abdominal wall under needlescopic control. Further, investigators will~     evaluate the short and long-term clinical outcomes after this novel approach to treating~     rectal prolapse.~   "
82309|NCT01980030|"~     This is a Phase I/II multicenter study which aims to assess the toxicity profile of~     Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.~      A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT~     will be included.~      The main endpoint is the incidence and severity of adverse events.~   "
82310|NCT01980017|"~     The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of~     T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely~     to develop a number of health related complications. Community-based diabetes education~     programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence~     to oral medications, insulin therapy, nutrition management, regular blood glucose~     monitoring, and physical activity); however, specific assistance for smoking cessation is~     rarely provided. Our investigative team has developed a knowledge transfer and practice~     change process to introduce evidence-based interventions for smoking cessation into clinical~     practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC).~     Investigators believe there is an opportunity to use the OMSC intervention to dramatically~     enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM,~     and in so doing, improve quit rates in this high risk population.~      The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking~     Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A~     two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a~     consecutive sample of eligible smoker-patients will be recruited from each DEP over a~     6-month recruitment period. Investigators want to test the impact of the OMSC intervention~     on quit rates among smokers with diabetes and pre-diabetes referred to these programs.~     Investigators will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These~     sites will be matched based on number of annual referrals for diabetes education (≤ 500/year~     or > 500/year). Within each pair, sites will be allocated randomly to either OMSC~     intervention or control group. Following randomization, the OMSC program will be implemented~     at the intervention sites over a 6-month period. Following the implementation period, a~     consecutive sample of smokers will be recruited from both OMSC intervention and control DEPs~     over a 6-month recruitment period. It is estimated that this will yield a sample of~     approximately 445 smokers in each of the OMSC intervention and control groups. The primary~     outcome will be the biochemically-validated 7-day point prevalence abstinence rate six~     months after an index visit to the DEP. Secondary outcomes will include: rates of~     identification and intervention of smokers, and diabetes educators' attitudes, confidence,~     and perceptions of barriers and facilitators to implementing smoking cessation support as~     part of routine care.~      If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and~     could have profound impacts on patient and community health.~   "
82311|NCT01980004|"~     The purpose of this study is to compare the role of potassium citrate supplementation with~     dietary education versus dietary education alone in the reduction of stone risks and events~     in patients with predominantly calcium phosphate kidney stones.~   "
82312|NCT01979991|"~     To develop a computer program that will improve CT image quality and decrease the amount of~     x-ray radiation that future patients may be exposed to when they have a CT examination.~   "
82313|NCT01979978|"~     School-based interventions are generally ineffective for preventing weight gain in children.~     In 2007, a group from the University of British Columbia, developed a program called Healthy~     Buddies, that relied on peer mentors to help young children adopt healthy living behaviours.~     Pilot studies revealed that the program effectively prevented weight gain in children. This~     trial had never been tested on a large scale using a more scientifically sound study design.~     We developed a large school-based randomized trial to overcome that limitation and test the~     hypothesis that that a school-based peer-led healthy living program would reduce adiposity~     and increase physical activity among children 6-12yrs old.~   "
82314|NCT01979965|"~     The purpose of this study is to find out whether mitral regurgitation (or a leaky heart~     valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve~     after administration of ranolazine.~   "
82315|NCT01979952|"~     This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind~     clinical trial followed by conversion of each arm to active nintedanib for an additional 6~     months comparing the effect of nintedanib 150mg BID on the progression of IPF measured by~     using HRCT, lung function, 6MWT, biomarkers, and PROs with continued treatment and~     assessments for up to 18 months.~   "
82316|NCT01979939|"~     To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and~     treatment experienced non-cirrhotic subjects~   "
82317|NCT01979926|"~     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the~     Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With~     acute and acute exacerbation of chronic bronchitis for 7 days.~   "
82318|NCT01979913|"~     Increased intraocular pressure (IOP) has been identified as the most important risk factor~     for the development and the progression of glaucoma. Data from large interventional studies~     have shown that a decrease of IOP is associated with a reduced risk of progression of the~     disease. This underlines the importance of a potent and save IOP lowering therapy. The~     introduction of preservative free tafluprost offers a new treatment possibility using a~     potent topical prostaglandin analogue without the disadvantages of a co-administered~     preservative. The current study seeks to investigate the effect of an 8 week therapy with~     preservative free tafluprost on intraocular pressure in patients with ocular hypertension or~     primary open angle glaucoma having an IOP of 30 mmHg or more.~   "
82329|NCT01979770|"~     This study aims to investigate the relationship of the various exposures during infancy and~     childhood on later health and development of adolescents. Various exposures to be assessed~     include, but not limit to, nutritional status, body composition, energy expenditure, dietary~     intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.~      The study will specifically aim to respond these research questions:~      1.1 What are the factors associated with overweight, obesity, and stunted in adolescents?~     1.2 What are the factors associated with increased risk of NCDs during adolescence? 1.3 What~     are the factors associated with cognitive functioning during adolescence? Since numerous~     variables were collected, additional research questions can be possibly studied or other~     interested variables can be included in the future.~   "
82319|NCT01979900|"~     Mycobacterium Vaccae for Injection (Trade Name Vaccae) is a kind of bio-products developed~     by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got The New Drug Certificate in~     1999. Vaccae has been approved for adjuvant therapy of tuberculosis(TB), and is also the~     only recommended drug in TB immunotherapy by WHO. It was approved for production and sale by~     Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd. in 2001, and got favourable comment in~     therapy of tuberculosis.~      The purpose of this study is to add new indications for Vaccae, mainly to prevent~     Tuberculosis for high risk groups of Tuberculosis Infection . In December 2012, China Food~     and Drug Administration approved of the plan Phase III Clinical Study of Efficacy and~     Safety of Mycobacterium Vaccae to Prevent Tuberculosis in high risk groups of Tuberculosis~     Infection. In the test, 10,000 cases whose skin tests of PPD are strongly positive are~     enrolled. Using random, double-blind, and placebo-controlled methods, the study is carried~     out to evaluate the efficacy and safety of Vaccae in preventing Tuberculosis. Meanwhile, in~     this test, TB incidence and degree of pathological changes of experimental group are lower~     than that of control group, and no drug-related SAEs are reported in treatment groups.~   "
82320|NCT01979887|"~     This is an exploratory study to evaluate endpoints used to characterize participants with~     and without meibomian gland dysfunction (MGD) and will evaluate the correlation between~     signs and symptoms of MGD. No investigational drug will be administered in this study.~   "
82321|NCT01979874|"~     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral~     supplementation will improve systemic inflammation, vascular function, and symptomatic~     status of patients with PAD. Investigators will explore novel mechanistic pathways by which~     n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the~     resolution of inflammation.~   "
82322|NCT01979861|"~     The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation~     is safe and effective for reducing menstrual blood loss in women with excessive uterine~     bleeding (menorrhagia)~   "
82323|NCT01979848|"~     Urinary incontinence and sexual dysfunction are potential side effects for men undergoing~     the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the~     investigational Endorectal Cooling Balloon has been shown by our group to significantly~     reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic~     prostatectomy, and improve the patient's long term quality of life (QOL). However before~     successful translation of the endorectal balloon can proceed into the world wide usage, we~     must understand:~        1. How effectively the tissues for continence and sexual function are cooled within the~          pelvis.~        2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to~          'cool sink' or diminish the effective cooling and~        3. Determine if the endorectal balloon can be re‐designed for improved QOL outcomes in~          men.~      This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling~     for prostate cancer surgery. MRI is non‐invasive. A simple confirmation of effective~     hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as~     it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with~     temperature adaptive software can accurately map these gradients with non‐invasive~     technique, and answer formidable questions of the effectiveness of hypothermic cooling of~     the prostate and its direct translation into improved continence and sexual function after~     surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and~     Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to~     help further understand how the cooling balloon works, which may translate to other uses in~     the future, including the diagnosis of patients at a high risk of developing prostate~     cancer.~   "
82324|NCT01979835|"~     The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The~     GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the~     GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by~     reducing failed insertions and perforations. We now need to know how easy it is for doctors~     to see and measure the distance of the anchor to the outside of the uterus. The purpose of~     this open, prospective, observational study is to assess the feasibility of measuring the~     distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz~     and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of~     insertion, the acceptability of the device to Canadian women and any complications. We will~     also compare expulsion rates in post-abortion and other women.~   "
82325|NCT01979822|"~     The clinical study aims to investigate the numbers of predefined complications in the first~     six month after implantation of the implantable LENUS Pro® medications pump for intravenous~     application of treprostinil sodium in patients with PAH.~      The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH & Co KG~     78665 Frittlingen, Germany.~   "
82326|NCT01979809|"~     The purpose of this study is to conduct a two site, three arm randomized intervention study~     to improve fruit and vegetable intake, improve whole grain intake and reduce sweetened~     beverages in young adults aged 21 to 30 years. This work is potentially very high impact in~     light of growing overweight and obesity and decreased health status overall, and potential~     dietary benefits to children of our target age group.~   "
82327|NCT01979796|"~     It is well established in studies across several countries that tobacco smoking is more~     prevalent among schizophrenic patients than the general population. Electronic cigarettes~     (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are~     no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial~     is needed to compare efficacy and safety of these products in this special population.~   "
82328|NCT01979783|"~     Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key~     role in stability of the lumbosacral spine. The muscles' functional and/or structural~     deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus~     abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not~     well defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a~     method of examining muscles function, is not involved in clinical routine. Rehabilitative~     Ultrasound Imaging (RUSI) of the TrA and LM, apart from providing information about their~     morphology, could be helpful in assessing their function. Since concentric muscle~     contraction results in the shortening and thickening of the muscle, evaluation of the~     potential association between muscle's morphometry, assessed by the ultrasound, and~     electromyography, may be of potential clinical interest. However, this potential~     relationship is context-dependant. Our aim was to establish the difference in the thickness~     change of the TrA and LM muscle during activation in subjects with and without low back~     pain, and to establish the possible correlation between electromyography and the thickness~     change of these muscles assessed by ultrasound in both groups of subjects.~   "
82339|NCT01979640|"~     The purpose of this study is to find the adequate additional bronchial cuff volume after~     achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood~     through cuff) in double lumen tube~   "
82330|NCT01979757|"~     Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity.~     Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized~     technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics,~     USA) is a new method that involves washing and filtering the fat to prepare the graft. The~     investigators compared the subjective and objective outcomes of two fat-processing methods,~     centrifugation and PureGraft filtration.~      Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT~     in our department between April 2011 and September 2012. The patients were preoperatively~     divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15~     received fatgrafts processed by washing in PureGraft bags. The patients were followed up for~     12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q~     questionnaire to all the patients both preoperatively and one year postoperatively. The~     BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.~   "
82331|NCT01979744|"~     Although first generation DES reduced instent restenosis, still remained the unsolved~     problems such as stent thrombosis and restenosis in the era of DES. Second generation DES~     had been developed to improve the biocompatibility of stent coating focused on polymer~     compared to first generation DES, so that second generation stents showed better outcomes~     compared with first generation DES. On the other hands, in third generation DES, further~     refinement of DES involved more flexible stent platform. Promus ElementTM (Everolimus~     eluting stent, Boston Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting~     stent, Medtronic Vascular, Santa Rosa, CA) are the third generation drug eluting stents~     which are designed to increase flexibility. In previous randomized controlled studies, both~     of these stents have shown at least non-inferior angiographic and clinical outcomes compared~     to second generation DES. However, there is lack of data about comparison of angiographic~     and clinical outcomes between Promus ElementTM and Resolute Integrity®.~      IVUS is one of the widely used intracoronary imaging devices to provide more reproducible~     and accurate information about coronary anatomy than angiography in current practice.8~     Optimal stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an~     important factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been~     many studies to evaluate the procedural or clinical benefit of IVUS guided angioplasty.~     However, The clinical benefit of IVUS-guided angioplasty with stent implantation is still in~     a controversy. In the previous studies, IVUS-guided stent implantation showed positive or~     negative beneficial effect on clinical outcomes according to their study subjects. However,~     the stents used in the previous studies are less useful in current practice of cardiology~     and there is lack of data of 3rd generation DES, which have different stent profiles and~     outcomes with their predecessors.~      Thus we would perform a prospective randomized study in order to compare the efficacy of~     IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary~     lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long~     coronary lesions would have better clinical outcomes compared with conventional~     angiography-guided strategy. We also intend to assess the clinical outcomes after Promus~     ElementTM and Resolute Integrity® implantation.~   "
82332|NCT01979731|"~     The objective this study is evaluated if job rotation (change works that function every to~     work hours)contributes to reduce absence from work to complaints musculoskeletal disorders.~     And:~        -  Improve general health status~        -  Improve musculoskelettal symptoms~        -  Improve work performance~        -  Decrease costs with absence~   "
82333|NCT01979718|"~     It was well known that the mirror therapy could decrease pain of upper-limb amputated~     patients.~      The mirror therapy is known to make a plastic change some parts of the brain perceiving the~     painful body part and modulating its signal by feedback of visual information mirrored with~     the corresponding contra-lateral normal parts.~      In this study, post-operative analgesic efficiency of the virtual reality using a mirror~     therapy after total knee arthroplasty will be evaluated.~      This clinical trial will be performed in the form of prospective, single-blind (i.e.~     assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.~   "
82334|NCT01979705|"~     Infectious disease is the single biggest cause of death worldwide. New infectious~     agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of~     influenza continually emerge and require new investigations to understand pathogen biology~     and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses~     and their impact on health and the economy are also increasing. Current alerts sent out by~     the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but~     cases in point. These likely reflect advances in science, which have allowed novel pathogens~     to be identified.~      Because of its geography, Singapore is vulnerable to new pathogens through importation or~     the global travel of its citizens. Hence we must be ever ready to meet unexpected challenges~     anytime.~      On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force~     which has in place many plans that can be activated should there be a large-scale epidemic.~      What is missing thus far is a program that will enable us to perform scientific studies in~     the setting of an epidemic. Hence in this study, we will, in collaboration with the Program~     in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate~     Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii)~     characterize viruses (not necessarily novel but emerging and re-emerging) that are raising~     concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize~     immune responses to such viruses in healthcare workers as well as patients (those affected~     by these viruses and those exposed to the affected). The techniques that will be used will~     be those not routinely available in a hospital's service labs.~      Some patients will remain undiagnosable with the best available technology. Since new~     laboratory tools that can detect previously undiagnosed pathogens may become available in~     the future, the study also aims to archive specimens from patients whose illnesses remain~     undiagnosed.~   "
82335|NCT01979692|"~     The hypothesis of this proposal is that needle confocal laser microscopy (nCLM) may improve~     the yield of trans thoracic needle biopsy (TTNB) of lung or mediastinal lesions by~     differentiating between viable and necrotic tissue. This may reduce the number of biopsy~     attempts and eventually the complication rate of the procedure.~   "
82336|NCT01979679|"~     The purpose of this research study is to measure how many of the dopamine receptors~     lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective~     disorder and over what time period the occupancy occurs. This is research because lurasidone~     is an investigational medication that has not yet been approved by the Food and Drug~     Administration (FDA). Dopamine receptors have key roles in many processes, including the~     control of motivation, learning, and fine motor movement. The degree of occupancy and the~     transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent~     relapses is a controversial area that this study will address.~      In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3~     ligand 18F-fallypride (a radioactive, injectable substance) to help the researchers measure~     the use of these receptors. Researchers hope that quantifying the amount of receptors being~     occupied by the medication will help them to determine the best dose of study medication in~     terms of improvement and least side effects related to body size and gender as well as in~     preventing relapse that may be related to hypersensitivity. Magnetic Resonance Imaging~     (fMRI) will also be performed. MRI is a scanning method which makes pictures of parts of the~     brain using a large magnetic field. This study will use a particular kind of MRI called~     fMRI, or functional MRI. fMRI takes pictures of the brain while the person is thinking or~     doing a simple task. fMRI will allow the researchers to investigate patients regional brain~     activation during cognitive (mental) and emotional tasks.~   "
82375|NCT01979172|"~     The study aims at determining the best biometry calculation formula to be used in IOL~     calculation of cataract patients how previously underwent laser refractive correction~     surgery~   "
82340|NCT01979627|"~     The transradial approach for coronary angiography and angioplasty is now widely used in~     catheterization laboratories worldwide, which had been shown as advantages over the~     conventional femoral and brachial approaches due to the lower incidence of bleeding and~     other cardiovascular complications. However, the transradial approach does not seem suitable~     for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery~     which is one of the two terminal branches of the brachial artery is usually larger than~     radial artery and it may be as a potential approach for cardiac catheterization. Recently,~     some reports have demonstrated that the transulnar approach may be both feasible and safe~     for coronary angiography and angioplasty in selective patients.we performed this study to~     evaluate the safety and feasibility of transulnar approach coronary catheterization in real~     world non-selective patients.~   "
82341|NCT01979614|"~     This is a mechanistic study in patients with coronary artery disease on the effects of~     Serelaxin on micro- and macrovascular function.~   "
82342|NCT01979601|"~     This study is designed to measure the effects of LGT209 when given intravenously to patients~     with high cholesterol who are on stable doses of statin medications, and to healthy subjects~     with elevated cholesterol~   "
82343|NCT01979588|"~     Previous work has shown that the epidemiological context of a patient's presentation can~     provide important information for clinicians to aid in diagnosis and treatment. With current~     electronic health records, it is increasingly possible to perform syndromic surveillance~     that is local and specific to a patient's characteristics.~      The investigators have developed algorithms for syndromic surveillance for a number of~     conditions in which contextual information might be of use to treating clinicians. The~     syndromic surveillance algorithms already developed are for influenza-like-illness, whooping~     cough, asthma exacerbation, Group A Streptococcal pharyngitis, and gastroenteritis~     infection.~      The investigators plan on studying these tools with a clustered randomized control cohort~     study evaluating how clinical decision making is affected by use of these tools by~     outpatient general practitioners. The goal is to incorporate these validated algorithms into~     a quality improvement tool which will provide point-of-care clinical decision support to~     clinicians~   "
82344|NCT01979575|"~     1) Observe the hemodynamic and cardiovascular changes associated with the change from the~     supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular~     changes during intra-abdominal insufflation used during laparoscopic surgical procedures.~   "
82345|NCT01979562|"~     The purpose of this study is to examine the skeleton of the legs and the running style in~     order to predict a possible overuse injury.~   "
82346|NCT01979549|"~     The primary objective is to investigate the adverse events during upper gastrointestinal~     endoscopy with and without sedation in Chinese population~   "
82347|NCT01979536|"~     This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib~     and combination chemotherapy works in treating patients with newly diagnosed stage II-IV~     anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab~     vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib~     and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. It is not yet known whether brentuximab vedotin and combination~     chemotherapy is more effective than crizotinib and combination chemotherapy in treating~     anaplastic large cell lymphoma.~   "
82348|NCT01979523|"~     This randomized phase II trial studies how well trametinib with or without Akt inhibitor~     GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to~     other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     trametinib is more effective with or without GSK2141795 in treating patients with metastatic~     uveal melanoma.~   "
82349|NCT01979510|"~     The primary objective of this study is to evaluate the safety and tolerability of MK-0663B~     (etoricoxib/tizanidine) among participants with moderate-to-severe acute low back pain.~   "
82350|NCT01979497|"~     To determine whether the addition of adhesive stripping to a wound closed with dermal~     sutures improves outcome of wound closure. We hypothesize that the combination of adhesive~     strips to a wound closed with dermal sutures does not add significant cosmetic improvement~     of the resultant scar.~   "
82351|NCT01979484|"~     This study will compare the blood levels of PPI-668 resulting from two different~     formulations - the current capsule and a new tablet.~   "
82352|NCT01979471|"~     Cardiovascular disease (disease of the heart and blood vessels) is one of the leading causes~     of death in Canada. It also carries a financial burden on the Canadian economy with a yearly~     cost close to $21 billion divided between loss of productivity and healthcare costs. The~     majority of cardiovascular disease cases (90%) are caused by factors that can be controlled~     and modified. These factors include high blood pressure, high cholesterol, diabetes (high~     blood sugar), tobacco smoking, unhealthy diet, obesity, physical inactivity and high alcohol~     consumption. Such factors are very common and not very well controlled and so individuals~     who have any of these factors would be at risk of having cardiovascular disease. As such~     controlling these factors will reduce the risk of having cardiovascular disease and improve~     the individuals' quality of life. Pharmacists frequently work with patients and their family~     doctor to provide cardiovascular care. Having a pharmacist involved in cardiovascular care~     may help patients with cardiovascular disease or at risk of having the disease because they~     are more accessible and may have more opportunities to educate people about cardiovascular~     medications. This might lead to better prevention and control of cardiovascular disease.~      Purpose:~      The research study will assess if a community pharmacy cardiovascular risk reduction~     intervention can help reduce cardiovascular risk.~      Procedure:~      If the individual has an elevated blood pressure, cholesterol, blood sugar, waist~     circumference or body weight or is physically inactive, have an unhealthy diet, a smoker or~     taking medications for any of the previously mentioned conditions, the pharmacist will~     assess the cardiovascular disease risk [risk of having a cardiovascular event (e.g. heart~     attack or a stroke)] using a computer program. If the individual is at high risk s/he will~     be asked to take part in the study.~      If the individual agrees to take part in the study s/he will be randomly assigned to either~     the Usual Care Group or the Advanced Care Group. All participants have an equal chance of~     being assigned to either group. If assigned to the Usual Care Group, the individual will~     receive the care and services that would normally be provided by the pharmacist. At 3~     months, the pharmacist will see the individual who will be offered the Advanced Care at that~     time.~      If assigned to the to Advanced Care Group, the individual will be asked to meet with the~     pharmacist every 3-4 weeks over a 3 month period. During these meetings, the pharmacist will~     conduct an assessment that may include blood pressure, waist circumference, height and~     weight measurements and talk to the individual about their cardiovascular risk and~     medications. The individual and the pharmacist will come up with a plan for how to try to~     lower his/her cardiovascular risk. The pharmacist will discuss this plan with their family~     doctor. The individual will be asked to conduct some laboratory tests before the 3 months~     visit; these tests may include HbA1c (a blood test to measure blood sugar control over the~     last 3 months) and cholesterol to assess the effect of the intervention on cardiovascular~     risk.~   "
82353|NCT01979458|"~     The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic~     imaging technique. Specifically, topographical surface contrast reconstructed from the PSE~     data will be compared to conventional imaging contrast to assess if PSE provides enhanced~     contrast of abnormal tissue.~   "
82354|NCT01979445|"~     There are two separate objectives in this study:~        1. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are~          switched to oral prasugrel administered 30 min after cangrelor infusion is discontinued~          and~        2. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are~          switched to clopidogrel 600mg administered during or immediately after the infusion.~   "
82355|NCT01979432|"~     The main objective of this study is to look for the interest forecast of the IPS as~     infra-clinical cardiovascular marker in the prediction of a change of the cognitive~     functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular~     pathology.~   "
82356|NCT01979419|"~     PRIMARY OBJECTIVES~      -Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular~     dementia (SIVD)~      STUDY DESIGN~      -This is a non-randomized, natural history, observational, registry study.~      SAMPLE SIZE AND RECRUITMENT~      - Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with~     AD, 100 with vMCI, and 100 with SIVD)~      SUMMARY OF KEY ELIGIBILITY CRITERIA~        -  Newly enrolled subjects will be between 50-80 (inclusive) years of age.~        -  1) Cognitively Normal Subjects~        -  2) MCI subjects~        -  3) AD subjects~        -  4) vMCI or SIVD~      PROCEDURES~        -  Recruited subjects will have clinical/cognitive assessments, biomarker and genetic~          sample collection, and imaging.~        -  Subjects will be followed up for 36 months from the baseline visit. All assessments are~          to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and~          amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit.~          2) CSF collection will also be performed on baseline and at 24 months visit. 3)~          Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months~          from baseline to determine short term change.~      OUTCOME MEASURES~        -  Group differences for each clinical, cognitive, biochemical, and imaging measurement.~        -  Rate of conversion or change of disease severity will be evaluated among all groups~        -  Correlations among biomarkers and biomarker changes~   "
82357|NCT01979406|"~     The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to~     the positive (vaccine) control as studied in normal healthy volunteers.~   "
82358|NCT01979393|"~     This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs~     that have effects on tumour growth, blood supply, invasion and spread.~      Therefore, we want to find out whether taking cabozantinib after treatment with surgery and~     chemotherapy is effective and safe for patients who responded or had stable disease after~     their chemotherapy.~      All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization~     or response to the standard chemotherapy will be split into 2 groups (cabozantinib or~     placebo).~   "
82359|NCT01979380|"~     To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male~     subjects~      To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male~     subjects~      To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy~     male subjects~   "
82360|NCT01979367|"~     To evaluate the efficacy treatment of lower extremity pathologies derived from neurological~     ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and~     Transcutaneous Electrical Nerve Stimulation (TENS) therapies.~   "
82361|NCT01979354|"~     Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating.~     Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control~     group in term of analgesia.~   "
82362|NCT01979341|"~     The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH~     agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger~     has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its~     sole use results in reduced embryo implantation due to luteal phase insufficiency. The~     combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been~     shown to overcome the luteal phase insufficiency effecting endometrial receptivity.~      In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg~     Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in~     normoresponders will increase oocyte maturity, embryo quality and embryo implantation and~     reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose)~     alone trigger.~   "
82363|NCT01979328|"~     The primary objective of this study is to examine the flow characteristics of deep venous~     flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the~     application of a plaster and with a geko™ device in healthy volunteers~   "
82364|NCT01979315|"~     Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully~     understood.Increased pain sensitivity in the primary area of pain (local pain) is considered~     a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low~     back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas~     is considered to present a more central phenomenon. It is suggested that pat ents with~     enhanced pain sensitivity report high level of disability. Despite fact that pain and~     disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in~     LBP disability is unknown. It has also been suggested that muscle function changes may be~     driven by pain. The possible role and contribution of trunk muscles function to pain and~     disability phenomena remain unknown.~      This study was aimed to estimate prevalence and possible correlation among pain~     hypersensitivity and functional and electromyography parameters of trunk muscles in patients~     reporting early phase of chronic LBP.~   "
82365|NCT01979302|"~     Depression in older home healthcare patients occurs very often, is typically not treated~     appropriately, and leads to poor health outcomes. This study tests an intervention, called~     Depression Care for Patients at Home or the Depression CAREPATH, designed to help home~     healthcare nurses work with the patients, their family, and their doctors in managing~     depression treat depression according to clinical guidelines and to manage its treatment~     over time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent~     changes in depression treatment and reduction in depressive symptoms.~   "
82560|NCT01976754|"~     Septic patients in Intensive Care Unit always need mechanical ventilation and~     conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of~     wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult~     septic patients of mechanical ventilation .~   "
82366|NCT01979289|"~     This research study will examine if a targeted computerized cognitive remediation (CCR)~     training program is better for treating geriatric depression than general computer activity.~     We will also examine whether this intervention is related to improvement in cognitive and~     depressive symptoms. Elderly patients with depression, who have, and who have not been~     treated with antidepressant medication for their illness, will be recruited to participate~     in either a 30 hour cognitive remediation program or general computer activity designed to~     be both challenging and interesting. They will be asked to complete between 1 and 3 hours of~     remediation per day over 4 weeks. While undergoing the cognitive remediation participants~     will be asked questions to assess their symptoms of, as well as the severity of, their~     depression weekly. This will inform researchers about whether or not the CCR is helping to~     improve depressive symptoms. At the end of the CCR study, participants will be given a~     battery of cognitive tests design to tell investigators whether or not the CCR improved~     their thinking in a variety of different ways including improving attention, memory, and~     organization. Investigators will also determine whether changes in participants' thinking~     are related to changes in their mood or other depressive symptoms. It is hoped that~     information gained from this study will help investigators to better understand the brain~     processes associated with depression, recovery from depression, and will help inform the~     development of future alternative treatments for this illness.~   "
82367|NCT01979276|"~     This clinical trial is for subjects with multiple myeloma that has returned after treatment~     (relapsed) or did not respond to prior treatment (refractory). The study is in two parts,~     Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in~     combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the~     effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is~     that overall response in a cohort of patients treated with romidepsin + pomalidomide +~     dexamethasone will be 60 percent.~   "
82368|NCT01979263|"~     The purpose of this project is to study the feasibility and efficacy of attention bias~     modification treatment (ABMT) in a randomized-controlled sample of anxious youth.~   "
82369|NCT01979250|"~     Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is~     characterized by changes on the inside of the cornea, which leads to a substantial decline~     in visual acuity. The only effective treatment option for Fuchs' ED is corneal~     transplantation.~      Corneal transplantation Corneal transplantation surgery has seen major advances in the last~     decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure~     has now become the preferred method.~      Outcome There have been a substantial number of publications on outcome after DSAEK surgery,~     and the procedure has several advantages over the former preferred method of~     transplantation, penetrating keratoplasty (PK).~      Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored~     even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far~     results have been conflicting.~      Hypotheses~        1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs'~          endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and~          the type and magnitude of optical disrupting guttae in Descemet's membrane.~        2. The subjective visual function after corneal transplantation with a posterior lamellar~          graft is correlated with the optical properties of the grafted cornea (thickness, light~          scatter, irregularities on the anterior, and posterior corneal surfaces)~      Materials and methods~      In a controlled prospective trial of DSAEK patients, we aim to register different~     morphological patterns, monitor visual performance and optical parameters.~      Three sex and age-matched groups will be compared:~      Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined~     cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that~     undergo cataract surgery.~   "
82370|NCT01979237|"~     Shoulder anterior dislocation is a major disease entity in emergency department. There are~     more than 10 reduction methods that have been reported. Traditional reduction methods~     require sedatives, which could cause adverse effects on the patients such as respiratory~     suppression and allergy. There are some reduction maneuvers reported recently which do not~     need sedatives prior to performing reduction, including FARES method and SPASO method. So~     far, there are no well-designed study to compare these two methods. Besides, in clinical~     experience, we found that combining these two methods could even get higher successful~     reduction rate. This study is aimed to compare these two methods as a prospective randomized~     design, and furthermore, to show that combining these two methods could get higher~     successful reduction rate.~   "
82371|NCT01979224|"~     Introduction. Asthma is a chronic inflammatory disorder of the airways, identified by~     airflow obstruction. Unfortunately only 2.4% of American asthmatics meet internationally~     recommended criteria for control. The lack of knowledge in parents of asthmatic children has~     been a direct result of minimum or no control at all, so the educational programs need to be~     assessed in terms of improvement of the control. Target. To determine whether an educational~     intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control~     measured by Test Childhood Asthma Control. Material and Methods. Randomized controlled~     clinical trial in 42 patients randomly divided into two groups that were evaluated in the~     same time knowledge and control of asthma, a measurement was performed at baseline and~     monthly for nine months. The experimental group attended an educational intervention for~     individual reinforcements through this period, the control group was only monitored~   "
82372|NCT01979211|"~     The standard treatment of surgery followed by radiation therapy can stop tumors from growing~     in the head and neck region in most patients. However, the cancer can recur or can spread to~     other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by~     blocking certain cellular chemical pathways that lead to tumor development. It was approved~     by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head~     and neck cancer.~      The purpose of this study is to determine how easily cetuximab can be added to treatment~     with radiation therapy in patients with cutaneous cancer of the head and neck. This study~     will also look at how well cetuximab added to radiation therapy works over time and how well~     this treatment is tolerated.~   "
82373|NCT01979198|"~     The surgical results of thoracolumbar and lumbar burst fracture have been reported to be~     comparable between patients with and without fusion in a midterm follow-up. There is,~     however, no report comparing the results of fusion and non-fusion with a long-term~     follow-up. Therefore, a long term comparative study is still needed to focus on the issues~     of functional and radiographic outcomes, especially preservation of the motion segment in~     the long run, to determine whether fusion should be a routine procedure for surgically~     treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein~     a long-term comparative study of fusion and non-fusion based on our previous work, with an~     average 134 months of follow-up.~   "
82374|NCT01979185|"~     This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184~     on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.~   "
82376|NCT01979159|"~     In order to determine if speech-language therapy has positive effect, reliable measurement~     tools are required to document outcomes. Currently, there is very limited information~     concerning the measurement of changes in speech production as a result of treatment for~     acquired apraxia of speech and aphasia. This study will obtain information concerning the~     reliability of several speech production measures over time. Thirty persons with chronic~     aphasia and apraxia of speech will be asked to provide speech samples in response to~     commonly used assessment tools on three sampling occasions so that the stability of~     measurements may be examined.~      After establishment of appropriate outcome measures, a small, pilot treatment study will be~     conducted with four participants. The participants will receive a new treatment for aphasia~     and acquired apraxia of speech and outcomes will be measured relative to speech and language~     production.~   "
82377|NCT01979146|"~     The purpose of this study was to test the efficacy of a computer-based automated symptom~     monitoring telephone system used by patients who received chemotherapy for their cancer to~     communicate unrelieved symptoms they experienced to their oncology providers. The symptoms~     monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation,~     depressed mood, anxiety, trouble sleeping, and fatigue. The study randomly assigned~     participants into either the intervention group or the group that received usual care from~     their oncology providers without alert notifications. All participants called the automated~     system daily to report their symptom presence, severity, and distress. When participants in~     the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail~     alert report of their symptom information was sent to the participant's medical oncologist~     and oncology nurse. The usual care group also reported symptoms daily to the automated~     system but their information was not sent to the providers. Participants in the usual care~     group were told daily to call their oncology provider if they had concerns about their~     symptoms. The two study groups were compared over chemotherapy cycles 2 and 3 on symptom~     presence, severity, and distress. Functional status, patient reported degree of symptom~     interference with normal activities, and work attendance if they had indicated that they~     worked during their treatment were also recorded. In addition, the groups were compared for~     the number and purpose of unscheduled patient-provider contacts, visits to the emergency~     department or urgent care facility, and unscheduled hospitalizations.~   "
82378|NCT01979133|"~     This study is being done to see if icariin will help with depression in patients with~     bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain~     20% icariin.~   "
82379|NCT01979120|"~     A prospective observational multi-centre study for the validation of the ApneaScan algorithm~     (integrated in ICD devices (with or without cardiac resynchronization therapy function) of~     the Incepta series for the screening of sleep disordered breathing in patients with stable~     symptomatic chronic heart failure, using portable polygraphy monitoring device (Embletta~     Gold) as reference for the Apnea-Hypopnea-Index (AHI).~      Secondary objectives are the detection of severe sleep disordered breathing in patients with~     clinically indicated in-laboratory polysomnography, as well as correlations of the AHI~     detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial~     fibrillation and ventricular arrhythmia.~   "
82380|NCT01979107|"~     In this randomized controlled study it is investigated if a proactive action by the general~     practitioner offering individuals without formal education a preventive health check will~     lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease,~     cardiovascular diseases, and diabetes among participants in the intervention group compared~     to the control group. Furthermore it will be investigated if the proactive action by the~     general practitioner will be associated with a higher smoking cessation rate at 12 month~     follow-up.~   "
82381|NCT01979094|"~     To collect and organize data into a repository for future research.~   "
82382|NCT01979081|"~     The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure~     that assesses preclinical disability. Preclinical disability is a functional state in which~     people are still able to complete daily living tasks (e.g., walking, bathing) but are~     changing the frequency or modifying the way that they complete the tasks. The investigators~     have done some preliminary research using the PFI as an online monitoring tool (Richardson~     2012), but further study is required to examine its psychometric properties and its~     suitability for use as a primary outcome measure. This measurement study has been designed~     to identify the optimal number of items on the PFI and to determine the reliability,~     validity, and responsiveness of the PFI when administered to a sample of adults and older~     adults both with and without chronic conditions. This project will also allow us to evaluate~     the use of self-monitoring of physical function and the added value of rehabilitation~     professionals to support self-monitoring. Using the results of the PFI, the investigators~     aim to develop a tailored population-based rehabilitation self-management intervention~     delivered through a secure messaging system in the patient's electronic personal health~     record (myOSCAR) that focuses on the early detection and prevention of preclinical~     disability.~   "
82383|NCT01979068|"~     -  Vascular Inflammation is a key factor in both the pathogenesis and outcome of~          atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying~          vascular inflammation within atherosclerotic plaque~        -  Recently, unique subsets of obese individuals, such as metabolically obese but normal~          weight (MONW) and metabolically healthy obese (MHO), have been getting an attention~        -  Therefore, the purpose of this study is to examine the relationship of vascular~          inflammation,measured by FDG-PET, with various body sized phenotypes~   "
82406|NCT01978769|"~     In the current study we will examine a specific aspect of these processes that has yet to be~     studied. We will test the effect that a physically effortful assignment has on the choices~     that a preadolescent makes using a forced choice paradigm in which the participant will be~     asked to choose between and carry out either a high cost-high reward option (HR) or a low~     cost-low reward (LR) option. The HR option will demand a significant amount of physical~     effort and will be paired up with a large reward as opposed to the LR option which will be~     less demanding physically and paired up with a small reward. The assignment will be carried~     out using a hand held dynamometer which measures the power produced by the participants'~     upper extremity.~      We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a~     task that involves less effort despite the small reward tied to it compared to a control~     child who will choose the more demanding task and the larger reward.~   "
82384|NCT01979055|"~     Asthma in older adults has been overlooked, understudied, and inadequately treated. While~     asthma programs targeting the unique needs of children, teenagers, women, minorities, and~     other populations have been successfully developed, there are currently none for older~     adults. This is particularly distressing as the asthma hospitalization rates, mortality~     rates, quality of life, and control are significantly worse in the elderly as compared to~     other age groups. It is clear that novel approaches are needed to improve the care in this~     population.~      The investigators group has been active in the research of asthma in the elderly. The~     investigators have analyzed national asthma data sets to look for disparities in older~     adults, have conducted qualitative research to determine factors associated with poor~     control in the elderly, and have performed a pilot study of a self-regulation intervention~     which was able to improve outcomes. The investigators also have over 20 years of experience~     in asthma self-regulation interventions and physician communication enhancement for multiple~     populations of asthma patients. The investigators will combine these strengths into their~     current protocol.~      The intervention program will be based on the self-regulation theory of behavior, which will~     enhance the participants' ability to self-manage this chronic condition, actively involve~     the participant in their own health care management, and produce sustained results. In this~     proposal, the investigators will evaluate a self-regulation asthma intervention in a diverse~     population of older adults. The intervention will be personalized to the challenges and~     goals each individual faces, which will enhance its applicability in different populations.~     This intervention will incorporate standard asthma education, complementary techniques for~     which older adults have expressed a strong interest, and enhanced communication with each~     participant's physician. Asthma specific outcomes will be assessed at 1, 6, and 12 months.~     The primary goal of this intervention is to decrease health care utilization (emergency~     department, urgent care, hospital, and unscheduled visits) for older adults with asthma. The~     investigators will also assess the ability to improve quality of life, asthma symptoms,~     asthma control, lung function parameters, self-efficacy, and cost effectiveness.~   "
82385|NCT01979042|"~     Renal colic is usually caused from an obstructing stone along the ureter. Some of the~     patients present with a high level of creatinin in the blood, even though there is a normal~     functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal~     function during acute changes.~      Several works have shown that modern urinary markers such as NGAL (neutrophil~     gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier~     and are much more sensitive for kidney insult. There is a lack of research on their role in~     acute kidney obstruction~   "
82386|NCT01979029|"~     To evaluate the influence to the blood supply of the anastomosis and the harvest of the No.~     253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and~     resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or~     dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of~     rectal carcinoma.~   "
82387|NCT01979016|"~     The primary objective of the study is to assess the efficacy of dupilumab, compared to~     placebo, in adult patients with moderate-to-severe atopic dermatitis.~   "
82388|NCT01979003|"~     To determine if Fluorescein systemic injection during hysterectomy procedure can be useful~     in revealing the depth of endometrial cancer invasion.~   "
82389|NCT01978990|"~     Modern medicine provides many solutions that are intended to help control the patient's~     blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone~     to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose~     level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of~     this trial is proving the concept and the feasibility of using a medical informatics system~     comprised of computer hardware, software and a smartphone application to achieve better~     outcomes.~   "
82390|NCT01978977|"~     Investigators propose to assess,the safety and tolerability profile (number of participants~     with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as~     first line treatment of patients with metastatic Breast Cancer.~   "
82391|NCT01978964|"~     This is an open label phase 1b maintenance therapy study to evaluate the long-term safety,~     immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients~     who have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.~   "
82392|NCT01978951|"~     If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render~     proper CKD care, it is interesting if their intimate relationship and commitment to their~     responsible village households will result in better outcomes when compared with the~     conventional care model as mention above. In this project, we plan to compare the~     effectiveness of a conventional care program against an integrated multidisciplinary CKD~     care program provided by nephrologists in conjunction with well-trained paramedical~     personnel and VHVs on CKD progression.~   "
82393|NCT01978938|"~     This is a Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to~     Assess the Efficacy and Safety of Eravacycline Compared with Levofloxacin in Complicated~     Urinary Tract Infections (cUTI)~   "
82394|NCT01978925|"~     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared~     to usual care, in patient discharge in an emergency department in patients with hypertension~     and/or diabetes mellitus type 2.~   "
82395|NCT01978912|"~     The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in~     subjects with lumbar disc herniation.~   "
82396|NCT01978899|"~     Studies have shown that patients who weigh more at the time of cancer diagnosis may be at~     increased risk of complications from surgery, fatigue, poor body image and other problems.~     Some research suggests that losing weight after cancer diagnosis can lead to improvements in~     these problems, as well as having other potential benefits for cancer survivors. Programs~     that reduce calories and increase exercise have been shown to help cancer survivors lose~     weight, but more research is needed to develop and test weight loss programs in cancer~     survivors.~      This study is designed to look at the ability of a 15-week diet and exercise program to help~     cancer survivors lose weight. The investigator will look at changes in weight, body~     composition, quality of life, fatigue, body image as well as diet and exercise patterns, to~     see if this program can help men and women feel better and live healthier lives after cancer~     diagnosis.~   "
82397|NCT01978886|"~     The purpose of the study is to investigate how high the prevalence of diabetes (known and~     unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40~     %.~      Another purpose is to investigate whether patients with diabetes have a worse and more~     painful frozen shoulder than patients without diabetes, and whether the diabetes have an~     influence on the prognosis.~   "
82418|NCT01978613|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple~     doses of NNC0113-0987 in an oral formulation in healthy subjects.~   "
82419|NCT01978600|"~     The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period~     using Simbrinza™ topical ophthalmic suspension.~   "
82398|NCT01978873|"~     This clinical trial is designed on the basis of an unmet clinical need, as well as other~     factors including: 1) the ability to identify subjects at high risk of dying early from~     their disease, 2) the fact that hormonal therapy has already been shown to improve survival~     when applied early in the natural history, 3) the availability of chemotherapy such as~     cabazitaxel that can improve survival in subjects with advanced disease and 4) that~     chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time~     to progression.~      It is the investigators hypothesis that a more appropriate group of patients who may benefit~     from the curative potential of systemic chemo-hormonal modality is that with minimal, but~     detectable disease who have a high probability of developing metastatic disease, clinical~     symptoms and eventually death from prostate cancer in a defined time frame. The~     investigators hypothesize further that the approach is likely to be more effective at a time~     of minimal tumour burden, resulting in minimization of the overall burden of therapy and~     better quality of life while on treatment.~      This trial will determine whether any benefit is gained by adding chemotherapy before~     hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or~     high risk disease.~   "
82399|NCT01978860|"~     This is a prospective, non-randomized, first-in-man investigational study, to assess the~     safety and technical feasibility, deployment and withdrawal characteristics of the~     NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and~     evaluating the CTO penetration rate.~      Each study subject/patient will have a total of one (1) procedure performed for this study.~   "
82400|NCT01978847|"~     Retrospective review will allow for an evaluation of potential patient- or procedure-related~     factors that are associated with the development of either radiologic or clinical~     adjacent-segment pathology.~   "
82401|NCT01978834|"~     This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone~     Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly~     woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total).~     Significant and good correlation was observed between Density Index (DI) determined with~     Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition,~     with determination of 90% sensitivity and specificity thresholds, significant number~     (65-75%) of patients could be diagnosed without additional verification with DXA.~      First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy~     patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age~     60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for~     diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed.~     The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and~     non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict~     the outcome of currently available fracture risk assessment tools.~        1. To investigate optimal configuration of ultrasound parameters and patient~          characteristics for prediction of proximal femur and lumbar spine BMD for women in each~          four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status~          with a reference female population (American-Caucasian) in each four decades of age; 50~          to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~   "
82402|NCT01978821|"~     the purpose of this study was to study the effect of stem cell therapy on common symptoms of~     cerebral palsy patients.~   "
82403|NCT01978808|"~     For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle~     aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize~     that a FNA needle with a side port could improve the diagnostic yield. The aim of this~     prospective randomized study is to determine whether there is a difference in diagnostic~     yield in patients with pancreatic masses for evaluation.~   "
82404|NCT01978795|"~     This study evaluated Brain 101: The Concussion Play book, an intervention that provides~     education and resources on concussion management for high schools. The study hypotheses were~     that athletes and parents who viewed the Brain 101 program would demonstrate increased~     knowledge and self efficacy in concussion management, and that use of the intervention would~     positively affect school concussion management practices.~   "
82405|NCT01978782|"~     Depression is the most common mental health disorder among HIV-patients. Recognizing and~     treating depression is important in order to improve quality of life and health outcomes in~     those living with HIV. In clinical practice selective serotonin reuptake inhibitors (SSRIs)~     are used most frequently in HIV patients with depressive symptoms. A complicating factor in~     the concomitant use of antiretroviral agents and antidepressant therapy is the occurrence of~     drug-drug interactions. Citalopram can be seen as one of the preferred SSRIs in HIV-infected~     patients because citalopram has a relatively favourable drug interaction profile compared to~     other SSRIs. Raltegravir is an HIV-1 integrase inhibitor and is frequently being used as~     antiretroviral agent in combination with tenofovir/emtricitabine in HIV-patients.~     Raltegravir has shown sustained antiretroviral activity, is generally well tolerated and has~     little propensity to interact with other drugs because it does not inhibit or induce CYP450~     enzymes. Theoretically, no clinically relevant drug interaction is expected between~     raltegravir and citalopram as raltegravir is not a CYP2D6 substrate and thus will not be~     affected by the possible inhibition of CYP2D6 by citalopram. Raltegravir is metabolized by~     UGT but citalopram is not known to influence UGT. A possible interaction may occur through~     inhibition of P-gp mediated transport of raltegravir by citalopram. However, even when no~     drug interaction is expected theoretically, it may be recommended to collect sufficient~     clinical evidence to support this hypothesis because unexpected interactions with~     raltegravir have been observed in the past. In order to be able to recommend raltegravir and~     citalopram concomitant use, a pharmacokinetic study in healthy volunteers is proposed.~   "
82420|NCT01978587|"~     The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics~     (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage~     renal disease (ESRD) receiving hemodialysis~   "
82590|NCT01976351|"~     Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and~     predict its invasiveness. There is potentially molecular change over the Barrett's esophagus~     in this Chinese population.~      To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus~     and evaluation of invasiveness~   "
82407|NCT01978756|"~     In order to evaluate the late outcome in patients curatively treated for breast cancer, a~     special outpatient clinic will be developed.~      There are two main purposes of the outpatient clinic. The first purpose is evaluating the~     results of the radiation treatment by mapping A) late toxicity and B) tumour control and~     survival.~      The second purpose is that this outpatient clinic for late outcome will also function as a~     pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which~     multiple late outcome variables will be recorded. In this pilot we want to investigate~     whether physical presence of the patient on the outpatient clinic, allowing physical~     examination, has any added value to the questionnaires filled in by the patient at home.~      The ultimate aim of this new CAT project is to use these multicentric data to develop models~     for predicting both oncological outcome and late side effects. Insight in the beneficial and~     adverse effects of a certain treatment using these predictive models, will be required~     choose the optimal treatment for the individual patient using a shared decision making~     process.~   "
82408|NCT01978743|"~     In this study investigators will use a multi-modal imaging approach of MRS and fMRI to~     comprehensively assess the biological changes in the brain associated with EFV-based regimen~     (EFV/FTC/TDF), specifically alterations in the brain circuitry, function and local~     neurochemistry, and their correlation with neuropsychological function. In a cohort of~     HIV-infected patients who are clinically stable on the commonly use regimen of~     EFV/emtricitabine (FTC)/truvada (TDF) or Atripla, investigators propose to replace the EFV~     component with an integrase inhibitor, Raltegravir (RAL), given as the RAL and FTC/TDF to~     evaluate the EFV-related neural alterations. This is a multidisciplinary study which will be~     lead by Dr. Nina Lin, in collaboration with the research teams of Dr. Alexander Lin,~     Director of the Center for Clinical Spectroscopy, and Dr. Emily Stern, Director of the~     Functional Neuroimaging Laboratory, both members of the Brigham and Women's Department of~     Radiology at Harvard Medical School, as well as Dr. Jane Epstein, a researcher in Dr.~     Stern's research group. Dr. Epstein is a staff psychiatrist at Brigham and Women's hospital~     with extensive experience and expertise in research on abnormalities of affective and~     motivational processing in the context of neuropsychiatric disorders. Investigators will~     utilize the established clinical research platform in the Infectious Disease outpatient~     clinical practice at the Brigham and Women's Hospital, where there is currently have many~     ongoing HIV-related studies and a large panel of HIV-infected patients motivated to be~     involved in clinically relevant research. Investigators propose to use advanced neuroimaging~     to measure biologically changes in the brain associated with long-term EFV use with the~     following specific aims:~        1. Determine changes in neurometabolites measured by MRS in the brain associated with~          long-term EFV use~        2. Assess for alterations in neural activity correlated with affective symptoms associated~          with EFV vs RAL use using fMRI, and their associations with changes in neurometabolites~          assessed by MRS, and with changes in cognition assessed by Trail Making and Digit~          Substitution Tests.~        3. Determine changes in emotion, cognition and sleep quality after switching from EFV to~          RAL, and how they correlate with subject treatment preference.~      This clinical study will extend our current understanding of EFV neurotoxicity by further~     defining the nature of these biological changes. Further elucidation of the neurobiological~     underpinnings of EFV-induced CNS toxicity will have clinical relevance in improving the~     quality of life and drug adherence of HIV-infected patients on ART, especially among older~     patients or those with baseline neuropsychiatric disorders, whom at baseline are more~     vulnerable to neurocognitive decline from long-term HIV infection.~   "
82409|NCT01978730|"~     As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial~     effects on learning and memory ability in animal models of vascular dementia (VaD). The~     study hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients~     with VaD and will be well tolerated. The purpose of the study is to determine the efficacy~     and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures~     include general cognitive function, executive function, daily living skills, and mental~     behavior changes of symptoms in VaD patients.~   "
82410|NCT01978717|"~     The purpose of this study is to prove whether general anesthesia combined with epidural~     anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general~     anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve~     the prognosis.~   "
82411|NCT01978704|"~     The aim of this study is to compare the feasibility and the efficacy on short-term glucose~     control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of~     the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with~     insulin pump~   "
82412|NCT01978691|"~     Obesity is a major problem worldwide, and it is related to abnormalities in glucose and~     lipid metabolism. The purpose of this study is to investigate the effect of a dietary~     supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic~     (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled~     intervention trial. The supplement is ingested once per day for the duration of six months,~     and participants will attend a follow-up visit one month after the end of the intervention.~     The study will enroll 232 participants (58 per study arm) in four research centers in~     southern Finland.~   "
82413|NCT01978678|"~     The application of biomarkers that are more closely associated with eosinophillic airway~     inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial~     reactivity could improve asthma control by better directing treatment. A systematic review~     and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention~     on clinical symptoms compared with exhaled nitric oxide or induced sputum count.~   "
82414|NCT01978665|"~     The objective of this study is to investigate if there is an effect on exercise performance~     og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic~     obstructive pulmonary disease(COPD)~   "
82415|NCT01978652|"~     The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017~     (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese~     and Caucasian adult healthy participants. The secondary Objective is to assess the safety~     and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and~     Caucasian adult healthy participants.~   "
82416|NCT01978639|"~     This study will assess the outcomes of three currently available regenerative treatments~     (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful~     degenerative conditions of the joints. Patients receiving one these treatments will be~     assessed before the treatment procedure and followed up at four points over the six months~     after their procedure. Patients' pain, quality of life, and pain medication use at follow up~     will be compared to baseline levels. The investigators hypothesize that all three treatments~     will be effective in reducing pain, improving quality of life, and reducing pain medication~     usage.~   "
82417|NCT01978626|"~     Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective~     intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app~     programs of smart phone would enhance the compliance and performance of behavioral~     intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic~     sleep diary along with message reminder system, social persuasion system and Tai-Chi~     practice system will be tested subsequently for their efficacy.~   "
82432|NCT01978431|"~     Examine the interaction between stimulants, such as cocaine and methylphenidate, and~     impulsivity.~   "
82421|NCT01978574|"~     Cognitive problems are a primary concern for people with multiple sclerosis. In many cases,~     people with MS report these issues to be more debilitating than the motor symptoms that are~     targeted by most treatment strategies. For people with MS, impaired memory and thinking~     skills can interfere with the ability to function efficiently in multiple professional and~     personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking~     skills is a vitally important research priority. We now know that engaging in intellectually~     enriching activities helps protect against the negative impact of MS disease-related~     declines in memory and thinking. Such activities contribute to something called 'cognitive~     reserve,' which serves as a protection against disease-related declines in memory and~     thinking. Thus far, no one has created a treatment that aims to provide a concentrated~     'dose' of intellectual enrichment to build cognitive reserve. The present intervention aims~     to do precisely this. Here, we have developed a program of enriching activities that are~     delivered via a personal iPad. This allows for a 12-week 'treatment' that is entirely~     home-based, while also providing close personal contact between participants and our study~     personnel, who will communicate daily via emails. Week by week, participants choose from a~     menu of intellectually enriching activities such that their treatment is dynamic and~     customizable to fit their interests. The intervention is designed to be fun, as we hope the~     activities will be incorporated into people's lives beyond the period of the study itself.~     Given what we already know about the striking benefits of cognitive reserve to protect~     against disease-related declines in cognitive functioning, we expect to show that treatment~     with a daily, intense, intellectually enriching schedule of activities results in improved~     thinking and memory for people with MS. We will also investigate the positive impact of our~     treatment on the brains of people with MS through brain scans. We expect to see evidence for~     a shift toward more efficient processing in the brain, changes that translate to improved~     memory and thinking skills.~   "
82422|NCT01978561|"~     The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in~     subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.~   "
82423|NCT01978548|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).~   "
82424|NCT01978535|"~     This study is designed to investigate whether the treatment of non-anemic iron deficiency~     with intervenous iron sucrose will result in decreased symptom reporting and improved~     cardiovascular indices in adolescents (age 12-21) with Postural Orthostatic Tachycardia~     Syndrome (POTS).~   "
82425|NCT01978522|"~     Recruiting, retaining and gathering complete data on participants in research projects, be~     they patients or health professionals, can be extremely difficult. These problems increase~     the risk that research will be abandoned before its true value is appreciated, or lead to~     delays in resolving uncertainty for decision makers, while further studies are done. Poor~     recruitment, retention and outcome collection frequently lead to many prospective studies~     being extended, increasing costs. Researchers need to use strategies that are themselves~     evidence-based. This study proposes to link with an existing longitudinal ageing study~     called NICOLA to provide evidence on what research participants prefer in relation to~     providing personal information through a self-completed questionnaire. NICOLA is a large~     study of people over the age of 50 that is being conducted in Northern Ireland. NICOLA is~     aiming to recruit 8500 people and will ask them questions about participation in social~     activities, including organised structured and informal activities; relationship quality;~     loneliness; stress; resilience; quality of life; alcohol intake; food poverty and assess~     their health and wellbeing. Participants in NICOLA agree to having an interviewer visit them~     at home to ask questions about their lives, complete questionnaires in their own time and~     attend a health assessment appointment. They also agree to being followed up over a course~     of at least 10 years. The research described here will examine the impact of differing times~     and formats of a self assessment questionnaire on completion rates, specifically:~        -  To assess the effect of being given a questionnaire during a face to face interview~          with a researcher compared to receiving it by post~        -  To explore the potential impact of interview fatigue on completion rates~   "
82426|NCT01978509|"~     The purpose of this study is to compare the efficacy of a low-volume bowel preparation~     versus a high-volume bowel preparation for bowel cleansing on hospitalized patients~     undergoing colonoscopies.~   "
82427|NCT01978496|"~     To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in~     relieving symptoms of acute migraine and to further explore the dose response relationship~     of eletriptan.~   "
82428|NCT01978483|"~     Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and~     health. One of the harmful effects of long-term UV light exposure is that it can cause skin~     cancer. The mechanism by which UV light causes skin cancer is not entirely understood. One~     of the ways UV light causes cancer is by modifying DNA molecules in the cells of the skin.~     Another mechanism involved in cancer formation by UV light is immunosuppression. By this~     mechanism, UV light inactivates cells of the immune system of the skin. The immune cells are~     responsible for the detection and destruction of foreign substances and organisms such as~     bacterias and viruses but they also recognize and destroy cancer cells. UV light is known to~     prevent cells of the immune system to destroy cancer cells.~      In laboratory experiments, a medication called denosumab has been shown to diminish the~     inhibition of ultraviolet-induced suppression of skin immunity. In other words, this~     medication could block the effect of UV on cells of the immune system and might allow~     patients taking this drug to be better protected from skin cancer.~      The objective of this study is to test whether denosumab blocks the immunosuppressive effect~     of UVB light in healthy subjects. This study is divided into two stages. In the first stage,~     ten subjects (Cohort 1) will be sensitized to diphenylcyclopropenone (DPCP), a topical~     sensitizer commonly used for the treatment of alopecia areata and cutaneous warts. By~     reexposing the subjects to DPCP in incremental doses, dose-response levels of cutaneous~     hypersensitivity reactions in normal skin will be obtained. This will allow comparison of~     the normal levels of DPCP-induced cutaneous hypersensitivity (CHS) reaction in non~     UV-exposed skin (Cohort 1) to the CHS obtained from the two UVB-exposed experimental groups~     of Cohort 2.~      In the second stage of the study, 20 subjects (Cohort 2) will be exposed to an~     immunosuppressive dose of ultraviolet B (UVB) 24 hours prior to DPCP sensitization. This is~     expected to result in the abolition of CHS upon rechallenge with DPCP. In order to assess~     whether denosumab can reverse UVB-induced immunosuppression, the subjects will have~     previously been randomized to receive a single 1mL injection of either 60 mg denosumab~     (group A; 10 subjects) or 1 mL saline (group B; 10 subjects) two weeks before UVB exposure.~     CHS reactions elicited by DPCP rechallenge will be compared between the denosumab and saline~     groups.~   "
82429|NCT01978470|"~     The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS~     system.~   "
82430|NCT01978457|"~     We will develop a procedure for conditioning cue-cocaine associations in human drug users.~     Next, we will reactivate that learning and intervene pharmacologically to prevent the~     reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and~     pharmacological approach will have significant potential for persistently inhibiting~     relapse.~   "
82431|NCT01978444|"~     Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied~     in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has~     been proven unavoidable.~      Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in~     the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2~     lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and~     should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.~      Thus, the comparison of short-term and long-term outcome between laparoscopic D2~     lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2~     lymphadenectomy for locally advanced gastric cancer based on a well designed randomized~     controlled trial is needed.~   "
82433|NCT01978418|"~     The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is~     cleared at birth. This process is mediated through the activation of airway epithelial~     sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary~     adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its~     activity, measured as nasal potential difference, correlates with lung compliance.~     Therefore, in the human newborn infant ENaC may be important for physiologic postnatal~     adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We~     hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes~     delayed clearance of lung fluid and thereby contributes to the risk for development of~     transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).~   "
82434|NCT01978405|"~     Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes~     after contrast media injection. Although the risk of developing CIAKI is low in patients~     with normal renal function, it is dramatically higher in patients with conditions such as~     diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that~     contrast agents can induce endothelial dysfunction partially via free radicals in diabetes.~     Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD~     are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent~     antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute~     kidney injury and endothelial dysfunction in type 2 diabetes.~   "
82435|NCT01978392|"~     The specific aim of the study is to evaluate the health benefits of a series of group~     workshops designed for workers with chronic physical health conditions. The facilitated~     workshops apply principles of pain and illness self-management to help workers deal with~     health-related challenges while at work. The workshops address issues of pain management,~     physical job demands, pacing of work, communication, problem solving, and coping. Half of~     the participants in the study will be randomly assigned to attend workshop sessions (10~     hours total), and all study participants will be followed for one year. The primary~     hypothesis is that workers who participate in these workshops will show improvements in work~     engagement and reductions in work limitation in the subsequent 12 months.~   "
82436|NCT01978379|"~     We are conducting a study to evaluate two investigational devices that may help us better~     monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery.~     We want to collect information on how people respond to pain related to their surgery.~     Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In~     this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris~     monitors to look at measurements of pain. We will compare the measurements from the study~     devices to the measurements of heart rate and blood pressure. We hope to enroll about 40~     subjects in this study at the University of Washington Medical Center.~   "
82437|NCT01978366|"~     This study is designed to provide 6-months continuous dosing with the study medication,~     called HT-100, on participants who successfully completed the predecessor study~     (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability,~     pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics~     (measuring how much drug is in the bloodstream) in participants with a broad spectrum of~     Duchenne muscular dystrophy (DMD).~   "
82438|NCT01978353|"~     Preview research reports evidence of cognitive plasticity among individuals with amnestic~     Mild cognitive Impairment, and small-size studies have suggest that this population can~     benefit from memory training. This project intends to assess the efficacy of cognitive~     training in persons with MCI with a randomized controlled design.~      The hypothesis is that cognitive training can improve memory performance for persons with~     amnestic mild cognitive impairment and this improvement can be maintained over time.~   "
82439|NCT01978340|"~     The study objective is to collect heart rate, respiration rate and motion data of patients~     admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the~     monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data~     regarding sleep condition, scoring and quality of sleep and in and out of bed status,~     patient turns will also be collected and compared to data collected by EarlySense~     contactless monitor. Different patient population will be monitored including obese,~     morbidly obese, patients with or without obstructive/central apnea, patients with or without~     arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will~     be monitored~   "
82440|NCT01978327|"~     GSK2647544 is an orally available, selective inhibitor of Lp PLA2 that is being developed~     for the treatment of Alzheimer's disease. The current study is a single-blind, randomised,~     placebo-controlled, 4-cohort study to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of repeat doses of GSK2647544. Cohorts 1, 2 and 3 will evaluate escalating~     doses of GSK2647544 in young healthy volunteers for 7 days, 7 days, and 14 days,~     respectively. Cohort 4 will evaluate repeat doses of GSK2647544 in healthy elderly~     volunteers for 14 days. Additionally, Cohorts 1 and 3 will include an assessment of~     potential drug-drug interaction with simvastatin to examine CYP3A4 inhibition by GSK2647544.~   "
82441|NCT01978314|"~     This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult~     volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with~     acute kidney injury (AKI).~   "
82452|NCT01978171|"~     The investigators will determine which factors are predictive for the development and~     severity of everolimus-induced interstitial lung disease and will develop a prediction model~     based on these risk factors.~   "
82453|NCT01978158|"~     Oxygen is a widely available gas that is cheap, easy to get and extensively used in~     medicine. From animal studies it has become apparent that increasing or lowering the degree~     of oxygen in the blood, the inflammatory response can be altered. We will investigate of~     this is also true in humans by increasing, lowering or keeping oxygen levels normal while~     giving healthy subjects a short inflammatory stimulus.~   "
82591|NCT01976338|"~     To provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in~     patients with visual impairment due to macular edema secondary to BRVO~   "
82629|NCT01975844|"~     Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron)~     protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain~     in target~      Objectives:~        1. Decreased variability of Hgb~        2. Increase the % of patients in target range c Increase in time that Hgb remains target~          range~   "
82442|NCT01978301|"~     This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid~     patients who are scheduled for surgical excision of one or more keloid scars (up to nine)~     will be recruited to the study. The aim is to investigate how collagen synthesis within~     keloid scars is affected by the current approved steroid treatment for keloids,~     triamcinolone acetonide (TAC). The primary endpoint will be fractional collagen synthesis in~     keloids which have received intra-lesional injections of TAC, placebo or no treatment prior~     to their removal. Fractional collagen synthesis will be determined using an established~     isotope/mass spectrometric technique which measures levels of deuterium incorporation into~     collagen following administration of heavy water to the subject. In addition; keloid tissue~     samples will be evaluated post surgery to identify further biomarkers of extracellular~     matrix synthesis and degradation for application in future clinical studies. Subjects will~     complete a screening visit and will then be randomised to receive three intra-lesional~     injections of TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be~     randomised to different treatment sequences depending on the number of keloids they have~     scheduled for surgery, in such a way that subjects with multiple keloids will receive~     different arms of study treatment in their different keloids. Planned surgery for removal of~     their keloid(s) will be performed at week 6-8. All subjects will receive daily heavy water~     (Deuterium oxide) administration (twice daily or thrice daily as directed), with the first~     dose being taken at the Week 2 clinic visit and the final dose being taken on the day prior~     to surgery. A follow-up visit will be conducted at 1-4 weeks post-surgery.~   "
82443|NCT01978288|"~     This study tests the hypothesis that an increase in pathogenic bacteria within the infant~     airway leads to increased airway inflammation, decreased airway function and ultimately~     airway obstruction throughout the first two years of life.~   "
82444|NCT01978275|"~     Stimulating catheters have been introduced to reduce the incidence of secondary failure~     after continuous peripheral nerve blocks, but they effectiveness over traditional~     nonstimulating catheters is still controversial. Furthermore no volume-response study has~     compared the success rates of the two techniques for continuous lumbar plexus block. The aim~     of this prospective, randomized, blinded study is to detect if stimulating catheters~     decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful~     lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating~     catheters.~   "
82445|NCT01978262|"~     The purpose of this pilot research project is to look at the effect of the inactivated~     influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response~     known as cytokines or signal molecules. The investigators also want to see if the timing of~     vaccine administration has any effect on women's reproductive hormones. The investigators~     hypothesis is that influenza vaccine given right before ovulation may change the hormone~     levels usually seen after ovulation. Thi~   "
82446|NCT01978249|"~     Short description for lay public, include brief statement of the study hypothesis~   "
82447|NCT01978236|"~     This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30~     evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic~     melanoma to the brain. All subjects in this study are required to have accessible~     extracranial metastases and are agreeable to undergo repetitive biopsies. The first cohort~     of 15 subjects will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior~     to surgery (Cohort A); the second cohort of 15 subjects will receive the combination of~     dabrafenib 150 mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery~     (Cohort B). The primary purpose of this study is to determine levels and distribution of~     dabrafenib, its metabolites, and trametinib (Cohort B only) in parenchymal brain metastases,~     extracranial metastases, and peripheral blood (plasma) within two cohorts of subjects with~     BRAF V600E/K mutation-positive melanoma that has metastasized to the brain. All subjects~     will be followed for survival and new anti-cancer therapy for a total of two years or until~     death or the subject wishes to withdraw from further follow-up.~   "
82448|NCT01978223|"~     This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe~     gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in~     Venezuela and to assess the current disease burden after introduction of the vaccine.~   "
82449|NCT01978210|"~     This pilot study is designed to investigate the feasibility of comparing a standard~     behavioral intervention and an innovative intervention that incorporates the use of a~     wireless moisture alarm in training children with autism how to independently use the toilet~     for urination. We hypothesize that the study protocol will be feasible, as measured through~     review of achieved recruitment targets, successful randomization, and >80% retention of~     subjects with com- plete data collection. Our second hypothesis is that therapists will~     deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and~     parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A~     secondary aim of this study is to examine trends in outcome data by conducting a small RCT~     (N = 30) of wireless moisture alarm and standard behavioral toilet training, with the~     hypothesis that the moisture alarm intervention will result in fewer toileting accidents, a~     higher rate of toileting success and greater parental satisfaction.~   "
82450|NCT01978197|"~     The primary aim of this study is to determine menthol smokers' perception, product~     preference, and pattern of use across six products including, 1) mint-flavored 2mg nicotine~     gum ; 2) mint-flavored 4mg nicotine gum; 3) non-flavored 2mg nicotine gum; 4) non-flavored~     4mg nicotine gum; 5) mint-flavored electronic cigarette; and 6) non-flavored electronic~     cigarette. Fifty smokers (all African American menthol smokers) will be recruited for this~     study. Participants will undergo a baseline assessment followed by a 2-week product sampling~     phase.~   "
82451|NCT01978184|"~     This is a randomized phase II trial that will examine the ability of the hydroxychloroquine~     to improve the clinical activity of a pre-operative regimen of gemcitabine and~     nab-paclitaxel in subjects with potentially resectable adenocarcinoma of the pancreas.~     Eligible subjects will receive 2 cycles of gemcitabine and nab-paclitaxel (day 1, 8, 15)~     with or without hydrocychloroquine followed by surgical resection. Primary endpoint will be~     histologic response as graded by Evans criteria. Secondary endpoints will be CA19-9 response~     and PET response. Pre and post treatment tissue biopsies will be obtained to assess for~     levels of autophagy in tumor, liver and peripheral blood.~   "
82630|NCT01975831|"~     This is a multicenter, open-label, study with a standard 3+3 dose-escalation phase, followed~     by an expansion phase in subjects with solid tumors~   "
82454|NCT01978145|"~     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks~     noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg~     capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The~     primary objective of this study is to establish the non-inferiority of the efficacy of the~     FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler~     administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks),~     Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and~     Follow-up (1 week). The total duration of the study for each subject will be at least 32~     weeks.~   "
82455|NCT01978132|"~     Patients with primary hyperaldosteronism experience more cardiovascular events compared to~     patients with primary hypertension, independent of the blood pressure level.~      In this research we hypothesize that patients with primary hyperaldosteronism are more~     susceptible to ischemia-reperfusion injury.~   "
82456|NCT01978119|"~     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week~     non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg~     capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults~     and adolescents with asthma. The primary objective of this study is to demonstrate that FSC~     250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50~     mcg administered BID by multi-dose inhaler . The study consists of six phases:~     Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3~     weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the~     study for each subject will be at least 31 weeks.~   "
82457|NCT01978106|"~     Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the~     AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of~     patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal~     astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of~     corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric~     value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI),~     iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured~     values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric~     calculators.~   "
82458|NCT01978093|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13~     and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in~     infants and toddlers.~   "
82459|NCT01978080|"~     The specific aim of this study is to evaluate if tremor severity and quality of life can be~     improved more using continuous home monitoring along with traditional assessments versus~     traditional assessments alone.~   "
82460|NCT01978067|"~     The aim of this study is to further demonstrate the safety , validity and quality of~     (sexual)life of vaginal operation for previous cesarean scar defect resection.~   "
82461|NCT01978054|"~     The purpose of this study is to identify and evaluate dissemination strategies to promote~     the uptake of evidence-based cancer and other chronic disease prevention among state-level~     public health practitioners. Dissemination strategies such as multi-day in-person training~     workshops and electronic information exchange modalities are hypothesized to associate with~     improved access and use of public health evidence and organizational supports for program~     and policy decision making based on evidence-based public health.~   "
82462|NCT01978041|"~     The importance of fluoridated water to control caries is well recognized. Although the mode~     of action of fluoridated water is known (related to a slight increase in fluoride~     concentration in saliva/dental biofilm in individuals living in fluoridated areas), the~     kinetics of fluoride concentration in saliva after ingestion of food prepared with~     fluoridated water, either from fluoride remaining in the oral cavity after mastication, or~     from fluoride returning from salivary secretion is not known in details. Therefore, the aim~     of this study is to assess fluoride bioavailability after ingestion of food prepared with~     fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult~     volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical~     Brazilian meal cooked with non-fluoridated water (<0.1 ppm F); b. a typical Brazilian meal~     cooked with fluoridated water (1 ppm F); c. non fluoridated water (<0.1 ppm F) and d.~     fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes~     after the ingestion, a blood sample will be collected by digital puncture, and a sample of~     unstimulated saliva will be collected. Fluoride concentration in the samples will be~     determined by an ion specific electrode adapted for microanalysis. Results will be analyzed~     by ANOVA, with significance limit of 5%.~   "
82463|NCT01978028|"~     The primary efficacy objective of this study is to evaluate the effect of ferric~     carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.~   "
82464|NCT01978015|"~     Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second~     leading cause of world blindness. The treatment of glaucoma is mainly based in reducing~     intraocular pressure (IOP) with topical medications. Many patients required two or more~     medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs~     (PGA) are frequently used in clinical practice because their additive effect in lowering IOP~     levels. The aim of this study was to investigate the effects of fixed combinations of~     timolol maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal~     thickness in pseudophakic patients with primary open-angle glaucoma (POAG).~   "
82507|NCT01977456|"~     The primary goal of this trial is to determine if individuals with acute ischemic stroke~     treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV~     eptifibatide started within 3 hours of symptom onset are more likely to have a better~     outcome than individuals treated with standard IV rt-PA alone.~   "
82508|NCT01977443|"~     A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept~     study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase~     adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of~     APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical~     resolution of EKC (objective and subjective assessments), presence of opacities, visual~     acuity and frequency of second eye infections, and to assess the safety and tolerability of~     APD-209 Eye drops in EKC infected eyes.~   "
82465|NCT01978002|"~     Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome~     symptoms seen frequently in the general population. Clinical diagnostic terms used to~     describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS),~     chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between~     these entities, and the distinction between them is based more on eminence than evidence.~      Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of~     both bladder pain and urinary urgency/frequency. However, no previous studies have~     investigated whether entities such as IC/BPS and OAB might merely represent different points~     in a continuum of bladder sensory sensitivity. Moreover, we know of no studies that have~     directly compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory~     sensitivity.~      In the study, a team of investigators with complementary expertise will perform a~     population-based study assessing bladder and overall sensory sensitivity, in a cohort of~     women representative of the population with respect to the entire continuum of bladder pain~     (from none to severe), and symptoms of urgency/frequency. These individuals will undergo~     urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and~     auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity~     in the bladder is related to sensory sensitivity elsewhere in the body, suggesting a~     CNS-driven mechanism, and 2) individuals in the population with greater global sensory~     sensitivity will display: a) more bladder pain, b) more urgency/frequency, and c) other~     symptoms of centrally-mediated pain states, such as pain in regions other than the bladder,~     fatigue, and insomnia.~   "
82466|NCT01977989|"~     The purpose of this study is to study how well using a powdered form of the antibiotic,~     vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented~     spinal surgery for traumatic injury to the back.~      Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating~     certain kinds of bacteria. It is also used to prevent infections of the surgery site.~      This will be a study in which the experimental treatment is compared to a standard (control)~     treatment. It will be prospective in nature, meaning that it will follow patients forward in~     time, and it will consist of a randomization process to determine who will receive the~     experimental treatment versus the standard (control) treatment.~      The study will take place at Regional Medical Center (The MED). 140 subjects will be~     participating in this study.~      The investigators hypothesize that the topical use of powder vancomycin will decrease the~     rate of surgical site infection.~   "
82467|NCT01977976|"~     Implantation failure remains one of the major factors limiting success in IVF treatment. It~     was postulated that the local injury to endometrium induces secretions of cytokines and~     growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding~     EGF-like growth factor which enhance decidualisation and facilitate implantation. It may~     also up-regulate the gene expressions related to endometrial receptivity and optimize the~     endometrial development. In stimulated cycles, local injury to the proliferative endometrium~     has been postulated to delay endometrial development thereby inducing synchronicity between~     endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al,~     2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury~     by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the~     on-going pregnancy rate in subfertile women undergoing IVF treatment.~   "
82468|NCT01977963|"~     Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side~     effects are found in 1% - 5% of the patients1. One of the most serious side effect is~     agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe~     infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon~     may be involved because the antigranulocyte antibodies or lymphocyte sensitized to~     antithyroid drugs are found in these patients6,7. The recognition of major~     histocompatibility complex class II peptide complexes by T lymphocytes is central to the~     development of immune response. According to a report in 1996, the HLA DRB1*08032 allele is~     strongly associated with susceptibility to methimazole-induced agranulocytosis20.~      Recently, there are new techniques for genetics study. We aimed to identify the associated~     genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look~     at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and~     -DP. If no significant change is found in the above genes, we will consider whole exon~     sequencing with next-generation sequencing, Statistic analysis will include appropriate~     linkage analysis, association study, variation data analysis, pathway analysis. If we can~     identify the genetic change and perform genetic examinations before prescription, we can~     avoid the happening of severe side effects.~   "
82469|NCT01977950|"~     The purpose of this study is to estimate the prevalence of nutritional risk and examine~     nutritional care practices in the hospitalized elderly at one large university hospital in~     Norway.~   "
82470|NCT01977937|"~     The purpose of this study is to evaluate the patient experience when using gabapentin with~     other pain control medications after posterior spinal fusion surgery for scoliosis in~     adolescents. These results will be compared to patients who underwent the same procedure~     during the study period and received the same standardized pain control regimen excluding~     gabapentin. Effects on pain level, opioid use, satisfaction and narcotic use after discharge~     from the hospital will be measured. Opioid side effects including nausea, sedation and~     urinary retention (inability to empty one's bladder) will also be recorded.The null~     hypotheses are as follows:~        1. There is no significant difference in pain control when adding gabapentin to a~          multimodal pain management protocol in pediatric post-operative posterior spinal fusion~          patients.~        2. There is no significant difference in the amount of opiate medication required for pain~          control in pediatric post-operative posterior spinal fusion patients.~   "
82471|NCT01977924|"~     Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity~     and mortality. Endothelial dysfunction, an early marker of vascular disease has been~     demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP)~     improves endothelial function and is associated with a reduction in cardiovascular risk.~     Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP.~     Alternative treatments or adjuvants to the CPAP are needed.~      The polyphenols have demonstrated their effectiveness in improving endothelial function in~     patients with CV disease. No randomized controlled studies have evaluated the impact of PPR~     on the endothelial dysfunction associated with OSAHS.~   "
82472|NCT01977911|"~     This study aims to test a new groundbreaking treatment for narrowing of the voicebox and~     upper windpipe, which can be due to injury, inflammatory disease or cancer treatment.~     Narrowing of the voicebox or upper windpipe can leave patients dependant on a tracheostomy~     tube to breath through (a tube or hole in the neck), which can require a high level of care~     with regular hospital visits and can lead to recurrent chest infections. Regular surgical~     procedures may be necessary to widen the airway. Speaking may be very difficult or not even~     possible, breathing is usually a struggle and swallowing can also be affected. Patients feel~     very tired all the time.~      The new treatment tested by this study is an implant that will partially replace the~     voicebox or upper windpipe in order to cure the narrowing. The implant is based on a human~     donor voicebox or windpipe that has been processed with detergents and enzymes in order to~     remove all the cells from the donor, leaving a 'scaffold' of connective tissue. The~     patient's own stem cells are removed from the bone marrow, then are grown on the scaffold in~     the laboratory. These cells will form the cartilage in the wall of the scaffold. A split~     skin graft from the patient may be needed to line the inside of the implant. The implant can~     be considered 'living' due to the cells grown on it, and this type of treatment is referred~     to as 'tissue engineering' or 'regenerative medicine'.~      Once these cells have attached and started to grow on the scaffold, it is ready to be~     implanted into the patient, and an operation is performed which occurs in two separate~     stages. The final stage of the operation involves removing the narrow section of voicebox or~     upper windpipe and implanting the scaffold to reconstruct it. Patients will be followed up~     for two years after this operation, with investigations such as CT scans, examination of the~     voicebox and windpipe with a flexible camera (bronchoscopy) and blood tests performed at~     specific times.~      It is intended that this treatment will significantly improve patients' symptoms resulting~     in better breathing, swallowing and voice function, reducing the need for repeated hospital~     visits and procedures and enhancing patients' quality of life.~   "
82473|NCT01977898|"~     The purpose of this study is to evaluate the use of intrathecal morphine administration~     following an unintentional dural puncture, to decrease the incidence of post dural puncture~     headaches (PDPH) in obstetric patients.~   "
82474|NCT01977885|"~     Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome~     (MetS). Age is an established risk factor for MetS and specific to women, data indicates~     that the prevalence of MetS increases substantially with the menopausal transition with~     postmenopausal women having a 60% increased risk of MetS. Menopause also contributes to~     reductions in strength, physical function and often psychological well-being (e.g. fatigue).~     Obese individuals also have: a) impaired immune function and chronic inflammatory responses~     associated with changes in the white blood cell population in blood and fat tissues; and, b)~     increased secretion of and signaling by proteins in their fat cells. Weight loss, which~     requires an energy deficit through increased physical activity and/or caloric restriction~     (EX+CR), reduces risk for MetS in older sedentary obese women by reducing insulin resistance~     and chronic systemic inflammation. Science and clinical practice will be advanced by~     examining the molecular mechanisms by which EX+CR affects risk for MetS in older women. The~     primary aim is to determine if CD4+ T cells will report the differential epigenetic~     reprogramming of relevant gene expression associated with metabolic indices resulting from~     EX+CR induced weight loss in older women known to be at risk for MetS. This pilot data will~     be used to generate an NIH proposal of the same topic. A secondary aim is to assess the~     impact of weight loss on physical function and psychological well-being which will provide~     pilot data for an additional grant proposal regarding weight management in postmenopausal~     women.~   "
82475|NCT01977872|"~     JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized~     controlled trial evaluation of a physical activity and nutritional worksite intervention to~     decrease symptoms and disability associated with knee osteoarthritis (OA), a major public~     health problem and a leading cause of work disability and work absenteeism/presenteeism in~     the US workforce.~      The overarching goal of this project is to find an effective and sustainable intervention~     strategy that can assist large populations of persons with or at risk for knee OA to attain~     and maintain healthy dietary and physical activity behaviors. This project has to potential~     to have a tremendous impact on improving symptoms and quality of life of persons with~     chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism,~     and soaring healthcare utilization associated with knee OA.~   "
82476|NCT01977859|"~     The purpose of this study is to collect data to help researchers better understand the~     various causes of obesity, which may lead to the development of new obesity treatment~     options.~   "
82477|NCT01977846|"~     Stargardt disease is currently an incurable and untreatable macular dystrophy that causes~     severe visual loss in children and young adults, thereby causing enormous morbidity with~     economic, psychological, emotional, and social implications. There are no FDA approved~     therapeutic treatments for this disease. Therefore, the objective of this study is to~     collect natural history data from a large population of children and adults in order to~     evaluate possible efficacy measures for planned clinical trials.~      Participants will be recruited from each Investigator's own patient population as the study~     requires the availability of both multiyear retrospective data, as well as ongoing~     prospectively collected data. A concurrent ancillary study (SMART study) is also being~     conducted with a subset of the prospective study patients during their regular ProgSTAR~     study visits to expand the collection of retinal images to include microperimetry~     measurements gathered under scotopic (low light) conditions.~   "
82478|NCT01977833|"~     Enhanced insulin and GLP-1 postprandial response after morning meal versus evening meal,~     might be underlying explanation of the beneficial effect of eating breakfast with reduced~     dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.~      To test this hypothesis and clarify whether glucose, insulin and GLP-1 postprandial~     responses are different in the morning vs. in the afternoon, the investigators will compare~     in T2D subjects in random order and in two separate days: the glucose, insulin and GLP-1~     postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or~     test diets, that differ in meal timing distribution The investigators hypothesize that GLP-1~     and insulin response after high calorie breakfast will be higher in comparison to GLP-1 and~     insulin response after identical meal at evening~   "
82479|NCT01977820|"~     This is a Phase 2a multicenter, double-blind, placebo-controlled, randomized, 2-arm pilot~     trial designed to assess the effect of sapropterin on cognitive abilities in young adults~     with Phenylketonuria (PKU) over a 26-week treatment period.~   "
82480|NCT01977807|"~     This clinical study has been planned to evaluate the safety and effectiveness of common~     treatment algorithms using 500 Hz laser repetition rate.~   "
82481|NCT01977794|"~     This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose~     combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC~     over monotherapies).~   "
82531|NCT01977144|"~     The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS)~     on patients with low ovarian reserve in an effort to improve success during in vitro~     fertilization and decrease the time to successful pregnancy.~   "
82482|NCT01977781|"~     The purpose of this study is to evaluate the safety and tolerability of topical tacrolimus~     0.05% twice a day in the treatment of ocular graft versus host disease (GVHD). A secondary~     objective is to compare the efficacy of topical tacrolimus 0.05% drops compared with topical~     methylprednisolone sodium succinate 0.5% drops in patients with ocular GVHD. 40 patients~     with ocular GVHD who meet the inclusion criteria of the study as determined by a screening~     visit will be divided into two equal groups. In addition to their current medication, one~     group will receive the topical tacrolimus 0.05% drops and the other group will receive the~     topical methylprednisolone sodium succinate 0.5% drops. The participants will then have two~     follow-up visits at the week 5 and week 10 markers after their screening visit.~      To evaluate the purpose of the study as well as the patient's safety, the following~     procedures will be performed at each visit: a comprehensive eye examination, tear break-up~     time (TBUT), Schirmer's test, intraocular pressure (IOP), fundoscopy and grading scores of~     lid margin and corneal fluorescein staining. The following questionnaires will be~     administered at each visit: Ocular Surface Disease Index (OSDI) and Symptom Assessment in~     Dry Eye (SANDE). Impression cytology specimens will be taken only at the screening visit and~     at the week 10 visit.~   "
82483|NCT01977768|"~     The purpose of the study is to identify optimally effective dose of whole-cell, heat-killed~     Mycobacterium vaccae formulated as a pill and consequently carry out multi-country,~     placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug~     resistant (MDR-TB) and TB-HIV.~   "
82484|NCT01977755|"~     This study explores the potential cardioprotective properties of danegaptide when~     administered to patients with ST-Segment elevation myocardial infarction.~   "
82485|NCT01977742|"~     Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training~     over the cardiac vagal of cardiac patients in a supervised exercise program.~   "
82486|NCT01977729|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) in~     combination with sertraline (SRT) is more effective than SRT alone in treating children and~     adolescents with anxiety disorders (after an initial 8 weeks of CBT).~   "
82487|NCT01977716|"~     The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk~     factors for loss of residual renal function, technique failure and mortality in chronic~     kidney disease patients.~      Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis~     population and to understand the bacteriological profile of peritonitis.~      To know the rate and risk factors other than peritonitis involved in the loss of residual~     renal function.~      To analyze the utility of alternative diagnostic tests, such as reagent strips, for early~     detection of peritonitis when traditional tests are not available.~      To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative~     measurements of peritoneal clearance and residual renal function.~   "
82488|NCT01977703|"~     We propose to study a strategy empirically applied for the past 6 months at a high volume~     LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative~     device programming strategy to maximize battery longevity, avoid inappropriate implantable~     cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in~     overall shock burden, and potentially avoid unnecessary device generator changes prior to~     transplant. Avoiding CIED (cardiac implantable electronic device) change out device~     procedures prior to transplant is desirable.~   "
82489|NCT01977690|"~     The purpose of the study is to see whether a clavicle splint can decrease the pain after~     posterior cervicothoracic surgery. The term cervicle splint conveys that the investigators~     do not deal with clavicle fractures here but use the splint he stabilize the posterior~     cervical area.~      The investigators want to demonstrate this in a prospective randomized manner.~   "
82490|NCT01977677|"~     This pilot phase I/II trial studies the side effects and best dose of plerixafor after~     radiation therapy and temozolomide and to see how well it works in treating patients with~     newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking~     blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor~     after radiation therapy and temozolomide may be an effective treatment for high grade~     glioma.~   "
82491|NCT01977664|"~     Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles.~     Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated~     oocytes.~   "
82492|NCT01977651|"~     The objective of this study is to evaluate the incidence of seizures and monitor the safety~     of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer~     known to have risk factor(s) for seizure.~   "
82493|NCT01977638|"~     The purpose of this study is to determine the highest dose of CXD101 (a novel histone~     deacetylase inhibitor) that can be safely administered to patients with advanced tumours.~     The study will also investigate the use of HR23B expression in tumour as a biomarker of~     response to treatment with CXD101. Patients with solid tumours, lymphoma and myeloma can be~     considered for this study.~   "
82494|NCT01977625|"~     This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on~     executive function and prefrontal cortex activation in menopausal women ages 45-57, who~     report subjective cognitive difficulties. This protocol will recruit women from Dr.~     Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation~     during performance of cognitive tasks specifically probing prefrontal cortex function.~   "
82495|NCT01977612|"~     Women with gynecologic cancers are often obese and have other risk factors for~     post-operative wound separation. Data from obstetrics and orthopedic surgery literature have~     shown a decreased risk of wound separation and complications when the skin is closed with~     suture as compared to staples. Skin closure with either staples or suture is considered~     standard of care. Traditionally, most wounds have been closed with staples given their ease~     of use and quick application. In this randomized study the investigators plan to evaluate~     and compare the complication rate associated with both standard closures.~   "
82532|NCT01977131|"~     The aim of this study was to analyze the safety, pulmonary function, and imaging changes of~     patients with silicosis treated with autologous bone marrow stromal cells with modification~     by hepatocyte growth factor.~   "
82496|NCT01977599|"~     Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer~     deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early~     stages of development, during which time it is more easily treatable. Unfortunately, many~     patients do not attend screening, and surveys issued to these women consistently report~     forgetfulness as the primary reason for missing the appointment. Both telephone reminders~     and postal reminders have been shown to reduce non-attendance, however, these are time~     consuming and expensive.~      Mobile telephones are becoming an increasingly popular tool for communication between~     healthcare professionals and patients, one which might offer an inexpensive solution for~     delivering reminders. Text message reminders have been able to prevent missed appointments~     in other areas of healthcare, and the same might be true for breast screening.~      The investigators are conducting a trial to confirm whether this is the case or not.~      In this trial, the investigators will send some women a text message to reminder them of~     their appointment, and other women no reminder for their appointment. The investigators will~     then compare the number of women in each group that went to their breast screening~     appointment.~   "
82497|NCT01977586|"~     The aim of this study is to assess whether functional magnetic resonance imaging (MRI)~     techniques are able to detect which patients with metastatic renal cell carcinoma will~     derive benefit from treatment with anti-angiogenic drugs early in their treatment. Early~     response assessment would allow selection of the most appropriate treatment option for each~     individual patient.~   "
82498|NCT01977573|"~     This study will be conducted in approximately 228 subjects with anemia associated with CKD~     who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1:~     recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are~     currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either~     GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO~     before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to~     the control arm. For those randomized to the control arm, the decision around whether the~     subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of~     rhEPO dose to achieve and maintain Hgb concentrations within the target range should be~     based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb~     value being considered. The study consists of a screening phase of at least 4 weeks, a~     24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after~     completing treatment. It is anticipated that the data generated will enable selection of the~     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.~   "
82499|NCT01977560|"~     The purpose of this study is to determine the effect of lifestyle intervention on metabolism~     and blood sugar control in Type 2 Diabetics.~   "
82500|NCT01977547|"~     ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC~     storage duration in 1538 critically ill children. Laboratory and observational evidence~     points to serious concerns about the lack of safety and effectiveness of older RBCs,~     especially in more vulnerable populations. Physicians and institutions have been~     systematically transfusing fresh RBCs to some pediatric patients primarily because of~     beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of~     blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide~     much needed high quality evidence to answer the question do RBCs of reduced storage~     duration improve outcomes? The ABC PICU Trial will conduct a RCT comparing development of~     New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children~     transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC~     storage duration of 17-21 days).~   "
82501|NCT01977534|"~     The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS~     for daily use in patients with de novo lesions in previously untreated vessels.~   "
82502|NCT01977521|"~     The present study aims to examine the efficacy of transcranial direct current stimulation on~     the severity of auditory hallucinations.~   "
82503|NCT01977508|"~     Multicentre, prospective, observational post-market registry. To monitor and collect data on~     the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access~     Graft.~   "
82504|NCT01977495|"~     The investigator plans to assess enrollment rates among two different enrollment methods,~     while providing a behavioral economic intervention to enhance the uptake of home-health~     monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The~     study is focusing on enrollment methods since the standard randomized control trial only~     reaches 15% of the population. The study is seeking to understand the effectiveness of a~     behavioral intervention, when rolled out in a larger population.~   "
82505|NCT01977482|"~     This study is intended to evaluate the dose-response relationship of GSK1278863 over the~     first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks~     to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia~     associated with chronic kidney disease (CKD) who are switched from a stable dose of~     recombinant human erythropoietin (rhEPO). The data generated will enable selection of the~     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.~   "
82506|NCT01977469|"~     The local and systemic manifestations that affect patients with Chronic Obstructive~     Pulmonary Disease (COPD) cause severe dyspnoea and limitation of functional capacity,~     leading to impairment in the performance of activities of daily living (ADL). The~     combination of aerobic and resistance training, for both upper limbs (UL) and lower limbs~     (LL), appears to be the physiologically most complete resource for improving quality of life~     and increased survival of these patients. Therefore, the aim of the study is to assess the~     impact of aerobic and resistance training of different intensities on the performance and~     dyspnoea during activities of daily living and prediction of mortality in patients with~     COPD. There will be include 30 COPD patients with moderate to severe obstruction, aged~     between 50-80 years of both gender. All patients will undergo to the following assessments~     and reassessments: history and anthropometric data, Scale London Chest Activity of Daily~     Living Scale (LCADL), modified Medical Research Council (mMRC), BODE index, test peripheral~     muscle strength, mobility and balance tests, 6-minute walk test (6MWT), Circuit ADL Test, 1~     repetition maximum (1RM) and Incremental Cardiopulmonary Testing (ICPT). Patients will be~     randomly divided into two groups and undergo to the treatment program will consist of~     sessions lasting approximately 1 hour, three times a week for 12 consecutive weeks, totaling~     36 sessions. All patients will undergo general stretching and aerobic training on a cycle~     ergometer with the intensity between 70-80 % of the maximum load achieved in ICPT. After~     aerobic training, a group of patients will achieve a protocol of low-intensity resistance~     training (LI-RT), with emphasis on gaining muscle strength, and the other group will be~     submitted to a protocol of high intensity (HI-RT), aiming greater gain in muscle strength.~     The calculation of the intensity of training will be conducted by the 1RM test. After the~     training protocol, it is expected to find improved performance and dyspnoea during~     activities of daily living and reduction of BODE index for both groups, however, it is~     expected that the group of low-intensity resistance training presents greater benefits in~     ADL.~   "
82509|NCT01977430|"~     Introduction: Chronic kidney disease is characterized by a progressive deterioration of~     renal function. At the end of the progression, when complications occur (overhydration,~     electrolyte imbalances or retention of uremic toxins), a percentage of patients requiring~     renal replacement therapy (haemodialysis). When starting the haemodialysis, the patient~     holds the residual renal function (RRF) which is lost over time. To preserve the RRF, the~     patient is treated with diuretics loops and / or thiazide diuretics. The effect of this~     treatment is lost when renal function worsens. In this context, there are few studies that~     explore the use and effectiveness of diuretics in patients on haemodialysis 2. Objectives~     and Hypothesis:~      Hypothesis: The treatment with furosemide and hydrochlorothiazide in haemodialysis patients~     with RRF could:~        -  To decrease in weight gain between haemodialysis sessions.~        -  To increase urine volume.~        -  To decrease the ultrafiltration in haemodialysis sessions ( the long interdialytic~          interval)~      Main Objective:To asses the effect of combined hydrochlorothiazide-furosemide therapy on~     gain weight between haemodialysis sessions in patients with RRF~      Secondary Objective: To asses the effect of combined hydrochlorothiazide-furosemide therapy~     on dialytic, clinical and analytical variables and use of the antihypertensive treatment~      3. Methodology: Randomized open clinical trial to compare the effectiveness of the~     administration of diuretics in haemodialysis patients with residual renal function in single~     centre.~      The population of study are patients with chronic renal disease in haemodialysis therapy~     that they preserve residual renal function ( more 200ml daily of urine). It will be a simple~     randomization, to asses the effect of combined hydrochlorothiazide-furosemide therapy~      After a of 15 days washout without diuretic treatment, patients will be randomized to~     receive or not receive combined diuretic treatment for 1 month. After a 1 month washout ,~     the patients will be receive or not the treatment according to cross over trial.~   "
82510|NCT01977417|"~     Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar~     response to sugar ingestion, effects over 79 million adult Americans and is a precursor to~     the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have~     diabetes and 32% (670,000) have prediabetes with the majority of those with prediabetes~     going undiagnosed. Adults with prediabetes demonstrate early signs of cardiovascular and~     nervous system abnormalities and are at high risk for developing overt diabetes unless~     aggressive lifestyle (weight loss, exercise) or pharmacological interventions are employed.~     Interestingly, data in recent years has linked obesity and diabetes to chronic inflammation~     of the blood vessels and brain areas that regulate blood pressure. Therefore, the current~     study will test whether a commonly used aspirin-like anti-inflammatory drug called~     salsalate, will improve blood vessel health and nervous system dysfunction in adults with~     prediabetes. Eligible subjects will have measurements of blood pressure, blood vessel~     function in the arms and eyes, assessments of nerve activity, and blood samples taken before~     and after 4 weeks of ingesting an FDA approved aspirin-like drug called salsalate. The study~     is important because it will identify a potentially new pharmacological strategy to treat~     vascular and nervous system abnormalities in overweight and obese adults with early stage~     type 2 diabetes using an inexpensive, generically available drug with an excellent safety~     record that has been used for decades to treat chronic inflammatory conditions such as~     rheumatoid arthritis. If proven effective, this will provide preliminary support for the~     concept of targeting inflammation as a new clinical approach to treating early diabetes~     related complications. Furthermore, the current pilot study will provide support for~     developing a larger clinical trial using salsalate that could potentially then be extended~     to patients with type 2 diabetes and cardiovascular disease, as well as lead to the~     development of new anti-inflammatory agents with greater specificity for selective~     inflammatory pathways.~   "
82511|NCT01977404|"~     This study objective is to assess the nutritional status of Patients With Congestive Heart~     Failure.~   "
82512|NCT01977391|"~     Diabetes mellitus is known to increase the risk of premature death in the general~     population. In this study, the investigators examine the impact of body mass index (BMI)~     levels, waist circumference, and presence/absence of diabetes on all-cause and~     cardiovascular mortality in elderly Koreans.~   "
82513|NCT01977378|"~     A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release~     Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult~     with major depressive disorder.~   "
82514|NCT01977365|"~     Hypothesis N°1: The children growth promotion based on approach centered on their specific~     needs enhances caretakers and health workers skills, knowledge and practices on~     breastfeeding, complementary feeding and child care.~      Hypothesis N°1: children growth promotion based on approach centered on their specific~     needs approach improves children growth and health.~   "
82515|NCT01977352|"~     The purpose of this study is to compare the quality and duration of pain relief after~     shoulder surgery provided by a single injection of liposomal bupivacaine versus standard~     bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized~     that the liposomal bupivacaine formulation will provide more effective pain relief than~     standard bupivacaine.~   "
82516|NCT01977339|"~     The purpose of this study is to compare the quality and duration of pain relief after a~     total knee replacement provided by a single shot of standard bupivacaine versus a single~     shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the~     liposomal bupivacaine formulation will provide more effective pain relief than standard~     bupivacaine.~   "
82517|NCT01977326|"~     The objective of this randomised controlled trial (RCT) is to determine the effectiveness~     and cost-effectiveness of a task sharing counseling intervention for maternal depression in~     South Africa(i.e. provided by non-specialist health workers)~   "
82518|NCT01977313|"~     It is known that with increasing age sexual desire is declining in women. Decreasing levels~     of androgens are believed to have an influence, but cannot explain the loss of libido~     completely. A possible explanation might be that the effect of the androgen is depending on~     the functionality of the androgen receptor. It is known that this functionality is~     genetically determined by the polymorphism of the androgen receptor gene. In the gene there~     is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality~     of the androgen receptor, the lower the effect of the androgens. In this pilot study, the~     investigators would like to invite 45 healthy heterosexual middle-aged women to the~     University Hospital of Bern, where they answer questionnaires about their sexual function~     and where they give a blood sample to assess the testosterone serum levels and the~     genetically determined androgen receptor subtype.~      The investigators believe that lower androgen levels and/or longer CAG-repeats in the~     androgen receptor gene are related to lower libido scores in healthy middle-aged women.~   "
82519|NCT01977300|"~     Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood~     Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and~     recurrence of mood episodes compared to discontinuing the antipsychotics within days of~     resolution of manic symptoms.~   "
82533|NCT01977118|"~     Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic~     necrosis with or without peripancreatic collection.~      Percutaneous catheter drainage successfully drains the liquefied component of pancreatic~     necrosis while the solid component still remains undrained. This infected solid component of~     pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage~     which demands surgical debridement.~      Streptokinase is a protein secreted by several species of streptococci which can bind and~     activate human plasminogen.~      In the present study investigators plan to instill streptokinase locally in to the~     collections of patients with severe acute pancreatitis via pigtail catheter inorder to~     liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby~     delays or obviates the need for necrosectomy.~   "
82534|NCT01977105|"~     This is a single-group feasibility pilot trial of a peer-based, social media intervention to~     prevent obesity in infants.~   "
82520|NCT01977287|"~     This investigation consists of two parallel groups of participants who will follow the same~     protocol. The aim of the study is to investigate the effects of using Functional Electrical~     Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12~     week period in people with MS who experience foot drop. Patients who are clinically~     prescribed FES will be invited to participate in the FES arm of the study. Patients who are~     clinically prescribed an AFO will be invited to participate in the AFO arm. Participants~     will be asked to make four visits to the gait laboratory at Queen Margaret University. Four~     weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline),~     after 6 weeks and 12 weeks of device use. Participants' walking will assessed using~     computerised three dimensional motion analysis, which will provide a detailed description of~     the movements (kinematics) of the lower limbs. Participants will also be asked to carry out~     a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests~     will be carried out with and without an assistive device; apart from their first session~     where participants will only be assessed without their assistive device.~      Participants will be asked to wear an activity monitor for 7 days after each assessment. In~     addition participants will be asked to complete four short standardised questionnaires (MS~     walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of~     life score) at each assessment.~   "
82521|NCT01977274|"~     Research of predictive clinical and biological factors in breast cancer : genomic,~     proteomic, mutation~   "
82522|NCT01977261|"~     A prospective, randomised, controlled trial compared two different techniques of high tibial~     osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu~     plate. The clinical outcome and radiological results were examined at one year.~   "
82523|NCT01977248|"~     The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills~     group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental~     social skills necessary to build and maintain relationships. The manualized curriculum~     addresses skills such as joint attention, eye contact, play, and peer engagement. Currently~     individual goals are set for each child who participates and this is documented in the daily~     treatment note. In order to research group outcomes, the investigators will use parent~     questionnaires (an addition to current clinical practices) to measure changes in behavior~     after each 12 week session for up to one year of treatment. The investigators hypothesize~     that maladaptive behaviors will decrease and adaptive behaviors will increase in children~     with ASD after participation in the SMART program.~   "
82524|NCT01977235|"~     As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is~     related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7)~     and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and~     *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out~     the efficacy and side effect between two different dosages of irinotecan combined with~     cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and~     6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6~     (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the~     efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and~     6/7)*6 (G/G and G/A).~   "
82525|NCT01977222|"~     Mechanisms that typically result in increased cardiac output, such as inotropic support,~     increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation.~     The thoracic pump is a contributor to venous return that has been largely unexplored in~     patients with Fontan physiology. Inspiratory muscle training can improve the performance of~     competitive athletes across a range of sports and can improve quality of life and functional~     capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and~     possibly by improving peripheral blood flow during exercise. One could surmise that the~     effects of these changes would be particularly important in the Fontan population. The~     investigators propose to study the effects of inspiratory muscle training on exercise and~     pulmonary function parameters in a cohort of adult Fontan patients.~      The investigators hypothesize that a 12-week program of inspiratory muscle training with an~     inspiratory impedance threshold device will improve inspiratory muscle strength and~     endurance, and that this will translate into improved exercise performance in patients with~     Fontan physiology.~   "
82526|NCT01977209|"~     The investigators' experimental study found that gossypol was the natural inhibitor of~     apyrimidinic endonuclease 1 (APE1) and clinical study observed that high expression of APE1~     was relative to the platinum-resistance in non-small cell lung cancer. Thus the purpose of~     this study is to find out whether gossypol can improve the sensitivity of cisplatin-based~     chemotherapy in the non-small cell lung cancer with apurinic apyrimidinic endonuclease 1~     (APE1) high expression~   "
82527|NCT01977196|"~     The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine~     and immediate reactions within the first 30 minutes after injection.~   "
82528|NCT01977183|"~     The purpose of this clinical trial is to study the effects of potato resistant starch on the~     microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut.~     Levels will be measured and compared between elderly adults and in pre-elderly, adults from~     the general public. A correlation between the use of potato resistant starch and specific~     clinical and quality of life endpoints between elderly adults and in pre-elderly, adults~     from the general public will be studied.~      Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70~     years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the~     general population and that this imbalance of the gut microflora in the elderly adults is~     partially related to inadequate RS in their diet.~      Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of~     food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high~     Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the~     general population), thereby improving gut health and reducing the risk of diarrhea and/or~     gut infection.~   "
82529|NCT01977170|"~     The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate~     reactions within the first 30 minutes after injection.~   "
82530|NCT01977157|"~     Examination if the bioimpendanz measurement can be used for the determination of the alcohol~     content in human blood.~      Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer~     and one blood test.~   "
82535|NCT01977092|"~     The goal of the study is to see if a Motivational Interviewing Case Management (MICM)~     intervention will improve outcomes for respondents who are on probation or parole, at risk~     for HIV and have recently entered a Sober Living House. The MICM will help respondents~     access needed services, adapt to their new living environment, find and maintain work,~     address HIV risk and treatment, and manage setbacks. The risk for HIV infection among~     criminal justice offenders is significant, as is the need for stable, drug free housing in~     this population. Our aim is to see if the MICM intervention in the context of drug free~     housing will improve health outcomes, reduce recidivism, and increase service utilization~     for this population.~   "
82536|NCT01977079|"~     Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of~     premature birth (PB) before 37 weeks is about 42%, which reflects the inability to~     accurately identify patients at high risk of PB. Currently, no clinical or biological marker~     is recognized as the most reliable in predicting the real risk of AP in case of MAP.~      The purpose of this study is to improve the knowledge of predictors of preterm delivery~     compared with conventional blood markers by estimating serum procalcitonin according to~     premature delivery or not in patients hospitalized for preterm labor .~   "
82537|NCT01977066|"~     The purpose of this study is to compare the effects of two specific exercise interventions~     and one standard care control arm on physical functioning.The investigators expect that~     supervised training is most beneficial to the patients. However, they also expect some~     benefit for patients in the home-based training.~   "
82538|NCT01977053|"~     In health care, the phone has emerged as a clinical tool in its own right, especially for~     the development of psychological support to patients and that, in many pathologies. Its~     potential in the development of psycho-social support was quickly identified.~      However, to our knowledge, no prospective, randomized studies have evaluated the impact of a~     telephone call to both the anxiety and the management of side effects of neoadjuvant or~     adjuvant chemotherapy.~      The patient incomplete care by the hospital system and the general practitioner during~     chemotherapy, as well as the lack of information and poor preparation and / or management of~     side effects, are a source of distress and lead to a decrease quality of life for the~     patient and his family.~      We propose to determine on a population of 280 patients, the impact of two phone calls~     during 3 first inter-treatment intervals on the overall measure of mood states of the~     patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force~     and interpersonal relation). We will also study the gain in quality of life, on anxiety~     level, frequency and severity of toxicities, as well as emotional comfort of the procedure.~   "
82539|NCT01977040|"~     This is a multicenter retrospective observational study of women diagnosed with a vasa~     previa during pregnancy or at delivery who delivered between 2000 and 2012. The study hopes~     to be able to describe techniques utilized to screen for and diagnose vasa previa as well as~     to describe the maternal characteristics and identify potential underlying risk factors that~     may provide a basis for future screening recommendations for vasa previa and treatment~     protocols.~   "
82540|NCT01977027|"~     Motor learning can be affected by the sensory difficulties that may be experienced as a~     result of a stroke. This study will help us better understand what kinds of sensory~     information can help with the re-learning of grasping with the affected hand despite the~     sensory difficulties produced by the stroke.~   "
82541|NCT01977014|"~     This observational study aims to chart patients which get their prostacyclin treatment via~     the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical~     follow-up of these patients. And by this also charting complications that might occur in~     relation to treatment.~      Participating centres are located in Denmark, Norway and Sweden.~   "
82542|NCT01977001|"~     MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of~     MigraineBoxTM will be studied in primary headaches in the emergency department. The user~     simply reclines his/her head and neck into this device that has contours that support the~     head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen~     insert is placed inside. This will gradually cool the water surrounding the patient's head~     and theoretically provide headache relief.~   "
82543|NCT01976988|"~     Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous~     thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist~     et al. Dis. Col. Rectum. 2006; 49: 1620-1628.)~      The reported incidence of symptomatic VTE after colorectal surgery is approximately 4%~     (Monn, F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after~     colorectal surgery in prospectively followed patients managed with perioperative venous~     thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9~     to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000:~     438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.~      The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician~     (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of~     surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather~     than in the postoperative period, justifying preoperative initiation of venous~     thromboprophylaxis. This practice is accompanied with a theoretically higher risk of~     bleeding complications.~      Currently there is no consensus on the precise timing of VTE prophylaxis after major~     colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and~     SCIP. Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis.~     However, majority of surgeons at our institution begin heparin postoperatively given concern~     for bleeding complications with preoperative dosing of heparin.~      The purpose of this study is to prospectively evaluate the incidence of VTE and major~     bleeding complications in patients undergoing major colorectal surgery who are treated with~     preoperative or postoperative venous thromboprophylaxis and to help establish more stringent~     guidelines on the optimal timing of VTE prophylaxis.~   "
82544|NCT01976975|"~     This study aims to investigate reward learning across the mood disorder spectrum and to~     investigate the predictive validity of reward learning for subsequent symptom severity.~   "
82545|NCT01976962|"~     To improve radiation therapy of prostate cancer, the investigators must be able to~     accurately identify the tumour. By using advanced functional imaging techniques available on~     state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the~     prostate, the investigators can use advanced radiation therapy techniques to specifically~     target the tumor and control it with as few radiotherapy clinic visits as possible. This is~     different than current techniques which treat the whole prostate gland to the same dose,~     delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to~     the active tumor while still maintaining adequate radiation dose to the rest of the~     prostate, the investigators hope to better control prostate cancer and reduce complications~     to nearby normal tissues.~   "
82546|NCT01976949|"~     It is hypothesized that the treatment group will show greater improvements in quality of~     life and mood disturbance compared to the control group and that greater levels of~     engagement with the intervention materials will be associated with greater improvements in~     mood and quality of life.~   "
82547|NCT01976936|"~     This trial will be a phase 2 randomized safety study in which ischemic stroke patients will~     be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin~     versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of~     this Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and~     laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will~     include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional~     outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory~     markers and lipid levels will also be assessed.~   "
82548|NCT01976923|"~     The purpose of this is study is to assess the efficacy of pre-operative intravitreal~     bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing~     operative time, complications, intra-operative and post-operative hemorrhage following small~     gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge~     PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD)~     secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be~     beneficial for membrane dissection in diabetic tractional retinal detachment with minimally~     invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In~     addition, post-operative rebleeding may be decreased.~   "
82549|NCT01976910|"~     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated~     antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models,~     acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive~     impairment/neurotoxicities were noted in mouse and rat models.~      The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the~     latter which has been documented - chemically and biologically to be stable and safe.~     Patients are currently being enrolled and treated with the protocol.~      Patients with advanced cancer, with or without central nervous system involvement will be~     eligible for enrollment, providing the required blood and other eligibility requirements are~     met.~   "
82550|NCT01976897|"~     The main objective of this study is to evaluate the relationship between the angle of knee~     flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure~     at the heel area (PtAl).~   "
82551|NCT01976884|"~     Immunosuppression is the leading cause of death in septic patients. Neutrophils are~     classical components of innate immunology, but recent studies showed that neutrophils might~     display antigen presenting function and inhibit lymphocyte proliferation by expressing~     programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in~     immunosuppression during sepsis remain unclear.~   "
82552|NCT01976871|"~     The primary objective is to demonstrate safety and tolerability of switching patients with~     Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.~      As a secondary objective, the investigators will evaluate control of RLS symptoms on~     rotigotine compared to the prior oral regimen.~   "
82553|NCT01976858|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.~   "
82554|NCT01976845|"~     The purpose of this research is:~      To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety),~     and amnesic (produces temporary lack of recall) effects of propofol or midazolam when~     administered for preoperative medication (before administration of drugs that will put~     patient to sleep) in comparison to placebo. This study is to test whether the use of the~     pre-anesthesia medication measurably reduces anxiety in comparison to receiving no~     pre-anesthesia medication prior to orthopedic procedures.~      To assess the effect of propofol in comparison to placebo and midazolam on the ability to~     recall (memory of):~        -  when the doctor places the mask on patient's face prior to going to sleep~        -  recall of 2 pictures~        -  on your satisfaction with the anesthesia as well as postoperative side effects in~          post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.~   "
82555|NCT01976832|"~     This study intends to use music and movement (MWM) to reduce anxiety and behavioral symptoms~     of people with early dementia (PWD) and their family carers in the community. It also aims~     to examine whether MWM can enhance the sleep quality of PWD and their family caregivers and~     promote their well-being.~      This is a mixed methods study with the quantitative paradigm being the main research~     approached used. The quantitative arm will be a randomized controlled trial (RCT). The~     qualitative arm will adopt a naturalistic approach through interviewing for data collection.~     Recruited subjects from the community centres of non-government organizations (NGOs) will be~     randomly allocated to the intervention and control group.~      The outcome measures of the PWD will include Rating Anxiety in Dementia (RAID), Geriatric~     Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Pittsburgh Sleep~     Quality Index (PQSI), Quality of Life - Alzheimer's Disease (QOL-AD), Mini-Mental State~     Examination (MMSE), Revised Life Event Scale (RLES), Modified Brathel Index (MBI) and~     Non-pharmacological Therapy Experience Scale (NPTES), whereas the outcome measures of the~     family caregivers will be Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety~     Disorder 7 (GAD-7), Zarit Burden Scale (ZBD), Pittsburgh Sleep Quality Index (PSQI), Reverse~     Life event Scale (RLES), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).~      To address the research questions, data will be collected at baseline (T0), immediately~     post-intervention at 8-weeks (T1), and 8 post-intervention (T2). The qualitative arm of this~     study will contribute to the understanding of issues and effects of MWM as an intervention.~     Its finding will complement the results obtained from the RCT.~   "
82556|NCT01976806|"~     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in~     the treatment of periodontitis in adults.~   "
82557|NCT01976793|"~     This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with~     an initial antidepressant taken as monotherapy in patients in whom treatment was changed~     because of suboptimal response at physician's discretion. This will address unmet medical~     needs of patients with a depressive episode related to RDD (ICD-10, Version 2010), who have~     failed to respond adequately to initial treatment with an antidepressant and contribute to~     an understanding of the usual approaches that physicians adopt to monitor initial treatment~     efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line~     therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.~   "
82561|NCT01976741|"~     -  This is the first study where BAY1163877 is given to humans. Impact of the study is to~          evaluate if patients with advanced solid cancers show advanced clinical benefit under~          the treatment with the pan FGFR inhibitor. Patients (all comers) will receive the study~          drug treatment in a dose-escalation scheme (no placebo group) to determine the safety,~          tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative~          bioavailability of liquid service formulation and tablets will be determined.~        -  After the MTD is defined patients with solid tumors (all comers), lung cancer (lung~          adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder~          cancer will be enrolled according to their FGFR expression profile (biomarker~          stratification).~        -  The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic~          parameters and tumor response of BAY1163877.~        -  BAY1163877 will be given twice daily as oral application. Treatment will be stopped if~          the tumor continues to grow, if side effects, which the patient cannot tolerate, occur~          or if the patient decides to exit treatment.~   "
82562|NCT01976728|"~     To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic~     hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the~     OmniPod pump versus placebo~   "
82563|NCT01976715|"~     Background:~      - The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS).~     Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease~     the amount of HIV virus in the blood (called viral load) to very low levels. This happens~     only if the drugs still fight HIV and if taken every day exactly as prescribed. When not~     taken as directed, or if the ART drugs are not strong enough, the virus can become resistant~     to them, and the ART will not work to control the virus. Researchers want to know how to~     control HIV in people who can t lower their viral load with their current ART drugs.~      Objective:~      -<TAB>To better control HIV in people who can t get a lower viral load even with ART drugs~     and to learn more about why the HIV is not under control.~      Eligibility:~        -  People at least 14 years old and with HIV.~        -  People who have been on at least two combinations of ART drugs (including current ART).~        -  People whose last two viral loads were greater than 1,000 copies/mL.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will then have a baseline visit. They will have another physical exam,~          blood tests, plus answer questions about what they know about HIV and ART, and how they~          take their ART.~        -  Participants will arrange to stay in the NIH hospital for 7 8 days.~        -  They will take their medications as usual. At the time to take the ART drugs, they will~          have to ask a nurse to bring them. If they forget, the nurse will bring them.~        -  Participants will meet with a doctor, pharmacist, social worker and nurse to discuss~          ways to help participants remember to take their drugs.~        -  Participants will have blood drawn about every other day.~        -  Researchers will study the test results. Some participants will be put on different ART~          drugs. If that happens, participants will have another NIH hospital stay for 7-8 days.~        -  Participants will have 4 follow-up visits over 12 weeks, then every 3 months for 2~          years or more.~   "
82564|NCT01976702|"~     This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an~     Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and~     attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the~     original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen~     relationship-based social competency skills of the original BST that were crucial in~     sustaining adherence to protective behavior.~   "
82565|NCT01976689|"~     New-onset diabetes (NODAT) after solid organ transplantation is an important clinical~     challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal~     disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has~     been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood~     pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality.~     Both LVH and arterial stiffness are independent determinants of CV disease in patients with~     ESRD. The aim of this study is to evaluate the relationship between post-transplant~     new-onset diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney~     transplant recipients.~   "
82566|NCT01976676|"~     Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein~     level more efficiently than folic acid. On the other hand, folic acid is currently an~     important part of treatment in idiopathic recurrent abortion. There is no study comparing~     the effectiveness of these supplements in the treatment of recurrent abortion. The aim of~     this study is to compare the efficiency of these two agents in the treatment of recurrent~     abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna~     clinic will be randomly allocated into two groups of those taking either folic acid (5 mg)~     or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum~     level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two~     groups.~   "
82567|NCT01976650|"~     This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy~     of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein~     Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior~     segment of the eye in clinical practice.~   "
82568|NCT01976637|"~     Leg compression is considered the basic treatment for superficial vein thrombosis (SVT).~     However, its use is more or less based on subjective experience while scientific evidence~     for its efficacy is lacking. There is one uncontrolled trial reporting improvement of~     clinical symptoms when patients with SVT were treated with fixed compression bandages.~      This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT~     of the legs. The investigators hypothesis is that compression treatment is superior to no~     compression in alleviating disease related clinical symptoms.~   "
82569|NCT01976624|"~     This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of~     bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular~     hypertension in Korea.~   "
82570|NCT01976611|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.~   "
82571|NCT01976598|"~     To explore the optimal stimulation parameters and locations for sub-perception programming~     in patients with previously implanted spinal cord stimulation systems for the treatment of~     chronic back and/or leg pain.~   "
82605|NCT01976156|"~     The aims of this project are to determine if dietary supplementation with NOPE-EGCG~     (PhosphoLeantm, 30mg NOPE+20mg EGCG per capsule) can:~        -  rescue striatal function,~        -  increase adherence to a diet,~        -  reduce weight-gain after a diet,~        -  improve performance on impulsivity, go/no-go tasks, and negative outcome learning, and~        -  shift fat and sweet preference in overweight/obese human subjects in a double-blind~          cross-over design.~   "
82606|NCT01976143|"~     The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc~     interval in patients with advanced or metastatic solid tumors~   "
82572|NCT01976585|"~     Our recent trials combining local radiotherapy with intratumoral administration of TLR~     agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma~     demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete~     remissions of patients' non-irradiated sites of disease with complete remissions lasting~     from months to more than three years.~      This iteration of the in situ vaccine approach builds on our prior work in ways that should~     improve its efficacy, by adding Flt3L and changing the toll-like receptors (TLR) agonist to~     poly-ICLC -an optimal TLR agonist for the type of dendritic cells (DC) recruited by Flt3L.~     The vaccine is thus in 3 phases:~        1. intratumoral Flt3L administration recruits DC to the tumor~        2. low-dose radiotherapy to release tumor antigens~        3. intratumoral poly-ICLC administration activates tumor-antigen loaded DC~   "
82573|NCT01976572|"~     The primary objective is to assess the effects of colestilan on the pharmacokinetic profile~     of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours~     after the first daily dose of colestilan administered at doses of 5 g three times daily~     compared to administration of candesartan cilexetil alone, in healthy subjects.~   "
82574|NCT01976559|"~     This research is being done to determine the accuracy of two noninvasive methods of~     measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP).~   "
82575|NCT01976546|"~     Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used~     in the management of difficult airways.~      Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not~     always match with a higher intubation succes. To adress this matter the aim of this study is~     gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape~     intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).~      The hypothesis is that intubation with this combination is easy and can be a good~     alternative when using the McGrath videolaryngoscope in patients with predictors of~     difficult airway.~   "
82576|NCT01976533|"~     This is a historical cohort study with retrospective collection of data comprising all~     Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The~     goal is to determine prognostic factors for mortality and morbidity.~   "
82577|NCT01976520|"~     This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients~     with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing~     an extract of a person's cancer cells and the immunostimulant interleukin-2 may help the~     body to build an effective immune response to kill cancer cells.~   "
82578|NCT01976507|"~     The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic~     event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of~     dabigatran use for peri-procedural anti-coagulation after left atrial catheter~     radiofrequency ablation, or cryoablation procedures.~   "
82579|NCT01976494|"~     Acute post-operative pain causes not only discomfort for the patient, but delays recovery by~     increasing the morbidity of the circulatory system, respiratory system, and immune system,~     so pain control is one of the important objectives in peri-operative patient management.~     Patient controlled analgesia (PCA) is a piece of equipment for which the patient can~     personally control the administration of an analgesic. It is generally used in postoperative~     pain management because it is a method which can heighten patient satisfaction by reducing~     complications and obtaining the appropriate level of pain relief. Usually, it is designed to~     administer an analgesic at a steady speed, and the patient can administer additional~     medication by pressing a button when the pain is severe. Here, to prevent complications from~     excessive administration of an analgesic, repeated administration is not allowed within a~     certain time interval. The PCA equipment can be categorized as electronic and physical~     according to the force which operates the drug injection pump. Electronic equipment uses~     electrical energy to apply vermicular movement to the fluid tube to administer the~     analgesic. Physical equipment is disposable equipment designed to fill an elastomer~     reservoir bag expanding the material, and its elasticity returns to the original length used~     to administer the analgesic. The physical equipment is easy to carry and movement is~     comfortable because there is no need for additional electronic equipment or devices. There~     is also no need for special training to operate the equipment, and the action mechanism is~     simple so there is less opportunity for malfunction. The disposable physical equipment~     accounts for approximately 70% of the domestic market share and it is preferred over the~     electronic equipment. On the other hand, contrary to the electronic equipment, the physical~     PCA equipment has the disadvantage of not providing information regarding the history of the~     equipment's use. The early physical PCA equipment was very simple and only had the function~     of continually administering medication at a set speed. Hence, it was not sufficient to~     function as 'patient controlled' pain control equipment. Then, the function of an additional~     administration button was added so that the patient can personally decide whether to~     administer an additional amount of analgesic. At the same time, the physical PCA equipment~     has improved to prevent excessive administration by setting a lock-out time as a safety~     measure. The following development was Accufuser Selectuss®, where a function was added to~     select the administration speed from three options. In this way, the physical PCA equipment~     has continued to evolve in the direction of enhancing safety, convenience, and clinical~     effectiveness. The advantage of pain control using PCA equipment is that the patient can~     personally control additional the administration of an analgesic by pressing a button. In~     the case of existing or imported products, it is designed to administer a bolus by pressing~     the button, and the pressure presses the PVC bag filled with medication under the button to~     administer the bolus. Compared to the intravenous route, using an epidural as a PCA~     administration route has superior analgesic effect, so it can reduce the amount of opioid~     analgesic administered. On the other hand, the disadvantage is that it has to pass through a~     narrow and long epidural catheter to deliver the medication to the epidural space which has~     a relatively higher resistance. Woo Young Medical experimented with their own product~     Accufuser plus® (Woo Young Medical, Korea), and the results showed that the time taken to~     empty the bolus bag was approximately 40-80 seconds depending on the dosage. The pressure~     when a person presses the bolus button on the PCA equipment was repeatedly measured to~     obtain a mean value, and this pressure was constantly maintained by a machine to measure the~     time taken to empty the bolus bag. Clinically, it is not easy to continually press the~     button for 40-80 seconds, so it is difficult to exclude the possibility that the bolus was~     not administered properly. In addition, when excessive pressure is applied, there is the~     possibility that the bolus bag may burst. The domestically developed products and Accufuser~     Omnibus® (Woo Young Medical, Korea) was developed for the purpose of supplementing bolus~     failure which can occur when using epidural PCA. Within the bolus module, a second~     elastomeric balloon is installed behind the first bolus bag so the patient does not have to~     press the bolus button for a long time.~      Therefore, this research focused on the effectiveness and safety of the domestic product~     Accufuser Omnibus® (Woo Young Medical, Korea) regarding whether the bolus is sufficiently~     delivered when it is administered through the epidural route, and compared the results~     through a comparative clinical trial with imported physical PCA equipment (Infusor SV®,~     Baxter, USA).~   "
82580|NCT01976481|"~     Our study aims to clarify the impact of the use of a standard sunbed according to new EU~     guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan~     to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new~     recommendations for the exposure plan for different skin types according to EN 60335-2-27.~      The use of a sunbed will be compared to a control group not using a sunbed in the~     observation period.~        -  Trial with medical device~   "
82581|NCT01976468|"~     The investigators hypothesize that a low number of SCC in OTR will metastasize.~   "
82582|NCT01976455|"~     The purpose of this study is to develop a novel, non-invasive method that will provide~     personalized feedback during dietary interventions as a marker for compliance.~   "
82583|NCT01976442|"~     The purpose of this study is to determine whether a novel standard of care protocol, washing~     red cell and platelet transfusions for younger patients with acute leukemia, has yielded~     improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This~     standard of care was implemented based upon an earlier randomized trial (BMC Blood~     Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical~     literature.~   "
82584|NCT01976429|"~     This study will determine if newly developed and more standard tests of Eustachian tube~     function can identify those persons who have ear pain (barotrauma) or develop middle-ear~     inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure~     as, for example, during airplane flights or scuba diving. Up to 150 adults and children~     (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop~     middle-ear fluid during those activities and approximately 60 adults and children who fly or~     dive but do not experience these problems will undergo Eustachian tube function testing~     during simulated flight and diving.~   "
82585|NCT01976416|"~     Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute~     painful episodes and reducing the need for blood transfusions in children with sickle cell~     anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan~     Africa, the areas with the most children with SCA.~      The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for~     children with SCA in a malaria endemic region within sub-Saharan Africa.~   "
82586|NCT01976403|"~     The main objective of this randomized controlled trial is to evaluate the effect of an~     intervention formed as a pain booklet provided to patients at discharge from hospital~     following cardiac surgery.~      The primary objectives are to:~        1. Develop and implement a pain booklet to improve pain management after cardiac surgery~        2. Evaluate the effect of the pain booklet compared to a group of patients given usual~          care~   "
82587|NCT01976390|"~     This study is being done to compare the effectiveness and safety of two different kidney~     transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in~     the current standard immunosuppression regimen).~   "
82588|NCT01976377|"~     Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It~     accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is~     the hallmark of most human cancers, including HNSCC, and affects many cellular properties.~     This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.~   "
82589|NCT01976364|"~     This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability~     and efficacy of tofacitinib in subjects with active PsA who have previously participated in~     randomized studies of tofacitinib for this indication.~   "
82592|NCT01976325|"~     BRIEF SUMMARY~      Canadians often visit areas with malaria where the preventative drug chloroquine no longer~     works.~      This leaves Canadians with the choice to use three different drugs to prevent malaria -~     atovaquone-proguanil, doxycycline, or mefloquine. There are more than 400 cases of malaria~     reported in Canada each year, a few which result in death. These cases mainly occur in~     people who do not take malaria pills as directed.~      Investigators have developed the Ottawa Malaria Decision Aid (OMDA), which is a bilingual~     (English and French) resource used to support malaria prevention decision-making. The OMDA~     contains plain language, fact-based information and helps individuals to reflect on their~     own values and beliefs so that they can make the best decision for their situation.~      In this randomized control study, the investigators will attempt to find out if using the~     OMDA before visiting a travel clinic affects decisional conflict and the way pills are~     taken. Consenting travellers will be assigned to standard care or standard care plus the~     malaria decision aid. Both groups will complete three questionnaires before and after travel~     to look at the impact on decisional conflict, preparation for decision-making, decisional~     regret and pill taking behaviour.~      Travelers' malaria can be prevented. It is our hope that by using different methods of~     presenting information, specifically by utilizing the OMDA, there will be an increase in~     adherence to appropriate malaria prophylaxis which will ultimately result in a decrease in~     malaria cases that arrive in Canada. This will translate into a decreased use of health care~     dollars and unnecessary deaths.~      The Objectives of this study are to evaluate whether the malaria decision aid can be~     integrated into the pre-travel consultation process and can:~        -  improve a traveller's knowledge of malaria and prevention strategies;~        -  improve a traveller's preparation for decision-making;~        -  decrease decisional conflict; and~        -  affect levels of adherence to prescribed malaria chemoprophylaxis.~      The hypotheses of this study are that:~        1. A decision aid will improve the quality of decision-making about malaria~          chemoprophylaxis by decreasing decisional conflict and increasing knowledge about~          malaria and malaria pills.~        2. Better decision quality will result in a greater level of adherence to prescribed~          malaria chemoprophylaxis.~   "
82593|NCT01976312|"~     To provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in~     patients with visual impairment due to macular edema secondary to CRVO~   "
82594|NCT01976299|"~     The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the~     kidneys during percutaneous coronary procedures thereby reducing the risk of contrast~     induced nephropathy (CIN).~   "
82595|NCT01976286|"~     The purpose of this study is to find out the safety and effectiveness of Glycolic Acid~     Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.~   "
82596|NCT01976273|"~     The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser~     Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.~   "
82597|NCT01976260|"~     The purpose of this study is to compare the effectiveness of the ePrime fractional~     radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the~     ability to improve acne scar appearance.~   "
82598|NCT01976247|"~     The purpose of this study is to compare the safety and effectiveness of the Zeltiq System~     and LipoSonix System for fat reduction and improving body shape.~   "
82599|NCT01976234|"~     Transfusion of RBC is associated with post operative infections. Our hypothesis is that~     stored blood could be related with increased post operative infection risk. Surgical~     patients transfused during the operation or immediately after will be included in our study.~     Patients will receive fresh or old blood during the whole recovery.~   "
82600|NCT01976221|"~     The primary outcome in this study is more appropriate and comprehensive referrals and a more~     seamless and smoother referral process with reduced workload for both partners. The referral~     rates may be reduced by higher awareness of non-prioritized medical conditions. The use of~     priority setting and waiting time according to the national prioritization guidelines can~     give a higher correlation between GPs and hospital consultants about priority setting and~     waiting time. In this study we will evaluate the effect of a multifaceted educational~     intervention (a training program in priority setting) on the appropriateness and~     comprehensiveness of referrals in terms of the agreement on priority setting and waiting~     time between GPs and hospital consultants.~   "
82601|NCT01976208|"~     The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE~     monoclonal antibody injection in patients with allergic asthma.~   "
82602|NCT01976195|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the~     treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional~     high-dose dexamethasone mono-therapy.~   "
82603|NCT01976182|"~     LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It~     is an indolent disease, the main hematological or autoimmune complications lead to a~     treatment in more than 60% of patients.~      Investigators set up at the University Hospital of Rennes, a database of more than 300~     patients with LGL leukemia from major French services that support this disease, and~     published in 2010 the largest series of patients in the world (n = 229). However, the~     limited heterogeneity and retrospective data collected, as all previously released, makes it~     difficult the proposal of consensual treatment options. If first and second line treatments~     are based on the use of immunosuppression with methotrexate, cyclophosphamide, or~     cyclosporin A, no molecule has proven superiority over others. Methotrexate and~     cyclophosphamide are mainly used in the first line. Invetigators just have in the literature~     data on about 100 patients treated with either of these drugs. Combining the results of our~     series with those in the literature, invetigators estimate the respective overall response~     rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50%~     for cyclophosphamide.~      Thus, there are four objective in this study :~        1. to compare the respective efficacies of methotrexate and cyclophosphamide when~          administered as first-line therapies in patients suffering from T/NK LGL leukemia with~          severe neutropenia or neutropenia associated with infections, and/or anemia requiring~          transfusions, and/or auto-immune associated disease~        2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide~          for which a second line treatment is efficacious~        3. to explore, in case of non-response to the first-line therapy, the efficacy of~          ciclosporine A, the comparison being performed with the treatment which was not~          administered in the first-line therapy~        4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.~   "
82604|NCT01976169|"~     Standard of care:~      Treatment with Trastuzumab~      Experimental:~      21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on~     Days 5-18~      Study Design and Methodology:~      This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with~     T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior~     trastuzumab or other HER2-directed therapies.~      The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes~     on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how~     well the subject tolerates the treatment.~      A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing~     of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days~     5-18 of each 21 day cycle.~      Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral)~     Cohort 3 : PD-0332991 - 200 mg daily (oral)~      The 3+3 design entails that if one patient out of the first three patients has a DLT, up to~     three additional patients will be entered at that dose level~      Treatment cycles will continue until disease progression or withdrawal from study.~   "
82607|NCT01976130|"~     Study hypothesis:~      Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization~     have lower levels of mucins and antimicrobial peptides in their airways~   "
82609|NCT01976104|"~     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group~     study using avatrombopag to treat adults with thrombocytopenia associated with liver~     disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia~     associated with liver disease prior to an elective procedure to reduce the need for platelet~     transfusions or any rescue procedure for bleeding due to procedural and post-procedural~     bleeding complications. Participants will be enrolled into 2 cohorts according to mean~     baseline platelet count and, within each baseline platelet count cohort will be further~     stratified by risk of bleeding associated with the elective procedure (low, moderate, or~     high) and hepatocellular carcinoma (HCC) status (Yes or No).~   "
82610|NCT01976091|"~     Dose escalation study of self-complementary (sc) AAVrh74.tMCK.hSGCA delivered to single leg~     (low dose n=2) and bilaterally (n=6) via a major lower limb artery to the whole lower limb~     of limb girdle muscular dystrophy type 2D (LGMD2D; alpha-sarcoglycan deficient) patients.~   "
82611|NCT01976078|"~     The death rate in children from the invasive fungal infection called aspergillosis is more~     than 50%. Voriconazole is the first-line therapy for this infection. In a previous~     publication the investigators have shown a highly significant relationship between~     voriconazole plasma concentrations and survival. However, voriconazole dosing is currently~     poorly established, and plasma drug exposure varies between children by 400% or more, even~     after intravenous dosing. The objective of this study is to investigate the reasons for this~     variability in voriconazole pharmacokinetics (PK).In two studies, the investigators will~     enroll 80 children/adolescents receiving oral or intravenous voriconazole, divided by age~     under 2 years (n=15), and 2-18 years (n=65). From each patient the investigators will~     collect the following: 1) a blood sample for detection of several genetic changes known to~     affect drug metabolizing enzyme (DME) activity; 2) up to 9 blood samples after a~     voriconazole dose for measurement of voriconazole (PK sampling); 3) follow-up samples~     after each PK sampling visit if necessary to adjust the dose so that voriconazole~     concentrations in the blood are satisfactory (known as therapeutic drug monitoring or TDM).~     At the time of the voriconazole dose prior to the PK sampling, we will also give single IV~     or oral (corresponding to the route of voriconazole administration) low doses of~     esomeprazole (an antacid), midazolam (a sedative), and ranitidine (an antacid) as a cocktail~     to test or probe DME activity. All of these medications are used commonly in children~     already. The investigators will estimate DME activity or phenotype using ratios of probe~     drug metabolite to parent drug concentrations, while simultaneously quantifying the amount~     of DME genetic material (mRNA) and protein in white blood cells. The investigators will test~     associations between DME activity, mRNA, protein, voriconazole PK, age, sex, and degree of~     illness. The investigators will also use a computer program to integrate all these data to~     develop a comprehensive model that will predict blood concentrations of voriconazole in~     children of all ages, as well as assist physicians and pharmacists to dose voriconazole more~     accurately.The total study duration for each subject will be until after the TDM follow up~     visit, generally about one week.~   "
82612|NCT01976065|"~     This multi-center exploratory clinical trial is a randomized trial designed to test whether~     a regenerative endodontic procedure using tissue engineering principles (REGENDO), or a~     revascularization (REVASC) endodontic procedure, in comparison to standard apexification~     treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a~     significantly better composite clinical outcome for the treatment of immature permanent~     teeth with pulpal necrosis.~   "
82613|NCT01976052|"~     Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be~     evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by~     polygraphy.~   "
82614|NCT01976039|"~     Professionals working in polluted areas may present increased clinical airways symptoms and~     dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus~     clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity~     with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The~     aim of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on~     nasal mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms~     in professional motorcyclists.~   "
82615|NCT01976026|"~     The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the~     use of flow diversion, a promising option of yet unproven benefit, in the care of patients~     with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple,~     multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical~     dilemma of whether the use of PED FD truly is a safe and effective alternative to best~     standard treatment, defined as conventional methods of treatment or in some cases,~     observation. Selection criteria are few, to facilitate the recruitment of most affected~     patients confronted with these difficult aneurysms that their physician judges suitable for~     PED FD. The trial does not obstruct clinical care, does not include extra tests or risks~     beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful,~     valuable and resistant to bias. Follow-up visits and tests are routine', imposing no extra~     burden on clinical transactions. Data is collected in simple case-report forms filled by~     physicians.~   "
82616|NCT01976013|"~     Up to now, only data about early and single coagulation screening exist in extreme low birth~     weight infants (ELBW) infants. In neonatal practice, coagulation abnormality in preterm~     babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity,~     which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a~     method to measure PT with small volume samples (10μL) provides the possibility for serial~     monitoring even in ELBW infants (CoaguChek®XS, Roche Diagnostics, Vienna, Austria)).~     Substitution of fesh frozen plasma seemed beneficial in ELBW infants and first trials with~     rFVII revealed promising results in this patient population. Thus, coagulation monitoring~     might lead to early and adequate therapy and therefore to a better outcome. The~     investigators hypothesize that ELBW infants (<1000g birth weight) with primary severe~     prolongation of prothrombin time or development of severe prothrombin prolongation during~     sequential monitoring may have more frequent and more severe bleeding incidents~     (Intraventricular haemorrhage and pulmonary haemorrhage). The investigators aim to explore~     whether monitoring of PT can predict bleeding events in ELBW children.~   "
82628|NCT01975857|"~     The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel~     mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from~     mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health~     Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to,~     the average difference in outcomes between MBB and an active control, sleep education (SED),~     both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed~     project is to introduce, implement and establish mind-body intervention programs as a~     behavioral health intervention modality that would serve as a generally sustainable health~     care intervention program before, during, and after deployment for military personnel.~   "
82617|NCT01976000|"~     Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the~     well-known benefits and comparable oncological outcomes, it is still limited by a lack of~     tactile sensation and a reduced operative field view. In addition, the inconsistency in the~     number and course of the mesenteric vessels significantly influences the learning curve with~     30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy~     can be mapped using CT-angiography, and the images can be processed with rendering software~     to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study~     was to assess the influence of visualizing the three-dimensional vascular anatomy on the~     learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic~     left or right hemicolectomies between January 2012 and January 2014 were evaluated for~     inclusion in this study. To assess the influence of preliminary knowledge of colonic~     vascular anatomy on the learning curve, we considered 2 groups of two surgeons with~     different levels of experience. In the first group (group A), the surgeons were able to view~     3D reconstructions before and during the surgery, while the surgeons in Group B were only~     able to view the 3D reconstructions after surgery.~   "
82618|NCT01975987|"~     This study is designed to identify patients' features predictive of successful intubation~     using the Bonfils fiberscope.~      Our hypothesis is that some patients' characteristics are predictors of successful~     intubation with the Bonfils fiberscope.~   "
82619|NCT01975974|"~     Obtaining peripheral vascular access in medical patients is a necessary procedure for many~     healthcare providers. Peripheral vascular access is traditionally performed using palpation~     or visual inspection to identify appropriate points of entry in the vasculature after which~     a needle and catheter are threaded through the skin and surround fascia into the vessel of~     interest. This procedure, one of the most common procedures in the medical field including~     both artery and vein access, is not 100% successfully attempted. Operator skill heavily~     influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient~     populations have difficult peripheral vessels to identify by palpation or visual inspection~     and past operators would be forced to perform the procedure blind based on anatomical~     landmarks. Recently, to aid vascular identification and increase cannulation success, a~     number of alternative techniques for peripheral vascular access have been described~     including ultrasound-guided.~      Ultrasound-guided vascular access has been utilized in vascular access with improved success~     rate. However, even with ultrasound guidance the first attempt success rate of cannulation~     was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular~     access is most likely due to failure to advance the catheter into the vessel even the vessel~     was successfully punctured. The investigators propose a specific technique and the positive~     Target Sign as a means to obtain almost 100% successful peripheral vascular access.~      The investigators plan to enroll 100 surgical patients in the above study and study~     procedures will not differ from what a patient in the operating room under the care of~     anesthesia faculty would receive. The above study is simply a way to identify the steps~     regarding a specific technique.~   "
82620|NCT01975961|"~     This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and~     rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two~     groups enrolling healthy adult male and female subjects under fasting conditions.~      Subjects will be admitted to the clinic in the evening before Day 1. All subjects will~     receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin~     co-administered in the morning on Day 1. All the subjects will remain in the clinical unit~     until completion of all assessments on Day 2 including collection post-dose PK sample.~     Subjects will return to the clinic for pharmacokinetic samples at scheduled time.~      The two treatment periods will be separated by a washout period.~   "
82621|NCT01975948|"~     The aim of this study is to test the program's effectiveness in a primary care setting in~     reducing stigma among medical personnel, increasing the comfort level of physicians and~     staff in providing care to those living with mental illness, and in improving client~     well-being and mental health.~   "
82622|NCT01975935|"~     This study involves research about an investigational medicine called Amlexanox. The reason~     for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance,~     obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is~     considered to be investigational (not approved by the Food and Drug Administration [FDA])~     for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease~     (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may~     either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or~     the study doctors will know if the patient is receiving the study drug or placebo.~   "
82623|NCT01975922|"~     The goal of the study is to examine the effects of teaching parents to use language support~     strategies on language skills in toddlers with language delays. We hypothesize that children~     whose parents who learn to use language support strategies at home will have greater~     language skills than those children whose parents do not learn the strategies.~   "
82624|NCT01975909|"~     Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive~     problems with gait and balance, as well as other debilitating symptoms. This is a randomized~     controlled pilot study to test a novel therapeutic intervention that uses noninvasive~     magnetic brain stimulation to improve functional outcomes in patients with SCA. The study~     will include quantitative evaluations of gait, balance, and brain physiology to examine~     possible objective end-points for a future, larger multi-site clinical trial. The~     investigators anticipate that patients receiving the real intervention will show a~     functional gain.~   "
82625|NCT01975896|"~     This project will compare the preliminary efficacy of a novel school-delivered intervention,~     mindfulness plus health education intervention, to health education alone on dietary and~     physical activity habits in adolescents. This study has important public health implications~     because of the negative consequences of unhealthy diets and lack of exercise on health, such~     as obesity, cardiovascular disease and diabetes. If effective, this intervention has high~     potential for translation to high school settings~   "
82626|NCT01975883|"~     Analyzing peri operative changes in blood glucose levels from non-diabetic patients~     undergoing spine surgery~   "
82627|NCT01975870|"~     The main objective of the project is to make participants aware of their sedentary behavior~     (prolonged sitting behavior) and then to encourage behavioral change through the use of an~     innovative and fun application on a smartphone.~   "
82631|NCT01975818|"~     Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus~     epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75~     and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be~     based on the subject's Hb response and tolerability of the prior dose. Planned doses include~     15, 25, 50, 75, 100,150 and 200 mg/day~   "
82632|NCT01975805|"~     Currently there are no published studies comparing the efficacy of Chloraprep and~     povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However,~     there have been studies involving other types of surgery that have compared the efficacy of~     different types of preoperative cleansing agents in preventing postoperative wound~     infection. These studies have shown that controversy exists over which antiseptic skin~     preparation is the most effective for preventing postoperative surgical wound infections.~     The standard of care at Los Angeles County Hospital for preoperative skin antiseptic in~     cesarean sections is povidone- iodine 10% (betadine), however many other hospitals have made~     the transition to using Chloraprep. In an attempt to improve on the current standard of~     care, we propose a quality improvement prospective randomized study to compare the~     difference in postoperative wound complications with the use of povidone- iodine and~     Chloraprep as a preoperative antiseptic in cesarean sections. We hypothesize that Chloraprep~     will be better than Betadine at reducing the incidence of positive bacterial cultures~     following cesarean sections.~   "
82633|NCT01975792|"~     The thymus gland is a specialized organ in the chest that plays a central role in the~     adaptive immune system throughout development until puberty. In response to stress, the~     fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort~     study that will enroll pregnant women admitted to labor and delivery for the management of~     preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation.~     Based on sonographic thymus measurements, the investigators will develop a clinical~     prediction tool to identify babies who are at increased risk for adverse neonatal outcomes.~     A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound~     measurements has the potential to affect clinical management, improve outcomes for premature~     babies, and direct further research efforts.~   "
82634|NCT01975779|"~     To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in~     healthy young Japanese men in comparison with Caucasian men.~   "
82635|NCT01975766|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by patients.~   "
82636|NCT01975753|"~     Acute pain relief in emergency setting is still a public health priority. Pain is the~     primary reason for emergency room use, but the situation of oligo-analgesia persists in~     all countries. Intravenous morphine titration has become the standard method for severe~     acute pain management in the emergency department, but it is still insufficiently~     implemented. Deviations from the recommended protocol are common: initial additional loading~     doses, unusually extended intervals between bolus, premature discontinuation. Several~     factors contribute to these difficulties: heaviness of its setting up, especially in~     overcrowding case, procedure rigidity, high consumption of nursing time. This method~     requires a systematic intravenously route, which has several inconvenients: algogenic~     procedures, coupled initial diagnostic venous sampling (delay for analgesia), excessive~     medicalization of ambulatory patients (risk of infection and less mobility in the~     emergency department). An alternative to reduce the analgesic latency in emergency~     department, without losing the benefits of tolerance and safety should be welcome. The~     inhaled route looks promising, but has yet not been enough evaluated in adults, and even~     less in the emergency room. Aerosol techniques change from one study to another (molecules,~     materials, doses, painful intensities included, judgment criteria and assessment times). A~     morphine titration by aerosol therapy could be an interesting alternative to the standard~     method disadvantages, using faster, painless and easier procedures, leading to~     demedicalization.~      To the need for stronger fundamentals, an additional study was designed in healthy~     volunteers. The objective is to compare the titration of intravenous morphine titration~     aerosol in moderate acute pain caused by electrostimulation.~      To purchase this aim, we first need to determine accurately the smallest dose of effective~     and well tolerated inhaled morphine, to provide the bolus dose we have to repeat by~     titration, which is still currently unknown. This dose is called ED50, it's the effective~     dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also~     needed to be established, unknown in this indication. The determination of these two~     parallel ED50 would allow a reliable conversion factor between the two routes of~     administration for morphine bolus, which can then be tested in comparative titrations. To~     validate our induced pain model in healthy volunteers, we also have chosen to fix in these~     conditions the ED50 of fentanyl that the effective dose by nebulization is better known.~     This study would also describe the pharmacokinetics of inhaled morphine and its derivatives~     after a single spray.~   "
82637|NCT01975740|"~     Question: Does manual diaphragm release change kinematics and respiratory function of~     elderly subjects? Design: Randomized controlled trial with concealed allocation and~     double-blinding.~      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control~     Group (CG) and 08 in the Intervention Group (IG).~      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten~     deep breaths, with a one minute interval between them. The CG underwent a sham protocol~     (light touch), with same sets and time of interval.~      Outcome measures: The groups were evaluated using spirometry, manovacuometry and~     optoelectronic plethysmography (OEP), in that order, before and immediately after the~     intervention.~   "
82638|NCT01975727|"~     Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia.~     Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about~     the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single~     randomised trial has been published so far that tests the efficacy of dexamethasone for the~     treatment of established PONV symptoms. In this trial the investigators want to test the~     antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment~     of established PONV symptoms. In adjunct protocols of this study the investigators aim to~     establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to~     study pharmacogenetics of PONV, and to further our understanding on the smoking status as a~     predictive factor of PONV.~   "
82652|NCT01975545|"~     Patients with trisomy 21 are in greater danger of developing caries. It has been~     hypothesized that adding silver nanoparticles to fluor varnishes could promote~     remineralization of the teeth. A split-plot randomized controlled trial will be performed to~     address this question.~   "
82653|NCT01975532|"~     The purpose of this study is to explore the relationship between deep brain stimulation~     implantation site and DTI (diffusion tensor imaging) derived measures for the region and~     later compare this to the clinical treatment outcomes.~   "
82892|NCT01972399|"~     The primary objective of this study is to compare the clinical outcomes of using Er: YAG~     laser along with bone graft and barrier membrane to conventional mechanical debridement also~     with bone graft and barrier membrane in the treatment of peri-implantitis infections.~   "
82639|NCT01975714|"~     Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product~     composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation.~     This new product is used as a once-daily topical ocular therapy for the reduction of~     elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular~     hypertension, and that are sensitive to preservatives. The individual active component of~     BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy~     (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing~     uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF,~     eg. Monoprost®), was recently launched in a number of countries in Europe and contains~     latanoprost in a new preservative free formulation.~      It is clinically important to compare these newly entered preservative free products with~     respect to tolerability and efficacy. A better tolerability combined with maximum efficacy~     will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to~     the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.~      The hypothesis of the study is that monodose bimatoprost is more effective than monodose~     latanoprost by at least 1 mmHg.~      (AIBILI applied for an unrestricted grant from Allergan to perform this study)~   "
82640|NCT01975701|"~     This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to~     adult patients with histologically confirmed GBM and/or other glioma subtypes with~     FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.~   "
82641|NCT01975688|"~     To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics~     [PKs] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol~     [CBD]) when mild, moderate or severe oral mucositis is induced. This will be done by looking~     at the effects of the body on the drug before and after oral mucositis is induced. The study~     participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral~     mucositis will be induced with radiotherapy and/or chemotherapy.~   "
82642|NCT01975675|"~     This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)~     fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or~     treatment-experienced Japanese participants with chronic genotype 1 HCV infection.~     Participants receive 12 weeks of treatment and continue assessments during a 24-week~     posttreatment follow-up period.~   "
82643|NCT01975662|"~     The aim of this study is to compare the efficacy of daptomycin treatment versus vancomycin~     treatment in the treatment of methicillin resistant staphylococcus aureus (MRSA) bloodstream~     infections (BSI) due to isolates with high vancomycin minimum inhibitory concentrations~     (MIC) (i.e. > or equal to 1.5 ug/ml) in terms of reducing all-cause mortality.~      Our secondary aim is to compare clinical failure rates of daptomycin treatment versus~     vancomycin treatment and to compare time to microbiological clearance in patients treated~     with daptomycin versus those treated with vancomycin.~      Our primary hypothesis is that Daptomycin treatment is superior to vancomycin treatment in~     reducing mortality from BSIs due to MRSA with high vancomycin MIC from 25% to 10%.~   "
82644|NCT01975649|"~     Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a~     reduction in circulating androgen levels. The aim of this study is to evaluate the effects~     of Tribulus Terrestris in premenopausal women with HSDD.~   "
82645|NCT01975636|"~     This is an open-label, single dose study in healthy male subjects.~   "
82646|NCT01975623|"~     VATS anatomical lung resection provides an effective minimally invasive treatment strategy~     for stage I and II lung cancer. VATS lobectomy is associated with significantly less~     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications~     when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. The technical difficulty and~     increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation~     and this is the main limitation for many thoracic surgeons regarding the adoption of VATS~     lobectomy into their practise. Furthermore, the majority of VATS lobectomies are being~     performed in high volume, academic medical centers with a resultant disparity in~     socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a~     way to decrease the manipulation required by the surgeon on the PA branches, these~     procedures will be safer, less stressful for the surgeon and therefore more prevalent for~     anatomical pulmonary resections.~   "
82647|NCT01975610|"~     CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid~     arthritis an autoimmune inflammatory disorder.~      This study will test the clinical effectiveness and safety of an orally (PO) administered~     dose of CC-292 compared to placebo in US female patients currently on background~     Methotrexate (MTX) with active Rheumatoid Arthritis (RA~   "
82648|NCT01975597|"~     This is a feasibility study to demonstrate the team's ability to collect bone marrow~     aspirates and biopsies for research purposes from women with metastatic breast cancer.~   "
82649|NCT01975584|"~     This is a pilot study. We are testing the physiologic, immune and chemical responses to~     stress. We believe the results of all measures to stress will be blunted in schizophrenia~     compared to healthy controls. We will test sex, early life stress and other factors on the~     relationship to a stress response.~   "
82650|NCT01975571|"~     The purpose of this study is to determine if adults and children with residual low-pitch~     hearing in the severe hearing loss range can develop improved speech perception by combining~     their residual acoustic hearing with electrical stimulation through a short cochlear~     implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds~     would be stimulated electrically.~   "
82651|NCT01975558|"~     Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic~     profile in the exposed area and/or systemically and specific radiation biomarkers can be~     identified in the respective matrices.~      Purpose: This is a pilot study to verify in humans the results obtained from two animal~     models exposed to ionizing gamma-radiation. The classification of patients results from the~     treatment volume of radiotherapy for cancer disease. Two patient groups with different types~     of cancer (breast cancer and endometrial cancer) undergoing high-dose radiotherapy are~     selected and compared to control group of age matched healthy women.~   "
82654|NCT01975519|"~     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a~     recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with~     advanced soft tissue sarcoma. Up to 18 patients will be treated.~      The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft~     tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with~     angiosarcoma by RECIST 1.1. Up to 76 patients will be treated in phase 2, including a cohort~     of up to 13 patients with angiosarcoma.~   "
82655|NCT01975506|"~     The purpose of this study is to identify the role of occupational therapy within Head Start~     programs. Representatives within Head Start will be asked to participate in a nationwide~     internet based survey identifying the amount and type of services provided within this area.~     The Model of Human Occupation (MOHO) will also be included in the study by identifying~     current use of the model and how it can be utilized in the future. In order to complete this~     study to the fullest extent, we must begin by defining the Model of Human Occupation as well~     as understanding the mission of the National Head Start Association. The vision of MOHO is~     to support practice that is focused on occupation, client centered, holistic,~     evidence-based, and complementary to other occupational therapy models. The mission of the~     National Head Start Association is to coalesce, inspire and support the Head Start field as~     a leader in early childhood development and education. This has lead researchers to perform~     the following study: An examination of occupational therapy in the context of Head Start.~   "
82656|NCT01975493|"~     The aim of NAPPA is to develop new models to improve our understanding of how children~     process ('metabolise') penicillins, to help us discover if we can improve the dosing~     regimens used for children in the future. The study population will involve children and~     neonates who need a penicillin antibiotic as part of their normal National Health Service~     (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic~     study can be done without the need for any extra invasive procedures, and there will be no~     change to the medication therapy received by participants. In addition, NAPPA will evaluate~     whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto~     absorbent paper (dried blood spot). This allows the sample to be stored and tested later~     on. NAPPA will compare the level of the antibiotic using this method with the level measured~     in the usual way, to show if this is a reliable method that could be used routinely in the~     future.~   "
82657|NCT01975480|"~     This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and~     tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized~     Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary~     trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to~     100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial~     objective is to determine whether or not treatment outcome in GAD is related to changes in~     cortical prefrontal activity of norepinephrine.~   "
82658|NCT01975467|"~     The objective of this post-market clinical study is to compare one to three year post~     treatment results, range of motion, strength, patient related functional outcomes and~     patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as~     compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle~     fractures.~   "
82659|NCT01975454|"~     Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies~     have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will~     evaluate the safety and efficacy of TLBZT based herbal therapy in combination with~     chemotherapy in patients with metastatic colorectal cancer.~   "
82660|NCT01975441|"~     This study will determine if a combination of 3 drugs used to treat the infection that cause~     lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in~     killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given~     to treat this infection. The three drugs used together are called albendazole (ALB),~     ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG)~     for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been~     previously used to treat LF.~   "
82661|NCT01975428|"~     People with chronic diseases such as diabetes, hypertension (high blood pressure) and~     cardiac (heart) arrhythmias tend to go to the doctor more often and have more tests done~     than those without those diseases. This can lead to increasing costs of healthcare and extra~     visits to doctors and healthcare facilities.~      There are now medical devices that can be used at home to monitor blood sugar, blood~     pressure, heart rhythms as well as other measurements. There have been some studies which~     show that when people take their own health readings, they are better able to control their~     disease, stay healthier and go to the doctor less often. In order to participate in the~     study participants will have been diagnosed with 1 or more of the following: Diabetes,~     Hypertension, Cardiac Arrhythmias.~      This study is designed to test those devices and see if they can help participants stay~     healthier through the recording and tracking of health measurements. Investigators will also~     be testing how easy it is to use these devices and whether or how easy it is to fit them in~     their daily schedule. Participants will be given an iPhone for use during the study and~     their recordings will be stored and displayed on the phone.~   "
82662|NCT01975415|"~     This study will investigate the acute response to meditation during a week-long meditation~     retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of~     numerous biometric parameters in selected cohorts of experienced and novice meditators~     during periods of meditation and specific breathing techniques. Comparisons between cohorts~     as well as over time will allow for the identification of meditation and/or~     breathing-related changes.~   "
82663|NCT01975402|"~     We will evaluate the end to end remote monitoring system in a less controlled environment~     and concurrently develop the infrastructure to support the back end of the system~   "
82664|NCT01975389|"~     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to~     placebo, in reducing the occurrrence of major cardiovascular events, including~     cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent~     revascularization in high risk subjects who are receiving background lipid lowering therapy~     and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C~     >/=130 mg/dL (3.4 mmol/L).~   "
82893|NCT01972386|"~     To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of~     lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.~   "
82665|NCT01975376|"~     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to~     placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular~     death, myocardial infarction, stroke, and unstable angina requiring urgent~     revascularization, in high risk subjects who are receiving background lipid lowering therapy~     and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/=~     100 mg /dL (2.6 mmol/L).~   "
82666|NCT01975363|"~     This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in~     reducing inflammatory changes in breast tissue in obese women at high risk for breast~     cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk~     of developing breast cancer.~   "
82667|NCT01975350|"~     There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium~     inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.~   "
82668|NCT01975337|"~     The primary objective of the study was to compare the single dose pharmacokinetics of~     alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of~     matched healthy subjects. The secondary objective was to evaluate the safety and~     tolerability of a single dose of alisporivir when administered to subjects with ESRD.~   "
82669|NCT01975324|"~     Determine whether dalfampridine (Ampyra) can improve visual function in patients who have~     had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.~   "
82670|NCT01975311|"~     The purpose of this study is to determine if a lower back treatment would change the knee~     pain intensity and the level of functional activities as well as the muscle activities in~     people with anterior knee pain. The investigators hypothesized that the lower back treatment~     may change the hip and knee muscle activities as well as reduce the knee pain intensity and~     improve the functional activities in people with anterior knee pain.~   "
82671|NCT01975298|"~     The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of~     laquinimod compared to Avonex®~   "
82672|NCT01975285|"~     The purpose of this research study to evaluate the effects of dexamethasone as an addition~     to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on~     length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain~     scores, and patient satisfaction after foot and ankle procedures.~   "
82673|NCT01975272|"~     The purpose of this study is to determine whether oral or intravenous iron is effective in~     the treatment of anaemia (iron-poor blood) after gynaecologic surgery.~   "
82674|NCT01975259|"~     Most Cystic fibrosis (CF) patients now commonly live well into adulthood, this means they~     are progressively accumulating damage to the insulin-secreting cells inside their pancreas.~     This explains why most adult patients have some degree of abnormal sugar regulation & rates~     of diabetes rise significantly with age. CF related diabetes is categorically different from~     other types of diabetes & its development is serious as it heralds a faster decline in lung~     function & a reduced life expectancy.~      The hallmark of abnormal sugar handling in CF is high glucose levels after meals as the~     damaged pancreas responds abnormally slowly. Over 70% of the initial response of a healthy~     pancreas is induced, not by glucose alone, but by hormones released from the bowel known as~     incretins. We want to establish whether incretins are important in blood sugar handling in~     CF as specific drugs that enhance their effect are now available.~      The study hypothesis is that the incretin system will function normally in patients with~     Cystic Fibrosis. To show this we will measure how much insulin secretion is dependant on~     incretin hormones in CF patients by comparing levels after a sugary drink test and then an~     intravenous glucose drip test (run at a rate that mimics the blood sugar levels obtained~     during the first test to make it a fair comparison ) - as incretins will only be produced in~     the first test when the sugar passes through the bowel any extra insulin produced will be~     due to these hormones. To detect resistance to the incretin hormones we will separately~     measure responses to direct infusions of the hormones themselves. We will explore which~     components of meals cause incretin hormone release from the bowel wall by measuring blood~     levels after different types of meals are consumed. Finally we will measure levels of the~     enzyme that breaks down the incretin hormones (DPP-4) to know if they are deactivated more~     quickly in people with CF. By describing the incretin system in CF we will considerably~     improve our understanding of this important condition as well as potentially highlighting~     new ways to treat it.~   "
82675|NCT01975246|"~     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group~     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg~     +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+~     amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the~     double-blind period in essential hypertensive patients who fail to respond adequately to~     telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a~     6-week open-label run-in period taking T80/A5 mg.~   "
82676|NCT01975233|"~     An observational post-market, open label, multicenter Observatory. The decision to use a WEB~     device to treat the patients has been made before and independently of the decision to~     include the patient in the French Observatory.~   "
82677|NCT01975220|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly~     developed fixed dose combination (FDC) tablets containing empagliflozin & metformin and the~     single tablets of empagliflozin and metformin when administered singularly.~   "
82678|NCT01975207|"~     To determine if treatment of significant depressive symptoms identified in individuals~     attending a family practice improves either psychiatric outcome, overall health care costs,~     or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based~     approach and a comprehensive depression pathway - will be compared to two control groups~     (those who have treatment as usual after screening for depression and measurement of QOL,~     and a second control group who will have QOL data only collected). The investigators hope to~     help Alberta Health Services identify which approach is best as rapidly as possible so that~     the best approach can be implemented throughout the province of Alberta.~   "
82679|NCT01975194|"~     This study will assess the rate at which rosuvastatin will achieve LDL targets in African~     American patients with previous history of stroke or TIA.~   "
82680|NCT01975181|"~     The Cardiovascular Health Program (CHP) Registry seeks to improve the cardiovascular disease~     (CVD) risk profile of subjects through therapeutic lifestyle change using an integrative~     model of medicine.~   "
82722|NCT01974622|"~     The purpose of this research is to use an approved drug(Visudyne) for neovascular~     age-related macular degeneration, which is essentially choroidal neovascularization for~     permeability and vascular proliferation for the retinal circulation, to treat another~     permeable abnormality - retinal capillary abnormalities - located eccentric to the central~     portion of the macula or in the foveal region.~   "
82681|NCT01975168|"~     A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged~     above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2~     groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2~     receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of~     washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser~     acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide~     Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds~     every time, 3 times per week. The measurements of outcomes are performed in the beginning,~     weekly during treatment, and monthly after treatment for 3 months.~   "
82682|NCT01975155|"~     Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten~     free diet is the only available therapy but few is known about its nutrient content and~     mycotoxin exposure.~   "
82683|NCT01975142|"~     Patients with metastatic breast cancer considered HER2 negative are screened for~     HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is~     detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II~     with an adaptive design.~   "
82684|NCT01975129|"~     This study aims to evaluate the uptake of oxytocin following intravaginal administration of~     Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after~     vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to~     70 years old with vaginal atrophy will be included and will self-administer Vagitocin~     intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a~     single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels~     after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at~     timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours,~     relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic~     variables will be calculated. The % of oxytocin which was absorbed following vaginal~     administration (bioavailability)will also be calculated.~   "
82685|NCT01975116|"~     This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating~     peptide p28 (p28) in treating patients with recurrent or progressive central nervous system~     tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
82686|NCT01975103|"~     This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to~     diabetic macular edema, chronic central serous retinopathy, macular edema secondary to~     branch retinal vein occlusion and macular telangiectasia.~   "
82687|NCT01975090|"~     The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide~     temporary protection against pulmonary embolism (PE).~   "
82688|NCT01975077|"~     Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison~     MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1,~     2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor~     xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and~     efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these~     2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and~     regimen in phase II/III study.~   "
82689|NCT01975064|"~     The purpose of this study is to determine whether anesthesia maintained with propofol~     results in better one- and five-year-survival than anesthesia maintained with sevoflurane.~   "
82690|NCT01975051|"~     We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL;~     anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its~     pathogenesis & PKDL patients are genetically predisposed; diagnostic tool based on~     immunofluorescence technique will be more sensitive than slit skin examination for diagnosis~     of PKDL.~   "
82691|NCT01975038|"~     Determining Fitzpatrick skin phototypes (FST) allows physicians to assess a person's risk of~     developing sunburn, and thus the need for sun protection to prevent the development of skin~     cancer. Reflectance spectrophotometry objectively measures the melanin index (MI) and can~     assist in determining the accuracy of self-reported FST compared with~     dermatologist-determined FST. At present, we seek to determine the accuracy of an adapted~     Skin Sun Sensitivity Scale for individuals of all pigmentation varieties (FST I through VI)~     as compared with spectrophotometric measurements assessing FST. Our principal objective is~     to correlate the MI under usual conditions by spectrophotometry with the adapted Fitzpatrick~     SPT as determined by the patients' responses to the adapted questionnaire.~   "
82692|NCT01975025|"~     The aim of this clinical research project is to test the hypothesis that daily dialysis has~     favorable effects on the calcification propensity of human serum, when determined by the~     investigators' newly developed in vitro serum test. The investigators' hypothesis is that~     shorter interdialytic intervals will result in an improved calcification propensity of~     serum. The determination of serum calcification has the potential to become a novel measure~     of dialysis quality in the future.~   "
82693|NCT01975012|"~     Development of tolerable and effective antiretroviral (ARV) drugs for use in children and~     adolescents remains a high priority. First-line therapy with non-nucleoside reverse~     transcriptase inhibitors (NNRTIs) has proven to be effective for HIV-1-infected infants,~     children, and adolescents. This study will evaluate the safety, effectiveness, and dosing~     levels of the NNRTI rilpivirine (RPV) when given with two other ARV drugs in~     treatment-naive, HIV-1-infected children less than 12 years of age.~   "
82694|NCT01974999|"~     This study is a multicenter, non-randomized, retrospective study to collect long term (5~     years post-transplant) clinical outcome data to test whether the results of the noninvasive~     immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in~     first six-month post-transplant is predictive of 5-year outcomes. Each center will complete~     a retrospective chart review for the data on patient survival, graft survival and renal~     function.~   "
82747|NCT01974297|"~     The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg~     with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals~     with atorvastatin 10mg monotherapy.~   "
82748|NCT01974284|"~     We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid~     cancer.~   "
82695|NCT01974986|"~     Athletes participating in multiple training sessions a day can be at increased risk of~     suboptimal hydration and heat illness during their second training session, especially when~     the environment is hot and humid. With the exception of the absolute volume of water~     delivered by a rehydration beverage, characteristics of the beverage consumed play a role in~     the recovery and completeness of rehydration. The amount of sodium in the beverage has been~     shown to be a primary factor in rehydration. Recently, an effect of the carbohydrate~     concentration of the beverage was been reported, with its effects mediated by the renal~     system in response to elevated serum insulin. The purpose of this study is to compare sodium~     and carbohydrate effects on rehydration and recovery.~   "
82696|NCT01974973|"~     The purpose of this study was to study the effect of stem cell therapy on common symptoms in~     patients with autism spectrum disorders~   "
82697|NCT01974947|"~     Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who~     conduct their sperm test through their diagnosis of infertility~   "
82698|NCT01974934|"~     To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression.~     Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change~     in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression~     Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment~     and analysis of change between baseline and 12-week scores.~      To evaluate the effectiveness of desvenlafaxine as a first-line treatment for vascular~     depression in a sub-group of patients who have experienced a TIA greater than 6 weeks prior~     to baseline. Mean differences between baseline and 12-week efficacy measures will be~     examined within the sub-group.~   "
82699|NCT01974921|"~     The purpose of this study is to evaluate clinical and histological response to bronchial~     thermoplasty in severe asthma patients.~   "
82700|NCT01974908|"~     This study involves recording electrical signals inside the heart during an ablation~     procedure. It is thought that by studying these electrical signals in detail the~     investigators may be able to better identify and treat patients at risk of Ventricular~     Tachycardia (VT).~      VT is where the lower chambers (ventricles) of your heart beat fast and this condition can~     be life-threatening. An ablation procedure is performed in patients who have VT despite the~     best treatment available with tablets.~      Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by~     applying a type of electrical energy through a catheter. An important part of the ablation~     procedure is the identification of the exact part of the heart muscle responsible for~     causing the VT. This typically involves sampling the electrical signals in lots of different~     areas of the heart, which allows the construction of computer generated 3 dimensional~     pictures of the structure and the electrical circuits inside the ventricle. Recent research~     has identified a new method to interpret these electrical signals (called Fibrillatory~     Factor - FF), which may allow better identification of the area within the ventricle that~     should be ablated.~      A standard VT ablation will often involve us controlling the heart-beat by pacing the heart~     through 1 of the investigators catheters within the heart. The electrical response to pacing~     at different heart rates can often provide your doctor with information to help the~     ablation. This study will involve an additional period of pacing at different heart rates,~     during which the electrical response is measured in different areas around the ventricle.~     This will allow us to calculate areas of the ventricle, which the investigators new measure~     FF would predict to be the source of the VT. In the future this may then allow us to better~     identify patients who are at risk of VT, and to better locate the area that needs to be~     ablated.~   "
82701|NCT01974895|"~     The purpose of this study is to evaluate the immunogenicity and safety of the new influenza~     vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)~     in children 6 to 35 months of age.~   "
82702|NCT01974882|"~     Postoperative pain is an unavoidable consequence of open abdominal surgery. Although~     cryotherapy, the application of ice to a surgical wound site, has been shown to be effective~     in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not~     been assessed in patients who undergo major open abdominal operations. We hypothesized that~     patients who receive cryotherapy would report lower pain scores as a primary outcome~     measure. This would result in less narcotic analgesia usage, and shorter hospital stays as~     secondary outcome measures.~   "
82703|NCT01974869|"~     Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor~     Necrosis Factor-α agents are antibodies directed against a key cytokine in the process~     angiogenesis and collagen synthesis. It is not known whether they intervene with surgical~     stress response increasing the rate of postoperative complications.~      Method: Un-blinded prospective, non-interventional cohort single centre study including all~     the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery.~     Immunological and endocrinological parameters will measured in blood samples taken from~     these patients before and after surgery. Power calculations showed that 17 patients in each~     arm are needed.~   "
82704|NCT01974856|"~     The primary objective of this study is to assess the extent to which the Prosigna™ Breast~     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment~     recommendations regarding adjuvant chemotherapy and actual treatments received for patients~     with early-stage breast cancer.~   "
82705|NCT01974843|"~     Caudal block is the regional anesthetic technique that is used most frequently in pediatric~     surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of~     analgesia but ideal combination were not found that has minimal adverse effect. The aim of~     this study was to compare the postoperative analgesic efficacy of equal concentrations of~     bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing~     minor urological surgery.~   "
82706|NCT01974830|"~     This is a longitudinal, observational, non-interventional registry study, designed to~     collect both retrospective and prospective real world data, on patients receiving Alpha-1~     augmentation therapy in the home through Coram Specialty Infusion.The data will be collected~     from standard Coram homecare forms, as well as patient reported case forms.~   "
82707|NCT01974817|"~     The purpose of the study is to determine the response of 13-valent conjugate pneumococcal~     vaccine in patients 50 years or older with end stage renal disease on dialysis.~      The study will also try to determine Streptococcus pneumoniae colonization in patients 50~     years or older with end stage renal disease on dialysis.~   "
82708|NCT01974804|"~     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the~     body using magnetic field and radio frequency pulses that can not be felt. The purpose of~     this study is to determine if new imaging methods can help tumor evaluation in the brain.~     The extra images will be obtained using diffusion and perfusion MRI techniques to assess~     early treatment response in patients with brain metastasis, and will be compared to methods~     currently being used.~   "
82749|NCT01974271|"~     This prospective, multicenter, observational study will evaluate the impact of comorbidities~     on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera~     (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months~     of treatment.~   "
82709|NCT01974791|"~     The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure~     Treatment (GET Living) to target elevated pain-related fears in children with chronic pain.~     Pain-related fear is an important psychological factor associated with poor outcomes in~     children suffering with chronic pain. To examine the efficacy of GET Living in addressing~     pain-related fears the investigators propose to use a sequential replicated randomized~     single-case experimental phase design with multiple measures. The specific aims are to 1)~     evaluate the effectiveness and acceptability of individually tailored GET Living for~     children with high pain-related fear and functional disability and 2) define anatomical and~     resting state connectivity patterns in the brains of children and adolescents with complex~     chronic pain prior to and after participation in GET Living.~   "
82710|NCT01974778|"~     Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and~     human babies that is capable of extremely high rates of energy burning. We now know that in~     adult humans it is present and also able to burn energy.~      In addition to increased energy expenditure during cold exposure, energy burning is also~     increased after consuming a meal. Animal studies have shown that part of this additional~     energy consumption is contributed by BAT. In the present study we will aim to examine~     whether BAT activity is increased after a meal.~   "
82711|NCT01974765|"~     This is a Phase II study. The purpose of this study is to find out what effects, good and/or~     bad enzalutamide has on the patient and the cancer. All patients who enter the study will be~     closely monitored for side-effects. If multiple patients develop significant side effects~     from enzalutamide, the study may be stopped early.~      Enzalutamide is an androgen-receptor inhibitor, which means that it blocks the activity of~     the hormone testosterone. In ovarian, fallopian tube, and primary peritoneal cancers that~     express the androgen receptor, blocking the androgen-receptor may possibly slow or stop~     tumor growth. Enzalutamide has been studied in women with breast cancer, but this is the~     first study using enzalutamide for the treatment of patients with ovarian, primary~     peritoneal, or fallopian tube cancer.~   "
82712|NCT01974752|"~     Selumetinib therapy in patients with metastatic uveal melanoma.~   "
82713|NCT01974739|"~     Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce~     hypernatremia and shorten the time of hypernatremia, we investigate the effect of~     hydrochloorthiazide compared to a placebo~   "
82714|NCT01974726|"~     The aim of this study is to determine which of the many Eustachian tube function tests (or~     combination of tests) is most helpful in finding out what is causing ear problems in~     children and adult patients with middle-ear diseases thought to be due to poor Eustachian~     tube function. The Eustachian tube is a biological tube that connects the middle ear to the~     back of the nose and throat. When the Eustachian tube works normally, it opens and closes to~     help keep the pressure in the middle ear the same as room air-pressure (atmospheric~     pressure). When the Eustachian tube does not work well, the pressure in the middle ear can~     increase or decrease and feel like a blocked ear or cause ear pain. Poor Eustachian tube~     function can be associated with distressing middle-ear symptoms, predispose to middle-ear~     problems under conditions of rapidly changing air pressures such as occur during airflight~     and diving, and cause certain middle-ear diseases such as otitis media with effusion. It is~     also known that the results for the most commonly used Eustachian tube function tests in~     adults and children with various middle-ear diseases are poorer when compared to children~     and adults without middle-ear diseases. However, knowing that there is a difference in test~     results between groups with and without disease does not mean that any of those tests~     provide information useful in the management of individual patients with diseases due to~     Eustachian tube function. To be useful clinically, a test(s) that can accurately identify~     patients with a level of poor Eustachian tube function sufficient to cause middle-ear~     symptoms and signs and/or cause middle-ear disease is needed. To be very useful, tests~     should be able to diagnose the cause of any observed Eustachian tube problem so that~     treatment for that problem could be begun. The investigators would also want tests that~     could predict whether or not the ear disease will resolve with (or without) treatment and~     whether or not certain surgical procedures for middle-ear problems will be successful. Here,~     a number of Eustachian tube function tests are being used to diagnose and characterize the~     cause of Eustachian tube dysfunction in children and adults presenting to the research~     clinic with suspected poor Eustachian tube function and/or a recent history of middle-ear~     disease that can be caused by poor Eustachian tube function. After the testing, medical~     records will be periodically reviewed for 2 years and study participants will be contacted~     by phone to obtain information on their middle-ear disease, the response of the disease to~     any treatments and the success/failure of any surgical procedures used to fix middle-ear~     problems.~      Because this study focuses on evaluating the potential usefulness of Eustachian tube~     function testing for the diagnosis of Eustachian tube dysfunction and, if present, its~     cause, no specific treatments or surgical interventions are included in this study or~     recommended by the investigators. These decisions are left to the subject-patient in~     consultation with their doctor.~      To further evaluate the Eustachian function tests, a control group of healthy adults without~     a history of middle-ear problems will undergo testing at two separate sessions; these~     subjects will have no further follow-up.~   "
82715|NCT01974713|"~     Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in~     Ontario. The goal is to determine whether and how rates of renal disease progression are~     affected by inflammatory markers, FGF23 levels, and genetic polymorphisms~   "
82716|NCT01974700|"~     Seizures are a potential complication of surgical repair of intracranial aneurysms. In order~     to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during~     the intra-operative and post-operative period, however, such practice is not supported by~     clinical data. Retrospective review found the incidence of postoperative seizures was higher~     in those who received anti-epileptics versus those who did not. The goal is to examine the~     utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical~     repair of unruptured intracranial aneurysms.~   "
82717|NCT01974687|"~     This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK)~     of MK-3682 (IDX21437) in healthy participants and in participants infected with HCV genotype~     (GT)1-GT6. The effect of food on the PK of MK-3682 will be evaluated. The antiviral activity~     of MK-3682 will also be assessed in HCV-infected participants.~   "
82718|NCT01974674|"~     It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the~     allogeneic islet transplantation for the treatment of type 1 diabetes.~      19 patients with type 1 diabetes will be included and ideally distributed evenly: patients~     with unstable diabetes without renal insufficiency (AI group for islet alone by the~     international customary determination) and patients with a functioning kidney transplant~     (IAK group for islet after kidney). The main endpoint will be defined by the restoration~     of normal glycemic control without insulin at 6 months after graft.~   "
82719|NCT01974661|"~     The primary objective of this study is to answer the question Is it possible to inject the~     COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects?~   "
82720|NCT01974648|"~     The aims of this study were to determine the clinically required concentration of propofol~     for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of~     propofol and improves conditions for it's insertion.~   "
82721|NCT01974635|"~     In this study, an FDA-cleared device and type of treatment called AMES, which stands for~     Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in~     the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury,~     or stroke improves along with movement through treatment. We hypothesize that measureable~     improvement in the sensation of the upper limb will precede improvement in functional~     movement.~   "
82723|NCT01974609|"~     The purposes of this noninferiority randomized clinical trial are to:~        1. determine whether the most commonly used commonly used non-narcotic analgesic~          (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably~          worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5~          mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal~          tunnel release.~        2. Determine whether the following covariates affect pain level following surgery or~          medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site,~          workers compensation status and employment status~          (employed/self-employed/unemployed-able to work/unemployed-unable to work)~   "
82724|NCT01974596|"~     The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri~     Prodentis upon the peri-implant health of edentulous patients with dental implants and~     peri-implant mucositis, establishing comparisons versus implants without peri-implant~     disease. The hypothesis of the study is that using these probiotics are going to improve the~     periimplant health.~   "
82725|NCT01974583|"~     Split-thickness skin grafting remains fundamental treatment of patients with deep burns and~     other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing~     has been controversial until now. Our study here aimed to assess patient comfort and~     wound-healing efficacy with the application of thin split-thickness grafting on STSG donor~     sites.~   "
82726|NCT01974570|"~     Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases.~     Epidemiological studies show that there is a direct relationship between blood pressure and~     CVD, and cardiovascular mortality increases progressively throughout the range of blood~     pressure, including the prehypertensive range. There is also evidence from cell and animal~     studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other~     marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide~     concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.~   "
82727|NCT01974557|"~     Primary: To observe how hemodynamic parameters are affected by age during rest and exercise~     in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.~      Secondary: To thoroughly examine this population with regard to cardiac performance and~     function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary~     status, and humoral markers of organ functions. This population will serve as a healthy~     control group, to which different populations can be compared, hence the need for a~     comprehensive characterization.~      Hypotheses:~      Diastolic function and parameters associated with diastolic function gradually deteriorate~     with increasing age. The gradual deterioration is unmasked at an earlier age during exercise~     and fluid challenge, compared to measurements made at rest.~   "
82728|NCT01974544|"~     The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis~     for the 21st century. Currently, it is estimated that there are 205 million people with T2DM~     worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes~     increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by~     hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the~     treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly~     reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM~     achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric~     surgery has emerged as an effective treatment for T2DM. Data from different sources has~     shown that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently,~     Sleeve Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged~     as an attractive T2DM-controlling bariatric procedure with fewer complications than RYGB.~     Recently, the International Federation for Diabetes has supported the use gastrointestinal~     surgery initially developed for morbid obesity as an option to treat patients with diabetes.~     In the current proposal the investigators aim to address several issues concerning metabolic~     surgery and the ability of the most common bariatric procedures performed to control~     diabetes. The investigators are proposing a prospective randomized trial comparing RYGB, SG~     and the best medical treatment availed for the T2DM in poorly control patients with the~     primary endpoint being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal~     glucose levels not requiring medication). The main working hypothesis is that RYGB and SG~     achieves better glycemic control than the best treatment availed for the T2DM based on more~     effective mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and~     blood pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy~     safe for the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy~     surgery and intensive non surgical treatment reverse or reduce the progression of~     microvascular complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy~     realize a return on investment within 2 years in patients with type 2 diabetes who are at~     risk of developing or deteriorating microvascular complications?~   "
82729|NCT01974531|"~     The purpose of the present prospective study is the analysis of risk and protective factors~     of perinatal stress and psychological distress of parents with or without a preterm child.~     Stress is measured biologically by Cortisol levels and psychologically by a questionnaire.~     Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress~     disorder, burnout) are measured by various questionnaires. We analyze the influence of~     different aspects as personality traits, social support, partnership.~   "
82730|NCT01974518|"~     The purpose of this study is to compare the effectiveness of rituximab alone vs combination~     of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to~     routine medications.~   "
82731|NCT01974505|"~     Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal~     intubation. This study will investigate learning curve of Optiscope by anesthesia providers.~   "
82732|NCT01974492|"~     In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts~     that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation~     that remodeling of saphenous vein graft differs between those harvested from upper leg vein~     and lower leg, this study aims to compare histologic and immunohistochemical findings~     between saphenous vein grafts harvested from upper leg and lower leg.~   "
82750|NCT01974258|"~     This study will evaluate the maximum tolerated dose and dose-limiting toxicities of~     vemurafenib and/or cobimetinib when used with onartuzumab in cancer patients.~   "
82763|NCT01974089|"~     To determine the prevalence of dysphagia among Danish patients hospitalized with pneumonia~     and to test whether it is possible to reduce the swallowing disorders by changing the~     consistence of food and drink. Patients hospitalized in the period from the 1st of September~     2013 to the 31st of March 2014 will be tested by an occupational therapist for dysphagia~     within the first 24 hours of their hospitalization. The endpoints will be number of~     hospitalization days, rehospitalisation and mortality. If the test is positive, the patient~     will get a diet of a manageable consistency to avoid dysphagia.~   "
82764|NCT01974076|"~     This study will investigate whether transcranial direct current stimulation (tDCS) can~     enhance the efficacy of cognitive behavioural therapy for the treatment of depression.~   "
82733|NCT01974479|"~     Modern therapy for patients with B-lineage acute lymphoblastic leukemia (ALL) is based on~     intensive administration of multiple drugs. In patients with relapsed disease, treatment~     response is generally poor; for most patients, particularly those who relapse while still~     receiving frontline therapy, the only therapeutic option is hematopoietic stem cell~     transplantation (HSCT). There is no proven curative therapy for patients who relapse after~     transplant.~      Natural killer (NK) cells have powerful anti-leukemia activity. In patients undergoing~     allogeneic HSCT, several studies have demonstrated NK-mediated anti-leukemic activity. NK~     cell infusions in patients with leukemia have been shown to be well tolerated and void of~     graft-versus-host disease (GVHD) effects.~      NK cell cytotoxicity is most powerful against acute myeloid leukemia (AML) cells, whereas~     their capacity to lyse ALL cells is generally low. We have developed a novel method to~     expand and redirect NK cells towards CD19, a molecule highly expressed on the surface of~     B-lineage ALL cells but not expressed on normal cells other than B-lymphocytes. In this~     method, donor NK cells are first expanded by co-culture with the cell line K562-mb15-41BBL~     and interleukin (IL)-2. Then, the expanded NK cells are transduced with a signaling receptor~     that binds to CD19 (anti-CD19-BB-zeta). NK cells expressing these receptors showed powerful~     anti-leukemic activity against CD19+ ALL cells in vitro and in an animal model of leukemia.~      This study will assess the feasibility, safety and efficacy of infusing expanded, activated~     redirected NK cells into research participants with B-lineage ALL who have persistent~     disease after intensive chemotherapy . In this same cohort, we will study the in vivo~     lifespan and phenotype of these redirected NK cells.~   "
82734|NCT01974466|"~     To compare different goals of fluid resuscitation in early stage of acute pancreatitis~   "
82735|NCT01974453|"~     Radiation issue during percutaneous coronary interventions is an important issue for~     operators due to the long term stochastic risk of cancer induction, but is often~     under-evaluated. Many factors may be associated with the radiation dose adsorbed by~     operators. In particular the most important are the position taken by the operator, the use~     of dedicated X-ray shield and the duration of the procedure. However other factors (as~     operator height or the angulation of the radiation tube) might have some important effects~     but are often under-evaluated .~      Aim of our observational study is to evaluate the most important determinants of the~     radiation dose adsorbed by operators during different coronary procedures (diagnostic~     coronary angiography or percutaneous coronary interventions) and through different vascular~     accesses (right or left transradial approach or transfemoral approach).~      All patients who underwent to percutaneous coronary diagnostic or interventional procedures~     will be enrolled in this observational study.~      Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax~     level outside the lead apron and at head level to evaluate the radiation dose at~     crystalline. Effective doses delivered to patients will be expressed as dose area product~     (DAP) and measured in Gycm2.~   "
82736|NCT01974440|"~     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)~     administered in combination with either bendamustine and rituximab (BR) or rituximab,~     cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants~     with previously treated indolent Non-Hodgkin lymphoma.~   "
82737|NCT01974427|"~     Objective:~      The goal of this protocol is to improve understanding scale-free brain activity and~     conscious vs. unconscious processing by performing small behavioral, electrophysiological,~     neuroimaging and brain stimulation pilot substudies. This research is expected to help~     develop techniques and hypotheses for future research on these topics.~      We will conduct:~        -  Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough~          information to generate a hypothesis. The criterion for transition to a new full~          protocol will be acquisition of sufficient information to generate a power analysis.~          There are no enrollment limitations for pilot substudies.~        -  Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be~          tested that can be completed with a few healthy volunteers or patients.~          Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6~          subjects (if there is one group) or after 12 (6 per arm) if two groups are studied~          before additional subjects are recruited. In the event of subject dropout or~          unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will~          decide whether to continue the hypothesis substudy with more subjects without an~          amendment or whether an amendment or new protocol would be necessary. A memo requesting~          a review of hypothesis-testing substudies for possible additional enrollment will be~          sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB.~        -  Technical development of new experimental paradigms and data analysis methods.~      This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG,~     tDCS).~      Study Population:~      We plan to recruit up to 120 healthy volunteers aged 18-65.~      Design:~      We will design small projects that are pertinent to the theme of scale-free brain activity~     and conscious/unconscious processing. We will investigate healthy volunteers in the resting~     state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy~     leads to results of interest and if a larger population is necessary to reach statistical~     significance, a separate protocol will be submitted with a priori hypotheses, specific study~     design and power analysis adapted from the pilot or exploratory substudies performed in the~     present protocol.~      In the substudies, brain activity of healthy human volunteers will be monitored by~     functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG),~     electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in~     some subjects to allow better localization of brain dynamics. Because transcranial~     direct-current stimulation (tDCS) is ideally suited to modulate the slow component of~     scale-free brain activity, we will also investigate the effect of tDCS on brain activity~     and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially,~     but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments~     will be conducted in conjunction with cognitive tasks. In some experiments, we will study~     resting-state brain function, during which spontaneous brain activity is collected without a~     specific externally administered task.~      Outcome Measures:~      MRI: to analyze measures such as the anatomical structures of the brain (using structural~     MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI);~     cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter~     levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)].~      EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials,~     synchronization/desynchronization, and coherence between sensors or sources located close to~     the brain areas of interest.~      tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.~      Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography~     (EMG) patterns.~      We may measure autonomic data during the course of the experiment (such as heart rate,~     respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome~     measures.~   "
82738|NCT01974414|"~     The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic~     oral lichen planus ( a common oral problem).~   "
82739|NCT01974401|"~     in this study , effectiveness of supragingival irrigators containing chlorhexidine is~     compared with routine oral health measures in patients with blood dyscrasia whom can not use~     effective oral health measures(e.g brushing ) due to their systemic~     condition(e,g,neutropenia ,thrombocytopenia,..)~   "
82740|NCT01974388|"~     Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by~     both restrictive and hormonal action.~      Consecutive patients with morbid obesity treated by LSG at our department were evaluated.~     Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm~     from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary~     outcome measure was the % of excess weight loss (%EWL); secondary outcomes included~     operative time, day to resume oral feeding, postoperative morbidity and mortality,~     improvement of comorbidity.~   "
82741|NCT01974375|"~     The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100~     mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according~     to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.~   "
82742|NCT01974362|"~     In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic~     Zirconia, compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially~     stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has~     less post-insertion complications after 1-Year follow-up ?~   "
82743|NCT01974349|"~     Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244;~     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers~   "
82744|NCT01974336|"~     The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has~     been identified by some studies in children without short bowel syndrome(SBS).Most of the~     adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the~     lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in~     our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in~     adults with short bowel syndrome.~   "
82745|NCT01974323|"~     This study will assess the safety and efficacy of dapsone gel versus vehicle control in~     patients with acne vulgaris.~   "
82746|NCT01974310|"~     Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated~     by surgically removing the vitreous gel and injecting intraocular gas. Following macular~     hole surgery, face-down positioning is often advised with the aim of improving the~     likelihood of macular hole closure. The current evidence of postoperative positioning~     protocols is insufficient to draw firm conclusions and guide practice. The investigators~     wish to compare non-face-down positioning and face-down positioning after surgery for~     macular holes in a randomized trial.~      Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery~     for macular holes.~   "
82751|NCT01974245|"~     Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially~     in those undergoing dialysis. The loss of protein to the dialysis solution seems to~     contribute significantly to the reduced serum levels of vitamin D in these patients. As a~     result of the disease and the dialysis procedure, there is high prevalence of chronic~     inflammation and high risk of infections. There is evidence in other populations, that~     vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an~     antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus,~     this study aims to investigate the effects of cholecalciferol supplementation on~     immunological markers in patients in hemodialysis and peritoneal dialysis with~     hypovitaminosis D . This is a randomized, double-blind, placebo-controlled trial in which~     patients who have vitamin D deficiency [25 (OH) D <20 ng / mL] will be allocated to the~     intervention group (cholecalciferol) or control (placebo). Patients will receive~     supplemented 100,000 IU / week cholecalciferol a period of 12 weeks. Before and after the~     intervention will be determined 25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis~     factor-α (TNF-α) and C-reactive protein serum. In monocytes, we will evaluate cathelicidin,~     IL-6 and TNF-α, 25(OH)D receptor and α 1-hydroxylase enzyme expression.~   "
82752|NCT01974232|"~     This is a retrospective analysis of children (≤21years old) who received clinical treatment~     with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children~     included in this study were from Weill Medical College of Cornell University, New York, New~     York and Children's Hospital Orange County, Orange, California~   "
82753|NCT01974219|"~     In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS~     conditions is the accelerated development of chronic obstructive pulmonary disease (COPD), a~     disorder associated with significant morbidity and mortality. Based on the knowledge that~     COPD in smokers starts in the small airway epithelium, this study is focused on examining~     the hypothesis that the accelerated development of COPD associated with HIV infection~     results, in part, from an interaction of HIV directly on the small airway epithelium or~     through infection of cellular components of the immune system, with mediators released by~     these immune cells evoking premature biologic aging of the small airway epithelium. By~     identifying the early events in the pathogenesis of the HIV-associated accelerated COPD in~     smokers, we aim to identify biologic targets to which pharmacologic therapies could be~     addressed.~   "
82754|NCT01974206|"~     The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in~     reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects~     receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety~     of ASP0113 in this patient population.~   "
82755|NCT01974193|"~     Pelvic lymph node dissection (PLND) is an important step in the surgical staging and~     treatment of gynecologic malignancies.~      Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including~     chemotherapy and radiation therapy, which potentially affects the success of cancer~     treatment.~      A number of surgical techniques have developed, but failed to reduce the incidence of pelvic~     lymphoceles after PLND.~      The investigators hypothesized that floseal can prevent lymphoceles in patients with~     gynecologic cancer who has undergone PLND.~      The investigators designed prospective randomized controlled study as a pilot study.~      The investigators will randomly apply floseal to one side of pelvis after bilateral PLND,~     and observe the occurence of pelvic lymphoceles after 6 months later.~   "
82756|NCT01974180|"~     Early changes associated with the development of smoking-induced diseases, e.g., COPD and~     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal~     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells~     necessary for generation of differentiated airway epithelium. Based on our preliminary~     observations that epidermal growth factor receptor, known to regulate airway epithelial~     differentiation, is enriched in BC and its ligand EGF is induced by smoking, we hypothesized~     that smoking-induced EGF alters the ability of BC to form normally differentiated airway~     epithelium. To test this, airway BC will be purified using a cell-culture method established~     in our laboratory and responses to EGF will be analyzed using genome-wide microarrays and an~     in vitro air-liquid interface model of airway epithelial differentiation.~   "
82757|NCT01974167|"~     The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy~     compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis,~     using a randomized, open-label, parallel-group, comparative design.~   "
82758|NCT01974154|"~     Cigarette smoking is the major cause of chronic obstructive pulmonary disease (COPD), the~     4th cause of mortality in the US. Central to COPD pathogenesis is ciliopathy, dysfunction~     of the airway ciliated cells that mediate transport of mucus to remove inhaled pathogens.~     The focus of this study is to carry out metabolic profiling of banked biologic samples and~     assess the hypothesis that COPD is associated with a unique metabolome in serum and lung~     epithelial lining fluid, and that subsets of the COPD metabolome are linked to the~     ciliopathy of COPD.~   "
82759|NCT01974141|"~     This study will assess the safety and efficacy of dapsone gel versus vehicle control in~     patients with acne vulgaris.~   "
82760|NCT01974128|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?~   "
82761|NCT01974115|"~     Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment~     of cellulite over the last years. The purpose of this study is to test the following~     hypotheses: (i) cellulite can be efficiently and safely treated using the radial~     extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon,~     Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can~     be predicted by means of the patient's individual cellulite grade at baseline, the patient's~     individual age, body mass index (BMI), weight, and/or height.~   "
82762|NCT01974102|"~     The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a~     pilot sample of parents of toddlers and engaging them in a pilot study to test a version of~     mindfulness-based stress reduction (MBSR), an empirically-supported stress-reduction~     intervention, plus nutrition and physical activity counseling for parents of preschoolers~     (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy~     eating and physical activity in parent and child; and prevent overweight and obesity in~     preschoolers with an obese parent.~   "
82765|NCT01974063|"~     Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell~     population that takes the brunt of the stress of cigarette smoke and the cell population~     central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer.~     The focus of this study is to identify the differences that two popular alternative nicotine~     delivery strategies, shisha and electronic cigarettes, have on the airway epithelium~     compared to cigarette smoking. We hypothesize that both alternative nicotine delivery~     strategies disorder airway epithelial biology, but in different ways than does cigarette~     smoking.~   "
82766|NCT01974050|"~     In this study, the investigators will prospectively assess fever rates and other adverse~     events in pregnant women after administration of inactivated influenza vaccine (IIV) using~     text messaging. The investigators hypothesize that women <20 weeks gestational age who~     receive IIV will be willing to enroll in a text messaging-based vaccine adverse event~     monitoring program and will use it to report fever in the post-vaccination period as well as~     continue to text pregnancy-related outcomes through the end of their pregnancy.~   "
82767|NCT01974037|"~     Excess dietary salt intake is closely associated with the development of hypertension and~     cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory~     cortices change. This study focuses on examining the neuroimaging changes of salty gustatory~     cortices under different concentration of NaCl solution with or without capsaicin~     intervention through brain PET/CT scan.~   "
82768|NCT01974024|"~     The aims of this study were to investigate the feasibility of methylprednisolone rotation as~     treatment of DIH~   "
82769|NCT01974011|"~     Dorsal penile nerve block (DPNB) is a regional nerve block probably most often performed~     throughout the world. There are several different methods described in the literature. When~     compared to penile ring wall infiltration or caudal block, the Dorsal penile nerve block~     (DPNB) is more likely associated with the risk of failure of the block quality. The aim of~     this study is to compare the quality of the standard method of Dorsal penile nerve block~     (DPNB)(Dalens' technique) with that of a modified procedure (Dorsal penile nerve block~     (DPNB)with additional infiltration of the ventromedial penis at the transition between the~     penis and the scrotum.~   "
82770|NCT01973998|"~     Background: COPD exacerbations add considerably to patients' burden because they: (1) cause~     frequent hospital admissions and relapses or readmissions, (2) contribute directly to the~     death of many patients, either during hospitalization or shortly thereafter, (3) cause~     patients significant stress, prolonged physical discomfort, disability and dramatically~     reduced quality of life, (4) consume the majority of the resources available to manage this~     chronic condition, (5) frequently progress to a severe stage warranting hospitalization~     before any abortive treatment is instituted, and (6) may hasten the progressive loss of lung~     function, a steady decline that is a cardinal feature of COPD itself. Hence, investigations~     of new therapies to treat COPD patients who are hospitalized with a severe exacerbation are~     desperately needed.~      Objective: To test the feasibility of roflumilast to decrease all cause readmission and~     mortality 180 days after hospitalization for acute COPD exacerbation.~      Methods: Parallel-group, prospective, randomized, double blind, placebo-controlled trial of~     roflumilast 500 ug daily vs. placebo in approximately 100 hospitalized AECOPD patients.~     Inclusion Criteria. Primary diagnosis of AECOPD; admission to the hospital <12 hours;~     patient age >40, < 80 years old; cigarette smoking > 10 pack-years. Exclusion Criteria.~     Prior diagnosis or high suspicion for asthma; pulmonary edema, pneumonia, interstitial lung~     disease or significant bronchiectasis; intubated and mechanically ventilated at the time of~     evaluation; active liver disease, or transaminase elevations (> 3xULN); history of heavy~     ethanol use; history of suicidal behavior ≤ 2 years or suicidal ideation ≤ 6 months prior to~     enrollment; pregnant or lactating females. Those on the following excluded medications: P450~     inducers and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2~     simultaneously~   "
82771|NCT01973985|"~     Pleural effusion is an extremely common problem with multiple causes; its subsequent~     investigation with thoracocentesis and treatment with drainage represent two of the most~     frequently performed diagnostic and therapeutic medical procedures. The role of thoracic~     ultrasonography in the management of pleural effusion is a modern and rapidly expanding one,~     having become effectively mandatory and part of the gold standard over the past decade due~     to its diagnostic and patient safety benefits. By contrast, the measurement of intra-pleural~     pressure using sequential manometry has failed to convincingly demonstrate its clinical~     value beyond physiological studies despite its availability for over a century. Previous~     work has shown a potential role for pleural manometry in predicting the presence of~     un-expandable lung and success of talc pleurodesis but these studies have not been~     replicated or clinically validated.~      We intend to combine the old and new in an observational study comparing findings on~     thoracic ultrasonography and pleural manometry during thoracocentesis with patient-reported~     symptoms and the key clinical outcomes of presence of un-expandable lung and success of talc~     pleurodesis. The investigators hypothesise that the previously described variations in~     pleural elastance can be correlated with appearances and anatomical changes visualised on~     thoracic ultrasonography; and in combination can be reliably utilised to predict clinical~     outcome. The study may allow the proposal of a treatment algorithm that allows patients with~     pleural effusion to be managed in a more expeditious and efficient manner.~   "
82772|NCT01973972|"~     The proposed research will test a novel program that combines intensive weight management~     with shared (group) medical appointments for patients with diabetes. This research is~     important because diabetes is increasingly prevalent, it requires complex management by the~     provider and the patient, and weight loss is a critical component of its management. Adding~     weight management to shared medical appointments could potentially improve blood sugar~     control while reducing medications and their side effects such as low blood sugar.~   "
82773|NCT01973959|"~     Anaesthesiology plays a key role in promoting safe perioperative care. This includes the~     perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete~     information transfer may have a negative impact on patient safety and can lead to patient~     harm. The objective of this study is to analyse information transfer during postoperative~     handovers in the PACU.~      With a self-developed checklist information transfer during postoperative handovers will be~     documented and subsequently compared with patient information in anaesthesia records.~   "
82785|NCT01973803|"~     This study is to evaluate the performance of the Articulinx ICMC~     (InterCarpoMetacarpalCushion) in the carpometacarpal joint (CMC joint) and to describe the~     clinical results in patients who have been treated with this device. Expected results~     include the relief of symptoms and improvement of function in patients with symptomatic~     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved~     through measurements of pain, pain medication use, and joint function in up to 40 subjects.~     Each subject will be compared to their pre-surgery status for each endpoint.~   "
82774|NCT01973946|"~     The purpose of this prospective trial is to test a daily telephone based automated symptom~     monitoring and response system to track and further treat unrelieved symptoms for patients~     living at home during chemotherapy treatment as compared with usual care which consists of~     patients calling their oncology provider for symptom concerns. For the intervention group,~     the monitoring system is paired with automated delivery of self-care suggestions tailored to~     the specific symptom profile the patient reported and also automatically 'alerts' the study~     oncology nurse practitioner about unrelieved symptoms. The nurse practitioner, utilizing~     national evidence based symptom guidelines for symptoms at moderate to severe levels calls~     the patient and further assesses and intensifies symptom treatment. The usual care group~     called the system daily and reported similar data but did not receive self-care coaching or~     notification of unrelieved symptoms to the study nurse practitioner. On every call, the~     usual care group was told to follow the standard procedure of calling their oncology~     providers for symptom concerns. The specific aims of the study are to test whether the~     symptom monitoring intervention reduces presence, severity and distress of 11 symptoms. The~     symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness &~     tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed~     mood, anxiety, and fatigue. Secondary outcomes tested whether the intervention improved~     functional performance and decreased interference with activity when compared with the usual~     care attentional control group. Other aims compare self care strategies utilized and their~     perceived effectiveness and document patient satisfaction with the monitoring system.~   "
82775|NCT01973933|"~     This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of~     pyrimethamine and metformin IR after oral administration in healthy male volunteers.~   "
82776|NCT01973920|"~     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism~     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current~     methods of insulin therapy for diabetic patients are multiple daily injection therapy and~     continuous subcutaneous insulin infusion with an external pump. This rout of administration~     may lead to hyperinsulinemia as insulin is administered in a non physiological way,~     targeting mainly extra hepatic tissues (muscle, fat). A method of providing insulin without~     the need for injections has been a goal in drug delivery.~      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on~     biochemistry and quantum theory of biochemical reactions. The carrier enables the absorption~     of proteins from the gastrointestinal tract in their full structure. Oshadi has also~     developed the Oshadi Icp - insulin, proinsulin and C-peptide in Oshadi carrier,~     administrated orally. This study was design in order to evaluate the safety and feasibility~     of multiple administrations of Oshadi Icp for home use. The study will be a multiple-dose,~     open-label non-randomized study in patients with Type 1 diabetes, with periodic dose~     adjustments. The study will include 4 weeks of multiple-dose administration of Oshadi oral~     insulin (Oshadi Icp) at home and in study center for the determination of the efficacy,~     safety and pharmacodynamic effects of Oshadi Icp.~   "
82777|NCT01973907|"~     The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results~     in the best outcomes for children treated for suspected or confirmed septic shock. In this~     study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid~     Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock~     Resuscitation Guidelines, with the assigned resuscitation strategy used to guide~     administration of further fluid boluses as well as the timing of initiation and escalation~     of vasoactive medications to achieve ACCM recommended hemodynamic targets.~   "
82778|NCT01973894|"~     This study investigates what independent variables may influence Midazolam Pharmacokinetics~     in critically ill patients.~   "
82779|NCT01973881|"~     This study is for the development and validation of functional magnetic resonance imaging~     (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to~     treatment in patients with myelofibrosis.~   "
82780|NCT01973868|"~     To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in~     combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RP2D)~   "
82781|NCT01973855|"~     To meet eligibility criteria, this study and informed consent of the syndrome of fever~     associated with bleeding of infectious diseases, severe patients to carry out multicenter,~     practical randomized controlled clinical research, to compare the curative effect of western~     medicine, combining Chinese and western medicine treatment, and security, and pathogenesis~     of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese~     medicine, Chinese medicine prescriptions mechanism research.~   "
82782|NCT01973842|"~     The present study aims to investigate whether the dosage of the GnRH agonist used for~     triggering final oocyte maturation affects the maturity of the oocytes retrieved in high~     risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and~     recombinant FSH.~   "
82783|NCT01973829|"~     The purpose of the study is to test whether the health care provider access and training in~     CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate~     timely and error free best-practice delivery and minimize preventable death and costly~     complications in critically ill patients.~   "
82784|NCT01973816|"~     The purpose of this study is to determine whether, in women with deep endometriosis~     involving the rectum and not intending to get pregnant, continuous hormonal treatment would~     be followed by better digestive functional outcomes than curative rectal surgery. Are~     included women from 35 to 50 years presenting with deep endometriosis infiltrating at least~     the muscular layer of the rectum and not having pregnancy intention.~      The main outcome concerns the quality of digestive function 24 after the onset of the~     treatment, assessed using a composite variable: patient considering that digestive function~     is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the~     Gastrointestinal Quality of Life Index (GIQLI) score >100.~      Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel~     movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of~     life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score,~     the rate of postoperative complications, medical treatment adverse outcomes, the rate of~     additional endoscopic and surgical procedures.~      The randomization is central, once the physician asses the diagnosis, explain the study's~     principle and rece In the arm A, the patients received triptoreline and add back therapy by~     estradiol during 6 months, followed by daily intake of cyproterone acetate and add back~     therapy during 18 months.~      In the arm B, patients are managed by rectal surgery (depending on the surgeon choice:~     rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of~     recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.~      The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24~     months. The length of the follow up is 24 months. The patients have 8 visits in the arm A,~     and 7 visits in the arm B.~      Eleven French tertiary referral centres will enrol patients in the trial.~   "
82787|NCT01973777|"~     The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device~     consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain~     and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an~     initial pilot of 15 women, there were no complications during the 12 months. This~     observational pilot study of 50 women will determine that the early expulsion rate is not~     greater than 10% and that there is patient and physician acceptance, so that we can plan a~     larger randomized controlled trial for efficacy and safety.~   "
82788|NCT01973764|"~     Puncture of the ventricular system is one of the most frequently performed neurosurgical~     interventions. This procedure is commonly performed in order to treat and/or measure~     pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure~     is needed. Currently the landmark-based placement of intraventricular catheters is the~     gold standard. However it is known that more than 60% of the catheters are not accurately~     placed in accordance with landmark-based procedures. When the catheter is not placed~     accurately multiple punctures may be required. In this study, the investigators aim to~     investigate prospectively whether ultrasound guidance leads to a lower number of incorrect~     catheter placements, and whether this guidance consequently decreases the number of~     punctures.~   "
82789|NCT01973751|"~     Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description:~     This will be a single center study of asthmatic subjects and healthy controls which will~     investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay~     of asthma therapy. Only about half of the asthmatic patients have improved lung function~     after treatment of inhaled corticosteroid. The investigators hypothesize that there are~     biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of~     asthmatic patients which could predict the response of asthmatic patients to inhaled~     corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the~     optimal treatment for individual asthmatic patient.~   "
82790|NCT01973738|"~     Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene~     (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to~     compare clinical efficacy and safety between RLX and BZA.~   "
82791|NCT01973725|"~     Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic~     Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.~   "
82792|NCT01973712|"~     A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of~     fracture is often difficult to fix because of the close proximity of the two surgical~     implants which can sometimes interfere with proper bone healing. Improper healing can cause~     significant impairment and sometimes requires additional surgeries to correct the problem.~     Despite considerable interest and research put into developing techniques to repair this~     fracture surgeons do not know which is the best way to treat this type of fracture.~      Our multicentre orthopaedic study group is conducting this study to compare two standard,~     but different treatments for periprosthetic distal femur fractures. One treatment consists~     of open surgery and the placement of a plate and screws along the side of the femur. The~     other consists of implanting an intramedullary nail in the femur.~      The goal of this study is to directly compare the two treatments to see if one treatment~     results in better patient outcomes than the other.~   "
82793|NCT01973699|"~     Adequate visualization during shoulder arthroscopy is of great importance for the procedure~     to be efficiently and effectively performed. The use of dilute epinephrine in irrigation~     fluid has been historically utilized to help with visualization. Given the potential safety~     issues documented in the literature related to epinephrine use, as well as the significant~     improvements in technique and instrumentation over the last decade, the need for this~     additive should be reexamined. The objective of the current study was to compare surgeon~     determined visualization in shoulder arthroscopy using irrigation fluid with and without~     epinephrine.~   "
82794|NCT01973686|"~     The aim of the present study is to investigate the changes in body composition and the~     degree of compensation to exercise induced energy expenditure after 1 year of physical~     activity with either moderate or vigorous intensity in overweight and class 1 obese men and~     women. The present study is a sub study to main study Active Commuting To Improve~     Well-being and Health in Everyday Life (NCT 01962259)~   "
82795|NCT01973673|"~     Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT)~     are at increased risk of developing bone loss and osteoporosis as side effects. To prevent~     this, guidelines recommend participation in healthy bone behaviours including weight-bearing~     exercise and adequate calcium/vitamin D intake. However, prior studies have shown that~     patients are not regularly screened or counselled regarding healthy bone behaviours while~     receiving ADT. Maintaining bone health in prostate cancer patients is important because men~     on ADT are at increased risk of fractures. In this study, the investigators will examine~     whether an intervention designed to improve healthy bone behaviours among prostate cancer~     patients on ADT can be implemented. The intervention consists of a written healthy bones~     prescription, brief verbal counseling, and printed educational materials for participants.~     Investigators hope to obtain an initial estimate of whether the intervention works. They~     also hope to show that this simple intervention can be implemented in a real, working cancer~     clinic.~      The investigators hypothesize that an intervention to improve bone health in prostate cancer~     patients receiving ADT (healthy bones prescription, verbal counseling, and printed~     educational materials) is effective, implementable, and accepted by clinicians and patients.~   "
82796|NCT01973660|"~     Non-randomized, open label, multicentric translational research study in women with~     untreated invasive breast carcinoma eligible for primary surgery (Stage I-IIIA).~      The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better~     predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy,~     compared to traditional clinical HER2 classification. Furthermore, we posit that~     characterization of gene expression patterns may identify profiles of those who may be~     safely spared chemotherapy.~   "
82846|NCT01972997|"~     This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes~     on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4~     24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor~     lens sizes is placed on the eye in the different sessions. Subjects visit the study site for~     installation and removal of the device and accompanying exams, but remain ambulatory during~     the recording.~   "
82797|NCT01973647|"~     Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in~     people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality,~     with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also~     related to greater morbidity, with 75% greater health care costs than people without~     insomnia. However, insomnia medications are used with caution in COPD due to potential~     adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and~     depression also affect insomnia and can interfere with therapy outcomes. While cognitive~     behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing~     unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia~     and people with other chronic illnesses, the efficacy and mechanisms of action of such a~     therapy are yet unclear in people with both insomnia and COPD. The objective in this~     application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and~     COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify~     mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and~     COPD-ED will have positive, lasting effects on objectively and subjectively measured~     insomnia and fatigue. The rationale for the proposed study is that once the efficacy and~     mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia~     coexisting with COPD can be developed, thereby leading to longer, higher quality and more~     productive lives for people with COPD, and reduced societal cost due to the effects of~     insomnia. The investigators plan to test our central hypothesis by completing a randomized~     controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention~     control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of~     CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design~     will allow completion of the following Specific Aims: 1. Determine the efficacy of~     individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define~     mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in~     this application is innovative because it represents a new and substantive departure from~     the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance~     outcomes.~   "
82798|NCT01973634|"~     Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer~     halves the recurrence risk and reduces the breast cancer death by about one sixth. A~     sequential boost (SeqB) dose to the tumour bed further improves local control, but also~     increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital~     WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation~     scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the~     overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI,~     the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time~     which is convenient for the patient and the radiotherapy department. In this study we wish~     to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using~     hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose~     painting, a technique recently developed in our group. Patients are randomized between SeqB~     and SIB.~   "
82799|NCT01973608|"~     This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to~     assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445~     given by intravenous infusion to subjects with advanced (unresectable or metastatic)~     melanoma in combination with stereotactic body radiation therapy (SBRT).~   "
82800|NCT01973595|"~     The purpose of this study is to determine whether incorporating almonds into the diets of~     families with young children will induce beneficial changes in gastrointestinal function,~     the fecal microbiota profile, and immune and inflammatory processes of the adults and~     children resulting in improved quality of life. The investigators anticipate finding an~     increase in beneficial bacteria, improved intestinal function, and decreased inflammation~     during the almond intervention.~   "
82801|NCT01973582|"~     Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1,~     1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis~     B carrier rate as well as liver diseases among children and adolescents. The sexual~     transmission route is another important way of hepatitis B infection aside from the mother~     and child vertical infection, especially for youth and adults. Hepatitis B vaccination~     cohort refers to those who were born after 1986 and received hepatitis B vaccine~     immunization during newborn period. They are gradually entering into young adults and~     adolescent age. Among them, there is no empirical evidence to show the actual infection rate~     and to help implement hepatitis B vaccine booster policy for those who had three~     seronegative viral markers of hepatitis B. Therefore, the study design is to collect three~     consecutive years graduate school students school entry health examination data and undergo~     three hepatitis B viral markers checkup and blood types. The data linkage includes their~     health checkup data in the freshmen period, Taiwan CDC databank for neonatal hepatitis B~     immunization records, pregnancy and birth record registry, Taiwan cancer registry and Taiwan~     death record registry.~   "
82802|NCT01973569|"~     To evaluate the inhibitory effect of progression, compared with placebo, in joint~     destruction by AMG 162 administered subcutaneously to rheumatoid arthritis patients~   "
82803|NCT01973556|"~     Patients managed by a newly formed pharmacist-physician medication therapy management team~     in a university primary care clinic will have better blood pressure control than patients~     receiving usual care.~   "
82804|NCT01973543|"~     Safety study of AADC gene transfer in subjects with Parkinson's disease.~   "
82805|NCT01973530|"~     We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior~     analgesics and rehabilitation ability than continuous femoral nerve block for postoperative~     patients receiving total knee arthroplasty.~   "
82806|NCT01973517|"~     Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron~     oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO).~     In this project we hypothesize that Feraheme could become a sensitive and specific marker of~     active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage~     of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast~     agent Feraheme at revealing inflammatory activity.~   "
82807|NCT01973504|"~     MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at~     risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to~     improve perfusion and target delivery of oxygen to ischemic tissues. This study will~     evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma~     patients suffering from lactic acidosis due to severe hemorrhagic shock.~   "
82808|NCT01973491|"~     This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to~     evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing~     multiple sclerosis (MS) and to assess the maintenance of any such effects.~   "
82935|NCT01971840|"~     Coordinated project whose objectives are: a) to assess the effectiveness of a physical~     activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the~     adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the~     carotid intima-media thickness.~   "
82809|NCT01973478|"~     Major depressive disorders are real public health issues in terms of diagnosis and~     treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these~     forms suicide risk is important.~      Patients with TRD are potential candidates for neurosurgical interventions to treat~     depression. However, psychosurgery interventions based upon lesions, showed their~     limitations related to 1. the large variability in neurosurgical gestures, 2. their side~     effects, and of course 3. the irreversible damage caused by the surgery.~      Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering~     from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed~     encouraging results. The investigators have thus planned a randomized controlled trial~     versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.~   "
82810|NCT01973465|"~     This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for~     CDI. The weight of the evidence in the literature suggests that FMT is the most effective~     treatment for ambulatory outpatients affected by recurrent CDI who fail conventional~     therapy.~      The anticipated benefits to research patients enrolled in this study include resolution of~     chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of~     chronic recurrent CDI.~      FMT involves the endoscopic instillation of freshly obtained stool with millions of live~     bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure,~     there is a risk of perforated viscous. This is very rare, but the risk is increased with~     severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears~     to be negligible.~   "
82811|NCT01973452|"~     The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex),~     can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of~     opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food &~     Drug Administration) for use as a sedative in hospitals and is currently used in the~     investigators Intensive Care Unit for this purpose. The investigators want to investigate if~     it also has pain relieving properties.~   "
82812|NCT01973439|"~     To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir~     in HIV-1-infected infants and children aged 3 months to 36 months~      The secondary objectives of PENTA15 were:~      To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in~     HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine~     in combination with abacavir~      To compare age-related differences in the PK parameters of q24h versus q12h dosing of~     abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24~     months and ≥24 to <36 months)~      To describe child and family acceptability of and adherence to q24h compared to q12h dosage~     regimens of abacavir and lamivudine~   "
82813|NCT01973426|"~     We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can~     effectively facilitate the ability of participants to perform a specific set of clinically~     relevant tasks conducted in a clinic setting.~   "
82814|NCT01973413|"~     The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced~     control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp~     setting will allow us to obtain pilot efficacy data.~   "
82815|NCT01973400|"~     Given that the tocotrienols have been shown to possess neuroprotective effects and that both~     type 1 and type 2 diabetes can lead to peripheral neuropathy and cognitive impairment, the~     present study aims to determine the beneficial effects of tocotrienols in ameliorating such~     neurological related events in both type 1 and type 2 diabetic patients.~   "
82816|NCT01973387|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus~     rituximab in adult Asia Pacific region patients with relapsed or refractory chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
82817|NCT01973374|"~     Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to~     adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can~     be minimized with tight glucose control. A number of studies in non-pregnant populations~     have highlighted the feasibility, acceptability and efficacy of text messaging interventions~     for improving diabetic compliance and control. This study will investigate whether a text~     messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and~     whether this intervention can improve compliance with diabetes care, glucose control and~     pregnancy outcomes. The study will also assess satisfaction with the intervention itself.~   "
82818|NCT01973361|"~     The UltraHeal Study is a randomized controlled trial to compare healing response of low~     frequency contact ultrasonic-assisted debridement in addition to best practice wound care to~     best practice wound care alone in a Vascular Surgery Clinic patient population with wounds~     of the lower extremity.~   "
82819|NCT01973348|"~     Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia,~     which intermittently become opaque and provide effective occlusion for 50% of the time they~     are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the~     amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized~     clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.~      Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective~     as traditional patching treatment.~      The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the~     standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the~     standard 6-hour patching treatment.~      This study is designed to evaluate the effectiveness of a novel amblyopia treatment,~     AmblyzTM glasses, in treating amblyopia.~      Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the~     amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses~     treatment group and standard 2-hour patching control group.~      Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the~     amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses~     treatment group and standard 6-hour patching control group.~   "
82820|NCT01973335|"~     This study has two primary objectives:~        1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus~          high-dose loop diuretics (standard of care) in patients with acute decompensated heart~          failure at high risk for diuretic resistance.~        2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in~          addition to loop diuretic therapy in patients with acute decompensated heart failure at~          high risk for diuretic resistance.~   "
82821|NCT01973322|"~     Title: Vaccination with autologous dendritic cells loaded with autologous tumor lysate or~     homogenate combined with immunomodulating radiotherapy and/or preleukapheresis IFN-alfa in~     patients with metastatic melanoma: a randomized proof-of-principle phase II study.~      Study Design: Randomized selection design, proof of principle study Study Duration: 36~     months Number of Subjects: 24 evaluable patients~      Diagnosis and Main Inclusion Criteria: Patients with non resectable stage III or stage IV~     malignant melanoma carrying at least 2 measurable lesions, any line after 1st line~     Vemurafenib in patients carrying BRAF mutation-positive melanoma and/or ≥ 2nd line~     Ipilimumab.~      Study Product, Dose, Route, Regimen and duration of administration:~      Intradermal Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or~     homogenate on weeks 1, 4 6 and 8 during induction phase, and every 4 weeks during~     maintenance phase up to a maximum of 14 vaccine doses (each dose followed by IL-2 3 MU day~     2-6) COMBINED OR NOT WITH~        -  IFN-alfa 3 MU daily for 7 days before leukapheresis AND/OR~        -  Three daily doses of 8 Gy up to 12 Gy delivered to one metastatic field between vaccine~          doses 1 and 2 (optional to one additional field between doses 7 and 8) utilizing~          IMRT-IMAT techniques.~   "
82822|NCT01973309|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with paclitaxel.~   "
82823|NCT01973296|"~     The purpose of this study is to determine whether a new way of educating/coaching~     chronically ill patients discharged from the Emergency Room will help them receive post-ER~     health care and strengthen their links to a regular, personal doctor.~   "
82824|NCT01973283|"~     The goal of this open-administration treatment study of citalopram (or duloxetine) is to~     evaluate the effect of antidepressant medication on treating the syndrome of frailty in~     older adults with depressive symptoms. Patients with significant depressive symptoms~     (defined as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or~     more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased~     grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or~     duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome~     of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression~     clinic and eligible to participate in the study will be treated with an antidepressant~     medication and assessed on the primary outcome variables (characteristics of frailty,~     depressive symptoms) as well as on secondary variables which include cognition (global~     cognition, episodic memory, executive function), and function (physical mobility,~     instrumental activities of daily living, and social functioning) prior to treatment~     initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that~     we will discover a significant improvement on both frailty characteristics and depressive~     symptoms in this clinical population when treated with antidepressant medication (citalopram~     or duloxetine).~   "
82825|NCT01973270|"~     The purpose of this study is to determine whether cognitive training exercises can improve~     cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective,~     schizophreniform, and psychosis NOS who are being treated in community mental health~     settings. We will investigate the effects of web-based cognitive training exercises~     delivered on a portable laptop computer. The findings will provide us with valuable~     information on whether cognitive training can improve the cognition and functioning of young~     individuals early in the course of schizophrenia.~   "
82826|NCT01973257|"~     The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion~     ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted~     image with ADC value measurement, and to determine the relationship between these data and~     the degeneration of IVDs, the different posture, and different stress-loading status.~   "
82827|NCT01973244|"~     This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of a single dose of~     long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx®~     (somatropin) in children with growth hormone deficiency.~   "
82828|NCT01973231|"~     This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and~     safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2~     diabetes (T2DM).~   "
82829|NCT01973218|"~     The purpose of the study was to assess the immunogenicity and safety of two doses of~     Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0,~     1 month schedule) in Korean adolescents aged between 11 to 17 years.~   "
82830|NCT01973205|"~     The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin~     versus placebo in the acute treatment of migraine~   "
82831|NCT01973192|"~     The purpose of this study is to test the hypothesis that early viral infections alter the~     bacterial flora and inflammatory profile in the airway and accelerate progression of~     pulmonary disease in infants with cystic fibrosis.~   "
82832|NCT01973179|"~     The goal of this observational study is to evaluate the toxicity and local tumor control of~     proton therapy for patients with head and neck cancer in a previously irradiated field.~      Standard of care for recurrent or secondary malignancies in a previously irradiated field is~     surgery. For inoperable patients or residual tumor after surgery, standard of care would be~     palliative chemotherapy. For a small subset of patients (good performance status, small~     radiation fields) re-irradiation can be performed. In this study the established concept of~     re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has~     the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for~     lower toxicity.~   "
82833|NCT01973166|"~     The purpose of this study is to compare the investigational medical grade laser device to a~     marketed medical grade laser device for effectiveness in lightening or clearing unwanted~     tattoos. This study will also compare any side effects from treatment with the devices.~   "
82847|NCT01972984|"~     1. Women with operable breast cancer with a 2-8 week preoperative waiting period will~          accept preoperative therapy trials and specifically taking a standard drug for breast~          cancer such as anastrozole in this study~        2. Short term anastrozole treatment will induce measurable changes in biomarker levels~          (ER, PR, Her2, Ki67) within the tumor.~        3. Degree of response to short term anastrozole varies with a) duration of treatment and~          b) breast cancer subtype (based on initial pre-treatment biomarker status)~   "
82834|NCT01973153|"~     Leading medical organizations have called on primary care pediatricians to take a central~     role in the prevention of childhood obesity. Weight counseling typically has not been~     incorporated into routine pediatric practice due to time and training constraints. Brief~     interventions with simple behavior change messages are needed to reach high-risk children,~     particularly Latino and Black children who are disproportionately affected by obesity and~     related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled~     trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care~     clinicians and the added value of supplementing BMC with monthly contact by community health~     workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4~     years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized~     trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by~     clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic~     behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus~     monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the~     selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is~     meaningful to the mother and teaches the mother simple behavioral strategies. Monthly~     contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads~     are assessed at baseline and 12 months and the primary outcome is change in the child's BMI~     percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in~     BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI~     percentiles than BMC+Phone.~   "
82835|NCT01973140|"~     Tolvaptan is one of new class of medications approved for treatment of low blood sodium~     (hyponatremia). It works by interfering with the effect of the antidiuretic hormone,~     vasopressin, thereby increasing urine output and decreasing body water. However, the~     magnitude of these effects vary from person to person. Thus, the efficacy of tolvaptan is~     less reliable than an infusion of a concentrated salt solution for emergency, short term~     treatment of hyponatremia.~      This study is designed to test 3 hypotheses about the variable efficacy of tolvaptan.~        1. The variable effect on urine output is due to individual differences in blood~          vasopressin which counteracts the effects of tolvaptan.~        2. The differences in blood vasopressin are due to individual differences in the amount~          secreted in response to a rise in blood sodium.~        3. The variable effect on blood sodium is due mainly to the variable effect on urine~          output and can be corrected by maintaining water intake below urine output.~      The study has 2 parts and will be performed in 12 healthy adult males.~        1. Six subjects will receive tolvaptan at a dose of 60 mg by mouth and six subjects will~          receive tolvaptan at 30 mg by mouth. Blood and urine will be collected hourly for 6~          hours and water will be ingested in prescribed amounts. For the next 16 hours, subjects~          will drink at will and blood and urine will be collected 4 more times.~        2. One week later, the same subjects will receive a concentrated salt solution (3% saline)~          by vein for 6 hours. During this time, blood and urine will be collected hourly but~          drinking will not be permitted. For the next 4 hours, subjects will be allowed to drink~          at will while blood and urine are collected twice more.~      The volume, concentration and creatinine content of each urine will be determined. Blood~     will be analyzed for sodium, vasopressin and, in the first study, tolvaptan.~   "
82836|NCT01973127|"~     The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on~     the right side of the head will make craving towards alcohol less severe in recently~     detoxified alcohol addicted patients.~      Although there are successful treatment option to detoxify patients form their alcohol use,~     many patients tend to relapse. This relapse is mainly caused by a high level of~     (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing~     options hard to treat, there is a great need of new successful treatment modalities. rTMS is~     a FDA approved treatment method for depression. Recently some small scale studies have shown~     promising results on rTMS in the treatment of addiction. In this study the investigators~     focus on alcohol addiction since it is the addiction with the highest morbidity and~     mortality in the Netherlands.~   "
82837|NCT01973114|"~     The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost~     for the treatment of Menière's disease.~   "
82838|NCT01973101|"~     The purpose of this phase II study is to determine the survival free disease of patients~     diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction~     chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive~     chemoradiation.~   "
82839|NCT01973088|"~     This study intends to use in patients with renal tissue and blood samples, screening and~     identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further~     study of uric acid stone formation mechanism and the occurrence of clinical preventive uric~     acid stones provide new clues and new intervention targets.~   "
82840|NCT01973075|"~     Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an~     increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function~     leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be~     explained. Causes enlightening POI may be enumerated as follows, according to their~     frequency: genetic mutations, autoimmune defects and abnormalities detected on the X~     chromosome.The purpose of the study is to determine the frequency of the genetic~     abnormalities and polymorphisms described above in the POI Turkish population~   "
82841|NCT01973062|"~     This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in~     treating patients with recurrent or refractory primary central nervous system non-Hodgkin~     lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can~     find cancer cells and carry cancer-killing substances to them without harming normal cells.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with~     rituximab may kill more cancer cells.~   "
82842|NCT01973049|"~     To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without~     Ribavirin in treatment naive cirrhotic subjects.~   "
82843|NCT01973036|"~     Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter~     for induction in women who present with premature rupture of membranes who are not in labor.~   "
82844|NCT01973023|"~     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity~     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies~     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved~     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of~     repetitive multifocal BTI on patient's gait pattern and their duration.~      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic~     stroke patients. To that end, gait of patients has been compared using 3D-gait analysis~     after at least 2 consecutive BTI sessions.~   "
82845|NCT01973010|"~     The purpose of this study is to determine whether massage is effective in the treatment of~     low back pain and to optimize clinical therapeutic schedule of massage for low back pain.~   "
82848|NCT01972971|"~     Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the~     prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin~     may cause treatment failure and over dosing may cause bleeding because of its narrow~     therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and~     international normalize ratio (INR) periodically in order to evaluate the appropriateness of~     warfarin dosing.~      Lots of factors influencing warfarin anticoagulation effects include polymorphisms of~     Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes,~     age, weight, diet and concurrent medications. Taking into consideration of physicians' work~     load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care~     in US to ensure patient medication safety. In addition, differences in genetic polymorphisms~     between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no~     consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation~     clinics provide individualized care, consistent monitoring and patient education. Through~     this service, physicians can get the latest integrated information about their patients,~     patients themselves are more familiar with their medication, and adherence can be improved.~     Therefore, those who take warfarin will get better INR control, less adverse drug-related~     events and treatment failure.~      This is the first prototype of pharmacist clinic for a specific medication in our hospital.~     The adverse drug events and coagulation function data collected through this program can be~     used for the implementation of warfarin treatment guideline in Taiwan in the future. The~     impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge~     survey. It can be used as a model for implementing other pharmacist-managed clinics and~     improving patient medication safety.~   "
82849|NCT01972958|"~     As the aging population increases, preventing and decreasing disabilities become a critical~     issue for the health care system. Previous researches have shown that preventive~     community-based nursing services for older adults could achieve important health benefits at~     a relatively low cost. However, many frail and pre-frail older adults living in communities~     cannot get enough attention from current health care system. The role and function of nurses~     should be expanded to provide more comprehensive family-oriented care to improve health~     outcomes of older adults in Taiwan. The objectives of this study are:~        1. Understand the difficulties and solutions for nurses providing community-based services~          in order to expand their better role and function.~        2. Develop a cultural sensitive community advanced nurse service model for Taiwan in~          health care system.~        3. Explore the effectiveness of community health programs by nurses for frail or pre-frail~          older adults in community.~      Focus groups and literature review will be used to achieve the first and second study~     objectives. A single centre randomized controlled trial will be used in this study to~     achieve the third study objective. Two hundred and twenty people aged 65 and over who meet~     the Fried definition of frailty and pre-frailty will be recruited from the clinic of a~     hospital. Participants will be followed for a 6-month period. Frailty, quality of life,~     satisfaction to the services, hospitalizations and admissions to nursing care facilities~     will be measured and compared between experimental group and control group. This research is~     an important step in the examination of a new approach to the community older people by~     nurses. The study results will provide the evidence data to recommendation for related~     policy making in the future.~   "
82850|NCT01972945|"~     Inserting a telescope into the womb to identify and treat problems with bleeding, pain or~     reproduction is the commonest surgical intervention in gynaecology. This procedure is known~     as a 'hysteroscopy'. The established 'traditional' technique for introducing the~     hysteroscope into the womb involves the use of a 'speculum', which is inserted into the~     vagina. A speculum is the metal or plastic instrument used to stretch and separate the~     vaginal walls so that the opening to the womb, known as the 'cervix' can be seen. The cervix~     is then cleaned and frequently grasped with a sharp toothed forcep to provide traction~     before the hysteroscope is inserted. Whilst hysteroscopy is safe, it is known that pain~     during the procedure can lead to a poor patient experience, and even trigger fainting~     episodes or failure to complete the procedure. As the hysteroscopes have become smaller, it~     has been recognised that it is possible to access the cervix and womb (i.e. 'uterus')~     directly using the hysteroscopic vision without inserting any of these potentially pain~     inducing vaginal instruments. There is however, uncertainty whether this newer technique~     known as 'vaginoscopy' or the 'no touch technique' will minimise the pain experienced by the~     patient or reduce the propensity to fainting. Futhermore, even if vaginoscopy is shown to be~     less painful, the technique may be more prone to failure due to an inability to transverse~     the cervix and enter the uterus without additional instruments. Post-operative infection~     rates of the uterus may also be higher due to vaginal contamination.~      Reducing pain and complications and improving success of the procedure as well as optimising~     patients experience is important because hysteroscopy is an intimate examination, known to~     be associated with significant anxiety and pain. Furthermore, the procedure is widely~     practised representing the most common surgical intervention in day-to-day gynaecological~     practice in the UK and elsewhere. It is therefore important, and timely given that~     outpatient hysteroscopy is increasing especially in community settings, that a large, high~     quality randomised controlled trial comparing 'vaginoscopy' and the 'traditional'~     hysteroscopy is undertaken to resolve the uncertainty as to whether vaginoscopy is less~     painful, safe and more successful than existing approaches to hysteroscopy.~   "
82851|NCT01972932|"~     Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI)~     are the most common causes of healthcare associated infectious diarrhea. In light of the~     results obtained in a limited number of randomized clinical trials in subjects with AAD and~     CDI in comparison with the widespread occurrence of these diseases, it is felt that the~     addition of a well-controlled clinical trial in a western environment would add value to~     support the use of a specific probiotic to counteract these diseases.~   "
82852|NCT01972919|"~     This research study is for people who have pancreas cancer for which surgery is not~     recommended. Potential patients must have already received several months of chemotherapy~     before they are eligible for this study and there will not have been any detectable spread~     of their tumor on imaging studies following this chemotherapy course.~   "
82853|NCT01972906|"~     Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the~     effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized~     controlled trial. 152 participants will be included. Two arms: moxibustion treatment group~     and ibuprofen control group.~   "
82854|NCT01972893|"~     ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic~     cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).~      ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human~     (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ZYD1 in normal healthy adult volunteers.~   "
82855|NCT01972880|"~     To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a~     two-way crossover method in non-elderly healthy male subjects. In addition, the safety of~     these products will be assessed.~   "
82856|NCT01972867|"~     The purpose of this study is to evaluate the feasibility and short-term safety and~     effectiveness of the NanoKnife™ System when used to ablate localized prostate cancer in low~     risk subjects with organ-confined prostate cancer and a low risk of recurrence. This study~     will evaluate the feasibility of the NanoKnife™ System as a focal therapy.~   "
82857|NCT01972854|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
82859|NCT01972828|"~     Haemodynamic optimization is of paramount importance in septic shock, but is really~     consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment~     including fluid loading management, vasoactive treatment and oxygen transport optimization~     is mainly based on expert recommendations or non-randomized trials. Recently, preload~     dependence indexes such as pulse pressure variation have been shown to be more accurate to~     predict fluid responsiveness than static indexes such as filling pressures. However, whether~     using preload dependence indexes changes septic shock prognostic remains to date unknown.~     The aim of this non-blinded randomized controlled trial is to assess whether haemodynamic~     optimization using preload dependence indexes and pulmonary thermodilution 1. reduces septic~     shock duration assessed by administration duration of vasoactive treatment (primary end~     point), 2. reduces regional hypoperfusion assessed by arterial lactate, 3. reduces lung~     hydrostatic oedema linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and~     extravascular lung water). 4. reduces organ dysfunction (assessed by the SOFA score), ICU~     stay and 7 and 28 day mortality Control group is managed with an algorithm using filling~     pressures to drive haemodynamic treatment.~   "
82860|NCT01972815|"~     Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians~     but occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high~     among individuals with a family history of this disease, but no specific genetic factors~     have been identified that can serve to guide clinical management of this high-risk~     population to ensure early detection and treatment of this life-threatening condition.~   "
82861|NCT01972802|"~     Our overall objective is to understand the role of lifestyle factors, genetics and HPV~     infection in the development and prognosis of head and neck cancer particularly in Asia.~   "
82862|NCT01972789|"~     To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by~     the definition of disease activity which determines the treatment interval until the next~     injection. The results will be used to generate further recommendations about intensive~     versus relaxed treatment approaches and how they can be utilised within an 'inject and~     extend' approach to maximise patient outcomes, while reducing the need for potentially~     unnecessary intravitreal injections. This study will also investigate genotypic expression~     and response to intravitreal injections of ranibizumab between the two treatment arms.~      The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF only~     results in visual acuity benefit that is not clinically worse than intravitreal ranibizumab~     when administered to completely resolve both IRF and SRF in patients with wet AMD.~   "
82863|NCT01972776|"~     This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD~     patients. Part 2 was an efficacy study in GOLD I-III COPD patients.~   "
82864|NCT01972763|"~     The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg~     in subjects who were previously treated with Bevacizumab and subsequently switched to~     Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the~     previous therapies; therefore, the study aims to see if Ranibizumab may have a greater~     treatment effect.~   "
82865|NCT01972750|"~     In this study with a modified 3+3 dose finding design, a safe and tolerable dose of TKI258~     in patients with relapsed glioblastoma should be established.~   "
82866|NCT01972737|"~     The purpose of this study is to determine the safety, tolerability and ability to stimulate~     hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in~     stage I and stage II Caucasian and African American colon cancer patients.~   "
82867|NCT01972724|"~     The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic~     control as when used in patients with inadequately controlled type 2 diabetes mellitus~     treated with fixed combinations of metformin and sulfonylurea.~   "
82868|NCT01972711|"~     This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy~     male and female volunteers with high or low schizotype characteristics.~   "
82869|NCT01972698|"~     The purpose of this study is to determine whether a self-directed and simulation-based lung~     ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on~     anesthesia trainees' image acquisition skills and diagnostic acumen. The investigators~     hypothesize that a self-directed and ultrasound-assisted LUS and FCU curriculum that~     includes video lectures, online teaching modules, an ultrasound simulator, and self-directed~     hands-on sessions on critically ill mechanically ventilated patients is effective in~     training novice ultrasonographers to obtain good quality images, to correctly interpret~     them, and to support clinical decision-making in critically ill patients.~      Trainees will be randomized to fully supervised FCU hands-on sessions on healthy models and~     critically ill mechanically ventilated patients (control group - traditional apprenticeship~     model) or to a completely self-directed and simulation-based approach (intervention group).~      To assess if this new self-directed and simulation-based ultrasound curriculum leads to~     adequate acquisition of competences (adequate image acquisition and interpretation) in~     novice ultrasonographers, trainees will have to perform a focused lung and cardiac~     assessment on a critically ill mechanically ventilated patient.~   "
82870|NCT01972685|"~     The objective of this study is to compare the sample size, architectural preservation and~     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) to~     bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic~     Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).~   "
82871|NCT01972672|"~     The primary objective of the study is to assess the time to progression (TTP) in patients~     with advanced HCC treated with Icaritin .~   "
82882|NCT01972529|"~     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group~     study using avatrombopag to treat adults with thrombocytopenia associated with liver~     disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia~     associated with liver disease prior to an elective procedure to reduce the need for platelet~     transfusions or any rescue procedure for bleeding due to procedural and post-procedural~     bleeding complications. Participants will be enrolled into 2 cohorts according to mean~     baseline platelet count and, within each baseline platelet count cohort will be further~     stratified by risk of bleeding associated with the elective procedure (low, moderate, or~     high) and hepatocellular carcinoma (HCC) status (Yes or No).~   "
82872|NCT01972659|"~     Background: The aim of this prospective study was to evaluate the effect of magnesium on the~     reversal of rocuronium-induced neuromuscular block by sugammadex.~      Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II,~     undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with~     propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane.~     The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a~     bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo~     group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg~     rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached~     1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg~     sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was~     achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.~   "
82873|NCT01972646|"~     Introduction: Despite several expert panel recommendations and cellulitis treatment~     guidelines, there are currently no clinical decision rules to assist clinicians in deciding~     which emergency department (ED) patients should be treated with oral antibiotics and which~     patients require intravenous therapy at first presentation of uncomplicated cellulitis. The~     objective of this prospective study is to determine potential patient risk factors~     associated with adult patients (>17years) presenting to the ED with a concern about a skin~     or soft tissue infection who fail initial antibiotic therapy for the treatment of standard~     cellulitis and require a change of antibiotics or admission to hospital.~      Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients~     will be excluded if they have been treated with antibiotics for the current bout of~     cellulitis prior to presenting to the ED, patients admitted to hospital and those patients~     with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the~     initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined~     as patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if~     oral antibiotics were prescribed initially), or a change of oral antibiotics for the~     original cellulitis.~      Results: This study will provide a detailed profile of patient risk factors associated with~     treatment failure of cellulitis. The results will be analyzed and used in formulating a~     clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of~     the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate~     analysis will be considered in a multivariate logistic regression model. Additionally,~     treatment variability among clinicians in regard to cellulitis will be evaluated and~     compared to treatment failures, thus providing data on successful treatment regimens.~      Conclusions: Results from this research may be used to generate a clinical prediction rule~     to assist clinicians in effectively treating patients presenting to emergency departments~     with cellulitis. Understanding which patient risk factors for treatment failure will assist~     clinicians in determining which patients will benefit from intravenous versus oral~     antibiotics.~   "
82874|NCT01972633|"~     There is a difference concerning obliteration rate and postoperative pain after treatment of~     the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .~   "
82875|NCT01972620|"~     Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients~     undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical~     cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after~     laparoscopic cholecystectomy.~   "
82876|NCT01972607|"~     This study has been designed in order to know the effect of 12 weeks of aerobic exercise~     training for migraine prevention. We hypothesized that the exercise training could reduce~     the number of days with migraine and the number of attacks per month in the treated group.~   "
82877|NCT01972594|"~     Total hip replacement is designed to alleviate pain, reduce disability and improve function~     and physical activity levels. Whilst pain, disability and function are often measured~     following surgery, actual physical activity is not. The aim of rehabilitation after total~     hip replacement would be to obtain optimal strength and range of movement at the hip along~     with cumulative endurance and balance. It is taken for granted that, once function is~     restored, the patient returns to physical activity levels associated with good health. In a~     previous study conducted by the same team it was observed that patients, at the end of 3~     months after hip surgery, do not reach the levels of physical activity which are proven to~     be beneficial for health. Physiotherapy plays an important role in improving function and~     increasing levels of Physical activity in total hip replacement patients, but there is~     limited literature to substantiate this claim. There is a need to enhance levels of physical~     activity in patient after total hip replacement towards levels that are associated with good~     health. This study aims to demonstrate a method of enhancing physical activity levels after~     total hip replacement using a pedometer based intervention over a period of 3 months.~     Patients will follow a customized progressive stepping activity schedule aimed at~     establishing levels of physical activity that are associated with good health. To fully~     understand recovery patterns subjective and objective measures of strength of the hip~     muscles, range of motion at the hip, overall endurance, balance and speed of walking of the~     patient will be assessed. Questionnaires will be utilized to assess quality of life both~     before and after total hip surgery. The physical activity levels of the patient will be~     measured with a physical activity monitor. This study will be completed at the Golden~     Jubilee National Hospital at Glasgow.~   "
82878|NCT01972581|"~     Incorporating neurocognitive visual reaction training has been shown to increase bating~     performance in collegiate baseball players. However, poor methodology, such as lack of a~     control group and use of an unreliable outcome measure, limit the strength of the previous~     study. Therefore the purpose of this study is to determine the effects of neurocognitive~     visual reaction training on reaction time and coordination in an athletic population.~      The purpose of this study is to determine the effects of neurocognitive visual reaction~     training on reaction time and coordination.~   "
82879|NCT01972568|"~     This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of~     atacicept in subjects with systemic lupus erythematosus (SLE).~   "
82880|NCT01972555|"~     This is a single-center, open-label, randomized controlled trial. Patients scheduled for~     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will~     be eligible. Forty patients will be randomly assigned to either minimally invasive (20~     patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and~     bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be~     implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4,~     and 40. Echocardiographic parameters as well as preoperative clinical characteristics and~     postoperative clinical outcomes will be registered. Routine blood sampling will be performed~     pre- and postoperatively. All available data will be collected prospectively. Informed~     consent will be obtained from patients meeting the inclusion criteria before the initiation~     of any study-specific procedures.~   "
82881|NCT01972542|"~     The hypertriglyceridemia at fasting status has been known to be an important risk factor for~     cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an~     attention as a superior predictor of CVD because of non-fasting state for more than 12 hours~     and importance of triglyceride-rich lipoprotein.~      We aim to investigate the relationship of postprandial triglyceride after fat tolerance test~     and intima-medial thickness and to suggest normal reference of postprandial triglyceride~     after fat tolerance test. In addition, we evaluate the correlation of postprandial~     triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate~     clinical importance of postprandial triglyceride in assessment of cardiovascular risk.~   "
82891|NCT01972412|"~     The purpose of this study is to determine whether phone use contributes to diabetes control.~   "
82883|NCT01972516|"~     This research study is evaluating a drug called tivozanib as a possible treatment for~     ovarian, fallopian tube or primary peritoneal cancer.~      Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and~     spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a~     tumor's blood supply so that it does not get the blood and nutrients it needs to grow.~      In this research study, the Investigators are looking to see whether tivozanib works as a~     maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in~     participants who have achieved a complete response following chemotherapy. Maintenance~     therapy is given after a disease has responded to previous treatment. It is given to help~     prevent the spread or recurrence of the tumor.~   "
82884|NCT01972503|"~     In this study, the investigators assessed whether intraoperative Intraportal infusion of~     5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative~     colorectal cancer resection.~   "
82885|NCT01972490|"~     In this study, the investigators assessed the effect of avastin in combination with~     chemotherapy in the treatment of unresectable metastatic colorectal cancer.~   "
82886|NCT01972477|"~     This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind~     clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449~     in elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis~     of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol~     level from baseline to the end of study significantly higher than the elevation resulted by~     placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will~     provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).~   "
82887|NCT01972464|"~     Smoking is the main preventable cause of mortality in Western countries, contributing to~     over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that~     women often decrease smoking in pregnancy, when progesterone levels are high. However, at~     least half resume pre-pregnancy smoking levels within weeks after delivery and when~     progesterone levels drop.~      Data from preclinical and clinical studies suggest that progesterone may be effective in~     preventing relapse to smoking in non-postpartum women. Prior work has shown that~     progesterone decreases both craving for cigarettes and the subjective rewarding effects of~     smoking among recently abstinent female smokers. These findings led us to hypothesize that~     progesterone may have efficacy as a relapse prevention treatment for postpartum women.~      We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of~     progesterone. This will be a feasibility study that will compare progesterone to placebo for~     relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety,~     including the potential effects on breastfeeding and infants exposed via breast milk, in~     addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at~     follow-up, 3-months after the end of the protocol.~   "
82888|NCT01972451|"~     The Bowel Cancer Screening program was implemented to address the important issue of~     prevention and early detection of bowel cancer. Results from the first few years of~     screening and previous smaller studies show that while in its current form it will save many~     lives, there continue to be polyps and cancers in the upper large bowel (right side) that~     may be difficult to detect. There is some evidence that these types of polyps (serrated~     polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and~     have a faster rate of growth to cancer compared to conventional polyps (adenomas). We~     propose to examine participants undergoing screening colonoscopy with the addition of a~     contrast dye ( a safe food colouring agent base already used in various bowel camera~     procedures in standard clinical practice). This has been shown to improve detection of~     conventional polyps significantly even though it is considered by some to be more time~     consuming (possibly taking a few minutes longer) and requiring specific training to~     undertake. We hope to study the feasibility of undertaking these procedures to improve~     detection and removal of these polyps within the bowel screening program and potentially~     inform further studies to assess the impact of improved detection and consequent potentially~     reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the~     main aims of this feasibility study are to assess if this type of procedure would be~     feasible to implement and acceptable to participants, colonoscopists and the screening~     program and also assess any additional time or costs involved to inform the question of if a~     larger study should then be undertaken to conclusively prove or disprove the merits of this~     approach in terms of health economics, cancer detection and survival.~   "
82889|NCT01972438|"~     Some eye diseases can be helped by eye drops made from a person's own blood. These eye drops~     are called autologous serum eye drops, or ASEDs. ASEDs have been studied in only a few~     people with graft vs. host disease (GVHD) affecting the eye and were found to be helpful~     with few side effects.~      The purpose of this study was to determine whether ASEDs are safe and more effective than~     control (normal saline) and can help with eye symptoms in people with severe chronic eye~     GVHD.~      Each participant in this study was to have blood drawn to prepare ASEDs specifically for the~     participant. Each participant was scheduled to receive ASEDs for 3 months and placebo eye~     drops (salt water) for 3 months. Participants did not know when they were receiving the~     ASEDs and when they were receiving placebo eye drops.~   "
82890|NCT01972425|"~     Critically ill patients whose lungs are supported by breathing machines (ventilators)~     commonly develop a new lung infection, called ventilator-associated pneumonia (VAP). Because~     VAP is often fatal, antibiotics are administered whenever it is suspected. However VAP is~     hard to distinguish from several non-infective lung conditions and most patients with~     suspected VAP do not have pneumonia. Therefore many patients receive unnecessary antibiotics~     for several days, promoting emergence of 'superbugs'. Laboratory test results for diagnosing~     VAP typically only reach the doctors after 3 days.~      A simple test rapidly and confidently excluding VAP should improve patient care, reduce~     unnecessary antibiotics and decrease costs. We recently showed that low levels of specific~     proteins in fluid from the lungs of patients with suspected VAP effectively excluded VAP,~     using a test that may yield results within 6 hours. The test used is an extension of~     existing technology produced by our commercial partner Becton Dickinson (BD) Biosciences.~      Our previous findings were derived from a single hospital's intensive care unit. We have~     recently confirmed this finding across many intensive care units, which will help show that~     the test can be used in 'real life'. The aim of this study is to take the new test to the~     next step and determine whether it can improve the care of patients by reducing the amount~     of unnecessary antibiotics prescribed. This will be done using a 'randomised controlled~     trial', the best tool for scientifically testing a new diagnostic test. To do this we shall~     identify patients with suspected VAP, all of whom will have a lung sample - half of the~     patients will receive 'usual care' for suspected VAP, the other half will have the new test~     performed on their lung fluid. If the new test suggests no lung infection, the doctors will~     be asked to consider not giving antibiotics. We shall test how much antibiotic is given to~     each group.~   "
82894|NCT01972373|"~     To improve rectal cancer management, there is a need for better visualization of drug~     targets in rectal cancer to identify patients who might benefit from specific targeted~     treatments. Molecular imaging of rectal cancer associated targets is a promising technique~     to accommodate this need. Vascular Endothelial Growth Factor (VEGF), which is differentially~     expressed in normal versus malignant colon tissue, has proven to be a valid target for~     molecular imaging. Fluorescent labeling of bevacizumab (a VEGF targeting humanized~     monoclonal antibody currently used in anti-cancer therapy) using IRDye800CW (a fluorescent~     dye) has potential advantages in view of safety, infrastructure, costs, stability and~     imaging resolution. Therefore, the fluorescent tracer bevacizumab-IRDye800CW has been~     developed at the University Medical Center Groningen (UMCG) and was recently approved to be~     administered to patients in a tracer dose. To detect this tracer in vivo in patients with~     colorectal cancer, a newly developed flexible near-infrared (NIR) fluorescence endoscope and~     optoacoustic endoscope have been developed which can be used in clinical studies. Optical~     fluorescence imaging may support response evaluation following chemoradiotherapy and give~     insight which patient might benefit from anti-VEGF targeted therapy in future studies.~   "
82895|NCT01972360|"~     SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well~     as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing~     the use of non-isotope based imaging modalities has the potential to change the standard of~     care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography)~     has its own distinct potential advantages over SPECT.~   "
82896|NCT01972347|"~     This is an open label, single centre, phase II study of neoadjuvant drug treatment with~     dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer~     (AJCC) Stage IIIB-C BRAF V600 mutation positive melanoma.~      The main aim of this study is to find out if giving of a new combined drug treatment to~     patients with melanoma that has spread to the lymph nodes BEFORE they have surgery, will~     result in improved clinical and pathological response of the melanoma tissue after 12 weeks~     treatment.~   "
82897|NCT01972334|"~     The incidence of C. difficile infection (CDI) has alarmingly increased over the past several~     years and the affected population has expanded to include those previously at low risk, such~     as children. The annual US financial burden associated with this infection is great and~     estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial~     ecology is disrupted during interventions notorious for perturbing the delicate microbial~     balance. A well known and common example is the use of antibiotics. Fecal microbiota~     transplant (FMT) has been introduced several decades ago in an attempt to restore the gut~     microbial balance. To this date there have been a great number of reports of success in~     eliminating recurrent C. difficile infections and restoring the gut microbial profile to~     resemble that of the healthy donor. While over 300 cases have been described in the~     literature, there has been no pediatric controlled studies performed to compare its efficacy~     to placebo. Therefore, there is a strong need to determine their safety and efficacy in~     pediatric randomized controlled studies. The investigators hypothesize that children with~     recurrent C. difficile infection will respond to fecal transplant therapy which will modify~     their gut microbial profile. The investigators propose a randomized, placebo controlled,~     pilot study of fecal microbial transplant in children with recurrent C. difficile infection~     to evaluate the safety and efficacy of fecal microbial transplant in children in preventing~     recurrent C. difficile infection. The investigators anticipate that fecal microbial~     transplant in children with recurrent C. difficile infection will be safe and efficacious~     and will provide these children with a great alternative to a disease that is difficult to~     treat. Results of this study will establish the major role of the gut microbiome in this~     disease and demonstrate the viability of gut microbial transplant in recipients.~   "
82898|NCT01972321|"~     The aim of the inSCALE project is to test the effect of innovative approaches to increase~     coverage of integrated community case management, which provides community based-care for~     diarrhoea, pneumonia and malaria, resulting in more children receiving timely and~     appropriate care for these three most common childhood illnesses~   "
82899|NCT01972308|"~     Few interventions to improve asthma management have targeted low-income minority asthmatic~     adults and even fewer have focused on the real-world practice where care is provided for~     these patients. This project tests the effectiveness of a Patient Advocate as a practical~     and sustainable method of facilitating and maintaining communication between patient and~     provider and access to chronic care for adults with moderate or severe asthma recruited from~     clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to~     current asthma care and test the Patient Advocate's cost-effectiveness.~   "
82900|NCT01972295|"~     This is an observational, prospective, non-randomized, multicenter study with the following~     objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial~     Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a~     commercial clinical setting and (2) to collect health care usage data that may be needed for~     reimbursement of WATCHMAN technology in certain countries.~   "
82901|NCT01972282|"~     The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may~     form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic~     thromboembolism. The objectives of this observational, prospective, non-randomized~     multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA~     (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN~     device in a commercial clinical setting and (2) to collect real-world usage data that may be~     needed for reimbursement of WATCHMAN technology in certain countries.~   "
82902|NCT01972269|"~     Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of~     the most commonly used drugs for that purpose. The efficacy of a certain medication injected~     epidurally depends on the dose that is given. A certain dose can be administered in~     different concentrations, which will consequently mean different volumes. Studies have been~     done to determine volumes for different concentrations of bupivacaine. However, those~     studies fall short in the sense that this information cannot be readily applicable in~     clinical practice, as we don't use bupivacaine plain. The combination of bupivacaine and~     fentanyl or sufentanil is common practice, as it is well established that the opioids will~     reduce the concentration of local anesthetic required to produce optimal effect with the~     least side effects.~      This study is being planned to determine and compare the EV90 of the bupivacaine~     0.125%-fentanyl mixture for initiation of labor epidural analgesia, following the~     administration of the 2 different test doses (3cc of lidocaine 2% or 3cc of the bupivacaine~     0.125%-fentanyl mixture) used in our Department.~   "
82936|NCT01971827|"~     Coordinated project whose objectives are: a) to test the effectiveness of a promotion of~     physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the~     academic performance in both children with and without attention deficit hyperactivity~     disorder (ADHD)~   "
82903|NCT01972256|"~     The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion~     procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or~     bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to~     transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or~     bilateral supplemental screw fixation as an adjunct to fusion.~      Subject candidates are those who had previously required and received fusion at L4-L5-S1~     where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis,~     spondylolisthesis, or degenerative disc disease (DDD).~   "
82904|NCT01972243|"~     Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite~     anticoagulation is recommended, but confers a considerable bleeding risk. It is important to~     identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and~     who will not benefit from long term anticoagulation. By use of a scoring model (Vienna~     Prediction Model), patients can be stratified according to their recurrence risk based on~     their sex, location of VTE and D-Dimer. Before implementation in routine care, an~     independent validation is required. Patients with unprovoked VTE will stop anticoagulation~     after 3-7 months and the recurrence risk will be estimated by use of the Vienna Prediction~     Model. Low risk patients with a score of <180 will be included and will be left untreated.~     Patients with a high score will not be included and their management will follow current~     guidelines. Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.~   "
82905|NCT01972230|"~     This study aimed to evaluate the possible protective effect of anesthetic technique balanced~     (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion~     injury in microvascular flap in plastic surgery. The investigators will evaluate the~     viability of the flap using tissue oximetry monitoring and the level of biochemical markers~     in a circle at the end of the intervention.~   "
82906|NCT01972217|"~     This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety~     run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when~     given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind,~     placebo controlled comparison of the efficacy, safety and tolerability of the dose of~     olaparib selected from Part A when given in addition to abiraterone, versus placebo given in~     addition to abiraterone. Abiraterone is indicated in combination with prednisone or~     prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone~     5 mg twice daily (bid) will be administered with the abiraterone in this study.~   "
82907|NCT01972204|"~     The purpose of this study is to examine the influence of the instruction on the use of~     Aricept with educational brochure on the 48-week medication persistence and to assess the~     reasons for discontinuation.~   "
82908|NCT01972191|"~     Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is~     important. Due to new corneal topographic method, iTrace™ surgical workstation, precise~     evaluation of corneal horizontal marking is available. In this study the investigators~     compared three known corneal horizontal making techniques and evaluate accuracy of each~     methods using iTrace™.~   "
82909|NCT01972178|"~     The objective of this study is~        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood~          lipids and lipoprotein parameter from baseline after 12 weeks of treatment~        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety~          parameters~   "
82910|NCT01972165|"~     A few studies have shown that the mini-incision release technique decreases the pathologic~     swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening~     ratio of the median nerve in the carpal tunnel. However, it is unknown whether the~     endoscopic release technique similarly reverses these pathological changes in the median~     nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.~      Investigators therefore conducted the current study to compare the subjective outcomes and~     US-measured morphological changes in the median nerve in patients with CTS who received~     either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective~     outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function~     scores and the DASH scores, would be similar 24 weeks after either mini-incision or~     endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each~     level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks~     after either mini-incision or endoscopic carpal tunnel release; and (3) morphological~     changes would be correlated with improvements in subjective outcomes 24 weeks after~     mini-incision or endoscopic carpal tunnel release.~   "
82911|NCT01972152|"~     The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly~     Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a~     complication of diabetes.~   "
82912|NCT01972139|"~     An international, multi-center, prospective, blinded, randomized, controlled trial. The~     objective is to demonstrate that catheter-based renal denervation is an effective and safe~     treatment for uncontrolled hypertension.~   "
82913|NCT01972126|"~     The MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD~     Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left~     ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination~     with parameters derived from a Holter recording can be used to identify a group of patients~     at high risk for SCD/life threatening ventricular arrhythmia.~   "
82914|NCT01972113|"~     The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and~     matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular~     disease (at least in mouse models). Clinical trials are needed to isolate the effects of~     vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA~     protein) and their subsequent effects on markers of diabetes and cardiovascular disease~     risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in~     children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to~     improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have~     an effect on markers associated with diabetes and cardiovascular disease risk.~   "
82915|NCT01972100|"~     The study hypothesis is a improved muscle fatigue resistance induced by low-level laser~     therapy applied between sets of intense exercises.~   "
82916|NCT01972087|"~     This study is to test the use of simulation training to improve 9-1-1 telecommunicators'~     call processing and response. Training sessions will expose 9-1-1 telecommunicators to~     several realistic emergency situations through mock 9-1-1 calls with a trained actor playing~     the part of a reporting party, followed immediately by feedback on call handling provided by~     a trained call observer. Investigators hypothesize that simulation followed by trained~     observer-directed feedback will increase correct triage of medical emergency and delivery of~     pre-arrival instructions during simulated calls and in actual 9-1-1 calls.~   "
82917|NCT01972074|"~     This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for~     the treatment for social impairment in adolescents with autism spectrum disorder (ASD). The~     investigators will also conduct pre- and post-treatment neuroimaging (fMRI and HMRS) to~     assess neural functional deficits in adolescents with ASD compared to healthy volunteer~     adolescents and to assess any effects of memantine therapy on neural function in adolescents~     with ASD. The investigators hypothesize that short-term memantine monotherapy will be safe,~     well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in~     adolescents with ASD. Additionally, the investigators hypothesize that following memantine~     therapy, ASD subjects will exhibit a decrease in glutamate (Glu) concentration in the~     anterior-cingulate cortex (ACC) and a change towards normalization in altered functional~     connectivity of the ACC and medial temporal lobes, consistent with improvement in social~     impairments in ASD. The investigators hypothesize that compared to healthy volunteer~     subjects, ASD subjects will significantly differ on neuroimaging measures at baseline but~     that following memantine therapy, the difference between ASD and healthy volunteer~     neuroimaging data will decrease.~   "
82918|NCT01972061|"~     The purpose of this study is to determine if electrical stimulation of the foot is effective~     in the treatment of overactive bladder conditions.~   "
82919|NCT01972048|"~     Korean American (KA) women have among the highest breast cancer mortality rates and lowest~     breast cancer screening rates of U.S. American women across racial/ethical groups. This~     innovative project seeks to harness mobile phone technology as a means to take preventative~     health care to a new level among this population. Using the Fogg Behavioral Model this study~     proposes to develop a mobile phone-based intervention designed to motivate KA women to~     undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the~     feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade~     KA women to undergo breast cancer screening.~   "
82920|NCT01972035|"~     Our study will compare all kidney transplant recipients receiving valganciclovir vs.~     valacyclovir for one year following kidney transplant and compare:~        1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after~          transplant.~        2. the side effects of the anti-viral drugs requiring dose reduction or cessation~      In addition, we will test renal tissue obtained from any biopsies post-transplant~     (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and~     fluorescence in situ hybridization to assess for latent CMV and/or EBV.~   "
82921|NCT01972022|"~     First prospective randomized controlled study to evaluate in an 'all-comers' population with~     coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a~     biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with~     respect to the long term vascular response to treatment These data are important to~     ascertain the superiority of a new generation DES with bioabsorbable polymer coating to~     reduce the long term development of in-stent neoatherosclerosis.~   "
82922|NCT01972009|"~     The mechanism governing how blood flows from the heart to the lungs depends on many factors~     including the pumping function of the right ventricle, properties of the arteries that carry~     the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs~     themselves.~      Under normal conditions the pressure in the pulmonary arteries is well controlled and~     significantly lower than in the systemic circulation, however there are a number of~     conditions that lead to abnormally high pressures and significant morbidity and mortality.~      However different patients respond differently to similarly elevated pressures, leading~     doctors to believe that there must be differences in either the right ventricles, the~     properties of the arteries, or the lungs themselves. It can be difficult to determine the~     relative contributions of each of these factors on blood flow because their effects are~     superimposed on each other.~      One approach that has been used to look at this in other parts of the circulation (including~     in the systemic circulation and the coronary arteries) is to measure simultaneous pressure~     and flow, and apply a technique called wave intensity analysis (WIA). This technique can~     amongst other things, quantify the separate effects of wave reflection and the 'reservoir~     function' (or compliance) of the arteries, and in the systemic circulation WIA has increased~     the understanding of the mechanisms behind hypertension and the physiological changes of~     ageing. The pulmonary arteries are accepted to be very different from the systemic~     circulation and the mechanisms behind pulmonary hypertension are thought to be very~     different to those of systemic hypertension.~      This protocol aims to determine the major influences on blood flow in the pulmonary arteries~     in health and disease, to help to understand why some patients are affected more than others~     by elevated pulmonary pressures.~   "
82923|NCT01971996|"~     During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS~     technology can be used. It consist of two sensors placed on the forehead, and measures the~     oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery~     placed in the prone position, the NIRS measurement will be affected, because the weight of~     the head will produce a pressure on the sensors. We wish to investigate how much the~     measurement is affected. Furthermore we plan to lift the head to remove the pressure, and~     record the time needed for the measurements to return to baseline.~   "
82924|NCT01971983|"~     The objective of this randomized controlled trial is to describe the effect of two~     osteopathic techniques - high velocity, low amplitude (HVLA) and muscle energy (ME) - on~     thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles~     at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day~     follow-up.~      The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal~     oblique, external oblique and transversus abdominis can be altered after the application of~     'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after~     a two-day follow-up.~   "
82937|NCT01971814|"~     The aim of this study is to a.) evaluate whether early serum infliximab levels are~     predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate~     with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are~     inversely correlated with serum infliximab levels.~      In patients hospitalized for severe ulcerative colitis and treated with high-dose~     infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be~     positively associated with clinical response and avoidance of colectomy.~   "
88948|NCT01893008|"~     The PREPARE study is the first multicenter randomized controlled trial to evaluate the~     hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary~     complications in patients undergoing esophageal resection.~   "
82925|NCT01971970|"~     Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for~     refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction~     (primary response) and maintenance of remission. When effective, clinical and endoscopic~     remission is reached within weeks. However, primary non-response is observed in 20% of~     pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response~     to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80%~     of patients have secondary loss of response, necessitating dose adjustments to maintain~     clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC),~     and has been shown to induce remission in active disease. For UC, the comparison between the~     efficacy in children versus adults is more difficult to report as studies in children are~     scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects,~     infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to~     early identify non-responders to treatment, and therefore it is important to develop~     predictive biomarkers of treatment response.~   "
82926|NCT01971957|"~     Sjogren-Larsson syndrome (SLS) is a rare genetic disease in which patients typically exhibit~     ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a~     distinctive maculopathy. The purpose of this study is to define the clinical spectrum and~     natural history of Sjogren-Larsson syndrome, and identify biomarkers that correlate with~     disease phenotype while establishing a registry for future investigations of biochemical~     pathogenesis and therapy.~   "
82927|NCT01971944|"~     Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized~     patients who are receiving Beta Blocker Participants: Patients who are admitted to the~     General Cardiology and Heart Failure Services at the University of North Carolina Hospitals~     with acute decompensated heart failure, who have maintained steady state concentrations of~     beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team~     to require pulmonary artery catheter placement and inotropic therapy with dobutamine or~     milrinone by continuous infusion. Patients that are not currently receiving beta blocker~     therapy will be enrolled for comparative purposes; however, any patient not at steady state~     (on or off beta blocker therapy) will not be enrolled.~      Procedures: After obtaining informed consent, patients will be assigned to the appropriate~     sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol~     and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine~     followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm~     attached, as part of the usual standard of practice). Baseline pulmonary artery catheter~     hemodynamic parameters will be collected prior to administration of inotrope trial of~     dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing~     algorithm following initiation and dose titration. Dose titration will be determined by the~     health care team based upon patient response or lack thereof and tolerability. Changes in~     hemodynamic parameters in response to dobutamine or milrinone will be compared within study~     groups. Additionally, data will continue to be collected on patients receiving not beta~     blocker therapy for comparative purpose.~   "
82928|NCT01971931|"~     Bone quality is an important factor influencing the outcome of total knee replacement (TKR)~     surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the~     choice of the most appropriate prosthetic implant.~      The primary goal of this study is to measure serum and tissue levels of some proteins~     involved in bone remodelling.~   "
82929|NCT01971918|"~     The objective of the study is to evaluate two therapeutic strategies: early switch or~     therapeutic intensification in patients with spondyloarthritis in case of secondary~     treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase~     of ASDAS and positivity to ADAb.~      Patients and Methods:~      Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of~     follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or~     adalimumab will be included if their ADAb dosage is positive, and they will be randomized~     (1:1) in two groups : early switch where treatment will be change to another anti-TNF, or~     therapeutic intensification where interval between two injections will be shortened.~     Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24~     weeks. Principal outcome will be the variation of ASDAS between baseline and end of the~     study. Number of patients to be included has been determined statistically from a~     preliminary study (power >98% for ASDAS variation of 20% on week 24).~      Expected results:~      On week 24, we expect a better response and a greater proportion of patients in remission in~     the early switch arm compare to the therapeutic intensification arm.~   "
82930|NCT01971905|"~     To investigate the ability of perfusion CT/US-scanning to facilitate recognition of~     different tumour sub-types in small renal masses less than 7 cm by non-invasive imagining~     technology.~   "
82931|NCT01971892|"~     Acute respiratory failure may occur early in the postoperative course, requiring~     endotracheal intubation and mechanical ventilation in selected patients, thus increasing~     morbidity and mortality and prolonging intensive care unit (ICU) and hospital stay.We will~     perform a multicenter, prospective, randomized clinical trial to compare the efficacy of non~     invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15~     cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen~     therapy in the treatment of postoperative acute respiratory failure. We also set out to~     examine the hypothesis that early application of NIV may prevent intubation and mechanical~     ventilation in patients who develop acute respiratory failure after abdominal surgery.~   "
82932|NCT01971879|"~     Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be~     explored twice through a Cross-over strategy to determine whether remote preconditioning~     improves arteritic patients' ability to walk.~   "
82933|NCT01971866|"~     This study aims to investigate the advantages of using AlignRT, a commercially available,~     FDA approved camera-based imaging system for proton therapy patients prior to and during~     their radiation treatment delivery.~   "
82934|NCT01971853|"~     All healthcare providers strive continually to improve the outcome of their treatment~     approaches. The investigators hypothesize that preventive analgesics administered before a~     child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.~   "
82938|NCT01971801|"~     Urinary incontinence (UI) is a common disorder among older women that greatly affects~     quality of life. Emerging evidence from observational studies links vitamin D insufficiency~     with UI. Prior to a larger intervention trial of vitamin D among older women with low serum~     vitamin D levels and urgency UI, we propose a pilot study in 100 older women comparing~     weekly, oral vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D~     supplementation will improve UI symptoms in older women with vitamin D deficiency. Changes~     in UI-episodes will be assessed by a 7-day bladder diary and other validated symptom~     measures administered at baseline and after 12-weeks of intervention. Serum calcium and~     25(OH)D levels will be monitored. The expected outcomes will provide new knowledge regarding~     the impact of vitamin D supplementation on UI symptom improvement and inform a larger,~     randomized controlled clinical trial involving vitamin D supplementation.~   "
82939|NCT01971788|"~     Residual thrombosis of stent struts may occur after the end of primary angioplasty and~     determine distal embolization and further myocardial damage. Bivalirudin is considered the~     most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase~     in stent thrombosis has been reported. In order to overcome this potential adverse event, a~     prolonged infusion of bivalirudin after the end of PCI has been proposed.~      This aim of this study is to test whether the use of long-term bivalirudin infusion, as~     compared to the intra-procedural only administration, reduces residual thrombosis of stent~     struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5~     days follow-up.~      A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by~     TRansradial access site and AngioX study) study will be selected showing the following~     inclusion criteria:~        -  patients affected by STEMI undergoing primary PCI with stent implantation and~          randomised to bivalirudin treatment,~        -  patients who, in addition to the infarct related lesion, show at least one critical~          stenosis of other coronary vessels suitable for staged-PCI,~        -  patients whose anatomy is suitable for OCT evaluation.~   "
82940|NCT01971775|"~     Surgery is the first standard treatment for stomach cancer, but it still has negative~     factors such as bleeding, leakage, closure, surgery part infection and cardiovascular and~     lung complication by general anesthesia.~      electric cautery is used extensively in surgery room due to the utility of simultaneous~     severance and hemostasis. In some case, the electric current from vitality electrode may~     unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears~     (UAS) is a device to transform the protein of organ for organ incision or hemostasis.~     General advantages possibly include shortened operating time, decrease of operative blood~     loss, and relatively less damages to the normal organ. UAS is commonly used in the operation~     room, which is now considered as a secure and useful medical device for for tissue~     dissection and coagulation. Also, it is expected to lower the risk of surgery by reducing~     operating time and blood loss.~      However, clinical evidence is not sufficient for this device until now. Therefore, in this~     study,~        1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open~          gastrectomy~        2. Would like to compare the following two kinds of energy based devices. A. For~          conventional monopolar electrosurgery group : dissection and sealing will be conducted~          by conventional monopolar electrocautery device B. For UAS group : dissection and~          sealing will be conducted by UAS~   "
82941|NCT01971762|"~     Staphylococcus aureus bacteremia: impact of an intervention program in improving the~     clinical management and review of the clinical and molecular epidemiology.~   "
82942|NCT01971749|"~     Register of treatment of unprotected left main coronary artery stenosis in Andalucia~     (RETRATO).~   "
82943|NCT01971736|"~     We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face~     for skin tightening immediately post laser and 3 months follow up.~   "
82944|NCT01971723|"~     It has been suggested that high amounts of total serum testosterone levels correlate with~     higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These~     suggestions drive athletes and body builders to find ways to raise their testosterone~     levels. Many athletes and bodybuilders look to alternative methods to anabolic steroids in~     order increase their testosterone levels without legal repercussions or physiological side~     effects. Herbs and other plant extracts have been introduced as a possible source to~     naturally boost testosterone levels. Research supporting the use of herbs and plant extracts~     has been shown to be equivocal. However, evidence in studies with hypogonadal men suggests~     that longjack root may naturally boost testosterone levels.~      Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost~     testosterone and lower estrogen levels and subsequently improve performance. This product is~     a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic~     workouts, such as high intensity weight training.~      T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic~     acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta-~     alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.~      The active ingredients purported to boost plasma testosterone levels are mucuna pruriens,~     longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma~     estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other~     ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve~     exercise performance.~      It is hypothesized that there will not be any physiological changes after supplementation of~     T+. It is also hypothesized that performance will not be affected by the supplementation of~     T+.~   "
82945|NCT01971710|"~     The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project~     is to increase community demand for, uptake of, and retention in Maternal and Child Health~     (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve~     country progress toward elimination of pediatric HIV/AIDS.~   "
82946|NCT01971697|"~     This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an~     orthopaedic injury will be approached. If a patient consents to be part of the study, they~     will complete a questionnaire. Participation in the study will end as soon as the~     questionnaire is completed.~   "
82947|NCT01971684|"~     The purpose of this study is to understand physician treatment decisions in selecting~     specific second line treatments in pediatric ITP and to determine the effectiveness of~     different second line ITP treatments. Eligible patients are those ages 1-18 years who are~     starting on a new second line treatment for ITP, defined as any treatment other than IVIG,~     steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for~     approximately one year.~   "
82948|NCT01971671|"~     To understand breast milk composition during different lactating stages.~   "
82960|NCT01971515|"~     This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to~     explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical~     activity signals of MSC2363318A.~   "
82949|NCT01971658|"~     This is a phase III, multicenter, prospective with a clinical benefit, open-label and~     randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide~     Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an~     Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly~     Diagnosed Multiple Myeloma.~      Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4~     consecutive 21 day cycles of an induction treatment with either VTD or VCD.~   "
82950|NCT01971645|"~     If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2~     mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.~   "
82951|NCT01971632|"~     The primary objective was to demonstrate the superiority of OXN over placebo over time from~     the initial dose of study medication to multiple pain events (inadequate analgesia) during~     the double blind phase.~   "
82952|NCT01971619|"~     To investigate the effect of vitamin D deficiency on the development of arrhythmia in~     patients with acute myocardial infarction.~   "
82953|NCT01971606|"~     Periprocedural treatment with high-dose statins is known to have cardioprotective and~     pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.~      -Objective: to determine whether preoperative rosuvastatin loading is independently~     associated with reduced myocardial ischemia and clinical outcomes in patients with stable~     angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary~     syndrome.~      Study design~        -  Prospective, double-blinded, single-center study of each 117 subjects enrolled~        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria~          will be enrolled preoperatively.~        -  Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B)~          Placebo (n=117).~        -  The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a~          total~        -  All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will~          be compared at 30 days and 2 years postoperatively between two groups~   "
82954|NCT01971593|"~     Hypothesis:~      By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the~     great vessels with a prior atrial switch, and single ventricle Fontan patients, incident~     heart failure will be delayed, symptoms of heart failure ameliorated, and risk of~     arrhythmias decreased through decreases in myocardial fibrosis.~      Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6~     minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months~     without therapy, after 6 months on therapy, then finally after 12 months of eplerenone~     therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12~     months on therapy. Patients will be randomly assigned to drug free period up front versus at~     the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and~     titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel~     analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12~     months for monitoring.~   "
82955|NCT01971580|"~     Hypothesis:~      Patients with a Fontan type palliation are limited by preload, or the rate at which blood~     returns to the heart after passively traversing the pulmonary capillary bed. By decreasing~     pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular~     filling pressures and volumes will increase with a simultaneous decrease in systemic~     impedance to flow and decrease in central venous pressures, leading to an improved capacity~     to increase cardiac output, and thereby an improvement in patient functional status.~      Patients who are candidates for the study will be randomized to a double-blind single~     crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks,~     with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2~     max test to evaluate exercise capacity at enrolment, and on the last day of each treatment~     period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope,~     ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic~     parameters as typically obtained from cardiopulmonary testing will be assessed. In addition,~     each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment,~     and on the last day of each study period.~   "
82956|NCT01971567|"~     The purpose of this study is to determine whether the addition of High-resolution,~     relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve~     insomnia symptoms based on changes in the Insomnia Severity Index at two months following~     completion of the intervention, compared to placebo plus usual care.~   "
82957|NCT01971554|"~     This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics~     (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled~     in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic~     agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary~     hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a~     dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction~     from baseline is ≥34 mg/dL.~   "
82958|NCT01971541|"~     The proposed study is a randomized, controlled trial that will assess whether two group~     interventions for PTSD - Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing~     Therapy-Cognitive only (CPT-C) result in similar improvements in PTSD symptoms and~     health-related quality of life (QOL). One hundred fifty-two Veterans with PTSD will be~     randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place~     post-treatment and 3 months later.~   "
82959|NCT01971528|"~     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD).~     Past research indicated that more than half of the individuals with PD demonstrated fatigue~     symptom. The severity of fatigue was also correlated to the quality of life in individuals~     with PD. Finding the contributions of the central and the peripheral factors to fatigue and~     developing an effective training program for individuals with PD are very important.~      Fatigue can be categorized into peripheral or central causes. The central fatigue and~     voluntary activation failure originate from the decrease in motivation or the reduction of~     the conduction within corticospinal tracts. Long term activation failure and central fatigue~     will cause disuse of muscle and result in peripheral weakness and peripheral fatigue.~     Quantifying the weighting of central versus peripheral factors contributing to the fatigue~     in people with PD is important.~      Most of the conventional strength and endurance training programs were based on the~     researches of young groups. Almost no training program was design for enhancing the~     voluntary activation level and relief the central fatigue. Seeking an appropriate training~     program to enhance central activation is very important for individuals with PD who prone to~     fatigue.~      Previous studies have shown that increasing afferent input by peripheral electrical~     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary~     sensory cortex, the excitability of corticospinal tracts, and the functional performance in~     young adults. Combining afferent input with strength training was more effective than~     strength training along. ES, which is easy to quantify the dose of afferent input, is a~     feasible method to provide such training.~      The purpose of this project is to investigate the effects of the combination of ES at~     sensory threshold and strength training on voluntary activation in the individuals with PD.~   "
82961|NCT01971502|"~     The objective of the single rising dose part (SRD) is to investigate safety, tolerability,~     pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male~     subjects. The objective of the food effect part (FE) is to investigate the relative~     bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.~   "
82962|NCT01971489|"~     This phase I trial studies the side effects and the best doses of buparlisib, gemcitabine~     hydrochloride, and cisplatin in treating patients with solid tumors that have spread to~     other places in the body. Buparlisib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving buparlisib,~     gemcitabine hydrochloride, and cisplatin may be a better treatment for solid tumors.~   "
82963|NCT01971476|"~     The present trial will be performed according to an open design to determine the maximum~     tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in~     paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less~     than 18 years. A further objective is to collect data on safety, tolerability, toxicity,~     efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in~     paediatric cancer patients~   "
82964|NCT01971463|"~     This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral~     blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke~     within 96 hours of enrollment. The study intervention will be a one hour monitoring session.~     There will be a 15 minute baseline measurement period, followed by intravenous~     administration of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring~     post-bolus. All study measurements will cease after 1 hour. Subjects will be followed during~     their hospitalization for 7 days or until discharge, whichever is sooner, to monitor for~     adverse events and to collect clinical information.~   "
82965|NCT01971450|"~     Local, prospective, multicenter, non-comparative, non-interventional, observational study.~     It is planed to assess compliance of patients with PH (pulmonary hypertension) with the~     physician's recommendation in real practice.~   "
82966|NCT01971437|"~     This is an ethically approved randomised controlled study looking at whether~     Cystodistension(filling the bladder with fluid under pressure) provides any benefit over~     cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine~     samples will also be assessed for underlying infected cause of OAB using urinalysis,~     microscopy and culture and cytokine assays (In collaboration with the University of Kent).~     We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB~     and the there is an increase prevalence in chronic urinary infections with raised cytokines~     in women with refractory OAB.~   "
82967|NCT01971424|"~     Magnesium deficiency is associated also in the elderly with low physical performance;~     nevertheless trials about the effect of supplementation of magnesium on physical performance~     are not available in old people. The aim of our study is to investigate whether 12-weeks of~     oral magnesium supplementation improves physical performance in healthy elderly women~   "
82968|NCT01971411|"~     In order to make bone health a reality for older adults, we need to consider the prevalence~     of Vitamin D deficiency in relation to environment latitude as well as vitamin D~     supplementation. Darker skin pigmentation and aging are known factors influencing the body's~     ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document~     vitamin D deficiency in elderly African American women living in a southern latitude.~   "
82969|NCT01971398|"~     This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome~     in Russian children through development of printed FAS education materials targeting women~     of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The~     rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not~     precisely known. At this time, there are no programs to prevent FAS in Russia. The results~     of our previous study, focus groups with health professionals, pregnant women and their~     partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge~     about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and~     print resources related to this topic. Based on the initial findings, this proposal aims to~     develop and evaluate in a clinical trial informational brochures for women to increase~     knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested~     are:~        -  1. Compared to the control group (CG) of women who receive a standard locally available~          flyer with health recommendations, women in the experimental groups who are exposed to~          printed information on FAS will show significantly more knowledge about FAS,~          significantly less acceptance of any alcohol use during pregnancy, and reduced drinking~          at one month follow-up assessment.~        -  2. The group exposed to a brochure with negative images (IGN - Intervention group with~          a negative brochure) regarding drinking during pregnancy will show significantly~          greater change in the predicted directions compared to the group exposed to positive~          images (IGP - Intervention group with a positive brochure) at the one month follow-up~          assessment.~   "
82970|NCT01971385|"~     Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE~     or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid~     or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized~     with placebo solution will receive placebo solution on their cold sore within 72 hours of a~     recurrence. Subjects will be followed for up to 6 mos after application of study medication.~   "
82971|NCT01971372|"~     Specific Aim 1: To identify differences in pain perception and satisfaction with pain~     control in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory~     (NSAIDS) postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac.~     Specific Aim 2: To compare the differences in narcotic usage and medication side effects.~   "
82987|NCT01971164|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),~     and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days~     in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.~   "
89756|NCT01882478|"~     The purpose of this study is to determine whether cryotherapy is effective in the treatment~     of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in~     patients who have not responded to radiofrequency ablation (RFA).~   "
82972|NCT01971359|"~     This study is determining the clinical outcomes, based on neurological testing, for the~     parafascicular minimally invasive clot evacuation technique. We will collect data from the~     time of surgery up until 90 days post procedure. We will also be looking at financial data~     as well.~        -  H(0): there is no economic benefit to the system with early surgical intervention for~          ICH~        -  Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical~          outcome with early surgical intervention (null hypotheses) H(0) is correct), the~          ability to accelerate the patients care from the entry point to the exit point will~          result in a significant economic advantage to the system through cost reduction.~   "
82973|NCT01971346|"~     The purpose of this study is to determine the relationship between two types of cell signals~     (type I IFN and TNF) in psoriatic skin prior to and during treatment with etanercept and~     correlate that information with the degree of the improvement in the psoriasis.~   "
82974|NCT01971333|"~     The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload~     variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g.~     stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It~     is not yet clear that dynamic preload parameters based on which mechanism will be accurate~     to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to~     claried which dynamic preload parameters would be more accurate during the liver~     transplantation.~   "
82975|NCT01971320|"~     Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration~     pneumonia and denutrition. It could be present in the majority of central neurological~     disease (degenerative or vascular disease), which explains that it is the first case of~     mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate~     that sensitive transcutaneous electrical stimulation could improve swallowing coordination~     and reduce aspirations. This technique could be used at home.~      The aim of this study is to demonstrate that sensitive electrical stimulation could improve~     oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in~     seven centers. Sensitive electrical stimulation will be applied either as active~     stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz~     during 30 minutes, under motor threshold and above sensitive threshold. It will be~     administrated via surface electrodes over the hyoid bone. Patients will be separated by~     randomisation.~      Patients will be evaluated before and after 6 weeks of use. Methods will evaluation~     questionnaire, clinical examination and videofluoroscopy. The time of use will also be~     collected.~      We wish to demonstrate that transcutaneous electrical stimulation is able to improve~     oropharyngeal dysphagia in stroke.~   "
82976|NCT01971307|"~     Although effective treatments for psychosocial symptoms and disorders are available,~     patients frequently do not receive the most appropriate and effective treatment for their~     symptoms because of inappropriate and unstructured diagnostics of psychosocial symptoms in~     general practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical~     symptoms of patients can be assessed more uniformly and earlier as opposed to the GPs'~     assessment in usual care. As a result, patients are supposed to start earlier with a~     treatment that fits the type and severity of their symptoms better.~      The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.~   "
82977|NCT01971294|"~     Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint~     stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or~     pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as~     narcotic medication use, puts patients at higher risk of secondary bladder filling and~     voiding dysfunction. In another hand, few case report and small sample observational studies~     have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more~     frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one~     (lcSSc). But prevalence or incidence is unknown.~      Urinary symptoms are seldom reported by those suffering from them and are rarely part of a~     systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be~     of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore~     urinary tract involvement might predispose to urinary tract infection due to flow limitation~     and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive~     form of disease conferring a greater loss of physical function, higher risk for hospital~     admission and death.~      Thus, identifying urinary symptoms would permit to address specific rehabilitation or~     medication therapy, in order to minimize the consequences of the bothersome symptoms and~     identify those subjects at higher risk of urinary infection, aggressive disease/loss of~     function or death.~      This study will also give basement to build an interventional study directed toward LUTS~     treatment in this population.~      In this prospective cohort we would like to:~        -  Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited~          forms of systemic sclerosis.~        -  Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS~          among patients suffering from systemic sclerosis.~        -  Evaluate the impact of LUTS symptoms on Quality of life.~        -  Compare the discrimination ability of Cochin-hand score and HAQ score to predict~          incontinence in this population.~        -  Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract~          infection, mortality and loss of autonomy.~   "
82978|NCT01971281|"~     The study is a prospective, double arm, non-randomized, open label pilot trial, designed to~     study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L~     concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for~     front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable,~     battery operated device for chronic administration of alternating electric fields (termed~     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated~     electrode arrays.~   "
82979|NCT01971268|"~     In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch~     concept compared to the use of platform-matched concept, refrain marginal bone loss during~     osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement~     of the final restoration = at 18 weeks=T2)~   "
82996|NCT01971047|"~     The purpose of this study is to compare the safety and efficacy of intravenous (IV)~     administration of FDA approved regular human insulin and subcutaneous (SC) administration of~     humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of~     hyperglycemia (high blood sugar) during the immediate preoperative period in patients with~     diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC).~      In this randomized controlled clinical trial patients with diabetes will be administered~     corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to~     determine whether SC humalog results in improved intra and post-operative blood sugar~     control.The most common current practice at Emory University in the ambulatory surgical~     setting is IV administration of regular insulin for treatment of pre-operative~     hyperglycemia. Subjects will not be paid for their participation and will be assured of~     treatment for their hyperglycemia regardless of study participation.~   "
82980|NCT01971255|"~     Background:~      - Researchers want to know if a certain type of antibody in the blood affects whether people~     get influenza (the flu). They will study 2 different groups with different levels of anti-HA~     antibodies and expose them to the flu virus. They will study how the flu develops in a~     healthy person. This may lead to future studies to develop new vaccines and treatments for~     the flu.~      Objective:~      - To study how people can be protected from flu infection.~      Eligibility:~      - Healthy volunteers 18 to 50 years of age.~      Design:~        -  Participants will be screened through the use of a medical history, physical exam, and~          laboratory tests.~        -  Groups of 7 participants will stay in an isolation unit in a hospital for at least 9~          days with no visitors.~        -  Participants will be screened again upon admission. They will also have:~        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s~          electrical signals.~        -  Echocardiogram: a small probe will be held to the chest to take pictures of the heart.~        -  Lung tests: participants will blow into a machine.~        -  They will also have nasal fluid collected. This will be done either with a swab or with~          a tube of water washing out the nose. This will be done once every day.~        -  The flu virus will be sprayed into the participant s nose. This will be done only once.~        -  Participants will complete a questionnaire on day 1 and twice a day after that for 14~          days.~        -  A medical team will watch participants 24 hours a day. They will go home after 2 days~          of negative flu tests.~        -  Participants will have 4 follow-up visits over 8 weeks.~   "
82981|NCT01971242|"~     This study is a clinical trial in patients with Parkinson's disease, of a drug called~     Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes.~     There have been several groups that have confirmed that Exenatide has beneficial effects on~     nerve cells when tested in the laboratory, that raises the possibility that Exenatide may~     slow down or stop the degenerative process of Parkinson's disease. In an open label trial in~     patients with Parkinson's disease who self administered the drug for 1 year, we have~     previously shown that the drug is well tolerated and shows encouraging effects on the~     movement and non-movement aspects of the disease, even 2 months after patients stopped~     administering the drug. The next step is therefore to formally evaluate whether Exenatide~     really is a potential neuroprotective drug, i.e. stops the nerve cells dying in~     Parkinson's disease, by conducting a double blind, placebo controlled trial.~   "
82982|NCT01971229|"~     Surgery is a stress on the body and recovering well after surgery is very important to~     patients and their doctors. It is therefore important to prepare patient's bodies for the~     stress of surgery, and one way to do this is to provide proper nutrition. In the past,~     patients were asked to prepare for surgery by fasting from midnight before surgery. Today,~     it is known that this practice is not beneficial to patient's recovery. In fact, it has been~     recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the~     production of insulin, which is a hormone that helps make the proteins needed for wound~     healing after surgery. This is currently practiced at the MUHC. It might also be beneficial,~     however, to drink a beverage that contains sugar and whey proteins (a protein isolated from~     milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added~     benefit of improving muscular strength. In this study, investigators will measure the level~     of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to~     determine how it compares to the level of insulin produced after drinking the sugary~     beverage used at the MUHC.~   "
82983|NCT01971216|"~     Primary hypotheses~      1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week~     2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of~     a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable~     effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant~     vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)~      Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy~     intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk~     (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and~     hence infant growth and body composition.~   "
82984|NCT01971203|"~     The primary objective of the study is to determine whether quetiapine extended-release in~     combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo~     in treating depressive and anxiety symptoms in patients with both major depression and~     generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly~     assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting~     about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in~     which medication will be discussed. Both clinician administered and self-report measures~     will be used to compare groups before and after 16 weeks.~   "
82985|NCT01971190|"~     Central serous chorioretinopathy (CSC) is a self-limiting disease that usually associated~     with good visual prognosis. In some cases, however, CSC may persist and result in permanent~     retinal or retinal pigment epithelium (RPE) damage. Therefore, if the disease is persistent~     beyond the acute phase, an active treatment should be considered to prevent an irreversible~     damage to retinal function.~      The pathophysiology of CSC is associated with abnormal choroidal circulation. Indocyanine~     green angiography (ICGA) has revealed dilated and congested choroidal vessel and leakage~     into the extracellular space that appears as area of hyperfluorescence seen in middle and~     late phase in eyes with CSC.~      A goal of treatment has been focused on reducing choroidal hyperpermeability. Currently,~     photodynamic therapy with verteporfin (PDT) and intravitreal anti-VEGF (vascular endothelial~     growth factor)antibody injection are being tried in order to treat chronic CSC. PDT reduces~     choroidal hyperpermeability by inducing hypoperfusion of the choriocapillaris in the short~     term and choroidal vascular remodeling over time. Intravitreal anti-VEGF injection for the~     treatment of CSC also effectively reduces choroidal hyperpermeability by blocking vascular~     leakage. Both methods have shown to be effective with good functional outcome for treating~     chronic CSC in many reports, but until now there is no established standard treatment~     protocol for chronic CSC.~      Bevacizumab (Avastin) and ranibizumab (Lucentis) have been used widely as anti-VEGF~     therapeutic agent for the treatment of age related macular generation (AMD) and macular~     edema of various reasons. A newly developed anti-VEGF drug, aflibercept (Eylea○R), shows~     higher affinity to VEGF and has a longer duration of effect in the vitreous.FDA approved~     aflibercept to treat wet type AMD and macular edema due to central retinal vein occlusion.~      Until now, no study has been reported on the efficacy and safety of aflibercept for treating~     CSC. The aim of this study is to evaluate the efficacy and safety of intravitreal~     aflibercept injection for the treatment of idiopathic CSC~   "
82986|NCT01971177|"~     This clinical study is a randomized, controlled, open, prospective, multi-centre,~     multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract~     grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support~     phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.~   "
82988|NCT01971151|"~     RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining~     factor of chronic low back pain- while increasing level of daily functioning, despite the~     pain. This is done by exposing patients to their most feared activities/movements, while~     behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs~     about pain. Yet, performing exposure exercises might be very threatening for patients and~     might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking~     behavior should be allowed or not during therapy is heavily debated. Whereas some argue that~     it will only interfere with therapeutic progress because it prevents the disconfirming~     experience exposure tries to offer, other argue that it will facilitate therapeutic progress~     because it enhances one's sense of control, if used judiciously. So far~     (clinical-)experimental studies have provided mixed evidence nor have they lead to any~     clinical recommendation. Hence, in a replicated single-case experiment, we will compare~     exposure therapy with versus exposure without safety-seeking behavior versus exposure only.~      STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who~     fulfill all inclusion and exclusion criteria and participate voluntarily.~      INTERVENTION: All participants receive exposure therapy at the rehabilitation department of~     the academic hospital in Maastricht, but with different recommendations for the use of~     safety-seeking behavior.~      We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of~     goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing,~     pain solutions, need to control and safety-seeking behavior. To measure to the influence of~     safety-seeking behavior on actual level of functioning, two behavioral performance tasks~     will also be presented, ie. a bag carrying task and a personalized task.~      BURDEN AND RISKS: There are no risks associated with participation to this study that are~     not otherwise related to rehabilitation and movement in general and participation is~     completely voluntary. Participants are requested to fill out questionnaires on a daily basis~     at home (computerized if possible), as well as on different time points during the study and~     at follow up and perform two behavioral performance tasks. This study could help to further~     improve the beneficial long-term effects of exposure.~   "
82989|NCT01971138|"~     This study explores the routines of registration of surgical site infections (SSI) at~     different surgical centers in Sweden. It explores the sensitivity and specificity of the~     registration routines of SSI are at Halmstad County Hospital, Sweden.~   "
82990|NCT01971125|"~     The purpose of this study is to evaluate the prevalence, during the enrolment, of Left~     Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2~     without known or documented heart disease history and recognize its predictive clinical,~     biohumoral and with non-invasive techniques parameters.~   "
82991|NCT01971112|"~     Poor Ecuadorian older people suffer from chronic dietary deficiencies of zinc, iron, copper,~     vitamins C, B6, B12, D, and folic acid. The investigators have previously shown that these~     deficiencies are associated with impaired immune function and increased incidence of~     respiratory infections (RI). The hypothesis is that correction of these specific nutrient~     deficiencies will improve immune response and thereby enhance resistance to respiratory~     infections. To test this hypothesis this study will evaluate the effect of supplementation~     with specific vitamins and minerals found to be deficient in poor elderly Ecuadorians on~     markers of immune function and the incidence of RI. A randomized, double-blind,~     placebo-controlled trial in 320 older people (≥65 y)will be carried out in Quito, Ecuador.~     Participants will receive multivitamin and mineral supplements or placebo tablets daily for~     12 months. Nutrients will be provided at US Recommended Daily Allowance (RDA) levels, except~     for vitamin C and zinc doses, which will be 5 times and 1.25 times higher than the RDA,~     respectively. Incidence of respiratory infections (the primary outcome) will be assessed~     weekly by field nurses and physicians from the study team. Secondary outcomes include~     delayed-type hypersensitivity (DTH) skin test, cathelicidin production by mucosa respiratory~     cells, and serum C-reactive protein (CRP) as measures of immune function. Blood~     micronutrient levels and haemoglobin status will be collected as measures of adherence to~     the trial regimen. Incidence rate of RI and rate ratio (RR) will be calculated to quantify~     the effect of the intervention on the incidence of respiratory infection. This will be the~     first trial of its kind conducted specifically in a population of older people known to have~     poor micronutrient status. The findings of the study may be important for similar~     populations in other low- and middle-income countries.~   "
82992|NCT01971099|"~     Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in~     society and is strongly linked to the quality of life of women. The androgen hormones~     decline over age in the premenopausal period, which occurs around 20 years. Tribulus~     terrestris is a plant native to India, recommended in the treatment of infertility, low~     libido and impotence. Its main active ingredient is the protodioscin, which has been~     attributed to an increase in testosterone levels and improved sexual function. The aim of~     this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with~     HSDD.~   "
82993|NCT01971086|"~     Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study~     (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus~     in everyday curative routine treatment of acute rhinitis~   "
82994|NCT01971073|"~     A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive~     suppression is the ability to control or suppress irrelevant responses and to adopt relevant~     responses instead. The purpose of this study is to investigate the effects of transcranial~     direct current stimulation (tDCS) on information suppression in schizophrenic patients. This~     is a noninvasive technique of brain stimulation that induces prolonged functional changes in~     the cerebral cortex through the application of a weak direct current to the scalp (Nitsche &~     Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral~     prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.~   "
82995|NCT01971060|"~     Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the~     myomectomy, adhesions will be assessed using a modified AFS scoring technique. All~     investigators will provide usual and customary care to research subjects during the first~     look laparoscopy. This includes the use of all standard practice anti-adhesive agents and~     heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All~     patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after~     the initial surgery and reevaluated via modified American Fertility Society scoring~     techniques. An independent reviewer will also score adhesions utilize a video recording made~     from the second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks~     post -op and assessed for complications. It is the expectation that patients will show no~     greater post-operative adhesion formation and a <1% complication rate. Time and ease of~     suturing will also be evaluated. It is expected that the V-Loc suturing technique will show~     significantly reduced suturing time, be easier to use, and will be associated with minimal~     adhesions.~   "
83010|NCT01970852|"~     The aim of this study is to evaluate the impact of an inpatient personal health record (PHR)~     portal intervention within the hospital environment. The intervention hopes to improve~     patient engagement with their care and to measure patient activation and satisfaction.~     Additional clinical measure (e.g. number of adverse events that occur during the stay,~     changes to medication orders, etc.) will also be studied. Characterization of hospital~     patient and clinician attitudes towards patient engagement will also be formalized.~   "
83097|NCT01969786|"~     VIEW is a community-randomized trial designed to determine whether it is possible to prevent~     corneal ulcers on a large scale. The study compares the incidence of corneal ulceration~     between villages in which volunteers are trained to diagnose and treat corneal abrasions and~     villages which receive no intervention.~   "
82997|NCT01971034|"~     In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an~     uncommon disease, however very aggressive.Only 20% of cases are indicated for curative~     surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic~     disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for~     first line, with survival around 6 months approximately.There is no standard treatment~     regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II~     study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There~     is a growing number of preclinical studies which show antitumor effect against pancreatic~     adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study~     will add metformin to standard treatment for second line of locally advanced or metastatic~     pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to~     evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel~     by clinical and radiological evaluation.~   "
82998|NCT01971021|"~     As of today there is very limited scientific knowledge in whicj of the two vascular access~     devices (PICC-line or venous ports) that offers the lowest complicationrates in~     cancerpatients. The study group wants to clearify this unsolved matter by comparing the two~     systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are~     also looking at all catheter related complications and patient satisfaction.~   "
82999|NCT01971008|"~     The purpose of the present study is to determine whether the use of an abdominal binder is~     effective in the non-pharmacological management of orthostatic hypotension in patients~     suffering from Parkinson's disease~   "
83000|NCT01970995|"~     The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS~     2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by~     Japanese adult healthy smokers results in a reduction in the levels of biomarkers of~     exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to~     smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC)~     and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark~     to provide context to the exposure reduction.~   "
83001|NCT01970982|"~     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating~     System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the~     levels of biomarkers of exposure for selected harmful and potentially harmful constituents~     (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).~   "
83002|NCT01970969|"~     Our primary hypothesis is that a risk score comprised of approximately 10 single nucleotide~     polymorphisms (SNPs) that are associated with atrial fibrillation at the Genome Wide~     Association Study (GWAS) level is associated with the development of atrial fibrillation~     among previously undiagnosed patients at high risk for atrial fibrillation. A current~     example of these SNPs is shown in Table 1. As a secondary hypothesis, we will test the~     association between atrial fibrillation diagnosed in this study with a subset of SNPs~     reported to be associated with atrial fibrillation and with fine-mapping SNPs. We will also~     test the association between atrial fibrillation of less than and greater than 30 seconds~     and a panel of approximately 10 SNPs.~   "
83003|NCT01970943|"~     The placebo effect is a phenomenon that has experienced major advances of its understanding~     in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have~     yet to be compared to healthy subjects. The investigators study aims to investigate the~     magnitude of placebo response and related opioid release in patients that suffer from~     episodic migraines as compared to healthy controls. In particular, the investigators are~     looking to map brain activity during placebo analgesia using modern brain imaging techniques~     such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET).~     The investigators hypothesis is that placebo response and the availability of opioid~     receptors is reduced in chronic migraine patients.~   "
83004|NCT01970930|"~     The purpose of the study is to isolate and characterize stem cells of patients with~     Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are~     not working the way they should be and why they seem to be sensitive to regulatory factors~     in the blood, such as clotting.~   "
83005|NCT01970917|"~     Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population.~     Despite many treatment approaches, instillation of topical lubricants remains the mainstay~     of therapy. However, most of the topical lubricants available are not very well~     characterized and data about efficacy is sparse.~      The aim of the present project is to investigate the effect of topically administered Olixia~     pure® eye drops on tear film thickness in healthy subjects.~      Tear film thickness will be determined using ultra high-resolution optical coherence~     tomography (OCT). Measurements will be performed before instillation of the eye drops and~     every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye~     drops, the fellow eye will receive physiologic saline solution as placebo control. The study~     eye will be chosen randomly.~   "
83006|NCT01970904|"~     This study will explore the relationship of different DEB025 doses in combination with RBV~     to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in~     chronic hepatitis C GT 2 and 3 treatment naïve patients.~   "
83007|NCT01970891|"~     Potential for electrical stimulation to relieve Freezing of Gait (FOG)~   "
83008|NCT01970878|"~     This is a multi-center, randomized, double-blind, parallel group, chronic dosing,~     active-controlled, 28-week safety extension study of the two pivotal 24-week safety and~     efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the~     long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)~     combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate~     to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is~     included as an active control. To be eligible for this study, a subject must complete~     participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).~   "
83009|NCT01970865|"~     Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient~     reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer~     patients and ROS1+ advanced non small cell lung cancer patients .~   "
83039|NCT01970475|"~     The purpose of this study is to compare the effectiveness and safety of ABP 501 against~     adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an~     inadequate response to methotrexate (MTX).~   "
83011|NCT01970839|"~     There are a number of risk factors for development of chronic pain that have been evaluated~     including age, gender, type and duration of surgery, duration of pain prior to surgery and~     tourniquet application. There is some scientific evidence from animal studies demonstrating~     that prolonged tourniquet application can result in lack of oxygen supply to nerves, and~     subsequent nerve damage resulting in chronic pain. This theory has not been proven in~     humans. In this study the investigators will indirectly assess the evidence for~     abnormalities caused by tourniquet application on subjects' nerves using well established~     devices to determine the function of these nerves.~   "
83012|NCT01970826|"~     In patients that require dental implants , does performing the surgery in clean sterile~     field compared to aseptic field, produces more post-operatory complications, implant~     morbidity or patient discomfort ?~   "
83013|NCT01970813|"~     The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture~     (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and~     investigate whether there is sustainability of treatments effects by follow-up assessments~     after the end of the treatment.~   "
83014|NCT01970800|"~     The purpose of the study is to evaluate the predictive value of IGF-1 generation test for~     growth velocity during GH treatment for 12 months.~   "
83015|NCT01970787|"~     This is a Single-center prospective pilot trial involving up to 22 subjects. This study will~     assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal~     canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in~     HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study~     intervention will demonstrate that a reasonable proportion of subjects will be~     histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe~     manner~   "
83016|NCT01970774|"~     This study aims to investigate the benefit and feasibility of providing pharmacogenetic~     (PGx) testing as part of a standard medication therapy management (MTM) session for patients~     taking multiple medications, a high-risk population for adverse drug reactions and~     non-response. Research participants will attend two MTM sessions and undergo PGx testing to~     inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing.~     Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing,~     clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues~     are minimal with the primary risks being associated with loss of confidentiality, typical~     discomfort associated with acquiring blood samples, and genetic discrimination.~   "
83017|NCT01970761|"~     Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic~     pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar~     quality, but scantly study has explored its effects on pain. The aim of the study was to~     survey its effect on pain.~   "
83018|NCT01970748|"~     Randomized comparison within the endoscopic esophageal varices ligation versus non-selective~     beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.~   "
83019|NCT01970735|"~     The aim of the study was to compare the severity of illness between groups of patients~     (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).~      Despite advances in research on the subject, answers are still needed on these diseases.~      We also aim to determine whether the chromosomal genetic abnormality is involved in other~     diseases and the frequency of this mutation in the population of patients FSHD.~      This study will increase our knowledge of the two forms of FSHD who present a common~     pathophysiological mechanism and may occur together in the same family with a worsening of~     the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1~     and type 2 seems to have clinical consequences requiring appropriate management~   "
83020|NCT01970722|"~     This clinical trial studies the side effects and how well surgery and heated chemotherapy~     with or without non-heated chemotherapy after surgery works in treating patients with~     ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy~     into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or~     peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated~     chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.~   "
83021|NCT01970709|"~     This multicenter Registry is to assess whether the use of pharmacogenomic data results in a~     meaningful change in a subject's drug or dose regimen. In addition, the Registry will~     evaluate the relationship between adverse drug reactions (ADR) and genotype and assess~     resource utilization (emergency department visits and hospitalizations) associated with ADR.~   "
83022|NCT01970696|"~     Rare tumors are understudied, yet have the potential to shed light on vast areas of cancer~     research. Ovarian sex cord-stromal tumors, rare tumors of childhood and young adulthood,~     have recently been found to be associated with a lung cancer of early childhood called~     pleuropulmonary blastoma (PPB). The cause of these ovarian tumors is unknown. DICER1~     mutations are seen in the majority of children with PPB. Research shows DICER1 mutations are~     also seen in some patients with ovarian tumors. Like PPB, ovarian stromal tumors are highly~     curable when found in early stage; however, later forms of the disease are aggressive and~     often fatal. The International Ovarian Stromal Tumor Registry collects clinical and biologic~     data to understand why these tumors occur and how to treat them. Current work involves the~     study of the role of DICER1 and miRNA expression in ovarian stromal tumors. Understanding~     the clinical history, predisposing factors and DICER1 and miRNA expression in these ovarian~     tumors of childhood will lead to targeted screening and risk stratification for~     evidence-based treatment and biologically rational therapies. These efforts will improve the~     lives of children by increasing survival and reducing late effects.~      The specific goals of the International Ovarian and Testicular Stromal Tumor Registry are:~        1. to understand risk factors by studying age, pathologic subtype, histopathologic~          features, tumor invasiveness, degree of differentiation, presence of metastasis~        2. to collect information on personal and family history in order to refine the clinical~          characteristics of patients and families with and without germline DICER1 mutations and~          other genetic predisposing factors~        3. to determine whether there is a pattern of gene expression or DNA alterations that~          correlate with predisposition to ovarian tumors, biologic behavior and clinical outcome~        4. to determine optimal screening regimens~        5. to use clinical data obtained through the Registry to refine treatment algorithms~        6. to establish a collection of annotated biology specimens (tumor tissue and germline~          DNA) for future research~   "
83023|NCT01970683|"~     The study will investigate whether probiotics given just before and shortly after major~     abdominal operation improve outcomes.~   "
83024|NCT01970670|"~     The primary objective is to determine how accurately one can estimate the size of the index~     tumor on preoperative imaging in patients with known breast cancer, using pathology as a~     reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the~     maximum diameter (mm) of the index tumor.~   "
83025|NCT01970657|"~     This observational safety follow-up study will enroll subjects from the 802-247-09-032 study~     with the investigational product HP802-247 for venous leg ulcers who received at least one~     application of HP802-247 or Vehicle (Placebo). This study is being done for the following~     purposes:~        1. to identify new adverse events,~        2. to examine ongoing adverse events not resolved in subjects who participated in the~          802-247-09-032 trial,~        3. to record wound status, and~        4. to determine if there are differences in Health Related Quality of Life (HRQoL)~          associated with the treatment assignment from the 802-247-09-032 Trial.~      About 440 subjects will participate depending upon subject enrollment from the previous~     study, 802-247-09-032. The study is going to be conducted in approximately 50 sites in~     Europe~   "
83026|NCT01970644|"~     Cancer which spreads to the brain (brain metastases) is a common and significant problem.~     Historically, whole-brain radiotherapy has been used to treat these patients but has a~     negative effect on cognition. Radiosurgery is an alternative treatment with potential for~     fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of~     patients with multiple brain metastases is not well studied. We propose a pilot study at the~     Winnipeg Centre for Gamma Knife Surgery to examine this issue.~   "
83027|NCT01970631|"~     The objectives of this research are to conduct a proof of concept randomized controlled~     trial with 200 patients undergoing primary total knee replacement (TKR) at Brigham and~     Women's Hospital (BWH). The trial will compare levels of physical activity in subjects in~     the behavioral and economic interventions versus Usual Care post TKR.~   "
83028|NCT01970618|"~     RV1162 is a new medicine being developed for possible treatment of smoking related lung~     disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of~     this study is to investigate the safety, tolerability and pharmacokinetics of single and~     repeat doses of RV1162.~   "
83029|NCT01970605|"~     This web based e-Registry will be international, multi-center and prospective. Silver Graft~     e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient~     population~   "
83030|NCT01970592|"~     Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen~     in three-quarters of individuals following stroke. Weakness in this population results from~     both neural and muscular factors which include, respectively, the ability to activate~     skeletal muscle as well as the force generating capacity of the muscle. The overall goal is~     to improve walking in persons post-stroke by training subjects with an intervention that~     specifically targets existing neural and muscular impairments, thereby facilitating~     locomotor recovery.~   "
83031|NCT01970579|"~     The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon~     catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial~     femoral artery and the proximal two segments of the popliteal artery with reference~     diameters ≥ 4mm & ≤ 7mm and lesion lengths ≥ 4 cm & ≤ 27 cm. It is the intention of this~     trial to treat suitable target lesions with DCB only.~   "
83032|NCT01970566|"~     Obesity is a prevalent disorder and linked with inflammation, insulin resistance,~     dyslipidemia, obstructive sleep apnea, atherosclerosis, and associated with significant~     morbidity and mortality. This randomized clinical trial will compare the effectiveness of~     Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and~     cognitive behavioral therapy (CBT) on obesity and atherosclerosis in individuals with~     morbidly obesity. This randomized clinical trial will compare: 1) the change in fat mass and~     atherosclerosis, 2) the change in psychological and quality-of-life as well as economic~     burden in response to IE-MCR, TP and CBT, and 3) conduct exploratory mechanistic~     biomolecular, genetic and therapeutic analyses to develop intervention-specific~     individualized intervention models to improve management of morbidly obese individuals.~   "
83033|NCT01970553|"~     Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in~     combination with gemcitabine in non-heavily pretreated patients with selected advanced solid~     tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of~     PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility~     of this combination in patients with selected advanced solid tumors, to characterize the~     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity~     in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics~     (PGx) in tumor samples of patients exposed, in order to assess potential markers of response~     and/or resistance.~   "
83034|NCT01970540|"~     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in~     Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected~     Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose~     (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and~     feasibility of this combination, to characterize the pharmacokinetics (PK) of this~     combination, to obtain preliminary information on the clinical antitumor activity,to explore~     the feasibility, safety and efficacy of a potential improvable dose of this combination in~     selected tumor types [i.e. small cell lung cancer (SCLC) and endometrial cáncer] and to~     evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and~     doxorubicin at the RD in order to assess potential markers of response and/or resistance.~   "
83035|NCT01970527|"~     This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in~     treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal~     antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor~     cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.~   "
83036|NCT01970514|"~     To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess~     preliminary cost/benefit analysis in patients undergoing decompression surgery for~     symptomatic lumbar disc herniations.~      The general hypothesis is that the ARO significantly improves outcomes in patients~     undergoing decompression surgery for symptomatic lumbar disc herniations.~   "
83037|NCT01970501|"~     This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to~     metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial~     flutter in patients with heart failure who have a specific genotype for the beta-1~     adrenergic receptor.~   "
83038|NCT01970488|"~     The purpose of this research study is to compare the efficacy and safety of ABP 501 and~     adalimumab (HUMIRA®) in adults with plaque psoriasis.~   "
83040|NCT01970462|"~     This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in~     patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will~     receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient~     population due to the effects on hepatic glucose production (a major feature of SH), safety~     (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and~     tolerability. The secondary objective of this study is to determine whether the management~     of patients with persistent insulin requirements following cardiac surgery differs among~     patients with stress hyperglycemia or mild diabetes.~   "
83041|NCT01970449|"~     The purpose of this study is to test the safety and immune response to three different sets~     of HIV vaccines in healthy, HIV-uninfected adults.~   "
83042|NCT01970436|"~     Not all pregnant women have the same risks for pregnancy complications. Women at low-risk~     for pregnancy complications may not need the same type of prenatal care. The goal of this~     study is to learn about the use of telemedicine for low-risk pregnant women and improve the~     delivery of prenatal care. Telemedicine is medical care provided using a computer or~     telephone to visit with a doctor for some medical appointments. Participating patients will~     be assigned by a computer to either standard prenatal care, or prenatal care involving a~     combination of standard prenatal visits and telemedicine visits. Both groups will have the~     same number of prenatal care visits.~      In both groups, we will ask about the patients' satisfaction with their care, the amount of~     time they spent visiting with their doctor, and information about time and their expenses.~     In the telemedicine group, we will teach how to measure blood pressure, fetal heart rate,~     and weight from home.~      The goals of this study are to: 1) assess the patient satisfaction, patient experiences and~     preferences, financial impact, clinical outcomes, and provider satisfaction of providing~     personalized prenatal care for low-risk pregnancies using telecommunication and remote~     patient care devices; and 2) measure the reliability of at-home, patient-recorded,~     computer-documented prenatal care measurements. The primary outcome is patient satisfaction~     with prenatal care after delivery.~   "
83043|NCT01970423|"~     Cardiac resynchronization therapy may reduce central sleep apnea, but there is no~     prospective randomized study so far demonstrating such an effect in patients with~     conventional pacemaker undergoing upgrading to CRT because of heart failure.~   "
83044|NCT01970410|"~     The purpose of this study is to determine if teriflunomide will be safe and effective to~     prevent relapses in patients with relapsing types of MS when switching from natalizumab to~     teriflunomide in patients at risk for PML. This is a two center interventional study of~     patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab~     positive, and who had been free of clinical relapses during prior 12 months of natalizumab~     therapy who will be switching to teriflunomide.~   "
83045|NCT01970397|"~     A prospective, randomized, controlled, multi-center study of the safety and effectiveness of~     JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines~   "
83046|NCT01970384|"~     The purpose of this study is to evaluate whether transcranial direct current stimulation of~     the cerebral swallow motor cortex in addition to standard care can enhance recovery of~     swallow function in acute dysphagic stroke patients compared to sham treatment plus standard~     care.~   "
83047|NCT01970371|"~     This is a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1)~     comparing the efficacy and safety of plazomicin with colistin when combined with a second~     antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream~     infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated~     bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP,~     VABP, cUTI, or AP due to CRE, not eligible for inclusion in the other cohort, will be~     enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic~     drug management (TDM) will be used to help ensure that plazomicin exposures lie within an~     acceptable range of the target mean steady-state area under the curve (AUC).~   "
83048|NCT01970358|"~     This research study is evaluating a new type of melanoma vaccine called Personalized~     NeoAntigen Cancer Vaccine. The purpose of this study is to determine if it is possible to~     make and administer safely a vaccine against melanoma by using information gained from~     specific characteristics of the participant's own melanoma. It is known that melanomas have~     mutations (changes in genetic material) that are specific to an individual patient and~     tumor. These mutations can cause the tumor cells to produce proteins that appear very~     different from the body's own cells. It is possible that these proteins used in a vaccine~     may induce strong immune responses, which may help the participant's body fight any tumor~     cells that could cause the melanoma to come back in the future. The study will examine the~     safety of the vaccine when given at several different time points and will examine the~     participant's blood cells for signs that the vaccine induced an immune response.~   "
83049|NCT01970345|"~     The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of~     autism. We will use a double-blind, placebo-controlled crossover trial design in five~     children with autism to evaluate the impact of IGF-1 treatment on autism-specific~     impairments in socialization, language, and repetitive behaviors. We expect to provide~     evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in~     children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated~     with improvement on secondary outcomes of social impairment, language delay, and repetitive~     behavior, as well as on functional outcomes of global severity.~   "
83050|NCT01970332|"~     Intermittent claudication afflicts 5% of the US population older than 55 years of age and~     develops along with hardening of the arteries of the legs. Claudicating patients limp and~     can only walk very short distances because their legs hurt. This protocol evaluates the~     mechanisms that may produce the leg dysfunction of claudication and its successful~     completion can ultimately produce significant new diagnostic and treatment strategies for~     the care of claudicating patients.~   "
83078|NCT01970033|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the~     efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in~     Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise~     for 3 months~   "
83079|NCT01970020|"~     The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C~     JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C~     JNJ-38518168.~   "
83051|NCT01970319|"~     Patients with diabetes have a higher incidence of heart failure and worse outcomes than~     normoglycaemic subjects. Basic science research has suggested many mechanisms for this~     observation including endothelial dysfunction, abnormal calcium handling, fibrosis and~     activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are~     lacking. In this study the investigators will investigate the relationship between diabetes~     and heart failure by exploring the correlation between microvascular dysfunction and cardiac~     magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction~     and fibrosis. The investigators also propose to see if this relationship is independent of~     blood pressure and markers of RAAS activity. This could have important clinical~     ramifications in type 2 diabetes by increasing the indications for treatment with RAAS~     inhibition or making a case for lower blood pressure targets.~   "
83052|NCT01970306|"~     The purpose of this study is to see if implanting MatriStem will lower the risk of one of~     the more common complications after stomach or esophagus surgery.~   "
83053|NCT01970293|"~     The primary aims of this study are to test the hypotheses that among alcohol abusing and~     dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA)~     linkage intervention will result in less alcohol use at follow-up, increased AA attendance~     once released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to~     test the hypotheses that increased AA attendance will mediate the effect of the AA linkage~     intervention on alcohol use and that percent days abstinent will mediate the effect of the~     intervention on HIV/STI sexual risk-taking outcomes.~   "
83054|NCT01970280|"~     The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV~     graft thromboses in patients on chronic hemodialysis.~      Primary efficacy end point of the study: to compare the time of onset of a new thrombotic~     event after successful angiography of the AV graft.~      Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following~     a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on~     chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body~     weight per day or control group (not on Clexane). Patients will be followed for a year or~     till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare~     time periods in months between first and recurrent thrombotic events of AVG by evaluation~     the difference between two sample means. Also interim analysis of AV grafts patency between~     the two groups will be evaluated at different time points: three, six and twelve months~     after randomization. Patients in both groups will receive unfractionated heparin during~     dialysis session to prevent thrombosis of extracorporeal circulation. Patients from~     Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of~     bleeding during the session. Before randomization all patients will be evaluated for~     hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid~     antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.~   "
83055|NCT01970267|"~     Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid~     (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye~     conditions such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid~     hyalosis. While these symptoms are considered physiological in nature, they can be of~     considerable inconvenience to many patients which affect essential activities. The~     investigators wish to assess the safety and efficacy of floater treatment in patients with~     highly symptomatic floaters using an FDA approved nanosecond infrared yttrium aluminum~     garnet (YAG) lasers.~   "
83056|NCT01970254|"~     The goal of this clinical research study is to learn about testing patients for viral~     infections before chemotherapy. Researchers want to learn which patients are at higher risk~     for these infections so that, in the future, patients might be able to be tested more~     effectively.~   "
83057|NCT01970241|"~     Despite a significant problem with out-of-control glucose levels in patients with diabetes~     receiving corticosteroids for a variety of illnesses, there are no published protocols~     addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators~     propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn)~     insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is~     ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to~     the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing~     regimen. Investigators will prospectively enroll eligible consented patients with diabetes~     who are receiving corticosteroids as part of their treatment in a large county hospital,~     will randomize them to intervention or control groups, and will monitor their glucose levels~     during their inpatient stay. The protocol will demonstrate improved control of glucose~     levels with minimal risk of hypoglycemia, and will provide a practical and readily~     implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.~   "
83058|NCT01970228|"~     Total hip replacement is the well-established surgical method for treatment of hip~     osteoarthritis and related diseases. The outcome of the procedure is commonly satisfactory~     and most patients will not need any revision surgery. However, the procedure has its~     complications, including (1) periprosthetic infection, (2) mechanical loosening caused by~     wear particles and (3) allergic reaction caused by metal ions released from metal-on-metal~     bearing surfaces. The unsolved clinical problem is related to the differential diagnosis of~     these conditions. The purpose of this prospective clinical study is to compare the efficacy~     of two techniques of PET/CT imaging in the differential diagnosis of these complications.~     The PET imaging, performed during a single day, will include the head-to-head comparison of~     18FDG PET/CT and 68Ga-citrate PET/CT imaging.~   "
83059|NCT01970215|"~     The primary objective of this study is to evaluate the efficacy of different doses of~     TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of~     high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein~     cholesterol (LDL-C), alone and in combination with statin therapy.~      The secondary objectives of this study are to determine the safety and tolerability of~     TA-8995 in patients with mild dyslipidaemia.~   "
83080|NCT01970007|"~     The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the~     Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow~     obstruction.~   "
83081|NCT01969994|"~     The purpose of this study is to determine the absorption, metabolism and excretion of~     (-)-epicatechin using the radiolabeled tracer (-)-[2-14C]epicatechin in healthy male~     volunteers observing a flavanol-/procyanidin-controlled background diet.~   "
83060|NCT01970202|"~     Approximately two thirds of the adult population in developed countries is categorized as~     over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a~     major health concern. In the presence of numerous diets, medical therapies, and robust~     research, bariatric surgery remains the most effective means of weight reduction in morbidly~     obese patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a~     relatively high risk for postoperative complications; of them, venous thromboembolic events~     (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly~     obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.~      To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in~     the aforementioned population. Due to the pharmacologic properties of LMWH and the~     characteristics of surgically treated obese patients, the optimal dose that is to be~     utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa~     levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of~     0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.~      Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h)~     for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were~     small non- randomized trials, containing numerous methodological weaknesses. Hence, the~     optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed~     population remains unclear.~      The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing~     two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and~     homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric~     surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients~     undergoing bariatric surgery.~   "
83061|NCT01970189|"~     Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet~     count, which may cause the patient to have a higher risk or increased duration of bleeding.~     Individual hospitals only encounter a small number of ITP patients each year which makes it~     difficult to study this disease. By creating this disease registry, we will be able to build~     a more complete picture of ITP, including treatment practices, through collecting~     information about the condition from patients across several hospitals in several countries.~     Research of this kind will help future patients by providing doctors with information about~     ITP, and about how patients have been treated.~   "
83062|NCT01970176|"~     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo~     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral~     response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and~     renal (kidney) dysfunction.~   "
83063|NCT01970163|"~     The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers~     (DFU) and venous stasis ulcers (VSU).~   "
83064|NCT01970150|"~     The purpose of this study is to examine whether the rTMS (repetitive Transcranial Magnetic~     Stimulation) could change cortical excitability measured by off-line EEG in Alzheimer's~     Disease (AD) patients.~   "
83065|NCT01969747|"~     Placebo-controlled, double blind (triple-dummy technique), randomised parallel design~     comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with~     T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day~     open-label placebo run-in period before randomisation. Background insulin therapy will be~     kept stable during the first 7 days of the treatment period and will be freely adjusted~     thereafter.~   "
83066|NCT01969734|"~     Despite the best medical therapy many people with emphysema remain breathless and limited in~     their daily activities. In emphysema the lungs do not empty properly when the person~     breathes out. This gas trapping makes it harder to breathe. Endobronchial valve placement,~     a treatment that stops air getting into the worst affected parts of the lung and so stops~     them from trapping gas, improves lung function, breathlessness and exercise capacity in~     selected patients with severe COPD (chronic obstructive airways disease, sometimes referred~     to as emphysema). We want to see if people with less severe COPD who are very breathless can~     benefit from the same treatment. The treatment involves placing small valves into the~     airways using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical~     procedure carried out in our department.~   "
83067|NCT01969721|"~     The objective of the trial is to compare the lung function profile of once daily treatment~     with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung~     function profile of twice daily treatment with fluticasone propionate+salmeterol FDC~     [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.~   "
83068|NCT01969708|"~     SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all~     participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a~     non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg)~     every 4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine~     if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated~     with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity~     measured at Month 6.~   "
83069|NCT01969695|"~     This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's~     lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma~     [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active~     and assigned to ABT-199 when the study was completed, may roll over into this extension~     study. Subjects will receive ABT-199 during this study.~   "
83070|NCT01969682|"~     This is an open-label multicenter, study to assess the pharmacokinetic interaction of~     rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's~     lymphoma.~   "
83071|NCT01970137|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of~     KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)~   "
83072|NCT01970124|"~     The purpose of this study is to evaluate the long-term safety, efficacy, and~     pharmacokinetics of KPS-0373 in SCD patients~   "
83073|NCT01970111|"~     The purpose of this study is to evaluate the long-term safety, efficacy, and~     pharmacokinetics of KPS-0373 in SCD patients.~   "
83074|NCT01970098|"~     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and~     evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.~   "
83075|NCT01970072|"~     The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics~     and safety of Remimazolam Tosylate with midazolam in healthy volunteers~   "
83076|NCT01970059|"~     The aim of present study is to evaluate the efficacy and safety of Extended-Release~     Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension~   "
83077|NCT01970046|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the~     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2~     Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control~   "
83082|NCT01969981|"~     This is a prospective, single center, observational study. Patients who require a Peripheral~     Inserted Central Catheters (PICC) will constitute the study population.~      The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the~     total placement of PICC and confirmation of tip of PICC placement and if this method can be~     conducted safely and efficiently.~      Patients will be included during a 6-month period as well as they are ambulatory or~     hospitalized. The patient's routine care will not be modified and only PICC will be assessed~     in the present study.~      PICC placement will be performed using the Site Rite guidance and tip position will be~     confirmed using the Sherlock 3CG.~      The procedure is the same as the routine habits of the operator (nurse or anesthesiologist);~     the vascular access team already uses the previous device for CVC placement.~      Patients won't be followed up in the study.~   "
83083|NCT01969968|"~     1. To study the kinetics of release after bariatric surgery of selected polluants stored~          in adipose tissue, looking for clinical and/or predictive factors~        2. To test the hypothesis of a deleterious effect of this release on the expected~          improvement of insulin-resistance and on the liver inflammation.~        3. To determine the level of contamination of morbidly obese patients, with or without~          metabolic syndrome, compared to a control, non obese population, with special attention~          to clinical (age, gender, reproductive history, pregnancy, nursing) and biological~          parameters (insulin-resistance, inflammation).~   "
83084|NCT01969955|"~     The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in~     previously treated advanced or metastatic squamous lung cancer.~   "
83085|NCT01969942|"~     The purpose of this study is to examine the toxicity of using allogeneic stem cell~     transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES).~     Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR,~     DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for~     Transplant for Donors to match with recipient]) matched related or unrelated donors.~     Specifically, we will examine:~        -  The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as~          related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).~        -  The incidence of transplant related mortality at 100 days.~   "
83086|NCT01969929|"~     To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by~     a laser flare-cell meter in 20G versus 23G vitrectomy.~   "
83087|NCT01969916|"~     Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during~     vasodilator stress can accurately identify patients presenting at the emergency department~     with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid~     in the identification of individuals most likely to benefit from revascularization, and thus~     improve the ability to predict patient outcomes.~      Our goals are:~        1. to test the above hypothesis by comparing stress MDCT perfusion data with invasive~          fractional flow reserve (FFR) data in patients with significant stenosis who undergo~          ICA;~        2. to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting~          patient outcomes.~   "
83088|NCT01969903|"~     The purpose of this study is to find out the proper amount of a drug called dexmedetomidine~     added to the local anesthetic drug called lidocaine to prolong the time and effect of pain~     relief provided for surgery.~      Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA)~     and indicated for sedation (calming effect). It has both pain relieving and calming effects~     when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to~     lidocaine decreased blood pressure and heart rate. The investigators plan to study the~     effect of lower amounts of dexmedetomidine to achieve the same level and duration of pain~     relief without reduction of blood pressure and heart rate.~   "
83089|NCT01969890|"~     The purpose of this study is to demonstrate that granulocyte colony-stimulating factor~     (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non~     pharmacological) is safe and significantly improves clinical outcome in patients with~     reduced left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for~     large anterior acute myocardial infarction.~   "
83090|NCT01969877|"~     The primary endpoint in this study is to investigate if there is a difference in overall~     survival in patients with locally advanced head and neck cancer, randomized to either~     radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is~     performed in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.~   "
83091|NCT01969864|"~     The purpose of this study is to determine the effect of brief organ donation video~     interventions on consent for organ donation among college and university students. Our~     hypothesis is that the organ donation video interventions will be superior to lay health~     websites for increasing organ donation consent.~   "
83092|NCT01969851|"~     SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in~     children with epilepsy syndromes associated with generalized seizures. LCM will be added to~     current antiepileptic treatment.~   "
83093|NCT01969838|"~     This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in~     participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential~     thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a~     Janus kinase inhibitor (JAK inhibitor).~      Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a~     double-blind treatment phase, after which they will be eligible to receive open-label MMB~     for up to an additional 168 weeks. After discontinuation of study medication, assessments~     will continue for 12 additional weeks, after which participants will be contacted for~     survival follow-up approximately every 6 months for up to 5 years from the date of~     enrollment.~   "
83094|NCT01969825|"~     The purpose of this prospective, randomized study, was to determine if neck and shoulder~     massage performed within 15 minutes of semen sample collection will increase the semen~     volume, and therefore increase the total motile sperm available for insemination as a result~     of decreased stress.~   "
83095|NCT01969812|"~     The purpose of this study is to determine patient satisfaction and tolerability of the Evie®~     slow-release insemination device for US population. Additionally, to assess cramping with~     the device and to determine pregnancy rates using the slow insemination device compared to~     standard IUI.~   "
83098|NCT01969773|"~     This study was designed in a multicenter, randomized, double-blind, placebo controlled trial~     to test the actual therapeutic effects of intravesical BoNTA injection. The results of this~     study might provide clinical evidence for a better therapeutic regimen in the treatment of~     IC/PBS.~   "
83099|NCT01969760|"~     The purpose of this study is to examine the feasibility and acceptability of a family-based~     program to improve physical activity and tobacco outcomes in a small pilot of middle school~     students and their families.~   "
83100|NCT01969669|"~     This is an open-label multicenter, study to assess the pharmacokinetic interaction of~     ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's~     lymphoma.~   "
83101|NCT01969656|"~     Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28~     days in healthy normal postmenopausal women.~   "
83102|NCT01969643|"~     This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic~     breast cancer. Increasing doses of SGN-LIV1A will be given every 3 weeks alone or in~     combination with trastuzumab.~   "
83103|NCT01969630|"~     To determine in patients with symptomatic femoropopliteal lesions whether percutaneous~     revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol~     stent is superior with respect to the 12-month incidence of restenosis compared to treatment~     with systematic paclitaxel-eluting stent (PES) angioplasty~   "
83104|NCT01969617|"~     To contribute to the understanding of the underlying neurobiological mechanism behind the~     interaction of alcohol and nalmefene~   "
83105|NCT01969604|"~     Background:~      In recent years there has been a growing interest in sedentary behaviour defined as~     activities performed in sitting or lying position during waking hours. Sedentary behaviour~     has been recognised as an independent risk factor for cardiovascular diseases and mortality.~     A few intervention studies in older sedentary people and in overweight or obese adults have~     demonstrated, that daily sitting time can be reduced through behavioural intervention.~      Patients with rheumatoid arthritis (RA) have an increased risk for cardiovascular diseases,~     partly caused by the rheumatic disease itself but also because of physical inactivity.~     Studies have documented a positive effect of increasing physical activity on pain and~     physical functioning in patients with RA. However, the studies also show, that the patients~     find it difficult to maintain the increased physical activity levels over time. Previous~     studies suggest that in promoting health among patients with mobility disability should not~     solely focus on increasing moderate to vigorous physical activity but also target reduction~     of sedentary behaviour and increase of light physical activity. In the present study we will~     focus on reduction of daily sitting time and increase of light physical activity as this~     approach may prove more feasible for patients with RA.~      Objectives and hypothesises:~      We hypothesise, that sedentary behaviour can be reduced in patients with RA through a~     behavioural lifestyle change. In addition, we hypothesize, that reduction of daily sitting~     time can have a positive effect on symptoms and general health in patients with RA.~      The primary objective of the present intervention study is to investigate the effect of a~     motivational counselling intervention on daily sitting time in adult men and women with RA.~     Furthermore we want to investigate whether a reduction in daily sitting time is related to~     reduction in pain and fatigue, reduced weight and waist circumference and improved quality~     of life, physical function and improved cardiovascular biomarker levels (cholesterol and~     blood pressure).~      Study setting and allocation:~      In total, 150 participants will be recruited from the rheumatology outpatient clinic at~     Glostrup University Hospital, Denmark. The participants will be allocated to either an~     intervention group (75) or a control group (75).~      Intervention:~      The intervention aims to support and strengthen the participants' belief in their own~     ability to reduce their daily sitting time. The intervention will include 1) three~     individual motivational counselling sessions (60-90 minutes), conducted by one of four~     project nurses in combination with 2)Individual Short Text Messages (SMS). The counselling~     sessions will focus on information about the positive health effects of reducing daily~     sitting time and the participants' own goals of reducing their sitting time. Based on the~     goals the participants will receive weekly SMS reminders.~      Data collection:~      Measurements on all participants will be done four times during 22 months; 1) at baseline,~     2) 16 weeks after start (by the end of the intervention), 3) six months after end of~     intervention and 4) 18 months after end of intervention. At each of the four visits the~     participants fill in questionnaires regarding demographics, lifestyle, daily sitting time,~     physical activity, physical function, pain , fatigue and quality of life. Furthermore, two~     occupational therapists will measure the participants' blood pressure, height, weight and~     waist circumference. At the same time a little monitor will be placed on the participants'~     thigh, which they will carry for seven days. The monitor measures the participants' physical~     activity level. The four measurements also include a blood sample from the participants in~     order to measure cholesterol levels.~   "
83106|NCT01969591|"~     To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic~     surgery.~   "
83107|NCT01969578|"~     Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached~     by multidisciplinary teams in high specialized centers. Until today no standard of care~     exists to treat these cancers. The identification of a target, the androgen receptor, in SG~     tumors has allowed for new treatment strategies options for this rare group of diseases. As~     a matter of fact, strong positivity for androgen expression has been found in salivary duct~     carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the~     efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients~     with recurrent and/or metastatic AR expressing SGCs.~      The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve~     patients, and Cohort B, which comprises pretreated patients.~   "
83108|NCT01969565|"~     The purpose of this study is to evaluate the safety and tolerability of increasing doses of~     carfilzomib in combination with dexamethasone~   "
83109|NCT01969552|"~     TSH plays a central role in current thyroid function testing both as a diagnostic tool and~     therapeutic target. Recent studies have suggested a more complex and hierarchical~     relationship between logTSH and FT4 over the entire functional spectrum than the widely~     assumed single log linear gradient (1-4). Our group has also shown a disjoint between~     pituitary TSH and FT3 serum levels being operative under conditions of levothyroxine~     monotherapy (5).~      The present prospective observational study aims at confirming some of these findings and~     exploring additional factors other than TSH that may be important in shaping the~     interrelation of thyroid parameters and modulating thyroidal activity in health and disease.~      To this purpose, unselected patients presenting for thyroid testing or treatment to a~     specialised unit at a teaching hospital will be prospectively studied to assess the~     interplay of FT3, FT4 and TSH under various conditions, and to evaluate various thyroidal~     and non-thyroidal influences, such as disease entity, thyroid volume, deiodinase activity,~     thyroid medication, surgery, radioiodine treatment, age, BMI, smoking on pituitary set-point~     and homeostatic equilibria.~   "
83110|NCT01969539|"~     The general aim of this 1-day, open label, non-randomised, trial is to characterize the~     performance of two adapter devices designed to permit use of the Respimat® inhaler with~     patients requiring mechanical ventilation.~   "
83111|NCT01969526|"~     Objective: To evaluate the effectiveness of a multifactorial intervention program based on~     physical activity and diet, memory workshops and review of medication, to modify frailty~     parameters, muscle strength and physical and cognitive performance in people 65 years or~     older with a positive screening for frailty. Secondly, to assess changes in falls,~     hospitalizations, nutritional risk, disability and institutionalization or home-care.~      Methods: randomized clinical trial with a control group, of one year and a half of~     follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included~     are 65 years or older with positive frailty screening, timed get-up-and-go less than or~     equal to 20 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will~     be selected in each group (difference to be detected on physical performance (Short physical~     performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to~     follow-up).~      Intervention: consists in three different actions on frailty dimensions, applied to each~     subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus~     intake of hyperproteic shakes, memory workshop and review of the medication.~      Evaluations will be blinded and conducted at 0, 3, 12 and 18 months. Analysis of variance~     for repeated measures to adjust for differences attributable to intervention effect and for~     potential confounders such as comorbidity, sensory limitations, social risk, other medical~     or social interventions, among others.~   "
83120|NCT01969409|"~     Recent research studies have suggested that proteins called antibodies that are produced by~     the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis~     (IPF). Antibodies produced by the immune system normal help to fight infections by attacking~     bacteria and viruses without harming our own tissues. In patients with IPF, there is~     evidence that certain antibodies (called autoantibodies) attack the lung and contributes to~     the injury and scarring that occurs in IPF. Our recent studies have found that many IPF~     patients appear to have excessive autoantibody levels in blood and lungs that might make~     their disease worse.~      Rituximab is a medication approved by the Food and Drug Administration (FDA) for the~     treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by~     destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce~     autoantibodies. In this research study, rituximab will be given into a vein to reduce the~     autoantibody levels that we believe might be contributing to the lung damage in IPF.~      This study is being conducted to determine if rituximab provides beneficial effects for IPF~     patients by decreasing further lung injury.~   "
83112|NCT01969513|"~     Vertigo is a common medical issue with a broad expectrum of diagnoses that requires a global~     approach to patients through structured clinical interview and physical examination. The~     main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV) that is~     confirmed by a positive Dix-Hallpike positional test and treated with repositioning~     manoeuvres. Objective: To evaluate the effectiveness of Epley's manoeuvre performed by~     general practitioners (GPs) in the treatment of BPPV. Design: randomized clinical trial~     conducted in primary care. Scope: Two urban centres serving about 50,000 patients. Patients:~     All patients with newly diagnosed BPPV will be offered to participate in the study and will~     be randomly assigned to the treatment group (Epley manoeuvre) or control group (sham~     manoeuvre) and both groups will receive betahistine. Outcome variables will be: response to~     the Dix Hallpike test, patients will inform if vertigo was present during the last week~     (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert scale in the past~     week, score of Vertigo Handicap Inventory and quantity of betahistine taken. Statistical~     analysis: Descriptive statistics of all variables collected. Groups will be compared using~     the intent-to-treat approach and either parametric or nonparametric tests depending on the~     nature and distribution of the variables. Chi-square test or exact Fisher test will be used~     to compare qualitative measures and Student's t test o Mann Whitney U test will be used for~     between-group comparison of variables.~      Positive results from our study will highlight that treatment of BPPV can be performed by~     trained GPs and its widespread practice can greatly improve the quality of life of these~     patients.~   "
83113|NCT01969500|"~     The goal of the proposed project is to develop and pilot a mobile Self-Management of~     Schizophrenia (SOS) system that will administer interventions targeting persistent symptoms~     of psychosis, social dysfunction, and poor medication adherence, with the long-term goal of~     creating a widely-available system that can be deployed by users as needed, in their own~     environments. The hypothesis is that this intervention group will show stronger improvement~     in the areas of psychiatric systems, social function, and medication adherence compared to~     treatment as usual.~   "
83114|NCT01969487|"~     Surgical residents and fellows acquire operative knowledge and skills by assisting attending~     surgeons in the operating room. Previous research has shown that practising technical skills~     prior to operating on patients can improve how skillfully laparoscopic surgery can be~     performed. Although an increasingly large number of patients are undergoing robotic~     hysterectomy and other robotic surgical procedures, little is known on how to ensure patient~     safety and treatment effectiveness when trainee surgeons participate in the operating room.~     Our study aims to determine the impact of immediate preoperative warm-up on a robotic~     surgery simulator by gynecologic surgical trainees on their intraoperative performance and~     on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees~     at a major academic medical center to either warm-up immediately before surgery on a robotic~     surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the~     operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The~     investigators will compare standard robotic surgical skills assessments of the trainees by~     the supervising attending surgeons and patient outcomes in the two groups.~   "
83115|NCT01969474|"~     The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as~     experienced by the patients.~   "
83116|NCT01969461|"~     Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease~     progression. Antiretroviral therapy (ART) is the single most important treatment for people~     living with HIV. However, ART adherence is suboptimal among adolescents and young adults~     living with HIV, the age group with the fastest growing rates of HIV infection, and great~     risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the~     effectiveness of home-based versus clinic-based Healthy Choices, a brief, 4- session~     intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication~     adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures~     design. Unlike previous trials, Healthy Choices will be tested in a real world clinical~     setting and be delivered by community health workers (CHW: already members of the HIV care~     team). The study population will consist of YLH, ages 16-24, who are current patients at 5~     ATN sites. Site staff will recruit potential participants. Youth will be randomized to~     receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both~     conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for~     biological measures will be through medical record extraction, and self-reported measures~     will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on~     an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and~     investigators will support local supervisors during the active intervention phase. We will~     conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of~     the trial to obtain information about barriers and facilitators of implementation. Thus, the~     proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to~     pilot a sustainable model of MI implementation in real-world youth care settings towards the~     goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an~     efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care~     settings; 2) gathering information about who responds under what contexts; and 3) increasing~     our understanding of the barriers and facilitators for future implementation. The primary~     hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol~     use and viral load than YLH receiving clinic-based MET.~   "
83117|NCT01969448|"~     The primary hypothesis of this study is to determine which of two incision sites~     (inframammary fold incision or the lateral radial incision) provides a more robust blood~     supply to the skin envelope during nipple-sparing mastectomy with immediate reconstruction.~      Following education about the trial and informed consent, patients will be randomized to one~     of the two incisions. If their surgeon recommends a particular incision, there is also a~     non-randomized cohort. Patients will complete the Breast Q, a questionnaire prior to surgery~     and three months after surgery to capture quality of life data. During the surgery,~     laser-assisted fluorescent angiography will be performed three times to look at blood~     perfusion with the Spy Elite imaging device.~      Patients will be required to return for postoperative follow up visits. All patients will be~     seen approximately one week, three weeks, and six weeks after surgery. Patients with a~     direct implant will finish the study at their three month post-operative visit. Patients~     with an expander will finish the study three months after their final implant is placed.~   "
83118|NCT01969435|"~     Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan~     HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for~     myeloablative conditioning in lymphoma patients undergoing ASCT~   "
83119|NCT01969422|"~     Comparison of online question-answering system and conventional consultation for~     dermatological questions:~        -  same diagnosis?~        -  same information, which had been collected?~        -  same recommendations about treatment?~        -  what were the relevant differences of the two?~   "
83121|NCT01969396|"~     To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.~   "
83122|NCT01969383|"~     Muscle activity in the aquatic environment was investigated while performing different~     exercises by electromyography analysis, due to conflicting results in the literature in~     relation to the floor. This study evaluated and compared the electrical activity of the~     rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and~     knee extension exercises with and without load.~   "
83123|NCT01969370|"~     This study is part of a larger consortium project investigating the validity and best use of~     next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care.~     This sub-project is investigating benefits and harms of providing WES diagnostic and~     different types of incidental findings to adult patients and parents of pediatric patients~     who undergo WES because they have symptoms suggesting genetic disease.~   "
83124|NCT01969357|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the~     effective dose range of SP2086 in Patients with type 2 diabetes.~   "
83125|NCT01969344|"~     The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD),~     which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD,~     and it is the fourth leading cause of death in the country. The most common cause of COPD is~     cigarette smoking, although not all smokers get COPD. The discovery of new treatments for~     COPD has been slowed by a poor understanding of different types of COPD and a lack of ways~     to measure whether or not COPD is getting worse.~      The study has two main goals. The first is to find groups of patients with COPD who share~     certain characteristics. Certain groups may respond differently to certain treatments. The~     second is to find new ways of measuring whether or not COPD is getting worse. This would~     provide new ways of testing whether a new treatment is working.~      SPIROMICS has three substudies and two ancillary studies.~      Substudies:~        1. Repeatability Substudy: The entire baseline clinic visit will be repeated on 100~          volunteers. The goal of this substudy is to determine reliability of measurement~          procedures.~        2. Bronchoscopy Substudy: 300 participants will be enrolled for two additional study~          visits, including a bronchoscopy. The goal of this substudy is to collect and assess~          biological specimens and relate those results to clinical measurements.~        3. Exacerbation Substudy: Up to 400 participants will be enrolled in this substudy. A~          daily symptom diary will be collected on all participants. Participants will also be~          seen in the clinic during a pulmonary exacerbation. The goals of this substudy are to~          1) better understand the relationship between symptoms and exacerbations and 2) obtain~          clinical data and specimens during a pulmonary exacerbation.~      Ancillary Studies:~        1. Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study uses~          state-of-the art air pollution exposure assessments to determine individual-level~          outdoor and indoor air pollution exposure. The goals of this substudy are to determine~          the effect of long-term air pollution exposure on COPD morbidity and to determine~          whether short-term changes in outdoor air pollution are associated with changes in COPD~          morbidity.~        2. Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD~          ancillary study collects an additional CT scan during the final study visit and uses a~          new analysis technique (PRM) to assess the functional small airways of the lung and~          emphysema.~   "
83126|NCT01969331|"~     The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an~     add-on therapy in treatment of H. Pylori infection with the standard triple therapy~     approach.~      The primary objective in the study is determination of efficacy of Normia® probiotic as a~     supportive therapy in achieving a higher percentage of eradication of H. Pylori.~      The secondary objectives are to assess:~        -  Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of~          side-effects and better compliance to the eradication therapy~        -  Safety and efficacy of Normia® probiotic in different demographic subgroups~   "
83127|NCT01969318|"~     SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the~     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2~     Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control~   "
83128|NCT01969305|"~     This pilot study will adapt and test the feasibility and estimate the effect size parameters~     of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to~     reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females~     and males living in communities highly affected by heroin trade and use in Almaty,~     Kazakhstan.~   "
83129|NCT01969292|"~     Our team has created an automated, real-time software based image analysis tool called~     Colometer to improve screening colonoscopy providing real time visual feedback on image~     quality. There are three components to this study. The first is to validate the bowel~     assessment preparation using the recorded colonoscopy videos from 50 consented normal risk~     patients. In the second phase, technological and machine user interface refinements will be~     identified and completed. Finally, the third phase will be a sham controlled prospective~     study of Colometer versus standard care in 100 consented average risk patients undergoing~     screening colonoscopy as performed by 10 consented endoscopists.~   "
83130|NCT01969279|"~     Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic~     fractures, there are concerns that these medications may be associated with rare atypical~     femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and~     AFF is unclear. In this study, the investigators would like to analyze the long term effects~     on femur by bisphosphonate treatment.The participants are treated in the investigators~     hospital more than four years.~   "
83131|NCT01969266|"~     The purpose of this study is to examine the exposure and safety of a supratherapeutic dose~     of PCI-32765 (ibrutinib) in healthy adult volunteers.~   "
83132|NCT01969253|"~     Over the past few years, several studies have been made on various outcomes about the~     incidence of lymphedema. Because the outcomes can be came out differently each study by~     measurement, criteria, treatment period, treatment method and morbid extremities of~     lymphedema. Therefore it is required for understanding about the incidence, risk factor and~     physical progress for to be treated and prevented of lymphedema. Also it is necessary that~     to understand characteristics of lymphedema measurements and to establish diagnostic~     criteria of lymphedema through comparative study.~      The aim of this study was to analyze the incidence and risk factor of lymphedema through~     prospectively observation, and to determine effects on the quality of life of lymphedema~     after breast cancer surgery with ALND.~   "
83133|NCT01969240|"~     Our long-term goal is to promote evidence-based patient-centered evaluation in the acute~     setting to more closely tailor testing to disease risk. To compare the use of risk~     stratification tools with usual clinical approaches to treatment selection or~     administration, we propose the following:~        1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures~          in a pragmatic parallel patient randomized trial.~           Hypothesis: The intervention will significantly increase patient knowledge, engagement,~          and satisfaction with no increase in adverse events.~        2. Test if the decision aid has an effect on healthcare utilization within 30 days after~          enrollment.~      Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate~     of cardiac testing, and total healthcare utilization.~   "
84193|NCT01955356|"~     Some studies have revealed that an induced endometrial injury could improve embryo human~     implantation in patients with implantation failure.~      The purpose of this study is to determine whether the induced endometrial injury could be~     beneficial for regular patients undergoing IVF~   "
83134|NCT01969227|"~     Maintaining the patency of upper airway in sedated and anesthetized patients is challenging~     especially when patients are ready to be weaned from mechanical ventilation. Impairment of~     airway patency is a common cause of extubation failure and opioids and hypnotics can~     adversely affect airway patency.~      Ketamine, a noncompetitive antagonist of N-methyl-D- aspartate (NMDA), unlike other~     anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic~     plasma concentration, ketamine reduces both opioid and propofol requirements. Recent animal~     data suggests that when added to propofol in a sedation regimen, ketamine decreased~     hypoventilation when compared to propofol alone because ketamine can increase genioglossus~     phasic activity while abolishing the coupling between loss of consciousness and upper airway~     dilator muscle activity. However, this relationship has not been examined in human in~     combination of other drugs.~      The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of~     ketamine on breathing and electroencephalography in mechanical ventilated patients.~     Spirometry will be utilized to evaluate upper airway patency. Polysomnography (PSG- Alice~     PDx) will be used to evaluate the effects of ketamine on EEG during wakefulness and sleep.~     An esophageal balloon will be inserted to measure esophageal pressure, which enables us to~     measure the effects of ketamine on transpulmonary pressure. A volumetric capnography, NICO~     noninvasive device from Respironics will be used to measure anatomical dead space, CO2~     production, mean expiratory CO2 and slope of the alveolar plateau of the volumetric~     capnogram~   "
83135|NCT01969214|"~     Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several~     studies demonstrating their efficacy, the investigators are conducting this study to look~     into the efficacy and safety of IQP-MM-101 in diarrhoea control.~   "
83136|NCT01969201|"~     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety~     of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled~     ovarian hyperstimulation in a GnRH-antagonist cycle.~   "
83137|NCT01969188|"~     Spondyloarthritis refers to a set of inflammatory disorders that mainly afflict the spine,~     joints and ligaments. A subtype of spondyloarthritis is Ankylosing Spondylitis - now known~     as axial spondyloarthropathy - which is characterized by inflammation of the joints in the~     spinal column, and the part of the back where the spine meets the pelvis. Another subtype of~     spondyloarthritis is Psoriatic Arthritis where patients often develop raised patches of~     reddened skin. The disease can advance to one of more joints in the body resulting in pain,~     swelling and stiffness. These forms of inflammatory arthritis can become chronic and over~     time can lead to pain, disability and deformity.~      There is now evidence that patients with inflammatory arthritis that are diagnosed and~     treated earlier in the course of their symptoms may have better results. Yet although we~     know that early treatment is important, the investigators still don't know if there are~     factors that can predict how an individual patient's disease will progress over time in~     terms of losing mobility. The investigators also do not know the relationship between~     loosing mobility and the formation of bone around the spine and joints.~      The investigators are doing this study because the investigators want to learn more about~     patients with these forms of arthritis - Ankylosing Spondylitis and Psoriatic Arthritis. The~     investigators want to learn more about the factors that can predict how their disease might~     progress over time and what their response to treatment might be. The investigators would~     also like to determine the proportion of patients with these types of symptoms and describe~     the best treatment strategies for them.~   "
83138|NCT01969175|"~     The objective of this study is to assess the effect of a low-glycemic-load and milk-free~     diet on acne severity.~      IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both~     groups to explore the mTORC signaling pathway, which is thought to be related to clinical~     improvement in previous studies.~   "
83139|NCT01969162|"~     This exploratory study will collect tear samples from adult volunteers for determining and~     quantifying tear composition profiles. No investigational drug will be administered in this~     study.~   "
83140|NCT01969149|"~     Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and~     non diabetic patients.~      It has been shown that perioperative hyperglycemia is an independent risk factor of~     postoperative mortality and morbidity.~      The Leuven et al.'s study suggested that strict glycemic perioperative control using an~     intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's~     patients. This study included a majority of cardiac surgery patients. Others studies have~     suggested that the beneficial effect of insulin-based tight perioperative glycemic control~     might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain~     perioperative glycemic stability in most patients.~      Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect~     that depends on the blood glucose level.~      We hypothesize that continuous intravenous infusion of exenatide could improve perioperative~     glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared~     to a conventional insulin therapy during the perioperative period of cardiac surgery.~   "
83141|NCT01969136|"~     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of~     EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's~     disease currently receiving stable treatment or previously treated with an~     acetylcholinesterase inhibitor.~   "
83142|NCT01969123|"~     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of~     EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's~     disease currently receiving stable treatment or previously treated with an~     acetylcholinesterase inhibitor.~   "
83143|NCT01969110|"~     The purpose of this study is to investigate whether perioperative immunonutrition has~     additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.~   "
83144|NCT01969097|"~     The aim of the study is to investigate whether the combination of bihemispheric (dual)~     transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days~     facilitates motor recovery in chronic stroke. Results will be compared to a matched group of~     patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional~     and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3~     month follow-up will help investigating neural correlates of expected changes in motor~     function of the affected upper extremity.~   "
83145|NCT01969084|"~     Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug,~     treatment on inflammation as well as vascular and mitochondrial function in diabetic~     patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state,~     improve endothelial function, increase the blood flow at the muscle microcirculation level~     and improve mitochondrial function. In this study, investigators will perform tests that~     evaluate the function of small and large blood vessels by employing ultrasound and laser~     doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the~     lower extremity muscles at rest and during exercise will also be employed. Forty subjects~     with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly~     assigned to receive linagliptin while the other half will receive placebo. All tests will be~     performed at the beginning and the end of the study.~   "
83146|NCT01969071|"~     The effects of levosimendan on renal function in patients with low ejection fraction~     undergoing mitral valve surgery will be investigated in a prospective, double-blinded,~     randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values,~     calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative~     clinical follow-up parameters.~   "
83147|NCT01969058|"~     This phase II study is being done in HIV-infected subjects on antiretroviral therapy to~     evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of~     severe acne) on the immune system. Your immune system helps your body fight infections. When~     your immune system is not working well, you may be at greater risk for diseases that are~     common in aging, like heart disease, weaker bones, and kidney disease.~   "
83148|NCT01969045|"~     The aim of this prospective study is to examine the benefits und risks of administration of~     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)~     during flexible bronchoscopy.~   "
83149|NCT01969032|"~     The purpose of this study is to increase survival of patients with locally advanced~     triple-negative breast cancer using two consequent induction preoperative chemotherapy~     regimens.~   "
83150|NCT01969019|"~     This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12~     weeks and 4 weeks.~   "
83151|NCT01969006|"~     This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ %~     Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after~     laparoscopic inguinal hernia repair.~      Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.~      Pain will be estimated using the VAS score in:~      1. the wound 2 the abdomen 3 the shoulder~      Scoring will be performed:~        1. pre-operatively~        2. 1 hour postoperatively~        3. at discharge from the hospital d day 1,2 and 3 post OP~      e. 1 year post OP~   "
83152|NCT01968993|"~     nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare~     fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone~     and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the~     treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion~     at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational~     motion, and less than 5 degrees of angular motion.~   "
83153|NCT01968980|"~     This is a multicenter, randomized study in subjects with heterozygous familial~     hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and~     tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.~   "
83154|NCT01968967|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab~     (PF-04950615;RN316) to lower LDL-C.~   "
83155|NCT01968954|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab~     (PF-04950615;RN316) to lower LDL-C.~   "
83156|NCT01968941|"~     A multi-centre randomized controlled open-label trial in medically inoperable patients with~     biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting~     patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or~     conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as~     possible following randomization and subjects will be followed for 5 years~     post-randomization for cancer recurrence, toxicity and survival. The primary outcome is~     local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.~   "
83157|NCT01968928|"~     Bladder urothelial carcinoma (UC) is a common malignancy and the incidence is increasing by~     years in Taiwan. Chemoresistance was inevitable in treatment of metastatic disease and lead~     to the ominous outcomes. To develop novel therapeutic strategies to overcome chemoresistance~     is imperative. Cancer cells uptake glucose at higher rates than normal tissue but use most~     of glucose for glycolysis even under normoxia condition, which is known as the Warburg~     effect. Pyruvate kinase (PK) catalyzes the last step in the process of glycolysis, and one~     of it isoform--PKM2 has been reported to be associated with tumor progression and some~     specific tissues and promotes the Warburg effect in cancer cells.~   "
83158|NCT01968915|"~     This study will evaluate safety and tolerability to estimate the maximum tolerated dose~     and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.~   "
83159|NCT01968902|"~     The purpose of this study is to determine if Xeomin® will prove effective for significantly~     improving lower extremity spasticity and will be well tolerated by the majority of MS~     patients.~   "
83160|NCT01968889|"~     Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a~     deep weakness involving the respiratory muscle work which result in a delayed weaning of~     mechanical ventilation.~      The main objective is to quantify the loss of diaphragm function by measuring the diaphragm~     force (using the non invasive method by phrenic nerve stimulation allowing to measure the~     twitch airway pressure during airway occlusion) in a selected population of patients with~     critical illness neuromyopathy (defined as a MRC score < 48).~      The second end points are to evaluate its incidence, the consequences on the patients~     outcome (extubation success or failure; ICU stay) and to evaluate the relations between~     diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory~     pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force~     (evaluated by the Medical Research Council - MRC score).~   "
83161|NCT01968876|"~     This research will act as a pilot study that will be conducted to determine the~     effectiveness of a smartphone medication adherence application on adherence to oral~     hypertensive, diabetic, and dyslipidemic medications using a prospective randomized design.~     Subjects will be recruited from the University of Arkansas for Medical Sciences (UAMS)~     Internal Medicine Clinic North, and the study data will be collected using only subject~     self-reports and subject pharmacy records.~   "
83162|NCT01968863|"~     The overall objective of this exploratory, laboratory study is to evaluate whether~     noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in~     detecting dysplastic (precancerous) areas during standard surveillance. This is a study~     designed to evaluate the feasibility of using prototype imaging technology to enhance the~     detection of precancerous changes in various tissues. The results of this laboratory study~     will be used to further develop the technology for clinical application.~      The primary aim of this project will be to investigate what digital image analysis criteria~     can be used to best detect dysplasia in various types of resected tissue.~   "
83163|NCT01968850|"~     This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone~     anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30)~     treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be~     randomized in a 1:1:1 fashion to one of the following three arms:~        1. no bone anti-resorptive therapy (standard of care)~        2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;~        3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D~      Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory~     evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary~     objective will involve calculation of σ and ρ using all data; δ will be estimated by~     comparing the two alendronate arms pooled to the no-treatment arm.~   "
83164|NCT01968837|"~     Although highly curable, cervical cancer kills thousands of women in developing countries~     annually. The investigators will pilot a project to improve detection of cervical cancer in~     Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise~     available in a large medical centre and remote use of a mobile phone camera application.~   "
83165|NCT01968824|"~     Despite the plethora of literature suggesting that regional blockade provides adequate~     andimproved postoperative pain control, function and improved intraoperative and~     postoperative safety in proximal upper extremity surgery, little is known of its benefits~     for the treatment of forearm and distal radius fractures . The purpose of this randomized,~     prospective, study is to determine if brachial plexus blockade with general anesthesia is~     superior to general anesthesia alone in immediate and long-term pain control in patients~     undergoing operative fixation of distal upper extremity fractures.~   "
83166|NCT01968811|"~     The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing~     Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to~     evaluate the dressing kit as part of a negative pressure system. The secondary objectives~     are to collect and evaluate safety data, performance data and information on technical~     complications.~   "
83167|NCT01968798|"~     The ASPREE Cancer Endpoint Study (ACES), an ancillary study of the ASPirin in the Prevention~     of Events in the Elderly (ASPREE) Study, will allow for the examination of the effect of~     daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected~     specific incident and recurrent cancer and metastases. The establishment of this ACES~     biobank will allow for the exploration of DNA-related molecular mechanisms of aspirin's~     protective effect against cancer, cancer associated mortality and metastases, using blood or~     saliva DNA specimens, urine, and tumor tissue.~   "
83168|NCT01968785|"~     The kidneys are an important regulator of blood pressure. Previous research has shown that~     disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In~     the past, one technique that was used to treat severe high blood pressure was a surgical~     procedure to cut these nerves. However, this surgery is no longer commonly performed.~      Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a~     small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is~     currently approved in the United States to deliver ion dose therapy to re-narrowings that~     form in the coronary arteries in the heart. This trial is assessing the safety of treating~     patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney~     to help control blood pressure in patients with uncontrolled hypertension.~        1. Renal artery brachytherapy with beta-emitting source is safe.~        2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic~          blood pressure via renal denervation mechanism within 6 months post treatment.~   "
83169|NCT01968772|"~     In this pilot study we propose to gather preliminary data on whether transdermal magnesium~     chloride can improve quality of life in patients with fibromyalgia. Forty women with~     fibromyalgia will be enrolled in this study. Participants will be asked to apply a topical~     solution of magnesium chloride on their extremities 3 times daily for 28 consecutive days.~     Three questionnaires measuring quality of life will be administered at baseline, at 2 weeks,~     and at 4 weeks (end of study).~   "
83170|NCT01968759|"~     Progressive renal impairment in chronic kidney diseases (CKD) may cause inability to excrete~     phosphate load, thus leading to the typical abnormalities of the mineral metabolism, such as~     increased phosphate and reduced calcium levels, 1,25- dihydroxyvitamin D deficiency and~     secondary hyperparathyroidism (HPT). Treatment with vitamin D analogues and/or phosphate~     binders ameliorates these abnormalities that are also associated with accelerated renal~     disease progression and increased cardiovascular risk. However in a post-hoc analysis of 331~     patients with proteinuric chronic nephropathies included in the Ramipril Efficacy In~     Nephropathy (REIN) trial, increasing serum phosphate levels at inclusion, even within the~     normal reference range, were associated with an incremental risk of progression to End Stage~     Renal Disease (ESRD). Moreover, increasing levels of serum phosphate were associated with a~     progressively decreasing protective effect of ramipril therapy against progression to ESRD,~     to the point that the benefit of Angiotensin-Converting-Enzyme (ACE) inhibition was almost~     fully lost among patients with serum phosphate levels exceeding 4.5 mg/dL. This finding~     provided convincing evidence that phosphate plays a direct pathogenic role in patients with~     progressive nephropathies and that excess phosphate exposure may limit or even blunt the~     renoprotective effect of ACE inhibitor therapy in this population.~      Sevelamer carbonate is a newly approved phosphate binder for chronic kidney disease (CKD)~     patients not yet on maintenance dialysis. Treatment with Sevelamer, in addition to correct~     hyperphosphatemia, was also found to ameliorate abnormalities of the mineral metabolism~     associated with accelerated renal disease progression and increased cardiovascular risk.~     Moreover, Sevelamer therapy reduces proteinuria in an animal model of uremia, an effect that~     in the long term might translate into significant renoprotection. These findings suggest~     that serum phosphate might be a specific target for renoprotective therapy in CKD patients~     and provide the background for randomized clinical trials to formally test whether reducing~     phosphate exposure by phosphate binding agents may serve to optimize the renoprotective~     effect of RAS inhibition in this population. Thus, whether phosphate reduction by Sevelamer~     carbonate therapy may have a specific antiproteinuric effect in humans with chronic~     nephropathies and residual proteinuria despite optimized RAS inhibitor therapy is worth~     investigating.~   "
83171|NCT01968746|"~     The overall objective of this study is to utilize heart rate variability and respiratory~     rate variability in patients with sepsis to predict clinical deterioration and death.~      Our specific objectives are:~        1. To study the ability of a change in composite variability (∆CVI) assessment to act as a~          prognostic aid in predicting disease progression in sepsis.~        2. To study the effect that standard resuscitation interventions will have on the~          direction and magnitude of ∆CVI in patients with sepsis.~      B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter~     composite variability index (CVI) over 4 hours will predict a significant increase in the~     combined outcome of overt shock, organ dysfunction, and mortality.~      H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over~     4 hours will be associated with a low or declining CVI.~   "
83172|NCT01968733|"~     This study will evaluate the safety and efficacy of an experimental antibiotic,~     solithromycin, in the treatment of adult patients with community-acquired pneumonia.~   "
83173|NCT01968720|"~     The purpose of this study is to determine the safety and efficacy of multiple doses of~     CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current~     therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total~     triglycerides and chylomicron triglyceride levels in patients with severe~     hypertriglyceridemia.~      This is a single-blind study. All patients will receive placebo for a 14 day treatment~     period and CAT-2003 for a 28 day treatment period.~   "
83174|NCT01968707|"~     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep~     on skin flora of the abdomen and inguinal regions of human subjects.~   "
83175|NCT01968694|"~     We are doing this research study to find out if intravenous (in your vein, IV) lidocaine~     can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved~     intravenous lidocaine to treat irregular heart beats, but the FDA has not approved~     intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used~     for more than 25 years to treat different acute and chronic pain conditions but has not yet~     been studied for endometriosis pain.~      This is a cross-over trial over two months where one month you will receive the active~     medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,~     commonly known as benadryl). We will compare the effect on pain from endometriosis of~     lidocaine to active placebo.~   "
83176|NCT01968681|"~     Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally~     treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor~     responders and do not get satisfactory results from pulsed dye laser treatments.~      Small studies with alexandrite lasers indicate that this may be an alternative treatment for~     individuals with nevus flammeus. This study assesses the clinical effect and side effects of~     alexandrite laser treatment for nevus flammeus using different treatment settings.~   "
83177|NCT01968668|"~     This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the~     clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive,~     double-blind, placebo-controlled, parallel-group design.~      Primary objective of the study is investigate the change of Urinary Albumin to Creatine~     Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from~     baseline to Visit 8 (Day 90)~   "
83178|NCT01968655|"~     To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious~     bleeding episode who do not have access to an active clinical study site associated with the~     OBI-1-301 study.~   "
83179|NCT01968642|"~     The utilization of transthoracic echocardiography in the United States has been increasing.~     This has resulted in increased costs to the healthcare system. In an effort to curb~     excessive utilization of this technology, the American College of Cardiology created~     Appropriate Use Criteria to help guide clinicians to use this diagnostic imaging modality~     more appropriately. The investigators previously showed that an educational intervention can~     reduce the rate of inappropriate echocardiograms ordered by physicians-in-training. It is~     unknown if such an intervention would be successful in attending, staff level of physicians.~     The investigators hypothesize that an educational and feedback intervention will reduce the~     rate of inappropriate outpatient transthoracic echocardiograms ordered by staff~     cardiologists and internal medicine physicians.~   "
83180|NCT01968629|"~     In this research study, the investigators are looking to see if MR imaging with Eovist~     performed 24 hours after the injection of Eovist helps improve the identification and~     characterization of focal liver tumors.~   "
83181|NCT01968616|"~     In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment~     have not been evaluated comprehensively. Therefore, we have planned to analyze predictors~     for visual outcome from a viewpoint of electrophysiology and biomarkers besides~     morphological features by SD-OCT.~   "
83182|NCT01968603|"~     The aim of the study was to describe postoperative weight change in adults undergoing~     surgery for craniopharyngioma and identify preoperative factors associated with it.~   "
83183|NCT01968590|"~     This clinical trial is conducted by one of 4 locations; University of British Columbia~     (Vancouver, CA), University of Utah (Salt Lake City, UT, USA), University of Cincinnati~     (Cincinnati, OH, USA), and University of Hamburg (Hamburg, Germany).~      Adults with NF1 have a higher risk of osteopenia and osteoporosis, a condition of low bone~     density that can lead to fragile bones and bone breakage.~      People with NF1 also have lower vitamin D levels than unaffected individuals. Vitamin D is~     important for normal bone health, but studies to improve bone health by vitamin D~     supplementation in people with NF1 have not been tried.~      The purpose of this study is to treat adults with NF1 who have insufficient serum vitamin D~     levels with 2 different doses of vitamin D supplementation to determine if vitamin D~     supplementation ameliorates the usual loss of bone mineral density over 2 years.~   "
83245|NCT01967784|"~     The aim of the study is to describe the immunogenicity and safety of the new formulation of~     Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere~     (NH) in subjects aged 9 to 17 years in Taiwan~      Primary Objective:~        -  To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal~          formulation~      Secondary Objective:~        -  To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation~   "
83184|NCT01968577|"~     Patients with stable coronary disease when undergoing percutaneous coronary intervention may~     present periprocedural myocardial infarction defined at present as a creatine~     kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off~     for periprocedural myocardial infarction after PCI. Although percutaneous coronary~     intervention is associated with low rates of complications, periprocedural myocardial~     infarction has been touted as a negative factor in long-term clinical results . Several~     clinical, anatomical and technical associate to the occurrence of this event . Although~     randomized controlled trials and systematic reviews to statin pre intervention have targeted~     the administration of high-dose statin is recommended before surgery to reduce the risk of~     periprocedural myocardial infarction, there is no information on the impact of the maximum~     concentration plasma of statin at the time of percutaneous coronary intervention in stable~     patients on chronic statin use in preventing periprocedural myocardial infarction or the~     elevation of cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary~     intervention was mainly determined in statin -naïve patients or in patients with acute~     coronary syndromes . In this work , we studied the impact of the peak plasma concentration~     of statin at the time of percutaneous coronary intervention was studied through prospective~     randomized single center in stable patients with chronic statin divided into two groups . In~     the group (1) Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin~     between one and six hours before surgery and group (2) control without rosuvastatin (n =~     268). This range 1 to 6 hours is the time at the peak concentration of rosuvastatin in the~     blood after oral ingestion. The primary objective was to assess the incidence of~     periprocedural myocardial infarction by creatine kinase above three times upper normal limit~     in hospital period and as a secondary objective to analyze the elevation of any amount of~     creatine kinase on the baseline.~   "
83185|NCT01968564|"~     The proposed study will assess the ability of curcumin, the active ingredient in the Indian~     spice tumeric, to improve the function of arteries with age. Overall, the proposed research~     project has the long-term potential to influence clinical practice guidelines by~     establishing a novel, easy to deliver, cost-effective therapy for treating age-associated~     arterial dysfunction and reducing the risk of cardiovascular disease with age.~   "
83186|NCT01968551|"~     The primary objective of this study is to evaluate the efficacy of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose~     combination (FDC) plus DRV relative to current antiretroviral regimens (ARV) in~     virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week~     24.~      This study consists of 48 weeks of open-label phase followed by an optional extension phase~     in which all the participants will receive E/C/F/TAF+DRV.~   "
83187|NCT01968538|"~     Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or~     hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances~     in omic analysis may offer additional information to the physician about prognosis and~     radiation response. We propose to establish a protocol to incorporate omic analysis into the~     evaluation and treatment of patients with prostate cancer.~   "
83188|NCT01968525|"~     1. Every individual receiving a general anesthetic is at potential risk for developing a~          ''cannot intubate-cannot ventilate'' situation following anesthetic induction.~        2. Building up of oxygen reserves assumes great significance as this provides a longer~          duration of non-hypoxic apnea should one be faced with an unanticipated difficult~          airway.~        3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to~          the peripheral tissues.~        4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb~          while arterial oxygenation and oxyhemoglobin saturation remain high.~        5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve~          the safety period of tracheal intubation.~        6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of~          anemia patients.~        7. The aim of this study was to assess the effect of chronic anemia on the duration of~          non-hypoxic apnoea during induction of anaesthesia.~   "
83189|NCT01968512|"~     Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder~     (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the~     adaptation of inhibitory control.~   "
83190|NCT01968499|"~     This registration study aims to investigate the associations of the pharmacogenetic and~     pharmacokinetic factors with clopidogrel low response and clinical outcome in patients with~     coronary artery disease, and provide new pharmacogenetic and pharmacokinetic targets for the~     individualized anti-platelet treatment.~   "
83191|NCT01968486|"~     To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin~     photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization~     secondary to pathologic myopia (PM).~   "
83192|NCT01968473|"~     The purpose of this study is to investigate issues relating to comfort and tolerance to~     surface neuro muscular electrical stimulation in a parkinson disease population.~   "
83193|NCT01968460|"~     This study will evaluate an oral fixed-dose, once daily product that combines pramipexole~     and rasagiline for the treatment of early Parkinson's disease.~      Animal studies support the therapeutic advantage of combining low doses of rasagiline and~     pramipexole and suggest further improvement when both are administered in a sustained~     fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's~     disease with a good safety profile. combining the drugs in low doses and controlled release~     may provide better symptom management than the existing drugs alone or together.~   "
83194|NCT01968447|"~     The purpose of this study is to study the effect of variations in the arterial CO2~     concentration during deep neuromuscular block on the surgical conditions as assessed by the~     surgical rating scale~   "
83195|NCT01968434|"~     The purpose of this study is to determine if there is comparable efficacy between~     carbocisteine and a protective cough syrup from natural ingredients in children's cough due~     to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that~     protecting the throat is very useful in decreasing cough severity, both day and night,~     without needing to subdue such an important reflex as cough, and without only acting on~     mucous fluidification, especially in children where sedation and excessive fluidification is~     dangerous. The research hypothesis is that the protective (GrinTuss) Syrup relieves cough~     (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the~     quality of sleep of the child) as much as or more than the carbocisteine syrup usually used~     to treat children (Syr Mucolyt).~   "
83246|NCT01967771|"~     This study will be a phase I, open label, three period, fixed sequence crossover study to~     evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of~     Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening~     visit within 30 days prior to the first dose of study drug, three treatment periods, and a~     follow-up visit 7-14 days after the last dose of study drug. There is no washout between~     treatment periods.~   "
85371|NCT01939977|"~     To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation~     (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D~     nutritional supplements (calcifediol) in patients with renal transplantation.~   "
83196|NCT01968421|"~     Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the~     medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation~     and infection. Bronchiectasis airways are often colonized with bacterial species. Infections~     of the airways are thought to play an important role in bronchiectasis exacerbation. The~     non-specific prevention of recurrent airway infections by immunostimulating agents has~     gained growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria~     important in respiratory infections, has shown the benefit for significantly reducing the~     incidence of exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of~     this study is to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation~     in Chinese patients (iPROBE).~      This study is designed as a prospective randomised double-blind placebo-controlled~     multi-centred trial.~   "
83197|NCT01968408|"~     AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for~     the prevention of nosocomial diarrhea.~      TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a~     daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery~     stools in a 24 h that will occur more than 72 h after admission).~   "
83198|NCT01968395|"~     The objective of this study is to conduct a population pharmacokinetic analysis of~     caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis~     or liver disease with Child-Pugh score B and C in order to better characterize~     pharmacokinetic parameters in case of moderate and severe liver dysfunction.~   "
83199|NCT01968382|"~     Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS~     antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters~     related to severe alcoholic hepatitis (SAH).~      IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.~      Aim: To perform a phase 2a proof of concept placebo-controlled, dose-ranging study of Imm~     124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH~     on steroids.~   "
83200|NCT01968369|"~     Several epidemiological and intervention studies suggest that a high dietary intake of~     tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is~     associated with an increased incidence of CVD. This beneficial effects have been attributed~     especially to lycopene, an antioxidant present in high concentration within tomatoes but~     other substances could be of importance.~      Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the~     present study is therefore to investigate whether consumption of tomato products ameliorates~     peripheral endothelial function, triggered by a high fat meal, in human volunteers in a~     randomised, crossover dietary intervention study.~      Study design:~      Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with~     or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During~     the week before the study all the subjects will be maintained in a low fibers diet and only~     subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr~     for 7 days= total load 560 mg).~      We hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on~     vascular function.~   "
83201|NCT01968356|"~     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep~     on skin flora of the abdomen and inguinal regions of human subjects.~   "
83202|NCT01968343|"~     Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and~     plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment.~     However, there have been no randomized, controlled studies of the efficacy of group~     cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a~     diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either~     group cognitive-behavioral therapy or group supportive therapy (control).~   "
83203|NCT01968330|"~     This study will be a randomized controlled trial involving obese women obtaining prenatal~     care at an obstetric care clinic. Study subjects will undergo prenatal care in a group~     setting or prenatal care with a behavioral intervention to improve sleep. Anthropometric~     measurements, blood draws, questionnaires and at home sleep studies will be completed at~     three specified times (two antepartum and one postpartum). Primary outcome will be a~     comparison of postpartum weight loss amongst the intervention and control groups.~   "
83204|NCT01968317|"~     The purpose of this study is to see if megestrol acetate plus metformin will be more~     effective in returning the endometrial tissue to a normal state than megestrol acetate alone~     in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.~   "
83205|NCT01968304|"~     In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30%~     to 90%, according to the series, disease stages, primary tumor locations and age (Scotte,~     Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency~     (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have~     never been assessed in a prospective study. It is well-known that anemia in the cancer~     setting is a source of asthenia and deterioration of quality of life, and can even reduce~     the efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore~     constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were~     treated with erythropoietin (EPO). However, prescriptions for EPO appear to have~     considerably declined since the warnings issued by various scientific societies and~     governments on account of the possible increase in death rates and a higher incidence of~     thromboembolic events, as reported in 8 studies published to date (NCCN 2012).~     Simultaneously, the transfusion rate augmented from 3.4% to 8.7% and the median hemoglobin~     level fell from 10.8 to 8.9 g/dL (Feinberg, Bruno et al. 2012). The use of injectable iron~     appears to have improved the correction of anemia by EPO, as reported in several concordant~     studies versus oral iron and placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al.~     2011). However, no monotherapy study has been conducted to evaluate the impact of injectable~     iron, alone without EPO, for the correction of ID (with or without anemia) in cancer~     treatment. Consequently, there exists a wide variety of practices, with an injectable iron~     prescription rate which, a priori, does not match the number of patients with iron~     deficiency. There exist other iron-based parameters to characterize ID but these are not yet~     used routinely during chemotherapy and need to be validated in the cancer field.~      These parameters include:~        -  An assay of reticulocyte hemoglobin content (rHC)~        -  An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are~          mainly located on red blood line cells receiving iron delivered by transferrin.~      In this study, we propose to make a prospective assessment of the iron status of cancer~     patients beginning chemotherapy. The aim is to determine the proportion of patients who~     might benefit from injectable iron treatment. All ID will be covered prospectively over a~     2-year period.~   "
83206|NCT01968291|"~     The purpose of this study was to determine whether use of teach-back discharge instructions~     improve patient satisfaction and patients' self-reported and objective comprehension of~     discharge instructions in the emergency department when compared to standard discharge~     instructions.~   "
85372|NCT01939964|"~     To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.~   "
83207|NCT01968278|"~     Oral immunotherapy (OIT) programs for milk, egg and peanut, desensitize patients to their~     respective allergens and thereby decrease their risk of morbidity and mortality. OIT~     programs, however, are not without adverse events, particularly in highly sensitive~     patients. Recently, it has been demonstrated that the administration of baked milk (BM)~     products to IgE-CMA patients that are non-reactive to BM, can promote tolerance to unheated~     milk (UM). The goal of our research is to determine whether BM can promote desensitization~     even in the highly sensitive patient, who reacts to baked milk as well. In a second step, we~     hypothesize BM-OIT will promote desensitization to unheated milk, as well.~      Importance: The change in the risk/benefit ratio of such a program will alter the~     therapeutic approach to an IgE-CMP allergic patient.~      Probable implications to Medicine: BM-OIT will allow highly sensitive patients to tolerate~     milk products, decreasing their risk of life-threatening reactions. Furthermore, analysis of~     the immune modulation parameters that change during the treatment program, should pave the~     way for defining mechanisms underlying tolerance in CMP allergy.~   "
83208|NCT01968265|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     ISIS-GCCRRx in combination with metformin versus placebo + metformin~   "
83209|NCT01968252|"~     The study is designed to validate the use of speckle-tracking echocardiography to measure~     tricuspid annular plane systolic excursion as a measurement of right ventricular function~     during transesophageal echocardiography.~   "
83210|NCT01968239|"~     The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of~     ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is~     guided by morphological macular changes detected by OCT compared to re-treatment according~     to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease~     of BCVA).~   "
83211|NCT01968226|"~     The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when~     used as a tracer during PET (positron emission tomography) imaging, to detect regions of~     unstable atherosclerotic plaque in the carotid artery of subjects being considered for~     carotid endarterectomy (CEA),and to confirm this ability through histological studies of~     samples of carotid artery plaques that will be collected during the planned carotid surgery.~   "
83212|NCT01968213|"~     Patients enrolled into this study will be stratified into 3 groups based on gene mutations~     identified in their tumor tissue. The purpose of this study is to evaluate patient response~     to maintenance treatment with rucaparib versus placebo. Response to treatment will be~     analyzed based on homologous recombination (HR) status of tumor samples.~   "
83213|NCT01968200|"~     Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could~     also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors~     (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to~     reduce the incidence of heart failure (HF).~      ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The~     main objective is to assess whether enalapril started concomitantly to AC-containing~     treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed~     to selected patients showing laboratory evidences of injury after chemotherapy, during~     follow-up visits in 268 patients.~   "
83214|NCT01968187|"~     The purpose of this study is to evaluate the safety and effectiveness of intranasal FE~     992097 in children and adults with Prader-Willi Syndrome.~   "
83215|NCT01968174|"~     Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated~     astigmatic corneal changes in children undergoing ptosis repair. Only several studies~     evaluated astigmatic changes following eyelid surgeries in elderly patients. The~     investigators aim is to estimate this change, implications on corneal astigmatism may have~     great effect to future cataract surgeries for this group of patients.~   "
83216|NCT01968161|"~     We propose a use of a unique facility, the databank at the CNDV, to examine the impact of~     switching subjects to asenapine in an open-label naturalistic setting. This offers the~     following advantages: i) providing data on a particularly important population, i.e.,~     subjects who are at the inception of treatment for a psychotic disorder and who are likely~     to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical~     setting, with a clinical team dedicated to provide innovative interventions; iii) its~     naturalistic design, that will allow to obtain data that will be applicable to real-life~     clinical settings; indeed, subjects who will be switched to asenapine within the current~     project are those we would switch to this drug in our daily practice.~   "
83217|NCT01968148|"~     The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response~     after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac~     arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased~     secretion of insulin and glucose-like peptide 1 (GLP-1).~      Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first~     sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the~     samples.~      Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.)~     survivors and non-survivors.~   "
83218|NCT01968135|"~     The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive~     implants who report a bleeding-spotting episode of at least seven days will stop bleeding~     within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared~     to women receiving 14 days of placebo.~   "
83219|NCT01968122|"~     The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in~     patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high~     complication rate in patients in stenting group. However the intravascular therapy is going~     on because of low complication rate in considerable Chinese studies coming from several high~     volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the~     SAMMPRIS study, it is imperative to performing an multiple prospective registry study of~     stenting for patients with ICAS in China.~   "
83220|NCT01968109|"~     To assess the safety and tolerability, characterize the dose-limiting toxicities, and~     identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in~     subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide~     preliminary information on the clinical benefits of the combination.~   "
83263|NCT01967550|"~     This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient~     suffering from knee osteoarthritis (OA).~   "
83221|NCT01968096|"~     Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations.~     In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human~     and animal studies, histochemical and physiological evidences showed that the paralyzed~     muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.~      Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using~     high load electrical stimulations showed a reverse change of muscular properties, such as~     hypertrophy and reversal of fiber type transformations but failed to show a reversal of~     spinal circuitry function. Previous studies found that fast continuous passive motion (CPM)~     altered the H reflex excitability in human. Animal studies found that passive cycling and~     passive stretching delayed atrophy and influenced the transition of type I and IIa MHC.~     Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse~     both spinal circuitry and muscular properties after SCI but it has not been confirmed in~     human study.~      The purpose of this project is to investigate the effect of mechanical stimulation by fast~     CPM on the reversing adaptation of human paralyzed muscle after SCI.~   "
83222|NCT01968083|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children. This study will evaluate the safety and immune response to an RSV vaccine in~     healthy RSV-naïve children.~   "
83223|NCT01968070|"~     The main purposes of this study are to evaluate the safety and how well the body handles~     single and multiple doses of increasing strength of study drug, LY3127760. This study~     includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from~     Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last~     approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days~     prior to enrollment.~   "
83224|NCT01968057|"~     The purpose of this study is to determine the effects of ciclosporin on the amount of~     baricitinib that is absorbed into the blood stream and the time it takes to remove~     baricitinib from the body. The study will also look at how well-tolerated and safe~     baricitinib is, when given alone and in combination with ciclosporin. Side effects will be~     documented. The study will last approximately 6 days from the first dose to the end of the~     study (not including screening or follow-up).~   "
83225|NCT01968044|"~     Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal~     impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor~     gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term~     peirod (52 weeks).~   "
83226|NCT01968031|"~     This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in~     patients with moderate to severe Parkinson's Disease. While on this study, participants will~     continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or~     Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be~     randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per~     day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate~     the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to~     as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile~     in this group.~   "
83227|NCT01968018|"~     The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety~     of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic~     cancer pain.~   "
83228|NCT01968005|"~     The purpose of this study is to evaluate efficacy, tolerability and safety of~     Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).~   "
83229|NCT01967992|"~     The study is a pilot, designed to provide data regarding the feasibility and acceptability~     of conducting such a study on a larger scale. The present study is a randomized controlled~     clinical trial comparing two programs to help people manage diabetes and lose weight, one~     using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and~     the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect~     lifestyle modifications. Intervention content will include information about nutrition~     (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC~     group, emotion regulation, positive affect, and mindful eating strategies.~   "
83230|NCT01967979|"~     This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts~     will evaluate the effects of multiple doses of itraconazole and fluoxetine on the~     pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects~     will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of~     14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4.~     In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after~     a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of~     RO5285119 on Day 6.~   "
83231|NCT01967966|"~     This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability,~     pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety~     in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed~     by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.~   "
83232|NCT01967953|"~     The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and~     recondition lungs from marginal donors has opened a new era in the field of lung~     transplantation.~   "
83233|NCT01967940|"~     Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which 10 participants will~     be enrolled to receive open-label tenofovir alafenamide (TAF) in addition to their current~     failing antiretroviral (ARV) regimen. This cohort will then be followed by a randomized,~     double-blind, cohort to compare the addition of TAF or placebo-to-match TAF in HIV-1~     positive adults who are failing their current ARV regimen. This randomized cohort will~     consist of approximately 90 participants.~      In Part 2, all participants who complete Part 1 of the study will discontinue their failing~     ARV regimen and TAF or placebo-to-match TAF for a 14-day washout period. Following the~     washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline~     in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide~     single-tablet regimen (E/C/F/TAF STR) plus atazanavir (ATV) once daily for 48 weeks.~     Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be~     discontinued from the study and will not be eligible to continue into Part 2 of the study.~     All participants who received placebo in Part 1 will be eligible to participate in Part 2~     regardless of their viral load change.~   "
83234|NCT01967927|"~     To estimate the mean and standard deviation (SD) of the post-treatment decreases in the~     interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in~     patients with locally advanced squamous-cell carcinoma of the head and neck.~      The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid~     pressure within the tumors will be measured by assessing the trend and statistical~     significance of the difference in values for each condition obtained prior to and just after~     GRID exposure in each subject enrolled in the study. We expect that there may be a trend for~     increases in tumor oxygenation and decreases in interstitial fluid pressure which would~     indicate that more accurately timed additional chemotherapy and radiation therapy would~     improve overall patient outcomes.~   "
83235|NCT01967914|"~     The hypothesis is that plethysmography variability index can predict the occurrence of~     hypotension after spinal anesthesia for cesarean delivery~   "
83236|NCT01967901|"~     Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the~     elderly population. Despite advances in pharmacological and management strategies, DKD~     remain associated with high morbidity and mortality. Patients living with such chronic~     disease, are expected, on daily basis to manage their self-care activities. Patients'~     non-adherence to the treatment is thought to be the major cause for the poor control and the~     occurrence of complications. Previous researchers have shown that multidisciplinary~     management of chronic disease can improve patients' self-care and outcomes. However, none of~     these programs was centered on self-care and targeted patients with DKD. A multidisciplinary~     self-care management program could improve the outcomes of patients with DKD, and delay the~     progression of the disease.~      The aim of the study is to investigate the effect of a multidisciplinary self-care~     management program on self-care behavior, quality of life, medication adherence, glycemic~     control and renal function, in adults with DKD.~      The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from~     the Vaud University Medical Center, nephrology department and will be enrolled in the~     program for 12 month. All variables will be measured at baseline, three, six, nine and 12~     month. We will measure the patients' self-care behavior, quality of life, adherence to the~     anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care~     Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and~     the Medication Events Monitoring System. We will assess the patients' glycemic control by~     measuring the glycated hemoglobin and the renal function by measuring the serum creatinine~     and the microalbumin creatinine ratio.~      The study will clearly show if a multidisciplinary self-care management program will improve~     the health outcomes of patients with DKD and will allow us to recommend the establishment of~     such a program.~   "
83237|NCT01967888|"~     The study will be a phase 2/3, multicenter, double-blind, parallel assignment study. It will~     involve 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation~     (IAT).~      The objective of this clinical trial is to assess whether reparixin leads to improved~     transplant outcome as measured by the proportion of insulin-independent patients following~     IAT. The safety of reparixin in the specific clinical setting will be also evaluated.~   "
83238|NCT01967875|"~     The purpose of this study is to determine whether ERCC1(excision repair~     cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients~     with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a~     biological predictor for the individual therapy of gastric cancer~   "
83239|NCT01967862|"~     This phase II trial studies how well fluorine F 18 sodium fluoride positron emission~     tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance~     imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New~     imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial~     MRI, may be more effective than standard CT and bone scan in finding metastatic prostate~     cancer.~   "
83240|NCT01967849|"~     The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate)~     tolerance in lean children with a family history of diabetes and in overweight/obese~     children with or without a family history of diabetes mellitus.~   "
83241|NCT01967836|"~     The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for~     central line that is left in place during ambulatory oncology clinical care.~   "
83242|NCT01967823|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     cancer that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying them, and then giving the cells back to~     the patient. In a previous study the NCI Surgery Branch used the anti-ESO-1 gene and a type~     of virus (retrovirus) to make these tumor fighting cells (anti-ESO-1 cells). About half of~     the patients who received this treatment experienced shrinking of their tumors. In this~     study, we are using a slightly different method of producing the anti-ESO-1 cells which we~     hope will be better in making the tumors shrink.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the ESO-1 molecule on their surface can cause tumors to~     shrink and to see if this treatment is safe.~      Eligibility:~      - Adults 18 years old and older with cancer that has the ESO-1 molecule on their tumors.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.~          {Leukapheresis is a common procedure which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-ESO-1 cells and aldesleukin. They will stay~          in the hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
83243|NCT01967810|"~     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells~     in patients with high-grade glioma. Another purpose of this study is to assess the efficacy,~     safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.~   "
83244|NCT01967797|"~     The main goal of this project is to develop, implement and evaluate the 5As Team~     intervention (5AsT)for healthcare practitioners to improve their weight management patient~     encounters and improve patient health outcomes. The 5As of Obesity Management suite of tools~     is a robust, evidence-based approach to weight management, however its implementation and~     uptake has been heterogeneous in primary care.~      This project was co-created by, and will be implemented with, our partners the Southside~     Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed~     the need to change provider practice to increase the number of weight management visits.~     Despite a robust didactic training session on weight management for all providers, which~     includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT~     intervention to address the implementation of the 5As of Obesity Management in clinical~     practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups~     of multidisciplinary professionals that provide service to a defined group of patients~     within the SSPCN.~      The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner,~     dietician, mental health worker) who work collaboratively. The intervention is a learning~     collaborative where these 12 different 5AsTs get together to work to address facilitators~     and barriers to weight management in their settings over a 6 month period. Half of the teams~     (N=12) will remain as controls and deliver usual care. They serve as a comparison group for~     the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider~     practice and the effectiveness of the intervention and implementation.~      To assess the impact of 5AsT on patients, we will recruit patients presenting to the central~     SSPCN programming, We will not intervene directly on patients; we will observe the impact of~     the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where~     possible for 18 months. Data collected includes demographics, weight (BMI), waist~     circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in~     the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic~     illness (PACIC), and observed adherence to routine clinical care for guideline recommended~     laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).~   "
83247|NCT01967758|"~     This is a study for patients with brain tumors called astrocytic tumors. The study will~     enroll patients who have received standard treatment. The study will test a vaccine called~     ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see~     if ADU-623 can be given safely to brain cancer patients and what is the better dose to give~     patients among the three doses that planned to be tested. This study will also evaluate the~     length of time before patients' cancer worsens and if ADU-623 helps patients to live longer.~     The study will also measure the body's immune system response to ADU-623.~   "
83248|NCT01967745|"~     Comparison of open and laparoscopic appendectomy~   "
83249|NCT01967732|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile~     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the~     PK profiles from a single use of a conventional cigarette (CC) and from a single use of~     nicotine nasal spray (NNS).~   "
83250|NCT01967719|"~     The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate~     and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2)~     compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal~     spray (NNS).~   "
83251|NCT01967706|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile~     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS)~     compared to the PK profiles from a single use of a menthol conventional cigarette (mCC) and~     from a single use of nicotine replacement therapy gum (NRT).~   "
83252|NCT01967693|"~     Retrospective analysis of data from patients with laryngeal contact granulomas in order to~     identify possible differences and/or similarities between the cases and in order to~     determine whether and which conclusions can be drawn on disease and therapy.~   "
83253|NCT01967680|"~     Background: Every year 30,000 Danish patients are admitted to Intensive Care Units (ICU),~     accounting for 2-3% of all patients in hospital and 30% of the yearly hospital expenditure.~     The mortality in the ICU is 12.7 % and the 30-day mortality is 21.2 % according to the~     national Danish Intensive Care Database. Through many years, the standard care has been to~     use continuous sedation of critically ill patients during me-chanical ventilation. However,~     recent research indicates that it is beneficial to reduce the sedation level in these~     patients. A randomised trial found that continuous sedation with a daily wake-up trial~     compared to continuous sedation reduced the time on me-chanical ventilation and the length~     of stay in the intensive care unit. Further, a ran-domised trial comparing continuous~     sedation with a daily wake-up trial to no sedation found that patients in the non-sedated~     group needed mechanical ventilation for a shorter time and had a shorter length of stay in~     the ICU and in the hospital. The trial also indicated a beneficial effect on mortality,~     however the trial was not a priori de-signed or powered with respect to mortality. No~     randomised trial has been published comparing sedation with no sedation, a priori powered to~     have all-cause mortality as primary outcome.~      Objective: To assess the benefits and harms of non-sedation versus sedation with a daily~     wake-up trial in critically ill patients in ICU.~      Design: The NONSEDA trial is an investigator-initiated, randomised, clinical,~     parallel-group, multinational, superiority trial designed to include 700 patients from at~     least six ICUs in Denmark, Norway and Sweden.~      Inclusion criteria: Mechanically ventilated patients with expected duration of me-chanical~     ventilation > 24 hours.~      Exclusion criteria: non-intubated patients, patients with severe head trauma, coma at~     admission or status epilepticus, patients treated with therapeutic hypothermia, patients~     with PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or place~     the patient in prone position.~      Experimental intervention: Non-sedation supplemented with pain management during mechanical~     ventilation.~      Control intervention: Sedation with a daily wake-up trial.~      The primary hypothesis is that non-sedation compared to sedation and a daily wake-up trial~     will reduce mortality.~      The secondary hypotheses are that non-sedation compared to sedation and a daily wake-up~     trial will:~        -  Reduce the incidence of a composite outcome of death, acute myocardial in-farction~          (AMI), stroke, pulmonary embolism and other thromboembolic events.~        -  Reduce the number of organ failures.~        -  Increase the days alive without mechanical ventilation.~        -  Increase the days alive outside the ICU.~        -  Increase the days alive outside the hospital.~      Outcomes: The primary outcome is all-cause mortality at 90 days. Secondary out-comes are~     time to death in the trial period, the frequency of the trombo-embolic com-plications, acute~     renal failure, days alive without mechanical ventilation, days alive outside the ICU and~     hospital. Explorative outcomes are mortality at 28 days, organ failure and coma-free,~     delirium-free days.~      Trial size: The investigators will include 700 participants (2 x 350) in order to detect or~     reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II~     error risk of 20% (power at 80%).~   "
83254|NCT01967667|"~     Low levels of antioxidant molecules such as glutathione have been found in people with a~     diagnosis of schizophrenia. However, oral glutathione is not well absorbed because the~     compound is mostly broken down in the gastrointestinal system. Liposomes are tiny droplets~     of oil particles that encapsulate and protect the glutathione. In this study we will~     evaluate a liposomal formulation of glutathione for tolerability and to examine if this~     formulation serves the function of increasing glutathione in the brain and body.~   "
83255|NCT01967654|"~     Vietnam has a smoking prevalence that is the second highest among South East Asian countries~     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest~     total number of adult smokers (over 16 million) in SEA. According to the World Health~     Organization (WHO), most reductions in mortality from tobacco use in the near future will be~     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.~     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is~     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of~     recommended care is suboptimal. The objective of this proposal is to fill the current~     research-to-practice gap by conducting a randomized controlled trial that compares the~     effectiveness and cost effectiveness of two practical and highly replicable strategies for~     implementing evidence-based guidelines for the treatment of tobacco use in public health~     clinics in Vietnam. The proposed implementation strategies draw on evidence-based~     approaches, and the WHO's recently released guidelines for implementing Article 14 of the~     Framework Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that~     was developed by the WHO in response to the globalization of the tobacco epidemic. Vietnam~     ratified the FCTC in 2004; however, they have not taken steps to implement Article 14 which~     specifies the need to integrate best practices for treating tobacco use and dependence into~     routine preventive care. The proposed implementation strategies also build on the growing~     literature that supports the effectiveness of integrating community health workers as~     members of the health care team to improve access to preventive services.~   "
83284|NCT01967264|"~     The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg~     compared to placebo.~   "
83285|NCT01967251|"~     The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil~     25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract~     symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of~     erectile dysfunction (ED).~   "
83286|NCT01967238|"~     In order to produce better more effective vaccines, it is important to understand the~     particulars of why individuals have an effective or ineffective immune response to~     vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made~     by healthy volunteers who receive different vaccines or who have a viral infection to~     understand the nature of an effective (or less effective) vaccine response. The results of~     this research could be used to develop adjuvants to increase/ improve vaccine response.~   "
83256|NCT01967641|"~     In this study, we will assess opioid self-administration in a laboratory setting in persons~     with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate~     pain will be admitted to hospital for 7 weeks and transitioned from their baseline~     prescription opioid to a standing daily dose of Suboxone (buprenorphine/naloxone~     combination). During this maintenance period, participants will have the opportunity in a~     laboratory setting to self-administer oxycodone; subjective responses as well as analgesic,~     physiological and performance effects will be measured. In the second phase of this study,~     the same patients who participated in the inpatient phase will be followed on an outpatient~     basis while maintained on Suboxone for 12 weeks. . The hypotheses of this study are that (1)~     higher progressive ratio break-point values for oxycodone, higher subjective ratings of~     euphoria, and less pain relief will predict early relapse to opioid abuse; (2) the abuse~     liability measures will be more strongly correlated with relapse than the pain measures; (3)~     subjective ratings of euphoria will increase and of pain will decrease in an oxycodone~     dose-dependent manner (i.e. euphoria will increase and pain will decrease as dose~     increases); and (4) experimentally induced pain will decrease in an oxycodone dose-dependent~     manner.~   "
83257|NCT01967628|"~     For most individuals, the lung has a remarkable ability to deal with exposure to a variety~     of inhaled bacteria. Some individuals, however, do have recurrent bacterial infections,~     usually in the form of acute or chronic bronchitis and, in some instances, pneumonia. The~     reasons for this variability in bacterial infections between otherwise healthy subjects,~     between types of lung disease, and within the same type of lung disease are poorly~     understood.~      Variability in susceptibility to bacterial infections is partially explained by differences~     in exposure to infectious agents, genetic susceptibility and innate (or early) immune~     responses. It is of interest that the incidence and severity of bacterial infections is~     greatest during the winter months. Other than viral infections, there are few variables that~     change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The~     hypothesis of this study is that levels of vitamin D are an important determinant of the~     innate defense of the lung against inhaled bacteria. The investigators further postulate~     that vitamin D has effects on the innate immune function of both alveolar macrophages and~     lung epithelial cells.~   "
83258|NCT01967615|"~     Prasugrel and ticagrelor were both associated with a significant reduction in the risk of~     MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The~     1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients~     receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of~     biologically active stent (DES or BVS) thrombosis is largely variable according to~     different lesion settings. We aim to verify the translation of the postulated different~     reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and~     ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating~     lesions.~   "
83259|NCT01967602|"~     The goal of this project is to find a marker expression that the investigators can use to~     trace symptom progression and develop a more efficient therapy to enhance ARDS patient~     survival rate and better post-ICU life quality.~   "
83260|NCT01967589|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a~     long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.~   "
83261|NCT01967576|"~     Background:~        -  Most treatments for malignant pheochromocytomas/paragangliomas (PHEO/PGL) are~          palliative and multidisciplinary. Chemotherapy using the combination of~          cyclophosphamide, vincristine, and dacarbazine has been successfully utilized in the~          management of rapidly progressive metastatic PHEO, with more than 50% complete or~          partial tumor response and more than 70% complete or partial biochemical response.~        -  VEGF expression and evidence of angiogenesis has been found in many PHEO/PGL, so it is~          plausible that interfering with VEGF signaling may result in anti-tumor activity in~          patients with PHEO/PGL.~        -  Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial~          growth factor (VEGF) receptors 1, 2, and 3. Pre-clinical data suggests that the~          anti-tumor activity of axitinib may result from its anti-angiogenic activity and that~          this is reversible when treatment is discontinued.~        -  Given the known clinical safety and efficacy of axitinib, an assessment of its activity~          in PHEO/PGL and its impact on the VEGF pathway in PHEO/PGL could provide valuable~          information.~      Objectives:~        -  Determine the response rate of metastatic PHEO/PGL to axitinib (AG-013736).~        -  Determine the progression-free survival of metastatic PHEO/PGL treated with axitinib~          (AG-013736).~        -  Explore the relationship of potential biological markers of axitinib activity with~          clinical outcomes.~        -  Perform pharmacogenomics analyses of drug metabolism and transport proteins through~          germline DNA examination.~      Eligibility:~        -  Adults with a confirmed pathologic diagnosis of PHEO/PGL by the Laboratory of~          Pathology, NCI~        -  Biochemical evidence of PHEO/PGL~        -  Imaging confirmation of metastatic, locally advanced or unresectable disease.~        -  Measurable disease at presentation~        -  ECOG performance status less than or equal to 2~        -  Patients must not have received prior therapy with a tyrosine kinase (TK) inhibitor~      Design:~        -  Phase II, open label, non-randomized trial~        -  Patients with metastatic pheochromocytoma/paraganglioma will receive axitinib (AG-~          013736 BID) in eight-week cycles~        -  Patients will be evaluated for response every eight weeks using RECIST criteria~        -  Tumor biopsies are not mandatory but every attempt will be made to obtain these from~          patients prior to starting axitinib and again 20 -30 days after treatment has begun.~        -  Approximately 12 to 37 patients will be needed to achieve the objectives of the trial~   "
83262|NCT01967563|"~     Background:~      - Popular weight loss plans often restrict carbohydrates or fat. Research shows that~     very-low-carbohydrate (ketogenic) diets lead to greater weight loss than low-fat diets.~     Researchers want to know if eating fewer carbohydrates changes the number of calories the~     body uses. They also want to know how a ketogenic diet affects hunger, hormones, and food~     preferences.~      Objectives:~      - To better understand how the body responds to different diets.~      Eligibility:~      - Men 18 to 50 years old who are healthy but overweight.~      Design:~        -  Participants will have 3 screening visits:~             1. Medical history, physical exam, blood test, and EKG. They will eat during the~               visit.~             2. For the week before the visit, participants will wear physical activity monitors~               daily. They will record everything they eat and sample the special diet. At the~               visit, they will receive an EKG and heart rate test while biking for 30 minutes.~             3. For the week before the visit, participants will wear the physical activity~               monitors. They will eat all their meals from the special diet that will be~               provided. At the visit, they will answer questions and bike for 60 minutes.~        -  After screening, for 1 week, participants will visit the clinic daily to receive that~          day s food. They will not eat or drink anything else except water.~        -  Then participants will stay at the clinic for 8 weeks. They cannot leave but can have~          visitors. Participants will wear physical activity monitors, bike daily, and follow~          different diets. Tests will be given daily, and may include weighing, X-rays, and blood~          and urine tests. They will spend several days in a monitored room to test oxygen and~          carbon dioxide.~   "
83264|NCT01967537|"~     Background:~      - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The~     only treatment for NETs is surgery, but most are found when they are too advanced for~     surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can~     be successful. They want to test if the study drug can be used along with imaging devices to~     detect NETs.~      Objectives:~      - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown~     primary and metastatic NETs in the gastrointestinal system and pancreas.~      Eligibility:~      - Adults over 10 years old with a suspected NET or family history of NET.~      Design:~        -  Participants will be screened with a medical history and physical exam, and have a~          blood test.~        -  Participants will undergo three scans. For all of these, a substance is injected into~          their body, they lie on a table, and a machine takes images.~      <TAB>- A standard CT scan of the chest, abdomen, and pelvis.~      <TAB>- An octreotide scintigraphy SPECT/CT.~      <TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the~     arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device~     takes images of the body. The entire session takes 90 to 120 minutes.~        -  Researchers will compare images from the three scans.~        -  Participants will have 1 follow-up visit each year for 5 years. At this visit, they~          will have a medical exam, blood taken, and a CT scan.~   "
83265|NCT01967524|"~     Myofascial pains are frequently found during the clinical examination of the patients~     presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology~     of this component of the pain characterized by triggerpoints found in the clinical~     examination, remains uncertain; its coverage contributes to the improvement of the global~     pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed~     injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these~     triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent~     fibers) but are they superior to the injections of local anesthetics of triggerpoints? The~     literature remains poor on the subject, justifying this randomized double-blind protocol~     comparing the efficacy of the botulinum toxin associated with a local anesthetic versus~     local anesthetic alone with a main criterion of evaluation in 2 months and a monthly~     follow-up as long as the patient remains improved and maximum in 6 months.~   "
83266|NCT01967511|"~     The purpose of this study is to establish the functional, molecular and genetic profile of~     fibroblasts from Fibromuscular Dysplasia (FMD) patients. This cellular profile will be~     compared against the profile of fibroblasts obtained from age- and gender-matched healthy~     control subjects. This cellular data will be supplemented by a detailed clinical history and~     evaluation, assessment of circulating protein and cytokine levels in FMD versus healthy~     control subjects, and DNA sequencing aiming to define the causative genetic mutation(s).~   "
83267|NCT01967498|"~     The purpose of our double-blind, placebo controlled study is to test the hypothesis that~     montelukast therapy might be associated with improved hearing in certain sub populations of~     children suffering from OME.~   "
83268|NCT01967485|"~     The purpose of this study is to determine if an individualized text messaging intervention~     for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in~     improving medication adherence and disease management.~   "
83269|NCT01967472|"~     The aim of this study is to address this gap in knowledge by measuring the level of patient~     adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to~     artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key~     factors that influence adherence. This will be addressed through a mixed methods study that~     will provide not only a measurement of adherence ACTs and malaria test results, but will~     also provide contextual information in order to better understand factors that affect~     adherence. Data will be collected through a series of interviews with health workers and~     parents/caregivers and through observations of patient-provider consultations.~      The first stage of the study begins with semi-structured interviews and observations of~     patients/caretakers' consultations with health workers and will look at how health workers~     diagnose and treat malaria. This will be followed by short exit interviews at the health~     facility with caregivers to assess patient satisfaction with services, as well as to test~     the consistency between the data obtained through structured observations and the exit~     interviews.~      Follow-up surveys at the homes of patients will be used to measure and compare the adherence~     of participants to two different ACTs (AQAS and AL) formulations and potential factors that~     affect adherence. Additionally, data will be collected using in-depth interviews to collect~     supplementary information in order to discover, in more detail, factors that may affect~     behavioral choices and/or attitudes with regard to adherence.~   "
83270|NCT01967459|"~     Administration of vitamin D will have a beneficial effect on postprandial leukocyte~     activation, oxidative stress and arterial stiffness in vitamin D deficient females. High~     doses of vitamin D may have a more pronounced effect than low doses.~   "
83271|NCT01967446|"~     The Investigators hypothesize that functional status scores in elderly women undergoing~     surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have~     returned to baseline at 12 weeks post-operatively.~      The Investigators hypothesize that greater co-morbidity, frailty and worse functional status~     before surgery are associated with slower functional recovery, prolonged length of stay in a~     hospital or nursing care institution and greater post-operative complications following~     surgery for pelvic organ prolapse.~   "
83272|NCT01967433|"~     To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to~     reduce the amount of standard sedatives used during colonoscopy in patients on chronic~     opioids.~   "
83273|NCT01967420|"~     This study aims to look at the effectiveness of a combination of cognitive remediation and~     social cognition training to improve cognition and functioning when compared to cognitive~     remediation alone. The target population will be those who are experiencing their first~     episode of psychosis.~   "
83274|NCT01967407|"~     The aim of the study is the evaluation of the ablation efficiency of the percutaneous~     irreversible electroporation (IRE) as primary ablation therapy of locally confined renal~     cell carcinoma (≤4cm, see inclusion and exclusion criteria).~      The ablation success will be proofed by magnet resonance imaging (MRI) and histologically~     after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors~     ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue~     can be preserved.~   "
83275|NCT01967394|"~     Approximately 400,000 live births occur to adolescents in the United States annually. Of the~     50% of adolescent mothers who experience depressive symptoms, less than 25% comply with~     referrals for depression evaluation and treatment due to lack of knowledge of depression~     symptoms (literacy), negative attitude towards mental health treatment, perception that~     individuals with depression are stigmatized (subjective norms), lack of understanding of~     health resources that are available to her and under her control (perceived control), and~     lack of time. Social media is a promising vehicle to reach and educate adolescent mothers~     since most adolescent mothers use social media for communication and to search for health~     information. Based upon the Theory of Planned Behavior, the investigators will target 11~     counties in Kentucky with a social media ad campaign that will result in adolescent mothers~     (n=140) from those counties enrolling in an internet based intervention related to~     postpartum depression. The previously tested intervention includes vignettes from other~     adolescent mothers, questions and answers, resources, and an option to enroll in text~     message service. Before the intervention, after the intervention, and two weeks later the~     adolescent mothers will complete established questionnaires to determine if the intervention~     improved attitude and subjective norms towards depression and depression treatment,~     perceived control and intention related to seeking depression treatment, and the number of~     adolescent mothers with symptoms of depression who receive depression treatment. Data will~     be compared to scores on the same instruments from adolescent mothers (n=140) from the~     control group (18 other counties in Kentucky) that have not been targeted with the social~     media ad campaign or participated in the intervention. Data from the adolescent mothers in~     the control group will be collected in partnership with community agencies. The overall~     purpose of this trial is to test a cost effective and feasible method for reducing the~     cognitive and emotional barriers to accessing depression treatment in adolescent mothers.~     The specific aims are to (1) measure the extent to which a social media ad campaign is~     effective as a recruitment strategy; (2) test the effectiveness of an internet based social~     marketing intervention on both intention to seek treatment and rates of depression~     treatment, and (3) examine the dose effect of the intervention.~   "
83276|NCT01967381|"~     The research proposed in this application will determine the initial efficacy, safety and~     tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a~     pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human~     laboratory study will be conducted. The proposed study is innovative and important because~     it will provide the impetus for the conduct of double blind, placebo-controlled trials to~     further demonstrate the efficacy of combined oxazepam and naltrexone for managing~     methamphetamine dependence.~   "
83277|NCT01967368|"~     Influenza is associated with significant morbidity and mortality. Institutionalized older~     adults (age>65) is the group associated with highest risk of complications. Influenza~     vaccines are the cornerstone of influenza prevention but one systematic review has found~     that there is no statistically significant difference against laboratory confirmed~     influenza. A major reason is immune senescence in older adults which result in weaker~     response towards vaccines when compared with young adults. Intradermal administration of~     vaccine has been suggested to improve immune response due to the abundance of~     immunostimulatory cells, such as dendritic cells in the dermis. Intradermal administration~     of influenza vaccine has been shown to have comparable or superior efficacy compared with~     intramuscular administration in the >60-year old population and the rates of adverse events~     post-vaccination were also comparable between them. The immunogenicity of intradermal~     administration has also been shown to be better in immunocompromised patients, including~     community dwelling older adults. In addition, intradermal vaccination has good acceptability~     and safety profile in different countries, so it has been licensed in Hong Kong and~     worldwide. However, there is little study regarding the efficacy of intradermal vaccination~     of influenza in institutionalized older adults, investigators therefore would like to~     perform a prospective, randomized study to compare the safety and immunogenicity between~     conventional full dose intramuscular immunization and full dose intradermal immunization of~     the trivalent influenza vaccine in institutionalized older adults.~      The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective~     as full-dose standard intramuscular injection in terms of seroconversion and seroprotection~     rate in institutionalized older adults. Finding of this study will be important in the~     vaccination of institutionalized older adults and immunocompromised patients as intradermal~     vaccine may induce a better immune response against influenza infection.~   "
83278|NCT01967355|"~     Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main~     cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not~     clear and the only therapy is preterm caesarean section. In severe preeclampsia an~     accumulation of triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is~     performed as lipid-removing therapy for treatment of preeclampsia in order to prolong~     pregnancy and provide the fetus more time for maturation. In this individual treatment~     patients with early preeclampsia (<= 32 weeks of gestation) will be offered a~     H.E.L.P.-apheresis to postpone caesarean section and therefore prolong pregnancy.~   "
83279|NCT01967342|"~     Chronic pain is a significant public health problem that affects over 116 million Americans,~     costs $600 billion annually, and is unequally borne by people in low-income brackets,~     especially ethnic minorities. Many individuals also have health literacy deficits~     (difficulty understanding their illness and difficulty navigating the health care system for~     treatment) putting them at a greater disadvantage. Treatment usually relies on expensive~     medical interventions that often have negative side-effects. Psychosocial treatments, like~     Pain Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually~     unavailable. Clinicians are poorly equipped to provide psychosocial treatments to patients~     with low health literacy. CBT has not been adapted and supported for use in individuals with~     low health literacy, and even educational materials are often poorly adapted for their~     needs.~      To address this problem, the PI completed a small trial showing benefits from health~     literacy-adapted pain education and CBT groups for chronic pain in a population with low~     income and low health literacy. Patients in both treatments reported lower pain by the end~     of treatment, and the effects were maintained at one year. Patients in the CBT group also~     reported less depression. The current study uses a larger sample, and directly compares~     these psychosocial treatments to medical treatment-as-usual to seek better evidence for or~     against their widespread use in community settings.~      Our research questions:~        1. In people with chronic pain and low income and/or low literacy, does participating in a~          health-literacy-adapted psychosocial treatment improve their pain and interference in~          daily activities due to pain by the end of treatment when compared with a group~          receiving typical medical care, and are these effects maintained 6 months later?~        2. Does participation in the CBT pain management group improve symptoms of depression~          better than a pain education group by the end of treatment, and are these effects~          maintained 6 months later?~      In partnership with a federally qualified health center, we will enroll 294 patients with~     chronic pain. Main outcomes will be patient-reported pain intensity, pain interference,~     depression, and perceived change. From an earlier trial, we expect that our participants~     will be ~75% female and ~70% African American, and will have low literacy and low income~     (~60% in the low 15% nationally on word reading, and 90% at or below the poverty threshold).~   "
83280|NCT01967329|"~     The CANHelp Working Group Treatment Trials are part of a comprehensive research program~     carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment~     component involves a series of community-specific trials designed with community input and~     varying on the specific treatment regimens and number of treatment arms among other study~     details.~   "
83281|NCT01967303|"~     Our study aimed to examine a possible association between Restless legs syndrome and~     cerebrovascular disease, by examining patients during hospitalization for acute stroke or~     transient ischemic attack, in a matched case-control design.~   "
83282|NCT01967290|"~     The objective of this study is to determine the impact of vibratory feedback on the quality~     and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in~     stroke patients. For that purpose the investigators use the SWORD system that combines 3D~     motion quantification wearable sensors and a vibratory module.~      The investigators hypothesize that vibratory stimuli during a motor rehabilitation task~     increase significantly the number of correct movements performed per unit of time.~      The design of the study is a cross-over randomized clinical trial. With the SWORD system in~     place each patient will perform the hand-to-mouth task twice (with vibratory feedback and~     without it), the order being random. The number of correct movements and other motor~     outcomes will be assessed continuously under both conditions.~   "
83283|NCT01967277|"~     This study will acquire data on hair growth of the head that is the result of treatment with~     a non-heat generating, laser product. This data will come from counting of terminal hairs~     before treatment begins and after treatment is completed. The treatment regime is every~     other day for 16 weeks.~   "
83289|NCT01967199|"~     The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting~     balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon~     expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of~     drug eluting stent restenosis.~   "
83290|NCT01967186|"~     Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results~     are however hampered by a relatively low number of islets surviving the transplantation into~     the liver, which currently is the site for transplantation. In the present study we compare~     a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in~     patients undergoing kidney transplantation from the same donor. In half of the intramuscular~     transplanted patients, the islets will be mixed with mesenchymal stemcells from the~     recipient to, possibly, improve the immunological aspects of the transplantation.~   "
83291|NCT01967173|"~     The purpose of this study is to find the best asthma treatment to add for Blacks who have~     asthma that is not well controlled on a low dose of inhaled steroid. This study will also~     try to find out if Black adults and children differ in how they respond to the medications~     used in this study.~   "
83292|NCT01967160|"~     A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and~     Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden,~     Denmark and Norway.~   "
83293|NCT01967147|"~     The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over~     Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating~     dry eye subjects with lipid deficiency.~   "
83294|NCT01967134|"~     This is a Phase I, open-label, dose-escalation study with three study groups. This study~     will be conducted in 25 HIV negative subjects, 17 of whom will have LTBI and 8 of whom will~     not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15~     ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with~     IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.~   "
83295|NCT01967121|"~     The purpose of this research study is to determine if the application of ice, control group,~     or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed~     muscle soreness from performing leg extension and flexion. Individuals will complete a~     health history questionnaire to determine if they qualify for this study. We will measure~     your leg girth with a measuring tape and take a pain measurement of your hamstrings by using~     a spring to press down on your leg. Individuals will then warm-up on a bike without~     resistance for 5 minutes followed by 10 regular leg extension and flexion exercises.~     Individuals will then perform 6 sets of 10 leg extension and flexion exercises on a biodex~     machine (similar to leg curl machines in the gym). Individuals will perform each set to the~     maximum effort of their capables. After each set of 10 individuals will have a 2 minute~     rest. We will ask you to rank your leg soreness on a scale from 1-10.~      Individuals will then be assigned to a modality of either ice, control group or compex.~     Individuals will perform the modality (ice, control, compex) we assign you to until you are~     no longer sore.~      Over the next five days individuals will return to measure their level of soreness, leg~     girth and pain pressure.~      This study will examine the following hypotheses:~      H1: There will be no difference in pressure pain threshold after using the Compex compared~     to other groups.~      H2: There will be no difference in perceived soreness after using the Compex compared to~     other groups.~      H3: There will be no difference in muscular strength after using the Compex compared to~     other groups.~      H4: There will be no difference in active range of motion after using the Compex compared to~     other groups.~   "
83296|NCT01967108|"~     The purpose of this study is to examine the efficacy of chest physiotheray treatment in~     preventing pulmonary complications and weaning faliure, in extubated critically ill~     patients.~   "
83297|NCT01967095|"~     The purpose of this study is to test the safety of different ways of taking erlotinib. The~     investigators want to find out what effects, good and/or bad, combination daily low dose and~     twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are~     also seeing whether different schedules of erlotinib are better at treating lung cancer that~     has spread to the central nervous system.~      CNS expansion phase:~      The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers~     and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly~     diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the~     expansion cohorts will undergo the same treatment plan as the patients in the dose expansion~     cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish~     the first 28 day (cycle 1) treatment period.~   "
83298|NCT01967082|"~     Objectives:~      The specific aim is to investigate the following objectives:~      Objective 1.1: Develop a prototype of the APPSPIRE (phone app of a smoking prevention~     interactive experience).~      This objective will not involve any data analysis. Objective 1.2: At post assessment,~     students enrolled in the study will qualitatively provide information about the usability~     and usefulness for the prevention and cessation sites.~      Objective 2.1: Investigate frequency of use of and exposure to APPSPIRE modules via an~     objective measure of general use.~      Objective 2.2: Investigate how feasible the program will be. Feasibility will be~     operationalized for this objective. Objective 2.3: Obtain a maintained use of APPSPIRE with~     high completeness and extent of completion.~      Objective 2.4: Evaluate change in stage of change from baseline to about 1 and 4-month~     follow-ups among participants.~   "
83299|NCT01967069|"~     The objectives of this study are to compare the efficacy and safety of DFD01 Spray to~     Vehicle Spray for topical treatment of moderate plaque psoriasis~   "
83300|NCT01967056|"~     Respiratory failure following extubation causes significant morbidity and increases~     mortality in teh surgical intensive care unit (SICU). However the causes of respiratory~     failure following extubation remain poorly understood. The investigators hypothesize that~     extubation failure can be predicted based on preoperative risk factors as well as ICU~     acquired morbidities including muscle weakness and renal failure.~   "
83301|NCT01967043|"~     This is a standard 3+3 Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181~     Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic~     or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.~   "
83302|NCT01967030|"~     The goal of the Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy~     (SWIFT) is to determine whether exposure to prolonged, intensive lactation, as compared to~     formula feeding, reduces the 2-year incidence of type 2 diabetes mellitus among 1,035 women~     with a recent GDM pregnancy. The study will also examine whether lactation intensity and~     duration have persistent favorable effects on blood glucose, insulin resistance, weight~     gain, change in waist circumference, and adiposity during the two-year postpartum period.~     SWIFT is a prospective, longitudinal observational study in women at high risk for~     conversion to diabetes and prediabetes during midlife.~   "
83303|NCT01967017|"~     Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive~     IUDs secondary to the pain associated with insertion. Nulliparous women may be especially~     susceptible to procedure-related pain from IUD insertion. This study will investigate the~     difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo,~     among women who have not had a vaginal delivery before. The investigators anticipate that~     among women who have not had a previous vaginal delivery, the pain associated with IUD~     insertion will be significantly decreased after administration of local anesthesia.~   "
83304|NCT01967004|"~     The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead~     to greater prosthesis function and control. Subjects are asked to perform specific tasks and~     actions using the traditional control method, as well as RFID control.~   "
83305|NCT01966991|"~     This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used~     as a primary screening test for Down syndrome as part of routine clinical care in the~     general pregnancy population. Plasma ccfDNA testing is currently recommended only for use as~     a secondary screen for 'high-risk' women (i.e., women whose risk factors for trisomy make~     them candidates for invasive testing such as chorionic villous sampling or amniocentesis).~     Because most women in this 'high-risk' category are carrying unaffected fetuses, many~     'unnecessary' procedures are completed in order to identify the few women whose fetuses have~     a chromosomal disorder. This creates expense, anxiety, and most importantly, loss of~     unaffected fetuses due to procedure related miscarriage. Plasma DNA testing is now being~     used to reduce significantly the number of women with unaffected fetuses undergoing invasive~     testing.~      Applying such testing as a 'first-line' screen has not been well-explored, despite calls~     from several clinical professional societies to do so. The investigators intent is to~     introduce, under carefully monitored conditions, ccfDNA testing through Rhode Island primary~     prenatal practices to the general pregnancy population. Education/orientation of prenatal~     care providers, their staffs, and their patients will be carefully orchestrated, and~     implementation issues identified and addressed. Telephone surveys of consented patients will~     elicit responses to their understanding of the test, their satisfaction with the process,~     and a comparison of their experience with serum screening in a prior pregnancy. Knowledge~     gained from this study will help validate new screening paradigms involving ccfDNA testing.~     The study is not designed to estimate Down syndrome detection rates with any confidence, but~     can provide information on uptake rates, failure rates, screen positive rates, and the~     decision-making of women with positive test results.~   "
83306|NCT01966978|"~     The aim of this clinical trial is to assess and compare the effect of insulin detemir in~     combination with liraglutide and metformin versus insulin detemir in combination with~     insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).~   "
83307|NCT01966965|"~     This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in~     the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the~     infestation, along with the people in your family life. All will be submitted to the dosing~     regimen recommended in the package insert. 100% of the sample shall be subjected to clinical~     evaluation through comb, pre and post treatment and monitored after thirty days for~     evaluation of safety and possible adverse effects that may arise related to any of the~     components of the formula.~      The efficacy study is active comparator, non-inferiority.~   "
83308|NCT01966952|"~     Renal sympathetic radioablation disrupts the nerves by high radiofrequency signal which~     creates localized heat, eliminates the signal and decrease blood pressure.~      The main purpose of this study is to evaluate blood pressure 12 months after radioablation,~     and to evaluate the short and long-term effects of the renal radioablation on the extent of~     changes in urine catecholamines level, vascular stiffness, and sympathetic nerve activity as~     linked with the changes in blood pressure. The study will also evaluate the effect~     radioablation has on the renal arteries as well as develop teaching sessions for family~     physicians and other specialists to educate them on this new treatment.~   "
83309|NCT01966939|"~     There are two purposes on this study:~      - to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ)~     movement, function and quality of life (QoL)~   "
83310|NCT01966926|"~     Scant data have been reported on the effects of weight self-monitoring during weight~     control. The purpose of this pilot project was to consider the questions: Is it possible to~     assign participants to engage in daily weight self-monitoring, and are there differential~     effects on mood of daily versus weekly weighing?~   "
83311|NCT01966913|"~     High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard~     salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).~      Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/-~     ifosfamide depends on the patient's performance status (PS) at inclusion and the prior~     sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin~     suggest a higher toxicity and a bad prognosis.~      However, predictive factors of response to high-dose chemotherapy do not include a~     chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound~     (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this~     chemotherapy combination induced a response in more than one third of the patients treated~     during disease progression in the TAXIF I study. The same strategy was tested in the TAXIF~     II study, which completed the inclusion of 45 patients and was closed in May 2008. Results~     of the TAXIF II study, are currently being analyzed; they support the hypothesis to~     prioritarily treat patients with a sensitive relapsed disease at the time of the high-dose~     administration.~      A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used~     on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed,~     the overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an~     independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy~     using an inductive chemotherapy followed, in case of response, by a double intensification~     therapy in combination with a VEGF treatment, could be an interesting approach in patients~     with poor prognosis germ cell tumors.~      The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE~     (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous~     hematopoietic stem cell for two intensive consecutive cycles (tandem intensification) in~     patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization~     chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.~   "
83323|NCT01966757|"~     Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common~     neurodegenerative disorder in children. Families often report the patient has a sleep~     disturbance. This is a questionnaire to be completed by the family to better understand the~     sleep pattern and sleep difficulties experienced by individuals who have been diagnosed with~     NCL.~   "
85373|NCT01939951|"~     This study aims to find out if AES ( Activation Energy Serum) , a blend of natural minerals~     , is effective and safe for the treatment of asthma if taken for 4 weeks . The efficacy will~     be scientifically tested by symptoms scores, questionnaires, breathing and blood tests.~   "
83312|NCT01966900|"~     The potential HIV vaccine has two components: a protein immunogen based on the coat protein~     of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The~     immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous~     formulation (GLA-AF).~      We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response~     stimulated by the vaccine) when it is given in two different dose regimens:~      Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2~     and 12.~      Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5~     micrograms of GLA-AF.~      We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the~     vaccine by monitoring the occurrence of adverse events in the participants. We will assess~     the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood~     and in genital mucosal secretion samples.~   "
83313|NCT01966887|"~     The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer~     on cardiac volumes and function using multimodality cardiac imaging.~   "
83314|NCT01966874|"~     The purpose of this study is to determine the efficacy and acceptability of a regimen of 200~     mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.~   "
83315|NCT01966861|"~     The present study aims to evaluate the impact of a weaning strategy based on identification~     of early signs of respiratory distress by lung ultrasound and the consequent implementation~     of a clinical optimization protocol as compared to usual care.~   "
83316|NCT01966848|"~     In the history of TKA several different types of prosthetic designs have been evolved in~     order to optimize knee function after total knee replacement. The most common difference~     between the prosthetic designs revolves around issues concerning the preservation of the~     cruciate ligaments. The most popular prostheses have been the posterior stabilized~     prosthesis (PS) in which both cruciate ligaments are resected and the posterior cruciate~     retaining prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these~     prosthetic designs have shown excellent clinical results in the literature.~      In the knee the role of the cruciate ligaments is to insure anterior/posterior stability,~     but studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms~     which control joint kinematics essential for accurate knee function. One could therefore~     imagine that a prosthetic design that preserves both cruciate ligaments would be superior to~     prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results~     and patient satisfaction.~      Only a few prosthetic designs, which preserve both cruciate ligaments, have been available~     to the market. However studies based on fluoroscopic assays and gait analysis has shown that~     this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee~     kinematics during activities of daily living after TKA. Studies, in which patients have~     received two different types of prosthesis in each knee, have also shown that bi-cruciate~     retaining TKA's is preferred, when compared to more constrained prosthetic designs.~      The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of~     the Vanguard TKA system, which has shown good clinical results in earlier studies. With the~     new Vanguard XP system both cruciate ligaments are preserved. In theory this should result~     in a more natural feeling of the knee because the stability and proprioceptive signals from~     both cruciate ligaments are preserved. In order to investigate the potential benefits of~     this new prosthetic design, the clinical and radiological results of knees receiving a~     Vanguard XP and Vanguard CR prostheses are compared.~      In this study we wish to investigate:~        1. If the use of the Vanguard XP prosthesis will influence the migration of the femur- and~          tibial components measured by Radiostereometric Analysis (RSA) when compared to the~          Vanguard CR prosthesis.~        2. If the use of the Vanguard XP prosthesis will result in increased participant knee~          function, satisfaction and quality of life when compared to the Vanguard CR prosthesis.~        3. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis,~          complication rates and revision rates when compared to the Vanguard CR prosthesis.~      This project is carried out as a randomized controlled double-blinded trial, in which the~     clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of~     either a Vanguard XP or Vanguard CR prosthesis is compared.~   "
83317|NCT01966835|"~     Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis~     and are associated with an increased risk of co-morbidity and all-cause mortality.Few~     studies have examined the possibilities of improving sleep in patients with rheumatoid~     arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training~     constitutes a potentially promising, non-pharmacological alternative to improve sleep.~      This study is a randomized controlled trial of 44 patients with rheumatoid arthritis.~      The aim is to investigate the effect of a moderate-to-high intensity aerobic interval~     training intervention on sleep quality and sleep disturbances in patients with rheumatoid~     arthritis.~      The primary hypothesis is that moderate-to high intensity aerobic exercise will improve~     objective measured sleep quality and sleep disturbances. The secondary hypothesis is that~     the intervention may improve fitness, subjective sleep quality and physical function as well~     as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.~   "
83318|NCT01966822|"~     Protease inhibitors (PI) have been associated with an acceleration of bone mineral density~     loss in HIV-infected individuals because of an enhanced osteoclast activity, although some~     controversial data have been also published. A first study suggest an increase of bone~     mineral density after switching from PI to raltegravir, the first generation integrase~     inhibitor, but there are no more data about this subject.~      Based on data that PI decrease bone mineral density by accelerating osteoclast cells and~     that the discontinuation of this drugs could improve bone mineralization, we propose a~     randomized prospective multicenter study to assess the impact of switching from PI to~     dolutegravir on bone mineral density in patients with low bone mineral density receiving a~     PI-containing regimen. At the same time, the study will help to assess the antiviral~     efficacy and safety of a PI-sparing regimen including dolutegravir as a simplification~     strategy in virologically suppressed patients.~   "
83319|NCT01966809|"~     This study will be aimed at investigating the effectiveness of a treatment for brain tumors~     called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug,~     called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is~     removed, red light from a laser will be shone into the tumor cavity through a~     light-diffusing sphere. This light will activate the photosensitizer, and possibly kill any~     tumor cells that may be left.~      We plan to measure how long the subject may go without a new tumor regrowth, and overall how~     long subjects survive. We will compare these results to typical results to see if we are~     seeing any improvements.~      Objective: To define the antitumor activity of Photofrin® and laser light activation within~     the confines of a Phase II study.~   "
83320|NCT01966796|"~     Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the~     management of health-care associated pneumonia (HCAP). Multiple risk factors have been~     proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of~     this study was to investigate the relationship between PSI and presence of MDR pathogens.~      Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December~     2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they~     fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.~   "
83321|NCT01966783|"~     The purpose of this study is to investigate the efficacy and safety of budesonide~     suppository for the treatment of acute ulcerative proctitis.~   "
83322|NCT01966770|"~     The aim of this fitting study is to evaluate the clinical performance of different hydrogel~     and silicone hydrogel contact lenses.~   "
83324|NCT01966744|"~     The purpose of the study is to develop, evaluate, and optimize an interactive website (the~     SMART portal). The SMART portal will use IBD-specific and general assessments and~     interventions to reduce the burden of common barriers to treatment adherence and enhance~     self-management skills. This study aims to build and revise the SMART portal according to~     feedback and testing from participants.~   "
83325|NCT01966731|"~     REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for~     children with confirmed SCA between 12 months and 10 years of age. The short-term goal is to~     obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for~     children with SCA in multiple distinct research settings in Africa. Based on that~     information, the longer-term goal is to make hydroxyurea more widely available for children~     with SCA in Africa, particularly those identified with SCA through expanded newborn~     screening programs.~   "
83326|NCT01966718|"~     It is hypothesized that repository corticotropin injection in combination with other~     biologic agents will be able to provide relief of both rheumatoid arthritis and acute~     exacerbations of rheumatoid arthritis for patients with disease that had inadequately~     responded to biologics previously.~   "
83327|NCT01966705|"~     Background~      Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the~     Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with~     considerable personal distress, functional disability and societal costs. Several studies~     have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health~     anxiety, both on anxiety itself and on secondary symptom measures (for example of~     depression). One published randomized controlled trial (RCT) has examined the feasibility of~     delivering CBT for severe health anxiety via the Internet as a form of guided self help.~     Participants had contact with a therapist via an e-mail-like system throughout the~     treatment. This approach yielded results superior to a waiting-list condition, thus~     potentially greatly increasing the availability of psychological treatment. However, more~     studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one).~     Additionally, little is known about the active ingredients and mechanisms of change involved~     in Internet-delivered CBT. For example, the significance of therapist support in relation to~     treatment outcomes remains to be determined. CBT-based self-help literature, so called~     bibliotherapy, has shown great promise in the treatment of several anxiety disorders,~     including panic disorder and social anxiety disorder. Two small pilot studies have indicated~     that bibliotherapy with no or minimal therapist contact could be suitable for treating~     health anxiety.~      Aim of the study~      The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33),~     Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without~     therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants~     with severe health anxiety.~      Participants in all treatment programs are expected to be significantly improved on measures~     of health anxiety, compared to participants allocated to the waiting-list condition.~   "
83328|NCT01966692|"~     When a drug company first develops a drug, the company has to show the Food and Drug~     Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is~     safe and effective, FDA approves the drug. The company can then sell the drug, which the~     company does using trade name. Only the drug company that developed the trade name drug~     is allowed to sell it. However, other drug companies can create their own version of the~     trade name drug, which usually happens after the patents for the trade name product run~     out. These drugs, often called generic drugs, potentially will be less expensive for the~     patient. In order to sell generic drugs, drug companies must show that their generic version~     is the same as the trade name drug in a number of ways. For example, they generally have~     to show that their product is intended to be used to treat the same diseases or conditions,~     that it has the same label, and that the product has the same active ingredient as the~     trade name drug. The generic company also has to show that generic product is~     bioequivalent to the trade name drug, meaning that the generic product gets to the part of~     the body where the drug works at the same rate that the trade name drug does. How to show~     how much drug gets to the part of the body where it works, and how fast, depends on the type~     of product the drug is. The primary aim of this research study is to aid the FDA in finding~     methods to ensure that the versions of generic drugs that are inhaled (for example, drugs~     used to treat asthma) are bioequivalent to the trade name drug. As a part of the research~     study, pharmacokinetic (PK) studies (studies measuring drug levels in the blood over time~     after inhalation) will be done using three different versions of fluticasone propionate (FP,~     a drug routinely used in asthmatic patients) administered using a dry powder inhaler (DPI,~     an inhalation device that delivers the drug as a dry powder). The results from this study~     will help FDA ensure that generic products are the same as the trade name drugs.~   "
83329|NCT01966679|"~     This study is a NIMH-funded multi-site clinical trial that includes UCLA as the coordinating~     site, with Emory University and Seattle Children's Hospital, as other recruiting sites, and~     the Nathan Kline Institute as the Data Management Center. The purpose of the study is to~     examine the effects of an investigational drug, AZD7325, as a potential treatment for~     high-functioning adults 18 -35 years old with Autism Spectrum Disorders (ASD). The primary~     study measures are effects on brain waves as measured by non-invasive brain wave recordings~     (electroencephalograms or EEGs), assessments of side effects, and measures of attention and~     learning.~      The study drug, AZD7325, is manufactured by Astra Zeneca, and was initially tested as a~     medication for anxiety disorders in over 488 subjects, but was not pursued for marketing due~     to too few benefits for anxiety. AZD7325 was found to have a very good safety profile and~     was tolerated by the majority of subjects. AZD7325 has some similar actions to currently~     marketed anxiety drugs in the benzodiazepine class, but lacks the sedative and negative~     effects on attention of the benzodiazepines. The study drug is designed to target the GABA~     neurotransmitter system which is believed to be abnormal in this population.~      There are 2 study phases. Phase 1 includes the recruitment of 24 healthy volunteers without~     mental disorder (6 per site) in order to establish normal EEG reference ranges. Controls~     will only be seen for one study visit which includes a clinical evaluation, physical exam,~     routine blood tests, and an EEG. Once control recruitment is complete, Phase 2 will begin.~      Phase 2 involves the recruitment of 40 adults (10 per site) 18 - 35 years old with a~     diagnosis of ASD, normal intelligence, and specific EEG patterns compared to control values.~     Screening for eligibility will be performed in one visit, which includes a clinical~     evaluation, tests of learning and intelligence, blood and urine tests, and an EEG. Those~     subjects who are found to be eligible will be enrolled in a 6-week medication study.~     Subjects with ASD who are enrolled will be randomly assigned to receive the study drug~     AZD7325 or placebo in matching capsules. Subjects will be seen weekly by study physicians~     and clincians for the 7 study visits, including 3 additional EEG recordings, and then for a~     final follow-up visit (9 total visits including screening lasting up to 11 weeks to~     complete). Study physicians can adjust the dose of study medication to reduce any side~     effects.~   "
83330|NCT01966666|"~     The purpose of the study is to determine the highest dose of TPI-287 that is safe and~     tolerable when administered as an intravenous infusion to participants with mild to moderate~     Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to~     gauge preliminary efficacy of TPI-287 on disease progression.~   "
83331|NCT01966653|"~     Developed before the establishment of a structured process for drug assessment,~     nitrofurantoin is now being prescribed frequently given the rise in multi-resistant~     gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical~     effectiveness. A randomized, controlled trial is needed to explore the clinical~     effectiveness and better define the side effect profiles of both nitrofurantoin and~     fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three~     international sites (200 each in Poland, Switzerland, and Israel) at increased risk for~     carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract~     infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a~     single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic~     response at days 14 and 28 post therapy completion. The study hypothesis holds that~     nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.~   "
83383|NCT01965964|"~     Translation of a validated questionnaire (SSQ) from english to german and validation of the~     german version. The SSQ consists of 17 well-structured questions for the assessment and~     quantification of patient reported difficulties in swallowing function. The tool is~     specifically designed to evaluate important aspects of swallowing function The questions~     cover the symptoms related to combinations of variables like the anatomic region, type of~     dysfunction, and the consistency of swallowed bolus.~   "
83332|NCT01966640|"~     Child food allergy represent 6 to 8% of child in industrialised country. Within this~     allergy, peanuts and egg allergy are one of the most common.~      Actually when there is a suspicion of food allergy, the OPT is the gold standard for the~     diagnosis. During the OPT we give increasing doses of the allergen to the patient and~     evaluate threshold causing a clinical reaction. This test is associated with a risk of~     strong allergic reaction and need a medical supervision.~      Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis~     of these allergy. Some publications demonstrate that these tests lack sensibility and~     specificity for child food allergy diagnosis.~      New tests have to be develop to diagnosis child food allergy without risks. The BAT is a~     cellular test able to evaluate the basophiles activation by specific allergen in vitro. This~     test allow us to evaluate more physiologically the sensitization of patients to an allergen.~     It is already used in drug allergy and it has been evaluated in infant milk allergy in an~     other clinical trial.~      In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food~     allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with~     food allergy and compare this results with the OPT at the same time. If the BAT results can~     predict the sensitivity of children to food allergen, it could limit the use of the OPT and~     reduce the risk of this test.~   "
83333|NCT01966627|"~     This is a study to investigate genetic predisposition to hepatic steatosis and the~     expression of gluconeogenic and lipogenic genes in livers of obese children and adolescents.~      Hypothesis 1: Common variants recently associated with variation in plasma TG levels~     identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect~     accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD).~     Gene variants act in additive or synergistic manner with progressive liver fat accumulation~     per additional risk allele.~      Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase.~     Furthermore, expression of lipogenic markers (SREBP1c) will increase.~   "
83334|NCT01966614|"~     The purpose of this study is to evaluate the safety and efficacy of a single treatment of~     PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.~   "
83335|NCT01966601|"~     To evaluate the overall safety and efficacy of TRV027 when administered in addition to~     standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients~     hospitalized with Acute Decompensated Heart Failure (ADHF).~   "
83336|NCT01966588|"~     The purpose of this study is to find genes that predict whether or not a person will develop~     side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation,~     or immune cell abnormalities. We will be collecting blood samples from participants who are~     taking second-generation antipsychotic medications. These blood samples will be stored over~     the long-term in a biobank, and will be used for later genetic testing and other cell-based~     studies.~   "
83337|NCT01966575|"~     Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not~     produce an egg each month, resulting in irregular periods. As a result, these women often~     need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional~     'clomiphene protocol' begins with a short course of progestin treatment to bring on a period~     (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence,~     however, has suggested that this progestin-induced shedding of the uterine lining (i.e.,~     withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to~     determine whether withdrawal bleeding has an impact on pregnancy rates for patients with~     PCOS undergoing a clomiphene cycle.~      It is hypothesized that patients who undergo ovulation induction with clomiphene citrate~     without prior endometrial shedding will have higher clinical pregnancy rates than those who~     begin with a progestin-induced withdrawal bleed.~   "
83338|NCT01966562|"~     The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this~     RCT is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the~     Multi-component training control group and control group (CG) for psychological well being,~     quality of life, proactive attitude and happiness in female aged subjects.~   "
83339|NCT01966549|"~     The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in~     participants with moderate to severe Chronic Obstructive Pulmonary Disease.~   "
83340|NCT01966536|"~     Women delay maternity and, as a consequence, available oocyte number and their quality~     decrease (9-18% of all IVF patients). Different treatment protocols have been developped~     nevertheless none of them optimal: the number of oocytes retrieved depends on the present~     ones. New generation of oocytes and follicles has been defended by some authors and bone~     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals~     able to activate dormant cells and to attract undifferentiated cells from other tissues~     (homing). This phenomenon has been described by our group in other human reproductive~     tissues like endometrium. The purpose of the study is to improve ovarian reserve in~     unfertile women with poor ovarian reserve by means of bone marrow protective capacity.~      CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing~     them to colonize ovarian niche.~      The study hypothesis is that CD133+ cells will improve ovarian reserve differentiating~     themselves into germ cells or, more likely, stimulating the niche to activate dormant~     follicles.~   "
83341|NCT01966523|"~     To conduct a pilot study of cluster randomized clinical trial of an practice intervention to~     improve the quality of care for suspected lower respiratory and and urinary tract infections~     among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched~     intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention~     compared to the control facilities there will be a trend towards a greater proportion of~     infections for which antimicrobials were initiated appropriately, and 2. in the intervention~     compared to the control facilities there will be a trend towards higher proxy satisfaction~     with decision-making, fewer hospital transfers, and lower antimicrobial exposure.~   "
83432|NCT01965327|"~     Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults~     for which there is presently no therapy. Recently, a study reported that interferon gamma~     (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with~     Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test~     whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of~     children with FRDA.~   "
83342|NCT01966510|"~     Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical~     or mismatch donor.~      Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion~     criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade~     non-hodgkin lymphoma in third line (who already received at least one autologous~     transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one~     autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in~     relapse less than 2 year after a fludarabine nbased regimen or in relapse after one~     autologous transplantation.~      Stem cell source: Two cord blood units containing both together more than 3x107 frozen~     nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the~     patients.~   "
83343|NCT01966497|"~     The main objective of this observational survey is to estimate the incidence, the typology,~     and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old.~     In this age group (aged more than 60y), three groups of patients with very different~     response rates and late outcome can be delineated with specific standard chemotherapy.~   "
83344|NCT01966484|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with~     neostigmine. The investigators compare the intubating conditions, incidence of postoperative~     myalgia (POM), patient satisfaction and the postoperative performance with respiration~     exercise device for these two muscle relaxants.~   "
83345|NCT01966471|"~     This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and~     safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta~     (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as~     adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following~     surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg~     and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three~     weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study~     treatment is up to 1 year. Enrollment is complete for this study and a total of 1846~     patients have been randomized.~   "
83346|NCT01966458|"~     This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the~     stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood~     pressure management. The study compares results of stroke incidence in a new cohort of~     subjects receiving optimal blood pressure management to a reference stroke incidence~     observed in the original IDE clinical trial (HW004) that did not specify optimal blood~     pressure management. In addition, a secondary endpoint will evaluate non-inferiority of~     stroke-free success on the originally implanted device to a control group (i.e. any~     FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare® HVAD~     or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD~     is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up~     period extending to 5 years post implant.~   "
83347|NCT01966445|"~     Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of~     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression~     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330,~     a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3.~     This study is a phase I, first time in human, open-label, dose escalation study. The purpose~     of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD)~     of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be~     conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and~     PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part~     2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s)~     selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the~     recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.~   "
83348|NCT01966432|"~     This add-on study of providing tobacco, alcohol and other drug screening, brief intervention~     and referral for treatment to a primary care high risk diabetic population leverages the~     existing research resources of a funded parent project Duke University CMS Innovation Award~     Southeastern Diabetes initiative (PI: Robert M. Califf, MD) to explore the feasibility of~     implementing Screening for substance use, Brief Intervention, and Referral to Treatment~     services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on~     diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's~     common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary~     care setting.~   "
83349|NCT01966419|"~     The purpose of this study is to determine whether ornithine phenylacetate can speed recovery~     from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic~     patients.~   "
83350|NCT01966406|"~     Nasogastric decompression was routinely used in most major intra-abdominal operations.~     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,~     and gastric distension). Wound and respiratory complications, and to reduce the incidence of~     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric~     decompression following elective abdominal surgery has been increasingly questioned over the~     last several years. Many clinical studies have suggested that this practice does not provide~     any benefit but could increase patient discomfort and respiratory complications.~     Furthermore, meta-analyses have concluded that routine nasogastric decompression is no~     longer warranted after elective abdominal surgery.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery. However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy .~      In spite more and more studies reported of no need of nasogastric tube after abdominal~     operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in~     studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include~     anticipated prolonged postoperative paralytic ileus caused by PD-related extensive~     destruction and potential risk of gastric stasis after PD. However, our pilot study of~     retrospective analysis of postoperative NG drainage amount in 100 patients recently having~     PD at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage~     amount in the first three days after operation. Theoretically, these patients will not need~     a nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective~     multicenter randomized trial to assess the need of a nasogastric tube after PD.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery.7-10 However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy .11-13 In spite more and more studies reported of no need of nasogastric tube~     after abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated~     causes of lack in studies to assess the need of a nasogastric tube after~     pancreaticoduodenectomy include anticipated prolonged postoperative paralytic ileus caused~     by PD-related extensive destruction and potential risk of gastric stasis after PD. However,~     our pilot study of retrospective analysis of postoperative NG drainage amount in 100~     patients recently having PD at our hospital showed more than 90 % of patients had less than~     200cc/day NG drainage amount in the first three days after operation. Theoretically, these~     patients will not need a nasogastric tube after pancreaticoduodenectomy. Therefore, we~     propose a prospective multicenter randomized trial to assess the need of a nasogastric tube~     after PD.~   "
83575|NCT01963442|"~     To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when~     compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of~     treatment in terms of clinical efficacy, in adults admitted to emergency services for a non~     severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin~     treatment (3GC or A/AC).~   "
83351|NCT01966393|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to~     regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1~     diabetes.~      The investigators hypothesized that 1) Controlling glucose levels using single- or~     dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours);~     2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in~     hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional~     pump therapy.~   "
83352|NCT01966380|"~     The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing~     performance properties is fulfilled and that the dressing is safe when used on wound types~     such as pressure ulcer, leg ulcer, and diabetic foot ulcer.~   "
83353|NCT01966367|"~     This study's goal is to determine the frequency and severity of acute graft versus host~     disease, to evaluate incidence of primary and secondary graft rejection, to assess event~     free survival and overall survival, to determine the time to neutrophil and platelet~     engraftment, to determine the time to immune reconstitution (including normalization of T, B~     and natural killer (NK) cell repertoire and Immunoglobulin G production), and to establish~     the incidence of infectious complications including bacterial, viral, fungal and atypical~     mycobacterial and other infections following CD34+ selection in children, adolescents and~     young adults receiving an allogeneic peripheral blood stem cell transplant from a family~     member or unrelated adult donor for a non-malignant disease.~   "
83354|NCT01966354|"~     The purpose of this study is to assess the efficacy and safety of three ultrasound~     assistance techniques for internal jugular venous cannulation, in terms of cannulation~     success and prevention of complications.~   "
83355|NCT01966341|"~     This program has been created to help patients with irritable bowel syndrome manage their~     symptoms and increase their functioning by using cognitive therapy skills and hypnosis.~   "
83356|NCT01966328|"~     This research is studying the effect that Resolvine injection will have on patients with~     vitreomacular adhesion.~   "
83357|NCT01966315|"~     The investigators are going to compare the sleep quality and quantity between~     dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill~     patients. And the investigators also compare the incidence of delirium between the two~     groups.~   "
83358|NCT01966302|"~     The purpose of this study is to see if Lung LLC's new experimental formulation of the~     medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can~     improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental~     drug is one that has not been approved by the U.S. Food and Drug Administration for use in~     the general public. This research study is for patients who have pulmonary arterial~     hypertension (PAH) and have just completed taking part in an earlier research study and~     received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium~     Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve~     their PAH.~      Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis~     (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH.~     The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The~     increased blood pressure in the lungs places a strain on the heart. The strain causes the~     heart to pump less blood into the lungs, causing shortness of breath and tiredness. The~     strain on the heart weakens the heart muscle making it less able to pump blood, a condition~     called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.~   "
83359|NCT01966289|"~     This study will be looking at whether CY/GVAX in combination with SGI-110 is effective~     (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and~     safe in patients with metastatic colon or rectum cancers.~   "
83360|NCT01966276|"~     The Synergy Trial will evaluate the safety and efficacy of a currently available medication~     (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS~     Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).~   "
83361|NCT01966263|"~     The objective of this study is to determine whether either a femoral nerve block (FNB) or~     local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal~     functional outcome after one year in patients receiving a total knee arthroplasty and~     following a fast track rehabilitation protocol.~   "
83362|NCT01966250|"~     The purpose of this study is to find out the effectiveness of integrative medicine model for~     pain relief and improvement of function and quality of life on the patients with pain after~     back surgery.~   "
83363|NCT01966237|"~     Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum~     creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for~     medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood.~     Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI~     through urinary biomarkers can predict altered drug levels is unknown.~      Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting~     in low blood pressure. Dose adjustments are not currently possible because of the late rise~     in SCr, and are based on clinical parameters that may lead to clinically relevant over or~     under-dosing. Thus, this study will address an important knowledge gap being the first to~     use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.~   "
83375|NCT01966068|"~     This study will enroll parents/guardians of children who receive treatment at one of the~     pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS)~     network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC)~     network.~      The study will use an evidence-based conceptual model to study determinants of~     implementation success, implementation outcomes, and health care outcomes resulting from~     implementing an already functional, electronic health record (EHR)-linked asthma portal,~     MyAsthma. The study will measure the portal's feasibility and determine the impact on~     providing asthma education and fostering patient engagement as well as the ability to~     collect patient-reported outcomes for children, evaluate medication use and side effects and~     track parents' preferences and goals.~   "
83364|NCT01966224|"~     This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The~     vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the~     vaccine is tolerated and how previous Phase IA research participants respond to the vaccine~     in a booster dose. CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not~     approved for use by the United States Food and Drug Administration (FDA) but is available in~     research studies like this one. The study is a Phase IB, prospective, three cohort, open~     label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with~     a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that~     participated in the previous Phase IA study (all the subjects participated in the previous~     study). The study will be conducted at 1 study center. Subjects are enrolled in the trial~     for a period of 80 days. The objectives of the statistical analyses are to establish the~     safety and to explore the immunogenicity of the LAMP-vax vaccine. All statistical analyses~     conducted on the data from this trial will be exploratory in nature.~      The primary objective of this Phase IB Study is to evaluate the safety and immunological~     responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly~     (IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM~     every 2 weeks in the previous Phase IA study.~   "
83365|NCT01966198|"~     Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic~     nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic~     validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse~     plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic~     nervous system state index (ANSSi).~   "
83366|NCT01966185|"~     The purpose of this study is to establish learning curves of mastoidectomy training in~     virtual surgical simulation training, to establish the long-term effect of repeat simulation~     training and to explore the transfer of skills, the roles of an integrated tutor function,~     self-directed learning and cognitive load.~   "
83367|NCT01966172|"~     To test if multimodal analgesia with different analgesic medication offer better pain~     relief, lesser side effects and is safe compared to conventionel opiod analgesia after~     cardiac surgery.~   "
83368|NCT01966159|"~     The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary~     Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length~     (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual~     estimate)~   "
83369|NCT01966146|"~     Aim of the study is the definition of criteria for a standardized assessment of heart~     function by 3D echocardiographic procedures. Standardized criteria will be defined to assess~     aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.~   "
83370|NCT01966133|"~     Investigators hypothesise that the use of transarterial chemoembolisation (TACE) after liver~     resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in~     the liver and thus improve survival of patients with high risk factors for residual tumor.~     The aim of this study is to compare the survival of patients with high risk factors for~     residual tumor undergoing liver resection plus post-operative TACE versus liver resection~     alone.~   "
83371|NCT01966120|"~     The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz)~     versus placebo in the field-directed treatment of mild to moderate actinic keratosis with~     photodynamic therapy (PDT) when using the BF-RhodoLED lamp.~   "
83372|NCT01966107|"~     The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse~     cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to~     assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study~     is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the~     effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients~     with moderate to very severe COPD, as defined by the Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) criteria.~   "
83373|NCT01966094|"~     It is estimated that over 1 million people in the United States have HIV infection. While~     HIV is treatable, there are still high rates of HIV-associated neurocognitive disorder~     (HAND). HAND is defined by low scores on memory testing. To meet the criteria for HAND, an~     HIV-infected individual has to have a low score on at least two different memory tests. It~     is estimated that 20-50% of people living with HIV have HAND. It is therefore still a common~     problem. While individuals with HAND typically improve on antiretroviral therapy for HIV,~     often this improvement is incomplete. Also, there are over 20 antiretroviral medications~     approved for HIV in the US. It is not clear if the specific choice of antiretroviral~     medication makes a difference in the improvement of HAND.~      The investigators have designed a small preliminary study in which subjects with and without~     HAND who have never been on treatment for HIV or have been off treatment for at least 6~     months are followed for the first 12 months after starting antiretroviral therapy.The~     investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will~     also be followed by their primary HIV medical provider. For the study, subjects will be~     followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks.~     Memory testing will be performed at baseline and each followup visit. Blood will also be~     taken at baseline and the three followup visits to measure changes in inflammation. A lumbar~     puncture will be performed at baseline and at 24 weeks to measure changes in inflammation~     and amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at~     the last study visit of 48 weeks~   "
83374|NCT01966081|"~     The aim of the study is to establish the existence of a relationship between the dietary~     intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans,~     using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the~     abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte~     phospholipids.~   "
83376|NCT01966055|"~     A study of the safety and pharmacokinetics of solithromycin capsules in adolescents~   "
83576|NCT01963429|"~     This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency~     ablation and hypofractionated proton beam radiation.~   "
83664|NCT01962272|"~     Background and aims: Cancer-related malnutrition is multifactorial and related to a bad~     prognosis. The aim of this study was to investigate the effect of intensive, individual~     dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-,~     gastric-, or esophageal cancer.~   "
83377|NCT01966042|"~     Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to~     chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the~     large number of patients with refractory angina due to coronary disease, despite of the use~     of multiple anti-angina medications, remain severely symptomatic with disabling angina.~      Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to~     be safe and associated with improved myocardial perfusion, reducing the symptoms of advanced~     coronary artery disease and increasing the functional capacity of patients whose therapeutic~     armamentarium available today has been exhausted.~      The study hypothesis was that the infusion of autologous mononuclear cells derived from the~     patient's bone marrow and delivered via intramyocardial injection in patients with~     refractory angina and normal or slightly depressed ventricular function, promote improvement~     in the anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.~   "
83378|NCT01966029|"~     There is currently no treatment for MPS IVA other than supportive care for the clinical~     manifestations of the disease. Enzyme replacement therapy (ERT) with BMN 110 to replace the~     deficient GALNS is a potential new treatment option for MPS IVA patients. BMN 110,~     containing recombinant human GALNS (rhGALNS) developed by BioMarin is expected to reduce the~     progressive, pathologic accumulation of KS, and improve signs and symptoms of the disease.~      The objective of this Phase 3B open label study (110-502) will be to evaluate the safety and~     tolerability of 2.0 mg/kg/week (qw) of BMN 110 in Australian patients with MPS IVA. In~     addition, a number of secondary and tertiary efficacy endpoints will also be investigated.~     The dose and regimen of BMN 110 have been selected on the basis of data from a Phase 1/2~     clinical study with BMN 110, nonclinical and in vitro studies with BMN 110, and clinical and~     nonclinical data from other enzyme replacement therapies.~      Extension Phase is included per amendment dated 10Mar 2014: To provide patients enrolled in~     the Initial Phase access to BMN 110 until commercial product becomes available in Australia~     and continue to assess long-term safety~   "
83379|NCT01966016|"~     Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left~     ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive~     heart failure and wide QRS in ECG. Positive response presents as improvement in quality of~     life, decrease in congestive hrat failure symptoms and signs, improvements in~     echocardiographic measurements and longer survival. About 30% of the patients do not respond~     to this treatment.~      A decrease in clinical response to CRT is expected in patients with those predictors:~     advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of~     mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and~     non-cardiac co-morbidities (lung disease, pulmonary hypertension, renal failure and~     diabetes).~      There are few solutions to increase the rate of clinical response to CRT, for example:~     endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated~     a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB~     with QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax)~     compared to a single pacing site over a postero-basal or lateral wall site).~      Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite~     cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to~     conventional CRT.~   "
83380|NCT01966003|"~     The purpose of this research study is to compare the effectiveness and safety of ABP 215~     against bevacizumab in men and women with advanced non-small cell lung cancer.~   "
83381|NCT01965990|"~     Body weight excess, from overweight to overt obesity, is associated with adverse health~     outcomes. In view of the time-trends of the obesity epidemic and the related cost burden,~     the search for effective strategies for weight reduction and long-term maintenance of weight~     loss (WL) is at the top of the agenda of public health systems.~      The current first-line strategy includes several treatment options and dietary interventions~     to be implemented together with an exercise program. Unfortunately, compliance with~     intervention in the long-term is difficult. It is not infrequent to observe people following~     one diet after another and experiencing multiple failures which, in turn, lead to higher~     body weight and adverse consequences on body composition and fat distribution. The higher~     the number of attempts, the more difficult the adherence to further interventions. In the~     presence of severe (body mass index >40 kg/m2) or complicated obesity, bariatric surgery~     could be proposed. This therapeutic option is effective, but is not devoid of complications~     and may be irreversible. Obesity-related complications, such as diabetes, hypertension or~     sleep apnoea are likely to occur more frequently with increasing body mass index (BMI) and~     rapid and considerable WL is mandatory to curtail such risks.~      In this scenario, alternative treatment options are warranted. About 40 years ago, after the~     introduction of protein-sparing modified fasting (PSMF) achieved through the use of oral~     high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies~     evaluated its effectiveness and safety. They showed that responsible and supervised very-low~     calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity.~      The purpose of the present study was to investigate the potential role of a 2-week course of~     enteral treatment with a very low-calorie protein-based formula in the management of severe~     obesity.~      The rationale of this treatment option rests on the following considerations: 1) VLCDs~     appear to be able to reduce cardiovascular risk rapidly and effectively; 2) VLCDs induce~     considerable short and long-term WL; 3) optimal compliance with the intervention, as active~     participation of the patient is not required; 4) continuous administration of the~     intervention formula by enteral route enables the the maintenance of the body amino acid~     pool.~      Before being proposed for clinical use, a new WL program should be scientifically evaluated.~     Accordingly, in the present study, attention was focused not only on efficacy in terms of~     improving the cardiometabolic risk profile, but also on the feasibility and safety of the~     procedure.~   "
83382|NCT01965977|"~     High-intermediate or high risk in IPI has a long-term chance of cure in the range about 50%~     in patients with DLBCL treated by R-CHOP. These high risk patients should be considered for~     additional new treatment to standard R-CHOP or investigational approaches in the context of~     clinical trials that are designed to ensure that potentially curative therapy.~      Bortezomib has shown activity in vitro against DLBCL-derived cell lines. Single-agent~     bortezomib or chemotherapy combined bortezomib are feasible in follicular, mantle cell,~     marginal zone lymphoma and DLBCL with manageable toxicities. Bortezomib enhances the~     activity of chemotherapy in non-GCB but not GCB DLBCL, and provide a rational therapeutic~     approach based on genetically distinct DLBCL subtypes.~      High CR/CRu rate with bortezomib with standard R-CHOP suggests it may be a good backbone for~     additional maintenance leading to durable response. However, there is no study of bortezomib~     as maintenance therapy after treated with R-CHOP in high risk patients with DLBCL. So we~     applied additional bortezomib as maintenance therapy in order to assess improving efficacy~     and survival rates in high risk patients with non-GCB DLBCL who had been confirmed CR after~     treated with R-CHOP.~   "
83702|NCT01961778|"~     The two treatment modalities under investigation are clinically equivalent (non-inferior) to~     each other for the endoscopic treatment of Barrett's esophagus with HGD and/or early~     esophageal adenocarcinoma.~   "
83384|NCT01965951|"~     Problems with attention are a common and debilitating consequence of brain injury. Studies~     show that poor attention is the number one predictor of poor cognitive functioning one year~     post-injury. This is due to the fact that attention is a necessary component of more complex~     cognitive functions such as learning & memory, multi-tasking and problem solving. In many~     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial~     neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery~     of the brain is plastic and remodeled throughout life by learning and experience, enabling~     the strengthening of cognitive skills or abilities. Research has shown that brief, daily~     computerized cognitive training that is sufficiently challenging, goal-directed and adaptive~     enables intact brain structures to restore balance in attention and compensate for~     disruptions in cognitive functioning. The study aims to understand how our computer program~     can affect cognition and attention in those with acquired brain injury.~   "
83385|NCT01965938|"~     We will conduct a randomized trial comparing the success rate and time to intubation using~     the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold~     standard of difficult airway devices. Specifically, we wish to compare the of intubation~     between the two devices in patients with potentially difficult airways as defined by an~     oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult~     intubation using direct laryngoscopy.~   "
83386|NCT01965925|"~     This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar~     disorder patients. Results will provide information on a promising treatment for~     simultaneously treating both sleep and cognitive problems in stable bipolar patients. These~     disabling symptoms persist despite stable mood and are strongly associated with functional~     disability, making them important treatment targets that have not yet been adequately~     addressed.~   "
83387|NCT01965912|"~     The study is a single-cohort, interventional, open-label trial to evaluate long-term~     neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU)~     treated with Kuvan® and Phenylalanine-restricted diet over a period of 7 years.~   "
83388|NCT01965899|"~     The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal~     LINQ insertable cardiac monitor and accompanying system in patients indicated for an~     insertable cardiac monitor~   "
83389|NCT01965886|"~     The most common surgical approach to perform a total knee replacement is called medial~     parapatellar approach. It's effective and can be applied virtually to all types of knee~     deformities. The Keblish approach is an alternative approach which uses the lateral side of~     the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a~     better option when facing a valgus deformity of the osteoarthritic knee but there is no~     convincing evidence on the literature supporting one or another approach. The objective of~     this study is to compare the medial vs lateral approach for total knee replacement on valgus~     knee.~   "
83390|NCT01965873|"~     The purpose of this prospective randomised clinical trial is to compare beneficial and~     harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid~     replacement principle of treatment in patients with moderate to severe acute pancreatitis~     (AP).~      The hypothesis:~        -  enteral nutrition is no significantly better compared with the nil-by-mouth principle~          regarding mortality, incidence of local and systemic complications, length of hospital~          stay, and intensity of the inflammatory response in patients with moderate to severe AP~        -  enteral nutrition has the same safety as nil-by-mouth principle in patients with~          moderate to severe AP~   "
83391|NCT01965860|"~     The main goal is to design a comprehensive endovascular simulation curriculum consisting of~     cognitive and psychomotor skills training for endovascular management of symptomatic~     vascular disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in~     the iliac, superficial femoral and popliteal arteries). The curriculum will consist of~     E-learning, video-based learning and simulation exercises on the Virtual Reality simulator~     on which an endovascular procedure will be simulated.~      Skills transferability to real life practice will be verified by means of a RCT. In this RCT~     the investigators will compare the cognitive knowledge and technical performance of~     curricular trained surgical trainees with conventionally trained trainees during treatment~     of patients under supervision. The hypothesis states that surgeons trained within the~     PROSPECT curriculum will show improved technical knowledge of endovascular treatment of~     atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will~     demonstrate increased technical proficiency in the angiosuite in comparison with surgeons~     who received only conventional training. Subjects will be surgical trainees (N=60). They~     will be randomized into a control group (N=30) and a PROSPECT group (N=30). Both groups will~     continue their traditional clinical education and the PROSPECT group will additionally be~     trained within this endovascular curriculum. The investigators hope that this study may~     ultimately lead to an improvement in the quality of patient care by standardizing~     competencies of endovascular operators in training and practice.~      Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training~     modalities will be executed. A successful training program is expected to lead to a~     shortening of the learning curve, reduction in number of errors during real life procedures~     and more efficient use of hybrid angio suites. The financial impact of potentially shorter~     duration of endovascular interventions will be studied and compared to time investment and~     additional costs associated with stepwise, supervised training using VR simulators.~   "
83392|NCT01965847|"~     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading~     cause of premature mortality worldwide. Ambulatory blood pressure (BP) monitoring (ABPM)~     allows for assessment of BP throughout the day and night. Of all the BP measurements,~     nighttime systolic BP appears to be the best predictor of cardiovascular disease and~     all-cause mortality. Importantly, elevated nighttime BP is a modifiable risk factor; evening~     dosing of antihypertensive medications lower nighttime BP and reduces proteinuria. In a~     large, randomized controlled trial, evening dosing of antihypertensive medications reduced~     the hazard rate for major cardiovascular events by 67%. Findings were similar in the~     subgroup of participants with chronic kidney disease (CKD). However, this single-center~     study was designed to evaluate cardiovascular outcomes, not progression of CKD. The~     long-term effect of nighttime dosing of antihypertensive medications on progression of CKD~     is unknown.~      To address this important gap in knowledge, the investigators plan to conduct a pragmatic,~     randomized controlled trial. 3600 participants at risk for progression of CKD who are taking~     ≥1 antihypertensive medication once daily will be randomized to morning versus evening~     dosing of at least one antihypertensive medication. The purpose of the current study is to~     obtain pilot data demonstrating the feasibility of the trial and the efficacy of the~     intervention.~   "
83523|NCT01964131|"~     The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent~     to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric~     pH>4.~      To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of~     percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.~      To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.~      To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20~     mg.~   "
83393|NCT01965834|"~     Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically,~     Ca2+ is required for the function of the endoplasmic reticulum in which proteins, including~     immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells~     secrete large concentrations of immunoglobulins continuously and as result depend on~     mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown~     in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting~     in inhibition of protein folding in the endoplasmic reticulum of MM cells that leads to the~     induction of a stress signal known as the unfolded protein response and subsequently~     apoptosis. The effective anti-myeloma concentrations for fenofibrate are attainable in the~     clinical setting as they are in the same range as the effective concentrations for~     anti-hyperlipidemic effect. The investigators propose to evaluate fenofibrate therapy in~     multiple myeloma patients.~   "
83394|NCT01965821|"~     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff~     underinflations and overinflations frequently occur in critically ill patients, resulting in~     increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is~     to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff~     pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal~     cuff pressure.~   "
83395|NCT01965808|"~     Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken~     at least 4 days apart. One dose will be given without food. One dose will be given with a~     high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug~     gets into the blood stream. Side effects will be documented. This study will last~     approximately 15 days not including screening. Screening is required within 30 days prior to~     the start of the study.~   "
83396|NCT01965795|"~     The purpose of this pilot study is to evaluate the potential effects of whole coffee fruit~     concentrate (WCFC, Neurofactor), a product that elevates circulating brain-derived~     neurotrophic factor (BDNF), on cognition and mood in healthy adults.~      The projected outcome of this study is that self-administration of Neurofactor for 28 days~     (or even 14 days) will be associated with an improvement in mood and scores on cognitive~     tests, and that the change will exceed that observed with administration of Nutrim~     (placebo).~      Volunteers will be recruited from the greater Los Angeles community. Participants will be~     middle-aged nonsmokers, in good health, and between the ages of 40-55 to enhance the chance~     of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is~     expected to be higher, may perform at a ceiling level, with less room for improvement by the~     product under study.~      Participants who call our lab will be told about the study in more detail, and will complete~     a 5 minute phone screener to determine preliminary eligibility. After the initial telephone~     screening, participants will visit Dr. London's laboratory at UCLA to provide written~     informed consent.~      The first study visit will be an in-person screening visit to determine full eligibility.~     The evaluation will include a psychiatric diagnostic interview, using the SCID, blood tests,~     urine samples (to test for drug use and pregnancy). Participants will also be interviewed~     about their prior and current drug use, including tobacco use. In addition, participants~     will be interviewed about the nature of their employment and physical exercise habits:~     endurance training has been shown to increase plasma BDNF in young men.~      Participants meeting the inclusion criteria will attend the Semel Institute for Neuroscience~     and Human Behavior at UCLA to take part in baseline measurements, and to be randomized to~     receive either WCFC or placebo. During the active treatment time (28 days), they will visit~     the UCLA Semel Institute on a weekly basis. At each of these weekly visits, questionnaires~     regarding compliance will be completed, and blood samples will be taken for assay of BDNF. A~     cognitive test battery and mood-rating scales will be completed at baseline and at 14 and 28~     days of treatment. At the midpoint assessment (14 days) and at completion of treatment (28~     days) blood will be drawn for assay of a blood chemistry panel (as at baseline) as well as~     for biomarkers in addition to BDNF.~   "
83397|NCT01965782|"~     This type of study is called a radiolabeled study. For this study, LY23023703 (study drug)~     has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally~     occurring radioactive form of the element carbon. This study will help understand how the~     drug appears in the blood, urine, and stool after it is administered to healthy men.~     Information about any side effects that may occur will also be collected. This study will~     last up to 15 days for each participant, not including screening. Screening is required~     within 28 days prior to the start of the study.~   "
83398|NCT01965769|"~     Omitting evaluation of gastric residual contents prior to feeding very premature infants~     will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks,~     as well as decrease the time required for parenteral nutrition.~   "
83399|NCT01965756|"~     Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive loss~     of memory and other cognitive functions. It is the most common cause of dementia in older~     adults, affecting approximately 18 million people worldwide, including almost 500,000 in the~     Philadelphia tri-state area. After age 65, the incidence of AD rises exponentially, doubling~     every five years. By age 85, almost half of us will have AD. In 2030, as many as 7.7 million~     Americans could have AD, and by 2050 this number could rise to 11-16 million people. The~     annual cost of AD in the United States is about $200 billion. AD-related medical~     complications are among the most common causes of death in the elderly population. Despite~     these alarming statistics, a cure for AD may not be essential since delaying the onset of~     AD by just 5 years could have a profound impact on this disorder by reducing the incidence~     and cost of AD by 50% between now and 2050.~      AD is difficult to recognize in its earliest stages, in which the principal complaint is~     typically an increase in episodes of forgetfulness. This stage is now commonly referred to~     as mild cognitive impairment (MCI). Neuroimaging and CSF biomarkers have demonstrated good~     accuracy in predicting which MCI patients later convert to AD and which tend to remain~     stable or revert to more normal cognition. The diagnosis of AD itself is made when increased~     loss of memory and other cognitive abilities (eg, language, praxis, and executive function)~     affect daily functioning. As the symptoms of dementia inevitably worsen, patients may become~     incapable of even basic activities such as feeding and dressing themselves. The disease~     course often spans more than a decade, creating a vast social and financial burden on~     society and extracting an immeasurable emotional toll on family members.~      Clinical and preclinical evidence is accumulating that brain insulin resistance may play a~     role in the pathogenesis and/or progression of Alzheimer's disease and that ameliorating~     insulin action in the brain may benefit cognition symptomatically and modify disease~     pathology.~   "
83400|NCT01965743|"~     This study has two goals: 1) to test an approach to helping women who use intrauterine~     contraception (IUC) spread the word about this type of long-lasting, highly effective birth~     control method among their friends and family and; 2) to test ways of getting in touch with~     these women's friends and family so that we can track whether this approach is effective at~     spreading birth control information through social groups.~   "
83401|NCT01965730|"~     This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and~     blood transfusion after cardiac surgery without increasing adverse events~   "
83402|NCT01965717|"~     Endovascular procedures already brought enormous revolution in the process of treatment of~     patient with abdominal aortic aneurysm (AAA). It is well defined that early mortality and~     morbidity is significantly reduced comparing to open repair. The persistent concern is long~     term durability of devices and their success of aneurysm exclusion in order to prevent~     rupture. At the moment the best armament to prevent rupture after endovascular exclusion is~     the watchful waiting and timely reintervention. The main complication that follows this~     procedure and causing catastrophic long term complications is endoleak. The ideal algorithm~     to follow up patients after aneurysm exclusion has not been found. In order to reveal~     endoleak ultrasound is used more than before, however frequent computerized tomography is~     wasting a lot of costs and exposing patients to irradiation and nephrotoxic contrast.~      Matrix metalloproteinase activity has been demonstrated in the process of aneurysm~     development. Imbalance between MMP and its inhibitors TIMP provokes collagenolytic and~     elastolytic activity that is inducing aneurysmatic degeneration of aortic wall. Due to the~     previously described connection between aneurysm and MMP activity, it was proved that serum~     level of MMP-9 is significantly higher in patients with abdominal aortic aneurysm (AAA).~     Also, higher levels of MMP-9 were discovered in patients with inadequate aneurysm exclusion~     after endovascular procedure suggesting that degradation of the aortic wall is still ongoing~     process, not being the case with successfully excluded aneurysm. There might be a potential~     role of MMP-9 serum level as a biomarker of present endoleak after endovascular aneurysm~     exclusion.~      All published trials have shown correlation between MMP 9 activity and presence of endoleak,~     however, no correlation was made between specific types of endoleak and necessity to~     reoperation (clinical significance). Additionally there were only four trials presented in~     the literature investigating low number of patients.~      Since there is possible value of MMP-9 serum level as biomarker of present endoleak, further~     studies are necessary. This why we are organizing multicentre trial, that will cover~     significant number of patients in order to define~        -  Value of MMP-9 as a biomarker of successful initial exclusion~        -  Value of MMP-9 level as predictor of aneurysm shrinkage~        -  Value of MMP-9 level in patients with increased aneurysm diameter and no visible~          endoleak~        -  Correlation of the MMP -9 serum level with different type of enoleak~        -  Value of MMP-9 as biomarker of successful treatment of endoelak~      Material and methods Patient with AAA greater then 55mm in diameter that are candidates for~     endovascular repair will be selected. Demographic, anatomical and data regarding the~     procedure will be gathered prospectively. Also serum levels of MMP-9 will be measured before~     procedure, during the first week before discharge, and after 1,6,12,18,24,36,48 months. On~     the same day of measuring MMP-9 level control MSCT and ultrasonography exam will be~     performed in order to collect data regarding the success of exclusion and presence of any~     endoleak with the accurate measurement of aneurysm diameter changes. Ultrasonography and~     MSCT exam will be performed by experienced physicians, also preoperative evaluation of~     anatomical data.~      In case of reintervention additional questionnaire will be filled regarding anatomical and~     procedure related data using pre and postoperative ultrasound and MSCT examination, while~     MMP-9 levels will be measured before procedure and after the procedure using the same~     protocol as for primary procedure.~      Statistical analysys Levels of MMP-9 in serum with presence of different types of endoleak~     will be correlated one week and 1,6,12,18,24,36 48 months after the procedure Anatomical~     data will be correlated with the decrease in MMP-9 level before and after procedure Levels~     of MMP-9 in serum after one week and one month will be correlated with further aneurysm~     shrinkage Level of MMP-9 in serum with type of endoleak will be correlated Level of MMP-9~     before and after reoperation will be compared Level of MMp-9 in serum of patients with~     disappearing endoleaks will be followed Level of MMP-9 in serum of patients with new~     endoleaks will be followed~   "
83524|NCT01964118|"~     The purpose of Intermittent Fasting study is to investigate whether intermittent fasting~     could decrease the chronic inflammation levels in overweight/obese people.~   "
85573|NCT01937312|"~     The purpose of this study is to demonstrate the additive effect of brinzolamide~     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or~     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.~   "
83403|NCT01965704|"~     The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal~     abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug~     ondansetron in the mothers prior to delivery and their babies after delivery.~      The study is a randomized, double-blind, placebo-controlled study with one half the~     mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to~     receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of~     study medication prior to delivery; the neonates, after their birth, will receive the same~     study medication the mother received every 24 hours for up to 5 days.~      The Investigators will follow up with the mother-baby pairs for 10 days after study drug has~     stopped and one last follow up, about 30 days after stopping study drug, to learn if the~     baby had any symptoms of NAS in that time period.~   "
83404|NCT01965691|"~     Phenylketonuria (PKU) is an inherited inborn error of an amino acid phenylalanine (PHE)~     metabolism affecting 1:15,000 births. It is caused by a decreased activity of an enzyme in~     the liver called phenylalanine hydroxylase (PAH) which is important to convert PHE into~     tyrosine, another amino acid. Consequently, PHE accumulates in the blood leading to mental~     and developmental delays. Nutritional management is the primary choice of treatment that~     includes providing sufficient protein in the diet and at the same time restricting PHE.~     However the amount of protein to be given is unknown. A new technique called Indicator Amino~     Acid Oxidation (IAAO) will be used to determine the protein requirements in children with~     PKU (5-18y). The study will help treat and manage these children with sufficient protein to~     ensure proper growth and development. Current dietary recommendations range from 35-65 g/day~     and is based on factorial calculations.~      The investigators hypothesize that the protein requirement in children with PKU will be~     higher than the current mathematically calculated recommended intake of 35-65 g/day for the~     5-18y children.~   "
83405|NCT01965678|"~     Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life~     in a large sample of naive patients undergoing osteopathic manipulative treatment.~   "
83406|NCT01965665|"~     The purpose of this study is to prospectively evaluate the effect of Active Leptospermum~     honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and~     also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared~     to published reports of routine standard pin site care.~   "
83407|NCT01965652|"~     The purpose of this study is to evaluate the long-term safety of naldemedine for the~     treatment of constipation due to opioid therapy.~   "
83408|NCT01965639|"~     The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment~     existing standard of care in an effort to (1) improve population level diabetes management,~     health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2~     Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and~     quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare~     costs associated with Type 2 Diabetes Mellitus.~   "
83409|NCT01965626|"~     Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of~     oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of~     the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins~     on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent~     platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong~     University and other 5 well-known hospitals in China. In order to report the efficacy and~     safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of~     immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose~     dexamethasone therapy.~   "
83410|NCT01965613|"~     The purpose of this study is to determine if treatment with Xionix will improve wound~     healing for patients with pyoderma gangrenosum.~   "
83411|NCT01965600|"~     An endotoxin challenge will be administered to healthy subjects to induce production of~     inflammatory markers. An investigational drug or placebo will be administered prior to the~     endotoxin challenge to assess the effect of the investigational drug on the markers of~     inflammation. Safety and tolerability will also be assessed.~   "
83412|NCT01965587|"~     Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure~     alone in the treatment of menorrhagia~   "
83413|NCT01965574|"~     Preload dependence assessment is difficult during prone position, and to date, no~     hemodynamic parameters have been validated to rationalize fluid loading in that position.~     This study aims to validate several hemodynamic parameters, using continuous cardiac output~     by pulse contour analysis and transpulmonary thermodilution.~   "
83414|NCT01965561|"~     Normal human adult volunteers wereused to investigate the performance of medical devices~     intended to stop junctional bleeding on the battlefield.~   "
83415|NCT01965548|"~     In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most~     frequent source of bleeding in the abdomen.~      Historically, splenectomy was the treatment of choice for splenic bleeding. For~     exsanguinating patients, open splenectomy is still the proper choice of treatment if the~     spleen is a significant source of bleeding. However, for hemodynamic stable patients with~     splenic injury, non-operative management (NOM) is an alternative, assuming they have no~     other indication for surgery (peritonitis).~      Non-operative management includes observation and/or splenic artery embolisation (SAE), but~     the indications for observation and SAE varies between trauma centers. The greatest~     advantage of NOM is the preservation of splenic function.~      In the investigators hospital splenic artery embolisation was introduced in 2007. The~     investigators want to describe the treatment of splenic injuries in their hospital, to see~     if the number of splenectomies has been recduced after 2007, and to see if SAE has also been~     used in transferred trauma patients.~   "
83433|NCT01965314|"~     Investigators hypothesize that virtual reality based training offers an additional learning~     benefit over standard training (using cadaveric dissection and human volunteers) in~     preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial~     Plexus Blockade (USgABPB) in the clinical setting.~      Investigators hope that this body of work will aid the development of a visuo-haptic~     simulator used to improved training of doctors in performing USgABPB. Ultimately any patient~     having this procedure carried out in the future should benefit. In particular it will avoid~     the need for novice trainees to practice new techniques on patients.~   "
83434|NCT01965301|"~     Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)~   "
83416|NCT01965535|"~     This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)~     fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety~     and tolerability of each regimen as assessed by review of the accumulated safety data.~     Approximately 150 participants with genotype 1 HCV infection, who have previously received~     treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants~     will be randomized to 1 of 2 groups.~      Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks~      Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for~     12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks~      Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b;~     mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy~     treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or~     achieved HCV RNA < LLOQ).~   "
83417|NCT01965522|"~     Investigators plan to carry out a study to investigate two different pills, Vitamin D and~     melatonin, and whether they can reduce the spread of cancer cells in the tumors of women~     with breast cancer. These pills are inexpensive and have very few side effects. A large~     number of studies using cell cultures and animals have shown that both vitamin D and~     melatonin can help destroy breast cancer cells. However thoughtful and well-designed studies~     are necessary on humans to see if they can decrease the spread of breast cancer, and~     possibly even prevent breast cancer. The proposed study aims to understand the anti-cancer~     activity of vitamin D and melatonin. This knowledge will assist in creating efficient cancer~     prevention strategies for Canadians. This study will include women with breast cancer who~     are being planned for surgery, and will assess whether treatment with vitamin D (dose of~     2000 IU per day) in a group of 36 women, or melatonin (dose of 20mg per day) in another~     group of 36 women, or both pills together in yet another group of 36 women, reduces the~     spread of cancer cells when compared to a fourth group of 36 women who are treated with~     sugar pills. To do this we will measure a substance in the blood called Ki67, which provides~     information about the spread of cancer. Investigators will compare the Ki67 levels in the 4~     groups, and all women will receive identical appearing pills so they will not know which~     treatment they received.~   "
83418|NCT01965509|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate the effective therapeutic concentration range of PEX168, also~     decided to observe safety and PK/PD correlation by long-term continuous administration.~   "
83419|NCT01965496|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate whether the titration mode of administration could reduce the~     incidence of adverse reactions of PEX168, also decided to observe long-term continuous~     administration of PK/PD correlation.~   "
83420|NCT01965483|"~     The implementation of a weekly hypofractionated radiation could be an advantageous~     alternative. The convenience of less treatment days could cause a greater adherence,~     decrease of costs and increase the offer of radiotherapy to major number of patients in~     underserved areas.~      The purpose of this study is to determine in women with diagnosis of initial breast cancer~     undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a~     week regimen, with 5 fractions in total. The study will analyze the acute toxicity of~     radiation, the patient's self referred quality of life, the cosmetic breast appearance, as~     well the oncological safety. It will also be analyzed the viability of this more contracted~     regimen in our community setting, regarding the patient's adherence to the treatment.~   "
83421|NCT01965470|"~     The BCPP study is designed to test the hypothesis that implementing an enhanced combination~     prevention package which includes provision of ART to all participants, regardless of CD4~     count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing~     population-level, cumulative HIV incidence in a defined geographic area over a period of 3~     years and will be cost-effective.~   "
83422|NCT01965457|"~     The term adenoids describes lymphoid tissue on the superior and posterior walls of the~     nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged,~     adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice,~     and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries~     potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease.~     Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through~     Eustachian tube dysfunction or chronic adenoidal infection.~      Methods for identification of adenoid hypertrophy include the clinical history, examination,~     imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization~     of the nasal cavity with dynamic evaluation of any nasal airway obstruction.~      Objectives :~      The aim of this study is to prospectively examine invasive and non-invasive office~     procedures to assess adenoids hypertrophy, including clinical history, x-ray imaging, and~     nasal endoscopy.~      Methods :~      Prospective, observational study in pediatric patients aged 2-18 that will be referred to~     the otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed~     consent.~        1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will~          be evaluated at the clinic, as described by Paradise grading system.~        2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the~          patients had them at the time of referral. Adenoidal obstruction will be assessed by~          Fujioka's Adenoid-Nasopharynx ratio.~        3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office~          procedure using a 2.4mm Storz nasal flexible endoscope following an application of~          Lidocaine gel locally into the nostril and on the endoscope distal end. Adenoidal~          obstruction will be assessed by Parikh grading system.~   "
83423|NCT01965444|"~     The objective of this study is to establish required data for SEM Scanner analysis of the~     readings given by the SEM Scanner in the target patient population.. In order to better~     understand the data this non-invasive scanner provides a collection of data/readings is~     required to be collected in a certain population. This will help with clinical~     interpretation of the numbers and readings this device will provide.~   "
83424|NCT01965431|"~     The objective of this study is to evaluate the effect of multiple doses of BI 207127~     combined with faldaprevir on cardiac safety parameters in healthy subjects~   "
83435|NCT01965288|"~     The aim of this study is to compare the clinical performance of the Biofinity Toric~     (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of~     daily wear.~   "
83436|NCT01965275|"~     the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile~     Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of~     standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）~   "
83437|NCT01965262|"~     This purpose of this study is to compare the clinical performance and subjective acceptance~     of two different daily disposable limbal ring lenses.~   "
83425|NCT01965418|"~     This research puts liver biopsy as the enrollment screening criteria and the primary~     efficacy assessment indicators. Patients at different developmental stages of hepatitis B~     related liver fibrosis are respectively diagnosed and treated by Traditional Chinese~     medicine to determine optional diagnosis and treatment plan of traditional Chinese medicine~     to screen the advantage-treated population and to establish a treatment program, which can~     save national medical resources, for clinical application of Traditional Chinese medicine~     Diagnosis and Treatment blocking and reversing hepatitis B-related liver fibrosis. The~     research can help to build automation pathological analysis and diagnosis systems and~     non-invasive clinical assessment criteria and models of liver fibrosis which can be applied~     in clinical. It can also help to realize electronic patient data collection and management,~     to establish patients management centre and follow-up database. Then it will help to improve~     clinical efficacy of being blocked and reversed chronic hepatitis B related liver fibrosis~     by Chinese medicine Diagnosis and Treatment program, to reduce the incidence of liver~     cirrhosis and hepatitis B-related mortality, to prolong patients' survival and improve~     patients' quality of life, to make clinical efficacy, which is about Traditional Chinese~     Medicine blocking and revering chronic hepatitis B-related liver fibrosis, increase by 15%~     or more .~   "
83426|NCT01965405|"~     In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care~     model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the~     efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent~     PLWHA that incorporate the current standard of care and prize-based contingency management.~     Intervention will be administered in a community-based HIV integrated care clinic in~     downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in~     Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help~     participants stop smoking. For phase 2, participants will be assigned to different study~     arms depending on whether they are Responders (reduced their smoking) or Non-responders~     (continued to smoke).~        1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will~          result in greater reduction in smoking than standard of care alone.~        2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management~          will be more likely to reduce their smoking throughout treatment and to abstain from~          smoking at all follow-up points.~        3. Phase 2b: We hypothesize that responders who are assigned to monitoring and~          low-magnitude prize contingency management will be more likely to maintain their~          reduced or abstinent smoking status at all follow-up time-points.~   "
83427|NCT01965392|"~     The aim was to assess whether nursing interventions based on Health Educational Programs for~     primary informal caregivers of dependent patients may improve their quality of life,~     decreasing emotional burden and increasing caregiving knowledge, in order to better meet~     patients' basic needs.~   "
83428|NCT01965379|"~     Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater~     risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and~     bone disease .~      The serum phosphorus level can be controlled by a combination of factors, such as: reduction~     of ingestion, reduction of intestinal absorption with chelating agents and increase in~     elimination by dialysis.~      The purpose of this study is to evaluate the effect of dietary intervention consisting of~     the restriction of industrialized foods with phosphorus additives in chronic kidney disease~     patients treated with hemodialysis.~   "
83429|NCT01965366|"~     Evidence from preliminary studies suggests that people with PTSD have heightened fear~     responses and that cortisol suppression reduces this heightened fear. Research has shown the~     drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians~     with PTSD. This current research proposal represents a blinded, randomized,~     placebo-controlled efficacy study with the goal of determining whether a drug that~     suppresses the stress hormone cortisol will increase the efficacy of exposure therapy.~     Specifically, it is proposed that a dose of DEX, given the night before (approximately 10~     hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions,~     will significantly enhance the rate of response and possibly the efficacy of treatment.~     Participants will be treated until they have experienced at least a 70% reduction in PTSD~     symptoms from baseline or up to 12 sessions or until they and their therapist agree~     treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions.~     Comprehensive multi-modal outcomes will be assessed by independent assessors blind to~     subject condition on interviews, self-report measures, and psychophysiological measures.~     Participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12~     months to assess long term effects.~   "
83430|NCT01965353|"~     This research study is evaluating an investigational drug called panobinostat (LBH589) in~     combination with the standard agents lenalidomide, bortezomib, and dexamethasone as a~     possible treatment for multiple myeloma.~   "
83431|NCT01965340|"~     Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and~     respiratory failure that used to be the major cause of mortality have progressively been~     replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs~     several weeks, or even months after injury as a consequence of sepsis usually caused by~     multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with~     topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn~     trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR~     bacteria.~      Correct prescription of anti-infective agents could be one way to curb the steadily~     increasing development of multidrug resistance. Administration of antibiotic to burn patient~     is complex: they frequently suffer from kidney dysfunction, they usually experience~     tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular~     compartments, they often are hypo-albumin and protein-emic, and finally they present with a~     profoundly modified metabolism. All those aspects make this particular population of~     patients at high risk of both under or over prescription.~      Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic~     Drug Monitoring, has been introduced to clinical practice for several decades primarily to~     avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the~     increasing availability of detection techniques, the number of drugs that can be measured in~     the plasma of patients has grown tremendously over the last decade. As a consequence, it is~     currently possible to monitor drug concentrations not only to prevent toxicity, but also to~     improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic~     prescription in different populations of hospitalized patients, including critically ill~     patients, with a direct impact on outcome.~      Such studies amongst burn patients are however lacking, although this particular population~     is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM~     could improve antibiotic prescription in this peculiar population. To this end, we propose~     to implement a 3-year prospective, randomized, mono-centric, clinical trial that will~     analyze the impact of systematic TDM on anti-infective agent prescription amongst burned~     patients.~   "
83450|NCT01965080|"~     A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma~      Hypothesis: Treatment With Exemestane can give a response rate of at least 30%~   "
83438|NCT01965249|"~     The major long term complication of abdominal wall closure after a median laparotomy is the~     development of an incisional hernia. Several suture technique and suture material have been~     used but the incidence of this complication still lies between 9 -20%. Synthetic suture~     material which have become available over the last decades have the advantage that they are~     degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of~     their initial strength already after 14-30 days and may not be the optimal suture material~     for abdominal wall closure. A new suture material (Monomax®) was developed with an~     extra-long absorption profile, high elasticity and with a superior initial strength.~     Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length~     on the occurrence of incisional hernia using the extra-long term absorbable, elastic,~     monofilament suture (Monomax®).~   "
83439|NCT01965236|"~     The objective of the present study is to asses the effectiveness of the aorta-ventricular~     coupling according to low and high sodium intake in 28 controled hypertensive patients.~   "
83440|NCT01965223|"~     The main purpose of this study is to determine the safety (defined as number of participants~     experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative~     fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.~   "
83441|NCT01965210|"~     Acute effects on appetite and metabolic function have been observed for whole-grain rye~     cereal products. The aim of this study is to evaluate if the appetite suppressing effect of~     a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable~     dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on~     subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients~     in the blood and products from bacterial fermentation of dietary fibre, and to relate this~     to the different composition of the breakfasts.~   "
83442|NCT01965184|"~     This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive~     behavior such as anger and aggression in children and adolescents. CBT will be compared to~     Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned~     (like the flip of a coin) to receive CBT or SPT. Participants will be also asked to complete~     functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks~     (recordings/images of brain activity) before and after treatment. CBT is a behavioral~     intervention that consists of 12 one-hour long, weekly sessions. During CBT children are~     taught various skills for coping with frustration and parents are taught various strategies~     for managing situations that can be anger provoking for their child. This study is conducted~     to examine whether reduction of behavioral problems including anger outbursts, irritability,~     aggression and noncompliance after CBT may be paralleled by changes in areas of the brain~     responsible for emotion regulation and social perception.~   "
83443|NCT01965171|"~     Red cell transfusions are an important part of supportive cancer therapy. The iron in the~     transfused blood may build up in the body since the human body has no way to get rid of~     extra iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron~     build-up is present many years after completing cancer therapy. It is also not known if~     extra iron causes harm to internal organs. Researchers at St. Jude Children's Research~     Hospital (SJCRH) want to understand if iron build-up (called iron overload) exists in~     survivors of leukemia. They also want to know if iron overload can cause injury to your~     organs if it is present.~      Liver iron accumulation has been documented in childhood cancer survivors, however, it is~     not known if iron associated organ toxicity is contributing to the long-term morbidity that~     has been well documented among these survivors. This study will investigate the prevalence~     of iron overload and the association of tissue iron burden with markers of organ dysfunction~     in leukemia survivors. This study will determine the prevalence of iron overload among~     long-term leukemia survivors that underwent blood transfusion. This study will use blood and~     magnetic resonance imaging (MRI) testing to determine iron overload of specified organs.~     Understanding the prevalence of iron overload could impact surveillance practices in~     leukemia survivors.~      PRIMARY OBJECTIVE:~        -  To determine the prevalence of iron overload in the liver [liver iron concentration~          (LIC) >3mg/g using R2* MRI measurements] and in the heart (T2* <20 ms) among long-term~          leukemia survivors transfused with ≥50ml/kg of packed red blood cells.~      SECONDARY OBJECTIVES:~        -  To examine the relationship between hepatic, cardiac, and endocrine dysfunction and~          transfusionally acquired iron overload as defined by R2* and T2* MRI among survivors of~          pediatric leukemias.~        -  To investigate the association between serum ferritin, transferrin saturation,~          non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron~          overload.~   "
83444|NCT01965158|"~     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the~     treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain~     who are not using laxatives~   "
83445|NCT01965145|"~     The objective of this study is to demonstrate the superiority of gevokizumab as compared to~     placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis~     exacerbations~   "
83446|NCT01965132|"~     We plan to establish a nationwide Biologics Registry (in the form of an inception cohort) to~     study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic~     arthritis patients receiving biologic agents.As this registry is to observe the real world~     use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is~     planned.~   "
83447|NCT01965119|"~     The purpose of this study is that ruxolitinib may be a possible treatment option for~     relapsed or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.~   "
83448|NCT01965106|"~     This study will assess any side effects that may occur when QPI-1007 is injected into the~     eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for~     the body to clear the drug. This study will also test whether QPI-1007, injected into the~     eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of~     visual function in subjects with acute primary angle-closure glaucoma.~   "
83449|NCT01965093|"~     The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is~     desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest.~     Intermittent hypoxic episode especially in infants are also associated with impaired growth,~     longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The~     mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar~     to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia~     for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic~     compounds and increase oxidative stress markers.17 Anesthetic agents which involve~     gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and~     N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause~     neuronal apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups.~     Moreover, prolonged anesthetic exposure, irrespective of open heart surgery, can influence~     neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents~     causing apoptosis and neurodegeneration in human neonatal brain is still not clear.~      Thus, peri-operative desaturation occurred in young age regardless of severity combined with~     general anesthesia might possibly affect the long-term impact regarding growth and~     neurodevelopmental outcome in infant or intelligence outcome in older children. In our~     study, we are interested in looking at the intelligence outcome, which is a part of~     neurodevelopment outcome, in preschool children aged ≤ 5 years who developed desaturation~     peri-operatively. Because we include a wide range of age between newborn to five years old~     to test neurodevelopment outcome in older children, the intelligence outcome may be more~     appropriate and can be applied to infants and younger ages. Therefore, the objective of~     study was to compare intelligence outcome between children who developed peri-operative~     desaturation and children who did not develop PRE.~   "
83451|NCT01965067|"~     The primary efficacy endpoint is the time from the start of administration of sugammadex to~     recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic~     count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C~     and 35°C, and compared with the normal thermal condition.~      Secondary endpoints include time from the start of administration of sugammadex to recovery~     of the TOF ratio to 0.7 or 0.8 in both groups, vital signs [heart rate and blood pressure]~     at pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of~     residual neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse~     events during mild hypothermia and the normal thermal condition.~      We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish~     the efficacy of sugammadex.~   "
83452|NCT01965054|"~     Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in~     abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.~     Women diagnosed with ICP most often present with itching, which may be severe. More~     concerning, however, is the impact of ICP on adverse fetal and pregnancy outcomes, including~     preterm delivery, meconium exposure, fetal demise, and increased neonatal respiratory~     complications. The risk for fetal demise has been estimated to be 1-3%. The mechanism of~     fetal demise in ICP is unknown, and therefore cannot be reliably predicted. There is~     evidence to suggest that extremely elevated bile acids levels are associated with worse~     fetal outcomes, particularly levels greater than 40 μmol/L.~      Ursodeoxycholic acid (UDCA) has anticholestatic effects, and is used to treat a variety of~     cholestatic liver diseases. Many studies have demonstrated superiority of UDCA over other~     agents, including dexamethasone and cholestyramine, for relief of maternal pruritus,~     improvement in transaminitis, reduction in serum bile acid concentrations, and improved~     pregnancy outcomes. As a result, UDCA is now widely used as first-line treatment for~     symptomatic relief in patients with ICP.~      Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are two omega-3 long chain~     polyunsaturated fatty acids found in fish. DHA is known to play a key role in early fetal~     brain development, and has been associated with modest beneficial effects on~     neurodevelopmental and cognitive outcomes in children. In neonates with parental~     nutrition-induced cholestasis (PN-cholestasis), parental fish oil has been shown to be~     hepatoprotective not only for treatment of PN-cholestasis, but for prevention of cholestasis~     in premature infants at risk for the disease. Our hypothesis is that fish oil~     supplementation with DHA in women with ICP who are treated with UDCA will increase the rate~     of decline in serum total bile acid levels.~      The incidence of ICP at a single hospital center in Queens, NY is estimated to be 5%~     secondary to a high concentration of patients from high-risk ethnic groups. High risk~     patients with bile acid levels greater than or equal to 40 μmol/L are managed aggressively~     with inpatient admission for continuous fetal monitoring, treatment with UDCA, and serial~     total bile acid levels weekly. These are patients are routinely offered early delivery after~     documented fetal lung maturity between 36 and 37 weeks gestation, or for any signs of fetal~     distress. This study is a prospective randomized controlled trial comparing weekly serum~     total bile acid levels in women admitted for inpatient management of ICP among women~     supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin~     and DHA.~   "
83453|NCT01965041|"~     Adult-onset vitelliform detachments associated with pattern dystrophy is a genetic disorder~     that carries visual implications that most commonly affect the macula (area in the eye near~     the retina that is essential for sharp central vision). Adult onset vitelliform detachments~     have an accumulation of material on the outer retina. Over time, the abnormal accumulation~     of this material can damage cells that are critical for clear central vision. As a result,~     people with this disorder often lose their central vision, and their eyesight may become~     blurry or distorted.~   "
83454|NCT01965028|"~     Stimulation of the left and right auditory cortex with daily transcranial random noise~     stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.~   "
83455|NCT01965015|"~     The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial~     filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association~     (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed~     to enable a first evaluation of the safety and performance of the V-Wave shunt implant when~     implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with~     intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant~     (baseline) status.~   "
83456|NCT01965002|"~     The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate MR~     guided focused ultrasound surgery in the treatment of soft tissue tumors of the extremities.~   "
83457|NCT01964989|"~     Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus~     Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months~     of Age.~   "
83458|NCT01964976|"~     To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina)~     and biguanides in patients with type 2 diabetes mellitus who responded inadequately to~     treatment with biguanides in addition to diet therapy and exercise therapy.~   "
83459|NCT01964963|"~     The purpose of this study is to examine the safety and efficacy of long-term treatment with~     alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical~     setting.~   "
83460|NCT01964950|"~     The purpose of this study is to examine the safety and efficacy of long-term combination~     therapy with alogliptin (Nesina) and sulfonylurea in patients with type 2 diabetes mellitus~     who responded inadequately to treatment with sulfonylurea in addition to diet therapy and~     exercise therapy.~   "
83461|NCT01964937|"~     This study will evaluate the safety and immune response to five different combinations of~     three HIV vaccines in healthy, HIV-uninfected adults.~   "
83462|NCT01964924|"~     This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene~     homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast~     cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or~     large amounts of human epidermal growth factor receptor 2 [HER2/neu] protein) that has~     spread to other places in the body. Trametinib and Akt inhibitor GSK2141795 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
83472|NCT01964794|"~     Clinically relevant biomarkers for warfarin identified in this study will provide crucial~     leads for subsequent studies to assess their predictive value during anticoagulant therapy.~     This knowledge will aid stratifying risk among patients to improve therapeutic outcomes and~     decrease adverse drug events and associated health care costs. Collectively, these efforts~     will provide a critical foundation for future research using a metabolite biomarker strategy~     in a clinical setting to revolutionize warfarin therapy. Through its application, a~     real−time assessment of warfarin metabolism for each patient could lead to a truly~     personalized dosing strategy and improve patient safety for this life−saving drug.~   "
83734|NCT01961362|"~     To enhance understanding of supplemental oxygen—its utility in and adoption by patients with~     pulmonary fibrosis—by examining how patients perceive it and by determining how perceptions~     and patient-centered outcome measures change from before to after supplemental oxygen is~     prescribed.~   "
83463|NCT01964911|"~     Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in~     hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary~     for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are~     responsible of many side effects. Martorell ulcer arises predominantly in women over 60~     years of age, with history of vascular disease, and therefore with a higher risk of adverse~     event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer~     extension and ischemia.~      This is why pain management is one of the main challenge in treatments of these ulcers.~      Continuous nerve block of lower limbs are often used during per and postoperative~     orthopaedic surgery. Few adverse events and rare serious adverse events related to local~     anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to~     catheter are reported (<1%). Its benefits have been proved on post-operative pain management~     and reeducation.~      The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in~     patients with hypertensive leg ulcer, during hospitalization.~      Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic~     nerve block with ropivacaïne 0,2%, during 7 days.~      Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during~     wound care, maximal and mean. These datas will be collected over two 3-days period : the~     first 3 days of hospitalization, in which pain treatment will be prescribed depending on~     pain intensity of the patient ; and the first 3 days of ropivacaïne treatment.~      The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when~     receiving ropivacaïne.~      Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure~     (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.~   "
83464|NCT01964898|"~     Smoking and depressed mood are both predictive of mortality following Acute Coronary~     Syndrome. However, to date, no counseling treatment has been designed to target smoking~     cessation and manage mood in this population. This trial will test such a treatment based on~     Behavioral Activation, an approach that has shown promise as an integrated treatment for~     smoking and mood management in other populations.~   "
83465|NCT01964885|"~     IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this~     study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive~     medicine, based on its ability to enhance the immune system responses~   "
83466|NCT01964872|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618~     administered for 7 consecutive days in healthy adult male participants.~   "
83467|NCT01964859|"~     This research is being done to determine if we can change skin from one type to another.~     Specifically, we are interested in making normal skin into the thicker skin found on our~     palms and soles.~   "
83468|NCT01964846|"~     The general objective of this project is to investigate the acute effect of consuming a~     dietary supplement combining resveratrol and curcumin on the inflammatory response following~     the consumption of a high-fat meal in healthy subjects with slightly elevated waist~     circumference.~      The study will be undertaken according to a double-blind, cross over, randomized, placebo~     controlled design and will be conducted at the Institute of Nutrition and Functional Foods~     (INAF) of Laval University. The study will involve a total of 20 healthy subjects (10 men~     and 10 women. Included subjects will undergo an 6-hour oral fat tolerance, on two separate~     occasions (one time following dietary supplement consumption and one time following~     consumption of a placebo). The two test days will be separated by maximum of two weeks. The~     outcomes are the changes in the plasma levels of inflammatory cytokines in their gene~     expression.~   "
83469|NCT01964833|"~     The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM~     is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic~     control and increases proteins found in the acute phase of inflammation. The gold standard~     for the treatment of periodontal disease is oral hygiene orientation, scaling and planing.~     Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to~     minimize the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an~     antimicrobial technique and has demonstrated promising results. The aim of the proposed~     study is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in~     the metabolic control of individuals with type 2 diabetes and the reduction of acute phase~     inflammatory markers. The patients will be randomized using a proper software program into~     two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined~     by a specialist, followed by PT performed by two other healthcare professionals. At the end~     of each session, PDT (active or sham) will be administered by a fourth healthcare~     professional. The following will be the PDT parameters: diode laser (660 nm); power output =~     110 mW; exposure time = 90 seconds per point (9 J/point); and energy density = 22 J/cm2. The~     photosensitizer will be methylene blue (50 µg/mL). The patients will be re-evaluated 15, 30,~     90 and 180 days after treatment. Serological exams with complete blood count, fasting~     glucose, glycated hemoglobin and crevicular fluid exams to screen for tumor necrosis factor~     alpha, interleukin 1, interleukin 6, osteocalcin, osteoprotegerin/RANKL will be performed at~     each evaluation. At baseline and 180 day periapical radiographs will be performed to~     evaluate the alveolar bone crest level. The data will be statistically evaluated using the~     most appropriate tests.~   "
83470|NCT01964820|"~     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans~     with depression receive adequate treatment, and one-third of those receiving treatment do~     not benefit. In this pilot project investigators will bring together two approaches that~     have the promise to reach large numbers of depression sufferers: a skills-based intervention~     for increasing positive affect and experiences in depressed individuals, delivered in an~     inexpensive self-paced mobile format. The study will make use of smartphone technology to~     improve conventional outcome measurement via in-the-moment emotion sampling and mobile~     assessment of heart rate variability, a predictor of cardiac health that may mediate some of~     the health effects of depression. The aims are: 1) Retool the existing web-based positive~     emotion intervention for use on smartphones, with innovative exercises that help~     participants bring the skills they are learning into real- life situations; 2) Measure heart~     rate variability and emotions using existing smartphone software; and 3) Perform a~     randomized pilot trial of the mobile intervention on individuals with clinical depression~     recruited online.~   "
83471|NCT01964807|"~     The overarching goal of this project is to develop a panel of cardiovascular risk biomarkers~     that can detect differences in the cardiovascular safety of various tobacco products,~     whether conventional, new or emerging, in order to help the FDA with the task of regulating~     them. This will be achieved through 4 aims:~      Aim 1: Determine the relative contributions of nicotine and combustion products to the~     cardiovascular risk of active cigarette smoking.~      Aim 2: Determine which cardiovascular risk biomarkers are affected by exposure to secondhand~     smoke.~      Aim 3: Determine the cardiovascular risk of smokeless tobacco use. Aim 4: Determine the~     cardiovascular risk of electronic cigarettes and the respective contributions of nicotine~     and electronic cigarette vapor.~   "
83847|NCT01959880|"~     The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's~     Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation,~     primary reconstruction, or revision. Safety information on the rate of capsular contracture,~     rupture and infection will be collected and used to determine device safety.~   "
83473|NCT01964781|"~     After surgical procedures, interventions to reduce postoperative pain and bleeding are of~     great importance. In this study, the effect will be investigated of smearing common drugs,~     which are designed for injection, directly onto the raw wound surface (topical application)~     created during surgery. Topical application allows a small amount of drug to reach a large~     wound area, higher drug concentration in the exposed wound surface but very low~     concentration in the body, and no risk of injury from needles. Although beneficial effects~     of such an easy and low-cost intervention would be expected, the investigators have found no~     previous reports on blinded and controlled studies.~   "
83474|NCT01964768|"~     A Phase III study to determine the sensitivity and specificity of three solutions of~     different allergen extracts for diagnosis by skin prick-test:~        -  5 Grasses pollen,~        -  Birch pollen,~        -  Dermatophagoides pteronyssinus mite~   "
83475|NCT01964755|"~     By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to~     induce remission in this generally fatal disease. Most therapies for aggressive B cell~     lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone~     marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell~     infusion) that are difficult to implement in heavily pre-treated patients. Therapy for~     relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt~     Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after~     stem cell transplant failure. The investigators propose a novel therapeutic approach that~     exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated~     suppression of NF-kB and disruption of viral latency.~   "
83476|NCT01964742|"~     The treatment of HCV (hepatitis C virus) infection has made significant progress over the~     past decade with the therapy combining pegylated interferon (Peg-IFN) to ribavirin (RBV).~     The cure of HCV infection which consists to obtain a sustained virological response (SVR)~     (undetectable HCV RNA 24 weeks after end of treatment) is reached in more than 50% of~     patients infected with HCV. However, this rate is much lower, around 30 to 40% in HIV-HCV~     co-infected patients and sometimes can be less than 20% for patients infected with HCV~     genotype 1. Haemolytic anemia is a dose-limiting adverse effect which occurs frequently~     under RBV therapy. RBV-induced anemia represents the main cause of treatment discontinuation~     or dose reduction of RBV, thus limiting the chances of achieving a SVR. RBV has a large~     inter-individual pharmacokinetic variability and a relationship between the occurrence of~     anemia and RBV concentration was clearly demonstrated. However, other factors, including~     genetic factors, could be predictive of hematotoxicity and/or a better efficiency. In~     particular, IL-28B polymorphism analysis, in patients infected with HCV genotype 1, before~     starting antiviral therapy could predict the response to treatment (positive predictive~     value). The genetic polymorphism of inosine triphosphate pyrophosphatase (ITPA) is also~     strongly associated to a protective effect towards the RBV-induced-anemia. But most of these~     data are issued from studies performed in a Japanese HCV mono-infected population treated~     with Peg-IFN-RBV therapy for which there is no other causal variant that the rs1127354. Only~     few studies are reported in the literature in caucasian HIV-HCV co-infected patients.~     Moreover, data on RBV plasma exposure are very scarce in all these studies showing an impact~     of the ITPA polymorphism on the occurrence of anemia. In addition, others polymorphisms of~     SCL29A1/A2 and SCL28A2/A3 coding for RBV transporters, ENT (equilibrative nucleoside~     transporter) et CNT (concentrative nucleoside transporter) would be associated to either~     rapid virological response or anemia in HCV infected patients treated by Peg-IFN plus RBV.~     No study considering both polymorphisms of ITPA, IL-28B, SCL29A1/A2 and SCL28A2/A3 genes and~     RBV plasma exposure data has so far been conducted in HIV-HCV co-infected patients.~      Thus, it would be interesting in a first time to assess the impact of the ITPA polymorphism~     on both the RBV plasma exposure and the protective effect towards RBV-induced anemia in~     HIV-HCV co-infected patients. This study could be helpful to the literature for possible~     further RBV dose adjustments according to ITPA activity.~      Then, it would be relevant to further complete these data by assessing other genetic~     polymorphisms as IL-28B, SCL29A1/A2 and SCL28A2/A3 and thus evaluate the overall~     pharmacogenetic relationships towards RBV-induced anaemia and/or virological response to a~     Peg-IFN/RBV therapy.~   "
83477|NCT01964729|"~     The purpose of this study is to investigate if rTMS may have a positive impact on pain~     thresholds and cortical excitability in subjects with chronic musculoskeletal diseases of~     complex cranio-cervical-mandibular with myofascial component.~   "
83478|NCT01964716|"~     This study will compare the immune responses of the infants who have been given 13vPnC in~     the mutidose vial formulation to the immune reponses of the infants who have been given~     13vPnC in the single-dose syringe formulation.~      It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all~     infants who are vaccinated.~   "
83479|NCT01964703|"~     The purpose of this study is to determine whether Rubus occidentalis extract could improve~     fasting or postprandial serum glucose levels, and related metabolic markers among patients~     with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).~   "
83480|NCT01964690|"~     Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very~     interesting to detect those situations. Usually, lactate used is arterial but results are~     often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some~     analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.~      We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect~     earlier those infections states and we want to find the most accurate site to detect severe~     sepsis (capillary, venous or arterial sample).~   "
83481|NCT01964677|"~     The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device~     for the palliation of pain in patients with bone metastases.~      Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses~     ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the~     method is due to local bone denervation, caused by the heat denaturation of the periosteum~     layer in the treated area. The importance of this therapy is that it offers a non-invasive,~     focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation~     therapy or the need for needle insertion as with radio-frequency(RF)ablation.~      The study hypothesis is that MR-HIFU will be effective in treating the pain associated with~     bone metastases~   "
83482|NCT01964664|"~     The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation~     intervention or audio training improves performance on an adaptive communication system that~     utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces~     stress in subjects with severe speech and physical impairments (SSPI).~      Hypothesis: The group of subjects randomized to the mindfulness meditation training will~     improve BCI performance and stress levels more than the audio control group.~   "
83483|NCT01964651|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral~     dose administration.~   "
83525|NCT01964105|"~     The purpose of this trial is to evaluate the impact of incorporating three-dimensional~     (3D)imaging during preoperative consultation on patient reported outcomes in primary breast~     augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to~     share with images how one could look after one's procedure. The patient's assessment will be~     collected using the Breast Q, an objective questionnaire that captures patient satisfaction~     with breast augmentation.~   "
83484|NCT01964638|"~     This is a prospective single center trial to examine the rates of cancer diagnosis when~     using computerized software to target suspicious lesions within the prostate identified on~     mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using~     software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use~     of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis~     being tested is that fusion guided biopsy will increase detection prostate cancer within~     mpMRI findings as compared to visual guided biopsy of these areas~   "
83485|NCT01964625|"~     Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major~     intrinsic complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT).~     Moreover, chronic GvHD may be regarded as a late effect of cancer therapy, and the~     severity of chronic GvHD is the chief determinant of long-term survival following allo-HSCT.~     Unfortunately, the investigators understanding (and thus management) of chronic GvHD is not~     optimal; a recent NIH Consensus Conference has defined inadequacies in virtually all facets~     of chronic GvHD management. Notably for this study, the lack of suitable biomarkers~     compromises diagnosis, staging and therapeutic response evaluation of chronic GvHD - and~     also hinders better understanding of the biology of this process.~      In particular, the activity of chronic GvHD is often difficult to discern, potentially~     causing either undertreatment, with the risk of morbidity and/or mortality due to~     uncontrolled chronic GvHD, or possibly overtreatment, with potent ISTs causing unnecessary~     toxicity. Obviously, the development of reliable biomarkers of chronic GvHD activity would~     be a very useful advance in addressing this problem, as well as other facets of management~     not addressed due to certain limitations, as detailed herein.~      Potentially, certain imaging technologies could address this problem. To date, imaging~     technology has been used only sporadically in chronic GvHD and is not an integral part of~     routine assessments. However, and despite its nonspecific nature, certain inflammatory~     features of some chronic GvHD cases, plus clinical similarity to certain autoimmune diseases~     in which functional imaging has been tested in research trials - (and perhaps notably), a~     limited experience in acute GvHD - the investigators postulate that Positron emission~     tomography - computed tomography (PET-CT) scans may be useful as a biomarker of disease~     activity in chronic GvHD. This protocol is an initial effort to that end.~   "
83486|NCT01964612|"~     Patient with chronic disease learning of a chronic illness quickly changes the way they~     encounter in physiological, psychological and social aspects. The investigators research~     purposes will use the meta-cognitive approach to explore adjustment to life-threatening~     illness (ex. hypertension and diabetes) of patients may find the important factors in their~     coping process.~   "
83487|NCT01964599|"~     The primary physiological impacts of fiber intake include the gastrointestinal effects of~     stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT).~     Fermentation of resistant starches by microbiota increases bacterial numbers, which~     increases fecal bulk and may impact frequency and transit time. The purpose of this study is~     to determine the effects of resistant potato starches (potato fiber) on stool frequency,~     transit time and microbiota in healthy individuals.~   "
83488|NCT01964586|"~     It is very important to decrease the bleeding during nasal septoplasty in order to increase~     the visibility of the surgical site. Our primary goal was to investigate the effects of~     dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and~     postoperative analgesic consumption.~   "
83489|NCT01964573|"~     The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose~     applications of the Rotigotine transdermal patch in healthy young male and female Korean~     subjects to be submitted to MFDS for new drug application approval.~   "
83490|NCT01964560|"~     Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in~     addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18~     years who currently have uncontrolled partial onset seizures.~   "
83491|NCT01964547|"~     A study to compare the change in cognitive performance and psychological status of patients~     with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to~     existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to~     evaluate the effect of Sativex on mood and spasticity and to assess the safety and~     tolerability of Sativex.~   "
83492|NCT01964534|"~     To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.~   "
83493|NCT01964521|"~     An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF,~     investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using~     mepilex transfer Ag as intended.~   "
83494|NCT01964508|"~     Thyroid cancer is the most common endocrine malignancy and its incidence is rapidly~     increasing. Palpable thyroid nodules are very common, affecting up to 5% of the general~     population. Nevertheless, only 5% of the thyroid nodules harbor malignancy, hence the~     obvious need to accurately characterize these nodules. Ultrasound guided fine needle~     aspiration biopsy (FNAB) is the most important tool in assessing the nature of thyroid~     nodules, however, in up to 30% of the biopsies the results are indeterminate. In this~     proposal, we hypothesize that leftover cells in the FNAB needle may be utilized for~     molecular analysis with an established microRNA panel and distinguish between malignant and~     benign lesions. Despite established studies on the diagnostic utility of microRNAs in~     thyroid nodules, the effect of microRNAs on specific target genes involved in thyroid cancer~     is poorly studied. In this proposal we hypothesize that the microRNAs identified in our~     panel will affect intracellular pathways by regulating target genes that are involved in~     thyroid tumorigenesis. We present preliminary data that confirms that microRNA panel may~     identify malignancy in thyroid nodules. In aim 1 we will identify the expression profile of~     miRNAs in the different thyroid cancers. We will statistically quantify the threshold of~     miRNA dysregulation for malignancy on a large number of tumor and benign samples. This will~     serve as matrix for defining malignancy on the FNAB samples. In aim 2 we will establish a~     reliable reproducible method to extract RNA from cells left over in FNAB samples. Our~     preliminary data support the feasibility of the method and it has not been described~     previously. This will be the first study that will compare cytology results and microRNA~     panel analysis on the very same FNAB cells. It will mimic the exact clinical scenario that~     such microRNA panel can be utilized in the future. Finally, in aim 3 we will characterize~     the effect of microRNAs on target genes expression. We will identify possible target genes~     from bioinformatics databases and will perform quantitative measurement of mRNA level of~     target gene by real time PCR and immunohistochemistry. These studies will hopefully support~     the utility of microRNAs as a diagnostic tool to accurately identify malignancy in thyroid~     FNAB leftover cells and point out possible target genes for future therapeutic approaches.~     This could impact many patients, as thyroid cancer is the 5th most common cancer in women,~     and the most rapidly growing malignancy in both men and women.~   "
83495|NCT01964495|"~     The purpose of this study is to evaluate two different treatment strategies in patients~     admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize~     treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be~     effective in reducing the length of antibiotic treatment.~   "
83512|NCT01964274|"~     In this prospective, multicenter observational study the investigators capture the~     perioperative course of peripheral cholinesterase activity. The focus is the perioperative~     inflammation causing postoperative delirium. Therefore we measure the activity of~     Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the~     perioperative context. Early postoperative delirium will be detected by Nu-DESC in the~     Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase~     activity will be compared with the incidence of postoperative delirium and other clinical~     dysfunctions.~      We follow up the patients for up to five years regarding Delirum, comorbidities and~     mortality data.~   "
83496|NCT01964482|"~     The project aims to investigate the clinical value of simple strength training during~     hospitalization and after discharge as part of an enhanced recovery programme for acutely~     admitted older medical patients, in order to prevent mobility decline following acute~     hospitalization.~      Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained~     funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve~     sufficient power to look more deeply into our secondary outcomes. This will constitute a~     secondary part of the trial (started Nov. 2016). The primary trial report will include data~     for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence,~     the primary completion date for part 1 was April 2016 and the study completion date for part~     1 was Oct 2016. The trial status is still recruiting although this applies to part 2 of~     the study.~   "
83497|NCT01964469|"~     This study is to compare Smart phone mobile device and/or web based application asthma~     action plan to the standard of care paper based asthma action plan within an asthma program.~     The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application~     improves asthma related quality of life more than conventional best practice~   "
83498|NCT01964456|"~     The purpose of this study is to demonstrate that bodily self-consciousness is subjectively~     and inter-subjectively constituted and that some dimensions of the bodily self-consciousness~     are impaired in Anorexia nervosa.~   "
83499|NCT01964443|"~     The purpose of this study is to explore the impact of plaque psoriasis on the different~     dimensions of patient life including psychological disorders, different types of addictions,~     and their consequences on health-related quality of life and socioeconomic parameters at~     baseline (cross-sectional part) and during the initial years of the psoriasis disease~     (longitudinal part).~   "
83500|NCT01964430|"~     The purpose of this study is to compare whether there is a delay or prevention of recurrence~     or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel~     in combination with gemcitabine compared to those who take gemcitabine alone.~   "
83501|NCT01964417|"~     The purpose of this study is to compare the efficacy, acceptability and preparation-induced~     mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.~   "
83502|NCT01964404|"~     Substance use disorders are strikingly common in patients with schizophrenia and contribute~     to its morbidity and cost to society. We have proposed a neurobiological formulation~     suggesting that cannabis and other substance use in these patients may ameliorate a~     dysfunction in the brain reward circuit(thus serving a self-medication function), while~     also worsening the symptoms and course of schizophrenia.~      In this translational research proposal, based on our formulation, we seek to confirm and~     expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid~     agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring~     cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in~     these patients and, thereby, provide evidence in support of the role of cannabis as a~     self-medication agent for them. Also, by also testing the full range of effects produced~     by dronabinol (effects on brain reward circuitry assessed with task-based function MRI and~     resting state connectivity), as well as on reward responsiveness, mood, craving, cognition,~     psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol~     should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to~     limit cannabis use in patients with schizophrenia.~      Substance use disorders are strikingly common in patients with schizophrenia and contribute~     to its morbidity and cost to society. We have proposed a neurobiological formulation~     suggesting that cannabis and other substance use in these patients may ameliorate a~     dysfunction in the brain reward circuit(thus serving a self-medication function), while~     also worsening the symptoms and course of schizophrenia.~      In this translational research proposal, based on our formulation, we seek to confirm and~     expand upon our pilot data suggesting that cannabis and the cannabinoid agonist dronabinol,~     given in low dose to patients with schizophrenia and co-occurring cannabis use disorder,~     will in fact ameliorate the brain reward circuit dysregulation in these patients and,~     thereby, provide evidence in support of the role of cannabis as a self-medication agent~     for them. Also, by also testing the effects produced by dronabinol (effects on brain reward~     circuitry assessed with task-based function MRI and resting state connectivity), as well as~     on reward responsiveness, mood, craving, cognition, psychiatric and extrapyramidal~     symptoms), we will provide clues as to whether dronabinol should be tried in low doses as an~     adjunctive agent (with an antipsychotic medication) to limit cannabis use in patients with~     schizophrenia.~      This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of~     schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7~     will have cannabis use disorder only and Group 8 will be healthy control participants.~     Following screening and baseline neuropsychiatric testing, participants will have two tests~     days (T1 and T2) that will include task-based functional MRI, including assessment of~     resting state connectivity, and measuring a number of other parameters including reward~     responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be~     virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly~     assigned to one of the following conditions prior to the assessments: receiving 15mg of~     dronabinol and smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a~     real marijuana cigarette, or receiving a placebo pill and smoking a placebo marijuana~     cigarette. Group 4 and Group 8 will receive no drug or placebo at T2. Participants receiving~     drug will have safety assessments before the drug is administered, after the drug is~     administered but before leaving the research clinic for the day, and again a week later.~   "
83503|NCT01964391|"~     This phase IIIb, open-label, multinational, multicenter study will evaluate the patient's~     satisfaction and safety with subcutaneously administered Herceptin (trastuzumab) in patients~     with HER2-positive early breast cancer. Patients will receive Herceptin 600 mg administered~     subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18~     cycles (1 year), unless disease progression or unacceptable toxicity occurs. The Herceptin~     regimen could include mono- and/or combination therapy.~   "
83504|NCT01964378|"~     Pain is one of the most common symptoms associated with malignant tumor. The purpose of this~     trial is to determine whether cebranopadol is as effective in patients with cancer related~     pain as morphine sulfate prolonged release.~   "
83505|NCT01964365|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between rosuvastatin and fenofibric acid in healthy adult subjects~   "
83506|NCT01964352|"~     The objective of this study is to assess the efficacy and safety of 12 weeks once daily~     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat~     inhaler) compared with tiotropium and placebo in patients with COPD.~   "
83507|NCT01964339|"~     This is an observational study to characterize the prevalence of Obesity Hypoventilation~     Syndrome in patients referred to the sleep lab.~   "
83508|NCT01964326|"~     The purpose of this actual use study is to simulate the over the counter use of atorvastatin~     calcium 10 mg.~   "
83509|NCT01964313|"~     To describe the role of genetic factors and its relationship and interaction with~     environmental factors in the recurrence of cardiac events in Chinese patients with acute~     coronary syndrome.~   "
83510|NCT01964300|"~     This phase II trial studies how well peginterferon alfa-2b works in treating younger~     patients with craniopharyngioma that is recurrent or cannot be removed by surgery.~     Peginterferon alfa-2b may interfere with the growth of tumor cells and slow the growth of~     craniopharyngioma.~   "
83511|NCT01964287|"~     Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen~     is more effective and tolerate than the treatment by Gemcitabine alone in patients with~     metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab~     paclitaxel improve the objective response rate.~      Primary objective of this study is to identify the maximun tolerated dose and the~     recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel~     followed by folfirinox in metastatic pancreatic adenocarcinoma.~   "
83526|NCT01964092|"~     Roughly one third of disability pensions issued in Norway are classified as mental and~     behavioral disorders. The proposed study aims to evaluate the effect of an innovative~     intervention for returning people with moderate to severe mental health disorders to work:~     Individual Placement and Support (IPS).~   "
83513|NCT01964261|"~     This research study is being conducted to develop a brain controlled medical device, called~     a brain-machine interface. The device will provide people with a spinal cord injury some~     ability to control an external device such as a computer cursor or robotic limb by using~     their thoughts along with sensory feedback.~      Development of a brain-machine interface is very difficult and currently only limited~     technology exists in this area of neuroscience. Other studies have shown that people with~     high spinal cord injury still have intact brain areas capable of planning movements and~     grasps, but are not able to execute the movement plans. The device in this study involves~     implanting very fine recording electrodes into areas of the brain that are known to create~     arm movement plans and provide hand grasping information and sense feeling in the hand and~     fingers. These movement and grasp plans would then normally be sent to other regions of the~     brain to execute the actual movements. By tying into those pathways and sending the movement~     plan signals to a computer instead, the investigators can translate the movement plans into~     actual movements by a computer cursor or robotic limb.~      A key part of this study is to electrically stimulate the brain by introducing a small~     amount of electrical current into the electrodes in the sensory area of the brain. This will~     result in the sensation of touch in the hand and/or fingers. This stimulation to the brain~     will occur when the robotic limb touches the object, thereby allowing the brain to feel~     what the robotic arm is touching.~      The device being used in this study is called the Neuroport Array and is surgically~     implanted in the brain. This device and the implantation procedure are experimental which~     means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport~     Array consists of a small grid of electrodes that will be implanted in brain tissue and a~     small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This~     pedestal is designed to be attached to the skull and protrude through the scalp to allow for~     connection with the computer equipment. The top portion of the pedestal has a protective~     cover that will be in place when the pedestal is not in use. The top of this pedestal and~     its protective cover will be visible on the outside of the head. Three Neuroport Arrays and~     pedestals will be implanted in this study so three of these protective covers will be~     visible outside of the head. It will be possible to cover these exposed portions of the~     device with a hat or scarf.~      The investigators hope to learn how safe and effective the Neuroport array plus stimulation~     is in controlling computer generated images and real world objects, such as a robotic arm,~     using imagined movements of the arms and hands.~   "
83514|NCT01964248|"~     The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne~     versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a~     numeric Pain Intensity for all patients included.~   "
83515|NCT01964235|"~     This study is establish whether INC280 is safe and has beneficial effects in patients with~     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose~     disease progressed while on, or after, treatment with sorafenib or who are intolerant to~     sorafenib.~      Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best~     supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study~     treatment. Patients treated with placebo plus BSC will have the opportunity to receive~     INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's~     discretion after unblinding.~      Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden~     (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).~   "
83516|NCT01964222|"~     This study will update an existing health literacy intervention (decision aid) for informed~     consent procedures and then conduct a randomized experiment implementing the health literacy~     intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care.~     Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to~     usual care will increase knowledge about cancer clinical trials. Secondary outcomes include~     patients' ability to communicate with health care providers about trials, willingness to~     participate in trials, and enrollment rates for minority participants.~   "
83517|NCT01964209|"~     This proposal is to evaluate the reliability and validity of the Vanderbilt ADHD screening~     tool for use with adolescents and young adults aged 13-21 years. The Vanderbilt is a~     previously developed, freely available set of parent- and teacher-report questionnaires~     designed to identify ADHD and related disorders in children. The Vanderbilt measures have~     been chosen for inclusion in the new computerized Integrated Clinical Information Sharing~     System (ICISS) being rolled out in five Boston Children's Hospital (BCH)~     departments/divisions (Adolescent/Young Adult Practice, Children's Hospital Primary Care~     Center, Developmental Medicine Center, Department of Neurology, Department of Psychiatry).~     The Vanderbilt was developed and validated for use among children up to age 12 years~     (Wolraich et al., 2003; Wolraich et al., 2013; Bard et al., 2013), and little is known about~     its appropriateness for use among older youth. In addition, there is no self-report version~     of the Vanderbilt that can be administered directly to adolescents and young adults (ages~     13-21 years), for whom parents and teachers are often less knowledgeable reporters. To~     address these shortcomings, a multidisciplinary team of BCH adolescent health clinicians and~     researchers modified the parent and teacher Vanderbilt questionnaires to make them~     age-appropriate for adolescents and young adults and created a complementary self-report~     version for adolescents and young adults. The goal of the current study is to 1) assess the~     feasibility and acceptability of online administration through the ICISS system of the new~     parent, teacher, and youth self-report Vanderbilt measures among adolescent and young adult~     BCH patients aged 13-21 years; 2) test their reliability in terms of internal consistency~     reliability, temporal stability of responses over a one-month test-retest, and inter-rater~     agreement across all informants (parents, teachers, and youths); and 3) test their validity~     by evaluating their convergence with a similar set of ADHD screening tools, the Conners~     scales, already validated for use with adolescents and young adults.~   "
83518|NCT01964196|"~     This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of~     anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied~     intermittently.~   "
83519|NCT01964183|"~     To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects~     on the pharmacokinetics (PK) of tolterodine and its metabolites.~      In addition, the safety of these products will be assessed.~   "
83520|NCT01964170|"~     To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate~     cancer.~   "
83521|NCT01964157|"~     ROS1 is a receptor tyrosine kinase with constitutive kinase activity. ROS1 was previously~     discovered in cell lines where ROS1 fused with other proteins to act as a driver oncogene.~     In 2007, Rikova et al reported ROS1 fusion as driver mutations in NSCLC cell line (HCC78;~     SLC34A2-ROS1) and NSCLC patient (CD74-ROS1). Li et al also found about 1% of samples~     harboring CD74-ROS1 fusion in 202 resected lung adenocarcinomas from never smokers. The~     incidence was as high as 10% in East Asian population. Currently there are now at least 13~     ROS1 fusion variants involving 8 fusion partners (CD74-, SLC34A2-, FIG-, TPM3-, SDC4-,~     LRIG3-, ERZ-, KDERL2-) identified in ROS1 positive NSCLC. LDK378 is an orally highly~     selective and potent ALK kinase inhibitor. In preclinical studies, LDK378 has much lower~     IC50 values than crizotinib in cell lines engineered to express ROS1 rearrangement (0.15 nM~     versus 3 nM) and is approximately 20-fold more potent. LDK378 is a potent inhibitor of tumor~     growth in rodent models of both ALCL and NSCLC. We suggest a phase II trial of LDK378 in~     advanced non-small cell lung cancer patients with ROS1 rearrangement. The aim of current~     trial is to evaluate the antitumor efficacy and safety profile of LDK378 and to identify~     biomarker to predict the tumor response to LDK378.~   "
83522|NCT01964144|"~     There has been no effective treatment for advanced thyroid cancer that is not amenable to~     surgery and that does not concentrate iodine. Response rates with chemotherapy have been so~     low that best supportive care has been the standard of care for most patients. In recent~     phase I and phase II clinical studies, dovitinib has shown activity as a single agent in~     solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the~     efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid~     cancer.~   "
83527|NCT01964079|"~     Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP~     lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for~     hypertension are mainly focused on lowering mean BP. However, despite an increasing~     incidence of stroke with age, the association between systolic BP (SBP) and the risk of~     stroke decreases with age. This disparity highlights a gap in the link between BP and~     vascular-related diseases (i.e., stroke). In clinical practice, visit-to-visit fluctuations~     in BP have been largely ignored and are thought to be an unreliable finding, even though~     this phenomenon is frequently observed. Rothwell et al. demonstrated that the visit-to-visit~     variability in SBP was a more powerful independent predictor of stroke than mean SBP, and~     that an increased residual variability in SBP in treated hypertensive patients was also a~     strong predictor of stroke and coronary events.~      Recently updated (2011) hypertension guidelines from the National Institute for Health and~     Clinical Excellence (NICE) recommend an angiotensin converting enzyme inhibitor (ACEi) [or~     angiotensin II receptor blocker (ARB)] and calcium-channel blocker (CCB) as a first line~     drug. Although the significance of BP variability (BPV) has been illustrated, the main focus~     of the current guidelines is to reduce systolic and diastolic BP, not BPV.~      In the X-CELLENT study, a CCB (amlodipine) and thiazide-like diuretic drug (indapamide~     sustained-release) led to a significant reduction in BPV, compared to an ARB (candesartan).~     In addition, the CCB showed the most effective reduction in systolic BPV among the~     antihypertensive drug class in a meta-analysis. However, there are no direct comparison~     studies of a CCB and ARB on BPV. Thus, we aim to compare the systolic BPV effects of a CCB~     versus an ARB in essential hypertensive patients. The primary hypothesis is that an ARB is~     not inferior to a CCB in the reduction of the systolic BPV standard deviation (SD) in~     essential hypertensive patients.~   "
83528|NCT01964066|"~     For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis~     has been the most frequent adverse effect of endoscopic transpapillary interventions. We~     sought to determine the efficacy of thoracic epidural analgesia for the prevention of~     post-ERCP pancreatitis.~      Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491~     patients was conducted. The first group of patients (N=247) received thoracic epidural~     analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a~     narcotic analgesic. To detect statistically significant differences between research groups~     adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.~   "
83529|NCT01964053|"~     Non-adherence to self-management behaviors is prevalent and accounts for hospital~     readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to~     activate and engage HF patients in managing their own care is uncertain. Yet post-acute care~     service that is vital to improve HF patients' self-management adherence and HF outcomes is~     suboptimal in rural hospitals (primarily critical access hospitals). The investigators~     central hypothesis is that patients with higher activation level will have significantly~     better self-management adherence. This study will test whether Patient AcTivated Care at~     Home (PATCH) will improve self-management adherence and health outcome (reduced hospital~     readmissions), as well as the feasibility to translate the research findings to a home based~     post-acute care service in rural communities.~   "
83530|NCT01964040|"~     The duration of sensory block after single dose of long acting local anesthetics is not~     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as~     clonidine have been shown to increase the duration of peripheral nerve block.~     Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To~     the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was~     not previously reported for femoral nerve block.~   "
83531|NCT01964027|"~     This study is to determine the response rate and safety profile of irinotecan plus~     epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate~     the feasibility and effectiveness of the regime.~   "
83532|NCT01964014|"~     The objective of this study is to assess the efficacy and safety and Immunosuppressant~     Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients~     who had kidney transplantations earlier.~   "
83533|NCT01964001|"~     Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second~     cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as~     antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of~     this study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the~     indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers~     in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study.~     The investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are~     identified by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50~     mg/d), coenzyme Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups.~     Intervention is going to administration for three months. The concentrations of vitamin B-6,~     coenzyme Q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant~     vitamins (vitamin A and E), and inflammatory markers are going to be analyzed. The results~     would provide more information nutrients for clinical physicians and dietitians for~     considering suggesting patients with HCC using vitamin B-6 or coenzyme Q10 supplementation~     to improve their clinical outcomes.~   "
83534|NCT01963988|"~     On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain~     syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of~     ulcer.~      But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in~     ulcer type BPS patients.~      We assume TUR have a more therapeutic effect than TUC.~   "
83535|NCT01963962|"~     The purpose of this study is to see how often women who come to a family planning clinic for~     emergency contraception, the morning after pill, are willing to use either the copper IUD or~     the levonorgestrel IUD. The investigators will also see if pregnancies occur in those~     choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.~   "
83536|NCT01963949|"~     To collect tumor tissue from patients with liver masses suspicious for primary liver cancer.~     The research biopsy will be used to identify biomarkers in future studies.~   "
83577|NCT01963416|"~     Acute, randomized, placebo controlled, double blind, postprandial crossover study in male~     subjects. 4 intervention arms consisting of control, orange juice, whole orange, and~     processed whole orange to determine the effect of the interventions on the primary measure~     of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also~     identify and quantify the main micronutrients and phytochemicals in each of the products and~     will identify and quantify the main micronutrients and phytochemicals and their metabolites~     in the subjects' plasma and/or urine. A subset of the study population (n=24) will be~     invited to participate in an additional arm of the main study which is summarised below.~   "
83537|NCT01963936|"~     Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be~     effective for ventilating newborns at birth. The LMA may be considered as an alternative to~     FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34~     weeks' gestation.~      A recent, quasi-experimental study provided the feasibility, efficacy and safety of using~     the LMA in neonatal resuscitation.~      However, studies of LMA use for providing PPV during neonatal resuscitation are still~     limited. There are no published clinical randomized trials evaluating the LMA compared with~     the FM for neonatal resuscitation.~      Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV~     with a LMA will be more effective than ventilating with a FM by decreasing the proportion of~     resuscitated newborns needing ETT.~      Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at~     birth.~      Design / Methods: An open, prospective, randomized, single center, clinical trial.~      Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control~     group) in all infant newborns weighing >2000 g or delivered >34 weeks gestation.~      Primary outcome variable: Proportion of newborns needing endotracheal intubation.~      Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and~     10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest~     compressions, drugs and death within 1 week and/or presence of HIE, grade II or III,~     according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE~     grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking;~     grade II (moderate) includes lethargy, seizures, marked abnormalities of tone, and~     requirement of tube feeding; and grade III (severe) includes coma, prolonged seizures,~     severe hypotonia, and failure to maintain spontaneous respiration.~      The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min~     after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt,~     and the number of attempts required to insert the LMA successfully; (3) duration of~     resuscitation: response time (the time period from starting LMA resuscitation to achieving~     an effective response), ventilation time; (4) adverse effects during resuscitation.~   "
83538|NCT01963923|"~     The purpose of this study is to establish the effectiveness of a preoperative pulmonary~     rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted~     thoracic surgery in order to improve exercise tolerance and quality of life. The~     investigators hypothesized that a pulmonary rehabilitation program including both endurance~     and strength training may improve exercise tolerance and quality of life measured with a~     submaximal exercise test and a quality of life questionnaire respectively.~   "
83539|NCT01963910|"~     Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon~     application. The investigators wish to determine whether mannitol blocks the effect of~     capsaicin application. As both cream bases are identical and mannitol addition is the only~     difference between the creams, if the mannitol cream is more effective in blocking the~     effect of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the~     investigators will have established that mannitol down-regulates or blocks the TRPV1~     (transient receptor potential vanilloid 1) receptor.~   "
83540|NCT01963897|"~     The study will give a consent based epidemiological overview of Norwegian patients with~     Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be~     described. Longitudinal development of growth, bone health, and , when applicable, puberty~     over a two year period will be studied. Questionnaires regarding quality of life will also~     be an important part of the study.~   "
83541|NCT01963884|"~     In patients that are going to be subjected to a tooth extraction in the anterior maxillary~     (from canine to canine) does the position of the intact alveolar socket related to maxillary~     basal bone interferes with the rate of resorption and remodeling process of the alveolar~     ridge ?~   "
83542|NCT01963871|"~     The purpose of this study is to determine if yoga is an effective intervention in treating~     individuals with chronic low back pain (LBP).~   "
83543|NCT01963858|"~     Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is~     the most common reason for low acceptance of colonoscopy. Several methods have been used to~     minimize patient discomfort, including the use of paediatric colonoscopes, variable~     stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the~     patients to participate in administration of medication. Although a potential benefit from~     some of these methods has been suggested, no clear recommendations have been made so far. We~     hypothesized functional relaxation reduces discomfort during colonoscopy.~   "
83544|NCT01963845|"~     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from~     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver~     disease that can lead to cirrhosis and liver-related mortality in persons who drink little~     or no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of~     hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the~     presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or~     without fibrosis. NASH is benign in many affected individuals but can cause progressive~     liver injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there~     is no FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but~     often difficult maintain these lifestyle changes in the long term and therefore therapeutic~     agents have been investigated. In this study, we propose to treat 50 patients with NAFLD and~     diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for~     insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day~     of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of~     liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At~     the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an~     optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin~     sensitivity will be compared. The primary end point of successful therapy will be~     improvement in hepatic steatosis measured by MRI. Secondary end points will be improvement~     in insulin sensitivity and liver biochemistry.~   "
83545|NCT01963832|"~     Stroke patients who have little or no voluntary movement in the hand on the more affected~     side of their body more than one year after stroke have few treatment options. This project~     proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for~     patients with such severe impairment in conjunction with an agent, fluoxetine, which has~     been shown in some studies to enhance brain neuroplasticity in response to training.~     Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical~     rehabilitation based on basic research in neuroscience and behavioral science. If the~     project is successful, an efficacious, evidence-based therapy will become available to~     stroke patients for what is now a largely untreated condition~   "
83546|NCT01963819|"~     The aim of this study is to evaluate the potential benefits in implantation, clinical~     pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment.~     Including a follow up on possible pregnancy complications and data on children at birth.~      Further it is planned to aspirate secretions from the uterus and take blood samples during~     the treatment, which presumably can provide information about the mechanisms underlying the~     possible effect of the treatment.~   "
83547|NCT01963806|"~     BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the~     reach of psychotherapeutic interventions by moving selected parts of the therapy into the~     real-life situations causing distress. This randomised controlled trial will investigate the~     effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help~     program for anxiety, supplemented with a tailored smartphone application. The effect of~     added therapist support will also be studied.~      METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder~     and/or panic disorder will be evenly randomised to one of three treatment arms: (1)~     smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT~     without therapist support; or (3) an active waiting list control group with delayed~     treatment. After the 10 week treatment period, the control group (3) will receive the same~     treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder~     7-item self-rating scale. Secondary measures include other anxiety, depression and quality~     of life measures. In addition to pre- and post-treatment measurements, the study includes~     two mid-treatment and two follow-up assessments (12 and 24 months).~      HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be~     superior to the unguided form in reducing anxiety levels, and that both delivery modes will~     be superior to an active waiting-list control group.~   "
83548|NCT01963793|"~     Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically~     Applied Aprepitant in Patients With Prurigo~   "
83549|NCT01963780|"~     To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess~     donor lungs that may not meet current standard donor lung acceptance criteria for~     transplantation.~   "
83550|NCT01963767|"~     Interventions to improve the cognitive health of older adults are of critical importance. In~     the current protocol, ithe investigators conducted a short-term (two months) randomized~     clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive~     performance of older adults. Participants were tested with a battery of cognitive tasks at~     baseline and two months after being randomized to the interventional drug or placebo.~   "
83551|NCT01963754|"~     In patients that are going to receive a dental implant in the posterior mandible (distal~     from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 %~     Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?~   "
83552|NCT01963741|"~     Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and~     bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma.~     However, not all allergic rhinitis accompanied with or without asthma treated with~     anti-leukotriene were effective. So it is critical to develop a method to identify the~     response subgroup. In this study, it is assumed that nasal physiological responsiveness to~     leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of~     leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of~     anti-leukotriene agent. The purpose of the study is to establish the methodology and~     diagnostic value of leukotriene D4 (LTD4) nasal provocation.~   "
83553|NCT01963728|"~     To determine if the use of insulin isophane results in improved control of blood sugars~     compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart~     transplantation (NODAT).~   "
83554|NCT01963715|"~     This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in~     adult patients with advanced EGFR-positive tumors.~   "
83555|NCT01963702|"~     Platinum, fluorouracil and taxane based regimen are all acceptable in the first line~     treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used~     in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather~     part of patients can't get benefit from the treatment. It is urgent to find out the~     predictive factors of these regimens in order to get a higher response and better survival~     outcome.~   "
83556|NCT01963689|"~     The aim of this study was to determine whether the use of Ylang Ylang essential oil through~     dermal application or inhalation alters the perception of anxiety and self-esteem and~     physiological parameters such us blood pressure and temperature.~   "
83557|NCT01963676|"~     Investigating the effect of non-invasive transcranial current stimulation on auditory~     hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in~     schizophrenia, so selective targeting of this abnormal activity could serve as a treatment~     for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as~     auditory hallucinations.~   "
83558|NCT01963663|"~     Patients with type 2 diabetes are at an increased risk for developing atherosclerosis,~     largely due to the underlying insulin resistance and chronic low grade inflammation.~     Cardiovascular events could be prevented with proper interventions targeted at ameliorating~     the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and~     chronic inflammatory states has been implicated to have a putative role in both pathways.~     Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that~     anti-diabetes medications are able to modify coronary artery disease risk via direct and~     indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore~     launched to examine the comparative effects of metformin and pioglitazone, two commonly~     prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve,~     newly-diagnosed type 2 diabetes patients.~   "
83559|NCT01963650|"~     The purpose of this study is evaluate the natural course of disease progression related to~     gross motor function in children with metachromatic leukodystrophy (MLD).~   "
83571|NCT01963494|"~     Regular physical activity is one prominent health-protective behaviour which might increase~     with the help of self-regulatory strategies such as action planning.~      The aim of this randomised controlled trial is to examine changes in daily moderate physical~     activity in couples following (a) a dyadic planning intervention, (b) an individual planning~     intervention or (c) a no-planning control condition. Changes in daily physical activity will~     be examined over a period of one year.~      It is assumed that target persons from couples receiving a dyadic planning intervention will~     show greater increases in daily physical activity than target persons from couples receiving~     an individual planning intervention. For couples receiving a dyadic planning intervention or~     an individual planning intervention, it is hypothesized that target persons will show higher~     increases in daily physical activity than target persons from couples participating in the~     no-planning control condition.~   "
83560|NCT01963637|"~     The Gastric bypass (GBP) is actually one of the most performed bariatric procedures~     worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and~     58% EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in~     popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48%~     over 4 years). However, failures are observed because of insufficient weight loss or early~     weight regain. Several hypotheses have been proposed to explain these failures, such as the~     size of the gastric pouch that could be correlated to weight evolution.~      Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric~     pouch is one of the main factors of weight loss failure after GBP or SG due to the loss of~     its restrictive function, the aim of our study is to measure these gastric volumes using~     gastric tomodensitometry with gas, a new reliable,precise and 3 dimension radiological~     technique. The investigators will try to identify a positive correlation between gastric~     dilatation and weight regain.~      Methods This is a 2 year interventional, prospective, monocentric study with longitudinal~     follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG~     (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with~     gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the~     gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric~     pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group,~     the investigators will measure the volume of the gastric tube, of the non resectedantrum, of~     the whole residual stomach and the gastric tube diameter at the middle of the small~     curvature. Volume variations between 3 and 12 months will be compared to the EWL and to~     clinical and metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30%~     dilatation of the neostomach at 12 months will be considered as significant. Reinhold's~     criteria will be used to define surgical failure: EWL<50% at 12 months. Weight regain will~     be considered as significant if the weight reached at 12 months is higher than the minimum~     weight obtained. Gastric volume variation, EWL and BMI evolution between the 3rd and the~     12th month will be analysed in the whole population and in each group (GBP and SG) with a~     Wilcoxon test.~      Expected benefits If the investigators valid the hypothesis that the dilatation of the~     neostomach is an essential factor in weight regain after GBP and SG, the benefit for the~     patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric~     tomodensitometry with gas in order to explain weight regain, and in order to use it as a~     standard. 2/ the identification of specific risk factors related to the surgical procedure~     could result in surgical technique improvements as well as a better adaptation of revisional~     procedures, in order to improve treatment of recurrent obesity.~   "
83561|NCT01963624|"~     The investigators hypothesis is that the combined use of elastography and color doppler~     ultrasonography can increase positive-predictive value of breast screening with ultrasound.~   "
83562|NCT01963611|"~     This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4~     doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing~     Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for~     minimum treatment duration of 40 weeks.~   "
83563|NCT01963598|"~     This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the~     safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients~     with sarcopenia.~   "
83564|NCT01963585|"~     Background:~      Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid~     in the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory~     measures that predict the results of MCT are expected to reduce the number of procedures.~     The possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic~     inflammation, to predict negative or positive MCT in children has not been evaluated.~      Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged~     children and to compare it with markers of airway inflammation: Fractional exhaled Nitric~     Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils).~      Design: Prospective study evaluating these parameters in patients with positive and negative~     MCT.~      Participant selection: The study population included subjects (age range 6 to 18 years)~     referred for Methacholine Challenge Test (MCT)~      Sample size: 130 participants in the two groups. Intervention: Each subject will undergo~     evaluation including a respiratory questionnaire, methacholine challenge test with~     determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline),~     exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count +~     eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour~     visit, with no follow up study visits.~      Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in~     children Secondary outcome parameters: All other parameters are the secondary end points.~   "
83565|NCT01963572|"~     Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's~     life and quality of life (QOL). Although the incidence of cancer is still rising, with the~     promotion of cancer screening and progression of medical technology, its survival rate is~     improving. However, the sequels from cancer or its treatment and the side effects impact the~     patients along with their lives. Breast cancer is the most incident cancer in women with~     high survival rate, continuing care after the diagnosis and treatment is much more needed.~     This study is using breast cancer as an example to establish a continuing service model.~     This study aims (1) to establish a tailored, continuing care model which emphasizes on~     breast cancer patients' function. (2) To investigate the effectiveness of the new care model~     comparing with the control. (3) To find a cutting point of bioelectrical impedance to~     identify late development of lymphedema.~      Methods: This is a randomized-controlled trial expanding for 3 years. Women being newly~     diagnosed with breast cancer and first OPD visit after operation at National Taiwan~     University Hospital will be invited to join the surveillance and care system. Exclusion~     criteria are: younger than 20 years old, stage IV, recurrent or both sides involved, with~     other cancer diagnosis, functional impairments from previous injury or operation on the~     affected upper extremity and other physical or mental problem to influence the test or~     filling the questionnaire. It is estimated there will be 100 subjects participate this study~     every year. After the initial evaluation, they will be randomly allocated to surveillance~     group (SG) or general care group (CG). Totally, in this three-year study, there will be 200~     subjects (100/group), follow-up for 0.5 to 2 years. SG will have health education brochure~     and free class from the first visit post-operatively but CG will only have the brochure.~     Moreover, SG will be screened every time when they visit the clinics. If there is any early~     sign of impairment, professional advice and counseling will be given additionally. In these~     visits, if CG raises any health-related question, they can be answered. Detailed physical~     examination to identify their impairments and QOL are at 3, 6, 12, 18, 24 months after~     operation for both groups. Patients' characteristics, functional status, QOL will be~     presented by descriptive statistics. T-test/Mann-Whitney U test will be used to compare the~     differences between patients in two groups. Survival analysis and log-rank test will be used~     to show the prevalence of various functional impairments and test their difference. ROC~     curve will be used to find the cutting point for prediction of lymphedema.~      Expected Results: It is expected (1) to set up the education program and brochure for breast~     cancer patients. (2) to establish a continuing surveillance and care model for breast cancer~     patients and extending to all cancers. (3) Women in the new care model will have less~     impairment and higher QOL comparing with women at the same post-operative stage. (4) To find~     out the prevalence of functional impairments from the data of control group. (5) A cutting~     point of bioelectrical impedance to identify late development of lymphedema will be found.~     (6) To train the team members of cancer care and research.~   "
83566|NCT01963559|"~     15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of~     amputation and mortality two times greater than that of a diabetic population without DF.~     Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up~     involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced~     Vasodilation (PIV) first observed in healthy subjects after local application of a gradual~     pressure on the skin leading to cutaneous vasodilation at the application of pressure. This~     gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF,~     which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic~     subjects. The main objective of this study is to show that PIV, a functional examination of~     the cutaneous microcirculation we developed, is altered in the presence of DF, taking into~     account the influence of age and neuropathy.~   "
83567|NCT01963546|"~     General anesthesia can be considered as a combination of hypnosis, antinociception and~     immobility. Explore the effect of three kinds of anesthesia,that is the total intravenous~     anesthesia, inhalation anesthesia and inhalation and intravenous anesthesia on stress~     reactions generated by patients with diabetes conducted gastric - bypass surgery , and~     choose a best way from three kinds of anesthesia to control stress reaction of diabetics.~     After selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on~     controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.~   "
83568|NCT01963533|"~     The investigators hypothesize that the age-adjusted telomere length in lung cancer patients~     before chemotherapy may be correlated to comorbidity status and predict outcome. The change~     of telomere length shortening after chemotherapy may relate to treatment side effect and~     treatment response.~   "
83569|NCT01963520|"~     Data from large prospective cohort studies of prosthetic joint infections are lacking.~      Aim of this study: analyzing prospectively the incidence of reinfection in patients with~     prosthetic hip infections who underwent surgery and received antibiotic therapy.~      Hypothesis: to confirm in a large group that the incidence of reinfection after excision~     -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after~     exchange arthroplasty (one or two stage exchange).~   "
83570|NCT01963507|"~     The study aimed to evaluate the chronic effects of resistance training on blood pressure and~     biochemical exams in hypertensive elderlies and the influence of the polymorphism of the~     angiotensin converting enzyme in these response.~   "
83572|NCT01963481|"~     This phase II trial studies how well exemestane and cyclophosphamide work in treating~     patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and~     human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.~   "
83578|NCT01963403|"~     This double-blinded, placebo-controlled, randomized trial will compare the effects of the~     use of a combined oral contraceptive pill to a placebo pill for women who are experiencing~     irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.~      The hypothesis of the study is:~        -  Use of combined oral contraceptive will significantly improve bleeding patterns for~          users of ETG implant~        -  Continuation rate of ETG implant users will be increased by use of combined oral~          contraceptive in women desiring ETG implant removal because of the undesirable bleeding~        -  Adverse events will be uncommon and acceptable to women who use a combined oral~          contraceptive with the ETG implant~   "
83579|NCT01963390|"~     One promising but understudied area in the field of testosterone (T) therapy is its effect~     on metabolism and the development of type II diabetes. Metabolomics is a powerful research~     tool that can detect very early signs of metabolic derangement that may lead to metabolic~     disease. In this observational study, investigators aim to apply metabolomics in order to~     better understand how T therapy influences metabolism. In a clinical population of~     outpatient men with T deficiency investigators will perform comprehensive clinical~     evaluations and also obtain blood for metabolomics. This will be done once prior to T~     therapy and again after 4-6 months of T therapy. Investigators hypothesize that they can~     detect metabolic derangements in men with T deficiency and that these derangements will~     improve with T therapy.~   "
83580|NCT01963377|"~     Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be~     studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through~     aspiration channel of the bronchoscope.~   "
83581|NCT01963364|"~     Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot~     be digested by humans. When eaten they pass through the small bowel to the large bowel, or~     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use~     them as an energy source. This releases energy that humans can absorb, and may have other~     effects on health as well. The process also releases gases such as hydrogen and methane into~     the colon, which will eventually be released as flatulence.~      There is some evidence in animals, and humans, that changing the carbohydrate content of the~     diet may increase the numbers of bacteria in the colon that can use this energy source.~     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect~     transit, the speed at which food and stool moves through the stomach and bowels. This~     undergraduate project will use techniques in Magnetic Resonance Imaging developed in~     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed~     of transit through the bowel and gas production in the colon, and whether there is any~     evidence of a change in the level of signalling chemicals that may affect bowel function.~   "
83582|NCT01963351|"~     This observational trial is designed to assess the safety profile and tolerability of~     bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent~     non-squamous NSCLC.~   "
83583|NCT01963338|"~     The aim of this study was to assess the acceptability and usability of a newly developed~     intradermal device in healthy adults~   "
83584|NCT01963325|"~     This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as~     second-line treatment for cholangiocarcinoma.~   "
83585|NCT01963312|"~     The purpose of this study is to determine whether the transarterial supraselective~     embolization (TSE) is a technique as effective as transurethral resection of the prostate~     (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic~     hyperplasia (BPH).~   "
83586|NCT01963299|"~     This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the~     first will receive ropivacaine alone and the second will receive the association~     ropivacaine/clonidine.~      The aim of the study is to prove that the association of Clonidine with Ropivacaine is more~     effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal~     surgery.~      The principal interest of this association of drugs is that it procures faster and longer~     anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides~     greater comfort to the patient during and after the intervention.~   "
83587|NCT01963286|"~     The purpose of this clinical investigation is the continued assessment of the decision~     accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of~     subjects with primary and secondary prevention of sudden cardiac death.~   "
83588|NCT01963273|"~     The investigators supposed that the complete video assisted ablation of pilonidal sinus~     (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new~     minimally invasive treatment allows the identification of the sinus cavity with its lateral~     tracks, the destruction and the removal of all infected tissue and the removing of any hair.~   "
83589|NCT01963260|"~     The primary objectives of this study are to assess the safety and tolerability of single~     rising doses of MK-8723 in healthy adult participants and adult participants with chronic~     immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in~     participants with ITP.~   "
83590|NCT01963247|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide~     both a noninvasive and portable measure of brain function. The ERPs provide excellent~     temporal information, but spatial resolution for ERPs has traditionally been limited.~     However, by using high-density electroencephalograph (EEG) recording spatial resolution for~     ERPs is improved significantly. The paradigm for the current study will combine~     neurophysiological knowledge with mathematical signal processing and pattern recognition~     methods (BNA™) to temporally and spatially map brain function, connectivity and~     synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~      The BNA test is basically divided to 3 phases - first EEG data is collected from subjects~     using an EEG system while the subject is performing a cognitive task in front of a computer.~     The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the~     BNA™ test is generated.~   "
83591|NCT01963234|"~     Implementing a mobile-phone based system for drug use disorders in primary care settings.~   "
83592|NCT01963221|"~     The purpose of this study is to determine the relationship between thoracic aortic~     inflammation and arterial stiffness in elderly patients.~      Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial~     walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested~     to exert pro-inflammatory actions threw several biological mediators enhancing arterial~     stiffness. Both effects of aging and hypertension are associated with higher levels of~     arterial stiffness, but their respective role is not well established in the pathophysiology~     of arterial stiffening.~      Few data are available neither on the real anatomic aortic impact of aging and hypertension~     on aortic compliance and ventricular function and its relationship to arterial stiffness~     assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase~     contrast magnetic resonance imaging arterial stiffness measurements.~      Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose~     (FDG) has been advocated as a means of measuring arterial wall inflammation in various~     population referred for oncology staging. FDG uptake is correlated with the number of~     cardiovascular risk factors and even the risk of future cardiovascular events. This method,~     combined with X-ray computed tomography (CT), has also demonstrated that aortic~     calcifications quantified by CT and local signs of inflammation detected by FDG uptake~     contribute to arterial stiffness. A strong relationship between large vessels stiffening~     assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications~     quantified by CT and inflammation evaluated by FDG uptake has been demonstrated.~      Therefore, in the current study, we use FDG PET associated to CT to characterize aortic~     inflammation and aortic calcifications coupled to pulse wave velocity measurement and~     cardiac function in elderly individuals.~      In fact, if vascular aging promoting a local inflammatory process is a risk factor for~     cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging~     (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty~     individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse~     wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast~     magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid~     calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio),~     predictors of cardiovascular mortality were also quantified. Thoracic aorta local~     inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission~     tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation~     (high-sensitivity C-reactive protein, interleukin 6 were also determined).~   "
83593|NCT01963208|"~     The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -~     on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic~     medications (AEDs).~   "
83594|NCT01963195|"~     The purpose of this study is to evaluate the efficacy and safety of dose escalation of~     Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of~     Icotinib, Iressa and Tarceva.~   "
83595|NCT01963182|"~     This prospective, non randomized multicenter phase II study, will determine the feasibility~     of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with~     metastatic colorectal cancer treated with FOLFIRI.~   "
83596|NCT01963169|"~     Bone health is a significant public health issue in the United States. An estimated 10~     million Americans age 50 and older are living with osteoporosis, and approximately 50% of~     women and 25% of men over age 50 will experience an osteoporosis-related fracture in their~     remaining lifetime. Recent research advancements have produced effective measures to improve~     and maintain bone health, including exercise, diet, screening tests, pharmacotherapies, and~     fall prevention strategies. These findings, however, have not been fully incorporated into~     the daily lives of adults, and many are unaware of the magnitude of bone-health problems.~     Thus, greater efforts must be made to effectively disseminate evidence-based research~     findings to improve bone health behaviors of the public. The Internet, with its increasing~     popularity, can be an effective tool in this endeavor. Despite a great deal of available~     online health resources, there has been a lack of research investigating effective methods~     to package and deliver these resources to yield positive public health outcomes. Expanding~     upon our prior findings and using an innovative approach combining two models of the social~     cognitive theory (SCT) and the RE-AIM framework (Reach, Effectiveness, Adoption,~     Implementation, Maintenance), in this proposal, we propose a large scale online study (N =~     866) that will compare the long-term impact of two SCT-based online bone health~     interventions in adults age 50 and older targeting two large online communities. The two~     interventions are (1) an 8-week SCT-based Online Bone Health (TO-BoneHealth) program and (2)~     a 12-month TO-BoneHealth Plus program, including the TO-BoneHealth program followed by~     biweekly theory-based eNewsletters with follow-up of each individual's bone health behaviors~     (booster intervention) for 10 months. The interventions' impact will be assessed on the~     following the modified RE-AIM framework: (a) Effectiveness (knowledge, selected bone health~     behaviors, fall incidence, initiation of a discussion about bone health with a primary care~     provider, eHealth literacy); (b) Reach (number of participants the program reached); (c)~     Implementation (program usage); and (d) Maintenance (participants' bone health behavior~     maintenance). With the rapid growth of online communities, findings from this study will~     significantly contribute to current eHealth practice and research and serve as a~     dissemination model for other health promotion projects targeting online communities.~   "
83597|NCT01963156|"~     The aim of this study is to evaluate if synchronizing when patients with diabetes and/or~     coronary artery disease fill their prescriptions improves long-term adherence to these~     medications.~   "
83598|NCT01963143|"~     The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous~     immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a~     28-day dosing interval (AUC0-28) in a cohort of adult subjects.~      The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and~     Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval~     (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and~     Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the~     safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to~     assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to~     investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.~   "
83599|NCT01963130|"~     This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects~     portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.~   "
83600|NCT01963117|"~     The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is~     chemotherapy, but considerable portion of the patients progressed and most of the liver is~     converted to metastatic tumor lesions. Significant quality of life decrement was detected in~     those patients, especially in patients suffered severe symptoms Several studies reported~     that whole liver RT (WLRT) can be used effectively to control severe symptoms from~     unresectable liver metastasis in gastrointestinal tract cancer patients. However, it is well~     known fact that the liver is a very sensitive to RT. Despite symptom palliation is obtained~     after 20 to 30 Gy RT but only in small subset of patients get local control. In this aspect,~     the combined with radiosensitizer with WLRT is considered to enhance RT effect to palliate~     symptom and control local tumor progression, and increase the quality of life ultimately.~      It is reported that hyperthermia is considered as the most valuable radiosensitizer in~     cancer treatment, theoretically. Based on those studies, we start this prospective study to~     investigate the effect of combination treatment of WLRT and hyperthermia on quality of life~     in the patients with unresectable chemoresistant liver metastasis from gastrointestinal~     tract cancer.~   "
83601|NCT01963104|"~     The overall goal of the project is to evaluate innovative, cost-effective, community-based~     automated hearing screening and education methods to motivate individuals with~     mild-to-moderate hearing loss to enter the hearing healthcare system.~   "
83625|NCT01962792|"~     Phase 1 will be an open-label study. The dose escalation portion of the study is designed to~     establish the MTD of ibrutinib in combination with carfilzomib with or without~     dexamethasone.~      Phase 2b will be an open-label, multicenter study designed to evaluate the overall response~     rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.~   "
83602|NCT01963091|"~     Stress is associated with drug craving and relapse in substance-dependent individuals.~     Hormones released from the brain may mediate the behavioral response to stress. For example,~     several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.~     Specifically, it appears that oxytocin promotes trust, social interaction, and calmness;~     yet, little is known about the potential affects of oxytocin in cocaine-dependent~     individuals. Given these properties of oxytocin, it may have a therapeutic role in~     ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent~     individuals, as well as the anxiety associated with withdrawal. This pilot protocol will~     provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent~     individuals.~   "
83603|NCT01963078|"~     The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in~     men and women with and without PTSD who have experienced childhood trauma. The study will~     also compare the effects of oxytocin and placebo on amygdala response, and explore the~     interaction of oxytocin plasma levels and amygdala response in men and women with and~     without PTSD who have experienced childhood trauma.~      Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to~     resilient subjects, and no sex differences in the magnitude of the response will be found.~      Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala~     responding than men.~      Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in~     amygdala responding compared to women without PTSD.~      Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with~     PTSD, and women and men without PTSD.~      Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to~     fearful faces in women but not in men.~   "
83604|NCT01963065|"~     The purpose of this study is to evaluate whether babies are exposed to significant levels of~     chemicals during their stay in the neonatal intensive care unit (NICU). For example, other~     research studies have shown that babies are exposed to plasticizers (bisphenol A,~     phthalates) in the NICU. Plasticizers are chemicals that are used to make plastic medical~     equipment soft and flexible. The research team wants to find out whether the amount of~     plasticizer and other chemicals babies may be exposed to in the NICU makes a difference in~     how they grow and how they perform on neurologic tests.~   "
83605|NCT01963052|"~     The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and~     anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at~     least one prior chemotherapy regimen for metastatic disease.~   "
83606|NCT01963039|"~     Background The standard care in patients with a painful osteoporotic vertebral compression~     fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally~     invasive technique, is a relatively new treatment option. Recent randomized controlled~     trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of~     PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at~     acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses~     on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found~     that half of patients still had disabling pain after 3 months or longer. These patients with~     sustained pain after 3 months may benefit from PV.~      Objective To compare pain relief after PV with a sham intervention in selected patients with~     a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion~     criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability~     and quality of life.~      Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint.~     Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture~     level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS)~     score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age~     50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed.~     Follow-up is at regular intervals during one year period with VAS score for pain as primary~     endpoint. Secondary endpoints are back pain related disability and quality of life measured~     with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and~     physical function measured with the Roland Morris Disability questionnaire.~      Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of~     vertebroplasty in patients with sustained pain 3 months or longer after a vertebral~     compression fracture.~   "
83607|NCT01963026|"~     Introduction In recent years, client-centred and task-oriented training have emerged as~     important methods in rehabilitation including the rehabilitation of persons with spinal cord~     injury (SCI). The task-oriented intervention focuses on resolving, reducing and preventing~     impairment, developing effective task-specific strategies and adapting functional~     goal-oriented strategies to changing environmental conditions. Currently, task-specific~     training is mainly achieved by constant practice (i.e. repeating the task without variation)~     and is reported to improve performance of the trained task, but to have a negative impact on~     untrained tasks. Practice variability, however, is reported being advantageous to transfer~     training results into daily live. This paradox poses challenges in clinical practice, where~     task-specific training is essential to deliver client-centred training in order to focus on~     the patients' specific individual goals, but practice variability is important to be able to~     transfer the learned task into daily practice. Questions regarding the effective elements~     within rehabilitative interventions and the exact mechanisms behind the cerebral changes~     they may induce, remain. These questions require further research, for which ultra-high~     field fMRI techniques will be used. Furthermore, compensation of muscle function loss (i.e.~     the development of new muscle synergies) plays an important role in the improvement of skill~     performance in cervical SCI. Surface EMG allows to study the changes in muscle coordination,~     parallel to the changes at cerebral level.~      Aims This study aims to~        1. investigate which basic neural mechanisms of motor learning underlie functional~          recovery of arm hand skilled performance during client-centred task-oriented training~          of the upper limb in patients with cervical spinal cord injury and~        2. investigate the contribution of 'practice variability' in contrast to 'constant~          practice' on arm-hand skilled performance, motor control and neural changes.~      Study design This study features a multiple single-case experimental design (A-B-C design)~     with baseline (phase A) (6 weeks), intervention B (phase B) (3 weeks) and intervention C~     (phase C) (3 weeks). Intervention B will contain the 'practice variability' component.~     Intervention C will feature the 'constant practice' component. The order of phase B and C~     will be randomly assigned to participants. Four measurements during baseline and after each~     intervention phase (B and C) will be performed, thus producing a time series, per measure,~     for each patient. Also, meta-analyses on the pooled single-case data will be performed.~      Setting/population Six patients with a cervical SCI (complete and incomplete) will be~     recruited from the Spinal cord unit of Adelante Rehabilitation Centre in the (sub)acute~     phase.~      Intervention After therapy as usual (intervention A), the Task-oriented Client-centred Upper~     Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be provided. In this~     program individual goals will be extracted using the Canadian Occupational Performance~     Measure(COPM) and the training program is based on a task-analysis and uses principles of~     training physiology and motor learning. Intervention B will consist of the ToCUEST program,~     including the component 'practice variability' (ToCUEST variability). Intervention C will~     consist of a modified ToCUEST program in which the component 'practice variability' will be~     replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of~     these components. Intervention A' will be therapy as usual.~      Measurements Measurements will be taken at the level of activities (arm hand skilled~     performance, i.e. Van Lieshout Test, Spinal Cord Independence Measure, Goal Attainment~     Scale) and body function (Upper Extremity Motor Score, Graded Redefined Assessment of~     Strength Sensibility and Prehension Test, Surface EMG), and at cerebral level, i.e. neural~     activity changes (by means of ultra-high field fMRI).~      The fMRI measurements will be taken before and after each intervention B and C in 4 patients~     (2 with complete and 2 with incomplete lesion).~      Data-analyses Baseline data stability and any baseline trends regarding the outcome measures~     at body function level and activity level will be assessed. To control for, e.g.,~     spontaneous recovery effects, baseline data (phase A) will be used in a computer-based~     detrending model. For the meta-analyses, mean data per outcome measure, per phase, per~     subject will be pooled and subsequently analysed using non-parametric statistics, i.e.~     Friedman analyses and Wilcoxon tests.~   "
83608|NCT01963013|"~     This study was to determine efficacy of the non-returning catheter valve for reducing~     catheter associated urinary tract infection compared with conventional urine bag in~     critically ill patients.~   "
83609|NCT01963000|"~     Community acquired pneumonia (CAP) is associated with a high in-hospital mortality.~     Standardization of diagnostics and adherence to sepsis bundles in the emergency department~     (ED) are associated with reduced mortality in patients with sepsis. Investigators examined~     whether the introduction of standardized care bundles and check lists in the ED are~     associated with a reduced mortality rate in patients hospitalized for CAP.~      This is an observational trial. The investigators retrospectively analyzed performance~     indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital,~     Germany, from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took~     place including interprofessional education, checklists and institutionalized feedback.~     Primary endpoint was in-hospital mortality of CAP patients. After the implementation of CAP~     care bundles in the ED, mortality of affected patients was significantly lower in 2009~     compared to 2008. This study should demonstrate that the implementation of a standardized~     CAP care bundle in the ED is associated with a risk reduction in affected patients.~     Standardization of diagnostic and therapeutic processes in the ED therefore improves the~     outcome of patients hospitalized for CAP.~   "
83610|NCT01962987|"~     To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3%~     (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)~     in the treatment of the actinic keratosis~   "
83611|NCT01962974|"~     This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects~     with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease~     control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in~     28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα~     therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg~     every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.~      To be eligible for participation, subjects must have previously demonstrated initial and/or~     temporary improvement in disease signs and symptoms, who have since exhibited a diminished~     response despite continued treatment. It is estimated that 200 subjects will be enrolled in~     the study at approximately 85 global sites.~   "
83612|NCT01962961|"~     The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces~     oxidative stress and improves vascular function in HIV-infected older adults already on HIV~     treatment.~   "
83613|NCT01962948|"~     This phase I/II trial studies the side effects and best dose of ganetespib when given~     together with paclitaxel and to see how well they work in treating patients with recurrent~     ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be~     an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.~   "
83614|NCT01962935|"~     Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or~     with AZD 5069~   "
83615|NCT01962922|"~     Open label, prospective, single-center, randomized, two sequence, three period crossover~     study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus~     capsules administered twice daily in stable African-American renal transplant patients.~   "
83616|NCT01962909|"~     The purpose of this clinical trial is to study an experimental drug called PTP-01 that is~     being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer~     is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early~     stage disease. Researchers at the University of Virginia have identified a biomarker for~     pancreatic cancer called plectin, which is very specific for pancreatic cancer and not~     other, non-cancerous conditions involving the pancreas. These researchers have also~     developed PTP-01, an experimental drug that may be used with SPECT imaging to detect~     pancreatic cancer cells in humans.~   "
83617|NCT01962896|"~     The purpose of this study is to find out if the combination of an mTOR inhibitor (sirolimus)~     with an EGFR inhibitor (erlotinib) is effective at treating relapsed or refractory germ cell~     tumors, and to find out what the side-effects of this regimen are.~   "
83618|NCT01962883|"~     The proposed study is a randomized clinical trial with the purpose of determining the~     efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular~     disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance~     Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic~     assessment findings of this population and side effects, positive and negative, associated~     with the osteopathic treatment provided.~      Primary Hypothesis~        1. Osteopathic treatment will have no effect on the symptoms of dizziness of the~          vestibular disturbed post concussed athlete using the Dizziness Handicap Inventory~        2. Osteopathic treatment will have no effect on the balance recovery of the vestibular~          disturbed post concussed athlete using Balance Error Scoring System (BESS)~           Secondary Hypothesis~        3. To determine the side effects of osteopathic treatment of the vestibular disturbed post~          concussed athlete~   "
83619|NCT01962870|"~     Researchers at the Stanford University School of Medicine are seeking participants for a~     study examining the effectiveness of vasopressin, a neuropeptide, in treating children with~     autism spectrum disorder. Difficulty with social interactions is characteristic of people~     with autism, who often have problems interpreting facial expressions or maintaining eye~     contact while talking with someone. There are currently no effective medicines available to~     treat social problems in individuals with autism. Neuropeptides, such as vasopressin and~     oxytocin, are molecules used by neurons in the brain to communicate with one another.~     Vasopressin is closely related to oxytocin, which is currently being tested as a treatment~     for autism, and has been shown to enhance social functioning in animals. Animal studies have~     shown that when the proper functioning of vasopressin is experimentally altered, animals~     develop a variety of social deficits, including impaired memory for peers and a reduced~     interest in social interaction. Researchers found that when vasopressin was administered to~     mice with a genetically induced form of autism, their social functioning improved.~     Vasopressin is already approved by the Food and Drug Administration for use in humans, and~     has proved to be a successful treatment for some common pediatric conditions, including~     bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and~     memory in people who do not have autism. The researchers will test the effects of~     vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old.~     The study will last four weeks for each participant. Participants will receive either~     vasopressin or a placebo nasal spray. At the end of this phase of the study, those who~     received the placebo will have the option of participating in a four-week trial during which~     they will be given vasopressin. Stanford is the only site for the study. Participants do not~     need to live locally but will need to come to the Stanford University Department of~     Psychiatry and Behavioral Sciences for study visits.~   "
83620|NCT01962857|"~     A number of studies have shown that short duration, high intensity interval training can~     improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness.~     However, these often use specialized equipment, such as cycle ergometers, which makes it~     difficult to roll these interventions out for wide-scale use in the general population. This~     study aims evaluate the effects of a high intensity shuttle running intervention on insulin~     sensitivity, fitness and related cardiometabolic risk factors in men who are currently~     inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and~     control groups. We hypothesize that the shuttle running programme will result in improved~     insulin sensitivity, fitness and increased fat oxidation at rest compared with the control~     group.~   "
83621|NCT01962844|"~     The purpose of this study is to evaluate the supplementation with extra virgin of coconut~     oil combined with a nutritional counseling in reducing anthropometry and improves the lipid~     profile in patients with chronic coronary disease.~   "
83622|NCT01962831|"~     The purpose of this study is to compare the efficacy of single balloon foley catheters to~     dinoprostone for the induction of labour of obese women. The investigators suspect that~     women assigned to the foley group will have a shorter induction to delivery time than women~     in the dinoprostone group.~   "
83623|NCT01962818|"~     Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High~     frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal~     pressure fluctuation around a continuous distending pressure and therefore small tidal~     volume. Animal studies showed that recruitment and maintenance of functional residual~     capacity (FRC) during HFOV (open lung concept) could reduce lung injury.~      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using~     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with~     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at~     a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable~     oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung~     recruitment.~      Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation~     distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of~     the subject based on measurement of surface electrical potentials resulting from an~     excitation with small electrical currents and has been shown to be a valid and safe tool in~     neonates.~      Purpose, aims:~        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in global~          and regional EELV (primary endpoints) and spatial distribution of ventilation measured~          by EIT~        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist~          planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that~          regional ventilation distribution is more homogenous.~      Methods:~      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will~     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4~     alternating 1-hours periods (2-treatment, double crossover design, each patient being its~     own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise~     HFOV will remain at pretrial settings.~      16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each~     recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each~     change in ventilator modus.~      Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is~     a pilot-trial.~      In a similar study-protocol of lung recruitment during HFOV-sigh using a/A-ratio as~     outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This~     assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the~     present study examines the same intervention we assume that N=16 patients will be a~     sufficient sample size. We estimate to include this number in 6 months.~   "
83624|NCT01962805|"~     This study is a double-blind crossover study in female healthy volunteers to compare the~     pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations~     of Proellex for vaginal administration. Each formulation will be designated as either~     Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be~     randomized to receive either Treatment A or Treatment B as their first assigned treatment.~     Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6~     days. After a 7-day washout period subjects will receive the alternative treatment. On the~     day of treatment with Treatment A and on the first and last days of treatment with Treatment~     B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic~     assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours~     after administration of study drug. For Treatment B study drug will be administered in the~     clinic each day after a trough blood sample has been drawn.~   "
83848|NCT01959867|"~     This is a prospective clinical study comparing two-stage breast reconstruction following~     mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in~     patients with pre-mastectomy radiation therapy.~   "
83626|NCT01962779|"~     Our preliminary data show for in cognitively-normal elderly, that Sleep Disordered Breathing~     (SDB) is associated with the increase of cerebrospinal fluid (CSF) phosphorylated-Tau~     (P-Tau) and total-Tau (T-Tau), decreases in medial temporal lobe glucose uptake (FDG-PET)~     and volume (MRI) and progressive memory decline, all of which have been shown to be useful~     in predicting future dementia in older adults. These findings raise the question as to~     whether Alzheimer's disease (AD) tissue damage causes SDB in the elderly, or alternatively,~     if SDB acts as a risk factor for AD neurodegeneration. In the proposed study, we will~     investigate these mechanistic hypotheses in cognitively normal elderly by examining the~     longitudinal associations between SDB and cognitive decline, novel MR neuroimaging and CSF~     biomarkers for neurodegeneration; while our secondary goal is to launch a pilot treatment~     study to aid in interpreting the mechanistic hypotheses and to examine the effects of nasal~     continuous positive airway pressure (CPAP) on cognitive decline and neurodegeneration.~   "
83627|NCT01962766|"~     The current research project aims to study the efficacy of myofunctional therapy and its~     orthodontic long-term outcomes.~   "
83628|NCT01962753|"~     The primary objective of the study is to compare the brain amyloid load in fully, partially~     and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using~     PET with [F18]AV45.~   "
83629|NCT01962740|"~     The study is proposed as a 48-patient randomized-controlled pilot study that will use~     Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition~     of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa~     Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES~     (Boston Scientific, Natick, MA)] at 6 weeks post implantation.~      Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience~     EES, Promus EES and will be similar to each other and improved (higher rates of stent strut~     coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks~     post-implantation.~   "
83630|NCT01962727|"~     Study Design: Clinical measurement (cross-sectional)~      Objectives: The purpose of this study was to investigate the reliability and validity of the~     novel scapular dyskinesis classification test.~      Background: A visual-based clinical assessment with sufficient reliability and validity to~     identify scapular dyskinesis provides information for rehabilitation treatment.~      Methods: A visual-based palpation method was evaluated by two independent physiotherapists~     in 60 subjects with unilateral shoulder pain to test reliability. This method classified the~     scapular movements during arm raising/lowing movements in scapular plane as single abnormal~     scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and~     abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of~     scapular dyskinesis were also validated by corresponding alternation of the scapular~     kinematics and muscular activities assessed by electromagnetic motion-capturing system and~     surface electromyography (EMG).~   "
83631|NCT01962714|"~     This randomized controlled trial will assess whether a novel complementary and alternative~     medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior~     to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only~     version; CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans~     with current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that~     Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom~     severity that are not meaningfully worse than CPT-C. The investigators further hypothesize~     that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and~     depressive symptom improvement for those assigned to CPT-C than those assigned to LKM.~   "
83632|NCT01962701|"~     The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is~     studied.~   "
83633|NCT01962688|"~     The purpose of this study is to see if using a portable handheld ultrasound to guide~     diuretic therapy for heart failure patients will prevent hospital readmissions. This study~     will use a handheld ultrasound called a Vscan to look at a large vessel in the body called~     the Inferior Vena Cava (a vein leading to your heart) . The study aims to see whether~     changing diuretic therapy based on the size of this vessel will result in the less~     hospitalizations for heart failure patients as compared to just symptom guided therapy. This~     study is composed of two independent non-interacting trials—one in the outpatient setting~     and one in the inpatient setting.~   "
83634|NCT01962675|"~     The study investigates the effect of using transcranial direct current stimulation (tDCS)~     and skilled stepping training versus skilled stepping training with sham-tDCS in improving~     ankle and leg motor control in persons with ambulatory persons with spinal cord injury.~      Hypotheses H1: Participants will display greater improvement in stepping function following~     tDCS combined with training compared to sham-tDCS and training.~      H2: Participants will display greater gains in cortical excitability, as evidenced by lower~     cortico-motor threshold (MT) associated with the TA muscles following tDCS and training~     compared to following sham stimulation and training.~      H3: Participants in the tDCS+training group will show greater increases walking speed in a~     timed 10 meter walking trial.~      H4: Participants in the tDCS+training group will show be able to perform a greater number of~     toe-taps test.~   "
83648|NCT01962480|"~     Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh~     reinforcement has gained increasing acceptance among surgeons despite creating a~     tension-based repair. Beneficial effects of this technique have sporadically been reported~     but no evidence is available from randomized controlled trials.~      The primary purpose is to compare early postoperative activity-related pain in patients~     undergoing ventral hernia repair with closure of the gap with patients undergoing standard~     laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis~     and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence~     and chronic pain after 2 years.~      Material and Methods: A randomized, controlled, double-blinded study is planned. Based on~     power calculation we will include 40 patients in each arm. Patients undergoing elective~     laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre~     Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to~     participate.~      Conclusion: The technique with closure of the gap may induce more postoperative pain, but~     may be superior with regard to other important surgical outcomes. No studies have previously~     investigated closure of the gap in the setting of a randomised controlled trial.~   "
83635|NCT01962662|"~     Force generation and force level control are important neuromuscular control mechanism for~     successful execution of movement for our daily activities. Impaired force level control is a~     major deficit of motor control in people with stroke. Electromyographic biofeedback (EMG~     biofeedback) has been suggested by researchers and clinicians to be a useful and effective~     tool for enhancing control of force level during motor skill learning for people with~     stroke. Based on the concept of motor-skill learning, practice with variable force levels~     may be more effective than practice with a constant force level to enhance movement~     performance. The EMG biofeedback provides a suitable tool for such practice of force level~     control and hence for motor skill learning. However, research literatures thus far have yet~     to provide convincing evidences to support this claim. Neural imaging studies have shown~     corresponding brain reorganization and neural plasticity following physical practice of~     movement skills in people with stroke. It is curious whether EMG biofeedback augmented~     physical practice of motor skills enhances brain reorganization. Using brain mapping~     techniques, in particular, the transcranial magnetic stimulation (TMS), we could investigate~     neural plasticity accompanying motor function changes induced by physical training, and~     hence may help to develop safer and more effective training parameters. The purpose of this~     study is to examine the effects of variable practiced EMG biofeedback training emphasized on~     force level control of the ankle muscle on balance and gait performance and the~     corresponding changes of corticospinal excitability using TMS in people with chronic stroke.~   "
83636|NCT01962636|"~     This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using~     a myeloablative preparative regimen for the treatment of hematological diseases, including,~     but not limited to acute leukemias. The myeloablative preparative regimen will consist of~     cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).~   "
83637|NCT01962623|"~     The purpose of this study is to determine the feasibility and acceptability of utilizing an~     adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for~     Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood~     dysregulation disorder (DMDD).~      The investigators hypothesize that retention rates will be >80%, satisfaction scores will~     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT~     intervention will have overall improvement in SMD/DMDD symptoms.~   "
83638|NCT01962610|"~     The goals of this exploratory study are to determine the feasibility of integrating~     electronic clinical decision support into routine clinical pain care for adults in the ED~     setting and gather data on whether or not such clinical decision support is effective in~     improving pain care outcomes in the ED. The use of an electronic pain care alert (ePCA)~     prompting doctors to provide acute pain care for adult patients with complaints of severe~     abdominal pain will be compared to patients seen by clinicians with routine ED care.~      Hypothesis: The ePCA will improve the quality of acute pain care for patients.~   "
83639|NCT01962597|"~     Study Hypothesis: The combination of aerobic and resistance exercise training will improve~     walking speed compared to either individual intervention.~      Brief Summary:~      Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized~     to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a~     bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The~     primary outcome is walking speed over 4-metres. Secondary outcomes will include:~      (i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L];~     (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL)~     index; (v) Leg strength; (vi) body composition and anthropometry.~   "
83640|NCT01962584|"~     To evaluate the additive values of T1 mapping in patients with acute myocarditis.~   "
83641|NCT01962571|"~     This clinical trial aims at preventing visual dysfunction and optic nerve degeneration~     associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU~     erythropoietin over 3 days. The primary objective is to determine the efficacy of~     erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by~     measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months~     after acute optic neuritis.~   "
83642|NCT01962558|"~     Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized,~     controlled, parallel study design.~   "
83643|NCT01962545|"~     The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC)~     monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial~     fibrillation (AF) and prior (>12 months) coronary stenting.~   "
83644|NCT01962532|"~     The purpose of this study is to determine a dose for future development and to evaluate the~     safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in~     Japanese and other Asian patients with advanced or refractory solid tumors or lymphoma.~   "
83645|NCT01962519|"~     The aim of this study is to evaluate the possibility of shortening postoperative hospital~     stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol~     (ERAS).~   "
83646|NCT01962506|"~     Rapid and reliable exclusion of acute myocardial infarction (AMI) during an emergency~     department (ED) triage is a major unmet clinical need. We aimed at verifying the~     non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual~     hs-cTn sampling for the early diagnosis of Non-ST-Elevation Acute Coronary Syndromes~     (NSTE-ACS) versus Non Coronary Chest Pain (NCCP) in a selected cohort of consecutive~     patients admitted at the Emergency Department.~   "
83647|NCT01962493|"~     The aim of this study is to compare the stain effect on teeth of twice daily brushing with a~     67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing~     sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.~   "
83663|NCT01962285|"~     Loss and recovery of consciousness during propofol anesthesia seem to be mediated by~     different mechanisms beyond the actual effect-site concentration of anesthetic drug. This~     eventual difference between dose response curves for loss of consciousness (LOC) and for~     recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia.~     We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate,~     stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state~     conditions between plasma an effect-site concentration, there is still going to exist a~     difference between LOC and ROC, demonstrating the existence of neuronal inertia.~   "
83649|NCT01962467|"~     This is an open label, randomized, 3-way cross-over, and repeat administration study in~     healthy male and female subjects. The purpose of the study is to determine the relative~     bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is~     administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A~     (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18~     subjects will be enrolled). Each part will consist of three treatment periods separated by a~     minimum washout period of 14 days. In each treatment period, subjects will receive seven~     daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray~     according to one of the 6 possible randomization sequences. The study will use an adaptive~     design with an interim review following Part A to confirm whether Part B is required.~   "
83650|NCT01962454|"~     This is a single-blind, randomized placebo-controlled, parallel study, where the study~     volunteers will be blinded to testosterone/placebo treatment. This study will test a~     relatively new, less invasive method for collecting muscle tissue to determine if this~     method is appropriate for collecting muscle samples for the assessment of the fractional~     synthetic rates (FSR) of muscle-derived proteins. This study will also investigate whether~     the FSR of proteins may serve as early biomarkers for muscle anabolism, a known anabolic~     agent (testosterone) will be administered to healthy, elderly male subjects over a 3 week~     period. The fractional synthetic rate of several muscle-derived proteins will be analyzed at~     Baseline and during the period of testosterone treatment using deuterium labelling of these~     proteins by the incorporation of deuterium from deuterated water (D2O).~   "
83651|NCT01962441|"~     This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of~     sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a~     (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3~     hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and~     chronic genotype 2 HCV infection.~   "
83652|NCT01962428|"~     It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus~     conventional loading dose(180mg) will result in a higher inhibition of platelet~     aggregation(IPA) without increasing the bleeding events.~   "
83653|NCT01962415|"~     The objective of this study is to demonstrate the efficacy of using a reduced-intensity~     condition regimen with UCBT, double cord UCBT, matched unrelated donor (MUD) bone marrow~     transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with~     non-malignant disorders that are amenable to treatment with HSCT. After transplant, subjects~     will be followed for late effects and for ongoing graft success.~   "
83654|NCT01962402|"~     The purpose of this study is to determine whether lorcaserin is effective for weight~     reduction in patients with weight gain as a result of antipsychotic medications.~   "
83655|NCT01962389|"~     The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for~     the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)~   "
83656|NCT01962376|"~     The investigators assessed whether the addition of a preoperative regimen of Bevacizumab~     regimen to improves R0 resection rate and survival among patients with potentially~     resectable gastric cancer with liver metastasis.~   "
83657|NCT01962363|"~     The purpose of this study is to evaluate the effects of EPI-743 in patients with~     Friedreich's Ataxia point mutations~   "
83658|NCT01962350|"~     The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers~     are partially effective in the treatment of depressive phase of the illness, although there~     are some reports relating to the antidepressant properties of these drugs. Other~     conventional methods (pharmacological) and non- conventional treatment are not effective or~     involve risks and side effects. Several studies with Transcranial Magnetic Stimulation (TMS)~     showed that magnetic stimulation daily over the left prefrontal cortex may improve the mood~     of patients. TMS is a noninvasive method of stimulating the brain. The instrument used~     nowadays in local research and application Clinical is a metallic coil formed in figure 8~     (coil format 8). This instrument was capable of stimulating only surface areas of the brain,~     primarily the cerebral cortex, at depths of up to 3 inches below the scalp. From this angle,~     there is clearly a need for a means of producing magnetic fields which can reach deeper~     brain areas, such as those involved in mood disorders. TMS has little, if any effect in~     these brain areas. To this end, new coils, calls H, that promote the stimulation of deep~     brain areas were developed in collaboration with the National Institute of Health (NIH) in~     the USA. This new coil - H1 that will be evaluated in this study has been tested for safety~     in NIH in 2003 by Dr. Abraham Zangen. Yet there are very few prospective clinical,~     randomized and controlled trials, on the effects of early and late in clinical-cognitive~     condition and safety of TMS with H1 coils in treating episodes of bipolar depression. The~     application of EMT with H1 coils can reach deepest regions of the brain and improve the~     clinical and cognitive condition of subjects with episodes of bipolar depression, and may be~     confirmed as a safe and virtually free of side effects. By an absence of treatment actually~     effective for bipolar depression, this study will show whether there are clinical and~     cognitive benefits of deep TMS with H1 coil in patients with bipolar depression.~   "
83659|NCT01962337|"~     This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to~     assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in~     adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).~   "
83660|NCT01962324|"~     A single arm phase 2 study to study the outcome of dose-escalation with simultaneous~     integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients~     with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be~     included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is~     that we will have fewer relapses in this very high risk patient group compared to matched~     historical controls with acceptable side effects.~   "
83661|NCT01962311|"~     This project is expected to answer the question of interest assays of metabolites in the CSF~     as a tool for early diagnosis and should show whether it is possible or not to use such~     markers in the blood or urine. These studies should also help shed light on the~     pathophysiological original early clinical disease. While ALS appears to be more a clinical~     syndrome that pathophysiological entity unique metabolic abnormalities identified could help~     identify mechanisms disrupted in which therapeutic interventions will be possible.~   "
83662|NCT01962298|"~     The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle~     activity is well known. However, since the availability of sugammadex, to our knowledge, no~     study has been conducted to evaluate the effect of this novel product on these muscles.~      Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking~     agents and their reversal agents we might see a different activity of the respiratory~     muscles.~   "
83849|NCT01959854|"~     The purpose of this study is to evaluate the effect of an ophthalmic solution containing~     0.2% xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of~     oxidative stress.~   "
83665|NCT01962259|"~     The aim of present randomized controlled trial is to evaluate the health effects of physical~     activity in transport and leisure time domains of everyday life and to develop durable~     physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle~     routine, in overweight individuals.~      Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical~     activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4:~     a non-intervention control group~   "
83666|NCT01962246|"~     Stage I：preoperative therapy~        -  Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone~          ; Stage II: Perioperative therapy~        -  Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to~          adjuvant Capecitabine plus oxaliplatin alone;~        -  A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with~          incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal~          cancer . The investigators assessed whether the addition of a perioperative regimen of~          XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate~          and survival among patients with curable locally advanced adenocarcinoma of stomach and~          gastroesophageal cancer~   "
83667|NCT01962233|"~     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem~     Cells transplantation in hypoxic ischemic encephalopathy.~   "
83668|NCT01962220|"~     Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT)~     services and keeping them in care is important in ensuring that both mother and infant~     beneﬁt from interventions that improve maternal health and decrease HIV transmission to~     infants. We propose an evaluation of strategies to link newly diagnosed HIV-infected women~     to care and keep them in care during pregnancy and after delivery in our study called~     MIR4HEALTH. The study will be conducted in Nyanza Province, Kenya. All participants will~     provide informed consent and will be randomized to receive the intervention, including~     individualized patient education, adherence support and phone call/Short Message Service~     (SMS) reminders for clinic appointments, or the standard of care (no additional intervention~     services).~   "
83669|NCT01962207|"~     The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and~     10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT~     versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of~     MenACWY-TT administered 10 years after the primary vaccination. All subjects received a~     primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects~     will be enrolled in this booster study.~   "
83670|NCT01962194|"~     The investigators hypothesize that the emotional and cognitive areas of the Subthalamic~     Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of~     these areas can influence the mental and the emotional state. Parkinson's disease (PD; n=5)~     and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with~     Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) will be recruited over a period of~     two years. The patients will be enrolled in a prospective, open label, clinical trial and~     will be followed for one year. No randomization or blinding will be used in this study.~   "
83671|NCT01962181|"~     In this study we try to identify the signature of brain activity in the EEG of attention~     deficit disorder (ADHD) patients compared to healthy subjects under different doses of~     Ritalin (methylphenidate) treatment.~   "
83672|NCT01962168|"~     The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially~     available device to gather physician experience with the Cook Evolution® Biliary Stent~     System for the palliation of cancer in the biliary tree. Patients will be treated as per~     usual medical practices.~   "
83673|NCT01962155|"~     The aim of our prospective study is to construct and validate a non-invasive model~     consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver~     fibrosis caused by hepatitis B virus in mainland China.~   "
83674|NCT01962142|"~     Limitation of activity is one of the main item used by composites scores designed to assess~     the level of asthma control. Since this item is systematically subjectively assessed by the~     patient, the investigators would like to know if these subjective data are correlated with~     objective data.~      Aims of this study are: 1) To describe what means limitation of activity for asthma~     patients and how they deal with; 2) To describe the objective exercise capacity and~     characteristics of daily activity in two situations (on exacerbation, out of an~     exacerbation).~   "
83675|NCT01962129|"~     The aim of this multicentre study will be to better describe the clinical characteristics~     and the etiological bases of patients with OFD syndrome by identifying new genes involved in~     OFD syndrome. These results will make it possible, from patients who have been clearly~     identified from a clinical, cytogenetic and molecular point of view, to determine a study~     strategy in such patients. The data obtained will be used to guide clinical geneticists in~     genetic counselling for patients and their families.~      Identification of the molecular bases of the different OFD syndromes will make it possible~     to determine whether or not they belong to the group of ciliopathies like type I OFD and to~     understand their physiopathological bases.~      This study will also make it possible to better characterise the phenotype of boys with~     syndromic mental retardation related to the OFD1 gene and thus to define the clinical~     criteria of the study of this gene in boys with mental retardation.~      The complete absence of knowledge concerning the genetic bases of OFD syndromes, apart from~     type I, the presence of a large collection of samples from patients with OFD syndrome at~     Dijon CHU, the recognition of the diagnostic laboratory for syndromic OFD at the~     international level as well as the technical platform and expertise in molecular cytogenetic~     methods including CGH-array and molecular genetics (sequencing, quantitative PCR, fragment~     analysis) at the Cytogenetics and Molecular Biology laboratories at Dijon CHU justify the~     implementation of such a study in 2010.~   "
83735|NCT01961349|"~     This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled,~     phase III confirmatory study. The study will be partially double-blinded: the comparison~     between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried~     out in double-blind, but the comparison between Group 1 (placebo group) and Group 3~     (ICI35,868 with EES0000645/A) will be carried out in single-blind.~      The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be~     moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic~     polypectomy will be evaluated.~   "
83676|NCT01962116|"~     After obtaining written informed consent and inclusion, patients will be randomised into 2~     groups for the type of dialysis catheter lock:~        -  The first group will have a citrate lock~        -  The second group will have a heparin lock Patients will be stratified according to the~          centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.~      The daily surveillance of patients will be no different from the usual surveillance of~     patients on Renal Replacement Therapy.~      The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.~      The decision to withdraw the catheter will be made by the investigator and based on clinical~     criteria (complications related to the catheter, termination of Renal Replacement Therapy…)~   "
83677|NCT01962103|"~     The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid~     tumors, and to see if it works to treat these solid tumors in children and young adults (≤~     21 years old). After the final dose has been chosen, patients will be enrolled according to~     the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see~     how nab-paclitaxel works in treating these tumors.~   "
83678|NCT01962090|"~     This study is designed to compare the short term effects of two different thoracic spine~     thrust manipulation techniques on neck range of motion, pain, and self-reported disability~     in a sample of dental students experiencing neck pain.~      The hypothesis of the study is that there will be a difference between the two thoracic~     spine thrust manipulation techniques for short term effects on neck range of motion, pain,~     and self-reported disability in a sample of dental students experiencing neck pain.~   "
83679|NCT01962077|"~     assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary~     molars with carious pulp exposure in comparison to Formocresol.~   "
83680|NCT01962064|"~     The purpose of this study is to examine the age and the neurodegenerative disease effects on~     social cognition. Secondary goals are to better understand the relationships between~     different component of social cognition, executive functioning, and behavior and describing~     the neuronal substrates associated to the alteration of the social cognition in ageing and~     dementia.~   "
83681|NCT01962051|"~     The ACP device will be clinically evaluated through a prospective, open-label,~     nonrandomized, multi-center post market clinical study.~   "
83682|NCT01962038|"~     The purpose of this study is examine the efficacy of a combination physical exercise and~     cognitive training program on improving memory in older Veterans with amnestic Mild~     Cognitive Impairment.~   "
83683|NCT01962025|"~     The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to~     two different methods of putting needles in their arteriovenous fistula and, 2) if we can~     adequately coordinate all of the sites to get useful multicentre trial data~   "
83684|NCT01962012|"~     The purpose of this study is to examine the amount of tooth movement achieved over time~     between subjects undergoing aligner treatment using a pulsation device known as AcceleDent®~     Aura with those not using the device.~   "
83685|NCT01961999|"~     The question of timing of initiation of renal replacement therapy (RRT), early versus~     late, has seldom been the focus of high-quality or rigorous evaluation. As a consequence,~     initiatives aimed at identifying the optimal timing of initiation of RRT in acute kidney~     injury (AKI) have been given the highest priority for investigation by the Acute Kidney~     Injury Network (AKIN). Accordingly, the investigators conducted a prospective, controlled,~     interventional trial, comparing two treatment groups in which the only variable was the RRT~     initiation strategy, to determine whether early versus late initiation in patients with~     AKI after cardiac surgery is associated with a survival benefit or more favorable outcomes.~   "
83686|NCT01961986|"~     Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder~     replacement (TSR).~      Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder~     replacement (TSR) is performed using the traditional surgical approach (called the~     subscapularis release approach) as compared to patients who have a TSR procedure done using~     a newer surgical approach (called the rotator cuff sparing approach).~   "
83687|NCT01961973|"~     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:~     The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: The participating patients will be divided into two groups, each group~     receiving either one of the treatment modalities. This study will not be randomised or~     blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A~     Shetty, who is one half of the team that devised both techniques. The post-operative~     rehabilitation process will be the same for both groups.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each group~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and~     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm~     scores; cartilage growth will be measured by the MOCART score.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other by~     studying pain relief, cartilage growth and improvement in function.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
83688|NCT01961960|"~     The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374~     in adults ≥61 years of age.~   "
83689|NCT01961947|"~     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture~     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine~     (TIV) in adults ≥20 and <65 years.~   "
83690|NCT01961934|"~     This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly~     identify recurrent tumor versus post treatment effects (radionecrosis) in patients with~     previously treated high grade brain gliomas.~   "
83691|NCT01961921|"~     The purpose of this study is to evaluate the safety and tolerability of long-term dosing~     with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).~   "
83850|NCT01959841|"~     To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with~     valaciclovir (VACV) 3000 mg in patients with herpes zoster.~   "
83692|NCT01961908|"~     This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment~     cycles, each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea,~     non-menstrual pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and~     vaginal bleeding intensity will be recorded using an electronic diary and Visual Analog~     Scale (VAS) pain assessment will be utilized. All subjects will have completed an Off-Drug~     Interval (ODI) prior to starting treatment. Visit 1 will be scheduled within a week before~     the next expected menses (+/- 2 days), following the off-drug interval. Subjects will~     receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will~     be followed until menses has returned. During the follow-up period subjects will continue to~     record study information in the electronic diary. The final follow-up visit will be~     scheduled after blood flow has stopped.~   "
83693|NCT01961895|"~     The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus~     block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery~     for hip fractures, expressed as a reduction of ischemic events per subject.~   "
83694|NCT01961882|"~     To compare disease-free survival in patients 60 years or older with acute myeloid leukemia~     (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.~   "
83695|NCT01961869|"~     This clinical trial studies black raspberry confection in preventing oral cancer in healthy~     volunteers. Black raspberry contains ingredients that may prevent or slow the growth of~     certain cancers.~   "
83696|NCT01961856|"~     In the PLATO substudy referring to patients presenting with an ST-elevation Myocardial~     Infarction(STEMI), out of the 4201 who received ticagrelor, 1326 had been pre-treated with a~     600mg clopidogrel loading dose (LD) within 24 hours prior to randomization. It is a logical~     assumption, that patients who are being reloaded with ticagrelor will demonstrate reduced~     platelet reactivity (PR) at 24 hours, in comparison to those who were initially loaded with~     ticagrelor, due to the synergistic antiplatelet effect. Single loading with ticagrelor~     though, will possibly be accompanied by a smaller bleeding potency compared to reloading~     with ticagrelor. Therefore, we assume that single loading with ticagrelor is non-inferior to~     reloading with ticagrelor, in terms of platelet reactivity.~      P2Y12 inhibitor naive patients with STEMI, they will be randomized immediately after~     coronary angiography (Hour 0) in receiving either Ticagrelor 180mg LD or Clopidogrel 600mg~     LD and 2 hours later reloading with Ticagrelor 180mg, after written informed consent. PR~     will be measured, using the VerifyNow assay at randomization (Hour 0) and at 2, 4, 6 and 24~     hours post randomization. In addition, a 12-lead ECG will be performed before randomization,~     90 and 180 minutes after the first balloon inflation, as well as on the exit day. Troponin I~     and CK-MB will be assessed at randomization and at hour 4, 12, 24, 48 and 72 after~     randomization.~      Non inferiority of Ticagrelor LD versus Ticagrelor re-LD would be accepted if the upper~     bound of the 2-sided 95% CI around the estimated LS mean difference (Ticagrelor LD minus~     Ticagrelor re-LD) in the primary end point (PR at 24 hours) would lie bellow Δ=35 PRU. This~     non-inferiority margin (Δ) represents the upper bound of the LS mean difference in PR~     between Ticagrelor and Prasugrel arm at 24 hours after LD in a pharmacodynamic study of 55~     STEMI patients.~      Considering previous studies PR at 24 hours post randomization was estimated at 47±40 PRU~     and 41±35 PRU for Ticagrelor only LD and Ticagrelor re-LD group respectively. To obtain 85%~     statistical power with a 2-sided alpha=0.05, approximately 32 patients in each treatment~     group (64 in total) would be needed to establish the primary hypothesis using the~     abovementioned non-inferiority margin of 35 PRU. Anticipating a 5% dropout rate, enrollment~     was set to at least 68 patients. The primary endpoint, as well as PR at all the other time~     points of the study will be analyzed separately via a mixed effect model with treatment as~     fixed effect, patient as a random intercept and PR at baseline as a covariate. Least squares~     estimates of the mean difference will be presented, with 95% confidence intervals and a~     two-sided p-value for the treatment effect. P values for secondary endpoints will be~     reported for two-tailed tests of superiority.~   "
83697|NCT01961843|"~     This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests~     (such as laboratory or radiology tests) in patients who receive either standard cancer~     treatments or new treatments that have been well-tested in many patients on other trials.~      It is often difficult to determine how prostate cancer is going to behave when a new~     treatment is started. Physicians have no way to predict how a patient's tumor will respond~     to treatment. Although scientists have learned about changes that happen in tumors due to~     treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to~     remove a small piece of tissue) is needed.~      This study will evaluate a method to detect tumor cells that are circulating in the blood~     without getting a biopsy. It is known that tumors shed a small number of cells into the~     blood stream every day. These are called circulating tumor cells or CTCs. Some early studies~     indicate the amount and type of CTCs in the blood can help determine the status of the tumor~     itself and the way it is responding to treatment. In this study, the investigators will~     examine protein levels in CTCs from patients' blood at different times before and after drug~     treatment to determine if they correlate with response to the drug. The new test will not~     affect whether subjects continue on the study drug.~      Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic~     CRPC. It blocks the remaining or residual male hormones in the body that may be helping~     prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with~     metastatic CRPC who have not yet received docetaxel chemotherapy.~      Abiraterone acetate has been used by a large number of participants in previous clinical~     trials. In most of these trials, participants with CRPC have been given abiraterone acetate~     with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid.~     Prednisone has been approved in the US, Canada, and Europe for various disorders and~     diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of~     prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone~     together with abiraterone acetate will be given in this study in order to reduce or~     eliminate some side effects. Investigators will use patients' blood samples to study the~     genes (also called DNA) and their products (RNA and proteins) found in CTCs.~   "
83698|NCT01961830|"~     This is a single-center, open-label, single-dose study. The primary objective is to~     determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose.~     The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess~     tolerability and safety of a single dose of ME1100 inhalation solution.~   "
83699|NCT01961817|"~     Is there a difference in vocal cord visualization between the retromolar and conventional~     access?~   "
83700|NCT01961804|"~     The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist~     treatment leads to a high risk of bleeding.~      Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to~     reverse anticoagulation with concomitant administration of prothrombin complex concentrates~     (PCCs) and vitamin K.~      However, even if a reversion is performed, the prognostic of post-traumatic intracranial~     bleeding remain bad.~      The investigators hypothesize that, for patients admitted in an emergency department after a~     minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion~     with PCCs can lead to a significant reduction of intracranial haemorrhage and can also~     improve the neurological prognostic of patients versus the current strategy.~      PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial~     involving 400 patients.~   "
83701|NCT01961791|"~     For staging the status of lymph node metastasis in gastric cancer, typographic based staging~     system was applied until last decade, especially in Eastern countries. However the old~     typographic lymph node staging system in gastric cancer was too complicated and less~     accurate for predicting the prognosis. Now the numeric based lymph node staging system is~     used in both East and West, but it include problems: no information on the anatomical extent~     of the disease, preoperative lymph node staging is nearly impossible, failure to provide an~     appropriate treatment plan, cannot represent the extent of lymph node dissection. We~     designed simple and specifically representing the anatomic extent of the disease for staging~     the status of lymph node in gastric cancer. Thus we compared its prognostic performance of~     this new staging system with those of the current TNM 7th edition of AJCC/UICC.~   "
83703|NCT01961765|"~     This research study is evaluating a drug called cabozantinib as a possible treatment for~     acute myeloid leukemia (AML). This research study is a Phase I clinical trial. Phase I~     trials test the safety of an investigational drug or combination of drugs. Phase I studies~     also try to define the appropriate dose of the investigational drug to use for further~     studies. This means that the FDA has not approved giving cabozantinib for use in patients,~     including patients with your type of cancer.~      The study drug cabozantinib works by inhibiting several different proteins which are~     believed to be involved in the growth and multiplication of the cancerous cells associated~     with acute myeloid leukemia. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to prevent~     cancer growth.~      The primary purpose of this research study is to determine the highest dose of Cabozantinib~     that can safely be given without severe or unmanageable side effects. The dose identified in~     this study will be used in future research studies that seek to determine the role of~     cabozantinib as a treatment for AML.~   "
83704|NCT01961752|"~     Although pain is a common complication of endoscopic submucosal dissection (ESD), management~     strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and~     in pain associated with surgery in clinical practice. Further, triamcinolone, a type of~     steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this~     study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for~     abdominal pain relief and as a potential method of pain control after ESD for gastric~     neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection~     after ESD would be effective for pain relief. For this, we designed randomized,~     double-blind, placebo-controlled trial. Eligible patients with early gastric neoplasm were~     randomized into one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone~     (BV-TA), or placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score~     and the Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12~     and 24 h after ESD.~   "
83705|NCT01961739|"~     The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in~     the therapy of symptomatic hemorrhoids. Efficacy will be determined by:~        1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general~          well-being and improvement since the beginning of treatment as separate components of~          CORRECTS scale~        2. the change in overall CORRECTS values from baseline~        3. the change in degree of hemorrhoids from baseline~   "
83706|NCT01961726|"~     A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde~     delivery to cohorts of adults with Ischemic Heart Failure.~   "
83707|NCT01961713|"~     This study will evaluate a method to detect tumor cells that are circulating in the blood~     without getting a biopsy. The investigators already know from other studies that cancer~     tumors shed a small number of cells into the bloodstream every day. These are called~     circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in~     the blood can help determine the status of the tumor itself and the way it is responding to~     treatment. In this study, the investigators will compare the number of CTCs in the blood at~     different time frames before and after surgery to remove the prostate.~   "
83708|NCT01961700|"~     Lung cancer is one of the most common types of cancer in the world, and the cancer that~     causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year.~     About one fifth of the patients are eligible for surgery.~      Patients undergoing thoracic surgery suffer from pain and low health related quality of life~     after surgery.~      In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is~     routinely provided for patients undergoing thoracic surgery, but the effects have not been~     thoroughly investigated. The scientific evidence of the effect of physiotherapy in~     connection with lung surgery is limited. The treatment typically consists of early~     mobilisation, breathing exercises and exercises for the shoulders. Reeve et al has shown~     that a postoperative shoulder exercise program can improve function and decrease pain after~     thoracotomy. Breathing exercises has not been found effective in reducing the rate of~     postoperative pulmonary complications after thoracic surgery.~      The purpose of this study is to investigate the effect of in-hospital physiotherapy~     treatment, for patients undergoing thoracic surgery, on physical activity, health related~     quality of life, pain and lung function.~   "
83709|NCT01961687|"~     Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.~   "
83710|NCT01961674|"~     The primary hypothesis of this study is that consumption of capsinoids increases brown~     adipose tissue activity, detectable by infrared thermal imaging.~      The secondary hypothesis is that consumption of capsinoids can affect an individual's~     glycaemic response.~   "
83711|NCT01961661|"~     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and~     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI~     tracts is influenced by both genetic and environmental factors. Children with CF may harbor~     an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane~     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes~     and acid suppressors). The investigators previously demonstrated that intestinal~     inflammation is highly frequent in CF children, being a major feature of intestinal~     involvement. In addition, specific probiotics significantly improved airway and GI~     inflammation in a preliminary trial. The aim of the study is to characterize intestinal and~     respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus~     GG (LGG) supplementation on both GI and airway microflora and the eventual relationship~     between probiotic assumption and clinical and inflammation markers. The aim is to study the~     effect of microflora modification on intestinal and extraintestinal inflammation to~     eventually improve the quality of life of CF patients, who often suffer from intestinal and~     respiratory progressive disease, through a non invasive intervention consisting in the~     supplementation of probiotic bacteria.~   "
83712|NCT01961648|"~     This study is being conducted to determine whether inhaling exhaled carbon dioxide is~     effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the~     respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles~     and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.~   "
83713|NCT01961635|"~     In patients that require a dental implant, does zirconia compared to titanium, or cad-cam~     acrylic abutments, provide less inflammation, marginal bone loss or infection during the~     osseointegration period ?~   "
83714|NCT01961622|"~     The main objective of this study is to determine whether day and night closed-loop insulin~     delivery for 12 weeks under free living conditions is superior to addition of real-time~     continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control~     on insulin pump therapy.~      This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8~     week run-in period, during which glucose control will be optimised by a professional pump~     educator, followed by two 3 months study periods during which glucose levels will be~     controlled either by an automated closed-loop system or by subjects usual insulin pump~     therapy augmented with real-time continuous glucose monitoring in random order. A total of~     up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on~     insulin pump therapy will be recruited through diabetes clinics and other established~     methods in participating centres. Subjects who drop out of the study within the first 6~     weeks of the first intervention arm will be replaced.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. Subjects will have regular contact with the study team during the home study phase~     including 24/7 telephone support. Subjects will be discouraged from international travel~     during the first two weeks of closed-loop use.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the~     HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other~     CGM-based metrics.~   "
83715|NCT01961609|"~     This study is designed to prove and quantify the hypothesis that secukinumab is effective,~     safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis~     in patients who are inadequate responders to anti-TNFα therapy in a UK (and Republic of~     Ireland) specific population.~   "
83716|NCT01961596|"~     The aim of this study is to investigate the influence of a brief application of cold (by~     means of Cooling Ice Spray on the lateral ankle)on the time to stabilization of healthy~     subjects.~   "
83717|NCT01961583|"~     Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional~     and metabolic responses of biological events with specific radiotracer in vivo. The PET~     tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD~     (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to~     αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and~     mature endothelial cells but are expressed at high levels on activated endothelial cells in~     the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib~     acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can~     be used to predict the effect of this antiangiogenic drug. The investigators expected the~     baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and~     planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received~     pazopanib systemic therapy.~   "
83718|NCT01961570|"~     This study is to evaluate the performance of the Articulinx ICMC~     (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the~     clinical results in patients who have been treated with this device. Expected results~     include the relief of symptoms and improvement of function in patients with symptomatic~     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved~     through measurements of pain, pain medication use, and joint function in up to 20 subjects.~     Each subject will be compared to their pre-surgery status for each endpoint.~   "
83719|NCT01961557|"~     Background:~      - Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch~     gait, an abnormal way of walking. Knee crouch has many causes, so no single device or~     approach works best for everybody. This study s adjustable brace provides many types of~     walking assistance. Researchers will evaluate brace options to find the best solution for~     each participant, and whether one solution works best for the group.~      Objective:~      - To evaluate a new brace to improve crouch gait in children with CP.~      Eligibility:~        -  Children 5 17 years old with CP.~        -  Healthy volunteers 5 17 years old.~      Design:~        -  All participants will be screened with medical history and physical exam.~        -  Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG~          described below.~        -  Participants with CP will have 6 visits.~        -  Visit 1:~      <TAB>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow~     their movement.~      <TAB>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle~     activity.~      <TAB>3. Participants knee movement will be tested.~      <TAB>4. Participants will walk 50 meters.~      <TAB>5. Participants legs will be cast to make custom braces.~        -  Visit 2:~        -  Participants will wear their new braces and have them adjusted.~        -  Steps 1 3 will be repeated.~        -  EEG: Small metal discs will be placed on the participants scalp. They record brain~          waves.~        -  Participants will have electrical stimulation of their knees and practice extending~          them.~        -  Participants will take several walks with the braces in different settings.~        -  Visits 3 5: participants will repeat the walking and some other steps from visit 2.~        -  Visit 6 will repeat visit 2.~   "
83720|NCT01961544|"~     This clinical study is designed as an open, single group, multi-center, phase 4 clinical~     study to assess the safety of eribulin which is approved for the treatment of the patients~     in Korea with locally advanced or metastatic breast cancer who had received two to five~     prior chemotherapy regimens including anthracyclines and taxanes for advanced disease.~      Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the~     investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle.~     In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or~     judgment by investigator that the treatment needs to be stopped, the treatment of~     investigational product is stopped, and treatment termination assessment is performed within~     30 days from the last treatment.~   "
83721|NCT01961531|"~     To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5~     fraction schedule.~   "
83851|NCT01959828|"~     Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary~     hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety~     and efficacy of IK-3001.~   "
84380|NCT01952925|"~     The purpose of this study is to perform renal artery denervation at the same time as atrial~     fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a~     successful atrial fibrillation ablation, and decrease the number of medications required to~     control blood pressure.~   "
83722|NCT01961518|"~     The purpose of this study is to identify patients with Morquio syndrome type A (MPS IVA) and~     Maroteaux-Lamy syndrome (MPS VI) who may have been missed or misdiagnosed due to atypical~     clinical features, a milder course, and/or negative urine screening. We will recruit~     participants who have certain hip and/or joint problems that could potentially be caused by~     one of these two genetic conditions through a chart review process conducted at Shriners~     Hospital for Children in Greenville, SC. Diagnostic testing will be performed for each~     participant to determine if he or she is affected by one of these two conditions. Results~     will be disclosed to all participants and their legal guardians, and appropriate follow up~     will be recommended for those who are found to have abnormal results.~   "
83723|NCT01961505|"~     Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory~     disorder that may affect many synovial joints, and may cause serious disability. It has been~     confirmed that tripterygium extract has effects of anti-inflammatory, immunosuppressive and~     cartilage protection. This is a prospective randomized controlled study to evaluated the~     efficacy and safety of external application with compound tripterygium gel in treating of~     patients with rheumatoid arthritis (RA).~   "
83724|NCT01961492|"~     The purpose of this study is to find out whether a single fecal microbiota transplantation~     is an effective and safe treatment as an adjunct to standard therapy in patients with~     ulcerative colitis.~   "
83725|NCT01961479|"~     The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective~     in reducing the impairment caused by premenstrual symptoms.~   "
83726|NCT01961466|"~     This study is based on the analysis of psychological and social questionnaires filled in by~     diabetic patients whose glycemic balance will be assessed by measuring blood levels of~     glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic~     patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile~     evaluated by the Bortner self-questionnaire.~   "
83727|NCT01961453|"~     The purpose of this research study is to test whether treatment with isosorbide mononitrate~     will improve left ventricular hypertrophy (thickening) which puts people at risk for~     developing heart failure. Once it develops, heart failure is a very serious condition and~     thus it is important to find ways to prevent it from happening. The investigators have~     reasons to believe that dilating the blood vessels with this specific medication will~     improve the thickening of the heart, which increases the risk of heart failure.~   "
83728|NCT01961440|"~     This research is to establish a simple and practical system to predict the prognosis of~     sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity~     of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which~     were easier to evaluate and more influential， were included to establish a prognosis scoring~     system．The scorings of a new score system and MELD were graded at the same time in the~     patients with sever hepatitis B. And then the distribution figures of survival rates and~     mortality rates were done according to the scores from low to high. The features of~     distribution figures of two score system in survival rates and mortality rates and~     significances of clinical application in certain score were interpreted.~   "
83729|NCT01961427|"~     It was shown by some researchers that dietary nitrate such as beet root juice can lower~     oxygen consumption in men and act as a performance enhancing supplement.~      It was not shown, what the optimal dosage is and if there is any difference in oxygen~     consumption comparing beet root juice and inorganic nitrate.~      Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and~     beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at~     different time points and the subjects have to perform an exercise test measuring oxygen~     consumption 3 hours after the ingestion of nitrate.~   "
83730|NCT01961414|"~     The purpose of this research study is to determine if a Treat and Extend regimen~     (increasing the time between visits when the disease is stable and not getting worse) of~     aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related~     Macular Degeneration.~   "
83731|NCT01961401|"~     Exercise training is recognized as effective in preventing and treating many chronic~     metabolic disorders (1), and long-term exercise programmes have similar effects on glucose~     control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise~     intensity and volume of aerobic exercise needed to produce the most wanted effects on~     targeted risk factors for subjects at risk of/with established type 2 diabetes, is still~     uncertain. In this study the investigators will investigate the acute effects of a single~     bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women~     with and without gestational diabetes mellitus (GDM). The investigators think that very~     short bouts of high intensity exercise can be a way to reduce blood glucose in these women.~   "
83732|NCT01961388|"~     The study is designed as non interventional to collect data on the effectiveness of acarbose~     and metformin monotherapy, respectively, in terms of change from baseline in post prandial~     blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within~     each carbohydrates consumption subgroup under real-life treatment condition in large sample~     of type-2 diabetes patients in India. The study will begin after the study approval by~     ethics committee.All drug naïve patients in whom decision to administer acarbose or~     metformin monotherapy for type 2 diabetes management has been made will be included in study~     after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The~     study involves general examination of patients, collection of data like history of disease,~     concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll~     12250 subjects from multiple study centers spread across India. The study data will be~     analyzed with appropriate statistical methods.~   "
83733|NCT01961375|"~     The study is designed as non interventional to observe the continuation rate and the patient~     satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system)~     inserted for contraception over the period of 12 months under real life condition in~     India.The study will begin after the study approval by ethics committee.All Indian women~     aged between 18-49 years who are initiating LNG IUS therapy for contraception will be~     included in study after taking the informed consent.Patients will be observed for upto 12~     months.The study involves general examination of patients, collection of data like medical~     history, previous contraceptive use,concomitant medication etc.The study is planned to~     enroll 600 subjects from multiple study centers spread across India. The study data will be~     analyzed with appropriate statistical methods.~   "
83736|NCT01961336|"~     Ιt has been suggested that the accumulation of androgens in the micro milieu of the primate~     ovary, plays a critical role in early follicular development and granulosa cell~     proliferation. Increased intraovarian concentration of androgens seems to augment follicle~     stimulating hormone (FSH) receptor expression in granulosa cells and thus, potentially~     leading to enhanced responsiveness of ovaries to FSH. In addition, androgen excess has been~     shown to stimulate early stages of follicular growth and increase the number of pre-antral~     and antral follicles.~      On the basis of these data, it has been hypothesized that increasing androgen concentration~     in the ovarian micro milieu in poorly responding patients might lead to an increase in the~     number and the maturity of oocytes after ovarian stimulation for IVF. Hence, recent efforts~     have been focused on the potential benefit of androgen administration in the probability of~     pregnancy in poor responders undergoing ovarian stimulation for IVF.~      Pretreatment with transdermal testosterone has been suggested as a safe and effective way of~     increasing the intraovarian androgen concentration. Recently, published, randomized control~     trials (RCTs) have evaluated transdermal testosterone in poor responders undergoing ovarian~     stimulation for IVF, with inconclusive results.~      In view of the conflicting or inconclusive data regarding the efficacy of the proposed~     intervention, this study will attempt to explore the role of transdermal testosterone~     pretreatment in poor responders undergoing IVF through a properly designed RCT. The lack of~     a universal definition of poor responders has been identified previously and recently, in an~     attempt to address this issue, universal criteria for the definition of poor ovarian~     response have been proposed following a consensus meeting in Bologna. In the present study,~     the Bologna criteria will be used on the contrary to previous studies.~      Despite the advancement in assisted reproduction technologies, poor ovarian response (POR)~     is still considered to be one of the most challenging tasks in reproductive medicine. Poor~     ovarian response is considered to be an inadequate response to ovarian stimulation, defined~     usually by a low number of oocytes retrieved or a low number of developing follicles in a~     previous or in the running, respectively, in vitro fertilization (IVF) cycle. Given the~     severely diminished probability of pregnancy after IVF in these patients, the identification~     of an indisputably efficacious treatment, such as testosterone pretreatment, would be a~     promising alternative for poor responders undergoing IVF.~   "
83737|NCT01961323|"~     To investigate whether treatment with Nebivolol in subjects with high blood pressure and~     abnormal filling of left ventricle (LVDD) improves exercise time by improving Left~     Ventricular deformation and filling.~   "
83738|NCT01961310|"~     The main objective of this study is to compare the intestinal microbiota in newly diagnosed~     rheumatoid arthritis (RA) with that from individuals without RA.~      The first analysis will compare the proportion of filamentous bacteria in the intestinal~     microbiota between the two groups.~   "
83739|NCT01961297|"~     The proposed research aims to determine brain abnormalities in patients with spasmodic~     dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms~     underlying symptom improvement following the use of sodium oxybate, a novel oral medication~     for the treatment of ethanol-responsive dystonia. The proposed research is relevant to~     public health because the elucidation of disorder-specific mechanistic aspects of brain~     organization in SD vs. SD/VT is ultimately expected to lead to establishment of enhanced~     criteria for clinical management of these disorders, including differential diagnosis and~     treatment. Thus, the proposed research is relevant to the part of NIH's mission that~     pertains to developing fundamental knowledge that will help to reduce the burdens of human~     disability.~   "
83740|NCT01961284|"~     Dental implants are used for replacing missing teeth. Placing dental implants is limited by~     the presence of adequate bone volume permitting their anchorage. In order to solve this~     problem several bone augmentation procedures have been developed. In principle the missing~     bone is taken from a donor site (for example the hip), transplanted where needed and then~     implants are placed. Sometimes, major bone grafting operations have to be undertaken under~     general anaesthesia requiring patients to be hospitalised for a few days. Some degree of~     morbidity related to the donor site must be expected, though more recently bone substitutes~     are used to minimize morbidity, and 2 to 3 surgical interventions may be needed before the~     implants can be functionally used. Sometimes patients have to wait more than 1 year before a~     prosthesis can be fixed to the implants and the total cost of the treatment is high. At the~     beginning of the 1990s a long screwshaped implant was developed by Professor PI Brånemark as~     an alternative to bone augmentation procedures: the zygomatic implant. Zygomatic implants~     are generally inserted through the palate to engage the body of the cheek bone. One to three~     zygomatic implants can be inserted through the posterior palate to engage the body of each~     cheek bone. The potential main advantages of zygomatic implants could be that bone grafting~     may not be needed and a fixed prosthesis could be fitted the same day of their placement.~     Despite that zygomatic implants have been used for more than 20 years, their effectiveness~     has never been compared with conventional dental implants in augmented maxillae. The aim of~     the project is to compare the longtermclinical outcome of fullarch upper jaw bridges~     supported by zygomatic implants versus conventional implants placed in augmented bone in the~     palate.~   "
83741|NCT01961271|"~     The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch~     (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of~     moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain~     and joint/muscle pain, who are not adequately responding to non-opioid painkillers.~   "
83742|NCT01961258|"~     SEVERE ASTHMA IN THE COMMUNITY-~      BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people~     have asthma but it is estimated that only 5% of these patients have severe asthma. Although~     severe asthma comprises a small fraction of the entire asthmatic population its share in~     the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among~     adult patients is about 5-6% but the prevalence of severe asthma is unknown.~      The definition of severe asthma has been changed during the years. Most recently in 2009 the~     WHO agreed on a unified definition of severe asthma that would fit countries of different~     socioeconomic development [1]. Severe asthma includes now 3 different groups: group one~     untreated severe asthma, group two difficult to treat severe asthma and group three~     treatment-resistant severe asthma. As all asthmatic patients in Israel have easy access to~     medical care, the current study will deal with the last two groups (difficult to treat~     asthma and treatment resistant asthma).~      AIMS Primary endpoints:~        1. To identify the prevalence of severe asthma in the community according to the WHO~          definition of group two & three.~        2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of~          severe asthma.~      Secondary endpoints:~        1. To assess factors involved in difficult to treat asthma according to the WHO~          definition. Factors as patient compliance, presence of co-morbidities, symptoms of~          untreated potential asthma triggers including GE reflux, post nasal drip/atopic~          rhino-sinusitis, and intervening medications including NSAID and beta-blockers.~        2. To asses the level of asthma control, level of patient follow-up care including asthma~          specialist visits, periodic PFT's and asthma education.~        3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE~          therapy according to the indications of the Israeli Ministry of Health (proven asthma,~          uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of~          systemic corticosteroids in the last year + proven atopy to at least one perennial~          aeroallergen + IgE level of 30-1,500 IU/ml)~      DESIGN A prospective non-blinded non-randomized observation study among the population~     insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.~   "
83760|NCT01961024|"~     In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2~     diabetic and healthy subjects matched for BMI in order to elucidate the potential~     pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in~     abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of~     fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal~     muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes~     that might be involved in regulating skeletal muscle and adipose tissue FA storage.~   "
83743|NCT01961245|"~     It has been shown, that in patients with very severe chronic obstructive pulmonary disease~     (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR)~     may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques~     provides a better recovery of the respiratory pump during the night. If non-invasive~     ventilation also decreases the metabolic demands during night is unknown and is aim of this~     study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients~     with chronic obstructive pulmonary disease stage IV will be recruited for this study. There~     will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a~     non-invasive ventilation will be involved in the intervention group where non-invasive~     ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease~     stage IV without an indication for the use of non-invasive ventilation will be involved in a~     control group to detect the changes in nocturnal energy expenditure produced by pulmonary~     rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be~     repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the~     pulmonary rehabilitation program.~      A sub-trial of this study is to validate night movement accuracy of the Dynaport activity~     monitor with the observations made by a night-vision camera in the sleep lab. This will be~     performed in study participants as well as in healthy volunteers.~   "
83744|NCT01961232|"~     The investigators are testing whether the addition of Pulmonary Hypertension-related~     biomarkers, measured across the pulmonary circulation, to the standard hemodynamic~     evaluation for Pulmonary Hypertension will lead to more informed choices of Pulmonary~     Hypertension therapy and improved patient outcomes.~   "
83745|NCT01961219|"~     Shoulder pain is one of the most common causes of musculoskeletal disability in the adult~     population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder~     pain and dysfunction. It is a painful and disabling condition that can cause frustration for~     patients and caregivers due to slow recovery time. It is important to meticulously diagnose~     the source of the symptoms. Adhesive capsulitis is treatment by non-operative therapies such~     as physical therapy, exercise, steroids & pain medications. For some patients a quicker~     return to function is necessary; in th is situation an operative treatment is an option.~     This study will compare two surgical techniques for adhesive capsulitis.~      Purpose~        1. To directly compare outcomes of patients with adhesive capsulitis who have failed pain~          management and failed improvement in range of motion after at least 3 months of~          supervised, regimented conservative treatment and have subsequently been randomized to~          either closed manipulation under anesthesia or arthroscopic capsular release.~        2. To blind both patient and assessing physician/nurse study coordinator to the treatment~          that was received for the duration of the study. This will reduce the effect of any~          potential bias on the results as much as possible.~        3. To collect outcome data, both subjectively from the patient using proven outcome~          measures, and objectively from regularly spaced follow up visits with blinded~          assessors.~        4. To collect and comment on data from the two treatment groups regarding duration of~          post-operative narcotic use, duration of post-operative physical therapy required,~          post-operative pain levels, and elapsed time until back to work/activity~          post-operatively.~   "
83746|NCT01961206|"~     Escherichia coli is the leading cause of community-onset gram-negative bloodstream~     infections. There has been a dramatic increase in the prevalence of extended-spectrum~     b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be~     exclusively a nosocomial pathogen in recent years. As a result, the treatment options for~     community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the~     initial empirical therapy is often ineffective and associated with increased mortality.~     Although there were some reports of the risk factors of community-onset ESBL producing E.~     coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore,~     the investigators aim was to investigate the epidemiology, risk factors, and the hospital~     outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or~     K.pneumoniae in China.~   "
83747|NCT01961193|"~     Study Rationale:~      The insertion of a bandage contact lens or punctal plug in a defined group of patients~     admitted to the ICU may be more effective than standard care in decreasing the incidence of~     corneal injuries.~      Study Objectives:~        1. To document the effect of a contact bandage lens and punctal plug in preventing corneal~          injuries in critically ill patients admitted to the ICU.~        2. To assess the safety of a contact bandage lens and punctal plug in critically ill~          patients.~   "
83748|NCT01961180|"~     Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose~     metabolism, physical and mental health and quality of life in polycystic ovary~     syndrome(PCOS).~      Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.~   "
83749|NCT01961167|"~     The primary objective of the GORE® PI-13-05 clinical study is to evaluate the safety and~     efficacy of PI 13-05 for the treatment of arterial occlusive disease in patients with de~     novo or restenotic lesions in the common and/or external iliac arteries.~   "
83750|NCT01961154|"~     Background:~      The most common asthma drugs, namely inhaled glucocorticoids (ICS) and long-acting beta-2~     sympathomimetic drugs (LABA) carry a risk of adverse effects, some of which being~     potentially severe. Therefore, current guidelines for asthma management recommend that,~     after a period of symptom control, a reduction of the dose and cessation of the ICSs and~     LABAs should be attempted. However, reduction in asthma medications sometimes leads to an~     exacerbation of asthma. Therefore both physicians and asthmatics are often reluctant to~     reduce or stop asthma medications and asthma over-medication often occurs. A test that could~     identify those asthmatics who probably would tolerate asthma medication reduction would be~     useful.~      Objectives:~        1. To investigate whether airway responsiveness to hypertonic saline can predict the~          outcome of asthma treatment reduction in subjects with controlled asthma.~        2. To get an estimate about how large a proportion of Finnish asthmatic patients use their~          medications with unnecessarily high doses or would even manage well without any asthma~          medications.~      Study hypothesis:~        1. Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment~          reduction~        2. Most of the Finnish asthmatic patients use their medications with unnecessarily high~          doses~      Methods:~      This is a prospective study in which the physician responsible for the subject management~     and medications is blinded from the saline challenge results and the nurse performing the~     saline challenges is blinded from medications 70 asthmatic patients with both inhaled ICS~     and LABA will be recruited. Asthma must be well controlled (Juniper's Asthma Control~     Questionnaire score equal or less than 0.75 ).~      The asthma medications will be reduced in three steps, in six weeks' intervals, up to total~     cessation of asthma drugs or up to asthma exacerbation. The criteria for asthma exacerbation~     are strictly defined. First step: LABA will be discontinued. The ICS is continued. Second~     step: medium to high daily ICS dose is reduced to low daily dose. Third step: The low ICS~     dose will be stopped. Before each reduction, saline challenge will be performed. Asthma~     diary is kept throughout the study and the subjects will be provided a direct telephone~     number to a respiratory physician during all hours of day.~   "
83751|NCT01961141|"~     Historically, ultrasound has been unable to provide interpretable data from the lung~     parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by~     the air in the lungs. Recently it has been shown that clear reproducible Doppler signals can~     be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system~     incorporating a special signal processing package (transthoracic parametric Doppler, TPD,~     EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with~     the cardiac cycle and can be obtained from the lungs, including areas remote from the heart~     and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s~     and are of relatively high power, making it possible to detect them despite the~     aforementioned attenuation by the air in the lungs. The LDS are thought to represent the~     radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of~     cardiac origin which propagate throughout the lung vasculature. The LDS may contain~     information of significant diagnostic and physiological value regarding the pulmonary~     parenchyma and vasculature, as well as the cardio-vascular system in general.~      Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF,~     COPD and pulmonary hypertension, show promise regarding the diagnostic potential of the lung~     Doppler signals (unpublished data). However, lung Doppler signals in acute disease states~     were not investigated so far. It is reasonable to speculate that the pathological processes~     underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the~     TPD may have diagnostic potential in these conditions. For example, during acute pulmonary~     embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable~     to assume that the LDS will disappear in the affected area, enabling to confirm the~     diagnosis without using ionizing radiation (as in CT or lung scan). Another example is COPD~     exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be~     attenuated by the increase of air volume in the lungs.~   "
83752|NCT01961128|"~     This study is being done to see if the investigators can measure changes that occur in~     breast tissue when women at risk of developing breast cancer start an exercise program. The~     investigators are interested in studying this because research shows that women who exercise~     regularly are less likely to develop breast cancer, but there is not very much information~     explaining how exercise could affect breast cells in a way to prevent cancer from occurring.~     In this research study the investigators will use a research technique called breast random~     fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The~     investigators will look at breast cells before and after a participant takes part in an~     exercise program to see if the investigators are able to see any changes in breast cells~     that could have happened due to the exercise program. This research will help us to develop~     larger projects to see if exercise programs could be helpful in preventing breast cancer.~   "
83753|NCT01961115|"~     This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating~     patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Vaccines made from peptides and~     antigens may help the body build an effective immune response to kill tumor cells. Giving~     epacadostat with vaccine therapy may be an effective treatment for advanced melanoma.~   "
83754|NCT01961102|"~     It is to be achieved that in postmenopausal women through the combination of Hysteroscopy~     and intraoperative rapid section a positive predictive value (PPV) regarding the objective~     illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative~     predictive value (NPV) of 99%.~   "
83755|NCT01961089|"~     Study question: How does the new GALILEI Lens Professional compare to predicate devices?~     Study hypothesis: The GALILEI Lens Professional achieves a better precision in the~     postoperative, calculated target refraction with cataract surgeries than predicate devices,~     and it is more versatile in the measurable parameters as well as more user-friendly.~   "
83756|NCT01961076|"~     In this clinical cross-over study, we will compare the efficacy of different oral nutrition~     regimens for night-time glucose control in adult GSD 1 patients. Three different over-night~     nutrition regimens (=interventions) will be compared in each patient sequentially, (1)~     uncooked corn starch (UCSS, Maizena), (2) modified corn-starch, (3) other carbohydrate~     (starch) containing meal. During each intervention, glucose profiles will be continuously~     monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d~     (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the~     technical quality of glucose sensor readings. Between the interventions, the patients follow~     their normal prescribed diet.~   "
83757|NCT01961063|"~     This pilot clinical trial studies gene therapy after frontline chemotherapy in treating~     patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma (NHL).~     Placing genes for anti-human immunodeficiency virus (HIV) ribonucleic acid (RNA) into~     stem/progenitor cells may make the body build an immune response to AIDS. Giving the~     chemotherapy drug busulfan before gene therapy can help gene-modified cells engraft and work~     better.~   "
83758|NCT01961050|"~     The purpose of this study is to evaluate an intervention aimed at reducing risk for~     alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian~     children. The study will determine whether physicians, trained in a dual-focused brief~     motivational intervention and monitored for performance, can foster greater change in~     knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women~     who are at risk than standard care.~   "
83759|NCT01961037|"~     Falls are the leading cause of death and injuries in adults over age 65 both nationally and~     in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as~     arthritis, are strong risk factors for falls in this population. West Virginia has a higher~     than average fall rate, the second oldest population, the greatest proportion of inactive~     adults, and the second highest prevalence of arthritis in the US. Thus, older adults in~     rural West Virginia are at high risk for falls and in great need of public health fall~     prevention programs. The Tai Chi: Moving for Better Balance (MFBB) program is a~     community-based, fall-prevention exercise program for older adults. A waiver of informed~     consent will be requested to conduct the telephone screenings to determine study~     eligibility. We will enroll up to 300 people in classes to be held at 20 churches in West~     Virginia. Classes will be held twice per week for 16 weeks and taught by certified MFBB~     instructors. Participants will be interviewed by telephone, have a brief physical function~     ability exam, and complete a questionnaire before starting the exercise class, at the end of~     the class, and 4 months later. The study is being conducted to answer the following~     questions: 1) What are the functional improvements of older adults who participate in a~     16-week MFBB program; 2) What is the rate of falls for those adults; 3) What is the rate and~     severity of those fall-related injuries of the MFBB participants? The purpose of the study~     is to: 1) implement a 16-week intervention of MFBB with a 16-week follow-up, in older adults~     in churches in rural West Virginia; 2) describe functional and fall/injury outcomes.~     Ultimately, we will translate an efficacious and effective fall-prevention intervention into~     a new setting.~   "
83761|NCT01961011|"~     Carpal tunnel release is a well accepted treatment for median nerve compression at the~     wrist. With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With~     a number of anatomic as well as systemic factors playing a role in the development of carpal~     tunnel syndrome, it is not surprising that there is a high incidence of bilaterality with~     this disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms~     of carpal tunnel syndrome in their contralateral hand.~      In patients who have bilateral carpal tunnel syndrome that has not responded to conservative~     treatment, surgical release is indicated. In such cases, a decision must be made whether to~     offer bilateral simultaneous surgical release or to stage the two affected hands to allow~     time to recover from each.~      The purpose of this study is to determine the differences in short term disability between~     having bilateral vs unilateral carpal tunnel release. With better understanding of the way~     in which patients are impaired, better recommendations may be made on which patients to~     indicate for simultaneous bilateral procedures and who would benefit from staging~     procedures, allowing the patient to recover from one hand prior to proceeding to surgery on~     the other hand.~   "
83762|NCT01960998|"~     Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but~     pelvic floor muscle training and exercise (including urine control strategies) have been~     shown to reduce the time to regaining urine control. This study tests an evidence-based,~     pelvic floor muscle training program that has been adapted to telehealth format and pilot~     tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery~     and continued 6 months after surgery. Content is accessed on a secure website in daily~     10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the~     investigators' pilot study, Veterans reported that they appreciated receiving the training~     in the privacy of their homes, enjoyed the interactive style of the learning experience, and~     felt better prepared to deal with urine leakage and empowered with new knowledge and skills~     to help themselves. Content for both control and treatment groups includes general~     information about prostate cancer; perioperative care; wetness, odor and skin care~     management. The treatment group will ALSO receive pelvic floor muscle training and bladder~     control strategies. Outcomes are measured with brief validated questions administered by the~     telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth~     platform.~   "
83763|NCT01960985|"~     Verifying the efficiency of motor training associated with visual and auditory cues on the~     balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's~     Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized~     clinical trial performed at Center of Research of the courses of Speech Therapy, Physical~     Therapy and Occupational Therapy of São Paulo University.~   "
83764|NCT01960972|"~     This protocol aims to implement, using a stepped wedge trial design, a population-level~     intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium~     salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban~     area of Tumbes.~      We hypothesize that participants aged 18 years and over from villages receiving a salt~     substitute will have lower blood pressure compared to control villages.~   "
83765|NCT01960946|"~     This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood~     pressure. MCP is a dietary supplement that is derived from plants, and therefore is not~     subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been~     deemed as 'generally regarded as safe' by the FDA.~      This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood~     pressure. The study will help understand how MCP may affect the risk for heart disease in~     patients with high blood pressure.~   "
83766|NCT01960933|"~     In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute~     angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel~     disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to~     provide evidence as to whether full revascularization or revascularization of the culprit~     lesion only provides the best prognosis for the patient.~   "
83767|NCT01960920|"~     Exposure to air pollution is associated with increase in cardiovascular morbidity and~     mortality. Controlled human exposure studies have demonstrated impaired vascular function~     and heart rate variability on healthy volunteers. The aim of this study is to investigate~     the effects of reducting diesel exhaust inhalation on endothelial function, heart rate~     variability and cardiopulmonary stress testing in healthy volunteers and patients with~     chronic heart failure, by using a filter mask.~   "
83768|NCT01960907|"~     The CHROMED project focuses its investigation on the applicability of an integrated solution~     for a pathological condition which: a) is very prevalent in ageing patients and b) severely~     impairs quality of life: COPD with other typical comorbidities such as congestive heart~     failure and sleep disordered breathing. A specific ICT platform in combination with a set of~     innovative devices will be used to collect and process useful clinical data at the patient's~     home and used to optimize their medical treatment. To evaluate the impact of this solution,~     an international multi-centric randomized control trial will be implemented in five European~     regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social~     and organizational contexts in Europe.~   "
83769|NCT01960894|"~     If the heart fails to pump a sufficient amount of blood, it is crucial to know why in order~     to provide the best treatment. Pressure-volume analysis is the gold standard for evaluating~     the heart's pumping function. Unfortunately, current techniques are invasive, so most~     patients will not get this examination. By combining the strengths of echo-Doppler~     ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to~     develop a non-invasive method for pressure-volume analysis, extending its applicability to~     more patients and settings.~   "
83770|NCT01960881|"~     Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients~     Managed with Lupron.~   "
83879|NCT01959464|"~     The purpose of this study is to determine if sexual intercourse lowers serum progesterone in~     women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their~     male sexual partners. We hypothesize, based on previous estrogen studies done by our group,~     that intercourse will interfere with absorption of vaginal progesterone.~   "
83771|NCT01960868|"~     Liver transplantation is the last surgical treatment for patients with acute or chronic~     liver disease. Transplantation therapies technics are in constant evolution. It allows an~     increasing survivals rates and time to come back to daily activities. The postoperative~     treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in~     Intensive Care Unit (ICU).This postoperative phase is one of the most important steps~     regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical~     abilities transplantation are likely to be important in the postoperative. It appears that~     pre-transplant subjects have a weakened muscle potential, they will increase it~     significantly in the months after transplantation with a rehabilitation program adapted~     (Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by~     sedation and ICU length of stay are major factor for increasing complications as respiratory~     disorders and muscle weakness. Several studies have reported feasibility and safety an early~     mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007;~     Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs~     encompass muscle strength assessment, passive range of motion, active mobility, sitting on~     the edge of bed, standing and walking, which would be related to the primary disease of LT~     (Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible~     with the Medical Research Council score (MRC score). The MRC score consists in an assessment~     of three muscle groups of upper and lower limbs. Sitting positions and verticalization are~     included in programs begun as soon as possible after surgery evaluation of the response~     level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the~     physiotherapist are established in legal texts making him a key in the assessment and~     management of these patients on musculoskeletal and respiratory domains.~      The purpose of this study is to validate data feasibility and tolerance. Another aim is also~     to assess the length of stay in ICU, of early mobility and physical program, started in the~     postoperative period in a population of patients with liver transplantation, during their~     stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open,~     randomized monocentric comparing two groups of patient liver transplanted. The control group~     will receive the standard treatment used in the ICU and the experimental group will receive~     a protocol of early mobilization according to data from recent literature on the subject.~     The study is scheduled to last over one year and included patients will receive physical~     therapy on five days a week with a frequency of one to several times per day depending on~     the clinical requirements or conditions of the study.~   "
83772|NCT01960855|"~     This is a multi center, randomized, double-blind, placebo-controlled phase 2 study in~     subjects with moderately to severely active rheumatoid arthritis on background methotrexate~     who have failed anti-Tumor Necrosis Factor (TNF) biologic therapy.~   "
83773|NCT01960842|"~     The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects~     with advanced Parkinson's disease.~   "
83774|NCT01960829|"~     This is a single-armed, open-labeled and single-centered study of everolimus in selective~     patients with metastatic melanoma for evaluation of the efficacy and safety. The study~     objective is to evaluate efficacy profile of everolimus.~      The patients who comply with the inclusion and exclusion criteria will be enrolled. The~     estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg~     orally each day at lease 6 months unless disease progression or intolerance. The follow-up~     is till death(at least 1 year).~   "
83775|NCT01960816|"~     Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing~   "
83776|NCT01960803|"~     The overall objective of this study is to determine the feasibility and tolerability of~     single dose Intraoperative Electron Radiation Treatment (IOERT) as definitive therapy when~     administered at the time of breast conserving surgery for patients with early stage breast~     cancer.~   "
83777|NCT01960790|"~     This investigation will be conducted to obtain the following information regarding the use~     of Adalimumab 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal~     Behcet's Disease.~        1. Incidence and conditions of occurrence of adverse reactions in clinical practice~        2. Factors likely to affect the safety and effectiveness~   "
83778|NCT01960777|"~     The objective of this study is to evaluate chronic pain after inguinal hernia repair~     involving mesh placement with the Onstep-technique compared to mesh placement using a~     laparoscopic approach. The study hypothesis is that an even or smaller proportions of~     patients operated the Onstep technique will have chronic pain that impairs daily function.~   "
83779|NCT01960764|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective antimicrobial Staphylococcal species such as~     Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that~     play a role in protecting the skin from invading pathogens. In this study, the investigator~     will attempt to decrease S. aureus colonization and increase colonization by protective~     Staph species. First the investigator will culture the bacteria on subjects' lesional AD~     skin. The investigator will selectively grow the subject's antimicrobial Staph colonies and~     place them into a base moisturizer. The moisturizer plus bacteria will be applied to both of~     the subject's arms. Prior to applying this, though, one arm will first be pre-treated with~     an antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then~     compare the abundance of antimicrobial Staph species on each subject's arms 24 hours later~     to determine whether the pre-treatment regimen increased survival of the transplanted~     antimicrobial Staph species. The investigator expects that the arm pre-treated with the~     antimicrobial regimen will have more antimicrobial Staph species at this time point.~   "
83780|NCT01960751|"~     Context: Studies that address specifically the neurocognitive consequences that can be~     caused by low-dose radiation receiving during the childhood have still to be performed. In~     this issue, we focus on an investigation with patients who have received radiotherapy for a~     benign tumor (skin hemangioma), in France.~      Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave~     Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy.~     These patients have been treated and followed by Gustave Roussy, so their clinical records~     can be tracked with great accuracy and the ionizing radiation dose to the brain have been~     estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or~     disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A~     total of 150 patients is expected. They will be contacted by letter to explain the purpose~     and methods of carrying out tests. Two groups will be analysed according to the received~     ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs~     unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory,~     arithmetic, orientation, etc.) will be used.~      Expected results: We expect to describe the potential neurocognitive dysfunction or disorder~     and to identify risk factors and brain structures whose lesions are responsible for the~     neurocognitive dysfunction or disorder.~      A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive~     dysfunction or disorder.~   "
83781|NCT01960738|"~     To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving~     mishaps in recreational divers.~   "
83782|NCT01960725|"~     This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus~     vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2~     months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of~     age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and~     4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to~     the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from~     subjects one month following the final dose of vaccine and will be assayed for~     anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4~     and P[8] serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers~     (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5)~     according to the alternate dosing schedule versus the standard recommended schedule.~     Likewise, post dose 3 G2, G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared~     between children receiving RV5 according to the alternate dosing schedule and the standard~     recommended schedule. The safety and tolerability of RV5 in children receiving vaccine~     according to the alternate dosing schedule will be described.~   "
83783|NCT01960712|"~     Bile leakage after liver transection is treated by external drainage. The question addressed~     is whether downstream control by transpapillary stent insertion into distal bile duct can~     enhance healing.~   "
83784|NCT01960699|"~     Background: Cardiac arrest is a life-threatening event. Intensivists are challenged with an~     increasing number of patients with uncertain neurological outcome following cardiopulmonary~     resuscitation (CPR). The prognostic value of current biomarkers for neurophysiologic~     long-term outcome is limited.~      Hypothesis: We hypothesize that specific brain-derived tissue leakage proteins can be~     identified to reveal novel, more reliable prognostic biomarkers for good neurological~     outcome.~      Methods: This translational study (n=100) is a combination of a prospective basic science~     study intended to reduce the number of potential plasma biomarker candidates by proteomic~     shotgun analyses in brain tissue autopsy samples and plasma samples from resuscitated~     patients (n=10) and a prospective clinical validation study in a large study population~     (n=100) by high-throughput analyses. Selection of proteomic markers and signature estimation~     will be performed to discriminate patients with good and poor outcome.~      Clinical perspective: A structured proteomic analysis approach might identify the best~     marker out of all proteins liberated during cellular damage.~   "
83785|NCT01960686|"~     The purpose of this study is to evaluate the immunogenicity and safety of multiple~     formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of~     child-bearing age.~   "
83786|NCT01960673|"~     Generally, the laryngeal mask airway is not considered in the surgery which should be~     changing position in the perioperative period. The shape of the pharynx changes during the~     head and neck movement and there is probably also a change in the force transmitted to the~     cuff along the airway tube. Besides, there is evidence that supraglottic airway device can~     be displaced with rotation. In this article, the investigators want to discuss about that~     oropharyngeal leak pressure and sealing between the mask and vocal cord while changing head~     and neck position in perioperative period using different types of supraglottic airway~     device.~   "
83787|NCT01960660|"~     Supplementation with omega-3 fatty acids has been extensively researched and is known to~     provide healthful benefits for patients with a diversity of conditions and diseases. Not all~     omega-3 supplements are created equally however; some sources of omega-3 fatty acids are~     superior to others due to a greater bioavailability of omega-3 fatty acids than others,~     differences in source material, and processing techniques.~      The purpose of this study is to determine which marketed omega-3 product provided the~     greatest effect, as measured against its' label claim and recommended dosage.~   "
83788|NCT01960647|"~     The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study~     is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous~     transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo~     occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal~     arteries.~   "
83789|NCT01960634|"~     This is a multi-centric translational study with biological samples collection. The aim of~     this study is to validate a method to detect BRAFV600 in blood samples.~      Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard~     medical practice.~      The treatment is not the aim of the study. Patients can be treated either with specific or~     no-specific drug.~   "
83790|NCT01960621|"~     The investigators want to see whether the test drug in this research study,~     2-hydroxypropyl-beta-cyclodextrin (2HPBCD), might potentially be able to improve cough in~     healthy volunteers. The investigators are initially recruiting healthy volunteers such as~     who are free from any respiratory disease and not on any concurrent medication, so there are~     no confusing effects from pre-existing respiratory symptoms or disease, nor interaction of~     any medication with the test drug.~   "
83791|NCT01960608|"~     Increasing sodium intake raises blood pressure. And high salt intake could hinder the~     management of chronic disease. Much previous research has confirmed that dietary habits are~     affected by economic status. So we compared sodium intake with economic status. We~     investigated the prevalence, extent and management, and the relevance of sodium intake with~     income level.~   "
83792|NCT01960595|"~     The purpose of this study is to investigate the efficacy and cost analysis of intravenous~     fentanyl combined with either local anesthesia infiltration or peroneal nerves block in~     patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with~     patients without local anesthetics administration perioperatively.~   "
83802|NCT01960465|"~     Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35%~     of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an~     important health problem in Veterans. African Americans with OSA are at increased risk for~     poorly controlled hypertension and its health consequences. Implementing a care plan to~     increase the percentage of Veterans in whom blood pressure goals are achieved has been~     prioritized by Veterans Administration hospitals. Recent studies show that hypertension~     control can be improved with continuous positive airway pressure (CPAP) treatment of OSA.~     The aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour~     arterial blood pressure and central aortic blood pressure (measured non-invasively with a~     cuff on the upper arm) in African American and other Veterans.~   "
83793|NCT01960582|"~     The rationale underlying this project is the fact that HA is a very common compensatory~     interven¬tion within municipality health care, undertaken to support an independent living~     in the own home. In addition, MD are frequently prescribed and used among HA clients in~     order to compensate for declined body functions. In spite of this, knowledge of their~     effects for the individual and the society is still scarce. In particular, systematic,~     evidence-based strategies based on clear-cut conceptual definitions and descriptions of~     procedures are lacking. Such strategies are crucial in order to evaluate the effects of HA~     and MD. In addition, longterm cost-effectiveness evaluations are crucial for policy~     implementation.~      The overarching aim is to investigate outcomes of HA on aspects of home and health for~     sub-groups of persons with disabilities.~      The specific aims are to:~        -  Investigate the effects of HA on home and health related outcomes, i.e. usability, fear~          of falling, activity/participation and health-related quality of life for different~          subgroups of persons, e.g. MD users and non MD-users~        -  Investigate the use of a new practice strategy for HA on home and health related~          outcomes for subgroups of persons with disabilities in terms of differences between~          municipalities~        -  Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life~          years~        -  Gain a deeper understanding of the processes behind changes in outcomes We hypothesise~          that using a structure strategy for housing adaptation and mobility devices case~          management in ordinary practice in Swedish municipalities increase activity,~          participation, the usability of the home, and reduces societal costs.~   "
83794|NCT01960569|"~     Single centre ,Phase IV , interventional, The study includes :~      200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will~     have placebo .~      The patients will be randomized to the active product (arm 1) or to placebo (arm 2).~      The study consists of 4 visits as the following :~        -  Visit 1 : on day 1 to check patient eligibility and also for randomization .~        -  Visit 2 : on day 4 to assess target parameters~        -  Visit 3 : on day 8 to assess target parameters~        -  Visit 4 : on day 16 to assess target parameters~   "
83795|NCT01960556|"~     Catheter associated blood stream infections (CA-BSI) remain a source of significant~     morbidity and mortality in adult and pediatric critical care units. While it has been~     established that CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI~     rates, training and retention of proper bundle compliance remains a challenge.~      The investigators prospectively compared this simulation-based program to a standard~     educational approach.~      The investigators hypothesized that implementation of bedside simulation-based training of~     CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.~   "
83796|NCT01960543|"~     Elderly patients with hip fracture are frail due to associated comorbidity. In these~     situations, regional anesthesia is recommended as it is associated to less postoperative~     cognitive dysfunction. However, hypotension during the process may impair ischemic~     cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and~     the administration of vasoactive drugs during the process can minimize these risks. Although~     bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the~     studies show conflicting results. The aim of this study is to investigate if there are~     clinically relevant differences between these two drugs in terms of hemodynamic parameters~     during the surgical process with special focus on the effects on regional cerebral oximetry~     and cognitive status after surgery.~   "
83797|NCT01960530|"~     This study will investigate a new drug called Infacort®; a newly-developed immediate release~     formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a~     replacement treatment for people whose adrenal glands are not producing enough natural~     cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort®~     acts once inside the body, by measuring cortisol and other hormone levels in the body,~     compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through~     the vein) injection.~      The population who are eligible to take part in the study are healthy male volunteers, aged~     between 18 and 60 years of age.~   "
83798|NCT01960517|"~     This is a single centre, non-randomised, baseline controlled, prospective pilot clinical~     trial to be undertaken at Rotherham General Hospital, Rotherham, UK.~      The study will examine the safety and performance of a new urinary catheter, the Alternative~     Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK)~     which has been developed to reduce the morbidity of long-term catheterisation and the~     acknowledged deficiencies of the conventional Foley urinary catheter.~   "
83799|NCT01960504|"~     BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of~     this study is to assess the safety and clinical performance of the drug eluting absorbable~     metal scaffold (DREAMS 2nd Generation).~   "
83800|NCT01960491|"~     The objective of this study is to evaluate the effectiveness and the safety of the~     intracardiac septal closure device (CBO), as well as the practicability of implantation of~     this device using the accessories (DS for CBO).~   "
83801|NCT01960478|"~     In the USA, every year 795,000 patients suffer a cerebral vascular accident (CVA), which~     represents a yearly cost of $73.7 billion. CVA is the third main cause of death and the main~     source of acquired handicap in adults, as a result it is now a key priority in public health~     and part of  The CVA National Action Plan 2013-2014.~      Copeptin is a polypeptide, by- product of Vasopressin metabolism. The increase of Copeptin~     plasma level, as for Vasopressin, is connected to hydric balance disorders found in~     cardio-vascular, renal and endocrine diseases. This link has already shown its interest in~     the early diagnosis of myocardial infarction and, in a more indirect way, CVA.~      Copeptin is associated with acute endogenous stress. It seems to have interesting potential~     in the diagnosis of CVA by its negative predictive value like D-dimeres in pulmonary~     embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the~     prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis.~   "
83880|NCT01959451|"~     This study investigates whether a platelet function testing guided approach with a~     short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in~     adequate responders to clopidogrel is non-inferior regarding the combined incidence of~     bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in~     acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention~     (PCI).~   "
83803|NCT01960452|"~     Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep,~     and/or non-restorative sleep, leads to significant daytime dysfunction and increased health~     risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but~     the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part~     because of limitations in our ability to image the brain during normal human sleep with~     sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by~     subjective report of the patient and demonstration of changes in sleep latency and/or sleep~     amount which are generally small in magnitude; there are currently no data to demonstrate~     that insomnia treatments correct any functional abnormalities in the sleep process that~     likely contribute to neurobehavioral abnormalities and health risks. The goals of the~     proposed study are to use high density EEG to define abnormalities in specific aspects of~     sleep in insomnia patients compared to healthy sleeping control subjects to define~     biomarkers that will both increase our understanding of the pathophysiology of insomnia as~     well as provide targets to assess treatments for insomnia.~   "
83804|NCT01960439|"~     The purpose of this study of this study is to assess the responsiveness and validity of CIMS~     (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis)~     clinical disease activity by measuring:~      The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo~     Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS~     (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of~     a treatment of known efficacy in UC.~   "
83805|NCT01960426|"~     Utilization of health resources in a testing based strategy versus an empiric dose~     escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss~     of response to infliximab or adalimumab.~   "
83806|NCT01960413|"~     In this feasibility trial, the investigators will compare participants treated with~     montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8~     weeks.~   "
83807|NCT01960400|"~     The efficacy of the current standard non-pharmacological treatments for complex regional~     pain syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is~     suboptimal. It thus appears essential to examine new non-pharmacological therapeutic imagery~     (GMI) - a non-pharmacological approach with the highest level of evidence (level II). As~     suggested by the most recent clinical guideline 2, a potential solution would be to add an~     electrotherapeutic procedure - transcranial direct current stimulation (tDCS) - that may~     prove effective in modulating cortical excitability and reducing the effect of cortical~     reorganization on pain. Given the positive results previously obtained in patients with~     neuropathic pain, it is hypothesized that tDCS will prove to be an innovative add-on~     treatment method for CRPS patients, and help reduce pain and disability.~   "
83808|NCT01960387|"~     The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated~     treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For~     this prospective study, we propose the use of clofarabine and cytarabine for second course~     induction therapy for patients with persistent AML after treatment with an anthracycline and~     cytarabine.~   "
83809|NCT01960374|"~     The purpose of the study is to assess the safety, tolerability and PK of selumetinib~     (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian~     volunteers following administration of a single dose. Standard safety assessments including~     ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and~     an optional exploratory pharmacogenetics will be performed.~   "
83810|NCT01960361|"~     The current prospective clinical study's aim is to determine ABT's ICE implant survival~     rate, crestal interproximal bone resorption during 24 months post implant insertion and to~     assimilate the drilling sequence during the clinical use of ICE implants.~   "
83811|NCT01960348|"~     The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in~     patients with transthyretin (TTR) mediated amyloidosis~   "
83812|NCT01960335|"~     Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity~     epidemic. Increased dietary protein is one effective strategy. For example, increased whey~     protein ingestion with and without exercise training is associated with enhanced weight~     loss, body composition and subjective hunger in overweight and obese individuals. Our~     findings suggest that the effects of whey protein ingestion occur independent of a~     calorie-restricted diet and to a greater extent in individuals following a combined exercise~     program of resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic~     exercise training compared to standard resistance training.~   "
83813|NCT01960322|"~     The specific aim is to pilot-test our developed intervention manual's ability to improve~     patients' adherence to medications and medical outcomes (rejection rate, liver enzyme~     levels) in participating centers.~   "
83814|NCT01960309|"~     This is a cross-sectional pilot study to assess coronary artery disease with minimal~     invasive techniques in patients with asymptomatic troponin elevation after noncardiac~     surgery. The primary objective is to quantify coronary artery disease, as determined by~     coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective~     is to correlate coronary calciumscore to postoperative levels of troponin.~   "
83815|NCT01960296|"~     Patients who on taking clopidogrel are randomized to either continue clopidogrel into~     general surgery or discontinue clopidogrel 7 days before surgery. All patients resume~     clopidogrel after surgery. The investigators track the development of bleeding complications~     that may develop within 90 days of the surgery. Patients are medically cleared to be in~     either arm of the study by their cardiologist and surgeon. There is currently no evidence to~     support for or against the use continuation or discontinuation of clopidogrel prior to~     general surgery.~   "
83816|NCT01960283|"~     Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not~     found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment~     consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic~     alternatives exist. Methotrexate, which is not expensive and often prescribed by~     dermatologists, has been efficiently tried in an open study on severe chronic idiopathic~     urticaria, and also in few case reports.~   "
83817|NCT01960270|"~     Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with~     low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for~     overactive bladder. However, in the medium or long term, some patients failed to benefit~     from unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could~     be tested then implanted to restore the efficacy. An other option is to perform a bilateral~     stimulation of the sacral nerves that could lead to a summation effects better than~     unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a~     contralateral or a bilateral test should be considered.~   "
83818|NCT01960257|"~     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),~     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect~     information about patients taking their TB medications. The wearable sensor records~     information, which is uploaded wirelessly to a mobile device and then to a secure computer.~     Together the sensors and the mobile device transmitting the information to the study~     computer are called a digital health feedback system (DHFS), which gives healthcare~     providers information about when patients have taken their TB medications. The advantage of~     the DHFS is that patients can take their medication where and when it is convenient for~     them, and do not have to wait for a nurse to directly observe them taking their medication.~      The purpose of this study is to find out if using these new technologies works as well as~     the standard method of observing in person when patients take their TB medications. This~     study will also look at the costs of using a DHFS for TB medications, what patients and~     healthcare providers think about using it, and other factors that can determine when one~     approach works better than another.~      This study has two parts. For the first part of the study (Step I), patients will have an~     initial screening visit and then, in one two-week period, they will have 4 study visits at~     the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services~     (PHS) workers. This part of the study is designed to confirm that the DHFS is working~     correctly and is accurately collecting information about each dose of medication that~     patients take, and to understand what patients and healthcare providers think about using~     the DHFS.~      If patients are eligible for the second part of the study (Step II) and want to continue,~     that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the~     second part of the study, patients will be randomized into one of the following two groups.~      Group 1: TB treatment is monitored by continued use of the DHFS~      Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)~      The second part of the study is designed to compare these two methods of observing patients~     taking their TB medications, what the relative costs of these methods are , and the~     perception by patients and/or healthcare providers of the ease of use of the novel~     technology.~   "
83819|NCT01960244|"~     The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy,~     clinical outcomes, and patient-reported outcomes over time. The registry represents a~     collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical~     Research Institute, lipid specialists, cardiologists, primary care providers, quality~     improvement personnel, and patients, all aiming to increase FH awareness, promote optimal~     disease management, and improve FH outcomes.~   "
83820|NCT01960231|"~     Type 2 diabetes mellitus patients exhibit many glucose homeostasis abnormalities in~     different tissues and organs. Among the more important defects are disturbed hepatic glucose~     metabolism and defective pancreatic β-cell function. Hexokinase IV, commonly known as~     glucokinase, is the predominant hexokinase expressed in the liver, the pancreatic β-cells~     (where it functions as the glucose sensor for insulin secretion) and in glucose-sensory~     cells in the hypothalamus and gut.~      The glucokinase gene contains two distinct promoters. The downstream one is active only in~     hepatocytes and the upstream promoter is active only in extrahepatic glucose sensory-cells.~     Alternative promoters enable differential regulation of gene transcription in liver and~     extrahepatic sites. In pancreatic β-cells, glucokinase expression at the mRNA level is~     largely constitutive, whereas in the liver it undergoes large adaptive changes in response~     to nutritional states, enabling larger changes in glucokinase activity than would otherwise~     be possible by post-transcriptional regulation alone.~      Most of the MODY-2 patients were found to have glucokinase mutations located in areas that~     are common to the liver and pancreas. The diabetes in these patients is related both to~     defect in insulin secretion and abnormal hepatic glucose metabolism. Point mutation in the~     pancreatic specific promoter was recently described as a cause for impaired fasting glucose~     [Diabetes 58:1929-1935, 2009]. The investigator have recently identified a MODY-2 family~     with a genetic defect that is located in the pancreatic promoter, sparing the liver~     promoter. This family demonstrates that abnormal insulin secretion alone (perhaps together~     with other extrahepatic glucose sensors) is enough to cause diabetes.~      In this study, the investigators would like to use an oral glucose tolerance test (OGTT) and~     continuous glucose monitoring (CGM) technique in order to elucidate the relative roll of the~     hepatic glucokinase in normal glucose homeostasis. This issue is complicated by the fact~     that in addition to glucokinase, hexokinase isoenzymes I, II and III are also expressed at~     very low levels in hepatocytes. They are an important back-up mechanism when glucokinase~     activity is compromised, as in liver cirrhosis or murine models with liver-specific~     glucokinase knock-down. However, impaired hepatic glycogen synthesis was demonstrated in~     MODY-2 subjects (JCI 1996:98:1755). By comparing members of the investigators MODY-2 family~     with members of other MODY-2 families and normal controls the investigators hope to shade~     some light on this question.~   "
83821|NCT01960218|"~     To determine whether, and if so, which gas exchange parameters measured on the Shape-HF~     Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in~     subjects discharged from hospitalization for an episode of acute decompensated heart~     failure.~   "
83822|NCT01960205|"~     The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed~     people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4~     inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its~     influences on the targets of obesity related metabolic abnormalities, to explore new ways~     for intervention on populations with pre-diabetes and obesity .~   "
83823|NCT01960192|"~     The purpose of this study is to evaluate the efficacy and safety of FVD regiment~     (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.~   "
83824|NCT01960179|"~     Primary Objective:~      To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and~     52 weeks in patients with type 2 diabetes in Japan~      Secondary Objective:~      To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52~     weeks on:~        -  HbA1c (Glycated hemoglobin A1c) reduction;~        -  Fasting plasma glucose;~        -  Body weight.~   "
83825|NCT01960166|"~     The investigators proposed study will investigate the efficacy of tablet computer~     distraction as an analgesic for the pain associated with various painful procedures in the~     emergency department. Since prior studies have shown that distraction by a parent or nurse~     can be an effective analgesic, there is reason to believe that tablet computer distraction~     will similarly reduce pain. Participants in the control group will receive a cartoon on the~     TV monitor in the patient room, while participants in the study group will receive a more~     immersive distraction of playing a game or watching a cartoon (for children too young to~     play a game) on a tablet computer. Data from this study will help inform best practices for~     administering painful procedures in a way that minimizes pain.~   "
83826|NCT01960153|"~     PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary~     study is to evaluate the rate of decline in renal function and frequency of development of~     acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and~     pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.~   "
83827|NCT01960140|"~     The purposes of this study are to determine the effects of baricitinib on the time it takes~     to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib~     is when given alone and in combination with simvastatin. Side effects will be documented.~     The study will last approximately 7 days from the first dose to the end of the study (not~     including screening or follow-up).~   "
83828|NCT01960127|"~     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an~     impact on morbidity and mortality. Regular aerobic exercise training is a proven effective~     therapy to improve exercise capacity in healthy and clinical populations. The effect of this~     training has not yet been evaluated in the decompensated cirrhosis patient population. The~     safety of this intervention also requires further study. Using a randomized controlled~     design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic~     exercise training on aerobic capacity, functional performance, and muscle mass in~     decompensated cirrhosis patients.~   "
83829|NCT01960114|"~     The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg~     (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar~     extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg~     tablets) in a sub-group of subjects.~   "
83830|NCT01960101|"~     Dry mouth is in most cases due to iatrogenic causes, particularly drugs. The existing~     products such as saliva substitutes are often disappointing (bad taste, poor efficiency).~      Our hypothesis has considered the empirical observations made by some patients with~     xerostomia who consumed milk products to relieve the dry mouth syndrome from which they~     suffered. With this clinical observation, a closer collaboration has been undertaken with~     research laboratories specialising in food and especially milk. Through its composition, the~     dairy product in itself provides relief for the patient, due both to its physical and~     biochemical properties, which could explain these observed improvements, and elements~     related to the phenomena of consumption of food as an alternative to medication. In the~     latter, hedonism takes on a role which has not been previously assessed. Initial work~     undertaken with the department of applied research at the National Dairy Industry School~     (ENIL) led to the prototyping of a new natural milk, which is the subject of this~     application for development, to qualify and adapt a product with a health benefit in~     patients suffering from xerostomia.~      To further develop this project we will initiate a sequential clinical trial by groups of~     five ambulatory patients with xerostomia (patients taking antidepressants followed in~     psychiatry appointments). The clinical tests will be organised by the CIC with the~     psychiatric wards of the University Hospital of Besançon. Each group of 5 patients will test~     a similar product for 14 days. The information collected after a series of tests with a~     group of patients will be translated by changing the ENIL specifications to produce a new~     mini-series of products. This repetition will be carried out up to 3 times if necessary to~     help achieve a satisfactory product in terms of taste, texture and lubrication properties,~     which will then be tested in a randomized controlled cross-over study of the efficiency and~     acceptability of the new LactoXeros product versus a reference product (Aequasyal ®,~     Oxidized Glycerol Triester) on a group of 32 patients at the University hospital of Dijon.~      A natural way to combat xerostomia at the interface of patient diet, such as we propose,~     could help improve quality of life for patients, minimize harmful effects (infection, decay)~     and promote adherence of patients to treatments which are responsible for xerostomia.~   "
83831|NCT01960088|"~     The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines,~     including human papillomavirus (HPV) vaccine. In the first part of the study, we will~     characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in~     a national survey. In the second part of the study, we will provide HPV vaccines and other~     vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community~     pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems~     and workflow needed to provide vaccines effectively and safely, characterize parents' and~     their adolescents' attitudes toward receiving vaccine services in a pharmacy, and~     characterize pharmacists' attitudes toward providing adolescent vaccine services in a~     pharmacy.~   "
83832|NCT01960075|"~     The primary objective is to determine the most effective and/or the least effective~     treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2~     years. There are three active treatment arms being compared: fosphenytoin~     (FOS),levetiracetam (LEV), and valproic acid (VPA).~      The second objective is comparison of three drugs with respect to secondary outcomes.~      The final objective is to ensure that the trial is informative for treatment of established~     SE in children by describing the effectiveness, safety, and rate of adverse reactions of~     these drugs in children.~   "
83833|NCT01960062|"~     Between October 1 and November 30, 2011, participants will be enrolled in this study~     comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with~     HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32~     people (16 per group) will participate in the study. Once eligible patients are found, they~     will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care~     with the CPS plus web-based care using the MyLink software. Participants using the software~     will agree to upload their glucometer measurements using the software every 2- 4 weeks.~     Following the receipt of the glucometer data, either electronically from intervention group~     participants or verbally from the control group participants, medications/ doses will be~     adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups~     will receive a follow-up HbA1c 2-4 months after enrollment to see if there were any~     significant changes in HbA1c between groups.~   "
83834|NCT01960049|"~     Abdominal wall incisions used for liver surgeries are associated with significant~     postoperative pain and disability. Epidural analgesia is often contraindicated in these~     patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and~     opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW)~     catheters can be placed during surgical closure along the incision line and can be used to~     administer local anesthetics for postoperative pain. The study is a multi-centre,~     double-blind, randomized controlled trial involving 120 patients undergoing elective liver~     surgery. Patients will be randomly assigned to AW catheter group treated with drug or~     control treated with saline. Treatment group will receive AW catheters with ropivacaine plus~     standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline~     and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for~     pain scores, side-effects, chronic pain and complications.~   "
83846|NCT01959893|"~     Fibromyalgia Syndrome (FMS) is a highly prevalent condition, often affecting individuals at~     the prime of life, causing severe reduction of quality of life and productivity, as well as~     social isolation, anxiety and depression.~      FMS is a condition characterized by chronic widespread pain, considered to be a~     manifestation of central nervous system sensitization, leading to increased processing and~     transmission of pain. At the same time however, it has become gradually more evident, that~     FMS is not merely a pain syndrome. Those patients who suffer from the full-blown clinical~     syndrome of FMS inevitably describe many additional symptoms beside pain. While some of~     these symptoms, such as heightened sensitivity to external stimulations (e.g. noise and~     light), can easily be understood as representing aspects of the basic underlying propensity~     towards central sensitization, other symptoms are not so easily explained in this context.~   "
83835|NCT01960036|"~     The long-term objective of this study is to improve women's substance use disorder (SUD)~     treatment. The immediate project goal is to test the efficacy of an innovative mind-body~     intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use~     relapse among women in SUD treatment.~      A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body~     psycho-education approaches of interoceptive training and mindfulness to develop~     somatically-based self-care skills and to facilitate emotion regulation. A three-group,~     randomized clinical trial using repeated measures, this project will enroll and randomize~     225 women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75),~     and Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study~     conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.~      The primary aim is to test the hypothesis that MABT will result in reduced substance use and~     related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second~     aim is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two~     diverse community treatment facilities, serving racially diverse patients, will be recruited~     for study participation. This study builds on promising preliminary evidence of MABT~     feasibility and acceptability in substance use disorder treatment for women, and addresses~     the need for more clinical research aimed at improving SUD treatment outcomes for women.~   "
83836|NCT01960023|"~     The FC-7 study is designed as an open label, single arm, Phase I/II dose-escalation study~     evaluating the combination of neratinib and cetuximab in patients with metastatic colorectal~     cancer primary tumor that is quadruple wild-type  (wild-type KRAS, NRAS, BRAF, PIK3CA).~     The primary aim in the Phase I portion of this study is to determine the safety and~     tolerability of the two-drug combination. The primary aim of the Phase II part is to~     determine the overall objective response rate (complete and partial responses) by Response~     Evaluation Criteria in Solid Tumors (RECIST 1.1).~      Patients will receive concurrent therapy with cetuximab (400 mg/m2 IV loading dose followed~     by 250 mg/m2 IV weekly), and neratinib.~   "
83837|NCT01960010|"~     The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution~     compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.~   "
83838|NCT01959997|"~     The objective of this study is to compare the elimination of atrial fibrillation in patients~     with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when~     undergoing repeat PVI (control) vs repeat PVI plus renal denervation.~   "
83839|NCT01959984|"~     The object of this study is to compare 100g Standard Noodles  with traditional~     carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the~     diagnosis of diabetes mellitus.~      In this study, we will compare the different effects of 100g Standard Noodles Tolerance~     Testand 75g Oral Glucose Tolerance Teston plasma glucose, insulin, c- peptide level and~     the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides,~     in part of the subjects, the difference between 100g Steamed Bread Tolerance Test, 100g~     Standard Noodles Tolerance Test and 75g Oral Glucose Tolerance Test will be further~     evaluated.~   "
83840|NCT01959971|"~     Primary Objective:~      To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured~     by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein~     (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).~      Secondary Objectives:~      To assess the effects of SC doses of alirocumab on:~        -  Various parameters of the metabolism and turnover in plasma of different lipoproteins~        -  Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol~          (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB,~          lipoprotein(a) (Lp(a))~        -  Lipoprotein particle size profile~        -  PCSK9 (free and total) concentrations in serum To assess safety and tolerability of~          alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum~          alirocumab concentrations.~   "
83841|NCT01959958|"~     Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal~     enuresis (bedwetting) compared to the general population. This increased risk has been~     attributed to a decreased ability to concentrate urine caused by sickling-induced~     nephropathy. The sociodemographic, psychosocial, and medical factors associated with~     nocturnal enuresis are not well defined. In addition, the impact of these behaviors on~     emotional and behavioral functioning, along with health-related quality of life are not~     clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very~     few families with a child with sickle cell disease have utilized these methods. The reasons~     for this underutilization of interventions are not clear.~   "
83842|NCT01959945|"~     Flublok was studied previously in children 6 -59 months of age and demonstrated less than~     satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the~     initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric~     population will evaluate immunogenicity and safety older children and adolescents, aged~     6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity~     of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results~     in this study may support further studies in younger children.~   "
83843|NCT01959932|"~     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating~     System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the~     levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful~     constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence~     (SA).~   "
83844|NCT01959919|"~     This study aims to investigate prospectively throughout a period of 3- 6 months and not to~     exceed 12 months (according to local therapeutic plans) patients experiences of treatment~     with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII~     compared to their previous delivery system.~   "
83845|NCT01959906|"~     A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of~     the CRM, is still controversial. The aim of this study was to compare the clinical~     significance of a suspicious CRM to histologically positive (R1) and negative margin (R0)~     resections in patients with pT3 esophageal and GE-Junction tumors.~   "
83894|NCT01959269|"~     The purpose of the study is to investigate the safety and effectiveness of Stivarga in~     patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely~     observational, only data from routine treatment are to be collected. The treatment and~     treatment conditions are solely at discretion of the treating physician.~   "
83852|NCT01959815|"~     Patients with scleroderma can develop heart failure due to high blood pressure in the lungs~     (a condition called pulmonary arterial hypertension). It is important to find pulmonary~     arterial hypertension early, so that it can be treated before heart failure develops.~     However, the tests that we now use to find the earliest form of this disease in scleroderma~     patients are not good enough. This study will examine whether tests performed during~     exercise can improve our ability to find early pulmonary arterial hypertension. The study~     will also try to identify genes that are responsible for the development of pulmonary~     arterial hypertension.~   "
83853|NCT01959802|"~     Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after~     surgery for macular pseudohole~   "
83854|NCT01959789|"~     The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2~     days after the first bleaching session without increasing the bleaching-induced tooth~     sensitivity~   "
83855|NCT01959776|"~     Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after~     macular hole surgery~   "
83856|NCT01959763|"~     This intervention aims to reduce obesity by using new type of nutritional and lifestyle~     therapy and in parallel, tailored persuasive information and communications technology~     (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced~     just by distributing nutritional information. Instead, by influencing also the eating~     behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the~     time-line, the health information literacy of the study persons and the changes in it will~     be studied at different phases of the intervention. The research will be carried out in~     three groups of different nutritional therapies with a parallel ICT-intervention group for~     each.~   "
83857|NCT01959750|"~     ICU caregivers face up to a demanding job with a high level of technical skills, a stressful~     environment, and a heavy work load. They run a high risk of developing burnout that can~     impact on their welfare, performance, and patient care. Burnout favours absenteeism and~     staff quitting their jobs, whereas the shortage of ICU caregivers already started. No~     randomised controlled intervention aimed at reducing such distresses had been run until now.~      This study allowed finding a new method of psychological support applicable in the special~     environment of ICU. Our findings suggest that psychologists specifically assigned to treat~     ICU caregivers might be beneficial on their burnout.~   "
83858|NCT01959737|"~     The first hours after birth are a sensitive period for promotion of optimal~     mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are~     high in the first hours after birth due to high oxytocin levels. Developing optimal~     mother-child-interaction is more difficult for preterm mothers because mother and child are~     separated after birth and the preterm infant is not able to show strong signs to promote~     maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and~     their mothers for 60 minutes within the first hours after birth improves~     mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity~     of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant~     with or without SSC after birth.~   "
83859|NCT01959724|"~     Evaluation of clinical characteristics and surgical outcome for macular detachment~     associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.~   "
83860|NCT01959711|"~     Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal~     tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic~     adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of~     the posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many~     surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief~     is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the~     LTLA as minimally invasive approach to small and benign adrenal tumors.~   "
83861|NCT01959698|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works~     in treating patients with stage I-IV diffuse large B-cell lymphoma that has returned~     (relapsed) or that has not responded to treatment (refractory). Carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, may block cancer growth in different ways by targeting~     certain cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide,~     also work in different ways to stop the growth of cancer cells, either by killing the cells,~     by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with~     rituximab, ifosfamide, carboplatin, and etoposide may be a better treatment for diffuse~     large B-cell lymphoma.~   "
83862|NCT01959685|"~     To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in~     healthy adult male subjects as the dose to be investigated in a thorough QT~     interval/corrected QT interval (QT/QTc) study.~   "
83863|NCT01959672|"~     This phase II trial studies how well combination chemotherapy with or without oregovomab~     followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in~     treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as oregovomab, can block tumor growth by targeting certain cells.~     Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells~     more sensitive to radiation therapy. Giving combination chemotherapy with or without~     oregovomab followed by SBRT and nelfinavir mesylate may kill more tumor cells.~   "
83864|NCT01959659|"~     This non-interventional, cross-sectional survey and retrospective review will evaluate the~     medical resource utilization and burden of illness in patients who have persistent symptoms~     of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not~     had an acute exacerbation in the 3 months prior to enrolment. Medical records will be~     reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection~     at a single visit will include rating scales and questionnaires that reflect the clinical~     status and the quality of life of the patients and the economic impact of schizophrenia.~   "
83865|NCT01959646|"~     This is a nutritional intervention study using healthy overweight/obese humans to~     investigate if a supplement made from aged garlic extract has an impact on immunity.~     Following a baseline blood draw, participants will consume the capsules (garlic or placebo)~     for 42 days, at which time a second blood draw will occur. Tests for immune function and~     inflammation will be performed on both the baseline and 42 day samples. The investigators~     anticipate that the immune functions and biomarkers that are inflammatory in an~     overweight/obese population will be returning to normal after 42 days of consumption of this~     supplement. The investigators predict that AGE supplementation will benefit immunity and~     improve function while reducing inflammation in a stressed population (inflamed obese).~   "
83866|NCT01959633|"~     The hypothesis of this study is to evaluate the safety and the efficacy of~     Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment.~   "
83867|NCT01959620|"~     The overall aim of this study is to determine the optimal dose, 3-session exposure~     intervention versus 1-session exposure intervention compared to no treatment, for the~     delivery of exposure therapy in the immediate aftermath of trauma for preventing the~     development of posttraumatic stress disorder.~   "
83868|NCT01959607|"~     The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the~     amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK~     profiles from a single use of a conventional cigarette (CC) and from a single use of~     nicotine gum in a Japanese population.~   "
83869|NCT01959594|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in~     healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days~   "
83870|NCT01959581|"~     The purpose of this study is to assess: 1) how infants move their bodies to explore, play,~     and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these~     abilities can be advanced in a high-risk group through the use of a movement assisting~     device.~   "
83871|NCT01959568|"~     Purpose: to assess the efficacy and safety of double tamponade versus silicone oil~     tamponade.~      Design: parallel-group study with balanced [1:1] stratified block randomization. Eligible~     participants are all adults aged 18 or over with first diagnosed rhegmatogenous total~     retinal detachment with retinal breaks located both in upper and lower retina. Also~     investigators include those patients with total retinal detachment with proliferative~     vitreoretinopathy (PVR) in which it is impossible to remove epiretinal membranes completely~     during the surgery (with arbitrary retinal breaks localization). Exclusion criteria are~     severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas~     etc) and eye length more than 27mm.~      Patients are randomized in two groups (test group and control group).~      In the test group patients undergo subtotal vitrectomy, epiretinal membrane removal,~     perfluorodecalin (PFD) tamponade, retinal photocoagulation. After that the surgeon replaces~     ½ of PFD volume by conventional SO (with density less than one of water). The result is~     vitreous cavity (VC) filled in a half with PFD and in another half - with SO. In the control~     group patients undergo subtotal vitrectomy, epiretinal membrane removal, PFD tamponade,~     retinal photocoagulation and PFD-SO exchange, so the result is VC filled with conventional~     or heavy SO, depending on predominant retinal breaks location. 30 days after the surgery in~     both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride~     gas (SF6) which dissolves during 1 month. Follow-up is at least 12 months.~      Along with standard examinations, after SF6 gas dissolution investigators perform spectral~     optical coherence tomography (OCT) and microperimetry. With OCT investigators measure~     thickness of retinal inner and outer nuclear layers. With microperimetry investigators~     determine light sensitivity in 12° and 4° zones from the fixation point.~      Outcome measures: reattachment rate, best corrected visual acuity (BCVA), intraocular~     pressure (IOP), thicknesses of inner and outer nuclear layers according to the OCT, light~     sensitivity according to microperimetry, the rate of cataract formation in phakic eyes and~     the rate of tamponing agents emulsification.~      For final analysis each group will include 145 participants.~      OCT, microperimetry data and visual acuity will be compared between the groups using~     Student's t-test; proportions will be compared using exact Fisher's test.~   "
83872|NCT01959555|"~     This study is conducted in Europe. The aim of the study is to update the knowledge about the~     prevalence and severity of congenital haemophilia (A and B) in Spain.~   "
83873|NCT01959542|"~     In this research study, the investigators are trying to determine if there are measurable~     changes in prostate MRI that will help predict those who will or will not respond to~     Androgen Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first~     baseline prostate MRI prior to the start of treatment is standard of care. The participant's~     ADT/EBRT treatment is also standard of care, as advised by their doctor. It is the 3 follow~     up prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part~     of this research study.~   "
83874|NCT01959529|"~     This trial is conducted globally. The aim of this trial is to compare cardiovascular safety~     of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of~     cardiovascular events.~   "
83875|NCT01959516|"~     This study purpose is to further study the profiles of glycopyrronium (NVA237) and~     tiotropium during the first hours after dosing and their impact on pulmonary function, COPD~     symptoms and ability to perform daily activities by the patient.~   "
83876|NCT01959503|"~     This study is being conducted to evaluate the safety and effectiveness of the Progel~     Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by~     mechanically sealing areas of leakage.~   "
83877|NCT01959490|"~     This phase II trial studies how well trastuzumab and pertuzumab or bevacizumab with~     combination chemotherapy works in treating patients with stage II-III breast cancer.~     Monoclonal antibodies, such as trastuzumab, pertuzumab, and bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumors to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as docetaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide,~     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving trastuzumab and pertuzumab or a~     commercially marketed formulation of bevacizumab without modification with combination~     chemotherapy may kill more tumor cells.~   "
83878|NCT01959477|"~     This clinical trial studies personalized dose monitoring of busulfan and combination~     chemotherapy in treating patients with Hodgkin or non-Hodgkin lymphoma undergoing stem cell~     transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer~     cells by stopping them from dividing or killing them. After treatment, stem cells are~     collected from the patient's peripheral blood or bone marrow and stored. The stem cells are~     then returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy. Monitoring the dose of busulfan may help doctors deliver the most accurate~     dose and reduce toxicity in patients undergoing stem cell transplant.~   "
83941|NCT01958645|"~     A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after~     single ascending doses in healthy male.~   "
83881|NCT01959438|"~     In vitro studies have demonstrated that sodium selenite in sufficient concentration and~     during sufficient time have a high tumoricidal capacity. This is found in many human cell~     types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of~     cell lines seem to be resistant. The question from a clinical point of view is: Is it~     possible with respect to toxicity to administer sodium selenite to patients in sufficient~     dose and during sufficient time to get responses in patients with cancer? We have performed~     first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions~     during 12 days. We have recorded limited anti-tumor effect in this treatment regimen.~     However, in vitro data suggest that low concentration of continuous exposure for 51 h is~     much more effective. Now we are planning to continue the phase-I trial with modified~     protocol.~      More specific:~        1. Phase I: Find maximal tolerable dose with continuous infusion~        2. Phase II: Use MTD and study responses, if any~   "
83882|NCT01959425|"~     The objective of this study is to determine the safety of discontinuing oral anticoagulation~     therapy in high risk patients who have had a successful cardiac ablation and remain AF~     recurrence free for 3 months post ablation.~   "
83883|NCT01959412|"~     The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and~     27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.~   "
83884|NCT01959399|"~     The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the~     pharmacokinetics of rosuvastatin in healthy adult male and female subjects.~   "
83885|NCT01959386|"~     This observational study will evaluate the efficacy, safety, tolerability and patient~     reported quality of life of Herceptin (trastuzumab) subcutaneous therapy in patients with~     HER2-positive early breast cancer in routine clinical practice. Data from eligible patients~     will be collected for the duration of their treatment (approximately 1 year) and for 1-2~     years of follow-up.~   "
83886|NCT01959373|"~     Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both~     upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not~     always easy to establish. The only technique used in routine to assess the corticospinal~     dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is~     largely dependent on LMN state and is based on artificial motor cortex activation.~      The main objective of our study project is to evaluate a new method assessing functional~     changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical~     coherences, it could be possible to show modifications in both cortico-muscular relationship~     and in cortical activity coordination which could be related to clinical state in ALS~     patients. We notably expect a decrease in cortico-muscular coherence in ALS patients.~     Furthermore, these analyses could provide new insights in motor system plasticity phenomena.~     We expect a partial covering of voluntary motor command by cortical areas adjacent to~     primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor~     control may be assumed by ipsilateral corticospinal tract could be tested by coherence~     analyses.~      Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This~     method has the advantage to be painless and not to use artificial stimulations as it is used~     in TMS.~   "
83887|NCT01959360|"~     The aim of the present study is to explore the most efficient surgical approach in total hip~     replacement in short and long term when concerning strength, functionality and postoperative~     complications.~      The objective is to register muscular strength, hip joint functionality/mobilisation and~     complications after total hip arthroplasty (THA) performed by two minimal invasive/incision~     surgeries (MIS) versus the traditionally lateral approach.~      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the~     muscles, patients will tolerate early hospital discharge better after MIS than after~     traditional lateral surgery. Patients in the MIS group will also be more active and maintain~     muscular strength and hip joint functionality/mobilisation better than patients in the~     lateral group.~   "
83888|NCT01959347|"~     The overarching goal of this randomized trial is to estimate the effect of combined~     midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared~     to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives~     include estimating the effect of combined treatment compared to MUS on improving overactive~     bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional~     treatment, time to failure and identifying predictors of poor outcomes in this MUI~     population.~      A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and~     vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.~   "
83889|NCT01959334|"~     In recent past years, regulatory agencies such as FDA and EMA have outlined and recommended~     adoption of a risk-based approach to evaluating and mitigating immune responses to~     therapeutic proteins that may adversely affect their safety and efficacy. In their~     recommendations, both transient and persistent antibody responses should be combined to~     determine the overall immunogenicity of a product in a given condition. In particular,~     persistent antibodies are of high importance, since patients with persistent antibodies are~     more likely to experience clinical sequelae in terms of safety and efficacy, while a~     transient antibody response can resolve without further consequence.~      The present study will provide information on immunogenicity of AMG504-1 with regards to the~     potential development of high antibody titers or neutralizing antibody activity which may~     lead to loss of efficacy or an increased risk of an adverse reaction.~   "
83890|NCT01959321|"~     This multi-center observational study examines risk factors for HCV transmission from mother~     to baby.~   "
83891|NCT01959308|"~     Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and~     reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to~     graft rejection is a well-recognized event. This study aims to study the differences in~     patient compliance to immunosuppressive treatments and patient preference.~   "
83892|NCT01959295|"~     To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.~   "
83893|NCT01959282|"~     The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with~     moderately to severely active ulcerative colitis (UC).~   "
83942|NCT01958632|"~     The actual study should provide a first direct comparison between results after~     reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard~     methods of nerve transplantation and direct nerve suture.~   "
83895|NCT01959256|"~     This study will test the hypothesis whether visual field defect caused by chronic stroke~     could be improved by visual perceptual learning. The secondary hypothesis is that~     improvement of visual field defect would be accompanied by connectivity changes in visual~     networks. In addition, investigators will evaluate whether improvement of visual field~     defect could achieve improvement of subjective visual function.~   "
83896|NCT01959243|"~     To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025%~     versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51%~     of subjects will be 40 years of age or older.~   "
83897|NCT01959230|"~     To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with~     its vehicle for treating ocular redness in a population of adult and geriatric participants~     with ocular redness.~   "
83898|NCT01959217|"~     Medication adherence rates among youth living with HIV are inadequate to effectively manage~     the disease, and novel interventions grounded in basic behavioral sciences are needed. This~     multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding~     prospective memory (PM) into a more potent adherence intervention for youth living with HIV~     (YLH).~      The phases are:~      Phase 1: To improve PM in basic laboratory tasks in YLH with and with out substance abuse.~        -  Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding,~          self-monitoring and cue salience) will improve PM within each participant.~      Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking~     ART in YLH with suboptimal adherence.~        -  Hypothesis 2: Using a multiple baseline across subjects design, adherence to ART will~          improve following initiation of the PM adherence intervention and will be maintained~          for 6 weeks after tapering of the intervention.~        -  Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will~          be seen in youth with and without substance problems.~      Phase 3: To conduct a pilot randomized clinical trial of the PM intervention compared to~     traditional text message reminders (comparison condition) in non-adherent youth stratified~     by substance use.~        -  Hypothesis 3: Youth randomized to receive the PM intervention will show greater initial~          and sustained improvements in adherence and viral load compared to those randomized to~          the control condition.~        -  Hypothesis 3a: We will explore trends in the data relative to substance abuse, but we~          anticipate that the intervention will show promise for both substance using and non~          substance using YLH warranting a larger clinical trial that can test for~          substance-related mediators and moderators of the intervention.~   "
83899|NCT01959204|"~     The objective of this study is to characterize the pharmacokinetics and to evaluate the~     safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent~     subjects for postoperative pain.~   "
83900|NCT01959191|"~     Objective: To evaluate the early and late prognoses of patients according to platelet~     reactivity after clopidogrel administration and determine whether the measurement of~     platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass~     (OPCAB) Study design~        -  Prospective, observational, single-center study~        -  Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be~          enrolled.~        -  Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be~          measured by VerifyNow system.~        -  Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1~          year after surgery and subjects will be followed-up for 1 year about primary endpoint.~        -  Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and~          the cohort will be divided by the PRU cutoff value (low/high platelet reactivity~          groups).~        -  The primary and secondary endpoints will be compared between two groups~   "
83901|NCT01959165|"~     This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase~     II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with~     moderate to severe UC~   "
83902|NCT01959152|"~     The purpose of this study is to determine the feasibility of preserving low-frequency~     acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and~     severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the~     HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.~   "
83903|NCT01959139|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination~     chemotherapy and to see how well they work compared with combination chemotherapy alone in~     treating patients with newly diagnosed pancreatic cancer that has spread to other places in~     the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better~     by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as~     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination chemotherapy is more effective with or without pegylated recombinant human~     hyaluronidase in treating pancreatic cancer.~   "
83904|NCT01959126|"~     The purpose of this research study is to examine whether a stress reduction intervention can~     improve health, mood and biological markers of cellular stress and aging in a group of~     chronically-stressed maternal caregivers and healthy maternal controls.~   "
83905|NCT01959113|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective antimicrobial Staphylococcal species such as~     Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides~     that play a role in protecting the skin from invading pathogens. In this study, the~     investigator will attempt to decrease S. aureus colonization and increase colonization by~     protective Staph species in AD patients. First the investigator will capture the bacteria on~     subjects' lesional AD skin. Next the investigator will selectively grow the subject's~     antimicrobial Staphylococcal colonies and place them into a base moisturizer. The~     moisturizer plus bacteria will be applied to one of the subject's arms, and the moisturizer~     alone (without bacteria) to the other arm. The investigator will then do a quantitative wash~     of the bacteria growing on each arm one day later in order to determine whether the S.~     aureus abundance was affected by the application of the transplanted bacteria.~   "
83943|NCT01958619|"~     A healthy volunteer study to characterise the exposure of the two study medications,~     following administration of OZ439 + TPGS granules with piperaquine phosphate granules~     (intended for children) and with piperaquine phosphate tablets (intended for adults).~     Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.~   "
83944|NCT01958606|"~     The objective of this study was to compare the effectiveness of high intensity interval~     training (HIT) and traditional aerobic training for persons with stroke.~   "
83906|NCT01959100|"~     The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic~     stem cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host~     disease (GVHD) that is associated with significant mortality and morbidity. The reported~     incidence of SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed~     within 2 years after transplantation. The diagnosis of SBO relies on the occurrence of a new~     airflow obstruction identified during pulmonary function testing, and the definition differs~     between studies. Currently, no curative immunosuppressive treatment is available, and recent~     data suggest that the use of these treatments, especially corticosteroids, should be limited~     because of their toxicity. The impairment of lung function parameters is likely caused by~     fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are~     available. Several hypotheses are based on the occurrence of SBO during chronic graft~     rejection after lung transplantation, which shares many clinical and histopathological~     similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading~     to SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only~     one clearly identified risk factor: extrathoracic chronic GVHD. Due to their~     anti-inflammatory and immunomodulatory properties, recent data suggest that low-dose~     macrolides may be effective at preventing SBO after lung transplants. This well-tolerated~     treatment may be useful for preventing SBO after allogeneic HSCT.~      The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to~     evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in~     patients with malignant hematological diseases.~   "
83907|NCT01959087|"~     This study aims to compare the results of colonic surgery performed by single and multiport~     laparoscopy.~   "
83908|NCT01959074|"~     This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral~     stent after urinary stone surgery.~   "
83909|NCT01959061|"~     To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer~   "
83910|NCT01959048|"~     Clostridium difficile has become one of the leading causes of hospital acquired infections,~     and is associated with increased mortality. Patients with C. difficile associated disease~     (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result~     of earlier antibiotic usage. The current standard of care treatment for severe C. difficile,~     which consists of antibiotics, does not restore the microbiota. Restoration of the normal~     colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic~     microbial population to a more 'normal'state and lead to cure.~      A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic~     megacolon. The management in this context is based on limited data, and for some the only~     available option is sub-total colectomy.~      Although FMT is by no means a new therapeutic modality, there is limited information on its~     use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity~     and mortality associated with treatment of patients with severe CDAD, and because the~     evidence supporting the current recommendations is weak and based upon the demonstration~     that FMT is an effective strategy to re-establish a balanced intestinal microbiota with~     resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for~     severe CDAD.~      Patients with severe CDAD can be divided into two operational groups; those that have~     diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through~     colonoscopy for all patients because current data suggest that the overall success rate of~     FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the~     upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic~     megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality),~     intra-colonic FMT administration is the preferred alternative.~   "
83911|NCT01959035|"~     To obtain information on the safety, tolerability and effectiveness of aripiprazole~     once-monthly in a manner consistent with its intended use in everyday clinical practice in~     patients with schizophrenia who completed Study 14724A / NCT01795547.~   "
83912|NCT01959022|"~     This study will assess the effects of the medication doxazosin on sleep in men and women~     with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and~     wrist actigraphy.~   "
83913|NCT01959009|"~     Background:~      Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency~     oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure~     fluctuation around a continuous distending pressure and therefore small tidal volume. Animal~     studies showed that recruitment and maintenance of functional residual capacity (FRC) during~     HFOV (open lung concept) could reduce lung injury.~      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using~     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with~     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at~     a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable~     oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung~     recruitment. This has however to our knowledge not been tested in a clinical trial using~     modern ventilators.~      Purpose, aims:~        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in~          oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as~          percentage time with oxygen saturation outside the reference range.~        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist~          planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh.~      Methods:~      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will~     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4~     alternating 1-hours periods (2-treatment, double crossover design, each patient being its~     own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise~     HFOV will remain at pretrial settings. Outcome will be calculated from normal clinical~     parameters including pulx-oximetry and transcutaneous monitoring of oxygen and~     carbon-dioxide partial pressures.~   "
83914|NCT01958996|"~     R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's~     lymphoma. In order to avoid central venous system insertion and reduce hospitalization time~     in elderly patients, we developed an oral chemotherapy treatment:  OROCIEPtrial.~      Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities.~     The estimated two-years overall survival was 74%. The main haematological toxicity was~     neutropenia.~      This study is still ongoing to confirm recommended dose of oral anthracycline.~   "
83915|NCT01958983|"~     The purpose of this study is to determine if the effects of music therapy alter emotion and~     cognition performances of individuals with mild to moderate dementia. The music therapy~     intervention protocol is structured by drum improvisation, rhythm imitation, music cognition~     and song discussion. Attentive listening and active participation of the music training~     activities allow participants to utilize their focus of attention and comprehension of~     informational texts. Music therapy intervention is proposed to provide positive stimulations~     on emotion and cognitive functions of individuals with dementia. The results of the present~     study will clarify relationship between the effect of music therapy and the neural substrate~     of music therapy in anatomical and functional brain data obtained from MRI (fMRI).~   "
83916|NCT01958970|"~     This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745~     or placebo in treating protein energy wasting (PEW) in patients receiving maintenance~     hemodialysis (MHD).~   "
83917|NCT01958957|"~     The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the~     treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.~   "
83918|NCT01958944|"~     Cystic Fibrosis is defined as a genetic disorder affecting approximately 100,000 individuals~     worldwide. CF is caused by mutations in the CF Transmembrane Conductance Regulator (CFTR)~     gene. CF patients are highly prone to environmental opportunistic bacterial infections~     leading to prolonged and chronic lung infections. This results in reduction in the life~     expectancy of CF patients due to excessive lung tissue destruction.~      Nitric Oxide (NO) is a naturally produced antimicrobial agent which is part of the innate~     immune defense system of the lung. Both in vitro and in vivo studies had shown clearly that~     NO acts against a wide variety of microbes including drug resistant bacteria as well as~     viruses and fungi. Building on a successful phase I safety trial, the team aims to develop a~     combined drug-device strategy to combat lung infections caused by biofilm-forming bacteria.~     Unlike other inhaled drugs, NO is also a smooth muscle relaxant and avoids the concomitant~     bronchial constriction often associated with inhaled antibiotics. An added benefit of NO~     therapy is its mucolytic activity. We suggest that the combine broad spectrum antimicrobial~     activity, signaling and mucolytic properties of NO, delivered to the lungs of CF patients,~     will be directed at reducing bacterial resistance, microbial burden and biofilms as well as~     resulting in improved airway clearance of viscid sputum.~      Primary Objectives: Assess the safety and the tolerability of NO intermittent inhalation~     treatment in ≥10 years old CF subjects. Secondary Objective: Assess the improvement in~     forced expiratory volume in 1 second (FEV1) before and after NO intermittent inhalation. Up~     to 10 subjects with Cystic Fibrosis will be enrolled into the study.~      Treatment administration: The subjects will receive intermittent inhalation of NO in~     addition to standard treatment for 10 working days (no NO treatment will be given to the~     subjects during weekend days). The subjects will be asked to attend the CF clinic once a~     week for a period of two weeks in order to evaluate the parameters related to the study.~     Oxygen (O2), NO, nitrogen dioxide (NO2) and fraction of inspired oxygen (FiO2) delivered to~     the patient will be continuously monitored.~   "
83919|NCT01958931|"~     A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the~     diagnosis of lung cancer.~   "
83920|NCT01958918|"~     This is a 12-month, phase IV, randomized, open label, multicenter study to compare efficacy~     of 0.5 mg ranibizumab pro re nata treatment versus 2 mg aflibercept bimonthly intravitreal~     injections on central retinal thickness (CRT) stability as measured by mean CRT fluctuations~     between month 3 and month 6 of treatment by spectral domain optical coherence tomography~     (SD-OCT) and explore functional outcomes up to month 12 in patients with neovascular (wet)~     age-related macular degeneration (AMD). Approximately 500 patients will be randomized in~     Europe.~   "
83921|NCT01958905|"~     The general objective of the study is to answer to the question: Is the current dose of AL~     less efficacious in the severely malnourished compared to the non-severely malnourished~     children, and is PK in cause? We aim to assess whether the current treatment dose is~     adequate for children with severe acute malnutrition, and we hope results will guide further~     recommendations for malaria treatment in this specific population.~   "
83922|NCT01958892|"~     The purpose of the study is to assess whether transurethral enucleation of prostate gives~     better or equivalent outcomes compared to the gold standard of transurethral resection of~     the prostate~   "
83923|NCT01958879|"~     The study aims to evaluate effectiveness of ringer injection with or without corticosteroid~     during arthrocentesis of the temporomandibular joint in the treatment of internal~     derangement of the temporomandibular joint (TMJ).~   "
83924|NCT01958866|"~     Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.~      This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product~     compared with the acetaminophen. Total of 96 patients with body temperature between~     37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be~     randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr,~     Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third~     group will receive placebo twice daily.~   "
83925|NCT01958853|"~     The purpose of this open label study is to provide up to 24 active treatments of noninvasive~     cortical electrostimulation therapy only to those fibromyalgia patients who experienced~     inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201~     (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol~     as that used in active treatment arms of NPT-201. The study's primary outcome measure will~     be the patient's change from baseline in self-reported 24-hour average pain intensity. The~     study will provide active treatment to those participants who received sham therapy in~     NPT-201, and will test whether or not additional therapy applications might further improve~     pain in those participants who previously received active therapy, but did not achieve~     adequate pain relief.~   "
83926|NCT01958840|"~     Following a small, open-label pilot study that yielded very promising results of BATD, the~     current study will consist of a larger, randomized control trial (n=60) that will compare~     BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement~     in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In~     addition, participants' adherence rates to each of the therapies and their maintenance of~     clinical gains at a 1-month follow-up, will be examined.~   "
83927|NCT01958827|"~     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after~     dose escalation in Japanese subjects with Crohn's Disease.~   "
83928|NCT01958814|"~     randomized double-blind controlled study in parallel groups~      Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.~      During this administration, non invasive ventilation for the patient will be continued.~   "
83929|NCT01958801|"~     The aim of this study is to compare the efficacy of supraclavicular and interscalene~     brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.~   "
83954|NCT01958476|"~     1: SPECIFIC AIM I: To compare treatment options for neonatal abstinence syndrome (NAS) due~     to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of~     NAS requiring medications will be studied. Infants will be randomized to receive either~     morphine or methadone. It is hypothesized that morphine treated infants will do better and~     require fewer days in the hospital compared to methadone treated infants.~      2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental~     outcome. Infants will be evaluated with development testing at 18 months of age. It is~     hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It~     is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will~     correlate with neurodevelopmental impairment at 18 months.~      3: SPECIFIC AIM III: To determine if common genetic variations in the genes involving~     narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all~     infants and analyzed for differences in 3 key genes. This will then be correlated with~     short-term and long-term outcomes.~   "
83930|NCT01958788|"~     Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and~     uncontrollable worry. Our research group has developed a cognitive-behavioural treatment~     (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that~     arises from a set of negative beliefs about uncertainty and its consequences (Dugas &~     Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous~     clinical trials: approximately 70% of participants fully remit from GAD following treatment~     and maintain these gains over extended follow-up periods. These results, while positive, do~     suggest that a substantial minority of individuals do not fully benefit from the existing~     treatment protocol. Across our randomized clinical trials, individuals who do not achieve~     diagnostic remission of GAD continue to endorse elevated levels of intolerance of~     uncertainty. This suggests that the current CBT protocol does not effectively reduce~     intolerance of uncertainty in some treated individuals. To address this, we have developed a~     modified version of the original CBT protocol that targets intolerance of uncertainty more~     directly. The goal of the current proposal is to determine whether this newly developed CBT~     protocol with fewer components can deliver comparable or superior GAD symptom reduction. A~     total of 7 participants with a primary diagnosis of GAD received the newly developed CBT~     protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance~     of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and~     6-month follow-ups. The proposed study will provide information about the efficacy of this~     new CBT protocol in reducing GAD symptoms.~   "
83931|NCT01958775|"~     1. To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study~          A)~        2. To assess whether GLP-2 affects the release of preformed chylomicrons (study B)~   "
83932|NCT01958762|"~     In the Somme region of France, cancer registry data showed an increasing incidence of oral~     cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity~     and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for~     male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve~     early detection for smokers will be assessed. This target population consults late (as 70%~     of oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an~     innovative incentive strategy for screening among general practitioners based on unusual~     information vectors (tobacconist, local media).~      The main objective of this study is a screening of oral cavity cancers in tobacco users aged~     30-75 years in the Somme region of France.~   "
83933|NCT01958749|"~     The current standard treatment for chronic tympanic membrane perforations (TMP) involves~     having fat grafted from the patient and inserted into the ear, through the perforation, to~     promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma~     (PRP) has also been used to promote TMP healing and involves having the patient provide a~     blood sample, which is processed to produce PRP and applied to the perforation. This~     prospective, multi-centre study will evaluate whether combining both these techniques can~     improve the rate of closure in patients with chronic TMP involving <50% of the membrane.~      Patients will be randomized to receive either the standard FGM treatment or FGM treatment~     with the addition of PRP. At 3 months postintervention a blinded observer will rate the~     degree of TMP closure. Differences in closure rates between the 2 groups will be compared.~   "
83934|NCT01958736|"~     This pilot study intends to evaluate whether stroke patients can complete ballistic strength~     exercises for thirty minutes, three times per week over a six week training period in~     addition to their existing rehabilitation program.~      It will evaluate whether using ballistic training principles, is superior in improving~     mobility compared with usual care exercises to improve mobility and leg strength in stroke~     patients.~      In this study there will be 15 participants per group, a total of 30 participants. The~     control group will receive usual care consistent with existing rehabilitation practice and~     literature. The experimental group will perform task specific strength training in a~     ballistic fashion.~   "
83935|NCT01958723|"~     The emergence of electronic documentation has led to multiple new challenges for physicians.~     Despite positive expectations, many physicians have received electronic health systems with~     mixed results. Review of current literature has identified the following reasons for~     concern: increased time required for documentation, deteriorating quality of notes, mindless~     use of copy-and-paste functions, and fragmentation of clinical work from poorly designed~     computing workflows. The study of template use has not been done in a large scale or with~     clear outcome measurements. The purpose of this study is to examine the effects of Problem~     Specific Templates on quality, accuracy, and efficiency of physician documentation~     practices.~   "
83936|NCT01958710|"~     Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.~   "
83937|NCT01958697|"~     Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body~     Mass Index (BMI) values are age-independent and the same for both sexes. From the~     perspective that these two parameters should actually be taken into account too, we~     developed a model to calculate age-gender specific BMI-percentiles (AG-BMI) and tested~     this model in relation to survival outcome after esophagectomy for cancer.~   "
83938|NCT01958684|"~     To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to~     Cu-IUD over the first 6 months.~   "
83939|NCT01958671|"~     This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the~     treatment of subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control~     on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week~     placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase~     B). The primary hypothesis of the trial is that at Week 26, the mean reduction from baseline~     in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo.~   "
83940|NCT01958658|"~     This phase I trial studies the side effects and best dose of WEE1 inhibitor MK-1775~     (AZD1775) when given together with cisplatin and radiation therapy in treating patients with~     cervical cancer. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high~     energy x-rays to kill tumor cells. Giving WEE1 inhibitor MK-1775 together with cisplatin and~     radiation therapy may be a better treatment for patients with cervical cancer.~   "
83945|NCT01958593|"~     This small (pilot) study is designed to provide information on whether the combination of~     psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress~     disorder (PTSD). The researchers will use the results of this study to design more studies~     of this treatment. The study compares a comparator and a full dose. For each session, there~     will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of~     the initial dose. The study will measure symptoms of PTSD, depression, general psychological~     well-being, sleep quality, feelings that the self or world is unreal (dissociation),~     potentially positive effects of surviving traumatic events and cognitive function (thinking,~     memory and attention). People experiencing pain or tinnitus (ringing in the ears) will~     record their symptoms throughout the study. Seven people will be randomly (by chance)~     assigned to receive full-dose MDMA and five will be randomly assigned to receive a~     comparator. There will be three preparatory psychotherapy sessions before the first~     experimental session, and subjects will have supportive or integrative sessions after each~     MDMA-assisted psychotherapy session. Subjects will meet with a male and female~     psychotherapist for all experimental sessions and for sessions before and after each~     experimental session. Subjects who received comparator can enroll in Stage 2, where they~     will have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know~     they are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have~     a third experimental session.. Symptoms of PTSD and other symptoms will be measured again at~     least 12 months after each subject has started the study.~   "
83946|NCT01958580|"~     This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation~     therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them~     from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving~     combination chemotherapy with radiation therapy may kill any tumor cells that remain after~     surgery.~   "
83947|NCT01958567|"~     The main purpose of this study is to describe the optical coherence tomography (OCT)~     findings in eyes with scleral inflammation and to differentiate cases with anterior~     scleritis from those with episcleritis and normal controls.~   "
83948|NCT01958554|"~     Intimate partner violence (IPV) against women have negative mental health consequences for~     survivors; interventions designed to improve survivors' depressive symptoms and health~     status are limited.Present study evaluate the effectiveness of an integrated intervention in~     reducing intimate partner violence (IPV) improving health status.~   "
83949|NCT01958541|"~     This study investigates the impact of brief behavioral insomnia treatment on depressive~     symptoms among military veterans.~   "
83950|NCT01958528|"~     This is a prospective study to collect blood and bone marrow samples from patients with SM~     and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed~     for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to~     detect patients at high risk of progression to multiple myeloma in patients with MGUS and~     SMM.~   "
83951|NCT01958515|"~     The primary purpose of this research is to investigate anti-tumor immune responses in~     patients undergoing chemotherapy and radiation for Head and Neck Cancers.~      Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in~     changes in the tumor microenvironment. We hypothesize that these changes during daily~     fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune~     responses.~      Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy~     in the presence or absence of lymphopenia.~        -  This study will determine whether specific anti-tumor immune responses (Specific~          Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation~          treatment for Head and Neck Cancers.~        -  This study will evaluate the presence or absence of HPV (human papillomavirus) specific~          immune responses before, during, and after treatment for Head and Neck Cancers.~        -  This study will also evaluate whether decreased white blood cell counts may affect~          development of immune responses in Head and Neck cancer patients undergoing treatment.~      Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you~     are older than 18 years of age, capable of providing informed consent, have a life~     expectancy of greater than 4 months, and have a good performance status.~      You are eligible irregardless of your HPV positive or negative status. People with HPV~     positive (human papillomavirus associated) head and neck cancer may join. People with HPV~     negative head and neck cancer may also join.~   "
83952|NCT01958502|"~     Because the rate of non union of long bone in lower extremities specially in tibia in this~     two last decade due to malnutrition and smoking and other risk factors was increased, so~     many patient in our country suffer from non union. On the other hand it seems that the use~     of the mesenchymal stem cells can irritate the union rate. Also for better result we used~     the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a~     osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this~     combination is useful in filling the gap in non union site and irritate the union rate.~      Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure.~     Then the investigators will follow the patient with monthly radiography and evaluate the~     callus volume and clinical union and any side effect of this treatment. Clinical union~     consider to relief pain in non union site and be stable in examination.~   "
83953|NCT01958489|"~     The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels~     in the blood when both drugs are taken at the same time. The study will also assess how well~     the body handles evacetrapib and pravastatin when given at the same time.~      This study has two periods in fixed order. Each participant will enroll in both periods.~     This study will last approximately 25 days, not including screening.~   "
83955|NCT01958463|"~     Recent data have demonstrated beneficial health outcomes of microbiota transplantation for~     the treatment of Clostridium Difficile infection.~      The investigators propose testing whether fecal transplantation from a healthy donor can~     lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.~   "
83956|NCT01958450|"~     Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode~     laser treatment.~   "
83957|NCT01958437|"~     Remembering how to travel from one location to another is critical in everyday life, yet~     this vital ability declines with normal aging and can be further affected by conditions that~     disproportionately affect the elderly, such as vision loss or progressive dementia. Human~     and animal research has shown that two distinct memory systems interact during navigation.~     The first, referred to as allocentric navigation, is very flexible and uses spatial~     knowledge of key features or landmarks to develop and use a mental map of the environment.~     This approach involves brain regions that are critical for new learning and memory but that~     decline with age. The second, referred to as egocentric navigation, is inflexible and relies~     on habit memories that link specific features with specific directions. This approach~     relies on brain regions that are critical for automatic responses and that are relatively~     unaffected by age.~      The main problem is that allocentric navigation declines with age and is accompanied~     increased dependence on egocentric navigation. This change increases the risk of becoming~     disoriented or lost when traveling in unfamiliar areas or even when traveling new routes~     in familiar areas. Therefore, the main goal of this project is to examine whether~     non-invasive brain stimulation, specifically transcranial direct current stimulation, can~     improve allocentric navigation in healthy older adults and patients with mild cognitive~     impairment.~      Participants will complete two functional magnetic resonance imaging sessions while learning~     new environments. Before one of these sessions, participants will receive active brain~     stimulation over the parietal cortex. Before the other session, participants will receive~     sham brain stimulation over the parietal cortex. The effects of this stimulation will be~     evaluated using both an allocentric and an egocentric memory test. Physiologic effects will~     be evaluated using both task-based and resting-state MRI.~   "
83958|NCT01958424|"~     The purpose of this study is to examine the effect of metabolic syndrome in over-weight~     women on IVF treatment outcomes.~   "
83959|NCT01958411|"~     -  Vascular inflammation is a key factor in both the pathogenesis and outcome of~          atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a~          promising tool for identifying and quantifying vascular inflammation within~          atherosclerotic plaques.~        -  Non-alcoholic fatty liver disease (NAFLD) is closely associated with many~          cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation~          using computed tomography (CT).~        -  Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT)~          is an independent marker of cardiovascular events in the general population.~        -  Therefore, the purpose of this investigators study is to compare the NAFLD severity and~          EAT volume with FDG uptake measured by PET/CT.~   "
83960|NCT01958398|"~     Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll~     and PartyPlanner among university government members at two universities in Stockholm,~     Sweden. The design is a three-armed randomized controlled design, and outcomes are measured~     in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation~     and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time~     registration of alcohol consumption and giving feedback of estimated blood alcohol~     concentration levels. Both apps inform and warn the user when the estimated alcohol level is~     above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally~     provides the possibility of simulating and planning an alcohol consumption event in advance~     and later on comparing it with the real time registration at the event.~      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are~     randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner~     and 3. Control group. Outcomes on alcohol use as well as information on the users'~     satisfaction with the app assigned to them gathered after 7 weeks.~      The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions~     will reduce their alcohol use to a larger extent than the control group at follow-up~     compared to the baseline level. 2. The addition of the possibility to plan events beforehand~     (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time~     use (Promillekoll).~   "
83961|NCT01958385|"~     This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled~     study intended to evaluate the safety and efficacy of treating obese patients with the~     placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as~     compared to a sham procedure followed by the same diet and exercise plan. Subjects will be~     randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or~     the sham procedure followed by diet and exercise. After un-blinding at 12 months~     post-treatment, sham patients can choose to have the treatment procedure as well.~   "
83962|NCT01958372|"~     This phase I trial studies the side effects of soy isoflavones when given together with~     radiation therapy and chemotherapy in treating patients with stage IIIA-IIIB non-small cell~     lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, pemetrexed sodium, and etoposide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Soy isoflavones may help radiation therapy, cisplatin, pemetrexed sodium, and~     etoposide work better by making tumor cells more sensitive to the drug. Soy isoflavones may~     also protect normal cells from the side effects of radiation therapy and chemotherapy.~   "
83963|NCT01958359|"~     Objectives: The study evaluates the efficacy of two automated telephony, also known as,~     Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short~     IVR works as an interactive alcohol diary where the user is contacted once a week for four~     weeks to register their alcohol consumption during the preceding week. The user is given~     feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR~     contacts the user once a week for four weeks and is also available for user-initiated calls~     24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu~     where the user chooses among listening to vignettes and doing exercises with the purpose of~     looking at alcohol consumption and exploring ways of coping with it.~      Method: The design is a three-armed randomized controlled design, and outcomes are measured~     in terms of changes in problematic alcohol use at follow up six months after study~     initiation and baseline data gathering. Participants with problematic alcohol use (AUDIT >7~     for men and >5 for women) are randomized into one of three groups: 1. Short IVR, 2.~     Therapeutic IVR and 3. Control group. Outcomes on alcohol use as well as information on the~     users' satisfaction with the intervention are assessed after 6 months.~      The primary hypothesis for this study is that having access to one of the two IVR~     interventions will lead to a greater reduction of problematic alcohol use compared to~     controls who undergo only screening and follow-up assessment. The secondary hypothesis is~     that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in~     risky drinking.~   "
84058|NCT01957111|"~     Individuals with insomnia have been shown to have higher overall metabolic rates compared to~     good sleepers, but it is not known which metabolic processes are involved. The goal of this~     study is to compare a wide array of metabolic processes in 15 people with insomnia and 15~     good sleepers. We hypothesize that there will be distinct metabolic processes that are~     functioning differently in those with insomnia.~   "
83964|NCT01958346|"~     We propose the additional technique of lingual traction or tongue pulling in conjunction~     with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts~     at and decreasing time to intubation of the difficult airway and rescuing otherwise failed~     intubation attempts. Induction of general anesthesia causes relaxation and approximation of~     the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating~     unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual~     traction can assist in diminishing these problems by clearing the tongue away from the soft~     palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially~     in the unanticipated difficult airway patient.~   "
83965|NCT01958333|"~     The purpose of this study is to investigate the effects of three different exercise programs~     (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on~     health-related physical fitness, biochemical variables and general health outcomes in~     high-risk employees, with about 2000 volunteers will participate in the randomized and~     repeated-measure study.~   "
83966|NCT01958320|"~     The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA)~     treatment approaches: 1) an early treatment approach or 2) a conservative approach. For~     the purposes of the study infants will be enrolled if they are delivered before 28 weeks~     gestation and have a moderate/large PDA present at 5-7 days after birth.~      The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease~     the time needed for assisted respiratory support, diuretic therapy, and gavage feeding~     assistance, in addition to decreasing the incidence of ductus ligations or need for future~     outpatient cardiology follow-up appointments. The investigators hypothesize that one or more~     of these benefits will occur without an increase in the time taken to achieve full enteral~     feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal~     perforations (SIP).The investigators will be comparing the effectiveness of early~     pharmacologic treatment with a control group of conservatively managed infants who will only~     receive treatment if they meet specific criteria for rescue treatment.~   "
83967|NCT01958307|"~     Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal~     state of Germany, targeting maternal and fetal health. The objective of this trial is to~     evaluate the efficacy of a lifestyle intervention program focusing on diet, physical~     activity and weight monitoring during pregnancy. The intervention comprises 4 individual~     counseling sessions addressing healthy living. Primary outcome: gestational weight gain.~     Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and~     rate of caesarean sections as well as offspring health.~      The lifestyle intervention program is adapted to the German health care system to allow an~     immediate implementation after successful evaluation.~   "
83968|NCT01958294|"~     The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System~     (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects~     who are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study~     in which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will~     be followed immediately post-op and at 30 days.~   "
83969|NCT01958281|"~     This study will evaluate the safety, tolerability and antiviral efficacy of sofosbuvir (SOF)~     with ribavirin (RBV) in participants with GT 1 and 3 and ledipasvir (LDV)/SOF in~     participants with genotype 1 and 4 HCV infection who have chronic renal insufficiency~     (impaired kidney function).~      Approximately 35 subjects with severe renal insufficiency (not on dialysis) will be enrolled~     in 3 cohorts.~        -  Cohort 1 (GT 1 or 3): 10 subjects will receive SOF 200 mg + RBV 200 mg once daily for~          24 weeks.~        -  Cohort 2 (GT 1 or 3): Following review of safety, efficacy and pharmacokinetics (PK)~          data through post-treatment Week 4 of Cohort 1, 10 additional subjects will receive SOF~          400 mg + RBV 200 mg once daily for 24 weeks.~        -  Cohort 3 (GT 1 or 4): Following review of safety and available PK data through Week 12~          of Cohort 2, 15 additional subjects will receive LDV/SOF 90/400 mg once daily for 12~          weeks.~   "
83970|NCT01958268|"~     Establishment of a questionnaire in German to determine in a structured and quantifiable~     manner the quality of life of patients with dysphagia.~   "
83971|NCT01958255|"~     The aim of this project was to provide tobacco cessation services to the women at the~     community level at their door steps and thus establish a model community based tobacco~     cessation programme which could be replicated in other communities and could be taken up by~     National Tobacco Control Programme (NTCP), in future.~   "
83972|NCT01958242|"~     Blood transfusions after pediatric heart surgery is a relatively common practice occurring~     in up to 46% of patients, however its use has been associated with increased morbidity. In~     the pediatric population undergoing heart surgery transfusion of homologous blood is usually~     required due to the mismatch between the priming volume of the cardiopulmonary bypass~     circuit and the patients own blood volume. Several strategies have been proposed in order to~     minimize the use of blood products. The effect of pre-operative harvest of fresh whole blood~     in the adult population has shown a beneficial platelet protective effect, however concerns~     have been risen that the amount of volume needed in order to sequester a significant amount~     of platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood~     harvesting has not been evaluated in the pediatric population.~      The purpose of the present study would be to evaluate the safety and efficacy of~     pre-operative blood harvesting in the pediatric population undergoing open heart surgery.~     Fresh whole blood will be harvested from the patient prior to the initiation of~     cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB~     prior to the administration of prominent. Parameters that will be evaluated will include,~     patient characteristic, operative and post-operative parameters, coagulation profiles and~     the use of postoperative blood products.~   "
83973|NCT01958229|"~     This study is designed to support the optimal use of telbivudine by providing data to refine~     our understanding of telbivudine efficacy and resistance in real life clinical setting in~     patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR~     negativity.~   "
84059|NCT01957098|"~     The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a~     sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring~     postprandial blood glucose and insulin, and selected intestinal hormonal responses to~     increasing doses of L-arabinose and D-xylose.~   "
83974|NCT01958216|"~     So far, the liver has been the main target for cholesterol elimination. However, several~     recent studies performed in mice have described a new route of cholesterol excretion, the~     Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma~     cholesterol in the feces directly via the intestine. Until now, only indirect evidence~     suggests that TICE is also active in humans, the goal of this proof of concept study is to~     provide the first proof of its existence in humans by using stable isotopes in patients with~     bile duct diversion.~   "
83975|NCT01958203|"~     Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary~     United Arab Emirates (UAE) hospital~      Study Site: Al Qassimi Hospital, United Arab Emirates~      Study Objectives:~      The primary objective of this study is assessment of appropriateness of VTE prophylaxis~     administered to critically ill and surgical patients for whom pharmacologic treatment is~     indicated according to the American College of Chest Physicians (ACCP) 2012 guidelines.~      The secondary objective is to:~      1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such~     as prescribing problems and errors at the level of administration.~      Study Design: Cross sectional retrospective observational study~      Sample size: Approximately 400~      Study Population:~      Inclusion criteria~      Patients who meet the following criteria will be included:~        1. Patients aged 18 and above.~        2. Patients admitted to any of the critical care units, or the general or orthopaedic~          surgical wards.~        3. Patients who have been in hospital more than 24 hours.~        4. Caprini score > 1 (see procedure)~      Exclusion criteria~      Patients with any of the following criteria will be excluded:~        1. Patients who have been admitted to a critical care unit and transferred out to a non~          surgical unit within 24 hours of admission.~        2. Patients receiving oral anticoagulant therapy for indications other than VTE~          prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.~      Study Outcome Measurements:~      The main outcome measure of interest is to determine the proportion of patients who have~     received inappropriate or inadequate VTE prophylaxis considering their calculated risk~     factor compared to the recommended prophylactic measures for that risk.~      Secondary outcome measures are to identify whether there is inadequate VTE prophylaxis~     because of medication errors such as missed doses or wrong doses given.~      Study Duration: 4 months~      Statistical Analysis Data was entered into Microsoft Excel® and subsequently checked to~     ensure accurate data entry and correct any errors. It was subsequently exported into SPSS~     version 20 where it will be analysed.Quantitative data such as age was expressed mean (±~     standard deviation). Categorical data such as gender, risk factors for bleeding, type of~     mechanical and pharmacologic prophylaxis, missed doses and wrong doses were expressed as~     number and percentage of population.The student's t-test was used to analyse parametric~     data. The Pearson Chi-Square Test and Wilcoxon Rank sum test were used to analyse non~     parametric data. Simple and multiple logistic regression analysis was done to identify~     factors that are associated with inappropriate VTE prophylaxis. Factors that were included~     in the analysis included: age, type of admission (medical or surgical), area of admission~     (critical care, general surgery, orthopaedic surgery), Caprini score, and inappropriate VTE~     prophylaxis as the outcome. A p-value of less than 0.05 was be considered statistically~     significant.~   "
83976|NCT01958190|"~     In this study we compare long term renal function in liver transplantation recipients~     treated with standard dose extended-release tacrolimus alone and recipients treated with a~     combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis~     is that the patients treated with the combination have better long term renal function than~     the patients treated with standard dose tacrolimus alone.~   "
83977|NCT01958177|"~     Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many~     diseases and presents with symptoms of an inability to coordinate balance, gait, extremity~     and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria,~     dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with~     movements on the same side of the body as the lesion (ipsilaterally).~   "
83978|NCT01958164|"~     This is a multicentre, open-label, randomised, phase III study designed to evaluate the~     efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD~   "
83979|NCT01958151|"~     Colonoscopy is an outpatient procedure performed frequently as a screening test for~     diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as~     an invasive procedure with the potential for embarrassment, discomfort, and worry. Such~     fears can result in anxiety that may decrease the tolerance and cooperation of the patient,~     limit the success of the procedure, and increase the likelihood of complications. Therefore,~     colonoscopy is frequently performed under sedation. The anxiety level of the patient before~     the procedure may increase the requirement for sedation. It is important for the~     anesthesiologist to predict the effective dosages of sedation before the procedure to ensure~     rapid and comfortable sedation as well as prompt recovery and discharge of the patient.~      This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety~     level on the dose of propofol needed for patient and surgeon satisfaction during~     colonoscopy.~   "
83980|NCT01958138|"~     The study will be done in pediatric population by comparing two techniques of Laryngeal Mask~     Airway (LMA) removal under the deep anesthesia.~      The both study techniques will be compared on the basis of smooth Laryngeal Mask Airway~     removal, emergence time and the duration of recovery room stay.~   "
83981|NCT01958125|"~     The study will look at a non-invasive treatment for people suffering with chronic and~     episodic headaches. Study subjects will be randomized to an active treatment or an in-active~     treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active~     treatment for an additional 2 weeks.~   "
83982|NCT01958112|"~     This research study is evaluating the combination of two drugs called GSK1120212~     (trametinib) and GSK2141795 as a possible treatment for recurrent or persistent cervical~     cancer. Trametinib and GSK2141795 are drugs that may stop cancer cells from growing.~     Trametinib is a MEK inhibitor - it blocks a protein called MEK that is commonly overactive~     in tumor cells. GSK2141795 is an AKT inhibitor which blocks a pathway in cancer cells that~     is commonly overactive in tumor cells called the PI3kinase pathway. In this research study,~     the investigator is looking to see whether the combination of Trametinib and GSK2141795 is~     useful in treating recurrent and persistent cervical cancer.~      Additionally, the investigator is looking to see if participants whose tumors contain a~     particular genetic make-up will have better response to combination trametinib and~     GSK2141795. Participants' tumors will be tested for mutations in genes which could make some~     cancers more susceptible to trametinib and GSK2141795.~   "
83983|NCT01958099|"~     The purpose of this project is to compare the costs, ability to effectively screen and~     distribute relevant safety information, and assess products purchased and behavior changed~     by families after meeting with an injury prevention specialist compared to using a~     computerized emergency department kiosk. There will be a significantly greater reported~     practice of safety behaviors by families who visit a pediatric emergency department after~     using a computerized kiosk for injury screening and providing tailored recommendations than~     when the prevention information is provided by an injury prevention specialist.~   "
84169|NCT01955668|"~     In Part A to investigate the safety and tolerability of AZD6738 when given orally to~     patients with relapsed/refractory CLL, PLL or B cell lymphoma.~      In Part B to investigate the safety and tolerability of AZD6738 when given orally to~     patients with prospectively identified 11q deleted or ATM deficient, relapsed/refractory CLL~   "
84170|NCT01955655|"~     This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their~     treatment.~   "
83984|NCT01958086|"~     The investigators objective is to run human clinical trials in which brain activity recorded~     through a brain-chip implanted in the human brain can be used to provide novel~     communication capabilities to severely paralyzed individuals by allowing direct~     brain-control of a computer interface. A prospective, longitudinal, single-arm early~     feasibility study will be used to examine the safety and effectiveness of using a neural~     communication system to control a simple computer interface and a tablet computer. Initial~     brain control training will occur in simplified computer environments, however, the ultimate~     objective of the clinical trial is to allow the human patient autonomous control over the~     Google Android tablet operating system. Tablet computers offer a balance of ease of use and~     functionality that should facilitate fusion with the BMI. The tablet interface could~     potentially allow the patient population to make a phone call, manage personal finances,~     watch movies, paint pictures, play videogames, program applications, and interact with a~     variety of smart devices such as televisions, kitchen appliances, and perhaps in time,~     devices such as robotic limbs and smart cars. Brain control of tablet computers has the~     potential to greatly improve the quality of life of severely paralyzed individuals. Two~     subjects will be enrolled, each implanted with the NCS for a period of 53 weeks. The study~     is expected to take two years in total.~   "
83985|NCT01958073|"~     The investigators would like to know if the use of vaginally applied estrogen can prevent~     the problem of repeated urinary tract infections (UTI) in women who have gone through~     menopause. The investigators will use two forms of vaginal estrogen that are available by~     prescription (a ring and a cream) and compare their efficacy to that of a placebo (without~     any active ingredient). The investigators are going to look at if the vaginal estrogen can~     prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month~     period. After 6 months, all subjects will receive vaginal estrogen and the women on the~     non-active treatment will be randomized to either the estrogen ring or cream. The~     investigators will then be able to compare the number of UTIs on and off active vaginal~     estrogen treatment within those subjects who started on the placebo. The investigators are~     also going to look at quality of life before and during treatment using questionnaires and~     whether subjects stop using the treatments or do not use them as directed (compliance).~   "
83986|NCT01958060|"~     Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following~     intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of~     the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and~     determination of the bioavailability of subcutaneous injections of BI 1034020~   "
83987|NCT01958047|"~     This study investigates how ASP3652 is taken up, broken down, and distributed through the~     body and excreted in individuals of different races. The study also investigates levels of~     biochemical markers in the bloodstream, and determines how safe the study drug is and how~     well it is tolerated after dosing. A further aim is to look at how the processes of~     metabolism, distribution and excretion of the study drug are possibly altered by the daily~     diet of the volunteers taking part.~   "
83988|NCT01958034|"~     In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment~     elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial~     infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a~     range of parameters with prognostic importance in cardiovascular disease: lipids,~     inflammation, oxidative stress and heart function.~      Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to~     bilberry placebo powder we have amended to the protocoll that the trial design is changed~     from blinded to open and that the bilberry arm of the trial carries on in an open design and~     that the control group will receive no dietary supplement.~   "
83989|NCT01958021|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial.~   "
83990|NCT01958008|"~     The main objective of the current trial is to investigate safety, tolerability and~     pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.~   "
83991|NCT01957995|"~     This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel~     lipid suspension in treating patients with advanced solid tumors. Drugs used in~     chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~   "
83992|NCT01957969|"~     The aim of this observational study is to evaluate the utilization in the clinical practice,~     effectiveness, explantation and re-intervention rate, complications and adverse events of~     InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal~     incontinence.~      This study will provide additional data about safety and effectiveness of the usage of~     InterStim system in fecal incontinence environment and at the same time will confirm that~     results from clinical trials can be transposed to clinical practice.~   "
83993|NCT01957956|"~     This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with~     newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with~     tumor proteins may help the body build an effective immune response to kill tumor cells.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     vaccine therapy and temozolomide may be an effective treatment for glioblastoma.~   "
83994|NCT01957943|"~     The study Aims to investigate the possible beneficial impact of peri-operative or~     post-operative administration of Omega 3 enriched lipid emulsions on recipients for living~     donor liver transplantation.~   "
83995|NCT01957930|"~     We aim to investigate the relationship between skin microvascular function and the first~     hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized~     during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard~     insulin treatment (ST).~   "
84005|NCT01957800|"~     A randomized controlled trial comparing the effects of the social-enabled internet weight~     loss and diet change intervention with the delayed treatment group for 3 months. We will~     study the effect of adding social interactions and supports to an Internet weight loss and~     diet change intervention. The website intervention will have action planning with social~     interactions and support features for sharing, reusing, recommending, and discussing~     strategies for improving habits. We hypothesize that the intervention group with access to~     the website will lose more weight than the delayed treatment group after three months.~   "
83996|NCT01957917|"~     The importance of good nutrition and food security among people living with HIV infection~     (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is~     increasingly recognized as an important barrier to retention in care and adherence to~     antiretroviral therapy (ART). However, there are few studies demonstrating that food and~     nutrition assistance programs can improve HIV-related outcomes. This study will address this~     gap by comparing the effectiveness of three models for short-term support for PLHIV. Food~     insecure women and men on ART will be randomized into one of three groups: 1) nutrition~     assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash~     transfers. The investigators will compare the effect of the three approaches on ART~     adherence and retention in care after 6 and 12 months of follow-up. The investigators~     hypothesize that NAC plus short-term support in the form of food or cash assistance will~     result in better adherence to ART and retention in care than NAC alone, and that the effects~     of NAC plus food assistance will be the same as NAC plus cash assistance. The results from~     the study will provide evidence about which assistance modalities for PLHIV work best to~     improve ART adherence and retention in care, and under what conditions. This study will be~     conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have~     poor or borderline food consumption and 7.4 percent of people are living with HIV infection.~   "
83997|NCT01957904|"~     The study is designed to confirm the acute safety and performance of the ArterX® Surgical~     Sealant as a hemostatic agent. The study will collect data in support of publications and~     future product labeling revisions, to provide additional clinical information on use and~     further details regarding product safety.~   "
83998|NCT01957891|"~     The purpose of the study is to assess the effect of progressive, incremental hypoxia at~     multiple wavelengths of light.~   "
83999|NCT01957878|"~     Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix~     vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell~     carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination~     with ProCervix is to activate and enhance the patient's cellular immune response to HPV .~     The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The~     vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis~     as detectable infections with oncogenic potential.~      This will be a double-blind, randomised, placebo-controlled, parallel group study assessing~     the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).~      ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites~     as a vaccine adjuvant.~      The population proposed for this study represents an otherwise healthy female population who~     are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic~     vaccine has been shown in the ongoing Phase I study, and the proposed population may in~     theory derive benefit from this vaccine.~   "
84000|NCT01957865|"~     Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The~     Wisepill Study).~   "
84001|NCT01957852|"~     Introduction~      Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive~     surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy~     (HIPEC) performed at the time of surgery. It is considered a high risk procedure and~     post-operative intra-abdominal bleeding is a major issue as it can delay recovery and~     promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second~     surgery to control the bleeding will be necessary. Major causes of bleeding are : radical~     resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.~      To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of~     these is the liberal use of FloSeal, but there is no data in this particular field of~     interest. Over the last 18 months, the investigators have started to use FloSeal in all~     their cases with large PC and they have observed a dramatic reduction in the rate of~     reoperation for bleeding and probably secondarily, in the use of blood products, but this~     has not been measured.~      Hypothesis~      FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.~      Primary objective~      To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC~     procedure in the treatment of PC.~      Secondary objectives~        -  To evaluate if the use of FloSeal can reduce operative blood loss.~        -  To evaluate if the use of FloSeal can reduce the need of blood products after CRS and~          HIPEC procedure.~        -  To evaluate if the use of FloSeal can have an impact on other common surgical~          complications (which can be indirectly bleeding related).~        -  To evaluate if the use of FloSeal can have an impact on length of hospital stay.~   "
84002|NCT01957839|"~     the investigators examined the hypothesis that hyperprolactinemia may alter uterin,~     endometrial and intraovarian blood flow and may contribute to increased infertility by~     another way.~   "
84003|NCT01957826|"~     The purpose of this study is to assess the safety, the feasibility and the efficacy of~     transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients~     with dilated idiopathic cardiomyopathy.~   "
84004|NCT01957813|"~     -Purpose: To develop and evaluate an intervention designed to improve consistent~     contraceptive use and dual method use in particular, among female sex workers (FSWs) in Rift~     Valley Province in Kenya.~      Design: A qualitative descriptive study will be conducted to develop the intervention. A~     quasi-experimental, non-randomized, two-group, pre-/post-intervention design will be used to~     evaluate the intervention.~      Study Population: FSWs living in Naivasha, Gilgil, and Nanyuki, Rift Valley Province.~      Study Duration: Phase I - 3 months Phase II - 12 months Objectives: Develop an intervention~     designed to increase contraceptive use among FSWs by incorporating formative data and~     behavioral theory and by involving the target audience and service providers in the~     development of the intervention.~      Examine the effectiveness of the intervention at increasing non-barrier modern contraceptive~     use and dual method use among FSWs.~      Assess the feasibility and acceptability of the intervention, on the parts of both the~     clients (FSW) and service providers.~      Estimate the unit cost to provide these services to one client. Study Site: Rift Valley~     Province, Kenya~   "
84006|NCT01957787|"~     The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy~     used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll~     patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less~     than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation~     procedure.~   "
84007|NCT01957774|"~     The purpose of this study is to test the experimental drug THR-18 given together with the~     drug tissue plasminogen activator for the treatment of stroke. Tissue plasminogen~     activator is also called tPA.~      Strokes often result from blockade of blood supply caused by blood clots forming within the~     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of~     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before~     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA~     when it is injected into a vein shortly after the stroke starts. However, along with~     breaking up the blood clot, tPA sometimes causes adverse effects, for example, it may cause~     bleeding. THR-18, the drug tested in this study, is meant to bind to tPA and reduce its~     adverse effects without stopping tPA's breaking up of the blocking blood clot.~      The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic~     stroke patients who are treated in parallel with tPA. Another purpose of this study is to~     investigate levels of THR-18 and tPA in the blood stream at different time points after they~     are injected, at the same time, into a vein. In addition, this study will measure tPA's~     effect on blood clot dissolution when tPA is given with and without THR-18. The study will~     also study the effect THR-18 may have on signals of brain damage that can be found in the~     blood after stroke: these signals of brain damage are small proteins called S100B and matrix~     metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain~     is injured.~      The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo~     is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be~     tested, one after the other, in three groups of patients. In each group, some patients will~     receive THR-18 and some will receive placebo. This clinical study will be conducted only at~     one hospital in the Ukraine. In total, 30 patients are planned to participate in this study.~     These patients will be in the hospital for at least 3 days after receiving the study~     treatment. Then, about 1 month later, they will be invited for a last follow-up visit.~   "
84008|NCT01957761|"~     Objectives:~        1. Describe the molecular epidemiology of Clostridium Difficile infection in children in~          the Chicago area.~        2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection~          secondary to particular endemic strains in children.~        3. Define the risk factors for recurrent and community-associated Clostridium Difficile~          infection in children.~   "
84009|NCT01957748|"~     CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate~     the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention~     in care and maintenance of ART as compared to the current standard of care (SoC) in HIV~     primary care clinics.~   "
84010|NCT01957735|"~     This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to~     examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous~     intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with~     chemotherapy (treatment Arm 2) in patients with solid tumors.~   "
84011|NCT01957722|"~     This study is to NOVOCART 3D relative to Microfracture for the treatment of knee cartilage~     defects. Efficacy will be evaluated by both pain and function. Safety will also be~     evaluated.~   "
84012|NCT01957709|"~     This pilot clinical trial studies the effect of recombinant interferon gamma on tissue in~     treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth~     of tumor cells.~   "
84013|NCT01957696|"~     Several studies have shown acceptable results after Pancreas Transplantation (PTx) by~     substituting ATG with basiliximab, which is considered to convey a considerably lower number~     of adverse events. However, our experiences with ATG in PTx (introduced in 2004) are good,~     and our presumably gentle way of administrating the drug - directed by T-cell counts - is in~     fact unique. The potential advantages of reducing the overall corticosteroid (CS) load is~     obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse~     effects.~      On this background, the investigators have very recently reduced our CS dosing (in the~     routine protocol) to a level corresponding to our Kidney Tx protocol (valid since 2009).~      Thus, the investigators intend to prospectively investigate a single PTx cohort with the~     reduced CS immunosuppressive protocol by an observational study design, and compare with~     previous (historical) cohorts, who have received high dose CS.~      Study hypotheses: i) Low-dose CS is as effective as high-dose corticosteroids with regards~     to efficacy/rejections; ii) The rate of surgical and infectious complications will be~     similar or lower in the low-dose group; iii) PTx rejection surveillance by DD~     (duodenoduodeno-stomy) and EUSPB (Endoscopic Ultra-Sound guided Pancreas Biopsies) is~     superior to traditional rejection surveillance; iv) Patient and graft survival is similar in~     the two groups~   "
84014|NCT01957683|"~     The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of~     Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction~     with embolization coils.~   "
84015|NCT01957670|"~     The study will assess the safety, tolerability and feasibility of Lacrima investigational~     medical device to treat dry eye patients~   "
84016|NCT01957657|"~     The objective of the trial is to investigate the effect of different degrees of renal~     impairment on the pharmacokinetics and safety of the combination of BI 207127 and~     faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI~     207127 and faldaprevir on day 4.~   "
84017|NCT01957644|"~     To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of~     volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS)~     or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell~     transplant~   "
84018|NCT01957631|"~     In cases of Plantar Fasciitis not responding to conservative management, minimally invasive~     techniques may be used. These include platelet rich plasma injections and corticosteroid~     injections. Corticosteroids have long been used for symptomatic relief. However there are~     growth factors present in PRP injections that contribute to the healing of the pathology,~     and not just symptom control.~      A single blind, prospective, randomized, comparative, control study will be performed. The~     study population consists of a total of 80 participants. They will be randomly assigned to~     receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be~     collected through questionnaires and ultrasound findings. Patients will have a follow up at~     3, 6, 12, and 24 weeks after they receive their injection.~   "
84045|NCT01957280|"~     The purpose of this study is to assess the PK, safety, and tolerability of patritumab~     produced by a new manufacturing process (denoted as Process 2 patritumab). The data from~     this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow~     for any dose adjustments, if needed, and to bridge data from studies previously conducted~     with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The~     hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be~     comparable to those of Process 1 patritumab.~   "
84194|NCT01955343|"~     This study is designed to evaluate the importance of the immune cells localization~     (distribution) between malignant tumor islets and surrounding stroma and to investigate the~     associations between these immune cells as well as cytokines and clinicopathological and~     prognostic factors of non-small cell lung cancer (NSCLC) patients.~   "
84019|NCT01957618|"~     Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area~     like Taiwan, where there are more than 3 million chronic hepatitis B carriers. Patients with~     chronic HBV infection are at increased risk of developing cirrhosis, which may have~     disastrous complications, including hepatic decompensation, and hepatocellular carcinoma~     (HCC). The liver cirrhosis related complications accounts for the 8th leading cause of~     deaths in Taiwan; whereas, the HCC is the 2nd leading cause of deaths among all cancers.~     Therefore, it is prudent to develop strategies to prevent or halt the progression of liver~     cirrhosis.~      For HBV patients who have already had cirrhosis, the main treatment objective is to reduce~     their risk of complications. A large-scale multicenter clinical trial showed that viral~     suppression using lamivudine in patients with advanced fibrosis effectively decreases the~     risk of HCC and liver-related complications. This study highlights the importance to treat~     HBV-related cirrhosis patients; however, several issues remain to be addressed.~      The first issue is that this clinical trial only enrolled patients with positive HBeAg or~     HBV-DNA level >1.4 x105 IU/mL. However, the current recommended threshold for cirrhotic~     patients to start anti-viral treatment is 2000 IU/mL. Whether anti-HBV therapy benefits~     cirrhotic patients in this level is still unclear. Second, lamivudine was used in this~     clinical trial; however, the high resistant rate of lamivudine during treatment probably~     lowers its protective effect against HCC. Whether a more potent anti-HBV agent with~     extremely low resistance profile, entecavir, is more beneficial to HBV-related cirrhotic~     patients is also unclear.~      The Bureau of National Health Institute launched the reimbursement program for anti-HBV~     therapy since 2003 and extended this program to cirrhotic patients with HBV DNA level > 2000~     IU/mL for long-term use since Aug, 2010. Taking this advantage, we may explore the~     above-mentioned clinical questions more easily.~      To address these issues, we will first retrospectively collect a cohort of HBV-related~     cirrhosis patients. All the patients will be enrolled from the time before oral anti-HBV~     therapy is widely used. We will determine their baseline serum HBV-DNA levels using the~     stored sera and enrolled those with baseline HBV-DNA levels higher than 2000 IU/mL as our~     historical controls. Second, we will enroll a retrospective cohort of HBV-related cirrhotic~     patients from 2008 who had HBV-DNA levels higher than 2000 IU/mL and received indefinite~     therapy of entecavir. By comparing these two cohorts, we will be able to clarify whether~     indefinite viral suppression by entecavir is beneficial for the cirrhotic patients.~      With comprehensive analysis, we wish to document that re-setting the risk level of HBV DNA~     from 140,000 IU/mL to 2,000 IU/mL is more beneficial for HBV-related cirrhotic patients and~     long-term entecavir does lower the risk of HCC further. These lines of evidence will assist~     in delivering appropriate and more aggressive treatment for these high-risk patients.~   "
84020|NCT01957605|"~     Venous return is driven by the pressure gradient between mean systemic pressure and right~     atrial pressure. However, mean systemic pressure is more a physiological concept than an~     available clinical measurement. Indeed, the mean systemic pressure is the one that would be~     measured anywhere within the vascular system after cardiac arrest. Recent advances in~     hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac~     output measurements during respiratory pauses under mechanical ventilation. In this way, it~     is possible to calculate MSP, the pressure gradient and the venous return resistances. The~     investigators aim is to explain the hemodynamic variations and the decrease in cardiac~     output observed during prone position. The investigators hypothesis is that venous return~     resistances are increased during prone position probably following an increased~     intra-abdominal pressure.~   "
84021|NCT01957592|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Sri Lanka.~   "
84022|NCT01957579|"~     The primary objective of this study is to evaluate the safety and tolerability of MEDI-551~     in Japanese patients with relapsed or refractory advanced B-cell malignancies.~   "
84023|NCT01957566|"~     The purpose of the study is to validate the diagnostic performance of the amplified~     pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in~     propofol sedated nonintubated children. To determine the sensitivity/specificity and~     positive/negative predictive value of the APS in detecting sedation-related adverse acute~     respiratory events in propofol sedated nonintubated children.~   "
84024|NCT01957553|"~     The aim of the current investigation is to investigate the performance of a new 2-piece~     ostomy product~   "
84025|NCT01957540|"~     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in~     overall mortality and thrombotic cardiovascular (CV) events when directly compared to~     clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It~     has been shown that ticagrelor increases adenosine concentration, by interfering with its~     red blood cells' uptake and by inducing the release of ATP which is then converted to~     adenosine. Recent studies in healthy volunteers and patients with coronary artery disease~     (CAD) have shown that ticagrelor increases the coronary blood flow in response to~     intravenous adenosine administration. Ticagrelor administration, in comparison with other~     P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral~     Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is~     a method for evaluating endothelial dysfunction and has been found to positively correlate~     with flow mediated dilatation (FMD).~      This is prospective, randomized study with a crossover design, which will be conducted in~     patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a~     3-month period. At Day 0 (day of randomization) eligible patients will be assigned to~     either:~        -  Ticagrelor 90mg twice a day for the next 15 days or~        -  Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment~          onset)patients wiil be subjected to a baseline peripheral arterial tonometry~          measurement. Measurement will be repeated at Day 15 and then treatment crossover will~          be performed for the next 15 days (without an intervening washout period). At Day 30~          patients will be subjected again to peripheral arterial tonometry assessment.~          Peripheral blood sample will be taken from the patients in Day 0 for genotyping~          control.~   "
84026|NCT01957527|"~     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in~     overall mortality and thrombotic cardiovascular (CV) events when directly compared to~     clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It~     has been shown that ticagrelor increases adenosine concentration, by interfering with its~     red blood cells' uptake and by inducing the release of ATP which is then converted to~     adenosine. Recent studies in healthy volunteers and patients with coronary artery disease~     (CAD) have shown that ticagrelor increases the coronary blood flow in response to~     intravenous adenosine administration. Ticagrelor administration, in comparison with other~     P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral~     Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is~     a method for evaluating endothelial dysfunction and has been found to positively correlate~     with flow mediated dilatation (FMD).~      This is a prospective, observational study, which will be conducted in patients with~     coronary artery disease subjected to percutaneous coronary intervention (PCI) under~     ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to~     completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral~     arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at~     day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from~     the patients at Day 0 for genotype analysis.~   "
84027|NCT01957514|"~     This pilot research trial studies collecting, analyzing, and storing samples from patients~     with triple negative breast cancer (breast cancer cells that do not have estrogen receptors,~     progesterone receptors, or large amounts of human epidermal growth factor receptor 2~     protein) that has spread to other places in the body receiving anti-cancer therapy. Studying~     samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients~     receiving anti-cancer therapy may help doctors learn more about changes that occur in~     deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.~   "
84028|NCT01957501|"~     Depression and bipolar disorder are major public health concerns for adolescents today.~     Teenage depression and bipolar disorder are associated with social isolation, family stress,~     school failure, substance abuse and suicide. Screening for depression and bipolar disorder~     so that treatment can be started early in the course of illness is an urgent public health~     priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar~     depression. It is critical that adolescents receive proper screening and assessment that~     leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based~     screening program could be performed on an annual or semi-annual basis to potentially detect~     depression and then differentiate between unipolar and bipolar depression. If this type of~     screening were able to detect a significant percentage of teens with depression or bipolar~     disorder, the positive impact on U.S. public health would be substantial. The purpose of~     this study is to conduct a pilot study to assess the probability of detecting adolescent~     unipolar and bipolar depression through blood samples.~   "
84029|NCT01957488|"~     The aim of the current investigation is to investigate the performance of two new 1-piece~     ostomy products~   "
84030|NCT01957475|"~     The aim of the current investigation is to develop new soft and more flexible 2-piece convex~     ostomy appliances~   "
84031|NCT01957462|"~     The aim of the current investigation is to develop new soft and more flexible 1-piece convex~     ostomy products.~   "
84032|NCT01957449|"~     To determine the safety and efficacy of administration of propranolol for reducing heart~     rate and blood pressure in burn injury.~   "
84033|NCT01957436|"~     This is a multi-center phase III study to compare the clinical benefit of androgen~     deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without~     abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.~   "
84034|NCT01957423|"~     The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein~     (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease~     patients.~   "
84035|NCT01957410|"~     To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs)~     obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect~     changes in cortical plasticity in responders to a single IV infusion of ketamine as compared~     to non-responders.~   "
84036|NCT01957397|"~     To investigate the performance and safety of the three 2-piece convex ostomy appliances~   "
84037|NCT01957384|"~     To assess the functionality and safety of the test products and also assess the products'~     ability to collect stool without interfering with the stoma. The degree of leakage using the~     product will also be measured~   "
84038|NCT01957371|"~     The primary objective of the current study is to establish the safety and acceptability of~     Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and~     chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish~     preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore~     anxiety sensitivity as a mechanism of therapeutic action.~   "
84039|NCT01957358|"~     The purpose of this study is to examine the usefulness of the Grief Recovery Method in~     assisting persons with spinal cord injuries to achieve as complete a recovery as possible,~     thereby allowing for fuller participation in life.~   "
84040|NCT01957345|"~     The primary purpose of the study is to evaluate a standardized method of screening for~     platelet signalling defects in patients with constitutional disorders of platelet function~     of unknown origin. We hypothesize that such defects are under-diagnosed in patients, due to~     heavy workup and requirement of relatively large blood sample by conventional biochemical~     methods. We propose to analyse kinase signalling downstream platelet membrane receptors~     using multiplex flow cytometry quantification and fluorescent platelet barcoding.~   "
84041|NCT01957332|"~     Current patient work-up, including conventional imaging and pathological assessment of just~     one single biopsy, might be insufficient to identify metastatic breast cancer patients, who~     possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion~     of the tumor is found quite frequently and molecular heterogeneity can occur within one~     patient, up-to-date whole body information is necessary to determine estrogen receptor (ER)~     and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently~     guide therapy decision. With molecular imaging via PET this information can be obtained in a~     non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and~     be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating~     tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular~     characterization of one metastasis at the beginning and, if feasible, of an additional~     biopsy during therapy, is necessary.~   "
84042|NCT01957319|"~     Background: Hepatitis C virus infection and interferon treatment have shown to be risk~     factors for depression, distressing, psychosocial burden and poor health-related quality of~     life.~      Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability~     and whether health related factors (anxiety and depression) were associated with work~     ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.~      Patients and Methods: In this prospective, randomized, placebo controlled, double blind~     clinical trial, 31 subjects (Group A) with chronic hepatitis, received~     Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects~     (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus~     association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12~     months. All subjects underwent laboratory exams and questionnaires to evaluate depression~     (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work~     ability (Work ability Index - WAI).~   "
84043|NCT01957306|"~     The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of~     treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO~     BID) in reducing the frequency of menopausal vasomotor symptoms among healthy,~     postmenopausal women, aged 40-65, with moderate to severe hot flushes.~   "
84044|NCT01957293|"~     Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and~     cognitive functions in healthy humans.~   "
85574|NCT01937299|"~     The purpose of this study is to demonstrate the additive effect of brinzolamide~     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or~     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy~     (TRAVATAN Z®).~   "
84046|NCT01957267|"~     The specific aims of the clinical studies are to:~        -  Improve Doppler OCT measurement of retinal blood flow.~        -  Develop quantitative OCT angiography of the ONH~        -  Measure nerve structure from ONH to retinal ganglion cells.~        -  Establish or validate age-adjusted normal reference ranges for above OCT-derived~          parameters.~        -  Establish criteria for glaucoma diagnosis based on above imaging-derived parameters.~        -  Evaluate the sensitivity and specificity of above OCT-derived parameters~        -  Measure the rate of normal age-related change in above OCT-derived parameters.~        -  Assess the reproducibility of above OCT-derived parameters.~        -  Assess abilities of above OCT-derived parameters on predicting glaucoma conversion and~          progression.~   "
84047|NCT01957254|"~     Endotoxin is the major mediator of gram-negative bacteria which cause the systemic~     inflammation and result in microcirculatory dysfunction, and it leads to multiple organ~     dysfunction and death in patients with severe sepsis and septic shock. The goal of this~     study is to measure the endotoxin activity of patients with severe sepsis and septic shock~     at certain time points, and furthermore, to compare the difference of endotoxin activity~     among different pathogens, infection source, and antibiotics. The study will enroll severe~     sepsis and septic shock patients. The endotoxin activity will be measured at certain time~     points according to the protocol.~   "
84048|NCT01957241|"~     The primary goal of this study is to quantify the biomarkers of pre-radiation therapy(RT),~     during-RT, and post-RT serum samples from hepatocellular carcinoma (HCC) and esophageal~     cancer patients undergoing definitive or neoadjuvant RT, and to correlate them with tumor~     response, patterns of failure, survival outcome, and RT-related lung or liver toxicity. The~     secondary goal of this study is to set up the PLA platform in our institute for future~     biomarker test.~   "
84049|NCT01957228|"~     On joint orthopaedic hardware infections are one of the most frequently encountered~     complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological~     diagnosis cannot be established despite obvious signs of infection. As part of this research~     project, we have developed a new strategy diagnosis including directly the use of PCR to~     reduce the number of negative results. This should have a major therapeutic impact in terms~     of timeliness and specificity of antibiotic.~      Primary:~      Evaluate the effectiveness of the new diagnostic strategy on etiological identification of~     prosthesis infections.~      Hypothesis:~      Minimum 6 percent increase in the number of patients with an etiological diagnosis of~     infection on prosthesis.~   "
84050|NCT01957215|"~     This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle~     sprain in adult patients, compared to a placebo patch~   "
84051|NCT01957202|"~     This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block~     crossover study to evaluate the effect of single and repeat doses of levocabastine, FF,~     placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected~     study duration for each individual participating in the study will be a maximum of up to 20~     weeks (including the screening and follow-up). This will be a three period study and~     subjects will be assigned to a sequence of three treatments. There will be a wash-out period~     of 14-28 days between two treatment periods. The rational for this study is to demonstrate~     proof of concept with the FDC of FF and levocabastine compared with each of the components~     administered alone.~   "
84052|NCT01957189|"~     This will be an open-label, three-period, fixed-sequence study to evaluate the drug-drug~     interaction, pharmacokinetics and safety of dutasteride and tamsulosin when administered~     alone and in-combination in Chinese healthy male volunteers.~   "
84053|NCT01957176|"~     This study will provide continued access to treatment with eltrombopag for subjects who are~     currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of~     eltrombopag (parent study) and to collect long term safety data.~   "
84054|NCT01957163|"~     After screening, subjects will enter a 4 week open-label run-in period with fluticasone~     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler~     (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium~     bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered~     once daily via a DPI; OR matching placebo administered once daily via a DPI), while~     continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period.~     There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening~     (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6)~     and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the~     last clinic visit. The total duration of subject participation in the study from Screening~     to Follow-up will be approximately 17 weeks.~   "
84055|NCT01957150|"~     This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation~     powder once daily and VI inhalation powder once daily will be evaluated in subjects with~     COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the~     inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing~     FF/VI treatment with VI treatment in subjects with moderate COPD.~   "
84056|NCT01957137|"~     The study will assess the effects of different InterStim cycling settings on urinary urge~     incontinence.~   "
84057|NCT01957124|"~     Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is~     not well established.~      We want to study the efficacy of PRF applications on the pains related to those ulcers.~      PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from~     patient's blood, without any additive nor complex manipulation. It contains blood platelets~     and white blood cells, trapped in fibrin during clot formation.~      PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does~     not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes~     are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to~     difference of density, and blood platelets and white blood cells are trapped in the fibrin~     clot.~      The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our~     hypothesis is that platelet growth factors and cytokines, liberated during platelet~     activation, could help to treat hypertensive leg ulcers, that are caused by a vascular~     spasm.~   "
84737|NCT01948245|"~     The purpose of the investigation is to compare two catheter lock solutions~     (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream~     infection, in patients with intestinal failure and a central venous access device for home~     parenteral nutrition.~   "
84060|NCT01957085|"~     The Centers for Disease Control and Prevention estimates that there are approximately 3.2~     million people in the United States infected with hepatitis C and a significant percentage~     of these patients are unaware of their diagnosis. This study will attempt to determine the~     point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All~     patients admitted to the hospital on two separate days will have hepatitis C testing done on~     leftover serum and plasma that was collected as part of routine inpatient lab work. Our~     primary goal is to determine the number of undiagnosed hepatitis C infected patients in our~     hospitalized population. We will also compare these rates to specific demographic~     characteristics, such as age, race, gender, zip code and type of insurance to see if any~     associations exist between these demographics and undiagnosed hepatitis C infection.~   "
84061|NCT01957072|"~     Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to~     become clogged with thick, sticky mucus. This leads to recurrent lung infections and reduced~     nutrients absorption from food. The average age at death is 26 years, usually from~     respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is~     important help them live healthier and longer.~      It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females.~     However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional~     support to help support weight gain. There is a clear need for a behavioural intervention~     that can help PWCF use the available nutritional support.~      This is a feasibility study to try out a multi-component behavioural intervention. The~     intervention is designed to help PWCF use their nutritional support to gain weight. It will~     focus on testing the methods and procedures to be used on a larger scale, improving the~     behavioural intervention and estimating the how many people are needed for the larger trial.~      All eligible 75 PWCF in Sheffield will be invited to participate. The investigators~     anticipate recruiting 30 participants. Participants will be divided into two groups. The~     first group receive the behavioural intervention immediately. The second group receive the~     intervention after 3 months. All participants will be followed up for 6 months. Data will be~     collected every 6 weeks during clinic reviews.~      These two groups will be compared against each other to estimate the potential impact of the~     behavioural intervention. The investigators will also interview some of the participants at~     the end of the study period to improve the intervention and the study processes based on~     participant feedback.~      The investigators hypothesised that this study will recruit around 30 participants, around~     80% of the participants will complete the study, a single full-time investigator can deliver~     the intervention to 15 participants over 3 months and data collection will be thorough (with~     less than 5% missing data). The investigators also hypothesised that this feasibility study~     will help improve the intervention and help the design of a larger trial.~   "
84062|NCT01957059|"~     The purpose of the study is to see whether BMN053 is safe and effective to use as medication~     for Duchenne muscular dystrophy (DMD) patients with a mutation around location 53 in the DNA~     for the dystrophin protein.~   "
84063|NCT01957046|"~     The main purpose of this study is to assess how effective and tolerable the country specific~     clinical practice guidelines of SLTs are for UK, France and Sweden are.~      The main rationale behind this study is that well controlled comparisons of the various~     laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which~     laxative or combination of laxatives is optimal for managing OIC.~   "
84064|NCT01957033|"~     The purpose of this pilot project is to determine the feasibility of a study design to~     investigate how many sessions of manual therapy and exercise produce the best results for~     people with whiplash injuries. Also, this study will help us determine the best way to~     measure the effect of treatment. Finally, the investigators will study how closely the~     physiotherapists follow the treatment instruction provided in the study protocol and~     training. In order to achieve these objectives, 12 people will receive manual therapy and~     exercise at one of twelve different doses. the investigators will have each of these people~     fill out questionnaires, measure sensation changes, and measure changes in the way people~     move their necks while walking. This study will help us determine if the study protocol can~     be carried out as planned. This includes: the training of all people involved in carrying~     out the assessments and treatments, the willingness and ability of participants to take part~     in all of the treatment and measures involved. This will provide us with important~     information to help us plan a larger study with 226 people with whiplash injuries.~   "
84065|NCT01957020|"~     Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy~     procedure for suspicious findings on mammograms in Western countries for more than 10 years~     [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions~     alike and was reported to feature a high sensitivity, very low delayed false-negative rate~     (less than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients~     and less morbidity compared with needle localization excisional biopsy [6,7]. However, its~     sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian~     women have different breast parenchyma pattern, different breast cancer prevalence.~     Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving~     either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an~     effective alternative to NLOC excisional biopsy in our country.~   "
84066|NCT01957007|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with docetaxel.~   "
84067|NCT01956994|"~     The hardening of the arteries observed with aging raises blood pressure and contributes to~     poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving~     problems, making decisions). Cognition is the most important determinant of overall health~     status, quality of life, functional ability and independence in older adulthood.~     Nutraceutical strategies have received considerable attention as they may improve~     cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy~     products are particularly attractive. Higher dairy consumption is associated with lower~     blood pressure and improved memory in adults. Milk proteins have natural blood pressure~     lowering effects. Studies conducted in animals have demonstrated that whey protein (a~     component of milk protein) may also increase artery elasticity. This is important given the~     strong association between artery elasticity, brain blood flow, and risk for cognitive~     decline.~      The investigators propose to conduct a randomized double-blind placebo controlled study~     comparing the effects of whey protein supplementation or carbohydrate placebo on measures of~     artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein~     may be a novel dietary therapy to improve both artery health and brain health in older~     adults.~   "
84068|NCT01956981|"~     It is very important to decrease the bleeding during functional endoscopic sinus surgery~     (FESS) in order to increase the visibility of the surgical site. Our primary goal was to~     investigate the effects of magnesium sulfate and dexmedetomidine used for controlled~     hypotension on visibility of surgical site.~   "
84738|NCT01948232|"~     The purpose of this study is to evaluate the feasibility of conducting a medical~     intervention trial in childhood cancer survivors with early echocardiographic evidence of~     cardiac remodeling.~   "
84069|NCT01956968|"~     Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These~     abnormal movements may result from a variety of flexibilty, motion or strength impairments.~     Therefore identifying any abnormal arm or scapular movement, as well as any impairments that~     are associated with them can help clinicians plan a proper management strategy for patients~     presenting with shoulder disorders. Our hypothesis is that specific impairments will be~     associated with abnormal arm movement, while other impairments will be associated with~     abnormal scapular movement among patients with shoulder pain.~   "
84070|NCT01956955|"~     Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease,~     with an approximately 30% mortality rate without treatment. Treatment is important to reduce~     mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low~     molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH),~     subcutaneous unfractionated heparin and subcutaneous fondaparinux with or without~     thrombolysis. In the treatment of acute PE, SC LMWH has been shown, at least, as effective~     and safe as IV UFH [4]. Compared to IV UFH, SC LMWH associated with lower mortality, fewer~     recurrent thrombotic events and less major bleeding. Current guidelines recommend use of SC~     LMWH for most hemodynamically stable patients with PE and they say that SC LMWH have not~     been tested in the setting of acute massive PE.~      The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the~     treatment of acute PE in combination with thrombolytic treatment.~   "
84071|NCT01956942|"~     The purpose of this study is to evaluate the effectiveness of a new laser (called Micropulse~     Laser Trabeculoplasty or MLT) in the treatment of glaucoma compared to the conventional~     laser presently used which is called selective laser trabeculoplasty or SLT. Both lasers~     (SLT and MLT) are used as standard of care in the treatment of open angle glaucoma.~   "
84072|NCT01956929|"~     This study is being done to understand metformin's mechanisms of action regarding glucose~     production, protein metabolism, and mitochondrial function.~   "
84073|NCT01956916|"~     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and~     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI~     tracts is influenced by both genetic and environmental factors. Children with CF may harbor~     an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane~     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes~     and acid suppressors). The investigators have previously demonstrated that intestinal~     inflammation is highly frequent in CF children, being a major feature of intestinal~     involvement. In addition, specific probiotics significantly improved airway and GI~     inflammation in a preliminary trial. The investigators aim to characterize intestinal and~     respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus~     GG (LGG) supplementation on both GI and airway microflora and the eventual relationship~     between probiotic assumption and clinical and inflammation markers. The investigators aim is~     to eventually improve the quality of life of CF patients, who often suffer from intestinal~     and respiratory progressive disease, through a non invasive intervention consisting in the~     supplementation of probiotic bacteria.~   "
84074|NCT01956903|"~     The purpose of this study is to determine the safety and efficacy of sequential infusion of~     allogenic mesenchymal stem cells (MSC) expanded in vitro in treating patients with acute~     graft-versus-host disease refractory to first-line therapy.~   "
84075|NCT01956890|"~     This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in~     differentiating benign nature from malignancy for lesions with suspicious or ambiguous~     findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase~     the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which~     (18F-FLT PET or MRI) reveals the higher diagnostic performance.~   "
84076|NCT01956877|"~     To assess normal values of EGJ distensibility in healthy volunteers.~   "
84077|NCT01956864|"~     The purpose of this study is to evaluate the safety and tolerability of a high dose of~     vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD~     will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory~     and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.~   "
84078|NCT01956851|"~     Since the discovery of kisspeptin as a gate-keeper of hypothalamo-pituitary-gonadal axis,~     there has been tremendous interest in the molecule. The relevance of kisspeptin as~     regulatory molecule for the reproductive system has been well documented in significant~     number of trials. (1, 2) This leads to the possibility that kisspeptin could be involved in~     an equally pivotal role in the other sites, where it is located, namely pancreas.~      While various animal experiments have suggested that kisspeptins regulate insulin secretion,~     we do not know if this is also true in humans. The investigators hypothesize that kisspeptin~     levels are significantly low in individuals who have low endogenous insulin secretion.~      While various animal experiments have suggested that kisspeptins regulate insulin secretion,~     the investigators do not know if this is also true in humans. Investigators hypothesize that~     kisspeptin levels are significantly low in individuals who have low endogenous insulin~     secretion.~      Thus investigators are conducting this study to understand the link between endogenous~     insulin secretion and kisspeptin levels among individuals with various levels of insulin~     secretory defect as seen in diabetics. Investigators believe that this will help understand~     the physiologic mechanisms, and kisspeptin based insulin regulation among individuals with~     diabetes mellitus.~   "
84088|NCT01956721|"~     The aim of this project is to investigate the impact of heart failure (HF) on calcium~     homeostasis, mitochondrial function and oxydative stress in human skeletal muscle. The role~     playing by circulating factors such as cytokines and catecholamines will also be evaluated.~     24 HF patients wiil be enrolled in the study: 12 male volunteers with a fraction of ejection~     ≥ 50% and 12 male volunteers with a fraction of ejection ≤ 35%. They will be compared to 12~     sedentary healthy male volunteers, matched on age and physical activity.~   "
84089|NCT01956708|"~     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion~     provides peri-operative myocardial protection, is safe and improves prognosis in patients~     undergoing elective CABG surgery.~      The signal transfer from limb to heart is unknown. Thus, the aim of this study is to~     identify the pathways which transfer the cardioprotective signal from the~     ischemic/reperfused extremity to the heart in humans undergoing surgical coronary~     revascularization.~   "
84079|NCT01956838|"~     Rationale: The appearance of tastants in the small intestine can result in the activation of~     a negative feedback mechanism from different parts of the intestine to the stomach, the~     small intestine and to the central nervous system. These processes inhibit food processing,~     appetite sensations and food intake, and furthermore they increase feelings of satiety and~     satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg~     (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of~     these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in~     total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides~     CCK and GLP-1.~      Study design: To assess the effect of intraduodenal infusion of single ingredients and a~     combination of tastants (bitter, umami and sweet) on ad libitum food intake.~      Secondary Objective(s):~        1. To investigate the effect of intraduodenal delivery of a combination of tastants on~          satiation.~        2. To assess the effect of intraduodenal delivery of a combination of tastants on~          gastrointestinal hormone release.~        3. To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate~          on the parameters as mentioned under the primary objective, and under secondary~          objectives 1 and 2.~        4. To compare the effects, as mentioned under the primary objective, and under secondary~          objectives 1 and 2, of the combination of tastants to those of the three single~          tastants quinine, rebaudioside A and monosodium glutamate.~   "
84080|NCT01956825|"~     The purpose of this study is to determine whether the dual therapy of the amino acid~     L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with~     non alcoholic fatty liver disease (NAFLD).~   "
84081|NCT01956812|"~     The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose~     gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer~     patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which~     was a gemcitabine-containing regimen).~   "
84082|NCT01956799|"~     The study aims to evaluate the molecular mechanism underlying the erythroid response~     observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated~     with Deferasirox or Deferoxamina.~   "
84083|NCT01956786|"~     To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and~     plasma total homocysteine.~   "
84084|NCT01956773|"~     The outcome of this research will be a demonstration that family health history (FHH) risk~     data can be used efficiently to deliver more effective healthcare in geographically and~     ethnically diverse clinical care environments. Although FHH is a standard component of the~     medical interview its widespread adoption is hindered by three major barriers: (1) a dearth~     of standard collection methods; (2) the absence of health care provider access to complete~     FHH information; and (3) the need for clinical guidance for the interpretation and use of~     FHH. In addition, the time constraints of the busy provider and poor integration of FHH with~     paper medical records or electronic medical records (EMR) impede its widespread use. The~     investigators hypothesize that patient-driven and electronic collection of FHH for risk~     stratification will promote more informed decision-making by patients and providers, and~     improves adherence to risk-stratified preventive care guidelines. The study team will use an~     implementation sciences approach to integrate an innovative FHH system that collects FHH~     from patients. Intermountain Healthcare will provide the information technology expertise~     with EMR design to develop an innovative solution to a storage model standard for FHH data~     as well as a centralized standards-compliant open clinical decision support (OpenCDS) rule~     development architecture to analyze FHH and to generate evidence-based, individualized,~     disease risk, preventive care recommendations for both patients and providers.~   "
84085|NCT01956760|"~     The aim of this clinical study is to observe the therapeutic effect of acupuncture and~     intradermal acupuncture in the treatment of insomnia~      Participants were randomized into the acupuncture group and control group. Both groups were~     treated 3 times in a week and assessed before and after the treatment.~      Hypothesis :~        1. Acupuncture group will produce superior effect in the treatment of insomnia compared~          with control group.~        2. Acupuncture group will produce superior improvement in anxiety, depression, quality of~          life, sleep log, recognition, attention, and memory.~   "
84086|NCT01956747|"~     The purpose of this study is to assess whether the presence of a Myelodysplastic Syndrome~     (MDS) , Idiopathic Cytopenia of Undetermined Significance (ICUS) or Idiopathic Dysplasia of~     Undetermined Significance (IDUS), correlates with treatment intensity and clinical outcome~     in older patients with advanced malignancies receiving palliative chemotherapy. We will~     study the relation between sarcopenia, comprehensive geriatric assessment en~     pharmacokinetics with treatment related toxicity as well. We hypothesize that a standardized~     flow cytometry test to determine bone marrow capacity, a Comprehensive Geriatric Assessment~     and/or measurement of human body composition with computerized tomography will provide an~     accurate tool to optimize treatment strategies in elderly patients with advanced~     malignancies.~   "
84087|NCT01956734|"~     Phase I trial, unicentric, uncontrolled. Intratumoral injection or intramural (into the~     resected tumor cavity) of DNX2401 into brain tissue will be followed by up to two 28 - day~     cycles of oral temozolomide (TMZ) in schedule of 7 days on/7 days off to evaluate safety of~     the combination. Completion of two full cycles of TMZ will be dependent upon tolerance and~     toxicity.~      The rationale in using the virus with chemotherapy begins with the lessons learned in many~     clinical trials in glioblastoma (GBM) about both the great difficulty of treating this~     disease with monotherapy and the limitations of the therapeutic virus. The best clinical~     results in recent years have been achieved with combinations of multiple therapeutics~     efforts, including, maximum resection and chemotherapy, immunotherapy and targeted~     therapies.~      There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our~     trial design. The dose-dense schemes of TMZ like the one we will use, have been developed~     with the aim to saturate o6-methylguanine-DNA-methyltransferase (MGMT). The published~     results to date have shown reasonable toxicity albeit with modest efficacy' these schemes~     are now in phase III trials. In addition, autophagy triggered by TMZ could help viral~     replication in the tumor cells 11.~      The last argument in favor of this virus + TMZ combination is the proved efficacy in killing~     GBM tumor stem cells. In vitro and animals models have shown this combination is much more~     effective that any of the treatments alone against GBM stem cells and the tumors derived~     from them.~   "
84090|NCT01956695|"~     Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell~     lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy~     of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be~     observed in PCNSL.~      This study will assess the efficiency of the the combination of lenalidomide and rituximab~     in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with~     lenalidomide alone in maintaining the response.~   "
84091|NCT01956682|"~     The primary objective of this trial is to show that an hypoallergenic infant starter formula~     containing starch and the probiotic L. reuteri decreases the severity of~     regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have~     taken it for 4 weeks, in comparison with a standard infant starter formula.~   "
84092|NCT01956669|"~     The purpose of this study is to find out what effects, good or bad, pazopanib (GW786034),~     National Service Center (NSC) # 737754, has on children, adolescents and young adults~     between 12 months and less than or equal to 18 years of age with relapsed or refractory~     rhabdomyosarcoma, non rhabdomyosarcomatous soft tissue sarcoma, Ewing sarcoma, relapsed or~     refractory osteosarcoma, neuroblastoma (measurable and/or evaluable), or hepatoblastoma.~     This is a two-stage open label phase II trial of pazopanib in children, adolescents and~     young adults with recurrent or refractory solid tumors. Eligible subjects will receive~     pazopanib daily as an oral tablet (450 mg/m^2/dose) or as a powder for suspension (225~     mg/m^2/dose) in 28 day cycles. The maximum dose to be administered daily for tablets is 800~     mg and for suspension 400 mg. Subjects will be closely monitored with clinical and~     laboratory observations for side effects. Response to treatment will be evaluated using~     appropriate imaging studies. In the absence of severe toxicity or progressive disease,~     subjects may continue receiving pazopanib.~   "
84093|NCT01956656|"~     Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective~     chemical adjunctive measures will likely significantly contribute to overall oral health,~     the function of which should be to augment mechanical plaque control. Traditionally, in~     Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract~     of lotus leaves have demonstrated significant antibacterial activity against some of the~     periodontopathogens.~   "
84094|NCT01956643|"~     Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as~     surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return~     of normal gut function Chewing gum has recently been used as a form of sham feeding to~     stimulate acceleration of gut function after abdominal surgery.~      The investigators hypothesize that sham feeding with chewing gum will accelerate return of~     gut function after liver transplantation.~   "
84095|NCT01956630|"~     Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment~     for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient~     survival, is so far treated by second transplantation and donor leukocyte infusion (DLI),~     which seems to have high risk and low survival. Need for a new medication on relapse is~     urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer~     (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual~     disease. This randomized study was conducted to evaluate the feasibility and effective of~     genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.~   "
84096|NCT01956617|"~     The Shamrock method is a new ultrasound-guided lumbar plexus block. The aim of the study~     is to determine the minimum effective volume of ropivacaine 0.5% required to produce an~     effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down~     method study design, 30 patients scheduled for elective total hip and knee arthroplasty will~     be included in the study.~   "
84097|NCT01956604|"~     Delirium (acute confusional state)is characterized by an acute decline in attention and~     cognition, and is a common clinical syndrome in elderly patients.~      The purpose of this randomised, controlled, parallel group pilot trial is to explore~     superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at~     the acute geriatric ward.~      We will also study the feasibility of oral clonidine in a geriatric ward and effects of~     clonidine upon a variety of outcomes as a means to design a more definite study later.~   "
84098|NCT01956591|"~     Evaluate the long term efficacy and side effects of oxybutynin in the treatment of~     hyperhidrosis.~   "
84099|NCT01956578|"~     This study will evaluate the correlation between the respiratory rate derived from the~     Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate~     obtained from an external respiratory band in patients previously implanted with a Reveal~     for unexplained syncope or suspected arrhythmia.~   "
84100|NCT01956565|"~     The feasibility study will involve mixed methods, this means interviews as well as~     assessment of treatment with inspiratory muscle training therapy (IMT). There are two~     pathways within the study depending on whether people want to have inspiratory muscle~     training. People who accept to have inspiratory muscle training will have assessments before~     training, after 8 weeks of training and at 6 month follow up in addition to interviews~     before and after the study (at 6 months). For those who choose not to have the inspiratory~     muscle training the investigators will offer them an interview so that the investigators can~     find out more about what might have made the study more appealing or what treatments they~     would have preferred. The investigators will also ask if they wish to be followed up with~     baseline assessments for the study period and if the investigators can access health~     records.~      Interviews~      Semi-structured interviews lasting approximately an hour will be performed at the beginning~     of the study with participants who accept the IMT pathway and those who decline IMT until no~     knew themes are raised. These interviews will be used to provide information on reasons for~     declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment~     preferences and opinions regarding study design and outcome measures (see Interview Topic~     guide). The interviews will be taped and transcribed verbatim. A follow up interview with~     study participants who have received IMT will be conducted at 6 months addressing attitudes~     to IMT and study design and whether they have decided that they wish to engage with other~     services (such as pulmonary rehabilitation and smoking cessation).~      Inspiratory Muscle Training (IMT) method~      Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic~     device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax).~     This means that each breath in through the device is set at 60% of the maximum force you are~     able to create when you breathe in rather than at full force. 30 breaths are performed at~     high velocity (paced initially over a period of 15 minutes to allow recovery between each~     breath through the device). Once established it is anticipated that each training session~     should take no more than five minutes. Training is performed twice a day, 5 days per week~     for the first 8 weeks. Training will be titrated (set to a level suitable for the~     participant) and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks~     training the participants are advised to continue training unsupervised, twice a day, 3~     times per week for a further 18 weeks.~   "
84101|NCT01956552|"~     The primary objective is to compare the phenotype and genotype of the primary tumor with~     those of its metastases in order to optimize the treatment of metastatic disease, in~     patients presenting with first metastatic progression of breast cancer.~   "
84148|NCT01955941|"~     The purpose of this study is to learn how blood flows to tumors in patients treated with~     I-125 plaque brachytherapy for uveal melanoma.~   "
84102|NCT01956539|"~     Heart failure is the most common heart disease with increasing incidence due to the aging of~     the population is improving the initial prognosis of various conditions that lead to more or~     less progressive heart failure.~      Heart failure is of great variety of clinical and pathophysiological forms necessitating the~     creation of quality records to clarify each of these forms.~      Many types of cardiomyopathies exist, some of which are infrequent but with specific care.~      At the French level, few data exist. In addition, the therapeutic management changes~     regularly.~      New European recommendations (endorsed by the French Society of Cardiology = FSC) were~     published in May 2012. Many therapeutic approaches are being evaluated. The course of care~     and how to take non-drug load (network monitoring, rehabilitation ...) have become important~     issues that have hardly been analyzed by existing records.~      This also leads to better define the different forms of this disease, their natural history~     and methods of management applied in real life. The register of FSC follows the registry of~     the European Society of Cardiology (ESC)Heart Failure (HF) Long Term (CCTIRS No.~     11.355bis) with inclusions will be completed in November 2012. This new study aims to~     generate more accurate data on a number of points and be more representative for a wider~     selection of patients, the French level.~   "
84103|NCT01956526|"~     The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two~     treatment groups, CORolla™ Stand-alone group and  AVR & CORolla™ Add on group.~   "
84104|NCT01956513|"~     The main objective of the study is to assess the sensitivity and the specificity of the~     variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant~     chemotherapy or after modification of the treatment sequence, the pathological response at~     the end of chemotherapy~   "
84105|NCT01956500|"~     The primary purpose of this study is to assess the effect of 8-weeks ingestion of the~     Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on~     joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood~     inflammation biomarkers in adults with self-reported joint pain.~   "
84106|NCT01956487|"~     Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites~   "
84107|NCT01956474|"~     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and~     biochemical stability of the cornea by inducing additional cross-links within or between~     collagen fibers using UVA light and the photo- mediator riboflavin.~   "
84108|NCT01956461|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients~     under clinical practice. The participants are treated in the investigators hospital, who are~     under severe osteoporotic condition.~      Several determinants were reported to be related to subsequent BMD increase, such as~     baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but~     comprehensive discussion is lacking. Specifically, there analyses were performed~     fragmentarily.~      The main objective of this study is to reveal the determinants of subsequent BMD increase~     and fracture preventing effect by teriparatide.~      Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly.~     As a result, there is a lot of nursing home. But there are few reports concerning to the~     efficacy of teriparatide treatment in nursing home patients. The second objective is to~     reveal the efficacy of teriparatide for patients living nursing home, especially BMD~     changes, bone turnover makers change, and adverse events.~   "
84109|NCT01956448|"~     To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity®~     stents in the treatment of unselected patients with ischemic heart disease.~   "
84110|NCT01956435|"~     This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate~     hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or~     left) will be treated. Treatments with the Xtrac Excimer laser will be performed twice~     weekly for 12 weeks using the typical vitiligo protocol. Our goal is to determine the~     effectiveness of excimer laser for repigmentation of idiopathic guttate hypomelanosis.~     Effectiveness will be graded by the blinded observer scale via photographic comparisons and~     will be graded by subject via survey every 4 weeks.~   "
84111|NCT01956422|"~     Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may~     reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia~     (PaO2<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of~     basal value.~   "
84112|NCT01956409|"~     The application of FCH PET in breast cancer diagnosis has not been reported.~      We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the~     similar pathophysiological mechanism to choline on proton MRS, and our study goals are:~        1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for~          localized findings on mammography and breast ultrasound.~        2. To investigate whether FCH PET findings are correlated with choline signals on proton~          MRS.~        3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated~          with factors related to clinical outcome and prognosis- that is, molecular markers,~          tumor staging, histologic grade of breast cancers.~        4. For localized advanced breast cancer, to investigate the treatment response to NAC~          using proton MRS and FCH PET, and to evaluate which modality is more sensitive.~        5. To investigate the usefulness of FCH PET for whole body staging for breast cancer~          patients.~   "
84113|NCT01956396|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
84114|NCT01956383|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
84115|NCT01956370|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
84116|NCT01956357|"~     The aim of this study was to analyse the acute and chronic effects of two aerobic-training~     models performed in water and on dry land on cardiorespiratory, functional, metabolic,~     hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).~   "
84117|NCT01956344|"~     The purpose of this research is to measure changes in brain activity with functional~     magnetic resonance imaging (fMRI) before and after cognitive-behavioral therapy for~     compulsive hoarding. Cognitive-behavioral therapy aims to help people change the thoughts~     and behaviors that maintain symptoms of hoarding. The investigators intend to enroll~     approximately 80 people with hoarding disorder and 40 people with no psychiatric disorder,~     between the ages of 20 and 60, for this study. The investigators believe that after~     treatment there will be changes in the brain activity of individuals with compulsive~     hoarding.~   "
84118|NCT01956331|"~     schema : Prospective prognostic study The main objective is to study the value of the~     Comprehensive Geriatric Assessment in predicting the risk of post operative complications~     after lung resection for cancer.~   "
84119|NCT01956318|"~     At 3 months, crenobalneotherapy session is superior to waiting list for patients with~     chronic venous insufficiency.~   "
84120|NCT01956305|"~     DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will~     be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to~     assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of~     multiple doses of DS-7309 in subjects with T2DM.~   "
84121|NCT01956292|"~     Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral~     haemorrhage and its consequences to clinical outcome~   "
84122|NCT01956279|"~     This study will investigate the use of adjunctive pregnenolone for the following:~        1. fatigue that has limited usual activity,~        2. musculoskeletal pain involving 2 or more regions of the body and,~        3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report)~          in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.~   "
84123|NCT01956266|"~     This study investigates a treatment protocol which holds the potential to significantly~     improve communication and quality of life for individuals affected by Parkinson's disease~     (PD). Disorders of emotional communication are widely reported in PD and can negatively~     impact quality of life by increasing social isolation and decreasing independence.~     Individuals with emotional prosodic communication disorders are often perceived as depressed~     or unconcerned about others. This seeming negativity can cause difficulties in~     relationships, and increased feelings of stress and burden in caregivers which may result in~     earlier placement in an institutional care setting. This innovative treatment program could~     improve care for individuals with PD, as well as other individuals who may be affected by~     disorders of emotional prosodic communication (e.g., stroke or traumatic brain injury).~   "
84124|NCT01956253|"~     This study will be a single subject study to evaluate the efficacy of the HER2 kinase~     inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene~     fusion.~   "
84125|NCT01956240|"~     The purpose of this study is to verify the effects of a stretching protocol for the~     pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during~     arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened~     pectoralis minor.~   "
84126|NCT01956227|"~     Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of~     persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in~     medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The~     effects of a fall are often compounded as it can lead to activity curtailment, physiological~     deconditioning, and institutionalization. Despite the importance of falls in persons with~     MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.~     The purpose of this investigation is to determine whether exercise based or educational~     based interventions are more suited for fall prevention in older adults with MS.~   "
84127|NCT01956214|"~     Both strength training and endurance exercise training are commonly prescribed to improve~     strength and function in patients with physical limitations caused by chronic disease or~     disability including chronic kidney disease (CKD). Individuals with CKD often have low~     physical function due to progressive declines in the performance of their kidneys. The low~     physical function leads to physical inactivity, which exacerbates these functional declines~     and promotes cardiovascular disease and bone disorders. In addition, severe functional~     limitations in some patients prevent them from exercising at a great enough intensity to~     provide significant benefits. As a result, alternative strategies are needed to maximize the~     benefits of exercise while decreasing injury risk.~   "
84128|NCT01956201|"~     The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and~     Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.~   "
84129|NCT01956188|"~     It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory~     properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid~     arthritis, although not with controversy. Systemic lupus erythematosus is an autoimmune~     disease characterized by a chronic inflammatory state which is associated with the disease´s~     clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially~     affect the inflammatory cytokine profile and clinical features of LES patients.~   "
84130|NCT01956175|"~     The purpose of this study is to evaluate whether electrical pharyngeal stimulation in~     addition to standard care can enhance short-term swallow recovery in tracheostomized~     dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham~     treatment plus standard care.~   "
84131|NCT01956162|"~     Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication~     committee (PROBE methodology), comparing Orthèse Diabète with conventional removable~     devices in terms of healing of ulcers.~      - Primary objective: Evaluate the efficiency of Orthèse Diabète compared to conventional~     removable devices, in terms of the proportion of diabetic patients whose principal ulcer~     will heal completely at 3 months.~   "
84132|NCT01956149|"~     Single-arm study to determine disease control rate in second- (or later) line treatment with~     cabazitaxel after the failure of palliative primary treatment.~   "
84181|NCT01955512|"~     In asthma, breathing in an allergen, such as house dust mite induces inflammation in the~     airways. This process appears to involve an interaction between two different sorts of blood~     cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose~     of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor~     on platelets, reduces inflammation following breathing in house dust mite in people with~     mild asthma.~   "
84133|NCT01956136|"~     Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability~     among adolescents and young adults. Especially the cognitive, emotional, and motors deficits~     caused by TBI often impair everyday psychosocial functioning, quality of life and ability to~     work. The purpose of the study is to determine the long-term effect of music-based~     rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents~     and young adults, and to study the neural mechanisms that underlie behavioural recovery and~     the efficacy of music.~   "
84134|NCT01956123|"~     This trial investigates the immunogenicity of FE 999049 in repeated cycles.~   "
84135|NCT01956110|"~     This trial investigates the effects of FE 999049 compared to Gonal-F.~   "
84136|NCT01956097|"~     The objectives of the current study are to evaluate the efficacy and safety of HX106 in~     healthy adults with subjective memory complaints for improving neurocognitive functions and~     to find the changes of brain using magnetic resonance imaging and their associations with~     the neurocognitive function enhancement.~   "
84137|NCT01956084|"~     In this study, investigators are trying to see if LMP specific cytotoxic T lymphocytes~     (CTLs) will prevent or treat disease called Epstein Barr Virus (EBV) Disorder including~     either Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic~     active EBV infection syndrome (SCAEBV) or Leiomyosarcoma which has come back or has not gone~     away after treatment, including the best treatment. Investigators are using special immune~     system cells called third party LMP specific cytotoxic T lymphocytes (CTLs), a new~     experimental therapy.~      Some patients with Lymphoma or SCAEBV or Leiomyosarcoma show evidence of infection with the~     virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of~     their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's~     and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer~     cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the~     body's immune system and escape destruction. The investigators want to see if special white~     blood cells, called T cells, that have been trained to kill EBV infected cells can survive~     in patient's blood and affect the tumor or infection.~      Investigators used this sort of therapy to treat a different type of cancer that occurs~     after bone marrow or solid organ transplant called post transplant lymphoma. In this type of~     cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in~     the laboratory that recognized all 9 proteins and were able to successfully prevent and~     treat post transplant lymphoma. However in Hodgkin Lymphoma, the tumor cells and B cells~     only express 2 EBV proteins. In a previous study they made T cells that recognized all 9~     proteins and gave them to patients with Hodgkin Lymphoma. Some patients had a partial~     response to this therapy but no patients had a complete response. They think one reason may~     be that many of the T cells reacted with proteins that were not on the tumor cells. In this~     present study the investigators are trying to find out if the investigators can improve this~     treatment by growing T cells that recognize proteins expressed on EBV infected Lymphoma~     cells and B cells called LMP-1 and LMP2. These special T cells are called third party LMP~     1/2 -specific cytotoxic T-lymphocytes (CTLs). These LMP-specific cytotoxic~      T cells are an investigational product not approved by the Food and Drug Administration.~   "
84138|NCT01956071|"~     The purpose of this study is to assess full-time workers'impressions and acceptability of a~     prototype pedal desk. The pedal-desk is a semi-recumbent (upright) portable pedal mechanism~     that allows workers to complete tasks in a traditional seated position.~   "
84139|NCT01956058|"~     After a curative treatment by radiotherapy for localized prostate cancer, between 20% and~     50% of patients may have a biological relapse as a progressive re -rise of PSA. After~     prostate brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk~     factors initially present, some patients will have a micro metastatic disease at the time of~     re-rise, but others will have a true local recurrence purely intra-prostate. Local~     recurrence after radiotherapy is associated with a high incidence of distant metastatic~     relapse and poor overall survival. For these reasons, the possibility of offering a local~     treatment for this selected population of patients can have a major therapeutic interest and~     allow changing a situation often considered palliative to the possibility of a second~     curative treatment.~      Currently, there is no consensus regarding the optimal management of patients with purely~     local recurrence after prostate irradiation at first intention. When an external~     radiotherapy or brachytherapy is performed as first choice in a patient with prostate~     cancer, several remedial treatments have been proposed, with controversial results the~     decision-making for clinicians and for difficult patients. These main therapeutic options~     remedial (surgery, cryotherapy and brachytherapy) have the potential for complications such~     as rectal injury, impotence or incontinence Brachytherapy is a new salvage treatment being~     evaluated in the United States (Phase II study of the Radiation Therapy Oncology Group No.~     0526). Several retrospective trials have shown very encouraging results in terms of acute~     toxicity and biochemical control in the short term. Thus, a team from Mount Sinai in New~     York recently published for the first time 10 years retrospective results with this~     approach. In their experience after treatment failures with external beam radiotherapy or~     brachytherapy, a dose of 122 Gy was delivered over 90% of the prostate gland. Doing this~     they observed biochemical control rates and survival specific of 54 % and 96 %, respectively~     at 10 years, with an hormone treatment associated (median 6 months) in 84 % of cases. Four~     patients had grade 3 toxicity or higher (11%). To reduce the rate of late toxicities the~     team from the University Of California San Francisco (UCSF), tested focal brachytherapy~     guided by functional MRI (MRI spectroscopy) to re-treat local recurrence after initial~     brachytherapy as monotherapy or boost. By delivering 144 Gy on recidivism objectified on~     MRI, the authors observed that a minimal dose of 37Gy covered 90 % of the prostate gland to~     treat the risk of microscopic disease. Doing this, the rate of observed toxicities and~     biochemical control appeared encouraging, with a median follow-up of 2 years, since no grade~     3 toxicity was observed and 74% of patients achieved a PSA nadir <0.5 ng / mL without~     associated hormone. In case of external radiation or brachytherapy, several attempts~     proposed to associate an injection of hyaluronic acid gel to the prostate - rectum interface~     to spare healthy tissue irradiated and thus reduce the rate of radiation proctitis. The~     feasibility of implementing this gel has been demonstrated in patients with non- irradiated~     tissues. No inherent toxicity of the injection of hyaluronic acid gel has been described~     after prostate brachytherapy first line. The feasibility of this injection remains unproven~     to date on patients previously irradiated externally or by brachytherapy. We hypothesize~     that the risk of radiation proctitis and fistulas front prostate could be reduced using this~     technique in this indication.~      We propose to carry out a French prospective multicenter phase II trial combining~     brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk~     of radiation proctitis and / or recto -urinary fistula in a patient population hyper-~     selected with a high probability of isolated local recurrence.~   "
84140|NCT01956045|"~     How to determine the decision-making capacity of critically-ill patients remain unclear. The~     investigator study the differences between standardised evaluation and subjective medical~     evaluation.~   "
84141|NCT01956032|"~     The purpose of this study was to evaluate the use of resources during titration of Duodopa~     at home.~   "
84142|NCT01956019|"~     This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE~     MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study~     are to correlate histological response of soft tissue sarcoma after pre-operative~     radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact~     of these on early response prediction. Detected changes may reflect the sensitivity of the~     tumour to radiotherapy and may be associated with long term outcomes after treatment.~      15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment~     will be recruited to this study.~      Patients will have an additional three specialised MRI scans: one prior to the start of~     radiotherapy, one during the second week of radiotherapy while on treatment and one scan a~     week before surgery but after the completion of radiotherapy.~      Post-operatively, results of the histological examination of the sarcoma will be correlated~     to both the MRI scan data and outcomes after treatment~   "
84143|NCT01956006|"~     Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening~     cardiovascular disorder, characterised by marked symptomatic limitation and frequent~     hospitalization. It is particularly prevalent in older individuals (up to 10% of the~     population) and it has become the most common cause for hospitalization in people >65yrs. As~     such it is also one of the leading consumers of healthcare spending. Recurrent~     hospitalization is frequently due in significant part to the lack of viable therapeutic~     options for severe HF. During hospital admission, medications through a drip to give through~     a vein (intravenous therapy), is required to improve heart pumping capacity (such as~     milrinone).They are frequently used and in many cases prolonged treatment periods of~     intravenous therapy are required. In a growing number of cases, there is a need to continue~     this treatment at home, however this is particularly costly and often complicated by~     intravenous line infection. As such there is an expanding need for therapeutic options in~     patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid~     release form of oral milrinone were examined, however these studies demonstrated adverse~     effects due to its quick release.~      This study aims to determine the safety and tolerability of slow release oral milrinone in~     advanced HF patients with no further clinical option and to evaluate its effects on HF~     status.~   "
84144|NCT01955993|"~     Fentanyl is a frequently used pain medication in pediatric and adult anesthesia. Although~     there are some studies considering the breakdown of oral, transmucosal and intravenous~     fentanyl preparations in children, the disposition of fentanyl in pediatric patients has not~     been sufficiently described. This study aims to show that the clearance of fentanyl in obese~     children and adolescents is increased as compared to children with a normal weight.~     Consequently, the elimination half-life of fentanyl is different in overweight and obese~     children from that in children having a normal body weight.~   "
84145|NCT01955980|"~     The study should create data for the selection of a clinically relevant endpoint to assess~     the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic~     Rhinosinusitis.~   "
84146|NCT01955967|"~     The aim of this randomized double blind, placebo controlled, crossover study is to~     investigate in a prospective way the effect of lidocaine in patients with trigeminal~     neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine~     (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be~     measured with pain diaries and visual analogue scales.~   "
84147|NCT01955954|"~     The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS)~     in treating the symptoms of panic disorder.~   "
84149|NCT01955928|"~     The object of this study is to compare internet-delivered treatment for insomnia to a~     waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral~     2) waiting-list. Participants in the waiting-list condition receive treatment after the~     post-test. The interventions consist of: diary; psycho-education; relaxation exercises;~     stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about~     sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular~     scientific website to fill out online questionnaires. Participants will fill out~     questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up.~     In this study we are interested in sleep-related worry and daily complaints measured with a~     diary. We expect that the online intervention ameliorates both the sleep-related worry and~     the daily complaints. Furthermore, we expect that the sleep related worry mediates the~     effect of the intervention on sleep- and daily complaints.~   "
84150|NCT01955915|"~     The purpose of this study is to see if mapping blood vessel patterns with optical coherence~     tomography (OCT) will help identify life-threatening choroidal tumors in their early stages~     and improve overall patient survival through early detection.~   "
84151|NCT01955902|"~     The purpose of the proposed study is perform focus groups to identify and prioritize~     features of the SubAID application (APP). The SubAID APP is smartphone APP being created to~     support patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have~     difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their~     prescribed manner can cause negative health outcomes.~      Focus group participants will be asked to elaborate on medication-taking patterns that work~     best for them, pitfalls associated with poor adherence and offer opinions upon what~     features/functions the SubAID APP should perform to be most helpful to them. The focus group~     is designed to remain open-ended and allow free discussion regarding each particular topic~     that the moderator will bring up.~   "
84152|NCT01955889|"~     Persons with Parkinson Disease (PD) face significant declines in function resulting in~     greater disability. Function can improve through participation in exercise, yet many people~     with PD are physically inactive. Given that people with PD live long lifespans following~     diagnosis; it is essential to include routine exercise into their lives over the long-term.~     Physical therapy is effective in improving function in persons with PD. However,~     participation in on-going physical therapy indefinitely is not a realistic option due to~     limited healthcare resources. Interventions using mobile health technologies allow physical~     therapists to stay connected to patients over time potentially improving their ability to~     meet the changing needs of patients with PD. Innovative approaches using mobile health~     technology may improve outcome; however, the effectiveness of different approaches to~     improve function and reduce disability in PD is unknown.~      The purpose of this study is to compare the effectiveness of two interventions to improve~     function and health-related quality of life in 65 people with PD. In one study group,~     participants receive a home exercise program, in written format, to continue on an~     independent basis. In the other study group, participants are instructed to continue with an~     exercise program, in their home, delivered using videos of the exercises on a computer~     tablet device. This use of mobile-Health technology allows the physical therapist to~     remotely monitor participants' progress and modify the exercise program to meet the changing~     needs of each patient. The long-term objective of this research is to determine the most~     efficient and effective way to improve function that can be widely disseminated to persons~     with PD.~   "
84153|NCT01955876|"~     This study is a regulatory post-marketing surveillance in Japan, And it is a local~     prospective and observational study of patients who have received Fosrenol.~      The objective of this research is to collect information on the safety of Fosrenol after its~     launching, which means collecting information on adverse events, especially adverse events~     in the digestive system including constipation and serious adverse events, and adverse drug~     reactions when the drug is administered to the below-mentioned target patients for six~     months.~      The secondary objective is to collect information on the safety of the drug when~     administered for more than six months, which means collecting information on the safety of~     the drug when administered for up to 12 months to the target patients who have already been~     treated with the drug for six months. And also if at the time of 12 months after~     administration of Lanthanum carbonate the dialysis is not conducted, extending its'~     administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The~     efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH~     (parathyroid hormone) level change.~   "
84154|NCT01955863|"~     Radical prostatectomy has become the gold standard treatment for prostate cancer.~      Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers~     around the world start to develop laparoscopic and robotic approach over the past years. The~     problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep~     learning curve with a high initial complication rate, and the use of robotic assistance~     surgery despite of lower learning curve is associated with higher surgical supply and~     operative room costs. These costs may have a significant impact on overall cost of prostate~     cancer care especially in Brazil.~      In Brazil, the open route for radical prostatectomy is still the most frequent approach. One~     of the disadvantages of open prostatectomy from the other surgeries is the longest hospital~     stay. However, the question of what length of stay after this operation is optimal and~     necessary is unresolved. In this trial the investigators have compared a randomized group of~     patients that had discharged on postoperative day 2, 1 and same day surgery. The~     investigators had intent to evaluate the feasibility of ambulatory open radical~     prostatectomy (patient discharge in the same day of surgery - average 12 hours of~     hospitalization) maintaining patient satisfaction and safety.~   "
84167|NCT01955694|"~     This study will be conducted in subjects with clinical diagnosis of worsening chronic heart~     failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease~     (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for~     at least 3 months prior to emergency presentation to hospital using a multi-center,~     randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group~     design.~      Primary objective of the study is to investigate efficacy [percentage of subjects with a~     relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more~     than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of~     BAY94-8862 given once daily.~   "
84155|NCT01955850|"~     The object of this study is to compare internet-delivered treatment for insomnia to~     face-to-face treatment and a waiting-list. In this study participants are randomized to: 1)~     online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention;~     3) waiting-list. Both the online and face-to-face interventions consist of: diary;~     psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction;~     challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with~     insomnia will be invited via a popular scientific website to fill out online questionnaires.~     Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up,~     and 6-month follow-up. Participants on the waiting-list receive online treatment after the~     first post-test. The investigators expect that the online-delivered treatment and the~     face-to-face treatment are equally effective.~   "
84156|NCT01955837|"~     To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer~     refractory or intolerable to standard chemotherapies.~   "
84157|NCT01955824|"~     Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of~     topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among~     physicians, institutions and geographic locations across the globe. Commonly used topical~     anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%),~     tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the~     flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort.~     However, the optimal dosage and strength of topical lignocaine that should be used during~     fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the~     efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing~     flexible bronchoscopy.~   "
84158|NCT01955811|"~     Patients with need of platelet transfusion for any reason will participate in this study.~     Directly before the start of infusion and one hour after the end of platelet transfusion~     blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood~     clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion~     will be compared. The study hypothesis is that treatment with Fibrinogen results in a better~     stabilisation of blood coagulation.~   "
84159|NCT01955798|"~     The Veress needle is the laparoscopic entry technique most commonly used among~     gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is~     uncommon to gynecologists.~      This prospective and randomized study will compare the two entry techniques with regard to:~        -  Complications related to the entry technique and previous surgeries~        -  Time taken to enter the abdomen~        -  The number of attempts taken to enter the abdomen~   "
84160|NCT01955785|"~     Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by~     several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and~     mechanically ventilated in order to secure a stable PaCO2. This study compares two~     ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume~     Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies~     results in a more stable ICP and arterial CO2 pressure (PaCO2).~   "
84161|NCT01955772|"~     Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to~     frequent secondary malnutrition to metabolic and digestive troubles due to conditioning~     regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft~     versus host disease). In the absence of appropriate nutritional support, myeloablative~     conditioning lead to a rapid serious denutrition. But, it is known as negative independent~     prognostic factor of overall survival of patients who presented malignant hemopathy treated~     by high-dose chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and~     decreases quality of life. In AHSCT with myeloablative conditioning, introduction of~     nutritional support is recommended. However, type of nutritional support remains not clearly~     defined. Parenteral nutrition is user but favour infections and secondary effects~     potentially decrease by intravenous glutamine. Few previous studies with low number of~     patients, mainly retrospective or combining allo-and auto HSCT had shown feasibility,~     acceptable tolerance and low cost of enteral nutrition (EN). A recent prospective~     no-randomized study in 45 adults patients who had undergone AHSCT with myeloablative~     conditioning find a significant decrease of day-100 mortality (5% vs 30%), of infection~     mortality, of median duration of parenteral nutrition (PN) and prevalence of GvH (Graft~     versus Host Disease) grade III-IV in EN (enteral nutrition) group. These results had to be~     confirmed by a randomized study. As EN is 4 to 5 more cheaply than PN, besides~     mortality/morbidity stakes for the patient, this study could have potential economic~     interest.~   "
84162|NCT01955759|"~     The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone~     and statine is better than beta-blocker alone for the prevention of atrial fibrillation~     after coronary by-pass surgery.~   "
84163|NCT01955746|"~     The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan~     through the new genetic study methods.~   "
84164|NCT01955733|"~     The primary objective of this trial is to evaluate the long-term safety of BI 695500 in~     adult patients with moderately to severely active rheumatoid arthritis (RA) who have~     successfully completed treatment in Trial 1301.1.~   "
84165|NCT01955720|"~     To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075~     dose(s) effective to reverse prolongation of blood coagulation time by dabigatran~   "
84166|NCT01955707|"~     The primary objective of the study is to determine whether one 300 mg dose of intravenous~     (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic~     resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or~     at >6 to ≤9 hours from when they were last known normal (LKN).~      The secondary objectives of this study in this study population are as follows: to assess~     the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess~     efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to~     assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the~     safety of natalizumab in participants with acute ischemic stroke.~   "
84168|NCT01955681|"~     This is a retrospective, non-interventional, multicenter, observational chart review study~     to explore the clinical benefits of retreatment with TKI in the real world.~   "
85575|NCT01937286|"~     Within community with high incidence of HCC, stretching the limits could be justified based~     on tumor characters and its biological behavior~   "
84171|NCT01955642|"~     Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second~     leading cause of dementia and the third leading cause of death in France.~      Clopidogrel is one of the recommended first line in the secondary prevention of AIC non~     cardioembolic origin. However recurrences occur in approximately 9% of patients receiving~     clopidogrel. Some studies in patients with coronary artery disease have made the connection~     between these treatment failures and non-biological response to clopidogrel. This~     non-biological response is found for approximately 30% to 50% of patients. Several~     mechanisms may explain this non-response. The most accepted mechanism is pharmacokinetic.~     Indeed, clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP)~     and a transformation by hepatic cytochrome into active metabolites. The genetic polymorphism~     of proteins involved in these two steps explain the low plasma concentration of active~     metabolites and thus the low efficacy of clopidogrel in some patients.~      A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic~     receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor~     (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response~     to clopidogrel.~   "
84172|NCT01955629|"~     Primary Objectives:~      Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and~     capecitabine (XELOX) combination to be used in the Part 2 of the study.~      Study Part 2: To assess the percentage of participants without progression of the disease at~     6 months after the start of maintenance therapy with aflibercept single-agent, following the~     first-line induction therapy with XELOX and aflibercept combination in participants with~     previously untreated metastatic colorectal cancer.~      Secondary Objective:~      Study Part 2: Include the evaluation of progression free survival, overall survival,~     response to treatment, the overall safety (during induction and maintenance therapy) and the~     assessment of aflibercept pharmacodynamics and biomarkers parameters.~   "
84173|NCT01955616|"~     The purpose of this study, called MOVE-PD, is to investigate how individuals with~     Parkinson's disease (PD) and chronic constipation (CC) respond to RM-131 as compared to~     placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel~     movements over a 14-day period. The study will also evaluate the safety and tolerability of~     the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms~     related to chronic constipation in patients who are unsatisfied with other therapies they~     have tried for constipation.~   "
84174|NCT01955603|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics~     (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects~     with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate~     (MTX).~   "
84175|NCT01955590|"~     Posttraumatic stress disorder (PTSD) is a frequently occurring and often debilitating~     anxiety disorder resulting from exposure to trauma. Trauma-focused cognitive-behavioural~     therapies, such as Eye movement desensitization and reprocessing (EMDR), are generally~     considered to be evidence-based treatments for PTSD. Although a majority of patients achieve~     improvement, a substantial minority either drop out of treatment, present with residual~     symptoms following treatment or fail to make any improvement. Furthermore, a substantial~     portion of the clinical trials on PTSD is characterised by major methodological limitations.~     In addition, there's a pressing need for research on mediators of treatment outcome. Taken~     together, these results highlight the need for methodological rigorous and stringent~     clinical trials comparing treatment modalities for PTSD. The first aim of this study is to~     investigate whether a treatment not based on the principles of exposure, i.e. metacognitive~     therapy (MCT) is as efficient as exposure-based treatments. The second aim to elucidate~     potential mediators of treatments effects by incorporating process-related variables.~   "
84176|NCT01955577|"~     The purpose is to study:~        1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an~          external ring fixator~        2. if vitamin D supplement facilitates fracture healing~        3. a possible relation between vitamin D deficiency and the risk of complications and the~          time of fracture healing~   "
84177|NCT01955564|"~     This is a prospective, 8-day, randomized, double-blind, placebo-controlled,~     sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single~     escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12~     volunteers each will participate in this study, with the first 9 volunteers in each cohort~     to qualify being randomized to receive study medication and the remaining 3 to be used as~     backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive~     NW-3509A and 3 subjects will receive placebo.~   "
84178|NCT01955551|"~     Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians~     identify many parents who could benefit from such programs. Low-income children have high~     rates of behavior problems and their family system and environmental exposures often lead to~     cumulative and daunting levels of risk for poor functional outcomes; their parents are~     highly likely to benefit from parenting supports. However, low-income families are the most~     likely to drop out of parenting interventions, meaning the families and children with the~     greatest need receive the least support. Fewer than 25% of low-income families recruited to~     parenting programs will participate in even one session, and only about half of these~     parents will participate in more than half of the sessions offered. The aims of this trial~     are:~      Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as~     compared to an attention control (AC) condition, will increase the engagement of low-income~     parents of preschoolers in an evidence-based parenting skills group (the Incredible Years~     Series (IYS)). For this study, the outcome of engagement is operationally defined as~     intention to attend IYS sessions, attendance, and satisfaction with the IYS program.~      Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by~     the following moderators: parenting self-efficacy, child behavior problems, and maternal~     depression.~      The investigators hypothesize that the effect of MI on engagement will be greater among~     parents with lower parenting self-efficacy and parents of children with more behavior~     problems, but less among parents with more maternal depressive symptoms.~      The investigators will use a stratified, randomized controlled trial (RCT) design to~     evaluate the impact of MI on parent engagement in a well-validated preventive parenting~     skills intervention, the Incredible Years Series (IYS).~   "
84179|NCT01955538|"~     The aim of this randomised controlled trial is to study two types of physical activities as~     add-on treatment, compared to treatment as usual for traumatised refugees. Hereby, the study~     will examine the evidence of an often-used treatment modality in a field where very little~     research yet has been conducted.~   "
84180|NCT01955525|"~     This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of~     the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible~     associations with their cardiovascular profile and to ii) Linkage these data to multiple~     electronic healthcare records~   "
84182|NCT01955499|"~     This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib in~     treating patients with B-cell non-Hodgkin lymphoma that has returned or not responded to~     treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide with~     ibrutinib may work better in treating non-Hodgkin lymphoma.~   "
84183|NCT01955486|"~     The purpose of this study is to gather more information on Eustachian tube function and~     middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes~     inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight~     simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function~     will be monitored at various chamber pressures.~   "
84184|NCT01955473|"~     This is a Phase 1, open-label, dose-escalation trial to assess the safety and tolerability~     of Sym004, administered weekly or biweekly as monotherapy in Japanese subjects with advanced~     solid tumors.~   "
84185|NCT01955460|"~     This is a pilot study to assess the feasibility and safety of producing sufficient~     quantities of T-cells injected with the genes TGFb-DNR and NGFR that can be given in~     combination with chemotherapy (cyclophosphamide and fludarabine) and aldesleukin to patients~     with metastatic melanoma.~      This study involves gene therapy. T-cells are types of white blood cells that help your body~     fight infections. They may recognize and kill melanoma cells. Researchers want to grow your~     T-cells in a laboratory, inject them with TGFb-DNR and NGFR genes which may help them~     recognize tumor cells, and then give them back to you by vein. This may help to control~     melanoma.~   "
84186|NCT01955447|"~     The study is designed to determine the extent to which foods containing different levels of~     plant-based ingredients affect blood glucose responses in healthy subjects.~   "
84187|NCT01955434|"~     This phase II trial studies how well second mitochondrial-derived activator of caspases~     (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with~     multiple myeloma that has returned or does not respond to treatment. Biological therapies,~     such as SMAC mimetic LCL161, may stimulate the immune system in different ways and stop~     cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or~     with cyclophosphamide is more effective in treating multiple myeloma.~   "
84188|NCT01955421|"~     This study is a multicenter, randomized, open-label Phase II trial that compares reduced~     dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced~     non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease~     control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A~     total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or~     gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression.~     Independent assessment of the major endpoints will be completed in a treatment-blinded~     manner. Randomization will be stratified based on treatment-lines (first-line vs.~     maintenance vs. second-line therapy). Tumor response and progression will be assessed~     according to RECIST 1.1.~   "
84189|NCT01955408|"~     Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85%~     of patients with bladder cancer present with a disease that is confined to the mucosa or~     submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e.~     superficial tumors).~      Bladder cancer is the fifth most common cancer in the United States, with an estimated~     67,160 newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year~     survival rate is 82% for all stages combined. The standard of treatment for patients with~     superficial bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80%~     early success rate. However, nearly 70% of these patients will develop tumor recurrence,~     with 25% showing progression to muscle-invading disease, within 5 years with TUR.~      It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks~     of recurrence and progression do not always indicate the risk at which a certain therapy is~     optimal. The choice of therapy may be considered differently according to what risk is~     acceptable for the individual patient and the urologist.~      Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR,~     to prevent recurrence and progression of superficial disease. Systemic therapy is typically~     reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is~     an ideal organ for regional therapy.~      The urethra provides easy access of therapeutic agents to the urinary bladder. The presence~     of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits~     the absorption of molecules or particulates into the systemic circulation.~      The rationale for intravesical therapy is to maximize the exposure of tumors located in the~     bladder cavity to therapeutics agents while limiting the systemic exposure and thereby~     limiting the host toxicities; the primary goal is to eradicate existing or residual tumors~     through direct cytoablation or immunostimulation. The unique properties of the urinary~     bladder render it a fertile ground for evaluating novel approaches to regional therapy,~     including local hyperthermia, co-administration of permeation enhancers, bioadhesive~     carriers, and gene therapy.~      One of the developing treatments for high-risk superficial bladder cancers is the~     combination of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia~     (C-HT). The most common form of C-HT uses the Synergo HT system, in which local HT is~     administered via direct microwave irradiation of the urothelium by means of a 915-MHz~     intravesical microwave applicator. The target intravesical temperature is set between 41.8C~     and 44.8C and is measured by five thermocouples integrated in a 20-F treatment catheter. To~     avoid injury, the urethra is continuously cooled. Due to extensive global experience with~     its use and a significant amount of preclinical data demonstrating improved antineoplastic~     efficacy when heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent~     used in conjunction with HT.~      The most common adverse events during treatment were bladder spasms and bladder pain.~     Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder~     spasms tended to occur more frequently with the prophylactic schedule, whereas pain was~     present equally in the prophylactic and ablative schedules but more commonly after the~     ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria,~     urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most~     studies mention that these symptoms were mild and transient, resolving spontaneously within~     a few days of treatment. One study described severe cystitis complaints in three patients~     (16%), but other studies have not confirmed these adverse events. Two studies report the~     development of a contracted bladder and severe urinary incontinence after ablative C-HT.~     However, the possibility cannot be excluded that previous transurethral resection and~     intravesical chemotherapy might have contributed to this event.~      Following the appearance of bothersome storage LUTS, patient should be managed by existing~     guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic)~     in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated~     according to the suggested algorithm.~      In our study, we would like to assess the severity of OAB symptoms and their response to a~     standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to~     assess urodynamic study variables in those who didn't respond to a standard medical~     treatment and bothered by their OAB symptoms.~   "
84190|NCT01955395|"~     This research study is evaluating the effects of a mind body medicine intervention called~     the Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in~     patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering~     multiple myeloma (SMM).~      This research study is a supportive care trial. This means that the intervention program may~     improve general well-being and comfort, but is not considered a treatment or cure for MGUS~     or SMM. It is considered an investigational intervention because the investigators are~     examining the effectiveness of a new program - the 3RP - on reducing stress and~     stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM~     involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the~     National Institutes of Health, focuses on the interactions among the brain, mind, body, and~     behavior, and on the powerful ways in which emotional, mental, social, spiritual, and~     behavioral factors can directly affect health. The 3RP is a newly designed group therapy~     program that through a variety of mind body principles and self-care interventions seeks to~     buffer stress and promote psychological resiliency and physical well-being.~      This study will examine the effectiveness of the 3RP in reducing stress and symptoms~     associated with stress in patients diagnosed with MGUS or SMM. Data from this study will~     also be used to assess changes in gene expression that result from 3RP intervention,~     particularly genetic pathways that are known to be dysregulated in MM.~   "
84191|NCT01955382|"~     Background:~      - Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if~     an infected mosquito bites them. Malaria destroys red blood cells. Most malaria is mild, but~     some children develop severe malaria, which kills about 660,000 people annually. About 9 in~     10 who die of malaria are Sub-Saharan African children, most under 5 years old. Scientists~     can save many lives if they find out how to prevent or relieve severe malaria.~      Objective:~      - To know if a common medicine called activated charcoal can reduce severe malaria symptoms.~      Eligibility:~      - Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali.~      Design:~        -  For the first 2 days and nights, participants will stay in the hospital.~        -  They will have their medical history taken, and a physical exam.~        -  Blood will be drawn from a thin tube inserted in their hand or forearm. This will be~          done 3 times overall. A drop of blood will be taken from a finger prick 12 times~          overall.~        -  An antimalarial drug will be injected into the tube in the arm 4 times. Each time the~          drug is given, participants will drink a small cup of either water or activated~          charcoal.~        -  For the following 3 days, participants will take an antimalarial pill.~        -  On day 7, participants will visit the hospital. A drop of blood from a finger prick~          will be tested for malaria parasites.~   "
84192|NCT01955369|"~     There is a lack of prospective and population-based epidemiological data on amyotrophic~     lateral sclerosis in Germany so far. The purpose of this registry is to investigate the~     incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German~     state of about 4 million inhabitants.~   "
84195|NCT01955330|"~     OBJECTIVES:~      The objectives of the year study are two-fold:~        1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft~          and stent of patients who have already had robotically-assisted Hybrid CABG surgery~          using CTA and MPS-MIBI.~        2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid~          CABG surgery~   "
84196|NCT01955317|"~     Background (brief):~        1. Burden:~           Neonatal death still unacceptably high in low income countries. The common causes of~          neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur~          because the mother's hands or the hands of the person who attended the birth are~          unclean. Our previous study found that there was substantial concern about excessive~          exposure of the mother or the neonate to water during handwashing because of the~          perception that frequent contact with water could lead to respiratory illness.~        2. Knowledge gap:~           Chlorhexidine has been evaluated for use in hand hygiene applications in high-income~          countries, particularly in healthcare, but it has not been evaluated or promoted for~          hand cleansing at the household level in low- and middle-income countries.~        3. Relevance:~      A waterless hand cleanser employing chlorhexidine would overcome important barriers to~     handwashing with soap, perceptions of cold resulting from exposure to water, and the time~     limitations perceived by mothers.~      Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention~     will clean their hands (with chlorhexidine or soap and water) more frequently than mothers~     who are not exposed to the chlorhexidine-based hand cleansing program.~      Objectives:~      The primary objective~        1. To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention~          on hand cleansing of mothers during the neonatal period The secondary objectives~        2. To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand~          cleansing of other family members, visitors to the neonate, and birth attendants during~          the neonatal period~        3. To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal~          period among mothers, other family members, and birth attendants~      Methods:~      We propose a randomized controlled trial in a rural area of Bangladesh, with an active~     control. Randomization will be at the level of the participating pregnant woman. Each arm~     will include 150 participants. All intervention visits will follow baseline data collection.~     A trained health and hygiene promoter will carry out two visits in the antenatal period and~     one postnatal visit to deliver intervention messages.~      Outcome measures:~        1. Observed hand cleansing behavior of mother with chlorhexidine or soap and water at~          critical times.~        2. Observed hand cleansing behavior of other household members and visitors to home with~          chlorhexidine or soap and water at critical times.~   "
84197|NCT01955304|"~     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose~     of 4mg fruquintinib in normal healthy subjects.~   "
84198|NCT01955291|"~     The aims of the study is to explore whether the rehabilitation of the upper extremity~     performed in interaction with a virtual environment could improve motor function in~     post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the~     traditional neuromotor rehabilitation treatment.~   "
84199|NCT01955278|"~     Introduction Parastomal hernia is the most common complication related to colostomies. The~     variability of the diagnostic criteria, the fallow up time and sometimes subclinical~     dimensions, detectable only with imaging, explain disparate figures cited in the literature~     (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors~     consider that actually, almost all patients present parastomal hernia in the long-term~     fallow up (3).~      Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing~     since the beginning the weak peristomal area of the abdominal wall. Existing scientific~     evidence, although positive, is limited and does not allow to clarify some controversial~     issues as the type of prosthetic mesh to be used and the optimal position of the mesh in~     relation to the abdominal wall (4-8).~      The use of laparoscopic approach in colorectal surgery is increasing and also sets technical~     changes to the placement of the mesh. To date, there are some technical notes (9) and two~     published prospective, observational studies that include patients underwent laparoscopic~     surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11)~     is used, with encouraging short-term results, but they need more scientific support.~      Study Design This is a prospective, randomized, single center, clinical study where the~     sample is represented by patients undergoing elective laparoscopy assisted colorectal~     surgery, with the creation of a permanent end colostomy. Patients who accept to participate~     and are suitable for inclusion to the study will be randomized into one of the two branches~     consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive~     end colostomy reinforced by retromuscular mesh Ultrapro.~      Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent~     parastomal hernia end colostomy versus realization of end colostomy by conventional~     technique.~      Primary Objective: Compare the incidence of parastomal hernias between groups during the~     monitoring period.~      Secondary objectives: Compare the overall and specific postoperative morbidity and mortality~     between groups, compare the difference in surgical time between the conventional technique~     and the prosthetic mesh group, compare hospital stay between the groups.~   "
84200|NCT01955265|"~     Background~      A physically active lifestyle is crucial for development but a large number of youth in Hong~     Kong are sedentary and do not meet the International (World Health Organisation) and the~     local (Leisure and Cultural Services Department) recommendation for physical activity. On~     the other hand, the evidence for implementing positive youth development programme through~     physical activity and sports is elusive.~      Purpose~      This study aimed to promote physical activity and sports amongst adolescents in Hong Kong~     through a structured sports mentorship intervention. The study also aimed to investigate the~     effect of such programme in positive youth development.~      Methods~      This was a two-phased study with Phase I being the preparatory stage and Phase II being the~     implementation stage. In Phase I, questionnaire surveys and focus group interviews were~     conducted to understand the relevant perceptions and opinions amongst various stakeholders~     (e.g. teachers, parents, and students). The data collected was analysed to inform the design~     and planning of the Phase II intervention. Phase II was an experimental trial of our sports~     mentorship programme. Participating students were divided into intervention and control~     group, where the former received the sports mentorship programme and the later did not. The~     intervention was 18 weeks long providing an additional 90 minutes of active time per week~     for all students in the intervention group. Programme mentors were trained and supported in~     reference to previous evidence. Intervention effectiveness were evaluated by comparing the~     outcomes between intervention and control group.~   "
84201|NCT01955252|"~     The trial that the investigators are proposing is a pilot study to determine the effect of~     the new WHO-yaws eradication strategy in Lihir Island (population 18,000), Papua New Guinea.~     New treatment policies were developed by WHO in 2012 to replace those of the 1950s. The~     recommended practice is to offer an initial MDA with azithromycin to the entire population,~     followed by resurveys every 6 months to detect and treat remaining cases.We will use~     serology surveys, clinical surveys and ulcer aetiology studies to measure the effect of mass~     azithromycin treatment on the community burden of yaws infection.~   "
84202|NCT01955239|"~     Rationale:~      Radiation-induced parotid gland dysfunction, often leading to xerostomia is the~     most-frequently occurring side-effect with a major impact on patient-reported quality of~     life after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are~     currently optimized to minimize the mean dose to the parotid glands. Though this resulted in~     a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid~     gland dysfunction and xerostomia.~      However, in animal studies the investigators found that the dose to the sub-volume of the~     gland containing the parotid gland stem cells is a better predictor for dysfunction than the~     mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective~     analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the~     parotid glands of patients is expected to further reduce the risk of parotid gland~     dysfunction and xerostomia.~      Objective:~      To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy~     in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to~     conventional parotid gland sparing intensity modulated radiotherapy.~      Study design:~      Double-blind prospective randomized trial (51 patients per arm). Study population: Patients~     treated for tumours in the head-and-neck region with curative radiotherapy, with or without~     the addition of chemotherapy or cetuximab.~      Intervention: Patients randomized into the experimental arm will receive a treatment in~     which the radiation dose to the parotid gland is re-distributed to minimize dose to the~     sub-volume containing the stem cells, while keeping the same mean dose to the parotid gland~     as a whole.~      Main study parameters/endpoints:~      Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and~     physician-rated xerostomia.~   "
84203|NCT01955226|"~     The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the~     number of unscheduled central catheter dressing changes compared to standard clear Tegaderm~     IV dressing in pediatric patients between the ages of 2 months to 18 years with central~     venous access. Secondarily, we will monitor contact skin irritation and central line~     associated blood stream infections.~   "
84204|NCT01955213|"~     Methylnaltrexone for the treatment of opioid-induced constipation in the setting of~     palliative or hospice care, is significantly more effective than placebo (1). However, in~     both the randomized and the open-label phase of the multi center trial showing this~     favorable outcome, the drug produced rescue-free laxation in only about half of the patients~     (2). There may be several reasons for this result, since constipation in palliative care~     patients often has multiple simultaneously occurring causes.~      Assuming that constipation of the non-responders is still opioid-induced, one of the~     possible reasons for not responding to methylnaltrexone could be that central actions of~     opioids contribute to constipation by reducing motility of the intestines through direct~     actions in the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor~     antagonist and not all opioids are solely µ-receptor agonists another reason may well be~     that successful laxation is determined by the receptor-profile of the specific opioid the~     patient is using.~      Opioids do not only influence bowel functioning, but also immune system functioning and~     angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will~     also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.~   "
84205|NCT01955200|"~     The purpose of this study is to determine that for patients who received stent implantation~     but present low response to regular anti-platelet treatment, whether 1-month intensified~     anti-platelet treatment by replacing clopidogrel with ticagrelor (TCL) is superior to double~     dose clopidogrel or adding cilostazol.~   "
84206|NCT01955187|"~     In this study, investigators will evaluated the long-term efficacy and safety (two years) of~     Tacrolimus-Rituximab (RTX) therapy compared to Methylprednisolone-Cyclophosphamide (CYC)~     therapy in patients with primary Membranous Nephropathy (MN).~      PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a~     greater increase in the proportion of primary MN patients with Complete or Partial Remission~     when compared with patients receiving standard treatment. It will be assessed 24 months~     after the beginning of treatment.~      Phase of the trial: and design: Phase III study, open label, randomized, and active~     controlled trial.~      This study will have 3 stages: screening and recruitment of patients for 18 months,~     treatment period for six months in corticosteroids plus CYC group and 9 months in~     Tacrolimus-RTX group, and finally post-treatment follow-up period until to complete 24~     months of follow-up since initial treatment.~      This study will compare the standard therapy for primary MN patients with nephrotic range~     proteinuria (active control of steroids plus CYC) with a novel sequential therapy of~     tacrolimus and RTX, an approach of potential high efficacy, low toxicity and more acceptable~     safety profile.~   "
84207|NCT01955174|"~     This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of~     botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to~     hypercontractile esophageal motility disorders.~   "
84208|NCT01955161|"~     To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic~     treatment of patients with mild-to-moderate Alzheimer's disease (AD).~   "
84209|NCT01955148|"~     This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can~     be used to advance prediction of spontaneous preterm birth (sPTB). This will be a~     prospective observational multi-center study with approximately 15 to 20 US sites, and~     approximately 1210 subjects evaluating the clinical utility of the Rapid fFN 10Q system for~     preterm birth risk assessment. A single fFN specimen will be collected from each subject~     between 16 weeks, 0 days and 21 weeks, 6 days. The primary and secondary maternal outcome~     measures will be determined based on the date of delivery and the estimated date of~     confinement (EDC), which will be evaluated in a standardized manner.~   "
84210|NCT01955135|"~     Premature infants experience more respiratory problems after surgical procedures. The~     investigators aimed to compare general anesthesia with sedation on the need for~     post-operative mechanical ventilation in infants undergoing retinopathy of prematurity~     surgery.~   "
84211|NCT01955122|"~     To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard~     view colonoscopy.~      To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard~     view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal~     and overall procedure time will be analyzed and reported for each group.~   "
84212|NCT01955109|"~     The objectives of this open-label follow-up study for subjects who previously were~     randomized and have completed the VIPES study for the treatment of peanut allergy, are:~        -  To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.~        -  To evaluate the safety of long-term treatment with Viaskin Peanut.~        -  To evaluate sustained unresponsiveness to peanut after a period of 2 months without~          treatment in subjects showing desensitization to peanut after treatment with Viaskin~          Peanut.~   "
84213|NCT01955096|"~     The purpose of this study is to to investigate the feasibility and safety of fast-track~     surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer~     patients.~   "
84223|NCT01954966|"~     The purpose of this study is to learn whether a sex hormone called progesterone is helpful~     in reducing cigarette smoking and craving for cigarettes. This study also includes brain~     imaging to measure possible effects of progesterone on certain neurochemicals. These~     neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both~     nicotine and progesterone affect these brain chemicals.~      Individuals wishing to participate in this study must be medically healthy men or women who~     smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental~     illness or use drugs other than nicotine. Participants cannot have any implanted metallic~     devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have~     peanut allergies and must never have had a reaction to progesterone. Finally, participants~     cannot be taking any medications for anxiety, depression or insomnia.~      Women: Female participants cannot have taken a hormonal contraceptive in the past six~     months.~   "
84739|NCT01948219|"~     The objective of this clinical study is to evaluate the feasibility, safety and efficacy of~     the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.~   "
84214|NCT01955083|"~     1. Background：The methods of anti-snore (treatment of snoring ) can be divided into~          conservative, invasive and minimal invasive treatment. IN brief, minimal invasive~          surgery involving radiofrequency and pillar implant demonstrates significantly~          improvement of snoring without major complication. Previous studies usually evaluated~          snoring through subjective measures such as visual analog scale visual analog scale.~          Rare reports analyzed snore sound instrumentally and no report demonstrates the~          correlation between subjective perception and objective assessment of snoring before~          and after surgical intervention.~        2. Purposes：~             1. Development of snore sound spectrum.~             2. Exploration of the correlation between subjective perception and objective~               assessment of snoring.~             3. Comparison of changes in snoring before and after minimal invasive surgery and~               between two kinds of MIS to have a understanding of surgical impact in subjective~               and objective measurement.~        3. Method：We plan to enroll 30 subjects diagnosed by polysomnography as simple snoring or~          mild OSA with major complaint of snoring and favorable anatomic structure for minimal~          invasive surgery. All eligible subjects will be instructed the purpose, process and all~          related rights of this study and sign inform consent in outpatient clinic. Subjects~          start to complete Snore Outcome Survey (SOS, a validated questionnaire) and visual~          analog sure of snoring (VAS). Objective overnight snore sound recoding is arranged in~          sleep center. Subjects then receive minimal invasive surgery：radiofrequency or pillar~          implant of the soft palate by randomization. Both radiofrequency and pillar implant are~          common techniques in treating snoring and performed under local anesthesia as an~          outpatient procedure on sitting position. All subjects received repeated snore sound~          recording and completion of SOS and VAS three months after MIS.~        4. Outcomes~             1. Development of snore sound spectrum in sleep-disorder breathing patients.~             2. Correlation of parameters between snore sound recording (loudness, frequency,~               count, regularity, etc ) and clinical parameters.~             3. Correlation between objective (snore sound analysis) and subjective (SOS,VAS)~               assessment of snoring.~             4. Comparison of changes in snoring (particular in objective assessment) after~               radiofrequency or pillar implant.~             5. Comparison of changes in snoring between radiofrequency and pillar implant.~   "
84215|NCT01955070|"~     This is a prospective cohort study in which the standard verbal informed consent process for~     ketamine sedation is compared to a multimedia informed consent process. The goals include~     determining if parents prefer a multimedia consent process and evaluating the effectiveness~     of multimedia consent process.~   "
84216|NCT01955057|"~     Persistent smoking after lung cancer has been the subject of medical, therapeutic and~     epidemiological publications for twenty years of research. Continued persistent smoking is~     all the more a problem for oncologists as there is evidence that smoking cessation, with~     lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to~     treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival.~     However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the~     hypothesis that adhesion differences aren't related to the denial of medical information,~     nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a~     form of impossibility to wean. Cigarette seems to be felt as a part of their body in their~     narration and description of their body image.~   "
84217|NCT01955044|"~     The purpose of this study is to determine if buccal administration of a concentrated~     formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain~     docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.~   "
84218|NCT01955031|"~     Severity of diabetes is related to the development of disabling and costly complications~     (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic~     education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes~     Mellitus. Despite these recommendations, patients often have difficulties to implement~     dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes~     to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic~     complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring~     program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of~     the patients. It is expected that our program leads to a better monitoring of health status,~     a greater adherence to medical and non-medical prescriptions, an empowerment of the patient,~     and as a consequence, a more efficient health care consumption.~   "
84219|NCT01955018|"~     Asbestos fibers were intensively used throughout the 20th century and remain prevalent in~     developing countries. However, asbestos exposure induces a variety of benign and malignant~     pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer.~     Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for~     detecting early asbestos-related conditions. Increased exposure to radiation underpins the~     consequences of cancer induction. However, reducing CT doses increases image noise from the~     filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure~     include the use of iterative reconstruction algorithms. A new algorithm called VeoTM~     (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70%~     compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with~     excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to~     0.3 mGy.~      The objective of the present study is to compare Veo with the gold standard FBP for~     detecting pulmonary asbestos-related conditions among workers previously exposed to~     asbestos. Comparisons included radiation delivered and image quality.~   "
84220|NCT01955005|"~     This study aims to conduct a pilot of an intervention to improve care coordination between~     VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health~     record, My HealtheVet (MHV). Participants will be randomized to receive either training on~     1) how to use My HealtheVet to share VA health information or 2) training on how to how to~     search the Internet for health information and decide which Internet sites have good quality~     information. The investigators predict that Veterans who receive the My HealtheVet training~     will have fewer medication errors and duplication of services between the VA and outside~     providers.~   "
84221|NCT01954992|"~     The study is designed to assess whether glufosfamide provides additional survival benefit as~     compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already~     progressed or failed therapy on a gemcitabine based first line regimen.~   "
84222|NCT01954979|"~     The participant is invited to take part in this study because they have chronic Graft versus~     Host Disease (cGVHD) that is not responding to standard treatment with steroids. This~     research study is a way of gaining new knowledge about the treatment of patients with cGVHD.~     This research study is evaluating a drug called abatacept.~      Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by~     the Food and Drug Administration (FDA) for the treatment of moderate to severe active~     rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients~     who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These~     are autoimmune conditions, ie caused by an overactive immune system that attacks normal~     tissues and organs. It is currently being tested in a variety of other autoimmune~     conditions. In this case it is considered experimental.~      cGVHD is caused by the donor cells attacking various organs of the recipient. The~     investigators try to minimize this immune attack by using corticosteroids such as~     prednisone. In severe cases prednisone is not sufficient and other immunosuppressive~     medications are used in addition in order to more efficiently control cGVHD and to limit the~     dose and consequently the multiple side-effects of corticosteroids. This study is being done~     to determine if the use of abatacept is safe in patients with cGVHD and if it can facilitate~     a better control of cGVHD.~      During this study the participants will be evaluated for side effects from the treatment~     with abatacept, and for response of the cGVHD to the treatment. There will be two groups of~     participants in the study. The first group will be treated at a relatively low dose of~     abatacept. If this is found to be safe then the second group will be treated at a higher~     dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to~     determine your blood counts, kidney and liver function. Some of the blood will be used in a~     research lab in order to study measures of your immune system and how they might be affected~     by the treatment.~   "
84224|NCT01954953|"~     This study aims to characterize Usher patients in order to correlate this data with genetic~     information.~      Tasks:~        -  Standardization and improvement of Usher syndrome diagnosis: refine and elaborate~          special tests of visual and otological function in association with genotype that~          enable to determine the most significant markers for Usher disease progression and~          therapeutic effect.~        -  Perform genotype and phenotype correlations in Usher syndrome patients~        -  Develop and maintain database for phenotypically and genotypically well-characterized~          patient cohorts, suitable for future therapeutic trials~   "
84225|NCT01954940|"~     Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at~     improving muscle strength and endurance as well as bone density. It holds promise for~     children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle~     weakness results not only from muscle breakdown but also physical inactivity and muscle~     disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear~     of falling or loss of independence (e.g. difficulty rising to stand without assistance).~     Prolonging the length of time boys with DMD are ambulatory is important for delaying~     complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone~     health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular~     dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in~     this patient population. The secondary outcomes will evaluate changes in muscle strength and~     endurance. Bone health will also be examined as part of routine clinical care. The study~     will include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into~     2 groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of~     10 boys undergoing daily WBVT in an 8-week, open-label trial.~   "
84226|NCT01954927|"~     This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of~     gabapentin when added to standard pain management for patients with sickle cell disease~     experiencing acute pain crisis in the ambulatory care setting.~      Sickle cell pain is different for every patient. Some patients get complete relief from~     routine pain medicines, and others need more time or more doses of pain medicines before the~     pain goes away completely. It is known that humans have many types of pain, including~     something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)~     has been treated successfully with a medicine called gabapentin. The investigators in this~     study suspect that some sickle cell pain is a combination of pain types. They would like to~     see if adding gabapentin to the usual pain medicines makes pain go away faster or more~     completely.~      Primary Objective:~        -  To assess the analgesic efficacy of gabapentin vs. placebo for pain during~          vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response~          to study drug will be defined by a decrease in pain score of ≥ 33% between presentation~          to the acute care setting and assessment at 3 hours post administration of study drug.~      Secondary Objective:~        -  To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC~          between presentation to the acute care setting and assessment at 3 hours post~          administration of study drug in the gabapentin vs. placebo groups.~   "
84227|NCT01954914|"~     With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does~     not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are~     therefore called poor mobilizers. A generally accepted optimum CD34+ PBSC dose for~     allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total~     CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective~     of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure~     in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of~     peripheral blood stem cell collection.~   "
84228|NCT01954901|"~     The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT)~     plus standard wound care is more effective than standard wound care alone in the rate of~     healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2~     diabetic lower extremity ulcers.~   "
84229|NCT01954888|"~     The first purpose of this study is to compare the effectiveness of the stellate ganglion~     block realized with two different approaches (blind and ultrasound-guided) in patients with~     a diagnosis of complex regional pain syndrome.~      The second purpose of this study is to determine the safest approach and to compare the~     safety profiles of the two approaches.~   "
84230|NCT01954875|"~     The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the~     role of infection in the gastrointestinal tract in the etiology and pathogenesis of~     neurological diseases such as idiopathic Parkinson. For example, infection with Helicobacter~     pylori has been suggested to play a role in Parkinson disease. In addition, bacterial~     pathogens such as spirochetes and bacterial products such as cyanobacterial toxins have been~     speculated as the contributing factors in the development of amyotrophic lateral sclerosis~     (ALS). The effect of microbial composition of the gut in the pathogenesis of ALS is~     suspected. The difference in the bacterial profile of the gut has been documented in~     diseases such as inflammatory bowel disease and obesity.~      The goal of this IRB protocol is to create a human tissue bank and to obtain patients'~     demographic information for future investigation of the role of bacterial pathogens and the~     role of gut flora composition in the development of neurodegenerative diseases including but~     not limited to ALS, Parkinson's disease, and multiple sclerosis.~   "
84231|NCT01954862|"~     Insufflation of the colon, usually with room air, is necessary to distend the lumen for~     exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has~     been shown to decrease symptoms of abdominal pain or discomfort during the procedure and~     particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal~     mucosa and exhaled through respiration. AI colonoscopy has usually been the reference~     standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was~     compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails~     infusion of water to facilitate insertion to the cecum.~      WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water~     is infused during the insertion phase of colonoscopy, with removal of infused water~     predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails~     complete exclusion of insufflation, removal of residual colonic air pockets and feces, and~     suction of infused water predominantly during insertion to minimize distention. During the~     withdrawal phase insufflation is used to distend the colonic lumen.~      In the WAC arms of the two mentioned articles the insertion method used was WI, with~     infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or~     either air or CO2 insufflation were employed.~      Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation~     during withdrawal) were effective in both studies in decreasing sedation requirement, pain~     and tolerance scores, with patients' higher willingness to repeat the procedure.~      Until now no direct comparison has been made within a single study about pain score during~     colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.~      In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI~     methods will decrease pain score during colonoscopy, with reduction of sedation requirement,~     and that WE will achieve the best result. This comparative study has also the aim to test~     the respective peculiarities of each method.~   "
84232|NCT01954849|"~     This study investigates the efficacy of a proprietary probiotic formulation comprising 6~     strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11~     and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a~     prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this~     study will be randomly assigned to receive either the probiotic treatment or a placebo, both~     in the form of a dissolving lozenge; for which the placebo is exactly the same shape,~     texture, taste, and composition as the probiotic treatment, but does not contain the active~     probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen~     for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores,~     plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28~     days. They will also be assessed for the same measures at day 56, following a 28-day~     wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro~     analyses of changes in microbial pathogens and/or inflammatory cytokines.~   "
84233|NCT01954836|"~     Hypothesis: Fasting before (48h) and one day after chemotherapy may protect normal cells~     from the adverse effects of chemotherapy. Design: Within a randomized controlled pilot trial~     30 female patients with gynecological cancer (ovarian and breast cancer)and 4-6 scheduled~     chemotherapies will be randomized to fast 60-72 hours during the first half of~     chemotherapies or during the second half of chemotherapies and to proceed normocaloric food~     intake during the other cycles.Sequence of fasting and normocaloric food intake will be~     randomized. Assessments of adverse effects, quality of life and laboratory values take place~     24 and 7 days after each chemotherapy. Statistical analyses compare summarized differences~     of fasted and non-fasted chemotherapy cycles.~   "
84234|NCT01954823|"~     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young~     adults, with onset usually at the age 20-40. Disease modifying therapies are available to~     MS, as well as drugs to improve patients' symptoms.~      Choosing the optimized treatment for each patient is a challenge to neurologists since~     predictive biomarkers for therapy are yet to be validated and approved. Current therapy~     decisions are based predominantly on clinical evaluation of disability and disease relapses.~     Adherence to treatment in MS is sub-optimal.~      Over the past few years a growing involvement of patients in their healthcare is noted,~     specially in chronic diseases, and Patient Reported Outcomes (PRO) are being incorporated as~     part of therapy evaluation.~      Several electronic patients diaries to track adherence to therapy, PRO and drugs side~     effects in diseases such as epilepsy are available. A mobile interactive patient diary~     (e-diary) tailored for persons with MS was developed. Users can enter data on drugs intake,~     drugs-side effects and disease symptoms and receive reminders regarding adherence to~     treatment.~      The aim of this study is to assess the benefits of the use of an e-diary for MS patients on~     healthcare. In order to achieve this goal, 80 MS patients will be randomized into two~     groups: a study group with access to the e-diary and a control group. After a period of one~     year, satisfaction with the e-diary will be assessed. The effect of the use of the e-diary~     on quality of life, on clinical outcomes and on adherence to therapy will be evaluated by~     comparing the two groups.~      This study will indicate the possible contribution of an e-diary for the evaluation of drugs~     safety and efficacy and of patient adherence to therapy, to be applied in clinical trials~     and towards improvement of MS patient' care.~   "
84235|NCT01954810|"~     This study has aim to describe the immune response to the second dose of Japanese~     encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV~     5 years ago.~   "
84236|NCT01954797|"~     The purpose of this observational study is to examine the effects of 4-weeks of physical~     fitness training in patients with subacute ischemic stroke on cerebral imaging and~     blood-derived biomarkers.~   "
84237|NCT01954784|"~     This phase I trial studies the side effects and best dose of lenalidomide after donor stem~     cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving~     low doses of chemotherapy and total-body irradiation before a donor stem cell transplant~     helps stop the growth of cancer cells. It may also the patient's immune system from~     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving a bortezomib at the time of transplant may stop this from happening.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different~     ways and stop cancer cells from growing. Giving lenalidomide after donor stem cell~     transplant may be an effective treatment for multiple myeloma.~   "
84238|NCT01954771|"~     Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in~     diabetes management. Multiple times of blood glucose measurements by fingerstick in the same~     day are of tough challenge to it. The changes and variations of glucose excursion in senior~     diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated~     hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for~     precisely monitoring and predicting glycemic excursion, variability in senior type 2~     diabetics with CAD.~   "
84239|NCT01954758|"~     This project seeks to demonstrate the clinical value of the personalised diagnosis of the~     endometrial factor in infertility.~   "
84240|NCT01954745|"~     This research study is evaluating a drug called cabozantinib as a possible treatment cancer~     of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of~     the body. By blocking the c-MET and VEGFR2 pathways from sending signals, cabozantinib may~     prevent cells from multiplying. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to stop the~     growth of bile duct cancer.~      In this research study, the investigators are looking to see how well cabozantinib works in~     slowing the growth of bile duct cancer. The investigators are also assessing the safety and~     tolerability of cabozantinib in participants with this type of cancer.~   "
84241|NCT01954732|"~     This randomized clinical trial studies metformin hydrochloride in treating patients with~     pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
84242|NCT01954719|"~     The purpose of this prospective randomised study was to determine the effect of routine~     cervical dilatation during elective caesarean section on maternal morbidity~   "
84243|NCT01954706|"~     Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women,~     and drug therapies, which block the production or effects of estrogen, are the mainstay of~     treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase~     inhibitors (AIs) are the standard of care for long-term estrogen suppression in these~     patients. Estrogen deficiency, however, results in multiple side effects. Some of the most~     common side effects in women taking AIs are joint and muscle aches, which promote physical~     deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients~     and the improvements in cancer-related outcomes that are observed with their use,~     identifying methods to reduce these side effects to maintain adherence to treatment is~     important. Exercise interventions in breast cancer patients also improve quality of life and~     reduce fatigue. Understanding the role of exercise in AI side effect prevention will allow~     us to translate these findings into therapy guidelines.~   "
84244|NCT01954693|"~     This is a single centre, two-arm, individually randomised, Phase II, double- blind,~     placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of~     neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed~     medicine in this patient group but for a different target of effect. The current trial is a~     proof of principle study for memory and executive function outcomes.~      Following an eligibility visit, patients will be scheduled for baseline visit and~     randomization. They will then be followed up for 6 months undergoing both safety and~     neurocognitive assessments whilst taking either the placebo or study drug.~      48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ > 60 and a~     significant deficit in one or more primary outcome measures will be randomly allocated in a~     ratio of 2:1 to either RAD001 (Everolimus) or Placebo.~   "
84245|NCT01954680|"~     The main aim of this study is to test a new, non-medication computer-based potential~     treatment for bipolar disorder in children and adolescents.~      In the study, children and adolescents with bipolar disorder will come to our lab at Bradley~     Hospital 2-times per week for 8-weeks to play a custom computer game designed to retrain~     the brain--to build a skill that my work has shown is impaired in children/adolescents with~     bipolar disorder.~      Before and after this 8-week trial, children will have a special magnetic resonance imaging~     (MRI) scan.~      This is a test of feasibility--meaning we want to see if the 8-week trial results in brain~     changes.~      If it does, we will conduct a second study to see if it improves how bipolar children~     function--i.e., if it helps their illness.~   "
84246|NCT01954667|"~     evaluate the impact of different anthropometric measures on clinical and endoscopic severity~     of GERD and its relation to serum leptin.~   "
84247|NCT01954654|"~     The purpose of this study is to determine whether accelerated treatment with custom-made~     compression sleeve is more effective than standard procedure in the treatment of mild and~     moderate arm lymphedema secondary to primary cancer treatment.~   "
84248|NCT01954641|"~     Purpose: African American cancer patients, as compared to their White counterparts, continue~     to initiate treatment later and remain less apt to undergo complete treatment; fueling worse~     treatment outcomes including shorter survival. The concepts of transparency and~     accountability, as mechanisms of systems change have been applied for decades by~     anti-racism organizations to civil rights and social change. Yet, the application of these~     concepts to health systems' change and unequal treatment has rarely been done. The~     Greensboro Health Disparities Collaborative and two Cancer Centers have joined together to~     specify structures built into cancer care systems that make cancer care vulnerable to~     institutional racism and investigate how they can be changed to reduce racial inequity in~     quality and completion of treatment for Stage 1-2 breast and lung cancer patients.~      Participants: White and African American patients with first diagnosis of Stage 1-2 breast~     and lung cancer, with intention to treat, and their cancer care staff at 2 cancer centers.~     The 2 cancer centers are Cone Health Cancer Center (CHCC) in Greensboro, North Carolina and~     the University of Pittsburgh Medical Center (UPMC) Hillman Comprehensive Cancer Center in~     Pittsburgh, Pennsylvania.~      Procedures (methods): Using a 5-year interrupted time-series, with an embedded randomized~     control trial (RCT) study design, we will test the effectiveness of the ACCURE intervention~     components. Having received Institutional Review Board approval for Phase 1, we completed a~     5-year, retrospective review of de-identified Electronic Medical Record data to establish a~     baseline of repeated outcome measures, convening of an expert committee to design the~     intervention, and design of the real-time, electronic breast and lung cancer registry~     coupled with dummy testing of the registry system.~      The randomized trial will compare patients who receive usual care to those who receive~     visits and calls from a trained ACCURE Navigator, who is well versed in issues specific to~     breast and lung cancer and trained to serve as a two-way communication bridge to optimize~     the cancer care system's accountability and transparency for equity in quality of care.~     Given unintended, but likely variation in implementation of the ACCURE intervention by the~     two Cancer Centers (at our two research sites), 6 elements of implementation and their~     potential effect on outcomes will be documented through a process evaluation.~   "
84249|NCT01954628|"~     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo in subjects following~     exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src~     Homology 2-containing Inositol-5'-Phosphatase 1) pathway.~   "
84250|NCT01954615|"~     Study Part I is a single-ascending dose study. Healthy male subjects to be included in the~     study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects~     per group, 6 subjects receive the investigational drug and 2 subjects receive matching~     placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male~     subjects to be enrolled in one group (Group G). Each subject to receive 2 different~     formulations of the prodrug and one formulation of the active drug in a randomized sequence.~   "
84251|NCT01954602|"~     The specific goal of this study is to compare the deep biliary cannulation rate and~     complication rates associated with use of touch and no touch guide-wire biliary cannulation~     techniques.~   "
84252|NCT01954589|"~     A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and~     pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor~     antagonist in healthy male subjects.~   "
84253|NCT01954576|"~     This pilot phase II trial studies how well Novocure's Tumor Treating Electric Fields~     (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme. NovoTTF~     therapy uses a low intensity electric current to kill tumor cells. NovoTTF therapy may be~     effective treatment for brain cancer.~   "
84254|NCT01954563|"~     Boost vaccinations sometimes have no effect because the body has got used to the vaccine and~     no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised~     MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination~     (or vice versa) avoids this and increases the immune response to vaccination.~   "
84288|NCT01954121|"~     To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine~     Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese~     population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset~     Seizures (POS).~   "
84255|NCT01954550|"~     This randomized controlled trial (RCT) will investigate the effects of a 6-month,~     individualized, moderate-intensity cycling intervention on cognition and hippocampal volume~     in AD with three aims:~        -  Determine the immediate effect of the cycling intervention on cognition in AD.~        -  Examine if the cycling intervention slows cognitive decline in AD from baseline to 12~          months.~        -  Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using~          MRI.~      The investigators will randomize 90 participants to the 6-month cycling or stretching/range~     of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for~     another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and~     hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6,~     and 12 months.~   "
84256|NCT01954537|"~     To collect field data in professional, collegiate, and high school football players to~     determine how they respond physiologically to the rigors of preseason training environment.~     Investigators will compare core temperature, hydration status, practice guidelines regarding~     rest and hydration, and baseline knowledge of heat illness and hydration among the three~     levels. The hypothesis is higher peak temperatures will be observed in the younger less~     experienced football players.~   "
84257|NCT01954524|"~     Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in~     patients with moderate to severe cirrhosis and kidney disease will be determined.~   "
84258|NCT01954511|"~     The objective of this study was to investigate the effect of a manual therapy and exercise~     program, focused on the rehabilitation of cervical function, on clinical signs and~     mandibular function in subjects with TMD.~   "
84259|NCT01954498|"~     The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day~     added to the diet of men seeking care for infertility will beneficially affect sperm~     parameters and fertility. The investigators will compare the walnut intervention to the~     commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.~   "
84260|NCT01954485|"~     This study aims to demonstrate the histological differences in the connective tissue~     surrounding laser-treated abutments and untreated abutments in humans.~      Working hypothesis: There are differences in the adhesion of collagen fibres around implant~     abutments with laser-produced microgrooves and standard abutments.~   "
84261|NCT01954472|"~     Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial~     (RCT) of high impact lifestyle approach of diet and exercise designed to significantly~     reduce cardiovascular events in middle-aged and older men and women at high risk of such~     events? To address this question, we propose a pilot study of 3 years in duration: 1 year~     recruitment and randomization, a full year of intervention for all recruited participants,~     and the last 6 months to assess the one year data and prepare and submit the full trial~     application, informed by the pilot study outcomes in terms of retention rate. The pilot will~     then continue on for the full 9 years of intervention and be rolled into the main study~     involving additional Canadian centers and collaborating international centers in the US,~     Britain, Europe, Australia, New Zealand, India, and South Africa.~   "
84262|NCT01954459|"~     This study will investigate the effect of wearing a small warming patch, the InsuPatch, at~     the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we~     will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous~     glucose monitor.~   "
84263|NCT01954446|"~     The primary purpose of this investigation is to validate the performance and safety of the~     Investigational Device (ID) against a validated and legally cleared device for measuring~     Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a~     period of 24 hours against a validated and legally cleared device for Ambulatory Blood~     Pressure Monitoring (ABPM).~   "
84264|NCT01954433|"~     This study compares costs and effectiveness / utility of three common orthopedic surgeries~     in shoulder and hand from the perspective of the Swiss health system and the clinic.~      The cost of health care is continuously rising, making economic considerations part of the~     decision process, in particular for the allocation of available resources. However,~     cost-effectiveness and cost-utility studies of interventions in the upper extremities are~     rare. The purpose of this study is to gain more information and to provide a basis for the~     decision process.~   "
84265|NCT01954420|"~     The purpose of the research is to test the efficacy of a patient-controlled~     cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer~     treatment, and to evaluate moderators and mediators of intervention effects. The~     intervention uses guided imagery, relaxation exercises, and nature sound recordings,~     self-administered via an MP3 player. The study will determine (1) if the intervention helps~     to control symptoms during chemotherapy, (2) if personal and clinical characteristics~     influence how well the intervention works, and (3) if the cognitive-behavioral strategies~     reduce markers of stress and inflammation found in blood and saliva.~   "
84266|NCT01954407|"~     The purpose of this study is to determine whether anti-smoking messages based on promising~     smoking-related beliefs increase anti-smoking intentions more than messages based on~     less-promising beliefs. Never smokers and former smokers will be randomly assigned to view~     different anti-smoking messages, and will answer questions measuring smoking-related~     beliefs, intentions, and message ratings online.~   "
84267|NCT01954394|"~     Primary Objective:~      To assess the long-term safety of alirocumab when added to lipid-lowering therapy in~     patients with heterozygous familial hypercholesterolemia (heFH).~      Secondary Objectives:~      To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the~     long-term immunogenicity of alirocumab.~   "
84289|NCT01954108|"~     The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and~     Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.~   "
84290|NCT01954095|"~     The purpose of this study is to analyze how the body handles and responds to progesterone~     treatment in parous and nulliparous women at risk of pre-term birth.~   "
84291|NCT01954082|"~     This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine~     the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without~     severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks~     postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.~   "
84268|NCT01954381|"~     Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general~     population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary~     disease, stroke, heart failure etc.) have already been described in this disease. Large~     epidemiological studies have also demonstrated a higher degree of severity of~     atherosclerotic vascular disease in RA patients, to such a degree that several authors have~     highlighted the fact that, in the final analysis, the prognosis of RA is rather determined~     by the severity of atherosclerotic lesions.~      By reducing RA-related systemic inflammation, it can therefore be hypothesized that 24 weeks~     of anti-TNF therapy would improve arterial endothelial function and large artery stiffness.~      The proposed study will assess the effects of adalimumab therapy on these parameters. A~     group of 26 RA patients will be recruited from a rheumatologists association of the French~     PACA region (CONCERTO association). This study will be non invasive and will comprise:~        -  in vivo study of endothelial function by measuring the post-ischaemic dilatation by 2D~          ultrasound;~        -  study of large artery stiffness by pulse wave velocity determined by aplannation~          tonometry;~        -  study of central pulse pressure;~        -  evaluation of atherosclerosis-related parameters such as intima-media thickness.~      The results obtained should provide a better understanding of the mechanisms involved in~     RA-related vascular disease and the effects of anti-TNF therapy.~      In view of the high prevalence of RA, this study could potentially interest the medical~     community as a whole and could be largely diffused.~   "
84269|NCT01954368|"~     Non-invasive and simple, intranasal (IN) route of administration seems promising for pain~     management in the Emergency Department (ED), especially when used precociously by triage~     nurse to rapidly deliver the first opioid dose to severely painful patients.~      This randomized double-blind placebo-controlled study will focus on severe traumatic pain~     experienced by adults admitted in our ED.~      We hypothesized that, in addition to traditional morphine titration, a single dose of IN~     sufentanil given at triage would significantly increase the proportion of patients relieved~     30 minutes after their ED admission.~      Time to discharge, proportion of side effects and satisfaction rates will also be recorded.~   "
84270|NCT01954355|"~     The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the~     recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of~     paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor~     activity of this combination will be assessed, in particular in ovarian cancer.~   "
84271|NCT01954342|"~     The purpose of this study is to measure energy intake and energy expenditure during and~     after pregnancy. The investigators hypothesize that obese pregnant women with weight gain~     above the IOM guidelines, 'High Gainers', will have increased energy intake but no evidence~     for changes in energy expenditure after adjustment for the weight gained when compared to~     women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the~     investigators will measure the babies born to the pregnant women enrolled in MomEE at one~     time point before 10 days of life.~   "
84272|NCT01954329|"~     MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of~     novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.~      Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of~     treatment, and thereby decrease the risk of subsequent ischemic stroke.~   "
84273|NCT01954316|"~     This is a phase 1 study to test different doses of a new investigational drug called~     CFI-400945 to see which dose is safer in people. This study will also look at the safety of~     CFI-400945 and to study its effects on patients with advanced cancers. This drug has been~     tested in animals but not yet in people.~      CFI-400945 is an oral (taken by mouth) drug that works by blocking polo-like kinase 4 (PLK4)~     from working. PLK4 is a protein that is important in regulating cell growth and division and~     cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4~     produced, it is believed to lead to uncontrolled cancer cell growth and division. Therefore,~     by blocking this protein from working, it is believed to stop tumors growing or shrink them.~   "
84274|NCT01954303|"~     Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality~     worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and~     sudden cardiac death are the most important causes of death in many countries. Cardiac~     troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for~     diagnosis of acute myocardial infarction by the Universal definition of myocardial~     infarction. Since a new generation of high-sensitivity cardiac troponin assays has become~     commercially available a few years ago, myocardial infarction can be detected earlier and~     even small AMIs, that were classified as unstable angina pectoris (UAP) with the less~     sensitive assays, are detectable now. On the other side, more patients with acute or chronic~     myocardial damage not due to AMI are identified now. Thereby, the reason for elevated~     troponin levels should be sought actively, because high troponin levels were associated with~     adverse outcome - independent of the underlying pathomechanism. The reasons for troponin~     elevations in patients with stable CAD are not clear yet. Associations with extensive~     atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were~     reported. Therefore, patients with elevated troponin levels represent a risk population and~     might profit from intensified secondary prevention. In this context, ticagrelor might be~     part of a prevention strategy as currently tested in the PEGASUS trial.~      We plan to conduct a single-centre pilot study in a cohort with clinically stable patients~     of our outpatient clinic, because data regarding prevalence, causes and prognosis of~     elevated troponin values in unselected cohorts is sparse. Therefore, all patients (n=910)~     that presented to our outpatient clinic 12 months after introduction of the high-sensitivity~     troponin T assay (june 2009) and were free of complaints or presented with UAP are being~     enrolled. All patients are characterized by demographic, laboratory and clinical~     characteristics (including medication) and all available imaging data (exercise-ecg,~     echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary~     angiography) in order to compare baseline characteristics of troponin positive and troponin~     negative patients. In addition, the Framingham- and PROCAM-Score representing established~     calculators of long-term risk prediction are calculated.~      Prognostic endpoints are defined as severe cardiovascular events and progress of the~     initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value~     and serial changes.~   "
84301|NCT01953952|"~     This randomized phase II trial studies radiation therapy and cisplatin with or without~     surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor~     cells. It is not yet known whether radiation therapy and cisplatin are more effective with~     or without surgery in treating patients with oropharyngeal cancer.~   "
84391|NCT01952782|"~     The investigators are seeking healthy volunteers and volunteers with reproductive disorders~     for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally~     occurring opioid hormone that is blocked by naloxone.~      We hypothesize that naloxone, by blocking dynorphin, will stimulate production of GnRH and~     kisspeptin, 2 other naturally occurring reproductive hormones.~   "
84275|NCT01954290|"~     Stroke remains the fourth leading cause of death in the United States (second worldwide) and~     a leading cause of long-term disability, resulting in total direct and indirect costs of~     approximately $73.7 billion annually. The failure of novel therapies in clinical trials~     demonstrates that the complex neural response to stroke must be targeted at multiple levels~     to improve patient outcomes. Despite significant improvements in stroke treatment and~     management, 1 year survival rate among stroke patients aged 65 years or more is around 25%,~     and 5- year survival rate amounts to approximately 50%. The highest chances of death are~     within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated~     intracranial pressure (ICP), and other comorbid conditions.~      Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development~     of malignant stroke and mortality. Current treatments such as osmo-therapy and~     hemicraniectomy have substantial limitations, and mortality remains high, despite these~     measures outcomes remain unsatisfactory. There is a great need for alternative medical~     approaches which are safe, predictable, and help to ameliorate post stroke edema.~   "
84276|NCT01954277|"~     The purpose of this study is to determine whether electroacupuncture is effective in the~     treatment of chronic tension-type headache, measured by Headache Impact Test, Visual~     Analogue Scale and biomarkers.~   "
84277|NCT01954264|"~     This study is designed to characterise P. falciparum transmission intensity in subjects aged~     ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate~     the use of malaria control interventions at some centres selected for the EPI-MAL-002 and~     EPI-MAL-003 studies in sub-Saharan Western Africa.~   "
84278|NCT01954251|"~     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK~     Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine~     in adults aged 50 years or older compared to administration of vaccines separately.~   "
84279|NCT01954238|"~     The purpose of this study is to evaluate the safety, tolerability and~     Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.~   "
84280|NCT01954225|"~     The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly~     defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of~     it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara'~     has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to~     tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta~     Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after~     surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is~     Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra~     has been found effective due to its action of proper drainage of pus from the fistula that~     leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano.~      Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne~     management of Fistula in ano.~   "
84281|NCT01954212|"~     Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the~     risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged~     hospital stays and dependency at discharge. Systematic review evidence indicates that~     enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia~     amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to~     treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar~     benefits might be observed in stroke care settings but current empirical evidence is weak -~     trial quality (randomisation, blinding, sample size, reporting), intervention description~     and thus feasibility of translation into clinical practice is very poor. Following an~     extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II)~     of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention~     versus usual OHC. Investigators aim to establish a robust web-based randomisation process,~     refine the proposed intervention (training, tools, equipment), recruitment, adherence,~     record linkage and sampling methodologies. Investigators also aim to establish the~     relationship between SAP and plaque and any diversity between sites.~   "
84282|NCT01954199|"~     This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic~     treatment over two weeks.~   "
84283|NCT01954186|"~     To compare the efficacy of the route and timing of oxytocin administration for Active~     management of third stage of labour (AMTSL).~   "
84284|NCT01954173|"~     This phase II trial studies how well modern, conformal radiation therapy after surgery works~     in treating patients with high-risk bladder cancer. Specialized radiation therapy that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue.~   "
84285|NCT01954160|"~     Congestive heart failure is a common disorder in which the heart cannot pump enough blood to~     meet the needs of the rest of the body. Poor sodium handling by the kidneys is a damaging~     effect of heart failure, and it leads to symptoms of congestion such as shortness of breath~     or ankle swelling. Recent studies suggest that reducing the nerve activity to a kidney could~     reduce sodium retention and blood pressure. An improvement in the way the kidneys handle~     sodium may reduce disease progression and decrease symptoms for heart failure patients.~   "
84286|NCT01954147|"~     Umbilical cord mesenchymal stem cells (SC) transplantation was a novel therapy for diabetes~     mellitus, with less side effects and more advantages. Clinical trials had verified that good~     metabolic control would be achieved when Liraglutide (GLP-1) was added to the conventional~     therapies. The investigators hypothesized that the combined therapy of umbilical cord~     mesenchymal stem cells transplantation and Liraglutide in type 2 diabetes mellitus will aid~     the differentiation of stem cells into insulin-producing cells, improve the survival of~     differentiated cells, protect the residual beta-cells and improve insulin secreting~     function, so as to achieve a favorable glucose homeostasis.~   "
84287|NCT01954134|"~     In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is~     considered as radioiodine resistant or in another words in the process of dedifferentiation.~     The aim of the present study was to search a simple blood test that could lead to early~     identification of patients with dedifferentiation. In this respect, we investigate whether~     the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients~     with high levels of thyroglobulin (tg) and negative I-131 scan.~   "
84292|NCT01954069|"~     The study seeks to test whether it is feasible and acceptable for both women and providers~     (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT)~     as a tool for follow up after MR services. The study is planned at 11service delivery points~     (primary health clinics) in Punjab province where consenting women will be asked to take a~     baseline test at the clinic the morning they present for the MR procedure. Women will be~     asked to complete a second test at home the morning of their scheduled follow up visit and~     return to the clinic for follow-up care later that day. The results of the at home test will~     be compared to the baseline to determine the outcome of the MR. This is of particular~     importance because to-date no research has documented the accuracy of the test in detecting~     MR outcomes with misoprostol only regimens.~      We hypothesize that women and providers will find the test easy and acceptable to use~     thereby improving follow up and simplifying MR service provision. In addition, the simple~     pictorial instructions will enable most women to use the test and interpret the results~     correctly on their own.~   "
84293|NCT01954056|"~     This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on~     short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in~     critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as~     defined by a need for inotrope therapy in the first 72 hours of age.~   "
84294|NCT01954043|"~     The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer)~     and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate).~     The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data~     collected from this study will be used to inform recommendations regarding use of~     concomitant medications with dabrafenib and future clinical pharmacologic evaluation of~     dabrafenib.~   "
84295|NCT01954030|"~     The primary objectives of the study are to determine the maximum tolerated dose (MTD) of~     Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among~     patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed~     bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO~     grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus~     bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2).~      This study was terminated early due to funding issues. At the time of termination, the study~     was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been~     determined for this population. Phase 2 will not proceed.~   "
84296|NCT01954017|"~     The study will be conducted in two parts. Part A will be a sequential dose escalation study~     to determine the safety and tolerability of two doses of STP206 versus control. Part B will~     evaluate safety and NEC preventive efficacy of STP206 in VLBW and ELBW neonates.~   "
84297|NCT01954004|"~     This registry is intended to evaluate the impact of genomic test results towards selecting a~     first-line therapy option for newly diagnosed localized prostate cancer patients.~   "
84298|NCT01953991|"~     Removable false teeth (called removable partial dentures (RPDs)) are commonly made for~     people with missing teeth.~      RPDs are made out of a framework and the replacement teeth/gum. The framework sits on the~     teeth and the gums and can be made out of different materials, metal or non-metal, with~     different properties. The plastic teeth and gum sit on the framework.~      A common framework material is cobalt chromium, a rigid, non-precious metal alloy. Other~     framework materials include titanium and non-metal materials such as medical grade~     polyetheretherketone (PEEK).~      A review of the literature shows that no research has been reported investigating how~     different RPD framework materials impact on a person's oral health related quality of life~     (OHQoL). The sensation that different frameworks have in the mouth can be quite varied~     between people, and it would be relevant to be able to tell patients which type of framework~     is better tolerated based on research evidence.~      We hope to conduct an un-blinded randomised crossover pilot trial investigating the~     difference in patient preference and oral health related quality of life measured by patient~     centred outcomes in a group of patients due to receive tooth supported removable partial~     dentures at the Charles Clifford Dental Hospital.~   "
84299|NCT01953978|"~     The analgesic effect of dexamethasone is not well described, but studies have shown that~     dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our~     purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has~     an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative~     pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain~     and reduce opioidconsumption and side effects compared to placebo.~   "
84300|NCT01953965|"~     The purpose of this study to look at differences in the way the heart functions in people~     with pulmonary hypertension (PH) who have near normal right ventricle (RV) function and~     people with pulmonary hypertension who have impaired RV function. The right ventricle is a~     chamber of the heart that pumps blood into the pulmonary artery (the artery that carried~     blood from the heart to the lungs). Learning more about how the heart is working in people~     with pulmonary hypertension may help researchers to understand how to better treat pulmonary~     hypertension and prevent the disease from getting worse.~      To do this, we will use two imaging techniques, MRI (Magnetic Resonance Imaging) and PET/CT~     (Positron Emission Tomography/Computed Tomography). MRI uses a strong magnet and radio waves~     to take pictures of your heart. A PET/CT scan combines a PET and CT scan into one machine. A~     CT scan uses x-0rays to take a 3-day picture of the inside of your body, while a PET scan~     measures small amounts of radiation from a dye called a tracer that we inject into your~     veins.~      You will be given two tracers as part of the PET/CT scan. A tracer is a special type of dye~     with a small amount of radioactivity in it. The tracers that are used in this study are~     called [18F]fluorodeoxyglucose (FDG) and [11C]-acetate.~      In order to take part in this study, you must also have agreed to take part in a companion~     study. In the companion study, we are trying to learn whether the drug ranolazine is safe~     and effective in people with PH.~   "
84311|NCT01953822|"~     This is an observational cohort study to assess the risk of autoimmune disease(s) within 12~     months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable~     period in the unexposed cohorts.~      This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA~     safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the~     period mid-September 2008 to 2011 to allow suitable data to be collected.~   "
84302|NCT01953939|"~     During any period of rehabilitation it is important to select meaningful tests that; measure~     what you want, are responsive to changes in the patient's condition and, easy to use in the~     clinical settings. With an amputee such tests may help make sure that rehabilitation~     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New~     prosthetic technology is continually being developed and the active amputee now demands more~     from their artificial limbs. Making sure that they get the right rehabilitation programmes~     and the most appropriate prosthesis will help them perform to their best.~      Twenty lower limb amputees who have had their artificial limb for at least one year will be~     recruited into this study. They will be asked to complete 2 walking tests and 4~     questionnaires that measure different aspects of their condition from the comfort of the~     socket to their perceived ability to undertake everyday tasks. Each of the tests give a~     score or grade which represents the level of their ability, as judged by the test, at that~     given time point. The tests will be repeated on a second occasion between seven to ten days~     after the first.~      By measuring the changes in the scores on these two occasions it is hoped that indices of~     reliability can be established for these particular tests that have been shown to be most~     widely used by Health Professional involved in the rehabilitation of amputees across the UK.~     It is also hoped that the minimal detectable change (MDC) can also be calculated for these~     tests. By understanding the MDC for a test then anyone using it will be able to know whether~     any changes in scores detected are real changes due to changes in the patient's abilities or~     just down to chance.~   "
84303|NCT01953926|"~     This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and~     safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR~     mutations or with EGFR gene amplification.~   "
84304|NCT01953913|"~     Primary objective of the trial is to evaluate the safety of afatinib in patients with~     locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal~     growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine~     kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as~     judged by investigator).~   "
84305|NCT01953900|"~     PLEASE NOTE - THIS STUDY IS CURRENTLY ONLY RECRUITING PARTICIPANTS WITH OSTEOSARCOMA.~      The purpose of this study is to find the largest safe dose of GD2-T cells (also called~     iC9-GD2-CAR-VZV-CTLs), and additionally to evaluate if a VZV vaccine can improve the~     expansion and persistence of infused T cells, to learn what the side effects are, and to see~     whether this therapy might help patients with advanced sarcomas. Because there is no~     standard treatment for recurrent/refractory sarcomas at this time or because the currently~     used treatments do not work fully in all cases, patients are being asked to volunteer to~     take part in a gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that a new gene can be put into T cells that~     will make them recognize cancer cells and kill them. Investigators now want to see if a new~     gene can be put in these cells that will let the T cells recognize and kill sarcoma cells.~     The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called~     14g2a that recognizes GD2, a protein that is found on sarcoma cells (GD2-CAR). In addition,~     it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live~     longer.~      Investigators have found that CAR-T cells can kill some of the tumor, but they don't last~     very long in the body and so the tumor eventually comes back. T cells that recognize the~     virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for~     many years especially if they are stimulated or boosted by the VZV vaccine. Investigators~     will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are~     called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.~   "
84306|NCT01953887|"~     A study to assess the amount of drug in the blood of young to middle aged, healthy, male~     subjects after they received the final formulation of EC905 compared to solifenacin~     (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).~      Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS®~     in 3 separate periods.~   "
84307|NCT01953874|"~     The aim of the study is to compare the effects of MV targeted ASV in addition to optimized~     medical therapy versus optimized medical therapy alone at 6 months in patients with acute~     decompensated HF. The study will also assess changes in functional parameters, biomarkers,~     quality of life (QOL), and sleep.~   "
84308|NCT01953861|"~     To evaluate the effect of food (low and high fat breakfast vs. fasting) on the~     pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and~     tamsulosin administered as combination tablet EC905. Also to evaluate the safety and~     tolerability of single doses of EC905 in young, healthy male subjects, when administered~     under fed (low and high fat) or fasting conditions.~   "
84309|NCT01953848|"~     Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints~     related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the~     treatment of patients suffering from problems related to overactive bladder, such as needing~     to go to the toilet frequently and often having a sudden urgent need to go to the toilet.~     Certain patients with an enlarged prostate have complaints that may benefit from a~     combination of tamsulosin and solifenacin. EC905 is a single tablet containing both~     tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and~     solifenacin are taken up from the intestine, distributed through the body and eventually~     eliminated from the body when taken as a single EC905 tablet.~   "
84310|NCT01953835|"~     This study is a Phase I, two-part, open-label study designed to evaluate the effect of~     repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in~     healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet~     formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single~     sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will~     be enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two~     occasions, once alone and once following administration of repeated doses of GSK2586184.~     Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3~     subjects to each treatment sequence). Each subject will receive a single dose of the~     standard formulation of GSK2586184 with food and two doses of a new formulation of~     GSK2586184, once with food and once in a fasted state, according to their treatment~     sequence, with a 3-day wash out between doses. The primary aim of the study is to~     investigate the effects of GSK2586184 on the pharmacokinetics of the 2 statins and to assess~     the impact of dosing with and without food on a new formulation of GSK2586184 tablet.~   "
84419|NCT01952418|"~     The goal of this study is to compare the adenoma detection rate achieved while using either~     a 24 video monitor or a 32 video monitor.~   "
84312|NCT01953809|"~     This study is being conducted to confirm that GSK1322322 has no negative impact on hormone~     levels and contraceptive efficacy when co-administered with a frequently prescribed oral~     contraceptive thereby to facilitate the use of GSK1322322 in women of child-bearing~     potential receiving oral contraceptive (OC) pre-infection. This study is designed to~     investigate steady-state plasma ethinyl estradiol (EE) and norethindrone (NE)~     pharmacokinetic (PK) following administration of Ortho-Novum (EE/NE) 1 tablet every 24 hours~     (q24h) fed with and without GSK1322322 1500 milligram (mg) q12h fed. Each subject will~     participate in the study for approximately 12 weeks: a 30 day screening period, 4-week~     run-in period, three 7 day treatment periods, and a 3-5 day follow-up period. The study is~     planned to enroll approximately 24 subjects (18 active/6 placebo).~   "
84313|NCT01953796|"~     The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol~     to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional~     protocol.~      Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder~     teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the~     inclusion criteria, they were divided into two groups; 65 patients for the stair step~     protocol and 75 patients for the traditional protocol.~   "
84314|NCT01953783|"~     This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients~     with advanced solid tumors or lymphoma.~   "
84315|NCT01953770|"~     QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY~        1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of~          remission, improvement of days 8 and 15 responses leading to an earlier reconstitution~          of bone marrow and immunocompetence, decrease of severe infections and early mortality~          rate?~        2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines~          in standard risk group patients and to reduce treatment myelotoxicity?~        3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18~          doses of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve~          treatment outcome?~        4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st~          consolidation in intermediate risk patients will result in decrease of central nervous~          system relapse incidence and improvement of event-free and overall survival? Whether~          the increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation~          phase (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied~          with enhanced toxicity?~        5. Is it possible to completely avoid the cranial irradiation in intermediate risk~          patients? In some subgroup of intermediate risk patients? Is it enough to control~          neuroleukemia in these patients to introduce additional TIT in the consolidation phase~          of treatment? How will change the possible late effects in these patients according to~          the third arm of randomization?~        6. Will the new risk group stratification to improve overall and event-free survival?~   "
84316|NCT01953757|"~     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a~     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation~     and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet~     changes. The principal measure is pain as measured by the following assessment tools:~     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy~     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale,~     McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.~      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for~     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.~   "
84317|NCT01953744|"~     The purpose of this study is to evaluate the therapeutic response to fluconazole in patients~     with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.~   "
84318|NCT01953731|"~     This study will compare the plasma pharmacokinetics of a single 125mg oral dose of~     palbociclib in the presence and absence of rifampin-mediated enzyme induction in a~     fixed-sequence two-period study.~   "
84319|NCT01953718|"~     The purpose of this study is to assess the impact of different parameters (voltage, pulse~     width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor~     symptoms in patients with Parkinson's disease (PD).~   "
84320|NCT01953705|"~     Brain scans can help identify changes that appear to increase risk for cognitive decline and~     dementia. Some of these brain changes are thought to reflect actual damage to the small~     blood vessels that support normal brain function. This clinical trial will determine whether~     an omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting~     the small blood vessels in the brain over 3 years in older adults at high risk for cognitive~     decline and dementia of Alzheimer's type.~   "
84321|NCT01953692|"~     The purpose of this trial is to evaluate the safety, tolerability, and efficacy of~     pembrolizumab (MK-3475, KEYTRUDA®) in hematologic malignancies. The primary study hypotheses~     are that treatment with pembrolizumab will result in a clinically meaningful improvement in~     Objective Response Rate (ORR) or Complete Remission Rate (CRR).~   "
84322|NCT01953679|"~     To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate~     5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.~   "
84333|NCT01953536|"~     The purpose of this study is to assess the efficacy and safety of vintafolide alone compared~     to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive~     folate receptor (FR) triple negative breast cancer (TNBC).~      The primary hypothesis of this study is the vintafolide alone and/or vintafolide +~     paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC~     compared to paclitaxel alone.~   "
84334|NCT01953523|"~     To evaluate for any adverse effects that may be related to the administration and reception~     of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study~     monitors the results of subjective and objective findings as it applies to the non-blinded~     deployment of autologous SVF for various inflammatory and/or degenerative conditions~     including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF~     deployments include intra-venous, intra-articular, and soft tissue injections.~   "
84459|NCT01951898|"~     Montelukast is one of anti-inflammatory agents and a good controller for the patients with~     asthma. The hypothesis of the study is that the Montelukast will have airway~     anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.~   "
84323|NCT01953666|"~     Computers now play an important role in the lives of most individuals.Access to computers is~     crucial for people with disabilities and may improve their quality of life. The use of~     computers can facilitate mainstreaming at school, for example, and the Internet may provide~     a valuable means of communication. However, the use of computers requires a certain degree~     of motor ability. People with motor disabilities frequently experience difficulties using a~     standard keyboard and standard pointing input systems such as a mouse. Many solutions exist~     to facilitate computer access, depending on the person's specific impairments and the~     purpose for which the computer is used. The most common solution relies on the use of a~     virtual keyboard which is directly displayed on the computer screen. The selection of the~     desired key on the virtual keyboard can be handled by a large variety of input devices, from~     a microgravity mouse to single switch devices supplemented by a process of dynamic scanning~     of the keyboard.Although such assistive devices render computers accessible to people with~     disabilities, the actual inputting of text can be very slow. A method to increase text input~     speed is to display words which are predicted from the letters previously typed. Word~     prediction reduces the number of necessary key strokes by avoiding having to type the whole~     word. The effect on text input speed is, however uncertain and results in the literature are~     inconclusive. Indeed, word prediction software provide a enhancement of cognitive load which~     decrease text input speed.The reduction of cognitive load could therefore be based in part~     on the optimization settings of the software and / or achievement of a rehabilitation~     program.Our hypothesis are for people with spinal cord injury : i) optimization settings~     word prediction software and ii) a rehabilitation program could improve the text input~     speed.The investigators propose to study the influence of settings word prediction software~     on text input speed and the influence of a rehabilitation program provided by a therapist,~     focused on word prediction software to help integrate them. The aim is to increase the~     performance of people with spinal cord injury and their satisfaction.~      The first phase of this research is to select the word prediction software and configuration~     that provides the best user support.The second phase corresponds to the objective of~     evaluating the efficiency of a rehabilitation program .~   "
84324|NCT01953653|"~     This protocol explores the feasibility and acceptability of using two daily diary methods to~     analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency~     Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the~     potential of diaries for use in feedback-based interventions.~   "
84325|NCT01953640|"~     This research trial studies gene expression in patients with prostate cancer that has spread~     to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase~     (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory~     from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes~     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may~     also help doctors understand how well patients respond to treatment.~   "
84326|NCT01953627|"~     Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is~     limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.~      Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic~     procedures in gynecology.~      Material and methods : Observational study. Inclusion criteria were : patient requiring~     laparoscopic procedure in gynecology who give informed consent. The investigators evaluate~     procedures routinely performed by laparoscopy in gynecology.~      Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax®~     system.~   "
84327|NCT01953614|"~     Despite the abundance of theories concerning the effects of chiropractic adjustments on~     brain function, this remains an understudies area for the profession.~      Quantitative Electroencephalography (qEEG)is a technique that allows for an in-depth~     analysis of brain function. A normative database will be used to compare before, during and~     after effects of chiropractic adjustments on brain function. This will include usage of Low~     Resolution Electromagnetic Tomography (LORETA).~      This study seeks to objectively document effects of chiropractic adjustments on brain~     function.~   "
84328|NCT01953601|"~     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is~     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo~     administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due~     to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to~     receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis~     for Part 1 is that at least one verubecestat dose is superior to placebo with respect to the~     change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at~     104 weeks. Participants who complete Part I of the study may choose to participate in Part~     II, which is a long term double-blind extension to assess efficacy and safety of~     verubecestat administered for up to an additional 260 weeks. In Part II, all participants~     will receive either 12 mg or 40 mg verubecestat, once daily.~   "
84329|NCT01953588|"~     The study is being conducted to determine whether neoadjuvant endocrine therapy with~     fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole~     when given before surgery to shrink the cancer and stop it from growing. Anastrozole~     inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food~     and Drug Administration (FDA) of the United States for use after surgery for postmenopausal~     women with estrogen receptor positive breast cancer. It is also considered a standard of~     care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant~     inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It~     is not approved by the FDA for use in women with early stage breast cancer before or after~     surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor~     positive breast cancer that has spread to other parts of the body.~   "
84330|NCT01953575|"~     Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal~     impedance?~      And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities~     in mucosal impedance?~   "
84331|NCT01953562|"~     The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the~     NICU who are potential candidates for extubation from mechanical ventilatory support. For~     all parents who consent, the routine SBT will be performed on all infants. In addition to~     the routine SBT the following will occur:~        1. work of breathing indices: obtained non-invasively through respiratory inductive~          plethysmography (RIP).~        2. Performing the SBT in the prone position, in addition to the routine position (supine).~   "
84332|NCT01953549|"~     The aim of this study is to investigate whether a 4-week physical fitness training (target~     intervention) in stroke patients (subacute stage) increase the walking speed and activities~     of daily living compared with a control intervention (relaxation exercises). The target or~     control intervention is performed in addition to standard rehabilitation treatment.~   "
84349|NCT01953328|"~     The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous~     evolocumab administered every 2 weeks and once a month, compared with placebo, on percent~     change from baseline in LDL-C when used in combination with statin therapy in adults with~     high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.~   "
84335|NCT01953510|"~     Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases.~     These bacteria normally live in the nose of humans and are spread from person to person by~     touching or sneezing. There are vaccines available to protect against infection with these~     bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in~     young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has~     been a big impact on the amount of disease caused by these bacteria. However, many~     countries, especially developing countries, are yet to introduce PCV as part of their~     routine immunizations. Currently a total of four doses of PCV is recommended, and the main~     barrier to vaccine introduction is cost. This study aims to identify a vaccination schedule~     to make PCV more effective and affordable for Vietnam and other developing countries.~      This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2)~     to compare different PCV vaccines.~        1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series~          and two booster options will be compared. Comparisons will be made firstly in terms of~          measures of immunity to the vaccine, and secondly in terms of the effect of vaccination~          on the carriage of bacteria in the nose.~        2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most~          likely to be considered for global use. Again, comparisons will be made in terms of~          measures of immunity and effect on carriage in the nose.~      Infants aged two months will be randomly assigned to one of six study groups and will~     provide up to four blood samples for analysis of the measures of immunity and five nose~     swabs for analysis of carriage of bacteria. Infants will be followed up 8-9 times until the~     age of 24 months. An additional control group will be recruited at 18 months of age and also~     followed up until 24 months of age.~      The results of this study will be used to facilitate decision making, at global and national~     levels, regarding introduction of PCV.~   "
84336|NCT01953497|"~     To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the~     food effect on PK.~   "
84337|NCT01953484|"~     In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide~     (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to~     hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency,~     extracorporeal carbon dioxide removal may be used to control spontaneous ventilation,~     limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little~     is known about how spontaneous ventilation changes in response to changes in extracorporeal~     carbon dioxide removal during acute respiratory insufficiency, especially in humans.~      Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated~     with extracorporeal gas exchange support because of acute respiratory insufficiency, in~     response to changes in extracorporeal carbon dioxide removal.~   "
84338|NCT01953471|"~     Prospective multi-center study carried out in France involving patients with allergic~     rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is~     required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.~   "
84339|NCT01953458|"~     -  The cohort will integrate clinical, genetic, pharmacogenomics, environmental,~          biomarkers and behavioral data in a large number of patients and will be a leading~          equipment for crossdisciplinary and translational research on hepatitis.~        -  The cohort will be the main support for estimating the relative effects of treatments~          and for further cost-effectiveness studies on the management and treatment options in~          chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.~   "
84340|NCT01953445|"~     This phase II trial studies the effects of paclitaxel combined with phosphoinositide~     3-kinase (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is~     described as estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative and~     endocrine therapy resistant. Drugs such as paclitaxel stop the growth of tumors by blocking~     cancer cell division. PI3K inhibitor BKM120 inhibits some of the enzymes needed for cell~     growth and may improve the response of endocrine resistant tumors to treatment. Giving~     paclitaxel and PI3K inhibitor BKM120 before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
84341|NCT01953432|"~     Cocaine use disorders affect approximately 1.5 million Americans annually. Currently, there~     are no US Food and Drug Administration approved medications for treatment of cocaine~     dependence; however, both animal and human studies suggest that medications affecting the~     noradrenergic system can reduce cocaine craving and use. The investigators will study the~     effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety~     symptoms among cocaine-dependent individuals. In addition, the investigators will identify~     genetic subpopulations of participants who preferentially respond to the medication.~   "
84342|NCT01953419|"~     This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with~     pretreated metastatic gastric cancer.~   "
84343|NCT01953406|"~     The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the~     patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease~     with sorafenib.~   "
84344|NCT01953393|"~     Type 2 diabetes is characterized by increased insulin resistance and impaired insulin~     secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated~     by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been~     shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear~     whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose~     stimulated insulin secretion (GSIS) in vivo.~      We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human~     TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during~     a 4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).~   "
84345|NCT01953380|"~     The purpose of this study is to determine whether extended information given to patients~     with contact allergy improves knowledge, treatment efficacy and daily functioning.~   "
84346|NCT01953367|"~     This study will investigate the bioequivalence and compare the safety profiles following~     inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.~      Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra~     nebulizer solution compared to TOBI nebulizer solution.~   "
84347|NCT01953354|"~     The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova~     (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response~     and if there are related changes in participants' UC.~   "
84348|NCT01953341|"~     The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated~     in healthy subjects and subjects with migraines. As part of the secondary objectives, this~     study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize~     the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure~     after single oral doses in healthy subjects and subjects with migraines~   "
84350|NCT01953315|"~     This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the~     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).~   "
84358|NCT01953211|"~     The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian~     axis during the hormone-free interval in combined oral contraceptive (COC) hormone users~     varies depending on the dose of ethinyl estradiol in the formulation. This variation in~     activation may be associated with different side effects during the hormone free interval.~     Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates~     continuous contraceptive efficacy during the 7-day hormone free interval of all formulations~     studied.~   "
84359|NCT01953198|"~     The aim of the project High Altitude Medical Research Expedition Himlung 2013~     (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary~     adaptation and the reactions of the human immune system during an ascent to extreme~     altitudes of over 7000 m. A total of 44 healthy and trained volunteers will be included in~     the study after written informed consent has been obtained.Baseline sea level clinical~     examination will be performed in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before~     departure. High altitude research facilities will be available at the altitudes of 5000m,~     6100m and 6900m. Post-expedition examination will be performed within 2 to 6 weeks after the~     end of the expedition in Bern. In the context of 3 sub-projects specific measurements and~     examinations are performed.~      These include: cMRI before and after the climb and neurovascular doppler examination during~     the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress~     tests for assessment of cardiovascular performance.~   "
84360|NCT01953185|"~     Question: Does manual diaphragm release change kinematics and respiratory function of~     elderly subjects? Design: Randomized controlled trial with concealed allocation and~     double-blinding.~      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control~     Group (CG) and 08 in the Intervention Group (IG).~      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten~     deep breaths, with a one minute interval between them. The CG underwent a sham protocol~     (light touch), with same sets and time of interval.~      Outcome measures: The groups were evaluated using spirometry, manovacuometry and~     optoelectronic plethysmography (OEP), in that order, before and immediately after the~     intervention.~   "
84361|NCT01953172|"~     The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health~     status and quality of life measures, cognitive functioning, oxidative stress, inflammation~     markers and other symptoms effects on skin, sleep and vision in the elderly.~   "
84362|NCT01953159|"~     The purpose of this study is to collect clinical data, blood samples, and self reported~     symptoms from patients that experience unusually severe neuropathy after treatment with~     paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood~     samples will be used to create induced pluripotent stem (iPS) cells and eventually~     artificial nerve cells to be used to study neuropathy in the lab.~   "
84363|NCT01953146|"~     Polycystic ovary syndrome is one of the most common causes of female infertility. The cause~     of infertility in PCOS is unknown. Factors other than anovulation, including inherited or~     induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo~     development is a sensitive method of detecting reduced embryo viability. Yet, there are no~     data regarding the embryo development in PCOS assessed by time-lapse analysis.~   "
84364|NCT01953133|"~     The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49~     year old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating~     continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa~     found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual~     partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention~     interventions that target couples in South Africa. This study is a randomized controlled~     trial of a behavioral intervention to increase HIV testing among couples living in~     Vulindlela, South Africa.~      The proposed intervention consists of six sessions (one mixed gender group, one single~     gender group, and four couples' counseling sessions). Using a randomized controlled trial~     (RCT) design with 350 heterosexual couples, we will test the hypothesis that compared with a~     one-time mixed-gender group session, the proposed intervention will improve communication,~     intimacy and trust necessary for mutual decision-making about behaviours related to sexual~     risk behaviour and testing for HIV. Improving couples' ability and motivation to participate~     in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in~     sexual risk behaviour. Both of these outcomes are necessary and effective strategies to~     reduce the risk of HIV transmission within primary partnerships.~      This intervention is informed by several qualitative studies conducted in Vulindlela and~     Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These~     preliminary studies provided insight into the challenges couples face in participating in~     CHCT, as well as the skills they need in order to address these barriers. Our experience~     conducting both qualitative and quantitative studies with comparable populations (i.e. South~     African couples) has also informed the recruitment and retention methods in this~     intervention. The proposed study takes advantage of the infrastructure and collaborative~     relationships that the PI has developed that have enabled her to implement and conduct~     research within these communities.~      The specific aims of the project are to test the efficacy of a theory-based and culturally~     appropriate couples-based intervention on the following outcomes:~        1. Rates of testing for HIV,~        2. Sexual risk behaviour for HIV (with primary and any concurrent partners).~      In addition we will evaluate the extent to which hypothesized mediating factors (e.g.,~     relationship dynamics) explain the major outcomes and the extent to which the intervention~     affects these factors.~      Ultimately, our goal is to facilitate the outcome that members of partnerships learn their~     own and their partner's HIV status. This is a crucial step for effective behavioural risk~     reduction, yet it is a relatively uncommon occurrence for partners in Vulindlela, South~     Africa. Specifically, mutual disclosure of HIV status accomplishes two important goals.~      First, this knowledge can facilitate risk-reduction behaviour within partnerships via~     effecting positive changes (e.g., condom use) in sexual behaviour with primary and any~     concurrent partners. Second, knowledge of HIV status can increase access to treatment and~     care for HIV-positive individuals, as well as reinforce behavioural choices (e.g., limiting~     concurrent partners) to stay HIV-negative. As couples are particularly vulnerable for HIV~     infection in this context, increasing testing for HIV and reducing likelihood of behavioural~     transmission of HIV within partnerships would be a high-impact outcome with the potential to~     significantly reduce the impact of HIV in an area already severely affected by the pandemic.~   "
84365|NCT01953120|"~     This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the~     prevention of acute rejection and preservation of kidney function in transplant patients.~     Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and~     is being marketed as Nulojix. The pharmaceutical company sponsoring this study is~     Bristol-Myers Squibb.~      Belatacept is a prescription medicine used in adults to prevent transplant rejection in~     people who have received a kidney transplant. Transplant rejection happens when the body's~     immune system senses that the new transplanted kidney is different or foreign, and attacks~     it. Belatacept is used with corticosteroids and certain other medicines to help prevent~     rejection of your new kidney.~      The purpose of the research is to understand whether the new drug, belatacept, is better~     than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used~     in the treatment against kidney rejection in transplant patients.~   "
84366|NCT01953107|"~     The prevalence of anemia in gynecologic oncology new patients has been seen in previous~     studies to be as high as 35-59%. this population includes women with several types of~     gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due~     to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at~     the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly~     diagnosed gynecologic malignancies.~      Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates~     does treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean~     change in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.~   "
84367|NCT01953094|"~     The purpose of this study is to determine the possibility and compliance of performing anal~     Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital~     tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this~     population using a high-resolution anoscopy (HRA). In addition, it is being done to~     potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women~     with high-grade lower genital tract dysplasia or cervical cancer.~   "
84368|NCT01953081|"~     This study is being conducted to evaluate the safety, tolerability and early efficacy of IV~     TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are~     admitted to the intensive care require mechanical ventilation, and are intolerant to enteral~     feeding.~   "
84378|NCT01952951|"~     The current standard treatment of locally advanced rectal cancer (clinical stage II or III)~     is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can~     be suboptimal for patients with high risk features (more deeply-seated tumor or many~     regional lymph nodes involved)that are associated with recurrence. This study test a~     hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of~     preoperative treatment.~   "
84379|NCT01952938|"~     Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery.~     Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical~     follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters~   "
84369|NCT01953068|"~     Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of~     post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive~     functions are located, are highly susceptible to trauma caused by possible blood~     malperfusion to these areas of the brain during surgery. Conventional and established~     neuropsychological test methods are poor in distinguishing these kinds of trauma, as they~     are isolated, structured tests that do not require multitasking and processing of multiple~     stimuli at the same time.~      The phase 1 goal of this study is to employ an experimental Executive reaction time (RT)~     test to see if this method could improve objective detection of subtle brain dysfunction~     assumed to underlie persistent cognitive, somatic, and affective complaints reported by~     patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the~     study will concentrate on patients undergoing transcatheter aortic valve implantation~     (TAVI).~   "
84370|NCT01953055|"~     Current treatment options for high risk localized prostate cancer include radical~     prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation~     therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3~     Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater~     sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically~     allows for biological dose escalation with fewer visits and no additional toxicity.~     Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological~     control of SBRT for high risk prostate cancer incorporating ENI.~   "
84371|NCT01953042|"~     This study will examine the effect of offering information sessions to a randomized group of~     patients with OCD spectrum disorders. Psychoeducation is a component of first line~     treatment; though intended to be informative in nature, these psychoeducation services can~     have a positive effect on quality of life, sense of self-efficacy, functioning and a~     person's readiness to engage in long term treatment. However, no studies have dismantled and~     tested the independent effect of psychoeducation from standard treatment such as Cognitive~     Behavioural Therapy. This study aims to directly test the potential effect of one aspect of~     CBT that if found to be helpful, can become a distinct early intervention component of care~     so that as people await services, they can profit from the early benefits associated with~     attending these information sessions. This study therefore sets out to examine the potential~     early benefits of providing education about the illness on symptom functioning, quality of~     life and readiness to engage in more formal treatment. We will offer 4 structured~     information sessions to individuals allocated to a wait list for services related to the~     treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding~     a didactic structured psychoeducation program to our services. The study will be a~     randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4~     educational sessions covering information on diagnosis, treatment, available resources and~     self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional~     information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment~     phase) repeated measures factorial design. It is hypothesized that subjects participating in~     the psychoeducation group compared to the wait list control group will see greater~     reductions in self-reported measures of symptom severity and improvement in other measures~     of quality of life, level of functioning, self-efficacy and readiness to engage in~     treatment. If this study can demonstrate that the addition of a short structured informative~     intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD~     spectrum disorders, then it provides another route by which patients can improve this~     condition specifically while waiting for consultation and the opportunity to receive a more~     structured, evidence-based treatment.~   "
84372|NCT01953029|"~     The objective of our work to determine the mechanisms of myocardial infarction in women~     without obstructive coronary artery disease.~   "
84373|NCT01953016|"~     Background:~      - People with primary immune deficiency diseases (PIDD) have weak immune systems. This makes~     it hard for their bodies to fight infection. The Immune Deficiency Foundation has a network~     to collect data about people with PIDD. It is called the United States Immunodeficiency~     Network. It will help doctors and scientists better understand these disorders. The goal is~     to get medical data for everyone with these disorders in the U.S. and Canada. Data will be~     stored in a registry. Researchers can use it to study if these disorders are increasing.~     They can also learn how the disorders are diagnosed and treated.~      Objectives:~      - To collect data on people with primary immune deficiency disorders.~      Eligibility:~      - People who have a PIDD, or are a carrier for one.~      Design:~        -  Data can be added with no record of personal identity.~        -  Data can be added with identity kept separate. This data will be linked to the registry~          by a code number.~        -  Data for the registry includes:~        -  Family history~        -  Disease treatment~        -  Disease characteristics~        -  Medical history~        -  Laboratory data~   "
84374|NCT01953003|"~     Options for the treatment of patients who have progressed after an anthracycline and a~     taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of~     patients do not respond to this treatment and those who respond eventually develop clinical~     resistance.~      The antitumour activity of vinflunine has been demonstrated in patients with breast cancer~     after exposure to anthracycline and to taxane.~      Vinflunine plus capecitabine has been shown to be a feasible combination for patients~     previously treated with an anthracycline and a taxane. Each drug in combination can be~     administered at efficacious doses.~      This population has few therapeutic options with established clinical benefit. The~     development of a new regimen and potential new standard of care for this group is important.~        -  Primary objective:~           • to compare in patients with advanced breast cancer pretreated with anthracycline and~          taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine~          alone, in terms of progression-free survival.~        -  Secondary objectives:~             -  to evaluate the response rate, the time to response and the duration of response~               in both arms~             -  to compare the disease control rate between arms~             -  to evaluate the duration of disease control in both arms~             -  to evaluate the overall survival in both arms~             -  to evaluate safety~      Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of~     334 patients with advanced breast cancer who have previously been treated with an~     anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus~     capecitabine (Arm A) or capecitabine alone (Arm B).~   "
84375|NCT01952990|"~     The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray~     containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy~     pediatric subjects.~   "
84376|NCT01952977|"~     The purpose of this study is to test the effects of medium chain triglyceride consumption,~     relative to long chain triglycerides, on hormones involved in appetite regulation and food~     intake in overweight men. We expect medium chain triglycerides to reduce appetite and food~     intake and to do so by increasing levels of hormones known to be involved in satiety and~     reduce levels of those involved in appetite.~   "
84377|NCT01952964|"~     The present study aims to compare the differences in exit site infection between patients~     receiving spray dressing and conventional care. The outcome measures including catheter exit~     site infection rate, skin allergy, catheter damage and patient satisfaction~   "
84381|NCT01952912|"~     The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might~     yield functional results comparable to OP but with lower perioperative morbidity, and have~     equivalent long-term efficacy with OP for large prostates. The first objective was to~     demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year~     postoperatively.~      To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP~     with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up~     period of 6 years.~   "
84382|NCT01952899|"~     Objective: Delirium is an important and frequently occurring complication in intensive care~     patients. However, screening and treatment of delirium is not in accordance with current~     national and international guidelines. The first objective of this prospective study is to~     describe the barriers and facilitators for guideline adherence. Second, investigators will~     develop a tailored implementation strategy. Finally, investigators will describe the effects~     of the tailored implementation on the adherence of the guideline in a pilot study. Design:~     Current practices, attitudes and deviations from a national (Dutch) delirium guideline will~     be assessed in a prospective before-measurement. Barriers and facilitators will be~     identified with surveys and focus group interviews. Adherence to the guideline will be~     studied in a before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the~     effect of a multifaceted implementation strategy-guided implementation will be assessed with~     regard to important clinical outcomes, such as mortality and delirium incidence. Population:~     Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients.~     Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is~     implemented in this study. Implementation strategies: Barriers and facilitators will be~     determined in focus group interviews (n=7) with health care professionals resulting in a~     tailored guideline implementation strategy. In the development of the strategies specific~     attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current~     practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation~     strategy; 4. Percentage of adherence to the guideline (early screening, prevention and~     treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality,~     delirium incidence). Data analysis / power: The main effects, guideline adherence, will be~     evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided~     alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of~     85%. Economic evaluation: The economic analysis will be performed from a health care~     perspective. Investigator will calculate and compare the direct medical costs of usual care~     (before) and care after implementation of the guideline. Additionally, the cost of the~     tailored guideline implementation process will be calculated. The economic analysis will be~     a cost-minimalization analysis.~   "
84383|NCT01952886|"~     The purpose of this study is to assess patient satisfaction, the efficacy and compliance of~     granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in~     malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant~     temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing~     compliance.~      All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY~     of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized~     to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will~     received the other medication. The granisetron transdermal delivery system (supplied as a 52~     cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours~     before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is~     taken once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out~     questionnaires regarding the effectiveness of the medication and their satisfaction, and~     which anti-emetic they prefer.~      Safety will be assessed throughout the six weeks of radiation by the clinical research nurse~     using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who~     receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will~     be included in analyses of treatment preference. However, all other efficacy and safety~     analyses will include all subjects who received ondansetron or GTDS.~   "
84384|NCT01952873|"~     It is universally accepted that high-pressure balloon inflation is required to most~     effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor~     are there any guidelines regarding the method of balloon inflation, particularly the~     duration of inflation. Underexpansion and strut malapposition after stent deployment are~     among the most powerful predictors for adverse vessel outcomes. High-pressure inflation for~     stent deployment is effective to optimally expand the stent, but unlike in vitro testing in~     air, there are poorly distensible plaque elements that may not instantaneously yield to the~     balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most~     clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The~     investigators have noted that when balloon pressure is maintained at a certain pressure~     level it tends to decrease over time, and may require 60-180 or more seconds to maintain~     pressure stability. This finding implies that plaque elements are yielding slowly over time~     to the increased pressure, thus increasing expansion, and suggests that a prolonged~     inflation until balloon pressure stabilizes is more effective than a rapid~     inflation/deflation sequence to fully expand and appose the stent to the vessel wall. At~     present there is no consensus on stent deployment strategy. It is our hypothesis that~     prolonged inflation is superior to the more commonly used strategy of rapid~     inflation/deflation.~      Optimal coherence tomography (OCT), a novel technology that measures near-infrared light~     reflections and translates them into a 2D image, has an axial resolution nearly 10-times~     that of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent~     apposition and stent expansion using this modality.~      The current randomized trial tests the hypothesis that prolonged balloon inflation until a~     stable balloon pressure is maintained is more effective than a rapid inflation/deflation~     sequence when performed to the same balloon inflation pressure.~   "
84385|NCT01952860|"~     The goal of this research study is to learn the opinion of patients and their caregiving~     about a couple-based Hatha Yoga program during treatment for cancer. Researchers also want~     to learn the effect of this program on lung function, distress, and quality of life.~   "
84386|NCT01952847|"~     The goal of this clinical research study is to learn if glutamine can help control and~     prevent sores, blisters, or inflammation in your mouth or esophagus due to your current~     treatment.~      In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks~     like the drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~   "
84387|NCT01952834|"~     The study is being performed to determine whether probiotics (GoodBelly) improves blood~     vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its~     host) the lives in the intestine. Patients who have coronary artery disease will be enrolled~     in this study. The research results will be used to determine if the type of bacteria~     present in the intestines play a role in the pathogenesis of cardiovascular disease.~     Patients with coronary artery disease will be enrolled for up to 12 weeks. Patients will~     take the probiotic for 6 weeks. Following the 6 week period there is a washout period of 4~     weeks, and an optional antibiotic study called vancomycin. Patients will take the vancomycin~     for 10 days. Blood vessel function will be measured by ultrasound before and after the~     probiotic supplement and vancomycin antibiotic. Blood will also be taken before and after to~     evaluate for markers of inflammation.~   "
84388|NCT01952821|"~     The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30~     Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory~     as reliable and valid outcome measurements for patients with head and neck cancer.~   "
84389|NCT01952808|"~     This project will broadly explore the efficacy of community participation in the design and~     implementation of an intervention to improve physical activity and nutrition among immigrant~     and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota~   "
84390|NCT01952795|"~     The purpose of this study is to determine the impact of diet and physical exercise program~     on pregnancy rate and live birth in obese women who undergo an IVF cycle.~   "
84392|NCT01952769|"~     Diffuse pontine gliomas are incurable with currently used treatments. based on data stating~     that progressive tumors inhibit immune system, would try to enhance immune system activity~     and tumor cell killing. anti PD1 prevents one of the important mechanisms allowing the tumor~     to supress the immune system thus we hope it will allow for prolonged control of the tumors~   "
84393|NCT01952756|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are~          inversely associated with coronary risk factors and atherosclerotic diseases such as~          PAOD.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of~          action in patients with mild-to-moderate PAOD.~   "
84394|NCT01952743|"~     We propose a pilot study to assess safety and benefit of renal artery ablation at the time~     of planned atrial fibrillation ablation.~   "
84395|NCT01952730|"~     This study is a Pilot clinical trial. Pilot clinical trials test the safety of an~     investigational combination of drugs. Pilot studies provide information on what effects,~     both good and bad, the Investigational agent might have on your disease. Investigational~     means that the intervention is still being studied and that research doctors are trying to~     find out more about it. It also means that the FDA has not approved the treatment for your~     type of cancer.~      The main purposes of this study are to determine:~        -  The amount of vaccine that can be made for your colorectal tumor cells~        -  If the vaccine can be given safely~        -  What the effects of the vaccine are, both good and bad~        -  How the vaccine affects your immune system~        -  Whether this vaccine might have any effect on the return of your cancer in the liver~          after surgical removal~      This study is being done because there are currently no treatments which have demonstrated~     to cure diseae which has progressed, or moved beyond the site of the primary site of disease~     (colon or rectum). These vaccinations will be given after you have completed the standard of~     care treatment as determined by your doctor.~      Laboratory research has made vaccines from cancer cells by inserting genetic material from a~     protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer~     cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The~     vaccine made form these cells has a greater anti-tumor effect than cancer cells without~     GM-CSF. The purpose of this research study is to determine the safety of an investigational~     vaccine that will be made using your own colorectal cancer cells in the manner described~     above.~      This vaccine has been used in several other research studies for treatment for other cancers~     (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies~     suggests that this vaccine may help to reduce the risk of your colorectal cancer returning~     after you have your colorectal cancer surgery.~      Due to these results in melanoma and several other tumors we are encouraged to use this~     vaccine approach in patients with liver metastases from colorectal cancer, after the cancer~     in the liver has been removed by surgery.~   "
84396|NCT01952717|"~     A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D~     Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the~     Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).~   "
84397|NCT01952704|"~     Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that~     aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's~     primary memory center. Only two studies have been conducted in humans, one in healthy~     elders, and the other in a schizophrenia population. So far, there has never been an aerobic~     exercise trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as~     outcomes of interest. The proposed project is a randomized controlled trial of aerobic~     exercise in persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic~     exercise (stationary cycling), versus a control condition of non-aerobic exercise~     (stretching), in memory-impaired TBI patients to a) increase hippocampal volume and b)~     improve memory. Importantly, we also expect benefits of aerobic exercise on the level of~     brain function. Specifically, we will look at 'functional connectivity,' which refers to how~     efficiently remote regions of the brain 'talk' to each other. TBI is an ideal population to~     benefit from aerobic exercise, given the young age at which many individuals sustain TBI,~     which allows for benefits of aerobic exercise to be maximally realized in a population with~     sufficient neurofunctional reserve. The expected benefits of aerobic exercise (increased~     hippocampal volume, improved memory) from this intervention stand to have a meaningful~     impact on people with TBI, including improved health, productivity, independence, and~     quality of life. And, unlike current treatments for memory impairment (e.g., pharmacological~     agents, cognitive rehabilitation), aerobic exercise is a cost-effective, all natural,~     readily-available treatment for memory problems.~   "
84398|NCT01952691|"~     The main aim of this study was to find the initial effects of kinesiotaping on pain and~     joint alignment used in the conservative treatment of hallux valgus.~      22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping~     was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The~     main outcome measures were the pain hallux adduction angle. Kinesiotaping may be an~     effective treatment option in decreasing pain and deformity in hallux valgus deformity who~     are conservatively treated. In future studies this method might be shown in larger sample~     groups at longer periods of treatment comparing with alternative treatment approaches like~     exercise or orthotics.~   "
84399|NCT01952678|"~     The primary objective of this study is to determine if the diagnostic performance of~     DaTscan™ single photon emission computed tomography (SPECT) imaging is different in~     non-Caucasian subjects compared with Caucasian subjects with movement disorders.~   "
84400|NCT01952665|"~     A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over~     1 Month of Daily Wear~   "
84401|NCT01952652|"~     In this study, the aim is to compare the efficacy of single dose naproxen sodium and~     combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients~     undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more~     advantageous than naproxen alone.~   "
84402|NCT01952639|"~     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a~     major impact on our health care system due to increased morbidity and greater need for~     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to~     improve dietary intake of the elderly. Both whey and casein seem to offer an anabolic~     advantage over soy protein for promoting muscle hypertrophy. As a consequence it is assumed~     that (all) plant based proteins have less potent anabolic properties when compared with~     animal based proteins. However, there is little theoretical background for such assumptions.~      Objective: To provide evidence for the efficacy of wheat protein and wheat protein~     hydrolysate when compared with milk proteins (i.e. whey and casein) as a dietary protein to~     stimulate postprandial muscle protein synthesis in vivo in healthy older humans.~      Study design: double-blind, placebo-controlled intervention study Study population: 60~     healthy non-obese (BMI 18.5-30 kg/m2) older males (age: 65-80 y) Intervention: A protein~     beverage (350 mL) containing 30 g of whey, casein, wheat protein, or wheat protein~     hydrolysate or 60 g of wheat protein hydrolysate will be consumed (n=12 per group).~      Main study parameters/endpoints: Primary study parameters include muscle protein synthesis~     rates. Secondary study parameters include whole-body protein synthesis, breakdown,~     oxidation, and net balance.~      Hypotheses: We hypothesize that ingestion of wheat protein hydrolysate results in a greater~     muscle protein synthetic response when compared with the intact wheat protein due to its~     faster digestion and absorption. Furthermore, ingestion of wheat protein hydrolysate results~     in a higher muscle protein synthetic response when compared with casein, but lower when~     compared with whey protein. Ingestion of 60 g of wheat protein hydrolysate (amount of~     leucine equal to 30 g of whey protein) will result in a similar muscle protein synthetic~     response compared to ingestion of 30 g of whey protein.~   "
84403|NCT01952626|"~     Intrathecal administration of morphine is often used for control of postoperative pain.~     However, pruritus is one of the most common side effects of intrathecal morphine . Specific~     serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial~     opioid-induced pruritus. It was reported that palonosetron is more effective than~     ondansetron for prevention of postoperative nausea and vomiting. Therefore, the~     investigators evaluated the efficacy of prophylactic administration of ondansetron and~     palonosetron for the prevention of intrathecal morphine-induced pruritus.~   "
84404|NCT01952613|"~     Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to~     the Function Electrical Stimulation (FES) intervention and identifies the responders to the~     intervention. This study will improve our knowledge of FES intervention and help clinicians~     strategize the FES interventions more effectively based on the responders' gait~     characteristics, thus supporting the NINDS' fundamental goal of translating basic and~     clinical discoveries into better ways to prevent and treat neurological disorders.~   "
84405|NCT01952600|"~     The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic~     kidney disease (CKD) patients' priorities; assessing the comparative benefits of~     hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and~     providing tailored information to assist patients with identifying the best dialysis~     modality fit for their own unique circumstances and perspectives.~      The outcomes most relevant to patients (patient-centered) extend beyond those~     traditionally assessed in clinical research, with the relative importance varying across~     patient groups. A tailored decision aid based on these findings can improve patient~     decision-making processes regarding choice of dialysis modality.~   "
84406|NCT01952587|"~     Short title :~      X-linked biological response to HIV sensing: the ANRS EP 53 study.~      Main outcome :~      To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than~     uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in~     the risk of becoming infected by HIV-1.~      Secondary outcome :~      To directly demonstrate at a single cell level that the TLR7 c.32A>T SNP is responsible for~     a reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA.~      Short abstract (public dissemination) :~      Male and female display some differences in how their immune system responds to pathogens.~     This could be related to hormonal or genetic factors located on the X chromosome. This~     project aims at characterizing X-linked factors that can influence the innate immune~     response to HIV-1.~   "
84407|NCT01952574|"~     Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by~     open-label phase. To evaluate the effect of AMG 334 compared to placebo on the change from~     baseline in monthly migraine days~   "
84408|NCT01952561|"~     Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring~     containing 25 mg worn for 1, 2, 4, 8 or 12 months.~   "
84409|NCT01952548|"~     This study will test single doses of the study drug in increasing amounts to see if it is~     safe.~   "
84410|NCT01952535|"~     The objectives of this study is to determine the safety profiles, tolerability,~     pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy~     adult subjects.~   "
84411|NCT01952522|"~     This study is designed to determine if adding daily weighted braces on the unaffected ankle~     may benefit to patient who have returned home compare to a placebo intervention (ankle brace~     without weight).~   "
84412|NCT01952509|"~     This multicenter, observational study will evaluate the use and efficacy of~     RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to~     severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in~     accordance with the local label will be followed for 6 months.~   "
84413|NCT01952496|"~     The goal of this project is to design and validate a force-measuring platform that will~     measure the magnitude and duration of the load experienced by the lower extremities of~     individuals with a neuromuscular disability who use a stationary assisted standing device to~     increase their Bone Mineral Density.~   "
84414|NCT01952483|"~     Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D~     supplementation reverse the immune activation~      Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients~     and the effect of Vitamin D supplementation on reversing the cognitive impairment?~   "
84415|NCT01952470|"~     Patients who have undergone lung transplantation are at an increased risk of developing~     chest infections due to long-term medication suppressing the immune response. In other~     chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised~     mucolytic medication such as dornase alpha and isotonic saline are often used as part of the~     management of lung disease characterized by increased or retained secretions. These agents~     act by making it easier to clear airway secretions, and are currently being used on a~     case-by-case basis post lung transplantation.~      To the investigators knowledge, these agents have not been evaluated via robust scientific~     investigation when used post lung transplant, yet are widely used in routine practice.~     Patients post lung transplant must be investigated separately as they exhibit differences in~     physiology that make the clearance of sputum potentially more difficult when compared to~     other lung diseases. Lower respiratory tract infections are a leading cause of hospital~     re-admission post lung transplant. Therefore, this highlights the need for a randomized~     controlled trial. The aim of this study is to assess the efficacy of dornase alpha, compared~     to isotonic saline, in the management of lower respiratory tract infections post lung~     transplant. Investigators hypothesize that dornase alpha will be more effective than~     isotonic saline.~      The effect of a daily dose of dornase alpha and isotonic saline will be compared over a~     treatment period of 1 month. Patients admitted to hospital suffering from chest infections~     characterized by sputum production post lung transplant will be eligible for study~     inclusion. Patients will be followed up through to 3 months in total to analyze short-medium~     term lasting effect. Investigators wish to monitor physiological change within the lung~     non-invasively via lung function analysis whilst assessing patient perceived benefit via~     cough specific quality of life questionnaires. These measures will be taken at study~     inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed~     via patient symptom diaries, incorporating hospital length of stay and exacerbation rate.~     The outcomes of this study have the potential to guide clinical decision-making and~     highlight safe and efficacious therapies.~   "
84416|NCT01952457|"~     The objective of this clinical investigation is to evaluate the early and mid-term outcome~     (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX~     paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C&D~     femoropopliteal lesions.~   "
84417|NCT01952444|"~     Evaluate the safety and tolerability of intravenous (IV) ETI-204 alone and in the presence~     of IV and oral ciprofloxacin~   "
84418|NCT01952431|"~     A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring~     TLC (total lung capacity) compared to TLC measured by standard body plethysmography using~     the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized~     comparative study.~   "
84420|NCT01952405|"~     The purpose of this study is to test the hypothesis:~      Primary hypothesis: Participants in the dialectical behavior therapy group have greater~     reductions in the frequency and severity of suicidal and non-suicidal self-injurious~     behaviors compared to participants in the alternative treatment group.~      Secondary Hypotheses: Participants in dialectical behavior therapy group have improved~     treatment outcomes compared to participants in alternative treatment, including mental~     health service utilization, symptoms of borderline personality and depression symptoms,~     suicidal thought and hopelessness, disability, and quality of life.~   "
84421|NCT01952392|"~     Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome~   "
84422|NCT01952379|"~     Melasma is an acquired hyperpigmentary disorder that commonly affects women from Asia and~     Latin-America.There is evidence of subclinical inflammation supported by diffuse~     spectrometry and by prominent inflammatory cells in affected areas; however this infiltrate~     and its inflammatory mediators remains unexplored. Chronic inflammation induces~     melanogenesis and angiogenesis; thus, it could be linked to its recurrent nature.Therefore,~     the aim of this study is to describe the inflammatory cellular infiltrate, and the~     expression of main inflammatory and angiogenic mediators in this condition, as well as to~     explore its relationship with severity of disease.~      Using histological, histochemistry, immunohistochemistry, and quantitative real-time PCR, we~     evaluated melasma lesions from 20 healthy female patients with malar melasma without~     specific solar exposure or photoprotection measures within the previous 3 weeks and compared~     them to non lesional skin.~   "
84423|NCT01952366|"~     PRODE is a Norwegian multicentre study investigating the prognosis of depression in the~     elderly. The study has included 169 patients who will be followed with assessments after one~     and three years.~      The study hypothesis is that elderly patients referred to specialist health service have a~     poor long term prognosis.~   "
84424|NCT01952353|"~     Whether preoperative transarterial chemoembolization can prolong survival for the resectable~     hepatocellular carcinoma remains controversial, particularly in patients with portal vein~     tumor thrombi. This study designs to systematically identify and summarize the effect of~     preoperative TACE for resectable HCC with portal venous invasion.~   "
84425|NCT01952340|"~     The World Health Organization has deemed high blood pressure as a global crisis because it~     is the number one risk factor associated with most deaths worldwide. Therefore, the need for~     effective and desirable treatment options is vitally necessary. The purpose of the current~     investigation is to determine the efficacy of a new therapeutic strategy: flaxseed. The aim~     is to determine the efficacy of consuming milled flaxseed every day for 6 months on the~     reduction of blood pressure in individuals newly diagnosed with high blood pressure yet to~     receive any blood pressure lowering medications. Secondary objectives are to understand how~     flaxseed at the molecular level can reduce blood pressure. The study hypothesis is that the~     flaxseed group will exhibit significant reductions in blood pressure and therefore not~     require any blood pressure lowering medication. The aim is to provide knowledge on a new~     therapeutic strategy to help manage high blood pressure.~   "
84426|NCT01952327|"~     This is a research study examining the safety of a new, automated pump for the drainage of~     fluid in the chest cavity which is caused by cancer (also known as malignant pleural~     effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device~     is safe and effective in the management of patients with MPE. The study will try to identify~     what kind of problems may arise from using the device, how often they happen, and how severe~     they are if they occur.~   "
84427|NCT01952314|"~     This study is to investigate whether naftopidil is effective or not for the spontaneous~     passage of ureteral stones with sizes of 3 to 10 mm.~   "
84428|NCT01952301|"~     A split-mouth study comparing soft tissue augmentation results using free gingival graft~     (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT)~     around teeth with insufficient (< 2mm) KT.~   "
84429|NCT01952288|"~     Study of simvastatin in Iraq/Afghanistan Veterans with multiple blast exposure and mTBI. The~     study will measure substances in cerebrospinal fluid (CSF) that are related to dementing~     disorders.~   "
84430|NCT01952275|"~     This study investigates the genetic architecture of Neutrophil-Mediated Inflammatory Skin~     Diseases. After collecting informed consent, all patients' clinical phenotype is graded at~     inclusion with a detailed case report form and a discovery cohort formed based on the~     certainty of diagnosis. The DNA of patients in the discovery cohort is analyzed by whole~     exome sequencing which identifies all protein-coding genetic variants. Subsequently,~     statistical burden tests are going to identify enrichment of rare coding genetic variants in~     patients affected by Neutrophil-Mediated Inflammatory Skin Diseases.~      The ultimate goal is to reveal the responsible gene(s) that may then be targets for clinical~     intervention.~   "
84431|NCT01952262|"~     Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically~     ill patients admitted in a teaching hospital intensive care unit will be evaluated with~     diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical~     course of these patients.~      Vascular surgery patients (aortic abdominal surgery) might also be included and assessed~     with diaphragm ultrasound before and after surgery irrespectively of the need of intensive~     care unit. On December 2014 the Etical committee approved an amendment to include the~     possibility to study elective aortic abdominal surgery patient to assess the relationship~     between surgery related diaphragmatic dysfunction and postoperative respiratory~     complications.~   "
84432|NCT01952249|"~     This is a Phase 1b/2 study of paclitaxel plus demcizumab in subjects with platinum resistant~     ovarian, primary peritoneal or fallopian tube cancer.~   "
84433|NCT01952236|"~     This study seeks to develop and then perform a controlled efficacy Randomized Controlled~     Trial assessing tobacco abstinence of a best-practices Web-based smoking cessation~     intervention combined with a Mobile intervention. Study participants are randomized to one~     of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis~     is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.~   "
84434|NCT01952223|"~     The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic~     radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in~     patients with high-risk localized prostate cancer (with a stringent selection of patients~     with at least 2 high-risk features), in a 2 by 2 factorial trial.~   "
84435|NCT01952210|"~     In this randomized pilot study, a nutritional consultation combining exercise program is~     planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant~     chemoradiation. The purpose of this study is to determine the effects of nutritional and~     exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant~     chemoradiation.~   "
84436|NCT01952197|"~     1. Hypothesis The early elevation of the lower extremities during out-of-hospital~     cardiopulmonary resuscitation increases survival to one month by improving cardiac preload~     and blood flow to the heart and brain during chest compression.~   "
84437|NCT01952184|"~     The survival rate (and embryo quality) of donor oocytes with two commercially available~     devices.~   "
84438|NCT01952171|"~     Recent advances in genomic techniques are making possible a new wave of genetic discovery in~     congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa~     at frequencies similar to the rest of the world. In this application, we propose to utilize~     the unique advantages of Sub-Saharan Africa - a combination of the most genetically diverse~     populations in the world and of diminished environmental background effects (i.e. low~     prevalence of smoking, alcohol abuse, obesity in comparison to western countries) - to~     better understand the genetic basis for congenital heart disease. We will couple next~     generation genomic techniques with more traditional gene discovery methods to investigate~     CHD in two African countries: Uganda and Nigeria. The inclusion of syndromic and~     non-syndromic CHD observed in these populations as well as careful phenotyping (including~     echocardiography) will greatly enhance our potential to provide insight into the genetic~     architecture of CHD in African populations. To accomplish this, we plan to enroll families,~     in whom members have congenital heart malformations consistent with an error of early human~     development in our research protocol. Patients will be enrolled at the Uganda Heart~     Institute in Kampala, Uganda, and at the Department of Pediatrics, College of Medicine,~     University of Lagos, Nigeria, with the potential to include other African sites. High~     throughput genomic studies will be done at the NIH.~   "
84439|NCT01952158|"~     Acquisition and transmission of MDROs in healthcare facilities is a major patient safety~     problem, afflicting in particular the antibiotic-exposed and immunodeficient patient~     populations. MDRO-colonized patients require isolation to reduce the risk of transmission to~     other patients, and frequently develop infections from their colonizing organisms.~      Most clinically relevant MDROs are carried in the gastrointestinal tract; thus perirectal~     cultures are frequently the surveillance method used to screen for these pathogens.~     Surveillance to identify MDRO colonization allows for anticipation and timely initiation of~     effective treatment of patients who develop infection.~      The precise modes of transmission within hospitals are not known, but contamination of the~     hands of healthcare personnel, patient care equipment, and the healthcare environment are~     thought to play major roles in transmitting MDRO. Suboptimal hand hygiene can lead to~     transmission on the hands of staff to other patients or colonization of their own~     gastrointestinal tract. Few studies have investigated intestinal colonization of healthcare~     professionals. Transmission of bacteria by healthcare personnel is thought to occur~     primarily via contaminated hands; we wonder whether gastrointestinal carriage by healthcare~     personnel also plays a role in nosocomial spread.~      This study will screen a self-referred convenience sample of 400 healthcare personnel who~     have contact with patients or patient culture specimens for fecal carriage of MDRO at one~     point in time. A control group of 400 NIH employees or contractors who do not have contact~     with patients or patient specimens will also be screened. Samples will be linked to~     questionnaires to assess the exposure of staff members to patients or culture specimens with~     known MDRO colonization or infection. We will use molecular typing techniques to link~     healthcare personnel isolates to patient or environmental isolates. Finally, the study will~     be conducted in such a way as to preserve to the greatest extent possible the anonymity of~     volunteers, using a system of alphanumeric identifiers and unmanned drop boxes for specimen~     collection.~   "
84440|NCT01952145|"~     This trial is conducted globally. The aim of the trial is to compare the efficacy and safety~     of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes~     mellitus.~   "
84441|NCT01952132|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.~   "
84442|NCT01952119|"~     This study will assess whether adding a secure message reminder to routine care improves the~     percentage of patients who complete a follow-up appointment with a new, documented blood~     pressure reading.~   "
84443|NCT01952106|"~     The main purpose of this study is Investigating the effectiveness of distraction by~     evaluating the children's perception of pain during venepuncture.~   "
84444|NCT01952093|"~     Despite the remarkable achievements in neonatal survival of preterm infants with very low~     birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have~     produced little change in their prevalence of severe developmental disability and the rate~     of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit~     hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills~     and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs~     developed for preterm infants in Western societies were shown to have short- to long-term~     benefits in certain cognitive functions, however rare studies have investigated intervention~     effect at school age and explored plausible neurological pathway for effective intervention.~     This three-year study is therefore aimed to extend our previous research to longitudinally~     examine the effectiveness of three intervention programs (clinic-based intervention program~     [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW~     preterm children in Taiwan at seven years of age.(The intervention had been delivered from~     birth to one year of corrected age in the previous study. Intervention will not be given in~     this study.)The CBIP and HBIP contained similar child- and parent-focused services as well~     as interaction activities but were respectively delivered at clinic for the CBIP and at home~     for the HBIP. A total of 178 VLBW preterm infants have been randomly assigned to the CBIP,~     HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal~     birth weight have also been included to serve as the reference group for comparison of~     developmental outcomes. Effectiveness examined will include child and parent outcomes. The~     long-term effect of early intervention for preterm children will provide important~     information to help medical professionals and public policy makers to develop effective~     intervention for Taiwanese preterm children who are at risk of developmental disorders.~   "
84445|NCT01952080|"~     This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide~     in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into~     an observational cohort who will receive standard of care. Three doses of teduglutide are to~     be investigated for 12 weeks. All subjects will be screened prior to the start of treatment~     (SOT) to establish baseline characteristics including safety, eligibility and nutritional~     support parameters.~   "
84446|NCT01952067|"~     The primary aim of the study is to compare migration of the cemented Corail stem~     representing polished surfaced versions of the femoral stem. Two different methods will be~     used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis~     (RSA) will be used in migration measurements.~      Furthermore pain, postoperative outcome and patient satisfaction will be assessed.~   "
84447|NCT01952054|"~     The goal of this clinical research study is to learn if denosumab in combination with a~     hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with~     breast cancer that has spread to the bone. The safety of this combination will also be~     studied.~   "
84448|NCT01952041|"~     The study is a three year research project whose aims are to design and test a~     state-of-the-science smartphone Ecological Momentary Assessment (EMA) and sensor~     technologies to provide mobile monitoring of schizophrenia to detect early signs of relapse.~     The proposed system will be used to continuously capture multidimensional behavior as it~     occurs in real-time and in real-world environments, detect individual early warning signs,~     and trigger targeted interventions that may mitigate the severity of relapses or prevent~     their recurrence altogether. Mobile sensors include paralinguistic aspects of speech,~     physical activity and location, and sleep. The first hypothesis is that mobile sensing and~     EMA techniques will capture early behavioral warning signs. The second hypothesis is that~     machine learning, coupled with user input, will enable development of individualized~     predictive risk signature models. The third hypothesis is that automated system patient~     and provider functions will help prevent psychotic relapses.~   "
84449|NCT01952028|"~     Laminin alpha-2 (LAMA2)-related muscular dystrophy (LAMA2-MD, Merosin Deficient CMD) is a~     form of congenital muscular dystrophy (CMD). A person with LAMA2-MD will have changes on~     brain imaging (MRI), a decrease or absence of the protein merosin (laminin 211) on muscle or~     skin biopsy and changes in the LAMA2 gene that are inherited from both parents. Several~     studies have described the changes on brain MRI. Brain changes on MRI do not correlate with~     the partial reduction or absence of merosin on muscle or skin biopsy. 8-30% of people with~     LAMA2-MD develop seizures. The types of seizures, electroencephalogram changes and common~     treatment regimens have not been characterized. This study will review the magnetic~     resonance imaging (MRI) changes, determine whether certain brain MRI changes are linked to~     seizures and define the common seizure treatment regimens.~   "
84450|NCT01952015|"~     The purpose of this study is to assess efficacy and safety data of secukinumab in Japanese~     subjects with generalized pustular psoriasis (GPP). This study is expected to support the~     filing of secukinumab in the indication of pustular psoriasis in Japan.~   "
84451|NCT01952002|"~     The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic~     responses during an inspiratory muscle training session during a single cardiopulmonary~     rehabilitation session program. An electrocardiogram will be continuously recorded and the~     heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately~     after a single inspiratory muscle training (IMT) session, consisting of two series of 15~     cycles, with one-minute intervals between sets and an initial load of at least 30% of the~     initial maximal inspiratory pressure (MIP).~   "
84452|NCT01951989|"~     Rational: Imiglucerase has been used to treat Gaucher disease since 1997 but data about its~     pharmacokinetics have been partial; investigators know that imiglucerase undergoes a quick~     clearance from plasma compartment following the infusion (1/2 life: 1-6 min, from tissue:~     <24h), an observation apparently contradictory with usual infusion rhythm (one infusion~     every two weeks). Furthermore, by going by GD response, the rhythm of Infusion is sometimes~     diminished (for example, every 3 or 4 wks) without pharmacological rational ; In parallel,~     investigators demonstrated that monocytes represent a satisfactory surrogate of GD target~     cells and that enzyme activity into monocytes varies between individuals.~      Our hypothesis is that enzyme activity into monocyte compartment could be different and~     could be related to GD response.~      Primary purpose: to evaluate the pharmacokinetics of Imiglucerase activity into target~     cellular compartment depending on dose and frequency of infusions.~      Secondary purposes : 1) to establish a possible relationship between the intra-monocytic~     activity of glucocerebrosidase and the clinical and biological activity of Gaucher disease~     and to define a possible threshold value of enzyme activity; 2) to establish a better~     correlation with known biomarkers of disease (routine markers and markers recently~     identified), which would better predict and / or monitor response to treatment ; 3) to~     compare the residual and natural rate of activity enzyme intra-monocytic for untreated~     patients (low severity disease).~   "
84453|NCT01951976|"~     The purpose of this study is to determine whether it might be practical and useful to~     investigate the effectiveness of yoga classes in relieving joint pain associated with the~     use of a class of medications known as aromatase inhibitors.~   "
84454|NCT01951963|"~     The proposed trial is a prospective, double blinded, randomized control trial with the~     primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease~     the total narcotic requirements of pediatric patients requiring intravenous analgesia in an~     urban emergency department (ED) compared to a group of patients who receive morphine alone~     for pain management. Patients are randomized to receive either a single bolus of ketamine~     (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will~     be accomplished using morphine. Patient, family member, and research staff pain scores will~     be recorded, until 3 hours post study medication administration. Family members are~     contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital~     discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic~     equivalents will be calculated for up to 3 hours post study medication administration and~     compared between the ketamine and morphine groups.~   "
84455|NCT01951950|"~     Emergence hypertension is a common occurrence in patients emerging from general anesthesia.~     This elevation of arterial pressure is particularly concerning in patients undergoing~     craniotomy due to increased risk of morbidity and mortality in patients with altered~     intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic~     changes associated with emergence from anesthesia can improve patient safety, especially in~     the neurosurgical patient.~      Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining~     blood pressure within goal range in the setting of emergence hypertension after craniotomy.~   "
84456|NCT01951937|"~     In the FINS study we test - in a randomized non blinded intervention study- the hypothesis~     that increased intake of herring and mackerel will improve cognitive performance of children~     aged 4 years to 5 years 8 months in the Munich area (Germany), who habitually consume little~     fish.~   "
84457|NCT01951924|"~     The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use~     liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment~     of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.~   "
84458|NCT01951911|"~     To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion~     improves analgesia in patients with neuropathic cancer pain.~   "
84460|NCT01951885|"~     This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and~     methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate~     in patients with hematologic malignancies undergoing allogeneic hematopoietic cell~     transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a~     calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less~     toxicity than standard dose methotrexate. It is not yet known, however, whether this~     combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more~     effective than tacrolimus and standard dose methotrexate in preventing GVHD.~   "
84461|NCT01951872|"~     Recent research has shown that some individuals become addicted to or dependent on caffeine~     and are unable to quit or reduce caffeine consumption despite a persistent desire to do so.~     The aims of the current study are to characterize caffeine use among individuals with~     physical or psychological dependence on caffeine and evaluate a manual-based intervention to~     promote caffeine reduction and cessation.~   "
84462|NCT01951859|"~     This is a study whose primary objective is to assess the effectiveness of Neuropathy/Ulcer~     Cream in the promotion of healing skin fissures plantar foot ulcers and as a moisturizer to~     prevent dry skin turning into ulcers as compared with a placebo cream containing the same~     vehicle as Neuropathy/Ulcer Cream without the active ingredients (Control).~   "
84463|NCT01951846|"~     The primary objective of this study was to determine the maximum tolerated dose (MTD) of~     BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events.~     Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and~     pharmacodynamics.~   "
84464|NCT01951833|"~     The current dream in CF research is to discover safe drugs that correct the basic defect and~     prevent lung disease, allowing patients without significant lung damage to live nearly~     normal lives with a dramatic increase in life expectancy and without the burden of current~     treatment. The compound VX-770 (Ivacaftor Ò) is hoped to be the first milestone along this~     way. Progression of lung disease is now so gradual in many centres that sensitive indicators~     of early lung disease (small airways disease) are critically needed to assess the effects of~     such new treatments. In this context, assessment of ventilation inhomogeneity by the~     measurement called Lung clearance index (LCI) seems to be the most promising tool. However,~     to get approval by health authorities, new measures used in drug evaluation need to fulfill~     strict criteria. For LCI, the investigators still need to prove its long term significance:~     How well does the LCI measurement predict the long term lung disease course? Therefore, in~     this study the investigators want to measure LCI at baseline in a large patient cohort and~     establish how well it predicts the patients' disease course over the next 2 years.~   "
84465|NCT01951820|"~     The efficacy of the topical anesthetics will be determined by how much pain the patient felt~     (using a Heft-Parker pain analog scale) upon needle penetration.~   "
84466|NCT01951807|"~     Subjects that have received medical treatment for ovarian cancer can be both physically and~     emotionally demanding for patients. The purpose of this study is to determine whether two~     common pyschological interventions (Communication Skills Intervention and Supportive~     Counseling) may improve the well-being of ovarian cancer patients compared to usual care.~   "
84467|NCT01951794|"~     Validate a promising community survey methodology for evaluating the Prevention of Mother to~     Child Transmission (PMTCT) program effectiveness against a gold standard cohort design and~     to identify individual- and facility-level characteristics associated with HIV-free survival~     among HIV-exposed infants.~   "
84468|NCT01951781|"~     Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and~     biological markers in the infection initial phase .The aim of this study is to determine the~     performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial~     infection (NI) in preterm newborns.~      METHODS :~        -  Monocentric prospective study including preterm newborn infants (<37 weeks of~          gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal~          intensice care unit (Neonatal intensive care unit of Montpellier, France).~        -  Patients will be enrolled in the study after informed consents. Rapid and automated~          CD64 measurment will be realized during the conventional blood sample including~          C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.~        -  Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded~          the result of CD64. Patients will be then classed in three groups using CDC criteria~          (center for disease control) : 1-no infection, 2-infection, 3-possible infection during~          the multidisciplinary staff. Specificity, sensitivity, negative and positive value of~          CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.~           153 patients are needed in the study enrolled during a period of 12 months.~      PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial~     infections in neonates.CD64 allow to integrate in a decision algorithm with the~     determination of the best cut-off value to faster processing nosocomial infections and could~     help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64~     should be readily available in our unit.~   "
84469|NCT01951768|"~     The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen~     sponge) in combination with antibiotics is safe and effective in treating moderate and~     severe diabetic foot infections.~   "
84470|NCT01951755|"~     An open-label, non randomized clinical trial of Tarceva as single agent in progressed~     non-small cell lung cancer patients.~   "
84471|NCT01951742|"~     The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment~     of Crow's Feet.~   "
84497|NCT01951391|"~     Up to 20 volunteers will be recruited to evaluate the microbial environment on their~     forearms. Following informed consent, bacterial swabs will be obtained on day 0 from the~     forearms of all subjects. Their forearms will then be washed with one of the study~     cleansers. Subjects will then be instructed to return at different timepoints over the next~     several days for repeat bacterial swabbing of their forearms. For the first 10 participants,~     these timepoints will be every 24 hours for a total of 3 days. For the following~     participants, these timepoints will be at 10 minutes, 6 hours, and 24 hours after the wash.~     DNA will be extracted from all swabs and bacterial diversity evaluated by 16S~     pyrosequencing.~   "
84740|NCT01948206|"~     The purpose of the study is to determine whether prolonged paced QRS duration is a marker of~     sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).~   "
84472|NCT01951729|"~     Glucose-dependent insulinotropic polypeptide (GIP) is a hormone produced in the intestine.~     It is released immediately after meal ingestion and increases insulin release. This, in~     turn, helps reduce blood glucose levels. This circuit does not work properly in humans with~     type 2 diabetes mellitus (T2DM).~      We have previously shown that a peptide called xenin-25 can amplify the effects of GIP on~     insulin secretion in humans. However, xenin-25 no longer does this when humans develop T2DM.~     Thus, it is important to understand how xenin-25 works in humans without T2DM so we know why~     it does not work in humans with T2DM.~      Acetylcholine is molecule produced by specific types of nerves. The effects of acetylcholine~     can be blocked by a drug called atropine. We have previously shown in mice that atropine~     prevents the ability of xenin-25 to increase the effects of GIP on insulin release. The~     purpose of this clinical trial is to determine if atropine also blocks the effects of~     xenin-25 in humans without T2DM. If it does, then impaired acetylcholine signaling may be~     one of the reasons humans develop T2DM and it could be possible to develop drugs that bypass~     this defect and increase insulin release in humans with T2DM.~   "
84473|NCT01951716|"~     Glucose-dependent Insulinotropic Polypeptide (GIP) and xenin-25 are peptide hormones~     produced/released from your intestines and help regulate blood sugar levels after you eat.~     We have previously performed studies in humans that measured the effects of xenin-25 and GIP~     (alone and together) on blood sugar levels. One study was conducted with an intravenous~     infusion of glucose but without ingestion of a meal. In this study, xenin-25 increased the~     effects of GIP on insulin secretion- but only in humans without type 2 diabetes mellitus~     (T2DM). A second study was conducted in conjunction with ingestion of a meal. In this study,~     xenin-25 reduced blood glucose levels by delaying gastric emptying and this effect was~     similar in humans with and without T2DM. A variety of studies that we have performed suggest~     that xenin-25 works by activating nerves. A specific nerve called the vagus nerve plays an~     important role in regulating insulin secretion. This study will determine if the vagus nerve~     (which was disrupted if you had a vagotomy) is needed for the effects of xenin-25 on insulin~     secretion and/or gastric emptying.~   "
84474|NCT01951703|"~     To evaluate the impact of a new contact lens hydration process~   "
84475|NCT01951690|"~     This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a~     focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer~     (NSCLC). NSCLC with a KRAS mutation is required for study entry and subjects will be~     enrolled into 1 of 4 cohorts based on the status of their INK4a/Arf and p53 mutations. The~     purpose of this study is to demonstrate if VS-6063 (defactinib) improves PFS within each~     cohort. The safety and tolerability of VS-6063, tumor response rate, progression free~     survival and overall survival will also be assessed. The pharmacodynamic effects of VS-6063~     (defactinib) will be examined in a tumor biopsy and a blood sample.~   "
84476|NCT01951677|"~     There is a need for more effective and better-tolerated hepatitis B vaccines for low~     responder high-risk populations including patients with renal impairment and/or diabetes~     mellitus and those aged over 40 years. Several approaches are available to enhance the~     potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens,~     replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine~     antigen. A combination of these strategies is being tested in this study to identify the~     most promising candidate approaches to take forward into advanced clinical development~   "
84477|NCT01951664|"~     Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI).~     This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.~   "
84478|NCT01951651|"~     The purpose of this study is to examine the effect of exenatide on liver and heart~     (myocardial) fat and inflammation.~   "
84479|NCT01951638|"~     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate~     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard~     diuretic and comorbidity treatment for heart failure with preserved ejection fraction~     (HFpEF)~   "
84480|NCT01951625|"~     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate~     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard~     therapy for heart failure with reduced ejection fraction (HFrEF).~   "
84481|NCT01951612|"~     Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic~     damage due to occlusion in penetrating arteries. Although ischemic white matter disease~     (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment,~     particularly on measures of executive function, attention, and memory. This impairment is~     attributable to diffuse damage affecting network connections.~      While there are many studies concerning rehabilitation of motor function and language in~     patients with large focal strokes, few studies have addressed attentional and executive~     functions. To our knowledge, there are no such studies on iWMD. In this study, patients will~     be randomized to a novel intervention for improving executive function and a control~     condition matched for therapist exposure. Patients will be assessed pre-intervention,~     post-intervention, and at long-term follow-up using a battery of behavioural and~     neuroimaging tasks. We predict that the novel intervention will be associated with improved~     executive function, as assessed behaviourally, and improved frontal network function, as~     assessed through neuroimaging markers.~   "
84482|NCT01951599|"~     To determine the relative bioavailability of different oral formulations of AZD9291 and the~     effect of food in healthy volunteers.~   "
84483|NCT01951586|"~     This randomized phase 2 trial is studying the effect of adding denosumab to standard~     chemotherapy in the treatment of advanced lung cancer.~   "
84484|NCT01951573|"~     The purpose of this study is to demonstrate non-inferiority of a new daily disposable~     multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA~     MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).~   "
84485|NCT01951560|"~     The purpose of the first part of this study is to determine the safety and tolerability of~     ascending doses of valproic acid (also known as Depacon) administered as intravenous~     infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects.~      The second part of the study will also be to determine the safety and tolerability of single~     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic~     shock.~   "
84486|NCT01951547|"~     Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss,~     bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian~     population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for~     periodontitis and subsequently a two-way relationship between diabetes and periodontitis was~     proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction~     of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and~     Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque~     have been reported to be insulin antagonists that disturb binding of insulin to its~     receptors and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics~     promotes more pathogenic bacteria into the subgingival microenvironment making them more~     susceptible to chronic periodontitis. Studies however differ in the types of periodontal~     pathogens present in these pockets. At the same time, very few studies have quantified them.~     This study proposes to investigate the effect that non-surgical periodontal therapy (NSPT)~     has on the periodontal parameters, HbA1c levels, microbiological profile and CRP levels of~     T2D patients with chronic periodontitis as compared to oral hygiene education (OHE)alone.~   "
84487|NCT01951534|"~     This is an intervention development and pilot study whose purpose is to determine the~     feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide~     preliminary data on its impact on decisional outcomes.~      The primary aim of this study is: Is the intervention trial feasible? The purpose is to~     develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is~     important that this trial provide evidence of feasibility. The investigators will define~     feasibility as the rate of study acceptance and participation.~      The secondary aim of this study is:  Is the BRDA acceptable and used? The team will~     evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict~     uptake and use. The investigators anticipate that, due to interest in the topic, the~     majority of women will access the website.~      An additional secondary aim of this study is: What is the impact of BRDA on BR knowledge,~     attitudes about BR, decisional conflict, preparedness and completeness of preparation,~     anxiety, and discussion with oncologist? The purpose is to calculate effect sizes for a~     larger randomized trial.~   "
84488|NCT01951521|"~     Investigators study whether addition of a preoperative radiation boost increases~     pathological complete response rates in patients with locally advanced rectal cancer treated~     with pre-operative chemoradiation.~   "
84489|NCT01951508|"~     The purpose of this study is to investigate effects of methylphenidate, modafinil, and~     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) on emotion-processing and cognitive~     performance using functional magnetic resonance imaging (fMRI) techniques. The primary~     hypothesis is that these psychostimulants differentially affect processing of emotional~     stimuli and potentially leading to alterations in social cognition and behavior.~   "
84490|NCT01951482|"~     This is a multi-center phase II randomized controlled study to assess the efficacy of~     Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from~     non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also~     PFS ,DCR and OS.The side effect is evaluated as well.~   "
84491|NCT01951469|"~     This is a multi-center phase II randomized controlled study to assess the efficacy of~     Gefitinib alone and Gefitinib combinating with Pemetrexed/cisplatin on patients with brain~     metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by~     intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.~   "
84492|NCT01951456|"~     The purpose of this study is to determine whether resistance training can aid smoking~     cessation.~   "
84493|NCT01951443|"~     The purpose of the study is to evaluate the acute effect of a standardized extract of KRG~     (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial~     stiffness and blood pressure, as measured by the following parameters: aortic augmentation~     index, peripheral blood pressure, central blood pressure~   "
84494|NCT01951430|"~     The purpose of this study is to observe the number of new cases of infections per population~     in a given time period and their characteristics in a pathology (myelodysplastic syndrome,~     MDS)that involves ineffective production (or dysplasia) of a class of blood cells.~   "
84495|NCT01951417|"~     This is an open-label, multi-center study to be conducted in the United States. The study~     will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in~     conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30~     (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible~     for treatment with Epiduo® in accordance with the currently approved product labeling and~     who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the~     study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts,~     cutaneous irritation assessment, end of study treatment questionnaire, photographic~     evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function~     assessment, treatment compliance, and adverse event assessment.~   "
84496|NCT01951404|"~     Kidney patients on dialysis commonly die because of heart disease. One of the biggest~     problems in their hearts is that the muscle wall of the heart thickens. This makes it less~     efficient. We found in patients with mild kidney disease that a drug normally used to treat~     gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of~     their heart wall. In this new study we aim to find out if this benefit of allopurinol also~     occurs in severe kidney patients i.e. those on regular dialysis. We also are trying to~     figure out the best dose of allopurinol to use. To do this we are planning a study where we~     will recruit patients with kidney disease who are on dialysis. The 1st phase of the trial~     will be to determine the best dose of allopurinol to use and the second phase will be to do~     a clinical trial where patients will be randomly allocated to either this optimum dose of~     allopurinol or a dummy medication (placebo) and will receive one year of treatment. They~     will have a special scan of the heart using an MRI machine to measure the extent of~     thickening of their heart muscle before they start on treatment and will have a further MRI~     scan when their one year treatment finishes.~      Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7~     visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will~     involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13~     month period.~   "
84498|NCT01951378|"~     The primary objective will be, in an open-label randomized trial, a comparison of emergency~     department (ED) length of stay (LOS) between children experiencing acute asthma treated with~     two different nebulizers. Secondary outcomes will include admission rates, hospital LOS,~     need for additional therapies, transfers to a higher level of care, side-effects, and~     unscheduled return visits~   "
84499|NCT01951365|"~     Spinal intradural schwannoma detected incidentally increased recently. Because there is~     little knowledge about natural history of spinal schwannoma, there is no consensus of~     treatment. Our hypothesis is as follows;~        1. Some schwannomas keep growing, the others do not.~        2. Foraminal schwannomas do not usually grow.~      The investigators analyzed natural history and characteristics of 56 spinal schwannomas~     observed initially with accurate and reliable methods. Here the investigators displayed~     growing pattern and differential point of spinal schwannoma.~   "
84500|NCT01951352|"~     In this study we will test the ability of different commercially available hand soaps to~     effect the amount of anti-microbial peptides present on the surface of the human skin after~     washing with these soaps. Based on our experiments on pig skin, we expect the amount of~     antimicrobial peptide expression to decrease after using these different soaps.~   "
84501|NCT01951339|"~     The goal of this study is to examine whether sitagliptin, an agent which enhances the action~     of hormones that control the release of insulin and is already in clinical use for type 2~     diabetes, might also improve functional exercise capacity.~      Specific aims:~      1. To test whether sitagliptin will improve functional exercise capacity in persons with~     type 2 diabetes compared to glimepiride.~      1a. The primary outcome will be peak oxygen consumption (VO2peak) and oxygen uptake kinetics~     (VO2 kinetics).~      1b. Secondary outcomes include cardiac function, endothelial function and tissue oxygen~     saturation (STO2) as well as health-related quality of life.~      2. To evaluate the impact of sitagliptin on muscle mitochondrial function 2a. The primary~     outcome to address this aim will be 31P measurements (phosphocreatine, free inorganic~     phosphate, adenosine triphosphate peaks, adenosine diphosphate and pH)~      Impact: Novel approaches are needed to decrease excess cardiovascular morbidity and~     mortality in diabetes. Diabetes impairs cardiovascular fitness and thereby mortality. A~     demonstration that sitagliptin improves cardiovascular fitness, (and possibly mitochondrial~     function) will provide important new data pertinent to the management of diabetes and~     pre-diabetes.~   "
84502|NCT01951326|"~     The investigators hypothesize that RHB-104 will have greater efficacy than placebo in~     Crohn's disease.~   "
84503|NCT01951313|"~     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and~     vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of~     fruits and vegetables results in limited availability of certain nutrients found in these~     foods such as carotenoids. Dietary carotenoids have health beneficial properties and are~     known to fight against disease. Eggs are known to be a good source of carotenoids and eggs~     may improve the absorption of carotenoids found in co-consumed fruits and vegetables.~     Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will~     increase carotenoid absorption.~   "
84504|NCT01951300|"~     This study investigates whole-body distribution kinetics of intravenously administered~     Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT).~     Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.~   "
84505|NCT01951287|"~     Blood sugar and insulin levels after a meal may be altered by the food and beverages a~     person consumes. Keeping a healthy blood sugar level may help prevent and manage type 2~     diabetes and related diseases. This study will look at how drinking different common~     beverages (milk, low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal~     changes blood sugar and insulin levels.~   "
84506|NCT01951274|"~     A study of a several doses of a novel treatment for chronic itch compared to placebo for~     patients whose condition has not responded to other treatments~   "
84507|NCT01951261|"~     To determine if an early assisted discharge program for acute exacerbations of COPD~     (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient~     in terms of use of health care resources, that a home care provided by hospital respiratory~     nurses and pulmonologists.~   "
84508|NCT01951248|"~     The purpose of this study is to investigate the effect of 3 months of continuous positive~     airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe~     cases in patients with chronic kidney disease. The effect is evaluated on blood pressure~     levels, particularly nocturnal blood pressure, both central and peripheral, and renal~     function, including the kidneys treatment of salt and water.~      Hypothesis:~        1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure~          during the day more accurately than peripheral 24-h blood pressure measuring because~          the measurement is painless and does not interfere with the patient activities during~          the daytime or nighttime sleep.~        2. Central blood pressure is elevated in patients with OSA and falls during treatment with~          CPAP.~        3. The renal tubular function relating to the treatment of water and sodium is abnormal in~          patients with OSA with increased tubular absorption of water via the U-aquaporin 2~          (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during~          treatment with CPAP.~      4 Quality of life is improved during treatment with CPAP.~   "
84509|NCT01951235|"~     This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus~     placebo. The study will be performed in subjects with type 2 diabetes either naive of~     treatment or previously treated with an oral monotherapy excluding thiazolidinedione.~   "
84510|NCT01951222|"~     Recent large clinical studies have demonstrated the interest of LAMA therapy in the~     management of asthma, when compared to LABA.~      V0162 is a compound with a very long lasting bronchodilator effect when compared to~     reference treatment in non-clinical models and in COPD patients. Secondary properties of~     V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic~     compound and could bring option in the treatment obstructive lung disease. The objective of~     the study is to assess the bronchodilator properties of V0162 during 8 days in adult~     patients with asthma usually treated with ICS and LABA. The study is a randomised,~     double-blind, placebo-controlled, 3-period crossover, preceded by an open-label~     active-control period before randomisation.~   "
84511|NCT01951209|"~     Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States~     veterans. Cirrhosis is associated with impaired antibody responses and increased risk of~     bacterial infections. We have recently identified that cirrhosis is associated with~     abnormalities of memory B-cells, cells that make antibodies and help protect against~     bacterial infections. We have identified that chemicals associated with gut bacteria might~     play a role in causing these B-cell abnormalities. It is well known that gut bacteria have~     increased access to the blood in individuals with cirrhosis, a process called bacterial~     translocation. We hypothesize that reducing bacteria counts in the gut by using~     poorly-absorbed antibiotics (also known as selective gut decontamination) will partially~     reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.~   "
84512|NCT01951196|"~     A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of~     fall in blood pressure during nighttime) is a strong predictor for the risk of~     cardiovascular disease and mortality in patients with hypertension. Three factors seem to~     affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA)~     or the way ambulatory blood pressure is monitored.~      The aim of this study is to analyse the importance of these three factors on nighttime~     bloodpressure.~      Hypothesis:~      Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in~     blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is~     painless and does not interfere with activities during the daytime or night-time sleep~      In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy~     subjects.~      In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the~     severity of OSA, the severity of kidney disease, and blood pressure during daytime.~   "
84513|NCT01951183|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients~     treated with a stable dose of metformin.~   "
84514|NCT01951170|"~     This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in~     patients with active moderate to severe rheumatoid arthritis. Participants will receive a~     subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment~     is 24 weeks.~   "
84515|NCT01951157|"~     A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in~     comparison to docetaxel for the treatment of unresectable non-small cell lung cancer~     (NSCLC)patients~   "
84516|NCT01951144|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time~     course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic~     activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of~     PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic~     interaction between PF-06372865 and lorazepam will be evaluated.~   "
84517|NCT01951118|"~     Olfactory identification deficits occur in patients with Alzheimer's disease (AD), are~     associated with disease severity, predict conversion from mild cognitive impairment (MCI) to~     AD and are associated with healthy elderly subjects developing MCI. Odor (olfactory)~     identification deficits may reflect degeneration of cholinergic inputs to the olfactory bulb~     and other olfactory brain regions. Acetylcholinesterase inhibitors (ACheI) like donepezil~     show modest effects in improving cognition but can be associated with adverse effects and~     increased burden and costs because of the need for prolonged, often lifelong, treatment.~     Converging findings on odor identification test performance (UPSIT, scratch and sniff~     40-item test) from four pilot studies, including two of our own, suggest that acute change~     in the UPSIT in response to an anticholinergic challenge (atropine nasal spray), incremental~     change over 8 weeks, and even the baseline UPSIT score by itself, may predict cognitive~     improvement with ACheI treatment in MCI and AD. If change in odor identification deficits~     can help to identify which patients should receive ACheI treatment, this simple inexpensive~     approach will advance the goal of improving personalized treatment, improve selection and~     monitoring of patients for ACheI treatment, reduce needless ACheI exposure with risk of side~     effects, and decrease health care costs.~   "
84518|NCT01951105|"~     This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in~     individuals with sub-acute back pain (SBP) is associated with changes in blocking transition~     to chronic back pain (CBP).~   "
84519|NCT01951092|"~     Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of~     HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected~     individuals inconsistently engaged with care are less likely to receive ART which is~     associated with correspondingly adverse clinical outcomes in the long term and increased~     risk of transmission. Mobile health (mHealth) strategies including cell phone and text~     messaging have shown success in the developing world for medication adherence, yet mHealth~     interventions have not been developed to improve retention in HIV care. This strategy needs~     to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in~     supporting HIV treatment adherence in Rhode Island.~      The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive~     primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic~     in Rhode Island with patients also referred from eastern Connecticut and southern~     Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed~     within 1 year of entering care. In this environment, we propose a pilot study with the~     following specific aims:~      Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk~     of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in~     HIV care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the~     Immunology Center at TMH will be recruited to participate in a bidirectional mHealth~     intervention that delivers automated, regularly scheduled appointment and medication~     adherence reminders in an individualized format, and also allows individuals to request~     motivational enhancement and problem-solving support to address barriers to care.~      Specific Aim 2: To assess the impact and acceptability of the pilot intervention through~     qualitative interviews. All participants will also be invited to complete individual~     in-depth interviews which will assess acceptability and effectiveness of the pilot mHealth~     intervention, such as content and frequency of automatic messages, for retention and~     medication adherence for HIV-infected individuals in RI.~      The results of this study will provide preliminary data to inform an R21 or R34 application~     to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for~     loss to follow-up.~   "
84520|NCT01951079|"~     In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac~     Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in~     doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this~     study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up~     to 30 weeks pregnancy .~   "
84521|NCT01951066|"~     To measure various pro-permeability factors in the aqueous humor of patients with~     persistent/recurrent diabetic macular edema~   "
84522|NCT01951053|"~     The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement~     sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the~     study medication) of JNJ-40411813.~   "
84523|NCT01951040|"~     This study was designed as a retrospective cohort study where patients given synthetic~     oxytocin during labor induction were considered as the exposed cohort, and patients not~     given oxytocin formed the non-exposed cohort. Four hundred of the 7465 children born at our~     maternity during 2006 were randomly selected. Information about breast-feeding was available~     for 316 of these children. Eventual confounding or adjustment factors were analyzed using~     stratified and multivariate analysis (logistic regression~   "
84524|NCT01951027|"~     pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in~     healthy male subjects.~   "
84525|NCT01951014|"~     Currently little is known about the health beliefs and behaviors of pregnant adolescents.~     The goal of this pilot study is to educate pregnant adolescents via social media about~     nutrition and fitness during pregnancy and to evaluate their health beliefs and behaviors~     before and after receiving this information. Data collected will provide new information on~     which to base subsequent research and can be used to inform nutritional guidelines or public~     health programming for this vulnerable age group.~   "
84526|NCT01951001|"~     The purpose of this study is to determine whether the fixed-dose (prasugrel 10 mg/d vs. 5~     mg/d) vs. phenotype (platlet function test by VerifyNow P2Y12 assay)-based prasugrel dose~     adjustment can match therapeutic zone of platelet reactivity in PCI-treated Asians with~     acute coronary syndrome~   "
84527|NCT01950988|"~     The aim is to determine the efficacy and the satisfaction/adaptability of the manual~     Broscyl® toothbrush as compared with a standard  soft  manual toothbrush ADA (American~     Dental Association) reference using the modified Stillman brushing technique, in children,~     adults and elderly persons, after 3 months of daily use.~   "
84528|NCT01950975|"~     The principal result expected is the discovery of inframicroscopic chromosomal~     rearrangements in regions of the genome not yet known to be involved, or mutations in known~     candidate genes;~      The identification of such a mosaic rearrangement in an affected infant would lead to~     improved genetic counselling. Indeed, as this mosaicism is a consequence of a genetic event~     occurring at an early stage of embryogenesis, it would be possible to confirm the sporadic~     nature of the observed disorder and therefore to predict a very low or even negligible risk~     of recurrence for the couple concerned. For the affected infant, the risk for his/her own~     offspring will be assessed according to the nature of the genetic anomaly discovered. For~     medical practice, investigators hope that this study will lead to a clearer definition of~     the screening modalities for mosaicism in the disorders concerned. In particular, they hope~     to determine whether or not it is possible to dispense with a skin biopsy, which is more~     invasive than a blood sample.~   "
84529|NCT01950962|"~     This is a transversal double-centre study. Patients will be recruited from outpatient~     consultations. They will have buccal inflammation caused by periodontal disease (frequent~     oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding~     to slight, moderate and severe periodontal disease, will be formed according to the results~     of radiological and clinical examinations.~   "
84530|NCT01950949|"~     Mesquida, J et al showed there was a significant linear correlation between pulse pressure~     variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase~     of severe sepsis and septic shock. No study revealed the actual relationship between various~     PPV under different VT. So we hypothesized that there were relationship between various PPV~     in different tidal volume settings. The objective of this study was to examine the~     relationship between various PPV.~   "
84531|NCT01950936|"~     Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease,~      COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected~     acute exacerbation of COPD + / - pneumonia.~      Background: Patients with COPD exacerbation often get antibiotics. There is considerable~     criticism of this, many of these patients are not bacterially infected and the antibiotics~     overconsumption can lead to resistance development and side effects.~      The purpose: To show that one can reduce the consumption of antibiotics among patients~     hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving~     antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A~     sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current~     gold standard in measuring procalcitonin, Kryptor/ BRAHMS.~      Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the~     Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of~     age and there must be a signed informed consent.~      Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s~     danish personal identification number, not last digit (gender-fixed) (CPR-number). Even =~     procalcitonin-guided, Uneven = Control.~      2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission~     and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days~     after inclusion. Create a biobank in the study consisting of blood à 8 ml up to a maximum of~     4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS ®. Biobank~     destroyed 15 years after the completed project.~      Statistical considerations:~        1. Sample size / Sample Size:~           A total of 120 patients (please see the basis for this estimate of the Protocol).~        2. Analyze:~      A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2)~     broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C)~     Hospitalization within 28 days after the first hospitalization the year - the two groups~     between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics~     program SAS v. 9.1.3 is used.~      Economics: The study funded by the participating departments.~      Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department~     and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical~     Microbiology, Hvidovre Hospital.~      Science Ethics: There has been a thorough research ethics discussion of the project in the~     project with emphasis on an assessment of the advantages and disadvantages that might be for~     the participating patients and society as a whole now and in the future. Conclusions A and B~     of this discussion is summarized as:~      A. Advantages and Disadvantages: The treating physician has at any time the opportunity to~     start / continue antibiotic behandlling for the overall assessment whether PCT value. In~     addition, in the past, in large studies with a total of> 2000 patients, demonstrated that~     there are drawbacks to the use of antibiotics depending on a displayed value of PCT in~     patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will~     be monitored in this study. However, there may occur side effects to blood sampling, usually~     transient ecchymosis blood sampling site. If the strategy results in a reduced consumption~     of antibiotics, it is expected that the incidence of antibiotic-associated adverse events~     decreased - this for the benefit of the patient.~      B. Usefulness for society: Based on the results from this study will be a high degree of~     certainty to conclude whether this new treatment strategy can provide benefits for future~     patients in the form of reduced antibiotic consumption, less antibiotic associated adverse~     events, reduced resistance development / selection among bacteria and overall lower economic~     costs. Based on these considerations, believes the project, the project can be carried out~     with respect for the participating subjects to integrity.~      Quantity: It is expected to be included 120 patients in this scientific study. Database:~     data (case report forms) stored in archive of Pulmonary Medicine Department for 15 years.~     Create a database with the information. Personally identifiable data will only be present in~     the clinical hospital. During the completion of the experiment can provide essential health~     information about the subject's state of health. This will the subject be informed, unless~     clearly opted out of this on the consent form. The project reported to the Data Protection~     Agency.~      Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group~     (the active group), this part of routine blood sampling. At discharge stops blood and the~     patient should not attend the blood after discharge.~   "
84532|NCT01950923|"~     This randomized pilot clinical trial studies sildenafil citrate before surgery in improving~     kidney function in patients with kidney cancer. Sildenafil citrate may help protect the~     kidney from the side effects of surgery and improve kidney function after surgery.~   "
84533|NCT01950910|"~     Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive~     degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early~     diagnostic test for ALS, making identification of the disease difficult at its earliest~     stages. Early detection is critical to the initiation of early neuroprotective therapy. By~     the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle~     has already occurred. The purpose of the current project is to establish a bank of blood~     samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of~     an early diagnostic test for ALS and for better understanding the progression of this~     disease. The main idea of the current study is to examine samples from patients that have a~     suspected diagnosis of motor neuron disease, including patients with ALS who have not~     progressed far enough to be definitively diagnosed as having ALS. Normal and disease control~     samples will be collected for comparison. The investigators will examine various biochemical~     and metabolic markers from these samples, in hopes of finding differences in their~     expression between control subjects and ALS patients and during disease progression.~     Ultimately, the investigators would like to have a panel of markers from the blood that~     would allow us to diagnose and follow the progression of ALS from the earliest possible~     moment. The data collected from this project would give us a basis for a fairly~     non-invasive, quick and clinically relevant test for the early diagnosis of ALS. This in~     turn would allow us to provide earlier intervention for these patients, possibly slowing the~     damage and improving prognosis.~   "
84534|NCT01950897|"~     Muscular dystrophies are caused by mutations in more than 30 genes, some of them remaining~     to be identified. Phenotypically, it is known that one specific mutation can affect the~     expression of several other proteins, causing difficulty in diagnosis. Correct genotyping is~     essential for diagnosis, prognosis and treatment, and relies on a complexed analysis of~     muscle tissues for phenotype profiles. Our research aims to understand how different gene~     mutations affect expression of other genes via muscle biopsy samples and establishment of~     phenotypic profiles for correct diagnosis of individual patients. Establishment of such~     information will be critical for understanding the progression of different muscular~     dystrophies and to devise new experimental therapies. The research will also provide vital~     clues for finding new genes involved in the disease process. Muscle samples may also be used~     to establish cell cultures for testing drugs and new therapies relevant to the treatment of~     the muscular dystrophies.~   "
89757|NCT01882465|"~     Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring~     pattern to the contact lens. The purpose of this investigation is to determine if corneal~     staining increase is dependent upon the lens pigment location.~   "
84535|NCT01950884|"~     -  NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver~          disease in Western countries (hepatic manifestation of insulin resistance);~        -  NAFLD represents a cardiovascular risk factor;~        -  Lifestyle modification(weight loss)is the effective medical treatment recommended for~          NASH (Non-alcoholic Steatohepatitis);~        -  Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the~          investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive~          effect of ezetimibe on liver histology, biochemical and sonographic parameters in a~          small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs~          lifestyle+ezetimibe.~   "
84536|NCT01950871|"~     The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS)~     analysis can be used to improve the detection of clinically significant prostate cancer~     (PCa), and potentially reduce the burden and number of biopsies in routine clinical~     practice. Prostate HS is an ultrasound-based tissue characterization technology specifically~     developed to detect, visualize, and locate tissue suspected of harboring PCa. These~     suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy~     guidance tool has been developed that uses the results of the prostate HS analysis.~      The subjects that will participate in this study are all scheduled for a first biopsy of the~     prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data~     for prostate HS analysis. The results of HS analysis will be used later in the procedure.~     Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS.~     This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis~     and new biopsy guidance tool.~   "
84537|NCT01950858|"~     safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous~     osteonecrosis of the knee~   "
84538|NCT01950845|"~     Dynamic parameters like pulse pressure variation have been shown to be accurate predictors~     of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke~     volume optimization have been shown to improve patient outcomes, especially for moderate and~     high risk abdominal surgical patients. A novel closed-loop fluid administration system based~     on multi-parameter hemodynamic monitoring have been described recently. This prospective,~     randomized, surgeon and patient blinded study aims at comparing the cardiac output provided~     by either this closed-loop system or the anesthesiologist team in high-rish surgical patient~     elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon,~     France. Primary endpoint is the mean indexed cardiac output during surgery per group. We~     will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart~     rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of~     stay) between groups~   "
84539|NCT01950832|"~     To evaluate the macular, retinal nerve fiber layer (RNFL) and choroidal thickness~     alterations by using spectral-domain optical coherence tomography (SD-OCT) in polycystic~     ovary syndrome (PCOS) and to compare them with healthy reproductive-age women controls.~   "
84540|NCT01950819|"~     This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft~     function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal~     transplant recipients.~   "
84541|NCT01950806|"~     The objective of this randomized, controlled feeding study is to investigate the potential~     health benefits of a pecan-containing diet. The investigators hypothesize the chronic~     consumption of pecans will improve an array of biomarkers related to cardiovascular disease~     and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity,~     inflammation, endothelial function, and insulin resistance when compared with a control diet~     that is absent nuts.~   "
84542|NCT01950793|"~     The study is to compare the effect between steroid injection and Hyaluronic acid in~     treatment trigger finger. Using sonoguided injection technique achieves more accurate~     injection location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant~     and anti-inflammation effect in treatment of trigger finger, and can provide better outcome~     and lower adverse effect than steroid injection.~   "
84543|NCT01950780|"~     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune~     disease. In the disease, the immune system mistakenly destroys the hair follicle, causing~     hair to fall out. Despite many people having this disease, research into its cause and into~     new, better ways to treat AA has lagged far behind other similar diseases of the immune~     system. Currently, there are no Federal Drug Administration approved drugs for AA.~      Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the~     bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid~     arthritis, another autoimmune disease, by fighting inflammation. There are some genetic~     and chemical similarities between those with myelofibrosis, active rheumatoid arthritis and~     AA, suggesting that treatment with ruxolitinib may be effective in AA. In mice specially~     designed for testing drugs for the treatment of human alopecia areata, this medication~     worked to prevent the disease AA from starting in mice that would have otherwise developed~     the disease. To test Ruxolitinib, we are going to treat 12 patients with moderate to severe~     AA for a minimum of 3 months up to 6 months. This is an open-label study, meaning that~     there will not be a placebo group; all patients enrolled in the study will receive the~     active medication. The effectiveness of the medication will be measured by changes in hair~     re-growth as determined by physical exam and photography, as well as by patient and~     physician scoring. Patients will be followed for another 3 months off of the drug to see if~     the effects of treatment last and if there is delayed response. The safety of the~     medication, ruxolitinib, in patients with alopecia areata will also be evaluated.~      Blood work will be collected before medication is started, during the treatment period, and~     after ruxolitinib is stopped, in order to monitor for adverse effects of the medication.~     Small scalp biopsies and peripheral blood will be taken at the beginning of the study before~     treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at~     additional time points based on clinical considerations. The chemical analysis of these skin~     samples and blood will help us to understand how the disease happens, how the treatment~     works, and may even guide us to better treatments in the future.~   "
84544|NCT01950754|"~     This study could contribute to understanding the aggravation of balance disorders and the~     increased risk of falling in depressive people. It could, among other things, shed light on~     the impact of treatments with antidepressants on balance in treated depressive patients.~     Finally, it could contribute to improving the sensory-motor management of patients with a~     depressive syndrome.~   "
84545|NCT01950741|"~     Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy~     (PCV) will be evaluated.~   "
84546|NCT01950728|"~     The objective of this study is to compare the hypoalgesic effects of TENS, Interferential~     current and Aussie current in pressure pain threshold and sensory discomfort in healthy~     subjects.~   "
84752|NCT01948050|"~     This is a pilot study designed to collect preliminary data on safety and efficacy of~     transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who~     developed neuropathic pain in the affected area after a surgical intervention, radiation~     therapy, or chemotherapy to treat the disease.~   "
84547|NCT01950715|"~     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with~     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood~     but recent studies have shown changes in both colonic motility and rectal sensibility. The~     investigators have previously shown IBS patients to benefit from sacral nerves stimulation.~     With the present study, the investigators aim to evaluate if sacral nerve stimulation alters~     the gastro-colic response in IBS patients.~   "
84548|NCT01950702|"~     To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.~   "
84549|NCT01950689|"~     The purpose of this study is to see whether adding Nimorazole to standard radiotherapy~     benefits patients with locally advanced head and neck squamous cell carcinoma.~   "
84550|NCT01950676|"~     The primary aim of this study is to investigate the feasibility of using a patient-centered~     smart phone application for insulin self-titration on glycemic control. Over a 18-month~     period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents,~     thus requiring insulin treatment patients, will be recruited from the Singapore General~     Hospital (SGH). Patients randomized to the intervention group will be instructed to~     self-adjust their insulin dose using a smart phone application designed to guide~     self-titration; patients randomized to the control group will receive the usual clinical~     care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months~     post-enrollment. The investigators hypothesize that using a smart phone application for~     insulin self-titration is effective in improving glycemic control in T2DM patients compared~     with usual care.~   "
84551|NCT01950663|"~     RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy.~     The purpose of this study is to calibrate RETeval, and then measure its ability to detect~     vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS)~     7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol,~     will be used as the gold standard.~   "
84552|NCT01950650|"~     This study is conducted in Asia, Europe and in the United States of America. The aim of this~     study is to examine patient and physician beliefs regarding insulin therapy and the degree~     to which patients adhere to their insulin regimens.~   "
84553|NCT01950637|"~     This study is conducted Asia, Europe and North America. The aim of this study is to describe~     insulin therapy adherence and the burden of non-adherence on patient functioning, well-being~     and diabetes management.~   "
84554|NCT01950624|"~     Objective: The development of a patient registry for Down syndrome (DS) was identified as a~     priority in the 2007 Down Syndrome Research Plan. Under the auspices of the Down Syndrome~     Consortium, founded in 2011 as a public-private partnership between the NIH and DS advocacy~     organizations, NICHD awarded a contract in 2012 to create a patient-focused online registry~     to facilitate research participation by individuals with DS. Two advisory boards, composed~     of advocates, family members, clinicians, researchers, and other relevant parties, have been~     involved in the development of the registry materials.~      Study Population: Individuals with DS (including those with mosaic DS and partial trisomy~     21)~      Design: DS-Connect (TM) is an online survey tool designed to collect demographic data and~     health information from individuals with DS.~      Outcome measures: The purposes of DS-Connect (TM) are:~        1. To identify the various phenotypic manifestations of DS.~        2. To identify individuals with DS who may be eligible for research studies or new~          clinical trials, based on specific information about their diagnosis and health~          history.~   "
84555|NCT01950611|"~     The clinical outcome of relapsed acute promyelocytic leukemia (APL) is poor with current~     standard of care approaches. Additionally, standard of care warrants an autologous stem cell~     transplant to be done once molecular remission is achieved. Unfortunately, the majority of~     our patients cannot afford this procedure. We have previously reported the clinical outcome~     of relapsed patients who were managed without a stem cell transplants and showed that the~     event free survival at 5 years is less than 35%. Pre-clinical data reported from our~     laboratory demonstrates that there is significant synergy between arsenic trioxide (ATO;~     which is the accepted standard of care agent for relapsed APL) and Bortezomib (a proteasome~     inhibitor). We have evaluated this combination extensively in-vitro and this data was~     accepted as an oral presentation at the American Society of Hematology (ASH) meeting in~     2011. More recently we have also reported the potential mechanism for this synergy (Poster~     at ASH 2012). We also have mouse model data which supports these findings. We plan to move~     this combination of ATO based therapy combined with Bortezomib to a Phase II clinical trial~     to validate these observations. The anticipated potential is that we will have a combination~     therapy that is less expensive, cost effective and safe with comparable clinical outcomes to~     those treated with the more expensive standard of care which includes an autologous stem~     cell transplant and which the majority of our patients cannot afford.~   "
84556|NCT01950598|"~     The purpose of this study is to determine whether frozen corneas are as safe and effective~     as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over~     long term follow-up.~      Corneal transplantation is typically performed using fresh, transparent corneas. With KPro~     surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The~     cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen~     corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not~     transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent~     as fresh grafts when used as carrier for the KPro.~   "
84584|NCT01950234|"~     This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to~     evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar~     gel) administered as a pulsed regimen consisting of injections on three consecutive days per~     month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be~     randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1)~     pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of~     clinical and paraclinical measures of MS progression compared to placebo.~   "
84612|NCT01949870|"~     The objective of this study is to investigate the safety and tolerability of oral dose of~     selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese~     patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK)~     profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated~     dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will~     be identified, if possible.~   "
84557|NCT01950585|"~     Pulmonary arterial hypertension (PAH) is a serious and eventually fatal disease damaging the~     lungs and the heart. It results from narrowing and eventual blockage of small blood vessels~     in the lung, due to abnormal proliferation of cells in the blood vessel (arterial). Patients~     with PAH suffer from fatigue, shortness of breath, low oxygen levels, blood clots and heart~     failure. No therapies reverse the disease process in the lung arteries, however there are~     three approved drugs that can temporarily dilate the vessels and improve symptoms. However,~     all three drugs have significant side effects and toxicities, they do not work effectively~     in many patients, survival remains on average only 2 to 3 years once symptoms begin, and~     none of these drugs prevent the underlying disease process in the small arteries of the~     lung.~      PAH is known to develop in patients with a pre-existing class of bone marrow diseases called~     myeloproliferative disorders (MPDs). We and others have recently shown that patients with~     PAH have bone marrow changes similar to those seen in patients with MPDs, even without other~     signs and symptoms of those bone marrow diseases such as anemia or high platelet and white~     blood cell counts. Compared to healthy volunteers, patients with PAH have a higher frequency~     of immature stem and progenitor cells able to produce blood cells and vascular wall cells in~     their bone marrow. They also have higher circulating numbers of these cells in the blood,~     and increased localization of these cells in the lung blood vessels. When immature bone~     marrow cells from PAH patients and normal volunteers were infused into mice, the mice~     receiving PAH marrow cells developed similar lung and heart problems to PAH patients,~     suggesting that the bone marrow problem is a primary cause of the lung problems, and that~     the increased numbers of immature bone marrow cells in the bone marrow and blood of PAH~     patients causes the lung blood vessel disease.~      The drug hydroxyurea is used to inhibit the abnormally high level of bone marrow cell~     proliferation in patients with MPDs. It has been shown to reduce the numbers of circulating~     immature bone marrow cells in patients with MPDs. Hydroxyurea has been available for almost~     fifty years, and has been used to treat patients with MPDs, sickle cell anemia, and~     congenital heart disease for very prolonged periods of time, up to twenty or more years in~     individual patients. It has an excellent long-term safety profile and few side effects and~     is generally well tolerated. It does not appear to result in an increased rate of leukemia~     even with many years of treatment.~      In the current protocol, we hypothesize that treating patients with PAH with hydroxyurea~     will decrease the level of circulating immature bone marrow cells and interrupt the abnormal~     narrowing and occlusion of lung arteries. We will treat patients with moderately severe~     primary (no known underlying cause) PAH with 6 months of hydroxyurea, carefully monitoring~     side effects and adjusting dosage as necessary, and measure the effect on circulating~     immature cells, lung blood vessel pressures, other blood markers of active PAH, and exercise~     tolerance.~   "
84558|NCT01950572|"~     Background:~        -  Malignant mesothelioma is a malignancy arising from the mesothelial cells of the~          pleura, peritoneum, pericardium, or tunica vaginalis.~        -  Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant~          pleural mesothelioma is the most common of these, comprising of 80% of the cases with~          an annual incidence of about 2,500 in the United States.~        -  The median survival from diagnosis of pleural mesothelioma is approximately 12 months.~          The majority of patients present with stage III or IV disease with 85-90% of patients~          considered unresectable at diagnosis.~        -  Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless,~          patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment~          options due in large part to the rarity of the disease.~      Objectives:~      -To allow sample acquisition for use in the study of mesothelioma.~      Eligibility:~        -  All patients age greater than or equal to 2 years with malignant mesothelioma~        -  Must be able and willing to provide informed consent if 18 or over; parent or guardian~          must be able and willing to provide consent for patients under the age of 18~      Design:~        -  Up to 1000 subjects will be enrolled.~        -  Patients will be followed to determine the course of disease and to record any~          treatment received for mesothelioma.~        -  Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for~          tissue banking.~        -  Studies which may be performed on banked material include genetic and genomic studies,~          establishment of cell cultures and immunologic studies.~   "
84559|NCT01950559|"~     Food allergy is on the rise within the pediatric population. Having a food allergy can cause~     medical, nutritional and psychological issues in those who suffer with it. Although making~     the appropriate diagnosis of food allergy is very important, properly diagnosing food~     allergy has been a challenge. Skin prick testing and food-specific IgE testing of the blood~     can give positive results that are false. Currently, Oral Food Challenges are the best way~     to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may~     not be readily available to suspected food allergy sufferers. This study is designed to~     examine the effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured~     by the company, ThermoFisher.~      Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food~     allergies. A part of the study is to allow the study Sponsor to use some of the blood sample~     collected from you to test if genetically-changed soy has more or less allergy producing~     factors. This is important to the Sponsor to test the safety of their genetically modified~     soy.~   "
84560|NCT01950546|"~     This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the~     growth of S. mutans present in dental plaque of children.~   "
84561|NCT01950533|"~     Food allergy is on the rise within the pediatric population. Having food allergy can cause~     medical, nutritional and psychological issues in those who suffer with it. Although making~     the appropriate diagnosis of food allergy is very important, properly diagnosing food~     allergy has been a challenge. Skin prick testing and food-specific IgE testing of the blood~     can give positive results that are false. Currently, Oral Food Challenges are the best way~     to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may~     not be readily available to suspected food allergy sufferers. This study is designed to~     examine the effectiveness of an allergy-detecting blood test called IMMULITE 2000~     manufactured by the study sponsor, Siemens.~   "
84562|NCT01950520|"~     Background:~      - Changes in how a person s body burns energy or calories can affect their weight over time.~     The lowest level of energy the body needs to function is called basal metabolic rate. In the~     cold, we burn extra energy, even before we start to shiver. This is called non-shivering~     thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers~     want to learn more about this type of energy burning and how it is regulated. They hope this~     will help treat obesity in the future.~      Objectives:~        -  Sub-study 1: to better understand how non-shivering thermogenesis works.~        -  Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.~        -  Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic~          receptor agonist, on brown fat activity.~      Eligibility:~      - Healthy, lean adult males ages 18 to 35.~      Design:~        -  Participants will be screened with medical history, physical exam, blood test, and EKG.~        -  For sub-studies 1 and 2:~             -  Participants will receive one X-ray scan.~             -  Each day, all participants will:~      <TAB>- Have height and weight measured, and have urine collected.~        -  Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and~          computer. They will wear small non-invasive devices to monitor activity, heart rate,~          temperature, and shivering.~      <TAB>- Walk for 30 minutes.~      -For sub-study 3:~        -  Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs~        -  Each stay, all participants will:~      <TAB>- Have height and weight measured, and have urine collected.~        -  Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and~          computer. They will wear small non-invasive devices to monitor activity, heart rate,~          temperature, and shivering.~        -  Participants will be compensated for their time and participation at the end of the~          study~   "
84563|NCT01950507|"~     Background:~      The gastrointestinal (GI) tract is commonly affected by acute graft-versus-host disease~     (aGVHD) and chronic GVHD (cGVHD) in patients who have undergone blood or marrow stem cell~     transplantation (BMT). Initially, patients are treated with systemic corticosteroids, which~     produce complete response rates in 35 percent. Although short courses of steroids are~     preferred to minimize adverse effects, many patients require systemic treatment chronically~     since GI GVHD can negatively impact quality of life and nutrition status. One option to~     minimize systemic steroid exposure is by nonabsorbable corticosteroids that act locally on~     the GI tract.~      Budesonide (Entocort EC, AstraZeneca, Wilmington, DE) is an FDA-approved oral topical~     corticosteroid for the treatment of mild to moderate active Crohn s disease involving the~     ileum and/or the ascending colon, and for maintenance of clinical remission of mild to~     moderate Crohn s disease involving the ileum and/or the ascending colon for up to 3 months.~     It has a high ratio of topical-to-systemic activity with minimally active metabolites, and~     undergoes extensive first-pass metabolism. Since both intestinal GVHD and Crohn s disease~     seem to share a similar pathogenic background, budesonide has been used in the BMT setting~     for GI GVHD, usually in combination with systemic corticosteroids (e.g. methylprednisolone)~     to improve clinical response and allow for more rapid tapering of systemic corticosteroid~     doses.~      First-pass metabolism is mediated mostly by the cytochrome P450 (CYP450) enzyme system. The~     liver is the major site of CYP450-mediated metabolism but the enterocytes of the intestinal~     epithelium are also an important site for drug metabolism. Budesonide undergoes significant~     metabolism by CYP enzymes with substantial first-pass metabolism. The potential for greater~     systemic availability of orally administered budesonide exists when it is given concurrently~     with triazole antifungals, which are commonly prescribed for prophylaxis or treatment of~     fungal infections after transplantation. Fluconazole and voriconazole are moderate and~     strong inhibitors of CYP3A4, respectively, and budesonide is a CYP3A4 substrate. Inhibition~     of CYP3A4 may impair the metabolism of budesonide, resulting in systemic concentrations of~     budesonide and subsequently, adverse effects such as hyperglycemia. If the presence of~     fluconazole or voriconazole does impair budesonide s metabolism, then dose adjustments to~     budesonide may be warranted.~      There are no prospective studies evaluating the effects of fluconazole or voriconazole on~     budesonide s pharmacokinetics in patients who have undergone BMT.~      The primary objective of the proposed study is to determine the effects of fluconazole and~     voriconazole on the trough (Cmin) and peak (Cmax) of budesonide in patients who have~     undergone BMT and who have GI GVHD.~      The primary endpoints are the Cmin and Cmax of budesonide. Secondary endpoints include the~     Cmin of voriconazole.~      Objectives:~      The proposed study seeks to determine the effects of fluconazole and voriconazole on the~     Cminand Cmax of budesonide.~      Eligibility:~      Adult and pediatric subjects (greater than or equal to 13 years of age and greater than or~     equal to 49 kg) who are registered to an NCI or NHLBI protocol who have undergone a bone~     marrow, cord, haplo-cord or peripheral blood stem cell transplantation who have GI GVHD as~     determined by the medical team and who require treatment with budesonide and are candidates~     for antifungal therapy are eligible for this study.~      Design:~      Each subject will serve as his or her own control to minimize the variation in absorption,~     distribution, metabolism and elimination of oral budesonide that can occur from subject to~     subject, due to genetic, anatomic or other unidentified differences. For example, genetic~     polymorphisms of CYP2C19, which is significantly involved in voriconazole s metabolism,~     could otherwise affect the results of the study (i.e. CYP2C19 poor metabolizers may~     experience higher voriconazole serum concentrations, which could results in greater CYP3A4~     inhibition and higher budesonide exposure). In addition, the longitudinal cohort design of~     this study will be able to answer the research questions posed with fewer research subjects.~     Research subjects will be accrued into one of three cohorts depending on the antifungal~     prophylaxis (or lack thereof) the subject is receiving at study entry and the preference of~     the medical team for continued antifungal coverage after the initiation of budesonide and~     systemic corticosteroids. Subjects who are not currently receiving antifungal prophylaxis or~     who are on fluconazole at baseline are eligible for enrollment in Cohort 1. Subjects in~     Cohorts 2 and 3 are receiving voriconazole and fluconazole at study entry, respectively. In~     Cohort 1, if applicable, subjects will stop fluconazole on day -1...~   "
84613|NCT01949857|"~     The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune~     persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.~   "
84753|NCT01948037|"~     The purpose of the study is to investigate whether the hydrotherapy are effective in against~     pain and other symptoms in diabetes-induced LEAD.~   "
84564|NCT01950494|"~     Hand dermatitis, (a rash, or eczema, on the hands) is a common skin condition that affects~     approximately 10% of the population. It can be caused by a wide variety of things, such as~     allergens or irritants. For some, it can be painful and disfiguring. In moderate to severe~     cases, hand dermatitis can interfere greatly in the quality of life of the affected person,~     interfering with work and social functions. This can have a negative psychological effect as~     well.~      FiteBac Skin Care Gel is a new over-the-counter hand sanitizer that has been used for~     hospital and dental hand infection control. This product contains a germicide, to prevent~     infection. It also contains a silicone polymer. This makes the hand gel more durable,~     causing it to remain on the skin longer. Despite this durability, the hand gel still allows~     the skin to naturally perspire (sweat).~      As people in the health-care industry have used this new product with the goal of reducing~     hand infections, it has been noted that FiteBac Skin Care Gel also seems to have reduced~     hand dermatitis and improved personal skin condition. The purpose of this study is to~     scientifically measure skin improvement in a population of study subjects with hand~     dermatitis.~   "
84565|NCT01950481|"~     Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired~     hepatic function and healthy subjects with normal hepatic function.~   "
84566|NCT01950468|"~     This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the~     safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of~     parkinsonian syndromes from non-parkinsonian tremor.~   "
84567|NCT01950455|"~     This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess~     the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of~     parkinsonian syndromes from non-parkinsonian tremor.~   "
84568|NCT01950442|"~     Despite improvement in treatment-related morbidity and mortality, esophageal cancer is still~     one of the most lethal malignancies. Accurate staging is essential to establish prognosis~     and for patient management. Staging helps to determine if surgery, chemotherapy, radiation~     therapy, a combination of these, or a palliative approach is the most appropriate.~      Endoscopic ultrasound techniques are becoming more and more popular. At Notre Dame Hospital,~     Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal~     cancer undergo complete EUS staging. In selected patients, EUS is followed by EBUS during~     the same procedure, in order to examine all the lymph nodes near or far from the primary~     tumor amenable to EBUS guided trans-bronchial biopsy. In patients with a malignant~     esophageal stricture, we have preformed very gentle balloon dilation up to 14 mm. It is~     important to realize that this is not to achieve symptom resolution, but rather to allow the~     passage of the scope. We hypothesize that earlier reports of higher perforation rates were~     related to unnecessary aggressive dilation. Thus far, we have successfully dilated over 60~     patients during the last four years (2009-2013) and were able to pass the scope and complete~     the examination in the vast majority of patients with no morbidity.~   "
84569|NCT01950429|"~     Background:~      - Sickle cell disease changes the shape of red cells. This makes them more likely to break~     down as they get stuck in small blood vessels. This leads to low red cell count and also~     damage to small blood vessels that supply many organs. One of the affected organs is the~     liver. Sickle cell disease and its treatment through blood transfusion can lead to~     significant liver damage. This disease also can cause the liver to regrow abnormally after~     damage. This can cause high blood pressure in the liver. Researchers want to know if curing~     sickle cell disease with a stem cell transplant improves liver damage.~      Objectives:~      - To explore specific factors that improve or worsen sickle cell liver disease after a stem~     cell transplant.~      Eligibility:~      - Adults ages 18 and older with sickle cell liver disease.~      Design:~        -  Participation will take approximately 7 days over 2 years.~        -  Visit 1: participants will be screened with medical history and review of current~          treatment regimen.~        -  Visit 2: participants will return to the clinic for explanation of the study and~          physical exam. They will also have blood and urine tests, and scans of the liver.~        -  All participants will have a 2-night stay at the clinic. They will have a liver biopsy~          and a test of liver pressure. They will be sedated and a tube will be inserted in a~          vein in their neck.~        -  Participants who have a stem cell transplant will have a second biopsy about 24 months~          later.~        -  Over the 2-year study period, participants will have blood drawn 2-4 times and stool~          samples collected 2 times.~   "
84570|NCT01950416|"~     This is a two-center, prospective, randomized, single-blind, investigator initiated,~     pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers~     (Patras University Hospital and Konstantopoulio General Hospital of Athens).~      Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the~     previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission,~     pre coronary angiography, will be randomized after written informed consent, in a 1:1 ratio~     to either:~      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting~     12±6 hours post LD, until discharge.~      Or~      Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD)~     starting 12±6 hours post LD, until discharge.~      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24~     hours after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet~     reactivity units (PRU).~      Documentation of major adverse cardiac events (death, myocardial infarction, stroke,~     ischemia driven revascularization procedure with PCI or CABG) and bleeding (according to~     BARC criteria) will be performed until patient's discharge.~   "
84571|NCT01950403|"~     This randomized phase I trial studies the side effects and best dose of linaclotide acetate~     in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain~     drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal~     cancer.~   "
84572|NCT01950390|"~     This randomized phase II trial studies how well ipilimumab with or without bevacizumab works~     in treating patients with stage III-IV melanoma that cannot be removed by surgery.~     Monoclonal antibodies, such as ipilimumab and bevacizumab, block tumor growth in different~     ways by targeting certain cells.~   "
84663|NCT01949207|"~     The aim of this randomised case-controlled trial is to investigate whether ablation of~     incompetent perforating vein in addition to ablation of truncal vein reduces the rate of~     recurrent varicose veins post-treatment compared with patients who only have ablation of the~     truncal vein, who are left with untreated incompetent perforating veins.~   "
84573|NCT01950377|"~     Background:~      - Previous research has shown that dopamine, a brain chemical, is involved in decision~     making. Different genes influence how much dopamine people have in their brains and how that~     affects their behavior. Researchers will study if genes associated with dopamine affect~     decision making and impulsiveness. All participants will take tests; some will have brain~     images taken. Researchers will study the test responses and images; they will look for how~     differences in these genes affect different types of decision making.~      Objectives:~      - To see if genes involved in a brain chemical, dopamine, are related to impulsiveness on~     behavioral tests.~      Eligibility:~      - Healthy adults ages 18 to 55.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  All participants in this study will have at least 1 outpatient visit to the NIH~          Clinical Center. Each visit will last 2 4 hours. At the first visit:~        -  A blood sample will be taken only from participants that have not been previously~          enrolled in 95-M-0150~        -  Participants will be given tests of their memory, attention, concentration, and~          thinking.~        -  Some participants will have a second visit. It will be scheduled as soon as possible~          after the first. At the second visit:~        -  Participants will have an MRI (magnetic resonance imaging). They will have to lie in a~          scanner for up to 2 hours. The MRI uses magnets, radio waves, and computers to produce~          detailed pictures of the brain.~        -  Participants will repeat the tests from the first visit. Some will be done during the~          MRI.~   "
84574|NCT01950364|"~     This is an open-label trial to estimate the concentrations of brentuximab vedotin in~     relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large~     cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab~     vedotin + rifampicin.~   "
84575|NCT01950351|"~     The goal of this clinical research study is to learn if delivering proton therapy in higher~     doses per treatment may help control prostate cancer just as well as the standard of care~     treatment. The safety of this treatment will also be studied.~      Radiation dose is measured in units called Gray (Gy). The standard of care treatment~     schedule for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period~     of 8-9 weeks.~   "
84576|NCT01950338|"~     Stroke is the leading cause of physical disability, particularly due to the presence of~     spasticity. Different needling techniques, including the use of Botulinum Toxin A are~     proposed for the management of spasticity. The presence of spasticity in the lower extremity~     implies several impairments for standing and walking inducing high disability. No study has~     investigated the effects of deep dry needling inserted into the targeted spastic musculature~     in patients with stroke. The investigators will conduct a randomized controlled trial~     investigating the effects of a single session of deep dry needling over the musculature of~     the leg on spasticity, widespread pressure pain sensitivity and plantar pressures~     (baropodometry) in individuals with chronic stroke. The investigators hypothesize that~     patients receiving a single session of dry needling would exhibit a greater reduction in~     spasticity and pressure sensitivity than those who will not receive the intervention.~   "
84577|NCT01950325|"~     This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody.~     VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation~     study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is~     that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV)~     and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be~     collected to learn if VRC01 is detectable in mucosal secretions and blood of participants~     and how long VRC01 can be detected in the blood after it is given.~      Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose~     escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40~     mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include~     at least 3 participants. Each participant will receive two infusions of VRC01 with about 1~     month between doses. Infusions are administered in an inpatient unit and an overnight stay~     at the NIH Clinical Center is required. No more than one subject per day per group will~     receive a first infusion of the VRC01 product by the IV route and no more than one subject~     per week will receive a first infusion of the product by the SC route. Study participation~     lasts for 24 weeks. Participant health and effect on CD4 count and HIV viral load will be~     monitored. Samples will be collected and stored for research purposes.~   "
84578|NCT01950312|"~     The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy~     in patients with steroid resistant Autoimmune Inner Ear Disease.~   "
84579|NCT01950299|"~     VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra~     standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI)~     measuring the effects on the acute rise and fall of the plasma C reactive protein levels~     during the first 14 days.~   "
84580|NCT01950286|"~     Hyper-CVAD (a chemotherapy regimen) has shown promising results in adult T-cell Acute~     Lymphoblastic Leukemia (T-ALL). Patients with T-ALL diagnosis were reported to the Swedish~     Adult Acute Leukemia Registry between October 2002 and September 2006. Hyper-CVAD was~     recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation~     was recommended for patients with high-risk disease. The aim of this population-based study~     was to assess the efficacy of Hyper-CVAD treatment.~   "
84581|NCT01950273|"~     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of~     Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients~     with low tumor burden follicular lymphoma (LTBFL).~      The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and~     anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of~     anti-drug antibodies (ADAs).~   "
84582|NCT01950260|"~     The study will try to answer the question of whether early treatment with levothyroxine at 4~     weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low~     thyroid hormone levels).~   "
84583|NCT01950247|"~     The main objective of this study is to compare the safety, effect on quality of life, and~     resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the~     treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also~     assess the ability of baseline serum hepcidin levels to predict if subjects will have a~     clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.~   "
84585|NCT01950221|"~     This project is designed to study whether pomegranate extract benefits cognitive abilities~     in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one~     of two treatment groups: either a placebo or the pomegranate extract supplement. Both the~     placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain~     blindness. Subjects will take one 1000 milligram capsule daily for twelve months.~      The investigators expect the people receiving the pomegranate extract supplement to show~     better cognitive performance compared with those receiving a placebo after one, six, and~     twelve months. The investigators believe cognitive decline and treatment response will vary~     according to a genetic risk for Alzheimer's.~      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects~     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to~     rule out other neurodegenerative disorders linked to memory complaints.~      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.~     Following the first assessment, subjects will begin taking the supplement (either the~     pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month~     mark. At six months, subjects will have a second, full neuropsychological assessment. The~     final assessment will take place at the end of the study, the 12-month mark. Additional~     blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers~     if outcomes are positive. Subjects will also be asked to come to the University of~     California, Los Angeles (UCLA) at 3 and 9 months for supplement refills.~      In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13~     months.~   "
84586|NCT01950208|"~     the purpose of this study is to develop and validate a new PRO measurement tool for the knee~     joint, the so-called Munich Knee Questionnaire (MKQ), allowing for a qualitative~     self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS), the~     International Knee Documentation Committee (IKDC), the Lysholm Knee Score, the Western~     Ontario Meniscal Evaluation Tool (WOMET) and the Tegner Score.~   "
84587|NCT01950195|"~     This research is being done to look at the safety of using stereotactic radiosurgery (SRS)~     and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both~     Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of~     care uses both of these treatments but not together. By using them together, we expect~     better treatment of melanoma, but there might be an increase in side effects.~      Ipilimumab is approved by the Food and Drug Administration (FDA) for the treatment of~     melanoma that has spread throughout the body. It works by activating your immune system to~     fight off cancer.~      Stereotactic radiosurgery (SRS) is approved by the Food and Drug Administration (FDA) for~     the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without~     needing to cut or use stitches.~      The use of combining SRS and Ipilimumab in this research study is investigational. The word~     investigational means that this combination is not approved for marketing by the Food and~     Drug Administration but is allowed for use in this research study.~   "
84588|NCT01950182|"~     The primary objective of this study is to compare progression-free survival (PFS) of~     patients with metastatic Luminal B2 breast cancer subtype randomised to treatment with~     Trastuzumab Combined With Chemotherapy or Endocrine Therapy.~   "
84589|NCT01950169|"~     The study hypothesis is that nutritional supplementation together with bisphosphonates have~     a better preserving effect on bone mineral density (BMD) after hip fracture than~     bisphosphonates alone and that nutritional supplementation given postoperatively for 6~     months preserve lean body mass in elderly hip fracture patients.~   "
84590|NCT01950156|"~     The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,~     which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets~     for vaccination against lung cancer. In this clinical study, the investigators examine using~     a combination of these three peptides the safety, immunogenicity, and antitumor effect of~     vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced~     non-small cell lung cancer patients whose disease are controlled after any standard~     therapies.~   "
84591|NCT01950143|"~     The biology of prostate cancer is associated with changes in genes and metabolites within~     prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can~     prevent or retard the development of prostate cancer by influencing these changes. This is~     likely to be due to a natural chemical that is obtained in these vegetables known as~     sulforaphane.~      In this study, we are seeking to provide further evidence that a diet rich in broccoli may~     prevent prostate cancer from developing, and to understand how this may happen. We propose~     to undertake a human intervention study to test the hypothesis that a broccoli-rich diet can~     alter the metabolism and gene expression within prostate tissue of men under active~     surveillance in a manner that would reduce the probability of the emergence and progression~     of aggressive cancerous clones. Participants recruited onto this study will be randomly~     allocated to one of three dietary groups in which they will be required to consume one~     portion per week of a broccoli soup delivering a different concentration of sulforaphane.~     This will be part of their normal diet for one year.~      Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month~     intervention period. Prostate biopsies will be obtained either though transperineal template~     biopsies, a technique accepted as best clinical practice because it provides better sampling~     of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of~     care for obtaining biopsies.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
84610|NCT01949896|"~     Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping~     feeds or continuing feeds. The intervention group will be the placement of a subject in the~     NPO group. Subjects in the intervention group will have their feedings stopped for a total~     of 24 hours around the time of the PRBC transfusion. These infants will be given intravenous~     nutrition during the period of time that they will not be fed. During the transfusion, both~     groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours~     pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.~   "
84611|NCT01949883|"~     First in human, open-label, sequential dose escalation and expansion study of CPI-0610 in~     patients with progressive lymphoma. CPI-0610 is a small molecule inhibitor of bromodomain~     and extra-terminal (BET) proteins.~   "
84592|NCT01950130|"~     Due to advances and increased practice of interventional therapy for coronary artery~     disease, the rate of high-risk patients with severe coronary disease and reduced left~     ventricular function among patients undergoing coronary artery bypass grafting surgery~     (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The~     perioperative and operative management for these patients has to be optimized in order to~     reduce their perioperative morbidity and mortality. One of the central aspects is~     perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly~     established, but not sufficiently evidence-based measure to reduce ventricular afterload and~     improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive~     procedure with potential complications. The planned trial should give an explicit answer,~     whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary~     endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to~     preoperative conservative treatment in high-risk patients undergoing CABG.~   "
84593|NCT01950117|"~     Recently, it was reported that the incomplete resection rate of neoplastic large polyps~     after conventional polypectomy was markedly high in clinical practice. The incomplete~     resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not~     known.~      The aim of this study is to compare the incomplete resection rate of neoplastic large polyps~     after EMR or conventional polypectomy. The EMR technique is preferable to conventional~     polypectomy for the complete resection of the large polyps (>15 mm in diameter)~   "
84594|NCT01950104|"~     Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results~     of assisted reproduction techniques through the selection of embryos free of chromosomal~     abnormalities.~      At present, it has not been proved that the usage of PGS really improves the live birth rate~     in IVF cycles. However, it has been stated that the reason of not having better results when~     using PGS is that the methodology applied is not adequate.~      Several authors propose that the optimal methodology for PGS includes the application of~     comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo~     biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3~     embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards~     the usage of blastocyst-stage biopsy instead of day 3 biopsy.~      The purpose of this clinical study is analysing the results of the IVF cycles with embryo~     biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation~     rates together with embryo quality will be analysed and compared between two groups of~     patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of~     the embryo development, while in the other group the embryo biopsy will be fulfilled at the~     blastocyst stage.~   "
84595|NCT01950091|"~     Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no~     underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician~     care. Treatment, however, is impractical for many physicians to implement during office~     visits, and there are relatively few providers for NLBP treatment that follow national pain~     control guidelines. This study evaluated the efficacy of an on-line intervention using~     desktop computers or mobile technology to help users self treat NLBP occurrences and to~     engage in activities to decrease future occurences.~   "
84596|NCT01950078|"~     Objective: This study was conducted to explore the possible correlation between some gene~     related to pain sensation and individual basal pain perception and postoperative pain~     intensity in the general population. Methods: Patients receiving elective surgery under~     general anesthesia were recruited into this study. The investigators measured their~     preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity~     at rest and movement after the operation was evaluated . And the PCA drug consumption were~     recorded. Also there were healthy college students volunteer be recruited into this study.~     The investigators measured their experimental pain sensitivity including pressure pain~     threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.~   "
84597|NCT01950065|"~     Evaluate the effectiveness and safety of the iovera device for the temporary reduction in~     the appearance of forehead wrinkles.~   "
84598|NCT01950052|"~     This study is a randomised control trial comparing the effects of a pre-operative very low~     calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric~     surgery.~      The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some~     centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of~     shrinking the liver to make surgery easier. Studies have shown that after this diet the~     liver does shrink and therefore operating may be easier but this did not necessary translate~     into significant lesser operative times. The effects of operating during a catabolic phase~     have not been evaluated. Theoretically a low calorie diet before surgery is similar to~     starving a patient and can potentially create a state of malnutrition. This is rarely~     advisable before surgery and can lead to poor wound healing and poor healing of bowel~     anastomosis.~      This study will ascertain if there is any difference in wound healing rates in these~     morbidly obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in~     groups who have taken the preoperative diet compared to those who were not on a special~     diet. Skin wounds will be evaluated. This will potentially reflect the general state of~     healing of the patient which includes the healing of bowel anastomosis. Surrogate markers~     will be employed to evaluate the pre-morbid nutritional state, effectiveness of dieting,~     subsequent wound healing (collagen production, markers for the different aspects of wound~     healing) and impact on liver cell death .This study will be able to tell us how safe this~     calorie deficient diet is in these morbidly obese patients before surgery.~   "
84599|NCT01950039|"~     Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine~     levels to diabetes and cardiovascular disease. Small human studies suggest benefit for~     non-alcoholic liver disease. In this study we will determine if administration of betaine~     improves metabolic measures, liver fat and/or endothelial function in humans with glucose~     intolerance who are overweight.~   "
84600|NCT01950026|"~     The aim of this study was to reheat the skin in different ethnic groups after application of~     cryotherapy.~   "
84601|NCT01950013|"~     The purpose of this study is to investigate the effectiveness of an auditory training~     program used at home with the subject's own hearing aids.~   "
84602|NCT01950000|"~     Background: Few studies have addressed the situation of procedural pain and the use of~     preemptive analgesia for turning in patients under mechanical ventilation.~      Aim: Evaluation effect of preemptive fentanyl on the incidence of pain during turning~     maneuvers in critically ill patients under mechanical ventilation.~      Design: Single-center clinical trial, national, randomized, double-blind, with a parallel~     group, and two arms of treatment: saline placebo and fentanyl.~      Primary Endpoint: Incidence of pain during the turning procedures that are carried out by~     nurses measured by means of the Behavioral Pain Scale (BPS).~      Study Population: Critically ill patients, age > 18 years, admitted to ICU and expected to~     require mechanical ventilation for at least 24 h.~      Sample Size: 80 patients divided into the two groups (40 patients each). Statistical~     Analysis: A preliminary descriptive analysis will be carried. Later, results of primary end~     point will be comparing after the eventual corrections of corresponding variables using a~     multivariable approach. The AUC variable will be analyzed by a t-test for unpaired data. A~     second analysis using a multivariate approach will be carried out for those factors~     considered as clinically relevant in relation to pain and therefore a logistic regression~     will be used.~      Ethical Considerations: The study will be strictly conducted following the Declaration of~     Helsinki and the protocol and Standard Operating Procedures (SOPs) to ensure compliance with~     the Good Clinical Practice (GCP) standards. It is the responsibility of the researcher to~     obtain the valid informed consent from the guardian / legal representative, as the patient's~     condition will not allow to consent. Before obtaining the consent the investigator will~     explain to each guardian / legal representative the nature of the study, its purpose, the~     procedures, the estimated duration, the potential risks and benefits associated with the~     participation, as well as any inconvenience that this may involve.~      Duration of Treatment: The treatment has a maximum duration of 60 min for each patient. The~     follow-up includes visits and has duration of 6 consecutive days.~      Safety Assessment: Potential side effects of treatments will be recorded. Frequent adverse~     effects of fentanyl administration include respiratory depression, apnea, muscle rigidity,~     bradycardia and transient hypotension.~   "
84603|NCT01949987|"~     Pain score after inguinal hernia repair surgery in children decreased as time passed in~     previous studies. Postoperative oral intake is usually resumed two hours after minor surgery~     in most of institutions, that may influence children's behavior and pain score.~      A recent study suggest that oral intake one hour after minor surgery does not increase the~     incidence of postoperative nausea and vomiting.~      The investigators primary endpoint is to clarify whether postoperative oral intake~     influences postoperative pain score in children.~   "
84604|NCT01949974|"~     The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral~     Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in~     patients with advanced cancer who have already received at least a first course of~     chemotherapy but had proven therapeutic failure.~      The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to~     quality-of-life-adjusted survival compared to a comprehensive care program.~   "
84605|NCT01949961|"~     BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The~     overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with~     large clots may not achieve re-opening of the vessel and up to 40% of the patients may~     remain severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined~     with thrombolysis (sonothrombolysis) and increases the likelihood of functional independence~     at 3 months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances~     the thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced~     ultrasound may also accelerate clot break-up in the absence of thrombolytic drugs (contrast~     enhanced sonolysis = CES).~      HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after~     symptom onset may be given safely to patients with acute ischemic stroke, both to those~     receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and~     will improve clinical outcome.~      AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no~     ultrasound treatment in patients with acute ischemic stroke receiving or not receiving~     intravenous thrombolysis.~      STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of~     concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are~     bleeding complications (safety), brain damage (infarct size/location) and early clinical~     improvement (effect).~   "
84606|NCT01949948|"~     BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only~     approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase~     is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening~     of the vessel and up to 40% of the patients may remain severely disabled or die, leaving~     substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may~     be more effective and may have less bleeding complications than alteplase, and may be the~     drug of choice also in stroke.~      HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a~     dose that is associated with improved clinical outcome compared with existing treatment~     options.~      AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after~     symptom onset.~      STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months~     (effect). Secondary study endpoints are major early clinical improvement (effect) and~     bleeding complications (safety).~   "
84607|NCT01949935|"~     The hypothesis is that application of Mupirocin to the nose before and after coronary artery~     bypass grafting surgery will reduce the incidence of surgical site infections.~   "
84608|NCT01949922|"~     Aim:~      To investigate efficacy and safety in a new treatment with injection of autologous muscle~     fibers into the anal sphincter in patients with fecal incontinence.~      Method:~      Patients with fecal incontinence after obstetric anal sphincter rupture will be included.~     After inclusion, they will be offered 3 months of pelvic floor muscle training. If the~     patients after completion of pelvic floor muscle training still suffer from fecal~     incontinence, the patients will be offered treatment with autologous muscle fiber injection~     into the anal sphincter. The patients will be followed one year after the injection. The~     autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and~     injected into the anal sphincter. A small part of the fibers are used for analysing number~     of muscle stem cells and thereby the regenerative potential of the sample.~      The study is a pilot study.~   "
84609|NCT01949909|"~     P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and~     immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A~     antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European~     volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase~     Ib).~   "
84754|NCT01948024|"~     This is a Multiple-dose, steady state, three-way reference-replicated crossover study.~      The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine~     10mg sublingual tablets.~   "
84614|NCT01949844|"~     This is a pilot study in a patient population with suspected Coronary Artery Disease CAD) as~     defined by the presence of an abnormal nuclear (PET/SPECT) perfusion scan. In this study~     design, PET/SPECT will serve as the comparative standard for presence of myocardial~     ischemia. We intend to determine the accuracy of a novel MR technique for localization of~     perfusion deficits in comparison to PET/SPECT.~      This is not a study to specifically evaluate the efficacy or safety of the drugs but rather~     the diagnostic accuracy of the cardiac MRI procedure as a whole~   "
84615|NCT01949831|"~     The aim of this study is to examine the effect of systematic assessment of functional~     ability, development of rehabilitation plan and follow-up at home for elderly medical~     patient's risk of readmission. The effect of the intervention is examined in a randomized~     controlled trial.~   "
84616|NCT01949818|"~     The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule~     Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.~   "
84617|NCT01949805|"~     Phase III study to compare the efficacy and safety of the novel monopegylated interferon~     alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One~     year treatment of patients with polycythemia vera. Objective is to demonstrate~     non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and~     currently treated patients, diagnosed with Polycythemia Vera. Response is measured as~     normalisation of key lab parameters as well as normalized spleen size.~   "
84618|NCT01949792|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII)~     following one single injection of 270 microg/kg compared to three injections of 90 microg/kg~     rFVIIa in patients with haemophilia.~   "
84619|NCT01949779|"~     The primary objective of this registry is to collect real world data on the safety and~     performance of the TransForm™ Occlusion Balloon Catheter when used in current~     neurointerventional procedures~   "
84620|NCT01949766|"~     This is a single patient compassionate use protocol to determine whether RAVICTI will~     improve bile flow in a subject who previously tolerated therapy with Buphenyl.~   "
84621|NCT01949753|"~     Characterization of the influence of pregnenolone vs. placebo on subjective distress and~     autonomic functioning during cognitive-behavioral exposure therapy in patients with~     obsessive-compulsive disorder.~   "
84622|NCT01949740|"~     This pilot research trial studies patient preferences in making treatment decisions in~     patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient~     priorities before and after treatment may improve the ability to plan for better quality of~     life in patients with oropharyngeal cancer.~   "
84623|NCT01949727|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data have shown that COPD is associated with substantial~     cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization~     result in marked patient deterioration, and heightened CV risk. The cause of the increased~     CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease~     are unknown; however, it may be due to chronic inflammation which is exacerbated with a~     flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest~     during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few~     studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV~     risk. Disease management programs, such as pulmonary rehabilitation and patient~     self-management education, are part of guideline therapy for COPD; however, these are not~     regularly implemented following a hospitalization, and how these interventions affect~     patient outcomes, behavior, physical activity, inflammation and CV risk have not been well~     studied. The proposed long-term project will examine how typical inpatient COPD care, and~     how early referral to chronic disease management programs after hospital discharge, affect~     patient outcomes. This grant brings together an outstanding group of researchers who have~     the necessary clinical, content and methodological expertise to successfully complete this~     work. These studies will provide invaluable information about inpatient and outpatient~     management for a disease which has a tremendous impact on healthcare.~   "
84624|NCT01949714|"~     -  To investigate the effect of catecholamine excess on brown fat.~        -  To evaluate the effect of brown fat on energy expenditure and lipid and glucose~          metabolism~   "
84625|NCT01949701|"~     The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which~     was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung~     cancer. In this clinical study, the investigators examine using the peptides the safety,~     immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease~     for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are~     controlled after any standard therapies.~   "
84626|NCT01949688|"~     In this study, the investigators examine using a combination of two types of HLA-A*2402 (or~     HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the~     safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor~     patients who are refractory to standard therapy.~   "
84627|NCT01949675|"~     The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine~     (Shanchol™) in The Philippines~      Objectives:~        -  To describe the safety after each dose of Shanchol vaccine.~        -  To describe the immunogenicity after each dose of Shanchol vaccine.~   "
84628|NCT01949662|"~     The goal of this clinical research study is to learn if giving lorazepam in combination with~     haloperidol can help to control the symptoms of delirium in patients with advanced cancer.~     The safety of this drug combination will also be studied.~      In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to~     be compared with a study drug to learn if the study drug has any real effect.~   "
84755|NCT01948011|"~     To investigate the Racecadotril pharmacokinetic linearity after single oral administration~     of 10, 30 and 60 mg as a suspension.~      To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension)~     versus the reference sachet formulation (granules)~   "
84629|NCT01949649|"~     Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge~     eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise~     Specified (ED-NOS), which includes subthreshold variants of these disorders. Over half of~     those presenting for eating disorder treatment meet criteria for ED-NOS and both threshold~     cases and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and~     increased risk for future obesity, depression, suicide attempts, anxiety disorders,~     substance abuse, morbidity, and mortality. Anorexia and bulimia nervosa show stronger~     relations to suicide attempts, outpatient/inpatient treatment, and functional impairment~     than most other psychiatric disorders. Treatment of eating disorders is very expensive,~     similar to the cost for schizophrenia treatment, and is effective for only 40-60% of~     patients. Thus, a public health priority is to develop and disseminate effective eating~     disorder prevention programs.~   "
84630|NCT01949636|"~     The purpose of this study is to test the dynamic vulnerability model of obesity using brain~     imaging.~   "
84631|NCT01949623|"~     In this study, markers of oxidative stress will be measured in the aqueous humour and plasma~     of RP patients compared to controls.~   "
84632|NCT01949610|"~     The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of~     metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants~     after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.~   "
84633|NCT01949597|"~     The recurrence of endometriosis after surgery a formidable challenge for the gynecologist.~     Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50%~     at 5 years. Several theories attempt to explain these high figures. The three most widely~     accepted are:~        -  The presence of residual endometriotic tissue or residual endometriotic cells not~          completely eradicated during surgery~        -  The growth of undetected microscopic endometriosis during surgery~        -  The development of endometriotic lesions de novo Patients with symptomatic~          endometriosis diagnosed by ultrasound or MRI and suitable for surgery will participate~          in the study. The surgical specimens sent for pathology from bladder, vagina,~          uterosacral, sigma or rectum will be properly marked for studying the presence of~          endometriosis.~   "
84634|NCT01949584|"~     This is a prospective, interventional, study in which patients with a history of habitual~     snoring to determine whether low pressure nasal continuous airway pressure can reduce the~     frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do~     not have Obstructive Sleep Apnea (OSA).~   "
84635|NCT01949571|"~     INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the~     high rate of relapses occurs within the first months after detoxification. In the early~     withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as~     crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects~     of the substance, known as craving. Most of the times, these clinical symptoms act as~     negative reinforcement, which can be severe enough to induce a drug-relapse that greatly~     hampers the treatment.~      TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine~     the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1)~     To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence~     disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy~     of reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in~     subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the~     maintenance of abstinence in patients with cocaine dependence disorder treated with~     mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent~     on cocaine comorbid with major depressive disorder.~      HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction~     in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the~     neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect~     anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of~     the National Institute of Psychiatry who meet the inclusion criteria and invite them to~     participate voluntarily. If patients accept, send them to the principal investigator for the~     start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and~     Depression Scale Beck Scale.~   "
84636|NCT01949558|"~     Chronic diseases such as overweight and cardiovascular diseases represent important threats~     to women's health. Pregnancy and lactation are associated with changes in weight, body~     composition and lipid metabolism and affect the risk of developing these chronic illnesses.~     Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese~     women's ability to make longterm lifestyle changes during the postpartum (pp) period, under~     ideal study conditions. Physiological mechanisms for weight reduction were investigated with~     precise methodology. However, effectiveness studies under different conditions are crucial~     for the development of effective programs for the Primary Health Care sector. Hence, the~     interest for translational research that brings results from clinical trials to the Primary~     Health Care sector has increased. The aim of this effectiveness-study is to investigate if~     dietary restrictions pp lead to significantly greater weight reduction among~     overweight/obese women, compared to no intervention, in a longterm perspective. In total 106~     women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary~     restrictions in individualized intervention during 12 wks. One and two years pp long term~     effects are evaluated. Positive results may be integrated into usual practice after the~     study ends.~   "
84637|NCT01949545|"~     The purpose of this study is to compare the safety and efficacy of carfilzomib, including~     measuring the amount of the study drug in the blood at certain times following dosing. This~     study is being done in people with varying degrees of liver function to see if they respond~     differently to the study drug.~   "
84638|NCT01949532|"~     The purpose of this study is to see how the body and the cancer react to carfilzomib,~     including measuring the amount of the study drug in the blood at certain times following~     dosing. This study is being done in people with normal kidney function and those with~     end-stage renal disease to see if they respond differently to the study drug.~   "
84676|NCT01949038|"~     Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most~     of the patients. Various methods are available for sedation during this procedure. Because~     of some side effects related to intravenous administration of sedatives, oral administration~     of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in~     treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as~     for sedation during this procedure. We hypothesize that sublingual alprazolam is more~     effective than that oral form and both forms more effective than placebo in reducing anxiety~     and pain/discomfort related to the procedure.~   "
84756|NCT01947998|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Warfarin for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
84639|NCT01949519|"~     Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate~     cancer. While it has clinically useful activity, there is a strong need for substantial~     improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to~     combine it with an agent that either minimized toxicity (thus allowing higher doses) or~     improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for~     combination with docetaxel because of its known accumulation in prostate tissue, its low~     toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6~     levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate~     cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD)~     of lycopene given in combination with docetaxel. This dose can then be used for subsequent~     phase II or phase III studies.~      New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent~     chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly~     improved overall survival compared with delayed or no chemotherapy. These subjects could~     also benefit from intervention to increase docetaxel effectiveness.~   "
84640|NCT01949506|"~     This is a prospective study to document the local control rates with SBRT specifically for~     pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute~     and late toxicity, quality of life (QoL), tumor control, and survival.~   "
84641|NCT01949493|"~     The objective of this study is to evaluate the effectiveness of mechanical traction in~     patients with Carpal Tunnel Syndrome compared to care as usual.~   "
84642|NCT01949480|"~     The overall purpose of this research study is to compare the effectiveness of ultrasound~     assisted paravertebral block placement versus traditional blind technique for~     postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.~   "
84643|NCT01949467|"~     The diagnosis of iron overload is a common problem. It is important to optimize the~     diagnosis to ensure support for patients and their relatives especially regarding genetic~     disease.~      Iron overload revealed by a high level of serum ferritin and confirmed by the presence of an~     excessive amount of iron in the liver is a frequent situation. In a lot of case there is no~     increase in serum iron and transferrin saturation. This situation may arise in particular in~     patients with:~        -  a genetic iron overload related to mutation in the ferroportine gene, leading to a~          ferroportin disease. The diagnosis is based on the sequencing of the gene,~        -  a dysmetabolic hepatosiderosis, the most frequent situation , where iron overload is~          associated with abnormalities in the metabolism of carbohydrates and fats, whereas no~          genetic cause is identified.~      However, patients often have similar biological signs and despite the implementation of~     strict algorithm regarding the diagnostic procedure, it appears that a large number of~     patients are tested for the mutation in the ferroportin gene, and that mutation is not found~     in most cases. It is therefore essential to optimize the diagnosis process by introducing~     additional criteria.~      The investigators' hypothesis, based on the known elements, is that the response to a single~     dose of iron will modulate differently the iron parameters measured in serum, including~     hepcidin level which controls iron metabolism and metals associated with iron. This could be~     helpful for diagnosis procedure in patients with ferroportin disease or dysmetabolic~     hepatosiderosis.~   "
84644|NCT01949454|"~     The investigators aim to evaluate a new potentially cost-effective approach to improving~     trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The~     investigators hypothesize that adjunctive topical fluorometholone therapy following~     trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this~     hypothesis is that interruption of inflammation postoperatively would reduce postoperative~     scarring, leading to better outcomes. As an initial step toward evaluating this modality,~     the investigators believe it to be necessary to evaluate topical corticosteroid therapy in a~     safety-oriented study, for which the investigators also hypothesize that fluorometholone~     will have a perioperative safety profile acceptable for large-scale programmatic use.~     Topical corticosteroid therapy is associated with potential risks of cataract induction and~     intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower~     intraocular penetration than alternative corticosteroids, with correspondingly less~     IOP-raising effect while still having favorable effects on conjunctival inflammation, and is~     a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an~     advantage in this setting, as the major side effects of therapy are the result of~     intraocular effects, and therapy only is needed to the conjunctiva. However, prior to use in~     a large-scale trial it is sensible to make sure adverse outcomes are not observed in a~     substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial~     are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal~     dosing schedule and to identify any preliminary signals of potential efficacy.~   "
84645|NCT01949441|"~     House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated~     with poorer lung function, greater medication requirements and more asthma symptoms as well~     as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that~     HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in~     HDM-sensitised patients.~      ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide~     Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.~      This study to assess the tolerability of ToleroMune House Dust Mite in subjects with~     controlled asthma and house dust mite-induced rhinoconjunctivitis.~   "
84646|NCT01949428|"~     A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a~     History of House Dust Mite-Induced Rhinoconjunctivitis~   "
84647|NCT01949415|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated~     with poorer lung function, greater medication requirements and more asthma symptoms as well~     as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that~     HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in~     HDM-sensitised patients.~      ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.~      Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will~     identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002~     study participants~   "
84648|NCT01949402|"~     There is increasing interest in how thoracic (chest) ultrasound might enhance the management~     of patients with respiratory failure and breathlessness, particularly in the emergency~     admissions or intensive care setting. Thoracic ultrasound is already used in a number of~     clinical settings. It is recognised that a number of lung abnormalities can be identified~     using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue~     lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive~     diagnostic tool that provides immediate feedback and results.~      Patients with breathlessness and respiratory failure represent a significant proportion of~     emergency admissions to hospital and commonly require urgent treatment with limited~     information available to guide the clinician. The range of diseases that present with~     breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and~     difficult to differentiate in patients who often have multiple medical problems. This leads~     to non-specific treatment in the face of diagnostic uncertainty with the associated risks of~     treatment complications, increased morbidity and mortality, and distress for patients and~     relatives. It is in the assessment of these patients with acute respiratory failure where~     thoracic ultrasound might be of greatest benefit and which this research is designed to~     address.~      This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over~     an eight month period. The study will test the reliability of a thoracic ultrasound protocol~     at identifying lung abnormalities in a stable outpatient population with respiratory disease~     (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis~     to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study~     will inform further research in acutely unwell patients with respiratory failure and~     breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic~     decisions.~   "
84649|NCT01949389|"~     The purposes of this study is to examine the feasibility of implementing an internet-based~     treatment for insomnia among veterans with substance use disorders, some with co-morbid~     serious mental illness, and to develop potential methods to support and encourage veterans~     while they self-administer this treatment. Our hypotheses are that the implementation of an~     internet-based therapy will be feasible and that a method of support can be devised, and~     tested in the future.~   "
84650|NCT01949376|"~     The purpose of this study is to improve our understanding of potential changes in size,~     shape and activity in some brain areas that can occur in women receiving different types of~     Breast Cancer therapy, and how these changes are related to the development of mild~     cognitive impairment as the result of these treatments.~   "
84651|NCT01949363|"~     This study is a Phase I, open label, non-randomized, dose-frequency escalation~     pharmacokinetics study among 24 healthy male and female subjects, aged 18 to 45 years to~     determine the pharmacokinetics and safety of high-, multi-dose cefixime for the treatment of~     reduced susceptibility gonorrhea. Stage 1(Cohorts A and B) will examine the pharmacokinetics~     of single 400mg and 800mg dose of cefixime. Stage 2(Cohorts C and D) subjects will take~     800mg of cefixime every 12 hours for 2 doses. If that dosing regimen is well tolerated, the~     dose-frequency will escalate to 800mg every 8 hours for 3 doses, and serum levels of~     cefixime will be measured. Study duration is approximately 47 weeks.~   "
84652|NCT01949350|"~     Major non-cardiac surgery has a high degree of morbidity and mortality. Recently,~     measurement of a patient's preoperative cardiorespiratory reserve, performed non-invasively~     by cardiopulmonary exercise testing, has been shown to be predictive of outcome following~     non-cardiac surgery. All patients prior to major surgery are starved for a minimum of 6~     hours and often longer prior to major elective surgery. It has been shown that elite~     athletes who are hypohydrated have reduced exercise capacity and lower cardiorespiratory~     function. These results are further exaggerated in non-trained individuals. Therefore, the~     starvation policy prior to surgery may have a deleterious effect on outcome after surgery.~      4.2 AIMS This is a pilot study of health volunteers to assess the role of carbohydrate (CHO)~     (preload) and carbohydrate-protein (CHO-P) (Highfive energy source 1 in 4) in improving~     aerobic capacity after a period of fasting mimicking the current starvation policy prior to~     surgery. Both of these have similar calorific value and only differ in the amount of~     carbohydrate and protein supplementation.~   "
84653|NCT01949337|"~     This randomized phase III trial studies enzalutamide to see how well it works compared to~     enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant~     metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs,~     such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of~     androgens made by the body.~   "
84654|NCT01949324|"~     This study is a phase 2, randomized, multi-center, single-masked study to evaluate the~     efficacy and safety of the NT-501 implants in participants with Mactel.~   "
84655|NCT01949311|"~     This is an open label extension study for patients who participated in placebo-controlled~     dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety~     (adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global~     Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating~     Scale (NRS).~   "
84656|NCT01949298|"~     Edentulous patients have to wait after extractions and again after surgical implant~     placement for healing to occur before the implants can be restored and patients can go back~     to normal function. This delay in loading of implants can be handicapping for the patient,~     esthetically and functionally. Hence this project was undertaken with the purpose of~     reducing this wait period and achieving early rehabilitation in these patients. The aim of~     the project is to compare immediate loading versus delayed loading of implant supported~     mandibular dentures.~   "
84657|NCT01949285|"~     This study is to determine if non-invasive electrical stimulation of the spinal cord can be~     used to: 1) assess spared function following a spinal cord injury; and 2) be use for~     rehabilitation.~   "
84658|NCT01949272|"~     Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system~     plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and~     transpulmonary pressure calculation. Opera study should confirm if a setting approach based~     on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious~     side-effect.~   "
84659|NCT01949259|"~     A retrospective, data mining project that re-uses routine patient care data for decision~     support systems.~   "
84660|NCT01949246|"~     The prospective study aims:~        1. To determine the role and mechanism of biomarkers for prediction of response to CRT~        2. To determine the role of biomarkers and their effect on left ventricular remodeling in~          patients undergoing CRT.~   "
84661|NCT01949233|"~     The primary objective of the trial is to estimate the effects of allocation to irbesartan,~     or doxycycline, or a combination of both irbesartan and doxycycline, compared with placebo,~     on measures of elastic function of the aorta in people with the Marfan syndrome and~     enlargement of the aorta.~   "
84662|NCT01949220|"~     Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify~     the therapeutic practices in an international environment.~   "
84664|NCT01949194|"~     In recent years, anti-angiogenic agents have been incorporated into clinical practice for~     the treatment of metastatic CRC, leading to improvements in progression-free survival and~     overall survival. Regorafenib is an oral multi-kinase inhibitor that targets angiogenic and~     oncogenic kinases. Although structurally similar to another multi-kinase inhibitor,~     sorafenib, it appears to be pharmacologically more potent and possesses broader~     antiangiogenic properties.~      Both sorafenib and regorafenib target BRAF wild-type and BRAF V600E mutant but the~     inhibition of p38 MAP kinase is a peculiar characteristic of regorafenib. A Phase I study of~     regorafenib as a single agent in patients with heavily pretreated CRC showed promising~     clinical activity with a disease control rate (PR + SD) of 59% in evaluable patients. In the~     Phase III trial (CORRECT), which was a randomized double-blind, placebo-controlled study~     comparing either regorafenib plus best supportive care (BSC) or placebo plus BSC, it was~     shown that regorafenib significantly increased overall survival (OS), progression-free~     survival (PFS) and disease control rate (DCR), independently of KRAS status. A major~     interest, given the data presented in the CORRECT trial, is to determine predictive~     biomarkers to indicate patients likely to benefit, or to be resistant to this~     anti-angiogenic compound.~      This study aims to determine the efficacy of regorafenib as single-agent treatment for the~     treatment of second-line metastatic colorectal cancer and to identify predictive biomarkers~     in the actual metastatic tumors to be treated. In the case of metastatic CRC patients, liver~     lesions are frequently the most common site of metastatic deposit and these lesions can be~     biopsied to assess putative biomarkers. Patients will be asked to undergo a biopsy of a~     metastatic lesion prior to treatment, and an optional liver biopsy at the time of relapse.~     Using several high-throughput discovery platforms, biomarkers will be identified in the~     metastatic tumor specimens and in blood samples collected throughout the treatment. This~     will allow us to evaluate putative biomarkers and monitor tumor biomarker dynamics using~     serial blood collection.~      The objectives of this trial are to help identify the patient subgroup most likely to be~     responsive or resistant to regorafenib, so that future treatment with regorafenib can be~     directed to the more responsive but as yet identified patient population.~   "
84665|NCT01949181|"~     Prospective research to study the relationship between concentrations of metals/metalloids~     in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive~     pulmonary disease.~   "
84666|NCT01949168|"~     The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy~     for the treatment of genotype 6 chronic hepatitis C infection.~      Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C~     infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic~     hepatitis C infection.~      The investigators therefore hypothesise that:~      i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.~      ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks~     will cure a high proportion of patients chronically infected with genotype 6 chronic~     hepatitis C infection.~   "
84667|NCT01949155|"~     The purpose of this study is to confirm the effectiveness, safety and tolerability of~     OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who~     require tympanostomy tube placement.~   "
84668|NCT01949142|"~     The purpose of this study is to confirm the effectiveness, safety and tolerability of~     OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who~     require tympanostomy tube placement.~   "
84669|NCT01949129|"~     The ALL SCTped 2012 FORUM is a multinational, multi-centre, randomized, controlled,~     prospective seamless phase II/III study for the therapy and therapy optimisation for~     children and adolescents with ALL in CR, who have an indication for HSCT (hematopoetic stem~     cell transplantation) with a myeloablative conditioning regimen.~      The stratification and randomisation of patients in first and following remission according~     to the individual transplantation modalities rests upon an indication for allogeneic HSCT~     AND on the availability of a suitable donor within the individual transplantation groups.~      Main objectives - Objective 1: Randomisation of TBI vs non-TBI conditioning regimen for~     patients with a HLA matched-sibling donor or unrelated HLA matched donor.~      We aim at showing that a non-total body irradiation (TBI) containing conditioning~     (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to~     conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human~     leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD).~      - Objective 2: Stratification of patients with a HLA mismatched donor according to stem cell~     source.~      We aim at exploring event free survival (EFS) after HSCT from HLA mismatched donors using~     mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family~     members with non TBI-conditioning regimen.~   "
84670|NCT01949116|"~     People with HIV infection who are taking antiretroviral therapy (ART) may be at risk for~     cardiovascular disease (CVD), which can be caused by inflammation. Methotrexate (MTX) is a~     medication used to treat inflammation in people with rheumatoid arthritis. This study will~     evaluate the safety and effectiveness of low-dose methotrexate (LDMTX) at reducing~     inflammation in HIV-infected adults.~   "
84671|NCT01949103|"~     TD-1607, administered intravenously as multiple ascending doses, will be investigated in~     healthy subjects to assess its tolerability, safety, and pharmacokinetics.~   "
84672|NCT01949090|"~     The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of~     different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age~     and older. The study will evaluate safety related events and antibody immune responses to~     different formulations of study vaccine.~   "
84673|NCT01949077|"~     The purpose of the study is to determine differences in levels of serum chemokines from~     patients undergoing treatment with Boceprevir. The aim is to determine if non-responders~     have significantly different levels of chemokines than responders.~   "
84674|NCT01949064|"~     The treatment of craniomandibular disorders is a challenging task. Many different treatments~     are yet available with occlusal splints being one of the most commonly used. A relative new~     diagnostic and treatment alternative is the Grindcare device. This enables the~     electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent~     electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a~     certain limit. This stimulation results to a sudden break of the muscle activity.~      Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain~     reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our~     null-hypothesis was that there is no difference between the device and the splint in the~     reduction of pain intensity.~   "
84675|NCT01949051|"~     This study will be a randomized, double blind, placebo controlled, 3-way cross over design~     in allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal~     levocabastine for 7 days in each period and the duration of the study will be about 13~     weeks. An Environmental Exposure Chamber (EEC) will be used in this study. The primary~     objective of the study is to investigate the non-inferiority effect of 7 days treatment with~     levocabastine on nasal symptoms elicited by an EEC when administered once daily (QD)~     compared with twice daily (BID). Also study will be conducted to investigate the superiority~     of effect of 7 days treatment with levocabastine (QD and BID) on nasal symptoms elicited by~     an EEC in subjects compared to placebo.~   "
84677|NCT01949025|"~     1. Summary~           Growing evidence suggests that a significant proportion of in-hospital patient deaths~          occur after serious adverse events (SAE's). Concerns have been raised that too often~          patients' acute deteriorations, particularly on surgical and medical wards outside~          critical care settings, are identified too late and corrective actions taken too~          slowly. Many initiatives have been taken to prevent unexpected death by timely~          recognition, intervention and resuscitation efforts such as Rapid Response Systems~          (RRS's). RRS's have been introduced with the intention to prevent SAE's and to improve~          patient outcome by facilitating early detection of warning signs for clinical~          deterioration. These systems have four components (1) an afferent limb for detection~          and response triggering, (2) an efferent limb with medical or nursing response to~          prevent deterioration (3) a process improvement limb and (4) a governance and~          administrative structure. It remains uncertain which elements of RRS's contribute most~          to patient outcomes such as unplanned (re-) admission to the intensive care unit,~          shock, cardiac arrest and unexpected death. In addition, previous studies found that~          nurse observation, assessment and communication (afferent limb) are crucial to achieve~          better patient outcomes, but how to achieve afferent limb sustainability in hospitals~          is not clear.~           A previous study investigated 23 hospitals in Flanders (Belgium) about how nurses~          observe, assess, detect and communicate deteriorating and critical patients in~          surgical, medical and geriatric wards. Wide variation between hospitals was identified~          about critical patient intervention procedures, strategies and Do Not Attempt~          Resuscitation (DNAR) orders as well as between nurses about the use and knowledge of~          critical vital signs and call criteria for physician clinical advice and support.~          Nurses of hospitals with structured observation and communication protocols were better~          informed and perceived their communication and collaboration with physicians more~          favorable in compared to other hospitals. Based on these results conclusions and~          recommendations for further initiatives were formulated. The proposed Afferent Limb and~          Response Method intervention study will implement these recommendations guided by a~          robust scientific research approach to offer evidence to the nursing and medical~          practice community.~           The aim of this study is to evaluate the effect of the Afferent Limb Ascertainment and~          Response Method intervention or ALARM intervention in medical and surgical nursing~          wards of acute care hospitals on the prevention of SAE's such as in-hospital unexpected~          death, unplanned ICU-admission and cardiac arrest.~        2. Study hypothesis~      Optimizing and supporting the process of observation, use and interpretation of vital signs,~     detection, assessment, escalation and communication with a higher level of care in~     deteriorating patients can prevent serious adverse events (in-hospital unexpected death,~     unplanned ICU admission and cardiac arrest) in acute care hospitals.~   "
84678|NCT01949012|"~     Dentists use sedation to help patients accept difficult procedures and to relieve anxiety.~     During sedation, the well-being of the patient is monitored by the dental team. When carried~     out according to recognised guidelines,intravenous dental sedation is considered to be very~     safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It~     is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen~     status) is the current gold standard in dental sedation. The main risk to the patient during~     sedation is a slowing of breathing due to the effects of the sedative drug. Studies from~     other settings where sedation is practiced suggest that an additional monitor with~     capnography facilitates early detection of depressed breathing. However, the results of~     studies from other medical settings cannot be generalised to dental sedation, because of~     different techniques used and the types of patients. The depth of sedation may also be vary.~     For dental sedation, patients remain responsive at all times and breathe for themselves.~     Capnography gives breath by breath information using a simple device placed close to the~     nose and mouth. It has been recommended by several governing medical bodies that each area~     of medicine, should develop its own guidelines for sedation. Therefore, there is a need to~     research the application of capnography for dental sedation. The proposed study will take~     place at a university hospital site. Patients will be randomly divided into two groups. Both~     groups will receive sedation in the normal way. The study group will have capnography~     monitoring added. The study will look for differences in breathing between the two groups.~     Additional information regarding other aspects of monitoring will also be obtained. The~     results from the proposed study may help to improve patient safety and change current~     practice during sedation for dentistry.~   "
84679|NCT01948999|"~     The purpose of the study is to determine whether addition of electroconvulsive therapy to~     antipsychotic treatment improves the mental health of patients with treatment-resistant~     schizophrenia.~   "
84680|NCT01948986|"~     This is a study to evaluate the effect of renal impairment on the pharmacokinetics,~     pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2~     diabetes mellitus (T2DM) and in healthy participants with normal renal function.~   "
84681|NCT01948973|"~     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with~     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood~     but recent studies have shown changes in both colonic motility and rectal sensibility. We~     have previously shown IBS patients to benefit from sacral nerves stimulation. With the~     present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as~     suprasensory sacral nerve stimulation.~   "
84682|NCT01948960|"~     A study to determine whether everolimus pharmacokinetics in elderly and obese patients is~     different compared to control patients.~      Furthermore the investigators will investigate the relation between metabolic response~     assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus~     exposure and clinical benefit.~      The investigators will explore whether dose escalation in patients who are hypothetically~     underexposed will result in an increase in metabolic response.~   "
84683|NCT01948947|"~     Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild~     traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most~     debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not~     entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive~     transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few~     intractable chronic central pain conditions including headaches. This study aims to 1)~     assess the effect of rTMS in relieving headache and improving neurophysiological functions;~     and 2)explore the neuronal mechanisms associated with MTBI related headache and the~     analgesic effect of rTMS with function magnetic resonance imaging (fMRI).~   "
84684|NCT01948934|"~     The purpose of this study is to determine the safety of use of a new therapeutic strategy~     for the treatment of patients with large wounds~   "
84685|NCT01948921|"~     Our pilot results showed that meperidine reduce patient discomfort during EGD~     (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative~     agents. So we target the use of meperidine on patients expected to have poor tolerance in~     this study, which includ young females with high anxiety level and patients with prior poor~     tolerance. We test the hypothesis that meperidine improves tolerance and alleviates~     discomfort for patients expected to have poor tolerance during diagnostic EGD.~   "
84686|NCT01948908|"~     The purpose of this study is to determine exactly how much drug volume should be~     administered into each nare, so that the drug absorption can be maximized and the amount~     that runs out of the nose, or is swallowed, is minimized, thereby optimizing the~     effectiveness of any drug given intranasally. The investigators will determine this ideal~     volume of administration by studying intranasal midazolam in children who require sedation~     to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as~     well as pharmacokinetic outcomes associated with each volume of administration. We will~     block randomize children to receive intranasal midazolam in maximum aliquots of one of the~     three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.~   "
84687|NCT01948895|"~     This multi-centred study will be conducted at two centres. The design will be an open label,~     flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine~     monotherapy for patients who meet diagnostic criteria for dysthymia.~   "
84771|NCT01947803|"~     The purpose of this study will be to evaluate the safety and treatment response of~     paliperidone palmitate administered to Chinese patients with schizophrenia.~   "
84688|NCT01948882|"~     The Essure System is indicated for women who desire non-incisional permanent birth control~     (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to~     evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent~     birth control in preventing pregnancy. The Essure ESS505 System includes a design~     modification that will be studied to determine if it provides immediate birth control,~     thereby removing the three months waiting period required for the commercially available~     Essure System Model 305 to be effective.~   "
84689|NCT01948869|"~     The study shall explore whether treatment of atopic dermatitis is equally effective with~     respect to a marketed medical device and a new medical device.~   "
84690|NCT01948856|"~     The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of~     Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of~     younger age who develop infectious diseases more frequently than other children of this age~     in general.~   "
84691|NCT01948843|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has~     been used to treat patients that have cancers that require arginine. In this study, ADI will~     be combined with the well known chemotherapy Doxorubicin and the safety and potential~     efficacy of this combination will be explored in patients with HER2 Negative Metastatic~     Breast Cancer.~   "
84692|NCT01948830|"~     This study was designed to evaluate the efficacy and safety of two different regimens of 0.5~     mg ranibizumab given as intravitreal injection in patients with neovascular age-related~     macular degeneration~   "
84693|NCT01948817|"~     This is an open label, single arm, and multicenter study. The study will include the~     following phases. A screening phase which lasts for 4 weeks to determine patient~     eligibility. This phase will be followed by a 24 week Open label treatment phase. The study~     treatment is defined as deferasirox 20mg/kg BID 9Twice a day). Serum Ferritin Levels and MRI~     (Magmetic Resonance Imaging) LIC (Liver Iron Concentration) will be measured to evaluate the~     response to BID.~   "
84694|NCT01948804|"~     The comparison of effect of four different treatment protocols: Antagonist/letrozole~     protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF~     outcomes in poor responders undergoing in vitro fertilization; a prospective~     randomized-controlled study.~   "
84695|NCT01948791|"~     To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate~     Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration~   "
84696|NCT01948778|"~     Septic shock has a high mortality risk despite the availability of various treatments.~     Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger~     of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming~     systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with~     generalized vascular endothelial damage, tissue injury and multi-organ failure.~      Extracorporeal blood purification therapies aim to reduce the circulating level of~     endotoxin. Different extracorporeal blood purification systems are available. The oXiris™~     device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of~     plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of~     the membrane allows absorbing negatively charged bacterial products such as endotoxin. From~     an historical perspective, filters containing AN69-based membranes have been the most~     commonly used products for CRRT in the management of critically ill patients and a~     substantial volume of published data exist.~      Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM~     (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of~     polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the~     polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity.~     Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating~     endotoxin by adsorption.~        -  Trial with medical device~   "
84697|NCT01948765|"~     The investigators hypothesize that the application of 30% xenon as an adjuvant to general~     anesthesia with a target-controlled infusion of propofol is superior to general anesthesia~     with propofol alone with respect to hemodynamic stability.~   "
84698|NCT01948752|"~     The current study sought to examine the effect of menu labeling on food ordering and food~     consumption, including the effect of displaying calories along with other nutrients, such as~     sodium, fat, and sugar, as well as in different formats, such as traffic lights.~      The investigators hypothesize significant differences in the calorie amount of menu~     selections and food consumption across experimental conditions. The investigators anticipate~     that calorie amounts will be significantly higher in the no calorie information) compared to~     each of the other 3 conditions, and significantly lower in the Traffic Light conditions~     compared to calories only condition.~      2) Individuals in Condition 1 (no calorie information) will be significantly more likely to~     underestimate the calorie content of their meals compared to individuals in the intervention~     conditions.~   "
84699|NCT01948739|"~     The purpose of this study is:~        1. To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain~          machine interface (BMI) to actively include patient in the control loop and thereby~          making the therapy 'active'.~        2. To determine appropriate robotic (kinematic data acquired through sensors on robotic~          device ) and electrophysiological ( electroencephalography- EEG based) measures of arm~          motor impairment and recovery after stroke.~        3. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and~          effective in improving arm motor functions in sub-acute and chronic stroke population.~   "
84700|NCT01948726|"~     Hypofractionation with simultaneous integrated boost has been investigated in a few trials~     and appears to be safe and feasible with less lung toxicity in smaller studies.~      Investigators initiated this multicenter phase II prospective trial to analyse acute~     toxicity of hypofractionation with simultaneous integrated boost in patients with early~     breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity~     Grad II according NCI-CTCAE amounts maximum 20%.~   "
84721|NCT01948453|"~     The purpose of this study is to determine whether garlic in adjunct to conventional medical~     treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated~     dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease~     (CAD) patients.~   "
84701|NCT01948713|"~     INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined~     as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology~     causes physical discomfort and impacts the quality of life in a negative manner.~     Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can~     be applied with focus on strengthening the pelvic floor muscles or on muscular synergism.~     OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in~     association with the strengthening of the muscles of the hip in the treatment of stress~     urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It~     aims at assessing objectively the strength of the pelvic floor, the improvement in the~     number of episodes of loss and impact on quality of life. The study will accept up to 40~     women, who will be divided into two groups of physical therapy: group 1 (that will~     strengthen the pelvic floor muscles with Kegel exercises) and group 2 (that will perform~     strengthening the pelvic floor muscles with Kegel exercises associated with the~     strengthening of muscles of the hip). The two groups will be evaluated at the beginning and~     at the end of treatment.~   "
84702|NCT01948700|"~     Hispanic adolescents experience more severe alcohol-related consequences due to their~     alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment,~     particularly among justice-involved youth. Despite the level of research that has been~     conducted on motivational interviewing (MI) with mainstream samples, no published studies~     have investigated the efficacy of this brief, individual intervention with Hispanic~     adolescents. The overarching objective of this application is to evaluate the efficacy of a~     brief individual intervention (MI) for problem drinking behaviors with a sample of~     justice-involved Hispanic and Caucasian adolescents to determine if this intervention is~     differentially effective between Hispanic and Caucasian adolescents. Specifically, the first~     aim is to determine whether an MI intervention targeting alcohol abuse is effective at~     reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers.~     The second aim is to examine whether the effects of MI on problem drinking outcomes (e.g.,~     alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic~     versus Caucasian adolescents. Because it is important to determine the mechanisms that~     mediate the effects of MI and determine whether these mechanisms differ between Caucasian~     and Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian)~     moderates the mediational linkages in the overall model using a cross-groups approach to~     moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved~     alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI~     interventions (one at baseline and a second, one week later) or an education condition. All~     adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The~     proposed research is expected to take a significant step towards reducing current~     racial/ethnic health disparities in alcohol treatment for Hispanic adolescents.~   "
84703|NCT01948687|"~     AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in~     noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis~   "
84704|NCT01948674|"~     The purpose of this study is to see if computer tasks that challenge the brain (cognitively~     stimulating tasks) can improve memory and other types of thinking in adolescents and young~     adults who are being treated for substance use problems. The study will compare the effects~     of different versions of the computer tasks.~   "
84705|NCT01948661|"~     Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for~     testing agents with potential cancer prevention.~      Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric~     (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In~     vivo data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood~     levels of parent agent than natural curcumin.~      Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside~     (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the~     Apc(Min) mouse model.~      The investigators hypothesize that the combination of both agents will decrease the~     expression of proteins involved in colon tumorigenesis relative to placebo.~      The change of biomarker expression between pre-treatment biopsy and post-treatment~     endoscopic resection in the target adenoma and the normal rectal mucosa will be the response~     measures.~      The primary response measure is the change of immunohistochemical (IHC) expression of~     β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are~     the changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and~     apoptosis by P53 in adenomatous and adjacent normal mucosa.~      The study design is a phase II, randomized, double blind, placebo controlled, window of~     opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo.~     Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable~     to immediate complete removal will be enrolled in a 4-week intervention trial before~     endoscopic polypectomy.~      The demonstration of a biological activity of the two agent combination may provide the~     rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk~     subjects.~   "
84706|NCT01948648|"~     If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further~     reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that~     treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma~     concentrations of sitosterol and other plant sterols in sitosterolemia patients.~   "
84707|NCT01948635|"~     The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce~     microaspiration of gastric content as determined by pepsin level in tracheal aspirate.~   "
84708|NCT01948622|"~     This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in~     patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.~   "
84709|NCT01948609|"~     PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2~     mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or~     nonsurgical management. The investigators will compare the change in cardiovascular health,~     bone health, sexual function, quality of life, and menopausal symptoms over 3 years of~     follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched~     controls that do not undergo RRSO.~      The investigators hypothesis is that women who undergo a premature surgical menopause~     induced by RRSO have worse cardiovascular health and bone health compared with women who do~     not undergo RRSO.~   "
84710|NCT01948596|"~     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty~     acids for pregnant women with depressive symptoms.~   "
84711|NCT01948583|"~     Aim of the study is to evaluate the humectant activity and the local tolerability of a new~     formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years)~     with referred vaginal dryness~   "
84712|NCT01948570|"~     Primary end point of the study is the clinical and non-invasive instrumental evaluation of~     the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade~     and 20 subjects with a moderately severe/severe grade, according to Cunliffe'~     classification.~      Secondary end-points are the cosmetic acceptability and efficacy evaluation by the~     volunteers and the local tolerability assessed by the investigator and the subjects.~   "
84735|NCT01948271|"~     The purpose of this research study is to better understand whether trichuris suis ova (TSO)~     ingested orally may be safe and effective in the treatment of psoriasis.~   "
84736|NCT01948258|"~     This study will assess the use of the new Clearblue Advanced Fertility Monitor for one~     menstrual cycle in a home setting by female volunteers seeking to get pregnant.~   "
84713|NCT01948557|"~     Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of~     HIV infection being passed to her child either during pregnancy or during the labour~     process. However, children can also become infected by drinking the mother's breastmilk~     which contains the HIV virus. In many poor, developing countries in Africa, breastfeeding is~     the normal way of infant feeding and is vitally important because of the protection it gives~     to children from other diseases such as diarrhoea and malnutrition. Ideally there would be a~     way to make breastfeeding safer from HIV transmission without losing its other advantages.~      A medical study recently suggested that HIV-infected women who exclusively breastfed their~     children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods~     did not pass on the virus to their children to the same degree as women who MBF with these~     other fluids and foods. It is important to confirm whether this observation is in fact true~     or not. We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower~     risk of HIV transmission than mixed breastfeeding.~      We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women~     from the time that they book at the clinic until 24 months of age. HIV-infected women who~     say they intend to breastfeed and all the HIV-uninfected women will be visited at their~     homes by breastfeeding counsellors both before and after delivery to support exclusive~     breastfeeding. HIV-infected women who choose not to breastfeed will be helped by clinic~     staff to safely replace all breastmilk with some other milk. An independent team will visit~     all mothers at their homes and collect information about the way they feed their children.~     Blood samples will be collected from the children at different times by a simple heel prick~     and the blood stored on a piece of filter paper. By testing these samples and comparing with~     the type of feeding at that time, we will be able to see when a child becomes infected and~     whether exclusive breastfeeding gives any protection.~   "
84714|NCT01948544|"~     -  Evaluate subjects in an prospective observational study~        -  Subjects will be administered scientifically validated questionnaires~        -  Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:~             1. Exercise capability, dyspnea and quality of life as primary endpoints~             2. Utilize:~                  1. Baseline Dyspnea Index (BDI)~                  2. Transitional Dyspnea Index (TDI)~                  3. Chronic Respiratory Disease Questionnaire (CRQ)~                  4. Six minute walk test (6MWT)~                  5. Epworth Sleepiness Scale (ESS)~        -  The secondary endpoints will be:~             1. Rate of exacerbations, sleep quality~             2. Health care utilization (emergency room encounters, hospital admissions)~   "
84715|NCT01948531|"~     Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the~     antiage activity of Gynomunal® gel after one single application on the face (short term~     evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female~     volunteers.~      It is also aim of this study to evaluate cosmetic acceptability by the volunteers and~     efficacy and tolerance both by investigator and volunteers.~   "
84716|NCT01948518|"~     The purpose of this study was to investigate the acute effects of sildenafil on diffusion~     capacity, a commonly performed pulmonary function test, which is used to assess the lungs'~     gas exchange capability.~      This study does not assess safety or efficacy of the drug. The study does not have clinical~     end points. The variables studied are diffusion capacity and 6 minute walk after a single~     dose of sildenafil.~      This study has been completed.~   "
84717|NCT01948505|"~     To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient~     pain.~      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation~     levels in neurocritically ill patients.~      To assess the effect of an intravenous nonnarcotic pain medication on common side effects~     seen in patients taking other intravenous narcotic pain medication in the neurocritical care~     unit.~   "
84718|NCT01948492|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the~     nitrogen balance method have been well described. Importantly, nitrogen balanced~     underestimates requirements.~      The current dietary reference intake (DRI) requirement for healthy adult males is based on~     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was~     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of~     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using~     IAAO, our group estimated the protein requirement of young men (mean age 27 years) to be~     0.93 and 1.2 g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by national health and nutrition examination survey (NHANES), the authors~     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0~     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending~     on the calculations used for ideal body weight some older adults could be getting higher or~     lower than requirement. There is no scientifically derived protein estimate for older~     adults. Therefore there is a need to measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of male elderly~     subjects > 75 years using the indicator amino acid oxidation (IAAO) technique.~      Hypothesis:~      The investigators hypothesize the protein requirement in elderly male subjects will be lower~     (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).~   "
84719|NCT01948479|"~     Insoles are designed to reduce increased loads and re-ulceration risk in patients with~     diabetes. The investigators previous research findings suggest that an instant insole~     solution may benefit some, but effectiveness is difficult to predict. The investigators~     propose a feasibility study using in-shoe pressure analysis to optimise the protective~     effect of insoles and footwear with the aim of reducing re-ulceration rates.~      Early indications from exploratory case studies within the real world clinical setting~     suggest that by implementing the investigators previous published research findings the~     investigators can optimise effectiveness and reduce outcome variability of protective~     footwear and insoles provided to patients at risk of re-ulceration.~      However a further randomised control trial is necessary to evaluate the effectiveness of~     in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The~     proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic~     foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear~     provision or 2) Routine insole and footwear provision, and temporary insole provision with~     optimisation. The findings from the feasibility study will inform protocol development for a~     larger clinical trial. The results of the feasibility study will be used to strengthen a~     protocol for a grant application to conduct the main RCT. A secondary output from the pilot~     study will be the dissemination of findings in a peer reviewed journal and at conference.~   "
84720|NCT01948466|"~     The overall goal of this project is to learn how positive advertising messages impact school~     food choices. More specifically, this study will determine if positive video messages about~     fruits and vegetables delivered during the elementary school morning news program can~     influence children to select more fruits and vegetables in a school lunch setting.~     Additionally, it will determine if assessing food selection is representative of food~     consumption by children in a school lunch room setting.~   "
84722|NCT01948440|"~     Making referrals to medical and psychosocial services for substance abuse clients has proven~     difficult due to lack of access to services, inadequate counselor knowledge, and lack of~     motivation and skills among clients. Inflexxion is proposing the development of ASI-MV~     Solutions, which will educate clients about employment, legal, psychiatric, relapse~     prevention, medical, and family issues, as well as include resources and strategies for~     counselors. By linking learning modules to client results on the ASI-MV, an online~     interactive version of the ASI administered in treatment settings, we will be able to offer~     clients important tools to address key recovery issues and encourage counselors to make~     appropriate referrals to medical and psychosocial services.~   "
84723|NCT01948427|"~     THRIVE is an observational study that will collect information on patients with UCDs. THRIVE~     will follow enrolled participants for up to 10 years. As an observational study, enrolled~     patients will not be required to make any additional office visits or take any medicine~     outside of normal care.~   "
84724|NCT01948414|"~     The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to~     investigate the cognitive process. The P300 component are accepted as electro-physiological~     markers of neuropsychiatric disorders like alcoholism or drug addiction.~      Recent scientific data suggest that eating disorders, leading to weight gain and obesity,~     will be similar of those of drug addiction: it is the incentive sensitization theory that~     implicates the dopaminergic reward system.~      The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP~     in obese women with eating disorders in comparison with obese and lean women without eating~     disorders.~   "
84725|NCT01948401|"~     This interventional, open study will evaluate clinical data in relation to biomarkers in~     patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma.~     Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose~     of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in~     a future placebo-controlled intervention study designed to measure the steroid-sparing~     effect of lebrikizumab.~   "
84726|NCT01948388|"~     The purpose of the study is to evaluate the effect of the utilization of two doses of~     corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as~     an alternative to conventional steroid therapy by evaluating the change from baseline in the~     clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI).~     Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA~     patients using disease-modifying antirheumatic drug (DMARD) therapy alone.~   "
84727|NCT01948375|"~     Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have~     applied a new kind of placebo needle in large scale acupuncture clinical trials, which named~     as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials,~     this pragmatic placebo needle shows several advantages: the outlook closer to traditional~     acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and~     more economical. However, its blinding effect is not yet validated. The primary objective of~     this trial is to validate the blinding effect of the new pragmatic placebo needle; the~     secondary objective is to explore factors influencing the blinding effect of the placebo~     needles.~   "
84728|NCT01948362|"~     To determine the safety and tolerability of single escalating doses of Sulforadex® in~     healthy male volunteers.~   "
84729|NCT01948349|"~     The advantage of self-ligating brackets on periodontal health has yet to be determined. In~     addition, the utilization of tongue scraping as an adjunct to traditional oral hygiene~     measures has yet to be studied in orthodontic patients. The aim of this study is to evaluate~     the effect of bracket type on plaque accumulation and also the impact of the appliance on~     oral malodor. In addition, the effect of tongue scraping on halitosis will be studied in~     patients undergoing orthodontic treatment. We hypothesize that self-ligating brackets will~     harbor less plaque than normal brackets, that tongue scraping will significantly decrease~     halitosis in patients undergoing orthodontic treatment and that patients with self-ligating~     brackets will exhibit less halitosis as measured by halimeter.~   "
84730|NCT01948336|"~     The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage~     renal function.~   "
84731|NCT01948323|"~     The purpose of this study is to investigate whether overweight but not obese pregnant~     African women having unlimited access to a health education-information technology (IT)~     based intervention package gain weight within the acceptable range of 8-12 kg during the~     pregnancy period.~      Therefore, we hypothesize that unlimited access to health education via an IT-based~     intervention package has the potential to reduce the onset of obesity in African pregnant~     women.~      To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been~     screened and 150 enrolled into the study~   "
84732|NCT01948310|"~     The primary objective is to assess whether the increased angina threshold on ranolazine and~     subsequent higher training intensity will result in improved exercise tolerance and oxygen~     consumption; and greater than that observed with exercise training on placebo. The study~     team anticipates the chronic exercise improvements with ranolazine will be incrementally~     higher than the acute effects provided by ranolazine alone and demonstrated in previous~     trials. Key secondary objectives include the acute ranolazine and chronic exercise plus~     ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of~     life.~   "
84733|NCT01948297|"~     This study is primarily designed to assess the safety and the tolerability of Debio1347~     (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration~     of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment~     does not exist or is not indicated.~      The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate~     the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally~     administered daily to these patients, in order to determine the recommended dose.~      The main objective of Part B is to evaluate the safety profile at the recommended dose, in a~     larger cohort of these patients.~   "
84734|NCT01948284|"~     This prospective, randomize, controlled trial will compared maximal to half-maximal suction~     pressure applied during water exchange in patients undergoing minimally sedated colonoscopy.~     We test the hypothesis that maximal suction pressure is more efficient and causes shorter~     insertion time.~   "
84741|NCT01948193|"~     The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-~     Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14~     weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface~     antigen (HBsAg) serology negative in India.~      Primary Objective:~        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection~          [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae~          type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for~          pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one~          month after the third dose.~      Secondary Objectives:~        -  To further describe the immunogenicity of the study vaccine, before the first dose and~          one month after the third dose.~        -  To describe the safety after each and any doses of the study vaccine.~   "
84742|NCT01948180|"~     To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients~     with aggressive EBV positive extranodal NK/T-cell lymphoma~   "
84743|NCT01948167|"~     This project, which will innovatively combine risk factor research and evidence-based~     prevention programs, will advance knowledge on personalized approaches to prevention that~     may be able to betterbend trajectories of depression that surge throughout adolescence. A~     randomized controlled trial will deliver equal doses of IPT-AST and CWS for the prevention~     of depression in adolescents. These two programs are designed to address distinct risk~     factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal~     risks. A total of 210 participants across two sites, University of Denver and Rutgers~     University, will be stratified on cognitive and interpersonal risk and randomized to the two~     conditions. The goals of the study are to (1) demonstrate that prevention programs can~     modify depression trajectories among youth by examining within person changes in~     trajectories over time (three years before and three years after the prevention programs)~     and by comparing trajectories of prevention youth with changes in same aged cohorts; (2)~     evaluate a personalized prevention approach to bending depression trajectories by matching~     and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3)~     examine mechanisms of bending depression trajectories and test whether the prevention~     programs operate via their hypothesized processes; and (4) explore how genetic~     susceptibility, emotion regulation, and temperament may affect individual response to~     IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of~     prospective naturalistic data collection, this study will contribute essential data on~     personalized medicine and altering developmental trajectories of first-onset depression.~   "
84744|NCT01948154|"~     Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions~     that cause physical disability in human development. It is not infrequently to note~     concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many~     studies have documented Cerebral palsy is associated with a variety of neuromotor disorders~     that frequently affect the speech production system. The speech function impairment varied~     widely due to different severity of diseases involved. The investigators hypothesize such~     impairment of speech function may affect degree of social participation and eventually the~     quality of life (QoL).~   "
84745|NCT01948141|"~     This phase II trial studies how well nintedanib works in treating patients with advanced~     non-small cell lung cancer who have failed up to two previous chemotherapy regimens.~     Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
84746|NCT01948128|"~     This protocol is a randomized, phase 2 window of opportunity trial assessing the~     biological effects of short term oral vitamin D administration on breast cancer clinical and~     translational markers in patients awaiting surgery at the Ottawa Hospital. It takes~     advantage of the current wait times (2-8 weeks) for breast cancer surgery as a window of~     opportunity to rapidly assess biological changes with vitamin D intake.~   "
84747|NCT01948115|"~     The variety of breech presentation at term is about 3-4% of all births. Our study aims to~     assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some~     patients algic or relaxed, the success rate seems more important.~      It's a single blind prospective randomized controlled study, comparing success rate of ECV~     after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).~      We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we~     will give the patient a satisfaction questionnaire. We compare the success rate of ECV as~     primary outcome.~   "
84748|NCT01948102|"~     The purpose of the project is to obtain skin and adipose tissue samples from patients with~     ALS to develop new diagnostic and prognostic markers of the disease. These samples will be~     obtained when percutaneous endoscopic gastrostomy (PEG) is performed as part of their~     standard of care. Skin and adipose tissue samples will also be obtained from disease control~     subjects who require a PEG as part of their standard of care.~   "
84749|NCT01948089|"~     This project will investigate the effectiveness of an intensive and focused working memory~     training program for chronic stroke patients. The investigators hypothesize that working~     memory training will be an effective method of improving working memory and related~     cognitive and behavioural functions in this population.~   "
84750|NCT01948076|"~     The 40 resident study subjects will be randomized to either receive a training session on~     use of a pocket-sized ultrasound or to receive training on physical exam skills. Following~     these sessions the subjects will have the opportunity to practice their skills during~     clinical rounds at BWH inpatient and outpatient settings. Four weeks after the training~     session all study subjects will take part in an assessment of their diagnostic skills.~     During this assessment they will be asked to complete an exam on a patient subject. Those~     randomized to the ultrasound group will be allowed to use their devices while the control~     group will use the traditional physical exam. Following the exams, resident study subjects~     will be asked to indicate whether they detected any of the following abnormalities on their~     exams: pleural effusion, hepatomegaly, cirrhotic liver, splenomegaly, ascites, aortic~     stenosis, mitral regurgitation, right atrial pressure, abdominal aortic aneurysm, deep vein~     thrombosis. Resident study subjects will also complete a questionnaire about the physical~     exam and use of the ultrasound. Prior to the assessment, all patients will undergo~     ultrasound by an attending radiologist, and these results will serve as the gold standard~     for our study.~   "
84751|NCT01948063|"~     This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate~     mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.~   "
84757|NCT01947985|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
84758|NCT01947972|"~     Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a~     high percentage of amino acids from the first day of life in order to achieve normal~     neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia,~     increased visceral fat) that this type feeding, in conjunction with complexity of~     prematurity, is likely to cause. Current study aims to investigate is whether individualized~     fortification of breast milk protein, based on the mother's milk protein content and~     targeting the recommended daily protein requirements, is associated with better nutrition,~     growth, biochemical and endocrine markers associated with the nutrition of preterm low birth~     weight neonates, compared to the standard fortification of human milk.~   "
84759|NCT01947959|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
84760|NCT01947946|"~     The purpose of this study is to determine whether Benralizumab reduces the number of asthma~     exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.~   "
84761|NCT01947933|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3074828. The study will investigate how the body processes the study drug and how the drug~     affects the body. The study will last about 3 months for each participant.~   "
84762|NCT01947920|"~     The purpose of this study is to determine the safety and tolerability profile of tramadol~     hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported~     by currently available toxicology and clinical data (200 mg to 600 mg per day).~   "
84763|NCT01947907|"~     A six month study of ACP-001, a long-acting growth hormone product, versus standard human~     growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone~     (hGH) will be given on a daily basis. The primary aim is to demonstrate safety,~     pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is~     the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH~     treatment group.~   "
84764|NCT01947894|"~     The purpose of this study is to assess the long term treatment outcomes of Growth Hormone~     treatment in patients who are prescribed and treated with Genotropin. Also, plan to~     determine the relationships between clinical status, dosage schedule and response to~     Genotropin treatment.~      This study will also contribute to our knowledge of adult Growth Hormone Deficiency,~     including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.~   "
84765|NCT01947881|"~     The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in~     eyes that show different response to treatment with anti-VEGF (vascular endothelial growth~     factor) injections of Lucentis.~   "
84766|NCT01947868|"~     This is an open-label, non-interventional, single-arm, multicenter study in a real-world~     population to assess the clinically symptom improvement and quality of life (QoL) in~     patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive~     EGFR-TKIs as the first-line treatment.~      The Primary Objective is to estimate symptom improvement rates in patients with locally~     advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the~     first-line treatment. A clinically meaningful improvement is defined as an increase from~     baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.~   "
84767|NCT01947855|"~     To evaluate the efficacy of empagliflozin administered orally once daily in postprandial~     glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as~     mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic~     control on no antidiabetic treatment.~   "
84768|NCT01947842|"~     This research study is to see if smartphone applications help college women remember to take~     birth control better than pharmacist consultation alone. Patients will participate in this~     study for 6 (six) months. The study will have two groups. Patients will be randomly assigned~     to one group or the other. The control group will be counseled by the pharmacist on the~     importance of taking birth control as prescribed. The study group will get the same~     counseling, but will also be set up to receive reminders to take medication on a smartphone~     application called Dosecast.~   "
84769|NCT01947829|"~     Session-to-session variations in delivered Kt/V that may cause failure to achieve the~     prescribed dialysis dose may be significant in regular clinical practice. To date, this is~     not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of~     prescribed dialysis dose may be caused by low effective treatment time, vascular access~     dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value~     variability or others which may vary from session to session. Patients close to recommended~     target limits of dialysis dose may thus be randomly attributed to be adequately or~     inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is~     recommended.~      Adimea allows easy Kt/V determination in every session and thus documentation of the monthly~     achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of~     session-to-session variability as well as knowledge of dialysis dose monitoring at every~     dialysis may enhance and secure delivery of adequate dialysis.~      The main objective is the estimation of the pooled within-patient SDs (standard deviation)~     for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of~     Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target~     achievement is assessed by monitoring dose by Adimea at every dialysis. This shall~     demonstrate that session-to-session variability can be decreased with usage of Adimea.~   "
84770|NCT01947816|"~     This investigation will be conducted to obtain the following information regarding the use~     of Humira 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Ulcerative Colitis.~        1. Unknown adverse reactions (in particular, clinically significant)~        2. Incidence and conditions of occurrence of adverse reactions in clinical practice~        3. Factors likely to affect the safety and effectiveness~   "
84772|NCT01947790|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2~     diabetes is understandably directed toward treating coronary artery conditions. However~     there are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even~     in the absence of hypertension. It is a strong predictor of cardiovascular events and~     all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality~     than either multivessel coronary disease or impaired left ventricular function. Regression~     of LVH has been associated with an improved prognosis, independent of change in blood~     pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD~     might will be reduced if we can find novel therapies to regress LVH.~      Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can~     regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this~     study, we will treat patients with pioglitazone, and we will also metformin as control.~   "
84773|NCT01947777|"~     To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the~     pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when~     administered with rifampin in healthy subjects~   "
84774|NCT01947764|"~     In the resource-limited settings where most HIV-infected children live, neither the most~     effective strategies to inform children of their HIV status, nor the impact of disclosure is~     well understood. This team's long-term goal is to provide evidence to improve the chronic~     disease management of HIV-infected children in resource-limited settings. The purpose of~     this study is to assess the effect of a patient-centered intervention guiding disclosure to~     HIV-infected Kenyan children using a randomized trial comparing the intervention to routine~     care. The primary endpoint will be probability of disclosure among children, with secondary~     endpoints of adherence, clinical outcomes, psychological distress and social outcomes. This~     work will be done within the Academic Model Providing Access to Healthcare (AMPATH) which~     currently cares for almost 120,000 adult and pediatric HIV-infected patients in 25 clinics~     in Kenya. We will utilize the excellent infrastructure of this academic partnership to~     provide the first comprehensive assessment of the physical, psychological, and social impact~     of disclosure for HIV-infected children in East Africa. We will evaluate the impact of an~     intensive disclosure intervention by pursuing these specific aims: Aim 1: Expand and modify~     an existing pediatric HIV disclosure intervention used in Kenya to include patient-centered~     components; Aim 2: Perform a randomized trial to compare the impact of clinic implementation~     of the culturally adapted, pediatric disclosure intervention on the prevalence of disclosure~     and on the medical, psychological, and social outcomes for HIV-infected Kenyan children ages~     10-15 years compared to children exposed to standard clinical care. The usual care control~     arm will have disclosure training for all clinicians, disclosure chart materials, and an~     existing protocol to implement disclosure for patients over 10 years. The disclosure~     intervention will consist of patient-centered materials to guide disclosure, including~     videotaped narratives; disclosure counselors; post-disclosure child support groups; and the~     usual care resources. The central hypothesis is that an intensive disclosure intervention~     based on culture-specific qualitative work and a patient-centered approach will allow for~     disclosure in which more children know their HIV status at younger ages, and they also have~     improved medication adherence, improved medical outcomes, unimpaired psychological outcomes,~     and no increase in experienced stigma over time.~   "
84775|NCT01947751|"~     Central venous catheter(CVC)-related infection is an inherent complication of this device~     that should be treated promptly. However, there are doubts about the need for the immediate~     withdrawal of CVC while there is still no confirmation of such infection. The aim of this~     study is to compare the resolution of CVC-related infection, testing two approaches:~     catheter´s early exchange, when the possibility of related sepsis is considered, versus the~     maintenance of the CVC and early antibiotic therapy until the infection is confirmed.~   "
84776|NCT01947738|"~     Psoriasis is an inflammatory autoimmune disease that might be controlled by a cathepsin S~     inhibitor like VBY-891.~   "
84777|NCT01947725|"~     The purpose of this study is to examine whether behavioral activation as an adjuvant to~     standard smoking cessation treatment improves smoking cessation outcomes among veterans with~     PTSD relative to a comparably intense combination of standard smoking cessation treatment +~     health and smoking education. It is expected that behavioral activation will produce more~     successful results than health and smoking education when paired with standard smoking~     cessation treatment.~   "
84778|NCT01947712|"~     Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally~     high risk for cardiovascular events. Oxidative stress seems to play a role in impairing~     flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa~     seems to exert artery dilatation via oxidative stress inhibition.~      OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation~     via down-regulation of NOX2, the catalytic core of NADPH oxidase.~   "
84779|NCT01947699|"~     Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is~     called gestational diabetes, and it places both mom and baby at risk for complications.~     Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug~     is a medication taken by mouth that decreases sugar levels in the blood. It is known to~     decrease the risk of complications linked to diabetes in pregnancy. Recent studies in~     pregnancy have described a difference in the way and how well the drug works compared to~     when used outside of pregnancy.~      Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to~     lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth)~     blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not~     FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in~     pregnancy.~      This research study will help us learn more about the variations in blood sugar levels in~     women with diabetes in pregnancy who are taking glyburide and how changes in the timing of~     when the glyburide is taken would affect blood glucose levels. The goals of this study are:~        -  To find the how glucose changes throughout the day in women with diabetes in pregnancy~          receiving glyburide~        -  To learn the effect of changing the time of taking glyburide on glucose levels~        -  To learn the effect of changing the time between glyburide doses on glucose levels~        -  To see if insulin is secreted the same throughout the day in response to a morning dose~          of glyburide.~   "
84780|NCT01947686|"~     The purpose of the study is to determine the survivorship rate of robotically guided~     isolated patellofemoral implants at 2, 5 and 10 year postoperative.~   "
84795|NCT01947491|"~     The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for~     topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to~     Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.~   "
84796|NCT01947478|"~     The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the~     interventional treatment of de novo and non-stented restenotic lesions in the superficial~     femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with~     standard percutaneous transluminal angioplasty (PTA).~   "
84781|NCT01947673|"~     Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due~     to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during~     hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of~     cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH,~     and whether mindfulness meditation might improve BP during dialysis in these patients. The~     investigators will first determine if increased adrenaline levels during volume removal~     contributes to IDH. The investigators will then determine lack of suppression of adrenaline~     levels in the setting of a high BP also contributes to IDH. This will be done by~     manipulating blood pressure by using small amounts of vasoactive drugs, and determining if~     an appropriate response in adrenaline levels occurs. Lastly, the investigators will~     determine if an intradialytic mindfulness meditation program improves BP and adrenaline~     levels in ESRD patients with IDH.~   "
84782|NCT01947660|"~     This study aims to assess the safety of using continuous regional anesthesia for~     post-operative analgesia during septic limb orthopedic surgery.~      The study hypothesis is that continuous regional anesthesia would not induce septic~     complication in the operated limb and could improve post-operative recovery.~   "
84783|NCT01947647|"~     Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for~     individuals with depressive and anxiety disorders. However, CBT is largely underutilized~     within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings~     necessary to deliver the large number of CBT protocols. Transdiagnostic CBT, in contrast, is~     specifically designed to address numerous distinct disorders within a single protocol. This~     transdiagnostic approach has the potential to dramatically improve the accessibility of CBT~     within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research~     seeks to evaluate the efficacy of a transdiagnostic CBT by assessing clinical outcomes and~     quality of life in VAMC patients with depressive and anxiety disorders throughout the course~     of treatment and in comparison to an existing evidence-based psychotherapy, behavioral~     activation treatment.~   "
84784|NCT01947634|"~     Prospective, observational cohort study to investigate the prevalence of sleepiness and~     sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth~     Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in~     all subjects.~   "
84785|NCT01947621|"~     This is a multicenter, multinational, prospective and retrospective, observational study of~     patients with Takotsubo cardiomyopathy (TTC).~      Data on natural profile (demographical characteristics, clinical phenotype, laboratory~     values, electrocardiography parameters, echocardiography parameters, coronary angiography~     parameters, medication) and outcome are systematically collected.~      Our aim is to gain a better insight into the clinical profile and pathophysiology of TTC.~   "
84786|NCT01947608|"~     Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to~     patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in~     countries where ALK inhibitors are not approved or available. The protocol will further~     evaluate the safety of LDK378 in patients with ALK(+) NSCLC.~   "
84787|NCT01947595|"~     The purpose of this prospective randomized multicenter intervention study is to determine~     whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a~     conventional lifestyle intervention in high risk non-Responder subjects. Further, the~     intensive phenotyping to determine subgroups with an increased risk for diabetes enables an~     individualized prevention and therapy of type 2 diabetes mellitus.~   "
84788|NCT01947582|"~     The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the~     spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality~     of life in select individuals living with MS. The hypotheses of the study are: 1.~     Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal~     gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in~     walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in~     muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate~     improvements in quality of life.~   "
84789|NCT01947569|"~     Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired~     dendtritic cells to maintain and improve functional residual beta cell mass in new onset~     Type I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and~     summarized.~      Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new~     onset T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired~     immunoregulatory dendritic cells (iDC) will safely preserve and/or increase B-cell mass~     resulting in improvement and/or normalization of blood glucose levels and glycated~     hemoglobin A1c.~   "
84790|NCT01947556|"~     The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of~     the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by~     jet-injection to that of the same insulin injected with a conventional pen in the management~     of hyperglycemia in subjects with diabetes~   "
84791|NCT01947543|"~     The aim of this study is to screen a well characterized patient population with ventricular~     tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator~     (ICD) for mutations in the calmodulin genes.~   "
84792|NCT01947530|"~     The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked~     devices compared to standard bronchoscopy.~   "
84793|NCT01947517|"~     The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a~     higher rate of retention than Superflex punctal plugs (Brand B).~   "
84794|NCT01947504|"~     The objective of the study is to implement and measure the efficiency of a standardized~     acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety~     - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments.~     The ultimate goal is to have patients be re-integrated to their activities faster with~     lesser symptoms and have patients present lesser post-concussive symptoms. Specific~     objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on~     PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI;~     2)To redefine a model of outcome prediction following mild TBI.~   "
84806|NCT01947348|"~     To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction)~     has an effect on pain and inflammation associated with Osteoarthritis.~   "
84797|NCT01947465|"~     Backgound and relevance of the project:~      Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of~     contracting infections. The increased risk can be attributed to the immunological disorder~     itself, as well as to the immunosuppressive treatment. Vaccination against many infections~     is recommended in this patient group. However, the immunogenicity of vaccines may be reduced~     and may also be influenced by the administered treatment. Potential reactivation of the~     underlying disease triggered by vaccination is another important concern.~      From the patients' and public health perspectives, an important task of physicians is giving~     advice on vaccines. Completing this task is often difficult, because data on the~     immunogenicity and safety of vaccines in these patient groups are scarce, especially with~     regard to treatment with new immunosuppressive medications, such as biological agents.~     Lastly and importantly, due to new therapeutic options, health among AIIRD patients has~     considerably improved and an increasing number of patients undertake overseas travel~     activities requiring additional vaccinations. In this context, reliable advice with regard~     to vaccinations is almost impossible, because for most travel vaccinations the~     immunogenicity and safety profile is unknown.~      Research addressing the immunogenicity and safety of vaccines in different autoimmune~     inflammatory diseases treated with different immunosuppressive medications is urgently~     needed to allow giving evidence based vaccine advice.~      In this observational study the immunogenicity and safety of tetanus booster and hepatitis A~     vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a~     function of the underlying disease and the possible influence of commonly used~     immunosuppressive drugs on the immune response will be studied.~      Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of~     the most frequently recommended vaccinations, and the effect of a booster vaccination can be~     addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their~     importance, only very limited data are available for tetanus and hepatitis A vaccine in this~     patient group. By focusing on these vaccines the study will lead the way to the evaluation~     of further vaccines.~      The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are~     as immunogenic and safe in AIIRD patients as in healthy controls.~   "
84798|NCT01947452|"~     Chicago's Department of Family and Support Services will be providing summer employment and~     social-emotional skill training to youth over the summer of 2012. The investigators are~     partnering with them to evaluate the effects of the program. The investigators will track~     applicants to the program through existing administrative databases to assess the short- and~     long-term effects of the government's program. The investigators hypothesize that the~     program will decrease violence involvement and criminal activity, increase schooling~     engagement, and increase future employment outcomes.~   "
84799|NCT01947439|"~     The risk of restenosis in the treatment of coronary artery disease has significantly~     lessened thanks to the introduction of Drug eluting stent.~      Yet, debates on the efficacy and safety of stents in complex lesions or patients have been~     circulated.~      Recently, PCI in multiple lesions is universally performed with the development of effective~     stents in various kinds in the clinics.~      However, a randomized study is rare for multi-vessel coronary artery disease in real~     procedural environments.~      The primary purpose of this study is to evaluate the clinical progress of biolimus~     A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.~   "
84800|NCT01947426|"~     In the present study, we evaluate the effect of the mother suplementación with DHA during~     the gestation and lactation on diverse aspects of the development of newborn. The effect on~     the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual~     development was studied. Women will in the sixth month of pregnancy, consume a diet balanced~     during last 3 months of pregnancy and the whole lactation. In addition the women will divide~     in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the~     effects on the development of the newborn child; whereas another group will receive a~     placebo. Different samples of blood of the mother and of mother milk will be taken and we~     will correlating her lipidic profile with the brain development of the newborn child,~     evaluated by different tests.~   "
84801|NCT01947413|"~     The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor~     function within each patient's prognostic potential, preventing the development of secondary~     conditions that impact life-long health, and promoting patient's participation in their~     lives. In addition to employ clinical measures after treatment, usual outcome measures~     employed in the intervention studies included movement kinematics (spatio-temporal~     characteristics of movements). Recent reports have suggested repetitive transcranial~     magnetic stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with~     stroke. A novel rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS~     (iTBS) and continuous TBS (cTBS), that modulates human cortical excitability differently.~     However, there is lack of literatures in verifying the treatment effect by the integration~     of clinical and kinematic analysis. Until now, there are no conclusive results regarding~     optimal rTMS protocol, such as stimulating pattern and for patients with stroke.~     Additionally, few studies investigate the possible clinical characteristics of patients with~     stroke that may influence the effects of various treatment protocols proposed in this~     project.~   "
84802|NCT01947400|"~     Patient satisfaction is an important aspect of care and is gaining increasing importance as~     a measure of Healthcare quality. Tools for improving physician-patient communication are~     available but have not yet been tested in the Hospital setting. The purpose of this project~     is to determine if training in AIDET (Acknowledge, Introduce, Duration, Explanation, Thank)~     communication method improves physician-patient communication. Patient satisfaction data~     will be compared to historical controls using modified HCAHPS (Hospital Consumer Assessment~     of Health Plans Survey) as the primary outcome measure. In addition, a validation of~     delivery of AIDET communication will be accomplished through administration of~     questionnaires to patients.~   "
84803|NCT01947387|"~     This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin~     sheet bilayer or single layer products for complex soft tissue reconstruction of lower~     extremity diabetic wounds compared to other treatments. Participating sites will collect~     information for all patients who received Integra, free flap, local tissue flap, or negative~     pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index~     procedure, with index procedure being defined as the application of Integra, free flap,~     local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible~     for inclusion.~   "
84804|NCT01947374|"~     This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte~     implantation procedure compared to the microfracture procedure in the repair of symptomatic~     cartilage lesions of the knee. Eligible patients were asked for informed consent~     preoperatively and randomised for chondrocyte implantation of microfractures. Those patients~     allocated to the chondrocyte implantation group will be harvested at time of first~     arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament~     reconstruction, or malalignment corrected. The patients allocated to microfracture will be~     treated at the time of the only arthroscopic procedure. Both groups will have the same~     rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging~     will be performed as main outcomes.~   "
84805|NCT01947361|"~     Study of heterogeneity in associations between heart rate and the initial presentation of 12~     cardiovascular diseases.~   "
84808|NCT01947322|"~     Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The~     proposed study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of~     HLA-I mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells~     will be selected from HLA mismatch familial donor peripheral mononuclear cells by~     purification protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.~   "
84809|NCT01947309|"~     The primary objective of this study is to document efficacy and safety data in a real-world~     setting of Chinese multiple myeloma patients who have received at least one prior therapy~     treated with REVLIMID (lenalidomide).~   "
84810|NCT01947296|"~     The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term~     of early or unforeseen recourse to the hospital for adverse events.~   "
84811|NCT01947283|"~     The purpose of this study is to learn more about how patients and healthcare providers~     interact in order to improve shared decision making. The investigators plan to test an~     intervention with two separate educational components—one for patients and one for~     providers—designed to encourage patients to ask questions and increase their level of~     involvement in their own care, while simultaneously training providers to be more receptive~     to patients' questions and concerns. Patients in the intervention group will receive three~     short (30-45 minute) trainings focused on developing and asking questions and will be~     interviewed three times over the course of the intervention to see how it has affected the~     quality of their care. Providers receiving the intervention will participate in three~     separate trainings, including a 12-hour group workshop, an additional two hour training, and~     six hours of individual instruction, including personalized feedback based on three~     audio-recorded patient visits. Previous studies looking at patient engagement and~     involvement in decision-making have shown that increased engagement is linked with improved~     outcomes, but that providers are sometimes not prepared to develop a collaborative~     relationship with patients. The investigators think that training both patients and~     providers to work together and communicate more effectively will improve quality of care and~     increase patient satisfaction more than interventions that focus on only one side of the~     clinical encounter. One of the major goals in studying patient-provider communication is to~     improve shared decision-making and see how it contributes to racial and ethnic disparities~     in mental health care, since minority patients have been shown to be less involved in care~     and have been shown to be perceived and treated differently by providers.~   "
84812|NCT01947270|"~     Drug prescription is a fundamental component of care for the elderly. Even if drugs are a~     chance for the older patient, because of changes in pharmacological, pharmacokinetic and~     pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks~     associated with drug prescription, particularly those associated with potentially~     inappropriate medication (PIM), are increased in the elderly.~      We suppose that many of hospitalized elderly have at least one prescribed medication without~     valid indication. Conversely, many diseases are currently undertreated in elderly patients:~     e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of~     patients. Moreover, PMI prescription is associated with an increased of morbidity,~     mortality, risk of drug-related adverse events, utilization of health care system, care~     costs and impairment of quality of life. Thus, optimization of drug prescription is a major~     concern for improvement of the quality and safety of care in elderly.~      The investigators' hypothesis is that a multidisciplinary program entitled Optimisation de~     la Prescription MEDicamenteuse (Optimization of drug prescribing) focused on drug~     prescription optimization including a physician training to the specificity of the drug~     prescription in the elderly and a checklist allowing an adapted and standardized~     pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in~     short-term medical and geriatric care departments.~   "
84813|NCT01947257|"~     The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care~     to estimate right ventricular after load. The reference technique for this measure is the~     right catheterism which is an invasive technique. It is possible to estimate the pulmonary~     artery pressure by using transthoracic echocardiography (TTE) which allows, using the~     continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The~     measure of the TRvmax can however be difficult for intensive care patients with little~     echogenicity or impossible for those having no tricuspid leak. The evaluation of the~     tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks,~     one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE.~     However, the data of the literature are controversial on this method and it was not~     validated in mechanically ventilated intensive care patients.~      The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX~     (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP~     by transesophageal ultrasound and the direct measure of the pulmonary pressures by right~     catheterization, in ventilated patients already monitored with a catheter in the right~     cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the~     correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism~     which serves as reference technique.~   "
84814|NCT01947244|"~     The purpose of this randomized controlled trial is to examine whether evidence-based home~     visiting programs enhanced by doula services have effects on positive parenting practices,~     breastfeeding, and child and maternal health outcomes.~   "
84815|NCT01947231|"~     Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will~     be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR)~     with standard manual physical therapy on with respect to pain, function, kinesiophobia,~     range of motion, perceived effect, and satisfaction.~   "
84854|NCT01946724|"~     The purpose of this study is to study whether percutaneous chronic total occlusion (CTO)~     revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting,~     guidewire, and catheter, improves a patient's quality of life and their left ventricular~     function, reduces angina severity, and improves long-term survival.~   "
84855|NCT01946711|"~     The study should create data for the selection of a clinically relevant primary endpoint to~     assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the~     therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the~     selected parameter should allow a correlation between an objective methodology and the~     clinical outcome of the study patients.~   "
84816|NCT01947218|"~     Asthma and COPD are characterized by an accelerated decline in lung function associated with~     incompletely reversible airflow obstruction. This could be the result of lung structural~     changes and inflammation. Tissue repairing mechanisms may result in a restitution ad~     integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma,~     the remodeling is characterized by mucus cells hyperplasia, overproduction of mucus, and~     physicochemical, biological and immunological changes. Clinically, this mucus overproduction~     is reported by patients as the clinical symptom called chronic bronchitis. Generally, it~     develops at a bronchiolar level where it is responsible for the progression of these~     diseases. There is a paradox, because the intrinsic properties of mucus seem rather~     beneficial so fighting against it may not be really wise at long-term. Especially its~     defensive effect against microbial agents which remains poorly explained. Currently, no~     treatment aims to reduce the production of mucus and mechanisms leading to such an~     overproduction are poorly understood in severe asthma and COPD. The identification of new~     targets to treat this overproduction of mucus in COPD is therefore of major interest.~      In view of current knowledge, inflammatory mediators and signal transduction leading to~     increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL~     -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling~     pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2~   "
84817|NCT01947205|"~     Aim of the study was to investigate the analgesic efficacy of preoperative oral~     dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block~     with ultracaine on curettage procedure.~   "
84818|NCT01947192|"~     This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in~     etched dentin on the retention of noncarious cervical lesions restorations.~      A randomized controlled split-mouth and blind trial will be carried out. Patients with at~     least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned~     according the type of teeth (incisors, canine or pre-molars) into two groups: control or~     experimental group (application of 2% CRX for 60 seconds after the acid etching procedure).~     Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper~     Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture~     instructions, by previously trained operators. The restorations will be evaluated by a~     calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World~     Dental Federation (FDI) criteria. The outcome is retention of the restoration.~   "
84819|NCT01947179|"~     The purpose of this study is to test the effectiveness and usability of a computer-based~     treatment for mood and anxiety relevant risk factors. The target of the treatment is related~     to cognitive stress, which has been shown to be associated with several negative mental~     health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic~     Stress Disorder.~   "
84820|NCT01947166|"~     The Whipple procedure is associated with increased readmission rates for infection,~     pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop~     an evidence based perioperative nutrition plan to improve patient outcomes. The study has~     two specific aims including evaluation of feasibility of implementing an evidence based~     perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a~     standard perioperative nutritional plan on primary outcome of readmission rate and secondary~     outcomes of readmission cause, length of stay for initial hospitalization and/or~     readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis,~     delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores,~     BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including~     readmission rate, readmission cause, post-surgical complications and nutritional status will~     be compared by chi-square test between intervention and control group. Length of stay for~     initial hospitalization and readmission will be compared by non parametric Wilcoxon test~     between two groups. Descriptive statistics will be used to describe the sample. There are no~     risks to the study participants.~   "
84821|NCT01947153|"~     The objective of the current study is to demonstrate bioequivalence of two 2.5 mg~     linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination~     of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.~   "
84822|NCT01947140|"~     This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate~     are in patients with lymphoid malignancies and to determine the dose of the combination of~     drugs that is safest. If the combination is determined to be safe, the study will continue~     accrual patients with peripheral T-Cell lymphoma (PTCL).~   "
84823|NCT01947127|"~     To investigate the role of initial venous lactate in predicting the severity progression to~     overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock~     who suspected to have acute infections.~   "
84824|NCT01947114|"~     Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to~     remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.~      Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy~     were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started~     and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group~     K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil~     infusion 1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy~     remifentanil 0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters,~     emergence characteristics and adverse events were evaluated.~   "
84856|NCT01946698|"~     To investigate parameters related to fertility in women with endometriosis in relation to~     food items.~   "
84857|NCT01946685|"~     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left~     untreated or under-treated, it can become a chronic condition associated with significant~     distress, depression, aggression, family disruption, and substance abuse. There is also~     accumulating evidence that combat-related PTSD is associated with an increased risk of~     morbidity and mortality. For the welfare of returning veterans with PTSD and their families,~     it is critical that this disorder is promptly identified and effectively treated.~     Considerable advances that have been made in the assessment and treatment of PTSD in recent~     years; however, psychopharmacological treatments have been shown to be largely ineffective~     for veterans with PTSD.~      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -~     pharmacological manipulation of the body's major stress system (the~     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is~     a glucocorticoid receptor (GR) antagonist with peripheral and central nervous system~     effects, making it a compound of interest in the treatment of stress related disorders.~     There is abundant evidence of enhanced GR sensitivity in veterans with PTSD which is thought~     to underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.~     Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and~     lead to clinically meaningful improvement in symptoms and cognition. There is preliminary~     evidence that short-term mifepristone treatment has sustained beneficial effects on mood,~     cognition and sleep disturbance in some neuropsychiatric conditions (major depression,~     bipolar disorder, primary insomnia). That there can be sustained clinical and~     neuropsychological effects of mifepristone and normalization of basal HPA axis activity~     after drug discontinuation in these disorders, has led to the view that mifepristone's~     actions include recalibration of a dysregulated HPA axis. Accordingly, we propose to study~     the effects of mifepristone in veterans with chronic PTSD to determine if it is efficacious~     in improving PTSD symptoms and associated clinical outcomes. To better understand the~     mechanism of action of mifepristone we propose to assess the effects of mifepristone on HPA~     axis activity and their relationship to treatment outcome and clinical response.~      To achieve these objectives, we propose to conduct a Phase IIa, multi-site, double-blind,~     placebo controlled trial of mifepristone in veteran outpatients with military-related PTSD~     through the VA's Cooperative Clinical Trial Award program. We propose to enroll 136~     unmedicated male veterans with military related PTSD at four VA sites (Albuquerque, NM,~     Bronx, NY, Durham, NC, and San Diego, CA). Eligible veterans will be randomly assigned in~     parallel groups to treatment with 600 mg/day mifepristone or placebo for one week and~     followed for up to three months. Using statistical selection theory, we propose to determine~     whether 600 mg of mifepristone yields a sufficiently high proportion of clinical responders~     after one month to warrant more extensive and definitive research as part of a Phase III~     trial. Secondarily, we seek to determine the effect of the dose of mifepristone compared to~     placebo on the trajectory of CAPS scores and the time to addition of rescue medication, as~     well as compare rates of adverse events and serious adverse events across the three groups.~     We will also describe the effects of mifepristone on several other clinical parameters~     including PTSD symptomology, depression severity, sleep quality, and functional impairment.~     Several measures of neuroendocrine functioning will also be obtained to explore the~     relationship of plasma cortisol and ACTH levels to clinical response and the time to~     addition of rescue medications.~   "
84858|NCT01946672|"~     The purpose of this study is to evaluate the feasibility of an isotopic technique to~     identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for~     gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we~     will determine the incidence of lymhedema.~   "
84961|NCT01945333|"~     The purpose of this study is to develop and pilot test personalized and scalable approaches~     to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is~     to more clearly define the therapeutic targets important to the facilitation of cognitive~     and functional improvement so that clinicians know how to customize cognitive interventions~     and deliver treatment in a more effective, efficient and personally relevant manner.~   "
84825|NCT01947101|"~     Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel~     disease, will be invited to take part in this study. The investigators do not know what~     causes UC. However, the microbes (such as bacteria and viruses), which normally live in our~     intestines are thought to play an important role in the development of UC. There are many~     treatment options for UC such as steroids,and other medications that decrease inflammation.~     However, none of these can cure the disease.~      This study aims to treat pediatric UC in an alternative fashion by changing the microbes in~     the gut by giving the participant's stool specimens from healthy adult individuals. There is~     some evidence from a few cases of adult UC that this therapy may cure the disease or at~     least provide long lasting suppression (remission) of the symptoms. The investigators would~     like to test this therapeutic intervention in children with UC.~      The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to~     determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3)~     The investigators will also study the effects of the treatment on colonic gene expression.~   "
84826|NCT01947088|"~     Participation in music therapy will result in improvement in cognitive functioning, as~     measured by neuropsychological testing 9-12 months following surgery.~   "
84827|NCT01947075|"~     Following the decline of malaria in Sub-Saharan Africa, clinicians face febrile patients in~     whom an alternative diagnosis has to be made. This situation has led to an overuse of~     antibiotics by clinicians. It is crucial to increase knowledge on etiologies and risk~     factors of outpatient febrile illness in order to improve their management.~      This present proposal aims to investigate the etiologies of fever among adult patients~     attending an outpatient department in urban Tanzania. It also aims to assess the clinical~     significance of nasopharyngeal (NP) respiratory viruses and bacteria documentation in this~     setting. Third, it aims to compare the spectrum of infections in this population with that~     of children included in the same setting in a previous study. The last objective is to~     assess diabetes mellitus (DM) as a risk factor for infection and exposure to indoor air~     pollution (IAP) as a risk factor for acute respiratory infections (ARI) in adults in~     Tanzania.~      The investigators hypothesize that acute respiratory infections are the main cause of adult~     febrile illness in a urban low-income setting and that use of quantitative molecular assays~     on naso-oropharyngeal samples can improve the diagnosis of pneumonia. The investigators also~     think that the spectrum of infections is different between children and adults, mainly due~     to a high HIV prevalence in adults. The investigators also hypothesize that experiencing IAP~     and/ or DM is a risk factor for infections in adults.~   "
84828|NCT01947062|"~     Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves~     the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as~     cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered~     intravenously in the standard three-weekly intervals.~      Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial~     effects in delaying disease progression among heavily pre-treated patients with various~     malignancies.~      This study attempts to combine the use of metronomic chemotherapy concurrently during~     standard intravenous chemotherapy.~   "
84829|NCT01947049|"~     The purpose of this study is to:~        1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza~          test, Xpert Flu.~        2. Derive and validate an adult clinical decision guideline to guide clinical testing of~          influenza patients who meed CDC criteria for antiviral treatment.~        3. Evaluate impact of rapid influenza testing for antiviral treatment.~        4. Determine cost effectiveness of influenza testing and treatment strategies.~   "
84830|NCT01947036|"~     The study aims to establish whether defects in immune cell function are shared across~     multiple autoimmune diseases and whether those problems match to similar genes in the cells.~   "
84831|NCT01947023|"~     This phase I trial studies the side effects and best dose of lapatinib ditosylate when given~     together with dabrafenib in treating patients with thyroid cancer that cannot be removed by~     surgery and has not responded to previous treatment. Dabrafenib and lapatinib ditosylate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
84832|NCT01947010|"~     Inflammatory bowel disease (IBD) are at increased risk of infections. This increased~     susceptibility to infections is due to the disease itself, but also be-cause many patients~     with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine~     and or TNF-a inhibitors.~      Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and~     one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus~     can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23~     valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal~     vaccines (PCV13).~      In this study the investigators wish to study the effect of pneumococcal vaccination with~     either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or~     untreated.~   "
84833|NCT01946997|"~     The purpose of this study is to evaluate topographic features of the posterior pole of the~     eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic~     retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a~     novel study to determine retinal volume of normal and diabetic subjects without DR.~     Specifically, the investigators will establish a standardized reference range for retinal~     thickness and volume that will provide standards for OCT analysis of different clinical~     trials for retinal diseases.~   "
84834|NCT01946984|"~     1. The most common complication of endoscopic retrograde cholangio-pancreaticography~          (ERCP) is pancreatitis.~        2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent~          the post ERCP pancreatitis, the investigators used diclofenac vs placebo.~        3. The effect of diclofenac in prevention of that complication, was measured by the number~          of patients who developed pancreatitis, and compare it with the placebo.~        4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of~          them underwent the intervention called ERCP, and randomized to have either Diclofenac~          or Placebo before the procedure.~   "
84835|NCT01946971|"~     This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm~     infants with gastroesophageal reflux.~   "
85003|NCT01944787|"~     The hypothesis of the present study is the hydration of nulliparous women with 250ml/hour~     vs. 125ml/hrs would decrease the rate of primary cesarean section.~   "
84836|NCT01946958|"~     The objective of this study is to conduct a randomized control trial to evaluate the impact~     of Triple P on the clinic practice of pediatric residents and on select parent and child~     outcomes. This study will accomplish that overarching goal through addressing two specific~     aims.~      Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P~     training on practice of pediatric residents in addressing and managing psychosocial~     problems.~      Hypothesis 1: At the completion of the trial, residents assigned to the intervention group,~     compared to residents exposed to the control condition, will have:~        1. increased skill levels,~        2. increased confidence, and~        3. increased satisfaction in dealing with and managing psychosocial issues~      Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P~     interventions on parent's feelings of self efficacy, parent's discipline strategies and on~     children's externalizing behavior.~      Hypothesis 2: At the completion of the intervention, parents and children receiving the~     intervention, compared to those receiving the control condition, will have:~        1. greater reduction in targeted child behavior problems,~        2. greater reduction in dysfunctional parenting practices,~        3. increased use of appropriate discipline and positive parenting strategies, and~        4. greater confidence in parenting ability.~   "
84837|NCT01946945|"~     We propose to perform a clinical randomized trial to evaluate the effect of blastocyst~     biopsy and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to~     standard Assisted Reproductive Technologies (ART) methods on on implantation rates,~     miscarriage rates, and pregnancy rates.~      This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b)~     a non-selection study based on the control group for which we will replace without knowing~     the ploidy of the embryos, but we will know it later, c) a retrospective study about the use~     of Mitochondrial DNA as a selection tool.~   "
84838|NCT01946932|"~     This is a steering group approved substudy to the Target Temperature Management trial (TTM,~     ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly~     controlled temperature regimes for survivors of out-of-hospital cardiac arrest.~      The primary aim of this sub-study is to compare the amount of cognitive impairment in~     cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of~     control patients with myocardial infarction.~      Our secondary aims are:~        -  To investigate the impact of cognitive impairment on our patients' ability to~          participate in society and their health related quality of life.~        -  To investigate the relationship between our patients cognitive impairments and their~          relatives/informants health related quality of life and feelings of burden.~        -  To test the hypothesis that the simple cognitive screening battery used in the TTM main~          trial is sensitive enough to detect all patients with significant cognitive disability.~   "
84839|NCT01946919|"~     Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety~     of the cinepazide, especially the blood system, has not been fully evaluated in Chinese~     population. In order to improve the rational use of cinepazide, the investigators observe~     its clinical use in the real world in China, evaluate its safety and clinical benefit in a~     large Chinese population.~   "
84840|NCT01946906|"~     Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and~     auto inflammatory disorders. The study will investigate if intervention with Rifaximin~     modifies the gut microbiota with a subsequent alteration in markers of systemic immune~     activation and inflammation in patients with CVID. The investigators hypothesize that the~     gut microbiota of CVID patients, at least partly through interaction with the innate immune~     system within the intestine, contribute to a low-grade systemic inflammation in these~     patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates~     systemic inflammation through modulation of the gut microbiota. The study may lead to~     increased understanding of the interaction between microbiota and the immune system. The~     study could give new insight into important disease processes in relation to the interaction~     between the microbiota, the intestine and the systemic compartment, and potentially be the~     basis of new therapeutic strategies in these patients to prevent and down-regulate the~     auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of~     relevance for other disorders where the interaction between microbiota and intestinal and~     systemic inflammation is involved such as various cardiovascular and metabolic disorders.~      The investigators hypothesize that the gut microbiota of CVID patients, at least partly~     through interaction with the innate immune system within the intestine, contribute to a~     low-grade systemic inflammation in these patients, and that an intervention with the~     non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of~     the gut microbiota.~   "
84841|NCT01946893|"~     The purpose of this pilot study is to collect feasibility and acceptability of an internet~     mindfulness meditation intervention for older adults and to collect preliminary data on mood~     and cognition changes from before to after the intervention. Up to 32 older adults will be~     randomized to receive a mindfulness meditation intervention or a time and attention control,~     both delivered over the internet (16 completers). Participants will have a one-hour session~     weekly for six weeks with daily home practice between sessions. Participants will complete~     the sessions online with a study iPad. Their home practice will also be installed on the~     study iPad as well as an objective adherence monitoring program that the investigators~     developed to track actual home practice between sessions. The feasibility and acceptability~     measures are enrollment rate, completion rate, and participant satisfaction. Self-report~     mood questionnaires and cognitive tasks will be measured before and after the intervention~     period and data used to conduct power analyses and sample size estimation for a larger~     clinical trial.~   "
84842|NCT01946880|"~     This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on~     risk of clinically significant disease reactivation in quiescent SLE patients who have been~     on long-term MMF therapy.~   "
84899|NCT01946139|"~     This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell~     changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may~     help doctors find cancer cells early and plan better treatment for anal cancer. Completing~     multiple screening tests may help find the best method for detecting cell changes in the~     anus.~   "
84900|NCT01946126|"~     This study is a retrospective chart review in patients diagnosed with headache or migraine~     to evaluate treatment patterns and diagnosis.~   "
84843|NCT01946867|"~     RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the~     western world. The oropharynx is the posterior continuation of the oral cavity and connects~     with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of~     primary head and neck cancers. These structures play a crucial role in swallowing, breath~     and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate~     muscles or nerves, which significantly disturb local functions. The incidence of Head and~     Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this~     population as recorded by the Surveillance, Epidemiology, and End Results registries in the~     United States. Regarding the therapeutic strategies, the association of radiotherapy with~     chemotherapy or biologics has demonstrated significant improvement of outcomes with the~     drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival~     improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell~     killing and complete tumor shrinkage allowing a definitive treatment and preservation of~     local structures and functions in patients older 65 years, who cannot receive cisplatin.~   "
84844|NCT01946854|"~     Appendiceal cancer is a rare disease that does not cause many symptoms. As such, doctors are~     not sure if chemotherapy actually has an effect on the disease. The goal of this clinical~     research study is to learn more about the effects that chemotherapy may have on appendiceal~     cancer.~   "
84845|NCT01946841|"~     The objective of this unblinded study is to assess the nutritional effects of a 12 weeks~     administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as~     the impact on the patients' quality of life.~   "
84846|NCT01946828|"~     The objective of this clinical trial is to evaluate the FIM optimal configuration and~     confirm the safety and performance/efficacy of the FIM when exposed to a larger and more~     varied population of users.~   "
84847|NCT01946815|"~     Natural course of intermediate coronary artery disease (CAD) is very important to predict~     the prognosis of the patient with such disease.~      Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on~     the progression of CAD with the modification of lipid profiles.~      This effect can be also explained by intravascular ultrasound (IVUS) or optical coherence~     tomography. However, the effect of plaque modification on coronary physiology has been~     rarely evaluated.~      This research is to evaluate the change of intermediate or nonculprit coronary lesion on~     lipid-lowering therapy via IVUS(optional) and FFR.~   "
84848|NCT01946802|"~     Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid~     shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is~     difficult to detect seizure and the frequent or continuous EEG monitoring is recommended.~     However, it is difficult to follow this recommendation in most clinical situations due to~     the lack of specialized devices and persons. The purpose of this study is whether SEDline~     (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic~     hypothermia in cardiac arrest victims.~   "
84849|NCT01946789|"~     The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of~     ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell,~     non-small cell lung and squamous cell head and neck cancer~   "
84850|NCT01946776|"~     Patients with difficult-to-treat epilepsy (refractory epilepsy) are at high risk of sudden~     death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the~     possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac~     arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable~     device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of~     time, the frequency of clinically relevant arrhythmias appeared much higher in two small~     observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and~     underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory~     epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients~     at high risk of cardiac arrhythmias, so that we can timely institute preventive measures~     (e.g. pacemaker implantation).~   "
84851|NCT01946763|"~     The recovery and emergences from anesthesia is a critical phase. Previous studies focused on~     pharmological and anesthetics techniques to improve the quality of this stage (duration,~     complications).~      In this study, our first aim is to test the impact of pre operative education on the post~     operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.~   "
84852|NCT01946750|"~     Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be~     predict the Clostridium difficile infection.~      This study evaluates the weight of immunity by studying patients with Clostridium difficile~     infection versus controls (each patient is associated with two controls : diarrheal control~     without Clostridium difficile, and non-diarrheal control with or without Clostridium~     difficile). Recurrence and the kinetics of immune response following infection Clostridium~     difficile are studied by following the patients during three months.~      There are also building biological samples collections clinically documented: sera, stool~     and strains.~   "
84853|NCT01946737|"~     CT technology is evolving at a rapid pace, with introduction of multidetector row CT~     scanners (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of~     heart scans CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to~     conventional invasive coronary angiography (ICA), which is considered the gold standard in~     the investigation of coronary disease. There has been a gradual increase in the utilization~     of CTCA for primary assessment of low and intermediate risk patients. However concerns~     regarding radiation exposure and diagnostic accuracy, especially in the highrisk group, have~     prevented its widespread dissemination.~      To achieve best possible temporal resolution (minimize cardiac motion artifacts) and spatial~     resolution (provide diagnostic accuracy) relatively high radiation exposure is required, as~     a result of its inverse relationship with image noise and resolution. However radiation~     (X-ray) is associated with increased risk of cancer in exposed patients and it is therefore~     essential to continually devise strategies to reduce radiation exposure whilst maintaining~     image quality.~      A state-of-art CT scanner (Discovery CT750 HD, General Electric (GE) Healthcare), has been~     installed at Derriford hospital for further research on CTCA. It uses novel method of~     scanning, High Definition Computed Tomographic Coronary Angiography(HD-CTCA), analogous to~     high definition television) and image reconstruction (Adaptive Statistical Iterative~     Reconstruction ASIR)as opposed to conventional CT scanners using Filtered Back Projection~     (FBP)reconstruction. HD-CTCA enables acquisition of sharper images and ASIR offsets the~     resultant increase in radiation exposure. This is likely to result in images of higher~     diagnostic quality with an equivalent or slightly lower radiation exposure compared to~     present technology. Although initial results are encouraging, this needs further assessment~     before being applied to routine clinical practice. To assess this we have designed a study~     to perform HD-CTCA on 300 consecutive patients undergoing diagnostic ICA at Derriford~     hospital, directly comparing the accuracy of HD-CTCA to ICA (presently considered the gold~     standard).~      Hypotheses:~      There is no significant difference in the sensitivity and specificity of HD-CTCA for the~     detection of coronary artery stenosis of 50% or greater compared to conventional ICA.~   "
84859|NCT01946659|"~     This is a randomized controlled Trial to evaluate effect of a culturally and linguistically~     tailored, telephone-delivered behavioral intervention on adherence to recommended assessment~     and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe~     low awareness of Sleep Apnea and the risk it imposes to an individual health plays an~     important role in underdiagnosis and low adherence to treatment among Blacks. Hence,~     culturally and linguistically tailored health education will decrease the knowledge gap and~     improve adherence to recommended assessment and treatment of sleep Apnea. the investigators~     believe the effect of adherence to treatment of Sleep apnea is shown to improve the~     components of Metabolic syndrome and hence promote well control of Hypertension, Diabetes,~     weight, triglyceride and cholesterol.~   "
84860|NCT01946646|"~     The purpose of this study is to determine whether combination of TS-1 and concurrent and~     short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this~     study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential~     of local control of concurrent chemoradiotherapy in pancreatic cancer.~   "
84861|NCT01946633|"~     The present study is a feasibility study to assess the safety and efficacy of wireless~     capsule endoscope and compare the data obtained with those obtained by using a conventional~     esophagogastroduodenoscopy.~      The product was developed and manufacture in China.(the NaviCam. AKC-1.China)~   "
84862|NCT01946620|"~     Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.~   "
84863|NCT01946607|"~     Neuroticism is a personality trait described as an enduring tendency to experience negative~     emotional states and to respond poorly to environmental stress. It has been shown that high~     neuroticism can predispose, amongst other factors, to the development of depressive~     episodes. Recent studies suggest that subjects with high neuroticism have a different~     response to stimuli with an emotional content, showing both decreased processing of positive~     or increased processing of negative emotionally salient cues. These differences in cognitive~     processing of emotional stimuli are believed to underpin the psychological characteristics~     that link high neuroticism with a higher risk for depression.~      Preliminary data also indicate that modulation of serotonin function by antidepressant~     treatment in healthy volunteers with high neuroticism traits could modify the brain activity~     associated with the processing of emotional stimuli that is dysfunctional in this vulnerable~     population.~      The aim of this research is to investigate further whether modulation of serotonin function~     via administration of serotonergic antidepressants (SSRIs) can revert the dysfunctional~     emotion processing that characterises subjects with the personality trait of high~     neuroticism.~      In particular we hypothesise that SSRI administration will modify the abnormal patterns in~     attention, physiological reactivity and regulation of emotional stimuli present in healthy~     individuals with the vulnerable personality trait of high neuroticism.~      Carrying out this research on healthy volunteers will enable us to understand if modulating~     serotonin function by antidepressant administration has an effect not only on mood symptoms~     - as is evident in depressed patients - but also on the predisposing psychological and~     cognitive processes that sustain the depressed mood, such as the response to emotional~     stimuli. We will also be able to verify if this effect is shown early treatment and prior to~     any subjective changes in mood. This will be done by administering seven days of either the~     antidepressant citalopram or placebo to subjects with high neuroticism scores and then~     comparing them on a series of computer based psychological tests measuring various aspects~     of how emotionally salient stimuli are processed.~   "
84864|NCT01946594|"~     The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the~     effect of prophylactic antipyretics on the immune responses and rates of fever after~     inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot,~     40 healthy children, 12 through 35 months of age, including some children at risk of febrile~     seizure, will be randomized to receive prophylactic acetaminophen or oral placebo~     immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV.~     Data derived from the pilot study will be used to assess the feasibility of conducting a~     larger scale study. Feasibility will include assessments of the speed and ease of study~     recruitment and adherence to and completion of study assessments. Children will be followed~     for the occurrence of fever, fussiness, changes in appetite and sleep patterns, and use of~     medical services on the day of and day following vaccination. Antibody to influenza antigens~     contained in the 2013-2014 vaccine as measured by hemagglutination inhibition (HAI) antibody~     will be assessed at baseline and four weeks following vaccination. The proportions of~     children experiencing fever, having solicited reactions, using medical services,~     demonstrating a serologic response corresponding to seroprotection and seroconversion to~     each of the IIV antigens will be determined for groups of children receiving acetaminophen~     and placebo. Likewise geometric mean HAI titers (GMT) and corresponding 95% confidence~     intervals for each IIV antigen will be calculated for both vaccine groups.~   "
84865|NCT01946581|"~     Define what factors correlate with higher degrees of patient satisfaction and~     dissatisfaction among patients who have recently undergone cataract surgery.~   "
84866|NCT01946568|"~     A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients~     aged 3 months to 11 years (inclusive) following the intravenous administration of a single~     dose of dalbavancin.~   "
84867|NCT01946555|"~     The BTP (Breakthrough pain)was defined as a transient exacerbation of pain that occurs~     either spontaneously, or in relation to a specific predictable or unpredictable trigger,~     despite relatively stable and adequately controlled background pain.~      The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough~     cancer pain). The prevalence of BTcP is equal to 56%.~      Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP~     in the three sub-types: voluntary, non- voluntary and procedural.~      The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe~     changes in the intensity of pain during the day, so it is necessary to differentiate slight~     fluctuations from the presence of real episodes of BTCP, for which is necessary to use a~     rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm,~     present in the literature, to perform the diagnosis of BTCP.~      In the presence of BTCP, is important both a correct controlled background pain with major~     opioids, which can reduce the number and the intensity of the painful episodes, both~     implement an adjunctive therapy, called rescue, to be administered at the time which takes~     over the painful episode using, in this case, an opioid greater.~   "
84868|NCT01946542|"~     The purpose of this project will be to determine whether consumption of beet juice~     concentrate prior to exercise may acutely improve exercise tolerance in patients with heart~     failure.~   "
84901|NCT01946113|"~     Acute renal failure is a common complication in intensive care unit patients. In 10% of~     cases renal replacement therapy becomes necessary. Current devices have increase filter~     patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well.~     However, the extend of this elimination hase not been quantified. Thus, we want to~        1. record retrospectively how often abnormal values for phosphate, magnesium and calcium~          occurred during routine renal replacement therapy in 2011 and 2012.~        2. prospectively evaluate the same parameters during routine treatment in 2013 and 2014~   "
84869|NCT01946529|"~     This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and~     desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two~     treatment groups, A or B, based on tumor characteristics.~      Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to~     other parts of the body, and are less than 14 years of age. Because previous clinical trials~     have shown that standard treatment is very effective for children whose tumors have these~     characteristics, these participants will receive standard treatment.~      Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis,~     or the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen~     and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other~     parts of the body will be included in Group B. Participants in this group are considered~     high risk because there is a greater chance of tumor recurring following standard treatments~     currently in use.~      All participants will be followed and evaluated for 10 years following completion of~     therapy.~   "
84870|NCT01946516|"~     The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C~     infection among newly diagnosed cancer patients presenting to community and academic~     oncology clinics.~   "
84871|NCT01946503|"~     The purpose of this study is to better understand why children with short gut develop~     feeding problems.~   "
84872|NCT01946490|"~     A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery~     of very high radiation doses is needed to obtain local control, but due to the large tumor~     and nodal volume this is often impossible without causing unrepairable damage to the normal~     tissue of the mediastinum, spinal cord, esophagus and lung.~      Although every tumor is different with respect to the speed with which it grows and spreads,~     it is obvious that time plays an important role in cancer therapy. Recently it was reported~     that disease progression or increase of tumor volume occurred during the time interval~     between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment~     and consequently have an impact on overall survival. Moreover, the increasing number of~     diagnostic procedures, aimed at obtaining more accurate information about the tumor~     extension and biology, as well as the use of more sophisticated but labor intense radiation~     techniques could prolong the time interval between clinical symptoms and the start of the~     treatment. However, the influence of new diagnostic procedures or the applied radiotherapy~     techniques on waiting times is not yet known. The investigators therefore want to~     investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation~     between waiting times and the use of more advanced diagnostic or therapeutic procedures, and~     3) the correlation between waiting times and overall survival.~      The hypotheses of the study:~        1. The diagnostic delay for NSCLC patients has increased during the last 12 years.~        2. The preparation time for radiotherapy of NSCLC patients has increased during the last~          12 years.~        3. Prolonged waiting times are associated with worse overall survival outcome.~   "
84873|NCT01946477|"~     This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and~     low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) ,~     daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed~     or refractory multiple myeloma who have received a first or second line treatment of~     lenalidomide-based therapy.~      This trial will test the hypothesis for Cohort A that the proportion of patients will have~     an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in~     pretreated patients who are refractory to lenalidomide.~      This trial will test the hypothesis for Cohort B that the proportion of patients will have~     an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in~     pretreated patients who are refractory to lenalidomide.~   "
84874|NCT01946464|"~     This study is being done to see if we can improve the way we manage patients' airways. In~     some instances patients who have a beard, who do not have teeth or have breathing problems~     during sleep present a challenge to the anesthesiologist. In such patients, it is sometimes~     difficult to provide air/oxygen for breathing using a mask. The study doctors would like to~     investigate a new method for holding a mask on the face of those patients. They are~     interested in comparing a new method against two older methods. They believe the new method~     will deliver a larger amount of air to the lungs. This information may help doctors provide~     better care for patients who have beards, no teeth, or breathing problems during sleep.~   "
84875|NCT01946451|"~     The purpose of this study was to investigate the expression of selected genes both in~     epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients~     with primary and secondary epiretinal membranes in proliferative diabetic retinopathy.~     Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were~     also identified.~   "
84876|NCT01946438|"~     The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and~     Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety~     and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65~     years of age.~      Primary Objective:~        -  To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and~          Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the~          2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults~          ≥ 65 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent~          and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the~          immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone~          High-Dose vaccines in adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone~          Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group~          with the historical requirements of the Committee for Human Medicinal Products (CHMP)~          Note for Guidance (NfG) CPMP/BWP/214/96.~        -  To submit sera from selected subjects to the Center for Biologics Evaluation and~          Research (CBER) for further analysis by the World Health Organization (WHO), the~          Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration~          (FDA) to support formulation recommendations for subsequent influenza vaccines.~   "
84902|NCT01946100|"~     To gather preliminary safety and outcome data for the multimodality treatment of lung~     adenocarcinoma in the setting of multifocal BAC.~   "
84877|NCT01946425|"~     The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent~     vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata~     (6 months to < 36 months and 3 years to < 9 years)~      Primary Objective:~        -  To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on~          Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of~          age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER)~          for further analysis by the World Health Organization (WHO), the Centers for Disease~          Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support~          formulation recommendations for subsequent influenza vaccines.~   "
84878|NCT01946412|"~     The purpose of this study is to provide information regarding the long-term safety and~     pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of~     age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will~     further explore the efficacy of long-term ivacaftor treatment in this population of patients~     with CF.~   "
84879|NCT01946399|"~     To determine if Ozurdex implant can offer an effective treatment for macular edema~     associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis,~     or Eylea have not demonstrated a significant response.~   "
84880|NCT01946386|"~     The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with~     Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle,~     Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.~   "
84881|NCT01946373|"~     The purpose of this study is to learn if dendritic cell vaccine will increase the effect of~     tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with~     melanoma.~   "
84882|NCT01946360|"~     Blood will be collected after venepuncture from all patients for complete blood counts,~     Serum bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase,~     alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea,~     creatinine, sodium, potassium, serum total protein and albumin, within 24 hours after~     admission and twice a week there after or as and when needed.~      Time line for blood tests and evaluation of clinical parameters & 13C-MBT~      For ALF patients:~      On days 0, 1, 3, and 7~      For ACLF patients:~      On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)~      Blood tests would include:~      Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase,~     alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin),~     prothrombin time & international normalized ratio (INR), Serum urea and creatinine, serum~     electrolytes, arterial ammonia and arterial blood gas analysis.~   "
84883|NCT01946347|"~     The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes~     in plasma glucose and lipids concentrations on the endothelial function together with other~     metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.~      Hypothesis:~      Different changes in endothelial function to acute in vivo induced hyperinsulinemia and~     after the meal test will be found in patients with T2D compared to healthy subjects.~      A significant relationships between insulin sensitivity, selected adipokines~     intramyocellular fat content, hepatic fat content and high energy phosphates in soleus~     muscle will be documented in both groups.~   "
84884|NCT01946334|"~     The anorectal manometry is the gold standard in the evaluation of anorectal function.~      Several techniques are currently used (balloons, perfused catheters) and are always~     performed in the supine position.~      Few studies have reported the evaluation of sphincter function in the upright position,~     whereas symptoms of fecal incontinence occur in this position.~      Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows~     topographic analysis and evaluation of anorectal function more acurate. In addition, the~     rigid nature of the probe should allow stability measures / recording, which is not possible~     with probes perfused catheters example.~      We therefore propose to compare anal sphincter pressure in supine and standing, measured in~     high-resolution manometry.~   "
84885|NCT01946321|"~     During any period of rehabilitation it is important to select meaningful tests that; measure~     what you want, are responsive to changes in the patient's condition and, easy to use in the~     clinical settings. With an amputee such tests may help make sure that rehabilitation~     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New~     prosthetic technology is continually being developed and the active amputee now demands more~     from their artificial limbs. Making sure that they get the right rehabilitation programmes~     and the most appropriate prosthesis will help them perform to their best.~      Thirty amputees who have recently undergone a lower limb amputation will be recruited into~     this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure~     different aspects of their recovery from the comfort of the socket to their perceived~     ability to undertake everyday tasks. Each of the tests give a score or grade which~     represents the level of their ability, as judged by the test, at that given time point. The~     tests will be repeated at one and three weeks after delivery of their prosthesis, just~     before discharge from hospital and at 6 weeks post-discharge.~      By measuring the changes in the scores across these time points, and also how the amputees~     feel they have changed, it is hoped that it can be determined how responsive the tests are~     to objective measures of changes in the amputees abilities and also whether the tests are~     sensitive to the changes felt by the amputee. If it is shown we can more accurately link~     changes in the scores to the changes in the amputees abilities then Physiotherapy treatment~     programmes could be more accurately tailored to the individual amputee.~   "
84903|NCT01946087|"~     The aim of this study is to investigate whether RIPC protects the heart against ischemia~     reperfusion injury on the concentrically hypertrophied myocardium~   "
84904|NCT01946074|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical~     development plan for ABT-165 is based on the activity demonstrated in preclinical models.~   "
84886|NCT01946308|"~     Babies born too soon, premature babies, can have complications following birth because their~     systems are immature. Hospitals help prevent deformities and delays in motor development by~     using therapeutic positioning to provide containment as they would experience in the womb.~     They also often have trouble eating. They have discomfort, are irritable, refuse to eat and~     cry because their digestive system is immature. The neonatal intensive unit can create~     stress and disrupt their sleep. Going from active to deep sleep is essential for infant~     brain development, learning and memory formation. Their sleep states early in life predict~     their developmental outcome. The purpose is to determine whether a conformational~     positioning system, one that can mold to the baby and contain him or her, will allow more~     time asleep in premature infants with feeding problems compared to the standard crib~     mattress. We hypothesize that the number of total sleep time will be longer and the number~     of arousals out of sleep lower when they are sleeping on the conformational positioning~     system compared to the mattress.~   "
84887|NCT01946295|"~     Objective of the trial is to study if famotidine add-on treatment is more effective than~     placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient~     response to ongoing antipsychotic treatment.~   "
84888|NCT01946282|"~     Through this program, the investigators will test a systematic colon cancer screening~     outreach strategy for increasing screening completion among uninsured patients, not~     up-to-date with screening. The intervention will consist of mailed screening invitations,~     with processes such as phone reminders to promote screening and evidence based follow up.~     All patients will be randomly assigned to receive mailed invitations to complete a home~     fecal immunochemical test (FIT). Some patients will be randomly assigned to receive a small~     financial incentive on completion of FIT testing.~   "
84889|NCT01946269|"~     The purpose of this study is to determine whether a goal-directed resuscitation therapy~     within the first 8 hours after major abdominal cancer surgery reduces postoperative~     complications compared to a standard therapy.~   "
84890|NCT01946256|"~     PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH~     ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE~     COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS~     WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE~     SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION~     WILL ALSO BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH~     TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM.~     LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT~     ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB~     WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY~     PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL~     PACKAGE FOR SOCIAL SCIENCES VERSION 17.~   "
84891|NCT01946243|"~     The overall objective of the study is to assess the feasibility of implementing a~     quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use~     of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.~   "
84892|NCT01946230|"~     The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the~     reasons result in these situations is the patent visits hospital for treatment in late stage~     of oral cancer. Recently, the government makes effort in oral cancer screening to find oral~     potentially malignant disorders (OPMD) early. However, there is no conscience in treatment~     strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases~     to find out the potential biomarker, which is able to predict the oral cancer malignant~     transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD~     with no oral cancer malignant transformation will also be enrolled as the disease control~     group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will~     be collected. All those groups will detect the expression of p62/SQSTM1 to investigate the~     possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM,~     and a guideline to treat or not to treat OPMD.~   "
84893|NCT01946217|"~     This pilot research trial studies factors affecting patient participation in Acquired Immune~     Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials.~     Determining how patients makes decisions about participating in a clinical trial may help~     doctors plan clinical trials in which more patients are willing to participate and are~     satisfied with their decision to participate.~   "
84894|NCT01946204|"~     The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men~     with high-risk non-metastatic castration-resistant prostate cancer.~   "
84895|NCT01946191|"~     The purpose of this study is to test whether online tracking tools and weight maintenance~     coaching visits for patients and real-time electronic progress reports for primary care~     providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance~     than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients~     who have lost ≥ 5% of their body weight.~   "
84896|NCT01946178|"~     The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic~     focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to~     offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to~     assess the initial safety and performance of the Mirabilis HIFU Treatment System for~     transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo~     hysterectomy following treatment with the device or who are seeking relief from~     fibroid-related symptoms.~   "
84897|NCT01946165|"~     The goal of this clinical research study is to learn if adding the combination of~     abiraterone acetate and prednisone with or without enzalutamide to hormonal therapy can help~     to control prostate cancer when given before surgery. The safety of the drug combination~     will also be studied.~   "
84898|NCT01946152|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given in combination with dexamethasone and neupogen (filgrastim)~     to patients with relapsed or refractory MM.~      The goal of Part 2 of this study is to learn if the drug combination can help to control MM.~      The safety of this drug combination will be studied in both parts.~   "
85004|NCT01944774|"~     The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of~     Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with~     community-acquired pneumonia (CAP).~   "
84905|NCT01946061|"~     Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients~     could underwent curative surgery. In those, about 60% of patients would survive after 5~     years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC~     trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced~     gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was~     insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric~     cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant~     therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer~     patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer~     has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant~     chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric~     cancer patients.~   "
84906|NCT01946048|"~     The aim of the present study is to investigate safety and efficacy of intramyocardial~     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .~   "
84907|NCT01946035|"~     Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is~     known to seriously decrease quality of life, aggravate preexisting conditions particularly~     asthma, carry significant medical treatment costs and be responsible for reduced work~     productivity and lost school days. A significant symptom of the condition, nasal blockage,~     remains difficult to treat even when using nasal corticosteroids. Decongestant medications~     act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose~     but if used for more than seven days a more severe rebound congestion of the nose develops.~      In this study, the investigators aim to assess the effects of doxazosin, a drug which is~     currently used to treat high blood pressure and symptoms of prostate enlargement, to find~     out if it has an effect on nasal blockage.~   "
84908|NCT01946022|"~     This study is intended to evaluate ovarian cells after being submitted do different in vitro~     fertilization protocols. The investigators will analyze hormones secretion and intracellular~     mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist~     protocol.~   "
84909|NCT01946009|"~     Cidofovir could be an effective drug for the treatment of Anal Intraepithelial~     Neoplasia(AIN).~   "
84910|NCT01945996|"~     In this study, an existing mobile health intervention to improve diabetes self-management~     will be combined with a social support module and tested for feasibility. The investigators~     hypothesize that this combination will be feasible and acceptable to both patients and their~     loved ones.~   "
84911|NCT01945983|"~     Current septic shock guideline recommends fluid resuscitation as the first treatment.~     Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid~     therapy. This can cause a certain duration of systemic hypotension before vasopressor is~     commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of~     septic shock may increase blood pressure quicker than start treatment with intravenous fluid~     alone. The rapid restoration of perfusion pressure may improve septic shock outcome.~   "
84912|NCT01945970|"~     Epidemiological studies indicate that regular consumption of three cups of black tea per day~     reduces the risk of stroke or myocardial infarction. In a number of previous nutrition~     intervention studies tea has been shown to improve vascular function as assessed by Flow~     Mediated Dilation (FMD).~   "
84913|NCT01945957|"~     This is a 4 part study:~      Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo =~     oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs.~     placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b.~     -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed~     within session.~   "
84914|NCT01945944|"~     Children who need to be on a ventilator often have thick secretions/mucus in their lungs.~     These secretions can obstruct the breathing tube and their windpipe, which can worsen lung~     function and prolong the need for the ventilator. Hypertonic saline is a medicine that is~     used to thin out secretions in patients with cystic fibrosis (and other conditions). We~     hypothesize that having children on a ventilator inhale this medication will shorten the~     amount of time that they need to be on the ventilator.~   "
84915|NCT01945931|"~     The purpose of this trial is to determine if the safe delivery smartphone application~     distributed to health workers in Ethiopia will decrease perinatal mortality and the~     incidence of postpartum haemorrhage. It is also the purpose to determine if the safe~     delivery smartphone application distributed to health workers in Ethiopia will increase~     health workers knowledge and skills in intra-partum management of active management of third~     stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4)~     neonatal resuscitation.~   "
84916|NCT01945918|"~     This project will test different ways of helping primary care practices to do a better job~     of self-management support (SMS) for their patients with diabetes.~   "
84917|NCT01945905|"~     -  Tuberculosis ( TB ) remains a major global public health problems and actions to ensure~          the diagnosis and complete treatment of all cases is the priority for the control of~          this disease. Despite the availability of effective anti-tuberculosis medications,~          there are still high levels of nonadherence to treatment. The nonadherence increases~          the morbidity and mortality of patients, decreases the cure rate, increases the~          community transmission and the increase of chronically ill patients enables the~          emergence of multi - drug resistant and increases treatment costs.~        -  Despite the knowledge about different forms of cost-effective delivery of DOT (directly~          observed treatment), recognition of the need to establish the DOT strategy related to~          the context from local studies, in Colombia and in Cali we hadn't had made studies~          similar than this one that establish the cost and results of the current DOT delivery~          strategy and to identify other ways to improve adherence and cure rate for the TB~          patients at reasonable cost for both: health services and families~        -  Therefore, this research aims to compare the cost -effectiveness of current DOT~          delivery method with an alternative extra- institutional delivery of anti -TB treatment~          in urban areas of Cali. A cost-effectiveness study was conducted from the institutional~          and familiar perspective with prospective information collection.~   "
84918|NCT01945892|"~     To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.~   "
84919|NCT01945879|"~     Venous thromboembolic events are considered to be a prognostic negative factor and small~     studies showed astonishing survival advantages using heparin as prophylactic treatment to~     prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie~     (CONKO) study group planned to conduct a randomized trial to investigate the impact of low~     molecular weight heparin (LMWH) in a prospective setting in patients with advanced~     pancreatic cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary~     stages we had to undertake a pilot trial to get information on safety and feasibility of~     combined chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with~     advanced pancreatic cancer who are at high risk of gastrointestinal bleeding due to local~     cancer spread.~   "
84920|NCT01945866|"~     Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as~     treatment for center-involved diabetic macular edema (DME), a substantial proportion of~     anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of~     retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more~     line improvement in visual acuity from baseline at 2 years in Protocol I, a previous~     DRCR.net (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of~     ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical~     coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes~     did not achieve complete resolution of retinal thickening (< 250 microns) by 2 years. Thus,~     there is a need for alternative or additional treatments that will improve vision by~     reducing retinal edema in eyes with persistent DME following previous anti-VEGF therapy.~     Intravitreal steroid is not as efficacious as ranibizumab in eyes with DME overall, but it~     has been shown to have a positive effect for DME in some eyes and might add benefit in eyes~     that are already receiving anti-VEGF.~      The main objective of this study is to assess the short-term effects of combination~     steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with~     that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and~     visual acuity impairment despite previous anti-VEGF treatment. This study will provide~     important information for the design of a future confirmatory phase III clinical trial on~     the efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision~     impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be~     the mean change in visual acuity at 24 weeks.~      Each study eye is required to complete a 12-week run-in phase. The run-in phase will~     identify study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an~     additional 3 injections while also collecting standardized visual acuity and OCT~     measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes~     will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit,~     if the eye still has persistent DME, it will be randomized to receive either intravitreal~     sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3~     injections. The randomized study duration is 24 week, during which a protocol visit takes~     place every month. The combination injections of sham+ranibizumab or dexamethasone~     +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit~     after randomization. In between, an intravitreal injection of ranibizumab only will be given~     to study eyes at the 4, 8, 16 and 20 week visits.~   "
84921|NCT01945853|"~     This is a pilot study to identify the degree of grey and white matter involvement in~     patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The~     imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the~     brain. These results will be correlated to the ALS Functional Rating Scale - Revised~     (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the~     ALS patients at baseline and at 6 month intervals. The participants will be asked to return~     every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital~     capacity and MRI as outlined above to monitor progression of the disease.~   "
84922|NCT01945840|"~     The purpose of this study is to assess whether the changes in gut hormones seen following~     Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen~     post-operatively.~   "
84923|NCT01945827|"~     The primary objective of this registry is to assess the safety and angiographic outcomes of~     endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.~   "
84924|NCT01945814|"~     In this study, investigators are trying to see if infusion of T cells (called CTLs) will~     prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV)~     reactivation or infection.~      Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem~     cell transplant. After receiving transplant, they are at risk of infections until a new~     immune system to fight infections grows from the cord blood cells. In this study,~     investigators are trying to give special cells called T cells. These cells will try to fight~     viruses that can cause infection.~      Investigators will test to see if blood cells from donor that have been grown in a special~     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can~     cause serious life-threatening infections in patients who have weak immune systems after~     transplant.~      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the~     virus infected cells after transplant. Some researcher have taken T cells from a person's~     blood, grown more of them in the laboratory and then given them back to the person during a~     viral infection after a bone marrow transplant. Some of these studies have shown a positive~     therapeutic effect in patients receiving the CTLs after a viral infection in the~     post-transplant period.~      Investigators will grow these cells from donor in the laboratory in a way that will train~     them to recognize and remove viruses when the T cells are given after a transplant. Since~     most donors have previously been infected with EBV, CMV, and adenovirus, investigators are~     able to use their T cells that remember these viruses to grow the CTLs. However, they now~     also have a new way of growing CTLs from donors who have not been infected with CMV.~   "
84925|NCT01945801|"~     This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or~     3) placebo pill in the treatment of obstructive sleep apnea in adults.~   "
84926|NCT01945788|"~     The primary objective of this study is to compare efficacy and safety of two formulations of~     teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with~     osteoporosis.~   "
84927|NCT01945775|"~     The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and~     efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice~     in patients who have locally advanced and/or metastatic breast cancer with germline BRCA~     mutations.~   "
84928|NCT01945762|"~     This is a European multinational, multicenter, non-interventional (observational) and~     prospective study. It is carried on to confirm in real life conditions the benefit/risk of~     vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with~     symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.~   "
84947|NCT01945515|"~     1. Study objective To evaluate the effect of robotic-assisted gait training combined with~          transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted~          gait training on gait function of chronic stroke patients~        2. Subjects chronic stroke patients with gait impairment~        3. Methods~             -  Group 1: Robotic-assisted gait training with anodal tDCS (45 min)~             -  Group 2: Robotic-assisted gait training with sham tDCS (45 min)~             -  Duration of treatment: 2 weeks, 5 times a week~             -  Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment~   "
84929|NCT01945749|"~     Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and~     disability. As no cure exists, management aims to reduce pain, improve function, and enhance~     quality of life. The recommended hierarchy of management should consist of exercise in first~     line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.~      The effect size of exercise therapy is of the same magnitude as most pharmacological~     treatments but is often without adverse effects. Local pharmacological treatment of the~     afflicted knee joint is recommended by means of intra-articular injections of~     corticosteroids, which is considered as a standard medical treatment of knee OA and are~     included in established guidelines for management of knee OA. While the two treatment~     approaches have been investigated separately in numerous clinical trials, the efficacy of a~     combined pharmacological and non-pharmacological approach is not known, despite the high~     rank of such combined treatment approach on the recommended hierarchy of management.~      The purpose of this study is to assess the effects of exercise therapy in combination with~     intra-articular corticosteroid injections on patient reported pain and function in patients~     with knee OA.~      The hypothesis is that the combined treatment approach (exercise therapy preceded by~     intra-articular injection of corticosteroid) enhances the clinical outcome compared to~     exercise therapy preceded by a placebo injection.~   "
84930|NCT01945736|"~     The purpose of this study is to learn more about how the study drug, methadone, prescribed~     by an infant's or child's physician as part of standard medical care, is processed in~     children and young adults. While this drug is used extensively in infants and children, it~     has not been extensively studied in this population.~      Physicians do not have very much information on how long it takes for methadone to be~     removed from the blood circulation and passed out of the body. Physicians need more~     information to guide how much and how often we should give methadone to children/young~     adults to ensure they get the maximum effect with the minimum amount of drug. During this~     research study, the study team will collect information about how this drug is processed in~     infants and children.~   "
84931|NCT01945723|"~     Tissue characterization will be performed, from different regions of the gastrointestinal~     tract in healthy volunteers.~   "
84932|NCT01945710|"~     Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and~     preliminary efficacy of E7389 liposomal formulation (E7389-LF) in patients with solid~     tumors. This dose-escalation study will determine the maximum tolerated dose, dosing~     schedules tested, the dose schedule regimen with a more favorable tolerability profile, and~     a preliminary indication of efficacy.~   "
84933|NCT01945697|"~     The aim of this study is to evaluate the association between several methylated genes and~     oral cancers. A prospective case control trial is designed with sample size estimated at~     least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or~     oral cancer, and ~60 subjects with normal oral mucosa. This study is approved by the~     National Taiwan University Hospital Research Ethics Committee. After signing the informed~     consent, all of the subjects will receive an intraoral examination and the oral epithelial~     cells will be collected. If abnormal oral lesion is observed, it will be photographed, and~     the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the~     gDNA will be extracted from the collected cells and standardized assay will be performed.~     Clinical sensitivity and specificity for these methylated genes will be evaluated.~   "
84934|NCT01945684|"~     Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled,~     Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in~     Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.~   "
84935|NCT01945671|"~     Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is~     a risk factor for anovulation , including in response to gonadotropin treatment .Further,~     even in women who are cycling regularly, obesity is associated with increased~     time-to-pregnancy and decreased chance of natural pregnancy.~      During obesity or periods of overnutrition, lipid accumulates in nonadipose tissues, notably~     skeletal muscle, liver, heart, and pancreas due to cellular uptake of exogenous fatty acids,~     triglycerides, and cholesterol as well as de novo lipogenesis in response to elevated~     glucose. The accumulation of intracellular lipid leads to high levels of free fatty acids~     that are subject to oxidative damage and the formation of cytotoxic and highly reactive~     lipid peroxides, which ultimately are detrimental to intracellular organelles, particularly~     the endoplasmic reticulum (ER) and mitochondria. Exposure of the ER to high levels of free~     fatty acids and lipid peroxides causes structural alterations that perturb ER function and~     lead to accumulation of unfolded proteins and calcium release. Failure of the UPR to~     reestablish ER homeostasis can lead to apoptosis .When mitochondria are exposed to high~     levels of free fatty acids, these can become oxidized by mitochondrial reactive oxygen~     species, forming lipid peroxides that damage essential proteins and uncouple mitochondrial~     function. This results in mitochondrial damage, which can cause further accumulation of~     lipids that cannot be catabolized, disrupted cellular homeostasis, and ultimately apoptosis~     .~      The cellular mechanisms by which obesity causes decreased conception rates are not known.~     Based on extensive evidence of obesity-induced lipotoxicity in other cells, it was~     hypothesized that obesity results in the activation of lipotoxicity pathways in the ovary.~     It was shown that lipid accumulation, ER stress, mitochondrial dysfunction, and apoptosis~     occur in ovarian cells and the oocyte in response to a high-fat diet.~      The aim of our study was to evaluate the influence of high BMI on oocytes, granulose cells~     and metabolites in the follicular fluid.~   "
84936|NCT01945658|"~     The main objective of this study is to determine what is the vitamin D status in Israeli~     women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low~     vitamin D level on IVF -ICSI cycles. We will evaluate as well the influence of increased~     estradiol level in IVF-ICSI cycles on peripheral vitamin D.~      We plan to follow vitamin D in infertile women undergoing IVF treatment for various~     indications, at baseline, during and after controlled ovarian hyperstimulation. Their levels~     will be measured at baseline (when they first present for basic investigations at our~     clinic), during the down-regulation phase of their treatment (if their protocol has a~     down-regulation phase), at each follow-up visit during stimulation (when they are asked to~     present for measurement of their estradiol (E2) levels), as well as at the conclusion of~     their treatment (i.e. the day of their pregnancy test). Along with endocrinology profiles,~     we will also record all the details of treatment outcomes in terms of embryo quality,~     implantation and clinical pregnancy rates. We also intend to perform follow-up studies of~     pregnancy outcomes.~   "
84948|NCT01945502|"~     The purpose of this study is to assess the efficacy of three different pharyngeal packing~     during routine rhinologic surgery in the prevention of postoperative nausea and vomiting,~     and to evaluate the influence of pharyngeal packing on postoperative throat pain.~   "
84949|NCT01945489|"~     This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared~     with placebo, in achieving a 100% reduction in urinary incontinence in patients with~     overactive bladder (OAB) not properly managed with an anticholinergic.~   "
84937|NCT01945645|"~     A pre-randomized study in primary health care was designed to investigate health education~     in a subpopulation extracted from general practitioners (GPs) in one Danish county in the~     treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People~     with Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the~     'Ready to Act' health education programme was to support the participants' competences in~     daily life and act appropriately with respect to their dysglycaemic condition. The~     achievement of action competence involved four learning objectives: intrinsic motivation,~     informed decision-making, action experience and social involvement. The programme was~     delivered in primary care settings (health centre or GP surgeries) by nurses, dieticians,~     physiotherapists and GPs.~   "
84938|NCT01945632|"~     In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one~     of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing~     with piezoelectric ultrasonic scraper [PU]; or 4) root planing with vertically oscillating~     ultrasonic device [VOU]. Post-treatment, the teeth will be extracted and their topography~     analyzed in 124 observations with white light confocal microscopy, measuring the roughness~     parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.~   "
84939|NCT01945619|"~     Subjects have a type of blood cell cancer, other blood disease or a genetic disease for~     which they received a stem cell transplant. After transplant while the immune system grows~     back the subjects have an infection with one or more of three viruses - Epstein Barr virus~     (EBV), cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite~     standard therapy.~      Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious~     life-threatening infections in patients who have weak immune systems. It usually affects the~     lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the~     pancreas and the eyes.~      CMV is a virus that can also cause serious infections in patients with suppressed immune~     systems. It usually affects the lungs and can cause a very serious pneumonia, but it can~     also affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people~     harbor this virus in their body. In healthy people CMV rarely causes any problems because~     the immune system can keep it under control. If the subject and/or the subject's donor are~     positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is~     weak post transplant.~      EBV is the virus that causes glandular fever or kissing disease. It is also normally~     controlled by a healthy immune system, but when the immune system is weak, it can cause~     fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma.~      This treatment with specially trained T cells (called CTLs) has had activity against these~     viruses when the cells are made from the transplant donor. However, as it takes 2-3 months~     to make the cells, that approach is not practical when the subject already has an infection.~     We want to find out if we can use CTLs which have already been made from another donor that~     match the subject and his/her donor as closely as possible and if the CTLs will last in the~     body and have activity against these viruses.~      In a recent study these cells were given to 50 patients with viral infections post~     transplant and over 70% had a complete or partial response. The purpose of this study is to~     make CTL lines leftover from that previous study available to patients with viral infections~     that have not responded to standard treatments.~      These virus-specific CTLs are an investigational product not approved by the FDA.~   "
84940|NCT01945606|"~     This is a study to investigate the safety and tolerability of the partial A1 agonist~     BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single~     dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study~     is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top~     of standard therapy for heart failure, particularly ß-blocker treatment.~   "
84941|NCT01945593|"~     To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the~     prevention and treatment of bleeding episodes in previously treated patients (PTPs)~     (children and adults from 0 to 75 years of age) with severe hemophilia A.~   "
84942|NCT01945580|"~     To compare transvaginal repair with a biologic graft to traditional native tissue repair in~     women surgically treated for anterior and/or apical pelvic organ prolapse.~   "
84943|NCT01945567|"~     The posterior subthalamic area holds promise as a target region for deep brain stimulation~     in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide~     tube surgical technique, subregions of the posterior subthalamic area can be individually~     targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona~     incerta may provide improved control of movement disorder symptoms than the more commonly~     stimulated dorsal zona incerta.~   "
84944|NCT01945554|"~     The purpose if this study is to assess the response to nerve root infiltration therapy in~     patients with cervical or lumbar disc herniations.~   "
84945|NCT01945541|"~     The purpose of this study is to evaluate a recently developed device, which measures body~     composition (i.e. the water content of the body) in the perioperative setting. Specifically~     the investigators will test the hypothesis, that extracellular water content after surgery~     correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore~     the investigators will test, if preoperative evaluation of body water helps to determine~     intraoperative fluid requirements and to guide fluid administration.~   "
84946|NCT01945528|"~     Background Tendinopathy is a difficult problem to manage and can result in significant~     patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but~     its efficacy remains controversial. Current experimental research postulates different~     efficiency among PRP formulations.Recent reviews showed that most clinical studies in~     tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy~     of pure-PRP in the management of epicondylitis.~      The investigators hypothesized that pure PRP associated to needling intervention can enhance~     tendon healing in epicondylitis, improve function and reduce pain.~      Methods and design Randomized double blind controlled trial, a total of 80 patients will be~     randomly allocated into one of two groups: PRP or control. Interventions: PRP group,~     ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate~     week for a total of two interventions. Control Group: US-guided needling with lidocaine each~     alternate week for a total of two interventions. Main outcome measure: Changes in pain and~     activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome~     measure score, before and six months after intervention.The primary end-point is 25%~     reduction in DASH. The investigators will compare the percentage of patients, in each group,~     that achieve a successful treatment defined as a reduction of at least 25% in the DASH~     score.~      Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in~     pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up.~     Changes in sonographic features and neovascularity at 3, 6 and 12 months.~   "
84960|NCT01945346|"~     This is an exploratory study to evaluate a new anti-inflammatory drug, PRX167700, in~     subjects with painful osteoarthritis of the knee.~      The purpose of this study is to investigate if PRX167700 improves the pain from~     osteoarthritis of the knee, and to assess its safety and tolerability. The study will also~     investigate PRX167700 pharmacokinetics.~   "
84950|NCT01945476|"~     Normally, higher levels of preoperational stress or anxiety affect behavior and recovery~     after the operation. Moreover, patients undergoing mastectomy are usually young women, and~     this demographic is known to experience higher levels of stress and anxiety than any other.~     Anesthetizing patients involves more than just anesthesia in operation; it also includes all~     of the preoperative treatments for optimizing a patient's condition and promoting quick~     postoperative recovery. Pharmacological premedication for anxiolysis or amnesia before~     anesthesia has been a common means of sedation that many studies have investigated. However,~     such studies have focused on alleviating patients' anxiety and on how far patients can obey~     induction for sedation; there has been no research on post-operational prognoses, the~     ultimate purpose of reducing anxiety.~      The well-known effect of pharmacological premedication is to reduce the capacity of the~     anesthetic. However, it is not confirmed whether this effect leads to better recovery after~     anesthesia, as this question has not been researched. Furthermore, recently some have argued~     strongly that premedication actually prolongs recovery and that it does not need to be~     applied to every patient. Recently, therefore, the use of pharmacological premedication has~     been left to the discretion of institutes or doctors in many cases.~      Among types of premedication, midazolam belongs to the class of short-acting benzodiazepines~     and is frequently used, as it induces meaningful anterograde amnesia and causes fewer~     aftereffects such as respiratory problems. In addition, its effects have already been~     demonstrated. However, research on the improvement of functional health after~     anesthesia—i.e., patients' quick return to normal life—is still poor and needs to be~     advanced.~      When measuring the degree of recovery, recent studies tend to focus on measuring how quickly~     patients are able to return to normal life rather than the recovery of specific symptoms. To~     this end, the most widely used method is the Quality of Recovery 40 (QoR-40) survey. It has~     a total of 40 items, which are classified into five categories: emotional state, physical~     comfort, psychological support, physical independence, and pain. Questions are answered~     using a 5-point scale, with 1 being worst and 5 being best. It takes 6.3 minutes on average~     to complete, and its test-retest reliability, internal consistency, and split-half~     coefficient have led it to be recognized as the most effective survey method. Moreover, it~     has been used in many studies investigating how the type of operation, method of anesthesia,~     additional medication, and gender affect anesthesia and the operation. Its validity for such~     research has been verified.~      Therefore, investigators can investigate the degree of postoperational functional recovery~     through the QoR-40 by comparing cases in which an operation is performed with or without~     midazolam.~   "
84951|NCT01945463|"~     Breast augmentation surgery is currently the most common elective plastic surgery performed~     in the US. With regards to the surgical technique, there are 4 incisional sites available~     for breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar,~     inframammary, and umbilical. The implant is inserted in either a subglandular (beneath~     breast tissue), submuscular (underneath the Pectoralis Major), or dual-plane (combination~     of both) manner.~      Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation~     of cardiac structure and function. Its use has increased dramatically in the last decades.~     We have encountered three women with congenital heart disease who have undergone breast~     augmentation, and their echocardiographic images were significantly limited after the~     implantation. There is only one case report in the medical literature suggesting that breast~     implants interfere with echocardiographic views .~      The underlying physical property of the silicone breast implants that causes interference~     with the ultrasound beam during echocardiographic examination is not known and has not been~     studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear~     to prevent penetration of ultrasound beams. The poor penetration appears to be persistent~     and unrevealing despite increase in gain or change in the ultrasound wave's frequency.~      Many women elect breast augmentation for cosmetic reasons. Women with congenital heart~     disease who have undergone cardiac surgery may have breast asymmetry or distortion and~     desire augmentation accordingly.~      Knowledge of the extent of impairment of breast implants to the echocardiographic~     examination is important for few reasons:~        1. Women with heart disease who need echocardiographic follow up and wish to undergo~          breast augmentation should be consulted as to the limitation of the echocardiographic~          examination following the procedure.~        2. Women without heart disease considering breast augmentation should be informed of~          potential echocardiographic interference, if echocardiography be needed in the future,~        3. Different surgical techniques may cause different masking effect.~        4. Different implants size and shape may cause different masking effect.~   "
84952|NCT01945450|"~     Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in~     manual revision of the uterus after labor in cases of residual placenta.~      Methods: a randomized control trial in which parturients for which the placenta was not~     separated or there is a suspected residual placenta will be divided randomly to two groups:~     (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of~     uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with~     Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3. In cases of allergy to~     Penicillin the antibiotic regimen will be: Gentamycin 240 mg*1, Clindamycin 600 mg*3.~      Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent~     hospitalization in the first 2 weeks after discharge.~   "
84953|NCT01945437|"~     The hypothesis of this study is that in staged bilateral total knee arthroplasty (TKA,~     magnesium sulfate administered during the perioperative period of the first TKA may decrease~     pain after the second TKA. It is known that pain is greater in the second TKA than in the~     first. Therefore, we compared pain of the second TKA between the magnesium and control~     groups.~   "
84954|NCT01945424|"~     The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a~     prospectively recruited pregnancy surveillance program designed to collect and analyze~     information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.~   "
84955|NCT01945411|"~     The purpose of this study is to assess the facial measurements for determining the proper~     sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors~     and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared~     with the length between mouth corner and mandible angle.~   "
84956|NCT01945398|"~     This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory~     muscle metaboreflex through the decrease of calf vascular resistance and increase of calf~     blood flow in Chronic Obstructive Pulmonary Disease (COPD).~   "
84957|NCT01945385|"~     Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a~     brief, theory-based, video intervention prior to standard contraceptive counseling and women~     exposed to standard counseling alone.~      Secondary: To identify predictors of immediate postabortal LARC uptake among all~     participants including the role of:~        -  Demographic and reproductive health history variables~        -  Baseline decisional balance, self-efficacy and stage of change for contraceptive~          initiation~   "
84958|NCT01945372|"~     Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and~     irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to~     patients' functioning and quality of life, ~40% do not respond to conventional treatment~     options.~      In this study, the investigators aim to examine a novel therapeutic approach for the~     treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF)~     probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either~     a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after~     training period. Comprehensive psychological assessment will be performed for outcome~     measure. The investigators hypothesize that EEG-NF treatment will enhance affective~     stability, thus improving patients' daily lives.~   "
84959|NCT01945359|"~     This study will observe participants with relapsing remitting multiple sclerosis who are~     switching therapies from natalizumab to dimethyl fumarate to determine disease stability.~   "
85302|NCT01940900|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®~     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
84962|NCT01945320|"~     A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with~     nutritional status and body composition. We will evaluate the body composition change among~     HD patients every three months with bioelectrical impedance analysis (BIA). The change of~     body composition will correlated with other clinical data including nutritional,~     inflammatory parameters and survival.~   "
84963|NCT01945307|"~     We need human blood to understand the immune response to infection and to test promising new~     vaccines against infectious diseases in the laboratory. One test is called the Serum~     Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing~     certain bacteria and can be an important measure of how effective a new vaccine may be.~      The samples would be used in the laboratory analysis of clinical trials of vaccines used in~     adults and children, and some samples in pre-clinical (animal) experiments testing new~     vaccines before they enter human-stage testing. Most people have some form of protection~     against most bacteria already, so not everyone is a suitable blood donor for this laboratory~     test. We therefore start by taking a small blood sample and test this one before asking for~     more blood if we found yours suitable for the work we do.~   "
84964|NCT01945294|"~     The purpose of this study is to estimate the difference in the efficacy between a 16-week~     treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus~     ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated~     participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable~     hepatitis C virus ribonucleic acid (HCV RNA).~   "
84965|NCT01945281|"~     The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared~     with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and~     infants. The primary hypothesis to be tested in the study is that caspofungin will be~     superior to amphotericin B deoxycholate with regard to the proportion of participants with~     fungal-free survival at the 2-week posttherapy follow-up visit.~   "
84966|NCT01945268|"~     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for~     vascular events from the network of INTER- CHF will be randomized to inactivated influenza~     vaccine or placebo and followed prospectively over three influenza seasons. 600 participants~     will be enrolled prior to influenza season and randomized to either influenza vaccine or~     saline placebo.~   "
84967|NCT01945255|"~     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage~     renal disease (ESRD), which means that it is important to find out risk factors of CVD in~     order to prevent or treat it. In recent years, there has been more and more recognition of a~     very high prevalence of CV calcification in the ESRD population. Many observational cohort~     studies have shown that CV calcification in these patients can predict mortality, CV~     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which~     may result in vessel calcification. Calcification leads to arterial stenosis and increasing~     arterial stiffness and then heart afterload, both contribute to the development of CVD.~     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a~     chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are~     prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness~     and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity~     is strongly associated with the presence and extent of atherosclerosis and constitutes a~     forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of~     peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and~     stenosis, which would increase the condition of infection and gangrene. Thus, life safety~     and quality would be influenced severely and early detection might prevent future~     amputation. Uremic patients also have a higher risk for metabolic syndrome. Therefore, more~     studies to evaluate the condition of arterial stiffness and PAOD, especially in HD patients,~     are needed for future management and preventions of CV related morbidity and mortality.~   "
84968|NCT01945242|"~     The purpose of this study is to determine the safety and efficacy of long-term combination~     therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes~     mellitus who failed to respond adequately to treatment with thiazolidinediones in addition~     to diet therapy and exercise therapy.~   "
84969|NCT01945229|"~     Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of~     the western population. It may cause symptoms such as irregular heartbeats, shortness of~     breath, and fatigue. It may also be asymptomatic (ie silent atrial fibrillation). In some~     cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of~     symptoms, there is an increased risk of stroke in some patients with this condition. Novel~     technologies are being developed to increase detection of silent atrial fibrillation, in~     order to find patients who might benefit from treatment with oral anticoagulants~     (blood-thinning medications) in order to reduce the risk of stroke. One of these~     technologies is thumb-ECG, a simple way for a patient to have his or her heart rhythm~     reliably analyzed at home.~      Hyperthyroidism (sometimes referred to as toxic goiter) is defined as an excessive~     production of thyroid hormone. It is known that hyperthyroidism may cause atrial~     fibrillation in about 8% of cases.~      Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating~     their hormonal disturbance, in order to find episodes of silent atrial fibrillation.~      Design: Prospective observational study.~      Hypotheses:~        -  Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial~          fibrillation in hyperthyroid patients.~        -  Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared~          to the normal population even after hyperthyroidism is treated.~        -  Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial~          fibrillation are at increased risk of stroke and should be considered for treatment~          with oral anticoagulants.~   "
84970|NCT01945216|"~     The purpose of this study is to determine the safety and efficacy of long-term treatment~     with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded~     inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy,~     exercise therapy, and α-glucosidase inhibitor.~      In addition, examining the safety and efficacy of alogliptin in patients with renal~     impairment, information on the appropriate dosage of alogliptin according to the severity of~     impaired renal function should be collected.~   "
84971|NCT01945203|"~     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage~     renal disease (ESRD), which means that it is important to find out risk factors of CVD in~     order to prevent or treat it. In recent years, there has been more and more recognition of a~     very high prevalence of CV calcification in the ESRD population. Many observational cohort~     studies have shown that CV calcification in these patients can predict mortality, CV~     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which~     may result in vessel calcification. Calcification leads to arterial stenosis and increasing~     arterial stiffness and then heart afterload, both contribute to the development of CVD.~     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a~     chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are~     prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness~     and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity~     is strongly associated with the presence and extent of atherosclerosis and constitutes a~     forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of~     peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and~     stenosis, which would increase the condition of infection and gangrene. Thus, life safety~     and quality would be influenced severely and early detection might prevent future~     amputation. As compared with HD or pre-dialysis patients, uremic patients treated with PD~     have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition~     of arterial stiffness and PAOD, especially in PD patients, are needed for future management~     and preventions of CV related morbidity and mortality.~   "
84972|NCT01945190|"~     Acupuncture is used extensively by patients worldwide for a variety of illnesses. While~     research is beginning to show effectiveness in clinical pain, the mechanisms underlying how~     these effects are evoked are poorly understood. Experimental models in healthy human~     volunteers can more closely control the variables of acupuncture needling and begin to~     separate out the relative contribution of specific components of needling and needle~     stimulation. By examining acupuncture's effects on experimental inflammatory models with~     well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding~     how acupuncture produces its clinical effects. We propose to establish a model which could~     be used as a template to examine the individual components contributing to acupuncture's~     clinical effects on inflammation and pain. We hypothesize that acupuncture will have~     analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well~     as a model of heat pain testing which activates central sensitization.~      Twenty healthy human volunteers will participate in a crossover study with active~     acupuncture and sham acupuncture interventions. They will be tested for their minimal~     erythemal dose (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be~     administered on the lower leg. Background information will be collected which could affect~     individuals' sensitivity to pain such as anxiety and depression, as well as their~     expectations regarding acupuncture treatment.~      The following day they will return for the first experimental day. A measurement with Laser~     Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will~     be performed using a computer controlled thermode both on and off the ultraviolet B lesion.~     On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal~     summation of heat pain.~      Next, a licensed acupuncturist will perform either true electroacupuncture or sham~     electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are~     blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler~     and heat pain testing will be repeated. The difference between pre-acupuncture and~     post-acupuncture measurements will represent the acupuncture -induced analgesic and~     anti-inflammatory effects.~      Participants will return for another ultraviolet B exposure adjacent to the first, and will~     receive whichever sham or true acupuncture intervention was not performed on the first study~     day.~   "
84973|NCT01945177|"~     It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early~     gastric cancer. This could conceivably be due to the fact that these lesions may only~     present as subtle mucosal changes on conventional white light endoscopy (WLE) and thus be~     easily missed. In narrow band imaging (NBI) a rotating interference narrow band filter is~     interposed after the xenon light source such that when the NBI mode is switched on, discrete~     blue and green wavelengths are used and this improves mucosal surface contrast and~     facilitates visualization of mucosal details. A new NBI system is available that allows~     brighter illumination. We hypothesize that bright -NBI is superior to WLE in detecting focal~     gastric lesions such as gastric intestinal metaplasia, dysplasia and early gastric cancer in~     subjects undergoing gastroscopy.~   "
84974|NCT01945164|"~     Cancer is a worldwide clinical and economic problem. Conventional approaches to treating~     cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as~     combined therapies. Recently, targeted therapies including antibodies and small molecule~     inhibitors have also demonstrated clinical benefit. It is now possible to study different~     genetic lesions involved in cancer types due to advances in genomic methodologies. The~     investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases,~     including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ),~     fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1,~     FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously~     and will likely have effects on the integrity of tumor neovasculature and angiogenesis.~     Together with the ability to induce a novel cell cycle arrest, the spectrum of activities~     that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.~      The rationale and purpose of this maintenance study is to allow a subject receiving clinical~     benefit from XL999 to continue treatment.~   "
84975|NCT01945151|"~     To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in~     the agonist and antagonist muscles of spastic hemiparetic patients.~      The specific objectives are:~        -  Evaluate the resistance movement, strength and muscle electrical activity before and~          after application of Neuromuscular Electrical Stimulation in spastic muscle~          (gastrocnemius).~        -  Evaluate the resistance movement, strength and muscle electrical activity before and~          after application of Neuromuscular Electrical Stimulation in the spastic antagonist~          muscle (tibialis anterior).~        -  Compare the risk of falls after application of Neuromuscular Electrical Stimulation in~          both muscles studied.~   "
84976|NCT01945138|"~     The purpose of this study is to determine the effectiveness of closed loop insulin pump~     therapy to control blood sugar following total pancreatectomy and islet auto-transplantation~     (TPIAT).~   "
84977|NCT01945125|"~     To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during~     radioiodine therapy in renal function.~   "
84978|NCT01945112|"~     Friction foot blisters are one of the most common and often debilitating complaints of all~     athletes, and hikers and runners in particular. Blistering rates in the literature of~     outdoor hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine~     whether applying paper tape to the areas of the foot where blisters historically occur in~     endurance runners can prevent the incidence of friction blisters.~   "
88222|NCT01902537|"~     The purpose of this observational study is to investigate health related quality of life~     (QoL) in Korean female participants with chronic constipation (long term decreased number of~     or difficulty making bowel movements) having received treatment previously.~   "
84979|NCT01945099|"~     Closed loop artificial pancreas systems have been under development for the control of~     blood sugars in those living with diabetes. These systems consist of a continuous glucose~     sensor, which sends a signal to a computer program that automatically determines how much~     insulin to give. The computer program then tells an insulin pump to deliver the insulin.~     While such systems have been tested under a number of conditions, post-meal blood sugars are~     difficult to control. Specifically, we will be looking to see if using hyaluronidase~     improves the ability of the closed loop artificial pancreas to better respond to meal~     related highs and lows.~   "
84980|NCT01945086|"~     The purpose of this study is to assess the safety and effectiveness of 2 doses of~     ustekinumab compared with placebo (inactive medication) in adult Japanese participants with~     severe atopic dermatitis.~   "
84981|NCT01945073|"~     Increased knowledge about an illness can increase self-management among those afflicted. In~     order to facilitate people with sickle cell disease living a longer and healthier life, they~     should be taught to manage their illness.An adolescent with a chronic illness has many~     unique challenges, in addition to maneuvering the turbulent adolescence period itself. It~     has been that better knowledge and more positive perceptions of their illness equate not~     only to better control of their illness but also better quality of life.Studies have also~     shown the benefits of self-management: when patients are responsible for managing their own~     illness, their clinical outcomes and quality of life improve and they become less dependent~     on health care services.~      In this study we aim to examine if knowledge, and any changes in knowledge, will each have~     any association with Quality of Life (QOL) and their perceptions of their illness (IP). We~     also seek to investigate the effects of an educational booklet, as well as an intervention~     including the educational booklet with formal counselling on their knowledge, QOL and IPs.~   "
84982|NCT01945060|"~     The purpose of this study is to see if the Artificial Pancreas (AP) Platform can~     successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump~     therapy in a hospital setting. Investigators will also be studying to see if the heart rate~     informed Control To Range (hrCTR) can improve the performance of the system during and~     immediately after exercise.~   "
84983|NCT01945047|"~     Depression carries the largest burden of all medical disorders in middle to high income~     countries, as determined by the World Health Organization. Despite many antidepressant~     strategies, only a third of patients get well after their first treatment and a third remain~     ill after several treatments. Moreover, antidepressant treatments all have a delayed action~     ranging up to several weeks.~      Ketamine (KET) has been used for decades as a sedative and anesthetic. In~     treatment-resistant depressed patients(TRD), an intravenous dose much lower than necessary~     for anesthesia may produce a robust antidepressant effect and may even abolish suicidal~     thoughts within hours, peaking within 24 hours. But, its antidepressant effect generally~     lasts only days.Previous studies examining KET in TRD have been critiqued for lack of an~     effective placebo measure due to brief perceptual experiences associated with KET. Thus, the~     current study compares KET against a short-acting sedative. The phases of this study compare~     response to a single KET injection to 6 injections over 2 weeks. Next, KET responders are~     given 1 injection a week for 3 weeks of either KET or the sedative agent to determine if~     beneficial effects of KET are maintained, and to assess duration of its benefits after~     repeated administration. The genetic profile of patients for a substance promoting contacts~     between cells and brain will be determined to investigate if response to KET could be~     predicted with that blood test. This substance, as well as several chemicals that produce~     inflammation, will also be measured in the blood to investigate their role in the effect of~     KET. Patients will receive, in total, no more than the equivalent of two to three anesthetic~     dose of KET. Results from this study will help establish the beneficial effects of a single~     KET injection as a rapid intervention for major depression, and to investigate the~     possibility of obtaining a prolonged antidepressant effect with repeated injections.~   "
84984|NCT01945034|"~     This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical~     placebo for the relief of pain associated with a first or second degree ankle sprain. Both~     twice daily and three times daily regimens will be evaluated.~   "
84985|NCT01945021|"~     To assess treatment effectiveness and safety of oral crizotinib administered to East Asian~     patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive~     for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an~     ALK mutation~   "
84986|NCT01945008|"~     HCV infection is the most frequent cause of liver chronic disease, cirrhosis and~     hepatocellular carcinoma in western countries.~      To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus~     ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and~     4, and is associated with important adverse side effects, that lead to treatment~     interruption in approximately 30% of cases.~      The recent association of first generation HCV- specific direct-acting antiviral agents~     (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates,~     also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV.~     While several new DAAs are in development, the ultimate goal is represented by IFN-free~     regimens, that will provide a great advantage in terms of patients adherence to therapy and~     quality of life.~      In this context, prospective observational studies are needed to evaluate the real and~     long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety,~     costs and impact on patients quality of life.~      The Italian context~      Italy is the European country with the greatest number of HCV infected people (average, 3%~     of population), with higher prevalence in the center and in the south of the country,~     especially in older individuals, and the highest mortality caused by hepatocellular~     carcinoma. Genotype 1 is the most frequent one (in more than 50% of infected people). DAAs~     were approved at the end of 2012. For these reasons, Italy represents an interesting context~     for collecting data on long-term efficacy, safety and tolerability of new anti-HCV~     treatments.~      The PITER cohort study, developed in the frame of Italian Platform for the study of the~     therapy of viral hepatitis a prospective observational study, is based on a large cohort of~     HCV infected patients from more than 100 clinical centers distributed on the whole national~     area (we can provide a list on demand).~      The PITER cohort study will provide exhaustive information on:~        -  Clinical and virologic natural history of all enrolled patients~        -  Therapeutic outcomes in different clinical/virologic contexts and in special~          populations starting a new treatment (i.e. Predictors of virological response, disease~          progression or fibrosis regression~        -  quality of life of patients~        -  pharmacokinetics of drugs and pharmacological interactions~        -  Short, middle and long term side effects~        -  Minimum duration of therapy to reach the sustained virological response~        -  Aspects related to personalization of treatment in specific populations: old people,~          women, immigrants or marginalized populations, patients not responding to standardized~          treatment protocols, patients waiting for liver transplantation or transplanted~          patients~        -  Role of viral variability in the natural history of the disease and in the response to~          treatment~        -  Pharmacoeconomics and risk-benefits analysis. All these information will be used to~          evaluate prescription appropriateness in Italy, with important implications for public~          health..~      PITER may also represent a starting point and a base for future clinical studies,~     contributing to the optimization of therapeutic protocols and to the formulation of~     guidelines on the use of new therapies for HCV treatment~   "
84987|NCT01944995|"~     Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is~     also more and more used in infants with severe acute bronchiolitis. There is no evidence~     that nCPAP improves outcome, but several studies showed that it reduces work of breathing~     (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP)~     therapy, also used in neonatal units, has recently been suggested for bronchiolitis~     management. This technique allows warmed and moist gas administration protecting nasal~     mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous~     positive pressure, reducing WOB, and seems much more comfortable and better tolerated by~     babies than nCPAP. There are no studies comparing both techniques for bronchiolitis~     management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy~     in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is~     to compare efficacy and tolerance of both techniques. We propose to lead an open, single~     center, crossover randomized study. Each patient will receive the two treatments. Three~     consecutive periods will be studied: first one (minimum 2 hours), with the first technique~     CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the~     second technique (treatment 2); Third period (6 hours) with the second technique. The~     primary endpoint will be the comparison of WOB (estimated by the calculation of the~     transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and~     tolerance of each technique will be evaluated and compared by compared measuring respiratory~     rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score~     during the third period. Nine subjects by groups are required.~   "
84988|NCT01944982|"~     To determine safety profile of immunotherapy with natural killer cells and activated~     expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell~     lymphoblastic leukaemia and lymphoma.~   "
84989|NCT01944969|"~     To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment~     in patients with Major Depressive Disorder (MDD)~   "
84990|NCT01944956|"~     Our objective was to evaluate maturation of sucking and swallowing in preterm infants using~     a non-invasive method: assessment of swallowing sounds. Findings in healthy term infants~     were used as reference values.~   "
84991|NCT01944943|"~     The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of~     patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).~   "
84992|NCT01944930|"~     Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or~     gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered~     participation in the study. The proposed study is a randomized, controlled feasibility trial~     with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic~     narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of~     peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the~     peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI.~     The order of white-light and NBI laparoscopy will be randomized for each patient (crossover~     design). Frozen-section histopathology biopsies will be retrieved of all~     suspicious-appearing abnormalities using best clinical practices. The number of detected~     peritoneal metastases will be compared between each diagnostic laparoscopy technique. To~     gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be~     surveyed through a 1-year follow-up.~   "
84993|NCT01944917|"~     Previously it has been demonstrated that exposing the heart to electromagnetic field during~     exercise stress test improves the recovery following the stress test. This is explained by~     the effect of the electromagnetic field on the sympathetic activity of the heart. In the~     present study we would like to further investigate the effects of electromagnetic field on~     autonomic nervous system function in patients with chronic musculoskeletal pain that usually~     have high sympathetic activity. Each patient will be exposed to 20 minutes of~     electromagnetic field during which the autonomic nervous system function will be measured.~     In addition, patient tolerability to the exposed magnetic field will be investigated. We~     assume that short exposure to electromagnetic field would result in decreased sympathetic~     activity and therefore, on the long run, could be suggested as a therapeutic tool for such~     patients.~   "
84994|NCT01944904|"~     This study aims to determine whether the use of a supplement called xylooligosaccharide~     (XOS) increases the number of good bacteria that live in human intestines and can maintain~     healthy blood sugar levels, and whether XOS has any unpleasant or unexpected side effects~     when consumed at different dosages. Subjects who participate in this study will be~     randomized to receive an eight week supply of either a lower dose of XOS or placebo (no~     active substance). This will be determined randomly, in a process similar to flipping a~     coin. Blood samples will be taken at each visits, including an oral glucose tolerance test.~     Subjects will also be asked to collect and bring in stool samples at three different time~     points during the study.~      Subjects will have a 50/50 chance of being assigned to the either study group. This is a~     double-blind study which means neither the study investigator nor the subject will know to~     which group he/she has been assigned. In case of an emergency, the study doctor can get this~     information.~   "
84995|NCT01944891|"~     Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique~     was collected. A cross-sectional study was carried out in 2010 in two seasons,~     January-February and May-June. Participants (total n=551) were recruited from Quelimane (the~     provincial capital), Maganja da Costa district and Morrumbala district.~   "
84996|NCT01944878|"~     The aim of this study is to assess the role of portal hypertension of peptic ulcer disease~     in liver cirrhosis and chronic hepatitis.~   "
84997|NCT01944865|"~     The aerobic fitness is important for mountain bikers, but riders should also be able to~     generate maximal and supramaximal efforts in some crucial phases of the competition.~     Although there is an increase interest in high-intensity aerobic training, to investigators~     knowledge, there are no studies examining the effects of interval (INTV) or intermittent~     training (INTM) in mountain bikers. The aim of this study was to compare the effects of INTV~     and INTM on aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset~     of blood lactate accumulation) but more importantly on performance as measured using a~     controlled mountain bike race, i.e. simulation. The investigators hypothesized that INTV and~     INTM training were equally effective in improving Wmax, Lactate threshold and onset of blood~     lactate accumulation, but INTV was superior in enhancing performance in mountai bike race~     simulation.This hypothesis is due to studies that have shown higher gains in performance~     with long duration of aerobic high intensity interval training in comparison to the shorter~     training at a higher intensity.~   "
84998|NCT01944852|"~     The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in~     incident CAPD patients aged of 65 at minimum :~        -  One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose~        -  One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.~   "
84999|NCT01944839|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®~     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
85000|NCT01944826|"~     Prospective, multicenter, observational registry collecting data from subjects with~     Tako-Tsubo (stress-induced) cardiomyopathy (TTC). Uniform, complete, and accurate data will~     be collected on the subject's medical history, during index hospitalization for TTC, and~     during follow-up.~      The objectives are to evaluate the prevalence and incidence of cancer in patients with TTC,~     to document the underlying causes of death during hospital stay and during follow-up, to~     determine the long-term prognosis, and to identify possible predictors of short and~     long-term mortality.~   "
85001|NCT01944813|"~     Communication about end-of-life issues is often suboptimal. A way to improve the quality of~     end-of-life care is Advance Care Planning (ACP). ACP is a discussion between an incurable~     ill patient and the health professionals about preferences for end-of-life care. In Denmark,~     there is no tradition of systematic communication with patients about end-of-life care. The~     aim is to investigate how ACP can be beneficial among incurable ill patients treated in an~     outpatient context and if the concept is feasible in a Danish context. The study is designed~     as a prospective randomised controlled trial. Patients from relevant departments will be~     included and randomised in two groups: one receiving usual care and the other receiving~     usual care and ACP. Data will be collected from Electronic Patient Files and from~     questionnaires. If ACP is effective, it will improve the quality of end-of-life care for~     patients and their families and reduce the psychological distress in the bereaved relatives.~   "
85002|NCT01944800|"~     Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether~     ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned~     invasive strategy in terms of clinical outcomes.~   "
85005|NCT01944761|"~     The objectives of our proposed study are to (a) evaluate the feasibility of conducting a~     structured exercise program in children treated with cranial radiation for brain tumors, (b)~     test whether exercise results in improved thinking skills and emotional function, and (c)~     examine potential mechanisms of improved outcome, particularly recovery of white matter and~     grey matter.~   "
85006|NCT01944748|"~     The goal of this project is to conduct a pilot evaluation of a parent-child mediation~     program for at-risk youth. It is investigating whether families who receive parent-child~     mediation show greater improvement in family functioning, as well as adolescent substance~     use, academic performance, and delinquency, over a 6-week and 12-week period compared to a~     wait-list control sample.~   "
85007|NCT01944735|"~     The purpose of this study is to assess the safety and tolerability of multiple oral doses of~     CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This~     study will include two dose levels. For each dose level, blood samples will be collected for~     exploratory PK and PD assay validation. In addition, sputum will be collected for~     exploratory biomarker analysis. Following multiple dose administration, pulmonary function~     and exploratory lung clearance index (LCI) measurements will be taken.~   "
85008|NCT01944722|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human~     Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media~     diluted in HPV diluent to adjudicated histology results from biopsy.~   "
85009|NCT01944709|"~     The prognosis of patients with metastatic melanoma is poor and current available treatments~     are limited. Identification of a number of melanoma-specific tumor antigens that are shared~     by tumors from different patients, provides attractive targets for immune-based therapies~     (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide~     vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific~     immune responses. In various animal models and in clinical trials it was shown that the most~     potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs~     are professional antigen presenting cells (APC) that are critical in the initiation of~     cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules~     needed for the induction of immune responses and have the capacity to migrate into secondary~     lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides~     and injected subcutaneously. The concept is to induce or to propagate already existing tumor~     specific killer T cells.~   "
85010|NCT01944696|"~     Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted)~     phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low~     birth weight newborns in a pilot randomized controlled trial.~      Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous~     phototherapy in extremely low birth weight (ELBW) infants without the risks that have been~     associated with continuous phototherapy.~   "
85011|NCT01944683|"~     The study will examine midazolam pharmacokinetics following single dose administration of 3~     planned dose levels of GGF2 .~   "
85012|NCT01944670|"~     The purpose of this study is to confirm the safety and effectiveness of the Internal Joint~     Stabilizer - Elbow.~   "
85013|NCT01944657|"~     A. Introduction to the Problem~      This field experiment is intended to explore whether supplemental transcranial magnetic~     stimulation (TMS) is more effective than standard medication mono-therapy for the treatment~     of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the~     practice guidelines of the American Psychiatric Association for the treatment of major~     depression.~      B. Importance of the Area of Study~      The safety, efficacy and value of TMS treatment has been established through the four-phase~     FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer~     reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict~     enrollment and methodological requirements. TMS is now used in actual clinical practice and~     there is an opportunity to extend laboratory research and typical, highly controlled field~     settings to applied settings. This study is designed to gather data on safety, efficacy and~     utility of TMS as it is used in clinical practice.~      C. Need for Additional Research~      Efficacy and safety of these interventions have been scientifically established and~     meta-analyses of these studies underscore the efficacy and safety of two treatment~     interventions to be employed in this study: 1) standard medication monotherapy and 2)~     standard medication therapy supplemented with TMS. However, many authors conclude that~     depression can be difficult to treat and there is an ongoing need for additional research.~     Depression remains a major public health problem.~   "
85014|NCT01944644|"~     This is a double-blind, randomized, sham-controlled phase II study of the effects of Low~     Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant~     Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind~     treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting~     state fMRI will be performed at baseline and following the third and final treatment~     session.~   "
85015|NCT01944631|"~     The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on~     cold symptoms. The effect of treatment on the duration of the cold and the patients viral~     load plus cytokine level indicating the inflammatory response will be analyzed.~   "
85016|NCT01944618|"~     The study purpose is to assess adverse events in patients with Type 2 diabetes who have~     newly been prescribed Forxiga for the management of glycemic control~   "
85017|NCT01944605|"~     Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one~     third of a million deaths annually in the US, accounting for half of all cardiovascular~     deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer~     combined. Twenty to fifty percent of CA patients (pts) can be resuscitated initially but~     many die before hospital discharge or suffer permanent neurologic damage. Therapeutic~     hypothermia (TH) improves survival and neurological outcomes. Despite aggressive, targeted~     post arrest management, including TH, approximately 50% of pts die before leaving the~     hospital due to global ischemia-reperfusion injury (IRI) known as the post arrest~     syndrome, 1 which is a sepsis-like state characterized by elevated markers of cellular~     inflammation and injury. It is believed that TH works by decreasing the body's basal~     metabolic rate (BMR) and attenuating the systemic inflammatory response (SIR). However,~     specific triggers of the intense pro-inflammatory response are unclear. This gap in~     knowledge must be closed to identify targeted therapy to decrease IRI and improve outcomes.~      Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA~     and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the~     intestine increases intestinal permeability leading to intestinal microbial translocation~     and endotoxin release that can stimulate and perpetuate systemic inflammation and cause~     subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy~     expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The~     purpose of this novel pilot study is to detect systemic endotoxin release following CA in~     humans and determine association with cytokine activation, and BMR alterations during TH.~   "
85027|NCT01944475|"~     Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be~     physically and emotionally devastating for kids and is sometimes caused by an underlying and~     medical condition. One sign of precocious puberty in small girls is breast development~     (thelarche). This can persist without other physical changes of puberty, it may continue~     into precocious puberty, or it may disappear. This project will improve the diagnostics of~     precocious puberty in girls and improve our ability to identify which girls with thelarche,~     who will develop precocious puberty and need medical treatment.~   "
85303|NCT01940887|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with either Avastin® or Eylea®~     compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal~     neovascularization secondary to age-related macular degeneration (AMD).~   "
85018|NCT01944592|"~     Physical examination of the pelvis is an important core skill that medical students need to~     acquire. However, due to its intimate nature some students are graduating unable to perform~     competent pelvic examinations. Gynaecological Teaching Associates (GTA's) are women who have~     been trained to be examined and give valuable feedback to the students. In North America~     GTA's are quite commonly used in the medical curriculum and they have also been used in~     Canada, Australia and Scandinavia. In the UK pelvic examination is mainly taught using a~     combination of clinic patients, pelvic models and patients anaesthetised for surgery. In~     Birmingham we have already started using GTA's and like other Universities such as Oxford~     the students have given positive feedback.~      GTA's are paid professionals and hence introducing this method of teaching has financial~     implications for Universities. Unless it is proven to be worthwhile it is unlikely that~     academic institutions will introduce and maintain GTA programs. One UK study did show that~     those who had been trained with a GTA's and pelvic models were significantly better than~     those who had been trained with pelvic models alone. However, in this study the GTA training~     was supplementary to the normal curriculum so the amount of teaching rather than the style~     of teaching may have acted as a confounding factor. Therefore, a large randomised trial of~     trainees on the Obstetrics and Gynaecology (O&G) programme comparing those given an initial~     teaching session on a pelvic model and those taught by GTA's is needed to assess the~     effectiveness of GTA's on confidence and competence of the students by the end of the~     training programme is needed.~   "
85019|NCT01944579|"~     Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce~     smaller molecules which may impact health. In addition, evidence suggests that this process~     may be affected by body fatness. This study aims to investigate absorption of blackberry~     polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by~     intestinal bacteria, and how these processes differ for obese and lean individuals. It is~     hypothesized that polyphenol absorption and metabolism will differ between obese and lean~     individuals and that differences in intestinal microbiota may play a role.~   "
85020|NCT01944566|"~     The malodour generation of a person's armpit is caused by the bacteria thriving on that~     armpit. In order to alter or reduce once bad body odour, the living microbial community on~     the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to~     the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the~     bacteria living on the armpit is examined by means of molecular techniques. The microbial~     transplantation and its follow-up happens under the supervision of a medical doctor.~   "
85021|NCT01944553|"~     The main objective of the study is to evaluate the feasibility of using the robotic assisted~     device ROSA™ for pedicle screws placement. This device is currently used in cranial~     neurosurgery but its applications can be extended to other fields, such as spinal surgery.~     In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and~     safety of surgery for the patient.~   "
85022|NCT01944540|"~     This study is aimed to analyze the outcomes after conventional endoscopic submucosal~     dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is~     more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without~     stalk.~      Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed~     circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in~     diameter with snaring, then resected by using an electric current.~      The investigators expect optimized ESD with snaring can provide more time-saving procedure~     with comparable en-bloc resection rate and perforation rate, when compared with the~     conventional ESD method.~   "
85023|NCT01944527|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     direct-acting antivirals therapy in liver transplanted patients who experienced HCV~     recurrence.~      This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective~     collect of biological and clinical data's in the liver transplanted patients with recurrent~     HCV infection and treated with direct-acting anti-HCV agents.~   "
85024|NCT01944514|"~     Worldwide three million people a year die from sudden cardiac death (SCD). In most cases~     there is no warning and the heart is stopped by a sudden arrhythmia. We know that some~     people are at high risk of sudden cardiac death and can prevent their deaths with an~     implantable cardioverter defibrillator (ICD) that is implanted in a minor operation.~      However, most people who die from sudden cardiac death are not found to be at high risk by~     our current risk markers and 40% of the people who have ICDs do not have therapy within the~     first 4 years after implant. We need new and better ways of identifying people who are at~     high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our~     understanding of the electrical signals in the heart has increased considerably in recent~     years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic~     science work. This study aims to take the understanding of action potential duration (APD)~     restitution gained through our work and other studies in humans and in computer simulations~     and translate it into a fresh way of assessing risk of sudden cardiac death.~      This study will carefully examine electrical activity, using APD restitution, in the hearts~     of patients who are having ICDs fitted because of their high risk of sudden cardiac death~     and combine this with a detailed heart scan, assessment of autonomic nervous system and gene~     expression data. We will then follow these patients up to see who benefits from their ICD.~     This wide ranging information will give us as complete a picture as possible of the factors~     that cause sudden cardiac death. We hope to use this to identify better predictors of sudden~     cardiac death.~      The study hypotheses are as follows:~      Primary~        1. Regional Restitution Instability Index (R2I2) will be significantly higher in patients~          reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.~        2. An R2I2 cut-off of 1.03 will partition patients into high and low risk groups.~           Secondary~        3. Peri-infarct zone mass in grams will be significantly higher in patients reaching the~          endpoint of ventricular endpoint / sudden cardiac death than in those not.~   "
85025|NCT01944501|"~     This study aimed at trying transcranial magnetic stimulation and transcranial direct current~     stimulation as potential treatments to decrease tinnitus in patients with significant~     hearing loss.~   "
85026|NCT01944488|"~     The project aims to establish the normal LH and FSH response to a standardized GnRH dose in~     healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH~     response in girls with early puberty development.~      The novel data may help to determine whether the girl is in early puberty or not.~      Healthy girls under 6 years of age attending routine examinations including an i.v. line for~     other causes are included in this study. Our examinations also include bone age~     determination, Tanner stage determination, and anthropometric measures (height and weight).~     10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36~     months, 36-48 months, 48-60 months and 60-72 months are included.~   "
85055|NCT01944111|"~     Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable~     gastric banding in prospective clinical trial.~   "
85028|NCT01944462|"~     The overall goals of this program are to measure the impact of a pharmacist pneumococcal~     vaccine education program (PPVP) using a senior center model of care and provide the~     pneumococcal vaccine to eligible participants.~      Hypotheses~        1. PPVP will result in improved knowledge and awareness in older minorities in the senior~          center setting (primary hypothesis);~        2. Participants who are vaccinated through the project will experienced increased trust in~          receiving vaccines from a pharmacist;~        3. Participants will be satisfied with and trust the PV information provided by~          pharmacists in the PPVP;~        4. PPVP is an efficient approach to educating patients in the senior center based on its~          costs;~        5. Participating pharmacists will be activated to implement PPVP learnings in their~          practice.~   "
85029|NCT01944449|"~     The objectives of this study are to examine the effects of chronic, (12 weeks)~     administration of Whey protein on HbA1c, and postprandial glucose (PPG).~   "
85030|NCT01944436|"~     Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause~     memory loss, behavioural and motor disabilities that impair quality of life. Cognitive~     enhancers help people afflicted with these conditions. However, some people do not benefit~     from this treatment, while others experience serious side effects. Side effects and poor~     response lead to hospitalization and early institutionalization. Pharmacogenomics, the study~     of how DNA variation can influence drug effects, will be combined with functional changes in~     brain imaging in response to cognitive enhancers in patients with Lewy body disease. The~     goal is to develop a predictive test that can be administered in the clinic to aid~     physicians' choice of initial medication. This can reduce health care costs and improve~     treatment to Canadians suffering from these devastating disorders.~   "
85031|NCT01944423|"~     The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting~     treatment of smoking cessation for individuals with panic attacks. The investigators~     hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence~     greater smoking abstinence rates and decreased panic symptoms after receiving a combined~     CBT-based treatment for smokers with panic attacks.~   "
85032|NCT01944410|"~     The traumatic bone cyst (TBC) is an infrequent nonepithelial lined cavity of the jaws, which~     was first expressed by lucassin 1929, the lesion has attracted a great deal of interest in~     the dental literature, but its pathogenesis is still not evidently recognized. It determines~     a bone cavity of irregular shape which appears like a cyst on a radiograph, and~     histopathologically there are no elements to confirm a diagnosis of a cysts. TBC the~     international histological classification assumed by the World Health Organisation for~     odontogenic tumours utilizes the term solitary bone cyst, nevertheless the term traumatic~     bone cyst (TBC) is more extensively used in the literature. The WHO classification explains~     TBC as a non-neoplastic osseous lesion because it demonstrates no epithelial lining, which~     differentiates this lesion from the true cysts. There is general conformity that most~     traumatic bone cysts present without symptoms or signs. Seldom, expansion of the cortical~     plate may occur with extraoral swelling, less commonly there may erosion through the~     cortical bone may take place.' Teeth in the area of involved bone usually remain vital,~     without root resorption or tooth mobility. Treatment of traumatic bone cysts has included~     surgical exploration and curettage to motivate bleeding within the bony cavity,' packing of~     the cyst cavity with Gelfoam which has been saturated with thrombin and penicillin, and bone~     grafting based on previous study Injection of autogeneic blood into the bony cavity of a~     traumatic bone cyst was followed by rapid resolution of the lesion.~      Platelet-rich plasma (PRP) is a rich source of growth factors. The growth factors present in~     PRP are familiar, including transforming growth factor-_ (TGF-_1 and TGF-_2), vascular~     endothelial growth factor, 3 isomers of platelet-derived growth factor (PDGF-__,PDGF-__, and~     PDGF-__), and endothelial growth factor. These growth factors are considered to have the~     capacity to accelerate chemotaxis, mitogenesis, angiogenesis, and synthesis of collagen~     matrix and support tissue repair when applied on bone wounds. Due to this high platelet~     content, PRP has been used in orthopaedic surgery, oral implantology, and periodontics with~     the aim of making the repair process as fast and natural as possible, as it can potentially~     afford considerable tissue improvement in bone and soft tissue in a similar way. PRP is~     easily acquired, rich in cell signalling molecules, completely autogenous and can be~     obtained from minimal blood volumes.the purpose of the present study is to determine the~     efficacy of PRP in the treatment of mandibular TBC.~   "
85033|NCT01944397|"~     We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation~     to the development of subsequent stroke, heart failure, and myocardial infarction. We will~     explore the relationship between these outcomes and a range of risk factors.~   "
85034|NCT01944384|"~     Aim of study: The effects of aldosterone blockade on myocardial remodeling in hypertensive~     patients with diastolic failing heart remains unclarified.~      Background: Nearly half of patients with clinical heart failure (HF) have normal left~     ventricular ejection fraction (LVEF) who usually present with apparent diastolic dysfunction~     (DD) and are referred as diastolic HF (DHF). The renin-angiotensin-aldosterone system is an~     established major pathway that is operative in the pathogenesis of HF. The effects of~     aldosterone on myocardial hypertrophy, fibrosis and endothelial dysfunction have clearly~     been established in human and animal models. Furthermore, in these models, aldosterone~     antagonism prevented the development of myocardial fibrosis independent of its effect on~     blood pressure or myocardial hypertrophy. However, its application to patients with DHF is~     unspecified. In the study, we hypothesize that aldosterone blockade could reverse LV~     remodeling process in hypertensive patients with DHF.~      Study protocol: We will enroll medically well-controlled hypertensive patients who have DHF~     defined as the presence of exertional dyspnea or HF signs/symptoms, diastolic dysfunction as~     impaired tissue-Doppler (TDI) derived mitral early annular diastolic velocity (< 8 cm/s),~     and LVEF > 50 % in echocardiography. All patients will be randomized to receive~     spironolactone 25 mg per day or not for at least 6 months. At baseline before randomization~     and 6 months after randomization, we will investigate the Quality-of-life (QOL) score by~     Minnesota Living with Heart Failure questionnaire (Chinese version), echocardiography~     coupled with TDI to assess the degree of LV hypertrophy, myocardial systolic and diastolic~     characteristics. Otherwise, we draw blood sampling at baseline and after randomization for~     quantifying and comparing several biomarkers which are currently proved to be correlated~     with LV hypertrophy, myocardial fibrosis, and biomechanical stretch in DHF patients, such as~     N-terminal pro-brain-type natriuretic peptide, matrix metalloproteinase-2, carboxy-terminal~     telopeptide, procollagen type III amino-terminal propeptide, soluble ST2, and galectin-3.~     Expected results: Aldosterone antagonism is effective for hypertensive patients with DHF by~     improving the quality of life, echo-derived myocardial function, and reducing ventricular~     mechanical stretch through lessening the degree of LV hypertrophy and myocardial fibrosis.~   "
85035|NCT01944371|"~     The purpose of this study is to determine the safety, pharmacology and bioactivity of~     disulfiram in antiretroviral treated HIV-infected adults. The investigators primary~     hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in~     CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).~   "
85056|NCT01944098|"~     The primary objective is to assess the feasibility and safety of administering continuous~     intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y~     Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration~     versus placebo (dextrose administration) (initiated at the time of anesthesia induction and~     continued until extubation) will reduce postoperative narcotic requirements.~   "
85304|NCT01940874|"~     Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to~     decreased cerebral flow and oxygenation in individual patients and this can be detected by~     means of cerebral oxymetry.~   "
85036|NCT01944358|"~     Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes~     of acquisition and risk factors such as men who have sex with men (MSM), sexual workers,~     intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple~     partners. HIV infection rates of up to 50% have been reported among patients diagnosed with~     syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis~     ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an~     increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat~     syphilis is an important issue for public health.~      According to literature review, whether patients with HIV and syphilis co-infection had~     higher serologic failure rate remains controversial, especially in the era after highly~     active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently~     demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected~     patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the~     treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G~     regardless of HIV status; however, it goes on to suggest that some specialists recommended~     additional treatments for HIV-infected patients, namely 3 doses, each a week apart. There~     is no reference and evidence of strength of the suggestion but only specialists' opinion.~      In the study, we aim to compare serologic response of syphilis to penicillin treatment~     between HIV-infected and HIV-uninfected patients and to compare serologic response of early~     syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among~     HIV-infected patients. A longitudinal follow-up of serologic response will be conducted~     after syphilis treatment.~   "
85037|NCT01944345|"~     The registry has been designed as a prospective, observational program for patients~     undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in~     the development of strategic treatment pathways and improved patient care. All patients who~     agree to participate in the registry will sign an informed consent form and subsequently be~     treated by their surgeon with the VariLift device. Potential treatment procedures include~     bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar~     interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar~     spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be~     performed in either an inpatient or outpatient facility. It is anticipated that the VariLift~     devices will improve patient outcomes and lead to the development of treatment pathways to~     improve patient care.~   "
85038|NCT01944332|"~     In this proposed research study, the investigators plan to assess the efficacy of gametes'~     (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo~     development.~   "
85039|NCT01944319|"~     To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a~     population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract~     infection patients.~   "
85040|NCT01944306|"~     Contraceptive failure is the primary cause of unintended pregnancy in the United States.~     With obesity rates at epidemic proportions, any association between obesity and strategies~     that prevent undesired pregnancies constitutes a significant public health and economic~     concern. Evidence from recent epidemiological studies and our preliminary data~     (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest~     that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis~     suggested that a sub-group of obese women, defined by their own birth weight, are at higher~     risk of contraceptive failure. Further studies are necessary to investigate whether birth~     weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for~     the identification of women prone to contraceptive failure. Such an understanding is~     critical to finding a contraceptive strategy with better efficacy for these women.~      The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in~     obese women with low birth weight and compare to obese women with normal birth weight. The~     main hypothesis for this proposal is that an adverse in utero environment programs the~     expression and function of enzymes and transporters that underlie pharmacokinetics of oral~     contraceptives, and leads to contraceptive failure.~      Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8~     lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for~     1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins~     (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol,~     progesterone) will be monitored.~   "
85041|NCT01944293|"~     This study is designed to compare the effectiveness of two medications, Ketamine and~     Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar~     depression.~      The first drug, ketamine, is an experimental antidepressant that early studies have shown~     may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam,~     the comparison drug, is not thought to reduce depression or suicidal thoughts.~   "
85042|NCT01944280|"~     Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on~     the frequency and severity of cramping among hemodialysis patients prone to lower extremity~     cramping during treatment.~      Hypothesis: Compared to control patients, intervention patients will be significantly less~     likely to have intradialytic cramping that requires staff intervention or treatment~     termination.~      This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with~     frequent lower extremity cramps during treatment. Frequent cramping during dialysis~     treatments is defined as 1 or more episodes of lower extremity cramps during or after~     dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes.~     Muscle cramping is defined as contraction of the large muscle group of the lower extremities~     sufficiently painful to require intervention by the dialysis staff for relief.~      The intervention group will receive a 20 minute massage of the lower extremities by a~     trained and licensed massage therapist during each treatment (3x per week) for 2 weeks. The~     control group will receive usual care by dialysis center staff.~   "
85043|NCT01944267|"~     This research study is looking at three different procedures for improving the oral mucosa~     (membrane) around dental implants. The three procedures will be the standard procedure, the~     standard procedure with the use of tissue harvested from the mouth and the standard~     procedure with the use of Mucograft membrane product. An advantage claimed by the Mucograft~     manufacturer is increased patient comfort due to lack of tissue harvesting from the mouth.~     Pain and discomfort levels will be evaluated for each of the procedures. Gain in oral mucosa~     and the visual will also be evaluated.~   "
85044|NCT01944254|"~     The intention of this study is to determine whether the precision of the measure of cardiac~     output can be optimized by conducting the measurement while the participant is instructed to~     exhale slowly. This will be compared to measurements done at random to respiration and timed~     with the participant's spontaneous expiration.~   "
85305|NCT01940861|"~     Vasopressor for current treatment protocols for acute traumatic brain injury can lead to~     vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry~     as a drop in SCO2.~   "
85045|NCT01944241|"~     Over the last 20 years, cervical screening programs have had huge success in reducing~     cervical cancer rates. These programs have done this by screening women at risk of~     developing cancer with regular smear tests. Women with abnormal smears are followed up in~     colposcopy clinics, and where needed, cervical surgery is performed to remove pre-cancerous~     areas on the cervix.~      Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone)~     treatment or cone biopsy. Many studies in the last few years have looked at the impact that~     this necessary surgery can have on the function of the cervix. These studies have mainly~     found an association between LLETZ treatment and an increased risk of preterm labour. There~     have been no large studies investigating the effect cervical surgery may have on fertility.~      The investigators would like to examine the impact that cervical surgery may have on a~     woman's future fertility. It has been postulated that cervical surgery may cause the cervix~     to close, preventing sperm getting through or that it may cause changes in the secretions of~     the cervix, secretions that are necessary for normal interaction with sperm.~      The investigators would like to send a questionnaire to women who have attended colposcopy.~     The investigators will ask these women a series of questions relating to fertility desires~     and divide the women in to two groups depending on whether the women needed cervical surgery~     for pre-cancerous lesions or not.~      Hypothesis: That cervical surgery has an impact on the function of the cervix and on~     fertility.~   "
85046|NCT01944228|"~     The purpose of this study is to assess the effect of transvenous vagus nerve stimulation~     (tVNS) on the immune response.~      In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide~     [LPS]) elicits a systemic immune response with release of pro-inflammatory cytokines, such~     as TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute~     VNS using a minimally invasive delivery method.~   "
85047|NCT01944215|"~     The primary objective of this study is to determine if exercise, fasting, or eating prior to~     the molecular breast imaging study will have an effect on the uptake of the tracer in the~     breast tissue.~   "
85048|NCT01944202|"~     It is well documented that the proportion of inappropriate transthoracic echocardiograms~     (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%.~     Therefore, the potential to improve TTE utilization may be greatest in the outpatient~     setting. However, no study to date has evaluated whether an Appropriate Use Criteria~     (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The~     investigators therefore designed the first randomized control trial of an AUC-based~     educational and feedback intervention aimed at reducing inappropriate outpatient TTEs~     ordered by cardiology and internal medicine physicians in training.~   "
85049|NCT01944189|"~     Despite preventive programs, effective case management is still the cornerstone in malaria~     control.~      This study is as a strategy towards improved recommendations in resource limited countries~     during artemether -lumefantrine (AL) treatment in order to maximize the public health~     benefits.~      This is observational population pharmacokinetics study with a nested comparative~     bioavailability study.The study is intended to describe the variability in lumefantrine~     blood levels among under five year old Ugandan children with uncomplicated falciparum~     malaria receiving current standard artemether-lumefantrine dose regimens. Findings will form~     a basis for development of rational dosage recommendations. The nested comparative~     bioavailability study will explore effect of profiled local food intake (maize porridge plus~     vegetable oil versus milk) on lumefantrine uptake. As a strategy towards improved~     recommendations in resource limited countries during AL treatment in order to maximize the~     public health benefits. As a secondary objective we will correlate the variability in~     lumefantrine uptake to malaria treatment outcome and safety profile in this population.~      Research hypotheses~        1. The population pharmacokinetic profile of lumefantrine among under five year old~          children in Uganda with uncomplicated falciparum malaria is not affected by demographic~          factors.~        2. There is no difference in the bioavailability of lumefantrine when~          artemether-lumefantrine is received with maize porridge plus vegetable oil versus milk~          among under five year old Ugandan children treated for uncomplicated falciparum~          malaria.~   "
85050|NCT01944176|"~     Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is~     steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as~     atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that~     statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD~     patients.~   "
85051|NCT01944163|"~     Rationale: Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting~     up to 24% of young chronic low back pain (CLBP) patients. For general practitioners (GPs) it~     is difficult to distinguish axSpA patients in the large amount of CLBP patients. In previous~     studies a referral rule for axSpA applicable in CLBP patients was developed and validated.~     The next step is to investigate the impact of the referral rule in daily practice. This~     impact analysis will test if the referral rule will be beneficial or harmful.~      Objective: To evaluate the clinical impact of a referral rule in young patients presenting~     at the general practitioners with chronic low back pain, who are at risk for axSpA, compared~     to usual care.~      Study design: A cluster randomized clinical trial. Study population: Primary care patients~     with chronic low back pain, aged 18-45 years.~      Intervention (if applicable): GPs are randomized in clusters either to use directly the~     referral rule or use the referral rule after 4 months. The referral rule consists out of~     four variables, a positive ASAS inflammatory back pain questionnaire, a positive family~     history for spondyloarthritis, a good reaction to NSAIDs (non-steroidal anti-inflammatory~     drugs) and back pain duration longer than 5 years. If at least two out of four variables are~     present a referral to the rheumatologist is advised.~      Main study parameters/endpoints: The primary outcome is a change in the Roland Morris~     Disability Questionnaire (RMDQ) compared to baseline in the CLBP patients with or without~     use of the referral model.~      Secondary parameters: Quality of life measurements, cost-effectiveness, pain and fatigue and~     referral to rheumatologist and diagnosis of axSpA.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The burden and risks associated with participation are minimal. No medical intervention is~     taken place. If the GP of the patients is randomized to the referral model, the patient is~     checked for the risk of axial spondyloarthritis, by the non-invasive referral model. If the~     referral model is positive a referral to the rheumatologist is advised. Is the GP is~     randomized to the 'usual care' there is no difference in the treatment of low back pain than~     nowadays. A GP is still allowed to treat the CLBP patients optimal and a referral to the~     rheumatologist is allowed but not actively advised.~      All participating CLBP patients are asked to fill several questionnaires at four different~     time points, at baseline, after 12 months and after 24 months. In total there are 8~     questionnaires and four separate questions. The questionnaire are designed to fill out by~     the patient themselves. The total time to fill in the questionnaire is estimated to be 30~     minutes.~      The benefits of the study are:~        -  For the CLBP patients, up to 24% of the back pain complaints are caused by axSpA, but~          the GPs are not (yet) aware of this disease. When a CLBP patient is participating in~          this study, the chance of having axSpA as cause for the back pain is investigated. This~          a benefit for a CLBP patients since there is effective treatment for axSpA.~        -  For the GP it is very difficult to distinguish an axSpA patients in the large amount of~          CLBP patients. If it appears that the validated referral rule has an impact on CLBP and~          GPs, the next step will be implementation of this referral model in daily practice and~          it will become a helpful tool for the GP.~        -  For the society, CLBP is a great socioeconomic burden for the society. When one of the~          causes for CLBP, namely axSpA is diagnosed and treated in an earlier stage this will~          lead to a decreased sick leave because of back pain and is therefore potentially~          cost-effective.~   "
85052|NCT01944150|"~     At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with~     chronic pain. Free-drug techniques are available to reduce their consumption of analgesics.~     This study is to assess the relief obtained by the simultaneous combination of these two~     techniques: transcutaneous electrical nerve stimulation and hypnosis.~   "
85053|NCT01944137|"~     The main purpose of this study is to examine changes in patient-reported symptoms during the~     first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer~     (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care~     plus a proactive nursing intervention relative to patients who receive standard care alone.~     Interventions to improve symptom management and prevent urgent care needs in both the clinic~     and hospital for patients receiving chemotherapy with curative intent are needed to enhance~     the quality of cancer care.~   "
85054|NCT01944124|"~     Cardiovascular diseases are the leading cause of death among Canadians. In those with~     diabetes, cardiovascular complications are responsible for more than 70% of deaths. While~     there is much interest in identifying and treating risk factors, the exact biological~     mechanisms, their measurement and optimal ways to prevent and manage them are poorly~     understood.~      Physical activity and regular exercise can prevent diabetes and effectively manage risk~     factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored~     exercise prescribed by a family physician has shown promise as a means to increase fitness~     and reduce risk, but optimal implementation practices remain unknown - especially in rural~     and remote communities with reduced access to healthcare. Mobile health technologies have~     proved to be a beneficial tool to achieve blood pressure and blood glucose control in~     patients with diabetes. These technologies may address the limited access to health~     interventions in rural and remote regions. However, the potential as a tool to support~     exercise-based prevention activities unknown.~      Therefore, this study was undertaken to investigate the effects of a tailored exercise~     prescription alone or supported by mobile health technologies to improve cardiovascular risk~     factors in rural community-dwelling adults at risk for cardiovascular disease and type 2~     diabetes.~      Adults with cardiovascular risk factors were recruited from rural communities and randomized~     to either: 1) an intervention group receiving an exercise prescription and devices for~     monitoring of risk factors with a smartphone data portal equipped with a mobile health~     application; or 2) an active control group receiving only an exercise prescription.~      It was hypothesized that the intervention group would reduce their risk to a greater extent~     than the active control group following 12 weeks, and that these improvements would be~     better maintained in the intervention group at 24 and 52 weeks compared to the active~     control group.~   "
85057|NCT01944085|"~     This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the~     pain score and pulse rate of children who undergo removal of percutaneous pins in the~     outpatient clinic.~      Inclusion criteria:~        -  5-12 years of age~        -  2 or 3 percutaneous pins in either elbow~      Exclusion criteria:~      - documented or suspected allergies to acetaminophen, ibuprofen~      Patients enrolled in the study are instructed not take additional analgesia prior to the~     clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting~     the trial.~      At the clinic visit, they are randomized into one of three groups~      1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).~      They are served the `medication' (weight-appropriate dose) and the pins are removed in the~     clinic an hour later.~      Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately~     following pin removal, and 10 minutes after pin removal.~      The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do~     not decrease pain score and pulse rate associated with the pin removal procedure.~   "
85058|NCT01944072|"~     Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group~     design studied the effect of two aerobic exercise-training intensities in COPD~     patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified~     from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise~     training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010.~     Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler~     dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and~     incremental exercise tests. Patient's allocation sequence was computer-generated, with~     consignment in a safe deposit box.~   "
85059|NCT01944059|"~     The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for~     migraine headaches.~   "
85060|NCT01944046|"~     The purpose of this research study is to learn about the effects of intranasal oxytocin as a~     supplemental treatment for improving social difficulties in children and adolescents with~     autism. This study will also provide additional information about the safety and~     tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social~     motivation, improving daily living skills and quality of life.~   "
85061|NCT01944033|"~     The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already~     established. The purpose of this study is to compare the effectiveness of the β2-agonists~     alone in nebulization with the association β2-agonists + Ipratropium bromide in the~     treatment of an acute exacerbation of COPD consulting the emergency departement based on the~     clinical and the aarterial blood gas.~   "
85062|NCT01944020|"~     Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete~     loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting~     hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality~     including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep~     (SWS). Patients also frequently experience excessive daytime sleepiness (EDS), which, when~     present with OSA, defines the clinical entity OSA syndrome (OSAS). Obesity is the leading~     risk factor for the development of OSA. Interestingly, it has been suggested that the~     disorder itself may contribute to further weight gain, presenting a vicious cycle wherein~     OSA and obesity perpetuate each other. OSAS may promote weight gain by placing patients in a~     state of positive energy balance characterized by low levels of physical activity and~     disrupted patterns of appetite-regulating hormones. Continuous positive airway pressure~     (CPAP), the gold-standard treatment of OSAS, may improve energy balance in these patients,~     although this has not yet been adequately studied. The current proposal will investigate the~     effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with~     moderate-to-severe OSA and EDS. Patients will be instructed to use CPAP at home each night~     throughout the 2-month treatment phases. At baseline and at the conclusion of the 2-month~     treatment phase, the investigators will measure levels of free-living physical activity,~     sleepiness, sleep quality, body composition, cardiovascular risk factors,~     appetite-regulating hormones, hunger, and ad libitum food intake. It is hypothesized that~     active compared to sham CPAP treatment will result in improvements in energy balance,~     including increased physical activity, reductions in abnormally high levels of circulating~     leptin levels, and reductions in hunger, food intake, and cardiovascular risk factors. These~     improvements are hypothesized to be associated with increases in the expression of REM sleep~     and SWS, and reduced EDS as a result of CPAP.~   "
85063|NCT01944007|"~     This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.~   "
85064|NCT01943994|"~     One of the most promising lines of investigation for the therapeutic use of hallucinogens in~     the 1960s and 1970s was in the treatment of drug dependence. We propose to examine~     psilocybin administration combined with a structured smoking cessation treatment program in~     nicotine dependent individuals in order to provide preliminary data on the efficacy of this~     combined treatment for smoking cessation. Prior work in our laboratory has shown that under~     carefully prepared and supportive conditions, psilocybin administration can facilitate~     highly salient experiences with enduring personal meaning and spiritual significance~     (Griffiths et al., 2006, 2008). It is plausible that embedding such highly meaningful~     experiences into a drug dependence cessation attempt may provide an enduring motivation for~     remaining abstinent. Cigarette smoking is a good model system for studying drug dependence~     because users are less likely to be challenged by the many social and economic impairments~     that often accompany dependence on other drugs such as cocaine, heroin, or alcohol. More~     specifically, we propose to conduct a randomized controlled comparative efficacy study in~     which either psilocybin or transdermal nicotine patch are administered under highly~     supportive conditions to individuals who are nicotine-dependent cigarette smokers, who have~     had multiple unsuccessful quit attempts, and who continue to desire to quit smoking. Other~     than nicotine dependence, participants will be healthy. Fifteen participants have already~     completed a preliminary open-label pilot-study with no control condition. Fifty additional~     participants will be enrolled and randomized to either psilocybin (n=25), or nicotine patch~     (n=25) treatment. Participants will receive a 13-week course of cognitive behavioral therapy~     for smoking cessation, with Target Quit Date set for week 5. After several preparation~     meetings with study monitors, participants will have either a single day-long psilocybin~     session using a high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch~     treatment. Participant smoking status will be assessed repeatedly for 8 weeks after the~     Target Quit Date, including biological verification of smoking status through breath and~     urine samples. Smoking status will also be assessed at three follow up sessions~     approximately 3, 6, and 12 months after the Target Quit Date. Additionally, participants~     will undergo MRI scanning before and after Target Quit Date to assess the brain-based~     mechanisms associated with these treatments. Individuals assigned to the nicotine patch~     study treatment condition will be eligible to undergo an optional high dose psilocybin~     session after completing the 6-month follow-up meeting.~   "
85065|NCT01943981|"~     Heart failure and stroke are the two major complication of atrial fibrillation. Current~     treatment for atrial fibrillation is so focused to stroke prevention, but the risk~     assessment for heart failure is less highlighted. The most of patients with atrial~     fibrillation have cardiac functional limitation of variable degree. We hypothesize that the~     exercise test would reveal the subclinical cardiac dysfunction, and might be helpful to~     classify the patients with atrial fibrillation according to their exercise capacity real~     cardiac function.~   "
85066|NCT01943968|"~     The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic~     sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and~     lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic~     sclerosis. The results obtained may help us diagnose these complications of systemic~     sclerosis and hopefully even monitor patient treatment.~   "
85306|NCT01940848|"~     The study shall prove whether treatment of irritable bowel syndrome with Iberogast is~     superior to placebo.~   "
85067|NCT01943955|"~     It is hypothesized that a home-based computer gaming rehabilitation program will improve~     gaze control and balance impairments in those with peripheral vestibular disorders (PVD).~     Ten people with peripheral vestibular disorders were started on a treatment program that~     consisted of playing computer games and while performing various balance exercises. On a~     weekly basis, each participant was contacted by email or telephone and asked to submit their~     computer gaming data to a trained vestibular physical therapist. Following review of this~     data, the physical therapist would contact the participant and progress their computer~     gaming program appropriately. At the completion of twelve weeks of home treatment, the~     participants returned for re-assessment and it was determined that the computer gaming~     program was an effective treatment for those with PVD. It was also determined that a~     monitored telerehabilitation program was an efficient and effective delivery method for this~     treatment.~   "
85068|NCT01943942|"~     The objective of this study was to confirm if two formulations of montelukast tablets are~     bioequivalent.~      Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product~     Singulair (10 mg tablets; Merck Sharp & Dohme). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 32 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
85069|NCT01943929|"~     Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with~     limited number of patients, have proposed the association between nasal septum contact and~     headache. The International Classification of Headaches Disorders proposed specific~     diagnostic criteria for this entity.~      With the major use of CT scans, the contact between nasal mucosa and septum is daily~     observed in many patients without complaint of headache.~      The purpose of this study is to determine if there is any correlation between nasal and~     septum mucosa contact and the prevalence of headache. The investigators hypothesized that no~     correlation will be found using CT scans in a large series of patients.~   "
85070|NCT01943916|"~     Imagio is a multi-modality device, comprised of opto-acoustic (OA) imaging co-registered~     with diagnostic grey-scale (B mode) ultrasound, that has been designed to concurrently~     collect OA images in conjunction with diagnostic grey-scale (B-mode) ultrasound.~      Imagio is expected to identify two functional hallmarks of a potential malignancy: the~     presence of abnormal blood vessels (angiogenesis); and the relative reduction in oxygen~     content of hemoglobin. The technology is non-invasive and does not require any contrast~     agent or radio-isotope, which is required for other modalities such as MRI or PET.~      This is a prospective, single arm, controlled, multi-center, observational study that will~     compare Imagio versus conventional diagnostic ultrasound (CDU) for the visualization of~     suspicious masses.~   "
85071|NCT01943903|"~     The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization,~     and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in~     patients with suspected CAD in order to further inform patients, health care providers, and~     other stakeholders about which technologies are most effective and efficient in the~     diagnosis of CAD~   "
85072|NCT01943890|"~     Background Nebulised hypertonic saline (HS) is an established basic airway clearance~     treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical~     implementation and administration of different HS volumes, including physiotherapy and~     aspects of breathing pattern.~      The aim of the study was to implement standardised and age-adjusted nebulised volumes of~     hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage~     techniques.~   "
85073|NCT01943877|"~     This study was conducted to evaluate by clinical and microbiological parameters the effect~     of locally delivered propolis as an adjunct to scaling and root planing in the treatment of~     chronic periodontitis.~   "
85074|NCT01943864|"~     This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and~     safety of orally administered MEK inhibitor trametinib as the second line in subjects with~     advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary~     endpoint of this study is 12 week non-progressive disease (PD) rate defined as the~     percentage of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK)~     of four tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg~     daily regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese~     population.~      Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose~     of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until~     disease progression or withdrawal from the study treatment, all subjects will receive one~     tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational~     research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers~     for biological activity, and sensitivity or resistance to treatment with trametinib .~   "
85075|NCT01943851|"~     This is an open-label repeat dose, multicenter, 2-part study to determine the maximum~     tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily~     (OD) orally and twice daily (BID) orally. Part 1 of the study is a dose escalation phase to~     select the recommended Part 2 dose (RP2D) based on the safety, PK, and PD profiles observed~     after oral administration of GSK525762. Eligible subjects with relapsed refractory~     hematological malignancies will be enrolled in the OD and/or BID dosing cohorts until a MTD~     is established. Subjects may continue treatment in the study until disease progression,~     unacceptable toxicity, or withdrawal of consent. Part 2 will explore clinical activity at~     the MTD or RP2D; separate expansion cohorts will be planned for acute myeloid leukemia~     (AML), non-Hodgkin's Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc~     and B-Cell Leukemia (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit~     lymphoma]), and multiple myeloma (MM). This is the first study of this agent to be conducted~     in subjects with these relapsed and/or refractory hematological malignancies for which no~     standard therapies are anticipated to result in a durable remission.~   "
85076|NCT01943838|"~     Primary Objective:~      - To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given~     once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.~   "
85077|NCT01943825|"~     The aim of the study is to evaluate a compressed dosing schedule and the immunologic effects~     of co-administration of a flavivirus with JE vaccine.~      Primary Objectives:~        -  To describe and compare the humoral immune response to each of the 4 parental dengue~          virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3, irrespective of~          whether or not JE vaccine has been previously administered.~      Secondary Objectives:~        -  To describe the safety profile after each injection of CYD dengue vaccine.~        -  To describe the humoral immune response to each of the 4 parental dengue virus~          serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered~          with or after JE virus vaccine.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes at six months post-Dose 3 in all four groups and at 12 months~          post dose 3 in Groups 1 and 3 with the compressed schedule.~        -  To describe the JE humoral immune response 28 days after each injection of CYD dengue~          vaccine.~   "
85078|NCT01943812|"~     The aim of this study is to compare two FET protocols by modifying the substituted FET cycle~     in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early~     pregnancy loss.~      Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early~     pregnancy loss.~   "
85079|NCT01943799|"~     This study will evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis~     B (CHB) viral infection who have been virally suppressed with an oral antiviral medication.~     Participants will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.~   "
85080|NCT01943786|"~     Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second~     cause of death from cancer in Spain.~      The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with~     advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the~     application of modern chemotherapy and radiotherapy treatments obtains median survival~     periods of around 24 months, the proportion of patients with advanced disease who obtain a~     cure is low.~      Systemic treatment of advanced CRC has changed considerably in the last ten years with the~     introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most~     commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX),~     Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a~     lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with~     different agents against therapeutic targets, three of which are effective in colon cancer:~     bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or~     panitumumab, which target the epidermal growth factor receptor (EGFR).~      The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and~     the combination of a VEGF and EGFR agents is not beneficial.~      Two recent studies results have identified KRAS mutations as frequent drivers of acquired~     resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions~     indicate that the emergence of KRAS mutant clones can be detected non-invasively months~     before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology).~      Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project~     aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients~     with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with~     first line FOLFIRI-cetuximab~      In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are~     BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms~     of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in~     blood) patients.~      To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected~     in circulating extracellular DNA) at the beginning of treatment, could be of great~     importance for treatment efficacy.~   "
85081|NCT01943773|"~     Purpose: To compare post-operative functional outcomes in patients undergoing preoperative~     functional prehabilitation versus standard of care preoperative management in older adults~     undergoing major elective operations.~      Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions~     of home physical therapy over three weeks) will have improved physical function and reduced~     delirium in comparison to usual preoperative care following major abdominal and thoracic~     operations.~      Specific Aims:~      (#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the~     de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical~     performance battery scores in the control and intervention groups at the preoperative and~     initial assessment timepoints.~      (#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the~     de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical~     performance battery scores in the control and intervention groups at the 60-days~     postoperative and the initial assessment timepoints.~      (#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in~     patients in the control and interventions groups.~      (#4) To compare post-operative complications~   "
85082|NCT01943760|"~     Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute~     pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the~     possibility of postoperative analgesia with fewer systemic adverse effects such as nausea~     and vomiting make the tramadol infiltration a technique of interest. There is controversy~     about its effectiveness.~      The local effect of tramadol in hernioplasty was also studied by researchers with some~     better postoperative analgesia than with local anestetic .~      There are few studies with administration of tramadol for hernioplasty, Which led to the~     interest in this study.~   "
85083|NCT01943747|"~     To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World~     Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an~     international point prevalence study of severe sepsis and septic shock. The goal of this~     project is to determine the world wide burden of severe sepsis and define current practices~     of sepsis care internationally. The study is a simple data collection exercise for patients~     presenting with either severe sepsis or septic shock on World Sepsis Day.~   "
85084|NCT01943734|"~     Objective: To verify the influence of information passed during anthropometric assessment~     would have in physical exercise (PhE) and eating habits of 14 participants (female=11;~     51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of~     FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative~     approach. Were applied, between March and May of 2010, anthropometric evaluation and~     semi-structured interviews. During the evaluation were provided information and guidance on~     health.~   "
85085|NCT01943721|"~     The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and~     efficacy.~   "
85086|NCT01943708|"~     This single-blind randomised crossover trial aims to compare the efficacy of a novel~     Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an~     OSA population, aged over 18.~   "
85087|NCT01943695|"~     The purpose of this study is to compare the effects of aerobic exercise training during and~     after chemotherapy for women who have recently been diagnosed with early-stage breast~     cancer.~   "
85088|NCT01943682|"~     The purpose of this study is to test the safety of a study drug called CPX-351. This drug~     has been tested in adults but not yet in children and adolescents. This study tests~     different doses of the drug to see which dose is safer in children and adolescents.~      Patients who have blood cancer are being asked to take part in this study . Blood cancers~     may include leukemia and lymphoma. Patients able to be in this study have already been~     treated with standard chemotherapy for their disease and the disease is still growing or has~     come back.~      CPX-351 is a drug that is not yet approved by the United States Food and Drug Administration~     (FDA) and is only used in research studies like this one. CPX-351 is made up of two~     chemotherapy drugs that patients may have already received called cytarabine and~     daunorubicin that are now packaged together.~      Another purpose of this study is to collect blood samples for special research studies.~     Researchers want to study how much of the CPX-351 is in the body over time. These studies~     are call pharmacokinetic studies or PK studies for short. PK studies require the collection~     of several blood samples before and after participants are given the study drug.~   "
85089|NCT01943669|"~     In this study, 10 volunteer participants with chronic spinal cord injury will undergo a~     10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a~     lightweight brace-support suit containing motors at the hip and knee joints, rechargeable~     batteries and a computerized control system carried in a backpack. ReWalk™ users control~     their ambulation through subtle changes in centre of gravity and upper-body movements.~     Before, during and after training sessions the volunteers will perform standardised~     assessments and complete questionnaires to assess the functional and psychological effects~     of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and~     psychological outcomes primarily focus on predisposition and perceptions of disability. The~     outcomes of this pilot study will assist the investigators in the preparations of randomised~     controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation~     setting.~   "
85090|NCT01943656|"~     As technologies are advancing quickly in the healthcare setting, new solutions have become~     available helping disable people to enhance their ability to communicate. One of these~     advances is the introduction of the 'eye gaze system'. Through processing eye movements,~     this device allows a person to write, speak, use the Internet and even control systems in~     the home or office. In the currently proposed study we aim to evaluate the psychological and~     functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are~     unable to use arms and legs and sometimes are not able to talk because of an impaired~     respiratory function.~      Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers~     will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions~     required to successfully master the device depends on the learning curve of the patient. The~     progress will be documented accordingly. After successful completion of the training and~     supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised~     use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™~     Eyegaze System by inpatients with tetraplegia results in improved disability perception and~     independence scores. For the current feasibility study 12 participants will be recruited and~     assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and~     'eyeskills' to instruct the computer system. Positive study outcomes will encourage future~     studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home~     environment.~   "
85091|NCT01943643|"~     This is prospective, observational study, that will be conducted in two high-volume~     university interventional cardiology centers. Study population consists of patients with~     true coronary bifurcations (Medina 1.0.1; 0.1.1; 1.1.1) with >50% stenosis in both main~     (MB) and side branch (SB). Patients are scheduled to undergo percutaneous coronary~     intervention (PCI) based on clinical findings. Before PCI, patients will undergo multislice~     CT angiography (MSCTA). MSCTA before PCI for true non left main bifurcation lesions can~     determine atherosclerotic plaque characteristics in MB and SB and predict significant~     narrowing of SB after provisional stenting. Primary goal is to determine which plaque~     characteristics of true non left main bifurcation lesions in MB and SB, as assessed by~     MSCTA, can affect the occurrence of SB ostial compromise after provisional stenting.~     Patients will be seen in the office visit at 1, 3, 6 and 12 months after the procedure.~     Clinical evaluation and 12-channel ECG are mandatory at each visit. Comprehensive~     echocardiogram with 2D-strain analysis will be done at 3-month visit. Repeated coronary~     angiography will be done at 6-month visit, and will include quantitative analysis of~     previously treated bifurcation lesion.~   "
85092|NCT01943630|"~     The purpose of this double blind study is to determine whether topical 15% AS101 gel is~     effective and safe as compared to vehicle in the treatment of external genital warts in~     women.~   "
85093|NCT01943617|"~     Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver~     cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the~     other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year,~     entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every~     six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan;~   "
85106|NCT01943448|"~     Visual impairment in high myopic eyes is mainly due to the different types of myopic~     maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal~     neovascularization. Macular hemorrhage was one of those complications. Despite choroidal~     neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal~     microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple~     hemorrhage is generally good. However, some patients had persistently poor vision after the~     absorption of the hemorrhage. In the literature, the visual prognosis in those patients was~     reported to be associated with the microstructure change under the optical coherent~     tomography (OCT) or the presentation of the autofluorescence. The investigators will collect~     the patients with high myopia and presenting with macular hemorrhage. High resolution OCT~     and autofluorescence imaging will be used to analyze the change of the microstructure of~     retina and its correlation with the visual prognosis.~   "
85307|NCT01940835|"~     This purpose of this study is to determine if activation of a person's immune system in the~     small intestine could be a contributing cause of Type 1 Diabetes.~   "
85094|NCT01943604|"~     This study is designed to examine healthy children who skip breakfast and the effects of~     fasting on their neuropsychological functioning and the potential benefits that a Balanced~     Breakfast may have on their learning abilities. It is expected that this study will provide~     new knowledge on how prolonged periods of 8 or more hours without food affect neurocognitive~     processes and thus learning how specific meals following this period of fasting, which most~     children experience, change those processes, potentially for the better.~      The hypotheses for this study are:~        1. Children who consume breakfast will demonstrate significantly higher levels of~          attention, greater concentration, and diminished impulsivity compared to children who~          do not consume breakfast.~        2. Children who consume breakfast will demonstrate a significantly quicker reaction time~          and increased accuracy in correctly identifying target stimuli from an array compared~          to children who do not consume breakfast.~        3. Children who consume breakfast will demonstrate increased freedom from distractibility~          and enhanced short-term memory compared to children who do not consume breakfast.~        4. Children who consume breakfast will demonstrate increased cognitive processing speed~          compared to children who do not consume breakfast.~        5. Children who consume breakfast will have improved verbal learning compared to children~          who do not consume breakfast.~        6. Children who consume breakfast will have improved visual memory compared to children~          who do not consume breakfast.~   "
85095|NCT01943591|"~     Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of~     intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has~     been associated with incomplete occlusion at initial treatment (remnant) or at follow-up~     (recurrence). This in some studies has been as high as 20%. While many such aneurysm~     remnants or recurrences exhibit benign behavior, many require retreatment to prevent future~     hemorrhage.~      A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2~     and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical~     outcome when treated with hydrogel-coated coils, an improvement inferred to result from~     higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is~     associated with technical difficulties related to expansion and limited time for deployment.~     The investigators theorize that similar results could be achieved by using more voluminous~     bare platinum coils, leading to improved packing density compared to smaller caliber coils,~     and thus result in lower incidence of remnants or residuals. The relationship between~     packing densities and composite clinical endpoints having never been shown in a robust~     fashion, the investigators therefore propose a randomized clinical trial opposing coiling~     with soft 15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size~     from 3 to 9.9 mm.~      To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber~     coils in achieving better composite outcomes, the investigators propose the DELTA trial:~     Does Embolization with Larger coils lead to better Treatment of Aneurysms trial, a~     randomized controlled blinded trial with 2 subgroups of 282 patients each, 564 total:~      Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow~     Subgroup 2: Coiled with 10-caliber coils.~   "
85096|NCT01943578|"~     The study examines the physical capacity of lung cancer patients assessed with the six~     minute walk test and handgrip strength. Demographic and selfreported exercise behavior is~     registered to explore correlations to functional and physical capacity.~      Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an~     expected average of 12 weeks between first and second assessment.~   "
85097|NCT01943565|"~     Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain~     medications called opioids, such as morphine, are given through the vein or into the muscle.~     However, a more effective way to give pain relief with fewer side effects (such as nausea~     and slowing your breathing) is to give opioids in the spinal space as part of the~     medications given for a cesarean delivery.~      For many years, the opioid of choice was morphine due to its long anesthetic effect and~     acceptable side effect profile. A nation-wide disruption in the supply of preservative-free~     morphine has made it necessary to look for alternatives. Many institutions worldwide have~     used another opioid, called hydromorphone, in the spinal space for over a decade. This drug~     has a very good safety and side effect profile and has been used at our institution for more~     than a year. Of interest, while a number of different doses of hydromorphone have been used,~     there have been very few studies to evaluate the best dose for providing good pain relief~     with minimal side effects. The goal of this study is to find the best dose of spinal~     hydromorphone for women undergoing cesarean delivery.~   "
85098|NCT01943552|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre~     trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese~     peri-operative patients with COPD under general anaesthesia.~   "
85099|NCT01943539|"~     A study in ADHD and neuro-typical children to assess EVO game play over 29 days.~   "
85100|NCT01943526|"~     The objectives of this study are to assess the long-term safety and impact on disease~     activity and progression of natalizumab (Tysabri) in participants with relapsing remitting~     multiple sclerosis (RRMS) in a clinical practice setting.~   "
85101|NCT01943513|"~     The primary objective of this study is to determine whether muscle atrophy induced by~     immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers.~     The secondary objectives of this study in this study population are:~        -  To determine whether muscle weakness induced by immobilization of the lower limb can be~          attenuated by BIIB023~        -  To assess the effect of BIIB023 on the recovery of muscle mass and strength after~          immobilization~        -  To assess the effect of BIIB023 on histological markers of muscle atrophy and~          regeneration~        -  To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism~          recovery kinetics~        -  To evaluate the safety and tolerability of BIIB023~   "
85102|NCT01943500|"~     Objective: To test the sensitivity of a proprietary novel filtration device designed to~     capture and concentrate circulating tumor cells (CTCs).~   "
85103|NCT01943487|"~     This study investigates the effect of the co-administration of verapamil on the steady-state~     pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet,~     EC905.~   "
85104|NCT01943474|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt peripheral IV placement, higher completion of therapy, fewer~     complications, longer dwell times and higher user satisfaction compared to Conventional IV~     Catheters.~   "
85105|NCT01943461|"~     This is a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting~     programmed death ligand 1 [anti PD-L1]) in Japanese subjects with metastatic or locally~     advanced solid tumors, followed by a consecutive expansion part in Asian subjects with~     gastric cancer.~   "
85148|NCT01942902|"~     The purpose of this study is to evaluate the system performance of the GlySure Continuous~     Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.~   "
85107|NCT01943435|"~     BACKGROUND: Lumbar spinal stenosis - known by patients as arthritis of the spine - is a~     condition that is very common; found in about 30% of older adults. It is the most common~     reason for people over the age of 65 to have back surgery. Some patients with stenosis do~     not need back surgery and can be treated with other methods, such as physical therapy,~     chiropractic, exercise, and medication. But we just don't have enough good research to tell~     us which treatment works best for which patient and under which circumstances. This research~     study hopes to provide more information about the effectiveness of the various non-surgical~     choices for managing stenosis.~      OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical~     treatment approaches for stenosis:~        1. Usual medical care that involves prescription medications and/or spinal injections~          (epidurals)~        2. Group exercise in supervised classes given in a community center setting~        3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by~          physical therapists and chiropractors~      METHODS: This research study will involve 180 adults who are at least 60 years old and have~     been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into~     three groups, each group receiving one of the 3 types of treatments listed above under~     Objectives. The determination of which type of treatment each person receives will be~     determined by chance, using a computerized version of flipping a coin. This is a process~     known as randomization, which scientists think reduces the bias in research studies. A~     series of tests and questionnaires will be given to the patients before and after they get~     treatment and comparisons will be made to see how much improvement they made with each of~     the types of treatments. Finally, the researchers will compare the differences between the 3~     treatment groups to see if certain types of treatment produced better results than others,~     and if there were any examination findings that could be used to predict which type of~     patient would do better with which type of treatment.~   "
85108|NCT01943422|"~     This is a dose-seeking and efficacy study of combined BRAF Inhibitor Vemurafenib and~     High-dose Interferon alfa-2b for therapy of advanced melanoma.~   "
85109|NCT01943409|"~     Intravenous nutrition is an important therapy for the recovery of many patients. It is~     indicated when the patients cannot take food by mouth or use their intestines for feeding.~     It is important to indicate it in the appropriate setting because it's not free of~     complications and is a costly treatment. Some of the complications are: elevated blood sugar~     or lipids, elevated liver function tests, infection of the catheter or device used to~     administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids,~     carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a~     soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of~     nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved~     by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals~     to evaluate the quality of intravenous nutrition administered to hospitalized patients in~     terms of: assessing indications, prescription, complications, clinical results and costs.~     The objective of this study is to determine if intravenous nutrition prescribed in~     hospitalized patients is indicated following existing guidelines in terms of timing of~     nutrition support, prescription, monitoring and whether it is associated with complications.~     In addition, length of stay and mortality will be assessed. Also, we will evaluate~     nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based~     lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid~     emulsion (ClinOleic).~   "
85110|NCT01943396|"~     In this research rheohemapheresis will be used for the treatment of patients with high-risk~     dry form of age-related macular degeneration. Correction of rheologic parameters and~     activation of retinal functional reserves after the therapy will positively influence~     functional condition of retina. The newest special electrophysiologic methods will be used~     to determine retinal changes in time. The investigators will also evaluate some important~     immunologic factors and complement changes as well as define indication criteria more~     precisely.~   "
85111|NCT01943383|"~     Patients enrolled in this study will have completed one of the parent studies~     Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR-1 or PEAR-2) evaluating how~     well their blood pressure was controlled by medication. Patients in the current study will~     provide a single tube of blood which will be used to create adult stem cells that can be~     converted into other cell types, like heart or vasculature. Patients will not be asked to~     return for any follow up visits.~   "
85112|NCT01943370|"~     Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic~     sinus surgery. However, the ideal timing and quantity of irrigation in the early~     post-operative period remains unknown. Proposed benefits of early, large volume irrigation~     include removal and softening of crusts, resulting in improved mucociliary clearance. The~     potential benefit of early large volume saline irrigation on post-operative day three to~     ease or reduce the need for early post-operative debridement has not been studied.~   "
85113|NCT01943357|"~     The study will help determine if the Better Choices Better Health Diabetes program~     (community-based or online, also known as the Diabetes Self-Management Program) improves the~     hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms~     (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy~     behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot,~     kidney and cholesterol exams; and activity), 3) the use of health care services. This~     project is a translational study to demonstrate the effectiveness of the intervention in the~     context of a major insurer.~   "
85114|NCT01943344|"~     The purpose of this Clinical Investigation is to gather feasibility data on the clinical use~     of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to~     percutaneously close femoral arterial puncture sites in the range of 18-24 F, post~     endovascular procedures.~   "
85115|NCT01943331|"~     The current protocol desires to implement a large-multicenter observational study of~     hospital acquired infection in ICU in China. The study will generate data on generate data~     about the epidemiology current management of nosocomial infection.~   "
85116|NCT01943318|"~     Liver cirrhosis represents a worldwide health problem and is a major cause of mortality.~     Cirrhosis is the common end for chronic alcohol abuse and hepatitis C and B virus~     infections. Patients who have cirrhosis have varying degrees of compensated liver function,~     and clinicians need to differentiate between those who have stable, compensated cirrhosis~     and those who have decompensated cirrhosis. It is shown various complications: portal~     hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc.~      Thus, it is important to have this information to manage disease and determine specific~     therapy. However, register-based studies in have not been reported in Korea.~      The goal of this study is to describe the natural history of a large number of patients with~     liver cirrhosis prospectively followed, and to identify predictors of the occurrence of~     Hepatocellular carcinoma.~   "
85329|NCT01940549|"~     The purpose of this study is to test whether transcranial direct current stimulation (tDCS)~     can enhance the clinical efficacy of trauma-focused therapy for posttraumatic stress~     disorder.~   "
85117|NCT01943305|"~     Epidemic viral diseases have become more prevalent in recent years. Among the various~     strategies to prevent such epidemics, vaccination is the most cost-effective. However,~     populations that are immunized are typically already exposed to multiple previous~     vaccinations or natural infections. Studies from this and other laboratories have revealed~     that pre-existing dengue antibodies can either inhibit or enhance subsequent dengue~     infection depending on the pre-existing antibody levels. While cross-reactive antibody is~     potentially pathogenic in dengue, how it impacts immune response to vaccination is unclear.~     Indeed, aggregated at the site of vaccination and the respective draining lymph nodes are~     antigen-presenting and immune regulatory cells that express Fc receptors and play pivotal~     roles in determining the magnitude and polarity of the immune response. Vaccine uptake by~     these antigen-presenting cells may thus be either inhibited or enhanced when vaccines are~     opsonized with cross-reactive antibodies.~      In view of the limited knowledge on how cross-reactive antibodies affect vaccination~     outcome, investigators propose here a study that exploits the known cross reactivity between~     Japanese encephalitis (JE) virus antibody and yellow fever (YF) vaccine. Investigators~     hypothesize that cross-reactive antibodies impacts antibody response to YF at the point~     vaccination in a concentration-dependent manner by altering both vaccine uptake and the~     innate immune response by antigen presenting cells. Investigators will structure an open~     label clinical trial on sequential vaccination with JE and YF vaccines, with different time~     intervals between vaccinations. This would test immune response to YF vaccination in~     subjects with different titer of cross-reactive JE vaccine-derived antibodies.~   "
85118|NCT01943292|"~     This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal~     adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The~     purpose of this study is to assess the safety (including the recommended phase 2 dose), the~     pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).~   "
85119|NCT01943279|"~     Background: Medical abortions in Canada are provided using a standard regimen of~     methotrexate and misoprostol. After these medications are administered, patients are most~     commonly checked for termination of the pregnancy with an ultrasound and physical~     examination at an in-clinic follow-up appointment. These follow-up appointments can be~     inconvenient, costly, and take away from patient privacy. Furthermore, it has been suggested~     that these follow-up appointments may not be necessary for patients.~      Objective: To determine whether remote follow-up, using telephone and blood testing is a~     feasible, safe, and effective method of follow‐up after medical abortion, compared to~     standard care that requires an in-clinic visit and ultrasound.~      This study offers women the option of remote follow-up by telephone combined with serum~     Beta-human chorionic gonadotropin (β-hCG) testing or standard in-clinic follow up. We will~     determine women's preferences for follow up, and compare adherence to the follow-up~     schedule, number of clinical contacts, and outcomes of the abortion. This study will be~     performed at two clinics in Toronto, the Bay Centre for Birth Control (BCBC) and the Choice~     in Health Clinic (CIHC).~      Primary Hypothesis: Follow-up will be more successful with RFU, compared to SFU.~   "
85120|NCT01943266|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the~     nitrogen balance method have been well described. Importantly, nitrogen balanced~     underestimates requirements.~      The current dietary reference intakes (DRI) requirement for healthy adult males is based on~     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was~     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of~     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using~     indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young~     men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by national health and nutrition examination survey (NHANES), the authors~     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0~     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending~     on the calculations used for ideal body weight some older adults could be getting higher or~     lower than requirement. There is no scientifically derived protein estimate for older~     adults. Therefore there is a need to measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of male elderly~     subjects between the ages of 65 - 75 years using the IAAO technique.~   "
85121|NCT01943253|"~     1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use~          of a new water-jet assisted ESD system using the HybridKnife® in patients with early~          gastric neoplastic lesions in comparison to the conventional ESD established in Japan.~          The water-assisted ESD technology allows pressure controlled injection of fluids~          through the tip of a recently developed HybridKnife®. Submucosal injection,~          circumferential cutting and dissection of lesions as well as coagulation of bleeding~          can be performed with the same device without need for changing the instrument. These~          options should accelerate the procedure and may increase its safety and efficacy.~        2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the~          advantage of less instrument changes due to the combination of high-frequency cutting~          and water-jet application in one single instrument. This should lead to a simplified~          ESD procedure, shorter learn-ing curve and especially to a shorter procedure time.~      The water-jet assisted ESD technique should be shorter than the conventional ESD techniques~     using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.~   "
85122|NCT01943240|"~     Our routine practice for patients undergoing mastectomy is to include paravertebral~     peripheral nerve blockade for postoperative analgesia. This study investigates whether the~     addition of another nerve block targeting the pectoral nerves will improve that analgesia.~   "
85123|NCT01943227|"~     This is a single site, prospective, non-blinded, non-randomized, non-interventional study~     designed to evaluate the effect of changes in alveolar minute ventilation on the measurement~     of respiratory heat loss (enthalpy).~   "
85124|NCT01943214|"~     By analyzing the relationship between the body constitution and the progression of Type II~     diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to~     provide an useful tool, body constitution, to stratify the patients accordingly for~     individualized health care.~   "
85125|NCT01943201|"~     Introduction:~      It is known that people with spinal cord injury (SCI) bear a considerably increased risk of~     developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk~     factors. It was the aim of the study to examine the effects of a specially developed~     low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients~     with SCI.~      Method:~      Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be~     recruited. Each patient spends five consecutive nights on the new, respectively,~     conventional bed sheet. After the five nights, patients are asked to complete a linear~     questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition,~     the patients are examined daily while still fasting, for skin redness, skin moisture, skin~     elasticity and skin blood circulation in the parasacral region.~   "
85126|NCT01943188|"~     This pilot phase I trial studies the side effects and best way to give stereotactic body~     radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer.~     Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by~     stopping them from dividing or killing them. After treatment, stem cells are collected from~     the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the~     stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the radiation therapy.~   "
85127|NCT01943175|"~     This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining~     stem cells which is derived from adipose cells of subjects with heavy genetic loading for~     schizophrenia then differentiating them into neuronal cells.~   "
85128|NCT01943162|"~     This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic~     Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation~     principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART)~     intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy~     of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and~     treatment compliance in those with a history of mild to moderate TBI and persistent~     cognitive complaints.~   "
85129|NCT01943149|"~     The purpose of this study is to monitor outcomes of total hip arthroplasties performed with~     E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing~     surface in total joint replacements for half of a century. Radiation, the most common form~     of sterilization, unfortunately it results in the creation of free radicals (atoms or~     molecules that cause chemical reactions with other substances) within the materials which~     cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis~     E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free~     radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and~     long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear~     rates after being placed in a patient.~   "
85130|NCT01943136|"~     This study will be an investigator-blinded, patient-blinded, assessor-blinded,~     parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week~     twice-daily application of topical papaya leaf extract ointment compared to mupirocin~     ointment in achieving clinical cure among patients with impetigo.~   "
85131|NCT01943123|"~     This study was conducted to assess the effects of commercially available probiotic drink on~     the number of salivary mutans streptococci in school going children, aged 12-14 years in~     Bangalore city in India~   "
85132|NCT01943110|"~     The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery~     devices can safely and precisely inject liquid into the intradermal layer of the skin in~     three different injection locations~   "
85133|NCT01943097|"~     Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC)~     activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by~     (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and~     (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and~     follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and~     clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors.~      METHODS:~      Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at~     initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of~     (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET,~     using tumor histology as the standard.~   "
85134|NCT01943084|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate the bioequivalence (the expected biological equivalence of two pharmaceutical~     drug products with identical active ingredient) of Norditropin® (somatropin) versus~     Genotropin® (somatropin) in healthy adult subjects.~   "
85135|NCT01943071|"~     Attending day care centres with programs specifically designed for patients with dementia is~     believed to postpone admittance to nursing home as well as increase quality of life and~     well-being for both patients and their family caregivers. We aim to investigate to what~     degree attendance in day care centres with programs for people with dementia is effective~     for patient and their caregivers whilst also cost efficient for society. The study consists~     of a quasi-experimental trial with comparison group. 400 patients with dementia, along with~     a family caregiver, will be included in the trial. Effects will be measured at baseline,~     after one and two years. Data collection will be made at three levels; at patient level with~     measures of cognition, depression, quality of life, functioning in activities in daily~     living, neuropsychiatric symptoms and death; at caregiver level with measures of depression,~     level of burden and quality of life; and at societal level with measures of nursing home~     admittance, hospital stays and use of other health resources. Additionally,a qualitative~     interview study will include 20 dyads from the main trial. The main focus will be on how~     attending day care centre programs for patients with dementia affect the lives of both~     patients and caregivers. Five of these dyads will be followed closely throughout the~     participation period to be used as case examples.~   "
85149|NCT01942889|"~     On the basis of published data and investigators results indicating that systemic redox in~     balance may contribute to the peripheral muscle dysfunction in COPD patients, the~     investigators propose a study testing the effects of antioxidants and exercise training in~     COPD patients. The results may have major implication in the improvement of pulmonary~     rehabilitation benefits~   "
85136|NCT01943058|"~     This randomized phase II trial studies how well megestrol acetate or~     levonorgestrel-releasing intrauterine system works in treating patients with atypical~     endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of~     endometrial cancer cells. Hormone therapy using megestrol acetate or~     levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the~     amount of progesterone the body makes. It is not yet known whether megestrol acetate is more~     effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial~     hyperplasia or endometrial cancer.~   "
85137|NCT01943045|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282~     in patients with Type 2 Diabetes.~   "
85138|NCT01943032|"~     The purpose of this study is to determine discordant hormonal status of primary breast tumor~     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer~     patients.~   "
85139|NCT01943019|"~     Approximately one third of patients with schizophrenia show a poor response to standard~     treatment with antipsychotic medications. This treatment resistant group of patients~     represents a major challenge in everyday psychiatry, and consumes a disproportionate amount~     of time from the clinicians, resulting in considerable costs to the society and government.~     Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered~     in patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We~     postulate that this may play a role in the neuropathology of schizophrenia patients and by~     inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be~     able to improve and even ameliorate the symptoms of schizophrenic patients. However, until~     now there have yet any studies on the potential of these inhibitors in schizophrenia~     patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor,~     linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment,~     which will establish the feasibility of a larger trial.~   "
85140|NCT01943006|"~     Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid~     cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment~     is continued after the end of infusion for at least 7 days.~      Number of patients developing superficial phlebitis and duration of phlebitis will be~     recorded.~   "
85141|NCT01942993|"~     Approximately 40-60 % of cutaneous melanomas select for a mutation in a protein called BRAF~     which is part of a signaling pathway called the Mitogen Activated Protein Kinase (MAPK)~     pathway. When BRAF is mutated the MAPK pathway remains active allowing for melanoma to grow.~     Vemurafenib is an oral treatment which blocks the activity of BRAF which leads to decreasing~     the activity of the MAPK pathway. When patients with melanoma expressing specific mutation~     in BRAF are treated with vemurafenib approximately 50% will develop a response to treatment~     with shrinkage of tumor. When compared to a standard chemotherapy called dacarbazine used to~     treat melanoma, treatment with vemurafenib leads to a statistically significant overall~     survival or living longer benefit. Because of this survival benefit vemurafenib was Food and~     Drug Administration (FDA) approved for the treatment of metastatic melanoma expressing a~     BRAF mutation called V600E BRAF. There is increasing evidence that the immune system can~     also be important in affecting melanoma growth and survival and there are immune treatments~     FDA approved for the treatment of metastatic melanoma. There is some limited evidence that~     blocking BRAF with vemurafenib may affect the activity of components of the immune system.~     It is important to better characterize and understand the effects of vemurafenib treatment~     on various components of the immune system. The purpose of this study is to systematically~     evaluate the effects of vemurafenib treatment (at FDA approved dosing regimen) on parts of~     the immune systems called the innate and adaptive immune systems. The hypothesis is that~     vemurafenib treatment will affect the immune system.~   "
85142|NCT01942980|"~     The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the~     improvement in the control of systemic disease, and due to an improved detection through~     imagery.~      The treatment management of single BM remains controversial. Indeed, even though it is~     widely accepted that local treatment increases the median survival time in patients having a~     good prognostic status, the adding of adjuvant whole-brain radiation therapy (WBRT) is~     currently subject to controversy, due to its potential toxicity. Yet, two randomized trials~     have demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic~     origin in case of absence of adjuvant WBRT, without change in overall survival (but~     overall survival was not a primary endpoint in any of these studies).~      The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes~     controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that~     the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in~     the subgranular zone of the dentate gyrus, has an essential role in the development of these~     brain dysfunctions.~      It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm~     expansion) is low, in the range of 8,6%.~      New irradiation techniques, in particular intensity-modulated radiotherapy associated with~     rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the~     while distributing an adapted dose to the remaining brain.~      This prospective, randomized study, will compare, through a battery of neuropsychological~     tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal~     avoidance by intensity modulated radiotherapy, in patients presenting with a single operated~     brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant~     improvement in cognitive function, this radiotherapy scheme could become the standard~     postoperative treatment to be proposed to patients presenting the best prognostic factors.~     This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on~     intra-cerebral control.~      Justification of evaluation criteria :~      Principal criteria :~      Evaluation criteria to assess cognitive toxicity have been selected on the basis of the~     recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate~     memory, verbal function, visual and motor coordination, and executive function. The selected~     tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning~     Test Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A~     and B (Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on~     the HVLT-R test, as memory is thought to be the most frequently affected domain.~      The tests will be performed before treatment (baseline cognitive function), at 4 months~     and at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not~     answering will be noted.~      Secondary criteria :~      Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival~     (PFS) Overall survival.~   "
85143|NCT01942967|"~     The purpose of this study is to examine the blood flow and the delivery of oxygen to the~     brain and gut in preterm babies while they are supported with two modes of breathing machine~     and compare these two methods to see if one allows for better blood flow to the brain and~     gut.~   "
85144|NCT01942954|"~     The consequences of alcohol dependence are severe and may range from physical diseases to~     neuropsychological deficits in several cognitive domains. Alcohol abuse has also been~     related to brain dysfunction specifically in the prefrontal cortex. To assess these deficits~     and the application of a novel approach of cognitive stimulation to alcoholics, we have~     carried out a neuropsychological intervention program with mobile health technology.~     Patients diagnosed with alcohol dependence syndrome were submitted to cognitive stimulation~     during four weeks in a three-day/week basis.~   "
85145|NCT01942941|"~     A study to see what effect the geko™ device has on blood flow in patients with lower limb~     vascular disease.~   "
85146|NCT01942928|"~     Background Excessive Crying (Infantile Colic) is one of the most common complaints for which~     parents seek treatment. These otherwise healthy and well fed infants show no signs of~     failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.~      Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that~     investigates the effectiveness of cranial osteopathy in addition to usual National Health~     Service (NHS) care in infants with colic.~      Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in~     private practice and NHS health visitors. Parents of 60 excessively crying infants/infants~     with colic will be recruited by NHS health visitors. Infants will be included into the study~     if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive~     crying/infantile colic, and have no co-morbidities. Participants will be randomised into the~     usual NHS care group or the usual NHS care plus cranial osteopathic intervention group.~      Usual NHS care will be provided by health visitors and osteopathic treatment will be carried~     out by experienced osteopaths in private practice.~      Primary outcome measures are acceptability and feasibility of intervention procedures.~     Furthermore, changes in the frequency and duration of crying will be documented in a daily~     crying diary. Parental quality of life will also be assessed.~      This pilot investigation will provide useful information in order to further develop and~     adapt the current interventions and trial procedures with a view to a full-scale randomised~     controlled trial.~   "
85147|NCT01942915|"~     This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells~     transplantation in liver cirrhosis patients.~   "
85150|NCT01942876|"~     The proposed study will address the critical need to reduce illegal drug use, in particular~     drug use, and the occurrence of drug-related harm in low-income racially diverse patient~     populations at urban primary care safety-net clinics. Since they are at risk for accelerated~     trajectories to drug dependence once drug use begins, low-income racially diverse~     populations pose particular concern for public health policy makers and drug-use prevention~     efforts. The study will be the first to standardize drug screening and primary-care~     clinician delivered brief intervention among racially diverse at risk drug users, that is~     users with casual or frequent use without the physiological or psychological manifestations~     of dependence, to reduce their 'at risk' use of drugs, and it may effectively interrupt~     their pathway to dependence.~   "
85151|NCT01942863|"~     Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE)~     and spiral enteroscopy (SE) currently, have shown good performances in small bowel~     diagnostics and seem to be useful in the clinical routine. However, enteroscopy is a~     time-consuming procedure. During common practice, large volumes of air need to be~     insufflated for good visualization. It leads to significant distention of the small bowel~     during the examination, which makes further intubation more technically challenging because~     of the formation of distended bowel loops and acute angulations and limits the maximal~     intubation length. According to the published data, the oral insertion depth of different~     kinds of enteroscopy is limited to approximately 240 cm. The total examination rate range~     form 18% to 86% for DBE and 0% to 11% for SBE.~      It is thought that the intubation depth in small bowel determines the diagnostic yield and~     the following treatment. The deeper the enteroscopy is advanced into the small bowel, the~     more lesions may be found and treated. In order to improve the intubation depth of balloon~     enteroscopy, several methods, such as carbon dioxide insufflation and decompression side~     tube-equipped device, have been tried and showed positive effects. CO2 insufflation could~     also reduce severe pain during DBE and residual gas retention after the procedure because of~     rapid absorption. However, it is not known how much CO2 insufflation can decrease the~     distention of small bowel and the formation of bowel loops.~      Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate~     completion of colonoscopy, even in potentially difficult patients with prior abdominal or~     pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the~     formation of acute angulation, which may cause less pain and easier intubation during scope~     insertion. Recently, water exchange method was also tried in two patients undergoing SBE via~     antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached~     respectively (unpublished data), indicating water exchange be a useful method for deep~     intubation of SBE.~      Here a prospective, randomized, controlled trial was designed to investigate whether,~     compared with CO2 insufflation method, water exchange method could increase the intubation~     depth and diagnostic yield in patients undergoing SBE.~   "
85152|NCT01942850|"~     The project will collect information on the mapping of clinical ratings on a number of~     scales that are used in the assessment of patients with ataxias.~   "
85153|NCT01942837|"~     This research study is evaluating a drug called enzalutamide in metastatatic castration~     resistant prostate cancer.Enzalutamide is already FDA approved for metastatic castration~     resistant prostate cancer after treatment with chemotherapy. The purpose of this study is to~     analyze features of tumor specimens sampled prior to therapy and at disease progression to~     determine why patients respond or stop responding to treatment with Enzalutamide. Prior~     chemotherapy is not a requirement of this trial. Enzalutamide is a drug designed to block~     the effects of male hormones in the body that may be helping prostate cancer to grow. It has~     already been approved by the FDA (the U.S. Food and Drug Administration) for patients with~     castration-resistant prostate cancer who have received prior chemotherapy.~      Additionally, this study will analyze features of tumor specimens sampled prior to therapy~     and at disease progression to determine why patients respond or stop responding to treatment~     with enzalutamide.~   "
85154|NCT01942824|"~     Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations~     annually. While vaccination is the cornerstone of preventing influenza infection,~     vaccination coverage in adults is low with only 35% vaccinated by end of November. Latino~     adults have the lowest coverage rates. Text message reminders have been used successfully~     for improving influenza vaccination for children. This study will assess the use of text~     messaging to improve influenza vaccination coverage rates in a largely minority, publicly~     insured adult population.~   "
85155|NCT01942811|"~     The goal of the US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT) is a~     multi-site study conducted in the US (East Los Angeles) and Mexico (Tijuana) which aims to~     reduce drug demand on both sides of the border. The study also aims to build a collaborative~     partnership between the US and Mexico research teams. The Bi-National QUIT Study will~     conduct a randomized control trial for risky drug use in several Los Angeles area community~     health centers. The intent of the trial is to interrupt the progression to addiction for the~     casual and occasional users of illicit drugs and non-medical users of pharmaceuticals. The~     Bi-National QUIT protocol will include (1) a computerized assessment of the patient's~     drug-use history (2) very brief (<5 minutes) clinician advice during a patients pre-arranged~     medical visit which will be preceded by a computerized assessment of the patient's drug-use~     history (3) a post visit assessment and video doctor (repeating the very brief clinician~     advice) in the waiting room (4) two post-visit telephone drug-use counseling sessions to be~     conducted by drug-health educators at approximately 2 and 6 weeks after the start of the~     intervention. Follow-up assessments will be conducted at 3 months post-randomization.~     Parallel activities will take place in the U.S./Los Angeles sites and Mexico/Tijuana sites.~     Data will be shared between both teams. Data analysis will be collaboratively conducted by~     both teams.~   "
85156|NCT01942798|"~     WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to~     improve walking capacity in individuals with either a unilateral below-knee or above-knee~     amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK~     program in older (50+ years) community living adults with lower limb amputations (LLA).~      Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with~     improvement in functional walking capacity, compared to the control group who will only be~     playing cognitive games. Secondarily, a functional walking capacity will also include an~     improvement in lower extremity strength and balance, inter-limb gait symmetry, balance~     confidence along with participation in daily and social activities, locomotor capabilities~     and an increase in physical activities.~   "
85157|NCT01942785|"~     To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a~     naturalistic setting of depressed patients with irritability.~   "
85158|NCT01942772|"~     Ankle rehabilitation training becomes a tough question for the patients with ankle joint~     injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot~     orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric~     motor is proposed in this paper. The mechanical structure of the orthoses includes wearing~     parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This~     study provides a new method for ankle foot orthoses design and has great significance for~     ankle rehabilitation.~   "
85160|NCT01942746|"~     Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision~     is controversial. Two clinical trials were conducted to investigate whether blueberry juice~     consumption affected visual dark adaptation, functional night vision, and recovery after~     photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout~     period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week~     intervention plus an 8 week washout and tested one blueberry juice dose against a juice~     placebo.~   "
85161|NCT01942733|"~     To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep~     disturbances.~   "
85162|NCT01942720|"~     This study is designed to evaluate the performance of VCE in the assessment of mucosal~     inflammation 6 months after the first VCE procedure~   "
85163|NCT01942707|"~     There will be performance abdominoplasty pos bariatric surgery in 32 patients. In 16~     patients will keep the Scarpa´s Fascia, and other 16 will remove the Scarpa´s Fascia.~   "
85164|NCT01942694|"~     The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D~     supplementation works to delay the onset of type 2 diabetes in people at risk for the~     disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.~   "
85165|NCT01942681|"~     This study is to evaluate the efficacy and safety that the occurrence of incontinence is~     significantly decrease using the propiverine hydrochloride for 200 female patients with~     mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment~     period.~   "
85166|NCT01942668|"~     This study will be a prospective, randomized, double-blind, placebo-controlled, parallel~     group, multicenter trial of postmenopausal subjects with an intact uterus.~   "
85167|NCT01942655|"~     Progressive HIV or HIV infection seems to be related to a preferential loss of CD4+ T~     lymphocytes, especially Th17+, within the mucosal intestinal lymphoid tissue, and with~     intestinal mucosal damage and bacterial product translocation, which correlates with the~     hyperactivation of the immune system, therefore with CD4+ T cell loss and prognosis. The~     objectives of this project are to investigate the correlation between the IL12/IL-23~     imbalance and bacterial product translocation, and to study the polarization, infection or~     depletion of intestinal Th17 ex vivo. The investigators will test the effect of neutralizing~     anti-IL23 antibodies directed against p40, or less classically, anti- IL-23 p19.~   "
85168|NCT01942642|"~     Meibomian gland dysfunction (MGD) is a common and important disease has been investigated~     the pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD~     after the cataract surgery, the most popular surgery to ophthalmologist, had not been~     evaluated. The investigators evaluated parameters related with MGD including lid margin~     abnormalities, meibomian gland expressibility and meibography before and after surgery.~   "
85169|NCT01942629|"~     The p63 gene is a recently discovered member of the p53 family located at chromosome~     3q27Many studies have reported that overexpression of p63 can mimic p53 activities by~     binding DNA, activating transcription, and inducing apoptosis.~      Various studies proved p63 as a marker of basal cells in normal salivary glands, breast,~     prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies.~     Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast~     carcinoma, and no study has described the correlation of p63 with pancreatic ductal~     adenocarcinoma.~      In the current study, we aim to evaluate the prognostic value of the expression of p63 in~     the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We~     will achieve this aim by collecting clinical data retrospectively from the patients' medical~     records as well as assessing the histological sections and performing immunohistochemical~     staining for p63.~   "
85170|NCT01942616|"~     We propose an experimental design to empirically establish the potential link between the~     media portrayal of DV and changes in an individual's DV descriptive and injunctive social~     norms. Specifically, this study will measure the degree to which people implicitly collude~     with DV perpetration.~   "
85171|NCT01942603|"~     The purpose of this registry is to collect data in order to discover whether melanoma~     patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND)~     or not.~      Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a~     CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal~     basin as the SN. However, if the positive (or metastatic) SN is only minimally involved,~     some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND~     procedure does not increase survival for patients with a minimal SN tumor burden, but can~     add prognostic information, potentially useful in the subsequent decision-making process.~     However, this is a surgical operation for the patient, which might be accompanied by~     significant side effects. Moreover, only approximately 20% of patients with a metastatic SN~     have further lymph node metastases in the same basin, which means that about 4 patients out~     of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN~     positive patients could be safely spared from a CLND. It has been demonstrated that breast~     cancer patients with minimal SN tumor burden can be safely managed with nodal observation~     only, without performing a CLND. There is evidence that the same situation exists in~     melanoma as well, but this needs to be validated and this is why we are conducting this~     registry.~      The results of this registry will be crucial to establish an accepted standard of care (CLND~     or nodal observation) for melanoma patients with minimal SN tumor burden.~   "
85172|NCT01942590|"~     Funding Source- FDA OOPD~      The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor~     function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme~     replacement therapy (ERT).~   "
85195|NCT01942291|"~     Individuals with reduced plasma concentration of high-density lipoprotein (HDL) cholesterol~     are more susceptible to oxidative stress and often present reduced endothelial function,~     which has been mainly related to this susceptibility. Studies in animal and cell models have~     demonstrated that niacin activates both GPR-109A in leukocytes and heme oxygenase-1 (HO-1)~     pathway promoting strong anti-inflammatory and anti-oxidative effects. . In this context,~     the aim of this study was to investigate the short-term effect of niacin on endothelial~     function and verify the existence of interaction of PGD2 receptor antagonist, i.e.~     laropiprant (LRPT), in subjects with low HDL-cholesterol (HDL -C).~   "
85196|NCT01942278|"~     BHOMA Interventions~      The purpose of this study is to assess the impact of the BHOMA intervention on health in 3~     rural districts of Zambia.~   "
85173|NCT01942577|"~     The skin and intestinal tracts of humans are covered with microbes, and the gene products of~     these microbes are collectively known as the human microbiome. Many studies in recent years~     have linked the microbiome to many aspects of human health and disease. Premature infants~     are vulnerable to invasive infections, some of which may originate from the microbes that~     colonize the skin and in the intestinal tract. Therefore, determining the patterns of early~     life colonization and the sources of colonization in these infants may be critical to~     determining infectious risks. This prospective study is proposed to identify the sources of~     microbes that colonize extremely low birth weight (ELBW; <1000 g birth weight) infants~     immediately following birth through the first month of life. The study team plans to~     non-invasively survey the skin and stool of ELBW preterm infants in combination with~     sampling of their mothers' skin and stool and the intensive care nursery (ICN) environment.~     As controls, the study team will perform a similar survey of full term mother-infant pairs.~     Samples will be analyzed using high throughput sequencing techniques to determine microbial~     content.~      Topical barrier sprays or emollients are commonly used early in life in the ELBW infant to~     reduce insensible water loss and enhance the integrity of the skin barrier. The effect of~     these treatments on the development of the skin microbiome remains unknown. As part of this~     study, the study team also proposes the application of two different skin barrier therapies~     to small areas on infant's legs to determine the effects of the different treatments on skin~     colonization. While all parts of the study are described in this summary and the detailed~     description, the remainder of the record focuses on this interventional portion of the study~     (Group 2).~      The goals of this study are outlined as follows:~        1. To elucidate the relationship between microbes in the health care environment and~          colonization patterns of the intestinal tracts in preterm and term infants.~        2. To understand the relationship between mode of delivery, the health care environment,~          and the colonization of the skin in preterm and term infants.~        3. To determine the effects of topical skin barrier therapies on the colonization patterns~          of the skin in preterm infants.~        4. To ascertain the relationship between the composition of the microbes colonizing~          preterm and term infants and the development of mucosal and systemic immunity to those~          microbes.~   "
85174|NCT01942564|"~     After a head injury, many people find that exposure to light causes them increased~     discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue~     light, this study will investigate whether this phenomenon is due to a change in the eye's~     sensitivity to light.~   "
85175|NCT01942551|"~     This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and~     pharmacokinetic interaction after oral concomitant administration of tadalafil and~     dutasteride in healthy male volunteers.~   "
85176|NCT01942538|"~     Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with~     fibromyalgia may maintain the clinical improvement.~   "
85177|NCT01942525|"~     Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and~     long-term neurodevelopmental outcome has been published in numerous studies. Throughout this~     analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm~     infants below 30 weeks of gestation was assessed. The second concern was the correlation~     between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome,~     comparing infants with and without IUGR.~      Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of~     gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG~     score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure~     activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of~     Infant Development and standardized neurologic examination.~   "
85178|NCT01942512|"~     Endovascular treatment is now the first line treatment for the management of intracranial~     aneurysms. However aneurysm recanalization is an important limitation to this treatment.~     Several factors seems to be associated with aneurysm recanalization including medical~     history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and~     location, modalities of treatment, immediate post-operative occlusion of the aneurysm.~      A precise knowledge of factors increasing the risk of aneurysm recanalization is quite~     important to optimize strategy of treatment and reduce the recanalization rate. No large,~     prospective, multicenter trial dealing with this question has been published in the~     literature.~   "
85179|NCT01942499|"~     It is well established that individuals living with chronic obstructive pulmonary disease~     (COPD) demonstrate significant improvements following a formal rehabilitation program. The~     problem lies in the fact that these functional improvements diminish over a 12 month period.~     This decline in function is associated with decreased participation, a decline in health~     status, and an increased need to access the healthcare system. The objective of this project~     is to evaluate the effectiveness of a post-rehabilitation community-based exercise program~     for individuals with COPD and compare the outcomes with those achieved through standard~     care.~      Individuals with COPD who have completed a previous rehabilitation program will be enrolled~     in the study. Study participants will be assigned randomly to either a year-long community~     exercise program or usual care. Those assigned to the community program will exercise twice~     weekly at a local community centre supervised by trained fitness instructors. A case manager~     will facilitate the transition from the hospital rehabilitation program to the community~     centre. The case manager will also be available to participants and instructors for consult~     as needed. Continuing to build on an established partnership with the City of Toronto, the~     case manager will ensure fitness instructors receive specialized training in order to~     properly supervise and support the individuals with COPD. Participants assigned to usual~     care group will receive standard care by their family physician and respiratory specialist.~     Functional status will be evaluated before the program begins and again at 6-months and~     1-year. The outcome of each group will be compared to determine the effectiveness of the~     community exercise program. It is hypothesized that individuals who participate in the~     community exercise program will have better function and quality of life versus those~     individuals who receive standard care.~   "
85180|NCT01942486|"~     The purpose of this study is to determine if a special coating, applied to the surface of~     glasses can reduce the frequency and severity of migraine headaches in children and~     adolescents. This study is being conducted by researchers at Primary Children's Medical~     Center, The John Moran Eye Center, and the University of Utah Department of Electrical~     Engineering. The investigators have determined that a specific frequency of light is~     particularly bothersome to migraine patients. The coating they've developed is designed to~     block this frequency of light. Very few treatments are approved for the treatment of~     childhood migraine. The investigators hope that these glasses will provide a safe way to~     improve headaches in children.~   "
85181|NCT01942473|"~     In this study the investigators test the hypothesis that automated FiO2 adjustment increases~     the time of brain tissue oxygenation within the intended reference range. Furthermore, the~     investigators studied the change in workload during automated FiO2 adjustment as compared to~     manual adjustment by the nursing staff.~   "
85182|NCT01942460|"~     The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of~     iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney~     disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact~     of the administration of a ferumoxytol dose on various markers for iron stores, as well as~     on various markers for inflammation and oxidative stress.~   "
85197|NCT01942265|"~     This Phase II randomized, double-blinded, controlled study in up to 1000 males and~     non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all~     eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen~     derived from the influenza A/Shanghai/2/2013 virus.~   "
85198|NCT01942252|"~     The purpose of this study was to determine whether high carboxyhemoglobin level is a risk~     factor for postoperative adverse events in children exposured to carbon monoxide, especially~     enviromental tobacco smoke.~   "
85183|NCT01942447|"~     The host gastrointestinal microbiota is significantly influenced by antibiotic treatment~     which might favor Clostridium difficile infection (CDI), a frequent cause of community- and~     hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in~     19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no~     standardized therapy of recurrent or refractory CDI, but recent studies show remarkable~     effects of fecal microbiota transplantation (FMT).~      In the current project, we aim to ideally match host and donor for FMT success in recurrent~     or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will~     evaluate its safety and efficacy, and the patient acceptance and quality of life before and~     after FMT. We will analyse persistence of the donor microbiota within the recipient, define~     predictive clinical recipient and donor factors for FMT success and correlate them with~     microbial host and donor metagenomics.~      We hypothesize that our work will yield novel, individualized strategies for recurrent or~     refractory CDI. In perspective, our results may be expanded to treatment of other inflammory~     bowel diseases.~   "
85184|NCT01942434|"~     Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of~     breastfed infants.~      Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast~     milk sample.~      Phase 2: At 6 months of age child participates in electrophysiology session to test~     recognition memory.~      Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical~     assessments.~   "
85185|NCT01942421|"~     The purpose of this study is to elucidate the appropriate condition of developing cultivated~     autologous oral mucosal epithelial graft and evaluate the surgical outcome of~     transplantation of the cultivated cells in the patients.~   "
85186|NCT01942408|"~     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and~     causes an irregular and often rapid heartbeat. Developing this condition may cause~     significant health problems and symptoms that affect normal day-to-day activities. Patients~     with AF also have a shorter life expectancy on average. Tablets used to try to normalise the~     heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure~     this condition. Special wires (called catheters) are used to deliver heat energy (called~     ablation) on the inside surface of the heart. This technique has been used more and more in~     recent years for patients with troublesome symptoms due to AF.~      The aim of the treatment is to draw lines of ablation in specific places in the heart.~     Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of~     these patients have a second treatment performed. It is usually found at this second~     treatment that gaps have developed in the lines of ablation that were drawn the first time~     around. The investigators think that electively doing a second treatment to close these gaps~     a couple of months after the first treatment may mean that fewer of these patients will get~     AF again in the future. The investigators also want to find out what factors make a line of~     ablation less likely to develop gaps.~      In this study, participants will be assigned to one of two groups:~        1. a standard care group, who will have a single treatment initially.~        2. a repeat study group, who will have the initial treatment followed by a second~          treatment 8-10 weeks later.~      For patients in the repeat study group, investigators will see how many have developed~     gaps since their first treatment. The investigators will look at where these gaps are and~     will compare this with information collected during the first treatment to try to work out~     why the gap has developed. Any gaps found at the second treatment will be closed again.~      All participants will then be monitored carefully over 12 months to see how many from each~     group get AF again. To do this, all participants will be given a handheld heart rhythm~     monitor to keep until the end of the study. This device is simple to use. Participants will~     be asked to make a 30 second recording of their heart rhythm each day and also whenever they~     have symptoms. These recordings will be downloaded at review appointments arranged 6 weeks,~     3 months, 6 months and 12 months after the initial ablation procedure.~   "
85187|NCT01942395|"~     The purpose of this study is to examine how dietary changes affect the heart and blood~     vessels in patients with hypertension (high blod pressure) who have a condition called~     'heart failure with preserved ejection fraction (HFPEF). This condition is also known as~     diastolic heart failure or heart failure with normal ejection fraction, and occurs even~     though the heart's pumping function is normal.~   "
85188|NCT01942382|"~     The purpose of this study is to evaluate the pharmacokinetics (study of what the body does~     to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents~     in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder)~     or gluteal muscle (group of muscles present in the buttocks) in participants with~     schizophrenia.~   "
85189|NCT01942369|"~     The purpose of this study is to describe changes in the intensity of specific endometriosis~     symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline~     (Triptorelin Acetate) treatment for up to 24 weeks.~   "
85190|NCT01942356|"~     The purpose of this study is to compare a closed-loop intravenous anesthetic using~     Bispectral Index as a feedback loop and a controller based on reinforcement learning to~     titrate dose and intravenous anesthetic that is manually controlled or a standard volatile~     anesthetic agent titrated by the anesthesiologist to determine improvement in the following~     parameters as compared to controls: time to discharge from the Post Anesthesia Care Unit,~     post-operative nausea and vomiting, pain scores and sedation scores.~   "
85191|NCT01942343|"~     The main objective of this study is to evaluate the incidence of akathisia with Droperidol,~     the prophylactic treatment of post operative nausea and vomiting, used at two different~     doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to~     compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg~     and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is~     that there is a greater risk of akathisia among patients taking Droperidol in prevention of~     NPVO, that among patients taking Ondansetron.~   "
85192|NCT01942330|"~     This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for~     colonic resection in adult women that eliminates the need for an abdominal incision to~     remove surgical specimens. It is hypothesized that this LANOS technique will improve patient~     outcomes such as postoperative surgical site infection (SSI) rates, thereby improving~     patient satisfaction and also reducing hospital length-of-stay and cost.~   "
85193|NCT01942317|"~     The aim of the study is to evaluate the role of balneotherapy in obese patients with knee~     osteoarthritis in terms of pain relief, improving joint function and deambulation, on~     endocrinological parameters, quality of life and of reduction the costs to Servizio~     Sanitario Nazionale (NHS).~   "
85194|NCT01942304|"~     The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and~     histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS~     putty bone substitute in posterior maxillary sites and the survival of implants placed in~     these sites following healing.~   "
85212|NCT01942070|"~     The aim of the current study is to test the clinical performance of the everolimus-eluting~     BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients~     undergoing PCI in the setting of acute MI.~   "
85199|NCT01942239|"~     Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their~     neurological outcome. The aim of this study was to compare real-time continuous glucose~     monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose~     testing in detecting and managing hypoglycemia. The investigators calculated a number of 48~     neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days~     of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing~     (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The~     investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will~     be lower.~   "
85200|NCT01942226|"~     Dry eye is a common complaint in patients encountered by ophthalmologists, which may result~     from the inflammatory response and can occur in the absence of systemic disease. However,~     the management of dry eye syndrome in real setting warrants assessment but remains lacking~     in Taiwan. We conducted an perspective observational study to evaluate the medical~     management of dry eye patients.~   "
85201|NCT01942213|"~     This open-label, Phase IV prospective, observational study will evaluate patients, who have~     been diagnosed with Neovascular Age-Related Macular Degeneration and have previously~     received either a standard intravitreal injection of ranibizumab or aflibercept, in order to~     get and compare information regarding post-injection inflammatory (irritation in the eye)2-3~     days post-injection.~      Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.~   "
85202|NCT01942200|"~     The main purpose of this observational study with Oxaliplatin onkovis is to determine the~     number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose~     under the special circumstances of ambulant chemotherapy.~      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This~     includes provision of appropriate packaging sizes to decrease the excess quantity to be~     discarded, and thus also follows this objective.~      Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this~     end, data regarding co-medication and adverse events are also collected.~   "
85203|NCT01942187|"~     The purpose of this study is to compare the effectiveness of two different augmentation~     strategies of antidepressant treatment for depressed older adults who have not responded to~     an adequate trial of antidepressant medication. The first augmentation strategy is Problem~     Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective~     in depressed older adults. The second augmentation strategy is medication augmentation,~     which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that~     has also been shown to be effective in depressed older adults who have failed a trial of~     antidepressant medication.~   "
85204|NCT01942174|"~     To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by~     the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and~     who begin a treatement by methotrexate either in the same time, either 1 month later.~   "
85205|NCT01942161|"~     The objective of this study is to investigate the efficacy and safety of three different~     doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a~     period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia~   "
85206|NCT01942148|"~     The objective of this study is to investigate the safety and efficacy of aripiprazole~     (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally~     administered over a period of 52 weeks in subjects who complete a short-term treatment study~     of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).~   "
85207|NCT01942135|"~     The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the~     primary objective of demonstrating the superiority of palbociclib in combination with~     fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2~     negative metastatic breast cancer whose disease has progressed after prior endocrine~     therapy. The safety between the two treatment arms will also be compared. During study~     treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist~     goserelin (Zoladex® or generic).~   "
85208|NCT01942122|"~     This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for~     the treatment of pain in patients suspected endometriosis. It is hypothesized that the~     reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of~     study (week 8th) resulting from administration of DLBS1442, regardless of the dosage~     regimen, is significantly greater than that of Control. In addition, the administration of~     DLBS1442 at higher dose also results in significantly greater reduction than that of~     DLBS1442 at lower dose and of Control.~   "
85209|NCT01942109|"~     The aim of the study is to compare the effects of torasemide and furosemide on clinical and~     biochemical parameters of hemodynamic and neurohormonal compensation and myocardial~     remodeling in patients with chronic heart failure with indications for use of loop~     diuretics.~      The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV~     (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose~     loop diuretics]) treated with optimal medical therapy as clinically indicated for use loop~     diuretics. Patients will be randomized to treatment with furosemide and torasemide~     (randomization 1 : 1). After randomization, furosemide will continue in its current~     fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal~     follow-up of patients in the study will be at least six months.~   "
85210|NCT01942096|"~     High school elite training programs are today more and more under development in several~     'elite sport schools' in Belgium, in order to select and train future elite athletes already~     at young age. Little is known about the effects of sustained training on the potential~     development of asthma in adolescents during lung growth. It would be of great importance to~     be able to select the individuals at risk to develop exercise-induced asthma, already at the~     start of their enrollment in the 'elite sport school. This would allow physicians to follow~     their lung function parameters very closely and regularly; and, if necessary, start~     treatment early after the first signs of exercise-induced asthma.~   "
85211|NCT01942083|"~     This is a Phase I, open label, non randomized, multicenter study designed to investigate the~     safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in~     subjects with advanced HCC.~   "
85213|NCT01942057|"~     The goal of this study is to determine the prevalence of nearsightedness in Canadian school~     children living in the Waterloo Region.~   "
85215|NCT01942031|"~     Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all~     patients relapse. Secondary prevention is proven efficient but observational studies have~     shown that a number of patients are lost to follow up and do not receive recommended~     prevention. The aim of the study is to 1) describe, by analyzing register data, the~     detection rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation~     in the primary care center where they are listed. The analysis is done by sex, age, and~     socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive~     drugs are analysed for the identified population. 2) in a randomized controlled study~     evaluate if collegial feed back and targeted information of secondary prevention to the~     intervention group can improve the detection rate and the medication of the patients listed~     at the participating primary care centers.~   "
85216|NCT01942018|"~     This research is being done to study an endoscopic procedure called POEM as a less~     invasive alternative to surgery in people with esophagogastric junction outlet obstruction~     (EGOO).~   "
85217|NCT01942005|"~     Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.~   "
85218|NCT01941992|"~     The purpose of this study is to:~        -  evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in~          head-and-neck cancer patients undergoing chemo-radiotherapy.~        -  assess tolerability of SAMITAL and the impact on patients reported outcomes.~   "
85219|NCT01941979|"~     Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed~     early, however local recurrence risk increases when the disease is diagnosed at advanced~     stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35%~     and positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data~     indicate that patient who have a high risk of tumor recurrence should receive an adjuvant~     therapy treatment.~      It is possible that adjuvant chemotherapy has a positive impact on survival of patients~     already treated with neoadjuvant combination therapy. However it is necessary to identify~     those patients that might have this benefit.~      An exploratory analysis of the European Organization for Research and Treatment of Cancer~     (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the~     group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no~     reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response~     to neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant~     chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer~     remains controversial. Therefore, a randomized trial is needed to answer this question.~      Based on these data the investigators proposed a phase III study, randomized, unblinded,~     adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in~     patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant~     chemoradiotherapy and who did not presented complete response. The investigator believes~     that this subgroup of patients, who have not achieved complete response, will be benefit~     from adjuvant therapy.~      Study objective:~      The main objective of this study is verify if adjuvant chemotherapy with 5-FU and~     oxaliplatin, for 4 months, increases recurrence-free survival versus the observation.~     Secondary objectives include the evaluation of toxicity, overall survival and assessment of~     biomarkers (study protocol separately).~      The study's primary endpoint is disease-free survival (DFS) to be defined as time from~     randomization to radiological detection of distant disease and / or locoregional recurrence.~     Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a~     new measurable lesion be found.~      NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T),~     the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or~     secondary tumors formed by the spread of cancer cells to other parts of the body.~   "
85220|NCT01941966|"~     The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which~     corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been~     growing recently. The standard treatment of anal cancer stage II-III is multimodal and~     consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and~     radiotherapy. This scheme currently used was proposed in 1974, and since then no other~     effective treatment has been developed.~      The purpose of this study is to determine the efficacy and toxicity of the combination of~     capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal.~     For this will be selected 51 patients to be treated with chemo-radiotherapy.~      The primary endpoint will be local control rate after 6 months of the end of radiotherapy~     and chemotherapy, defined by the rate of radiological and clinical neoplasia.~   "
85221|NCT01941953|"~     This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in~     patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and~     Irinotecan based chemotherapy.~   "
85222|NCT01941940|"~     This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab~     (RoActemra), administered as monotherapy or in combination with methotrexate and/or other~     DMARDs, in participants with moderate to severe active RA.~   "
85223|NCT01941927|"~     This is a multicenter phase II clinical study of trametinib in combination with GSK2141795~     in patients with BRAF wild-type mutation melanoma. All patients will receive continuous~     dosing of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until~     progression of disease, withdrawal of consent, or the development of intolerable treatment~     associated toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of~     Odd Cycles, starting with Cycle 3.~      Patients may continue treatment with trametinib in combination with GSK2141795 on trial~     until disease progression or the development of unacceptable toxicity that does not improve~     with maximal supportive care or dose reduction per protocol.~      Treatment-associated adverse events will be assessed based on clinical and laboratory~     findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event~     assessments will be performed every week through cycle 3 day 1, and on day 1 for every cycle~     thereafter. AEs and SAEs will be monitored by UCSF's Data Safety Monitoring Committee.~      Safety assessments will include medical history, physical examination, CBC with~     differential, chemistries panel, thyroid function and pregnancy tests, ECGs, and~     ophthalmology evaluations. Screening assessments will also include a transthoracic~     echocardiogram or MUGA scan, and brain imaging.~      It is estimated that 48 patients will complete the study.~   "
85224|NCT01941914|"~     The purpose of this study is to evaluate the effect of calcium electroporation on keloids.~   "
85225|NCT01941901|"~     The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous~     metastases, and compare calcium electroporation with standard treatment:~     electrochemotherapy.~   "
85226|NCT01941888|"~     Many studies address safety and effectiveness of non-anesthesiologist propofol sedation~     (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for~     providing optimal sedation regimen and avoiding under or oversedation.~      This randomized double blind controlled study compares standard moderate sedation level of~     sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS~     (group P).~   "
85344|NCT01940341|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive~     and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic~     hepatitis B virus (HBV) infection.~   "
85227|NCT01941875|"~     This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with~     Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.~      Infertility is a common problem, and a popular method of therapy is to inject sperm through~     the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI,~     injectable medications (gonadotropins) are used to stimulate the ovaries to produce more~     than one egg per cycle in a process called COH.~      Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has~     been proven to effect pregnancy rates. However, the role of progesterone in COH is still~     unclear. In this study, the investigators want to examine the effect of giving vaginal~     progesterone after COH with IUI on pregnancy rates. The investigators want to study if~     luteal vaginal progesterone results in a higher pregnancy rate compared to no progesterone~     therapy in COH with IUI. At present, fertility centres vary in the use of progesterone after~     insemination, most likely due to the lack of studies on this subject.~      At the Fertility Clinic all patients undergoing COH with injectable medications and IUI,~     regardless of whether they are in the study, have a baseline transvaginal ultrasound and~     blood tests. Patients start the injectable medications for COH until the ovarian follicles~     are large enough, then a medication to release the eggs is given. The IUI is done~     approximately 36 hours later. The day after the IUI, study patients will be given vaginal~     progesterone while the control patients will receive no progesterone. All patients will be~     followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.~   "
85228|NCT01941862|"~     The purpose of this study is to test the effectiveness and usability of multiple~     computer-based treatments for mood and anxiety relevant risk factors. The target of the~     treatment is related to cognitive stress, which has been shown to be associated with a~     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal~     ideation, and substance use disorders.~   "
85229|NCT01941849|"~     The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in~     combination with standard radiation therapy, 131I-mIBG, in patients with advanced~     phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of~     the combination treatment.~   "
85230|NCT01941836|"~     The purpose of this research study is to see how ETC-1002 is tolerated in the body, to~     measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level~     of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and~     urine in patients with elevated LDL-cholesterol with or without statin intolerance.~   "
85231|NCT01941823|"~     Carnitine is essential for the transport of fatty acids into the mitochondria and energy~     production in different muscles, including the myocardium. It is also needed to protect~     myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups.~     Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk~     for carnitine deficiency as a result of its removal during the dialysis procedure, lack of~     endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of~     children undergoing continuous renal replacement therapy (CRRT) has not been studied.~     Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk~     for carnitine deficiency due to its continuous removal, lack of carnitine production by the~     kidney, and absence of carnitine intake (as majority of these children can not eat and there~     is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase~     the risk of cardiac dysfunction in critically ill children. This is the first study to~     examine carnitine status in children undergoing CRRT. Standard echo as well as more~     sensitive speckle tracking echo will be used to evaluate the effect of carnitine deficiency~     on myocardial function.~   "
85232|NCT01941810|"~     This pilot phase II trial studies how well bovine lactoferrin supplement works in improving~     taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help~     improve the ability to taste food in patients who are receiving chemotherapy.~   "
85233|NCT01941797|"~     This is a pilot study. The investigators hypothesize that the peri-implant soft tissue~     response to de novo plaque accumulation is similar to that of normal gingival tissue in the~     same subjects.~      The investigators propose to conduct a controlled clinical trial to evaluate peri-implant~     soft tissue response to de novo plaque accumulation in comparison to the response of~     gingival tissue in the same subjects~   "
85234|NCT01941784|"~     This pilot clinical trial studies a health education intervention in reducing weight gain in~     patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health~     education program may reduce weight gain and improve quality of life in patients undergoing~     chemotherapy for breast cancer.~   "
85235|NCT01941771|"~     The study hypothesis is that metronomic treatment is more efficient than standard treatment.~   "
85236|NCT01941758|"~     This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune~     response patients with central nervous system tumors. Studying samples of blood in the~     laboratory from patients receiving trivalent influenza vaccine may help doctors learn more~     about the effects of trivalent influenza vaccine on cells. It may also help doctors~     understand how well patients respond to treatment.~   "
85249|NCT01941589|"~     The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and~     recommended by professional societies. However, there are no data investigating whether the~     addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic~     corticosteroids is superior to corticosteroids alone in patients with moderate-severe active~     UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue),~     on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to~     compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the~     treatment of moderate-severe UC exacerbation.~   "
85250|NCT01941576|"~     The purpose of this study is to determine the effects of rhRNP on urine output and~     hemodynamics following corrective repair of Tetralogy Of Fallot.~   "
85251|NCT01941563|"~     The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in~     patients with lumbar disc herniation.~   "
85252|NCT01941550|"~     This study is aimed at evaluating the efficacy regarding the response rate and~     metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with~     high risk prostate cancer.~   "
85358|NCT01940146|"~     The study will assess the efficacy and safety of SPARC1310 when compared to placebo and~     active control~   "
85237|NCT01941745|"~     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result~     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical~     ventilation and infection. These conditions initiate an inflammatory response characterized~     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the~     development of significant acute and chronic lung injury.~      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10~     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and~     is the most abundant protein in the mucosal fluids in normal healthy lungs.~      The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and~     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated~     premature infants receiving positive pressure ventilation for treatment of respiratory~     distress syndrome (RDS) to prevent long term respiratory complications referred to as~     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;~     asthma, cough, wheezing, multiple respiratory infections).~      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary~     tissue while preserving pulmonary mechanical function during various insults (eg. viral~     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties~     suggest that administration of rhCC10 may help to facilitate development of normal airway~     epithelia and prevent the inflammation that leads to CRM in these infants.~      This study is funded by the FDA Office of Orphan Product Development (OOPD).~   "
85238|NCT01941732|"~     Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile~     dysfunction. A number of patients have reported that when they take Sildenafil, their need~     of anti-PD medication is reduced.~      We hypotheses that sildenafil increases brain blood flow and hence improves the function of~     specific brain regions, improving motor function.~      Motor function and cerebral blood flow of 8 patients will be tested before and after~     Sildenafil intake and before and after anti-PD medication.~   "
85239|NCT01941719|"~     The purpose of this study is to examine the effectiveness of a novel patient education~     strategy, compared to a standard diabetic foot education. The proposed diabetic foot care~     education uses personal computer-animated plantar pressure data to educate patients on why~     and how they should care for their feet.~   "
85240|NCT01941706|"~     Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed~     to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials~     were demonstrated to be effective in treating depression among people with epilepsy in~     Georgia. This project will assess whether the materials are also effective for preventing~     depression among people with epilepsy, and will extend the project beyond Georgia to~     Michigan, Texas, and Washington.~   "
85241|NCT01941693|"~     There is a high rate of psychological comorbidity in people suffering from alcohol~     dependence. There is a need for an effective integrated treatment for alcohol dependence and~     comorbid anxiety or depression. This study will test the efficacy of a novel integrated~     intervention for comorbid alcohol dependence and anxiety or mood disorder.~   "
85242|NCT01941680|"~     Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and~     Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger~     than 65 years old, an allogeneic donor is searching out. Patients included at relapse and~     with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are~     assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response~     criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old~   "
85243|NCT01941667|"~     The investigators want to determine if additional, increased contact with infants and~     families discharged to home after cardiac surgery improves infant and parent outcomes as~     compared to usual care.~   "
85244|NCT01941654|"~     To determine the efficacy of preemptive local ablative therapy in NSCLC patients with~     activating EGFR mutation who have oligometastatic residual metabolic-active disease after~     first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.~   "
85245|NCT01941641|"~     Objective tumour response rate to FOLFOXIRI to pre-operative therapy.~   "
85246|NCT01941628|"~     Cesarean delivery under general anesthesia is one of few only surgical procedures, where the~     most important factor of safety is the speed of the surgery, as a newborn adaptation~     strongly depends on a time between induction to the general anesthesia (and administration~     of anesthetics) and pennywort ligation. The shortest possible interval is essential for the~     amount of anesthetics crossing placenta into the fetal circulation.~      The primary objective:~      To compare surgical conditions for fetus delivery in Cesarean section under general~     anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine.~      The primary safety objective:~      To compare influence of different levels of neuromuscular blockade and surgical conditions~     on newborn adaptation after the Cesarean delivery.~      The secondary objectives:~      To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean~     section on surgical conditions for suture of the uterus and the abdominal wall with~     attention to blood loss, time of surgery and surgical complications.~      To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by~     rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of~     procedure.~      Clinical hypotheses:~      The use of deep muscle blockade in Cesarean section under general anesthesia, including the~     period of fetus delivery, compare to the standard recommended practice with succinylcholine,~     will improve the surgical conditions and allow faster and easier delivery of the fetus with~     positive effect on its postnatal adaptation. Faster delivery will reduce an incision to~     delivery interval with decrease of time between anesthetics administration and delivery.~     This will reduce the amount of anesthetics crossing the placenta to the fetal circulation.~     Both, reduced amount of anesthetics and reduced incision to delivery interval itself will~     improve a newborn adaptation after Cesarean delivery.~      Deep neuromuscular blockade will also improve surgical conditions for the whole surgery,~     when no or shallow only neuromuscular blockade is routinely used. We assume that deep~     neuromuscular blockade during the entire surgery will create better surgical conditions for~     faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood~     loss and incidence of surgical complications.~   "
85247|NCT01941615|"~     Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the~     multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in~     healthy premenopausal female volunteers.~   "
85248|NCT01941602|"~     The aim of the study is to compare different strategies for prevention of venous~     thromboembolism related to intracranial meningioma surgery. The investigators identified~     three hospitals where two have a very restrictive approach with respect to anticoagulant~     therapy while at the third hospital the use of anticoagulation the day before surgery was~     initiated as routine prophylaxis.~      Based on this natural experiment it will be explored whether the use of anticoagulant~     prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with~     increased risk of postoperative hemorrhage as compared to the 2 cohorts where this~     intervention were absent.~   "
85281|NCT01941173|"~     This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with~     metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop~     the growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a~     shorter infusion time may result in improved efficiency and patient satisfaction.~   "
85253|NCT01941537|"~     Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most~     aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of~     adults and up to 25% among children. AD has a complex pathogenesis, characterized by: 1)~     immune activation with increased numbers of T-cells, dendritic cells (DCs), and increased~     expression of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased~     skin, and 3) defective barrier function with increased trans-epidermal water loss (TEWL) and~     decreased lipids, reflecting underlying alterations in keratinocyte differentiation. AD is~     predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a~     T22 (IL-22) polarized disease.~      ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD.~     This study is being done to assess the safety, tolerability, clinical efficacy, and~     mechanism of action of ILV-094 in patients with AD.~   "
85254|NCT01941524|"~     The purpose of the study is to determine whether there are differences in bioelectrical~     function (measured by amplitude integrated electroencephalography) and brain oxygenation~     (measured by near infrared spectroscopy) while and after instillation of two different~     surfactant preparations.~   "
85255|NCT01941511|"~     This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of~     GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug~     development.~   "
85256|NCT01941498|"~     The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery~     using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).~   "
85257|NCT01941485|"~     The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond~     laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT)~     anterior segment corneal measurements compared to pre-operative flap thickness target.~   "
85258|NCT01941472|"~     Fluid challenge is often carried out in critical ill patients. Its responsiveness usually~     requires invasive monitoring. To use non-invasive methods is very tempting. We hypothesize~     that transcutaneous pO2,transcutaneous pCO2 and Central Venous pO2 variations provide~     feasible estimation on fluid responsiveness in critical ill patients.~   "
85259|NCT01941459|"~     Thru the last 20 years it has been a discussion witch solution that gives the best~     myocardial protection during cardiac arrest by heart operations.~        -  It has been a tendency that a blood based cardioplegia gives a better protection bye~          long ischemic times but it has not been possible too conclude in this matter.~        -  The investigators have two groups of cardioplegia, the blood based and, the crystalloid~          based cardioplegia.~        -  It has been done a lot of studies to see what kind of cardioplegia that gives the best~          myocardial protection. Different temperature, different amount and content, retrograde~          or antegrade or both, contentiously and further on have been tested without a clear~          conclusion.~        -  The investigators decided to make a study with a cohort of patients as homogenous as~          possible with a cross clamp time around 70 min.~        -  Adult patients' with a severe aortic stenoses without any other significant heart~          disease was included in our prospective randomised study.~        -  Patients with additional significant coronary artery disease (≥ 50% stenoses) were~          excluded from the study.~        -  The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the~          myocardial damage.~   "
85260|NCT01941446|"~     This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way~     crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through~     3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4~     nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be~     a minimum of a 14 day washout between treatments.~   "
85261|NCT01941433|"~     The purpose of this study is to determine whether an online patient passport tool called the~     Arthritis Health Journal can assist people with rheumatoid arthritis in managing their~     disease.~   "
85262|NCT01941420|"~     The investigators decided to make a study with a cohort of patients as homogenous as~     possible with a cross clamp time around 70 min. Adult patients with a severe aortic stenoses~     without any other significant heart disease was included in our prospective randomised~     study. This group of patients was chosen for two reasons. First, these patients have left~     ventricular hypertrophy making the myocardium vulnerable to ischemia, secondly the~     investigators wanted to avoid the possible confounding effect of ischemia found in patients~     with variable degrees of coronary artery disease. Therefore, patients with additional~     significant coronary artery disease (≥ 50% stenoses) were excluded from the study.~   "
85263|NCT01941407|"~     The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase~     III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra~     toxicities.~      It could be interesting to explore the combination of bev + eribulin in first line~     metastatic breast cancer.~   "
85264|NCT01941394|"~     Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant~     (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis~     and treatment.~   "
85265|NCT01941381|"~     Due to recent efforts to decrease antibiotic overuse, and reports of high rates of~     spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now~     wait 48-72 hours before starting antibiotics for common ear infections. The investigators~     are interested to see if those patients with documented middle ear effusions, as determined~     by tympanometry, have higher rates of eventual antibiotic usage than those with normal~     tympanometry results. If there is a significant disparity between those with a positive~     tympanogram and those without the investigators may be able to identify a group that will~     benefit from antibiotics and a group that would not need treatment.~   "
85282|NCT01941160|"~     The objectives of this study are to evaluate stool consistency and stool frequency during~     and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid~     875mg BID.~   "
85300|NCT01940926|"~     This is an open-label positron emission tomography/computed tomography ( PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in~     rheumatoid arthritis (RA) patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤ 40~     µg BNOTA-PRGD2) will be intravenously injected into patients with RA. Visual and~     semiquantitative method will be used to assess the PET/CT images. Whole body 18F-FDG PET/CT~     will be performed for comparison.~   "
85266|NCT01941368|"~     Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT)~     and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold,~     critical power, anaerobic working capacity and neuromuscular economy in a population of~     endurance trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on~     changes in skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length)~     and muscle quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.~      Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to~     participate in this study. Subject will be randomized to one of three groups: a control~     group (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite~     HMB and perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing.~     They will then be asked to continue their normal exercise routine for 4 weeks and will~     undergo post-testing after this time period.~      Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours~     prior to the start of the training period. The same testing protocols will be repeated at~     the end of the 4-week training period. Testing protocols include performance testing~     (VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular~     economy) and anthropometric measures (physiological cross-sectional area and muscle~     quality). The training protocol for individuals in the experimental groups will consist of~     4-weeks of high intensity interval training with three sessions per week on an~     electronically braked cycle ergometer. Individual work -loads will be calculated based on~     the outcomes from each participant's preliminary testing.~   "
85267|NCT01941355|"~     Patients undergoing coronary artery bypass graft surgery often experience a range of~     problems and symptoms related to the procedure and the underlying heart disease. These~     problems include anxiety and depressive symptoms, immobility issues, complications such as~     wound seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2~     decades, cardiac rehabilitation has become recognized as a significant component in the~     continuum of care for persons with cardiovascular disease. Furthermore, cardiac~     rehabilitation has undergone a significant evolution moving from a focused exercise~     intervention to a comprehensive disease management program. In Guidelines for Coronary~     Artery Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation~     during hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks~     following surgery. Our hypothesis is that physical exercise with moderate intensity and a~     psycho-educative component as a part of cardiac rehabilitation can begin in early~     postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in~     coronary artery bypass graft surgery patients are promising. However, no randomised trials~     have been conducted, and evidence is therefore lacking.~      The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive~     cardiac rehabilitation programme consisting of a psycho-educative component, an~     exercise-training component including pulmonary training, cycling, neck and shoulder~     exercises, these in combination plus treatment as usual and treatment as usual in patients~     who undergo coronary artery bypass grafting.~      SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial~     with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central~     randomisation to phase 1 rehabilitation; 1) exercise-training plus usual care, 2)~     psycho-educative plus usual care 3) exercise-training and psycho-educative plus usual, 4)~     usual care alone.~   "
85268|NCT01941342|"~     The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD)~     which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by~     observing the prevalence of drainage and surgery related complications, hospital stay,~     medical cost and life quality compared to surgery alone. It is anticipated that PBD can~     reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.~   "
85269|NCT01941329|"~     This study is a prospective, randomized, multicentre, open label study that intents to~     compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus~     Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of~     the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy~     over a 12-month treatment period.~      One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of~     the leading causes of visual impairment in working age in industrialized countries. Longer~     diabetes duration and poor glycaemic and blood pressure control are strongly associated with~     Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4%~     and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately~     93 million people have Diabetic Retinopathy and 17 million of them have Proliferative~     Diabetic Retinopathy.~      It has been shown that treatment with repeated injections of ranibizumab can improve visual~     acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains~     unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete~     and, therefore, efforts should be done to understand and characterize patients' eyes~     response to combined treatments.~      Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e.~     Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV~     injections of ranibizumab since it is expected that anti-vascular endothelial growth factor~     (VEGF) treatment with ITV injections will increase the rate of success of Panretinal~     Photocoagulation in regression of neovascularization with improved final visual acuity.~   "
85270|NCT01941316|"~     The purpose of this study is to determine a well-tolerated dose of Carfilzomib in~     combination with Irinotecan in subjects with relapsed small and non-small cell lung cancer~     or other irinotecan-sensitive cancers and to assess the 6 month survival of relapsed small~     cell lung cancer patients treated with this combination therapy.~   "
85271|NCT01941303|"~     As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent~     non-small cell lung cancer. Even after primary radical treatment to high doses,~     re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again~     using high doses of radiation.~      Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and~     toxicity for patients treated in MAASTRO are unknown at present. This study will provide~     knowledge on benefit and risks of such a therapeutic approach.~   "
85283|NCT01941147|"~     There is great interest in the development of novel therapies for acute ischemic stroke~     because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests~     that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for~     acute ischemic stroke therapy because of their effects on the main mechanisms of brain~     ischemic damage and regeneration.The main purpose of this open label, one arm, dose~     escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective~     tool to promote recovery in acute ischemic stroke patients Nine patients will be treated~     daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose~     cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at~     increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be~     evaluated by the incidence of adverse events and mortality throughout the stimulation period~     and the 1-year follow-up. Secondary outcomes will consist in change from baseline in~     clinical and radiological scores.~   "
85272|NCT01941290|"~     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to~     long-term complications range from rather immediate elastic recoil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from~     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents~     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug~     Eluting Stents (DES) significantly improved on the principle of BMS by adding an~     antiproliferative drug (directly immobilized on the stent surface or released from a polymer~     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the~     incidence of restenosis and resulted in a better safety profile as compared to BMS with~     systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      An interesting group of analysis resulted to be diabetic patients. It has been concluded~     that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic~     subjects after stenting as judged from comparison with historical control subjects. Results~     implicate accelerated restenosis as both a consequence of diabetes and a cause for increased~     mortality after PCI in diabetic patient.~      Therefore this observational registry has been designed for the clinical evaluation of the~     Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary~     revascularization with Drug Eluting Stents (DES). Results will contribute to the collection~     of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in daily clinical practice.~   "
85273|NCT01941277|"~     The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR)~     in subjects who do not routinely exercise and who are at risk of developing diabetes~     (prediabetes).~      It is estimated that approximately 30-90 people will participate in this study at three~     study sites in the United States and United Kingdom.~   "
85274|NCT01941264|"~     Malaria is a common disease in Africa and a major health problem. Pregnant women are also at~     risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby~     she is carrying. It can result in the destruction of the mother's blood and in babies with a~     lower birth weight than normal, making them less healthy in their first years of life. These~     risks are even higher in women having their first pregnancy.~      When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the~     ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against~     malaria. This drug helps protect the woman against getting malaria. Each pregnant woman~     should receive at least 2 doses of this drug during their pregnancy; thus, they should go~     the ANC at least 2 times during their pregnancy. However, many women still do not go often~     to the ANC for health care during their pregnancy.~      This study would like to see whether community health workers (CHW) can work with pregnant~     women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman~     every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in~     her home instead of the woman having to go a health clinic for treatment. The woman will be~     treated with a different drug than the drug that is given at the ANC visits. Our hypothesis~     is that this will improve the care and management of malaria during pregnancy and this will~     improve the health of women and their newborns. To see whether this strategy improved the~     health of women and their newborns, we will take a small piece of the placenta at delivery~     to test for malaria and we will weigh the baby. We will test this strategy in multiple~     communities. We will compare this to pregnant women in communities where this strategy was~     not followed, thus where pregnant women received standard care.~      Participants will be pregnant women. There are no direct benefits for participating in the~     study, except the outcome of our research question that is possible health benefits in the~     intervention group. The drugs involved are tested safe in pregnant women from second~     trimester on.~   "
85275|NCT01941251|"~     Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on~     auditory hallucinations as well as negative symptoms of schizophrenia. However, previous~     studies have reported mixed or negative results. Majority of the repetitive transcranial~     magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based~     on scalp site. Recently introduced method, navigated transcranial magnetic stimulation~     (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain~     cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced~     alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG~     guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated~     promising results.~      The aim of the study is to investigate the efficacy of navigated individualized αTMS in~     treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV~     schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The~     patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex~     (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and~     Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test~     battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of~     brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.~   "
85276|NCT01941238|"~     Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump~     offers the advantage of flexibility and precision to administering insulin and has been~     proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there~     are extremely limited studies on the difference between insulin pump compared to MDI on the~     incidence of hypoglycemia and other acute complications during fasting Ramadan~      The investigators hypothesized that insulin pump would be associated with less hypoglycemic~     events during fasting Ramadan compared to MDI without deterioration in glycemic control.~     Results of this study are descriptive but will fill a current gap in knowledge and may~     contribute to development of future guidelines for the management of type1DM during Ramadan.~   "
85277|NCT01941225|"~     The purpose of this study is to investigate the role of the pulmonary vasculature in the~     development and progression of chronic obstructive pulmonary disease (COPD). To accomplish~     this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in~     oxidative stress and lung volumes during exercise will be measured.~   "
85278|NCT01941212|"~     To evaluate the effect of musical therapy before and after gynecological surgeries on pain~     relief following surgery.~      The hypothesis is that musical therapy is effective in pain relief following surgical~     procedures.~   "
85279|NCT01941199|"~     This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to~     investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and~     Metformin IR 1000 mg after oral administration in healthy male volunteers.~   "
85280|NCT01941186|"~     This is a randomized controlled trial aimed at assessing the effectiveness of a patient~     decision aid (PDA) and text message reminder in promoting early intervention referral~     completion when infants and toddlers are identified with a developmental concern in the~     pediatric medical home. Subjects will be randomized to one of two study arms- (1)~     intervention (2) control condition. Subjects in the intervention arm will watch a video PDA~     and will receive a text message reminder approximately 7 to 14 business days after~     enrollment if they agree to the early intervention referral.~   "
85359|NCT01940133|"~     This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and~     the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.~   "
85284|NCT01941134|"~     This study will attempt to determine whether having gastric bypass surgery changes the way~     that the gut absorbs hormones from birth control pills. It is believed that, because gastric~     bypass surgery causes malabsorption of nutrients and some medications, the levels of birth~     control hormones after the surgery will be lower than in women before they have the surgery.~     The investigators will ask several women to take a pack of birth control pills before having~     bypass surgery, and then another pack several months after surgery. The investigators will~     measure hormone levels in the blood. The investigators will also measure outcomes that may~     tell us how well the birth control pills are working, such as ultrasounds of the uterus and~     ovaries, and examination of the cervix.~   "
85285|NCT01941121|"~     This is a CCTG sponsored project to determine if those recently screened for HIV would~     accept assistance to be linked into appropriate health services. After receiving their HIV~     results, high-risk individuals who test negative will have an option to be linked into a~     study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive~     will have an option to be linked into care.~      If they accept, tested individuals will be in contact with an ALERT specialist that will~     help facilitate their linkage. The study's primary analysis will analyze how many HIV~     screened individuals accept the ALERT specialist assistance.~   "
85286|NCT01941108|"~     The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer~     Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care~     for over one year.~   "
85287|NCT01941095|"~     This multicenter, open-label, single arm study will evaluate the safety and efficacy of~     subcutaneous (SC) tocilizumab as monotherapy or in combination with methotrexate or other~     non-biologic DMARDs in participants with active rheumatoid arthritis who are either naïve to~     or have an inadequate response to prior non-biologic or/and biologic DMARDs. The anticipated~     time on study treatment is 52 weeks. Those participants who will complete the 60-week study~     period and have achieved Disease Activity Score (DAS) 28 remission or a good European League~     Against Rheumatism (EULAR) response at 52 weeks will be eligible to enter the extension~     phase until tocilizumab is commercially available and reimbursed in Greece.~   "
85288|NCT01941082|"~     This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in~     patients with wet age-related macular degeneration.~   "
85289|NCT01941069|"~     The overall purpose of this project is to determine whether school personnel implementing a~     two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention)~     program for typically developing children as well as children with, or at risk for,~     externalizing or anxiety disorders can implement the components of the program with the same~     level of fidelity, integrity and clinical effectiveness when they receive a low level of~     support (consultation) from their coaches and supervisors as they can with a high level of~     support (consultation and coaching).~   "
85290|NCT01941056|"~     This phase I trial studies the side effects and the best dose of vaccine therapy in healthy~     volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a~     gene-modified virus may help the body build an immune response and may help prevent~     cytomegalovirus infection.~   "
85291|NCT01941043|"~     The current study will evaluate the antidepressant effect of CERC-301 during 28 days of~     treatment in subjects with MDD who are currently experiencing a severe depressive episode~     despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine~     reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that~     would benefit most from rapid onset, those with recent active suicidal ideation, but not a~     risk to themselves or others and are deemed appropriate for an out-patient study with~     careful safety surveillance. This will allow the study to focus on the antidepressant~     effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset,~     the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be~     examined as a secondary endpoint.~   "
85292|NCT01941030|"~     CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger,~     statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia~     (CLI).~   "
85293|NCT01941017|"~     Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and~     patients with tubal factor infertility~   "
85294|NCT01941004|"~     To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China~   "
85295|NCT01940991|"~     This study will confirm the efficacy and safety of a single topical administration of~     botulinum toxin type A compared to placebo control for the treatment of moderate to severe~     crow's feet lines~   "
85296|NCT01940978|"~     Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines~     such as methylphenidate. Lack of sufficient food intake has been shown to have negative~     effects on weight and height as well as learning and memory.~      There is no current treatment to prevent this loss of appetite except discontinuation or~     reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the~     return of ADHD symptoms.~      The purpose of this study is to compare the effects, good and/or bad, of two doses of a~     drug, cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite~     suppression associated with methylphenidate.~   "
85297|NCT01940965|"~     Primary Objective:~      The primary objective of this study is to assess the overall safety of lixisenatide once~     daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in~     patients with type 2 diabetes in Japan.~      Secondary Objective:~      To assess the effects of lixisenatide in combination with background oral antidiabetic drug~     (OAD) on:~        -  HbA1c;~        -  Fasting plasma glucose;~        -  Body weight.~   "
85298|NCT01940952|"~     The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on~     cognitive function in patients with Alzheimer's disease.~      This study is a randomized, double blind, placebo-controlled multicenter study.~   "
85299|NCT01940939|"~     1. Exploration of rTMS on working memory and cognitive impairment symptoms of~          schizophrenia treatment and mechanism.~        2. Analysis of rTMS high-frequency stimulation to the improvement of negative symptoms and~          psychotic symptoms.~   "
85301|NCT01940913|"~     To assess the tolerability and effect of a probiotic product, when co-administered with~     antibiotics, on the incidence and duration of loose/watery stools following the antibiotic~     treatment in children.~   "
85308|NCT01940822|"~     This study is being done to look at the cardiovascular response, if any, to intake of~     commercially available energy drink. We hypothesize that energy drink consumption compared~     to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus~     of this study is to elucidate the physiological/cardiovascular response to an energy drink~     consumption as compared to a control drink both at rest and during stressful conditions in~     healthy adults.~   "
85309|NCT01940809|"~     This randomized phase I trial studies the side effects and best way to give ipilimumab with~     or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that~     has spread to other parts of the body (metastatic) or cannot be removed by surgery.~     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of~     cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating~     melanoma.~   "
85310|NCT01940796|"~     This research study is trying to determine the safest dose of Brentuximab Vedotin that can~     be given to patients with chronic GVHD and see if chronic GVHD improves.~   "
85311|NCT01940783|"~     One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI)~     recipients was reported to be the placement of the electrode array in the scala tympani. It~     seems that the correct placement of the electrode initially into the scala tympani and~     subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is~     a key factor in achieving good speech perception outcomes. Another important aspect related~     to the performance is the achievement of consistent electrical coverage with the electrode.~     Data reported for electrodes of different manufacturers give depths ranging from 240 - 600~     degrees showing the considerable variation across subjects. The HiFocus mid scala electrode~     was developed to cover one and a quarter turn and with the pre-curved design to be less~     susceptible to variations in individual cochlea dimensions and insertion techniques. A~     further mechanical feature of the pre-curved design is the avoidance of forces against the~     cochlear lateral wall and associated lower susceptibility of the electrode for moving out of~     the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored~     in the field of ENT with the potential to overcome some of the issues associated with the~     conventional CT techniques such as scattering, radiation and low isometric resolution.~     Images with comparable details to those of e.g. micro CTs are possible with much lower~     radiation dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D~     reconstruction, post processing and Brainsfit for registration. Registration is the~     alignment of two scans in the same coordinate system. This enables the identification of~     differences between two images recorded at time x and y. Once accurately superimposed any~     difference between the two images may be identified with an accuracy of 0.2 mm. Using these~     methods, one can assess the stability and the position of the electrode in the cochlea.~      Objective: The primary objectives of this study are to evaluate the feasibility of using~     cone beam CT technique in combination with (high resolution) MRI to identify electrode~     movements following cochlear implant surgery and identify the inter-scalar position of the~     HFms electrode. The secondary objective is to quantify the average insertion depth and~     variations of the HFms electrode~   "
85312|NCT01940770|"~     To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with~     type 2 diabetes mellitus under actual drug use.~   "
85313|NCT01940757|"~     An experimental hookworm infection model is being developed to provide early~     proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult~     hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy,~     hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with~     the investigational product, Necator americanus Larval Inoculum to assess the effect of~     vaccination on infection. The first proposed study will be a feasibility study that will~     consist of administering different doses of the Necator americanus Larval Inoculum to~     healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae)~     that is safe, well-tolerated and results in consistent infection.~   "
85314|NCT01940744|"~     This study is designed to compare the outcomes of two types of manual therapy techniques on~     patients with low back pain. Both immediate- and long-term outcomes will be examined. The~     investigators hypothesize there will be no differences between the two applied treatment~     techniques in immediate and longer-term assessments.~   "
85315|NCT01940731|"~     1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate~          sodium Injection Vial to treat adults with hospital-acquired pneumonia .~        2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of~          Colistimethate sodium.~   "
85316|NCT01940718|"~     It is believed that when androgen (testosterone) levels are below normal there is a~     disturbance of normal bodily functioning that is associated with priapism in some men.~     Conversely, it is believed that testosterone replacement will improve the condition of~     priapism when the testosterone levels are brought to normal. In turn, this will also improve~     psychological well being in men with sickle cell disease (SCD).~   "
85317|NCT01940705|"~     Hearing loss is the second most prevalent service-connected disability among Veterans.~     Hearing aids are the most common technological intervention for hearing loss. The VA,~     therefore, spends a considerable amount of money on them. Despite these expenditures, there~     are some Veterans who do not use their hearing aids successfully. Research has demonstrated~     that this inconsistent use may be related to a patient's inability to effectively take care~     of, and use, hearing aids. The proposed investigation will compare the effectiveness of~     three different tools for enhancing the educational efforts (hearing-aid orientation)~     typically provided by clinical audiologists when dispensing hearing aids. Each of these~     educational tools were developed using established methods for improving patient-provider~     communication. The investigators hypothesize that the use of these tools will result in~     better hearing-aid outcomes for Veteran patients than using the current standard-of-care~     procedures.~   "
85318|NCT01940692|"~     Through a randomized controlled trial, we will compare the intravenous administration of~     tranexamic acid with the intra-articular application after a total hip arthroplasty through~     direct anterior approach.~        -  RCT, prospective study~        -  Academic-monocentric study~        -  Clinical outcome measurements The postoperative blood loss will be the primary outcome.~          Secondary outcomes are~             1. The rate of perioperative and postoperative blood transfusion~             2. The number of blood units transfused~             3. The length of hospital stay~             4. Perioperative given intravenous isotonic fluid~      The Null-hypothesis is that there is no significant difference in postoperative blood loss~     between intra-articular and intravenous administration of TXA.~   "
85342|NCT01940367|"~     The purpose of this study is to determine whether transcutaneous sacral nerve stimulation~     (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective~     therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed~     conventional therapy. Our primary hypothesis is that TENS therapy is a more effective~     treatment option due to ease of use and improved subject compliance with this form of~     therapy.~   "
85319|NCT01940679|"~     Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic~     acid (DHA), have anti-inflammatory properties and other documented beneficial health effects~     that could warrant n-3 fortification of combat rations. However, military combat rations~     must meet rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F),~     which is problematic for natural food sources of n-3s (e.g., oil and fish), which degrade~     when exposed to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating~     freeze dried n-3s with gelatin, can prevent this degradation, and Natick Soldier Research,~     Development and Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated~     n-3 technology to produce n-3 enriched ration items that withstand environmental stressors~     and meet shelf-life specifications for military rations. However, the bioavailability of the~     encapsulated n-3s in these rations is unknown, particularly when they are incorporated into~     high-protein food items and exposed to high temperatures and prolonged storage. In this~     randomized, cross-over study, civilian and/or military personnel will be asked to consume:~     1) a high protein food item enriched with encapsulated n-3s (600 mg) and previously stored~     for 6 months at 100°F; 2) a low-protein food item enriched with encapsulated n-3s (600 mg)~     and previously stored for 6 months at 100°F; 3) a high protein food item with encapsulated~     n-3s (600 mg) that was not subjected to high-temperature and prolonged storage; and, 4) a~     low-protein food item with encapsulated n-3s (600 mg) that was not subjected to high~     temperature and prolonged storage. Serial blood sampling to measure acute changes in the~     circulating fatty acid profile will occur in the hour before and 6 hours after consumption~     of each ration component. The only known risks, which this study presents to participants,~     are those associated with venous catheter placement. The results will help military ration~     developers determine the ration components best suited for n-3 fortification.~   "
85320|NCT01940666|"~     STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone~     [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate~     [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more~     insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with~     excess free androgen index tend to be obese and face the highest metabolic syndrome risk,~     adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT~     group presents with a marginal IR risk, while the excess A4 group has the highest~     antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess~     DHEA-S group have a favorable association with IR.~   "
85321|NCT01940653|"~     Cryopreserved-thawed embryos are often replaced in an artificial cycle, in which the~     endometrium is prepared by exogenous estrogen and progesterone with or without the use of~     GnRH agonist downregulation. The correct duration for exposure to progesterone is still not~     well established. To date, there are no prospective randomized trials available, comparing~     different durations of progesterone supplementation before the date of transfer, with regard~     to treatment outcome (Nawroth).~      In this trial, the investigators want to determine the optimal duration of progesterone~     supplementation: 3 or 5 days before embryo transfer.~   "
85322|NCT01940640|"~     To date, the investigations in the field of the supplementation with DHA in premature babies~     have been focused on the study of neuronal and visual development, giving place to~     contradictory and ambiguous results, because they did not consider in many cases important~     aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and~     precise studies have not been performed in the field of the oxidative damage, inflammation~     and bone development in this population.~      Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a~     mother supplementation with high doses of DHA will increase proportionally the levels of~     this fatty acid in her milk, fact that will allows the premature newborn child receive a~     major dose of this fatty acid, and therefore this way, we will manage to improve the~     neuronal and visual development and to take part on the inflammatory process, oxidative~     damage and its evolution, together with the development or bone mass increase in the~     premature baby.~      Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother~     supplementation during the lactation with high doses of DHA on the development and wellness~     of the premature newborn children. We try to deepen into the effect on the neuronal and~     visual development and to study, for the first time, the effect on the oxidative damage,~     pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn~     babies.~   "
85323|NCT01940627|"~     The General Aim of this study is to verify if a short term supplementation can modulate~     diverse aspects related to the physical regular high intensity activity. To get this general~     aim and following the criteria established by the EFSA Guides, this general aim will be~     divided in specific or concrete aims, and will be studied by its specific analytical.~      First Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the physical performance, resitance , muscle function and~     weakening: maintenance of normal muscle function, maintenance of endurance performance,~     increase in endurance performance/capacity, reduction in the rated perceived exertion/effort~     during exercise, increase in physical performance and maintenance of muscle mass and~     piscological variables that the sportsman suffers before and after the high intensity~     exercise.~      Second Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the biochemical and haematological parameters in~     sportsman.~      Third Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the oxidative stress asociated to a high intensity~     exercise.~      Fourth Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the inflammatory signaling, the activity of diverse pro -~     and anti-inflammatory citokines associated to high intensity exercise.~   "
85324|NCT01940614|"~     Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of~     diabetes insipidus against the standard diagnostic test methods.~   "
85325|NCT01940601|"~     The primary objective of this study is to find the optimal dose of balugrastim by~     characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of~     balugrastim to filgrastim in children receiving chemotherapy.~   "
85326|NCT01940588|"~     Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated~     with a neuropsychoanalytic paradigm.~   "
85327|NCT01940575|"~     - Study design:Multi-center, randomized, double-masked (Unblinded treating investigators),~     intra-individual comparison clinical trial~   "
85328|NCT01940562|"~     Platelet recovery is significantly hampered following umbilical cord blood transplantation~     (UCB). Thus, after UCB transplantations, patients are platelet transfusion-dependent for~     prolong periods of time.~      Eltrombopag is a thrombopoietin-receptor agonist that initiates thrombopoietin-receptor~     signaling and thereby induces proliferation and maturation of megakaryocytes.~      We will evaluate the safety and efficacy of eltrombopag for enhancing platelet engraftment~     in pediatric patients undergoing cord blood transplantation.~   "
85330|NCT01940536|"~     The goal of this study is to determine if the use of tranexamic acid, a safe and effective~     antifibrinolytic, in patients with intertrochanteric hip fractures will result in a~     reduction in blood transfusion rates. Treatment will be administered pre-operatively as well~     as at the time of surgical incision. The primary outcome will be need for blood transfusion.~     Secondary outcomes will include calculated perioperative blood loss, length of stay, cost of~     inpatient care, and rate of adverse events, including DVT, PE, infection, MI,~     cerebrovascular event, need for re-hospitalization or re-operation and 30 day mortality.~   "
85331|NCT01940523|"~     The purpose of this study is to determine whether topical or intravenous administration of~     tranexamic acid during unilateral total knee replacement is more effective at reducing~     bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that~     has been shown to reduce blood drain output and the need for blood transfusions in both its~     topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize~     that IV and topical administration of tranexamic acid will be equally good at reducing the~     loss of blood and the need for transfusion immediately following total knee replacement.~   "
85332|NCT01940510|"~     This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of~     multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802~     in healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and~     rifampin daily from Days 8 to Day 20.~   "
85333|NCT01940497|"~     This non-randomized, multicenter, open-label study will assess the safety and efficacy of~     subcutaneously administered trastuzumab in participants with early and locally advanced~     HER2-positive breast cancer in two sequential cohorts. First 120 participants will be~     treated with subcutaneous (SC) trastuzumab (600 milligrams per 5 milliliter [mg/5mL] vial~     (Cohort A) and the subsequent 120 participants will be treated with SC trastuzumab prefilled~     single use injection device (SID) (Cohort B). Participants from each cohort will receive~     neo-adjuvant or adjuvant chemotherapy consisting of 4 cycles of anthracyclines followed by 4~     cycles of paclitaxel weekly or docetaxel every 3 weeks (q3w) in combination with SC~     trastuzumab (600 milligrams [mg]) q3w and a further 14 cycles of SC trastuzumab (600 mg) q3w~     alone.~   "
85334|NCT01940484|"~     This observational study will evaluate the efficacy and use of Methoxy polyethylene~     glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on~     hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should~     have made the decision of placing the participant on methoxy polyethylene glycol epoetin~     beta in advance and not related to the study. The therapy will be administered by the~     attendant treating physician according to specifications in the package insert guidelines~     and to the routine of the site.~   "
85335|NCT01940471|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive~     and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic~     hepatitis B virus (HBV) infection.~   "
85336|NCT01940445|"~     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2~     clinical sites; each clinic will enroll at least 15 subjects.~      Subjects should present visible wrinkles and/or elastosis requiring treatment.~      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general~     skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75%~     of the subjects.~   "
85337|NCT01940432|"~     This research is primarily to compare effectiveness of electroacupuncture and pelvic floor~     muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress~     urinary incontinence (SUI). The early clinical research is a randomized controlled trial~     (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham~     electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks.~     The result indicates that electroacupuncture is an optimal method for SUI. As a further~     study, this research is a large sample multicenter trial with two parallel arms of~     electroacupuncture group and pelvic floor muscle training group. The primary purpose is to~     value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and~     amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is~     to evaluate safety of electroacupuncture therapy, and compare acceptance of~     electroacupuncture treatment and pelvic floor muscle training.~   "
85338|NCT01940419|"~     In Denmark, 4400 women annually undergo hysterectomy on benign background (surgical removal~     of the uterus). 10% of these women experience bleeding complications. The drug Tranexamic~     Acid (Cyklokapron) has showed significant reduction of bleeding in relation to other types~     of surgery. The hypothesis of this study is that Tranexamic Acid could also reduce the~     operative bleeding associated with benign hysterectomy. The study will be carried out as a~     randomized, placebo-controlled national multicenter trial~   "
85339|NCT01940406|"~     The current study is designed to test the hypothesis that targeted electrical stimulation~     will result in upper limb tremor reduction in ET and PD patients.~   "
85340|NCT01940393|"~     The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in~     the management of patients with rhinitis and the first line of treatment in patients with~     urticaria. Currently, the use of antihistamines has become popular due to its excellent~     safety profile and clinical efficacy, however to the investigators knowledge, there are no~     studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of~     tropical Latin America. The investigators main interest is to evaluate if skin test~     inhibition correlates with the clinical effect of five anti-histamines.~   "
85341|NCT01940380|"~     Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a~     deterioration of the bone architecture resulting in an increased risk of fracture,which is~     directly related to the lack of estrogen and also associated with a variety of genetic and~     acquired factors. Previous studies have found that POP molecular regulation mechanism of~     kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.~      This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and~     healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the~     kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.~   "
85343|NCT01940354|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt peripheral IV placement and higher clinician and patient~     satisfaction compared to Conventional IV Catheters.~   "
85345|NCT01940328|"~     The purpose of this study is to evaluate the lung Doppler signals in left HF patients with~     and without pulmonary congestion (i.e. decompensated left HF patients and compensated left~     HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF~     controls), in order to determine the diagnostic value of this non-invasive method in CHF. If~     this method will prove to be of diagnostic value, it could potentially be used to diagnose~     and monitor CHF patients in both inpatient and outpatient settings.~   "
85346|NCT01940315|"~     This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter~     investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.~   "
85347|NCT01940302|"~     Due to metabolic disorders and dietary restrictions, patients with diabetes may have~     different degrees of malnutrition. The primary objective of this study is to investigate~     whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve~     metabolic parameters in patients with type 2 diabetes.~   "
85348|NCT01940289|"~     The primary aim is to examine whether there is a consistent range of pressure threshold~     values for the asymptomatic foot.Previous studies established the inter/intra-clinician~     reliability of pressure threshold measuring and have established a normative range of values~     within the trunk and upper body. Since the establishment of these values, pressure threshold~     testing has been used extensively in the head, neck, shoulders and spine as a clinical tool~     and a research aid. There has been little work using it in the lower limb and there are no~     guideline measurements for the clinician. By establishing a range of values for the~     foot,this study will enable the clinician to employ pressure threshold measuring as a~     clinical tool to easily and accurately identify areas of dysfunction and to objectively~     measure the effectiveness of treatment. It will allow the clinician to establish a degree of~     improvement or deterioration as it occurs in a patient's condition.~      Secondary aims are to examine whether there is a correlation between visual analogue pain~     scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain.~     This will help validate the tool for use in the foot. Since VAS is well documented and~     validated, this study will examine whether there is a correlation between VAS and algometry~     and whether there are gender or age differences in the range of measurements obtained. These~     areas have been addressed in previous studies but results have been contradictory and~     inconclusive and none of the previous studies focused on the foot.~      An asymptomatic group of 384 subjects & symptomatic group of 160 subjects shall be selected~     from those attending a podiatric clinic for routine foot care who meet the inclusion~     criteria . Outcome me will be algometric pressure threshold testing, visual analogue pain~     scales and foot function index questionnaires.~   "
85349|NCT01940276|"~     The primary goal is to prospectively estimate the median radiographic PFS of African~     American and Caucasian men with mCRPC to abiraterone acetate and prednisone.~   "
85350|NCT01940263|"~     Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty~     liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve~     features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and~     inflammation in rodents. The purpose of this study is to investigate whether purified~     anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic~     biomarkers in adults with features of NAFLD.~   "
85351|NCT01940250|"~     Hand foot and mouth disease (HFMD) is a common infectious disease caused by a number of~     different viruses - a small proportion of children infected with a particular type of~     enterovirus (EV71) develop neurological and systemic complications that may prove fatal.~     Very large epidemics of EV71 related HFMD have occurred across Asia in recent years; in~     2011, in excess of 100,000 Vietnamese children were diagnosed with HFMD and 164 died.~      In children with severe HFMD the particular part of the brain that regulates the heart,~     blood circulation, and breathing responses can be affected. Management of this complication~     is very difficult and we currently use an expensive drug (milrinone) that is hard to obtain~     and has significant side effects, without having good evidence that it is effective.~      Magnesium sulphate (Mg) is a cheap, readily available drug that has been used in other~     diseases with similar complications, and we have preliminary data from a small case series~     that suggests it might be a good treatment for HFMD patients with signs indicating this type~     of brain involvement.~      We think that early intervention with Mg, when signs of brain involvement are still~     relatively mild, will control this problem better than waiting until it is well established~     and giving milrinone as at present, and this in turn may prevent progression to severe~     disease. The aims of the project are to evaluate the effects of Mg on hypertension, signs of~     brain dysfunction, outcome (death or neurological sequelae), changes in a variety of blood~     and urine components, and measures of cardiovascular function, in severe HFMD.~      The study design is a randomized double-blind placebo-controlled clinical trial. Children on~     the pediatric intensive care unit with a clinical diagnosis of hand, foot and mouth disease~     will be eligible for enrolment if the blood pressure exceeds the internationally recognized~     threshold for Stage 1 hypertension, they exhibit at least one other sign of brain stem~     dysfunction, and there is written informed consent by a parent or guardian.~      According to the randomization, patients will receive an initial loading dose followed by a~     maintenance infusion, of either Mg or identical placebo for 72 hours; all staff involved in~     patient care will remain unaware of the treatment allocation, but staff from another~     department will monitor Mg blood levels to ensure safety and adequate dosing. A total of 190~     patients (95 in each arm) will be recruited.~   "
85352|NCT01940237|"~     There is now overwhelming evidence documenting the efficacy of psychotherapy in the~     treatment of depression in the general population. Surprisingly, however, given the high~     prevalence of depression in cancer patients, there are very few studies on the efficacy of~     psychotherapy in this population. Published studies of psychotherapy in cancer patients~     generally include patients with high heterogeneity of psychiatric diagnosis and frequently~     include patients without a psychiatric diagnosis, with the aim of preventing the appearance~     of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy~     and specificity of these interventions. Specifically, the efficacy of psychotherapy for~     major depression in patients with cancer is unknown.~   "
85353|NCT01940224|"~     The purpose of this study is to evaluate how effective is the preoperative administration of~     pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic~     colorectal surgery~   "
85354|NCT01940198|"~     This observational study will aim to determine long-term atazanavir experience in a high HIV~     caseload primary care practice in Sydney, Australia.~   "
85355|NCT01940185|"~     A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter,~     single-arm study, with patients as their own control to monitor the safety and efficacy of~     the LINX implant procedure and device in a post-approval environment to supplement existing~     safety and efficacy data.~   "
85356|NCT01940172|"~     This is a dose escalation study in female subjects with relapsed ovarian cancer (including~     epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer).~     Approximately 30 to 40 subjects will be administered a combination of conatumumab and~     birinapant.~      In the initial dose-escalation stage of the study, adult female subjects will receive~     conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to~     determine the MTD of birinapant when administered with a fixed dose of conatumumab.~      In safety expansion stage, adult female subjects will receive conatumumab in combination~     with birinapant at the MTD of the combination.~   "
85357|NCT01940159|"~     This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral~     dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles~     of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.~   "
85360|NCT01940120|"~     Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6,~     12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified~     retrospectively from the patients screened for the HRR who did not enroll; patient survival~     determined at 12 months. NCT00209274 Intended use Percutaneous reduction of clinically~     significant mitral regurgitation in symptomatic patients who are considered to be high risk~     for operative mortality (high surgical risk).~   "
85361|NCT01940107|"~     To observe the effect of domiciliary physiotherapy on the upper limb applied during the~     period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer.~     The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There~     was significant difference between the ipsilateral and contralateral limbs for flexion,~     abduction and external rotation. There was no difference in perimetry in either group~   "
85362|NCT01940094|"~     This study is a multi-center randomized controlled trial to evaluate the effects of using~     low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will~     be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the~     duration of the study (approximately six months) or until a study endpoint.~   "
85363|NCT01940081|"~     Rationale: Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major~     cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that~     effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms~     of VA in NICM may allow more effective, individualized and substrate-based therapies to be~     developed. In addition, risk stratification in NICM needs to be improved so that therapies~     can be allocated more efficiently.~      Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and~     electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA~     based on the identified substrate. 2) To improve risk stratification for VA and sudden~     cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression~     in NICM.~      Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow~     more effective, individualized and substrate-based therapies to be developed.~      Study design: A prospective cohort study.~      Study population: The study population will consist of three groups (A, B and C): NICM~     patients with documented VA, suspected VA or intermediate to high risk for VA (according to~     established criteria) who are not referred for cardiac surgery (group A), NICM patients with~     documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery~     (group B) and a control group consisting of patients without NICM who are referred for~     cardiac surgery (group C).~      Evaluation: All patients will be evaluated according to current standards for patients with~     NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and~     contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional~     recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac~     venous and peripheral venous) for collagen turnover markers will be taken from all patients.~     123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and~     endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be~     performed in group B and C.~      Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative~     electrophysiologic study will be performed in patients with subepicardial late enhancement~     on MRI or induced VA suspected for an subepicardial origin.~      Main study parameters/endpoints: The main study parameters are extent, location and pattern~     of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of~     VA, type of induced VA, spontaneous VA and type of spontaneous VA.~   "
85364|NCT01940068|"~     The purpose of this study is to evaluate the impact of a new Amino-acid based formula on~     allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to~     extensively hydrolysed formulas;~   "
85365|NCT01940055|"~     Goal:~      The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated~     rehabilitation that provides an adapted, blended approach among older adults with balance,~     mobility, and cognitive impairments.~      Study Objective:~      Examine the feasibility and benefits of a novel dual-task intervention to address mobility~     and cognitive decline with age using engaging interactive video games during treadmill~     walking and recumbent cycling.This will include evaluation of the effects of two~     interventions, one using treadmill walking and the second a recumbent cycle ergometer on~        1. Core balance~        2. Cardiac fitness, exercise endurance~        3. Gaze control~        4. Gait performance measure (walking stability and spatial-temporal gait parameters)~        5. Specific executive cognitive function (processing speed, cognitive inhibition, working~          memory)~        6. Dual task function during treadmill walking~      Hypothesis:~        1. Dual-task exercise program will improve core balance and walking function to a greater~          extent in the Treadmill walking group compared to recumbent cycle group.~        2. Executive function will improve equally in both the treadmill walking and recumbent~          cycle group.~        3. Dual task exercise programs will have significant effect on gaze stability and cardiac~          fitness equally for both the treadmill and recumbent cycling groups.~   "
85366|NCT01940042|"~     The investigators think that a simple maneuver at laparascopic surgery to reduce the~     postoperative pain.~   "
85367|NCT01940029|"~     Neurosurgical ICU patients often receive hyperosmotic diuretics or cerebrospinal fluid (CSF)~     drainage to decrease their intracranial pressure. It is also common to keep them under~     normovolemia or mild hypervolemia status for stable cerebral perfusion pressure (CPP). These~     patients have large urine output on average, and can decrease the reabsorption of specific~     medicines by renal tubules. Besides, hypervolemia status might increase the volume of~     distribution for hydrophilic medicines, and lower their serum concentration. Therefore, the~     pharmacokinetic characteristics in this population may be different from general population,~     which impacts the efficacy and toxicity of medicines with narrow therapeutic index.~      Vancomycin is used mainly for MRSA (methicillin-resistant S. aureus) infection, and~     possesses a significant place of therapy in treatment of neurosurgical patients'~     post-operation infection. The serum concentration of vancomycin exhibits a clear relevance~     to its efficacy and toxicity. From the investigators' preliminary research of the~     disposition of vancomycin in neurosurgical ICU patients, the investigators found that their~     vancomycin serum concentrations were lower than expected, which can be attributed to their~     40% higher mean vancomycin clearances than that of neurosurgical general ward patients.~     However, no definite mechanism leading to this phenomenon was confirmed.~      In this study, the investigators prospectively recruit a cohort of adult neurosurgical ICU~     patients to validate the investigators' preliminary pharmacokinetic parameter models for~     vancomycin. Furthermore, the investigators will also demonstrate the contribution of~     different vancomycin elimination routes, renal and CSF drainage eliminating routs, to its~     total clearance, and the relationship between vancomycin renal clearance and creatinine~     clearance. Exclusion criteria include renal failure, unstable renal function, obesity, shock~     status, third space fluid accumulation, burn and pregnancy. The models to validate are used~     for empirical vancomycin dosage calculation. Therapeutic drug monitoring (TDM) is conducted~     after vancomycin serum concentration achieves steady state, and the predicted and observed~     serum concentration of vancomycin are compared to evaluate the consistency. On the other~     hand, vancomycin excreted from urine and CSF drainage fluid would be calculated to see their~     independent contribution for total vancomycin clearance. Meanwhile, the investigators try to~     investigate the mechanism for renal elimination of vancomycin by its association to~     creatinine clearance values calculated from urine creatinine concentration data.~      Bringing all the information together, the investigators hope to provide helpful information~     for the clinical pharmacokinetics of vancomycin therapy in neurosurgical patients, and to~     optimize empirical vancomycin dosing and improve treatment success. Through this study, the~     investigators also wish to understand the possible pharmacokinetic change of other medicines~     in this population, and provide an important source of reference for clinical treatments.~   "
85368|NCT01940016|"~     This randomized clinical trial studies the feasibility of tailored physical activity~     intervention that is administered using Interactive Voice Response technology and cell~     phones. Interactive voice response and health coach support may motivate overweight~     postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast~     cancer.~   "
85369|NCT01940003|"~     The purpose of this study is to verify the efficacy of an aquatic physical exercise program~     on GDM control and adverse maternal and fetal outcomes.~   "
85370|NCT01939990|"~     The purpose of this study is to demonstrate the safety and effectiveness of the study drug~     Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary~     Disease (COPD).~   "
85374|NCT01939938|"~     Our group has recently found that the choice of positive airway pressure mask can~     significantly affect the pressure required to adequately treat sleep disordered breathing.~     The goal of this study is to visualize the upper airway in the retropalatal and retroglossal~     region while using both oronasal and nasal masks with CPAP in order to investigate~     differences in upper airway dynamics that may occur between these two mask types.~   "
85375|NCT01939925|"~     The purpose of this randomised controlled trial is to compare a new standardised summary~     format for presentation of synthesised evidence from systematic reviews for the public (a~     new plain language summary format) to the current format used in Cochrane systematic~     reviews. The study will evaluate if the new presentation improves understanding about the~     benefits and harms of an intervention, if it improves the accessibility of the information,~     and if it is preferred over other versions by the public over the current format.~   "
85376|NCT01939912|"~     The isolated response of the carotid bodies to local stimulation with adenosine has not been~     researched in humans. There are single reports indicating that intravenous administration of~     adenosine causes hyperventilation through activating the carotid bodies.~      Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid~     artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only~     slightly influence the standard scheme of the procedure.~   "
85377|NCT01939899|"~     This is an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of~     oral IXAZOMIB in adult patients with follicular lymphoma (FL) that is relapsed and/or~     refractory to prior treatment.~   "
85378|NCT01939886|"~     Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the~     first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity~     to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the~     development of parasite resistance against AL. Clinical trials in Asia showed that~     mefloquine-artesunate (MQ-AS) may be more efficacious than AL and may have a more pronounced~     beneficial effect on post-treatment malaria transmission. MQ-AS is registered and used in~     Kenya but there have been no reported direct comparisons of AL and MQ-AS with clinical and~     transmission endpoints (i.e. adequately clearing parasites and preventing transmission to~     mosquitoes).~      Screening for molecular markers that are related to parasite susceptibility to ACT drugs and~     to post-ACT treatment malaria transmission can assist strategies to prevent the development~     and spread of ACT resistance.~      In the current study, we compare AL and MQ-AS for the treatment of uncomplicated malaria.~     Our endpoints are i) clinical efficacy, ii) post-treatment gametocytaemia by molecular~     techniques.~      In the current study, the investigators compare AL and MQ-AS for the treatment of~     uncomplicated malaria. The investigators endpoints are~      clinical efficacy post-treatment gametocytaemia by molecular techniques~   "
85379|NCT01939873|"~     The use of fundal pressure in management of the second stage of labor is controversial. The~     aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the~     second stage of labor and to examine the related neonatal and maternal outcomes.~   "
85380|NCT01939860|"~     Hypertension is a major health problem, however its control is unsatisfactory. One of the~     reasons for such a high prevalence of this disease includes poor patient compliance to~     treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their~     blood pressure medication by six months and 50% by 12 months.~      The UK government is keen to encourage community pharmacists to play an active role in~     participation of services that can improve patient adherence to their medications. The New~     Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services~     which fund community pharmacists to review and explain medicine use to patients, with~     hypertension a common condition for which advice is given within these schemes. Within these~     schemes, advice is verbal and unstructured, with no specific written information provided on~     drugs or the disease being treated.~      This study aims to determine whether structured information provided to participants~     verbally and in writing by community pharmacists about blood pressure and current~     medicine(s) within NMS and targeted MURs will be retained and will be associated with~     improved hypertension control. Participants will be recruited from people eligible for NMS~     and MURs and attending community pharmacies.~   "
85381|NCT01939847|"~     This study will test the feasibility of identifying patients who could benefit from tumor~     molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of~     the identification of possible actionable mutations that are not just biologically~     interesting but are clinically relevant. The investigators will also examine the outcome~     data from patients who followed the Molecular Profiling Tumor Board suggestion compared with~     those who did not.~      When the tissue studies are done, an additional group of patients will be enrolled to test~     if the same is possible in blood samples.~   "
85382|NCT01939834|"~     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for~     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate~     the system's ability to significantly improve blood glucose levels. One component of this~     study is evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system~     can prevent hypoglycemia during and following exercise more efficiently during a 40 hour~     trial. Another component of this study is evaluating AAA Control overnight only in 5~     consecutive overnights. This protocol represents a culmination of prior clinical trials in~     development of this AAA system and benefits from the synthesis of those components.~   "
85383|NCT01939821|"~     The investigators are planning to do a cluster randomized trial to test the effect of~     different educational programs for staff according to nursing home patients FI (fecal~     incontinence). Since there are very few published trials of treatment of FI in older people,~     and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously~     evaluated continence education program for staff concerning continence care, a pilot study~     is necessary. The aim for the pilot study is to evaluate feasibility, acceptability and~     adherence according to the educational intervention, methods used and outcome measures. This~     is designed to be an external pilot study. External pilot studies are small scale versions~     of the main study which are not intended to be part of the main study. The pilot~     intervention period is 3 month.~   "
85536|NCT01937806|"~     To prove that a study drug is noninferior to a control drug with a proportion of subjects~     who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after~     48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic~     hepatitis B patients~   "
85384|NCT01939808|"~     Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp~     penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired~     surgically with sutures (stitches). After repair, a splint is applied to the fingers, hand~     and wrist for six to twelve weeks to protect the repair while the tendon heals and regains~     its normal strength.~      Most rehabilitation protocols use a splint in which the wrist position is kept straight~     (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back~     (extended) and have made the argument that this may improve outcomes, as experimental data~     suggests that splinting the hand with the wrist extended increases the range of movement of~     the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon~     sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse~     effects from splinting hands with the wrist extended, and no evidence tells us which wrist~     splint position is better (a state of clinical equipoise or apparently equivalent outcomes).~     This randomised trial aims to produce this evidence, and therefore improve functional~     outcomes for patients in future.~      We propose to carry out a study to compare the outcomes (grip strength and range of~     movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a~     neutral position and the other splinted in an extended position during their postoperative~     rehabilitation. No changes will be made to patient assessment and management,the surgery~     undertaken and the rehabilitation regime other than those to splint position. Previous work~     suggests that both positions are safe and effective. Informed consent will be obtained from~     all patients enrolled in the trial, and we aim to find out if the extended splint position~     produces better functional results.~   "
85385|NCT01939795|"~     The investigators hypothesis that exercise training would potentiate the effects of cardiac~     resynchronization therapy in heart failure patients.~   "
85386|NCT01939782|"~     This study is undertaken to explore whether compared to extension of overnight fast until~     lunch versus the breakfast consumption influence the oscillation of the metabolic clock gene~     expression in peripheral blood cells (PBC), at noon and after isocaloric lunch in type 2~     diabetic patients.~   "
85387|NCT01939769|"~     Background:~      - Research has shown that one exercise session may improve a person s ability to recall~     information they learned before the exercise. Knowing how exercise changes brain activity to~     improve memory can help researchers understand how memory works and how to improve it in~     people with memory problems. This study compares two kinds of exercise on a stationary bike~     for their ability to temporarily improve memory on certain tests. Researchers will look at~     the effect of exercise on body chemistry by drawing blood and collecting saliva.~      Objectives:~      - To understand how a single session of exercise affects memory testing in healthy people~     and people who have had traumatic brain injury (TBI).~      Eligibility:~        -  Adults ages 18 through 45 with TBI.~        -  Healthy adult volunteers, ages 18 through 45.~      Design:~        -  Participants will be screened with medical history and physical exam. This will take~          about 1 hour.~        -  Participants with TBI will also be screened with a test of their memory. This will take~          another hour.~        -  Visit 1 will take about 3 hours. Participants will:~      <TAB>- Have a tube inserted in their arm for drawing blood during the tests.~      <TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer~     questions.~      <TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.~      <TAB>- Exercise on a stationary bike.~      <TAB>- Take the memory tests again.~      - Visit 2 will take place 1 week later. Participants will take the memory tests only.~   "
85388|NCT01939756|"~     Baobab oil is often used in traditional medicine as antipyretic, antioxidant,~     anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in~     a short time improving tone and elasticity. We want to evaluate the effects of intravesical~     Baobab oil in patients with BCG-induced lower urinary tract symptoms.~   "
85389|NCT01939743|"~     Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode~     of investigation for prostate cancer in current urology practice. It is considered a minor~     procedure, which most of the patients tolerate, however 20% of patients refuse to undergo~     the redo procedure without any analgesia or anesthesia but on the other hand, some authors~     reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity.~     Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators~     involved in local pain.The purpose of this study is to find out the role of rectal~     administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating~     intra and post procedural pain in prostatic biopsy with adequately calculated sample size~     and excluding the patients with contraindication to procedure or diclofenac administration~     as these were the shortcomings of previous studies.~   "
85390|NCT01939730|"~     The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8)~     and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better~     than using rituximab alone to treat follicular B-cell lymphomas. The safety of this~     treatment will also be studied.~   "
85391|NCT01939717|"~     Primary aim is to conduct a pilot trial to determine:~        1. The feasibility and efficiency of randomisation procedures and study design~        2. If recruitment rates are sufficient to adequately power a larger trial~      The secondary aim is to determine the efficiency of set dancing in comparison to a control~     for people with Patkinson's disease.~   "
85392|NCT01939704|"~     It is increasingly clear that the environment in which a child lives, plays, and goes to~     school has a significant impact on their health. With the implementation of a Community to~     Clinic Linkage Program (CCLiP) in the SFGH Pediatrics Clinics, we will routinely address~     Social Determinants of Health when families present. We will randomize patients to receive~     either the CCLiP intervention or standard of care. We will evaluate programmatic outcome,~     health care utilization data and return on investment data. We hypothesize that by~     addressing the environmental and social factors that contribute to health within the setting~     of the medical home, we will be able to better connect families to community resources,~     enable more appropriate use of healthcare resources, improve health status, and enhance~     patient satisfaction.~   "
85393|NCT01939691|"~     Cystoid macular edema is a condition in which there is swelling in the macula, the part of~     the retina that gives you your best vision. This swelling can cause your vision to get bad.~     When it is diagnosed early and treated, you vision usually can be preserved. However, if the~     swelling goes untreated for several months, it can cause permanent vision loss.~      We think that the two eyedrop regimens in this study, difluprednate or nepafenac plus~     prednisolone, might be effective in treating uveitic macular edema. Patients who enter this~     study are being randomized to one of the two regimens and are being followed for one month.~   "
85425|NCT01939275|"~     This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic~     acid (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in~     studying patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu~     64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose~     the best treatment.~   "
85394|NCT01939678|"~     The purpose of this study is to investigate whether mutations in genes coding for~     Na/Pi-cotransporters are associated with aortic valve calcification. A patient population~     with premature aortic valve calcification treated with aortic valve replacement will be~     screened for mutations in these specific genes. Furthermore, aortic valve tissue received~     from the operations, will be examined for the presence of Na/Pi-cotransporters, and for~     molecular characterization of the transporters.~   "
85395|NCT01939665|"~     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method~     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near~     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are~     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the~     cell membranes, and create 'nanopores', after which the cell dies through loss of~     homeostasis.~      The purpose of this study is to investigate the safety of percutaneous IRE in the treatment~     of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are~     feasibility and efficacy of IRE based upon symptomatic response and tumor response.~      Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma~     (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and~     ultrasound guidance. After IRE, patients will be carefully monitored and any (serious)~     adverse events are registered. Follow-up will consist of frequent CT scanning, as well as~     serum CA19.9 tumor marker.~      We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor~     control, without causing severe complications.~   "
85396|NCT01939652|"~     Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a~     significant number of complications involving respiratory, cardiovascular, gastrointestinal~     and central nervous system, and mortality ranging up to 5%. In our study, we tested the~     hypothesis that intraoperative and postoperative intravenous restrictive fluid regime~     reduces postoperative morbidity and mortality and improves the outcome of the treatment of~     minilaparotomy AAA repair.~   "
85397|NCT01939639|"~     Social touch can convey the most potent and salient of socio-emotional signals. While the~     hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of~     grooming in some other social species, its modulatory influence on human interpersonal touch~     is unknown. The investigators expect that OXT augments the hedonic value of touch and that~     this behavioral effect is paralleled at the neural level by an increased response in brain~     areas mediating rewarding aspects of social touch.~   "
85398|NCT01939626|"~     The purpose of this study is to compare human embryo in vitro development in sequential and~     single-step culture medium using time-lapse imaging.~   "
85399|NCT01939613|"~     The present study was to evaluate the effectiveness of colloid compared with crystalloids~     for fluid resuscitation in critical burn patients with total burn surface area ≥50%.~   "
85400|NCT01939600|"~     Dietary fiber is a type of carbohydrate which is not digested in the human small intestine.~     Whole grains are a source of dietary fiber that are used to promote health; however, using~     whole grains in commercial products results in a different taste and/or texture than the~     usual products made from refined grains. Thus, other types of high-fiber ingredients have~     been developed which can be incorporated into food products with less effect on their taste~     and/or texture. An example of this is resistant starch, defined as starch which is not~     digested in the human small intestine. The digestibility of starch is usually determined~     in-vitro; however, there is evidence that such methods may overestimate the amount of~     resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the~     ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best~     in-vivo method of starch digestibility. The subjects collect ileal effluent during the day~     during which time they consume a polysaccharide-free diet. There is evidence that resistant~     starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after~     consumption. The purpose of this study will be to compare the carbohydrate content recovered~     in ileal effluent of 10 subjects with a conventional ileostomy.~   "
85401|NCT01939587|"~     This is a single-center, double-blind, randomized trial utilizing a three-period, balanced~     block design, with each period comprising a unique study product administration. The~     treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered~     capsule. The study includes a screening visit, a selection visit, three visits for the~     randomized treatment sequence, and an end-of-study follow-up visit, spanning through a~     65-day maximum study duration. The study will be conducted on 18 male or female adults aged~     ³18 years, with a diagnosis of stable, mild to moderate asthma as per GINA guidelines, with~     no smoking or less than a 5 packs-years smoking history history, responsive to AMP airway~     challenge as determined in the selection visit.~      The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at~     the three treatment visits. FeNO, sampled at three time points at each treatment period~     visit, will be a exploratory variable. Safety assessment will include monitoring of adverse~     events, physical examination, vital signs, EKGs, spirometry, serum and urine pregnancy~     tests, and laboratory determinations. Blood sampling at a time-point series will provide~     pharmacokinetics data.~      The primary variable of the study is PC20, mg×mL-1. The PC 20 distributions will be analyzed~     by treatment using ANOVA for repeated measurements, followed by post hoc pairwise~     comparisons as appropriate. Other analyses will comprise FeNO, pharmacokinetics, data sets~     generated from baseline characteristics and safety assessments, and discretionary expiratory~     analyses to evaluate the influence of baseline and clinical covariates on the primary~     variable.~   "
85412|NCT01939444|"~     The overall is aim of this pilot study is to give a preliminary estimation of key parameters~     of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be~     used to design a well justified protocol for the final estimation of these parameters:~        -  Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy~          volunteers~        -  Preliminary estimation of the maximum serum concentration (Cmax) of this formulation~        -  Preliminary estimation of the time to maximum serum concentration (Tmax) of this~          formulation~        -  Safety of the formulation~   "
85449|NCT01938963|"~     This study will see if education of village doctors and aging workers in identification and~     management of hypertension and depression, using standardized procedures,consultation with a~     psychiatrist as needed, and collaborations between the village doctor and aging worker in~     care elderly patients in the village better achieve better outcomes for their depression and~     high blood pressure than usual care.~   "
85402|NCT01939574|"~     This is a single-center, open-label, single arm study to explore whether potential image~     biomarkers correlate with efficacy of bevacizumab combined with conventional therapy in~     newly diagnosed glioblastoma.~      Despite the increase in therapies available, the median survival of patients with~     glioblastoma multiforme (GBM) remains less than 15 months.~      The phase III pivotal study in newly diagnosed GBM also met its co-primary endpoint of~     progression-free survival (PFS) which further confirm the efficacy of bevacizumab in GBM.~      Early predicting the efficacy of bevacizumab combined with conventional therapy in newly~     diagnosed glioblastoma could help us to identify the suitable patients to receive suitable~     treatment in GBM. Thus, characterizing the blood flow and blood volume in the tumor and~     their changes during therapy might provide information on vasculature growth or~     collapse,edema formation, tumor growth, and/or cell death(necrosis) .We decided to~     investigate whether the estimation of blood circulation in tumor, using MRI,PET could be~     used as a surrogate marker to predict the early response of GBM to bevacizumab.~      Several previous studies have demonstrated that the relative cerebral blood volume (rCBV)~     correlated with the histologic grade of gliomas and investigated the prognostic value of the~     tumor CBV for survival.In current study, We hypothesized that, the temporal changes during~     anti-angiogenesis therapy in specific regions of high and low perfusion in glioblastoma~     might predict the efficacy of bevacizumab.Since there is no mature PET tracer directly image~     Vascular Endothelial Growth Factor (VEGF) in China,we use~     18F-Galacto-arginine-glycine-aspartic acid (RGD)—— a new tracer for PET imaging of αvβ3 by~     testing Standardized uptake value mean (SUVmean),Standardized uptake value max (SUVmax) and~     tumor to non-tumor tissue ratios (T/NT) to indirectly reflect the VEGF expression. The~     integrin αvβ3 is an important receptor affecting tumor growth, local invasiveness, and~     metastatic potential. Specifically, αvβ3 is highly expressed on activated endothelial cells~     during angiogenesis.~      Therefore, in the pilot study, we use dynamic contrast enhanced magnetic resonance imaging~     (DCE-MRI),dynamic susceptibility-contrast magnetic resonance imaging (DSC-MRI) and~     18F-Galacto-RGD PET to explore the potential image biomarkers of bevacizumab used in newly~     diagnosed glioblastoma.~   "
85403|NCT01939561|"~     Myotonia is a functional limiting symptom where the muscle stiffens on action leading to~     arrest of movement. Pharmacological treatment may make the difference between a physically~     restricted and a normal life. Today, patients with myotonia are treated with Mexiletine a~     medications resulting in adverse events up to 40 % and which very expensive and difficult to~     obtain.~      Our clinic has, forced by the above problems related to Mexiletine, treated a few patients~     with the drug Lamotrigine with pronounced positive effect in all. Lamotrigine belongs to the~     same category of drugs as Mexiletine but has fewer and milder side effects. Based on the~     similarities of the 2 drugs in pharmacological action and the positive experiences~     investigators are convinced that Lamotrigine will show a positive effect if evaluated in a~     broader scale. Due to the advantages of Lamotrigine compared to Mexiletine investigators~     find it of outmost importance for patients that this drug is assessed formally to establish~     Lamotrigine as a treatment choice for myotonia. Investigators believe that this will~     potentially make a huge difference in life quality for persons with myotonia. Investigators~     aim at investigating the efficacy and tolerability of Lamotrigine in the treatment of~     myotonia in a randomized doublet blinded placebo controlled crossover study.~   "
85404|NCT01939548|"~     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of~     sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment~     period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure~     change in symptoms for PF-02545920 from baseline compared to placebo.~   "
85405|NCT01939535|"~     The purpose of the study is to evaluate the value of MRI in preoperative stratification of~     endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary~     approach by gynaecologists, urologists or/and abdominal surgeons.~   "
85406|NCT01939522|"~     Children/ young people with diabetes may be at a higher risk of acquiring certain~     infections. These infections include those caused by a bacterium called the pneumococcus~     which can cause pneumonia, meningitis and ear infections. In the UK older children with~     diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for~     short). Although PPS23 causes a good immune response in children over 2 years of age it is~     not actually known how well PPS23 protects against infection in children of any age. In~     addition there is some data in adults and children that PPS23 may result in a reduced~     response to future doses of pneumococcal vaccines (hyporesponsiveness). Because of the lack~     of information on how well PPS23 protects and potential hyporesponsiveness the investigators~     would like to study the use of an alternative vaccine against pneumococcus called Prevenar13~     (or pCV13). This vaccine is known to be safe and to work well in babies and young children~     and there have been no concerns about hyporesponsiveness. It has been approved for use in~     children up to 17 years of age but there is little information on the size and duration of~     immune response to PCV13 in children aged 6 years and older.~   "
85407|NCT01939509|"~     At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory~     could improve the peripheral arterial perfusion and could have a greater antihypertensive~     effect. At the same time, this could carry objectifiable improvements in the vascular tree,~     such as the level of arterial stiffness.~      This study attempts to mark the hemodynamic differences in the same individual with~     hypertension and metabolic syndrome who will be exposed to both drugs at different moments.~     Parameters will be objectified with impedance cardiography, pulse wave velocity and central~     blood pressure assessment before and after taking each one of the drugs. The results will be~     compared to the baseline data and between themselves.~   "
85408|NCT01939496|"~     The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood~     pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes~     mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents.~     Overall safety and tolerability of canagliflozin will be assessed.~   "
85409|NCT01939483|"~     This pilot clinical trial studies irinotecan hydrochloride in treating patients with breast~     cancer and brain metastases that progressed after whole brain radiation therapy or~     stereotactic radiosurgery. Drugs used in chemotherapy, such as irinotecan hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
85410|NCT01939470|"~     Native American women may be considered high risk for osteoporosis due to lifestyle factors~     and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the~     prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate~     their rate of bone loss; 3) to assess the relationship between lifestyle factors,~     inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4)~     determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2~     follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA~     and logistical regression.~   "
85411|NCT01939457|"~     Women presenting with incomplete abortion and eligible for treatment with misoprostol were~     offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study~     hypothesises that women can successfully be treated with misoprostol alone as first line~     treatment.~   "
85413|NCT01939431|"~     Background:~      - Podoconiosis is a disease of the lymph vessels in the legs and feet. It is caused by~     long-term barefoot exposure to irritant soils, such as those in volcanic areas. It causes~     severe swelling and disfigurement, as well as infection and chronic pain. It mostly affects~     people who live in tropical Africa, Central and South America, and India. The reasons why~     some people develop this disease and others do not is not well understood. Researchers want~     to study people with the disease and healthy volunteers in Ethiopia. They will collect skin~     and blood samples to study genetic and other aspects of the disease.~      Objectives:~      - To collect skin and blood samples to study genetic and other aspects of podoconiosis.~      Eligibility:~        -  Individuals at least 18 years of age who have podoconiosis (early stage or advanced~          stage).~        -  Healthy volunteers at least 18 years of age.~        -  Participants will be recruited from a study clinic and hospital in Ethiopia.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Blood samples will be collected. A skin biopsy will be performed to collect tissue for~          study. People who have podoconiosis will provide affected and unaffected tissue.~          Healthy volunteers will provide a single skin biopsy sample.~        -  Treatment will not be provided as part of this study.~   "
85414|NCT01939418|"~     This study consists of two parts. In a phase Ib part, investigators will explore the~     recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with~     metastatic TNBC. After completing the phase Ib part, investigators will review the data and~     discuss with Novartis before the start of a phase II part. In the phase II part,~     investigators will compare the efficacy of the gemcitabine and cisplatin with or without~     RAD001 in patients with metastatic TNBC.~   "
85415|NCT01939405|"~     The study aims are to develop and test the feasibility of a pediatric physical activity~     intervention that incorporates personal information on use of the built environment, and~     test the intervention's preliminary efficacy at increasing physical activity. The~     investigators hypothesize that it will be feasible to incorporate and measure changes in~     empiric GIS (geographic information system), GPS (global positioning system), and~     accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and~     accelerometer data collection (primary measure of feasibility), ii) Participation rates~     among adolescents in the intervention group compared to the control group, and iii)~     Acceptability to patients as measured by adolescent satisfaction.~   "
85416|NCT01939392|"~     This is a global, multi-center, prospective, randomized, controlled study of the safety and~     effectiveness of renal denervation with the OneShot Renal Denervation System in patients~     with uncontrolled hypertension.~   "
85417|NCT01939379|"~     The purpose of this study is that an adductor canal nerve block (putting numbing medicine~     near the nerve) has been shown to produce excellent pain relief with less pain medication~     use after knee replacement surgery.The investigators will be comparing the amount of pain~     relief following knee replacement surgery when you have a nerve block in place. There will~     be approximately 66 subjects participating in this study. After surgery subjects will~     receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine~     PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours~     around the clock with the option to receive more pain medication if needed. Subjects will~     participate in the study up to 3 days.~   "
85418|NCT01939366|"~     The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in~     patients when compared to placebo (a tablet that does not contain active product) and when~     compared to a marketed product containing pregabalin (Lyrica®, indicated for your pain~     condition). Furthermore, this trial will be undertaken to find out if the patient's general~     health and well-being improves under trial treatment.~      The concentrations of cebranopadol in the blood will be investigated to get a better~     understanding of how it is absorbed from the gut, distributed and broken down in the body,~     and eliminated from the body.~   "
85419|NCT01939353|"~     This is a Phase 2 exploratory study being conducted to evaluate the efficacy and safety of~     EB-1020 SR in treating adult male patients who meet DSM-IV-TR diagnostic criteria for ADHD~     on the M.I.N.I.-Plus. Evaluations include determining an effectiveness signal for ADHD and~     related symptoms and exploring dosing, tolerability, onset of action, and duration of~     effect. Dose-response/tolerability relationships with EB-1020 SR will also be explored. The~     1-week placebo lead-in also will be used for informal safety comparison purposes.~   "
85420|NCT01939340|"~     Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing~     chemotherapy. The purpose of this study is to assess prevalence of cachexia and low~     nutritional intake and the impact on quality of life, fatigue and mortality in patients~     undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease~     and chemotherapy, respectively.~   "
85421|NCT01939327|"~     The incidence of non-Hodgkin's lymphoma (NHL) is steadily increasing worldwide. At present,~     it is the sixth most commonly diagnosed cancer in France, with 10 000 estimated new cases~     and 5200 deaths annually. An increasing NHL incidence at a rate of 3-4% per year was~     observed for the 1970s and 1980s. This stabilized in the 1990s, nevertheless still with an~     annual rise of 1-2%, resulting in almost a doubling of the NHL incidence during last 40~     years. This rise has been noted worldwide, particularly in elderly persons >55 years.~     Increases in high-grade NHL and extranodal disease are predominant. There is about 80% of~     B-cell histology, approximately 90% of follicular lymphomas and about 70% of aggressive~     lymphoma patients present with disseminated disease at diagnosis. The prognosis of NHL~     depends on the histological type, stage and treatment. Indolent lymphomas have a relatively~     good prognosis with survival time as long as 10 years, but they are usually incurable in~     advanced stages. Aggressive NHL constitutes about 50% of all cases of NHL in Western Europe.~     Approximately 50 - 60% of these patients can be cured with immuno-chemotherapy regiments.~     Subsequently, almost 50% of patients will eventually relapse or become refractory to~     treatment. The prognosis for patients with refractory or relapsed aggressive NHL is~     generally poor. The response rates to salvage therapy regimens range from 20 to 40%.~     Patients who present with refractory disease have the worst prognosis, with a median~     survival of less than six months. Only a minority of patients can be given high dose~     chemotherapy, the majority being ineligible due to disease progression.~      By modulating the immune system through dendritic cells and NK cells, by changing the~     cytokine milieu, and by their anti-angiogenic effects, IMiDs in combination with mabthera~     (rituximab) resulted in augmented in vitro and vivo antitumor effects against B-cell~     lymphoma.~      As concerns the timing of administration and doses of medications, phase I/II studies are~     ongoing with R-CHOP in combination with Revlimid (Lenalidomide) in DLBCL. The latest~     presentation is by Nowakowski et al. at ASCO meeting in June 2010. This study determined the~     maximum tolerated dose of Revlimid(Lenalidomide)administered on days 1-10 with standard~     R-CHOP (R2-CHOP). NO DLT was found and 25 mg of Revlimid(Lenalidomide)was the recommended~     dose for phase II with enrollment of 32 patients. These encouraging results permit to~     introduce in our much less toxic protocol 25 mg of Revlimid(Lenalidomide)as initial dose,~     with progressive reduction in case of toxicity.~      As regards the dose and timing of Mabthera(Rituximab), in DLBCL it was traditionally used as~     a single 375 mg/m2 injection/cycle. Pre-clinical data suggests that for the optimal NK~     enhancement Revlimid(Lenalidomide)must be administrated several days (approx. 7 days) before~     Mabthera(Rituximab)injection. So, our protocol provides Mabthera(Rituximab)IV administration~     at day 7 of Revlimid(Lenalidomide).~      Performed parallel biological investigation of NK status will permit to confirm this~     hypothesis with possible correction of timing and number of administrations of~     Mabthera(Rituximab)par cycle.~   "
85422|NCT01939314|"~     The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve~     block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to~     assess the duration of the analgesia.~   "
85423|NCT01939301|"~     This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism~     with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to~     receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a~     submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction.~     Investigators hypothesize that the administration of inhaled NO + oxygen to patients with~     severe submassive PE will improve RV function, reduce RV strain and necrosis and improve~     dyspnea (difficulty breathing) more than sham oxygen treatment.~   "
85424|NCT01939288|"~     What is known?~        -  Disorders of peripheral circulation result in vascular morbidity and mortality~        -  Augmentation of peripheral circulation has been shown to be of benefit in both venous~          and arterial disease~        -  The benefit of intermittent pneumatic compression is clinically well evidenced.~        -  The use of intermittent pneumatic compression is limited by compliance issues related~          to sleeve application and external power source.~      What new information will this trial contribute?~      - This evaluates the haemodynamic effect of a new electrical device for augmentation of~     peripheral circulation~   "
85610|NCT01936012|"~     The present study was conducted to find out whether the bioavailability of 10 mg lisinopril~     tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator~     (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra~     Zeneca UK Ltd.)~   "
85426|NCT01939262|"~     Patients will be randomized into the control or intervention group. Based on patient~     preference, the intervention group will be trained for one hour in either individual or~     group format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com~     for low glycemic, animal free, low fat food options and support. The control group will~     continue their normal omnivorous diet program. Twenty-four hour food recalls will be~     obtained at the start and end of the trial, and once a week for the 6 weeks of the trial by~     telephone. Patients will undergo a final interview at the end of the 6 week study period.~     The intervention group should strive to obtain 90% of their calories from plants. They will~     be encouraged to eat freely and not count calories. Patients will undergo additional~     individual consultation as needed to promote compliance and answer specific questions.~      Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form~     health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual~     Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein~     levels will be assessed at the beginning and end of the study at Munson Medical Center~     Laboratories as a secondary measure of diet changes.~      There have been no published prospective randomized controlled trials assessing whether a~     vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a~     vegan diet will result in subjective reduction in perceived pain and limitations to function~     in patients with osteoarthritis.~   "
85427|NCT01939249|"~     BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The~     purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the~     Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary~     lesions. The study is powered for non-inferiority with respect to Target Vessel~     Failure(TVF)at 12 months.~   "
85428|NCT01939236|"~     The purpose of this study is to determine whether traditional Chinese medicine as~     complementary treatment is safe and effective in the treatment of chronic heart failure.~   "
85429|NCT01939223|"~     To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects~     with colorectal cancer (CRC) after curative resection of liver metastasis and completion of~     all planned chemotherapy.~   "
85430|NCT01939210|"~     This randomized pilot clinical trial studies the effects of meditation-based breathing~     training on patients' control of their breathing patterns and breathing-related movement, as~     well as on their psychological distress and treatment experience during radiation therapy.~     Meditation-based breathing training may decrease breathing-related movement and the amount~     of stress by improving breathing patterns in patients with abdominal or lung cancer~     undergoing radiation therapy.~   "
85431|NCT01939197|"~     The purpose of this study is to assess the safety and efficacy of~     ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without~     ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus~     Infection with Human Immunodeficiency Virus, Type 1 coinfection.~   "
85432|NCT01939184|"~     The purpose of this study is to evaluate the safety and efficacy of various fixed daily~     doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to~     BPH.~   "
85433|NCT01939171|"~     To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To~     demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by~     decreasing expression of inflammatory markers in graft biopsies Security:To demonstrate that~     the administration of Thymoglobulin does not have side effects in renal recipients.~   "
85434|NCT01939158|"~     The purpose of this study is to compare the immediate and long term (up to 5 years)~     immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose~     or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if~     co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar~     13 adversely impacts the immunogenicity of either of the vaccines.~   "
85435|NCT01939145|"~     This is a prospective, randomized trial comparing the outcomes for Prontosan versus normal~     saline as the solution for negative pressure wound therapy with instillation (NWPTi).~     Negative pressure wound therapy (NPWT) is a well established method of treatment for acute~     and chronic wounds. The combination of negative pressure with instillation of a solution is~     a relatively novel concept that has gained popularity and is currently used nationally and~     internationally. NPWTi is the standard of care for our division. Despite the growing use,~     there is limited information regarding the selection of the ideal instillation solution.~     This is a single site, investigator initiated, NPWTi study comparing the use of Prontosan~     with normal saline for the adjunctive treatment of the acutely infected wound that requires~     hospital admission. A total of 100 subjects will be included with 50 subjects in each~     treatment arm. The outcomes that will be measured are 1) number of operations, 2) length of~     hospital stay, 3) % of wounds closed prior to discharge, 4) time to closure prior to~     discharge, 5)% remained closed at 30 day follow-up, and 6) reduction of qualitative~     bacterial cultures. The results from this study will better characterize the most~     appropriate use of NPWTi.~   "
85436|NCT01939132|"~     Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints,~     tendon sheaths, entheses, and the axial skeleton as well as skin and nails. This is an~     open-label trial with H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered~     twice weekly. To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks,~     including American College of Rheumatology 20,Clinical Disease Activity Index, Disease~     Activity Index 28, Dactylitis and adverse events.~   "
85437|NCT01939119|"~     The purpose of this study is to examine the body-fluid balance in patients with retinal~     vascular occlusion and the influence of drinking habits and hemodilution on the degree of~     body hydration.~   "
85438|NCT01939106|"~     To assess the safety and performance of an enhanced one piece drainable pouch in subjects~     with an ileostomy.~   "
85439|NCT01939093|"~     The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an~     atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic~     disorder, in individuals with MAP.~   "
85482|NCT01938521|"~     The aim of this study is to examine whether the chronic administration during 12 weeks of~     polyphenols contained in Red Grape Cells (RGC) powder has an effect on mRNA expression of~     SIRT1 and Clock Genes, on circulating levels of HbA1c, lipids, blood pressure and on~     postprandial response of glucose, lipids, insulin, C-peptide and GLP-1 in patients with type~     2 diabetes .~   "
85440|NCT01939080|"~     Many conditions and cardiovascular diseases (including stroke) are better managed with~     regular exercise training. The expected effects are partial reversal of adverse effects on~     heart and blood vessel structure and function, improved glycemic, tension and weight~     control.~      Physiologically, the aorta maintains low left ventricular after-load, promotes optimal~     sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow.~     Increased aortic stiffness may ultimately contribute to left ventricular dysfunction.~     Regular exercise training is likely to decrease the pulse wave velocity (a measure of the~     aortic compliance). Some subjects seem more responsive than others, and they may not expect~     the same benefit of exercise training. To the best of our knowledge, this has not been~     explained yet.~   "
85441|NCT01939067|"~     This study is designed to evaluate the effect of heated humidified high flow nasal cannula~     (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on~     lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks~     gestation requiring continuing respiratory support.~   "
85442|NCT01939054|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting~     tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase~     Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine（TX）versus Docetaxel and~     Capecitabine（TX）as first-line treatment in patients with recurrent/metastatic triple~     negative breast cancer.~   "
85443|NCT01939041|"~     Robot-assisted training (RT) devices developed to date have a significant impact on stroke~     rehabilitation. Several research groups have developed the robotic devices and examined~     their efficacy on improving UL function after stroke. All these robotic devices have been~     applied in stroke rehabilitation and their efficacy are evaluated, but the scientific~     evidence for the mechanisms of RT-induced recovery, the relative treatment effects of~     unilateral vs bilateral robotic trainings, and the impact on physiological responses is~     still lacking.~      The primary purposes of this study are to examine (1) the relative immediate treatment~     effects of unilateral vs bilateral RT on motor impairments/performance and daily functions~     in patients with subacute stroke; (2) the long-term benefits of unilateral vs bilateral RT~     by conducting a 6-month follow up evaluation; and (3) the effects of RT on movement~     reorganization as well as on the physiological markers of inflammation, oxidative stress,~     erythrocyte deformability, and blood glucose. These overall findings will help better~     understanding of the efficacy of RT on functional outcomes, movement reorganization, and~     physiological markers. The investigators would additionally explore the possible~     differential treatment effects in patients with different levels of motor severity (i.e.,~     moderate vs. severe).~      The investigators hypothesize that (1) both unilateral (the InMotion3) and bilateral (the~     Bi-Manu-Track) robot-assisted training would bring larger benefits on motor performance and~     daily function than the control treatment; (2) such benefits would retain during the~     follow-up; (3) there would be differential immediate and retention effects of unilateral~     (the InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training on different~     outcome measures; (4) better movement reorganization as well as physiological marker~     expressions would be found in both robotic groups compared to control group; and (5) there~     would be differential effects of robotic therapy between participants with moderate vs.~     severe motor impairment.~   "
85444|NCT01939028|"~     This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial~     cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove~     endometrial cancer and affected lymph nodes.~   "
85445|NCT01939015|"~     -  The aim of this study is to compare the standard and 3D miniplates fixation in~          mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain,~          hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one~          method over the other.~        -  Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will~          used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients~          returned 7 days after surgery for clinical evaluation . The patients will be examined~          radiographically for accuracy of the reduction, screw positioning, adverse reactions in~          the vicinity of screw placement, and bone healing. the complications encountered will~          be recorded and treated. The clinical evaluations will be performed by 1 surgeon at~          each institution.~        -  The patients will also evaluated clinically for infection, nonunion, pain,~          hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints.~          Criteria for infection will based on either of the following conditions: 1) purulent~          discharge from an incision and 2) serosanguineous drainage and a wound culture positive~          for a known pathogen. All the patients will evaluated postoperatively by a single~          assessor.~        -  Statically analysis :~      Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤~     0.05 will be considered statistically significant.~   "
85446|NCT01939002|"~     The primary objective of this study is to determine the proportion of participants with~     relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS)~     after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).~      Secondary objectives are: to determine the severity and frequency (measured by flu-like~     symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in~     number of hours) of FLS in these participants; to determine the effect of BIIB017 on other~     participant-reported outcomes, including treatment satisfaction (measured with the Treatment~     Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the~     Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether~     interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism);~     to assess the use of additional medications (in addition to current medications used to~     treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events~     throughout the study period; to characterize the immunogenicity profiles of participants~     switching from prior IFN-β therapy to BIIB017.~   "
85447|NCT01938989|"~     The purpose of this study is to evaluate photostress recovery with blue light filter clip-on~     glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been~     replaced with an artificial lens (intraocular lens) during cataract surgery]. This study~     will enroll subjects previously implanted with no blue light filter intraocular lenses~     (IOLs) for at least 3 months.~   "
85448|NCT01938976|"~     Study Hypotheses:~        1. adolescents in intervention schools who are given Triple A program plus ASP will show~          more awareness in regards to cigarettee smoking health effects and less nicotine~          dependencethan those in the control schools who are given Triple A alone.~        2. adolescents with asthma in intervention schools who are given Triple A program plus ASP~          will show less asthma symptoms and better control than those in the control schools who~          are given Triple A alone.~        3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide~          (CO) in their breath than those who are not active or passive smokers.~        4. there is a positive correlation between self-report questions regarding student smoking~          status and levels of CO in their breath~   "
85611|NCT01935999|"~     A study to assess the safety and performance of an enhanced one piece closed pouch in a 12~     subjects with a colostomy.~   "
85450|NCT01938950|"~     The current epidemic rate of childhood obesity is a leading health concern as~     overweight/obese youth may suffer from comorbid conditions, once considered exclusive to~     adults. It has been suggested that physical inactivity is a major determinant of obesity and~     obesity-related health risk in children and adolescents. Recent studies in adults report~     that the combination of aerobic and resistance exercise is a better strategy than aerobic or~     resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most~     effective exercise modality for concurrent reductions of adiposity, in particular abdominal~     fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in~     adolescents. Therefore, we will employ a randomized trial to examine the effects of a~     long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens~     on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total~     adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and~     skeletal muscle, and 3) traditional and non-traditional risk factors/markers for CVD in~     overweight boys and girls. We will recruit 168 sedentary overweight (BMI >85th percentile)~     adolescent boys and girls aged 12-17 years old and randomly assign them to one of three~     6-month intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2)~     resistance exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week)~     group. A weight maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will~     be prescribed and monitored for all groups, so that any changes in energy balance will be~     induced by exercise intervention alone (e.g., no calorie restriction). We believe that this~     proposed application will have a significant implication that is directly relevant for one~     in three American adolescents who are at increased risk of developing obesity-related~     co-morbidities.~   "
85451|NCT01938937|"~     The purpose of this study is to determine if transcranially administered bright light has~     acute effect on anxiety symptoms.~   "
85452|NCT01938924|"~     A study to investigate if the gekoTM device improves flow through vascular bypass grafts~   "
85453|NCT01938911|"~     To test a psychopharmacological intervention strategy which may provide new insights into~     the mechanisms underlying the physiological hyperreactivity to stress observed in~     hypertension, we plan to test the effects of the neuropeptide oxytocin and social support on~     the neurobiological and psychological responsiveness to social stress. The study population~     for this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free~     men. We expect exogenous oxytocin administration to enable hypertensives to effectively take~     advantage of the provided social support. Thereby, oxytocin may enhance the effect of social~     support on reducing the previously observed physiological hyperreactivity to stress in~     essential hypertensives.~   "
85454|NCT01938898|"~     The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) is an opportunity~     to conduct methodology research relevant to many features of a large prospective study.~     NICOLA will begin in earnest in Northern Ireland in 2013 and is being conducted by a~     multidisciplinary team in the Centre for Public Health at Queen's University Belfast. It is~     an omnibus programme of research on ageing that will continue for at least 10 years and will~     recruit 8500 middle-aged people in Northern Ireland and follow them into old age, providing~     a comprehensive assessment of their physical and mental health, their lifestyles, and their~     social and economic decision making. NICOLA will look at how they perceive disability and~     health, and how this differs between well-off and disadvantaged groups. NICOLA will also~     study various genetic, biological and psychological factors, including how participants~     perceive risk and value their time, and the effect of this on their retirement behaviour~     (including how they manage their money and their health). People over the age of 50 will be~     invited to take part and asked to complete detailed interviews and questionnaires every 2~     years and health assessments every 4 years.~      The overall aim of this research is to examine the impact of differing invitation letters~     offered to participants on study recruitment rates.~   "
85455|NCT01938885|"~     Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is~     potentially fatal, as it can lead to sudden severe haemorrhage. The risk of developing~     posttraumatic hepatic pseudoaneurysm is one of the reasons why some trauma centres do~     follow-up CT of patients with liver injuries to take the therapeutic consequence. The aim of~     this study was to investigate the occurrence of HPA post liver trauma.~   "
85456|NCT01938872|"~     to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee~     angioplasty in terms of restenosis at 12 months~   "
85457|NCT01938859|"~     The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles~     between different mood stabilizers combination treatments in the patients with bipolar~     disorders, currently suffered from depression episode.~   "
85458|NCT01938846|"~     The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI~     860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs,~     patients are entered sequentially into escalating dose cohorts. Secondary objectives are~     objective response and disease control according to RECIST criteria version 1.1~   "
85459|NCT01938833|"~     This phase I/II trial studies the side effects and best dose of romidepsin when given~     together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well~     they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving romidepsin and paclitaxel albumin-stabilized~     nanoparticle formulation may be an effective treatment for inflammatory breast cancer.~   "
85460|NCT01938820|"~     Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to~     metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for~     2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year,~     entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every~     six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate~     regression rate of liver fibrosis 1.5 years after initial therapy.~   "
85468|NCT01938716|"~     The goal of this clinical research study is to learn if gemcitabine given during surgery can~     enter pancreas cancer cells in patients who have already received chemotherapy and~     radiation.~      Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been~     studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block~     the growth of cancer cells, which may cause cancer cells to die.~   "
85535|NCT01937819|"~     High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated~     visual aids as a means of improving the quality of bowel preparation. We assess the effect~     of patient-judging dose adjustment of bowel preparation solution for bowel preparation using~     SMARTPHONE application on the quality of bowel preparation.~   "
85461|NCT01938807|"~     Despite multidisciplinary care and advancements in therapeutics and technology, health~     outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to~     poor outcomes is suboptimal diabetes management in pediatric patients and their families.~     The premise of this research project is that patients and families do not have adequate~     resources to meet the level of diabetes management that translates to better outcomes.~     Therefore, we will give them a valuable tool to improve their overall management. The tool~     is CareCoach.~      Research shows that enhancing communication and partnership among patients, parents, and~     providers is especially critical for optimal outcomes in pediatric diabetes. Communication~     gaps and conflict can complicate the already complex provider-patient interactions and daily~     management. We have therefore designed, refined, and made available to consumers a new~     mobile-based intervention, CareCoach, to improve communication; build trust among providers,~     patients and parents; and increase overall satisfaction with the quality of diabetes care.~     This web/mobile application is designed to help patients unobtrusively audiorecord their~     clinical encounters, track their medical consults and treatment plans, review information~     from past visits, create visit discussion guides, and track adherence to medication and~     dosing schedules. In addition, because mobile-based applications are inexpensive to~     administer, portable, and available at all times of day, CareCoach holds great promise for~     communication coaching and contributing to improved diabetes management.~      We hypothesize that CareCoach will improve patient-parent-provider communications, build~     patient-parent-provider trust, and increase overall satisfaction with clinical interactions~     in a sample of children with type 1 diabetes and their parents. These improvements will lead~     to significant gains in diabetes management, setting the stage for optimal health outcomes.~     To test the effectiveness of CareCoach, we will conduct a randomized controlled trial~     comparing the CareCoach intervention to standard care in a sample of 60 children with type 1~     diabetes and their parents.~   "
85462|NCT01938794|"~     Accurately measuring how many calories a person burns each day is difficult to do.~     Researchers can do this with a technique called doubly labeled water (DLW). This involves~     drinking water that is labeled with a non-radioactive tracer. After a few hours, the~     labeled water can be detected in the urine. To measure how many calories are burned (Total~     daily energy expenditure, TDEE), urine samples are collected several days apart. Although~     this technique is accurate, it is also challenging for two reasons. First, the labeled water~     is expensive. Second, the urine samples are analyzed using equipment (Isotope Ratio Mass~     Spectrometer, or IRMS) that is expensive and difficult to operate. The goal of this project~     is to develop a new instrument to perform DLW measurements of TDEE. This instrument, called~     a triple isotope water analyzer (TIWA) is less expensive and easier to operate than IRMS.~     Additionally, since the TIWA is more accurate than IRMS, it may potentially reduce the~     amount of labeled water required to measure TDEE, and thus reduce costs. The purpose of this~     study is to compare the accuracy of measuring TDEE from labeled water using the new~     instrument (TIWA) and from the traditional approach (IRMS). We will also compare the~     accuracy to the measurement of TDEE from whole-room indirect calorimetry (metabolic room),~     which is considered the most accurate way to measure TDEE.~   "
85463|NCT01938781|"~     Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar~     to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir~     alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus~     pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year.~     Patients will be assessed at baseline, at every six months for blood count, liver function~     test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan.~     The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5~     years after initial therapy.~   "
85464|NCT01938768|"~     Severe external and internal bleedings are common in multiple trauma patients.~     Uncontrollable blood loss is the cause for about one third of all trauma deaths. A number of~     blood clotting mechanisms are known to be triggered by major blood losses. These mechanisms~     shall secure the organisms from loosing even more blood. To avoid an overshooting clotting~     behavior, inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic)~     mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. In~     severe bleeding situations this mechanism tends to overshoot and therewith contributes to~     the severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in~     approximately one third of all multiple trauma patients. Mortality rates are increased in~     these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion~     from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A~     large study showed positive influence of tranexamic acid on mortality rates and blood loss~     in severely injured patients, when it was administered in an early clinical setting. In this~     study we want to answer the question wether a hyperfibrinolysis can be seen in an early~     prehospital (on the scene) setting and how it is influenced by an early prehospital~     administration of tranexamic acid.~   "
85465|NCT01938755|"~     Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of~     regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space,~     generally through a fine needle.~      There is no generic hyperbaric form of levobupivacaine currently available so we aimed in~     this study that to find the appropriate concentration of the levobupivacaine which achieves~     unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less~     motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be~     suitable for outpatient anesthesia.~   "
85466|NCT01938742|"~     This is a Phase II randomized, double-blinded, controlled study in up to 700 males and~     non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety,~     reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine~     administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and~     without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75~     mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days~     apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time~     points with safety follow-up to continue through one year post dose 2. The duration of the~     study for each subject will be approximately 13 months.~   "
85467|NCT01938729|"~     This is a Phase I study, which means we want to find out what effects, good and/or bad, this~     combination of drugs may have on the patient and the liver cancer at different dose levels.~     All patients will have an operation to remove tumors in the liver and may have a pump placed~     in their abdomen.~      On this study, both drugs given have been used in other patients for treatment of~     cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food~     and drug administration (FDA) for treatment of liver cancer, but the two drugs have only~     been combined in a few patients.~      That means that in this trial we also want to find out if this combination is safe.~      The study will also evaluate if this treatment works in delaying or stopping the cancer from~     coming back after surgery.~   "
85612|NCT01935986|"~     The purpose of this study is to study the effect of a probiotic on protection against upper~     respiratory tract infections (URTI) in children.~   "
85469|NCT01938690|"~     Approximately two thirds of stroke survivors have profoundly impaired function of the upper~     limb. Currently the main stay of the treatment for upper limb motor function is~     rehabilitation therapy focusing on repetitive and skillful task practice (task-oriented~     therapy) which has been shown to induce substantial functional reorganization in the~     undamaged motor cortex and functional recovery. In spite of rehabilitation therapy,~     functional recovery of arm and hand function is limited to one third of stroke survivors and~     there is a great need for adjunct treatment to current practice. Repetitive Transcranial~     Magnetic Stimulation (rTMS) is a noninvasive means of stimulating nerve cells in superficial~     areas of the brain and emerging as a novel method of modulating cortical excitability and~     promoting functional recovery after stroke. There have been studies using rTMS to improve~     motor function after stroke. However, whether 1Hz rTMS can enhance the effect of the~     task-oriented therapy on upper limb function after stroke has not been investigated. In this~     pilot proposal, we intend to investigate the feasibility of 1Hz rTMS on unaffected~     hemisphere as an adjunct to task-oriented therapy to improve upper limb motor function among~     stroke patients. The information obtained from this pilot study will provide a platform for~     the future randomized control trials combining the rTMS and task-oriented therapy to enhance~     motor recovery among stroke survivors.~   "
85470|NCT01938677|"~     The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular~     schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the~     hearing is preserved in most patient years after the gamma knife treatment. Recent~     prospective data suggests that radiosurgery could be a hearing preserving treatment for~     these patients.~      The main objective of this study is to evaluate if GKRS can inhibit progression of hearing~     loss in patients with VS. Patients with preserved hearing will be offered to participate in~     the study and randomized ether to GKRS or initial conservative treatment for their~     vestibular schwannoma. They will then be followed with scheduled magnetic resonance~     image(MRI) and audiometry and evaluated after one, three and five years after treatment.~   "
85471|NCT01938664|"~     The purpose of this study is to see if a drug called Candesartan will help to reduce use of~     cocaine.~   "
85472|NCT01938651|"~     This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and~     magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic~     procedures may be a more sensitive way to detect breast cancer.~   "
85473|NCT01938638|"~     The purpose of this study Part A is to determine the safety, tolerability and the~     pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either~     refractory to or ineligible for treatment with standard agents.~      The purpose of this study Part B is:~      Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose~     (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte~     colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in~     subjects with advanced malignancies.~   "
85474|NCT01938625|"~     The purpose of the study is to evaluate effect of steady-state (when the amount of drug~     administered (in a given time period is equal to the amount of drug eliminated in that same~     period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a~     medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when~     administered as a combinational regimen in post-orthotopic liver transplantation (OLT)~     participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness~     of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with~     respect to the proportion of HCV genotype 1b infected post-OLT participants achieving~     sustained virologic response 12 weeks after end of treatment.~   "
85475|NCT01938612|"~     This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with~     a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics~     in patients with advanced solid tumor followed by an expansion phase in patients with~     advanced solid tumors.~   "
85476|NCT01938599|"~     To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment~     of plaque psoriasis.~   "
85477|NCT01938586|"~     The purpose of this study is to compare the cosmetic outcome between buried intradermal and~     superficial cutaneous suture closures versus buried intradermal sutureand superficial~     Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following~     elliptical excision of benign or malignant lesions~   "
85478|NCT01938573|"~     This phase I/II trial studies the side effects and best dose of sirolimus when given~     together with cisplatin and gemcitabine hydrochloride and to see how well they work in~     treating patients with bladder cancer. Biological therapies, such as sirolimus, may~     stimulate or suppress the immune system in different ways and stop tumor cells from growing.~     Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving sirolimus together with~     cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.~   "
85479|NCT01938560|"~     As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and~     pharmacists' understanding of the risk of urinary retention with retigabine products. This~     is to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as~     outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey~     are to assess prescribers' and pharmacists' understanding of the risk of urinary retention~     and the symptoms of acute urinary retention potentially associated with retigabine use as~     evaluated by a survey instrument.~      This is a cross-sectional study of approximately 200 physicians (e.g.~     neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in~     the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at~     least once in the last 3 months. The primary outcome of the survey is the proportion of~     physicians and pharmacists providing correct responses to a series of questions concerning~     the risk of urinary retention and the symptoms of acute urinary retention that may be~     associated with retigabine. The risks captured will be those described in the retigabine~     Dear Healthcare Provider (DHCP) letters, specifically risks of urinary retention.~   "
85480|NCT01938547|"~     To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine~     for blood pressure (BP) management in pediatric patients in the perioperative setting.~   "
85481|NCT01938534|"~     Prospective study : Helicobacter pylori eradication therapy in accordance with past~     antibiotics use.~   "
85483|NCT01938508|"~     This study compared the bioavailability of two formulations 100 mg (one capsule or other~     respectively) of each one of the products, of Minocycline, under fasting conditions, in~     healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours~     prior to study) conditions, cross, with two treatments, two periods, two sequences (2x2)~     randomized sequence, balanced, and with a washout period of at least 7 days between each~     dose, in 24 healthy volunteers.~   "
85484|NCT01938495|"~     The study is being conducted to determine if DPS treatment for people with ALS and~     hypoventilation is associated with improved survival or diaphragm function.~      The primary objective of the study is to conduct a multi-center, randomized controlled~     clinical trial comparing standard of care (control) to diaphragm stimulator treatment with~     the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.~      The secondary objective of the study is to conduct a multi-center, randomized controlled~     clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with~     hypoventilation.~   "
85485|NCT01938482|"~     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan~     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and~     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),~     after topical administration on healthy subjects and acne patients. Study SCD117226 will be~     a randomized, single-blind, dose-rising study to evaluate the safety, tolerability and~     preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029~     gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will~     receive 0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour~     (h) (22.5h) application to a surface area of 400 square centimeter (cm^2) (0.3%), 400 cm^2~     (1%) or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Part 2:~     (repeat-dose) subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily~     App24h (22.5h) application to a surface area of 400 cm^2 (0.3%), 400 cm^2 (1%) or 1200 cm^2~     (1%), respectively, in each of three sequential cohorts. Parts within Study SCD117225 and~     Study SCD117226 will have interdependencies. No significant primary irritation signal in~     Study SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part~     1. Once safety, tolerability and exposure information are determined in Study SCD117226 Part~     1, then Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2~     of Study SCD117226. No significant cumulative irritation signal (study SCD117225 Part 2) in~     combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of~     Part 3 (facial irritation) of Study SCD117225.~   "
85486|NCT01938469|"~     Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut~     peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric~     bypass surgery (GBP).~   "
85487|NCT01938456|"~     The primary purpose of this study is to evaluate the safety and tolerability of the~     combination therapy of trametinib and docetaxel with growth factor support in Japanese~     subjects with Stage IV or a postoperative recurrence non-small cell lung cancer (NSCLC).~     This study data will be used for making decision for further Japanese development plan for~     NSCLC. Six evaluable subjects will be enrolled in a dose level to evaluate the safety and~     tolerability of the combination treatment. Dose-limiting toxicity will be assessed during~     the first 21 days of combination therapy.~   "
85488|NCT01938443|"~     The purpose of this study is to assess the safety of combination treatment of GSK2256098 and~     trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the~     study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This~     study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose~     (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib~     (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing).~     The synergy of the combination was observed over a wide range of concentrations and results~     in several-fold reduction in compound concentration to achieve equivalent biological~     responses compared to either single agent. The dose and schedule of dosing may be modified~     based on emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study~     will be conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and~     Part 2 Expansion Cohort to further evaluate the safety and tolerability of trametinib and~     GSK2256098 at the RP2D and determine clinical activity. Additionally, in Part 1 Dose~     Escalation, additional subjects with malignant pleural mesothelioma (MPM) will be recruited~     at doses that are considered tolerable in order to assess PD in MPM subjects at each dose~     (the Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who~     have progressed or are intolerant to first-line therapy.~   "
85489|NCT01938430|"~     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus~     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic~     genotype 1 or 4 hepatitis C virus (HCV) infection.~        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;~        -  Cohort B: post-liver transplant, with or without cirrhosis;~        -  Group assignment within cohorts is based on severity of liver impairment at screening~          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence~          of disease for fibrosing cholestatic hepatitis (FCH) groups)~        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.~   "
85490|NCT01938417|"~     This study aimed to assess the systemic absorption and disposition of tobramycin in patients~     treated with a tobramycin-laden bone graft substitute (Osteoset® T).~   "
85491|NCT01938404|"~     To assess and evaluate the safety of octaplas™ in comparison to standard plasma product~     (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of~     thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange,~     with a special emphasis on the occurrence of thromboembolic events (TEEs).~   "
85492|NCT01938391|"~     IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy~     System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have~     symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery~     (SFA), Popliteal (POP),and/or Tibioperoneal Trunk (TPT).~   "
85493|NCT01938378|"~     To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring~     serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),~     thromboembolic events (TEEs) and by measuring safety laboratory parameters.~   "
85494|NCT01938365|"~     primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and~     youth.~      secondary outcomes:~        1. To classify diabetes by gene detection in Chinese adolescent and youth.~        2. To make the relationship between genotype and clinic phenotype in type 1 diabetes.~        3. To evaluate the effect of environmental factors (intestinal ecosystem)in the~          pathogenesis of diabetes.~   "
85495|NCT01938352|"~     After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be~     challenged with the H3N2 virus. The protective efficacy, safety, tolerability,~     pharmacokinetics, and potential immunogenicity will be assessed.~   "
85496|NCT01938339|"~     To development of clinical assessment technique using multi-radiotracer positron emission~     tomography/magnetic resonance (PET/MR) in prostate cancer~        -  to establish the optimal imaging technique of PET/MR using multiple radioactive tracers~          for prostate cancer~        -  to establish the imaging biomarker using PET/MR for clinical assessment of prostate~          cancer and early detection of recurrent prostate cancer~   "
85497|NCT01938326|"~     1. Compare the immune response and postoperative complications between pure SIDG~          (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal~          gastrectomy) for early gastric cancer (EGC)~        2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)~   "
85498|NCT01938313|"~     Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of~     reducing the surgical stress response and obtaining optimal recovery after surgery.~   "
85499|NCT01938300|"~     Magnesium sulphate is given to the patients during the colorectal cancer surgery under the~     hypothesis that it would attenuate the postoperative hypercoagulability. The investigators~     intend to characterize the changes of coagulation in colorectal cancer patients by using the~     point-of-care device after the infusion of magnesium sulphate.~   "
85500|NCT01938287|"~     This study investigates the effect of eye opening/closure on the quality of IOP (intraocular~     pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2~     24-hour recording sessions, one with the recorded eye open and the other with the eye~     closed,using an ophthalmic patch.~   "
85501|NCT01938274|"~     To pilot test an activity-focused intervention that educates patients undergoing total hip~     (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type,~     frequency, intensity, and duration of expected leisure activities after surgery and to~     determine if the intervention changed expectations.~   "
85502|NCT01938261|"~     Present randomized, controlled, double-blind trial investigates the efficacy and safety of~     early (<24 h) intravenous paracetamol therapy for both the early closure of the ductus and~     pain medication in very small premature infants. This phase 2 drug study focuses on the~     efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of~     paracetamol, as well as the long-term effects, are studied.~      This study recruits preterm infants born less than 32 weeks gestational age and treated at~     the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked~     from all parents. The first drug dose is given before 24 hours of age. Masked study drug is~     paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The~     loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The~     exact date of the closure of ductus is studied by repeated echocardiographic examinations.~     The symptoms of pain are screened by a locally used pain scale of preterm infants (NIAPAS).~     Patients are monitored for signs of possible side effects. After discharge from hospital,~     patients are examined at follow-up clinic for the first year every 3 months and at 2 years~     of age.~   "
85503|NCT01938248|"~     This study aims to determine if treatment with apixaban, compared with aspirin, will reduce~     the risk of ischemic stroke and systemic embolism in patients with device-detected~     sub-clinical atrial fibrillation and additional risk factors for stroke.~   "
85504|NCT01938235|"~     This study aims to assess the effect of exenatide on myocardial injury in patients~     undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation~     myocardial infarction or heart attack (STEMI).~   "
85505|NCT01938222|"~     A number of studies identifies abdominal hernia as the most frequent postoperative~     complication following laparotomy with percentages of 9-20% - depending on duration of~     follow-up. It is based on a multifactorial basis, including factors concerning individual,~     patient-specific factors, factors related to the operational technique as well as particular~     surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate~     (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being~     6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound~     complication rate of up to 50 % has to be expected. According to new, first findings from~     recent studies the rates of wound healing complication and burst abdomen can be reduced~     significantly. Depending on the study, to almost 50%. The principle is based on the~     reduction of the stitch length and type of the inserted suture. The stitches are closer and~     with less distance to the edge of fascia. Due to the much thinner suture it still comes here~     to a quantitative reduction of the inserted suture. The data collected using the MonoMax®~     suture in the short stitch technique will be compared to the results of the ISSAAC trial, in~     which the MonoMax® suture was used in the long stitch suture technique. The generated data~     are thus subject of retrospective comparison with a historical control group (ISSAAC study).~   "
85506|NCT01938209|"~     Thirty-nine patients with cervical spine pain were randomly assigned to either a seated~     thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range~     of motion measures were taken before and after the intervention.~   "
85507|NCT01938196|"~     The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose~     in chronic constipation patients.~   "
85508|NCT01938183|"~     Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers~     volunteers could improve clinical parameters when compared to metronidazole tablets +~     periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly~     assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal~     debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%);~     and periodontal debridement combined with a daily single dose of 750 mg metronidazole.~     Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth~     and relative attachment level.~   "
85509|NCT01938170|"~     This study will examine the feasibility of having parents and caregivers administer FluMist~     live intranasal vaccine to their children at home outside the traditional medical~     environment and without the involvement of medical personnel.~      The study will recruit patients and families that are already eligible to receive the~     FluMist vaccine. After consent is obtained and vaccine is given to the family, they will go~     home to administer vaccine to other members within 24 hours. Telephone follow up within 48~     hours will confirm that vaccine was given successfully and within 9-12 days to assess~     patient preferences for giving vaccine at home and if there were any adverse events.~   "
85510|NCT01938157|"~     Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with~     diffusion-weighted MR imaging can identify features more specific for breast cancer in women~     at high-risk of developing breast cancer.~      Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for~     a clinical breast MRI identified through the UNC Breast Clinic will be consecutively~     recruited for this study.~      Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a~     single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after~     the completion of patient accrual. The images will be analysed for lesions, enhancement~     patterns, diffusion weighted imaging data and correlated with any pathology or 1 year~     follow-up MRI exam. The study information will be entered into a secure database and~     analyzed.~   "
85511|NCT01938144|"~     This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group,~     comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/~     Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the~     relief of symptoms of the common cold and flu. The reference product that the active~     treatments will be compared to is paracetamol (PARA) 500 mg.~   "
85512|NCT01938131|"~     The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in~     elderly patients because they are long lasting and need the constant participation of~     patients. To rapidly improve the motor performances of patients it is possible to use the~     mechanical vibration applied to individual muscles using a protocol called repeated muscle~     vibration (rMV). The purpose of this single-blind randomized placebo-controlled study is to~     evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the~     ability of the patients affected by knee osteoarthritis, compared to an ineffective~     treatment, considered as a placebo. Each subject, randomly assigned to either the group 1~     (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of~     10 minutes each, for 3 consecutive days. Between two successive applications it's observed a~     break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed~     near the supero-medial margin of the patella, on both quadriceps. Patients in group 2~     (control group) are subjected to a treatment with muscle released in which the probe of the~     same instrument is approached to the quadriceps, without making contact. The instrument in~     these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the~     study is to determine the changing in patients' ability (as measured by WOMAC scale =~     Western Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of~     the study are the assessment of changing of patients' balance and risk of falling (as~     measured by the Tinetti scale) and assessment of changing of patients' quality of life (as~     measured by EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at~     baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3)~     after the end of treatment and 6 months (T4) after the end of the treatment.~   "
85513|NCT01938118|"~     The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic~     black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a~     multi-component home visitation program, compared to an attention control (child safety) in~     promoting appropriate weight gain during infancy.~   "
85514|NCT01938105|"~     The purpose of this study is to determine the feasibility and efficacy of preoperative~     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable,~     locally advanced cervical cancer.~   "
85515|NCT01938092|"~     To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain~     associated with pelvic floor hypertonic disorder.~   "
85516|NCT01938079|"~     In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide.~     However, in patients with severe lung failure, blood may not adequately be delivered to the~     lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may~     require assistance from a machine to help provide this oxygen. Extracorporeal membrane~     oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to~     recover from their illness. Patients receiving support from ECMO are often put in a~     medically induced coma while their lungs heal. Certain drugs may stick to the internal~     surfaces of the machine; therefore leading to decreased concentrations. Patients receiving~     ECMO often require high doses of both pain medications and sedatives in order to provide~     comfort. Low doses of a drug, ketamine, may help to provide additive effects to pain relief~     and allow lower doses of other pain medications. The hypothesis is that patients treated~     with continuous intravenous ketamine, will have lower requirements of other pain medications~     while receiving ECMO for acute respiratory failure while achieving the desired level of~     sedation.~   "
85517|NCT01938066|"~     The purpose of this study is to determine if Procellera speeds wound healing. The study will~     examine colonization (bacterial growth), pain and pain medication and reduced cost of care~     by using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the~     wound after abdominal wall surgery. Procellera is a single layer dressing that helps to kill~     germs that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that~     is placed in your wound to help heal the wound faster.~   "
85518|NCT01938053|"~     The primary goal of this project is to improve the process for contacting patients that test~     positive for a sexually transmitted infection (STI) in the emergency department by using~     text messaging. We believe patients that are contacted by both a phone call and a text~     message will be reached more often and they will be reached sooner than those that only~     receive a phone call or only a text message. In addition, patients will be given reminder~     cards at the time of testing to remind them that they will be contacted within 7 days if~     they test positive. Half of the reminder cards will have a number to call for test results.~     We believe patients that receive a card with a number are more likely to be contacted within~     7 days.~   "
85532|NCT01937858|"~     The value of HbA1c as a tool to determine glycemic control in patients with diabetes and~     renal failure has not been well studied, the same accepted normal ranges for HbA1c are~     applied to all patients with diabetes regardless of their renal function. We would like to~     evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup~     of patients with diabetes and evaluate the effect of dialysis on HbA1c~   "
85533|NCT01937845|"~     Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program.~     These outcomes include BMI, A1C, lipid profile.~   "
85519|NCT01938040|"~     This study is being done because the investigators wish to study ways to improve recovery~     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the~     body's attempt to protect itself and to start the healing process. Some surgical~     complications are related to the body's natural inflammatory response. Although mainly a~     healing response, inflammation can also have side effects which delay recovery. The~     investigators wish to determine the effect of a medication known as ibuprofen on recovery.~     You may know ibuprofen by the name Advil or Motrin. The medication will be given through the~     vein prior to the start of the surgery. Three blood samples will be taken, two while the~     patient is under anesthesia. The subject will be asked to complete several questionnaires.~   "
85520|NCT01938027|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision.~   "
85521|NCT01938014|"~     Hypothesis: Children diagnosed with a lysosomal disease will exhibit developmental,~     adaptive, and behavioral strengths and difficulties depending upon 1) biomedical risk~     factors (i.e. the specific genetic disorder responsible for the illness); 2) available~     modifying interventions, whether medical or behavioral; and 3) social risks in the~     children's families, neighborhoods and communities. A valid and reliable telephone-based~     surveillance system can successfully collect the data required to elucidate these~     developmental, adaptive and behavioral strengths and difficulties.~   "
85522|NCT01938001|"~     This double-blind randomized, parallel group study will evaluate the efficacy and safety of~     lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in~     patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients~     will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in~     combination with rituximab. Anticipated time on study treatment is 1 year.~   "
85523|NCT01937988|"~     This study will be a non-blinded randomized controlled trial (RCT) of women presenting for~     abortion at <13 6/7 weeks. Women will be randomized either to receive support by a trained~     abortion doula (intervention) or to have standard procedure (control) during the abortion~     procedure. The investigators hypothesize that women who receive doula support during a first~     trimester abortion will report less pain during the abortion procedure compared to women who~     do not receive abortion doula support.~   "
85524|NCT01937975|"~     Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of~     combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic~     (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with~     end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal~     impairment. Both groups were compared to healthy matched controls.~   "
85525|NCT01937949|"~     This study will compare two groups of subjects with complex abdominal aortic aneurysms. It~     will compare their clinical outcomes and quality of life measures. The group being treated~     in this study will have their aneurysms repaired by an endovascular approach using Zenith®~     Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients~     (historical cohort) whose complex aneurysms were treated by open surgical repair.~   "
85526|NCT01937936|"~     Family caregivers are vulnerable to health problems because of the stress and demands of~     their role as a caregiver. With the growing incidence of heart failure (HF) and the~     anticipated growth in the aging population, the number of HF caregivers is expected to rise.~     This study will pilot test a cognitive behavioral intervention designed to reduce stress~     among HF caregivers, which will ultimately contribute to promoting health and quality of~     life among HF caregivers and their loved ones with HF.~   "
85527|NCT01937923|"~     This observational study will establish a clinical baseline and measure changes over time in~     movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with~     early stage Huntington's disease. Participants enrolled in this study may be eligible to~     participate in a future planned study of stem cell therapy for Huntington's Disease (HD).~      In-person study visits occur at screening, baseline, and every 6 months thereafter for a~     minimum of 12 months, with interim phone call assessments.~   "
85528|NCT01937910|"~     The main goal of this research is to advance understanding of how stroke changes both the~     structure and function of the brain. The investigators will determine which is the key~     driver of recovery of arm function after stroke: changes in the structure of the brain or~     changes in how brain regions interact with one another.~   "
85529|NCT01937897|"~     In depression, EEG studies have shown frontal asymmetry with relatively lower activity in~     the left hemisphere. In this study a moderate pressure massage will be conducted by a~     trained professional on one of the following conditions: the right side of the body, the~     left side of the body, or both sides of the body (a traditional massage on the back of the~     body) while EEG measurements of brain activity are recorded and mood ratings are obtained.~   "
85530|NCT01937884|"~     Optimal delivery of nutritional support during critical illness is central to appropriate~     intensive care unit management, and yet fundamental gaps in knowledge exist regarding~     timing, route, dose, and type of nutritional support for critically ill infants and~     children. Understanding how to optimize nutritional support during pediatric critical~     illness is important because even brief periods of malnutrition in infancy result in~     permanent negative effects on long-term neurocognitive development. Optimized nutrition~     support is a way to improve morbidity for survivors of pediatric critical illness.~     Parenteral nutrition (PN) supplementation could improve long-term neurocognitive outcome for~     pediatric critical illness by preventing acute malnutrition, but has unknown effects on~     intestinal barrier function; a proposed mechanism for late sepsis and infectious~     complications during critical illness.~      While randomized controlled trials (RCT) support early PN in premature infants and late PN~     in critically ill adults, the optimal time to begin PN is unknown for critically ill infants~     and children. Acute malnutrition may develop within 48 hours of admission in critically ill~     infants and children, and repleted energy stores are predictive of survival. And yet, due to~     concerns for PN-associated infectious morbidity, current PICU standard of care is to~     supplement with PN only in children who fail to enterally feed, as late as 7 days into their~     admission. Delays in nutrition may have long-term effects on cognitive outcome in older~     infants and children. In premature infants, PN begun within hours of birth results in~     improved 18-month neurocognitive outcome without an increase in infectious complications. An~     RCT is needed to determine if early PN in critically ill infants and children prevents acute~     malnutrition and improves short and long-term outcomes of PICU hospitalization.~      The central hypothesis of this proposal is that optimized early protein and calorie delivery~     will improve nutritional outcomes and intestinal barrier function for critically ill infants~     and children. The overall purpose of this study is to evaluate the efficacy and safety of~     early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional~     outcomes, and intestinal barrier function for infants and children with acute respiratory~     failure who are mechanically ventilated in the pediatric intensive care unit.~   "
85531|NCT01937871|"~     The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in~     men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract~     Symptoms (BPH-LUTS) and improve their quality of life.~   "
85534|NCT01937832|"~     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in~     community-acquired pneumonia (CAP) subjects~   "
85537|NCT01937793|"~     This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise~     programs for patients with NPC after radiation therapy. This study also compares two~     different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one~     can bring more benefits to patients after a certain period of exercise training. Three~     assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing~     Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing~     Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the~     effortful swallowing exercise would have better treatment efficacy.~   "
85538|NCT01937780|"~     This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal~     cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The~     utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be~     investigated. Molecular and genetic markers in tumor and blood will be analyzed for~     prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence,~     sexual dysfunction and quality of life will be assessed. A structured intervention program~     for management of late effects will be evaluated. Symptom relief of palliative radiotherapy~     will be investigated. The main purpose of the study is to increase the knowledge of anal~     cancer treatment, improve treatment results, and improve anal cancer survivor care.~   "
85539|NCT01937767|"~     This phase II study in patients undergoing elective cardiac surgery will evaluate the~     efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and~     sevoflurane, during the induction and maintenance of general anesthesia.~   "
85540|NCT01937754|"~     Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy~     adults with clinical prehypertension.~   "
85541|NCT01937728|"~     The purposes of this study are:~        1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to~          standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and~          HVL~        2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is~          superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at~          week 12~   "
85542|NCT01937715|"~     This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal~     carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus~     FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of~     PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.~      The study population will consist of patients with mCRC previously treated with an~     oxaliplatin-based regimen in the first line setting or who have progressed within 6 months~     of the end of an adjuvant oxaliplatin-based regimen.~   "
85543|NCT01937702|"~     A trial, investigating the influence of injection speed and volume on the perception of~     subcutaneous injection pain.~   "
85544|NCT01937689|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.~     This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with~     HER2 positive advanced breast cancer:~        -  To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose~          (MTD)~        -  To determine the dose-limiting toxicity (DLT)~        -  To determine the pharmacokinetic profile of Pyrotinib and its metabolites~        -  To assess preliminary antitumor activity~        -  To determine preliminary regimen dose for phase II study~        -  To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.~   "
85545|NCT01937676|"~     The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the~     emergency department can be used to predict the development of organ failure measured as~     SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.~   "
85546|NCT01937663|"~     The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in~     chronic constipation patients.~   "
85547|NCT01937650|"~     The objective of the study was to determine whether there was a difference in the~     effectiveness of Radiotherapy alone compared with Radiotherapy plus Metronidazole in the~     treatment of women with advanced cancer of the cervix in Mulago hospital. It was a~     randomized controlled trial composed of 38 women altogether, with one group composed of~     randomly selected women with advanced cancer of the cervix treated with radiotherapy alone~     and the other group composed of similar women but treated with radiotherapy and~     metronidazole.~   "
85548|NCT01937637|"~     Many individuals with lung cancer experience debilitating breathlessness at some point~     during the course of their illness. Unfortunately, few interventions exist to treat this~     distressing symptom of cancer.~      In this study, the investigators plan on recruiting individuals with lung cancer to~     participate in a behavioral intervention to help relieve breathlessness. The principal~     investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has~     trained nurse practitioners in how to deliver the behavioral intervention. The nurse~     practitioners will meet with patients diagnosed with lung cancer during their outpatient~     oncology appointments, such as chemotherapy infusions, to review the behavioral skills that~     may help with breathlessness. Specifically, the intervention includes education about the~     relationship between breathlessness and the stress response as well as teaches patients~     skills for breathing control and relaxation of the body.~      For this single-group pilot study, the investigators will ask participants to provide~     feedback about whether they found the intervention acceptable and effective. Participants~     will also complete questionnaires about their physical and psychological symptoms before and~     after the intervention in order to measure its effectiveness for treating breathlessness and~     any distress related to breathlessness. The data from this study will help inform~     improvements to the intervention in order to make it feasible and effective for treating~     breathlessness in patients with lung cancer.~   "
85549|NCT01937624|"~     The purpose of the study is to evaluate the sensitivity and specificity of using a~     diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient~     setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic~     ultrasound will be compared to x-ray diagnosis under routine conditions in the~     investigator's injury and fracture treatment evening clinic. Data will be collected and~     recorded during the duration of the 12 week study. Through the literature review and~     experience with ultrasound, the investigators anticipate that diagnostic ultrasound will~     provide very high sensitivity and specificity in diagnosing distal radius fractures in~     children.~   "
85550|NCT01937611|"~     Many studies have been conducted for the feasibility of using dexmedetomidine as~     premedication. However, bradycardia and hypotension frequently occurred following the~     premedication with dexmedetomidine, either via intramuscular or intravenous route. This is~     particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2~     μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and~     mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further~     revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes.~     Most studies using high-dose dexmedetomidine were predominantly adopted with the~     dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of~     intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1~     midazolam. However, few investigations have addressed the clinical effects of low-dose~     dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way~     towards eliminating the routine need for a deep preoperative sedation. It has, therefore,~     become desirable to asses dexmedetomidine as an effective premedication using a moderate~     sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to~     compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction~     of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used~     premedication, used as an intramuscular injective administration in patients undergoing~     suspension laryngoscopic surgery under general anaesthesia.~   "
85551|NCT01937598|"~     Objectives: To quantify differences in control of glycemia (primary objective) and the~     secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or~     placebo added to pre-existing therapy with liraglutide and metformin~   "
85552|NCT01937585|"~     The purpose of this study is to determine whether female partners of African American men~     can promote initiation of a discussion with a healthcare provider about prostate cancer~     screening when the partner is supported by a print message designed to provide relevant~     information and strategies for her to use in this effort.~   "
85553|NCT01937572|"~     The purpose of the current study is to validate the technology of MRI-based alignment for~     total knee replacements and to collect data on potential advantages of the computer aided~     system.~        1. It is hypothesized that there will be no significant differences in position,~          loosening, or function of the Visionaire total knee as compared to the conventional~          total knee.~        2. It is hypothesized that the Visionaire total knee will be significantly better with~          regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover~          time, and overall costs.~   "
85554|NCT01937559|"~     The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in~     decreasing blood loss following both shoulder arthroplasty and primary total hip~     arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system~     within the body. The investigators hypothesize that topical application of TXA prior to~     closure reduces postoperative bleeding as measured by absolute changes in postoperative~     hemoglobin levels and surgical drain output. In addition, use of topically applied~     tranexaminic acid may reduce the need for transfusions, the rates of hematomas, infections,~     and length of hospital stay.~   "
85555|NCT01937546|"~     It is unknown if primary delivery of the anterior or the posterior shoulder causes less~     perineal tear. The objective of this trial is to evaluate the incidence and degree of~     perineal trauma after primary delivery of the anterior shoulder compared to primary delivery~     of the posterior shoulder during vaginal birth in primiparous women in a randomized~     controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces~     the rate and degree of perineal trauma.~   "
85556|NCT01937533|"~     This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance~     Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil~     has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS~     Foundation Trust for use at high field strengths(3T). This will be used to evaluate if~     DW-MRI at 3T can be used to differentiate different histological characteristics within~     whole tumours and so determine if the technique could be of prognostic value.~      The study hypothesis is that this technique will be able to differentiate tumours with~     histological features known to be associated with poor prognosis (tumour type, grade and~     lymphovascular space invasion).~   "
85557|NCT01937520|"~     This study is being done because the investigators wish to study ways to improve recovery~     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the~     body's attempt to protect itself and to start the healing process. Some surgical~     complications are related to the body's natural inflammatory response. Although mainly a~     healing response, inflammation can also have side effects which delay recovery. The~     investigators wish to determine the effect of acupuncture on post-operative surgical pain.~     An increase in pain after surgery can cause distress for patients. Acupuncture is an~     alternative medicine methodology originating in China that treats patients by manipulating~     thin, solid needles that have been inserted into acupuncture points in the skin. Acupuncture~     has been used for the reduction of pain. The investigators would like to see if acupuncture~     during surgery can provide a lower level of pain, reduced pain medication requirement, and a~     lower incidence of nausea and vomiting.~   "
85558|NCT01937507|"~     Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or~     liver-predominant metastases who have failed at least one line of systemic chemotherapy in~     metastatic setting.~   "
85559|NCT01937494|"~     Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial~     challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are~     used to avoid passive exposure of the technicians performing the test, despite the absence~     of evidence that they could develop a bronchoconstriction even if they suffer from BHR.The~     purpose of the study is to determine if patients with a high level of bronchial~     hyperreactivity and exposed passively to histamine during a bronchial challenge, are~     developing a bronchoconstriction, when placed in the same conditions that the technicians~     performing these tests.~   "
85572|NCT01937325|"~     Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation.~     Improvement in ventilation, salt balance and well-being will contribute to better exercise~     capacity at all levels of lung function. While potential improvements may be variable across~     the spectrum of lung function, even small gains at low levels of FEV1 may have significant~     benefit for some subjects.~   "
85560|NCT01937481|"~     The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social~     ecological approach to explore individual, family and environmental factors and their~     relationship to child weight status over a 3 year timeframe. Our primary research questions~     are as follows:~        1. Are behavior changes (increased willingness to try new foods and gross motor skills)~          from a preschool nutrition and activity program, The Food Friends®, sustained through~          early elementary school?~        2. Do The Food Friends® programs have an impact on reducing the percentage of children~          considered overweight and/or obese over a 3 year timeframe?~        3. Do food preference and gross motor performance directly affect child weight status or~          are they mediators to dietary intake and physical activity?~   "
85561|NCT01937468|"~     This research study is a Phase I clinical trial, which tests the safety of an~     investigational combination of IL-2 plus donor anti-inflammatory Treg cells and also tries~     to define the appropriate dose of the investigational combination of IL-2 plus donor~     anti-inflammatory Treg cells to use for further studies. IL-2 is involved with cell~     signaling and regulation of white blood cells (WBCs). WBCs are part of the immune system.~     Treg cells are also part of the immune system; they are involved with anti-inflammatory~     responses. Investigational means that the combination of IL-2 and anti-inflammatory Treg~     cell infusion is being studied. It also means that the FDA (U.S. Food and Drug~     Administration) has not approved the combination of IL-2 and anti-inflammatory Treg cell~     infusion for use in people with cGVHD.~      Chronic GVHD is a medical condition that may occur after you have received your bone marrow,~     stem cell or cord blood transplant from a donor. The donor's immune system may recognize~     your body (the host) as foreign and attempt to 'reject' it. This process is known as~     graft-versus-host disease.~      Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this~     trial have not responded to steroid therapy. The investigators are looking to assess the~     safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells,~     that may help control cGVHD by stopping the donor's immune system from 'rejecting' your~     body.~   "
85562|NCT01937455|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male~     adults.~   "
85563|NCT01937442|"~     Objective of this study is to characterize the steady-state pharmacokinetics (PK) of~     thalidomide when given orally as monotherapy to subjects with multiple myeloma.~   "
85564|NCT01937429|"~     The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the~     colon and rectum. Mass screening assessment studies have shown that colonoscopic detection~     and removal of adenomas in patients selected through fecal occult blood test reduces~     colorectal cancer incidence and mortality. However, the literature has reported interval~     cancer cases or adenomas, probably missed by the colonoscopy. In theory, using coloured~     warm water could improve colon preparation by mobilizing the residual faeces, decreasing the~     colic spasm and increasing the visualization of the pit pattern. Preliminary American~     studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.~      The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne~     region. The patients present an indication for colonoscopy following a positive fecal occult~     blood test or symptoms or personal and family histories of pre-cancerous colonic lesions.~     They will be randomized into two study groups:one of both groups of study: Group 1: patients~     undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®)~     Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main~     objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection~     of more lesions than standard colonoscopy with insufflation of air. The two techniques will~     be also compared in terms of tolerance, of duration of colonoscopy and type of detected~     lesions.~      In case of improved detection of colorectal lesions, the blue water instillation technique~     of could dramatically change gastroenterologists' practice by becoming the reference method.~     The expected clinical benefits are potential revealing of more neoplastic lesions and~     improvement in abdominal discomfort after colonoscopy.~   "
85565|NCT01937416|"~     This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear~     cells transplantation in diabetic patients with lower limb ischemia.~   "
85566|NCT01937403|"~     The primary purpose of this study is to determine the interrater reliability and validity of~     the Sportcord Test as a measure of physical performance following anterior cruciate ligament~     (ACL) reconstruction. A secondary purpose is to systematically track subjective and~     objective outcomes on patients following ACL reconstruction to help identify differences~     between those who have subsequent knee problems and those who do not. The study hypotheses~     are the following:~      1) The Sportcord Test will provide a valid and reliable measure of functional performance~     following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month~     study period will exhibit different scores on clinical special tests compared to those who~     do not.~   "
85567|NCT01937390|"~     The objective of the study is to observe the effect of adherence to once-daily administered~     long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic~     antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the~     relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease~     (COPD) maintenance therapy~   "
85568|NCT01937377|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into~     three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European~     Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for India and~     Switzerland. The total number of patients enrolled in three protocols is estimated to be~     48,000 patients, and all these patients will be included in the data analysis for study~     1160.129.~   "
85569|NCT01937364|"~     The purpose of this study is determine if the medication baclofen can prevent the symptoms~     of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS.~     This medication is most often used for patients who have spasticity of their muscles due to~     a neuromuscular disease. In several European studies, and in an earlier study at Essentia~     Health (NCT00597701), baclofen has been found to have a significant effect on the severity~     of symptoms of AWS.~   "
85570|NCT01937351|"~     A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an~     atherectomy device that provides directional visualization and imaging as an adjunct to~     fluoroscopy to aid removal of plaque in diseased lower extremity arteries.~   "
85571|NCT01937338|"~     Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an~     endotoxin challenge.~   "
85650|NCT01936506|"~     This study is evaluating the effects of two brain training exercises on: memory, cognitive~     processing and depression symptoms.~   "
85576|NCT01937273|"~     Cancer patients are one of the patient groups at highest risk for the development of~     malnutrition. Anti-cancer treatments, such as chemotherapy and radiotherapy, can further~     heighten the risk due to the nutrition-related toxicities experienced during this time.~      This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing~     treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to~     nutritional deterioration and determine if there is a difference between Indigenous and~     non-Indigenous patients.~   "
85577|NCT01937260|"~     This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in~     subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of~     brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects~     with moderate to severe plaque psoriasis.~   "
85578|NCT01937247|"~     The main purpose of the study is to examine whether operating room (OR) efficiency will be~     improved by significantly decreasing non operative time. This study also aims: 1) to~     evaluate whether a decrease in non-operative time will result in increased surgeon and staff~     satisfaction, 2) to determine whether there is an increase in the complication rate during~     the redesigned process perioperatively and until discharge from the post anesthesia care~     unit, and 3) to rate patient satisfaction.~   "
85579|NCT01937234|"~     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a~     perspective of maternal and fetal well-being , and for the providers of the birth services.~     Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and~     would translate into a major improvement in maternal satisfaction with the child birth~     experience.~      The purpose of this study is to determine the effectiveness of metoclopramide for reducing~     the duration of spontaneous labor among nulliparous women managed according to a standard~     intrapartum protocol.~   "
85580|NCT01937221|"~     The goal of this study is to create new retinal imaging processing software useful for the~     development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's~     disease (AD).~   "
85581|NCT01937208|"~     Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with~     localized carcinoma of the esophagus selected for nonsurgical treatment. The standard~     radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology.~     Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend~     radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III,~     randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent~     chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.~   "
85582|NCT01937195|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt PIV placement, higher completion of therapy, fewer complications,~     longer dwell times and higher user satisfaction compared to Conventional IV Catheters.~   "
85583|NCT01937182|"~     We wish to conduct a prospective, randomized, double blind, placebo controlled multi center~     study of the combined neuroprotective and antithrombotic effects of SSRI treatment after~     stroke.~      Hypotheses:~      SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new~     thromboembolic events and leads to better rehabilitation. 600 stroke patients will be~     randomized in a 1:1 ratio.~      The treatment and follow up period is 6 months. During these 6 months there will be 2~     clinical follow up visits, one telephone control and one visit to evaluate compliance~     regarding medication.~   "
85584|NCT01937169|"~     Neurons in the brain require blood and oxygen for proper function. The term neurovascular~     coupling has been postulated in the 19th century by Roy & Sherrington referring to~     increased blood flow to active neurons. The rationale of this research relies on the~     neurovascular coupling, suggesting that increased blood flow to active regions on the brain~     should supply not only more blood, but also more of a pharmacological agent present in the~     blood system at the time. Thus, active regions should be affected by the agent (=drug) to a~     greater extent.~      In the present study we focus on the dopaminergic system, critical in many functions such as~     cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in~     the brain is the nigrostriatal pathway, mediating motor function. In this research, we~     intend to examine the effects of coupling functional activation in this pathway with a~     dopaminergic agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is~     characterized by an irresistible urge to move the limbs (i.e. Akathisia), and results most~     prominently by a significant decrease in the quality of sleep. Our research focuses on this~     symptom of RLS to examine the effect of coupling brain activation and drug treatment.~      The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine~     levels in motor pathways, and our research will aim to couple activation in the~     nigrostriatal motor pathway with dopaminergic treatment in RLS. Functional activation will~     be achieved with a simple motor task, known to elicit activation in the nigrostriatal~     pathway. We hypothesize that the drug will act upon the pre-activated motor system, and that~     this coupling between brain activation and drug treatment will ameliorate sleep-related~     symptoms of RLS, compared with treating these symptoms solely with a dopaminergic drug and~     compared with using a non-motor task.~   "
85585|NCT01937156|"~     The purpose of this study is to assess the efficacy and safety of SP-01 in~     chemotherapy-induced nausea and vomiting (CINV) associated with the administration of~     moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide~     scientific and reliable clinical data in the drug registration in China.~   "
85586|NCT01937143|"~     Immunization injections are the most common recurring painful medical procedure undertaken~     in childhood. Numerous evidence-based and feasible interventions are available to mitigate~     immunization pain, however, there is low uptake of these interventions in clinical practice,~     revealing a knowledge-to-care gap between what is known about pain and pain management. This~     is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420~     mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in~     Toronto. The trial will evaluate and compare the impact of two levels of intensity of~     maternal education about pain management during infant immunizations ('low': pamphlet vs.~     'high': pamphlet + video) compared to placebo control after the birth of an infant on~     maternal behaviour during future infant immunizations at up to 6 months of age (use of~     analgesic interventions), maternal knowledge and attitudes about pain and pain management up~     to 6 months after birth.~   "
85587|NCT01937130|"~     The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary~     efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more~     than 24 hours due to acute deterioration of liver function.~   "
85588|NCT01937117|"~     This research is being done to determine if early changes on a type of imaging procedure~     called PET (Positron Emission Tomography) can predict which patients are most likely to~     respond to the combination of trastuzumab and pertuzumab when given prior to surgery.~   "
88223|NCT01902524|"~     The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal~     patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic~     non-cancer pain.~   "
85589|NCT01937104|"~     Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be~     associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with~     ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a~     noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to~     investigate the change of ONSD according to the positional change during laparoscopic~     surgery.~   "
85590|NCT01937091|"~     Purpose: To comprehensively explore the barriers and motivators for participation in HIV~     clinical trials in a purposive sample of HIV positive patients receiving care at the UNC ID~     (Infectious Diseases) clinic Participants: HIV positive patients seen at the UNC ID Clinic.~     Participants will be purposively sampled based on gender, race and previous participation in~     HIV clinical trials. Blacks and patients who have never participated in clinical trials will~     be oversampled.~      Procedures (methods): Cross-sectional study using in-depth semi-structured qualitative~     interviews to determine the barriers and motivators for participation in HIV clinical~     trials. Patient interviews will be audiotaped, transcribed verbatim and analyzed using~     Atlas.ti software to understand the barriers and motivators for participation in HIV~     clinical trials.~   "
85591|NCT01937078|"~     Levodopa-induced dyskinesia is a common problem in Parkinson's disease (PD). In particular,~     targeting non-dopaminergic systems may be an option for reducing dyskinesia without~     worsening motor symptoms. One such target may be histamine. The central histaminergic system~     is involved in diverse biological functions including thermoregulation, eating, and sleep; a~     role in motor activity is suggested by strong histaminergic innervation of the basal~     ganglia. Histamine H2 receptors are highly expressed in the striatum, particularly on the~     GABAergic striatal-pallidal and striatal-nigral pathways Histamine H2 stimulation modulates~     acetylcholine release. Previous studies have demonstrated that blocking acetylcholine with~     anticholinergic agents can induce chorea. The investigators propose that histamine H2~     receptor stimulation decreases acetylcholine in the striatum and increases activity of the~     direct striatal output pathway, a key component of the neural mechanisms underlying~     dyskinesia.~      The investigators hypothesise that H2 antagonists would reduce activity of the direct~     striatopallidal pathway and so potentially reduce levodopa-induced chorea~      Famotidine has also been assessed in schizophrenia in a small cases series to treat~     schizophrenia, with tolerability. Clinical experience thus suggests the suitability of using~     this agent as a histamine H2 antagonist in clinical studies for PD.~   "
85592|NCT01937065|"~     Study of heterogeneity in associations between social deprivation and the initial~     presentation of 12 cardiovascular diseases.~   "
85593|NCT01937052|"~     The purpose of this project is to establish a repository of information and samples from~     breast cancer patients or those at high risk of developing breast cancer, who are initiating~     hormone therapy as part of standard clinical care or prevention. This repository will~     include patient reported outcomes and other questionnaires, information on medication use,~     data about adherence to the hormone therapy and tumor characteristics, including~     prospectively collected samples.~   "
85594|NCT01937039|"~     The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill~     the research mission of the Breast Cancer Program at Johns Hopkins and to serve~     investigators affiliated with it - to develop a repository of specimens with corresponding~     characteristics from patients seen in the breast care and cancer clinics.~   "
85595|NCT01937026|"~     The purposes of this study are to assess how the body handles baricitinib when it is given~     with another drug called probenecid. The study doctor will measure the amount of baricitinib~     that is absorbed into the blood stream and the time that it takes to remove baricitinib from~     the body. The safety and tolerability of these drugs will be studied. The study will last~     about 18 days from the first dose to the end of the study (not including screening.)~   "
85596|NCT01937013|"~     This study will evaluate the effects on emotions and neural activity of a one time dose of~     intranasal oxytocin vs. placebo in patients with FTD and healthy controls.~   "
85597|NCT01936181|"~     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in~     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)~     therapy.~   "
85598|NCT01936168|"~     The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that~     combines mechanical endothelial damage using a rotating wire with the infusion of a liquid~     sclerosant. Heating of the vein and tumescent anesthesia are not required; only local~     anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA,~     using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV)~     incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of~     this technique in terms of obliteration rates are lacking. This randomized trial was~     designed to compare occlusion rate, post-operative pain and complications between~     radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.~   "
85599|NCT01936155|"~     Neuromuscular Electrical Stimulation (NMES) will be facilitated through the use of a~     stimulator, with the patient in a semi recumbent position, using UltraStim electrodes. Two 5~     cm x 5 cm electrodes will be placed over the soleus muscle for calf stimulation. The~     participant will be allowed to ramp up the stimulus level themselves to get used to the~     sensation and determine their maximum tolerated stimulus level.~      A goniometer will be used to assess mobility at the knee and ankle joints. Transcutaneous~     oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 500 tcpO2~     monitor.~      The level of oedema will be measured using the figure of eight measurement, tape~     circumference measurement and water displacement measurement.~      Comfort will also be assessed by use of a 100mm non-hatched visual analogue scale (VAS).~     Each participant will be asked to indicate their level of comfort following the application~     of NMES.~   "
85600|NCT01936142|"~     The purpose of this study is to determine whether the use of RenalGuard system which creates~     high urine output with fluid balancing may prevent contrast induced nephropathy in patient~     undergoing cardiac resynchronization therapy (CRT) implantation.~   "
85852|NCT01933633|"~     Overweight/obesity is associated with sub-fertility. The investigators will assess if~     regular exercise training prior to assisted fertilization will improve pregnancy rate in~     overweight/obese women referred to assisted fertilization. It is expected that training will~     be successful in increasing pregnancy rate~   "
85601|NCT01936129|"~     This is a randomised controlled trial to assess the neuroprotective effect of Cop-1~     (Copaxone) in patients with acute primary angle closure (APAC). The standardized management~     of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser~     peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a~     subcutaneous dose once within 24 hours of presentation, and then one week later (total 2~     injections). The control group will have placebo in addition to standard regimen. Subjects~     in the study will have visual field test performed with the Humphrey Visual Field Analyzer~     II, retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence~     tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography~     (HRT). At least 2 baseline visual field tests will also be performed in the first week.~     Subsequent visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference~     in visual field, RNFL thickness, and optic nerve head structural changes.~   "
85602|NCT01936116|"~     Saline infusion sonohysterography and other intrauterine investigations methods may cause~     uterine cramping, pain and vasovagal reactions. According to few of previous studies the~     position of catheter placement can affect the magnitude of pain and amount of saline~     required during the sonohysterography. The purpose of this double blind control trial study~     is to assess whether the location of the balloon catheter either the uterus or cervix during~     sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.~   "
85603|NCT01936103|"~     First acute anterior myocardial infarction in patients with primary PCI preoperative and~     postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional~     -dose therapy , patients can improve left ventricular function , reduce major adverse~     cardiovascular events .~   "
85604|NCT01936090|"~     This phase I/II trial studies the side effects and best dose of bortezomib when given~     together with melphalan, and total-body irradiation before stem cell transplant and to see~     how well it works in treating patients with multiple myeloma. Giving chemotherapy and~     total-body irradiation before a stem cell transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. The stem cells that were collected from the~     patient's blood or bone marrow are returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy and total-body irradiation.~   "
85605|NCT01936077|"~     The ideal stimulation protocol for ovarian stimulation is under constant debate, as we gain~     more pharmacological control over the patient hormonal milieu. Specifically, the debate~     focuses around the ideal LH levels. The concept of an LH window was suggested.~      The need for a threshold level of LH is clearly demonstrated in hypogonado-tropic~     hypogonadism patients, but also in cycling patients receiving high doses of GnRH antagonist.~     The Ganirelix dose finding study demonstrated very low implantation rates in the high dose~     groups (1 mg, 2 mg).~      The stimulation dynamics in these patients were remarkable for very low E2 and LH levels on~     the day of hCG. In fact, a functional state of hypogonadotropic hypogonadism is achieved,~     explaining the poor clinical results (1.5% implantation rate under 2 mg Ganirelix). The same~     protocol was repeated with added Luveris resulting in excellent pregnancy rates.~      The recommended daily dose of GnRH antagonist is 0.25 mg which on the average provides a~     protection from premature LH surge, with moderate suppression of LH. Therefore, most~     patients do not need supplemented LH after the antagonist is initiated.~      However, there is a subgroup of patients who hyper-respond to the antagonist (in 0.25 mg~     dose) with a sharp decrease in LH. This explains contradictory findings in the available~     studies. The basic assumption in the background of this proposal is that there is a wide~     range of pituitary responses to GnRH antagonist. Obeying a bell-shape curve, most women have~     an average response, however, some hypo-respond might ovulate prematurely, and others~     hyper-respond. In the latter cases, pituitary response will behave as if exposed to a higher~     dose.~      How to identify an exposure to a presumed higher dose?~      Below is a figure from the original paper. A close look indicates that the immediate~     response to all Ganirelix doses are similar in terms of LH drop, however, the big difference~     lies in the pituitary recovery 24 hours post Ganirelix dose.~      While small doses allow for a quick recovery to almost pre-treatment LH levels, high doses~     result in incomplete recovery. Hence, it is reasonable to speculate that the high response~     to 0.25 mg dose will lead to slow or incomplete recovery of LH levels 24 hours post the~     initial dose.~      It is estimated that about 15% of patients are antagonist hyper-responders. Efforts to~     individualize patient protocol must target this group as candidates for supplemented LH.~     This estimate is similar to study findings: Huirne et al Human Reproduction 2005, 20: 359.~   "
85606|NCT01936064|"~     To determine the effective functionality/potency of Jobelyn as an immunologic and~     haematologic booster in Breast cancer patients (start-off), thus improving the outlook and~     the quality of life of such patients generally~   "
85607|NCT01936051|"~     To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma~     concentration and the transporter occupancy from OCD patients treated with escitalopram.~      To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the~     PK-PD modeling in OCD patients treated with escitalopram.~   "
85608|NCT01936038|"~     The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which~     happens at night and consists of the interruption of airflow for more than five seconds. His~     current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative~     and therefore the level of compliance is key to patient improvement. Many patients don´t~     tolerate CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium~     of non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These~     techniques are: oropharyngeal exercises executed actively by the patient for the muscle~     toning of the upper airways, electrostimulation of the muscles in the floor of the mouth,~     correction of the tongue position, nasal and bronchial fogging, execution of respiratory~     gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical~     column,and massage in the diaphragm. All the techniques together seek for a greater or~     lesser impact on the upper airways hypotony, the hypotony of the tongue and the soft palate,~     the jaw retrognathism, the mouth breathing, the vertebrobasilar syndrome, the~     gastroesophageal reflux, the excessive accumulation of secretions in the upper and lower~     airways, the obstructive and restrictive respiratory problems, the sleeping posture, the~     hypertonia of the diaphragm due to the excess effort in trying to overcome the respiratory~     obstruction. All these disfunctions will make easier for the patient to show side effects in~     the use of CPAP. There will be a double-blind randomized controlled study with 110~     individuals. One group will follow the conventional medical treatment with CPAP and the~     other group medical treatment plus Upper Airway Toning. After six months, the mean~     improvement between the two groups will be compared.~   "
85609|NCT01936025|"~     The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way~     cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for~     participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM~     60 mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone,~     or placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be~     started 1 hour after study drug administration and blood glucose will be measured over the~     next 4 hours. There will be a 3 to 14-day washout period between doses.~   "
85613|NCT01935973|"~     This randomized phase II trial studies how well trametinib with or without GSK 2141795~     (protein kinase B [Akt] inhibitor GSK2141795) works in treating patients with endometrial~     cancer that has come back (recurrent) or does not go to remission despite treatment~     (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib~     is a more effective treatment for endometrial cancer when given with or without ATK~     inhibitor GSK2141795.~   "
85614|NCT01936974|"~     To evaluate progression-free survival with two chemotherapy regimens on~     platinum-resistant/refractory ovarian and peritoneal carcinoma~   "
85615|NCT01936961|"~     The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for~     complete response in solid tumors~   "
85616|NCT01936948|"~     The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the~     detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of~     transition to cancer increases with polyp size, effective and safe resection of large polyps~     is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal~     resection (EMR) using electrocautery snares. Resection of these large polyps is associated~     with a risk of severe complications that may require hospitalization and additional~     interventions. The most common risk is delayed bleeding which is observed in approximately~     2-9% of patients. A recent retrospective study suggests that closure of the large mucosal~     defect after resection may decrease the risk of delayed bleeding. However, significant~     uncertainty remains about the polypectomy techniques to optimizing resection and minimizing~     risk. Important aspects that may affect risk include clipping of the mucosal defect and~     electrocautery setting.~   "
85617|NCT01936935|"~     The aim of this trial is to evaluate the effects of dairy product consumption on insulin~     sensitivity and pancreatic β-cell function in men and women at risk for the development of~     type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet~     sodas and fruit juice cocktails).~   "
85618|NCT01936922|"~     A virtual reality device has already been successfully used for improving gait in adults who~     have neurological conditions. We will evaluate if it is feasible to study the brief use of~     this device in older adults who have had falls.~   "
85619|NCT01936909|"~     The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1~     blocker) in patients with recently decompensated heart failure to determine the safety and~     efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a~     cardiopulmonary exercise test.~   "
85620|NCT01936896|"~     Acute myocardial infarction is characterized by an intense inflammatory response.~      The degree of the response influences clinical outcome, with 'more' inflammation promoting~     heart failure. In this study we plan to determine whether treatment with plasma derived~     alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment~     elevation myocardial infarction (STEMI).~   "
85621|NCT01936883|"~     Optimal non surgical treatment of prostate cancer requires dose escalation which is~     frequently provided by adding a brachytherapy boost to a short course of external beam~     radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR)~     brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA)~     recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that~     it is associated with a more favorable toxicity profile and improved quality of life.~   "
85622|NCT01936870|"~     The purpose of this study is to collect effectiveness and safety information of fesoterodine~     related to their appropriate use in daily practice.~   "
85623|NCT01936857|"~     The purpose of this study is to compare two models of substance abuse treatment in Vietnam,~     and how they each affect HIV care. In Vietnam, the current model for treating people with~     HIV who are also dependent on opioids is to refer them to methadone maintenance treatment~     centers. The new model the protocol will study is treatment of HIV and opioid dependence~     with buprenorphine/naloxone and counseling in the HIV clinic.~   "
85624|NCT01936844|"~     Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human~     interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart~     failure with the aim to quench the acute inflammatory response, as measured by the~     area-under-the-curve for C reactive protein over 14 days.~   "
85625|NCT01936831|"~     Isoniazid (INH) is a drug commonly used to treat TB worldwide. Sometimes, the bacteria that~     cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug~     and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does~     not work as well at fighting the bacteria. This study will treat people with INH-resistant~     TB with different doses of INH to see if INH can still fight the bacteria if we just~     increase the dose. We will compare how well the drug works at higher doses for participants~     who have resistant TB to how well the drug works at regular doses for participants who have~     TB that is not resistant. The study will also compare the safety and tolerability of the~     different doses of INH. Tolerability is how well people can put up with the side effects of~     a drug. Using increased doses of INH to treat TB that is resistant to INH is experimental~     and has not been approved by regulatory authorities. While there is some evidence that this~     approach will work, this has not yet been proven.~      This study will be done in two stages. Stage 1 is a pilot study to determine the feasibility~     of enrolling enough participants into Stage 2, the larger stage of this study. If Stage 1 is~     successful, then Stage 2 will begin.~   "
85626|NCT01936818|"~     A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal~     Allergen Challenge (NAC) in a Dust Mite Population~   "
85627|NCT01936805|"~     The aim of the present study was to evaluate the effect of pre-procedural single high~     loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and~     composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel~     revascularization (TVR), or stroke.~   "
85651|NCT01936493|"~     The purpose of this study is to search for the hereditary (genetic) causes of uterine~     fibroids. Some women with uterine fibroids may have one or more genes that make them more~     likely to develop uterine fibroids. We are trying to identify these genes to better~     understand how and why uterine fibroids develop and to design better treatment options for~     women with uterine fibroids. This information may also help us to understand and treat other~     problems that may be caused by these genes.~   "
85628|NCT01936792|"~     The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and~     resting state functional MRI to examine tissue damage in the brains of people who have had a~     concussion, both acute and 3 months after the accident. A secondary purpose is to examine~     whether the results of the scans are associated with physical, cognitive and emotional~     problems after concussion.~      It is hypothesized that there will be a change in the diffusion signal measured with DKI in~     the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at~     follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected~     that there will be changes in the diffusion signal measured with DKI and DTI in other WM and~     GM area in both the acute stage and at follow up with mTBI subjects compared with healthy~     controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover~     secondarily the MRI markers are tested for correlation with the severity of PCS acutely and~     at follow up after mTBI.~   "
85629|NCT01936779|"~     High levels of fatty substances in the blood increase the risk of developing heart disease.~     Investigators know a lot about one of these fatty substances, cholesterol. However, there is~     another fatty substance in the blood called triglyceride. Investigators do not understand~     much about what regulates the rate at which the liver produces triglyceride and liberates it~     into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the~     amount of blood triglyceride however, it remains unclear how this happens. Investigators~     will study if changes in liver fat metabolism, after taking fatty acids found in fish oil~     (n-3 fatty acids)can explain the lowering of blood triglyceride. Investigators also want to~     know if taking fish oil alters the amount of fat that accumulates within the liver.~   "
85630|NCT01936766|"~     Optimal fluid therapy in severe falciparum malaria has not been well defined, especially in~     resource poor settings where access to mechanical ventilation is limited. Recent studies~     suggest that liberal fluid resuscitation is harmful for severe malaria patients despite they~     often being hypovolemic on admission. In order to elucidate the minimum fluid therapy~     required to prevent complications in severe malaria, we will conduct a prospective~     observational study in adults with severe malaria, and also in adults with severe sepsis as~     a comparison group. The objective of this study is to describe the association between~     hemodynamic variations in conventional fluid management and the probability of developing~     acute kidney injury (AKI) or pulmonary edema in adults with severe malaria and severe~     sepsis. Hemodynamic measurements will be obtained by using transpulmonary thermodilution and~     arterial pulse contour analysis.~   "
85631|NCT01936753|"~     Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of~     mother-to-child transmission of HIV) services. Only 20 to 30% of pregnant women living with~     HIV are provided anti-retroviral drugs for PMTCT. Only 4% of HIV-exposed infants receive HIV~     testing for early diagnosis by age 2 months. Furthermore, an unacceptably high number of~     women with HIV who are enrolled in PMTCT programs do not complete them. In other words,~     uptake and retention in PMTCT programs in Nigeria is not adequate. Ultimately,~     mother-to-child transmission of HIV is high, almost 30%.~      The investigators expect that Mentor Mothers (women living with HIV who serve as peer~     counselors) will help to improve uptake and successful completion of PMTCT services (eg~     testing and appointments), for reduced MTCT rates. The investigators also expect Mentor~     Mothers to have a positive effect on other outcomes for mothers and babies in PMTCT~     programs, for example, general health, breastfeeding rates, facility deliveries, and~     maternal-infant survival.~   "
85632|NCT01936740|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
85633|NCT01936727|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
85634|NCT01936714|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
85635|NCT01936701|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure~     that uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in~     today's small incision phacoemulsification surgery. Nowadays a multitude of microincision~     IOLs are available, many of them similar but of course with some differences in regard to~     the chemical composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 2 years.~   "
85636|NCT01936688|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of SCH~     900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.~   "
85637|NCT01936675|"~     This study is being done to better understand how genetic information might improve~     assessment of heart attack risk.~   "
85652|NCT01936480|"~     The purpose of this study is to assess the ability of common genetic variants in aggregate~     to predict drug-induced QT prolongation in healthy subjects using moxifloxacin.~   "
85653|NCT01936467|"~     The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a~     standard 22-gauge needle using either standard-suction or capillary suction methods for~     solid pancreatic lesions. Investigators hope to discover the best technique for obtaining~     diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and~     fine needle aspirate procedure.~      There are currently several techniques for obtaining tissue during endoscopic ultrasound and~     fine needle aspirate. The procedure will be performed by either the capillary suction~     technique or no suction technique.~   "
85638|NCT01936662|"~     Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients~     undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or~     without associated biopsies, is relatively short in length. Unlike adults, who regularly~     undergo this procedure with conscious sedation, children most often require general~     anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of~     children for EGD can result in delayed awakening and slow room turnover, particularly when~     intravenous medications are required for intubation. Laryngeal mask airway (LMA) is an~     alternative to intubation, which permits removal before full awakening.~      Although considered a safe alternative to tracheal intubation in appropriate cases,~     disadvantages of the LMA have been reported including kinking, occluding view of the~     surgical field, failure of placement requiring tracheal intubation, aspiration of gastric~     contents, desaturation, and laryngospasm. The study was designed to determine whether use of~     an LMA for EGD could reduce operating room time, while providing satisfactory conditions for~     the endoscopist, and an equivalent side effect and safety profile as compared to ETT in~     otherwise healthy children with gastrointestinal complaints~   "
85639|NCT01936649|"~     The aim of the study was to assess the reproducibility of quantitative measurements of~     myocardial uptake of Iobenguane I 123 on planar and single photon emission computed~     tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy~     was assessed based upon the absolute differences between quantitative analyses of imaging~     data on 2 scans performed 5 to 14 days apart.~   "
85640|NCT01936636|"~     This Observational Registry study is designed to collect self-reported Transmucosal~     Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access~     program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of~     treatment with Abstral® through the use of Quality of Life and pain measurement tools~     administered via questionnaire.~   "
85641|NCT01936623|"~     The purpose of the study is to determine whether a computerized brief intervention for~     moderate risk drug use among adult primary care patients is more effective than providing~     such patients with a substance abuse assessment alone.~   "
85642|NCT01936610|"~     In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week~     were selected using multi-stage sampling and assigned into two groups randomly.~     Decision-making (before, two weeks after and at admission in maternity department) was~     tested by a researcher -made questionnaire. In experiment group, advantages and~     disadvantages of normal delivery and cesarean-section delivery were presented by~     role-playing in three 90-min scenarios. It was also presented in a 90-min lecture. Data were~     analyzed using SPSS by mean difference test, exact fisher test, independent t-test and~     paired t-test.~   "
85643|NCT01936597|"~     This study must evaluate the benefit of a continuous audio guidance on the effectiveness of~     MCE directed by a volunteer.~      The evaluation of the MCE for this study is based on both quantitative criteria (based on~     the recommendations ERC 2010)~        -  frequency~        -  depth of chest compressions.~      This study compares two methods of continuous audio guide (one arm with an audio continuous~     guidance method by the regulator and second arm with an audio continuous guidance method by~     the controller relayed by an audio) to a method of incentive MCE based on a unique set made~     by the regulator(control arm).~   "
85644|NCT01936584|"~     A multicenter observational study trial validating Quality of Life assessment using EuraHS~     Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic~     unilateral inguinal hernia repair.~      Depending on the treating physician patients will receive a TAPP or TEP repair for their~     inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip~     Mesh).~      Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of~     an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.~      Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year~     postoperative, recurrence rate at 12 months, intra-operative and post-operative~     complications, post-operative hospital stay, operation time and time to place the mesh, VAS~     (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain~     at 3 weeks and 12 months, pain medication needed.~   "
85645|NCT01936571|"~     Lung cancer is the most common cancer type worldwide, with more than 1.1 million annual~     deaths. There are two types of the disease, namely non-small cell lung cancer (NSCLC) and~     small-cell lung cancer (SCLC), with the first accounting for 85% of the total number of~     cases. The 5-year survival across stages remains disappointingly low, around 10% in most~     countries, due to a high incidence of both loco-regional and distant failure [3]. However,~     during the last decade improved radiotherapy techniques allowed an increase of the radiation~     dose, while at the same time more effective chemo radiation schemes are being applied. These~     developments have lead to improved outcome in terms of survival. As the TNM staging system~     is highly inaccurate for the prediction of survival outcome for non-surgical patients,~     attempts have been made to develop a more accurate risk stratification for these patients~     [1,2]. A model based on clinical variables yielded an AUC of 0.74, which was encouraging,~     but also left room for improvement [2]. An extended model, which included clinical as well~     as biomarker variables, reached a higher AUC, but the limited number of patients included in~     this study made it impossible to draw definitive conclusions [1].~      New prognostic parameters can be retrieved from several sources, which include anatomic,~     molecular and functional imaging, genomics, proteomics and clinical analysis of patients.~     The unlimited amount of information is expected to lead to more accurate predictions of~     individual treatment outcome [4].~      The analysis of biomarkers, including proteins, is a fast developing, promising and~     challenging area of research. Biomarkers can measure or evaluate normal biological~     processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.~     Oncoproteins are produced by, or in response to tumor cells, and may be secreted in the~     circulation of patients. As tissue sampling is often not possible in lung cancer patients,~     blood sample collection by venepuncture offers an attractive alternative, which is safe and~     easy to implement. A number of studies described the prognostic and predictive value of~     blood biomarkers for NSCLC [5-7]. In this study we will investigate the prognostic value of~     blood biomarkers related to 1) hypoxia: Osteopontin (OPN), carbonic anhydrase IX (CA-9), and~     lactate dehydrogenase (LDH); 2) inflammation - interleukin 6 (IL-6), IL-8, and C-reactive~     protein (CRP), and α-2-macroglobulin (α-2M); and 3) tumor load: Carcinoembryonic antigen~     (CEA) and cytokeratin fragment (CYFRA 21-1).~        1. Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, et al.~          Development and validation of a prognostic model using blood biomarker information for~          prediction of survival of non-small-cell lung cancer patients treated with combined~          chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and~          NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-368.~        2. Dehing-Oberije C, Yu S, De Ruysscher D, Meersschout S, Van Beek K, Lievens Y, et al.~          Development and external validation of prognostic model for 2-year survival of~          non-small-cell lung cancer patients treated with chemoradiotherapy. Int J Radiat Oncol~          Biol Phys. 2009 Jun 1;74(2):355-362.~        3. Travis WD, Brambilla E, Müller-Hermelink HK, Harris CC. World Health Organization~          Classification of Tumours: Pathology and Genetics of Tumours of the Lung, Pleura,~          Thymus and Heart. Paul Kleihues MD, Leslie H. Sobin MD, editors. Lyon, France: IARC~          Press, International Agency for Research on Cancer; 2004.~        4. Lambin P, Rios-Velazquez E, Leijenaar R, Carvalho S, van Stiphout RG, Granton P, et al.~          Radiomics: extracting more information from medical images using advanced feature~          analysis. Eur J Cancer. 2012 Mar;48(4):441-446.~        5. Donati V, Boldrini L, Dell'Omodarme M, Prati MC, Faviana P, Camacci T, et al.~          Osteopontin expression and prognostic significance in non-small cell lung cancer. Clin~          Cancer Res. 2005 Sep 15;11(18):6459-6465.~        6. Muley T, Fetz TH, Dienemann H, Hoffmann H, Herth FJ, Meister M, et al. Tumor volume and~          tumor marker index based on CYFRA 21-1 and CEA are strong prognostic factors in~          operated early stage NSCLC. Lung Cancer. 2008 Jun;60(3):408-415.~        7. Pine SR, Mechanic LE, Enewold L, Chaturvedi AK, Katki HA, Zheng YL, et al. Increased~          levels of circulating interleukin 6, interleukin 8, C-reactive protein, and risk of~          lung cancer. J Natl Cancer Inst. 2011 Jul 20;103(14):1112-1122.~   "
85646|NCT01936558|"~     With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding~     normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each~     subject using the techniques of fMRI and meridian response.~   "
85647|NCT01936545|"~     Postoperative pulmonary complications are not uncommon after liver transplantation. They can~     not only prolong the stay in intensive care unit and in hospital but also increase the~     morbidity and mortality rate. The underlying mechanisms are multifactorial, however,~     oxidative stress following hepatic ischemia reperfusion and the ensuing pulmonary leukocyte~     infiltration play an important part in the pulmonary complications. Various drugs and~     methods such as ischemic preconditioning have been used to lessen the production of~     oxidative free radicals following hepatic ischemia reperfusion. The choice of different~     anesthetic agents could aslo change the degree of production of oxygen species and~     antioxidant capacity during the operation.~      Volatile and intravenous anesthetic agents can decrease oxidative injuries through different~     mechanisms, however, which is better in preventing the pulmonary leukocyte infiltration is~     still unknown.~      We attempt the compare the oxidative stress and cytokine level in liver transplant~     recipients under desflurane or propofol anesthesia to evaluate which kind of anesthetic~     agent is better in this kind of surgery.~   "
85648|NCT01936532|"~     This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of~     MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed~     multiple myeloma. The patient population will consist of adult men and women younger than 66~     years, who have a confirmed diagnosis of MM who meet eligibility criteria.~      Following the screening period, patients will be enrolled and treated then, they will~     receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After~     Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase~     (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance~     therapy (start 1 month after the last cycle of consolidation) during 12 months.~   "
85649|NCT01936519|"~     This study will examine the renal sparing impact of implementing a strategy of conversion to~     everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post~     liver transplant~   "
85655|NCT01936441|"~     Self-reported sleep complaints are common in peri- and postmenopausal women and have been~     identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial~     of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related~     Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical~     trial. The target population will include women in general good health, aged 40-65 years,~     who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We~     plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half~     of the women will be randomly assigned to receive the behavioral intervention and half to~     receive the behavioral control.~      The intervention arm participants will receive 6 sessions of a telephone-based,~     cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art~     methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I).~     The control arm participants will receive telephone-based Menopause Education Control (MEC)~     that includes elements of sleep hygiene. Assessments for both groups will be collected at~     baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.~      The inclusion/exclusion criteria are designed to target broadly those midlife women who have~     menopause-related sleep disturbance and also report being bothered by vasomotor symptoms.~     This target population defines the clinical population seeking treatment for relief of~     menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to~     exclude women with significant medical problems likely to account for their sleep problems~     (instead of menopause), or likely to interfere with their ability to participate in the~     intervention. We include women taking hormone therapy or other medication who meet these~     criteria because they are part of the population seeking clinical care for relief of sleep~     disturbances.~      Our primary objective is to develop an intervention that is generalizable to the greatest~     number of women and maximally translatable into real-world primary care practice.~   "
85656|NCT01936428|"~     The purpose of this study is to evaluate (thanks to analysed interview) the perception of~     palliative care by relatives of patients treated in oncology.~   "
85657|NCT01936415|"~     In a prospective randomised study two uncemented tibial components with different coating~     (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal~     coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component~     coatings are designed to provide excellent conditions for bone ingrowth.~      The differences between the two tibial components are evaluated by measurements of migration~     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the~     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry~     (DEXA).~   "
85658|NCT01936402|"~     Unlikely the other element for high quality chest compression during Cardiopulmonary~     resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth~     (CCD) is influenced by surface on which the patient is placed, especially in hospital. For~     solving this problem, to place the patient on rigid surface, use a backboard that might~     decrease the mattress compression, receive a feedback that reflects the mattress compression~     depth (MCD) using dual accelerometer or magnetic sensor have been proposed. As the other~     solution, we hypothesized that training of 6-7cm CCD for healthcare providers improve~     accurate CCD during cardiopulmonary resuscitation when manikin is placed on mattress in~     hospital.~   "
85659|NCT01936389|"~     Glaucoma is the world's the second leading cause of irreversible blindness. The World Health~     Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million~     people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk~     factor for the development and progression of glaucomatous optic neuropathy. Medical therapy~     is aimed at lowering IOP in order to prevent or slow progression.~      Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma,~     affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of~     patients have disease in only one eye on clinical examination; however, XFS is detectable in~     the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the~     cardiovascular and cerebrovascular systems.~      Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma.~     Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal~     IOP fluctuation, greater visual field loss and optic nerve head damage at the time of~     diagnosis, poorer response to medications, more rapid visual field progression and more~     frequent need for surgery.~      Because you meet eligibility criteria for our study, we ask for your consent to participate~     in the study described below. In brief, you will be taking an investigational drug~     (AR-12286, rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug~     is currently being tested in patients with primary open-angle glaucoma, but not yet in~     glaucoma in exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the~     mechanism of action of rho-kinase inhibitors, there is reason to think it would be more~     effective in eyes with XFS and glaucoma than in primary open-angle glaucoma (ordinary~     glaucoma). There will be a baseline and study day 1 visit, week 1 visit, month 1 and 3~     visit, week 13 visit, month 6 visit and a week 25 visit; for a total of 7 office visits.~   "
85660|NCT01936376|"~     The project is designed to test new biomarkers that are more sensitive than the current~     standard in detecting injury to the proximal kidney tubule and will establish better~     criteria for when kidney safety concerns may halt further testing of a drug in humans.~   "
85661|NCT01936363|"~     This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating~     the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib~     placebo administered once per day compared to pimasertib administered twice per day plus~     SAR245409 placebo administered once per day in subjects with previously treated unresectable~     low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal~     tumors.~   "
85662|NCT01936350|"~     Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac~     magnetic resonance for ventricular analyses and after this first exam they will be~     randomized to placebo or Sildenafil. After one hour drug intake they will undergo another~     cardiac magnetic resonance to evaluate the drug impact on right and left ventricular~     function.~   "
85663|NCT01936337|"~     In this study, the safety, tolerability and efficacy of DLX105 administered topically onto~     the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.~   "
85664|NCT01936324|"~     The purpose of this study is to determine the safety and tolerability of DRM01B topical in~     healthy volunteers. Following review of safety data, this study will determine the safety,~     tolerability and preliminary efficacy of DRM01B Topical Gel in subjects with acne vulgaris~   "
85665|NCT01936311|"~     The purpose of this study is to test whether having patients identify a self-management goal~     (health goal), prior to a visit with their primary care provider, leads to health behavior~     improvement over six weeks.~   "
85666|NCT01936298|"~     The investigators evaluate the effectiveness of the application of continuous passive motion~     device for hand rehabilitation in two classes of patients: with a residual active motion and~     without a residual active motion.~   "
85667|NCT01936285|"~     -  There is evidence that inflammatory processes may play detrimental role during the~          acute phase of myocardial infarction~        -  The hypothesis of this study is that colchicine, by its anti-inflammatory action, may~          lead to reduction in infarct size, when administered during the acute phase of~          myocardial infarction~   "
85874|NCT01933347|"~     The purpose of this study is to evaluate the disease control rate (DCR) of gefitinib as~     third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation~     patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R~     positive mutation and tumor progression after the second-line chemotherapy~   "
85668|NCT01936272|"~     World over, infants with hydrocephalus are mainly treated using a shunt, which is a device~     made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is~     required to insert a shunt into the brain and the abdomen. In recent years, we have~     developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid~     Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of~     these procedures in children less than six months of age who have hydrocephalus as the~     result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most~     common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more~     detail to measure brain growth and development. Children in the study will have special~     testing to measure developmental progress as well as special imaging to evaluate the~     progress of their brain growth.~   "
85669|NCT01936246|"~     To date, few studies have been done regarding nutrition supplementation in infants with~     brain injury. Therefore, the investigators are proposing to study the effects of protein~     supplementation in this group of babies. The investigators will recruit 24 infants with~     brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted~     to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study.~     Upon diagnosis, the investigators will obtain consent from the parents for participation in~     the study, then randomly assign the baby to one of two groups - an increased protein group~     and a control group. Both groups of infants will be monitored to ensure no adverse effects~     occur due to the supplementation.~      Protein supplementation will continue for the first 12 months of age. Growth parameters,~     such as weight, length, and head circumference, will be measured while the infant is the~     NICU. Head circumference will be measured in the investigators outpatient clinic at three,~     six, and 12 months of age. At 18-22 months, the infants will be tested for~     neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators~     hypothesize that infants who receive the additional protein will demonstrate increased head~     growth and improved neurodevelopmental outcomes.~   "
85670|NCT01936233|"~     Sustained chronic hepatitis B virus inflammation is a major cause of liver cancer occurrence~     and development. Antiviral treatment can block the persistent infection. Aspirin can inhibit~     platelet function and CD8 + T cell mediated liver cell necrosis and inflammation. Aspirin~     also can inhibit liver cancer cells metastasis through inhibit COX2.~   "
85671|NCT01936220|"~     Objective: to evaluate the effectiveness of specialised and sustained intervention with or~     without parent groups during the initial phase of schizophrenia or related disorders on~     relapse prevention~      Methods: A three conditions randomized trial with a duration of five years~      Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic~     episode of schizophrenia or related disorder~      Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent~     groups (ST+P) and Treatment As Usual (TAU).~      Outcome-measures: cumulative relapse rates and time to first relapse after first remission.~     Secondary outcome measure: social functioning.~      Statistical analysis: cumulative relapse rates using life-table methods. The effect of the~     three interventions on time to first relapse after remission will be compared using Cox~     regression analysing intention to treat (ITT) grouping.~   "
85672|NCT01936207|"~     IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a~     multicentre, prospective, observational,14-day inception cohort study designed and conducted~     by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of~     ICU-SARI, document commonly used treatment and monitoring strategies, measure current~     outcomes and identify potential topics for multidisciplinary studies ranging from~     interventional clinical trials to fundamental mechanisms of disease.~      The purpose of this study is to answer the following questions:~      What is the frequency and disease burden of SARI for ICU's worldwide? What are the~     aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the~     outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the~     aetiology of the disease? Can we identify high-risk categories of SARI that could constitute~     a defined population for an interventional study?~   "
85673|NCT01936194|"~     This clinical trial will study the effects of PUFA supplementation during pregnancy and~     lactation period on fatty acid composition in human milk and plasma of the mothers and the~     clinical outcome of atopic dermatitis in infants at increased risk.~   "
85674|NCT01935960|"~     This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in~     preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from~     forming in healthy volunteers.~   "
85675|NCT01935947|"~     This randomized phase II trial studies how well azacitidine and entinostat before~     chemotherapy works in treating patients with non-small cell lung cancer that has spread to~     other places in the body. Drugs used in chemotherapy, such as azacitidine, irinotecan~     hydrochloride, gemcitabine hydrochloride, docetaxel, and pemetrexed disodium, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Entinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and~     entinostat before chemotherapy may work better in treating patients with non-small cell lung~     cancer.~   "
85676|NCT01935934|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     endometrial cancer that has come back (recurrent) or has spread to other places in the body~     (metastatic). Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
85677|NCT01935921|"~     This phase Ib trial studies the side effects and best dose of ipilimumab when given together~     with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with~     previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as~     ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain~     cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~     Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.~   "
85678|NCT01935908|"~     The purpose of this study is to determine the feasibility of prospectively enrolling and~     randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam~     or not to receive levetiracetam, and documenting in-hospital and follow-up clinical~     variables.~   "
85679|NCT01935895|"~     Introduction: Daily stress levels of population are increasing over the last decades.~     Frequent spouse to stress is considered an important risk factor for development of~     cardiovascular diseases. Other well documented risk factor for cardiovascular diseases is~     systemic hypertension which, in turn, has been related to elevated blood pressure reactivity~     (BPR) to stress. The exacerbated BPR may suggest a poor autonomic modulation due to an~     elevated sympathetic tone, condition that has been associated with medium to long-term~     cardiovascular complications. Also, some reports have demonstrated that individuals~     hyper-reactive to stress chronically increase their risk for psychological disorders such as~     anxiety, irritability and frustration. These feelings are associated to increased~     sympathetic tone induced chronic elevation in BP. Although the hemodynamic benefits of~     aerobic and resistance exercises had been documented in a variety of reports5, the acute~     effects of the aforementioned exercise modes combined in a circuit method on post-exercise~     BP, including the responses to cardiovascular stressor test need further investigations.~     Objective: To investigate the blood pressure (BP) responses to cardiovascular stressor test~     after a combined exercise circuit session at moderate intensity. Methods: Twenty individuals~     (10male/10fem; 33.4±6.9years; 70.2±15.8kg; 170.4±11.5cm; 22.3±6.8 %body fat) volunteered to~     randomly perform on different days: 1) Exercise session consisting of 3-laps in a circuit~     model in the following sequence: knee extension, bench press, knee flexion, rowing in the~     prone, squat, shoulder press and 5-min of aerobic exercise at 75-85% of age-predicted~     maximum heart rate and/or 13 in the Borg-Scale [6-20]. The sets of resistance exercise were~     composed by 15 repetitions with ~50% of one repetition maximum test and; 2) a control~     session without exercise. The systolic blood pressure (SBP) and diastolic blood pressure~     (DBP) were measured at resting and during 1h of recovery in both experimental sessions.~     After that, blood pressure reactivity (BPR) was evaluated using the Cold Pressor Test (a~     test with hand in the cold water during one minute). The hypotheses are that after doing the~     exercise session occur attenuation of blood pressure increase during the Cold Pressor Test~     compared to sitting without exercise (control session).~   "
85680|NCT01935882|"~     Primaquine (PQ) is currently the only available drug that can clear mature transmission~     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist~     after artemisinin-combination therapy. However, there are safety concerns about the use of~     PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate~     dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD~     deficient individuals; this side-effect is dose dependent. There are indications that a~     lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious~     dose for gametocyte clearance is currently unknown. Recently, the World Health Organization~     changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no~     direct evidence on the extent to which (low dose) PQ prevents malaria transmission to~     mosquitoes and what the lowest efficacious dose is.~      In the current study we aim to identify the lowest efficacious dose of PQ in individuals~     with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme~     function will be randomized to treatment with artemether-lumefantrine alone or in~     combination with low doses of PQ. All enrolled individuals will receive a full three-day~     course of AL, and will be randomized to receive a dose of primaquine or placebo with their~     fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up,~     measured by molecular methods. For a subset of participants with patent gametocytes,~     primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays~   "
85681|NCT01935869|"~     The purpose of this study is to determine the skin irritation potential and sensitisation~     potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy~     subjects.~   "
85682|NCT01935856|"~     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after~     single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients~     receiving hemodialysis~   "
85683|NCT01935843|"~     RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous T cells may make the body build immune response to kill cancer~     cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric~     cancer, hepatic carcinoma, endometrial cancer and ovary cancer.~   "
85684|NCT01935830|"~     The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz~     and ritonavir on human brain LAAM disposition in vivo.~   "
85685|NCT01935817|"~     Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting~     mainly from the complications of cirrhosis and HCC.~      The investigators' aim will be to evaluate the impact on of supplementation with a new~     pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis~     C treated with Pegylated-Interferon-α2b plus Ribavirin.~   "
85686|NCT01935804|"~     The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health~     including bone mineral density, bone turnover markers, and osteocyte biomarker in patients~     with type 2 diabetes (T2DM).~   "
85687|NCT01935791|"~     The purpose of this study is to determine what can activate brown adipose tissue (BAT).~   "
85688|NCT01935778|"~     The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC~     (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are~     currently accepted as a standard therapy among the AGC patients who were performed~     gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and~     IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as~     one of the best treatments for IIB and IV(M0) stage AGC patients who were performed~     gastrectomy.~   "
85689|NCT01935765|"~     Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due~     to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in~     some studies diabetes status. Few data are available for type 1 diabetes but suggest that~     the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of~     sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and~     a control group matched by age, gender and body mass index. The secondary objective is to~     determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed~     by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the~     diabetic group.~   "
85690|NCT01935752|"~     Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial~     disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown~     origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of~     narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery,~     arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several~     factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order~     to progress into identifying possible causative mechanisms of the disease, we design a~     pathophysiology study destined to assess endothelial function in patients with fibromuscular~     dysplasia and to identify possible plasmatic biomarkers of the disease.~   "
85692|NCT01935726|"~     As the name states, contact registries securely store contact information from groups of~     reasonably well-characterized patients (or primary supporters/caregivers) who are interested~     in being informed about ongoing or future research opportunities. Pulmonary fibrosis (PF) is~     a condition for which effective therapies have remained elusive, making drug trials and~     interventional research studies a mainstay in the PF arena over the last decade and for the~     foreseeable future. A PF Contact Registry will be a conduit to collect, analyze, and~     disseminate de-identified, group-level data on the clinical phenotypes of PF patients and~     will house contact information from patients who wish to be informed about research~     opportunities for which they may qualify. Data contained in the Registry will help inform~     research hypotheses and guide investigators as they develop research protocols by providing~     them with numbers of potential subjects who meet particular inclusion/exclusion criteria.~   "
85693|NCT01935713|"~     The overall aim of the current study is to determine if the use of nicotine containing~     products by caregivers who smoke and who are not interested in quitting, is effective in~     reducing children's secondhand smoke exposure.~   "
85694|NCT01935700|"~     This trial is to evaluate the potential of colchicine for the palliative management of~     hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the~     Department of Health R.O.C. approved doses and methods of administration.~   "
85695|NCT01935687|"~     The purpose of this study is to validate an instrumented wheel such as a new biomedical~     device. The physicians will compare this instrumented wheel with another instrumentation~     Ergometer roller, each patient will try the both instrumentations, physical and~     physiological parameters will be measured.~      The increase rate of radial power during the cardiac stress test may be more important when~     the physicians use the instrumented wheel.~   "
85696|NCT01935674|"~     To compare the effect of rosuvastatin to protease inhibitor switching on fasting total~     cholesterol over 12 weeks.~   "
85697|NCT01935661|"~     β-thalassemia syndromes are a group of hereditary disorders characterized by a genetic~     deficiency in the synthesis of beta-globin chains.~      In recent studies done in β-thalassemia major patients abnormal iron deposition was evident~     using MRI in brain structures, cortex, putamen, and caudate nucleus . In most of the cases~     the neurological involvement is subclinical. Cognitive functioning was evaluated in beta~     thalassemia major, compared with healthy controls, using a neuropsychological battery~     including tests of abstract reasoning, attention, executive functions, language,~     constructional/visuospatial skills, and memory. Patients with beta thalassemia major, in~     particular those showing signs of hemosiderosis, had significantly impaired function in all~     neuropsychological tests. There was no relationship between cognitive performances and signs~     of deferoxamine toxicity, deferoxamine dosage, and levels of hemoglobin and ferritin.~     Event-related potentials (ERPs) are one of the most informative and dynamic methods of~     monitoring the information stream in the living brain. ERPs are linked in time with a~     physical or mental event, and are typically extracted from the scalp-recorded~     electroencephalogram (EEG) by means of signal averaging.~      ERPs have been used in the assessment of cognitive function in several disorders, including~     anemia and iron deficiency anemia. However, literature regarding cognitive function and ERP~     activity in thalassemia patients is extremely limited, especially in adults.~      The purpose of this study is to evaluate the cognitive and brain function in a group of 60~     thalassemia patients and compare the results to healthy controls.~   "
85698|NCT01935648|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee~     replacement surgery. The investigators plan to measure these levels by testing blood samples~     taken over a timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
85699|NCT01935635|"~     The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With~     Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic~     hepatitis B patients~   "
85700|NCT01935622|"~     Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of~     systemic inflammation.~      Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful~     anti-inflammatory effects.~      In this study we plan to determine the effects of Doxycycline in patients with stable heart~     failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and~     ventilator efficiency measured with a cardiopulmonary test.~   "
85701|NCT01935609|"~     1. To evaluate the efficacy of a structured outpatient couples intervention program~          (Therapeutic Couples Intervention, TCI) on couples' marital quality after acquired~          brain injury (ABI).~        2. To assess the impact of the TCI on the emotional well-being of persons with ABI and~          their partners.~        3. To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by~          partners of persons with ABI.~        4. To examine the extent to which treatment benefits for survivors and their caregiving~          partners are sustained in the longer-term.~   "
85702|NCT01935596|"~     This is a Biomedical Research, prospective, randomized, double blind, controlled~     monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5%~     levobupivacaine and ropivacaine 0.5%.~   "
85703|NCT01935583|"~     1. To evaluate the short and longer-term efficacy of a structured outpatient intervention~          program (The Resilience and Adjustment Intervention, RAI) to improve survivors'~          resilience.~        2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.~        3. To evaluate the impact of the intervention on abilities including problem solving,~          communication, and stress management.~        4. To examine the extent to which treatment benefits are sustained in the longer-term.~   "
85704|NCT01935570|"~     This clinical study is composed of two steps. The first step aims at validating the~     pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.~      According to these results and if this pharmacokinetic approach is validated, the second~     step will set up. The second phase aims at comparing the relative bioavailability of~     magnesium administrated by two different drug formulations: ChronoMag Smart Tablet® (two~     tablets50mg) versus Mag2® (three tablets100mg).~   "
85705|NCT01935557|"~     Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing~     during the procedure is important.~      Randomized comparison of continuous and intermittent heparin infusion during catheter~     ablation of Atrial Fibrillation.~   "
85706|NCT01935544|"~     Botulinum toxin injections are an effective treatment of limb spasticity after stroke.~     Different tracking techniques are used to locate a proper injection spot. Palpatory~     technique is barely effective and induces a high risk of error. Localization by electro~     stimulation is frequently used in adults, but often requires multiple painful repositioning~     of the needle. Ultrasound tracking is sometimes used in children but not much in adults.~      The advantages of ultrasound-guided botulinum toxin injections are a painless localization~     and greater injection accuracy. Safety is therefore enhanced since intravascular injection~     is easily avoided.~      The few existing publications on the subject are essentially case reports. Few studies have~     focused on comparing different injection techniques and so far, no well-conducted study has~     highlighted superior efficiency of ultrasound-guided injections.~   "
85707|NCT01935531|"~     The rationale of this study is to investigate the effects of topical diclofenac on tumor~     metabolism in the treatment of actinic keratoses in immunocompetent and immunocompromised~     patients.~      Study hypothesis is that topical diclofenac lowers lactate level in skin biopsies of actinic~     keratoses. Planned number of patients is 38.~      This study is a monocenter study investigating the effects of 3% diclofenac in 2.5%~     hyaluronic acid gel on tumor metabolism in the treatment of actinic keratoses. Treatment~     duration is 3 months. Skin biopsies will be obtained before treatment, at the end of the~     treatment and four weeks after the treatment. Control biopsies at visit 1 and 3 are~     performed in healthy, sun damaged and untreated skin. Evaluation of efficacy will be~     performed at the end of the treatment and four weeks after the treatment.~      Duration of treatment is 3 months (±4 weeks). Approximately 0,5g Solaraze® 3% gel is applied~     on a 5cm x 5cm lesion. Solaraze® 3% gel is applied twice daily on the study lesions.~   "
85708|NCT01935518|"~     This study will examine whether fasudil is effective and safe in treating patients with~     amyotrophic lateral sclerosis (ALS).~   "
85709|NCT01935505|"~     This is a observation non-randomized control trial, and a follow-up study on the smoking~     cessation.~   "
85710|NCT01935492|"~     An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8~     cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in~     combination with bevacizumab, and second line treatment of patients with HER2/neu negative,~     incurable, metastatic or unresectable locally advanced breast cancer.~   "
85711|NCT01935479|"~     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability~     of AK159 administered to healthy postmenopausal women.~   "
85712|NCT01935466|"~     Pioglitazone, an agonist of the peroxisome-proliferator-activated receptor (PPAR), is a~     relatively new oral anti-hyperglycemic drug. Since its first approval in the USA in 1999, a~     potential link with bladder cancer has been a subject of debate. US Food and Drug~     Administration (FDA) in September, 2010 and European Medicines Agency in July, 2011 issued~     an alert about a potential relation between the occurrence of bladder cancer and the~     prescription of pioglitazone, based on the data from various studies. France banned its use~     in July 2011.~      Recently Pioglitazone was banned from India without any evidence of increased bladder cancer~     in our population. With this background, we plan to study the risk of bladder cancer in male~     type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared~     to never-users of pioglitazone in a retrospective cohort design and provide the first data~     from India to the policy makers regarding the purported risk in our ethnicity and~     geographical area.~   "
85713|NCT01935453|"~     The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds~     of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.~   "
85714|NCT01935440|"~     The goal of this study is to conduct an HIV prevention intervention to train HIV~     seropositive drug users to be peer health educators.~   "
85715|NCT01935427|"~     This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI~     system.~      Healthy human subjects will undergo progressive reduction in central blood volume to the~     point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure~     (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as~     sweating, nausea, or dizziness) to validate the following hypotheses:~      The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend~     stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading,~     instead it is an actual CRI trend value that does not require calibration or being placed~     during normal physiological conditions.~   "
85716|NCT01935414|"~     This study hypothesises that the geko™ device is more efficient than TEDS in preventing the~     formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.~   "
85717|NCT01935401|"~     The purpose of this study will be to replicate previous findings of deficits in prefrontal~     activation during response inhibition tasks in bulimia nervosa and extend these findings by~     demonstrating similar deficiencies in activity during a functional behavioral task that~     requires the inhibition of eating. Findings from this study will potentially help to~     elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and~     prevention efforts.~   "
85718|NCT01935388|"~     Many hospitals employ a common canister inhaler protocol in patients that do not require~     mechanical ventilator support. Common canister refers to a single inhaler paired with~     standardized cleaning methods for use on more than one patient. Small reports suggest that~     this method does not pose an increased infectious risk and is associated with significant~     cost savings.~      Common canister protocols offer a solution to the discordance between inhaler sizes and~     average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug~     for several days to weeks of daily use. However, the average length of stay for most~     inpatients is only several days. Therefore, most inpatients do not use all of the canister~     contents, an unused resource that is potentially wasted.~      The common canister approach has not been previously described in mechanically ventilated~     patients (people requiring intensive care unit admission on breathing machines). This study~     aims to assess the safety of common canister utilization by assessment and comparison of~     infection rates in the study and control group.~   "
85875|NCT01933334|"~     PSSc-001 (LOTUSS)~      This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and~     tolerability study of pirfenidone in participants with systemic sclerosis−related~     interstitial lung disease (SSc-ILD).~   "
85719|NCT01935375|"~     HYPOTHESES:~      The hypotheses are that:~        1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone~          to women with postpartum depression~        2. women receiving interpersonal psychotherapy will have less symptoms of postpartum~          depression, better functioning, better bonding with their babies, and better~          relationships with their partners~        3. women with postpartum depression will be more satisfied with their care than women in~          the group that was referred to a mental health center.~   "
85720|NCT01935362|"~     Cardiovascular disease (CVD) is the leading cause of deaths in the Western world.~     Established risk factors include high LDL cholesterol, high blood pressure and diabetes.~     Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed.~     Several different measurements can be used to determine blood vessel health; such as blood~     pressure (BP), and newer techniques which measure blood flow through the arteries after a~     blood pressure cuff restricts blood flow for a few minutes in one arm.~      Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk~     of CVD. From the previous studies, there is strong evidence that orange juice and citrus~     foods which have higher amount of specific citrus flavonoids improved cardiovascular risk~     factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the~     colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed~     into the blood they are modification by liver enzymes before they are excreted in the urine.~     A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere~     from 0-57% of the dose. Variation in the potential health effect may reflect the level of~     the citrus flavonoid absorbed, and this is not often considered in human studies.~      This study is a 4-week double-blinded, randomized, cross-over intervention trial using a~     commercially-available orange juice supplement and a placebo control. The aims of the study~     are to determine whether orange juice supplements reduce blood pressure and improve blood~     vessel health after 4 weeks. Furthermore, to determine if there is a relationship between~     absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or~     blood vessel health.~      The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for~     12 weeks. On each study day they will have their weight, height, waist circumference, and~     blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek~     Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in~     fingertips will be monitored before and after reducing blood flow in your forearm using a~     blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24~     hr on each of the study days, and to consume the supplements provided daily for two sets of~     4 weeks (there will be 4 weeks in the middle without any supplements).~      An improvement in blood pressure and/or blood flow will provide evidence that blood vessel~     health has improved through short-term (4 week) use of a citrus flavonoid supplement~   "
85721|NCT01935349|"~     Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top~     10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority~     (HA) has initiated service improvement through introducing the patient empowerment programme~     (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC~     is an essential part of the programme in order to inform future policy. The Family Medicine~     Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out~     the evaluation of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the PEP programme is achieved. Each PEP participating clinic and~     non-government organization (NGO) will be invited to complete a structured evaluation~     questionnaire. The data of all patients who have enrolled into the PEP for more than one~     year will be included in the evaluation on the process and outcomes of care. A hundred and~     thirty participants will be followed up by telephone to evaluate the effect of the programme~     in quality of life (QOL), patient enablement, and global rating of change in health~     condition at baseline and 6 months after enrolment. Data on the process of care will be~     retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the~     proportion of participants who have received the planned process of care and achieved the~     target HbA1c and blood pressure levels.~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12~     months will assessed by paired sample t-test. The audit cycle will be repeated annually over~     a period of 5 years.~      Results: The QOC of the PEP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified. Conclusion: The results of this study will~     provide empirical evidence on whether the HA's PEP programme can enhance QOC for patients~     with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide~     service planning and policy decision making.~   "
85722|NCT01935336|"~     This phase II trial studies how well ponatinib hydrochloride works in treating patients with~     stage III-IV lung cancer. Ponatinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
85723|NCT01935323|"~     6-week, single site, two parallel arm, randomized, controlled trial comparing the~     effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate~     Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in~     overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce~     similar metabolic and cardiovascular adaptations typically associated with MIT.~   "
85724|NCT01935310|"~     Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in~     pre malignant and malignant lesions caused by UV radiation it reverses histopathological~     changes associated with the photoaging skin.~      This is an experimental exploratory study. It included 17 patients. The patients were~     diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to~     participate in the study. Patients were treated with imiquimod 5% topically, for a time~     period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4~     weeks after completing the treatment. Adverse effects, adherence to therapy and patients'~     satisfaction were measured.~      Clinical and histological parameters of photoaging were studied at baseline and after~     treatment. After completion of treatment with imiquimod, the final clinical evaluation was~     compared to the initial one.~   "
85725|NCT01935297|"~     This pilot study will evaluate the effect of a rehabilitative exercise training on exercise~     capacity in patients after percutaneous aortic valve replacement. It will additionally~     evaluate the safety of such an approach and the effect on life quality. We hypothesize that~     regular structured exercise improves exercise capacity in these patients beyond the sole~     effect of the valve procedure.~   "
85726|NCT01935284|"~     To assess the interchangeability and agreement between measurements from three blood gas~     syringes for the collection of blood for the analysis of multiple analytes as measured by~     differing manufacturers' multi-parameter analyzers.~   "
85727|NCT01935271|"~     The ability of older adults to improve their muscle strength through exercise training~     appears related to how well their immune system functions. Thus, a nutritional supplement~     which improves immune function could theoretically boost strength gained for older adults~     from exercise. The purpose of this pilot study is to determine if a nutritional supplement~     has any effect on immune function.~      Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to~     consume supplement or placebo for four weeks. After two weeks of consumption, subjects will~     be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from~     each subject before and after vaccination to determine the effects of the supplement on~     immune response to vaccination. Additionally, subjects will undergo blood draw and muscle~     biopsy before and after two weeks of supplementation to determine the effects of~     supplementation on other measures of immune function (e.g. cytokine and growth factor~     levels). This is an important issue due to the serious health consequences associated with~     muscle loss in older adults and the need for improved strategies for rehabilitation.~   "
85728|NCT01935258|"~     Medically unexplained symptoms (MUS) are a common and important problem in primary care.~     Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their~     symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful~     tests, referrals and treatment. Evidence indicate that specific interventions for patients~     with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited~     help. According to experts in this field a multi-component approach is most helpful for~     these patients.~      This pilot trial aims to test the systematic identification of eligible patients, to assess~     the acceptability of the intervention and to estimate potential treatment effects for a~     larger trial.~      It's a randomised pilot study consisting of patients with MUS in primary care. Patients will~     be randomized to intervention (usual care and additional psychosomatic therapy) or control~     condition (usual care alone). Patients will be followed for one year.~      Participants are patients consulting their GP more than once with MUS and in which the GP~     presumes that psychosocial distress is an underlying cause.~      The intervention is the psychosomatic therapy delivered by a psychosomatic therapist,~     consists of a combination of information and education, relaxation therapy and mindfulness,~     cognitive approaches and activating therapy. This multi-component approach is captured into~     a protocol in which therapists are able to modify the treatment in order to deliver a~     tailor-made treatment for patients with MUS.~      Primary outcome measures are: the number of patients identified and recruited, perceived~     symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated~     symptoms of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional~     Symptom Questionnaire). Other primary outcome measures are the time needed to include the~     eligible patients, the number of withdrawals in the intervention and control group,~     compliance in the therapy group and the number of patients who complete the questionnaires.~      Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation~     List), physical and mental health status and quality of life (SF-36), and level of~     functioning (MAF: measure of general functioning). Patient satisfaction with the received~     therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the~     Cost Diary for medical consumption.~   "
85729|NCT01935245|"~     Rationale:~      Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal~     extracorporeal circulation system (minimal-ECC) has several advantages compared with~     conventional ECC amongst less platelet activation. Platelet function can be analysed with~     thromboelastography (TEG) and multiple electrode aggregometry (MEA).~      Objective:~      The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in~     coronary artery bypass grafting (CABG) analysed with TEG and MEA~      Study design:~      Single center, prospective, randomized, pilot study~      Study population:~      Group 1:~      20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic~     acid and discontinued the use of clopidogrel minimal 5 days preoperative.~      Group 2:~      20 patients undergoing CABG using conventional ECC. Patients continued the use of~     acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.~      Intervention:~      Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC~      Main study parameters/endpoints:~        1. Results of TEG and MEA, see detailed description~        2. Per operative blood loss and total blood loss 24 hours after CABG~        3. Total amount of transfused platelet units during CABG and 24 hours after CABG~   "
85730|NCT01935232|"~     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture~     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are~     diagnosed only after a fracture. We expect with our aging population to see a significant~     increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic~     patients are not diagnosed and do not receive treatment for their condition.~      This research plan describes a study for clinical validation of the novel ultrasound device~     (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated~     in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n~     = 341 in total). Significant and good correlation was observed between Density Index (DI)~     determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 -~     0.70). In addition, with determination of 90% sensitivity and specificity thresholds,~     significant number (65-75%) of patients could be diagnosed without additional verification~     with DXA.~      For validation of the technique in US population, our study plan is presented for~     determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex,~     lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and~     140 men. The study will be carried out at the HealthEast Osteoporosis Care service in~     Woodbury, MN.~        1. To investigate the capability of DI for prediction of proximal femur and lumbar spine~          BMD;~        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status~          with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis~          is 20%) post-menopausal females (50-90 years);~        3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;~        4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index~          in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or~          low bone mass. Determine diagnostic thresholds for DI in men.~   "
85731|NCT01935219|"~     The objective of this study is to assess the effectiveness of an intervention to address~     both executive function and processing speed changes that contribute to poor driving~     performance in adults with Mild Cognitive Impairment (MCI).~      Our hypotheses are that the study intervention will improve performance on a driving~     simulator and will improve (i) executive function, specifically attention and planning, (ii)~     useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle~     crashes and driving infractions.~   "
85732|NCT01935206|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization.~      In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate~     secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim~     therefore to show that latent sensitization is present in humans and is modulated by~     endogenous opioids.~   "
85733|NCT01935193|"~     The aim of the study is assessing the prevalence of aspirin resistance in a cohort of~     diabetic patients. Those found resistant has been undergone pharmacological tests using~     different drug formulations to investigate the reversibility of aspirin resistance.~   "
85749|NCT01934972|"~     Individuals with bipolar suffer from problems in basic cognitive skills such as memory and~     concentration. Unfortunately, there are no current treatments that have been shown to~     improve cognitive skills among individuals with bipolar disorder.~      Computerized cognitive remediation (CR) is a treatment that has been shown to improve~     cognitive skills among individuals with serious mental illnesses other than bipolar~     disorder, such as schizophrenia. This treatment involves completing a series of activities~     on a computer that have been shown to improve cognitive skills.~      D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.~     Recent studies have suggested that this drug may also improve individuals' ability to learn.~     Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the~     benefit that individuals receive from participation in cognitive remediation.~      To test this hypothesis, approximately forty subjects will be randomized to one of two study~     arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the~     benefit that individuals with bipolar disorder receive from participation in cognitive~     remediation.~   "
85876|NCT01933321|"~     Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the~     neurodegenerative process and stops the clinical progression of disease.~   "
85734|NCT01935180|"~     Effectiveness of screening colonoscopy in cancer prevention relies on the detection and~     removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a~     colonoscopy. It has been estimated that two thirds of missed adenomas are located on the~     proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope~     may allow examination of the proximal aspect of colonic folds, and some early studies have~     suggested an increased polyp and adenoma detection using this technology. However, the~     studies have in part substantial methodological limitations (e.g. missing polyp histology,~     single endoscopist study, polyps not removed at the time of detection). Therefore, at this~     point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The~     objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma~     detection.~      The investigators propose a two-center multiple endoscopists randomized controlled trial.~     Patients will be randomized to cap assisted colonoscopy or standard high definition white~     light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached~     to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean~     number of adenoma per patient). The investigators will assess and adjust for possible~     variables that can affect adenoma detection, including withdrawal time and quality of colon~     preparation. As a secondary outcome of interest the investigators will evaluate a possible~     learning curve effect among all endoscopists (a minimum of six) new to this method. In~     addition the investigators will evaluate whether cap assisted endoscopy improves real time~     prediction of polyp histology.~   "
85735|NCT01935167|"~     Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria~     in Patients With Diabetic Nephropathy~   "
85736|NCT01935154|"~     Patients with stage IV or recurrent stage I-III NSCLC with documented disease control~     (objective response or stable disease) within 3 weeks after platinum based 1st line~     chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be~     included.~      The objective of the trial is survival rate at 12 months.~   "
85737|NCT01935141|"~     With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed~     in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could~     be done with less than the usual 80-120 ml of contrast used. We have developed a method of~     performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most~     patients. The long-term objective of this study is to show that there is no difference in~     the diagnostic efficacy of this low dose 30 ml technique when compared to the more~     traditional full-dose technique.~   "
85738|NCT01935128|"~     The purpose of this study is to evaluate whether conversion to everolimus (Zortress®),~     allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity~     (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant)~     survival (measured by 2-3 year graft survival).~   "
85739|NCT01935115|"~     To determine the effect of ketamine, compared to propofol, when used an an anesthetic agent~     for electroconvulsive therapy (ECT) in the treatment of major depressive disorder (MDD). We~     hypothesize that ketamine, compared to propofol, will improve the the symptoms of MDD when~     used as the anesthetic agent to facilitate ECT. Additionally, we hypothesize the~     dissociative and cardiovascular effects of ketamine will be minimal.~   "
85740|NCT01935102|"~     Although many attempts have been done to identify vascular endothelial growth factor-A~     (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in~     advanced cancer patients, the results are still inconclusive.~      We will conduct a pharmacogenetic study to assess, in a population of metastatic breast~     cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2),~     interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α~     (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with~     first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on~     germline DNA obtained from blood samples and SNPs will be investigated by real-time~     polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR)~     methodology will be applied to investigate the interaction between SNPs.~   "
85741|NCT01935089|"~     We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a~     decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected~     immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm,~     open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects~     (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y~     with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.~      We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV~     reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or~     immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir~     in chronically HIV-infected, immune-reconstituted individuals.~   "
85742|NCT01935076|"~     The purpose of this study is to determine whether placental and umbilical cord blood miRNA~     expression is altered in women with obesity with macrosomic neonates to when compared to~     miRNA expression from control patients.~   "
85750|NCT01934959|"~     Enterocolitis(EC) is the most common and serious postoperative complication of~     Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes~     that, when administered in adequate amounts, confer health benefit to the host.Based on this~     previous knowledge on the beneficial effects of probiotics during pro-inflammatory~     conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics~     could decrease the incidence and severity of Hirschsprung's disease associated~     enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and~     controlled trial to assess whether oral probiotics could decrease the incidence and severity~     of Hirschsprung's disease associated enterocolitis(HAEC).~   "
85751|NCT01934946|"~     Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no~     adequate rehabilitation was given. The aim of the study is to compare the effectiveness of~     different types of post acute rehabilitation care for hip fracture.~   "
85921|NCT01932736|"~     This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and~     when the brain responds to pressure stimulations of the eardrum. The study requires 2~     visits, 1 for screening to determine eligibility and 1 for the fMRI. This study will help to~     understand how the middle ear system is controlled, which may have an impact on how people~     with middle ear disease are treated.~   "
85743|NCT01935063|"~     Chronic pain problems involving the female reproductive system are major health concerns for~     all women. Poorly understood, they entail great personal and financial cost. One such~     condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%.~     Despite its negative impact on psychosexual and relationship satisfaction, there is little~     research examining empirically-tested treatments for afflicted couples. The proposed~     research builds on findings from our work focusing on the impact of relational factors on~     vulvodynia, and our previous research evaluating the efficacy of group cognitive-behavioral~     therapy for this problem. This two-centre randomized clinical trial aims to assess the~     efficacy of a novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in~     comparison to one of the most commonly prescribed first line medical interventions, topical~     lidocaine. Primary research question: Is there a significant difference between the two~     treatments on women's pain during intercourse post-treatment? Secondary research questions~     will assess for significant differences between the two treatments post-treatment and at~     6-month follow-up on multidimensional aspects of pain using the McGill Pain Questionnaire,~     women and partners' sexuality (sexual function and satisfaction), psychological adjustment~     (anxiety, depression, catastrophizing, self-efficacy, attributions, and quality of life),~     relationship factors (partner responses, couple satisfaction, attachment, and communication~     styles), and self-reported improvement and treatment satisfaction. Results of this study~     will improve the health and quality of life of patients with vulvodynia by rigorously~     testing the efficacy of a novel couples treatment.~   "
85744|NCT01935050|"~     The purpose of this project is to develop and pilot-test a guided cognitive-behavioral~     self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will~     pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The~     manual will be revised based on participant feedback. Several feasibility measures regarding~     the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness,~     adherence) will also be assessed. Moreover, preliminary estimates of effect size for this~     guided self-help program will be calculated and used in future research. We hypothesize that~     people with PD will report decreases in depression, anxiety, and negative thoughts and~     improvements in quality life and sleep and that caregivers will report decreases in burden~     after participating in the guided self-help program~   "
85745|NCT01935024|"~     Exercise has been shown to be beneficial for the brain. The investigators would like to test~     this specifically for those diagnosed with Alzheimer's disease. This study will involve 30~     randomized patients to take part in the out-patient exercise program and 30 patients to~     continue with their regular activities over a 6-month period. Once that period is over, half~     of the 30 patients who participated in the outpatient exercise program will continue in the~     program and the other half will be randomized to independently continue to exercise. The~     investigators hypothesize that exercising will benefit the patient by slowing the dementia~     process, improving behavioral symptoms, and decreasing volume loss of certain brain regions.~     Each person will perform personalized exercise regimens, MR imaging and neuropsychological~     tests will be used to measure the benefits of exercise. Ultimately, the hope is that the~     results of this study could be used to facilitate exercise programs for patients. Enrollment~     is completely voluntary and all personal data obtained will remain confidential.~   "
85746|NCT01935011|"~     The stimulation frequency has been found to affect the axial symptoms of freezing of gait~     (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep~     brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz~     worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation~     frequency on another important axial symptom, swallowing dysfunction, has not been studied.~     The investigators hypothesize that stimulation frequency could have similar effect on~     swallowing function.~   "
85747|NCT01934998|"~     The spinocerebellar ataxias (SCAs) are a genetically heterogeneous group of dominantly~     inherited progressive ataxia disorders. More than 30 different gene loci have been~     identified so far. The most common SCAs, which together account for more than half of all~     affected families, are SCA1, SCA2, SCA3, and SCA6. Each of these disorders is caused by a~     translated CAG repeat expansion mutation. SCA1, SCA2, and SCA3 usually have an onset between~     30 and 40, and SCA6 usually begins at the age of 50 to 60. In addition to progressive~     ataxia, SCA1, SCA2, and SCA3 frequently present with additional non-ataxic symptoms,~     including parkinsonism. Carbidopa/levodopa was found to have a good therapeutic effect on~     parkinsonism.~      The SCA6 used to be considered a pure cerebellar disorder. However, a recent large study on~     natural history of SCAs found that patients with SCA6 often had nonataxia symptoms, an~     observation that challenges the view that SCA6 is a purely cerebellar disorder. Parkinsonism~     in SCA6 was rarely reported, except in a case serial, or a small size study in Korean~     patients.~      Dopamine transporter (DAT) is a very reliable dopaminergic neuronal marker. Reduction in DAT~     density detected by I123 SPECT DaTscanTM in the dopaminergic neuron terminal striatum was~     reported in one small size study consisting of eight SCA6 patients in Korea. There was also~     a PET study using different radioligand for DAT in a small group of SCA6 patients in~     Germany, which found sub-clinical change in DAT density in some patients with SCA6.~      There has been no study so far in the US on parkinsonism and other non-ataxia spectrum and~     striatal dopaminergic damage in SCA6, probably because non-ataxia feature of SCA6 hasn't~     received much attention, and also because DaTscanTM hasn't been clinically available in US~     until recently. The only two published studies on SCA6 and DAT were from Korea and Germany,~     which were of small subject size. There has been no treatment available for SCA6 so far.~      Our hypothesis is that parkinsonism and other non-ataxia spectrum and striatal dopaminergic~     neurodegeneration are part of the SCA6 disease spectrum.~   "
85748|NCT01934985|"~     The investigators propose a 4 year prospective, observational study of 40 patients yearly,~     comparing conventional clinically indicated SPECT and PET perfusion with dynamic rest/stress~     MPI studies with coronary angiography, in some cases performed with quantitative coronary~     anatomy and flow as well as quantitative 13N-ammonia PET MPI. Methods will also be assessed~     for their ability to determine myocardial viability by comparing regional wall motion (WM)~     on clinically indicated serial ventriculography, echocardiography or gated SPECT MPI in~     those protocol patients with WM abnormalities who subsequently undergo revascularization.~     Patient studies will begin in the first study year based on those methods already developed~     and integrate new advances as they become evident.~   "
85781|NCT01934556|"~     The purpose of this research study is to determine if a Treat and Extend regimen~     (increasing the time between visits when the disease is stable and not getting worse) of~     Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with~     swelling of the retina from diabetes.~   "
85922|NCT01932723|"~     Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may~     be attributed to the spinal instability resulting from ligament laxity due to hormonal~     change. The purpose of this study was to investigate the effect of functional lumbar~     stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.~   "
85752|NCT01934933|"~     This is a prospective, open-label trial to evaluate efficacy for delaying ossification and~     improving inflammation of celebrex treatment on active ankylosing spondylitis (AS). Subjects~     will be randomly divided into three groups (Enbrel group, Celebrex group and Enbrel plus~     Celebrex group) and receive responsable treatment for 54 weeks. Clinical response~     assessment, laboratory assessment and radiology assessment will be recorded. Primary~     endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of~     Canada (SPARCC) score and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) of~     spine and sacroiliac(SI) joint, as well as the Assessment of SpondyloArthritis International~     Society (ASAS)20 response rate. Secondary Endpoints include ASAS20, ASAS40, ASAS70 and~     ASAS5/6 response rate on each visit and other clinical indexes.~   "
85753|NCT01934920|"~     This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME)~     in diabetic patients that undergo a DME screening exam. The screening exam will consist of~     medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus~     photography~   "
85754|NCT01934907|"~     The hypothesis is that transfusion of washed red blood cell can decrease the complication by~     transfusion.~   "
85755|NCT01934894|"~     This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients~     with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion~     of the study will determine the optimal dose of the cabazitaxel/lapatinib combination to~     administer to patients. After determining the optimal dose, patients will continue treatment~     with cabazitaxel and lapatinib to assess response to treatment with these agents.~   "
85756|NCT01934881|"~     The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's~     disease (PD) is complex work because the parameter setting has not been standardized so far.~     The objective of the present study is to set up a standardized programming algorithm for~     Chinese PD patients treated with bilateral STN DBS.~   "
85757|NCT01934868|"~     The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the~     long term results of prolotherapy are more effective than those of the current conventional~     treatment: epidural steroid injections (ESI). This research will examine the efficacy of~     prolotherapy injections versus epidural steroid injections for the treatment of low back~     pain radiating to the leg. This is a randomized, unblinded study, in which patients seen in~     the principle investigator's pain clinic will be randomly divided to receive treatments from~     either the experimental, prolotherapy group, or the active control, ESI group.~   "
85758|NCT01934855|"~     The main goal of this research is to characterize patient-specific respiration-induced tumor~     and surrogate motion to evaluate the accuracy and effectiveness of the surrogate-based~     motion management strategies currently used in clinics. Specifically, the investigators~     hypothesize that dynamic MRI (Magnetic Resonance Imaging) obtained over a temporal duration~     consistent with radiotherapy treatments will provide spatio-temporal information of both the~     tumor and surrogate, and therefore can serve as a means to assess the quality of the tumor~     motion tracking with the surrogate. To test this hypothesis, the investigators specifically~     propose to 1) track and characterize the tumor and surrogate motion with 4D (4~     dimensional)-MRI and 2) evaluate surrogate-based motion tracking in a cohort of patients~     with thoracic tumors.~      External and internal surrogate-based strategies commonly used in clinics have not been~     appropriately validated. With the increasing adaptation of these surrogate methods for~     motion management, the proposed research addresses these urgent issues in clinical~     radiotherapy while providing a means to achieve patient-specific motion management.~   "
85759|NCT01934842|"~     This study will compare blood collection from the forearm using an investigational device,~     TAP20-C to blood collection from the finger tip. The blood collected from the forearm and~     from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.~   "
85760|NCT01934829|"~     Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma~     (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which~     may have a negative impact on patient quality of life (QoL). Urea-based creams may have a~     prophylactic effect on sorafenib-induced HFSR in HCC patients.~   "
85761|NCT01934816|"~     This study aims to examine the involvement of KATP channels on the microvascular actions of~     the incretin GLP-1 and its analogues in healthy individuals and to determine whether the~     acute oral administration of different KATP channel blockers which are oral medications for~     Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the~     microvascular responses in these individuals.~   "
85762|NCT01934803|"~     This study is a double-blinded randomized controlled trial (RCT) to assess the efficacy of~     zinc supplementation vs. placebo among 250 HIV-infected Russians from the Russia ARCH~     Cohort, who are ART-naive at enrollment and have a recent history of heavy drinking.~   "
85763|NCT01934790|"~     Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and~     experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common~     Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the~     initial course of radium-223 dichloride that led to the discontinuation of treatment. 40~     Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg~     IV every 4 weeks.~      The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit~     every 4 weeks, prior to receiving radium-223 dichloride.~      After the end of treatment visit the subjects will enter the active follow up period.~     Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the~     first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223~     dichloride.~      After the 2 years of active follow-up, subjects will enter the long-term follow-up period~     and will be followed via telephone follow-up at 6-month intervals for late toxicities and~     survival up to 7 years after the last dose of radium-223 dichloride or until death.~      Joint safety reviews will regularly take place to oversee safety of the subjects conducted~     at regular intervals.~      An interim analysis of the safety data will be conducted during the study.~   "
85764|NCT01934777|"~     The purpose of this interventional study is to evaluate the efficacy and tolerability of~     docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with~     well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).~   "
85765|NCT01934764|"~     Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as~     a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g.~     immunoglobulins) leads to the breakage of the immune tolerance and to the formation of~     anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the~     progression and the present of autoimmune disease. In this research the correlation between~     immune response against biotin and the formations of autoimmune disease, will be studied:~      A. Assessment of the possibility that biotin elicit immune response involved in the~     developmental stage of the autoimmune disease.~      B. Assessment of the possibility that anti-biotin antibodies indicate the developmental~     stage of the autoimmune disease and therefore can serve as an disease early stage marker.~      Methods: A. Patient recruitment. Gathering participant's medical record and blood samples.~     B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for~     the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies~     to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated~     self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E.~     Determination of the correlation between biotinilated antibodies or anti-biotin antibodies~     to disease eruption or severance and autoimmune disease.~      Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are~     increased in patients with active autoimmune liver diseases.~      Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin~     antibodies and autoimmune diseases will open new research direction of possible factors that~     cause to autoimmune disease.~      Probable implications to Medicine: Identification of correlations between reaction to~     biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune~     diseases, severity of the disease and personalization of treatment.~   "
85766|NCT01934751|"~     Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use,~     health care utilization if they have immediate and convenient access to pharmacotherapy and~     addiction counselling.~      Summary: This randomized trial will compare two different interventions for 124 alcohol and~     opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health~     Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The~     Delayed Intervention group will receive a card with contact information for the St.~     Michael's Hospital and Women's College Hospital addiction medicine services. The Rapid~     Intervention group will be seen by an addiction physician from one of these services, within~     a day or two of their admission to the WOD or the SMH WMS. The addiction physician will~     prescribe buprenorphine or anti-alcohol medications, and the physician, nurse and/or~     therapist will provide ongoing counseling, follow-up and shared care with the family~     physician. Outcomes (measured at 6 and 12 months) include treatment retention, health care~     utilization and cost, medications prescribed, and alcohol and opioid use.~   "
85767|NCT01934738|"~     The purpose of this study is to investigate safety, toleration and time course of plasma~     concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two~     age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)~   "
85768|NCT01934725|"~     BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes~     occur at younger ages. Stroke at young age causes marked disability at worst and thus~     long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature~     death compared with background population. Up to 50% of young patients with ischemic stroke~     remain without definitive etiology for their disease despite extensive modern diagnostic~     work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with~     patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the~     only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms~     how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover,~     there are only scarce data on clinical outcome, long-term risk of new vascular events, and~     prevention of such events in these patients.~      DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the~     Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter~     case-control study of young adults (age 18-49) presenting with an imaging-positive~     first-ever ischemic stroke of undetermined etiology (aim N=2000). Patients are included~     after standardized diagnostic procedures (brain MRI, imaging of intracranial and~     extracranial vessels, cardiac imaging, and screening for coagulopathies) and age- and~     sex-matched to healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be~     needed to recruit the planned participant population during a 3-year period. Neurovascular~     imaging and echocardiography studies, and ECGs will be read centrally.~      AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and~     clinical risk factors; (2) Long-term prognosis (new vascular events, functional and~     psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of~     e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and~     hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic~     study, including genome-wide association and candidate gene studies as well as~     next-generation sequencing approach. All analyses consider cardiac functional and~     interatrial structural properties as a possible mediator. Furthermore, SECRETO Family Study~     (substudy) aims at collecting extensive family history of thrombotic events from informative~     patients being screened for SECRETO main study and collect genetic samples from all~     consenting family members for whole-genome sequencing.~      SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk~     factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young~     adults. This study also reveals long-term prognosis of this understudied patient population~     and may discover new genetic background underlying the disease mechanism and provide~     potential targets for drug development.~   "
85769|NCT01934712|"~     This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial~     drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently~     marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.~   "
85770|NCT01934699|"~     The investigators will compare myocard vitality diagnostics using 2D-Strain echography and~     MRI.~   "
85771|NCT01934686|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Indonesia.~   "
85772|NCT01934673|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in subjects with type 2~     diabetes in Malaysia.~   "
85773|NCT01934660|"~     Background:~      - Cardiometabolic diseases are a combination of medical disorders that, when they occur~     together, increase the risk of heart disease and diabetes. Researchers want to learn if~     there is a relationship between these diseases and inflammation (redness, swelling, and~     pain). Inflammation affects the entire body. Researchers will study this relationship in~     people with heart disease and diabetes, and compare it to healthy people.~      Objectives:~      - To learn if there are links between inflammation and cardiometabolic diseases.~      Eligibility:~        -  Adults 18 years of age or older with heart disease or diabetes.~        -  Healthy volunteers 18 years of age or older.~      Design:~        -  Participants will have up to six study visits. There will be first visit, then an~          optional visit 12 months after the first visit.~        -  At the study visits they will have:~             -  Blood taken with a needle in their arm.~             -  An electrocardiogram. Small patches are stuck to the chest and limbs. A machine~               measures electrical signals of the heart.~             -  Completed a number of questionnaires.~             -  A body scan called an FDG PET/CT. A substance will be injected through a tube in~               their arm. They will lie on a special bed that will move in and out of the PET/CT~               scanner. The PET/CT scanner will take pictures of the body. The scan will last up~               to 30 minutes.~             -  Some participants will have other body scans ( FDG PET/MRI). The procedures are~               similar to the FDG PET/CT scan. These other scans will last about 30 minutes~               total.~             -  Some participants will also have a CT scan of their heart. A substance will be~               injected through a tube in their arm. They will lie on a table in a large,~               donut-shaped machine. An X-ray tube will move around their body, taking many~               pictures. This procedure can last up to 2 hours.~             -  Some participants will have tests that measures blood pressure and how the blood~               moves through the body.~             -  Some participants will have small samples of skin and fat tissue taken.~   "
85774|NCT01934647|"~     This clinical trial will study the safety, tolerability, and pharmacodynamics of single~     doses of MK-8892 in participants with PAH. The primary objective is to estimate the measured~     peak effect of the highest acutely tolerated (HAT) single oral dose of MK-8892 on pulmonary~     vascular resistance (PVR).~   "
85775|NCT01934634|"~     The goal of this study is to identify the maximum tolerated dose and dose-limiting side~     effects of LCL161 in combination with gemcitabine and nab-paclitaxel and to provide safety~     data in patients with measurable metastatic pancreatic cancer.~   "
85776|NCT01934621|"~     Individuals with cognitive impairments after stroke sustain significant disability in their~     daily tasks, and account for a significant proportion of stroke-related healthcare costs.~     The proposed study examines a novel intervention, strategy training, that shows promise for~     helping individuals with stroke-related cognitive impairments reduce disability in daily~     tasks, which may lead to reductions in healthcare costs. We predict that strategy training~     will result in significantly greater independence 6 months after stroke compared to an~     attention control intervention, and that strategy training may reduce cognitive impairments.~   "
85777|NCT01934608|"~     To determine the effect of synchronizing a patient's prescription refill schedule on~     medication adherence. The targeted population is Humana members who are currently taking 2~     or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current~     customers of RightSource. Participants will be randomized to one of two groups. Group one~     will be usual care and group two will be the Rx synchronization group.~   "
85778|NCT01934595|"~     It is well accepted that during critical illness there is an increase in protein breakdown~     and loss of lean body mass. Previous studies have shown that during critical illness muscle~     breakdown increases dramatically. The aim of our study is to test the hypothesis that~     critically ill patients have improved outcomes with higher protein supplementation.~   "
85779|NCT01934582|"~     A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients~     transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily~     dosing regimen.~   "
85780|NCT01934569|"~     This study will test the potential for PF-05089771 to interact with a cocktail of drugs~   "
85782|NCT01934543|"~     The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal~     origin observed in patients with insulin-resistance is now thought to be attributable to~     both elevated intestinal production and reduced clearance of these lipoproteins. Substantial~     evidence exists indicating that elevated plasma levels of these lipoproteins are associated~     with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma~     TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with~     insulin-resistance. In this regard, there is some evidence that the clinical recommendation~     to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs)~     reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on~     CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels,~     recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on~     CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on~     postprandial lipid response may be of even greater significance in dyslipidemic patients~     with insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs)~     represent a large proportion of the atherogenic lipoproteins. The general objective of the~     proposed research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal~     lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The~     investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins~     will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs.~     The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated~     with significant alterations in expression of key genes and proteins involved in intestinal~     lipoprotein metabolism.~   "
85783|NCT01934530|"~     This randomized controlled clinical pilot trial compared the efficacy of two soft tissue~     grafting methods for correcting esthetic discrepancies associated with non-molar implants in~     the maxilla. Specifically, it was explored whether defects treated with connective tissue~     grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix~     allografts (ADM).~   "
85784|NCT01934517|"~     The purpose of this study is to evaluate the validity, reliability and reproducibility of~     digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster~     models.~   "
85785|NCT01934504|"~     The goal of the study is to find biological markers (certain proteins or cellular markers~     found in a blood test) that will inform doctors which patients diagnosed with~     ANCA-associated vasculitis (AAV) are most likely to be able to stop their medications~     suppressing their immune systems and remain in remission.~   "
85786|NCT01934491|"~     This study is evaluating the effects of two brain training exercises on: memory, cognitive~     processing and depression symptoms.~   "
85787|NCT01934478|"~     Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would~     be changed from negative to positive by cancer irradiation with liner-accelerator at dose~     6GY or up. The propose of this study is to reveal the irradiation result on Her2 expression~     in human breast cancer.~   "
85788|NCT01934465|"~     Investigators propose to assess, retrospectively and prospectively the safety and~     tolerability profile (number of participants with adverse events) of standard chemotherapy~     and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with~     advanced or metastatic Non Small Cell Lung Cancer.~      All treatment schedules that are going to be assessed are considered by the international~     guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung~     Cancer.~   "
85789|NCT01934452|"~     This prospective study will investigate the characteristics of mRCC patients at time of CR~     in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some~     answers/ refection leads to the following questions :~      Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with~     sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report~     these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify~     potential predictive serum biomarkers of recurrence? (With the aim of isolating blood~     biomarker that can help on treatment discontinuation decision?)~   "
85790|NCT01934439|"~     Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected~     by a chronic stroke.~   "
85791|NCT01934426|"~     Objective: The study aim to establish high risk admission model and readmission model for~     elderly in Taiwan.~      Method: Investigators compare the clinical, epidemiological, and socioeconomic~     characteristics of admitted patients during 1 August,2011 to 31 July,2012. All patients will~     follow up to end of study to identify 14 days readmission and 30 days readmission to~     geriatic ward.~      Expected Outcomes: (1) To compare the prediction value of derivation cohort and validation~     cohort. (2) To identify high risk indicators of admission and readmission for elderly. (3)~     To determine the risk factors in admission elderly association with quality indicators.~   "
85792|NCT01934413|"~     The purpose of this pilot study is to develop and test a technology-enhanced transitional~     palliative care (TPC) intervention for patients and caregivers living in rural locations.~     The investigators hypothesize that access to palliative care will be improved, thereby~     improving patient and caregiver reported outcomes and decreasing the use of costly health~     services.~   "
85793|NCT01934400|"~     Objective: The study is to increasing osteoporosis awareness with fracture risk assessments~     and management as well as fall prevention among elderly in northern region of Taiwan.~      Method: Six community osteoporosis and fall prevention educational programme will be held at~     northern region of Taiwan. A questionnaires design including demographic variables , FRAX~     variables, nutritional variables and osteoporosis and fall knowledge variables as well.The~     pretest-posttest method was used to analyse the effect on education.~      Expected outcomes : (1)Fall prevention educational programme will hold in northern region of~     Taiwan at different communities in order to increasing osteoporosis awareness with fracture~     risk assessment tool, establishing fall knowledges among elderly and some fall prevention~     skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than~     20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk~     of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend~     for BMD measurement.~   "
85802|NCT01934283|"~     Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to~     post operative adhesions and most of them resolve without the need of surgical intervention.~     The most important thing dealing with SBO is to identify the more complex obstructions that~     need surgery.~      Some clinical, physiological and radiological signs are recognized as markers of a more~     complex obstruction.~      The pathophysiology of bowel obstruction is explained as damage created by pressure on the~     abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure~     intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.~      In this study we will measure the intra-abdominal pressure in SBO patients systematically~     and we will examine if more severe obstructions are accompanied by elevated intra-abdominal~     pressure.~   "
85794|NCT01934387|"~     BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®)~     Taiwanese calculator is freely available on line to help osteoporosis management. However,~     its clinical utility for improving osteoporosis awareness and patient acceptance has not~     been validated in Taiwanese population.~      OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults~     participating in the geriatric health examinations (GHEs) at the National Taiwan University~     Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and~     to improve patient awareness in osteoporosis. The second aim is to look for the~     recommendations from the participating physicians to improve the FRAX® -based osteoporosis~     management model.~      METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting~     annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE~     visits after informed consent. Baseline questionnaires including the FRAX® tools will be~     distributed and expected to be returned at the stage 2 visits. Research assistants will~     calculate the 10-year predicted fracture risks for the participants during the waiting~     periods and present the numbers to the GHE physicians. High risks individuals will be~     referred to general geriatric clinic for further managements. All participants will be~     provided with osteoporosis and fracture educational material. Patient acceptance and~     awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll~     roughly 1,800 older adults assuming refusal rate about 40%.~      Qualitative interviews will be used to obtain recommendations from study geriatricians in~     Jul., 2013 to optimize the FRAX® based screening and management model.~   "
85795|NCT01934374|"~     Task-oriented exercises combined with strengthening have been shown effective in improving~     walking functions in patients with chronic stroke. However, similar approaches of~     therapeutic exercises have not been applied to subacute stroke with long-term follow-up,~     using outcome measures across the three levels of functioning (body functions/structure,~     activities, and participation) of the International Classification of Functioning,~     Disability, and~      Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:~        1. To investigate the long-term effects of a four-week task-oriented lower extremity~          strengthening training (TOLEST) program in patients with subacute stroke;~        2. To investigate the interrelationships among functional connectivity of the brain, lower~          extremity motor functions, physical activity level, and quality of life in patients~          with stroke who have received this four-week TOLEST program in the subacute phase of~          stroke; and~        3. To identify prognostic factors for recovery in functional connectivity of the brain,~          lower extremity motor functions, physical activity level, and quality of life in~          patients with stroke who have received this four-week TOLEST program in the subacute~          phase of stroke.~   "
85796|NCT01934361|"~     This is a multi-center, phase Ib/ II study (two parts) with patients that have recurrent~     glioblastoma multiforme. The first part (phase Ib) will investigate the maximum tolerated~     dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with~     every-three-week carboplatin or buparlisib once daily in combination with every-six-week~     lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2~     arms, the corresponding phase II portion of the study will start. Phase II will assess the~     treatment effect of buparlisib in combination with carboplatin in terms of Progression Free~     Survival (PFS) and will compare the treatment effect of buparlisib with lomustine versus~     lomustine plus placebo in terms of PFS.~   "
85797|NCT01934348|"~     This study aims to implement and refine research protocols required for a full-scale~     randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA~     is a promising acute intervention designed to reduce the severity and duration of~     trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA~     with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services~     on key psychiatric outcomes from baseline through 4 months post-baseline.~   "
85798|NCT01934335|"~     The purpose of this research study is to test whether vandetanib has an effect on tumor~     growth markers. Vandetanib is not approved by the FDA for use in treating breast cancer.~     This study will compare vandetanib to a placebo.~      The proposed study is designed to determine the change in Ki-67 expression on paired breast~     cancer samples obtained before and after treatment with vandetanib. Other tumor markers~     including RET, TUNEL and phosphorylation specific levels of ERK1/2, AKT and mTOR will also~     be assessed on the paired samples.~      Subjects who have a core biopsy of the breast which demonstrates invasive breast cancer and~     requires surgical excision of the lesion will be eligible for inclusion in the study. The~     tyrosine kinase inhibitor, vandetanib 300 mg, will be given once a day for 14 days prior to~     surgery. Following surgery, tissue markers would be analyzed on each of the paired samples,~     allowing for rapid assessment of in vivo response to TKI treatment.~   "
85799|NCT01934322|"~     The purpose of this study is to evaluate a specific case management intervention for~     frequent users (FU) of Emergency Department (ED).~      Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable~     patients because they are more likely to be of low social and economical status, be more~     isolated and live alone. They report more chronic medical conditions, have a higher~     mortality rate and consume more healthcare resources.~      In the literature, interventions aimed at improving the management of ED-FU have~     demonstrated several positive outcomes, but there are still some knowledge gaps.~      The proposed project tests the hypotheses that case management intervention as compared with~     standard emergency care~        -  is a more efficient use of healthcare resources and reduces ED attendance,~        -  is cost-saving and~        -  improves quality of life,~        -  altogether leading to favorable cost-utility ratio.~   "
85800|NCT01934309|"~     The purpose of this study is to evaluate the impact of implementing a clinical decision~     support reminder system for medical providers (i.e., nurses, clinical officers, medical~     officers, consultants) to improve tuberculosis case-ﬁnding and the use of isoniazid~     preventative therapy for adults living with HIV in western Kenya.~   "
85801|NCT01934296|"~     The purpose of this study is to use an investigational device to record brain activity for~     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The~     goal of the study is better understanding of brain activity in movement disorders and how~     they relate to DBS, not to bring new devices to market.~   "
85803|NCT01934270|"~     Proper growth in children is a complex process regulated by a combination of genetic,~     nutritional, environmental, hormonal, and others. Growth hormone (GH) is the main hormone~     regulating the growth from childhood to adulthood. Despite great progress in the field, with~     the development of recombinant GH for the treatment of growth hormone deficiency (GHD),~     there is still no reliable method for testing GHD. Physical exertion is one of the~     significant physiologic stimuli for GH secretion, and it is reliable test for identification~     of GHD. It is not in use in the clinics because of its complexity. Recently GH secretion~     following short anaerobic exercise in young adults was tested and also demonstrated~     significant growth hormone secretion~      In contrast to adult children's exercise is characterized by an anaerobic nature. There is~     no data about secretion of growth hormone in response to anaerobic exercise in children.~      Purpose of the experiment:~      The purpose of this study is to evaluate the secretion of growth hormone in response to~     anaerobic exercise in children.~   "
85804|NCT01934257|"~     This clinical trial will determine if the formula given to infants experiencing fussiness,~     crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve~     symptoms.~   "
85805|NCT01934244|"~     This post approval, observational study is being conducted to further evaluate the safety of~     the NovaSure Endometrial Ablation System when it is performed in the presence of Essure~     micro-inserts.~   "
85806|NCT01934231|"~     Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in~     clinical practice, which has with respiratory symptoms including nasal congestion,~     rhinorrhoea, postnasal discharge and cough and is associated with headache, cheek pain,~     facial pressure and other conditions. The principal bacterial pathogens in causing ABRS~     include Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella)~     catarrhalis. These three bacteria account for approximately 90% of ABRS in children less~     than or equal to 5 years of age. Combination of Potassium Clavulanate (CVA) and Amoxicillin~     (AMPC) produces higher antibiotic activity against beta-lactamase-producing bacteria. The~     present study is designed to assess the clinical efficacy, bacteriological efficacy and~     safety of CVA/AMPC (1:14) administered in children aged from 3 months to less than 15 years~     with ABRS. It is an open-label study consisting of a 7-day treatment phase and a~     post-treatment follow-up phase for 7 to 14 days.~   "
85807|NCT01934218|"~     The purpose of this study is to determine whether Gel-One demonstrates a superior~     effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS)~     injections.~   "
85808|NCT01934205|"~     Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations~     in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid~     (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and~     alveolar macrophages represent an ideal estimate of concentrations at the site of infection~     and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial~     concentrations via BAL is not routine in clinical practice due to its complex methodology~     and poor patient tolerability. This study will evaluate intrapulmonary and plasma~     pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a~     Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following~     intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate~     the single dose PK profiles. Part B is optional and will only be conducted if necessary.~     Each part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be~     dosed initially; cohorts 5 and 6 are optional and will only be dosed if additional~     time-points are necessary to adequately model the pulmonary pharmacokinetic profile.~   "
85809|NCT01934192|"~     This is a multi-center, parallel group, placebo-controlled and active-compared, randomized~     study to assess the ability of GSK962040 to enhance the delivery of enteral feed to~     critically ill subjects that are predisposed to developing feeding intolerance (e.g.,~     percentage of goal volume); enhance gastric emptying in this population; and provide~     preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the~     Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day~     mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics~     upon repeat dosing in a critically ill population.~      After meeting eligibility criteria, male and female subjects will be randomized to either~     receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric~     (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop~     intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive),~     study treatments will switch such that those originally receiving GSK962040 will receive~     metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally~     randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if~     subjects develop intolerance prior to any treatment, they will be randomized to receive~     either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).~      The study will consist of a screening/baseline assessment, a treatment period (up to 7 days~     in duration), and a 4-day post treatment safety follow-up assessment. The duration of each~     subject's participation in the study from screening to follow-up safety assessment will be~     up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission~     to the ICU.~   "
85810|NCT01934179|"~     This pilot research trial studies telomere length in predicting toxicity in older patients~     with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.~   "
85811|NCT01934166|"~     To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene~   "
85812|NCT01934153|"~     The purpose of this study is to characterize the pharmacokinetics (PK), safety and~     tolerability of topically applied umeclidinium following single dose topical administration.~     The results from this study will be used to 1) improve our understanding of the risk of~     systemic accumulation upon chronic administration, 2) support dosing recommendations in a~     2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study~     for palmar administration, and 3) confirm whether the same formulation can be used for~     axillary and palmar application for the next studies.~   "
85847|NCT01933698|"~     The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the~     bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian~     volunteers.~   "
85813|NCT01934140|"~     The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9~     to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY~     when given to healthy subjects 11 to 55 years of age. In addition, the safety and~     immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects~     10 years after the primary vaccination will be evaluated.~      All Filipino subjects who received the primary vaccination in the primary vaccination study~     107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase.~     No new subjects will be enrolled.~   "
85814|NCT01934127|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age.~     The study will evaluate safety related events and antibody immune responses to different~     formulations of study vaccine and placebo.~   "
85815|NCT01934114|"~     The purpose of this study is to determine whether an experimental alternative imaging~     method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled~     respiratory system to examine the breasts for cancer. The NIR system uses light beams to~     produce an image or picture of the inside of the breast. The respiratory system will help~     researchers get more information about the breast tissue by changing the amount of oxygen~     the tissue receives during NIR imaging.~   "
85816|NCT01934101|"~     Primary Objective:~      • To determine the safety and tolerability of single and multiple ascending oral doses of~     CHR-5154 in healthy volunteers.~      Secondary Objectives:~        -  To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.~        -  To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of~          CHR-5154 in the fed and fasted state.~   "
85817|NCT01934088|"~     Sedation for endoscopy is a service more than a necessity. Therefore it should be patient~     driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic~     control. Therefore, satisfaction with the procedure experience is paramount for patients~     with IBD. Investigators wish to study the feasibility and the effect on patient experience~     of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with~     a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated~     with propofol has a better procedure experience, that a well performed sedation equals a~     better experience and that NAPS is as feasible as fentanyl with midazolam sedation.~   "
85818|NCT01934075|"~     The purpose of this study is to determine whether a mental health intervention for obstetric~     fistula patients in Tanzania improves primary outcomes (depression, PTSD and somatic~     symptoms) and secondary outcomes (coping, perceived stigma, social support, social~     participation, efficacy to engage with providers, adherence to clinical recommendations and~     social reintegration).~   "
85819|NCT01934062|"~     This is a retrospective chart review to assess the incidence and the degree of blood~     pressure changes after induction of anesthesia and to study the effect of different~     induction agents on blood pressure.~   "
85820|NCT01934049|"~     Hip fractures incidence grows rapidly with the aging of the population. After indicated~     surgical treatment, hip fracture patients experience high rates of postoperative~     complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD),~     leading to poor postoperative recovery during hospitalization, which can cause disability,~     distress for both patients and their families, are associated with other medical~     complications and account for significant additional health care costs. We currently use~     dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in~     order to improve postoperative recovery and prevent and treating PD and POCD.~      Dexmedetomidine is a drug used for sedation in critically ill patients that provides some~     pain relief and controls the bodies response to stress. The sedation produced by~     dexmedetomidine appears more similar to natural sleep than any other drug used for~     anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent~     delirium following cardiac surgery and the developing understanding of the causes of PD and~     POCD suggest that dexmedetomidine will be particularly effective.~   "
85821|NCT01934036|"~     The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on~     anthropometric and physiological variables in Spanish women between 35 and 60 years who are~     overweight or obese.~   "
85822|NCT01934023|"~     This laboratory pilot study will explore the effects of varenicline tartrate on long-term~     potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral~     prefrontal cortex (DLPFC) and working memory in non-smoking patients with schizophrenia and~     healthy controls using a Paired Associative Stimulation (PAS) method. The present study will~     use this novel PAS method to evaluate the effects of five doses of varenicline (Champix) 0.5~     mg BID treatment on neuroplasticity changes and working memory in 28 non-smokers with~     schizophrenia and 28 non-smoking controls in a placebo-controlled, double-blinded,~     cross-over design. The hypothesis is that varenicline will increase LTP-like facilitation of~     the DLPFC as compared with placebo in patients with schizophrenia, with less or a null~     effect in healthy controls. Likewise, it is hypothesized that varenicline will specifically~     improve working memory in patients with schizophrenia as compared with placebo and healthy~     controls. We Hypothesize that: 1.Patients with Schizophrenia(SCZ) will have reduced cortical~     LTP and impaired working memory compared to healthy controls 2. Sub-chronic varenicline~     challenge will attenuate the cortical LTP and working memory deficit in patients with SCZ.~     3.Reversal of the cortical LTP deficit by varenicline in patients with SCZ will be~     associated with improvement in working memory.~   "
85823|NCT01934010|"~     The purpose of this research study is to test the safety and local tolerance of repeated~     treatment cycles of AM-101.~   "
85848|NCT01933685|"~     The purpose of this study is to define the immune responses induced by a HIV vaccine,~     AIDSVAX B/E. Blood and mucosal samples will be collected to assess immune responses.~   "
85849|NCT01933672|"~     Study B1621019 will assess efficacy and safety of two different dosing regimens of an~     investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients~     with type 2 diabetes~   "
85951|NCT01932346|"~     Near infra-red spectroscopy (NIRS) was used to measure the tissue perfusion of the cerebral~     cortex with two noninvasive adhesive patches in recent years. This study is designed to~     compare the regional tissue perfusion of different body areas in patients receiving coronary~     artery bypass surgery under general anesthesia. The NIRS data will also be used to compare~     with other routine physiological monitors in the surgery.~   "
85824|NCT01933997|"~     objective: To assess the safety, tolerability and pharmacokinetics of metadoxine,~     administered as repeated oral doses of MG01CI tablets (2 X 700 mg metadoxine per~     administration), to healthy adult subjects.~      This is a single center, open-label, repeated-dose study in healthy male and female~     volunteers. Subjects will undergo screening within 21 days prior to the first dosing to~     assess their eligibility to participate in the study.~      All subjects will receive 1400 mg metadoxine as two MG01CI oral extended-release tablets,~     administered once daily for five consecutive days.~      Blood samples for metadoxine (which consists of two components: pyrrolidone-5-carboxylate~     and pyridoxine that can be identified in plasma concentration assays) will be drawn at~     designated time points, as described in the pharmacokinetic (PK) evaluation section. The~     subjects will remain confined to the unit for 6 days after first dosing.~      A study termination visit will take place 10-12 days after the last dosing day. The subjects~     will be monitored for safety, and AEs (Adverse events) will be recorded throughout the~     study.~   "
85825|NCT01933984|"~     This study evaluates whether individualized dosing schedule of inhaled bronchodilator is~     more effective than fixed dosing in reducing airway resistance of intubated COPD patients.~   "
85826|NCT01933971|"~     Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the~     same active content as Neupogen®. BK0023 is expected to have the same tolerability profile~     and clinical effects as Neupogen® in controlling myelo-toxicity induced by chemotherapy~     given for the treatment of solid and haematological tumours. It is worth noting that the~     production and manufacturing procedures allow to have a reduction of drug cost thus it is~     likely to have pharmacoeconomic advantages.~      The study is aimed at investigating the pharmacodynamic equivalence and the pharmacokinetic~     bioequivalence of the new BK0023 injectable formulation of filgrastim 0.3 mg/mL by Bio-Ker~     S.r.l. vs. the comparator (Neupogen® 0.3 mg/mL, Dompé Biotec S.p.A., Italy). Healthy male~     subjects will receive test and reference at the doses of 2.5 and 5 µg/kg/day for 7~     consecutive days and at the dose of 10 µg/kg/day for 5 consecutive days according to a~     randomised cross-over design. Pharmacodynamics, pharmacokinetics and safety of BK0023~     injectable formulation 0.3 mg/mL and of Neupogen® 0.3 mg/mL, administered in 2 consecutive~     periods with a wash-out of at least 28 days elapsing between the last injection of period I~     and the first of period II, are compared.~      Study design: Single and multiple escalating dose, double-blind, randomised, two-way~     cross-over, pharmacodynamic and pharmacokinetic bioequivalence study.~   "
85827|NCT01933958|"~     The objective of this study is to assess safety and effectiveness of Regorafenib using in~     real clinical practice~   "
85828|NCT01933945|"~     This study will collect data of patients who are treated with TACE followed by sorafenib for~     hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a~     prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was~     documented retrospectively, this study will collect more detailed information about the TACE~     treatment and the status of a patient when treatment with sorafenib is started.~   "
85829|NCT01933932|"~     The purpose of this study is to assess the efficacy of selumetinib in combination with~     docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with~     locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also~     assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the~     selumetinib/docetaxel combination, compared to placebo in combination with docetaxel~   "
85830|NCT01933919|"~     The objective in 1st phase of this randomized study is to evaluate the efficacy of SME3110~     compared to placebo on change in total score of Japanese version of the Children's~     Yale-Brown Obsessive Compulsive Scale 10-item for children from baseline to the last~     observation visit in pediatric/adolescent Obsessive Compulsive Disorder subjects in~     short-term (10 weeks) in double blind period. The safety of SME3110 compared to placebo is~     also evaluated.~      The objective in 2nd phase of the study is to evaluate the long-term safety and efficacy of~     SME3110 in pediatric/adolescent Obsessive Compulsive Disorder subjects.~   "
85831|NCT01933906|"~     In this phase I pilot study, it is planned to investigate the feasibility and safety of~     adding an interferon therapy to an preexisting imatinib treatment in patients with chronic~     phase chronic myeloid leukaemia. The participating patients have already reached a response~     during their imatinib therapy (CCyR) but have still a detectable disease (no molecular~     response MR 4.5 or better).~   "
85832|NCT01933893|"~     Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF~     treatment in general, and in particular in repeated implantation failure (RIF). However,~     there is virtually no data regarding the optimal timing for the pipelle.~      The current study aims to compare between follicular and luteal pipelle on pregnancy rate in~     RIF patients.~   "
85833|NCT01933880|"~     The purpose of this long term post-marketing study is to evaluate the effectiveness and~     safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in~     participants with Attention Deficit Hyperactivity Disorder (ADHD).~   "
85834|NCT01933867|"~     Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms~     of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory~     bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to~     our preliminary experience, water immersion could be beneficial while scoping these~     patients. As far as the investigators know, water-aided colonoscopy has never been studied~     in this indication. Results of our trial might support use of water-aided colonoscopy in~     common practice and decrease associated discomfort in IBD patients.~   "
85835|NCT01933854|"~     The investigators aim to study the prevalence of urinary incontinence in women who live in~     the riverside community in the state of Amapa (The Bailique Island) and compare it to the~     prevalence of urinary incontinence in women who live in the urban region -Macapa-the capital~     city of the Amapa State - Brazil.~   "
85850|NCT01933659|"~     Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and~     minerals and is obtained from the water flows 200 meters under the surface of the sea. The~     inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to~     now, there is few randomized control study to evaluate the anti-bacterial effects of~     ingesting DSW in patients with H. pylori infection.~      The aims of this study are:~        1. to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori~          infection;~        2. to evaluate the patient adherence and adverse effects of ingesting DSW.~   "
85836|NCT01933841|"~     Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative~     tools, but their use carries the potential risk of serious postoperative complications.~     NMBD-induced muscle weakness that lingers into the postoperative period, known as~     postoperative residual curarization (PORC), is present in as many as 40% of all patients~     that receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be~     introducing monitoring as part of standard of care. This study will collect data about~     patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.~      Our study is designed to test the following hypotheses:~      Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU~     entry evaluation will change practitioner behavior in a manner that decreases the incidence~     of PORC in surgical patients at VUMC.~      Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the~     incidence of short- and long-term postoperative complications at VUMC.~   "
85837|NCT01933828|"~     In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A~     resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open~     procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence~     for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation~     yet. The objective of this study is to assess the benefits of VATS- over open lobectomy~     regarding quality of life and costs in a prospective randomized controlled multicenter~     trial. All patients meeting the inclusion criteria that are not randomized will be included~     in a prospective Cohort.~   "
85838|NCT01933815|"~     This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized~     study (phase 2).~      The purpose of the dose-escalation study (phase 1) is to determine the safety, maximum~     tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in~     subjects who have glioblastoma multiforme (GBM) that has progressed following prior~     radiation therapy and temozolomide (TMZ).~      The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the~     phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects~     who have GBM that has progressed following prior radiation therapy and TMZ.~   "
85839|NCT01933802|"~     The study is an open-label, phase I clinical trial designed to evaluate the safety and~     tolerability of intrathecal administration of autologous mesenchymal stem cell-derived~     neural progenitor cells (MSC-NP) in patients with progressive multiple sclerosis. Study~     participants will receive three intrathecal injections of culture-expanded autologous~     MSC-NPs at three month intervals.~   "
85840|NCT01933789|"~     The purpose of this study is to improve care delivered to patients with serious illness by~     enhancing communication among patients, families, and clinicians in the outpatient setting.~     We are testing a new way to help patients share their preferences for talking about~     end-of-life care with their clinicians and families. To do this we created a simple, short~     feedback form. The form is designed to help clinicians understand what patients would like~     to talk about. The goal of this research study is to show that using a feedback form is~     possible and can be helpful for patients and their families.~   "
85841|NCT01933776|"~     The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of~     participants in China.~      Primary objective:~        -  To describe the safety in terms of occurrence of serious adverse reactions and grade 3~          adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given~          as a single dose in 20 adults and 20 children.~      Secondary objective:~        -  To describe the full reactogenicity profile after administration of sanofi pasteur's~          Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.~   "
85842|NCT01933763|"~     Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy~     volunteers.~   "
85843|NCT01933750|"~     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision~     in patients who require reading glasses~   "
85844|NCT01933737|"~     The elderly population has increased significantly in the last years. The number of falls~     has also increased due to the decrease of balance. The Kinesio Taping (KT) is a method with~     the aim to improve muscle physiology, proprioception, coordination and balance. The aim of~     the study was to investigate the effect of KT on postural balance in the elderly. We~     evaluated 62 elderly with a mean age of 67.98±5.321, female, submitted to the protocol for~     the application of KT in gastrocnemius muscles of the midfoot and a placebo tape (3M~     Micropore) in the control group. The application of the tapes was bilateral. Half of the~     participants (n=31) received KT in the lower limbs, while the control group (n=31) was~     applied placebo tape. To analysis of posture and balance, we used a force plate to record~     stabilometric signals. Both groups were evaluated post-application and 48 hours after~     application of the tape. The variables used were total displacement in centimeters (cm),~     amplitude AP (anterior-posterior) and ML (medial-lateral) in centimeters, area (cm²) and~     speed AP and ML in centimeters for seconds. The experimental protocol was performed in~     standing posture and the subjects were instructed to stand with feet apart, eyes open to~     look at the fixed point 1.5 m from force plate in a horizontal direction. It was requested~     that the elderly maintain the position for a time of 40 seconds to collect data The data~     were collected immediately post application of tapes and after 48 hours. The data was~     tabulated, descriptive statistics were calculated. Statistical analysis was performed using~     the GraphPad Prism 4.0 software (Prism, Chicago, IL). The Kolmogorov Smirnov test was used~     to verify the data distribution. Differences between the means were evaluated using the~     Student T test for the normally distributed data, and using the Mann-Whitney test for the~     data not normally distributed. Significance levels were set at p<0.05.~   "
85845|NCT01933724|"~     This is a randomized controlled trial in patients with a diagnosis of granulomatosis with~     polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose~     glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment~     entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares.~      This study is a novel approach to conducting a randomized clinical trial in the community~     setting. This study is being conducted in parallel with a similar study at established~     vasculitis institutions. This study will have a patient centric approach to research in that~     subjects will be recruited online and through social media and vasculitis support networks.~     Participants will be consented online and will receive care through their regular treating~     physician so no travel or additional doctor visits are required. Study participants will~     consent to the study and complete online questionnaires about their prednisone dose and~     about how they are feeling.~   "
85846|NCT01933711|"~     Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by~     prolonged exposure to the drug. To test for this hypothesis we performed a prospective~     randomized trial of rituximab maintenance therapy versus observation in patients (pts) with~     aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.~   "
85853|NCT01933620|"~     Background:~      - The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every~     person s body contains microorganisms like these. They normally do not make people sick.~     Researchers are interested in how these microorganisms change when a person is hospitalized.~     They want to find out if changes take place because of the hospitalization (such as~     treatments used or changes in medical condition) or because of a person s biology (such as~     their immune system).~      Objectives:~      - To understand which microorganisms are most likely to spread through hospitals and what~     affects that spread.~      Eligibility:~      - People over 2 years of age who are going to be inpatients at the National Institutes of~     Health Clinical Center (NIHCC) for at least 1 week.~      Design:~      - Clinicians will take samples from participants up to once a day for as long as they are~     hospitalized at NIHCC.~      <TAB>- Blood will be taken from a needle in the arm. This will be done only once, unless the~     participant gets a certain infection.~        -  Swabs will be taken with a cotton swab, from the rectal area, groin, throat, and~          armpit, and possibly other areas.~        -  Participants may give a stool sample or be asked to spit into a cup.~        -  Clinicians will collect some information from participants medical records. They may~          request some samples of tissue that are left over from procedures already scheduled at~          NIHCC.~        -  After participants leave the NIHCC, samples may be taken when they return for follow-up~          visits from their hospitalization, for up to 2 years. They will not have to return as a~          follow-up for this study only.~   "
85854|NCT01933607|"~     The study is being conducted to evaluate look the TOPS System when used in patients with~     degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates~     for spinal fusion.~   "
85855|NCT01933594|"~     Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot~     cure HIV infection because a small amount of virus remains in cells as a hidden (latent)~     form. The purpose of this study is to evaluate the safety and efficacy of single dose and~     multiple dose administration of romidepsin (RMD) in HIV-infected adults.~   "
85856|NCT01933581|"~     Coronary artery disease and heart attacks are the leading cause of death in the UK. Our~     population is ageing. The number of older patients suffering heart attacks and having~     angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty,~     older patients (80 years of age or over) are at 5 times increased risk of death at one year~     compared to their predicted normal life expectancy. In addition, many patients present with~     further heart attacks, stroke and undergo repeat heart catheter test and angioplasty~     procedures. At present it is not clear who will or will not experience further problems in~     the future. The ability to predict who will and will not suffer future problems at the time~     of initial presentation can be helpful in providing additional treatment and close~     monitoring to those that are at risk of further problems. The ICON 1 study is set out to~     study just that. In this study, older patients will undergo a comprehensive evaluation of~     the cardiovascular disease burden by undergoing additional investigations. These results~     from each patient will be used to develop a risk score that will inform physicians of the~     patient's future risk of developing adverse events and provide a better understanding of how~     to manage older patients with coronary artery disease and also help plan future studies~     looking at treatment strategies that might be beneficial in improving outcomes.~   "
85857|NCT01933568|"~     A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to~     treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal~     lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with~     concurrent chemotherapy. It is hypothesized that this will lead to an increase of local~     control and overall survival~   "
85858|NCT01933555|"~     Although domestic violence is recognized as major threat in pregnancy, there is no~     intervention has been developed or test to support women in India. To evaluate the effect of~     women's empowerment program administered to abused women in order to reduce domestic abuse,~     improving health status and safety behavior.~   "
85859|NCT01933542|"~     Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the~     resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose~     is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after~     spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce~     opioidconsumption and side effects compared to placebo.~   "
85860|NCT01933529|"~     The purpose of this study is to determine whether a non-hematopoietic erythropoietin~     analogue, ARA 290, exerts beneficial effects on blood glucose levels and insulin secretion~     in persons with prediabetes (impaired glucose tolerance, IGT, or impaired fasting glucose,~     IFG), or drug-naive type 2 diabetes.~      The study will also evaluate effects of ARA 290 on insulin sensitivity and serum levels of~     inflammatory agents, e.g. cytokines. In addition, safety will be monitored by following~     parameters related to hematology, kidney and liver function and lipid levels.~   "
85861|NCT01933516|"~     The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese~     patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing~     schedule.~   "
85862|NCT01933503|"~     This is a single center, open label, randomized, parallel design, single and multiple dose~     trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid~     (OCA).~   "
85863|NCT01933490|"~     Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring~     in some patients after gastric bypass surgery for obesity. The pathogenesis is incompletely~     understood but involves a robust insulin response to ingested carbohydrate. The resultant~     hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia, confusion and even~     loss of consciousness. Various treatments have been recommended including low carbohydrate~     diets, coingestion of the medication acarbose with carbohydrate containing meals, partial~     pancreatectomy and even total pancreatectomy. None is completely satisfactory. We propose to~     test two new potential treatments. Using a design with random assignment of three conditions~     we plan to compare, in 10 patients with post-gastric bypass hyperinsulinemic hypoglycemia, a~     high carbohydrate test meal (control condition), a high carbohydrate test meal after~     pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low~     glucose test meal with carbohydrate and caloric content similar to the control meal~     (fructose condition).~   "
85864|NCT01933477|"~     The purpose of this study is to understand how to improve health care services for~     HIV-positive women during their pregnancy and after delivery. The study's aim is to compare~     two different ways of providing antiretroviral therapy for pregnant women with HIV. The~     study is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There~     are three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive~     HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2~     is an observational cohort that will follow women from Phase 1 who are eligible for ART~     (n=600) from the second antenatal clinic visit until the first postpartum visit; Phase 3 is~     a randomized trial of women from Phase 2 who are breastfeeding and will compare two~     different service models for delivering ART to women after they delivery their babies~     (n=480). For Phase 3, women who are taking ART will randomly be assigned to either (1)~     referral to receive ART at the nearest adult clinic at 4-8 weeks after delivery (this is~     currently how all women receive care in this setting) or (2) to continue to come to the~     antenatal clinic for ART services until the end of breastfeeding. All women will received~     the standard local ART services (with identical medications and medical treatment); they are~     different because some women will stay longer in care at the antenatal clinic. All women~     participating in Phase 3 will be followed through at least 2 months after they deliver.~   "
85865|NCT01933464|"~     This study is designed to investigate whether topical application of a cromolyn sodium~     solution is able to decrease the facial redness seen in patients with papulopustular~     rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be~     able to have this effect. The study will enroll a total of 10 patients. 5 will randomly be~     assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned~     to receive the placebo solution. All participants will be instructed to apply their assigned~     solution twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks~     after the distribution of the solutions to measure the efficacy of their assigned solution.~   "
85866|NCT01933451|"~     The purpose of this study is to determine whether intraoperative restrictive fluid~     management guided by pulse pressure variation produces a better effect on the postoperative~     lung function, kidney function, inflammatory response and short-term outcome after~     esophagectomy and reconstruction.~   "
85867|NCT01933438|"~     This study evaluates the ability of a supination and external rotation protocol to improve~     the arm function and anatomy of children with birth related brachial plexus injuries.~   "
85868|NCT01933425|"~     To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no~     neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with~     pneumoperitoneum 12 mmHg.~      Hypothesis:~      Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to~     skin surface, cm) compared to no neuromuscular blockade.~   "
85869|NCT01933412|"~     This is an open label clinical study designed to evaluate the safety and immunogenicity of~     Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis~     patients. The study hypothesis is that vaccination with Sci B Vac will achieve a higher~     seroprotection rate and a higher anti-Hepatitis B surface antibody serum titer level than~     vaccination with Engerix-B Dialysis patients will be categorized as naïve or previously~     vaccinated and each group will be randomized to treatment. Naïve patients randomized to~     Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1,~     and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2,~     and 6 months. Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine~     will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B~     Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines~     will be administered via intra-muscular injection to the deltoid muscle. The study will~     consist of three periods: a screening period of up to four weeks, a 24-week open-label~     treatment period, and a 24-week safety follow-up period. The total expected duration of the~     study per subject is 52 weeks as follows: Screening period: approximately 4 weeks; treatment~     period: 24 weeks; and follow up period: 24 weeks. The primary endpoint is the by-vaccine~     difference in the proportion of subjects attaining seroprotective immune response~     (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with~     either Sci-B-Vac or Engerix-B. Secondary endpoints include anti-Hepatitis B surface antibody~     geometric mean concentrations calculated for all subjects upon last active dose; the~     proportion of subjects with anti-Hepatitis B surface antibody concentrations equal to or~     above 10 IU/mL for all subjects at 12 weeks following the first vaccine dose; the~     by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12,~     24 and 52 weeks following the first vaccination. A by-vaccine comparison of adverse events~     will also be performed.~   "
85870|NCT01933399|"~     This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a~     back support) improves the short-term outcome of lower back pain. participants will receive~     standard care (physical therapy, physician treatment), with one group also receiving an~     extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has~     been shown to increase stiffness of the trunk in individuals while wearing it. The~     hypothesis is that the group wearing the inextensible LSO will have improved outcomes over~     the other two groups (standard care or standard care plus the extensible LSO).~   "
85871|NCT01933386|"~     The primary objective of this study is to compare the SoundBite™ Hearing System to~     surgically implanted BCD systems.~   "
85872|NCT01933373|"~     Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with~     an increased pressure of the esophageal sphincter. This leads to impairment to swallow and~     heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal~     muscle layer extending over to the gastroesophageal junction is the treatment of choice for~     achalasia. In order to prevent reflux of stomach content into the esophagus this has to be~     combined with an antireflux procedure where the upper part of the stomach (fundus) is~     wrapped around the esophagus (fundoplication). This procedure can be performed with the~     wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The~     latter introduces an angulation of the esophagus, which possibly may lead to an impairment~     of swallowing ability and passage of food to the stomach. On the other hand, the Toupet~     procedure may give a better control of reflux. The primary endpoint of the study is symptoms~     of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH~     measurements in the esophagus), radiological imaging of swallowing and quality of life.~   "
85873|NCT01933360|"~     Despite of the widespread use, and extensive studies, the optimal route of administration of~     misoprostol before surgical abortion remains to be defined. Following administration of 400~     mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours,~     but the longer the interval the greater the risk or bleeding and expulsion of the uterine~     contents before the surgical evacuation. Sublingual administration seems to give adequate~     plasma concentration and cervical priming faster than oral or vaginal administration. This~     may allow a shorter waiting time with maintained efficacy, less side effects and logistic~     advantages.~   "
85952|NCT01932333|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what~     the body does to the study medication) and pharmacodynamics (the study of the action or~     effects the study medication has on the body) of single- and multiple, escalating oral doses~     of JNJ-40411813.~   "
85877|NCT01933308|"~     Chronic obstructive pulmonary disease (COPD) has a profound impact on the lives of~     individuals who suffer from it. Participants with COPD are often caught in a downward spiral~     that goes from chronic airflow limitation to invalidity and poor quality of life. Exercise~     training is considered the key to successful pulmonary rehabilitation (PR) because it is~     responsible for much of the benefits associated with this intervention. However, despite~     current guidelines recommend high-intensity exercise training. the optimal exercise training~     protocol for PR participants has yet to be determined. Aims: The main goal of the proposed~     research project will be to determine the optimal exercise training protocol in PR. More~     specifically, the objectives will be to compare the effects of continuous high-intensity~     training (CT80), continuous training at the ventilatory threshold (CTVT), and interval~     training (IT) on various PR program outcomes and to compare participant compliance to the~     three training regimens. Methods: One hundred and twenty subjects will be recruited.~     Participants who meet the eligibility criteria and accept to participate in the study will~     be randomized to one of three groups: the CT80 group, the CTVT group, or the IT group.~     Session duration will be adjusted such that the total amount of work performed per session~     will be comparable between the three groups. Assessments will be made at baseline (week 0),~     at program completion (week 12), and one year after program start (year 1). The primary~     outcome measure will be short-term (12 weeks) change in exercise tolerance, as measured by~     the endurance time to constant-load cycling. Secondary outcome measures will include:~     long-term (1 year) change in exercise tolerance; short-term and long-term changes in~     functional status, psychological status, cognition, and health-related quality of life;~     average participant compliance to the target intensity throughout the 12-week program; and~     long-term adherence to exercise recommendations. Relevance: The proposed research will~     inform clinicians and scientists regarding which of the exercise training protocols~     currently used in PR is optimal for COPD participants by examining their short-term and~     long-term impact on physiological, functional, psychological, neuropsychological,~     behavioural and quality of life outcomes. For COPD participants, our findings have the~     potential to improve the effectiveness of a key intervention for the management of their~     disease.~   "
85878|NCT01933295|"~     Insomnia is recognized as the most prevalent and costly sleep disorders and is associated~     with considerable morbidity including significantly reduced quality of life, impaired work~     performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom~     of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields~     equivalent short-term efficacy and superior long-term durability to pharmacological~     treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid~     with menopause will be tested.~   "
85879|NCT01933282|"~     Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma~   "
85880|NCT01933269|"~     The purpose of this study is to assess a relatively new PET (Positron emission tomography)~     radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine~     Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck~     cancer. These limitations include problems with specificity, high background uptake from~     normal structures, difficulty delineating intracranial invasion, and the need to wait~     several weeks after chemotherapy and radiation before imaging. As an amino acid radiotracer,~     rather than a glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not~     yet have FDA (Food and Drug Administration) approval, but does show promise in initial work~     in patients with prostate cancer and brain tumors. Dosimetry work on FACBC has been~     performed at Emory.~      Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven~     squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical~     resection (ie, surgery without preceding chemotherapy or radiation). Patients must have~     pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who~     consent to participate will receive one FACBC PET/CT of the neck, which will require a low~     dose transmission CT of the neck, an intravenous injection of the radiotracer, and imaging~     of the neck that will last up to 1 hour. Patients will have to lie still during the imaging~     time. Total participation time including set up should be less than 90 minutes. Imaging~     results will be analyzed and compared with conventional imaging as well as the surgical~     pathology results~   "
85881|NCT01933256|"~     HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.~      The purpose of this study is to investigate the safety and tolerability of repeat doses of~     HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet~     β-cell number and function will increase over time in response to repeat HIP2B injections.~   "
85882|NCT01933243|"~     Adolescents with anorexia nervosa frequently have associated anxiety, and standard~     medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week~     trial examining the safety, tolerability, and effectiveness of fish oil nutritional~     supplements for anxiety in adolescents with anorexia nervosa.~   "
85883|NCT01933230|"~     The purpose of this study is to determine if cooling the neck of patients with ICH decreases~     brain temperature. In addition, the investigators will determine if the device improves the~     delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers~     intracranial pressure (which is often times high in patients after ICH).~   "
85884|NCT01933217|"~     Traumatic Brain Injury (TBI) - methylphenidate treatment~   "
85885|NCT01933204|"~     The purpose of this study is to determine whether acupuncture is effective for relieving~     perimenopausal symptoms.~   "
85886|NCT01933191|"~     A single bout of physical activity (treadmill)immediately prior to the dental examination~     reduces anxiety in patients with dental phobia.~   "
85887|NCT01933178|"~     Conjunctivochalasis refers to loose redundant, non-edematous inferior conjunctiva that is~     situated between the globe and lower eyelid, and usually it occurs bilaterally. It has been~     reported to cause ocular discomfort, tear instability, alteration of tear spreading and~     subsequently dry eye, which is a common condition that affects vision and quality of life in~     patients. This condition has also been reported to be associated with aging and ocular~     surface inflammation.~      The assessment of conjunctivochalasis was traditionally based on silt lamp examination and~     this may be cumbersome and highly subjective. Only recently, researchers have advocated the~     use of imaging and more objective documentation by anterior segment optical coherence~     tomography (AS-OCT), using Fourier-Domain RTVue-100 OCT. The AS-OCT is an imaging method~     that documents the tear meniscus and prolapse of conjunctiva into the tear meniscus in a~     safe, rapid and non-invasive way. Image analysis on the area of prolapsed conjunctiva can~     then be used to ascertain the severity of conjunctivochalasis. We propose the use of~     HD-Cirrus AS-OCT for the imaging of conjunctivochalasis, since this technique provides more~     magnified and colored digital images, which helps to delineate different tissues and serves~     as a better education tool for patients.~      This current study aims to investigative the inter and intra examiner reproducibility of~     imaging conjunctivochalasis using HD-Cirrus AS-OCT, using patients from the dry eye clinic~     from the Singapore National Eye Centre. These patients will be asked to come to the centre~     for imaging and have three scans of the same eye performed in one session by two trained~     investigators consecutively. The resulting limits of repeatability will be very useful for~     us to follow up patients who undergo surgical or diathermy treatment for~     conjunctivochalasis, and for sample size calculation in the planning of interventional~     studies.~   "
86006|NCT01931631|"~     The purpose of the study is to assess whether, in individuals with type 2 diabetes, a~     low-fat, vegan diet improves blood glucose control more effectively than a control diet~     based on current American Diabetes Association (ADA) guidelines. The principal measure is~     hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The~     study duration is 20 weeks with a one-year follow-up.~   "
85888|NCT01933165|"~     Dry eye clinical research is limited to follow up of disease progression. While a large~     catalogue of tests, such as corneal staining grading, tear break up time (TBUT) and~     Schirmer's test, is available, objective assessments demonstrate poor to moderate~     repeatability. Among these assessments, TBUT has the best repeatability while the Schirmer's~     test shows good repeatability for more severe forms of the disease.1 As such, currently,~     most research outcomes are based on subjective patient complaints rather than objective~     assessment of the condition.~      LipiView Ocular Surface Interferometer (LipiView) is a HSA-approved imaging device that has~     the ability to assess optical interference pattern produced by light reflected off the tear~     film in a safe and non-invasive manner.2 Software analysis of the image then measures the~     tear LLT, which is used to objectively quantify the diagnosis of lipid-deficient dry eye.~      This current study aims to investigative the inter and intra-examiner reproducibility of~     measuring tear lipid layer thickness (LLT) with LipiView, which is used in our current~     clinical setting. LipiView has not been evaluated on its reproducibility of measuring tear~     lipid layer thickness. The study will also assess for correlation between the magnitude of~     tear LLT and the inter and intra-examiner reproducibility of LipiView.~      Once this method is found to be repeatable, this can be used in future clinical settings and~     trials as an additional tool to investigate dry eye treatments.~   "
85889|NCT01933152|"~     Retrospective, non-interventional, observational multi-center field study. Patients~     diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with~     ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened~     and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011.~     Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be~     documented. For each patient, demographics, medical history, administered treatments,~     results of ocular and visual assessments and other tests (where available) will be~     documented.~   "
85890|NCT01933139|"~     To determine whether the addition of audio-visual presentations to standard physician~     interaction improves patient comprehension as it relates to the information provided during~     the informed consent process in patients undergoing hysterectomy.~   "
85891|NCT01933126|"~     The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in~     women undergoing IVF treatment.~   "
85892|NCT01933113|"~     The study is a continuation of the clinical pilot study of lateral hypothalamic area (LHA)~     deep brain stimulation (DBS) for severe obesity. Patients who met the enrollment criteria~     underwent stereotactic placement of bilateral hypothalamic chronic stimulating electrodes.~     The current trial will continue to monitor these subjects as well as objectively measure~     metabolic rate (including energy expenditure, respiratory quotient, oxygen consumption, and~     carbon dioxide production).~   "
85893|NCT01933100|"~     This study was conducted to investigate the effects of rice based-meal on functional~     constipation in young Korean women.~   "
85894|NCT01933087|"~     Infections acquired by patients in hospitals are a major cause of illness and death~     worldwide, and particularly so in hospitals with very limited resources. Simple hygiene~     measures, including improved hand hygiene (particularly with increased use of alcohol-based~     hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be~     amongst the most effective ways of reducing such infections. However, in most hospitals hand~     hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has~     been found to be difficult.~      This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene~     amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health~     Care. The research design is a prospective stepped wedged trial using all in-patient wards~     in a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon~     Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which~     is appropriate when there are prior reasons to believe the intervention will be beneficial~     (as opposed to equipoise) and when it is impractical to deliver the intervention to all~     study units simultaneously. Both conditions hold here. The intervention will include~     educational visits to healthcare workers, improved reminders in the workplace, audit and~     feedback and social marketing with the aim of inducing behavioural and cultural change in~     relation to hand hygiene. The intervention will be delivered by the infection control team~     and the infection control ward nurses (ICWNs) who will receive additional training. The~     primary outcome will be directly observed hand hygiene compliance. Secondary outcomes will~     include incidence density of hospital-associated bloodstream and urinary tract infections~     with specified multiply antibiotic resistant bacteria, incidence density of~     hospital-associated bloodstream and urinary tract infections with non-multiply antibiotic~     resistant bacteria, total patient mortality rates, and ward-based consumption of alcohol~     hand rub and soap (a proxy for hand hygiene compliance).~      Results from this study will be immediately generalisable to other resource-constrained~     hospitals in Thailand. The research will also have much wider international significance as~     there have been very few methodologically sound evaluations of the impact of hand hygiene~     interventions in hospitals. Moreover, the findings will provide essential information for~     subsequent work on economic evaluations of infection control interventions to determine~     under what circumstances such interventions are likely to be cost-effective.~   "
85895|NCT01933074|"~     The purpose of this study is to gain a better understanding of what causes urinary urgency~     in women by asking about different symptoms and measuring biomarker levels in their urine.~     Understanding the underlying causes of urinary urgency will allow us to develop treatment~     options to better take care of women with urinary urgency.~   "
85896|NCT01933061|"~     A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with~     Abraxane administered weekly with respect to overall survival, objective tumor response rate~     and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant~     melanoma.~   "
85897|NCT01933048|"~     The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity~     of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with~     healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group~     self-administration of LAIV.~   "
85898|NCT01933035|"~     To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia~     (ITP) from hypo-proliferative causes of thrombocytopenia.~      To develop the clinical potential of the extended platelet parameters as they pertain to~     distinguishing different causes of thrombocytopenia from one another.~      To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might~     distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated~     destruction of platelets.~   "
85899|NCT01933022|"~     The purpose of this study is to investigate the effect of the study medication (Eligard®) on~     cancer markers (in the blood) of prostate cancer.~   "
85900|NCT01933009|"~     GnRH administration during the luteal phase was found to significantly increase pregnancy~     rates in women undergoing fresh-cycle IVF cycles.~      We aim to investigate the effect of GnRH administration during the luteal phase in women~     undergoing frozen-thawed IVF cycles.~   "
88279|NCT01901783|"~     This study is designed to compare the clinical and histologic results of ridge augmentation~     with and without primary closure over the barrier membrane. The hypothesis is that there~     will be no difference in crestal ridge width between the two groups.~   "
85901|NCT01932996|"~     The goal of this research study is to enhance smoking cessation rates for homeless smokers~     by testing effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse~     treatment with smoking cessation. We will utilize a 3-group randomized design to test study~     hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol~     intervention using cognitive behavioral therapy (CBT), CBT—(IS+A); 2) Intensive Smoking~     Intervention using CBT—(IS); or 3) Usual Care (brief smoking cessation and brief alcohol~     counseling both based on the United States Public Health Service's Guidelines)—(UC). All~     participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.~     Counseling will follow the protocol used in a recent study of alcohol dependent smokers and~     will include weekly individual sessions for 3 months followed by monthly booster group~     sessions for 3 months. As a strategy to integrate proposed project with existing programs at~     the shelters, all group counseling sessions will be co-facilitated by trained study staff~     and trained homeless shelter staff. All 3 study conditions will have equal number of study~     contacts. Study staff will make retention contacts with participants in the community during~     weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified~     7-day smoking abstinence at week 52 follow-up while secondary outcome is prolonged smoking~     abstinence at weeks 12, 24, and 52. Secondary alcohol outcome will be self-reported~     continuous alcohol abstinence for 90 days at week 52. Recruitment and retention will be~     enhanced by use of debit cards, bus passes, other non-monetary incentives, attractive~     intervention materials, collaboration with homeless shelters, and advice from a Community~     Advisory Board. Participants will be enrolled from homeless shelters and facilities in the~     7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a~     sample size of 215 per study condition is needed to detect proposed treatment effects.~   "
85902|NCT01932983|"~     The study examines the clinical application of TOF (train of four test) used by~     anesthesiologists and neurophysiologists during instrumented spine procedures, as well as~     certain associated parameters. 'Train of four' test is a test routinely used during the~     surgery, which is performed by stimulation of peripheral nerve with purpose to determine the~     degree of muscle relaxation by interpretation of muscle response. During spine surgery, it~     is helpful for the surgeon to have a patient's muscles as relaxed as possible with the least~     amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation~     by giving a neuromuscular blocking agent. If medication given to do this has not fully left~     their system by the time the surgeon needs to start putting in the screws and rods, then the~     intraoperative monitoring can not be adequately performed. If the muscles are too relaxed,~     then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed~     correctly and the surgery may be adversely affected. This study compares the results of the~     'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it~     looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or~     hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be~     relevant for many reasons. Train of four tests can show the presence of four twitches in the~     arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also,~     train of four test which uses subjective method of interpretation by anesthesiologists may~     present different results compared than objective quantitative method of train of four test~     interpretation. Ultimately, the goal of this study is to show the importance of 'TOF'~     testing in ensuring that any identifiable preventable intraoperative surgical complication~     is appropriately identified.~   "
85903|NCT01932970|"~     This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on~     serum corrected calcium levels when switching subjects from cinacalcet to AMG 416.~   "
85904|NCT01932957|"~     Standard management for patients with ruptured ectopic pregnancies at our institution is~     treatment by laparotomy. This trail will investigate the feasibility of treatment with~     laparoscopy and will look at outcomes such as hospital stay and pain experienced~      The hypothesis is that laparoscopy is a feasible treatment option associated with shorter~     hospital stay and less pain~   "
85905|NCT01932944|"~     To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System)~     interstitial glucose results against venous glucose reference and capillary fingerstick~     using the Consensus Error Grid over the wear duration. During the course of the wear~     duration, the subject is required to be testing fingerstick glucose measurement at least 8~     times a day for capillary reference glucose measurements and three in-clinic visits of~     maximum 10 hours each for venous reference glucose measurements. With every reference~     measurement, the subject or study staff will perform a measurement on the System.~   "
85906|NCT01932931|"~     In recent years it has become evident that some types of antidepressants are associated both~     with an increased risk of falling and decreased bone mineral density. These factors~     predispose patients for serious fractures such as hip fractures with substantial morbidity~     and mortality. The specific mechanisms involved in this negative impact on bone and postural~     control have not been fully elucidated. It is well known that Vitamin D plays an important~     role for bone health as well as muscle function and thus indirectly postural control.~     Furthermore, vitamin D deficiency has been observed among depressed patients. To our~     knowledge no study has investigated the involvement of Vitamin D in relation to the~     increased risk of fractures associated with antidepressants. Therefore, this project will~     investigate the underlying mechanisms leading to skeletal impairment and musculoskeletal~     symptoms in patients receiving different types of antidepressants. Moreover, the effect of~     vitamin D supplementation will be investigated among patients taking these antidepressants.~      150 subjects will participate in this study: 50 of which is diagnosed with depression and~     receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50~     controls. Through randomisation half of the subjects in each group will receive daily~     Vitamin D supplementation for a period of one year. Through this period all 150 subjects~     will be followed through different measurements including bone density, muscle function and~     balance, nociception, quality of life and depression severity.~      It is expected that results from this study will provide increasing awareness and knowledge~     of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians~     to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly~     provide treatment, which may reduce the incidence of potentially avoidable fractures.~     Moreover, some types of antidepressants may show to produce a minimal or even no effect on~     bone turnover, and should be considered as first line treatment in the group of patients at~     risk of fractures.~   "
85907|NCT01932918|"~     Postoperative pain caused by surgery-associated tissue injury is a major concern for all the~     clinical practitioners. Because it affects multiple systems and induces physiological,~     immunological and psychological changes. Previous literature showed surgical injury induces~     a systemic inflammatory metabolic-endocrine response that is proportional to the severity of~     the surgical stress. In surgeries such as liver transplantation, the patients suffer not~     only from postoperative pain but also an additional oxidative stress caused by ischemia~     reperfusion. Previous report have proved that an adequate postoperative pain control~     improves the recovery and reduces the inflammatory cascade by suppression of physiological~     and psychological stresses. However, the effect of postoperative pain management on ischemia~     reperfusion injury is unclear so far. In this three year study, we plan to continue our~     previous study to test the following two hypothesis: (1) postoperative pain exacerbate~     remote organ injury caused by ischemia reperfusion, (2) the interaction of different~     antinociceptive modalities on ischemia reperfusion injury.~   "
85920|NCT01932749|"~     The aim of this study is to investigate the effect of repetitive TMS in reduction of~     depressive symptoms in patients with bipolar disorder. In a randomized, single blind~     clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be~     assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive~     and anxiety symptoms and quality of life will be assessed before the treatment (pre test)~     during the treatment (10th session), and after the treatment (post test). QEEG apply before~     and after rTMS in all subjects.~   "
86007|NCT01931618|"~     The purpose of this study is to test - in a workplace setting - if an online multi-session~     alcohol intervention improves treatment effect over and above a single session screening~     with feedback.~      Hypothesis: automated online multi-session follow-up improves the effect on alcohol~     consumption over and above a single session screening~   "
85908|NCT01932905|"~     Pain affects up to 30% of the general population. In particular, neuropathic pain (NeP) is~     caused by lesion or desease affecting peripheral or central somatosensory pathways and~     affects 7% of the adult population. Despite the availability of evidence based~     pharmacological and surgical treatment for NeP, about 50% of patients remais symptomatic~     despite best medical treatment. Some neuropathic pain syndromes are specially refractory. In~     particular, central NeP is caused by disease or lesion to central structures involves in~     somatosensory integration of nociceptive information is non-responsive to drugs usually~     employed in other NeP syndromes. Classical neuromodulatory techniques such as conventional~     repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are~     ineffective to relieve pain in this population. Recently new technology advances have made~     possible non-invasive stimulation of deeper cortical targets. Some of them are activelly~     involved in the integration of the perception of pain, such as the anterior cingulate cortex~     or the posterior insula. The aim this study is to treat 90 patients with central pain (post~     stroke pain, spinal cord lesions after trauma or demyelinizating diseases) under best~     medical pharmacological treatment in three different conditions: AAC (n= 30 with the~     H-Coil), Superior Posterior Insula (SPI) n=30 cooled double cone coil double cool coil, and~     sham(n=30). Each patients will undergo daily stimulation for a week, then weekly~     stimulations for 3 months (total of 17 sessions). The main study outcome is pain relief at~     the last stimulation week (visual-analogic scale). Secondary end-points are changes in the~     McGill Pain Questionnaire, Neuropathic Pain Symptom Inventory, DN4 questionnaire, SF -36,~     brief pain inventory and cognitive assessment including the trail making test A and B,~     Strrop color interference test, and subscalles from the CERAD. All patients will undergo~     quantitative sensory test and measurements of cortical excitability over M1 before and after~     to treatment.~   "
85909|NCT01932892|"~     This study will quantify motion occurring at the socket interface of transhumeral prosthesis~     users during common tasks. Participants in the study will use a body powered prosthesis with~     a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded~     into the socket wall will record the amount of movement between the residual limb and socket~     of the prosthesis. Participants will complete range of motion and functional tasks. The~     range of motion tasks include shoulder flexion, abduction and rotation as well as elbow~     flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of~     weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel.~     It is expected that the more weight at the terminal device the more rotation at the~     interface, as well as more slip between residual limb and device. It is also expected that~     the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of~     movement at the interface can be predicted based off the force in the system.~   "
85910|NCT01932879|"~     Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts~     can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid~     class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation,~     and this may be the mechanism by which body fatness is influenced by anthocyanin intake.~     Well-controlled studies in humans are lacking.~   "
85911|NCT01932866|"~     The purpose of this randomized, controlled study is to evaluate whether the knowledge of a~     personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle~     change program in prediabetic patients. The intervention group will receive diabetes risk~     score results at the beginning of the twelve weeks, and the control group will not receive~     these results. Both groups will review their baseline and 12-week diabetes risk score~     results at the conclusion of the program and will be followed for an additional twelve~     weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure,~     HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between~     the groups.~   "
85912|NCT01932853|"~     The aim of this study is to assess whether patients receiving current recommendations of an~     adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months~     compared to those who do not get it, as well as assess whether patients receiving a dose~     greater obtain more benefit.~   "
85913|NCT01932840|"~     Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The~     Canadian government has recently allowed plant sterols to be added to certain foods and has~     also approved a disease risk reduction claim to be allowed on products containing plant~     sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.~      The objective of this study was to evaluate the attitudes and understanding of different~     types of plant sterol claims on food labels~   "
85914|NCT01932827|"~     Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for~     heart health. Oat and fibre claims on food labels should help people find heart healthy food~     choices; however consumer attitudes and understanding of such claims are unknown.~      The objective of this study was to evaluate the attitudes and understanding to different~     types of permitted oat fibre claims.~   "
85915|NCT01932814|"~     The purpose of the present study is to determine whether administration of aminoglycosides~     in septic critically ill patient is a risk factor for acute kidney injury~   "
85916|NCT01932801|"~     The goal of this study is to test the efficacy of extended-release naltrexone and harm~     reduction counseling in reducing alcohol-related harm among homeless people with alcohol~     dependence.~   "
85917|NCT01932788|"~     The purpose of this study is to give all mothers the best chance for a healthy pregnancy~     through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds~     who will receive either the current vitamin D standard of 400 IU/day (in the prenatal~     vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D~     sufficiency).~      This research is sponsored by the W.K. Kellogg Foundation and the Medical University of~     South Carolina. The purpose of this study is to examine the effectiveness and~     infection-fighting properties of the body in relationship to vitamin D levels. This study is~     being done at the Medical University of South Carolina (MUSC) clinics, and will involve~     approximately 450 volunteers.~   "
85918|NCT01932775|"~     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic~     management in non-critically ill patients with type 2 diabetes at general wards.~   "
85919|NCT01932762|"~     This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of~     grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or~     ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype~     (GT) 2, 4, 5, and 6 hepatitis C infection.~      In Part A there is no randomization or stratification; all GT2 participants will be assigned~     to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants~     with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with~     stratification by genotype.~   "
85923|NCT01932710|"~     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts~     them at greater risk of infection. The standard of care for preventing infections is to give~     these patients antibiotic, antifungal, and antiviral drugs during the time that white blood~     cell counts are low. However, many patients still develop infections during chemotherapy.~     Radiated white blood cell transfusions are a standard treatment once a patient develops a~     severe infection.~      The goal of this clinical research study is to learn if giving white blood cell transfusions~     that are not radiated early in chemotherapy might delay or prevent infections in patients~     with leukemia. Researchers also want to learn more about the type and severity of any~     infections that do occur.~   "
85924|NCT01932697|"~     This phase II trial studies how well radiation therapy and docetaxel work in treating~     patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy~     uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving radiation therapy~     with docetaxel my kill more tumor cells.~   "
85925|NCT01932684|"~     Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive~     spirometry (IS) on the volume of the chest immediately after and within thirty minutes after~     the techniques in patients with Parkinson's disease (PD). Methods: This is a study of~     cross-over. The study investigated 14 patients with mild to moderate PD. The subjects~     performed the technique Breath-Stacking, incentive spirometry volume and participated in a~     phase control according to randomization. The volunteers were evaluated by opto-electronic~     plethysmography in four stages: before, immediately after fifteen and thirty minutes after~     the completion of the techniques. The investigators used a repeated measures ANOVA with~     post-hoc Tukey test for parametric variables, and the Friedman test with post-hoc Dunns for~     nonparametric variables. The level of significance was set at 5%, p <0.05.~   "
85926|NCT01932671|"~     After having had a first cardiovascular event, there is a considerable risk of developing a~     subsequent event. Only recently, a risk prediction model was developed for this group of~     patients. Imaging techniques such as the coronary artery calcium score and contrast-enhanced~     computed tomography (CT) of the coronary and carotid arteries could be able to add improve~     this model. Imaging may further improve the prediction of future manifestations of arterial~     disease and personalize disease monitoring and treatment.~   "
85927|NCT01932658|"~     The purpose of this study is to evaluate the safety and potential clinical benefit of~     lymphoablation followed by autologous HSCT rescue in therapy refractory Crohn's disease~   "
85928|NCT01932645|"~     Prostatitis is so widespread a disease that affects people from youths to seniors, with~     approximately a third experiencing a remission of symptoms over a year follow-up. Although~     the etiology of prostatitis is still not clear, it is mainly thought to be due to infection~     of bacteria or other microorganisms. Up to now, there is still no research being done on the~     microbiome (bacterial species) of the prostate. The objective of this study is to look at~     the etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing~     on the effect of bacteria in the prostate.~   "
85929|NCT01932632|"~     The purpose of this experiment is to test the effect of medication minimization on mortality~     and hospitalization in long-term care residents.~   "
85930|NCT01932619|"~     Breast milk is best food for neonates and preterm infants. However many handling would be~     done if direct breastfeeding is not feasible, and it may result in nutrients change in human~     milk. We investigate the influence of storage in different containers and different thawing~     or heating methods on human milk nutrients.~   "
85931|NCT01932606|"~     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that~     has no proven effective treatment. This study assessed the effects of acute nitrite~     administration on resting and exercise hemodynamics in patients with HFpEF.~   "
85932|NCT01932593|"~     There is no cure for Multiple Sclerosis (MS) and we are always looking at new ways to stop~     the disease process and/or promote repair.~      We hypothesise that autologous bone marrow cellular therapy in chronic MS offers durable~     benefit.~      The purpose of this study is to test the safety of repeated bone marrow stem cell infusion~     in patients with MS. We want to find out what effects, good and/or bad, it has on you and~     your disability.~      You have previously participated in a safety study of bone marrow stem cell infusion in~     patients with MS. The results raised the possibility of some early partial repair;~     measurements of the speed of neurological impulses in the brain and spinal cord improved.~     The current study seeks to determine whether those benefits have persisted and whether they~     can be repeated or enhanced by repeating the procedure.~   "
85933|NCT01932580|"~     Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy~     before and after surgery. The chemotherapy regimen used in our institution, called DCF~     (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia~     relief. however, it is toxic, causing approximately half of patients severe inflammation of~     the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting~     and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at~     least equally active, but less toxic.~      Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking~     upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less~     than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to~     proceed with the next trial, a randomized comparison of DCF and FLOT~   "
85934|NCT01932567|"~     To compare the effect of different airway clearance techniques on lung ventilation by~     electrical impedance tomography.~   "
85935|NCT01932554|"~     The purpose of this study is to determine whether giving abciximab (ReoPro) to children with~     sickle cell disease who are hospitalized for acute pain crisis will improve their pain and~     shorten the time spent in the hospital, when compared with standard supportive care.~   "
85936|NCT01932541|"~     This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for~     mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum~     disorders. We hypothesize that Lurasidone will be safe, tolerable, and effective in~     improving the core symptoms of bipolar disorders in children and adolescents ages 6-17.~   "
85937|NCT01932528|"~     To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and~     its primary metabolite LX1033.~   "
85938|NCT01932515|"~     The trial is in three stages and will translate and validate screening and assessment~     instruments for use with deaf children.~      The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for~     use with deaf children. This will involve choosing the most promising screening instrument~     (SRS-2) based on the systematic review and the expertise of a review panel, which contains~     experts and public and patient involvement (PPI). This phase of the study seeks a wide range~     of user (parents/ carers and young people) views and experiences about the symptomatology~     and presentation of deaf children with autism, comparing this to hearing children with~     autism, and deaf children without autism.~      The second stage is to ensure that the newly modified instruments are accessible to deaf~     children and deaf parents by making any necessary translations from English into British~     Sign Language. This involves a strict translation and back translation methodology with~     reiterations until successful translation is achieved.~      For stage three in order to ensure that the new questionnaires are successfully identifying~     children and young people with Autism Spectrum Disorder, the modified instrument will be~     validated using a 'gold standard'. The current 'gold standard' for the mental health~     screening of Deaf children is a clinical interview administered by experienced senior~     multidisciplinary deaf child mental health clinicians.~   "
85939|NCT01932502|"~     The purpose of the study is to examine the clinical safety, tolerability, and efficacy of~     clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with~     refractory epilepsy.~   "
85940|NCT01932489|"~     Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential~     for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by~     examining the feasibility and turnaround time of performing and obtaining data from a few~     key molecular assays.~      Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be~     enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen~     assay will be performed using DNA sequencing.~      Results will be discussed during a molecular screening tumor board.~   "
85941|NCT01932476|"~     The purpose of this study is to determine whether the immune response causing celiac disease~     is related to the autoimmune response causing type-1 diabetes.~   "
85942|NCT01932463|"~     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR~     Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor~   "
85943|NCT01932450|"~     A randomized, open-label single-center study investigates the efficacy and safety of~     bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on~     blood pressure and disease progression control in autosomal dominant polycystic kidney~     disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed~     with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency~     ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic~     blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure~     monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and~     ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure~     tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys~     and renal function, will be assessed at 12 months of follow-up. The safety variables will be~     assessed at every visit of follow-up.~   "
85944|NCT01932437|"~     This study is to evaluate the safety and local tolerability of single intramuscular (IM)~     doses of ETI-204; to evaluate the pharmacokinetics (PK) of a single IM dose of ETI-204; and~     to evaluate the immunogenicity of a single IM dose of ETI-204.~   "
85945|NCT01932424|"~     During major spinal surgery evoked potential monitoring is performed to detect spinal cord~     damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile~     anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with~     propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an~     automated drug delivery system which administers propofol to achieve a desired blood~     concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous~     studies. The TCI model also provides a real time predicted blood concentration to facilitate~     the anaesthetist to adjust the target concentration of propofol.~      The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a~     relatively small number of patients, by a best fit relationship between blood levels,~     infusion rates and other factors (such as age and weight). Several factors make it possible~     for a wide discrepancy between the predicted and the true blood concentrations. This~     difference can be higher in children compared to adults. Also blood loss and administration~     of large volumes of intravenous fluids can affect the blood concentrations. This study aims~     to identify the difference between the predicted and true blood concentrations by using~     Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major~     spinal surgery under TIVA.~   "
85946|NCT01932411|"~     Identify factors that contribute to perioperative morbidity and mortality in patients~     undergoing cardiac surgery that involves cardiopulmonary bypass.~      Identify factors that affect perioperative morbidity and mortality in patients undergoing~     cardiac surgery.~   "
85947|NCT01932398|"~     Investigate the hypothesis that children with ADHD have difficulty with the allocation of~     visio-spatial attention related to an inability to control posterior alpha brain~     oscillations. A paradigm will be used in which the aim is to address covert attention as~     similar recent studies did in adults with ADHD.~   "
85948|NCT01932385|"~     Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in~     China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased~     PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh~     class A patients, but the result for Child-Pugh class B patients is unclear.~   "
85949|NCT01932372|"~     The objective of this Surveillance is to verify the following subject matters concerning~     Tofacitinib (Xeljanz) under general practice.~      1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy~     2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy~      Occurrences of malignant tumors and serious infections will be compared with a control~     group.~   "
85950|NCT01932359|"~     This study aims to compare scar outcomes between rapidly absorbable and non-absorbable~     sutures (stitches) for the closure of wounds after skin cancer removal on the face.~   "
85953|NCT01932320|"~     The purpose of this study is to compare the rate and extent of absorption of a single dose~     of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813~     (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent~     of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and~     to explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and~     extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part~     3).~   "
85954|NCT01932307|"~     There are currently no standardized programs addressing the well-documented neck pain in~     surgeons as a result of non-ergonomic positioning and the use of microsurgical equipment.~     The primary goal of this study is to introduce a brief neck strengthening exercise program~     to optimize surgeons' neck health. Instructional videos outlining the program along with~     surveys designed to assess attitude towards neck health will be distributed to first year~     general surgery residents at the University of British Columbia (UBC) through their required~     online curriculum webpage. A followup survey will be administered 10 weeks later to~     determine efficacy of the program through self-reported adherence and changes in attitude~     towards neck health.~   "
85955|NCT01932294|"~     Medamacs is a prospective, observational study of ambulatory patients with advanced heart~     failure. The study enrolls patients who have not yet received a Left Ventricular Assist~     Device (LVAD) but who receive their care at a hospital with a Joint Commission certified~     mechanical circulatory support program.~      Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support~     (INTERMACS) NHLBI Contract.~   "
85956|NCT01932281|"~     The purpose of this study is to examine whether supplementation with SierraSil can improve~     anaerobic power and reduce muscle fatigue in a group of well-trained athletes.~      A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset~     muscle soreness.~   "
85957|NCT01932268|"~     The purpose of this study is to examine the colchicine concentration before and after the~     administration of rifampicin.~   "
85958|NCT01932255|"~     Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in~     surgery for microvascular decompression is reported up to 3%.~      Prevention of leakage is important since meningitis may follow. Also, leakage usually means~     longer hospital stay and increased cost.~      In case of detected leakage extra sutures may be applied, placement of a lumbar drain may be~     considered or a revision and improved closure may be attempted. With leakage in the~     subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms~     may also occur. In addition to being burdensome and being associated with longer hospital~     stays with possible revision surgery, such complications are also very costly. The best way~     to reduce cost and burden, and to improve patient care, is to prevent CSF leakage.~      The aim of this study is to determine if prophylactic lumbar tap is beneficial for~     prevention of cerebrospinal fluid leakage following microvascular decompression, by~     comparison of surgical approaches in 3 geographical areas in the Scandinavian health system.~      Hypothesis: There is no difference in cerebrospinal fluid leakage between the group subject~     to prophylactic spinal tap versus the group without prophylactic spinal tap.~   "
85959|NCT01932242|"~     To evaluate the safety and tolerability of repeat administration (two doses) of intravenous~     (IV). To evaluate the pharmacokinetics and immunogenicity of ETI-204 after repeat IV~     administration.~   "
85960|NCT01932229|"~     Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal~     growth factor receptor) gene, which have disease progression after treatment with an EGFR~     inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment~     with chemotherapy will be recruited. The trial has only one arm, of afatinib daily~     treatment. Blood and exhaled breath samples will be collected for investigations aiming to~     identify factors that predict response to afatinib.~   "
85961|NCT01932216|"~     Prospective, randomized , multicenter study comparing cholecystectomy performed with da~     Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy~   "
85962|NCT01932203|"~     There may be a difference in efficacy of cilostazol and aspirin on progression of white~     matter changes in cerebal small vessel disease.~   "
85963|NCT01932190|"~     The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients~     with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter~     prospective randomized open-label trial to compare two strategies in ICU patients~     (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as~     RIFLE F classification. These patients will be randomly allocated to one of the following~     strategies:~        1. an early strategy where RRT is started immediately when a RIFLE F status is~          documented~        2. a delayed strategy where RRT (in patients who also present RIFLE F renal failure) is~          started only in case of occurrence of one or more of the following events (Alert~          Criteria): oliguria or anuria lasting for more than 72 hours after randomization,~          serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum~          potassium concentration > 5.5 mmol /L that persists despite well-conducted medical~          treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial~          pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context~          of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value,~          acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow>~          5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or~          noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.~      The primary endpoint is overall survival, measured from the date of randomization to the~     date of death, regardless of the cause. The minimum duration of each patient's follow-up~     will be 60 days.~   "
85964|NCT01932177|"~     EVESOR multiparameter phase I trial aims at determining the safety of different doses and~     dosing schedules of everolimus in combination with sorafenib as well as the recommended~     doses & dosing schedules for phase 2 trials in adult patients with advanced solid tumors.~   "
85965|NCT01932164|"~     The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar~     bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous~     dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®)~     through prospective qualitative and quantitative analysis of bone neoformation.~   "
85966|NCT01932151|"~     Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced~     cirrhosis characterized by marked renal failure and is associated with a very poor~     prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur~     spontaneously. It has been demonstrated that vasoconstrictor agents plus albumin are~     effective in the reversal of the renal failure. A large number of studies have shown that~     terlipressin improves renal function in patients with type 1 HRS; treatment is effective in~     50-75% of patients approximately. Currently there are no specific studies about the~     treatment of type-1 HRS with ongoing infections.~   "
85967|NCT01932138|"~     The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility~     and acceptability of an enhanced community health worker (CHW) intervention and outreach~     system to improve antenatal care and PMTCT uptake and retention, and to decrease~     mother-to-child HIV transmission.~   "
85968|NCT01932125|"~     This multicenter prospective observational study will evaluate the safety and efficacy of~     Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic~     epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be~     collected from eligible patients until death, withdrawal of consent, loss to follow-up, or~     study closure.~   "
85969|NCT01932112|"~     The investigators studied the effects of adenosine on the reconnection rate after successful~     pulmonary veins isolation by radiofrequency catheter ablation in patients with~     drug-resistant atrial fibrillation~   "
85970|NCT01932099|"~     A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve~     system. This is for people with severe aortic stenosis who are not well enough to undergo a~     surgical repair. The delivery of this device is done via the femoral artery.~   "
85971|NCT01932086|"~     This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical~     trial. The present study was carried out to compare the effects of white rice, brown rice,~     and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a~     white bread as a positive control.~   "
85972|NCT01932073|"~     Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of~     light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment~     modality based on the photochemical effect of light on tissues, which modulates various~     metabolic processes.~      LLLT has been used for a wide range of conditions, in particular in dermatology, to promote~     wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to~     assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation~     dermatitis), a very common and distressing side effect of cancer treatment.~   "
85973|NCT01932060|"~     Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to~     initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to~     maintain adequate uterine tone after delivery. The study investigators aim to compare two~     different infusion rates of oxytocin to assess the optimal infusion regimen for reducing~     blood loss in women undergoing elective Cesarean delivery.~   "
85974|NCT01932047|"~     ■ Unmet medical needs for Refractory cancer Conquest~      - Many advanced cancers are still detected Despite remarkable technological advances for the~     early diagnosis of cancer in the field last 20 years.~      In the type of progressive carcinoma is very high malignancy despite a variety of~     therapeutic target treatment for refractory cancer.~      The refractory cancer patients who main focus of this research defined as the adult solid~     tumor patients who have failed standard therapy according to the criteria~      NCCN / ASCO (American Society of imsangam) / KCSG (Study Group for chemotherapy).~      The survival rate of refractory cancer patients are estimated to be 30-40% of the total~     patients with metastatic solid tumors and these refractory cancers are~      difficult to deal with or control to conventional treatment so shows almost close to 100%~     mortality.~      Therefore the new development of therapies for conquer of refractory cancer are urgently~     required.~      ■ Preclinical translational research Unmet Needs of Bio-new drug development for conquer of~     refractory cancer~      - The stage of preclinical translational research (Translational Research) connects between~     the early stages of development and clinical trials in the stage drug development.~      The establishment of foundation based on the translational research is very necessary and~     this must have proven ability to treat refractory cancer.~      The most anti-cancer drugs developed by existing preclinical testing method actually does~     not show a remarkable effect in many cases in the clinical trials,~      even if showed a remarkable inhibitory cancer effect in animal testing.~      The exact molecular diagnosis to treat targets and paradigm for the development of new drugs~     at the same time requires for target treatment.~      The tailored cell lines by patients and the proven technology by animal models and unmet~     need for preclinical translational research is increasing~   "
85975|NCT01932034|"~     We will compare the percentage of patients having therapeutic vancomycin serum~     concentrations after current standard dosing, after dosing with our software. We will also~     include therapeutic outcomes and costs in the analysis.~   "
85976|NCT01932021|"~     The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It~     occurs in patients older than 60 years followed for hypertension. Clinical diagnosis~     requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia,~     cholesterol crystal emboli, vasculitis associated with hepatitis C, myeloproliferative~     disorders and ulcers associated with the Hydrea ® outlet.~      There is no treatment of the ulcer because conventional treatments are ineffective. The pain~     has subsided by analgesics III. Other treatments are not effective outside skin grafts to be~     repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients~     healed through autohemotherapy.~      Ineffective treatment of this painful condition and efficiency of these cells to the damaged~     tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous~     injections of autologous fat to change the wound bed, promote healing and eliminate pain.~     This treatment should help to avoid long-term hospitalization (about 15 days) that can lead~     to physical and psychological degradation of these elderly patients.~      The investigators propose an open clinical study of 10 patients with a single-center~     recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month~     recruitment and follow-up of 6 months for each patient.~      The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side~     effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of~     healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3~     months wound. The measure of effectiveness will also focus on the changing appearance of the~     wound, including the relative areas of fibrin, necrosis and budding. These efficiency~     measures (area ratio) will be done through a computer program (CANVAS ®) on photographs~     taken at each assessment time.~      Eventually, if this study was to demonstrate the effectiveness of this treatment~     lipofilling, it would be possible to perform a multicenter study on a large number of~     patients to demonstrate the effectiveness, in terms of wound healing that the pain it causes~     and offer a shorter hospital stay, and in parallel, this approach should improve the~     pathophysiology of ulceration (translational research).~   "
85977|NCT01932008|"~     The purposes of this study are: (1) to compare the body composition, physical activity,~     physical function, and quality of life between patients with and without CKD after CABG; and~     (2) to analyze the relationships among body composition, physical activity, and physical~     function in this population. It is expected that patients after CABG with CKD have the worse~     body composition, physical function, and quality of life than patients after CABG without~     CKD; and patients with higher physical activity levels have the better body composition,~     physical function, and quality of life.~   "
85978|NCT01931995|"~     This research study is being done to gain a better understanding about brain networks that~     may be involved in depression. The investigators plan to examine how these networks change~     after the brain is stimulated with Transcranial Magnetic Stimulation (TMS). TMS is a way~     of stimulating the brain in order to mildly activate or mildly suppress different brain~     areas, and is used to treat some forms of depression. It is hoped that this study will~     facilitate learning more about the structure and function of different brain areas and the~     ways that they are interconnected to form networks, both in depressed people and in people~     without depression. In this research study, the effects of TMS will be measured by obtaining~     pictures of the brain with Magnetic Resonance Imaging (MRI) and with Positron Emission~     Tomography (PET). More specifically, this will be accomplished with a combined MRI and PET~     scanner, which is capable of simultaneously obtaining both MRI and PET images of the brain.~     This scanning paradigm will allow the assessment of local metabolic changes resulting from~     TMS (with PET images) and brain network changes resulting from TMS (with fMRI). Changes~     resulting from TMS between 20 subjects with depression and 20 healthy volunteers will be~     calculated and will form the main outcome measure.~   "
85979|NCT01931982|"~     The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion~     in the heart of patients with type 2 diabetes~   "
85980|NCT01931969|"~     This study is planned to compare right internal jugular vein catheterization entry points~     determined by ultrasound and the central landmark guided method, and the relationship of~     each with sternocleidomastoid muscle length and body mass index.~   "
85981|NCT01931956|"~     Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve~     Repair System in the treatment of mitral valve regurgitation. Clinical follow-up at~     discharge, 30 days, 6 months, 12 months, and 2-, 3-, 4-, and 5-years. The study consists of~     two arms: a high risk group and a non-high risk group. Enrollment in high risk arm is~     ongoing. Enrollment in non-high risk arm concluded in April 2011.~   "
85982|NCT01931943|"~     Brief Description:~      This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate~     Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients~     with advanced breast cancer.~   "
85983|NCT01931930|"~     In the current study the effects of proprietary Perilla frutescens leaf extract in~     comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on~     gastrointestinal discomfort and bowel function were investigated. The study was performed~     double-blind and placebo-controlled with a 4 week intervention period. Study products were~     taken two times daily (each one capsule before breakfast and dinner).~   "
85984|NCT01931917|"~     The purpose of the pilot study is to examine the effects of the Incredible Years Baby~     Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for~     parents with infants aged 0-12 months.~   "
85985|NCT01931904|"~     The purpose of this study is to determine if lowering the pressure inside the eye improves~     blood flow to the eye.~   "
85986|NCT01931891|"~     Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity~     an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not~     known, complex pathophysiologic pathways and mechanisms have been described.~      New blood vessels evolve during angiogenesis and vasculogenesis, two physiological~     processes, that play a crucial role in embryogenesis and placentation. Structural~     alterations in the human umbilical cord, maternal spiral arteries can cause adverse fetal~     consequences.Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the~     umbilical cord. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans~     in comparison to control tissue.~      Matrixmetalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various~     components of the extracellular matrix (ECM). A Disintegrin And Metalloproteinases (ADAMs)~     and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix~     Metalloproteinases (MMPs). Dysregulation of ADAMs and ADAMTS expression have been reported~     in different types of pathologies such as cancer, osteoarthritis, neurodegenerative~     inflammation or asthma.~      The role of ADAMTS in the pathomechanism of pre-eclampsia has not been studied until now. We~     therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from~     newborns of mothers with pre-eclampsia with those with normal pregnancy.~   "
85987|NCT01931878|"~     The purpose of this research study is to compare the safety and effectiveness of local~     injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a~     medical condition called Restless Leg Syndrome. This study has a double blind cross over~     design. Cross over means that you will have two sets of injections. The first set of~     injections can be either Xeomin or placebo. The order of injection will be reversed at the~     three month point following the first injection. Double blind means neither the~     investigators nor you know which one of the two (Xeomin or placebo) you received.~   "
85988|NCT01931865|"~     The purpose of this research study is to investigate the safety and effectiveness of~     botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of~     radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection~     of incobotulinum toxin A into an area of local pain, at or around the area of a~     post-surgical/post radiation scar, relieves the focal cancer pain.~   "
85989|NCT01931852|"~     The broad, long-term objective is to improve outcomes by optimizing healthcare delivery~     processes for patients with detectable to elevated serum troponin. This clinical trial~     involving emergency department (ED) patients with intermediate to high-risk chest pain and~     detectable to minimally elevated serum troponin within 6 hours of evaluation.~   "
85990|NCT01931839|"~     The purpose of this study is to evaluate the efficacy and safety of long-term treatment with~     lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.~   "
85991|NCT01931826|"~     Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in~     patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account~     the endemic nature of schistosomiasis mansoni in our region and the high morbidity and~     mortality directly associated with rupture of esophageal varices and UGIB in affected~     patients, we conducted a prospective randomized trial in patients with schistosomiasis and a~     history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic~     treatment alone compared with the efficacy of sclerotherapy preceded by a surgical~     treatment: Esophagogastric devascularization with splenectomy (EGDS).~   "
85992|NCT01931813|"~     This project is the pilot step necessary to develop a system of vaccination~     pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for~     this challenge and case series analysis, with the use of linked medicoadministrative data~     for hospitalisations the reimbursement of healthcare costs. This linkage of~     medicoadministrative data is new in France. The example of the risk of hospitalisation for~     febrile convulsions in infants less than two years old following vaccination against~     diphtheria, tetanus and pertussis is given as the reference association. This choice is~     justified by the numerous publications over many years on the existence of this association~     (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses~     have been carried out to assess this risk, the results can be compared directly (Lancet~     1995). The study to determine whether the analysis tools are suitable for the data will be~     tackled at the following levels:~        -  Validity of the selection of cases from administrative records alone using coding based~          on the international classification of diseases ICD10~        -  Validity of the risk assessment. This methodology feasibility project must make it~          possible to identify the different potential problems. This is a prerequisite necessary~          for the systematic implementation.~   "
85993|NCT01931800|"~     -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will~          be taken from the patient within 24 hours following inclusion (D0) in the department in~          which the patient is hospitalised~        -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will~          be taken from the patient every 7 days following inclusion for 5 weeks (if the patient~          is still in hospital at the time), in the department where he/she is hospitalised (D7,~          D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU,~          even if all of the samples have not been taken.~        -  For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose,~          and 1x5 ml tube with blue CTAD) will be taken following the same timetable.~        -  For hospitalised patients, a leeway of 48 hours is authorized for the sampling~          procedure. Samples will be taken at the same time samples are taken for the usual care~          of the patient.~        -  The tubes will be taken to the Bacteriology Laboratory using the usual collection~          circuit of the CHU. These tubes will then be redirected to the Infectious Diseases~          Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus~          pneumoniae isolated in the patient will be preserved at -80°C. If strains other than~          Streptococcus pneumoniae are isolated, these different strains will all be preserved at~          -80°C under the same identification number.~   "
85994|NCT01931787|"~     This pilot clinical trial studies CPI-613 (6,8-bis[benzylthio]octanoic acid) in treating~     patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the~     growth of tumor cells and may be an effective treatment for small cell lung cancer.~   "
85995|NCT01931774|"~     Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that~     may impair neurocognitive functions such as memory, attention, psychomotor speed, and~     executive functions, which are also common psychiatric disorders in patients with acne.~      The purpose of this study is to determine cognitive functioning in treatment naive acne~     patients, without a history of any psychiatric disorder.~   "
85996|NCT01931761|"~     To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose~     [14C] selumetinib in volunteers~   "
85997|NCT01931748|"~     The Purpose of this study is to evaluate in a randomized, double-blind, Parallel,~     Non-inferiority, Multicenter, the efficacy and safety of UNCNT in comparison to the active~     comparator of MELSMON in female having menopausal syndrome. Patients will be allocated~     randomly to receive either UNCNT or MELSMON.~      Through the injection of UNCNT to female having menopausal disorder, efficacy in the~     improvement of the menopausal symptoms by Kupperman index is to be evaluated and compared~     with MELSMON.~   "
85998|NCT01931735|"~     Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical~     procedures in the VA system. There remains substantial uncertainty, however, regarding the~     short term benefits and the long term consequences of arthroscopic meniscectomy in patients~     with degenerative meniscus tears. Of major concern is the fact that degenerative meniscus~     tears are associated with osteoarthritis, and it is known that within two years of surgery,~     arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and~     restoring function. Longer term, meniscectomy has been shown to be associated with elevated~     risk of osteoarthritis development, raising the concern that meniscectomy can actually be~     harmful. The purpose of this study is to determine whether meniscectomy in the setting of a~     degenerative meniscus tear is of any clinical value. Determining this would either justify~     the expenses associated with arthroscopic meniscectomy on a large number of patients, or~     would identify an area of significant potential cost savings.~   "
85999|NCT01931722|"~     Likely, branched chain amino acid (BCAA) requirements are increased in older~     strength-trained (ST) individuals. If so, supplementation in this group will maximize muscle~     protein synthesis (MPS) and minimize loss of muscle with age (sarcopenia).~   "
86000|NCT01931709|"~     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)~     and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response~     to treatment in patients with breast cancer. Comparing results of diagnostic procedures done~     before, during, and after chemotherapy may help doctors predict a patient's response to~     treatment and help plan the best treatment.~   "
86001|NCT01931696|"~     The purpose of this study is to assess whether acupuncture is effective in the treatment of~     chronic asthma.~   "
86002|NCT01931683|"~     The investigators attempted to determine the optimal effect-site concentration of~     remifentanil for smooth removal of the LMA from propofol anesthesia.~   "
86003|NCT01931670|"~     A randomized study evaluating the safety and efficacy of elagolix in the management of~     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.~   "
86004|NCT01931657|"~     Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea~     and reduce bleeding irrregularities during the initial months of Mirena use.~   "
86005|NCT01931644|"~     At Sanguine, we consider ourselves the bridge between patients and researchers striving to~     find new treatments and diagnostics for numerous medical conditions. We collect biospecimens~     like blood for medical researchers. Donate from your home, track your sample, and help~     advance medical research.~   "
86008|NCT01931605|"~     Background: Patients with indwelling urinary catheter for chronic retention due to~     obstructive BPH refractory to medical therapy are candidates for prostatectomy still~     considered as the gold standard of treatment. Urinary tract infection, strictures,~     postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss~     are complications associated with surgery. Minimally invasive treatments were originally~     conceived as an attempt to offer equivalent efficacy without the burden and risk of~     operative morbidity. Recently, it was suggested that prostatic arterial embolization (PAE)~     to treat BPH might follow uterine artery embolization for uterine leiomyomas. Animal studies~     in pigs and dogs have shown that PAE is safe and can induce prostatic volume reduction. The~     first report of this technique in the management of BPH in humans was by DeMeritt et al, who~     reported a single case of BPH with obstructive symptoms and blood loss refractory to other~     treatments that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.~      Objective : We investigate whether PAE might be a feasible procedure as an alternative~     treatment option to treat urinary retention due to obstructive BPH. The primary objective is~     to evaluate the success rate of procedure defined when selective prostatic arterial~     catheterization and embolization were achieve and patients can be able to urinate after~     their urinary catheter has been removed.~      Patients and methods : A monocentric prospective study is undertaken in 25 patients aged~     50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory~     to medical treatment with a clinical indication for surgery who agreed to undergo PAE. The~     study is approved by the hospital ethical committee and an informed consent form for PAE as~     an alternative treatment is signed by all participants.~      Statistical analysis : The sample size has been calculated in order to have an estimated~     probability of success (corresponding of primary objective) of 50% (worst case) with 95%~     confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used~     to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally,~     the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is~     indicative of statistically significant.~   "
86009|NCT01931592|"~     Rapid and rational health-care interventions are of great importance to efficiently combat~     the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a~     global level has been observed.~      For ESBL-E, effective eradication regimens are not yet available. The current study~     therefore aims to assess a new approach to ESBL-E eradication. To avoid administration of~     the eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study~     population will be restricted to immunocompromised high-risk patients.~   "
86010|NCT01931579|"~     Solitary pulmonary nodule has become a major challenge in respiratory clinical practice.~     According to published guidelines, their management often requires close CT follow up, PET~     CT and invasive procedures to obtain a definite histology. In this context, innovative~     endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for~     the localization and sampling of peripheral lung nodules. However, these techniques are~     unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal~     endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based~     confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of~     the distal lung structures in real time.~      This prospective trial we will assess confocal endoscopy as a tool to localize the~     peripheral lung nodules and to differentiate benign from tumoral lesions.~      Objective(s)~        1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy~          for the localisation of peripheral lung nodule~        2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors~      Experimental design:~      Multicentric prospective controlled trial, conducted in three academic centers, specialized~     in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based~     confocal endo-microscopy.~      Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored~     using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted~     in the same catheter as used for the navigational bronchoscopy and confocal images will be~     recorded before sampling. An ancillary study using topical methylene blue as in situ will be~     conducted at the Rouen University Center.~      An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal~     endo-microscopy analysis.~   "
86011|NCT01931566|"~     The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the~     risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also~     to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD~     in cognitively-normal participants who are at high-risk for developing MCI within 5 years.~   "
86012|NCT01931553|"~     Attending morning rounds take place at teaching hospitals every day. They are the primary~     mechanism for patient care delivery, supervision and education of trainees, and~     communication with patients, families, and staff. However, they are done with little~     standardization or widely recognized best practices.~      The objective of this quality improvement (QI) initiative is to evaluate the adherence to~     and impact of implementing standardized attending morning rounds on medicine teams at our~     institution. A standardized rounding intervention has been developed which includes specific~     guidance on completing the following activities during morning rounds: (1) Pre-rounds~     discretion; (2) Pre-rounds huddle; (3) Bedside registered nurse (RN) integration; (4)~     Patient-centered rounding; (5) Real-time order writing.~      This trial will randomize half of the investigators' medicine teams at University of~     California San Francisco to this rounding intervention whilst the other half will be~     randomized to continue with usual unstandardized rounding practices.~      The investigators will compare medicine teams randomized to undertake standardized rounding~     to those teams undertaking usual practice. Outcomes assessed will relate to the patient~     (e.g. satisfaction), providers (e.g. satisfaction), efficiency (e.g. total morning round~     time) as well as adherence to the intervention .~      The investigators' study hypotheses are that patient satisfaction scores will be higher for~     those patients receiving standardized bedside rounds compared to the usual care group. The~     investigators also hypothesize that total attending morning rounds time and interns length~     of workday will be shorter and that the number of consultations ordered before noon will~     increase for those teams undertaking standardized bedside. Further, the investigator~     hypothesize higher levels of nurse participation, physician and medical student satisfaction~     with standardized bedside rounding.~   "
86013|NCT01931540|"~     The prevalence of obesity in the developed world has increased markedly over the last 20~     years. Considering the prevalence of obese and overweight adult subjects, and the fact that~     pregnancy itself induces a state of insulin resistance and inflammation, maternal obesity~     may be the most common health risk for the developing fetus. It is well established that~     what we eat has a major impact on our health. However, there is growing evidence to suggest~     that diet during pregnancy and lactation may be particularly important as not only does it~     influence the health of the mother, it may have a permanent effect on the health of her~     children and even her grandchildren. The concept that environmental factors, such as~     nutrition during early development, influence both our health span and lifespan has been~     termed the developmental origins of health and disease hypothesis.~      The objective of the study are:~        -  to compare subjects with frailty (condition developed with ageing) with controls and~          characterize the unhealthy aged condition with the measurements described below~        -  to examine if signs of frailty can be reversed by lifestyle induced modifications~          (exercise training programme) of its primary components (IR, sarcopenia, psychological~          profile) in offspring of overweight/obese (OOM) vs lean mothers (OLM).~      The study consists of 37 frail old subjects, age ≥ 65 sub-grouped in 17 OOM, and 20 OLM and~     11 non frail controls. These subjects will be studied with positron emission tomography~     (PET), computed tomography (CT), magnetic resonance imaging (MRI) and spectroscopy (MRS) and~     ultra sounds (US). In addition functional MRI (fMRI) will be performed. Adipose tissue~     biopsies will be taken.~      Subjects will undergo characterization of biohumoral markers, a 75 g oral glucose tolerance~     test, imaging biomarkers (PET/CT, US, fMRI-MRS), genetic biomarkers (DNA and telomere~     damage) and inflammatory biomarkers (macrophage infiltration) before and after the 4-month~     lifestyle intervention period (physical exercise). By PET/CT it will be measured~     tissue-specific IR in skeletal muscle, adipose tissue, liver, myocardium and targeted brain~     regions. MRS will be used to measure organ steatosis in the skeletal muscle and liver, MRI~     will be used to measure fat masses in abdominal areas, and fMRI will be performed to assess~     activation in brain regions regulating cognition and appetite/energy control. US will be~     used to assess cardiovascular markers (IMT, strain and function).~   "
86014|NCT01931527|"~     The purpose of this study is to learn more about what is the effect of uric acid on~     oxidative stress and on the way the body metabolizes sugar in obese people. Understanding~     this may lead to better diseases such as diabetes.~   "
86259|NCT01928316|"~     The purpose of the study is to evaluate the bioequivalence (the way in which different forms~     of the same drug are absorbed in the body) of single-dose administration of domestic (made~     in China) mizolastine tablets and imported mizolastine tablets given at the same dose in~     healthy volunteers~   "
86015|NCT01931514|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable~     5mg tablet. Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
86016|NCT01931501|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5~     mg tablet. Dosing periods were separated by a washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
86017|NCT01931488|"~     The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic~     Denervation and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.~   "
86018|NCT01931475|"~     The purpose of this study is to assess the efficacy and safety of duloxetine once daily~     compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in~     participants in China.~   "
86019|NCT01931462|"~     Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney)~     tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the~     edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most~     common technique is to clamp the blood supply to the entire kidney during removal and to~     surgically repair the tumor bed with suture and agents to stop bleeding. This stops the~     blood supply to the entire kidney including the healthy tissue, which can cause damage to~     the remaining tissue due to a shortage of oxygen if left clamped too long.~      This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a~     bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping~     the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If~     adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading~     to the remaining tissue, clamping and a shortage of oxygen can be avoided.~      The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage~     of bleeding during partial kidney removal.~   "
86020|NCT01931449|"~     The purpose of this study is to evaluate the validity and safety of a modified operative~     procedure of digestive tract reconstruction following pancreatoduodenectomy which enables~     the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at~     gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of~     post-surgical pancreatic leakage and preserve the patients' digestive function as well.~   "
86021|NCT01931436|"~     This study will investigate the pharmacokinetics of single and multiple doses of Qing'E~     pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood~     such as psoralen and Isopsoralen will be detected.~   "
86022|NCT01931423|"~     To determine whether early placental drainage plus cord traction reduces the incidences of~     manual removal and blood loss, and to determine the risk factors associated with blood loss~     after delivery.~   "
86023|NCT01931410|"~     The investigators hypothesis in this study is that administration of rectal and sublingual~     misoprostol decreases intrapartum and postpartum haemorrhage.~   "
86024|NCT01931397|"~     Kidney transplantation is the treatment of choice for kidney failure in children. Kidney~     transplant recipients need to take immunosuppression for the rest of their lives after~     transplantation to prevent rejection of the graft. One of the important medications is~     called Tacrolimus which can prevent rejection of the kidney graft but at the same time is~     toxic to the kidney. Therefore, repeated blood levels of Tacrolimus with tests of kidney~     function will help physicians to prescribe the best dose for therapy to prevent kidney~     rejection and kidney toxicity. Failure of compliance with taking Tacrolimus is also an~     important cause of graft failure especially among teenagers, so repeated blood Tacrolimus~     levels are necessary to detect patients who fail to take their medications on a regular~     basis. We have developed a lab assay that measures Tacrolimus blood level and creatinine~     (for kidney function) using one dried blood spot (DBS) on filter paper similar to the filter~     paper used in the new born screen. We plan to teach patients how to do the test at home once~     a month and mail the filter paper back to OHSU for analysis for Tacrolimus and creatinine.~     The advantage of this method is that it is less painful for children then a regular blood~     dray from the vein, can be done easily at home, will be most cost effective as it will save~     the family a day of work or school and can detect both the Tacrolimus level and the kidney~     function at the same time.~      We will assess the effect of doing this simple finger prick at home on compliance, on~     Tacrolimus levels and kidney function over the study period of one year. We will also assess~     how satisfied patients are with this method instead of going to the lab or the hospital for~     blood test. All subjects will continue on their regular clinic visits and will continue to~     have their routine blood draws by intravenous method in the lab during the study.~   "
86025|NCT01931384|"~     A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer~     cycles.~      The hypothesis of the study is that the use of luteal phase support with human chorionic~     gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.~   "
86026|NCT01931371|"~     The purpose of this study is to determine whether anal fistula plug or endorectal~     advancement flap is more successful in the treatment of anal fistulas and compared both~     procedures with regards to cost.~   "
86027|NCT01931358|"~     The primary purpose of the study is to better define the relative contributions of AIDSVAX®~     B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed~     immune profile in the weeks and months after receiving the original prime and boost vaccine~     regimen from study protocol RV 144, and their booster effects in both the systemic and~     mucosal compartments. In addition, this study will provide more intensive and comprehensive~     characterization of the innate, cell-mediated and humoral immune responses than possible~     within the RV 144 study.~   "
86028|NCT01931345|"~     In 2009, a team of researchers from Montreal, Canada, implemented SPOT, an intervention~     aimed at reducing HIV transmission among men who have sex with men by offering rapid HIV~     testing in a community setting. During the first phase, counseling based on Quebec~     guidelines for rapid HIV testing was offered (standard counseling - SC) and in the second~     phase, counseling based on motivational interviewing (MIC) was developed and validated. The~     current phase of the project aims to strengthen the work undertaken during previous phases.~     The objective of the study is to assess the short and medium term effect of MIC on the~     occurrence of at-risk anal intercourse and its cognitive determinants. Participants will be~     randomly assigned to either SC or MIC, and will respond to a baseline questionnaire~     documenting their sexual behavior and psychosexual profile prior to the intervention at the~     start of their initial visit (T0). The effect of counseling will be assessed following the~     intervention at the end of the initial visit (T1), at 3 months after the initial visit (T2)~     and at 6 months after the initial visit (T3).~   "
86029|NCT01931332|"~     Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early~     post-operative pain. The primary aim of this study was to investigate the impact of either a~     single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain~     after TKA~      The Null Hypothesis is that there is no difference in the post operative pain relief~     provided for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal~     diamorphine (ID).~   "
86030|NCT01931319|"~     The objective of this study is to determine safety and characterize pharmacokinetics of~     higher doses of intravenous baclofen in healthy subjects.~      This study is a non-randomized dose escalation study. Three subjects will receive 10 mg~     doses of IV baclofen, two or more days later the next three subjects will receive 15 mg~     baclofen intravenously, and two or more days later the last three subjects will receive 20~     mg IV baclofen.~      The pharmacokinetic and tolerability information gained from this study will support the~     development of further studies to assess the use of IV baclofen to prevent or treat baclofen~     withdrawal syndrome.~   "
86031|NCT01931306|"~     To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib~     in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring~     Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR~     tyrosine kinase inhibitor (TKI)~   "
86032|NCT01931293|"~     Patients with atrophic glossitis (AG) or burning mouth syndrome (BMS) are frequently~     encountered in the oral mucosal disease clinic. Our previous studies found a significantly~     higher frequency (26.7%) of serum gastric parietal cell antibody (GPCA) and a significantly~     higher frequency (31%) of serum thyroglobulin antibody (TGA) or thyroid microsomal antibody~     (TMA) in AG patients than in healthy control subjects. Moreover, there is also a~     significantly higher frequency (13.3%) of serum GPCA or a significantly higher frequency~     (23.5%) of serum TGA or TMA in BMS patients than in healthy control subjects. Because~     patients with one organ-specific autoantibody are prone to have another organ-specific~     autoantibody in sera, we also evaluated whether AG or BMS patients with GPCA are prone to~     have TGA or TMA in sera and vice versa. We further found that 25.3% of TGA- or TMA-positive~     AG or BMS patients also have GPCA, 32.3% GPCA-positive AG or BMS patients also have TGA, and~     30.6% GPCA-positive AG or BMS patients also have TMA in their sera. Without proper diagnosis~     and treatment, patients with GPCA are more likely to develop autoimmune atrophic gastritis~     and subsequently progress to gastric carcinoma, and patients with TGA or TMA may develop~     autoimmune thyroid disease and finally result in thyroid dysfunction. In addition, previous~     studies have shown a close association of the HLA-DR or HLA-DQ loci with the presence of~     autoantibodies (such as GPCA, TGA or TMA) in patients with different types of autoimmune~     disease. Therefore, in the following 3-year research project, we plan to collect 300 AG and~     450 BMS patients from the oral mucosal disease clinic of Department of Dentistry, National~     Taiwan University Hospital. For each year, 100 AG and 150 BMS patients are collected. A~     10-cc blood sample will be drawn from each patient, with 5 cc being used for the~     determination of the serum levels of GPCA, TGA and TMA and another 5 cc being used for the~     HLA-DRB1 and HLA-DQB1-genotyping using the polymerase chain reaction with sequence-specific~     primer (PCR-SSP) typing technique. At the end of this 3-year study, we will realize the~     frequencies of presence of GPCA, TGA and TMA in sera of our 300 AG or 450 BMS patients.~     After statistical analyses, we will also know which specific HLA-DRB1 or HLA-DQB1 allele and~     which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA, TGA or TMA in~     sera of our AG or BMS patients. In addition, we will understand which specific HLA-DRB1 or~     HLA-DQB1 allele and which specific DRB1-DQB1 haplotype are responsible for the possession of~     GPCA in TGA- or TMA-positive AG or BMS patients as well as for the possession of TGA or TMA~     in GPCA-positive AG or BMS patients. With this important information in mind, we can predict~     the development of the specific autoimmune diseases such as autoimmune atrophic gastritis~     and autoimmune thyroid diseases and then adopt proper early diagnosis and treatment to~     prevent the future occurrence of these diseases and their potential complications (such as~     gastric carcinoma or thyroid dysfunction).~   "
86033|NCT01931280|"~     This study includes a behavioral educational intervention that focuses on healthy eating,~     physical activity and glucose management during pregnancy and post partum among women newly~     diagnosed with gestational diabetes mellitus (GDM).~   "
86034|NCT01931267|"~     The purpose of this 4-year study is to investigate the relationship between cognition and~     learning ability on patients with COPD during hospitalization to establish and evaluate the~     effects of the community-extended discharge planning program. The transition theory is used~     as the theoretical base in this study. The patients with diagnosis of COPD in hospital will~     be invited to participate. The data of demographic variables, the cognitive function¸ the~     respiratory function, the effect of learning and the usage of medical resources after~     discharged will be collected. In the first year, we will establish the protocol of~     respiratory teaching in two modes, and to compare the differences among computer interaction~     game intervention, face to face teaching and routine nursing intervention, also to evaluate~     the related factors and the effect of learning on patients with COPD for determining the~     needs of patients' learning mode and the optimal frequency of nursing teaching mode during~     hospitalization in the second year. For the second year, build upon the results of the first~     year, the preliminary draft of the community-extended discharge planning program that base~     on the experts' meeting and the interview with the patients. Also, a pilot study that~     revising the content and testing the feasibility of respiratory teaching protocol will be~     conducted. For the 3rd and 4th year, using case-control RCT design, the community-extended~     discharge planning program will be tested in patients during their hospital stay and~     post-discharge period. The effects of this community-extended discharge planning program~     will be evaluated on outcome variables of patients' cognitive learning function, utilization~     of health care resources. The results of this study will help to develop a~     community-extended discharge planning for patients with COPD on cognition level and learning~     ability. Furthermore, the protocol of the community-extended discharge planning will serve~     as references to prolong the development of disease deterioration, reduce the probability of~     readmission and improve the quality of life.~   "
86035|NCT01931254|"~     In the past 70 years antibiotics have served as the first line of defense against infectious~     diseases. However, antibiotics are only effective against bacterial infections and are not~     the solution for infections caused by viruses such as common colds or flu. Despite their~     contribution to healthcare, antibiotics are currently recognized as the most misused drugs~     in the world with global overuse estimated at 40%-70%, mostly due to the ineffectiveness of~     current diagnostic solutions to distinguish between bacterial and viral infections.~     Antibiotics misuse often causes preventable adverse events that impact patient care and lead~     to the emergence of antibiotic-resistant bacteria, one of the major threats to global health~     today. To address these challenges, MeMed has been developing the ImmunoDx™, a novel~     technology that relies on the best available detection system for differentiating between~     viruses and bacteria - the body's own immune system. The ImmunoDx™ technology employs a~     simple blood test that provides the physician, within two-hours, the information he needs to~     decide whether to treat the patient with antibiotics or not. This technology has been tested~     on over 1000 patients of different ages and diseases and was found to be highly accurate and~     safe. The current study is a non-interventional study and the participants do not receive~     any investigational drug nor any experimental examination or procedure. Therefore, the~     collected data in this study will not affect the diagnosis, prognosis, or treatment of the~     participants. Participation includes the collection of a teaspoon of blood and collection of~     a specimen using a nasal swab. These procedures are common in the clinical practice and are~     widely performed and possess no significant risk. By participating in the study, the~     subjects impact the development of the ImmunoDx™ technology, which is expected to enable a~     future faster and more accurate diagnosis of infectious diseases as well as more appropriate~     prescription of antibiotics. This will open the way to improve treatment decisions in~     millions of patients around the world.~   "
86036|NCT01931241|"~     Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL~     cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque~     burden.~   "
86037|NCT01931228|"~     Respiratory failure after extubation is a relevant consequence of poor airway clearance due~     to respiratory muscle weakness and respiratory failure after extubation and reintubation is~     associated with increased morbidity and mortality.~      the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in~     Preventing Respiratory Failure After Extubation as compared manually assisted coughing~   "
86179|NCT01929499|"~     It has been reported that the immune status of patients with cancer were suppressed,~     especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease~     the recurrence rate after surgery. CIK cells transfusion has been reported as an effect~     therapy in advanced cancers. In another retrospective study, investigators found that~     adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer~     patients.~      The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in~     patients with colon cancer after operation will prolong DFS, and overall survival (OS).~   "
86038|NCT01931215|"~     Analgesia after cesarean section is still not satisfactory for many women. Even if pain~     reduction is sufficient with the technique of intrathecal morphine injection, side effects~     such as nausea and pruritus are common.~      Since several years, an alternative technique has been studied, the transversus abdominis~     plane (TAP)-block. Here a local anesthetic is injected in the abdominal wall muscles, and~     this has been shown to give a similar analgesic effect compared to intrathecal morphine,~     with potentially less side effects.~      With this study, we want to evaluate if the TAP-block yields indeed less side effects when~     compared with intrathecal morphine.~      The study will be a prospective study with the patients randomized to either a group with~     intrathecal morphine or a group with TAP-block.~   "
86039|NCT01931202|"~     This project seeks to elucidate the mechanisms by which antidepressant medications have~     limited efficacy in Late Life Depression (LLD) in order to develop new treatment~     interventions for this prevalent and disabling illness. We hypothesize that the presence of~     executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability~     to form appropriate expectancies of improvement with antidepressant treatment. Greater~     expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to~     be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on~     magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy~     controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and~     decrease the efficacy of antidepressant medications by disrupting connections between~     prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter~     tracts may also compromise the pathway by which expectancy-based placebo effects influence~     depressive symptoms. Expectancies reflect activation in PFC areas that may improve~     depressive symptoms by modulating the activity of subcortical regions subserving negative~     affective systems (i.e., amygdala) as well as those important in reward and hedonic capacity~     (nucleus accumbens and ventral striatum). Thus, LLD patients withED and WMH may sustain a~     double-hit to their ability to experience placebo effects in antidepressant treatments: ED~     diminishes the ability to generate appropriate treatment expectancies, while WMH disrupt the~     physiologic pathways by which expectancies lead to improvement in depressive symptoms.~   "
86040|NCT01931189|"~     The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and~     infliximab(the comparator) in Japanese healthy volunteers~   "
86041|NCT01931176|"~     Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this~     study is to evaluate the safety and immune response to a dengue virus vaccine.~   "
86042|NCT01931163|"~     RATIONALE: Everolimus plus Cisplatin may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: The purpose of this study is to test how effective combing a Cisplatin chemotherapy~     with Everolimus is in treating subjects with residual triple negative breast cancer, who~     have already received chemotherapy prior to surgery.~   "
86043|NCT01931150|"~     The purpose of this study is to see if the investigators can prevent or reduce the severity~     of the Cetuximab-related acne rash. Two different topical agents will be applied to the~     skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel~     is an FDA approved medication that you apply to the face. It is commonly used to treat acne.~     Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition~     to these topical agents they will be given a pill to take once a day. This pill has already~     been shown to help fight rashes from Cetuximab.~   "
86044|NCT01931137|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet~     formulation with three different coatings in healthy subjects.~   "
86045|NCT01931124|"~     Aim of the study is to investigate the effect of different types of training (high intensity~     and moderate training) on maximal oxygen uptake and activity levels in an elderly Norwegian~     population after one year training intervention. Baseline data include the activity levels~     assessed through self reported means as well as objectively measured activity data using~     activity monitors.~   "
86046|NCT01931111|"~     This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to~     find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which~     cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.~   "
86047|NCT01931098|"~     Background:~      Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug~     pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat~     lung cancer. Both topotecan and pazopanib have individually been used to treat patients with~     glioblastoma and some anti-tumor activity has been found. Researchers want to see if these~     two drugs together may be able to help people with glioblastoma.~      Objectives:~      To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the~     safety of this drug combination.~      Eligibility:~      Adults at least 18 years old whose glioblastoma has returned after treatment.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants~     lay in a machine that takes pictures.~      Chest CT scan or x-ray~      Heart electrocardiogram (EKG)~      A questionnaire about quality of life~      Participants will be assigned to a study group.~      Participants will take the study drugs for 28-day cycles for up to 1 year. They will take~     capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth~     once every day.~      Participants will write in a diary the times they take the study drugs.~      Participants will have several study visits during each cycle. These may include~      Blood pressure measurement~      Blood and urine tests~      EKG~      Physical exam and/or neurological exam~      Brain MRI or CT scan to check the status of the disease~      A symptom questionnaire~      At the end of treatment, participants will have a physical exam. They may have blood drawn.~      Participants will have follow-up calls once every 3 months to check.~   "
86180|NCT01929486|"~     The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T~     cell depletion with Mogamulizumab for advanced or recurrent cancer patients.~   "
86048|NCT01931085|"~     Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary~     practice. Triclabendazole is considered to be a second-line drug for parasites and is used~     when other preferred agents cannot be used because they are ineffective or because adverse~     reactions limit their use. Although Triclabendazole is widely used in developing countries~     for the treatment of parasites it is not approved by the FDA for this treatment in the US.~     It is currently being distributed in the US through a special arrangement with the FDA and~     the manufacturer on an individual patient approval basis. This arrangement requires that a~     single patient Investigational New Drug (IND) be obtained from FDA for each patient~     requiring Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the~     drug directly to the prescribing physician.~   "
86049|NCT01931072|"~     The purpose of the study was to investigate whether regular moderate- or high-intensity~     interval training can change the DNA methylation in a long-lasting state, and whether these~     changes affect the gene expression. In addition, the investigators will determine whether~     the intensity of the training could be an affecting factor of the possible DNA-methylation~     change as well. The null hypothesis was that no such exercise-induced changes occur.~   "
86050|NCT01931059|"~     To detect functional correlation changes in the brain with anti-psychotic drug~     administration as compared to placebo, and b.) to measure if these changes correlate with~     the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug~     induced symptoms and changes in cognitive function.~   "
86051|NCT01931046|"~     The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3~     in subjects with localized prostate cancer.~   "
86052|NCT01931033|"~     This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a~     treatment for social impairment in adolescents with autism spectrum disorders (ASD). We~     hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving~     the core symptoms of autism spectrum disorders in adolescents ages 11-17.~   "
86053|NCT01931020|"~     RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more~     efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature~     infant pain profile)~   "
86054|NCT01931007|"~     The overall goal of this study is to develop regenerative cell therapy for use in patients~     with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study~     that assesses the safety and feasibility of using concentrated bone marrow aspirate~     containing MSC to treat patients with painful knee OA.~   "
86055|NCT01930994|"~     A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years~     of used and Jadelle during five years of use by Kenyan women.~   "
86056|NCT01930981|"~     We are interested in studying whether and how medical problems other than primary cancer~     before hematopoietic cell transplantation would impact the profiles of quality of life and~     toxicities post-transplantation for patients with blood cancers. We want to see if by~     assessing comorbidities (such as diabetes) early on, we can identify those patients who will~     have more toxicities or limitations in their quality of life after transplant. The generated~     information could set the stage for future intervention studies aiming to improve quality of~     life for patients with blood cancers after transplantation.~   "
86057|NCT01930968|"~     The hypothesis is that microbubbles may be used as a contrast agent to help image tumors in~     the eye. In this study, patients with eye melanoma who are going to have their eye removed,~     will have their eye imaged by ultrasound (sound waves) before and after intravenous~     injection of microbubbles. The pathology characteristics of the tumor in the removed eye~     will be compared with the images.~   "
86058|NCT01930955|"~     Some acute upper respiratory tract infection(AURI) in children is characterized by fever and~     vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC)~     usually increased in this children patients,hence antibiotics are often prescribed properly~     assumed. In the present study, it was hypothesized that it was not necessary to prescribe~     amoxicillin for the children.~   "
86059|NCT01930942|"~     The aim of this study is to find some genetic factors in predicting the sensibility of~     preoperative chemoradiotherapy for locally advanced rectal carcinoma.~   "
86060|NCT01930929|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and~     greater extent as treatment of obesity to obtain a greater and more permanent weight loss.~     The currently most commonly used surgical method is the gastric bypass (RYGB), which so far~     has proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of~     complications.~      To enlighten this we will conduct a cohort study of complications by investigating~     hospitalizations and deaths after RYGB. Moreover we will get an overview on medication use~     before and after RYGB operation in the Central Denmark Region and in the North Denmark~     Region 2006-2011 (about 5000 patients).~   "
86072|NCT01930760|"~     The proposed study is a randomized control trial evaluating the efficacy of two training~     programs in increasing physician identification, documentation, and motivation of overweight~     children. Pediatric primary care physicians will be recruited from the College of Physician~     and Surgeons of Ontario and randomized into two practice-based interventions~     (behavioural/educational) which are a one-time training attendance. The educational~     intervention will focus on the medical management of pediatric obesity, the use of Body Mass~     Index charts, and information about how obese children would like to be approached by their~     physicians. The behavioural intervention will incorporate Motivational Interviewing tools in~     addition to an abbreviated training program received by the educational intervention group.~   "
86181|NCT01929473|"~     Serum samples will be corrected twice from the same youth subjects with one year interval.~      Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from~     an identical individual.~      The relationship between the incidence and the demographic data or medical history of the~     subjects will be discussed.~   "
86061|NCT01930916|"~     Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the~     treatment of thromboembolic disorders, which are among the most costly diseases in terms of~     public health resources. According to the Agence française de sécurité sanitaire des~     produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients~     treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of~     many adverse effects, given their narrow therapeutic window. They are the cause of the death~     of approximately 5000 patients per year. The use of this therapy is a priority axis of~     reflection for the Haute Autorité de Santé.~      The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people,~     is particularly affected by this problem.~      University hospitals of our interregion, given their very substantial regional referral~     activity, are actually involved in managing VKA adverse side effects.~      Elderly population constitutes the majority of prescriptions. The main objective of this~     study is to compare INR of people older than 75 years measured by traditional method with~     those measured by capillary method with INRatio2 supply.~      The secondary objective is to show that this measure is not affected by the presence or~     absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as~     to test the variability of INR measurement between different hospital.~   "
86062|NCT01930903|"~     The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not~     possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug~     Eluting Balloon.~   "
86063|NCT01930890|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB023 in participants with lupus nephritis (LN).~   "
86064|NCT01930877|"~     Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the~     patient. The investigators seek to determine if the addition of systemic lidocaine can~     improve the quality of recovery after spine surgery and reduce the requirement for opiate~     therapy.~   "
86065|NCT01930864|"~     MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.~   "
86066|NCT01930851|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and~     greater extent as treatment of obesity to obtain a greater and more permanent weight loss.~     The currently most commonly used surgical method is the gastric bypass (RYGB), which so far~     has proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of~     complications.~      To enlighten this we will conduct a questionnaire survey of complications such as pain,~     dumping and hypoglycemia after RYGB. Moreover we will the quality of life after RYGB~     operation. We will invite 3500 RYGB operated patients the Central Denmark Region who have~     been operated 2006-2011.~   "
86067|NCT01930838|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and~     greater extent as treatment of obesity to obtain a greater and more permanent weight loss.~     The currently most commonly used surgical method is the gastric bypass (RYGB), which so far~     has proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of~     complications.~      To enlighten this the investigators will conduct a clinical trial concerning complications~     after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark~     Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will~     be possible to give a good estimate of the incidence of medical complications. The~     investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve~     problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin~     deficiencies that may be identified through blood tests. A control group of 30-40 age, sex~     and body mass index matched individuals will go through the same examinations.~   "
86068|NCT01930812|"~     The purpose of this study is to compare, in patients with prostate or breast cancer, the~     accuracy of 18F-NaF PET imaging to 99mTc whole body bone scans with single-photon emission~     computed tomography (SPECT).~   "
86069|NCT01930799|"~     This study will assess the impact of a systematic bladder health screening and disease~     education regimen as well as the implementation of a referral process on the quality of life~     of multiple sclerosis patients with bladder dysfunction.~   "
86070|NCT01930786|"~     This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in~     clinical practice. Treatment will be administered in accordance with physician standard~     practice. All treatment decisions lie with the physician.~   "
86071|NCT01930773|"~     Patients undergoing percutaneous coronary intervention with a residual high platelet~     reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The~     strategies to overcome the issue consist of switch to a more potent antiplatelet medications~     including prasugrel or ticagrelor. Economic constrains of many countries still do not allow~     wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise~     treatment according to genotype and phenotype characteristics of the patient may provide an~     attractive solution combining high clinical efficacy with low budget impact.~   "
86073|NCT01930747|"~     The objective of this study is to compare the value of deep neuromuscular block (NMB) (using~     rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 mean alveoalr~     concentration (MAC) inhalation (using sevoflurane) for the surgeon.~      The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus~     opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and~     the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points~     allow to calculate the abdominal compliance and the PV0.~   "
86074|NCT01930734|"~     Heart failure (HF) is a prevalent disease reaching 1-2% of adult population in developed~     countries, and 10% in patients over 70 years. In the past HF patients had a 5-year mortality~     rate of 60-70% of HF with high rate of hospitalization and disability leading to a HF~     epidemic. Treatment improvements in the past decades have significantly reduced~     hospitalization and mortality. However, there is an increasing subset of patients (>10%)~     with advanced HF symptoms (functional class III/IV) for whom current management strategies~     are limited and do not provide a significant improvement in morbidity, mortality and quality~     of life.~      Specialized HF clinics, implementing a comprehensive therapeutic approach, were suggested to~     be beneficial in this population. However, the design of these clinics is variable with~     different methods of follow-up, therapy and supervision. Intermittent infusions of~     dobutamine were previously inconclusive regarding symptom alleviation and hemodynamic~     improvement and raised a concern of increased mortality in HF patients. Furthermore, the~     evidence scope is narrow since most trials including inconsistent and relatively high~     dobutamine dosages. Accordingly, current guidelines do not provide specific recommendations~     for dobutamine therapy in stable HF patients, and indication for treatment are limited for~     acute HF with hypotension and signs of hypoperfusion, or alleviation of symptoms in severely~     symptomatic patients in stage D HF.~      The primary aim of the proposed study is to evaluate the impact of intermittent low-dose~     dobutamine infusion on clinical and hemodynamic parameters in advanced HF patients treated~     in a tertiary heart failure clinic in the setting of a randomized clinical trial. We~     hypothesize that intermittent therapy with low-dose dobutamine will be associated with~     improved functional capacity and quality of life among patients with advanced heart failure,~     thereby providing evidence for beneficial effects of a potentially important therapeutic~     regimen in this high risk population.~   "
86075|NCT01930721|"~     The angle at which an episiotomy can be made is a continuous variable. If the investigators~     consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90~     degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.~   "
86076|NCT01930708|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) in~     participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with~     dimethyl fumarate (DMF) over a 12-month period.~      The secondary objectives of this study in this population are to assess the impact of DMF~     over a 12-month period on participants -reported health-related quality of life (HRQoL)~     outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes,~     and to characterize participants-reported adherence to DMF.~   "
86077|NCT01930695|"~     The study is designed to collect data of the performance and confirm the safety of the DX~     (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent~     atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX~     functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected~     to the LinoxSMART S DX right ventricular lead. The combination of these devices enable~     atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number~     of implanted leads without sacrificing atrial information. Atrial pacing can not be provided~     but is not needed in patients with permanent atrial fibrillation.~   "
86078|NCT01930682|"~     The primary objective is to demonstrate efficacy on epicardial and myocardial reperfusion of~     fibrinolytic treatment with alteplase followed by early routine catheterisation or rescue~     coronary intervention in Chinese population and to evaluate safety of alteplase fibrinolytic~     therapy followed by routine catheterisation or rescue coronary intervention in Chinese~     population.~   "
86079|NCT01930669|"~     The purpose of this study is to measure the dysfunction of the autonomic nervous system in~     modulating the heart rate variability and baroreflex control in critically ill.~   "
86080|NCT01930656|"~     Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available~     online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests~     using the American high risk cut-points for considering treatment but also suggests deriving~     domestic cut-points from cost-effective approach. Establishing cost-effective domestic~     cut-points for policy suggestions coupled with mobile devices with wireless access would~     potentially increase the usage of FRAX® tool.~      Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2)~     To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis~     diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.~      Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search~     Pubmed and international osteoporosis guidelines to better understand the clinical~     applications of FRAX® in other countries. Investigators will also search epidemiological~     data for osteoporosis, facture, quality of life and cost to establish domestic~     cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations~     from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A:~     geriatric health exam clinics with American cut-points, group B: orthopedic clinics with~     translational approach cut-points and group C: endocrine clinics with cost-effectiveness~     cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a~     trained research assistant during clinic waiting periods to screen and enroll high risk (75~     from each clinic) adults with informed consents. Participants are referred to geriatric~     clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that~     meet the current NHI medication reimbursement regulation and percentage of self-pay~     medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3~     different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert~     group meeting is to be held for FRAX® based osteoporosis medication reimbursement~     modifications to the NHI and the Department of Health.~      Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis~     screening and management model. 2) Base on the study results and expert consensus,~     investigators will provide policy suggestions of FRAX® based reimbursement modifications.~   "
86081|NCT01930643|"~     Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure~     would depend on ventilator support more than 14 days because of critical-illness weakness~     and their underlying diseases such as heart failure and chronic obstructive pulmonary~     disease.~      Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten~     their ventilator days.~      Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14~     days are eligible. EMS would be applied in experimental group 32 minutes/day on their~     bilateral thigh.~   "
86082|NCT01930630|"~     By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be~     separate from the adjacent organs.The space between esophagus and adjacent organs can be~     detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to~     be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The~     objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.~   "
86083|NCT01930617|"~     There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is~     still differing considerably between departments. Except for a recent randomized controlled~     trial (RCT) that found that postoperative subdural drainage was better than no drain, there~     is no higher level evidence. Another recent RCT did not replicate these findings, but the~     study was severely underpowered.~      Aim of this population based study is to compare clinical results (reoperation rates,~     complications, perioperative death, and survival) between neurosurgical departments treating~     CSDH with different treatment policies.~   "
86149|NCT01929889|"~     The study looks at whether treatment with iloperidone (Fanapt) is associated with~     improvements in social cognition in individuals who have been recently diagnosed with~     schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your~     feelings and the feelings of others) is closely related to functional outcomes, including~     communication, empathy, and emotional recognition.~   "
86182|NCT01929460|"~     Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst~     aspiration is equally effective to the usual regimen of 3 days of post-procedural~     antibiotics.~   "
86084|NCT01930604|"~     Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.~      It has been shown to have a deleterious effect on the quality of life measured using the~     Dermatology Life Quality Index (DLQI) which is one of the most widely used~     dermatology-specific quality of life instruments. This is comparable to the effect on~     quality of life in patients with severe psoriasis of the skin as well as to nodulocystic~     acne patients before treatment with oral isotretinoin.~      The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized~     controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect~     in palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a~     similar effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face,~     trunk, groin and feet) which is reported in case-reports and open studies there is still a~     great need for more controlled studies. This is why we will carry out this randomized,~     double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx~     A in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect~     and safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using~     the DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on~     quality of life using a generic instrument, the effect on anxiety and depressive symptoms,~     sweating, and patients´global assessment of therapy.~   "
86085|NCT01930591|"~     Ticagrelor is a first line therapy along with aspirin for patients undergoing primary PCI~     for STEMI. However, many patients are still treated with fibrinolytic therapy and the safety~     and efficacy of Ticagrelor has not been investigated in this patients population. The~     present study is proposed to study the safety and efficacy of Ticagrelor in patients~     undergoing PCI post fibrinolytic therapy for STEMI.~   "
86086|NCT01930578|"~     The objective of the study is to identify a pattern of bioimpedance in humans during acute~     food changes. As a part of this study the investigators will be administering sodium bromide~     in oder to measure extracellular water via the bromide dilution technique.~   "
86087|NCT01930565|"~     In an 8 week double blind randomized controlled split-face studies, we tried to compare the~     clinical efficacy, safety and histopathological changes between Lactobacillus fermented~     Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)~      Basically, this is a split face study - one side of face randomly assigned was applied with~     LFCO and the other side with TTO in same patients.~   "
86088|NCT01930552|"~     Primary Objective:~      To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV)~     aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil,~     and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.~      Secondary Objectives:~        -  To make a preliminary assessment of antitumor effects of the combination of FOLFIRI~          plus aflibercept in patients with measurable disease (RECIST 1.1).~        -  To evaluate the immunogenicity of IV aflibercept.~   "
86089|NCT01930539|"~     This is a randomized, controlled, unblinded pilot study for patients with vitamin D~     deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral~     vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to~     low bone density.~      The investigators will use FDA approved portable Ultraviolet B lamp for the intervention~     group, 70 patients will be recruited from October 2013 to end of January 2014 and study~     period is 12 weeks for each patient. Study completion will be end of April 2014.~      Study hypothesis: Ultraviolet B light with a portable UV device will increase Total 25~     hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.~   "
86090|NCT01930526|"~     Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for~     patients with chronic lung disease (COPD). Patients can improve their shortness of breath,~     walking distance and quality of life. However, many patients do not improve their overall~     fitness. They are too breathless to train at a high enough intensity. In a laboratory~     training study, patients with COPD improved their overall fitness by using single leg~     cycling. Despite this knowledge, single leg cycling has not been used clinically. The~     objective of this project is to use and assess single leg cycling in a clinical setting.~     Single leg cycling can be incorporated into a clinical service (replacing traditional two~     legged cycling) as the predominant aerobic training strategy, resulting in improvements in~     cardio-respiratory fitness (peak oxygen uptake).~   "
86091|NCT01930513|"~     Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea,~     OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early~     death from heart problems. They are also associated with lower levels of physical activity.~     Exercise strategies for weight loss, increasing physical activity and improving fitness are~     needed for obesity. In Obese individuals with OSA~        1. The investigators will compare corridor walking tests compared to laboratory exercise~          tests. The null hypothesis is that the peak oxygen uptake achieved and the~          cardiopulmonary response during both the six-minute walk test and Incremental Shuttle~          Walk Test would not be different from that observed during an Incremental Treadmill~          Test.~        2. The investigators will investigate whether cycling or walking uses more calories for~          the same intensity. We hypothesise that cycling (weight supported) will be endured for~          long.~        3. The investigators will compare commonly used exercise tests with levels of daily~          physical activity.~      The information from these three projects will help us set up the optimal exercise program~     for obese individuals.~   "
86092|NCT01930500|"~     The purpose of this study is to determine whether individual and/ group based~     neuropsychological rehabilitation focused on psychoeducation and teaching compensatory~     strategies has positive effects on the psychosocial wellbeing and perceived cognitive~     deficits in dyslexic young adults. The hypothesis is that both individual and group based~     neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and~     perceived cognitive deficits. Another purpose of this study is to evaluate weather~     individual and group based neuropsychological rehabilitation have different kind of effects~     on the wellbeing of the participants and weather either one of the rehabilitation formats is~     more effective than the other.~   "
86093|NCT01930487|"~     The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular~     blood flow in a randomized double-blind, crossover design.~      Based upon preliminary data, it is hypothesized that a dietary supplement containing a~     variety of ingredients with antioxidant properties will, compared to placebo, increase~     ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and~     maintain these effects over the course of the treatment period.~   "
86094|NCT01930474|"~     The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR~     and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in~     patients with non-small cell lung cancers. Therefore, the detection of altered genetic~     alterations is useful for predicting the treatment response for TKIs in non-small cell lung~     cancer patients. However, good quality tumor tissues are available only in <50% of patients~     with inoperable lung cancer for mutation analysis. In this study, the investigators will~     detect and quantify the genetic alterations in plasma. the investigators will investigate if~     the serial measurement of cancer-derived genetic alterations in plasma can provide a means~     for monitoring disease progression, as well as treatment response. In addition the~     investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma~     tumor DNA.~   "
86095|NCT01930461|"~     The purpose of this study is to investigate the efficacy and safety of different doses of~     sublingual tablets of house dust mite allergen extracts as compared to placebo in adults~     with house dust mite-associated allergic asthma.~   "
86096|NCT01930448|"~     Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that~     can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of~     cases. The mechanism and time course of these changes have not been well studied and are~     poorly understood. The primary aim of this study is to investigate the potential~     weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB~     subjects after similar weight loss.~   "
86097|NCT01930435|"~     This is a single arm study of the use of a personalized sterile humidification device for 12~     weeks for head and neck cancer patients undergoing radiation therapy to determine if the~     usage of this humidification system will result in a decrease in severity in head and neck~     related quality of life as measured by the MDASI HN subscale following radiation therapy as~     compared with historical experience. In addition, we are exploring correlative measures~     using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to~     mucositis and presumably related to quality of life as indicated by the patient.~   "
86098|NCT01930422|"~     The primary purpose of the protocol is to evaluate the effect of repeated application for 5~     consecutive days of a real tDCS compared to the application of a placebo tDCS (sham~     procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day~     5.~      The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on~     the left dorsolateral prefrontal cortex region will reduce the craving induced causing a~     decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the~     final visit between Day 15 and Day 20.~   "
86099|NCT01930409|"~     The purpose of this study is to determine whether is is feasible and acceptable to deliver a~     telephone based coaching intervention compared with education alone in community dwelling~     older adults (age 60 and older) after a fall related hip fracture.~   "
86100|NCT01930396|"~     The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness~     (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in~     hemodialysis patients.~   "
86101|NCT01930383|"~     To explore the clinical value of circulating tumor cells (CTCs) measurement for~     Hepatocellular carcinoma (HCC) patients.~   "
86102|NCT01930370|"~     Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard~     concentration has been suggested in facilitating the removal of phosphate and potassium. To~     test this hypothesis, the study will use a cross-over study design to evaluate phosphate and~     potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid~     (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the~     effects of the different dialysate bicarbonate concentrations on the removal of phosphate~     and potassium during hemodialysis~   "
86103|NCT01930357|"~     The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure~     regimen in healthy children and adolescents aged 2 to 17 years.~      Primary Objectives:~        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of~          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5~          international units (IU)/mL at D42, i.e. 14 days after the last vaccination.~        -  To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a~          lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.~      Secondary Objectives:~        -  To assess the clinical safety of each vaccine after each vaccine injection when~          administered in a pre-exposure schedule.~        -  To describe the immune response induced by each vaccine 14 days after the last~          vaccination, i.e. at D42, and 6 months after the first vaccination~        -  To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e.~          14 days after the last vaccination.~   "
86104|NCT01930344|"~     During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your~     abdomen. These allow long tools and a camera to pass to perform the surgery and allow the~     surgeon to see inside you. The cameras images are seen on a television screen, and this is~     viewed, like you watch television at home, in a two-dimensional (2D), form. This can make~     performing laparoscopic surgery very challenging, as you have to learn to appreciate depth~     while performing surgical tasks. Recent advances in viewing technology mean we now have the~     capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many~     centers have shown its superiority over 2D in lab-based experiments. However, this~     technology has never been compared against our normal gold standard 2D imaging in~     laparoscopic operations. This study aims to investigate whether there is a quantifiable~     benefit in using these new 3D imaging systems over 2D for laparoscopy, as we hypothesise~     that there is a marked benefit using 3D over 2D. Patients who have been placed on the~     waiting list for keyhole surgery to remove their gallbladder will be invited to take part in~     the study. If they agree, they will undergo the standard operation for removing their~     gallbladder as planned already. At the beginning of the operation they will be randomised~     (selected by chance) into one of two groups. One group will have their surgery performed to~     our current 'Gold standard' with the surgeon using a 2D camera and screen. The other group~     will have the exact same operation but with the surgeon using a 3D camera and screen. The~     intra-abdominal part of the operation will be recorded and viewed by an independent observer~     who is a surgeon, to assess for technical performance differences between operations~     performed in 2D and 3D, as well as time taken for the surgery. There are no extra risks to~     taking part and being randomised to the 3D group. The laparoscopic camera is the same size~     as a 2D camera and used in the same way. There are no real disadvantages, as patients will~     still undergo the operation they were booked for and will experience no change in their~     treatment. The aim is to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see~     if there is a marked difference with this new technology. Lab based studies imply that 3D~     imaging systems reduce surgical errors and operating time therefore could improve patient~     safety. This study may help improve laparoscopic surgery for future patients.~   "
86105|NCT01930331|"~     Phase IV, single center, 2 arms randomized controlled, open label study. Study will be~     conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics~     and efficacy of ARCO.~   "
86106|NCT01930318|"~     It is well established that the resistance to the effects of insulin on glucose metabolism~     develops with a lot of stress hormone release after surgical trauma. This condition is known~     as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic~     acidosis. Surgical IR not only affect glucose metabolism but also influence protein~     synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.~      Postoperative pain is a challenging task for patients and surgeons, and it is part of the~     stress response to trauma and surgery, while the fear of pain can exacerbate the stress~     response.~      The main aim of this study was to invest whether effective postoperative analgesia can~     reduce the stress response and insulin resistance.~   "
86107|NCT01930305|"~     To inversitage whether routine warming of blood is harmful to brain fuction of sugical~     patients receiving massive transfusion.~   "
86108|NCT01930292|"~     This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC),~     platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast~     cancer (TNBC).~      The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio~     1143 when administered to these patients in combination with full doses of paclitaxel and~     carboplatin.~      The primary objective of Part B is to consolidate the safety profile of the recommended dose~     of Debio 1143 when administered to these patients in combination with full doses of~     paclitaxel and carboplatin.~   "
86109|NCT01930279|"~     Sleep deprivation was found to affect many organs including the immune system and~     predisposing for various health consequences including diabetes hypertension infections and~     increase in neoplastic diseases.~      Subjects will be evaluated for immune parameters in peripheral blood test following a~     regular nigh sleep and compared with a test performed following a night shift in which they~     slept less than 3 hours.~      Each participant will serve as its own control.~   "
86110|NCT01930266|"~     Diet is the only source for calcium and the most important dietary source are dairy~     products. This presents a difficulty for children with IgE-mediated cow's milk allergy, who~     are unable to consume milk. We noted that IgE-CMA allergic young adults have a significant~     decrease in bone mineral density (BMD) compared to international reference values and also~     to geographically and age matched normal controls.~      Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and~     gender matched controls. This can be reversed by introducing dairy products following~     recovery from allergy, or by enriching the diet via other calcium sources.~   "
86111|NCT01930253|"~     Autoimmune cytopenias are a significant complication observed after hematopoietic cell~     transplant (HCT) and carries a substantial rate of morbidity and mortality. This entity is~     usually challenging to treat, resulting in prolonged hospitalization and predisposes~     patients to complications either directly due to the specific cytopenia or due to the immune~     suppression that is part of its therapeutic management. One of the mediators of refractory~     autoimmune cytopenias are antibodies produced by plasma cells, which are historically~     challenging to target. The purpose of this study is to use a proteasome inhibitor called~     Bortezomib for the treatment of refractory autoimmune cytopenias after HCT, and monitor the~     clinical response.~      This is a pilot study which will enroll 5 patients over 2 years, prospectively. Our~     hypothesis is that bortezomib will effectively target plasma cells and successfully treat~     refractory autoimmune cytopenias. This will be a relevant study as it will be the first step~     in establishing a novel therapeutic modality and potentially reducing length of~     hospitalization and degree of immune suppression for refractory autoimmune cytopenias.~   "
86112|NCT01930240|"~     The primary objective of the study is to assess the blood profile of the~     N-methylnicotinamide (MNA) following administration of TRIA-662 (N-methylnicotinamide~     Chloride). The secondary objectives of the study are to characterize the safety and~     tolerability of TRIA-662 and to assess any potential gender-related differences in the~     plasma profile of MNA. Changes in serum lipid parameters with particular reference to~     triglycerides, lipoprotein lipase, and blood pressure effects will also be noted.~   "
86113|NCT01930227|"~     The purpose of this study is to compare the effect of TEAS on hypotension after spinal~     anesthesia in patients undergoing cesarean section~   "
86114|NCT01930214|"~     The two objectives of the study are to assess the current standard of care treatment outcome~     in none/mild, moderate and severe calcified coronary lesions and to obtain financial data~     and procedure data to support reimbursement initiatives and health care economics analysis.~   "
86115|NCT01930201|"~     This retrospective chart review will demonstrate the feasibility of performing caudal~     epidural blockade in adolescents undergoing major orthopedic hip surgery and provide~     information regarding the feasibility of this technique's use on a regular basis.~   "
86116|NCT01930188|"~     This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is~     to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as~     add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.~   "
86117|NCT01930175|"~     To evaluate the safety, tolerability and efficacy of a single intravneous infusion of~     VAY736, compared to placebo, in pemphigus vulgaris patients.~   "
86118|NCT01930162|"~     This study is designed to evaluate the safety and tolerability of using HSC835 in patients~     undergoing single umbilical cord blood transplant.~   "
86119|NCT01930149|"~     Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk~     assessment. Cholesterol screening is recommended by the United States Preventive Services~     Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of~     preventive services, including in safety net settings, we will implement patient-directed~     reminders to health center patients who meet our eligibility criteria.~      The aim of this study is to determine if a mailed outreach message and facilitated ordering~     of screening lipid tests increases cholesterol screening test completion within 3 months~     among federally qualified community health center patients who are eligible for screening~     compared to usual care.~   "
86150|NCT01929876|"~     This open-label, 2-period, fixed sequence, drug interaction study will investigate the~     effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in~     healthy participants. Participants will receive multiple repeating doses of cobimetinib and~     itraconazole.~   "
86303|NCT01927731|"~     The goal of this clinical research study is to learn if taking Promacta (eltrombopag) will~     help your platelet count improve faster after your stem cell transplant. The safety of this~     drug will also be studied.~   "
86120|NCT01930136|"~     The study investigates whether a long-term 25% caloric restriction can prevent onset and/or~     progression of renal function deterioration, retinal involvement and cardiovascular~     complications in overweight/obese type 2 diabetic patients, trough the amelioration of~     concomitant metabolic abnormalities such as visceral obesity, insulin resistance,~     dyslipidemia, hypertension and inflammation.~      The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on~     subjects at risk of nephropathy. Secondary aims are to better understand the relationship~     between CR and the following aspects: renal disease and its associated metabolic~     abnormalities, retinopathy and cardiovascular complications, quality of life and treatment~     cost.~   "
86121|NCT01930123|"~     This study will advance several goals of the NIH Action Plan: 1) establish a~     multidisciplinary team to develop quantitative methodologies and imaging protocols for~     liver, 2) validate diagnostic criteria and methodologies for imaging in liver in both a~     cross-sectional and a longitudinal dietary intervention study of patients with NAFLD, 3)~     create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive~     MR markers to distinguish simple steatosis from NASH, and 5) define the dynamic changes in~     metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver~     injury.~   "
86122|NCT01930110|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective is to compare the efficacy of single-hormone closed-loop strategy and~     dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise~     and interval exercise.~      The investigator hypothesized that dual-hormone closed-loop strategy is superior to~     single-hormone closed-loop strategy in regulating glucose levels during exercise periods.~   "
86123|NCT01930097|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective of this project is to assess whether a dual-hormone closed-loop strategy would~     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)~     without a significant degradation in post-meal glucose control.~      Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus)~     is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus)~     during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis~     is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent~     bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better~     than conventional pump treatment in regulation of glucose levels in adults with T1D.~   "
86124|NCT01930084|"~     Purpose: To compare the effectiveness of a combination intervention strategy (CIS),~     consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and~     accelerated ART initiation for eligible participants delivered by facility personnel, and~     cellular appointment reminders delivered by study personnel, to the standard of care (SOC)~     on linkage to and retention in HIV care at 12 months among adults testing positive for HIV~     in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+~     non-cash financial incentives (FI) compared to CIS without FI on study outcomes.~   "
86125|NCT01929031|"~     The primary objective of this study is to compare the efficacy of a combination product~     containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as~     placebo for the treatment of post-surgical dental pain over an eight-hour period followed by~     a single dose of study medication (study stage 1). A secondary objective is to evaluate~     efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day~     post-surgical period (study stage 2).~   "
86126|NCT01929018|"~     The objective of this study is to examine the feasibility of using a collaborative-care,~     home-based rehabilitation program to improve functional outcomes for people recovering from~     lower limb amputation caused by vascular problems and/or diabetes complications. The primary~     hypothesis is that the rehabilitation program will result in greater improvements in~     performance-based and participant-reported measures of physical function, compared to~     standard of care after outpatient rehabilitation.~   "
86127|NCT01929005|"~     The investigators propose an innovative new model of care in which patients identified to be~     at high risk of hospitalization are offered care by a physician who will direct their care~     both in the hospital and in clinic but is able to do so because they see patients only at~     high risk of hospitalization. This allows these physicians to have a panel of patients that~     is small enough that they can provide them with continuing ambulatory care but sick enough~     for those physicians to have enough of their patients hospitalized at any time to justify~     having the physician spend several hours each morning seeing those patients in the hospital,~     making the model economically viable and clinically valuable for the patient. The~     investigators estimate that each of the 5 physicians the investigators propose to establish~     in this model will serve a panel of about 200 patients in steady state with an average of 10~     days of expected hospitalization and $75,000 each in Medicare spending per year, totaling~     $75 million annually. The investigators estimate that a 1% reduction in costs for these~     patients will be more than enough to cover the ongoing costs of the model the investigators~     propose; this is because the investigators' program reorganizes care rather than adding new~     forms of care.~   "
86128|NCT01928992|"~     The purpose of this pilot study is to provide credible performance estimate information in~     order to properly plan, design, and power a larger clinical study.~   "
86151|NCT01929863|"~     Metformin may have complex interactions in the gut and is generally first line therapy for~     type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant~     pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with~     metformin in subjects with T2DM. The purpose of this study is to investigate the safety and~     tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin.~     This will be a two-period crossover study; subjects will receive either GSK2330672 or~     placebo for 7 days in each period separated by a washout period of 13 to 15 days. All~     subjects will receive metformin throughout the study~   "
86129|NCT01928979|"~     Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical~     baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with~     nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal~     echocardiography (TEE).~      The study is a company-sponsored, global, multi-center, retrospective, non-interventional~     study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter~     and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will~     be identified through screening and review of medical records and included in the registry.~     Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The~     observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus~     until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If~     no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the~     observational period will end at 12 weeks after diagnosis at the latest. If more than one~     TEE was performed during treatment, the thrombus outcome will be collected from the last TEE~     performed within 12 weeks of treatment start.~   "
86130|NCT01928966|"~     The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds~     per day in the diet of women will alter dietary fatty acid intake or blood pressure.~   "
86131|NCT01928953|"~     This prospective hybrid longitudinal study was conducted in the United States (US), Canada,~     the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive~     understanding of the burden of opioid-induced constipation (OIC) in these countries, this~     study used a combination of web-based, longitudinal patient survey, retrospective data~     abstraction from medical records, and a prospective physician survey.~      The primary objective of this study was to estimate the rate of inadequate response to~     laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative~     use ≥ four times per reference period), and inadequate response (defined as fewer than three~     bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of~     Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too~     hard, straining to have a BM, feeling like you didn't finish a BM, and feeling like you~     had to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately)~     participants with OIC, by country and overall.~      The secondary study objectives are as follows:~        1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as~          use of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was~          defined as the use of at least two laxative agents, each used ≥ 4 times in the~          reference period;~        2. To describe the baseline demographic and clinical characteristics, including prior~          health status, comorbidities, constipation-related GI symptoms, and concomitant~          medications of patients with OIC;~        3. To describe drug utilization and self-management of OIC;~        4. To describe the pre-index and post-index healthcare resource utilization and estimate~          costs associated with the diagnosis, treatment, and general management of OIC~          (including laxative use) and events attributed to OIC, including both direct and~          indirect costs;~        5. To describe patient-reported impact of OIC on health-related quality of life,~          productivity, and pain management;~        6. To describe patient-reported treatment satisfaction with laxative use; and~        7. To describe physician-reported awareness of OIC and symptoms and understanding of~          patient-reported impact of OIC.~   "
86132|NCT01928940|"~     This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety,~     tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and~     GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I~     part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).~   "
86133|NCT01928927|"~     The main goal of this study is to see if a drug called telmisartan will decrease fibrosis~     (scarring) and inflammation (irritation) in people who are infected with HIV and doing well~     on their HIV medications. The study is also being done to see what effects telmisartan has~     on other signs of disease and inflammation in the body, and to see whether people who have~     HIV can take telmisartan safely and without side effects that make them want to stop the~     drug. Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance~     of heart attacks and strokes in people over the age of 55 years of age who are at high risk~     for these events.~   "
86134|NCT01928914|"~     This will be a randomized, single-blind, placebo controlled, parallel group study.~     Approximately 260 subjects will be enrolled in five groups. This study is designed to~     compare the effects of tafenoquine, administered as single dose as well as administered over~     three consecutive days, on the changes in QT duration to those observed in subjects dosed~     with either moxifloxacin or placebo.~   "
86135|NCT01928901|"~     Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to~     mucociliary clearance~   "
86136|NCT01930058|"~     This adaptive design study will evaluate the safety, pharmacokinetics, and effect on~     hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV~     infection. The study will consist of 4 parts evaluating participants infected with specific~     hepatitis C virus genotypes and up to 10 panels allowing for additional participants to~     enroll in each panel as specified in the study analysis. The hypothesis evaluated in the~     study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple~     dose administration of MK-8876 in participants with HCV infection.~   "
86137|NCT01930045|"~     This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX)~     given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics~     of raltegravir in human immunodeficiency virus (HIV)-infected participants. The study~     consisted of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study~     period separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by~     a Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1~     pharmacokinetics results before continuing to Part 2. The same participants participated in~     Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma~     concentration 12 hours after administration (C 12 hrs) would not differ significantly from~     raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after~     raltegravir.~   "
86138|NCT01930032|"~     The purpose of this study is to learn more about infection by Clostridium difficile (also~     known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease)~     that can live in the human gut. Some people have it without having any symptoms. In other~     people it can cause illness ranging from mild diarrhea to severe colitis (infection of the~     colon).~      C. difficile makes toxins that damage the cells that line the colon. The study doctors want~     to find out how these toxins cause damage to the cells in the colon.~   "
86176|NCT01929538|"~     Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with~     covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study~     is to define the optimal duration of stenting and the diameter of the cSEMS.~   "
86177|NCT01929525|"~     Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be~     investigated.~   "
86178|NCT01929512|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and~     co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state,~     respectively.~   "
86139|NCT01930019|"~     The effect of etomidate administration on the adrenal cortex in obese patients is still~     unclear. The objective of the study was to determine the influence of single dose of~     etomidate on cortisol secretion in morbidly obese. The participants were divided equally~     into etomidate and thiopental groups, depending on kind of intravenous anesthetic used for~     induction of anesthesia.~      Healthy patients in ASA class I and II awaiting elective abdominal laparoscopic surgery were~     included in the study. The participants were initially divided into two groups: the first~     group included patients with morbid obesity (BMI > 40), and the second group included~     patients with normal body weight (BMI < 25). All the patients inside the two groups were~     subsequently randomly and divided into etomidate and thiopental groups, according to the~     intravenous anesthetic used as the induction agent for general anesthesia. Finally, four~     groups of patients were analyzed: 1. obese, in which etomidate was used (OE group), 2.~     obese, in which thiopental was used (OT group), 3. patients with normal body mass, in which~     etomidate was used (NE group), and 4. patients with normal body mass, in which thiopental~     was used (NT group).~      The patients excluded from the study were those who: 1. did not agree to participate, 2.~     were treated with steroidal drugs, 3. had cortisol metabolism disorders or were treated with~     drugs with a potential impact on serum cortisol concentration, 4. had a preoperative risk~     assessment result of ASA class III, IV and V, 5. had an initial surgical laparoscopic~     technique converted to laparotomy, and 6. had surgical complications increasing the level of~     intraoperative stress.~   "
86140|NCT01930006|"~     In this study two MGCD265 oral formulations at dose level of 100 mg are administered to~     healthy male and female subjects under fasting conditions.~   "
86141|NCT01929993|"~     The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation~     Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in~     reducing the incomplete excision of disease.~   "
86142|NCT01929980|"~     The purpose of this trial is to study the safety and effectiveness of a drug called~     Bortezomib for the treatment of low blood cell counts after bone marrow transplant.~   "
86143|NCT01929967|"~     The investigators aim with this study is to investigate the mechanisms of immune deficiency~     in patients with heterotaxy syndrome through the use of novel biomarkers and a prospective~     questionnaire survey documenting the burden of infectious sequelae following enrollment. It~     is known that patients with under-active spleens (functional asplenia or hyposplenia)~     secondary to other (non-cardiac) conditions such as Sickle Cell Disease or Inflammatory~     Bowel Disease have a characteristic paucity of a B cell sub-class known as IgM memory B~     cell. This specific sub-class of B cell normally matures in the spleen and in those with an~     improperly functioning spleen a significant deficiency of this B cell class is seen on flow~     cytometry.~      Similarly, these same patients are noted to have increased amounts of 'junk' DNA / nuclear~     remnant in their red cells. This is seen on microscopy as a dark particle inside the red~     cell and is termed a Howell Jolly Body (normally less than 2% of red cells have these dark~     particles present). Part of a functioning spleen's normal task is to rid the blood of red~     cells that contain nuclear remnants and an under-active spleen gets behind on this task with~     a build-up of Howell Jolly Bodies in red cells present in the bloodstream. Flow cytometry~     can very quickly and accurately quantify Howell Jolly Bodies as well as IgM memory B cells~     from a small (~1.5cc) sample of blood. Normal IgM memory B cell ranges are known for healthy~     children from infancy onwards allowing interpretation of results against normative data~     ranges.~      The investigators aim to enroll 10 patients in this pilot study who have a diagnosis of~     heterotaxy syndrome (both asplenia and polysplenia) and to prospectively follow them after~     obtaining the initial biomarker sample. The family will be contacted once every two weeks~     for a period of 12 weeks and asked a series of simple questions taking approximately 5~     minutes on any recent infectious sequelae or symptoms. The questions will elucidate history~     of minor illness such as low-grade fever or cough to more significant events such as~     admission for in-patient antibiotic therapy of bacterial sepsis. Ultimately, with this pilot~     study, the investigators hope to obtain sufficient data to support funding applications for~     a larger, multi-center trial that will allow us to develop biomarker thresholds for future~     risk of sepsis.~   "
86144|NCT01929954|"~     This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the~     safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring~     extraction. The incidence and severity of adverse events will be summarized by group~     (GINTUIT and Bio-Gide).~   "
86145|NCT01929941|"~     This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1~     and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety,~     tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose~     of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of~     patients with solid tumors. Each patient group will participate in a phase of the study~     which is divided into two parts. The patient groups will be enrolled in a sequential manner~     starting with Patient Group 1.~      Patient Group 1~      Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986~     as monotherapy.~      Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and~     pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced~     malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of~     INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial~     pharmacologic effect. These doses will be used in Part 2 of the study.~      Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and~     preliminary clinical activity of INCB047986 using the doses identified in Part 1.~      Group 2~      Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or~     urothelial cancer.~      Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in~     combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic~     solid tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or~     second line), triple-negative breast cancer (second line) or urothelial cancer (second~     line).~      Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers,~     and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients~     enrolled in this phase will be limited to those with advanced or metastatic pancreatic~     cancer.~   "
86146|NCT01929928|"~     The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection~     system.~   "
86147|NCT01929915|"~     Long-term survival for patients with pancreatic carcinoma is low, even following resection,~     the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due~     to local recurrence, distant metastasis or both within one to two years after surgery2-4.~      Surgery has been suggested to accelerate the development of preexisting micro metastases and~     to promote the establishment of new metastases5. Release of catecholamine and~     proinflammatory products secondary to surgical stress is believed to promote cancer~     progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical~     stress. However, general anesthesia including numerous induction agents, volatile~     anesthetics and opioids, is associated with immunosuppression especially on the~     cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7.~     Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress~     while efficiently reducing general anesthetics consumption, seem to provide promising~     advantages to prevent perioperative cancer progression. Currently, most studies available in~     humans are retrospective and observational to evaluate regional anesthesia and prostate,~     colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study~     investigating major abdominal cancer surgery is available13. However, it is not specific to~     an individual cancer type and perioperative cell-mediated immunity is not evaluated.~      In this study, we aimed to identify whether epidural block beneficial to early surgical and~     late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative~     cell-mediated immunity functions including natural killer cells, helper and cytotoxic~     T-lymphocytes were also investigated.~   "
86148|NCT01929902|"~     The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.~   "
86152|NCT01929850|"~     Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines~     as greater than 100 pounds overweight and/or greater than 200 % of ideal body weight.~     Chronic underemployment, poor housing, child abuse, limited education, stress and anxiety~     are all associated with maternal morbid obesity. These latter conditions leave many patients~     in a state of economic, social and emotional poverty with need for life-long welfare~     support. For patients with true morbid obesity a standard surgical procedure is currently~     the procedure of choice especially among patients who fail standard medical intervention.~     The major procedures performed for morbid obesity include the Roux-en-Y gastric bypass,~     sleeve gastrectomy and laparoscopic band procedure. The sleeve gastrectomy is purely a~     restrictive procedure without malabsorptive components which involves one single staple line~     and can be performed laparoscopically in less than one hour. While these surgical procedures~     are recognized as standard procedures for patient who have failed medical treatment and~     are covered by most health plans, access to these procedures is limited for the medically~     underserved, rural, poor or underrepresented minorities since national, state and municipal~     health plans either provide minimal coverage or no coverage at all for surgery for morbid~     obesity. Reimbursement to providers offering these procedures is minimal and thus access to~     bariatric surgery is unlikely within a timely fashion.~   "
86153|NCT01929837|"~     Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus~     affects approximately 10-15 % of the population. The prevalence increases with age and it is~     estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of~     tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety,~     depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most~     therapies focus on alleviating the condition rather than treating the cause. Pathophysiology~     of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus~     patients and animal models suggest that tinnitus is associated with increased neuronal~     activity, increased synchronicity, and functional reorganization within the auditory cortex~     either uni- or bilaterally, but there are also functional alterations in brain areas outside~     the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique~     based on the principle of electromagnetic induction of an electric field in the brain by~     means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe~     method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz)~     have been shown to decrease cortical excitability both in experimental settings and humans,~     which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in~     whom hyperactivity of the auditory cortex has been observed in functional brain imaging~     studies~   "
86154|NCT01929824|"~     This study is aimed at understanding whether oral nitric oxide levels can be used as a~     non-invasive marker for the diagnosis and management of patient with eosinophilic~     esophagitis (EoE).~   "
86155|NCT01929811|"~     To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in~     neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin~     can increase the pCR rate combination with TEC regimen in neoadjuvant setting.~   "
86156|NCT01929798|"~     The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device~     using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1~     diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to~     compare closed-loop control with or without optimization of initialization parameters~     related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals~     and snacks.~   "
86157|NCT01929785|"~     This is a single center observational study. Duration of the study is 1 year. Participants~     will be followed in 2 groups. Group 1 will include all patients who have undergone a heart~     transplant, through the first year post transplant. Group 2 will include heart transplant~     recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously.~     It is anticipated each group will have 25 participants.~   "
86158|NCT01929772|"~     The aim of this study is to investigate if there is a correlation between lactate clearance~     and the course at patients with severe sepsis and septic shock at german intensive care~     units.~   "
86159|NCT01929759|"~     In this study we will use a multi-modal imaging approach of MRS and fMRI to comprehensively~     assess the biological changes in the brain associated with EFV-based regimen (EFV/FTC/TDF),~     specifically alterations in the brain circuitry, function and local neurochemistry, and~     their correlation with neuropsychological function. In a cohort of HIV-infected patients who~     are clinically stable on the commonly use regimen of EFV/emtricitabine (FTC)/truvada (TDF)~     or Atripla, we propose to replace the EFV component with a new integrase inhibitor,~     elvitegravir (EVG) boosted with cobicistat (COBI), given as the EVG/COBI/FTC/TDF Single~     Tablet Regimen (STR) to evaluate the EFV-related neural alterations. This is a~     multidisciplinary study which involves a team of infectious disease experts in the field of~     HIV, neuroradiologists with expertise in fMRI and MRS techniques to study various central~     nervous system and psychiatric disorders and a psychiatrist with experience and expertise in~     research on abnormalities of affective and motivational processing in the context of~     neuropsychiatric disorders. We will utilize the established clinical research platform in~     the Infectious Disease outpatient clinical practice at the Brigham and Women's Hospital,~     where there is currently have many ongoing HIV-related studies and a large panel of~     HIV-infected patients motivated to be involved in clinically relevant research. We propose~     to use advanced neuroimaging to measure biologically changes in the brain associated with~     long-term EFV use with the following specific aims:~        1. Determine changes in neurometabolites measured by MRS in the brain associated with~          long-term EFV use~        2. Assess for alterations in neural activity correlated with affective symptoms associated~          with EFV vs STR use using fMRI, and their associations with changes in neurometabolites~          assessed by MRS, and with changes in cognition assessed by Trail Making and Digit~          Substitution Tests.~        3. Determine changes in emotion, cognition and sleep quality after switching from EFV to~          STR, and how they correlate with subject treatment preference.~      This clinical study will extend our current understanding of EFV neurotoxicity by further~     defining the nature of these biological changes. Further elucidation of the neurobiological~     underpinnings of EFV-induced CNS toxicity will have clinical relevance in improving the~     quality of life and drug adherence of HIV-infected patients on ART, especially among older~     patients or those with baseline neuropsychiatric disorders, whom at baseline are more~     vulnerable to neurocognitive decline from long-term HIV infection.~   "
86160|NCT01929746|"~     The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of~     BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC)~     dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary~     objective of this study in this study population is to assess the safety and tolerability of~     BIIB019 administered as a single SC dose (75 mg or 150 mg).~   "
86215|NCT01928888|"~     The purpose of this study is to compare the efficacy and safety of a single oral~     administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg~     famotidine and a single oral administration of placebo (comparator without an active~     substance) in treating the symptoms of acute heartburn episodes. The study is designed to~     collect more efficacy data on Talcid® in patients using self-medication to relief the~     symptoms of acute heartburn.~   "
86161|NCT01929733|"~     Percutaneous closure is one of the methods used to treat, among other congenital heart~     disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years~     1998-2013 four hundred and fifty patients were catheterized in the department of pediatric~     cardiology and congenital heart diseases in Rambam health care campus, using various~     devices.~      In this retrospective research, the investigators analyze data from patients' medical files,~     to estimate and define the correlation between the patients' demographic and morphologic~     data to the type and size of chosen closure device.~      Aim of study:~      To create an algorithm that can be used to choose the proper device for percutaneous closure~     of the PDA, based on the characteristics of the patient and the PDA type.~   "
86162|NCT01929720|"~     This randomized clinical trial studies a cognitive-behavioral intervention to treat worry,~     uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as~     well as improve the well-being and quality of life of cancer survivors. This study also~     explores the neuro-immunologic correlates of anxiety and insomnia.~   "
86163|NCT01929707|"~     The main purpose of this study is to evaluate the safety and how well the body will handle a~     single dose of increasing strength of study drug LY3050258. Each participant will receive~     LY3050258 or placebo once, in each of two dosing periods. At least seven days will pass~     between doses. This study will last approximately 45 days for each participant. Screening is~     required within 28 days before the start of the study.~   "
86164|NCT01929694|"~     Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive~     function at rest; guaraná also contains caffeine, which can reduce perceived exertion and~     increase fat burning during exercise. The purpose of this study is to test whether consuming~     a guaraná and vitamin and mineral product before exercise influences affect (mood), physical~     exertion and fat burning during exercise and mental fatigue, cognitive performance and~     affect post-exercise.~   "
86165|NCT01929681|"~     Objectives:~      To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation~     (LFMS)in subjects with bipolar depression.~      Hypotheses:~      Investigators expect subjects who receive LFMS to show significant mood improvement one week~     after the start of a three day course of daily stimulation as compared to subjects who~     receive sham LFMS.~      Investigators expect subjects who receive LFMS to show immediate mood improvement over the~     first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.~      Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.~   "
86166|NCT01929668|"~     The purpose of this study is to compare preference of the patients, efficacy of preparation,~     and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid~     in patients with inactive ulcerative colitis.~   "
86167|NCT01929655|"~     To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese~     patients with CRPC and bone metastases after a multiple administration~   "
86168|NCT01929642|"~     The purpose of this study is to assess the feasibility and safety of administering~     rapalogues, sirolimus or everolimus, in participants with Tuberous Sclerosis Complex (TSC)~     and self-injury and to measure cognitive and behavioral changes, including reduction in~     autistic symptoms, self-injurious and aggressive behaviors, as well as improvements in~     cognition across multiple domains of cognitive function.~   "
86169|NCT01929629|"~     The purpose of this study is to assess the safety and tolerability of orally administered~     AZD0914 in healthy adult subjects.~   "
86170|NCT01929616|"~     The general objectives are to evaluate activity and the safety of regorafenib in a~     population of patients bearing advanced, refractory colorectal cancers and to explore the~     different downstream molecular pathways to identify tumor response and resistance~     mechanisms.~   "
86171|NCT01929603|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow~     patients continued access to olaparib after the PK phase and will provide additional safety~     data.~   "
86172|NCT01929590|"~     the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to~     single (4 L) or split-dose (2 L + 2 L) treatments are not different.~   "
86173|NCT01929577|"~     The purpose of this study is to determine the relative bioavailability of ASP015K under~     fasting conditions after single-dose administration between a test-tablet formulation and a~     reference-tablet formulation. This study will also evaluate the food effect on~     bioavailability of the test formulation, and evaluate the safety and tolerability after~     single-dose administration of the test- and reference-tablet formulations.~   "
86174|NCT01929564|"~     The participants of this study will be men & women ≥50 years who are deemed to have a 10-30%~     risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint~     British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise~     algorithm. This takes into account the participants age, sex, cholesterol values, blood~     pressure,family history and their ethnicity (SE Asian or not). The participants will be~     randomly assigned to one of two groups with the aid of a computer program called minim~     which uses their age, sex, BMI and smoking status to determine which broccoli each~     participant will consume on the intervention.~      Each participant will consume 4 x 100g of their assigned broccoli, each week for 12 weeks on~     top of their normal diet. They will be allowed to eat the broccoli whenever they want during~     the week, but will be asked to note down when they eat it. A steamer will be provided so~     participants can cook their broccoli for the required 4-5 minutes. Participants will be~     asked to keep two diet diaries during their time on the intervention, one before they start~     the intervention and one towards the end. Blood samples and urine will also be collected,~     pre and post intervention, for the analysis of biomarkers of CVD.~      This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich~     and the University of Reading(UoR), in Reading. Samples from the participants at both sites~     will be analysed at IFR, UoR and companies in the United States.~   "
86175|NCT01929551|"~     The purpose of this study is to compare the glycemic index of a beverage made of natural~     concentrated mango puree with natural concentrated pear juice with other five different~     products based on natural mango and pear ingredients in the form of fruit or juice against a~     control of 50-gram glucose load.~   "
86183|NCT01929447|"~     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most~     of whom are undiagnosed and untreated. The severity of the disorder is expressed by the~     Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of~     actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index~     incorporating in addition to the previous episodes also respiratory effort related arousal~     episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep~     studies, have led to the development of a variety of ambulatory sleep study systems.~      The primary objective of the study is to evaluate the newly developed WP200 with the unified~     probe (WP200U) compared to the currently used configuration of WP200 that uses an~     incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.~   "
86184|NCT01929434|"~     Cerebral palsy (CP) is described as a group of permanent disorders affecting motor~     development and posture, resulting in activity limitation attributed to nonprogressive~     disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased~     among the children with low birth-weight, jaundice, respiratory distress and intrauterine~     infection and so on. The incidence of cerebral palsy is increasing gradually with increased~     neonatal survival rate. Although there are many kinds of functional therapy programs~     especially the rehabilitation treatment for cerebral palsy, their effects are limited.~     Increasing cerebral palsy patients become a heavy burden to the family and society. Stem~     cell based therapy, a new prospective therapy for central nervous system disorders, has the~     potential to repair the damaged brain tissue in patients with cerebral palsy.~      In this study, 300 patients with cerebral palsy will be divided into three groups and the~     investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP~     patients of them randomly. We will also follow up the other 100 patients who only receive~     rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor~     rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of~     cell therapy and rehabilitation treatments for cerebral palsy patients.~      Multiple sources of assessment were used to ascertain and classify all cases of cerebral~     palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and~     reliable outcome measure, has made it possible to evaluate the severity of movement~     disability，change over time and the effects of clinical interventions. It also will be the~     primary outcome measure in follow-up analysis of this study.~   "
86185|NCT01929421|"~     To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination~     in metastatic colorectal cancer~   "
86186|NCT01929408|"~     The purpose of this study is to compare treatment methods and outcomes of patients diagnosed~     with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).~   "
86187|NCT01929395|"~     This is a 2 Phase study. In the first phase of the study, patients with palpable invasive~     breast cancer underwent pre-operative supine MRI and optical scanning in the surgical~     position. In the second phase of the study, patients with non-palpable invasive breast~     cancer or DCIS who desire breast conservation will be randomized to either a usual care~     group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and~     prone MRI) and undergoing breast cancer resection without the wire localization technique.~   "
86188|NCT01929382|"~     The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are~     the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches,~     and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy~     volunteers as well as in patients.~      This study is designed to determine whether a titration of dosing reduces the frequency and~     severity of the FLS. A reported study with another interferon (interferon beta),~     demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing~     was used. This study will compare the effects of the standard dose regimen with a titration~     regimen in healthy volunteers.~   "
86189|NCT01929369|"~     This pilot study will provide data to aid in the planning of a follow-up multi-center~     randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by~     formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm)~     was derived in consultation with the study PI and Co-PI who are experts in vascular surgery,~     and in particular, the field of hemodialysis access interventions. The results of this pilot~     study will provide the data that is necessary for generation of specific hypotheses that can~     then be formally tested in the follow-up RCT~   "
86190|NCT01929356|"~     Primary ciliary dyskinesia (PCD) is a rare disease, caused by impairment of the motile~     cilia. Patients present with chronic upper and lower respiratory tract infections. The~     therapy is mainly supportive and based on that of cystic fibrosis. Chest physiotherapy is~     one of the cornerstones of the therapy, however the influence of chest physiotherapy on lung~     function (short term and long term) is not clear. For interpretation of longitudinal lung~     function data it is important to examine the short time effect of chest physiotherapy. We~     hypothesize that a session of chest physiotherapy improves lung function and that thus lung~     function tests must be performed in a standardized way.~   "
86191|NCT01929343|"~     We propose that the systemic administration of lidocaine following the induction of~     cue-induced craving, relative to saline plus cue-induced craving or lidocaine without~     cue-induced craving, will block the reconsolidation of cue memories. This will lead to a~     reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and~     basal craving.~   "
86192|NCT01929330|"~     The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules~     compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this~     study are expected to support registration applications for androgenetic alopecia (AGA) in~     Japan and other international markets.~   "
86193|NCT01929317|"~     This study is a Phase III, multicentre, randomized, initial double-blind study with~     subsequent open label phases. The study will havea screening phase (4 weeks), a dose~     increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a~     long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase.~     Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance~     group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of~     increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in~     early and advanced PD patients who have not achieved an optimal therapeutic response with~     marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day)~     formulations.~   "
86194|NCT01929304|"~     Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief~     video education vignette to determine understanding and preferences among general emergency~     department patients of rescue access techniques. A challenge of emergency care is providing~     patient education surrounding procedures in a standardized and patient-oriented manner. This~     data would provide insight on a patient's understanding of the risks and benefits of rescue~     access, assess patient preference, and potentially influence what rescue technique is~     employed in the future. This information may also give us insight onto why DIVA patients~     might refuse randomization.~   "
86195|NCT01929291|"~     The purpose of this study is to collect safety information from pre-adolescents, adolescents~     and adults after Boostrix vaccination is administered according to the approved prescribing~     information in Korea.~   "
86196|NCT01929278|"~     Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that~     contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified~     vehicle. This was a single-center, evaluator-blinded, randomized, placebo~     (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24~     hour single applications of 3 sets of 3 study patches. The study expected to enroll~     approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel~     patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel).~      After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was~     removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and~     0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of~     patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75~     MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches~     (set C) was then removed, and those sites served as a non irradiated control. Inflammatory~     responses and other cutaneous effects were scored 1 hour after patch removal and during~     follow-up visits at 24, 48, and 72 hours after patch removal.~   "
86197|NCT01929265|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with~     advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).~   "
86198|NCT01929252|"~     The aim of this study was to investigate the analgesic efficacy of dexmedetomidine~     administration in wound infiltration for total abdominal hysterectomy.~   "
86199|NCT01929239|"~     This is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer.~     Subjects will receive escalating doses of T cells, with either low or moderate dose~     Interleukin 2. The T cells are collected by pheresis and then genetically modified, and~     given in a one time infusion.~   "
86200|NCT01929226|"~     To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous~     (IV) dose of ETI-204 in adult volunteers.~   "
86201|NCT01929213|"~     This study is designed to investigate the pharmacokinetic drug interaction and safety after~     oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers.~      Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence,~     Williams design~      Investigational Product: Udenafil, Bosentan~   "
86202|NCT01929200|"~     This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating~     such patients. The primary endpoint is to compare the recurrence-free survival after 1-year~     or 2-year treatment with icotinib.~   "
86203|NCT01929187|"~     Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection~     affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and~     has the potential to be a source of morbidity. Although oral antifungal agents achieve a~     better complete cure rate for onychomycosis, many patients are worried about the side~     effects and unwilling to take oral medications. Phytonail is a mixture of herbal active~     ingredients including tea tree oil, lavender oil and Australian blue cypress oil with~     BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails~     after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a~     broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several~     randomized controlled trials for the treatment of toenail onychomycosis.~      Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail~     lacquer in the treatment of toenail onychomycosis.~      Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with~     toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1~     ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before~     randomization, patients are to have onychomycosis in at least one great toenail with~     positive KOH examination and positive fungal culture. During the treatment phase, Phytonail~     will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all~     affected toenails. Physician's assessments and photographic analyses will be carried out at~     baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be~     performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and~     for KOH negative patients.~   "
86204|NCT01929174|"~     The purpose of this protocol is to measure the relaxation of the heart in subjects with~     single ventricles who have undergone the surgical Fontan procedure. We will do this by~     measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to~     blood levels that measure heart scarring. We will also measure relaxation before and after~     boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid~     in the heart. Measurements of heart relaxation will be obtained from the MRI,~     echocardiogram, and cardiac catheterization for each patient and compared to blood markers~     of heart scarring. We aim to compare all of these measurements to see if we can accurately~     identify heart scarring and, if present, how much it correlates with impaired heart~     relaxation.~   "
86216|NCT01928875|"~     The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and~     Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate~     anesthesia events, bradycardia and hypotension in comparison to standard clinical practice~     during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy~     and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood~     pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).~   "
86217|NCT01928862|"~     To study the efficacy and safety of Prepopik™ in children aged 9 to 16 years for overall~     colon cleansing in preparation of colonoscopy~   "
86205|NCT01929161|"~     The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion~     yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and~     thereby increases nonconscious motives that shape daily behavioral decisions to repeat it,~     which in turn foster positive emotions that further augment nonconscious motives in an~     upward spiral dynamic.~      The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e.,~     moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion~     yield of meditation, which varies by experimental condition, increases the nonconscious~     incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict~     positive emotions, sparking the relationships among OT manipulation, positive emotion yield,~     and nonconscious incentive salience of Wellness Behavior-related cues.~   "
86206|NCT01929148|"~     We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH)~     has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone~     (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian~     diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative~     surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative~     hospital stay, postoperative return to normal activity and complication rate) are related to~     PBS step in TLH.~      Although the good statistical reliability of our retrospective data, we want to~     prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by~     collecting also 3D ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index~     (VI), Flow Index (FI) and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic~     parameters may possibly be unified into a new diagnostic algorithm (already at an advanced~     stage of production in UMG Department) able to estimate the ovarian function both in term of~     reproductive ability that in term of distance from menopause.~   "
86207|NCT01929135|"~     Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the~     tissues surrounding the teeth. However, even if bacteria are required to initiate~     periodontal disease, the immune response is responsible for most of the destruction of the~     periodontal tissues. Statins may be used to control the immune response to periodontal~     pathogens, a factor that has not yet been managed clinically and even less massively.~      Recently it has been reported the pharmacological effectiveness of topically used statins.~     For periodontal disease, at least four well conducted clinical trials have been published~     using a topically statin formula for pocket irrigation in adult populations with chronic~     periodontal disease, observing surprising clinical results in all of them (with clinical and~     statistical significance) and no adverse reactions.~      The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin~     dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical~     examination will be made at the beginning and after one month of treatment.~   "
86208|NCT01929122|"~     The purpose of this study is to explore the effects of cooked navy bean powder or rice bran~     consumption on the stool microbiome and metabolome of colorectal cancer survivors and~     healthy adults.~   "
86209|NCT01929109|"~     The purpose of this study is to measure how much of the study drug, LY2409021, gets into the~     blood stream and how long it takes the body to get rid of it when given to participants with~     different levels of kidney function. There are five study groups. Each participant may only~     enroll in one group. Participants in groups 1 through 4 may be healthy or may have mild,~     moderate, or severe kidney disease. They will complete one study period lasting about 29~     days. Study group 5 will enroll participants with kidney disease who are on dialysis. They~     will complete two study periods which together last about 59 days. Screening is required~     within 21 days prior to the start of the study for all participants.~   "
86210|NCT01929096|"~     1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection~          versus Edaravone Injection for acute ischemic stroke patients;~        2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.~   "
86211|NCT01929083|"~     Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia~     (irregular heartbeat) known as torsades de pointes (TdP), which is associated with~     prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms~     for this increased risk in women are not well-understood. QTc interval duration has been~     shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the~     QTc interval response to drugs that may cause TdP is greater during the menses and ovulation~     phases of the menstrual cycle, during which serum progesterone concentrations are lowest,~     and lesser during the luteal phase, during which serum progesterone concentrations are~     highest. Additional evidence from our laboratory suggests that progesterone may be~     protective against TdP. Specific Aim 1: Establish the influence of oral progesterone~     administration as a preventive method by which to diminish the degree of drug-induced QT~     interval prolongation in women. Working hypothesis: Oral progesterone administration~     effectively attenuates enhanced drug-induced QT interval response in women. To test this~     hypothesis, progesterone or placebo will be administered in a crossover fashion to women~     during the menses phase of the menstrual cycle. QTc interval response to low-dose ibutilide,~     a drug known to lengthen the QT interval, will be assessed. The primary endpoint will be~     individually-corrected QT interval (QTcI) response to ibutilide, in the presence and absence~     of progesterone, which will be assessed by: 1) Effect on maximum change in QTcI, and 2) Area~     under the QTcI interval-time curves (AUEC). At the conclusion of this study, we will have~     established that oral progesterone administration is a safe and effective method of~     attenuating drug-induced QT interval prolongation.~   "
86212|NCT01929070|"~     The purpose of this study is to evaluate the pharmacokinetics of omega-3 between~     rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.~   "
86213|NCT01929057|"~     The purpose of this study is to determine the response of acne patients and healthy control~     patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants~     to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1~     to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects~     for further analysis in the lab to determine whether the inflammation in these pimples can~     be reduced using anti-P.acnes antibodies.~   "
86214|NCT01929044|"~     The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in~     comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.~   "
86218|NCT01928849|"~     The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the~     prevention of chronic neuropathic and post-amputation pain, as well as to further define the~     underlying inflammatory and epigenetic mechanisms that lead to the development of such~     chronic pain.~      HYPOTHESES AND QUESTIONS~      Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in~     surgical limb-injury patients will decrease the incidence of chronic nerve injury and~     post-amputation pain.~      Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial,~     investigators will determine if oral VPA added to regional anesthesia and standard~     perioperative management will reduce the incidence of nerve injury and post-amputation pain~     when compared with regional anesthesia alone.~      Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic~     mechanisms (differential DNA methylation) in genes involved in nociception.~      Goal 2: Investigators will analyze the DNA methylation patterns of patients with different~     types of neuropathic and post-amputation pain and determine if they are altered by VPA.~   "
86219|NCT01928836|"~     The purpose of this study is to verify clinical utility of a simple blood test comprising of~     four protein- based markers for risk stratification of patients presenting symptoms related~     to lung cancer.~   "
86220|NCT01928823|"~     Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective~     antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the~     central nervous system as an partial agonist on NMDA receptors. Because of glutamate~     mediated neuronal long-term potentiation in long-term memory DCS has an augmenting effect on~     emotional learning, as it occurs in exposure therapy of anxiety disorders. In this context~     we use DCS in addition to exposure therapy as a part of cognitive behavioral therapy (CBT)~     in patients suffering from agoraphobia with or without panic disorder. Thereby DCS is~     applicated oral as a capsule of 50mg, on three consecutive therapy sessions.~   "
86221|NCT01928810|"~     Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive~     behavioural therapy in patients with panic disorder and agoraphobia.~   "
86222|NCT01928797|"~     The purpose of the study is to learn more about how the heart works during cesarean delivery~     under spinal anesthesia (medicines given in the spine that numb parts of your body to block~     pain) in women. The investigators would like to find out if the information about the heart~     can help in treating blood pressure changes that occur during the cesarean delivery. The~     investigators would also like to find out if this information can help reduce the chances of~     nausea and vomiting during the cesarean delivery.~      The activity of the heart changes during spinal anesthesia and cesarean section. In the~     past, a sensor placed directly into the heart was the only way to see how the heart worked.~     Currently, there are monitors that can sense the heart's activity via sensors that are~     placed on the skin during cesarean delivery.~      In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON~     monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the~     activity of your heart.~      This study aims to:~        1. Determine if additional cardiac output measurements help anesthesiologists maintain~          appropriate hemodynamics as defined as within 20% of baseline BP and if it changed~          their choice of vasopressors (primary outcome).~        2. Determine if additional cardiac output measurements help to decrease the incidence of~          nausea and vomiting during cesarean delivery (secondary outcome).~   "
86223|NCT01928784|"~     The aim of this prospective study is to explore the pain-alleviating effect of low-energy~     extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.~   "
86224|NCT01928771|"~     The purpose of this study is to determine whether Benralizumab reduces the number of asthma~     exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.~   "
86225|NCT01928758|"~     The overall aim of this project is to evaluate the effect of progressive nicotine reduction~     in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with~     comorbid mood and/or anxiety disorders.~      Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain~     either a) nicotine content similar to their preferred usual brand of cigarettes, or b)~     nicotine content per cigarette that is progressively reduced from approximately 11 mg to 0.3~     mg over 6 months.~      It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine~     content in the Reduced Nicotine Content group without significant increases in tobacco smoke~     exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or~     protocol non-adherence over time in the Reduced Nicotine Content group as compared with the~     control group.~   "
86226|NCT01928745|"~     To diagnose acid base disturbances using blood gas analysis, multiple approaches are~     currently in use. These include the classic Henderson-Hasselbach bicarbonate approach and~     the physiochemical approach by Stewart1. All have shown to be mathematically compatible2.~      Diagnosing the metabolic component of acid base disturbances relies on the assessment of the~     so called ion gaps: the anion gap for the classic acid-base approach and the strong ion~     difference (SID) for the Stewart approach. This gap may unveil unidentified anions to~     provide a more accurate diagnosis. In particular they allow differentiating between relative~     hyperchloremia and other strong ions such as lactate, ketones, salicylates, citrate and~     ethylene glycol3.~      The accuracy of both gaps relies on the estimation of the weak acid dissociation: A-. This~     A- is dependent on the total concentration of weak acids (Atot) of which albumin is the most~     important and the effective dissociation constant for these (Ka), which determines the~     dissociated fraction of the Atot. This dissociation fraction needs to be accounted for in~     the ion gaps. This is reflected in the recommendation to correct the anion gap for albumin~     and incorporated in the SID which includes a factor for albumin by design3,4. However, the~     correction factor for albumin is currently based on data from animals and healthy~     volunteers4-9. In the critically ill albumin and protein content are very different compared~     to healthy volunteers, most notably in sepsis. Further, it is unknown if subunit composition~     of albumin is different in these patients. In addition, different protein species may be~     either up or downregulated in the critically ill1,8,9.Therefore from a pathophysiological~     point of view Atot and Ka and thus A- may differ in the critically ill. However it has not~     been previously investigated if and to what extent these matters affect Atot and Ka and~     therefore A- in this population.~      In addition, previous studies looking into this values showed a higher than expected value~     of unmeasured anions from the gap calculations. Despite rigorous experimental effort~     including high performance liquid chromatography, the origin of these unmeasured anions have~     not yet been elucidated17-20. However if the assumptions made in the Stewarts approach would~     not be valid, the existence of these unknown anions may have to be questioned.~      Thus it is of great interest to experimentally determine the exact contribution of the weak~     acids and their dissociation in sepsis. This could have major implications for these~     patients because different assumptions will ultimately lead to alterations in their~     calculated anion gap or SID. This may reduce unnecessary diagnostic test, alter final~     diagnosis and hence alter therapy.~      In this study the investigators aim to experimentally determine the Atot and Ka and thus~     their dissociated fraction A- in critically ill septic patients admitted to the intensive~     care unit by using in vitro CO2 tonometry, plasma dialysis and Marquardt regression~     analysis. In addition, as a control the investigators will do the same for patients admitted~     to the intensive care after routine cardiac surgery. Furthermore Atot and Ka values for both~     groups will be compared to values obtained from human volunteers in a previous study4.~      To achieve this, the investigators will plot CO2 versus pH titration curves from plasma~     samples of these patients. The investigators will then use Marquardt nonlinear regression~     analysis to quantify Atot and Ka and the SID by simultaneously solving for these~     parameters21. To make the quantification for Atot and Ka more robust, the investigators will~     also perform the same experiments after dialyzing the obtained plasma samples against a~     crystalloid solution of known composition in order to eliminate errors related to estimation~     of the SID. Finally, Atot and Ka values for both groups will be compared to values obtained~     from human volunteers in a previous study4. For application in the bicarbonate and base~     excess centred frameworks, Atot and Ka values will be related to albumin and protein content~     to update the correction factor for the anion gap in critically ill.~   "
86227|NCT01928732|"~     VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of~     psychotherapy, Prolonged Exposure and Cognitive Processing Therapy, for treating~     posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence~     that both treatments are effective in Veterans and non-Veterans, there is a lack of evidence~     about the effectiveness of these treatments compared with one another.~      The sample will include 900 male and female Veterans with PTSD due to any traumatic military~     event. Veterans who are eligible and agree to participate in the study will be randomly~     assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The~     standard dose of treatment is 12 weekly sessions but Veterans who improve more rapidly may~     finish in fewer sessions and Veterans who improve more slowly may have additional sessions.~     The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be~     measured at regular follow-up visits that will occur at the middle and at the end of~     treatment and then 3 and 6 months later. The investigators will measure other outcomes,~     including additional mental health problems, functioning, quality of life, and use of~     treatments for mental and physical problems. The investigators also will measure Veterans'~     treatment preference and examine whether Veterans who get the treatment they prefer do~     better than Veterans who get the less-preferred treatment.~      As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive~     information about whether one treatment is better than the other, overall and for different~     types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced~     military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients~     will have more information to help them make an informed decisions about which treatment to~     choose and VA will have stronger evidence to help make care Veteran-centered.~   "
86228|NCT01928719|"~     The overall goal of this study is to address the question of whether progressively lowering~     nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low~     socioeconomic status~   "
86229|NCT01928706|"~     Purpose: the aim of the present study was to analyze the impact of mandibular denture~     relining with soft or hard denture liners in the oral health related quality of life~     (OHRQoL) of edentulous patients.~      The null hypothesis was that there would be no difference in OHRQoL findings after~     mandibular denture relining between patient groups treated with hard or soft denture liners.~   "
86230|NCT01928693|"~     This Phase II study will evaluate the safety and efficacy of three fluoroquinolone~     ophthalmic agents to determine the optimal treatment in patients with infectious corneal~     ulcers.~   "
86233|NCT01928654|"~     Macular edema is the most important cause of visual impairment in diabetic patients.~     Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser~     treatment are two effective therapies for stabilising visual acuity. However, antiVEGF~     therapy is very expensive and potentially needs to to be repeated for all patients life.~     Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study),~     produces retinal burns with possible negative consequences such as alterations in the visual~     fields.~      With micropulse treatment modality laser energy is delivered in short pulses (micropulses)~     rather than as a continuous wave. In this way the amount of energy delivered to the retina~     and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the~     photothermal effects should avoid any retinal and RPE damage. At the same time, according to~     several published reports, the efficacy of treatment appears to be equivalent to~     conventional laser therapy.~      Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this~     treatment modality has been made available also with 577nm wavelength, which corresponds to~     the maximum absorption level for blood. Aim of this study is to assess the safety and~     efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser~     therapy.~   "
86234|NCT01928641|"~     Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of~     hyperacute cerebral infarction. The outcome of this treatment highly depends on the time~     from symptom onset to the administration of thrombolytic agent. Last known normal time is~     widely used as the standard to determine the symptom onset. These stroke symptoms are~     usually caused by a sudden decrease in cerebral blood flow related with an embolic or~     thrombotic event. However, in some cases various symptoms may occur one after another.~      Myocardial infarction is also caused by a sudden caseation of blood flow. The symptom of~     myocardial infarction usually contains chest pain, and it is easy to identify the exact time~     of onset. In contrast, cerebral infarction may cause various symptoms according to the~     infarcted area of the brain, and sometimes multiple symptoms are presented in rapid~     succession. Therefore, it may be much unclear and uncertain to determine the onset time of~     cerebral infarction. Despite the importance of onset time in therapeutic decision making,~     there was no study focusing on the certainty of onset time in cerebral infarction patients.~      In this study, we will investigate the subjective certainty of patient about the onset time~     in clear-onset cerebral ischemia. The discrepancy in diagnosing the onset time will be~     analyzed among the clinicians involved in the practice. Then, the factors associated with~     this uncertainty will be verified.~   "
86235|NCT01928628|"~     This study aims to compare and assess the efficacy and the safety of the combination agent~     of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with~     essential hypertension~   "
86236|NCT01928615|"~     This open-label, randomized crossover study evaluated the quality of life, efficacy, and~     safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper~     arm of participants with early HER2-positive breast cancer.~   "
86237|NCT01928602|"~     The few studies looking systematically into the neurophysiological and neuropsychological~     components of available therapies for chronic aphasia are highly heterogeneous in nature.~     Results from these studies have, unsurprisingly, indicated heterogeneous results, such as~     dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no~     consensus of how a successful therapy— that is, one that produces a measurable language gain~     in either production or comprehension —impacts the functional language networks of the brain~     in a specific type of aphasia population.~      A recent study has shown that inner speech (the imagination of speech) involves networks and~     areas dissociable from those implicated in speech production. Further, behavioural analysis~     has shown an interesting discrepancy between inner speech and overt speech (also called~     speech production) in a small chronic aphasia population: some participants elicited poor~     inner speech coupled with relatively intact overt speech, while others elicited relatively~     intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that~     inner speech and speech production are dissociable, though share similar networks.~      This discrepancy, and the notion that these speech components share a similar network,~     drives this study's hypothesis that improvement in speech production after rehabilitation~     might be facilitated by an intact inner speech network. Much as good athletes visualise~     their performance before the actual event in order to increase their chances of success, so~     too might intact inner speech facilitate speech production, helping to visualise the word in~     order to increase the success of produced speech.~      By studying a specific component of speech—inner speech—in a relatively homogeneous~     population of chronic expressive aphasics, the present study provides an explicit, critical~     means of understanding neurophysiological (as assessed by functional magnetic resonance~     imaging) and neuropsychological (as assessed by language batteries and personal~     questionnaires/interviews) changes occurring during speech therapy.~      As a secondary objective, this study will explore the effectiveness, feasibility and~     adherence to an at-home computerised aphasia software delivered via a portable tablet.~   "
86238|NCT01928589|"~     Women with ER negative breast cancer have a higher risk of the cancer returning in the~     breast after whole or partial breast radiation than women with ER positive breast cancer. In~     a small study at Johns Hopkins, women were treated with partial breast irradiation and~     chemotherapy given at the same time. This combined treatment was safe and women with ER~     negative breast cancer did just as well as women with ER positive cancer.~      We are now testing in a bigger study whether giving partial breast irradiation and~     chemotherapy at the same time (our new method) has the same side effects and outcomes as~     giving partial breast irradiation and chemotherapy at different times(older method). In this~     study women who had their breast cancer removed but need radiation to the breast will be~     randomized to partial breast irradiation at the same time as chemotherapy or partial breast~     radiation at a different time than chemotherapy. Randomization is like flipping a coin but~     in this study about 2 of every 3 women will get the new method.~   "
86239|NCT01928576|"~     Response Rate~   "
86240|NCT01928563|"~     This study is designed to investigate the pharmacokinetic drug interaction between Udenafil~     and Dapoxetine in healthy male subjects~      Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study~      Investigational Product : Udenafil, Dapoxetine~   "
86241|NCT01928550|"~     The purpose of this study is to evaluate the effectiveness of investigational Doppler~     Optical Coherence Tomography (OCT) and OCT angiography in the management of proliferative~     diabetic retinopathy (PDR - a leading cause of blindness in diabetic patients) before and~     after treatment. Angiography is the mapping of the blood vessels, and Doppler detects blood~     flow. PDR is due to poor oxygen circulation in smaller blood vessels in the back of the eye~     (retina), and is observed in 80% of people who have had diabetes for more than 10 years.~     This study will look at how blood flow to the eye is affected before and after treatment.~   "
86242|NCT01928537|"~     This study will examine the effect intravenously administered rigosertib has on the~     relationship between bone marrow blasts response and overall survival in myelodysplastic~     syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after~     treatment with azacitidine or decitabine.~   "
86244|NCT01928511|"~     Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue~     treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when~     therapy can be stopped. While HBeAg seroconversion is a more achievable endpoint, only~     20-25% of patients develop this after one year of oral antiviral therapy. HBsAg~     seroclearance is universally infrequent. Strategies to improve these endpoints such as~     combination oral antiviral therapy have not been generally successful and recently studies~     have examined the possibility of switching or adding peginterferon therapy. However these~     have not been tested adequately in the group of patients that have been on long term oral~     antiviral therapy. Consequently this study was conceived to evaluate whether switching or~     adding peginterferon compared to continuing oral antiviral therapy are more efficacious~     strategies. HBeAg positive and HBeAg negative patients (n=310)will be randomised to continue~     oral antiviral therapy, switch or add pegylated interferon for 48 weeks in a ratio of 1:2:2~     respectively. The study endpoints are HBsAg seroclearance, reduction of qHBsAg >1 log,~     qHBsAg<200 IU/ml, HBeAg loss and seroconversion, and HBV DNA suppression, all at week 72.~   "
86245|NCT01928498|"~     The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon~     catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of~     hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.~   "
86246|NCT01928485|"~     This randomized phase II trial studies how well green tea extract works in treating patients~     with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or~     slow the growth of certain cancers.~   "
86247|NCT01928472|"~     Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults~     between the ages of 18 years and 65 years.~   "
86248|NCT01928459|"~     To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose~     tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.~   "
86249|NCT01928446|"~     Observational evidence and findings from clinical trials conducted for other reasons suggest~     that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent,~     depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has~     not yet been adequately examined in a randomized clinical trial conducted specifically to~     test lithium's efficacy in preventing suicides. This clinical trial fills this gap.~      This study is feasible within the Department of Veterans Affairs (VA) because it is a large,~     integrated health system with existing programs for identifying patients at risk for suicide~     and delivering enhanced services. In VA, approximately 12,000 patients with depression or~     bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them~     repeat within one year. Experimental treatment in this study will supplement usual care for~     major depression or bipolar disorder, as well as VA's standard, enhanced management for~     patients at high risk.~      The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals.~     Participants will be patients with bipolar disorder or depression who have survived a recent~     episode of suicidal self-directed violence or were hospitalized specifically to prevent~     suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the~     patients nor their doctors will know whether a particular person has received lithium or~     placebo. The treatment will be administered and the patients will be followed for one year,~     after which patients will go back to usual care. Recruitment will occur over 3 years.~      The investigators are primarily interested in whether lithium leads to increases in the time~     to the first repeated episode of suicidal behavior, including suicide attempts, interrupted~     attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In~     addition, this study will allow us to explore whether lithium decreases the total number of~     suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive~     behaviors. If there is an effect of lithium, the investigators will be interested in whether~     or not it could be attributed to improved control of the underlying mental health condition,~     or, alternatively, whether it represents a direct effect of suicide-related behavior.~   "
86250|NCT01928433|"~     The primary objective of this study is to evaluate the microbiological and clinical outcome~     of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus~     ciprofloxacin for 10 days as a reference comparator.~   "
86251|NCT01928420|"~     The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment~     of Alzheimer's Disease.~   "
86252|NCT01928407|"~     A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the~     antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in~     combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in~     HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.~   "
86253|NCT01928394|"~     ADDENDUM- PLEASE NOTE: AS OF JANUARY 2017, THIS STUDY IS ONLY RECRUITING PATEINTS WITH~     BLADDER AND PANCREATIC CANCER. To investigate the safety and efficacy of Nivolumab as a~     single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast~     cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer~     (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of Nivolumab with~     Ipilimumab and Cobimetinib is also investigated in PC.~   "
86254|NCT01928381|"~     This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting~     training program in which a painful stimulus will be applied to the subject's hand, and the~     subjects will be asked to report how painful the stimulus is. Over the course of the pain~     training sessions, feedback will be provided to the subject about how accurately they are~     reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke~     pain. Those subjects who have adequate pain reporting ability will be asked to continue into~     Part 2 of the study in which 3 different blinded study drugs will be administered to each~     subject, in a crossover design to compare whether or not the study drugs improve pain~     associated with diabetic neuropathy.~   "
86255|NCT01928368|"~     The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy~     subjects and subjects with mild atopic asthma.~   "
86256|NCT01928355|"~     There is some evidence to suggest that obesity is a risk factor for the development of~     cognitive dysfunction, although this is not a universal finding. This discordance might be~     ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of~     metabolic risk factors. We examined whether the association of obesity with cognitive~     dysfunction is dependent on the individual's metabolic health.~      60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was~     defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol,~     triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as~     'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic~     abnormalities). Cognitive dysfunction will be assessed by moca and minimental score.~     Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was~     categorized as metabolically healthy. Relative to non-obese healthy participants, after~     adjustment for baseline covariates, the metabolically unhealthy obese participants had~     elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The~     association between obesity and risk of cognitive dysfunction appears to be partly dependent~     on metabolic health, although further work is required to confirm these findings.~      In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese~     patients suffer from higher incidences of cardiovascular complications such as~     atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein~     which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are~     three different types of Hp which differ in their antioxidant ability. Several clinical~     studies have shown that Hp 2-2 genotype is associated with higher incidence of~     cardiovascular diseases.~   "
86260|NCT01928303|"~     This study will develop and test an algorithm that will estimate drug dosage from drug~     levels measured in oral fluid (saliva). Traditionally, urine has been used as the principle~     medium to monitor drug compliance in patients receiving opioids for chronic pain as well as~     those being treated for substance abuse. Recently, the use of saliva as an alternative to~     urine drug testing has been gaining in popularity. Oral fluid has several advantages over~     urine as a medium for drug screening. In this study, oral fluid, urine and blood specimens~     will be collected from volunteer patient donors with chronic pain taking opioid medications.~     Samples from the anonymous donor will be analyzed for opiate class drugs, using New York~     State Department of Health approved and validated laboratory methods. Analytical results and~     other information collected will assist in evaluating the use of oral fluid as a specimen to~     detect opiate drug levels. The measurement of drug concentrations in blood and oral fluid~     simultaneously will allow for the determination of the amount of oral fluid that will be~     needed for successful drug testing. It is proposed that by measuring oral fluid drug levels~     an estimate of the amount of drug taken will be possible.~   "
86261|NCT01928290|"~     This phase II trial studies how well combination chemotherapy works in treating patients~     with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy,~     such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~   "
86262|NCT01928277|"~     The main objective of the study is to examine the extent of agreement between patient and~     health care provider assessments of work of breathing and the association of agreement with~     demographic- and disease-related factors.~   "
86263|NCT01928264|"~     We will conduct a randomized control trial to investigate whether and to what extent regular~     and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves~     physical fitness and (physio-)psychological functions (like subjective sleep, mental~     toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the~     ability to work, in claimants for a disability pension due to psychiatric disorders, whose~     ability to work had recently been assessed by means of a psychiatric expert opinion. The~     control group is designed very similar and implies predominantly sedentary leisure time~     group activities (e.g. playing board games, doing handicrafts). Measures will be performed~     at baseline, post-test, and at follow ups three and twelve months after post-test, some~     variables will additionally be assessed 4-weekly during the intervention. We expect that~     intervention group participants will report and show, respectively, more improved physical~     fitness, (physio-)psychological functioning and participations skills, as well as increased~     ability to work, compared to the control group.~   "
86264|NCT01928251|"~     According to the Census & Statistics Department (2011), there are still 659,300 daily~     smokers (11.1%) in Hong Kong. Smoking and passive smoking kill over 7,000 people per year.~     Smoking is addictive, and it is difficult for some motivated smokers to quit without~     assistance. On the other hand, many smokers may not be ready to quit or want to quit on~     their own, so it is difficult to reach them.~      Quit and Win programme is an opportunity to reach and encourage a large group of smokers to~     make quit attempt. Quit and Win Contest assumes that smokers can develop a higher motivation~     to quit and gain a wider social support in quitting. According to Cahill and Petera (2011),~     smokers can develop a high motivation to quit and gain a wider social support through~     participating in the Quit and Win Contest.~      The Hong Kong Council on Smoking and Health (COSH) organized three Quit to Win Contests~     and recruited over 3000 smokers from 2009-2012. These events enhanced the motivation and~     confidence to quit smoking. Lucky draw was also conducted to attract smokers to quit smoking~     and winners were validated by biochemical tests.~      Community-Based Participatory Research (CBPR) is an partnership approach that can enlighten~     and utilize the network within communities as community partners can obtain ample manpower~     and social resources. To effectively raise the awareness of the contest and recruit as many~     participants as we can from the community, working with NGOs in the 18 Hong Kong districts~     with a CBPR model may be one effective way of program implementation.~      Thus, we proposed to (1) test the effectiveness of combining competition and short-term~     monetary incentives to motivate smokers who participate in the Quit to Win Contest 2013 to~     quit smoking; (2) use a Community-Based Participatory Research (CBPR) model to build~     capacity and to engage community partners in taking on this important public health issue~     for sustainability in the community; and (3) conduct the process evaluation to assess the~     effectiveness of the recruitment activity and how it is linked with the overall program~     outcomes.~      Hypothesis:~      To examine the effectiveness of the interventions, three arms are (i) Group A: Informed~     early monetary incentive, which participants will be notified of the incentive through~     telephone follow-up at 1-week and 1-month follow-ups; (ii) Group B: Uninformed early~     monetary incentive, which participants will not be informed about the incentive until~     3-month telephone follow-up; (iii) Group C (control group): Uninformed late monetary~     incentive, which participants will not be informed about the incentive throughout 1-week,~     1-month and 3-month follow-ups.~      The primary outcomes are the self-reported 7-day point prevalence (pp) quit rate at 3 months~     of group A compared to group B and group C. The secondary outcomes include (i) self-reported~     7-day point prevalence (pp) quit rate at 6 months, (ii) biochemical validated quit rates,~     (iii) rate of smoking reduction by at least half of baseline amount, (iv) number of quit~     attempts at 3 and 6 months among the three groups and (v) the above cessation outcomes of~     all subjects, including or not including in the RCT.~   "
86265|NCT01928238|"~     The purpose of this study is to compare inspiratory effort, comfort, gas exchange and~     patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or~     pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in~     patient at risk of respiratory distress after extubation.~   "
86266|NCT01928225|"~     Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor~     response to treatment of cervical cancer precursors. This study will test whether giving the~     quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor~     will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a~     reduced occurrence or cervical cancer precursors in follow-up.~   "
86267|NCT01928212|"~     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can~     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber~     layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected~     in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's~     disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a~     common neurodegenerative disease characterized by motor dysfunctions, originally described~     by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells~     loss, which may correlate with RNFL thinning. Previous studies on this subject, however,~     reported contradicting results. Some investigations reported reductions of the RNFL~     thickness while others did not. In the present study, in order to determine whether RNFL~     thickness is reduced in PD patients, we performed a meta-analysis and systematically~     evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy~     control groups.~   "
86304|NCT01927718|"~     The goal of this clinical research study is to learn if adding low dose Thalidomide~     (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an~     autologous stem cell transplant. Researchers also want to learn if treatment with these~     study drugs will improve participants' quality of life.~   "
86268|NCT01928199|"~     The purpose of this study is to determine whether sitagliptin is effective in preventing the~     development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of~     previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids~     and calcineurin inhibitors are two commonly utilized anti-rejection medications that~     contribute to diabetes development through multiple mechanisms; including decreased insulin~     production by the pancreas. Sitagliptin is an oral medication that results in increased~     insulin secretion. We hypothesize that administration of sitagliptin to transplant~     recipients identified to be at risk for diabetes development will reduce the incidence and~     severity of NODAT.~   "
86269|NCT01928186|"~     This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography~     (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor~     (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast~     cancer. Comparing results of diagnostic procedures done before and during hormone therapy~     may help doctors predict a patient's response to treatment and help plan the best treatment.~   "
86270|NCT01928173|"~     The purpose of this study is to test the effectiveness of a 1-session abbreviated~     cognitive-behavior therapy for insomnia among college students. The investigators will~     examine the following hypotheses in the present study: 1) Viewing the treatment video will~     produce an increment in sleep knowledge relative to baseline and minimum treatment control;~     and 2) Viewing the treatment video will result in improved sleep relative to baseline and~     minimum treatment control.~      Students who self-identify as having insomnia will be recruited from the University of~     Alabama's Psychology subject pool. Students who enroll in the study will receive a link to~     the demographic and screening questionnaire. Individuals who have a history of other sleep~     disorders or who currently present with symptoms strongly suggestive of sleep disorders,~     such as obstructive sleep apnea or narcolepsy will be excluded. Individuals who are~     shift-workers and those with a history of severe mental illness will also be excluded.~      Participants who meet criteria for this study will then be directed to complete a measure of~     sleep knowledge. Once they have completed the measure of sleep knowledge, they will be~     directed to complete the Consensus Sleep Diary (CSD) for 14 days as soon as possible after~     awakening in the morning. During the second week of completing the CSD, participants will be~     directed to complete the Insomnia Severity Index and the Patient-Reported Outcomes~     Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms~     on the last day they complete a CSD.~      Participants will be randomized to a treatment group or a minimum treatment control group~     upon completion of these baseline measures. Those in the treatment group will be emailed the~     following components of the insomnia treatment: a link to the treatment video, an mp3 file~     with a relaxation recording, and a pdf file of a brochure reviewing the information~     presented in the treatment video. Participants will be asked to view the treatment video and~     begin practicing the relaxation technique presented in the mp3 file as soon as possible.~     Participants in the minimum treatment control group will receive a link to a sleep education~     video.~      Two weeks after participants have viewed the videos, they will be asked to complete~     post-treatment measures in the same sequence as they did at baseline. One month after the~     post-treatment measures have been completed, both groups will be asked to complete the same~     measures again for follow-up.~   "
86271|NCT01928160|"~     This randomized phase II trial studies how well pemetrexed disodium and carboplatin or~     cisplatin with or without erlotinib hydrochloride work in treating patients with epidermal~     growth factor receptor (EGFR) mutant positive stage IV non-small cell lung cancer and~     acquired resistance to first-line therapy with erlotinib hydrochloride or gefitinib. In~     patients that develop resistance to first-line therapy with EGFR tyrosine kinase inhibitors~     (TKIs) the drug is usually stopped and the patient is switched to chemotherapy. Drugs used~     in chemotherapy, such as pemetrexed disodium, carboplatin, and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether pemetrexed disodium and~     carboplatin or cisplatin is more effective with or without erlotinib hydrochloride in~     treating patients with EGFR mutant non-small cell lung cancer and acquired resistance to~     EGFR TKIs.~   "
86272|NCT01928147|"~     PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that~     is being developed as a potential treatment for hepatitis C virus infection. This study is~     being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy~     volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3~     days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the~     bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C~     virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.~   "
86273|NCT01928134|"~     This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to~     produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There~     are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of~     bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis~     improvement; (4) safety evaluation.~   "
86274|NCT01928121|"~     The purpose of this study is to assess the effectiveness of a newly developed~     interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a~     prospective, pragmatic clustered randomized controlled trial will be performed in general~     practices.~   "
86275|NCT01928108|"~     The purpose of this investigation is to prospectively evaluate the benefit of different~     methods of educating patients regarding their fluid intake through a readily available daily~     cellular phone application to improve overall urine output and reduce risk factors for stone~     recurrence.~   "
86276|NCT01928095|"~     The research objectives of this project are as follows:~        1. Obtain high-quality human atherosclerotic arterial samples from diseased donors.~        2. Perform biochemical analysis to determine the abundance, localization and activity of~          Dicer and double-stranded RNAs in these diseased tissues.~   "
86277|NCT01928082|"~     The purpose of this study is to assess if estrogen replacement normalizes urinary calcium~     excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for~     differences in response to estrogen replacement in women with familial hypercalciuria~     compared to nonfamilial hypercalciuria.~   "
86278|NCT01928069|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.~     Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
86279|NCT01928056|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.~     Dosing periods were separated by a washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
88626|NCT01897246|"~     The investigators are comparing post-operative patient-rated functional outcome between~     patients who undergo corrective osteotomy for extra-articular malunited distal radius~     fractures with and without computer assisted pre-operative planning and virtual osteotomy.~   "
86280|NCT01928043|"~     This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from~     symptoms of depression despite already taking a traditional mood-stabilizing medication.~     Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their~     mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be~     measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of~     treatment, and at the end of the study. Blood tests will allow us to determine whether~     changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we~     will use sophisticated technology to measure blood vessel functioning. We have three main~     predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2.~     Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked~     to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these~     improvements will be linked to improved inflammation and oxidative stress.~   "
86281|NCT01928030|"~     This phase 1-2 trial studies the side effects and the best dose of recombinant human~     hyaluronidase and to see how well it works in treating lymphedema in patients with cancer.~     Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in~     patients with lymphedema.~   "
86282|NCT01928017|"~     This is a prospective observational clinical study to characterise abnormalities of~     thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia.~     The investigators are also studying the relationship between Multiplate analysis and~     bleeding in these patients and the effect of platelet transfusions on thrombopoietin level~     and percent reticulated platelets.~      The investigators' hypothesis is that changes in TEG-parameters reflect the patients~     tendency to bleed.~   "
86283|NCT01928004|"~     The purpose of this study is to investigate denture satisfaction following the conversion of~     existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous~     patients who depend on help for activities of daily living (ADL) and evaluate secondary~     endpoints such as functional, structural, nutritional, cognitive and patient-centered~     outcome measures.~   "
86284|NCT01927991|"~     Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to~     provide psychotherapy. For several psychological and psychosomatic disorders, treatment~     efficacy was shown. Previously, iCBT has also been applied to patients suffering from~     tinnitus and results show significant and long-term stable improvements in tinnitus~     distress. However, the role of therapeutic support in iCBT has not been thoroughly~     investigated. Previous results suggest that iCBT without therapeutic support is less~     effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the~     randomized controlled trial is thus to investigate the role of therapeutic support in an~     iCBT for tinnitus sufferers.~   "
86285|NCT01927978|"~     This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging,~     therapy planning, and therapeutic response monitoring for esophageal cancer patients.~      Purpose:~        1. The incremental staging information by using 18F-FDG PET~        2. The impact of the PET results on the patients' subsequent therapy planning~        3. To compare treatment response using RECIST criteria and FDG PET results.~   "
86286|NCT01927965|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and the~     dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™~     recommended for future phase 2 protocol~   "
86287|NCT01927952|"~     The purpose of this research project is to compare three different methods for fixation of~     hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3)~     Stryker Smart-Toe implant.~   "
86288|NCT01927939|"~     This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic~     bone lesions and in predicting outcome for breast cancer patients after therapy.~      Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after~     treatment. The PET results will be compared with the results in Tc-99m MDP bone~     scintigraphy.~      Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic~     bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.~   "
86289|NCT01927926|"~     Developing functional foods that enhance satiety may be beneficial to individuals to help~     manage body weight.~      We have previously shown that consuming a mid-morning liquid preload with increasing~     proportion of energy derived from whey protein and addition of polydextrose reduced~     voluntary energy intake at a lunchtime meal compared to a liquid preload of the same energy~     content but lower in protein and containing no polydextrose.~      This study aims to investigate if these results can be replicated when the preload is in the~     form of a snack bar. We will also investigate whether the daily consumption of the snack bar~     has an effect on energy intake, subjective appetite and metabolic parameters compared to a~     control snack of the same energy but with a minimal protein content and without the addition~     of polydextrose.~      We hypothesize that the whey protein polydextrose snack will reduce voluntary energy intake~     at a subsequent test meal, suppress subjective appetite ratings compared with the control~     snack bar.~   "
86290|NCT01927913|"~     The purpose of this open-label study is to assess liver iron concentration using MRI imaging~     in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for~     the treatment of chronic transfusional iron overload.~   "
86291|NCT01927900|"~     The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study~     with healthy volunteers. A total of 100 male and female volunteers will be included. The~     volunteers will be randomized into one of 10 groups, each of 10 participants, consuming~     either active product in various mixes and doses (9 groups) or placebo product (1 group) for~     2 weeks. The 9 groups receiving active product will receive either one of two Human Milk~     Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of~     the study is establishing the effects of various compositions and doses of HMOs on the~     faecal flora and on gastrointestinal symptoms in health adults.~   "
86305|NCT01927705|"~     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with~     over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of~     phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj.~     by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately~     subacute and chronic Atopic Dermatitis.~   "
86306|NCT01927692|"~     The primary objective of the study is to longitudinally profile immunoglobulin levels and~     autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma~     exchange (TPE).~   "
86292|NCT01927887|"~     The purpose of this research study is to see if a specific kind of MRI can identify small~     and otherwise undetected abnormal lymph nodes in patients with thyroid cancer who are~     undergoing surgery. The MRI is called Ultra-Small Superparamagnetic Iron Oxide Magnetic~     Resonance Imaging (USPIO MRI), and uses an experimental contrast agent (ferumoxytol), to try~     to identify these lymph nodes. The MRI uses magnetic waves to take images (pictures) of the~     body and is commonly used in medical testing.~      Ferumoxytol is FDA approved as an iron replacement product for the treatment of iron~     deficiency anemia in adult patients with chronic kidney disease.~      In this research study, the investigators want to see if Ferumoxytol will help to identify~     very small metastases that are not usually seen on standard MRI scans. If the use of USPIO~     MRI with the experimental agent ferumoxytol identifies very small metastases in lymph nodes,~     your surgeon may decide to remove them. After the surgery, the nodes will be stored and then~     analyzed to assess the ability of USPIO MRI and ferumoxytol to detect cancer in very small~     metastases in the lymph nodes.~   "
86293|NCT01927874|"~     There will be compared the postoperative analgesic effect of infiltration or spinal block~     for hemorrhoidectomy~   "
86294|NCT01927861|"~     This trial is conducted in Asia. The aim of the trial is to investigate the long-term~     efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan~     syndrome.~   "
86295|NCT01927848|"~     Knee related mobility limitations are the leading cause of disability in the western world.~     It is a very expensive and debilitating condition when the cost of lost productivity and~     personal assistance is considered.~      In recent years there has been a growing interest in alternative medicine and many~     individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has~     been particular popular, and has been shown effective in relieiving pain - albeit the~     evidence is scarce.~      The purpose of this study is to evaluate the efficacy of specialized rosehip powder~     nutritional additives (Rosenoids®) on knee joint function during walking in subjects with~     knee-related walking limitations.~   "
86296|NCT01927835|"~     The purpose of this study is to evaluate the safety and immune response to two different HIV~     vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.~   "
86297|NCT01927822|"~     This study aims to analyze the factors influencing the abortion interval of second-trimester~     termination of pregnancy using misoprostol.~   "
86298|NCT01927809|"~     Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not~     completely understood. It is characterized by the absence of ganglia (nerve cells) in de~     distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic~     megacolon, ileus and enterocolitis. So far, several genes have been identified that play a~     role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study~     wants to identify new mutations and hopefully clarify more about the etiology of the~     disease.~   "
86299|NCT01927783|"~     Background:~      - Past studies suggest that the best way to improve heart health in the Black community is~     through community-based programs. Researchers will partner with DC community leaders. They~     will collect information about the health and health needs of people in mostly Black~     churches in DC. They will study things that affect heart health, like diabetes, blood~     pressure, cholesterol, and weight. They will also study how technology can keep track of~     activities and health. The information will show the health needs of this church-based~     community.~      Objectives:~      - To create an intervention for future programs to improve heart health in African-American~     churches in Washington, DC.~      Eligibility:~      - Adults ages 19 to 85 who attend one of the study churches.~      Design:~        -  Participants will visit their church for a 4-hour health exam. They will have their~          blood pressure and body measurements taken. They will have a drop of blood taken from~          their finger with a small needle. This blood will be tested for blood sugar and~          cholesterol. Participants will be given the results of these tests.~        -  Participants will answer questions about their health.~        -  All participants will be given an activity monitor to wear for 1 month. The activity~          monitor is worn around the wrist. Some participants will also receive an activity~          monitor that is worn around the waist. Participants will be given instructions on how~          to wear the activity monitors and follow the results on a website.~        -  At the end of 1 month, participants will return one device (they can keep the other).~          They may receive a gift card for completing the study.~   "
86300|NCT01927770|"~     Background:~      The purpose of this study is to investigate the process of consenting participants to whole~     exome/genome sequencing and its outcomes. It is unknown how best to consent people to this~     new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a~     companion to other NIH studies that involve genomic sequencing. Participants must be~     enrolled in a parent NIH study that is collaborating on this consent study to be eligible.~     Currently this involves only one NIH study.~      Objectives:~      - To learn the best way to help participants understand sequencing, so they can decide~     whether to join studies that use it.~      Eligibility:~        -  Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH)~          study that uses WES/WGS.~        -  Adults at least 18 years old whose children are enrolled in an NIH study that uses~          WES/WGS.~      Design:~        -  Participants will take part in the study either in person or over the phone.~        -  Participants will review two sequencing consent forms with a genetic counselor.~        -  Before and after meeting with the counselor, participants will answer several questions~          about sequencing. Each questionnaire will take about 15 minutes.~        -  Six weeks later, participants will answer questions about sequencing. This will take~          about 15 minutes.~   "
86301|NCT01927757|"~     To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid~     arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when~     used as their first biologic agent.~   "
86302|NCT01927744|"~     The goal of this clinical research study is to learn if adding erlotinib to a standard~     chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control~     SCCHN. The safety of this drug combination will also be studied.~      In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to~     be compared with a study drug to learn if the study drug has any real effect.~   "
86307|NCT01927679|"~     The main objective of the study is to assess the efficacy of an antioxidant in preventing~     pigmentation induced by visible light in subjects with a phototype IV or V.~      Patients will be exposed to a range of visible light to areas on the back to confirm study~     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be~     eligible to continue.~      Eligible patients will have study product applied to part of the back and placebo on another~     part of the back. The placebo area will be exposed to the same range of light based as at~     Day -7. The area where the antioxidant is applied will have a higher range of light exposure~     than the area without the study product.~      Seven days later, the areas will be examined to determine the lowest exposure inducing~     pigmentation on the sides with placebo and with antioxidant. The color will also be measured~     between two identical exposures with placebo and with antioxidant.~   "
86308|NCT01927666|"~     The variation in extent of isothiocyanate (ITC) excretion in urine from a capsule delivered~     dose of glucoraphanin will correlate with differences in (a) the gut microbiota, and (b) the~     genotype of key polymorphic genes (GSTM1, GSTT1, and other as yet undetermined candidate~     genes).~      Our study is a human dietary intervention in which participants will consume one capsule~     containing 100mg purified glucoraphanin from broccoli. The levels of glucoraphanin delivered~     by the capsule are similar to one to two portions of broccoli. As this is purified~     glucoraphanin there is no myrosinase enzyme present. All conversion of the glucoraphanin,~     contained within the capsule, to ITC will therefore occur by enzymes found in the gut~     microbiota.~      The ability of the glucoraphanin in the capsule to be metabolised to ITCs by the gut~     microflora is unknown and will be assessed by measuring ITCs excreted in the urine. The ITCs~     will be quantified in urine using validated analytical methods.~      It has been shown in human dietary intervention studies that the extent of conversion of~     glucosinolates varies greatly. In order to assess possible causative factors for variation~     in rate of glucoraphanin metabolism each participant will provide a faecal sample from which~     their faecal gut microbiota phylogeny will be analysed.~      For a small number of participants a second faecal sample will be requested (a maximum of 3~     participants). It is our aim to select one low, one medium and one high ITC excreter.~     Ideally the low and high excreters would be within the lowest and highest 5% excretion of~     ITC and the third participant would be as close to the mean ITC excretion as possible. The~     aim would be to culture the faecal microbiota over time with repeat dosing of glucoraphanin~     in order to select for microbiota that are able to metabolise glucoraphanin. It is known~     that the main hydrolysis product of glucoraphanin, sulforaphane, has a variety of benefits~     to human health, however there is no known clinical relevance to being a high, medium or low~     excreter of ITC.~      For each participant a blood sample will also be requested in order that we can assess~     whether genotype affects the rate of ITC excretion in urine. The GSTM1 genotype and other,~     as yet, unidentified candidate genes of each participant will be determined. Whether the~     genotype affects the rate of ITC excretion either alone or in combination with the~     phylogenetic profile will be assessed.~   "
86309|NCT01927653|"~     The hypothesis tested if the diffusion properties in the base line, such as mean diffusivity~     or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in~     Patients. The hypothesis further supports the correlation of the measured diffusion~     properties and the disease severity. We therefore proposed to investigate the potential~     value of diffusion properties as a possible tool to monitor the disease progression. The~     disease related changes in neural connectivity will be investigated.~        1. The diffusion MRI could provide an improved diagnosis of Alzheimer's Disease and Mild~          cognitive Impairment.~           Explanation:~           The deposition of the macromolecules such as beta amyloid in the brain and the~          associated neuron death of the patient could lead to observable changes in tissue~          microenvironment. The related changes would lead to alterations in either the amplitude~          or distribution of water diffusion. In turn it could be detected in diffusion tensor~          and kurtosis.~        2. aMCI is a preclinical state of AD and dMCI is from a different etiology, which can be~          differentially diagnosis by MRI. Diffusion Imaging could help to predict the clinical~          outcome Explanation~   "
86310|NCT01927640|"~     This study will use myocardial contrast echocardiography performed during a continuous~     intravenous infusion of Definity microbubbles (Perflutren lipid microbubbles) to determine~     if dexmedetomidine (an intravenous central sympatholytic drug) can reverse all the~     cardiovascular effects of low-dose intranasal cocaine—including vasoconstriction in the~     coronary microcirculation—both in cocaine-naïve and non-treatment seeking cocaine-addicted~     subjects.~   "
86311|NCT01927627|"~     The purpose of this study is to see how long it takes for prostate cancer to come back in~     patients who have had surgery to remove their prostate gland (radical prostatectomy), while~     being treated with enzalutamide (formerly known as MDV3100).~      Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it~     blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on~     testosterone for growth. In this study, patients will take enzalutamide after surgery to see~     if it keeps their cancer from coming back.~   "
86312|NCT01927614|"~     Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated~     thickening of the heart arteries of transplanted hearts. CAV limits the long term survival~     of heart transplant patients and is one of the common causes of death in the late post~     transplant period. Current methods of detecting CAV rest with invasive cardiac~     catheterization which carry repeated risks, as this test needs to be performed periodically~     through the life of a heart transplant patient. Traditional methods of coronary angiography~     identify CAV late in its course and is a crude method of evaluating coronary anatomy in~     heart transplant patients. Intravascular ultrasound is an additive tool that is able to~     detect early CAV before it becomes angiographically apparent, but still requires invasive~     cardiac catheterization to perform. However, it also limits assessment to the major~     epicardial arteries and does not give any information regarding the smaller branch vessels~     and cardiac microvasculature. Advances in cardiac CT and cardiac MRI hold potential to~     evaluate for CAV non-invasively. In addition, perfusion techniques may provide additional~     functional information regarding the status of the microvascular.~      In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI~     with and without perfusion protocols, in patients post-heart transplant and to describe and~     compare CT and MRI findings in patients with established CAV versus those with no CAV, as~     diagnosed by standard invasive methods.~   "
86335|NCT01927315|"~     Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the~     development of diabetic retinopathy are incompletely understood and include alterations in~     bone marrow derived vasculogenic cells called endothelial progenitor cells.~      Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and~     hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate~     has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the~     mechanisms that drive the development of this complication.~      Herein, the investigators hypothesize that fenofibrate treatment can increase circulating~     EPC levels in diabetic patients with retinopathy, compared to placebo.~   "
86336|NCT01927302|"~     The purpose of this study is to investigate the effects of treatment for specific language~     deficits in people with aphasia. In addition to language and cognitive measures, changes in~     brain function will also be gathered before and after the treatment is administered in order~     to track any changes resulting from receiving treatment.~   "
86313|NCT01927601|"~     The investigators seek to determine the feasibility of assessing neurologic injuries~     subsequent to transcathether aortic valve replacement (TAVR). Such a model has been applied~     previously by the principal investigator to assess and improve neurologic outcomes for other~     cardiac surgical procedures. The investigators shall assess patients during the following~     intervals: pre-procedure, within 72-96 hours post-procedure, and 3 months post-procedure.~     Case videos will be established to assist in identifying and associating emboli (using~     transcranial Doppler) and processes of clinical care during the TAVR procedure. Neurologic~     injury will be assessed in the following ways: stroke (neurologic exam, NIH Stroke Scale),~     silent infarcts (diffusion-weighted MRI, diffusion-tensor imaging), and neurobehavioral~     deficits (a battery of neuropsychological tests). Secondly, the investigators will~     investigate changes in the apnea-hypopnea index (AHI), a measure of sleep-disordered~     breathing, before vs after surgery between those subjects who develop post-operative acute~     brain infarction and those who do not. The investigators hypothesize that subjects who~     develop acute brain infarction will have an increase in AHI between baseline and post-op~     measurements compared with those subjects who do not develop acute brain infarction. A~     research coordinator will coordinate the testing.~   "
86314|NCT01927588|"~     CMV infection is common in transplant patients and can cause graft loss. CMV is a major~     factor in increasing morbidity, and post-transplant costs. The CMV infection is associated~     with many deleterious indirect effects including rejection, interstitial fibrosis and~     tubular atrophy, mortality. In addition to the potential for undesirable clinical outcomes~     associated with CMV, there is also a negative economic aspect. Patients who developed CMV~     events have been found to use significantly more inpatient and outpatient resources than~     patients without CMV disease. Universal prophylaxis is associated with high treatment cost~     and the potential for drug-related toxicity. It can be speculated that use of EVR may offer~     additional economic benefits in terms of decreased utilization associated with prevention of~     CMV disease, and reduce use of costly prophylaxis. Any efforts to reduce costs in renal~     transplants are very important and may have a great impact in total cost of a renal program.~     And the other hand, the clinical data suggest that EVR is associated with a decrease in CMV~     incidence compared to mycophenolic acid (MPA). CMV replication is dependent upon 1 ou 2 mTor~     pathways and in vitro studies support an association between mTor inhibitors and decreased~     CMV infection and disease. In cardiac transplantation, the use of EVR was associated with a~     lower incidence of CMV events. Some clinical trials data have also shown that use of EVR was~     associated with a lower incidence of CMV infection compared to MPA following renal~     transplantation. Brennan et al compared the incidence of CMV in three clinical trials using~     EVR versus MPA in De Novo renal transplants. They pooled for analysis the studies B201, B251~     and A2309, all double-blind, randomized, parallel-groups that compared the incidence of~     freedom form and incidence of CMV between EVR groups and MPA groups. The results of this~     pooled analysis of over 2000 patients de novo renal transplant demonstrated that EVR was~     associated with a decrease in and delay in the time of onset of CMV events compared to MPA.~     Our hypothesis is that basiliximab in combination with low dose tacrolimus, everolimus and~     prednisone may result in comparable efficacy (BCAR) observed in patients receiving~     tacrolimus/mycophenolate/prednisone but with a better safety profile (CMV infection) and~     cost-effectiveness.~   "
86315|NCT01927575|"~     To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can~     replace or compliment current imaging standards to assess patients with hip, wrist or tibia~     injuries.~   "
86316|NCT01927562|"~     The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal~     Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.~   "
86317|NCT01927549|"~     The study compares the therapies of instant multivessel balloon angioplasty plus stent~     implantation or the balloon angioplasty plus stent implantation of the infarct artery alone~     with any possible graduated later treatment of the other vessels in patients with acute~     myocardial infarction with cardioganic shock.~      The main study hypothesis is to explore if culprit vessel only PCI with potentially~     subsequent staged revascularization in comparison to immediate multivessel revascularization~     by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces~     the incidence of 30- day mortality and/or severe renal failure requiring renal replacement~     therapy.~   "
86318|NCT01927536|"~     The investigators are testing a Light-emiting Diode (LED) flashlight from First-Light™ USA~     called the Tomahawk MC Tactical Light to determine the range of colors people are able to~     see with these flashlights at night. The flashlight has been designed to reduce visibility~     of the user and uses a combination of green and red LED lamps to achieve this. In this study~     investigators wish to determine how well a subject can differentiate colors at night in a~     quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which~     requires the user to put shades of red, green, blue and yellow into progressive color order~     which is scored according to the manufactures specifications.~   "
86319|NCT01927523|"~     The purpose of this study is to learn more about the most cost-effective way to improve the~     long-term life outcomes of disadvantaged youth, by comparing best practice academic supports~     to best-practice non-academic supports, and learning more about whether investing in both~     simultaneously has synergistic (more than additive) effects.~   "
86320|NCT01927510|"~     Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their~     care. They develop muscle weaknesses even after only a few days of mechanical ventilation~     that may prolong their time in ICU and in hospital, delay functional recovery and delay~     their return home and to work. Weakness may be avoided with simple strategies of early~     exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may~     improve functional recovery in this patient group and gather pilot data to support a larger~     randomised trial across Australia and New Zealand.~   "
86321|NCT01927497|"~     Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal~     cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of~     positive margins and improves oncological outcome in distal rectal cancer. However, wider~     excisions increase wound healing problems and development of perineal hernia. This has~     resulted in a progressive increase of the use of musculocutaneous flaps and biological~     meshes associated with a substantial increase of costs, which is not supported by proper~     data.~      Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor~     reconstruction using a biological mesh after standardized eAPR with neo-adjuvant~     (chemo)radiotherapy.~      Study design: This is a multicenter study in which patients undergoing an eAPR are~     randomized between standard care using primary closure of the perineum and the experimental~     arm with assisted closure using a biological mesh.~      Study population: Patients with a clinical diagnosis of primary rectal cancer who are~     scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients~     will be randomized.~      Intervention: The intervention in the experimental arm consists of suturing a biological~     mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure~     similar to the control arm.~      Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated~     perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints~     are hospital stay, incidence of perineal hernia, quality of life, and costs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both primary perineal closure and biological mesh assisted closure are being~     performed in daily clinical practise. The potential benefit resulting from participation of~     the study in patients randomized for biological mesh assisted closure may be a higher chance~     of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand,~     the use of a biological mesh has been associated with increased postoperative pain and~     seroma formation.~   "
86322|NCT01927484|"~     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy~     currently exists. Synovitis is commonly demonstrated in knee OA imaging. Synovial~     inflammation due to the release of cytokines is an important cause of pain. Methotrexate~     (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly~     rheumatoid arthritis.~      The aim of the present study is to assess the efficacy of MTX in decreasing pain and~     inflammation in symptomatic knee OA.~      Methods: One hundred and forty-four patients with American College of Rheumatology (ACR)~     clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour~     average pain severity scale (0-10) using mean of daily ratings from week preceding~     randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be~     included in this randomized double-blind placebo-controlled trial. Patients meeting the~     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX~     (n=72) or placebo (n=72) together with their usual therapy provided the dosages were kept~     constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS,~     0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster~     Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.~     Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and~     tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.~   "
86323|NCT01927471|"~     The investigators would like to determine how aspects of metabolism and age influence~     ovarian function. The purpose of the study is to understand how nutrition and metabolism~     relate to follicle development in women with regular cycles, irregular cycles, or polycystic~     ovary syndrome (PCOS). We also plan to identify lifestyle factors associated with PCOS and~     understand how diet and activity levels impact features of PCOS.~   "
86324|NCT01927458|"~     The purpose of this study is to determine if transcranial direct current stimulation~     (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training~     is effective for improving gait in patients with subacute stroke and to evaluate the effect~     and predictive value of a single session of anodal tDCS.~   "
86325|NCT01927445|"~     The objective of this project is to increase the proportion of patients with AF that receive~     adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are~     permanently disabled. Yet there remains a large portion of patients who do not receive~     appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of~     quality improvement strategies in primary care could increase the proportion of patients~     with atrial fibrillation appropriately treated with stroke prevention therapy. The~     investigators' goal is to ensure the toolkit of interventions can be easily incorporated~     into day-to-day practice in primary care and can be readily and broadly disseminated if~     successful.~   "
86326|NCT01927432|"~     In women with regular menstrual cycles, antral follicles have been shown to grow in~     synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether~     these waves of follicle growth also occur in women with amenorrhea or if there is~     abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with~     metabolic disturbances, such as over- or under-nutrition, central obesity and insulin~     resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women~     are poorly understood. To understand potential mechanisms, the investigators plan to~     characterize follicle growth dynamics in women with or without regular menstrual cycles and~     identifying key metabolic differences in these women which may be important in normal~     follicle development and fertility.~   "
86327|NCT01927419|"~     The primary purpose of this study is to compare the objective response rate, as determined~     by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in~     patients with untreated, unresectable, or metastatic melanoma~   "
86328|NCT01927406|"~     The purpose of this study is to evaluate the potential secondary beneficial effect of~     prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study~     aims to determine if PA would change the course of the orbitopathy in TED patients by~     altering the progression of the common features of TED, including fatty hypertrophy,~     proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease~     and elevated intraocular pressure will be randomised to the PA treatment and the other eye~     will serve as a control eye and will be treated with Timolol.~   "
86329|NCT01927393|"~     This randomized clinical trial studies palliative care in improving quality of life and~     symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may~     help patients with advanced pancreatic or ovarian cancer live more comfortably.~   "
86330|NCT01927380|"~     The purpose of this study is to measure the variations of autonomic nervous system (ANS)~     modulation directed to the heart and vessels induced by pneumoperitoneum and steep~     trendelenburg position.~   "
86331|NCT01927367|"~     Research Question: Among community-based patients with AF, does providing an integrated~     Clinical Decision Support System (CDSS) to providers and patients improve process of care~     and clinical outcomes, and decrease the healthcare costs and resource utilization over 12~     months, as compared to usual care?~      Intervention: A web-based clinical decision support system, computerizing the Canadian AF~     clinical guidelines, to support primary care providers and patients in optimizing and~     standardizing AF care.~   "
86332|NCT01927354|"~     Investigation of the molecular mechanism and clinical significance of the interplay between~     Twist1 and other EMT regulators through microRNA-29 family.~   "
86333|NCT01927341|"~     The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to~     assess the anti-tumor activity of MEK162 in combination with panitumumab.~   "
86334|NCT01927328|"~     40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be~     randomized to a control or intervention group for management of this anemia. The control~     group treatment will consist of standard treatments as governed by the clinical team (eg~     oral iron, blood transfusions) whilst the intervention group will be treated with~     intravenous iron III isomaltoside (Monofer ®).~      It is hypothesized that intravenous iron supplementation is more efficacious than standard~     therapies.~   "
86337|NCT01927289|"~     This is a double-blind prospective randomized control trial. The primary hypothesis is that~     the preservation of motor function is superior in distal forearm blocks compared to~     supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's~     satisfaction, rate of block success, onset and duration of block.~   "
86338|NCT01927276|"~     Out of 300 million persons in the United States, about one-half of one percent, or 1.5~     million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and~     often is chronic and disabling for the remainder of the life course], which is shorter than~     for the general population by as much as 25 years. The costs of schizophrenia in the United~     States are estimated to be between $30 and $60 billion dollars annually. Treatment for~     schizophrenia is only marginally successful: in the Clinical Antipsychotic Trials of~     Intervention Effectiveness (CATIE), for example, the medication prescribed at the beginning~     of the trial was stopped or changed in nearly 75% by the completion of the trial 18 months~     later. The medications have limited effect on negative symptoms or cognitive impairments of~     schizophrenia, and many have severe and permanent side effects. The basic hypothesis~     underlying treatment for schizophrenia has not changed for more than half a century. New~     treatments are needed.~      Much accumulating evidence suggests that sensitivity to gluten may be related to symptoms or~     etiology in schizophrenia and that gluten free diets may lead to significant symptom~     resolution, but only in patients who are known to have antibodies to gluten.~      Gluten sensitivity may be more common than thought and stems from a different etiology and~     symptom presentation than Celiac Disease. The investigators analysis of the CATIE sample~     show that about 23% of persons with schizophrenia (compared to 3% of healthy controls) have~     Gluten Sensitivity (about 300,000 persons in the United States) through the identification~     of gliadin positive antibodies in their blood. The investigators hypothesize that people~     with this biomarker could have robust symptom improvements with the removal of the antigen~     from the diet (gluten). If only half of people with schizophrenia and these antibodies were~     to substantially benefit from removal of gluten from the diet, as in the case studies and~     with certain subjects in the clinical trials, this would provide a new transformative~     treatment option for an identifiable subpopulation of people with schizophrenia and would be~     of enormous benefit to patients, families and society. Another benefit to the public's~     health from this study will be enhanced knowledge of the etiology of schizophrenia,~     including possible linkages between neuropsychiatric disease and immune system activation,~     and identification of novel, immune-linked treatment targets.~      The results of this research could lead to screening for Anti-Gliadin Antibodies early in~     life or at the first episode of schizophrenia, as recommended by some already. Screening~     involves financial and emotional costs, and better evidence is needed before this~     recommendation can be justified. Moreover, a new treatment paradigm of removing gluten from~     the diet by means of gluten blocking medications (already in early study) could advance~     treatment significantly.~      This study will test the efficacy, in a pilot fashion, of 20 participants in a double blind~     five week randomized placebo controlled gluten free diet vs identical diet with gluten in~     gliadin-positive individuals with schizophrenia. Approximately equal numbers will receive~     the addition of gluten, or non-gluten starch, in identical form (given as flour in food).~     The investigators plan to develop mechanisms and procedures to locate, screen, and recruit~     subjects into the inpatient intervention study, retain them during the inpatient phase. Once~     admitted baseline assessments may take approximately a few days but will be mostly completed~     in the first week prior to the 5 week randomization, thus patients may stay longer than 5~     weeks. At the end of the double blind trial the investigators will prepare for discharge and~     then test the feasibility of successfully maintaining gluten free diets after the~     intervention phase is complete, for at least two months.~   "
86341|NCT01927237|"~     The purpose of this protocol is to perform serial physiological measurements and blood~     testing on mechanically ventilated patients comparing conditions of eucapnia and hypercapnia~     in the same patient. We will be testing two hypotheses: (1) while administering inspired~     carbon dioxide (CO2), eucapnia achieved by high respiratory rate (EHR) significantly~     decreases pulmonary artery pressures compared to hypercapnia with a lower respiratory rate~     (HLR), and (2) that EHR decreases myocardial strain compared to HLR.~   "
86342|NCT01927224|"~     This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30~     mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult~     subjects suffering from chronic Chagas' disease when administered after a high-fat /~     high-calorie test meal. This study is a necessary step for the development of an age~     appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic~     countries according to the recommendations provided by current international guidelines (EMA~     Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral~     Dosage Forms).~   "
86343|NCT01927211|"~     The study will investigate whether the placement of silver plated dressings beginning in the~     OR will improve wound healing in patients undergoing cesarean delivery compared to~     traditional Telfa pads. This study will also explore the presumed improvement in scar~     integrity when silver plated dressings are used compared to Telfa pads. The study will~     examine post-operative pain by review of anesthesia and analgesic use during hospitalization~     and scar-related pain scores at the post-operative visits.~      The study will compare the percentage of patients who develop a surgical site infection~     after application of silver plated dressings versus standard Telfa dressings. Investigators~     will also assess the cosmetic appearance of the cesarean section scar at the patient's one~     week and 6 wekk post-operative visits.~   "
86344|NCT01927198|"~     This study will assess the serum uric acid lowering effects and safety of 3 dose levels of~     RDEA3170 compared to placebo in subjects with gout.~   "
86345|NCT01927185|"~     Central venous catheterization is commonly applied in patients undergoing cardiac surgery.~     The subclavian vein has lower risk of infection and provides more patients comfort. However~     central venous catheterization may results in complications such as pneumothorax, hemothorax~     or arterial puncture. It has been suggested that ultrasound (US) guidance could improve the~     success rate, reduce the number of needle passes and decrease complications. Two different~     real-time 2-dimensional US techniques can be employed in the insertion of central venous~     catheters. The first technique involves real-time US-guided cannulation of subclavian vein~     using a long axis/in-plane approach. The second one involves real-time US-guided using a~     short axis/out-off-plane approach. However to date no studies have compared their efficacy~     and safety. The purpose of this study was to compare the US-guided long-axis versus~     short-axis approach for the SCV catheterization in adult critical care patients.~   "
86346|NCT01927172|"~     The purpose of this study is to determine if the AirSonea device provides an objective~     assessment of breath sounds for the presence of wheeze in both medical and home~     environments.~   "
86347|NCT01927159|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the~     prevention of pulmonary tuberculosis.~   "
86348|NCT01927146|"~     By literature review, there is a clear trend towards a potential role for human epidermal~     growth factor receptor 2 (HER2) as a negative prognostic factor in gastric cancer was shown,~     but only in half of the analyses used multivariate statistics. Besides, For the studies in~     the current review that have looked at the Lauren classification in relation to HER2, a~     higher level of overexpression or amplification was found in the intestinal phenotype~     compared to the diffuse or mixed types. As lauren classification was reported as an~     independent prognostic factor result in favored outcomes in gastric cancer (GC), there may~     probably be histologic bias exists when compare overall survival (OS) between HER2 statuses~     without controlling this confounding. Similarly, patients with different disease settings~     (early stage and advanced stage; resectable and metastatic) affect outcomes either.~      In this study, the investigators will retrospectively analyze HER2 status and lauren~     classification in 800 gastric patients who received gastrectomy in the Cancer Center of Sun~     Yat-Sen University between January 1996 and December 2006 with formalin-fixed and paraffin-~     embedded tumor tissue samples. To avoid potential influence by histologic classifications~     and disease settings, the investigators assess difference in OS between HER2 positive and~     HER2 negative groups in resectable Lauren classification of GCs, and further evaluate the~     prognostic value of HER2 status according to tumor-node-metastasis (TNM) stages.~   "
86349|NCT01927133|"~     Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and~     primary liver cancer) is 15,000 per year in France. These mortality increases, despite that~     advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10~     years before the onset of complications and cancer. The main goals of the FIBROFRANCE~     project which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the~     performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the~     dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis~     screening in French people.~      The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications~     among the 186 publications of our group since 1986 in the field of liver fibrosis. These~     publications included discovery and validation of non-invasive biomarkers (Poynard~     Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling~     fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002,~     Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin~     Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for~     the biochemical and clinical part in connection with national and international networks.~     Several panels have been identified and the most predictive FibroTest has been patented (US~     Patent Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker~     available worldwide (50 countries including USA as FibroSURE) with more than 1 million~     prescriptions between 2002-2013. FibroTest, has been validated first in hepatitis C and then~     in hepatitis B alcoholic liver disease and metabolic syndrome. Therefore it is now possible~     to screen advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and~     B, and metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients~     detected there are therapeutic options to cure the fibrosis or to reduce the progression to~     cirrhosis and cancer.~      FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL,~     EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France~     in chronic hepatitis C. Several factors of fibrosis progression can be present in the same~     subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic~     screenng strategy can be conducted without taking into account the Interdependence of the~     different risk factors. Three biomarkers of fibrosis-associated liver injuries have been~     developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp~     Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest~     for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts~     already used for diagnostic validation will be followed at long term for prognostic~     validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including~     dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol~     Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the~     specific risks of fibrosis progression imputable to steatosis and steatohepatitis.~   "
86350|NCT01927120|"~     IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with~     Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus~     host disease (GVHD).~   "
86351|NCT01927107|"~     The global obesity epidemic presents an unprecedented challenge to the public health~     worldwide. The factors associated with obesity are complex, and include health behaviors,~     such as eating habits and daily physical activity, and broader social, environmental and~     biological determinants that influence these health behaviors. The intestinal microbiota has~     several beneficial functions related to host health and accumulating evidence indicates that~     the gut microbiota plays a significant role in the development of obesity,~     obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift~     in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity~     of the gut microbiota and, probably, the way individuals harvest energy from nutrients.~     Differences in community composition, functional genes and metabolic activities of the gut~     microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis'~     contributes to the development of obesity and/or its complications.~      Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on~     obesity and metabolic syndrome in adults; such experience is limited in children and~     adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to~     standard therapy on anthropometric measurements, lipid profile and oxidative stress~     parameters in children.~   "
86374|NCT01926808|"~     The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with~     Vitamin D levels, measure affects of seizure medications on levels as well as pathologic~     fractures and bone density in severely cognitively impaired, non-mobile children and~     adolescents with CP.~   "
86352|NCT01927094|"~     -  Acute diarrhea continues to be a major cause of childhood morbidity and mortality in~          developed and developing countries.~        -  Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can~          be achieved with oral rehydratation solution (ORS).~        -  Even though ORS has reduced the mortality and morbidity very significantly, it has no~          effect on the duration of diarrhea, stool consistency and frequency and remains~          underused.~        -  ESPGHAN and ESPID published together an evidence based guideline and stated that in the~          management of acute gastroenteritis rehydration is the key treatment and that selected~          probiotics may reduce the duration and intensity of symptoms and can be used as an~          adjuvant to ORS.~        -  Current evidence also indicates that probiotic effects are strain-specific.~          Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However,~          more research is needed to guide the use of particular probiotic regimens and strains~          and as there is still no evidence of efficacy for many preparations.~   "
86353|NCT01927081|"~     The purpose of this research study is to evaluate whether self-management discussion groups~     are helpful for women with advanced breast cancer who are experiencing pain. The study is~     looking at the usefulness of two different types of discussion groups, one of which also~     includes gentle exercise.~   "
86354|NCT01927068|"~     Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of~     the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter in the treatment~     of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries Cohort~     2: To evaluate this patient population for treatment of in-stent restenotic lesions~   "
86355|NCT01927055|"~     Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week~     (maximum) treatment period in patients with symptomatic NOH.~   "
86356|NCT01927042|"~     Family therapy is considered an empirically supported treatment approach for adolescents and~     adults with eating disorders. One family based approach, Expert Carers Helping Others (ECHO)~     is based on evidence that suggests family environment, e.g., carer criticism, can influence~     an individual's eating disorder symptoms. ECHO aims to improve carer coping, reduce~     expressed emotion and manage eating disorder symptoms, and has been associated with reduced~     carer distress, caregiver burden, and an increase in general well being. The current pilot~     study seeks to evaluate a new condensed version of the ECHO intervention that is delivered~     entirely in a 2 ½ hour self-help DVD format (ECHOs). Sixty patients and their carers will be~     recruited from the Capital Health Eating Disorders Service and randomized into either a~     treatment as usual group (TAU) or a TAU+ECHOs group. Both carers and patients will be~     assessed along a variety of dimensions including psychiatric symptoms, family functioning,~     and carer and patient collaboration, at pre-intervention, four weeks later at~     post-intervention, and then three-months post-intervention. ANOVAs will be used to compare~     the primary outcomes between the two groups over time. This pilot study will be the first~     evaluation of ECHOs, which may ultimately boost the efficacy of current treatment for adults~     with eating disorders and reduce carer distress.~   "
86357|NCT01927029|"~     Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit~     of progesterone in this population. In contrast, singleton pregnancies are treated with this~     hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with~     placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each~     group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.~   "
86358|NCT01927016|"~     Background~        -  Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the~          eighth most common cancer worldwide~        -  The incidence is increasing rapidly~        -  The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes~          are related to diagnosis at advanced stages.~        -  Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but~          treatment of esophageal carcinoma remains challenging and need to be considered through~          a multimodal approach. However the modalities and the impact of this multimodal~          approach at a national level are unknown Primary objective: To identify predictors of~          recurrence after esophageal cancer surgery~      Secondary objectives :~        -  5-year recurrence free survival~        -  5-year overall survival~        -  Predictors of postoperative mortality and morbidity after surgery~        -  Impact of pCR on recurrence and survival~        -  Impact of neoadjuvant treatments on recurrence and survival~        -  Impact of patient preconditioning (such as nutritional support, esophageal prosthesis,~          mini-invasive approach…) on outcomes~      Methodology : European French-speaking retrospective multicentric study Inclusion criteria:~     All consecutive patients operated on, for a histologically proven carcinoma of the~     esophagus, the oesophago-gastric junction (Siewert type I and II), in surgical investigator~     centers between January 2000 and December 2010 Exclusion criteria: Siewert III type~     carcinoma of the oesophago-gastric junction , non surgical treatment of esophageal carcinoma~     Planned study period: The data will be collected over a 11-year period from January 2000 to~     December 2010. Follow up will be ascertained in May 2013.~   "
86359|NCT01927003|"~     Multiple digital injuries are often complex and severe, and the commonly used local and~     regional flaps may not be feasible. The authors reconstruct soft tissue defects of the~     fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.~   "
86360|NCT01926990|"~     This pilot clinical trial studies perfusion computed tomography (CT) in predicting response~     to treatment in patients with advanced kidney cancer. Comparing results of diagnostic~     procedures done before, during, and after targeted therapy may help doctors predict a~     patient's response to treatment and help plan the best treatment.~   "
86361|NCT01926977|"~     This study is designed to compare the post injection inflammation and pain seen after~     intravitreal injections of Ranibizumab vs Aflibercept.~   "
86375|NCT01926795|"~     Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern.~     Children have thickened periosteum compared with adults, which therefore may impart~     stability to the fracture without the need for additional immobilization. The goal of the~     study is to evaluate whether or not there is a difference in children treated with and~     without cast immobilization in regards to time to ambulation; perceived pain; difficulty in~     dressing & bathing; radiographic displacement or angulation; and time missed from work or~     daycare. Our null hypothesis is that there will be no difference in clinical or radiographic~     outcomes between the groups.~   "
86362|NCT01926964|"~     Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The~     test is currently not reimbursed by the Swiss health insurances.~      The proposed study will investigate to what extent adjuvant treatment recommendations in~     breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on~     conventional factors, and whether the recommendations would change, when RS results from the~     Oncotype DX® test were available.~      In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine~     therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor~     update from the 2011 consensus, is used to predefine the patients suitable for endocrine~     therapy or chemo-endocrine therapy. Once results of this study are available they may help~     to better integrate Oncotype DX® with other factors. Currently, it is unclear how the~     different factors should be integrated into one recommendation.~      This study will provide data on the usefulness of this test for the two patient groups which~     are suitable for hormone therapy only and for those who are considered for hormone plus~     chemotherapy.~   "
86363|NCT01926951|"~     This study will evaluate the effects of renal denervation using externally focused~     therapeutic ultrasound with external targeting and tracking on patients with refractory~     hypertension.~   "
86364|NCT01926938|"~     Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk~     for type 2 diabetes. The function of the endothelium has played a key role in the~     understanding of vascular complications in people with diabetes. Endothelial function and~     vascular reactivity are impaired not only in white adults with type 2 diabetes but also in~     those at risk for the disease by virtue of having impaired glucose tolerance or parental~     history of type 2 diabetes. Whether this finding is applicable to hispanics is not known.~     The investigators plan to assess the endothelial function and vascular reactivity in young~     Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging~     to a minority population.~   "
86365|NCT01926925|"~     Type 2 diabetes is now more frequent in children/adolescents, especially in those from~     minority populations, including Hispanic Americans (HA). Diabetes and the pre-diabetes state~     markedly increase the risk of cardiovascular disease. Endothelial dysfunction is seen in the~     earliest stages of atherogenesis, which ultimately leads to cardiovascular disease. The main~     aim of this study is to evaluate the endothelial function in HA children/adolescents who are~     at risk for developing type 2 diabetes (obese children/adolescents from the Hispanic~     population).~      The investigators' hypothesis is that endothelial dysfunction is present in this population~     and that it is associated with metabolic abnormalities linked to the insulin resistance~     syndrome. The investigators will study 2 groups of 15 individuals each, age 10-18 years.~     Group 1 will consist of obese (body mass index greater than 85th percentile for age and sex)~     Hispanic American children/adolescents and group 2 will consist of healthy, non-overweight~     (body mass index between the 25th and 50 th percentile for age and sex) Hispanic American~     children/adolescents.~      The study will be carried out at the Joslin Diabetes Center. During the first day,~     participants will have a medical history and full physical examination, a standard OGTT and~     measurement of blood cell count, plasma glucose, insulin, lipids, HbA1c, BUN, creatinine,~     electrolytes, estradiol, testosterone, free fatty acids, CRP, endothelial markers, urinary~     microalbumin and hCG, if appropriate. An OGTT will be performed in order to rule out IGT or~     Diabetes. Estimations of insulin secretion and insulin sensitivity will be assessed using~     the homeostasis model assessment (HOMA). In the second day, the body composition and the~     brachial artery vasodilatory response to hyperemia will be assessed. Those found with~     diabetes will be tested for GAD-65 and IA2.~      The investigators' hypothesis is that Hispanic American children/adolescents at risk for~     type 2 diabetes have impaired endothelial function and vascular reactivity that are~     associated with the degree of insulin resistance and its metabolic abnormalities.~   "
86366|NCT01926912|"~     The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate~     use and pattern of paliperidone palmitate usage in participants with schizophrenia in the~     hospital setting.~   "
86367|NCT01926899|"~     The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib~     in combination with calcineurin inhibitor and methotrexate as acute graft versus host~     disease (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem~     cell transplant (alloHSCT)~   "
86368|NCT01926886|"~     This single arm, multicenter study will evaluate the safety of assisted subcutaneous~     administration of Herceptin (trastuzumab) in patients with HER2-positive early breast~     cancer. Patients who have completed the first 6 cycles of intravenous Herceptin as part of~     the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of Herceptin in~     this study. For the first 3 cycles, Herceptin will be administered intravenously (6 mg/kg)~     at the hospital. The next 3 cycles, Herceptin (600 mg every 3 weeks) will be administered~     subcutaneously via a hand-held syringe by a trained HCP at the hospital, and for the last 6~     cycles Herceptin will be administered subcutaneously via a hand-held syringe by a trained~     HCP at the patient's home.~   "
86369|NCT01926873|"~     This multi-center screening study will conduct a cognition assessment to collect reference~     data for comparison to patients with depression in healthy volunteers. Data will be~     collected for 6 weeks.~   "
86370|NCT01926860|"~     The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will~     have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13)~     vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific~     serum antibodies and their opsonophagocytic activity. The results of volunteers receiving~     PCV13 and Epaxal will be compared to that in a control groups of adults receiving either~     hepatitis A or PCV13 vaccines only.~   "
86371|NCT01926847|"~     Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold~     causing acute lowering of blood flow through the digits. In this trial the safety and~     efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood~     flow will be measured during a cold exposure test in patients suffering from Raynaud's~     phenomenon. Measurements of two periods will be compared: in one period the patient will be~     given active drug and in the other period a placebo.~   "
86372|NCT01926834|"~     To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after~     acute cerebral infarction,test is made by random double-blind controlled.patients with acute~     cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin~     group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The~     review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function~     of promoting angiogenesis in multiple targets through this test.~   "
86373|NCT01926821|"~     The impact of sonifilan on the quality of life in patients with cervical cancer during~     radiation or chemoradiation therapy~        1. Primary endpoint : Quality of life~        2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan~   "
86376|NCT01926782|"~     The purpose of the study is to determine if the study drug (alirocumab)administered every 4~     weeks, given by injection under the skin is effective and safe compared with placebo in~     lowering cholesterol, if used alone or added to the participants' current~     cholesterol-lowering medication.~   "
86377|NCT01926769|"~     To determine the safety and efficacy of second-line treatment with Metformin and~     Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer~   "
86378|NCT01926756|"~     This is a prospective randomized controlled trial to look into the reduction of catheter~     associated urinary tract infections in the postoperative period. It will specifically look~     at short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and~     LEEP procedures and the need to perform intraoperative catheterization. If a patient~     urinates immediately before a short operation then there is no need to drain the bladder~     with a catheter during the procedure. The investigators hypothesize that eliminating~     catheterization during these short procedures may decrease postoperative urinary tract~     infections. The hope is that this study would provide evidence to support a change in~     practice.~   "
86379|NCT01926743|"~     Lymph node dissection in gastric cancer surgery is a very important factor not only for~     exact acquisition of stage but also proper treatment. Realistically, it is impossible to~     identify complete removal of lymph node in dissected nodal station by naked eye. The~     investigators can assess the route of lymphatic drainage and identify residual lymph nodes~     in dissected area. In the field of gastric cancer treatment, ICG and near infra-red~     fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel~     concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2~     lymph node dissection completely.~   "
86380|NCT01926730|"~     The proposed study is a randomized controlled trial of a limited restriction diet compared~     to a regular diet among patients with Crohn's disease (CD) in remission. At baseline,~     patients will complete a semi-quantitative food frequency questionnaire assessing usual~     dietary patterns over the preceding month. Disease activity will be assessed with the~     abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be~     assessed during follow-up using an internet-based questionnaire. Repeat assessment of~     adherence to the study diets will be assessed with food frequency questionnaires (FFQs)~     administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis~     will compare the time to relapse using Cox regression for patients in the two study arms. In~     the exploratory aim, we will compare outcomes among patients in the highest tertile for~     other food items and nutrients to those in the lowest tertile based on self-reported usual~     dietary patterns at baseline. Thus, the study population will be analyzed both as a~     randomized controlled trial and as a prospective cohort study.~   "
86381|NCT01926717|"~     This study is being done to learn more about how different surgery procedures bring back the~     quality of life.After removing the small intestine at least 20cm in patients with pancreatic~     cancer, Some patients develop problems because they are disorder their digestive system,~     such as cramping, heartburn,vomiting.~   "
86382|NCT01926704|"~     Human visual acuity and contrast sensitivity are highly dependent on various different~     parameters. Each should be optimized for perfect visual performance. However, in real life~     our eyes lack such parameters, which might lead to unsatisfying results even after spectacle~     correction or contact lenses.~      A promising approach would be to design intra ocular lenses (IOL), which are implanted into~     the eye for example in the course of cataract extraction and are able to compensate for the~     human eyes' aberrations.~      For example cutoff frequency, edge-sharpness or specific contrast for selected structure~     sizes would need to be considered. Since, an aberration free optical system is almost~     impossible and since the impact of each single parameter is not yet known, IOL design~     parameters would have to be chosen very carefully.~      Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but~     this does not guarantee perfect function after implantation, as our visual system has~     complex image precessing units form the retina to the brain.~      The present study picks one of these parameters and seeks to assess its impact on visual~     quality in-vivo. By subjectively grading different images with objective changes to image~     quality by variations of the modulation transfer function (MTF), the potential influence and~     thus on our subjective visual impression shall be assessed.~   "
86383|NCT01926691|"~     Background: Recent studies have demonstrated that even mild stroke survivors experience~     residual damage, which persists and in fact increases in subsequent years. About 45% of~     stroke victims remain with different levels of disability. While studies on cognitive~     impairment and dementia after stroke are receiving increasing clinical attention, the~     underlying pathophysiology is poorly understood. Identifying the mechanisms involved and~     recognizing early biomarkers for individual vulnerability, require a multi-modal approach,~     as the mechanisms involved in cerebrovascular disease and individual trajectories of~     post-stroke recovery may impact upon each other on various levels.~      Aims and Hypothesis: To date there is no single measure that can be used to identify~     patients who are prone to develop cognitive impairment and other disabilities from those~     with better recovery prospects.~      We hypothesize that data based on biochemical, neuroimaging, genetic and psychological~     measures can, in aggregate, serve as better predictors for subsequent disability, cognitive~     and neurological deterioration, and suggest possible interventions.~      Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study is an ongoing, prospective~     cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate~     stroke patients. It is designed to evaluate the association between predefined demographic,~     psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during~     the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events~     (including recurrent strokes), falls, affective changes, functional everyday difficulties~     and mortality.~      Discussion: This study is an attempt to comprehensively investigate the long term outcome of~     mild-moderate strokes. Its prospective design will provide quantitative data on stroke~     recurrence, the incidence of other vascular events and the evaluation of cognitive,~     affective and functional decline. Identifying the factors associated with post stroke~     cognitive and functional decline could potentially yield more effective therapeutic~     approaches.~      We believe that an extensive approach of analyzing the interaction between different risk~     factors would more accurately predict neurological deterioration.~   "
86406|NCT01926392|"~     Partial thickness burns are a common, painful injury requiring a great deal of resources in~     their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to~     remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy~     to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of~     pain control and resources required to deliver care.~   "
86493|NCT01925248|"~     The purpose of this study is to investigate whether intake of protein supplement just before~     meals lowers the blood sugar levels after the meals. It is believe that pre-meal~     administration of a high-protein supplement can effectively improve glycemic control in type~     2 diabetes (DM).~   "
86384|NCT01926678|"~     With approximately 12 million cancer survivors today in the United States alone, increased~     attention is being given to quality of life after cancer treatment. Cancer-related fatigue~     (CRF) is one of the most prevalent and debilitating symptoms experienced by people with~     cancer. It can persist for months or years after cancer therapy is completed and has a~     negative impact on all areas of function. Meaningful evidence-based treatment options for~     CRF are extremely limited and finding safe, inexpensive, and effective interventions for~     managing this distressing symptom are urgently needed. Basic research has shown that~     activation of the immune system can cause potent changes in behavior including reduced~     activity, fatigue, and decreased social behavior. Furthermore, research over the last decade~     has found a relationship between levels of CRF with increased inflammation. Thus, study of~     therapies that may decrease immune system activation in the setting of CRF represents a~     possible target for intervention. Massage therapy is one of the fastest growing alternative~     therapies and has a high rate of acceptance for symptom management among cancer patients.~     Massage has been shown in smaller studies with cancer patients to modulate the immune~     system. Moreover, massage has been demonstrated to significantly decrease markers of immune~     system activation in normal subjects. There are no published randomized controlled trials~     examining either the role of massage as an intervention primarily for CRF or investigating~     whether massage related decreases in immune system activation are responsible for~     improvement in CRF. This proposal investigates the effects of massage therapy on CRF among~     breast cancer survivors. The investigators' primary hypothesis is that Swedish Massage~     Therapy (SMT) will decrease CRF compared to a light touch condition and wait list control.~     The investigators' secondary hypothesis is that SMT will decrease CRF by reducing immune~     system activation. The investigators' main exploratory hypothesis is that a decrease in CRF~     will increase quality of life among cancer survivors.~   "
86385|NCT01926665|"~     The goal of this clinical research study is to find the highest tolerable dose of~     carfilzomib that can be given to patients with lymphoma after a stem cell transplant. The~     safety of this drug will also be studied.~      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~   "
86386|NCT01926652|"~     Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose~     of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with~     candesartan 32mg in healthy male volunteers.~   "
86387|NCT01926639|"~     Patients with non-curable disseminated follicular lymphoma receive local radiotherapy~     targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous~     dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to~     induce tumor immunity and clinical responses.~   "
86388|NCT01926626|"~     The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A~     inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This~     rationale is based on several findings from previous work: 1) cigarette smoke contains~     constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2)~     that severity of depression symptoms after smoking abstinence is correlated with the level~     of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was~     found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women~     show a greater association between smoking and depression than men and women smokers in our~     previous trials report smoking to alleviate symptoms of depression to a greater extent than~     men.~   "
86389|NCT01926613|"~     The purpose of this study is help people with serious mental illness and receiving~     vocational rehabilitation get and keep the job they want by improving their thinking skills,~     such as attention and memory, using computer exercises and other strategies. One half of the~     participants in the study will receive vocational rehabilitation and the exercises to~     improve thinking skills, and the other half will receive just vocational rehabilitation. All~     participants will receive an assessment of symptoms and thinking skills at the beginning of~     the study and 6, 12, and 24 months later. Work activity during the 24 months in the study~     will be collected. It is expected that those participants who receive the practice of their~     thinking skills will be more likely to get and keep the job they want compared with people~     who do not receive this treatment.~   "
86390|NCT01926600|"~     Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI)~     among different administration methods: per oral (PO), intravenous (IV), and sublingual~     (SL).~   "
86391|NCT01926587|"~     This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase~     II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been~     completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in~     combination with azacitidine, has measurable effects in patients with myelodysplastic~     syndrome (MDS). Safety of patients is an objective throughout all parts of the study.~   "
86392|NCT01926574|"~     Long-term sick-listing from work has considerable impact on social function, on the families~     of the sick-listed persons, the companies they work for, and society as a whole. Hence, the~     need for documented effective vocational rehabilitation programs is pressing. Vocational~     rehabilitation services described in the scientific literature have been specific to one~     single or a specific group of medical conditions (e.g.low back pain). In contrast, most~     people on sick leave have several health complaints, and many of the factors influencing~     sick leave are shared regardless of disorder (e.g. social surroundings, workplace~     environment), calling for rehabilitation programs that can be employed for both~     musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to~     investigate whether a group based rehabilitation program for musculoskeletal, mental or~     unspecific complaints can facilitate return-to-work (RTW), thereby testing two~     multicomponent return-to-work RTW rehabilitation programs.~   "
86393|NCT01926561|"~     Patients's demographics and perioperative factors affect the occurrence of hypotensive~     bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting~     position under interscalene block.~   "
86394|NCT01926548|"~     This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x~     200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.~   "
86420|NCT01926210|"~     This is a prospective, randomized clinical trial to compare the efficiency and safety of~     mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The~     randomization is achieved on the basis of a computer-generated randomization list in a 1:1~     ratio.~   "
86421|NCT01926197|"~     The goal of this study is to determine the safety and efficacy of a chemotherapy regimen~     known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body~     Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the~     disease and improve survival for patients with locally advanced pancreatic cancer.~   "
86639|NCT01923337|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with irinotecan hydrochloride in treating patients with advanced solid tumors or colorectal~     cancer. Irinotecan hydrochloride and alisertib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
86395|NCT01926535|"~     The amniotic membrane (AM) is an avascular structure derived from fetus, which is a good~     choice for regenerative medicine and effective treatment in eye surface pathologies such as~     bullous keratopathy (BK). This disease generates a chronic corneal edema evolving to the~     production of vesicles and bullae, chronic eye pain and visual acuity decrease.~      Definitive treatment for those patients is corneal transplant; however, donation is not~     always available and thus requires long waiting times. The currently available palliative~     treatment consists in the use of contact lenses to prevent the corneal epithelium from~     falling. However, this may be associated with corneal neovascularization, lens displacement~     or loss, infections, and discomfort for the patient.~      The objective of this work was to compare the use of amniotic membrane grafts versus contact~     lenses in patients suffering from BK awaiting a corneal transplant.~      A randomized clinical trial assay was performed with patients with a clinical diagnosis of~     BK. Twenty patients were randomized into 2 groups: amniotic membrane and therapeutic contact~     lenses. Eye pain intensity (Analog visual scale), visual acuity (Snellen questioner), bullae~     and corneal epithelial defects presence, as well as corneal neovascularization and~     complications (biomicroscopy) were compared during 6 months.~   "
86396|NCT01926522|"~     The investigators evaluated the effectiveness of the application of analysing treadmill,~     muscle strengthening and balance training compared to a control intervention in patients~     with diabetic neuropathy.~   "
86397|NCT01926509|"~     This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with~     pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of~     MK-8892 area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in~     participants with PAH, will be equal to or greater than the efficacious exposure in humans~     of 0.6 μM•hr.~   "
86398|NCT01926496|"~     The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or~     other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream.~     Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive~     a second treatment cycle with the same treatment if the first treatment does not clear all~     AKs. Subjects will be followed over a period of three year (36 months) after first treatment~   "
86399|NCT01926483|"~     The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial~     treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate~     the security of treatment, the QoL of patients and the influence to the PFS and OS.~   "
86400|NCT01926470|"~     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment~     of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious~     complication can be developed. Against this backdrop, if there is any difference of~     frequency of intravascular injection incidence during S1 TFESI between method in~     anteroposterior view and method in oblique view using Scotty dog, the result can be crucial~     factor in selecting the approach. In addition, appropriate volume of injection will be~     checked in each approach.~   "
86401|NCT01926457|"~     The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin~     A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of~     pregnancy, and patients will be randomized to first trimester or third trimester treatment;~     the first trimester group will receive intervention immediately upon diagnosis of~     prediabetes whereas the third trimester group will receive only routine prenatal care until~     28 weeks at which time they will receive intervention.~      Intervention is defined as:~        -  diabetes education~        -  blood glucose monitoring~        -  medications as needed~        -  growth ultrasounds~        -  antenatal testing~      The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include~     neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal~     gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's~     umbilical cord blood.~      The investigators hypothesize that women who undergo the above intervention in the first~     trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th~     percentile, and that the neonates will have lower fat mass, and weight-for-length at 12~     months. The investigators further hypothesize that a greater proportion of patients~     undergoing first trimester intervention will have appropriate maternal gestational weight~     gain as defined by the Institute of Medicine, and a greater proportion will return to~     prepregnancy weight within 12 months.~   "
86402|NCT01926444|"~     GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative~     to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a~     multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept~     Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching~     placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).~   "
86403|NCT01926431|"~     The primary aim of this study was to determine the effects of an acute bout of high~     intensity exercise on the brains response to viewing pictures of food using functional~     magnetic resonance imaging (fMRI).~   "
86404|NCT01926418|"~     The purpose of this study is to assess the utility of the Theory of Planned Behavior in~     predicting condom use among men who have sex with men. It also aims to assess the utility of~     two interventions, one known as implementation intentions, the other involves the practice~     of a planning task known as the tower of Hanoi, in increasing condom use in this~     population.~   "
86405|NCT01926405|"~     Hypersomnia is defined as a reduced ability to remain awake during the day. There are~     basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia.~     Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings~     which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.~      A biological marker of sleepiness, easily accessible and measurable, would be very useful~     for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary~     secretions appear as good physiological markers. Studies have shown for healthy subjects,~     that the expression and activity of salivary amylase are increased when subjects are~     deprived of sleep.~      The investigators propose to explore the usefulness of salivary biomarkers (including~     amylase) as a new non-invasive and simple technique for the assessment of excessive daytime~     sleepiness.~   "
86672|NCT01922908|"~     The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible~     and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose~     when given between 3-10 days after an ischemic stroke.~   "
86407|NCT01926379|"~     The purpose of the ENRICH study is to evaluate a combination intervention package (CIP)~     designed to improve implementation of Isoniazid Preventive Therapy (IPT) among people living~     with HIV (PLWH) in Ethiopia. The study is a two-arm cluster randomized trial, randomized at~     the HIV clinic level, which includes 10 HIV clinics in Dire Dawa and Harari, Ethiopia.~     Clinics are randomized to deliver the combination intervention package (CIP) or standard of~     care (SOC), with stratification by facility size (<80 or >80 patients enrolled in HIV care~     per year). The experimental intervention will be delivered to all patients in HIV clinics~     randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1, 2013~     and initiated IPT on or after date of study initiation, July 1, 2013. In HIV clinics~     assigned to SOC, usual care procedures for provision of IPT will be delivered.~      Study Aims and Hypotheses~      Aim 1. Characterize and compare the effectiveness of a combination intervention package with~     standard of care for IPT provision in Ethiopia.~      Hypothesis 1.1: IPT initiation for new patients enrolling in HIV care at CIP clinics will be~     higher than that for newly enrolled patients at SOC clinics.~      Hypothesis 1.2: Adherence to and completion of IPT for participants initiating IPT at CIP~     clinics will be higher than that for those initiating IPT at SOC clinics.~      Aim 1a. Assess acceptability of CIP among participants enrolled in HIV care and healthcare~     providers at CIP clinics. Acceptability will include: 1) perceived barriers and facilitators~     of uptake and delivery of the intervention package among healthcare providers, and 2)~     acceptability and utilization of intervention components as well as the overall intervention~     package among IPT initiators and non-initiators.~      Aim 2. Assess the impact of CIP compared with SOC on HIV-related outcomes.~      Hypothesis 2: HIV-related outcomes for participants receiving IPT at CIP clinics will be~     superior to outcomes in participants receiving care at SOC clinics. HIV-related outcomes to~     be assessed include retention in care and, among those participants receiving antiretroviral~     therapy (ART), adherence to ART and CD4+ count.~      Aim 3. Assess the safety and tolerability of IPT among HIV-infected individuals under~     routine program conditions in Ethiopia.~      Aim 4. Identify patient and program characteristics associated with IPT adherence and~     completion at SOC sites.~      Hypothesis 4.1: IPT adherence and completion will be associated with modifiable patient~     characteristics, including ART status; knowledge and attitudes about IPT; and social~     support.~      Hypothesis 4.2: IPT adherence and completion will be associated with modifiable program~     characteristics, including provider/patient ratio, patient tracking, and patient support~     groups.~   "
86408|NCT01926366|"~     This is a randomized, double-blind, placebo-controlled study of single and multiple~     ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day~     screening period, an in-house period during which AZD6423 or placebo will be administered~     IV, and a 4- to 10-day follow-up period after discharge.~   "
86409|NCT01926353|"~     Endoscopic correction of VUR has gained its popularity due to its less invasiveness,~     associated low morbidity and short hospital stay. Although short term follow-up had~     justified their efficacy; however, long term recurrence and complications following~     endoscopic correction were also being reported in the literatures (6). Currently, there are~     insufficient evidences on the efficacy and safety of biocompatible tissue augmenting~     materials used for endoscopic correction of VUR; particularly on the new tissue bulking~     agents. (6) Polyacrylate polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba,~     Argentina) is the newest tissue augmenting biocompatible Acrylics used for endoscopic~     correction of VUR.~   "
86410|NCT01926340|"~     The study aims to examine the relationship between early maintenance therapy decision in~     first episode psychosis and the subsequent long-term clinical outcome at 8-year by comparing~     a group of patients who were randomized to discontinue or continue mediation in the early~     stage of their psychotic disorders.~   "
86411|NCT01926327|"~     Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the~     knee has significantly elevated in the elderly population and youth due to age and sport~     activities respectively. Our aims to treat the knee osteoarthritis are including; reduce~     knee pain and improve its function; return patients to normal daily activities and reduce~     health care costs.~      The current treatments which are already being used for osteoarthritis of the knee patients~     include:~        1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and~          non-steroidal anti-inflammatory drugs.~        2. Intra-articular injections of corticosteroids and hyaluronic acid.~        3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.~      As the low mitotic activity and lack of blood supply cause little ability for the articular~     cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received~     much more attention due to its capacity to do self-healing in treatment of osteoarthritis of~     the knee.~      PRP consists of several concentrated growth factors in platelets of autologous blood that~     are applied to the different parts of medicine such as reconstruction of damaged tissue.~     Although platelets are well-known to involve in the blood clots formation, but current~     studies have shown that they secrete many bio-proteins which attract macrophages,~     mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate~     in healing procedure.~      This study is a prospective, randomized, controlled trial to assess The positive effects of~     platelet-rich plasma injection in 244 patients with osteoarthritis of the knee~   "
86412|NCT01926314|"~     Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and~     development of pelvic floor dysfunction. This may leed to devastating loss of function and~     quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor~     muscle training with the device PHENIX Neuromuscular Stimulation Therapy Systems on the~     recovery of pelvic floor function for primiparous women.~   "
86413|NCT01926301|"~     The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic~     shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular~     autoregulation.~      Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in~     patients with acute severe sepsis and septic shock.~   "
86414|NCT01926288|"~     The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate~     tablets in Chinese patients with hepatitis B~   "
86415|NCT01926275|"~     The aim of this study is to determine whether noninvasive positive pressure ventilation with~     inspiratory muscle training can improve quality of life and respiratory muscle strength than~     noninvasive positive pressure ventilation or inspiratory muscle training alone.~   "
86416|NCT01926262|"~     The aim of this project is to investigate, whether physical training, targeted neck and~     shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and~     crewmembers.~   "
86417|NCT01926249|"~     A Multicenter national prospective cohort study including at least 2300 individuals~     consecutively recruited from French Research Memory Centers and followed-up over 5 years.~   "
86418|NCT01926236|"~     The purpose of this study is to determine whether fit patients (with ECOG performance score~     of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the~     second-line setting (after prior therapy with cisplatin and gemcitabine) in terms of overall~     survival.~   "
86419|NCT01926223|"~     Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide~     home visiting program for first time parents aged 20 years and under. The evaluation uses a~     mixed-method design to assess participant outcomes in five program goal areas: 1) prevention~     child abuse and neglect; 2) optimal child development; 3) educational achievement and~     economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged~     births.~   "
86422|NCT01926184|"~     In the era of HIV treatment as prevention (TasP), efforts are needed to identify~     evidence-based combination prevention approaches that achieve greater decreases HIV viral~     load among populations that are more likely to engage in HIV transmission risk behavior.~     Because methamphetamine-using men who have sex with men (MSM) are at greater risk for~     acquiring and transmitting medication-resistant strains of HIV, interventions targeting~     stimulant use in this population of high-risk men could boost the effectiveness of TasP. At~     present, only conditional cash transfer approaches such as contingency management (CM) have~     demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who~     are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a~     positive affect intervention that is designed to optimize the effectiveness of CM to achieve~     long-term reductions in stimulant use and HIV viral load in this population. the~     investigators' team will examine the efficacy of this integrative intervention in a~     randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After~     enrolling in CM, participants will be randomized to receive either: 1) the positive affect~     intervention; or 2) a attention-matched control condition. Follow-up data will be collected~     at 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine~     the efficacy of an integrative intervention designed to promote long-term reductions in HIV~     viral load as the primary outcome. Secondary outcomes that will be examined include:~     increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+)~     count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention~     approach to decrease HIV viral load among methamphetamine-using MSM would substantially~     support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate~     HIV-related health disparities.~   "
86423|NCT01926171|"~     The purpose of this study is to evaluate the safety and efficacy of icotinib in combination~     with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint~     is objective response rate of intracranial lesions.~   "
86424|NCT01926158|"~     This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis~     drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant~     osseointegration (bone bonding) in postmenopausal women after total hip replacement. The~     patients with low bone mineral density (BMD) and those with normal BMD will be analyzed in~     separate groups. The investigators assume that denosumab prevents periprosthetic bone loss~     and enhances bone bonding of the hip stem in women with osteoporosis.~   "
86425|NCT01926145|"~     The objective of this study is to describe: 1) Differences in perceived health at hospital~     discharge between diagnostic groups and in-hospital predicting factors. 2) Perceived health~     at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) The~     association between perceived health, sick leave and health care utilization.~      The five heart centres in Denmark diagnose and treat about 50.000 patients with different~     diagnoses every year and offer both invasive and non-invasive treatment.~      Perceived health status is measured by self-reported health, quality of life, anxiety and~     depression and symptoms. Knowledge about perceived health status can help to guide inpatient~     practise and outpatient follow-up. Furthermore, it can be used to evaluate differences~     between diagnostic groups, regional differences and predicting factors for perceived health~     status at hospital discharge and long term morbidity and mortality. Also economic analysis~     of healthcare utilisation and work ability status are possible.~      Five Danish heart centres (Rigshospitalet, Gentofte Hospital, Odense University Hospital,~     Aarhus University Hospital and Aalborg University Hospital) are all including patients from~     April 2013 to April 2014. All patients discharged or transferred from one of the heart~     centres are potential participants in the study. Patients are unselected and consecutively~     included at hospital discharge. Included patients will be asked to complete and return a~     questionnaire before they leave the hospital.~      The following questionnaires will be used to measure the perceived health status of the~     patients at hospital discharge: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief~     Illness Perception Questionnaire, HeartQoL and Edmonton Symptom Assessment Scale.~     Furthermore 14 ancillary about health and health behaviour are included in the~     questionnaire. This amounts to a total of 62 items in the questionnaire.~      The DenHeart study data collection, database development and reporting of primary outcomes~     are funded by the five participating heart centres in Denmark. Further funding for registry~     data, analyses and reporting will be applied for in external funds.~   "
86426|NCT01926132|"~     Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids,~     proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA.~     Ascorbic acid was known to protect mitochondrial injury against oxidative stress by~     depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was~     suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function.~     There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The~     investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample~     may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The~     investigators will compare the mtDNA copy number and fatigue scale between moderate-severe~     fatigue patients and control group that had not malignant and chronic illness by a~     randomized controlled trial.~   "
86427|NCT01926119|"~     The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS)~     may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will~     test various methods of TMS in a small pilot study to investigate what methods may have~     clinical potential. This is a small pilot study to determine feasibility and signal to~     potentially inform future trials.~   "
86428|NCT01926106|"~     In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth~     would decrease the incidence of intubation or death in twin infants when compared to nCPAP.~   "
86429|NCT01926093|"~     We aimed to assess the accuracy of visual and quantitative analysis performed on low~     radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation~     dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment~     will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of~     the disease in ARDS patients.~   "
86430|NCT01926080|"~     Experts agree that neonatal death has long-term impact on parents. Many parents experience~     sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child.~     There are no prospective studies that evaluate the effectiveness of bereavement management~     and follow-up on the grief process following the death of a newborn. The purpose of this~     study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support~     program and the use of a newly designed family-centered bereavement DVD. This educational~     DVD includes personal interviews with parents, grandparents and siblings who have~     experienced the lost of a baby in the NICU.~   "
86431|NCT01926067|"~     Aim of the study: To validate accelerometers for continuous monitoring of global cardiac~     function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.~   "
86453|NCT01925781|"~     This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum~     for smoking cessation. Participants will be randomly assigned to either e-cigarette use or~     nicotine gum use during a quit attempt. All participants will have a one hour meeting with a~     tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be~     determined at 12 weeks after the quit date. Continued use of nicotine replacement (either~     e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be~     evaluated.~   "
86454|NCT01925768|"~     The purpose of this study is to determine whether apremilast is safe and effective for~     treating patients with psoriatic arthritis.~   "
86673|NCT01922895|"~     This study is being done to find out whether a diet supplemented with a probiotic nutrient~     can improve alcoholic hepatitis and gut complications compared to routine standard care.~   "
86432|NCT01926054|"~     This is an open-label, randomized, multi-center, Phase IV study of Acthar Gel in patients~     with biopsy-proven membranous (Class V) lupus nephritis (LN) aimed at providing~     proof-of-concept data that Acthar is a safe and effective therapy for membranous LN. Class V~     LN is a secondary form of membranous nephropathy, and occurs in 8-20% of patients with LN.~      Two different doses of Acthar Gel will be tested. The active intervention phase of this~     study will take place over 6 months, and follow-up will occur over the following 6 months.~     Efficacy and safety of the use of Acthar Gel for treatment of membranous LN will be assessed~     and analyzed throughout the course of the study by laboratory testing, physical exams, and~     other evaluation tools. Subjects will be closely monitored for adverse effects associated~     with the use of Acthar gel and if necessary study drug dosing will be reduced. The~     anticipated benefits to subjects are a complete renal response rate of 40% at 6 months~     showing superiority over the published complete remission rates of the currently used~     immunosuppressive therapies, and no unexpected toxicity signals.~      Pure Class V LN affects a significant number of systemic lupus erythematosus (SLE) patients~     and although it is less aggressive than proliferative forms of LN it still causes important~     renal and non-renal morbidity and mortality over time, especially in patients who remain~     nephrotic. The therapy of Class V LN is not clear, and currently used therapies are highly~     toxic because of immunosuppression, risk of infertility, and risk of future malignancy.~     Additionally, these therapies are only modestly effective in inducing remissions of Class V~     LN. There is thus an unmet need for a more effective and less toxic treatment for Class V~     LN.~   "
86433|NCT01926041|"~     Diabetes mellitus (DM) has been established to contribute to cardiovascular comorbidities,~     malignancies and higher mortalities. The management of DM is not limited to aggressively~     controlling sugar levels after the diagnosis; instead, should be emphasized more on~     effective modification for prediabetics. Smoking cessation were also demonstrated to improve~     insulin resistance. Nowadays, the 2nd-generation cessation program in Taiwan brings higher~     accessibility. However, there is little evidence on the long-term health outcomes of~     combining smoking cessation and coach-assisted lifestyle change for the prediabetics in the~     community.~      The present new project extends the original pilot project (NSC 102-2628-B-002-046-MY2 and~     MOST 104-2314-B-002 -072) from August of 2013. The investigators have been making efforts to~     promote this project by cooperating with primary care doctors of the community medical~     groups and corporate nurses. Over 446 prediabetic smokers will be enrolled by July of 2017.~     The invention includes smoking cessation clinics for up to 16 weeks (from January to~     December of 2017) and coach-assisted lifestyle change (from January of 2017 to July of 2020~     and later) for every participant joining intervention. The lifestyle coaches will help the~     participants in intervention group reach the goal of at least a 7 percent weight loss within~     the first 6 months. All smokers with prediabetes in intervention and self-management group~     are provided with educational materials for lifestyle change. All prediabetic smokers are~     prospectively followed up every 6 months till July of 2020 and later for smoking status,~     anthropometric indices and blood tests.~      Regarding the potential contribution to the national socio-economic development, this~     project will strengthen the motivation of smoking cessation in prediabetic smokers.~     Academically, cox regression will be used to investigate the effectiveness of the smoking~     cessation combined with coach-assisted lifestyle change on DM prevention in smokers with~     prediabetes. This prospective project will contribute to community-based diabetes research~     in preventive medicine.~   "
86434|NCT01926028|"~     This is a multi-center, randomized, double-blind, placebo-controlled study intended to~     assess the safety, tolerability and humoral and cellular immune response over a 12-month~     period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In~     addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of~     vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated~     relative to placebo.~   "
86435|NCT01926015|"~     The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and~     Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260)~     in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates~     to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with~     staggered administration of RotaTeq™.~   "
86436|NCT01926002|"~     The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline~     early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr)~     of forced expiratory volume (FEV1) when compared to placebo.~   "
86437|NCT01925989|"~     This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each~     period, participants will receive once daily injections of stable dose LY2605541 or insulin~     glargine for 28 to 35 days followed by procedures to look at how the body uses or stores~     fats and sugars. Participants will continue to use meal time insulin throughout the study.~     Healthy participants will also enroll in the study. They will not receive any study~     medication.~   "
86438|NCT01925976|"~     The purpose of this study is to implement an individualized, face-to-face, parent supported~     and school-partnership dietetic intervention program to promote healthy eating habits in~     obese, Hispanic, children from low socioeconomic status due to the high predisposition to~     unhealthy eating habits and obesity in this population.~   "
86439|NCT01925963|"~     The purpose of the research study is to collect information about brain function and~     structure among active duty military personnel or civilians who are healthy. Researchers~     want to develop a database from normal volunteers that will be used in comparison with a~     similar database from active duty military with post-concussive syndrome (PCS) from a mild~     traumatic brain injury. Findings from this study may be used to design larger studies that~     will evaluate whether hyperbaric oxygen treatments actually improve PCS.~      Participants in this study will undergo numerous tests to assess physical, mental, and~     intellectual health and how they might change over time. Participants will wear heart and~     activity monitors, undergo brain imaging, provide blood and urine for laboratory testing,~     and have vision, hearing, balance, and muscle function tests. They will also complete a~     number of questionnaires and interviews. This battery of tests will be repeated twice more~     over the course of 6 months.~   "
86440|NCT01925950|"~     Use of an oral topically-active glucocorticoid with limited side effects may control the~     gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.~   "
86441|NCT01925937|"~     The aim of this study is to compare the effect of addition of combination of~     Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus~     addition of Atorvastatin alone on CHF outcomes.~   "
86455|NCT01925755|"~     This is local prospective multicenter observational non-interventional local study. Primary~     study objective is investigate and describe prescription pattern of neurologists in~     secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in~     patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack)~     who treat with rivaroxaban at an initial visit and three follow-up visits.~   "
86442|NCT01925924|"~     Demineralization during orthodontic (brace) treatment is a common clinical problem leading~     to unsightly white or brown marks on the teeth. A recent systematic review has shown little~     evidence that current methods of delivering fluoride are effective at reducing this problem.~      Design: A multi-centre randomised single blinded controlled clinical trial will be conducted~     with two parallel groups.~      Setting: The trial patients will be treated by eight named operators on the Specialist List~     for Orthodontics held by the General Dental Council and who work either within the hospital~     service or specialist orthodontic practice. The sample size calculation suggests that each~     operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to~     10 familiarisation patients before.~      Planned trial interventions: Brackets will be bonded to all teeth in front of the first~     permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a~     light cured composite control (Transbond). The material to be bonded will be allocated~     randomly.~      Outcome measures: The two main outcome measures will be the difference in demineralization~     of the anterior teeth before and after treatment assessed from photographs and the number of~     debonded brackets during treatment.~   "
86443|NCT01925911|"~     To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A~     (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with~     midazolam in healthy subjects.~   "
86444|NCT01925898|"~     Sedation is often needed for young children undergoing minor procedures in the emergency~     department (ED). Oral midazolam is one of the most commonly used regimens for children~     undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only~     one randomized controlled study oral ketamine has been used successfully for procedural~     sedation for laceration repair. A recent study showed that the combination of oral midazolam~     and oral ketamine provided deeper sedation compared with oral midazolam alone. However~     children treated wuth the combination of midazolam and ketamine required longer recovery~      Hypothesis:~      Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation~     for laceration repair.~   "
86445|NCT01925885|"~     -  Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or~          eliminate clinical atrial fibrillation in subjects with accepted indications for~          catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.~        -  Summary: This is a prospective randomized study to assess the safety and effectiveness~          of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for~          the treatment of symptomatic paroxysmal atrial fibrillation.~   "
86446|NCT01925872|"~     1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.~        2. Genetic polymorphisms are the most important factors to clopidogrel resistance.~        3. The purpose of this study is to find the genes which are the related to clopidogrel~          resistance.~        4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another~          drug maybe used to avoid the undesired efficacy.~   "
86447|NCT01925859|"~     To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone~     sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy~     volunteers, based on plasma concentrations of dexamethasone.~   "
86448|NCT01925846|"~     Microbial infection of the cornea, also known as microbial keratitis, causes severe corneal~     inflammation that could result in permanent visual loss. Contact lens wear is the strongest~     risk factor related to microbial keratitis in developed countries. The most commonly~     isolated pathogen of contact lens associated microbial keratitis (CLMK) is Pseudomonas~     aeruginosa, which accounts for over one third of the cases. Among the various virulence~     factors involved in the pathogenesis of pseudomonal keratitis, a secretion system known as~     type three secretion system (T3SS) secretes toxins that damage the host cells. ExoS is a~     bifunctional exotoxin with GTPase-activating protein (GAP) activity and ADP ribosyl~     transferase (ADPRT) activity. It results in an invasive phenotype of P. aeruginosa causing a~     relatively slower host cell death with intracellular invasion and possibly proliferation of~     bacterium. In contrast, ExoU expressing strains carries a cytotoxic phenotype that causes~     rapid host cell lysis due to its phospholipase activity. Previously, cytotoxic strains were~     reported to be more commonly found in patients with pseudomonal keratitis and were highly~     correlated with multidrug resistance.~      In order to understand the pathogenesis of CLMK, especially pseudomonal related CLMK, we~     proposed to recruit 180 volunteers who will wear different contact lens materials. We then~     collect the used contact lens and analyze 1) the microbiota on the used contact lens; 2) the~     bacterial-contact lens adhesion of wild strains, pscC mutant strains (T3SS needle-comples~     mutant), cytotoxic strain, and invasive strain P. aeruginosa; 3) the effect of shearing~     forces on bacterial-contact lens adhesion; 4) the bacteriocidal effect of multipurpose~     solution on different strains of P. aeruginosa.~   "
86449|NCT01925833|"~     Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with~     careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g.~     <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon~     is in different conformation during insertion and withdrawal phases. We think careful~     inspection and polypectomy during both insertion and withdrawal can improve adenoma~     detection rate.~   "
86450|NCT01925820|"~     Currently, there are several antiviral treatments effective for suppression of viral~     replication but still failed to cure HBV infection in patients with chronic hepatitis B~     (CHB). Seven drugs have been worldwide approved for the treatment of CHB at present:~     conventional IFN (IFN) alfa, lamivudine (LAM), adefovir dipivoxil (ADV), pegylated IFN~     (Peg-IFN) alfa, entecavir (ETV), telbivudine (LdT) and tenofovir (TDF). Conventional or~     Peg-IFN alfa monotherapy has a narrow range of efficacy, is associated with several adverse~     effects and is inconvenient because of frequent injections. Oral nucleot(s)ide analogues~     (NA) are better tolerated; but virologic response to NA is frequently not durable and~     prolonged treatment is associated with the emergence of drug-resistant HBV mutants.~      Although the best treatment choice for CHB is not clarified yet, certain therapeutic~     concepts could be derived from the experience of treating patients with chronic hepatitis C~     or human immunodeficiency virus (HIV) infection. A major advancement in treating hepatitis C~     or HIV infection has been the development of combination therapy. Combination therapy has~     ever been investigated in patients with CHB, but again the optimal strategy remains to be~     identified. Entecavir, a carbocyclic deoxyguanosine NA, is one of the most potent anti-HBV~     agents ever discovered. In addition, the 6-year drug resistance rate is 1.2% in selected~     lamivudine-naïve cohorts. Pegylated interferon alfa-2a possesses both antiviral and~     immunomodulatory effects. Overall, satisfactory virologic and serologic responses could be~     achieved using pegylated IFN alfa in around 30-44% of these patients. Whether the~     combination therapy using Peg-IFN alfa-2a plus ETV can achieve a long-term beneficial effect~     against ETV or Peg-IFN alfa-2a alone is not clarified. A prior single-arm pilot study~     suggested that similar combination therapy may be beneficial in patients with CHB. In this~     proposal, the investigators thus hypothesize that the efficacy by using combination therapy~     with Peg-IFN alfa-2a plus prolonged ETV is superior to that by using ETV or Peg-IFN alfa-2a~     alone in that Peg-IFN may restore host immunity against HBV and prolonged ETV can maximize~     viral suppression.~      The objective of this clinical trial is to evaluate the efficacy of the combination of~     Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg~     daily for 48 weeks followed by ETV 0.5 mg daily monotherapy for an additional 96 weeks~     versus ETV 0.5 mg daily monotherapy for 144 weeks or Peg-IFN alfa-2a 180 mcg per week for 48~     weeks in patients with HBeAg-negative CHB. It will be an open-label, randomized,~     comparative, multi-center clinical trial. The recruited patients will be equally randomized~     into three treatment groups. Treatment-free follow-up period will be 48 weeks in both groups~     of patients. The primary parameter is the Simultaneous achievement of HBsAg titer below 100~     IU/ml and HBV DNA below 300 IU/ml at 144 weeks after start of treatment, by an~     intention-to-treat analysis. Genotypic and virologic resistance to ETV will also be assessed~     at baseline and at end of years 1, 2 and 3.~      The investigators anticipate that the rate of HBsAg <100 IU/mL plus HBV DNA <300 IU/mL at 3~     years of the study period will be 30% for patients receiving Peg-IFN therapy and increased~     to be 45% for patients receiving Peg-IFN plus entecavir therapy. With a 5% nominal~     significance level (two-sided), 163 patients per group under a 1:1:1 ratio will provide 80%~     power to detect a difference of 15% in treatment response rates between group I and III.~     Because this will be a 4-year study for each patient, the investigators thus anticipate that~     the dropout rate may be as high as 10%. Accordingly, a total of 540 (180x3) patients will be~     recruited, in order to account for a dropout rate of up to10%.~   "
86451|NCT01925807|"~     Suicide is the second leading cause of mortality for Canadian adolescents. Mental health~     complaints are one of the leading reasons for an emergency department visit at the~     Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The~     goal of the present investigation is to test the efficacy of a brief group intervention for~     adolescents with passive suicidal ideation and their caregivers that will focus on coping,~     familial support, and emotional regulation. The investigators hypothesize that a brief group~     intervention, delivered in the weeks following presentation for crisis services, will reduce~     suicidal ideation and improve coping and familial support.~   "
86452|NCT01925794|"~     This is a prospective, multi-center, non-randomized, single arm clinical trial that will be~     conducted at up to 40 sites in the United States and Outside United States (OUS). This study~     will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion~     contained within a native coronary artery with reference vessel diameter between 2.5 mm and~     4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention~     (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1~     year and annually for 5 years post index stenting procedure.~   "
86456|NCT01925742|"~     Each year, 450,000 Canadian women become pregnant and, as a result of their participation in~     prenatal screening for Down syndrome, approximately 10,000 of them will have an~     amniocentesis (i.e. sampling of liquid surrounding the fetus) and of those, 315 will be~     found to carry a baby with Down syndrome and 70 normal pregnancies will be lost from~     complications of the procedure. It has been discovered recently that, during pregnancy,~     there is fetal DNA in maternal blood in sufficient quantities to be analysed and methods~     have been proposed to detect the presence or not of a fetus with Down syndrome using~     maternal blood. The introduction of genomic blood testing as proposed in the context of this~     project could lead to increased detection of Down syndrome, less invasive screening with~     9700 amniocentesis avoided each year in Canada, improving the peace of mind of pregnant~     women, and preventing the accidental loss of 70 normal fetuses, at a lower overall cost than~     current practice. However, these methods still need to be validated before being~     appropriately introduced in routine care.~      The study hypothesis is that new genomics-based non-invasive methods using fetal-DNA in~     maternal blood during pregnancy can be more effective than current prenatal screening~     methods for fetal aneuploidy.~      This project will carry out an independent study that will validate the performance and~     utility of different new genomic technologies for screening in pregnant women using maternal~     blood. The team of researchers will compare the real-life performance of different~     non-invasive assays and strategies to screen for fetal aneuploidy, and identify an~     evidence-based cost-effective approach for implementation of this new technology in the~     Canadian health care system. The deliverables of this project will enable decision makers,~     pregnant women and their partner to make informed choices pertaining to prenatal genetic~     screening and diagnosis, such as screening for Down syndrome, and reduce the risk to~     pregnancies associated with amniocentesis.~   "
86457|NCT01925729|"~     This study will determine if exposure to an allergy material (ragweed) or exposure to an~     allergic-symptom-provoking substance (histamine) and medications typically used to decongest~     the nose changes the rate of blood-flow in the lining of the middle-ear. Otitis media (the~     build-up of water-like fluid in the middle-ear airspace) may occur if the blood flow in the~     lining of the middle-ear is too high and may be prevented if a way could be found to lower~     the blood flow in persons susceptible to the disease. Middle-ear blood flow is measured~     indirectly by measuring the change in middle-ear pressure while a person breathes a gas~     mixture containing nitrous oxide (laughing gas). In this study, 4 groups of subjects will~     be entered and middle-ear pressure in persons breathing a mixture of 50% Oxygen, 50% Nitrous~     Oxide (laughing gas)will be measured after exposure to one of four substances (ragweed,~     histamine,an oral decongestant, a decongestant nasal spray) and a fake medication (placebo)~     at separate test sessions. All subjects will have one set of 2 x-rays of the middle ears and~     mastoids. The group exposed to ragweed will require 3 study visits while the other 3 groups~     will have 2 study visits. From this information middle-ear blood flow will be calculated.~     This will help determine the relationship between what happens in the nose and what happens~     in the middle ear.~   "
86458|NCT01925716|"~     The objectives of this clinical trial are to assess the effects of dietary oils on blood~     lipids and other aspects of the fasting lipoprotein profile in healthy men and women with~     elevated cholesterol~   "
86459|NCT01925703|"~     Intravenous iron replacement has been shown to benefit patients with heart failure and iron~     deficiency, but the weekly outpatient regimens studied to date are impractical for many~     patients. Our purpose is to evaluate the short-term effects and safety of an accelerated~     intravenous iron regimen in hospitalized patients with these two conditions.~   "
86460|NCT01925690|"~     As many as 50% of MS patients prematurely discontinue their disease modifying medications.~     For this study, we will develop a telephone-based talk therapy intervention and then conduct~     a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute~     telephone sessions of psychotherapy or a brief education control condition. We hypothesize~     that patients undergoing phone therapy will be more likely to indicate they are interested~     in resuming taking disease modifying medications than patients given brief education and~     treatment as usual.~   "
86461|NCT01925677|"~     Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci~     instrumentation and Single-Site platforms.~   "
86462|NCT01925664|"~     The goal of this study was to evaluate the impact of a doula home visiting intervention on~     young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms,~     and parenting, and on their children's development.~   "
86463|NCT01925651|"~     The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy~     after mastectomy, in relation to the time of treatment interruption and acute effects. This~     study evaluates whether there is an increase in treatment time with the addition of the~     bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous~     tissue.~   "
86464|NCT01925638|"~     The purpose of this study is to see if there is a difference between the way your body~     absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a~     drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the~     body~   "
86465|NCT01925625|"~     HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late~     stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.~   "
86466|NCT01925612|"~     This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and~     efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL that~     have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP~     together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there~     is a difference in side effects between the 2 groups.~      The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab~     vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~     (known as BV+RCHP) in patients with CD30-positive DLBCL that have never been treated.~     Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.~      The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared~     to standard RCHOP in patients with CD30-positive DLBCL that have never been treated.~     Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP.~     Patients will be tested to see if there is a difference in side effects between the 2~     groups.~   "
86467|NCT01925599|"~     The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal~     melanoma for a germline BAP1 mutation and other genetic markers associated with developing~     malignancy as well as additional sequencing of the uveal melanoma genome.~   "
86468|NCT01925586|"~     This study is designed to look at whether it is feasible to observe women with atypical~     ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.~   "
86492|NCT01925261|"~     This one-year study is designed to investigate the safety and efficacy of TPX-100, a~     23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration~     of knee cartilage in subjects with bilateral osteoarthritis of the knee.~   "
86469|NCT01925573|"~     This protocol is designed to generate and provide preliminary data to determine the safety~     and activity of combination therapy using tumor treating fields (TTFields;~     Optune(NovoTTF-100A); Novocure, Haifa, Israel), a novel FDA-approved therapy utilizing~     alternating electric fields to inhibit tumor cell growth, along with bevacizumab (Avastin;~     Genentech, San Francisco, CA), a humanized monoclonal antibody that inhibits vascular~     endothelial growth factor (VEGF), and hypofractionated stereotactic radiotherapy, a~     highly-focal abbreviated course of brain irradiation, in the treatment of patients with~     bevacizumab-naive recurrent GBM. Each of these individual therapies, and also several~     combinations in doublets, has already demonstrated safety and efficacy but prospective~     clinical data for the concurrent combination of all three therapies are lacking.~   "
86470|NCT01925560|"~     The objective of this study is to assess the tolerance and utilization of agave inulin. This~     will be accomplished through analyses of breath and fecal samples to quantify fermentation~     end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and~     short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial~     populations will also be measured in fecal samples.~   "
86471|NCT01925547|"~     The purpose of this study is to investigate the effect of micellar curcumin on inflammation~     and lipid metabolism markers in subjects at risk for the metabolic syndrome.~   "
86472|NCT01925534|"~     The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen~     delivery system, is superior to standard oxygen therapy during breaks off noninvasive~     ventilation in patients affected by acute respiratory failure and in respiratory distress.~     The investigators anticipate that the Optiflow will provide oxygen more effectively, be more~     comfortable and permit longer breaks off NIV, shortening the total duration of NIV.~   "
86473|NCT01925521|"~     The objective of this trial is to evaluate the safety and tolerability of single and~     multiple ascending oral doses of OPS-2071 in healthy male Korean~   "
86474|NCT01925508|"~     The purpose of this study is to verify that the implementation of a protocol physiotherapy~     musculoskeletal pain and reduces anxiety and improves quality of life in patients~     hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao~     Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed~     preeclampsia. Where patients will be recruited, answered questionnaires before and after~     application of physiotherapy protocol.~   "
86475|NCT01925495|"~     This is a study to determine if there are reflexes that detect changes in eardrum position~     or in the pressure of middle-ear gases and respond with changes in the ease by which the~     Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle~     ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles~     that surround the tube. If the Eustachian tube does not open frequently enough, the pressure~     in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing~     a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its~     pressure. There is some evidence that the changes in eardrum position and middle-ear~     pressure when the Eustachian tube does not open frequently enough can be detected by the~     brain that, in turn, sends signals to the Eustachian tube and its muscles to make Eustachian~     tube opening easier. In this study, we will test this possibility.~      Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and~     out, apply different pressures to the middle ear, or change the composition of the gases in~     the middle ear while we measure how difficult it is to open the Eustachian tube by~     increasing middle-ear pressure or by measuring the readiness of the Eustachian tube~     muscles to contract and open the tube.~   "
86476|NCT01925482|"~     This study will measure the speed at which gases move between the middle-ear air-space and~     the blood flowing through the middle-ear lining. The middle ear is a rigid biological gas~     pocket located behind the eardrum and is filled with the same gases as in air, primarily~     oxygen (O), nitrogen (N) and carbon dioxide (CO2), but in different proportions. The middle~     ear is lined by a thin layer of cells overlying tissues that surround blood vessels. The~     blood that flows through the middle-ear lining also contains these same gases but at~     different proportions from both the atmosphere (room air) and middle ear. Because of the~     differences in the proportions of these gases, each gas tends to flow between the middle ear~     and blood trying to make the proportions of gases in those compartments the same. This flow~     of gases to and from the middle ear changes the middle-ear pressure. If the middle-ear~     pressure decreases much below the air pressure of the atmosphere, the ability to hear sounds~     is impaired and fluid can build up in the middle ear. It is expected that each different gas~     will move between the middle ear and blood at a different speed, but it is not known what~     those speeds are for any of the gases. It is also expected that those speeds will be~     different for ears that have had middle-ear disease and those that have not. In this study,~     we will measure the speed of nitrogen, oxygen and carbon dioxide exchanges in both~     directions between the middle ear and blood. To do this, the gas mixture in the middle ear~     will be changed so that there is movement of only one gas for each experiment and then~     measure the change in the amount of the gas in the middle ear. This can be done using a~     special instrument called a mass spectrometer if there is an open, working tympanostomy~     (ventilation) tube, a small plastic tube, in the eardrum. For all participants in this~     study, we will conduct 6 experiments lasting about 2 hours each to measure the speed of~     nitrogen, oxygen and carbon dioxide flow. Subjects with and without tympanostomy tubes will~     be recruited. Those without a tube will have a tube inserted in one ear for study purposes~     and it will be removed at the end of the study; these subjects will be followed weekly until~     the hole in the eardrum (where the tube was) is closed.~   "
86477|NCT01925469|"~     The objective of this study is to assess the utility of benzocaine spray versus a placebo~     spray in alleviating pain during and after hysterosalpingogram (HSG).~   "
86478|NCT01925456|"~     A. Objectives & Hypothesis Overactive bladder (OAB) affects over 10 million adults in the~     United States and each year substantial costs are incurred from private and public funds to~     test the efficacy of new and existing drugs for OAB.14 However, effectiveness and adherence~     data from traditional clinical trials are not generalizable to clinical practice.3, 4 In an~     era of limited resources and competing demands, it is essential that cost-effectiveness data~     from clinical trials be generalizable to the clinical world. Pragmatic clinical trials~     measure the effectiveness of treatments in real clinical practice, and in the full spectrum~     of patients that require treatment.5 Pragmatic trials require patient reported outcomes that~     are valid but have low patient burden.5 The conduct of pragmatic clinical trials for OAB has~     been limited by a lack of instruments that have demonstrable validity and reliability in the~     typical clinical setting Pill counts, used to measure primary outcomes in most traditional~     trials, are burdensome in the clinical setting.1610 The optimal instrument for measuring~     utility scores, general quality of life scores for cost-effectiveness analyses for OAB, is~     also not known.~      Although poor adherence carries the potential for continued suffering for patients and~     wasted health care resources, there is a lack of data on the clinical and economic impact of~     poor adherence to treatment for OAB in real-world clinical practice. We have published~     preliminary data that underscores the role of adherence and utilities in the treatment of~     OAB. 3 Our hypothesis is that effectiveness, adherence, and utility preference scores can be~     measured using pragmatic patient reported instruments and that poor adherence is associated~     with lower effectiveness and quality of life in adults with OAB in a clinical setting.~     Specifically, the overriding goal of this proposal is to validate pragmatic instruments to~     measure effectiveness, adherence and utility preference scores and obtain preliminary data~     on the effect of adherence and quality of life in adults undergoing treatment for overactive~     bladder in a clinical setting.~   "
86479|NCT01925443|"~     The low level laser therapy is able to improve immediately and long term (after 4 weeks of~     treatment, 3 days per week resulting in 12 applications of low level laser therapy)~     isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular~     work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric~     isokinetic quadriceps femoris muscle in subjects with diabetes mellitus~     non-insulin-dependent.~   "
86480|NCT01925430|"~     A new device is being developed to screen for sleep-breathing disorders. Within this device~     is a new software algorithm which will determine sleep/wake states. The aim of this study is~     to evaluate the performance of this new algorithm. This prototype will be compared against a~     commercially available device which monitors sleep/wake patterns. Volunteers will be asked~     to wear the prototype and comparative devices for 1-2 nights. The data from both devices~     will be downloaded after the completion of the study and analysis wil be performed to~     compare the two recordings.~   "
86481|NCT01925417|"~     This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as~     a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the~     primary symptom of recurrent Clostridium difficile infection. All eligible subjects will~     receive RBX2660.~   "
86482|NCT01925404|"~     Encouraging greater levels of physical activity is critical to improving health among~     Americans, who are largely sedentary. Neighborhood parks are resources for physical activity~     that are available to most Americans within a couple miles of their homes, yet many~     residents are unaware of the programs and facilities available. Previous research indicates~     that park use is related to park programming and outreach. Because funding for parks is~     limited, low-cost interventions are needed to attract more people to parks to engage in~     moderate-to-vigorous physical activity. While many community-based organizations would like~     to invest in efforts that increase physical activity, few low-cost park programs are~     documented to be both scalable and cost-effective. Effective programs that can be replicated~     to make population-level impacts are needed. The goal of this study is to develop and test 2~     low-cost community-level approaches, free exercise classes vs. a frequent user program, to~     promoting physical activity, singly and in combination, in 48 park settings in Los Angeles~     low-income neighborhoods.~   "
86483|NCT01925391|"~     Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the~     eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the~     optic nerve, cornea and other structures. Accurate intraocular pressure measurements in~     young children is often impossible to obtain in an office setting. Children need sedation or~     general anesthesia to determine IOP. All volatile general anesthetics affect the IOP.~     Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since~     Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we~     want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.~   "
86484|NCT01925378|"~     Preliminary data showed that Nelfinavir has selective apoptotic effects on HPV+ cervical~     tumor cell lines. Furthermore, in a Phase I clinical trial, the combination of NFV and~     chemoradiotherapy showed acceptable toxicity and promising activity in patients with~     pancreatic cancer. Therefore, for the proposed research, the principal investigator will use~     a single-arm Phase II intervention trial study design with focus on the efficacy of NFV to~     induce complete or partial remission of CIN 2/3 or CIN 3 as well as biomarker evaluation.~   "
86485|NCT01925365|"~     Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia~     and heart disease, however the mechanisms by which oats or oat fractions exert this effect~     is not totally clear. Furthermore, several large epidemiological studies and a number of~     recent meta-analyses of nutritional interventions have reported a positive association~     between increased whole grain intake and reduced risk of developing a range of chronic~     diseases. Recognising the important role of the gut microbiota in metabolism and metabolic~     disease risk, we examined the impact of whole grain oats on the human gut microbiota and~     cardio-metabolic risk factors.~      The main aims of this human study is to determine the effectiveness of a low GI whole grain~     oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially~     modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and~     inflammation markers in an at risk of cardio-metabolic disease population~   "
86486|NCT01925352|"~     To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF)~     treatment in ischemic heart disease.~   "
86487|NCT01925339|"~     The purpose of this study is to compare two different timings of restoring dental implants~     that are placed right after tooth extraction: The test group will have the provisional crown~     placed at the time of implant placement. The control group will have the tooth removed and~     the implant placed at the same appointment but restorations placed after 4 months. Both~     procedures currently are accepted methods for replacing missing teeth but direct comparisons~     of the two procedures are lacking. The results of this study should aid clinicians in~     selecting the best timing for restoring implants for their patients. The hypothesis is that~     immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.~   "
86488|NCT01925313|"~     Study objectives~        -  To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine~          besylate after a single oral administration in healthy male volunteers.~        -  To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral~          administration in healthy male volunteers.~   "
86489|NCT01925300|"~     This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and~     rosuvastatin in healthy male volunteers.~   "
86490|NCT01925287|"~     Background: The oral bioavailability of curcumin is low due to its limited intestinal~     uptake, rapid metabolism and excretion from the body. Considering its potent reported~     health-beneficial properties, researchers have tried to increase its bioavailability as a~     means to enhance its biological activities.~      Objective: The aim of the project was to develop novel curcumin formulations with enhanced~     oral bioavailability and to study the safety of the formulations and potential~     sex-differences in humans.~      Design: In this single-blind crossover study with three arms separated by ≥1-week washout~     periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in~     random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or~     liquid micelles. Blood and urine samples were collected in intervals for 24 h and total~     curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.~   "
86491|NCT01925274|"~     This study will investigate whether the combination of PF-05212384 plus Irinotecan improves~     progression free survival in patients with KRAS and NRAS wild type metastatic colorectal~     cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in~     Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients~     enrolled at Japanese sites.~   "
86494|NCT01925235|"~     Patients with impaired renal function are at elevated risk for development of acute kidney~     injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and~     mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning~     (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in~     patients undergoing elective coronary angiography.~      The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote~     ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter~     aortic valve implantation (TAVI).~      Patients with impaired renal function undergoing TAVI will be evaluated in respect whether~     they received remote ischemic preconditioning before the procedure or not. This study will~     give insight if RIPC might be beneficial in these patients.~   "
86495|NCT01925222|"~     The purpose of this study is to assess the direct effects of the ten-valent pneumococcal~     conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.~      These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive~     pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov~     Identifier:NCT00861380) during 2009 to 2011.~      Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder~     non-vaccinated siblings aged 5 to 9 years.~   "
86496|NCT01925209|"~     To evaluate the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs~     placebo, when administered intravenously (i.v.), on physical function, muscle strength, and~     mobility in patients with sporadic inclusion body myositis (sIBM)~   "
86497|NCT01925196|"~     Background:~      - Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis~     (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat~     itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those~     families, some persons have ALS and others have FTD. Occasionally the C9ORF gene mutation~     occurs in persons without a family history. Researchers want to understand how this gene~     causes different diseases. They will study how symptoms caused by the C9ORF gene develop and~     change over time. They will measure symptoms that occur in ALS and in FTD. In particular,~     they will measure strength, ability to move, thinking, and memory. They will also see if~     other tests are associated with progression of disease. These tests, called biomarkers, may~     help detect or measure C9ORF72 disease in the future.~      Objectives:~      - To understand how symptoms change over time in people with mutations in a gene called~     C9ORF72, which causes ALS and FTD.~      Eligibility:~      - Adults over age 18 who have this genetic mutation~      Design:~        -  Participants will have up to 4 in-person visits and 3 telephone interviews over 3~          years. Each in-person visit may take place over several days. They may be either~          inpatient or outpatient visits.~        -  At each visit, participants will undergo a series of brain, language, and behavior~          tests. These will include:~        -  Magnetic resonance imaging (MRI) of the brain. This uses magnets, radio waves, and~          computers to produce detailed pictures of the brain.~        -  Collecting spinal fluid. The clinician will make the participant s back numb and then~          insert a needle to collect fluid.~      <TAB>- Blood samples will be taken.~      <TAB>- Participants will be asked to perform several language and movement tests.~      <TAB>- Small skin samples will be taken on one visit~      - Between visits, participants will answer questions about their health over the phone 3~     times.~   "
86498|NCT01925183|"~     Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated~     interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative~     patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive~     patients, a fixed treatment duration of 48 weeks is used.~      The aim of this study is to assess efficacy and safety of response-guided triple-therapy~     with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment~     duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All~     patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at~     W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total~     treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44~     weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.~   "
86499|NCT01925170|"~     A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive~     than mammography for detecting breast cancer in women with dense breasts. The purpose of~     this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on~     mammography.~      Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal~     or higher positive predictive value than SM in women age 40 and older with mammographically~     dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously~     achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive~     rate (specificity >90%) that permits its use as a screening tool in this patient population.~   "
86500|NCT01925157|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     LY3090106 in healthy participants and in participants with RA who are having an inadequate~     response to methotrexate (MTX). The study will investigate how the body processes the study~     drug and how the study drug affects the body. The study will last about 3 months for each~     participant.~   "
86501|NCT01925144|"~     The main purpose of this study is to find out how the body will react to a study drug called~     baricitinib when taken with another drug called omeprazole.~      For each participant, this study will include 2 periods in fixed order. The study will last~     approximately 25 days, not including screening.~   "
86502|NCT01925131|"~     This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when~     given together with combination chemotherapy in treating patients with relapsed or~     refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer~     cells that express cluster of differentiation (CD)22 and kill them without harming normal~     cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and~     prednisone, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with~     combination chemotherapy may kill more cancer cells.~   "
86503|NCT01925118|"~     Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall~     response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In~     addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or~     renal cell carcinoma with a durable response in patients who achieved complete remission.~     Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic~     anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.~   "
86517|NCT01924936|"~     In the United States in 2010, 38,000 people died from suicide and it is our nation's 10~     leading cause of death. Suicide prevention is a national priority and yet secondary~     prevention programs targeting those most at risk are lacking. The purpose of the current~     research is to develop and pilot test three promising suicide prevention programs that, if~     found acceptable to high-risk individuals, could be further evaluated and eventually offered~     broadly and affordably to the public.~   "
86504|NCT01925105|"~     Like most developed countries the population of Sweden is getting older and consequently the~     number of individuals with chronic diseases will be an increasing challenge for its~     healthcare system. To improve care of the frail elderly, wards with a coordinated~     multidisciplinary team and multidisciplinary mobile teams were established several years~     ago. Treatment and follow up is planned in accordance to the patients' medical,~     psychological and functional capabilities (Comprehensive Geriatric Assessment = CGA). There~     are to our knowledge only few studies concerning CGA applicable to Swedish conditions. We~     plan to conduct a Swedish study that evaluates if care and treatment with a modified~     CGA-model in an outpatient setting can improve quality of life for frail older people.~   "
86505|NCT01925092|"~     Study objectives are to obtain safety, pharmacokinetic, and pharmacodynamic data on the~     effect of mifepristone on glucose metabolism, body weight and the growth-hormone-IGF in~     children with refractory Cushing's disease.~   "
86506|NCT01925079|"~     Among the patients with coronary heart disease, those with ACS (acute coronary syndrome) are~     extremely high-risk patients. Therefore, management outside hospital, especially the regular~     administration of drugs, is vital to prevent the recurrence of cardiovascular events.~     However, most patients often fail to stay on a long-term administration regimen, especially~     the administration of statins. According to the statistics, the average duration adhered~     with statin in patients with ACS is less than 3 months, use of statin at hospital discharge~     was only 80% and 65% in 6 month, with a very low LDL-C control rate (about 11% at 6 months),~     which poses a threat to the recurrence rate of cardiovascular events in patients with ACS.~      It was found in previous studies that there were many factors influencing patients'~     compliance, in which patients' refusing to take medicine accounted for a higher proportion.~     It suggests that patient had not recognized the importance of long-term administration.~     Therefore, it is extremely important for physicians to strengthen patient education and~     regular follow-up visits during disease management. Moreover, the effectiveness of patient~     education during chronic disease management has already been proved in some studies abroad,~     and the interventional effect of multiple patient education process outweighs that of single~     approach education.~      Thus, we intend to conduct a randomized and controlled study to explore the effect of~     multi-channel intensive patient education on LDL-C target achieving rate and statin~     adherence in patients with ACS in China.~   "
86507|NCT01925066|"~     The purpose of this study is to determine whether aerosolized vancomycin is effective in the~     treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical~     ventilation.~   "
86508|NCT01925053|"~     This exploratory study is designed to compare the gastric layering and rates of emptying and~     by inference rates of digestion of a Palaeolithic inspired meal and a reference meal. Two~     types of meals, one high in fruit and vegetables will be used, and one based on WHO~     nutritional guidelines. Previous data suggests that the former meal releases nutrients more~     slowly than the latter. On each of two study days, a total of 11 MRI scans will be taken, 1~     baseline and 10 post meal, to assess gastric layering and emptying. Participants will also~     be asked to complete a questionnaire at predetermined times to assess feelings of satiation.~   "
86509|NCT01925040|"~     The purpose of this study is to compare the clinical performance of a new resin based~     filling material to an established resin-based filling material in posterior teeth at 2~     different study centers.~   "
86510|NCT01925027|"~     Our hypothesis is to test that 1) The safety and efficacy of Nano+ DES in patients with de~     novo lesions; 2) A low neointimal hyperplasia after Nano+ DES implantation due to its~     effective and sufficient antiproliferative drug; 3) A very high coverage and an improved~     early arterial healing after Nano+ DES implantation due to polymer-free; 4) The safety of~     clopidogrel treatment discontinuation at 3 months when OCT results are defined as optimal.~   "
86511|NCT01925014|"~     To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed~     tomography (CT) as the first-line imaging test in adolescents and young adults in regard to~     negative appendectomy rate (NAR).~   "
86512|NCT01925001|"~     Sickle Cell disease is caused by an inherited hemoglobin disorder. Healthy red blood cells~     are discoid and can deform and move through small blood vessels to carry oxygen to all parts~     of the body. In Sickle Cell disease, as red blood cells circulate and oxygen is released,~     the deoxygenated abnormal Hemoglobin S can begin to polymerize and cause red cells to become~     sticky and elongated. These sickled red cells are less flexible and will obstruct small~     blood vessels and prevent normal red cells from circulating freely, which limits oxygen~     delivery to tissues and organs. This is known as a sickling crisis or vaso-occlusive~     crisis and is the leading cause of hospitalization in patients with Sickle Cell disease.~      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,~     heart attack or even death. Current therapy is limited to hydration and symptomatic pain~     relief. The administration of MP4CO as an adjunct treatment to standard therapy may~     alleviate pain associated with a sickling crisis and potentially reduce the severity and~     duration of a crisis. This may shorten the time in hospital and potentially improve the~     quality of life for patients with sickle cell anemia.~   "
86513|NCT01924988|"~     This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption~     protocol, with the primary goal of determining the safety of prostatic artery embolization~     (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of~     side effects, particularly bladder and rectal complications, which may occur as a result of~     this procedure. Secondarily, the study will provide preliminary data to determine its~     effectiveness in diminishing obstructive symptoms associated with BPH.~   "
86514|NCT01924975|"~     The purpose of this study is to compare the two different saphenous vein cannulation~     techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional~     landmark technique (Landmark group).~   "
86515|NCT01924962|"~     The study is a randomised comparison of recanalisation of chronic occluded coronary arteries~     with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and~     scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the~     superiority of medical therapy over revascularisation.~   "
86516|NCT01924949|"~     This study is to evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial~     genotype 1 hepatitis C virus (HCV) infection.~   "
86519|NCT01924910|"~     The purpose of this study is to determine if a single dose of vitamin D administered orally~     in the fall will provide adequate vitamin D in healthy individuals for the duration of the~     winter, during which vitamin D levels are known to decrease. The investigators are also~     interested in finding out if this level of vitamin D will provide adequate levels for the~     remainder of the year. While the benefits of once-yearly vitamin D administration are clear~     for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with~     vitamin D deficiency and high bone turn-over, studies have not been performed in which high~     doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in~     healthy individuals. These findings could provide evidence to support vitamin D~     administration to healthy individuals in the wintertime to improve health outcomes, and~     provide the basis for additional studies in both healthy and sick populations.~   "
86520|NCT01924897|"~     Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal~     surgery team at the Norfolk and Norwich University Hospital and the University of East~     Anglia to look at the role of exercise before surgery to improve recovery following an~     operation.~      Having an operation to remove part of the bowel puts physical stress on the body. We know~     that training can help the body cope with physical stress in the same way that an athlete~     trains before a competition. We hypothesise that the body may recover more quickly if it is~     trained prior to an operation with regular and simple exercises.~      Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart~     and muscles at rest and during exercise. CPET testing is often done as part of standard~     pre-operative assessment in many hospitals for patients before undergoing major surgery.~     Some studies have demonstrated that CPET can be used to predict outcomes following surgery~     (such as time taken till discharge, complication rates).~      The study consists of two parts:~      Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test~     to determine baseline fitness. Blood tests will be taken around the time of surgery to~     examine whether biochemical markers in the bloodstream (when used in combination with~     results from the CPET test) can predict outcomes and recovery following colorectal surgery.~     Patients will then be monitored to assess their speed of recovery and rate of complications~     following surgery.~      This will enable us to determine which CPET variables or combination of variables are most~     useful in the prediction of post-operative complications following colorectal surgery.~      2) The second study will consist of an exercise intervention involving several sessions of~     supervised exercise in a laboratory. Before and at the end the exercise training regime,~     CPET measurements will be taken to see if fitness has improved with exercise.~      This part of of the study is to determine if it is feasible to implement a structured,~     supervised exercise programme for patients awaiting elective colorectal cancer surgery. The~     results of this study will be used to inform a larger randomised controlled trial to examine~     the influence of exercise on CPET variables and postoperative outcomes.~   "
86521|NCT01924884|"~     The goal of this study is to present a large single-institution experience reporting~     surgical site infection rates in patients who have undergone intra-abdominal surgery~     followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of~     patients' charts will be conducted to analyze surgical site infection rates between wound~     closure with and without Negative Pressure Wound Therapy (NPWT). American College of~     Surgeons National Quality Improvement Program data from previous standard of care (primary~     closure after colorectal surgery) will be used for comparison with newly adopted standard of~     care treatment regimen (wound closure with NPWT).~      Data on patients who underwent intra-abdominal surgery will be retrospectively collected and~     a database will be created. These individuals will be identified through medical records and~     recontacted by mail and/or phone to collect study data.~      Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery~     will be enrolled in the database. After giving informed consent, data on surgical site~     infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30~     days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to~     a group of patients treated by the Principal Investigator who also underwent intra-abdominal~     surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated~     with negative pressure wound therapy following intra-abdominal surgery will develop surgical~     site infections than patients who had intra-abdominal surgery but were not treated with~     Negative Pressure Wound Therapy.~   "
86522|NCT01924871|"~     It has been reported that deep extubation can reduce cardiopulmonary complication against~     endotracheal tube extubation during emergence from general anesthesia. The investigators~     hypothesized that using desflurane with target controlled infusion of remifentanil is more~     effective than using desflurane alone during deep extubation. The purpose of this study is~     to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing)~     during emergence from general anesthesia.~   "
86523|NCT01924858|"~     This is an open label, PET study in healthy male subjects to determine if GSK2647544 is able~     to cross the blood-brain-barrier. The study will use GSK2647544 radiolabelled with~     fluorine-18 ([18F] GSK2647544) to determine the ratio of the concentration of the compound~     in tissue to that in plasma at equilibrium, expressed as the PET volume of distribution~     (VT). The study will consist of at least four visits; 2 screening visits, scanning day and~     follow-up. On Day 1 (scanning day) the subject will receive a single oral dose of GSK2647544~     (100 mg) followed approximately 2 hours later by a single intravenous (IV) infusion of~     [18F]-GSK2647544 and a dynamic PET scan. Arterial and venous blood sampling will be used to~     determine the plasma kinetics of [18F]-GSK2647544 and unlabeled GSK2647544. In addition,~     each subject will undergo a structural magnetic resonance imaging (MRI) scan of the brain to~     aid in the definition of neuroanatomy. The dose of GSK2647544 was selected based on the~     review of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) data~     obtained in the first time in human (FTIH) study.~   "
86524|NCT01924845|"~     Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset~     Pompe disease who have been receiving treatment with recombinant human acid~     alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to~     moderate respiratory impairment will switch directly to receive BMN 701 20 mg/kg by IV~     infusion every other week. All participants will receive active drug. No dose of existing~     therapy will be missed - experimental drug is started immediately.~   "
86525|NCT01924832|"~     The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of~     monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg~     (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy~     volunteers. The secondary objective of this study is to evaluate the safety and tolerability~     profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to~     varying regions within the GI tract in healthy volunteers.~   "
86541|NCT01924624|"~     Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical~     resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven~     effective in preventing or delaying recurrence. The aim of this prospective randomized study~     was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in~     inhibiting the recurrence of HCC~   "
86526|NCT01924819|"~     Gastric cancer remains a significant global public health problem. Although in developed~     countries its incidence has dramatically decreased, on a worldwide scale it is still a~     leading cause of cancer-related deaths. Surgery is the only potentially curative treatment~     for gastric cancer. Although the survival rates for patients with early stage disease (stage~     1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing~     resection. The majority of patients will have locally advanced or metastatic disease at~     presentation, which has an extremely poor prognosis. The current five-year survival rate for~     gastric cancer in Western countries is approximately 20-30%, a figure that has improved~     little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative~     chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The~     control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy.~     The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy~     to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving~     pathological complete response rates in the first instance, and subsequently overall~     survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric~     cancer.~   "
86527|NCT01924806|"~     A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention~   "
86528|NCT01924793|"~     This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with~     parainfluenza infection.~      All subjects will have additional PK and Immunogenicity blood samples collected.~   "
86529|NCT01924780|"~     This will be a two-stage study to test whether t-VNS using the NEMOS device can activate the~     CAP and reduce markers of systemic inflammation. Stage A (healthy volunteers) stage B~     (patients with Juvenile Idiopathic Arthritis).~      Stage A: healthy human volunteers. A randomized, single blind, three-period crossover design~     comparing the CAP activation effect of 10 minutes (active) versus 60 minutes (active) versus~     10 minutes (sham) stimulation with the NEMOS device. CAP activation will be assessed by~     reduction in the in vitro release of LPS-inducible cytokines from whole blood.~      Analysis of the reduction in whole blood cytokine release assay after 10 versus 60 minutes~     of stimulation, and the kinetics of the nadir of the whole blood cytokine release assay will~     inform the selection of dose duration and sampling time for Stage B. Performing this more~     extensive exploration of dose duration and kinetics in adults will allow one dose, and a~     single optimal sampling time in the JIA patients, thus minimizing blood drawing and~     discomfort in these children.~      Stage B will be performed in patients with JIA. This will be an open label design examining~     the effect of the optimal dose duration (either 10 minutes or 60 minutes of stimulation, as~     determined by results of Stage A). All information regarding Stage B will be registered in a~     separate registration at clincialtrials.gov. in order to keep accuracy. All details below~     concerns only Stage A.~   "
86530|NCT01924767|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with~     repeat dosing for eight days and the exploration of the pharmacokinetics and~     pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and~     assessment of steady state.~   "
86531|NCT01924754|"~     In collaboration with the Thai Red Cross AIDS Research Centre, the investigators are~     performing a study of 2 new HPV vaccine delivery regimens in healthy young Thai women. The~     study will be performed in Bangkok. The investigators will be testing the serum from these~     women at UCSF for HPV antibodies to measure the strength of their response to the vaccine.~   "
86532|NCT01924741|"~     Recently a new method of induce similar hypertrophy in the liver as is observed after~     hepatectomy has been described and was given the eponym ALLPS. ALPPS stands for~     Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS).~      Since the procedure is used worldwide this international registry was created to enable~     tracking of cases performed worldwide for safety and outcomes and innovations by the groups~     involved as well as allows a non-randomized comparison to the conventional methods of portal~     vein occlusion.~   "
86533|NCT01924728|"~     The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female~     patients with stress urinary incontinence.~      Based on the available data on magnetic stimulation, the investigators hypothesize that~     magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary~     leakage upon exertion as well as improve patients' quality of life.~   "
86534|NCT01924715|"~     Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic~     Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction~     is greater than that of a control group and whether any such gains would be maintained in~     follow up.~      Design: A quasi-experimental design was employed in which pre and post healthcare cost and~     usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to~     parallel measures of a control group of cases referred but never treated.~   "
86535|NCT01924702|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     enhance the outcome of intensive language therapy in chronic aphasia.~   "
86536|NCT01924689|"~     This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT~     spores in patients with treatment-refractory solid tumor malignancies. This investigational~     study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients~     with treatment-refractory solid tumor malignancies.~   "
86537|NCT01924676|"~     To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg~     doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to~     PF-00345439 Formulation X in the fasted state in healthy volunteers~   "
86538|NCT01924663|"~     The purpose of this study is to be able to better describe the incidence, timing and~     severity of myocardial dysfunction and acute kidney injury (AKI) following a documented~     respiratory viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.)~     in pediatric patients.~   "
86539|NCT01924650|"~     The purpose of this study is to investigate the effects of varying particle size on the~     pharmacokinetics of PH-797804~   "
86540|NCT01924637|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect~     of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in~     subjects with type 1 diabetes.~   "
86542|NCT01924611|"~     AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate~     of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both~     genders, were selected having one primary molar with a proximal dentine lesion. The children~     were randomly divided into two groups: a control group with class II ART restoration made~     using cotton rolls and an experimental group using rubber dam. The restorations were made~     and they were followed up every six months. After two years, the results were compilated and~     analyzed.~   "
86543|NCT01924598|"~     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of~     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and~     healthcare costs. Exploration of underlying processes and novel treatment strategies is thus~     crucial. This is a pilot study of a novel translational approach to the investigation and~     treatment of severe AN. The aims are (1) to explore the safety, acceptability and~     feasibility of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning~     aberrant reward and optimise DBS targets. The study will involve 6 consenting adults with~     full mental capacity, and will last 15 months. It incorporates an ethical substudy including~     assessment of capacity and informed consent. It combines complementary forms of cutting edge~     neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in~     helping identify the best strategy for treating severe AN using DBS. Individuals with severe~     intractable AN will be eligible to take part. The study will be conducted in Oxford, United~     Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have~     preoperative ethical, neuroimaging and psychological assessments, A DBS operation in month~     2, DBS switch on in month 3 month postoperatively . DBS will be targeted to the Nucleus~     accumbens, followed by a 12 month post switch on follow-up period with monthly joint~     neurosurgical psychiatric and psychological assessments and postoperative MEG scans . The~     study will further our understanding of food reward processes in general and AN in~     particular indeed promises to provide important information which may revolutionize future~     treatments. The proposal builds upon a body of research investigating the role of aberrant~     reward processes in AN and exploits our complementary research experience in AN using~     experimental behavioural strategies, fMRI , MEG and DBS to establish a powerful~     translational research strategy.~   "
86544|NCT01924585|"~     Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years~     and older undergoing major colorectal surgery. That is to say we are looking at how older~     patients recovery following surgery, and that patients who volunteer to take part will~     absolutely not have any changes made to patients planned treatment or surgery.~      Patients (identified by their Consultant) will be asked if they would like to participate in~     the study, agreeing to undertake an additional questionnaire, blood test, provide a urine~     specimen and several basic physical tests during the pre-assessment visit taking an~     additional 30-45 minutes.~      This will not affect their treatment in any way. Participation is voluntary.~      At the time of the pre-assessment process the patient will then be approached by a~     researcher, who will explain the study in more detail and obtain written consent.~      The questionnaire is a combination of questions, which have been used in other similar~     studies and may be used to identify people who are fitter than others to undergo surgery.~     These questions are not too dissimilar to those that may be asked during the pre-assessment~     process. In fact some hospitals use some of these questions (but not usually all) routinely~     during a hospital admission process.~      Several basic physical tests will be performed: hand grip strength test and some basic~     walking and chair rising tests. These will be supervised by the trained researcher to ensure~     they are carried out safely.~      A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for~     the standard pre-operative assessment process. We will also take urine specimens. The blood~     sample and urine specimens will be saved for tests later. There are several potential blood~     and urine tests that may be related to physical frailty/impairment and the aging process.~      The patient will undergo surgery as planned and be discharged from hospital. No researcher~     will interfere with the planned care or conduct any data collection at this point.~      At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to~     complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at~     the time of their postoperative follow-up checks, then we will repeat the basic physical~     tests again also.~      The patient's notes will be reviewed by a researcher (who is also a doctor) to see what~     operation was performed, the length of hospital stay, and if any problems developed. The~     patients GP may also be contacted if additional information is required.~      This study, while based on several others, is the first of its kind to see how persons~     recover after surgery being assessed over one year.~      We will recruit for 18 months across two hospitals aiming to recruit 200 patients during~     this time.~   "
86545|NCT01924572|"~     The proposed study is a pilot prospective controlled trial to measure the blood volume left~     in the placenta after varying cord clamping times when the infant is placed skin-to-skin on~     the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants.~     However, the best way to get the most blood to the baby is not known. The practice of cord~     clamping at birth is not the same among doctors and midwives and we do not know the effect~     of putting he baby on the mother's abdomen.~   "
86546|NCT01924559|"~     We will investigate the impact biohazard gear has on time to successful intubation and, in~     particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus,~     Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video)~     intubation techniques.~   "
86547|NCT01924546|"~     There is a large body of evidence from adult populations suggesting cognition in adults is~     affected by hydration status. The few studies conducted in the global North in populations~     of schoolchildren indicate that drinking water has an impact on pupil performance on basic~     cognitive tasks. No studies assessing the impact of dehydration and cognition in~     schoolchildren have been published in the global South, where access to water is the poorest~     and dehydration prevalence is likely higher. Our group previously carried out research on~     this topic in Mali, and will build upon findings from that work with this trial. This study~     will examine the effect of drinking supplementary water during the school day on hydration~     status and on cognitive test scores in schoolchildren in Zambia.~      The investigators hypothesize that providing supplemental water will result in a decrease in~     prevalence of dehydration in the study group and will result in an improved performance on~     cognitive test scores.~      Data will be collected from up to four purposively-selected schools in the region of Zambia~     where this study is taking place, from up to a total of 400 children. At each school pupils~     in grades 3-6 will be eligible for recruitment, dependent upon their understanding of~     research instructions. Research staff will explain the study to pupils at the school and~     individually request informed oral assent for participation. A waiver of parental consent~     for pupil interviews will be secured from the Ministry of Education. At each school, school~     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the~     pupil participants.~      Children that assent to participate in the study will be randomly allocated to the~     intervention or control group. In the intervention group, study participants will receive~     supplementary water in the morning. In the control group, study participants will receive~     supplementary water in the afternoon. Testing procedures in both groups is identical and~     will include a five-minute interview, two cognitive testing sessions of 45 minutes each, and~     collection of two urine samples during the day. None of these activities collect personal~     data or identifiers, and the urine sample will not be stored.~      All data collection will occur at the school and will be conducted by trained local~     enumerators. There are no risks to participation other than a small amount of class time~     missed by pupils, and great efforts will be made to minimize time outside of class.~   "
86548|NCT01924533|"~     This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,~     compared with placebo in combination with paclitaxel in patients with advanced gastric~     cancer who have progressed following first-line therapy. Patients will be from China, Japan~     , Korea and Taiwan.~   "
86549|NCT01924520|"~     A study was to evaluate the safety and plasma concentration changes of quetiapine after~     repeated administration of FK949E (extended-release formulation of quetiapine) in patients~     with major depressive disorder (MDD).~   "
86550|NCT01924507|"~     The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology~     intensive care unit. The patients will be submitted to a overnight polysomnography. Those~     individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the~     investigators will identify the factors that compromise the sleep and will act to minimize~     them to improve the sleep quality.~      After the interventions, the investigators will evaluate if there are reduced days of~     hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and~     stroke) and overall mortality.~   "
86551|NCT01924494|"~     Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy~     by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital~     based endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the~     possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line~     or through new established transmission lines, will be evaluated. The EndoAlpha system will~     be integrated in a highly advanced endoscopy procedure room. The system will integrate~     through LAN with doctor office, clinic conference and lecture room and GI pathologist room.~     Through either LAN or WAN, connection will be establish to a referral GI center in Denmark.~     Through WAN, connection will be established to doctor home and to an expert Spanish center.~   "
86552|NCT01924481|"~     The Hershey Company is interested in investigating the effects of various chocolate~     beverages on brain physiology and cognitive function. The main substances in the drinks that~     are known to influence the brain are caffeine (and related chemicals such as theobromine)~     and flavonoids. Flavonoids are chemical found in plants and are most commonly associated~     with antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all~     naturally occurring and all potentially alter brain physiology. This study will evaluate~     changes in brain blood flow and cognition following the consumption of drinks with various~     combinations of the Primary Ingredients. Caffeine is likely to have peak effects within~     1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4~     hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm~     cross-over double-blind design in an attempt to understand the differential effects of these~     compounds in chocolate drinks.~   "
86553|NCT01924468|"~     Background:~      - The risk for becoming addicted to drugs varies from person to person, even among those~     using similar drugs in a similar way. Researchers do not fully understand why some people~     become addicted to drugs and others do not. Studies suggest that under certain life~     circumstances, some genes may increase the risk for addiction. This study will use genetic~     information, computer tasks, magnetic resonance imaging (MRI), and other tests to see what~     brain networks may be related to drug addiction.~      Objectives:~      - To better understand brain networks that may be related to susceptibility to drug~     addiction.~      Eligibility:~      - Healthy non-smoking volunteers between 18 and 55 years of age.~      Design:~        -  This study will have one screening visit and four all-day study visits. For male~          participants, the visits will be about 7 days apart over 5 to 7 weeks. Female~          participants will have the visits scheduled to coordinate with their menstrual cycle.~        -  This study involves small doses of three approved drugs: two oral dopamine drugs and a~          nicotine patch. For each scanning session, participants will have three study drugs.~          However, only one pill or patch will be the real drug; the other two will be placebos.~          Some participants may have only placebos during a visit.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be taken. Other tests will be given to ensure that participants are not~          smoking or using drugs while they are in the study.~        -  During the all-day scanning visits, participants will receive two pills and one patch~          in the morning and they will be trained on simple computer tasks. In the afternoon,~          participants will have MRI scans and we will measure their brain activity while they~          rest and while they perform computer tasks in the scanner. Participants will also~          answer questionnaires during the scanning visits.~   "
86554|NCT01924455|"~     Despite effective ART that can suppress both HIV and HBV, HBV-related liver disease remains~     a significant co-morbidity in this population. Little is known about the histologic spectrum~     of liver disease, the significance of complete vs. incomplete HBV suppression, the utility~     of novel virologic and serum markers of disease severity, and the long-term renal and bone~     effects of TDF-based therapy. This proposal will address these important questions and~     impact the science and health of those coinfected with HBV-HIV.~   "
86555|NCT01924442|"~     The Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) Trial (CSP #517) was~     funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term~     (1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass~     graft (CABG) procedures. The ROOBY trial reported a significantly higher 1-year adverse~     composite outcome rate (i.e., all-cause death, non-fatal myocardial infarction (MI) and/or~     repeat revascularization) for off-pump versus on-pump patients. ROOBY documented that a~     higher percentage of off-pump patients received fewer grafts than originally planned (i.e.,~     off-pump patients were less completely revascularized) as compared to on-pump patients.~     Across all anatomic regions of the heart, the 1-year graft patency rates were significantly~     lower for off-pump CABG patients. Based on these ROOBY trial initial findings, critically~     important clinical questions related to the long-term efficacy, stability and durability of~     the off-pump versus on-pump techniques have been raised. Extending the original ROOBY trial,~     this CSP #517 follow-up study (CSP 517-FS) will evaluate the longer-term impact of off-pump~     versus on-pump surgical approaches upon the future occurrence of major adverse~     cardiovascular events (MACE).~   "
86556|NCT01924429|"~     The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication~     used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity~     in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for~     participation in this study because they have ADHD and are willing to participate in two~     Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of~     their symptoms. Another purpose of this study is to collect and bank samples of blood for~     research to examine how genes influence brain activation seen during the brain scans. The~     study also seeks to find out whether certain genes are related to ADHD. Participants' entire~     genetic makeup will not be determined from this sample.~   "
86557|NCT01924416|"~     The primary specific aim is to test the hypothesis that use of a decision aid to enhance~     informed, shared decision making coupled with quality of life assessment in patients with~     advanced lung cancer receiving first-, second-, or third-line therapy will lead to a~     reduction in two major contributors of cost (number of chemotherapy cycles; number of~     advanced imaging studies) compared with the control arm.~   "
86558|NCT01924403|"~     This study will assess which of the three most common methods of wound closure in primary~     total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular~     suture) provide the best wound vascular perfusion. This can be achieve by using SPY~     intra-operative vascular angiography, which is commonly used in clinical practice to assess~     perfusion of wound closure at the clinic. By understanding the differences in perfusion~     afforded by different closure techniques, surgeons will then be able to select the technique~     that optimizes this parameter so as to avoid complications such as tissue necrosis, wound~     dehiscence, or infection.~   "
86576|NCT01924169|"~     The goal of this clinical research study is to learn if lenalidomide can increase the level~     of immunoglobulins (parts of the blood that may help to improve the immune system's~     function) and/or will improve the protective effect of the flu and pneumonia vaccines in~     patients with CLL.~   "
86559|NCT01924390|"~     This entire protocol involves procedures that are standard care. The purpose of the research~     is to evaluate whether there are any differences in new bone formation following tooth~     extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or~     a combination of 70% mineralized & 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are~     commonly used in dentistry for this purpose. Until recently, there has been no human~     evidence of differences in new bone formation with one material versus another. Recently,~     DFDBA has been shown to provide a greater percentage of vital bone formation than FDBA. No~     studies have been done on materials that provide a combination of demineralized and~     mineralized FDBA for ridge preservation. That is the purpose of this study.~      There will be two subject groups in this study. All subjects will require extraction of at~     least one non-molar tooth, followed by replacement of the missing teeth with dental~     implants. Each group will have 22 subjects. The primary distinction between groups will be~     the use of either a combination of 70% mineralized & 30% demineralized FDBA or 100%~     mineralized FDBA: Group 1 will have 70% mineralized & 30% demineralized FDBA grafted into~     the extraction socket for ridge preservation. Group 2 will have 100% mineralized FDBA~     grafted into the extraction socket for ridge preservation. The allocation of subjects into~     group 1 or 2 will based on numbers drawn from a stack of sealed envelopes. A small flap will~     be reflected to an extent about 3-4mm beyond the bony walls of the socket. A measuring stent~     will be placed and measurements of ridge width and ridge height will be taken and recorded~     to the nearest 0.5mm. Ridge width will be measured using a ridge caliper at a point~     approximately 4mm apical to the facial and lingual bony crest. Ridge height will also be~     measured. The tooth will be extracted and the subject will then be randomized by drawing a~     sealed envelope from the stack. Either 100% mineralized FDBA or a combination of 70%~     mineralized & 30% demineralized FDBA will be placed in the socket to restore the ridge to~     appropriate contour. A dense polytetrafluoroethylene (PTFE) membrane will then be placed~     over the socket orifice extending about 3mm beyond the bony socket walls. A PTFE suture will~     be placed over the membrane to secure it in place. Primary closure will not be attempted.~     The patient will be seen 7-10 days after extraction/ridge preservation to assess healing.~     The subject will be seen again 21-28 days to remove the PTFE membrane and to assess clinical~     healing.~      At the time of implant placement, the measuring stent and caliper will be used to determine~     the ridge width and ridge height again. The implant site will be prepared using a hollow~     trephine which allows retention of the bony core. The bone removed from the osteotomy site~     remaining in the trephine will be prepared for histologic examination and analyzed for new~     bone growth. The following histologic parameters will be measured: percent vital bone~     formation; percent residual graft material; and, percent nonmineralized connective~     tissue/bone marrow. Following initial preparation of the implant site with the trephine, an~     implant of the appropriate length and diameter will be placed. A healing abutment will then~     be placed. All subjects will be examined at 7-10 days following implant placement. The study~     will end at the time of this follow up visit. The patient will then be referred to his/her~     restorative dentist for final restoration.~   "
86560|NCT01924377|"~     Recent clinical studies have shown that atrial fibrillation (AF) in humans might be~     sustained by localized sources called mother rotors which exhibit persistent, fast, and~     well organized activity during AF and play an important role in the generation and~     maintenance of the fibrillatory activity. In this study, investigators aim to identify the~     electrophysiological characteristics of mother rotors during atrial fibrillation in patients~     with paroxysmal and persistent AF and to test whether ablation of such patient-specific~     substrates might improve the acute and long-term success of conventional catheter ablation~     therapy.~   "
86561|NCT01924364|"~     The overall purpose of this research is to evaluate the physical changes that occur over~     time after fat grafting for craniofacial trauma. This protocol is similar to an existing~     study (IRB# PRO0906101) presently conducted at the University of Pittsburgh by the same~     research team which utilizes fat grafts. The preparation of the fat graft material in each~     clinical trial is processed differently evaluating the effects of graft resorption after~     treatment.~   "
86562|NCT01924351|"~     Primary Objective:~      To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a~     6-month distant brain relapse rate of less than 30%.~      Secondary Objectives:~        1. Describe the natural history of neurocognitive function for women with brain metastases~          treated with SRS and HER-2 directed systemic therapy and establish a reference~          benchmark to generate hypothesis for future design of a phase III trial.~        2. Describe patterns of distant brain relapse after SRS for all patients and compare them~          between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients~          treated with each systemic therapy regimen~        3. Describe patterns of neurologic death~        4. Describe patterns of local brain relapse~        5. Describe patterns of re-irradiation with WBRT or SRS~        6. Describe adverse events~   "
86563|NCT01924338|"~     The study is intended to verify a newly developed method to measure the thickness of cranial~     soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser~     scan of the forehead. The laser scan is acquired point by point with a prototype scanning~     unit developed at the University of Luebeck's Institute for Robotics.~      The measured tissue thickness using the near-infrared scanning approach is validated against~     the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method~     is then computed over all subjects from the individual study arms.~      The required laser intensity and exposure time as well as the achieved measurement accuracy~     is evaluated with respect to the different skin types of the test subjects. Correlation~     between these features and the skin type according to the Fitzpatrick scale will be~     computed.~      For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The~     results of the scans are compared and time dependency is analysed.~   "
86564|NCT01924325|"~     Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease~     with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin~     treatment reduced the risk of recurrent stroke and was not associated with increased~     hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is~     proved to be as effective as traditional anticoagulants with less risk of bleeding events.~      To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized,~     double-blind, multicenter, controlled clinical trial has been designed. The investigators~     will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and~     aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling~     cerebrovascular event.~   "
86565|NCT01924312|"~     Vascular risk factors may account for up to 80% of the memory and thinking problems~     experienced by our aging population today, by far in excess of that caused by Alzheimer's~     disease. By doing this study, we hope to learn how vascular risk factors cause memory and~     thinking changes in the elderly, and whether we can prevent memory and thinking changes by~     reducing these risk factors. Successful completion of project aims will allow an integrated~     understanding of mild cognitive impairment caused by vascular risks (MCI-CVD) with the~     potential for tremendous impact on one of the major healthcare crises facing the nation~     today.~      The study will enroll 80 participants with memory and thinking problems (mild cognitive~     impairment; MCI) and are at risk for stroke and further difficulties with memory and~     thinking that may eventually lead to disability and a diagnosis of dementia. Each~     participant will be randomized into one of two groups (40 in each group) and followed over~     36 months. One group will be followed to allow us to understand the natural history of~     memory and thinking impairment, while the other group will receive intensive education and~     assistance with vascular risk factor (CVD) control.~   "
86591|NCT01923974|"~     A study investigating the analgesic effect of melatonin in a human heat injury model using~     quantitative sensory testing.~   "
86566|NCT01924299|"~     The main purpose of this study is to look at the effect of ketoconazole and fluconazole on~     how much baricitinib gets into the blood stream. The study will also look at the~     tolerability of baricitinib and ketoconazole when given together and the tolerability of~     baricitinib and fluconazole when given together.~      Participants will be recruited into one of 2 treatment groups (Group A, Group B). Each~     treatment group will participate in 2 study periods. Participants will take baricitinib~     alone in one period and baricitinib with either ketaconazole or fluconazole in the other~     period. This study will last approximately 7 weeks.~   "
86567|NCT01924286|"~     Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients~     starting antiretroviral therapy (ART) in developing countries and thus the most frequent~     form of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8-~     43% of patients starting ART while on TB treatment and results in morbidity,~     hospitalisation, consumes health care resources and TB-IRIS may be fatal. We have previously~     demonstrated in a clinical trial that prednisone reduces morbidity when used for treatment~     of paradoxical TB-IRIS. This trial is a double-blind placebo-controlled trial of~     prophylactic prednisone (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on~     the same day as ART) in patients with TB who are identified as being at high risk for~     paradoxical TB-IRIS (starting ART within 30 days of initiating TB treatment and CD4 <~     100/μL). The trial will enroll 240 participants, randomised 1:1 (prednisone:placebo). The~     primary endpoint is development of paradoxical TB-IRIS, defined using international~     consensus case definitions. Secondary endpoints include time to IRIS event, severity of~     IRIS, quality of life assessment, mortality and corticosteroids adverse events. The trial is~     powered to determine a reduction in TB-IRIS events.~   "
86568|NCT01924273|"~     Port wine stains Birthmark are congenital, progressive vascular malformations of the skin~     that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the~     United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds~     of these malformations occur on the face. Personality development of virtually all patients~     is adversely affected as a result of the negative reaction of others to a marked person.~     Detailed studies have documented lower self-esteem and difficulties with interpersonal~     interactions in Port wine stains patients. Port wine stains are initially flat and red, but~     with time, they tend to darken to purple and become thickened as vascular nodules develop.~     This thickening occurs in approximately two-thirds of lesions and further disfigures the~     facial features of many patients.~   "
86569|NCT01924260|"~     This phase I trial studies the side effects and the best dose of alisertib when given~     together with gemcitabine hydrochloride in treating patients with solid tumors or pancreatic~     cancer that is metastatic or cannot be removed by surgery. Alisertib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     alisertib with gemcitabine hydrochloride may be an effective treatment for solid tumors or~     pancreatic cancer.~   "
86570|NCT01924247|"~     Background:~      Stroke represents one of the major health problems worldwide, particularly in transitional~     and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in~     the ageing population, and therefore stroke prevention is important. Secondary preventive~     measures and rehabilitation are essential for reduction of recurrent events. However, to~     date appropriate secondary preventive programs for patients surviving a stroke with minor or~     no residual deficits have been poorly studied.~      Specific aims/projects:~      The aim of this study is to validate the effects of an outpatient secondary prevention~     program on vascular risk factors, adherence to vascular-protective medication, exercise~     capacity and health related quality of life.~      Working Hypothesis:~      The outpatient rehabilitation program results in a significant short (3 months) and~     long-term (1 year) improvement of vascular risk factors, neurological functions, exercise~     capacity, adherence to vasoprotective medication and health related quality of life.~      Experimental design/Methods:~      This is a prospective, randomized clinical trial. At least 100 patients will be randomized~     either to a group that starts the rehabilitation program immediately after the stroke or~     with a delay of 3 months. All patients will be assessed at baseline, at 3 months and 1 year.~     The primary outcome is the number of reached cardiovascular health goals (6 metrics) between~     the immediate and the delayed program start group at 3 months.~      Expected value of the proposed project:~      The study has the potential to show that an outpatient rehabilitation program significantly~     improves vascular risk factors, adherence to medication, enhances quality of life and~     eventually reduces recurrent strokes and other vascular events. If this is confirmed,~     introducing outpatient rehabilitation programs will have a major socioeconomic impact.~   "
86571|NCT01924234|"~     The purpose of the study is to determine whether remifentanil influence the pharyngeal phase~     of swallowing using using pressure and impedance recordings. The purpose is also to compare~     remifentanil to morphine and younger to elderly volunteers.~   "
86572|NCT01924221|"~     Cardiac resynchronization therapy with pacemaker alone, or in combination with a~     cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation~     in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS~     duration 6 months after cardiac resynchronization therapy. Such fenomenon is called reverse~     electrical remodeling of native conduction. Retrospective analysis showed that reverse~     electrical remodeling of the native conduction after at least 6 months of CRT is associated~     with decreased rate of ventricular arrhythmias and better survival. This study is designed~     to study reverse electrical remodeling prospectively.~   "
86573|NCT01924208|"~     Hypotheses~        1. Immunotherapy induces tolerogenic effects to allergens in T cell regulation in tonsils.~        2. Influenza vaccination induces a strong interferon response and decreases Th2 response~          in tonsils.~        3. Influenza vaccination as an adjuvant on immunotherapy induces a better response to~          immunotherapy.~   "
86574|NCT01924195|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of~     andvanced non-small cell lung cancer who failed two lines of chemotherapy~   "
86575|NCT01924182|"~     This study compares two different ways to treat pain. The two ways are:~        1. continuing to take current pain medication(s) or~        2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to~          your body) that is implanted.~      None of the procedures or products used in this study are experimental. The length the study~     will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare~     pain and opioid side effects between people who get a drug pump and people who do not get a~     drug pump that will stay on their current pain medication treatment.~   "
86577|NCT01924156|"~     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells~     (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell~     carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express~     MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our~     previously performed preclinical study with DC vaccine combined with CIK cells, the~     investigators plan to perform the clinical trial.~   "
86578|NCT01924143|"~     The purpose of the study is to evaluate the absorption, distribution, metabolism, and~     excretion (ADME) of a single oral dose of [14C]TD-9855~   "
86579|NCT01924130|"~     The purpose of this study is to develop and evaluate the effects of a school breakfast~     policy initiative (SBPI) on the incidence of overweight and obesity as well as breakfast~     patterns (both inside and outside of school) among 4th-6th grade children. The study~     integrates research, education and extension to promote healthy breakfast consumption among~     low-income children in urban schools and will leverage ongoing SNAP-Ed and the School~     Breakfast Program efforts.~   "
86580|NCT01924117|"~     Objective: Determine the genotypes and risk factors associated with human papilloma virus~     infection in Mexican women.~      Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital~     Mónica Pretelini and the Medical Research Center (CICMED), who were asked to complete a~     risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples~     were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).~   "
86581|NCT01924104|"~     The purpose of the study is to determine whether low-dose aspirin and low molecular weight~     heparin improve the implantation and pregnancy rates in patients with repeated implantation~     failures in IVF cycle.~   "
86582|NCT01924091|"~     To compare drug concentrations in vaginal fluid, genital tissue, and blood~   "
86583|NCT01924078|"~     The present study is to determine the adverse effects and clinical efficacy of AI combined~     with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with~     Estrogen receptor and/or Progestrogen receptor positive.~   "
86584|NCT01924065|"~     Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo~     transesophageal echocardiography or they will receive warfarin for 3 weeks with an~     international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use~     warfarin will be given an approved new oral anticoagulant agent istead of warfarin for 3~     weeks.~      If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be~     performed. Other patients in the both groups will undergo electrical cardioversion. After~     the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All~     patients will have neurological examination and diffusion magnetic resonance imaging (MRI)~     at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic~     events detected by diffusion MRI will be recorded. Any bleeding events during this period~     will also be recorded.~   "
86585|NCT01924052|"~     The investigators hypothesized that migraine without patients with many genetic loci~     associated with migraine (high genetic load) would be more sensitive and get provoked more~     migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few~     genetic loci associated with migraine (low genetic load).~   "
86586|NCT01924039|"~     The investigators are proposing a project that will examine the effectiveness of brief~     motivational enhancement therapy in a population with concurrent psychotic disorders and~     substance use disorders. This study will represent an emerging line of inquiry, as best~     practice interventions with this concurrent disordered (CD) populations are yet to be~     established.~   "
86587|NCT01924026|"~     Phenylketonuria (PKU) is a genetic disorder known to cause severe reduction in intelligence~     and deficits in cognitive function; it is associated with an elevated level of Phenylalanine~     (Phe) in blood.~      Newborn screening and early treatment with restricted protein diet supplemented by a formula~     of amino-acids will preserve intelligence. In those with the severe form treated from birth,~     some deficits that affect higher functions of the brain are seen.~      Given this, there is disagreement about how milder forms of this disease should be managed~     and what level of Phe is safe to be left untreated.~      We seek to assess whether higher Phe levels, between 360 and 600µmol/L, are safe with~     respect to preservation of intelligence and higher cognitive functions.~   "
86588|NCT01924013|"~     The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3~     supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases~     or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum~     vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at~     1 year of age among infants born to women who received vitamin D 28,000 U/week during~     pregnancy. Infants enrolled in the study will be followed for 2 years to document the~     persistence of any observed effects measured at 1 year of age. This study aims to enroll~     1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will~     be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000~     IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be~     additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months~     postpartum. In addition to linear length, the trial will include analyses of inflammatory~     and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D~     metabolism, and diarrheal and respiratory morbidity in the infants.~   "
86589|NCT01924000|"~     The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in~     enhancement of eyebrows.~   "
86590|NCT01923987|"~     Radical treatment of primary rectal cancer with synchronous distant metastases includes~     surgical resection of primary and metastatic lesion. However, primary rectal cancer in case~     of metastasized disease are often locally advanced disease and need downsizing before~     surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside~     liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and~     chemotherapy is used. However, the sequence of treatment modalities is not yet definitely~     established and preoperative chemoradiotherapy and surgical resection is accepted as an~     option of treatment. Conventional long course chemoradiotherapy delays administration of~     full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In~     present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by~     full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.~   "
86592|NCT01923961|"~     An increase of the free fraction may allow a better removal of of protein-bound uremic~     toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl)~     concentration will be increased in the infusion fluid at a target NaCl concentration and the~     effect on the removal of protein-bound toxins will be determined. Comparisons will be made~     to standard hemodialysis and hemodiafiltration.~   "
86593|NCT01923948|"~     Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing~     partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic.~     Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by~     the visual analogue scale (VAS) score.~   "
86594|NCT01923935|"~     The purpose of this study is to determine whether intravenous busulfan and melphalan as a~     conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous~     stem cell transplantation.~   "
86595|NCT01923922|"~     High grade cerebral glioma is the most common primary brain tumor in adults and accounts for~     about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year~     in Canada. Noninvasive accurate and timely diagnosis is imperative.~      High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective~     of any treatment. The prognosis of these patients can only be decided based on pathology~     after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance~     imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas.~     Computed tomography(CT) perfusion allows us to study the blood supply to the tumor at the~     level of capillaries. This information permits determination of aggressiveness of cerebral~     gliomas at the time of diagnosis.~      In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that~     CT perfusion can predict survival at the time of diagnosis irrespective of the pathological~     grade and the treatment received. In the present study, we would like to extend our~     preliminary findings in larger group of patients to ensure that this technique is indeed~     robust. If our hypothesis was supported by our study, we will be able to subselect patients~     based on initial imaging for more aggressive treatment. In patients with shorter survival,~     the perfusion parameters may help in identifying new therapeutic targets (e.g.,~     anti-angiogenic agents) that may help in the treatment of these patients.~   "
86596|NCT01923909|"~     Aim: To study and compare the clinical effects of platelet-rich plasma (PRP) injections and~     intra-articular (IA) corticosteroid injections in patients with primary osteoarthritis (OA)~     of the knee. This study aims to demonstrate this by using the Oxford Knee Score and Western~     Ontario and McMaster Universities Arthritis Index (WOMAC) to illustrate quantifiable~     difference between the two treatment modalities. Patient satisfaction will be compared by~     utilizing the Short-Form Survey-12 (SF-12) Score. Our null hypothesis states that~     intra-articular PRP injections is more beneficial in the long-term treatment of primary OA~     of the knee.~   "
86597|NCT01923896|"~     The proposed study represents the first attempt to systematically investigate the use of DCS~     as an adjunct to behavioral intervention to address chronic food aversion through an~     randomized control drug trial in children treated at the Marcus Autism Center's Pediatrics~     Feeding Disorders Program. This pilot and feasibility study will involve a total of 16~     participants randomly assigned to experimental conditions: behavioral intervention or~     behavioral intervention + DCS (8 in each group). All participants will receive the same~     behavioral protocol involving three treatment sessions per day (45 minutes in length), for a~     total of 15 sessions across five consecutive days. In addition, participants in the~     behavioral intervention + DCS group will receive a low dose (0.7 mg/kg) of the drug using an~     acute dosing methodology, which has been demonstrated to produce a nearly negligible side~     effect profile with comparable treatment outcomes to chronic dosing. Timing of dosing will~     occur 1 hour prior to behavioral intervention, in line with prior clinical studies. Study~     staff, with consultation from a psychiatrist, will observe administration of DCS to~     participants by caregivers via their preferred method of formula consumption (bottle, cup,~     or tube) in liquid form. Participants will be evaluated during each treatment session and at~     follow-up using trained observers to collect data on mealtime behaviors, including~     acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data~     collection is standard practice in the feeding disorders program. It is hypothesized that~     participants who receive DCS as an adjunct to behavioral intervention will show greater~     improvement in mealtime behaviors as reflected by these measures.~   "
86598|NCT01923883|"~     EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing~     pancreatic and peripancreatic solid masses. The aim of this study is to compare the two~     aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling~     with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of~     the specimens obtained by EUS-FNA with two aspiration methods.~   "
86599|NCT01923870|"~     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal~          in overweight male subjects with hepatic impairment and in volunteers with normal~          hepatic function.~        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male~          subjects with hepatic impairment and in volunteers with normal hepatic function.~   "
86600|NCT01923857|"~     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal~          in overweight male subjects with various stages of renal impairment and in volunteers~          with normal renal function.~        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male~          subjects with various stages of renal impairment and in volunteers with normal renal~          function.~   "
86601|NCT01923844|"~     Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral~     perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in~     premature infants, which is also associated with inflammation. There are different types and~     doses of surfactant preparations available. With the help of new generation monitors,~     changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be~     demonstrated.~   "
86602|NCT01923831|"~     The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on~     postoperative sore throat after spinal surgery in prone position with tracheal intubation.~   "
86626|NCT01923506|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic~     body radiation therapy may be able to send x-rays directly to the tumor and cause less~     damage to normal tissue.~   "
86603|NCT01923818|"~     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent~     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and~     slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral~     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying~     significantly less risk of intracranial hemorrhage.~      The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in~     China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is~     superior to aspirin alone for the treatment of high-risk patients with acute nondisabling~     cerebrovascular event.~   "
86604|NCT01923805|"~     This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood~     loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the~     patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to~     the current standard of care will also be evaluated. The effectiveness of VG to potentially~     reduce pain, and increase return to function and quality of life will be assessed through~     the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical~     Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded~     post-operatively.~   "
86605|NCT01923792|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is~     associated with poorer lung function, greater medication requirements and more asthma~     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there~     is evidence that HDMA leads to the development of asthma, in addition to exacerbating~     pre-existing asthma in HDM-sensitised patients.~      ToleroMune HDM is currently being developed for the treatment of HDM allergy.~      The Purpose of this optional observational follow-on study is to evaluate the continued~     efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline~     approximately two years after the completion of the baseline EEC visit in TH002 following~     challenge with HDM allergen in an EEC.~   "
86606|NCT01923779|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed~     all dosing visits in study TG002 approximately one year after the start of treatment.~   "
86607|NCT01923766|"~     In this study, investigators are trying to see if infusion of m-CTLs will prevent or treat~     cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or~     infection after cord blood transplant.~      Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord~     blood transplant (UCBT) from an unrelated donor. After receiving a cord blood transplant,~     they are at risk of infections until a new immune system to fight infections grows from the~     cord blood cells. In this study, investigators are trying to give special cells from the~     cord blood called T cells. These cells will try to fight viruses that can cause infection.~      Investigators will test to see if blood cells from donor that have been grown in a special~     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can~     cause serious life-threatening infections in patients who have weak immune systems after~     transplant.~      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the~     virus infected cells after transplant. Some researcher have taken T cells from a person's~     blood, grown more of them in the laboratory and then given them back to the person during a~     viral infection after a bone marrow transplant. Some of these studies have shown a positive~     therapeutic effect in patients receiving the CTLs (specially trained T cells) after a viral~     infection in the post-transplant period. In this study we are trying to prevent or treat~     viral infections by given the CTLs soon after getting the umbilical cord blood transplant.~      With this study, investigators want to see if they can use a kind of white blood cell called~     T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T~     cells from the cord blood before transplant. These cells have been trained to attack~     adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer)~     T-cells or m-CTL. Investigators would plan to give patients one dose of m-CTL any time~     from 30 to 364 days after your transplant. They have used T cells made in this way from the~     blood of donors to prevent infections in patients who are getting a bone marrow or blood~     stem cell transplant but this will be the first time investigators make them from cord~     blood.~   "
86608|NCT01923753|"~     This is a double-blind randomised controlled crossover study to investigate whether high~     frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in~     patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This~     study will test the hypothesis that the wet weight of sputum expectorated is greater~     following the use of Aerosure than following the use of a sham Aerosure device.~   "
86609|NCT01923740|"~     To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V~     Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic~     heart disease caused by up to two de novo native coronary artery lesions in separate~     epicardial vessels.~   "
86610|NCT01923727|"~     This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an~     immunoPET tracer for metastatic prostate cancer. Individuals participating in this study~     will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the~     injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The~     purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect~     prostate cancer, and optimal time point and dose level for imaging.~   "
86611|NCT01923714|"~     This study aims at validating in real-life clinical practice and using the self-reported~     Glaucoma Symptom Scale (GSS) questionnaire, the impact of a switch to preservative-free~     dorzolamide/timolol fixed combination (DTFC) in patients using preserved topical therapy for~     glaucoma.~   "
86612|NCT01923701|"~     The main objective of this study is to decrease the severity of symptoms and improve~     psycho-social functioning in youth at high risk of developing psychosis by providing a~     specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT).~   "
86613|NCT01923688|"~     The purpose of the project is to improve in-patient safety by lowering the risk of severe~     hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve~     communication between healthcare providers.~      The procedures of the study are:~        -  the hospital patient information system [Pharmacy Event System,(PES)] will generate for~          healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)~        -  the real-time PES risk alert will be sent via a beeper to the patient's charge nurse~        -  the charge nurse will follow the specific guidelines in the alert for assessment of the~          patient's care and insulin regimen~        -  the charge nurse will then notify the physician of the patient's assessment and of the~          recommendation for change/no change in insulin regimen and/or clinical care~        -  the alerted charge nurse and physician will complete a collaboration scale~   "
86614|NCT01923675|"~     1. To determine the effect of spectacles with a red blocking filter on myopia progression~          in children.~        2. To determine the effect of spectacles with a holographic diffuser that spreads incident~          light rays over an angle of 0.5 degrees on myopia progression in children~        3. To determine the combined effects of spectacles with a red blocking filter and a~          diffuser that spreads incident light over an angle of 0.5 degrees on myopia progression~          in children.~   "
86615|NCT01923662|"~     The purpose of this study is to improve the performance of neuroprosthesis for standing~     after SCI by developing and testing new advanced methods that use multiple contact~     peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The~     new advanced methods will take advantage of the ability of multiple-contact nerve cuff~     electrodes to selectively activate portions of a muscle that perform the same action.~     Alternating activation to multiple muscles (or parts of the same muscle) rather than~     continuously activation the entire muscle group constantly should allow them to rest and~     recover from fatiguing contractions. This should allow users to remain upright for longer~     periods of time to perform activities of daily living, reduce the risk of falls due to~     fatigue, and increase the potential of receiving the health benefits of standing.~   "
86616|NCT01923649|"~     The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the~     treatment of dumping syndrome.~   "
86617|NCT01923636|"~     The main objective of this study is to elaborate, in the neonatal period, a prognostic score~     for the development of neurological and sensorineural sequelae at 1 year in neonates~     infected in utero by cytomegalovirus. This score will be based on clinical, imaging and~     biological evaluations.~      The second objective of the study is to estimate the prevalence of this infection in France~     and to describe its epidemiology through the screening of 10,000 consecutive neonates.~   "
86618|NCT01923623|"~     This clinical, randomized, and controlled study will provide valuable scientific evidence~     regarding the effect of adding peripheral nerve blockades to general anaesthesia during~     ankle surgery. In particular, the investigators want to determine if the need for~     postoperative opioids will be reduced and whether this will lead to shorter admission to~     recovery room and fewer instances of side effects such as postoperative nausea and vomiting.~     In addition, the investigators will determine whether the functional outcome is improved~     i.e. faster and more successful rehabilitation. This would have profound benefits not only~     to the individual patient but also to society by reducing expenses during admission, the~     cost of sick leave etc.~   "
86619|NCT01923610|"~     24 healthy male and female volunteers who are at low risk of HIV infection and entered into~     the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of~     MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.~      Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks.~     These visits will comprise:~        -  Screening~        -  Trial entry and boosting immunisation~        -  Early follow-up after immunisation~        -  Follow-up x 2 including the final visit Participants will have blood and urine~          collected, and receive 1 immunisation. They will be counselled prior to and following a~          HIV test, and given health education on prevention of sexually transmitted infections~          including HIV. T~      The two centres which participate are:~        -  Hospital Clinic, Barcelona and~        -  Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and~          immunogenicity of MVA-B.~   "
86620|NCT01923597|"~     The purpose of this study is to determine the safety and effect of green tea~     (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.~   "
86621|NCT01923584|"~     The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's~     disease.~   "
86622|NCT01923571|"~     Intraoperative blood glucose concentration abnormalities are associated with increased~     perioperative morbidity and mortality (1-4). Severe intraoperative hyperglycemia (BGC ≥ 200~     mg/dl) in patients undergoing craniotomy for urgent/emergent craniotomy after traumatic~     brain injury complicates 15% of the cases and is associated with higher in-hospital~     mortality. Intraoperative use of dexamethasone during craniotomy is also known to induce an~     increase in blood glucose concentration.~      The importance of blood glucose concentration in neurosurgical patients is witnessed by the~     effects of tight blood glucose control on incidence of infections and neurological outcome .~     Currently available evidence suggest that, in neurosurgical patients, perioperative BGC~     values should be within the 80-180 mg/dl range .~      Data on the prevalence of severe intraoperative hyper (blood glucose concentration >180~     mg/dl) and hypoglycemia (blood glucose concentration <80 mg/dl) in patients undergoing~     craniotomy for supra or infratentorial surgery as elective or emergency procedure are~     lacking as it is not known whether in these patients intraoperative severe hyperglycemia~     relates to an increased incidence of postoperative infections is unknown.~      Aim of this prospective observational study -in patients undergoing craniotomy for supra or~     infratentorial surgery as elective or emergency procedure- was to test the hypothesis that~     severe intraoperative hyperglycemia (blood glucose concentration ≥180mg/dl) is associated~     with an increased incidence of infections within the first postoperative week (pneumonia,~     sepsis, urinary and wound and cerebral infections). We also recorded the prevalence of~     severe intraoperative hyper and hypoglycemia (blood glucose concentration<80 mg/dl) in~     recruited patients.~   "
86623|NCT01923558|"~     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two~     different formulations of donepezil after a single oral dose administration under fasting~     conditions.~   "
86624|NCT01923545|"~     This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety~     compared to daily G-CSF in chemotherapy-induced neutropenia.~   "
86625|NCT01923519|"~     The respiratory epithelium plays a leading role in the development of allergic respiratory~     disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the~     ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have~     reached concomitant ENT: the concept of one airway, one disease. Access to this material~     of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal~     and bronchial epithelial tissues reveal essential differences in particular related to their~     environment (remodeling less intense and a lower sensitivity to the virus in the nose), but~     they nevertheless share many common cellular characteristics.~   "
86629|NCT01923467|"~     This project is designed to test the effects of affirmation and positive/negative imagery on~     individuals' thoughts about quitting smoking and willingness to join a stop smoking program.~     Previous studies have noted that viewing negative images elicits a stronger emotional~     response, and many stop-smoking campaigns have used such images to push people to quit~     smoking. However, research also shows that people are generally resistant to health~     messages. Using affirmation can help to lessen that resistance.~      In this study, we use a 2x3 design to study the individual effects of negative imagery and~     affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit~     smoking program, and program participation and outcomes. We hope to find out whether there~     is an additive effect of the negative imagery and affirmation on the outcomes listed above.~     Our specific aims are:~      Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking~     program.~      Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of~     the stop smoking program offer.~      Aim 3: Determine whether there is an interaction between image type and affirmation in~     people's willingness to join a stop smoking program.~   "
86630|NCT01923454|"~     This study was to evaluate the efficacy and safety of immediate anterior chamber~     paracentesis (ACP) with a 30-gauge needle as an initial treatment for acute primary angle~     closure (APAC).~   "
86631|NCT01923441|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide~     both a noninvasive and portable measure of brain function. The ERPs provide excellent~     temporal information, but spatial resolution for ERPs has traditionally been limited.~     However, by using high-density electroencephalograph (EEG) recording spatial resolution for~     ERPs is improved significantly. The paradigm for the current study will combine~     neurophysiological knowledge with mathematical signal processing and pattern recognition~     methods (BNA™) to temporally and spatially map brain function, connectivity and~     synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~   "
86632|NCT01923428|"~     This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate~     the safety and efficacy of three dose levels of AZD1722 in subjects with constipation~     predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as~     determined during a two-week screening period. Subjects who qualify and are randomized into~     the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive~     weeks. At the end of this treatment period, subjects will be followed for an additional 4~     weeks.~   "
86633|NCT01923415|"~     The purpose of this study is to characterize the clinical and molecular profiles of patients~     with cutaneous lupus.~   "
86634|NCT01923402|"~     This study was conducted to develop biomarkers of tobacco effect that would indicate~     potential harm related to tobacco consumption. To gain a better understanding of chronic~     effects of tobacco consumption, this cross-sectional clinical study enrolled generally~     healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco~     products (NTC).~   "
86635|NCT01923389|"~     This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of PF-05231023.~   "
86636|NCT01923376|"~     The purpose of this study is to evaluate whether the use of polyethylene glycol is superior~     and more safe in treating hepatic encephalopathy compared to lactulose and also to determine~     if treatment with polyethylene glycol will reduce the duration of hospital stay.~   "
86637|NCT01923363|"~     Worldwide rates of obesity have doubled in the last 30 years, and obesity has been~     associated as a risk factor for hospital-acquired infections and increased occurrence of~     death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed~     antibiotic for critically ill patients with an infection, however, limited information~     exists for dosing this drug in obese patients. In these limited reports, standard doses of~     piperacillin/tazobactam given to the small number of obese patients resulted in lower blood~     concentrations, which could lead to inadequate killing of bacteria. The purpose of this~     study is to compare blood concentrations from standard piperacillin/tazobactam dosing~     compared to higher dosing regimens in obese patients. This study will also include~     information on the safety and tolerability of the higher dose regimens. The study~     investigators believe that the higher dosing regimen will produce adequate blood levels in~     obese patients and will not add any more risk of harm to obese patients receiving this~     higher dose.~   "
86638|NCT01923350|"~     The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the~     effectiveness of interventions that potentially increase the adoption of Diabetes Prevention~     Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus~     (GDM).~      The study was conducted as an integrated trial with two separate arms: one to facilitate~     weight reduction and the other to increase diabetes testing.~      There were two hypotheses:~        1. Women in the testing intervention will be more likely to have received a diabetes test~          within the 6 months post-intervention than women in the control group.~        2. Women in the weight reduction intervention will have lost more weight at the 6-month~          and 9-month follow-up than women in the control group.~      The primary study aim was to determine the efficacy of a system of interactive~     technology-based supports to prompt women with a history of gestational diabetes to take~     steps to prevent diabetes. The secondary aims were focused on women's engagement:~        -  To evaluate the impact of the weight reduction intervention in terms of participant~          engagement with the interactive technology-based supports.~        -  To evaluate changes in the women's perception of their personal diabetes risk following~          after exposure to information about diabetes risk following a pregnancy with GDM.~        -  To identify the determinants and motivators of and barriers to diabetes testing in the~          6- to 12-week postpartum period and thereafter, using the Health Belief model to guide~          the study.~      There was an additional secondary aim involving metformin:~        -  To evaluate the impact of the diabetes risk reduction intervention in terms of women~          seeking out their physician's advice on metformin treatment and receiving a metformin~          prescription, if appropriate.~   "
86640|NCT01923324|"~     The purpose of this study is to investigate whether pain control for patients with chronic~     pain is improved by the availability of structured telephone consultations between the~     patients' family physicians and pain physicians, compared to pain control for patients~     receiving usual care.~   "
86641|NCT01923311|"~     This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of~     ritonavir (RTV)-boosted elvitegravir (EVG/r). This study will also evaluate the safety,~     tolerability, and antiviral activity of elvitegravir (EVG) administered with a background~     regimen containing a ritonavir-boosted protease inhibitor (PI/r) in HIV-1 infected,~     antiretroviral (ARV) treatment-experienced pediatric participants.~      The study consists of 2 parts: Part A and Part B. Part A will enroll participants with~     suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current ARV regimen (HIV-1 RNA >~     1,000 copies/mL) to evaluate the steady state PK and confirm the dose of EVG. Part B will~     enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to~     evaluate the safety, tolerability, and antiviral activity of EVG.~   "
86642|NCT01923298|"~     Estrogen receptor positive breast cancer is the most common type of breast cancer and~     anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side~     effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood~     changes and vaginal dryness/pain. Vaginal symptoms including pain, dryness, itching,~     bleeding after intercourse and frequent urinary tract infections have been reported to cause~     significant morbidity in postmenopausal women and higher in breast cancer survivors on~     anti-estrogen therapy. Treatment options include vaginal lubricants, Replens etc but~     unfortunately many women continue to have persistent symptoms. Local estrogen has been shown~     to be effective in post menopausal women (Estring or Vagifem) for their vaginal symptoms.~     There is a concern of using this in women with breast cancer given it may increase their~     blood estrogen levels. Studies done so far show have shown controversial results but~     majority of them report that blood estrogen levels do not change significantly. The major~     drawback of the studies was the sample size and inadequate accrual. The most recent trial~     reported showed no significant change in blood estrogen levels in women with breast cancer~     treated with aromatase inhibitors (anti-estrogen therapy) and were on vagifem for their~     vaginal symptoms. The authors reported results in 26 patients and reported no significant~     change in blood estrogen level. We propose to study the change in blood estrogen level when~     postmenopausal women with breast cancer who are currently on aromatase inhibitors are~     treated with Estring for their vaginal symptoms.~   "
86643|NCT01923285|"~     The purpose of this study is to evaluate the safety and effectiveness of the AXIUM~     Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed~     with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).~   "
86644|NCT01923272|"~     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled~     pilot study is to study feasibility and collect additional preliminary clinical data related~     to the safety and clinical benefits of non-invasive vagal nerve stimulation with the~     AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction,~     and to support the development and approval of a larger pivotal study.~      The objectives of this study are (1) to gather preliminary safety and efficacy data of the~     AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB~     (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as~     an effective control for use in future clinical studies, and (3) to support the development~     and approval of a pivotal study, confirm data collection methods and endpoint definitions,~     and confirm appropriateness of the subject follow up plan.~   "
86645|NCT01923259|"~     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two~     different formulations of donepezil after a single oral dose administration under fed~     conditions.~   "
86646|NCT01923246|"~     The primary aim of the present study is to study the effect of a brief automated alcohol~     intervention in University students, and if there is a difference in effect between~     automated brief interventions delivered by internet (WEB) or Interactive Voice Response~     (IVR), and to study if there is difference in effect between single and repeated~     interventions.~   "
86647|NCT01923233|"~     This study is an individualized anti-cancer vaccine protocol where the vaccination occurs~     inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a~     process called Radiofrequency Ablation or RFA. RFA causes the tumor to release its~     internal contents to the surrounding environment, such contents include tumor-specific~     antigens. Immune cells respond to the tissue damage and take-up these tumor antigens. The~     injection of the experimental cell drug, AlloStim(TM) into the lesion is designed to cause~     the responding cells to signal the immune system of the danger of the tumor, creating~     tumor-specific immunity.~   "
86648|NCT01923220|"~     This is a single-center, open-label, randomized, prospective study evaluating the safety and~     efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment~     fields vs. standard of care (SoC), Aloe Vera treatment~   "
86649|NCT01923207|"~     The purpose of this study is to assess the safety and tolerability of the study drug~     (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to~     receive DX-2930 or placebo.~   "
86650|NCT01923194|"~     Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to~     Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females~   "
86651|NCT01923181|"~     This trial is conducted globally. The aim of the trial is to examine the dose range,~     escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.~   "
86652|NCT01923168|"~     The purpose of the study is to determine whether treatment with a PI3K inhibitor plus~     letrozole leads to an increase in pathologic clinical response and Objective Response Rate~     compared to treatment with placebo plus letrozole in patients with Breast cancer~   "
86674|NCT01922882|"~     The purpose of this trial is to test whether, compared to the normal Standard of Care at~     primary health care clinics, a home-based counseling intervention ( the 'Amagugu' Counseling~     Intervention), will increase the number of HIV-infected mothers who are able to disclose~     their own HIV status to their primary school-aged children. The investigators also wish to~     examine whether the intervention improves the quality of the maternal-child relationship,~     emotional and well-being of the child and social support.~   "
86653|NCT01923155|"~     There is no theoretical or practical reason why non-medical personnel such as nurses could~     not be trained to perform diagnostic colonoscopy with comparable proficiency as medical~     endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the~     past 15 years as a valuable resource to cope with the increasing demand for endoscopic~     service, in particular diagnostic colonoscopy for colorectal screening. A pilot study~     performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform~     diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly~     trained nurse endoscopists have a comparable proficiency in performing colonoscopy~     procedures as their medical counterparts.~   "
86654|NCT01923142|"~     The purpose of this study is to evaluate the hypothesis that, in patients with stable~     vitiligo unresponsive to conventional treatments including traditional phototherapy and/or~     topical steroids, the application of a non-cultured autologous hair follicle~     outer-root-sheath melanocytes suspension in the area affected by the disease followed by~     targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To~     assess the effect of the proposed treatment, a within-subject controlled study involving~     selected symmetric lesion areas localized to the back of the hands will be conducted.~   "
86655|NCT01923129|"~     There is no general agreement about the optimal duration of postoperative urinary drainage,~     with relevant literature reporting durations ranging from 1 to 10 days. The available~     research supporting the routine use of prolonged catheterization is limited and studies~     investigating early removal following infraperitoneal colorectal surgery have largely been~     underpowered to form valid practice conclusions. The aim of the investigators study is to~     determine whether a postoperative colorectal patient can safely have an indwelling catheter~     removed on postoperative day one (24 hours following surgery) with the addition of a study~     medication (prazosin), without a statistically significant difference in the incidence of~     urinary retention compared to the standard, accepted approach of delayed removal (72 hours~     postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below~     the peritoneal reflection for both benign and malignant conditions will be randomized into~     two groups: group one will have the catheter removed on postoperative day 3 (72 hours~     postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior~     to catheter removal and will have the urinary catheter removed on postoperative day 1 (24~     hours postoperatively).~   "
86656|NCT01923116|"~     The objective of the study is to assess, in a phase 1/2 study, the safety and efficacy of~     this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and~     HPV16-induced intra-anal high-grade AIN (grade 2-3) that failed on, or recurred after~     previous treatment.~   "
86657|NCT01923103|"~     Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and~     fingers, which may lead to extension deficits of the fingers. The disease can be very~     disabling in moderate and severe cases, whereby performing normal daily activities can~     become very problematic. The aetiology and pathogenesis are not completely understood. There~     is a genetic disposition and it is influenced by environmental factors. The disease is~     especially prevalent in white males of Northern European descent above 50 years of age.~     There is paucity of knowledge about the natural progression of the disease. Several studies~     have been conducted on progression of disease and from these studies it becomes obvious that~     the disease is progressive over several years. However, in most studies only one moment of~     follow-up has taken place, so the course of the progression over time is unknown.~      The aim of this study is to enhance our knowledge on the natural disease progression of DD~     at different stages.~   "
86658|NCT01923090|"~     The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is~     important in controlling how the body handles sugar and fat. The investigators believe that~     5αR is a crucial step in regulating these actions as well as controlling how insulin works~     in the body but regulating the amount of steroid hormones including cortisol and~     testosterone in the body. In previous clinical studies, the investigators have shown that~     the activity of 5αR increases as you gain weight and decreases with weight loss. In~     addition, work that the investigators have performed in the laboratory has shown that if you~     increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they~     contain increases. The investigators would therefore like to demonstrate the effect of~     inhibition 5αR on the regulation of insulin, glucose and fat in the body.~   "
86659|NCT01923077|"~     Objective: Statins have been shown to have beneficial pleiotropic effects besides being~     lipid lowering. The investigators hypothesized that early and intensive statin treatment was~     associated with improved left ventricular (LV) function and with a stabilization of the~     coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method:~     In a prospective randomized blinded endpoint trial patients with ST segment elevation or non~     ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose~     rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin~     therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators~     performed echocardiography at randomization, after 30 days and after 12 month. The~     investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque~     assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month.~      Primary outcome for this study was assessment of LV function with global and regional~     myocardial strain. Secondary outcomes can be divided in 4 groups:~        1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume,~          atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.~        2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM,~          E-selection and Nitrate/Nitrite ratio.~        3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability.~        4. Long term follow-up: Mortality and cardiovascular events~   "
86660|NCT01923064|"~     The purpose of this randomized study to compare effect of endoscopic injection of a mixture~     of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.~   "
86723|NCT01922245|"~     This project will investigate the use of noninvasive brain stimulation in the form of tDCS~     (transcranial direct current stimulation) in conjunction with speech-language therapy, for~     the improvement of language production in stroke survivors with aphasia. The hypothesis is~     that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to~     speech therapy alone.~   "
86661|NCT01923051|"~     The chronic obstructive pulmonary disease (COPD) is the occurrence of chronic bronchitis or~     emphysema, a pair of commonly co-existing diseases of the lungs in which the airways narrow~     over time. This limits airflow to and from the lungs, causing shortness of breath~     (dyspnoea). In clinical practice, COPD is defined by its characteristic airflow limitation~     on lung function tests. In contrast to asthma, this limitation is poorly reversible and~     usually gets increasingly worse over time.~      The COPD registry is a non-interventional multicentre observational prospective database~     focusing on the collection and analysis of data on real mortality and morbidity in COPD~     population of the Czech Republic population of COPD patients. Monitoring is done at the~     occasion of regular check-ups, followed by retrospective search of data in the~     documentation, and a record into the registry.~      The aim of Czech National Research Database of Chronic Obstructive Pulmonary Disease is to~     establish the clinical course of severe forms of COPD, establish the cause for deterioration~     of clinical status of our patients and describe the progression of COPD to death.~      The registry fulfils general objectives of health registries such as monitoring of causes,~     development, treatment and consequences of a severe disorder, including economic and social~     impacts. Statistical and scientific analyses of the registry data are focused, in~     particular, on the assessment of health determiners of the selected patient cohort with the~     aim to improve health status of the patients.~   "
86662|NCT01923038|"~     Atelectasis involving declive areas often occurs during general anesthesia and may persist~     postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg~     position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve,~     Stress Index (SI), during constant flow inflation can lead ventilator setting during general~     anesthesia.~   "
86663|NCT01923025|"~     This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy~     Relationship of RO5545965 after a single dose in healthy male volunteers by positron~     emission tomography (PET).~   "
86664|NCT01923012|"~     Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid~     stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the~     calcified component.~   "
86665|NCT01922999|"~     The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD~     patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic~     episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients~     with sleep disordered breathing.~   "
86666|NCT01922986|"~     When a certain area of the brain is injured, like in stroke, several events occur. One side~     of the body may become weak. This weakness is called hemiparesis and it may create~     difficulty in performing tasks like writing, eating, and walking. The weakness results from~     two sources:~        1. death of some brain cells in the affected side (hemisphere) of the brain~        2. exaggerated inhibitory signals from the unaffected hemisphere acting on surviving~          neurons in the affected hemisphere.~      Investigators cannot change neurons that have died but they may be able to change the~     exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The~     purpose of this study is to try to decrease the exaggerated inhibition coming from the~     unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic~     stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS~     combined with conventional therapy will produce greater functional gains in the paretic hand~     compared to sham rTMS combined with conventional therapy, as measured by standard tests.~   "
86667|NCT01922973|"~     The overall objective of this study is to determine the extent to which circulating ghrelin~     levels (total and bioactive ghrelin) are regulated by nutritional state and age.~   "
86668|NCT01922960|"~     Predict the development of multiple organ failure in patients with trauma and severe burns.~   "
86669|NCT01922947|"~     The purpose of this research is to test the feasibility and efficacy of a brief (one~     session) preventative intervention using motivational interviewing integrated with social~     network counseling for substance use among adolescent patients in a primary care setting.~     One hundred participants will be randomly assigned to either motivational interviewing~     integrated with social network counseling or attention control conditions. The motivational~     interviewing integrated with social network counseling condition is expected to show~     improvement when compared to the attention control condition.~   "
86670|NCT01922934|"~     Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension,~     high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to~     be effective for treating obesity. Treatments include lifestyle modification, meal~     replacements, and weight loss medication. Most primary care settings do not provide much~     obesity treatment, though, as primary care providers (PCPs) are not well trained and because~     reimbursement for treatments is not consistent.~      Hypothesis: If PCPs have training in weight management and if most costs of treatment are~     reimbursed, we surmise that a toolbox of treatments can produce a clinically important~     weight loss amount in a large group of patients.~      Design: We propose to establish a registry of obese patients with at least one common~     medical condition related to their weight. From the registry, we will randomly select 350~     people to be offered treatments to assist with weight loss. The remainder of the registry's~     patients can still receive obesity treatment but will not be reimbursed. We will conduct the~     study at Denver Health, a large public health care system that treats a low income,~     ethnically diverse population. All 350 patients will be offered some self-monitoring tools~     for weight management and the chance to do a computer assessment to select the right~     treatment for weight loss. Patients who complete this and record their food intake and~     physical activity for 1 week will be offered a Level 2 treatment for weight loss. Level 2~     treatments include: a voucher for a commercial weight loss program; intensive group weight~     loss counseling; meal replacements; gym membership; or weight loss medication. Patients will~     choose which treatment they want, with the approval of their PCP. Researchers at Denver~     Health will help with the computer assessment and dispensing the treatments. We are~     interested in what percentage of patients lose at least 5% of their starting weight. We will~     also explore changes in glucose, blood pressure, and cholesterol, and we will look at how~     much this intervention costs and whether patients need less medication for their~     weight-related conditions at the end of the study.~      Impact: If the study is successful, we plan to take the results to the leaders at Denver~     Health to see if they will make obesity treatment more broadly available for all patients~     there.~   "
86671|NCT01922921|"~     This randomized phase I/II trial studies the side effects of vaccine therapy with or without~     polysaccharide-K and to see how well it works in treating patients with stage IV human~     epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving~     HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain~     (ICD) peptide may help the body build an effective immune response to kill tumor cells that~     express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop~     tumor cells from growing. It is not yet known whether vaccine therapy works better when~     given with or without polysaccharide-K in treating breast cancer.~   "
86675|NCT01922869|"~     The era of general dietary recommendations for the whole population may be coming to an end,~     as it is becoming apparent that we are all unique and do not respond in the same way to the~     same foods. Within a decade it is believed that doctors will be able to take profiles of~     their patients, identify specific diseases for which they are at risk and create~     personalised nutrition plans accordingly. At the University of East Anglia, UK the~     investigators are interested in particular food compounds known as flavonoids which can be~     found in foods such as chocolate, orange juice and blackberries (COB). The study will~     determine if factors such as age, gender, genetics and the bacteria present in our guts~     contribute to variability between individuals in their absorption, metabolism and excretion~     of flavonoids.~   "
86676|NCT01922856|"~     The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic~     E. coli (ETEC)-caused diarrhea.~   "
86677|NCT01922843|"~     The goal of this study is to test a new vitamin D compound for its ability to reduce~     parathyroid hormone levels in patients who are on hemodialysis.~   "
86678|NCT01922830|"~     This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo~     treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy~     surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment~     initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests,~     anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and~     questionnaires for demographic details, quality of life, food intake, food tolerance and~     habitual physical activity. 20 subjects will undergo an additional liver-MRI test at~     baseline and M6.~   "
86679|NCT01922817|"~     Ninety years ago the discovery of insulin and its development as a drug revolutionized the~     management of type 1 diabetes, which until that point had almost inevitably proven fatal.~     However, very rapidly it was recognized that like all wonder drugs there were problems~     with insulin. Elliot Joslin, one of the pioneers of diabetes therapy described insulin as~     …a potent preparation alike for evil and for good(1922). There are two major reasons for~     this. Firstly, in non-diabetic individuals insulin produced by the pancreas acts directly on~     the liver, the major organ for regulating blood glucose levels. In contrast, people with~     type 1 diabetes inject insulin under the skin, and this is then absorbed into the~     circulation and much of it is degraded (~50%) before it gets to the liver. This means that~     in order to act effectively in the liver a type 1 diabetic needs to inject at least double~     the amount of insulin. Many studies have now shown that high insulin levels lead to weight~     gain, accelerated blood vessel disease (atherosclerosis) and a higher risk of suffering low~     blood glucose (hypoglycaemia). A second major problem is that individuals with type 1 show~     high levels of the hormone, glucagon. Glucagon is also produced in the pancreas and is~     normally regulated by pancreatic insulin, so the loss of this effect in people with type 1~     diabetes means they run high glucagon levels. This has been shown to increase blood glucose,~     particularly after a meal. It is because of this that the diabetes community has called for~     novel therapies that can reduce high insulin levels and high glucagon levels. A new class of~     drugs called dipeptidylpeptidase IV inhibitors (DPPIVi) are currently used to treat people~     with type 2 diabetes. DPPIV inhibition increases endogenous levels of glucagon like~     peptide-1 (GLP-1). These drugs have a number of actions but the most relevant to this~     application is that they directly suppress glucagon, induce satiety (i.e. reduce hunger and~     leads to a reduction in body weight) and indirectly reduce the need for high dose insulin~     injections. This makes them an ideal candidate drug as an insulin sparing or adjunct therapy~     in type 1 diabetes, but there is very limited data to date for this use. We would like to~     run a small, pilot, randomised, cross over trial that investigates the potential for DPPIVi~     therapy to reduce insulin requirements in type 1 diabetes. We would like to investigate to~     see if this drug reduces daily insulin doses, leads to weight reduction, reduces blood~     glucose fluctuation and improves glucose control. Through reduction of blood glucose~     variability, we want to investigate, whether it has the capability of improving the~     magnitude of epinephrine responses at 2.5mmol/L by performing a hyperinsulinaemic,~     hypoglycaemia clamp study after each arm. A successful outcome would then lead to an~     application for funds for a larger, multicentre intervention study. The benefits of this~     therapeutic advance are clear and this has the potential to make a dramatic improvement to~     the lives of people with type 1 diabetes in our community.~   "
86680|NCT01922804|"~     The aims of the present study are to investigate the effect of vitamin K2 on bone turnover,~     bone mass, bone structure, glucose metabolism, and arteriosclerosis.~      Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases~     that affect large groups of people in the Western world.~      Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in~     postmenopausal women and reduces bone turnover and increases bone mineral density; increases~     insulin sensitivity and decreases indices of arterial calcification.~   "
86681|NCT01922791|"~     A randomized double-blind placebo controlled intervention study with pregnant obese women~     (n=440) will be conducted. The intervention will involve consumption of fish oil and/or~     probiotic capsules from early pregnancy until 6 months after delivery.~      The aim of the study is firstly to investigate the effects of the supplements on the risk of~     gestational diabetes mellitus and obesity in the women and secondly to modify the risk~     markers of allergy and obesity in children of the women. Also the underlying metabolic~     mechanisms will be investigated.~   "
86682|NCT01922778|"~     The purpose of this study is to develop an endometrial biopsy screening program for~     endometrial cancer and its precursor lesions in overweight and obese women.~      There is a BMI threshold at and above which optimal screening parameters exist for~     identifying endometrial cancer and its precursor lesions in overweight and/or obese women.~     Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in~     overweight and/or obese women offers substantial health benefits.~   "
86683|NCT01922765|"~     If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin,~     rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with~     amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole~     for 5 days(sequential), amoxicillin, clarithromycin, metronidazole,~     rabeprazole(concomitant), then the eradication rate of concomitant group will be the~     highest.~   "
86684|NCT01922752|"~     The primary objective is to determine the maximum tolerated dose (MTD), safety, and~     tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic~     solid tumors.~   "
86685|NCT01922739|"~     This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety~     of hydrocodone bitartrate extended-release tablets in patients with moderate to severe~     chronic low back pain who require continuous opioid treatment for an extended period of~     time.~   "
86686|NCT01922726|"~     The purpose of the study is to evaluate at 12 Months follow-up the association between~     Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in~     REPLY 200 DR pacemaker.~   "
86687|NCT01922713|"~     The purpose of the study is to determine whether daily consumption of beta-carotene~     biofortified maize will increase breast milk retinol concentration in lactating Zambian~     women.~   "
86688|NCT01922700|"~     Pepper sprays and pepper gas grenades are used by riot police at various places in the world~     for crowd control. Data about the acute effects based on human studies is extremely scarce.~     Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political~     turmoil for the past 22 years and incidents of stone pelting are common wherein groups of~     youth indulge in stone pelting at the security personnel. While there have been previous~     episodes of fatalities associated with incidents of firing by the security personnel; non~     lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and~     more recently the pepper gas grenades. The pepper grenades explode in the area and the~     adverse effects are perceived by the population in the area too who are even sitting in~     their homes. The study proposes to observe the health effects of the pepper gas exposure in~     non-combatant civilians.~   "
86689|NCT01922687|"~     The primary objective of this study is to test the hypothesis that amlodipine plus~     atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc),~     has a stronger effect in protection of arterial structure and function.~   "
86690|NCT01922674|"~     Purpose: To determine if observation (watchful waiting is a safe alternative to routine~     repair of asymptomatic inguinal hernias in adult males.~      Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at~     diagnosis to prevent the life threatening complications of bowel obstruction or~     incarceration with strangulation and that operation becomes more difficult the longer a~     hernia is left un-repaired.~   "
86691|NCT01922661|"~     The primary objective of the study is to assess the safety and tolerability of single~     ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult~     subjects.~   "
91473|NCT01859897|"~     The objective of this five-year prospective observational follow-up study is to examine the~     additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of~     cardiovascular events in high-risk patients.~   "
86692|NCT01922648|"~     Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single~     most important cause of severe respiratory illness in infants and young children, and severe~     RSV infection early in life is associated with an increased risk of later developing asthma.~     RSV also causes severe disease in elderly and immune-compromised adults, and the amount of~     RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in~     the secretions of the upper respiratory tract of infected individuals and by contact with~     contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and~     neonatal wards, are not uncommon.~      Infection by RSV does not develop a natural long-lasting protection against re-infection~     (like, for example, measles does). In the USA nearly all children by 24 months of age have~     been infected at least once with RSV, and about half will have experienced two infections.~     There is no effective anti-viral drug to treat an infection and the only way of managing~     cases of severe infection is through supporting organs, such as the lungs, to withstand and~     recover from the illness.~      There remains a real need to develop an effective vaccine to prevent severe infections~     caused by RSV. A better understanding of the way the immune system responds to RSV in~     children would aid the development of such a vaccine.~      The purpose of this study is to increase our understanding of how the immune system responds~     to RSV. Only limited data is available on some important components of the immune response~     and this study is designed to measure these in more detail. This is done using a single~     blood sample.~      A total of 35 children are anticipated to be recruited to this study, at ages when we expect~     to see differences in the immune response to RSV;~        -  5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV~        -  20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one~          single RSV season in the winter of 2011/12~        -  10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over~          several winter seasons~   "
86693|NCT01922635|"~     The constitutional lymphœdema is a rare disease with an annual incidence before the age of~     20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly~     the prognosis for survival, alter the body image imposing a visible deformity and of which~     the treatment which aims at reducing and at stabilizing the physical deformation is binding~     and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the~     everyday life of the child and on the family environment. This question is all the more~     important, that all the studies show that the success of the treatment bases on the~     compliance in the concentration and in the care of hygiene. The parameters of the success of~     these treatments at the child are not known.~   "
86694|NCT01922622|"~     Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients~     with multiple comorbidities. Anaesthetic management of this patient group is extremely~     challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents~     administered via a spinal catheter leads to better cardiovascular stability.The minimum dose~     of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study~     and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20~     mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for~     the operative fixation of FNF.We will use a previously well established Dixon and Massey~     up-and-down method to calculate initial MLAD in this prospective, observational trial.~      Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of~     fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on~     the side of FNF.~      Outcomes~      Primary outcome:~        1. Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up~          to T10 on the side of FNF.~           Secondary outcomes:~        2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative~          fixation of fractured neck of femur.~        3. The effect on haemodynamic variables (blood pressure, heart rate).~        4. Incidence of side effects~        5. The length of postoperative analgesia (the time from the last dose of local anaesthetic~          administered intrathecally to VAS>3).~        6. The time to first rescue analgesic requirement~      Study Design Prospective, observational trial.~      Study Size Based on the previously well established Dixon and Massey up-and-down~     method(10), we will recruit patients until a successful spinal block has been achieved in~     six consecutive patients who received a specific dose. This is the requirement to calculate~     the initial MLAD.~   "
86695|NCT01922609|"~     The aim of this observational pilot study is to determine whether intolerance of carotid~     occlusion during carotid artery stenting can be predicted with preprocedural transcranial~     Doppler evaluation.~   "
86696|NCT01922596|"~     The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a~     Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe~     pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.~   "
86697|NCT01922583|"~     This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR~     T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged~     NSCLC.~   "
86698|NCT01922570|"~     Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients~     with a functioning digestive tract. Nevertheless, EN alone is often associated with~     digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or~     discontinued, resulting in insufficient energy and protein intakes and increase~     complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN~     that in those without EN or on Parenteral nutrition (PN). This difference is likely to be~     related to the level of EN administration needed to optimize the coverage of nutritional~     needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have~     a negative economic impact on global cost, because the management of patients with diarrhoea~     is time-consuming for the nurses and all medical staff, it requires investigations (water~     and electrolytes balances, microbiology investigations, etc.) and treatments~     (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related~     to EN or the combination of EN and PN has never been evaluated in the ICU setting.~   "
86699|NCT01922557|"~     To study the association of the thoracic fluid content and acute lung injury during liver~     transplantation.~   "
86700|NCT01922544|"~     In patients undergoing CRT device implantation a lead positioning in the coronary sinus is~     required. Even this part of the surgical procedure is challenging. In this study we compared~     retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.~   "
86701|NCT01922531|"~     To measure Axonal Injury in children with mild traumatic brain injury enrolled in an~     Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.~   "
86702|NCT01922518|"~     Typically pacemaker electrode has been attached to the right ventricular apex. This method~     lead to Non-physiological Ventricular contraction. It has been reported to cause by~     ventricular dysfunction. In conclusion, this study demonstrate that impact of right~     ventricular pacing determined by electrocardiography was planned.~   "
86703|NCT01922505|"~     The purpose of this study is to investigate the trend of eradication rates of first-line~     triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect~     the eradication in Korean.~   "
86704|NCT01922492|"~     -  Effects of autologous islet transplantation were compared to those of oral~          anti-diabetic drugs after distal pancreatectomy.~        -  The primary interest is a insulin-secretory function after the surgery in two~          intervention groups.~   "
86752|NCT01921868|"~     The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will~     affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other~     symptoms of Friedreich's Ataxia such as difficulties with balance, walking, or upper arm~     function.~   "
86705|NCT01922479|"~     Heart failure (HF) is a major global public health issue which also affects Asia. Data from~     the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public~     hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a~     common problem occurring in HF, ranging from 14% to 56% in outpatient registries and~     clinical trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise~     intolerance, thereby reducing quality of life (QoL). However, recent approaches aimed at~     improving and normalizing Haemoglobin have been unsuccessful.Novel approaches are required~     to address this problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID~     without overt anaemia may be present in HF patients. A recent study by Jankowska et al~     published in 2010 of 546 HF patients showed a 37% prevalence of ID, regardless of~     Haemoglobin level. This was associated with worse outcomes including impaired exercise~     capacity. The presence of ID indicates a higher likelihood of deteriorating and dying early.~     A landmark study published in the New England Journal of Medicine (The Ferinject Assessment~     in Patients with Iron Deficiency and Chronic Heart Failure (FAIR-HF) study) showed that HF~     patients who were treated with IV iron in the form of Ferric Carboxymaltose (FCM) had better~     outcomes, including improved exercise capacity, overall function, and quality of life.~      There is a lack of contemporary data on ID in HF patients in Asia, including data on~     treatment with this novel IV iron FCM.~      Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve~     outcomes including exercise capacity, quality of life, overall functional status, and the~     need to be hospitalised for complications arising from HF.~   "
86706|NCT01922466|"~     The purpose of this study is to evaluate the efficacy and safety of east-west collaborative~     treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and~     quality of life of patients with chronic cervicalgia~   "
86707|NCT01922453|"~     This international study is looking to see if the addition of music and sound on the~     maternal abdomen encourages fetal position change from breech to vertex in near term women.~   "
86708|NCT01922440|"~     This is a prospective, observational, natural history registry, designed to collect data on~     patients with chronic hypoparathyroidism. No study-defined procedures will be required, and~     if available, a select set of data will be collected at baseline and at least annually.~   "
86709|NCT01922427|"~     The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery~     decreases pain and improves functional capacity post-operation.~   "
86710|NCT01922414|"~     This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in~     disintegration of staghorn stones during percutaneous nephrolithotomy.~   "
86711|NCT01922401|"~     for evaluating inverse ratio ventilation of laparoscopic bariatric surgery~   "
86712|NCT01922388|"~     Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical~     treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is~     lacking. This study is intended to demonstrate that early, compared with delayed,~     introduction of STN DBS is more beneficial for PD patients who have developed motor~     complications.~   "
86713|NCT01922375|"~     This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male~     patients with with lower urinary tract symptoms associated with benign prostatic~     hyperplasia.~      The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect~     in improvement of voiding and storage difficulty.~      Design:~      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose~     design~   "
86714|NCT01922362|"~     To compare the efficacy and safety of negative pressure drainage system with controls~     (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin~     graft.~   "
86715|NCT01922349|"~     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in~     healthy Chinese, Japanese and Caucasian male volunteers.~   "
86716|NCT01922336|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and~     immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy~     subjects.~   "
86717|NCT01922323|"~     The PI will study metabolism during liver regeneration in living liver donors~   "
86718|NCT01922310|"~     The overarching aim of this study is to examine the process of organ donation~     decision-making and to determine whether changes in requesting practices change rates of~     consent for donation, and other family-based outcomes.~   "
86719|NCT01922297|"~     This study will determine the clinical effectiveness, moderators and mechanisms of change,~     and economic impact of an integrative, family-based intervention that concurrently targets~     change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse,~     delinquency, arrest and mental health outcomes for juvenile offenders committed to a~     juvenile justice day treatment program.~   "
86720|NCT01922284|"~     UKHVC Spoke 003 is a randomised Phase I, two centre study which will explore the impact of~     shortening a vaccination regimen using deoxyribonucleic acid (DNA) (CN54ENV and ZM96GPN),~     Modified Vaccinia Ankara - C (MVA-C) and CN54rgp140 adjuvanted with glucopyranosyl lipid A~     adjuvant - aqueous form (GLA-AF). The study population will be 40 healthy male and female~     volunteers 18 to 45 years old who are at low risk of HIV infection are to be recruited.~      Study participants will be immunised with trial immunogens:~        -  8mg DNA: one plasmid encoding a gag-pol-nef polypeptide derived from the 96ZM651-8~          clone and one plasmid encoding gp140 env derived from clade C 97CN54~        -  1.108 TCID50 MVA-C (nominal titre) expressing the gag-pol-nef and gp120 env proteins~          derived from clade-C 97CN54~        -  100ug CN54rgp140, a trimeric recombinant envelope protein derived from clade C 97CN54~        -  5ug GLA-AF, an aqueous glucopyranosyl lipid A adjuvant~      All immunisations will be administered by the intramuscular route (IM). CN54gp140 and GLA~     will be mixed together before administration, and immunogens will be delivered in~     combination regimens~   "
86721|NCT01922271|"~     The purpose of this study is to further figure out differences of glycopyrronium bromide~     compared to tiotropium in early bronchodilation measured by a comprehensive assessment of~     lung function that includes hyperinflation and specific airway resistance in patients with~     moderate to severe COPD.~   "
86722|NCT01922258|"~     To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with~     agitation associated with dementia of the Alzheimer's type~   "
86724|NCT01922232|"~     This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers~     predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder~     cancer. Target enrollment of this study is 40 patients. Patients will first undergo baseline~     DW-MRI of the Abdomen and Pelvis prior to beginning standard treatment with neoadjuvant~     cisplatin-based chemotherapy after which DW-MRI will be repeated to assess for response or~     progression. Patients who remain eligible for surgery will proceed to standard radical~     cystectomy with pelvic lymph node dissection. DW-MRI metrics including apparent diffusion~     coefficient (ADC) values will be correlated to pathologic response rate in the radical~     cystectomy specimen to identify imaging markers predictive of response.~   "
86725|NCT01922219|"~     The purpose of this research study is to learn whether specific types of brain imaging and~     psychological testing can predict how much benefit patients with depression will receive~     from a well-studied psychotherapy for depression, called cognitive behavioral therapy (CBT),~     and how the brain imaging and psychological tests change with treatment. We will also be~     comparing brain scans from this study between individuals suffering from depression and~     volunteers without depression.~      This study offers 14 sessions of one-on-one cognitive-behavioral therapy (CBT) over twelve~     weeks, administered by an experienced doctoral-level psychologist or psychiatrist.~   "
86726|NCT01922206|"~     The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct~     a full-scale trial of an intervention to assist mothers living with HIV (MLH) with~     disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot~     study of the intervention has recently been completed (R01 MH077493) and met its major aims.~     The basis for development of the pilot intervention was work from three R01s (MH057207,~     currently Yr. 14) designed to longitudinally assess MLH and their children. Within that~     work, several studies were conducted on maternal disclosure, suggesting disclosure is~     difficult, and outcomes for MLH and children could be improved by intervention. The pilot~     study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was~     based on integrative disclosure theory. Results of the pilot trial indicate that those in~     the intervention group were six times more likely to disclose their HIV/AIDS status to their~     child than those in the control group (O.R. 6.33); by the 9-month follow-up 33% of~     intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more~     importantly, the intervention group's emotional functioning and their satisfaction improved~     significantly following the intervention, compared to the control group. Similarly, child~     mental health indicators among children of intervention MLH were significantly better than~     control group children at follow-ups. In this study, TRACK II, we propose to conduct a~     full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the~     pilot trial was conducted), which will include a high proportion of Latina families and a~     smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2,~     where the primary consultant on the pilot trial conducts research), which will include a~     high proportion of Southern African-American families, as well as White families. MLH and~     their children (N = 440 total; 110 mothers and 110 children per site, n = 220 per site) will~     be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned~     to the intervention or control. Aims are to:~        1. facilitate disclosure of the mothers' HIV status to the children, which will include~          secondary aims of:~             1. increasing mothers' self-efficacy to disclose and respond to child questions~               regarding HIV;~             2. reducing mothers' fears regarding disclosure and stigma;~             3. improving maternal knowledge of child development and how to provide appropriate~               levels of information given the age of the child;~        2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of~          life);~        3. improve child mental health indicators over time (i.e., depression, anxiety, acting out~          behaviors); and~        4. improve family functioning indicators (e.g., cohesion, perceived closeness between~          mother and child).~   "
86727|NCT01922193|"~     Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared~     to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an~     Assisted Reproductive Technology (ART) Program.~   "
86728|NCT01922180|"~     To describe Computed Tomography (CT) features associated with severe exacerbations of~     Chronic Obstructive Pulmonary Disease (COPD).~   "
86729|NCT01922167|"~     Frailty is a clinical entity associated with an increase in risk for disease and death and~     becomes more common as people age. Frailty has a strong relationship with the age-related~     loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly~     associated with disability, especially in women. Adequate protein intake, the amino acid~     leucine, and resistance exercise training have been individually shown to increase muscle~     mass to varying degrees. However, no studies have investigated how a longer-term resistance~     exercise training program with leucine supplementation when protein intake is optimized~     could increase muscle mass in frail and pre-frail elderly women. In addition, this is the~     population that stands the most to gain from such an intervention.~      The purpose of this study is to investigate the effects of the amino acid leucine added to~     resistance exercise training on muscle mass and physical performance in frail and pre-frail~     elderly women with adequate protein intake. We hypothesize that combining leucine in diet~     with an exercise program would be superior to exercise alone in stimulating muscle protein~     synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to~     enhanced gains in muscle performance.~      A total of 24 subjects will take part in this study, conducted at the McGill University~     Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Gériatrie de~     Montréal (IUGM). All subjects will undergo adjustments to their diet to optimize protein~     intake and a resistance exercise training program. Half of the participants will receive a~     supplement of powdered leucine (an amino acid), and the other half of the participants will~     receive a placebo in the same powder form. Neither the participants nor the study~     investigators will know which participants are receiving the leucine nor which are receiving~     the placebo.~      Each subjects participation in this study will involve 4 total visits: 2 initial screening~     visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the~     MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention~     (dietary adjustments, resistance exercise training, and the powdered supplement). The two~     stays each consist of a meal test to assess each subjects metabolic responses to a meal, and~     to obtain muscle biopsies necessary to measure the rate of protein accumulation in the~     muscle. Simple physical performance measurements will be taken before and at the completion~     of the intervention.~      This study aims to better understand how the presence of aging affects the body's responses~     to resistance exercise and how leucine, one of the amino acids that make up proteins, may~     help build muscle. This in turn, could lead to defining combined diet and exercise~     strategies to prevent muscle loss often seen with aging.~   "
86730|NCT01922154|"~     To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for~     trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).~   "
86731|NCT01922141|"~     This study is designed to compare the blood pressure lowering efficacy of aliskiren, a~     combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to~     moderate hypertension. It will also compare the long-term safety of an aliskiren-based~     regimen to a ramipril-based regimen~   "
86732|NCT01922128|"~     Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for~     non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.~   "
86733|NCT01922115|"~     Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of~     this medication is cognitive dysfunction. OAB is more prevalent in the elderly population -~     a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to~     evaluate the effect of an anticholinergic medication on cognitive function in elderly women.~   "
86734|NCT01922102|"~     This study is designed to evaluate the efficacy and safety of two different dosing regimens~     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in~     patients with visual impairment due to choroidal neovascularization secondary to pathologic~     myopia (PM)~   "
86735|NCT01922089|"~     The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in~     heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching~     target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration~     regimens.~   "
86736|NCT01922076|"~     This phase I trial studies the side effects and the best dose of WEE1 inhibitor AZD1775 when~     given together with local radiation therapy in treating patients with newly diagnosed~     diffuse intrinsic pontine gliomas. WEE1 inhibitor AZD1775 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy~     x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink~     tumors. Giving WEE1 inhibitor AZD1775 with local radiation therapy may work better than~     local radiation therapy alone in treating diffuse intrinsic pontine gliomas.~   "
86737|NCT01922063|"~     Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained~     from survivors of disc surgery that would have considered the type of postoperative care.~      Objectives: 1) To evaluate the long-term effects of postoperative comprehensive~     physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of~     segmental instability in the operated segment 12 years following lumbar disc surgery.~   "
86738|NCT01922050|"~     Part 1:~      To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once~     daily treatment for two consecutive days~      Part 2:~      To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily~     treatment for two consecutive days compared to vehicle formulations~   "
86739|NCT01922037|"~     This multicenter, prospective study will evaluate the correlation of participant's~     characteristics, including biomarkers, with predictive markers of clinical outcome in~     participants with moderate to severe asthma initiating treatment with omalizumab. During the~     48 weeks, participants will be evaluated and treated per investigator discretion and will be~     followed from study entry until a maximum follow-up of 48 weeks, death, withdrawal of~     consent, loss to follow-up, or study closure.~   "
86740|NCT01922024|"~     The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21~     microorganisms and 19 genes associated with antibiotic resistance in 4 hours.~      In this study, the performance of the Unyvero LRT55 Application shall be tested under~     clinical conditions and compared to (1) a composite reference method (for non-atypical or~     cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical~     microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii,~     and for resistance genes.~      PCR amplifications are followed by bi-directional sequencing, including comparison of the~     test results Time to result will be compared for the Unyvero LRT55 Application and~     standard-of care.~   "
86741|NCT01922011|"~     The purpose of the study is to determine whether daptomycin is effective and safe in the~     treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or~     nafcillin (or β-lactam equivalent).~   "
86742|NCT01921998|"~     Side effects from chemotherapy can be severe in some patients leading to admission to~     hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood~     test that could predict patients who will go on to develop severe side effects could be~     useful and might allow early intervention with medicines to reduce the severity of the~     symptoms and prevent admission to hospital.~      This study will collect blood samples from patients with lymphoma or sarcoma who are~     receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the~     side effects that most commonly results in hospital admission, of less than 20%). It will~     assess whether changes in blood proteins (biomarkers) taken 2 days after the 1st~     chemotherapy can predict subsequent severe side effects throughout the 4 months of~     chemotherapy. In addition the investigators will collect data on quality of life and contact~     with medical professionals to assess the costs of chemotherapy toxicity to both the patient~     and health service. This will allow us in the future to model the cost effectiveness of~     using biomarkers in this manner to try and reduce chemotherapy toxicity.~   "
86743|NCT01921985|"~     This study investigates if the administration of terlipressin reduces complications after~     major liver surgery.~   "
86744|NCT01921972|"~     This is a national multicenter, double-blind, randomized, parallel-group trial of 12 months~     in duration. Following a 4 week wash-out period, subjects will be randomized to one of 2~     treatment groups: (1) galantamine CR 24 mg/day with dose-titration over twelve~     weeks[maintenance phase from week 9], (2) a combination of galantamine CR 24 mg/day plus~     memantine 10 mg b.i.d. with a dose titration of sixteen weeks (12 weeks for galantamine~     [maintenance phase from week 9], additional 4 weeks for memantine).~   "
86745|NCT01921959|"~     The purpose of this ancillary study is to determine whether a behavioral weight loss~     intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive~     ripple effect on weight and health of partners and children/offspring.~   "
86746|NCT01921946|"~     A phase Ⅰ study to evaluate the pharmacokinetic interactions and safety between fimasartan~     and rosuvastatin in healthy male volunteers.~   "
86747|NCT01921933|"~     The objective of this study is to assess the performance and safety of the Optiflow~     Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous~     arteriovenous fistula (AVF) anastomoses.~   "
86748|NCT01921920|"~     This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose~     Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules~     Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules~     Manufactured by Merck~   "
86749|NCT01921907|"~     A topical treatment applied twice daily for 4 weeks to induce disappearance of facial~     actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated~     as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be~     treated by the active component.~   "
86750|NCT01921894|"~     This study of vitamin D is designed to assess both the safety and efficacy of potential~     doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a~     short period of time (e.g. 4 weeks or less) compared to 200 IU/day.~      In children with vitamin D insufficiency or deficiency who are at risk for severe asthma~     exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and~     2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000~     IU/day) will result in a larger proportion of subjects achieving this level within 4 weeks.~   "
86751|NCT01921881|"~     The goal of the study is to examine if healthy individuals that ingest St John's wort will~     have a significantly difference in glucose tolerance.~   "
86753|NCT01921855|"~     This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with~     moderate or severe congenital hemophilia A or B with or without inhibitors. This is a~     randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is~     designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic~     and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses~     to be examined in subsequent studies.~   "
86754|NCT01921842|"~     The study is an evaluation of a nutrition and physical activity intervention in child care~     centers in NC, CA, and CT.~   "
86755|NCT01921829|"~     This research study is a randomized clinical trial to evaluate if taking diuretics~     (medications that increase urine production and help with fluid removal from the body) in a~     standardized fashion (using a guideline for adjusting doses based on measured urine output)~     could improve health outcomes in patients with cardiorenal failure or cardiorenal syndrome~     (combined heart and kidney failure) with edema (too much fluid in their arms, legs, and/or~     lungs). Under usual care, these patients are treated with diuretics and other medications in~     increasing doses, but not necessarily to maintain a specific amount of urine output per day.~     Current heart failure (HF) treatment guidelines do not provide any standard protocol, or~     guideline, for adjusting diuretic doses. At the point when kidney function worsens to the~     degree that the kidneys are no longer able to respond to the medications used to remove~     fluid, either ultrafiltration (UF) or dialysis (also called hemodialysis [HD]) is typically~     started in order to remove fluid. In both UF and dialysis, excess fluid is removed from the~     body by using a machine. In dialysis, both waste products and fluid are removed and~     electrolyte abnormalities are corrected. In UF, only fluid is removed. Both procedures use~     the same machine. This study will test whether a Protocolized Diuretic Strategy (ProDiuS), a~     plan for adjusting diuretic doses based on measured urine output, will improve clinical care~     for cardiorenal syndrome. Such a plan for adjusting diuretic doses is needed to improve~     symptoms, decrease the length of hospital stays and rehospitalization rates, and improve~     health-related quality of life (HRQOL) in cardiorenal syndrome patients.~   "
86756|NCT01921816|"~     The investigators aim to examine the efficacy and safety of using a new citrate containing~     commercially available solutions (Prismocitrate 18/0) as the regional citrate~     anticoagulation in continuous renal replacement therapy for critically ill patients.~   "
86757|NCT01921803|"~     External beam radiotherapy (RT) is one of the standard curative treatment options for~     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term~     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of~     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.~     The sensitivity of different tissues to fractionation changes can be quantified through the~     α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with~     both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC~     is lower than for most other tumors and approaches a value characteristic of late responding~     tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is~     indeed low, then hypofractionating RT treatments can theoretically maintain high~     bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The~     advantages in terms of patient convenience and treatment cost are obvious. There is level I~     evidence that shows that hypofractionated radiotherapy schedules have at least equivalent~     biochemical outcome with only a small increase in acute but not late toxicity when compared~     to conventional fractionation RT schedules.~      Results on different hypofractionation schedules have been reported, however the optimal~     hypofractionation is not clear so far. In this randomised trial we would like to compare 2~     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25~     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late~     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be~     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size~     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse~     bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern~     design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72~     patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or~     worse GI complications, then the study arm was to be rejected. To allow for a dropout of~     10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated~     analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse~     GI complications with an expected rate of 25%. When including 155 patients per group (310 in~     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients~     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The~     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%~     allowance for dropout.~   "
86758|NCT01921790|"~     The purpose of this study is to evaluate the efficacy and safety of avastin combined with~     gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line~     treatment in patients with untreated natural killer(NK)/T cell lymphoma~   "
86759|NCT01921777|"~     To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and~     inflammatory immune response over a period of 72 hours after a second bout of strenuous~     concentric exercise on bicycle (exercise #2).~   "
86760|NCT01921764|"~     The prevalence and consequences of musculoskeletal pain is considerable among healthcare~     workers, allegedly due to high physical work demands of healthcare work. Previous studies~     have shown promising results of physical exercise for relieving pain among different~     occupational groups, but the question remains whether such physical exercise should be~     performed at the workplace or in the private sphere at home. Performing physical exercise at~     the workplace together with colleagues may be more motivating for some employees and thus~     increase compliance. On the other hand, physical exercise at the workplace may be costly for~     the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy~     of workplace- versus home-based training on musculoskeletal pain. This study investigates~     the effect of workplace-based versus home-based physical exercise on musculoskeletal pain~     among healthcare workers.~      The main hypothesis is that physical exercise at the workplace for 10 weeks compared with~     physical exercise at home results in reduced musculoskeletal pain among healthcare workers.~   "
86761|NCT01921751|"~     This randomized phase II trial studies how well high or standard intensity radiochemotherapy~     after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation~     (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in~     treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing or by stopping them from spreading. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to~     radiation therapy. Giving radiation therapy in different ways and adding chemotherapy may~     kill more tumor cells. It is not yet known whether high intensity radiochemotherapy after~     gemcitabine hydrochloride and nab-paclitaxel is more effective than standard intensity~     radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel or gemcitabine~     hydrochloride and nab-paclitaxel alone in treating pancreatic cancer.~   "
86763|NCT01921725|"~     The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical~     Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound~     healing effects of activated-carbon-fiber-based wound dressing on different types of~     wounds.The dressing is composed by three layers. The first layer is a material of~     polyethylene terephthalate (PET) weave which is great breathable; Second layer, the~     activated carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and~     contaminations. It reduces the smell of wound and restrains the development of bacteria. In~     addition, activated carbon has features of far-infrared and anion, which promote blood~     circulation, speed up metabolism and shorten the time of wound healing. The third layer is a~     polyethlene (PE) film, which touches the wound surface and provides the anti-adhesion~     effects.~      The aim of this study is to investigate how the application of the dressing affects the~     wound healing conditions on four different types of wounds, including general traumatic~     wounds, elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the~     characteristics of great fluid absorption and far-infrared features, the hydrophilic-based~     dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair~     conditions.~   "
86764|NCT01921712|"~     The purpose of this study is to assess the safety and tolerability of PUR0200. In addition,~     the study will look at the blood levels of different doses of PUR0200 and their affect on~     lung function in COPD patients.~   "
86765|NCT01921699|"~     Macrophages are derived from monocytes recruited to the tumor site and stimulated by~     specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have~     been postulated as being involved in the progression of cancer.~      Based on our preliminary findings and on published data we hypothesized that~     macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells~     during chemotherapy.~      The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of~     Pancreatic ductal adenocarcinoma (PDA).~      methods:~        1. The human PDA cell line Panc1 will be grown in suitable conditions.~        2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy~          donors in medium with M-CSF for 7 days.~        3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning~          medium (TCCM) of PDA Cells for an additional 72 hours.~        4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to~          macrophages CM.~        5. Cell proliferation will be quantified by light microscopy and by an XTT Cell~          Proliferation Assay Kit.~   "
86766|NCT01921686|"~     The purpose of this project is to learn more about a new and promising way to diagnose acid~     reflux disease using a very high-powered microscope. This special microscope provides much~     finer detail than typical microscopes previously used for diagnosing reflux, and may help~     doctors to better identify children with acid reflux.~   "
86767|NCT01921673|"~     Docetaxel is currently one of standard second-line therapy in patients with gastric cancer.~     As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer,~     dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of~     patients with gastric cancer. Therefore, we investigated the combination regimen of~     docetaxel and dovitinib.~   "
86768|NCT01920620|"~     In this study we sought to determine whether inpatient weight loss counseling with post~     discharge phone follow-up would result in weight loss at six months. Secondary endpoints~     included weight change from baseline, changes in waist-to-hip ratios, assessment of weight~     perceptions and changes in patient reported health outcome measures. To our knowledge, this~     is the first randomized trial designed to evaluate the effects of an obesity intervention~     with post-discharge follow-up in an inpatient general medicine population.~   "
86769|NCT01920607|"~     The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence~     (defined as more than a major leak per week). The hypothesis of this non-inferiority trial~     is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective~     in managing fecal incontinence~   "
86770|NCT01920594|"~     This study will test the hypothesis that GSK1278863 will reduce neurologic, renal, and/or~     cardiac ischemia in patients undergoing elective descending thoracic aorta/thoracoabdominal~     aortic aneurysm (DTA/TAAA) repair, a population known to be at high risk for ischemic events~     from their underlying pathology and the surgical complexity required to address their~     disease. Approximately 160 subjects will be stratified according to intervention type~     (surgical or endovascular repair, with the latter limited to 50% of the total study~     population) and randomized in a 1:1 fashion to treatment with GSK1278863 (300 milligrams~     [loading dose] followed by 100 milligrams [mg]/day x 4 days) or placebo starting prior to~     planned repair, through postoperative day 3. The duration of participation in this study is~     expected to be approximately 4 to 8 weeks from screening to follow-up.~   "
86771|NCT01920581|"~     The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and~     zopiclone) usage in an outpatient population of chronic users over 65 years in France using~     a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and~     Statistical Manual of mental disorders) international standards.~   "
86772|NCT01920568|"~     This is a randomized, double-blind, double-dummy study designed to provide bridging data in~     an Asian population to Amgen's studies of denosumab in subjects with bone metastases from~     solid tumors. The study is designed to provide data to a large global dataset of phase-III~     studies including breast cancer, prostate cancer, and all solid tumors, plus multiple~     myeloma, to support the regulatory approval for marketing and patient access to denosumab~     for the prevention of SREs in Chinese subjects with bone metastases from solid tumors. The~     primary objective of this study is to evaluate and compare the percent change from baseline~     to Week 13 in the bone marker urinary amino-terminal cross-linking telopeptide of type I~     collagen (uNTx) corrected for urine creatinine (uNTx/uCr) in subjects treated with denosumab~     to those treated with zoledronic acid. The study is designed to test the superiority of~     denosumab over zoledronic acid.~   "
86773|NCT01920555|"~     This study is looking at the efficacy, durability, safety, and tolerability of multiple~     single doses of Ketamine vs. active placebo for treating patients with treatment resistant~     depression who are taking an antidepressant that is not working for them.~   "
86774|NCT01920542|"~     we hypothized dexmedetomidine could reduce the reduction of renal function after~     cardiopulmonary bypass weaning in pediatric patients~   "
86775|NCT01920529|"~     Regular aerobic physical activity in short-term moderate asthma and severe:~        -  Reduce the levels of inflammatory mediators~        -  Improves functional capacity~        -  Improves Quality of Life~        -  Improved lung function~        -  Reduces the sensation of dyspnea~        -  Improves symptoms scores and medication use~   "
86776|NCT01920516|"~     In-transit metastases occur in approximately 3% of melanoma patients, can be very~     symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases~     are often confined to a limb. In this circumstance, treatment by isolated limb perfusion or~     isolated limb infusion can be a remarkably effective regional treatment option. Isolated~     limb infusion (ILI) was introduced in 1992 and is a technique used to deliver regional~     chemotherapy to treat advanced melanoma confined to a limb. Regional chemotherapy with~     melphalan delivered by isolated limb perfusion (ILP) or ILI are effective treatment options~     for in-transit melanoma and are generally well tolerated.~      ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69%~     for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared~     to ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of~     these parameters potentially having an effect on outcome. ILP & ILI are used primarily as~     palliative options when excision of in-transit metastases is unfeasible but can be used as~     an adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma,~     and can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight~     has been shown to substantially decrease the rates of severe local toxicity while~     maintaining complete response rates, but overall response rate is reduced.~      Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs~     disease is associated with similar complete response rates but lower toxicity than ILI for~     Lower limbs E disease and with different physiologic sequelae despite comparable methods.~     The Upper limbs appears relatively resistant to toxic effects of melphalan-based ILI as~     currently performed, which suggests a potential for further optimization of drug dosing for~     Upper limbs ILI.~      Regional therapy is an excellent therapeutic modality for disease limited to a limb and~     furthermore serves as an excellent model for scientific investigation, both clinical and~     translational. In this study we want to collect data on isolated limb infusion of~     chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of~     the arm or leg that cannot be removed by surgery.~   "
86777|NCT01921647|"~     The objective of this study is not only to explore pharmacokinetic interaction after single~     oral administration but also pharmacodynamics interaction after multiple oral administration~     of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808,~     amoxicillin and clarithromycin in healthy volunteers~   "
86778|NCT01921634|"~     There is great variation seen in the incidence of appendiceal endometriosis. The variation~     is most likely multifactorial, but method with which the specimen is examined may play a~     role. If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a~     higher rate.~   "
86779|NCT01921621|"~     This study examines in a prospective, randomized and blinded study design the impact of a~     proficiency based training methodology on the acquisition of arthroscopic surgical skills~     employing both a dry shoulder simulator model, and cadaver specimens for the demonstration~     of surgical skill proficiency.~   "
86780|NCT01921608|"~     It is well known from a range of observational and epidemiological studies that the lifetime~     risk of acquiring HIV among males can be significantly reduced via circumcision. Numerous~     papers on the topic were published in the past two decades to elevate HIV prevention~     awareness, especially in sub-Saharan countries.~      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men~     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the~     government is continuing to study the PrePex™ device, developed to enable rapid adult male~     circumcision in resource limited settings.~      In February 2012, Rwanda has received WHO recommendation to scale up Adult Male male~     circumcision (MC) using the PrePex device. Based on WHO recommendation (Use of devices for~     adult male circumcision in public health HIV prevention programs: Conclusions of the~     Technical Advisory Group on Innovations in Male Circumcision, March 2012, WHO/HIV/2012.7),~     which recommended that the phased implementation include an active surveillance of the first~     1000 clients to identify and record all adverse events and side-effects based on~     standardized definitions. The active surveillance may change to passive surveillance after~     the first 1000 clients, if the incidence of events is reassuringly low, as determined by~     independent review.~   "
86781|NCT01921595|"~     The purpose of study is to compare the effect of coagulation profile in patients receiving~     intraoperative balanced salt colloid undergoing spinal cord tumor surgery.~   "
86782|NCT01921582|"~     The purpose of this study is to determine whether methylphenidate is effective in the~     treatment of binge eating disorder, in a randomized controlled trial extended release~     methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight~     or obese adult females.~   "
86783|NCT01921569|"~     The purpose of this study is to determine whether micronized dehydrated human amniotic~     membrane (dHACM) suspension is more effective in reducing inflammation than conservative~     measures alone when used to treat acute/early lateral epicondylitis.~   "
86784|NCT01921556|"~     Background The Swiss health ministry launched a national quality program QualiCCare in~     2011 to improve healthcare for patients with COPD.~      The aim of this study is to determine whether participation in the COPD quality initiative~     (QualiCCare) improves adherence to recommended clinical processes and shows impact on~     patients COPD care and on quality of life in patients with COPD.~   "
86785|NCT01921543|"~     The main aim of this trial was to investigate whether patients suffering from treatment~     refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in~     the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus~     of the stria terminalis (CI/BNST)~   "
86786|NCT01921530|"~     Degenerative spondylolisthesis describes the slip of one spinal segment relative to the~     adjacent segment. It is usually associated with spinal stenosis (which limits one's ability~     to walk and stand) and is the most common indication for surgery in adults over age 65~     years. A variety of surgical techniques are available; the most common are the~     Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral~     Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is~     placed within the cleaned out disc space between the vertebral bodies being fused. Although~     this approach achieves a good fusion rate and deformity correction it is associated with a~     higher surgical cost and potential intra-operative complication rate. What is more, no~     consensus exists as to whether IF provides better patient rated functional outcome and~     quality of life. If the advantages of IF do not translate into superior patient rated~     outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this~     study is to determine if IF is equivalent to PLF for the treatment of degenerative~     spondylolisthesis. The investigators will conduct a prospective randomized control trial~     comparing these two procedures. Our primary outcome measure will be the Oswestry Disability~     Index, which evaluates spinal pain and function.~   "
86787|NCT01921517|"~     The response to a daily 10 minute session of low-magnitude mechanical stimulation (LMMS) on~     bone in 100 postmenopausal women ages 45-65 years will be evaluated at baseline and 12~     months using high-resolution magnetic resonance (MR) imaging. Subjects will be assigned to~     an active platform that produces vibrations or to a placebo platform that produces no~     vibrations.~      The investigators propose to evaluate the hypothesis that LMMS applied to postmenopausal~     women ages 45-65 improves the mechanical integrity of bone while lowering marrow adiposity.~        1. The investigators will optimize an integrated imaging protocol for high-resolution~          structural MR imaging of the distal tibia and spectroscopic imaging-based~          quantification of bone marrow composition in the lumbar vertebrae.~        2. The investigators will further develop and validate micro-finite-element (FE) analysis~          for quantitative assessment of trabecular and cortical bone stiffness and failure load~          from high-resolution MR images of the distal tibia.~        3. The investigators will apply the methodology of Aims 1 and 2 (above) in a~          double-blinded, randomized, placebo-controlled study to a cohort of 100 healthy~          postmenopausal women in the age range of 45-65 years, studied at baseline and 12 months~          after having been subjected to 10 minutes daily of either 30 Hz/0.3g stimulation or~          placebo treatment, monitored rigorously via electronic feedback.~   "
86788|NCT01921504|"~     The aim of the study is to investigate the effect of acupuncture treatment on functional~     dyspepsia.~   "
86789|NCT01921491|"~     The purpose of this study is to determine whether dehydrated human amnion/chorion membrane~     (dHACM) is more effective than another commercially available product or conservative~     measures alone when used to treat diabetic foot ulcers (DFUs).~   "
86790|NCT01921478|"~     This retrospective, multi-centre, observational study will assess the daily practice~     patterns and outcomes of the management of rheumatoid arthritis in patients treated with~     RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will~     be collected from medical records.~   "
86791|NCT01921465|"~     The purpose of the study is to evaluate whether outpatient cesarean section can be performed~     in multiparous women without significant decrease in the parents' sense of security .~   "
86792|NCT01921452|"~     This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled~     subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and~     the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at~     the same time.~   "
86793|NCT01921439|"~     The long-term goal is to improve the quality of life of children and their parents who smoke~     tobacco by facilitating parental smoking cessation in a way that is easy to administer yet~     effective. We aim to accomplish this goal by administering an interactive computer-based~     program that will facilitate motivation and readiness to engage in smoking cessation by~     providing personalized feedback about the financial and health effects of the parent's~     smoking. We will compare the changes in motivation and readiness to quit smoking after the~     parent has taken the computer-based program and compare them to the changes in motivation~     and readiness to quit in parents who receive only information about the Oklahoma Tobacco~     Helpline. We will also measure salivary cotinine levels in both parents and children, to~     objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis~     is that our computer-based program will cause a greater increase in motivation and~     confidence to quit smoking in the group that receives the customized feedback than the group~     that receives only information about the Tobacco Helpline. We also predict that both parent~     and child cotinine levels will show a greater decrease in the group randomized to receive~     personalized feedback.~   "
86794|NCT01921426|"~     The purpose of this study is to determine the safety, tolerability, and the highest dose of~     GC4419 that can be given to patients with squamous cell cancer of the head and neck who are~     receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419~     for the following:~        -  Effect on the incidence and severity of radiation induced oral mucositis;~        -  Effect on the response rate of squamous cell cancer of the head and neck who are~          receiving radiation therapy and chemotherapy;~        -  Total concentrations of GC4419 that can be achieved in the blood;~        -  Changes in proteins and genetics associated with oral mucositis;~        -  Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open~          the mouth);~        -  Observe changes in genetic and molecular markers of oral mucositis;~        -  Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube~          use, etc.) of study patients;~        -  Assess the overall quality of life in study patients with oral mucositis.~   "
86795|NCT01921413|"~     The purpose of this study is to evaluate the clinical performance of the one-step Fyodor~     Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the~     diagnosis of Plasmodium falciparum malaria in febrile patients. A total of 1500 properly~     consented children and adults presenting with fever (axillary temperature ≥37.5°C) or~     history of fever in the last 48 hours (Group 1), 250 apparently healthy individuals~     (Control, Group 2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis~     (Group 3), will be recruited. Matched urine and fingerprick (capillary) blood samples will~     be collected and tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood~     test) and thick smear microscopy, respectively. The overall agreement of the UMT results to~     the Binax NOW analysis and thick smear microscopy will be used to establish UMT sensitivity~     and specificity.~   "
86796|NCT01921400|"~     To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal~     membranes using paraffin-embedded sections and post-delivery specimens respectively. In~     parallel, we will assess placental tissue for evidence of HCV infection using a novel in~     situ hybridization technique and translate our in vitro findings to these in vivo samples.~      Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the~     placenta serve as a barrier that must be crossed during vertical transmission and that~     cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain~     conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV~     in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV~     regulation should be revealed.~      Based on our preliminary data, our working hypothesis is that HCV Core protein is~     differentially processed in cytotrophoblasts compared to hepatocytes.~   "
86797|NCT01921387|"~     This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal~     antibody when given together with combination chemotherapy before stem cell transplant and~     to see how well it works in treating patients with high-risk lymphoid malignancies.~     Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8,~     can find cancer cells and carry cancer-killing substances to them without harming normal~     cells. Giving chemotherapy before a stem transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. Stem cells collected from the patient's blood~     are then returned to the patient to replace the blood-forming cells that were destroyed by~     the radiolabeled monoclonal antibody and chemotherapy.~   "
86798|NCT01921374|"~     The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male~     newborns. During its progression there is loss of mobility, swallowing difficulties and a~     significant reduction in respiratory capacity. Due to the severity and consequences, is~     inevitable the need for a caregiver, that normally rely the mother.~   "
86799|NCT01921361|"~     The purpose of this study to compare the efficacy of intravenous or intrathecal~     dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia~     for elective surgery.~   "
86800|NCT01921348|"~     We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis~     by changing the immune parameters and the psychological impact factors are associated with~     ear acupressure treatment outcome.~   "
86801|NCT01921335|"~     The purpose of this study is to test the safety of different doses of ARRY-380 in~     combination with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2~     metastatic breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet~     been tested. Both agents block the HER2 receptor, which is thought to be overactive in~     HER2-positive breast cancer. It is thought that ARRY-380 and trastuzumab might work together~     because they attach to different parts of the HER2 receptor and prevent it from functioning.~     Because HER2 positive breast cancer contains high levels of HER2 receptor, but normal cells~     in your body generally do not, the drugs may be able to target the cancer cells. In~     addition, in laboratory studies, ARRY-380 appears to have some penetration into the brain.~   "
86802|NCT01921322|"~     This is a prospective, randomized (open label), multi-center and post-market study. The~     study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple~     daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes~     in China~   "
86803|NCT01921309|"~     To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic~     Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared~     for use in the U.S. The comparison will be based upon clinical success at the Month 24~     endpoint.~   "
86804|NCT01921296|"~     Many women with breast cancer who are treated with aromatase inhibitor medications develop~     difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor~     medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).~     Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine~     (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also~     improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study~     we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated~     with aromatase inhibitors.~   "
86805|NCT01921283|"~     There are clinical usefulness issues associated with bispectral index (BIS) for sedation of~     endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep~     sedation is incompletely described. The purpose of this study is to show that BIS-guided~     sedation is safe and useful clinically and may provide stable sedation status to physicians~     and patients.~   "
86806|NCT01921270|"~     The purpose of this study is to study the efficacy, safety, and proper dosing of~     AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD). The study hypothesis~     is that one of the dosing levels used will have adequate safety and efficacy.~   "
86807|NCT01921257|"~     Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects~   "
86808|NCT01921244|"~     Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that~     may be improved with pharmacotherapy, including difficulties with sleep, attention,~     hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings,~     self-injury, and aggression. While 34-58% of children with ASD take medication for such~     behaviors, there is wide practice variation nationally and a lack of evidence to support the~     use of most commonly prescribed agents. Complex clinical situations such as this where there~     is no clear best choice regarding which behaviors to target and which medications to use~     lend themselves well to the use of a Shared Decision Making (SDM) tool to ensure that~     well-informed parent preferences shape every treatment plan.~      The primary goal of this study is to modify a previously published decision aid about use of~     medication to manage challenging behaviors in children with autism to make it easy to~     implement in practice and then evaluate this version in terms of proximal decisional~     outcomes and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral~     Pediatric clinic will be enrolled and randomly allocated to intervention or control~     (treatment as usual) groups. Initially, providers randomized to the intervention group will~     test and refine the modified intervention. Once the intervention is finalized, eligible~     patients of participating providers will be enrolled in the randomized controlled trial to~     test the efficacy of the intervention. Following the trial, control group providers will be~     crossed over and receive the intervention. Both proximal decisional outcomes (e.g. parent~     decisional conflict, provider amount of SDM, parent knowledge of treatment options) and~     outcomes 3 months later (e.g. parenting stress, decisional conflict, and change in child~     behavioral symptoms) will be assessed.~      Approximately 10 providers and 240 of their patients with autism will be included in the~     study. Chart reviews, parental surveys, and recordings of provider-parent-patient~     interactions during the index visit will be collected at baseline (prior to physician~     allocation), during the intervention trial, and after the control group has crossed over.~     Between- and within-group analyses will examine factors associated with parental decisional~     conflict and whether the intervention produces significant improvements in outcomes over and~     above typical autism care. Analyses will include multiple linear regression modeling and~     general linear models / repeated measure models, accounting for data clustered by provider.~   "
86809|NCT01921231|"~     Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal~     anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective.~     Lidocaine has been the well-known choice for this procedure. However, it is associated to~     transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have~     been performed, for example, the use of small doses of long-acting agents and the use of~     additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk~     of transient neurologic symptoms. We design and plan a randomised clinical trial to show if~     hyperbaric prilocaine 2% would be an alternative.~   "
86883|NCT01920152|"~     The objective of this study is to compare the clinical efficacy of intra-articular~     injections of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic~     early osteoarthritis (OA) of the hip. Secondarily, this study aims to determine the~     feasibility and safety of treating early OA of the hip with HA and PRP.~   "
86810|NCT01921218|"~     The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®)~     in preventing antibody formation in patients with chronic failing kidney transplants. This~     study is a randomized study of first-time kidney transplant patients who have worsening~     kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy~     (IF/TA). Patients must be eligible to get a second transplant. They must have completed or~     be actively undergoing evaluation for re-listing for a second transplant. Patients will be~     randomized to either convert to belatacept or continue on calcineurin inhibitor-based~     therapy.~   "
86811|NCT01921205|"~     Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other~     Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently~     have uncontrolled partial onset seizures.~   "
86812|NCT01921192|"~     Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated~     with extracellular matrix changes. Many studies demonstrated that high levels of this~     aminoacid in diabetic patients increases significantly the risk of the development of this~     pathology. This study has been undertaken to investigate the role of homocysteine and its~     cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic~     retinopathy.~   "
86813|NCT01921179|"~     One of the most pressing concerns within the VA currently is the provision of interventions~     that address the cognitive as well as emotional problems faced by Veterans with concurrent~     mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain~     injury influences how people think, act, and feel. This may include how people pay~     attention, keep information in memory, organize plans for achieving important goals, and~     manage stress. Another purpose of this research is to learn more about the effects of~     cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild~     brain injury - both in the short- and long-term. With this research, the investigators hope~     to better understand and treat cognitive and emotional difficulties that can occur due to~     PTSD and mild brain injury.~   "
86814|NCT01921166|"~     The purpose of the study is (A) to determine if the following novel approach improves the~     live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to~     diminished ovarian reserve:~        -  ovarian stimulation with medications that are effective in women with diminished~          ovarian reserve but adversely affect the endometrium~        -  oocyte retrieval and vitrification~        -  fertilization and embryo transfer in a subsequent cycle with controlled endometrial~          preparation B) To determine the optimal stimulation protocol for women with diminished~          ovarian reserve incorporating oocyte vitrification~      Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted~     Reproductive Therapy program because of an extremely poor prognosis will be recruited for a~     prospective, randomized, open-label study to determine if a novel approach improves the live~     birth rate with traditional IVF poor prognosis stimulation protocols. The novel approach~     will incorporate one of two protocols utilizing medications that provide maximal ovarian~     stimulation but have a temporary detrimental fertility-reducing effect on the endometrium.~     If ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes~     vitrified (stored in a glass-like state in liquid nitrogen). At a later time, oocyte~     warming and fertilization will be performed in a subsequent cycle, in which the endometrium~     has been prepared.~      Key points include:~        -  Randomization to one of two ovarian stimulation protocols that have been shown to have~          a detrimental effect on the endometrium, and therefore are rarely used in a fresh IVF~          cycle~        -  Oocyte vitrification is considered to be an investigational procedure by the American~          Society of Reproductive Medicine (ASRM), and should only be performed under the~          supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte~          retrieval can unlinked from embryo transfer, allowing embryo transfer to occur in a~          more optimal environment~        -  Endometrial preparation is routine for frozen embryo transfer~   "
86815|NCT01921153|"~     The primary objective of this study is to test effectiveness of an environmental~     intervention designed to encourage healthy food intake during meals. It is hypothesized that~     fruit, vegetable, whole grain, lean protein, and low-fat dairy consumption will increase~     during the intervention. It is also hypothesized that nutrition knowledge, attitudes, and~     behaviors will change as a result of the intervention. The findings from this study will~     provide insight into the applicability of this intervention in military dining facilities.~   "
86816|NCT01921140|"~     This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure~     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after~     eating and the effect of olaparib on QT interval following a single oral dose of olaparib~     tablets. Part B will determine the effect of olaparib on the QT interval following multiple~     oral dosing. Part C will allow patients continued access to olaparib tablets and will~     provide additional safety data collection.~   "
86817|NCT01921127|"~     This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD~     patients new to ICS/LABA combination therapy.~   "
86818|NCT01921114|"~     The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally~     Inserted Central Catheter (PICC) is associated with less formation of blood clots compared~     to another commercially available PICC.~   "
86819|NCT01921101|"~     The investigators propose a prospective randomized clinical trail to evaluate the impact of~     intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress~     syndrome (ARDS) or acute lung injury (ALI) on short and long-term outcomes. Participant's (N~     = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of~     standard food) or IMNT provided early as enteral nutrition (EN) and continued as intensive~     diet therapy tailored to maximize oral intake until hospital discharge. Primary outcomes~     evaluated include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum~     IL-10 and leptin levels, numbers of T regulatory cells and markers for T cell anergy), days~     on mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured~     by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip~     strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.~   "
86820|NCT01921088|"~     The purpose of this study is to determine the potential efficacy of real-time functional~     magnetic resonance imaging neurofeedback (RT-fMRI-NF) in regulating brain activity and~     psychophysiological functions.~   "
86821|NCT01921075|"~     The main goal of the present study was to provide a technical basis for future studies~     assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS)~     techniques will be used in this study to:~        1. assess the methodological reproducibility of MRS-measurements of cardiac lipids in~          humans~        2. investigate physiological variations of cardiac lipids by measuring day-to-day changes~          under identical conditions~        3. determining diurnal variations of cardiac lipids in humans~   "
86822|NCT01921062|"~     The aim of this study is to determine whether motor imagery training during the~     immobilisation period in patients with a distal radius fracture, results in an improved~     functional outcome compared to patients who do not perform motor imagery.~   "
86823|NCT01921049|"~     Patients undergoing major procedures in oral and maxillofacial surgery more often develop a~     systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical~     care therapy than patients with a comparable major surgery in other regions. The reasons for~     this finding are unknown and have not been studied in depth so far. We hypothesize that~     surgical trauma in this region might activate pro-inflammatory pathways. By examining the~     proteome of patients at different stages (prior to the surgery, at ICU admission, on the~     second postoperative day and when SIRS has ended clinically), we aim to identify the~     involved pro-inflammatory pathways and identify possible target proteins that might be clues~     to modification of postoperative SIRS in the future.~   "
86824|NCT01921036|"~     Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt~     per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN)~     group or usual care (UC). The IN patients will perform supervised endurance and resistance~     exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation~     (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is~     planned for six months with a follow-up of a further six months. The primary investigation~     is differences between IN and UC with regard to changes in exercise capacity (max~     watt/kgBW).~   "
86825|NCT01921023|"~     This clinical investigation is being undertaken to examine the performance of the CE marked~     Proxima System - a patient attached blood gas analyser.~      The study forms an element of the Post Market surveillance plan for the Proxima system and~     will also generate method comparison data to allow Sphere Medical to submit the Proxima for~     FDA regulatory clearance.~   "
86826|NCT01921010|"~     The combination of HDL-C elevation, lowering of triglcerides and further LDL-C reduction~     accomplished by the addition of niacin to statin medication would improve endothelial~     function as compared to LDL-C reduction alone in patients with and without coronary artery~     disease and the combination of low HDL-C/high triglycerides.~      The combination of lipid lowering therapy would have beneficial effects on markers of~     inflammation. These benefits would be particularly evident in women.~   "
86827|NCT01920997|"~     This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to~     investigate the expression of their NEI network and urine metabolomics.~   "
86828|NCT01920984|"~     To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in~     patients with PDR. Verifying that it is greater to that found in non-diabetic patients with~     different non-angiogenetic diseases.~   "
86829|NCT01920971|"~     To investigate the effects of short-term and medium-term monochromatic infrared energy~     therapy on patients with chronic low back pain (LBP) according to the International~     Classification of Functioning, Disability and Health.~   "
86830|NCT01920958|"~     The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph~     sealing after lymphadenectomy.~   "
86831|NCT01920945|"~     The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the~     number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a~     benign form of chronic daily headache that comes in two forms: one that resolves on its own~     after months to years, or one that is difficult to treat and does not respond to preventive~     or abortive medications. Some patients experience migrainous features such as nausea,~     vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine,~     will be injected into specific muscles of the head and neck area by your study doctor, to~     evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not~     been approved for NDPH and this is the first time it will be used for treatment of NDPH. All~     participants in this study will only receive BOTOX® and no other study drug.~   "
86832|NCT01920932|"~     This pilot phase II trial studies how well giving brentuximab vedotin, combination~     chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB~     or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer~     growth in different ways. Some block the ability of cancer to grow and spread. Others find~     cancer cells and help kill them or carry cancer killing substances to them. Drugs used in~     chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide,~     and dacarbazine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may~     kill more cancer cells and reduce the need for radiation therapy.~   "
86833|NCT01920919|"~     This trial examines whether low grade suppression of the initial inflammatory process of~     sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant~     alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work~     productivity, and whether this intervention prevents disease progression and reduces total~     health-care costs.~   "
86834|NCT01920906|"~     Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%.~     Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into~     plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is~     still unclear why psoriatic skin lesions start with small macules and then spread~     peripherally.~      To study peripheral spreading of psoriasis, investigators plan to study small plaque~     psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque~     psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis~     participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects~     of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is~     the common or typical form of psoriasis that occurs particularly in Korea and other Asian~     countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is~     widely distributed on the upper trunk and proximal extremities.~      Investigators hypothesize that the expression of immune-related genes are different between~     small and large plaque psoriasis. The study of a genetically homogeneous cohort,~     characterized by the relatively high prevalence of small plaque psoriasis in the Korean~     population, may filter out spurious signals while allowing for significant associations to~     emerge from a relatively low number of participants.~      By comparing small and large plaque psoriasis, it is expected this study could lead to new~     understandings of the mechanisms involved in spreading of psoriatic plaques and provide new~     insights into psoriasis development.~   "
86835|NCT01920893|"~     Primary Objective:~      To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in the treatment of bilateral~     Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score in comparison to~     placebo.~      Secondary Objectives:~      To evaluate effect of dupilumab with regards to:~        -  symptoms of sinusitis~        -  sinus Computed Tomography (CT) scan~        -  nasal polyp score in the sub-group of patients with co-morbid asthma~        -  Safety and tolerability~   "
86836|NCT01920880|"~     Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever~     considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is~     caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior~     Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic~     injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of~     penetration out of the ventral rectus sheet should be considered. This neurectomy however is~     effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory~     ACNES patients suffer from underlying pathologic pain disorders is subject to investigation,~     by using quantitative sensory testing (QST).~      Objective: To investigate nociceptive processing and possible underlying pathological pain~     processing mechanisms in ACNES patients.~      Study design: An observational case-control study.~      Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an~     existing database.~      Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment~     of ACNES for both successfully treated and refractory patients in comparison to healthy~     controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures.~     Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.~      Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST.~     Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.~   "
86837|NCT01920867|"~     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the~     treatment of retinal and optic nerve damage or disease.~   "
86838|NCT01920854|"~     The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of~     intravenously administered Soluble Ferric Pyrophosphate~   "
86839|NCT01920841|"~     The purpose of this study is to evaluate efficacy of two lipolytic creams differing in their~     bases and demonstrate that their herbal ingredients can reduce the size of the thigh and~     smooth the appearance of the thigh skin. It is hypothesized that creams with two different~     cream bases containing herbal products that stimulate the lipolytic process through~     stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily~     5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to~     baseline.~   "
86840|NCT01920828|"~     The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and~     possible changes in gait with enzyme replacement therapy.~   "
86841|NCT01920815|"~     In order to determine the effectiveness of medical therapy options to prevent enlargement of~     the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This~     feasibility study will gather accurate data on number needed to screen, changes in~     medication use over time, and variance of the intended study endpoint.~   "
86842|NCT01920802|"~     The purpose of this pilot randomized clinical trial is to begin to delineate the~     pathophysiological changes associated with antipsychotic associated metabolic side effects.~     The study will be performed in 36 healthy people between the ages of 18 and 30, who have~     never taken an antipsychotic, will undergo baseline laboratory tests before being randomized~     to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The~     primary outcome measure will be a correlation of early changes in leptin with weight gain.~     We will also record changes in food intake, resting metabolic rate, oral glucose tolerance~     and fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be~     followed closely to monitor for safety throughout the 4-week study and will be discontinued~     if there is a medically significant change in metabolic status or other antipsychotic side~     effects. Metabolic assessments will be performed again at the time of discontinuation or at~     the end of an 4-week period, and change from baseline in the two treatment groups will be~     compared.~   "
86843|NCT01920789|"~     A randomized phase II study for medically inoperable stage I non-small cell lung cancer~     where stereotactic body radiotherapy in three fractions to 66 Gy is compared with~     conventionally fractionated radiotherapy to 70 Gy in 35 fractions.~   "
86844|NCT01920776|"~     The investigators hypothesize that lung ultrasound and echocardiography will benefit the~     septic shock patients by making the treatment more precisely and rapidly. Septic shock~     patients from multicenter will be enrolled in the study. They will be randomly divided into~     two groups. The routine treatment group will receive routine treatment according to the SSC~     guideline. The study group will receive additional ultrasound examination, which will decide~     the improvement of therapy. Therapy change based on ultrasound results and the prognosis~     will be recorded.~   "
86845|NCT01920763|"~     This pilot study will examine the safety and the clinical outcomes after minimally invasive~     surgery (using a parafascicular technique guided by diffusion-tensor imaging) for~     intracerebral hemorrhage in patients selected according to evidence-based criteria. The~     investigators will compare 30 day and 90 day outcomes of patients who have surgery to that~     predicted by previously reported models for recovery after ICH, and will also describe any~     surgical complications related to the procedure.~      The investigators hypothesize that this technique will have the same mortality rate and~     function outcome, if not better, when compared to the outcomes predicted by previous models.~   "
86846|NCT01920750|"~     This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the~     immunologically active proteins from the soluble/cytosol and insoluble cell wall of~     Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens,~     equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early~     diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease.~     Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in~     its early stages of infection. With the early administration of drug therapy, infected~     individuals can then be cured of this disease before nerve damage occurs or nodules~     (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative~     volunteers, 18-40 years old, from within the staff of the Mycobacteria Research~     Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado,~     will be selected.~   "
86847|NCT01920737|"~     The purpose of the study is to find out whether the combination of chemotherapy drugs that~     are routinely used in children with ALL, will be safe and effective in treating adult~     patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy~     drugs that are given in different combinations and in several steps. In adult ALL there is~     no standard which drugs to give and how to combine them. Some leukemias have a chromosome~     abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do~     not (called Ph Negative). In this study we want to see whether this combination of~     chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative~     ALL.~   "
86848|NCT01920724|"~     Thailand has been facing with the double burden of malnutrition. Many studies in Thailand,~     which aim to explore the situation, causes, and strategies to prevent obesity, have focused~     on adults, adolescents, or school-aged children. Few studies have been conducted in~     preschool children. Obesity or stunting during childhood increases the risk of being obesity~     in adulthood and leads to chronic diseases. If obesity is established in adulthood, it is~     difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young~     children should be highly considered. Study of dietary pattern and reliable field methods to~     measure fat mass (FM) in children may partly contribute to primary prevention of childhood~     obesity. The deuterium dilution technique is an accurate and suitable method for children~     and population-based studies. However, it has not been widely used in children in Thailand.~     Hence, this study aimed to utilize the deuterium dilution technique for assessing body~     composition and to determine the quality and quantity of dietary intake among children 3-5~     years of age with different nutritional status. We conducted a cross-sectional study in 15~     daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were~     purposively selected according to their nutritional status: stunted, thin, normal, and~     overweight/obese. Anthropometric measurements were conducted. Body composition was~     determined based on total body water using deuterium dilution technique. Dietary intake data~     were obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will~     have more fat mass compared to the normal children.~   "
86849|NCT01920711|"~     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the~     reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF~     with preserved ejection fraction.~   "
86850|NCT01920698|"~     The objective of this trial is to compare the safety, the efficacy and the~     cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone~     versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients~     with severe secondary mitral regurgitation.~      This trial is a French, multicenter and randomized trial. Patients enrolled will be~     clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12~     months and 24 months).~   "
86851|NCT01920685|"~     People with a schizophrenia spectrum diagnosis often experience distressing worries or~     beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs~     are associated with significant distress and disruption to the person's life. This results~     in high use of services and costs to mental health providers.~      The National Institute of Clinical Excellence recommends that cognitive behavioural therapy~     for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The~     latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,~     making it a cost effective intervention.~      Although improved outcomes have been obtained by therapies, CBTp has only small to moderate~     effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is~     intensive, expensive and takes up to a year. CBTp is therefore not widely available to~     service users, resulting in inequalities in access to care.~      The investigators are seeking to improve outcomes and accessibility of CBTp for people with~     distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility~     study of a brief therapeutic intervention, aimed at targeting and improving anxiety~     processes that are causally implicated in paranoia (Freeman et al, 2015).~      The investigators have preliminary evidence indicating that the pilot intervention, with~     interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et~     al, 2015). Participants also reported they found the therapy acceptable, enjoyable and~     useful. Based on these results, the investigators have further modified the intervention.~     The feasibility and efficacy of the therapy will be investigated in a randomised controlled~     design (n = 34).~      Please note the protocol has been been amended to exclude a pilot trial of a second brief~     intervention targeting reasoning styles in paranoia, as since the initial protocol was~     developed we have obtained data from two randomised pilot studies demonstrating its~     feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot~     trial of the reasoning styles intervention is therefore not indicated.~   "
86852|NCT01920672|"~     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and~     irreversible neurodegenerative condition, affecting also close to 15 million family~     caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by~     frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD~     patients is associated with increased rates of neuropsychiatric symptoms, daytime napping,~     'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The~     added strain of sleep disruption is the primary reason family caregivers make the decision~     to institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle~     commonly observed in AD patients occur more often in individuals with hypothalamic/~     pituitary/adrenal (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal~     sleep-wake activity by diminishing an AD patient's ability to respond to external zeitgebers~     which, in turn, can further propagate HPA axis dysfunction. Thus, interventions to normalize~     diurnal HPA axis patterns may be beneficial in treating sleep-wake disturbances.~     Nonpharmacologic treatments are the first line therapy in AD patients with sleep wake~     problems, given the ineffective and potentially harmful effects of pharmacologic agents.~     Current clinical sleep hygiene practices in institutional (e.g., nursing home) settings~     holds promise for reducing disruptive sleep by reestablishing circadian patterns in HPA~     functioning. These interventions include use of timed and planned activities during daylight~     hours and creating a relaxing environment in the evening. However little systematic work has~     been done to determine the efficacy of these interventions in the home setting (where most~     individuals with AD reside).~      We propose a pilot study to (a) characterize objective sleep parameters and behavioral~     symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity~     in a sample of community residing older adults with AD: (b) examine the effects of timed and~     planned activities on subjective and objective characteristics of sleep, behavioral~     symptoms, and HPA status; and (c) evaluate measurement approaches in home-dwelling AD~     patients. Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of~     sleep and behavioral symptoms will be measured in fifty-four AD patients being cared for at~     home by a family. Patients and CG with then be randomized to receive an intervention of~     timed, planned activities (TPA) or attention control (AC) condition. We will also obtain~     diurnal measures of HPA activity including salivary cortisol and alpha amylase.~   "
86873|NCT01920282|"~     Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central~     arterial stiffness and these effects may contribute to improved outcomes in hypertensive~     patients. However, the results of several studies suggest that beta-blockers may actually~     increase arterial stiffness. In contrast, there is limited evidence to suggest that~     nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide,~     reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few~     studies have addressed this issue and all of these studies relied on indirect, blood~     pressure dependent measures of arterial stiffness. In addition, none of these studies~     focused on middle-aged and older, obese hypertensives, a population with accelerated~     arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of~     nebivolol as a therapy to reduce large artery stiffness, particularly among the latter~     population, remains unclear.~   "
86853|NCT01920659|"~     Physical activity is a powerful lifestyle factor that on average reduces risk for~     development of diabetes and cardiovascular disease. Nevertheless, investigators have~     demonstrated that following supervised endurance exercise training, 20% of subjects show no~     change in fitness and 30% demonstrate no improvement in insulin sensitivity.~      Our concept is that by using molecular profiling of blood/muscle samples investigators will~     develop personalised lifestyle intervention tools. Further, revealing the biological basis~     for a variable metabolic or cardiovascular response to exercise will enable us to propose~     new targets and biomarkers for drug discovery efforts directly in humans. Using our~     established OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers~     that predict the responses to exercise-therapy (fitness and insulin sensitivity). Classifier~     generation is a statistical strategy for diagnosis or prognosis. Critically, investigators~     have a large human tissue biobank, including subjects with insulin-resistance; young to~     elderly males and females, as well as twins. Our SME partner has significant intellectual~     property and capacity in the field of bio-prediction, with a proven track-record of~     collaboration with the team and product development. Investigators will add to the diversity~     of our biobank by carrying-out an exercise intervention study using a novel time-efficient~     strategy that investigators have recently proven to be effective in reducing insulin~     resistance in sedentary young people and in middle aged obese subjects. A time-efficient~     protocol is a critical as lack-of-time is a key reason for not maintaining physical activity~     levels. Finally, investigators have a novel out-bred rodent model that replicates high and~     low exercise training responses and investigators will establish its suitability for future~     drug screening purposes. Because of these substantial pre-existing resources investigators~     believe that our project has a very high probability of delivering on its goals of improving~     the healthcare of European citizens.~   "
86854|NCT01920646|"~     The combination of poverty-related infectious and lifestyle-related non-communicable~     diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and~     nutritious diets for populations depend on availability and accessibility of a variety of~     plant and animal foods, within a context that promotes and supports healthy behaviour. Food~     based strategies, such as supplementation, food fortification, and diversification of crops,~     are used to achieve optimal dietary requirements to combat malnutrition, including~     micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use~     of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately,~     several studies from all over Africa have shown that there is a shift from traditional diets~     as result of the preparing techniques and the absence of women in homes. Furthermore,~     indigenous and traditional foods are considered as poor people's food.~      Against this background, a joint project between South Africa, Kenya and Benin is designed~     to fill the gaps in knowledge in these countries regarding the availability, acceptability~     and consumption and evidenced based benefits of foods from local biodiversity. The main aim~     of the study in South Africa is to provide empirical evidence of how the role of~     biodiversity can be translated into improved health status in contemporary poor rural and~     urban communities in the North West Province of South Africa. In order to achieve this it is~     important to gain knowledge on the possibility of using ALVs as a strategy to alleviate~     micronutrient deficiencies. Therefore an intervention study to determine the effect of~     selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of~     school children (grade R-4) residing in contemporary poor rural community in the North West~     Province, South Africa has been designed.~   "
86855|NCT01920633|"~     This is a single visit study in which people with Down syndrome aged 12-30 will attend the~     clinical center to undergo assessments to evaluate their eligibility for potential~     enrollment in the future BP27832 Phase II clinical study which will evaluate the efficacy,~     safety and tolerability of RG1662. Study participants may withdraw from this study at any~     time and for any reason.~   "
86856|NCT01920503|"~     Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary~     epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3%~     of all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and~     treat with a range of sensitivity and specificity, and also the advantage and disadvantage~     of its modality. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only~     curative option and usually requires a major hepatic resection in addition to resection of~     the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of~     patients due to locally advanced disease, distant metastases or comorbidity in elderly~     patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low~     5-year overall survival (OS).~      Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from~     systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with~     systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop~     distant metastases at late stages only, locoregional therapy is an interesting therapeutic~     strategy.~      Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing~     radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as~     internal radiation therapy yielded promising results in the last couple of years.~      TACE is safe and may be effective for prolonging the survival of patients with nonresectable~     combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the~     historically reported survivals of these patients. Tumor vascularity is highly associated~     with tumor response. The patient survival period after TACE for combined~     HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity,~     Child-Pugh class, and presence or absence of portal vein invasion.~      Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several~     European studies have reported the efficacy and safety TACE for ICC.~      The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated~     with locoregional approach within and outside Europe can help the investigators evaluate a~     larger and non-ambiguous sample population. This would help the investigators evaluate the~     technical success rates, clinical success rates, feasibility and safety of TACE for ICC.~   "
86857|NCT01920490|"~     The investigators have shown that decoupling of brain networks when feeling guilty is the~     first potential functional neuroimaging biomarker of risk of major depression. It remains~     detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was~     found while people felt guilty during functional magnetic resonance imaging (fMRI) relative~     to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target~     for interventions to reduce the largely increased risk of recurrent episodes in people who~     have had one episode but are currently remitted. To our knowledge, however, there is no~     proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected~     and fed back to the participants after a short temporal delay in a real-time fMRI setting~     and whether coupling can be increased through neurofeedback training. This project aims at~     developing the first fMRI neurofeedback system to treat self-blame-selective neural~     decoupling and to test its feasibility in people with major depressive disorder currently~     remitted from symptoms.~   "
86858|NCT01920477|"~     Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening~     autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel~     monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is~     expressed only in B lymphocytes.~      The purpose of this study is to evaluate the efficacy, tolerability, and safety of~     ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered~     once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both~     Week 0 and Week 4) in subjects with PV. It is anticipated that with sustained B-cell~     depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti~     Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease will result.~   "
86859|NCT01920464|"~     this study has been request by french health authorities to evaluate the use of flixovate in~     infants and its place in the treatment pathway.~      this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of~     Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the~     population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.~     2/Description of the conditions of use of Flixovate® in infants aged less than 12 months~     (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent~     treatments etc.).~   "
86860|NCT01920451|"~     Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in~     returning Veterans, and both conditions are known to increase the risk of cardiovascular~     disease. Research suggests that those with insomnia are at triple the risk of high blood~     pressure as compared to normal sleepers, and that having both insomnia and short sleep~     increases this risk to more than five times that of normal sleepers. These research findings~     suggest that recently deployed Veterans with insomnia may be at increased risk of developing~     high blood pressure, and this possibility is consistent with previous research. Vietnam era~     Veterans with combat-related PTSD assessed in 1985 were twice as likely to have died of~     early-onset heart disease relative to their non-PTSD counterparts when reassessed in 2000.~      Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across~     several studies as well. Compared to individuals without PTSD, those with PTSD seem to have~     lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there~     has been very little research examining the impact of behavioral sleep interventions on~     health outcomes, and even fewer that are specific to a PTSD or Veteran population. The~     purpose of this study is to determine if treating insomnia results in improved blood~     pressure and cardiac function in recently deployed Veterans with PTSD. The findings of this~     research will serve as pilot data for a future grant application testing the efficacy of~     Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in~     Veterans with PTSD using a full-scale randomized trial design. We are hypothesizing that~     improved sleep will be significantly associated with improved blood pressure and increased~     heart rate variability (improved autonomic function) in adults receiving CBTI compared to~     those in a wait-list control condition.~   "
86861|NCT01920438|"~     A gastrostomy is a feeding tube that communicates from the skin directly into the stomach.~     It is a device frequently used in children that have feeding difficulties or are unable to~     maintain normal growth via oral feeds. The same device may be inserted in two ways: the~     percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible~     camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray~     imaging. Both methods of insertion have been used in children for more than 20 years, but it~     is not clear which is the best method. Both methods are associated with complications,~     including injury to other abdominal organs and leakage leading to sepsis. There are no~     randomised controlled trials comparing the two techniques.~      We aim to compare the outcome of both methods of gastrostomy insertion in children, with~     emphasis on the complication rates. We have devised a complication score with weightage~     assigned to each complication according to its severity.~      A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per~     group. The primary outcome will be the overall total complication rate.~   "
86862|NCT01920425|"~     The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView~     to electronic and hand-written diaries for tracking medication state in the home.~     Demonstrating comparable or superior results will further support use of the Kinesia~     HomeView system as an outcome measure in clinical drug trials.~   "
86863|NCT01920412|"~     This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage~     Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).~   "
86864|NCT01920399|"~     Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ~     -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese~     subjects.This study data will be used to support CAZ-AVI NDA in China.~   "
86865|NCT01920386|"~     A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of~     Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in~     Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.~   "
86866|NCT01920373|"~     1.0 BACKGROUND AND HYPOTHESES~      1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in~     every joint. These include the replication of cells that produce matrix, enzymes, protease~     inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a~     release of breakdown products into the synovial fluid. Enzymes and phagocytes are required~     to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown~     in well-regulated balance. In the degenerative state this balance is upset producing~     inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone.~     Common causes of such alterations include increased loading, physical stress, and traumatic~     injury to the joint.~      1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that~     they inhibit prostaglandin synthesis and decrease the activity of collagenase and other~     enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic~     agent that has several potential advantages over corticosteroids for the treatment of~     degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown~     to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores~     intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances~     joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet~     rich plasma injections for treatment of knee cartilage degenerative lesions and~     osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain~     and recovering articular function. Similarly, platelet rich plasma has shown to have better~     outcomes than corticosteroid injections in the management of lateral epicondylitis, and~     better outcomes than hyaluronic acid injections in the management of osteochondral lesions~     of the talus.~      1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint~     are focused primarily on palliation by reducing inflammation and inflammatory mediators.~     This study seeks to validate a therapeutic agent that has the potential to actively prevent~     the progression of degeneration in addition to reducing pain and inflammation~   "
86867|NCT01920360|"~     The objectives are to evaluate the effects of immersion bath with sulphurous water in pain,~     joint mobility and quality of life in patients with knee osteoarthritis. Patients will~     undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for~     ten weeks.~      The expected results are: reduction of pain, improved range of motion of the lower limbs~     with consequent increase in muscle mass improvement in postural balance, which will come due~     to the reduction of pain and improvement movements of the lower limbs; greater independence~     in performing the activities of daily living, better quality of life.~   "
86868|NCT01920347|"~     The trial will evaluate the use of the Neurological Pupil index NPi, measured with the~     digital pupillometer (NeurOptics) compared to clinical examination for better reliability.~     The investigators hypothesize that digital evaluation will offer a higher sensitivity/~     specificity compared to clinical examination.~   "
86869|NCT01920334|"~     A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU~     patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug~     (zolpidem controlled release).~      The study hypothesis is that sleeping better can improve the heart recovery in patients with~     a diagnosis of acute coronary syndrome.~   "
86870|NCT01920321|"~     Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of~     bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.~      Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral~     bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an~     inflammatory airway and parenchymal injury and consequently fibrotic response resulting in~     LVR;~   "
86871|NCT01920308|"~     The purpose of this study is to assess the deliverability, clinical utility and~     effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent~   "
86872|NCT01920295|"~     Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy~     compared to second choice after failed medical therapy~   "
86874|NCT01920269|"~     In laboratory and clinical studies, intravesical electromotive drug administration increased~     mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive~     urothelial bladder cancer. The investigators' aim was to compare transurethral resection of~     bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection~     and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in~     patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will~     be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant~     intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over~     60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40~     mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric~     current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant~     electromotive and passive diffusion mitomycin groups who are disease-free 3 months after~     induction treatment, will be scheduled to receive monthly intravesical instillation for 10~     months, with the same dose and methods of infusion as initial assigned treatment. All~     patients will be assessed for safety. The investigators' primary endpoints are recurrence~     rate and disease-free interval. Analyses will be done by intention to treat.~   "
86875|NCT01920256|"~     Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals~     are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved,~     and patients become susceptible to devastating complications and greater health care~     expenses. Studies have shown that regular monitoring and therapy adjustments are a~     prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of~     regular monitoring and therapy adjustments have been hindered by high clinic workload and~     shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less~     than 20% of patients with type 2 diabetes. The overwhelming majority are managed by~     providers who may lack the necessary expertise or time to deliver optimal disease~     management, particularly when insulin is prescribed.~      Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients~     that complement primary care, personalize the frequency of remote disease interventions and~     employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes~     and patient satisfaction compared to usual endocrine clinic care, while reducing workload~     and increasing the clinic capacity. The intervention clinic will employ regular remote~     communications initiated by the endocrinologists, based on tailored individual plans.~     Frequent remote monitoring and interventions will reinforce attainment of the therapy goals~     and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload~     will decrease and it will be able to accommodate more patients with type 2 diabetes than~     traditional endocrine clinics. The aims of the study are to test this new endocrine clinic~     model in a clinical trial by monitoring clinical parameters, patient satisfaction and~     clinical workload. The long-term objectives are to modify the current model of endocrine~     care for patients with type 2 diabetes.~   "
86876|NCT01920243|"~     This study will look at the use of a telehealth version of a self management program in~     individuals with both new onset and chronic traumatic spinal cord injuries. The program is~     called Health Mechanics. It is meant to enhance self management skills related to neurogenic~     bladder and bowel management to prevent associated problems and improve Quality of Life~     (QOL). This program is based on the needs and strengths of individuals with SCI. It focuses~     on enhancing skills, encouraging positive health behaviors, empowering people within their~     own environments, and recognizing that people differ in their resources and abilities. The~     skills that are part of the intervention are: attitude, self-monitoring, problem-solving,~     communication, organization and stress management. This study will address those skills in~     the context of bladder and bowel health, with expectations that these skills to be useful in~     other areas of life as well.~      The investigators hypothesize that individuals in the Health Mechanics intervention group~     will:~        -  show greater improvements in problem solving skills, healthy attitudes about disability~          and knowledge of SCI management skills than will the control group~        -  have greater adherence to recommended bladder and bowel management behaviors than the~          control group~        -  have fewer bladder and bowel complications than the control group~        -  have higher levels of QOL than the control group~      In other words, this study will investigate the effectiveness of a telehealth version of~     Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel~     management in an attempt to prevent associated complications and improve QOL.~   "
86877|NCT01920230|"~     The aim of this study is to examine the effectiveness of intervention based on mindfulness~     and acceptance-commitment therapy (ACT) in the recovery from job burnout. The 8-week~     intervention is delivered using jointly face-to-face group meetings and web-based program.~     The study hypothesizes that the Muupu-program is more effective than the normal practices~     when promoting work well-being in Finland. The participants are recruited from Finland.~   "
86878|NCT01920217|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was~     promising genetic biomarker for sepsis patients. The present study was designed to screen~     several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to~     be a new target for the treatment of sepsis.~   "
86879|NCT01920204|"~     Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe~     disabling symptoms. Almost all patients have fatigue, a compromised quality of life,~     hampering normal functioning. Because this form of mastocytosis is not considered~     life-threatening, mast cell eradication has never been applied and patients receive only~     symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown~     activity regarding symptom control and decrease of malignant mast cells in patients with~     aggressive systemic mastocytosis (ASM) or mast cell leukemia~   "
86880|NCT01920191|"~     RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides~     have been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent~     vaccine adjuvant with broad innate and adaptive immune enhancing effects. IMA 950 and~     Poly-ICLC will be administered to patients alongside standard primary therapy for~     glioblastoma. This includes the alkylating drug temozolomide (TMZ). Effective~     vaccine-induced immune responses associated with prolonged survival have been observed in~     glioblastoma patients during TMZ adjuvant therapy, suggesting a possible synergistic effect.~     A second component of glioblastoma standard treatment is external beam irradiation of the~     tumor site post-surgery. As a side effect, potentially beneficial tumor-infiltrating immune~     cells may also be killed by radiation. However, the combination of radiation with~     immunotherapy has been suggested to be favorable both in pre-clinical models.~   "
86881|NCT01920178|"~     The purpose of this study is to assess the clinical efficacy and safety of the PinPointe~     Foot Laser device for the treatment of patients with onychomycosis who have been previously~     treated with oral Terbinafine and failed.~   "
86884|NCT01920139|"~     The study was performed to determine if either ultrasound guided core biopsy or fine needle~     aspiration of an axillary lymph node has superior sensitivity in detecting metastatic~     carcinoma from the ipsilateral breast.~   "
86886|NCT01920113|"~     Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine~     is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects,~     but it is limited to use alone. The investigators designed this study to compare the effect~     and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal~     Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the~     procedure.~   "
86887|NCT01920100|"~     This project is based on a three-year program that aims to improve the knowledge of the~     socioeconomic consequences of dementia in Norway. By including patients with and without~     dementia in four different cohorts (from nursing homes, from memory clinics, home-dwelling~     persons with dementia and elderly persons without dementia), the project's aim is to~     describe tha course of dementia, the economical cost of dementia and to look into possible~     risk factors for dementia.~   "
86888|NCT01920087|"~     The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical~     Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research~     project targets patients with chronic constant facial pain and excludes patients with~     primarily paroxysmal pain.~   "
86889|NCT01920074|"~     RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to~     severe pain associated with chronic anal fissure approved in June 2011 by the US Food and~     Drug Administration (FDA) for adults. The purpose of this study is to assess the safety,~     pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents~   "
86890|NCT01920061|"~     This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either~     docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess~     the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with~     advanced cancer in order to determine the maximum tolerated dose in each combination.~   "
86891|NCT01920048|"~     This study will assess whether percutaneous coronary intervention (angioplasty of the heart~     arteries) can improve survival and reduce hospitalization in patients with heart failure due~     to coronary disease, who have been treated with the best contemporary medical therapy.~   "
86892|NCT01920035|"~     Localized cooling/hypothermia using the UroCool System during robotic-assisted radical~     prostatectomy (RARP) surgery results in an improved overall return to continence, (defined~     as not wearing any protective urinary pads), compared with standard of care in men~     presenting for RARP.~   "
86893|NCT01920022|"~     Women having abortions are at high risk for subsequent unintended pregnancy and repeat~     abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long~     acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the~     most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies~     in surgical abortion patients, show that quickstart of a LARC - i.e., inserting it during~     the surgical procedure - is associated with substantially greater use of that method six~     months later than requiring women to return later to get the device. However, today a~     majority of women chose medical abortion. The clinical routine is to insert LARCs at the~     follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of~     the abortion treatment at home and do not return for a follow up. Thus, the possibility to~     quick start a contraceptive method in medical abortion would be a major advantage especially~     if this could be done at the time of administration of mifepristone.~   "
86894|NCT01920009|"~     Introduction:~      In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial~     infarction (MI) and will need secondary prevention medications. Longterm adherence to~     secondary prevention therapies remains poor, nonadherence to medication in MI patients~     ranges from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not~     refill their cardiac medications (2). Strategies to tackle the burden of non adherence could~     involve pharmacy care and The New Medicine Service (which is a service provided by community~     pharmacists to help patients on long term medications for chronic diseases) with a~     motivational interview incorporated as part of the counselling session of a community~     pharmacist. Communication of health providers with patients and between health providers~     could also be an important strategy to improve adherence.~      Cardiovascular disease is high in all ethnic groups as well as in the general population;~     however it is the South Asians who have the highest prevalence of coronary heart disease~     (CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of~     40 years (3).~      Aim of this study:~      This study is to investigate the feasibility and potential impact of a pharmacy care~     intervention involving motivational interviews and referral to the New Medicine Service in~     coronary heart disease patients on adherence to secondary prevention medication and on~     outcomes of coronary heart disease.~      Method:~      The study is designed as a prospective, controlled feasibility/pilot, intervention study.~     The study has two phases.~      In the intervention phase a total of 200 coronary heart disease patients discharged from the~     London Chest Hospital will be enrolled into the study and followed up for one year.~     Pharmacies from up to six London Boroughs will be invited to take place in the study.~     Pharmacies will be randomised using a table of random numbers into intervention site or~     control site. The pharmacists working in the intervention pharmacies will be invited for~     training on the delivery of the intervention and on motivational interviewing. The~     intervention will be performed by community pharmacists. Recruitment of patients will take~     place in the hospital. In the interview phase 20 patients from South Asian backgrounds will~     be invited for a telephone interview to study the effect of their beliefs and cultural~     backgrounds in regards to their adherence to cardiac medication.~      Outcome measures:~      The primary outcome measure is self report adherence with coronary artery disease medication~     employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low~     density lipoprotein cholesterol) in addition to data regarding the feasibility of the~     intervention.~      Analysis:~      Both quantitative and qualitative data analysis will be performed.~   "
86895|NCT01919996|"~     This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory~     post-marketing requirement to provide data regarding visual abilities in children taking~     azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary~     objective of the study is to examine the incidence of clinically significant worsening in~     any of the following ophthalmic exams: best corrected visual acuity (distance), color~     vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a~     group of approximately 30 pediatric patients taking azithromycin oral solution for treatment~     of an authorized indication of use (pharyngitis/ tonsillitis).~   "
86931|NCT01919528|"~     The central venous catheterization (central line placement) is the common procedure~     performed in the intensive care unit. This procedure is performed by percutaneous puncture~     of so called 'the central vein' and than advancement of the catheter over the guidewire~     (Seldinger technique). The tip of the catheter is left in the superior vena cava in the~     vicinity of the right atrium of the heart. Central veins are large veins in the human body~     passing the blood into the heart.~      Typical, clinical indications for the central line placement in the intensive care unit are~     hemodynamic monitoring, volume monitoring, administration of medications, long-term total~     parenteral nutrition, access for renal replacement therapy, difficult peripheral~     catheterization.~      There are two methods of the central venous catheterization in terms of visualization. First~     and older is the blind technique. The operator is locating the anatomical landmarks and then~     performing the entire procedure blindly by percutaneous puncture. This is called the~     landmark technique. Second and new is the ultrasound-guided technique. The operator is~     locating the vein using ultrasonography and then performing the entire procedure under~     ultrasonographic visualization. The real time ultrasound-guided central venous~     catheterization became the standard of care in recent years mainly because of safety issues~     (is regarded as safer than landmark technique)~      The catheterization of the axillary vein is not popular procedure in daily clinical~     practice. But it can be reasonable and safe alternative to others, typically performed~     central venous catheterizations like the internal jugular vein and the subclavian vein~     catheterizations.~      The main intention of this study is to assess usefulness and safety of the real time~     ultrasound guided axillary vein catheterization in mechanically ventilated patients admitted~     to the intensive care unit.~   "
86896|NCT01919983|"~     Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden~     cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with~     HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been~     shown to be an effective, but costly therapy in preventing SCD. At present, left ventricular~     systolic dysfunction is our best independent predictor of SCD, but only moderately predicts~     those patients who will eventually benefit from the placement of an ICD and, in most cases,~     left ventricular (LV) systolic dysfunction is a non-modifiable risk factor once acquired. As~     a result, there exists an intensive search for biomarkers that could improve the prediction~     of SCD and have the potential for risk factor modification.~      Experimental and clinical evidence has established that inflammation plays a critical role~     in stable coronary disease, plaque rupture, acute myocardial infarction, heart failure, and~     SCD. Studies at our institution have demonstrated that elevated levels of hsCRP and~     Interleukin-6 are predictive of arrhythmic SCD; however, the mechanism of causing this~     increased risk is unclear.~      Another well-known risk factor for SCD is abnormal sympathetic innervation. The most robust~     clinical test of sympathetic innervation to date is Iodine-123 Metaiodobenzylguanidine~     (MIBG) imaging with gamma scintigraphy. MIBG imaging has emerged as one of our strongest~     predictors of SCD by detecting sympathetic nervous system abnormalities in patients with HF.~     Preclinical and clinical evidence suggests that myocardial inflammation adversely affects~     myocardial innervation.~      Based on these findings, the investigators hypothesize that elevated levels of inflammatory~     biomarkers are associated with abnormal sympathetic innervation as measured by MIBG imaging.~     The investigators aim to establish the strength of this association. This proposal will~     leverage unique access to the largest, most extensively phenotyped cohort of patients who~     have undergone ICD implantation for primary prevention of SCD, the PRospective Observational~     Study of the ICD in SCD, (PROSE-ICD).~   "
86897|NCT01919970|"~     Autism spectrum disorders affect as many as 1 out of 88 children and are related to~     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,~     such as anxiety, are common and may cause substantial distress and impairment beyond that~     caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial~     to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment~     as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.~   "
86898|NCT01919957|"~     This study has two purposes: firstly, a better understanding of the neurobiological~     processes underlying episodic memory and, secondly, the development of useful clinical~     applications for epileptic patients, in particular the prediction of postoperative memory~     deficits and the development of cognitive remediation therapies.~      Memory performances during a fMRI experiment will be assessed in controls and epileptic~     patients before and after the surgery.~   "
86899|NCT01919944|"~     The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and~     dermatological reaction observed after healthy volunteers are injected with Substance P in~     comparison with placebo.~   "
86900|NCT01919931|"~     Candida albicans is one of the most common nosocomial infection and the onset relies on the~     host immune status. The purpose of this study is to determine the immunological profile of~     patients infected with Candida albicans, that could ideally lead to a strategy to identify~     patients who could benefit from prophylaxis.~   "
86901|NCT01919918|"~     The purpose of the study is to find out more about the mechanism by which neural feedback~     from the working muscle affects the development of central fatigue during exercise. Subjects~     with chronic heart failure (HF) and healthy subject counterparts will be tested to determine~     the mechanisms accounting for the premature fatigue characterizing HF patients during~     physical activity.~   "
86902|NCT01919905|"~     The purpose of this study is to evaluate the effect of heat on the bioavailability of~     vitamin D in industrially fortified mozzarella cheese baked with pizza.~   "
86903|NCT01919892|"~     Thirty subjects with a DSM-IV (Diagnostic and Statistical Manual, fourth version)diagnosis~     of BPD during a depressive or hypomanic episode will be divided in two groups according to~     age and time of illness. All patients will receive lithium (flexible therapeutic dose) for 6~     weeks and improvement will be evaluated weekly using depression and mania rating scales;~     this study also objectives to identify state/trait markers and predictors of response.~   "
86904|NCT01919879|"~     This is a multicentric, phase II and open label study.75 patients are expected to be~     randomized in 35 centers. The main objective is to assess the efficacy and safety of~     Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory~     wtKRAS metastatic colorectal cancer.~   "
86905|NCT01919866|"~     Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells~     in combination with a toxicity reduced conditioning regimen or with standard conditioning~     regimens according to underlying disease.~   "
86906|NCT01919853|"~     The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction~     (MBSR) to an attention control psycho-educational support group in treating cancer-related~     fatigue (CRF) in early-stage (0-III) post-treatment cancer survivors with~     clinically-significant CRF. The study will collect, store, and later analyze blood and urine~     samples for several biomarkers that may be linked to persistent CRF in cancer survivors.~   "
86907|NCT01919840|"~     Main objective:~      Determine whether by introducing thromboelastograph, the investigators reduced the number of~     packed red cells received by each patient (median) compared to the usual protocol, in which~     the indication for transfusion is based on laboratory tests: Prothrombin time, time~     activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.~      Design:~      Prospective randomized controlled trial and single blinded.~      Disease or disorder under study:~      Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass~     (CPB).~      Primary endpoint:~      median transfusion of packed red blood cells per patient. Study population Male and female~     patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed~     excessively.~      Duration of treatment:~      The coagulation monitoring methods tested are made from protamine administration to CEC~     output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied~     critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a~     150ml / h).~   "
86908|NCT01919827|"~     Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to~     evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients~     with diagnosis of idiopathic pulmonary fibrosis.~      Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial~     administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in~     patients with mild-to-moderate idiopathic pulmonary fibrosis.~      Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall~     of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.~   "
86909|NCT01919814|"~     The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce~     appetite and hunger given on the same day of testing.~   "
86911|NCT01919788|"~     Diabetes mellitus type I (DMI) is characterized by lack of endogenous insulin and these~     patients are 100% dependent on insulin substitution to survive. Diabetes mellitus type II~     (DMII) is characterized by reduced insulin sensitivity and sometimes also reduced insulin~     production, thus patients with DMII might also be dependent on insulin substitution.~      Insulin is produced in- and secreted from the pancreas when blood glucose concentration~     rises during- and after a meal. Insulin increases cellular uptake of glucose leading to~     lower blood glucose concentration. Substitution with insulin is/can be necessary in DM, but~     at the same time it induces the risk of hypoglycemia. This makes treatment with insulin a~     balancing act between hyper- and hypoglycemia.~      A hypoglycemic episode is a dreaded consequence of insulin overdosing, and also a very~     frequent reason for hospital admission in patients with DM. Examples of hypoglycemic~     symptoms may be; shaking, a sense of hunger, sweating, irritability progressing to lack of~     relevant cerebral responses and eventually coma, convulsions and possibly death. People with~     diabetes lose the ability to sense of low blood glucose with time, because of a lack of~     appropriate counter-regulatory responses, hereby increasing the risk of severe hypoglycemia.~     Understanding normal physiologic counter regulatory mechanisms during hypoglycemia is of~     major importance to patients with DM and has the potential to change medical treatment in~     diabetes, to reduce the risk of hypoglycemia.~      Hypothesis: Hypoglycemia counteracts insulin signaling via hormone-dependent intracellular~     counter-regulatory mechanisms, involving phosphorylation of specific signaling proteins.~      Aim: To define counter-regulatory mechanisms in muscle- and fat tissue during hypoglycemia,~     and to investigate the effect of insulin on lipid metabolism in healthy- and type I diabetic~     subjects.~   "
86912|NCT01919775|"~     To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is~     related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we~     used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with~     amnesia following treatment of ACoA aneurysm.~   "
86913|NCT01919762|"~     To assure the uniform collection, handling, storage and transport of patient whole blood~     specimens and associated information to support validation of the T2 Bacteremia Assay.~   "
86914|NCT01919749|"~     This study will use proteomic and genomic profiling to analyze tumor tissue to see if~     treatment selected by this analysis will benefit patients.~   "
86915|NCT01919736|"~     The objective of this project is to determine the effects of gait-retraining on articular~     cartilage composition, gait mechanics, pain and function in persons with mild to moderate~     knee osteoarthritis (OA).~   "
86916|NCT01919723|"~     This purpose of this study is to measure platelet response to ticagrelor and eptifibatide~     bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion~     administrated after cardiac catheterization in patients undergoing non-emergent percutaneous~     coronary intervention.~   "
86917|NCT01919710|"~     Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of~     neutropenia induced by chemotherapy of cancer patients.~   "
86918|NCT01919697|"~     This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in~     patients with Chronic Idiopathic Constipation (CIC).~   "
86919|NCT01919684|"~     This study is designed to evaluate the safety and tolerability of a range of single oral~     doses of LGD-6972 in healthy subjects. Additionally, the study will characterize the~     Pharmacokinetic profile in healthy subjects under fed and fasted conditions and in subjects~     with Type 2 Diabetes Mellitus under fasted conditions.~   "
86920|NCT01919671|"~     The purpose of this study is to assess the effects in improving life self-care ability of~     stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos~     for 90 days.~   "
86921|NCT01919658|"~     The primary objective of the study is to compare motor strength in knee extension between~     two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and~     one receiving a distal thigh block of the saphenous nerve. The secondary objective is to~     compare the pain relief and functional outcomes in these two groups.~   "
86922|NCT01919645|"~     Physical exercise programs are effective and safe for the improvement of the sleep~     efficiency in patients with Rheumatoid Arthritis.~   "
86923|NCT01919632|"~     Background: The impact of demographic changes on workplace has increased the importance of~     effective occupational preventive health programs. The primary goal of these programs is the~     improvement of overall health status (and therefore increase productivity and decrease~     healthcare costs) of the increasingly older workforce through positive lifestyle behavior~     change.~      A one- year preventive health behavior-change program for the employees of the company~     British Petrol (BP) shall be scientifically evaluated. The initial stage of the program~     consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of~     supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups.~     In the second phase of the program, the participants receive a recommendation to continue~     exercise regularly unsupervised for one year, and receive monthly supervised exercise~     training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2)~     and at 12 months (V3).~   "
86924|NCT01919619|"~     The goal of this clinical research study is to study the safety of REVLIMID® (lenalidomide)~     when given with YERVOY® (ipilimumab) after a stem cell transplant. Researchers also want to~     find out if lenalidomide given with ipilimumab may help to control leukemia and lymphoma.~   "
86925|NCT01919606|"~     The primary objective of this study is to determine the optimal of two different volumes of~     EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP)~     for prolonged postoperative analgesia in subjects undergoing open total abdominal~     hysterectomy.~   "
86926|NCT01919593|"~     To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10%~     povidone iodine in reducing blood culture contamination in pediatric patients.~   "
86927|NCT01919580|"~     Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the~     treatment of oral cancer using Ga12 inhibitor.~   "
86928|NCT01919567|"~     Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the~     Treatment of Oral Cancer Using SOX-9 Inhibitor.~   "
86929|NCT01919554|"~     The purpose of this study is to investigate the safety and tolerability of different doses~     of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house~     dust mite-associated allergic rhinitis.~   "
86930|NCT01919541|"~     The investigators hypothesize that individuals who receive a personalized 4 week~     prehabilitation program consisting of exercise and nutrition counselling with post-workout~     whey protein supplementation will show, before colorectal surgery, improved insulin~     sensitivity, inflammatory profile, and substrate utilization compared to baseline measures.~     These results will translate into a higher functional capacity before surgery as~     demonstrated by an improvement in 6-minute walking test.~   "
86933|NCT01919502|"~     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,~     the investigators would like to document the feasibility and acceptability of a~     semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring~     protocols to offer women and health care providers a new choice of diagnostic tools to~     confirm early pregnancy. The pilot will help us to better understand how this tool~     complements existing monitoring protocols. If a suitable addition or replacement to repeat~     blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make~     assisted fertility treatments more patient-friendly. This study seeks to test this~     innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test~     (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks~     after egg retrieval/embryo transfer or intrauterine insemination.~      The investigators hypothesize that the test, which can be used at home by women, will~     provide confirmation of the presence of a pregnancy compared with standard serum hCG testing~     because 1) it has sensitivity and specificity that correlates well with serum testing, and~     2) it can be used at home and thus earlier to determine presence of hCG.~   "
86934|NCT01919489|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Increasing evidence indicates that incretin-based agents are safe and effective for the~     hospital management of patients with type 2 diabetes (T2D).~      Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the~     treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous~     insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food~     intake and body weight and improve ß-cell function when administered subcutaneously.~     Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when~     plasma glucose levels are elevated), resulting in low-risk of hypoglycemia when used as~     monotherapy. When compared to insulin glargine therapy, the use of GLP-1 has resulted in~     comparable reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No~     prospective studies; however, have compared the efficacy and safety of liraglutide in the~     hospital setting or after hospital discharge.~      The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus~     glargine insulin in combination to oral anti-diabetic agents (OADs: metformin,~     sulfonylureas, nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks~     of treatment in medicine patients with T2D after hospital discharge.~   "
86935|NCT01919476|"~     Currently, about one third of all women entering pregnancy are obese. The prevalence of~     metabolic disorders during pregnancy has increased concurrently with the rise in maternal~     obesity. Although dietary interventions are used routinely to reduce metabolic disease in~     non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant~     women unless they develop gestational diabetes mellitus. In this study, the investigators~     will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal~     on the postprandial metabolic response. This cross-over, randomized control trial will~     examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test~     meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at~     higher risk for gestational diabetes and the metabolic syndrome. The investigators~     hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and~     improves the postprandial lipid profile in these high-risk women.~   "
86936|NCT01919463|"~     The primary aim of this study is~      - to explore the usefulness of abdominal compression on intubation.~      Other aims include~        1. to investigate the effectiveness and the efficacy of different manners of abdominal~          compression and to analysis the reasons of their success and failure~        2. to get the knowledge of the formation of colon loops and its frequency~        3. to clarify the impact of intubation with loops on adenoma detection rate~   "
86937|NCT01919450|"~     The purpose of this study is to evaluate the consistency of quantitative peak stress~     myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2~     minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson)~     injection. It is anticipated that there will be no or minimal difference between the four~     delay times.~   "
86938|NCT01919437|"~     The purpose of this study is to develop the technology infrastructure for a mobile Web-based~     cognitive and neuropsychological assessment of substance abusers, and to perform a pilot~     trial using neurocognitive tasks designed to demonstrate that our system is statistically~     comparable to current clinical practice.~      The primary hypotheses are that results collected using a web-based data collection platform~     will be comparable (but not necessarily equivalent) to data collected under controlled~     laboratory conditions, that methamphetamine (MA) dependent participants will have worsened~     neurocognitive performance compared to healthy volunteers, and the platform will be~     acceptable to participants.~   "
86939|NCT01919424|"~     This study will compare the methacholine PC20 of two different modern-delivery aerosol~     systems to determine if one may replace the other for use in clinical settings.~   "
86940|NCT01919411|"~     Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery.~     There is minimal data to support this. The investigators' study will aim to demonstrate that~     patients' quality of life and rate of post operative infection is the same whether they~     receive or do not receive antibiotics post operatively. The investigators hypothesis is that~     the disease specific quality of life of patients taking post-operative antibiotics is not~     inferior to the quality of life of patients who do not take post-operative antibiotics, and~     the rate of post-operative infections are the same. The investigators' specific aim is to~     compare validated symptom scores between post-operative populations who are given or are not~     given antibiotics. Rates of infections in the first 10 days after surgery will be recorded.~     The investigators will also compare endoscopic grades of sinus cavities during the~     post-operative follow up exams as an additional outcome measure.~   "
86941|NCT01919398|"~     The primary purpose of this study is to assess the safety and tolerability of LY2940680 up~     to the global recommended dose in Japanese participants with advanced solid cancers.~   "
86942|NCT01919385|"~     This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type~     1 diabetes that are currently using an insulin pump.~   "
86943|NCT01919372|"~     This project is based on the contribution that could offer a technological system for a~     continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic~     complications in high risk population.~      The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in~     high cardiometabolic risk individuals of a telemedical platform integrating applications for~     monitoring and providing recommendations to improve lifestyle habits (diet and physical~     activity) in a healthier way.~      The study population are obese subjects (type I or II) aged between 25 and 65 years with a~     12 month follow-up. In this population it will be analysed the cost-effectiveness of a~     telemedic assistance with a technological system and its ability to modify lifestyle habits,~     reduce weight and cardiovascular risk associated parameters.~      Previously to the clinical implementation, a pilot study for testing the telemedical system~     will be made. Efficacy and security variables will be evaluated along the study.~   "
86944|NCT01919359|"~     Nutritional supplementation is more effective than placebo in the reduction of redness and~     bruising following facial ablative laser resurfacing treatments and following soft tissue~     filler injections to the lips and/or malar areas.~   "
86945|NCT01919346|"~     The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of~     Delayed Graft Function following deceased donor kidney transplantation. Based on~     experimental data and supportive observations in humans associating complement gene~     upregulation with ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a~     key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is~     further hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5~     cleavage in humans will be an effective prophylactic agent to prevent IR injury in high risk~     recipients. This trial is a prospective, randomized study to test the efficacy of eculizumab~     vs. placebo given once at the time of transplantation and once again 24 hours later in~     preventing delayed graft function in first adult recipients of deceased donor kidneys.~   "
86946|NCT01919333|"~     This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy~     on ovarian reserve as measured by serum antimullerian hormone and to study the different~     effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the~     non-ovarian pelvic surgery.~   "
86947|NCT01919320|"~     Study Purpose~      The purpose of this PAS is to confirm that patients implanted with the temporary Total~     Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes~     similar to those patients implanted with the TAH-t and supported with the CSS Console. The~     data collection mechanism for this study is the INTERMACS Registry.~      Study Objectives~      Primary Objective 1:~      To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver~     System have outcomes similar to those patients implanted with the TAH-t and supported by the~     CSS Console.~      Primary Objective 2:~      To review additional data (patient survival, adverse event rates and bridge to transplant~     rates) to support the conclusion that the use of an artificial heart is reasonable and~     necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid~     patients.~      Secondary Objective:~        -  To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions~          in the INTERMACS Registry.~      Study Hypothesis: Primary Objective 1~      The primary hypothesis is that the survival rate (defined as transplant prior to three~     months, transfer to the Freedom Driver System support prior to three months, or continuing~     on implant driver support at three months, whichever occurs first) for patients supported~     with the Companion 2 Driver System is not worse than the survival rate for patients~     supported with the Circulatory Support System (CSS) Console.~      Data Collection~      The data will be collected as defined in the INTERMACS Protocol and the patients will be~     followed at one week, one month and three months or until their study endpoint is reached.~      Data Analysis~      Primary Objective 1:~      Data analysis will provide descriptive statistics on enrollment, adverse events, and~     outcomes for TAH-t patients who were implanted while supported with the Companion 2 Driver~     System compared to TAH-t patients who were implanted while supported with the CSS Console.~      Primary Objective 2:~      Data analysis will provide descriptive statistics on enrollment, adverse events, and~     outcomes for all TAH-t patients enrolled in the INTERMACS Registry.~   "
86948|NCT01919307|"~     This feasibility study will determine the tolerability of auricular acupuncture, compliance~     with self-reported seizure tracking, and the quality of a proposed sham acupuncture protocol~     to inform the design of a large, multi-center, placebo-controlled, double-blind study to~     demonstrate the therapeutic effect of auricular acupuncture for the treatment of~     Non-Epileptic Seizures.~   "
86949|NCT01919294|"~     The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis~     (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months~        1. improve severity of steatosis on liver biopsy (Primary Question)?~        2. improve severity of associated steatohepatitis on liver biopsy?~        3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy~          (1H-MRS)?~      The work proposed here is an open pilot study of 10 patients, the main aim of which is to~     assess the effect size of TRT in regard to these end points (regarding which there are no~     published data), thereby allowing power calculations for a more definitive phase II trial.~     Other aims would be assessing recruitment and consent rates, which would also inform the~     design of the larger study.~   "
86950|NCT01919281|"~     The aim is to investigate whether strength training or high intensity interval training is~     effective in improving insulin sensitivity, cardiovascular outcomes, body composition and~     reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).~      Few studies have examined the effect of strength training alone on insulin sensitivity,~     reproductive outcomes and body composition in women with PCOS. Most previous studies on~     aerobic exercise in PCOS have applied moderate exercise intensity.~   "
86951|NCT01919268|"~     This study aims to evaluate the effectiveness of the addition of the interferential current~     to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low~     back pain.~   "
86952|NCT01919255|"~     The purpose of this study to bowel cleansing evaluation of mixed two other type bowel~     preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).~   "
86953|NCT01919242|"~     Gastric cancer is still one of the main health care issue and gastrectomy with lymph node~     dissection is the only chance to be cure. Even though the development and standardization of~     gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with~     less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality~     was reported in West. There has been several indexes which can define the complications~     after surgery, but adapting it into clinical practice is sometimes difficult due to the~     heterogeneous opinion between surgeons. Thus for clear defining the complications after~     surgery, consensus between many surgeons and prospective cohort study is necessary. The~     purpose of this study is collecting the complications data after gastric cancer surgery and~     defining it with every week meeting by at least 6 or more surgeons' discussion.~   "
86954|NCT01919229|"~     This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.~   "
86977|NCT01918930|"~     The purpose of this study is to gain a better understanding about how the study drug MGA271~     works. No test drug will be given in this study. Patients with easily accessible tumors at~     the screening visit for participation in Study CP-MGA271-01 will be asked to participate in~     this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle~     biopsies.~   "
86955|NCT01919216|"~     The placebo effect represents a potent treatment for MDD—placebo response in acute~     randomized controlled trials (RCTs) of antidepressant medications averages 30%, and~     meta-analyses have estimated the proportion of medication response attributable to placebo~     to be 50-75%. Patient expectancy is the mechanism of placebo effects in antidepressant RCTs~     and has been positively associated with medication response. Determining how expectancy~     alters the course of MDD could lead to methods of optimizing placebo effects and improving~     the treatment of MDD. In addition, investigating the neurobiology of placebo effects has the~     potential to elucidate the pathophysiology of MDD and the mechanisms of action of~     antidepressant treatments. Brain regions implicated in expectancy and placebo effects~     comprise prefrontal cortical (PFC) areas, amygdala, insular cortex, rostral anterior~     cingulate cortex (rACC), and dopaminergic reward pathways in the striatum. Pathological~     decreases in PFC and striatal function, increases in limbic activity, and disordered~     connectivity between these regions have all been observed in MDD, and the rostral and dorsal~     ACC have been repeatedly linked to antidepressant treatment response.~      Therefore, studying placebo effects offers a window into the functioning of the neural~     circuits that are disturbed in MDD and improve with effective treatment. The goals of this~     study are to determine whether expectancy affects the outcome of antidepressant~     pharmacotherapy and to investigate the neural mechanisms of expectancy effects. These will~     be accomplished by conducting a clinical trial randomizing adult outpatients with MDD to 8~     weeks of treatment in high vs. low expectancy conditions. The high expectancy condition will~     be open administration of citalopram, while the low expectancy condition will be~     placebo-controlled administration of citalopram. The neural mechanisms of expectancy will be~     determined using functional Magnetic Resonance Imaging (fMRI) paradigms to investigate~     treatment activation differences in brain regions associated with placebo effects and MDD.~   "
86956|NCT01919203|"~     This research attempts to find the optimum dose of remifentanil that can prevent the~     unnecessary responses such as coughing, gagging, and movement when LMA is inserted during~     sevoflurane induction in pediatric patients.~   "
86957|NCT01919190|"~     The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use~     and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in~     Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.~   "
86958|NCT01919177|"~     The main objective is to test the hypothesis that inorganic nitrate supplementation will:~     (1) Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator~     reserve during exercise and specifically, the vasodilator response in exercising muscle; (3)~     Reduce arterial wave reflections and arterial load; (4) Improve skeletal muscle~     mitochondrial function in subjects with heart failure with preserved ejection fraction.~   "
86959|NCT01919164|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2~     trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of~     the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the~     efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these~     individuals.~   "
86960|NCT01919151|"~     Prognostic and predictive value of assessing the patients micrometastasis status in blood~     and bone marrow when diagnosed GI cancer. 2 different patient subgroups are currently~     studied, patients with cancer of the pancreas and patients with liver metastasis secondary~     to colorectal cancer.~      Our hypothesis is that patients with detective circulating tumor cells in the blood or~     disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease~     than negative patients. This information may be of therapeutic interest.~   "
86961|NCT01919138|"~     Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care~     Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.~   "
86962|NCT01919125|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and~     tolerability of single-dose administration of IDX719 in participants with normal hepatic~     function and participants with varying degrees of hepatic impairment.~   "
86963|NCT01919112|"~     Swallowing difficulties are common after a stroke and can lead to serious complications like~     pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving~     swallowing in stroke patients.~      Previous investigations have shown that recovery of swallowing functions occurs from~     reorganization (rewiring) of the non-involved cerebral hemisphere. In this study, we~     propose to investigate a new intervention, which combines, swallowing exercises with brain~     stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in~     acute. We will only be enrolling hospitalized stroke patients. We plan to assess the safety~     of this technique in this patient population and also assess its effect on improving~     swallowing functions and swallowing physiology. During this time trial participants will~     undergo standardized swallowing and neurological assessments as well as brain MRI scans.~   "
86964|NCT01919099|"~     Background:~      - The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants~     (allo-HSCT) each year. Many studies already look at different problems that can follow a~     transplant. But there are many types of transplants, diseases, responses, and treatments. An~     organized study of this information could help researchers learn more about how often~     transplant complications occur and what problems they cause. It could also lead to ideas for~     future research. This study will focus on complications thought to be the most significant.~      Objectives:~      - To gather information on the complications that may occur after an allo-HSCT.~      Eligibility:~      - People over 2 years of age currently enrolled in an allo-HSCT study at NIH.~      Design:~        -  Visits for this study will be scheduled along with primary study visits. The number of~          visits will depend on the primary study schedule.~        -  At each visit, participants will answer questions and take physical exams.~        -  The same questions and physical exams will continue for as long as they are in the~          primary study.~        -  In between visits, researchers might call participants to discuss their health. They~          may also discuss the cases with the primary study doctors and other doctors. Primary~          transplant study doctors will make treatment decisions.~        -  When participation in the primary transplant study ends, participation in this study~          will also end.~   "
86965|NCT01919086|"~     The purpose of this study is to see if researchers could get the same good results with less~     toxicity by using this new approach.~      We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given~     together at the same time are effective. Most physicians therefore treat patients with~     multiple myeloma with the 3 drug combination. However, the researchers also know that the~     three drugs given together result in more side effects than when only 2 drugs (bortezomib~     and dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that~     all patients may not necessarily need the three drugs to have good results. In this study,~     the researchers will first treat your disease with bortezomib and dexamethasone. If the~     disease is not well controlled with these 2 drugs, only then the third drug, lenalidomide,~     will be added. By using this sequential approach we may reach the same good results with~     fewer side effects.~   "
86966|NCT01919073|"~     The purpose of this study is to test the intervention using a more rigorous randomized~     controlled trial design in order to demonstrate its efficacy compared to a wait-list~     control, thus ensuring that change in behavior does not occur due to the passage of time~     alone. Using this design will also allow us to improve upon our prior clinical research by~     facilitating obtainment of post-treatment and follow-up data (as families in the~     clinical-only service stop attending treatment when behavior improves, and have often not~     followed-up for booster sessions or measure completion).~   "
86967|NCT01919060|"~     The purpose of the study is to investigate acute non-mechanical lower digestive tract~     disorders should distinguish whether colonic lesions or not in critically ill patients~   "
86968|NCT01919047|"~     This study is to determine the following information.~        1. The occurrence of adverse drug reactions in clinical settings.~        2. Factors potentially impacting safety, effectiveness, and other aspects.~   "
86969|NCT01919034|"~     According to above basic findings, it is important to confirm those results in clinic. In~     this branch, the investigators will use patient control analgesic (PCA) device to~     investigate the consumption of morphine for patients undergoing hepatic surgery.~     Preoperative and postoperative (before and after surgery) blood will be sampling (15cc/time)~     and y liver tissue (10mm3) will be harvested to measure the expression of above molecules~     (TM, IL-20, HD). Pain questionnaire will also be applied to evaluate their pain control~     quality. Certainly, the morphine consumption and results from pain questionnaire will be~     correlated with the molecule amount to figure out possible relationship between morphine~     consumption and those molecules.~      Patients undergoing abdominal surgery and using morphine pain control analgesia (PCA) device~     will be involved. Pre- and Post- operative (after anesthesia and at the end of surgery)~     blood sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above~     protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or~     flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin~     tissue). Patients will be included in this branch to check the correlation between morphine~     consumption and protein expression. Pain questionnaire (BPI, McGill) will be applied for~     pain evaluation. 2-D gel analysis will also be applied to screen further possible molecules.~      Specific aims~        1. To investigate the correlation of morphine consumption and the serum amount of IL-20,~          TM or HD~        2. To investigate the relationship between IL-20, TM, HD amount in liver tissue and~          morphine consumption~   "
86970|NCT01919021|"~     Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on~     quality of life and health care costs. When no structural cause is identified, patients are~     diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of~     stomach function that explain patient's symptoms and establish diagnosis. Another group are~     diabetic patients who can often develop similar symptoms, labelled as diabetic~     gastroparesis. In some cases this is associated with delayed gastric emptying but not all.~      24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish~     normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.~      The utility of 3 different non-invasive investigations will be assessed. At screening the~     nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every~     minute and score symptoms every 5 minutes. The patient continues until they reach the~     maximum tolerated volume.~      Participants will then be randomized to undergo non-invasive imaging on two separate test~     days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with~     the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional~     calories) of known breaking strength. The emptying of the stomach will be visualised with~     the MRI alongside symptom recording.~      Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling~     will allow the rate of liquid and solid meal emptying to be visualised alongside symptom~     recording.~      Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30~     minutes following ingestion of 400ml of milkshake and 12 agar beads.~      Data will be analyzed to assess the association of objective abnormalities of gastric~     function and patient symptoms. Additionally the results of non-invasive imaging by MRI and~     GS will be compared to assess the optimal measurement of gastric function and emptying in~     this clinical scenario.~   "
86971|NCT01919008|"~     This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high~     dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in~     the population was also evaluated.~   "
86972|NCT01918995|"~     This study is to determine the safety, tolerability, and pharmacokinetics of two or three~     repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy~     supine subjects.~   "
86973|NCT01918982|"~     We aimed to see if aortic aneurysms could be followed-up by circulating endothelial~     progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.~   "
86974|NCT01918969|"~     Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been~     shown to be inversely correlated to aortic aneurysm size. However reference values have not~     yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et~     CD34+VEGF-R2+CD14- in healthy men and women blood donors.~   "
86975|NCT01918956|"~     This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch~     will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks)~     compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).~      The primary endpoint of the sudy is the comparison of the proportions of the patients who~     have successfully reached the maintenance dose between the two treatment regimes.~      A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is~     as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with~     PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.~   "
86976|NCT01918943|"~     Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a~     treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and~     degenerative scoliosis.~      Many techniques evolved since then, from wiring, rods, pedicle screws, and recently~     inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods~     for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior~     fusion techniques, two methods of achieving an interbody fusion from a posterior approach~     have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody~     fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more~     common technique, requiring in some cases, complemental posterior fixation with pedicle~     screws, facet screws or interspinous fixation devices like the Aspen device.~      In this study, we address the clinical and radiological outcome of a novel technique using~     standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar~     approach.~   "
86978|NCT01918917|"~     The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to~     levobupivacaine for postoperative analgesia in arthroscopic knee surgery.~   "
86979|NCT01918904|"~     Calcinosis cutis refers to a group of disorders characterized by calcium deposition in the~     skin (1). The disorders are classified according to etiology into the following types:~     dystrophic, metastatic, iatrogenic, and idiopathic (1,2). Dystrophic calcification occurs in~     the setting of varicosities, infection, tumors, and connective tissue disorders (1). The~     connective tissue disorders most commonly associated with calcinosis cutis are systemic~     sclerosis and dermatomyositis, although it has also been reported in patients with systemic~     lupus erythematosus, undifferentiated connective tissue disorder, and mixed connective~     tissue disorder (2). The pathophysiology of calcinosis cutis is not well understood, and~     there is a broad range of severity seen, from benign localized, small nodules to large,~     severely debilitating lesions (2). Although many therapies have been investigated for~     treatment of calcinosis cutis, including calcium channel blockers, colchicine, minocycline,~     intravenous immunoglobulin, and bisphosphonates, results have been mixed at best (2).~     Surgical removal is sometimes feasible in the case of a localized lesion, however,~     recurrence after surgery is common (2).~      Recently, several authors have reported cases of dramatic resolution of dystrophic~     calcinosis cutis lesions with topical sodium thiosulfate preparations (1,3,4). Systemic~     sodium thiosulfate therapy is commonly used to treat calciphylaxis in patients with renal~     disorders with very few adverse events (1). A search of the literature to date yields no~     formal studies that aim to determine whether topical sodium thiosulfate is truly an~     effective therapy for calcinosis cutis. As a result, patients are often treated with~     therapies that are unproven or ineffective and their calcinosis cutis eventually leads to~     significant pain and disability.~      Research Question:~      Does treatment of dystrophic calcinosis cutis with topical sodium thiosulfate result in~     diminution of the lesion and associated pain?~      Objective:~      The objective of this pilot study is to investigate whether topical sodium thiosulfate is an~     effective therapy for calcinosis cutis. This study will also determine the feasibility of~     our protocol and provide information to help direct a future full-scale trial.~   "
86980|NCT01918891|"~     The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the~     effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community~     transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower~     their systolic blood pressure.~   "
86981|NCT01918878|"~     This is a prospective, multicenter, single arm study. The study group will be compose of~     NVAMD patients who had partial or complete failure responding to initial bevacizumab or~     ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study~     groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits.~     Aflibercept will be provided for total period of 24 weeks.~   "
86982|NCT01918865|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo +~     oral antidiabetic drug/s.~   "
86983|NCT01918852|"~     The study is a two-arm randomised phase III trial. Patients will be randomised to receive~     capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the~     investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be~     assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles~     for response. Upon disease progression patients will be treated according to the local~     investigators~   "
86984|NCT01918839|"~     This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI~     Plus as compared to Restylane-L® in correction of nasolabial fold.~   "
86985|NCT01918826|"~     The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases:~     there is no curative treatment at present, on the other hand precautionary measures can be~     taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the~     literature and in our recent study (evaluation of the pain in the disease of CMT - Reference~     center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important~     varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the~     pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous~     neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought~     back collateral effect, used at the same time in the chronic pain and acute since 1960, as~     well for the neuropathic pains that musculo-scrawny. No study was realized this day on the~     use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency~     of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most~     frequent painful location in our recent works.~      The main objective will be to analyze the improvement of the pain of lower limbs, based on~     the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.~      The secondary objectives will be to estimate repercussions on the functional capacities (~     ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global~     impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic~     Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety~     and Depression scale).~   "
86986|NCT01918813|"~     This study was designed to evaluate the effect of a targeted preoperative~     Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction~     (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk~     population undergoing gastroenterological surgery. The primary endpoint was to investigate~     whether the potentially high incidence of MRSA infections in patients with MRSA nasal~     colonization before surgery can be prevented with a PCR-based strategy. The second endpoint~     was to investigate the impact of acquisition of MRSA colonization after surgery on the~     occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection~     is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is~     limited effect in patients with postoperative MRSA acquisition.~   "
86987|NCT01918800|"~     The purpose of this study is to compare two different educational programs for people with~     multiple sclerosis (MS), which is a common and often disabling disease of the central~     nervous system. MS causes many symptoms including difficulty walking, loss of balance or~     muscle coordination, fatigue, numbness and tingling and stiffness. The investigators want to~     determine which program is better at helping improve quality of life and MS symptoms. Both~     programs use material from the National Multiple Sclerosis Society (NMSS). Both programs~     include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4~     VA sites, with about 150 at each site. There will be 10 study visits, all to occur within 11~     months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data~     collection visits. Participants will be randomly (by chance) assigned to be part of either~     group education program. They will have a 1:1 or 50% chance of being in either program. The~     primary outcome will be the Modified Fatigue Impact Scale. Secondary outcome measures will~     be the Multiple Sclerosis Self-Efficacy Scale and changes in medication usage, physical~     activity level and health-related quality of life.~   "
86988|NCT01918787|"~     rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in~     adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is~     effective in improving social ability in adults with autistic spectrum disorder~   "
86989|NCT01918774|"~     In 2010, 11.5% of all Gulf War-II Veterans were unemployed; that figure rose to 15.2% in~     January 2011 and continues to grow as the number of Veterans from recent wars increases~     (United States Department of Labor, 2011; Seal et al., 2009). The prevalence of mental~     illness among Veterans is also notable; estimates range from 31% (Seal et al., 2007) to~     nearly 37% (Seal et al., 2009) for any psychiatric disorder, and over half of these Veterans~     are diagnosed with more than one psychiatric condition (Seal et al., 2007). In addition,~     empirical evidence suggests that some mental disorders are more prevalent in Veterans than~     in the general population (Kessler et al., 2005). Linking unemployment and mental illness, a~     recent study found that 65% of Veterans using VA healthcare were unemployed, and compared to~     employed Veterans, the unemployed were more likely to have depression, bipolar disorder,~     post traumatic stress disorder (PTSD), schizophrenia, or substance use disorders. Vocational~     dysfunction was reported most often in disabled Veterans with schizophrenia, PTSD, and~     substance use disorders (Zivin et al., 2011). Not surprisingly, this study also found that~     unemployed Veterans had significantly lower income than employed persons. Similarly, a large~     study focusing specifically on Veterans with PTSD concluded that vocational dysfunction is a~     notable problem among this group, as they were significantly less likely to be employed~     after participating in VA work programs compared with participants without the disorder~     (Resnick & Rosenheck, 2008). Because most individuals with mental illness desire to work in~     regular competitive employment (McQuilken et al., 2003), the nationwide problem of~     unemployment among Veterans with mental illness is particularly troubling.~      The VA is addressing this need by implementing supported employment (SE), a psychiatric~     rehabilitation approach that provides individual vocational assistance to Veterans with~     mental illness. While the SE model is empirically validated and SE programs have been shown~     to achieve partial success in improving employment outcomes, a sizable proportion of~     individuals, 40% or more, remain unemployed (Bond et al., 2008). A further challenge is job~     retention; Veterans with mental illness who obtain jobs frequently struggle to maintain them~     long-term. Even in the context of high quality, evidence-based vocational services, most~     studies show only modest job retention of a few months (Bond et al., 2008), and~     consequently, frequent job losses and inconsistent vocational functioning remain a~     substantial and unsolved problem.~      Rationale: Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of~     psychiatric conditions (Butler et al., 2006; Wykes et al., 2008); however, its benefit to~     functioning remains less well understood. Work functioning has received little empirical~     attention in the CBT domain. Despite research evidence suggesting that maladaptive thoughts~     about oneself and expectations about the ability to work interfere with work success (e.g.,~     Hoffman et al., 2000; Kukla, Bonfils & Salyers, 2015; Kukla, McGuire, & Salyers, 2015), no~     CBT programs have been developed specifically targeting vocational themes with the goal of~     improving competitive work outcomes. Further, a recent paper outlined needed avenues of~     future study in the SE domain; Drake and Bond (2011) state that cognitive strategies may be~     a fruitful area to develop to help nonresponder consumers with mental illness who struggle~     with vocational dysfunction despite high quality vocational assistance. The goal of the~     current project is to address this gap and the serious problem of unemployment in Veterans~     with mental illness by pilot testing the CBT for work success program (CBTw) and assessing~     key employment outcomes before and after the intervention, and six months after conclusion~     of the intervention.~      Specific Aims:~      Aim 1: Test the preliminary efficacy of the CBTw program on key Veteran employment and~     psychosocial outcomes utilizing a pre/post design.~      Aim 2: Further assess the feasibility of the program, including recruitment, retention~     rates, and program participation rates.~      Aim 3: Gauge effect sizes in preparation for a larger randomized controlled trial examining~     the effectiveness of the CBT program in routine practice settings~   "
86991|NCT01918748|"~     Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke~     patients have not reached their full potential when they are discharged from hospital. It is~     proven that extra training opportunities lead to further improvement. To date, new training~     possibilities, such as robotic techniques for rehabilitation, virtual reality training~     systems and tele-rehabilitation are being developed to aid in the training of stroke~     patients.~      Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive~     6-week technology-assisted training regime, featuring a robotics-based self-adapting arm~     training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and~     arm skill performance in chronic stroke patients with low to moderate proximal~     (shoulder/arm) muscle strength.~      Study design: single arm prospective cohort study. Study population: 16 stroke patients in~     the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the~     arm, having low to moderate proximal (shoulder and arm) muscle strength.~      Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or~     challenges the patient to perform movements of the arm, thereby training motor control and~     co-ordination of the affected arm. Also strength and endurance of arm muscle use may be~     trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend~     training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at~     least half an hour to avoid (general) fatigue and overuse.~      Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the~     start of the intervention, each interspaced by 1 week to assess baseline stability or any~     fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is~     not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training.~     Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling.~     Secondary outcome measures are: motricity index, plate tapping task, active range of motion,~     perceived strength and fatigue.~   "
86992|NCT01918735|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     ascending (increasing) and multiple doses of GWP42006 compared with placebo.~   "
86993|NCT01918722|"~     In order to investigate the time window of acute intracerebral hemorrhage(AICH) by Blood~     Activating and Stasis Dispersing therapy and to verify traditional methods if it would~     influence or enlarge the brain hematoma, test is made by random double-blind controlled.~     Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of~     the therapy lasts two weeks, and the follow up should last three months. The main indexes~     are mortality rate, disability rate and the brain hematoma situation. The review is made by~     the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this~     test.~   "
86994|NCT01918709|"~     Primary objective : To investigate pharmacokinetics after concomitant administration of~     valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in~     healthy male volunteers~      Secondary objective : To investigate safety profiles after the administration of valsartan~     or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in~     healthy male volunteers~   "
86995|NCT01918696|"~     The purpose of this study is to determine whether a computerized intervention designed to~     reduce anger-provoking interpretation biases will reduce suicide risk among individuals with~     elevated levels of trait anger.~   "
86996|NCT01918683|"~     This trial is designed to be the initial prospective pilot investigation of the~     effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver~     transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in~     pre-transplant population have been performed. We propose the trial be conducted as a pilot~     clinical trial with the goal of enrolling 40 patients into each arm~   "
86997|NCT01918670|"~     Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a~     procedure that is currently used for the treatment of symptomatic atrial fibrillation~     patients.~      We have organized a multi-centric national survey of catheter ablation of atrial~     fibrillation in order to have a feedback on the type of procedures being performed and the~     overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.~   "
86998|NCT01918657|"~     The purpose of this research study is to learn about the medical effects, safety, and how~     the Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type~     of immunotherapy involves giving increasing doses of walnut allergen to gradually build up a~     person's tolerance to walnut and at least one other tree nut. The goal of the study is to~     determine whether participants can tolerate (eat) walnuts and at least one other tree nut in~     their diet after stopping the study therapy.~   "
86999|NCT01918644|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy when given together with capecitabine before surgery in treating patients with~     pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be~     able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used~     in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving stereotactic~     body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
87000|NCT01918631|"~     Currently, five nucleos(t)ide analogs are approved for the treatment of chronic hepatitis B,~     namely lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil~     fumarate (TDF). ETV and TDF are recommended as first-line therapy by all regional guidelines~     due to their high anti-viral potency and low risk of inducing resistance.~      ETV monotherapy for chronic HBV infection is highly effective in both HBeAg-positive and~     negative treatment-naïve patients. The cumulative probability of maintained virologic~     suppression with undetectable HBV DNA at year 1, 2 and 3 were 76.5%, 83.0% and 88.3%~     respectively.~      TDF is another potent anti-viral treatment for chronic hepatitis B. Up to 72% and 87% of~     HBeAg-positive and -negative patients achieved undetectable HBV DNA by week 144 of TDF~     monotherapy. It is also effective in patients with prior exposure to other nucleo(s)tide~     analogs. Previous studies demonstrated that TDF can be used as an effective rescue therapy~     in lamivudine or adefovir-treated patients with incomplete virologic response.~      However, the optimal treatment for patients with suboptimal response to ETV is uncertain.~     With this background, we will conduct a randomized controlled trial to evaluate the efficacy~     of TDF switch therapy in patients with incomplete virologic response to ETV treatment.~   "
87001|NCT01918618|"~     Recent experimental and clinical data suggest a benefit of levosimendan on the kidney~     function. Therefore, this retrospective, single center, matched-pairs analysis aimed to~     investigate whether administration of levosimendan was associated with improved renal~     function in cardiac surgery patients.~   "
87002|NCT01918605|"~     The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal~     product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.~   "
87003|NCT01918592|"~     Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack~     accurate imaging technologies in clinical staging and estimation of response to neoadjuvant~     chemotherapy as well as prognostic biomarkers.~      In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer~     prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also~     prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response~     to neoadjuvant chemotherapy.~   "
87004|NCT01918579|"~     Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can~     reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence~     of antibiotic abuse for community acute respiratory infection has been reported. This study~     will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory~     illness at primary healthcare stations reduces inappropriate antibiotic use safely.~      The study will be conducted at ten district health care facilities in Hanoi, Viet Nam.~     Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute~     respiratory infection. Patients will be randomly allocated to the control or the~     intervention arm. Participants in the control group will be treated according to routine~     care. Participants in the intervention arm will have a CRP test, the results of which will~     be available to the health care practitioner to contribute to their diagnosis and treatment~     decisions.~      All patients will be followed-up via telephone call after 14 days. The study will compare~     the proportion of patients in each arm receiving any antibiotics within 2 weeks of study~     enrollment.~   "
87005|NCT01918566|"~     Our objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI. Administration of glucose with and without lactisole and~     exendin as well as fructose is followed by functional brain MRI, and findings are correlated~     with serum GLP-1 levels as an endogenous satiety signal in humans.~   "
87006|NCT01918553|"~     Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised~     countries. There are few epidemiological studies on the incidence of this disease. Studying~     the incidence of AMD in an elderly French population and identifying the predisposing~     factors is very important to allow a major advance in the epidemiological knowledge of AMD.~     This study will contribute to the identification of the clinical, genetic and modifiable~     parameters associated at the risk of developing AMD. This could result in means prevention~     as well as in the identification of subjects as high risk of AMD~   "
87007|NCT01918540|"~     The study aims at comparing the effect of hollow or solid centralizer designs on the long~     time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless.~     In a prospective, controlled and randomized study comprising two groups of 30 patients/hips~     each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In~     completion general health questionnaires as well as hip specific scoring instruments will be~     used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the~     different centralizers will result in different migration patterns of the stems, which might~     affect the risk for late aseptic loosening.~   "
87008|NCT01918527|"~     The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy~     + operation with the standard treatment of locally advanced colon cancer, which is operation~     + 8 cycles of (adjuvant) chemotherapy.~      Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the~     operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.~   "
87009|NCT01918514|"~     Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain~     relief.~      In the pain clinic the investigators perform different injections as the standard treatment~     for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine~     with or without Steroids (Depo-medrol) is used for these injections.~      The investigators' goal is comparing pain control in different groups adding the magnesium~     sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong~     the duration of analgesia and reduce the amount of narcotic dose.~   "
87010|NCT01918501|"~     Background: Multiple sclerosis (MS) is a complex and multifactorial neurological disease~     characterized by infiltration of immune cells and progressive damage to myelin and axons.~     Remyelination, the generation of new myelin in the adult nervous system, is an endogenous~     repair mechanism that restores function of axons. Neurons require considerable energy for~     their activities, including synaptic neurotransmission, and hence have significant numbers~     of mitochondria. Unlike other cell types that are able to utilize glycolysis as an~     alternative energy source, glycolysis in fully differentiated neurons is basically~     suppressed to maintain their antioxidant status. This property makes neurons highly~     vulnerable to ATP deficiency, and may be a factor in the susceptibility of neurons to cell~     death. Mitochondria provide cellular energy by converting oxygen and nutrients into~     adenosine triphosphate (ATP); and reflect local metabolic needs and via oxidative~     phosphorylation. Nervous tissues contain about 70% lipids of their dry weight, and around~     40% of these lipids are polyunsaturated fatty acids (PUFAs).~      Goal: Understanding the relationship between blood composition, mitochondria role and~     clinical status.~      Here, we will examine expression levels of different fatty acids in the blood and monitor~     mitochondrial transmembrane potential as marker for the mitochondria general function.~      Hypothesis: Remyelination efficiency in MS is likely mediated by many factors, besides~     reducing inflammation. Remyelination may not be achieved correctly /sufficient in MS~     patients due to nutrition low content causing mitochondrial dysfunction and/or due to fatty~     acid molecules deficit unable to create a new myelin layer.~   "
87011|NCT01918488|"~     The purpose of the study is to determine whether a diuretic drug called amiloride is capable~     of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients~     with kidney disease. Our hypothesis states that amiloride is capable of reducing blood~     pressure in these patients and thus decrease the cardiovascular risk associated with~     diabetic kidney disease.~   "
87053|NCT01917942|"~     This is a two arm randomised phase III trial which will evaluate prospectively the benefits~     of humidification in patients receiving radiotherapy / chemoradiation for head and neck~     cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use~     of humidification with radiotherapy can be considered an extension of the general principle~     of moist wound care in wound management.~   "
87012|NCT01918475|"~     Carbetocin is a synthetic analogue of the hormone Oxytocin and is routinely used in~     obstetric anesthesiology to control uterine bleeding after cesarean section. As an~     incidental finding, women who received carbetocin had less pain after cesarean section than~     women who had received Oxytocin. Carbetocin may therefore have an analgesic effect.~      The present study examines this analgesic effect using different sensory tests, e.g.~     pressure, heat, cold and electrical pain before and after administration of carbetocin in~     healthy male volunteers. Any changes in these sensory tests might be indicative of an~     analgesic property of carbetocin.~   "
87013|NCT01918462|"~     The purpose of this study is to investigate the production, effects and interactions of the~     hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.~   "
87014|NCT01918449|"~     The objective of the study is to compare the results of a coordinated and interactive~     program for the treatment, monitoring and control of patients with a moderate-severe~     diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure~     (CPAP), with the currently established situation.~      Methodology: Equivalence randomized comparative study . It will include patients with~     diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment~     with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida~     (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the~     Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis~     has been made and it was indicated that treatment with CPAP. Patients Will be carried out in~     both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6~     months. Primary outcomes: number of hours of use per day (according to the accountant of the~     CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary~     outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP~     treatment. It will be collected demographic ,clinics and anthropometric variables. At the~     end of follow-up primary and secondary outcomes will be compared between two groups.~   "
87015|NCT01918436|"~     Background:~      TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological,~     neurocognitive intervention program targeted preschool children with ADHD developed by~     Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this~     program lies in the concept, based on stimulating neurocognitive growth through focused~     physical activity and play (Halperin et al.; 2011, 2012, in press).~      Teams hypotheses:~      TEAMS is based on the notions that:~        1. The behavioural manifestations of ADHD are the result of deficient neural networks that~          affect a wide array of neurocognitive and behavioural processes which are not~          necessarily identical in all children with the disorder.~        2. Neurodevelopment is sensitive to and can be positively affected by appropriate~          environmental influences.~        3. Effective environmental stimulation will be best achieved within a social context.~        4. The engagement of the child in the core activities of the treatment must be~          intrinsically rewarding (i.e., fun) in order to facilitate compliance of the~          intervention.~      The initial research by Halperin et al. (2012)indicated significant improvement in ADHD~     severity from pre- to post-treatment, which also persisted 3 months later.~      Objective: The aim of this study is, through a randomized controlled trial (RCT), to~     validate the TEAMS treatment program in a clinical setting in Denmark.~      Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as~     primary diagnosis are offered participation in the RCT study of the TEAMS program. The~     control groups receive the standard treatment program, outlined by the clinical guidelines~     of Region Zealand. The intervention groups participate in eight weekly group sessions~     consisting of separate parent- and children's groups.~      In the child group the children are introduced to games that are designed to enhance~     inhibitory control, working memory, attention, visuospatial abilities, planning, and motor~     skills. The parent group consists of psychoeducation and instructions in how to encourage~     playing these games with their children and how to support the child's development.~   "
87016|NCT01918423|"~     Children born to obese women are at risk of increased adiposity and later adverse metabolic~     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP~     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant~     women were randomized to either lifestyle intervention or routine obstetric care. This~     present study follows the children until 3 years of age. We have the hypothesis, that the~     intervention during pregnancy results in a lower degree of adiposity and metabolic risk~     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including~     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring~     metabolic markers.In addition, we have included an extra control group of children born to~     normal weight women, who were not part of a lifestyle intervention program during pregnancy.~     We have the hypothesis that the children of the normal weight women have a better metabolic~     profile than the children born to the obese women.~   "
87017|NCT01918410|"~     Contact lens induced dry eyes leads to lens intolerance and discontinuation. Incidence of~     dry eye in contact lens wearer is significantly higher in Asian population compared to other~     ethnic group considering Asian has lower tear break up time. Disruptions of tear integrity~     in contact lens wearer will further exacerbate the condition. Factors for successful contact~     lens fitting derive from the biocompatibility of lens material, lens design and stability of~     tear film in front of the contact lens. This study aim to investigate the efficacy of a~     novel daily disposable contact lens with zwitterionic material that contains alginic acid~     which act as a moisturizing agent. The improved lens material may likely improve the comfort~     and treat symptomatic wearers.~   "
87018|NCT01918397|"~     Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around~     the world. This type of tuberculosis is very difficult to treat, and many patients die from~     it. Drugs of the fluoroquinolone class are very important for treating MDR-TB, but the best~     dose of one of the most effective fluoroquinolones, levofloxacin, is not known. This~     application proposes a study to determine the best dose of levofloxacin to use in treating~     MDR-TB. 120 patients will receive their usual treatment, plus levofloxacin at one of four~     doses. The study will be performed in Peru and in South Africa, where MDR-TB is common.~   "
87029|NCT01918254|"~     This multicenter, open-label dose-escalation study with an extension phase will evaluate the~     safety and pharmacokinetics of RO5479599 in combination with pertuzumab and paclitaxel in~     participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of~     participants will receive escalating doses of RO5479599 intravenously (IV) every three weeks~     (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg~     IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of~     dose-limiting toxicity period (21 days), the study will be conducted in two extension phase~     cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon~     completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
87030|NCT01918241|"~     This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a~     single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.~   "
87019|NCT01918384|"~     Duchenne Muscular Dystrophy (DMD) is inherited neuromuscular disorders due to mutation in~     the gene that encodes critical muscle protein called dystrophin. Currently, there is no~     effective treatment option for the disease. A pharmacological approach by promoting mRNA~     translation regardless of the presence of premature stop codons by nonsense mutation, called~     the readthrough strategy, has been developing recently for DMD with nonsense mutation.~     NPC-14 is a candidate compound for the readthrough strategy, since effective readthrough~     activities were demonstrated in nonclinical studies. This study is a phase II study designed~     to assess safety, tolerability, and efficacy of NPC-14 in ambulant DMD patients with~     nonsense mutation that were confirmed by whole genome analysis. These goals will be~     accomplished by monitoring adverse events by physical examination, cardiac, pulmonary,~     auditory, balance, and laboratory tests as safety endpoints, and dystrophin expression in~     muscle biopsy as primary efficacy endpoint, muscle function (NSAA, timed test, muscle~     strength (QMT, MMT) , dairy activities by lifecorder), and biomarkers as secondary efficacy~     endpoints. The study is a randomized, double blind, placebo-controlled study in 21 DMD~     patients. After screening, eligible patients are allocated dynamically to weekly NPC-14 or a~     placebo (saline) in a 2:1 ratio and will receive study drugs for 36 weeks.~   "
87020|NCT01918371|"~     This retrospective data review study will evaluate anti-VEGF injections for retinal vein~     occlusion (RVO) or diabetic macular edema (DME).~   "
87021|NCT01918358|"~     To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab~     160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg~     and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers~   "
87022|NCT01918345|"~     Mothers with previous gestational diabetes mellitus (GDM) represent a population at higher~     risk of future Type 2 diabetes mellitus (T2DM), which is preventable through lifestyle~     modification. Yet, no formal prevention programs exist for this population. The postpartum~     period is a particularly vulnerable period for weight gain and unhealthy lifestyle in new~     mothers due to their competing demands of childcare and breastfeeding. This important time~     period may thus represent a 'window of opportunity' for women with previous GDM, whereby~     interventions to improve their lifestyle can be offered. Eligible women will be recruited~     during pregnancy from four hospitals and invited to participate in a home-based lifestyle~     intervention program starting from three to six months postpartum. This pilot study will~     investigate the feasibility and effectiveness of a physical activity and diet intervention.~     It will also explore the relationship between behaviour change and metabolic markers of T2DM~     in this high-risk population. Investigators hypothesize that the ADAPT-M program will be~     feasible and will be associated with an improvement in metabolic T2DM markers, as well as a~     high rate of satisfaction, adherence, and effectiveness.~   "
87023|NCT01918332|"~     This study aims to evaluate the efficacy and safety of the coadministration of valsartan~     (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component~     administered alone in patients with hypertension and hyperlipidemia.~   "
87024|NCT01918319|"~     Children born to obese women are at risk of increased adiposity and later adverse metabolic~     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP~     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant~     women were randomized to either lifestyle intervention or routine obstetric care. This~     present study follows the children until 3 years of age. We have the hypothesis, that the~     intervention during pregnancy results in a lower degree of adiposity and metabolic risk~     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including~     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring~     metabolic markers.~   "
87025|NCT01918306|"~     This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K~     inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine~     how well the combination of GDC-0941 and cisplatin work in treating patients with androgen~     receptor negative triple negative metastatic breast cancer. Patients will be randomized to~     receive cisplatin alone or cisplatin with GDC-0941 in the phase II portion. Those receiving~     cisplatin alone can receive GDC-0941 upon progression of their disease. Cisplatin is a~     chemotherapy which has been shown to be effective in treating triple negative breast cancer.~     Preclinical studies show that adding a PI3K inhibitor such as GDC-0941 to cisplatin may be a~     more effective treatment for breast cancer.~   "
87026|NCT01918293|"~     Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to~     inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough,~     wheezing and severe life-threatening attack and lower quality of life. In addition, it make~     large amount of socioeconomic loss as about 3.7 billion US dollars.~   "
87027|NCT01918280|"~     Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn~     males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly~     non-mosaic KS was considered as a model of a complete male infertility although few KS~     (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the~     possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than~     some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI).~     Since 1997, more than one hundred births are described.~      As some studies shown a decrease of successful sperm retrieval with the increasing of age,~     we plan to compare the potential of sperm retrieval between two groups adult (23-55 years)~     and young after the onset of puberty (15-22 years). The study will be performed by~     searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular~     biopsy if the azoospermia is confirmed on semen analyses.~   "
87028|NCT01918267|"~     This non-interventional, observational, open-label multi-center follow-up study of patients~     from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of~     starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in~     patients early in the disease followed by treatment according to standard of care in routine~     clinical practice in a three year follow-up, independently of what treatment the patient~     will be receiving.~   "
87031|NCT01918228|"~     RCT study of the effect of an educational-based intervention on low back pain-related~     outcomes concerning beliefs and behaviour.~   "
87064|NCT01917799|"~     Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in~     patients with a history of recurrent miscarriages.~   "
87032|NCT01918215|"~     Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention~     implantable defibrillator (ICD) in patients with left ventricular ejection fraction less~     than 35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a~     substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who~     succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these~     patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that~     these patients have ventricular scar and/or replacement fibrosis as a substrate for their~     malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify~     and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement~     myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).~      Methods/Design: A multi-centre randomised controlled trial in which 428 patients with~     mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular~     scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or~     implantable loop recorder (ILR) insertion and are followed up for 3 years.~      Potentially eligible patients will have a screening CMR and will be enrolled into the device~     arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do~     not have ventricular scar/fibrosis will be followed up in an observational registry, and~     will not be randomised.~      In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in~     Europe.~      The primary hypothesis is that among patients with mild-moderate left ventricular systolic~     dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a~     conservative strategy of standard care.~   "
87033|NCT01918202|"~     This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography~     after a single dose of PF-02545920 in Healthy male volunteers.~   "
87034|NCT01918189|"~     The purpose of the proposed project is to develop and test how well an internet-based~     behavioral pain self-management program, the Pain EASE program, can be used for treating low~     back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain~     EASE program will also be examined. Behavioral interventions such as exercise and cognitive~     behavior therapy are known to be effective for low back pain but are often not readily~     available or easily accessed. Veterans will be able to access the Pain EASE program via~     their computer with an internet connection, which will increase access to this type of~     treatment. Study participants will receive 10 weeks of access to the Pain EASE program,~     which will teach them pain coping skills to manage their low back pain. The primary outcome~     is pain-related functional interference.~   "
87035|NCT01918176|"~     Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of~     Palbociclib in absence and presence of prior administration of proton pump inhibitor~     Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of~     Rabeprazole might affect the absorption process of Palbociclib.~   "
87036|NCT01918163|"~     Some animal studies revealed that the pomegranate juice may improve sperm quality in terms~     of concentration, motility and morphology, as well as in fertilization rate.~      Minor data is available regarding the influence on male sperm.~   "
87037|NCT01918150|"~     The purpose of this study is to compare the effectiveness and safety, at 24 months, of the~     TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an~     indication for these stents among 40% of which present an acute coronary syndrome (ACS).~   "
87038|NCT01918137|"~     The deep fried chocolate bar is a snack that the international community strongly associates~     with Scotland. It has previously been cited as being a symbol of all that is wrong with the~     high-fat, high-sugar Scottish diet. Despite the snack's reputation, no medical research has~     been performed to examine the effects of consuming a deep fried chocolate bar on the human~     body.~      In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of~     cardiovascular disease, but its effect on cerebral blood flow has yet to be directly~     assessed.~      This study will focus on the potential (patho)physiological cerebrovascular effects of the~     deep fried chocolate bar and porridge. The research question to be addressed in this study~     is Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral~     blood flow and cereborvascular reactivity in healthy adults?~      To assess the acute effects on eating either food on blood flow through the largest artery~     in the brain, the investigators will give healthy volunteers one regular-sized deep-fried~     chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will~     be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs~     who will visit twice, consuming a different food on each visit.~   "
87039|NCT01918124|"~     This phase II clinical trial was designed to assess the feasibility, safety, toxicity,~     recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant~     radiation for patients with high-risk endometrial cancer.~   "
87040|NCT01918111|"~     1. (RENEWAL-EXERCISE trial) The investigators hypothesize that the increased sympathetic~          nervous system activation that is associated with resistant hypertension is a major~          contributor in the pathogenesis of exercise diastolic dysfunction and that modulation~          of the sympathetic nervous system activity with radiofrequency ablation of the renal~          artery sympathetic nerve fibers delivered via a treatment catheter, will have a~          significant effect on the diastolic function that is beyond BP-lowering effect.~        2. (RENEWAL-REGRESSION trial) The major cause of mortality and morbidity in hypertension~          is atherosclerotic cardiovascular disease. the significant decrease in the sympathetic~          nervous system activation after renal sympathetic denervation will contribute to~          regression over and beyond it's effect of blood pressure reduction.~        3. (RENEWAL-PREDICT trial) No data exists regarding the tests or methods predicting the~          successful renal denervation causing the effective reduction of BP. For these, the~          investigators sought to perform the new tests such as adenosine infusion test during~          procedure and skin sympathetic activity measurement before and immediate post-procedure~          (detailed explanation provided in section of Methods) and then evaluate the association~          between these tests and reduction of BP following procedures.~   "
87041|NCT01918098|"~     To determine the improvement in symptoms of constipation in subjects receiving treatment~     with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged~     release tablets (OXY) based on the Bowel Function Index (BFI)~   "
87095|NCT01917396|"~     The researchers investigate that use of preoperative enema to the effect postoperative bowel~     gas passage.~   "
87043|NCT01918072|"~     VA community-based outpatient clinics (CBOCs) typically serve only a small number of women~     Veterans, and generally do not have the women's health care resources that are available in~     larger settings. Women Veterans using these sites for primary care must sometimes travel to~     other sites to receive women's health care. That can create travel burdens, reduce~     continuity of care, and negatively affect patient outcomes. To address this, VA is~     implementing a clinical operations innovation that supports women's primary care providers~     with a technology-based intervention that combines interactive communication with women's~     health specialists and ongoing education. This research study is evaluating the~     implementation and effects of this women's healthcare delivery innovation. Findings from~     this research will inform VA women's health clinical practice and education, and will~     advance science in delivering technology-supported non-face-to-face care that is applicable~     to other clinical conditions and patient populations.~   "
87044|NCT01918059|"~     This project is a randomized, controlled trial investigating wound cosmetic appearance after~     repair of traumatic lid lacerations with three different approaches to skin closure:~     absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken~     at two intervals after repair and later blindly assessed using standard cosmetic assessment~     scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in~     across all three treatment arms.~   "
87045|NCT01918046|"~     This is a single-center, prospective sample collection study. Samples will be used to~     establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the~     early diagnosis of acute renal injury (AKI) following cardiac surgery.~   "
87046|NCT01918033|"~     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese~     participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine~     is superior to placebo after 2 weeks of treatment with regard to change from baseline in~     Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.~   "
87047|NCT01918020|"~     Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative~     with the goal of improving the health and wellbeing of low income families. University of~     Minnesota Extension every year offers nearly 4000 educational events, serving approximately~     70,000 Minnesotans through the program. Extension is conducting an impact study to determine~     program effectiveness and assess sustained changes of participants and their families that~     can be directly attributed to programming on a larger and methodically sound scale.~   "
87048|NCT01918007|"~     Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during~     sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and~     apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result~     from many different abnormalities including large adenoids and tonsils or obesity.~      Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high~     carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated,~     complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii)~     central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv)~     elevated blood pressure.~      Overnight polysomnography (PSG) is considered the gold-standard method for defining severity~     of obstructive SDB and subgroups of children with snoring who should be treated. However,~     PSG is a labor-intensive, time-consuming and expensive diagnostic method, which is not~     available in many community settings. Thus, there is an urgent need for developing~     easy-to-use and low-cost diagnostic methods which can be used to determine severity of~     obstructive SDB and define subgroups of children with snoring and large adenoids and tonsils~     who will benefit from adenotonsillectomy (AT).~      Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring~     of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently~     accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of~     hemoglobin).The hypothesis of this research project is that subgroups of children with~     snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by~     nocturnal pulse oximetry will benefit from AT in a community setting.~   "
87049|NCT01917994|"~     Retention in care and virologic suppression are the key final steps of the HIV treatment~     cascade. Poor or intermittent retention has been associated with later initiation of~     antiretroviral therapy, virologic failure, and death. Regular HIV care has also been~     associated with a decrease in HIV transmission risk behavior. Despite the proven health and~     prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the~     United States are estimated to meet current retention in care standards and even fewer -~     only about 25% - are estimated to be virologically suppressed.~      The Behavioral Model for Vulnerable Populations provides a useful framework for~     understanding broad areas that may impact adherence to care and treatment. Individual-level~     domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support,~     positive affect), and need (e.g., co-morbidities) factors, and structural domains include,~     for example, features or the clinic and the provider-patient relationship.~      Short message service (SMS) technology represents a new and exciting tool to help retain~     HIV-infected patients in care and treatment. SMS interventions have been deployed~     successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan~     Africa, where two randomized trials have showed clear benefits. A pilot study conducted in~     our clinic suggests that use of SMS messages to promote adherence to care and treatment in~     the urban HIV-infected poor is both feasible and acceptable.~      The investigators believe that combining SMS technology with content-specific messages~     designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations~     can improve retention in care and virologic suppression for an urban public hospital~     population living with HIV, thus the investigators propose the following specific aims.~      Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves~     virologic suppression [primary outcome] and retention in care [secondary outcome] for a~     vulnerable urban HIV-infected population through a randomized trial of this technology~     compared to SMS appointment reminders alone. Retention in care will also be analyzed as a~     mediator of virologic suppression. Exploratory outcomes include time to virologic~     suppression, sustained virologic suppression, emergency department utilization and~     antiretroviral adherence, as well as levels of depression, positive affect, social support~     and empowerment.~      Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically~     on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of~     patient use of this technology, and; 3) the preferred frequency and content of intervention~     messages.~      Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.~   "
87050|NCT01917981|"~     This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm~     Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting~     more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard'~     for arrhythmia detection.~   "
87051|NCT01917968|"~     The purpose of this study is to compare transvaginal mesh repair to traditional native~     tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.~   "
87052|NCT01917955|"~     The purpose of this prospective single-center trial is to compare the safety and diagnostic~     value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal~     echocardiography in patients with acute ischemic stroke.~   "
87054|NCT01917929|"~     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical~     evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a~     cementless application in a consecutive series of patients who meet the eligibility~     criteria. The success rate of the Secur-Fit Advanced femoral stem, defined as absence of~     stem revision for aseptic loosening or femoral fracture, is expected to be no worse than 99%~     at 5 years postoperative with a non-inferiority margin of 2.5%.~   "
87055|NCT01917916|"~     Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising~     doses in healthy Asian male volunteers.~   "
87056|NCT01917903|"~     This study will evaluate gait when individuals with Parkinson's disease (PD) are walking~     while talking to see how walking changes when challenged to perform a functional cognitive~     task simultaneously. By looking at walking alone and walking with varying cognitive loads~     the investigators will be able to determine motor and cognitive factors vulnerable to~     interference in PD. Each is important to understand so that training can address components~     of walking that become impaired when someone is distracted by a common cognitive task and so~     that the intensity of treatment matches the level of task difficulty. Using this initial~     data, the investigators will establish a protocol to improve walking taking into account the~     unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems~     with memory and attention. The investigators will evaluate the potential for this treatment~     to improve walking and improve or maintain cognitive abilities necessary to multitask.~   "
87057|NCT01917890|"~     Prostate cancer is the second most incident cancer among male population worldwide.~     Radiation therapy by itself or along with surgery and chemotherapy are the main treatments~     for prostate cancer however prostate cancer cells are only modestly responsive or even~     unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo~     studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial~     has been done in this area and it is not yet known whether radiation therapy is more~     effective with or without curcumin supplements in treating patients with prostate cancer.~   "
87058|NCT01917877|"~     Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced~     pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not~     only compromise cancer treatment, but also influence patient's life qualities and even~     death. there are no specific treatment modalities for this treatment-induced complication.~     Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and~     pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients~     will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by~     Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone.~     The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before~     treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30~     cases.~   "
87059|NCT01917864|"~     The purpose of this study is to evaluate the utility of a specialized iPad application~     designed to treat difficulties with intonation (e.g., melody in voice) in children with~     autism spectrum disorders (ASD) and other communication disorders.~   "
87060|NCT01917851|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
87061|NCT01917838|"~     The goal of this two-year R34 treatment development grant is to develop a mobile health~     (mHealth) application that will both advance theory in and clinical practice of homework~     (HW) implementation.~      HW can be described as between-session exercises where the client practices specific skills~     learned within-session in order to promote skill acquisition, which ultimately leads to~     improved acute- as well as longer-term therapeutic benefits on targeted outcomes,~     generalization of treatment effects and maintenance of treatment gains. Despite data~     demonstrating that HW is critical to achieving maximal benefits from evidence-based~     treatments, very little theory-driven approaches have been conducted focusing on improving~     the HW process. Through utilizing self-determination theory as a guiding framework and~     integrating principles from the field of gamification and goal-setting, the aim is to~     develop a two-component mHealth HW application (My MFG).~      The first component focuses on delivering HW via a highly engaging, multiplayer,~     interactive, cooperative, and skill-building game platform aimed at improving the Design~     and Do process of HW. The second component focuses on targeting factors putatively related~     to poor HW implementation within the Do process.~      The process of the development of My MFG will be guided by the clinic and community~     development model and iterative software development process to maximize the feasibility and~     sustainability of My MFG within practice settings often characterized by limited resources.~     Findings from this study have broad implications for evidence-based treatments for youth and~     adult mental health disorders that emphasize HW as the link between treatment and~     improvements in targeted outcomes.~   "
87062|NCT01917825|"~     The primary objectives of this clinical trial are to investigate the pharmacokinetics and~     safety of MDT-15 pellets in escalating sequential doses administered to different cohorts.~     Preliminary efficacy data will also be collected for assessment.~   "
87063|NCT01917812|"~     Despite their importance, health-related behaviors are hard to change. Among behaviors,~     physical activity is associated with protection from multiple diseases. People who are~     physically active have lower risk for heart disease, stroke, type 2 diabetes, depression,~     and some cancers with associated dose-dependent reductions in cardiovascular and all-cause~     mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary~     work behavior in industrialized nations is likely a contributor to this problem.~      Current low-technology strategies for encouraging lifestyle change are disappointingly~     ineffective and are highly resource intensive. Systematic reviews of the literature show~     mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence~     for text messaging in preventive health care. However, prior studies have not integrated~     digital activity tracking with mobile phone text messaging feedback.~      Given 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this~     represents a potentially widely applicable avenue for therapeutic intervention. There is~     growing interest in leveraging mobile health (mHealth) technologies to improve health~     behaviors in the general population. The investigators propose to conduct a blinded,~     randomized mHealth trial of digital activity tracking and smart texting to promote physical~     activity.~   "
87065|NCT01917786|"~     Various medications used in anesthesia have been implicated in the prolongation of QT~     interval. Recently, there has been an increase in the use of dexmedetomidine in patients~     presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic~     properties. It has several desirable properties including minimal respiratory side effects~     as well as the ability to decrease intraoperative and postoperative analgesic requirements.~     In many of the patients who present for routine surgical procedures, dexmedetomidine is a~     common component of their anesthetic care. This is a study to assess the effects of~     dexmedetomidine on the QT interval in children presenting for surgery.~   "
87066|NCT01917773|"~     The research study is designed to test how a medication called octreotide affects the~     motility (contraction or squeezing) of the colon (large intestine). Investigators are~     investigating whether octreotide can increase contraction and movement in the colon.~   "
87067|NCT01917760|"~     The purpose of this study is to determine upon administering GABA orally to a person how it~     is absorbed, distributed, as well as the drug's pharmacological effects on the body such as~     glucose levels, serum C-peptide and/or insulin levels (referred to as~     pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to~     address these questions.~   "
87068|NCT01917747|"~     Hearing loss is the most common sensory congenital disorder and this condition is~     diagnosable and treatable. Children that are born with hearing loss have to undergo several~     hearing tests to diagnose the condition and many families are delayed in receiving this~     testing or never obtain the needed testing. This research employs a new method for helping~     children with hearing loss receive timely care by using a patient navigator, who is someone~     who teaches and provides emotional/social support for the families of these children. The~     hypothesis of this study is that a patient navigator will hasten the timing of pediatric~     audiological testing, improve compliance with scheduled appointments, and expand parental~     knowledge of pediatric hearing loss.~   "
87069|NCT01917734|"~     The purpose of this study is to assesses the effectiveness of an integrated model for the~     management of severe acute malnutrition (IM-SAM) in India comprising facility- and~     community-based care and using locally-adapted protocols~   "
87070|NCT01917721|"~     Kawasaki disease (KD) affects infants and young children causing inflammation of the skin~     and blood vessels including the coronary arteries of the heart. Despite the currently~     available therapy, about one third of children develop enlargement of the coronary arteries~     that can lead to serious complications such as coronary artery stenosis, heart attack and~     even death.~      Kawasaki disease is the most common heart disease in children in the USA and it is~     especially common among the children of Hawaii. Every year, 50-90 children are diagnosed~     with KD in Hawaii and unfortunately there is no medication available to successfully prevent~     coronary artery damage in a subset of cases.~      During the first few weeks of the illness, cells of the immune system attack the coronary~     arteries and release a special substance (MMP) that is responsible for the coronary artery~     enlargement. There is a common antibiotic, doxycycline that can specifically block the~     action of this special substance (MMP). Research done on animals with KD showed that~     doxycycline was able to block this special substance and prevent enlargement of coronary~     arteries. Research in adults with enlargement of the main artery in their abdomen also~     showed that doxycycline may improve the outcome. Based on these studies doxycycline may be a~     promising therapy for children with KD, who develop enlargement of the coronary arteries.~      The investigators' proposed research study will assess the usefulness of doxycycline in~     preventing the progressive enlargement of coronary arteries in children with KD. The~     investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in~     preventing coronary artery enlargement. The investigators will treat 25 children with KD and~     enlarged coronary arteries for two weeks with doxycycline and assess the change in coronary~     arteries as well as the blood levels of the special substance (MMP). If doxycycline proves~     to be beneficial in this small study, the investigators are going to design a large research~     study involving multiple institutions on Hawaii and the mainland and will recruit more~     children to be certain about the value of the proposed treatment. The investigators'~     proposal may change the treatment protocol of KD and could present a possible treatment for~     children with enlarged coronary arteries preventing potentially devastating consequences.~   "
87071|NCT01917708|"~     This is a single arm phase I study to assess the tolerability of abatacept when combined~     with cyclosporine and mycophenolate mofetil as graft versus host disease prophylaxis in~     children undergoing unrelated hematopoietic stem cell transplant for serious non-malignant~     diseases as well as to assess the immunological effects of abatacept.~   "
87072|NCT01917695|"~     The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo~     irradiation in carcinoma cervix and to compare its results with the concurrent chemo~     irradiation in terms of overall survival, disease free survival and quality of life.~   "
87073|NCT01917682|"~     To collect data on the routine patterns of use, safety and effectiveness, including the~     clinical and technical performance of the CorPath 200 System, in the delivery and~     manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.~   "
87074|NCT01917669|"~     The purpose of this research is to better understand how calcium and glucose may play a role~     in people developing diabetes. By doing this study, the investigator hopes to learn whether~     abnormal calcium and glucose responses in skin biopsies from healthy patients and patients~     with Type 2 diabetes can identify and predict patients at greatest risk for later~     complications.~   "
87075|NCT01917656|"~     This trial is conducted in Africa and Asia. The aim of the trial is to investigate the~     efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with~     metformin during Ramadan in subjects with type 2 diabetes (T2DM).~   "
87076|NCT01917643|"~     This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC)~     and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.~   "
87077|NCT01917630|"~     To determine the effects of 12 weeks administration of different dose levels of ALV003 on~     the mucosal lining of the small intestine and symptoms in celiac disease patients.~   "
87078|NCT01917617|"~     The objective of this study is to evaluate the safety and feasibility of oral rehydration~     therapy for short hydration in patients with biliary tract cancer who will undergo the~     chemotherapy including gemcitabine and cisplatin.~   "
87079|NCT01917604|"~     To test the null hypothesis that there are no differences in the outcomes between using an~     open or closed surgical method to expose canines that have become displaced in the roof of~     the mouth.~   "
87080|NCT01917591|"~     The objective is to determine, if healing of punch biopsy wounds treated with the fish skin~     derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig~     intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of~     erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4~     weeks after start of treatment~   "
87096|NCT01917383|"~     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy~     and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to~     timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary~     open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic~     solution 0.005% once every evening (QPM).~   "
87081|NCT01917578|"~     The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC~     has been associated with significantly higher ipsilateral breast tumor recurrences.The~     accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of~     IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical~     trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3~     cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and~     three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective~     is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of~     the primary tumor after NAC.~   "
87082|NCT01917565|"~     The investigators hypothesize that when used by experienced anesthesiologists, Airtraq~     laryngoscope will increase the first-attempt success rate with shorter intubation times and~     more stable hemodynamic parameters.~   "
87083|NCT01917552|"~     multi-center, prospective, randomized, open-label phase III~   "
87084|NCT01917539|"~     Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing~     symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian~     gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The~     uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin~     telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e.~     redness, burning sensation) and particularly if not used properly, the potential to cause~     burns, blistering, scarring, and pigmentary changes.~   "
87085|NCT01917526|"~     After general anesthesia, there are the risks for airway obstruction, hypoventilation,~     atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement~     in PACU seems necessary.~      This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula~     at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the~     2 methods can equally provide effective oxygen supplement to prevent anesthesia-related~     hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more~     comfortable to patient.~   "
87086|NCT01917513|"~     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition~     colonoscopy with that of standard high definition colonoscopy~   "
87087|NCT01917500|"~     The objectives of this clinical trial is to validate a S/W application to compare the~     calculations of Hemodynamic parameters like Continuous blood pressure (BP) and Continuous~     cardiac output (CO). This Hemodynamic parameters are computed from Pulse Oximeter~     (PhotoPlethysmograph or PPG) signal with results obtained by NIBP intermittent measurements~     and Echocardiography. The first phase of the study will be done on 10 patients of the~     Cardiology dept.- Cardiac ICU, that have routine measurements of BP and CO using~     Echocardiography.~      The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the~     data and a Smartphone S/W application that serves as the Hemodynamic calculator. The S/W~     application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the~     PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is~     transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.~      The Post-processing uses wavelet signal processing to estimate and display certain~     Hemodynamic parameters like (Blood Pressure) BP and CO in a continuous and graphical way on~     a standard Android Smartphone. In addition to the standard heart rate and SpO2, the~     application displays the measured PPG signal and estimated continues BP and CO.~      HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac~     Output component and the resistance component in a mobile wearable device. Differentiating~     between these 2 components can play a major role in helping the doctor to understand the~     effect of cardiovascular medications and Lifestyle interventions.~   "
87088|NCT01917487|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
87089|NCT01917474|"~     Headache is a frequently disabling disorder, which occurs in about 30% of the adult~     population, particularly in overweight/obese women. Aim of the study is to modify the~     nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a~     normal lipid diet on the incidence and severity of migraine crises. Moreover vascular~     reactivity will be evaluated in a randomly selected subgroup of patients. This randomized,~     cross-over intervention trial will be performed in about 150 patients, affected by migraine.~     Adherence to the diet, particularly regarding energy intake, percent of energy from lipids,~     carbohydrates and proteins will be carefully assessed at baseline and during the 2~     intervention periods~   "
87090|NCT01917461|"~     This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to~     enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at~     identifying individual biomarkers and constructing a multi-parametric diagnostic model,~     whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh~     cohort of patients.~      A collection of clinical, radiological and laboratory data will be gathered in order to~     establish a final diagnosis. Blood samples will be analyzed and the levels of approximately~     700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements~     respectively.~      A final diagnosis will be determined based on a majority decision of a panel of three or~     more independent physicians. Based on the final diagnosis, the accuracy of individual~     biomarkers and combined sets of biomarkers for differentiating between distinct groups of~     patients will be evaluated.~   "
87091|NCT01917448|"~     One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain.~     Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour~     postoperative requirement comparing to control group.~   "
87092|NCT01917435|"~     The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and~     the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth~     opening patients.~   "
87093|NCT01917422|"~     Dengue virus serological reagent, included antigen and antiserum, is a serum test for~     identification of serum antibodies to dengue virus.~   "
87094|NCT01917409|"~     The purpose of this study is to compare conventional laryngoscopy with video-stylet~     (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.~   "
87098|NCT01917357|"~     This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject~     is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials,~     with respect to protection against all antibodies (anti-hepatitis B surface antibodies,~     anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella~     pertussis) one (1) month after completion of the 6-10-14 week vaccination course.~   "
87099|NCT01917344|"~     Newborn screening and early treatment prevent the most severe manifestations of~     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,~     slow processing speed, and visual-motor problems commonly occur. Many adults with this~     disorder also suffer depression and anxiety. Using advanced electroencephalogram (EEG) and~     magnetic resonance imaging (MRI) techniques, including novel MR spectroscopy (MRS) we hope~     to discover why this distinct constellation of deficits occurs in PKU. Adult subjects with~     PKU will undergo EEG and comprehensive MRI evaluations, including a novel method of MR~     spectroscopy to determine brain phenylalanine levels. In addition, they will receive~     neurological and neuropsychological examinations and dietary evaluation.~   "
87100|NCT01917331|"~     Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to~     demonstrate the superiority of the triple fixed combination of~     Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the~     equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52~     weeks of treatment~   "
87101|NCT01917318|"~     The purpose of the study is to determine whether Iloperidone is effective in the treatment~     of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep,~     trauma dreams and daytime irritability or outbursts.~   "
87102|NCT01917305|"~     The concept of platform-switching has been introduced to implant dentistry based on clinical~     observations of reduced periimplant crestal bone loss. However, published available data are~     controversial and most studies are limited to 12 months. The aim of the present RCT was to~     test the hypothesis that platform-switching has a positive impact on crestal bone level~     changes after 3 years.~   "
87103|NCT01917292|"~     The purpose of this study is to determine the effect of periodontal intervention on vascular~     dysfunction among Chinese prehypertensive adults with moderate to severe periodontal~     disease.~   "
87104|NCT01917279|"~     It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with~     Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line~     Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast~     cancer(mBC).~   "
87105|NCT01917266|"~     The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in~     subjects with concordant versus discordant left ventricular (LV) lead position as compared~     to the site of latest mechanical activation.~   "
87106|NCT01917253|"~     The Long and Short is a prospective, randomized, controlled, open label trial to test the~     complications of different device for peripheral vein cannulation, standard length (about 5~     cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.~   "
87107|NCT01917240|"~     To evaluate the impact of two FDA approved culture media on potential of human embryos~     resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be~     randomly assigned to grow in monophasic media & the other half in sequential media. All~     embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from~     each group will be transferred resulting in a double embryo transfer (DET). If there are~     only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or~     frozen).~   "
87108|NCT01917227|"~     Objective:Health videos and group education to allow patients to a correct understanding of~     diabetes and insulin treatment.~      Method:~      Standards and number of patients: The patients received subcutaneous insulin injection,~     estimated 30 people enrolled.~      Experimental Design and Methods:~        1. Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial~          glucose (PPG)~        2. At the time of the visits, invite the patient to participate in the Video group~          education on insulin therapy By answering some questions about insulin injections, such~          as: do not know how to perform; afraid of the pain; fear of inconvenience, give~          patients time to complete the questionnaire.~   "
87109|NCT01917214|"~     This is a retrospective, non-interventional study which looks at the cohort of Renal Cell~     Carcinoma patients in a real life clinical setting and analyses into factors why these~     patients have been surviving for as long as 3-5 years unlike Clinical study where the~     survival is around 2 years.~      The factors which will be analysed include patient characteristics, dosage and adverse event~     management and tries to correlate these factors with survival.~   "
87110|NCT01917201|"~     The objective of this research is to assess the clinical results of implantation of~     different drug eluting stents under aggressive intravascular ultrasound (IVUS) guided all~     the way up to 24 months after operation and to establish the significance of the data of an~     optical coherent tomography (OCT) for the assessment of direct results of stenting and the~     degrees of endothelization of stent after 6 months.~      The following hypothesis formed the base for this study:~        -  IVUS guided intervention allows to improve the results and increase the safety of~          implantation drug eluting stents.~        -  Suboptimal results according to IVUS data can influence the follow up results of~          treatment.~        -  Suboptimal results according to OCT data, which are not revealed by IVUS, can influence~          the follow up results of treatment.~        -  The use of strategy of stenting with the achievement of optimal results under the~          intravascular methods of visualization allows to reduce the time of application of~          antiplatelet therapy.~        -  The modern limus-eluting stents do not differ in the follow up results in investigated~          criteria.~   "
87111|NCT01917188|"~     The initial aim of this study will be to assess current methods of heart failure (HF)~     patient education in terms of patient satisfaction, level of preparedness for home, and care~     provider satisfaction. The second aim will be to design and create a living with HF at~     home simulation session. The third aim will test the hypothesis that hospitalized HF~     patients who receive education in a simulation room in addition to usual HF education will~     have improved qualitative and quantitative outcomes as compared to those who do not receive~     the additional education support.~   "
87114|NCT01917149|"~     Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is~     the most common indication for heart transplantation worldwide. Despite advances in medical~     and device therapy, the 5-year mortality of patients with DCM remains high.~      Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and~     left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study~     of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril~     or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and~     standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause~     death or admission for heart failure. Additional prespecified outcomes included all-cause~     death, cardiovascular death, all-cause admission, heart failure admission. Secondary~     cardiovascular outcomes included the changes from baseline to the last available observation~     after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral~     regurgitation and wall-motion score index assessed by ECG. Adverse events were reported~     during in-hospital observation and follow-ups.~   "
87115|NCT01917136|"~     This study is looking at differences in metabolism and functional imaging between pulmonary~     hypertension subjects with normal right ventricular function and persistent right~     ventricular dysfunction. We will also measure right ventricular metabolic and structural~     changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment~     with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for~     normal function patients). This is a companion imaging trial for patients who are eligible~     for the treatment trial entitled A randomized, double-blind, placebo controlled,~     multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary~     hypertension and right ventricular dysfunction accompanied by a comparative study of~     cellular metabolism in subjects with pulmonary hypertension with and without right~     ventricular dysfunction. Subjects must enroll in companion treatment protocol to qualify~     for the imaging protocol.~   "
87116|NCT01917123|"~     In this randomized clinical trial before and after study we will assess the effect of~     L-citrulline malate on brachial index in patients with coronary heart disease based on their~     smoking history. Twenty patients with coronary heart disease with no history of diabetes or~     other chronic diseases and with no history of myocardial infarction in the last 6 months~     will participate in our trial.A written well-versed permission was attained from all~     patients. We will measure the brachial index tow times once before giving L-Citrulline~     malate and the other time after 2 weeks giving it.Patients receiving L-Citrulline malate as~     a 1 gram dry powder agent twice a day, that should in use with 250 mg dilute water .The~     patients will followed after 2 weeks by measuring brachial index which is our primary~     outcome measurement in this trial.We assumed that the brachial index in both smoker and~     non-smoker group of patients with coronary heart disease would change to normal or close to~     normal after giving 1 gram L-citrulline malate twice a day for 2 weeks.~   "
87117|NCT01917110|"~     The purpose of the study is to quantify the effectiveness of CooperVision MiSight®~     (omafilcon A) soft (hydrophilic) contact lens in slowing the rate of progression of~     juvenile-onset myopia.~   "
87118|NCT01917097|"~     This is a retrospective chart review to evaluate the postoperative course of all pediatric~     patients admitted to the hospital following adenotonsillectomy over the past 24 months to~     evaluate the incidence of bradycardia in children who received dexmedetomidine~     intraoperatively and identify confounding factors which may be precipitating the bradycardia~     or potentiating the negative chronotropic effects of dexmedetomidine.~   "
87119|NCT01917084|"~     To determine if an exercise program of passive range of motion (ROM) is safe and feasible in~     infants with single ventricle (SV) physiology after their Norwood procedure.~   "
87120|NCT01917071|"~     Hypothesis: There is no difference in directional specific manipulation of the thoracic~     spine for patients with neck pain.~      Patients seeking physical therapy for neck pain routinely have their thoracic spine~     manipulated. This study seeks to determine if directional limitations in the spine can be~     specifically determined and treated to decrease neck pain.~   "
87121|NCT01917058|"~     The purpose of this study is to determine if receiving sub-cutaneous injections of a~     medication called abatacept causes regrowth of hair in people with alopecia areata.~      Among patients with alopecia areata, patients with worse disease are unlikely to have~     satisfactory outcomes with current therapies. Our hypothesis is that Abatacept will be~     effective therapy in moderate to severe alopecia areata by blocking re-activation of a~     special type of immunecell call a memory T-Cell (CD8+NKG2D+)thereby blocking the~     inflammatory response underlying alopecia areata.~   "
87122|NCT01917045|"~     The investigators noticed that Body Fat Ratio might have great influence on the efficacy of~     different lipid soluble anesthetics. The objective of this clinical trial was to compare the~     effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.~   "
87123|NCT01917032|"~     Objective: To acquire the local scientific evidence, to evaluate the effects of~     micronutrient Sprinkles™ powder, both the nutritional status and haematological values in~     the vulnerable preschool population, to corroborate the reported benefits of the experiences~     in other countries.~      Question: Will it improve the nutritional status and hematological levels after the home~     fortification with Sprinkles in children of two child care centres in the city of Medellin,~     in 2013?~      Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators~     will be better in the intervention group with Sprinkles, compared with the placebo group.~      Design: Randomized clinical trial, triple-blind and placebo-controlled.~      Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or~     with severe malnourished, full-time assistants to two children's centres that have the same~     alimentation menu.~      Intervention: The daily diet will be supplemented with sprinkles in one of the children's~     centres and will be compared anthropometric and hematological values before and after with a~     group receiving the same diet with placebo.~      Outcome measures: Nutritional status (anthropometric measures) and haematological values~     (hemoglobin, ferritin, transferrin and folate).~   "
87305|NCT01914640|"~     The waist circumference (WC) cut off levels of the Caucasian people may not represent the~     characteristics of different ethnic groups. The investigators aimed to determine sex~     specific WC cut off points to predict obesity, metabolic syndrome and increased~     cardiovascular risk in Turkish adults.~   "
87124|NCT01917019|"~     This is a multicenter study conducted in 3 parts. Part A is a double-blind~     placebo-controlled parallel-group period, and Part B and C are open-label extension periods.~     The primary objective of the double-blind study (Part A) is to assess the effect of~     Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25~     foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the~     double-blind portion of the study is to evaluate the safety and tolerability of~     prolonged-release Fampridine in this study population. The primary objective of the~     open-label extension study (Part B) is to evaluate the long-term safety profile of~     prolonged-release Fampridine. The primary objective of the additional open-label extension~     (Part C) is to provide participants who complete the study with continued access to~     prolonged-release fampridine until marketed drug can be used at the applicable site or until~     sponsor decision to discontinue the study.~   "
87125|NCT01917006|"~     This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of~     premature ejaculation in male patients.~   "
87126|NCT01916993|"~     The purpose of this research study is to: test the safety, tolerability, and~     pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down~     and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in~     subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.~   "
87127|NCT01916980|"~     This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese~     participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this~     study is that the sum of the daytime and nighttime pruritus/itch scores for both the~     eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week~     2 compared to Baseline.~   "
87128|NCT01916967|"~     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese~     participants with chronic urticaria. The primary hypothesis is that the efficacy of~     desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in~     the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.~   "
87129|NCT01916954|"~     Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in~     sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can~     significantly reduce malaria-related morbidity and mortality in the mother and baby.~     However, therapeutic choices are limited by concerns about possible toxicity to the fetus~     and because of these concerns pregnant women are normally excluded from clinical trials.~     This, combined with the lack of adverse events reporting system, results in a scarcity of~     data on drug safety and efficacy in pregnancy. Moreover, changes in the maternal physiology~     in pregnancy often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a~     highly efficacious artemisinin-based combination therapy approved by the World Health~     Organisation for use in the 2nd and 3rd trimesters, although it is still infrequently used~     in pregnancy and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN~     are altered in pregnancy, resulting in reduced plasma concentrations and while the standard~     adult dose is still effective in high transmission settings, where pregnant women have~     higher levels of immunity, efficacy is reduced significantly in low transmission settings~     where women have lower levels of immunity. Inadequate antimalarial treatment dosing in~     pregnancy risks treatment failure or breakthrough infection and exposure of malaria~     parasites to sub-therapeutic drug concentrations thus selecting for drug resistance.~   "
87130|NCT01916941|"~     The study uses neurobiological measures through brain imaging, neuropsychological measures,~     and selfreport measures to try to understand how an effective treatment for alcoholism~     works. On the whole, less than 50% of people with alcoholism get better with treatment. This~     study will help researchers develop better treatments for alcoholism because if the~     investigators know why the treatments the investigators use are working, and in whom the~     treatments work best, then the investigators may be able to make treatment more effective by~     targeting treatments to individuals who would be most likely to benefit and by guiding~     development of more effective treatments in the future.~   "
87131|NCT01916928|"~     Women presenting to Washington Hospital Center with fetal loss would be offered~     participation in the study. The objective is to determine if ccffDNA obtained from maternal~     blood is present in the setting of missed abortion or fetal demise.~      The investigators primary hypothesis is that cell free fetal DNA will be present in maternal~     blood in the presence of a failed pregnancy.~   "
87132|NCT01916915|"~     Patients experience considerable amount of pain after cesarean section. The aim of this~     study is to investigate the effect of tramadol (an opioid pain killer) added to~     levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing~     a catheter in the incision) after cesarean sections.~   "
87133|NCT01916902|"~     Subjects presenting with probable acute coronary syndromes scheduled for cardiac~     catheterization will be enrolled in this study. Consented subjects will be randomized to~     receive ticagrelor started with a loading dose immediately after enrollment versus receiving~     a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but~     prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and~     the volume of thrombus within the new stent will be measured and compared between the~     groups.~   "
87146|NCT01916733|"~     The aim of this study is to examine the effect of moderate glucose (blood sugar) control in~     diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal~     aortic aneurysm (AAA) repair. We hypothesize that use of Fletcher Allen Health Care's~     current insulin infusion strategy will result in improved blood sugar control which will~     translate into decreased postoperative morbidity (fewer complications) and better long term~     outcomes when compared to patient outcomes at other institutions which utilize other blood~     sugar management strategies.~   "
87147|NCT01916720|"~     The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques~     after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives~     include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and~     plaque, specified biomarkers in blood and plaque and their respective correlation's with~     Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of~     SB-480848, and safety and tolerability in this population.~   "
91814|NCT01855425|"~     The study objective is to compare the CBCT images generated by the CS 9300 to those~     generated by conventional CT. It proposes a direct comparison of diagnostic image quality~     between the CS 9300 and conventional CT using double image examinations.~   "
87134|NCT01916889|"~     Delirium is a serious medical condition associated with increased mortality, longer hospital~     stay, increased rates of institutionalisation, and declines in post-admission functionality.~     Despite the prognostic utility of diagnosing delirium and its utility as an important~     indicator of health quality in elderly patients in developed countries, it is not routinely~     screened for in many busy general medical in-patient settings, especially in developing~     countries. Unpublished data from a recent study of general medical in-patients in Groote~     Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week~     period received any formal cognitive testing or had documentation of the presence/absence of~     delirium in routine clinical notes. This under-recognition is largely the result of the~     length and complexity of available delirium diagnostic tools e.g. Mini-mental state exam~     (MMSE), although the perceived lack of clinical importance and conflicting results about~     specific treatment modalities also contribute.~      The investigators recently developed the simple 4-question RACY delirium screening tool~     for use in general medical in-patients. Preliminary data show the test to be simple and~     effective with a sensitivity and specificity of 78% and 85% respectively using a~     ROC-selected cut-point of RACY≤2. The investigators hypothesis that the RACY screening tool~     has the potential to be a simple and effective bedside delirium diagnostic instrument for~     use in non-geriatric, busy general medical in-patient settings. This study is a two-centre~     validation study to evaluate the diagnostic accuracy of this tool.~   "
87135|NCT01916876|"~     The post discharge time is a vulnerable time for general medical in-patients, with high~     rates of adverse events that may cause unnecessary readmissions and even death. A recent~     study of 415 patients discharged from the general medical wards at Groote Schuur Hospital,~     demonstrated a very high 12 month mortality of 35%. The majority of these deaths were~     classified as unexpected. The reasons for this were not further examined, but it was~     speculated, given the authors' knowledge of the public sector in Cape Town, that three~     related factors contribute significantly to this early mortality: i) a lack of continuity of~     care, with patients not necessarily accessing the primary care support treatment that they~     need or being able to access early post discharge follow-up (for example for anti-retroviral~     or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature~     of the discharged patients, most whom have significant co-morbid disease; iii) A lack of~     optimisation of therapy for chronic disease after acute discharge.~      The investigators hypothesise that an integrated post-discharge transitional care package,~     which includes an early medical specialist follow-up in the first 3 months after hospital~     discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general~     medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated~     package, suitable to implementation if effective, with current standard discharge packages.~   "
87136|NCT01916863|"~     The purpose of this study is to assess the effect of LX4211 and the comparator drug~     canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy~     subjects in comparison to placebo.~   "
87137|NCT01916850|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive~     days) in healthy subjects.~   "
87138|NCT01916837|"~     In this prospective study the investigators sought to evaluate the feasibility of using the~     genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact~     on treatment recommendations.~   "
87139|NCT01916824|"~     During episodes of depression patients with MDD may make sub-optimal decisions based on~     exaggerated negative beliefs about themselves, the future, or the world around them. These~     disruptions in decision-making contribute adversely to quality of life, in both work and~     personal realms. Although effective treatments for depression are available, very little~     work has explored the effects of treatment on how people make decisions. The specific~     aspects of decision-making that differ between depressed and health control individuals are~     unknown, and whether any changes in these decision-making features occur as a result of~     improvement from depression, or whether medication treatment itself can lead to changes in~     decision-making, even in the absence of clinical improvement.~      In this trial, fifty participants with current major depressive disorder who are not~     receiving an antidepressant medication and fifty healthy controls will complete~     questionnaires and computerized tasks to assess their decision-making styles. There will be~     three visits for depressed patients and two for healthy controls (the first and third~     visits). The first visit will involve interviews and questionnaires to assess the~     participant's level of depression, medical history and quality of life. Participants will~     then complete the decision-making tasks, and will earn between $5-40 based on their choices,~     in order to make the decisions on the computer tasks financially meaningful. At the~     completion of this visit, depressed patients will be prescribed an FDA-approved~     antidepressant, chosen in consultation with the treating psychiatrist. Patients will be~     responsible for paying for the prescription themselves. After two weeks on the medication,~     the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After~     six weeks on the medicine, patients and healthy controls will return to repeat the~     questionnaires and the computer based decision-making tasks, and will again earn between~     $5-40 based on their performance.~      The overall goal of this study will be to identify whether decision-making characteristics~     in people with major depression is affected by treatment, and whether depressed patients~     make decisions differently from healthy controls. A total of 4 decision-making tasks and one~     control task will be administered via computer to eligible subjects.~   "
87140|NCT01916811|"~     The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar~     small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered~     with low back pain.~   "
87141|NCT01916798|"~     Intralipid can suppress natural killer cells that are known to be involve in repeated~     implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil,~     egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid,~     omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in~     suppressing natural killer cell activity (NKa) were found to be comparable to intravenous~     immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid~     infusion on the pregnancy outcome of women aged 35-40 years with history of repeated~     implantation failure of miscarriage and who have positive peripheral blood natural killer~     cells~   "
87142|NCT01916785|"~     This protocol is a multicentric interventional phase II study from the French CML Intergroup~     (FILMC).~      The core of the protocol is to explore the efficacy and safety of an optimization strategy~     consisting in the modulation of the dasatinib daily dose according to the results of~     repeated plasmatic levels of dasatinib.~      The objective of this strategy is to improve the overall results of the treatment of early~     CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase~     mutations.~      The study will be conducted in selected FILMC and Canadian centers.~      The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb.~     The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing~     authorization is granted in that indication.~   "
87143|NCT01916772|"~     To observe the natural history of cherubism.~   "
87148|NCT01916707|"~     Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To~     minimize the risk of these blood clots developing, patients may be given a blood-thinner~     drug such as enoxaparin.~      Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her~     weight. However, a recent study suggests that for obese patients, the set dose may be~     inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin~     that is based on the patient's weight will help to prevent the formation of blood clots.~      The information gathered through this study will help doctors to understand the best way to~     prevent blood clots in future trauma patients. The potential risks of participating in this~     study include the minor risks of blood draws and ultrasounds, as well as the more~     significant risks of bleeding as a side effect of the enoxaparin.~   "
87149|NCT01916694|"~     Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to~     problems for both mothers-to-be and their babies such as causing a large baby and difficult~     birth. Gestational diabetes in the mother may also lead to effects on the long term health~     of the baby.~      Most people today use mobile phones. Our research is looking at using a mobile phone app to~     help with diabetes care in pregnancy. In particular, the investigators are using phones~     which connect to the standard blood glucose monitoring machines given to all women with~     gestational diabetes to see if sending the hospital team blood test results between clinic~     appointments can result in the need for fewer clinic visits. The investigators are also~     testing to see how acceptable using mobile phones in this way, is to our patients and that~     the control of the blood glucose and outcomes for the mother and baby are at least as good~     as standard care.~      The investigators are planning to recruit 200 women who receive care for their gestational~     diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will~     be randomised so that 100 will receive standard care, and 100 will have a mobile phone app~     linked to the blood glucose machines to send blood glucose readings directly to the diabetes~     care team to review.~      Both groups will be asked to test their blood glucose levels at home regularly with a~     glucometer. All participants will also be given lifestyle advice to reduce the chance they~     will need medication. Blood glucose control will be measured also by the percentage of~     glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before~     delivery.~   "
87150|NCT01916681|"~     The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and~     continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase~     (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time~     periods to define a failed IOL, there are no guidelines or accepted definitions of when to~     call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged.~     While decreasing the CD rate is an important primary focus in obstetrics, attention must~     also be paid to the overall length of labor given that prolonged labor is associated with~     adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an~     increase in direct hospital costs and healthcare utilization. The use of cervical ripening~     agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to~     reduce labor time and CD rate. In addition to specific individual agents, certain dosing and~     regimens for IOL and active labor have been compared to evaluate whether a particular dose~     or regimen can decrease the length of labor and decrease the CD rate. Most of these~     regimens; however, focus on individual induction agents and few have compared the efficacy~     of using more than one agent simultaneously. Given the associated risks of prolonged labor~     and limited data evaluating the use of combined cervical ripening agents, our objective is~     to evaluate the difference in time to delivery among women who undergo an IOL with four~     different methods.~   "
87151|NCT01916668|"~     Observational evidence indicates that intradialytic hypertension is associated with high~     morbidity & mortality. The investigators impression is that this problem may be more~     prevalent than initially suspected. To the investigators knowledge, there are no studies on~     intradialytic hypertension in the South African haemodialysis population.~   "
87152|NCT01916655|"~     OSA is a major chronic condition affecting the quality of life of millions of Americans. Per~     the Institute of Medicine new treatment adherence strategies are needed to help improve the~     quality of care, reduce social and economic costs, and help those with chronic conditions~     (such as OSA) live healthier and more productive lives through better management of their~     conditions. Using an mHealth tool to help deliver the investigators' Self-Management~     intervention and improve the frequency and quality of patient-provider communications is a~     central component of that discovery process.~   "
87153|NCT01916642|"~     IV lidocaine administration can reduce the minimal amount of Etomidate and time for~     induction of anesthesia.~   "
87154|NCT01916629|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of psoriasis~   "
87155|NCT01916616|"~     Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords~     while inhaling. Children and adolescents with VCD may experience multiple symptoms,~     including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There~     is limited information on optimal management of VCD. In our proposed study, we will use~     cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD~     symptoms. Measurements of airflow during breathing as well as symptom frequency and~     intensity will be examined prior to and following a series of four therapy sessions with a~     clinical psychologist that are focused on teaching patients strategies to decrease symptom~     reactivity.~   "
87167|NCT01916447|"~     The purpose of this study is to investigate the safety and determine the maximum tolerated~     dose of TAS-102 administered in combination with CPT-11 in patients with advanced~     gastrointestinal tumors.~   "
87306|NCT01914627|"~     The study will be conducted to evaluate the efficacy and safety of a topical dimeticone~     formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15%~     Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis~     (scalp psoriasis).~   "
91815|NCT01855412|"~     The purpose of this study is to evaluate acute and long term clinical and economic outcomes~     of endovascular procedures to treat Peripheral Arterial Disease (PAD).~   "
87156|NCT01916603|"~     NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs~     origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies~     show that maternal BMI before conception and during pregnancy predict future risk of obesity~     and associated metabolic conditions in both mother and offspring. Weight gain during the~     first two years of life is also critical in defining the infant's predisposition to obesity~     during adulthood. Objective: to assess the effectiveness of delivering a primary health care~     intervention to enhance compliance with updated nutrition and health care (diet, physical~     activity and breastfeeding) standards from early pregnancy through the first year of life.~     Methods: cluster randomized controlled trial (CRCT), designed as a public health~     intervention program effectiveness study (i.e. intervention will be available through the~     established national health system under standard operating conditions). A cluster unit will~     be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly~     allocated to: enhanced nutrition and health care (intervention group) or routine nutrition~     and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20%~     loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the~     intervention PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet~     and physical activity (PA) counseling-support based on updated recommendations and~     monitoring goals for weight gain & glycemic control and breastfeeding (BF) promotion till 12~     m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care~     according to national guidelines. Expected results: participants in the intervention PHCCs~     will benefit by achieving adequate nutritional status & metabolic control, during and early~     after, pregnancy as well as adequate infant growth & development as a result of improved~     nutrition and health care practices. The results will likely be generalizable through the~     primary health care system; considering this is a program effectiveness trial conducted~     under real life conditions . Additionally, we will include specific ancillary mechanistic~     projects to better characterize the intervention and its impact.~   "
87157|NCT01916590|"~     Both single shot femoral nerve block and continuous femoral nerve block with catheter have~     been shown to be effective for pain control after anterior cruciate ligament reconstruction~     (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain~     scores and opioid consumption for the first 48 hours postoperatively.~   "
87158|NCT01916577|"~     The purpose of this study is to determine if the drug Plerixafor (Mozobil) can lead to~     clinically relevant efflux of CD117+ stem cells from the bone marrow to the peripheral blood~     of normal controls and patients awaiting lung transplantation. The investigator's hypothesis~     is that Plerixafor (Mozobil) will lead to significant mobilization of CD117+ stem cells to~     the peripheral blood.~   "
87159|NCT01916564|"~     This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus~     bisacodyl for bowel preparation for morning outpatient colonoscopy.~   "
87160|NCT01916538|"~     The Anorexia Nervosa Genetics Initiative (ANGI) is the largest and most rigorous genetic~     investigation of eating disorders ever conducted. Researchers in the United States, Sweden,~     Australia, and Denmark will collect clinical information and blood samples from over 13,000~     individuals with anorexia nervosa and individuals without an eating disorder.~      ANGI represents a global effort to detect genetic variation that contributes to this~     potentially life-threatening illness. The goal of the research study is to transform~     knowledge about the causes of eating disorders to work toward greater understanding and~     ultimately a cure.~      If you have suffered from anorexia nervosa at any point in your life, you can help us~     achieve this goal. Your contribution would include a brief questionnaire and a blood sample.~     If you have never had anorexia nervosa, but still want to contribute, we invite your~     participation as well.~   "
87161|NCT01916525|"~     The objective of this multidisciplinary study is to employ health-economic evaluation in~     determining the health benefits achieved with exercise-based cardiac rehabilitation and the~     costs derived from it compared with conventional post-acute care of cardiac patients in the~     Finnish health care system.~   "
87162|NCT01916512|"~     The aim of this study is to determine whether high high density~     lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP)~     activity is atherogenic or not in subjects who received health checkups. We investigate the~     association between CETP activities and the severity of atherosclerosis assessed by~     intima-media thickness (IMT) and compare the atherogenic change between in subjects with~     high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining~     the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG)~     change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and~     various serum atherogenic markers. And we also examine the correlation between normal lipid~     profile and concentration, activity and function of surface lipoprotein in subjects with~     variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia,~     hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant~     cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.~   "
87163|NCT01916499|"~     This study involves adolescents operated with arterial switch procedure for transposition of~     the great arteries during the neonatal period. The purpose is to evaluate the coronary~     arteries and direct and indirect findings of coronary artery disease/complications with 3~     tesla magnetic resonance imaging.~   "
87164|NCT01916486|"~     The investigators will conduct a proof-of-concept randomized controlled trial study to~     provide preliminary evidence of efficacy of exercise training or a complex mental and social~     activities program for improving cognitive function in older adults with chronic stroke,~     compared with a stretch and relaxation program.~   "
87165|NCT01916473|"~     Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between~     the epidural and continuous wound infusion techniques.~   "
87166|NCT01916460|"~     Patients who empty their stomach slowly may have what we call Slow gastric emptying or~     gastroparesis. These patients can have some changes in the thickness of their stomach~     wall. In addition, they may have loss of some important nerve cells in their stomach~     muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample~     from the stomach wall to examine the loss of these cells can help in diagnosing~     gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was~     to undergo an operation in the surgery suite and be hospitalized for several days after the~     procedure. Usually, we obtain this sample while these patients are having a surgery for~     another purpose such as placement of a gastric stimulator (a machine which is inserted in~     the stomach wall to control the stomach rhythm and thus help the stomach to empty faster).~     Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound~     installed in the tip of the tube) that can measure how thick the stomach wall is and can~     provide sample biopsies of the stomach wall which can be studied for the loss of these~     specialized muscles and cells.~      We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to~     diagnose gastroparesis and can replace the need for obtaining samples by surgery.~     Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.~   "
87168|NCT01916434|"~     Consumption of fish can help to prevent cardiovascular disease. The precise way in which~     fish is beneficial is not fully understood. This is important to find out as fish consists~     of a complex mixture of fatty acids and micronutrients such as vitamin D and selenium that~     could individually, or collectively, be responsible for the beneficial effects.~      Fish farming in Scotland is playing an increasingly important role in the provision of fish~     for human consumption. But issues with sustainability of raw materials are requiring fish~     farming to reformulate fish diets, which may affect the levels of beneficial omega-3 fatty~     acids and other components in fish.~      In this study we will be comparing the long-term health effects of eating two portions a~     week of Scottish salmon raised on a traditional fish diet versus eating two portions a week~     of Scottish salmon raised on a more sustainable fish diet. In addition, we will be looking~     at differences in health outcomes when eating two portions a week of either Scottish salmon,~     compared with eating no fish at all.~   "
87169|NCT01916421|"~     Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a~     flexible tube with a camera and small ultrasound machine at its end )requires the use of a~     needle for taking the sample from the lesion or what we call Fine needle aspiration (FNA).~     Currently, FNA is done by three commercially available needles. These needles are used~     routinely in our institution for FNA. The data regarding the safety and the successfulness~     of any of these needles are lacking. We sought to compare all three commercially available~     needles in a prospective manner.~   "
87170|NCT01916408|"~     The aim of the present study is to investigate changes in inflammatory status and incidence~     of infection after extreme aerobic physical stress (participation in a marathon). In~     addition, the impact of marathon running on the hemostasis and muscular state will be~     evaluated. Changes at the inflammatory, muscular, and rheological level will be related to~     ingestion of oral hydrolytic enzymes and bioflavonoids.~   "
87171|NCT01916395|"~     The primary objective is to determine whether inflammatory markers, such as C-Reactive~     Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide~     (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated~     with Imitrex or Treximet.~      The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive~     Protein (CRP) in patients with active migraine headaches.~   "
87172|NCT01916382|"~     This is a proposal to develop the orphan designated drug, nitisinone, for the treatment of a~     rare Mendelian disease, Alkaptonuria (AKU). Thanks to our existing successful fundamental~     and clinical research (cell models, animal models, natural history studies), we are now~     ready for this final stage of clinical development of nitisinone for AKU: a phase 3 clinical~     trial to prove efficacy. The results of DevelopAKUre will allow us to make the case to the~     European Medicines Agency for marketing authorisation of nitisinone for AKU, thereby~     contributing to the goal of the International Rare Diseases Research Consortium of~     developing 200 new therapies by 2020.~   "
87173|NCT01916369|"~     The primary objective of the Phase I ascending dose trial is to investigate the safety and~     tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product,~     CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial~     is based on independent preclinical data from a leading academic research institution that~     has been submitted for publication. Inclusion of patients with Fontaine Stage II is~     justified as these patients have a lower incidence of background events and will facilitate~     distinction between events which are possibly intervention-related versus spontaneous events~     associated with underlying advanced atherosclerosis. The trial is designed to treat 9-18~     patients and evaluate safety measures over a 12 month follow-up period.~   "
87174|NCT01916356|"~     The purpose of this study is to determine the effectiveness of an online informational video~     in improving knowledge about infertility in couples experiencing problems conceiving. A~     pilot study will be conducted with first and second year medical students.~   "
87175|NCT01916343|"~     Gynecologists are currently using laparoscopy to perform many surgeries traditionally~     approached by laparotomy. The technical skills required for laparoscopic surgery are~     different than the skills required for laparotomy, causing a prolonged learning curve.~     Currently there is no standardized laparoscopy curriculum for gynecology residents. This~     study aims to develop a specific evidence-based surgical skills gynecologic curriculum that~     could be instituted in residency programs at a national and international level. The~     investigators will then validate the curriculum using Obstetrics and Gynecology residents~     through a cognitive examination, a technical skills examination, and a video recording of~     performance in the operating room.~      HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive~     laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team~     training exercises. The investigators hypothesize that residents in the experimental~     curriculum-trained group will perform better than the residents in the traditional residency~     curriculum-trained group on a cognitive examination, a technical skills examination, and in~     the operating room. The operating room performance will be judged by blinded experts on a~     previously validated evaluation tool.~   "
87176|NCT01916330|"~     Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and~     fetus~   "
87177|NCT01916317|"~     Voltage Gated Sodium Channels Over the years, there is more evidence that ionic channels are~     involved in the oncogenic process. Among these, voltage gated sodium channels (VGSC)~     expressed in non-nervous or non-muscular organs are often associated with the metastatic~     behavior of different cancers.~      Expression of VGSCs has been reported both in vitro and/or in vivo in a range of human~     carcinomas, including breast cancer Ion channels are major signaling molecules expressed in~     a wide variety of tissues. They are involved in determining a variety of cellular functions~     like proliferation, solute transport, volume control, enzyme activity, secretion, invasion,~     gene-expression, excitation-contraction coupling, and intercellular communication.4 VGSC~     activity contributes to much cellular behavior integral to metastasis, including cellular~     process extension, lateral motility and galvanotaxis, transverse invasion, and secretory~     membrane activity.~      A correlation between Na transport and oncogenesis has been widely reported in literature.~     In 1980, transformed mouse mammary cells were shown to have 3-fold higher intra-cellular~     sodium content than untransformed cells.5 Additionally evidence suggest that increasing the~     inward sodium current through voltage gated sodium channels increased the invasive capacity~     of breast cancer.6 Also, growth and proliferation of mammary adenocarcinoma cells can be~     inhibited by Amiloride suggesting that epithelial Na channels (ENaC) activity is correlated~     with proliferation of breast cancer cells~      Current evidence suggests that VGSC activity is necessary and sufficient for cancer cell~     invasiveness8. A recent in vitro study has shown that the human MDA MB 231 breast cancer~     cell line expressed functional VGSCs9. However, the molecular nature of the VGSC and its~     functional relevance to breast cancer in vivo are currently under study.~      Surgical operations for cancer have been reported to induce dissemination of cancer cells~     into surrounding tissues or into the circulation10,11and infiltration anesthetics can~     inhibit immune response12-14. Although the mechanism remains to be elucidated, infiltration~     anesthetics such as lidocaine have membrane- stabilizing action (Seeman, 1972) and these~     agents could have direct effects on cancer cells. Therefore, it is important to clarify the~     effects of infiltration anesthetics on behavior of the tumor cells.~      Commonly used local anesthetic agents inhibit the VGSCs and also possess a unique membrane~     stabilizing action through other unknown mechanisms. A study by Mammota et al 15 reported~     that lignocaine, effectively inhibited the invasive ability of human cancer (HT1080, HOS,~     and RPMI-7951) cells at concentrations used in surgical operations (5-20 mM). Lidocaine~     reduced the invasion ability of these cells by partly inhibiting the shedding of HB-EGF from~     the cell surface and modulation of intracellular Ca2+ concentration contributed to this~     action. In addition, lidocaine (5-30 mM) infiltrated around the inoculation site, inhibited~     pulmonary metastases of murine osteosarcoma (LM 8) cells in vivo.~      Dose of lidocaine15:~      40 mM (1%) lidocaine is usually used for infiltration anesthesia for surgical operations.~     Lower concentrations (1-20mM) of lidocaine were sufficient to suppress the invasive ability~     of cancer cells14. One mM lidocaine inhibited the invasive ability of HT1080 cells by about~     50%, and 20 mM lidocaine inhibited the invasion ability completely. Lidocaine also inhibited~     dose-dependently the invasive ability of HOS and RPMI-7951 cells, although it was less~     effective on HOS cells. Lignocaine exerts its anesthetic action by obstructing the sodium~     channel 16 however, 10 mMof tetrodotoxin (TTX), a specific sodium channel inhibitor, had~     little effect on the invasive ability of HT1080 cells. Ten mM lidocaine-N-ethylbromide~     (NEB), which does not cross the cell membrane, also had little effect on the invasive~     ability of the cells.~      Objectives~      Primary Objective:~      • To assess the in-vivo ability of local anesthetics agents like lignocaine to decrease the~     dissemination of cancer cells during surgery and improve the disease free interval~      Secondary Objective~      • To assess the in-vivo ability of local anesthetics agents like lignocaine on impacting~     long term survival.~      Methodology / Treatment plan~      The study drug (0.5% lidocaine 60mM) will be tested in the intraoperative setting prior to~     surgery will be tested in a randomized setting.:~      Arm A: 60mM of 0.5% lignocaine will be injected peritumoral prior to excision. The local~     anesthetic should be injected on all 6 surfaces of the tumor and also within the tumor. Wait~     for 7 minutes for its action followed by surgery. (Intervention arm) Arm B: No injection of~     lignocaine prior to excision (Control arm)~   "
87178|NCT01916304|"~     The purpose of this study is to investigate the effect of switching participants taking~     levothyroxine to a new sodium formulation.~   "
87179|NCT01916291|"~     Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has~     intact membrane after 38weeks of gestational age. The investigators study safety and~     efficacy of dinoprostone in the pregnant women with premature rupture of membrane or~     GA<38weeks~   "
87180|NCT01916278|"~     A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and~     efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.~   "
87181|NCT01916265|"~     The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and~     glucagon) substituting for the pancreas and facilitating tight euglycemic control in~     patients with T1DM.~   "
87381|NCT01913600|"~     Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety~     and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native~     coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients~     who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length~     Study.~   "
87182|NCT01916252|"~     This protocol is a national, multicenter, comparative, open-label, randomized trial~     comparing the progression free survival (PFS) of two pre-transplant conditioning regimens~     (BUMEL versus. MEL-200).~      A total of 460 patients will be enrolled in the study. Scheduled evaluations and study~     visits will take place during the pre-treatment, treatment and follow-up periods.~      The pre-treatment period includes the screening visit in which participants provide informed~     consent in writing in order to take part in the study. The patient is then assessed to~     determine his/her eligibility. The selection process will begin 21 days before the first~     dose of medication is administered (days -21 to 0). During the treatment period, eligible~     patients will be included in the study and given six cycles of induction treatment with~     bortezomib/ lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during~     which SC bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days~     1-21 of each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.~      After the first three induction cycles, and in the absence of progression or unacceptable~     toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using~     G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation~     ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take~     place at the beginning of the study, once the screening is complete and the patient's~     eligibility verified. Three months after transplantation, patients will receive two cycles~     of consolidation treatment with VRD-GEM at the same doses administered during induction~     treatment.~      Once the treatment phase is complete, patients will begin the follow-up phase in which they~     will be visited every three months to evaluate disease progression and survival~   "
87183|NCT01916239|"~     The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively~     metabolized by the human gut microbiota to yield a number of metabolites called urolithins~     (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes~     involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in~     the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer~     activities. After colonoscopy and diagnosis, colorectal cancer patients will consume~     capsules containing three different pomegranate extract formulations until surgery. The aims~     of this trial are:~        -  To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and~          normal colon tissues.~        -  To evaluate gene expression profiling and protein markers in tumoral and normal colon~          tissues from these patients.~        -  To compare different pomegranate extract formulations on the above.~   "
87184|NCT01916226|"~     This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week~     treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and~     ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS~     provides greater nasal symptom relief than cetirizine. The primary measure used to test this~     hypothesis is the change from baseline over two weeks in reflective total nasal symptom~     score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be~     randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to~     thirty-five sites in the US during the 2013 fall allergy season. All subjects will be~     outpatients. The total duration of study will be approximately 21 days including 7 days of~     screening period, and 14 days of treatment period.~   "
87185|NCT01916213|"~     The investigators would like to assess whether selecting mature sperm using PICSI (selecting~     for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .~      Aim~        1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection~          using PICSI plates in terms of implantation and fertilization rates for couples with~          male factor fertility~        2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage~          rates for couples with male factor infertility using routine sperm selection with ICSI~          compared to using PICSI plates for sperm selection~      Hypothesis:~      Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison~     to sperm selected for conventional ICSI~   "
87186|NCT01916200|"~     This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the~     efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive~     Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS).~      Subjects will be patients who are referred to the outpatient or inpatient clinic of~     gastroenterology departments of province level general hospitals in China. All subjects~     present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD~     by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written~     informed consent prior to participating in the study. Subjects will be assessed for~     eligibility at a screening visit, with eligible patients returning for a assessment within 1~     week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose:~     12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be~     evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study~     treatment visits.~   "
87187|NCT01916187|"~     The purpose of this study is to determine the best dose of imetelstat when given alone for~     patients with neuroblastoma and also when given in combination with 13-cis-retinoic acid.~   "
87188|NCT01916174|"~     This trial is conducted in Europe. The aim of this trial is to assess the expected~     biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira)~     with identical active ingredient in healthy volunteers.~   "
87189|NCT01916161|"~     Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a~     profound effect on the patients quality of life. Disease education is a corner stone of IBD~     care to enable patients to take up an active role in their disease management. While patient~     education is enshrined in the IBD standards, actual patient knowledge is often poor.3~     Knowledge is not associated with the level of the patient's educational achievement, but~     member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly~     better knowledge than non-members. This may highlight the positive effects of education~     offered by CCUK, but it is also conceivable that patients with a greater interest in their~     disease are more like to join organisations like CCUK. Different sources of patient~     information may therefore influence what level of disease related knowledge a patient~     achieves.~      Apart from high quality clinical information provided by professional organisation (British~     Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health~     Service and charities (CORE, CCUK), there is also a host of unregulated information~     available. The emerging dominance of the internet for information gathering has provided~     easy access for patients to a host of websites providing information on IBD. A number of~     these provide alternative (not evidence based) views, which could have a potentially~     negative impact on patient's knowledge. Furthermore patients often share their stories on~     internet forums and it is likely that those stories share are more likely to represent the~     extreme ends of disease rather than those experienced by the majority. This could~     potentially cause anxiety in patients with IBD. The quality of information found on the~     internet varies widely and up to 50% of websites have been judged as poor. The vast majority~     of patients with IBD have access to the internet and more than half use to search for health~     related information.7 We have previously also demonstrated that patients with anxiety have~     better disease related knowledge of IBD.~   "
87190|NCT01916148|"~     This purpose of this study is to determine the ability of an~     18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of~     hyperinsulinism and determine the location in patients with congenital hyperinsulinism,~     Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.~   "
87382|NCT01913587|"~     This study is to investigate the effectiveness of acupuncture for alleviating pain from~     Spinal Compression Fracture in Patients Treated with Nerve Block.~   "
87191|NCT01916135|"~     This study is the first time that a new experimental drug called [18F]-SKI-249380 is being~     used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that~     will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its~     injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find~     tumors in patients.~      This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is~     given to people in tiny amounts by an injection into a vein in their arm, and to see where~     [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study~     doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380~     are better for finding tumors compared to the standard types of scans that doctors use.~   "
87192|NCT01916122|"~     These are tumors which expresses estrogen receptors. Estrogen receptors are found within~     breast cancer cells and are an important marker of which medicines may best treat a breast~     cancer. This study is being performed to imaging the amount of estrogen receptors expressed~     in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors~     and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a~     machine that can take pictures of where the FES is and how much FES is present. The results~     of this study may help researchers know whether FES can be used to monitor changes in~     estrogen receptors in tumors during treatment.~   "
87193|NCT01916109|"~     The purpose of this study is to find out if using the combination of standard chemotherapy~     (gemcitabine and carboplatin) plus this new drug (panitumumab) can help to shrink the tumor~     before the patient undergoes surgery for bladder cancer.~   "
87194|NCT01916096|"~     The primary objective of the study examines the success rate of various OneTouch Delica~     lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is~     based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4~     times with two lancet sizes at a single depth setting. There will be 120 paired lancing~     events for each lancet size within the group.~      Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of~     1.0μL for the 28g lancet across all depth settings.~      Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for~     the 28g lancet across all depth settings is less than 90%.~   "
87195|NCT01916070|"~     Patients with the symptom complex syncope or near-syncope are quite often in the emergency~     department. Most patients with syncope have a positive prognosis. However some types of~     syncope are associated with an increased morbidity and mortality. It is a challenge to~     detect these patients reliably at an early stage. The current guidelines contain exact~     definitions concerning the characteristics of patients with syncope and recommendations on~     how to diagnose and treat these patients following standardized pathways. Due to the fact~     that near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data~     concerning near-syncope are rare.~      Our aim was to characterize patients presenting with syncope or near-syncope to the~     emergency department regarding their risk profile, comorbidities and prognosis. First we~     evaluated if there is a difference between the two groups syncope and near-syncope~     concerning type and frequency of adverse events. Furthermore we analyzed the routinely~     measured cardiac biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope.~     Then we determined both their prognostic accuracy in predicting adverse events and their~     diagnostic accuracy in finding the underlying etiology. Finally we analyzed a special~     patient collective, patients aged ≥ 65 years. It is assumed that elderly patients are~     suffering from comorbidities and age-related physiological and cognitive disabilities. We~     therefore hypothesize that elderly patients, in contrast to patients aged < 60, display an~     increased risk of adverse events and that they have a poorer prognosis.~   "
87196|NCT01916057|"~     The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG)~     positron-emission tomography scan (PET scan) is useful for the therapy strategy of~     hepatosplenic candidiasis.~   "
87197|NCT01916044|"~     The rate of caesarians dramatically increased for 15 years. The main indication of caesarian~     became the iterative caesarian of principle because of a history of caesarian. Any attempt~     of reduction of the rate of caesarians should thus focus on the indications of iterative~     principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of~     the attempts of low way after caesarian is the concern generated by the risk of uterine~     break during the trial of labor. Yet, there is no reliable method to predict this risk of~     uterine break. A way of interesting research consists in estimating the potential profits of~     the echography of the scar lower segment. Indeed, the echography can be useful to determine~     the specific risk of uterine break of a patient by measuring the thickness of the lower~     segment of the womb.~      The strong negative predictive value of the echography of the lower segment on the risk of~     uterine break should encourage the women encircled to accept a trial of labor. That is why,~     this examination associated with a rule of decision could help to decrease the rate of~     iterative elective caesarians and especially to decrease the mortality and the foetal and~     maternal morbidity connected to the trial of labor among the patients having a history of~     caesarian.~   "
87198|NCT01916031|"~     The purpose of this study is to comparatively assess the effectiveness of a tailored~     educational intervention to improve health literacy levels regarding upper respiratory~     infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino~     households in Early Head Start.~   "
87223|NCT01915706|"~     The purpose of this study is to compare the post-operative complication rates and surgical~     outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in~     clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater~     with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350~     implant will be recruited and randomized at the time of enrollment to either scheduled~     ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications~     will be documented and compared between the 2 groups. The final intraocular pressure control~     between the 2 groups will also be compared in a secondary outcome analysis. This study will~     help to establish post-operative management guidelines to minimize complications and improve~     intraocular pressure lowering success following Baerveldt 350 implantation.~   "
87383|NCT01913574|"~     This study is to investigate the effectiveness of acupuncture for alleviating the upper~     abdominal pain of cancer patients~   "
87199|NCT01916018|"~     Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This~     condition is detected consistently since the late 1970s in France, which has led to early~     care and a significant improvement in prognosis and intellectual stature of these children.~     However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases~     have been reported in approximately 10% of cases. These observations are in most cases~     poorly understood. The family nature of the CH is now well recognized and a dozen genes~     involved up to now. However, in the majority of cases (HC not due to a disorder of the~     organification of iodine), few mutations have been found in the reported number of patients~     (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated~     in particular specific syndromic forms but many pathological associations remain~     unexplained. Also, a more complete genetic elucidation of CH would enable a better~     understanding of its etiology and thus its risk of familial recurrence (frequently asked~     questions by parents of children with CH) and secondly the presence of associated~     pathologies.~      Main goal: to describe the population with CH (not due to a disorder of the organification~     of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also~     on the genetic level to establish a genotype / phenotype correlation.~   "
87200|NCT01916005|"~     The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases,~     initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a~     decreased diagnostic accuracy for the modified Duke criteria.~      Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron~     emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.~      Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou~     European Hospital, Paris), the investigators plan to include consecutive patients suspected~     of having PVE. All of the patients will be subjected to clinical, microbiological, and~     echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data~     analysis will be based on visual interpretation and quantitative measurement of FDG uptake~     (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological~     modified Duke criteria determined during a 3-month follow-up (gold standard).~   "
87201|NCT01915992|"~     The NK cells participate in the innate immunity against infectious agents or transformed~     cells that are recognized as no self by the absent, weak or abnormal expression of human~     leukocyte antigen (HLA) class I molecules. According to the missing self hypothesis, a~     negative signal is delivered to NK cells when their inhibitory receptors are engaged by the~     specific HLA class I molecules. NK activation requires a positive signal delivered by the~     engagement of activating receptors, more particularly of the Natural cytotoxicity~     receptors or NCRs who are directly involved in the natural cytotoxicity of Natural Killer.~     The activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3~     respectively. NKp46 and NKp30 are constitutively expressed on the surface of the NK, the~     expression of NKp44 is observed only after activation of cells NK. NK cells from most (80%)~     healthy donors express a high quantity of NCR on their surface, corresponding to the~     NCRbright phenotype while only 20 % present the NCRdull phenotype. In sharp contrast, most~     patients (80%) having leukaemia have the NCRdull while only 20 % patients have the NCRbright~     phenotype. The culture of NK from healthy donors ( NCRbright) with leukaemic cells result in~     decreased expression of the NKp30 while there is no difference on expression if these same~     NK are cultivated with cells from healthy donors. Moreover, study of AML patients showed~     that the NCRdull phenotype was acquired during leukemia development because it was observed~     its complete (for NKp46) or partial (for NKp30) reversibility in patients achieving complete~     remission (CR). Reversibility of the NCRdull phenotype after CR suggested that leukemia~     cells might be involved in NCR down-regulation. In line with these observations, we aim to~     study the mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors~     with leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of~     the NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If~     this hypothesis is be verified, we will study the regulation of NCR by focusing on the~     implication of genes NCR transcription factors via bio-informatic analysis of putative~     transcription factors fixation sequences in the promoters of these genes, followed by the~     verification of the capacity of identified sequences to bind transcription factors.~     Ultimately, we will verify the real implications of these transcription factors by studying~     the effect of their silencing by RNA interference experiments.~   "
87202|NCT01915979|"~     The overall objective of the study is to assess the effectiveness of the treatment of~     degenerative rotator cuff tendinopathy using the application of plasma rich in growth~     factors (PRGF).~      Main objective:~      To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the~     reference test of more than 15% compared to the treatment with corticosteroids.~      Secondary objective:~        -  To assess the efficacy of the treatment after 12 months.~        -  Quantification of platelet levels in patients treated with plasma rich in growth~          factors and its correlation with the clinical effect.~   "
87203|NCT01915966|"~     Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your~     mouth. It's a frequent symptom in terminally ill patients receiving palliative care,~     reducing their quality of life and comfort. Usual recommendations in these patients are good~     oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions,~     and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple).~     Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g.~     pilocarpine) are less used in terminally ill patients due to cost and secondary effects.~      The purpose of this randomized parallel clinical trial is to determine if a new recipe of~     gelatin with orange juice, cardamome and ginger is more effective in the control of~     xerostomia than the usual treatment of camomile infusion with lemon juice against.~     Treatments will be consumed ad libitum during one week. The main outcome is the subjective~     assessment of dry mouth at end of treatment.~   "
87204|NCT01915953|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
87205|NCT01915940|"~     The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is~     non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.~   "
87206|NCT01915927|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell~     transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a~     single dose of 20 million cells. Twenty adult patients (age 18 years or older) with~     refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will~     undergo standard adjuvant therapy including drainage of infection and placement of a~     draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post~     placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A®~     fistula plug as per current clinical practice. The subjects will be subsequently followed~     for fistula response and closure for 24 months. This is an autologous product derived from~     the patient and used only for the same patient.~   "
90126|NCT01877629|"~     To explore the pharmacokinetics (PK) of a single dose of two different formulations of~     ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a~     single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.~   "
87207|NCT01915914|"~     This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE,~     MAINTENANCE and FOLLOW-UP.~      Subjects will complete the SCREENING phase to check the eligibility within 7 days after they~     sign the written informed consent form. All eligible subjects will be enrolled in ACUTE~     phase to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The~     efficacy and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until~     Treatment Success which depends on which time point comes first. Then subject can get into~     the MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily~     twice a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The~     treatment duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in~     MAINTENANCE phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that~     depends on which time point comes first. If subjects don't experience relapse during~     MAINTENANCE phase, subsequent FOLLOW-UP phase applying emollient twice daily won't be longer~     than another 12 weeks.~      Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up~     to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After~     randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly~     plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring~     sites (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP~     phase, all subjects apply emollient twice daily up to 12 weeks.~      This study will enrol 120 subjects, and propose at least 80 subjects to be randomized.~      Study Endpoints/Assessments:~      Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE~     phase.~      Secondary endpoints are:~        1. Median time to the first relapse of AD during the whole study (including maintenance~          phase and follow-up phase.~        2. Numbers of recurrent patients at the end of MAINTENANCE phase;~        3. Numbers of recurrent patients at the end of FOLLOW-UP phase;~        4. The effective rates (proportion of treatment success patients) during ACUTE phase~          (V3, W-2±2days;V4, W0±2days )~        5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase,~          FOLLOW-UP phase respectively);~        6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening /~          lichenification and abnormal pigmentation changes during the whole study duration~          (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively);~        7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase;~        8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;~        9. Subjects' post-study evaluation to drugs.~   "
87208|NCT01915901|"~     The primary objective of the study is to determine the effect of bismuth subsalicylate~     (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in~     healthy volunteers receiving TECFIDERA™ (dimethyl fumarate [DMF]; also known as BG00012)~     twice daily (BID) The secondary objectives of this study in this study population are: To~     characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on~     the frequency, severity, and duration of GI-related events and to evaluate GI-related events~     that lead to discontinuation of DMF.~   "
87209|NCT01915888|"~     This study aims to estimate the clinical and cost impact of Rotarix vaccinations among~     children aged less than 5 years using insurance claims data from commercial plans and~     Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination~     will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g.,~     2008 onward).~   "
87210|NCT01915875|"~     The purpose of this study is to evaluate the impact of the global approach to the pain in~     cystic fibrosis patients with chronic or intermittent pain. The patients will receive in~     addition to an usual pharmacological and psychological management, sophrology sessions at~     home. The results of this study will provide a new strategy of management of the patient's~     pain.~   "
87211|NCT01915862|"~     The purpose of this study is the evaluation and comparison of blood pressure variability~     indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure~     monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.~   "
87212|NCT01915849|"~     The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption~     immediately after a single dose (immediate effect) and 6 hours following the dose (after~     multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).~   "
87213|NCT01915836|"~     The purpose of this study is to test a web-based video game to help cancer patients quit~     smoking. The investigators are interested in what participants like and do not like about~     the game.~   "
87214|NCT01915823|"~     The purpose of this study is to determine if Dymista nasal spray is better and safer than~     placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.~   "
87215|NCT01915810|"~     The goal of this research study is to better understand if taking part in physical activity~     might help smokers quit.~   "
87216|NCT01915797|"~     The overall project goal is to build a database of childhood cancers associated with~     developmental anomalies; it aims at identifying new syndromes of genetic predisposition and~     at enabling the further study of their molecular basis.~   "
87217|NCT01915784|"~     Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with~     COPD~   "
87218|NCT01915771|"~     Objectives:~      To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral~     capsule doses of 20 mg lomitapide.~   "
87219|NCT01915758|"~     This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase~     I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design~     consisted of the following periods: screening, induction, rest, challenge, and rechallenge~     (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study~     expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive~     repeated 24-hour study patch applications; after patch removal, the sites were irradiated~     with ultraviolet B light (UVB) and visible light (VIS) during the induction period~     (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS~     during the challenge and rechallenge periods. Each application site was observed~     approximately 1, 24, 48, and 72 hours later for signs of inflammation.~   "
87220|NCT01915745|"~     The purpose of the study is to show that the standardized sending of SMS improve the bone~     mineral density (BMD) screening of patients seen in the Emergency department for low trauma~     fracture.~   "
87221|NCT01915732|"~     This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the~     efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in~     the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects~     will be enrolled, 510 per study arm. The subjects will be males and females between 12 and~     45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne~     vulgaris.~      Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate~     gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects~     will be evaluated for change in lesion counts, investigator's static global assessment~     (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2,~     4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be~     performed at every study visit.~   "
87222|NCT01915719|"~     Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy~     only, for immuno-compromized patients with acute respiratory failure~   "
87528|NCT01911676|"~     This study involves an interlinked design to determine the dose associated with optimal~     activity and occupancy of the Glyt1I PF-03463275 in healthy subjects and schizophrenia~     subjects and to test this dose in combination with cognitive remediation in the treatment of~     cognitive impairments of Schizophrenia.~   "
87224|NCT01915693|"~     The single most distressing symptom for more than 70% of patients with oesophageal cancer is~     difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This~     causes severe restrictions on food intake, physical activity, social functioning and overall~     quality of life. Amongst the more effective treatments for improving swallowing, is the~     insertion of a metal stent across the blocked part, which then self-expands to open up the~     gullet (Self Expanding Metal Stent or SEMS). The addition of radiotherapy may help to~     improve the problems caused by dysphagia and provide an additional survival benefit.~      The purpose of this study is to test the impact of adding radiotherapy to SEMS on:~        -  the length of time swallow remains improved for~        -  quality of life~        -  survival~   "
87225|NCT01915680|"~     The purpose of the study is to investigate the IOP difference between normal and~     glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing~     different standard yoga asanas. The IOP of participants will be measured prior, immediately~     at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting~     position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga~     asanas will be tested.~   "
87226|NCT01915667|"~     The purpose of the study is to evaluate the amount of compound present in the blood~     (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a~     capsule in fasted conditions in male healthy subjects.~      Also, the effect of food on the bioavailability of the tablet formulation will be studied as~     well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule~     or tablet.~   "
87227|NCT01915654|"~     The purpose of the transfusion of packed red blood cell is to overcome acute or chronic~     anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase~     oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field~     particularly favorable to the development of tissue hypoxia, which is associated with~     increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues~     at the preoperative period is accompanied by a significant reduction of these major~     complications.~      Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood~     cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious~     effect of transfusion, especially in patients with poor condition, related to storage time.~     Indeed, during storage, impaired blood-related storage is created. It is metabolic,~     biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery~     where patients are suitable for transfusion RBC, have focused on the effect of transfusions~     on consumption and the transport of oxygen to demonstrate the impact of conservation lesions~     on their role in vivo. In particular, a single-center retrospective American study showed~     reduction of postoperative complications in patients who received RBC under 14 days.~      However one of the confounding factors present is that all transfused RBCs are not~     leukoreduced (unlike the French transfusion policy). In addition, the greater part of the~     clinical studies are controversial. That is why we aim to assess, through a retrospective~     study of data, the impact of transfusion of red red blood cells within 14 days of~     post-operative morbidity and mortality, compared to the usual transfusion practice in~     cardiac surgery patients.~   "
87228|NCT01915641|"~     We have reported that CPAP treatment improved the walking capacity of overlap syndrome~     patients.~      However, the previous study was not randomized, double blinded study. Therefore, we design a~     prospective, randomized, double blinded, controlled, cross-over trial to confirm this~     finding.~   "
87229|NCT01915628|"~     Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology~     centers. The e-BioMatrix data will be compared with a historical control group, the Cypher~     arm of the Biosensors Leaders study consisting of 313 patients. All patients will be~     followed for up to 2 years.~   "
87230|NCT01915615|"~     Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most~     frequent cause of sudden cardiac death (SCD) in the young. It is characterized by~     unexplained left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and~     myofibrillar disarray. While the majority of patients remain asymptomatic, prognosis is poor~     in a subset who present with SCD or progress to heart failure (HF). Current methods to~     predict risk of these adverse events and to target therapy are limited. Current medical~     therapy does not protect against SCD, nor does it prevent development of HF. Therefore, the~     identification of novel risk markers would help develop therapeutic targets aimed at~     altering the phenotypic expression to impact the natural history, especially SCD and HF.~     Cardiovascular magnetic resonance (CMR) is emerging as a powerful tool for diagnosis and~     risk stratification in HCM including assessment of LV mass and pattern of hypertrophy. Late~     gadolinium enhancement by CMR is a marker of focal myocardial fibrosis which is thought to~     underlie the arrhythmogenic substrate as well as promote development of HF. The~     investigators hypothesize that HCM patients with a higher primary outcome event rate can be~     identified by novel CMR findings. The majority of cases of HCM are autosomal dominant and~     about 60% are caused by mutations in genes encoding cardiac sarcomeric proteins. However,~     the relationship between genetic mutation, disease phenotype, and clinical outcomes remains~     poorly understood. The investigators hypothesize that HCM patients with sarcomeric HCM~     mutations will have a higher primary outcome event rate and more marked myocardial pathology~     on CMR than those without. Furthermore, there may be a link between sarcomeric mutations and~     fibrosis, as mutation carriers with overt HCM as well as those without hypertrophy have~     elevated markers of collagen turnover. The investigators therefore hypothesize that serum~     biomarkers of collagen metabolism in HCM will predict outcomes. Thus, the Specific Aim is to~     develop a predictive model of cardiovascular outcomes in HCM by: 1) using exploratory data~     mining methods to identify demographic, clinical, and novel CMR, genetic and biomarker~     variables associated with the outcomes and 2) develop a score from the predictive model that~     can be used to assess risk given a patient's combination of risk factors, thus establishing~     the evidence base to enable clinical trial design to reduce morbidity and mortality in HCM~     in a cost-effective manner.~   "
87231|NCT01915602|"~     This is a study to investigate the potential clinical benefit of refametinib when given in~     combination with sorafenib as first line treatment in patients with unresectable or~     metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages.~     Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to~     receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15~     patients at Stage 1 show at least partial response according to an objective criteria to~     evaluate tumor size based on contrast enhancement [modified response evaluation criteria in~     solid tumors (mRECIST)] assessed by external independent radiologists.~      Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. By~     specifically targeting these proteins, refametinib in combination with sorafenib may stop~     cancer growth. The growth of the tumor may be decreased by preventing these specific~     proteins from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on~     the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy~     with refametinib in combination with sorafenib improves the response rate in this patient~     population compared to historical results observed with the sorafenib only.~   "
87232|NCT01915589|"~     This is a study to investigate the potential clinical benefit of refametinib in patients~     with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in~     2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this~     study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of~     15 patients at Stage 1 show at least confirmed partial response (PR) according to modified~     response evaluation criteria in solid tumors (mRECIST) assessed by central image review.~      Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. By~     specifically targeting these proteins, refametinib may stop cancer growth. The growth of the~     tumor may be decreased by preventing these specific proteins from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on~     the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy~     with refametinib improves the response rate in this RAS mutation patient population.~   "
87233|NCT01915576|"~     This is the first study where BAY1125976 is given to humans. Patients (all comers) will~     receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine~     the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative~     bioavailability of liquid service formulation and tablets will be determined.~      After the MTD is defined breast cancer patients with and without AKT1 mutation will be~     treated.~      The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic~     parameters and tumor response of BAY1125976.~      BAY1125976 will be given daily as single oral application. Treatment will be stopped if the~     tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the~     patient decides to exit treatment.~   "
87234|NCT01915563|"~     To evaluate if a rest period before extubation after a successful SBT trial could reduce the~     extubation failure rate.~   "
87235|NCT01915550|"~     Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show~     insulin resistance may be equivalently effective to further raising the insulin dose~   "
87236|NCT01915537|"~     A prospective, multi-centric, cohort study to observe the efficacy difference between~     intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever~     rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor~     prognostic factors.Primary objective is compare the difference of clinical remission rate~     between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor~     prognostic factors at week 30.~   "
87237|NCT01915524|"~     The purpose of this study is to determine whether the new RNActive derived lung cancer~     vaccine CV9202 in combination with local radiation therapy is safe, tolerable and~     immunogenic for the consolidation and maintenance treatment of stage IV non small cell lung~     cancer (NSCLC) after first-line chemotherapy or therapy with an EGFR tyrosine kinase~     inhibitor.~   "
87238|NCT01915511|"~     This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic~     Pulmonary Fibrosis (IPF) and the treatment and management efforts applied throughout study~     follow-up, clinical outcome events and patient reported outcome data. Blood samples will be~     collected periodically throughout the study for use in future research efforts.~   "
87239|NCT01915498|"~     Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD,~     and clinical activity evaluation of orally administered AG-221 in subjects with advanced~     hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation~     phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose~     (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical~     activity of AG-221 in select populations.~   "
87240|NCT01915485|"~     Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in~     its membrane. Furthermore, very little is available to treat patients who have disease~     progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA~     Tyr3-octreotate which is a ligand to somatostatin receptors.~   "
87241|NCT01915472|"~     This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed~     of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is~     a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made~     by the immune system. They bind to substances that don't belong in the body to prevent harm~     to the body. The antibody in this study was designed to bind to a marker located on~     colorectal cancer tumors. The antibody was originally made from mouse proteins, but was~     changed in the laboratory to be more like human antibodies. This study will investigate how~     IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see~     if IMMU-130 is safe and effective.~   "
87242|NCT01915459|"~     The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to~     Botox® reducing upper limb muscle tone in post stroke patients.~   "
87243|NCT01915446|"~     This study aims to investigate the predictive value of novel biomarkers and~     contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and~     intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair~     (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for~     renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid~     binding protein (i-FABP)) and local tissue perfusion will be assessed using~     contrast-enhanced ultrasonography (CEUS).~      The ultimate goal of this study is an early identification of patients developing one or~     both of these complications, which may facilitate a timely intervention to improve outcome.~   "
87264|NCT01915173|"~     The purpose of this study is to investigate the effects of a widely available over the~     counter supplement marketed for heartburn symptoms on symptoms and health-related quality of~     life in patients with gastroesophageal reflux disease (GERD). This study is designed as a~     pilot trial to assess safety and feasibility and to provide preliminary estimates of effect~     sizes.~   "
87307|NCT01914614|"~     The purpose of this research is to better understand the relationship between employment and~     breast cancer. Research is being conducted to understand how workplace factors influence~     breast cancer patients' ability to adhere to recommended cancer treatment and effectively~     recover from cancer. Investigators hope to use the findings from the study to help working~     breast cancer survivors make informed decisions about treatment and employment in~     collaboration with their employers and healthcare providers.~   "
87244|NCT01915433|"~     Based on favorable preliminary data from ongoing studies testing the safety and tolerability~     of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the~     investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls~     Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo~     plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of~     life scores as measured by fatigue severity scale score and MS quality of life 54 physical~     and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue~     and the diagnosis secondary and primary progressive MS, progressive relapsing MS or~     relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or~     greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls~     diet (modified paleolithic diet) groups will be instructed in completing a daily food log~     and receive coaching from registered dieticians who are expert in motivational interviewing.~     The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and~     inflammation, blood sugar and insulin levels will be monitored. Additional blood will be~     frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed~     using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function~     will be done at baseline and 12 weeks. Outcome measures will be change in quality of life~     and fatigue, endothelial function and blood biomarkers between enrollment and end of study~     at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced~     fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks~     and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic~     diet) groups will experience more improvements in quality of life and reduced fatigue and in~     biomarkers than the usual care group experiences at 12 weeks. The usual care group will be~     given instruction in following both the wahls paleo plus and the wahls diet plans and how to~     utilize the daily food logs at the end of study visit. The usual care group will receive one~     nutrition coaching call to assist with implementation of the study diet.~   "
87245|NCT01915420|"~     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting~     bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients~     with complex de novo native coronary artery lesions in all-day clinical practice.~   "
87246|NCT01915407|"~     To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet~     dysfunction.~   "
87247|NCT01915394|"~     The principle purpose of this multicenter trial is to determine the definition, timing and~     the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose~     of the trial is to determine the prevention strategies of further spread of Respiratory~     Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).~   "
87248|NCT01915381|"~     AIM: Improve adherence to physical activity in people with Intellectual disabilities with a~     Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People~     with intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA~     ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables~     study. Inferential statistics will be made between intervention of key variables and outcome~   "
87249|NCT01915368|"~     The investigators will conduct a proof-of-concept study to provide preliminary evidence of~     efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute~     stroke rehabilitation.~   "
87250|NCT01915355|"~     The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye~     Laser for the treatment of onychomycosis, or nail fungus.~      Hypothesis: Complete nail clearance will occur in approximately half of patients after 3~     laser treatments.~   "
87251|NCT01915342|"~     The overall aim of the proposed study is to determine optimal parameter of focal muscle~     vibration for improving spasticity and identify neurophysiological mechanism in healthy~     subjects.~      In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz~     frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity,~     H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be~     recorded pre, during, and post vibration.~      In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm~     amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre,~     during, and post vibration.~      In investigation II, subjects will undergo focal muscle vibration with predetermined~     parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor~     evoked potential at mGCM will be recorded pre, during, and post vibration.~   "
87252|NCT01915329|"~     The purpose of this study is to test a specific nerve stimulation protocol as therapeutic~     option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper~     extremity.~   "
87253|NCT01915316|"~     The purposes of this study are to: i) confirm and improve the accuracy of the correlation~     between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as~     determined through pathology; and ii) determine the levels of zinc in prostate tissue~     declared as non-cancerous by pathology and located in the vicinity of tissue declared as~     cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous~     tissue are lower (statistically significantly) than the levels for benign tissue not in the~     vicinity of cancerous tissue.~   "
87254|NCT01915303|"~     This study is to assess whether pasireotide alone and combined with cabergoline will give~     reliefs on patients with recurrent, persistent and newly diagnosed Cushing's disease. The~     study will also assess study drug safety, the changes in Quality of Life and on clinical~     signs and symptoms of Cushing's disease.~   "
87255|NCT01915290|"~     This is a substudy of the Generation-100 study (NCT01666340). Self reported physical~     activity versus objectively measured physical activity and its correlation to maximal oxygen~     uptake in an elderly Norwegian population (observational study).~   "
87256|NCT01915277|"~     The purpose of this Phase I study is to determine the safety of a drug called~     dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for~     neonates and infants undergoing corrective cardiac surgery that requires the use of~     cardiopulmonary bypass for congenital cardiac problems. This study will also design and~     validate a dosing schema for the use of DEX as described above.~   "
87257|NCT01915264|"~     The study is designed as non interventional to collect data on the safety especially, severe~     hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of~     acarbose/metformin fixed-dose combination under real-life treatment condition in large~     sample of type-2 diabetes patients in India. The study objective is to evaluate severe~     hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as~     adverse events. The study will begin after the study approval by ethics committee. All~     patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M~     will be included in study after taking the informed consent. Patients will be observed for~     up to 24 weeks (2 weeks).The study involves general examination of patients, collection of~     data like history of disease, concomitant medication, drug dose etc. The study is planned to~     enroll 10000 subjects from multiple study centers spread across India. The study data will~     be analyzed with appropriate statistical methods.~   "
87258|NCT01915251|"~     Background:~      - Vaginal yeast infections are caused by a fungus called Candida. Candida can live~     harmlessly in the vagina, but most women will have symptoms from a vaginal yeast infection~     at some point during their life. Antibiotics increase the risk for yeast infections, but it~     is unclear why. They may disrupt the balance of healthy bacteria in the vagina. This could~     make it harder for the body to fight off yeast infections. Researchers will give healthy~     women a common antibiotic or a placebo. They will study how the antibiotic affects bacteria~     and yeast in the vagina and other parts of the body. This will let researchers study the~     normal changes of healthy bacteria and yeast over time.~      Objectives:~      - To see how the study drug changes healthy bacteria in the vagina, and how these changes~     may increase the risk for yeast infections.~      Eligibility:~      - Healthy women ages 18 to 40 who are not allergic to penicillin.~      Design:~        -  Participants will be screened with medical history, physical exam (including vaginal~          exam), blood tests and tests for sexually transmitted diseases.~        -  Participants must take birth control pills for at least 3 months before, and during the~          study.~        -  Participants will take the study antibiotic or placebo for 10 days.~        -  Participants will have 7 study visits over 3 months. Visits will be timed around~          participants menstrual cycles.~        -  At the visits, participants will answer questions about their health and undergo tests.~          These may include swabs of the vagina, mouth and skin as well as blood tests. Vaginal~          fluid, saliva and urine will also be collected.~        -  Between visits, participants will collect stool and vaginal samples at home and bring~          them to the next clinic visit.~   "
87259|NCT01915238|"~     Background:~      - The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were~     age-related macular degeneration (AMD) and cataracts. Participants in that study took~     supplement pills and some participants had additional pictures taken of their eyes. That~     study is now over. Researchers want to do a follow-up study after participants finish taking~     the pills, to see if they cause long-term effects on AMD. This study will be combined with~     follow-up visits of the AREDS2 study if possible.~      Objectives:~      - To learn more about the effect of oral supplements on AMD.~      Eligibility:~      - People who completed the AREDS2 study.~      Design:~        -  Participants will have up to 2 study visits over 6 18 months.~        -  Each visit will last up to 5 hours. The visits will be combined with annual follow-up~          visits in the AREDS2 study if possible.~        -  At each visit, participants will undergo an eye exam and photography.~        -  The eye exam includes testing sight, measuring eye pressure, and checking eye~          movements. To examine the inside of the eye, the pupil will be dilated with eye drops.~        -  Photographs of the inside of the eye may be taken during the eye exam and while the~          eyes are dilated.~        -  A contact lens may be placed on the eye briefly to look at the retina at the back of~          the eye.~   "
87260|NCT01915225|"~     Background:~      - Recent advances in cancer research have led to new therapies to treat the disease. It is~     important to continue these advances and discover new ones. To do that, researchers need~     tissue samples from solid tumors. This study will collect such samples from people already~     scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).~      Objectives:~      - To collect tissue samples for use in studying new ways to treat tumors.~      Eligibility:~      - Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled~     to have surgery or a biopsy at the NIHCC.~      Design:~        -  Before their procedure, participants will have a small blood sample taken.~        -  Some participants will undergo leukapheresis. In this procedure, blood is removed~          through a tube in one arm and circulated through a machine that removes white blood~          cells. The blood, minus the white blood cells, is returned through a tube in the other~          arm. The procedure takes 3 4 hours.~        -  For all participants, during the surgery or biopsy, pieces of the tumor and pieces of~          normal tissue near it will be removed for this study. The rest of the tumor or~          precancerous growth will be sent to a lab for analysis.~        -  Participants will return to the clinic about 6 weeks after the operation for a routine~          checkup. Some may have to return for additional follow-up.~   "
87261|NCT01915212|"~     Background:~      - Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause~     serious infection in newborns and in people with weakened immune systems. It increases the~     risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine~     that could prevent genital herpes could improve the general health of the world s~     population. Researchers want to study whether a new vaccine, HSV529, which may be used in~     the future to prevent herpes infections, is safe.~      Objectives:~      - To test whether a new herpes vaccine is safe.~      Eligibility:~      - Healthy adults 18 40 years old.~      Design:~        -  Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone~          calls over 1 year.~        -  Each vaccination visit will last about 4 hours.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have a blood sample taken.~        -  Participants will be given the vaccine or a placebo, by injection from a needle. They~          will be monitored for 30 minutes to check for any allergic reaction.~        -  Participants will be given a diary card to record any symptoms they may feel later.~        -  At follow-up visits, participants will give a blood sample and answer health questions.~        -  In the phone calls, participants will answer health questions.~   "
87262|NCT01915199|"~     The implementation of lifestyle modifications, home blood pressure (BP) measurement, and~     optimization of antihypertensive drug therapy have been shown to improve BP control in~     tightly controlled research settings. The investigators objective is to determine the effect~     of these interventions in a primary care setting, with the family practitioners and nurses~     serving as the interventionists. The investigaotrs hypothesis is that a comprehensive~     intervention performed in a primary care setting would lead to better blood pressure~     control.~   "
87263|NCT01915186|"~     The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve~     markers, ovarian response to gonadotrophins and cycle outcomes in patients with normal and~     poor ovarian reserve.~      Study Hypotheses:~        1. DHEA supplementation would improve markers of ovarian reserve and ovarian response to~          low dose FSH stimulation in both normal and poor responders~        2. DHEA supplementation would improve IVF cycle outcomes~   "
91207|NCT01863394|"~     The objective of this study is to determine the efficacity of a community strategy for~     screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their~     mothers' compared with a community screening strategy conducted by Community Health Workers.~   "
87265|NCT01915160|"~     Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health~     disorder at any point in time. Effective treatments exist for these disorders, but children~     and families who seek services rarely receive them; mental health providers need more~     support in the delivery of these interventions to ensure that children and families are~     receiving the best quality care. This project aims to improve the delivery of best practices~     for families who seek mental health care by developing creative, technology-based resources~     for providers. Once we have completed development of the tablet-based resources, we will~     conduct a small randomized study with 20 families to examine the feasibility and prepare for~     a large study to test the effectiveness of the resources.~   "
87266|NCT01915147|"~     The study is intended to explore changes in the composition and quantity of gut bacteria~     subject to treatment with strong pain medication. Two pain medications will be compared (OXN~     PR and OxyPR). Other gastrointestinal parameters will be assessed.~   "
87267|NCT01915134|"~     The investigators designed this study to evaluate the efficiency and the acute toxicities of~     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic~     nasopharyngeal carcinoma (NPC).~   "
87268|NCT01915121|"~     The study main objectives are to enhance treatment decision making and improve quality of~     life and post-treatment health care among patients diagnosed with invasive bladder cancer.~      Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more~     common among men than women and 90% of all patients are over the age of 55. Surgery to~     remove the bladder followed by one of three diversion techniques (i.e., ileal conduit,~     continent reservoir, and neobladder) is the standard therapy following invasive bladder~     cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment~     on patients' QOL and adjustment can be devastating. This impact significantly varies by~     treatment option. Treatment decision making in for BL Ca is difficult at best and~     potentially susceptible to a number of cognitive and affective factors (e.g., patients'~     emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential~     life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of~     different treatment options adds to the overall distress and may impair effective~     decision-making. In spite of increasing efforts in health communication and patient~     education, no study has examined treatment decision making among invasive bladder patients~     or has provided an educational intervention to facilitate treatment decision making among~     this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes~     the role of cognitive and emotional factors in decision making, we have designed and pilot~     tested the acceptability of a preliminary educational and training experiential intervention~     (ETE) to address this gap in the literature. The ETE intervention uses new and innovative~     educational strategies and methods to educate patients about their treatment options and to~     facilitate their treatment decision making.~   "
87269|NCT01915108|"~     This study was designed to determine the optimal dose of remifentanil that can prevent the~     complications associated with the removal of LMA without delaying emergence.~   "
87270|NCT01915095|"~     The goals of this study are to examine the physiology of Central Nervous System pathways~     contributing to the control of upper and lower extremity movements after SCI, and to promote~     the recovery of extremity movements by using non-invasive brain stimulation and motor~     training.~   "
87271|NCT01915082|"~     This study investigates possible beneficial effects of peri-operative treatment (i.e.~     pre-transplant initiation and prompt post-transplant continuation) with azithromycin in lung~     transplantation. Our hypothesis is that this therapy will improve early allograft function~     and outcome following human lung transplantation.~   "
87272|NCT01915069|"~     Combined oral contraceptive pills (COCs) are the most commonly used hormonal form of birth~     control in the United States with at least 87% of women of reproductive age reporting oral~     contraceptive use at some point in their lives (9). Despite their frequent use, the six and~     twelve month discontinuation rates for oral contraceptive pills are 31 and 47 % respectively~     (17), with common reasons for discontinuation attributed to the side effects of abnormal~     bleeding, headache, and weight gain.~      Additionally, COCs are contraindicated in certain groups of women as outlined by The Centers~     for Disease Control Medical Eligibility Criteria (11). Given the high prevalence of oral~     contraceptive users who commonly discontinue use secondary to side effects or who are not~     eligible for use as a result of underlying health conditions, the development of novel oral~     non-hormonal methods that are equally effective at pregnancy prevention are warranted.~      This current study aims to evaluate the effect of an FDA approved drug, Cilostazol, on human~     oocyte maturation. Such a study has not been conducted to date. If Cilostazol demonstrates~     an ability in humans to affect resumption of meiosis, then this non-hormonal agent could be~     uses as a possible contraceptive agent in the future. This knowledge would have profound~     reproductive health implications.~      The investigators propose that women undergoing treatment with the FDA approved dose of~     100mg PO every 12 hours of Cilostazol will demonstrate an impairment of egg maturation in~     comparison to paired historic controls following ovarian follicle stimulation.~   "
87273|NCT01915056|"~     The purpose of this study is to determine whether information regarding GA and GA-driven~     interventions improves outcomes in older cancer patients receiving first-line or second-line~     chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and~     early termination of treatment in patients with and without GA-driven interventions. The~     investigators will identify information that will be useful based on questionnaire responses~     and blood tests. These results will be used to better understand which recommendations and~     interventions will benefit older cancer patients. It is our hope that these tools, which are~     well-established at identifying areas of risk, will provide meaningful opportunities for~     intervention to promote your safety during cancer management. The investigators will be able~     to use this information to teach others on how to best care for adults aged 70 and older~     with cancer.~   "
87300|NCT01914705|"~     The objective of the study is to investigate whether or not there will be a significant~     difference between landmark vs. ultrasound guided approach during Subclavian Central Venous~     Catheter (SCVC) placement in terms of the success rate, the time it takes to perform the~     procedure and the complication rate. By using ultrasound to identify anatomical structures~     that are not seen during the landmark approach, the investigators hypothesize that both the~     procedural time and the complication rate of ultrasound guided approach should be lower than~     the landmark approach. The investigators hypothesize that the success rate will be higher in~     the ultrasound group.~   "
87301|NCT01914692|"~     Gastric cancer radical surgery related complications are common.Somatostatin is a~     conventional medical therapy for bleeding.This study explore the effect of Somatostatin for~     Advanced Gastric Cancer After D2 Lymph Node dissection.~   "
87487|NCT01912222|"~     This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or~     hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate~     hepatic impairement or severe hepatic impairment) as defined by the National Cancer~     Institute (NCI) Organ Dysfunction Working Group.~   "
87274|NCT01915043|"~     Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in~     the lymphatic system and can develop immediately after surgery / radiotherapy of breast~     cancer, or may appear months later. In the literature there are numerous educational~     recommendations to avoid the appearance BCRL, but there is a lack of adherence to these~     recommendations. With the increase of mobile technologies among adults, the mobile devices~     can be an effective method to meet their education.~      Objective: To determine the effectiveness of therapeutic adherence a brief educational~     intervention through a smartphone-based application in the prevention of lymphedema in women~     with mastectomies.~      Method: 100 women survivors of breast cancer will be randomized to a group that will receive~     lymphedema prevention education and an app specific for better adhesion compared to the~     control group will receive education only. They will be monitored for 28 weeks by specific~     measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema~     disability questionnaire and other measures of fatigue, quality of life and mood related to~     cancer.~      Discussion: The lack of adherence to health education is the main cause of failure in~     maintaining these brief educational interventions, whether the program is beneficial, it~     could be successfully implemented in clinical practice.~   "
87275|NCT01915030|"~     The present study is designed to investigate whether a high protein diet will preserve~     muscle mass during caloric restriction in older adults.~   "
87276|NCT01915017|"~     Many individuals with schizophrenia continue to hear voices, have false beliefs, and~     problems with attention, memory planning and everyday functioning even with medication~     treatment. The process of recovery in schizophrenia involves treating the whole person. This~     study will test a new Multimodal Cognitive Treatment (Mcog). Mcog works around problems in~     attention, memory and planning by using supports in the home such as signs, checklists, and~     alarms to improve everyday functioning. Mcog also helps the individual to examine the~     evidence for their beliefs and to deal with symptoms like voices that are not completely~     resolved with medications. We will compare 4 treatments to determine if this combined~     approach improves both symptoms and functioning for individuals with schizophrenia.~   "
87277|NCT01915004|"~     Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant~     subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient~     clinics. These children present with urinary tract infections (UTIs), abnormal voiding~     habits and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary~     urgency and urinary frequency. Furthermore, the effects of NLUTD on a child's physical~     health, mental health and its potential negative clinical sequelae, which includes upper or~     lower urinary tract damage, must be taken into account when treating these children. These~     patients have complex needs requiring a significant amount of health teaching and it is~     imperative to determine the effectiveness of the various modes of delivering urotherapy. To~     determine the best modality to deliver urotherapy, this trial will compare the effectiveness~     of a 7 minute bladder training video to the effectiveness of standard urotherapy provided at~     a pediatric urology clinic at improving NLUTD/DES symptoms and quality of life in children~     between 5-10 years of age.~   "
87278|NCT01914991|"~     Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic~     intervention aiming to restore mobility using different techniques as stretching, hot packs,~     exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found~     correlating improved joint mobility and the use of these techniques. Application techniques~     of orthoses to reshape the soft tissues have been well detailed, however, no scientific~     evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag~     extension resolution using them as a single treatment has been found.~      Purpose of the Study: The purpose of the study was to test the effectiveness of static and~     dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment~     compared with traditional combined therapies.~      Method: 63 participants were included in the study. Patients who used splints were compared~     to a control group who received conventional treatment. Active and passive mobility were~     measured before the experiment and again three months after. All the patients were measured~     under the same conditions and treated by the same hand therapist. The relationship between~     contracture resolution and function was measured using the DASH Spanish Version.~   "
87279|NCT01914978|"~     The objective of this research is to evaluate the effectiveness of a handbook for parents of~     children newly diagnosed with food allergy. The handbook was developed to provide~     information and strategies to support families in effectively managing food allergies while~     maintaining positive quality of life. Parents of children newly diagnosed with food allergy~     (within the past year) will be randomized into either the treatment condition (handbook) or~     a control condition (management of food allergy as usual). Participants will complete study~     questionnaires online at three time points: baseline (this will be before receiving the~     handbook for the treatment group), post-intervention (2-3 weeks after baseline), and~     follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome~     measures and satisfaction with the handbook. Parents in the control group will receive the~     handbook following the conclusion of their participation in the study.~   "
87280|NCT01914965|"~     The influence of bupropion compared to placebo on the change of apathy as quantified by the~     apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar~     with the daily activities of the subject) in patients with HD after ten (10) weeks of~     treatment.~   "
87302|NCT01914679|"~     The purpose of this study is to evaluate the mechanisms of noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation RINCE)in the management of fibromyalgia. Patients who meet the 1990~     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE~     treatments delivered by a medical device called NeuroPoint. Approximately 20 patients will~     receive a combination of active and inactive (sham) therapy treatments over a 16-week period~     followed by a 4 week post-treatment evaluation. Patients will also undergo three (3)~     functional brain imaging scans while participating in the study: the first prior to the~     commencement of treatment, another mid-treatment; and the third at the completion of the~     treatment period.~      The study's primary outcome measure will be the change from baseline in self-reported~     24-hour average pain intensity. The study's hypothesis is that there will be a change in~     pain intensity as well brain functioning. We do not expect there to be a statistically~     significant improvement in pain intensity due to the small sample but do expect to see~     statistically significant changes in cortical function as measured by EEG and fMRI~   "
87281|NCT01914952|"~     The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate~     (HMB) after the dietary supplement has been administered in different forms. Prior studies~     have indicated that form of administration affects bioavailability of the HMB supplement.~     Therefore the current study will examine the bioavailability of a single dose of HMB given~     as:~        -  1.0g CaHMB in gelatin capsule~        -  0.8 g HMB free acid in a gelcap~        -  0.8 g HMB free acid in water~        -  1.0 g CaHMB in water~        -  0.8 g HMB free acid~      The randomized study will be a crossover design and each study subject will undergo the~     experimental protocol for each of the supplementation forms. Because of the different~     administration forms, the study will be an open label study. Briefly, the fasted~     participants will report to the laboratory in the morning. After an initial blood sample is~     taken, the dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25,~     35, 45, 60, 90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine~     collection will also be performed. Participants will be given a light sack lunch 4 h after~     administration of the dosage and will remain at the laboratory through the 360 min sampling.~     Participants will then be allowed to leave the laboratory and return for the 720 min~     sampling after which the participants can eat an normal evening meal. Participants will~     return to the laboratory fasted the next morning for the final sample. A minimum 48 h~     washout period will be required before the next dosage form is administered and the process~     repeated.~   "
87282|NCT01914939|"~     This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin~     (OT) augmentation, in young adults with autism spectrum disorders. Participants will be~     randomly assigned to receive either a social skills-focused CBT intervention or a stress~     management/relaxation training CBT intervention. Participants will also be randomized to~     receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The~     design of the study will enable examination of the efficacy of CBT for young adults with~     autism spectrum disorders. The design of the study will also allow examination of whether~     oxytocin enhances the efficacy of CBT.~      The investigators will perform functional (fMRI) and structural (MRI) imaging with all~     participants prior to treatment. This will enable examination of the relations between~     measures of brain function and structure, and improvements in target symptoms over the~     course of treatment. The aim is to discover whether there are neural characteristics that~     can identify which participants with autism spectrum disorders are most likely to respond to~     CBT interventions and/or oxytocin treatment.~   "
87283|NCT01914926|"~     Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia~     encountered in the emergency department (ED) and the most common dysrhythmia treated by~     emergency physicians. Atrial flutter is less common than atrial fibrillation but its~     management in the ED is very similar, and the majority of patients with atrial flutter also~     have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the~     primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter~     (AFF). The need for swift, appropriate action by the emergency physician is highlighted by~     the fact that up to 18% of patients with AFF develop potentially life-threatening~     complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory~     failure, angina and myocardial infarction.~      Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the~     ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently~     used calcium channel antagonist.[8] Diltiazem was released by the FDA for treatment of AFF~     in 1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the~     ED management of AFF with rapid rate and its clear superiority over the previously most~     commonly used pharmacologic agent, digoxin.~      To date, only one prospective, randomized trial has compared the effectiveness of a calcium~     channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the~     ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that~     both pharmacologic agents were similarly effective. In order to test this finding, the~     investigators conducted a prospective comparison of metoprolol and diltiazem for the~     management of patients presenting to the ED with AFF with rapid ventricular rate.~   "
87284|NCT01914913|"~     Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is~     the layer of tissue at the back of the inner eye that converts light images to nerve signals~     and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)~     is used for this condition .~   "
87285|NCT01914900|"~     This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and~     5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer. The~     aim is to improve the rate of pathological complete response to induction chemotherapy in a~     molecular enriched population, consisting of patients with tumour harbouring a functional~     p53 protein and/or showing low expression of beta-tubulin II.~   "
87286|NCT01914887|"~     The aims of our study are to evaluate the feasibility and safety of endoscopic injection of~     adipose tissue-derived mesenchymal stem cells in human subjects with moderate active~     ulcerative colitis, assessing the absence of adverse events associated to the~     investigational drug, and to evaluate the efficacy of the treatment to induce remission of~     moderate active ulcerative colitis, by improvements in disease activity index, quality of~     life index, and endoscopic index.~   "
87287|NCT01914874|"~     The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced~     mindfulness-based program that includes mindful exposure to reduce anxiety and avoidance~     of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh~     judgment and self-criticism that is characteristic of people with social anxiety disorder.~   "
87288|NCT01914861|"~     The purpose of this study is to examine a possible link between the time of day of exposure~     to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and~     biological correlates will also be examined from this perspective.~   "
87289|NCT01914848|"~     Multiprofessional Advance Care Planning and shared decision making for end of live care for~     terminal patients and their relatives.~      The aim of this study is to develop, implement and test a complex intervention for improving~     patients' preparation for and participation in end of life decisions. In cooperation with~     local, national and international partners, the investigators will focus on strategies to~     enhance advance care planning and shared decision making on end of life issues, and~     documentation and transferability of end of life decisions across health care settings in~     coordinated approach involving patients, their families and care givers (in and out of~     hospital).~   "
87303|NCT01914666|"~     The purpose of the study is to assess the long term safety of duloxetine in participants~     with Chronic Low Back Pain (CLBP).~   "
87304|NCT01914653|"~     Prospective, single center, postmarket clinical study to obtain clinical experience with the~     use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.~   "
91208|NCT01863381|"~     This research is being done to determine the accuracy of two noninvasive methods of~     measuring the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure~     or ICP.~   "
87290|NCT01914835|"~     Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in~     executive functions and decision-making, which are predominantly managed by the prefrontal~     cortex (PFC) in the brain. However, none study in Neuropsychological Rehabilitation (NR) has~     been done in order to remediate the executive functioning in this population. The aim of~     this research is to investigate the impact of neuropsychological intervention based on the~     stimulation of cognitive functions such as attention, planning, organization, logical~     reasoning, executive functioning, and decision making. For this research it will be proposed~     interventions through motivational strategies and board games, especially chess because it~     has been associated with PFC functioning, since it is a game which requires complex~     cognitive abilities, such as: inhibitory control, mental flexibility, sustained attention,~     future planning and decision-making. There will be two groups of patients with cocaine/crack~     dependence (n = 56), one with NR (group A, n = 28) and another without NR (group B, n = 28).~     Group B will be submitted to the placebo intervention. Both groups will be submitted to an~     extensive battery of neuropsychological tests and psychopathological rating scales before~     and after interventions. A sub-group will also be submitted to functional magnetic resonance~     imaging and biomarkers measures (BDNF and cortisol). The hypothesis is that group A will~     present a pronounced improvement not only on the neuropsychological test but also on the PFC~     functioning in neuropsychological functions compared to group B.~   "
87291|NCT01914822|"~     1. To examine whether Ritalin has analgesic properties in healthy subjects.~        2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a~          broader, non-specific effect on high mental functions.~   "
87292|NCT01914809|"~     Preeclampsia is a frequent pathology. His etiology is doubtful.~      Targets :~      The study target is to identify a risk of preeclampsia group obtained with transcriptom~     analysis from circulating peripheric cells.~      Design:~      Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).~      The study of the transcriptional history of peripheral blood cells of 2patients groups:~        -  A patient group with a preeclampsia before 34 SA~        -  A patient group with a normal pregnancy paired on main confusion factors. Blood~          sampling will be collected at the diagnosis and 8 weeks after delivery.~      Results and perspectives~        -  Obtain a transcriptionnal signature of preeclampsia~        -  To identify new mechanism of the disease~        -  Identification of a specific transcriptom analysis with the comparison after delivery~          For long-term, the target is to identify risk patient in order to conduct easily~          preventive clinical trials in preeclamsia (primary prevention) and to consider a~          specific follow-up for risk patients.~   "
87293|NCT01914796|"~     This study will determine the safety and tolerability of PF-06412562 given orally to healthy~     volunteers. To determine the optimal dose for future studies, the concentration of the drug~     over time will be determined by periodic blood samples. The rate of eye blinks will be~     measured as an indicator of PF-06412562 action on the receptors of interest in the brain.~   "
87294|NCT01914783|"~     The primary hypothesis of the study is that in healthy elderly subjects experimental~     exposure to air pollutants increases sympathetic nervous system activity compared with sham~     (clean air) exposure. The secondary hypothesis of the study is that combined experimental~     exposure to air pollutants (particles + ozone) increases sympathetic nervous system activity~     to a greater extent than does the exposure to particles alone.~   "
87295|NCT01914770|"~     This pooled analysis will assess data from the Phase 3 belimumab registration studies~     BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and~     agreed prior to the unblinding of either study. The primary objective is to evaluate the~     impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus~     (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making.~     Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized~     subjects who received at least 1 dose of study agent. This more severe subpopulation will~     have renal, neurological, haematological, or cardiovascular/respiratory organ domain~     involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A,~     B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic~     acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative~     to the normal range at baseline.~   "
87296|NCT01914757|"~     The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate~     in patients with a history of asthma exacerbations and uncontrolled asthma receiving~     ICS-LABA with or without oral corticosteroids and additional asthma controllers.~   "
87297|NCT01914744|"~     The aim of this study is to prove the superiority of entecavir over lamivudine for~     preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma~     on CHOP/R-CHOP.~   "
87298|NCT01914731|"~     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool~     transplant from a healthy individual to a C. difficile-infected recipient, and has long~     been a successful approach to recurrent/refractory C. difficile. The purpose of this project~     is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can~     be used repeatedly, particularly in those who do not have a healthy intimate partner or~     other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention~     enema, or by the nasogastric route. This study will evaluate the safety and secondarily the~     efficacy of an inoculum administered by frozen orally-administered capsules.~      Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules~      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,~     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.~     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a~     normal bowel status for the individual. Secondary efficacy endpoints include weight,~     subjective well-being and relative clinical improvement per standardized questionnaire, and~     subject qualitative assessment of, and satisfaction with, the transplant procedures.~     Subjects will be monitored for clinical safety by history and standard exams and the~     follow-up questionnaire as well as followed closely by phone and in person.~   "
87299|NCT01914718|"~     The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in~     patients with MYC positive diffuse large B-cell lymphoma.~   "
87497|NCT01912092|"~     The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing~     local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with~     Askina® Calgitrol® Paste.~   "
87308|NCT01914601|"~     Extensive cervical spines movement during endotracheal intubation can result in serious~     neurological injury, especially in the patients with unrecognized cervical spines~     injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited~     because of arthritis, disc disease or a small gap between the occiput and the spinous~     process of the atlas.[3-4]~      Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and~     tracheal axes which minimize the cervical movements, especially in the patients with~     restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of~     AirWay Scope decreases median upper cervical-spine movement during intubation under in-line~     stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video~     laryngoscopes are associated with longer times to tracheal intubation compared with the~     traditional techniques which may be attributed to the variable learning curves of the~     practitioners. [7-9]~      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,~     Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses~     fiberoptic technology to view the larynx with micro camera offers a 160 degree of view~     potentially eliminating the need for neck flexion and head extension. [10]~      To the best of the authors' knowledge, there is no study has evaluated the King vision~     laryngoscope regarding the neck movement during routine tracheal intubation under general~     anesthesia.~   "
87309|NCT01914588|"~     Heart failure is a chronic disease associated with an increasing risk of morbidity,~     disability, repeated hospitalizations and mortality. Telemedicine could promptly identify~     signs of worsening cardiac disease in order to improve elderly patients' home care and~     quality of life by reducing the need of hospital admissions and sanitary costs. The~     investigators present a randomized, parallel-group trial to test the ability of a~     multiparametric remote monitoring system, in addition to standard care, to promptly identify~     worsening of heart failure and prevent hospital admission and mortality.~   "
87310|NCT01913977|"~     This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome)~     treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2~     (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the~     oxygenator Lilliput2 as CO2 remover (Bellco, Italy).~      The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication~     for anticoagulation therapy.~      Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas~     flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the~     patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h.~      A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL)~     are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time~     points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG)~     1.5, 3, 6, 7, 8L/min~      Blood samples are analysed for the different blood gases from which the extraction in the~     CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).~   "
87311|NCT01913964|"~     To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily~     activity, and fatigue in subjects with chronic hepatitis C treated with~     Pegylated-Interferon-α2b and Ribavirin.~   "
87312|NCT01913951|"~     This phase I trial studies the side effects and the best dose of vosaroxin when given~     together with azacitidine in treating patients with myelodysplastic syndromes. Drugs used in~     chemotherapy, such as vosaroxin and azacitidine, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing.~   "
87313|NCT01913938|"~     The purpose of the study is to find out whether non-responsiveness to therapeutic~     recombinant human granulocyte colony-stimulation factor (rhG-CSF) is associated with~     hemophagocytosis in critically ill adult patients with cytopenias.~   "
87314|NCT01913925|"~     The objective of this research is to determine if tyrosine, an amino acid found in~     protein-containing foods, will mitigate the cognitive deficits and adverse effects on~     behavior and mood produced by exposure to military stress. This study was conducted at the~     US Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).~      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain~     neurotransmitter that is critical for the central nervous system (CNS) response to various~     types of acute stress. Psychological stress increases catecholamine turnover in the brain,~     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and~     human studies have shown that tyrosine supplementation can produce beneficial effects on~     cognitive and physiological functions during exposure to a variety of acute stressors.~      This project will determine if volunteers treated with supplemental tyrosine during~     stressful phases of SERE training experience less degradation in cognitive performance and~     mood than volunteers treated with placebo. Tyrosine or placebo will be administered in a~     specially developed food bar provided to volunteers. The bar is part of a prototype of~     ration-component designed for use during assault operations. A between-subjects, double~     blind experimental design will be employed. Tyrosine, an amino acid found in most~     protein-containing foods, has been tested in hundreds of volunteers without adverse effects.~      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80~     volunteers complete the study. They will be tested during several portions of SERE. A~     comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart~     rate data will be collected in a manner that does not interfere with ongoing training.~      Hypotheses:~        1. Exposure to the stressors of SERE school will adversely impact cognitive performance~          and mood of volunteers.~        2. The adverse effects of psychological stress on cognitive performance and mood during~          SERE school will be reduced when volunteers are given supplemental tyrosine compared to~          placebo treatment.~   "
87315|NCT01913912|"~     Stimulants alleviate information processing and task performance deficits in Attention~     Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as~     lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and~     improve classroom performance. Although stimulants have been widely used in treatment of~     ADHD, the exact mechanism action and effect on task performance is not completely known.~      According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty~     regulating their levels of arousal/activation during tasks in response to the changing~     demands of the environment. This leads to problems with downregulating overaroused states~     and upregulating underaroused states. According to this view, stimulants exert their~     therapeutic effect (in part) by optimising arousal/activation levels - especially during~     states of underarousal/activation. Arousal/activation levels can also be altered by~     extrinsic factors such as event rate (ER), e.g., the rate at which information is presented.~     Multiple studies suggest that very fast and very slow events can both cause problems for~     individuals with ADHD, related to overarousal and underarousal state respectively. Putting~     these intrinsic (stimulants) and extrinsic (ERs) factors together leads to the prediction~     that changing the rate at which information is presented in a task may alter the efficacy of~     stimulants and affect the optimal stimulant dose level. More specifically, one dose of~     stimulant that may be optimal on slow ER tasks (as it increases arousal/activation level)~     may be less effective under high ER tasks because in such a setting arousal/activation level~     needs to be lowered and not increased further. Adding stimulants to an already overactivated~     state may exacerbate the associated problems. The implication of this is that a different~     dose of stimulant will be needed under different environmental conditions for optimal~     performance. For example, children with ADHD might require different dosage in the classroom~     setting to optimize performance. In addition, the neuropsychological basis of performance~     deficits and improvement by ER and stimulants are also unclear. According to the SRD model,~     the underlying mechanism can be specific problems in motor activation/preparation or effort~     regulation. Event-related potentials (ERP), pupil size measurements and cardiac measures~     enable us to see objectively how motor activation/preparation and effort are affected by ER~     and simulants.~      In this study the investigators aim to test these predictions of the SRD model and identify~     the neurobiological basis of stimulant action.~   "
87316|NCT01913899|"~     The aim of the study is the measurement of the short term effect of post surgical mirror~     therapy concerning pain intensity and frequency of patients with upper or lower amputation~     in comparison to standard occupational or physical therapy. The hypothesis is that patients~     in the intervention group (mirror therapy) suffer significantly less from phantom limb pain~     and pain attacks within a follow-up period of 4-8 weeks.~   "
87317|NCT01913886|"~     This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal~     stem cells (MSCs) to repair heart function in patients with myocardial ischemia.~   "
87318|NCT01913873|"~     Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury~     is expected. The level of injury can be shown by measuring the blood levels of specific~     molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute~     cardiac care to diagnose a myocardial infarction.~      Postoperative heart infarction remains a frequent and important complication after heart~     surgery.Therefore it is important to recognize any cardiac event in patients who underwent~     heart surgery. Although different diagnostic tools can be used to recognize these events,~     few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction~     after heart surgery.~      In this study the investigators will describe the concentration changes of those cardiac~     biomarkers over time in patients undergoing heart surgery, and the investigators will try to~     establish a upper level value who could indicate heart infarction.~   "
87319|NCT01913860|"~     Background The over use of antimicrobials is recognised as the main selective pressure~     driving the emergence and spread of antimicrobial resistance in human bacterial pathogens.~     Urinary Tract Infections (UTIs) are one of the most common infections presented in primary~     care and empirical antimicrobial treatment is currently recommended. Previous research has~     identified that a substantial proportion of Irish GPs prescribe antimicrobials for UTI that~     are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in~     Ireland.~      Aim To design, implement and evaluate the effectiveness of a complex intervention on GP~     antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial~     consumption when presenting with a suspected UTI.~      Methods The SIMPLE study is a randomised three armed intervention with practice level~     randomisation. Adult patients presenting with suspected UTI in primary care will be included~     in the study.~      The intervention integrates components for both GPs and patients. For GPs the intervention~     includes interactive workshops, audit and feedback reports and automated electronic prompts~     summarising recommended first line antimicrobial treatment and, for one intervention arm, a~     recommendation to consider delayed antimicrobial prescribing. For patients multimedia~     applications and information leaflets are included. A minimum of 920 patients will be~     recruited through 30 practices. The primary outcome is change in prescribing of first line~     antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary~     Care in Ireland. The intervention will take place over 15 months. Data will be collected~     through a remote electronic anonymised data extraction system (iPCRN), a text messaging~     system and through GP and patient interviews and surveys. The intervention will be~     strengthened by the implementation of a social marketing framework and an economic~     evaluation.~   "
87320|NCT01913847|"~     The purpose of this study is to investigate the safety and clinical efficacy of HGP1207~     (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.~   "
87321|NCT01913834|"~     Osteoporosis is a reduction in bone density that increases the risk of fractures;~     particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million~     women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70,~     two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the~     associated fractures costs the NHS more than two billion pounds per annum.~      Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor~     to be taken by injection. It is currently the only drug available which promotes the~     deposition of new bone as opposed to preventing resorption. This is the drug treatment we~     will be studying in this clinical trial.~      The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs~     tends to be delivered by injection, as is currently the case for teriparatide. Injections~     have numerous limitations and are disliked by patients.~      This trial will assess how well the nasal spray devices work, how long the drug stays in the~     nose and also how well the drug enters the bloodstream.~   "
87322|NCT01913808|"~     Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main~     consequence of perioperative anaemia is an increased risk of red blood cell (RBC)~     transfusions. Allogeneic RBC transfusion and anaemia are associated with higher~     postoperative mortality and morbidity.~      The aim of this study was to compare the efficacy of postoperative i.v. ferric~     carboxymaltose (FCM) and oral ferrous glycine sulphate (FS) for early improvement of~     postoperative anaemia after total knee arthroplasty and whether iron treatment could~     facilitate recovery from surgery.~   "
87323|NCT01914562|"~     This is an open label, randomized, balanced, single center, single dose, trial to assess the~     pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted~     condition) and following a high fat, high calorie meal (fed condition) in a 2-period,~     2-sequence, crossover manner.~   "
87324|NCT01914536|"~     This project is an observational prospective study in which patients affected by an adult~     onset Pompe disease will be followed-up during three years using different clinical,~     analytical and radiological tests in order to know which is the natural history of the~     disease and which is the impact that treatment with recombinant enzyme has in the~     progression of the disease.~   "
87336|NCT01914367|"~     Six identical female twins aged 9-13 years will participate. One sib of each twin pair will~     be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib~     will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood~     samples will be taken (the first prior to vaccine administration, the second and third 7~     days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the~     magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the~     cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31~     and -33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in~     the first place (and eventually after the 2nd dose also) will be examined for for the usage~     of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light~     chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the~     cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a~     series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a~     three-dose schedule of either Cervarix or Gardasil will be examined.~      The duration of the study is approximately 187 days. Five study visits will take place, over~     a time period of 6.5 months, followed by a telephone call after 12 months.~      The purpose of the study is to learn more about the molecular mechanisms underlying the~     cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with~     the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).~   "
87325|NCT01914523|"~     Failure to successfully intubate the trachea and secure the airway remains a leading cause~     of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the~     concept of endotracheal intubation was developed, 100 years ago the procedure was performed~     blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization~     of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view~     constitutes the main reason for difficult intubations [6].~      Video laryngoscopes provide an improved view of the glottis, as the camera is a few~     millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes~     has superior glottis view and ease of tracheal intubation compared with the traditional~     Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer~     time to tracheal intubation compared with the traditional techniques which be explained with~     the variable learning curves of the practitioners. [10]~      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,~     Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices~     that claim to provide the perfect view for intubation via use of video and digital~     technology.~      The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that~     attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and~     house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED~     light source.~      Up to best of the authors' knowledge, there is no current published or ongoing randomized~     controlled comparative study of the use of King Vision laryngoscope with traditional~     laryngoscope and other video laryngoscopes for endotracheal intubation.~   "
87326|NCT01914510|"~     This is a phase 2 study to see how useful, safe, and tolerable an investigational drug~     called ENMD-2076 is in treating patients with ovarian clear cell carcinomas.~      ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and~     tyrosine kinase from working. These enzymes are needed for cells to divide including cancer~     cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide~     the tumor with nutrients for it to grow. It is believed that by blocking Aurora A and~     tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors~     may stop growing or shrink.~   "
87327|NCT01914484|"~     This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the~     treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute~     lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor~     therapies with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase~     inhibitor blocking alternative pathway independent of BCR-ABL mediated pathway, thus having~     a potential to overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or~     ALL patients. Phase I study will be conducted to define a recommended phase II dose (RPTD)~     and phase II study will examine the hypothesis that combinational approach will increase~     response rate of resistant CML/ALL patients, thus evaluating efficacy of the combination~     regimen.~   "
87328|NCT01914471|"~     Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and~     eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide~     environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and~     peer-led education and marketing.~      Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD)~     and assigned five to the intervention group and five to a wait-list control group. School~     records were obtained for number of fruits and vegetables served, students served lunch, and~     snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial~     variables among 2,997 seventh-graders (75% of all seventh-graders across schools).~      Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the~     proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy~     foods); increased fruit and vegetable servings (because SNaX increases access to~     sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater~     water consumption. We also hypothesized that SNaX would lead to more positive attitudes~     about the cafeteria and water, improve obesity-prevention knowledge, and increase intentions~     to drink water.~   "
87329|NCT01914458|"~     Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The~     application of low dose helical computed tomography (CT) has been the milestone of lung~     cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with~     low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to~     determine the efficacy of low dose CT in early lung cancer screening in Taiwan.~   "
87330|NCT01914445|"~     The purpose of this study is to examine whether oral administration of Indigo Carmine~     together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used~     instead of staining during the examination itself.~   "
87331|NCT01914432|"~     To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies~     in patients with hypertension and hyperlipidemia~   "
87332|NCT01914419|"~     The study will evaluate whether prophylactic oxytocin administered in the third stage of~     labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage~     compared to intramuscular (IM) injection.~   "
87333|NCT01914406|"~     The aim of this study was to examine the effects of high intensity aerobic interval training~     (AIT) versus moderate continuous training (CON) in heart transplant recipients.~   "
87334|NCT01914393|"~     This is an open-label, 104-week, multicenter, extension study designed to evaluate the~     long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or~     80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the~     preceding studies, D1050301, D1050325, and D1050326~   "
87335|NCT01914380|"~     The study aims to investigate the effectiveness of Eylea in patients with wet age-related~     macular degeneration in routine clinical practice in Germany. The study is purely~     observational, only data from routine treatment are to be collected. The treatment and~     treatment conditions are solely at discretion of the treating physician.~   "
87337|NCT01914354|"~     This is an observational multi-center study to determine whether any single immune~     monitoring test or a combination of tests obtained in the first 6 months after renal~     transplantation correlates with acute rejection or graft loss in renal allograft recipients~     receiving commonly used immunosuppressive.~   "
87340|NCT01914315|"~     The purpose of this prospective study is to determine whether comprehensive cardiac~     rehabilitation is superior to usual disease management in the treatment of patients with~     heart failure with preserved systolic function (HFpEF) recently discharged after an acute~     heart failure event.~      The investigators hypothesize that the addition of bi-weekly structured exercise training~     and interaction with medical personnel will lead to a greater reduction in all cause~     hospitalization and mortality while providing additional functional and clinical benefits~     such as exercise capacity, quality of life and well-being.~      Furthermore the investigators seek to establish clinical, laboratory and echocardiographic~     predictors of hospital readmissions and cardiovascular events in the predefined HFpEF~     population.~   "
87341|NCT01914302|"~     Characterize expressed blood volume ≥1μL across representative, commercially available~     lancing device systems using finger sticks.~   "
87342|NCT01914289|"~     The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma~     (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.~   "
87343|NCT01914276|"~     Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging~     surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging~     surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life~     in women with endometrial cancer who undergo staging surgery.~      Data analysis and risk/safety issues: The proposed study will consist of a convenience~     sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year~     period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and~     difference with its 95% exact confidence intervals between pre-and post-operative lower~     extremity lymphedema measurements and quality of life questionnaires will be estimated.~   "
87344|NCT01914263|"~     Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T~     lymphocytes which present a mixed T-NK phenotype and are endowed with a major~     histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good~     therapy for patients with solid tumor.However, tumor relapse is still a risk for those~     patients. Our hypothsis is that cytokine induced killer cells maybe decrease the recurrence~     rate. The purpose of this study is to evaluate the safety and tolerability of cord~     blood-derived cytokine induced killer cells in patients with solid tumor following radical~     resection.~   "
87345|NCT01914250|"~     The present study sought to examine the efficacy of two oral anesthetic drugs in reducing~     the pain associated with neonatal frenotomy.~   "
87346|NCT01914237|"~     Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic~     arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of~     Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.~      Number of patients: 70 patients will be included and undertaken endovascular repair with~     Castor stent.~      Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after~     the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery~      Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.~      Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.~      Other Outcome Measures:~        1. efficacy:~             -  1 year success rate of treatment~             -  1 year patency rate of branch stent~        2. safety:~             -  in-hospital mortality~             -  complication rate of neural system~             -  1 year dissection or stent related mortality~   "
87347|NCT01914224|"~     Reduction in sodium consumption is important approach in public health care. In general~     population, reduction of sodium intake can reduce the future development of hypertension and~     cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to~     reduce blood pressure and cardiovascular events. We hypothesized that combined education of~     low sodium and high potassium consumption is more effective in reducing blood pressure~     compared to dietary education of low sodium consumption only.~      The present survey study was designed to test the effectiveness of combined education of low~     sodium and high potassium consumption in blood pressure reduction and improvement of other~     variables.~   "
87348|NCT01914211|"~     This is an observational, prospective study to evaluate the role of tranexamic acid in~     reducing blood transfusion in neonates undergoing cardiopulmonary bypass.~   "
87349|NCT01914198|"~     The investigators are proposing a study where the investigators would give a survey to the~     parents of patients having a sleep study. The survey would contain questions relating to~     symptoms of sleep apnea and then the investigators would correlate the parent answers to the~     results of the sleep study.~   "
87350|NCT01914185|"~     The objectives were to 1) make students eat healthier and be more active; and 2) prevent~     overweight and obesity. Children will therefore be less likely overweight or obese.~     Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in~     Schools (APPLE Schools) was implemented in 10 schools throughout the Canadian Province,~     Alberta. Full-time School Health Facilitators were placed in each of the schools to~     implement what is know in Canada as Comprehensive School Health (CSH). In the United States,~     CSH is more commonly referred to as Coordinated School Health, while the synonymous term~     Health Promoting Schools is often used in Australia and Europe. The project was evaluated~     annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of~     time-stamped pedometers. The comparison group included approximately 150 schools that were~     randomly selected to reflect the population of Alberta, Canada. Twenty of these randomly~     selected schools also participated in data collection which involved the use of time-stamped~     pedometers.~   "
87351|NCT01914172|"~     Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a~     rare endocrine disorder that is characterized by failure to undergo puberty combined with~     infertility. KS/CHH patients face a number of psychosocial burdens related to delays in~     diagnosis, inadequate access to expert care, and lack of information about the condition. As~     such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This~     study aims to identify the needs of patients and understand the issues that must be overcome~     to achieve improved health and quality of life.~   "
87352|NCT01914159|"~     The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration~     (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical~     trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab~     (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study~     period of 12 months in 30 patients.~   "
87353|NCT01914146|"~     In the proposed study, the investigators examine in older adults with Type 2 diabetes the~     impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the~     response of arterial blood pressure and Doppler measures of cerebral blood flow during~     upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the~     cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not~     present at baseline.~   "
87354|NCT01914133|"~     The current proposal will determine if blocking carbohydrate intake in the small intestine~     with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial~     Hypotension (a drop of blood pressure after eating), which can result in falls.~   "
87355|NCT01914120|"~     The goal of this study is assess the quality of life of advanced non-small cell lung cancer~     (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and~     tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer~     Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st~     cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all~     the subscales and constructs of FACT-L. The assumption is the quality of life will be better~     after 2 cycle of chemotherapy.~   "
87356|NCT01914107|"~     This study aim at the advanced malignant tumor patients who suffer from cancer pain,~     investigate the current status of cancer pain treatment, and study the effects in pain~     control and quality of life improvement using the method of real-time monitoring and~     treatment instruction of cancer pain. This study is a randomized, controlled, single center~     clinical study. After recruitment, the subjects will randomly assign to standard cancer pain~     treatment group and standard cancer pain treatment plus real-time dynamic monitoring and~     treatment intervention of cancer pain using the cloud computing concept system. And then,~     assess the alleviation of cancer pain and quality of live. The assumption is the system will~     alleviate the cancer pain efficiently.~   "
87357|NCT01914094|"~     Low levels of physical fitness increase the risk of death in patients with cardiovascular~     disease. Although cardiac rehabilitation programs improve the health of patients after heart~     surgery, most patients are not referred until after surgery. Therefore, the purpose of this~     study was to determine if an exercise pre-habilitation (i.e., Prehab) program before heart~     surgery would improve the health of patients before surgery and whether these improvements~     would be maintained after surgery.~      The investigators hypothesized that Prehab would promote the health of patients before heart~     surgery, and these improvements would be maintained three months post-operatively, as~     compared to patients who received standard care.~   "
87358|NCT01914081|"~     The purpose of this study is to determine if resveratrol can improve heart function and~     quality of life. Although, population studies have revealed that a mild to moderate intake~     of red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate~     the potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy~     have not been previously reported. Accordingly, this research is being done because it will~     fill this deficiency in the information available in the literature and establish the~     clinical benefits of resveratrol in patients with this type of heart disease.~   "
87359|NCT01914068|"~     Patients' ability to tolerate surgery is associated with physical fitness: less fit patients~     have an increased rate of death and serious complications following major surgery. Combined~     chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as~     neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but~     adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data~     showing that NACRT reduces objectively measured physical fitness (measured by~     cardiopulmonary exercise testing) in patients having surgery. This pre-pilot study~     investigated the effects of a 6-week structured responsive endurance training programme~     (SRETP) after NACRT and before cancer surgery. This programme has improved both their~     fitness and their health related quality of life(HRQL). Now, the investigators are~     undertaking a randomised controlled trial to compare changes in patient's physical fitness~     in response to SRETP with a group of patients who will be given exercise advice. The SRETP~     group will exercise 3 times a week for 9 weeks. The investigators will make objective~     measurements of physical fitness in both groups. The investigators will monitor patient's~     perceptions of the training programme, HRQL, daily activity (using an accelerometer), and~     outcomes after surgery. The investigators believe that, patients in the exercise group will~     improve their physical fitness prior to surgery, change behaviour towards exercise, improve~     activity and HRQL following NACRT. These results will contribute to the design of a large,~     multi-centre trial to determine whether a SRETP increases physical fitness with a reduction~     in adverse outcome following surgery. The investigators will conduct an adequately powered~     randomized controlled trial (RCT) comparing a SRETP with 'exercise advice' in 46 rectal~     cancer patients. Specifically, we will test the following hypotheses and outcomes: PRIMARY~     HYPOTHESIS A 9-week, structured responsive endurance training programme (SRETP) compared~     with a control group (no training) will result in a clinically significant difference in~     physical fitness (2.0ml/kg/min VO2 at LT) post-NACRT prior to surgery.~      SECONDARY OUTCOMES~        1. A 9-week SRETP compared with a control group (no training) will result in a clinically~          significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have~          had NACRT prior to surgery.~        2. SRETP following NACRT and prior to cancer surgery will provide psychological health~          benefits and improve patient's HRQL (assessed by semi-structured interviews and~          questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory~          information that will inform a future application to deliver a larger appropriately~          powered RCT exploring the hypothesis that patients with greater pre-operative fitness~          will encounter lower postoperative morbidity and mortality. Specifically, these~          exploratory outcomes are:~      EXPLORATORY OUTCOMES~        1. To investigate whether SRETP following NACRT and prior to surgery is associated with a~          change in overall physical activity (assessed by the number of steps while active using~          an accelerometer).~        2. To investigate whether there is a change in the day 7 surgical morbidity (using the~          Post-Operative Morbidity Survey) and mortality.~        3. The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis~          Staging-TNM staging).~   "
87360|NCT01914055|"~     demonstrate that FD-OCT guidance is feasible and possibly results in reduction of~     frequency-domain Optical Coherence Tomography-defined residual thrombus burden after~     thrombus-aspiration.~   "
87361|NCT01914042|"~     Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid~     treatment in patients with chronic neuropathic pain.~   "
87362|NCT01914029|"~     The purpose of the study is to add to the knowledge of mechanisms of immune health.~     Parameters of the immune system will be followed over time in volunteers allergic to dust~     mites and bee sting after receiving immunization therapy. This information will be compared~     to healthy volunteers without allergy. We aim to bring new understanding of immune processes~     by this comparison.~   "
87418|NCT01913119|"~     Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and~     poor prognosis. Currently, there is no treatment option for relapsed or refractory~     extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was~     approved for cutaneous T-cell lymphoma. A recent phase II study of romidepsin for~     relapsed/refractory peripheral T-cell lymphoma reported an overall response rate of 38% (95%~     confidence interval 24%-53%). The median duration of overall response was 8.9 months.~     Considering the median number of previous treatments in these patients was three (range~     1-11), romidepsin has single agent activity against relapsed/refractory T-cell lymphoma.~     Thus, if the single agent activity of romidepsin is demonstrated, it could be a therapeutic~     agent for combination with salvage treatment.~   "
87363|NCT01914016|"~     People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot~     is not adequately lifted during the so-called swing phase (foot is off the ground) during~     walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the~     shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls.~     There have been several studies showing the benefits of FES to the walking of pwMS. The~     proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in~     Edinburgh and the Lothians This will be achieved firstly through a survey to all clients~     with MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot~     study will assess the suitability of the use of simple clinical measurement~     (electrogoniometry) which will allow the measurement of the degree of foot-drop. The degree~     is foot drop is usually assessed by the physiotherapist using visual observation. Using a~     small device which can be quickly fitted to the patient's lower and foot for the duration of~     a 2-6 minute walk, the physiotherapist will be able to quantify the degree of foot drop over~     time. Such a measurement is especially important for people with MS who are often affected~     by increased mental and physical fatigue.~      Our first hypothesis is that the degree of foot-drop at the end of the walk is increased~     compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is~     less when the participant walks with the assistance of Functional Electrical Stimulation at~     their next clinical appointment.~   "
87364|NCT01914003|"~     Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which~     mutations in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting~     in diarrhea and abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain~     will have their sucrose-isomaltase gene assessed for a panel of known CSID mutations to~     determine the prevalence of these mutations in an enriched population and also determine~     functional deficiency using a breath test.~   "
87365|NCT01913990|"~     For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis~     (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and~     vomiting) control compared with standard anti-emetic regimen. The risk calculator has the~     potential to provide more individualized anti-emetic regimen by decreasing the use of~     toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing~     the appropriate anti-emetic regimen in patients at high risk.~   "
87366|NCT01913795|"~     The investigators aim to pilot the role of school based intervention consisting of enhanced~     integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.~   "
87367|NCT01913782|"~     Chronic low back pain (CLBP) is the most prevalent form of chronic pain, and the most common~     reason for disability in working-age population [2]. CLBP has also been reported associated~     with many abnormal brain anatomy and function which includes the reduction in cortical gray~     matter in the bilateral dorsolateral prefrontal cortex (DLPFC), thalamus, brain stem,~     primary somatosensory cortex, and posterior parietal cortex. [3-5] There are already many~     studies that demonstrated abnormal cortical function for people with CLBP [6-10]. Meanwhile,~     DLPFC was also reported to be influenced by many pain process which included pain modulation~     [11-13], placebo analgesia [14, 15], pain control [16, 17]or pain catastrophizing[18]. And~     recent report has showed that effective treatment of chronic back pain patients reverses~     abnormal DLPFC function[19]. Meanwhile, epidural steroid injection has been performed in~     clinical for routinely managed for low back pain patients. Patients refused or have no~     indication for surgery or have little response to rehabilitation may consider this~     management. There was good evidence for short- and long-term relief of chronic pain~     secondary to disc herniation with local anesthetic and steroids[20, 21]. However, the impact~     of this treatment on functionalMRI (fMRI) has never been investigated. The investigators~     research will try to solve this issue.~      This study will provide a good relationship for the pain fMRI image in brain after local~     lumbar spine management. And the investigators also want to perform the first data that~     showed local lumbar analgesia have the impact on brain image change.~   "
87368|NCT01913769|"~     Background:~      Chemoradiation is an important treatment strategy of locally advanced inoperable or~     unresectable disease. Radiation dose is an independent predictor of a pathological response.~     In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local~     treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There~     have been sequential improvements in tumor localization, radiation planning and delivery~     over the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy~     (RT) dose delivered to thoracic malignancies, and allows greater sparing of the heart from~     doses associated with increased complications. However, heart disease shows a wide spectrum~     of pathologies, and multiple risk factors related. The damage of the myocytes may lead to~     not only myocardial perfusion defects, but also in functional deterioration, or even in~     biomarkers.~      Since the impact of radiation-induced heart injury in patients with thoracic malignancies~     (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate~     of RT-related cardiac effects and clinical impacts.~      Objective:~      This study aims to investigate the correlation of post-tomotherapy cardiovascular effects~     with myocardial perfusion and cardiac functional studies.~      Methods:~      The study plans to enroll thoracic cancer patients who will undergo local RT after complete~     staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS),~     blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion~     image (MPI) at the time points of before and after RT. The results of MPI will be analyzed~     in qualitative visual interpretation of perfusion patterns, and functional quantitative data~     for cardiac functional parameters as well. The patients will be regular followed-up in CV~     OPD, following clinical judgement and guideline. The association between baseline and~     follow-up MPI, biomarker and clinical presentation will be further investigated.~      Expected results:~      We will obtain myocardial perfusion visual qualitative data in patients who received~     locoregional RT, respectively. These results will help in the understanding of~     pathophysiology, clinical management and follow-up of suspected RT-related heart disease.~   "
87377|NCT01913652|"~     Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50~     histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct~     genetic, pathological and clinical profiles, and varying patterns of tumor spread. The~     optimal cytotoxic treatment for this group of patients remains uncertain. Single agents~     which are most effective include doxorubicin and ifosfamide, but objective response rates~     and progression-free survival times remain modest. There is clearly a need to improve~     treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the~     protein tubulin in cells, interfering with cancer cell division and growth , has~     demonstrated activity in STS. Therefore, it is reasonable to explore whether other~     anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be~     a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate~     cancer. The main objective of this trial is to determine whether cabazitaxel or prolonged~     infusional ifosfamide demonstrate sufficient antitumor activity for liposarcoma.~   "
87369|NCT01913756|"~     The purpose of this trial is to investigate the effect of dairy products on the so called~     metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood~     pressure and high cholesterol, for the development of diabetes and heart disease.~     Participants will be randomly assigned to either eat a portion of a Norwegian traditional~     cheese which is high in protein and low in fat (group 1), or eat a slightly higher than~     normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese~     (group 3).~      Dairy products are a significant source of bioactive peptides, small pieces of protein which~     may have an effect on our health. These effects may be antimicrobial, antioxidative, or~     blood pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high~     in protein (50%) and low in fat (<1%), has been found to be particularly high in these~     bioactive peptides. Specifically, the cheese was found to have a very high ACE-inhibitory~     activity, meaning it has the potential to lower blood pressure without the use of~     pharmaceuticals.~      A pilot study was performed in May 2012. No intervention was given in this trial, but~     participants answered an extensive questionnaire about dietary habits and lifestyle. This~     trial found that the people who ate the most Gamalost had a slightly lower blood pressure~     than those that did not eat the cheese. Since that was just a point-in-time study with no~     intervention or control, the investigators are not able to say anything certain about cause~     and effect, which is why the investigators want to perform this larger controlled study.~      In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100~     in each group. The participants will be randomly placed in one of the groups and they will~     have to do the intervention for eight weeks. At inclusion, the investigators measure blood~     pressure, fasting blood glucose, weight, height, waist circumference, and the investigators~     draw a fasting blood sample to measure cholesterol. The same measurements will be repeated~     at the end of the eight weeks. At inclusion they will also fill out an extensive~     questionnaire about their diet and lifestyle. A shorter version of the same questionnaire~     will also be given at the end of the trial period.~      The overall goal of the study is to assess the effect of dairy products on the metabolic~     syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce~     blood pressure in a group of people.~   "
87370|NCT01913743|"~     Previous studies have shown that obese individuals exhibit greater reward-related brain~     activity in response to food cues than lean individuals and our group has shown that~     successful weight loss maintainers who were previously obese and now maintain a healthy~     weight have increased control-related activity when viewing food cues. These findings~     suggest key roles for both reward-related brain areas and inhibitory control regions in~     eating behavior. However, no studies to date have examined (a) whether the response to food~     cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are~     most effective at altering brain response to food cues, or (c) the neural mechanisms that~     support such change.~      Given the omnipresent environmental cues to eat and the association between heightened~     reward-responsivity and obesity, it is critical to investigate ways to potentially alter~     food cue-reactivity in the obese. The most widely employed approach for behavioral weight~     loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to~     control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on~     something else). This approach is sometimes described as change- focused because modifying~     negative thoughts is assumed to thereby change associated maladaptive emotions and~     behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy~     (ACT), which teaches participants to recognize and accept their cravings as feelings that~     need not be acted upon, may also be effective in treating obesity. A third strategy often~     employed in smoking cessation and substance abuse treatment is to focus on the long-term~     consequences of behaviors, however this form of treatment is not typically used in~     behavioral weight loss therapy. Thus although each approach is potentially effective, these~     treatment approaches differ greatly in the cognitive strategies they employ.~      The primary aim of the proposed research is to compare a cognitive strategy used in CBT~     (ʻCHANGEʼ), a cognitive strategy emphasized in ACT (ʻACCEPTʼ), and a cognitive strategy used~     in smoking cessation (ʻLATERʼ) relative to a control condition (ʻNOWʼ), in their~     effectiveness in altering reward and inhibitory control responses to food cues among obese~     individuals.~   "
87371|NCT01913730|"~     This is a multicenter, randomized, open label study designed to evaluate the efficacy and~     safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a~     salvage treatment containing bortezomib for relapsed or refractory multiple myeloma~     patients.~   "
87372|NCT01913717|"~     The present research project aims to improve the current treatment for prostate-confined~     tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy~     schedule administered with one of the best available dose delivery systems. The study will~     include 2 sub-studies (in-silica and clinical study) and 4 tasks.~   "
87373|NCT01913704|"~     The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen~     device versus a placebo in patients with non-healing leg ulceration in conjunction with~     standard best practice.~   "
87374|NCT01913691|"~     Background:~      - Ipilimumab is a drug used to treat melanoma that cannot be treated surgically. It targets~     a molecule found on T-cells in the human immune system. Blocking these molecules on the~     T-cells might allow the cells to help destroy melanoma cells more effectively. This drug has~     also been studied in other cancers such as prostate cancer and lung cancer, but not yet in~     Merkel cell carcinoma (MCC). Researchers think therapy like ipilimumab that enhances the~     immune system may be effective against MCC. They want to study how safe the drug is and its~     effect on the immune system and tumors.~      Objectives:~      - To determine the number of subjects with MCC who take the study drug that remain alive 12~     months later.~      Eligibility:~      - Adults 18 years and older who have metastatic MCC.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will receive the study drug 4 times, one dose every 21 days. After the 4~          visits, participants will receive a maintenance dose of the drug every 12 weeks until~          the drug is no longer beneficial.~        -  They will receive the drug through a plastic tube usually inserted in a vein on the~          arm.~        -  It will take 90 minutes to give each dose.~        -  At all visits, participants will be screened with a medical history, physical exam, and~          blood tests. Any tumors on their skin will be measured and photographed.~        -  Every 12 weeks during the study and maintenance period, participants will have a CT~          scan. Throughout the study and maintenance period, they will have blood and skin tests.~   "
87375|NCT01913678|"~     The objective of this study is to investigate whether intake of a diet with a high content~     of butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet.~     Further to examine whether high intake of inulin (a prebiotic) can increase the proportion~     of butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In~     addition, the correlation between FIAF blood concentrations and resting energy expenditure,~     blood lipid profile and gut microbiota composition will be investigated.~      Furthermore, this study will investigate whether the source of FIAF can be determined. To~     this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal~     water samples will be carried out.~      The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration~     of 3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to~     the order of interventions. Before and after each intervention period, blood samples will be~     collected and the participants will have their resting metabolic rate measured. At the end~     of each intervention period, the participants will collect feces for 5 consecutive days. In~     addition, adipose tissue biopsies will be taken after each intervention period.~   "
87376|NCT01913665|"~     The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on~     functional constipation in children~   "
87378|NCT01913639|"~     The purpose of this study is to evaluate the effects, good and/or bad, of the drug~     regorafenib with chemotherapy regime (FOLFOX). This is a a Phase II trial that will study if~     this new treatment is effective and safe in patients with esophagus and stomach cancer.~   "
87384|NCT01913561|"~     The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable~     12/15-lead ECG.~      The electrodes are dry, textile ECG electrodes. The garment is designed to position the~     electrodes in the appropriate anatomical locations, without any special guidance. The dry~     electrodes are made from unique yarns with silver embedded into the garment using a~     proprietary technique developed by HealthWatch (HW)that obviates the need for skin~     preparation or the application of fluids. The garment can be connected to any standard ECG~     device available in the hospitals.~      The purpose of this study is to evaluate the safety and effectiveness of the Master Caution~     Garment for continuous monitoring of ECG signal compared to standard gel electrodes.~      The following endpoints will be evaluated in subjects participating in the study:~      Primary:~      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes~     using standard ECG devices.~      Secondary:~      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes~     when event is detected by the ECG devices.~   "
87385|NCT01913548|"~     The purpose of this study is to demonstrate that a sufficient number of iron-overloaded~     thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations~     with similar duration of chronic transfusion, and age at start of transfusions would be~     available for a confirmatory study. The study will examine the hypothesis that a chronic~     inflammatory state in SCD leads to hepcidin- and cytokine-mediated iron withholding within~     the RES (reticuloendothelial system), lower plasma NTBI (non-transferrin bound iron) levels,~     less distribution of iron to the heart in SCD.~   "
87386|NCT01913535|"~     This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of~     oral CERC-501 for treating patients with treatment resistant depression who are taking an~     antidepressant that is not working for them.~   "
87387|NCT01913522|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated~     with reductions in quality of life, functional status, cardiac performance, and overall~     survival.1 Catheter ablation, which is centered on electrical isolation of triggering foci~     within the pulmonary veins (PVI) through circumferential lesions around PV ostia, has been~     shown to result in sustained improvements in quality of life, decreased hospitalizations~     and, potentially, improved survival.2-4 PVI can be accomplished by percutaneous~     catheter-based thermo-coagulation (burning) with radiofrequency (RF) energy delivery or~     alternatively by thermo-cooling (freezing) with a cryoballoon catheter.5 Cryothermal~     ablation with a cryoballoon catheter offers an efficacious means to achieve PVI that is~     safer than the established technique. Although cryoballoon ablation has been used in~     clinical practice for sometime, the optimal duration of cryoballoon ablation has not been~     determined. Moreover, the biophysics of cryo-lesion formation suggests that repeated short~     freezes (freeze-thaw-freeze cycles) may be more efficacious in achieving deep homogenous~     lesion when compared to prolonged freezing durations. This grant proposal is to verify if~     repeated short freezing cycles are more efficacious (i.e., fewer recurrence of AF), and~     safer, than the established standard of long, single freeze cycles.~   "
87388|NCT01913509|"~     The investigators anticipate this research will shed light on metric properties of outcome~     measures of pain and fatigue and the effects of the combined therapy for stroke patients.~     The overall findings will contribute to guide the choice of proper assessment tool and the~     development of effective rehabilitation programs.~   "
87389|NCT01913496|"~     The study is planned for people who would like to reduce or maintain their weight and keep a~     healthy life style .After signing an informed consent, participants will be divided randomly~     into two groups :control group and an intervention group that will get the application~     (eBalance ). Participants will be followed for 12 weeks.~   "
87390|NCT01913483|"~     The primary objective of the study is to demonstrate that anticoagulation with bivalirudin~     results in fewer major bleeding complications compared with unfractionated heparin (UFH) in~     subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is~     to identify potential benefits from bivalirudin therapy on other clinically important events~     such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA),~     amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as~     potential economic benefits that may result from improved clinical outcomes.~   "
87391|NCT01913470|"~     Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children~     and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of~     mortality and natural history studies of adults show that NAFLD is an independent risk~     factor for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public~     health standpoint, as it represents an early and possibly more aggressive form of the~     disease. Currently there is no effective treatment for pediatric NAFLD.~      Losartan is an orally-administered angiotensin II receptor antagonist which is currently on~     the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has~     been shown to be important in many disease states including renal disease, cardiovascular~     disease, and NAFLD. Angiotensin antagonists are a class of medications that has been~     proposed as a novel treatment of NAFLD in part because they would treat both the factors~     increasing cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and~     hepatic inflammation.~      This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate~     whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19~     with a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine~     aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate~     aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others.~     Safety will be assessed by the recording of adverse events, clinical laboratory parameters,~     vital signs and physical examinations.~   "
87419|NCT01913106|"~     The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical~     studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with~     brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach~     to prostate cancer and hopefully impact on the development of metastatic disease and the~     control of preexisting metastasis.~   "
87498|NCT01912066|"~     This is a phase IV clinical study to evaluate the preventive effectiveness of~     NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind,~     active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug~     of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects~     for four weeks.~   "
87392|NCT01913457|"~     Recently it has been shown that clear reproducible Doppler signals can be recorded from the~     lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special~     signal processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These~     lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained~     from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS~     waves typically have peak velocities of up to 30 cm/s and are of relatively high power,~     making it possible to detect them despite the aforementioned attenuation by the air in the~     lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood~     vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the~     lung vasculature. The LDS may contain information of significant diagnostic and~     physiological value regarding the pulmonary parenchyma and vasculature, as well as the~     cardio-vascular system in general.~      Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small~     pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to~     right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically~     undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary~     artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the~     expertise of the individual carrying out the test. Therefore, the pulmonary arterial~     pressure and cardiac output values have to be ascertained with a right-sided cardiac~     catheterization, which is considered the gold-standard, but is invasive.~      In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown~     to have the potential to diagnose pulmonary hypertension in two different ways: First, by~     measuring the degree of attenuation of the LDS during acute pressure rise in the chest~     cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in~     patients with PAH and control subjects.~      One of the objectives of the present study is to evaluate the lung Doppler signals in~     pediatric patients of various age groups, with and without pulmonary vascular disease. The~     second objective of the study is to verify previous findings of abnormal lung Doppler~     signals in adult patients with pulmonary hypertension.~   "
87393|NCT01913444|"~     Maintenance of adequate anticoagulation or blood thinning is of critical importance when~     patients are placed on extracorporeal life support, such as extracorporeal membrane~     oxygenation (ECMO). During ECMO, a patient's entire blood volume is constantly exposed to~     the artificial surfaces of the ECMO circuit. This exposure activates the clotting cascade,~     and not only is the circuit at risk for clot formation, but the patient is also at risk for~     clotting within the body. Hence anticoagulation is vital in allowing the ECMO circuit to~     support a patient for an extended period of time. Anticoagulation on ECMO is achieved~     primarily by the use of a blood thinning agent called heparin. Heparin's main mechanism of~     action is to activate an enzyme called antithrombin III (AT III). AT III deficiency has been~     shown to be a common finding in pediatric patients requiring ECMO. This deficiency may then~     result in ineffective blood thinning by heparin. The purpose of this study is to determine~     how a neonate on ECMO, processes and eliminates a medication called ATryn® from their body.~     ATryn® is a form ATIII that is made from goat's milk. This will ultimately aid in~     establishing standardized dosing for the use of ATryn® in this patient population.~   "
87394|NCT01913431|"~     This is a multicenter, double blind, active-controlled, randomized, parallel group study to~     demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for~     patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48~     days.~   "
87395|NCT01913418|"~     The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving~     sleep quality, anxiety, depression, and heroin craving among methadone-maintained persons~     with sleep complaints.~   "
87396|NCT01913405|"~     The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe~     hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing~     elective surgical or other invasive procedures.~   "
87397|NCT01913392|"~     A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in~     the potential renal transplant candidate who is denied acceptance due mainly to the morbid~     obesity.~   "
87398|NCT01913379|"~     A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and~     MDV3100 and Itraconazole.~   "
87399|NCT01913366|"~     Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the~     University of California, San Francisco is conducting a study comparing two types of~     interventions for treating depression in rural older adults.~   "
87400|NCT01913353|"~     To demonstrate the efficacy of MVA-BN® by showing that vaccination prior to administration~     of ACAM2000® results in an attenuated take.~   "
87401|NCT01913340|"~     Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a~     baby's brain near the time of birth, may cause death or neurologic disability. Cooling~     therapy (hypothermia) provides some protection, but about half of affected infants still~     have a poor outcome. This clinical trial will determine if the drug erythropoietin, given~     with hypothermia, is safe to use as a treatment that may further reduce the risk of~     neurologic deficits after HIE.~   "
87402|NCT01913327|"~     The purpose of the study is to determine whether two commonly-prescribed antipsychotic~     medications (aripiprazole and risperidone) have different effects on brain function and~     cognition in schizophrenia patients.~   "
87403|NCT01913314|"~     This type of study is called a radiolabeled study. For this study, LY2835219 (study drug)~     has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally~     occurring radioactive form of the element carbon. This study will help understand how the~     drug appears in the blood, urine, and stool after it is administered.~      In addition, this study will also evaluate the safety and tolerability of a single dose of~     LY2835219 when given to healthy participants. Information about any side effects that may~     occur will also be collected.~      This study will last about 3 weeks for each participant, not including screening.~   "
87404|NCT01913301|"~     The purpose of the study is to gather information regarding the safety and effectiveness of~     an investigational drug called Alagebrium when used treating Heart Failure in relation to~     exercise tolerance after 6 months in the trial.~   "
87405|NCT01913288|"~     The purpose of this RCT is to learn more about how sounds that we experience in the womb can~     affect early development in premature infants. The investigators are specifically interested~     determining whether and what types of maternal sensory stimulation can influence physical~     growth, brain maturation, respiratory stability and early vocalization during postnatal~     development. The investigators hypothesize that daily exposure to biological maternal~     sounds, such as mother's voice and heartbeat, will improve both short-term and long-term~     developmental in premature infants and will increase their potential to grow into healthy~     children.~   "
87499|NCT01912053|"~     The purpose of this study is to assess efficacy and tolerance of intra-hepatic~     administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association~     with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of~     intra-hepatic cholangiocarcinoma.~   "
87406|NCT01913275|"~     Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at~     the lower end of the common bile duct. Whenever possible, surgical resection in the form of~     Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is~     associated with a substantial postoperative morbidity and mortality. With advances in~     surgical techniques and postoperative care there has been a decrease in the operative~     mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the~     various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has~     been associated with an increased risk of complications. Preoperative biliary drainage has~     been tried to decrease the serum bilirubin levels and consequently decrease postoperative~     morbidity and mortality. Internal biliary drainage can be achieved by surgical~     cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a~     day care procedure under conscious sedation, but involves insertion of a foreign body~     (stent), which results in introduction of bacteria into the bile and problems of~     postoperative infection. Also, endoscopic stenting before surgery may result in difficulty~     in dissecting around the common bile duct during the surgical procedure. While the surgical~     bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree~     and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical~     incision.~      There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in~     patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative~     endoscopic biliary drainage with surgical drainage in patients undergoing~     pancreaticoduodenectomy.~   "
87407|NCT01913262|"~     This is an observational registry intended to track depression scores of patients over time~     in treatment.~   "
87408|NCT01913249|"~     The aim of this study is to compare short term (3 week) with long term (6 months) treatment~     with seton prior to LIFT surgery. The main end-points are recurrence rates and complication~     rates after surgery.~   "
87409|NCT01913236|"~     Background The prevalence of depression is high and the elderly have an increased risk of~     developing a chronic course. International data suggest that depression in the elderly is~     under-recognised, the latency before clinicians provide a treatment plan is longer, and~     elderly patients with depression are not offered psychotherapy to the same degree as younger~     patients. Although recommendations for the treatment of elderly patients with depression~     exist, health care professionals adhere to these recommendations to a limited degree only.~     Investigators conducted a systematic review to identify recommendations for managing~     depression in the elderly and prioritised six recommendations. Investigators identified and~     prioritised determinants of practice related to implementation of these recommendations in~     primary care, and subsequently discussed and prioritised interventions to address the~     identified determinants. The objective of this study is to evaluate the effectiveness of~     these tailored implementation interventions to implement six recommendations for the~     management of elderly patients with depression in primary care.~      Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing~     implementation of the six recommendations using tailored interventions with usual care.~     Investigators will randomize 80 municipalities into one of two groups: an intervention~     group, to which investigators will deliver tailored interventions to implement the six~     recommendations, and a control group, to which investigators will not deliver any~     intervention. Investigators will randomise municipalities rather than patients, individual~     clinicians or practices because we will deliver the intervention for the first three~     recommendations at the municipal level and investigators want to minimise the risk of~     contamination across practices for the other three recommendations. The primary outcome is~     the proportion of general practitioners' behaviours which are consistent with the~     recommendations.~      Discussion This trial will investigate whether a tailored implementation approach is an~     effective strategy to improve collaborative care in the municipalities and health care~     professionals' practice towards elderly patients with depression in primary care. The~     effectiveness evaluation described in this protocol will be accompanied with a process~     evaluation exploring why and how the interventions were effective or ineffective.~   "
87410|NCT01913223|"~     ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial~     neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of~     the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2)~     circumferential (complete or partial) incision and 3) dissection of the submucosa. Several~     tools are necessary to perform ESD with the standard technique. Development of water jet~     with bi functional (injection and cutting) catheter allows time and significant reduction of~     perforation risk (due to multiple changes of instruments). For this purpose, Nestis~     introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently~     and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig~     studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2~     are possible. In addition, preclinical studies on living pig colon models using saline~     solutions have demonstrated that perforation rates and operating times are significantly~     reduced compared to a standard electrosurgical knife. The present clinical study is being~     performed to confirm this system capability to perform ESD in humans.~   "
87411|NCT01913210|"~     To determine the effect of ginseng on blood pressure control.~   "
87412|NCT01913197|"~     In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate~     to treat the entire gland. This is done because, in the past, it was impossible to know~     where the cancer was located within the prostate. Multiparametric magnetic resonance imaging~     (MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether~     using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing~     lower doses to be delivered to the regions of the prostate without tumor while~     simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then~     be followed over two years and evaluated for toxicity. In addition, after two years they~     will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.~   "
87413|NCT01913184|"~     To compare the continuous and sicontinuous delivery of drug with AKITA.~   "
87414|NCT01913171|"~     o determine effects of hula-hooping on android obesity, metabolic parameters and adipose~     tissue (AT) gene expression.~   "
87415|NCT01913158|"~     The primary objective of this study is to determine the safety and efficacy of G&W~     Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects~     with internal hemorrhoidal symptoms.~   "
87416|NCT01913145|"~     This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger~     Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood~     taken from the arm vein).~   "
87417|NCT01913132|"~     The wound infection rate in the groin after vascular surgery has been denoted to be high~     since the wound surveillance register started in 2005. The current wound infection rate~     based on a validation study was 22.9% (24/105 patients with groin incision(s) between 1~     March to 30 June in 2012). The Deep/superficial infection ratio was 7/17. To prove that PICO~     (negative wound pressure therapy) reduces the wound infection rate with ½ standard~     deviation, 90% power at the 5% significance level, inclusion of 160 patients, 80 patients in~     the PICO Group and the standard dressing group are needed.~   "
87500|NCT01912040|"~     Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice~     to help in patient management decisions.~   "
87420|NCT01913093|"~     To find possible therapeutic targets to help prevent long-term brain and behavioural side~     effects in survivors of childhood leukemia that may have been caused by chemotherapy~     (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is~     that genetic variations of the elements in the folate-related cycles and methotrexate~     disposition networks are associated with the TRANCE phenotype of childhood leukemia~     survivors.~   "
87421|NCT01913080|"~     The goal of the present study is to determine if a health management tool improves~     self-efficacy, satisfaction with the doctor's visit, and agreement of the statement How~     satisfied are you that your concerns were addressed during your clinic visit today over~     time.~   "
87422|NCT01913067|"~     A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to~     breast and non-small-cell lung cancer (NSCLC).~      OBJECTIVES:~      Primary:~      The purpose of this study is to determine if cabazitaxel can induce a reduction in the size~     brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis~     who were not previously treated with whole brain irradiation or require immediate brain~     irradiation.~      Secondary:~        -  To determine the effect of cabazitaxel on the time to initiating whole brain~          irradiation or radiosurgery~        -  To determine the effect of cabazitaxel on the time to developing neurological symptoms~        -  To determine the effect of cabazitaxel on the time to disease progression in the brain~        -  To determine the effect of cabazitaxel on the time to disease progression outside the~          brain. This will be evaluated separately for the breast and NSCLC cohorts To determine~          the objective extra-cranial response (if applicable). This will be evaluated separately~          in the breast and NSCLC cohorts~        -  To determine the safety of cabazitaxel~   "
87423|NCT01913054|"~     Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very~     important role especially in early diagnosis and differential diagnosis of esophageal and~     gastric carcinoma. However, conventional gastroscopy is associated with several adverse~     effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and~     increased heart rate) due to which some patients are intolerant to this examination or even~     refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been~     applied increasingly widely in outpatients to meet the increasing needs for comfortable~     medical care.~      Painless gastroscopy is commonly performed under general anesthesia without establishing an~     artificial airway. This is associated with an even higher anesthetic risk than general~     anesthesia in the operating room due to more basic patient monitoring and life-supporting~     equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the~     requirement for a high turnover rate, as well as limited understanding of a patient's~     condition. Therefore, the availability of sedatives and analgesics which can provide rapid~     onset, sufficient sedation and analgesia, a short recovery time and less adverse effects are~     the premise of performing painless gastroscopy. Currently, combined intravenous anesthesia~     with fentanyl and propofol, commonly used in the clinic, is still associated with a long~     duration of action, hypotension in some patients and prolonged recovery. Etomidate has been~     increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless~     coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal~     impact on the circulatory and respiratory systems. However, no study on combined intravenous~     anesthesia with fentanyl and etomidate for painless gastroscopy had previously been~     reported. The main purpose of this study is to explore the efficacy and safety of combined~     intravenous anesthesia with fentanyl and etomidate for painless gastroscopy compared with~     the combination of fentanyl and propofol in middle aged and elderly patients, and to provide~     reliable evidence for the implementation and promotion of comfortable medical care.~   "
87424|NCT01913041|"~     -  The purpose of this study is to understand and grasp the incidence rate of hypothermia~          during perioperative period of elective operations under general anaesthesia in~          Beijing.~        -  The purpose of this study is to carry out a subgroup analysis on the survey data and~          explore the high-risk factors for the incidence of hypothermia.~   "
87425|NCT01913028|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     immunogenicity of MEDI9929 following administration of single ascending doses in healthy~     male Japanese subjects.~   "
87426|NCT01913015|"~     This randomized pilot phase I trial studies the side effects of dietary fat levels and~     abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer.~     Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone~     acetate.~   "
87427|NCT01913002|"~     This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000~     mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.~   "
87428|NCT01912989|"~     The purpose of this study is to investigate if a brief, motivational interviewing~     intervention (NOURISH+MI) can improve retention and treatment adherence for parents enrolled~     in an intervention for their child's overweight (NOURISH+). The investigators hypothesize~     that children whose parents participate in NOURISH+MI will demonstrate lower attrition and~     greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared~     with children whose parents are randomized to NOURISH+ or a control group.~   "
87429|NCT01912976|"~     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's~     disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment~     removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no~     studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in~     treating BD of the lower extremities in Asians.~   "
87440|NCT01912833|"~     The purpose of the funded study is to determine a) examine associations among OT levels,~     stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess~     whether there are differences between immigrant women and non-immigrant Latina women on~     these measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD~     and whether there are differences between immigrant and non-immigrant Latina women; and c)~     assess the feasibility of enrolling Latinas into a laboratory-based study that includes the~     collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal~     (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and~     45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to~     breastfeed for more than 2 months, who have or do not have a history of depression, and who~     are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas~     who report maternal or infant disorder that may interfere with breastfeeding; those who~     endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis~     or serious personality disorders) other than depression or anxiety will be excluded to~     minimize risk and confounds with the outcomes of interest.~   "
87515|NCT01911845|"~     The purpose of this study is to evaluate the safety and efficacy of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with~     ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or~     buprenorphine ± naloxone.~   "
87430|NCT01912963|"~     In this study, the investigators are testing the effectiveness of the combination of~     eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in~     treating advanced HER2-positive breast cancer that had received at least one prior treatment~     previously. At this point, the standard treatment for HER2-positive cancer that has~     progressed (grown) after a first treatment is chemotherapy combined with therapies that~     target the HER2 protein (e.g., trastuzumab or lapatinib).~      All of the medications that are being tested in this study are approved by the Food and Drug~     administration (FDA) for the treatment of metastatic breast cancer. However, the combination~     of these three medications in participants has not yet been tested. Eribulin is a~     chemotherapy agent that is approved for the treatment of metastatic breast cancer for women~     who have previously received at least two prior chemotherapeutic regimens for the treatment~     of their metastatic disease. Pertuzumab and trastuzumab are also both approved for the~     treatment of advanced HER2-positive breast cancer. Both agents help treat breast cancer by~     binding HER2 receptor. However, pertuzumab and trastuzumab bind to different parts of the~     HER2 receptor.~      The goal of this research study is to find out if adding pertuzumab, trastuzumab and~     eribulin is effective in treating women with metastatic, HER2-positive breast cancer. The~     Investigators, will also gather more information on the side effects of these treatments~      The investigators also plan to gather genetic information from participants' tumors~     (collected at biopsies). Cancers occur when the molecules that control normal cell growth~     (genes and proteins) are altered. Changes in the tumor genes and in the genes of normal~     cells are called alterations. Many of these alterations can be detected by directly~     examining cancer cells in a tumor or circulating in blood. Several alterations that occur~     repeatedly in certain types of cancers have already been identified. These discoveries have~     led to the development of new drugs that target those alterations. More remain to be~     discovered.~      Some of the alterations are found in genes. Genes are composed of DNA letters, which~     contain the instructions that tell the cells in our bodies how to grow and work. Genes make~     proteins which actually carry out the instructions in our cells.~      The investigator would like to use your DNA to look for alterations in the genes in cancer~     cells and blood cells using a technology called sequencing. Gene sequencing is a way of~     reading the DNA to identify errors in genes that may contribute to the behavior of cells.~     Some changes in genes occur only in cancer cells. Others occur in normal cells as well, in~     the genes that may have been passed from parent to child. This research study will examine~     both kinds of genes.~      One of the scientific goals of this research study is to perform gene sequencing (gene~     tests) on your cancer cells (obtained from biopsies or surgery) and normal tissues (usually~     blood). The results of the gene tests will be used to try to develop better ways to treat~     and prevent cancers. As part of this work, we may also learn things about the genes in your~     normal cells. However, because interpretation of these tests will require further study,the~     investigator will not disclose these results to participants who participate on this~     component of the study.~   "
87431|NCT01912950|"~     The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety~     and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body~     hair.~      Subjects will have a designated treatment area on one forearm divided into four equal-size~     quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants~     will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments,~     spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final~     treatment.~   "
87432|NCT01912937|"~     To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel~     coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or~     restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).~   "
87433|NCT01912924|"~     A study for patients who have chronic postoperative pain who had knee replacement surgery.~     If qualified, a 14 day trial and an implantation of spinal cord stimulator for control of~     pain will be administered. This study will evaluate effectiveness of pain control. Subjects~     will be followed for one year post implantation.~   "
87434|NCT01912911|"~     The investigators goal in this study is to examine the feasibility and efficacy of AliveCor~     iphone case monitoring device in monitoring patients after AF ablation by comparing~     transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor~     (TTM).~      A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM~     system from the patient's perspective~   "
87435|NCT01912898|"~     Lack in vitamin D reduces the absorption of calcium in the body; accelerates bone loss tnd~     may increase the risk of fractures due to osteoporosis. An algorithm that will allow~     immadiate and non -invasiv quanification of vitamin D levels will shorten the time of~     diagnosis; reduce lab costs and prevent hazards or discomfort to patient associated with a~     blood test.~      The goal of the study is therfore to develop a non invasive method for quanitifying vitamin~     D levels in the body using specroscopy.~      40 subgects will be recruited: 20 hospitalized patients in the endocrinology departmet,~     diagnosed with vitamin D deficiency. and 20 healthy subjects. Spectroscopy will be used with~     wisible lighy on the subject's skin and middle infrared (MIR) on the blood sample to find~     correlation with the chemical lab test results.~   "
87436|NCT01912885|"~     INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society~     as urgency, with or without incontinence, usually with increased urinary frequency and~     nocturia. It is difficult to estimate the prevalence of this syndrome because many patients~     do not seek medical help, despite considerable negative impact on quality of life. Lower~     urinary tract dysfunctions can be treated using electrical stimulation of the posterior~     tibial nerve. This therapy is conservative, effective, inexpensive and promotes high~     adhesion to treatment. It has good results, decreasing symptoms of urgency,~     urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the~     parameters of this technique, further research is necessary. OBJECTIVE: To compare the~     effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for~     treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized~     clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for~     at least six months prior to the beginning of the study. The subjects will be divided into~     five groups: group 1 (placebo group), group 2 (electrical stimulation of one leg once a~     week), group 3 (electrical stimulation of one leg twice a week), group 4 (electrical~     stimulation of two legs one a week) and group 5 (electrical stimulation of two legs twice a~     week). Physical evaluation will be done at the beginning and at the end of the treatment.~     Evaluation will be done using the King s Health Questionnaire, the International~     Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire,~     a three day urinary diary and a table for follow-up treatment.~   "
87437|NCT01912872|"~     To assess efficacy and safety of omalizumab treatment during 12 months in order to reduce~     the use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe~     IgE-mediated asthma inadequately controlled with high doses of corticosteroids.~   "
87438|NCT01912859|"~     The purpose of Next Steps pilot intervention is to develop and test a new program designed~     to help low-income multiethnic families with overweight or obese children achieve long-term~     maintenance of healthful behaviors following completion of Hennepin County Medical Center's~     (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).~   "
87439|NCT01912846|"~     The purpose of this 5-year interventional study is to design, implement, and evaluate the~     effectiveness of an intervention aimed at facilitating prognosis communication and~     end-of-life care decision-making to increase the extent of congruence between the patient's~     preferred and actual EOL care received and patients' and family caregivers' QOL and~     psychological well-being, reduce futile aggressive healthcare resources utilization at~     end-of-life, and facilitate bereavement adjustment.~   "
87441|NCT01912820|"~     This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green~     tea polyphenols in the prostate tissue of men taking green tea extract and undergoing~     radical prostatectomy. Side effects of green tea extract and quercetin in combination with~     green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have~     anticancer and cancer preventative effects in a number of malignancies. Likewise, in~     preclinical studies quercetin was found to enhance the anticancer effects of green tea. This~     trial is designed to translate these findings forward in a short-term human intervention~     trial.~   "
87442|NCT01912807|"~     The aim of this study was to investigate the efficacy of intraoperative intravenous dextrose~     in preventing POV in pediatric population undergoing dental day surgery.~      Post-operative vomiting (POV) in children is a frequent complication. Studies using~     intravenous (IV) fluids containing dextrose in the perioperative period have shown~     improvement of POV in adults. Similar studies have not been done in children.~      Knowing that Intravenous (IV) fluids containing dextrose are safe and commonly used in the~     paediatric population, this intervention could potentially reduce the amount of rescue~     antiemetic medications and improve recovery in same-day surgery paediatric patients.~   "
87443|NCT01912794|"~     To maintain stable body balance in daily activities, the ability to respond to external~     perturbations is an essential factor. Such capacity is limited in pathological conditions,~     such as in stroke, in which postural control is impaired due to lesions to the central~     nervous system. Impairment to postural control increases body sway during upright posture~     and leads to augmented frequency of falls. In this sense, the identification of mechanisms~     involved in body balance disorders after stroke is particularly important in situations of~     postural perturbation. The purpose of this project is to evaluate reactive postural~     responses to unpredictable external perturbations, analyzing postural dysfunctions caused by~     lesion to different brain areas as a result of stroke, and test principles of dynamic body~     balance rehabilitation.~   "
87444|NCT01912781|"~     The purpose of this study is demonstrate substantial equivalence of an investigational~     contact lens disinfecting solution to a commercially available contact lens solution in gas~     permeable lens wearers.~   "
87445|NCT01912768|"~     The purpose of this study is demonstrate substantial equivalence of an investigational~     contact lens disinfecting solution to a commercially available contact lens solution in~     silicone hydrogel and soft contact lens wearers.~   "
87446|NCT01912755|"~     The aim of this study was to verify the effectiveness of an anesthetic called articaine for~     dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine.~     Two types of local anesthesia (oral injection) in accordance with the solution used were~     performed. For patients anesthetized with articaine, an injection of anesthesia close to the~     tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the~     bottom of the mouth was made. Differences between both techniques are mainly regarding the~     area of numbness. In the injection with articaine only a small part of the lip and the tooth~     was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth~     and half of the tongue on the same side was numbed. The treatment was electronic randomized~     and there was equal chance to one or another treatment. The investigators are studying this~     new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to~     an emergency treatment, if it really decreases the feeling of numbness and discomfort during~     the service. Patients receiving articaine were submitted to cone beam exam at no cost.~   "
87447|NCT01912742|"~     Obesity has become a global epidemic with huge public health implications. Although clinical~     significant weight loss (WL) can be achieved by a combination of diet and behavioral~     modification, strong metabolic adaptations, with increased appetite and suppressed energy~     expenditure, are activated, which compromise WL maintenance and increase the risk of~     relapse. The aim of this project is to investigate the potential role of WL rate in~     modulating such responses. More specifically, the investigators want to determine if a~     similar WL achieved rapidly vs slowly induce the same compensatory responses to weight~     reduction. A secondary aim is to assess if speed of weight loss can influence motivation. A~     large battery of assessments will be performed before and after weight reduction including~     body composition, resting metabolic rate, substrate oxidation, exercise efficiency, fasting~     and postprandial release of several appetite-regulating hormones, subjective feelings of~     hunger and fullness and motivation. This project can bring large practical benefits~     concerning the design of weight loss programs to minimize weight relapse.~   "
87448|NCT01912729|"~     The mission of this project is to develop novel systems of care that can provide~     efficacious, scalable, cost-effective, participant friendly behavioral intervention~     technologies (BITs) for the prevention of depression in adolescents. The investigators~     define BITs as interventions that use information and telecommunications technologies such~     as the internet, mobile or traditional phones, computers and/or other technologies to~     support and deliver psychological and behavioral interventions. Through usability testing,~     focus interviews, and field trials, investigators may modify the technologies and~     intervention based on immediate usage data.~   "
87449|NCT01912716|"~     It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose~     of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation~     of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk~     patients. However, the optimal dose required is not known. The purpose of this study is to~     determine whether a dose of 200 mg, administered as rectal suppositories, is more effective~     than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted~     tube with a camera is passed down the patient's throat and allows for evaluation of the bile~     duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP~     pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this~     complication than others. Our hypothesis is to compare the efficacy of these two dose~     regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the~     frequency and severity of post-ERCP pancreatitis in high-risk patients.~   "
87486|NCT01912235|"~     Arginine synthesis in mammals is a complex process involving at least 8 enzymes and~     intracellular and interorgan transfer of substrates.~      The investigators have shown in our neonatal studies that there is no conversion of~     glutamate to arginine but proline label appears in ornithine, citrulline and arginine. It is~     clear therefore that arginine is synthesized in human neonates from proline.~      In adults the source of the carbon backbone is less clear.~   "
87450|NCT01912703|"~     It is well-known that preterm delivery can be accompanied by complications. One of these~     complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according~     to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes,~     including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social~     difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim~     of this study is to determine whether they do have any neurodevelopmental outcomes.~   "
87451|NCT01912690|"~     The hypothesis of the study is that aerobic conditioning following acute heart attack will~     improve autonomic function and electrical stability of the heart.~   "
87452|NCT01912677|"~     This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive~     regimens for women with severe hypertension in pregnancy. Women presenting with severe~     hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of~     three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the~     efficacy, safety and side effects of these three oral regimens for management of~     hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of~     severe hypertensive parturient women is more effective than treatment with labetalol or~     methyldopa in controlling high blood pressure within six hours.~   "
87453|NCT01912664|"~     The mission of this project is to develop novel systems of care that can provide~     efficacious, scalable, cost-effective, participant friendly technology assisted behavioral~     interventions (TABIs) for the treatment of depression in adults. The investigators define~     TABIs as interventions that use information and telecommunications technologies such as the~     internet, mobile or traditional phones, computers and/or other technologies to support and~     deliver psychological and behavioral interventions. Through usability testing, focus~     interviews, and field trials, investigators may modify the technologies and intervention~     based on immediate usage data.~      The goal of this field trial is to tailor, and test, a peer networked intervention in adults~     65 years of age or older. Two versions have been created and will be tested, one with and~     one without an online social network. The purpose of this study is to pilot a novel~     intervention, examine methods to improve adherence to Internet based interventions (e.g.,~     peer network), and ultimately, to overcome the numerous barriers to treating depression in~     later life.~   "
87454|NCT01912651|"~     Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of~     wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve~     the healing of skin grafts and reduce the risk of infections after surgery in these~     patients. It is known that antibiotics, like all medications, have side-effects although~     these are rare. This research study is designed to show us whether antibiotics improve wound~     healing or not, so that we may determine if we should continue using antibiotics even if~     they have side-effects in some patients.~      Our hypothesis is that patients treated with post-operative, systemic antibiotics will~     demonstrate a statistically significant improvement in the survival of their facial full~     thickness skin grafts compared to patients who are not treated with systemic antibiotics.~   "
87455|NCT01912638|"~     The purpose of this prospective randomized study is to assess and compare the clinical~     efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive~     viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled~     steroid induced glaucoma.~   "
87456|NCT01912625|"~     This phase I trial studies the side effects and the best dose of trametinib when given~     together with combination chemotherapy and radiation therapy in treating patients with stage~     III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving~     trametinib, combination chemotherapy, and radiation therapy may be a better treatment for~     non-small cell lung cancer.~   "
87457|NCT01912612|"~     Early stage breast cancer is typically treated with surgery, chemotherapy, radiation~     therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors~     have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin~     norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety,~     fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.~      Pilot data suggest that duloxetine is effective in management of endocrine~     therapy-associated musculoskeletal pain, and a randomized placebo controlled trial of~     duloxetine has demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain.~     In this mechanistic study of duloxetine versus placebo, we will investigate the change in~     pain sensitivity with treatment in order to evaluate both why duloxetine is effective for~     management of pain for some patients, as well as predictors of who is likely to benefit from~     duloxetine. A total of 84 women with early stage breast cancer who have chronic pain~     following treatment, as well as 48 women who are pain free, will be enrolled. All subjects~     will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain~     will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments~     before treatment and after 4 weeks of full-dose treatment.~   "
87458|NCT01912599|"~     Purpose: To study the feasibility of a larger study by determining the tolerability of~     measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory~     fashion with automatic devices.~      Participants: 20 patients with moderate to severe normal tension glaucoma and 20~     non-glaucomatous patients.~      Procedures (methods): Both BP and IOP will be measured automatically in each participant in~     an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately~     sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person~     trained in ambulatory BP monitoring devices. The device will be set up to automatically~     inflate every 30 minutes during the day and every hour during the night to measure and~     record the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG,~     Lausanne, Switzerland); the measurements will be taken and recorded every 10 minutes. The~     contact lens will be inserted by eye doctors (investigators). Both monitoring devices will~     be removed the following day.~   "
91209|NCT01863368|"~     The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE®~     lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate~     the safety of Systane® ULTRA after 3 months of use.~   "
87459|NCT01912586|"~     Although the high prevalence of erectile dysfunction (ED) was detected among male patients~     after the treatment for colorectal cancer, published reports depicting the erectile~     dysfunction experience of patients with colorectal cancer ot underpin service development~     are insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal~     cancer are not routinely offered information and treatment for erectile dysfunction.However,~     investigations on patients after surgery for prostate cancer could provide some potentially~     useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the~     return of erections after nerve-sparing radical prostatectomy has been established, which~     may benefit rectal cancer patients after surgery with ED.~      Laparoscopic surgery, although technically demanding and associated with a long learning~     curve, has the advantage of clear visualization for the smallest structures,including the~     autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate~     preservation of the pelvic autonomic nerves.~      This study aimed to identify whether early intervention is effective at reducing the rate of~     ED at 12 months.~   "
87460|NCT01912573|"~     The goal of this study is to determine if nasal naloxone is inferior to standard care for~     naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and~     Scioto counties in southern Ohio will be randomized to provide either standard care or nasal~     (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes~     administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO)~     methods.~   "
87461|NCT01912560|"~     The purpose of this study is to determine the safety and efficacy of different doses of~     CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will~     evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with~     moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in~     patients with hypercholesterolemia who are on a statin.~   "
87462|NCT01912547|"~     Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve~     significant blood loss with considerable blood and product transfusion. Thromboelastography~     (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that~     records kinetic changes in clot formation. This study aims provide a better understanding of~     the coagulation profile of these patients, and will form the basis of a TEG-based~     transfusion algorithm for future surgeries for mesothelioma.~   "
87463|NCT01912534|"~     The purpose of this trial is to determine whether treatment with valsartan will have~     beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that~     reflect myocardial structure, function and biochemistry.~   "
87464|NCT01912521|"~     This pilot study is a non-randomized controlled cohort study evaluating the impact of social~     network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes,~     food security, social support, HIV knowledge, and risk behaviors among people living with~     HIV/AIDS, as well as members of their associated social support networks. The intervention,~     known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education~     program on HIV biology, interpersonal communication and community mobilization for both HIV~     positive individuals and their self-selected social network members selected irrespective of~     HIV status. Investigators hypothesize that participation in the microclinic program will~     improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV~     knowledge and food insecurity and will reduce HIV-related stigma, as compared to~     participants in control communities.~   "
87465|NCT01912508|"~     Cervical length is a already known predictor for preterm labor. In this study the~     investigators want to examining the hypothesis that cervical curvature is also a predictor~     for preterm labor and that moderate transducer pressure influence cervical length.~      study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound~     unit ether for routine screening or because of preterm labor.~      During their examination cervical length and curvature measurements will be taken. Another~     measurement will be taken after applying moderate cervical pressure.~      The investigators will compere cervical contour and pressure influence between groups and~     according to cervical length Demographic data will be taken at the time of recruitment and~     pregnancy outcome measures in a later telephone interview.~   "
87466|NCT01912495|"~     Prospective open label proof of concept feasibility interventional clinical trial in which~     60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in~     addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds~     at week 4.~      The primary hypothesis of this study is that the subset of patients with a Rapid Viral~     Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and~     ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.~   "
87467|NCT01912482|"~     The cardiorespiratory training can increase muscle strength ventilatory.~   "
87468|NCT01912469|"~     To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise~     induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise~     test on downhill treadmill.~   "
87469|NCT01912456|"~     The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing~     hereditary angioedema attacks when it is administered under the skin of subjects with~     hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each~     subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period~     and who are eligible will then enter the treatment phase which comprises two sequential~     treatment periods. In the treatment phase, subjects will be randomized to one of four arms~     consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment~     period and treatment with low- or higher-volume placebo in the other treatment period. The~     study will measure the number of hereditary angioedema attacks that subjects experience~     while receiving each treatment.~   "
87470|NCT01912443|"~     To assess the safety profile of bevacizumab in combination with chemotherapy for the~     treatment of metastatic colorectal cancer~   "
87484|NCT01912261|"~     The purpose of this research study is to examine how an oral iron supplement (Feramax®)~     influences fatigue during early postoperative recovery (at three months) among CABG patients~     and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia,~     and medication adherence).~      It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally~     (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence~     Fatigue Scale (ICFS)), compared to patients receiving a placebo.~   "
87471|NCT01912430|"~     New payment methods such as Accountable Care Organization (ACO's) and medical homes~     facilitate are new models for providers to deliver cost effective, quality patient outcomes.~     Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic~     interventions with an intelligent information technology platform that offered validated~     protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated~     program of Integrated Care Coaching (ICC), which was branded as VitalCare, and implemented~     with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare~     costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for~     participants.~   "
87472|NCT01912417|"~     The aim of this study is to evaluate the effect of aerobic exercise during dialysis on the~     hemodialysis efficacy in the removal of small molecules measured by continues spend sampling~     of dialysate (liquid metabolites produced by the body which is disposed) technique.~   "
87473|NCT01912404|"~     The main purpose of the study is to test if taking a study drug called emricasan (also known~     as IDN-6556 and PF-03491390) will affect overall patient survival after one month of~     treatment.~   "
87474|NCT01912391|"~     Selegiline is superior to placebo in improving psychological and physical functioning in~     patients with Borderline Personality Disorder.~   "
87475|NCT01912378|"~     The study will investigate the effects of an intranasal administration of oxytocin (OT) to~     parents of children with autism spectrum disorders (ASD) on the quality of~     mother-father-child interactions. Physiological and behavioral measures of parent-child~     triadic interaction quality will be assessed.~      H1: Parents who receive OT will demonstrate greater parental engagement and nonverbal~     prosocial behaviors compared to parents who receive placebo.~      H2: Children with ASD whose parents receive OT will have increased nonverbal prosocial~     behaviors during the discussion and play tasks compared to children whose parents' receive~     placebo.~      H3: Parents who receive OT will demonstrate increased behavioral and physiological synchrony~     with their child during the discussion and play tasks compared to parents who receive~     placebo and their child.~   "
87476|NCT01912365|"~     Elbow fractures are very common in young children. Type I supracondylar fractures are stable~     fractures to the elbow that are treated conservatively across the world and typically heal~     very well without complications. There are several treatment options, including an above~     elbow cast or long arm splint. This study aims to determine if one treatment is no worse~     than the other in order to standardize the treatment of these fractures at our institution.~     The investigators hope to save families from extra hospital visits and reduce the amount of~     x-rays required for treatment of these fractures.~   "
87477|NCT01912352|"~     The aims of the current study are to examine gene-environment interactions associated with~     norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic~     changes in norepinephrine pathway are associated with differences in functional connectivity~     of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore,~     this study aims to examine neurobiological markers, such as intermediate neuroimaging~     phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD.~     Through evaluating drug responses and side effects with the associated measures of clinical,~     neuropsychological and neuroimaging characteristics, investigators would like to investigate~     predictors of treatment response associated with NE system genes in ADHD.~   "
87478|NCT01912339|"~     To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary~     symptoms secondary to benign prostatic hyperplasia (BPH).~   "
87479|NCT01912326|"~     Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to~     prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with~     optimized pacemaker programming.~      Hypothesis:~      Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to~     programming DDDR-(60) without AF Suppression when all other parameters are optimized.~   "
87480|NCT01912313|"~     Rectal biopsies from IBS patients or healthy subjects will be taken.~      Biopsies will be used for:~        1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium~          imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and~          real time PCR (Polymerase chain reaction);~        2. culturing biopsies~      On the basis of these observations, the general aim of the study is to move a significant~     step forward in the current knowledge on human ENS (enteric nervous system) in IBS by~     establishing a live imaging method to record enteric nerves activity in small intestinal~     biopsies from humans. This development is unique in its kind as not other research groups~     have reported successful live recordings with calcium imaging in this preparation.~      In particular, the investigators aim:~        1. to develop and validate the technique to measure activity in human enteric nerves in~          the submucous plexus isolated from rectal biopsies from healthy subjects and IBS~          patients;~        2. to characterize this nerve activity in healthy subjects and IBS patients using both~          calcium imaging to evaluate the effect of different neuromodulators,~          immunohistochemistry and rtPCR to determine receptor expression levels and identify~          neurons and glial cells in the submucous ganglia;~        3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines~          compared to healthy subjects and their potential to activate neurons.~        4. to evaluate the influence of different food constituents (cow‟s milk, wheat, yeast,~          gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell~          activation/degranulation in biopsies of IBS patients compared to healthy subjects.~        5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS~          patients and healthy volunteers by the use of metabolic profiling~   "
87481|NCT01912300|"~     Sedentary behaviors have been shown to increase food consumption among youth and adults. The~     recent active video games devices have been suggested to compensate for the increased energy~     intake they induce by the increased energy expenditure they generate. To date no study has~     been conducted to question whether or not such modern sedentary activities induce energy~     consumption modification in youth. The aim of this work is to compare the impact of a~     passive video games vs. active video games vs. physical exercise in terms of subsequent~     energy intake and appetite feelings in normal weight and obese youth.~   "
87482|NCT01912287|"~     The purpose of this randomized study is to examine the comparative efficacy of yoga,~     cognitive behavioral therapy, and stress education, a previously employed control condition,~     for patients with Generalized Anxiety Disorder.~   "
87483|NCT01912274|"~     The purpose of this study is to determine the safety and effectiveness of pracinostat when~     combined with azacitadine for patients who are 65 years of age or older and have Acute~     Myelogenous Leukemia (AML)~   "
87485|NCT01912248|"~     Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac~     patient, how high?~   "
91586|NCT01858402|"~     We conducted a prospective, randomized double-blind study to compare the effectiveness of~     intravenous paracetamol and dipyrone for preventing pain during early postoperative period~     in school-age children undergoing lower abdominal surgery with spinal anesthesia.~   "
87488|NCT01912209|"~     The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of~     Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular~     disease. Second, the investigators wish to encourage a healthy lifestyle through~     personalized nutrition and fitness advice, delivered as part of a web based program, which~     will in turn lead to increases in heart healthy behaviors such as increased consumption of~     heart healthy foods, increased exercise initiation, and more positive attitudes about~     health. To assess this, the investigators plan to randomize 200 employees with Metabolic~     Syndrome to either the new web-based diet and lifestyle program, or to care-as-usual, which~     is the currently offered MyWellnessAdvantage and WebMD websites. The investigators~     hypothesize that the web-based group will show greater improvements in physical health (such~     as weight loss, cholesterol reduction, etc.) as well as increased consumption of heart~     healthy foods, exercise initiation, and quality of sleep as measured by surveys administered~     at the 4,8, and 12 month follow-up appointments.~   "
87489|NCT01912196|"~     The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in~     reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate~     response to current antidepressant therapy.~   "
87490|NCT01912183|"~     This is a pilot study to examine the feasibility of implementing an objective physical~     activity and sleep monitoring tool into a pediatric weight management program in conjunction~     with a personal health record (PHR) for children and their families. This feasibility study~     is intended to provide proof of concept in the incorporation of monitoring devices within~     the PHR for pediatric patients and their families. Additionally, the investigators will~     examine whether the PHR helps to empower pediatric patients, their families and the health~     care team to more effectively monitor the patient's behavior change. Participants will be~     randomized to receive, or not receive, augmented communication with the health care team~     between clinical in person visits.~   "
87491|NCT01912170|"~     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and~     related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil~     (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25),~     rich in omega-6 fatty acids, will be selected as a controlled oil. The intervention will~     start from the third trimester of these pregnant women and finish at the 4wk after the birth~     of their children. The investigators hypothesize that omega-3 fatty acids could improve~     insulin sensitivity and glucose metabolism in these patients.~   "
87492|NCT01912157|"~     Handling of complex health situations (as defined by multimorbidity) in partnership:~     communication between romantic partners; subjective illness perception; coping with~     stressful experiences due to multimorbidity.~      Intervention : Expressive Writing about subjective illness perception vs. Writing about~     individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire)~     Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of~     partnership and others)~   "
87493|NCT01912144|"~     Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and~     are characterised by a phenol ring in their structure. The phenolic compounds we are going~     to focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates~     formed between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant~     activity (2).~      HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet~     (3) and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few~     studies suggest protective effects for cardiovascular diseases (5), neurodegenerative~     diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field~     are obtained from in vitro and/or in animal, and it is difficult and dangerous to~     extrapolate between these and risk in humans of development or progression of particular~     health conditions, more human studies are therefore needed.~      We aim to compare people that metabolise the best CGAs from coffee to those that metabolise~     them the least well. This will be achieved by measuring the metabolites in urine. The effect~     of CGAs on the human body does not only depend on the amount ingested, but also on the~     quality of the metabolism, we therefore also want to determine which mechanisms are~     responsible for inter-individual variations in order to identify any link with health~     biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.~      For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers~     will be recruited at the School of Food Science & Nutrition. If they meet the selection~     criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36~     hours, participants won't be allowed to drink coffee, they will be asked to follow a diet~     low in phenolic acids and keep a record of their meals. On the first day of the study, a~     single dose of coffee rich in antioxidants will be given to the participant and urine will~     be collected from that time until 36 hours after coffee consumption. Participants will be~     followed again after 5 to 6 weeks.~   "
87494|NCT01912131|"~     This study is being done to get individuals' feedback on advanced care planning and decision~     making.~      This study is divided into two parts (Part 1 and Part 2). The purpose of Part 1 is to survey~     people to find out what is important to people with advanced cancer (again, their values,~     such as their goals, concerns and sources of support). This has never been done before in~     the way the investigators are doing it, and that is why this is called a pilot study,~     which is where a new method or treatment is being created and evaluated.~      The purpose of Part 2 is to see if combining a medical options video with a short interview~     about values helps people with how they feel about their medical situation, and what they~     know about their medical options for their medical situation.~   "
87495|NCT01912118|"~     Despite various efforts there is still the need for adequate monitoring of pain and~     nociception during anesthesia. In a previous protocol the investigators measured pain~     responses during anesthesia based on single end‐points, eg heart rate,blood pressure and~     pulse transit time. None of these parameters provided sufficient information regarding~     nociception. The investigators therefore want to further investigate this matter using a~     composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures~     the magnitude of the autonomic response to painful stimuli. The NoL combines information~     from several physiological parameters, which represent different autonomic pathways. The~     multi‐parameter approach empowered with state‐of‐the‐art signal processing and machine~     learning techniques. In the current study the investigators will measure the NoL in ASA 1‐3~     patients undergoing elective surgery under general anesthesia. The investigators will~     measure NoL responses and the occurrence of patient movement upon the administration of a~     painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube,~     Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.~   "
87496|NCT01912105|"~     Cleaning the endotracheal tube with a specifically designed device results in lower amount~     of secretions at extubation, assessed by micro CT scan~   "
87501|NCT01912027|"~     The open Latarjet techniques has benn considered as an effective treatment on anterior~     shoulder instability.Over the past decade there has been a shift from open to~     all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less~     postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic~     Latarjet techniques would have better clinical and radiographic outcomes than the open~     Latarjet Techniques on anterior shoulder instability.~   "
87502|NCT01912014|"~     The purpose of this feasibility study is to develop and initially test a dialogue-based~     psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an~     acute stroke. The intervention is carried out by primary care registered nurses or other~     appropriate health professionals. The intervention included persons with and without~     aphasia.~   "
87503|NCT01912001|"~     Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home~     hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to~     conventional in-center hemodialysis. Patients with end stage renal disease, that is failure~     of the kidneys such that dialysis is required, are at high risk for adverse health events~     especially during a period of transition following a change in care settings. The~     investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone~     follow-up, which is targeted to minimize gaps of care during transitions in care.~      The investigators aim to have clinicians follow patients by telephone if they meet one of~     the following four criteria;~        1. Discharge from hospital.~        2. Having an interventional procedure.~        3. Prescription of an antibiotic.~        4. Completion of Home Dialysis training.~      The major goal of this HDVW initiative is to provide appropriate and effective supports to~     medically complex patients in a targeted window of vulnerability.~   "
87504|NCT01911988|"~     The purpose of this study is to determine association between Peripheral Immune Cells(PIC)~     and recurrence in stage II/III colorectal cancer~   "
87505|NCT01911975|"~     Lacosamide is a functionalized amino acid with antinociceptive properties in inflammatory~     and neuropathic pain, and displays a unique mechanism: it enhances slow inactivation of~     Nav1.3, Nav1.7, and Nav1.8.~      Nav1.7 is expressed predominantly in nociceptive and sympathetic neurons. Gain-of-function~     mutations have been described in Nav1.7 that result in extreme pain disorders such as~     SCN9A-associated small fiber neuropathy. In the disease states genetically linked to a~     gain-of-function of Nav1.7, the sodium channel is mutated to increase the sodium influx~     resulting in a hyperexcitable sensory neuron, and a resultant sensation of pain.~      The objective of the study is to determine the efficacy and safety of lacosamide, a sodium~     channel blocker, in patients with pain due to SCN9A-associated small fiber neuropathy.~   "
87506|NCT01911962|"~     To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural~     orifice surgery VS transabdominal surgery.~   "
87507|NCT01911949|"~     Hip replacement surgery is one of the most common elective surgeries in Canada and with this~     surgery, there is considerable pain after the operation. By decreasing the amount of pain~     after surgery, the patients may be able to move and walk quicker, resulting in easier~     physiotherapy sessions, shorter hospital stays and may help to avoid adverse outcomes like~     nausea and vomiting and being overly sedated. By using ultrasound guided femoral nerve~     block, it may be an alternative for pain management with minimal side effects for patients~     having hip replacement surgery.~   "
87508|NCT01911936|"~     This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.~   "
87509|NCT01911923|"~     Atelectasis is common during and after general anesthesia. The investigators hypothesized~     that a ventilation strategy with a combination of 1) continuous positive airway pressure~     (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen~     fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce~     the area of postoperative atelectasis.~   "
87510|NCT01911910|"~     Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common~     and can lead to severe disability or death. Changes in the body leading to heart attacks and~     strokes usually develop over decades as a result of smoking, diet, and lack of exercise,~     obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly~     reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have~     no known heart disease to take part in the NHS Health Check, which measures each person's~     individual risk of developing a heart attack or stroke and encourages them in a face-to-face~     meeting to take part in programmes to help them to give up smoking, lose weight etc. where~     necessary. In this new clinical trial the investigators will test whether computer-tailored~     electronic (e)-coaching via email and the internet can help people make the necessary~     changes in their lifestyle to reduce the risk of heart attacks and strokes.~   "
87511|NCT01911897|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
87512|NCT01911884|"~     The principal objective is to assess the general health status and the sexual health status~     of women with Rokitansky syndrome having received a surgical or non surgical treatment.~      The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To~     search a correlation between the anatomical result, the general and sexual quality of life.~     To compare the different techniques of medical follow-up in terms of anatomic results,~     general quality of life, sexual quality of life, complications and morbidities.~      To evaluate social inclusion of these women with their family situation, social and~     professional category and their job.~      At the same time, we propose an evaluation with a psychologist to study the impact of the~     announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.~   "
87513|NCT01911871|"~     The investigators' primary objective is to study prevalences of myocardial iron overload,~     defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected~     with thalassemia, sickle cell disease, and myelodysplasia.~   "
87514|NCT01911858|"~     The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on~     III degree burns by quantifying the concentration of silver in the blood during treatment~     and thus to show that the amount of silver absorbed will be no greater than those reported~     in the literature.~   "
91844|NCT01855035|"~     The purpose of this study is to assess whether repeated enhanced and prolonged ECG~     monitoring after ischemic stroke results in a higher detection of atrial fibrillation~     (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).~   "
87516|NCT01911832|"~     The incidence of cancer of the esophagogastric junction has rapidly risen in recent three~     decades, and surgery still remains the optimum therapy. For Siewert's type II and III~     cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after~     subtotal gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy~     after total gastrectomy brings high survival rate and low local recurrence rate which may~     also induces pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after~     subtotal gastrectomy needs reconstruction of the gastric tube and the width of~     reconstruction tube was a key factor to predicate prognosis. However, no evidence supplies a~     comprehensive standard on the width of reconstruction tube which often ranges from 3 cm to 6~     cm. Both narrow and wide reconstruction tubes have their own advantages and disadvantages.~     So the prospective trail recruits patients into three groups: total gastrostomy group (TG~     group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). And the~     investigators compare the quality of life using integrated questionnaire of QLQ-STO22 and~     QLQ-C30 and related symptom relief as main endpoints.~   "
87517|NCT01911819|"~     The purpose of this study is to compare new bone formation following bone graft in sinus~     using three different commercially available bone graft materials. The study hypothesis is~     that there is no difference in new bone formation among three bone graft materials under~     microscope.~   "
87518|NCT01911806|"~     This study aim to investigate the effects of back care pillow, in adjective with standard~     physical therapy treatment for chronic non-specific low back pain.~   "
87519|NCT01911793|"~     Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients.~     Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at~     the level of the stoma is a common cause of bowel obstruction or ileus. This is often~     manifested by decrease or delay in stoma output and is often attributed to edema at the~     level of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma~     at bedside, which often relieves the obstruction until the edema at the level of the stoma~     resolves and stoma function occurs around the temporary tube. At this time, the tube is~     removed and the stoma continues to function normally.~      The purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed~     at the time of stoma creation would reduce the incidence of postoperative ileus in patients~     undergoing major colorectal surgery with creation of a stoma.~   "
87520|NCT01911780|"~     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group~     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +~     hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+~     hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the~     end of the double-blind period in essential hypertensive patients who fail to respond~     adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.~      Patients are assigned to one of the two groups after a 6-week open-label run-in period~     taking T80/H12.5 mg.~      In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide~     12.5 mg will be evaluated in a 52-week extension period.~      In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg~     group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5~     mg group change to the T80/A5/H12.5 mg therapy.~   "
87521|NCT01911767|"~     The primary objective of the study is to prospectively evaluate pregnancy outcomes in women~     with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis~     product during the eligibility window for that product. The Registry-specified Biogen MS~     products being studied are dimethyl fumarate, Pegylated human interferon beta-1a, and~     Dalclizumab High Yield Process (DAC HYP).~   "
87522|NCT01911754|"~     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic~     influenza vaccine in a Japanese pediatric population aged 6 months to 17 years~   "
87523|NCT01911741|"~     A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide)~     formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the~     safety and tolerability of oral formulations.~      Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up~     to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the~     last pharmacokinetic (PK) sampling or after early withdrawal.~   "
87524|NCT01911728|"~     A drug-drug interaction study to investigate the potential pharmacokinetic interaction~     between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin~     (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).~   "
87525|NCT01911715|"~     A study to investigate the excretion routes of radio-labelled MDV3100.~   "
87526|NCT01911702|"~     Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to~     intra-abdominal generalized infection. With the exception of the primary ones which are the~     result of a bacterial translocation from the gastro-intestinal tract or an abdominal~     contamination for hematogenous way sometimes treatable with medical therapy alone,~     peritonitis represents a complex condition that requires an early surgical treatment.~      Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when~     associated with a systemic framework of severe sepsis. This variability is linked to a~     number of risk factors, including advanced age of the patients, the presence of comorbidity,~     male sex, a poor nutritional status, and a number of re-operations; as well as specific~     characteristics related to the type of infection, the timing of surgery, the beginning of an~     appropriate and early antibiotic therapy.The post-operative treatment of the patient with~     peritonitis significantly affects the outcome of the same. The presence of peritonitis and~     then the seizure of large volumes of liquids and the possible state of systemic vasodilation~     induced by the infectious process, provide a framework of hypovolemia. There is a literature~     that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an~     element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes~     determined by a different volemic strategy.~   "
87527|NCT01911689|"~     To quantitatively analyze the T2* values of the head, body, and tail of normal pancreas, and~     observe the value of GRE T2*-weighted MRI in the diagnosis of acute pancreatitis and the~     relationship between the T2* value and the severity of AP.~   "
93521|NCT01833039|"~     The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell~     Lymphoma (MCL) with early access to an investigational medication called ibrutinib~     (PCI-32765) and to collect safety information about the drug.~   "
87529|NCT01911663|"~     This study is a randomized, double-blind, placebo-controlled clinical trial designed to~     evaluate the effect of Korean red ginseng supplementation on glucose control in subjects~     with impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes~     Mellitus and to establish a clinical evidence on glucose control effect of KRG.~   "
87530|NCT01911650|"~     The overall goal of this proposal is to correlate ultrasound elastography technique with~     more standard clinically based outcome measures within the setting of a small sample sized~     group of patients affected by moderate-to- severe, chronic (>6months) midsubstance Achilles~     tendinopathy (AT).~   "
87531|NCT01911637|"~     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and~     tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to~     receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).~   "
87532|NCT01911624|"~     Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with~     staphylococcus aureus bacteraemia.~      The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct~     thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus~     bacteremia.~   "
87533|NCT01911611|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be~     randomized to receive single ascending doses of either RO6870868 or placebo, with or without~     food.~   "
87534|NCT01911598|"~     This open-label, multicenter study will evaluate the safety, tolerability, and~     pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU~     or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There~     are two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage~     (Stage I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during~     a DLT Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both~     arms. In Stage II, participants will be enrolled to further characterize the safety,~     pharmacokinetics, and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU~     or carboplatin + paclitaxel at the identified recommended Phase II dose.~   "
87535|NCT01911585|"~     The purpose of this study is to determine whether 60-minute sessions of prolonged exposure~     (PE) are as effective as the standard 90-minute session for treating posttraumatic stress~     disorder (PTSD). Participants will include patients ages 18 or older with a current~     diagnosis of PTSD who are seeking treatment in our clinic. Patients who have current~     substance dependence, psychosis, and suicidal ideation with intent and plan may not be~     suitable for receiving PE and may be offered another treatment or referred to a different~     treatment center. Participants will be randomized to receive either the 90- minute or~     60-minute PE session. A blind evaluator will assess for pre-treatment, post-treatment, and~     follow-up levels of symptom severity using the PTSD Symptoms Scale Interview (PSS-I).~     Participants will attend weekly treatment sessions with any of our faculty members and will~     complete self-report measures at every session (see below).~   "
87536|NCT01911572|"~     Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria~     spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia,~     meningitis and others. The various bacteria of the streptococcus family are an important~     cause, often leading patients to require intensive care despite which, for some strains, one~     in five patients die. One notable form is called necrotising fasciitis, a condition where~     bacteria rapidly spreads through and destroys the layers of tissue just under the skin.~      As individuals vary greatly in their risk of developing such serious infections,~     investigating how the genome, the inherited blueprint of our bodies, of these patients~     differs from that of healthy volunteers can help to explain why the disease develops in some~     and not others. For some streptococcal bacteria such as Streptococcus pneumoniae this~     approach is already proving successful; for others such as the Group A strain~     (Streptococcus pyogenes) it has yet to be explored but carries excellent potential.~      The investigators have secured the support of the Lee Spark Necrotising Fasciitis Foundation~     to recruit from their membership survivors of streptococcal infections and some of their~     family members. The investigators will also ask infection specialists from NHS hospitals to~     invite patients they have looked after. The investigators also have a small existing~     collection. Taking part would involve registering information on a website, discussing the~     study on the telephone and then providing us with a sample of saliva from which the~     investigators can isolate DNA. The investigators would prepare the sample for analysis of~     the genome and compare the patients with both their family and an existing reference~     collection from healthy volunteers using technology that reads the DNA code.~      Our study will be a first key step in renewing efforts to understand the determinants of~     invasive streptococcal infection, which is important for developing better treatments and~     vaccines.~   "
87537|NCT01911559|"~     Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced~     mobility and consequent constipation. Clinicians frequently recommend standing-frames to~     exercise the support reaction in this population, sharing the opinion that the upright~     position may facilitate intestinal transit, although no evidence supports this assumption.~      The investigators conducted this single-subject research to determine the effects of the~     standing-frame on the frequency of evacuation in chronically constipated children with CP~     and quadriplegia.~      Moreover, the investigators studied its effects on the frequency of induction of evacuation,~     the characteristics of the stool and the pain suffered by the child due to constipation~     and/or evacuation.~   "
87538|NCT01911546|"~     A growing number of patients on the kidney transplant waiting list are broadly human~     leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible~     donor. Therefore they wait longer and have increased morbidity and mortality.~     Desensitization with intravenous immune globulin (IVIG) and rituximab with alemtuzumab~     induction improves transplant rates and achieves good allograft outcomes. However, HS~     patients are at risk for viral infections after transplant. We have previously shown an~     increased incidence of BKV infections after desensitization with HS patients having higher~     peak viral loads. Cytomegalovirus (CMV) and polyomavirus BK (BKV) infections place HS renal~     transplant recipients at particular risk. Allograft rejection is associated with both CMV~     and BKV infection. This is of particular concern for HS patients as they are at an increased~     risk of rejection at baseline. Furthermore, the frequent development of leukopenia after~     transplantation often requires the CMV prophylactic agent to be discontinued along with~     lowering immunosuppression. This increases the risk of CMV infection and allograft~     rejection.~      Everolimus was approved for rejection prophylaxis in combination with calcineurin inhibitors~     (CNI). CNI used in the study that led to drug's approval was cyclosporine. There are several~     trials nearing it's completion that utilize low dose tacrolimus instead. In 2012 Novartis~     published data from several trials showing superior outcomes using everolimus + low dose~     tacrolimus. This combination is currently approved in EU. It is also a combination that is~     standard of care (SOC) at our center for patients on everolimus.~      This study aims to demonstrate that use of everolimus as part of a maintenance~     immunosuppression regimen may decrease viral infections without lowering overall~     immunosuppression thus improving allograft function and survival.~   "
87842|NCT01907555|"~     This project will make it possible to better understand the natural history of Cohen Syndrom~     and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic~     management of patients. It will also provide a better description of Cohen-like syndrome for~     genetic counselling for the families concerned.~   "
87539|NCT01911533|"~     Hypothesis:~      Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows~     application of lung protective ventilation. This downgrading of mechanical ventilation~     promotes better and more quickly lung recovery.~      Aim:~      The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by~     using an extracorporeal removal of CO2 (ECCO2-R).~      This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome~     (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary~     oedema and shows bilateral densities on chest radiography. The take up of oxygen and the~     loss of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due~     to too much CO2.~      To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated.~     This can be aggressive and harmful for the lungs. With the use of an extra-corporeal~     CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less~     aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover~     pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen~     to the blood and extracts carbon dioxide from the blood) and back into a vein.~      The investigators will use a standard dialysis catheter that will be put in a large vein. To~     prevent clotting of the system, the patient will receive heparin.~      In the study the investigators will work in periods of two hours, the situation before and~     after carbon dioxide removal will be compared. With this study the investigators want to~     prove that the CO2 in the blood decreases with at least 20 % with the use of the~     extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical~     ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to~     the lungs.~   "
87540|NCT01911520|"~     During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain~     good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission~     blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is~     still some neuromuscular blocking activity left in the patient on awakening from anesthesia.~     This is called residual curarization and is known to cause postoperative complications such~     as impairment of respiratory function.~      Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It~     allows for reversing of neuromuscular transmission blocking activity. Until now, all studies~     with sugammadex were performed in non-obese patients.~      Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore~     it is vital to avoid residual curarization. Sugammadex might be an important factor.~      Obese patients have a large total body weight different from ideal body weight. Recent~     research demonstrated that the dose for the neuromuscular blocking agent rocuronium~     (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total~     Body Weight.~      At this moment no data is available on the dose-response relationship of sugammadex in~     morbidly obese patients.~      We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal~     bodyweight, instead of total bodyweight.~   "
87541|NCT01911507|"~     This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and~     erlotinib hydrochloride when given together in treating patients with previously treated~     non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
87542|NCT01911494|"~     This project is being undertaken to test the hypothesis that implementing a community based~     package of care for women with hypertensive disorders of pregnancy will result in overall~     improvement in maternal and neonatal outcomes. This is based on the premise that there are~     three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy~     complications: 1) delays by the woman herself in recognizing the seriousness of her~     condition; 2) delays in her being assessed and then transported to a center capable of~     providing effective and life-saving interventions; and 3) delays in the health facility in~     providing those interventions. The treatments for pre-eclampsia that are poorly accessed in~     LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures~     of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of~     stroke.~      The CLIP pilot and definitive cRCT will investigate whether the community level intervention~     including implementation of the CLIP package (oral antihypertensive therapy when indicated,~     intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility~     when indicated) of care will reduce the incidence of all-cause maternal morbidity and~     mortality.~   "
87543|NCT01911481|"~     The investigators are carrying out a study of 164 pregnant women, with breech presentation~     at term who will undergo to external cephalic version. The investigators' goal is to know if~     oral maternal hydration can increase the successful of external cephalic version~   "
87544|NCT01911468|"~     The purpose of this study was to determine whether combined treatment with liraglutide and~     metformin is more effective than liraglutide or metformin as monotherapy in the treatment of~     obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders~     regarding weight reduction on metformin monotherapy. We anticipated greater changes in body~     weight in patients on combined treatment than in those on monotherapy with liraglutide or~     metformin.~   "
87545|NCT01911455|"~     In this research study we want to understand the effectiveness of a drug treatment,~     acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment)~     associated with Fragile X Syndrome (FXS).~   "
87546|NCT01911442|"~     This is a randomized, double-blind, placebo-controlled study designed to evaluate the~     efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks~     compared with placebo in pediatric and adolescent subjects with irritability associated with~     autistic disorder who reside in the community setting.~   "
87547|NCT01911429|"~     Efficacy and Safety study of Lurasidone in pediatric patients.~   "
87548|NCT01911416|"~     Pancreatic cancer is considered a rare form of cancer with about 277,000 new cases diagnosed~     in 2008 world-wide, which is about 2.5% of all forms of cancer. However, pancreatic cancer~     is more common in developed countries where the rate of this tumor is on the rise compared~     to other types of cancer.~      LDE225 is a new medicine that blocks a cellular pathway (called Hedgehog pathway) that is~     thought to be changed in some patients with pancreatic cancer. LDE225 is a medicine which~     has not been approved by the FDA for the treatment of people with your medical condition.~     The medicine being tested in this study is currently not on the market (available to buy)~     in any country.~      The purpose of this study is to see the effect LDE225 has on blood and tumors.~   "
87549|NCT01911403|"~     Clinical study in patients undergoing any intervention requiring vascular access to the~     femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control~     the vascular access.~      It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.~   "
87872|NCT01907165|"~     This clinical trial studies disulfiram in treating patients with glioblastoma multiforme~     (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of~     the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.~   "
87550|NCT01911390|"~     A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility~     study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is~     a helpful dietary recommendation to reduce total cholesterol levels in children with~     identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption~     of dry bean powder and rice bran merit additional investigation to study feasibility and~     acceptability in children and how they influence their lipid levels or obesity.~   "
87551|NCT01911377|"~     This study will examine the efficacy of Botulinum Toxin Type A (Botox) in treating~     Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.~      Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system,~     and is common in spinal cord injury patients or people with multiple sclerosis.~      Allodynia is a type of neuropathic pain caused by something that normally would not cause~     pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.~      Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord~     injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and~     has recently been studied as a treatment for neuropathic pain.~      We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type~     neuropathic pain.~      24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 controls~     receiving placebo.~   "
87552|NCT01911364|"~     The purpose of this study is to determine the triple combination of beclometasone~     dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of~     severe COPD patients (chronic obstructive pulmonary disease)~   "
87553|NCT01911351|"~     Title:~      High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety~     during pediatric minor procedures.~      Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in~     addition to standard management increases the comfort level in pediatric patients undergoing~     minor procedures compared to standard management alone.~   "
87554|NCT01911338|"~     -  Background Context: no studies have been identified to analyse the effect of real time~          feedback (using inertial sensors) on physiotherapy students learning the art of~          posterior-anterior thoracic manipulation (PATM).~        -  Purpose: to study the effect caused by real-time feedback on the learning process for~          PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant~          differences will exist in the execution parameters of manipulation among students~          receiving real-time feedback versus those who do not.~        -  Study Design/Setting: longitudinal, pre-post intervention.~        -  Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly~          into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30)~          (group with real-time feedback).~        -  Outcome Measures: time, displacement and velocity and improvement (only between groups)~          to reach maximum peak, to reach minimum peak from maximum peak, total manipulation~          time.~        -  Methods: two groups of physiotherapy students learned PATM, one using a traditional~          method and the other using real-time feedback (inertial sensor). Measures were obtained~          pre- and post-intervention. Intragroup pre- and post-intervention and intergroup~          post-intervention scores were calculated. An analysis of the measures' stability was~          developed through an ICC (1,2).~        -  Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant~          differences were found in all variables analysed (intra- and inter-group) in favour of~          G2.~        -  Conclusions: the learning process for posterior-anterior thoracic manipulation is~          facilitated when the student receives real-time feedback.~   "
87555|NCT01911325|"~     This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized~     double-blinded placebo controlled Phase II part.~      The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose~     (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be~     investigated in a Phase II randomized trial in patients with advanced or metastatic squamous~     NSCLC.~   "
87556|NCT01911312|"~     An investigation into the relative effectiveness of thermal-aided muscle stimulation vs.~     body temperature muscle stimulation for eliciting muscle contraction in the quadriceps~   "
87557|NCT01911299|"~     The purpose of this study is to determine whether choline supplementation can improve~     cognitive functioning of children with prenatal alcohol exposure.~   "
87558|NCT01911286|"~     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem~     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous~     breathing is established the apnea test (according to the American Academy of Neurology's~     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and~     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some~     data suggest modifying the apnea test : replace the ventilator switching off with continuous~     positive airway pressure (CPAP) use. These studies showed that this alternative method~     (CPAP) increased the level of lung harvest but they were not sufficient because these~     studies were monocentric with little patients,. That why the aim of the present study is to~     compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster~     trial; each center will use the method of apnea test which it uses usually.~   "
87559|NCT01911273|"~     The primary purpose of the study is to explore whether treatment with PF-03446962 and best~     supportive care is better than placebo plus best supportive care in prolonging survival of~     patients affected by recurrent liver cancer. In addition, the study will explore if adding~     PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are~     patients' characteristics (biomarkers) that may predict response to PF-03446962, and if~     PF-03446962 has any effect on the patients' quality of life.~   "
87560|NCT01911260|"~     The purpose of this study is to measure the effect of weekly zinc supplementation on~     schoolchildren with growth deficit or normal stature.~   "
87568|NCT01911156|"~     This is a prospective randomized, open-label, phase IV clinical trial to learn the effects,~     good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72~     weeks in participants with chronic hepatitis B infection whose immune system is controlling~     the amount of virus levels in the blood for at least 12 months of NA therapy.~      About 66 adult men and women will participate in this study from University Health Network~     which includes the Toronto Western Hospital for about 72 weeks.~   "
87561|NCT01911247|"~     The overall goal of this proposal is to investigate the potential benefit of metformin as a~     novel therapy for the treatment of endometrial cancer. Investigators will evaluate the~     effect of short-term metformin treatment on the endometrium of obese women with endometrial~     cancer by comparing each patient's endometrial biopsy before treatment with metformin to~     their post-treatment hysterectomy specimen.~      Participants: Obese women who are to undergo surgical staging for endometrial cancer will~     also receive short-term treatment (1-4 weeks) with metformin that will continue until the~     day prior to surgical staging.~      The effect of metformin on proliferation, apoptosis and downstream signaling pathways will~     be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy~     specimens. Tissue microarrays will be constructed and immunohistochemstry performed to~     evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by~     metformin, and these findings will be correlated with our in vitro preclinical studies.~     Fresh tissue will also be obtained, and Western immunoblotting will be used to assess~     expression of the phosphorylated forms of the downstream targets of metformin. The~     hypothesis is that treatment with metformin will result in a decrease in proliferative~     markers and an increase in markers of apoptosis in the endometrial cancer tumors. AMPK~     phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be~     seen in the post-treatment hysterectomy specimens. Metabolomic profiling will also be~     performed of tumors and associated biofluids (i.e. serum and urine) before and after~     treatment with metformin to identify potential biomarkers of response to this therapy.~   "
87562|NCT01911234|"~     The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II~     clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of~     clinical efficacy are promising.~      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in~     subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working~     anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be~     enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K~     will also be evaluated.~   "
87563|NCT01911221|"~     The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult~     population potentially at risk for meningococcal disease (e.g. lab workers).~   "
87564|NCT01911208|"~     The purpose of this study is to test a recruitment intervention to increase racial and~     ethnic diversity in clinical trials. The trial will be conducted in specialty care clinics.~     In RECRUIT minorities are those underrepresented in clinical trials and include:~        -  African Americans/ Blacks~        -  Asians~        -  Native Hawaiians/Other Pacific Islanders~        -  Hispanic/Latinos~        -  Native Americans/Alaskan Natives~   "
87565|NCT01911195|"~     Currently it is unknown how the human brain reorganizes its network organization to generate~     conscious experience and cognitive activity after a period of unconsciousness. Therefore,~     the purpose of this study is to assess how cognitive activity is reconstructed after general~     anesthesia. The investigators hypothesize that the brain's transition from unconsciousness~     to consciousness and full cognition is a complex process that occurs over an extended period~     of time. Specifically, the investigators hypothesize the following order of cognitive~     reconstitution: responsiveness to command, attention, complex scanning and visual tracking,~     working memory, and executive function.~      Volunteers will be healthy participants who are anesthetized with commonly used anesthetic~     drugs as well as a non-anesthetized group to control for circadian influences. A total of 60~     subjects will be recruited for this study. All subjects (male and female) will perform basic~     tests for cognition on a laptop computer at 30-minute intervals during this study. The~     testing battery to be administered was assembled to assess multiple cognitive functions in~     order to determine whether and how cognitive processes return to baseline function.~     Electroencephalogram (measuring brain electrical activity) data will be monitored and~     recorded during both anesthesia and cognitive testing, for subsequent analysis.~      This study is significant because it could lead to a better understanding of the neural~     correlates of human consciousness, as well as normal and abnormal conscious state~     transitions (including barriers to such transitions).~   "
87566|NCT01911182|"~     In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine~     is currently a worldwide therapy to reduce the number and severity of these apneas. This~     practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21~     months of age. However, caffeine is not 100% effective, and may have little effect on~     hypoxemia and bradycardia. Infants with intractable apneas unresponsive to caffeine~     treatment may require endotracheal intubation and mechanical ventilation. This procedure is~     invasive and has been associated with complications and increased risk for chronic lung~     disease and adverse neurodevelopmental outcome. Therefore, an alternative treatment modality~     would be preferable if it would prevent the infants from requiring endotracheal intubation.~     The investigators have been testing the overall hypothesis that small concentrations of~     inhaled CO2 (~1%) are effective in treating apnea of prematurity. The investigators have~     completed three studies in preterm infants showing that inhalation of low concentration of~     CO2, in infants not on caffeine, regularize breathing and decrease apneas significantly. The~     effects of inhalation of CO2 in infants already on caffeine, are unknown. The hypothesis to~     be tested is that inhalation of low concentration CO2 (1%) will significantly reduce apnea~     in infants treated with caffeine. The investigators have three specific aims in this~     proposal. 1) the investigators want to know if the apnea rate (number of apneas of ≥5~     seconds/hour) is decreased with CO2 inhalation in preterm infants already on caffeine for~     the treatment of apnea of prematurity; 2) the investigators want to know whether inhalation~     of CO2 can make breathing more regular with less apneic time and whether it decreases~     prolonged apneas (>20 seconds) in infants already on caffeine for the treatment of apnea of~     prematurity; 3) the investigators want to assess the effect of inhalation of low~     concentration of CO2 on the regional oxygen saturation of the brain measured by~     near-infrared spectroscopy (NIRS) during apneas. This is to see whether CO2, by protecting~     cerebral blood flow, minimizes the decrease in cerebral oxygenation during apneas. This~     study entails a new and possibly more physiological method of treating apneas of prematurity~     that can be added to the present treatment of caffeine. These two treatments together, could~     minimize the number and severity of apneas and possibly decrease the need for mechanical~     ventilation in preterm infants.~   "
87567|NCT01911169|"~     Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of~     endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients.~     The investigators will enroll vitamin D deficient SLE patients and randomize them to receive~     either 400 IU or 5,000 IU of cholecalciferol (D3) daily and measure change in FMD as a~     measure of EC function at baseline and after 16 weeks of repletion.~      Determine mechanisms by which vitamin D repletion may improve endothelial function in~     vitamin D deficient SLE patients and in vitro.~      Determine effect of oral D3 repletion on the Type I interferon signature in WISH and ECs~     cultured with pre and post plasma from D3 treated lupus patients.~      Determine effect of D3 repletion on the number of circulating apoptotic and non-apoptotic EC~     and EPC ex vivo.~      Determine effect of exogenous 1,25(OH)D on IFN gene signature in WISH and ECs stimulated by~     pretreatment SLE plasma in vitro.~      Determine the effects of exogenous 1,25(OH)D on the phenotype of ECs cultured with~     pretreatment lupus plasma.~      This study is designed to efficiently test our hypothesis and begin to define~     interferon-dependent pathways through which vitamin D repletion can restore clinical and in~     vitro endothelial function.~   "
87569|NCT01911143|"~     This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic~     (IVD) assay that will include samples that were previously collected from febrile pediatric~     patients. The investigated assay measures the levels of a few host-related, blood-based,~     bio-markers that will be integrated into a single score. Based on this score, each patient~     will be classified into one of three categories: (i) bacterial immune response, (ii) viral~     immune response, and (iii) marginal immune response. The assay prediction and the patient~     diagnosis will than be unveiled and compared to determine their level of concordance.~   "
87570|NCT01911130|"~     A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS)~     was developed to precisely and conveniently measure static limb strength in patients with~     ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes~     measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC)~     in a prospective, longitudinal study. All three outcomes measures will be performed on 100~     subjects collected preferably at bi-monthly clinic visits during the study period.~   "
87571|NCT01911117|"~     In one previous study, esCCO was compared with continuous thermodilution CO (TDCO),~     measurements in 36 postoperative cardiac surgery patients, showing a bias (mean difference)~     of -0.06 and a precision (1 SD) of 0.82 L/min. In addition, esCCO was compared with~     intermittent bolus TDCO, showing a correlation coefficient of 0.82 (P < 0.001, n = 24), a~     bias of -0.63, and a precision of 1.01 L/min (n = 119). The results of clinical use of esCCO~     suggest that its measurement accuracy is comparable to the thermodilution method in general~     population. However, no any intraoperative comparison for cardiac surgery patients was~     reported before. This study is designed for the accuracy in the patients undergoing cardiac~     surgery.~      Specific aims:~        1. To investigate the correlation of esCCO and the traditional CO measurement in cardiac~          surgical patients.~        2. To investigate the intraoperative t accuracy of time point between ecCCO and~          traditional CO measurement for patients undergoing bypass cardiac surgery.~   "
87572|NCT01911104|"~     The purpose of this study is to collect data to help researchers identify factors that~     prevent certain individuals from receiving the beneficial effects of exercise.~   "
87573|NCT01911091|"~     The purpose of this study is to collect data to help researchers identify factors, such as~     certain proteins or genetic codes, that are secreted from muscle that are associated with~     the beneficial effects of exercise.~   "
87574|NCT01911078|"~     The purpose of this clinical investigation is to determine the effects of renal sympathetic~     denervation on insulin resistance and muscle sympathetic nerve activity in patients with~     metabolic syndrome.~   "
87575|NCT01911065|"~     With increasing age, immune responses to vaccination begin to decline. A decrease in~     vaccination success rates is already evident in the 6th and 7th decade of life. With the~     changing demographics of the US population, this decline in immune function is a major~     health concern.~      The study of the immune responses to the naturally-acquired chicken pox virus and to the~     shingles vaccine will provide an important opportunity to learn more about the aging immune~     system and may lead to an improvement in vaccination strategies and identification of ways~     to improve vaccine responses in older individuals~   "
87576|NCT01911052|"~     Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates~     of missing important lesions, increased patient discomfort, higher risk of complications,~     prolonged procedure time and increased health-care cost. Recent study reported that~     Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the~     quality of bowel preparation and polyp detection rate. However, there is no study to compare~     the effect of telephone with short message system (SMS) based re-education on the quality of~     bowel preparation in health screened population. Our goal is to improve the quality of bowel~     preparation with telephone or SMS based re-education for outpatients undergoing screening~     colonoscopies. The investigators hypothesise that efforts to improve education and maximise~     patient compliance during the preparatory period will enhance the efficacy of bowel~     preparation.~   "
87577|NCT01911039|"~     Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or~     hematopoietic cell transplant from another person (allogeneic transplant). This study will~     determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor~     regulatory T cells and whether their cGVHD responds to the infusion.~   "
87578|NCT01911026|"~     Effective bowel preparation is important for examination of the entire colon adequately and~     for identifying colonic lesions during colonoscopy. However, it is well known that bowel~     preparation of inpatients is much poorer than that of outpatients. Our goal is to improve~     bowel preparations with reinforcement of nurse education that explains the steps required~     for bowel preparation for inpatients undergoing colonoscopies. The education will focus on~     explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the~     pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the~     control group will receive the standard written bowel preparation instructions, while~     patients in the intervention group will receive standard written instructions plus a~     explanation from reinforcement-educated nurse. The investigators hypothesize that patients~     received a explanation from reinforcement-educated nurses will lead to improved patient~     compliance and a better bowel preparation. In addition, the investigators hypothesize that a~     better quality bowel preparation will improve detection of colonic polyps and patients'~     satisfaction for colonoscopy.~   "
87579|NCT01911013|"~     The purpose of this study is firstly to determine the efficacy of cervical plate for~     anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the~     determining factors for surgical outcomes.~   "
87614|NCT01910558|"~     Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a~     cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to~     selectively reduce saturated fat and calories which will have a medically beneficial effect~     on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α-~     cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal~     fat on a high saturated fat diet compared to the same diet supplemented with a digestible~     carbohydrate control~   "
87873|NCT01907152|"~     The objective of this study is to investigate the acceptance, intake, and compliance of~     protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real~     life settings (short term; hospital, and longer term; rehabilitation home).~   "
87580|NCT01911000|"~     The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most~     significant prognostic factors for poor prognosis, without treatment, their survival is less~     than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control~     and about 10 months survival duration. Despite the standard treatment of the HCC combined~     with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an~     option in those patients. Investigators previously reported the retrospective study that the~     scheduled interval TACE followed by RT for HCC combined with PVTT and 60% of the patients~     showed objective response without significant elevation of complication. It is reported that~     hyperthermia considered as the most valuable radiosensitizer in cancer treatment,~     theoretically. Based on those studies, we start this prospective study to evaluate the~     objective response and adverse event in the combination treatment of RT and hyperthermia~     after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined~     with PVTT.~   "
87581|NCT01910987|"~     The objective of this study is to describe the effect of optimized retreatment with~     bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib,~     versus standard retreatment with bortezomib in combination with dexamethasone on progression~     free survival (PFS).~   "
87582|NCT01910974|"~     safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system~     is a new water jet system which allows to perform Endoscopic submucosal dissection with a~     bifunctional catheter (injection and cutting).~   "
87583|NCT01910961|"~     To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality,~     hospitalization costs and quality of life in patients undergoing open infrarenal abdominal~     aortic aneurysm (AAA) repair.~   "
87584|NCT01910948|"~     To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated~     fatty acids in gastric cancer surgery, the effects of postoperative recovery, the~     improvement of nutritional status, incidence rate of related complications, and whether it~     can reduce the average postoperative hospitalization days.~   "
87585|NCT01910935|"~     The purpose of this study is to evaluate the effectiveness of a program to increase the~     physical activity of hypertensive patients using medical services and sports facilities of~     the Mexican Social Security Institute. The primary hypothesis to be proven is: The~     intervention will increase the proportion of hypertensive patients complying the physical~     activity minimum at week to get benefits on health in 20%, compare to patients in control~     group.~   "
87586|NCT01910922|"~     The aim of this study is to understand the formation of food preferences from an early age.~   "
87587|NCT01910909|"~     1. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of~     cancer death globally. It is also the second cause of cancer mortality in Korea, despite the~     incidence of HCC was fifth. The most important cause of this discrepancy is connected with~     the fact that the significant portion of the HCC is detected as unresectable status.~      1.2. Standard treatment of the HCC At the point of HCC diagnosis, only 30% of the patients~     could receive standard curative treatment, like resection, liver transplantation, and~     radiofrequency ablation (RFA). Transcatheter arterial chemoembolization (TACE) has been~     shown in randomized trials to improve survival compared with symptomatic therapy alone, in~     the patients without macrovascular involvement, extrahepatic disease and tumor related~     symptoms. However, in the recent review of TACE, TACE might be contraindicate or not~     recommended in the patients who showed vascular tumor invasion, more than 10 cm size, poor~     portal blood flow and/or repeated poor response.~      Recently, Sorafenib, which is one of the target agents, showed survival advantage on~     unresectable HCC patients in two randomized study. In those study, sorafenib improved~     approximately three month overall survival increment, however, the median survival duration~     was only 10.7 months in experiment group (received sorafenib), and even 6.5 months in~     Asian-Pacific trial. Additionally, the possibility that sorafenib effect could be reduced in~     the patients had hepatitis B virus (HBV) was suggested in the subgroup analysis.~      1.3 Radiation therapy (RT) for the HCC The use of RT in HCC is increased with the radiation~     technological advances. In the unresectable patients, RT showed 50 to 60% response rate with~     the dose response relationship. Recently, stereotactic body radiation therapy (SBRT) showed~     excellent local control and comparable survival rate in thoracic tumor. In the HCC, SBRT~     also showed 75 to 100% local control rate without significant elevation of the toxicities.~     One study reported that 24 to 54 Gy SBRT achieved 87% 1year local control and 17 months~     overall survival. The standard treatment of unresectable HCC is sorafenib, but Korean Liver~     Cancer Study Group (KLCSG) recommend RT as an option in localized unresectable HCC.~     Furthermore, Radiation Therapy Oncology Group (RTOG) started randomized trial to confirm the~     effect of SBRT in unresectable HCC (RTOG 1112).~      Investigators previously reported the retrospective result that the higher dose SBRT~     achieved 2 year overall survival 87.9% and local control 85% in the patient who showed less~     than 5 cm solitary HCC without portal vein involvement.~      Based on those studies, we start this prospective study to evaluate the effectiveness and~     adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without~     extrahepatic lesion and vascular involvement.~   "
87588|NCT01910896|"~     To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of~     post dermatological surgery scars and its safety over 12 to 24 weeks.~   "
87589|NCT01910883|"~     This is the first time finafloxacin was administered to humans intravenously. The principal~     aim of this study was to obtain safety and tolerability data when finafloxacin was~     administered intravenously as single and multiple doses to healthy subjects.~   "
87590|NCT01910870|"~     To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.~   "
87591|NCT01910857|"~     -  The overall hypothesis for the project is that racial health disparities will be~          reduced by improving hypertension control in African Americans.~        -  This will be accomplished through the development, implementation, and evaluation of a~          cost-effective hypertension control strategy based on the involvement of a community~          health worker.~   "
87592|NCT01910844|"~     Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients~     with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and~     Taxanes.~   "
87593|NCT01910831|"~     To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in~     improving the appearance of bruising and reducing the appearance of photoaging of the~     forearms and hands in mature skin. Assessments will be made through ongoing objective~     measurements and clinical ratings.~      To confirm the safety (local tolerance) of DerMend Moisturizing Bruise Formula.~   "
87615|NCT01910545|"~     The purpose of this study is to test the safety and tolerability of an investigational drug~     called OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which~     demonstrated antitumor properties in laboratory tests. It is being developed as an~     anti-cancer drug. In this first-in-human study OTS167 will be administered to patients with~     solid tumors which have not responded to treatment.~   "
87616|NCT01910532|"~     This is a single-arm, open label safety and dose titration study evaluating the use of~     Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial~     Pressure Monitoring device.~   "
87594|NCT01910818|"~     Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic~     process in the skin which can lead to increased risk of malignancy, poor wound healing, pain~     and limitation of movement, and permanent loss of skin appendages with~     hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and~     quality of life issues. Advances in laser therapy has led to the use of fractional laser~     treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading~     to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test~     the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling~     in patients affected by chronic radiation injury. Understanding and correcting this~     underlying fibrotic process can help restore normal skin functions in patients affected with~     chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology~     such as scleroderma, morphea, or nephrogenic systemic fibrosis.~   "
87595|NCT01910805|"~     Women with a history of gestational diabetes (GDM) have a substantially increased risk of~     developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2~     diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of~     developing type 2 diabetes among women with a history of GDM may be particularly important~     to altering behavior changes associated with reducing risk. Certain populations have lower~     perceived risk of developing type 2 diabetes, despite having a higher prevalence of the~     disease. Specifically, African-Americans have a lower perceived risk of developing type 2~     diabetes compared to whites, despite their more than doubled risk of developing the disease.~     Improvement in awareness of diabetes risk among African-American women at high-risk of~     developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of~     this disease among this group.~      As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether~     a postpartum diabetes education intervention, incorporating nutrition, exercise, and~     diabetes risk assessment can improve diabetes risk awareness, diet, and physical activity~     levels at 1-year post-pregnancy among African-American women with a recent history of~     gestational diabetes.~      We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class~     will:~        1. Improve diabetes awareness as measured using the Risk Perception for Developing~          Diabetes among women in the intervention group compared to women in the control group~          when measuring at 3-months postpartum compared to 12-months postpartum~        2. Improve dietary habits and physical activity levels in the intervention group compared~          to the control group when measuring at 3-months postpartum compared to 12-months~          postpartum~   "
87596|NCT01910792|"~     Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes~     including cystic fibrosis, among others, or who have undergone gastric bypass have increased~     incidence of vitamin D deficiency relative to the general population. Given that vitamin D~     is fat soluble and absorbed in the proximal small intestine, it has been documented that~     vitamin D deficiency in people with a fat malabsorption syndrome is due to decreased~     absorption of vitamin D.~      The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources~     will negligibly raise blood vitamin D levels in these patients, and oral vitamin D~     supplementation may have limited efficacy due to malabsorption. A variety of UV light~     sources have been developed and sold as in-home tanning devices and to produce vitamin D in~     reptiles. The efficacy of correcting vitamin D deficiency by the skin exposure to an~     artificial source of UVB radiation in patients with fat malabsorption syndromes (Crohn's~     disease, ulcerative colitis, or cystic fibrosis) or after gastric bypass surgery has not~     been studied. The investigators have conducted a pilot study in healthy adults that~     demonstrated that exposure to the lamp raised the blood level of 25-hydroxyvitamin D with no~     side effects. The main purpose of this study is to evaluate the effect of the FDA approved~     artificial source of ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D~     status in patients with fat malabsorption syndromes and patients who have undergone~     roux-en-Y gastric bypass surgery.~   "
87597|NCT01910779|"~     Use of higher energy doses (120-150 J) may not offer additional benefits and higher success~     rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial~     fibrillation cardioversion. In this prospective open-label randomized trial consecutive~     patients with AF and candidate to AF electrical cardioversion will be randomized to receive~     100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each~     group to anterolateral or postero-anteriore placement of defibrillator electrodes.~   "
87598|NCT01910766|"~     Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10~     (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic~     ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university~     hospital and private practice setting. One hundred ten infertile women with PCOS resistant~     to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day~     alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.~      Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness,~     pregnancy rate (PR) and miscarriage rate.~   "
87599|NCT01910753|"~     The purpose of this study is to examine the feasibility of resistance training and physical~     functioning associated with nutrition therapeutic education in head and neck cancer~     patients, during their treatment (chemotherapy with or without radiotherapy).~   "
87600|NCT01910740|"~     The main aim of this study is to investigate whether increasing the amount of physical~     activity in frail older people during hospital based rehabilitation is associated with~     better mobility outcomes compared to usual care. A second aim is to investigate whether this~     physical activity intervention is associated with improvements in health related quality of~     life. Finally we plan to investigate whether increasing the amount of physical activity~     during rehabilitation is cost effective, measured from a health system perspective, compared~     with usual care.~      Older people receiving inpatient rehabilitation will be randomly assigned to an intervention~     group, who will receive extra physical activity on weekdays and weekends or a control group,~     who will receive additional activities based on social interaction. The activity sessions~     will be individualized to the particular participant. Both groups of people will be assessed~     at baseline, discharge from hospital and at 6 months following discharge. The intervention~     group will be provided with one or two extra sessions on weekdays and two extra sessions on~     weekends for the duration of their rehabilitation stay. To account for the extra~     physiotherapy time that the intervention group receives, the people in the control group~     will spend the same amount of time performing other activities, such as cards, board games~     or reading, whilst seated. To ensure the safety of the participants in this study, each~     physical activity session will be supervised by either a physiotherapist or allied health~     assistant.~      Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the~     amount of physical activity in frail older people during rehabilitation will lead to more~     optimal mobility at discharge, as measured by gait speed.~      Secondary hypotheses are that, compared with usual care, increasing the amount of physical~     activity during rehabilitation will:~      Hypothesis 2: lead to significantly greater improvements in mobility and function both at~     discharge and six months following discharge.~      Hypothesis 3: lead to better quality of life six months following hospital discharge,~     measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale~     (EQ-VAS).~      Hypothesis 4: be cost effective compared to usual care~   "
87601|NCT01910727|"~     The objective of the Together on Diabetes study is to test the efficacy of a pilot~     intervention to improve the prevention and management of type 2 diabetes among American~     Indian youth.~      The primary aim of this study is to determine the impact of the Together on Diabetes pilot~     intervention on youth diabetes risk behaviors, including:~        -  Improvement in youth dietary intake, with a specific focus on reducing the percent of~          total calories from fat.~        -  Improvement in youth physical activity, with a specific focus on increasing the number~          of minutes of physical activity each week.~      An additional primary aim of the study is to determine the feasibility and acceptability of~     the pilot intervention and evaluation, including program adherence and program satisfaction.~      The secondary aim of this study is to determine the feasibility of collecting data to~     determine program impact on a number of physiological measures.~   "
87602|NCT01910714|"~     The investigators seek to adapt, implement and evaluate a randomized controlled trial of an~     evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk,~     targeting Apache adolescents. Specific study objectives include:~        1. To perform formative research through focus groups and individual interviews on~          attitudes, practices and intervention preferences among Apache adolescents and~          community stakeholders.~        2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the~          formative research, components of Protection Motivation Theory, and input from a~          community advisory board.~        3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized~          intervention trial measuring behavior change at 6- and 12- months follow-up.~        4. To determine the feasibility of gathering biological specimens via self-administered~          swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and~          future studies.~   "
87603|NCT01910701|"~     The aim of the proposed research is to implement and evaluate a follow-up study of the~     impact of the Family Spirit family strengthening program among a high-risk sample of Apache~     mothers and their children. The Family Spirit intervention is a 52-session home-visiting~     curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks~     gestation through the child's first 3 years of life. In a series of pilot studies and a~     recently completed randomized controlled trial, the Family Spirit intervention has been~     found to positively impact several maternal, parenting and child outcomes up through three~     years postpartum. In the proposed study, the investigators will implement the Family Spirit~     intervention to young mothers (12-20 years at conception), with revisions to several~     assessment measures and to the curriculum such that the substance abuse prevention~     curriculum modules will be taught earlier than in the original study.~   "
87604|NCT01910688|"~     The present study will assess the feasibility of using endoscopic radiofrequency ablation~     (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and~     decreased compliance after a failed Roux-en-Y gastric bypass.~   "
87605|NCT01910675|"~     The purpose of the study is to find out if the regimen of prothrombin complex concentrate~     (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP)~     (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum~     haemorrhage (PPH). The original protocol included the use of HES and the recruitment of~     patients was postponed while waiting the final decision by EMA. All HES solutions were~     abandoned at our institution in September and an amendment was made to change the protocol.~     HES solution are replaced by the use of hyperoncotic (20%) albumin.~   "
87606|NCT01910662|"~     This is an exploratory study to develop methodologies for the assessment of T-cell mediated~     therapies via skin immune challenges studies in healthy volunteers. The study will~     investigate what is the most appropriate; skin challenge agent, time and methodology to~     sample and characterise T-cells in the delayed type hypersensitivity (DTH) skin reaction.~     The skin challenge agents to be used in this study will be the neoantigen Keyhole Limpet~     Hemocyanin (KLH) and recall antigen Tuberculin Purified Protein Derivative (PPD). Part A of~     the study will assess an intradermal (ID) KLH challenge in three subjects to assess if the~     immune response to KLH is initiated by the innate or adaptive immune system. Each subject~     will receive one ID dose of 0.1 milligram (mg) KLH and will be assessed for a skin~     inflammatory response. Part B of the study will assess repeat ID challenges 28 days apart;~     the objective will be to characterise the T-cell response to each challenge and the kinetics~     of that response.~      For Cohorts 1A and 1B, 16 subjects will receive an initial subcutaneous (SC) 5 mg dose of~     KLH. Fifteen days later the subjects will receive 0.1 mg ID KLH dose and the response will~     then be assessed 48 and 120 hours after the initial challenge. The ID KLH challenge will~     then be repeated 28 days later and the response will be assessed at 48 hours (Cohort 1A, 8~     subjects) and at 120 hours (Cohort 1B, 8 subjects) post challenge. For Cohort 2, a repeat~     challenge of either 2 tuberculin Unit (TU) or 10 TU ID PPD will be administered 28 days~     apart, to 8 subjects. The first challenge response will be assessed 48 and 120 hours post~     challenge. The second challenge will be administered 28 days after the first and will be~     assessed at the same timepoints. The repeat challenge 28 days later will allow an~     intra-subject analysis and will determine if a subject can be used as their own control.~     Part C of the study will assess repeat ID challenges of PPD and PBS; the objective will be~     to characterise the T-cell response to each challenge and the kinetics of that response. For~     Cohort 1, 6 subjects will receive a 0.1ml ID dose of PBS and another dose 24 hours later.~     Each challenge will be assessed 48 hours post challenge. Approximately 2 subjects will have~     an assessment of their normal skin as a control. For Cohort 2, a repeat challenge of either~     2TU or 10TU ID PPD will be administered 28 days apart, to 6 subjects. The first challenge~     response will be assessed 48 post challenge. The second challenge will be administered 28~     days after the 1st and will be assessed at the same timepoint. The repeat challenge 28 days~     later will allow an intra-subject analysis and will determine if a subject can be used as~     their own control.~      The total duration of this study for Part A is 14-18 days plus up to 30 days screening. The~     total duration of this study for Cohort 1A is 56-60 days plus up to 30 days screening. The~     total duration of this study for Cohort 1B is 59-63 days plus up to 30 days screening. The~     total duration of this study for Cohort 2 if 2TU is used is 45-49 days plus up to 30 day~     screening. The total duration of this study for Cohort 2 if 10TU is used is 48-51 days plus~     up to 30 days screening. The total duration of this study for Part C Cohort 1 is 15-19 days~     plus up to 30 day screening. The total duration of this study for Cohort 2 if 2TU is used is~     42-46 days plus up to 30 day screening. The total duration of this study for Cohort 2 if~     10TU is used is 45-49 days plus up to 30 days screening.~   "
87607|NCT01910649|"~     The purpose of the extension phase of this study is to determine whether Drisapersen is~     effective in the treatment of boys with Duchenne muscular dystrophy resulting from a~     mutation thought to be corrected by exon 51 skipping.~   "
87608|NCT01910636|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir~     (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C~     virus (HCV) infection.~   "
87609|NCT01910623|"~     This study will focus on acute promyelocytic leukemia patients who have been diagnosed more~     than 5 years ago and their present quality of life.~      The possible late effects of cancer treatment can include several issues and, thus, there~     has been an increasing interest worldwide in studying the long-term impact of these in~     patients' life.~   "
87610|NCT01910610|"~     STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with~     metastatic colorectal cancer.~   "
87611|NCT01910597|"~     Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast~     which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun~     Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon~     pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune~     function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular~     carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to~     see the safety and anti-cancer property of SBG in patients with advanced cancer whom no~     available therapy can be offered.~   "
87612|NCT01910584|"~     The aim of this study is to investigate the influence on the quality of life and sexual~     function before, 6 month and one year after Novasure Endometrial Ablation in the treatment~     of Menorrhagia.~   "
87613|NCT01910571|"~     -  This is a single centre, phase I, randomized, double-blind, placebo-controlled,~          crossover, dose escalating study of P7435 using single and multiple doses, to be~          conducted in healthy male and female (Non child bearing) subjects having BMI between 19~          to 40 kg/m2.~        -  The study will be conducted in 2 parts as follows: Part A will consist of the Single~          Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD)~          study.~   "
87655|NCT01910012|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has~     been used to treat patients that have cancers that require arginine. In this study, the~     investigators will evaluate the response rate, as determined by the revised International~     Working Group recommendations.~   "
87617|NCT01910519|"~     This study will compare the different immune responses to Influenza A (H5N1) Virus~     Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus~     Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect~     against flu caused by the A/H5N1 bird flu virus in Europe but none of the vaccines to be~     used in the study are approved for use in the United States. The results of this study will~     help researchers learn about better ways to vaccinate people against the H5N1 flu.~   "
87618|NCT01910506|"~     This study will determine the characteristics of absorption, metabolism, and excretion (AME)~     of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries~     (µCi) of [14 C]RDEA3170 in healthy adult male subjects.~   "
87619|NCT01910493|"~     Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to~     improve health outcomes. However, robust data on the efficacy of SMS on health seeking~     behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study~     aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy~     (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in~     Mozambique.~   "
87620|NCT01910480|"~     The purposes of this study are to: learn about the safety of the study drug (NBI-98854);~     learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics~     (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a~     drug) of the investigational study drug after taking it alone and with ketoconazole.~     Ketoconazole is known to affect the PK of many drugs and is studied to more safely prescribe~     medications.~   "
87621|NCT01910467|"~     Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number~     of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near~     infrared spectroscopy in combination with predefined interventions and secondly to explore~     the potential impact on cerebral injury and mortality.~      Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation~     ratio investigators will reduce hypotensive episodes and use of catecholamines which will~     reduce cerebral injury and mortality.~      Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300)~     will be measured for 24h starting <6 hours postpartum. When cTOI/pTOI ratio increases >5%~     within a 6h period, predefined interventions will be performed.~      Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines~     during the first 48h after birth. Secondary outcome parameters will be cerebral injury and~     mortality.~   "
87622|NCT01910454|"~     Stroke is the most serious disabling condition in the United States and the developed world.~     Novel stroke rehabilitation approaches, such as task-specific training, have shown promise~     in improving an individual's recovery in the rehabilitation setting; however, evidence~     suggests that these improvements are not generalized or transferred to the home, community,~     or work settings. Thus, these interventions usually do not impact overall health and~     participation outcomes. This research study seeks to improve task-specific training as a~     stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented~     strategies which have shown great promise as a way to address the limitations of~     task-specific training. The new treatment protocol is called Cognitive-Oriented Strategy~     Training Augmented Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR~     will result in more efficient functional skill acquisition, better long-term retention of~     skills learned, and generalization and transfer of skills learned to home, community, and~     work settings.~   "
87623|NCT01910441|"~     Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on~     glucose variability in T2DM patients.~   "
87624|NCT01910428|"~     Asparaginase (Asp) is used during the induction phase of ALL treatment for children and~     young adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years~     or older. The efficacy rate in older adult population is lower than for children or young~     adults. A recent review on outcomes in older adults with ALL pointed out that there were~     significantly more drug reductions, omissions or delays in the older group as compared to~     younger adults and that asparaginase was the drug most commonly omitted.~      The investigational product ERYASPASE is a dispersion for infusion of homologous red blood~     cells (RBC) encapsulating E. coli L-asparaginase.~      A previous European phase I/II clinical study in children and adults (<55 yo) at first~     relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating~     native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety~     profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard~     chemotherapy were compared to free native Asp. The global safety profile is also improved,~     reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a~     single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days,~     i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A~     reduction in the incidence and severity of the allergic reactions and coagulation disorders~     were observed with GRASPA® (Domenech 2011).~      A French phase II study designed to determine the maximum tolerated dose of GRASPA® in~     combination with a polychemotherapy regimen in ALL patients older than 55 yo at first~     diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the~     predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose~     was considered the optimal dose in this setting. A phase II/III trial in adult and children~     patients with relapsed ALL is currently ongoing.~      Based on these results, the combination of ERYASPASE with the CALGB chemotherapy regimen~     appears to be an attractive combination for the treatment of adults patients with ALL/LBL.~   "
87625|NCT01910415|"~     This study is designed to evaluate the effect of multiple doses of lumacaftor in combination~     with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart~     rate in healthy subjects.~   "
87626|NCT01910402|"~     This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC~     fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV)~     and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in~     HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety~     and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of~     subjects will be screened in order to ensure a total of approximately 474 subjects will be~     randomized (237 in each study arm)~   "
87627|NCT01910389|"~     This study is a multi-center, prospective, randomized, double blind, placebo-controlled~     clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA)~     Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left~     ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The~     purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil~     compared to placebo on the subjects' functional capacity / quality of life.~   "
87699|NCT01909440|"~     This randomized pilot clinical trial studies resistance training and protein supplementation~     in increasing lean body mass in patients with prostate cancer receiving androgen deprivation~     therapy. Resistance training and protein supplementation may help improve quality of life in~     patients with prostate cancer receiving androgen deprivation therapy.~   "
87628|NCT01910376|"~     Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the~     age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer~     mortality occurs in people older than 65 years. Moreover, due to the aging of the population~     in the Western world the number of elderly people is expected to increase and therefore the~     number of older cancer patients is expected to rise. Despite this rapid increase in cancer~     incidence and cancer-related mortality with age, our knowledge about ageing and cancer and~     about optimal treatment for older cancer patients is still far from adequate. Therefore, it~     is clear that cancer in the elderly is a major and increasing health problem. A key problem~     in geriatric oncology research is the important selection bias because very old/frail~     patients, are very rarely included in clinical trials.~      Changes in the patterns of health care delivery have shifted the care of the elderly from~     acute care settings to the community and long-term care facilities. As the European~     population ages, more and more people will become nursing home residents, many of whom will~     have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer~     is very common in elderly nursing home residents, it is poorly studied. This lack of~     information may impact on clinical decision making and the appropriateness of treatments~     offered and therefore collection of this information is needed.~      This project has two main objectives. The first objective is to report on demographics,~     referral patterns and motives for non-referral, anti-cancer treatments and outcome of~     patients in nursing homes with suspected or diagnosed active invasive cancer where a~     diagnostic or treatment decision has to be taken. The second objective is to develop better~     prognostic tools (for survival) including biological markers of ageing to help treatment~     decisions in the elderly.~   "
87629|NCT01910363|"~     To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for~     treating stroke patients with lower limb spasticity.~        -  we study the degree of spasticity in the ankle and knee joints, and walking speed in 30~          patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a~          blinded manner as for the patient, the physician, and the examiner.~        -  we also assess the safety of A2NTX and compare it to that of BOTOX.~   "
87630|NCT01910350|"~     1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and~     appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To~     determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and~     appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To~     measure functional cancer literacy over time at the individual and familial level and 4)~     Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and~     control-comparison groups.~   "
87631|NCT01910337|"~     The purpose of this study is to use heart rate variability as a monitor of cardiovascular~     safety during third molar surgeries, using the Polar heart rate-meter.~   "
87632|NCT01910324|"~     The fundamental objective of the proposed study is to develop and test an innovative~     two-stage, cross-systems family-based intervention for substance abusing juvenile offenders.~     The first stage of the experimental treatment is provided for youths in juvenile detention~     settings. Stage two of the intervention occurs after the offender is released to the~     community. Participants are randomized to one of two study conditions: the cross-systems~     family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2)~     Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention~     and we will also examine the effects of a family-based HIV/STD prevention module beyond the~     impact of a standard HIV/STD education intervention delivered in detention by including~     ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five~     aims of the proposed study. These aims relate to: 1) Intervention development and~     implementation; 2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4)~     Comparative benefit-costs; and 5) Systems-level impact~   "
87633|NCT01910311|"~     The purposes of this study are to look at what effect multiple doses of rifampicin have on a~     single dose of baricitinib and to look at the safety and tolerability of these drugs. Side~     effects will be documented. The study will last approximately 31 days from the first dose to~     the end of the study.~   "
87634|NCT01910298|"~     This is a prospective, multicenter, non-randomized, parallel design comparing a primary~     efficacy endpoint between subjects undergoing immediate post-mastectomy breast~     reconstruction with a breast implant and Strattice™ Reconstructive Tissue Matrix (TM) and~     subjects undergoing immediate, two-stage post-mastectomy breast reconstruction, where the~     initially placed expander will be exchanged for a breast implant only, without any type of~     reinforcement.~   "
87635|NCT01910285|"~     The main objective is the comparison of intubation conditions after anesthetic induction~     bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients~     undergoing surgery for tooth extraction.~      Intubation without myorelaxant with propofol and sufentanil is classic but less efficient~     than induction with curare on achieving perfect intubation conditions. The use of a protocol~     without curare is sometimes justified for short gestures or when you want to avoid allergia.~     Remifentanil often provides excellent intubation conditions without myorelaxant. However,~     remifentanil was never compared to sufentanil in terms of intubating conditions without~     muscle relaxant.~   "
87636|NCT01910272|"~     Invasive cardiac procedures involve procedural guidance with x-rays in the form of~     fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to~     staff involved in these procedures. Lead shields are placed between the operators (on their~     left side) and the x-ray source to limit exposure. However as the operator requires direct~     access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns,~     thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and~     eyes respectively, but their thickness is limited by their relatively heavy weight.~     Nevertheless this leaves the brain exposed. Further, interest in the risk of brain cancer in~     invasive cardiologists has re-emerged after a recent report of left-sided brain cancer in~     primary operators of interventional cardiology procedures. Lead caps have been tested in the~     past but the relatively heavyweight of lead has limited wide-spread implementation. The cap~     typically worn during invasive procedures is lightweight, has no significant x-ray~     absorption properties, and is worn to help maintain a sterile environment. A novel,~     lead-free cap, composed mainly of barium sulfate and bismuth oxide, has been developed that~     has been shown to absorb x-rays while being significantly lighter than lead. The~     investigators propose using multiple x-ray detectors to test exposure differences between~     the primary and secondary operators, the left side and right side of the head, and~     absorption via a lead-free cap.~   "
87700|NCT01909427|"~     The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants~     with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.~   "
87701|NCT01909414|"~     The purpose of this study is to evaluate the safety of two HIV vaccines in HIV-1-infected~     young adults who are taking anti-HIV medications and have very low virus levels. This study~     will also look at how the immune system responds to the vaccines.~   "
87637|NCT01910259|"~     Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects~     approximately 100,000 people in the UK. Many patients with MS experience two phases of~     disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called~     secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the~     insulation (called myelin) that surrounds the nerves. Early MS is often characterised by~     periods of attacks interspersed with periods of remission with no or low disease~     symptoms. Late or progressive MS, which affects the majority of patients and typically~     emerges after 10-15 years of disease, results from actual nerve death (also called~     neurodegeneration). The progressive stage of disease results not in individual attacks but~     slow, cumulative and irreversible disability affecting walking, balance, vision, cognition,~     pain control, bladder and bowel function. Critically, and unlike early disease, there is no~     proven treatment for the late stage of MS. This is therefore an urgent and major unmet~     health need. MS-SMART directly addresses this need and will evaluate in this clinical trial~     three drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS,~     and in particular in SPMS. The trial is randomised and blinded. Randomisation means patients~     can get any one of the three active drugs or the inactive placebo/dummy; blinded means that~     neither patients nor the doctors will know which drug or placebo patients are receiving.~     Randomisation and blinding are standard approaches in clinical trials to ensure unbiased~     testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance~     imaging) brain scans and after 96 weeks these will be analysed. We will then compare the~     scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain~     shrinkage that normally occurs in SPMS. This measured change in brain size is the primary~     (major) outcome of MS-SMART.~   "
87638|NCT01910246|"~     It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional~     myocardial contraction, with preserved global cardiac function. Metformin has been shown to~     decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance,~     but the mechanism of cardiovascular protection is unknown.~      The purpose of this study is to evaluate the reversibility of subclinical cardiovascular~     abnormalities in obese adolescents with insulin resistance after a six-month course of~     Metformin. The investigators hypothesized that the beneficial effects of Metformin will be~     progressive and sustained after six months of therapy.~   "
87639|NCT01910233|"~     This is a prospective registry of patients presenting with acute dyspnea to the emergency~     department of the city hospital in Nuremberg. There is evidence that acute dyspnea is~     associated with a mortality rate of 10%, however acute dyspnea is not perceived as a~     life-threatening condition, both in public and in health care providers. Our aim is to~     describe the patient collective concerning their demographics, baseline characteristics,~     type of referral and disposition, medical care processes and prognosis. Secondly, we want to~     evaluate if the subjective risk assessment of emergency department personnel matches with~     objective risk stratification tools and the actual outcome of the studied patients.~   "
87640|NCT01910220|"~     This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy~     volunteers.~   "
87641|NCT01910194|"~     Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion~     and gastric emptying~   "
87642|NCT01910181|"~     This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy~     of vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or~     metastatic melanoma. Participants will receive vemurafenib 960 milligrams (mg) orally twice~     daily until disease progression or unacceptable toxicity occurs.~   "
87643|NCT01910168|"~     In this single center study blood samples for biomarker analysis will be collected from~     patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible~     patients at a single visit.~   "
87644|NCT01910155|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par~     Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin~     0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial~     otitis externa.~   "
87645|NCT01910142|"~     The present study aims to develop a technique based on a single dose of a calcium isotope,~     which enables to determine the effect of a nutritional intervention on bone calcium~     metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K~     will be applied in postmenopausal women. Treatment effects will be determined by the urinary~     excretion of the calcium isotope and related to classical bone markers.~   "
87646|NCT01910129|"~     The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for~     the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.~   "
87647|NCT01910116|"~     GCSB-5 (Shinbaro capsule), is a mixture of 6 oriental herbs that have anti-inflammatory~     and analgesic effects along with an excellent safety profile. This study is aimed at~     investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a~     long term treatment in a placebo controlled, double-blind randomized trial.~   "
87648|NCT01910103|"~     Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the~     that of breast ultrasound in women with dense breast.~   "
87649|NCT01910090|"~     To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20~     mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID®~     (Famotidine) 20mg Tablets, USP.~   "
87650|NCT01910077|"~     The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and~     prograf capsule 1mg.~   "
87651|NCT01910064|"~     This open label study is to determine the safety profile of GK530G in a long-term treatment~     (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a~     long-term treatment.~   "
87652|NCT01910051|"~     The rationale for this trial is to apply a simple and minimally strenuous pre-screening~     approach prior to performing more extensive trial-specific screening and~     baseline-characterization activities in the resulting pre-selected population of subjects.~   "
87653|NCT01910038|"~     The usual percentage of patients receiving 0.1 mg/Kg/d or less of prednisone after 6 months~     of treatment is approximately 40%. We believe that adding tocilizumab to the corticotherapy~     in this protocol could increase the percentage from 40 to 70%.~      From an immunological point of view, we believe we will see not only a fall in the Th17~     response (as with corticoids alone), but also a rise in Treg lymphocytes.~   "
87654|NCT01910025|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has~     been used to treat patients that have cancers that have arginine. In this study, the primary~     efficacy variable will be assessment of tumor response rate.~   "
87656|NCT01909999|"~     The aim of this study was to compare the release of the osteoprotegerin (OPG), transforming~     growth factors (TGF-α), osteocalcin (OCN), osteopontin (OPN), and parathyroid hormone (PTH)~     during osseointegration of dental implants with and without immediate loading. Forty~     patients were selected and randomly divided into: Group IM - implant and prosthesis~     placement within 72 hours; and Group NL - implant insertion and no prosthesis placement~     during 120 days. Peri-implant crevicular fluid (PICF) was collected immediately after~     implant insertion and with 7, 15, 30, 60, 90, and 120 days after surgery and were evaluated~     levels of OPG, TGF-α, OCN, OPN and PTH using Luminex assay. Clinical aspects (Sulcus~     bleeding and peri-implant probing depth) were also assessed. The data were compared using~     the ANOVA/Tukey and Friedman/Mann-Whitney tests (α=5%).~   "
87657|NCT01909986|"~     This is a single dose mass balance study in healthy adult male volunteers to investigate the~     metabolism and excretion of [14C]-ONO-4053.~   "
87658|NCT01909973|"~     The goal of this project is to develop and pilot a mobile smartphone delivered intervention~     that will improve antidepressant medication care by providing medication adherence~     monitoring and support to the patient, feedback on patient adherence and response to~     treatment to the primary care team, and information to both patients and providers on~     guideline-congruent care personalized to the patient's response to antidepressant~     medication.~   "
87659|NCT01909960|"~     Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid~     and blood flow by phase contrast magnetic resonance imaging.~   "
87660|NCT01909947|"~     The investigators hypothesize that machine learning methods using a combination of novel,~     quantitative measures of cardio-respiratory variability can accurately predict the optimal~     time to extubate extreme preterm infants. In this multicenter prospective study,~     cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible~     for extubation. Automated signal analysis algorithms will compute a variety of metrics for~     each infant describing the cardiorespiratory state. Machine learning methods will then be~     used to find the optimal combination of these statistical measures and clinical features~     that provide the best overall predictor of extubation readiness. Finally, investigators will~     develop an Automated system for Prediction of EXtubation (APEX) that will integrate the~     software for data acquisition, signal analysis, and outcome prediction into a single~     application suitable for use by medical personnel in the Neonatal Intensive Care Unit~     (NICU). The performance of APEX will later be clinically validated in 50 additional infants~     prospectively.~   "
87661|NCT01909934|"~     This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the~     efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or~     refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).~   "
87662|NCT01909921|"~     The purpose of this study is to assess the effectiveness of a Relaxation Response~     Intervention for Depression offered to low income populations at Massachusetts General~     Hospital (MGH) - Chelsea, Revere and Charlestown health centers.~   "
87663|NCT01909908|"~     The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a~     clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM)~     and autologous blood products in wound healing.~   "
87664|NCT01909895|"~     The experience of negative emotions is associated with an increased risk of incident~     atherosclerosis-related cardiovascular disease (CVD) events, independent of traditional risk~     factors. The strongest data supporting this relation is with provoked anger. There is also~     some evidence that becoming acutely depressed or anxious are also triggers of incident CVD.~     The underlying putative mechanisms are poorly understood. Vascular endothelial cells (ECs)~     play an essential role in maintaining vascular tone and the integrity of blood vessels.~     Evidence suggests that dysfunction of the endothelium is an early pathogenic process~     underlying atherosclerosis development and CVD event onset. The aims of this study are to~     primarily examine the acute effects of provoked anger and secondarily depressed mood and~     anxiety on EC health. Examination of these critical pathways will help determine whether~     endothelial dysfunction is a biological mechanism linking the experience of core negative~     emotions and incident CVD risk. In this application, a state-of-the-art, laboratory-based,~     randomized controlled experiment is proposed that will test whether provoked anger,~     depressed mood and anxiety will induce endothelial dysfunction in humans. We hypothesize~     that compared to an emotionally neutral condition, an anger recall task will impair~     endothelium-dependent vasodilation, injure ECs, and reduce EC reparative capacity. We will~     also examine whether a depressed mood and anxiety induction task will similarly induce~     endothelial dysfunction, as well as whether levels of provoked self-reported anger,~     depressed mood, and anxiety are associated with the degree of endothelial dysfunction.~     Finally, given that endogenous nitric oxide (NO) inhibition plays a central role in~     exacerbating endothelial dysfunction, we will explore whether NO inhibition partially~     mediates the acute adverse effects of provoked anger, depressed mood, and anxiety on~     endothelial function. In the United States, atherosclerosis-related CVD events remain the~     leading cause of morbidity and mortality. Further, anger, depressed mood, and anxiety are~     negative emotions commonly experienced by adults in the general population on a day-to-day~     basis. Therefore, evaluation of these hypotheses is timely and highly significant, as it~     will help identify a putative biological pathway linking the experience of core negative~     emotions to CVD incidence, for a large number of individuals who are at increased risk for~     CVD events.~   "
87665|NCT01909882|"~     The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale~     Score of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized~     controlled Clinical Trial Study~   "
87666|NCT01909869|"~     One of the purpose of this study is to assess the preliminary safety and feasibility,and to~     provide related information and evidence for the design of the further pivotal randomized~     control trial.the other purpose is to assess the performace of the stent delivery system.~   "
87667|NCT01909856|"~     This study is to assess the efficacy and safety of palonosetron in preventing the acute and~     delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover~     design is used and granisetron is the positive control.~   "
87668|NCT01909843|"~     This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent~     reversibility and prevention, of bronchoconstriction following single and repeated oral~     inhalations of ALX-0171 in adults with hyperresponsive airways.~      This phase I study is an exploratory study and serves to evaluate the occurrence and~     reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label~     trial with a sequential administration regimen of placebo and verum in all planned study~     subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (=~     formulation buffer) followed by escalating doses of ALX-0171 verum.~      Eventually a second administration of ALX-0171 placebo may take place at the end of the~     study (as defined per protocol).~   "
87787|NCT01908270|"~     Women with breast cancer and breast cancer survivors are often bothered by menopausal~     symptoms to a special degree. Treatment options for those symptoms are currently limited as~     hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal~     symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to~     investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with~     breast cancer and breast cancer survivors.~   "
87669|NCT01909830|"~     Study Design:~      Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and~     safety of Gemcitabine/Pemetrexed combination.~      Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12~     cycles lasting 2 weeks).~      Total duration of the study: 24 months.~      Number of Subjects:~      Approximately 38 subjects will be enrolled on study:~      - First stage:12 patients enrolled~      If 1 or 0 responses were observed, the trial had to be terminated:~      - Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses~     were observed in 35 patients, the combination would not be considered worthy of further~     study, while if 6 or more responses were observed, the combination would be considered~     sufficiently active to warrant further testing. Taking into account an invalidity rate of~     5%, 38 patients will be needed for this step.~   "
87670|NCT01909817|"~     The investigators aim to determine whether a new method of enhancing and improving ECG~     acquisition, analysis and display is effective. The investigators will perform~     superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal~     alignment to the peak R wave and voltage alignment to an improved baseline at the T-P~     segment.~   "
87671|NCT01909804|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin~     (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)~     infection.~   "
87672|NCT01909791|"~     Although multiple studies have clearly demonstrated that ranibizumab therapy is more~     effective than laser alone for vision gain and avoiding vision loss in patients with~     central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a~     visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse)~     were eligible. Eyes that have central-involved DME with good visual acuity (20/25 or~     better) have not been addressed systematically by recent studies for treatment of DME.~     Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS)~     suggest that a substantial percentage of eyes with central-involved DME may retain good~     vision. The investigators do not know definitively whether eyes with central-involved DME~     and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g.~     aflibercept) therapy initially, or focal/grid laser treatment or observation initially~     followed by anti-VEGF only if vision worsens.~      The primary objective of the protocol is to compare the % of eyes that have lost at least 5~     letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with~     central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or~     better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid~     photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt~     anti-VEGF.~      Secondary objectives include:~        -  Comparing other visual acuity outcomes between treatment groups, such as the percent of~          eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean~          visual acuity, percent of eyes with at least 5 letter gain in visual acuity from~          baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean~          visual acuity~        -  For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF~          treatment~        -  Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT~          central subfield (CSF) thickness, adjusted for baseline mean thickness~        -  Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding~          vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between~          treatment groups~        -  Comparing safety outcomes between treatment groups~        -  Comparing associated treatment and follow-up exam costs between treatment groups~   "
87673|NCT01909778|"~     This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI~     201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A~     according to Child-Pugh classification (< 7 points).~   "
87674|NCT01909765|"~     To compare the effect of two different surgical techniques, the dorsal slit and double~     incision technique, on postoperative pain.~   "
87675|NCT01909752|"~     This study will test an investigational vaccine, called DRibbles, for the treatment of~     non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine~     will cause an immune responses against proteins contained in the DRibble vaccine and the~     protein antigens targeted by this strong immune response will include common antigens shared~     by both the vaccine and the patient's tumor.~   "
87676|NCT01909739|"~     The aim of this study is to examine the association between preoperative statin treatment~     and the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular~     heart surgery.~   "
87677|NCT01909726|"~     The purpose of this study is to test the hypothesis that providing low-intensity~     opportunities for interactive play can improve the waiting and overall clinic experiences of~     children. This study evaluates an innovative, interactive system called ScreenPlay designed~     to realize the intentions of the Healing Environment in the waiting space of a paediatric~     hospital.~   "
87678|NCT01909713|"~     The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam~     Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.~   "
87679|NCT01909700|"~     Objectives: To evaluate whether the use of single incision un-anchored small mesh implants~     is feasible, safe and effective for women with moderate pelvic organ prolapse.~      Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a~     single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome~     measures for this study were the operative safety and post-operative pain, adverse effects~     and anatomical as well as functional cure.~      Setting: The operations were performed under general anesthesia according with the reported~     surgical techniques at university and private hospitals.~   "
87680|NCT01909687|"~     System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test~     strips per systems according to ISO 15197:2013~   "
87681|NCT01909674|"~     Our group previously conducted a study looking at the performance of three styles of~     positive airway pressure masks during laboratory treatment studies for obstructive sleep~     apnea, and we found that patients using a full-mask mask required higher positive airway~     pressures than patients using nasal or nasal pillows style masks to achieve successful~     reduction of respiratory events. In the current study we want to randomly assign patients to~     either nasal or full-face masks and then switch to a different mask (if nasal was originally~     chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to~     see if the number of respiratory events change with the different mask style. We expect the~     number of respiratory events will increase with the use of full-face masks.~   "
87682|NCT01909661|"~     The objective of this double blinded randomized study is to assess the tolerance of two~     extensively protein hydrolyzed infant formulas, one based on rice protein and the other one~     on casein, at introduction, and after 3 months of consumption, and their efficacy on growth~     and on the reduction of allergy symptoms through a 3 months consumption period.~   "
87683|NCT01909648|"~     The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on~     routine HbA1c measurements.~   "
87684|NCT01909635|"~     Kelsey Wallour and Dr. Hollie Raynor are doing a study to investigate the effect of focusing~     on certain thoughts and feelings during a meal on liking of items in the meal. A total of 36~     women are anticipated to participate in this study.~   "
87685|NCT01909622|"~     Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not~     been suspected before. The most cost-effective method for reducing population-wide VDD is~     through fortification of commonly consumed foods. Nevertheless, the efficacy of~     fortification varies by dose, duration, and population characteristics; and it is currently~     unknown whether it could be an efficacious public health intervention to curb the VDD~     epidemic among children living in tropical areas. We propose to conduct a randomized,~     controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on~     serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá,~     Colombia. Eighty families with a child participating in an ongoing cohort study will be~     randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3~     per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to~     give the index child two cups of milk per day and to distribute the remaining milk to the~     rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers~     at baseline and at the end of the intervention period.~   "
87686|NCT01909609|"~     The American Academy of Pediatrics changed their stance on circumcision to health benefits~     of newborn male circumcision outweigh the risks and that the procedure's benefits justify~     access to this procedure for families who choose it (AAP, 2012).~      We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to~     make this medical decision by weighing the risks against the benefits of circumcision, or do~     they simply use sociocultural/religious reasons to make this decision? We hypothesize that~     parents are unaware of the specific benefits and risks of circumcision, and make this~     decision based primarily on sociocultural, religious, and/or familial norms.~      Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be~     recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to~     accrue at least 680 participants for this study in order to achieve statistical significance~     and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will~     be encouraged to participate.~      This survey will assess their desire to get their child circumcised when they are born.~     Participants will be asked to list perceived risks and benefits of circumcision. This will~     hopefully allow us to see two things: if parents are aware and knowledgeable of the risks~     and benefits or circumcision, and what they perceive to be risky or beneficial from a~     medical standpoint.~      Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single~     mother]; 1 control, 1 experiment) with different information about circumcision. We will see~     if there are any outcome differences based on which group the couple randomized into.~     Follow-up phone call will serve to assess outcome if baby was circumcised and any factors~     that led up to the decision. This will allow us to see if the AAP stance has any effect on~     decision making when we compare the control and experiment groups.~   "
87687|NCT01909596|"~     The purpose of this is to test lateral foot orthoses with different amount of wedging to~     find a model that predicts the optimal lateral inclination of foot orthosis based on~     biomechanical or feelings measures. This study was a cross-sectional study with patients~     serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee~     radiography and clinical angles measures was carried out before making orthoses, then motion~     analysis with an optoelectronic system was performed with each pair of foot orthoses. During~     motion analysis, five gait trials were carried out in each condition.~   "
87688|NCT01909583|"~     We have developed a pre-operative educational / counselling booklet with the focus on~     informing parents / patients about the different stages before, during, and after cardiac~     surgery that they will encounter; both chronologically and emotionally. With this approach~     and study our objectives are:~      1. To provide anticipatory guidance for parents to decrease parental stress and improve~     parental experience and preparedness, thus involving the parent as a partner in caring for~     their child.~      We hypothesize that this additional tool will improve parental satisfaction in regards to~     being prepared for their child's heart surgery.~   "
87689|NCT01909570|"~     The purpose of this study is to determine whether a policy of elective single embryo~     transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer~     in terms of clinical pregnancy rate~   "
87690|NCT01909557|"~     To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional~     substances administration on work productivity, daily activity, and fatigue in subjects with~     chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.~   "
87691|NCT01909544|"~     The purpose of this study is to investigate whether a localized exercise, in which~     cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients~     with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.~   "
87692|NCT01909531|"~     The primary goal of this study is to evaluate and compare outcomes, trends, and~     effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments,~     target selection, targeting accuracy and outcomes in patients with Parkinson's disease and~     Essential tremor.~   "
87693|NCT01909518|"~     The aim of the present study：~        1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.~        2. To assess the detection rate of early esophageal squamous neoplasia by virtual~          chromoendoscopy~   "
87694|NCT01909505|"~     Low testosterone is a common male problem. The diagnosis of low testosterone often requires~     blood sampling and expensive testing. We want to know if measuring saliva testosterone can~     be used in place of blood sampling. Study participants will be asked to provide samples of~     blood and saliva for the measurement of testosterone. These results may lead to the~     development of a saliva test for testosterone.~   "
87695|NCT01909492|"~     This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.~   "
87696|NCT01909479|"~     This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter~     study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once~     weekly injection of modified hGH (MOD-4023).~   "
87697|NCT01909466|"~     To determine the safety and tolerability of multiple-dose administrations of aripiprazole~     intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia~   "
87698|NCT01909453|"~     This is 2-part, randomized, open label, multi-center, parallel group, phase III study~     comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818~     monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF~     V600 mutation. A total of approximately 900 patients will be randomized.~      Part 1:~      Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:~        1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)~        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or~        3. vemurafenib 960 mg BID (denoted as vemurafenib arm)~      Part 2:~      Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:~        1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or~        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)~   "
87702|NCT01909401|"~     Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus)~     medications for those preparing for a liver transplant. The purpose of this study is to~     determine whether those individuals who require liver transplantation for Hepatitis C,~     genotype I, who are undergoing liver transplantation may successfully get rid of their virus~     before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir,~     up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will~     not re-infect the new liver that they receive and they will not require therapy for~     Hepatitis C after liver transplantation. This study involves the use of peginterferon~     alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype~     I Hepatitis C.~      Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients~     with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic~     liver transplantation will lead to rapid HCV RNA clearance of genotype I infected~     individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new~     transplanted graft and prevent graft infection posttransplantation.~   "
87703|NCT01909388|"~     The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an~     appropriate assessment of the local extent of the disease. Recent studies have shown an~     increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions~     when using multiparametric MRI as a diagnostic tool in the staging of the disease.~      Among the various irradiation techniques currently available for prostate cancer,~     Brachytherapy is the superior in terms of dose conformation; this conformation allows~     greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy,~     keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range~      Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.~      The purpose of this study is to demonstrate the feasibility of the delivery of a higher than~     prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.~      Dose to prostate, and adjacent structure will remain the same as the current treatment~     practice. Timing and the delivery of brachytherapy will not change from our current practice~   "
87704|NCT01909375|"~     The American Joint Replacement Registry is a not-for-profit 501(c)(3) organization for data~     collection and quality improvement initiatives for total hip and knee replacements. The AJRR~     is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS),~     the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee~     Society, hospitals, health insurers, medical device manufacturers, and contributions from~     individual orthopaedic surgeons.~   "
87705|NCT01909362|"~     Patients are being asked to participate in this study who have colorectal cancer that has~     come back after initial treatment. The investigators want to improve treatment in patients~     with this disease. In other types of cancers, it has been possible to improve treatment by~     studying the gene mutations (called biomarkers) in a patient's cancer and matching these~     to existing cancer therapies or study drugs which target that specific mutation. Colorectal~     cancers have not been routinely tested in this way.~      In this study, investigators will determine whether mutational testing can be successfully~     done on colorectal cancers and how often mutations are detected for which there are existing~     drugs (or drugs in development). The results will be used to determine if treating~     physicians use this information in planning subsequent treatment.~   "
87706|NCT01909349|"~     Persons undergoing cardiac rehabilitation often have difficulties transferring the learned~     health behaviors into their daily routine which decreases their health status.~     Computer-based tailored interventions have been shown to be effective in increasing physical~     activity as well as fruit and vegetable consumption. The aim of this study is, to support~     people in transferring these two learned behavior changes and their antecedents into their~     daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary~     goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with~     regard to the level of physical activity and nutrition.~   "
87707|NCT01909336|"~     The purpose of this study is to determine if isotonic solutions reduce the risk of hospital~     acquired hyponatremia compared with hypotonic solutions.~   "
87708|NCT01909323|"~     Digestive symptoms following consumption of low digestibe carbohydrates are generally~     assessed product by product but several ingredients can be used simultaneously. The study~     aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.~   "
87709|NCT01909310|"~     After routine induction of general anaesthesia peak airway pressure (= P max) and other~     respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and~     without head support in three different head positions: neutral position, reclination of the~     head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on~     different head positions;~   "
87710|NCT01909297|"~     The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways~     in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak~     pressure. The investigators also studied their relative ease of insertion, time to insertion~     and complications of use as secondary outcome measures.~   "
87711|NCT01909284|"~     This study is being conducted to investigate the effectiveness and safety of acupuncture for~     alleviating pain of spondylosis.~   "
87721|NCT01909141|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age.~     Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS.~     The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American~     College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer~     metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone.~     Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be~     associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may~     improve this condition. In this study we will compare the effect of combined~     letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in~     ovulation induction in CC-resistant PCOS women.~   "
87722|NCT01909128|"~     The respiratory and gastrointestinal infections are a very common problem with high~     morbidity in children. These conditions were due, in general, immaturity and all~     inexperience of the immune system, as well as to the particular anatomical structure and~     function of the respiratory and gastrointestinal tract still developing. This inevitably~     means that school-age children develop disease (as a result of infection) more easily than~     at later ages. The frequency and duration of these conditions implies a high discomfort and~     incur significant costs in relation to drug administration, the need for hospitalization,~     days of absence from school and work days lost by parents.~      Recently probiotics, defined as microorganisms that prove able, once ingested in adequate~     amounts, exert beneficial functions for the body have been proposed for the treatment of~     treatment of respiratory and gastrointestinal infections of childhood but only in recent~     years have been conducted controlled clinical trials that have conclusively proven~     effectiveness. All probiotics induce an immune response, the characteristics of which are~     related to the strain or the mixture of bacteria used. Recent studies have demonstrated~     positive effects of probiotics on the respiratory system, and in particular on the~     prevention and reduction of the severity of respiratory infections, probably mediated by an~     increase of cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that~     probiotics can be a sure way to reduce the risk of early acute otitis media and the use of~     antibiotics for recurrent respiratory infections during the first year of life. Similar~     results were seen in a study conducted on a population of 326 children aged between 3 and 5~     years, who found a decrease in the incidence of antibiotic use by over 65% and a reduction~     of days of absence of more than 25% among children treated with a probiotic. Many of the~     studied effects of probiotics, understandably, refer to the digestive system. These effects~     relate to both conditions paraphysiological (constipation) and more specifically in~     situations of illness.~      Most of the studies carried out in recent years has demonstrated the efficacy of specific~     probiotics in reducing the symptoms in the pediatric population affected by infectious~     gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and~     reduce the frequency of diarrheal episodes in the first few hours.~      The microbiota on the other hand participates in the function of the mucosal barrier against~     the adhesion of pathogenic bacteria, crucial time for the start of the infectious process.~      When this barrier function is altered by chemical agents, by antigens or by stressors of~     different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria~     pathogens. Numerous experimental data suggest that probiotics can contribute to the~     reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the~     functionality of the intestinal epithelial cells or macrophages.~      More recently it has been shown that daily intake for 3 months of preparation with~     probiotics reduce the incidence and severity of the most common respiratory infections and~     limits the number of days of absence school children during the winter season.~      It's scientifically recognized as some probiotic effects can also be obtained with the use~     of inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been~     recently proposed a modified definition of probiotic products as prepared bacterial cells~     or bacterial components that have a beneficial effect on the health and welfare of the~     host.~      Among these products probiotic-like fall ingredients object of this study: food~     ingredients (rice flour and skim milk) fermented, or in which has been made to grow a~     probiotic (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation~     process through a heat treatment. The benefits are attributable to bacterial components that~     remain in the final product (for example, DNA, cell wall, etc.) and factors produced during~     the fermentation (short chain fatty acids, bacterial proteins, etc.).~      The main effects of these bacterial components relate to the stimulation of the~     gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the~     immune cells via Toll-like receptors.~      In addition, some components, such as proteins and peptides, may have a Bifidogenic activity~     and are available in the literature some studies that have demonstrated the ability of~     infant formula, milk-based fermented to reduce the severity of episodes of infectious~     diarrhea in children.~      With this data, the Commission of the European Society of Nutrition Gastroenterology,~     Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only~     safe but to determine a potential prebiotic effect and the reduction of the severity of~     episodes of infectious diarrhea.~   "
87788|NCT01908257|"~     This is a drug-drug interaction study in healthy volunteers to evaluate the potential~     pharmacokinetic (PK) effects of ranitidine on lesinurad.~   "
87789|NCT01908244|"~     The purpose of this study is to determine the effects of pentatonic live music on~     physiological parameters in preterm infants.~   "
87712|NCT01909271|"~     Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion~     annually. Interventions designed to educate patients to seek treatment sooner when a stroke~     occurs may increase low rates of treatment with thrombolysis (current rates 3% national~     average). Thrombolysis can increase the odds of minimal to zero disability from stroke if~     emergency medical system response times and in-hospital response times are optimized~     (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and~     Hispanic Americans have higher stroke incidence compared to Whites and are less likely to~     receive thrombolysis for acute stroke. The latency to hospital arrival is largely dependent~     on patients'recognition of stroke symptoms, and immediate presentation to the emergency~     department. Our group has found very low stroke literacy rates among Blacks and Hispanics~     compared to Whites, which may, in part, be responsible for disparities in acute stroke~     treatment. Building on our previous work, in which the investigators have identified~     barriers to increasing stroke literacy and behavioral intent to call 911, the investigators~     will develop and evaluate the effectiveness of a novel, culturally tailored intervention~     using storytelling (narrative persuasion) in the form of two professionally produced 12-min~     films (in English and Spanish), in minority populations in New York City. The investigators~     hypothesize that participants in the intervention arm (who view the stroke education film)~     will demonstrate greater behavioral intent to call 911 for suspected stroke compared to~     those in the usual care arm, who will receive written stroke education materials. Behavioral~     intent to call 911 will be assessed immediately after viewing the film, 6 months later, and~     one year later.~   "
87713|NCT01909258|"~     The main objective of this study is to describe for the first time the expansion reserve of~     the pelvic area (measurements using the EOS system) for each of the four morphotypes~     (Roussouly classification) commonly found in a population of healthy volunteers.~   "
87714|NCT01909245|"~     City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on~     islet cell transplantation, an experimental procedure being evaluated as a treatment for~     patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing~     cells from organ donors and transplanting them into the liver of a patient with diabetes.~     Once transplanted, the islets produce insulin, which can improve blood sugar control and~     eliminate the need to inject insulin or use an insulin pump.~      Anti-thymocyte globulin (ATG) is an anti-rejection medication that works by decreasing a~     patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted~     things like infections but can also attack transplanted cells and organs. Reducing the~     number of T-cells at the time of transplant is expected to protect islets and improve~     long-term transplant results. Transplant programs around the world have seen improved islet~     transplant results using T-cell depleting medications. Approximately 5-6 out of every 10~     patients remain off insulin five years after transplant. These results are similar to those~     achieved with whole pancreas transplant without requiring major surgery, and therefore, may~     be an option for patients who are not eligible for a whole pancreas transplant.~      The purpose of this study is to determine if islet cell transplantation using ATG, along~     with additional medications to prevent the body from rejecting the transplanted cells, is a~     safe and effective treatment for type 1 diabetes. Study participants may receive up to three~     islet transplants and will be followed for five years to monitor blood sugar control, islet~     transplant function, and changes in quality of life.~   "
87715|NCT01909232|"~     The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe~     and effective in the treatment of depression in people who do not get better with~     antidepressant medications or cannot take antidepressant medications.~   "
87716|NCT01909219|"~     This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients~     aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is~     associated to higher efficacy and acceptability in comparison to the standard dose regimen~     in bowel cleansing before colonoscopy~   "
87717|NCT01909193|"~     Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual~     cognitive behavior therapy, attention bias modification treatment (allocation ratio -~     1.5:1).~      Outcome measures will be social anxiety symptoms and severity as measured by gold standard~     questionnaires as well as diagnosis of social anxiety disorder derived from structured~     clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.~      The investigators expect to find significant reduction in social anxiety symptoms in all of~     the groups, with the cognitive behavior therapy group showing greater reduction in symptoms~     than the other groups. Mechanisms of change in all of the groups will be examined via~     measures of cognitive biases, affect, and other common and specific factors.~   "
87718|NCT01909180|"~     An external evaluation to obtain clinical data to create sample clinical images.~      The data will also be used for product and technology development, marketing materials, and~     inclusion in publications.~   "
87719|NCT01909167|"~     Most depression during pregnancy is undetected and untreated although it is known to be~     harmful both to the woman herself and her future child. When these mental disorders are~     detected, psychotherapies remain difficult to access, especially in primary care, despite~     being effective.Also, prenatal depression is known to be a strong risk factor for postnatal~     depression and may prejudice the mother-infant relationship. This leads us to the following~     question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more~     effective treatment for symptoms of depression in pregnant women, than treatment as usual~     (TAU)?~      The proposed randomized controlled trial aims at evaluating the efficacy of internet based~     cognitive behavioural therapy(CBT) delivered individually via skype, using video and audio~     resources, by a fully trained psychotherapist, compared to treatment as usual, in women~     suffering from symptoms of depression in pregnancy.~      Hypothesis The internet based interventions will be more effective at reducing symptoms of~     depression in pregnant women than treatment as usual, in terms of rates of diagnoses and~     levels of self rated symptoms of depression.~   "
87720|NCT01909154|"~     The purpose of this study is to confirm the security, and detect the effect of the local~     administration in damaged nervous tissue, of autologous bone marrow stromal cells.~   "
87745|NCT01908829|"~     The purpose of this study is to see if adding a new type of medication recently approved to~     treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) will be~     more effective in controlling incontinence than when using the antimuscarinic treatment~     alone.~   "
87723|NCT01909115|"~     Vitamin D deficiency is common in the general population and more common in children with~     chronic kidney disease. Vitamin D is very important for bone health, especially in children~     with chronic kidney disease. To date, several studies using different doses of vitamin D~     have been tried to correct vitamin D deficiency, but none has been completely successful.~     The investigators are comparing two different doses of vitamin D to determine which one is~     more effective at correcting and maintaining normal blood levels of vitamin D. The~     investigators hypothesize that a higher percentage of children receiving a higher dose of~     vitamin D will be vitamin D replete at the end of 6 months.~      This study will enroll 80 children 9 to 18 years old who have chronic kidney disease and can~     take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis~     Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.~      After the investigators obtain informed consent and assent, children will be randomly~     assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D~     pills (50% in each group). Patients will be in this study for 6 months. They will take~     vitamin D pills for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6~     months. The study visits will be at the same time as routine clinic visits when the children~     are having blood drawn for routine care. At the end of the study, the investigators will~     compare the percentage of patients who have normal vitamin D levels at 6 months in the two~     groups. The investigators will also describe the percentage of patients who have elevated or~     low levels of trace elements.~      The two doses of vitamin D in this study are within the dosing range recommended by the~     Institute of Medicine, and thus the investigators do not anticipate any adverse effects.~     Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months~     would be an indication to withdraw a patient from the study.~   "
87724|NCT01909102|"~     The study will determine whether a brief intervention program based on Acceptance and~     Commitment Therapy can be effective for the reduction of modifiable risk factors and~     improvement of psychological well-being in patients referred to cardiac rehabilitation~   "
87725|NCT01909089|"~     Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide~     analgesia for labour pain. Despite the increasingly widespread use of this technique, an~     optimal intrathecal drug regimen has not been established yet.~      Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and~     Ropivacaine in CSE during labour have been published. But despite the reintroduction of~     Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine.~     Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic~     profile. It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid~     metabolism by plasma cholinesterases and short half-life both in mother and fetus.~      Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical~     anesthesia. Several investigations demonstrate that for surgical anesthesia doses~     Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical~     duration of 40 - 90 minutes.~      Despite these standards for surgical anesthesia, little is known about spinal~     Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the~     minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour~     using a CSE procedure. We will use the up-down sequential allocation to identify the median~     effective dose (ED50) or concentration (EC50).~      The Effective dose in 95% of the population (ED95) can be estimated also from an up-down~     sequential allocation and will become an important valuable approximation of the clinical~     dose.~   "
87726|NCT01909076|"~     Prescription opioid misuse is a significant public health problem as well as a patient~     safety concern. Primary care providers are the leading prescribers of opioids for chronic~     pain, yet few providers follow standard practice guidelines regarding assessment and~     monitoring. The investigators propose a novel system change in delivery of primary care~     services to decrease misuse of and addiction to prescription opioids for patients with~     chronic pain.~      The proposed intervention for the overall project includes a nurse-managed registry for~     planning individual patient care and conducting population-based care for a population of~     patients receiving opioids for chronic pain. Academic detailing to clinicians is another~     effective way to improve care. Finally, the researchers will create a knowledge management~     tool to facilitate guideline adherence. This tool will be accessible via an internet link,~     and will include validated instruments to assess patient status and also to facilitate~     physician adherence to suggested monitoring.~   "
87727|NCT01909063|"~     The goal of this investigator-initiated study is to determine whether the fortification of~     orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A,~     and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at~     Boston University Medical Center. Circulating concentrations of 25-hydroxyvitamin D~     [25(OH)D], vitamin A, and vitamin E before, will be measured at mid-intervention (week 6),~     and after a period of twelve weeks. This study plans to recruit 180 male and female subjects~     between the ages of 6 and 10. An informed consent will be explained and discussed with the~     subjects and their parents/guardians willing to participate in the study. The study will be~     twelve weeks. Blood will be drawn during the initial visit, mid-intervention (week 6), and~     week 12. Dietary intake will be assessed at baseline and at the conclusion of the 12-week~     intervention using a 3-day food record. The subjects will be randomized in a double-blinded~     manner via an electronically shuffled listed. Subjects will be randomized to receive one of~     three beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2)~     calcium plus vitamins D, A, and E fortified orange juice (intervention B) or (3)~     calcium-only fortified orange juice (controls). Subjects in all groups will drink two 8-oz.~     glasses of juice at least six hours apart (morning and afternoon) per day for a period of 12~     weeks. Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of~     calcium per day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU~     vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of~     juice, while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood~     sample will be obtained before the subjects begin drinking the orange juice and at week 12~     to determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be~     used for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase,~     phosphorus, calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample~     will also be obtained at week 6 for 25(OH)D and PTH.~   "
87728|NCT01909050|"~     The main purpose of this study is to see how cells taken from the lining of the intestine~     behave in the laboratory with exposure to gluten and other substances that act on the immune~     system. The cells lining the intestine of a person with celiac disease should be different~     than a person without celiac disease. The study doctors would like to see how the cells~     react after coming in contact with gluten and if substances that act on the immune system~     can prevent gluten related inflammation. Examples of these substances include steroids. The~     cells should produce chemicals of their own in response to the gluten. These other chemicals~     will be measured and the results compared between those with:~        -  celiac disease that does not respond to a gluten-free diet (refractory celiac disease)~        -  celiac disease which is controlled by a gluten-free diet~        -  uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a~          gluten-free diet~        -  gluten-sensitivity~        -  disorders other than celiac disease.~   "
87729|NCT01909037|"~     The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol)~     during a 90-days period in knee ostearthritis patients on the serum levels of specific~     biomarkers of osteoarthritis and on the evaluation of pain.~   "
87730|NCT01909024|"~     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic~     embolisation) in females with recurrent leg varicose veins, who have a proven contribution~     to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence~     after endovenous laser treatment for recurrent varicose veins in the legs.~   "
87731|NCT01909011|"~     The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy~     Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of~     daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on~     EEG reading.~      The investigators hypothesize:~        1. The CES will reduce symptom severity more than sham (placebo) CES.~        2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated~          when treating bipolar II patients.~        3. That CES will shift the alpha and beta power fractions of EEG downward, and that this~          shift correlates with a decrease in level of anxiety and depression~   "
87732|NCT01908998|"~     The Y-balance test is a lower extremity, dynamic test performed in single limb stance that~     measures a person's ability to reach in 3 directions. The test is typically conducted in~     barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test~     scores. The investigators hypothesize that by improving alignment and augmenting muscle~     mechanics, sandals with medial arch support may improve Y-Balance scores.~   "
87733|NCT01908985|"~     Monocentric prospective study conducted in two phases evaluating the secretion and~     elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with~     cyclo-coagulation with ultrasound.~      Population selected:~      - Patients with refractory open angle glaucoma despite previous treatments currently~     validated for glaucoma.~      The purpose of our study is:~      - To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high~     intensity focused ultrasound in studying the secretion and elimination of aqueous humor by~     fluorophotometry.~      Planning:~        -  First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of~          aqueous humor production at one month in the first two patients in the feasibility~          study, further in second phase.~        -  Second phase: 6 patients~   "
87734|NCT01908972|"~     The purpose of this study is to determine the safety and efficiency of Propranolol as an~     initial treatment for pediatric hemangioma.~   "
87735|NCT01908959|"~     The purpose of Madres Para la Salud [Mothers for Their Health] is to see how support and~     encouragement can help women to make positive changes in their health. This program tested~     if supportive information, encouragement, and walking as a group would increase physical~     activity and health benefits, such as weight loss and postpartum depression.~      Participants in this study were randomly assigned to one of two groups, a walking or a~     non-walking group. The walking group met weekly. Participants were given a pedometer to~     record the number of steps taken daily.~      Participants met one time each week with our study staff. Participants walked four other~     days per week on their own, or with other group members. Participants measurements included~     body fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The~     non-walking group received a weekly mailed newsletter about topics such as parenting, infant~     growth and development, and reproductive health. Non-walking group participants'~     measurements included body fat, waist, and hip at the beginning of the study and at 6 and 12~     months.~   "
87736|NCT01908946|"~     The investigators plan to test the effectiveness of reminders to parents/guardians on cell~     phones through short messaging system (SMS) in improving the on-time routine immunization~     for children in Pakistan. SMS message as a reminder tool can be very effective in health~     care settings at public health scale. This study will be conducted in an urban- squatter~     settlement area, Ibrahim Haidry union council in Karachi. Parents/guardians of children~     randomized in intervention arm will be sent SMS reminders vaccination visit reminders at 6,~     10 and 14 weeks of life.~   "
87737|NCT01908933|"~     The purpose of this study is to prospectively evaluate the safety and efficacy of the~     AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous~     Emphysema.~   "
87738|NCT01908920|"~     The aim of the present study is to determine the extend to which osteopathic manipulative~     treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF)~     parameters.~   "
87739|NCT01908907|"~     The purpose of this study is to understand if the DHA gap can be corrected by giving a~     daily dose of DHA oil to preterm babies.~      DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to~     take it in through our diet. DHA is important for normal brain and eye health and it may~     also decrease inflammation. This is important for premature babies because they are at a~     greater risk for getting diseases related to inflammation, especially in their lungs, eyes~     and intestines. Since DHA is so important for normal growth, you will find DHA naturally in~     breast milk and it is now added to infant formula. But the amount in breast milk and infant~     formula is about half of what your infant should expect to get in the womb (about 13-29mg~     per day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an~     even greater disadvantage because they cannot always eat very much right away and that is~     the only way they can get essential fatty acids in their body. This means premature babies~     are getting less DHA than they would in the womb and then the DHA gap continues for a~     longer period of time. This gap also comes at a time when their brain is growing most~     rapidly and their bodies need it the most. This trial is designed to see if giving DHA, even~     before the baby can take food orally, will raise his/her DHA blood levels to those of normal~     term babies.~   "
87740|NCT01908894|"~     The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and~     compare them to Humalog.~   "
87741|NCT01908881|"~     The purpose of this study is to determine whether a group intervention for primary health~     care dyads (two interacting people, in this case: mother-infant or caregiver-infant), which~     have been screened during pregnancy to be at psychosocial risk, has an impact on parental~     sensitivity.~   "
87742|NCT01908868|"~     The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in~     diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial~     lung biopsy.~   "
87743|NCT01908855|"~     The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with~     strategies from emotion regulation training leads to better improvement in somatic symptoms~     and comorbid problems than cognitive-behavioral therapy alone.~   "
87744|NCT01908842|"~     The purpose of this study was to assess retention in treatment after induction with~     buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and~     after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives~     included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and~     safety.~   "
87755|NCT01908699|"~     This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess~     the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in~     patients with pulmonary arterial hypertension.~      Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of~     experience is achieved to ensure drug tolerability before enrolling in the study.~      Treatment groups consist of one active and one placebo group. Subjects will be randomly~     allocated in a 1:1 ratio to one of the two treatment groups.~   "
87756|NCT01908686|"~     The purpose of this study is to evaluate the application of an evidence-based, manualized~     treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT)~     to children ages four through six years of age with ASD. Specifically, children will be~     randomly assigned to receive either (1) 10 hours per week of intervention services,~     including two hours per week of parent education, and eight hours per week of direct~     clinician-delivered services, or (2) a treatment as usual control. Intervention will focus~     on enhancing the following developmental skills: expressive and receptive language, play,~     and social interaction. Outcome measures will address changes in the aforementioned domains~     during structured observation and standardized assessment.~   "
87757|NCT01908673|"~     Background: Depression in the elderly, also known as late life depression (LLD) is common~     and its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a~     physiological autonomic variable is reduced in LLD and this might have implications for~     cardiovascular events including death. Methods to improve HRV in LLD have not been~     adequately assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful~     technique that allows the mind to become calm and peaceful. HRV biofeedback is a method of~     teaching individuals to voluntarily improve HRV and other physiological functions to a~     prescribed range.This pilot study attempts to investigate feasibility of these interventions~     and provide preliminary data regarding the effectiveness of these techniques.~      Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV~     in patients with LLD can be assessed.~      Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either~     ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will~     receive training and continue practice in either of these techniques over a period of twelve~     weeks. HRV and secondary measures will be assessed pre and post at the end of study period.~      Expected Results and Significance: The investigators expect to find both techniques to be~     feasible treatments for those with LLD. Results from this pilot study will help to assess~     the potential for successful implementation of a future larger study which will evaluate the~     efficacy of these treatments for improving HRV.~   "
87758|NCT01908660|"~     The purpose of this study is to compare the liver toxicity in HIV-infected patients with~     chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well~     as the influence of the degree of pre-existing liver fibrosis on the incidence of liver~     toxicity.~   "
87759|NCT01908647|"~     In this randomized, controlled clinical trial, we will evaluate the effects of (1) a~     brain-training program that uses real-time neurofeedback in functional magnetic resonance~     imaging (fMRI) to allow people to learn how to gain voluntary control over activity in~     targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a~     software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training~     tasks on cognitive learning and symptoms. In addition, the investigators will measure brain~     function (active and resting functional magnetic resonance imaging) and structure (high~     resolution magnetic resonance imaging) before and after treatment.~   "
87760|NCT01908634|"~     Primary objective is to evaluate the influence of matrix on the bioavailability of key~     phytochemical constituents in fruits and their subsequent effect on chronic disease risk~     factors.~   "
87761|NCT01908621|"~     The purpose of the study is to compare safety and efficacy of stem cell mobilization using~     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple~     myeloma patients.~   "
87762|NCT01908595|"~     This study is to evaluate the efficacy and safety for long term use of M518101 in subjects~     with plaque psoriasis.~   "
87763|NCT01908582|"~     The main purpose of this study is to determine how much evacetrapib gets into the blood~     stream and how long it takes the body to get rid of it when given with rifampin. The safety~     and tolerability of the two drugs, given together, will also be evaluated. The study will~     also look at blood cholesterol levels and levels of a hormone called cortisol before and~     after taking rifampin. Information about any side effects that may occur will also be~     collected.~      For each participant, this study will include 2 periods in fixed order. The study will last~     approximately 29 days.~   "
87764|NCT01908569|"~     The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads,~     magnetic particles with a diameter of 35 nanometers joined to the compound annexin V.~     Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system~     allow us to eliminate those spermatozoids which have begun the apoptosis and have~     phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic~     spermatozoids will join the microbeads and consequently be retained in a column applying a~     magnetic field.~      Recent studies show the benefits of spermatozoid selection using MACS and the improvement in~     mobility, viability, DNA fragmentation and fertilization potential. It has also been~     observed an improvement in the embryo cells division rate, clinical pregnancy rates and~     spermatozoid survival after thawing. However, it is necessary to perform new clinical~     studies in order to evaluate the real potential of this technology and its safety.~      The purpose of this study is to evaluate the effect of the MACS technique on the clinical~     results of good-prognosis patients who are going through IVF/ICSI treatments in order to~     achieve a pregnancy.~      The hypothesis of this study is that the application of the MACS technique in assisted~     reproduction treatments is associated with a better embryo quality and pregnancy rates.~   "
87790|NCT01908231|"~     To prospectively investigate the association between plasma lactate concentration and~     short-term adverse outcomes in patients with acute PE.~   "
87897|NCT01906840|"~     Despite advances in prevention of cardiovascular diseases, the incidence of accelerated~     atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is~     considered as a major player in uremia associated morbidity and mortality in HD patients.~     The aim of this study was to evaluate the effects of turmeric on oxidative stress markers in~     HD patients.~   "
87765|NCT01908556|"~     Aromatase inhibitors have shown a superior efficacy compared to tamoxifen in the treatment~     of hormonal receptor positive breast cancer in postmenopausal patients.~      Side effects like osteoporosis, bone fractures and muscle/bone pain are however more~     frequent using of aromatase inhibitors compared with tamoxifen. These side effects~     compromise the patients' well being in a significant way and may favour the use of Tamoxifen~     in clinical practice.~      Furthermore there is evidence that polymorphisms in the CYP2D6 Gene might be associated with~     an improved efficacy of Tamoxifen that is equieffective to aromatase inhibitors.~      Concerning the pharmacogenetics of aromatase inhibition there are known polymorphisms of the~     CYP19A1 gene that are associated with altered peripheral sex hormone levels and altered~     prognosis in breast cancer patients. One study could even associate a polymorphism in the~     CYP19A1 gene with a prolonged time to progression in patients with metastatic breast cancer~     who have been treated with letrozol.~      Therefore the aim of this study is to identify biomarkers that could predict the efficacy of~     an adjuvant Letrozol treatment in postmenopausal breast cancer patients.~   "
87766|NCT01908543|"~     Managing iron deficiency is important for more than 1 billion individuals worldwide, to~     avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing~     haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for~     people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron~     deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and~     they often need additional iron to replace that lost through bleeding.~      Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra~     iron they need to adjust for their current and likely future blood losses; and to work out~     how to achieve this most safely for each individual to improve their later health.~      We will test the hypothesis that informed assessment of iron intake and post absorption~     cellular profiles changes the recommendations for iron intake for HHT patients.~   "
87767|NCT01908530|"~     The purpose of the study is to assess the safety and efficacy of the Imperial College~     Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1~     diabetes.~   "
87768|NCT01908517|"~     There has been very limited research that has looked at electronic reminders (text messages)~     and its effectiveness in adherence to vaccination among low-income minority populations.~     Results have shown that text messages, among low-income parents and adolescents who were~     identified as having a cellphone, is an effective strategy to increase the likelihood of~     adolescent vaccination adherence. Hard copy and electronic messaging reminders have also~     been proven to be effective when coupled with other prevention strategies for immunizations~     for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical~     cancer in adults. Additionally, Merck and Co. recommend electronic reminders in their~     patient compliance program as a key strategy for adherence. To our knowledge, this~     community-based pilot intervention study will be the first to assess electronic reminders~     and HPV vaccine initiation and adherence among rural uninsured and Medicaid populations. The~     investigators hypothesize that adolescent whose parents who receive the intervention will be~     more likely to initiate HPV vaccination and be compliant at 3 months and at 7 months as~     compared to the control group.~   "
87769|NCT01908504|"~     The purpose of this study is to determine the benefit of using positron emission tomography~     (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for~     cancer treatment. The information from the PET-CT may allow the investigators to change the~     radiation plan or the delivery of the radiation to the tumor/tumor site such as the total~     dose of radiation or the size of the area to receive further radiation. Presently the use of~     PET scans to adjust radiation therapy during radiation treatment is not standard of care and~     is being investigated in this study.~   "
87770|NCT01908491|"~     Postoperative pain management is a major problem after repair of pectus excavatum.Various~     methods of pain management have been introduced. However, the effects of continuous wound~     infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus~     surgery. Therefore, we conducted prospective randomized controlled study to compare the~     effects of IV PCA and continuous wound infusion after repair of pectus excavatum.~   "
87771|NCT01908478|"~     This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity~     Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic~     Cancer.~      Primary Objectives:~        -  Determine the maximum tolerable dose of veliparib in combination with gemcitabine and~          intensity modulated radiation therapy in patients with locally advanced pancreatic~          cancer.~        -  Determine the safety and toxicity of the combination of veliparib with gemcitabine and~          radiation therapy in patients with locally advanced pancreatic cancer~   "
87772|NCT01908465|"~     Purpose:~      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the~     H1-receptor antagonist ebastine.~      Design:~      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment~     with ebastine 20mg once daily or placebo (1:1 randomization).~   "
87773|NCT01908452|"~     Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although~     pathophysiologic theories have proposed mechanisms such as dopamine receptor~     supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid~     (GABA) depletion, and an excess of free radicals.~      Prior development of second generation antipsychotic agents, tardive movement disorders were~     widespread among neuroleptics treated patients. There were great expectations of the new~     novel drugs. Unfortunately, reports about tardive movement disturbances induced by these~     medications became more and more frequent, although it has been in use for less than two~     decades.~      A recent study demonstrated that schizophrenic and schizoaffective patients suffering from~     TD had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range,~     while those patients without TD had normal values. At the same time, some open and~     double-blind placebo-controlled, randomized clinical studies showed that vitamin B6 was very~     effective in treatment of TD.~      Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form~     of vitamin B6. Some publications reported that the finding of high vitamin B6 levels is~     consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It~     may explain the functional need for high-dose vitamin B6 supplementation in subjects with~     TD.~      Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will~     be performed. The trial will be consisted of 2 parts: the first part a single comparison~     pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD~     schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized,~     double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be~     added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients.~     Participants will be assessed at baseline and after every 2 weeks of treatment till week 12.~     Pyridoxal kinase activity will be compared between patients who positively respond to~     vitamin B6 versus non responders. In addition, PLP levels will be monitored at baseline and~     at the end of the study.~      A battery of research tools will be used for assessment of movement disorders,~     psychopathology, and side effects. The study will be performed along a period of 2 years.~   "
87774|NCT01908439|"~     The purpose of this study was to examine the validity of the measurement method based on~     observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching~     that helps to measure human WBV-induced muscular reflex latency and to compare these results~     with the latency determination obtained using the classical methods. The investigators'~     principle hypothesis is that the simple method is capable of determining the WBV induced~     reflex response latency as reliably as the complex methods described earlier.~      To achieve this goal, the investigators have averaged the electrical responses of the soleus~     muscle (sEMG and multi motor unit (MMU) potential) against the vertical force data obtained~     during all the six vibration frequencies tested in this study. The investigators have then~     combined all the averaged EMG data belonging to six different vibration frequencies to~     generate the 'cumulative averaged' sEMG and MMU for each subject. The investigators have~     also obtained the standard error for the cumulative averaged records which indicated the~     WBV-induced muscular reflex (WBV-IMR) latency.~   "
87775|NCT01908426|"~     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with~     placebo on overall survival in subjects with advanced hepatocellular carcinoma who have~     received prior sorafenib.~   "
87776|NCT01908413|"~     This is a phase I, open-label, dose-escalation study of CUDC-427 in patients with advanced~     or refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize~     proteins that prevent or interfere with cell death. The study is designed to assess the~     safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer~     activity of CUDC-427.~   "
87777|NCT01908400|"~     Mental retardation is a condition diagnosed before age 18 that includes below-average~     general intellectual function, and a lack of the skills necessary for daily living. Mental~     retardation affects about 1 - 3% of the population. There are many causes of mental~     retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells~     are used in this condition to prove its safety and efficacy .~   "
87778|NCT01908387|"~     To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment~     schedules in Japanese subjects with hematological neoplasms~   "
87779|NCT01908374|"~     The primary objective of this study is to test the effects of two different fish oil~     products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.~   "
87780|NCT01908361|"~     In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate~     clinical trials: one to recruit subacute stroke patients and another to recruit chronic~     stroke patients. The two trials will have identical study designs and interventions. The~     overall goal of this research project is to provide scientific evidence of the treatment~     effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients~     and thus to contribute to evidence-based stroke rehabilitation and translational research~     for neurorehabilitation.~   "
87781|NCT01908348|"~     This study is an open-label pilot designed to examine the dose-dependent effects of~     erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with~     type 2 diabetes mellitus will make three study visits. At each visit, the will consume an~     orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).~     Endothelial function will be assessed before and two hours after beverage consumption.~     Endothelial function will be measured as the change in pulse amplitude in response to~     reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results~     will be used to plan a randomized, placebo-controlled study.~   "
87782|NCT01908335|"~     This dose-escalating study is to evaluate the efficacy and the safety of different doses of~     a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection~     (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been~     previously treated with Interferon(IFN) by exploring the dose-effect relationship, while~     identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method~     is adopted to assess the pharmacokinetic behavior, individuals / intra-individual~     variability, and the possible factors for further study.~   "
87783|NCT01908322|"~     The study aims to investigate patient characteristics of intermediate stage hepatocellular~     carcinoma patients treated with Nexavar and their distribution to different treatment groups~     as well as determining efficacy and safety parameters.~   "
87784|NCT01908309|"~     We previously demonstrated that the slope of the relationship plotting individual iodine~     loads against contrast-induced serum creatinine changes ( the load-to-damage relationship,~     LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is~     to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two~     different contrast media using serum cystatin-C changes as the LDR dependent variable.~   "
87785|NCT01908296|"~     The objective of the study was to assess the effect of multiple-dose fluvoxamine on the~     pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E~     in the population was also evaluated.~   "
87786|NCT01908283|"~     Patients with inflammatory bowel disease are at increased risk for infections due to their~     baseline disease and the subsequent immunocompromising regimen. Streptococcus pneumoniae~     (pneumococcus) has a high mortality and morbidity, particularly in immunosuppressed~     patients. A polysaccharide vaccine covering 23 different serotypes of pneumococcus (PPSV23)~     is currently recommended to immunocompromised patients to reduce their risk of invasive~     pneumococcal infections (such as bacteremia, meningitis, or pneumonia). Its immunogenicity~     is however limited, both in magnitude and duration, even in healthy individuals. Several~     studies have investigated the immunogenicity of PPSV23 in patients with IBD and have~     reported a marked inhibitory effect of immunosuppressive therapy on vaccine responses.~      A pneumococcal conjugated vaccine (PCV) was originally developed to protect young children~     and demonstrated as highly effective and safe. PCV13 contains polysaccharides from thirteen~     different serotypes, conjugated to an inactivated diphtheria toxin, and has the capacity to~     induce both primary and memory responses. PCV also appears much more immunogenic than PPSV23~     in immunocompromised pediatric and adult patients. Whether some therapeutic regimens may~     nevertheless prevent the induction of protective responses by PCV13 is yet unknown.~      To date, no study has yet reported the immunogenicity / safety of PCV13 in adult IBD~     patients.~      Study's objectives~        -  Primary objective: evaluate the immunogenicity and safety profile of PCV13 immunization~          in IBD patients~        -  Secondary objective: evaluate the relative influence of treatment and disease on immune~          responses to PCV13 immunization~        -  Tertiary objective: evaluate the immunity/vulnerability against vaccine-preventable~          diseases (VZV, measles) in the IBD cohort of Switzerland (optional, depending on funds)~   "
87898|NCT01906827|"~     The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in~     cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function~     like fetus.Increased P-wave duration and P-wave dispersion have been reported in various~     clinical settings. The investigators hypothesized that PWD and p wave duration may affect in~     pregnancy with ICP.~   "
87791|NCT01908218|"~     Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper~     management.~      Several methods to evaluate the anatomical structures has been used during preoperative~     period for airway assessment.~      Evaluation methods are such as the Mallampati classification, mouth opening, thyromental~     distance and sternocostal distance.~      the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the~     upper lip by the lower incisor.~      The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT)~     in Korean compared to Modified Mallampati classification(MMT).~   "
87792|NCT01908205|"~     We are studying an investigational drug called intranasal oxytocin (Syntocinon®).~     Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping~     women breastfeed, but it has not been approved for use in children with ASD. However, there~     is previous research conducted that has indicated that after administration of oxytocin,~     adults with ASD demonstrated improvements in social cognition, and reduced repetitive~     behaviours and anxiety. There is also early research to suggest that children may also~     benefit in these areas. The purpose of this study is to test if oxytocin works to help~     children and adolescents with ASD.~   "
87793|NCT01908192|"~     The purpose of this study is to determine if NaBen® (sodium benzoate) is a safe and~     effective add-on treatment for schizophrenia in adolescents.~   "
87794|NCT01908179|"~     This registry study will evaluate patients with metastatic brain tumors undergoing, or~     having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical~     outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS~     treatment data, and imaging data (including anatomic and advanced imaging sequences obtained~     prior to and serially following SRS) will be archived in an online informatics platform,~     specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology~     Data Repository for Metastatic Tumors (CONDR - Mets).~   "
87795|NCT01908166|"~     This clinical trial studies ultrasound elastography in diagnosing patients with kidney or~     liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may~     be a less invasive way to check for kidney or liver solid focal lesions.~   "
87796|NCT01908153|"~     The study aims to provide a better understanding of the neural influence of eating behavior~     in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI~     brain response to pictures that signal delivery of a chocolate milkshake and to the taste~     itself. The brain response will be compared to body mass index percentile scores for each~     child to help us determine whether brain differences present in adolescents and adults with~     obesity are present in young children.~   "
87797|NCT01908140|"~     The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium~     bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic~     obstructive pulmonary disease (COPD)~   "
87798|NCT01908127|"~     The aim of this study is to evaluate the effect of Filmed modelling in comparison with~     commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years~     old children during dental practice.~   "
87799|NCT01908114|"~     The objective of the projects is to Develop and implement a Package of interventions that~     will comprise of an augmented communication and counseling strategy coupled with private~     sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach~     during the Polio campaigns followed by the evaluation of this project for acceptability,~     feasibility and effectiveness of the intervention Package.~   "
87800|NCT01908101|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     previously treated breast cancer that has spread to other places in the body. Drugs used in~     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
87801|NCT01908088|"~     Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring~     fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either~     autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is~     severe with some morbidity such as mitten hand deformity.~      The management of these patients is very difficult because no effective treatment has been~     known yet.~      The EB patients with mitten hand deformity need surgery to have a biologic dressing for~     areas of hand which is without the skin. In this study the investigators assess the safety~     of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage)~     for them.~   "
87802|NCT01908075|"~     To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at~     least equivalent in terms of exacerbation prevention to fluticasone dipropionate /~     salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following~     treatment with FP/SAL in normal clinical practice compared with patients not switched.~   "
87803|NCT01908062|"~     The purpose of this study is to learn how best to treat substance use disorders in an HIV~     clinic setting. Specifically, the purpose of this pilot study is to learn if~     extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for~     HIV-infected individuals with opioid or alcohol use disorders.~   "
87813|NCT01907932|"~     In internal medicine, assessment of spleen size on physical examination is an extremely~     important part of the overall evaluation of patients with many illnesses. Examination of the~     spleen is also one of the core competencies that the investigators expect the students and~     residents to learn as part of their training. Unfortunately, the sensitivity and specificity~     of examination of the spleen at the bedside is not very good. The investigators wish to~     determine if medical residents can be taught to use hand carried ultrasound to accurately~     assess spleen size. Doing so would make physical examination of the spleen obsolete and~     transform training objectives for medical trainees.~   "
87814|NCT01907919|"~     The purpose of this study was to compare the conventional and diode 808 nm laser-assisted~     techniques in direct pulp capping in permanent teeth .The present study was based on a~     series of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis~     of this paper was laser supported direct pulp cap-ping has proven effectiveness by its~     capacity to stimulate reparative dentine formation by pulp cells, de-contamination ability~     of irradiated areas, its ability in the fast and better haemostatic, and pain reduction.~   "
87804|NCT01908049|"~     Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with~     probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution~     and the changes in gut microbiota composition.~      SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the~     administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV~     viral load in patients after taking probiotics.~      Methods: Design: A prospective randomized open controlled double-blinded trial, to be~     performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients.~     Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells /~     ml and undetectable viral load for more than two years (22 cases) and (2) Patients with~     immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite~     4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were~     randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii~     for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide~     levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in~     plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut~     microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months.~     Immunological and clinical data. Outcome measures: quantification of bacterial translocation~     levels, markers of activity and immune recovery. Analysis: Comparison of variables before~     and after the intervention. The analysis will be performed by biological and immunological~     effectiveness.~   "
87805|NCT01908036|"~     The use of an activity monitor to determine increase or decrease of activity in patients~     suffering from chronic fatigue syndrome.~   "
87806|NCT01908023|"~     Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms~     of short-and long-term side effects may be experienced, such as physical deterioration,~     reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital,~     all out-patients undergoing post operative radiotherapy are currently offered participation~     in group exercise training sessions. The main purpose of this study is to evaluate these~     out-patient group exercise sessions.~   "
87807|NCT01908010|"~     This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20~     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's~     disease on stable doses of acetylcholinesterase inhibitors.~   "
87808|NCT01907997|"~     Systemic lidocaine infusion may improve the patients' recovery quality and chronic post~     surgical pain after robot-assisted thyroidectomy~   "
87809|NCT01907984|"~     Purpose:~      According to the proposal of the International Headache Society acute postcraniotomy~     headache (PCH) is defined as a headache of variable intensity, being most serious at the~     site of surgical intervention and developing within 7 days after craniotomy. Typically, pain~     resolves within 3 months after surgery. According to the literature the incidence of acute~     PCH during the postoperative period is 60% among patients undergoing elective craniotomies.~     No standardized international guidelines are available on the treatment of PCH to the~     present day. Treatment methods can be different based on the country and institution where~     they are used, or even physicians individually can have distinct medication regime, which~     sometimes happens to be habitual and lacks clinical evidences.~      The Department of Anesthesiology and Intensive Care Medicine at the University of Debrecen~     has been giving 100 mg diclofenac with analgesic purpose, as part of the premedication to~     neurosurgical patients for several years. It was observed that the postoperative headache~     following craniotomy was milder comparing to data published in the international literature.~     A pilot study was carried out with similar settings which found the that incidence of PCH~     was lower and less analgesics were required without any further unwanted side-effects among~     patients who received 100 mg diclofenac as part of the premedication.~      Hypothesis:~      100 mg preoperatively given diclofenac significantly reduces the incidence and severity of~     postcraniotomy headache.~   "
87810|NCT01907971|"~     Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the~     tricuspid valve, the right atrium and the right ventricle (RV).~      Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for~     the assessment of RV volume and function. To evaluate the right heart function VentriPoint~     method was designed to assess the RV in a fraction of the time, resulting in better efficacy~     and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as~     patients with systemic RV in d-transposition of the great arteries. This method uses 2~     dimensional standard ultrasound views linked to a VentriPoint Medical Systems unit. After~     acquisition, the physician identifies anatomical landmarks with dots on a number of the 2D~     ultrasound views through the heart. With a sensor (magnetic tracking system: GPS) on the~     ultrasound probe we know where the 2D plane is in 3D space. In this way the precise~     anatomical landmark is located in 3D space.~      The aim of the present study is to assess the feasibility, reliability and accuracy of the~     echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function~     in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison~     with measurements obtained by cardiac MRI.~      In addition to the right ventricle the investigators want to assess the left ventricular~     function in patients with Ebstein anomaly in this study. By using speckle tracking~     echocardiography the investigators would like to investigate on the left ventricular~     contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom~     the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of~     the right ventricle. Changes in the myocardial left ventricular structure (non compaction)~     are also described and may have negative impact on the function.~      The investigators want to analyze 25-30 patients with Ebstein anomaly including children~     starting at 11 years of age.~   "
87811|NCT01907958|"~     Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and~     Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin~     to usual practice on quality of care in hypertensive patients with Type 2 diabetes.~   "
87812|NCT01907945|"~     This study is a non-randomized double cohort study evaluating the impact of social~     network-based water treatment education on sustained household water treatment behaviors~     over 12 months of follow up. A three-session curriculum was developed on the spread of water~     borne illness, water treatment methods, and the role of social support in water treatment.~     Participants in the intervention arm will receive this curriculum in a group setting, where~     group members are self-selected members of the study participants' social networks.~     Participants in the comparison arm will receive the same curriculum taught at the individual~     household level. All participants will receive CeraMaji ceramic filters for use in household~     water treatment after participating in the three sessions. Research staff will conduct~     surveys and water quality testing over a period of 12 months to determine whether~     participants continue to use the ceramic filters. Investigators hypothesize that social~     network-based training on household water treatment will result in a higher proportion of~     households using ceramic filters at 6- and 12-months as compared to households receiving~     individual training.~   "
87816|NCT01907893|"~     The study uses a multi-site, cluster design to determine the effectiveness of an~     intervention based on a Trauma Collaborative Care (TCC) model in improving patient outcomes~     for persons with severe orthopedic trauma and enhancing both patient and provider~     satisfaction with overall care. The study will also determine the cost and~     cost-effectiveness of the intervention.~      Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus~     standard treatment will result in lower rates of the composite outcome (i.e. positive for~     poor function, depression, and/or PTSD).~      Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus~     standard treatment will result in lower levels of pain and higher rates of return to usual~     major activity and higher levels of health related quality of life. In addition, both~     primary and secondary outcomes will correlate strongly with the intermediate outcome of~     self-efficacy.~   "
87817|NCT01907880|"~     Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent~     skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological~     fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or~     bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should~     experience a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic~     acid compared with those patients who continue on intravenous pamidronate (i.e. current~     standard of care). The investigators propose that a drop in sCTX will correlate with~     improved pain, quality of life and a reduced incidence of further SREs.~   "
87818|NCT01907867|"~     This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel~     fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as~     bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF~     using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.~   "
87819|NCT01907854|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects~     with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.~   "
87820|NCT01907841|"~     Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle~     damage and changes in muscle function; this is known as exercise-induced muscle damage~     (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known~     as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as~     in various other organs.~      Therefore the purpose of this study is to:~        1. Quantify the use of IPC in recovery following EIMD.~        2. Identify any effect of IPC during recovery on muscle function~   "
87821|NCT01907828|"~     The purpose of this post market clinical investigation is to complete preliminary evaluation~     on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System~     and cardiac ablation will result in improved outcomes as compared to ablation alone in~     patients with uncontrolled hypertension being treated for Atrial Fibrillation~   "
87822|NCT01907815|"~     This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor~     GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt~     inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
87823|NCT01907802|"~     This phase I trial studies the side effects and best dose of dabrafenib in treating patients~     with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
87824|NCT01907789|"~     The goal of this clinical research study is to compare ovarian cancer screening,~     risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed~     oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied.~      Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams,~     blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal~     cancer.~      The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer.~      In RRSO, the fallopian tubes and ovaries are removed at the same time.~      In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient~     does not go through menopause. The ovaries are removed at a later date. The main goal of~     this study is to learn how many patients actually have their ovaries removed at a later~     date. Researchers also want to learn whether the removal of fallopian tubes will decrease~     the risk of ovarian cancer.~   "
87825|NCT01907776|"~     This is a single-center, randomized, double-blind, placebo-controlled, sequential group~     study. The primary objective of this study is to assess the tolerability and safety of~     single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary~     objective is to determine the systemic exposure to, and urinary elimination of, ME1100.~   "
87826|NCT01907763|"~     The objective of this study is to assess the efficacy and safety of SOTB07 in asthma~     patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral~     administration of SOTB07 200mg, 400mg, placebo for 12 weeks.~   "
87827|NCT01907750|"~     To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube~     (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.~   "
87828|NCT01907737|"~     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of~     stroke is more dramatic in low- and middle- income countries, and the scarcity of~     evidence-based rehabilitation interventions represents a major challenge to global health~     care. Upper limb weakness is frequent after stroke, but there is no universally accepted~     treatment to effectively improve hand function in patients with moderate and severe motor~     impairment. These are the patients in deepest need of rehabilitative interventions. This~     project addresses this important issue, by testing effects of a novel approach. We will~     non-invasively stimulate the brain and peripheral nerves in order to enhance effects of~     motor training aided by an electrical stimulation device in patients with moderate to severe~     hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve~     stimulation, will enhance effects of motor training to a greater extent than brain~     stimulation alone, peripheral stimulation alone, or no stimulation.~   "
87829|NCT01907724|"~     The purpose of this study is to evaluate the potential for a PK drug-drug interaction when~     IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination.~     Safety and tolerability will also be assessed.~   "
87830|NCT01907711|"~     background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional~     affect holistically to people who have the disease and current management of fatigue, pain,~     anxiety, depression and sleep disturbances present in this clinical entity is~     unsatisfactory.~      Hypothesis:~      The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.~      The investigators suggest the use of a clinical study protocol (PEC), randomized,~     placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of~     well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue,~     anxiety, depression and sleep disorders in patients diagnosed with CFS.~   "
87831|NCT01907698|"~     Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release~     during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins~     are possible involved mechanisms. The investigators propose to evaluate the effect of~     vaginal intercourse on spontaneous labour at term.~   "
87832|NCT01907685|"~     Primary Objective:~      To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the~     maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered~     sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.~      Secondary Objectives:~        -  To define the overall safety profile of the combination.~        -  To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when~          administered in combination.~        -  To evaluate anti-tumor activity of the combination.~        -  To evaluate potential predictive biomarkers.~      The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The~     objective to analyse a set of biological biomarkers in order to identify a potential~     predictive signature of efficacy for AVE8062 in combination with docetaxel.~   "
87833|NCT01907672|"~     This study aims to test directly by means of a cluster randomized controlled trial, the~     impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers,~     the main non-formal outlet for drugs locally, at community level.~   "
87834|NCT01907659|"~     This trial is a pilot study to determine the feasibility of a randomized clinical trial~     comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid~     molecular viral diagnostics, and serum procalcitonin testing to standard of care for~     directing antibiotic use in patients with non-pneumonic lower respiratory tract infection.~     The reduction in antibiotic use in those subjects randomized to the treatment algorithm~     compared to those randomized to standard care will be determined.~   "
87835|NCT01907646|"~     The objective of the study is to evaluate the impact and the outcome of bladder training~     during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant~     concurrent chemo-radiation therapy for locally advanced cervical cancer.~   "
87836|NCT01907633|"~     The purpose of this observational study is to assess the risk of out-of-hospital Sudden~     Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current~     use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of~     these medications.~   "
87837|NCT01907620|"~     The aim of this study is to explore a mechanism that could potentially explain why women~     with a pregnancy complicated by pre-eclampsia are described as having an increased risk of~     cardiovascular disease later in life.~      If the hypothesis of this study turns out to be true, that is to say that women with~     pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and~     that this difference persists after the delivery (6 months), a controlled randomized~     interventional study aiming to evaluate either therapeutic supplementation with antioxidant~     vitamins (Vit C and E) or modifications in diet could be envisaged.~   "
87838|NCT01907607|"~     The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case~     of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib~     is frequently short, and after failure with both imatinib and sunitinib, treatment remains~     controversial.~      Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al.~     2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et~     al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A,~     CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005;~     Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21~     deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are~     known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released~     from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a.~     Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and~     more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads~     to the overexpression of CINSARC genes, which in turn induce chromosome instability and~     ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in~     several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009).~     Considering our molecular data, we believed that PD-0332991 warrants clinical investigation~     in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is~     detectable by comparative genomic hybridization which is a technique highly manageable in~     the context of routine clinical care and clinical trial.~      Exploratory, one-arm, multicenter, phase II clinical trial based on twostage Simon's design~      To assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks~     (after centralized review) in patients with documented disease progression while on therapy~     with imatinib and sunitinib for unresectable and/or metastatic GIST.~      This is a multicentre single-arm Phase II study evaluating the efficacy and safety of orally~     PD-0332991, 125 mg/day, 21 days on/7 days off, in patients with documented disease~     progression while on therapy with 2nd line sunitinib for unresectable and/or metastatic~     GIST. Indeed, the usual treatment for advanced Gastrointestinal Stromal Tumors Refractory to~     Imatinib and Sunitinib is best supportive care for which outcome data are already available~     (Demetri et al., 2012; Italiano et al., 2012). Sixty three patients will be included in 10~     centres of the French Sarcoma Group over a period of 18 months of enrolment.~      Patients will be evaluated at scheduled visits in up to three study periods:~        -  Pre-treatment (PRE TT): from signature of informed consent to the first treatment by~          PD-0332991.~        -  Treatment (TT): from the first treatment by PD-0332991 to the first 28 days following~          the last PD-0332991 administration.~        -  Follow-up (FUP): after treatment discontinuation, all patients must be followed up for~          28 days after the last dose of the study drug for safety assessment (AEs and/or SAEs).~   "
87839|NCT01907594|"~     The investigators previously developed a cigarette cue extinction treatment (CET) procedure~     in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue~     Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that~     triggers it. This is accomplished through repeated exposure to that trigger, while removing~     the patient's ability to act out the conditioned response. In the present study, the trigger~     is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving.~     In the procedure the investigators have previously developed and intend to use again, the~     participant is shown a pack of his brand of choice cigarettes. The researcher removes a~     cigarette from the pack, lights it, and asks the participant to hold the cigarette without~     smoking it for 90 seconds. This procedure is repeated seven times over the course of a~     six-hour lab session. The investigators hope to boost the clinical response to smoking cue~     exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by~     pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS).~     Behavioral extinction training is a form of learning that may be modulated by NMDA receptor~     mediated glutamate transmission. The study's main hypothesis is that the partial NMDA~     receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent~     relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of~     cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking~     treatment. Development of an effective treatment strategy to enhance the effectiveness of~     NRTs would have a direct and significant positive impact on public health.~   "
87840|NCT01907581|"~     A gravity admission largest resuscitation and a poorer prognosis are expected for patients~     experiencing socio-economic vulnerability. This is the first study in France and~     investigating the field of resuscitation which will allow us to have a vision of the French~     health system and its consequences. The frequency of PTSD is expected to be more important~     in this vulnerable population itself with quality of life at discharge worse. The results of~     this study are a prerequisite for the implementation of preventive measures targeted and~     more suitable for those patients experiencing socio-economic vulnerability remediation.~   "
87841|NCT01907568|"~     Psychotic symptoms (hallucinations and delusions) are present in several psychiatric and~     neurological disorders as well as in the general population. Effective treatment strategies~     for these symptoms in all patients are lacking and treatment-response can presently not be~     predicted. To date, the exact pathophysiological mechanism of these symptoms remains~     unknown. By investigating (subtypes) of hallucinations and delusions in all populations, a~     common pathway may be found, leading to more effective treatment options. Alternatively,~     different subtypes may be associated with different pathophysiological mechanisms.~   "
87843|NCT01907542|"~     Background Stapled skin closure is frequently performed following open colectomies. However,~     its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been~     shown to be cosmetically superior and does not require removal of the sutures. But its~     association with wound infection has been questioned Aims This study aims to compare the~     outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy.~     Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis.~     Methodology Inclusion criteria: All patients who underwent elective open colectomy for~     various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the~     creation of a stoma After consenting for the trial, patients will be randomized into either~     the skin stapler or the Monocryl suture group. Randomization is performed using a computer~     model. To minimize confounders, the pre-operative preparation and antibiotics regime will be~     standardized. The closure of the fascia and the skin will also be performed by at least a~     Registrar. The wounds will then be covered with a thick sterile dressing to blind the~     patient and the research assistant. The wound will only be reviewed on the POD 3. The~     patient is scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon~     discharge. Some of the variables that will be collected for this study include: 1. Time~     taken for skin closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We~     aim to enrol 72 participants in each group. Importance/Impact to Medicine This study will~     validate the role of Monocryl suture as an effective method for skin closure following open~     colectomy. We believe Monocryl sutured closure can potentially change the practice of~     surgeons worldwide for the benefits of the patients.~   "
87844|NCT01907529|"~     The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin~     in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for~     breast cancer patients. The hypothesis of this protocol is that the combined an active~     angiogenesis agent to chemotherapy could enhance the pathological responce rate and further~     benefit breast cancer patients.~   "
87845|NCT01907516|"~     To compare compliance and satisfaction between a traditional method of blood glucose~     reporting using voicemail (control) and a novel method using cell phone /internet~     (Confidant) technology in the management of diabetic pregnant women.~   "
87846|NCT01907503|"~     To assess the prognostic value of a characteristic evaluation of gait in persons suffering~     from hip OA for subsequent indications for THR.~   "
87847|NCT01907490|"~     The purpose of the study is to evaluate the safety and tolerability of a single application~     of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.~      Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in~     Ha44 vehicle) under maximal use conditions.~   "
87848|NCT01907477|"~     The aim of the present work is to study the protein expressions profiles of neutropenic~     patients (with a high risk of invasive mycosis) who developed - versus who did not develop~     invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers~     for the diagnosis, prognosis and /or prediction of invasive mycosis.~   "
87849|NCT01907464|"~     Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass~     acquisition. A better understanding of this process would improve the medical treatment of~     bone alteration and its long-term consequences.~      160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in~     this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray~     absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly~     evaluated.~   "
87850|NCT01907451|"~     This project aims to study the effects early individualised retraining programme on walking~     ability in patients following hemiplegic stroke.~   "
87851|NCT01907438|"~     Susceptibility to breast cancer is related to the combination of genetic, hormonal and~     multiple other environmental risk factors, such as mutations in the BRCA gene and excess~     exposure to exogenous estrogen, respectively. BRCA is a nuclear protein that maintains~     genome stability, by acting as a key player in the DNA repair complex. Recently, evidence~     has emerged that BRCA mutation heterozygosis itself enhances aborted DNA repair and can~     contribute to breast cancer initiation after exposure to irradiation. In our preliminary~     results on short-term lymphocyte cultures, we found additional evidence that healthy~     heterozygous BRCA1 and BRCA2 mutation carriers have a different response to DNA damage than~     do non-carriers.~      The main aim of our ongoing project is to identify the transcriptional modulation and~     transformation potential of normal BRCA1 and BRCA2 mutation heterozygous epithelial breast~     cells following irradiation and to examine how it is affected by exposure to estrogen. Our~     hypotheses will be investigated by RNA-seq and microRNA-seq in order to identify a unique~     molecular expression profile of the estrogen exposed cells following ionizing irradiation.~      Understanding the role of BRCA heterozygosity in cell response to exposure to estrogen and~     to irradiation may facilitate the development of more appropriate diagnostic and therapeutic~     strategies for these individuals.~   "
87852|NCT01907425|"~     In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently~     balanced reciprocal translocations are revealed by foetal karyotyping, which does not always~     make it possible to determine whether the anomaly is balanced or not and does not reveal~     uniparental disomy. The presence of these chromosomal rearrangements raises a difficult~     question for genetic counselling during pregnancy because of the risk of intellectual~     deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced~     or not nature of these translocations 2) the presence or not of euchromatin in the SMC 3)~     the presence or not of uniparental disomy.~   "
87853|NCT01907412|"~     This is a research study to evaluate the effectiveness of the Family Foundations program and~     to better understand how families cope with having a new baby. The research questions~     include: What is the effectiveness of the Family Foundations program? How do families cope~     with having a new baby?~   "
87899|NCT01906814|"~     The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as~     effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated~     retinoblastoma.~   "
87900|NCT01906801|"~     The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and~     change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and~     24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of~     glucosamine in OA patients~   "
87854|NCT01907399|"~     There is a link between activation of the immune response inducing chronic inflammation and~     both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the~     mechanisms of the inflammatory cascade and the type of cells involved are not completely~     known. The aim of our project is to study the principal cell types involved in the immune~     response from a quantitative and functional point of view in obese diabetic patients versus~     obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.~      Despite possible inter-individual heterogeneity of immune cells, the fact that this work~     will be carried out by an accredited team with considerable expertise in the study of almost~     all the different types of immune cells will probably make it possible to know whether cell~     dysfunction and inflammation are associated with obesity or rather linked to insulin~     resistance. This study will be completed later by a second study on cell infiltration in~     adipose tissues in the 3 groups defined above. Better understanding of the physiopathology~     and especially the mechanisms and type of cells involved in obesity-related inflammation~     could quickly lead to the development of appropriate therapies that could act specifically~     on the cells involved and thus preclude the onset of complications.~   "
87855|NCT01907386|"~     Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen~     secondary to hypertension and atherosclerosis. Surgical treatment of AAA is increasingly~     being replaced by endovascular aneurysm repair (EVAR) using stent-grafts (SGs). However, the~     efficacy of this less invasive approach is often jeopardized by the incidence of persistent~     flow within the aneurysm, called endoleaks leading to aneurysm rupture if not properly~     detected and treated. Hence, a life long annual CT-scan surveillance is required increasing~     the cost of EVAR, exposing the patient to ionizing radiation and nephrotoxic contrast agent.~     The goal of this project is to adapt and test a new ultrasound technology called ultrasound~     elastography to improve patient follow-up after EVAR and ultimately avoid the use of~     CT-scans. This technique measures the deformation of the tissue secondary to blood pressure~     variation (quasi-static elastography) or to a shear wave generated by the ultrasound probe~     (dynamic elastography). The investigators will optimize 2 approaches to generate elastic~     maps of the AAA. One approach will be a quasi-static elastography (QSE-LSME) technique~     developed by our team giving an estimation of the deformation (strain) of the different~     components of the AAA by the blood pressure. The second is a dynamic elastography (SSWI)~     technique that will provide information on the elastic property of the AAA components.~   "
87856|NCT01907373|"~     Hypertension and hyperuricaemia are widespread conditions. There is significant overlap~     between the two conditions. Serum uric acid (SUA) is currently recognized as a risk factor~     for cardiovascular disease. Thus, at some point in their therapy, hypertensive patients with~     hyperuricaemia are likely to require concurrent treatment with anti-hypertensive and~     hypouricaemic agents. For this reason, it is important to determine whether there are any~     pharmacokinetic interactions resulting from the concomitant administration of such~     agents.Olmesartan is an angiotensin II receptor antagonist and effective and well tolerated~     in the treatment of arterial hypertension. Probenecid is a well-established hypouricaemic~     agent for the treatment of hyperuricaemia and gout.The goal of this study was to examine the~     impact of coadministration of probenecid on the pharmacokinetic parameters and tolerability~     of olmesartan in healthy volunteers.~   "
87857|NCT01907360|"~     This study will be conducted in 2 separate stages, the first in adolescents and the second~     in children. Both Stages 1 and 2 will use an adaptive, single or multiple cohort open-label,~     single-treatment, fasting design examining the pharmacokinetic (PK) effects of up to 2~     separate modified release formulations (B and C) of HLD200 (54 mg).~   "
87858|NCT01907347|"~     Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is~     associated with increased morbidity and prolonged recovery. In several clinical conditions,~     FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome.~     However, solid data to support this association in ICU patients are lacking. Only one~     retrospective study of 51 ICU patients with acute respiratory failure correlated loss of~     active cell mass with mortality. In a pilot study performed in 55 ICU patients, the~     investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38,~     P=0.03). The relation between PhA and mortality remains to be determined in ICU patients.~      Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation~     (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score~     (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of~     ICU patients. Most of these scores are time consuming and suffer some degree of~     discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery~     patients).~      PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular~     water (ECW) distribution is suggested by low PhA. PhA measurement does not require~     anamnestic parameters, body weight, and lab tests. It could easily, accurately and~     repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV~     infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis~     patients. These studies suggest that PhA may be useful in determining increased risk of~     morbidity in the ICU.~      Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could~     accurately measure FFM13 and predict survival in cancer patients. Body composition~     evaluation by CT presents great practical significance due to its routine ICU use in the~     initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has~     never been evaluated in ICU patients.~      Therefore, the investigators aim to conduct an international multicentre prospective~     observational study in ICU patients to assess the prognosis value of BIA PhA at admission,~     and to compare the performances of BIA and L3-targeted CT for FFM measurement.~   "
87859|NCT01907334|"~     To examine whether a breathing test (methacholine challenge using impulse oscillometry) can~     be used to tell the difference between two different doses of an inhaled drug, salmeterol,~     delivered by Advair in children with asthma~   "
87874|NCT01907139|"~     There are 3 specific study purposes. First, we will examine the treatment effects of RT~     combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy~     (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle~     functions, amount of arm activity in real-life situations, patient-reported outcomes of~     daily performance and quality of life, and kinematic performance. Additionally, potential~     adverse effects including fatigue, pain, and a biomarker of oxidative stress will be~     examined. Second, we will investigate if the demographical and clinical characteristics of~     stroke patients may predict the probability of achieving clinically important changes of~     treatment outcomes. Thirdly, this study will examine whether the improvements after~     treatment reach clinically important or not and assess clinimetric properties of the outcome~     measures.~   "
87901|NCT01906788|"~     The investigators' Hypothesis is that The correct timing of gametocytocidal drug in~     combination with an effective Artemisinin Combination Therapy can limit the infectiousness~     of malaria-infected individuals to less than one week after initiation of treatment~   "
87860|NCT01907321|"~     Stroke is the leading case of neurologic swallow dysfunction, or dysphagia. Post stroke~     dysphagia is associated with approximately 50% increase in the rate of pneumonia diagnoses;~     aspiration pneumonia is the most common respiratory complication in all stroke deaths,~     accounting for a three-fold increase in the 30-day post stroke death rate. The long-term~     goal of this systematic line of research is to decrease the morbidity, mortality, and health~     care costs associated with disordered airway protection following stroke.~      The overall hypothesis central to this proposal is that the ability to protect the airway is~     dependent upon a continuum of multiple behaviors, including swallowing and cough. Safe,~     efficient swallowing prevents material from entering the larynx and lower airway, and~     effective cough ejects aspirate or mucus material. Currently, only one end of the continuum,~     swallowing, is rigorously assessed in stroke patients. However, ineffective or disordered~     cough is indicative of the inability to eject aspirate material or clear mucus and~     secretions from the lower airway. Ineffective clearance and subsequent accumulation of~     material in the lower airway increases the risk of chest infection. Hence, patients at the~     greatest risk for chest infection would not only have disordered swallowing (dysphagia) but~     also disordered cough (dystussia), meaning they are more likely to aspirate material and~     then cannot effectively eject the aspirate from the airway. There is a high likelihood that~     swallowing and cough are simultaneously disordered following stroke. To date, there is a~     treatment that targets both swallowing and cough function in stroke patients.~      Expiratory muscle strength training (EMST) increases expiratory muscle strength (Baker et~     al., 2005) and there is evidence that supports its use to improve both swallow and cough~     functions in patients with Parkinson's disease (Troche et al., in press). This cross-system,~     device-driven approach to rehabilitating multiple contributors to airway protection deficits~     is highly desirable in the stroke population due to the likelihood of the co-occurrence of~     both swallow and cough disorders. To date, EMST has not been tested in stroke patients. We~     propose that by including cough in the screening, evaluation and treatment processes for~     disorders of airway protection, we will be able to better identify and treat patients most~     at risk for airway compromise and associated sequelae.~   "
87861|NCT01907308|"~     This study plans to learn more about the combination of AMG 386 and docetaxel for the~     treatment of advanced urothelial cancer. Subjects are being asked to be in this research~     study because they have advanced urothelial cancer which has progressed after treatment with~     a platinum-based therapy.~      The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a~     single agent.~   "
87862|NCT01907295|"~     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is a rare~     condition that can shorten life. Although the cause of this disease is usually unknown, in~     about 70% of heritable and 15-20% of idiopathic cases there is a change in a gene (a~     mutation) that controls how blood vessels grow and function. The gene is called bone~     morphogenetic protein type receptor 2 (BMPR2). Although mutations in BMPR2 are a risk factor~     for PAH, not everyone with a mutation gets the disease. Additional genetic and environmental~     factors are likely to contribute. The investigators suspect that mutations in other genes~     are responsible for some cases of PAH. In this study the investigators aim to recruit all~     patients with PAH and some of their relatives and follow them up for several years. The~     investigators hope to discover new mutations for this disease and to determine what factors~     lead to poor outcome, and to understand what triggers disease in patients with mutations.~      Who can participate? Adults with PAH, their relatives and controls (one off blood sample)~   "
87863|NCT01907282|"~     Preventing psychotic disorders such as schizophrenia and associated functional disability~     could relieve an enormous burden of personal and family suffering and economic losses to~     society. This project aims to conduct a pilot randomized trial to determine the efficacy of~     a family-focused treatment in comparison with treatment-as-usual in enhancing functional~     outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in~     transitional age youth with prodromal symptoms. The results of this study will be crucial~     for the development of cost-effective, evidence-based psychosocial approaches to psychosis~     prevention and thus will have major implications for public health.~   "
87864|NCT01907269|"~     The purpose of this study is to conduct a randomized trial of a tailored intervention~     designed to provide personalized feedback regarding patients' risk of subsequent fractures,~     customized information regarding osteoporosis care, and messaging to activate patients to~     become more engaged in improving osteoporosis treatment and doctor-patient communication.~     This novel content will use story-telling delivered via the Internet and digital video~     discs (DVDs). The content will be uniquely tailored to each person based on barriers to~     care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this~     intervention to determine differences in post-intervention rates of osteoporosis care~     between two randomization arms.~      We hypothesize that participants randomized to the intervention arm, compared to those~     randomized to a control arm, will receive more osteoporosis care at 6 months~     post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis~     therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral~     density (BMD) testing.~   "
87865|NCT01907256|"~     There was not any randomize trial to show what is the best type of incision in open~     rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual~     Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step~     incisions.~   "
87866|NCT01907243|"~     Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft~     is the gold standard. More recently, the spreader flap technique has been espoused as an~     alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a~     randomized trial setting.~   "
87867|NCT01907230|"~     Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in~     hepatitis B inactive carriers and patients with past HBV infection~   "
87868|NCT01907217|"~     Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and~     is often life-saving. There are concerns, however, that standard bitemporal ECT (the most~     commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical~     trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT~     but have much less cognitive side-effects.~      The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right~     unilateral ECT is as effective as (i.e. not inferior to) standard (1.5 x ST) bitemporal ECT~     for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the~     treatment course.~   "
87869|NCT01907204|"~     The purpose of this study is to determine whether inhaled corticosteroid (specially~     nebulized) could be a good alternative to oral corticosteroid and whether they are effective~     in the treatment of sinusitis~   "
87870|NCT01907191|"~     This study is being undertaken to compare the pain control using either bupivacaine versus~     liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up~     to 72 hours while regular bupivacaine can provide pain relief up to 12 hours~   "
87871|NCT01907178|"~     To investigate postoperative pain management in patients undergoing knee or hip replacement~     while they are in the hospital and following discharge to their home. Additionally, sample~     questions will be asked prior to surgery to predict patient's postoperative pain experience.~   "
87875|NCT01907126|"~     The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated~     women with lifetime interpersonal violence who are 6-10 weeks away from release to~     demonstrate the feasibility and acceptability of the proposed recruitment methods and~     research design, of the intervention training methods, of delivering the enhanced Women's~     Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators~     will also examine 95% confidence intervals around differences between the proposed~     intervention and a dose-matched control condition (Nutrition Program), for the following~     outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex~     occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal~     violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days~     (secondary); and increased affect management and social support (including effectiveness in~     obtaining substance use, mental health treatment and other resources) (tertiary).~   "
87876|NCT01907113|"~     Assessment of the effect of normal and impaired kidney function on the pharmacokinetics,~     pharmacodynamics and safety of BI 10773~   "
87877|NCT01907100|"~     This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of~     nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib~     (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of~     patients with unresectable malignant pleural mesothelioma.~   "
87878|NCT01907087|"~     The purpose of this study is to determine whether BMN 190 is safe and effective in the~     treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)~     disease.~   "
87879|NCT01907074|"~     As the treatments for liver disease and the availability of liver transplantation have~     progressed, the number of patients with end stage liver disease continues to increase. This~     has increased the need to risk-stratify patients with cirrhosis to better direct their~     treatments and provide an accurate prognosis for their outcomes. The traditional assessment~     of the liver patient has been limited to imaging, static measures of liver function tests~     and liver biopsy. This protocol is designed to increase the spectrum of tests in the~     evaluation of the patient with end stage liver disease.~   "
87880|NCT01907061|"~     Trial to test the effect of administering N-acetylcysteine on cytokines and markers of~     oxidant stress and the incidence of acute renal failure post liver tranplant~   "
87881|NCT01907048|"~     This cross-sectional epidemiologic study will measure physician and patient awareness and~     understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert~     card.~   "
87882|NCT01907035|"~     OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral~     intervention by psychologists in the field of primary care in anxiety-depressive patients,~     mild to moderate, compared with usual care.~      DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups.~     SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild /~     moderate, belonging to the target population of 41 doctors from several health centers.~     INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a~     standardized program of cognitive behavioral therapy applied by psychologists, by the usual~     treatment or control group, which will be standard care. MEASUREMENTS: The main result will~     be changes in general health scores of the SF-36. It will also measure the change in~     frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and~     BDI at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and~     health services.~      ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in~     both groups at the end of the 12 month follow up. Estimates of the effect attributable to~     the intervention by the difference in those changes, adjusting in addition to the baseline,~     the possible confounding covariates or effect modifiers of the intervention, using~     longitudinal mixed-effects models.~   "
87883|NCT01907022|"~     Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used~     to modulate the neural pathways contributing to the perception and distress of phantom~     sounds.~   "
87884|NCT01907009|"~     The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly~     complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen~     blockade) is common place. Following the failure of such an approach, several strategies may~     be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is~     being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that~     this is viewed by many as the standard of care for fit patients.~      Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but~     to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase~     I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows~     that median overall survival is 22 months, which is higher than the median survival rate of~     19 months for Docetaxel~      Data from a previous phase I study has proved the successful administration of higher doses~     of IV Melphalan in combination with autologous blood infusion in patients with~     Castration-resistant prostate cancer.~      Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan,~     however slow platelet recovery meant longer periods of platelet transfusion. For this study~     we intend to assess the efficacy of an intensified intravenous melphalan with autologous~     whole blood stem cell transplantation over three treatment cycles.~      39 patients will be enrolled over a 3 year period and at least 17 patients need to survive~     progression free at least 6-months for this study to be considered positive.~      Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:~      MELPHALAN and LENOGRASTIM for 3 cycles alternately.~   "
87885|NCT01906996|"~     There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the~     proximal row carpectomy and the four corner fusion. They are used to reduce pain and to~     maintain the mobility. In previous studies are shown that the proximal row carpectomy shows~     a better mobility of the wrist postoperatively, whereas the four corner fusion has lower~     progression of radiocarpale osteoarthritis.~      The purpose of this study is to compare the clinical, radiological and subjective outcomes~     after the treatment with a proximal row carpectomy or a four corner fusion.~   "
87997|NCT01905514|"~     Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic~     rejection and graft failure and it is regarded as a preventable cause of graft loss after~     solid organ transplantation. The purpose of this study is to evaluate whether mobile~     application for drug medication can enhance the drug adherence rate.~   "
87886|NCT01906983|"~     The true incidence of thrombosis in the portal venous system after blunt splenic trauma is~     unknown and has not been elucidated in the medical literature. The investigators hypothesize~     that this entity is more common than previously suspected. Consequences of missing this~     diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and~     portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment~     with anticoagulation and avoidance of these complications. In a prospective fashion, doppler~     ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up~     who have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in~     patients initially diagnosed with thrombosis in the portal venous system on their 3 month~     ultrasound. The investigators will attempt to identify risk factors in this trauma~     population that would facilitate an early screening protocol.~   "
87887|NCT01906970|"~     A single centre, clinical experimental study. Every subject will undergo clamp experiments,~     where a clamp device (ClampArt®) measures and controls the blood glucose concentration after~     administration of marketed insulin products.~   "
87888|NCT01906957|"~     The aim of study is to investigate the impact of two different training modalities (high~     intensity interval training (HIIT) versus moderate intensity continuous exercise training~     (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness~     in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart~     failure. The investigators hypothesized that HIIT modality will lead to a larger improvement~     in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke~     volume) and cognitive performance at rest and during submaximal exercise. The primary~     endpoint will be the improvement in cognitive performance.~   "
87889|NCT01906944|"~     Patients with chronic abdominal pain- with a component of abdominal wall pain- are often~     treated with trigger point injections. This study will help to determine if a block within~     the transversus abdominis plane (TAP) will provide superior analgesic benefit to a trigger~     point injection as therapy for these patients.~   "
87890|NCT01906931|"~     People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to~     increase oxygen levels in the blood during daily activities. The best way of delivering this~     type of oxygen has not been established. The aim of this study is to compare two devices for~     delivering oxygen in people with interstitial lung disease - the traditional method using~     portable cylinders and a newer method using a portable concentrator. The investigators~     hypothesise that oxygen levels during exercise will be significantly higher when using a~     portable cylinder, but this difference will be small.~   "
87891|NCT01906918|"~     Strategies for myocardial protection during open heart surgeries are desired. Several~     experimental studies have shown beneficial effects of remote ischemic preconditioning~     (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate~     molecular mechanisms involved with RIPC on myocardium of patients underwent open heart~     surgeries.~   "
87892|NCT01906905|"~     Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for~     depression and has been investigated for the treatment of psychiatric illness for over 15~     years. There is now established evidence indicating TMS is an effective treatment for~     depression. However, the effectiveness of TMS varies between people, thus requiring further~     research to investigate its optimal application. Investigators want to compare the~     effectiveness of different forms of TMS, given with differing stimulation settings to the~     right or left side of the brain that has been associated with depression. This could~     potentially help clinicians in the future to improve the prescription of TMS as a treatment~     for depression.~   "
87893|NCT01906892|"~     This study explores the hypothesis that mental health service users, their carers and~     musicians can - through the creative act of music learning and performing - mutually enhance~     wellbeing through the development of more meaningful and resilient lives. The project seeks~     to explore three interconnected issues: (i) the extent to which music learning and~     performing provides a forum for 'mutual recovery' among adult mental health service users,~     their formal/informal carers, and musicians, (ii) the characteristic features of 'mutual~     recovery' through music, and (iii) the underlying mechanisms of such 'mutual recovery'.~      The study will consist of three different stages. Stages 1 and 2 will examine the effect of~     a variety of group activities - including participatory music, listening to live music,~     listening to recorded music and a non-music control - on psychological scales, saliva~     samples of stress hormones and cytokines, and subjective experience to see which provide the~     most relaxing, sociable and supportive environments for mutual recovery. Stage 3 will~     explore the impact of musical interventions over longer periods of time.~      A systematic review we have just carried out has revealed a major gap in research comparing~     different music interventions and testing the effects of different lengths of interventions.~     As a result, our study should help us answer the following questions:~        -  Which aspect(s) of music can contribute to mutual recovery?~        -  Do carers, patients and musicians all respond to the same activities, or do some~          musical activities suit certain groups more than others?~        -  Do carers, patients and musicians all recover at the same rate?~        -  What length of intervention is most effective?~      If certain interventions are found to produce stronger results than others, these results~     could help guide community groups and healthcare settings in their design of music~     activities and have implications for the spending of arts-in-health budgets.~   "
87894|NCT01906879|"~     Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth~     quadruple therapy or triple therapy for 14 days remains unknown.~      Therefore, we aim to compare the eradication rates and long term re-infection rates of~     quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple~     therapy for 14 days.~      Methods: This will be a multi-center, open labeled, randomized control trial Patients: H.~     pylori infected patients who have willingness to receive eradication therapy~      Testing for H. pylori infection Before First Line Ttreatment~      (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT~     will be considered as H. pylori infected~      After First Line Treatment: C13-Urea breath test will be used to assess the existence of H.~     pylori 6-8 weeks after first line therapy.~      Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H.~     pylori 1 year after eradication therapy~   "
87895|NCT01906866|"~     The purpose of this study is to establish the efficacy and safety of Circadin in children~     with neurodevelopmental disorders and to determine the dose, this randomized,~     placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week~     treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and~     additional parameters in children with neurodevelopmental disabilities. The efficacy and~     safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period~     of 13 weeks.~   "
87896|NCT01906853|"~     1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a~          reduction in measures of allergy and infection in the first 12 months of life.~        2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by~          comparing markers of immunity between the BCG and non-BCG groups.~   "
87902|NCT01906775|"~     Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen~     ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can~     increase mortality. This study aimed to determine the role of back-up pacing-induced VT~     (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing~     by programming the pacing output to a sub-threshold level for ineffective pacing.~   "
87903|NCT01906762|"~     Kidney stone is one of the most common diseases in every human society and also Iran. What~     is normally used to treat renal colic pain is Intravenous Opioid with a variety of side~     effects including hypotension, respiratory depression and apnea, nausea and vomiting.~     Regarding less complications of Intravenous Acetaminophen, we aimed to compare it with~     Intravenous Morphine in management of renal colic pain.~   "
87904|NCT01906749|"~     Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine~     (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years~     after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the~     specified combined endpoint from 16% to 7-8% at a 2-years follow-up.~   "
87905|NCT01906723|"~     Unstrained ambulation is the main goal of gait rehabilitation for preventing fatigue and~     increasing functionality in patients with gait deficiencies. The Up n' Free (Easy Walking)~     is a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to~     provide the user with independence, safety, and endurance. It allows for easy transfer from~     sitting to standing position and stabilizes the pelvis, allowing for free movement of the~     hands. The effectiveness of the Up n' Free trainer in increasing the patient's functionality~     at the hospital or at home has not been quantified. We therefore aim to evaluate~     effectiveness of the gait trainer in increasing the functionality and spatiotemporal~     parameters of gait of 4 patients.~   "
87906|NCT01906710|"~     The purpose of this study is to determine whether a hospital pharmacy team (pharmacy~     technicians and pharmacists) together with (recently admitted) patients are able to diminish~     the number of drug related problems including adverse drug events, made before, during and~     after admissions resulting in reductions of re-hospitalizations and costs.~   "
87907|NCT01906697|"~     The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF)~     turbinoplasty with middle turbinate resection and medialization~   "
87908|NCT01906684|"~     This study will determine changes in: 1) the immune activity, characterized as the~     immunorepertoire; 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient~     reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis~     who are treated with Acthar Gel.~   "
87909|NCT01906671|"~     Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The~     patients undergo four phases of treatment, finishing with a late maintenance phase in which~     6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity~     in this phase is associated with increased risk of relapse. Excessive variation in the~     bioavailability of 6-mercaptopurine has been observed which can cause both risks of~     undertreatment/relapse as well as overtreatment with severe side effects.~      In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have~     been pursued. Nonetheless variation in bioavailability remains a problem.~      Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of~     6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate~     dosing and getting the children to swallow the tablets have been a widespread problem,~     forcing the caregivers to divide or crush the tablets as well as having to administer~     different dosages over 2-3 days. Due to these problems, an oral liquid formulation of~     6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been~     tested on healthy adult volunteers, and not on the target group, childhood patients. This~     project will assess the bioavailability and plasma kinetics of oral liquid and tablet~     formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.~      The investigators hypothesize to observe comparable plasma kinetics, in children with acute~     lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral~     liquid formulation, as previously observed in healthy adults.~   "
87910|NCT01906658|"~     This 8-week randomized, open-label evaluation will examine the acute safety and tolerability~     of 4 different dosing regimens of Acthar to inform dose selection for future studies of~     Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate~     the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help~     design future studies.~      This study will enroll up to 40 patients and include an optional 28-week open-label~     extension period plus a 3-week treatment taper and 1-week follow up period. After completion~     of Week 8, patients enrolled in a treatment group that is considered safe and tolerable at~     that time have the option to continue into the open-label extension period. A 3-week~     treatment taper and a follow-up visit are planned for all patients enrolled in the study,~     beginning either at Week 8 or at Week 36 if a patient continues into the optional open-label~     extension period.~   "
87919|NCT01906541|"~     X-linked chronic granulomatous disease (X-CGD) is a rare inherited immune defect, which is~     caused by the inability of phagocytic cells to produce reactive oxygen species due to a~     defect in the gp91phox subunit of the NADPH oxidase complex. X-CGD patients suffer from~     recurrent and life-threatening infections and severe hyperinflammatory complications.~      The only curative treatment for X-CGD is allogenic hematopoietic stem cell transplantation,~     but this procedure implies severe risks and many patients lack an appropriate donor.~     Therefore alternative curative approaches are urgently needed. In this study, patients will~     be treated with gene-corrected autologous CD34+ cells, using a SIN gammaretroviral vector~     for ex-vivo gene-therapy.~   "
87920|NCT01906528|"~     Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous~     studies have shown that males and females respond differently to this kind of drug. Our~     hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant)~     than females, meaning that males need a lower blood concentration of the drug than females~     in order to obtain a given effect.~   "
88006|NCT01905397|"~     The purpose of this study is to compare the rate of surgical site infection between~     traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days~     after surgery and at the first clinic visit after surgery.~   "
87911|NCT01906645|"~     The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality~     improvement project being implemented at OHSU to improve the transition from hospital to~     home for uninsured and Medicaid patients admitted to general medicine and cardiology wards~     at OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge~     phone follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an~     effective way to assure timely, safe, and effective follow-up care for uninsured and~     underinsured hospitalized patients. Most uninsured patients have no source for primary care,~     and many have limited social support, complex medical problems, and are prescribed many~     medications. Patients are frequently discharged without any coordinated plan for follow up.~     Based on a needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a~     quality improvement program that will include three major components: 1) a care transitions~     RN advocate who will see patients in the hospital and after discharge, 2) a pharmacy~     consultation and 30 days of medications post-discharge, 3) linkages with primary care~     medical homes, including payment for primary care for uninsured patients who lack a usual~     source of care, and 4) monthly meetings that serve as a platform for continuous quality~     improvement. In order to measure the success of our program, investigators will track~     patient utilization, sociodemographic factors, and patient factors including satisfaction,~     activation, and self-reported health status. To be included patients must be uninsured, have~     Oregon Medicaid, or be low income (200% or less of federal poverty level) Medicare~     recipients, and live within Multnomah, Washington and Clackamas Counties in Oregon.~   "
87912|NCT01906632|"~     To investigate gene expression profile and immunological associated analysis relating to~     immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.~   "
87913|NCT01906619|"~     Febrile seizures occur in 2-5% of the population and are typically limited to children~     between 3 months and 5 years-of-age. The pathophysiological link between increased body~     temperature and increased seizure susceptibility is unsolved in humans. In a mouse model it~     has been shown that young animals had a tendency to hyperventilate thereby causing~     intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. This effect~     was not observed in older animals. Redressing the pCO2 (carbon dioxide partial pressure) by~     breathing carbon dioxide enriched air instantly stopped the seizures.~      In this study the investigators want to investigate the respiratory physiology in children~     with febrile seizures and compare it to children who have fever but did not have febrile~     seizures.~      The investigators hypothesize that in children with febrile seizures the rising body~     temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent~     drop in pCO2 levels.~      This study could provide the basic physiological data for an interventional trial to test~     the efficacy of carbon dioxide inhalation to interrupt febrile seizures.~   "
87914|NCT01906606|"~     The purpose of the current study involves the development, implementation and evaluation of~     a parenting program to target maternal well-being and child health, growth and development~     in Lira, Uganda. The current study aims to address maternal care within a parenting program~     as well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation~     through peer-support, practice and problem-solving. Outcomes include child health, growth~     and development, maternal mental health, mother-child interactions, and maternal-spousal~     relations.~      We hypothesize that:~        1. Children of parents who attend the parenting program will have better health, height~          and cognitive/language development at post-test, than children whose parents did not~          have the opportunity to attend parenting sessions.~        2. Parents who attend the parenting program will have more knowledge about child~          development and provide more home stimulation, dietary diversity and preventive health~          practices than parents who do not have the opportunity to attend parenting sessions.~        3. Mothers who attend the parenting program will have improved well-being compared to~          mothers who do not have the opportunity to attend parenting sessions.~   "
87915|NCT01906593|"~     To monitor the safety of Beijing Tiantan Biological's influenza vaccine in elderly through~     Adverse Events Following Immunization Surveillance System of China.~      The hypothesis is that there is no significant difference in the occurrence of adverse~     events among influenza vaccines manufactured by independent companies.~   "
87916|NCT01906580|"~     Currently, seven medications are approved for the treatment of hepatitis B: two formulations~     of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic~     hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon~     alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide~     analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg）~     positive patients with high serum hepatitis B virus DNA levels, the rates of virological~     response are poor. And antiviral drug resistance is a major limiting factor to the success~     of nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an~     oral agent with a high genetic barrier to resistance might be superior to standard current~     monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater~     decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg~     sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in~     achieving higher virological response, histological improvement and normalisation of ALT.~     Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance.~     This study is aimed to investigate the efficacy of combination or sequential therapy using~     peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.~   "
87917|NCT01906567|"~     The purpose of this study, to investigate whether severity of preeclampsia is associated~     with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood,~     and maternal hair.~   "
87918|NCT01906554|"~     Eggs contain an essential nutrient called choline and adequate levels of choline are~     required for good health. Studies in mice have demonstrated that high levels of choline may~     increase risk of heart disease through a process that involves the breakdown of choline by~     gut bacteria. Previous research did not show that human consumption of eggs increases risk~     of heart disease. This study is designed to investigate whether the number of eggs in the~     diet affects blood and urine markers for heart disease.~   "
88007|NCT01905384|"~     The purpose of this study is to compare the rate of long-term stent failure, defined as need~     for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of~     inoperable malignant distal bile duct obstruction.~   "
87921|NCT01906515|"~     Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time~     trending of changes or lack of changes in hemoglobin, which has the potential to alter red~     blood cell (RBC) transfusion decision making. The objective of this study was to evaluate~     the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The~     investigators hypothesize that SpHb will improve blood transfusion practice in the for of~     change the number of blood unit per patient and improve the outcome regards the time to take~     decision of transfusion trigger.~   "
87922|NCT01906502|"~     A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now~     on healthy volunteers and patients with glaucoma. However, healthy subjects were much~     younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish~     database was almost twice higher than the number of healthy subjects. As it is generally~     accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in~     young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy~     subjects. Furthermore, improving our knowledge of the healthy 24-hour IOP pattern in~     comparison to glaucoma profiles would be beneficial for management of glaucoma.~   "
87923|NCT01906489|"~     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease~     (pre-dialysis) with anemia with dosing for 20 weeks.~   "
87924|NCT01906476|"~     This is a randomized, controlled trial comparing telephone-cognitive behavior therapy~     (T-CBT) with a therapist to a Stepped Care intervention for depression treatment (iCBT~     with support from a telephone coach with the possibility of being stepped up to receiving~     T-CBT with a therapist).~   "
87925|NCT01906463|"~     This study should also raise questions about the interest and feasibility of establishing a~     permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected~     doubling of the population of persons aged over 60 years and the foreseeable changes in~     lifestyle will increase the burden of this disease, in particular since the region is marked~     by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In~     addition, this study will provide epidemiological information on CVA, its risk factors and~     management, which are non-existent for the department of French Guyana where the health~     environment is manifestly insufficient. These data should make it possible to better~     evaluate the resources available and the healthcare needs in Guyana.~   "
87926|NCT01906450|"~     Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections~     with relatively easy treatment and preventive features. The present study is aimed to~     determine if treating human individuals with chronic periodontitis, along with the use of~     antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if~     severity of periodontitis could be associated with a raise of systemic inflammatory~     biomarkers on baseline.~   "
87927|NCT01906437|"~     A study to test the effectiveness of an investigational imaging technique for detecting~     cardiac injury after the administration of certain chemotherapies, such as doxorubicin.~     Investigational means that the imaging technique is still being studied and that research~     doctors are trying to find out more about it- such as whether the technique can detect lower~     levels of cardiac injury after treatment with doxorubicin. It also means that the FDA (the~     U.S. Food and Drug Administration) has not yet approved the use of gadolinium or approved~     the use of CMR studies for detection of cardiac toxicity after doxorubicin.~      The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been~     associated with the development of heart failure in some patients. Cardiac Magnetic~     Resonance (CMR) is a type of MRI scan that uses a magnetic field to produce pictures of the~     heart. The CMR scan has been used in other studies and information from those other research~     studies suggest that this imaging technique may help to better detect differences in the~     structure of the heart muscle after treatment with doxorubicin. In this research study, we~     hope that we can better detect changes in the heart muscle after treatment with doxorubicin~     with a CMR scan in the hopes that cardiac injury can be detected and treated earlier to~     ultimately prevent the possible development of heart failure~   "
87928|NCT01906424|"~     This study is to determine if non-invasive electrical stimulation of the spinal cord can~     help improve hand and arm function in people with paralysis who suffered a cervical spinal~     cord injury.~   "
87929|NCT01906411|"~     The broad aim of the study is to obtain a better understanding of alterations in mesolimbic~     reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in~     obesity.~      This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward~     tasks and the modulation of the dopamine level by dopamine depletion.~   "
87930|NCT01906398|"~     The purpose of the study is to obtain pilot data on safety and efficacy of ketogenic diet~     (KD) as adjunctive treatment of adults with refractory epilepsy. This will be an open label~     study comparing seizure frequency during 4 months of prospective baseline observation period~     with seizure frequency during 4 months of add-on KD treatment. 18-65 year old men and women~     with refractory epilepsy, defined as seizures persisting in spite of past/present treatments~     with ≥ 3 AEDs, with seizure frequency of ≥ 0.5/month, will be evaluated. Subjects with both~     primary generalized and localization-related epilepsy (PGE, LRE) will be recruited. Subjects~     will have had epilepsy for at least 2 years prior to enrollment. Following initial~     screening, subjects will be observed for 4 months, with no change in AEDs except when deemed~     necessary by the patient's neurologist according to standard clinical care. Patients will~     then start ketogenic diet. Evaluations will include seizure frequency using a seizure diary,~     adverse events, treatment compliance using urine and plasma ketone levels. Quality of life~     will be evaluated with a standardized questionnaire of Quality Of Life In patients with~     Epilepsy, QOLIE-31-P. Level of alertness will be evaluated with Epworth Sleepiness Scale.~     These questionnaires will be administered at each visit.~   "
87965|NCT01905943|"~     This multicenter, open-label, single-arm study will evaluate the safety and efficacy of~     obinutuzumab alone or in combination with chemotherapy in participants with previously~     untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). Participants will~     receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with~     chemotherapy at the investigator's discretion. Each participant will be followed until 30~     months after the last participant has been enrolled. Total length of the study is~     anticipated to be approximately 5 years.~   "
87931|NCT01906385|"~     While radiation is an essential component to the treatment of glioblastoma, it's use is~     limited due to toxicity when higher doses are attempted. Rhenium is a compund which releases~     radiation in small particles that are absorbed after only a fraction of an inch. This~     limited penetration means that high doses potentially can be given without the toxicity of~     other forms of radiation. In order for the radiaiton to be retained within the tumor, it has~     been packaged in microscopic fat like particles termed nanoliposomes. These facilitate the~     uptake of the radiation particles by the tumor. In order to better characterize this form of~     radiation therapy, it is being administered in patients who have failed other forms of~     therapy for glioblastoma. The treatment is administered by tubing inserted into the center~     of the tumor in the operating room. There are two portionms to this study. The first~     involves progressively increasing doses until the most tolerable dose can be identified. The~     second portion of the study involves a larger number of patients being treated at the~     determined most tolerable dose to better evalaute how well the treatment works.~   "
87932|NCT01906372|"~     The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH~     Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is~     associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness~     without a rash. The study doctors want to evaluate whether ACTH Gel will improve the~     symptoms of this disease. This drug is approved by the Food and Drug Administration (FDA)~     for dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment~     for myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for~     ACTH gel use.~   "
87933|NCT01906359|"~     Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It~     is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is~     also one of the risk factors for cardiovascular disease (CVD). This disease is due to~     insulin resistance and/or deficiency as well as increased hepatic glucose output. According~     to the Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for~     adults aged 30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary~     composition may affect insulin sensitivity, postprandial triacylglycerol concentration and~     the risk of T2DM. The role of dietary fats in T2DM is of particular interest and has been~     clinically studied for many decades. The type of fat we ingest every day consists of~     different types of fatty acids and different degree of saturation, which in turn influence~     glucose metabolism by altering cell membrane function, enzyme activity, insulin signalling~     and gene expression. Previous studies demonstrated that interesterification of dietary fat~     alter postprandial lipaemia. Saturated fat such as palm olein has been reported to display~     lower postprandial lipaemia after interesterification. Changing the structure of~     triacylglycerol (TAG) alters the physical properties of dietary fat which affects~     digestibility, metabolism and atherogenicity. A recent study conducted by Sanders and~     co-workers demonstrated reduced levels of plasma glucose-dependent insulinotropic~     polypeptide (GIP) following both the lard and interesterified palm olein (IPO) compared with~     the palm olein (PO) and high oleic sunflower oil (HOS) diets in healthy subjects. The GIP~     and glucagon-like peptide-1 (GLP-1) are major players in the modulation of postprandial~     insulin secretion by the pancreas. Although GIP secretion in response to meals is normal in~     patients with Type 2 diabetes mellitus (T2DM), GIP induced secretion of insulin is defective~     in diabetes. This is observed to be predominantly a defective stimulation of the late phase~     of insulin response (20-120 minutes). The effect of IPO on GIP may be exaggerated in T2DM~     patients with impaired insulin sensitivity. Hence, IPO may change the concentrations of gut~     hormones, postprandial lipaemia, insulinaemic response and CVD related haemostatic markers.~   "
87934|NCT01906346|"~     Cocaine-use disorders continue to be a significant public health concern, yet no effective~     medications have been identified. The goal of this study is to establish a research platform~     for the development of medications for treatment of cocaine abuse and dependence. This study~     will incorporate self-administration procedures and a non-drug alternative reinforcer, which~     is hypothesized to reduce the reinforcing effects of cocaine.~   "
87935|NCT01906333|"~     There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid,~     IMCL) markedly increases the risk of metabolic complications, including insulin resistance~     and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively~     taking up FFAs when the availability is high, thereby leading to an increased storage. To~     test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise,~     and monitor intramuscular lipid content.~      Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on~     skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid~     content will be investigated at baseline and after an exercise protocol and again after a~     four-hour recovery period from exercise, once in a condition with high FFA concentration,~     once with low FFA concentration. To achieve high- versus low FFA concentrations, an exercise~     protocol was chosen and participants had to perform this protocol once with a glucose~     supplementation and once without.~      Skeletal muscle lipid content will be determined before, directly after exercise and 4 h~     post exercise (from muscle biopsies) with or without glucose supplementation.~   "
87936|NCT01906320|"~     The aim is to test the hypothesis that high-resistance training for 8 weeks, following the~     recommendations for healthy adolescents, is capable of eliciting increases in muscle~     strength, agility, skeletal muscle mass, and functional capacity without losing weight, body~     mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we~     hypothesize that the effects produced by the high-resistance training program will be~     maintained 4 weeks following the completion of the training program.~   "
87937|NCT01906307|"~     Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney~     function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the~     gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a~     vasoconstrictor that may restore proper circulation and kidney function in patients with~     HRS.~   "
87938|NCT01906294|"~     This observation plan outlines the approach to build a diabetes registry to collect data on~     daily routine of treatment of Type 2 Diabetes Mellitus.~   "
87939|NCT01906281|"~     Adipocytokines play an important role in joint inflammation in patients with knee~     osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive.~     Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more~     prevalent in these patients.~   "
87940|NCT01906268|"~     The objective of this project is to test the combination of active or placebo Attentional~     Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients~     resistant to antidepressants.~   "
87981|NCT01905735|"~     the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic~     medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.~   "
88020|NCT01905202|"~     Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be~     safe and well tolerated. Further, pH control will be evaluated in the distal esophageal~     mucosa and just below the squamocolumnar junction.~   "
87941|NCT01906255|"~     This is an observational nested case control study among pre-exposure prophylaxis (PrEP)~     observational or clinical studies. The study will assess level of adherence as measured by~     drug level and its relationship to renal and bone adverse events, risk of seroconversion,~     and resistance development in subjects taking emtricitabine (FTC)/tenofovir disoproxil~     fumarate (TDF) (Truvada®) for PrEP.~      In the protocols of the parent PrEP observational or clinical studies, participants will~     have follow-up visits on average every 3 months for evaluation of adherence, HIV-1 status,~     renal and bone adverse events, and seroconversion. Adherence will be determined by the~     specific FTC/TDF drug level measurement(s) outlined in the parent protocol.~      There are two case definitions: a) One-hundred-fifty subjects who seroconvert (become HIV-1~     positive) and b) any subjects who either develop a protocol-defined renal adverse event~     (stratified by Division of AIDS [DAIDS] grading) or have a skeletal adverse event (any~     fracture) while taking FTC/TDF for PrEP.~      Among the estimated 7,000 subjects from Truvada for PrEP observational and clinical studies~     all cases, defined as subjects who seroconvert and/or develop either renal or skeletal~     adverse events, will be identified. Randomly chosen controls on Truvada will be selected in~     a 3:1 ratio, from the same site, with a similar treatment duration.~   "
87942|NCT01906242|"~     Adequate denture hygiene is important to patient's oral health maintenance in particular~     because of Candida albicans, responsible for the development of denture stomatitis. The aim~     of this study is to conduct a randomized controlled trial seeking for the best hygiene~     protocols to be used in removable denture wearers. The null hypothesis tested is that there~     will be no difference among the denture hygiene protocols tested.~   "
87943|NCT01906229|"~     Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation,~     that may be caused by a variety of insults with pulmonary and systemic infectious disease~     being the most common predisposing factor. Sepsis, on the other hand, represents the~     systemic inflammatory response to an invading pathogen, which may inflict damage upon the~     host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that~     have a high mortality, and both diseases involve a complex interplay of different~     inflammatory mediators and cell types. It has been suggested that locally released~     inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering~     systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead~     to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However,~     the time course and the possible pathways for this transmission of disease have yet to be~     established.~      Investigators hypothesize that:~        1. Primary systemic inflammation is followed by a secondary pulmonary inflammatory~          response~        2. Primary pulmonary inflammation is followed by a secondary systemic inflammatory~          response~        3. Both primary and secondary inflammatory responses are characterized by the appearance~          of pro-inflammatory cytokines, inflammatory cells and production of collagen-like~          proteins (termed 'lectins')~        4. The inflammatory response is most pronounced in the primary afflicted compartment.~   "
87944|NCT01906216|"~     This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy~     and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced~     hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the~     prognostic factors that influence the survival.~      Data on the efficacy and safety of sorafenib in combination with TACE in patients with~     advanced HCC are lacking. Because in western countries, advanced HCC is considered as a~     contraindication for TACE treatment. However, clinical practice patterns differ markedly~     between Asia and western countries: in Asia TACE is performed in selected advanced HCC~     patients. We consider sorafenib combined with TACE could achieve better survival benefit~     than sorafenib alone in selected advanced HCC patients.~   "
87945|NCT01906203|"~     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU~     assessing the evolution of body composition using bioelectrical impedance analysis.~   "
87946|NCT01906190|"~     This clinical study will be performed in subjects aged 12-60 years old enrolled in~     NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the~     immune response of influenza vaccine up to 24 months after vaccination.~   "
87947|NCT01906177|"~     The primary objectives of this pilot clinical study include:~        -  Evaluate clinical outcomes and quality of life on patients who received Vanguard PS~          Total Knee in Korean population~        -  Evaluate safety of Vanguard PS Total Knee in Korean population~   "
87948|NCT01906164|"~     This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally~     administered ALS-008176 in healthy volunteers.~   "
87949|NCT01906151|"~     The purpose of the study is to determine the relationship of the intraocular pressure~     patterns recorded during 2 sessions using Triggerfish, before and after elective laser~     peripheral iridotomy in angle closure glaucoma patients~   "
87950|NCT01906138|"~     The purpose of the study is to determine the relationship of the intraocular pressure~     patterns recorded during 2 sessions using Triggerfish, before and after elective laser~     peripheral iridotomy in angle closure glaucoma patients.~   "
87951|NCT01906125|"~     This study is intended to establish the equivalence of 2 formulations to the intended final~     market product. The formulations to compare are the capsule given to patients in the phase I~     and II studies and the capsule that is being administered to the patients in the phase III~     trials. Both capsules will be compared to the intended final market capsule. The comparison~     will be performed looking at the pharmacokinetic parameters that define the rate and extent~     of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing~     these parameters calculated after a single 125 mg dose of the 3 capsules identifying like~     that if there are significant differences between these 3 formulations.~   "
87952|NCT01906112|"~     The purpose of this study is to determine benefits of surgery for the primary in patients~     with breast cancer stage IV in randomized controlled study.~   "
87953|NCT01906099|"~     This randomized cross-over study was designed to investigate the effects of legume enriched~     diet consumption on cardiovascular risk factors among first degree relatives of diabetic~     patients.~   "
87954|NCT01906086|"~     The aim of this randomized cross-over study was to determine the effects of legume~     consumption on adiponectin and inflammatory factors among first degree relatives of diabetic~     patients~   "
87955|NCT01906073|"~     Today, patients with cancer pain in need of opioids for moderate to severe pain get~     long-acting morphine twice a day and morphine tablets taken on demand in addition. This~     procedure might be based on the assumption that cancer pain is persistent, although the~     evidence to support whether this assumption applies to all cancer patients is lacking. Some~     cancer patients might not need a fixed dose of long-acting morphine.~      Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an~     opioid on demand when pain occurs.~      A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl~     nasal spray taken on demand, showed that this treatment was apparently feasible and safe for~     these patients.~      This approach is studied further in NFCP-II. The participants will be treated with~     rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary~     outcome will be patient satisfaction.~      The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a~     treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken~     twice a day. After 10 days of treatment there is a crossover and the opposite drug is used~     for the same participant. Morphine tablets can be taken on demand in all phases of the~     study.~      The participants will meet the investigator at inclusion, at the crossover and at the end of~     treatment. During the study, a diary is filled in by the participants every morning.~     Questions about pain and side effects are answered. Satisfaction is measured at the~     crossover and at end of treatment while preference is measured at the end of treatment.~   "
87956|NCT01906060|"~     The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical,~     Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a~     tracheal tube. This intubating laryngeal airway device (ILA) is already commercially~     available and worldwide certificated (CE 0482), but data about the success rates of blind~     intubation via this device in adult patients are lacking. Success rates of blind intubations~     with the non-self-inflating device range between 57 and 97%.~      Although the self-inflating disposable Air-Q device is certified for blind intubation, the~     success rate and rate of adverse events associated with this procedure have not been~     published so far. In a study comparing adverse events of conventional intubation with blind~     intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and~     cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot~     study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported~     dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One~     study using the self-pressurised disposable Air-Q for ventilation of children showed~     broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat~     were reported in 1%.~      This data suggests that the rate of adverse events using the Air-Q supra-glottic device are~     comparable to other devices such as LMA.~        -  Trial with medical device~   "
87957|NCT01906047|"~     We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis~     bronchiectasis outcome.~   "
87958|NCT01906034|"~     Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in~     impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk~     factors are age-related decreases in balance and strength / power performance as well as~     cognitive decline. Additional studies are needed to develop specifically tailored exercise~     programs for older adults that can easily be implemented into clinical practice. Thus, the~     objective of the present trial is to assess the effects of a fall prevention program that~     was developed by an interdisciplinary expert panel on measures of balance, strength / power,~     body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy~     older adults. Additionally, the time-related effects of detraining are tested.~      Methods/Design Healthy old people (N = 66) between the age of 65 to 80 years will~     participate in this trial. The testing protocol comprises tests for the assessment of static~     / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis),~     proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance~     (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand~     grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test). Further,~     body composition will be analysed using a bioelectrical impedance analysis system. In~     addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation~     Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall~     risk determinants (i.e., Fall Efficacy Scale - International) will be included in the study~     protocol. Participants will be randomized into two intervention groups or the control /~     waiting group. After baseline measures, participants in the intervention groups will conduct~     a 12-week balance and strength / power exercise intervention 3 times per week, with each~     training session lasting 30 min (without warm-up and cool-down). One intervention group will~     complete a supervised training program (2x supervised training per week / 1x home training~     per week), while the other intervention group will complete a training after the same~     protocol that is home-based (3x home training per week) and controlled by phone calls every~     two weeks. Post-tests will be conducted right after the intervention period. Additionally,~     detraining effects will be measured 12 weeks after program cessation. The control group /~     waiting group will not participate in any specific intervention during the experimental~     period, but will receive the extensive supervised program after the experimental period.~      Discussion It is expected that particularly the supervised combination of balance and~     strength / power training will improve performance in variables of balance, strength /~     power, body composition, cognitive function, psychosocial well-being, and falls~     self-efficacy of older adults. In addition, information regarding fall risk assessment,~     detraining effects, and supervision of training will be provided. Further, training-induced~     health-relevant changes, such as improved performance in activities of daily living,~     cognitive function, and quality of life, as well as a reduced risk for falls may help to~     lower costs in the health care system. Finally, practitioners, therapists, and instructors~     will be provided with a scientifically evaluated, feasible, safe, and easy-to-administer~     exercise program for fall prevention.~   "
87959|NCT01906021|"~     Background:~      - Ablation is a procedure that heats tumor tissue to a high temperature to destroy it.~     Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the~     site. Currently, doctors tell what area is heated by using the probe s manufacturer~     estimates. These estimates are imprecise. Doctors insert small needles to measure the~     temperature around the area being heated. Doctors also perform scans of the area, but these~     cannot show which tissue has been heated and which has not. Right now, only contrast scans~     can show that. But researchers have developed software that uses images from routine scans~     to create a temperature map. They want to test the software to see if doctors can monitor~     the procedure without using more needles and without contrast scans.~      Objectives:~      - To test software that might help doctors perform ablations better in the future.~      Eligibility:~      - People over 18 years of age already scheduled to have an ablation.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants will visit the clinic for their already-scheduled ablation. The doctor~          will use the study software to~      analyze the temperature in the area being heated. The software will not come into contact~     with a participant s body.~      - Participants will undergo scans that are necessary for the procedure, but one or two~     additional scans may be done as part of this study.~   "
87960|NCT01906008|"~     The goal of this clinical research study is to learn if minocycline can reduce numbness,~     pain, and/or loss of motor function in patients with colorectal cancer. In this study,~     minocycline will be compared to a placebo.~      The study doctor can explain how the study drug is designed to work.~      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
87961|NCT01905995|"~     Electrid activity of the basal ganglia will be recorded with an implantable deep brain~     stimulation device (supplied by Medtronic Inc).~      Study hypothesis is that these activities differ according to what the patient does, i.e.~     are different during gait and speech.~   "
87962|NCT01905982|"~     The purpose of this study is to determine whether different types of breathing therapies in~     patients with COPD III-IV decrease dyspnea, increase activity and have impact on~     parasympathetic activities.~   "
87963|NCT01905969|"~     Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has~     improved disease free time and survival. However, there are still considerable number of~     patients experience relapse even after adjuvant chemotherapy. In an attempt to select~     patients who really benefit the postoperative adjuvant chemotherapy, we have identified~     potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by~     immunohistochemical validation. In the present study, we further validate the significance~     of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response~     can be determined immediately after surgery.~   "
87964|NCT01905956|"~     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several~     studies demonstrating their efficacy, we are conducting this study to look into the efficacy~     and safety of this novel combination of three fibres, in appetite regulation.~   "
88280|NCT01901770|"~     This clinical trial studies an educational intervention for parents and providers in~     increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia.~     Educational interventions may be effective in increasing the number of participants whose~     daughters receive HPV vaccination.~   "
87966|NCT01905930|"~     On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM~     Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a~     degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy~     for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck~     pain, or myelopathy due to a single-level abnormality localized to the disc space, and~     manifested by at least one of the following conditions confirmed by radiographic imaging~     (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of~     osteophytes), and/or visible loss of disc height as compared to adjacent levels.~      The purpose of this post-approval study is to evaluate the long-term (7 year) safety and~     effectiveness of the PCM Cervical Disc.~   "
87967|NCT01905917|"~     The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation~     intervention involving video-conferencing with a therapist and use of wearable monitoring~     devices in the first three months after stroke results greater functional recovery using the~     Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke~     at three months survivors compared to usual care.~      The secondary hypotheses tested in this randomized control trial are that a~     tele-rehabilitation intervention involving video-conferencing with a therapist and use of~     wearable monitoring devices in the first three months after stroke results in:~        -  Functional recovery using the LLFDI at 6 months,~        -  Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel~          Index at 3 and 6 months,~        -  Greater contact time with a therapist at 3 & 6 months,~        -  Better balance at 3 & 6 months,~        -  Better self-report health-related quality of life at 3 & 6 months,~        -  Decreased health service utilization at 3 & 6 months,~        -  Reduced caregiver burden at three months survivors compared to usual care at 3 & 6~          months.~   "
87968|NCT01905904|"~     The purpose of the study was to investigate the effects of different doses of sevoflurane~     used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and~     recovery profiles~   "
87969|NCT01905891|"~     The purpose of this study is to correlate pathological features from specimens in order to~     determine if this new molecular diagnostic technique can be used to detect risk of skin~     cancer.~   "
87970|NCT01905878|"~     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.~     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major~     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight~     Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As~     a drug that consists of serin protease enzyme, suspected that the mechanism of action of~     lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded~     that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic~     effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic~     of this drug. As a pilot study, the aim of this study is to evaluate biological half life of~     DLBS1033.~   "
87971|NCT01905865|"~     Background:~      - Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They~     may not know how to take care of their child or how the illness will affect their family~     life. Researchers want to study how these parents cope with and adapt to their child s~     condition in light of this uncertainty. Being uncertain can make it hard for parents to~     adapt. But it also might give them hope. Researchers want to study how uncertain the parents~     think their situation is and how that affects the way they think they can cope. Personality~     traits, like being able to handle uncertainty and being resilient, might also affect coping.~      Objectives:~      - To understand how having a child with an undiagnosed illness affects the way their parents~     think they can cope.~      Eligibility:~      - Adults with a child who has a medical condition that has not been diagnosed for at least 2~     years and involves at least 2 parts of the body.~      Design:~        -  Participants will answer survey questions for about 30 minutes. The questions are about~          their thoughts and feelings about having a child with an undisclosed illness.~        -  Participants can take the survey on paper or online.~   "
87972|NCT01905852|"~     Background:~      - Aortic valve stenosis is a disease that makes a major heart valve get smaller. This~     reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a~     couple of ways, including replacing a heart valve.~      Objectives:~      Researchers want to study fibrosis in the heart. A sub-study will test whether heart~     function and blood supply improve after a valve replacement.~      Eligibility:~      - Adults at least 18 years old with aortic stenosis.~      Design:~        -  Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of~          their heart. This uses magnets, radio waves, and computers to produce detailed pictures~          of the heart.~        -  After this visit, participants will have their aortic valve procedure at the the~          Washington Hospital Center. A hospital team will contact participants for 1 year by~          phone or email. This follow-up will consist of 15 minutes of questions about the~          participant s health status.~        -  Some participants will join a sub-study.~        -  They will be given an additional medication to evaluate the blood supply of the heart.~        -  They will visit a clinic for 1 day for an MRI of their heart, as part of the main~          study, prior to the aortic valve replacement.~        -  After they have their valve replaced at the hospital, they will return to the clinic~          for another MRI.~        -  They will have the same follow-up as in the main study.~   "
87982|NCT01905722|"~     The overarching goal of this program project grant is the development of technologies that~     lead to new methods for studying, detecting, and treating type 2 diabetes, and their~     integration with hypothesis-driven diabetes research projects.~      Project 4 of the grant, led by Dr. Craig Malloy at UTSW, will develop and apply new~     technology in MRI to test core hypotheses about the development of insulin resistance in~     people. The long-term goal is to develop technology to monitor metabolism in skeletal~     muscle, brain and the liver using magnetic resonance imaging (MRI) and magnetic resonance~     spectroscopy (MRS) in a 3 Tesla and 7 Tesla MRI scanners. These advanced imaging methods~     allow researchers to take pictures of the inside of the body and to measure metabolism as it~     occurs in the MRI scanner. Standard clinical MRI for medical diagnosis and treatment is~     performed in a 1 Tesla or 3 Tesla MRI scanner.~      A primary goal of the 7 Tesla research program is to develop a group of protocols for~     investigating specific metabolic pathways in adipose (fat) tissue, skeletal muscle and the~     liver. This study is being done to improve methods of imaging and measuring molecules in a 3~     Tesla or 7 Tesla scanners.~   "
87973|NCT01905839|"~     Background:~      - Parkinson s disease (PD) affects half a million Americans, causing slow movements,~     tremors, stiffness, and trouble walking. Currently, these symptoms are measured by physical~     exam, but this is unreliable and requires an office visit. Researchers want to study a~     different way to measure PD symptoms, using a home-testing machine called a QMAT device. It~     can test how quickly someone moves doing different tasks. Researchers will study how this~     testing compares to physical exam testing and whether the device can detect changes in PD~     symptoms over time.~      Objectives:~      - To see if a home testing device can be used to evaluate Parkinson s disease symptoms.~      Eligibility:~      - Adults at least 18 years old with PD.~      Design:~        -  Participants will have about 22 clinic visits over 5 years. Each visit will take up to~          3 hours. Visits will be scheduled along with visits for another study.~        -  At visit 1, participants will learn to use the QMAT device and how to send testing~          information to the clinic by computer. The device has a computer screen, some buttons,~          and some pegs. Participants will get a device to take home and any accessories.~        -  Participants will learn 2 QMAT tests. For one, they will press keys as fast as~          possible. For the other, they will move pegs into holes. The tests will take a total of~          about 20 minutes.~        -  Participants will take both tests at home, 2 times on the same day each week, once~          before their medication, once after.~        -  A study coordinator will monitor the participant s computer data and discuss the~          at-home testing at the clinic visits.~   "
87974|NCT01905826|"~     Background:~      - GATA2 deficiency is a genetic disorder that can cause problems with a person s immune~     system and other body systems. Some people who have this disorder develop few problems from~     it. Others can have a wide range of health problems, from skin problems, to hearing loss, to~     cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to~     better understand what types of health problems it can cause, and why it causes problems in~     some people but not others, and at different ages.~      Objectives:~      - To improve understanding of GATA2 deficiency so there can be better diagnostic tests and~     treatments in the future.~      Eligibility:~      - People 2 years of age or older who have a GATA2 gene mutation or certain health conditions~     that are commonly seen in people with this mutation and their blood relatives.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected to see whether participants have the GATA2 genetic mutation.~          Several other tests may be recommended, but participants can decline to take them.~        -  Participants will be eligible to receive standard care for GATA2 deficiency through~          this protocol. They may be eligible for other clinical trials at the National~          Institutes of Health as well.~        -  Participants will have regular study visits once a year to evaluate their GATA2~          deficiency. Participants will take part in the study for at least 3 years and up to 15~          years. At these follow-up visits, participants will fill out a questionnaire and take a~          physical exam and blood tests. Other tests may be performed as needed.~   "
87975|NCT01905813|"~     The study will be conducted in three parts. Part 1 is a dose escalation phase to determine~     the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated,~     pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and~     itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a~     tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3~     will further evaluate the chosen doses of INCB040093 alone and in combination with~     itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.~   "
87976|NCT01905800|"~     Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine~     vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth~     and seventh decades of life. The disease can be a major handicap for the affected patient,~     and causes a great expense for society. The traditional manual treatment with repositioning~     maneuvers has greatly improved the possibilities for treatment of BPPV the last decade.~     However some patients are still difficult to diagnose and treat, and there are some who for~     health reasons cannot undergo traditional manual treatment. In this perspective there is a~     demand for a reliable, effective and precise method to treat all semicircular canals for the~     differentiated patient groups, and the techniques are under continuous development.~   "
87977|NCT01905787|"~     The purpose of this study is to take advance of the presence of two different cohorts of SCA~     patients in one country, the first group included SCA patients from Bedouin Arab origin that~     lives in Israel for more than one century and originally comes from African countries or~     Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology~     Unit of the Emek Medical Center, the second group are SCA patients from African origin that~     come to Israel in the last decades and belong to original African population, this group~     receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov~     Medical Center. A third group is a cohort of SCA patients treated at Schneider Children's~     Hospital Hematology Unit. Those patients belong also to the Israel Arab population and~     patients from a village that African Muslims live for many years. The characteristics of the~     three groups will be compared to the characteristics of a fourth group, a cohort of~     Afro-American SCA patients that are followed up and treated at the Pediatric Hematology~     Unit, Detroit Children's Medical Center, Detroit, Michigan, USA.~   "
87978|NCT01905774|"~     Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal~     iron absorption. Renal function caused by Iron overload was studied in a previous study and~     shows principally tubular disfunction. In this previous study the Iron chelator used was~     Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by~     the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to~     assess the renal function in Thalassemia Major patients treated with this new oral iron~     chelator and compare the results with our previous study.~   "
87979|NCT01905761|"~     To systematically follow patients seen at the University of Minnesota's Lifestyle Medicine~     Program for Weight Management.~   "
87980|NCT01905748|"~     Acute Migraine attacks can be related to vascular or coagulation activation. Previous~     studies found relative high incidence of prothrombotic events in Migraine. The present study~     intends to assess the coagulation system and activation in patients with Migraine during~     steady state phase and at the beginning of attacks and after 72 hours. A control group of~     patients with another acute neurologic event like convulsions will be also studied. Patients~     will be at pediatric age and teenagers.~   "
87983|NCT01905709|"~     The objective of this study is to provide treatment with Fecal Microbiota Transplantation~     (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has~     been shown that good bacteria (like that found in the stool from a healthy donor) attack~     Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile~     - and they attach to the surface of the colon lining, which prevents the Clostridium~     difficile toxin (poison) from attaching.~      FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of~     the patient with CDI during a colonoscopy.~      The method used to deliver the FMT will depend on individual characteristics of the subject~     and is at the discretion of the treating physician. FMT may be administered by the following~     methods.~        -  Colonoscopy: This method allows full endoscopic examination of the colon and exclusion~          of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have~          an impact on subject's treatment or response to therapy.~        -  Sigmoidoscopy: This method still allows infusion of the stool into a more proximal~          segment of the colon than an enema, but may not require sedation. This method may be~          beneficial in subjects who are elderly or multiparous and who may have difficulty~          retaining the material when given as enema. Sigmoidoscopic administration eliminates~          the additional risks associated with colonoscopy in subjects who may not have a clear~          indication for colonoscopy.~        -  Retention enema: This method may be preferable in younger subjects who have already had~          recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in~          subjects with significant co morbidities and may not tolerate endoscopy.~      The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL,~     through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of~     colonoscopic delivery, the material will be delivered to the most proximal point of~     insertion.~      The subject is encouraged to retain stool for as long as possible.~   "
87984|NCT01905696|"~     Nitric oxide is believed to contribute to regulation of blood flow by its selective binding~     to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a~     PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect~     of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using~     oral N-acetylcysteine.~   "
87985|NCT01905683|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents~     (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness~     (spasticity) due to cerebral palsy.~   "
87986|NCT01905670|"~     The study is intended to demonstrate the safe implant of small receiver-electrodes into the~     endocardial surface of the left ventricle and to demonstrate its utility in providing~     cardiac resynchronization therapy in heart failure patients.~   "
87987|NCT01905657|"~     This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants~     with non-small cell lung cancer (NSCLC) who had experienced disease progression after~     platinum-containing systemic therapy. Participants were assigned randomly to receive either~     pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel~     75 mg/m^2 Q3W. This study used an adaptive trial design so that the total number of~     participants randomized depended upon demonstration of sufficient objective responses at an~     interim analysis.~      Based on the positive outcome of the Overall Survival (OS) analysis, Protocol Amendment 12~     (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel~     and experienced disease progression, to be permitted to crossover to receive pembrolizumab 2~     mg/kg Q3W as long as Inclusion/Exclusion criteria were met. These participants were~     participating in the Cross-Over Phase.~      The primary study hypotheses are that pembolizumab prolongs OS and Progression-free Survival~     (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by~     independent radiologists' review in previously-treated participants with NSCLC in the~     strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and~     in participants whose tumors express PD-L1 compared to docetaxel.~   "
87988|NCT01905644|"~     The main objective of this study is to compare post partum rates of anal sphincter rupture~     (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears~     between two groups: (1) women who are screened just after delivery by performing a perineal~     ultrasound versus a similar group of women who did not receive screening. This study was not~     designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal~     surgical procedures in each arm.~   "
87989|NCT01905618|"~     This study compares two methods of teaching the 5As (Ask, Advise, Assess, Assist, Arrange)~     for tobacco dependence treatment to medical students: 1) traditional medical education (TE),~     and 2) multi-modal education (MME). The MME arm builds upon the traditional curriculum at~     the medical school by providing a web-based instructional program, a role play, preceptor~     training, and a booster session. The hypotheses are that MME will outperform TE on observed~     5As counseling skills on the Objective Structured Clinical Exam (OSCE); and MME will~     outperform TE on self-reported 5As counseling skills.~   "
87990|NCT01905605|"~     Sensory gating is defined as the automatic process of inhibiting brain response to repeated~     auditory sounds. Infants who brains respond similarly to two identical sounds presented~     about 1/2 second apart are more likely to have later problems with attention than infants~     who suppress response to the second sound. This study will examine whether providing a~     nutritional supplement, phosphatidylcholine, for two months in infancy will result in an~     increased likelihood of developing more robust sensory gating.~   "
87991|NCT01905592|"~     The purpose of this study is to compare progression-free survival (PFS)in patients with~     advanced/metastatic breast cancer who have a BRCA gene change when treated with niraparib as~     compared to those treated with physician's choice~   "
87992|NCT01905579|"~     The purpose of this study is to compare flaremetry readings with the protein content of the~     aqueous humor and the clinical grading of flare.~   "
87993|NCT01905566|"~     Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic~     plaque inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta.~      Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities.~     Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque~     inflammation, and ticagrelor may be superior in efficacy to clopidogrel.~   "
87994|NCT01905553|"~     To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to~     administration under fasted conditions.~   "
87995|NCT01905540|"~     This study will evaluate the relative bioavailability of the new SSP-004184SS capsule~     formulation compared to the original SSP-004184AQ drug plus excipients formulation.~   "
87996|NCT01905527|"~     This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services~     (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine~     the optimal services to enhance medication adherence and treatment persistence with Rebif ®~     subcutaneous three times a week.~   "
88281|NCT01901757|"~     To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in~     fed versus fasted condition~   "
87998|NCT01905501|"~     This study aimed to evaluate the possible protective effect of anesthetic technique~     balanced(with sevoflurane) compared with total intravenous anesthetic technique~     (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect~     in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap~     during transfer to receiving area. The investigators will evaluate the continuous flap~     tissue oximetry and the level of biochemical markers.~   "
87999|NCT01905488|"~     Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve~     system to prevent retrograde blood flow to the brain. Anatomical studies revealed that~     bicuspid or tricuspid valves were located in both jugular veins 2 cm above the~     subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence~     (IJVVI) may result in retrograde flow which leads to brain congestion and increase of~     intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been~     reported to be associated with transient global amnesia (TGA), cough syncope, exertional~     headache, transient ischemic attack, and air embolism. Demographic data are associated with~     the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male~     gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI~     including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension.~     Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery~     because of its significant benefits such as smaller incision, less severe postoperative~     pain, less intraoperative bleeding, and shorter hospital stay compared to traditional~     radical prostatectomy. The patients undergoing RLP are mostly over 60 years old, have~     neurologic, cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg~     position most of the time during surgery, which could cause increases in intra-abdominal and~     intrathoracic pressure.~   "
88000|NCT01905475|"~     The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a~     stem cell mobilizing agent, on cardiac function and infarct size and on safety and~     tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).~   "
88001|NCT01905462|"~     This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of~     gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with~     last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and~     90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with~     LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the~     Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the~     UK, will be analysed in this study.~   "
88002|NCT01905449|"~     Children with speech sound disorders will receive speech therapy using real-time images of~     the tongue from ultrasound. These images will be used to cue the child to change the tongue~     position when producing speech sounds.~   "
88003|NCT01905436|"~     Approximately 5,200 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis and onchocerciasis endemic~     areas. Subject selection will not be based on health status.~      Two sites will be studied, and each study will last for 4 years. Participants will be~     studied only once in cross-sectional surveys. Some subjects may be included in more than one~     annual population survey, but this is not a longitudinal study.~      Investigators will compare annual and semiannual mass drug administration (MDA) for~     lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these~     MDA schedules on soil transmitted helminth infections. MDA will be administered by others~     (Liberian Ministry of Health or Liberian Institute of Biomedical Research).~      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is~     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for~     control of soil transmitted helminth (STH) infections.~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.~        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of onchocerciasis in these populations.~        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
88004|NCT01905423|"~     Approximately 3,500 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis endemic areas. The study will~     be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4~     years. Participants will be studied only once in cross-sectional surveys. Some subjects may~     be included in more than one annual population survey, but this is not a longitudinal study.~     Purpose of the study is to evaluate different mass drug administration (MDA) regimens for~     lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth~     infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of~     this study may enhance efforts to control and eliminate these important neglected tropical~     diseases.~      The investigators will test the hypothesis that accelerated mass drug administration will be~     superior to annual MDA for elimination of lymphatic filariasis and for control of soil~     transmitted helminth infections (STH):~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF).~        2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
88005|NCT01905410|"~     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity~     inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop~     single-target selective drugs to treat pain, but usually unsuccessful due to the lack of~     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is~     expected to have a dual-target activity, demonstrated having a synergism between GlyT2 and~     5HT2A antagonistic activities to maximize an antinociceptive effect in the in vivo animal~     models. Now the investigators are developing VVZ-149 as an IV injection to treat~     post-operative pain.~      The primary objective of this study is to evaluate a safety, tolerability and~     pharmacokinetic properties of VVZ-149 injection with placebo in healthy male volunteers.~     This Phase 1 study consists of a randomized, double-blind, placebo controlled, single and~     multiple ascending dose (SAD & MAD) escalation clinical trials.~   "
88008|NCT01905371|"~     This is an NIH Pilot Clinical Trial Grant designed to provide data to permit the rationale~     design of a subsequent efficacy study. The purpose of this project is to determine the~     potential benefit of amphetamine combined with physical therapy in enhancing motor recovery~     in patients admitted for inpatient rehabilitation between 10 and 30 days after hemispheric~     ischemic stroke. The study hypotheses are: 1, The addition of treatment with d-amphetamine~     will result in at least a 12.6 point improvement in the Fugl-Meyer motor score 3 months~     after stroke. 2, There will be no clinically significant increase in the frequency of~     serious adverse events associated with treatment with d-amphetamine which would preclude~     further testing.~   "
88009|NCT01905358|"~     The purpose of this prospective data collection is to track patients who are treated at HSS~     who are confirmed with knee osteoarthritis. The registry will collect prospective patient~     related and functional outcomes (including use of assistive devices), medication use and~     imaging data on patients with confirmed osteoarthritis, and the effect of different medical~     interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises,~     supplements, and diet. Information from the data collection will be used to compare outcomes~     of non-surgical alternatives with the end point being knee arthroplasty. The information~     results will enhance our knowledge of the long-term efficacy and effectiveness of~     non-surgical interventions intended to treat the progression of osteoarthritis.~      Hypotheses:~        -  Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa,~          bracing, physical therapy, and a prescribed combination of exercise, diet, and~          supplements will demonstrate statistically significant differences in patient pain and~          functional outcomes compared to usual interventions including use of NSAIDs,~          corticosteroid injections, and use of assistive devices such as canes.~        -  Non-operative interventions for knee osteoarthritis will be associated with different~          rates of breakdown of articular cartilage and different rates of progression of~          osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?~        -  Education about available non-operative treatment methods may change time the end point~          of total or partial knee replacement for patients with knee osteoarthritis of varying~          severity.~        -  Different non-operative interventions will be associated with different times to total~          or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.~        -  An electronic data capture system (EDC) for osteoarthritis patients will improve~          patient care and patient outcomes.~   "
88010|NCT01905345|"~     Randomised training intervention.~      Influence of consecutive training regime on the impact of the myonuclear domain and~     satellite cell~      Sarcopenia~      Despite that the muscle mass can be positively influenced by training, the loading with high~     weights and/or to the total exhaustion is for many old persons not possible.~      Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a~     first phase by endurance training, in order to promote a more effective muscle growth in a~     second phase by resistance exercise.~   "
88011|NCT01905332|"~     This study's aim is to validate a parent-completed brief literacy screening tool (Early~     Literacy Screener) at the 4 year well child check using the Get Ready to Read- Revised~     screening tool as a gold standard. Four year old children who fall below the cutoff score~     for the GRTR-R will be randomized to either receive current standard of care (control group)~     or a referral to receive a 6 month home based literacy promoting program (intervention~     group). After 6 months, both groups will be retested using the GRTR-R. The hypothesis is~     that the change in raw scores on the GRTR-R in the intervention group after 6 months will be~     greater than the change in raw scores in the control group.~   "
88012|NCT01905319|"~     Aims of the study:~        -  to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical~          subtypes in Estonia for the years 1998-2000;~        -  to examine the course and short-term clinical outcome of JIA.~      Method: a prospective population-based study carried on in 14 counties of Estonia~   "
88013|NCT01905306|"~     This clinical study has the objective to compare the radiographic evaluations after 3 years~     of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly~     using the methodology for computer guided implant planning with software polyvalent or free~     hand implants placement.~   "
88014|NCT01905293|"~     The portion size of foods has been identified as an important determinant of energy intake~     in children. It remains to be determined to what extent child weight status and the relative~     reinforcing value of food may interact with the obesogenic food environment to affect energy~     intake. The primary aim of this study was to compare energy intake at a meal in~     normal-weight and obese children when the portion size of palatable, energy-dense foods and~     a sugar-sweetened beverage was systematically increased. We hypothesized that increasing the~     portion size of all foods and the beverage at a meal will lead to a significant increase in~     energy intake in both normal-weight and obese children. Obese children, however, will show a~     significantly greater increase in energy intake than will normal-weight children. A second~     aim of this study was to test if children's response to increases in portion size was~     affected by how reinforcing they find food to be. We hypothesized that, when controlling for~     BMI, children who find food very reinforcing relative to nonfood alternatives will show a~     significantly greater increase in energy intake than will children who find food less~     reinforcing.~   "
88015|NCT01905280|"~     The purpose of this study is to compare the clinical and histologic outcomes for acellular~     dermal matrix and a nonresorbable membrane to determine if either provides a significant~     therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge~     width between the two treatments.~   "
88016|NCT01905267|"~     The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting~     a research study examining how mindfulness can help teenagers stay healthy and prevent~     depression relapse.~   "
88017|NCT01905254|"~     Recent, research has focused on the evaluation of non-invasive methods for the assessment of~     liver fibrosis in patients with chronic liver disease. Among these methods, transient~     elastography is the most promising. The method has been investigated mainly in patients with~     viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for~     detection of liver cirrhosis by transient elastography is highly dependent on the aetiology~     of the underlying liver disease. Only a few studies have evaluated the value of transient~     elastography for patients with autoimmune liver disease and here primarily patients with PBC~     and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively~     investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver~     histology with and without inclusion of the macroscopic appearance using mini-laparoscopy~   "
88018|NCT01905228|"~     The primary objective of the study is to determine the maximally tolerated dose and~     recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with~     metastatic or unresectable advanced solid malignancies.~   "
88019|NCT01905215|"~     The purpose of this first time in human (FTiH) study is to evaluate the safety,~     reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus~     (RSV) investigational vaccines in healthy men.~   "
88021|NCT01905189|"~     Pulmonary arterial hypertension is a disease characterised by pathological changes in the~     pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and~     pulmonary artery pressure. Right ventricular failure is the main cause of death in patients~     with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the~     progressive increase in pulmonary vascular resistance associated with changes to the~     pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a~     patient's functional capacity and survival.~      Right ventricular dyssynchrony was present in a substantial proportion of patients with~     pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular~     function.~   "
88022|NCT01905176|"~     The current trial aims to examine the effectiveness of three different types of nursing~     interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared~     to the usual care. The interventions include promotion of self-care practices through~     education and support; they are either provided before discharge, post-discharge through~     telephone, or both.~   "
88023|NCT01905163|"~     This prospective nonrandomized multicenter phase II study, will evaluate the possibility of~     performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in~     highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.~   "
88024|NCT01905150|"~     Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is~     the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being~     6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with~     limited efficacy. A safer and more effective therapy for this devastating disease is greatly~     needed.~      G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and~     used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin,~     Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic~     cancer) is based on laboratory and clinical results, which indicates the synergistic~     efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug~     resistance that cancer cells frequently develop. Also, because of their low doses, this~     regimen is less toxic than when these drugs are used alone.~      Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily~     nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer~     activities. This is especially true when Vitamin C is used in combination with other~     anti-cancer drugs.~   "
88025|NCT01905137|"~     The purpose of this study is to determine whether there is a change in patient-reported~     pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of~     normal saline.~   "
88026|NCT01905124|"~     This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active,~     sight-threatening, noninfectious intermediate or posterior uveitis.~   "
88027|NCT01905111|"~     The primary objective of this trial is to explore the safety and tolerability of BI 853520~     monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese~     patients with advanced or metastatic solid tumours.~      Secondary objective is collection of preliminary data on anti-tumour efficacy~   "
88028|NCT01905098|"~     The purpose of this study is to determine the impact of sauna use on polychlorinated~     biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety,~     feasibility, and tolerability, and effects on quality of life and wellness. We hope to~     determine if there is a link between lower PCB levels in blood and sauna use.~   "
88029|NCT01905085|"~     Indirect calorimetry is valuable in determining resting energy expenditure in infants,~     children and adults. This measure will estimate the number of calories needed per day under~     resting conditions.~      Adding physical activity measures will help estimate total energy requirements in~     individuals. With the rise in obesity, numerous programs of prevention are being developed.~     Being able to characterize carefully energy intake and energy expenditure is one of the~     challenges of most of these initiatives.~   "
88030|NCT01905072|"~     The goal of this study is to compare the effectiveness of structured CHW- provided home~     visits, using an intervention created through community-based participatory research, to~     standard care received through WIC office visits in preventing the development of overweight~     (weight/length >85th percentile) and obesity (weight/length >95th percentile) in infants~     during their first 2 years of life.~      Hypothesis 1: Children in the intervention group will remain within their growth centiles in~     height/weight and weight for age, while children in the control group will increase in~     height/weight percentiles and weight percentiles more rapidly (> .67 SD) during the first~     year of life.~      Hypothesis 2: Fewer children who receive the intervention will have BMI >95th percentile at~     ages 2 and 3 than the children in the control group.~      Hypothesis 3: Children who receive the intervention will exclusively breastfeed for a longer~     period of time than will children in the control group.~      Hypothesis 4: Children who receive the intervention will have a higher percentage of fruits~     and vegetables and a lower percentage of sweetened beverages, desserts, and candy in their~     diets at ages 1, 2, and 3, than will children in the control group.~      Hypothesis 5: Parents in the intervention group will be more responsive to infant feeding~     cues (hunger, satiety)than parents in the control group.~   "
88031|NCT01905059|"~     Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of~     protease inhibitors with or without lamivudine over a period of 96 weeks. The primary~     outcome will be the failure rate at 96 weeks. This study will include 260 participants,~     former participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso~     and Dakar.~   "
88032|NCT01905046|"~     The purpose of this research study is to test whether metformin, a drug commonly used to~     treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a~     marker of breast cancer risk) in women at increased risk for breast cancer. There will be~     testing for the presence of atypia in the breast after metformin is given to see if it can~     get rid of atypia. The study will compare the effects, good and/or bad, of metformin or~     placebo on atypia to find out which is better.~      Note: The standard drug used for the breast cancer prevention is tamoxifen. If the patient~     is eligible to take tamoxifen, he/she must be offered tamoxifen prevention as part of~     clinical care. Metformin and tamoxifen are not similar and function differently. This study~     is not investigating the use of tamoxifen. Metformin is not approved for preventing breast~     cancer, but is currently being tested to determine if it can prevent breast cancer.~   "
88033|NCT01905033|"~     Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools~     available to the clinician to initiate therapy of patients with sepsis mainly comprise of~     symptom classification systems and culture techniques, which provide aspecific and slow~     information.~      Objective: The ultimate goal of this program is to assist the physician at the bedside in~     tailoring the treatment of an individual patient suffering from sepsis by generating rapid~     molecular information about the causative pathogen and the host response.~      Deliverables: Rapid tests (sample-in-result-out) that can be used by health care personnel~     at or close to the bedside and that provide rapid information (within two hours) about the~     presence or absence of sepsis, the causative pathogen and the risk of the individual patient~     for sepsis complications and death.~      Design: The program is organized into four Work Packages (WPs) along a clinical, discovery~     and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted~     to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these~     patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from~     these patients will be used to develop rapid, fully automated DNA-based bedside tests that~     identify microorganisms and also provide information about their resistance to antibiotics.~     In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and~     to develop rapid and easy to perform tests that provide information about the risk profile~     of the patient. In addition, plasma levels of selected protein biomarkers will be measured~     for comparison of their value with that of the identified leukocyte molecular signatures.~     WP4 is responsible for the ICT management of the project. The Clinical Platform (covered by~     WP1 and WP4) delivers patient data and biological samples to the discovery and technology~     platforms. The Discovery Platform (covered by WP2 and WP3) uses patient data and biological~     samples to develop tests for detection of the infectious agent causing sepsis and for~     stratification of patients according to their risk for sepsis complications, including~     death. The results generated within the discovery platform will be delivered to the~     technology platform. The Technology Platform (part of WP2 and WP3) has the specific aim to~     develop rapid assays that run on a fully automated (micro)fluidics platform that is so easy~     to operate that it can be used in decentralized settings such as (close to) the ICU. The~     developed assays will make use of the knowledge generated in the discovery platform.~   "
88034|NCT01905020|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose~     levels in a out-patient study in adults and adolescents with type 1 diabetes.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared~     to single-hormone closed-loop strategy, which in turn is more effective than the~     conventional pump therapy.~   "
88035|NCT01905007|"~     The primary objective of this study is to compare the composite outcome of total mortality~     and operative complications in patients who do not undergo defibrillation testing to those~     who do undergo defibrillation testing at the time of initial ICD implantation.~   "
88036|NCT01904994|"~     Despite increased HIV (Human Immunodeficiency Virus) infection testing in Africa, many~     patients never enroll in subsequent HIV care after testing or remain in care after an~     initial enrollment. This study's aim is to improve linkage to HIV care and retention in HIV~     care through the use of feasible, evidence-based, and practical interventions. The study~     takes place in Swaziland, the country with the highest HIV prevalence (24%) in sub-Saharan~     Africa. The study will randomize groups of HIV testing sites and affiliated clinics to~     either standard of care or a combined intervention strategy (CIS) which consists of point-of~     care CD4 (cluster difference 4)testing at time of HIV testing, fast-track HIV medications~     for those who are eligible for treatment,mobile phone appointment reminders, care bags~     filled with health prevention materials, and financial incentives. The study outcomes are~     linkage to and retention in care as well as cost effectiveness, feasibility of~     interventions, and patient acceptability of interventions.~   "
88037|NCT01904981|"~     Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion.~     However, there have been very few randomized clinical trials to support use of any of these~     treatments. Several animal studies and observational reports suggest that ARBs can be useful~     in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been~     evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate~     the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a~     beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of~     the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated,~     multi-center, randomized controlled open-label trial. Patients with small AAA (aorta~     diameter <5cm) will be randomized 1:1 either to valsartan or to atenolol group.~     Randomization will be stratified by the AAA size (max. diameter >4 cm or ≤4 cm). Patients~     will receive either valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or~     more) for 12 months. A CT scan will measure the maximal diameter of AAA at baseline and 12~     months. The annual growth of AAA will be compared between the valsartan and the atenolol~     group.~   "
88038|NCT01904968|"~     We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate~     (methylation assay) which has enabled us to characterize the level of methylation of 807~     potential markers on a series of 200 adenocarcinomas of the colon (C18) and rectosigmoid~     junction (C19) resected between 1998 and 2001. The results, validated by pyrosequencing,~     allowed us to establish a panel of 12 markers to assess the level of methylation. The aim of~     this project is to validate the prognostic value of this panel in a second cohort of~     patients with adenocarcinomas (stage I to IV) resected between 2002 and 2006 in public and~     private hospitals (n=685).~      This study relies on an original collection of surgical specimens of colorectal cancers~     resected in public and private hospitals among patients resident in the département of~     Côte-d'Or and followed by the cancer registry of Burgundy. Samples obtained from each cancer~     and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane~     Biological Resources Centre(certified S 96900). Annotations are collected by the cancer~     registry staff from multiple sources (pathologists, gastroenterologists, oncologists and~     radiotherapists).~      Pyrosequencing will be used to quantify the level of methylation. The percentage of~     methylated allele for each marker on cancerous DNA and the ratio of methylated markers to~     the number of markers analyzed will be determined. The molecular status of MSI, BRAF, KRAS,~     and PI3K will be taken into consideration.~      To study the prognosis, relative and relapse free-survival will be calculated. A~     multivariate relative survival analysis will be performed to determine independent~     prognostic factors taking into account the characteristics of patients and tumours and~     epigenetic and molecular alterations. Epigenetic alterations will be described according to~     age group, sex and subsite. The epigenetic phenotypes will be evaluated according to already~     known molecular status using logistic regression models.~   "
88039|NCT01904955|"~     The results of this study will make it possible, thanks to better understanding of the~     natural history of colorectal cancer, to define new treatment and surveillance strategies~     for colorectal cancers resected with curative intent, so as to improve management and thus~     improve patient survival.~      These data will also make it possible to calculate the prevalence of patients who require~     treatment or surveillance because of their disease.~   "
88199|NCT01902849|"~     Knowing the fact that the anesthetic substances can alter the immune response during the~     surgery, the purpose of the study is to evaluate the influence of two general anesthetic~     techniques - inhalation vs. total intravenous anesthesia on the immune response in patient~     with colorectal surgery for neoplastic disease, evaluated by the plasma level of the~     interleukins 6 and 10(IL6, IL10).~   "
88040|NCT01904942|"~     The project is based on a case-control study including cirrhotic patients with (200 cases)~     and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in~     proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The~     proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two~     approaches will be used in the proteomic study: A global approach based on the comparison of~     proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The~     particularity of this study with regard to previous studies is : the procedures used to~     purify the sub proteomes (Five automated methods including depletion fractionation and~     purification will be applied), the qualification of the generated data with the introduction~     of quality controls, the high number of samples included in the study. The second approach~     BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the~     capture, quantification and characterization of proteins.~      The quality controls allow to quantify the various variability sources and to validate that~     biological variability is higher than technical variability. All the samples will be treated~     and analyzed with the same protocols, 100 samples will be used to validate the marker and~     statistical models developed after analysis of the first 500 samples. The infra-red~     spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university.~     The first 300 samples after feature selection reference spectra, are classified into~     different classes by means of mathematical classification methods such as multivariate~     statistical processes of pattern recognition, neuronal networks, support vector machines and~     methods of case-based classification or machine learning, genetic algorithms or methods of~     evolutionary programming. The analysis of a second set of samples (300) will validate the~     different mathematical classification methods developed.~      In the global study the investigators will unravel the relationship between proteomic,~     spectroscopic and metabolic/nutritional data. The description of these relationships will~     use canonical analysis and multi-block analysis in a more general extent. The goal of these~     methods is to explore relationships that may exist between several groups of quantitative~     variables observed on the same set of individuals.~   "
88041|NCT01904929|"~     The objective of this project is to clarify and improve the efficiency of the standardized~     walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk~     test at a self-selected speed will be evaluated. Such tests, made at a self-selected~     (comfortable, free) speed particularly assess the endurance capacities. The results of~     the physiological measurements during the tests will be compared with those of TM6min of~     Test of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary~     patients, aged over 55 years old, will be included.~      This study should permit a simplification and a better understanding of the clinical-use of~     walk tests. In the future, two kinds of tests might be proposed with different distances, 1-~     200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2-~     self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic~     capacities of the adaptation of the body in response to effort.~   "
88042|NCT01904916|"~     Our knowledge on the genetic mutations in cancer is rapidly expanding and we are~     increasingly testing drugs in mainly metastatic cancer patient populations with rare~     mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated~     NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5%~     frequency). Selecting molecularly stratified patient populations for studies benefits the~     patient as it increases the odds of obtaining benefit from experimental treatment,~     especially in early clinical trials. Moreover it increases the speed and efficacy of drug~     development as signs of efficacy are picked up in earlier phases. Therefore, broad screening~     of molecular lesions in the tumors of patients that are being considered for participation~     in trials is crucial. This pre-selection increases our ability to perform several trials in~     parallel and thus include more patients in more meaningful trials. With the still dismal~     prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials~     in selected patient populations is a key factor in improving prognosis.~      The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited~     number of cancer related genes within 2-4 weeks. We have extensively piloted this approach~     and are now able to deliver clinically meaningful turn-around-times. This development~     enables us to use this technology to enrich clinical trials using targeted therapies for~     patients with specific mutations.~      We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral~     blood sample from all patients included in the trial; the biopsies to obtain information on~     the tumor related genetic mutations (mutational profile) and the blood samples to assess~     each patient's germline DNA background variation. As patients will be asked to undergo an~     invasive procedure it is important to address the potential safety issues. Review of the~     literature and our own experience show that tumor biopsies can be performed with only minor~     complications and acceptable risks. We will recruit patients with metastatic or locally~     advanced solid tumors from patients that can potentially be included in clinical trials.~   "
88043|NCT01904903|"~     HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of~     cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2~     positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block~     the receptor HER2) were developed, patients with HER2 positive breast cancer had a very~     aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly~     targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine,~     patients are able to live longer and have better control of their cancer.~      Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and~     for this reason these treatments were only studied and approved for patients with normal~     heart function.~      In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast~     cancer and mildly decreased heart function along with concomitant evaluation by a heart~     doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do~     frequent monitoring of the heart function with a test called echocardiogram that will give~     us a detailed picture of the heart. We will also draw blood along with routine blood tests~     to try to understand why some patients develop heart problems and others do not. The study~     will take a maximum of 12 months and patients will be monitored for 6 additional months.~      We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast~     cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on~     appropriate heart medications.~   "
88044|NCT01904890|"~     This is a behavioral research study to evaluate the effectiveness of a type of health~     education, lay health worker (LHWs), on increasing the use of a routine health behavior,~     colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening.~     Using quantitative and qualitative methods and a community-based participatory research~     (CBPR) approach, the project will develop and implement a group randomized controlled trial~     to evaluate LHW effectiveness in promoting CRC screening among Asian Americans age 50 to 75.~     The investigators will conduct focus groups and individual interviews with community~     participants to revise training and survey materials developed in prior projects. The~     investigators will recruit LHWs to be randomly assigned to the intervention arm and to the~     comparison arm. The LHWs will each recruit 15 participants from their social network.~     Intervention LHWs will be taught to teach their participants about CRC screening through 2~     outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt.~     LHWs and participants in the comparison group will receive a bilingual CRC brochure as well~     as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator~     and an optional post- intervention LHW outreach session on CRC screening. Effectiveness of~     the intervention will be measured by pre-intervention and post-intervention surveys of~     community participants' CRC screening behaviors. The investigators will also conduct~     ethnographic observations of LHWs and their participants during the small group sessions and~     post- intervention focus groups to understand how such a health education approach may work.~   "
88045|NCT01904877|"~     1. The number of MSM who are tested for HIV in the 4 study clinics over 12 months will~          increase compared with historical data from the same 4 clinics over the past 12 months~          prior to the intervention.~        2. Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts~          at diagnosis than persons diagnosed with HIV over the past 12 months prior to the~          intervention~   "
88046|NCT01904864|"~     This study is a randomized, controlled, double-blinded single center trial to compare the~     efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency~     anemia in infants and young children.~      Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin~     concentration during a twelve week course of treatment to subjects with iron deficiency~     anemia.~      Primary Aim:~      To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional~     IDA in infants and young children as determined by increase in hemoglobin concentration.~      Secondary Aims:~        1. To compare the adverse effects of treatment for IDA between ferrous sulfate and~          NovaFerrum®~        2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA~          (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous~          sulfate or NovaFerrum®~        3. To compare the adherence to study medication between subjects on ferrous sulfate and~          NovaFerrum®~        4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional~          IDA~   "
88047|NCT01904851|"~     XLPAD is an observational study designed to evaluate the effectiveness and use of stent and~     non-stent based therapies among PAD patients. The study will create a registry that will~     include entry of procedural and clinical follow-up information into an online data~     collection software, REDCAP.Data available since Jan 1 2005 will be included in the~     registry, until 14,000 patients have been included. The primary objectives of this~     observational registry study are to:~        1. Compare stent and non-stent based outcomes defined as a composite of symptom driven~          target vessel revascularization (TVR), unplanned surgical revascularization of the~          target limb and need for target limb amputation through 12 months post-index procedure~          (Primary efficacy endpoint)~        2. Compare stent and non-stent based outcomes defined as a composite of causes such as:~          death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel~          revascularization (TVR) and unplanned surgical revascularization/amputation of the~          target limb through 12 months (Primary safety endpoint)~        3. Compare stent and non-stent based change in walking distance, Rutherford category~          and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical~          improvement endpoint)~      Approximately 14,000patients will be enrolled at approximately 60 sites worldwide.~     Enrollment in the observational study will be monitored in an effort to achieve at least 20%~     (and no more than 80%) of the population receiving stents as the initial treatment strategy.~     Follow-up visits by sites will be reported at 6 and 12 months after index procedure to~     collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures~     are not mandated by the registry protocol. Each site will be encouraged to enter follow-up~     information derived from clinically indicated follow-up visits. All events post-index~     procedure till the 7th month will be reported under the 6 month follow-up form and~     subsequent follow-up till the 13th month post-procedure will be entered on the 12 month~     follow-up form.~      Patient management and treatment decisions are at the discretion of the care team per~     routine clinical practice. The procedural aspects (including selection of stent type or~     non-stent based treatments) and follow-up are not mandated by the registry and will be up to~     the discretion of the operator and/or based upon the practice dictated by the clinical care~     of the patient. Therefore the study poses minimal risk to the patient.~   "
88048|NCT01904838|"~     The overall objective of this study is to develop and test an efficient set of self-report~     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual~     factors important in healing. The initial phase of the study involves developing and~     refining an item bank. During the initial 'item bank development' phase, the investigators~     will run focus groups and cognitive interviews with individuals who participate in CAM and~     conventional medicine interventions. The next step of instrument development is called~     Calibration, and involves administering the revised item bank to an internet sample and to~     persons who receive services in a CAM clinic and a conventional primary care setting. The~     items will be calibrated using item response theory and classical test theory. This will~     result in a computerized adaptive testing version of the instrument, as well as a static~     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to~     the Calibration Phase of the study. The final phase of the project will involve conducting~     initial validation studies of the set of instruments. The set of instruments will be called~     the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the~     convergent, discriminant, and predictive validity of the HEAL instruments in a sample of 200~     persons with chronic low back pain who are receiving physical therapy, chiropractic care, or~     mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display~     moderate to large correlations with measures of similar constructs. The HEAL is expected to~     correlate modestly with self-report measures of general psychosocial functioning, in support~     of discriminant validity. Finally, HEAL scores should account for a significant proportion~     of the variance in treatment outcome, supporting predictive validity.~   "
88049|NCT01904825|"~     The aim is to set up tools that will serve as quality tracers for cryopreservation~     procedures.~      To meet this objective, we have chosen to develop reference samples (sentinel cells) that,~     in the medium term, can be used as controls to guarantee the quality of preservation for~     biological samples.~      The biological tools and an optimised follow-up strategy will make it possible to validate~     preservation procedures at the CRB in order to guarantee the perfect stability of samples~     and the validity of clinical studies.~   "
88050|NCT01904812|"~     Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and~     in clinical research requires several aspects to be taken into account, in particular the~     impact of disease activity on quality of life. To date, the effect of systemic lupus on~     quality of life has only been described using generic questionnaires. Among the specific~     questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows~     interesting psychometric properties. The determinants of quality of life specifically~     related to the disease are still unknown and could be studied using a longitudinal cohort~     thanks to the French version of the LupusQol.~   "
88051|NCT01904799|"~     After a CVA, all of the cognitive functions can be affected and analysed, but the presence~     of a language disorder may considerably hamper the evaluation of other functions.~      The battery of rapid tests to screen for and quantify cognitive disorders, including the~     MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because~     they contain items with a strictly verbal response. Because of this, inexperienced doctors~     cannot evaluate higher functions (other than language) of aphasics in routine practice. For~     the same reason, aphasics are regularly excluded from post-cva therapeutic protocols,~     whether or not the trial bears on the evolution of cognitive functions.~      Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions~     without resorting to language.~      The investigator have developed , from validated tests and classical clinical manoeuvers,~     the Cognitive Assessment for Stroke Patients (CASP) :~        -  for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive~          disorders (6 functions: language, apraxia, short-term memory, temporal orientation,~          impaired spatial/visio-construction and executive functions);~        -  the CASP can be used in most patients, including those with severe disorders of~          expression and moderate problems with comprehension, The format of these tests has been~          adapted so that severe disorders of expression (essentially left-hemisphere CVA), and~          left spatial impairment (right-hemisphere CVA) do not affect the ability to take the~          test. Its validity in terms of appearance and content were verified in 2011.~   "
88052|NCT01904786|"~     During the birth process certain conditions can cause oxygen delivery and/or blood flow to~     the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage~     occurs in two phases. The first occurs at the time of injury when brain cells in the~     affected area 'die'. There is nothing that can be done about this. The second phase of~     injury occurs over the next few days. This second phase is caused by inflammation and~     release of toxic chemicals from the injured site. Cooling the baby to a temperature of 92.5°~     F, for 3 days has been shown to reduce the second phase of injury and bran death. All babies~     will receive the benefit of cooling. Although cooling helps it does not completely stop the~     second phase of injury.~      Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate~     the sleep-wake cycle. It has the potential to stop the second phase of brain injury by~     inhibiting inflammation and release of toxic chemicals. The reason for this research is to~     find out if melatonin can or cannot improve the outcome of babies with this kind of brain~     damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of~     six doses of medicine will be given. The baby's brain function will be assessed by an EEG,~     brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are~     routinely used as part of standard care for patients with this kind of problem. The only~     difference is that half the babies enrolled in the study will get the drug called melatonin~     and the other half will receive placebo. The dose of melatonin being used in the study is~     higher than the amount normally produced by the body. No side-effects of this dose have been~     reported in other research studies using melatonin in newborn and premature babies.~   "
88053|NCT01904773|"~     This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's~     Disorder. There will be an up to 21-day screening period in which subject eligibility will~     be determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of~     AZD5213 will be assessed during a 1- week period.~      In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses~     (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed~     through six consecutive four-week crossover periods. Each subject will receive both AZD5213~     and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of~     study drug.~   "
88054|NCT01904760|"~     Reconstruction using microvascular free tissue flap has been an important management in~     patients with maxillofacial tumor. It is often characterised as long operation time, more~     traumatic and require restriction of patient's head movement postoperatively in order to~     prevent disruption of microvascular anastomosis. Agitation and delirium are common in~     patients with free flap surgery, which may lead to serious consequences such as self~     extubation, injury or even failure of the flap.~      Dexmedetomidine is a sedative and co-analgesic drug with high specificity for~     α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use~     after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on~     preventing delirium has not been proved.~      The investigators hypothesized that the use of Dexmedetomidine would reduce emergence~     agitation and prevent delirium in patients after free flap surgery.~   "
88055|NCT01904747|"~     This study is intended to quantify the effect of food on the extent of absorption of~     palbociclib.~      The caloric content of the food and the time of the meals with respect to palbociclib~     administration may influence the capacity of the body to absorb the drug.~      High and low calorie meals will be given to the subjects 30 minutes before palbociclib~     administration as 2 of the 3 conditions to compare with completely absence of food in the~     body when dosing (fasted).The third condition to test and compare with fasted stage will be~     the administration of food before and after palbociclib administration.~      This information will help the program to decide wether or not the presence of food when~     dosing palbociclib help with its absorption and to what extent it does help. Based on the~     collected information, a recommendation about the administration of palbociclib with food~     will be provided to patients.~   "
88056|NCT01904734|"~     This study aims to explore whether men with low testosterone levels, due to altered brain~     regulation of male hormone function, who have been previously treated with testosterone,~     respond as well as men who have not been so treated to clomiphene citrate, an agent commonly~     used for female infertility that has been shown to improve male hormone secretion in some~     cases.~   "
88057|NCT01904721|"~     This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia~     (AGA).~   "
88058|NCT01904708|"~     Phenylketonuria (PKU), an inherited genetic disorder, can cause irreversible brain damage,~     declined executive function, and autistic tendencies unless a phenylalanine (Phe) restricted~     diet is consistently maintained throughout life. Promoting anabolism, the uptake of free~     amino acids from the extracellular space, is a key component to maintaining plasma~     phenylalanine concentrations within treatment range among patients with PKU. Exercise~     promotes muscle protein synthesis and anabolism, but the effect on blood phenylalanine~     concentrations in patients with PKU has not been reported.~      Our objective is to assess the impact of an acute bout of moderate intensity exercise on~     protein oxidation and plasma amino acid concentrations, as a potential adjunctive therapy~     for patients with PKU.~      The investigators hypothesize that moderate intensity exercise decreases amino acid~     oxidation, increases muscle protein synthesis, and promotes tissue uptake of essential amino~     acids, thereby lowering plasma phenylalanine concentrations in patients with~     Phenylketonuria.~   "
88059|NCT01904695|"~     The research of clinical effectiveness assessment is to explore the causal relationship~     between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment,~     the research takes the Resistant Hypertension (RH) as example to study the causal inference~     methods under real world.~   "
88060|NCT01904682|"~     The study will enroll low risk MDS patients who need red blood cell transfusions and who are~     refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study~     is to determine whether oral rigosertib treatment results in hematological improvements~     according to the 2006 International Working Group criteria in these patients. The study will~     also record any side effects that may occur during the study.~   "
88061|NCT01904669|"~     The purpose of this study is to assess the feasibility of conducting an Internet-based~     prospective pregnancy study with preconception enrollment with women completing daily~     journals for up to 12 months while trying to conceive and weekly through pregnancy if it~     occurs.~   "
88062|NCT01904656|"~     The purpose of this project is to implement and evaluate an intervention to increase and~     sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and~     older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based~     participatory research (CBPR) in combination with two CRC interventions that have been~     developed and piloted with community partners to improve CRC screening~   "
88063|NCT01904643|"~     This phase I trial studies the side effects and the best dose of lenalidomide when given~     together with combination chemotherapy in treating patients with relapsed or refractory~     acute myeloid leukemia. Lenalidomide may stop the growth of acute myeloid leukemia by~     blocking blood flow to the cancer. Drugs used in chemotherapy, such as mitoxantrone~     hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     lenalidomide and combination chemotherapy may be an effective treatment for acute myeloid~     leukemia.~   "
88064|NCT01904630|"~     The project will use exome sequencing to search for genetic predispositions for familial~     colorectal cancer (CRC). Except for certain syndromes there is today no good method for~     identifying individuals with a hereditary high risk for CRC (about 25% of the cases). There~     is currently no routine screening of the population in Norway for CRC today. Coloscopy,~     which is the most reliable method, is demanding with respect to resources, it can be~     painful, and may have complications. This project will attempt to find genetic determinants~     for identification of individuals with increased risk for familial CRC. Such methods will~     reduce unnecessary medical examination of unaffected family members, and will make it easier~     to focus health services on individuals with increased risk. This will represent a~     significant contribution towards improved health reduced death rate caused by CRC. The~     project includes research on the ethical aspects, in particular challenges related to how~     feedback to donors is handled.~   "
88065|NCT01904617|"~     This randomized controlled trial aims to compare three groups of intravenous fluids and~     their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal~     saline 3) 250 mL/hr of 5% dextrose in normal saline~   "
88066|NCT01904604|"~     Food allergy occurs when the immune system reacts against foods. The immune system is the~     part of the body that protects us from illness and germs, but it can also cause allergies.~     Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries.~     There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be~     severe and life threatening. The only way that you can prevent an allergic reaction is to~     avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and~     people can be accidently exposed to peanut proteins. Treatment for accidental exposure~     include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin)~     which must be carried at all times. DBV Technologies has developed an epicutaneous delivery~     system, a patch that puts the peanut protein on the skin.~   "
88067|NCT01904591|"~     This study will enroll 10 adults with a chronic spinal cord injury. The investigators will~     image their damaged motor tracts using MRI tractography scanning, and the investigators will~     formally assess their ASIA motor level at the outset of the study. Then, the investigators~     will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These~     are two vitamins known to be anti-oxidants. After one year the investigators will repeat the~     MRI scans and ASIA assessments to determine if their has been any change in the appearance~     of motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot~     study the investigators are primarily concerned with establishing safety of this~     intervention, with a view to conducting a larger and more rigorous controlled trial in the~     future. The investigators also have a small hope that in fact some improvement might be~     found with vitamin treatment.~   "
88068|NCT01904578|"~     Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads~     to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe~     technique that can be easily taught to menopausal women so that they apply it as a self-care~     method and a manager of sleep disruption. The purpose of the present study was to evaluate~     the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind~     randomized clinical trial was performed on 120 qualified menopausal women at the age of~     41-65 years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI~     ).Participants were randomly assigned to an acupressure group, a sham acupressure group and~     a control group by two time randomized method (systematic and simple randomized). These~     interventions were carried out for 4 consecutive weeks. Participants in acupressure group~     and sham acupressure group learned to carry out acupressure technique as a self care at home~     with the simultaneous massage techniques that were to be performed 2 hours before sleep,~     whereas only conversation was used in the control group. The statistical software package~     for social science (SPSS) Version 17 was used for data analysis.~   "
88069|NCT01904565|"~     This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia~     and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue~     sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary~     purpose would be to assess the safety and efficacy of this approach along with local tumour~     regressions and subsequent tumour downstaging, thereby enabling a near total removal of~     these tumours following the hyperthermia and proton beam therapy.~   "
88070|NCT01904552|"~     The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on~     the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement~     devices.~   "
88071|NCT01904539|"~     This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid~     (OCA) in healthy volunteers and patients with liver disease.~   "
88072|NCT01904526|"~     Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces~     pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.~   "
88073|NCT01904513|"~     The primary objective of this pilot study is to determine if consumption of a probiotic~     yogurt causes reduced levels of environmental toxins in a group of school-aged Tanzanian~     children. The secondary objective is to determine the levels of environmental toxins in~     Tanzanian children and compare these to literature values of levels believed to negatively~     affect health and development. The third objective is to analyze the intestinal microbiota~     of the children and to determine if consumption of a probiotic yogurt has a significant~     affect on the microbiota composition.~   "
88074|NCT01904500|"~     Obesity has become an increasingly prevalent public health problem in the United States,~     reaching epidemic proportions. According to 2009 CDC epidemiologic data on obesity in the~     United States, 35.7% of the United States population is considered overweight or obese.~     Currently, on the review of the literature, over 20% of pregnancies in this country are~     complicated by maternal obesity. Obesity has been well demonstrated to be correlated with~     numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational~     diabetes, and increased rates of operative delivery. Moreover, obesity, irrespective of~     pregnancy, has been demonstrated to be an independent risk factor for the development of~     postoperative surgical site infections. Development of such infections can have both~     consequential long-term medical sequelae for patients and economic impacts on the health~     care system at large. Cefazolin, a first generation hydrophilic cephalosporin whose~     clearance is exclusively mediated via the kidneys unchanged, is used as pre-operative~     antibiotic prophylaxis for cesarean deliveries. The current accepted standard of care is to~     administer 2 grams of cefazolin within 60 minutes of skin incision. Studies of drug~     concentrations of cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric~     patients have shown that therapeutic concentrations may not be achieved in both tissue and~     plasma. Limited data exist in pregnancy. Therefore, it is the goal of this study to~     investigate whether obese patients presenting for cesarean delivery require an increased~     dosing amount of pre-operative antibiotic prophylaxis. This study will randomized women with~     a pre-pregnancy body mass index of 30 kg/m2 or more who are presenting for their scheduled~     cesarean delivery to receive either 2 grams or 3 grams of cefazolin for pre-operative~     antibiotic prophylaxis. By drawing blood at specific time points in the peri-operative~     period and extracting adipose tissue samples during cesarean delivery, this study will~     investigate the pharmacokinetics of cefazolin in both the plasma and tissues of the obese~     gravida.~   "
88075|NCT01904487|"~     Background:~      - This study is being done to examine the role of a chemical GABA in the brain of alcohol~     dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous~     system. It helps induce relaxation and sleep and balances the brain by inhibiting~     over-excitation. Several studies have reported that anxiety disorders such as panic attacks,~     seizure disorders, and numerous other conditions including addiction, are all related to low~     GABA activity. Therefore, we will examine differences in GABA levels between healthy~     controls and subjects with alcohol addiction. Studies such as this are important to the~     understanding of the role of GABA in alcohol addiction.~   "
88076|NCT01904474|"~     This study aims to:~      I. Determine the e-therapeutic intervention program effectiveness compared with the standard~     treatment protocol, on both the behavioural change (treatment adherence and promotion of~     healthy lifestyles) and health impact (weight control and quality of life), based on a~     population of adolescents followed at Paediatric Obesity Clinic (POC) of Hospital de Santa~     Maria (HSM), Lisbon (Portugal).~      II. Evaluate the health profile, treatment adherence, lifestyle and impact of weight on~     quality of life of this population.~      III. Test the usability of an e-therapeutic platform for obese adolescents and their~     families.~   "
88077|NCT01904461|"~     The long-term objective of this study is to prove:~        -  the equivalence of the number of post-operation hemorrhages, and maybe a decrease of~          the number of secondary hemorrhages~        -  the decrease of pain and quicker re-feeding~        -  an easier haemostasis~        -  the simplification of the tonsillectomy surgical kit~        -  the decrease of dissection time~   "
88078|NCT01904448|"~     To purpose of this feasibility study is to demonstrate the safety and efficacy of the~     Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in~     children without the diagnosis of neurofibromatosis type II (NFII) that have either~     experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary~     to cochlear or cochlear nerve disorders. These conditions can include: developmental or~     acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic~     cochlear ossification or cochlear malformation.~      This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24~     Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical~     procedure, tolerance of device stimulation, and the potential for auditory benefit beyond~     that experienced with their CI. This study will provide the preliminary experience for a~     larger scale clinical trial.~      Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development~     of sound awareness and improved speech understanding among children implanted with the ABI~     when compared to their baseline skills. Aim 3: Demonstrate the development of oral language~     skills following the use of the ABI that were not evident prior to its use.~   "
88079|NCT01904422|"~     Periodontitis is an infectious disease that destroys the tooth supporting tissues and~     triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk~     factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting~     and maintaining an appropriate glycemic control. It has been reported an average decrease of~     0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus~     untreated. It is not has been established that periodontal treatment type in spaced sessions~     (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24~     hours), has a greater impact on glycemic control in type 2 diabetes patients.~      Objective: To evaluate the effectiveness of intensive periodontal treatment modality as~     compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.~   "
88080|NCT01904409|"~     The primary objective of this study is to assess the efficacy of rifaximin SSD versus~     placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death~     due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis.~      Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for~     the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver~     cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.~      Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for~     24 weeks.~   "
88101|NCT01904123|"~     The goal of this clinical research study is to find the highest tolerable dose of WP1066~     that can be given to participants with recurrent cancerous brain tumors or melanoma that has~     spread to the brain. The safety of this drug will also be studied.~      WP1066 is designed to target the STAT3 pathway in cancer cells, which makes these cells~     divide, increases new blood vessels to the tumor, causes the cancer cells to move throughout~     the body and brain, and avoids them being detected by the immune system. Targeting this~     pathway may cause the immune system to kill the cancer cells.~      This is the first study using WP1066 in humans.~   "
88102|NCT01904110|"~     The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM~     group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal~     osteoporotic women(Phase IV)~   "
88103|NCT01904097|"~     The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to~     adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct~     current stimulation.~   "
88081|NCT01904396|"~     There are some adults with skeletal muscle weakness (called myopathy) and heart muscle~     weakness (called cardiomyopathy) who have low blood levels of a compound called carnitine~     as a cause of their problems. Carnitine is very important to energy production in muscles.~     In fact, there are reports of some people with carnitine deficiency who have developed~     myopathy and cardiomyopathy that was completely reversed with carnitine treatment. The main~     objective of our project is to determine the number of patients who have carnitine~     deficiency as a cause of their myopathy and cardiomyopathy. The investigators will be~     measuring carnitine levels in 1000 patients with cardiomyopathy and will describe the~     specific features in all the study patients to see if there are any trends that may help us~     predict which patients with muscle weakness are at risk of developing low carnitine levels.~     The investigators will be treating patients with low carnitine levels with carnitine and~     observing them to see if their cardiomyopathy and their muscle weakness improve. Knowing the~     exact percentage of myopathy and cardiomyopathy patients with carnitine deficiency may allow~     for screening of patients in a cheap and targeted way to treat the serious complication of~     this condition, including heart failure and sudden death.~   "
88082|NCT01904383|"~     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as~     add-on therapy in patients with type 2 diabetes mellitus.~   "
88083|NCT01904357|"~     The primary objective of this study is:~      • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years~     (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV)~     delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.~      The secondary objectives of this study are:~        -  To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of~          cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with~          modeling data for adolescents aged 13-17 years (inclusive) and historical data from~          adults receiving a single 2g dose of cefazolin.~        -  To assess the safety of a single dose of cefazolin in children aged 10 to 12 years~          (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the~          DUPLEX® drug delivery system for surgical prophylaxis.~   "
88084|NCT01904344|"~     The NXT_SLEEP study, bringing together industry partners, research groups and (home) care~     providers, tackles will develop a next generation sleep-monitoring platform that consists of~     less obtrusive sensors, and that delivers complete and useful information regarding the~     physiological parameters relevant for sleep-related breathing disorders.~      These new and innovative sensors need to be validated in a clinical setting where they will~     be benchmarked with the classical sleep monitoring systems. In order to compare the novel~     sensors with the classical monitoring system, the investigators use existing technologies~     that capture simultaneously the acquired signals of different physiological parameters~     relevant for sleep-related breathing disorders.~   "
88085|NCT01904331|"~     The purpose of this study is to assess the prevalence of cardiac dysfunction and~     (undiagnosed) heart failure in women registered in general practice with a history of breast~     cancer who received chemotherapy and / or radiotherapy as compared to a matched female~     control population.~   "
88086|NCT01904318|"~     A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation~     clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152~     mesylate after oral administration in healthy male volunteer~   "
88087|NCT01904305|"~     This study aims to determine whether interpretations of bronchoscopic results enable~     physicians to successfully predict the presence of pneumonia in traumatically injured~     patients.~   "
88088|NCT01904292|"~     This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and~     safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile~     Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg)~     will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with~     body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks.~     Tocilizumab was administered every 10 days until pre-planned interim analysis was performed~     and changed to Q2W in participants with body weight <30 kg.~   "
88089|NCT01904279|"~     This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and~     safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with~     polyarticular-course juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra~     subcutaneously every 2 or 3 weeks for 52 weeks.~   "
88090|NCT01904266|"~     This research project intends to look at the effect that a certain type of freezing~     injection, called a paravertebral block, has on the pain after an operation for breast~     cancer, the amount of pain relief that is needed and the side effects from this pain relief.~     The hypothesis is that the paravertebral block, in combination with a general anesthetic~     will reduce both pain scores and the amount of strong pain killers (opioids) that is needed.~     This will reduce the side effects of the pain killers such as nausea and vomiting.~      This will be assessed by comparing it a general anesthetic with pain killers given through~     the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who~     agree to be involved in the trial, will be randomly allocated into two groups: both groups~     will receive a block, then a standardised and optimised general anesthetic. In one group~     however the block is simply a small injection under the skin (a sham block), whereas the~     other group will receive a proper paravertebral block prior to this. Both groups will~     receive opioids as necessary, depending on both their bodies reaction during the surgery and~     their pain scores when they wake up.~      The paravertebral block is a very safe procedure with a very low side effect profile, and~     many studies have shown a benefit in breast cancer surgery. The investigators would like to~     assess this in our own practice. The block is normally inserted under some light sedation,~     with freezing into the skin initially. It is normally very well tolerated. The sham block~     will also be performed under light sedation and freezing into the skin. The patients will~     not be able to tell whether they are having the sham block or the paravertebral block,~     because both are very well tolerated. There are no potential complications from the sham~     block.~   "
88091|NCT01904253|"~     The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or~     topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on~     survival, how much time may pass without disease progression, and the safety of TAS-102.~   "
88092|NCT01904240|"~     The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic~     factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed~     throughout the entire nervous system including the central, peripheral, and enteric nervous~     system. There is evidence that inflammation plays a major role in neurodegeneration in PD.~     In both the striatum and substantia nigra of PD patients activated microglia were found and~     proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An~     inflammation-driven animal model has emerged and has been widely accepted as a model of the~     disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found~     on the outer membrane of gram negative bacteria and humans are exposed to LPS through the~     intestinal tract. The intestinal tract and thus the enteric nervous system serve as a~     conduit to the central nervous system. It has been posited that the inflammatory process~     could gain access to the lower brainstem via the vagal nerve and then ascend through the~     basal mid- and forebrain until it reaches the cerebral cortex, producing various pre-motor~     and motor symptoms of PD along the way. LPS may be one of the inflammatory triggers involved~     in this process. Systemic exposure to bacterial endotoxin can be determined by measuring~     plasma LPS binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr~     stage 2) and age matched controls found that the PD subjects had a significantly lower mean~     level of plasma LBP compared to control subjects. The aim of the research plan is to~     establish LBP as a potential biomarker for PD across a spectrum of disease severity.~   "
88093|NCT01904227|"~     An randomized clinical trial to investigate whether among adult borderline patients (18 - 40~     year), intensified inpatient short term (12 weeks) inpatient Dialectical Behavior Therapy~     (DBT) is more effective in declining the proportion of patients that show~     suicidal/self-harming behavior in the first 3 months of treatment, compared to standard~     outpatient DBT, and whether this difference between the groups is sustained at 6 and 12~     months.~   "
88094|NCT01904214|"~     to quantify the effect of different degrees of renal impairment on the pharmacokinetics of~     BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop~     dosing recommendations for subjects with renal impairment~   "
88095|NCT01904201|"~     The health of the immune system in HIV infected people is currently determined from a blood~     test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells~     play a critical role in an immune response. Studies have shown that low numbers (below the~     normal range) of CD4 T lymphocytes indicates a defect in the immune system. Conversely, the~     number of CD4 T lymphocytes within the normal range generally indicates a normal immune~     system. When a person is infected with HIV the CD4 T lymphocytes are attacked and destroyed~     and the numbers decline meaning that the immune system can no longer effectively protect the~     body from infection or cancers. However, when the HIV infected person is successfully~     treated with Highly Active Antiretroviral Therapy (HAART) the CD4 T lymphocytes numbers~     increase and may end up in the normal range but the immune system may still not function~     properly as a number of these cells are incapable of functioning properly.~      It would be interesting to know how functional the immune system is rather than the number~     of cells. For this, the QuantiFERON® Monitor (QFM or CST007) test is an experimental~     diagnostic test used in this study to measure the immune function from people infected with~     HIV. The objective of this study is to evaluate the usefulness of the QFM test in HIV~     infected people compared with uninfected people by measuring the function of the immune~     system. The QFM test measures interferon-gamma released in the plasma following incubation~     of heparinised whole blood with a combination of stimulants. As immune function is directly~     influenced by cells with actively replicating HIV an additional research test called the HIV~     Reservoir Test will be included to better understand the level of immune function in each~     study subject.~      How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical~     Study Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks~     from Dr. Gatpolintan' office).~      Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be~     assessed, including data presentation, within an average period of 1 year after study~     subject enrollment.~   "
88096|NCT01904188|"~     The aim of this project is to test the utility of the Gene-Z device on clinically obtained~     bodily fluid samples taken from patients with suspected sepsis based on having three of four~     positive Systemic Inflammatory Response Syndrome markers. Specimens will be collected by~     Sparrow Laboratories and McLaren Greater Lansing laboratories, processed and stored for~     analysis at a later date to determine if the microbial pathogens identified by current~     methods of culture, as well as pathogen susceptibility to antibiotics by culture results,~     can be identified by the GeneZ technology accurately. It will not affect current patient~     care nor impact patient care, which will continue in the standard fashion today for sepsis.~     Results will be compared to standard culture results and antibiotic sensitivities.~   "
88097|NCT01904175|"~     Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The~     investigators and others have shown that less toxic preparative regimens (reduced intensity~     or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions,~     significantly broadening the population of patients who may be offered this therapy to those~     who are older and more infirmed. The field is now focusing on the period post transplant for~     approaches to immune recovery leading to improved outcomes.~      The primary objective of this registry is to catalogue data from patients who undergo~     standard of care reduced intensity allogeneic transplantation.~   "
88098|NCT01904162|"~     Previous clinical studies have indicated that finafloxacin is well-tolerated with few~     treatment-related adverse events. As a part of the clinical development of finafloxacin,~     other PK studies are required to determine the effect of other variables on the PK profile~     of finafloxacin. This study aims to determine the effect of age and gender on the~     pharmacokinetic profile of finafloxacin.~   "
88099|NCT01904149|"~     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed~     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in~     comparison to the single agents (and placebo for the single dose phase only).~      Approximately 600 female patients presenting moderate to severe pain after a total/subtotal~     abdominal hysterectomy are eligible to be randomised provided that they experience moderate~     to severe pain on the day after surgery.~   "
88100|NCT01904136|"~     The goal of this clinical research study is to learn about the safety of giving a kind of~     immune cells called natural killer (NK) cells with standard chemotherapy and an allogeneic~     stem cell transplant (using cells from a donor). Researchers also want to learn the highest~     tolerable dose of NK cells that can be given.~      Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous~     cells. Researchers believe that the NK cells you receive from the donor may react against~     the leukemia cells in your body, help eliminate leukemia, and prevent disease relapse.~   "
88104|NCT01904084|"~     The purpose of this study is to evaluate function, pain and radiographic evaluation in~     patients treated with volar locked plating versus Hoffman II bridging external fixation in~     patients with extraarticular distal radius fractures, AO/OTA type A~   "
88105|NCT01904071|"~     Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department~     (ED) with intravenous opiates. However, this class of medications may cause deleterious side~     effects. An alternative analgesic approach involves regional anesthesia. The investigators~     attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could~     be safely performed in an ED setting, (2) whether UPNBs would be more effective than~     standard treatment in controlling pain from HFx and (3) which of two UPNBs was superior for~     pain relief.~      A convenience sample of patients with an isolated HFx and a pain score > 5/10 were enrolled~     and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block~     (UFNB), (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients~     indicated their pain from 0 (no pain) to 10 (extreme pain).~   "
88106|NCT01904058|"~     The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a~     13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the~     effect of daily dosing with UDCA in combination with LUM001 or placebo.~   "
88107|NCT01904045|"~     Aim of this study is to investigate whether in patients following kidney transplantation (>6~     months after transplantation), the intra-patient variability of levels of tacrolimus is~     comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily~     (Advagraf), with each regimen for 3 months.~   "
88108|NCT01904032|"~     This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3~     supplementation on depressive symptoms, self-management, and blood pressure in approximately~     180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting~     adult women who are eligible to participate will be randomly assigned to either a weekly~     dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active~     comparator of 5,000 international units of vitamin D3 for six months. Participants will~     complete approximately four in-person study visits and several telephone visits throughout~     the six month trial period, where the researchers will assess depressive symptoms, diabetes~     self-management, and systolic blood pressure.~      Aim 1: To determine the effect of vitamin D supplementation on depressive symptoms (primary~     outcome), self-management (secondary outcome), and systolic blood pressure (exploratory~     outcome) compared to placebo.~      Hypothesis: Women receiving vitamin D supplementation will report fewer depressive symptoms,~     increased diabetes self- management mediated by depression improvement, and have a lower~     systolic blood pressure compared to those taking placebo at three and six months follow-up.~      Aim 2: To explore the mechanistic effect of vitamin D supplementation on inflammatory~     biomarkers and their association with depression.~      Hypothesis: Women receiving vitamin D supplementation will have a decrease in inflammatory~     biomarkers which will be associated with fewer depressive symptoms compared to those taking~     placebo at three and six months follow-up~   "
88109|NCT01904019|"~     Comparison of functional outcome at 3 years after trapezio-metacarpal arthroplasty with~     trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition.~   "
88110|NCT01904006|"~     Previous studies in human and different mammals have proved that the embryo group culture~     (in the same culture medium drop) using a reduced volume is associated with a better embryo~     development. This is due to the effect of different autocrine and paracrine factors secreted~     by the embryos. Besides, previous studies with embryos from human and other mammals have~     shown that a high oxygen concentration may have a negative effect on embryo quality due to~     the generation of reactive oxygen species, which cause oxidative stress. The embryo culture~     at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.~      The purpose of this study is to evaluate the combined effect of the embryo group culture and~     the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments.~     The specific goal is to compare the embryo group culture in a reduced volume of medium at a~     low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen~     tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK~     Medical®), whereas the second condition will be applied using a Heracell incubator~     (Heraeus®).~   "
88111|NCT01903993|"~     This multicenter, open-label, randomized study will evaluate the efficacy and safety of~     Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small~     cell lung cancer after platinum failure. Participants will be randomized to receive either~     Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per~     meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be~     continued as long as participants are experiencing clinical benefit as assessed by the~     investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration~     attributed to disease progression.~   "
88112|NCT01903980|"~     Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with~     acute pleuritic chest pain and therefore must be an important differential diagnosis for~     patients in emergency department (ED). The knowledge of characteristics symptoms and correct~     management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary~     embolism, pericarditis or acute coronary disease.~      Despite the importance of this entity, only fewer than 40 cases have been reported since~     1957, when the condition was first described.~      We have seen a couple of similar cases in our institution during a short period of time, and~     we suspect that these numbers doesn`t mean the real prevalence of epipericardial fat~     necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that~     tried to estimate an incidence of this entity.~   "
88122|NCT01903850|"~     The purpose of this study is to prospectively assess the efficacy and safety of spray~     cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or~     debridement for the treatment of clinically significant obstructions of the central airways.~     The primary effectiveness endpoint is the proportion of subjects with a minimum of 25%~     improvement in luminal patency following SCT treatment and mechanical intervention 30 days~     (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the~     reporting of all adverse events.~   "
88123|NCT01903837|"~     This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted~     in 2 parts. The study duration for each subject will be approximately 33 weeks and will~     include 25 study visits.~   "
88124|NCT01903824|"~     This is a single center, double-blind, placebo and positive-controlled, randomized, partial~     6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401~     (5, 25, and 125 μg) following single-dose administration to healthy male and female~     subjects.~   "
88113|NCT01903967|"~     Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500~     persons. Pituitary tumours are usually considered as benign. However, local invasion is~     reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence~     leading to multimodal therapy is reported in about 15% of cases. These tumours are~     considered as aggressive pituitary tumours and present a distinct biological and clinical~     entity with continued growth despite multimodal therapy, including surgery and radiotherapy~     (McCormack et al., 2011). Whilst these tumours have malignant potential, the term of~     pituitary carcinoma is strictly reserved for those rare tumours (0.2%) with demonstrated~     craniospinal or systemic metastases (Heaney, 2011).~      Pituitary aggressive and malignant tumours are very difficult to control and ultimately~     prove to be lethal. It was suggested that early aggressive treatments (chemotherapy,~     radiotherapy) may control progression and occurrence of metastases. However, these~     therapeutic options are associated with important side effects limiting their use and the~     prediction of pituitary tumor behaviour remains a challenge. At the diagnosis, clinical~     signs are not specific and the results concerning proliferative factors (Ki-67 and P53),~     putative oncogenes (PTTG) conflict from one series to another.~      In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated~     a prognostic pathological classification based on histological and radiological data (J.~     Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive~     tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the~     combination of radiological signs of invasion and 2 of 3 signs of increased proliferation~     (Ki-67 index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection).~      It is now widely accepted that cancer is a clonal disease, which arises from a single normal~     cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To~     identify the role of these DNA alterations, we conducted array CGH analysis limited to 13~     prolactin pituitary tumours, from frozen fragments, and identified allelic loss of~     chromosome 11 associated with aggressiveness and malignancy (Wierinckx et al., 2011).~      To confirm these encouraging results we propose to conduct a study on a large series of~     tumours, fixed and embed, and to be correlated the results to clinical data.~   "
88114|NCT01903954|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve~     patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose~     followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys~     (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48~     weeks depending on response. Treatment-experienced patients categorized as relapsers,~     partial responders and viral breakthrough patients to previous pegylated interferon and~     ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination~     with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as~     null-responders to previous pegylated interferon and ribavirin therapy will be assigned to~     treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.~   "
88115|NCT01903941|"~     Aerobic physical activity attenuates systemic inflammatory activity in individuals with~     cardiovascular risk.~   "
88116|NCT01903928|"~     This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in~     subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are~     also assessed.~   "
88117|NCT01903915|"~     There were a few studies about the relationship of structural or functional abnormalities of~     brain and social cognitive dysfunctions in patients with schizophrenia. In addition, default~     network, which increases activity during mental explorations referenced to oneself including~     remembering, considering hypothetical social interactions, and thinking about one's own~     future, may be associated with social cognitive dysfunctions in patients with schizophrenia.~     Therefore, we will investigate the dysfunction of default network in patients with~     schizophrenia compared with healthy controls and the effect of default network dysfunctions~     on the social cognition in patients with schizophrenia.~   "
88118|NCT01903902|"~     The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting~     balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.~   "
88119|NCT01903889|"~     The study employs a quasi-experimental design in 8 public health centers in southwest Uganda~     offering care and treatment (C&T) services. In 4 health centers, a basic intervention is~     introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women.~     They are charged with counseling C&T clients on FP; offering condoms, pills and injectables;~     and referring clients for other FP methods. In the other 4 health centers, the basic~     intervention is introduced along with an intervention for constructive male engagement in~     HIV and FP services. This includes training of C&T providers on gender-based influences on~     health behaviors; provision of couples' HIV testing and FP counseling services; and~     community-based education for men to promote gender equitable norms and male participation~     in health services.~   "
88120|NCT01903876|"~     This is a study to determine whether a theoretically-driven web-based 3-hour intervention~     designed for male college students called RealConsent is effective in increasing prosocial~     intervening behaviors and in preventing sexual violence perpetration. Sexual violence~     programs for this population have been implemented for decades in the United States, but a~     program that is web-based and incorporates the bystander education model has never been~     implemented or tested. In this study, male college students will be recruited online,~     enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the~     intervention, investigators will ask questions about their intervening and sexually coercive~     behaviors and other theoretical and empirical factors related to the study outcomes.~     Investigators will survey the young men again at post-intervention, and at 6-months~     follow-up to determine whether young men in the RealConsent program intervened more often~     and engaged in less sexual violence compared to young men in the comparison condition. The~     main hypotheses are: (1) college men in the RealConsent program will report more instances~     of prosocial intervening; and (2) college men in the RealConsent program will report less~     sexual violence against women.~   "
88121|NCT01903863|"~     The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP)~     administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically~     ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP~     transfusions during their ECMO course. The investigator proposes that scheduled FFP may~     maintain pro and anticoagulation balance thus mitigating the need for expensive and~     dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all~     products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The~     subjects will be neonatal and pediatric patients requiring ECMO support for any reason in~     the pediatric and pediatric cardiac critical care units. Subjects will be randomized to~     receive every other day FFP infusions or FFP administration per current standard of care.~     ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a~     small risk that study subjects may receive more FFP transfusions and therefore have the~     increased associated risks however it is also possible that these subjects may benefit from~     less ECMO circuit changes and/or fewer transfusions of all blood products.~   "
88125|NCT01903811|"~     This randomized phase II trial compares how well two different doses of carfilzomib work~     when given with dexamethasone in treating patients with multiple myeloma that has come back~     after a period of improvement or has not responded to treatment. Carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is~     not yet known whether a higher or lower dose of carfilzomib works better when given with~     dexamethasone.~   "
88126|NCT01903798|"~     This clinical trial will test two new therapies for the treatment of alcoholic hepatitis.~     Patients who respond to the current standard of care therapy for alcoholic~     hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly~     assigned to either continue on standard therapy, or, to begin treatment with rilonacept in~     combination with standard therapy. Patients who are non-responders to the current standard~     of care therapy after 1 week of treatment will be randomly assigned to standard of care or~     to begin treatment with mycophenolate mofetil in combination with standard therapy. Patients~     will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for~     up to five months after completing therapy (6 months total).~   "
88127|NCT01903785|"~     Athletes using asthma medications called β2-agonists win a disproportionately high number of~     medals at Olympic Games. Due to a large variety in the genes that affect how individuals~     respond to β2-agonists, the investigators will look at variations in the genetic response to~     these medications by dividing athletes into high-responders and low-responders. The~     investigators will then compare athletic performance after the inhalation of β2-agonists to~     placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing~     mechanics. Due to differences in their anatomy females may decrease the energy needed for~     breathing during high-intensity exercise to a greater extent compared to male athletes after~     the inhalation of β2-agonists.~   "
88128|NCT01903772|"~     The additional effect of inspiratory muscle training as an adjunct to a general exercise~     training program in patients with COPD with inspiratory muscle weakness will be studied. The~     main hypothesis is that inspiratory muscle training combined with an exercise training~     program improves functional exercise capacity more than an exercise training program without~     the addition of an inspiratory muscle training program.~   "
88129|NCT01903759|"~     The principal aim of this study is to help obstetricians to diagnose chorioamniotic~     infection early, in cases of premature rupture of the fetal membranes before 34 WA, by~     proposing earlier and more specific markers of infection than FBC and CRP. The aim is to~     reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the~     newborn,.~      If the kinetics profile of one or several markers correlates strongly with the diagnosis of~     chorioamnionitis, it could be used in clinical practice, possibly in the context of another~     clinical study.~      The results of the study presented here are destined to be published in obstetrics journals.~   "
88130|NCT01903746|"~     The epidemiology of this study aims and outcome of patients with septic shock in the~     intensive care unit (or versatile) of the North-East region in france as well as the~     modalities of care.~   "
88131|NCT01903733|"~     The objective of the study is to provide long term access to bosutinib treatment and assess~     long term safety, tolerability and duration of clinical benefit, without any formal~     hypothesis testing; therefore, there is no formal primary endpoint.~   "
88132|NCT01903720|"~     This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant)~     in patients with macular edema associated with branch retinal vein occlusion.~   "
88133|NCT01903707|"~     The aim of this project is to undertake a randomized placebo controlled trial of cognitive~     remediation therapy (CRT) that focuses on working memory training in a sample of community~     based patients with chronic schizophrenia or other psychoses.~      Cognitive deficits are a problem for many people with schizophrenia. This study will use~     computerized cognitive remediation training (which the participant can carry out at home)~     over a period of a few months.~   "
88134|NCT01903694|"~     Principal objective: to evaluate the effect of the combination pravastatin - sorafenib~     versus sorafenib alone on overall survival in patients with hepatocellular carcinoma~     developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.~      Secondary objectives: evaluate the effect of this treatment on progression-free survival,~     the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT~     HEP)~   "
88135|NCT01903681|"~     There is increasing evidence that chronic sleep disorders in children with autism spectrum~     disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with~     disturbed melatonin secretion and melatonin administration has been shown to be effective in~     these populations. For children who have difficulties swallowing a tablet, Neurim has~     developed an age-appropriate Melatonin formulation in the form of mini-tablets which have~     the same dissolution profile as the Circadin® tablets product, thus should produce the same~     melatonin concentration-time profile with the same effects. This study concerns the~     pharmacokinetic study.~      The purpose of this study is to :~        -  Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations~          and urine 6-SMT excretion in children aged 2 up to and including 17 years with~          neurodevelopmental disorders with sleep disturbances.~        -  Establish the concentration-time profile of saliva melatonin concentrations and 24 hour~          6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose~          administration in children aged 2 up to and including 17 years with neurodevelopmental~          disorders with sleep disturbances.~        -  Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin®~          mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental~          disorders with sleep disturbances.~   "
88136|NCT01903668|"~     Step 1: Identification and characterisation of the TREM1L protein from samples already~     available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of~     TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods~     for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a~     larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)~   "
88137|NCT01903655|"~     The mechanisms of oxidative stress and inflammation involved in mood disorders are factors~     of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular~     senescence and are reflected by alterations in systemic gene expression detectable in~     leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically~     significant markers. The identification of new genetic markers will make it possible to~     improve evaluations of the severity and somatic consequences of depressive syndromes.~   "
88138|NCT01903642|"~     The hypotheses of our research are based on the fact that various pathological states,~     infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through~     different pathways, even though the clinical presentation can be identical. The~     identification of biological markers specific to an etiology would therefore allow a faster~     diagnosis and improve care for patients. We thus took an interest in the three groups of~     diseases most frequently responsible for an inflammatory syndrome, infections, cancers and~     auto-immune diseases. To achieve this, various methods will be used.~   "
88139|NCT01903629|"~     Passive video capsule endoscopy is the criterion standard for small-bowel diseases but~     cannot be used for the large gastric cavity.This blinded prospective study investigates the~     accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients~     with gastric symptoms and indication for upper GI Endoscopy.~   "
88140|NCT01903616|"~     This study investigates the longitudinal course of developmental patterns in movement and~     participation in life activities (MPLA) of young children with cerebral palsy (CP) in~     Taiwan. Additionally, the predictors in the initial stage in determining the final~     developmental patterns in movement and participation in life activities MPLA of these~     children will be identified.~   "
88141|NCT01903603|"~     The primary goal of this study is to establish and evaluate an image-based biomarker for the~     impaired motor control and sensory information processing present in Cerebral palsy (CP)~     patients~   "
88142|NCT01903590|"~     The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT)~     procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.~   "
88143|NCT01903577|"~     Robotic surgery holds the potential to overcome many of the ergonomic challenges posed by~     laparoscopic surgery. In this study, we propose to quantify this potential ergonomic benefit~     by measuring electromyography (EMG) and instrument motion analysis of subjects performing~     surgical tasks using robotic assistance versus standard laparoscopic instrumentation.~      Hypothesis: We hypothesize that surgeons will experience significant, measurable ergonomic~     advantages when performing tasks using robotic surgery when compared to conventional~     laparoscopic tools.~      Study design: Subjects for the study will include three groups of varying degrees of~     training - (1) novice laparoscopists/novice roboticists, (2) expert laparoscopists/novice~     roboticists, and (3) expert laparoscopsts/expert roboticists. Subjects will perform the~     following tasks (chosen based on their reliability and validity in previous studies). Each~     task will be performed with standard laparoscopic instrumentation and with the da Vinci~     Surgical System.~        -  Inanimate (dry lab): Fundamentals of Laparoscopic (FLS) peg transfer, pattern cutting,~          intracorporeal suturing.~        -  Animate (porcine lab): laparoscopic bowel resection and anastomosis, robotic bowel~          resection and anastomosis.~        -  Human (clinical case): any laparoscopic or robotic procedure (preferably laparoscopic~          bowel resection and anastomosis, robotic bowel resection and anastomosis).~      Outcome measures:~        -  Time to completion of tasks~        -  EMG: peak amplitudes, % maximum voluntary contraction and frequency analysis~        -  NASA Task Load Index scores~        -  Subject-Reported Qualitative Data from surveys~        -  Quality analysis of tasks (e.g., pattern cutting accuracy, % knots tied securely) for~          dry lab and animate lab tasks only)~        -  Instrument motion analysis of tasks (for dry lab and animate lab tasks only)~   "
88144|NCT01903564|"~     Fetal research and clinical practice has been hampered by a lack of suitable investigational~     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy~     and physiology, but it has significant limitations for assessment of cardiac rhythm. The~     proposed study will allow us to investigate fetal magnetocardiography (fMCG) as a new tool~     for the study of normal and abnormal fetal heart rate and rhythm, with a goal of~     demonstrating probable benefit from use of the device in patients with serious fetal~     arrhythmia. We propose a study that will last 1-2 years and will provide data to aid in~     assessing the safety and effectiveness of fMCG for diagnosis and management of patients with~     abnormal fetal heart rate and rhythm. We hope that the data from the study will support a~     Humanitarian Device Exemption (HDE) application for the subject device. The safety and~     efficacy study designs are described below. High-risk subjects will undergo echocardiography~     as part of their routine clinical management, and our results will be compared to the~     echocardiography results, as well as with postnatal ECG, when available. (Since many~     arrhythmias resolve prior to birth, either due to resolution of disease or due to treatment,~     only a limited number of diseases allow postnatal comparison). For rhythms that persist~     after birth, the diagnostic utility of fMCG and echocardiography will be assessed by~     computing the sensitivity (Sn) and specificity (Sp) relative to postnatal ECG for the~     following prenatal modalities: (i) the fMCG, (ii) the original (referral) echo, (iii) if~     available, the in-lab echocardiogram at the time of the fMCG study. Secondary endpoints will~     assess changes in diagnosis and in clinical management due to the additional information~     provided by fMCG, compared to the information provided by echocardiography alone.~   "
88145|NCT01903551|"~     The aim of the study is to evaluate whether loco-regional analgesia reduces post operative~     pain compared to intravenous analgesia, in patients undergoing cardiac surgery in~     minithoracotomy. All patients will be randomized to receive locoregional analgesia~     (treatment group) or intravenous analgesia (control group), at the end of the cardiac~     intervention.~   "
88146|NCT01903538|"~     Insufficient cognitive control over emotional distracters is characteristic for major~     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is~     associated with this deficit. In this study the investigators assess the effect of a~     decrease of dlPFC activity in healthy subjects by cathodal transcranial direct current~     stimulation (tDCS) on cognitive control.~      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators~     determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive~     control in healthy subjects. To assess the cognitive control the investigators use a delayed~     response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of~     varying valence.~   "
88170|NCT01903226|"~     The aims of this study are to assess the effects of medium versus high intensity 12-week~     adjusted training programs on physical capacity in persons with incomplete SCI, early after~     discharge from primary rehabilitation, and to investigate if the training program induces a~     more active lifestyle in terms of increased daily energy expenditure.~   "
88171|NCT01903213|"~     To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical~     settings.~   "
88147|NCT01903525|"~     In recent years, media attention has focused on the long-term sequelae of repeated~     concussive episodes in professional athletes. The growing understanding of the damage done~     by what was once considered a ding during a game or match, and the neurologic consequences~     of playing through or returning to play too soon has led to additional interest in and~     concern for pediatric athletes (18 or under) who experience sports-related concussions~     during game or practice play.~      Because it has only been in recent years that the full scope of damage done by repeated~     concussive episodes has come to light, very little research has been done on treatment of~     concussion in either adults or children. Brain injuries in children can be especially~     problematic, as the brain may continue to develop until the child reaches the age of 24 or~     older, so concussion during this time of development may be particularly damaging.~      Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and~     algae. DHA is known to improve development of the eyes and brain in young children. It is~     thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally~     and causes very few harmful side effects, it may be a useful compound in the treatment of~     pediatric concussion.~      This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric~     population. The investigators' primary aim is to determine acceptability of randomization~     for this compound as well as rate of enrollment given our clinical population. The~     investigators' secondary aim is to examine preliminary outcomes. The investigators~     hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to~     full recovery and return to play and a shorter time to resolve balance disturbance. These~     are good, albeit unvalidated, clinical indicators of concussive recovery.~   "
88148|NCT01903512|"~     This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal~     derangement of the temporomandibular joint (TMJ).~   "
88149|NCT01903499|"~     The satiety effects of beef will be compared to beans. Beef is hypothesized to be more~     satiating than beans.~   "
88150|NCT01903486|"~     Would systemic steroids be an effective treatment in early variants of achalasia?~   "
88151|NCT01903473|"~     The immune system has offensive and defensive capacities. In bone marrow transplantation,~     offensive cells in the donor grafts may attack host's organs, leading to a complication~     known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to~     combat this tricky situation. Nevertheless, some patients do not respond to this therapy.~     Recently, it has been shown that immune system cells having defensive capacities can help in~     preventing the occurrence of a GVDH.~      This study aims to evaluate if these protective cells together with a non-standard~     immunosuppressor can improve the clinical condition and suppress the activity of the~     offensive cells in the graft.~   "
88152|NCT01903460|"~     The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and~     tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus~     placebo on the biochemical markers and pruritus associated with Alagille Syndrome.~   "
88153|NCT01903447|"~     Internalizing psychopathologies (IPs) involving depression and anxiety are among the most~     prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent~     to which individual patients respond is quite heterogeneous. Little information exists,~     particularly in the biological domain, which helps to explain individual differences in~     treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic~     Affect Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used,~     'gold standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive~     behavioral therapies (CBTs) - are equally effective for both anxiety and depressive~     disorders, and appear to change brain activity in the same areas within the FLARES circuit.~     The overarching goal of the project is delineate what are common versus specific FLARE brain~     targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might~     better predict response to both and to a specific modality of treatment. This experiment~     integrates emotion and its interaction with cognition across several stages of emotional~     experience, encompassing studies that probe sensitivity to acute and potential threat and~     automatic and volitional forms of affect regulation in relation to the FLARES brain network.~      We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking~     treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized~     as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT.~     Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES~     function, will be measured before and after each treatment. Specifically, the project will~     examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on~     NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI~     and CBT treatment? Such findings can be used to guide the right patients to the right~     treatments with the highest likelihood of success. They also elucidate a~     pathophysiologically-driven mechanistic model of where and how treatments work in the brain~     and thus hasten the development of new treatments that target the underlying pathophysiology~     across internalizing conditions.~   "
88154|NCT01903434|"~     The purpose of this study is to measure and compare the amounts of the study drug~     evacetrapib found in the blood after taking two different formulations. The study has 3~     periods. Participants will take each formulation by mouth at least once. A minimum of 14~     days will pass between study drug doses. The safety and tolerability of the study drug will~     also be examined. Information about any side effects that may occur will also be collected.~     This study will last approximately 6 weeks.~   "
88155|NCT01903421|"~     Many elderly patients undergoing surgical procedures already have impaired cognitive~     (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia,~     may benefit from modified anesthesia techniques. It is estimated that one in eight people~     age 65 and older has Alzheimer's disease. More so, nearly half of people that are 85 years~     or older have Alzheimer's disease. Currently, both spinal (regional) and inhalational~     (general) anesthesia, are used in patients undergoing common urological, orthopedic, and~     general surgical procedures. Inhalational anesthesia has been associated with higher risk of~     memory impairment in experimental (animal) and human studies. However, currently, there are~     simply no large or good enough studies to be sure that inhalational anesthesia is~     responsible for causing dementia and Alzheimer's disease.The proposed study investigates if~     elderly patients (65 years and older) undergoing spinal anesthesia (patient is awake or~     slightly sedated) are less likely to develop dementia and Alzheimer's disease for up to 2~     years after surgery, when compared to inhalational anesthesia (patient is kept asleep with~     gas anesthetic). The investigators will also test all patients for the presence of~     apolipoprotein (ApoE-Îμ4 type of gene that is present in 15-20% of patients), and~     beta-amyloid tau protein (present in cerebrospinal fluid) that are known risk factors for~     Alzheimer's disease. The particular strength of this study is that it takes into account~     whether the frequency and/or severity of dementia and Alzheimer's disease is different in~     patients with and without these markers. The investigators believe that this study will make~     a major contribution to better understanding of development of Alzheimer's disease.~   "
88172|NCT01903200|"~     The objective of the study was to evaluate the safety and plasma concentration changes of~     quetiapine after multiple oral administration of FK949E (extended-release formulation of~     quetiapine) in elderly patients with major depressive disorder (MDD).~   "
88173|NCT01903187|"~     The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and~     effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with~     drug-resistant uncontrolled hypertension.~   "
88156|NCT01903408|"~     For patients with prostate cancer and a high risk of lymph node involvement or confirmed~     pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option.~     However, conventional radiotherapy of the pelvis has limited by gastrointestinal and~     urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy~     of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose~     is given during each session to the prostate or the prostate bed and to confirmed lymph node~     metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are~     required, and continuation during radiotherapy and for a further two years are strongly~     recommended.~   "
88157|NCT01903395|"~     BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk~     for colorectal cancer as well. Nevertheless, participation in the German national screening~     program stagnates at 2-3 percent per year even in this high-risk population.~      AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which~     take up a preventive colonoscopy.~      METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly~     certified cancer centers and office-based gastroenterologists from all over Germany.~     Index-patients with colorectal cancer of different stages are asked to hand over the study~     material to their relatives, consisting of an invitation to a nurse-led counseling on~     preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the~     study sites next.~   "
88158|NCT01903382|"~     Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been~     shown for different populations, different diseases and in different countries, but not for~     surgical patients. Aim of this study is therefore to investigate the association between~     circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients~     undergoing surgery and general anesthesia.~   "
88159|NCT01903369|"~     The investigators would like to compare the stiffness inside and outside nerves using a~     special type of ultrasound imaging called shear wave elastography. Shear wave elastography~     is a special form of ultrasound as the pictures taken are in colour. An ultrasound machine~     has different ways of taking pictures of inside the body: one is by measuring the brightness~     of different body parts (often referred to as the B-Mode scan), the pictures taken in this~     way are the same as those you may have seen of unborn babies inside their mum's tummies;~     another way is by measuring the stiffness of different body structures which is how shear~     wave elastography works. The investigators hope that this new technology will help doctors~     to see the parts of the body that are important to them.~   "
88160|NCT01903356|"~     The primary objective of this study is to monitor the safety profile of Trajenta Duo in~     Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.~   "
88161|NCT01903343|"~     The aim of the study is to assess the accuracy of shear wave elastography in volunteers.~     Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained~     using an ultrasound machine. It may be easier to think of shear wave elastography as a~     special type of ultrasound imaging which gives doctors a colour picture of body structures~     based on their stiffness.~   "
88162|NCT01903330|"~     This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage~     colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to~     Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with~     recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World~     Health Organization (WHO) grade IV malignant gliomas, GBM).~   "
88163|NCT01903317|"~     The purpose of this research study is to find out more about the relationship between~     vitamin D and psoriasis.~   "
88164|NCT01903304|"~     This is a prospective, randomized controlled nutrition intervention trial to determine~     immunological impact of high olive oil consumption in elderly. Aging is associated with~     impaired immune response which contributes to higher incidence of infections in elderly.~     Previously the investigators have shown that the type of fatty acids in the diet influences~     the immune response. In particular, reducing consumption of fats high in n-6 fatty acids has~     been shown to improve the immune response in aged. Very few studies have evaluated the role~     of olive oil, the main oil consumed as part of the Mediterranean diet on the immune response~     of elderly. The investigators hypothesize that high olive oil consumption will improve~     immune function in elderly. In addition, the investigators will investigate the effect of~     high olive oil consumption on gene expression of relevant pathways in circulating~     mononuclear cells, as well as on cognitive function.~   "
88165|NCT01903291|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a~     12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated~     with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The~     secondary objectives of this study in this study population are to assess the impact of DMF~     over a 12-month period on patient-reported outcomes (PROs) and health economic-related~     outcomes and to evaluate additional clinical outcomes at Month 12.~   "
88166|NCT01903278|"~     This study is to confirm the potential effects and assess the safety of a new bio-product~     Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and~     Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated~     with Interferon.~   "
88167|NCT01903265|"~     TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have~     shown promise as a treatment of fibromyalgia, but the drug required new formulation~     technology for bedtime use. The present trial was designed to assess the safety and efficacy~     of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.~   "
88168|NCT01903252|"~     The purpose of this research study is to compare the medication TP05 to the medication~     Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and~     tolerability of TP05. This study will investigate whether TP05 is as good as (non-inferior~     to) Asacol™.~   "
88169|NCT01903239|"~     The purpose of this study is to determine the narrowest excision margin for head and neck~     Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network®~     (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an~     acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are~     evaluated.~   "
88174|NCT01903174|"~     This study is intended to support previous positive results of the AeroForm™ Patient~     Controlled Tissue Expander System for breast reconstruction~   "
88177|NCT01903135|"~     Rationale of the BIO-OHS study (Prevalence of Obesity Hypoventilation Syndrome):~      The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly~     assessed in the general population. Actually, this prevalence has been assessed in patients~     referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in~     patients already diagnosed with sleep apnea. The purpose of this study is to determine the~     prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical~     laboratories for regular follow-up medical analysis.~   "
88178|NCT01903122|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Cevimeline 30 mg under fasted conditions~   "
88179|NCT01903109|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Cevimeline 30 mg under fed conditions~   "
88180|NCT01903096|"~     The strong demand for primary care (PC) services in Spain exceeds resources. Part of this~     demand is due to the increasing number of anxiety, depression, and somatization disorders~     that affect the general population. These disorders, commonly known as emotional disorders,~     are very common in Spanish PC settings, they are poorly detected by physicians, rarely~     receive adequate treatment (if they receive treatment it is mostly drugs instead of~     psychological treatment), they generate a highly frequent use of PC services, a greater~     burden than physical diseases and tend to become chronic without treatment.~      Other countries have successfully put psychological techniques in PC into practice (in the~     United Kingdom the program known as Improving Access to Psychological Therapies has~     obtained very positive results) in order to correctly diagnose and treat emotional~     disorders. The results obtained in terms of symptoms, quality of life, diagnosis, etc., have~     been better than the usual treatment offered in PC services, involving no side effects,~     fewer relapses, and lower costs in the long term.~      The general aim of this study is to test how well a psychological treatment program for~     anxiety, depression, and somatization disorders works in PC and to compare the results~     obtained after seven 90-minute group sessions (every to two to four weeks approximately, for~     a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar~     results to the ones already obtained in other countries are expected to be found.~      Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression~     and/or somatization disorder (diagnosed with a simple and short questionnaire) will~     participate in this study.~      Participation will be voluntary and confidentiality will be guaranteed. Half of the~     participants in the study will be randomly assigned to receive their usual care and the~     other half will receive psychological treatment, within the same health care centre. Since~     it is a double-blind study, neither the health professional nor the patient will know~     which treatment will be applied. Psychological assessments will be carried out before and~     after receiving treatment and participants will be followed up at 3, 6 and 12 months.~      Participation will pose no risks different from the typically present when receiving usual~     treatment. The aim of this study will be to maximize benefits and reduce potential harms~     (principle of proportionality).~   "
88181|NCT01903083|"~     The goal of this study is to evaluate the safety of combination treatment that includes~     chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.~   "
88182|NCT01903070|"~     This is a bi-centric, prospective, open study comparing the effects of linagliptin on active~     GLP-1 concentrations in subjects with renal impairment compared to subjects with normal~     renal function.~   "
88183|NCT01903057|"~     Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs),~     infectious diseases that affect millions of poor people in countries in the developing~     world. Trachoma is an eye infection that can lead to painful scarring of the eyelids and~     blindness later in life. LF can lead to swelling of usually the limbs (elephantiasis).~      Trachoma and LF are preventable and treatable diseases. One important treatment strategy is~     annual Mass Drug Administration (MDA): Communities receive drug treatment once a year.~     Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.~      Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for~     trachoma and LF, where three drugs would be given at one time, would reduce costs and~     decrease the burden on the health system.~      Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be~     recommended, we would have to demonstrate that the safety profile of this treatment with~     three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA~     (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the~     same day) showed that the safety profiles were comparable; but the results of the study were~     not statistically significant and we could not use them to make an official recommendation.~      The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL~     study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable,~     an official recommendation for combined MDA with azithromycin, ivermectin and albendazole~     can be drafted.~      We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and~     exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5~     years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.~      Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller~     clusters for sufficient power (average household size is 5 people), b) placebo to~     double-blind participants and study staff for azithromycin, c) the study area will have~     undergone fewer previous rounds of MDA for LF and none for trachoma, and d) smartphones for~     data entry.~   "
88184|NCT01903044|"~     The purpose of this study is to determine whether autologous bone marrow-derived stem cells~     are effective in the treatment of lower extremity ischemia.~   "
88185|NCT01903031|"~     This study will look at a method of hormonal birth control, called the NuvaRing, and~     specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use~     a hormonal birth control method (specifically oral pills, patches, and injections) and take~     ARVs have shown that ARVs interact with the hormones released by the birth control~     medication. These interactions may cause the birth control to be less effective at~     preventing pregnancy. There is also concern that hormonal birth control can increase HIV~     spreading to others, but more studies are needed to determine if this is true. The~     investigators do not know whether the NuvaRing and ARVs interact when they are used~     together, so this study will look to see if certain ARVs (efavirenz and~     atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us~     to determine if NuvaRing is safe and effective for women with HIV infection who are taking~     ARVs. The study will also include HIV-infected women who are not on ARVs but will use the~     NuvaRing to show us what the hormone levels are like in a similar group of women not on~     ARVs.~      Vaginal rings are also currently being studied to deliver anti-HIV medications that may~     prevent HIV acquisition, and to provide birth control over a longer period of time (more~     than 1 month). Since vaginal rings will become more commonly used to administer medications,~     the investigators want to better understand the potential for drug interactions with drugs~     given vaginally. This study will also help us understand the potential for drug interactions~     between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing.~     Additionally, this study will help us understand how hormones released from a vaginal ring~     affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of~     the female genital track, and the immune system within the genital tract, all of which may~     affect the chances of spreading HIV.~   "
88186|NCT01903018|"~     A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced~     Squamous Cell Carcinoma of the Head and Neck~   "
88187|NCT01903005|"~     The purpose of this study was to assess safety, efficacy, and treatment retention following~     extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX)~     sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary~     efficacy and safety studies of OX219.~   "
88188|NCT01902992|"~     This study will assess efficacy and safety of intraseasonal specific short-term~     immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or~     rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant~     IgE-mediated allergic sensitization against birch pollen. The term intraseasonal means~     that patients will start with immunotherapy treatment during the birch pollen season, i.e.~     when the already experience allergic symptoms.~   "
88198|NCT01902862|"~     The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how~     well a participant can stand a particular medicine or treatment; ability to be used) of~     bortezomib in combination with rituximab standard therapy (medicine or medical care given to~     a participant for a disease or condition) in participants with relapsed or refractory (not~     responding to treatment) follicular lymphoma (a cancer of the lymph nodes [or tissues] in~     follicle).~   "
88189|NCT01902979|"~     Obesity is one of the most important determinants of quality of life and function. People~     with lumbar spinal stenosis may be at increased risk of obesity given walking limitations.~     Spinal stenosis is a very common degenerative condition in people over 45. People with this~     condition have pain and numbness in the legs during walking, and therefore avoid physical~     activity. Lack of physical activity is related to weight gain and increased risk of chronic~     disease. Objective: The objective of this project is test a new e-health (online) pedometer~     and nutrition intervention aimed at promoting weight loss and increasing physical activity~     in overweight and obese individuals with spinal stenosis. Methods: The investigators will~     recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these~     people will receive the 12-week intervention, and the other half will receive usual care (no~     intervention). In Weeks 1 and 6, people in the intervention group will meet with a~     Registered Dietitian and an Exercise Physiologist for personalized sessions. They will~     receive a pedometer and instructions on how to log in to the e-health site~     (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website~     each week for a nutrition education session, a weekly step goal, and tips. The investigators~     will look to see whether people in the intervention group show greater change in physical~     activity, body composition and quality of life compared to the individuals who received~     usual care. Relevance: The increasing number of people with spinal stenosis represents a~     huge health care burden in Canada. This intervention could provide a new treatment option~     that would increase mobility, quality of life, and potentially alleviate the need for~     expensive treatments like surgery. E-health interventions provide an opportunity for~     patients to take an active role in their own health, and promote behaviour changes that will~     result in healthier Canadians less likely to access care in the future.~   "
88190|NCT01902966|"~     The goal of this clinical research study is to learn how many patients with advanced,~     recurrent, incurable cervical cancer will complete questionnaires about symptoms, any~     anxiety, depression, and/or pain, and the quality of their lives. Researchers also want to~     learn how many of these patients will complete a study treatment of propranolol~     hydrochloride and relaxation and guided imagery sessions.~      Researchers also want to learn if and how propranolol hydrochloride and relaxation and~     guided imagery may affect cancer symptoms and any anxiety, depression, and/or pain, and~     quality of life.~      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.~      Relaxation and guided imagery sessions are a form of relaxing meditation that involves~     tensing and relaxing various parts of your body from your feet to your head. In the guided~     imagery portion, you listen to recordings that are designed to help with calmness, control,~     and decreasing stress.~   "
88191|NCT01902953|"~     45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of~     colon cancer will be included in this study. During colon operation the affected portion of~     the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by~     a pathologist. Analysis of the lymph nodes in the specimen are important because this is an~     important aspect of determining the stage of the cancer.~      Once the standard technique is used for the colon removal operation and the specimen is~     removed it will be injected with two drugs to help identify the lymph nodes. One is a blue~     dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for~     the standard pathologic evaluation. The patient themselves will never be injected with these~     drugs being used for research.~      Following the standard lymph node evaluation, an additional pathologist at an outside~     research facility will further examine the lymph nodes in the specimen using more in depth~     techniques which are above and beyond the standard of care.~      The results of all the pathologic tests will be conveyed to the surgeon of record to help in~     their decision making regarding further treatment.~      The study hypothesis is that radiotracer will be at least as effective as blue dye in~     identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once~     identified, these sentinel nodes can then undergo a more in depth review leading to improved~     staging of colorectal cancer and more accurate treatment.~   "
88192|NCT01902940|"~     So far, only limited data is available regarding the natural course in Congenital Cataract~     Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body~     myopathies (IBM). Several criteria and outcome measures have led to contradicting results.~     The investigators want to retrospectively assess the natural course of the disease in CCFDN~     and IBM patients according to the data recorded during clinical routine visits.~   "
88193|NCT01902927|"~     Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is~     increasing rapidly. The gradual decrease in exercise tolerance is one of the usual~     consequences of COPD that affects the functional independence and quality of life of~     patients.~      In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise.~     Recent studies have shown that most of the physiological mechanisms of psychological factors~     such as emotions, motivation, memory, personality, expectations, or prior experience can~     greatly influence and modulate the perception of breathlessness. It has been proposed that~     the attentional distraction (visual or auditory) during exercise may be associated with a~     decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We~     therefore propose to study the impact of attentional strategies of distraction on the~     perception of dyspnea and walking tolerance in patients with COPD.~      The research hypotheses are:~      i) Compared with exposure to a strategy of negative attentional distraction during exercise,~     exposure to a strategy of positive attentional distraction will improve walking exercise~     tolerance in patients with COPD;~      ii) For a given level of effort, sensory perception and emotional perception will be~     enhanced by exposure to a strategy of positive attentional distraction.~      Ten subjects with moderate to severe COPD will be recruited at the Research Center of the~     Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an~     assessment visit, we will measure complete pulmonary function, body composition and maximal~     functional capacity during a maximal incremental test work performed on a treadmill.~      During two subsequent experimental visits, and after spirometry control, participants will~     perform a walking test performed on a treadmill at an intensity corresponding to 75% of~     maximum effort during maximal incremental test. The test will be carried out in combination~     with a strategy of either positive attentional distraction, neutral attentional distraction~     or negative attentional distraction . The order of the condition will be randomized.~   "
88194|NCT01902914|"~     To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by~     the National Electronics and Computer Technology Center, Thailand.~   "
88195|NCT01902901|"~     This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women~     & partners) seeking pre-conception carrier testing to assess the impact of the program using~     Whole Genome Sequencing (WGS).~        1. The investigators hypothesize that whole genome sequencing will increase the detection~          of carrier status for Mendelian recessive and x-linked conditions.~        2. The investigators hypothesize that parents will act on the knowledge of their carrier~          status by making different reproductive choices than parents who do not receive this~          information.~        3. The investigators hypothesize that the psychosocial risks are increased among parents~          who receive expanded carrier screening using Next Generation Sequencing (NGS) compared~          with usual care.~   "
88196|NCT01902888|"~     This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN®~     Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).~   "
88197|NCT01902875|"~     This clinical Trial is proposed to explore whether preconditioning chemotherapy of~     Paclitaxel+cisplatin(TP)regimen combined with autologous adoptive CIK cell immunotherapy~     could benefit NSCLC patients with a better clinical outcome.~   "
88201|NCT01902823|"~     There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued~     by cancer patients, but no studies have evaluated the effects of CNNs on important~     patient-reported outcomes or indicators of quality of care. This study has two aims:~        1. To assess the feasibility of studying the impact of Aurora CNN Program.~        2. To pilot test the effects of CNN services on patient-reported outcomes and indicators~          of quality of care.~   "
88202|NCT01902810|"~     This efficacy and safety trial will examine the effects and safety of propranolol~     administered to adult patients with severe burn injury. The investigators hypothesize that~     propranolol will provide significant benefit to adults following severe burn injury at doses~     that are safe and do not increase risk of adverse infectious and non-infectious outcomes.~   "
88203|NCT01902797|"~     According to the World Malaria Report, there were significant decreases in the number of~     P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border~     where transmission is low and seasonal and where incidence of Multi-drugs resistant~     P.falciparum parasites is the highest, the same trend has been observed with a clear decline~     in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV.~      Economic development, unprecedented financial support, renewed efforts in vector control, a~     wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin~     based combination treatments (ACT) are the main contributing factors to those successes~     against malaria.~      However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates~     that exhibit resistance to artesunate is threatening those gains . This is characterized by~     a slow parasite clearance rate observed in patients treated with artesunate.~      At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge~     technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low~     parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of~     malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or~     even conventional PCR.~      It seems that a large number of asymptomatic carriers with very low parasites counts (a~     large potential malaria reservoir) go undetected. If confirmed, this might pose the greatest~     obstacle for malaria elimination in the region and containment of artemisinin resistance.~      The purpose of the survey is to further study and understand the epidemiology of malaria in~     the refugee camp population using cutting-edge technology (RT-PCR) .~   "
88204|NCT01902784|"~     Research Protocol Abstract:~      This is a phase II controlled trial (RCT) of a storytelling intervention compared to no~     treatment among surrogates who have participated in a decision to limit life-sustaining~     treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned~     to storytelling (a facilitated elicitation of the experience 2-4 weeks after bereavement)~     or no treatment with follow up monitoring of well-being. Subjects will receive print~     bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks,~     3-months, and 6-months after bereavement.~   "
88205|NCT01902771|"~     DC vaccine manufactured and partially matured using our standard operating procedures,~     developed in collaboration with the HGG Immuno Group, then administered through imiquimod~     treated skin will be safe and feasible in children with refractory brain tumors. This will~     result in anti-tumor immunity that will prolong survival of subjects treated and results~     will be consistent with the outcomes found for subjects treated by HGG Immuno Group~     investigators. Study treatment will correlate with laboratory evidence of immune activation.~     Correlative studies will also reveal targets in the immune system which can be exploited to~     improve response for patients on successor trials.~   "
88206|NCT01902758|"~     This study is being conducted to determine the effectiveness of using two FDA approved~     medications in concert to reduce the likelihood of sickness due to low oxygen levels and to~     reduce the decrement in physical performance at higher elevations. The investigators~     hypothesize that this drug combination will reduce the symptoms of acute mountain sickness~     and improve exercise performance at high altitude compared to placebo.~   "
88207|NCT01902745|"~     There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue~     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms~     experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of~     life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently,~     there are few treatment options for PCRF and existing treatment options are associated with~     significant costs, are a considerable burden on the part of the patient, or have~     unacceptable side-effects. As such, there is a clear need to conduct studies evaluating the~     impact of safe, easy to implement and inexpensive treatments for PCRF in BC survivors.~      Individualized nutritional counseling has been found to be beneficial for decreasing fatigue~     and improving quality of life in cancer patients receiving treatment.However, there is a~     dearth of research examining the use of diet for treating fatigue in cancer survivors. Our~     preliminary data in 40 adult cancer survivors found that fatigue severity was associated~     with decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g.,~     omega-3 fatty acids, as reported in diet records. However, diet records are often not highly~     correlated with actual nutrient concentrations in the body and tend to capture short-term~     dietary habits not long-term patterns. The main objective of this research is to expand upon~     and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical~     dietary study we are conducting by examining key nutrient differences in biological samples~     in the breast cancer survivors. By examining differences in biological samples we will be~     able to explore three key questions, which will directly influence our future interventional~     studies: (1) to determine if there are actual differences in concentrations of key nutrients~     in body tissue and which nutrients these are; (2) to assess if a dietary intervention~     focused on improving fatigue in BC survivors changes baseline levels of key nutrients; and~     (3) what is the effect size and variability of change in key nutrients in body tissue both~     at baseline and after a dietary intervention.~   "
88208|NCT01902732|"~     This clinical trial evaluates the impact of catheter-based measurement of interloabr~     collateral ventilation prior to endoscopic lung volume reduction in patients with~     hetereogeneous emphysema and complete interlobar fissures in high resolution computed~     tomography.~   "
88220|NCT01902563|"~     Background Several studies have shown the effect of osteopathic manipulative treatment on~     neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications~     and improving cranial asymmetry of infants affected by plagiocephaly. Despite several~     results obtained, there is still lack of standardized osteopathic evaluation and treatment~     procedures for newborns recovered in neonatal intensive care unit (NICU).~      The aim of this research is to provide a guideline on osteopathic approach in treating~     hospitalized newborns. Specific evaluation tests and treatments have been developed to~     tailor osteopathic method according to preterm and term infants' needs, NICU environment,~     medical and paramedical assistance.~   "
88221|NCT01902550|"~     The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and~     metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the~     exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in~     healthy participants.~   "
88209|NCT01902719|"~     African Americans represent a particularly vulnerable subgroup of persons with hypertension,~     as they are more likely than Whites to have hypertension, equally as likely to be aware of~     it and to be treated for it, but less likely to achieve blood pressure control while~     receiving treatment. African Americans are also more likely than Whites to suffer end organ~     damage as a result of hypertension. Patients' hypertension self-management behaviors~     (including adherence to prescribed care, self-blood pressure monitoring, lifestyle changes,~     and shared medical decision-making) represent a cornerstone of hypertension therapy.~     Evidence suggests some African Americans with hypertension may experience difficulties~     carrying out positive self-management behaviors, in part due to cultural beliefs and~     practices, knowledge and perceptions regarding the nature and consequences hypertension, and~     lack of systems to support ongoing engagement in prescribed care within their communities.~     Substantial evidence has demonstrated the important role of family and community support in~     improving patients' management of a variety of chronic illnesses.~      The goal of this study is to rigorously test the effectiveness of hypertension~     self-management interventions that engage African American patients, their families, and~     their community-level resources to improve African American patients' blood pressure.~      We hypothesize patients' hypertension control rates may be improved when combining community~     health worker self-management support with other types of hypertension self-management~     skills training.~   "
88210|NCT01902693|"~     Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of~     therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great~     improvement to the health and lives of all people living with HIV, HAART cannot be stopped~     because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the~     remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART~     treatment is stopped the virus comes back (wakes up). It is for this reason that stopping~     HAART treatment is not recommended. However, it may be that other drugs if given with HAART~     could have a stronger effect on the latent virus. There is some evidence from laboratory~     research that suggests that some of the drugs we use to treat certain types of cancer may~     have an effect on the latent virus. The purpose of this research study is to use new~     laboratory research technology to measure the amount of 'latent' virus in people who are~     treated with HAART who then need to use chemotherapy treatments for cancer. We will look at~     whether the levels of HIV virus are reduced in patients having chemotherapy by looking at~     the virus levels before, during and after chemotherapy treatment. We do not know very much~     about how HIV persists in the body despite therapy and unless new approaches are developed,~     removal of the HIV virus from all cells in the body will not be possible.~   "
88211|NCT01902680|"~     This is a pilot prospective biomedical study of interventional type which includes 17~     patients on 24 months (12 months of inclusion and 12 months of follow-up).~      The objective of this study is to verify that the focal therapy technique used (with the~     help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target~     (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30~     days after implantation.~   "
88212|NCT01902667|"~     This is a prospective observational study in which patients with untreated retroperitoneal~     sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients~     who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two~     weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated~     with tumour pathology.~      The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate~     assessment of tumour volume and local staging than CT and will identify areas of altered~     oxygenation, cellularity and perfusion which change in response to radiotherapy before~     tumour shrinkage occurs.~   "
88213|NCT01902654|"~     We analyze retrospectively the relationship between traditional cardiovascular risk factors~     as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we~     compare the results with a control groups of patients with soft tissue disease with no other~     rheumatologic condition.~   "
88214|NCT01902641|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium,~     reversed by low-dose sugammadex. The investigators compare the intubating conditions,~     incidence of postoperative myalgia (POM), as well as patient satisfaction for these two~     muscle relaxants.~   "
88215|NCT01902628|"~     This prospective observational study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients not on~     dialysis with renal anemia. Patients initiated on treatment with Mircera according to the~     Summary of Product Characteristics and standard clinical practice will be followed for 10~     months.~   "
88216|NCT01902615|"~     This multicenter, retrospective, observational study will evaluate the therapeutic~     effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized~     regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical~     practice.~   "
88217|NCT01902602|"~     The objective of this clinical study is to evaluate the influence of the Great~     autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular~     system in patients with resistant hypertension. The primary endpoint is the change in mean~     blood pressure after 10 treatments .~      In addition, data are collected on the immune system as well as for food and sleep quality.~   "
88218|NCT01902589|"~     Helicobacter Pylori (HP) is one of the most common pathogens in humans. This infection can~     present in children with abdominal pain, vomiting and iron deficiency. The treatment is~     usually empiric and includes antibiotic treatment usually Amoxycillin and Clarithromycin or~     Metronidazole. Between 40 to 70 % of the pathogens are resistant to those drugs, and it is~     important to characterize the specific sensitivity of the pathogens in any specific area and~     in pediatric population. The aims of this study is to assess the sensitivity of HP in~     pediatric population in Northern Israel.~   "
88219|NCT01902576|"~     The purpose of this study is to develop and validate endpoint measures that can accurately~     determine whether patients are responding to treatment for chronic Graft-versus-Host Disease~     (GVHD). Hopefully, this will also lead to being better able to predict which patients will~     respond to what therapies.~   "
88224|NCT01902511|"~     This will be a randomized double blind study which will be conducted on patients admitted to~     Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having~     any exclusion criteria will undergo bone marrow examination and liver biopsy at the~     baseline.~      60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30~     patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will~     receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1~     year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd~     day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg~     twice a week for 2 months.~      Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3~     months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).~   "
88225|NCT01902498|"~     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries~     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these~     operations are done each year to help relieve patients' chest pain and to prevent future~     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries~     by sewing on healthy vessels from another part of the body (usually from the leg or the~     chest). Aspirin (a blood thinner) is given to patients once a day after their surgery~     because it stops sticky cells in the blood (platelets) from blocking these new vessels~     (which may lead to a future heart attack).~      Research has shown that aspirin does not work as well in people after they have bypass~     surgery as the investigators might expect (for reasons that are not fully understood). One~     reason aspirin may not work as well after surgery is because the body makes many more~     platelets after surgery than it would under normal circumstances. All of these new platelets~     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The~     investigators believe that giving multiple daily doses of aspirin following bypass surgery~     is more effective at blocking platelet activity than giving aspirin once daily.~   "
88226|NCT01902485|"~     This study will compare immediate to post-abortion start of two progestin-based~     contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical~     abortion who wish to use that method for post-abortion contraception.~   "
88227|NCT01902472|"~     This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and~     following seroconversion, assess the frequency of HIV-1 screening and screening method(s)~     used for evaluation of seroconverters, and collect information regarding whether the~     seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the~     time of seroconversion.~   "
88228|NCT01902459|"~     The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant~     Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during~     intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area)~     and non-cardiac thoracic (chest area) surgery.~   "
88229|NCT01902446|"~     Traumatic injury in rural America is a significant cause of morbidity and mortality, and the~     challenges of a rural trauma system can put patients at unique risk. Prolonged transport~     times to a trauma center, stopping for care at referring hospitals, and longer exposure to~     care-associated factors distinguish rural patients from their urban counterparts.~     Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing~     hospital stay, healthcare costs, and even mortality in the critically injured. The~     investigators propose a pilot study to test the hypothesis that a single dose of oral~     chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will~     decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy~     in intensive care units to prevent airway colonization and subsequent development of VAP.~     Demonstrating safety and effectiveness of prehospital infection control practices could~     significantly improve outcomes of traumatic injury in rural America.~   "
88230|NCT01902433|"~     The purpose of this study is to compare the changes in pain and self-perceived function~     between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of~     soft tissue mobilization using instruments) and a specific exercise protocol that involves~     strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather~     stands for A Stimulation of the body's healing response, describing the physiologic~     process which occurs with Astym treatment. Astym is the trademark name of a non-invasive~     treatment where instruments are applied topically to locate unhealthy soft tissue, and to~     transfer mild to moderate pressure to the underlying soft tissue structures. The aim of~     Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the~     principal investigator and co-investigator have been trained and certified in administering~     the Astym treatment. The specific exercise protocol will involve exercises that strengthen~     the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise~     where the benefit comes from applying a controlled lengthening stress to the muscle and~     tendon.~   "
88231|NCT01902420|"~     Acromegaly is a rare disease caused by growth hormone (GH) secreting pituitary adenoma in~     more than 95% of cases. Acromegaly can be seen sporadically or may be associated with a~     variety of genetic syndromes such as Multiple Endocrine Neoplasia Type 1, Carney Complex,~     familial isolated pituitary adenoma (FIPA) and Mc-Cune Albright Syndrome. The accompanying~     features of these syndromes and family history are helpful in the differential diagnosis.~     Aryl hydrocarbon receptor (AHR)-interacting protein (AIP) gene mutations can be seen~     sporadically as well as in FIPA. But the prescience of the presence of AIP mutation is~     limited by positive family history and early-onset of acromegaly. Furthermore, the~     probability of the patient to be the index case of the family should not be ignored.~      Screening for AIP gene mutation is recommended in patients with pituitary adenomas of~     childhood-onset, GH or prolactin secreting tumors who are diagnosed before the age of 30~     years and positive family history in two or more family members according to present~     evidence in the literature. It is also known that AIP mutation is usually associated with~     more aggressive clinical behavior due to unclarified reasons.~      The prevalence of AIP mutation in Turkish population and types of mutations have not been~     defined previously. The primary aim of the present study is to define the AIP gene mutation~     prevalence and the relation with clinical and tumour behaviour in a subgroup of Turkish~     acromegalic patients. If AIP gene mutation is detected in some patients, it will be possible~     to screen the family of the patient for the presence of AIP mutation or at least for the~     presence of pituitary adenoma.~      Acromegalic patients who are followed in Erciyes University Medical School Department of~     Endocrinology will be enrolled into the study. After DNA isolation, each exon of AIP gene~     including splicing points will be reproduced by polymerase chain reaction (PCR) and will be~     analyzed for the presence of mutation by sequence analysis. The cases will be analyzed~     further in means of clinical features according to presence of AIP gene mutation.~      The prevalence of AIP gene mutation, clinical reflection of presence of AIP mutation will be~     determined and genetic consultation will be given to the carriers of AIP gene mutation at~     the end of the study.~   "
88459|NCT01899430|"~     The purpose of this study was to determine whether liraglutide is more effective than~     metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome~     (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide~     than in those treated with metformin.~   "
88232|NCT01902407|"~     The purpose of this research study is to develop a way of predicting with computers how~     surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA)~     in children with Down Syndrome.~      Subjects will be in the research study for approximately a year. Participation in this~     research study will involves a screening visit and 1 overnight sleep study (PSG) for~     research purposes that will be done before airway surgery. During the research sleep study,~     a measurement will be taken for airway resistance. A research measurement for airway~     resistance will also be done during the clinical sleep MRI. The airway resistance~     measurement will take about 10 minutes and is done during sleep. The airway resistance~     measurement is called critical closing pressure (Pcrit).~   "
88233|NCT01902394|"~     The purpose of this study is to determine if substituting whole grains for refined grains in~     the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria~     in the gut, and has beneficial effects on immune function, digestive health, cardiovascular~     health, regulation of body weight and composition, and vitamin K status.~      The investigators hypothesize that whole grain consumption over a period of 6 weeks will~     alter the gut microflora toward a more beneficial bacterial profile, improve the immune~     response while reducing oxidative stress and inflammatory markers, have favorable effects on~     factors influencing the regulation of body weight and composition,increase bacterial vitamin~     K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption,~     vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is~     hypothesized that, consumption of whole grains will alter statin pharmacokinetics by~     decreasing rate of statin absorption, resulting in more sustained plasma concentrations.~   "
88234|NCT01902381|"~     This pilot clinical trial studies 6, 8-bis (benzylthio) octanoic acid (CPI-613) in treating~     patients with myelodysplastic syndromes who failed previous therapy. Sometimes when~     chemotherapy or biological therapy is given, it does not stop the growth of tumor cells. The~     tumor is said to be resistant to treatment. 6, 8-bis (benzylthio) octanoic acid may~     interfere with the growth of tumor cells and may be an effective treatment for~     myelodysplastic syndromes that did not respond to previous therapy.~   "
88235|NCT01902368|"~     The purpose of this study is to see if it makes sense to test people for celiac disease who~     have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle)~     with celiac disease. The investigators will check to see what differences there are in the~     health and quality of life between those who know they have celiac disease and start the~     gluten free diet and those who do not.~   "
88236|NCT01902355|"~     The purpose of this study is to compare two needle insertion techniques(Seldinger vs.~     modified Seldinger technique) on success rate and complications during central venous~     catheterization.~   "
88237|NCT01902342|"~     Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy~     Korean volunteers.~   "
88238|NCT01902329|"~     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered~     as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of~     the study is to find the maximum tolerated dose (MTD, which is the highest dose that does~     not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia~     (AML). The MTD will be determined by observing the dose-limiting toxicities (the side~     effects that prevent further increases in dose) of SGN-CD33A. In addition, the~     pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.~   "
88239|NCT01902316|"~     Although diabetes has been controlled since insulin became available, it is still considered~     incurable and poses serious threats to human health. Reports have suggested that the~     hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even~     reversed if it could be controlled at an early stage of diabetes. Thus, early detection and~     diagnosis of diabetes and prediabetes are become increasingly important in the treatment and~     prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent~     hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown~     that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in~     the early detection of diabetes. In this work, the investigators have found 8 biomarker~     candidates by developing a standard-free, label-free MS-based proteomics method based on~     standard protein (human serum albumin, the highest abundance protein in human plasma) model~     in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical~     plasma samples to see if there is significant quantitative difference between normal people~     and diabetes patients.~   "
88240|NCT01902303|"~     The purpose of this study is to determine if a new drug treatment is effective to block the~     development of a cold sore lesion following Ultra Violet (UV) exposure.~   "
88241|NCT01902290|"~     The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective~     compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite~     scores.~   "
88242|NCT01902277|"~     ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical~     workflow of the ICU. Effective healthcare resource planning requires reliable (i.e.,~     multicentre) data that can inform on both of these.~      The purpose of this study was to determine the impact of ICU delirium in terms of both~     patients and beds. The study was carried out prospectively, over a one-week period, at adult~     ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).~   "
88243|NCT01902264|"~     The objective of this study is to compare the red blood cell (RBC) and plasma concentrations~     of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus~     levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.~      Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before~     and in the first few weeks of pregnancy has been shown to reduce certain types of birth~     defects. This is important for women who may become pregnant following discontinuation of~     oral contraception. Information about any side effects that may occur will also be~     collected.~   "
88244|NCT01902251|"~     A multiple dose relative bioavailability study in patients with prostate cancer comparing a~     capsule and a tablet formulation of enzalutamide.~   "
88245|NCT01902238|"~     The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation~     for the treatment of pancreatic NET~   "
88246|NCT01902225|"~     This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy~     study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in~     combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or~     refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one~     prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and~     romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best~     response, 8 cycles, disease progression or intolerability whichever comes first. Importanly,~     doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed~     until disease progression or death whichever comes first.~   "
88247|NCT01902212|"~     The objective of this study is to capture gastrointestinal tolerance (GI) information on a~     nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.~   "
88248|NCT01902199|"~     A randomized control trial evaluating a novel smoking cessation intervention in individuals~     at a an inpatient clinic for clients with addiction and concurrent disorders. The~     intervention is based on cognitive bias modification, where participants are explicitly or~     implicitly trained to make avoidance movements by pushing a joystick in response to pictures~     of smoking, and as a result altering their cognitive biases towards smoking and tobacco~     dependence.~      Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce~     reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and~     12 week follow-up.~   "
88249|NCT01902186|"~     Given the high prevalence of bone alteration in the course of HIV infection or~     antiretroviral treatment and the favourable properties of raltegravir the investigators~     designed this pilot randomized and controlled study. Adult female HIV-positive patients on~     successful treatment with tenofovir/emtricitabine plus atazanavir plus ritonavir will be~     randomized either to continue such a regimen or to switch to raltegravir plus atazanavir~     plus ritonavir. Bone mineral density changes will be compared in the two groups at 48 weeks:~     the hypothesis is that removing tenofovir and using tenofovir will increase bone mineral~     density at 48 weeks.~   "
88250|NCT01902173|"~     This phase I/II trial studies the side effects and the best dose of Akt inhibitor GSK2141795~     when given together with dabrafenib and trametinib and to see how well they work in treating~     patients with stage IIIC-IV cancer. Akt inhibitor GSK2141795, dabrafenib, and trametinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving Akt inhibitor GSK2141795 with dabrafenib and trametinib may be a better treatment for~     cancer.~   "
88251|NCT01902160|"~     This phase I trial studies the side effects and best dose of temsirolimus when given~     together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has~     returned or has not responded to treatment. Temsirolimus may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Biological therapies, such as~     brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells~     from growing. Giving temsirolimus with brentuximab vedotin may work better in treating~     patients with Hodgkin lymphoma.~   "
88252|NCT01902147|"~     Recovery following general anesthesia and surgery is a complex issue confounded by the type~     of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient~     co-morbidities, and differing patient and clinician perceptions of what constitutes good~     recovery. In this observational study, quality of recovery and patient satisfaction will be~     measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six~     domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and~     depression), functional recovery (return of activities of daily living), self-assessed~     recovery, and cognitive recovery.~   "
88253|NCT01902134|"~     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed~     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in~     comparison to the single agents (and placebo for the single dose phase only) Approximately~     600 male and female patients presenting moderate to severe pain after an elective primary~     hip arthroplasty are eligible to be randomised provided that they experience moderate to~     severe pain on the day after surgery.~   "
88254|NCT01902121|"~     A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to~     evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and~     administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U~     cartridge.~   "
88255|NCT01902108|"~     The objective of this prospective randomized double-blind study is to evaluate the added~     analgesic value of clonidine to the conventional local bupivacaine wound infiltration in~     posterior spine surgery.~   "
88256|NCT01902095|"~     Dental plaque, known as dental biofilm, is implicated as the primary etiological agent~     responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role~     in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade~     of events leading to the destruction of periodontal tissues.~      Effective plaque control techniques have been suggested that maintain dental biofilm at~     levels compatible with oral health and is the cornerstone for all preventive strategies to~     control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque~     control, different mechanical means have been in use since centuries. However because of an~     inadequacy in plaque removal, different antimicrobial and antiplaque agents have been~     introduced in oral-care products.~      The use of dentifrices has been recommended over the years as the ultimate way of preventing~     the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis~     capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are~     common oral-care products used to eliminate plaque and other deposits from tooth surfaces.~     Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder~     despite its difference owing to the absence of humectants. With the intention to advance the~     knowledge on this issue as well as close the research gap, this study was conducted to~     evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque,~     and inhibiting extrinsic stains.~      A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of~     toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits~     on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were~     used as measures of oral hygiene.~      The current RCT revealed that toothpowder and toothpaste were equally effective in both~     treatment and control groups from clinical perspective however toothpowder showed a~     statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of~     calcium carbonate and essential oils, has demonstrated to be statistically more effective~     than toothpaste in controlling extrinsic dental staining, dental plaque and gingival~     inflammation.~   "
88257|NCT01902082|"~     Currently, there is no proven effective pharmacologic treatment available for patients with~     the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be~     effective in treating several inflammatory diseases. The main purpose of this study is to~     assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with~     ARDS.~   "
88258|NCT01902069|"~     The aims of this project are to:~        1. Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg~          NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity,~          go/no-go tasks and negative outcome learning in heavy drinkers.~        2. Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in~          alcohol consumption.~        3. Preliminary data in the rodent model suggests that rats treated with OEA shift~          preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of~          supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.~   "
88259|NCT01902056|"~     The purpose of this study is to compare the effect on soft tissue thickness of placing~     either a single or double layer of acellular dermal matrix simultaneous with dental implant~     placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker~     tissues that one layer.~   "
88260|NCT01902043|"~     Chronic disease care requires good collaboration between healthcare providers, teamwork,~     self-management education and use of evidence-based medicine. However, such care process is~     complex and often suboptimal. Diabetes, a prevalent chronic disease (~ 9% worldwide) which~     represents a major public health burden in terms of morbidity, disability and mortality, is~     not an exception. Individuals with diabetes, require more health care resources than people~     without diabetes. Improving quality of diabetes care is especially needed to reduce the~     health and societal burden of this disease.~      In the canton of Vaud, Switzerland, a state with more than 700,000 inhabitants, a recent~     population-based study has shown that the prevalence of diabetes was around 7%. Data on the~     quality of diabetes care is scarce and quality of care data are still infrequently and~     unsystematically collected in Switzerland. In addition, when they are available, they rather~     focus on intermediate outcomes as well as clinical and biological cardiovascular risk~     factors. Also, they are not population-based and do not consider patient-reported outcomes.~      In 2010, the Public Health Department of the canton of Vaud initiated the development of a~     regional diabetes program entitled Programme cantonal Diabète (PcD). It aimed both at~     decreasing the incidence of diabetes and at improving care for patients with diabetes.~      To better tailor the program to the healthcare needs of patients and healthcare~     professionals involved in diabetes care, an exploratory study using qualitative methods was~     conducted in 2010. This was followed by a population-based survey conducted in fall 2011 and~     summer 2012. The objectives of this survey were to characterize patients with diabetes and~     assess the quality of the care they received. In addition, to help targeting unmet needs and~     possible areas of improvements, the results of this survey also constituted the baseline~     patients' measurement of the evaluation of the PcD.~      The CoDiab-VD cohort emerged from that initial project. Its specific objectives are 1) to~     follow over time quality of diabetes care, 2) to assess the impact of the PcD on care of~     patients with diabetes, and 3) to evaluate the coverage of the PcD within the canton of~     Vaud.~   "
88261|NCT01902030|"~     Although being a frequent and lethal complication in patients (pts) with hematologic~     malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as~     culture-based methods show low sensitivity especially under the current clinical practice of~     antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing~     biopsies for identification of the underlying infectious organism becomes important.~     However, as culture-based methods only yield results in a minority of patients, using~     non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for~     detection of IA directly in clinical specimens is becoming increasingly important and might~     help to characterize the causative pathogen.~      Therefore the performance of an established Aspergillus-specific nested PCR in biopsies,~     re-section material or pleural effusions is evaluated.~   "
88262|NCT01902017|"~     Injured joints, especially at the elbow, are at risk for permanent motion loss, also known~     as joint contractures. Joint contractures limit the function of an elbow and are a~     recognized complication that occurs often after a traumatic injury. The benefits of early~     motion after injury has helped in preventing joint contractures but there are still several~     patients that develop debilitating joint contractures. Current research suggests that mast~     cells, which are found in the joint, are key in causing joint contractures. Research has~     been done using a medication called Ketotifen. Ketotifen has been linked to stabilizing mast~     cells and preventing the joint contracture. It is hoped that short-term use of this~     medication after an injury will prevent the contracture from occurring.~   "
88263|NCT01902004|"~     The proposed project will evaluate the role of neuroimaging biomarkers of brain aging (i.e.,~     neurodegenerative and vascular brain changes) and mild cognitive impairment in the patterns~     of treatment response to memantine combined with escitalopram compared to escitalopram and~     placebo.~   "
88264|NCT01901991|"~     Each year the Danish mammography-screening programme identifies a large number of patients~     with small non-palpable breast cancers or precancerous lesions. The majority of these~     patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove~     the suspicious lesion completely without removing excess healthy breast tissue. To obtain~     this accurate lesion localization is essential.~      Until today the standard procedure in Denmark has been wire guided localization (WGL).~     Although the method has been utilized for a number of years it has several disadvantages.~     Often inaccurate lesion localization leads to incomplete lesion removal (positive margin)~     and subsequently reoperation. It can postpone the additional systemic treatment, offered~     after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning~     for the patient and the departments involved. The wire needs to be placed on the day of the~     operation, which decreases the flexibility of the procedure.~      The purpose of this study is to test a new method named radioactive seed localization (RSL).~     The method uses a small titanium seed containing radioactive iodine. It will be placed in~     the centre of the lesion, and during the operation, the surgeon can locate it with a~     handheld gamma probe. The seed can be placed a few days in advance, which means a more~     flexible course of treatment. The method seems promising with regards to reoperation rates,~     but it needs further testing.~      Hypothesis:~      RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL.~     Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced~     number of re-operations.~      The study will be performed as a randomised clinical trial, where the two methods will be~     compared to each other. The trial will be performed at the department of breast surgery at~     Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation~     rates, duration of the surgical procedure and the amount of removed breast tissue will be~     compared.~   "
88265|NCT01901978|"~     The purpose of this study is to investigate the changes in subcutaneous adipocyte size,~     number and gene expression after weight loss and to assess whether those changes contribute~     to decreases in ectopic fat accumulation and insulin resistance in women between ages of~     16-32.~   "
88266|NCT01901965|"~     The main aims of the study are (1) to examine the impact of contralateral strength training~     on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of~     cross-education induced by NMES versus eccentric strength training.~   "
88267|NCT01901952|"~     The primary aim of the LIFE study is to compare low-income African American diabetes~     patients in a lifestyle intervention group with those in a standard of care control group on~     change in glycemic control at 12-months. We hypothesize that, on average, participants in~     the intervention group will achieve greater glycemic control at 12-months relative to their~     baseline A1c, than those in the control group.~   "
88460|NCT01899417|"~     The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal®~     total knee replacement system versus standard total knee arthroplasty.~      This study is designed to illustrate the difference in cost between standard total knee~     replacements and the ConforMIS iTotal at a single institution.~   "
88268|NCT01901939|"~     The proposed preliminary study from this interdisciplinary team will provide important~     information about the feasibility and safety of bedside low intensity pedaling exercise~     during hospitalization. The findings from this study are essential to develop high-value,~     effective treatments that can be used by any hospital setting throughout the country. The~     program that investigators are proposing may provide important changes in how disability can~     be prevented in elderly patients who are hospitalized because of an acute illness.~   "
88269|NCT01901926|"~     The purpose of this study is to determine the effects of non surgical periodontal treatment~     on glycemic control in type II diabetics.~   "
88270|NCT01901913|"~     The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose~     levels by delivery of insulin operable in clinical trial settings. The safety of the system~     was proved in previous inpatient and outpatient trials in large number of patients. In the~     current study we aim to optimize post-prandial closed-loop glycemic control by developing an~     automated MD-bolus calculator and to evaluate its safety and efficacy in controlling~     postprandial blood glucose when used together with the MD-Logic artificial pancreas system~     in type 1 diabetes patients.~      The study will consist of a pilot study with two segments and a main study segment. The aim~     of each segment is detailed below:~        1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to~          evaluate the efficacy and safety of different pre-meal bolus dosing compared to full~          closed-loop operation with no meal announcement.~        2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to~          test the optimal distribution of insulin delivery during the meal.~        3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study~          we will use the results and conclusions from the previous two pilot segments to develop~          the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this~          automated insulin bolus calculator will be tested in a randomized cross-over study that~          will compare postprandial glycemic control under MDLAP with and without the use of the~          MD-Bolus Calculator.~   "
88271|NCT01901900|"~     This extension study will provide continuing treatment with secukinumab for up to 3 years~     for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered~     maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The~     study aims to obtain further long term efficacy, safety and tolerability information on~     secukinumab for patients with rheumatoid arthritis.~   "
88272|NCT01901887|"~     The BRAVO study seeks to determine if dietary supplementation with omega-3 highly~     unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors,~     suicidal thinking, negative emotions, and symptoms associated with suicide risk, in a~     Veteran and non-Veteran population that is at risk for suicidal behaviors. This study seeks~     to evaluate the efficacy of omega-3 HUFAs among a representative population of US Veterans~     and non-Veterans already receiving appropriate medical care so that if successful, these~     results can be readily applied to broader populations in the US.~   "
88273|NCT01901861|"~     study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of~     increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2~     diabetes. To this purpose, a standardized mixed meal test will be ingested with or without~     concomitant administration of sitagliptin (100mg).~   "
88274|NCT01901848|"~     Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with~     significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though~     research suggests smoking is linked with PTSD symptoms, existing smoking cessation~     treatments targeting PTSD smokers do not include PTSD treatment. The purpose of this study~     is to examine a treatment that combines evidence based treatment for PTSD (cognitive~     processing therapy, or CPT) with smoking cessation treatment for PTSD and a mobile text~     messaging program. The study objectives are to evaluate feasibility of the treatment and to~     examine effectiveness of CPT and smoking cessation treatment combined compared to smoking~     cessation treatment without CPT. Fifty Veteran smokers with PTSD will participate in~     fourteen study sessions, ending with the final follow-up session six months after the~     scheduled quit date.~   "
88275|NCT01901835|"~     This randomized clinical trial studies media diversion in improving quality of life in~     patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may~     improve mood and quality of life in patients having cancer treatment.~   "
88276|NCT01901822|"~     The hypothesis of this study is that coronally positioned tunnel with acellular dermal~     matrix using a continuous sling suture to secure both the graft and the flap will result in~     better percent root coverage compared to the continuous sling suturing technique to secure~     the graft and the flap separately.~   "
88277|NCT01901809|"~     Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart~     failure patients with a frequency of hospital admissions for acute decompensation and short~     and long term mortality similar to patients with heart failure with reduced ejection~     fraction (HFREF). Patients with HFPEF are often preload dependent and despite admission to~     the hospital for acute decompensated heart failure (ADHF), are typically difficult to~     diurese due to the development of acute kidney injury. No studies have been performed~     evaluating treatment strategies for these patients. We hypothesize that changing the method~     of diuresis and/or the addition of low-dose dopamine for the treatment of ADHF in patients~     with HFPEF will reduce renal injury, resulting in a shorter length of stay, and decrease~     hospital readmissions over the ensuing year. This trial will randomize patients to either~     bolus or continuous infusion furosemide and then to either dopamine or no dopamine. The~     primary endpoint will be renal function at 72 hours as measured by change in GFR. Secondary~     endpoints for readmission, functional capacity, quality of life, and amount of diuresis will~     also be collected.~   "
88278|NCT01901796|"~     We hypothesize that the intervention will: (1) offer a feasible approach for providing~     mental healthcare to pregnant women and have a high level of acceptability by pregnant women~     and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting~     stress; improve parenting competence, coping, and relationship adjustment compared to usual~     care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early~     intervention holds promise for reducing maternal mental health morbidity and its negative~     influences on infants, children, and families.~   "
88282|NCT01901744|"~     The study evaluates contrast sensitivity in older children following surgery for lamellar~     and posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in~     these children who present beyond the amblyogenic age group. These cataracts are often~     compatible with reasonable visual acuity and therefore some surgeons prefer to wait for~     surgery, whereas others tend to operate.~      The study evaluates improvement in contrast sensitivity at different spatial frequencies~     following cataract surgery for lamellar and posterior subcapsular cataracts in older~     children.~   "
88283|NCT01901731|"~     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic~     coil embolisaton) in females with leg varicose veins, who have a proven contribution to~     their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose~     vein surgery.~   "
88284|NCT01901718|"~     Chronic pain patients who experience breakthrough pain in the background of controlled~     persistent pain with opioids will be followed for 3 months in order to assess the safety and~     titration trends in the clinical practice setting of a novel fentanyl sublingual spray~     (Subsys™) for the treatment of breakthrough pain.~   "
88285|NCT01901705|"~     Psoriasis is a common, chronic skin disease for which only remissive, as opposed to~     curative, treatments are available. Traditional Chinese medicine is one of the most~     frequently chosen alternative therapies in China and Taiwan, and psoriasis has been treated~     for centuries with topical and oral herbal preparations. Topical indigo naturalis ointment~     has been reported to exhibit potential anti-psoriatic efficacy. The study objective is to~     investigate pharmacological effect and explore targeting mechanisms of Traditional Chinese~     Medicine (TCM) Indigo Naturalis topical ointment as a single treatment agent in Chinese~     subjects with mild to moderate plaque-type Psoriasis.~      This was a single site, randomized, double-blinded, placebo controlled study of topical~     indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis~     during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation~     and clinical evaluation. The trial was conducted at the China Medical University Hospital~     (CMUH), Taichung, Taiwan. All patients provided written informed consent before inclusion in~     the study. The study protocol was approved by the institutional review board (IRB) of CMUH.~   "
88286|NCT01901692|"~     To evaluate and compare the efficacy and safety of trans-arterial chemoembolization plus~     external beam radiation therapy and sorafenib in patients with hepatocellular carcinoma~     invading major intrahepatic vessels~   "
88287|NCT01901679|"~     The study plans to find out whether Celebrex may be potentially useful to decrease~     inflammation in fat tissues and thereby lower the production of substances such as estrogens~     that may increase the risk of developing breast cancer and lead to a poor outcome of the~     disease.~   "
88288|NCT01901666|"~     CML is a myeloproliferative disorder defined by the presence of the Philadelphia chromosome,~     which arises from the reciprocal translocation of genes on chromosomes 9 and 22.It is rare~     in childhood and accounts for 2-3% of all leukemias in childhood.~      BCR-ABL gene on Philadelphia chromosome results in a 210kd fused BCR-ABL protein with~     constitutive tyrosine kinase activity, and subsequent activation of cytoplasmic and nuclear~     signal transduction pathways including STAT, RAS, JUN, MYC, and phosphatidylinositol-3~     kinase. The ultimate result of such activation is the myeloid proliferation and~     differentiation and suppressed apoptosis.~      Children present with a higher WBC count, otherwise presentation is nearly identical to~     adults. Current treatment include tyrosine kinase inhibitors (TKI) and allogeneic stem cell~     transplant (SCT).Imatinibmesylate inhibits the tyrosine kinase (TK) activity of BCR-ABL1 and~     several related TKs, including c-kit and the platelet-derived growth factor receptor~     (PDGFR). Development of tyrosine kinase inhibitor (TKI) therapy has revolutionizedtreatment~     of CML. Imatinib or second generation TKIs (dasatinib or nilotinib) have become standard~     front-line therapy forchildren and adults with CML and are also important componentsof~     therapy for Ph+ acute lymphoblastic leukemia (ALL).~      TKIs are administered orally and cause a number of side effects including fatigue,~     hypertension, rash, impaired wound healing, myelosuppression, and diarrhea . The overall~     toxicity of TKIs, while less life-threatening than conventional cytotoxic chemotherapy,~     nevertheless is common, and may require dose reduction.Recently, proposed endocrine-related~     side effects of these agents include alterations in thyroid function, bone metabolism,~     linear growth, gonadal function, fetal development, glucose metabolism and adrenal function.~      Growth impairment is one of the major adverse effect of long-term imatinib treatment in~     children with CML. Multiple case reports have demonstrated growth retardation in children~     onimatinib.Imatinibmesylate inhibits the TK activity of BCR-ABL1 and several related TKs,~     including c-kit and theplatelet-derived growth factor receptor (PDGFR). It isthe inhibition~     of TK activity at the non-BCR-ABL sites that couldbe the likely cause for the adverse effect~     on growth. Severalstudies in adults have suggested that inhibition of c-kit,c-fms, and PDGF~     receptors results in modulation of bone metabolism. Other reports are focusing on~     disturbance of the growth hormone (GH) axis as a mechanism for growth impairment. Receptor~     and non receptor TK is expressed at multiple levels in GH-IGF-1 axis including GHRH-R, GH-R~     and IGF-1R. Inhibition of TKs with TKI, at any one of these level, might result in growth~     impairment.~      Various studies are available to show that Imainib therapy may cause short stature in~     children on prolonged treatment but exact mechanism by which this occurs is still not clear.~     Further, no treatment modality has been tried so far, for short stature in these children.~      So, the purpose of this study is to study GH-IGF1 axis in these children and to administer~     GH therapy to GH deficienct children in remission.~   "
88289|NCT01901653|"~     The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different~     dose levels in patients with small cell lung cancer whose cancer has progressed or recurred~     following standard chemotherapy. Once a safe and tolerable dose is determined, the~     anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor~     shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a~     protein that appears to be expressed on the surface of most small cell lung cancers that~     have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form~     of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's~     theoretically provide more precise delivery of chemotherapy to cancer cells, possibly~     improving effectiveness relative to toxicities.~   "
88290|NCT01901640|"~     Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose,~     6-month extension study (parent study : DA8159_EDD_III)~   "
88291|NCT01901627|"~     A multicenter registry to explore the clinical outcome of Chinese adult patients with active~     Ankylosing Spondylitis *AS* treated with adalimumab,prescribed according to the local~     label,in the real world practice~   "
88292|NCT01901614|"~     The purpose of this study is to determine if a new procedure, called laser-assisted lamellar~     anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of~     potential complications after surgery compared to another corneal transplant procedure. The~     current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire~     cornea.~      The LALAK procedure involves transplanting only the top layers of the cornea instead of the~     entire cornea. Only one eye will have this experimental procedure performed. If both eyes~     need to have surgery your doctor will help you decide on the best non-study option for your~     other eye.~   "
88293|NCT01901601|"~     The purpose of this protocol is to compare and develop new surgical technique of~     partial-thickness corneal transplantation for treating corneal opacity. A newly developed~     technique, dovetail laser-assisted lamellar anterior keratoplasty (LALAK), will be tested~     and compared with standard full-thickness corneal transplantation, Intralase-enabled~     keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea~     and does not have the risks associated with conventional IEK. Additionally, optical~     coherence tomography (OCT) will be used to guide the depth of the graft and donor~     dissections.~      The data will be analyzed to understand whether the new technique (LALAK) can repeatedly~     achieve good visual outcomes with lower risk from the operation compared to the visual~     outcomes and risk associated with the current standard of care, IEK.~   "
88294|NCT01901588|"~     This study is trying to see if using precedex pre-operatively prevents emergence delirium in~     pediatric (ages 1-7) patients undergoing strabismus surgery.~   "
88295|NCT01901575|"~     Determine effects of remifentanil conscious sedation in patients undergoing~     Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia~     and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin~   "
88308|NCT01901406|"~     Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old~     population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and~     epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but~     nowadays with technical improvement and surgical instrument renovation, it seems to have~     been changed the surgical indication. Therefore, we plan to evaluate the changes of~     binocular visual acuity, aniseikonia in patients with epiretinal membrane.~   "
88309|NCT01901393|"~     The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to~     ketorolac for the treatment of postoperative pain as measured by patient pain intensity~     (Visual Analog Scale, VAS)~   "
88296|NCT01901562|"~     In this prospective clinical trial, patients who sign an approved informed consent for~     ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the~     study. Consented patients who have been diagnosed with a solitary papilloma within the~     discharging duct will be recruited to have interventional ductoscopy.~      Patients who are identified ductoscopically with a solitary non-sessile papilloma will~     undergo an attempted ductoscopic papillomectomy (DP). Patients with ductoscopic findings~     other than single non-sessile papilloma will undergo standard ductoscopically guided~     microductectomy. The investigators will investigate whether the ductoscopic basket can be~     used as a safe endoscopic extraction instrument without adverse events. Histopathological~     evaluation will be performed to confirm the ductoscopic diagnosis and to determine the~     existence of any malignant tissue.~   "
88297|NCT01901549|"~     This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure~     and left ventricle remodeling progression in patients after acute coronary syndrome.~   "
88298|NCT01901536|"~     This is a research study to evaluate the effectiveness of the Family Foundations program and~     to better understand how families cope with having a new baby. The research questions~     include: What is the effectiveness of the Family Foundations program? How do families cope~     with having a new baby?~   "
88299|NCT01901523|"~     Clinical research, like all science, is self-correcting, with errors detected by the~     scientific community and communicated to the publishing journals, which then relay the~     information (and its resolution) to its readers. If this relaying process fails, science~     grinds to a halt. In this study we are testing its integrity.~   "
88300|NCT01901510|"~     This study first is designed to see what dose of indigo carmine ingested orally mixed with~     the standard colonoscopy prep is needed to provide adequate staining of the right colon. It~     then will use this adequate staining concentration of Indigo Carmine to study whether this~     dye will increase the detection of polyps during colonoscopy.~   "
88301|NCT01901497|"~     The purpose of the study is to compare the pharmacokinetics of nebulized amikacin~     administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel~     ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are~     that the pharmacokinetics varies among the devices tested and that a most efficient device~     can be identified.~   "
88302|NCT01901484|"~     This study is about intestinal schistosomiasis, commonly known as bilharzia, in children~     aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni~     and the effects of the disease will be assessed.Children found positive with S. mansoni will~     be treated with praziquantel and followed up for a year.~   "
88303|NCT01901471|"~     The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced~     by tissue reperfusion. These reperfusion's injuries can be reduced by injection of~     cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final~     infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by~     cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock~     improves short-term and long term survival by reducing the size of the myocardial~     infarction. The hypothesis of this study is that the administration of Cyclosporin A to~     these patients, in addition to mechanical reperfusion, is likely to reduce the severity of~     the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.~   "
88304|NCT01901458|"~     The study will determine the advantage of the Spectra Optia® IDL set compared to the~     standard collection set for collection of peripheral blood progenitor cells using the~     Spectra Optia® apheresis system. The study will assess the reduction of apheresis time to~     obtain the required amount of hematopoietic progenitor cells.~   "
88305|NCT01901445|"~     The purpose of this study is to determine if the quality of life in children and adolescents~     diagnosed with chronic functional constipation improves after educational activity in focus~     group composed by these patients' mothers.~   "
88306|NCT01901432|"~     This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the~     safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in~     patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while~     Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or~     Part B and transition from one part to the other is not allowed.~      Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera~     according to the revised World Health Organization criteria. Only if the enrolment in Part A~     is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may~     be expanded to all patients with chronic myeloproliferative neoplasms.~      Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response~     will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e.~     at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study.~     All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess~     the clinico-haematological response.~      The study will last up to a maximum of 24 weeks of treatment. However, after completion of~     the trial, all patients achieving clinical benefit will be allowed to continue treatment~     with Givinostat (at the same dose and schedule) in a long-term study.~      Safety will be monitored at each visit throughout the entire duration of the study.~     Treatment will be administered on an outpatient basis and patients will be followed~     regularly with physical and laboratory tests, as specified in the protocol; in case of~     hospitalization, the treatment will be continued or interrupted according to the~     Investigators' decision.~   "
88307|NCT01901419|"~     Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin~     trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic~     inflammatory response, while insufficient and delayed neutralization of heparin by protamine~     may contribute to more blood loss during rewarming stage.~      Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment~     for unstable angina, myocardial infarction, congestive heart failure, and perioperative~     hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin~     infusion during rewarming corrects systemic ischemic stress and facilitates heparin~     neutralization in cardiac surgery.~   "
88411|NCT01900054|"~     The objective of this study is to evaluate the long-term safety and efficacy of TAU-284~     (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks~     administration.~   "
88310|NCT01901380|"~     Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an~     estimated incidence ranging between 2% and 3% in infants and marginally lower in older~     children. It has been demonstrated that it could be a risk factor for the development of the~     functional gastrointestinal disorders in children. Intestinal microflora has been indicated~     as potential target for the management of CMA and FGDIs through the use of probiotics.~     Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been~     demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following~     the addition of LGG, satisfying both the American Academy of Pediatrics guidelines.~     Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein~     formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved~     recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster~     induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and~     exerted at different levels: epithelium, immune system and enteric nervous system. Studies~     and meta-analyses showed that LGG increases treatment success in children with functional~     gastrointestinal disorders.~   "
88311|NCT01901367|"~     This randomized pilot phase II trial studies how well nutritional intervention and exercise~     intervention works in preventing metabolic syndrome in younger patients with acute~     lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of~     life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of~     being tired caused by cancer, may help improve strength, and may help build up lost muscle~     tissue. Nutritional intervention plus exercise intervention may be effective at preventing~     metabolic syndrome.~   "
88312|NCT01901354|"~     This study will compare two ventilator modes in mechanically ventilated patients with acute~     lung injury.~      Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able~     to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI.~     ALI causes 75,000 deaths in the US each year.~      Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet,~     pumps a small amount of air into the patient's lungs and then most of the air is released~     prior to the next breath. Another mode, called Airway pressure release ventilation (APRV),~     keeps air in the lungs longer between breaths. Both of these modes are currently used at~     this hospital. The investigators think APRV may help patients with ALI, but we do not know~     for sure.~   "
88313|NCT01901341|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the~     treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic~     non-cancer pain.~   "
88314|NCT01901328|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the~     treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic~     non-cancer pain.~   "
88315|NCT01901315|"~     The purpose of this project is to compare the effectiveness between face-to-face~     consultations and consultations via videoconferencing among patients treated in the~     Institute of Psychiatry (IPq).~   "
88316|NCT01901302|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the~     treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic~     non-cancer pain.~   "
88317|NCT01901289|"~     The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to~     provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting~     Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.~   "
88318|NCT01901276|"~     The colonic microbiome is essential in human health and disease. Clostridium~     difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused~     by antibiotics which perturb the microbiome and allow C. difficile to proliferate. Proton~     pump inhibitors (PPIs) are powerful suppressors of gastric acid and among the most common~     medicines in the United States. Dozens of observational studies show that longterm PPI use~     is associated with CDAD. However, the mechanism by which PPIs cause CDAD is unknown. We~     believe that PPIs cause CDAD by inducing alterations in the human colonic microbiome. We~     will confirm or refute the hypothesized mechanism for the association between PPIs and CDAD~     using an unblinded, single-armed study design. We will use pyrosequencing of the~     hypervariable V4 region of the bacterial 16S ribosomal subunit gene in human fecal samples~     to describe the colonic flora. We will collect fecal samples from volunteers before and~     after PPIs given for different durations and test the microbiome to determine 1) whether~     PPIs diminish overall diversity, 2) whether PPIs diminish relative abundance of~     Bacteroidetes, 3) whether increased duration of PPIs affects diversity, and 4) whether there~     is recovery of diversity after completing a defined course of PPIs. We believe that PPIs~     will cause a pattern of diminished overall microbiome diversity and reduced anaerobes — the~     same pattern seen after use of antibiotics. Furthermore, we believe that increased PPI~     duration will further diminish diversity and that the microbiome will return to pre-PPI~     levels of diversity after PPIs are stopped. These results will facilitate biologically-based~     clinical interventions to reduce rates of CDAD among patients who require acid suppression.~   "
88319|NCT01901263|"~     Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French~     National Alzheimer plan for the management of behavior problems of patients suffering from~     Alzheimer's disease or other related disorders and necessitating hospitalisation. This~     Alzheimer plan is promoting the evaluation of these units through the observation of the~     behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new,~     it appears important to assess their long-term impact on patients care.~   "
88320|NCT01901250|"~     The purposes of this study is to determine whether xylitol use in kindergarten school~     children in addition to oral health education, provision of tooth brush and fluoride paste,~     fluoride varnish and sealant treatment will reduce decay in the first permanent molars and~     other permanent teeth.~   "
88412|NCT01900041|"~     Pantovigar - a high effective product designed primarily for the treatment of diffuse hair~     loss in women as well as for the treatment of damaged hair, in the combined therapy can be~     successfully applied in other types of alopecia.~      The purpose of this study is to evaluate efficacy and tolerability of combination therapy~     Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined~     treatment Pantovigar plus 2% Minoxidil course therapy.~   "
88321|NCT01901237|"~     Adolescents and young adults who are living with cancer are not benefiting from the same~     age-appropriate physical and psychosocial care, as are children and older adults. As a~     result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a~     lack of age-appropriate care may be responsible for a deceased quality of life. Studies have~     also shown that physical activity is able to reduce many of the negative side-effects linked~     to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical~     activity that is both safe and manageable for cancer patients is yoga. The purpose of this~     study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha~     yoga program (available on DVD) in the adolescent and young adult non-curative cancer~     population. This study will also examine the ability of yoga to reduce cancer related side~     effects.~   "
88322|NCT01901224|"~     The investigators are doing this research study to find out if taking Metformin improves~     walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries~     (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle~     can hurt in patients with PAD and this is usually described as a cramp or tiredness. This~     pain is called intermittent claudication. Metformin is an FDA approved medication for the~     treatment of diabetes. The investigators believe that Metformin may help your leg muscles~     work better.~      The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at~     Brigham and Women's Hospital (BWH).~   "
88323|NCT01901211|"~     As children with cerebral palsy (CP) become teenagers, they experience a decrease in their~     physical function and mobility. Decreased mobility leads to increased social isolation for~     the teens and impacts negatively on their quality of life. This loss of function is~     multifactorial, but poor physical fitness and muscle weakness secondary to disuse are~     significant contributors. Exercise video games are a novel approach to engage youth in~     physical exercise and social interaction with their peers. The objective of this study is to~     evaluate the impact of an exercise video gaming intervention to improve physical fitness and~     social wellbeing. Our over-arching research questions are whether exergames can provide~     health benefits (improved physical fitness) and improved social wellbeing in youth with CP.~   "
88324|NCT01901198|"~     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of~     Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese~     healthy volunteers.~   "
88325|NCT01901185|"~     The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA)~     or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept~     (Enbrel®).~   "
88326|NCT01901172|"~     This multicenter, open-label study will evaluate the effect of posaconazole on the~     pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781~     formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with~     solid tumors.~   "
88327|NCT01901159|"~     This randomized, open-label, cross-over study will assess the bioavailability and safety of~     RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet~     and capsule) of the study drug under fed and fasting conditions.~   "
88328|NCT01901146|"~     The purpose of this research study is to compare the effectiveness and safety of ABP 980~     against trastuzumab in women with early breast cancer.~   "
88329|NCT01901133|"~     This study will assess the influence of hepatic impairment on the pharmacokinetics, safety~     and tolerability of a single dose of MDV3100 in male subjects.~      The study will consist of two treatment arms. Arm A will assess the influence of mild~     hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data~     obtained from subjects with hepatic impairment will be compared to data from Body Mass Index~     (BMI) and age-matched subjects with normal hepatic function.~   "
88330|NCT01901120|"~     This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name:~     mirabegron), and to determine the adherence to treatment with mirabegron.~   "
88331|NCT01901107|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of~     Kiklin® Capsules in actual clinical settings.~   "
88332|NCT01901094|"~     This randomized phase III trial studies axillary lymph node dissection to see how well it~     works compared to axillary radiation therapy in treating patients with node-positive breast~     cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may~     remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer.~     Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate~     whether radiation therapy is as effective as lymph node dissection.~   "
88333|NCT01901081|"~     This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to~     control an electromechanical prosthetic wrist and hand.~   "
88334|NCT01901068|"~     A great number of different suture techniques and suture materials are in use in order to~     reconstitute the abdominal wall integrity, but there is no surgical gold standard for~     abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials~     have been performed, which compared non-absorbable or long-term absorbable versus rapid~     absorbable suture materials or monofilament versus multifilament suture materials, or~     continuous versus interrupted suture techniques respectively. This lack of evidence has the~     following outcome: burst abdomen is observed in 1-3% of patients within the first days after~     a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated~     to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients~     undergoing a median laparotomy within the first 30 days. At present most surgeons favour~     monofilament long-absorbable continuous sutures as the most suitable material for closing~     abdominal wounds after midline laparotomy.~   "
88335|NCT01901055|"~     Diabetes self-management is important to help adults with type 2 diabetes achieve glucose~     control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a~     barrier to diabetes self-management and glucose control. We will examine if treatment of~     obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with~     diabetes education, results in improved diabetes self-management and glucose control.~   "
88472|NCT01899261|"~     This pilot clinical trial studies stereotactic body radiation therapy in treating patients~     with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be~     able to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
88336|NCT01901042|"~     Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether~     the use of symbiotic would prevent early symptoms of radiation proctitis and improve the~     quality of life in patients undergoing radiotherapy for prostate cancer treatment. We~     randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of~     dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming~     units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They~     were instructed to dilute one sachet in 200mL of water and drink once a day during the week~     before the beginning of radiotherapy sessions, and increase the dose to two sachets daily~     after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC~     QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.~   "
88337|NCT01901029|"~     To determine the prevalence of sexual problems particularly premature ejaculation and~     erectile dysfunction among men working in factories of Dongguan city, using the self-rating~     scales like International Index of Erectile Function, and to investigate the characteristics~     or risk factors associated with these sexual problems in floating population through~     regression analysis.~   "
88338|NCT01901016|"~     Prevalence of depression is higher in people living with human immunodeficiency virus~     (PLHIV) than among seronegative people. Depressive symptoms have been observed in up to 40%~     of seropositive population. Presence of depressive symptoms has a negative impact on quality~     of life, optimal compliance of antiretroviral treatment, adoption of safe sexual behaviors,~     and on immune status and viral load.~      Although antidepressants and psychotherapeutic interventions -particularly those with~     cognitive-behavioral components— have been proven effective in decreasing depressive~     symptoms in PLHIV, their use is limited among other causes due to misdiagnosis, patient~     refusal, possible interaction with antiretroviral treatments, or unavailability in the case~     of psychotherapy. Furthermore, identification and assessment of more accessible~     interventions that would decrease depressive symptoms and improve quality of life in PLHIV~     has become a crucial objective in the management of this chronic disease.~      A meta-analysis shows that relaxation is an efficient intervention to reduce depressive~     symptoms in people diagnosed with depression or with high levels of depressive symptoms.~     According to some authors, relaxation, an easy-to-learn and self-applied intervention,~     proves to be a simple first line therapy capable of reducing depressive symptoms. However,~     the amount of relaxation needed to produce an effect on depression was not established in~     this meta-analysis and there are no results on the effects of relaxation in people whose~     depressive symptoms were caused by other diseases and only a study which includes PLHIV.~      Given the prevalence of depressive symptoms and its consequences on the health of PLHIV and~     given the effects of relaxation on depressive symptoms, this pilot project aims to evaluate~     feasibility and acceptability of a relaxation intervention in PLHIV who suffer depressive~     symptoms, assess the feasibility and acceptability of the research project and assess the~     preliminary effects of a relaxation intervention.~   "
88339|NCT01901003|"~     Seven French university hospitals will participate in this multicentric prospective, blinded~     and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo~     (microcrystalline celluloses) and no premedication at all. The third group (no~     premedication) is necessary in order to evaluate a placebo response, which may be~     significant on anxiety level and patients perceptions of care. It was calculated that 969~     patients had to be included in order to obtain a 5 point difference between groups on the~     EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an~     estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective~     surgery under general anesthesia can be included after information by an anesthesiologist in~     charge of the study and written informed consent. Non inclusion criterions are: a weight~     below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive~     functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug~     addiction or former cognitive disease. The technique of anesthesia will be decided by the~     attending anesthesiologist, who will be unaware of the premedication technique,~     independently of the study protocol.~   "
88340|NCT01900990|"~     The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy~     patients innovatively. The investigators randomly allocate the subjects into two groups. One~     group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive~     Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.~   "
88341|NCT01900977|"~     PopART is a community randomized trial that is investigating whether a community-wide~     combination HIV prevention package including annual home-based HIV testing, active referral~     and the offer of immediate ART for those testing HIV-positive, along with the promotion of~     proven HIV prevention methods (such as voluntary medical male circumcision, prevention of~     mother to child transmission and condom use), will help to prevent transmission and~     substantially reduce new HIV infections. The study is being conducted in 21 communities in~     Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total~     population of approximately 1.2 million individuals.~   "
88342|NCT01900964|"~     A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane~     when used for a post-extraction ridge preservation procedure to prevent the bone loss that~     typically occurs. The hypothesis is that there will be no difference in the clinical and~     histologic results between the two membranes.~   "
88343|NCT01900951|"~     Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with~     chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide~     following 4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC.~   "
88344|NCT01900938|"~     The aim of this study is to compare sedation efficiency, safety and satisfaction by both~     endoscopist, assistants, and the patients between continuous infusion and intermittent bolus~     injection of propofol for deep sedation during ERCP.~   "
88345|NCT01900925|"~     There will be two groups of patients with low back pain (by randomization). Both groups will~     receive a pragmatic treatment approach by physical therapists for low back pain. One group~     will also receive a prescriptive treatment approach for both hips. The investigators feel~     that the additional of a standardized exercise program and stretching for the hips will~     improve outcomes in patients with mechanical low back pain.~   "
88413|NCT01900028|"~     This is a 3-part study in patients with advanced solid tumours: Part A will assess the~     effect of itraconazole on the PK parameters of olaparib and will determine the effect of~     olaparib on the QT interval following single oral dosing; Part B will determine the effect~     of olaparib on the QT Interval following multiple oral dosing; Part C will allow patients~     continued access to olaparib after the PK and QT phases and will provide for additional~     safety data collection. A total of 48 patients are planned to be enrolled; at least 42~     evaluable patients will be required to complete the study. Patients will participate as a~     single cohort in all parts of the study.~   "
88473|NCT01899248|"~     The purpose of this study is to assess the effects of inhalation agent on corrected QT~     interval duration during liver transplantation.~   "
88346|NCT01900912|"~     Behavioral change is a key ingredient for successful adoption of better sanitation practices~     in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise~     awareness and emphasize the benefits of toilet usage. These endeavors, often combined with~     subsidies linked to toilet construction by households, seek to create a demand for~     sanitation goods. Yet, progress in securing the desired outcomes from sanitation programs~     has been slow. Moreover, benefits of sanitation largely take the form of externalities,~     which individuals do not take into account when making their own decisions about~     investments. This makes sanitation promotion at the household level particularly~     challenging.~      A new approach to sanitation entails a shift away from the provision of subsidies for~     toilets to individual households and a promotion of behavioral change at individual-level~     towards emphasizing collective decision-making in order to produce 'open defecation-free'~     villages. The objective of the intervention is to reduce the incidence of diseases related~     to poor sanitation and manage public risks posed by the failure to safely confine the~     excreta of some community members. The way to achieve this objective is by empowering~     communities motivated to take collective action. Local governments and other agencies~     perform a facilitating role. There is a growing recognition that this approach, referred to~     as Community-Led Total Sanitation (CLTS), may help with the reduction of open defecation~     practices. However, no rigorous impact evaluation of CLTS has been conducted so far. This~     randomized controlled trial will study the effect of CLTS in rural Mali. As a result, sound~     evidence will become available to see to what extent CLTS improves health outcomes and what~     is driving collective action in order to increase sanitation coverage.~      The direct recipients of the intervention are members of rural communities in Mali who~     aspire to live in a cleaner environment. The donor community, international organizations,~     and governments in developing countries will benefit from having simple and clear evidence~     on the effectiveness of an innovative program for improving sanitation in rural areas. They~     will learn whether the program has worked or failed to achieve its objective of eradicating~     open defecation, and about key factors explaining success and failure.~   "
88347|NCT01900899|"~     The purpose of this study is to evaluate the long-term antibody persistence as well as~     safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster~     vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039~     Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039~     (NCT00474266) at 12 through 23 months of age.~   "
88348|NCT01900886|"~     Primary objective: Evaluate the prevalence of personality disorders in patients starting~     treatment for hepatitis C in the prison and determine their influence on the evolution of~     the disease.~   "
88349|NCT01900873|"~     Patients with chronic obstructive pulmonary disease are often limited in their exercise~     capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung~     volumes during exercise which forces inspiratory muscles to work at a high percentage of~     their maximal capacity. This increased inspiratory effort has been shown to be independently~     related to symptoms of dyspnea during exercise in previous research. Eight weeks of high~     intensity variable flow resistive inspiratory muscle training is hypothesized to reduce~     inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are~     hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of~     dyspnea and to improve exercise tolerance in these patients.~   "
88350|NCT01900860|"~     We propose to conduct a randomized double blind trial of three doses of vitamin D, 400,~     4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and~     architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT)~     measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA).~     Other measures of bone and calcium metabolism will be assessed. The trial will last as long~     as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be~     recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome~     variables assessed include quality of life, depression, muscle strength and balance.~   "
88351|NCT01900847|"~     Our goal is to study whether giving people low dose ketamine along with morphine when they~     come to the Emergency Department will help their pain more than giving morphine by itself.~     There have been many studies showing that low dose ketamine is safe and effective for pain~     control. Ketamine is frequently used for pain control in ambulances and helicopters~     transporting injured patients to the hospital and has also been used for pain control in~     people who have just had surgery. The investigators would like to see if low dose ketamine~     would be safe and effective for patients with pain in the Emergency Department.~      Patients are eligible for the study if they come to the Emergency Department and their~     treating physician decides to treat them with morphine (with certain exceptions such as~     pregnant patients and patients with eye injuries). They will be given information about~     participating in the study and if they agree, they will be given the study drug. The study~     drug will be either ketamine or salt water (saline). If patients continue to be in pain they~     will continue to receive doses of morphine just as they would if they were not in the study.~     If the treating physician feels that morphine alone is not enough, they will be free to~     choose another pain medication as they would normally.~   "
88352|NCT01900834|"~     This study is conducted in the United States of America (USA). The aim of this study is to~     assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D),~     type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.~   "
88353|NCT01900821|"~     The National Mammography Database (NMD) leverages data that radiology practices are already~     collecting under federal mandate by providing them with comparative information for national~     and regional benchmarking. Participants receive semi-annual feedback reports that include~     important benchmark data such as cancer detection rates, positive predictive value rates and~     recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence~     (BICOE) facilities.~   "
88354|NCT01900808|"~     Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but~     fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%.~     The aim of this study is to evaluate the applicability and diagnostic accuracy of TE~     performed by trained operators (<500 explorations), after a second evaluation by experienced~     explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM~     will be re-evaluated by experienced operators with the M (standard size) probe. A third~     register will be performed with XL (obese size) probe in those patients with inadequate M~     probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to~     identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).~   "
88355|NCT01900795|"~     The primary objective of this study is to assess the analgesic properties of an oral dose of~     V117957 4.5 mg aqueous suspension in the third molar extraction model~   "
88356|NCT01900782|"~     This withdrawn study was to assess the safety and efficacy of secukinumab compared to~     etanercept and placebo in patients who have moderate to severe, chronic, plaque-type~     psoriasis.~   "
88357|NCT01900769|"~     Although blood volume is such an important parameter in everyday clinical medicine it cannot~     be measured easily. As a matter of fact, it is almost never measured but estimated or~     calculated based upon numbers derived from mostly healthy patients.~      The investigators do not even know whether someone's normal - i.e. before a surgery - blood~     volume is actually anywhere close to the generally accepted estimate or calculation.~      Tests exist in which a substance of known concentration is diluted in a person's blood~     volume and the resulting concentration is then measured, which allows the blood volume to be~     calculated. However, none of these tests can be completed at the bedside since they are not~     fast and require considerable set-up.~      This study turns the above approach upside-down: we will dilute the blood slightly with a~     known small volume of an intravenous fluid commonly used in many clinical settings and~     measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells -~     before and after adding the fluid. That allows for similar calculations without using~     neither specialized substances nor equipment.~      Hemoglobin is routinely measured in laboratories and is often a routine test before and~     during surg-eries and in intensive care units.~      Devices that can measure hemoglobin through the skin without actually drawing any blood are~     avail-able. If found comparable to laboratory determination of hemoglobin they could provide~     for a bedside and almost real-time assessment of blood volume, something that could be~     extremely valuable for de-cision making in critical areas of medicine and promoting goal~     directed therapies.~   "
88358|NCT01900756|"~     The purpose of this study is to determine whether a culturally-sensitive multipronged~     post-discharge intervention can significantly reduce blood pressure, enhance achievement of~     guideline recommended targets for risk factor control, and lower recurrent vascular events~     in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase~     (Phase 1) lasting less than one year involving development of the intervention through focus~     group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3~     years involving a randomized trial testing the efficacy of the intervention.~   "
88359|NCT01900743|"~     This is an international (France, Austria and Germany), randomized, double-blind,~     placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in~     patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS)~     after failure or intolerance to doxorubicin (or other anthracycline).~      Five cohorts will be defined:~      Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other~     sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas~     listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet~     the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment~     groups.~   "
88360|NCT01900730|"~     The goal of this clinical research study is to learn if receiving valproic acid (VPA)~     compared to a placebo can reduce the amount of time you will need to have an indwelling~     pleural catheter compared to the standard of care, which involves using an indwelling~     pleural catheter alone.~      VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer~     cells to become less malignant and cause less pleural fluid production.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
88361|NCT01900717|"~     To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly~     patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm~     with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years~     and older.~      This study is destined to continue as a phase III trial if both arms meet the selection~     criteria to show or not the benefits of treatment with bevacizumab combined with~     chemotherapy.~   "
88362|NCT01900704|"~     To investigate the efficacy and safety of SER120 nasal spray formulations in patients with~     nocturia~   "
88363|NCT01900691|"~     The CLARITY study is a clinical trial approved by US FDA to study the removal of the~     Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.~   "
88364|NCT01900678|"~     The objective of this investigation is to evaluate whether pulmonary vein isolation using~     the VytronUS ablation system is safe and effective acutely and at 3 months.~   "
88365|NCT01900665|"~     To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease~     (AD) as compared with placebo in participants with mild AD.~   "
88366|NCT01900652|"~     The primary purpose of this study is to evaluate the efficacy of the study drug known as~     LY2875358, administered alone or in combination with a second drug named Erlotinib, in~     participants affected by a defined type of lung cancer (MET biomarker diagnostic positive~     Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent~     treatment with Erlotinib.~   "
88367|NCT01900639|"~     Low-dose aspirin is a cornerstone in the secondary prevention of cardiovascular disease~     (CVD) and is usually taken on awakening, although evidence regarding optimal time of intake~     is lacking. Platelet reactivity follows a circadian rhythm, with a peak in the morning,~     contributing to the morning peak of cardiovascular disease. Due to its short half life,~     aspirin only inhibits platelets which are present at the time of intake. Thus, the timing of~     aspirin intake may influence its inhibitory effect on platelets and intake of aspirin at~     bedtime may attenuate the morning peak of platelet reactivity. The time-dependent effect of~     aspirin on circadian rhythm of platelet function has never been studied before. We~     hypothesize that aspirin intake at bedtime compared with intake on awakening results in a~     reduction of the morning peak in platelet reactivity.~   "
88368|NCT01900626|"~     This is a study comparing pain control utlilizing one or two epidural catheters, along with~     a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.~   "
88424|NCT01899885|"~     The objective of this study is to implement an optimized perioperative course for patients~     undergoing acute high-risk abdominal surgery in order to improve the outcome.~      The optimized perioperative course consists of a number of interventions carried out before,~     during and after surgery.~   "
88425|NCT01899872|"~     The aim of this study is to evaluate the effect of a single session of aerobic plus~     resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The~     investigators hypothesize that a single aerobic exercise session would promote greater~     benefit in vascular function of patients with type 1 diabetes, as compared with the~     resistive exercise session.~   "
88369|NCT01900613|"~     Obesity and overweight are health problems resulting from the interaction of predisposing~     genes with environmental, economic and social stimuli, in conjunction with excess caloric~     intake throughout growth from childhood to adulthood. (Haworth, Plomin et al. 2008; Sinha~     and Kling 2009). Evidence suggests that a major barrier in controlling overweight/obesity is~     the complex interrelation of these factors, making single-approach interventions less likely~     to succeed than integrated, multi-faceted approaches (Dobbins, De Corby et al. 2009). The~     proposed project aims to deliver a multi-faceted behavioral intervention developed over the~     past 18 months by a university-community /school-based collaborative. This project aims to~     provide new knowledge about the effectiveness of interventions designed specifically to~     achieve successful weight management among Mexican-origin children ages 3-8, and identify~     associated mediating factors. Deliverables will include community-based, collaborative and~     sustainable tools to support weight-management goals in this demographic. UC Davis and UC~     Cooperative Extension (UCCE) faculty form the investigator team, collaborating on key~     decision points with the project community in California's Central Valley. The investigators~     hypothesize that the identified mediating factors will increase fruit and vegetable~     consumption. The investigators also hypothesize an increase in the intensity and frequency~     of physical activity among children in the intervention group.~   "
88370|NCT01900600|"~     The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind,~     placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the~     prevention of recurrent cardiovascular events among stable post-myocardial infarction~     patients with elevated high sensitivity C-reaction protein (hsCRP) [CACZ885M2301]).~      The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively~     measure changes in aerobic exercise capacity in patients with prior myocardial infarction~     (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced~     systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to~     Canakinumab (3 different doses) or Placebo.~      The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over~     the first 12 months of the CANTOS trial. The subjects will received the experimental~     treatment as randomized in the main CANTOS trial and they will not receive any additional~     experimental treatment as part of the sub-study.~      This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth~     University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.~   "
88371|NCT01900587|"~     The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER)~     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release~     formulation 2 (PR2) tablet, in healthy participants.~   "
88372|NCT01900574|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     study medication) and safety of subcutaneously (under the skin) administered golimumab in~     pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative~     Colitis (UC).~   "
88373|NCT01900561|"~     This study will provide much needed information about how to optimize the quality of care~     and quality of life of Veterans who are survivors of prostate cancer.~   "
88374|NCT01900548|"~     The aim of this study is to investigate potential metabolic effects of whey protein high in~     protein and high in leucine(HPHL) compared to soy protein high in protein and low in~     leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.~      The investigator hypothesize that HPHL will increase physical function and the ratio muscle~     mass / fat mass in this condition.~   "
88375|NCT01900535|"~     The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison~     with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.~   "
88376|NCT01900522|"~     The purpose of this study is to characterize the safety and tolerability profile of ITI-214~     when administered as multiple doses of oral solution at escalating dose levels.~   "
88377|NCT01900509|"~     Participants with relapsed or refractory leukemia or lymphoma will be recruited for this~     study to find whether or not the addition of a new drug called bendamustine will be safe and~     possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug~     Administration (FDA) for the treatment of other cancers in adults that are similar to those~     being studied in the research trial.~      PRIMARY OBJECTIVES~        -  To establish the maximum tolerated dose (MTD) of bendamustine in combination with~          clofarabine and etoposide in pediatric participants with hematologic malignancies.~        -  To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine~          in combination with clofarabine and etoposide.~      SECONDARY OBJECTIVES~        -  To estimate event-free survival at 4 months.~        -  To estimate minimal residual disease (MRD) levels present at end of each cycle of~          therapy in participants with leukemia.~        -  To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.~   "
88378|NCT01900496|"~     This research is being done to study a combination of Brentuximab vedotin and Rituximab for~     the treatment of relapsed Hodgkin's Lymphoma (HL).~   "
88379|NCT01900483|"~     The project will specifically focus on the examination of the influence of substantial~     weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial~     weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of~     reward and inhibitory networks in diabetic subjects. Therefore the investigators will~     conduct a functional magnetic resonance imaging (fMRI) study investigating functional~     measures.~   "
88380|NCT01900470|"~     The purpose of this proposal is to compare the effectiveness of community health worker~     (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to~     improve control of chronic conditions. Upon enrollment each patient will select one of their~     multiple chronic conditions as a focus for the trial and work with his/her PCP to set a~     chronic disease management goal. Patients are then randomized to receive usual primary care~     vs. CHW support for moving towards that goal.~   "
88426|NCT01899859|"~     The primary objective of this study is to characterize the safety, tolerability and~     dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects~     with biopsy-proven NASH with advanced liver fibrosis.~   "
88474|NCT01899235|"~     A randomised open-label pilot study to assess the safety and efficacy of treatment with a~     drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to~     coronary de novo lesions in vessels 2.5 mm - 4.0 mm.~   "
88381|NCT01900457|"~     The present project aims at describing how vestibular signals contribute to the multisensory~     mechanisms of bodily self-consciousness.~      There is a large body of data regarding the sensory and neural mechanisms of~     self-consciousness, but most studies have so far demonstrated the contribution of visual,~     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have~     neglected the contribution of the vestibular system, a major sensory system for spatial and~     bodily representations. The vestibular system is sensitive to head motions in space and head~     inclinations with respect to gravity and it should therefore contribute significantly to~     several bodily experiences. This contribution should be put under neuroscientific scrutiny.~     We believe that the current neuroscientific models of bodily self-consciousness will be~     incomplete until they incorporate the contribution of vestibular signals.~      The present project specifically aims at testing the hypothesis according to which~     vestibular signals significantly influence bodily self-consciousness, in particular~     first-person and third-person perspective taking and the internal body models (i.e. the body~     schema and body image). The present project also aims at describing how cortical vestibular~     processing is modified during experimental changes of perspective taking and viewpoint. In~     addition, the present project will describe whether vestibular disorders change performances~     in third-person perspective taking tasks and modify internal body models. This should help~     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine~     approaches from psychophysics and electrophysiology (electromyography,~     electroencephalography) in healthy volunteers and behavioral approached in patients with~     vestibular disorders.~      These studies should further the understanding of how the brain processes vestibular~     signals, which is to date poorly understood. In addition, the outcome of the present project~     should help understanding the multiple and complex symptoms reported by patients with~     vestibular diseases, and should therefore improve their treatment.~   "
88382|NCT01900444|"~     The aim of this study is to document the immunogenicity and safety of a booster dose of~     IMOJEV® administered 12 months after the primary dose.~      Primary objective:~        -  To describe the immune response to Japanese Encephalitis (JE) before (Day 0) and 28~          days (Day 28) after a booster dose of IMOJEV® administered at least 1 year after~          primary vaccination with IMOJEV®.~      Exploratory objectives:~        -  To test the non-inferiority of IMOJEV® versus previous data obtained in the JEC15 study~          (NCT01190228) with the same product in terms of seroprotection rate 28 days after~          booster vaccination.~        -  To describe the safety profile of a booster dose of IMOJEV® .~   "
88383|NCT01900431|"~     Primary Objective:~      To evaluate the efficacy of sarilumab at week 16 in patients with non-infectious uveitis~     (NIU).~      Secondary Objectives:~      To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of~     subcutaneous sarilumab in patients with NIU. To evaluate the change in macular edema. To~     evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal~     vessel leakage. To evaluate the effect of sarilumab on reducing concomitant~     immunosuppressant therapy.~      To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the~     pharmacokinetics of sarilumab in NIU patients. To evaluate the immunogenicity with anti-drug~     antibodies (ADA).~   "
88384|NCT01900418|"~     For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors,~     aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong~     disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness~     (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an~     evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease~     (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them~     maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness,~     and 3) thereby enable them to remain on AI therapy as prescribed.~   "
88385|NCT01900405|"~     This study has the objective to determine if intranasal dexmedetomidine, a sedative, is~     suitable for pediatric sedation in children undergoing tomographic scans.~   "
88386|NCT01900392|"~     This study aims to evaluate the effectiveness of financial incentives in improving and~     maintaining weight loss.~   "
88387|NCT01900379|"~     The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome~     (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG)~     surgery or other coronary reperfusion.~   "
88388|NCT01900366|"~     This study will test the potential of two techniques using light properties of adipose~     tissue to diagnose crown-like structures and inflammation to be compared with pathologic~     examination of adipose tissue biopsies from ongoing clinical studies.~   "
88389|NCT01900353|"~     The aim of this randomized, single-blind, split-mouth design, clinical trial was to evaluate~     the effectiveness in plaque removal of the vertical and the horizontal brushing methods.~     Trauma on soft tissues were also registered. Sixty-one (61) young adults were enrolled for~     this trial and forty-three (43) completed the brushing session. All subject were asked to~     abstain from oral hygiene procedures for 48 hours before the brushing session to allow~     adequate plaque accumulation. They were firstly instructed to use a dental disclosing tablet~     in order to easily permit to detect dental plaque on teeth and to highlight soft tissue~     abrasions. Plaque and the abrasion indexes were recorded according to the Rustogi Modified~     Navy Plaque Index (RMNPI) and the Danser Index (DI) by the same examiner. The brushing~     session was always performed by the same dental hygienist who brush with a randomized~     split-mouth design. After the brushing session, the blinded examiner recorded the indexes~     again.~   "
88390|NCT01900340|"~     The aim is to further establish a physiological role for GLP-1 as an endogenous satiety~     signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on~     appetite and food intake in healthy male subjects.~   "
88391|NCT01900327|"~     Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary~     Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma~   "
88392|NCT01900314|"~     The purpose of this research is to learn more about how rTMS works to reduce the symptoms of~     depression. This information can be used to improve the effectiveness of the treatment. The~     study will use functional magnetic resonance imaging (fMRI) to examine changes in brain~     function after treatment with rTMS. fMRI is a safe and painless technique that allows~     investigators to observe the brain at work. The investigators will use fMRI to see what~     regions of the brain become active when you perform a concentration task and how that~     activation is changed after rTMS.~   "
88456|NCT01899469|"~     Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or~     Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.~      Design: Single-blind experimental prospective study of clinic intervention. Setting:~     Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.~      Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were~     divided into three randomized groups: Back School (group 1), TENS with Back School (group~     2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of~     treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were~     measured, at the beginning and at the end of the treatment and after three and six months.~     Anthropometric and physical activity variables were collected.~   "
88393|NCT01900301|"~     Fear, whether it occurs in humans suffering from an anxiety disorder or in experimental~     models with rodents, is reduced by exposing the frightened organism to the fearful stimulus~     in the absence of any negative consequences (i.e., extinction, or exposure therapy).~     However, fear often renews when the feared stimulus is encountered in a context different~     from the exposure context. In rats, the investigators found that interfering with the~     animal's ability to process contexts during extinction by administering an anticholinergic~     drug prevented fear renewal. This proposal will determine if the beneficial effect of this~     drug translates to exposure therapy in socially anxious humans. To this end, 100 individuals~     with Social Phobia who fear public speaking will undergo repeated sessions of exposure to~     public speaking, within a virtual reality context. Participants will be randomized to either~     drug placebo, .2mg/.01 mL Scopolamine, .3mg/.01 mL Scopolamine or .4mg/.01 mL Scopolamine,~     administered via nasal drops, prior to each session of exposure therapy. One month after~     completion of exposure therapy, context renewal will be tested by comparing physiological~     and subjective responses to public speaking in the same virtual context as used during~     exposure therapy versus a context different than the one used during exposure therapy. The~     goal is to identify the dose of Scopolamine associated with the greatest reduction in~     context renewal. In addition, a secondary analysis will attempt to identify those~     individuals who benefit most from Scopolamine-augmentation of exposure therapy.~   "
88394|NCT01900288|"~     The purpose of this study is to test Mobile Technologies in Assisting Patients & Family~     Caregivers in Healthy Living and complex home care by connecting to information and~     professionals from a distance.~   "
88395|NCT01900275|"~     Across the world, the most common cause of dying in the ICU is a disease called sepsis.~     Sepsis is a disease in which the body's protective response to infection becomes too~     intense, unnecessarily damaging important organs in the body. Kidney damage during sepsis is~     particularly bad, as a person's chance of survival drops significantly when he or she~     develops kidney failure. This study plans to learn more about how to detect (and thus~     prevent) kidney failure early in sepsis. The current tests doctors use only detect kidney~     failure once it's already happened. We must therefore find better ways of detecting kidney~     failure earlier, when there is still a chance to protect the kidneys.~      In this study, patients will provide a one-time sample of urine. We will check this urine~     for signs of a protein called heparanase, which we believe is important in early kidney~     failure. We will then see if high heparanase activity in urine predicts the risk of~     developing kidney failure. We will compare results from patients with sepsis with results~     from patients with trauma, allowing us to determine if heparanase is only important in~     sepsis kidney failure.~   "
88396|NCT01900262|"~     The purpose of this study is to understand the effects of muscle strengthening and balance~     exercise interventions on muscle strength, running mechanics and postural control in novice~     recreational runners. Participants will be assessed before and after they engage in an~     8-week exercise intervention program.~   "
88397|NCT01900249|"~     The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions~     are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.~   "
88398|NCT01900236|"~     iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic~     patients during the first year of HIV care on a flexible delivery schedule, with~     intervention visits scheduled to coincide with HIV medical care visits. Interventionists~     from each participating collaborating site will be trained centrally to implement the~     iENGAGE protocol. Following study enrollment and baseline assessment, participants will be~     randomized to treatment as usual and intervention groups. For intervention-arm participants,~     each iENGAGE intervention session includes: interventionist-delivered educational content~     for managing HIV medical care appointment-keeping and information sessions for learning to~     manage HIV medications. The intervention will have a tailored, interactive agenda for each~     of the 4 sessions based on behavioral motivational interviewing (MI) techniques. The goal of~     this intervention is for the participant to establish early behaviors that help him/her to~     arrive at scheduled medical appointments and learn to take medications as prescribed during~     the initial year of HIV care in order to improve overall health.~   "
88399|NCT01900223|"~     Chronic pain is relatively common after different types of surgery. The investigators intend~     to study prevalence, characteristics and risk factors of chronic pain after shoulder~     arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as~     preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.~   "
88400|NCT01900210|"~     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR) Project is~     to develop and test an intervention designed to increase positive decision-making skills~     among offenders for healthy living, including skills for making decisions for reducing~     disease risk behaviors, particularly those involving HIV and Hepatitis B & C. This project~     focuses on the critical transition time between incarceration and return to the community.~   "
88401|NCT01900197|"~     The purpose of this study is to monitor and quality assure the efficacy and safety of~     Monofer® in a broad patient population when Monofer® is used according to the Monofer® label~     (SPC) in current practice and where standard routines are being followed.~   "
88402|NCT01900184|"~     1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending~     single/multiple oral doses (SAD & MAD) in healthy young subjects, the preliminary food~     interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine~     pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic~     preliminary profiles of QGC001 and its metabolite EC33 especially effects on the~     renin-angiotensin-aldosterone and copeptin systems.~   "
88403|NCT01900171|"~     QGC001/1QG1 is a Phase I first time in man study aiming to determine the overall safety~     and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared~     to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the~     pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system,~     blood pressure and heart rate) in healthy male subjects.~   "
88404|NCT01900158|"~     This is a Phase I/II Dose Escalation Study in which the safety, tolerability and efficacy of~     Amphinex-induced Photochemical Internalisation (PCI) of Gemcitabine followed by~     Gemcitabine/Cisplatin Chemotherapy will be assessed in patients With advanced inoperable~     cholangiocarcinomas.~   "
88475|NCT01899222|"~     Assessment of handheld fundus images in comparison to conventional fundus camera images.~   "
88405|NCT01900132|"~     Background:~      - Electrical impedance myography (EIM) is a new technique being studied to see if it is~     helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild,~     painless electrical current travels through muscles. Researchers want to gain experience in~     using the EIM device. They will collect information on the results of using it on people~     with and without nerve and muscle diseases, and compare that with information from other~     standard tests. First, they will test the device on healthy people. Then they will test~     people with a variety of neuromuscular diseases. Because the test is noninvasive and not~     painful, researchers will test both children and adults.~      Objectives:~      - To gain experience using the EIM muscle testing device.~      Eligibility:~        -  Healthy volunteers at least 2 years old.~        -  Individuals at least 2 years old who have neuromuscular disease.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have one 2 3 hour clinic visit. Researchers may request follow-up~          visits.~        -  Participants will be tested with the EIM device. The device and small electrodes will~          be placed on their skin. An electric current will pass through the device, but the~          participants will not feel this.~        -  Participants may have an ultrasound test. A gel will be put on their skin, and a device~          will be moved over the skin.~        -  Participants may have a nerve test. Electrodes will be placed on their skin, and they~          will feel a small shock.~        -  Participants may have a test where a thin needle is inserted in their muscle.~   "
88406|NCT01900119|"~     Background:~      - This research is being done to describe the types of bacteria found in the mouths of~     patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the~     immune system or with stem cell transplant. People with SAA who receive these treatments are~     more likely to get infections. Studies show that there might be a link between the bacteria~     in your mouth and those bacteria that can cause infections. The bacteria found in the mouths~     of patients with SAA will be described.~      Objectives:~      - To understand the changes in mouth bacteria that are related to treatment and to describe~     the oral bacterial environment.~      Eligibility:~        -  Adults at least 18 years of age who are going to be treated for SAA.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will answer questions about their medical history and dental care. Their~          mouths will be examined.~        -  Participants with SAA will be tested during treatment for their disease, over the~          course of 1 year. All participants with SAA will be tested at 3 scheduled appointments.~          Any participants who require a breathing tube will receive additional tests.~        -  Healthy volunteers will be tested during 1 visit.~        -  Participants will give two samples each time. A saliva sample will be taken with a~          disposable padded tool. Skin cells will be collected from the tongue with a small~          plastic brush.~   "
88407|NCT01900106|"~     1. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to~     compare the 48-weeks virological response of two different regimens containing~     abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine~     + raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care~     with CD4+ counts < 200/mm3.~      1.1 Clinical Objectives: Primary Objective: To compare the 48-week virological response to~     two different regimens containing abacavir/lamivudine (abacavir/lamivudine~     +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral~     therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3.~      Secondary Objective: a) To compare immunological response at 48 weeks; b) To determine the~     safety and tolerability of the 2 regimens.~      1.2 Study population: 350 in/out patients 1.3 Outcome Primary Endpoint~        -  Proportion of patients with HIV RNA<50 copies/mL after 48 weeks Secondary Endpoints(s)~        -  Change in CD4+ cell count from baseline through week 48~        -  Time to virological rebound 1.4 Study design: Multicentre, parallel group, randomised,~          open label, non-inferiority study 1.5 Treatment regimens: Arm A: abacavir/lamivudine 1~          tablet once a day + raltegravir 400 mg (1 tablet twice a day) Arm B:~          abacavir/lamivudine 1 tablet once a day + ritonavir 100 mg + darunavir 800 mg once a~          day.~      All drugs have been approved for the treatment of HIV infection. The study population will~     consist of 350 HIV-positive, HLA B5701-negative patients. At baseline, patients will be~     randomized 1:1 to start abacavir/lamivudine plus either raltegravir or darunavir/ritonavir.~     Randomization will be stratified on the basis of the screening CD4+ cell count (≤100 vs ≥100~     cells/µL), to ensure balance across treatments groups 1.7 Criteria for Safety: Adverse~     events and laboratory assessments. 1.8 Statistical analysis: As this is a non-inferiority~     trial, we will calculate the difference in the proportions of patients experiencing the~     primary outcome in the two treatment arms and will calculate a 95% confidence interval for~     this. Non-inferiority of the raltegravir arm will be demonstrated if the lower limit of the~     95% confidence interval is greater than -12%. In case non-inferiority will be met, analyses~     for superiority will be performed.~   "
88408|NCT01900093|"~     Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not~     widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to~     evaluate the response to ACTHAR gel therapy in patients who have failed to make a~     satisfactory recovery after treatment with high dose IVMP. Documentation of the clinical~     course as well as any adverse events related to IVMP use will be made. The investigators~     propose to study the potential benefit of a 14-day course (the dose historically used since~     the landmark clinical trial of Rose et al1) of subcutaneous ACTHAR gel in 10 patients who~     have demonstrated inadequate improvement after a course of IVMP, 1000 mg daily, for 5~     treatments (over a maximum of 8 days). These would be patients for whom PLEX would be~     considered as a treatment possibility. The primary outcome measure will be improvement in~     the targeted neurological deficit, as measured on the appropriate functional system score~     (FSS) of the EDSS.~   "
88409|NCT01900080|"~     The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy~     (ART) initiation improves retention in care (as measured by the proportion of participants~     who are alive and in-care with an undetectable viral load 12 months after HIV testing),~     compared with standard of care (three visits prior to ART initiation). Secondary outcomes~     include survival, ART initiation, retention in care with viral load < 200 and < 1000~     copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill~     records. Enrollment for the main study was completed in October 2015.~      In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC~     AIDS, includes patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3. The~     purpose of the sub-study is to compare 6-month retention for patients who receive same-day~     ART vs. standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and~     cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing.~   "
88410|NCT01900067|"~     The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled~     Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active~     Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia~     Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is~     no difference between the two study populations (interventional treatment group versus~     control treatment group) regarding the average of core body temperature measurements during~     the perioperative phase.Alternative hypothesis (H1): The average of core body temperature~     measurements during the perioperative phase is significantly higher in the interventional~     group compared to that of the control group.~   "
88414|NCT01900015|"~     Primary Objective:~      To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to~     rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen~     on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among~     HIV/HCV-coinfected patient.~      Secondary Trial Objective:~        1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in~          the grade of HS between patients continuing with EFV plus two nucleoside analogs and~          those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside~          analogs.~        2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50~          copies/mL) after switching.~      Design:~      Open-label, randomized clinical trial to evaluate safety (phase IV)~      Condition:~      HIV and HCV coinfection.~      Intervention:~      Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV~     to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current~     regimen.~   "
88415|NCT01900002|"~     The goal of this clinical research study is to learn about the safety of combining sorafenib~     with TheraSphere in the treatment of patients with advanced liver cancer.~   "
88416|NCT01899989|"~     The purpose of this study is to determine if the use of exploratory immunologic biomarkers,~     functional MRI images can serve as early predictors for response of NSCLC. It also will~     provide important information on the perceived side effects from a patient perspective.~     Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which~     chemotherapy is not part of the standard of care). Patients will only receive stereotactic~     body radiation therapy (SBRT) per standard dose guidelines.~   "
88417|NCT01899976|"~     The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered~     Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The~     study is designed to support the regulatory requirement of a 510(k) marketing application in~     the United States.~   "
88418|NCT01899963|"~     In this province, optometrists are often responsible for contacting the retinal specialists'~     office to arrange patients to be examined for suspected emergencies or more routine~     referrals related to the eye. This is often done by faxing a referral form to the~     specialists' office, where the retinal specialist will examine the information presented in~     the referral form and make a decision on when the patient should be seen. This current~     method has some important considerations, such as the difficulty of transmitting clear~     images of the back of the eye over fax. Having this information could help the retinal~     specialist in determining when the patient should be seen, especially in terms of booking~     additional tests or when treatment should be given.~      Teleophthalmology is a branch of telemedicine that delivers eye care through digital~     equipment and telecommunications technology. It offers some unique advantages, such as the~     ability to be integrated with electronic health records, the ability to be viewed by~     multiple members of the health care team, and potentially reduce wait times and travel times~     to the ophthalmologist.~      However, there is no comparison known to the study team between whether patients being~     referred from optometrists to retina specialists through a teleophthalmology system will be~     treated earlier than patients through a conventional fax system. This study aims to examine~     and provide more information on this topic.~   "
88419|NCT01899950|"~     Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical~     spectrum and variable age of onset. Classically, children with NPC demonstrate neurological~     dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and~     eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to~     move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic~     episodes, and progressive dementia. There is no curative treatment for NPC and it is a~     lethal disorder. The purpose of this protocol is to obtain both baseline and rate of~     progression data on a clinical and biochemical markers that may later be used as outcome~     measures in a clinical trial. Specifically, this study will examine and characterize the~     longitudinal progression of neurocognitive symptoms of NPC with the goal of identifying~     early markers of disease progression that may be utilized in later trials to evaluate~     treatment efficacy.~   "
88420|NCT01899937|"~     Flow mediated dilation (FMD) of the brachial artery has been widely used as a non-invasive~     measure of endothelial function. FMD independently predicts future cardiovascular events and~     can be readily influenced by pharmacological, dietary or lifestyle interventions. However,~     the interpretation of FMD data is currently importantly hampered by differences in~     measurement methodologies and analysis techniques between laboratories. These differences~     result in large variation of 'normal' values between laboratories, highlighting the need for~     adopting widely supported and evidence-based guidelines.~   "
88421|NCT01899924|"~     The main objective of this study is to describe differential cognitive processing of various~     stimuli by a population of control subjects and a population of patients with selective~     cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and~     high-density EEG picked up system.~   "
88422|NCT01899911|"~     A clinical study designed to determine the accuracy of the peripheral capillary oxygen~     saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood~     saturation level.~   "
88423|NCT01899898|"~     One third of children with epilepsy have seizures that are medically intractable.~     Uncontrolled seizures pose a variety of risks to children, including higher rates of~     mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible~     option for most children with refractory epilepsy. The ketogenic diet and the modified~     Atkins diet have been shown to be effective alternative treatments in children with~     refractory epilepsy. However, these need parents to be educated, and understand complex~     instructions of weighing foods and diet preparation. Therefore, children with parents with~     low levels of literacy and poor socioeconomic status have not been able to benefit from~     these therapies. Also, the paucity of trained dieticians and limited availability of labeled~     foods in resource-constraint settings has made these dietary therapies even more~     inaccessible.~      This study aimed to to develop a simple-to-administer variation of the modified Atkins diet~     for use in children with refractory epilepsy and to evaluate the efficacy and tolerability~     of this simplified modified Atkins diet in children with refractory epilepsy in a randomized~     controlled open-label trial.~   "
88427|NCT01899846|"~     This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in~     blood throughout pregnancy~      There will be 3 cohorts of subjects~      Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same~     time each day for one week following their first dose of Makena and will have blood drawn~     immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2~     (32 - 36 weeks)~      Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days~     after their first dose of Makena. Subjects will have daily blood draws for one week~     following a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately~     prior to 2 successive doses during Epoch 2 (32 - 36 weeks)~      Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days~     after their first dose of Makena. Subjects will have blood drawn immediately prior to 2~     successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a~     dose of Makena given during Epoch 2 (32 - 36 weeks)~      A maximum of 10 subjects will be monitored on selected days following a completed course of~     Makena therapy to determine the terminal elimination phase.~   "
88428|NCT01899833|"~     This study will compare how well a new radiolabeled imaging agent ECDG compares to the~     current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and~     stress cardiac test as documented from results of a coronary angiogram (if performed).~   "
88429|NCT01899820|"~     Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated~     malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of~     Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line~     treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives~     are the most rapidly acting of all the current antimalarial drugs and recognition of their~     potential role as a component of combination therapy have led to several large trials aimed~     at assessing different combinations of existing drugs, and to the specific development of~     new combination drugs.~      This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria~     combination drugs in different sites across Kenya (2) elucidate the markers of resistance to~     ACTs through molecular genetics and in this process further strengthen capacity in the~     proposed study sites as well as improve links between research and control ultimately to~     influence malaria treatment policy and practice.~      Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess~     the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative~     drug. The network will determine antimalarial drug efficacy using standardised protocols and~     collate clinical responses and adverse events. Molecular markers to artemisinin resistance~     will be investigated by molecular sequencing and comparison of parasite profiles in drug~     failure cases. Recrudescence or re-infections will be differentiated by analysis of the~     MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these~     studies will be captured into a database developed by the network. The latter offers several~     advantages including~        -  Working towards the standardization of methodologies and common protocols as a way of~          comparing data across sites~        -  Pulling together datasets and conduct a multi-centre analysis~        -  Sharing and coordinating quality assurance mechanisms~   "
88430|NCT01899807|"~     The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi~     craniectomies. The frequency of infections and rupture of skin will be studied, which is a~     reoccurring problem with currently used bone graft substitutes in this subject population.~     In addition, the quality of life before and after implantation will be evaluated as well as~     the bone regeneration around implant.~   "
88431|NCT01899794|"~     The purpose of this study is to determine in female patients who suffer mixed urinary~     incontinence (MUI) the following: 1) the proportion of patients that are cured or improved~     by a single modality therapy (drug or surgery alone), cured or improved by a combined~     therapy (drug and surgery in any order) or non-responders to any of theses therapies; 2)~     which of the combined therapy sequences (surgery first, then followed by oral drug therapy~     or oral drug therapy first, then followed by surgery) is the most effective in patients~     needing combined therapy.~   "
88432|NCT01899781|"~     The investigators assume that simple hand lacerations involving flexors or extensors~     tendons, do not require prophylactic antibiotic treatment to prevent wound infection.~   "
88433|NCT01899768|"~     This study is designed to evaluate the effect of GSK2339345 relative to placebo on the~     number of coughs in patients with Chronic Idiopathic Cough (CIC) administered by an Aqueous~     Droplet Inhaler (ADI). The primary aim is to investigate the efficacy of GSK2339345 on~     reducing objective cough frequency in CIC patients. The secondary aim of this study is to~     investigate the efficacy of GSK2339345 in inhibiting a hypertussive cough response elicited~     by capsaicin and citric acid in CIC patients which have a hyperresponsive cough reflex.~      Following the screening visit, all eligible subjects will attend the unit for dosing at~     Visits 1-7. At Visits 1, 2 and 3 (Part A of the study), subjects will receive two doses of~     either GSK2339345 or placebo, 4 hours apart and will undergo 8 hours of cough monitoring. At~     Visits 4 and 5 (Part B of the study) and Visits 6 and 7 (Part C of the study), subjects will~     be administered a single dose of either GSK2339345 or placebo. Subjects will then undergo~     capsaicin (Part B) or citric acid (Part C) tussive challenge and will undergo cough~     monitoring for 1 hour post dose.~      The maximum study duration will be approximately 11 weeks, including 3 weeks screening and 2~     weeks follow-up. Approximately 30 patients will be randomised into the study, such that~     approximately 24 patients complete dosing and critical assessments.~   "
88434|NCT01899755|"~     GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal~     antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be~     conducted in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of~     groups of 12 subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will~     consist of a group of 9 subjects, all on active treatment (adalimumab).~   "
88435|NCT01899742|"~     The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg)~     once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects~     with COPD who have received tiotropium and continue to have symptoms while on tiotropium.~   "
88457|NCT01899456|"~     The study is aiming to document the safety and effectiveness of renal denervation in~     patients after renal transplantation with hypertension. Catheter-based renal denervation~     will be performed using CE marked, percutaneous Symplicity catheter.~   "
88458|NCT01899443|"~     Primary total knee or total hip replacement surgeries are costly high volume procedures &~     outcomes may be affected by surgical & care processes & individual patient characteristics.~     The primary hypotheses is that non compliance with recommended practice impacts patient~     outcomes (e.g. the likelihood of complications following surgery). The primary aims of the~     study are to evaluate the links between processes & outcomes & if possible develop a model~     that will improve patient outcomes & reduce unnecessary practice variation whilst~     considering costs.~   "
88436|NCT01899729|"~     IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors~     (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be~     encountered during infection) and endogenous nucleic acids (as might be released during~     tissue damage during autoimmune disease). In vitro and in multiple animal models of~     autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In~     Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC~     injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were~     well-tolerated, with mild injection site reactions and no pattern of systemic reactions or~     laboratory changes.~      The current study represents the first clinical trial of IMO-8400 in patients with active~     autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of~     activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist~     which demonstrated clinical improvement in this patient population.~   "
88437|NCT01899716|"~     The study aimed to evaluate the use of exercise as a complementary strategy to treat severe~     major depression in inpatients.~      Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe~     depressed inpatients.~   "
88438|NCT01899703|"~     This will be a randomized, double-blind, placebo-controlled study to assess safety and~     tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC)~     and symptoms of pruritus. It is a double-blind, crossover study with subjects receiving~     placebo or GSK23306772 in random order during two 14-day treatment periods. Additionally,~     the study will determine GSK2330672 exposure and interactions with ursodeoxycholic acid~     (UDCA). The total duration of subject participation will be 14 weeks for screening (45 days)~     and the treatment period. Subjects who are eligible for enrolment will participate in a~     2-week placebo run-in period. Subjects will be randomized in a crossover fashion (Sequence 1~     / Sequence 2) to receive placebo or GSK2330672 treatment during two consecutive 2-week study~     periods. Subjects will then participate in a 2-week placebo dosing period ending in~     follow-up assessments. Study results will be utilized to form a benefit: risk profile for~     GSK2330672 in PBC that will determine plans for progression to exploratory efficacy trials~   "
88439|NCT01899690|"~     This study is a randomized controlled non-blinded double arm study examining the effect of~     routine postoperative oral antibiotic therapy in preventing postoperative surgical site~     infections after breast reconstruction. The investigators hypothesize that use of~     prophylactic antibiotics after breast reconstruction does not reduce surgical site~     infections.~   "
88440|NCT01899677|"~     The aim of this prospective double blinded randomised study is to investigate the efficacy~     of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum,~     Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama~     acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory~     pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing~     enterocolitis pathogenesis in very low birth weight neonates.~   "
88441|NCT01899664|"~     The goal of the investigators work is to establish how nerve transfers can be best used to~     improve upper extremity function in patients with cervical level spinal cord injury (SCI).~     The investigators' hypothesis is that nerve transfers are safe and effective and will~     improve function and quality of life in patients with loss of upper function due to spinal~     cord injury. The investigators plan on looking at upper limb function, and health-related~     quality of life in patients before and after surgery to better understand how patients~     benefit from these treatments.~      A nerve transfer procedure can be used to rewire the system to make some muscles work again~     following SCI. The nerve transfer procedure (which is done in the arm and not at the level~     of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the~     brain to a muscle that became disconnected following that injury. A donor nerve is taken~     from another muscle whose use is not essential and then transferred to help in providing~     more a more critical function.~      For example, one type of nerve transfer is done to restore the lost ability to pinch or~     grasp small objects between the fingers that occurs in many patients with cervical SCI. In~     this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used~     because the biceps muscle is also working to flex the elbow. This donor nerve is cut and~     re-attached to the nerve going to muscles in the forearm that provide pinch by bending the~     tips of the thumb and index finger.~      Because the nerve transfer procedure involves cutting and reattaching nerve and muscle~     tissues, time is required to regenerate working connections between the nerves and muscle as~     well as to allow the brain to relearn how to use and strengthen that muscle.~   "
88442|NCT01899651|"~     Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add~     to information needed to diagnose neurological problems in infants - both preterm and term.~     The investigators propose a method to test these technologies in the preterm population to~     determine its safety and ease of use. The investigators will test on preterm infants of~     30-34 weeks gestation, starting first with the older infants (32-34 weeks) then moving down~     to the smaller population (30-32 weeks). In both groups the investigators will start with a~     short time period and gradually extend the time as safety is established.~      All studies will be conducted at Shands Teaching Hospital at the University of Florida.~   "
88443|NCT01899638|"~     This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg~     and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.~   "
88444|NCT01899625|"~     This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability~     and preliminary efficacy of an MI-based program for weight loss in young adults.~   "
88445|NCT01899612|"~     Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful~     intercourse. The underlying pathology is unknown. Since symptoms are comparable to those~     found in infectious vaginitis during the reproductive life stage, the investigators~     hypothesize that the vaginal milieu in symptomatic postmenopausal women is comparable to~     inflammation in vaginitis. The investigators therefore study vaginal cytokines in~     symptomatic and asymptomatic postmenopausal women.~   "
88446|NCT01899599|"~     Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced~     ovarian, fallopian tube or primary peritoneal cancer.~   "
88447|NCT01899586|"~     The aim of this study is to devise a sufficiently high intensity training program that~     provided an optimal stimulus to remove the peripheral factors known to reduce functional~     capacity, and can be cardiovascular and orthopedically well tolerated by the elderly.~     Findings from study laboratories have suggested that a regional specific training stimulus~     (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel~     combination of resistance training and aerobic training applied simultaneously, and in a~     serial manner, to specific regions of the body. It involves high-intensity and frequency~     muscle contractions, generating a targeted exercise stimulus, without producing excessive~     cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at~     multiple, strategically selected peripheral sites, in a serial manner will elicit local~     vascular and muscular changes, thereby preparing individuals at elevated risk of losing~     independence, to respond and progress more favorably to whole-body exercise.~   "
88448|NCT01899573|"~     The study is designed to demonstrate the safety, feasibility and potential efficacy of using~     the AccuCinch® System to reduce functional mitral regurgitation.~   "
88449|NCT01899560|"~     The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically~     ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP).~     Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung~     volume in order to prevent repetitive opening and closing of unstable lung units and reduce~     the strain induced by ventilation. In addition, recruitment is effective in improving~     oxygenation. Variety of recruitment maneuver have been described, the most commonly used is~     the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds.~     Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance.~     Staircase recruitment maneuver (SRM) involves a progressive increase in positive end~     expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to~     increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The~     positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio~     between lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP~     to obtain a positive end-expiratory transpulmonary pressure is high. The only way for the~     time being to know the transpulmonary pressure and the ratio between lung and chest wall~     elastance is the use of esophageal catheter. A non-invasive method for measuring the lung~     elastance by measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be~     used to avoid the use of esophageal catheter.~   "
88450|NCT01899547|"~     The purpose of this study is to evaluate the safety and oncological feasibility of~     laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.~   "
88451|NCT01899534|"~     To compare e-screening versus usual screening on: 1) women's and healthcare providers' views~     on feasibility and acceptability; 2) rates of detection of prenatal and postpartum~     depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness;~     5) psychometric properties. We also aim to identify factors associated with feasibility of~     e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields~     similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk~     of disclosure is significantly lower and benefit of disclosure is significantly higher in~     the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and~     postpartum depression and anxiety; 5) features of e-screening are significantly associated~     with feasibility and acceptability, whereas demographic factors are not; and 6) reliability~     and validity indices of ALPHA and EPDS are strongly correlated for both administration~     modes.~   "
88452|NCT01899521|"~     This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine~     (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if~     either dietary zinc or S-adenosylmethionine (SAMe) can augment lung immune defenses in~     alcoholics and thereby decrease the risk of lung injury and infection.~   "
88453|NCT01899508|"~     This study is looking at whether virtual reality combined with pain coping skills training~     helps reduce pain in people who suffer from OA of the knee. Eligible participants will be~     asked to come into the study offices for one visit where they will fill out a couple of~     questionnaires, do some low impact performance tasks and be taught pain coping skills while~     looking into a 3D virtual reality viewer.~   "
88454|NCT01899495|"~     Previous studies have demonstrated that single nucleotide polymorphisms (SNPs) of the~     sodium-bicarbonate co-transporter gene (SLC4A5) are associated with hypertension. We tested~     the hypothesis that SNPs in SLC4A5 are associated with salt sensitivity of blood pressure in~     185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low~     sodium (Na+) and 7 days of high Na+ intake. Salt sensitivity was defined as a ≥7-mm Hg~     increase in mean arterial pressure during a randomized transition between low and high Na+~     diet.~      A total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for~     association. Association analyses with salt sensitivity revealed 3 variants that associated~     with salt sensitivity. Of these, 2 SNPs in SLC4A5 (rs7571842 and rs10177833) demonstrated~     highly significant results and large effects sizes, using logistic regression. These 2 SNPs~     had P values of 1.0×10−4 and 3.1×10−4 with odds ratios of 0.221 and 0.221 in unadjusted~     regression models, respectively, with the G allele at both sites conferring protection.~     These SNPs remained significant after adjusting for body mass index and age (P=8.9×10−5 and~     2.6×10−4 and odds ratios 0.210 and 0.286, respectively). Furthermore, the association of~     these SNPs with salt sensitivity was replicated in a second hypertensive population.~     Meta-analysis demonstrated significant associations of both SNPs with salt sensitivity~     (rs7571842 [P=1.2×10−5]; rs1017783 [P=1.1×10−4]).~      In conclusion, SLC4A5 variants are strongly associated with salt sensitivity of blood~     pressure in 2 separate white populations.~   "
88455|NCT01899482|"~     The purpose of this study is to compare functional status and quality of life of a group of~     patients with chronic venous insufficiency treated with manual lymphatic drainage with a~     group not treated with manual lymphatic drainage.~      Investigators hypothesized that manual lymphatic drainage can improve:~        -  quality of life,~        -  functional status,~        -  calf muscle strength,~        -  ankle range of motion,~        -  edema,~        -  severity of disease,~        -  and symptoms.~   "
88491|NCT01899014|"~     Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a~     sensitive molecular tracer for PET-CT imaging that is taken up in activated cells and, as~     such, is able to identify active inflammatory sites.~   "
88461|NCT01899404|"~     The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation~     with chemotherapy followed by internal radiation, called brachytherapy. Currently,~     brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called~     T2-weighted (T2W) MRI.~      The main purpose of this study is to determine whether the following imaging tests can~     visualize the tumor better for planning the brachytherapy treatment:~        1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced~          MRI (DCE-MRI); and~        2. an x-ray test called positron emission test (PET) performed with a sugar dye called~          FDG. MRI-guided brachytherapy is resource-intensive and not widely available.~   "
88462|NCT01899391|"~     Right now it is not possible to predict which patients are going to react more to RT. Many~     things could affect patient's response to radiation. One of the factors is whether the~     person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some~     evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and~     this can be used to predict the sensitivity of individual patients. The investigators will~     be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients~     exposed to both computed tomography (CT) scan and RT treatment. This will help us to~     understand why different individuals show differences in side effects following RT.~   "
88463|NCT01899378|"~     Here the investigators propose to preliminarily investigate the safety and effects of~     probiotics in infants in Bangladesh through a pilot randomized clinical trial. The~     investigators hypothesize that two probiotics are safe for infants in Bangladesh and may~     have an effect on biomarkers of gut health and immunity. The specific aims of this pilot~     are: i) to confirm the safety of administering probiotic strains to infants in low-income~     countries, ii) to determine the effects of dosing frequency on colonization and persistence~     of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and~     microbiota structure.~   "
88464|NCT01899365|"~     Background :~      Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents~     the 6th cause of death. CAP also frequently associates with other disorders responsible for~     admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major~     pathogen that is commonly involved and frequently leads to severe infection and admission.~     Categories at risk for this pathogen have been determined, and can be proposed~     anti-pneumococcal vaccination (APV) that efficiently and safely protects from this~     microorganism.~      In the context of US health services, monocenter pilot experiences have reported improvement~     of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in~     New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at~     risk were proposed vaccination at ED. To obtain these results, medical students were~     specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another~     single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to~     45.4%) when physicians were alerted for pneumococcal risk by the software they usually~     utilized at bedside. However these experiences remain sparse as additional dedicated~     resources are required or patients and attending ED physicians can be reluctant to proceed~     to vaccination at ED.~      Mobile phone and derived communication modalities are current vectors to deliver information~     in several fields including education and medicine. Initially used in developing countries,~     short-message services (SMS) have improved behaviour of patients in various medical areas.~     In France, the investigators have observed that most patients above 50 years of age admitted~     after ED visit are equipped with mobile phone and can receive alerts by SMS.~      These observations prompt us to propose a multifaceted procedure to improve APV after ED~     visit in at-risk patients, combining structured oral interview, written information and SMS~     as reminders.~      Purpose : The investigators hypothesized that~        -  a multifaceted intervention to promote anti-pneumococcal vaccination combining a~          structured oral interview, a written information to patient and his/her general~          practitioner, and a series of 3 SMS,~        -  improves anti-pneumococcal vaccination at 6 months,~        -  in at-risk patients (65+ years) visiting the emergency department. In order to answer~          this question, the investigators designed an interventional prospective multicenter~          randomized study (cluster).~   "
88465|NCT01899352|"~     Tracheostomy is worldwide used for critically ill patients. The aim of our study is to~     assess the mortality, quality of life, laryngeal function, procedures, early and late~     complications of tracheostomy performed for critically ill patients admitted in intensive~     care units.~   "
88466|NCT01899339|"~     Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an~     improved right ventricular function 72 hours post treatment.~   "
88467|NCT01899326|"~     This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works~     for stem cell mobilization in patients with multiple myeloma undergoing stem cell~     transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as~     desipramine hydrochloride, helps stem cells move from the patient's bone marrow to the blood~     so they can be collected and stored.~   "
88468|NCT01899313|"~     This Phase I behavior therapy development study seeks to improve treatment outcomes for~     methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy-~     (CBT-) based short message service (SMS) text messaging intervention.~   "
88469|NCT01899300|"~     The purpose of this study is to establish clinical proof of concept of temporary indwell of~     the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory~     benign esophageal strictures caused by caustic ingestion.~   "
88470|NCT01899287|"~     Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The~     burden of the disease is high in a personal as well as in a socio-economic context. There is~     a need for evaluating new strategies to improve the prognosis for OHE patients. The~     objectives of the study is to evaluate the effect of group education on sick lave,~     health-related quality of life and disease severity among individuals with newly notified~     OHE.~      The trial population consist of individuals from the Capital Region of Denmark and Region~     Zealand with a suspected skin-related industrial injury notified to the Danish National~     Board of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue~     until the designed number of participants have been included.~      All participants will be assessed in a questionnaire at time T=0 with regard to: self~     evaluated disease severity, health-related quality of life, skin protective behaviour,~     knowledge of skin protection, self-efficacy, work-role function and if active in workforce.~     The participants will then be randomised. The intervention group will be invited to~     participate in the educative course, and work place visits will be offered. In the~     intervention group a telephone hot line will be available for further questions concerning~     these topics. The control group will not have access to any of these interventions. Both~     intervention group and control group will be contacted every eighth week about number of~     days of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire~     at T=12 months. There will be a total of 742 included participants.~   "
88471|NCT01899274|"~     The purpose of the study is to assess whether an electronic self-management tool,~     specifically an iPhone application entitled bant, can improve glycemic control in~     Adolescents who have Type 1 Diabetes Mellitus (T1DM).~   "
88476|NCT01899209|"~     Obstructed Defecation is a profoundly disabling condition. Many different surgical~     procedures has been introduced to treat patients affected by this disease. The most used are~     STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of~     comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to~     compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and~     anatomical results.~   "
88477|NCT01899196|"~     Protocol date and version RCB Id : 2013-A00547-38~      Etude ANRS EP 52 PIECVIH Title of Study: EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN~     HIV-INFECTED PATIENTS~      Short title - PIECVIH study~      Sponsor French National Institute for Health and Medical Research - French national agency~     for research on AIDS and viral hepatitis (Inserm-ANRS)~      Coordinating Investigator Pr Franck BOCCARA Service de Cardiologie, Hôpital St Antoine~     INSERM UMRS 938 Paris, UPMC, Institut hospitalo-Universitaire- Institute of Cardiometabolism~     and Nutrition (IHU-ICAN) 184, rue du Faubourg Saint-Antoine 75571 PARIS Cedex 12 Tél. : 01~     49 28 24 49 - Fax : 01 49 28 26 83 Courriel : franck.boccara@sat.aphp.fr~      Participating country: France~      Objectives Principal objective To compare the inflammatory profile of the epicardial adipose~     tissue (EAT) between people living with and without HIVwho present with coronary heart~     disease and will undergo a coronary artery bypass graft (CABG)~      Secondary objectives~        -  To compare the volume of EAT between people living with and without HIV who present~          with coronary heart disease~        -  To evaluate the relationship between the abnormalities of the expression profiles of~          the adipocytokines and cytokines with the atherosclerotic lesions.~        -  To evaluate the relationship between the abnormalities of the expression profiles of~          the adipocytokines and cytokines of the EAT with the circulating levels and metabolic~          parameters.~        -  To compare the histological and inflammatory profiles of the EAT with the subcutaneous~          adipose tissue for each patient individually.~      Methodology multicentric, comparative study~      Estimated enrollment 31 participants in total~        1. st group of- 15 people living with HIV undergoing CABG (coronary heart disease HIV+~          group)~        2. nd group of- 16 people without HIV- undergoing CABG (coronary heart disease HIV- group)~          People without HIV-will be matched to people living with HIV+ by : age (± 5 years) and~          sex Outcomes~      Primary outcome:~      Comparative analysis of the inflammatory profile of the EAT : expression profile of the pro~     and anti inflammatory cytokines and adipokines within the EAT in both groups of participants~     : coronary heart disease HIV+ and HIV- groups~      Secondary outcomes :~        -  Determination of the EAT volume by echocardiography and cardiac scanner for both groups~        -  Macroscopic profile of the EAT : adipocytes, fibrosis, endothelial cell density)~        -  RT-PCR analyses : renin, adiponectine, PPARɣ~        -  Comparatison of the inflammatory and macroscopic profiles between the EAT and the~          subcutaneous adipose tissue in the two groups by ARN messagers analysis.~      Eligibility Inclusion criteria HIV+ group~        -  Men or women above the age of 18 years old, HIV1 seropositive for more than 6 months~        -  Individual undergoing, for the first time, cardiac surgery for CABG~        -  Affiliated with a social security regimen (the AME is not a social security regimen)~        -  Signed the consent form~      HIV- group~        -  Men or women above the age of 18 years old, HIV seronegative~        -  Individuals undergoing, for the first time, cardiac surgery for CABG~        -  Affiliated with a social security regimen (the AME is not a social security regimen)~        -  Signed the consent form~      Non-inclusion criteria History of surgery for CBAG and/or congenital heart defect- being~     under the tutorship or guardianship of the state or in custody of the justice system.~      Statistical methods Categorical variables will be compared using Fisher's exact test.~     Continuous variables will be compared using the Student's t-test (parametric) and the~     Wilcoxon-Mann-Whitney test (non-parametric) as appropriate considering the data~     distribution. (statistical analysis software STATA 11 (StataCorp, Texas, USA))~      Provisional study planning and timetable Study start date: July 2013 Enrollment period: 32~     months Subject participation duration: 24 hours Total study duration: 32 months Estimated~     study completion date: end of March 2016~   "
88478|NCT01899183|"~     The effectiveness of surgical fundoplication in treating classical reflux symptoms is well~     documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly~     secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.~      The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15%~     to 95%; the spread of these data is largely attributable to disparate study design and~     methodology, patient selection, and outcome metrics.~      In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough~     allegedly secondary to GERD and to eventually identify the preoperative clinical profile~     which could predict those positive effects, we considered two groups of patients presenting~     with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux~     surgery.~   "
88479|NCT01899170|"~     Chronic neuropathic pain affects millions of individuals worldwide. It causes marked~     reduction of health, utility and quality of life and represents a considerable economic~     burden to society due to loss of work capacity and large treatment expenses. The proposed~     project will explore new and rational methods for deep brain stimulation treatment of~     patients with severe chronic neuropathic pain, resistant to conventional treatment. Deep~     brain stimulation is a neurosurgical procedure in which a small stimulating electrode is~     implanted into deep brain areas. Furthermore, we will utilize new positron emission~     tomography neuroimaging and a new prototyped technology, called targeted transcranial~     magnetic stimulation, to predict the outcome of deep brain stimulation and localize brain~     regions with maximum symptom relief for each patient. This will optimize the selection of~     patients for deep brain stimulation and provide a rational customized choice of brain target~     for each patient, without surgical intervention. Novel techniques will be validated on~     healthy volunteers and at the same time provide new insights into the mechanisms underlying~     brain stimulation and pain perception. The project has great clinical impact, potential for~     innovative development and industrial spin-out, facilitates exchange for Danish research~     talents and senior researchers with Stanford University and California Pacific Medical~     Research Institute in San Francisco, and unites world leading experts in pain research and~     clinical treatment to achieve its goals.~   "
88480|NCT01899157|"~     A prospective cross-sectional study evaluates nutritional status and its relationship to the~     related factors in Thai HIV-infected patients who attending in out patient clinic.~   "
88481|NCT01899144|"~     This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,~     single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with~     persistent asthma. The primary purpose of this study is to compare the efficacy and safety~     of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered~     dose levels equivalent to 90 mcg and 180 mcg of albuterol base.~   "
88482|NCT01899131|"~     1. To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok®~          microchannels permanent abutment/ new Laser-Lok® implant assembly by performing~          clinical and radiographic evaluations.~        2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and~          soft tissues.~        3. To perform clinical and radiographic evaluations on these abutment/implant assemblies~          up to 2 years.~   "
88483|NCT01899118|"~     Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a~     standard treatment of locally advanced rectal adenocarcinomas, which correlates better local~     control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody~     against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic~     effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to~     evaluate the efficacy of the combination of Nimotuzumab administered concurrently with~     neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to~     further investigate its side-effect and toxicity.~   "
88484|NCT01899105|"~     This study is designed to investigate the effect of food on the relative bioavailability of~     2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet~     formulations.~   "
88485|NCT01899092|"~     The study is a first in man, dose escalation study that will measure the safety and efficacy~     of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5~     dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects~     will be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending~     on the dose level, the next set of subjects will be dosed. The study drug is a gene therapy~     treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected~     cells. Once the study drug is given, it cannot be withdrawn. Additionally, once an~     individual receives a dose, he or she will not be able to receive a second dose, but will~     remain eligible to receive most other HCV treatments.~   "
88486|NCT01899079|"~     The primary objective of this study is to assess the extent to which the Prosigna™ Breast~     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment~     recommendations regarding adjuvant chemotherapy and actual treatments received for patients~     with early-stage breast cancer.~   "
88487|NCT01899066|"~     This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab~     (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to~     chemotherapy alone.~   "
88488|NCT01899053|"~     This study is a multicenter, open-label, phase 1b trial of MLN0128 (an oral mTORC1/2~     inhibitor) in combination with MLN1117 (an oral inhibitor of the PI3K (alpha) isoform) when~     administered to adult patients with advanced nonhematological malignancies.~   "
88489|NCT01899040|"~     This is a randomized, blinded study designed to assess the efficacy of a portable,~     non-invasive neuromodulation system for the treatment of episodic migraine headaches.~   "
88490|NCT01899027|"~     The primary objective of this study is to test the hypothesis that twice overnight high-dose~     rosuvastatin loading before RNA followed by 3-month treatment with regular doses of~     rosuvastatin can reduce both the acute and late renal artery damage.~   "
88492|NCT01899001|"~     The purpose of this study is to help determine the best treatment plan for women with PCOS~     who are overweight or obese and experiencing significant symptoms of depression and anxiety.~      Specifically, the investigators are attempting to see if there is a difference between~     cognitive behavioral therapy in combination with nutritional counseling in improving mood~     symptoms, response to stress, and risk factors for heart disease compared to nutrition~     counseling alone. The investigators hypothesize that combined treatment with Cognitive~     Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.~   "
88493|NCT01898975|"~     Optimal fluid management has been considered as crucial part to determine postoperative~     outcome and organ function. Recently developed, non invasive cardiac output~     measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO)~     monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from~     NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of~     this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid~     responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive~     patients using gray zone approach.~   "
88494|NCT01898962|"~     Patients with metastatic cancer are usually treated with systemic therapy (treating the~     entire body) with the assumption that any localized treatment of clinically apparent~     metastases would not impact survival. In the setting of increasingly effective systemic~     therapy and limited metastatic disease, aggressive treatment to clinically active sites of~     disease (alone or in addition to systemic therapy) may improve survival.~   "
88495|NCT01898949|"~     Human fat tissue is essentially white fat, the main function of which is to store excess~     energy intake, and to release it when necessary. Brown fat is far less abundant and is~     present in the body to burn fat (and thus energy) to generate heat to maintain body~     temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are~     exposed to cold on a chronic basis, brown fat expands and becomes more active, and~     consequently burns more energy. The amount of brown fat is higher during winter, and daily~     short (20 minutes) exposures to cold might be sufficient to induce its activity.~      We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for~     four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased~     proportionally (the increase in CIT and DIT will be correlated).~   "
88496|NCT01898936|"~     Organ transplant recipients (OTR) have an increased risk of non-melanoma skin cancer, in~     particular squamous cell carcinoma (SCC), often developing in areas of field cancerization,~     areas with multiple precancerous actinic keratoses. The risk of developing SCC in OTR is~     65-100-fold the normal population (Jensen 1999, Lindeløf 2000), and this cancer often runs a~     more aggressive course with metastasis reported to occur in 5-8% of cases (Berg 2002). The~     treatment options in field cancerization are limited. In Norway, the registered treatment~     alternatives are the topical immune response modifier imiquimod and photodynamic treatment.~     Neither of these treatments has shown long term beneficial effects.~      In this study, we will study the effect of pre-treating the skin with ablative, fractional~     carbondioxide laser before photodynamic therapy in a group of OTR with multiple actinic~     keratoses~   "
88497|NCT01898923|"~     The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1~     ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers~     for up to 16 weeks.An additional objective of this study is to collect safety information~     including adverse events and clinical laboratory abnormalities.~   "
88498|NCT01898910|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD)~     versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed~     after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).~   "
88499|NCT01898897|"~     The study hypothesis is that regional anesthesia offers better outcome for the patients who~     underwent robot assisted laparoscopic urogenital surgery.~   "
88500|NCT01898884|"~     The objectives of the study are:~        -  To evaluate the safety and tolerability of single and multiple oral doses of VP 20629~          in subjects with Friedreich's ataxia (FA). [Primary]~        -  To characterize the pharmacokinetics of VP 20629 by investigation of the plasma~          concentration-time profile following single and multiple oral doses in subjects with~          FA. [Secondary]~        -  To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and~          malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple~          oral doses in subjects with FA. [Exploratory]~   "
88501|NCT01898871|"~     The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a~     new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of~     moderate acute malnutrition in children.~   "
88502|NCT01898858|"~     The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during~     a short constant load exercise in 4 conditions :~        -  normoxia~        -  hypoxia~        -  hypercapnia~        -  association hypoxia and hypercapnia~   "
88503|NCT01898845|"~     This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose~     for expansion.~   "
88504|NCT01898832|"~     The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant~     women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role~     in progress of intrahepatic cholestasis of pregnancy.~   "
88505|NCT01898819|"~     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical~     prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of~     pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in~     intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.~   "
88525|NCT01898559|"~     This study examines the effects of smoking little cigars in different groups of smokers. The~     investigators are focusing on differences in how smokers' bodies break down and eliminate~     nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they~     break down and eliminate nicotine from their bodies more quickly. Other people are slower~     metabolizers meaning they break down and eliminate nicotine more slowly. The investigators~     are comparing these two groups of smokers when they switch to smoking cigars instead of~     cigarettes.~   "
88506|NCT01898806|"~     Alopecia areata is a common form of hair loss which reportedly occurs in up to 1.7% of the~     population at some time in their life. Alopecia areata is apparently triggered when the~     individual's own immune system attacks hair follicles on the scalp or body resulting in hair~     loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every~     hair on the scalp and body (alopecia universalis). Currently, there are limited treatment~     options for alopecia areata and unfortunately, the treatments utilized have never been~     rigorously tested in a placebo controlled trial.~      Triamcinolone (Kenalog) is a steroid solution that has been used as treatment for alopecia~     areata for over 50 years. It is administered via injection into the scalp and appears to~     have some efficacy for patients with mild to moderate alopecia areata. The investigators~     currently do not have objective data on the frequency of occurrence of successful regrowth,~     the duration of response or the incidence of side effects. In addition, there is~     disagreement between clinicians regarding the dose of intralesional triamcinolone (IL TAC)~     that is considered most effective.~      This study aims to determine the frequency of response to treatment with 3 concentrations of~     IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of~     side effects compared to treatment with placebo (sterile saline solution). After the 1st 6~     months non or partial responders may be treated for 6 months with open label triamcinolone~     at the dose deemed appropriate by the investigator.~      The investigators will also perform skin biopsies of the scalp and draw blood at selected~     time points in order to examine the immunohistochemical/pathological response in scalp hair~     follicles and the systemic circulation to treatment with IL TAC for alopecia areata.~   "
88507|NCT01898793|"~     This phase I trial studies the side effects and best dose of activated natural killer cells~     in treating patients with relapsed or refractory acute myeloid leukemia and myeloid~     dysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps~     stop the growth of cancer cells. It may also stop the patient's immune system from rejecting~     the donor's natural killer cells. Modified natural killer cells may help the body build an~     immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white~     blood cells (including natural killer cells) to kill leukemia cells.~   "
88508|NCT01898780|"~     The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B~     and C) in horizontal mattress suture are lower than in interrupted suture during~     pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.~   "
88509|NCT01898767|"~     The long-range goal of this protocol is to more completely understand the risks and the~     pathophysiology of asthma exacerbations, in order to develop prevention strategies and/or~     expedite a return to complete control of baseline asthma symptoms.~   "
88510|NCT01898754|"~     The investigators propose to gauge improvements in the rate of durable suppression of viral~     replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope~     Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at~     Coptic Hope Center.~   "
88511|NCT01898741|"~     Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient~     treatment options for locally advanced tumors and metastasized patients. High dose~     radiotherapy with small margins seems feasible with current technical possibilities, e.g. by~     fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and~     technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced~     pancreatic carcinoma.~   "
88512|NCT01898728|"~     The eye contains a lens that focuses light. A clouding of the lens is known as a cataract.~     Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery~     is one of the most commonly performed surgical procedures. Although rare, complications of~     cataract surgery are significant given the number of people who have surgery each year and~     more serious complications may have a significant impact on the vision and quality of~     patients. Endophthalmitis is an infection in the eye and it is one of the worst~     complications of cataract surgery. Most of these infections are caused by bacteria from the~     patient's skin and conjunctiva, which makes cleaning the skin and eye before surgery very~     important. Before cataract surgery, patients receive an umber of eye drops; many surgical~     centers have a combination of medications in a thick gel, so that the medications remain in~     the eye for a long period of time, which may improve their effect. Laboratory studies~     suggest that the antibacterial effect of cleaning solutions may be inhibited by gels but~     this has not been proven, and many believe it to be untrue. This study is to compare the~     amount of bacteria on the eye prior to surgery in patients receiving a gel formulation of~     the medications before surgery as compared to those receiving the same medication in eye~     drop (liquid) form.~   "
88513|NCT01898715|"~     This first-in-human study is designed to establish the safety and tolerability of ATR-101 in~     patients with advanced adrenocortical carcinoma whose tumor has progressed on standard~     therapy. Information will also be collected to determine how long ATR-101 stays in the~     blood, and if any effect on tumor progression is seen. Biomarkers (blood and urine tests)~     will determine if any effects on production of steroid hormones (cortisol, aldosterone,~     estrogen and testosterone) are seen.~   "
88514|NCT01898702|"~     The purpose of this study is to determine whether participation in a diabetes expert~     patients programme course is effective in self-management of a chronic condition such as~     diabetes, if it reduces Haemoglobin A glycosylated levels, improves patient's quality of~     life, and prevents the use of some health services.~   "
88526|NCT01898546|"~     Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular~     obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction~     (STEMI) treated with primary angioplasty.~      Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is~     unknown.~      Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to~     undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO~     and infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory~     analyzing late enhancement cardiovascular magnetic resonance imaging.~   "
88537|NCT01898403|"~     This clinical trial studies lymph node mapping using indocyanine green solution in~     diagnosing patients with malignant melanoma. Diagnostic procedures, such as lymph node~     mapping using indocyanine green solution, may help find out how far the melanoma has spread~     and may help in planning cancer treatment.~   "
88515|NCT01898689|"~     A continuous peripheral nerve block—also termed perineural local anesthetic~     infusion—involves the insertion of a tiny tube (a catheter) through the skin and adjacent~     to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via~     the catheter, providing pain control following surgery. Continuous peripheral nerve blocks~     may be provided in the hospital setting, but the use of lightweight, portable pumps permits~     infusion at home as well. However, it remains unknown if the concentration of the local~     anesthetic influences the block effects; or, is it rather simply the total dose of~     medication that is important. If it is the latter, then the concentration of local~     anesthetic could be increased, allowing a decreased basal infusion rate, which would allow~     patients at home to receive twice the duration of potent pain control since their infusion~     pump local anesthetic reservoir would last twice as long as current practice. In addition,~     if one concentration/dose combination results in less muscle weakness, but with at least~     equivalent analgesia, then the risk of falling might be decreased as well.~      The investigators will test the hypothesis that providing ropivacaine at different~     concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)—but at an equivalent~     total basal (8 mg/hour)—produces comparable effects when used in a continuous~     popliteal-sciatic nerve block.~   "
88516|NCT01898676|"~     A study in stable epilepsy patients comparing levels of valproic acid after administration~     of brand and generic divalproex sodium extended release tablets.~   "
88517|NCT01898663|"~     The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells~     (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk~     soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered~     to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of~     our previously performed preclinical study with DCs vaccine combined with CIK cells, the~     investigators plan to perform the clinical trial.~   "
88518|NCT01898650|"~     Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together~     earlier than normal. This causes the baby to have an abnormally shaped head. These children~     are operated on to prevent or treat increased pressure on the brain, allowing for normal~     development. There is not good evidence of which children with craniosynostosis have~     increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will~     be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to~     obtain several measures of brain metabolism. The investigators will also obtain data which~     are markers of developmental delay.~      The results will also be compared to age and gender matched data from children without~     craniofacial abnormalities.~      There study hypothesis is that patients with craniofacial abnormalities associated with~     intracranial pressure will have decreased metabolic activity compared to control patients.~   "
88519|NCT01898637|"~     The goal of this project is to determine if the change in oxygen saturation during deep~     inspiration (augmented pulse oximetry) can be used as a method to rule out pulmonary~     embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to~     help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive~     patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls~     who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will~     record each patient's oxygen saturation before, during, and after a 2-minute period of deep~     inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in~     milliliters]) using an incentive spirometer. The investigators' central hypothesis is that~     persons with a PE will not respond to augmented pulse oximetry and will not significantly~     improve or normalize their oxygen saturation.~   "
88520|NCT01898624|"~     To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder~     (OAB) patients with coexisting glaucoma.~   "
88521|NCT01898611|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in~     the brain. The investigators already know that a single dose of Ghrelin improves food intake~     immediately after the dose in frail older people. In addition, exercise programs have been~     shown to improve strength and function in older people. In this study, the investigators are~     trying to find out if a joint intervention of ghrelin and resistance training will improve~     walking, balance and leg strength in frail elderly people.~   "
88522|NCT01898598|"~     This randomized, double-blind, placebo-controlled study will assess the efficacy and safety~     of vismodegib with surgery in patients with basal cell carcinoma. Patients will be~     randomized to receive oral daily doses of vismodegib 150 mg or matching placebo. The~     anticipated time on study drug treatment is 12 weeks.~   "
88523|NCT01898585|"~     This open-label, single-arm, multicenter study will assess the safety and efficacy of~     Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma.~     Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable~     toxicity, consent withdrawal, death, reasons deemed by the treating physician or study~     termination.~   "
88524|NCT01898572|"~     It has been hypothesized, based on recent trials, that only early intervention can reduce~     cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This~     finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at~     early, or non-advanced, still modifiable disease stage. However, sparse information is~     available regarding atherosclerosis prevalence and its characteristics at diabetes~     presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major~     goal of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk~     factors, lack of adequate specificity to identify individuals at higher risk. Therefore,~     non-invasive tests, such as carotid ultrasound, have been recommended to better define CV~     risk in several groups of individuals, including those with intermediate risk or with T2DM.~      This clinical study aims to improve the investigators knowledge on cardiovascular disease~     (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that~     carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will~     show a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL)~     individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher~     risk in whom intervention should be more intensive.~      Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM~     will be matched with CONTROL individuals, not only for age and sex (the main determinants of~     atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking~     habit.~      The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a~     cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study~     variables will be carotid ultrasound derived variables. The main aims of the study are: 1)~     to investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to~     characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP~     presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT~     progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines)~     diabetes treatment.~   "
88527|NCT01898533|"~     In this study, investigators intend to measure changes in BOLD contrast in the breast~     induced by breath-holding for subjects receiving radiation therapy to the breast. This study~     will provide the preliminary data and experience needed to successfully apply BOLD to~     quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of~     breast radiotherapy patients. The current study has the following objectives:~        1. To determine the feasibility of BOLD contrast MRI of the breast, induced by~          breath-hold.~        2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for~          females undergoing radiotherapy~   "
88528|NCT01898520|"~     A study to assess the effects of Sativex treatment on spasticity in a population of children~     and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous~     system injury. Efficacy (ability to improve symptoms), safety and tolerability will be~     monitored.~   "
88529|NCT01898507|"~     This study examines the effects of smoking low nicotine cigarettes in different groups of~     smokers. The investigators are focusing on differences in how smokers' bodies break down and~     eliminate nicotine from their systems. Some people are fast metabolizers of nicotine,~     meaning they break down and eliminate nicotine from their bodies more quickly. Other people~     are slower metabolizers meaning they break down and eliminate nicotine more slowly. The~     investigators are comparing these two groups of smokers for their responses to low nicotine~     cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes~     may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine~     levels, and as a result continue to be exposed to significant toxin levels.~   "
88530|NCT01898494|"~     This randomized phase II trial studies how well transoral surgery followed by low-dose or~     standard-dose radiation therapy works in treating patients with human papilloma virus (HPV)~     positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation~     therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet~     known how much extra treatment needs to be given after surgery.~   "
88531|NCT01898481|"~     The purpose of this pilot study is to test the feasibility of identifying and interviewing~     healthcare triads (patients, loved ones and oncologists) in a research study and evaluate~     the influences of patients' loved ones and oncologists on cancer treatment decision-making.~     the study team plans to explore concordance or discordance within the triad about the~     decisions, and also assess decisional conflict, regret and distress. Study methods involve~     interviewing a total of 75 patients, their loved ones and oncologists about past cancer~     treatment decisions. Analysis will consist mainly of qualitative content analysis. The~     investigators do not anticipate risk or safety issues beyond loss of confidentiality or~     minimal discomfort while discussing a cancer treatment decision.~   "
88532|NCT01898468|"~     Post-thoracotomy Pain Syndrome (PTPS) is defined as pain that recurs or persists along a~     thoracotomy scar at least 2 months following surgery. PTPS presents a frustrating challenge~     to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing~     thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the~     compression of the intercostal nerves during routine closure. Closure of thoracotomies using~     intracostal sutures is a novel technique where sutures are passed through holes drilled into~     the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized~     control study involving 90 patients undergoing elective posterolateral thoracotomies.~     Participants will be randomly assigned to undergo thoracotomy closure with pericostal~     sutures or intracostal sutures. Our primary outcome will assess the incidence and severity~     of PTPS at 3, 6, and 12 months after surgery between groups.~   "
88533|NCT01898455|"~     This study will be looking at the clinical efficacy of using a intranasal evaporative~     cooling device in providing relief of the symptoms of migraine and cluster headache. It will~     involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it~     evaporates and removes heat from the tissue, thereby cooling the tissue and the blood~     vessels which supply blood to the brain. This cooling effect will cause the blood vessels to~     constrict and it is thought that this may provide symptomatic relief in both these forms of~     headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study~     and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be~     monitored during the treatment and for two hours afterwards to assess headache severity and~     side effects. There will be a further follow up 2 months after the last treatment to assess~     for longer term side effects from the treatment.~   "
88534|NCT01898442|"~     Ticagrelor is a reversible direct acting P2Y12 antagonist, which has shown to be superior to~     clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Ticagrelor is~     considered a first line therapy to be administered as soon as possible in ACS patients.~     However, the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are~     delayed in patients with STEMI undergoing primary PCI. The use of higher loading dose~     regimens of ticagrelor has therefore been advocated. The proposed investigation will have a~     prospective, randomized, parallel design in which STEMI patients undergoing primary PCI will~     be randomized to receive three different loading dose of ticagrelor (180 mg, 270 mg and 360~     mg). Pharmacodynamic testing will be performed at several time points to test our study~     hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet~     inhibitory effects.~   "
88535|NCT01898429|"~     In this pilot study, we propose to test whether high frequency stimulation of the~     subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD~     patients, to compare the effects of left-sided vs. right-sided stimulation, and to~     investigate potential mechanisms of action of this intervention. Importantly, this study~     will be used to assess the need for and assist in planning a larger, more definitive trial~     of SCC DBS for TRD.~   "
88536|NCT01898416|"~     The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral~     administration and subsequently intraoperative tumor bed phototherapy with red light laser,~     as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with~     desmoid tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence~     rate.~   "
88538|NCT01898390|"~     The Transeuro Transplant study is a trial which will involve grafting foetal tissue into the~     brain of patients with Parkinson's disease, who are already been followed in the~     observational study. The tissue inserted in the brain is to help replace and rebuild lost~     dopamine from the brain due to Parkinson's disease. Only 20 patients will be selected for~     the transplant.~   "
88539|NCT01898377|"~     In this study we will combine mycophenolate mofetil and imatinib mesylate to treat~     steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (GVHD) to see~     the response rate and to find the safety of combination.~   "
88540|NCT01898364|"~     Primary Objective:~      To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa~     treated late-onset Pompe disease patients.~      Secondary Objective:~      To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and~     alglucosidase alfa treated late-onset Pompe disease patients.~      To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and~     alglucosidase alfa treated late-onset Pompe disease patients.~   "
88541|NCT01898351|"~     Summary~      This research will examine the nutritional effects of supplementing diets with alternative~     plant sources of protein with potential to be grown in Scotland. In particular, we will~     assess the potential of these plant protein sources to complement diets in which the~     predominant source of protein is meat. These protein sources will include plants from the~     Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the~     development of new foods. The research will assess if these plant proteins can deliver a~     comparable alternative to meat based diets.~      It is anticipated that the results could encourage increased consumption of plant products~     which would be favorable for consumers shifting away from animal-derived proteins for health~     and/or environmental reasons.~      Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for~     partial replacement in predominantly meat based diets.~      Objective: The objective of this acute study is to assess satiety, postprandial effects,~     metabolite bioavailability and metabolism of single alternative proteins from a shortlist~     including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat.~      Study protocol~      Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with~     meat in healthy people on:~        -  Biomarkers of satiety as measured by gut-related hormones and subjective appetite using~          visual analogue scales, specifically to be collected during the meal over a three hour~          period, every 30 minutes. The energy intake measured for each volunteer after an ad~          libitum lunch (five hours after test meal).~        -  Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL),~          high density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA).~        -  Assessment of peripheral glycaemic control, fasting glucose, area under the curve~          combined with insulin data.~        -  Plasma and urine markers of important phytochemical and protein metabolites will be~          quantitatively analysed to determine the systemic availability, in vivo concentrations~          and excretion times.~        -  Volunteer views towards diets rich in plant proteins will be assessed.~   "
88542|NCT01898338|"~     To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin~     alone in the treatment of methicillin resistant Staphylococcus aureus (MRSA) bacteremia.~   "
88543|NCT01898325|"~     The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher~     disease divided into two groups, naive GD patients and GD patients treated with ERT. As~     liver biopsy in these patients not recommended because the risk of bleeding using Fibroscan~     is a safe with diagnostic accuracy regarding the liver (& Spleen) fibrosis. Estimating~     spleen fibrosis is an innovative approach in liver disease and Gaucher.~      The evaluation of fibrosis with this new and safe method could avoid complications~     antiinvasive procedure in GD patients. The addition of fibrosis biomarkers will help for~     patients score evaluation. The finding of liver and spleen stiffness will be evaluated in~     native and ERT treated Gaucher patients in order to assess ERT effect on fibrosis.~      The Aims are: 1) To assess liver and spleen stiffness measurement using fibroscan and~     evaluate liver and spleen fibrosis in patients with GD.~      2) To compare the elastography in two cohorts of GD patients: ERT treated and naïve GD~     patients and two control groups of patients: healthy and Non Alcoholic Steatohepatitis~     (NASH) patients.~      3) To correlate the elastography findings with clinical and laboratory data in the four~     patient groups focusing on Gaucher disease manifestations and GD severity. To compare the~     elastography in GD naïve and ERT treated patients.~   "
88544|NCT01898312|"~     Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a~     role in breast cell proliferation and the development of breast cancer. Here, the effect of~     a progesterone receptor modulator, mifepristone, on cell proliferation in human breast~     tissue in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results~     implicate a possible protective effect of mifepristone in breast epithelium. The ability of~     mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may~     also prove beneficial when used for contraceptive purposes and on other indications. The~     proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo~     treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer~     and ovarian cancer.~   "
88545|NCT01898299|"~     The purpose of the present research is to test a potential new treatment for auditory verbal~     hallucinations in schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a~     neurostimulation technique that passes an extremely weak electric current through the brain.~     During the treatment, two electrodes are positioned on the scalp above regions of the brain~     implicated in abnormal cortical activity associated with auditory verbal hallucinations in~     schizophrenia. Due to the directional flow of current, one electrode, termed~     cathodal,inhibits cortical activity, and the other, termed anodal, increases cortical~     activity. These electrodes will be placed such that cathodal stimulation is applied to an~     area associated with hyperactivity and anodal stimulation to an area associated with~     hypoactivity. One preliminary study has revealed that this form of neurostimulation can~     alleviate auditory verbal hallucination symptoms both immediately following five days of~     treatment and up to three months after the final treatment. The goal of this study is to~     replicate these effects and explore the mechanisms that may underpin them.~   "
88546|NCT01898286|"~     This is an extension study to evaluate the safety and tolerability of long-term treatment~     with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters~     of metabolic control and on preservation of beta-cell function in subjects who have long~     exposure to DiaPep277®.~   "
88547|NCT01898273|"~     The primary objective of this trial is to determine the optimal dose and imaging time~     point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used~     in future trials.~   "
88548|NCT01898260|"~     The purpose of this study is to compare the subjective performance of two daily disposable~     contact lenses with respect to comfort and handling.~   "
93699|NCT01830686|"~     The purpose of this study is to help understand the benefits of eating food supplemented~     with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is~     extracted) on glucose metabolism and body weight.~   "
88549|NCT01898247|"~     The goal of the proposed research is to investigate the use a medical simulation and mastery~     learning (where all learners must reach a high standard before completion of training)~     curriculum to improve internal medicine residents' skills when performing thoracentesis~     procedures (remove fluid from around the lung) on patients. Additionally, we will evaluate~     how these skills affect patient outcomes by comparing thoracenteses performed by~     simulator-trained residents to those who have traditional training. This project will~     evaluate these overall hypotheses: simulation-based training using the mastery learning~     approach improves medicine resident's thoracentesis skills and improves patient outcomes and~     satisfaction.~   "
88550|NCT01898234|"~     Background:~      High- and low-flux dialysis membranes made of different materials may correlate with various~     hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and~     incidence of hypotensive episodes by comparing some of the most commonly used high- and~     low-flux dialyzers.~      Methodology:~      The study was designed as an open label, randomized, cross-over investigation, including 25~     patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A~     (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone~     low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed~     with a non-invasive technique and patients were asked to provide tolerance feedback through~     a questionnaire.~   "
88551|NCT01898221|"~     The broad, long-term objective of this project is to evaluate the therapeutic value of vein~     of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation~     (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of~     stroke, disability and increased mortality. Catheter ablation - pulmonary vein (PV) antral~     isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic~     beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in~     persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic~     cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include~     greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to~     increases in procedural complexity and duration, need of repeat procedures, and~     complications such as atrial flutters, particularly perimitral flutter (PMF). The~     investigators have developed a technique to perform rapid ablation of atrial tissues in AF~     using ethanol infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid~     and safe tissue ablation of LA tissue neighboring the LA ridge and left inferior PV; 2)~     Regional LA vagal denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation~     of cure of PMF by ablating most of the mitral isthmus.~      The investigators propose to evaluate outcomes differences yielded by VOM ethanol when added~     to conventional PVAI. The specific aims are: #1.To assesses the impact of VOM ethanol~     infusion in procedure success when added to de novo catheter ablation of persistent AF. The~     investigators will randomize patients with persistent AF undergoing a first AF ablation to~     standard PVAI vs. a combined VOM ethanol infusion plus PVAI (VOM-PV) #2. To assess the~     impact of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a~     failed ablation. Patients undergoing a repeat procedure for persistent AF after a failed~     PVAI will be randomized to either PVAI or VOM-PV as their repeat procedure. End points will~     include freedom from symptomatic or electrocardiographic AF after 12-15 months.~   "
88552|NCT01898208|"~     Would rapid identification of bacteria and rapid detection of methicillin-resistant S.~     aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in~     positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead~     to increased cost)?~   "
88553|NCT01898195|"~     Smoking rates among individuals living with HIV/AIDS range between 47% and 65%, a prevalence~     that is roughly three times the rate of the general population. This elevated prevalence is~     alarming given the increased likelihood of numerous adverse health outcomes experienced by~     HIV-positive smokers. Cigarette smoking is associated with greater levels of HIV-related~     symptom burden and appears to decrease the effectiveness of HAART as assessed by both viral~     load and CD4 counts (Vidrine 2009, Marshall 2009, Vidrine 2007, Miguez-Burbane 2005). PLWHA~     who smoke are also at increased risk of infections and noninfectious pulmonary complications~     and both AIDS-associated and non-AIDS-associated malignancies compared to nonsmokers. This~     study will refine and pilot test a theory-driven smoking cessation intervention that~     enhances existing behavioral approaches by testing the impact of text message reminders to~     take varenicline and the feasibility and additional impact of including adherence-focused~     behavioral cessation counseling. The investigators propose to randomize 190 participants,~     recruited from three HIV/AIDS clinic, to a three arm pilot study that compares: 1) Standard~     Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell~     phone-delivered adherence-focused behavioral therapy (ABT). Participants in all three arms~     will receive varenicline for 12 weeks. The primary outcomes are adherence to varenicline and~     biochemically validated smoking abstinence at 12 weeks and 3-month follow-up from the time~     of study enrollment.~   "
88554|NCT01898182|"~     The purpose of the study is to evaluate the change in the severity and clinical signs of~     skin photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will~     recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines~     for a period of 3 months (12 weeks). Changes in severity will be documented using physician~     evaluation, self-evaluation, and through VISIA complexion analysis system.~   "
88555|NCT01898169|"~     Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes~     have gained in popularity over the last several years. The technology used to manufacture~     ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content,~     e-liquids and flavorings. Only in the last few years have researchers begun to examine the~     health risks and benefits, nicotine blood levels, patterns of use, likability, and craving~     and withdrawal relief of ENDS. These studies have shown great variability in nicotine~     delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS~     brands among tobacco cigarette smokers.~      This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is~     a single use unit that resembles a traditional cigarette and delivers approximately 150~     puffs. The cartridge inside contains 26 milligrams of nicotine.~      Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on~     heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes~     and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns~     for cigarettes and NJOY King ENDS during a one-week period in which they can use each~     freely.~      The study includes three visits to the clinic spaced approximately one week apart. Subjects~     who pass the screening visit will return to the clinic for Visit 2 in which they will sample~     the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one~     week later. They will be instructed to use as many or as few as they like during the week.~     Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of~     e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of~     abstinence from any form of nicotine in order to assure that they have no nicotine left in~     their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY~     Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be~     measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4)~     craving for cigarettes and nicotine withdrawal symptoms will be assessed.~   "
88556|NCT01898156|"~     This Phase 1/2 study is designed to assess the following: safety and tolerability of~     BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2~     Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and~     preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.~   "
88557|NCT01898143|"~     Whole body vibration training seems to be a useful adjunct in exercise training in patients~     with severe COPD. The basic principle relies on reflectory muscle contractions caused by a~     vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary~     parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary~     parameters during whole body vibration training in patients with chronic lung disease.~   "
88558|NCT01898130|"~     This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease~     has spread to their brain. This study will not evaluate the effect of bevacizumab on the~     systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab~     may interfere with the growth of new blood vessels; therefore it might stop tumor growth and~     possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the~     blood vessels.~   "
88559|NCT01898117|"~     Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor~     survival. TNBC can be divided into at least two molecular entities; BRCA-like and~     non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup~     exists within TNBCs that derives a benefit from bevacizumab added to first line~     chemotherapy.~   "
88560|NCT01898104|"~     The purpose of this study is to first determine the maximum tolerated dose of capecitabine~     given alone or in combination with valproic acid during preoperative short-course~     radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the~     addition of valproic acid or the addition of capecitabine to short-course radiotherapy,~     before optimal radical surgery might increase the pathologic complete tumor regression rate~     in patients with low-moderate risk rectal cancer.~   "
88561|NCT01898091|"~     This study involves adults receiving radiation therapy for head and neck cancer and will~     test whether or not the study mouthrinse may lessen oral mucositis.~   "
88562|NCT01898078|"~     This is an open-label, multicenter, phase 1 study with the primary objective of evaluating~     the effect of food on the single-dose PK properties of alisertib administered as the ECT~     formulation. The secondary objective is to further evaluate the safety and tolerability of~     alisertib.~   "
88563|NCT01898065|"~     With functional imaging development, it becomes possible to increase radiation dose to~     radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This~     strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role~     in the resistance of these tumors to radiation.~      In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we~     should characterize changes in hypoxia before treatment and during radiotherapy.~        -  If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by~          an integrated boost is performed.~        -  If hypoxia varied (increasing or incomplete regression), a final boost strategy of~          radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a~          first fractionated IMRT could be considered.~      This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available~     tool to physicians in assessing tumor hypoxia.~   "
88564|NCT01898052|"~     The purpose of this study is to determine the periarticular multimodal drug injection has~     more efficacy for controlling pain after TKA than single anaesthetic drug injection.~   "
88565|NCT01898039|"~     This study is designed for patients who had malignant melanoma and, following tumor removal,~     are now free of disease, or have only very minor residual disease, and are at a very high~     risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma~     vaccine, a compatible melanoma cell line that has been engineered to express a molecule~     termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's~     immune system, and to induce its stimulation. The hypothesis that drives the study states~     that the immune response against the cell line will also be effective against the residual~     tumor that may still be present in the body.~   "
88566|NCT01898026|"~     The proposed study will examine the effects of incorporating a soluble fibre blend into~     commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood~     glucose. A sensory evaluation will be conducted in phase I to asses for differences between~     the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot~     breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of~     the 8 test foods from phase I.~   "
88567|NCT01898013|"~     The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to~     determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The~     total study duration is 6 weeks (followed by two-follow up phone calls). All patients will~     monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only~     lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these~     subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4~     weeks. Patient interview assessments and laboratory studies will be performed at each~     interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites will~     be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high~     performance liquid chromatography (HPLC).~   "
88568|NCT01898000|"~     The present study was a randomized control clinical trial, which included 90 subjects with~     chronic generalised gingivitis of age group 25-40 years, reporting to outpatient department~     of Periodontics, Government Dental College & Research Institute, Bangalore form January 2013~     to April 2013. The research protocol was initially submitted and approved by the~     Institutional Ethical Committee and Review Board of the Government Dental College and~     Research Institute, Bangalore. After ethical approval, all subjects were verbally informed~     and written signed informed consent was taken for participation in the study.~      Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into~     three groups: Group I: Placebo mouthwash, Group II: Triphala (TRP) mouthwash, Group III:~     Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The~     plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and~     microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days~     respectively.~      TRP mouthwash was found to decrease the inflammatory parameters. As improvement in~     gingivitis was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a~     potential therapeutic agent in treatment of gingivitis.~   "
93711|NCT01830530|"~     This study is aimed to assess the efficacy of combined treatment with two antihypertensive~     agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high~     altitude.~   "
88569|NCT01897987|"~     This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM®~     versus placebo, for the treatment of BPD in premature infants. Subjects who participated in~     and completed the initial stage of the Phase II trial (NCT01297205 ) will be followed-up~     until 60 months of corrected age.~   "
88570|NCT01897974|"~     Children with seizure disorder face unique challenges during the perioperative period.~     Fasting, sleep-deprivation, and missed doses of medications while patients are required to~     have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The~     incidence of seizures in this population is unknown but correlated with patient's underlying~     condition and missed doses of anti-convulsant. Previous work has determined this is not a~     unique problem.~      The investigators initially found compliance extremely poor at 60%. The investigators have~     made improvement to about 80% compliance through various interventions: education of~     nursing, availability of anticonvulsant intravenous dosing alternatives, and re-wording the~     hospital NPO policy. The investigators feel that a new, more focused, survey will help~     identify, perioperative reasons for non-compliance on part of the parents. This information~     will be utilized to guide further interventions aimed at improving compliance.~   "
88571|NCT01897961|"~     The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique~     at the adult and represent approximately 2 % of the causes of terminal chronic renal~     insufficiency. A etiology balance assessment must be systematically realized to eliminate a~     secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by~     type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary~     GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this~     receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects~     of idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize~     PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during~     the stake in forgiveness of the disease.~      Some cases of second offense of GEM idiopathique after renal transplantation presenting~     antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems~     parallel to the increase of a proteinurie in touch with a second offense of GEM, and~     antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to~     obtain a forgiveness.~      A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on~     the native loins. The physiopathology of this affection remains unknown.~      Working hypothesis and objectives We shall look in which proportion the presence of antibody~     anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal~     transplantation. We anticipate that the GEM of novo of the renal transplant answers a~     different physiopathology, and will not be associated with the presence of antibody~     anti-PLA2R1. We hope to demonstrate that at the expanding patients of antibody anti-PLA2R1,~     the title of these antibodies is correlated in the activity of the disease and in the renal~     survival, and that the longitudinal follow-up of the title of these antibodies has an~     interest forecast and therapeutics.~   "
88572|NCT01897948|"~     This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate~     the relation to cognitive outcomes.~   "
88573|NCT01897935|"~     This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM).~     Patients meeting the inclusion/exclusion criteria will receive a standard eye examination~     including a slit lamp examination to collect ocular flare data. In addition to the standard~     eye examination, subjects will receive flare measurements using the OFAM device.~   "
88574|NCT01897922|"~     This clinical trial will evaluate an investigational infant formula with a probiotic to~     determine if it provides normal growth and if it is well tolerated by term infants compared~     to a marketed routine infant formula.~   "
88575|NCT01897909|"~     The main objective of the study is to investigate the impact of H. pylori infection on~     immune activation and clinical outcome in HIV patients.~      Other specific study objectives are:~        1. To investigate the effects of H. pylori infection on immune activation and the T-cell~          profile in HIV positive patients and compare those with HIV negative controls.~        2. To assess the influence of H. pylori infection on virological and immune parameters,~          and on clinical progression of HIV infection (WHO stage, opportunistic infections).~        3. To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye~          Teaching Hospital.~        4. To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.~        5. To assess the association of H. pylori infection with gastrointestinal symptoms and~          pathology in HIV patients.~        6. To compare the clinical and immunological response to antiretroviral therapy and in~          HIV-patients with and without concomitant H. pylori infection.~   "
88576|NCT01897896|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and~     tolerability of long term treatment with SD-809 ER will be assessed in Switch subjects as~     well as Rollover subjects completing a randomized, double blind, placebo controlled study~     of SD-809 ER,~   "
88577|NCT01897883|"~     The purpose of this study is to provide current and reliable data of dyslipidimia management~     together with control situation of blood pressure and glucose for post-stroke patients~     within 6-12 months from attack, and also the association between patient characteristics and~     control rate of lipids in this population.~      It is an non-interventional study, no study specified treatment is required.Approximately~     5000 post ischemic stroke patients within 6-12 months from attack will enter into the study.~     Fifty centres from different regions of China will participate in this study.~   "
88578|NCT01897870|"~     the purpose of this study is to determine the the effect of a home-based medication~     management program on drug-related problems post-discharge.~   "
88579|NCT01897857|"~     In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is~     commonly performed for continuous monitoring of systemic blood pressure and intermittent~     assessment of arterial blood gases. The radial artery is the preferred artery, because of~     its well-documented low complication rate and easy access, but, radial artery cannulation is~     may associated with complications. Atherosclerosis is a systemic phenomenon, and structural~     changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and~     reduction in distensibility occur frequently throughout the arterial tree. Especially in~     patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and~     perhaps calcification. In a recent study, it was found that the radial artery flow was~     decreased immediately after cannulation, but recovered to its pre-cannulation value after~     5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately~     after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical~     status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory~     increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis,~     particularly in patients with DM. In our study, we found whether there is appropriate~     compensatory increase of blood flow in the ulnar artery after the radial artery cannulation~     in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing~     elective kidney transplantation.~   "
88580|NCT01897844|"~     The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as~     double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14~     consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label,~     continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to~     9000 mcg/day of ITF2984.~   "
88581|NCT01897831|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of~     respiratory and urinary tract acute bacterial infection under the widely used in clinical~     conditions.~   "
88582|NCT01897818|"~     ALS is a severe progressive neurodegenerative disease characterized by degeneration motor~     neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all~     motor skills as well as the possibility of communication written and oral developing a state~     close Locked In Syndrome (LIS). The main objective is to establish the feasibility of~     brain-computer interface using the pathological condition, with dependent disabled subjects~     as a means of communication.~   "
88583|NCT01897805|"~     Title:~      A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of~     of Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary~     artery disease~      Objective:~      To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on~     clinical outcomes in patients with chronic stable coronary artery disease~      The study hypothesis:~      The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial~     infarction, nonfatal stroke in the treatment group is the same as that in control group.~      The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal~     myocardial infarction, nonfatal stroke in the treatment group is different from that in~     control group.~      Sample size:~      2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.~      Number of sites: 99 sites in China~      Study drugs:~      Heart-protecting Musk Pill and the matching placebo pills.~      Design:~      A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be~     randomized to treatment group and placebo group after screening and get corresponding~     treatment as follow.~      Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk~     Pills each time, three times a day by mouth for 24 months.~      Control group: Standard treatment for coronary artery disease plus 2 placebo pills each~     time, three times a day by mouth for 24 months.~      Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization.~     During follow-up period, patients could undertake PCI or CABG if angina get out of control~     or evidence of ischemia aggravated is found.~   "
88584|NCT01897792|"~     The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and~     E) on the development of coagulation derangements and nosocomial pneumonia after severe~     trauma in patients.~   "
88585|NCT01897779|"~     RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem~     (RPX2014) to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
88586|NCT01897766|"~     The objective of this surveillance is to collect Safety and Effectiveness information for~     Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).~   "
88587|NCT01897753|"~     The purpose of this protocol is to retrospectively study the influence of age at start of~     growth hormone (GH) treatment on height gain in children born small for gestational age~     (SGA).~   "
88588|NCT01897740|"~     The purpose of this study is to provide Sildenafil therapy for subjects who completed~     A1481156 study and are judged by the investigator to derive clinical benefit from continued~     treatment with Sildenafil, prior to reimbursement and availability for subjects in the~     Russian Federation.~   "
88589|NCT01897727|"~     Hypertension affects an estimated 60-70 million Americans, predisposing them to potentially~     life threatening cardiovascular complications. Resistant hypertension, defined as~     uncontrolled blood pressure on 3 or more different antihypertensive agents, is common,~     affecting 15-20% of the entire hypertensive population or an estimated 12-14 million~     Americans. Although associated with obesity, increasing age, black race, and chronic kidney~     disease, mechanisms of treatment resistance remain obscure. The investigators' laboratory~     identified primary aldosteronism (PA) as a common cause of treatment resistance with a~     prevalence of 20% among subjects with resistant hypertension. This is clinically important~     because recognition of PA can lead to effective treatment with use of aldosterone blockers.~     Obstructive sleep apnea (OSA) is strongly associated with and predicts development of~     hypertension as demonstrated in landmark cohort studies including the Sleep Heart Health~     Study and the Wisconsin Sleep Cohort Study.~      The investigators' laboratory has confirmed OSA to be extremely common in subjects with~     resistant hypertension, with a prevalence of approximately 85%. Recognizing that PA and OSA~     are exceptionally common in subjects with resistant hypertension, the investigators~     hypothesized that the 2 may be causally related. In testing this hypothesis, the~     investigators recently reported that plasma aldosterone levels are positively correlated~     with OSA severity in subjects with resistant hypertension but not in normotensive control~     subjects. This observation suggests that there is an important mechanistic interaction~     between untreated OSA and aldosterone excess in subjects with resistant hypertension. While~     the investigators' original hypothesis was that OSA stimulates aldosterone release, the~     investigators recognize that the opposite may also be true; that is, aldosterone excess in~     subjects with resistant hypertension worsens OSA. Distinguishing between these two~     possibilities has potentially far-reaching clinical implications. If the former hypothesis~     is true, effective treatment of OSA would be expected to suppress aldosterone release in~     subjects with resistant hypertension, thereby reversing the underlying cause of their~     treatment resistance. If the latter hypothesis is true, use of mineralocorticoid receptor~     antagonists would be expected to reduce OSA severity in subjects with resistant~     hypertension, thereby enhancing treatment of OSA. Either scenario would represent a new~     treatment approach for a highly prevalent and serious medical problem.~   "
88590|NCT01897714|"~     The study will explore escalating doses of melflufen in combination with dexamethasone in~     small groups of patients to find the maximum tolerated dose of melflufen. That dose will~     then be used to determine the efficacy and safety profile of melflufen in combination with~     dexamethasone in a larger group of patients.~   "
88591|NCT01897701|"~     This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old.~     Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior~     influenza immunization within the past three months. Proportions of subjects in the various~     strata will not be pre-specified; rather, the goal will be to achieve an approximately equal~     distribution of subjects with these characteristics across the various treatment groups.~      Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in~     alternate deltoids. For each subject, study follow-up will span approximately 385 days~     total, or approximately 13 months from the first dose.~   "
88592|NCT01897688|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta~     cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with~     immunosuppressive medications, specifically using Campath as induction, for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
88593|NCT01897675|"~     Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are~     frequently are packed or stented open with the presence of a wick, and traditional care~     requires re-visits every 2-3 days to have the packing removed and replaced, until finally~     the abscess cavity has closed, usually 1-2 weeks after initial presentation.~      Recently there have been attempts to employ less invasive techniques for abscess management.~     One novel technique, loop drainage, has been reported in case reports/case series for~     management of a variety of types of abscesses in the surgical subspecialty literature.~      We propose to conduct a randomized prospective study comparing the efficacy of the loop~     drainage technique with the traditional incision and drainage technique of abscess~     management.~      Patients presenting to the main or urgent care areas of the Emergency Department at Boston~     Medical Center for treatment of an abscess will be considered for enrollment as potential~     subjects. After the treating clinician identifies the patient as an appropriate subject, a~     Research Associate (RA) will approach the patient and obtain written informed consent to~     enroll in the study. The subject will then be randomized to the management arm of either~     loop drainage or traditional I&D. The clinician will fill out a data sheet describing the~     abscess characteristics, and then perform either loop drainage or incision and drainage,~     depending on randomization and the subject will fill out a satisfaction survey. Fourteen~     days after initial visit, subjects will return for follow-up. The subject will fill out a~     satisfaction survey, and a study investigator blinded to the treatment group will assess the~     subject for abscess resolution, cosmetic outcome, number of follow-up visits, and~     complications.~      The study investigators will then compare outcomes between the two study groups.~   "
88594|NCT01897662|"~     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat~     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is~     soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches~     the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007,~     considers that this ingredient is a soluble dietary fiber. Recent work in China in~     overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and~     demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced~     food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the~     possible mechanisms of action, are the metabolites produced by colonic fermentation of~     NUTRIOSE.~      The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE~     FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance~     in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is~     proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on~     satiety and satiation and changes in colonic flora and its metabolites.~   "
88595|NCT01897649|"~     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat~     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is~     soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches~     the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007,~     considers that this ingredient is a soluble dietary fiber. The objective of this research~     is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut~     microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes~     will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a~     questionnaire by volunteers.~   "
88596|NCT01897636|"~     Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall~     survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches~     are typically not curative and provide only minor increases in survivals in most cases.~     Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role~     in the initiation, programming, and regulation of tumor-specific immune responses. Isolated~     DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found~     to induce protective and therapeutic anti-tumor immunity in experimental animals. Some~     clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor~     immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established~     technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided~     fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a~     promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy~     and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into~     advanced pancreatic cancer~   "
88597|NCT01897623|"~     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms~     (AAA) among male patients with coronary artery disease (CAD) verified in coronary~     angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases~     (coronary artery disease, peripheral artery disease and carotid artery disease), so the~     hypothesis is that AAA should be more common among these CAD patients, thus making screening~     of these patients (for AAA) more cost-efficient.~      Study will be carried out as a multi-center prospective screening study. Data will be~     collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere~     University Hospital. Data consists of 200 consecutive coronary angiography patients in each~     hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be~     recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with~     previously known AAA will be excluded from the study.~   "
88598|NCT01897610|"~     Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Nexavar~     to advanced Hepatocellular carcinoma patients when compared with the control group who did~     not receive administration of the drug.~   "
88599|NCT01897597|"~     The purpose of this trial is to investigate the relative bioavailability of a BI 144807~     tablet formulation compared to the oral solution formulation after single dose~     administration (intermediate and high dose) under fasted conditions. Further objectives are~     to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807~     administered as tablet, and to compare the relative bioavailability of two different tablet~     formulations.~   "
88600|NCT01897584|"~     Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial~     oxygenation and respiratory mechanics~   "
88601|NCT01897571|"~     This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The~     Phase 1 portion (closed to accrual as of January 25, 2016) comprises dose escalation and~     establishment of the recommended Phase 2 dose (RP2D) when EPZ-6438 (E7438) is given BID~     (twice daily) orally on a continuous basis. Additionally, in separate cohorts in Phase 1,~     the effect of food on the bioavailability of EPZ-6438 as well as the drug-drug interaction~     (DDI) potential of EPZ-6438 are being evaluated. The Phase 2 part was initiated after~     determining the RP2D. Phase 2 enrolls subjects with DLBCL and FL for the determination of~     efficacy and safety of EPZ-6438 in 5 separate cohorts determined by centrally confirmed~     histology, cell of origin (COO), and EZH2 mutation status.~   "
88602|NCT01897558|"~     Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw~     (active fixation) for initial fixation in the patient´s heart. Both types of electrodes~     provide similar results in a long-term follow-up and the use of one or the other electrode~     type in many instances is mainly based on the implanter´s preference. The PACMAN-trial~     investigates whether the two lead types are associated with different amounts of myocardial~     micro-damage during implantation.~   "
88603|NCT01897545|"~     The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)~     lowering, atrial fibrillation (AF) recurrence and clinical data in patients with~     paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation~     alone or combined with percutaneous renal denervation.~   "
88604|NCT01897532|"~     The aim of the study is to investigate the longterm impact on cardiovascular morbidity,~     mortality and renal function of treatment with linagliptin in a selected population of~     patients with T2DM and to compare outcomes against placebo, on a background of standard of~     care.~   "
88605|NCT01897519|"~     This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk~     major surgery.~   "
88606|NCT01897506|"~     Our central hypothesis is that dietary limitations introduced by food allergy will~     contribute to increased food insecurity in households with food allergic children when~     compared to food insecure households without food allergic children.~   "
88607|NCT01897493|"~     The main purpose of this study is to determine how much digoxin gets into the blood stream~     and how long it takes the body to get rid of it when given with the study drug evacetrapib.~     This study will also look at the effect of evacetrapib on the removal of digoxin from the~     body by the kidneys. Information about any side effects that may occur will be collected.~     This study will last approximately 33 days for each participant, not including screening.~   "
88608|NCT01897480|"~     The primary purpose of this study is to compare the efficacy of the study drug LY2875358,~     given together with erlotinib, against erlotinib, alone. Participants will have Non-Small~     Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been~     treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib~     alone, for approximately 8 weeks. Participants with radiographic disease control at the end~     of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus~     erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may~     cross over to the combination treatment at the time of progression.~   "
88609|NCT01897467|"~     Losses of muscular fitness/balance are common occurrences with aging that can lead to an~     increased fall-risk. The accelerated bone loss that may accompany menopause makes some women~     even more at-risk for serious consequences related to falling. Interventions to reduce~     fall-risk have been conducted in an attempt to improve balance or muscular fitness, but~     often these interventions require monotonous exercises that don't arouse enough long-term~     interest to elicit the improvements. In other words, while the intervention may be~     beneficial, participants quit before they can realize any gains.~      Currently, there is little research that uses novel technology-based programs to promote~     balance exercises among middle-aged women. The Wii Fit system includes various strength and~     balance exercises integrated into games intended to have the participant have fun and retain~     interest, while also improving fitness. By using such a program, women could potentially~     improve their balance and decrease their fall risk in a way that is fun and exciting.~      The purpose of this study is to investigate the effect of a Wii Fit based exercise program~     on balance/muscular fitness/markers of bone health in women between the ages of 45-60 with~     low bone mass. Volunteers who have moderately low bone levels (n = 28) will be randomly~     assigned to either the Wii Fit exercise intervention or a normally active control. Balance~     ability, muscular fitness, body composition, physical activity levels and markers of bone~     health will be assessed before and after the intervention.~      Each participant in the intervention will be provided a pre-programmed Wii Fit console and~     balance board to use at home. The intervention will consist of a 12-week program that they~     perform 30 minutes a day 3 days a week. The exercises include 10 minutes of Yoga poses and~     strength exercises and then 20 minutes of balance games such as soccer heading, ski slalom~     and table tilt.~      At the 6 week point and the conclusion of the intervention, participants will come to the~     lab for testing on the same tests done initially.~      The overall goal of this study is to gauge the efficacy of this intervention to improve~     balance, fitness, and bone health in at-risk women. This project is important because it~     offers an exciting, fun, and motivating way to impact fall-risk before clinical symptoms~     develop. Overall, this intervention could significantly reduce healthcare dollars spent on~     fall-related outcomes, as well as reduce fall-related mortality.~   "
88610|NCT01897454|"~     This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride,~     and radiation therapy before surgery works in treating patients with pancreatic cancer that~     has not spread to other places in the body and can be removed by surgery. Drugs used in~     chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride,~     oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil,~     irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving combination~     chemotherapy and gemcitabine hydrochloride with radiation therapy before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
88611|NCT01897441|"~     This randomized pilot clinical trial studies chemotherapy before surgery and tissue sample~     collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such~     as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of~     tumor cells o grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide,~     paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of~     tissue from patients with breast cancer to study in the laboratory may help doctors learn~     more about how well patients will respond to treatment.~   "
88612|NCT01897428|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly~     developed bepotastine formulation, bepotastine salicylate, with a conventional formulation,~     bepotastine besilate, in healthy subjects with a single dose, randomized, open-label,~     2-sequence -2period crossover study.~   "
88613|NCT01897415|"~     This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For~     subject safety, the preceding subject must have completed one cycle of therapy (28 days)~     before the next subject can be treated. Subjects will be treated with i.v. administration of~     1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks.~   "
88625|NCT01897259|"~     This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be~     randomized into one of 4 possible treatments. The purpose is to individually examine the~     efficacy of each treatment, and determine if one treatment method is more effective than~     another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs~     (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.~   "
88614|NCT01897402|"~     The purpose of this study is to evaluate the production of antibodies to a new conjugate~     vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the~     production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135)~     polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also~     evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed~     vaccine. The hypothesis is that the test vaccine is comparable to the licensed active~     control vaccine.~   "
88615|NCT01897389|"~     The purpose of this study is to evaluate the relative bioavailability of 4 new formulations~     of abiraterone acetate compared to the current commercial formulation.~   "
88616|NCT01897376|"~     The purpose of this study is to determine if there is a difference between Pfannenstiel and~     midline vertical skin incision at time of cesarean section in preventing wound complications~     in the morbidly obese patient. This is a comparative effectiveness study of two~     commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical~     patients upon admission and randomize them to one of the above incision types in the~     operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound~     complications. There is minimal risk to the participant as both incision types are~     acceptable in current obstetrical practice. There is no direct benefit to the patient.~      Currently, there is no level I evidence to support either Pfannenstiel or midline vertical~     skin incision in the prevention of wound complications in the obese patient undergoing~     cesarean section. Therefore, current practice is for the surgeon to make the decision based~     on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean~     section is a very common procedure, with a national rate of 32% of all live births in 2007.~     Not only does obesity increase the expectant mother's risk of a cesarean section, it is also~     a well recognized risk factor for wound complication. The cesarean wound complication rate~     in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann~     Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight~     population, 28% compared to 1.4%. Results from this study could be extrapolated in the~     future to affect lower post-operative morbidity, higher patient satisfaction, less~     antibiotic use, shorter hospital stay, and overall lower health care costs.~   "
88617|NCT01897363|"~     This project will study whether infants with Prader-Willi Syndrome experience low blood~     sugars after short periods of fasting. This study will also evaluate metabolic markers in~     the blood to determine if infants with Prader-Willi Syndrome process energy differently than~     other children during fasting.~   "
88618|NCT01897350|"~     Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain~     functional and anatomical information on the heart. Several CMR parameters measured after~     primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value~     and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema~     is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated~     as the myocardial oedema minus infarct size; this again is a prognostic indicator following~     STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences~     available, with no standardisation of sequences used to assess this surrogate endpoint. The~     investigators propose to conduct a study to measure the myocardial oedema by all available~     techniques to determine the agreement between these methods.~   "
88619|NCT01897337|"~     PONV (Postoperative nausea and vomiting) is one of most common complications after general~     anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile~     agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as~     risk factors for developing PONV. In consequence, patients undergoing laparoscopic~     gynecologic surgery are at high risk for developing PONV. Most of these patients use~     fentanyl based IV-PCA. And it also causes PONV.~      So, we should prevent PONV in these patients by using multimodal or combination therapy.~      Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced~     nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.~      In this study, we investigate the effect of combining aprepitant with ondansetron in~     high-risk patients for PONV.~   "
88620|NCT01897324|"~     in this study, we are trying to monitor the effect of the addition of growth hormone on the~     different down regulation protocols ( long, short, antagonist and microflare). The outcome~     will be primarily assessed by the clinical pregnancy rates.~   "
88621|NCT01897311|"~     The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve~     stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean~     section.~   "
88622|NCT01897298|"~     This project plans on a training intervention by using public spaces and urban walkable~     trails, adapted to each patient needs and capabilities. Primary objective is to assess 12~     months effectiveness of the intervention with respect to: (primary outcome): physical~     activity level, and (secondary outcomes): COPD admissions, exercise capacity, body~     composition, quality of life, and mental health.~   "
88623|NCT01897285|"~     AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a~     waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone~     adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a~     non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in~     2012. A new source of silicone adhesive is now under assessment for this product. This~     Healthy Volunteer Wear test will form part of the Design Validation for this change in~     supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can~     coat the silicone adhesive to provide comparable adhesive dressing performance in terms of~     wear time, ease of use and with a similar safety profile in relation to the skin.~   "
88624|NCT01897272|"~     This research study is for patients who are schedule to have carpal tunnel release surgery.~     The investigators have developed this study in order to determine if post-operative~     splinting is effective in improvement of patient outcomes after this surgical procedure. The~     study is being conducted under the direction of Huey Tien, MD. The purpose of this study is~     to determine if post-operative splinting is effective in improving patient outcomes after~     having short-incision carpal tunnel release. The investigators will randomize each patient~     into group 1, splinting after surgery or group 2 no splinting after surgery. Each group will~     have the same outcome measurements done to determine the best outcome of the two groups.~   "
88627|NCT01897233|"~     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the~     pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in~     subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic~     fibrosis transmembrane conductance regulator (CFTR) gene.~   "
88628|NCT01897220|"~     The aim of the study is to analyze the present use of antithrombotic therapy on a large~     cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the~     medication was discontinued, if any other antithrombotic therapy was used in the~     perioperative period and prevalence of perioperative complications - especially ischemic or~     bleeding. These complications will be correlated with the pattern of antithrombotic therapy~     administration. Working hypothesis is to obtain a large database of unselected cohort of~     consecutive patients for mapping of this practically important, but in the evidence-based~     medicine, still neglected problem.~   "
88629|NCT01897207|"~     The main aim of this trial is to assess the response rate, the feasibility and toxicity of~     the treatment with antigen loaded Dendritic Cell Vaccination in Prostate Cancer patients.~     Furthermore we want to investigate biological responses by measuring markers of in-vivo and~     ex-vivo immunomodulation.~   "
88630|NCT01897194|"~     Despite its clinical significance, the pathophysiology of coma is still under investigation~     and the physiology of emergence from coma remains a mystery. Furthermore, predictors of~     emergence from coma, despite their obvious clinical value, remain un-established. Because of~     its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has~     been studied as both an animal and human model of coma, and awakening from sleep has~     likewise been studied as a surrogate of coma emergence. In this study, we will determine~     whether certain electrographic patterns, known as spectral shifts, which have correlates in~     normal sleep, are predictive of eventual awakening from coma and the time course of this~     emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed~     for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a~     small device that can be easily and properly positioned on the head by hospital personnel~     and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires~     placement of up to 25 wires, which can impede efficient intensive patient care. Our~     hypothesis is that we can detect a difference in spectral shifts in comatose patients who~     will eventually emerge from coma as compared to comatose patients who do not wake up and~     that a wireless EEG patch-type device can effectively make this distinction.~   "
88631|NCT01897181|"~     The purpose of this study is to evaluate the central auditory processing in patients with~     bilateral sensorineural hearing loss and to observe the change of the central auditory~     processing ability after using hearing aids.~   "
88632|NCT01897168|"~     The primary purpose of this study is to determine the effects of early diet on bone health.~   "
88633|NCT01897155|"~     The purpose of this randomized clinical trial is to evaluate the effect of acute arterial~     hypertension maintained during surgery on morphine's requirements in patients undergoing~     laparoscopic cholecystectomy~   "
88634|NCT01897142|"~     The purpose of this study is to determine what the study drug does to the body, what the~     body does to the study drug, and if the study drug is safe and well tolerated when given to~     adult healthy volunteers.~   "
88635|NCT01897129|"~     Purpose Our study involves two hypotheses. One is that genital infection with HPV is~     associated with increased risk of miscarriage and preterm birth. The second hypothesis is~     that human papillomavirus can ascend from the vagina to the uterus through the cervix and~     cross the placental barrier. We wish to verify these hypotheses in our studies.~      This study will determine the prevalence of HPV in Danish pregnant women and examine HPV's~     role in the aetiology of spontaneous abortion and preterm birth.~   "
88636|NCT01897116|"~     This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of~     BRAF V600E+ metastatic melanoma.~   "
88637|NCT01897103|"~     The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers~     during the perioperative period. The goal is to develop a clinically useful assessment of~     platelet/coagulation activity for risk stratification that may ultimately serve as a target~     for therapeutic intervention. This study will enroll 200 patients with peripheral artery~     disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is~     scheduled to begin enrollment in July 2013 for approximately two years.~   "
88638|NCT01897090|"~     A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of~     Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's~     Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at~     Johns Hopkins University. Patients agree not to be on any other major treatments, with the~     exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications~     during the course of the study and will obtain their physician's permission.They will be~     divided into a treatment and standard diet group: thirty (30) patients will be on the~     Crohn's Disease Diet (primarily an anti-inflammatory diet that is an elimination diet -~     gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be~     given the Dietary Guideline recommendations and similar dietary counseling attention. To~     assess the clinical efficacy and tolerance of the trial population, patients will be~     monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit~     (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the~     study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease~     Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe =~     450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr,~     female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: <10pg/ml)/, Overall Quality of~     Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom~     Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL)~     Questionnaire, and health care costs measured by a health care cost questionnaire.~   "
88639|NCT01897077|"~     The purpose of this study is to determine if a new method of administration of peanut~     sublingual immunotherapy, a dissolving peanut film, is effective.~   "
88882|NCT01893866|"~     The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg~     pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant~     administered as two separate 1 mL injections and to characterize the pharmacokinetics of the~     new 30 mg strength.~   "
88640|NCT01897064|"~     The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and~     neurocognitive functioning including memory, attention, the ability to plan activities, and~     learn new information. Participants will be assigned by chance to receive regular care or~     exercise sessions in addition to regular care. This study will allow determining the~     potential positive influence of AE on cognitive and daily functioning in individuals with~     schizophrenia.~   "
88641|NCT01897051|"~     To reduce portal pressure, the only recommended medication is nonselective beta~     blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor~     response rate and compliance.~      Recent literature has supported the role of bacterial translocation as a mediator of~     splanchnic vasodilatation and portal hypertension. This stimulates the release of~     pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more~     pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut~     decontamination with Rifaximin can induce inhibition of bacterial translocation and~     associated worsening of portal hypertension. The investigators hypothesized that Rifaximin~     plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal~     varices.~   "
88642|NCT01897038|"~     This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and~     dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in~     participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive~     onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3~     will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg~     orally daily or twice daily. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
88643|NCT01897025|"~     Stroke is the most common cause of adult disability. Current treatments for functional loss~     of the upper extremity post-stroke remain limited in efficacy, particularly for those with~     moderate to severe impairment.~      Previous studies have demonstrated the efficacy of transcranial direct current stimulation~     (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is~     effective to enhance motor recovery, with activation of neural pathways similar to that of~     motor execution. This treatment is accessible to more severely impaired stroke survivors.~     Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain~     computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is~     detected by surface EEG and translated to execution of the target movement with the aid of~     an arm robot (MIT-Manus).~      In this study, we investigate the feasibility of combining robot-assisted MI-BCI training,~     with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper~     extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor~     function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI.~     Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the~     cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic~     stimulation (TMS).~      We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI)~     vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS~     each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each~     session. Primary outcome will be functional ability measured by upper extremity component of~     the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified~     Ashworth Score (measuring spasticity), grip strength and measures of brain activity~     including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging~     (MRI) measures including functional MRI and diffusion tensor imaging (DTI).~      This study will be important to develop a new and effective treatment (tDCS-BCI) for~     post-stroke motor impairment.~   "
88644|NCT01897012|"~     This phase I trial studies the side effects and best dose of alisertib and romidepsin in~     treating patients with B-cell or T-cell lymphomas that have returned after a period of~     improvement (relapsed) or have not responded to treatment (refractory). Alisertib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as romidepsin, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving alisertib and romidepsin may be a better treatment for relapsed~     or refractory B-cell or T-cell lymphomas.~   "
88645|NCT01896999|"~     This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when~     given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has~     returned after a period of improvement or has not responded to previous treatment.~     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of~     cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with~     an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster~     of differentiation (CD)30 and may kill the cells. Giving ipilimumab or nivolumab or both~     with brentuximab vedotin may kill more cancer cells.~   "
88646|NCT01896986|"~     In 2007-2009 the investigators conducted a study to determine the immunogenicity response to~     HPV vaccine in special risk patients known to be at increased risk of abnormal cervical~     cytology. The serological response to the vaccine was measured 1 month post the third and~     final dose (n=70) finding a robust response overall.~      The aim of this follow-on study is to provide data on the long-term protection offered by~     the HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and~     the impact on cervical cytology abnormalities in these special risk groups is important.~      The study results will help inform national immunisation program recommendations re- booster~     HPV vaccine doses.~   "
88647|NCT01896973|"~     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy~     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx~     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.~   "
88648|NCT01896960|"~     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.~     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and~     is one cause of this hypotension. The higher the spread of the blockade will result in a~     higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to~     spread within the intrathecal space before it will be taken up by the nerve roots. The time~     that a patient remains in one position after medication injection will affect the spread of~     the resultant anesthetic block. A patient who is left sitting for a longer period of time~     after injection of hyperbaric medication will have a lower level of block than someone who~     is placed supine immediately. In this study, the investigators wish to use up down~     sequential analysis to determine the time period a patient should remain seated after~     intrathecal injection of hyperbaric bupivacaine and fentanyl that will result in a 50% rate~     of hypotension.~   "
88658|NCT01896830|"~     The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese~     population.~      Primary objectives:~        -  To describe the safety profile of all subjects who receive at least 1 injection~        -  To describe the immunogenicity to toxin A and toxin B in all subjects from serum~          samples obtained on Days 0, 14, 30, and 60.~   "
88649|NCT01896947|"~     The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic~     resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in~     diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI~     will have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions~     utilizing arthroscopy as our gold standard test. To evaluate our hypothesis, the~     investigators will include patients suspected to have a SLAP lesion on history and physical~     examination by a fellowship trained orthopaedic surgery. Patients will be offered advanced~     imaging (both 3T MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and~     treatment after consent is obtained. A fellowship trained musculoskeletal radiologist will~     perform and interpret the magnetic resonance tests while the arthroscopy will be performed~     by orthopaedic surgeons. The diagnostic characteristics of each imaging modality, including~     sensitivity, specificity, negative predictive value, and positive predictive value, will be~     compared to each other.~   "
88650|NCT01896934|"~     The long-term goal of this line of research is to determine if decreased vascular reactivity~     and frontal hypoperfusion is associated with poor response antidepressants. Such perfusion~     deficits could contribute to antidepressant nonresponse as they would hinder improvements in~     dorsal system metabolism seen with antidepressant treatment. The objective of the current~     proposal is to determine if decreased vascular reactivity and frontal hypoperfusion in~     depressed elders predicts and persists with antidepressant nonremission. The investigators~     will pursue the primary aim testing the hypothesis that decreased reactivity and~     hypoperfusion, specifically in the dorsolateral prefrontal cortex and dorsal anterior~     cingulate cortex, predict antidepressant nonremission. The investigators will enroll 40~     depressed elders who will complete clinical, cognitive, and MRI assessments before and after~     a 12-week open-label antidepressant trial of sertraline.~   "
88651|NCT01896921|"~     This clinical study proposes to evaluate the combination of maraviroc with an integrase~     strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced~     patients to document the efficacy, safety, and tolerability of this combination in order to~     provide clinicians with a treatment regimen that minimizes the risk of metabolic~     complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART~     regimen which lessens the risk of metabolic complications could improve long-term adherence~     and reduce the risk of certain co-morbidities associated with long-term ART use. If this new~     combination is found to be as efficacious as the standard regimen with enhanced tolerability~     and improved metabolic effects, there is great potential for altering the current practice~     of HIV medicine.~   "
88652|NCT01896908|"~     Although half of the patients with HF has normal ejection fraction or slightly altered~     (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the~     pathophysiology of HF-PEF is still poorly understood.~      Sodium restriction is the most common measure of self-care oriented to HF patients for~     management of congestive episodes. The role of this orientation in the treatment of patients~     with preserved ejection fraction, however, is still unclear. The evaluation of the effects~     of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF~     can promote a better understanding of the pathophysiological progression of this complex~     syndrome.~   "
88653|NCT01896895|"~     This phase 3 study will serve to collect efficacy and safety data of two different doses of~     NT 201 in subjects suffering from Bilateral Blephorasm (BEB) who are BTX treatment-naïve.~      In this study, BTX treatment-naïve subjects are defined as those who have not received BTX~     treatment within the last 12 months for the treatment of BEB. This definition aims to avoid~     bias by comparison of treatment effects in the subject's assessments. Furthermore, this~     study will substantiate the existing efficacy and safety database for the indication BEB.~   "
88654|NCT01896882|"~     Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased~     risk for cardiovascular diseases. These complications are associated with end stage renal~     disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the~     effects of nutritional counseling restricting dietary sodium and its relation to clinical~     and diet factors, nutritional knowledge and quality of life in hemodialysis patients.~   "
88655|NCT01896869|"~     This study will enroll patients who have metastatic pancreatic cancer with stable disease on~     FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between~     patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to~     receive FOLFIRINOX.~      Funding Source - FDA OOPD~   "
88656|NCT01896856|"~     This is a phase I/randomized phase II study of the combination of SGI-110 and previously~     treated metastatic colorectal cancer patients. This study will be conducted in two~     components. First, patients will be enrolled in a phase I study of SGI-110 combined with~     irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined,~     patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and~     irinotecan versus the standard of care regorafenib or TAS-102.~   "
88657|NCT01896843|"~     Background:~      - A small brain protein called the metabotropic glutamate receptor subtype 5 (mGluR5) may~     affect several brain diseases such as autism and depression. Researchers will use 2~     radioactive chemicals ([11C]SP203 and [11C]FPEB) and a research drug (STX107) that can~     attach to the receptor, to figure out the best way to use positron emission tomography (PET)~     to see the mGluR5 receptor. They will use scans to monitor where the radioactivity goes.~      Objectives:~      - To find the best way to image the mGluR5 receptor in the brain.~      Eligibility:~      - Healthy volunteers ages 18 to 55.~      Design:~        -  All participants will be screened with a medical exam at visit 1. In later visits, they~          may have a PET scan, when two small tubes are placed under the skin and they lie down~          in a scanner. They may have an MRI scan, when they lie down in a scanner.~        -  Part 1 participants will have 2 more visits. They will have a PET brain scan using~          [11C]FPEB and will have blood drawn. Then they will have an MRI brain scan.~        -  Part 2 participants will have 1 more visit, with a whole body PET scan using [11C]FPEB~          and blood drawn.~        -  Part 3 participants will have 4 more visits, including 1 overnight stay at a hospital.~          Over all the visits, they will have 4 PET scans and 1 MRI brain scan. They will receive~          the research drug and injections of both chemicals. Blood will be drawn during the~          scans.~   "
88883|NCT01893853|"~     The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage~     intake promotes fluid balance during exercise in the heat compared with water or placebo~     intake.~   "
88659|NCT01896791|"~     Climacteric or Menopausal Transition is defined as the time period where there is a change~     to non-reproductive reproductive life, with extension of variable length. During this~     period, and after the establishment of Menopause and non-functioning ovarian, the appearance~     of various symptoms that express the depletion of ovarian follicles is common; among these~     symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In~     addition to hormonal therapy, other medications have been employed in an attempt to improve~     these symptoms; although they present better results than placebo, yet have little clinical~     impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of~     alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale~     for studying the effect of this technique in this context is its possible autonomic~     modulatory effect. What reinforces the choice of this technique is the fact that it~     demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease,~     among others. Transcranial direct current stimulation (tDCS) is a renewed method of~     non-invasive brain modulation. It is based on a transcranial application of weak direct~     currents in a non-invasive, simple and painless manner. Its use in the treatment of~     vasomotor symptoms has not been studied. The objective of this study is to evaluate the~     improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and~     compare them to a control group. This Randomized Clinical Trial will be held in female~     postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and~     Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected~     to present a new therapeutic option in the treatment of vasomotor symptoms.~   "
88660|NCT01896778|"~     This randomized pilot clinical trial studies body warming in improving blood flow and oxygen~     delivery to tumors in patients with cancer. Heating tumor cells to several degrees above~     normal body temperature may kill tumor cells.~   "
88661|NCT01896765|"~     It is unknown, if a modern prevention program, including intense nurse-coordinated education~     sessions, regular telephone contacts and a telephone hotline for 12 months, significantly~     reduces cardiovascular risk factors, clinical events and quality of life in myocardial~     infarction patients compared to usual care. Furthermore, actually no data on the additional~     effects and the feasibility of longterm telemetric care of cardiovascular risk factors~     exist.~      The primary hypothesis to be tested is that an intensive longterm prevention program~     compared to the standard of medical care, will achieve better risk factor control and~     consecutively less clinical adverse events in patients after myocardial infarctions. A~     nurse-coordinated program and telemetric prevention will be analyzed.~   "
88662|NCT01896752|"~     High-dose methotrexate therapy (HDMTX) is an important part of treatment of childhood acute~     lymphoblastic leukemia (ALL). HDMTX would be improved substantially if it were possible to~     predict the clearance of MTX for each patient and use this to tailor an individualized~     dosing of the drug. However, only about 3.7, 0.2, and 2% of the inter-individual variation~     in MTX clearance is explained by age, gender and ancestry, respectively. Genetic variation~     seems to explain about 10% of this difference, and SNPs in genes encoding transporter~     proteins (e.g. organic anion transporter 1B1 (OATP1B1) and reduced folate carrier (RFC)) are~     suggested to have a particular large impact. A serious limitation to the applicability of~     SNPs in prediction of MTX pharmacokinetics, however, is the substantial intra-individual~     variation in MTX clearance.~      The intra-individual variation in MTX clearance is related to renal function but a large~     amount of a HDMTX dose also enters the liver, where it is metabolized to 7-hydroxy MTX and~     probably also undergoes enterohepatic circulation. Thus, the aim of this study is to~     determine the role of the liver and renal function in MTX pharmacokinetics, and evaluate the~     predictive potential of pharmacogenetic (e.g. the rfc SNP) and pharmacokinetic parameters of~     MTX elimination during HDMTX.~   "
88663|NCT01896739|"~     To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular~     Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous~     administrations of DTaP and HB vaccine each administered to healthy infants, as measured by~     seroprotection/vaccine response rates 4-8 weeks post-final immunisation.~   "
88664|NCT01896726|"~     The main purpose of this study is to find out how the body absorbs and breaks down a common~     birth control pill called Microgynon when it is given with the study drug called~     baricitinib. Safety and the body's ability to tolerate baricitinib and Microgynon will also~     be studied. The study will last approximately 6 weeks for each participant.~   "
88665|NCT01896713|"~     MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy~     (TRUSBx) to improve identification of patients on active surveillance requiring treatment.~   "
88666|NCT01896700|"~     Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the~     treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis~     tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS~     to improve fatigue. It is proposed that methylphenidate may also improve imbalance and~     walking deficits in MS by improving concentration and central integration, one of the~     primary mechanisms thought to underlie imbalance and walking deficits in MS.~   "
88667|NCT01896687|"~     This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back~     pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.~   "
88668|NCT01896674|"~     The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess~     their role in the identification of coronary artery disease and abnormalities in cardiac~     structures.~   "
88669|NCT01896661|"~     Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their~     control could reduce the burden of heart disease across populations. There are several drugs~     to control hypertension, but the only consistently beneficial treatment to reduce apneas is~     continuous positive airway pressure. The demonstration that one drug could improve sleep~     apnea and hypertension would support a novel approach in the treatment of both diseases. The~     role of fluid retention in sleep apnea is known for several decades. The role of diuretics~     is well established in hypertension but was never appropriately tested in sleep apnea.~     Besides to test the efficacy of these drugs, this study will help to understand the~     mechanisms that link hypertension and sleep apnea and its treatment.~   "
88691|NCT01896375|"~     Present study is conducted on Gutkha and Pan Masala users to find out the impact of ban on~     them. It will also try to find out awareness about ban and source of information for the~     same. Availability of Gutkha and Pan Masala in post ban period will also be assessed.~   "
88670|NCT01896648|"~     Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is~     related with various complications such as sexual problems. The prevalence of erectile~     dysfunction has been widely studied in men as a complication of diabetes; the prevalence of~     sexual dysfunction in women, instead, has not been well investigated. The aim of this study~     is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using~     international validated questionnaires.~   "
88671|NCT01896635|"~     The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is~     safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by~     conducting a randomised controlled trial~   "
88672|NCT01896622|"~     Background:~      - People who have the human immunodeficiency virus (HIV) often take several medications to~     control their disease. They may also need to take medicine to prevent blood clots. Taking~     both kinds of medicine together can cause bleeding or other problems. But this might not~     happen if the medications are taken at different times. Researchers will study two~     particular HIV drugs (ritonavir and cobicistat) and how they interact with blood clot~     medications.~      Objectives:~      -To understand how HIV medicine and blood clot medicine interact, so doctors can choose what~     to prescribe for people who take both.~      Eligibility:~      - Healthy adults between 18 and 70 years old who are not on any medications.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Urine samples will be collected from participants who might become~          pregnant.~        -  Participants will visit the National Institutes of Health 7 times after the screening~          visit. Three visits will last about 12 hours. The other 4 will last about 1 hour.~        -  Participants will take a daily dose of either study medication for 22 days. They will~          keep a diary of medicine they take and any side effects.~        -  Treatment will be monitored with blood tests over about 2 months.~        -  When the study of one drug is completed, the next drug study will begin with a~          different group of participants.~   "
88673|NCT01896609|"~     A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing~     the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® ,~     Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen~     (Reiferon Retard® , Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon~     Retard® and Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian~     population. Effectiveness will be evaluated based on Sustained Virological Response (SVR) .~      PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows:~        -  To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus~          (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at~          week 60 ( 3 months after end of treatment period)~        -  Identify optimum treatment protocol for HCV genotype 4 in respect to used combination~          of medications~        -  Whether adding vitamin D, a potent immunomodulator, could improve viral response.~      STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled~     study.~      NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY:~     94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female~     subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to~     be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease~     assessed by hematological and biochemical tests.~      - DURATION OF THE STUDY: 94 weeks as follows:~      Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks~     from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database~     lock planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database~     lock. Estimated duration of subject participation: 62 weeks as follows;~        -  Screening period per subject = 2 weeks~        -  Treatment phase per subject = 48 weeks~        -  Follow-up phase per subject = 12 weeks~      N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain~     Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the~     treatment will be stopped .~   "
88674|NCT01896596|"~     In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of~     age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and~     Haemophilus influenzae type b (Hib). Infants also routinely receive a meningococcal group C~     vaccine (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and~     4 months of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also~     helps protect against hepatitis B alongside the other routine vaccinations in the UK infant~     immunisation schedule and assess their immune responses to the different vaccines. Hepatitis~     B virus infects the liver and usually affects adults, but children can be infected through~     close contact with carriers of the virus. Children with hepatitis B infection may not have~     symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many~     other countries already use Infanrix-Hexa and this study is being undertaken to help decide~     whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa~     instead of Pediacel. All other vaccines given will be the same as in the routine schedule~     but will include one MenC vaccine instead of 2 doses because the UK infant immunisation~     schedule is soon going to change so that all babies will receive only one MenC vaccine at 3~     months of age.~      There are currently several licensed MenC vaccines that can be given to babies. In order to~     check whether there are differences in protection, babies taking part will randomly receive~     one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already~     shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar~     protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects~     against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra~     dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response~     to MenC compared to the other two MenC vaccines, although all infants should be~     well-protected after their 12-month booster vaccinations, which also contain Menitorix.~   "
88675|NCT01896583|"~     This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4~     weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D~     over the 4-week treatment period.~   "
88676|NCT01896570|"~     In this study, the investigators aim to examine the prognostic role of subsequent Atrial~     Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the~     investigators compare patients who were randomly assigned to either undergo cardioversion~     after AF has been terminated to AT or further ablation until the achievement of sinus~     rhythm.~   "
88677|NCT01896557|"~     Previous reports have shown a possible drug interaction between clopidogrel and proton pump~     inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events~     among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been~     proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in~     patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t~     have any influence on clopidogrel pharmacodynamic.~   "
88678|NCT01896544|"~     Sepsis in a clinical entity that occurs in patients with serious infections. Though the~     severity of illness may vary, every year, approximately 1.6 million Americans are treated~     for sepsis. Even with timely interventions, anywhere from 16% to >80% of patients with~     sepsis will not survive. Immune dysfunction is thought to play a critical role in the~     ability for infections to evolve into sepsis and to eventually lead to death. Recently,~     vitamin D has been identified as a key regulator of the immune system. While it remains~     unclear whether optimizing vitamin D status may improve outcomes in sepsis, little is known~     about the effects of vitamin D supplementation in patients with severe infections. As such,~     our goal is to study whether high doses of cholecalciferol (vitamin D3) can improve vitamin~     D status and boost certain aspects of the immune system in patients with sepsis.~   "
88679|NCT01896531|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy of GDC-0068 in combination with oxaliplatin, 5-fluorouracil, and leucovorin~     (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic~     gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to~     receive either GDC-0068 or placebo orally daily on Days 1 to 7 of each 14-day cycle in~     combination with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is~     until disease progression or unacceptable toxicity occurs (up to approximately 2 years).~   "
88680|NCT01896518|"~     The overall aim of the current study is to determine if the use of nicotine containing~     products by caregivers who smoke and who are not interested in quitting, is effective in~     reducing children's secondhand smoke exposure.~   "
88681|NCT01896505|"~     The purpose of this research study is to find out more information such as: to determine the~     effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to~     compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology~     and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo~     biopsy).~   "
88682|NCT01896492|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting~     approximately 6-10% of women of reproductive age. Anovulation, infertility and~     hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .~      Clomiphene citrate remains the standard drug for induction or augmentation of ovulation.~     However, it is not equally effective in all situations, and therefore it may require~     additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested~     as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of~     insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for~     the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in~     PCOS .~   "
88683|NCT01896479|"~     The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a~     60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will~     test if the lower dose results in similar progression free survival (PFS) and overall~     response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events~     found in previous clinical trials of 140 mg.~   "
88684|NCT01896466|"~     The purpose of this study is twofold:~        1. Establish baseline measures of gait performance in healthy young and older adults, and~          older adults with a history of falls.~        2. Investigate the effects of gait and balance training with and without cranial nerve~          noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older~          adults.~      For the second purpose, the study will incorporate a placebo-controlled design to evaluate~     the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups~     will perform gait and postural balance training (outlined in more detail below) but will~     differ in the stimulation level of the PoNS device. The investigators will use the results~     of this study as a first step toward evaluating the benefits of CN-NINM in a falls~     prevention program.~   "
88685|NCT01896453|"~     The purpose of this study is to evaluate the efficacy of brain and peripheral electrical~     stimulation on chronic non-specific low back pain patients.~   "
88686|NCT01896440|"~     We will study the effects of ondansetron on measurements of electrical activity in the heart~     to make sure doses we are using to prevent nausea and vomiting in children receiving~     chemotherapy are safe.~   "
88687|NCT01896427|"~     In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these~     impacted third molars may provide special complication as pain, swelling, and trismus. In~     previous studies, some techniques as sutureless flap closure, modified flap designing,~     antibiotic usage, and injection of corticosteroids were presented. These methods are~     reducing post operative complications to moderate level. In this study, pain, swelling,~     trismus, general patients' satisfaction, and associated quality of life after the surgical~     removal of third mandibular impacted molars will be compared while injection of~     dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be~     injected in numbness area into medial pterygoid muscle and pterygomandibular space to~     current corticosteroid injecting non-corticosteroid methods. To achieve this aim, 75 non~     pregnant participants have single impacted mandibular third molar in healthy and without~     pericoronitis manner, after provision of written informed consent will be entered to the~     study. During the study, unwilling participants to continue the study and those with~     abnormality of wound healing process will be excluded. The included participants will be~     assigned into three 25-people groups. The surgeries were done by 3 same instructed~     experienced oral and maxillofacial residents. After the surgery pain, swelling, trismus,~     general patients' satisfaction, and associated quality of life were evaluated using~     interview of questionnaire in 48 hour, 96 hour, and one week period of time. The comparison~     was done between these three groups.~   "
88688|NCT01896414|"~     The metabolic syndrome raises the risk of heart disease and is currently at epidemic~     proportions in the U.S. It consists of 3 of the following components: central obesity, high~     triglycerides, low HDL, abnormal blood pressure and impaired fasting glucose levels.~     Previous studies have suggested that omega-3 fish oil may influence some of these components~     but the mechanisms involved are not well understood. Therefore, this proposal will~     investigate how omega-3 fish oils affect inflammation, lipids and fat breakdown by comparing~     it to placebo. Favorable outcomes from this study could translate into a new approach to~     improve heart disease risk in men and women with the metabolic syndrome.~   "
88689|NCT01896401|"~     The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access~     sites for quick hemostasis and ambulation in patients who have undergone large bore~     endovascular catheterization procedures.~      The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the~     study population.~   "
88690|NCT01896388|"~     Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the~     pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the~     NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD.~     The purpose of this study is to confirm whether ifenprodil tartrate is effective in the~     treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these~     patients, this study contributes to the development of novel therapeutic drugs for PTSD.~   "
88697|NCT01896297|"~     The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe~     renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by~     Cockcroft-Gault formula.~      The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with~     severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and~     simulation.~   "
88698|NCT01896284|"~     Patients with neovascular age-related macular degeneration who do not respond to usual~     treatment with conventional medications may respond to a new drug of the same class which is~     designed to block a larger fraction of proangiogenic factors.~   "
88699|NCT01896271|"~     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the~     stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites~     of bulky progressive disease, but also to provide antigen presentation and immune~     stimulation which is expected to act synergistically when immediately followed by the~     non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the~     response rate and complete response for metastatic clear cell renal cell cancer patients.~     Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment~   "
88700|NCT01896258|"~     As a first step towards reform of the emergency medical service system by standardizing~     triage scale to Korean Triage and Acuity Scale(KTAS), we aimed to assess the present status~     of our emergency department triage systems and illustrated the present status and problems~     of the Korean emergency department triage system.~   "
88701|NCT01896245|"~     Anesthesia induction and tracheal intubation can be performed with and without neuromuscular~     blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of~     NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are~     similar, too.~   "
88702|NCT01896232|"~     The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is~     not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH)~     levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary~     hyperparathyroidism (SHPT) who require management with hemodialysis.~   "
88703|NCT01896219|"~     Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY,~     EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of~     interventional radiology under scan in the thoraco-abdominal level.~   "
88704|NCT01896206|"~     This study will compare accuracy of a newly developed monitor for continuous non-invasive~     blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria)~     that provides beat-to-beat BP readings with two of the current and more commonly used~     intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive~     arterial line (IBP).~   "
88705|NCT01896193|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus~     ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1~     (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.~   "
88706|NCT01896180|"~     This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101~     dosed once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients~     with elevated intraocular pressure not adequately controlled with latanoprost.~   "
88707|NCT01896167|"~     In this study the investigators will investigate the following hypothesis~        -  that hypoxia induce migraine headache and migraine aura~        -  the aura phase is associated with a spreading reduction in cerebral blood flow~        -  the migraine headache is associated with dilatation of intra- and extracerebral~          arteries~        -  the migraine headache is associated with changes in brain metabolism~        -  the pre-ictal stage of a migraine attack with aura is associated with specific patterns~          in neural activity.~   "
88708|NCT01896154|"~     The aim of the study is to estimate the effect size of a 5-week consumption period of~     different dietary non-digestible polysaccharides (NPS) on antibody response to influenza~     vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether~     these NPS may enable enhancement of immune defence and to estimate the sample size for a~     confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be~     investigated.~   "
88709|NCT01895101|"~     It remains still unclear whether topical tranexamic acid has an added value besides the~     administration of intravenously tranexamic acid. We hypothesize that the addition of topical~     tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25%~     reduction of post-operative blood loss after cardiac surgery.~      The aim of this study is to determine whether the application of topical tranexamic acid~     reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac~     surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.~      Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic~     acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial~     lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group)~     receives no pericardial lavage. The main study parameter is 12 hours post-operative blood~     loss and is assessed by 12 hours post-operative chest tube production.~   "
88710|NCT01895088|"~     This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in~     subjects who are still implanted with the ACI and have successfully completed the~     ACU-P08-020/020A studies.~   "
88731|NCT01896063|"~     Insomnia is a common clinical disease.The serious patients could not sleep all night, often~     accompanied by headache, dizziness, forgetfulness and so on. All of these increase the~     mental burden of insomnia patients and seriously affected the normal work and quality of~     life of patients. Modern medical treatment to treat insomnia is using sedative and hypnotic~     drugs, mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the~     adverse reactions, including resistance, dependence and addiction. Many articles indicate~     that electroacupuncture can effectively improve insomnia, play the role of sedative and~     hypnotic effect and avoid many adverse reactions and side effects. Then there are no more~     objective indicators to affirm that which part of brain takes place the appropriate changes~     when electroacupuncture induces the sedative effect. So we designed this experiment.~   "
88884|NCT01893840|"~     A study to assess the effect of negative pulsating pressure therapy on patients with~     impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will~     increase the blood flow to the leg in these patients.~   "
88711|NCT01895075|"~     Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants~     with a high incidence and significant impact on resource utilization and long-term outcome.~     Systemic corticosteroids have been shown to be effective in the prevention of BPD through~     their potent anti-inflammatory effects but there are serious concerns on their potential~     detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids~     administered to ventilated infants are thought to be safer due to their topical effect but~     have not been shown to improve outcomes including BPD. To date, there have been few studies~     evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for~     the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot~     trial to examine the impact of inhaled budesonide on non-ventilated infants.~      The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to~     evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to~     gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a~     small cohort of preterm infants.~      This will be a single-center randomized double-blind controlled pilot trial. We will recruit~     a total of 50 infants born at less than 30 weeks gestation who are on continuous positive~     airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later.~     Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered~     three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7~     weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD,~     re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse~     outcomes.~      The prevention of BPD would have a significant positive impact on patient quality of life~     and medical resource utilization and costs. The study hypothesis is that inhaled budesonide~     on non-ventilated infants with early signs of BPD will reduce the 'days on supplemental~     oxygen' indicating a positive effect for the prevention of BPD. The result of this pilot~     study might also justify and support to proceed to a large confirmatory study to evaluate an~     effect of the intervention on BPD, in which the estimate of the impact on BPD gained in this~     pilot trial may be used to calculate a sample size.~   "
88712|NCT01895062|"~     The primary goal of this study is to determine the effectiveness and safety of delivering~     continuous negative external pressure (cNEP) to the upper airway as a means of preventing~     episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation~     associated with the use of intravenous sedation in elective colonoscopy in adult patients.~   "
88713|NCT01895049|"~     The disparity between supply and demand for organs has stimulated the development of~     strategies to increase the availability of kidney grafts. Such strategy involves the use of~     kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator,~     open, prospective, randomized, single center designed to compare the safety and efficacy of~     two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus~     thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor~     criteria expanded.~   "
88714|NCT01895036|"~     The efficacy of buprenorphine as a long-term agonist treatment has been offset by the~     emergence of intolerable withdrawal phenomena in a subset of individuals on chronic~     maintenance who attempt to discontinue the medication. Efforts are needed to better~     understand these challenges encountered with buprenorphine, as well as to develop~     interventions to facilitate medication discontinuation.~      Emerging evidence suggests that these difficulties may be related to the unique effects of~     buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors.~     Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the~     likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the~     discomfort observed during drug taper may therefore be due to the attenuation or loss of~     kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid~     activation. Naltrexone represents a promising candidate for extending kappa blockade and~     therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite~     6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser~     extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the~     mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are~     other opioids with less affinity; a careful titration of naltrexone is less likely,~     therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine,~     and the two have been combined to good effect in other settings.~      The purpose of this study is therefore to investigate the feasibility of naltrexone~     augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.~   "
88715|NCT01895023|"~     Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and~     rapid onset and offset of action.The reported incidence of emergence agitation (EA)~     following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA~     is still considered as a potentially serious complication because of the risks of~     self-injury, and because of the stress caused to both caregivers and families.~      Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic~     actions, has been used in pediatric populations.Several prospective clinical trials in~     children have shown that dexmedetomidine significantly reduces the incidence of EA prior to~     recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication~     on emergence agitation has not been fully evaluated. The purpose of the present study was to~     verify the hypothesis that intranasal premedication with dexmedetomidine is effective in~     reducing emergence agitation after sevoflurane anaesthesia.~   "
88716|NCT01895010|"~     Observation on acupoint electric stimulation combined with tropisetron in preventing and~     treating nausea and vomiting and improving the patient's appetite after TACE for primary or~     metastatic liver cancer patients.~   "
88717|NCT01894997|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES)~     have been shown to improve lower limb blood flow. However, few studies have directly~     compared the two methods and those that have, have used dated NMES techniques.~      The objective of this study is to compare the two methods in terms of blood flow, in both a~     young and an older population.~   "
88718|NCT01894984|"~     The purpose of this study is to evaluate the long-term treatment efficacy, and safety of~     risperidone long-acting injection in participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
88719|NCT01894971|"~     Single-center prospective randomized trial to evaluate the effect of thermal damage of~     Ligasure® to destroy cornual portion of fallopian tube tisse.~      Right of Left side of fallpian tube is randomized and coagulated one more time than other~     side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at~     both cornual portion of cut off specimen.~   "
88721|NCT01894945|"~     This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG~     uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites~     for infectious and inflammatory disorders. In a clinical setting, it is a challenge to~     distinguish between FDG uptake in benign and malignant lesions and this gives rise to a~     considerable quantity of false positive results and decreased positive predictive values.~     Performing FDG-PET imaging sixty minutes after injection is common practice in the staging~     and surveillance of lymphoma but this procedure may not be optimal, especially not in~     settings where benign inflammatory lesions are of clinical concern.~      In an attempt to find an alternative method for this discrimination, dual time point FDG-PET~     was introduced. This technique has shown itself to be a potentially promising method in~     FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values.~     The reason for the different FDG uptake patterns between inflammatory and malignant lesions~     is unclear. Several factors may contribute to this phenomenon on a cellular basis. It has~     been shown that cancer cells exhibit increased numbers of glucose transporter and low level~     of glucose-6-phosphatase. Varying levels between different cancer cell types may explain the~     different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake~     we believe that kinetic investigation may prove to be of value in understanding different~     types of lymphoma and identifying how to perform precise imaging for staging and~     surveillance.~   "
88722|NCT01894932|"~     Cases of physical and psychological stress problems is the need to prevent the risk of~     depression, primary care model will help to prevent depression. Many scholars have advocated~     for depression treatment not only concern symptom control and relief, prevention of~     recurrence should also be aware. The literature found cases had depression, with cognitive~     strategy bias , may cause recurrence of depression, under the influence of stress. The study~     was to assist the physical and mental disorder patient caused by stress and depression~     patient having cognitive and emotional regulation, and increased adapting Ability by ongoing~     two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and~     psycho-physiological stress regulation Group Therapy. In addition, psychological groups can~     also help regulation daily Trivia stress, study will try to know about how group therapy's~     effects on patient's immune system.Research has three purposes,to validation 2 group model's~     results in assisting psycho-physiological stressed and depression patient, to establish~     group leader training center and prepare groups' standard procedure manuals,and to~     understand the patient's psycho-physical stress reaction on the immune system and fat cell~     hormone.~   "
88723|NCT01894919|"~     The aim of this extension study is to explore the antibody persistence 24 to 36 months after~     the last dose of vaccine, in infants that received a two or three dose primary series plus a~     booster dose at 11 months of age, of the Novartis meningococcal B vaccine (rMenB + OMV NZ)~     in groups I to III of the parent V72_28 study.~      This study will also explore the antibody persistence 24 to 36 months after two catch-up~     doses of the Novartis meningococcal B vaccine (rMenB + OMV NZ) administered in children (2~     to 10 years old) in group IV of the parent V72_28 study.~   "
88724|NCT01894906|"~     The purpose of this study is to determine the quantity of iron derived from SFP that is~     transferred from the dialysate to patients during a single dialysis session. The effects of~     various conditions which may affect the transfer of iron such as blood and dialysate flow~     rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will~     also be investigated. The absorption and removal of iron from the blood will also be~     investigated.~   "
88725|NCT01894893|"~     The main objective of this clinical trial is to collect human milk samples from 0 to 4~     months after delivery in order to characterize human milk components. The secondary~     objectives of this study are:~        1. To assess whether there is a correlation between human milk composition and mothers'~          diet~        2. To assess whether there is a correlation between human milk composition and maternal~          clinical parameters~        3. To assess whether there is a correlation between human milk composition and mother and~          infant clinical parameters~   "
88726|NCT01896128|"~     Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a~     relatively safe agent with interesting neurochemical effects on the catecholamine system,~     producing an improvement in cognitive function, particularly working memory in humans. When~     combined with intensive task-related training, armodafinil may accelerate motor recovery in~     chronic stroke patients.~      The primary aim of this study is to determine whether administration of armodafinil during~     subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor~     recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by~     armodafinil and, therefore, will induce an improvement in motor function and better~     performances on measures of motor control.~   "
88727|NCT01896115|"~     The objective of the study is to compare different deep brain stimulation (DBS) settings~     using the commercially approved Boston Scientific Neuromodulation Vercise system.~   "
88728|NCT01896102|"~     This trial will assess the efficacy and safety of autologous CD34+ hematopoietic stem cells,~     transduced ex-vivo with Lenti-D lentiviral vector, for the treatment of cerebral~     adrenoleukodystrophy (CALD). A subject's blood stem cells will be collected and modified~     using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After~     modification with the Lenti-D lentiviral vector, the cells will be transplanted back into~     the subject following myeloablative conditioning.~   "
88729|NCT01896089|"~     This is a prospective, multi-center, observational study to determine if a combination of~     desensitization and enrollment in a regional kidney paired donor (KPD) exchange program~     improves the overall rate of kidney transplantation in sensitized patients.~   "
88730|NCT01896076|"~     Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in~     low abdominal or urologic surgery.~      An exact understanding of the anatomy of the sacral area including sacral hiatus and~     surrounding structures is crucial to the success of caudal block.~      The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by~     ultrasound evaluation.~   "
88760|NCT01895686|"~     The aim of this study is to analyze similarities and evaluate interchangeability of Visante~     and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and~     the two systems for evaluation of anterior segment parameters.~   "
88732|NCT01896050|"~     Early stage hormone receptor positive breast cancer is typically treated with adjuvant~     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve~     overall survival from the disease. Typical agents used for treatment include tamoxifen and~     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is~     increasingly common because it is associated with fewer long-term serious toxicities~     compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of~     patients, which can influence adherence to therapy and can lead to treatment discontinuation~     in a minority of cases. The mechanism underlying development of this toxicity remains~     unclear, and predictors of who will develop these symptoms remain undefined. Initial reports~     suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass~     index may influence development of this symptom. Therefore, this longitudinal study has been~     developed to determine change in grip strength over time in women treated with aromatase~     inhibitors and tamoxifen, as well as to identify potential associations between change in~     grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115~     women with early stage breast cancer who are initiating therapy with either an aromatase~     inhibitor or tamoxifen will be enrolled.~   "
88733|NCT01896037|"~     People with a spinal cord injury (SCI) characteristically have low levels of high-density~     lipoprotein-cholesterol (HDL-c; good cholesterol) and high levels of low-density~     lipoprotein-cholesterol (LDL-c; bad cholesterol), and are at a higher risk of developing~     cardiovascular health problems, such as heart disease, heart attack and stroke, than the~     able-bodied population. A common way for able-bodied people to improve their lipid profile~     is through exercise; however, SCI people, especially tetraplegics, are often unable to~     achieve and maintain a level of exercise needed to obtain these benefits. It is therefore~     clinically important to find an effective, safe and inexpensive method of increasing HDL-c~     levels in people with chronic tetraplegia. This study will investigate the effects of~     omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The~     investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty~     acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased~     risk of cardiovascular health issues.~   "
88734|NCT01896024|"~     The present research aims at examining the effectiveness of a specific set of therapist~     relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship~     (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients~     diagnosed with Borderline Personality Disorder.~      The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality~     Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers~     Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of~     Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne,~     Switzerland. Patients are assigned by chance to two treatment conditions 1) Control~     condition (General Psychiatric Management; Gunderson & Links, 2008) and 2) MOTR-condition.~     The investigators hypothesize better results in the MOTR-condition, as compared to the~     control condition in terms of symptom reduction pre-post.~      The conduct of the study represents a significant contribution to the understanding and~     enhancement of relationship aspects in the treatment of patients diagnosed with Borderline~     Personality Disorder which may be of potential benefit for these patients.~   "
88735|NCT01896011|"~     Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often~     occur without warning, are highly debilitating, and are slow to heal. As physicians learn~     more about them, AFFs are increasingly being identified prior to a total break. However,~     there's no evidence on the best way to treat these non-displaced AFFs. One option is~     teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct~     a double blind randomized placebo controlled trial to examine whether teriparatide use in~     AFF patients with an incomplete break will help accelerate fracture healing and prevent~     surgical intervention. Co-primary outcomes include change in WOMAC scores from baseline to~     12 months and number of participants requiring surgical intervention at 12 months.~     Investigators will recruit 60 women and men over the age of 30 who have experienced an~     incomplete AFF. Participants will be randomly assigned to either teriparatide (20 mcg/day)~     or placebo (using an identical injection pen) for up to 2 years. As AFFs are highly~     debilitating, a trial examining the use of Teriparatide in this population is urgently~     needed.~   "
88736|NCT01895998|"~     The proposed research study is a cross-sectional study enrolling young children with sickle~     cell disease between 5 and 12 years of age. They will be screened as outpatients for consent~     to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of~     bronchodilator response will be assessed at each session. To estimate presence of pulmonary~     hypertension, echocardiography will be performed at the time of PFT measures.~      Study Design:~        1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS~          beta plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established~          patients within the Duke Pediatric Sickle Cell Clinic.~        2. Perform a chart review of all enrolled subjects to obtain specific details regarding~          birth history, nutritional status (weight, height), family history, sickle cell~          genotype, parental smoking history, recent laboratory parameters, parental smoking~          history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle~          cell complications and prescribed medications.~        3. Perform spirometry and plethysmography with the administration of albuterol.~        4. Before or after completion the PFT session, the patient will have echocardiography in~          the PFT lab area~        5. Using medical record information, determine number of hospitalizations for any~          pulmonary symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing,~          hypoxia, cough, chest pain). In addition, we will track any respiratory or cardiac~          symptoms or therapies for each subject 6 years after enrollment up to age 18 years~          using the registry.~        6. As standard of care, refer any child identified as having lung disease or pulmonary~          hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment~          and ongoing care.~   "
88737|NCT01895985|"~     The objective of this study is to evaluate the effect of latanoprostene bunod dosed once~     daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy~     subjects.~   "
88738|NCT01895972|"~     The objective of this study is to demonstrate the clinical safety of latanoprostene bunod~     0.024% once daily (QD) over a 1-year treatment period.~   "
88789|NCT01895309|"~     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in~     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)~     therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects~     will be enrolled into an open label extension period. Subjects will receive SB4 for an~     additional 48 weeks.~   "
88739|NCT01895959|"~     The purpose of this study is to identify novel imaging markers for characterizing the~     biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after~     intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.~      We hypothesize that:~        1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical~          changes within knee synovial fluid after HA injection;~        2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of~          glutamate will predict patient response of pain relief after HA injection;~        3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical~          changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and~          T2 will decrease in patients who respond to the treatment, indicating potential~          beneficial effects of HA injection to cartilage preservation.~   "
88740|NCT01895946|"~     Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic~     Exposure, Safety and Tolerability~   "
88741|NCT01895933|"~     This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan~     formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after~     endoscopic sinus surgery.~   "
88742|NCT01895920|"~     This project aims at characterizing HIV-1 viral biofilms structural and functional~     properties and at deciphering its role as a new viral reservoir and as a new mode of viral~     spread. The prospective national study will be conducted on cells isolated from blood~     samples from 20 patients infected with HIV.~   "
88743|NCT01895907|"~     The purpose of this study is to examine if Special Olympic athletes's life participation~     improves through involvement with Special Olympics. This project will be undertaken in~     coordination with Special Olympics entities from Texas and around the nation to determine~     how involvement in Special Olympics improves the strengths and limitations of their~     athletes. The Short Child Occupational Profile (SCOPE) will be used to gather this~     information from the parents and coaches. The SCOPE measures the impact that personal and~     environmental factors have on a child or youth's occupational participation.~   "
88744|NCT01895894|"~     Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients~     need other immunosuppressants to reduce steroid dependency. The long-term use should be~     restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.~      Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have~     similar efficacy and fewer undesirable effects to other drugs in mainly observational~     studies. To determine the efficacy of mycophenolate mofetil in the management of~     steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized~     controlled study.~   "
88745|NCT01895881|"~     This study aims to determine if hormone replacement therapy, given during perimenopause may~     prevent the progression of saccular cerebral aneurysms.~   "
88746|NCT01895868|"~     The clinical effects of simulation-based ultrasound training has not yet been explored. To~     examine the long-term effects of training, we plan to conduct a trial, where half of all new~     residents are randomized to simulation-based training and the other half to traditional~     clinical training only. The effects are assessed after two months of practice by evaluating~     two ultrasound scans performed by the residents. These scans are subsequently evaluated by a~     blinded consultant gynecologist and rated using the Objective Structured Assessment of~     Ultrasound Skills, which has been validated in previous studies.~   "
88747|NCT01895855|"~     the purpose of the study is to determine if PXVX0200 is safe and effective in preventing~     cholera infection~   "
88748|NCT01895842|"~     The goal of this clinical research study is to find the highest tolerable dose of~     ruxolitinib that can be given to patients with low or intermediate-1 risk MDS. The safety of~     this drug will also be studied, and whether it can help to control the disease.~   "
88749|NCT01895829|"~     The goal of this clinical research study is to learn if ferumoxytol, when given at the time~     of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of~     certain kinds of cancers.~      Ferumoxytol is designed to deliver iron to treat iron-deficiency anemia (low red blood cell~     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI~     contrast. Contrasts are used by doctors in order to see MRI images more clearly.~   "
88750|NCT01895816|"~     The purpose of this study is to determine whether the effect of mixed herbals drug (citrus,~     citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male~     infertility: oligospermia~   "
88751|NCT01895803|"~     Discovery of factors affect the decision of the woman to perform or not to perform a Pap~     test.Participate in the study 100 women who smoke. Age range 18-60~   "
88752|NCT01895790|"~     This research is being done to assess the effects of pancreatic duct stenting on relief of~     obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by~     pancreatic cancer.~   "
88753|NCT01895777|"~     This open-label, randomized, parallel-group, active-controlled, multi-centre non-inferiority~     study of dabigatran etexilate versus standard of care in children from birth to less than 18~     years of age will assess the efficacy and safety of dabigatran relative to low molecular~     weight heparins or vitamin K antagonists for treatment of VTE. This study will also assess~     the appropriateness of the proposed dabigatran doses for use in paediatric patients using~     three different formulations of dabigatran (capsules, pellets and oral liquid formulation)~   "
88754|NCT01895764|"~     The purpose of this study is to determine if association of methotrexate with adalimumab~     leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.~   "
88761|NCT01895673|"~     The primary objective of this study is to evaluate the ability of PET-MRI and to detect a~     local site recurrence during the first year of follow-up after RFA or MWA of colorectal~     liver metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard~     reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in~     combination with histology (when available) or clinical follow-up.~      Secondary outcomes are the inter-observer variability, the ability to diagnose new~     intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared~     to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a~     questionnaire.~   "
88762|NCT01895660|"~     What is the CHAMP Study?~      The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health~     that is comparing the efficacy of alternative therapies for young children with unilateral~     spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility~     criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus,~     OH) will be invited to enroll, and their parents will be provided all necessary paperwork~     along with informed consent documentation. Assignment to one of the alternative therapy~     conditions will be random. Participation in the study includes assessment of each child~     prior to treatment, close monitoring of the child's progress during treatment, and~     post-treatment evaluation at the end of therapy, as well as, 6 and 12 months later. Parents~     will have an active role in the project, both observing their child during therapy sessions~     and then engaging in home-based activities that allow the child to practice and extend new~     motor skills. There will be no charge for the therapy provided.~      What are the therapies being tested? In the past decade or so, a new form of therapy for~     children with hemiparetic cerebral palsy was developed and has shown to produce positive~     changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, &~     Taub, 2003; DeLuca, Echols, Law, & Ramey, 2006; Case-Smith, DeLuca, Stevenson, & Ramey,~     2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a~     multi-component form of therapy in which the child has the unimpaired or less impaired upper~     extremity constrained (by a cast or a splint) while also receiving active therapy from a~     specially trained therapist who shapes new skills and functional activities with the child's~     more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often~     lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important~     clinical and scientific questions that need to be answered about the effects of different~     dosage levels and about different types of constraint on the child's more functional (less~     impaired) arm and hand. This study will be the first that will directly compare different~     amounts of therapy and different types of constraint to evaluate what works best for young~     children. The therapy is very play-like and engaging for children, and no negative effects~     of casting or the high dosages have been detected in previous clinical trials.~      Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral~     spastic cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy,~     not currently receiving Botox (or other similar medications), and able to understand simple~     communication and instructions. In advance, the treatment will be explained in detail to~     parents and a written protocol available to share with the child's physician and other~     current therapist for review. During the one month of treatment, children will not receive~     other forms of physical or occupational therapy.~   "
88755|NCT01895751|"~     Background: Most coronary artery bypass grafts (CABG) are diseased or blocked within 10~     years of surgery meaning CABG survivors have an ever increasing risk of recurrent angina,~     heart attack and death. Given the large number of CABG survivors in the United Kingdom (UK),~     and the complexities of their clinical management, their heart health problems and related~     treatment are an increasing challenge in the UK National Health Service (NHS) and worldwide.~      There is considerable controversy in the NHS and internationally about how to best manage~     patients with prior CABG and unstable angina / non-ST elevation acute coronary syndromes~     (NSTE-ACS). This is because there is no robust evidence to inform treatment practices or~     clinical guidelines since, historically, these patients have been excluded from randomised~     trials. This is the rationale for our study.~      Aims: Our overall aim is to undertake a clinical trial of conservative non-invasive~     management with optimal drug therapy versus routine invasive management in NSTE-ACS patients~     with prior CABG during routine clinical care in NHS hospitals across the UK. Our trial is a~     proof-of-concept study of feasibility, safety, potential efficacy and health economics.~      Hypothesis: A routine invasive approach in NSTE-ACS patients with prior CABG will not be~     superior to a conservative non-invasive approach with optimal medical therapy.~      Design: The pilot study will involve 60 patients recruited in large urban hospitals (Western~     Infirmary, Glasgow Royal Infirmary) and district general hospitals (Royal Alexandra~     Hospital, Royal Blackburn Hospital (RBH)) to reflect usual practice in the UK. One of these~     hospitals (RBH) has an on-site cardiac catheterization laboratory, whereas the other~     hospitals refer patients who have been triaged for invasive management to the regional~     cardiothoracic centre (the Golden Jubilee National Hospital). In this proof of concept~     study, the investigators aim to gather information about screening, recruitment,~     randomisation, patient characteristics (including comorbidity and quality of life) and~     initial clinical outcomes to inform the design of the definitive trial. The follow-up will~     be in line with standard clinical care i.e. 30-42 days and 1 year. The investigators will~     hold data in the longer term to enable long-term follow-up analyses. The investigators will~     record information on NSTE-ACS patients with prior CABG who are ineligible to take part or~     who do not wish to be randomised as part of all follow-up registry of 'all-comers'.~   "
88756|NCT01895738|"~     Youth injured by violence is a major public health concern in Canada. It is the fourth cause~     of death and the leading reason for a youth to visit an emergency department (ED). In~     Winnipeg, 20% of youth who visit an emergency department with an injury due to violence have~     a second visit for a subsequent violent injury within the following year. This is consistent~     with studies in other jurisdictions that demonstrate that violent injury is a chronic~     condition. Youth injured by violence are in a reflective and receptive state of mind,~     rendering the emergency department setting appropriate for intervention. The investigators~     propose a WrapAround Care model delivered by a support worker with lived experience with~     violence, supported by a social worker, an addictions and mental health counsellor, a family~     counsellor and links to multiple community partners. Support workers will be on call 24~     hours a day, 7 days a week in order to start the intervention in the ED and take advantage~     of the teachable moment. The proposed study is a pilot randomized control trial to assess~     the feasibility of a randomized control trial designed to assess efficacy. For the pilot~     trial the investigators will assess recruitment, treatment fidelity, participant adherence~     and safety. The intervention arm will receive wraparound care initiated at the time of their~     visit for injury due to violence. The control arm will receive standard of care (usually a~     list of community contacts). The investigators will use an adapted pre-consent randomization~     methodology. This intervention has been developed using a community based participatory~     research approach. Our team includes clinicians, nurses, social workers, community youth~     workers, ex-gang members, elders and researchers.~   "
88757|NCT01895725|"~     The proposed project is a prospective observational, single-center cohort study aimed to~     examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque~     volume) during a follow-up of up to four years and to correlate the observed changes with~     traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with~     or established cardiovascular disease or at least one cardiovascular risk will be tested~     with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D~     quantitative plaque volumetry. Plasma samples will be collected and tested for traditional~     and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will~     be repeated once per year to assess changes in these parameters over time depending on~     treatment modalities, which are left to the discretion of the treating physicians. The~     primary endpoint of the planned study will be the correlation between P-selectin and the~     progression of atherosclerosis as measured by plaque volume and IMT in the carotid and~     femoral arteries, respectively. Secondary endpoints will include the correlation of~     established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,~     P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1~     (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation~     of cardiovascular events with the progression of atherosclerosis and the additional~     predictive value of plaque volume and IMT compared to an established risk score (SCORE~     card).~   "
88758|NCT01895712|"~     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to~     long-term complications range from rather immediate elastic recoil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from~     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents~     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug~     Eluting Stents (DES) significantly improved on the principle of BMS by adding an~     antiproliferative drug (directly immobilized on the stent surface or released from a polymer~     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the~     incidence of restenosis and resulted in a better safety profile as compared to BMS with~     systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      An interesting group of analysis resulted to be diabetic patients. It has been concluded~     that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic~     subjects after stenting as judged from comparison with historical control subjects. Results~     implicate accelerated restenosis as both a consequence of diabetes and a cause for increased~     mortality after PCI in diabetic patient.~      Therefore this observational registry has been designed for the clinical evaluation of the~     Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary~     revascularization with Drug Eluting Stents (DES). Results will contribute to the collection~     of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in daily clinical practice.~   "
88759|NCT01895699|"~     Contrast medium is essential for diagnosis of many diseases. However, recent studies showed~     that contrast agents can induce renal injury and is associated with poor long-term clinical~     outcome, especially in diabetes. To date, no data are available on the relationship between~     contrast medium and endothelial function. Endothelial dysfunction is known to precede~     atherosclerosis and is considered a risk marker for future development of cardiovascular~     disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction~     in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction~     via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial~     dysfunction induced by contrast agents.~   "
88763|NCT01895647|"~     Rationale : Electric muscle stimulation reduced critical-illness related weakness in~     patients with severe sepsis and septic shock. But optimal protocol of the stimulation in~     unknown.~      Hypothesis: Focal muscle contraction may improved the muscle power and have systemic~     anti-inflammatory via cytokine secretion . The difference of electricity used in upper limb~     or lower limb stimulation may lead to different effect.~      Study design: Stratified randomized parallel control study, comparing Biceps, Quadriceps~     electric muscle stimulation vs. non-stimulation group.~      Participant: adult patients with severe sepsis and acute respiratory failure requiring~     mechanical ventilation.~      Intervention: daily stimulation of bilateral Biceps or Quadriceps by programmed electric~     devices 32 minutes, 5 days/week~      Outcome:~        1. Primary outcome: Ventilator-dependent days~        2. Secondary outcome: change of hand drip muscle~          power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha~   "
88764|NCT01895634|"~     The main objective of this study is to document that the thrombectomy catheter (Rev-01) is~     effective and safe when used for revascularization in subjects with acute ischemic stroke~     within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom~     treatment with IV t-PA has been ineffective.~   "
88765|NCT01895621|"~     The postoperative course of the decompression of the median nerve in the carpal tunnel~     syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms,~     or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to~     be a powerful and effective antioxidant with neuroprotective and neurotrophic properties.~     Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure.~     Its action as a dietary supplement may positively modulate and accelerate healing after~     decompression of the median nerve.~      The aim of the study is to explore any possible effects of this molecule in the~     postoperative period after decompression of the median nerve at the wrist.~      Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization,~     patients will be placed into one of two groups:~      Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg~     daily for 40 days.~      Group B: surgical decompression of the median nerve followed by treatment with placebo~      The primary endpoint of the study will be Nerve conduction velocity at 3 months after~     surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.~   "
88766|NCT01895608|"~     The first goal of this study is to examine the extent to which the inclusion of dual-task~     practice to standard balance rehabilitation results in greater benefits to dual-task~     ability. The second goal of this study is to examine the extent to which the addition of~     cognitive training following balance rehabilitation results in greater benefits to dual-task~     ability.~   "
88767|NCT01895595|"~     Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to~     reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease~     risk in obese Latino adolescents. The overall purpose of this study was to determine whether~     guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a~     lifestyle intervention. The specific objectives were: 1) To pilot test a new 12-week~     lifestyle intervention in obese Latino adolescents, in order to determine the effects of the~     mind-body technique of Interactive Guided ImagerySM, over and above those of healthy~     lifestyle education, on eating and physical activity behaviors, stress and stress~     biomarkers, and hormonal markers of diabetes risk; and 2) To explore the way that changes in~     stress produced by the intervention were associated with changes in hormonal markers of~     diabetes risk, particularly insulin resistance. The investigators hypothesized that~     participants who received guided imagery program in addition to the healthy lifestyle~     education would show greater improvements in insulin resistance, physical activity, dietary~     intake, and stress, than those receiving the healthy lifestyle education without the guided~     imagery. The investigators further hypothesized that reductions in stress due to the~     intervention would be associated with improvements in insulin resistance, a major hormonal~     marker of diabetes risk. For this study, obese, Latino adolescents (age 14-17) were~     randomized to receive either 12 weekly sessions of the lifestyle education plus guided~     imagery program, or lifestyle education plus a digital storytelling computer program (as a~     control). Outcome measures were assessed before and after the 12-week intervention,~     comparing the differences between the intervention groups behavioral (eating and physical~     activity behaviors), biological (insulin resistance and stress hormones), and psychological~     (stress) outcomes.~   "
88768|NCT01895582|"~     Background: Diagnosis and screening for latent tuberculosis in old patients is of special~     interest in regards of the morbidity-mortality of this disease in that context.~      TB-infection diagnosis based on immunological memory detection can be impaired with age. New~     blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in~     those old patients.The primary endpoint of this study is the evaluation of the IGRAS for~     active TB diagnosis in patients above 75 years old.~   "
88769|NCT01895569|"~     The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic~     agents to reach the adequate glycemic control. The aim of the study is to evaluate the~     effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic~     variability compared to metformin monotherapy, and compared to a combination of metformin~     and pioglitazone. To assess glycemic variability a continuous glucose monitoring system will~     be used.~   "
88770|NCT01895556|"~     The purpose of this study is to measure the behavioral effects of learning information about~     male circumcision and HIV risk on sexual behavior and the demand for male circumcision.~   "
88771|NCT01895543|"~     Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation~     (CIC)~   "
88772|NCT01895530|"~     The investigators would study about impact of the administration of probiotics in the~     intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by~     quantitative real time PCR. The investigators believe that patients who use probiotic~     preoperative would provide cytokine profile less inflammatory than those of the control~     group.~   "
88773|NCT01895517|"~     The aim of this study is to assess efficacy of the screening with concurrent liquid-based~     cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.~   "
88774|NCT01895504|"~     Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the~     rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult~     for different reasons, and features of the colonoscope and the use of imaging devices may~     influence the success rate. We want to compare the performance of a new colonoscope with~     novel features including gradual stiffness with that of a colonoscope supplied with a~     magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new~     instrument is non-inferior to the MEI system.~   "
88775|NCT01895491|"~     The main objective of this study is to evaluate the safety of VM206RY in subjects with~     expression of HER2 in breast cancer.~   "
88813|NCT01894776|"~     Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to~     characterize the pharmacokinetic properties of maraviroc alone and when administered with~     rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to~     the literature.~   "
88776|NCT01895478|"~     This study examined whether the Pediatric Asthma Control and Communication Instrument for~     the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the~     emergency department accurately assess a child's asthma control.~      This study involved an intervention with the doctors in the emergency department of an urban~     pediatric hospital. The intervention was done when one of the doctors involved in the study~     treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on~     the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the~     PACCI-ED results and half were not. The two groups of doctors were compared on their ability~     to correctly identify asthma control categories, whether a child's asthma was worsening or~     improving, whether the family was administering controller medications as often as they~     should, and how much burden the child's asthma was for the family.~   "
88777|NCT01895465|"~     The population of children presenting to the Emergency Department (ED) for treatment~     increases day by day, creating a further burden on the limited nursing staff and where many~     children and their parents are forced to wait many hours until their medical investigation~     ends. Part of the many hours waited are for various tests the patient has to undergo, where~     the urine test is one of the main ones.~      Urinary tract infections in children are a common cause of death due to acute and chronic~     complications alike. Our study aims to test a urine collection method to see whether it~     reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's~     percentage of contamination.~   "
88778|NCT01895452|"~     This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to~     continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects~     with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue~     treatment.~   "
88779|NCT01895439|"~     1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical~          scale according to Good Laboratory Practice using xenogenic free media instead of the~          previously used FCS.~        2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients~          who fail to respond to conventional treatment.~        3. Assessing the therapeutic benefits on the participants in the trial as per established~          methods.~   "
88780|NCT01895426|"~     The purpose of this study is to collect clinical and radiological mid-term (2 years) data on~     the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF)~     limited to 32 patients.~   "
88781|NCT01895413|"~     This is a non-randomized study aimed to determine the safety and efficacy of intra-articular~     injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee~     articular cartilage defects.~   "
88782|NCT01895400|"~     The purpose of this study is to determine whether Renexin is effective in the treatment of~     vestibular symptoms in patients with recurrent vestibulopathy.~   "
88783|NCT01895387|"~     We determined the effects of dietary intervention (replacement of refined rice with whole~     grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and~     enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired~     fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.~   "
88784|NCT01895374|"~     Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.~   "
88785|NCT01895361|"~     The purpose of this study is to determine whether the investigational drug SelG1 when given~     to sickle cell disease patients either taking or not taking hydroxyurea is effective in~     preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the~     bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may~     prevent small blood vessels from becoming blocked and therefore reduce the occurrence and~     severity of pain crises. Other effects of SelG1 will also be evaluated, as well as the~     safety of the drug and how long it stays in the blood stream.~      Funding Source - FDA Office of Orphan Products Development (OOPD)~   "
88786|NCT01895348|"~     Obstructive sleep apnea is a common disease, associated with cardiovascular disease,~     cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis~     and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional~     evaluation of upper airway and airway obstruction could be possible. The problem of the DISE~     is that there is the difference between a sedative-induced sleep and normal sleep. Moreover~     there were no standard sedation protocol of DISE. Propofol has short half-life, about 3~     minutes, so the patients could recover quickly from it. In recent years, using target~     controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could~     be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot~     study, the endoscopy for the diagnosis of sleep apnea could be done successfully with~     propofol TCI. However there were some desaturation events, although the EEG showed that the~     patient was not in deep sleep enough. Therefore we thought that not only further study of~     propofol for DISE but also the study of other drugs for DISE will be needed to overcome this~     limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect~     and almost no respiratory depression, therefore it could be a good alternative drug for~     DISE. The purpose of this study is designing the appropriate sedation protocol for DISE~     using propofol or dexmedetomidine, and enabling the safer and more accurate DISE.~   "
88787|NCT01895335|"~     Primary Objective:~      To describe efficacy, tolerability and convenience of teriflunomide treatment through the~     evaluation of Participant Reported Outcomes (PROs).~      Secondary Objectives:~      To describe disease progression using PROs. To describe clinical outcomes (ie, treated~     relapses) in teriflunomide treated participant.~      To describe the change in cognition in teriflunomide treated participants. To describe~     safety of teriflunomide in participant treated (based on adverse events reporting).~      To describe adherence and persistence to teriflunomide treatment. To describe quality of~     life, activity and leisure over the period of teriflunomide treatment.~      To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale~     (EDSS) in assessing Multiple Sclerosis (MS) disease progression.~   "
88788|NCT01895322|"~     To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in~     patients with chronic renal failure who are undergoing peritoneal dialysis, using daily~     urine volume, body weight, and edematous conditions as parameters and conducting dose~     escalation every 2 days until reaching the dose that achieves urine volume increase and then~     performing 5-day repeated administration at the fixed dose, the final dose used in the dose~     escalation period.~   "
88790|NCT01895296|"~     Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release~     of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an~     hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known~     which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this~     trial is to evaluate :~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during~          OGTT).~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response~          (during OGTT).~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters~          of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after~          an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as~          measured by the combined Dumping Syndrome score~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured~          by (a) early and (b) late phase dumping symptom score separately~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL~          SF-36)~   "
88791|NCT01895283|"~     Muscular dystrophy is a group of disorders that are characterized by progressive muscle~     weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy~     is almost always inherited disorders, and so far, no curative treatments exist.~      Previous studies have shown that endurance training significantly improves fitness and~     self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish~     to investigate whether patients with Bethlem myopathy (a specific form of muscular~     dystrophy) also benefit from endurance training.~      The study consists of two test days, a 10-week training period and five blood tests.~      Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer~     with a specific training intensity, under pulse rate monitoring.~      The training period will be flanked by two test days, where we will determine, and compare~     the patients' muscle strength and fitness level, from before to after the training program.~     The patients conditioning level will be determined from a 15 minute cycle ergometer test and~     patients will undergo three functional tests to determine their functional muscle strength.~      We will as a safety measure analyze blood tests before, during and after the training~     program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through~     adverse effects as reported by patients during weekly telephone-consultations with the~     Principal investigator.~      We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and~     functional muscle strength, as that seen in patients with other forms of muscular dystrophy,~     who undertake a similar training program.~   "
88792|NCT01895270|"~     This application seeks to address the problem of opioid withdrawal by examining the utility~     of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification.~     This project will address the need for improved detoxification strategies by assessing the~     tolerability and preliminary efficacy of adjunct isradipine during a BUP detoxification in~     opioid-dependent participants. This pilot clinical trial will determine the potential~     utility of the L-type CCB isradipine to improve treatment outcomes in up to 60~     opioid-dependent individuals undergoing a BUP detoxification procedure. Specifically, this~     study will determine the efficacy of isradipine to reduce withdrawal symptoms, craving, and~     illicit use of opioids in opioid-dependent individuals undergoing BUP detoxification and~     determine the tolerability and safety of controlled-release isradipine (10 mg/day) in~     opioid-dependent individuals undergoing BUP detoxification. Currently, the only FDA-approved~     medications for opioid withdrawal are the opioid agonists methadone and BUP, both of which~     have abuse liability. Our findings, if positive, will support a larger phase II clinical~     trial.~   "
88793|NCT01895257|"~     The investigators propose to conduct a randomised phase III trial evaluating a maintenance~     strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus~     continuing simplified chemotherapy with/without targeted therapy versus continuing~     simplified chemotherapy with/without targeted therapy alone for patient with dominant or~     exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.~   "
88794|NCT01895244|"~     Autologous stem cell therapy has been shown to be effective in patients with systemic~     sclerosis. Nevertheless treatment is associated with treatment related mortality and~     patients die during follow up despite successful transplantation.~      Intention of this trial is to improve overall survival by modifying the existing protocol~     used for the ASTIS trial.~      To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation~     to 2x1g.~      Especially in patients with cardiac manifestations we also modify the conditioning regimen~     by adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.~   "
88795|NCT01895231|"~     The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000~     compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L~   "
88796|NCT01895218|"~     The primary purpose of this study is to compare the efficacy of IV high single dose infusion~     of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical~     fatigue.~   "
88797|NCT01895205|"~     The primary purpose of this study is to get explorative information about IV high single~     dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of~     severe PP-IDA evaluated as physical fatigue~   "
88798|NCT01895192|"~     A new concept for observing the fine morphology of spermatozoa at high magnification (x6000)~     with an inverted microscope, a numeric camera using differential interference contrast has~     been developed (1). This technique called Motile Sperm Organellar Morphology Examination~     allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles~     appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3,~     4). The application of Motile Sperm Organellar Morphology Examination may represent an~     improvement in the evaluation of semen quality, with some potential clinical repercussions~     at the diagnostic/prognostic level. First of all, the investigators need data on fertile men~     in order to define  normality  of sperm morphology at high magnification. The aim of this~     study is therefore to better characterize these vacuoles (number, surface, position) in a~     population of men fertile in order to establish normality criteria.~   "
88836|NCT01894464|"~     The Early Truancy Prevention Project is designed to prevent elementary school truancy~     through teacher-led interventions that are individualized to meet student needs.~   "
88799|NCT01895179|"~     The purpose of this pilot study is to find out what eating meals in a short time period~     early in the day (time-restricted feeding) versus eating meals spread out during the day~     (grazing) does to the body's ability to control blood sugar and to the health of its blood~     vessels.~      The investigators hypothesize that time-restricted feeding will be more effective at~     improving glucose tolerance and vascular condition (inflammation and micro- and~     macro-vascular function) than grazing.~   "
88800|NCT01895166|"~     The purpose of this study is to evaluate the efficacy and safety of endobronchial~     ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs)~     without radiographic fluoroscopy.~   "
88801|NCT01895153|"~     The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in~     patients with bladder pain syndrome.~   "
88802|NCT01895140|"~     The purpose of this study is to evaluate the clinical and economic impact of implementation~     of renal denervation with the Symplicity™ Catheter System for treatment-resistant~     hypertension in Ontario, Canada.~   "
88803|NCT01895127|"~     This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and~     Immunoglobulin (IVIg) for the treatment of AMR in renal transplant recipients. All patients~     will be evaluated from the time of AMR diagnosis for 12 months.~   "
88804|NCT01895114|"~     The purpose of this study is to help determine whether cystatin C is a more sensitive~     laboratory measurement for renal function in cirrhotic patients.~   "
88805|NCT01894880|"~     In the past decades frequency of cesarean section was increasing. Bonding or early~     skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery~     bonding/early SSC is already well-established. After cesarean section this important process~     starts after termination of operation. A Cochran review analyzed randomized studies and~     shows positive effects of early SSC. Possible concerns to adopt bonding in the operating~     room are beside organizational ones (change of established processes) also a different~     ambiance in the operating room (temperature, light, noise). In a prospective randomized~     trial, early SSC after cesarean section should be analyzed.~      Hypothesis~      Mothers, who have the chance to bond immediately after birth in the operating room, have~     lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels.~     Adaptation of the newborn is within the normal range. Early bonding has a further positive~     effect on breast feeding, maternal pain processing and mental health.~   "
88806|NCT01894867|"~     Several studies have shown in patients magnesium deficiency with liver cirrhosis.~      Patients with liver cirrhosis showed considerably reduced muscle strength and muscle~     magnesium.~      We suggest addition of magnesium to patients with established cirrhosis in order to reduce~     the neuromuscular and neuropsychiatric manifestations of chronic liver disease.~   "
88807|NCT01894854|"~     The aim of this study is to further investigate the clinical and radiological importance of~     design changes in cementless hip prosthesis. The investigators have earlier evaluated the~     classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a~     further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore,~     comes with and without a collar, and the investigators are going to randomize between the~     two. The investigators hypothesize that the new design will be easier to implant and will~     present equal or less migration than the older designs which would imply a favourable~     outcome in the long term. The investigators further hypothesize that the collar play no~     major part for the long term migration and bone remodelling.~   "
88808|NCT01894841|"~     The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors~     in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an~     innovative, telephone-based intervention that combines elements of individual therapy, case~     management, and significant other/family therapy and is designed to be integrated into a VA~     system.~   "
88809|NCT01894828|"~     The aim of the study was to assess the effect of nutritional supplementation on nutritional~     status and postoperational complications in cancer patients with no clinical signs of~     malnutrition~   "
88810|NCT01894815|"~     Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with~     antidepressant drugs, which are limited for issues such as refractoriness and adverse~     effects. In this context, the investigators investigate a non-pharmacological treatment~     known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly~     effective than antidepressants would have a tremendous impact in clinical psychiatry, since~     tDCS is virtually absent of adverse effects. Its ease of use, portability and low price are~     also interesting characteristics for using in primary and secondary health care. Thus, our~     aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a~     non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing~     active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our~     primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a~     noninferiority margin of at least 50% of the escitalopram-placebo effect.~   "
88811|NCT01894802|"~     The purpose of this research study is to demonstrate the safety and efficacy of using two~     CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and~     microstimulation of brain sensory cortex.~   "
88812|NCT01894789|"~     Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary~     syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial~     tissue. Overall benefits of one drug over the other is neutral in this generally unstable~     population. In pre-clinical trials, ticagrelor showed secondary effects, involving the~     release of adenosine to heart muscle where the demand for blood was increased due to a~     stress condition. Blood flow was increased, potentially preventing potential damage.~      This study will compare ticagrelor, currently only approved for use in ACS patients, against~     clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this~     phenomenon. The effect on blood flow will be measurable by using two specific doses of~     adenosine as the pharmacologic stress and correlating with measurements of blood flow using~     positron emission tomography (PET) nuclear imaging.~      This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion~     will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects~   "
88879|NCT01893905|"~     The main objective is to assess the efficacy of a new formulation containing chondroitin~     sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary~     osteoarthritis of the knee.~   "
88814|NCT01894763|"~     Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by~     placement of a stent (a flexible, expandable tube that props open the blockage caused by the~     cancer). Stents are effective but can cause complications. Stents come in different~     diameters. The purpose of this study is to learn if stents of different diameters are more~     or less effective for treatment of dysphagia caused by esophageal cancer.~   "
88815|NCT01894750|"~     The purpose of this study is to pilot and feasibility test an innovative cognitive~     behavioral intervention to improve heart failure self-care among community dwelling older~     adults.The primary aim of this study is to test the effect of the intervention on improving~     heart failure self-care, knowledge and Health related quality of life at 1 month and 3~     months. We will test three hypotheses comparing 60 older adults with heart failure randomly~     assigned to either the intervention or a control group:~      Hypothesis 1. Participants in the intervention group will have significantly improved heart~     failure self-care than control participants.~      Hypothesis 2. Participants in the intervention group will have significantly improved~     knowledge about heart failure and heart failure self-care than control participants.~      Hypothesis 3. Participants in the intervention group will have significantly better Health~     Related Quality of Life than control participants.~      A secondary exploratory aim is to assess and describe implementation feasibility of~     providing a heart failure self-care intervention in a community group setting.~   "
88816|NCT01894737|"~     The primary aim of this study is to determine the effect of creatine supplementation on~     muscle mass loss during short-term immobilisation in healthy, young people.~   "
88817|NCT01894724|"~     This study designed to evaluate the safety and feasibility of the NeuroSave device to~     rapidly reduce brain temperature while maintaining the brain at a lower temperature than the~     body core during cardiac surgery.~   "
88818|NCT01894711|"~     AIM To determine the value of trastuzumab in the early breast cancer setting in the~     Netherlands.~      RESEARCH QUESTIONS / OBJECTIVES~        1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is~          it given?~        2. Is the introduction of trastuzumab in early breast cancer cost-effective for the~          Netherlands?~      To address the research questions (objectives), the following outcome measures will be~     determined:~      CLINICAL OUTCOME MEASURES~        1. Actual trastuzumab administration as opposed to planned trastuzumab administration~        2. Selection criteria for chemotherapy and trastuzumab in daily practice~        3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac~        4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab~           ECONOMIC OUTCOME MEASURES~        5. Volumes and costs of diagnostic tests and therapies including those for (distant)~          relapse~        6. Cost-effectiveness of trastuzumab in clinical trials versus in real world~   "
88819|NCT01894685|"~     Several studies indicate that mesalazine might have a preventive effect on recurrence of~     adenomas in patients with and without inflammatory bowel disease. As mesalazine has limited~     adverse effects, it is an attractive candidate for chemoprevention. In this study we aim to~     investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal~     adenomas.~   "
88820|NCT01894672|"~     The purpose of this phase II study is to find out if an investigational drug called LGX818~     can stop the melanoma from growing.~   "
88821|NCT01894659|"~     Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several~     hundred procedures during their hospitalization. Many of these are tissue-damaging~     procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel~     observation that exposure to a single TDP can significantly increase ATP utilization and~     oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and~     malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because~     neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of~     repeated exposures to painful procedures, an important information that is currently not~     known, as the effect of this cumulative metabolic dysfunction could result in potentially~     treatable or preventable cell injury.~      Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the~     basis of its effect on behavioral and physiological pain scores. However, we found, through~     our prospective, randomized, double blind study funded by NIH, that although oral sucrose~     significantly reduced pain scores, its administration before a single TDP (heel lance)~     significantly increased ATP utilization. This is evidenced by higher plasma concentrations~     of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no~     TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern~     because preterm neonates have limited ATP stores and are susceptible to cell injury due to~     ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose~     can alter ATP metabolism, what are the effects of exposure to multiple doses of oral~     sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose~     dosages on ATP utilization, oxidative stress and cell injury? This application will also~     explore the effect of 30% oral glucose, another sweet solution currently used to relieve~     pain, on ATP metabolism.~      In this study, we will test the general hypothesis that exposure to multiple TDPs and/or~     multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter~     biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a~     prospective randomized clinical research design to test this hypothesis during days of life~     3-7 of human premature neonates. Increased ATP utilization will be quantified by~     concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress~     will be quantified by concentrations of allantoin using gas chromatography/mass~     spectroscopy, and cell injury will be quantified through urinary concentration of intestinal~     fatty acid binding protein, an early marker of enterocyte injury. Data from this application~     will provide insight into the cellular and biochemical effects of repetitive and accumulated~     TDPs and/or multiple doses of oral sucrose. With this knowledge, we will propose and test~     innovative strategies that will not only decrease pain but also will prevent cell injury or~     cell death.~   "
88822|NCT01894646|"~     Currently, only three radiotracers, (2-[18F]FA, 6-[18F]FA and [18F]AZAN), are available for~     studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET~     imaging. A crucial problem for 2-[18F] FA, 6-[18F] FA and ([18F] AZAN is low binding~     potential (BP) in extrathalamic (ET) regions, including hippocampus, cortex and caudate~     which have lower receptor densities than the thalamus. The importance of imaging~     ET-α4β2-nAChRs (ET-nAChR) has emerged from the post-mortem demonstration of altered~     densities of ET-nAChRs (but not thalamic nAChR) in neurodegenerative diseases and~     schizophrenia. PET imaging of ET-nAChR may prove to be useful in both detecting early~     changes and following functional deterioration in neurodegenerative diseases such as~     Alzheimers disease. Furthermore, PET imaging of ET-nAChR may allow investigation and~     development of new therapies acting on the acetylcholine system.~      The imaging drawbacks of the presently available nAChR radioligands have initiated the~     development of radioligands with greater binding potential by several research groups. The~     available pre-clinical data on our new radioligand [18F](-)-JHU86428 ([18F]XTRA) suggest~     that this radioligand is superior to 2-[18F]FA for quantitative PET imaging of α4β2-nAChR~     (Gao, J. Med. Chem, 2008). In baboon PET studies [18F]XTRA exhibits 200% greater brain~     uptake, 300% higher BPs and reaches steady-state in approximately 1.5 h in cortical regions~     post-bolus administration versus 6-8 h for 2-[18F]FA. In vitro binding assays shows greater~     binding affinity of XTRA and similar nAChR-subtype selectivity in comparison with 2-FA. Both~     ligands bind selectively with the β2-subtypes that are predominant nAChR subtypes in the~     mammal brain and display little binding affinity at ganglionic α3β4-nAChR.~      The current planned human protocol will be conducted to (1) determine brain distribution~     (brain uptake) and test the reproducibility (in test-retest design) of [18F]XTRA brain PET~     scans for validation of the radioligand; (2) generate estimates of the whole body and~     internal organ radiation absorbed doses from exposure to single iv administrations of~     [18F]XTRA in healthy human subjects; and (3) determine brain distribution of [18F]XTRA in~     patients with Alzheimer's disease.~   "
88880|NCT01893892|"~     This randomized clinical trial studies levocarnitine in treating patients with~     vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by~     vismodegib.~   "
88823|NCT01894633|"~     Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic~     effect associate with increase the sensibility of Radiation through leakage of~     hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and~     increase of oxidative stress in vitro. In this phase II study we evaluated the efficacy~     and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of~     Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.~   "
88824|NCT01894620|"~     This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic~     Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a~     technique that stimulates the brain by rapidly switching a magnetic field in a coil placed~     over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain~     region that we are interested in.~   "
88825|NCT01894607|"~     The goal of this clinical research is to learn how effective an ultrasound contrast agent,~     called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both~     kidneys.~   "
88826|NCT01894594|"~     The objective of this study is to assess the effect of alkali administration on bicarbonate~     and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum~     bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and~     efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses~     of escalating oral sodium bicarbonate treatment.~   "
88827|NCT01894581|"~     The United States has the highest prevalence of obesity among all countries surveyed in 2012~     by the Organization for Economic Cooperation and Development. Maternal obesity is linked~     with anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical~     complications and congenital anomalies. Changes in reproductive hormones and diminished~     oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms~     underlying these harmful effects are poorly understood and no specific treatments exist.~      This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve~     the output of hypothalamicpituitary- ovarian axis in obese women. The investigators will~     perform paired assessments before and after supplementation in 10 obese and 10 normal weight~     women. To test the pituitary and hypothalamic output, the investigators will examine the~     luteinizing hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during~     frequent blood sampling. To test the corpus luteum function, the investigators will examine~     urinary reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg))~     over an entire menstrual cycle. The investigators ultimate goal is to collect preliminary~     data for an adequately powered randomized control trial.~   "
88828|NCT01894568|"~     The purpose of this study is to compare LY2605541 to insulin glargine in Asian insulin naïve~     participants who have been treated with oral anti hyperglycemia medications. Participants~     will receive 26 weeks of treatment.~   "
88829|NCT01894555|"~     This clinical trial is examining the effect of 4-week aspirin therapy on platelet~     transcriptome in persons at high-risk for myocardial infarction or stroke due to family~     history of early-onset coronary artery disease.~   "
88830|NCT01894542|"~     The investigators have previously shown the intact protein from cod filet improves glucose~     homeostasis and serum lipid profile in overweight adults. A large amount of trimmings from~     various fish species such as cod is thrown away or sold at very low prices for animal feed,~     and analyses of the amino acid composition reveals that this can be a good protein source~     for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble~     and non-water soluble proteins. In the present study the investigators will compare these~     fractions, by studying their effects on glucose homeostasis and inflammatory markers in~     overweight/obese adults.~   "
88831|NCT01894529|"~     Stroke is accompanied by local inflammatory response and systemic immunosuppression.~     Immunosuppression markers are associated with the occurrence of medical complications~     (infections), whereas inflammatory markers are associated with worse functional prognosis.~      This prospective study tries to validate in acute stroke patients the prognostic usefulness~     of a panel of immune biomarkers that have previously been associated with various clinical~     outcomes.~      The identification of beneficial and harmful immune responses in cerebral ischemia will~     allow the prediction of the clinical course of the patients and will be helpful in designing~     immunomodulatory therapeutic strategies for acute stroke.~   "
88832|NCT01894516|"~     -  280 patients suffering from active rheumatoid arthritis who have an inadequate response~          to methotrexate will be evaluated for improvement of disease activity (efficacy) when~          taking GLPG0634 as monotherapy (3 different doses - 50mg, 100mg and 200mg once daily)~          or matching placebo for 24 weeks.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur (safety and tolerability), and the amount of GLPG0634 present in the~          blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism~          of action-related parameters in the blood (Pharmacodynamics) will be determined. Also,~          the effects of different doses of GLPG0634 administration on subjects' disability,~          fatigue and quality of life will be evaluated.~   "
88833|NCT01894503|"~     The purpose of this study is to assess the safety and performance of the steroid-releasing~     S8 Sinus Implant when used in post sinus surgery patients who present with recurrent sinus~     obstruction.~   "
88834|NCT01894490|"~     Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with~     high morbidity and mortality. In general, the patients are already malnourished, and early~     postoperative enteral nutrition is recommended. However, there is no consensus concerning~     the best enteral access route in these cases.~   "
88835|NCT01894477|"~     This phase II trial studies how well treosulfan, fludarabine phosphate, and total body~     irradiation before donor stem cell transplant works in treating patients with~     myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan~     and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant~     helps stop the growth of cancer cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this~     from happening.~   "
88837|NCT01894451|"~     This research study is a pilot study, which tests the ability of an investigational compound~     to be used in humans for further studies. Investigational means that 89Zr-bevacizumab for~     PET/CT imaging is being studied. It also means that the FDA (U.S. Food and Drug~     Administration) has not approved 89Zr-bevacizumab for PET/CT imaging for use in patients,~     including people with your type of cancer.~      89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that~     are attached to small amounts of a radioactive substance. The amount of the compound or drug~     in a radiotracer is also very small. Radiotracers are used to make images of processes that~     are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is~     made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr).~     89Zr-bevacizumab is used for an imaging procedure called positron emission~     tomography/computed tomography (PET/CT). This radiotracer has been used in other research~     studies. Information from those other research studies suggests that 89Zr-bevacizumab-PET/CT~     imaging may be able to measure new blood vessel formation to determine where the cancer is~     in your body and if your cancer is being killed by chemotherapy.~   "
88838|NCT01894438|"~     Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the~     metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis~     and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver~     (liver fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of~     steatosis.~      At present, no medication or surgical procedure has been approved for treating NAFLD and~     lifestyle modifications remain the cornerstone therapy targeting both at weight reduction~     for overweight subjects and at prevention of overweight for the normal weight individuals.~     Given that a Mediterranean dietary pattern has a beneficial effect both on the prevention~     and the resolution of the metabolic syndrome, the main aim of the present study is to~     implement and evaluate the potential benefits of an intervention based on the Mediterranean~     lifestyle in a sample of patients with NAFLD.~   "
88839|NCT01894425|"~     The main objective of this study is to investigate the association between the presence of~     HPV infection in one or both members of infertile/sub-infertile couples and the outcome of~     pregnancies obtained by assisted reproduction.~      The success of assisted medical procreation is defined as achieving a pregnancy resulting in~     the birth of a living, viable child.~   "
88840|NCT01894412|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics of~     HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous~     injection~   "
88841|NCT01894399|"~     Study Design~        -  Open, escalating single-dose design.~        -  7 ascending dose cohorts~        -  In each cohorts, subjects will receive a single dose of HM61713.~        -  Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.~   "
88842|NCT01894386|"~     This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one~     inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI~     (ICS/LABA) and UMEC/VI (LAMA/LABA).~      Subjects will receive each of the four treatments once, separated by a wash-out period of~     7-21 days between doses in a four way crossover design. There will be 4 treatment periods in~     total. During each treatment period, subjects will attend the clinical unit on Day -1 for~     standard safety assessments in addition to familiarization with the inhaler. Each subject~     will remain resident in the unit until at least 24 hours after the dose given on Day 1.~     Following completion of all four treatment periods, a follow up visit will take place 7 to~     21 days following the final dose of study medication.~   "
88843|NCT01894373|"~     to determine the therapeutic roles of CIK cells on patients with psoriasis~   "
88844|NCT01894360|"~     This will be a randomized, parallel-group, open-label, single-dose study of belimumab in~     healthy subjects to estimate the relative bioavailability, tolerability and safety of a~     single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects~     using a prefilled syringe or autoinjector. This study will also assess the usability and~     reliability of the injection devices. A total of approximately 80 subjects (40 per group)~     will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0~     milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned~     injection device. Subjects will continue to be followed for 70 days after the administration~     of belimumab.~   "
88845|NCT01894347|"~     Multi-Drug resistant pathogens (MDR) are reported worldwide with increasing incidence,~     especially in intensive care settings.~      One of the drugs which are effective against MDRs, is colistin (polymyxin E). This agent has~     been reintroduced in response to the increase of MDR pathogens and might be used more often~     in the future. Data on safety regarding the most important side effects are not sufficiently~     available. l This study evaluates the toxicity in patients who receive aerosolized colistin.~   "
88846|NCT01894334|"~     The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing,~     about 5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic~     Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury~     (ALI) is one of the main complications that happen during the perioperative period, which by~     itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries~     lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which~     happen during the perioperative period of Acute Aortic Dissection patients.~      This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery~        1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac~          tamponade and proximal high blood pressure)~        2. ischemia - reperfusion injury of aortic dissection distal organ~        3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder~        4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters,~          indicators of respiratory mechanics (oxygenation index and lung injury index) and~          biochemical indicators.~      To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and~     observe their influences on the progress and prognosis of AAD, to explore early intervention~     in the preoperative for possible risk factors and mechanisms and to evaluate their~     influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality~     of ALI and medical expenses.~   "
93712|NCT01830517|"~     This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine~     camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute~     ischemic stroke by measuring their 24-hour ambulatory BP (ABP).~   "
88847|NCT01894321|"~     Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical~     high risk patients. However, there has been no definite agreement of the additional~     cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the~     PC in surgical high risk patients. And the investigators tried to prove the PC can be~     appropriate and ultimate treatment for acute cholecystitis patients with critical illness~     through this study.~   "
88848|NCT01894308|"~     This study is a continuation of previous studies done in healthy volunteers to prove the~     efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s~     series of doses from low to high in men with low-to-no natural testosterone production to~     measure their response to the varying doses. The results of this study will inform further~     studies which will be longer in length, as to the starting doses. The study will be~     conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.~   "
88849|NCT01894295|"~     The aim of this double blind clinical trial study is to investigate whether alphacalcidol~     treatment in obese subjects can affect the resting metabolic rate. Moreover, the~     investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated~     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α~     (PGC1α) protein which may lead to change in metabic rate following treatment with either~     alphacalcidol or placebo.~   "
88850|NCT01894282|"~     This pilot study will evaluate the feasibility of having a non-behavioral health provider~     deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain~     (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the~     combined intervention of CBT-p and MT and those undergoing MT alone.~   "
88851|NCT01894269|"~     Although it is commonly accepted that antiviral therapy should be commenced before or during~     hepatocellular carcinoma (HCC) treatment if the patients have high viral loads and elevated~     ALT or total bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and~     liver function (such as ALT, AST, TBIL) remains low level. Whether antiviral therapy make~     sense or not in these patients with no signs of hepatitis or high viral replication remains~     unclear, especially for the relatively advanced stage HCC patients receiving TACE. Thus, the~     investigators carried out this prospective control study to compare the survivals for~     patients after TACE between with or without antiviral therapy.~   "
88852|NCT01894256|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     PK of olaparib in patients with mild or moderate renal impairment compared to patients with~     normal renal function; Part B will allow eligible study patients continued access to~     olaparib after the PK phase and will provide additional safety data.~   "
88853|NCT01894243|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     PK of olaparib in patients with mild or moderate hepatic impairment compared to patients~     with normal hepatic function; Part B will allow patients with mild or moderate hepatic~     impairment or normal hepatic function continued access to olaparib after the PK phase and~     will provide additional safety data.~   "
88854|NCT01894230|"~     The purpose of this study is to examine if using genetics can improve statin adherence in~     patients who should be taking statins but are not because of prior side effects. This study~     will assist physicians/providers in making a personalized health care plan for prevention of~     cardiovascular disease.~   "
88855|NCT01894217|"~     The purpose of this pilot study is to examine if using genetics can improve statin adherence~     in patients who should be taking statins but are not because of prior side effects with~     statins. This study will assist physicians in making a personalized health care plan for~     prevention of cardiovascular disease.~   "
88856|NCT01894204|"~     Forward-looking troop established(constituted) by the patients having been included in the~     study  PADIS EP , PHRC on 2006 and 2009, randomized checked(controlled), double-blind,~     comparing an anticoagulating treatment(processing) extended by coumadine versus placebo~     during 18 months at patients having had a first episode of EP idiopathique treated(handled)~     initially 6 months by anti-vitamin K.~   "
88857|NCT01894191|"~     Interval (missed) cancers and lower than expected mortality reduction of proximal colon~     cancers in the United States and elsewhere after screening colonoscopy drew attention to~     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be~     contributing factors. An independent predictor of the risk of interval cancers is adenoma~     detection rate. In pilot observations, the investigators showed that water exchange enhanced~     adenoma detection in the right colon (cecum to hepatic flexure). This prospective,~     randomized controlled trial will compare water exchange with water immersion and traditional~     air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis~     that compared with air insufflation and water immersion, water exchange produces a~     significantly higher adenoma detection rate in the right colon.~   "
88858|NCT01894178|"~     A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral~     fiberoptic intubation and concluded that there was a significant benefit in terms of~     difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has~     a flexible, curved, and tapered tip design different from traditional endotracheal tubes.~     The design allows the tube to lie closely against the fiberoptic scope that is often used to~     facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope.~     This may allow the ETT to clear anatomic obstructions more easily. The patients they~     examined had an average body mass index (BMI) categorized as normal weight. To our~     knowledge, there have not been any studies that have investigated the use of the Parker~     Flex-Tube for fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis~     is that the Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope~     during elective fiberoptic intubation of obese patients in comparison to a traditional ETT.~   "
88859|NCT01894165|"~     Phase 1 single dose study of ALXN1101 in healthy volunteers.~   "
88860|NCT01894152|"~     Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting~     Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug~     Administration (CFDA) on August 10th, 2011.~      This prospective, observational, open-label, multi-center, single-arm, post-approval study~     is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in~     a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in~     real-world settings in China.~      This study has no primary outcome measure. All observations are of equal weight.~   "
88861|NCT01894139|"~     The Nutrition Research Unit at Copenhagen University Hospital Herlev will during the fall~     2013 initiate a randomized and controlled intervention study engaging 390 obese pregnant~     women. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy~     influences the programming of the offspring. The children will after birth be included in a~     prospective cohort according to maternal randomization and examined six times from delivery~     until the age of nine years.~   "
88862|NCT01894126|"~     With the increased prevalence of cellular phones, mobile technology provides an important~     tool to reach underserved populations in low to middle income countries. mHealth~     interventions offer promise to improve maternal child health throughout the reproductive~     health continuum if they contribute to increasing skilled birth attendance, family planning~     and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of~     using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on~     uptake of reproductive and neonatal health services and maternal and infant outcomes~   "
88863|NCT01894113|"~     The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to~     forceps biopsies to diagnose an interstitial lung disease~   "
88864|NCT01894100|"~     Limb length inequality is when a person has one leg that is longer than the other. This~     research will look at correcting limb length inequality in adults with knee or hip symptoms.~     This study will examine whether ways of measuring leg length inequality in the clinic are~     valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is~     related to leg length inequality, and determine whether shoe lifts are a helpful treatment~     for leg length inequality and knee/hip symptoms.~   "
88865|NCT01894087|"~     Unintentional poisoning is a developing public health problem in the U.S. Unintentional~     poisoning (or overdose) deaths increased 157% among adults between 1999 and 2008. There~     were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related~     overdoses, particularly prescription opioid overdoses, have accounted for much of this~     increase. There have been parallel increases in sales of opioids (with a 6 fold increase~     between 1997 and 2007), as well as both medical and non-medical use of prescription opioids.~     Prescription opioids are now among the most common of drugs used non-medically in the U.S.~      The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription~     opioid overdose prevention intervention. We will examine therapeutic alliance, perceived~     satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on~     precursors of overdose risk behavioral change immediately post-intervention. We will compare~     intervention and control participants on knowledge, self-efficacy, readiness to change, and~     behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects~     on overdose risk behaviors six months post-intervention. We will compare intervention and~     control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in~     combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and~     sedatives); and, 3) route of administration.~   "
88866|NCT01894074|"~     This is a study to determine whether a low calorie diet using meal replacement shakes~     compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if~     needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either~     spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions~     in waist and hip circumferences and improvements in hormones that are involved in allowing~     pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose~     (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and~     physical well-being.~      Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight~     in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory~     infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).~   "
88867|NCT01894061|"~     NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the~     FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma~     multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields~     within the human body using surface electrodes (transducer arrays). Intermediate frequency~     electric fields (TTFields) stunt the growth of tumor cells.~      The purpose of this study is to determine the efficacy of the combination of Bevacizumab and~     NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients~     with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.~   "
88868|NCT01894048|"~     The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to~     keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be~     required in order to gain control of asthma, and this is usually guided both by symptoms and~     simple measurements of lung function such as peak flow.~      The airways (breathing tubes) in the lungs get smaller the further into the lungs they go.~     Most simple measurements of lung function only reflect the larger 'central' airways and~     don't provide information on the smaller 'peripheral' airways.Newer measurements have been~     developed that can now give us accurate information on how the smaller airways are~     working.Indeed the small airways seem to play a significant role in asthma in terms of~     inflammation and airway narrowing.~      Recently, new types of steroid inhalers have been developed that have a much smaller~     particle size than other standard inhaled steroids.These have been shown to go deeper into~     the lungs, thus getting into the smaller airways. There have been a few studies suggesting~     that this might improve asthma control. However, we do not know if when small airway~     function is shown to be abnormal, whether this improves with extra-fine particle inhaled~     steroids, nor whether by improving small airway function specifically this translates into~     improved asthma control.~      In this study we wish to study asthmatic patients who are not completely controlled on~     standard particle size inhaled steroids, in addition to having evidence of abnormal small~     airway function. By doing this we want to find out whether changing to the same dose of an~     extra-fine particle inhaled steroid instead will improve asthma control by getting deeper~     into the lungs and improving small airway function.~   "
88881|NCT01893879|"~     This randomized clinical trial studies an investigational drug in preventing lymphedema in~     patients at high risk after undergoing axillary lymph node dissection. The study drug may~     prevent lymphedema in patients undergoing axillary lymph node dissection.~   "
88869|NCT01894035|"~     This pilot, non-interventional, company-sponsored, multi-center study documents~     observational data on patients under routine treatment of Pulmonary Arterial Hypertension~     (PAH) with inhaled iloprost (using I-Neb device for the inhalation).~      The planned study recruitment time is 18 months. The maximum follow up period in this study~     will be 12 months.~      The data will be collected from patients who have initiated the treatment mentioned above~     (inhaled iloprost using I-Neb device) since February 1st, 2013.~      Frequency of visits and procedures will be performed under routine conditions. The primary~     objective of this study is to assess the compliance of patients with WHO/NYHA (World Health~     Organization/New York Heart Association) functional Class III Pulmonary Arterial~     Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight~     tool.~   "
88870|NCT01894022|"~     This is an open label, long term extension to Study AMB115811. All subjects may remain in~     the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may~     continue in the extension study until one of the following:~        -  The product is approved locally for use in inoperable CTEPH patients;~        -  Development for use in the CTEPH population is discontinued or product is not approved~          by the local regulatory authorities~        -  The investigator decides to discontinue the subject or subject decides to discontinue~          from the study.~      The primary purpose of this study is to provide clinically relevant information on the long~     term safety of ambrisentan in subjects with inoperable CTEPH.~   "
88871|NCT01894009|"~     Background: Asymmetrical foot posture influences the pelvic girdle stability and might give~     pain in the pelvic region. The objective was to investigate if foot manipulation to correct~     foot asymmetry can relieve pregnancy related pelvic girdle pain (PPGP) and shorten sick~     leave periods.~      Design: Randomized single blinded (patients and evaluators) clinical trial comparing foot~     with sham manipulation at 6 weekly treatment sessions.~      Setting: Five physiotherapy out-patient clinics (10 physiotherapists) in Skaraborg Primary~     Care, Sweden.~   "
88872|NCT01893996|"~     Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of~     systemic inflammation that can persist even in patients with well-controlled joint disease.~     We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard~     non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce~     cardiovascular risk) in these patients. The design of the trial is as follows: 18 month~     prospective, randomized, double-blind crossover trial comparing the addition of adalimumab~     to the addition of placebo. The primary endpoint is a change in endothelial cell function,~     as detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months~     of placebo.~   "
88873|NCT01893983|"~     The purpose of this study is to investigate health problems among rural Veterans. The~     research project also aims to test a new telephone-based approach for helping Veterans who~     need treatment connect with the appropriate care. This study will help us to better~     understand the kinds of problems Veterans experience. The study will also help us to find~     better ways to help Veterans get the help they may need.~   "
88874|NCT01893970|"~     Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with~     disabling consequences. More than one million civilians with mTBI are treated in US~     hospitals and emergency departments each year (Faul, et al., 2010). While the exact number~     is debated, approximately 10-15% of individuals with mTBI will experience prolonged and~     disabling post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009),~     and 34% will experience a psychiatric illness in the first year after injury (Fann, et al.,~     2004). In addition, at least 188,270 military service members sustained a TBI from 2000 to~     mid August 2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain~     Injury Center, 2010). Many individuals require treatment for resulting mTBI symptoms.~      The proposed study builds on preliminary research conducted by the investigators to develop~     and test the effectiveness of a social work delivered education and reassurance intervention~     for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess~     acceptability and obtain preliminary effectiveness data for an enhanced social work~     assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency~     Department (ED). SWIFT includes early education, reassurance, coping strategies, resources~     and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs~     assessment and case management referral to necessary services. The intervention targets~     cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive~     symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community~     functioning and successful linkage to community resources.~      It is hypothesized that SWIFT will be acceptable to patients and that participants in the~     SWIFT group will report superior outcomes on measures of post-concussive symptoms,~     depression and anxiety, alcohol use and community functioning and will report increased~     successful linkages to needed resources when compared to the SWIFT-Acute group.~      The specific aims of the study are:~        1. Implement an innovative social work intervention for adults with mTBI (SWIFT).~        2. Assess acceptability of SWIFT using qualitative interviews with participants.~        3. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or~          prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress~          disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning~          and successful linkage to community resources. 80 participants will be randomized to~          receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed~          using standard measures of post-concussive symptoms, the primary outcome, depression,~          anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used~          to assess linkage to community resources.~   "
88875|NCT01893957|"~     The aim of this study is to investigate the influence of electrical stimulation at the speed~     of blood circulation and tactile sensitivity of the arms of women who underwent axillary~     dissection for breast cancer.~   "
88876|NCT01893944|"~     To evaluate the influence of virtual reality and vibrational therapy in reducing pain~     intensity secondary to breast cancer before and after application of treatment protocols,~     through biomedical instrumentation.~   "
88877|NCT01893931|"~     The purpose of this study is to determine whether a phone call from a nurse within 1-3 days~     after discharge from the Emergency Department (ED) decreases return visits to the ED/~     hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary~     outcomes, time to follow up appointment with physician and economic impact of this~     intervention will be assessed.~      Patients 65 years of age and older will be randomized following discharge from the ED into~     one of two groups. Group 1(Intervention) will receive a phone call collecting information~     about understanding of ED discharge instructions and guiding patient through the discharge~     instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction~     survey.~      We hypothesize return visits to the ED and readmission to the hospital will decrease as a~     result of the nurse phone call intervention.~   "
88878|NCT01893918|"~     Cigarette smoking, the major risk factor for Chronic Obstructive Pulmonary Disease (COPD),~     causes systemic effects, such as systemic cellular and humoral inflammation, that could~     substantially contribute to the development of chronic diseases, other than COPD, mainly~     cardiovascular diseases and metabolic disorders. Such chronic comorbidities affect health~     outcomes in COPD, particularly in terms of disease severity and prognosis. The aim of the~     project is to investigate the prevalence of chronic comorbidities associated with COPD and~     their impact on prognosis in elderly patients.~   "
88885|NCT01893827|"~     The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of~     XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model.~     234 adults >18yo with alcohol dependence will be recruited from the community into treatment~     in public sector primary care settings. The primary outcome which powers this study is a~     dichotomous good clinical outcome defined by abstinence or moderate drinking, and as~     measured by the Timeline Follow-back and analyzed using an intention-to-treat approach among~     all randomized participants. Secondary outcomes include the incremental cost effectiveness~     of the two arms, differences between arms by continuous measures of alcohol intake~     (drinks/day, % days abstinent, time to first heavy drinking day, bio-markers), and the~     exploratory analysis of factors possibly associated with effectiveness, including gender,~     prior treatment abstinence, and mu opioid receptor (OPRM1) genotypes.~      Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release~     naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical~     outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1drink/day,women;~     and <2 heavy drinking occasions/month), during the final 20 of 24 weeks of primary~     care-based Medical Management for alcohol dependence. Hypothesis: The rate of this good~     clinical outcome will be approximately twice as great among participants receiving XR-NTX~     compared with those receiving O-NTX.~      Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX~     vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX~     treatment will be more cost effective than O-NTX.~      Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level~     characteristics associated with effectiveness in both arms.~   "
88886|NCT01893814|"~     To demonstrate benefit and tolerability of a probiotic product in infants with abdominal~     discomfort.~   "
88887|NCT01893801|"~     The primary objective of this study is to determine the efficacy of nab-paclitaxel plus~     cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma~     (PDA).~   "
88888|NCT01893788|"~     The primary objective of this study is to determine which treatment will be more effective~     to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy~     comparing aliskiren and eplerenone.~   "
88889|NCT01893775|"~     Background:~      - Celiac disease is a condition where the immune system attacks the cells of the small~     intestine. The intestine becomes inflamed and cannot digest food properly. The disease most~     often causes a reaction to foods that contain gluten. Most people can treat celiac disease~     with a gluten-free diet. However, some people have digestion problems even on a gluten-free~     diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may~     block the immune reaction that causes the disease. They will test this antibody in people~     who have celiac disease that has not responded to a gluten-free diet.~      Objectives:~      - To see if antibody therapy is a safe and effective treatment for celiac disease that has~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12~     months but still have symptoms of celiac disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. These samples will help determine if the specific antibody treatment~          is likely to work.~        -  Before the start of the study, participants will have a biopsy of the small intestine.~        -  Participants will receive three doses of the study antibody as injections. These doses~          will be given 3 weeks apart.~        -  Treatment will be monitored with blood tests and heart function tests. Participants~          will also have a second small intestine biopsy within a week after the last dose of the~          antibody.~   "
88890|NCT01893762|"~     Exercise induces innate immune response activation in athletes. The response starts during~     exercise and lasts for approximately 24 hours. This innate immune response shows~     similarities to the innate immune activation observed in, for example, bacterial infection~     and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine~     production is altered towards an inflammatory pattern. However, to gain insight in immune~     response, a detailed cell receptor expression is required. To investigate the physiological~     innate immune response to exercise, we developed a model in rowers.~      Aim: To determine the type and degree of cellular inflammatory response in peripheral blood~     of elite rowing athletes after both anaerobe and aerobe exercise.~      Study design:~      Investigator driven, monocenter observational pilot study.~      Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All~     competitive rowing athletes.~   "
88891|NCT01893749|"~     The purpose of this randomized multiple-site clinical study is to determine whether a~     revised CATCH-IT (Internet-based depression prevention program) is more effective than a~     general health education Internet intervention (Health Education)on teens ages 13-18~     (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of~     depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as~     compared to teens in Health Education group.~   "
88892|NCT01893736|"~     The investigators will conduct an early postpartum professional breastfeeding intervention~     to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding~     outcomes.~   "
88893|NCT01893723|"~     The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in~     order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the~     relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during~     general anesthesia. The primary endpoint of this randomized multicenter study is to measure~     whether there is a benefit to use the ANI in order to adapt remifentanil administration~     during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of~     patients presenting with at least one episode of hemodynamic reactivity, hypotension or~     bradycardia in the ANI guided group vs control group ?~   "
88894|NCT01893710|"~     Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients~     undergoes substantial morphological transformation, including progressive fibrosis,~     vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately~     results in PD failure. In children, peritoneal biopsies demonstrating PD associated~     alterations have not yet been obtained. They, however, should be particularly informative,~     since secondary tissue and vascular pathology related to ageing or diabetes is absent.~      An international, prospective peritoneal membrane biopsy study in children on PD will~     therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on~     occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at~     time of renal transplantation. Quantitative histomorphometry and tissue protein expression~     analyses will be correlated with time integrated PD treatment modalities and functional~     characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter.~     Blood will be obtained during clinical routine sampling. Biopsies will be obtained during~     clinically indicated operations, without substantially increasing operation time and~     associated surgical risks. The detailed histomorphometry of the PD membrane will give~     additional information, potentially impacting on the individual PD regime.~   "
88895|NCT01893697|"~     FRI could give the opportunity to investigate the possible effect of a lateral posture on~     airway diameter and airflow distributions. This physiological study in healthy subjects may~     help to identify the role of positioning as an aid in airway clearance techniques for~     patients with respiratory diseases.~   "
88896|NCT01893684|"~     The prevalence of obesity continues to increase at an alarming rate for all sectors of the~     population in the US. Obesity in the older adult cohort is of great concern as it is~     associated with reductions in mobility, declines in physical performance and increased risk~     for physical disability. With regard to body composition, a) fat mass has been determined to~     be a stronger predictor of mobility limitations than low muscle mass in older individuals~     and alternatively, b) leg lean mass has also been cited as a primary determinant of lower~     extremity physical function.~      Obesity is related to increased levels of fatigue and lack of motivation and mental energy.~     Fatigue can be categorized as both a subjective perception and a performance decrement.~     Fatigue can be defined as a perceived lack of physical or mental energy while fatigability~     is another construct categorized by the degree of fatigue associated with activity in any~     dimension (i.e. physical, mental, emotional, and/or social).~      The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of~     fatigue and systemic inflammation in older adults has not been well documented. The utility~     of a higher protein weight loss diet combined with resistance exercise training to augment~     fat mass loss, attenuate lean mass loss and improve muscle quality and physical function~     could potentially be of high value to overweight older women. The potential further benefits~     of this regimen to enhance mental energy and other aspects of psycho-social well-being are~     unknown.~      The aims of the present study include assessing the effects of the proposed diet and~     exercise intervention on 1) body composition, 2) strength and muscle quality, and 3) energy~     and fatigue symptoms.~   "
88897|NCT01893671|"~     The primary goal of the study is to determine if Optical Coherence Tomography (OCT)~     measurement of corneal power and astigmatism is more accurate than conventional Placido-ring~     corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The~     postoperative epithelial thickness variation will be used to calculate refractive effects~     and calibrate the smoothing parameter in the mathematical model relating corneal mean~     curvature and epithelial thickness. A third goal is to assess the repeatability of OCT~     measurements. A fourth goal is to develop a method of estimating the focusing power,~     astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and~     posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.~   "
88898|NCT01893658|"~     The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute~     Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of~     prednisone for treatment of drug-induced AIN. Currently there is no good treatment for~     drug-induced AIN. Prednisone is the standard treatment but is associated with many~     side-effects when used long-term and at high doses.~   "
88899|NCT01893645|"~     The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant~     women. The assessment of Hb involves several steps, including a needle stick, blood~     collection, blood sample analysis in the laboratory, and waiting for the results.~      Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick~     bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip~     probe, provides hemoglobin values in less than 60 seconds.~      In this prospective observational study the investigators will assess the clinical accuracy~     of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in~     obstetric patients. We will be calculating the mean difference between Pronto-7 and~     laboratory Hb values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean~     delivery at BC Women's Hospital.~   "
88900|NCT01893632|"~     Benzodiazepine dependence is a growing public health problem for which very few~     evidenced-based treatment approaches are available. Approximately 683,000 individuals met~     past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence~     greater than heroin or methamphetamine dependence. The most commonly prescribed~     sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic~     tolerance in the GABA neurotransmitter system and individuals with physiological dependence~     find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms,~     which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based~     treatment approaches have been primarily directed at therapeutic users of benzodiazepines~     who do not meet criteria for a substance use disorder, with a general consensus that the~     gradual taper of benzodiazepines over a period of several months is the optimal approach.~     However, patients with benzodiazepine dependence are typically referred for inpatient~     detoxification treatment, which rapidly tapers patients off benzodiazepines. Protracted~     withdrawal symptoms frequently persist after discharge, predisposing patients to relapse.~     More effective pharmacotherapeutic strategies are needed for the treatment of benzodiazepine~     dependence in the outpatient setting.~   "
88901|NCT01893619|"~     Observational study regarding the use of supplements in chronic fatigue syndrome patients~   "
88902|NCT01893606|"~     This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and~     safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four~     centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III~     diagnostic criteria, screening/import period pain intensity scores of the NRS week mean~     value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7~     type over 2 days/week. Test cycle includes screening/import period (2 weeks), open treatment~     period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks),~     the main outcome measures are pain intensity (NRS score 11 point scale) and stool type (~     Bristol type). And secondary endpoints included overall symptoms sensory scores, defecation~     frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale).~     After the end of the treatment period, the participants whose pain intensity and stool type~     are effective subjects into a randomized withdrawal period, analysis and comparison of the~     difference between treatment group and placebo group withdrawal rate and curative effect~     index score reduces.~   "
88903|NCT01893593|"~     This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline~     implementation in 32 clinical practices~   "
88904|NCT01893580|"~     Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has~     led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer~     diseases are after all still complex and potentially lethal.~      Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise~     to improve recovery after surgery in patients operated for lunge cancer with focus on~     physical capacity and quality of life.~      Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for~     operation. Participation in this study is not possible if the participants by a doctor are~     advised not to do strenuous exercise.~      What does the study involve? The intervention consists of a combination of (1) exercise~     before surgery and (2) exercise after surgery for lung cancer.~        1. Exercise before surgery is a home-based exercise program is individually designed and~          must be performed for at least 30 minutes every day until surgery. The home-based~          exercise program varies in length due to number of days until surgery, and the~          intention is not exceed 14 days.~        2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks~          rehabilitation program and three individual counseling sessions. Special needs in terms~          of smoking cessation, nutritional counseling or patient education, this is also~          offered. The exercise consists of individually prepared supervised strength - and~          fitness exercise in a team, two sessions of 60 minutes/week.~      What interventions will be compared? A home-based post-operative exercise program, combined~     with exercise initiated two weeks after surgery, will be compared with usual care (exercise~     initiated six weeks after surgery).~      Will all participants receive the same treatment?~      By draw it is decided which of the 4 groups the participants will attend to in the study:~        -  Group 1: Home-based exercise before surgery and rehabilitation initiated as early as~          two weeks after surgery~        -  Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks~          after surgery~        -  Group 3: Rehabilitation initiated as early as two weeks after surgery~        -  Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control~          group) What are the possible benefits and risks of participating? There are no risks or~          side- effects of participating other than muscle soreness and exercise is beneficial~          when it comes to recover from an operation from lung cancer.~   "
88905|NCT01893567|"~     The aim of this study is to investigate the utility of a technological based rating scale~     for assessing improvement in plaque psoriasis with Clobex spray treatment.~   "
88906|NCT01893554|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children around the world. This study will evaluate the safety and immune response to a~     RSV vaccine in two groups of participants: healthy children who have already had an RSV~     infection (RSV seropositive) and healthy infants and children who have not already had an~     RSV infection (RSV seronegative).~   "
88907|NCT01893541|"~     This prospective randomized controlled trial will compare endoscopic band ligation (EBL)~     with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic~     patients with high-risk varices.~   "
88908|NCT01893528|"~     This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study~     to assess the safety and tolerability of ascending single doses of REGN2009 administered to~     healthy volunteers.~   "
88909|NCT01893515|"~     The objectives of this study is~        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood~          lipids and lipoprotein parameters from baseline after 12 weeks of treatment.~        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety~          parameters~   "
88910|NCT01893502|"~     Smoking cessation improves mortality, even in patients with existing smoking-related~     morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an~     important method to provide support to smokers and to improve quit rates, especially if~     three or more calls were used in addition to face-to-face counselling. While it is~     reasonable to assume that more counselling leads to better smoking cessation outcomes,~     little evidence exists over the amount of telephone follow-up counselling that is required~     for optimal and sustained abstinence. We aim to investigate if six-months of weekly~     telephone follow-up is superior to one-month of weekly telephone follow-up.~   "
88911|NCT01893489|"~     Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not~     yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal~     mannose residues of MSA binding with the mannose receptors of macrophages in~     atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for~     non-invasive molecular imaging of carotid atherosclerotic lesion in PET.~   "
88912|NCT01893476|"~     Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem,~     which is strongly related to smoking. Despite publication of guidelines on the prevention~     and treatment of COPD, not all COPD patients receive the best available healthcare.~     Investigators developed a tailored implementation strategy for improving primary care~     physicians' adherence to COPD management guidelines. The primary aim of the presented trial~     is to evaluate the effects of this strategy on physician's performance. The secondary aim is~     to examine the validity of the tailoring of implementation interventions.~      Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1~     year will increase among participants assigned to the intervention group in comparison to~     those assigned to the control group?~      Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540~     patients with diagnosed COPD will be included from 18 general practices in Poland. A~     tailored implementation program will be offered to general practitioners. Participating~     physicians in the intervention practices (n=18) will receive training to provide brief~     anti-smoking counselling. An additional form containing COPD severity scale will be inserted~     into patient's medical records. The checklist with key information about the disease and its~     management while consulting a patient with COPD will be provided to practitioners.~     Investigators will provide practices with training inhaler devices for general practitioners~     (GPs) to teach patients in correct use of each device and to note this education/training in~     patient's medical records. The control practices will provide usual care.~      Discussion: The results of this trial will be directly applicable to primary care in Poland~     and add to the growing body of evidence on interventions to improve chronic illness care.~   "
88913|NCT01893463|"~     Early and effective control of severe bleeding is critical to survival of trauma patients.~     The iTClamp™50 is a Health Canada approved medical device for temporary wound/skin closure~     that quickly controls bleeding by sealing the skin. Similar to a clip, the device seals the~     skin edges within a pressure bar, enabling the creation of a hematoma where blood collects~     under pressure to form a stable clot until definitive repair. The iTClamp50 is indicated for~     use as a skin closure device for short-term soft tissue approximation, including use in~     trauma wounds, lacerations, junctional bleeds or surgical incisions. The purpose of this~     prospective clinical study is to evaluate the effectiveness and safety of the iTClamp50 in~     the ambulance (pre-hospital) and emergency department setting. This will be accomplished by~     observing patients with the device applied from the pre-hospital through to patient~     discharge. The hypothesis is that the iTClamp50 will be safe and effective at providing~     temporary wound closure to control hemorrhage in the pre-hospital and emergency department~     setting.~   "
88929|NCT01893255|"~     This observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid~     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the~     approved label will be followed for 6 months.~   "
88930|NCT01893242|"~     This randomized, double-blind, placebo-controlled study will evaluate the potential of~     aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in~     patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be~     randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated~     time on study treatment is approximately 3 years.~   "
88931|NCT01893229|"~     Background:~      Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the~     population, and one of the leading causes of worldwide disability. Mania is a condition of~     excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of~     hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance~     treatment of acute mania with and without psychotic symptoms. Though clinical trails have~     been demonstrated that these drugs are individually more effective than placebo in the~     relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute~     mania urgently want to see the effectiveness, and psychiatrist under great pressure and are~     in great need to evaluate the very short-term effectiveness (e.g one week). If the first~     attempted antimanic drug fails, psychiatrist need the evidence that which medication should~     be to added on or switch to.~      Objectives:~      one main aim is to rank the short-term ( e.g.one and two week) effectiveness and~     acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine,~     Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to~     add on for non-responders or switch to.~      Methods:~      The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I~     disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric~     hospital in the history of China established by Dr.J. G. Kerr in 1898.~      Design:This study is a randomized, controlled trial. Participants with a Diagnostic and~     Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I~     disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium,~     Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following~     conditions, participants will take another antimanic drug as a combination medication: 1)~     those who have a reduction in YMRS scores less than 25% after one week of treatment; 2)~     those who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3)~     those who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine,~     Olanzapine, and Ziprasidone) will be added on for those who use lithium, Valproate or~     Oxcarbazepine as a first attempted medication; while Lithium, Valproate, or Oxcarbazepine~     will be added on for those who use an antipsychotic as a first attempted medication. Those~     participants who are recognized as non-response/partial response to two combined medications~     after 6 weeks of treatment will switch to Modified Electroconvulsive Therapy (MECT).~      Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS)~     and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI)~     Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief~     Psychiatric Rating Scale (BPRS).~      Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as~     non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of~     Clinical General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS~     as well as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as~     response. Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.~   "
88914|NCT01893450|"~     Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In~     most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At~     present, the treatment is directed to identify vision threatening which requires aggressive~     intervention, usually with glucocorticoids. For mild cases the treatment is limited to the~     normalization of hyperthyroidism and support measures. Preliminary data show that~     pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy~     by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte~     infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine~     and pentoxifylline on the clinical course and quality of life of patients with mild to~     moderate ophthalmopathy associated to Graves´disease.~      Methods. Patients with mild to moderate ophthalmopathy, with less than one year of~     evolution, and naive to treatment were randomized to receive treatment during 12 months with~     either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400~     mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They~     completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in~     the first and last visit the quality of life questionnaire specific for Graves'~     ophthalmopathy(GO-QOL) was applied.~   "
88915|NCT01893437|"~     This single-center, randomized, double-blind, placebo-controlled, single dose study will~     investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy~     volunteers.~   "
88916|NCT01893424|"~     This project is intended to evaluate self-emulsifying drug delivery system termed~     Piperine-Pro-Nano-Lipospheres (P-PNL) for enhancing the oral bioavailability of~     tetrahydrocannabinol (THC) and cannabidiol (CBD).The oral bioavailability of these~     cannabinoids is hampered by extensive first pass metabolism, resulting in relative~     bioavailability of 6%.~      The main goal of this study is to evaluate the bioequivalence of THC-CBD P-PNL product for~     oral administration to Sativex® buccal spray, as measured by AUC 0-24h, Tmax and Cmax.~   "
88917|NCT01893411|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with~     increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.~   "
88918|NCT01893398|"~     Our previous findings support the notion that group activity program, based on cognitive~     stimulation, recreational-occupational activities and physical-psychomotor exercises, can~     lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).~      The purpose of this study is to clarify the efficacy of a rehabilitation program in~     outpatients affected by AD in mild to moderate stages.~   "
88919|NCT01893385|"~     The main objective is to assess the variation in plasma levels of cathelicidin before and~     after influenza vaccination.~      All bibliographic data suggests that supplementation vitamin D in the elderly often~     deficient in this vitamin may have a double interest:~        -  By induction of cathelicidin, assist in anti-infective response in particular to the~          influenza virus~        -  The normalization of vitamin D status, promote the return to an appropriate immune~          response limiting excess inflammation and improving capacity to respond.~      The entire project will collect new information on the merits of the use of vitamin D in~     aging. A better knowledge of mechanisms involved and the impact of aging on them is a~     necessary prerequisite the definition of a new strategy using this drug in the elderly~     particularly fragile in order to improve its autonomy. This definition seems a sociological~     interest obvious economic knowing the current aging population and its impact future of our~     health system.~   "
88920|NCT01893372|"~     The goal of this clinical research study is to learn if eltrombopag can help to control MDS.~     The safety of this drug will also be studied.~   "
88921|NCT01893359|"~     The objectives of this study are to evaluate the safety and efficacy, with regards to~     regression of refractive outcome, as measured by manifest refraction spherical equivalent~     (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK~     followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin~     Ophthalmic Solution), as compared to LASIK alone.~   "
88922|NCT01893346|"~     To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in~     children from 3 months of age to <18 years.~   "
88923|NCT01893333|"~     To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize~     the complication of radical hysterectomy and to maximize quality of life and to evaluate the~     feasibility and efficacy by prospective randomized trial.~   "
88924|NCT01893320|"~     The goal of this clinical research study is to learn if the combination of vosaroxin and~     decitabine can help to control AML or MDS. The safety of these drugs will also be studied.~   "
88925|NCT01893307|"~     The goal of this clinical research study is to compare the side effects of 2 radiation~     treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy~     (IMRT) and intensity modulated proton therapy (IMPT). Participants may also receive~     chemotherapy along with radiation therapy.~      IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is~     designed to use beams of photon therapy to send radiation to the tumor. Both of these types~     of radiation treatment may give a full dose of radiation treatment to the tumor while not~     damaging as much of the healthy tissue around it.~   "
88926|NCT01893294|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in~     treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such~     as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
88927|NCT01893281|"~     This study will evaluate if testosterone solution can raise testosterone hormone levels into~     the normal range after treatment for up to 9 Weeks, in those participants with a documented~     history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)]~     when previously treated with a topical testosterone gel.~   "
88928|NCT01893268|"~     This prospective, observational study will assess the effectiveness and safety of Avastin~     (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small~     cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will~     be administered according to the treating physician. Data will be collected for~     approximately 4 years.~   "
88932|NCT01893216|"~     To investigate the prevalence of psychological symptoms and sexual dysfunction, and to~     estimate their possible interactions in infertile men.~   "
88933|NCT01893203|"~     The aim of the study is to compare the efficacy of two photosensitizers,~     methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the~     treatment of facial actinic keratosis. We use randomized, double-blinded prospective study~     design. The efficacy will be assessed clinically, histopathologically and~     immunohistochemically.~   "
88934|NCT01893190|"~     Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety,~     Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with~     Aneurysmal Subarachnoid Hemorrhage~   "
88935|NCT01893177|"~     The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014~     fulfills the EMA requirements for re-registration of influenza vaccines.~   "
88936|NCT01893164|"~     The purpose of this study is to determine which is the best surgery to treat different~     severity scales of cubital tunnel syndrome.~   "
88937|NCT01893151|"~     The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on~     synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and~     Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).~   "
88938|NCT01893138|"~     This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will~     evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived~     Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose~     in the treatment of stress urinary incontinence (SUI) in adult female patients.~   "
88939|NCT01893125|"~     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain~     experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after~     three weeks of treatment compared to the baseline period.~   "
88940|NCT01893112|"~     African American women account for 66% of HIV infections in women in the U.S., AIDS is a~     leading cause of death for African American women, and African Americans have the lowest~     medication adherence rates compared to other groups in the U.S. One of the reasons for low~     medication adherence among African Americans is fear of stigma. HIV stigma has been linked~     to depression, psychological distress, poor quality of life, poor medication adherence and~     service utilization contributing to morbidity and mortality. Research has found that stigma~     is a moderator to poor adherence via depressive symptoms.~      The current study is a randomized control trial with a time and attention control group to~     test the effectiveness of a stigma reduction intervention adapted for use with African~     American women. A total of 224 African American women will be recruited to participate in~     the study. Half of the women will be from Chicago, Illinois (112) and the other half will be~     from Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28~     women, half of the women will be in the intervention group (14) and the other half will be~     in the control group (14). Each study site will have 4 cohorts of 28 women.~      The main aims of the current study are:~        1. to determine the long-term effectiveness of the intervention to reduce stigma for~          African American women living with HIV in Chicago Illinois and Birmingham, Alabama~        2. to examine whether stigma reduction due to the intervention is associated with improved~          physical health biomarkers (CD4+ T cell count, viral load), mediated by reduced~          psychological symptoms (depressive symptoms), improved engagement to care, and improved~          medication adherence~        3. to explore whether stigma reduction due to the intervention is moderated by location~          (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived~          social support~      We expect that the multimedia workshop intervention will demonstrate effectiveness in~     reducing internalized stigma through an easily-disseminated method, and that it will have a~     positive impact on medication adherence and engagement in care for African American women~     living with HIV.~   "
88941|NCT01893099|"~     The best way to combine a loco-regional procedure such as chemoembolisation or~     radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial~     aims to establish, first, the tolerability of the combination of liver radioembolization~     with SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying~     different schedules of administration of sorafenib after and before radioembolization.~     Secondly, we aim to evaluate angiogenic markers modifications during these different~     schedules, either in the serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and~     the timing of introduction will differ for one cohort to the other, given after the~     radioembolization for initials cohorts and finally, before and concomitantly to~     radioembolization for the last cohort.~   "
88942|NCT01893086|"~     Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic~     salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign~     disease. However, the safety and the consequences regarding ovarian function after~     salpingectomy have not yet to be established. Therefore, the aim of this randomized~     controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between~     laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.~   "
88943|NCT01893073|"~     The purpose of this study is to determine whether a mindful walking program is effective in~     the treatment of patients with chronic low back pain.~   "
88944|NCT01893060|"~     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care~     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can~     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).~     This study is a prospective, randomized controlled feasibility trial to evaluate three types~     of hygiene products on umbilical line stumps, on the effect of line colonization and~     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be~     randomized into one of four study groups, three products against standard of care (no~     product). The three products that will be evaluated are currently being used in different~     capacities for skin care in the University of Virginia (UVA) NICU. The study hypothesizes~     that twice daily topical application of 1 or more antiseptic to the top of the umbilical~     stump will decrease colonization of the umbilical stump while umbilical lines are in place.~   "
88945|NCT01893047|"~     A mother of a preterm infant listening to music while pumping her breasts will produce more~     milk than a similar mother who is not listening to music. A mother listening to live music~     will produce more milk than a mother listening to recorded music~   "
88946|NCT01893034|"~     Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone~     results in the abutment of the femoral neck against the rim of the acetabulum. This gives~     rise to localised cartilage damage and pain, but also increases the risk of developing~     osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic~     surgery versus physiotherapy and activity modification for the treatment of this condition.~   "
88947|NCT01893021|"~     The purpose of this study is to understand the family planning needs and practices of~     postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).~      Hypotheses:~        1. Postpartum women who are older, who have a history of unintended pregnancy, who do not~          desire another child within 2 years, and who were counseled about LARC during their~          pregnancy are more likely to have interest in using LARC.~        2. Postpartum women who are older are more likely to be aware of LARC methods.~        3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum~          Malawian women who are HIV-.~   "
88949|NCT01892995|"~     This study will enroll patients presenting to the emergency department with acute suicidal~     ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of~     three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control).~     Serial measurements will be made in the ED and at follow-up intervals.~   "
88950|NCT01892982|"~     The investigators' goal is to optimize the developmental outcomes of preterm infants by~     preventing depression and improving functioning among their mothers during the critical~     first year of life. The investigators are conducting a randomized controlled trial of a~     replicable, lay-delivered intervention - the basic approach of which is to use an~     empirically-supported, cognitive behavioral strategy to help mothers solve their unique~     daily problems and address some of the predictable challenges to parenting a preterm infant.~   "
88951|NCT01892969|"~     Project Summary We propose an ancillary study to The Heart and Lung Failure Pediatric~     Insulin Titration trial (HALF PINT), which is investigating the impact of normalizing blood~     glucose using insulin infusions on clinical outcomes among children with hyperglycemia and~     heart and lung failure. In this ancillary study, we will measure plasma levels of~     inflammatory, coagulation, and fibrinolysis proteins and genotype DNA for polymorphisms~     among patients enrolled in the HALF PINT trial. The results from this ancillary study will~     help us to understand potential mechanisms through which normalizing blood glucose provides~     benefit, which may lead to development of new therapeutic strategies in critically ill~     children~   "
88952|NCT01892956|"~     Categorization of glucose levels into 'healthy', 'pre-diabetic' or 'diabetic' is~     increasingly seen as artificial. Furthermore, most micro and macrovascular complications may~     be present already at the pre-diabetic stage.~      Hyperglycemia, pre-diabetes and impaired glucose tolerance (IGT) are fully reversible, thus,~     maintaining normal blood sugar levels is crucial for the prevention and control of diabetes~     and the various other consequences of the metabolic syndrome. Only interventions that are~     individually tailored can achieve proper glycemic control, and the glycemic index (GI),~     which quantifies the glycemic response to particular foods, was developed for this purpose.~      In this study the investigators will characterize the blood glucose responses and microbiota~     of healthy individuals, aiming to assess the influence of food intake on gut microbiota and~     the influence of gut microbiota on glycemic responses.~   "
88953|NCT01892943|"~     The objective of this survey is to establish the clinical course of vision loss and recovery~     in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy~     (LHON).~      Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be~     the main endpoint analysed.~      The survey will collect historically documented visual acuity data for all patients at~     participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria~     apply. Patients are not required to attend the clinic for the survey.~      Data will be collected in a completely anonymous manner. Ethical approvals and data release~     agreements will be obtained as required by local regulations.~   "
88954|NCT01892930|"~     This pilot clinical trial studies stereotactic body radiation therapy in treating patients~     with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
88955|NCT01892917|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES)~   "
88956|NCT01892904|"~     The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative~     study (24-week treatment period).~      The objective of this study is to prove the superiority of BAY 86-5300 with flexible~     extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in~     terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of~     evaluation period.~      In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients~     treated for one year will be investigated.~   "
88957|NCT01892891|"~     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and~     tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to~     receive either a placebo or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days~     in a row.~   "
88958|NCT01892878|"~     The purpose of this clinical study is to evaluate fusion of the facet joints in a~     prospective cohort of patients utilizing the VerteLoc facet fixation device in patients~     receiving lumbar laminectomy (L1-S1), without ancillary stabilization devices such as~     pedicle and transfacet screws.~   "
88959|NCT01892865|"~     This study compares two different methodologies of scheduling cases in the operating room.~   "
88960|NCT01892852|"~     The purpose of this study is to evaluate whether acupuncture can be effective for~     chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.~   "
88961|NCT01892839|"~     Hemodialysis keeps patients with renal failure alive but does not restore normal health.~     Retention of chemicals that bind to plasma proteins and are therefore poorly removed by~     dialysis may contribute to ill health in patients receiving conventional treatment. This~     proposal will test the effect of a new method designed to improve the removal of~     protein-bound solutes during dialysis. The effects on blood chemical levels of two different~     dialysis prescriptions will be tested in patients already undergoing nocturnal in-center~     hemodialysis three times weekly.~   "
88962|NCT01892826|"~     The rational of the study is to assess the pregnancy rate after the transfer of frozen~     blastocyst in natural cycle controlled by external administration of hCG.~   "
88963|NCT01892813|"~     The project is designed to examine the effectiveness of strategies to increase access to~     treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will~     examine whether tailored treatment that is designed to address common comorbid conditions~     that are related to cigarette smoking enhances success with quitting relative to enhanced~     standard of care. The investigators hypothesize that participants assigned to the tailored~     tobacco cessation intervention will report greater cessation rates at six months. The~     investigators also anticipate more favorable outcomes on measures of depressive symptoms,~     alcohol use, and body weight.~   "
88964|NCT01892800|"~     The purpose of this study is explore the impact of lung cancer surgery on the function of~     the right side of the heart.~   "
88965|NCT01892787|"~     The airways in the lungs get smaller the further into the lungs they go. Most simple~     measurements of lung function only reflect the larger 'central' airways and do not provide~     information on the smaller 'peripheral' airways. Newer measurements have been developed that~     can now give us accurate information on how the smaller airways are working. Indeed the~     small airways seem to play a significant role in asthma in terms of inflammation and airway~     narrowing. Recently, new types of inhaler formulations have been developed that have a much~     smaller particle size than other standard formulations. These formulations have been shown~     to go further into the lungs, thus getting into the smaller airways. In this study we aim to~     compare the two extremes of available long acting beta agonists in terms of particle size~     i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in~     asthmatics with abnormal small airway function using a breathing test called impulse~     oscillometry. By using this test we will be able to find out whether using an extrafine~     particle inhaler improves small airway function.~   "
88966|NCT01892774|"~     This study would assess the impact of radio-frequency catheter ablation on exercise capacity~     and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients~   "
88967|NCT01892761|"~     Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney~     transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to~     post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to~     tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the~     full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days~     7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per~     protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period~     in both groups but profiles were different according to the CNI regimen and time. The~     majority of patients were underexposed to MPA on day 7 for both groups what reinforces the~     need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL~     group, after day 7, due to both a diminished MPA clearance (for both groups) and higher~     AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at~     day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA~     monitoring and dose correction for long-term follow-up. These PK data suggest that changes~     in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be~     mandatory at specific time-points.~   "
88968|NCT01892748|"~     The potential role of vitamin D on disease susceptibility, activity and severity has been~     considered for several autoimmune rheumatologic diseases include systemic lupus~     erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE~     patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).~      The objective of this study is to evaluate the effect of vitamin D supplementation~     (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity~     (clinical and laboratory parameters), fatigue and bone mass.~   "
88969|NCT01892722|"~     To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pedaitric~     patients with multiple sclerosis~   "
88970|NCT01892709|"~     This is an exploratory, hypothesis-generating safety and efficacy study for patients who~     come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic~     pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV~     hydromorphone over a 4 hour period. Hydromorphone will be given as 1 mg increments based on~     how the patient responds to the question, Do you want more pain medicine?. This question~     will be asked repeatedly 30 minutes after the patient answers no or 30 minutes after the~     most recent dose of IV hydromorphone (which occurs if the patient answers yes). Up to 10%~     (approximately 30 patients) will serve as a pilot at the start of the study.~   "
88971|NCT01892696|"~     The clinical usefulness of inspiratory flow pattern manipulation during mechanical~     ventilation remains unclear. The aim of this study was to investigate the effects of~     different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in~     mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and~     inferior vena cava distensibility.~   "
88972|NCT01892683|"~     This trial investigates the relationship between concentrations of the anesthetic drug~     propofol in exhaled breath and blood in patients undergoing general anesthesia for elective~     surgery. The main goal of this study is to develop a population pharmacokinetic model for~     propofol in exhaled breath.~   "
88973|NCT01892670|"~     In a combat situation the need for safe and high-quality blood products is increasing. WB~     (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is~     an even better whole blood product.~      The purpose of this study is to examine the quality of leucoreduced, cold-stored whole~     blood. We also wish to examine the effects of filtration of whole blood without a 1-2 hour~     holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore~     the possibility of using cold-stored WB for production of RCC.~      Analyses are performed with a main focus to investigate function and quality of red blood~     cells and platelets.~   "
88974|NCT01892657|"~     This study examined the possible sensitization and irritation effects of a moisturizer with~     sunscreen SPF 50+.~   "
88975|NCT01892644|"~     Hypothesis: Deferasirox can be used as a therapeutic agent to deplete the liver, heart and~     bone marrow of excess iron in patients with iron overload caused by myelodysplastic syndrome~     (MDS) and hemochromatosis (HC.~      Assess the effect of new serum biomarkers (NTBI and hepcidin) and MRI as indicators of iron~     overload and their usefulness to monitor iron depletion treatment.~      Study the effect of iron overload and iron depletion on intracellular signal transduction,~     trace metals concentrations in serum and urine and markers of oxidative stress in blood~     cells and urine.~   "
88984|NCT01892527|"~     This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with~     advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of~     systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab).~      This trial will be conducted to determine objective response rate (ORR), progression-free~     survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with~     wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or~     panitumumab) and shows overexpression of cMET.~   "
88976|NCT01892631|"~     Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the~     UK as a whole. Influenza vaccine is safe and effective but is required annually because the~     circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer~     (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65~     with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should~     be vaccinated. While primary care practices are achieving these targets for elderly~     patients, those set for younger patients with chronic conditions are not being met, with a~     third of patients being missed in the 2011/12 flu season and with no substantial~     improvements in uptake in the past decade. Therefore strategies to increase flu vaccine~     uptake in these patients are required.~      Previous trials have shown that patient reminders can increase vaccine uptake and in~     particular, text messaging has shown to work in some populations in the United States as a~     cheap, simple and effective reminder. However, whether the same is true in UK general~     practice is unclear. The use of text messaging in the NHS for appointment reminders is also~     increasing as it is cheap, quick and effective. Text messaging is already used in roughly~     30% of practices to remind patients about their flu vaccine but there has been no trial~     addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine~     reminder in patients aged under 65 who have a chronic condition. We hypothesise that~     practices that send a text message will have increased flu vaccine uptake.~   "
88977|NCT01892618|"~     The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia~     (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine,~     Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms~     of immune response.~   "
88978|NCT01892605|"~     Music has a long history in healing physical and mental illness. The Mozart effect was~     initially reported by Rauscher, Shaw, and Ky in the journal of Nature in the year of 1993.~     They examined performance on Stanford-Binet spatial tasks immediately following either 10~     minutes of listening to Mozart's sonata K.448, silence, or instruction to relax. They found~     the performance scores were 9 point higher in Mozart-listening group than other two groups.~     Later, the beneficial influence of Mozart music on parkinson's disease, epilepsy, senile~     dementia, and attention-deficit/hyperactivity disorder was reported. However, the real~     neurophysiological mechanism of the influence remains unclear.~      Epilepsy is a common disorder in the field of pediatric neurology. Although we had greatly~     advanced in develop of new anticonvulsant, thirty percent of patients with epilepsy have~     drug-resistance, which is associated with an increased risk of debilitating psychosocial~     consequences. In addition, the adverse effects of anticonvulsants are not uncommon. Few~     reports demonstrated that patients exposed to Mozart's music can significantly decrease in~     seizure frequencies and interictal epileptiform discharge. However, the case number of these~     studies was limited and the mechanisms of music therapy on epilepsy were not well known. In~     our recent studies, Mozart's music indeed decreased the epileptifrom discharge in the~     patients with epilepsy, particularly in the patients with generalized discharge and central~     discharge. On the basis of these encouraging results, we will try to investigate the neural~     mechanisms and clinical applications of music therapy in the following three years.~      In the first year of our study, we use animal model to examine the possible mechanism of~     Mozart's effect. The aim of the second year study is investigation the effect of music on~     the cortical functions in the epileptic rat model. According to our previous study, Mozart's~     sonata K.448 was effective in reducing epileptiform discharge. On the basis of previous~     two-year results, the patients with epilepsy will be enrolled in the third year project to~     perform an individualized music therapy. In this study, we can provide an alternative~     therapy in the patients of epilepsy and investigate the possible biological mechanism of~     music effect.~   "
88979|NCT01892592|"~     The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and~     to reduce racial disparity in HTN control. To accomplish this, the investigators propose to~     perform a cluster randomized controlled trial at the primary care provider (PCP) level and~     including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the~     HTN registry of which approximately 15,000 are black. The investigators will randomize all~     PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally~     tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with~     pharmacotherapy. The Shake, Rattle and Roll trial is named for: 1) shake the salt habit;~     2) rattle the intensity of current BP management; and 3) design the interventions with the~     goal of being able to adapt and roll them out to community clinics outside of a managed~     care system. Primary research question: whether a primary prevention intervention of either~     diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than~     usual care in improving rates of HTN control in blacks and thereby reducing disparities~     between black and white. Primary aim: By implementing either intervention, the investigators~     will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1~     year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching~     intervention or an intensified BP management protocol will result in an increase in HTN~     control rate compared to usual care. Primary outcome: the proportion of patients with~     sustained BP control at 1 year post-study enrollment.~   "
88980|NCT01892579|"~     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and~     irreversible neurodegenerative condition, affecting also close to 15 million family~     caregivers (CG). A hallmark of the disease and one of the most significant challenges in~     dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling~     and frequently occurring. It is associated with increased health care costs, reduced life~     quality, heightened caregiver burden, disease acceleration and nursing home placement.~     Treatment typically involves pharmacologic agents; however, these are at best modestly~     effective, carry serious risks including mortality, and may not reduce family distress.~     Recently issued position statements from medical organizations suggest nonpharmacologic~     strategies as first-line treatment. Nevertheless, nonpharmacological strategies for~     agitation remain understudied. We propose a Phase III efficacy trial to test a novel~     8-session patient-centric intervention, the Tailored Activity Program. We will test the~     program using a randomized two-group parallel design of 250 people with dementia (PwD) and~     their CGs (dyads) who will be randomly assigned to received a program of tailored activities~     or a control intervention of equivalent in-home attention and social contact. The trial~     assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home~     environment from which activities are developed to match PwD profiles. Families are trained~     to implement activities and modify them for future decline. Our primary study aim evaluates~     the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored~     activity program will have less frequent agitation compared to the control intervention~     condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on~     agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will~     manifest lower severity scores at 6 months and better quality of life compared to PwD in the~     control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG~     wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring~     activities will report enhanced wellbeing and less time caregiving compared to the control~     intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program~     expressed as an incremental cost outcome achieved in the form of CG burden reductions and~     willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities~     will be cost effective compared to the control intervention at each test occasion).~     Exploratory aims will evaluate treatment effects on psychotropic medication use and other~     troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored~     activity program will use activities at 6 months and with what frequency, how time gained is~     spent, and if frequency/duration of treatment and activity use affects outcomes. If proven~     efficacious and cost effective, the Tailored Activity Program has potential to transform~     clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at~     home. This trial addresses a critical clinical need and public health priority identified by~     recent legislative activity.~   "
88981|NCT01892566|"~     Investigators propose to develop methods to improve early identification of acute~     exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize~     that earlier identification of acute exacerbations through in-home monitoring of respiratory~     symptoms, lung function and medication usage will allow appropriate intervention to reduce~     the morbidity associated with AECOPD. Therefore, the investigators propose using innovative~     mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV~     (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly~     under-recognized among HIV-infected persons. In this application, among HIV-infected~     individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized~     trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden~     of AECOPD.~   "
88982|NCT01892553|"~     Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated~     symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify~     brain activation has shown good efficacy in the treatment of pain especially in the clinical~     context. Given the fact that dyspnea has many common characteristics with pain, especially~     concerning the brain areas involved in its central processing, we hypothesize that tDCS may~     also modify the perception of dyspnea. In order to test this, we first shall determine~     whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In~     case of promising results of this pilot study, the next step will be the evaluation of the~     benefit of tDCS in patients with severe dyspnea.~   "
88983|NCT01892540|"~     This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or~     PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical~     imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or~     PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing~     clinical imaging or with newly diagnosed breast cancer.~   "
88985|NCT01892514|"~     Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new~     United States of America cases) characterized by ischemic cell necrosis in a hip proximal~     epiphysis area frequently requiring total Hip Arthroplasty (THA).~      Even though THA resolves symptoms and restores good joint function, young patients are prone~     to major disabilities and require prosthesis revision surgeries.~      In this clinical trial a comparison between two groups of patients, treated with the same~     procedure but with two different regenerative techniques, will be performed:~        1. 52 patients with necrosis in an early stage, without deformity of the femoral epiphysis~          (stage 2A-B-C in Association for Research on Osseous Circulation (ARCO) classification,~          will undergo wide decompression of the necrotic area and reconstruction with homologous~          Lyophilized Bone Chips (LBC), growth factors from platelet concentrate Platelet-Rich~          Fibrin (PRF) and Concentrated Bone Marrow (CBM).~        2. 52 patients with necrosis of similar features, without deformity of the femoral~          epiphysis, will undergo wide decompression of the necrotic area and reconstruction with~          Demineralized Bone Matrix (DBM), growth factors from Platelet-Rich-Fibrin (PRF) and~          Concentrated Bone Marrow (CBM).~      Patients will be evaluated post-surgery at 6 weeks, 3, 6, 12, and 24 months to assess joint~     damage evolution by ARCO classification, and hip function by clinical scores (Harris Hip~     Score (HHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score, and~     Visual Analogic Scale (VAS)).~   "
88986|NCT01892501|"~     Impact of screening nodes mediastinal by PET, at different times of the management of cancer~     disease, remain unclear.~      Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent~     therapeutic management should be evaluated in these different contexts.~      We would like to demonstrate the clinical utility of this association to replace more~     invasive diagnostic procedures and to assess the impact of the puncture on a possible~     modification of the therapeutic management.~      It is a single center prospective diagnostic assessment~   "
88987|NCT01892488|"~     The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the~     development of antibiotic resistance in the community. The primary objective of ABACOPD is~     to demonstrate in a sufficiently sized clinical study that there is no relevant increase in~     the failure-rate for patients with acute moderate exacerbations of COPD (AE-COPD) treated~     with placebo instead of antibiotic treatment both on top of standard of care. A patient is~     classified as treatment failure if additional antibiotic therapy is required during~     treatment period or until the test of cure visit (TOC at day 30, primary endpoint).~   "
88988|NCT01892475|"~     The purpose of this study is to test the overall effects of incentives on physical activity~     among older taxi drivers, and whether mental accounting exists in this context.~   "
88989|NCT01892462|"~     The purpose of this study is to determine whether levels of inflammatory markers in~     circulating blood can correlate with risk for dangerous heart rhythms. Patients with~     systolic heart failure, which has been shown to increase risk for dangerous heart rhythms,~     will be enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in~     place, which allows regular evaluation of heart rhythm.~   "
88990|NCT01892449|"~     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous~     studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics~     and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E~     ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing~     robot-assisted laparoscopic radical prostatectomy.~   "
88991|NCT01892436|"~     This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It~     aims to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for~     subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,~     safety and tolerability information in subjects with active psoriatic arthritis receiving~     secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects will~     complete the assessments associated with the core study visit and will subsequently continue~     in the extension study on the same dose that they were receiving during the core study. The~     regular assessments of disease activity will ensure that subjects who are experiencing~     worsening of disease in any of the treatment groups can exit the study upon their own wish~     or based on the advice of the investigator at any time.~   "
88992|NCT01892423|"~     Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion~     Daily Advance to induce sensitization to the skin~   "
88993|NCT01892410|"~     Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer~     or irritant in certain individuals.~   "
88994|NCT01892397|"~     The purpose of this study is to find out what effects, good or bad, the Optune device has on~     the patient and meningioma. This study is being done because currently there are no proven~     effective medical treatments for a progressive meningioma that has failed surgery and/or~     radiation. The study uses an experimental device called Optune. Optune is experimental~     because it has not been approved by the U.S. Food and Drug Administration (FDA) for this~     type of tumor, although it has been approved for a different type of brain tumor.~   "
88995|NCT01892384|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in schizophrenic patients following oral administration of multiple low, medium,~     and high doses over 14 days.~      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI~     409306 in schizophrenic patients.~   "
88996|NCT01892371|"~     The goal of the Phase 1 part of this clinical research study is to find the highest~     tolerable dose of AC220 (quizartinib) that can be given with either 5-azacitidine~     (azacitidine) or cytarabine to patients with AML or MDS.~      The goal of the Phase 2 part of the study is to learn if quizartinib with either azacitidine~     or cytarabine can help to control AML or MDS. The safety of these combinations will also be~     studied.~   "
89012|NCT01892163|"~     Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg~     Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical~     coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular~     edema.~   "
89013|NCT01892150|"~     Anti-inflammatory and anti-oxidant agents have become the important ingredients in~     sunscreen. However, there is no histologic study about the effects of anti-inflammatory and~     anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.~   "
88997|NCT01892358|"~     We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an~     assessment-only condition (both groups receive rapid HIV testing, a review of testing~     results, and brief HIV prevention counseling) among 350 injection drug users recruited~     during an acute medical hospitalization at Boston Medical Center. In the general hospital~     setting, injection drug users who otherwise might not seek care are accessible and~     teachable, and the presence of a drug-related illness can set the stage for patients to be~     more receptive to interventions2. We hypothesize that the Skin intervention will produce~     better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.~   "
88998|NCT01892345|"~     The primary objective of the study is to assess the efficacy and safety of eculizumab~     treatment as compared to placebo in relapsing NMO patients using a time to first relapse~     study design.~   "
88999|NCT01892332|"~     Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery~     because of its rapid onset. But the epidural anesthesia using high concentration of~     lidocaine may cause excessive motor block and unwanted side effects such as nausea, vomiting~     and hypotension.~      This is a study to determine the effective concentration of lidocaine with fentanyl in~     lumbar epidural anesthesia for transurethral resection of prostate in elderly patients.~   "
89000|NCT01892319|"~     This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy~     Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with~     diabetes mellitus.~   "
89001|NCT01892306|"~     The specific goal of this research study is to investigate the feasibility, acceptability,~     and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed~     specifically to target common core processes across mood and anxiety disorders [Unified~     Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of~     patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare~     treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with~     the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month~     period and will be assessed monthly to track changes in mood, anxiety and emotion-related~     symptoms; functional impairment; and relapse rates. Data on the acceptability of the~     treatment will be gathered concurrently through monthly patient self-reported ratings of~     treatment satisfaction, and by tracking rates of acceptance for randomization into the~     study, number of completed sessions, and dropout rates. The study will examine: 1) whether~     combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an~     acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and~     comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads~     to greater symptom reduction and reduced functional impairment than pharmacotherapy alone,~     3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse~     rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms,~     relapse rates, and functional impairment are mediated by changes in emotion regulation~     skills. The broader aim of this study is to address the need for improved treatments for~     bipolar disorder.~   "
89002|NCT01892293|"~     This study will enroll patients with multiple myeloma who have received prior therapy for~     their disease but their disease has progressed or relapsed.~   "
89003|NCT01892280|"~     The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set~     of psychoeducational materials for teens with type 1 diabetes and (2) text message reminders~     to check blood glucose levels can help improve blood glucose levels in teens with type 1~     diabetes.~   "
89004|NCT01892267|"~     Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube~     (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration~     rate, and lower rates of short- and long-term complications when compared to standard PEGJ~     feeding tubes.~   "
89005|NCT01892254|"~     This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS)~     before and after removal of their insulin resistance by metformin.~      The investigators' hypothesis is that insulin resistant women with PCOS have a reduced~     incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance~     test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be~     improved when their insulin resistance is removed.~   "
89006|NCT01892241|"~     Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept~     peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.~   "
89007|NCT01892228|"~     The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to~     decrease mortality related to HIV.~      The study's proposed mechanism of decreasing mortality rates is to shorten the time between~     initial HIV screening and ART implementation to within two weeks.~      The study population consists of participants who received an initial HIV infection~     diagnosis within the study period. Medical institutions will provide one-stop services by~     following detailed guidelines regarding reporting of positive HIV antibody screenings,~     further testing procedures, and treatment referrals in accordance with a pre-determined~     timetable. In addition, additional strategies focusing on policy development, medical~     personnel training, and a broad general public education campaign will be implemented.~      Main assessment measures are HIV-related mortality rates, treatment coverage, or other~     health outcomes.~   "
89008|NCT01892215|"~     Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because~     of the increase in the rate of cesarean section, any procedure that could help reduce blood~     loss during cesarean section should be investigated. The purpose of this study was to~     compare 2 methods of blunt expansion of the uterine incision at the time of cesarean~     delivery: transversal vs. cephalad-caudad.~   "
89009|NCT01892202|"~     This multicenter observational study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on~     dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic~     renal anemia according to the standard of care and in line with the current local label will~     be followed for 6 months.~   "
89010|NCT01892189|"~     The purpose of this study is to determine whether ketamine-induced brain activity changes~     are modulated by TAK-063 administration using neuroimaging battery tests.~   "
89011|NCT01892176|"~     The investigators hypothesise that measuring biomarkers of oxidative damage could better~     inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD~     subjects.~   "
89016|NCT01892111|"~     Obese women experience increased infertility rate and longer time to conception showing~     lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight~     loss improves not only spontaneous pregnancy rates but also those of assisted reproductive~     techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle~     intervention programs consisting in hypocaloric diet and increased physical activity,~     whereas very little is known about the specific effects of physical activity alone on human~     reproduction.~      In a previous retrospective study, we demonstrated that physical activity enhances the~     reproductive performance of obese infertile patients who receive in vitro fertilization~     (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.~      The aim of this randomized controlled trial (RCT) will be to evaluate if a structured~     exercise program improve the effectiveness of ARTs.~   "
89017|NCT01892098|"~     The purpose of the study is to determine the effects of zinc supplementation on bone growth~     over four weeks. Participants will agree to attend two visits to our laboratory and at each~     will complete blood and urine samples, questionnaires related to diet and physical activity~     and will receive a bone scan at the first appointment.~   "
89018|NCT01892085|"~     Compelling evidence exists that breast milk helps protect very premature infants from~     prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit~     delayed lactogenesis stage II (when the milk comes in) and decreased breast milk~     production. Several studies have linked earlier initiation of breast milk expression~     following delivery with a greater milk production. However, none conclusively determined the~     optimal timing of breast milk expression. As a result these mothers continue to struggle~     with inadequate breast milk production. This study will follow 180 mothers of premature~     infants for 6 weeks following delivery to test~      Earlier initiation of breast milk expression following delivery is associated with (1) an~     earlier lactogenesis stage II, (2) greater volume of breast milk production during the first~     6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an~     earlier gestation will have decreased milk production and a later lactogenesis stage II.~     Following stratification according to the gestational age of the infant (23-27 weeks vs.~     28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed~     to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6~     hours following delivery. The timing of lactogenesis stage II will be documented, and the~     volume of breast milk produced will continue to be measured for the first 6 weeks following~     delivery and at discharge. Infant nutritional outcomes will be measured throughout the~     6-week study. The impact of the differences in timing of initiation of milk expression~     following delivery on timing of lactogenesis stage II, milk volume, short term nutritional~     outcomes, amount of breast milk feedings at discharge, and impact of gestational age on milk~     volume and lactogenesis stage II will be determined.~   "
89019|NCT01892072|"~     The investigators study the VEGF signaling in HCC cell lines and its mechanism in HCC~     growth, proliferation and apoptosis.~   "
89020|NCT01892059|"~     The purpose of this study is to compare the efficacy and safety of the segmental artery~     clamping and main renal artery clamping during laparoscopic partial nephrectomy~   "
89021|NCT01892046|"~     Heat shock protein 90 (Hsp90) is a chemical in the body that is involve in the promotion of~     cancer. SNX-5422 is an experimental drug that blocks Hsp90.~   "
89022|NCT01892033|"~     The overall aim of this pilot feasibility study is to determine if 12-week moderate~     intensity exercise can safely alleviate posttraumatic symptoms in premenopausal women~     veterans.~      Specific aims of the study are to;~        1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity~          exercise~        2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome~          data will include posttraumatic and depressive symptoms.~        3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on~          comorbid pain syndrome and quality of life.~   "
89023|NCT01892020|"~     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and~     safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50~     (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2~     diabetes mellitus.~   "
89024|NCT01892007|"~     A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive)~     working memory training results in improvements in untrained measures of cognition, speech~     perception and self-reported hearing abilities in older adults (50-74 years) with~     mild-moderate hearing loss who are existing hearing aid users, compared with an active~     placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained~     Cogmed tasks, representing increased working memory capacity, will result in improved~     performance on cognitive and speech perception tasks that engage working memory. We also~     measure self-reported hearing ability to assess self-perceived benefit of Cogmed training.~   "
89025|NCT01891994|"~     Background:~      - Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help~     improve blood counts in these patients. However, researchers do not know how long the drug~     can and should be taken for this type of anemia.~      Objectives:~      - To look at whether 6 months of treatment with eltrombopag can improve patient s blood~     counts.~      Eligibility:~      - Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia.~      Design:~        -  Participants will take eltrombopag by mouth once a day for 6 months.~        -  Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow~          samples will be collected at 3 and 6 months. These samples will look at the effects of~          the study drug on the marrow.~        -  Participants will continue to take the study drug for as long as it is effective and if~          the side effects are not severe.~   "
89026|NCT01891981|"~     The goal of this clinical research study is to find the highest tolerable dose of~     moxetumomab pasudotox that can be given to patients with relapsed and/or refractory ALL.~   "
89027|NCT01891968|"~     The goal of this clinical research study is to learn if bortezomib can help to control MDS.~     The safety of this drug will also be studied.~      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer~     cells to die.~   "
89028|NCT01891955|"~     The purpose of this study is to compare two healthy diets (according to official Spanish~     guidelines) that have been shown to be effective in the treatment of type 2 diabetes in~     order to see if one is better than the other.~      Another goal is to test the hypothesis that food choice has metabolic effects that are~     independent of macro/micronutrient composition, fiber content, glycemic load and weight loss~     in the treatment of type 2 diabetes.~   "
89029|NCT01891942|"~     The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw~     Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger~     threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold~     for healthy subjects and COPD patients.~   "
89140|NCT01890499|"~     Prospective randomized controlled trial investigating commencement of low residue diet~     versus clear feeds on postoperative day one following elective colorectal surgery, with~     regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative~     length of hospitalization stay.~   "
89030|NCT01891929|"~     This study, driven on schizophrenic patients, is aimed at :~        1. Measuring the efficiency of the cognitive remediation program RECOS (COgnitive~          REmediation in Schizophrenia) on the capacity of the patients suffering from~          schizophrenia to improve the integration in sheltered employment (ESAT and EA).~        2. Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to~          the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on~          integration in sheltered employment of patients suffering from schizophrenia.~        3. Realizing a comparative analysis, in both arms, of :~             1. the number of working hours achieved in sheltered environment during the 6 months~               following the two programs (reported to the working time planned by the contract~               of employment)~             2. the duration of such employments in sheltered areas.~        4. Estimating the impact of RECOS on the neuropsychological variables, the symptomatology,~          the consciousness of the disorders(insight), the quality of life and the social~          autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6~          months later (month M9), and looking for a correlation between the improvement of these~          parameters and sheltered employment.~        5. Estimating the impact of cognitive remediation on integration in sheltered employment.~   "
89031|NCT01891916|"~     Food allergy (FA), defined as an adverse immune response to food allergens, is among the~     most frequent allergic disorders in childhood and it has recognized as a major paediatric~     health problem due to the severity of the reactions and the dramatic increase over the past~     decades. Cow's milk allergy (CMA) is the most frequent FA in children worldwide, and it has~     been demonstrated that it could be the first manifestation of the so-called atopic march,~     characterized by the occurrence of other allergic disorders in the subsequent years after~     the onset of CMA. In a previous study, involving children with CMA over a period of 5 years,~     40% developed asthma, 21% atopic eczema, and 43% allergic rhinitis. Similar results have~     been reported in a recent study on Finnish children Intestinal microflora appears to have a~     crucial role in the development of atopic disorders. Children with atopic diseases have~     different commensal bacterial groups in the gut compared to non-atopic children, and~     differences are also found between countries with high and low incidence of atopic diseases.~     There is currently great interest in manipulating the normal microbiota to accrue health~     benefits through an approach known as probiotics. Probiotics are defined as live~     microorganisms which when administered in adequate amounts confer a health benefit on the~     host. The conceptual basis of possible use of probiotics in the prevention and treatment of~     atopic disorders is well grounded. Lactobacillus GG (LGG) is the most studied probiotic in~     the prevention and treatment of atopic disorders. Wide and well-designed clinical studies~     have provided several evidences on the efficacy of LGG as preventive or therapeutic strategy~     in pediatric atopic disorders. More recently, in vitro studies have provided evidences on~     the potent immunoregulatory role and on the influence on intestinal microflora composition~     (toward a more beneficial composition in the prevention and treatment of atopic disorders)~     elicited by LGG. This view has been further reinforced by recent research showing that LGG~     is able to improve recovery of intestinal symptoms in infants with CMA-induced allergic~     colitis.~   "
89032|NCT01891903|"~     TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO~     SPANISH~   "
89033|NCT01891890|"~     Seizures that arise in specific areas in the brain are called Localization Related Epilepsy~     (LRE) and are the most common seizure disorder in children. Children that receive drug~     treatment for this disorder may suffer from treatment related side effects which impact~     their ability to think or concentrate and their ability to interact socially. These negative~     treatment effects can impact the child's performance in school and long term may impact~     employment and job options.~      This study will determine whether changes in attention and social interactions are seen in~     children treated for LRE using three of the most common medications used to treat pediatric~     LRE. Children who are newly diagnosed with LRE by their doctors and are between 6-12 years~     of age will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine.~      There will be 12 study sites throughout the US. Children will undergo evaluation of their~     thinking and ability to pay attention before and after starting drug treatment for LRE.~     Regardless of the specific findings, results of this study will provide the information~     needed to help parents and their clinicians choose treatment options that maximize cognitive~     abilities in children with LRE, and provide the data needed for practice guidelines to be~     established on the basis of cognitive side effect risks.~   "
89034|NCT01891877|"~     This study will look at the five different types of sickle cell and their relation to~     self-reported ill health to determine whether or not one or two of the sickle cell~     haplotypes are correlated with worse health outcomes. Participants can do complete the study~     in under half an hour in the privacy of their own home.~   "
89035|NCT01891864|"~     The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in~     patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75~     response rate at Week 12.~   "
89036|NCT01891851|"~     The purpose of this study is to evaluate the drug-drug interaction between steady-state~     concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the~     multiple dosing regimen and to explore the short term safety and tolerability of multiple~     doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.~   "
89037|NCT01891838|"~     The risk of bleeding is important during transsphenoidal surgery. This study aims to find if~     the ventilation mode, controlled pressure and controlled volume, modifies the risk of~     bleeding.~   "
89038|NCT01891825|"~     Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause~     significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can~     be technically difficult. This study compares percutaneous ablation to thoracoscopic~     surgical AF ablation.~   "
89039|NCT01891812|"~     Patients who have sickle cell VOC are usually treated with opioids, such as morphine.~     However, this current way of treating them has not improved the health, medical outcomes, or~     rates of hospitalizations. In addition, since VOC can happen very frequently over a long~     period of time, giving opioids over and over again can cause both short-term and long-term~     problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better~     alternative to repeatedly giving opioids over long periods of time. N2O has been shown to~     provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not~     improve with morphine infusions, and is used extensively in France, where almost half of 85~     pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did~     not get better with standard treatment with morphine. However, pain relief which N2O~     provides in the acute setting has not been well described. Therefore, the purpose of our~     study is to describe how well N2O can relieve the pain in patients with SCD who present to~     the emergency department and are experiencing a VOC.~   "
89408|NCT01887015|"~     To evaluate whether early application of nasal high flow oxygen therapy after extubation can~     reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) after~     abdominal surgery in patients with intermediate to high risk of postoperative pulmonary~     complications.~   "
89040|NCT01891799|"~     The purpose of this study is to understand how best to provide care and treatment services~     to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland.~     The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission~     (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV)~     therapy regardless of their disease stage. The goal is to prevent delays in women accessing~     treatment for their own health and ensure that women and their children remain in care. This~     study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the~     current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health~     facilities in the Manzini and Lubombo regions in Swaziland. The study has three components:~     the main component is a PMTCT Options Evaluation where data from medical records will be~     abstracted on all HIV positive pregnant women attending antenatal services at the 10~     selected study facilities; data will be abstracted on their HIV exposed infants as well.~     Other components of the study include a PMTCT Options Acceptability Evaluation using~     semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as~     a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.~   "
89041|NCT01891786|"~     The primary objective of the CORDIA study is to use an effective evidence-based~     self-management intervention (SMI) for type 2 diabetes, with and without a novel test to~     give a personalised genetic and lifestyle risk of coronary heart disease, to examine their~     capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management~     in primary care patients with type 2 diabetes. The effect of these interventions on~     clinical, behavioural and psychological outcomes will be investigated.~   "
89042|NCT01891773|"~     Asthma is the most common chronic pediatric disease in the United States, and is the most~     common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged~     minority children receive disproportionately poor asthma care and incur a disproportionate~     share of asthma-related morbidity. The District of Columbia is particularly severely~     affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of~     22%, more than double the national average.~      One of the major challenges in treating asthma is poor adherence to daily controller~     medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH~     guidelines for asthma management. In an attempt to overcome poor compliance, investigators~     in Rochester, New York have partnered with primary care providers in their community to~     arrange for ICS administration at school by school nurses, and this approach yielded~     significant improvements in several asthma outcomes.~      The investigators propose to collaborate in a pilot research project with the overall goal~     of improving asthma outcomes through reducing barriers to medication adherence.~     Specifically, the investigators aim to improve adherence to controller medications (inhaled~     corticosteroids - ICS) among DC children with asthma through the following activities:~        1. A pilot prospective randomized clinical trial of home vs. school administration of ICS~          among DC children in grades kindergarten-8 with persistent asthma.~        2. Qualitative interviews with nurses from DC public and public charter school to identify~          key barriers to administration of daily controller medications in the school setting~   "
89043|NCT01891760|"~     -  Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional~          treatment of four-layer compression bandaging therapy alone, in subjects who completed~          the ABH-Dermagraft-001-08 study.~        -  Study Hypothesis: N/A (Long-term follow-up study)~   "
89044|NCT01891747|"~     This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in~     combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma.~     The primary objective of this phase II trial is to determine whether the addition of~     high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free~     survival (PFS) compared to previously reported results.~   "
89045|NCT01891734|"~     This project will be the first to evaluate the Moving Forward app in VA. Identifying an~     effective treatment for anxiety and depression in primary care is imperative within Veterans~     Health Administration as they are both common, chronic, and debilitating conditions~     associated with a number of personal and health-related costs. In close partnership with app~     developers at Mental Health Services, a major contribution of this research is the~     actionable feedback on the acceptability, feasibility and effectiveness of augmenting~     traditional Problem Solving Therapy with the Moving Forward app for future app development.~     If effectiveness can be established, Moving Forward has the potential for integration into~     the larger continuum of care for depression and anxiety in Primary Care-Mental Health~     Integration (e.g., care management, co-located collaborative care). Lastly, this pilot~     project will provide preliminary data for future research on SmartPhone technology. Veteran~     feedback on treatment components, ease of executing the study successfully and preliminary~     effect size calculations, will inform the design of the larger project.~   "
89046|NCT01891721|"~     Cognitive dysfunction is a major contributor to the poor community outcome of individuals~     with schizophrenia. Developing more effective cognitive remediation interventions is~     imperative to improve the daily lives of affected subjects and reduce the disability of this~     illness. The goal of this clinical trial is to evaluate two types of cognitive training~     approaches to determine which one is more beneficial for individuals with schizophrenia.~     This study also uses electrophysiological techniques to gain a better understanding of the~     mechanisms involved in cognitive remediation. Findings from this study will provide~     information about how to design the most optimally efficient cognitive training intervention~     to improve the cognitive and social functioning of patients with severe mental illness.~   "
89047|NCT01891708|"~     a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell~     lung cancer~   "
89092|NCT01891123|"~     As cytotoxic agents, DTX and PTX have a narrow therapeutic window. BSA dosing leads to great~     inter-individual PK variability, which is a major contributor for severe toxicity,~     especially in East-Asian populations. DTX exposures measured by area under plasma~     concentration-time curve (AUC), PTX exposures measured by the time above a plasma~     concentration of 0.05 µmol/L (TC>0.05), are the most biologic effects associated PK~     parameters for DTX and PTX, respectively, which could positively predict related toxicities~     such as neutropenia, peripheral neuropathy, etc. So, we conducted a randomized clinical~     trial to compare the effect on related toxicities and efficacy of PK-guided dosing strategy~     and BSA dosing strategy.~   "
89048|NCT01891695|"~     The dose of radiation most commonly used to treat oropharyngeal cancer results in side~     effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered~     taste, swallowing problems including pain or inability to swallow requiring feeding tubes to~     be placed in the stomach, hoarseness or breathing problems from swelling requiring~     tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe,~     nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear~     drums in the middle ear, skin redness tenderness and blistering.~      The purpose of this study is to determine if the investigators can reduce the dose of~     radiation to the lymph nodes in the neck that may contain cancer cells that are not detected~     by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in~     order to reduce the side effects from treatment and still adequately kill any cancer cells~     that may be contained in those lymph nodes.~   "
89049|NCT01891682|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,~     while synthesis of muscle and structural proteins is decreased. The metabolism of sulfur~     amino acids and specifically methionine and cysteine have not been investigated in~     critically ill septic children, despite that sulfur amino acids have important roles on~     thiol, antioxidant and epigenetic reactions, as well as precursor of glutathione (GSH).~     Methionine metabolism in critically ill children will be influenced by its rate of~     utilization through the transmethylation, remethylation and transsulfuration pathways, which~     are the major pathways of methionine metabolism.~      The investigators study aims to investigate the metabolism of methionine and cysteine in~     parenterally fed critically ill septic children. The investigators aim to determine the~     rates of transmethylation, remethylation, transsulfuration and GSH synthesis rates in~     critically ill septic children, to determine in vivo, whole body sulfur amino acid~     metabolism when sulfur amino acids are supplied by the parenteral route. The objective is to~     determine whether current parenteral intakes support GSH synthesis and if methionine~     metabolism differs when supplied by the parenteral versus the enteral route. Methionine~     parenteral requirements will be also studied by using the indicator amino acid oxidation and~     balance technique.~   "
89050|NCT01891669|"~     To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
89051|NCT01891656|"~     Substance abuse treatment in the criminal justice system can reduce drug use and related~     criminal behavior. Although drug and alcohol treatment are common mandates in criminal~     justice programs, only a minority of clients actually initiate treatment. This proposal will~     compare two intervention formats that target motivation to initiate and engage in treatment~     among a group of probationers who have drug or alcohol treatment conditions. Six hundred~     drug and alcohol offenders in two probation sites (Baltimore, MD and Dallas, TX) will be~     randomized to receive: 1) an in-person motivational interviewing session (MI), 2) a~     motivational computer program (MC), or 3) supervision intake and monitoring as usual (SAU).~     The MI condition will be structured along the lines of the Check-Up format which consists~     of an assessment and personalized feedback delivered in an MI style; the content of the MC~     condition will be drawn from previous literature on effective motivational computer~     programs. Both interventions will be delivered at the start of the probation process, with~     follow-up assessments at 2 and 6 months. Primary outcomes include engagement and~     participation in substance abuse treatment; secondary outcomes include drug and alcohol use,~     probation progress, criminal behavior, and HIV testing and care. This project will be the~     first to develop and test two interventions for encouraging criminal justice clients to~     follow through with treatment recommendations, with the goal of increasing treatment~     initiation, and reducing subsequent drug use and criminal behavior. It also contributes to~     ongoing partnerships with two large probation agencies—the Dallas County Supervision and~     Corrections Department and the Maryland Division of Parole and Probation.~   "
89052|NCT01891643|"~     The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and~     Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma~     cells at the time of progression than those who receive Lenalidomide and Dexamethasone~     without Elotuzumab~   "
89053|NCT01891630|"~     To determine if baseline asthma control influences susceptibility to pollutant-induced~     health effects in African-American children with moderate-to-severe asthma.~   "
89054|NCT01891617|"~     Determine whether the mid-day suppression of hunger and amplified increase in the release of~     glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following~     morning exercise is due to increased fat content of the diet per se or a combination of high~     fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric~     emptying is likely to be important in mediating its effects on postprandial appetite and~     glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide~     secretion when diet is enriched with fat, and that this stimulus suppresses the hunger~     sensation.~   "
89055|NCT01891604|"~     Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm~     infants' health, and may also play a role in reducing NEC and associated morbidity.~   "
89056|NCT01891591|"~     This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and~     nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try~     quantitate energy and protein balance after RYGP, and to identify how RYGP effects the~     intake of various common dietary protein sources 16 female patients with BMI > 40 kg/m2 and~     on a waiting list for bariatric surgery will be included. The following measurements will be~     performed before, and 1, 3, 6, 12, and 36 months after RYGP~        -  body weight~        -  body composition (bio impedancemetry)~        -  basal metabolic rate (open circuit indirect calorimetry)~        -  24-hour urinary urea excretion~        -  fasting blood chemistry~        -  energy and macronutrient's intake (3-day dietary recall)~   "
89057|NCT01891578|"~     Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative~     preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis~     lymphoma~   "
89409|NCT01887002|"~     The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by~     rectal distention in female patients with IBS-D~   "
89058|NCT01891565|"~     The amount of active therapy provided to patients on an inpatient stroke rehabilitation unit~     has been reported as often insufficient. Observational studies have found that in the first~     14 days post stroke, patients receive very little therapy and have very low activity levels.~     More opportunity to practice may, however, improve short-term outcomes such as the level of~     mobility, endurance, use of the affected arm and leg, and length of stay. The Stroke~     Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT) trial will utilize sensors that~     reveal the type, quantity, and aspects of quality of patient activities outside of the~     confines of research laboratories. SIRRACT will deploy inexpensive Personal Activity~     Monitors (PAMs), comprised of triaxial accelerometers worn on the thighs.~      The objectives of the study are:~      i. To assess the impact of feedback from Personal Activity Monitors (PAM)s on amount of~     active practice, walking speed and distance in stroke patients undergoing rehabilitation.~      ii. To assess the impact of feedback from PAMs on physical, psycho-emotional, cognitive and~     ecosocial Health-Related Quality of Life of stroke patients undergoing rehabilitation.~      iii. To assess the acceptability of thigh-strapped accelerometer use among stroke patients~     undergoing rehabilitation.~      iv. To assess the reliability and validity of thigh-strapped accelerometer use among stroke~     patients undergoing rehabilitation.~      Hypotheses In moderate to severely disabled subjects who are receiving in-patient~     rehabilitation, daily feedback from PAMs about purposeful activity will increase the amount~     of active practice by >30%, a higher proportion of subjects who reach the level of~     independence for walking, and increase walking speed by 25%, leading to higher mean walking~     speeds and distances at the time of discharge from inpatient rehabilitation. Daily feedback~     from PAMs on increase in walking speed and distances will improve physical, psychological,~     cognitive and ecosocial domains of Health-related quality of life.~   "
89059|NCT01891552|"~     -  The recently introduced chemoembolization has been considered to be a very attractive~          new method in terms of response in the treatment of liver metastases from colon cancer~          carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new~          embolization materials.~        -  An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in~          patients with liver metastases from colon cancer, who had been pretreated with 2 or~          more lines of chemotherapy.~        -  Since a greater activity was attained by a combination of Cetuximab and Irinotecan~          versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal~          Products (EMEA) has granted authorization to the use of Cetuximab in association with~          irinotecan in the treatment of irinotecan-refractory CRC-LM.~        -  In this study we want to collect data on on time to progression and tolerability using~          DEBIRI+Cetuximab in LM-CRC~   "
89060|NCT01891539|"~     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the~     seventh in women and is the third most common cause of death from cancer worldwide. The~     overall incidence of HCC remains high in developing countries and is steadily rising in most~     industrialized countries.~      TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel~     therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded~     beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong~     its permanence within the tumor. The comparison of efficacy and safety of TACE with~     drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response~     and time to progression in the group was significantly higher than that of the cTACE group.~     TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to~     the treatment of HCC.~      This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE~     using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular~     carcinoma.~   "
89061|NCT01891526|"~     To test whether patients with hepatic insufficiency can tolerate one oral dose of~     9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.~   "
89062|NCT01891513|"~     The purpose of this study is to compare, when combined with chronic exercise, the effects of~     perindopril, losartan, and hydrochlorothiazide.~   "
89063|NCT01891500|"~     The investigators in this study are concerned about the harmful effects of oxygen exposure~     in newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an~     FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and~     late-preterm babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when~     a patient's lungs cannot get enough oxygen into their bloodstream. This condition is~     traditionally treated with high concentrations of oxygen and most often requires the patient~     be placed on a ventilator (breathing machine). The administration of inhaled nitric oxygen~     directly into the lungs often improves blood oxygen levels and allows caretakers to reduce~     the amount of oxygen given to the baby. The purpose of this research study is to evaluate if~     giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness~     of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the~     total amount of time a patient requires supplemental oxygen. This study uses an FDA approved~     drug in a new manner.~   "
89064|NCT01891487|"~     This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus~     placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week~     study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects~     eyebrow for duration of the study.~   "
89065|NCT01891474|"~     Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed~     and improved glycemic control. However, previous U-healthcare service had some limitations,~     which needs specific devices to check blood glucose and send it to central system. Voice~     inception technique based U-healthcare service is expected to improve glycemic control~     without specific devices.~      To evaluate the clinical efficacy of this system, researchers plan to compare the~     improvement of glycemic control, self-management, and quality of life between U-health care~     group (intervention) and conventional treatment group (control).~   "
89066|NCT01891461|"~     The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease~     intraoperative and immediate post-operative bleeding.~   "
89105|NCT01890954|"~     The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in~     adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's~     ability to significantly improve blood glucose levels when an insulin bolus is omitted for a~     30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of~     carbohydrates consumed for a meal. The primary objective of this study is to use a~     closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood~     glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin~     for either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.~   "
89106|NCT01890941|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
89154|NCT01890317|"~     Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate~     whether induction of mild hypothermia in addition to primary percutaneous coronary~     intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic~     shock improves cardiac power index after 24 h.~   "
89067|NCT01891448|"~     The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the~     reporting of randomized trials. If trials are not well reported it is difficult for~     clinicians to use best evidence to inform clinical practice and patients may not get the~     best care. A number of different CONSORT extensions have been developed which specify~     additional information needed for more complex trials. The aim of this project is to~     evaluate whether using a simple web-based tool (WEBCONSORT) improves the reporting of~     clinical trials. The tool combines different CONSORT extensions and allows authors to obtain~     a checklist and flow diagram which is specific to their individual trial. In this study~     authors of participating journals are requested, at the manuscript revision stage, to use a~     web-based tool to improve the reporting of their randomized trial. Authors registering to~     use the tool are randomized to intervention or control. In the intervention group authors~     are directed to the WebCONSORT tool. In the control group, authors are directed to a~     different version of the WebCONSORT tool which includes the flow diagram part of the tool~     but not the main checklist or elements relating to CONSORT extensions. The aim is that this~     tool should lead to improvements in the reporting of randomized trials, making it easier for~     clinicians to read and interpret published findings.~   "
89068|NCT01891435|"~     A randomized clinical trial to check the antipyretic efficacy of oral and intravenous~     paracetamol and intramuscular diclofenac sodium in patients presenting with fever to~     emergency department.~   "
89069|NCT01891422|"~     The glycoproteinoses are among the most rare and least researched of the lysosomal diseases.~     The diseases include aspartylglucosaminuria, fucosidosis, galactosialidosis,~     alpha-mannosidosis, beta-mannosidosis, mucolipidosis II, mucolipidosis III, Schindler~     disease, and sialidosis. Longitudinal studies of these conditions are needed in order to~     better define how common the diseases are, identify clinical features which could contribute~     to early diagnoses, detail progression of the diseases, assess the supportive therapies~     currently used, and identify potential treatments. Laboratory tests will evaluate metabolic~     and genetic defects found in participants' blood and urine samples.~   "
89070|NCT01891409|"~     A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male~     circumcision device across all childhood age groups namely infants (under 1), 1-5 age group,~     6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and~     course of wound healing when using the Shang Ring technique across the four childhood age~     groups.~   "
89071|NCT01891396|"~     The purpose of this study is to see if a single injection of Cingal into the knee provides~     safe relief of pain caused by osteoarthritis.~   "
89072|NCT01891383|"~     The objective of this study is to measure the frequency and clinical types of mild cognitive~     impairment (MCI) or dementia that occur among up to 150 military retirees with and without a~     history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home,~     Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare~     the characteristics of dementia in those who have had a prior TBI to the characteristics in~     those without a history of TBI. It is our hypothesis that the dementia or MCI among those~     with prior TBI has distinct neuropsychological features that distinguishes it from those~     with dementia or MCI without a history of TBI.~   "
89073|NCT01891370|"~     The purpose of this study is to get initial values (normal medians) for certain biochemical~     serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood~     pressure measurement and certain ultrasound measurement may be established.~   "
89074|NCT01891357|"~     The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response~     evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast~     cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with~     lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12~     weeks.~   "
89075|NCT01891344|"~     The purpose of this study is to determine which patients with ovarian, fallopian tube, and~     primary peritoneal cancer will best respond to treatment with rucaparib.~   "
89076|NCT01891331|"~     CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the~     accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs~     referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is~     responsible for many of the side effects associated with these drugs. VT-1161 has been~     design to be safer and more active against the fungal species typically responsible for~     vaginal yeast infections (i.e. vulvovaginal candidiasis)~   "
89077|NCT01891318|"~     This Phase I/II trial studies the ability to stop brain metastases from coming back after~     treatment with radiosurgery followed by surgical resection. It will also evaluate the side~     effects of these combined treatments and help determine the best radiosurgery dose.~     Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal~     tissue in the brain.~   "
89078|NCT01891305|"~     The purpose of this study is to determine if the novel oral agent VT-1161 is safe and~     effective in treating patients with moderate - severe tinea pedis (also referred to as~     athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal~     growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the~     fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole~     antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this~     results in many of the side effects associated with the azole antifungals. The safety~     profile of the class similarly limits use in chronic treatment of non-life-threatening~     fungal infections. A safer antifungal drug would improve treatment options for infections~     seen in otherwise healthy individuals where significant side-effect risks are unacceptable.~   "
89079|NCT01891292|"~     The purpose of this study is to determine whether enalapril or antioxidant therapy~     (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell~     disease and and its progression to sickle nephropathy~   "
89080|NCT01891279|"~     In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis~     or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula~     allowed the infant to wean off Total Parenteral Nutrition (TPN) earlier?~   "
89476|NCT01886131|"~     To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field~     potentials recordings, during the phasic behaviours of RBD with the electrical activity~     recorded at this level during the execution of voluntary movements during the off and the~     on phases in patients with RBD secondary to PD.~   "
89081|NCT01891266|"~     Background:~      Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems~     in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may~     be the only option that offers the possibility of reestablishing the patient's life quality.~      Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet~     around the thigh. The method aims to reduce blood loss and give the surgeon better~     visibility during the operation. The method is, however, not without side effects as~     patients often experience severe pain and swollen leg in the time after surgery.~     Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged~     rehabilitation and reduced physical function.~      It is, however, possible to perform the operation without the use of the tourniquet.~      Aim and hypothesis:~      The aim of the present study is to assess the effects of tourniquet use in TKA on physical~     function, early rehabilitation, pain and opioid consumption.~      Hypotheses H1: TKA without tourniquet leads to better physical function and early~     rehabilitation.~      H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of~     mechanical lower limb function post TKA is faster without use of tourniquet.~      Methods:~      80 patients (40 in each group) all eligible for TKA will be consecutively recruited and~     randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated~     before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.~      The primary outcome will be the change from baseline to 3 months in self-administered~     knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified~     secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with~     sports and leisure activities, and quality of life. In addition, muscle function, physical~     performance, and the use of pain medication will be studied~      Impact of the project:~      The project design of this study will enable analyses for determining the impact of~     operating without tourniquet and whether such an intervention can in fact improve physical~     function, performance and quality of life within TKA patients. The results may impact~     notably on the patient level and possible redefine current surgical strategies. The societal~     perspective of the project is to remobilize patients faster, which may reduce hospital~     services and absence from work.~   "
89082|NCT01891253|"~     Measuring hemodynamic parameters in ventilated patients is important yet still complicated~     to perform. Inert gas rebreathing (IGR) showed promising results when being compared to~     other invasive as well as non-invasive techniques for the measurement of cardiac output. The~     aim of our study is to evaluate the feasibility of IGR in ventilated patients.~   "
89083|NCT01891240|"~     The overall objective of the IMPROvED project is to develop a sensitive, specific,~     high-throughput and economically viable early pregnancy screening test for preeclampsia.~      This will involve a multicentre, phase IIa clinical predictive study to assess and refine~     novel and innovative prototype tests based on emerging metabolomic and proteomic~     technologies developed by SMEs (small to medium size enterprise) within the consortium. The~     study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank,~     augmented by accurate clinical metadata; iii) determine whether prototype predictive assays~     and algorithms translate to the clinical environment; iv) assess potential synergy of a~     combined metabolomic and proteomic approach and v) progress regulatory approval and~     development of the selected test into the clinical arena.~   "
89084|NCT01891227|"~     Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy~     with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine~     alone until disease progression or unacceptable toxic effects. Safety assessments will be~     conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9~     weeks.~      Aim of this study is to determine whether treatment with capecitabine in combination with~     bendamustine is efficacious and safe.~   "
89085|NCT01891214|"~     The purpose of the study is to develop a validated French version of the IBDQ in a cohort of~     patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative~     Colitis.~   "
89086|NCT01891201|"~     The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has~     any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary~     objective is to assess the effects on exclusive breastfeeding at 3 months~   "
89087|NCT01891188|"~     Clinical studies are required to validate the hepatic NIRS monitor with other regional and~     global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive~     hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional~     oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If~     found to correlate then the NIRS can be used to evaluate early liver transplant failure~     and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing~     enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic~     liver pathologies. If our validation study finds that NIRS monitors are an appropriate~     marker of hepatic venous saturation then it will lead to further clinical studies.~   "
89088|NCT01891175|"~     The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an~     absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia~     intradural in the pregnant women, fact that worries for provoking undesirable effects so~     much in the mother and as in the fetus /newborn baby.~      The purpose of this study is to determine the effectiveness of intermittent pneumatic~     compression system in the lower extremities in order to reduce the vasopressors drugs~     requirements to maintain hemodynamic stability in pregnant women undergoing elective~     caesarean sections with an spinal anaesthesia.~   "
89089|NCT01891162|"~     Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk~     factors for female urinary incontinence and pelvic organ prolapse at the population level.~     The socioeconomic risks for incontinence have however, conflicting evidence with assorted~     measures of socioeconomic status. Brazil is a country with enormous social contrasts, and~     deep inequality. We have a mixed origin of cultures and different economic and regional~     conditions. We believe that the perception and the impact that has Pelvic floor dysfunction~     in the quality of life of the woman must vary widely according to socioeconomic status~     (including household income, highest educational level, family income). There is to date no~     studies have correlated a criterion for classifying economic official in Brazil with the~     impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and~     pelvic organ prolapse.~   "
89090|NCT01891149|"~     This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic~     and hormonal characteristics of women and without obstetric fistula.~      Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is~     at least 10 mm shorter than the mean cervical length measurement of similar women without~     obstetric fistula.~      Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with~     obstetric fistula will allow us to assess the cause of amenorrhea in these women.~   "
89091|NCT01891136|"~     This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or~     tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.~   "
89093|NCT01891110|"~     Background:~      The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution~     during verticalisation in persons with spinal cord injury (SCI) is a common condition.~      Aims:~      To investigate the impact of three different types of electric stimulation (ES) (ES of the~     abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and~     lower limb muscles versus control) on blood pressure stabilization and~     verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced~     contractions of the muscles cause a stabilisation respectively an increase of the blood~     pressure during the tilt-table test.~      Subjects:~      20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a~     lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C~     and a diagnosis of OH (by tilt table test) were eligible for the study.~      Methods:~      Each patient underwent randomly three different types of ES sessions while being positioned~     on a tilt-table. The following sessions were planned:~      A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D)~     Control session (=diagnostic session)~      Study type: Intervention Design: Prospective interventional study~   "
89094|NCT01891097|"~     This is a randomized controlled trial to evaluate the clinical efficacy of combined~     electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult~     population in Hong Kong.~   "
89095|NCT01891084|"~     The purpose of this study is to investigate the potential benefits and risks of antipyretics~     use in naturally occurring influenza virus infections in humans.~   "
89096|NCT01891071|"~     Multiple sclerosis is a neurological disease that can affect lung function and cough~     efficacy. This pilot study will examine whether the lung volume recruitment technique can~     slow down the decline in lung function and cough.~   "
89097|NCT01891058|"~     Atrial fibrillation (AF) and atrial flutter (AFL) are cardiac rhythm problems where there is~     an irregular, rapid heart rate. Investigators plan to study Emergency Department (ED)~     patients with recent-onset episodes of AF or AFL (RAFF) where rapid heart rate requires~     urgent treatment to restore normal heart rhythm. RAFF is the most common rhythm disorder~     managed in the ED. Investigators recently showed that doctors use a wide variety of~     treatment approaches in Canadian EDs for RAFF. Also, the Canadian Cardiovascular Society~     Guidelines indicate that there have not been enough studies to know if the best treatment is~     to use an electrical shock (Shock Only) or drugs followed by shock (Drug-Shock).~     Investigators believe that Drug-Shock approach will be more effective and will help avoid an~     electric shock for many patients. Investigators also do not know if electrical shocks should~     be given with the electrode pads on the front (antero-lateral) or front and back~     (antero-posterior).~      Investigators intend to conduct 2 randomized protocols within one study (partial factorial~     design) in order to answer these two questions. 1. Will initial drug treatment followed by~     electrical shock if necessary (Drug-Shock) lead to more patients being converted to normal~     heart rhythm than a strategy of only electrical shock (Shock Only)? 2. Will the~     antero-posterior pad position be more effective than the antero-lateral position?~     Investigators plan to enroll 468 RAFF patients at 8 large Canadian EDs. Patients will be~     randomized to 1 of 2 arms for each of the two protocols. Investigators primary outcome will~     be conversion to normal heart rhythm. Other outcomes will include heart rhythm at discharge,~     need for hospital admission, length of stay in ED, adverse events, patient satisfaction, and~     14-day follow-up status.~      Investigator results will add important information about the best and safest ways to treat~     RAFF patients in Canadian EDs. Ultimately Investigators expect to see fewer patients~     admitted to hospital and more patients rapidly and safely returned to their normal~     activities.~   "
89098|NCT01891045|"~     Dropout represents one of the largest problems in substance abuse treatment. International~     and Nordic research show that only 20 - 40 % of substance abusers complete treatment as~     intended. At the same time, one of the most consistent factors of favourable post-treatment~     outcome is treatment completion. In spite of the serious and continuous challenge dropout~     represents the phenomena is not well understood and there is a need to explore more of the~     factors that influence dropout and how it can be counteracted. As also stated: …effective~     methods for reducing the problem of dropouts from treatment is one more area in need of~     further research (NOU 2003:4, s 77).~      For the general field of mental health one of the most important innovations involves~     providing therapists with patient feedback about their progress. The most well-established~     and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has~     been shown to improve treatment outcomes, including reduced treatment dropout and length of~     treatment, but the system is yet to be utilized with a substance abusing patient group. The~     aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing~     patients.~   "
89099|NCT01891032|"~     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be~     related with the degree of acute kidney injury. We are trying to analyze whether it is~     related with the grade of acute kiney injury after partial nephrectomy and there is any~     difference between the kinds of surgery.~   "
89100|NCT01891019|"~     The objective of this study is to obtain information on the effectiveness of thalidomide in~     psoriasis.~   "
89101|NCT01891006|"~     The purpose of this study is to examine whether Negative Pressure Wound Therapy is an~     effective wound treatment compared to conventional wound treatment in the period of time~     from reoperation to re-suturing in women having surgical wound rupture after Caesarean~     Section.~   "
89102|NCT01890993|"~     This study is conducted in Europe. The aim of this study is to demonstrate the clinical~     effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy~     in routine primary care in Europe.~   "
89103|NCT01890980|"~     The goal of this clinical research study is to learn if the Wilms Tumor-1 (WT1) vaccine,~     when given in combination with montanide and GM-CSF, can help to prevent or delay~     mesothelioma from coming back after surgery and treatment. The safety of this vaccine will~     also be tested.~      Montanide and GM-CSF are designed to cause white blood cells to grow, which may help to~     increase the immune response.~      WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.~     Mesothelioma tumors usually have high levels of WT1. The WT1 vaccine is designed to cause~     the increased immune response created by other drug combinations (like montanide and GM-CSF)~     to be directed at mesothelioma.~   "
89104|NCT01890967|"~     This study is designed to define the amount and duration of cholesterol lowering and to~     assess the safety and tolerability of different dose regimens of LY3015014 in participants~     with high cholesterol. The study will also investigate how the body processes the drug and~     how the drug affects the body. Participants will remain on a stable diet and will continue~     taking cholesterol-lowering medications (statins with or without ezetimibe). After signing~     the informed consent document, the participant will complete a screening/run-in period that~     will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks.~     After the treatment period, the participants will complete a follow-up period lasting~     approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.~   "
89107|NCT01890928|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Often sick children have increased glucose concentrations in blood. However, the~     origin of the high glucose has not been determined in these populations. There is a close~     interrelationship between protein and energy metabolism. An increase in the energy supply~     will not promote nitrogen retention unless the amino acid supply is adequate, and~     conversely, an increased amino acid supply will be useless if energy is limiting, hence the~     importance of adequate protein and energy intake. Our study aims to investigate the~     protein-energy interactions in critically ill septic children and adolescents with the~     objective to eventually provide the best nutritional support for these patients.~   "
89108|NCT01890915|"~     The deleterious effects of hyperthermia are well appreciated in able-bodied persons.~     However, the consequences of impaired regulation of normal body temperature on cognitive~     performance of persons with tetraplegia is not known. This study will provide the~     preliminary findings necessary for future work to design and explore physical and medical~     interventions to improve temperature regulation in those with tetraplegia with the goal of~     improved clinical care, health, and quality of life.~      The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10~     controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours.~     Physiological as well as psychological processes will be monitored in all subjects during~     the study for safety and to determine differences in responses to exposure to hot ambient~     temperatures~   "
89109|NCT01890902|"~     The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen~     10% Cream) compared to placebo for acute pain associated with OA flare of the knee.~   "
89110|NCT01890889|"~     The purpose of this study is to evaluate the effectiveness of a food-source nutrient~     containing bitter orange by comparing changes 45 blood chemistries and self-reported quality~     of life.~   "
89111|NCT01890876|"~     Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which~     may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500~     - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose~     metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance~     considering the increasing number of persons suffering from impaired glucose tolerance or~     diabetes and the unique opportunities provided by the mountainous regions of the Alps to~     perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude~     between 1500 - 3500 m. Metabolic responses to exercise may be largely mediated by~     interleukin 6 (IL-6), which is predominantly derived from the contracting limbs and may~     support the maintenance of metabolic homeostasis during exercise. In addition, IL-6 is~     elevated with acute and chronic altitude exposure at least partly mediated via adrenergic~     stimulation. Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations~     and differences in serum IL-6 concentrations might help to explain distinctions between~     responses of glucose metabolism to CE and EE at low and moderate to high altitude.~      32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or~     uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9~     sessions at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic~     condition will be a break of approximately 12 month. Measurements of glucose metabolism,~     IL-6 plasma concentration will be performed pre, mid (day 5) and post intervention. Moreover~     anthropometric, strength and exercise capacity characteristics will be performed pre and~     post intervention.~      We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in~     pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that~     effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE~     in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than~     CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in~     normoxia.~   "
89112|NCT01890863|"~     This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol~     combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi)~     relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to~     establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area~     under time concentration curve [AUC] and Salmeterol maximum concentration [Cmax]) no greater~     than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study~     will enroll 36 healthy adult male and female subjects and each subject will be allocated to~     one of two sequences and will participate in four treatment periods, receiving each of the~     treatments twice.~   "
89113|NCT01890850|"~     This study aims to estimate the risk factors associated with pertussis/whopping cough~     infection among infants less than one year of age in a United States (U.S.) commercially~     insured population. The study will utilize a large research data base associated with a~     geographically diverse U.S. health plan not limited by one geographic area or disease~     outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and~     utilization among infants with a reported diagnosis of pertussis/whooping cough stratified~     by the number of DTaP vaccinations received prior to infection will also be reported.~   "
89114|NCT01890837|"~     The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three~     times per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal~     nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and~     sensation threshold for pain) in response to rectal balloon distension by barostat in~     patients with IBS.~   "
89115|NCT01890824|"~     Following chemotherapy, breast cancer patients primarily gain fat mass and lose muscle mass.~     Both depletion of muscle and an increase of fat mass in breast cancer patients are related~     to short survival, and decreased skeletal muscle mass and function may result in fatigue and~     inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity~     and increased mortality. The purpose of this study is to provide detailed insight in~     chemotherapy related changes in lipid metabolism and gut digestion and absorption of fat in~     breast cancer patients compared to matched healthy controls. This will provide required~     information that is necessary to implement new strategies to develop optimal nutritional~     regimen in breast cancer patients. The hypothesis is that chemotherapy in breast cancer is~     related to altered gut function and absorption and to increases in fat synthesis that lead~     to fat accumulation. In addition, we will examine the effect of cancer, chemotherapy, and~     gender by comparing fat digestion/absorption and fat metabolism of the breast cancer before~     and after chemotherapy, to aged matched healthy female and male controls.~   "
89126|NCT01890681|"~     This study will evaluate the efficacy of a six-month-long intervention in improving the~     nutrition and physical activity environments of child care centers serving racially and~     ethnically diverse children from birth to two years of age and the family home. The focus of~     the intervention will be on center policies, provider and parent practices, and children's~     home environments that influence dietary intake and physical activity. Outcomes for this~     study include child dietary intake, physical activity, and two adiposity measures:~     weight-for-length and skinfold thicknesses. Child care centers and children's home~     environments will also be measured to evaluate how well they support healthy behaviors.~   "
89116|NCT01890811|"~     Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively~     influencing their quality of life, treatment response and survival. Loss of muscle protein~     is generally a central component of weight loss in CKD patients but patients also have~     reductions in fat mass and bone density, independent of the severity of the disease state.~     Attempts to reverse weight and muscle loss in CKD and improve nutritional status by~     nutritional supplementation have been unsuccessful and there are currently no approved~     therapies.~      Purpose of this study is to provide detailed insight in disease related gut function by~     obtaining information on gut permeability, digestion and absorption of glucose, fat and~     protein in CKD patients compared to matched healthy controls. Additionally, to examine~     whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy~     controls. This will provide required information that will lead to implement new strategies~     to develop optimal nutritional regimen in order to enhance nutritional status, quality of~     life and survival in relation to kidney disease.~   "
89117|NCT01890798|"~     This is a single arm, open-label continued access protocol of drisapersen for the treatment~     of male subjects with Duchenne muscular dystrophy (DMD) having dystrophin mutations~     correctable by drisapersen-induced DMD Exon 51 skipping. The purpose of this continued~     access protocol is to offer pre-approval access to drisapersen for the treatment of subjects~     with DMD who previously participated in eligible drisapersen studies. The protocol will~     collect safety data required to assure subject safety and periodic efficacy data on muscle~     function.~   "
89118|NCT01890785|"~     Compare the pharmacokinetic profiles when the contents are emptied into a soft food and~     orange juice compared to the SPD489 when swallowed as an intact capsule.~   "
89119|NCT01890772|"~     This study is for people who have been diagnosed with chronic hepatitis C, specifically~     those who have a certain type of the virus, genotype 1, and who have not yet received~     treatment for hepatitis C. This pilot study is designed to test whether the addition of~     vitamin D, to the three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and~     ribavirin) that are approved by the Food and Drug Administration (FDA) for the treatment of~     hepatitis C, can help eliminate the HCV from the body. Currently, doctors are unsure if the~     addition of vitamin D to prescribed hepatitis C therapy will have any effects on how the~     body clears the virus.~      Once enrolled, participants will be randomly assigned (like flipping a coin) to receive~     telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir~     + peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all~     races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 -~     20 participants/site).~      Participants assigned to the treatment group will begin a lead-in phase where they will~     receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase,~     participants will be tested to determine the Vitamin D level in their blood, as well as~     other tests, including HCV RNA (to determine the amount of virus present) and calcium~     levels. Once an adequate level of Vitamin D is detected in participants' blood, participants~     will begin treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3~     (15,000 IU/week) for 12 weeks.~      Participants randomized to the control group will immediately begin treatment with~     telaprevir + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the~     participants' involvement in the study will be complete.~      Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical~     history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at~     Screening, Day 1, Week 2, 4, 8 and 12.~   "
89120|NCT01890759|"~     The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine~     given as a two-dose series in infants and toddlers.~      Primary Objectives:~        -  To assess the seroprotection rate (percentage of subjects with a serum bactericidal~          assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses~          of Menactra® administered 3 to 6 months apart.~      Secondary Objectives:~        -  To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and~          W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR~          titers.~        -  To assess the safety profile of Menactra® after each and any vaccination.~   "
89121|NCT01890746|"~     The purpose of this randomized, blinded, placebo-controlled study is to provide clinical~     safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute~     Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus~     cytarabine. These safety data are considered necessary to further development of Eltrombopag~     in both adult and paediatric patients suffering from malignant diseases with secondary~     thrombocytopenia. A minimum of 120 evaluable subjects with newly diagnosed with AML will be~     stratified by antecedent malignant hematologic disorder and age.~   "
89122|NCT01890733|"~     This is a post-marketing study to further assess the safety and effectiveness of the~     InSpace™ device implantation in comparison to surgical repair of full thickness Massive~     Rotator Cuff Tear .~      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick~     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily~     living(ADL) and improvement of range of motion (ROM).~   "
89123|NCT01890720|"~     The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by~     caesarean section have a reduced incidence of wound infection and dehiscence when incisional~     Negative Pressure Wound Therapy is applied prophylactically following caesarean section.~   "
89124|NCT01890707|"~     The use of deep sedation may improve the quality of recovery of patients undergoing minor~     gynecologic procedures. These patients may also have shorter hospital stays and potentially~     lower healthcare costs. Additionally, the use of deep sedation for second trimester~     pregnancy termination may be associated with less bleeding, a smaller decrease in~     perioperative hemoglobin and better quality of recovery.~   "
89125|NCT01890694|"~     Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals~     with cirrhosis may develop low blood sodium as a complication of their liver disease. In~     these patients, the presence of low blood sodium may exacerbate other complications such as~     encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability~     of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for~     the treatment of their low blood sodium.~      The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients~     with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials~     that led to its approval did not otherwise assess clinical benefit of the drug.~      This study is designed to determine whether patients with cirrhosis derive a clinical~     benefit when they receive tolvaptan for the treatment of hyponatremia within 2 days of~     admission. Specifically, whether it is associated with shortened length of stay and~     improvement in other complications of cirrhosis.~   "
89139|NCT01890512|"~     The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed~     at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™~     MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ~     endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under~     the labeled Conditions of Use.~   "
89127|NCT01890668|"~     Breastfeeding is one of the prime factors of long-term health protection in newborns, for~     nutritional, immunological and developmental reasons. In France there is a wide~     inter-regional variability of breastfeeding rates at discharge. This variability associates~     different factors involving both, mothers, birth conditions, newborns and mother-child~     couple. Some approaches, including osteopathy, aim to support early breastfeeding~     difficulties. As many others non-conventional medicines, there is a huge and growing~     interest for this alternative therapy and a spontaneous recourse in the first months of~     life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective~     is to evaluate for the first time in France, in a randomized, double-blinded design, the~     efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding~     behaviour healthy newborns.~      128 couples mother-child will be randomized in two groups: with or without osteopathic~     intervention on the newborn.~   "
89128|NCT01890655|"~     To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing~     remitting multiple sclerosis (RRMS).~   "
89129|NCT01890642|"~     This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws~     in children ages 6 and younger. The investigators will use video observation of patients to~     asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain~     Ease spray 3) Pain Ease spray plus the J tip noise.~   "
89130|NCT01890629|"~     To compare efficacy and safety of initial combination therapy of Gemigliptin versus~     Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in~     Patients With Type 2 Diabetes Mellitus.~   "
89131|NCT01890616|"~     In this research study the investigators want to learn more about gut transit times in~     Duchenne Muscular Dystrophy (DMD) patients over 18.~      The investigators hypothesized:~        1. DMD patients will exhibit prolonged gut transit times when compared to the general~          population;~        2. Abnormal transit times will correlate with increased age and worsening functional~          status.~   "
89132|NCT01890603|"~     Cluster randomized controlled trial comparing care coordination incentives to pay for~     performance (quality measure) incentives in clinics on utilization, cost, quality, and~     patient experience.~   "
89133|NCT01890590|"~     CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately~     to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to~     the target tumor allows a high dose to be delivered to the tumor, thus potentially~     increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for~     brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The~     purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of~     clinically localized primary renal cell carcinoma.~   "
89134|NCT01890577|"~     An observational study to describe the treatment of anaemia in patients with chronic kidney~     disease, who are receiving dialysis treatment at selected study centres in South Africa.~   "
89135|NCT01890564|"~     During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical~     visualization. Although effective in facilitating the procedure, there are respiratory~     consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure~     (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and~     increase closing capacity resulting in increased resistance, decreased compliance, and~     increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study~     will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric~     surgery to determine which is better able to support oxygenation and ventilation while~     limiting the peak inflating pressure (PIP).~   "
89136|NCT01890551|"~     Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and~     anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the~     patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected~     knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected~     knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with~     unilateral patellofemoral instability. For the control group invvestigators enrolled ten~     healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study~     parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle~     (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of~     flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and~     the HKG subjects (n=19). Results: In a comparison between the AKG patients and the HKG~     subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test. In~     these parameters the difference between the AKG patients and the HKG subjects progressively~     increased towards the full extension of the knee. In the AKG and UAKG patients BSO-ratio at~     0 degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG~     subjects ranged between 0.33 and 0.75 (P < .001). At the zero degree the LPD-test ranged~     between 0 and 10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients,~     whereas the lateral displacement-test ranged between 0 and 5 mm in the HKG subjects (P =~     .003). Patellar tilt angle-test ranged between -30 and 20 degrees in the AKG patients and~     between -30 and 24 degrees in the UAKG patients and in the HKG subjects the PTA-test ranged~     between 10 and 24 degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for~     the evaluation of patellar tracking in adolescents.~   "
89137|NCT01890538|"~     This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate~     and piracetam) in the symptomatic management of peripheral vertigo.~      The patients will be randomized in two groups according to symptomatic treatment modalities:~     Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30~     minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according~     to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be~     rate the intensity of symptoms in the following times:~        -  Numeric rating scale (1 to 10): Admission~        -  Numeric rating scale (1 to 10): After the study drug (No ambulation)*~        -  Numeric rating scale (1 to 10): After the study drug (Ambulation)*~             -  Ambulation refers to head movements or walking in the room, if applicable.~   "
89138|NCT01890525|"~     The purpose of this study is to compare different methods of collecting the amount of~     radiation exposure patients receive in a clinical study. As part of the PROMISE study, the~     Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients~     every six months to ask if they had any heart procedures or testing. This information will~     be used to estimate the amount of radiation that they may have received from heart testing~     being studied in this study, PROMISE-SAFER. Patients will be asked to collect information~     about each heart testing they receive during the time that they are enrolled in the PROMISE~     study. At the conclusion of the study, we will be able to determine which method was most~     accurate in collecting the amount of radiation exposure for this clinical study. Through~     this study we hope to develop an improved methodology to estimate cumulative radiation~     exposure from cardiac imaging. Comprehensive measurement of cumulative radiation exposure to~     patients may be critically important to minimize potential harm in future studies and in~     clinical practice.~   "
89141|NCT01890486|"~     To provide the IRB approved mechanism for the prospective collection, analysis and reporting~     of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem~     cell transplant for a disease in which a research question is not being addressed and for~     which peer reviewed, published data have demonstrated efficacy for this treatment approach.~   "
89142|NCT01890473|"~     The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of~     Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or~     the approved prefilled syringe.~   "
89143|NCT01890460|"~     The purpose of the study is to compare ultrasound measurements of the liver obtained prior~     to surgery on the skin to measurements obtained during surgery directly on the diseased~     liver. The objective is to determine if ultrasounds of the liver on the skin can provide~     accurate measurements of disease of the liver to provide an alternative option to liver~     biopsies.~   "
89144|NCT01890447|"~     This study aims to establish an effective method to inform parents or close relatives of~     newborns about the risk of pertussis transmission to newborns and the advantages offered by~     the cocooning strategy (vaccinating those who are in close contact with the newborn) by~     assessing the factors that affect the parents' decision-making to accept pertussis~     immunisation.~   "
89145|NCT01890434|"~     Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs~     and/or symptoms, will be invited to participate in the study. The duration for a subject in~     the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be~     required.~      The primary objective of this study is to demonstrate that sensitivity and specificity of~     gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum~     performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over~     unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD.~     The CMR images acquired with a uniform imaging acquisition software will be evaluated either~     against the results from routine clinical Coronary Angiography (CA) or Computed Tomography~     Angiography (CTA), which are the standard of reference.~      CMRI and CA/CTA images will be collected for an independent image review (blinded read).~   "
89146|NCT01890421|"~     Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs~     and/or symptoms, will be invited to participate in the study. The duration for a subject in~     the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be~     required.~      This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic~     Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion~     (specificity ) of coronary artery disease utilizing a uniform image acquisition software.~     The CMR images will be tested either against the results from routine clinical Coronary~     Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the~     standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment~     or be scheduled up to 4/6 weeks after the study.~      CMRI and CA/CTA images will be collected for an independent image review (blinded read).~   "
89147|NCT01890408|"~     Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver~     resection. But, opioids tend to be ineffective for pain that is associated with movement and~     have significant short-term side effects including nausea, vomiting, sedation, pruritus,~     constipation, urinary, retention, and respiratory depression, which are factors that often~     hinder a patient's recovery. Prospective randomized trials has found continuous wound~     catheter analgesia as an accepted alternative to IV morphine PCA.~      The researchers will investigate whether ropivacaine, administered through a wound catheter~     placed by the surgeon, will reduce morbidity and provide a better recovery.~   "
89148|NCT01890395|"~     To identify patients who may be predisposed for developing MOF (multiple organ failure)by~     the sampling of blood.~   "
89149|NCT01890382|"~     The combination of protein and resistance exercise seems to be one of the most effective~     tools to counteract sarcopenia. Randomized controlled trials supporting this possibility are~     still scarce. These series of clinical trials aim to investigate the therapeutic role of~     protein ingestion combined with resistance training in frail elderly participants. These~     studies will mainly address the following research questions: Is the protein source (i.e.,~     whey versus soy) a factor in inducing a differential anabolic response? Does dietary protein~     consumption dictate a whey/training-induced anabolic response? Does leucine supplementation~     promote anabolic response? Does co-supplementation of creatine and whey protein foster an~     anabolic response?~   "
89150|NCT01890369|"~     The investigators plan to explore the ability of amino acids, the building blocks of~     proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong.~     The investigators will investigate how rapidly after one meal the human body is ready to~     make use of a second meal and look at the molecular mechanisms underlying this. The~     investigators will look at these phenomena in older men as this group is known to be subject~     to a gradual loss of muscle mass and strength.~   "
89151|NCT01890356|"~     Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for~     depression and have shown promising efficacy. However, there is no published data to date on~     their effectiveness as a maintenance treatment. This study will investigate ways of using~     TES as a maintenance treatment to prevent relapse in depression.~   "
89152|NCT01890343|"~     Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as~     measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal~     volunteers and subjects with Alzheimer's disease (AD).~   "
89153|NCT01890330|"~     MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS~     is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low~     HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade~     chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.~      This study will investigate the effect of a 12 week intervention with canola oil versus the~     typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS~     parameters. CVD risk will be assessed based on the profile of lipids and other factors in~     the blood as well using specialized equipment for non-invasive monitoring of blood vessel~     function.~   "
92182|NCT01849627|"~     A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g~     and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily~     energy intake at estimated energy needs for maintenance) on weight loss maintenance.~   "
89155|NCT01890304|"~     To identify the changes in the brain following repeated sports-related concussion in men's~     football, women's soccer, and women's lacrosse college athletes by reviewing the findings of~     MRI studies that look at the structure of the brain and the appearance of the white matter~     at baseline, during the acute phase of a concussive injury, and upon completion of~     collegiate athletic play and correlate these findings with standard clinical measures.~   "
89156|NCT01890291|"~     To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment~     groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular~     carcinoma in Korea~   "
89157|NCT01890278|"~     In this study the patient will receive either whole brain radiation therapy given by~     intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT~     therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This~     study will look to see if this approach results in less hair loss or fewer memory Problems,~     as compared to the standard technique. The study will also look at the effectiveness of both~     techniques in controlling the growth of the tumor.~   "
89158|NCT01890265|"~     To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of~     FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in~     these subjects.~   "
89159|NCT01890252|"~     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal~     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,~     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal~     dystrophies as well as post-surgical conditions resulting from cataract extraction and~     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and~     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care~     professional.~      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if~     required.~      Prospective open-label, randomized, crossover clinical study To evaluate the safety and~     efficacy of the Hyper-CL™ lens in subjects suffering from corneal edema.~      This study is designed to evaluate the efficacy of the Hyper-CL™ lens contact lens on~     corneal edema thickness as compared with salt solution treatment only in subjects suffering~     from corneal edema.~      Treatment with the Hyper-CL™ lens may result with greater reduction in edema thickness as~     compared with treatment with salt solution only in subjects suffering from corneal edema.~      Men and women suffering from a decrease in vision due to corneal edema that meet the~     inclusion/exclusion criteria and provide written Informed Consent will be enrolled in the~     study.~      A total of 25 subjects will be enrolled. Each subject will be treated with:~        -  Treatment A: Hyper-CL™ lens only (7 days)~        -  Treatment B: Hyper-CL™ lens + salt solution (7 days)~        -  Treatment C: salt solution only (7 days) One week (7 days) of washout without any~          treatment will be between treatments. Subject will be equally allocated (with a~          1:1:1:1:1:1 ratio) to one of the following 6 crossover regimen based on a randomization~          scheme with blocks stratified by center: C-A-B; B-C-A; A-B-C; C-B-A; B-A-C; A-C-B.~      Up to 2 centers will participate in this study. Each subject will be followed from baseline~     to 42 days. All Subjects will come for a clinic visit at 7, 14, 21, 28, 35 and 42 days post~     first treatment.~      Completion of active enrolment is anticipated to last approximately 6 months. The primary~     end point will be achieved when the final study subject has completed 42 day follow-up.~   "
89160|NCT01890239|"~     BACKGROUND Demographic trends coupled with a rise in chronic diseases mean that the~     population of patients requiring palliative and end-of-life care is ageing. Due to the~     ageing population palliative care for older people has been identified as one of the~     worldwide public health priorities. A majority of elderly patients die in hospital. Studies~     from the United Kingdom and other countries have shown that many older persons dying in~     hospital experience suboptimal care. The Care Programme for the Last Days of Life has been~     developed to improve the quality of end-of-life care in acute geriatric hospital wards. The~     programme is based on existing end-of-life care programmes but modeled to the acute~     geriatric care setting. There is a lack of evidence of the effectiveness of end-of-life care~     programmes and the effects that may be achieved in patients dying in an acute geriatric~     hospital setting are unknown. The aim of this study is to evaluate the effectiveness of the~     Care Programme for the Last Days of Life in improving the quality of care and quality of~     life during the last 48 hours of life of patients dying in acute geriatric hospital wards in~     Flanders as compared to usual care.~      METHODS In order to contribute substantially to the increase of evidence for the effect of~     the Care Programme for the Last Days of Life in patients dying in acute geriatric hospital~     wards, a cluster randomized controlled trial will be conducted. Ten hospitals with one or~     more acute geriatric wards will conduct a one-year baseline assessment during which care~     will be provided as usual. For each patient dying in the ward, a questionnaire will be~     filled in by a nurse, a physician and a family carer. At the end of the baseline assessment~     hospitals will be randomized to receive intervention (implementation of the Care Programme)~     or no intervention. Subsequently, the Care Programme will be implemented in the intervention~     hospitals over a six-month period. A one-year post-intervention assessment will be performed~     immediately after the baseline assessment in the control hospitals and after the~     implementation period in the intervention hospitals. Primary outcomes are symptom frequency~     and symptom burden of patients in the last 48 hours of life.~      DISCUSSION This will be the first cluster randomized controlled trial to evaluate the effect~     of the Care Programme for the Last Days of Life for the acute geriatric hospital setting.~     The results will enable us to evaluate whether implementation of the Care Programme has~     positive effects on end-of-life care during the last days of life in this patient population~     and which components of the Care Programme contribute to improving the quality of~     end-of-life care.~   "
89161|NCT01890226|"~     Poor quality of medical care is a major contributor to excess medical morbidity and~     premature mortality in persons with serious mental illnesses (SMI). To address this problem,~     community mental health providers are increasingly partnering with safety net medical~     providers to develop behavioral health homes, integrated clinics in which persons with SMI~     receive coordinated medical and mental health care. However, behavioral health homes have~     faced logistical and privacy challenges in integrating electronic medical records across~     organizations.~      This application proposes to develop and test a mobile Personal Health Record (mPHR) to~     overcome this problem while more fully engaging patients in their health care. The study~     will develop, test, and disseminate the mPHR. The investigators will develop the app~     building on experience and preliminary data from a PC-based PHR project, and link it to the~     medical and mental health EHR in a behavioral health home. Next, the investigators will~     conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.~   "
89162|NCT01890213|"~     This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus~     replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers~     such as colon cancer in patients that have stage III colon cancer. We will also evaluate the~     patient immune response to the vaccine.~   "
89163|NCT01890200|"~     This is a randomized, double blind, multi-center, placebo controlled, three parallel arms,~     Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high~     dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV~     infection.~      This will be demonstrated by a higher sustained virologic response rate, defined as the~     absence of detectable HCV RNA 24 weeks after the termination of combination treatment,~     compared with the placebo add-on.~   "
89164|NCT01890187|"~     The objective of this study is to determine the repeatability and reproducibility of the~     Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).~   "
89165|NCT01890174|"~     The objective of this study is to determine the repeatability and reproducibility of the~     Cirrus HD-OCT measurements of drusen area and volume.~   "
89166|NCT01890161|"~     This is the first study in human patients with asthma that the sponsor is conducting in~     order to evaluate if there are signals that the investigational medication, AXP1275, may be~     a safe and effective treatment for asthma. The results of this study may help the sponsor to~     design additional studies.~   "
89167|NCT01890148|"~     Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after~     4 wk treatment with AZD 5069~   "
89168|NCT01890135|"~     Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in~     the arteries to leg reduce blood flow and one of the resulting problems is termed~     intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and~     IC is the most frequent clinical manifestation of PAD and it effects millions of Americans.~     The number of patients with, and the health care costs of, PAD will increase as the~     prevalence of PAD is associated with advancing age, diabetes, and smoking. Zibotentan~     (ZD4054) is an endothelin receptor A (ETA) blocker that undergone extensive human testing~     and has been shown to be safe in several patient population. There is ample evidence to~     suggest that an ETA blocker could improve blood flow to the legs in patients with PAD. In a~     study that will be funded by the National Institute of Health, the investigators will test~     the ability of this medication to allow better blood flow to the legs of patients with PAD.~     In patients with IC, the investigators will test the ability of ZD4054 to improve leg blood~     flow using a non-invasive imaging technique. In parallel the study will test for the ability~     of patients with leg pain to walk further and feel better.~   "
89169|NCT01890122|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin~     fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2~     Diabetes Mellitus (T2DM).~   "
89170|NCT01890109|"~     This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in~     female subjects with HFs associated with menopause. This study will evaluate the efficacy of~     AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at~     weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.~   "
89171|NCT01890096|"~     A single high dose rate brachytherapy (HDR) treatment combined with a short course of~     external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men~     with intermediate risk prostate cancer. High cancer control rates have also been reported~     with HDR used on its own, without the EBRT. The challenge has been to determine what HDR~     dose to use with a move towards one or two fractions by several investigators. These~     schedules are reported to be well tolerated in the short term, but with little long term~     data. The objective of this study is to investigate HDR monotherapy given as either one~     fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The~     primary endpoint is patient reported toxicity and health related quality of life at 1 year,~     and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which~     we expect to accrue within 18 months.~   "
89172|NCT01890083|"~     Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α~     treatment results in a significant increase in depressive symptoms. The aim of this project~     is to compare two health interventions (exercise vs. health education) to prevent depression~     in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for~     Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or~     a health education control group.~   "
89173|NCT01890070|"~     The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods~     conforming to the Mediterranean diet, in order to determine the effect functional foods have~     on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function,~     inflammation, nutritional status) and body composition in the context of four different~     diets (standard, high fat, high protein, low carbohydrate). The study focuses on the effect~     of these nutraceutical foods in relation to different diets. Diets were chosen to reflect~     the standard reference diets used by the general population, so as the outcomes of the~     addition of each interventional food element may be interpreted in the context of a variety~     of dietary patterns.~   "
89174|NCT01890057|"~     To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes~     from profound rocuronium-induced neuromuscular block in young and elderly adult patients.~   "
89175|NCT01890044|"~     Venous thromboembolism (VTE) remains a leading cause of death in trauma patients. Based on~     the EAST Management Guidelines for the prevention of VTE in trauma patients, a number of~     research questions could be addressed by a thorough current literature review combined with~     a multicenter concurrent analysis. This proposal seeks to create a data registry of trauma~     patients from multiple trauma centers around the United States that will serve as a platform~     for the study of VTE.~   "
89176|NCT01890031|"~     The purpose of this study is to show that we can effectively deliver health information and~     education, online, via computer regarding cholesterol. This computer program is called the~     Interactive Cholesterol Advisory Tool (ICAT).~   "
89177|NCT01890018|"~     The overall objectives of this study are to improve medication adherence of patients and~     subsequent health outcomes.~      This study is designed to examine the existence of strong associations between social~     networks and health behavior. This study intends to demonstrate that social forces are~     particularly effective at building enduring habits for healthy behavior, specifically~     adherence to statin medication for this study. The investigators believe the improved~     medication adherence will result in fewer additional vascular events, following the most~     recent of these events, and will result in fewer patient hospitalizations. The investigators~     will leverage insights from the fields of social comparison (being provided with information~     about the actions of others prompts social comparison that can significantly influence~     behavior), social pressures (encouragement or discouragement from others is a powerful~     social force that can influence individual behavior), and social triggers (cues in the~     environment can motivate people to take certain actions and have powerful effects on~     purchasing behavior).~      The results of this study and experience gained from the implementation of these~     interventions will be used to inform new versions of a larger trial intervention to be~     tested in new patient cohorts in a rapid cycle framework.~   "
89178|NCT01890005|"~     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over~     the world. The use of low dose aspirin has been mentioned in several studies with promising~     results. The investigators decided to evaluate the use of low dose aspirin, starting between~     13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence~     of preeclampsia.~   "
89571|NCT01884896|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
89179|NCT01889992|"~     Cardiac allograft remodeling causes poor quality of life, allograft failure and increased~     mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its~     progression are poorly defined and there is a need for effective interventions.This is a~     multi-factorial phenomenon, associated with various immunological and non-immunological~     factors. Animal studies suggest M-TOR inhibition attenuates cardiac allograft remodeling~     secondary to down-regulation of M-TOR downstream targets and increased autophagy. There is a~     paucity of data regarding effect of Sirolimus, a M-TOR inhibitor, on human heart remodeling.~      This aim of the proposal to identify the prevalence of cardiac allograft remodeling on~     current immunosuppressive strategies and determine risk factors for its development. It will~     also identify molecular pathways associated with cardiac allograft remodeling and determine~     the impact of Sirolimus on these pathways.~   "
89180|NCT01889979|"~     Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately~     severe pain. It has been previously evaluated as a method to reduce pain during labour, but~     there is always some fear related to its effects (neonatal respiratory depression). The~     purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to~     pain during labour, duration of labour and neonatal outcomes.~   "
89181|NCT01889966|"~     Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of~     pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether~     the acute response to this treatment (= vasoreactivity testing) given intravenously is~     effective and allows prediction of therapy success during a following oral treatment.~   "
89182|NCT01889953|"~     This research is being done to study the safety and feasibility of recruiting patients~     eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety~     and effectiveness of this procedure.~   "
89183|NCT01889940|"~     The purposes of the ESPELMA project are twofold: 1) To increase acute spinal cord injury~     patients' satisfaction with treatment while hospitalization and 2) To increase mastery among~     rehabilitation professionals with regard to the clinical management of patients'~     psychological distress.~      For these purposes, a tailored training for professionals will be designed and offered.~      It is hypothesized that building capacity among professionals will serve to better~     management of patients' distress and a greater ability to commit them to the rehabilitation~     process. Thus, it is expected to lead to better and faster functional recovery and~     consequently to higher perceived satisfaction with treatment.~   "
89184|NCT01889927|"~     The primary aim of the research is to evaluate whether an alternative model of cystic~     fibrosis (CF) physiotherapy care can produce statistically significant improvements in~     clinical and patient reported outcomes, and whether this alternative model is economically~     advantageous and/or sustainable.~      Children randomised to the control group will receive 24-months of current model of CF care~     at Great Ormond Street Hospital (GOSH).~      Children randomised to the intervention group will receive 24-months of current model of CF~     care at GOSH PLUS a weekly structured, individually prescribed and personally supervised~     exercise intervention at a local fitness facility or at school. The exercise prescription~     will include aerobic, anaerobic, strength, core conditioning and stretching components.~      The main objectives of the study are:~        1. Determine differences, if any, in lung function between the two groups;~        2. Determine differences, if any, in exercise capacity between the two groups;~        3. Evaluate cost of care of alternate model of care versus current model of care.~   "
89185|NCT01889914|"~     The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.~      In our future study, the investigators wish to study if the treatment by continuous infusion~     of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators~     indeed expect that the insulin delivered in a continuous way decreases the~     insulino-resistance of these patients compared with the intermittent delivering of insulin.~   "
89186|NCT01889901|"~     Epilepsy is common in childhood. Throughout life, including adulthood, children with~     epilepsy are at increased risk of impaired health, functioning, psychological well-being and~     quality-of-life. There is evidence that physical activity improves the medical and~     psychosocial aspects of health in adults with epilepsy- but there are no such studies in~     children. The investigators predict that we can increase levels of physical activity and~     influence children's functioning, psychological well-being and quality of life through~     multiple pathways. The investigators propose to evaluate the relationship between enhanced~     physical activity and health, and explore facilitators and barriers to physical activity in~     children with epilepsy.~   "
89187|NCT01889888|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time endoscopically into submucosal layer of~     urethra under eye control into the stricture site after mechanical dilation. This is a~     single arm study with no control. All patients receive cell therapy.~   "
89188|NCT01889875|"~     Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g.~     antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be~     delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. The~     study seeks to compare immunological changes during subcutaneous (SCIT) and sublingual~     tablet (AIT) immunotherapy of grass pollen allergy (hayfever).~   "
89189|NCT01889862|"~     The BMN 165 clinical development program has been designed to demonstrate the safety and~     efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.~   "
89199|NCT01889732|"~     Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation~     disorder undergoing surgery. Recently, there are some reports about prediction of~     perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and~     improve outcomes is still debate. In this retrospective study, the investigators will~     compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach,~     and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.~   "
89200|NCT01889719|"~     This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are~     safe and whether they will boost immune responses generated by immunizations with a~     dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy~     HIV-uninfected volunteers.~   "
89190|NCT01889849|"~     This research protocol Comparative pharmacokinetics and pharmacodynamics of peginterferon~     Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy~     volunteers. This is a Phase I clinical trial which will compare pharmacokinetic and~     pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®)~     and BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of~     4 weeks. The study population will be 32 healthy male volunteers to whom will be~     administered a single dose of 180 microgram of each product, subcutaneously. The study will~     have a total duration of 14 days in each treatment step. The serum concentration of~     PEG-interferon for both products, measured by enzyme immunoassay (EIA) and by antiviral~     activity of PEG-interferon, is the main variable.For this purpose 15 samples of each~     volunteers will be needed. Clinical and laboratory variables, useful as pharmacodynamics~     parameters Beta-2 microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate~     synthetase (OAS)- and neopterin) and safety evaluation, will be measured.~   "
89191|NCT01889836|"~     Clinical trial phase I, randomized, double blind, where 30 individuals will receive the~     experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate~     vaccine already licensed in Brazil and available in the National Immunization Program for~     children less than 12 months of age. The primary outcome of the study is to evaluate the~     safety profile of the vaccine under test, which should allow its application in humans.~     Secondly, the investigators will study its immunogenicity from the evaluation of the~     correlates of seroprotection for meningococcal, defined by the World Health Organization~     (WHO).~   "
89192|NCT01889823|"~     It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory~     effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could~     be the result of activation of Hypoxia Inducible Factor, a transcription factor that is~     known to activate many cell systems aimed at cell survival, including the inflammatory~     response. The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia~     Inducible Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a~     decrease in clearance of pathogens. These effects have been sparsely studied in humans.~     Therefore, we hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in~     circulating leukocytes and increases inflammatory reactions, whereas hyperoxia decreases~     these reactions.~   "
89193|NCT01889810|"~     Insulin resistance is a state where the body does not respond as it should to the insulin it~     produces. Individuals who are insulin resistant are at increased risk of both heart disease~     and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease,~     independent of other recognised risk factors. Interventions that prevent or reverse insulin~     resistance may help to attenuate risk of heart disease and diabetes. A number of randomised~     controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin~     D on insulin resistance and other cardiovascular risk markers but experts have stated that~     further studies are required. Importantly, these studies should use appropriate endpoints,~     provide a high enough dose of vitamin D to optimise vitamin D status, and they should be~     conducted in clearly defined populations, The vitamin D trial we propose addresses these~     issues and aims to evaluate a potentially straightforward and low cost health care~     intervention for populations at highrisk of heart disease and diabetes. Specifically, this~     study would provide clinically relevant information on the metabolic effects of optimising~     vitamin D status in these high risk patients. This has clear economic and social~     implications given the current, and projected, burden of heart disease and diabetes.~      This study will investigate the effect of vitamin D3 supplementation on insulin resistance~     and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular~     disease using the gold standard euglycaemic hyperinsulinaemic clamp method.~   "
89194|NCT01889797|"~     Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL)~     will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to~     determine response.~      Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug~     Administration in 1998 for the treatment of patients with relapsed low-grade B-cell~     lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and~     effective in previously untreated as well as relapsed patients with low-grade lymphoma.~      GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been~     shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct~     cell-death induction compared to Rituximab. It is possible that GA101 may have greater~     efficacy than rituximab.~      PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters~     in Patients Participating in GA101 (Obinutuzumab)~      Approximately twenty-five patients randomized to GA101 may participate in the sub-study.~     Electrocardiograms and blood samples will be obtained.~   "
89195|NCT01889784|"~     The purpose of this study is to determine the phototherapy may be adjuvant to exercise to~     improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy~     adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that~     have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in~     exercise tests. Two doses will be tested 150J and 300J.~      Additionally, this study aims to evaluate the effect of phototherapy previously applied to~     the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously~     applied to the exercise will result in the increase baroreflex sensitivity (increased~     coherence and gain and decreased phase), promoting the improvement of the cardiovascular~     autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested~     150J and 300J.~   "
89196|NCT01889771|"~     The study is to understand whether distribution of two different supplies of nicotine~     patches through a telephone quitline has an effect on quit rates. The two different supplies~     are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The~     hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more~     cost-effective.~   "
89197|NCT01889758|"~     The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and~     the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully~     replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36)~     subjects.~   "
89198|NCT01889745|"~     This study is designed to multiple dose and dose escalation study~   "
89243|NCT01889160|"~     Study to investigate the safety profile of AZD4721 after single doses at different dose~     levels~   "
89201|NCT01889706|"~     The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and~     excess weight. This leads to the development of insulin resistance, even in patients with~     type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as~     adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in~     overweight and obese patients with type 1 diabetes mellitus.~      The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose~     tissue content as measured by electrical bioimpedance, treated at the Poznan University of~     Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes~     diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This~     group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100~     patients are treated with insulin alone (control group, group I). Metformin is administered~     at least 6 months at a mean dose of 1000 mg/day.~      The investigators would like to assess the impact of metformin treatment on metabolic~     control, insulin resistance and anthropometric parameters in overweight and obese patients~     with type 1 diabetes.~   "
89202|NCT01889693|"~     Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with~     positron emitter is not yet available. Fortunately, some scientists made the major advance~     in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter~     agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque~     macrophages in carotid arteries. However, coronary and cerebral arterial segments remain~     uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal~     mannose residues of MSA binding with the mannose receptors of macrophages in~     atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive~     molecular imaging of atherosclerotic lesion in PET.~   "
89203|NCT01889680|"~     FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with~     ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6~     and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer.~     The primary aim of the study is to determine the value of adding ziv-aflibercept to the~     continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients~     with metastatic colorectal cancer who have achieved at least stable disease after induction~     therapy. The secondary aim is to determine the overall objective response rate (complete,~     partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).~   "
89204|NCT01889667|"~     The purpose of this study is to test the safety and pharmacodynamics of an oral formulation~     of insulin in subjects with Type 2 Diabetes.~   "
89205|NCT01889654|"~     Lupus disease is characterized by the production of pathogenic autoantibodies, which~     participate in end-organ damages. The phenotype of B cells producing the pathogenic~     autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are~     characteristic of lupus disease.This project proposes to detect antinucleosome B cells in~     lupus patients and to analyse their phenotype and their frequency.~   "
89206|NCT01889641|"~     Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy,~     underscoring the need to better dissection of the pathogenic mechanisms. Concordant with~     preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could~     be a marker of the disease activity and then a potential therapeutic target. In the present~     study, serum IL 26 level in lupus patients and control will be measured.~   "
89207|NCT01889628|"~     Nutritional formula drinks are widely consumed in Asia especially by those having chronic~     illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood~     glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese,~     Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas~     differs between ethnic groups. Therefore the aim of this study is to observe if there are~     ethnic differences in the blood glucose response to nutritional formula drinks.~   "
89208|NCT01889615|"~     The investigators want to compare the use of MRI with PET/CT preformed after 1 hour and 3~     hours in preoperative assessment of resectability.~      The investigators' hypothesis is that dual time PET/CT performed at 60 and 180 minutes will~     increase the diagnostic accuracy of conventional PET (performed at 60 minutes) in~     preoperative assessment of resectability.~      Further more the investigators suggest that the GLUT/G6Pase index correlates to the SUVmax.~     And retention index (RI, see Methods - PET protocol) is a prognostic marker in ovarian~     cancer.~   "
89209|NCT01889602|"~     Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a~     mild, untoward effect on an essential function such a linguistic behavior, a directly~     observable product of complex cognitive processes, is disruptive to daily life.~     Nevertheless, the mechanisms underlying a drug's impact on cognition are poorly understood.~     This lack of understanding impedes the ability to predict both the effects of drugs in~     development and the degree to which an individual is vulnerable to the cognitive impact of a~     particular agent. Topiramate (TPM, an antiepileptic drug) is, with increasing frequency,~     being prescribed for a range of conditions including migraine prophylaxis, obesity and pain.~     It is a prime example of a drug that causes speech and language problems severe enough in~     some patients to result in discontinuation of therapy. For reasons not well understood, TPM~     has a poorer cognitive profile than many of the older antiepileptic drugs. The~     investigators' rational for this study is that it will offer insight into the mechanisms~     underlying drug-induced cognitive deficits.~   "
89210|NCT01889589|"~     This surveillance project will assess NYC population sodium intake using the gold standard~     measurement of 24-hour urine collection. This surveillance project is a critical component~     of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through~     voluntary industry reductions in processed food sodium content. The project will assess~     current population sodium intake, against which population intake changes at three years can~     be assessed~   "
89270|NCT01888809|"~     This study will evaluate the effectiveness of providing a combination of evidence-based~     behavioral health treatments for mothers who gave birth to their first child prior to the~     age of 21 and who meet eligibility requirements and their children on prevention of child~     maltreatment and promotion of positive socioemotional development.~   "
89271|NCT01888796|"~     Examination of the effect of Linagliptin versus placebo on diastolic function in patients~     with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic~     echocardiography.~      Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be~     investigated.~   "
89211|NCT01889576|"~     Hypomagnesemia is common early after transplantation, especially in association with~     calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves~     glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without~     diabetes but this was never evaluated in transplant recipients.~      The aim of the study is to assess whether magnesium improves glycemic control and insulin~     sensitivity early after transplantation.~      The study is an open label study in which adult hypomagnesemic renal transplant recipients~     are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no~     supplementation.~      The hypothesis is that magnesium supplementation in renal transplant recipients exerts a~     beneficial effect on glycemia and the development of diabetes after transplantation.~   "
89212|NCT01889563|"~     To contrast the potential effects of physical exercise training program (PTP) of a 6 versus~     12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability~     (HRV) indices and functional capacity in moderate-to-severe COPD patients.~   "
89213|NCT01889550|"~     The research aims at generating new knowledge about ways to inform pregnant women about~     prenatal screening for Downs syndrome.~      The overall purpose of this project is to increase pregnant women's knowledge of prenatal~     screening for Downs syndrome, and thereby an option to make an informed choice. The project~     is planned as a research into whether the use of an eHealth solution (in this project an~     interactive website) may be an appropriate intervention for pregnant women.~   "
89214|NCT01889537|"~     The purpose of the research is to see whether a low dose of ketamine, a medication used to~     reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a~     form of distraction from pain during a painful burn care procedure.~   "
89215|NCT01889524|"~     In vivo deposition studies of aerosol administration during noninvasive ventilation are~     scarce in the current literature.~      We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy~     aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the~     different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered~     using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive~     ventilation (NIV).~   "
89216|NCT01889511|"~     The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale~     health-related research project on text messages to improve adherence to oral chemotherapy~     agents. Michigan State University College of Nursing has not been a major recipient of~     National Institute of Health grant funding. As a result, the overall objective of this~     proposal is to strengthen the research environment in the College of Nursing so that it can~     develop into a significant health-related scientific research enterprise. This project would~     involve undergraduate and graduate students, and thus, generate student interest in research~     as a career. The importance of the research planned for this proposal is as follows. More~     than 50 oral chemotherapy agents in pill form are currently on the market, with projections~     that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to~     achieve a therapeutically effective level for cancer treatment, patients must strictly~     adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be~     inadequate for treating the cancer. To date, empirical research in the area of improving~     adherence to oral agents is underdeveloped. The goal of this research is to improve~     adherence to oral chemotherapy agents through a technology based strategy, tailored SMS text~     messages. This prospective randomized controlled trial will examine the feasibility,~     acceptability, and satisfaction with a 3-week tailored text message intervention for oral~     agent adherence. Descriptive statistics, generalized linear modeling, and generalized~     estimating equations will be used for analysis. In this proposal, preliminary data will be~     collected to examine efficacy of the text message intervention to promote adherence to oral~     agents. Data will then be used to further inform the development of an intervention to~     improve adherence to oral agents for an R01 application to conduct a larger randomized trial~     to test this innovative intervention. This study can have a transformative impact on oral~     agent adherence by developing a technology-based strategy to promote adherence among the~     increasing number of cancer patients who receive their cancer treatment in pill form. This~     type of novel intervention also has the potential to transform and impact many other ill~     populations that require adherence to a medication regimen.~   "
89217|NCT01889498|"~     The aorta is a large vessel that carries blood away from the heart. Sometimes it becomes~     dilated (swells) and this is known as 'aneurysm'. It may cause either dissection (splitting~     of the wall) or rupture (bursting).~      Treatments could be through open surgery or by use of stents (tubular mesh) through the~     groin. There is a risk of causing paraplegia, which is the loss/weakness of leg function as~     well as incontinence (loss of bladder and/or bowel control).~      To try and prevent this, a number of techniques are used such as removing/draining of~     cerebrospinal fluid (CSF) (the clear fluid surrounding the brain and spinal cord).~      Sometimes however;~        -  CSF cannot be drained~        -  drain cannot be inserted~        -  draining is unlikely to improve the situation~        -  Paralysis/weakness of the leg is seen~      In these situations, the use of a drug called acetazolamide may be helpful. This reduces the~     production of CSF and therefore decreases the need for CSF draining. It may also have an~     effect in decreasing the risk of paraplegia.~      Patients will be randomly (by chance) placed into one of two groups. One will get the drug~     as tablets and injection and the other will not receive any acetazolamide at all. Blood~     tests will be done in both groups. We expect to have 100 patients in the study, with patient~     involvement for a total of 10 days (maximum).~   "
89218|NCT01889485|"~     This is a pilot study designed to validate our methods of recruitment, screening and data~     collection in the community. The project will help to establish the feasibility of the study~     design to lay the groundwork for a potentially larger study. The final study will allow us~     to estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery~     stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban~     setting, as well as determine patient access to healthcare and treatment for vascular~     disease as related to geographic and racial differences.~   "
89219|NCT01889472|"~     CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used~     in case of mouth leaks but these are associated with higher positive pressure needs and~     lower compliance to treatment. The present investigation evaluates if CPAP compliance would~     increase when an oral appliance is used in combination with a nasal mask compared to the use~     of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using~     an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one~     of the above-detailed interfaces for 4 weeks and data will be extracted from the machine~     report in each condition.~   "
89220|NCT01889459|"~     The purpose of this study is to establish a consensus of treatment strategy of percutaneous~     coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of~     PCI for CTO performed by Japanese certified operators.~   "
89272|NCT01888783|"~     This study aims to investigate whether two different measures of tactile acuity lead to~     comparable results in patients diagnosed with CRPS Type I of the upper extremity.~     Additionally patients with a neuropathy of the median nerve and healthy controls are~     included.~   "
89221|NCT01889446|"~     Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or~     additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it~     safe and therefore, has no limitation on its use. Since PA has been shown before to serve as~     a substrate for glucose production in the liver, the purpose of this study is to find out if~     PA intake causes changes in levels of glucose, insulin and other important hormones~     following a meal.~      This research study will compare PA to placebo. The placebo looks exactly like the active~     substance, but it does not contain any active agent (PA). Placebos are used in research~     studies to see if the results are due to the study drug or to other reasons.~      The investigators plan to have 20 subjects take part in this study at the Brigham and~     Women's Hospital (BWH).~   "
89222|NCT01889433|"~     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with~     ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic~     hepatitis C.~   "
89223|NCT01889420|"~     This study is being conducted to test the possibility that a combination of three drugs,~     pomalidomide and everolimus with dexamethasone, may improve patient responses when compared~     with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.~   "
89224|NCT01889407|"~     Whether Idarubicin can overcomes multidrug resistant 1 induced chemoresistance with higher~     induction remission rate than daunorubicin in de novo acute myeloid leukemia~     patients.Whether induction therapy with IA regimen has a higher remission quality with AML~     patients than that of DA regimen in high MDR1 expression AML patients.~   "
89225|NCT01889394|"~     To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing~     following excision of a pilonidal sinus.~   "
89226|NCT01889381|"~     Background: The human face is critically important for breathing, eating, seeing, and~     speaking/ communicating, but its most important job may be to look like a human face.~     Devastating facial deformities often cause affected individuals to avoid human contact and~     disappear from society. Although current surgical advancements can somewhat restore facial~     defects, this process often requires many operations and the resulting face only resembles~     the human face. To date, over 20 face transplants have been performed with highly~     encouraging functional and aesthetic results, but widespread clinical use has been limited~     due to the adverse effects of life-long and high-dose immunosuppression needed to prevent~     graft rejection. Risks include infection, cancer, and metabolic problems, all of which can~     greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the~     potential benefits of face transplantation.~      Study Design: This non-randomized, Phase II clinical trial will document the use of a new~     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face~     transplantation as a safe and effective reconstructive treatment for devastating injuries/~     defects by minimizing maintenance immunosuppression therapy in face transplant patients.~     This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has~     enabled graft survival using low doses of a single immunosuppressive drug followed by~     weaning of treatment. Initially designed for living-related solid organ donation, this~     regimen has been adapted for use with grafts donated by deceased donors. The investigators~     propose to perform 15 full or partial human face transplants employing this novel protocol.~      Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive~     strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of~     rejection and enable allograft survival while minimizing the requirement for long-term,~     high-dose, multi-drug immunosuppression.~      Significance of Research: Face transplantation could help injured individuals recover~     functionality, self-esteem, and the ability to reintegrate into family and social life as~     whole individuals. This protocol offers the potential for minimizing the morbidity of~     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this~     life-enhancing procedure and enabling a wider clinical application of face transplantation.~   "
89227|NCT01889368|"~     In people with the metabolic syndrome, the investigators hypothesize that administration of~     a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well~     cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized~     LDL in the blood during a 24 hour period. These measurements will be assessed at hourly~     intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize~     that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin~     resistance, oxidative stress, and the level of oxidized LDL in the blood.~   "
89228|NCT01889355|"~     This enhanced meter feature raises awareness among patients by providing additional~     information regarding their glycemic control in between Healthcare Professional visits. This~     information may facilitate increased dialogue between patient and Healthcare Professional~     and can remind patients of the importance of glycemic control.~      This study will evaluate a user's ability to use the enhanced meter feature.~   "
89229|NCT01889342|"~     Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic~     model and could therefore be well suited when it comes to treating patients with high rates~     of comorbidity. So far, no studies have examined MCT in comparison with the best documented~     and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized~     controlled trial consisting of mixed anxiety disorder sample with high degree of~     comorbidity.~      The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a~     sample of mixed anxiety disorders as compared to a group receiving existing evidence-based~     single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change~     in the two treatments.~   "
89230|NCT01889329|"~     Around 0.5 million under-five children are currently suffering from severe acute~     malnutrition (SAM) in Bangladesh and are at risk of death. Children with SAM and~     complications should be treated in a health care facility. It is imperative, however, to~     manage children with SAM but without any complications in the community. This requires a~     ready-to-use-therapeutic food (RUTF) that conforms to standard recommendations on its~     composition. The prototype RUTF is peanut based, made outside Bangladesh, and has to be~     imported. By developing a RUTF using local food ingredients, test it for acceptability and~     efficacy in the treatment of children with SAM, hopefully make the treatment of SAM~     cost-effective and sustainable.~      Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate~     similar or better acceptability and efficacy in the treatment of children suffering from~     severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?~   "
89231|NCT01889316|"~     This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing~     in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii~     (a newer device also created by Monica Healthcare) using the same technology with different~     monitor placement.~   "
89273|NCT01888770|"~     The purpose of this study is to investigate whether exposure to hypertensive disorders of~     pregnancy and/or a preterm birth results in alterations in the cardiovascular system during~     infancy.~   "
89274|NCT01888757|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
89232|NCT01889303|"~     Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall~     survival and disease-free survival according to Intergroup Trial 0116 in patients with~     gastric cancer after surgical resection. However,there are still many patients experiencing~     local recurrence or distant metastasis after adjuvant chemotherapy and concurrent~     chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and~     standard regimen for adjuvant treatment has not been established in locally advanced gastric~     cancer yet.The investigators designed the trial to investigate the efficacy and safety of~     docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy~     regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as~     chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.~   "
89233|NCT01889290|"~     -  Assessment of pharmacokinetic parameters of once daily subcutaneously administered~          methylnaltrexone in 10 evaluable neurointensive care patients.~        -  Quantification of methylnaltrexone passage through the blood-brain-barrier in~          critically ill patients with severe cerebral affections.~        -  Observation of laxation response after methylnaltrexone application and relation to~          plasma concentrations of methylnaltrexone.~        -  Assessing the safety of once daily administered methylnaltrexone in neurointensive care~          patients.~        -  Trial with medicinal product~   "
89234|NCT01889277|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of~     MT-3995 in Subjects with Diabetic Nephropathy~   "
89235|NCT01889264|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,~     while muscle and structural protein synthesis is decreased. The metabolism of sulfur amino~     acids through the splanchnic area and specifically methionine and cysteine have not been~     investigated in critically ill septic children, despite that sulfur amino acids have~     important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in~     sick children will be influenced by its rate of utilization through different pathways. Our~     study aims to investigate the metabolism of methionine and cysteine when both amino acids~     are given by the enteral route in critically ill septic children. The investigators are~     focused on the rates of transmethylation, remethylation and transsulfuration in critically~     ill septic children, and if the current standard nutrition maintains methionine nutritional~     balance and functional requirements in critically ill children fed by the enteral route.~   "
89236|NCT01889251|"~     The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion~     (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to~     sham-injection in subjects with symptomatic VMA.~   "
89237|NCT01889238|"~     The purpose of this study is to determine if enzalutamide is safe and effective in the~     treatment of patients with advanced breast cancer that express the androgen receptor but do~     not express the estrogen or progesterone receptor and are not Her2 amplified.~   "
89238|NCT01889225|"~     Previous analyses of the National Health and Nutrition Examination Survey have suggested~     that the mortality rate associated with obesity has decreased over calendar time in the U.S.~     population, potentially due to improvements in the medical care of obesity and its~     associated diseases. The primary aim of this project is to evaluate whether this reduction~     in the detrimental association of obesity with mortality rate over calendar time is~     supported by other data from U.S. prospective studies.~   "
89239|NCT01889212|"~     New treatment strategies have been developed in lung cancer targeting the Epidermal Growth~     Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds~     rates to the treatment and should be treated with a EGFR inhibitor as first line of~     treatment. Some wild type patients do as well respond but selection of these patients is~     more difficult.~      Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the~     tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.~      The investigators now want to conduct a larger clinical study to evaluate if accumulation of~     tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.~   "
89240|NCT01889199|"~     The purpose of this research study is to collect specimen samples and study medical~     information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The~     goal is to learn more about the changes that take place in the body that result in PCOS.~      We anticipate that 59 women will take part in this study (15 without PCOS and 44 with PCOS).~     All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If~     they meet the criteria for this study, they will then undergo additional blood tests,~     removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat~     (i.e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test~     (FSIGTT), and determination of ovarian function (via a follicle stimulating hormone [FSH]~     test). The women without PCOS will be complete the study at this point.~      The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo.~     They will take the drug every day for six 28-day cycles. They will be asked to collect and~     store a urine sample once a week. They will also be asked to complete a pill diary and~     menstrual diary. Once a month while they are taking the flutamide/placebo, they will return~     to the clinic and bring their frozen urine samples. At that time they will undergo a~     physical exam, toxicity assessment, and blood draw.~      Quality of Life assessments will be done at the beginning of the study for all participants.~     Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality~     of Life assessments during the study and at the end of the study.~      Six months following the completion of protocol procedures, participants who received~     flutamide/placebo will be contacted by phone to check on the status of their health. They~     will be asked if they have experienced any health problems or have become pregnant since~     they completed the study procedures.~      After the six 28-day cycles are completed they will then undergo additional blood tests,~     removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat~     (i.e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test~     (FSIGTT), and determination of ovarian function (via a FSH test).~   "
89241|NCT01889186|"~     This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety of~     ABT-199 in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.~     One hundred seven (107) subjects were enrolled in the main cohort, with evaluation of~     efficacy as the primary objective, and approximately 50 subjects will be enrolled in the~     safety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis and~     management measures. Enrollment into the main cohort is closed. Enrollment into the safety~     expansion cohort is closed.~   "
89242|NCT01889173|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of 3~     different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine~     designed to result in increased dosage precision and decreased potential for morning~     grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8~     mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and~     TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).~   "
89244|NCT01889147|"~     In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be~     investigated. Alkaline Phosphatase is naturally present in the body and reported to use~     lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from~     damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes~     alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated~     diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP)~     has previously been investigated for treatment of acute inflammatory responses such as~     sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the~     current study, is expected to have a longer half-life in humans than the previously~     investigated BIAP, due to the fact that it is more sialylated. The possibility to increase~     the t1/2 to days instead of minutes enables treatment of chronic diseases.~   "
89245|NCT01889134|"~     The purpose of this study is to determine whether osteoprotegerin and RANKL (receptor~     activator of nuclear factor-κB ligand) are involved in bone remodeling in patients with~     primary hyperparathyroidism (PHPT), and whether alendronate may be useful in treatment of~     the patients with PHPT who are not treated with parathyroidectomy.~   "
89246|NCT01889121|"~     Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance~     program enhances the outcome of pregnancies for the mother and the infant. Our objective was~     to assess if provision of structured psychosocial support in addition to methadone~     maintenance program adds incremental benefits with regards to the outcome of pregnancy.~   "
89247|NCT01889108|"~     The proposed feasibility study will evaluate the investigators ability to conduct a clinical~     trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature.~     Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from~     current early intervention practices in 2 important ways. First it bridges the traditional~     gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and~     intensive support for developmental activities when parents are establishing care giving~     routines. Second, in contrast to wide-ranging intervention provided by current early~     intervention models, SPEEDI uses an action perception model to target specific behaviors~     which lead to improved early motor abilities and provide a foundation for learning.[6] The~     purpose of this feasibility study is to extend the investigators preliminary data and~     evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy~     of SPEEDI.~   "
89248|NCT01889095|"~     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle~     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail~     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are~     generated to improve glycemic control .New insulin analogs are generated to improve glycemic~     control,However, the cost of these analogs is a major problem .The aim of this piggy back~     evaluation was to assess the effect of BIAsp 30 versus NPH plus regular human insulin on~     metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the~     Iranian setting.~   "
89249|NCT01889082|"~     A randomized pilot study will be conducted, the goal of which is to determine which format~     represents the most viable approach to behavioral weight loss treatment with 18-25 year~     olds. Specifically, participants will be randomized to one of three arms; all arms will~     receive a 12-week behavioral weight loss intervention, including identical dietary, physical~     activity, and weight loss prescriptions.~   "
89250|NCT01889069|"~     This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetics~     of subcutaneous (SC) MabThera/Rituxan (rituximab) in previously untreated patients with~     CD20+ diffuse large B cell lymphoma (DLBCL) or follicular lymphoma (FL). Patients will~     receive in addition to standard chemotherapy, in the induction phase of the study~     subcutaneous doses of 1400 mg MabThera/Rituxan once a month for at least 4 cycles, and in~     the maintenance phase subcutaneous doses of 1400 mg MabThera/Rituxan once every two months~     for at least 6 cycles.~   "
89251|NCT01889056|"~     The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the~     brain, especially under hypoxic conditions. It has been shown in animal studies and human~     studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence~     for central modulatory effects of Epo in the brain but high dose of Epo is needed to~     overcome the blood brain barrier. In a double blind placebo controlled crossover study we~     will investigate the effects of a single high dose of Epo on cognitive function and exercise~     capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000~     IU) and will perform a computerized cognitive test battery, a breathing test, a maximal~     exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The~     primary outcome of the study will be the cognitive function.~        -  Trial with medicinal product~   "
89252|NCT01889043|"~     Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in~     patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be~     impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research~     has been performed on the quality of sleep in patients with ALS when using NIV, and these~     data are mainly based on patient reported outcomes.Further on, only very little research has~     been done on patient-ventilator interaction.~      Our study would like to perform research on quality of sleep before and after NIV use by~     using full polysomnography with incorporation of transcutaneous carbon dioxide measurement~     and built-in ventilator software.~   "
89253|NCT01889030|"~     This is an observational, cross-sectional, national multicenter study, trying to obtain~     local data about the global cardiovascular risk profile of patients attending ambulatory~     offices of general practitioners and cardiologists.~      The aim of the study is to describe how physicians diagnose and stratify their patients in~     cardiovascular primary prevention setting and to highlight if patients are stratify through~     objective tools (risk scores and in this case, wich of them are used) or in subjective ways~     (clinical evaluation).~   "
89254|NCT01889017|"~     Extent of use of generics immunosuppressive drugs in clinical practice after lung~     transplantation~   "
89275|NCT01888744|"~     The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD~     and for this reason we plan a randomized controlled trial (RCT) comparing~     gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The~     follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH~     (Menopur®).~   "
89255|NCT01889004|"~     The explanation of consciousness poses one of the greatest challenges to science and~     philosophy in the 21st century. It remains unclear what consciousness is and how it emerges~     from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what~     happens in the brain when consciousness is lost and when it returns. During the study, a~     series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and~     electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal~     the neural correlates of consciousness. Consciousness of the subjects will be manipulated~     with normal sleep and anesthetic agents dexmedetomidine and propofol.~      First, various neurophysiological tools to separate consciousness, connectedness and~     responsiveness during normal sleep will be tested. The most suitable methods and subjects~     will be selected and then tested during anesthetic-induced sedation and loss of~     responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as~     target-controlled infusions (TCI) with step-wise concentration-increments until LOR is~     detected. Then, TCIs are repeated in the same subjects but adjusted according to the~     individual drug target concentrations sufficient for LOR, and a series of PET perfusion~     imaging measurements will be performed to obtain the brain activity information in various~     states of consciousness. The same subjects will then be imaged with PET for brain activity~     after sleep deprivation (awake), during various sleep stages and immediately after~     awakening. Finally, ten dexmedetomidine subjects will be given the drug once more, and~     functional MRI (fMRI) data will be collected at various states of consciousness before and~     during verbal and nonverbal vocalizations. EEG will be continuously collected in all~     sessions. The depth of anesthesia will be measured using quantitative EEG and bispectral~     index (BIS) monitoring.~      The results may lead to the discovery of new and better objective indicators of the depth of~     anesthesia and consciousness, and new insights into the understanding of neural mechanisms~     behind drug-induced loss of consciousness and ultimately the mechanisms of action of~     (general) anesthetics as well as consciousness itself.~   "
89256|NCT01888991|"~     The purpose of this study is to investigate the effect of substrate oxidation, expressed by~     RER, on food intake regulation and net energy balance.~   "
89257|NCT01888978|"~     This study is for patients with metastatic pancreatic cancer (cancer that has spread to~     other parts of the body). The purpose of this study is to determine whether molecularly~     tailored therapy can improve the effectiveness of standard chemotherapy combinations for~     patients with metastatic pancreatic cancer. A series of special tests will be performed on a~     sample of tumor, and based on the results subjects will be assigned to one of seven~     chemotherapy treatments, with each being the combination of two standard chemotherapies.~     Each of these combinations has been safely used in patients with pancreatic or other types~     of cancer. The purpose of this study is to to determine the ability to personalize therapy~     in this manner, and to determine how many patients a larger study would need. A second~     purpose is not to determine if one doublet is better than another. Rather, this second~     purpose is to show that for all patients enrolled in this protocol who have been assigned a~     doublet based on their tumor's molecular analysis (molecular tailoring), treatment response~     will be better than would be expected compared to patients who have been treated in the past~     with no molecular tailoring.~   "
89258|NCT01888965|"~     This study is for patients with stage 4 colon cancer who have had initial chemotherapy or~     had surgery to remove metastases and patients with pancreas cancer, which has been~     surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have~     already received chemotherapy and radiation.~      The purpose of this study is to determine the effects of oral dovitinib in patients with~     advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free~     survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to~     2 years.~   "
89259|NCT01888952|"~     This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in~     patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic~     leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple~     myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular~     lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior~     therapy and for whom no standard curative therapy exists. Patients with advanced stage~     disease are those whose disease is resistant or refractory to standard chemotherapy or~     biological therapies.~   "
89260|NCT01888939|"~     Background:~      - Some studies in adults have found that insulin and glucose blood levels are lower when a~     long period of sitting is broken up with walking, compared to sitting without breaks. This~     means that the body can better process sugars when there are walking breaks during the day.~     Researchers want to know if this is also true for children. Some studies have found that~     children s attention and memory might be better after exercise. Researchers want to know if~     short walking breaks have the same effects.~      Objectives:~      - To understand if breaking up sitting with walking helps children s bodies better use~     sugars and improves children s concentration.~      Eligibility:~      - Healthy children ages 7 to 11.~      Design:~        -  Participants will be screened with a physical exam, medical history, exercise test,~          picture vocabulary test, and medical tests including blood tests and X-rays.~        -  Participants will return for two 7-hour visits. In the month before the visits, they~          will wear a physical activity monitor for one week so researchers know how active they~          are. Once they will take the sitting only test and once the sitting breaks test.~        -  During the sitting only test, participants will sit for 3 hours.~        -  During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks~          every 30 minutes.~        -  Both days, they will drink sugar water. Then the participants will have blood drawn~          from a needle that is kept in place, and they will wear a heart monitor. They will take~          attention and working memory tests on a computer and answer questions about how they~          feel. They will eat a meal at the end of the test day.~   "
89276|NCT01888731|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
89277|NCT01888718|"~     To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30~     mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing~     fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S.~     LLC, Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To~     monitor adverse events and ensure the safety of subjects.~   "
89287|NCT01888588|"~     The analyses are conducted in a previous population-based cohort study using The Health~     Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses~     are:~      To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated~     with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in~     the general population To estimate the dose-response and duration-response associated with~     use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use~     of low dose ASA in the general population To evaluate the effect of proton pump inhibitors~     (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the~     general population To investigate the management of low dose ASA/oral antiplatelets after~     UPU~   "
89261|NCT01888926|"~     Background:~      - People with dystonia have serious muscle contractions that cause abnormal movements or~     postures. This significantly affects their daily lives. The common type is called organic.~     The other type is psychogenic. People with this type have typical symptoms plus some~     psychological effects. Researchers will look at how rapid transcranial magnetic stimulation~     (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect~     sensations. They will compare the responses of people with different types of dystonia. They~     will also compare the responses of people with dystonia to responses of people without it.~     This study may help us learn more about the nature of different types of dystonia.~      Objectives:~      - To see whether TMS combined with nerve stimulation affects the brain differently in people~     with different types of dystonia and those without dystonia.~      Eligibility:~        -  Individuals at least 18 years old, who are right-handed and have dystonia.~        -  Healthy volunteers at least 18 years old.~      Design:~        -  Participants will have two clinical visits. Each visit will be a few hours long. They~          can be done on the same day.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will take several sensory tests. For these tests, electrodes will be~          placed on their skin. The participants will feel small electric shocks during some of~          the tests.~        -  Participants will undergo TMS. For 2 minutes, quick electrical currents will pass~          through a wire coil placed on their head. As this happens, researchers will ask the~          participants to move certain muscles.~   "
89262|NCT01888913|"~     Background:~      - We are studying people s psychological experiences and how these relate to the way people~     respond have when they see information communicated in different ways. We are testing~     multiple research questions in this research.~      Objectives:~      - To learn about how to design future research studies. Also to learn about how to best give~     people information about health topics.~      Eligibility:~      - Women with a Body Mass Index of 25 or higher.~      Design:~        -  Before the study visit, participants will answer some questions online about~          themselves, their experiences, and their thoughts about their weight.~        -  During the study visit, participants will watch a short scene from a movie, and then~          answer questions about it.~        -  Participants will have a simulated doctor visit with a computerized, virtual reality~          doctor. They will answer more questions about themselves, their experiences, and their~          thoughts about their weight. Then they will answer questions with researchers.~   "
89263|NCT01888900|"~     Background:~      - Some people who have chronic hepatitis C do not respond to the usual treatment with~     peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may~     work better for different people. The treatments will look at how specific genes interact~     with the drugs. Researchers want to see how well these new drugs work in people whose~     chronic hepatitis C has not responded or only partly responded to the usual treatment drugs.~      Objectives:~      - To compare new treatments for people with chronic hepatitis C.~      Eligibility:~      - Individuals at least 18 years of age who have chronic hepatitis C that has not responded~     to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Liver scans and a biopsy will be taken before the start of~          treatment.~        -  Participants will be separated into two groups. One group will have the new treatment~          drugs (assunaprevir and daclatasvir). The second group will have these two drugs as~          well as peginterferon and ribavirin. All participants will have an initial 4-day~          hospital stay with regular blood tests to see how the start of the treatment works.~        -  The first group will take the new study drug tablets daily for 24 weeks. Those who do~          not respond to this treatment will also start to take peginterferon and ribavirin, and~          the treatment will continue for 24 weeks after starting the additional drugs.~        -  The second group will take all four drugs according to the standard dosing schedule for~          24 weeks.~        -  Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other~          tests will be performed as directed by the study doctors.~        -  Participants will have 24 weeks of regular followup visits.~   "
89264|NCT01888887|"~     Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin~   "
89265|NCT01888874|"~     -  595 patients suffering from active rheumatoid arthritis despite continued treatment~          with methotrexate will be evaluated for improvement of disease activity (efficacy) when~          taking GLPG0634 (3 different doses - 50mg, 100mg and 200mg daily -, each evaluated as~          QD and BID regimen) or matching placebo for 24 weeks.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur (safety and tolerability), and the amount of GLPG0634 present in the~          blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism~          of action-related parameters in the blood (Pharmacodynamics) will be determined. Also,~          the effects of different doses and dose regiments of GLPG0634 administration on~          subjects' disability, fatigue, and quality of life will be evaluated.~   "
89266|NCT01888861|"~     Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing~     serum and intracellular level of antioxidants and enzymes in critical ill patients, which~     result in increasing ventilator dependency and length of stay in intensive care unit and it~     also accelerate organ failures in patients. In this double blind clinical trial, the~     investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive~     care unit that the investigators expect to stay for more than 7 days in this ward and who~     have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After~     randomization of included patients by block randomization the investigators will give~     900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control~     group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency~     period, length of stay in ICU, mortality and decelerate of organ failures.~   "
89267|NCT01888848|"~     This study is being conducted to assess the effect of dietary blueberry supplementation on~     cognition and mobility in older adults. It is hypothesized that plant compounds, present in~     blueberries, may improve cognition and mobility by protecting against oxidative stress and~     inflammation.~   "
89268|NCT01888835|"~     The investigators recently conducted a double-blind, randomized controlled trial (n=60) of~     limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an~     FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine,~     as determined by reduction in meth-positive urines. Sexual risk behaviors also declined~     significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use~     despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily~     doses were taken. All participants received weekly substance use counseling and monthly,~     brief clinician-delivered adherence counseling. The investigators propose expanding upon~     these results by lengthening the treatment period to 24 weeks, with adherence reminders~     added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug~     discontinuation. The sample size for this 9-month study is 120.~   "
89269|NCT01888822|"~     The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in~     elective laparoscopic cholecystectomy.~   "
89278|NCT01888705|"~     Recently, there has been a growing interest in the study of nonlinear dynamics as a~     methodology for complementary analysis to characterize the respiratory pattern. These~     methods are well established in studies of heart rate. The analyzes evaluate complex~     signals, including large-scale fractal correlations and distributions in time series, and~     can provide relevant clinical information.~      Measures such as approximate entropy and sample entropy have shown great potential in the~     evaluation of the complexity of the respiratory system, providing information relevant to~     the understanding of physiological and pathophysiological processes. These measures are~     based on the concept of non-linearity in the presence of a high number of interconnections,~     resulting in the complex behavior exhibited by physiological systems.~      The approximate entropy (ApEn) is related to the amount of clutter, complexity or~     unpredictability of a data series over time. In a complementary way, the sample entropy~     (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to~     self-similarity.~      A study conducted by our group in asthma patients with different levels of bronchial~     obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in~     asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in~     asthma disorders that are associated with complex changes in the pathophysiology triggering~     breath control, possibly resulting in changes in air flow (V´).~      Considering the development silent changes of mechanical ventilation in COPD patients and~     its clinical relevance, as well as the difficulty of identifying such changes through~     conventional methods, we observed the need to obtain more detailed information, including~     the complexity of the system breathing for better understanding of factors that contribute~     to the illness.~      In this context, the objectives of this study were: (1) analyze the influence of airway~     obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate~     the diagnostic power of the test in identifying the changes caused by COPD.~   "
89279|NCT01888692|"~     Acknowledging that level I evidence already exists regarding the general beneficial impact~     on FDG PET in the staging and subsequent management of lung cancer the investigators~     postulate that fusing PET/CT data sets with RT CT simulation data sets for adult patients~     with conventionally/clinically assessed stage III non-small cell lung cancer will have a~     significant impact on GTV as well as normal tissue irradiation. This research will also~     estimate inter and intra-observer variability of treatment planning, relative to GTV,~     between and amongst radiation oncologists.~   "
89280|NCT01888679|"~     The purpose of this study is to evaluate and measure the movement of the endotracheal tube~     depending on the type and the amount of movement of the head of the patient intubated using~     a flexible fiberoptic.~   "
89281|NCT01888666|"~     The aim of this study is to evaluate the periodontal effects during rapid palatal expansion~     (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices,~     in order to establish the possible differences and advantages of one of these treatments in~     periodontal terms.~      Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10~     patients will selected and submitted to SPE treatment. The patients will treated with the~     Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI;~     papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during~     the treatment (before, during and at the end). All measurements will performed by the same~     examiner.~      A descriptive statistical analysis will conducted. The paired samples Student's T test will~     used to evaluate the intra-group differences between t1 and t2. The unpaired samples~     Student's T test will used to evaluate between groups differences at t1 and t2. The~     significance level will set at 95%.~   "
89282|NCT01888653|"~     Emerging research implicates biased attention to threat in the pathophysiology of anxiety~     disorders. Recent findings demonstrate significant associations between attention bias and~     stress vulnerability. This work has motivated the development of a novel therapy,~     attention-bias-modification treatment (ABMT). ABMT is designed to implicitly modify~     patients' biased threat attendance via computerized training protocols. Emerging evidence~     indicates that ABMT is effective in modifying threat-related attention biases and in~     ameliorating anxiety symptoms. However, it is unclear whether ABMT is efficacious for~     Posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that~     seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of~     ABMT in individuals with PTSD. In addition this pilot study seeks to identify specific genes~     associated with anxiety disorders and to examine whether these can predict the success of~     the ABMT.~   "
89283|NCT01888640|"~     Pain associated with fibromyalgia interferes with daily function, work, and social~     activities resulting in a decreased quality of life. People with fibromyalgia also have a~     significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced~     excitability of pain neurons in the central nervous system and reduced pain inhibition.~     Therefore, one of the main treatments for patients with fibromyalgia must focus on pain~     relief to allow the person to function more independently both at home and at work.~     Transcutaneous electrical nerve stimulation is used by health professionals to deliver~     electrical stimulation through the skin for pain control. Basic science studies, from the~     PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit~     excitability of pain neurons. Thus the ideal patient population for the treatment of TENS~     would be one in which there is enhanced central excitability and reduced inhibition;~     fibromyalgia is such a condition.~      Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical~     Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and~     movement-related pain and reduce central excitability by restoring diffuse noxious~     inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will~     reduce fatigue and fear of movement, thereby improving function and quality of life~   "
89284|NCT01888627|"~     The study examine the effectiveness of an integrated care program including therapeutic~     assertive community treatment (ACT) for people with psychotic disorders fulfilling severe~     and persistent mental illness (SPMI, ACCESS-II study).~   "
89285|NCT01888614|"~     The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta~     thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether~     etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it~     is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical~     care (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when~     sampled, total and direct bilirubin). We hope to establish whether this inexpensive and~     non-invasive test faithfully reflects hemolytic parameters in sickle cell syndromes.~   "
89286|NCT01888601|"~     To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and~     the dynamics of intratumour heterogeneity over time combined with detailed clinical,~     histopathological and cancer phenotypic annotation for each patient, in order to~     significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence~     and improve survival).~   "
89288|NCT01888575|"~     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained~     .The aims of the post hoc analyses are:~      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI~     concomitant use versus non-use, crude and adjusted by confounding.~      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI~     concomitant use stratified by age and sex.~      To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA~     therapy.~   "
89289|NCT01888562|"~     To test the patient's cancerous tumor to see if it has a FGFR mutation and, if so, to see~     how their cancer responds to a treatment with the drug ponatinib as well as examine the side~     effects caused by ponatinib.~   "
89290|NCT01888549|"~     Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux;~     double-blind, placebo-controlled, randomized clinical trial~   "
89291|NCT01888536|"~     This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin~     capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast~     tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal~     stenosis.~   "
89292|NCT01888523|"~     Determine the efficacy of a brief and inexpensive psychosocial intervention, (called~     expressive writing) in improving health outcomes for cancer survivors.~   "
89293|NCT01888510|"~     This clinical trial studies computed tomography (CT) in diagnosing patients with lung~     cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.~   "
89294|NCT01888497|"~     This study will examine the next-day residual effects of a nighttime dose of gabapentin 250~     mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on~     simulated driving performance in normal volunteer subjects. It will also examine other~     measures of next-day performance and next-day sleepiness.~   "
89295|NCT01888484|"~     This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a~     12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm~     in preventing serious bacterial infections (SBI) compared with historical control data and~     to evaluate the pharmacokinetic (PK) characteristics of octanorm.~   "
89296|NCT01888471|"~     Feasibility phase for a study to evaluate antibody levels against Group B Streptococcus in~     mothers and their infants at delivery to establish antibody levels associated with~     reductions in risk of GBS disease in infants aged less than 90 days.~   "
89297|NCT01888458|"~     Infections due to post transplant immune deficiency are a major problem following allogeneic~     stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood~     transplant (CB). Duration of neutropenia is one of the most important risk factor for~     invasive fungal infection (IFI). In this setting, Micafungin has been approved for~     antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind,~     comparative, phase III trial, the overall efficacy of micafungin was superior to that of~     fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However,~     very few patients in this study received a CB transplant.~      This is phase IIb, prospective, open-label, non-comparative study to assess the safety of~     micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB~     as source of stem cells.~   "
89298|NCT01888445|"~     This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in~     dialysis chronic kidney disease patients with anemia.~   "
89299|NCT01888432|"~     The purpose of this trial is to demonstrate the efficacy and safety of everolimus in~     combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver~     transplant recipients.~   "
89300|NCT01888419|"~     Background~      In Denmark, breast cancer is the most common fatal cancer in women with more than 4700 new~     cases annually. Unfortunately, up to 60% of women who are treated surgically for breast~     cancer, will experience chronic pain as a consequence of the treatment. This state of~     chronic neuropathic pain is termed Post Breast Therapy Pain Syndrome or PBTPS.~      The purpose of the study~      The purpose of this study is to investigate whether transplantation of fat cells~     (lipotransplantation) to the pain affected mastectomy area, could have an analgesic effect~     in women who have developed PBTPS. Secondary, we wish to investigate if lipotransplantation~     has a beneficial effect on the quality of the skin and the scar in the area where the~     transplanted fat cells are placed.~      Hypotheses~        -  Lipotransplantation to the area under the scar tissue and the area under the~          pain-afflicted area reduces the pain in women with PBTPS.~        -  The neuropathic pain in PBTPS is correlated to the number of free nerve endings~          crossing the border between the dermis and the epidermis~        -  Lipotransplantation have a beneficial effect on the scar tissue structure and improves~          the skin quality.~      Patients~      Women who have undergone treatment for breast cancer and subsequently developed PBTPS. A~     total of 32 patients with PBTPS will be included.~      Methods~      Patients will be randomly assigned to receive either lipotransplantation or no active~     treatment. At three follow-up visits, the perceived pain of the patient and the skin and~     scar quality will be scored. In addition, a 3-mm biopsy will be taken from the skin on both~     the missing and the healthy breast, and from the mastectomy scar.~      The scoring of the perceived pain and the quality of the skin and the scar, allows us to~     investigate if the lipotransplantation have an effect on pain, and skin/scar quality.~     Additionally, the skin and scar biopsies will be examined on a microscopic level, in order~     to investigate why lipotransplantation has these effects.~      Conclusion~      In summary, the results of this project could help to increase our understanding of why some~     patients develop chronic neuropathic pain after mastectomy and radiotherapy. It is our hope~     that our results may contribute to the development of better and more effective treatment~     that will be beneficial for the project participants and future patients.~   "
89301|NCT01888406|"~     BEST4US compares the effectiveness of two forms of self-help interventions that target~     college students, ages 18 years to 22 years, who report binge eating. The overall question~     is whether one or the other format will prevent excess weight gain and lead to differences~     in eating behaviors. The two formats are (1) pure self-help (receipt of a self-help~     program via book form or online texts) and (2) a combination of the self-help program and~     guidance provided by a trained peer coach over the course of 8 weekly sessions.~   "
89302|NCT01888393|"~     This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of~     lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.~   "
89319|NCT01888172|"~     The purpose of this study is to conduct a randomized controlled trial to compare the weight~     losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips~     ActiveLink physical activity system, over a 1-year period, compared to a control group.~   "
89320|NCT01888159|"~     Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation~     has an effect on ovarian reserve.~   "
89321|NCT01888146|"~     The overall aim of this study is to adopt an integrative rehabilitation approach for helping~     patients adopt self-management skills for managing chronic pain, limiting use of opioid~     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,~     sleep problems) that is feasible and sustainable within the primary care setting.~   "
89303|NCT01888380|"~     In light of declining autopsy rates around the world, post-mortem MR imaging is a promising~     alternative to conventional autopsy in the investigation of infant death. A major drawback~     of this non-invasive autopsy approach is the fact that histopathological and microbiological~     examination of the tissue is not possible. The objective of this prospective study is to~     compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy,~     with conventional autopsy procedures in a paediatric population.~      Foetuses, newborns, infants and children that are referred for autopsy at three different~     institutions associated with the University of Zurich will be eligible for recruitment. All~     bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators~     will be blinded to the results of conventional autopsy. After cross-sectional imaging,~     CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot)~     allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with~     regards to the likely final diagnosis and major pathological findings and compared to the~     results of conventional autopsy, which remains the diagnostic gold standard.~      This interdisciplinary study will determine whether virtual autopsy will narrow the gap in~     information between non-invasive and traditional autopsy procedures.~   "
89304|NCT01888367|"~     This is a randomized, blinded, placebo and standard of care controlled study of the efficacy~     of a novel antibiotic containing gel compared to placebo gel in preventing surgical site~     infection after abdominal surgery. patients will be randomized to active or placebo gel in a~     double-blind manner. The gel will be applied a single time in the incision during closure at~     the end of surgery. A cohort of patients will also be randomized to standard of care, saline~     irrigation at prior to skin closure, in an open manner. The efficacy, safety and~     tolerability of the active gel will be assessed compared to the control group (combined~     placebo gel and standard of care groups). Patients will be randomized to DFA-02 active gel:~     placebo gel: standard of care in a 4:1:1 ratio.~   "
89305|NCT01888354|"~     This pilot study is designed as a prospective cohort study to determine whether standard~     subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5~     days in the treatment of relapses or attacks in multiple sclerosis (MS).~   "
89306|NCT01888341|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal,~     non-smoking,healthy males under fasting conditions~   "
89307|NCT01888328|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal,~     non-smoking,healthy males under fed conditions~   "
89308|NCT01888315|"~     The study is aiming to document the long-term safety and effectiveness of renal denervation~     in patients with hypertension and other diseases characterized by elevated sympathetic~     drive. Catheter-based renal denervation will be performed using CE marked, percutaneous,~     systems.~   "
89309|NCT01888302|"~     This pilot phase I trial studies the side effects and best way to give sirolimus,~     gemcitabine hydrochloride, and cisplatin in treating patients at high risk for~     cholangiocarcinoma recurrence after liver transplant or surgery. Sirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride, and cisplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving sirolimus with gemcitabine hydrochloride and cisplatin may prevent disease~     recurrence in patients with a high risk of recurrence after a liver transplant or surgery.~   "
89310|NCT01888289|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal,~     non-smoking,healthy males under fasting conditions~   "
89311|NCT01888276|"~     The pathophysiology of compulsive disorders as gambling could be close to behavior problems~     encountered in Parkinson's disease associated with a hyperactivity of the motivational~     system.~      Thanks to the words generation test, which reflects the cortico-subcortical loop~     functioning, involved in motivation, we want to evaluate and compare using tools (words~     generation and behavioral tests) the motivational functioning of gamblers and healthy~     volunteers that we can then compare to that of Parkinson's patients with and without~     behavioral hyperdopaminergic disorders which were explored in another study.~   "
89312|NCT01888263|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
89313|NCT01888250|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
89314|NCT01888237|"~     The purpose of this study is to compare the efficacy between 1-day high dose PPI-based~     triple therapy vs. 10-day sequential therapy for Helicobacter pylori eradication in~     functional dyspepsia patients.~   "
89315|NCT01888224|"~     To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin~     Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing~     Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal,~     adult, human male subjects under fed condition.~   "
89316|NCT01888211|"~     The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain~     uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid~     supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and~     monocyte activation in patients with coronary heart disease.~   "
89317|NCT01888198|"~     The purpose of this study is to better understand how effective ablation is for destroying~     tumor cells in the kidney and whether quality of life is improved for patients.~     Participation in ARMOR may involve retrospective data collection only, combined~     retrospective and prospective data collection, or prospective data collection~   "
89318|NCT01888185|"~     This study is designed to determine if magnetic resonance imaging (MRI) measures can be used~     to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing~     between PD and parkinsonisms [conditions that are PD look-a-like diseases such as~     progressive supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with~     changes in certain proteins in body fluids that are related to iron (Fe).~   "
89322|NCT01888133|"~     Can participation in group physical activity, such as a community-based organized group~     walk, help adult diabetes patients develop a physically active lifestyle? Can such~     engagement ultimately lead to an improvement in hemoglobin A1c? To address this question,~     the investigators have designed this pilot study with the aim to investigate the effect of~     community-based group walks among Joslin adults with diabetes on the development of a~     physically active lifestyle and glycemic level. The investigators hypothesize that~     participation in group walking events helps Joslin adults with diabetes engage in physical~     activity and improves glycemic control.~   "
89323|NCT01888120|"~     The objectives of this study are to evaluate the effectiveness, long-term safety,~     tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)~     associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.~   "
89324|NCT01888107|"~     The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety~     of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed~     psychiatric disorder relating to a complex psychotic state that has features of both~     schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving~     treatment with any antipsychotic medication and who required a long-term antipsychotic~     therapy. The secondary aim is to investigate prospectively (a study that starts with the~     present condition of a population of individuals and follows them into the future) the~     prevalence of patients who met standardized remission criteria (according to Andreasen et~     al. criteria) and the psychopathological, psychosocial and subjective predictors of~     achieving remission.~   "
89325|NCT01888094|"~     Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the~     subclavian venous and examination guided with ultrasound~   "
89326|NCT01888081|"~     The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing~     irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable~     with median overall survival periods that range from 8-16 months.~   "
89327|NCT01888068|"~     A new investigational device (BIA/Vitality Analyzer™) is being compared to a United States~     Food and Drug Approved 'predicate' reference device (EFG®) to demonstrate that they provide~     equivalent measurements of body fat. Both devices are over-the-counter bioimpedance body~     composition analyzers (estimate of body fat). These devices are classified as 'Not~     Significant Risk' devices; they do not expose you to any significant risks.~   "
89328|NCT01888055|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an~     increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).~   "
89329|NCT01888042|"~     It is a an open label, multicentric, phase II study assessing the efficacy of everolimus~     (given per os) as a first line treatment in kidney cancer of bad prognosis.~      92 patients will be included (anticipated). The treatment by everolimus will continue until~     progression, significant toxicity or withdraw of consent~   "
89330|NCT01888029|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive~     impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked~     potentials (MEP) in mV).~   "
89331|NCT01888016|"~     The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to~     reduce pain and improve physical functionality after rotator's cuff surgery. The technique~     involves deep friction manipulation of fascia's specific spots. Distant from surgical site.~   "
89332|NCT01888003|"~     The goal of this study is to gain further insight into the comparative effectiveness of~     treating patients, who are found to be anemic before their elective surgery, with a series~     of weekly subcutaneous doses of a drug given before surgery, which stimulates the natural~     production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along~     with intravenous iron, in reducing the need for blood transfusions (donated by someone other~     than the patient) during and after adult total hip arthroplasty (hip replacement surgery).~     The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of~     recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery~     will also be examined. A cost-effectiveness analysis will be performed to compare the cost~     of these commercially available, FDA-approved medications versus the cost of transfused~     blood~   "
89333|NCT01887990|"~     This study is dedicated to achieving better treatments for suicidal thoughts. Specifically,~     the investigators are studying the effect of a medication called ketamine to quickly treat~     suicidal thoughts and depression.~   "
89334|NCT01887977|"~     A computational model of human sound production based on high quality anatomic measurements~     and physical laws of sound propagation cannot be accomplished without a comprehensive data~     set including both 3D-images of the speaker's anatomy and the simultaneous recording of~     speech. Since the computational model has separate models for the vocal folds and the vocal~     tract, patients undergoing an orthognathic surgery is an optimal test object for the model~     development. Vocal folds remain unchanged while substantial changes take place in the vocal~     tract. Moreover, since the aim of the research is to predict acoustic changes in speech due~     to operations in head neck area, the orthognathic patient group is par excellence an example~     of such a prediction problem. If the model can be shown to give valuable information~     pre-operationally, many other patient groups could benefit from the results.~   "
89335|NCT01887964|"~     Metabolic syndrome is a condition characterized by excess body weight, large waist~     circumference, high cholesterol and glucose in the blood, and hypertension. People with~     metabolic syndrome are at increased risk for heart diseases. Research shows benefits of~     regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the~     high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients.~     This study is designed to find if blinded-substitution of regular wheat flour in domestic~     kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4),~     minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from~     wheat.~   "
89336|NCT01887951|"~     Introduction~      Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of~     analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties~     administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It~     is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a~     potential agent for early administration of analgesia by Singapore Civil Defense Force~     (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on~     its use as an analgesic agent in general are limited and there are few published controlled~     trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common~     medication used in the hospital setting for analgesia. It is well proven, simple to deliver~     and is not a controlled drug.~      Aim~      To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by~     the SCDF EAS.~      Methodology~      The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol).~     Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility~     criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances),~     will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The~     other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be~     on a per station level. After 6 months, they will cross over to Penthrox and tramadol~     respectively.~      All paramedics will be trained to use both medications, pain scales and Ramsey scores, and~     will record patient's pain, sedation scores and patient satisfaction as part of routine~     clinical practice. All patients will be followed up by a review of their Emergency~     Department and hospital records for any medication related adverse effects.~      Hypothesis~      The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting~     to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by~     inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue~     Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.~   "
89337|NCT01887938|"~     The purpose of this study is to collect long-term safety data in patients with metachromatic~     leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070~     through Week 40.~   "
89338|NCT01887925|"~     The purpose of this study is the evaluation of effect of circadian gene on sleep and other~     symptoms in breast cancer patients under chemotherapy.~   "
89339|NCT01887912|"~     The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile~     (Cdiffense) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects~     a risk for CDI where there is a substantial unmet medical need.~      Primary objective:~        -  To assess the efficacy of the C. difficile vaccine in preventing the onset of~          symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult subjects~          aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.~      Secondary Objectives:~      Efficacy:~        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections~          administered at 0, 7, and 30 days~        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of~          at least 2 injections.~      Immunogenicity:~        -  To describe the immunogenicity to toxin A and toxin B in the subset of subjects at~          specific time points.~      Safety:~        -  To describe the safety profile of all subjects who receive at least 1 injection.~   "
89340|NCT01887899|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in patients with dementia of the~     Alzheimer type (DAT) leads to an increase in cortical plasticity (change in motor evoked~     potentials (MEP) in mV).~   "
89341|NCT01887886|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     safety and efficacy of onartuzumab in combination with erlotinib in patients with previously~     untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and~     activating EGFR mutation and MET-positive. Patients will be randomized to receive either~     onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally~     daily or placebo in combination with erlotinib. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
89342|NCT01887873|"~     The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients~     with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating~     deep sclerectomy procedure.~      In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of~     cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open~     angle glaucoma and clinically significant cataract. Given that a considerable number of~     glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer~     i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also~     of importance because a combined procedure avoids the need of a second operation in this~     group of patients. Finally, it has been shown that combined phacoemulsification - deep~     sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I~     study).~      Safety will be assessed based on the occurrence of adverse events.~      Efficacy assessments will be performed at every visit and efficacy analysis will include:~        -  Proportion of subjects at each study time point which will need additional IOP lowering~          drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more~          than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP~          reduction will be recorded.~        -  Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture~          to achieve an IOP reduction to values < 21 mmHg.~   "
89343|NCT01887860|"~     Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or~     irritant in certain individuals.~   "
89344|NCT01887847|"~     The objective of this study is to compare the pharmacokinetics of an investigational 2 mg~     sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine~     lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise~     healthy smokers.~   "
89345|NCT01887834|"~     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable~     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring~     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is~     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and~     bloating.~      The medicines that are currently used to help people with IBS are not as effective as we~     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS~     and not actually treat the disorder itself. Recently, scientists have found that probiotics~     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and~     diarrhea that are part of IBS.~      This research is being conducted to determine whether this particular combination of three~     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium~     longum) will reduce the symptoms of severe IBS.~   "
89355|NCT01887704|"~     The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective,~     randomized controlled trial was perform to explore the immediate effect and long-term~     outcome of rotational atherectomy in patients with balloon resistant coronary lesion.~   "
89346|NCT01887821|"~     This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the~     two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for~     treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for~     many years they become less effective at treating a disease, especially when they are not~     used at adequate doses according to national guidelines or when counterfeit drugs are~     available in the market. The purpose of this study is to check that Chloroquine and~     Artemisinin, are still effective for patients in Viet Nam.~      Participants in this study will be treated with either Dihydroartemisinin-Piperaquine~     (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national~     guidelines to treat vivax malaria. The investigators would like to know if both of these~     treatments are equally effective so half of the patients in the study will be treated with~     DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare~     the drugs to find out if one is better than the other.~      Participants will be followed for 3 days in hospital, then regularly by follow-up visits~     until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites~     in the participant's body and how the blood cells react to the malaria. The parasite will be~     tested to determine what type it is and how it reacts to the treatment.~      The results of the study will be used to inform malaria treatment guidelines in Viet Nam.~   "
89347|NCT01887808|"~     Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact~     sensitizer or irritant in certain individuals~   "
89348|NCT01887795|"~     1. Verify the effect of Erlotinib concurrent whole-brain radiation therapy as ﬁrst-line~          treatment for patients with multiple brain metastases from non-small-cell lung cancer~          to compare with WBRT alone.~        2. Verify pre-built EGFR mutation prediction model for NSCLC brain metastases~   "
89349|NCT01887782|"~     This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the~     standard conventional high frequency left sided stimulation protocol. The Left dorsolateral~     prefrontal cortex will be the site of stimulation in both treatment conditions. The site of~     stimulation will be targeted using MRI co-registration. The study seeks to determine if the~     two treatment protocols have similar effectiveness in treating major depression.~   "
89350|NCT01887769|"~     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung~     cancer is the leading cancer-related death worldwide and it represents a pressing health~     issue. Patients with lung cancer are more likely to experience cachexia, a severe~     debilitating disorder causing fatigue, weight loss, muscle wasting and associated with~     reduced physical function, increased chemotherapy toxicity and reduced survival. This~     syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in~     about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been~     mainly studied from several assessment methods which do not usually differentiate muscle~     from other tissues.~      Aim: To analyze body composition of patients with lung cancer at diagnosis using computed~     tomography (CT-Scan) image analysis.~      Methods: This is a retrospective study extending over a period of 3 years conducted at the~     Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed~     patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in~     our institution. Following the collection of clinical data from patient records, we used~     SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area~     from a single abdominal cross-sectional image at the level of the third lumbar vertebra.~   "
89351|NCT01887756|"~     Telerehabilitation refers to the use of Information and Communication Technologies (ICT) to~     provide rehabilitation services to people remotely in their homes or other environments. By~     using ICT, patient access to care can be improved and the reach of clinicians can extend~     beyond the physical walls of a traditional healthcare facility, thus expanding continuity of~     care to persons with disabling conditions. The concept of telecare, when telerehabilitation~     is used to deliver services to patients in their homes or other living environments,~     empowers and enables individuals to take control of the management of their medical needs~     and interventions by enabling personalized care, choice and personal control Research Goal~     and Objectives~        1. To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab~          system in post-stroke patients, in their homes.~        2. To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's~          home in terms of:~             1. function of the weak upper extremity~             2. performance of ADL~   "
89352|NCT01887743|"~     The World Health Organization has declared childhood obesity to be one of the most serious~     public health challenges of the 21st century,~     (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally~     excluded from clinical trials, little to no information exists regarding the impact of~     obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how~     to appropriately select the dose of many critical medications (e.g., anticancer agents), so~     as to prevent toxicity associated with overdosing, while avoiding the harms of~     under-treatment. The proposed study will examine the effect of obesity on the metabolism of~     a commonly used medication, the proton pump inhibitor pantoprazole, by exploring the~     relationships between age, obesity, basal metabolic rate and genetic control of the enzyme~     primarily responsible for pantoprazole metabolism. We will also validate a simple breath~     test that can be used to predict pantoprazole dose requirement for obese children.~      The study is designed to test the following experimental hypotheses:[13C]-pantoprazole~     pharmacokinetic parameters are not different between non-obese and obese children and~     adolescents, collectively (both age groups combined) or stratified by age group (SA 1)~     [13C]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are~     not different between males and females (SA 1 & 2) [13C]-pantoprazole pharmacokinetic~     parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent~     of age over the age range of 6 to 17 years (SA 1 & 2) Obesity does not alter the relative~     contributions of CYP2C19-dependent and non-CYP2C19-dependent (i.e., CYP3A4) metabolism of~     pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole~     sulfone (SA 1 & 2) The [13C]-pantoprazole breath test, by determining DOB at discrete time~     point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance of pantoprazole~     (surrogate for CYP2C19 activity) is a function of REE in obese and non-obese children and~     adolescents (SA 3) Pantoprazole clearance (surrogate for CYP2C19 activity) is associated~     with fat distribution, as determined by waist-to-hip ratios (SA 3)~   "
89353|NCT01887730|"~     In this study the investigators aim to elucidate the possibility to reduce occurrence of~     infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators~     will study occurrence and transmission of infections. In addition, the investigators will~     find out the causative agents of infections in a garrison with virological analyses of~     naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due~     to infectious diseases will be evaluated with a cost analysis study.~   "
89354|NCT01887717|"~     This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled~     clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of~     care therapy (sorafenib) in the treatment of patients with inoperable liver cancer and~     blockage of the portal vein.~   "
89356|NCT01887691|"~     The purpose of this study is to examine the influence of sleep effectiveness on glucose and~     insulin metabolism in health and disease (prediabetes and type two diabetes).~      We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal~     blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement~     [using eszopiclon (Lunesta), a medication that promotes stable sleep)] on glucose and~     insulin homeostasis.~      We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity,~     relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone~     (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to~     baseline.~   "
89357|NCT01887678|"~     The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® /~     Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated~     with osteoarthritis of the knee.~   "
89358|NCT01887665|"~     The clinical trial portion of this study tests the hypothesis that contingency~     management-based incentives for primary care patients with substance use disorders to attend~     treatment services will increase treatment initiation and engagement. The investigators are~     investigating whether this approach that has been found effective in specialty treatment~     settings will work in the primary care context, in conjunction with screening.~   "
89359|NCT01887652|"~     The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to~     identify women at risk of excessive and poor response in controlled ovarian stimulation~     (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized~     COS strategies in these subsets of patients.~   "
89360|NCT01887639|"~     A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain~     local data about the prevalence of non remitted depressed patients after an antidepressant~     treatment, and to get information about sociodemographic and clinical characteristics of~     these patients as well as features of their treatments and compare them with those of the~     patients that achieve remission. Also the effect of patient´s expectation in the treatment~     outcome will be examined.~   "
89361|NCT01887626|"~     Study to investigate if the uptake of Ticagrelor into the body differs depending on method~     of administration.~   "
89362|NCT01887613|"~     This study is to investigate the long-term safety and efficacy and the information on the~     proper use of Regnite® under conditions of daily clinical use.~   "
89363|NCT01887600|"~     This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a~     reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport~     of oxygen in your blood. The purpose of the study is to see if Roxadustat is both effective~     and safe as a treatment for anemia in patients with chronic kidney disease.~   "
89364|NCT01887587|"~     This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus~     MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma,~     lymphoblastic lymphoma or mixed phenotype acute leukemia.~   "
89365|NCT01887574|"~     Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and~     harness the latest technology to organize and analyze data.~   "
89366|NCT01887561|"~     The purpose of this study is to assess whether dasatinib can be discontinued without~     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase~     in complete molecular remission(CMR) while on dasatinib.~   "
89367|NCT01887548|"~     Quality of life is recommended as one of essential parameters to evaluate treatment effect~     and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that~     several disease-unrelated variables may affect quality of life in CD patients. This study is~     dedicated to investigate the influence of various personality traits on quality of life, and~     whether or not they should be taken into account when evaluating clinical outcomes in~     patients with CD.~   "
89368|NCT01887535|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of multiple-ascending dose JNJ-54861911 which is currently being developed~     for the treatment of Alzheimer's disease.~   "
89369|NCT01887522|"~     Multicenter, open label, prospective study including successively a phase I trial and then a~     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both~     drugs, vinblastine and nilotinib.~   "
89370|NCT01887509|"~     This innovative study will involve the use of probe-based confocal laser endomicroscopy, a~     new medical imaging technology never used for surgical indications to date. Virtual biopsies~     (pCLE images) will be compared to histopathology analysis.~      This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE~     will allow identification of rectal tumor margin, comparable to that of histopathology. In~     the future, decision of resection margin could rely on intraoperative pCLE exam.~      The proposed study is a feasibility study, first in the indication of rectal cancer.~   "
89371|NCT01887496|"~     Epidemiological information on varicella complications in children is essential for the~     development of appropriate immunization recommendations. Economic analyses of varicella~     immunization are sensitive to the costs of hospitalized cases, so there is a need to~     validate varicella-related hospitalization data in a country-specific manner. These data~     also provide a baseline for comparison with data collected after routine varicella~     immunization to evaluate the overall impact and cost-effectiveness of varicella immunization~     programs. Knowledge about the cause and incidence of varicella-related hospitalizations in~     Turkey is limited, center-specific and not sufficiently accurate. The aim of this~     multicenter study (VARICOMP) was to estimate the annual incidence of pediatric~     varicella-related hospitalization, describe the associated complications and estimate the~     annual mortality and economic cost of these cases.~   "
89372|NCT01887483|"~     A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus~     on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).~   "
89373|NCT01887470|"~     The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a~     preparation for colonoscopy.~   "
89374|NCT01887457|"~     This is a trial to determine whether giving a patient a tailored dose of voriconazole is~     safe and effective.~   "
89572|NCT01884883|"~     The aim of this study is to confirm the biomechanical effects and evaluate functional~     benefits of a new knee brace combining valgus inducing effect on medial compartment and leg~     external rotation during the stance phase in patients with symptomatic medial knee~     osteoarthritis.~   "
89375|NCT01887444|"~     The purpose of this study is to evaluate the efficacy of the oral administration of~     Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty~     breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to~     receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time~     >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups.~     The average daily crying time as well as the associated digestive symptoms will also be~     analyzed.~   "
89376|NCT01887431|"~     The purpose of this study is to determine whether Telecare can be used for efficient~     management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent~     clinic visits.~   "
89377|NCT01887418|"~     Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.~   "
89378|NCT01887405|"~     The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for~     the proportion of subjects with a successful self-injection. And to evaluate and compare the~     handling characteristics of two auto-injectors (Jext and EpiPen).~   "
89379|NCT01887392|"~     The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice~     guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the~     gap between knowledge generated from research and practice. The investigators' primary~     objective is to evaluate if this intervention can increase the percent of long-term care~     (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is~     considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis~     or a fragility fracture of the hip or vertebrae and those who have had more than one~     fragility fracture and is therefore considered high-risk). A secondary objective is to~     examine whether the intervention increases the percent of all LTC residents receiving~     Vitamin D equivalent to ≥800 IU/day.~   "
89380|NCT01887379|"~     Furosemide is a diuretic drug, used in the treatment of oedematous states associated with~     cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to~     thiazide diuretics. Furosemide is also used in the treatment of hypertension.~      Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is~     60-70%, but variable and not predictable, with large intra- and inter-individual~     variability, and are influenced by dosage form, underlying diseases, and by the presence of~     food after oral administration. Data from animal model show that furosemide administered~     into the stomach is more rapidly absorbed than if is administered into the small intestine.~      To increase the residency of furosemide in the stomach after oral administration, a~     gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study,~     the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects.~     Absorption will be characterised by an effective and safe imaging technique - Magnetic~     Marker Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic~     signal that can be used for up to 12 h after furosemide administration to localize the~     medication in the gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in~     medicinal products. It does not exhibit own pharmacodynamic activity and is considered as an~     inactive ingredient.~      In the current study, GRDF formulation of furosemide will be evaluated for: gastric~     residence as well as pharmacokinetic and pharmacodynamic characteristics under fasting and~     fed conditions. As part of the study, the subjects will be hospitalized for 1 day during~     each drug administration. The duration of the stay will depend on the intestinal behaviour~     of the investigational product.~   "
89381|NCT01887366|"~     The primary objective of this study is to assess the efficacy and safety of TV-1380~     [Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)] in~     facilitating abstinence in cocaine-dependent subjects.~   "
89382|NCT01887353|"~     The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of~     recurrent atrial fibrillation in post-cardioversion patients with heart failure and~     preserved ejection fraction.~   "
89383|NCT01887340|"~     The purpose of the study is to evaluate the ration of patients getting an lighten~     therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM)~     in grade I (cohort 1) or metastatic (cohort 2) seminoma~   "
89384|NCT01887327|"~     Neonatal jaundice is the most common cause of hospital readmission for term- and near term~     infants and its management poses a significant burden on the healthcare system.~      Infants with isoimmune hemolytic disease, such as ABO or Rhesus (Rh) incompatibility, or~     glucose-6-phosphate dehydrogenase (G6PD deficiency), have an increased rate of red cell~     destruction and, thus, an increase in bilirubin production. Newborn infants have immature~     liver function and do not conjugate bilirubin well, which results in accumulation of~     unconjugated bilirubin. Thus, bilirubin levels may rise rapidly and intervention may be~     required. At present, phototherapy (PT) is the most frequently used treatment for~     hyperbilirubinemia; it converts unconjugated bilirubin to less toxic water soluble~     photoisomers that are then excreted in the urine without need for conjugation. Infants who~     do not respond to PT are treated by exchange transfusion (ET), considered a therapy of last~     resort because of associated morbidity and mortality. Both PT and ET enhance the elimination~     of, but have no impact on the production of bilirubin.~      Stannsoporfin is a heme oxygenase inhibitor that acts to reduce bilirubin production. It is~     being developed for the management of neonatal jaundice.~   "
89385|NCT01887314|"~     The purpose of the study is verify the capability of a standardized Ginger (Zingiber~     officinale) extract to manage nausea in cancer patients receiving highly emetogenic~     treatments and standard anti-emetogenic therapy.~   "
89386|NCT01887301|"~     A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug),~     safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol~     [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver)~     function impairment.~   "
89387|NCT01887288|"~     To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine~     with oral digoxin in metastatic breast cancer~   "
89388|NCT01887275|"~     The purpose of this study is to investigate the efficacy and safety of medical ozone in~     treatment of chronic hepatitis B patients.~   "
89389|NCT01887262|"~     Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better~     protection of residual renal function over 1 year period, compared with management guided by~     clinical information alone - such as blood pressure, body weight, and physician's physical~     examination.~   "
89390|NCT01887249|"~     10-day sequential therapy was not sufficient to overcome tough situation for H. pylori~     eradication in Korea due to high antimicrobial resistance. The present investigators assumed~     that doubling duration of second phase of sequential therapy might have more potent~     bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with~     initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with~     metronidazole was not ever tested before. Moreover, whether extending the sequential therapy~     to 15-day might be more effective than 10-day sequential therapy is unknown especially in~     Korea. From this background, the present investigators prepared clinical trials regarding~     modified sequential therapy which was extending the treatment duration to 15 days compared~     than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial~     susceptibility testing was performed to find the possibility to overcome antimicrobial~     resistance.~   "
89391|NCT01887236|"~     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of~     this study is to explore the effect of two types of physical activity on stability~     parameters.~   "
89392|NCT01887223|"~     When the glaucoma filtering surgery failures (intraocular pressure rises again), the options~     is start to use the hypotensive eye drops again (medical treatment). However, in some cases~     (encapsulated blebs), there is a simple surgical revision that can revival the primary~     failure surgery. It calls transconjunctival needling revision. In this study, the~     investigators compare the efficacy of this revision versus medical treatment in 12-month~     follow up in eyes with encapsulated blebs.~   "
89393|NCT01887210|"~     This study will develop and test a novel, technology based intervention to improve treatment~     adherence among youth living with HIV who are taking antiretroviral medication. In the~     intervention youth will access an engaging and immersive app/game on their smartphone.Data~     about the opening of the smart pill bottle will be transferred from the bottle cap~     wirelessly and will trigger a text message about their adherence. While gaming, participants~     will gain information about their health, improve motivation for ARV and medical appointment~     adherence, and practice healthy behaviors. If the Intervention is found to be effective, it~     can be tested in a larger study and then disseminated to other youth on antiretroviral~     medications.~   "
89394|NCT01887197|"~     The investigators are developing a new nuclear medicine imaging technique for measuring~     liquid absorption in the airways that can be applied to screen new medications being~     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of~     the small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid~     (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether~     new CF medications will be effective. In this study the investigators will determine whether~     the imaging technique will demonstrate similar results when it is repeated on different~     days. They will also determine how their results change when subjects utilize several common~     CF medications.~   "
89395|NCT01887184|"~     Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may~     be associated with discomfort. Although upper endoscopy is usually of shorter duration and~     better tolerated by patients, most trials investigating the influence of analgesia and~     sedation have been performed on patients undergoing this procedure. Some patients may~     tolerate colonoscopy without sedation, but various techniques are used to limit discomfort~     and pain. Selection and dosing of sedatives depends on the patient's emotional state, the~     intensity of pain during examination, foreseeable technical difficulties, the endoscopist's~     experience, the presence or absence of anesthesia personnel, and hospital-specific~     procedures.~      Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal~     endoscopy. The combination of an opioid and a benzodiazepine is known to provide good~     analgesic and sedative conditions during endoscopy. This combination of opioid and~     benzodiazepine, however, also increases the risk of respiratory depression. Therefore,~     pharmacologic agents which may provide adequate sedation without respiratory depression are~     of great interest to clinicians.~      Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic~     effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as~     a full agonist in most pharmacologic test models. Potentially desirable properties include~     decreased requirements for other anesthetics and analgesics, a diminished sympathetic~     response to stress and the potential for cardioprotective effects against myocardial~     ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its~     lack of respiration depression is a distinct advantage. Previous studies using~     dexmedetomidine for sedation has been promising with maintenance of respiratory function.~     Patients are readily arousable. With intravenous slow bolus administration, there is a~     minimal increase in blood pressure initially, followed by a slight decrease in blood~     pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of~     administration tend to decrease these circulatory side effects. Many clinical studies have~     shown that it can be well and safely used intravenously, intramuscularly and transdermally.~     Although not an officially technique, there are also reports of intranasal administration~     resulting in fairly predictable onset in both adults and children.~   "
89396|NCT01887171|"~     The purpose of this study is to determine whether the Tacrolimus added to~     histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and~     intraarterial infusion during back-table procedure is capable of reducing the degree of~     early allograft liver dysfunction, as assessed by postoperative levels of aspartate~     aminotransferase (AST), alanine aminotransferase (ALT), during first 7 postoperative days~     and by serum and histochemical markers of liver injury and inflammation.~   "
89397|NCT01887158|"~     Studies that have investigated different bowel preparations in patients with history of~     colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation~     in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are~     the most popular and safest bowel preparation regimens, however the 4-Liter volume is often~     poorly tolerated. More recently, it has been shown that the use of a low volume preparation~     (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel~     cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare~     the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.~   "
89406|NCT01887041|"~     To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs.~     endoscopical stenting for palliation of biliary obstruction due to locally unresectable or~     metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on~     older studies, but with new chemotherapeutic regimens available, the likelihood to~     experience stent complications has increased. Therefore, the issue as to which palliation~     should be favoured has to be reconsidered.~   "
89407|NCT01887028|"~     Use lay language.~      The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12~     mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression~     in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low~     Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum~     may be better in minimizing adverse effects on surgical peritoneal environment and improving~     clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard~     cool, dry CO2 gas.~   "
89398|NCT01887145|"~     No randomized trials have compared long-term outcomes following endoscopic and open carpal~     tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a~     single-center randomized controlled trial between January 1998 and December 2002, including~     128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed~     idiopathic CTS. The outcome measures included the validated CTS symptom severity and~     functional status scales completed at baseline and 1 year postoperatively. The trial showed~     that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and~     function were equivalent. This extended follow-up of the randomized trial will primarily~     measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by~     mail to the patients. The questionnaire will consist of the CTS symptom severity and~     functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of~     the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog~     scale about treatment satisfaction. The patients will also be asked about whether they had~     undergone further surgery for CTS in the same or contralateral hand after their operation in~     the randomized trial. The completed questionnaires will be scanned into a database. The~     scores for the different scales will be calculated. Analysis will include comparison between~     the open and endoscopic groups as well as within-group changes of scores from 1 year to~     10-15 years.~   "
89399|NCT01887132|"~     Background:~      - Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some~     of these children spend very little time in the rapid eye movement (REM) stage of sleep.~     Some studies suggest that less time in REM sleep can be associated with learning and~     behavior problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil~     can increase REM sleep in some adults with different disorders. A small study showed that~     Donepezil can also increase REM sleep in children with ASD. Researchers now want to see if~     Donepezil can improve communication skills and social interaction in children with ASD. They~     also want to see if any change in symptoms seems to come from changes in REM sleep.~      Objectives:~      - To see if a medication, Donepezil, can improve the way communication skills and social~     interaction develop in young children with autism spectrum disorders.~      Eligibility:~      - Children 22 to 44 months of age with ASD.~      Design:~        -  Participants will be screened with a blood test, heart tests, and a sleep study. During~          the sleep study, children will sleep in a darkened room for 2 nights with electrodes on~          their body and a tube under their nose. Parents can sleep in the room with their child.~          A technician will monitor the room all night.~        -  Participants will take the study medication once a day.~        -  Treatment will be monitored at visits every 3 months. At each visit the participant~          will take blood tests, heart tests, or behavior tests. Participants will have 2 more~          sleep studies.~        -  Participation will end after 18 months.~   "
89400|NCT01887119|"~     The prevalence of obesity and obesity-related complications is currently taking epidemic~     proportions. These complications increase the risk of type 2 diabetes and cardiovascular~     disease, which are important causes of morbidity and mortality worldwide.~      It is important to gain insight in the mechanisms underlying obesity-related complications,~     because this may lead to the development of directed therapeutic strategies.~      Currently, there is significant evidence that the cause of both insulin resistance and~     hypertension must be sought at the level of the microcirculation.~      Over activity of the renin-angiotensin-aldosterone system is a potential cause of~     microvascular dysfunction. Angiotensin II was indeed found to be implicated in the~     pathogenesis of obesity-associated hypertension and insulin resistance, possibly through~     interference with the vascular effects of insulin.~      Increased aldosterone levels have also been associated with resistant hypertension and~     insulin resistance, which is illustrated in patients with primary aldosteronism.~     Furthermore, aldosterone is known to exert several detrimental effects on the vasculature,~     some of which are offset by mineralocorticoid receptor antagonists.~      In obese individuals, plasma aldosterone concentrations are increased as well. We~     hypothesize that increased aldosterone levels in adipose persons induce microvascular~     dysfunction, which contributes to the development of insulin resistance and hypertension,~     and mineralocorticoid receptor antagonism results in improved insulin sensitivity and~     decreased blood pressure by counteracting the adverse effects of aldosterone on the~     microvasculature.~   "
89401|NCT01887106|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to~     healthy male subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as~     well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be~     characterized compared to placebo.~      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with~     GLPG1205 will be explored.~   "
89402|NCT01887093|"~     It has been well known that moderate and regular levels of physical activity has a favorable~     effect on many of the established risk factors related to coronary artery disease (CAD).~     Given that exercise in the morning has a greater potential for inducing sudden cardiac death~     and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at~     this time. Our previous study indicated that the protective effect of exercise in the~     evening was greater than morning. However, which times of day to exercise could achieve the~     greatest improvements in lipids and inflammatory markers remains unclear. The purpose of the~     present study was to investigate the responses of lipid profiles and inflammatory markers to~     walking at different times of day in sedentary patients with CAD.~   "
89403|NCT01887080|"~     The aim of this study was to investigate the effects of electric stimulation~     (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with~     acute myocardial infarction~   "
89404|NCT01887067|"~     To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension~     and its effect on glucose metabolism in patients with type 2 diabetes mellitus~   "
89405|NCT01887054|"~     This study is designed to evaluate whether a specific visuospatial training task will change~     gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of~     gait.~   "
89573|NCT01884870|"~     Ureteral stones may be silent in 5.3% of patients. The goal of this study was to~     prospectively evaluate the impact of a silent ureteral stone on renal function.~   "
89410|NCT01886989|"~     This study aims to investigate the postprandial effects of cocoa supplementation in glucose~     and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The~     investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal~     breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in~     patients with diabetes. Randomized cross-over controlled trial, in which participants will~     be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2~     diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups~     cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive~     high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI)~     measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day~     for 2 days.~   "
89411|NCT01886976|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
89412|NCT01886963|"~     The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell~     Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound~     complications after complex ventral hernia repairs. Complex ventral hernia repairs are~     associated with a high rate of wound complications. To a large degree these complications~     are caused by creating tissue advancement flaps to close the abdomen, which can compromise~     the blood supply to the skin and subcutaneous tissues. The current standard of care for~     assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however,~     often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite~     System is a device that enables surgeons to visualize and evaluate tissue perfusion in real~     time. It can help the surgeon to identify optimal flap design and reduce the risk of~     postoperative wound complications related to tissue ischemia. The primary goal of this study~     is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps~     with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite~     System has been used successfully for assessing the viability of mastectomy flaps in breast~     surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis.~     However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy~     Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral~     hernia repairs.~   "
89413|NCT01886950|"~     A study of the natural history of bone and mineral disease (BMD) in patients with end-stage~     renal disease before and after kidney transplantation~   "
89414|NCT01886937|"~     The goal of this study is to determine whether one week of phentermine compared to placebo~     administration results in changes in food intake during a laboratory meal.~   "
89415|NCT01886924|"~     The long-term goal of this program of research is to disseminate an effective, brief~     computer-based intervention that can be readily integrated into HIV treatment settings to~     motivate tobacco quitline use among smokers living with HIV. The overall objective of this~     application is to develop this computer intervention, modify it based on initial piloting~     and feedback, and obtain preliminary data supporting the efficacy of the intervention. This~     will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary~     pilot testing (n=16) of a brief, computer-based intervention intended to motivate tobacco~     quitline use among cigarette smokers living with HIV (Computer Intervention to Motivate~     Engagement in Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a~     computer-based, time matched nutrition education for PLWH control intervention (NC) equated~     for the offer of a tobacco quitline referral and 8 weeks of free nicotine patch for those~     who engage in quitline treatment, 2) to conduct a preliminary smoking cessation, randomized~     controlled trial (RCT) with 100 people living with HIV (PLWH) who smoke cigarettes,~     comparing CI-METQ vs. NC, with predictions that CI-METQ relative to NC will result in~     increased readiness, higher rates of tobacco treatment engagement, more quit smoking~     attempts and higher rates of 7-day point prevalence abstinence rates at 1-, 3- and 6-month~     follow-ups. Health-related quality of life over this period will also be examined, and 3) to~     examine CI-METQ's effects on key mechanisms during the computer session and their~     associations with tobacco treatment engagement and smoking outcomes at 1- and 3-month~     follow-ups.~   "
89416|NCT01886911|"~     This project is focused on the neural and behavioral correlates of two different videos~     games that will be used as training tools. The two video games, developed by the Games~     Learning Society research group at the University of Wisconsin-Madison (UW) and the~     Wisconsin Institute for Discovery, are tailored to train mindfulness, particularly the~     regulation of attention; and prosocial behavior, especially sensitivity to others, in~     adolescents. This study will evaluate the hypothesis that systematic playing of mindfulness~     and prosocial games will change brain function in specific attentional, social and emotional~     circuits in potentially beneficial ways, and will impact performance on cognitive tasks of~     attention, and on measures of social cue perception and the propensity to share and behave~     altruistically. The investigators will employ behavioral and functional MRI-based~     neuroimaging measures to evaluate the investigators hypothesis.~   "
89417|NCT01886898|"~     The primary objective of the trial is to assess the growth of the infants enrolled into the~     study. Other parameters to be measured include microbiota balance and certain blood~     biochemical values. In addition the infants' digestive tolerance of the formulae and~     frequency of morbidity will be investigated.~   "
89418|NCT01886885|"~     The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic~     Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and~     increase pain acceptance in participants with chronic pain. The secondary objective is to~     explore if MBCPM will reduce depression and increase quality of life and mindfulness in the~     same group of participants. The additional aim of the pilot study is to evaluate the~     feasibility of conducting the MBCPM intervention in participants with chronic pain. We~     hypothesize that participants with chronic pain will show relatively good compliance with~     completing the MBCPM protocol and will show increased satisfaction associated with~     improvement in pain-related and other psychosocial indicators of functioning.~   "
89419|NCT01886872|"~     This randomized phase III trial studies rituximab with bendamustine hydrochloride or~     ibrutinib to see how well they work compared to ibrutinib alone in treating older patients~     with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as~     rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used~     in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether rituximab with~     bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone~     in treating chronic lymphocytic leukemia.~   "
89420|NCT01886859|"~     This phase I trial studies the side effects and best dose of lenalidomide when given~     together with ibrutinib in treating patients with chronic lymphocytic leukemia or small~     lymphocytic lymphoma that has returned after a period of improvement or does not respond to~     treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together~     with ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocytic~     lymphoma.~   "
89421|NCT01886846|"~     We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin~     levels in acute and convalescent periods of the acute rheumatic fever and by comparing~     results with that of healthy control group; also by comparatively examining levels of~     adiponectin in ARF cases who had different clinical findings at presentation. In addition,~     we aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with~     cytokines such as TNF-α, IL-6 and IL-8 and acute phase reactants.~   "
89422|NCT01886833|"~     Zambia recently introduced routine infant immunization against rotavirus - the most~     important cause of severe gastroenteritis and diarrhoea mortality in children. Although~     vaccines like Rotarix are a cost effective tool against infectious diseases, live oral~     vaccines can be less immunogenic and efficacious in developing world settings as compared~     with industrialized countries. Reasons behind this phenomenon are not well understood, but~     may relate to continued maternal antigen exposure and high level maternal immunity that is~     passed to the foetus/newborn transplacentally and/or through breast milk.~      Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal~     immunity (in the form of anti-rotavirus breast-milk IgA and transplacental serum IgG) is a~     major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition~     negatively impacts infant immunity and increases the risk of post-vaccination rotavirus~     gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular~     epidemiology of circulating rotavirus strains detected in vaccinated children presenting~     with severe diarrhea.~      To address these hypotheses, the proposed study will recruit a prospective cohort of 420~     mother-infant pairs. These will be enrolled at the time of vaccination and followed for up~     to four years. Baseline immunological status will be ascertained and seroconversion rates~     determined a month after full immunization. Incident rotavirus gastroenteritis will be~     monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this~     surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four~     year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc~     deficiency, weight for age Z-scores as well as mid upper arm circumference will also be~     assessed. Knowledge gained from this study will inform future interventional trials on~     strategies to improve rotavirus vaccine effectiveness in the developing world.~   "
89423|NCT01886820|"~     To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral~     β-Amyloid When Compared With Postmortem Histopathology~   "
89424|NCT01886807|"~     Patient demographics (age, height and weight) will be collected for 546 consecutive patients~     presenting for dental restoration under general anesthesia. The baseline saturation will be~     recorded. The induction of anesthesia will be standardized for all patients. All patients~     will undergo an inhalational induction administered by face mask. After inserting an~     intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl~     could be added at the discretion of the anesthesiologist. The patients will be mask~     ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes~     after the administration of rocuronium.~      Patients will be randomly assigned to one of three groups for the purpose of airway~     management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation~     (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation~     (DLO2 Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL~     Group). Computer-generated treatment allocations (using the PLAN procedure in SAS~     statistical software, using random-sized blocks) will be maintained in sequentially numbered~     sealed envelopes that will be opened after consent is obtained. The laryngoscopy and~     intubations will be performed by the study investigators who are faculty anesthesiologists~     or by the mid-level or resident or fellow working with them.~      The study will be stopped when:~        -  the patient will be intubated and a CO2 trace is obtained on the capnography or~        -  if the patient desaturates to 90%~        -  or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or~          hypotension)~      Randomized groups will be compared for balance on potentially confounding baseline variables~     using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will~     be characterized using both time to 1% saturation drop from the baseline and the rate~     (slope) of desaturation after an initial 1% drop. We will consider a given intubation~     technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e.,~     not worse) on both outcomes and superior on at least one of the outcomes. Thus our primary~     hypothesis will be assessed in a joint hypothesis testing framework described by Mascha and~     Turan. We a-priori define the non-inferiority delta for the outcome time to 1% drop as 5~     seconds (or 1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.~   "
89425|NCT01886794|"~     Our primary aim in the current study is to determine important tissue differences, including~     muscle and connective tissue changes, between postmenopausal women and reproductive age~     women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.~   "
89426|NCT01886781|"~     In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy~     and will the probiotic influence gut microflora and thus improve clinical outcomes, as~     compared to no intervention.~   "
89427|NCT01886768|"~     Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with~     conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective~     and time-efficient. The investigators and in other studies have showed that nasal~     pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of~     patient tolerance and visual capacity. Although pledgetting method to a selected meatus can~     achieve better decongestion effect, epistaxis and nasal pain in some patients are still~     frustrating to endoscopists.~      The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability~     by anterior rhinoscopy using a transnasal endoscope. The investigator also suggest~     endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing~     trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal~     endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at~     least the posterior end of a turbinate. We hypothesize that by using endoscopic-guided~     method, gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus~     (MNM) simultaneously is more tolerable than only gauze pledgetting to a single meatus.~   "
89428|NCT01886755|"~     An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of~     symptoms in infants and young children with acute gastroenteritis.~   "
89429|NCT01886742|"~     The population continues to increase in weight. Currently there are no guidelines in the~     dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for~     patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical~     prophylaxis. This makes no provisions for weight based dosing. There has been some recent~     data which states this might not be enough for the obese patients. The primary objective of~     this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical~     prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric~     bypass provides appropriate serum concentrations for a larger percentage of time than the~     current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The~     concentration of cefazolin in tissue will also be measured to help assess this question.~   "
89430|NCT01886729|"~     The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric~     oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to~     the protocol. The purpose is to determine the effect of the time shift of tDCS. Two~     conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS~     3 weeks after the start of the tinnitus.~      An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks~     and 12 weeks.~   "
89431|NCT01886716|"~     The purpose of this research is to test a computerized intervention for people with~     co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce~     symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues.~     The investigators expect that participants receiving alcohol or anxiety training will~     experience reductions in those specific symptoms compared to participants in a control~     condition. The investigators also expect that participants receiving combined alcohol and~     anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative~     to participants in any other condition.~   "
89432|NCT01886703|"~     This pilot study will assess whether a supported pedometer-based walking program is helpful~     in maintaining physical activity for breast and head-and-neck cancer patients who are~     undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help~     provide support for physical activity during radiation therapy. We will also examine the~     relationship of physical activity and quality of life outcomes to help inform future~     research.~   "
89433|NCT01886690|"~     This study will compare the safety and efficacy of a new eye drop formulation with REFRESH~     PLUS® in participants following LASIK surgery.~   "
89434|NCT01886677|"~     RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and~     energy balance may play a major role in prostate cancer progression.~      PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy~     energy-restricted diet and exercise, in slowing or preventing disease progression in~     patients who have newly diagnosed prostate cancer.~   "
89435|NCT01886664|"~     The investigators tried to evaluate the effect of desflurane on the incidence of~     postreperfusion syndrome during living donor liver transplantation surgery. The~     investigators used sevoflurane as a comparison.~   "
89436|NCT01886651|"~     The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT)~     activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment~     interruptions during maintenance therapy for children with ALL.~      Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity~     polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM)~     compared to children with normal TPMT activity.~   "
89437|NCT01886638|"~     HIV positive patients have a two fold increased risk of developing cardiovascular disease~     (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to~     both HIV and the side effects from anti-HIV medications.~      Abacavir (an important component of current HIV treatment regimens) is one medication shown~     to be associated with an increase the risk of heart attacks in some studies. The mechanism~     by which abacavir does this is unknown.~      We hypothesise that abacavir is leading to heart disease by interacting with platelets,~     which then form blood clots within the arteries supplying the heart, the subsequent blockage~     of the artery causing a heart attack.~      This study aims to determine if abacavir increases the activity (or stickiness) of~     platelets, and thus provide evidence as to how it may be promoting heart attacks.~      It will consist of 23 HIV positive men who currently have well controlled HIV. Participants~     will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood~     sample to assess platelet activity will be taken at baseline, following the 15 days of~     therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout~     period (to determine if any effects are reversible).~   "
89438|NCT01886625|"~     Background of the study: CRPS type-1 is a pain syndrome that usually develops after an~     initiating noxious event (e.g. fracture) in an extremity. Although treatment options life~     dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical therapy exist, the~     treatment effect is often unsatisfactory, even leading to amputation of the extremity.~     Surgical treatment of chronic pain disorders by dividing the sympathetic chain is an~     established treatment. Its more invasive nature has prevented widespread application. After~     introduction of minimal invasive techniques in recent years, the UMCG has now devised a~     truly minimal invasive, yet safe and effective thoracoscopic technique, that requires only a~     single 1 cm long incision in the anterior axillary line. This technique is developed as~     treatment for primary focal axillary and palmar hyperhidrosis, and is performed in over 50~     patients producing very satisfying results. This fact has led to the hypothesis that this~     same surgical technique can offer this group of chronic pain patients a safe, effective~     treatment modality.~      Objective of the study: The effect of the intervention on pain an regain of function in de~     affected extremity. This will be quantified in multiple questionnaires at baseline and three~     follow-up points, and by clinical evaluation of the hand function at baseline and two~     follow-up points.~      Study design: Single center prospective feasibility study~   "
89574|NCT01884857|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
89575|NCT01884844|"~     The purpose of this study is to whether vitamin d supplementation in those with low levels~     may reduce depression symptoms in people experiencing bipolar depression.~   "
89439|NCT01886612|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES)~     have been shown to improve lower limb blood flow. However, few studies have directly~     compared the two methods and those that have, have used dated NMES techniques.~      The objective of this study is to compare the two methods in terms of blood flow.~   "
89440|NCT01886599|"~     The purpose of the study is to determine how Asunaprevir is handled by the body of subjects~     with kidney disease compared with subjects with normal kidney function~   "
89441|NCT01886586|"~     This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive~     impairment (MCI) as an intervention for preventing major depression (DEP). PST will be~     modified so as to be provided to both MCI probands as well as their support person. The~     primary aim is to examine the effectiveness of PST in individuals with MCI and the support~     person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of~     exercise on preventing depression.~   "
89442|NCT01886573|"~     This pilot clinical trials studies azacitidine and entinostat in treating patients with~     newly diagnosed stage IA-IIIIA non-small cell lung undergoing surgery. Drugs used in~     chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Entinostat may stop the~     growth of cancer tumor cells by blocking some of the enzymes needed for cell growth. Giving~     azacitidine with entinostat may be an effective treatment for non-small cell lung cancer.~   "
89443|NCT01886560|"~     To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal~     burn.~   "
89444|NCT01886547|"~     We aim to determine the effectiveness of 2013 Mag paDRE ka programme in increasing general~     public awareness on prostate health and promoting prostate health assessment among Filipino~     males aged 40 or older.~   "
89445|NCT01886534|"~     Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at~     hospital discharge which may impact their ability to make effective decisions about their~     healthcare. However, informal care partners (CPs) may assist in managing HF when provided~     with appropriate education and support. The goal of this randomized clinical trial (RCT) is~     to evaluate an intervention which will provide 1) additional teaching on management of HF to~     the patient and CP following hospital discharge, 2) improved communication with the family~     physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital~     talking scale. The investigators believe this intervention will improve outcomes and be cost~     saving.~      The investigators hypothesize that enhanced education and support for the CPs to assist~     older HF patients following hospital discharge, combined with improved communication with~     family physicians, contact with a HF nurse, and simple decision support tools, will lead to~     earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and~     cost-effective approaches to manage HF patients following hospital discharge are urgently~     needed in Canada.~   "
89446|NCT01886521|"~     Recently, a clinical trial showed that the use of lumbar drains compared to ventricular~     drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic~     neurological deficits but failed to show a clinical benefit after 6 months. The underlying~     assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher~     concentration of blood than CSF from lumbar drains. The investigators decided to test this~     assumption. In this study, the investigators will randomize patients to either placement of~     a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.~   "
89447|NCT01886508|"~     The investigators designed this multicentre randomized study to investigate the clinical~     benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage~     Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to~     either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are~     urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace,~     cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients~     (120 per treatment arm) are planned to accrue for this study within 7 years.~   "
89448|NCT01886495|"~     The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory~     factors among overweight and obese children.~   "
89449|NCT01886482|"~     The investigators aimed to determine the effects of HP diet on CVD risk factors among~     overweight and obese children.~   "
89450|NCT01886469|"~     The main purpose of this study is to determine the rate and extent of absorption of one or~     more modified release formulations of amphetamine (HLD100) in both adolescents and children~     with ADHD.~   "
89451|NCT01886456|"~     To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective~     laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients~     suffering from open-angle glaucoma or ocular hypertension.~      Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well~     as 2, 3, 6, 9, 12, 18 and 24 months after treatment.~        -  Trial with medical device~   "
89452|NCT01886443|"~     The purpose of this study is to establish the safety of the combined drug approach~     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,~     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce~     ischemia-reperfusion injury during liver transplantation in eligible recipients.~   "
89453|NCT01886430|"~     The purpose of this study is to verify the effects of low frequency functional electrical~     stimulation in heart failure patients hospitalized for treatment of the syndrome.~   "
89576|NCT01884831|"~     In Russia the treatment nonhealing skin defects often limited to surgical interventions,~     despite having developed modern methods of treatment of non-healing ulcers and other skin~     imperfections. During the many years of research we have developed a skin equivalent~     comprising living cells.~      During pilot trial showed that the skin equivalent provides healing skin defect within 1-4~     weeks in 95% of patients.~   "
89454|NCT01886417|"~     Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant~     external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring~     would cause the verbal thoughts of the patient to be perceived as external voices resulting~     in AVHs.~      In order to examine whether AVHs correspond to self-generated inner speech, the present~     study aims at collecting speech muscle activity during covert AVHs (without articulation),~     overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and~     control subjects to detect any speech muscle activity during AVH.~   "
89455|NCT01886404|"~     The primary purpose of this study is to investigate the steady-state pharmacokinetics of~     efavirenz in older HIV-infected patients as compared to historical controls; to investigate~     the relationship of drug exposure to neuropsychiatric side effects and neuropsychological~     performance; and to explore the role of host polymorphisms in drug metabolism in the older~     patient.~   "
89456|NCT01886391|"~     The purpose of this study is to provide information on how the practicing of deep~     breathing(DBR - diaphragmatic breathing re-training)may improve the health outcomes and~     likelihood of heart failure patients to engage in health-promoting activities by~     successfully controlling their shortness of breath (dyspnea).~   "
89457|NCT01886378|"~     UX007-CL201 is an open-label Phase 2 study to assess the safety and clinical effects of~     UX007 in subjects with LC-FAOD. Following a 4 week run in period on current therapy,~     subjects will cross over to daily UX007 treatment for an initial 24 week treatment period,~     followed by an additional 54 week extension period. Approximately 30 subjects at least 6~     months of age inclusive with severe LC-FAOD, specifically VLCAD, LCHAD, CPT 2, or TFP~     disorders, will be enrolled and treated with UX007.~   "
89458|NCT01886365|"~     The debate about tight glycemic control (TGC) in the operating room and on the intensive~     care unit is ongoing, especially in cardio-surgical patients treated with blood~     cardioplegia, due to high blood glucose levels during operations and subsequent high rates~     of sternal wound infections. We showed in a feasibility study that early computer based~     insulin therapy starting in the operating room is a safe therapy that allows to better~     warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood~     cardioplegia.~   "
89459|NCT01886352|"~     In this study, we will compare 3 treatments. The first group of patients will receive the~     standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of~     the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of~     patients will receive the standard of care, with infiltration of the portal sites with the~     local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic (~     0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the~     beginning and the end of the surgery . The third group of patients will receive the standard~     of care, with infiltration of the portal sites with the local anesthetic ( 0.5%~     levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will~     use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the~     beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray~     device, an inexpensive delivery system that will direct a fine mist of drug directly to the~     areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms,~     peritoneal abdominal surface, surgical dissection site).~      Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine~     in reducing postoperative pain and of opioid requirements in patients undergoing~     gynecological laparoscopic procedures in one-day surgery.~   "
89460|NCT01886339|"~     SNIF test has been described as a method to explore the diaphragmatic function. But there~     are no defined the reference values of this test in healthy population. The investigators'~     hypothesis is that there is a variation on SNIF values in Mediterranean population depending~     on gender, age and anthropometric variables such as height and weight.~      The investigators will analyze 1000 SNIF test of healthy people. The investigators will~     divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the~     investigators will study 100 men and 100 women.~      All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and~     SNIF. If spirometry and MIP are correct the investigators will consider that person has a~     correct diaphragmatic function and strength. Then the investigators will measure the SNIF~     test. With all of these SNIF values the investigators will try to achieve the reference~     values of this test in the different groups of age in Mediterranean population. And the~     investigators will compare SNIF with MIP.~      Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar,~     Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital~     de la Vall d'Hebrón.~   "
89461|NCT01886326|"~     Evidence is accumulating that peanut consumption confers health benefits, such as reduction~     of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et~     al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight~     gain are widespread. Although research indicates that other characteristics of peanuts~     offset these properties, and that peanuts may be incorporated into diets without posing a~     threat to weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare~     providers, and consumers. Furthermore, worry exists that eating salted peanuts may elevate~     blood pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears~     create substantial obstacles to increased peanut consumption.~      Recommendations to increase peanut consumption may be made, but if they are not followed,~     there will be no impact on health. Additional knowledge is needed on: (1) the acceptability~     of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts~     and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The~     proposed research will examine the acceptability of long-term inclusion of a single form~     versus varied forms of peanuts in the diet. It is expected that responses will be varied~     among individuals with different personality characteristics (e.g., prefer sweet versus~     savory foods, hedonic versus non-hedonic eaters). A better understanding of how different~     segments of the population choose to include peanuts in their diet and how to optimize~     long-term consumption should provide insights for better marketing and improved health.~     Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and~     that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add~     credibility to the evidence that peanuts do not cause weight gain, as well as reinforce~     recommendations to increase peanut consumption for their health benefits.~   "
89495|NCT01885884|"~     This is a pilot, randomized controlled trial of an embedded collaborative model of~     supportive care designed to improve quality of life and decrease use of unwanted healthcare~     services at the end of life for patients with advanced pancreatic cancer. We will enroll 30~     patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed,~     locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying~     caregivers and providers. Patients will be randomized to receive either the supportive care~     intervention or usual care. The purpose of this study is to refine an embedded collaborative~     model of supportive care and to develop protocols for recruitment, randomization, and~     longitudinal data collection.~   "
89462|NCT01886313|"~     Herpes zoster (commonly referred to as shingles) results from the reactivation of the~     varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus~     lays dormant in the cells of the nerves until activated. Once activated, patients develop a~     characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic~     neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals,~     is the most common and most feared complication of herpes zoster infection. The drug,~     Civamide is thought to desensitize the nerves and decrease the pain of PHN. This is the~     pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal~     nerve, a nerve that is in the nose and transmits pain from the face. The objective of this~     study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%)~     for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of~     the trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.~   "
89463|NCT01886300|"~     This prospective, multicenter, observational study will evaluate the sustained response in~     patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to~     standard of care and in line with the current local labeling in routine clinical practice in~     Vietnam. Eligible patients will be followed for the duration of their treatment and for up~     to 2 years thereafter.~   "
89464|NCT01886287|"~     The primary purpose of the study is to investigate the effects of high-dose octreotide on~     flushing, diarrhea, and quality of life in patients whose disease-related symptoms are~     inadequately controlled by the maximum approved dose of octreotide LAR.~   "
89465|NCT01886274|"~     Migraine has been described as one of the most common neurological diseases, with high~     social and economic impact. Despite the high prevalence, the pathophysiology of migraine is~     still unknown, several studies have been developed in order to advance the understanding of~     the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The~     aim of this study is to observe the effects of transcranial direct current stimulation~     (tDCS), applied in the visual cortex, on neurophysiological and clinical measures~     (frequency, intensity, duration of attacks and severity of pain) in migraine patients.~   "
89466|NCT01886261|"~     Usability of the PALMS system, validity of the PALMS system and added value to an existing~     cohort study.~      Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better~     examine place-based interventions.~   "
89467|NCT01886248|"~     To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive~     diseases following hematopoietic stem cell transplantation.~   "
89468|NCT01886235|"~     This pilot clinical trial studies intravital microscopy for identifying tumor vessels in~     patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures,~     such as intravital microscopy, may determine the extent of melanoma.~   "
89469|NCT01886222|"~     This study is a prospective multi-centre randomized trial to compare the effect of long-term~     mild hypothermia versus routine normothermic intensive management in patients with severe~     traumatic brain injury.~      The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for~     5 days will improve the outcome of patients at six months post injury compared with~     normothermia.~   "
89470|NCT01886209|"~     This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of~     corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the~     PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of~     VX-509 when coadministered with each of these corticosteroids.~   "
89471|NCT01886196|"~     Inflammation increases with aging and is implicated in the reduction of bone mass, muscle~     mass, and strength. Resistance training is safe and effective for increasing muscle mass and~     strength in older adults,however resistance training by itself cannot suppress inflammation.~     Ibuprofen is a non-steroidal anti-inflammatory drug that may provide benefits to muscle mass~     and strength when given after resistance training sessions in older adults; however, more~     evidence is required to confirm effects across the lifespan. The objectives are to determine~     the effect of 9 months of exercise training and ibuprofen supplementation, compared to~     placebo, in older women (≥65years)on the following dependent variables:~        -  bone density, geometry, and architecture~        -  muscle mass and strength~        -  balance~   "
89472|NCT01886183|"~     The objective of this work will be compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke~     patients. It is a prospective, single blinded, randomized clinical trial performed at Center~     of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of~     São Paulo University. Forty patients will be randomly assigned in control and experimental~     group, 20 each one.~   "
89473|NCT01886170|"~     In this two-phase mixed methods study, the investigators will first use patient feedback~     from semi-structured interviews to explore the ways in which patients with diabetes~     understand their diabetes and assess their disease control. The investigators will also use~     these interviews to elicit patient feedback on promising alternative communication formats~     to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test~     new formats to communicate information regarding diabetes control to patients with poorly~     controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C~     (standard medical information) versus two alternative formats on several participant~     outcomes, primarily glycemic control at 6 months post-intervention.~   "
89474|NCT01886157|"~     Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is~     superior to corticosteroid treatment alone.~   "
89475|NCT01886144|"~     Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness~     that commonly alter the way one will climb stairs and walk reducing an individual's function~     and the activities they may perform on a day-to-day basis. Providing a person with a knee~     brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain~     and lead to improved function. The purpose of this study is to determine if use of the Rebel~     Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve~     strength and balance, and enhance functional activities such as stair and level gait, and~     ultimately lead to increased participation in the community.~   "
89496|NCT01885871|"~     The purpose of this study is to determine whether picosecond laser is effective in the~     treatment of age (sun) spots.~   "
89477|NCT01886118|"~     One of the main factors in the success of in-vitro fertilization is the quality of the~     environment of the embryo. In contrast to maternal age, the environment in which the embryo~     develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting~     culture media have been attempted in order to reproduce as much as possible the natural,~     physiological environment of the mother for the embryo in in-vitro fertilization. However,~     the different new culture media used are devoid of growth factors normally secreted by~     uterine cells that enhance the interaction between the embryo and its environment.~      Because the endometrial lining of the uterus secretes many different cytokines necessary for~     growth of the embryo, a new procedure has been developed to mimic the natural environment of~     the growing embryo using autologous (patient's own) endometrial cells in co-culture with the~     embryo. Endocell, a product developed by Genévrier Laboratories, received commercial~     authorization in France in 2011. It is the only system of autologous embryo-endometrium~     co-culture available on the actual market. The process consists of developing the embryo on~     a monolayer of the patient's own endometrial cells in order to favor its growth until the~     blastocyst stage (day 5) and to improve its implantation.~   "
89478|NCT01886105|"~     The primary goal of this study will be to examine tumor response after radiation treatment~     via a combination of Samarium-153 EDTMP and external beam radiotherapy.~   "
89479|NCT01886092|"~     Efficacy of different protocols of transcranial magnetic stimulation for the treatment of~     tinnitus~   "
89480|NCT01886079|"~     The purpose of study is to compare the incidence of acute kidney injury in patients~     receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.~   "
89481|NCT01886066|"~     The standard of care for women with high risk endometrial cancer is the removal of all~     visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to~     these areas. It is estimated that no more than 25% of all women with presumed early stage~     high risk endometrial cancer will have positive lymph nodes however currently the majority~     of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph~     nodes and its associated morbidities. The objective of this study is to determine if~     intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional~     lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial~     cancer. This would benefit the majority of women with early stage high risk endometrial~     cancer and would prevent the associated complications of pelvic lymph node dissection.~   "
89482|NCT01886053|"~     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in~     community-acquired pneumonia (CAP) subjects，and explore its therapeutic dose.~   "
89483|NCT01886040|"~     Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has~     been overcome the epithelial ovarian cancer because of the change of life style to western~     style recently. Most patients with endometrial cancer are stage I & II, the most histology~     is still endometrioid adenocarcinoma (type I endometrial cancer). In statistics, advanced~     stage (FIGO stage III and IV) is approximately 16% of all cases.~      Most patients has good outcome of endometrial cancer because their surgical stage is~     belonged to early stage. However, the recurrence, distant metastases and mortality are~     high if the diseases is confirmed to be advanced stage. The adjuvant therapies after~     staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/~     brachytherapy. Whether the adjuvant therapy can cure the disease of not is still~     controversial.~      Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic~     modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of~     chemotherapy and radiation therapy or sequential sandwich therapy were ever used for such~     group patients in each medical center. But the case number is insufficient and limited to~     show the survival or progression free benefit during the statistics. Besides, the surgical~     procedures and adjuvant therapy for early endometrial cancer is still remained to be~     determined. The investigators are also interested to analyze the factors affecting their~     survival.~      The investigators will perform a retrospective study to review the data of patients with~     endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial~     Hospital.~   "
89484|NCT01886027|"~     The primary goal of this study is to test the efficacy of emotional awareness and expression~     training (EAET), a novel emotional processing intervention that the investigators have~     developed, for people with IBS. In this randomized, controlled trial, the investigators will~     compare EAET to a standard intervention that teaches the conceptually opposite~     approach—relaxation training (RT)—and test how both of these interventions compare to a~     wait-list control condition. The investigators hypothesize that individuals in the EAET~     group will demonstrate greater improvement in their IBS symptom severity, psychological~     functioning, quality of life, and health care utilization at 4 and 12-week follow-up time~     points, compared to individuals in the wait-list control group. It is also expected that~     both of the active interventions (EAET and RT) will be more efficacious than the wait-list~     control condition.~   "
89485|NCT01886014|"~     Placebo responses contribute to medical treatment outcome. The purpose of this study is to~     determine whether a single intranasal application of oxytocin can increase the placebo~     response in an experimental model of placebo analgesia in healthy volunteers.~   "
89486|NCT01886001|"~     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care~     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can~     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).~     This study is a prospective, randomized controlled feasibility trial to evaluate three types~     of hygiene products on umbilical line stumps, on the effect of line colonization and~     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be~     randomized into one of four study groups, three products against standard of care (no~     product). The three products that will be evaluated are currently being used in different~     capacities for skin care in the UVA NICU. The study hypothesizes that daily topical~     application of 1 or more antiseptic to the top of the umbilical stump will decrease~     colonization of the umbilical stump while umbilical lines are in place.~   "
89497|NCT01885858|"~     This study is designed as a crossover randomized controlled trial, to investigate the~     effects of client's ethnic characteristics on the quality of family planning services.~   "
89487|NCT01885988|"~     The study will take part at The Men's Health Center It will involve men who have a diagnosis~     of erectile dysfunction and also have high blood pressure.~      High blood pressure can affect the lining of the arteries and cause stiffness in the~     arteries. The arteries and veins throughout the body have a lining called the endothelium~     which gives them the ability to stretch. If the lining of the penile arteries becomes~     impaired, it can decrease the stretching of the artery and decrease blood flow. Decreased~     blood flow in the penile arteries can cause problems obtaining an erection.~      The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the~     lining of the arteries, thereby improving stretch and blood flow.~      The primary objective is to determine if treatment with nebivolol improves endothelial~     function and erectile function in men with pre-hypertension and stage 1 hypertension~      70 men will be enrolled into the study. Half of the subjects will receive active medication~     and half will receive a placebo. All men will receive educational informational handouts~     about blood pressure and behavior modifications to improve blood pressure. The study will~     last for 3 months for each subject. The expected recruitment time is one year, with a 2 year~     study completion goal. Subjects will have approximately 5 study visits.~      Subjects will have initial/final blood work, a Rigiscan test (a take home penile erection~     test), two EndoPat tests to assess endothelium function, 3 SphygmoCor tests to assess~     central blood pressure, 2 sexual health questionnaires at 2 visits. Vital signs will be~     monitored at each visit to assess safety and effectiveness of the study medication.~   "
89488|NCT01885975|"~     The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will~     manifest a personality profile that differs than that of a population of similar range of~     ethnic and socioeconomic status.~   "
89489|NCT01885962|"~     The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health~     Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to~     prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This~     protocol is Phase 2 of a three phase project. In Phase 1, the investigators developed~     iSHIFTup. In Phase 2, the investigators will test the intervention by partnering with~     Woodrow Wilson Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT)~     of 18 participants. In Phase 3, the investigators will focus on optimizing the intervention~     based on our outcome findings and feedback, sustaining the program at WWRC, and seeking~     future funding for a larger RCT.~      The investigators will conduct an RCT of up to 18 participants (9 participants in treatment~     as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants~     are needed to obtain statistically significant results).~      The investigators will meet with potential participants in-person to complete the informed~     consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the~     program during the study period. Participants randomized to TAU will have usual treatment~     during the study period and an opportunity to use the program following trial participation.~     The investigators will collect information from participants at two times during the study,~     at enrollment and post-intervention at 6-weeks (42 days). The investigators will also~     collect qualitative information from participants in the TAU+iSHIFTup group, during an~     optional focus-group setting, to learn users' experiences with the program. The~     investigators expect participants in the TAU+iSHIFTup group as compared to the TAU group, to~     display greater awareness of personal risk for pressure ulcers; increased preventive~     behaviors; and increased skin care self-efficacy and knowledge.~   "
89490|NCT01885949|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational combination of drugs to learn whether they work in treating a specific~     cancer. Investigational means that the combination of drugs is still being studied and~     that research doctors are trying to find out more about it, such as the safest dose to use~     and the side effects they may cause. It also means that the FDA has not yet approved the~     combination.~      The two drugs being tested in this study are tivozanib and enzalutamide. Enzalutamide has~     been approved by the FDA for treatment of prostate cancer. On the other hand, tivozanib is~     still investigational, and has not been tested in a combination with enzalutamide before.~      Enzalutamide is an androgen receptor antagonist (it blocks the activity of the male sex~     hormones). Prostate cancers are initially dependent on the male hormone testosterone for~     growth. Hormonal therapies that lower testosterone or block the ability of testosterone to~     act at the level of the prostate cancer are currently among the most effective treatments~     for prostate cancers taht have spread to other body organs (metastasized). The effectiveness~     of hormonal treatments, however, is not permanent, and over time many prostate cancers~     progress in spite of these treatments. Enzalutamide is a drug that has been proven to help~     delay the progression of advanced prostate cancer on average for about 8 months.~      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking~     the blood supply to the tumor, so that the tumor does not receive the nutrients it needs to~     grow. The main goal of this study is to determine whether the combination of tivozanib and~     enzalutamide is more effective in delaying the progression of disease than when enzalutamide~     is given alone. This study will also determine whether treatment with the combination of the~     tivozanib and enzalutamide will have more side effects then treatment with enzalutamide~     alone.~   "
89491|NCT01885936|"~     In this study the study team proposes to investigate the efficacy of albuterol on motor~     function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme~     replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe~     Disease.~   "
89492|NCT01885923|"~     THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for~     schizophrenia and schizoaffective disorder by means of simple, highly cost-effective~     information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study~     duration, patients in the active group enrolled in ITAREPS will demonstrate statistically~     significantly reduced risk of hospitalization, decreased number of hospitalization days and~     reduced direct inpatient costs in comparison to control group not using the program.~   "
89493|NCT01885910|"~     This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel~     following combination treatment with with doxycycline and Aczone 5% gel can maintain~     therapeutic response.~   "
89494|NCT01885897|"~     This is a multi-center, phase I/II clinical trial for patients who have relapsed more than~     60 day after allogeneic transplant for a hematologic malignancy. The study consists of two~     phases. The dose finding phase is a modified version of a phase I trial and the extended~     phase is a modified version of a phase II trial.~      The primary objective of the dose finding phase is to determine the maximum tolerated,~     minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex~     (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will~     follow a standard 3+3 design of dose escalation for toxicity with an added feature of~     stopping early if efficacy is confirmed. There are six dose levels of ALT-803 for to~     determine the MTD/MED: 1, 3, 6, 10, 20, and 30 mcg/kg.~      Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase.~     The primary goal of this extended phase is to study the potential efficacy of ALT-803 in~     this patient population. Efficacy will be measured using rates of remission induction. An~     optimal Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients~     (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or~     more of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an~     additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.~   "
89521|NCT01885546|"~     This enhanced meter feature raises awareness among patients by providing additional~     information regarding their glycemic control between Healthcare Professional visits. This~     information may facilitate increased dialogue between patient and Healthcare Professionals~     and can remind patients of the importance of glycemic control.~      This study will evaluate a user's ability to obtain the enhanced meter feature.~   "
89498|NCT01885845|"~     Postpartum hemorrhage is one of the most common causes of maternal mortality and serious~     maternal morbidity, especially in the developing world. In India, hemorrhage is a major~     cause of maternal mortality: A study by the Register General in 1993 showed that 23 percent~     of all maternal deaths in rural areas were caused by hemorrhage (Sibley, 2005).~      The measurement of postpartum blood loss and identification of postpartum hemorrhage are~     important measures in efforts to prevent and treat postpartum hemorrhage. In recent years,~     researchers have employed several different methods to measure blood loss in hospital and~     community-based birth settings. Although research has demonstrated that these laboratory~     measures are more accurate then visual estimation techniques, no studies have explicitly~     documented the systematic differences (if any) among different collection modalities.~     Moreover, only a few of these studies have correlated measured blood loss with changes in~     hemoglobin levels experienced between the antepartum and postpartum period. The aim of this~     study is to compare variations in the measurement of blood loss obtained using two popular~     measurement methods: the Excellent BRASSS-V Drape™ and a modified version of the blood~     collection method developed by the World Health Organization (WHO).~   "
89499|NCT01885832|"~     Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2,~     3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment~     associated adverse events. Improvements in joint function as assessed by Western Ontario and~     McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.~   "
89500|NCT01885819|"~     Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is~     safe and useful procedure in inducing remission of RA in patients resistant to standard~     DMARD therapy.~   "
89501|NCT01885806|"~     We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation~     (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that~     rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.~   "
89502|NCT01885793|"~     This is a prospective study looking at ways to measure the cuff pressure of cuffed~     endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer~     of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or~     central venous pressure monitoring. The investigators previously did this study in vivo with~     ETTs in polyvinyl chloride (PVC) tracheas and we found that there is good correlation~     between the pressure readings using the MM and the IPMS. The purpose of the current study is~     to validate the in vitro findings in clinical situations.~   "
89503|NCT01885780|"~     This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the~     effectiveness of the femtolaser-assisted astigmatic keratotomy.~   "
89504|NCT01885767|"~     The NF Registry is a database of patient-reported experiences of living with~     neurofibromatosis. It also serves as a referral source for clinical trials.~   "
89505|NCT01885754|"~     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung~     cancer is the leading cancer-related death worldwide and it represents a pressing health~     issue. Patients with lung cancer are more likely to experience cachexia, a severe~     debilitating disorder causing fatigue, weight loss, muscle wasting and associated with~     reduced physical function, increased chemotherapy toxicity and reduced survival. This~     syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in~     about 20% of cases. However, despite the importance of cachexia in lung cancer, its~     mechanisms ans its relation with muscle function and effort tolerance are still unknown.~      Aim: To explore muscle function, signaling pathways and its relationship to impaired~     functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether~     they have cachexic state at diagnosis.~      Methods: This study will be conducted at the Institut universitaire de cardiologie et de~     pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated~     whether or not they have a cachexic state. The evaluation will need two visits separated by~     5 days.~      During the evaluation the following tests will be done:~        -  Anthropometric measures~        -  Level of daily physical activity~        -  Pulmonary function test~        -  Maximal incremental cardiopulmonary exercise test on ergocycle~        -  Endurance test on ergocycle~        -  Muscle function tests~        -  Magnetic stimulation~        -  Quadriceps biopsy~   "
89506|NCT01885741|"~     A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy~     (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15~     biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the~     procedure to assess clinical outcomes.~   "
89507|NCT01885728|"~     The primary objective of this study is to characterize the immune-modulatory effects of~     arginine-rich nutritional supplements in patients undergoing surgery. Numerical and~     functional changes of all circulating immune cells will be assessed with mass cytometry.~   "
89508|NCT01885715|"~     This study aims to find appropriate dose of neostigmine which is possible to reverse~     rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.~   "
89509|NCT01885702|"~     Objectives:~      In this Radboud University Nijmegen Medical Centre (RUNMC) initiated study our first~     objective is to investigate toxicity (safety and feasibility) of vaccination with~     frameshift-derived neoantigen-loaded DC of CRC patients with an MSI-positive CRC and persons~     who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.~      The secondary objectives of the study are:~        -  to demonstrate that peptide-loaded DC can induce or enhance an immune response to~          tumor-associated antigen CEA and specific frameshift-derived neoantigens in the study~          population.~        -  to study the pathological and clinical responses, e.g. disease-free survival,~          determined according to the standard protocol.~      Study design:~      This study is a phase I/II open-label study.~      Study population:~      Two groups of adults will be vaccinated:~      Group I) CRC patients, who are known to carry a germline MMR-gene mutation and patients with~     an MSI-positive CRC and yet unknown or negative MMR-gene mutation status.~      Group II) persons who are known to be carrier of a germline MMR-gene mutation with no signs~     of disease yet. All participants need to be HLA-A2.1 positive.~   "
89567|NCT01884948|"~     To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing~     postoperative morbidity and mortality after major liver resection.~   "
89510|NCT01885689|"~     This phase II trial studies how well clofarabine and melphalan before a donor stem cell~     transplant works in treating patients with a decrease in or disappearance of signs and~     symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic~     myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a~     donor stem cell transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into a patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan~     before transplant may help prevent the cancer from coming back after transplant, and they~     may cause fewer side effects than standard treatment.~   "
89511|NCT01885676|"~     -  Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in~          both men and women and is caused by the action of androgens in genetically predisposed~          individuals.~        -  This clinical trial was designed to evaluate the efficacy and safety of using a~          preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment~          of androgenetic alopecia.~   "
89512|NCT01885663|"~     This open label trial is conducted to investigate the efficacy and safety of allogeneic~     umbilical cord blood (UCB) therapy for patients with acquired brain injury.~   "
89513|NCT01885650|"~     Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes~     which is characterised by the production of thickened bodily secretions, affecting the~     function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is~     very difficult to clear, which can results in recurrent chest infections, which can lead to~     lung damage. therefore it is important to optimise the removal of sputum to try and prevent~     these complications. Traditionally, a variety of approaches are usually combined including~     inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise~     secretions and improve sputum clearance.~      There are many chest physiotherapy or airway clearance techniques (ACT) available including~     breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic~     Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest~     Oscillation (the Vest), or oscillatory devices such as the Flutter or Acapella. When~     people with CF have an infection or have severe disease often the effectiveness of ACTs can~     decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At~     this time it is necessary to re-assess ACTs and the addition of positive pressure to airway~     clearance techniques has been shown to be helpful in decreasing fatigue during chest~     physiotherapy.~      At present no research studies have reported an increase in sputum cleared with the addition~     of positive pressure, however it is thought that the ability to take a deeper breath when~     using positive pressure would help to improve sputum clearance. With clinical experience of~     the use of NIV with adult CF patients, the investigators aim to explore this objectively in~     this study.~      Research Question:~      Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive~     pressure to normal airway clearance techniques improve sputum clearance in stable adult~     patients with cystic fibrosis?~      Hypothesis~      The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance~     technique will lead to improvements in subjective ease of clearance and work of breathing~     during airway clearance and objectively increase sputum clearance, as well as being well~     tolerated in patients as an adjunct to airway clearance.~   "
89514|NCT01885637|"~     Danish studies have shown that the majority of palliative cancer patients wish to be cared~     for and spend the rest of their lives at home. Nevertheless > 50% of palliative cancer~     patients die in acute hospitals and these figures are found in countries with a highly~     developed palliative care service as well. Some studies have suggested that, among other~     causes, delays in the discharge process represent a significant obstacle for achieving care~     and treatment, and ultimately death at home. Therefore, this randomized controlled trial~     (RCT) aims at investigating an accelerated transition program from oncological treatment to~     continuous specialized palliative care at home for patients with incurable cancer. The~     primary objective of the study is to investigate whether an accelerated transition from~     oncology care to palliative home care significantly increases home care and death. The~     secondary objectives are to investigate whether the intervention improves symptom control~     and quality of life, increases survival, affects health care expenses, improves caregiver~     quality of life and burden, dyadic coping and grief outcomes. The study will take place in~     the departments of oncology at Rigshospitalet, where palliative cancer patients will enter~     the intervention or usual care arms. The intervention is an accelerated transition program,~     which consists of planning palliative home care and if needed optimization of facilities at~     home, and a transfer to home care within 5 days of informed consent. On day 1 at home the~     patient, informal caregiver, nurse, representatives of the specialized palliative care team~     and if possible the general practitioner and project psychologist meet to organize home~     care. A dyadic psychological intervention is offered to patients and their informal~     caregiver during specialized palliative care at home and to bereaved caregivers. The control~     group will be treated according to the usual principles, but if inadequate palliative care~     is observed in this group, the study group is obliged to involve responsible professionals.~     Both groups will be followed by assessments of the patient and the caregiver for up to 6~     months and the caregivers 19 month after the patient's death.~   "
89515|NCT01885624|"~     The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08~     after single i.v. infusion to the adult healthy volunteers. Additionally were assessed~     infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single~     i.v. infusion and to explore TAB mechanism-of-action biomarkers.~   "
89516|NCT01885611|"~     To date, there has been no clinical investigation on the effects of virgin coconut oil (VCO)~     oral supplementation on patients with Hansen's disease (HD) undergoing medical treatment.~     This study aims to examine the possible protective effect of exogenous supplementation of~     VCO on the oxidative stress, antioxidant status, and treatment response among HD patients.~     Treatment response will be defined as the clinical changes in cutaneous and neurologic~     manifestations as measured by the clinical response score. This study also aims to~     investigate the potential of VCO as an adjunct to Multi-Drug Therapy (MDT) in mitigating~     lepra reactions.~   "
89517|NCT01885598|"~     The primary objective of this study is to examine the safety profile of Eliquis in Korean~     nonvalvular atrial fibrillation patients.~   "
89518|NCT01885585|"~     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the~     clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the~     safety and effectiveness information about Eliquis in general practice~   "
89519|NCT01885572|"~     This multicentre, non-randomised, observational clinical device investigation will be~     performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the~     improvement of the patients' quality of life as well as on the rate of complications of the~     device under investigation.~      The objective of this clinical investigation is to establish the feasibility, efficacy and~     safety of the TiLOOP® Bra.~   "
89520|NCT01885559|"~     The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the~     progression of cystic disease and on the decline in renal function in autosomal dominant~     kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical~     trials targeting different levels of kidney function: 1) early disease defined by GFR >60~     mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60~     mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or~     B, over the first three years. Participants enrolled in Study B will be followed for~     five-to-eight years, with the average length of follow-up being six and a half years.~      Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an~     angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.~   "
89522|NCT01885533|"~     Thyroid dysfunction following radioiodine for Graves' disease is common, potentially~     detrimental and avoidable. A variety of clinical strategies are employed in the~     post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen,~     which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early~     thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of~     these is most effective in avoiding dysthyroidism, is unknown. This study aims to address~     this lack of evidence. It will focus on Graves' disease as this is the commonest cause of~     thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into~     potential strategies for improving important clinical outcomes.~   "
89523|NCT01885520|"~     The purpose of this study is to evaluate the food effect on the pharmacokinetics of~     eperisone HCl SR tablet~   "
89524|NCT01885507|"~     Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end~     expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic~     approach to extubation may decrease the rate of extubation failure and enhance outcomes of~     brain-injured patients.~      We hypothesized that medical education and implementation of an evidence-base care bundle~     associating protective ventilation and systemic approach to extubation can reduce the~     duration of mechanical ventilation in brain-injured patients.~   "
89525|NCT01885494|"~     AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been~     applied during AFF008 with regard to safety as well as immunological-, radiological and~     clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied.~     Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at~     the occasion of 4 quarterly visits. This is offered to patients who received PD01A~     vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will~     ensure standardized and controlled management of individuals who have received PD01A as part~     of AFF008, the Phase I study analyzing for the first time in humans this first in class~     candidate.~   "
89526|NCT01885481|"~     Particle steroid drug such as triamcinolone has been used widely for epidural steroid~     injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using~     triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and~     betamethasone become only candidate drugs for ESI in Korea and the investigators are curious~     about the effectiveness and safety of both drugs due to limitation of information about~     comparison of two drugs in previous literature. So, this study aims to compare the~     effectiveness and safety of both drugs and our hypothesis is that there is no difference of~     the effectiveness between dexamethasone and betamethasone at 2 weeks after ESI.~   "
89527|NCT01885468|"~     This study is to verify the use of a hand held tool to verify the new setting of a~     hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's~     head, which is how settings are verified currently.~   "
89528|NCT01885455|"~     This is a randomized, interventional trial in which the navigation is the intervention.~     Phase is not applicable. The study is a randomized trial to evaluate the impact of a~     nurse-led patient navigation intervention in improving rates of receipt of lung-directed~     therapy with curative intent (LDTCI) among African Americans with early stage lung cancer.~     Study sites are cluster-randomized to either the usual care study arm or the to the~     navigation intervention study arm. Randomization occurred at the level of the study site~     rather than at the level of individual participants. There are two arms.~   "
89529|NCT01885442|"~     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need~     advanced life-support. Survivors of critical illness are very vulnerable to weakness and~     disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as~     long as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches~     to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The~     investigators will offer patients in-bed cycling while they are needing a breathing machine,~     to help them recover from weakness as fast as possible. Before doing a larger trial testing~     if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the~     investigators do it?) are needed.~      Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill~     patients who need breathing machines.~      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to~     survive their ICU stay are eligible. Specially trained physiotherapists will provide~     patients with 30 minutes of in-bed cycling each day while they are in the ICU.~      Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of~     patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility:~     whether patients can cycle on most days of their ICU stay, whether patients and their~     families agree to be a part of the study, and whether the investigators can assess patients'~     strength in the ICU and at hospital discharge.~      Relevance: As the Canadian population ages, the demand for breathing machines during acute~     illness will increase dramatically. Effective methods of physiotherapy are needed for~     critically ill patients to minimize muscle weakness, speed recovery, and improve quality of~     life. This pilot study is the first of several future larger studies about in-bed cycling in~     the ICU. This program of research will help patients needing life support to regain their~     strength and recover as fast as possible from critical illness.~   "
89530|NCT01885429|"~     Muscle mass is normally maintained through the regulated balance between the processes of~     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old~     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase~     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids~     are ones that must be consumed through food, while non-essential amino acids can be made by~     our body. Interestingly, the essential amino acids are all that are required to increase the~     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to~     be particularly important in regulating protein synthesis. However, how leucine is able to~     increase protein synthesis is not entirely understood. Previously, it has been shown that~     20-25 g of high-quality protein, such as that found in milk (whey), appears to be the amount~     of protein that maximizes the rate of muscle protein synthesis after performing a bout of~     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after~     ingesting different amounts of protein and amino acids. We will measure muscle protein~     synthesis after consumption of the beverage a participant is randomized to in a leg that has~     done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise.~     Amino acids are 'strung-together' to make protein. The 'essential' amino acids must be~     consumed through food because our body cannot make them, thus they are consumed when you eat~     protein rich foods like milk or chicken. Leucine, isoleucine, and valine are simply 3 of the~     8 essential amino acids that make up dietary protein. Unlike essential amino acids,~     'non-essential' amino acids may be synthesized by the body, however they are also present in~     protein rich foods like chicken or milk. We aim to determine if it is the leucine content~     found in 25 g of whey protein that is primarily responsible for maximizing muscle protein~     synthesis at rest and following resistance exercise. We also wish to determine how muscle~     genes and metabolism respond to this protocol.~   "
89531|NCT01885416|"~     The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic~     response to the ingestion of three different meals in obese subjects. The administered meals~     will differ in the proportion of dairy products. Postprandial response will be monitored~     during 6 hours after meal consumption.~   "
89532|NCT01885403|"~     The aim of the study is to determine the feasibility of collecting respiratory parameters~     during recompensation following ADHF (Acute Decompensated Heart Failure)with non-invasive~     measurements. This could lead to a better understanding of how respiratory parameters may~     change during re-compensation therapy and could also be a comfortable method for patients.~   "
89533|NCT01885390|"~     The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in~     patients with treatment-resistant or uncontrolled hypertension.~   "
89534|NCT01885377|"~     Objective: A randomized clinical trial in order to evaluate the efficacy of a specific~     exercise strategy for patients with subacromial pain.~      Hypothesis:~      H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder~     function and/or shoulder pain.~      H0 - No difference between the two exercise strategies (specific exercise strategy and~     active control exercises).~      Method: Patients attending primary care with subacromial pain are offered participation. If~     accepted, they will participate in a three month rehabilitation program. The duration of~     symptoms can vary from 2 weeks and longer. The patients will be randomized to either~     rehabilitation; the specific exercise strategy or active control exercises. All patients has~     an equal number of sessions with the physical therapist (PT) to offer similar attention and~     support with exercise performance. A blinded physical therapist evaluates the following~     outcomes at baseline and after three-, six and twelve months:~      Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes;~     Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by~     Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient~     Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave~     and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound~     to reveal the status of the rotator cuff.~      Additional to the analysis of treatment effect on shoulder function and pain, factors~     influencing and explaining the CM-score at follow-ups will be analyzed.~      This study is warranted in order to evaluate if an earlier reported positive effect on~     shoulder function and pain with the specific exercise strategy, in patients on waiting list~     for subacromial decompression, can be repeated in the primary care population of patients~     with subacromial pain. There is no consensus about first-line exercises for patients with~     subacromial pain, and these positive results on pain and shoulder function need to be~     reproduced in primary care before they can be recommended and implemented. Further,~     knowledge about which factors that can be used in prediction rules for patients that will~     respond to the exercises or needs surgery is lacking.~   "
89535|NCT01885364|"~     Pain on injection of propofol is a common side effect. The present study was designed to~     investigate the effect of esmolol on pain on propofol injection and to compare it with~     remifentanil and placebo.~   "
89536|NCT01885351|"~     This study involves 3 phases that modifies current Interactive Preventative Health~     Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual~     colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific~     barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to~     assess their CRCS test preferences and corresponding test-specific barriers in real time.~     Based on patient characteristics (e.g. age, personal and family history, physician CRCS~     recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos~     will appear in the pop-up screens to address/reduce the top patient-reported, test-specific~     CRCS barriers while incorporating an action plan for CRCS adherence. The investigators~     hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS~     knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.~   "
89537|NCT01885338|"~     This study will evaluate the effect of the dietary supplement N-acetylcysteine (NAC) on~     electrophysiologic (EEG) markers related to cognition, as well as performance on~     psychological tests measuring cognition. The primary hypothesis is that participants treated~     with NAC will show improvements in cognitive function, as measured by EEG and~     performance-based tests.~   "
89538|NCT01885325|"~     The study addresses a critical public health problem, childhood obesity, by testing a~     physical activity intervention in the types of preschools that millions of children attend.~     Information gained in this study may lead to adoption of preschool policies and~     instructional practices that increase physical activity and reduce the risk of obesity in~     preschool children.~   "
89539|NCT01885312|"~     This study is designed to develop and test a tailored adaptive text messaging/short message~     service (SMS) intervention for individuals interested in stopping or reducing their alcohol~     consumption; and test and compare it to tailored but static, once a day messaging, gain~     framed messaging, and ecological momentary assessment only.~   "
89540|NCT01885299|"~     The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT~     (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment~     practices and outcomes to help determine, over time, the most effective use of these systems~     in management of patients with life threatening tumors and other diseases. (This study was~     formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a~     CyberKnife subset of RSSearch.)~   "
89541|NCT01885286|"~     The investigators are testing a novel surgical device to facilitate safe circumcision among~     adult males. The investigators hypothesize that this device will allow non-medical providers~     to perform safe surgical circumcision without adverse events.~   "
89542|NCT01885273|"~     The study is to examine the effectiveness of cleansing wound with pressurized irrigation~     method compared with conventional practice of swabbing on the wound healing and infection of~     acute and chronic wound, and to evaluate the patient's physical symptoms related to wound,~     patient's satisfaction to cleansing method, and cost of materials used between the two~     groups.~      Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion~     criteria will be recruited and randomly assigned to be cleansed using either: pressurized~     irrigation method (experimental group) or swabbing method (control group).~      244 patients will be recruited in the study. This will take place in four community health~     centres run by the Hospital Authority in Hong Kong. The wounds of participants will be~     cleansed using the assigned method for a six week period. The clinic staff nurse is~     responsible for the ongoing assessment of the wound.~      Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end~     of six-week period if the wounds have not healed. Demographic data and information related~     to the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound~     discomfort, pain and odour will be collected at enrolment. Information related to the wound~     and subjective measures of patient satisfaction -feeling of cleanliness, liking, and of~     staff satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the~     cleansing method using VAS will be assessed at completion of treatment. A list of cost~     measurements for the wound cleansing would also be captured.~   "
89543|NCT01885260|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     ISIS-GCGRRx in combination with metformin versus placebo + metformin~   "
89544|NCT01885247|"~     The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a~     progression of therapeutic options and on a sensitization to physical activity.~      For these patients selected on OCBP stage 2, the treatment options include Long Acting~     Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic~     (LAMA) or both (LAMA+LABA).~      The purpose of this study is to observe in common clinical practice the benefit of physical~     activity on quality of life, dyspnoea and walking distance for these patients under~     treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies~     (LABA/LAMA/LABA+LAMA) benefit from physical activity.~   "
89545|NCT01885234|"~     The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in~     pregnant women with gestational diabetes or chronic hypertension after an aerobic training~     in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks'~     pregnant.~      Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will~     perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45~     minutes each session. Two control groups (gestational diabetes and chronic hypertension, n =~     16 each) will perform an unique session/week of relaxation and stretching.~      Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of~     the newborn.~   "
89546|NCT01885221|"~     In an earlier study, the investigators developed a guidebook that taught women supportive~     behaviors to help their husbands/partners quit smokeless tobacco. This study will create a~     website using the information in the guidebook, along with interactive features, videos, and~     forums. The investigators will then conduct a randomized trial comparing an intervention~     group (receiving website access and the printed guidebook) with a delayed treatment control~     condition, to learn if the support intervention can effectively teach women supportive~     behaviors and thereby increase their partners' smokeless tobacco cessation rates.~   "
89547|NCT01885208|"~     This trial is conducted in Europe and North and South America. The aim of the trial is to~     investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended~     release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with~     type 2 diabetes.~   "
89548|NCT01885195|"~     The purpose of this signal seeking study is to determine whether treatment with MEK162~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study~   "
89549|NCT01885182|"~     To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets~     compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain~   "
89550|NCT01885169|"~     Influenza (the flu) is one of the most common respiratory viruses associated with~     respiratory deteriorations in children and adolescents with cystic fibrosis. These~     deteriorations usually mean antibiotics, hospitalizations, and worsening of pulmonary~     function tests. A new flu vaccine has been recently approved for use in Canada (Flumist®).~     What is particular about this flu vaccine is that it is a spray in the nose, which mimics~     how influenza usually infects us. This particular vaccine protects children and adolescents~     much better than the regular injectable flu shot.~      This new vaccine has been given to > 2,000 healthy children and to >2,000 children with~     asthma and well tolerated. The investigators want to know if Flumist® is well tolerated in~     children with CF and does not cause worsening of respiratory symptoms. The investigators~     will conduct a study where all participants will receive Flumist® in the nose. This study is~     particularly important because its results will provide safety information on a vaccine that~     is more efficacious for a population who needs safe and easy to administer protection~     against the flu.~   "
89551|NCT01885156|"~     To see how well Naftin 1% cream works when applied once daily to the affected area. The~     results will be compared to those using a placebo cream, which is a cream with no active~     ingredient. Safety will also be measured.~   "
89552|NCT01885143|"~     Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of~     acceptable quality as defined in the relevant FDA guidance document before and after~     artifact correction and in standard screening images. Lossy compression will also be~     evaluated to demonstrate that images are of acceptable quality when lossy compression is~     enabled.~   "
89553|NCT01885130|"~     Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer~     or irritant in certain individuals.~   "
89554|NCT01885117|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and~     the antibody response to each influenza vaccine antigen, as measured by Single Radial~     Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post~     immunization.~      The vaccine composition will be based on the World Health Organization (WHO) recommended~     influenza strains for the 2013/2014 Northern Hemisphere vaccine.~      The results of this study are intended to support the use of this vaccine in future~     influenza seasons if the recommended vaccine composition remains the same, in compliance~     with the requirements of the current European Union (EU) recommendations for clinical trials~     related to yearly licensing of influenza vaccines.~   "
89555|NCT01885104|"~     The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG~     3350 solution concentrate to oral ingestion of a placebo solution concentrate, in~     participants with constipation.~   "
89556|NCT01885091|"~     The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin~     0.1%) in Thai patients, on the basis of the severity and clinical signs of facial~     photodamage.~   "
89557|NCT01885078|"~     The purpose of this study is to investigate the long-term safety and any side effects of~     baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis~     study.~      The study provides for 4 years of additional treatment with baricitinib.~   "
89558|NCT01885065|"~     The purpose of this study is to determine whether continuous use of edible, gel-based~     artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms~     of dry mouth and improve quality of patients' saliva.~   "
89568|NCT01884935|"~     The primary objective of the study is to determine the pharmacokinetic (PK) profile of~     multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple~     sclerosis (RRMS). The secondary objectives are as follows: to characterize the~     pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to~     explore the safety and tolerability of multiple doses of natalizumab in the pediatric~     population.~   "
89569|NCT01884922|"~     Multicenter, open label, prospective study including successively a phase I trial and then a~     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both~     drugs, vinblastine and nilotinib.~   "
89570|NCT01884909|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy adult human subjects.~   "
89559|NCT01885052|"~     Background:~      - Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29~     stop smoking. This is part of a larger online stop-smoking program by the National Cancer~     Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks~     of follow-up messages. Program participants will receive texts on their cell phones,~     including tips, information, and motivational messages, and then fill out surveys.~      Objectives:~      - To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.~      Eligibility:~      - Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop~     smoking in the next 30 days.~      Design:~        -  Participants will receive a certain number of text messages during the 8-week study.~          They will receive between 0 to 5 messages per day (or up to a total of 130 messages).~        -  Participants will first fill out a survey about their smoking and quitting experiences.~          Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after~          this survey.~        -  Participants will take four other surveys online, one during the program and three more~          after they ve completed the program. Each survey will take about 10 20 minutes and asks~          about their smoking habits and views on smoking and quitting. Each survey will be sent~          by email, with reminders sent by email or telephone.~        -  Participants will receive an iTunes or Amazon gift card for completing each survey~          honestly.~   "
89560|NCT01885039|"~     Background:~      - The Chinese University of Hong Kong and the National Cancer Institute are conducting a~     breast tissue study in connection with another study on breast health. This larger study~     will look at breast health in women who live in Hong Kong. Women in the breast health study~     will provide a breast tissue sample during biopsy surgery. Researchers want to use part of~     the sample to study changes in breast tissue that are related to breast diseases. This~     sample study is part of the larger study.~      Objectives:~      - To look at changes in breast tissue that are related to breast diseases.~      Eligibility:~        -  Women who are participating in the Hong Kong breast health study.~        -  Participants must be having a biopsy to remove breast tissue for study.~      Design:~        -  Participants will have a biopsy to remove a breast tissue sample. Most of the sample~          will be used for diagnosis. A portion of the leftover tissue will be used for this~          study.~        -  No extra surgery will be required.~        -  Treatment will not be provided as part of this study.~   "
89561|NCT01885026|"~     Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients~     treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief~     Internet intervention for problematic alcohol and drug use offers self-screening, in-depth~     self-reporting, personalized feedback and treatment recommendations as well as an electronic~     diary. Progress over time is shown in diagrams detailing consumption levels.~      Method: This is a two-armed randomized controlled design, measuring outcomes in terms of~     changes in problematic alcohol use up to one year after study recruitment. Participants with~     problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use~     (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen~     referral or Control group. Outcomes on alcohol and drug use as well as health-related~     symptoms are assessed after 3, 6 and 12 months.~      The hypothesis is that the group receiving the eScreen intervention will reduce their~     alcohol/drug use to a larger extent than the control group at follow-up compared to the~     baseline level.~   "
89562|NCT01885013|"~     This is a phase II comparative randomized clinical trial.~      Eligible patients will be randomized (1:1) to:~      Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide~      Statistical Considerations:~      In this randomized phase II study, the sample size was calculated basing on the primary~     end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.~      To find an advantage of 4 months of median time to progression (6 months in the control arm~     B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a~     period of 24 months and will be considered further 12-month of follow-up. The primary~     analysis of the study will be conducted in accordance with the intention to treat~     principle, the secondary analysis will be conducted in the per protocol population.~   "
89563|NCT01885000|"~     The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of~     patients)of a new drug for the treatment of erythema of rosacea (central facial redness).~     The feedback of patients receiving the active drug will be compared to the feedback of~     patients receiving the placebo.~   "
89564|NCT01884987|"~     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation~     therapy for cancers, and may have a devastating effect on the patient's quality of life~     (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard~     therapy has been suggested for CRN. In our clinical practice, we have used~     monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully~     reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.~   "
89565|NCT01884974|"~     Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated~     mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative~     diseases (CMPD) associated with pulmonary hypertension were included in the group 5~     category, corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD~     include chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic~     eosinophilic leukaemia (which primarily express a myeloid phenotype and polycythaemia vera),~     idiopathic myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic~     hyperplasia predominates.~      The purpose of this research:~        1. Assess Prevalence of PH in patients with CMPD in Northern Israel~        2. Describe the demographics and clinical course in patients with CMPD who are diagnosed~          with PH.~   "
89566|NCT01884961|"~     Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or~     renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of~     immunologic and therapeutic response~      Phase: Proof of Principle phase II study~      Study Design: Single center, open-label trial to assess the immune response and potential~     biomarkers predictive of response~      Study Duration:~      Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up~     every three months~      Number of Subjects:~      Mini-max two-stage Simon design:~      • Step 1: 7 patients enrolled~      If tumor antigen-specific immune response is observed in at least 3 patients:~      • Step 2: recruitment of an additional 12 patients~   "
89577|NCT01884818|"~     The study includes two phases. In phase one the reliability of thoracic spine mobility~     measurements are studied in subjects with thoracic spine pain. In phase two the reliable~     measurements are used to measure the effects of thoracic spine manipulation in subjects with~     thoracic spine pain. The changes in pain is measured as well.~      In second phase the control group receives TNS treatment six times at home as a placebo so~     that the power of TNS is limited to very low level. The number of treatments are controlled~     as well as the time of treatment. The treatment group receives six manipulation treatments~     within 3 week period. The effects are measured immediately after the treatment weeks, and 3~     and 8 week follow-up. Moreover the one year follow-up will be performed by mail~     questionnaire.~   "
89578|NCT01884805|"~     The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to~     measure optical aberrations in hyperopic eyes.~      The study hypotheses are the:~        -  Ability to measure optical aberrations in hypermetropia.~        -  Knowledge of optical aberrations of the eye hyperopic.~        -  To adapt therapeutic management in optical aberrations measured.~   "
89579|NCT01884792|"~     The study is a crossover, pilot trial examining the acute effects of standing on blood sugar~     in prediabetic, working adults. Participants will complete oral glucose tolerance testing,~     once while sitting and once while standing. They will also wear a continuous blood sugar~     monitor once while sitting at their desk for a week and once while using their desk as a~     sit-stand desk with a goal of standing intermittently for at least half of the work day.~     Physical activity levels will be measured with an accelerometer. The primary study~     hypothesis is that blood sugar will differ between the sitting and standing conditions for~     each of the tests performed.~   "
89580|NCT01884779|"~     Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired~     immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The~     diagnosis of this disease requires invasives procedures, laboratory performance, and delays~     up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and~     Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and~     urine samples that looks interesting in endemic areas, particularly in developing countries.~     The study aims to measure the proportion of HIV-infected patients hospitalized or in~     outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum~     and/or urinary antigen detection tests are positive for Histoplasma capsulatum var.~     capsulatum.~   "
89581|NCT01884766|"~     In many fields of medicine, except seizure disorders, blood biomarkers have captured an~     integrated part of diagnostic decision making, including copeptin, the surrogate marker of~     vasopressin release. There are strong arguments to hypothesize circulating copeptin is~     elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and~     that copeptin is predictive for complexity and relapse at least in FS. Although long-term~     morbidity and mortality are both low in FS, there is high anxiety among parents because of a~     lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by~     adding important diagnostic and prognostic information. Eventually, less children may~     receive needlessly over years fever drugs or anti-epileptic drugs.~   "
89582|NCT01884753|"~     The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D~     ultrasound examinations, and to correlate the sonographic findings with urodynamic~     variables, pad weights and LUTS. Besides, the associations of the blood flow of~     vagina/urethra and sexual dysfunction can be explored.~   "
89583|NCT01884740|"~     Central nervous system (CNS) malignancies are the second most common malignancy and the most~     common solid tumor of childhood, including adolescence. Annually in the United States,~     approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be~     increasing. CNS tumors are the leading cause of death from solid tumors in children.~     Survival duration after diagnosis in children is highly variable depending in part on age at~     diagnosis, location of tumor, and extent of resection; however, most children with high~     grade glioma die within 3 years of diagnosis. All patients with high grade glioma experience~     a recurrence after first-line therapy, so improvements in both first-line and salvage~     therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if~     currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have~     shown in previous phase I trials that a single Superselective Intra-arterial Cerebral~     Infusion (SIACI) of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent~     glioblastoma multiforme (GBM) in adults, and we are currently evaluating the efficacy of~     this treatment. Therefore, this phase I/II clinical research trial is an extension of that~     trial in that we seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab~     is safe and effective in the treatment of relapsed/refractory glioma in patients <22 years~     of age. We expect that this project will provide important information regarding the utility~     of SIACI Cetuximab and Bevacizumab therapy for malignant glioma in patients <22 years of age~     and may alter the way these drugs are delivered to our patients in the near future.~   "
89584|NCT01884727|"~     To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis:~     consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will~     significantly elevate 24-h resting energy expenditure as compared to consumption of a~     placebo control (salt water, same dietary intake).~   "
89585|NCT01884714|"~     The purpose of this study is to better understand the genetic and metabolic differences in~     obese individuals with and without type 2 diabetes. It is expected that this research will~     help improve our understanding of the variability observed between obese and diabetic~     individuals.~   "
89586|NCT01884701|"~     The current study is a prospective, single-arm, non-randomized, multi-center study to~     evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions~     during endovascular intervention for femoral-popliteal occlusive disease.~   "
89587|NCT01884688|"~     The purpose of this study is to determine the safety and in vivo persistence and expansion~     of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.~   "
89588|NCT01884675|"~     It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic~     thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed~     treatment options exist. This Phase III, randomized, double-blind placebo controlled~     parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5~     milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160~     subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out~     rate.~   "
89589|NCT01884662|"~     Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of~     the most problematic of secondary conditions that is minimally to modestly responsive to~     currently available treatments. It is usually described as burning or stabbing, and is~     located at or below the level at which their sensation changes from normal to impaired;~     persons with no feeling at all in their legs for example can experience pain in the legs.~     The purpose of this project is to further investigate the use of a novel visual stimulation~     treatment; a technique that has shown benefit in other populations with chronic pain~     secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR)~     walking - will be examined. Should this treatment show benefit, a portable, accessible means~     of treatment will be available for persons with SCI and for whom transportation to health~     care providers is often difficult.~   "
89590|NCT01884649|"~     Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical~     inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this~     study, we hypothesised that the serum fetuin A levels could be found to be low due to~     inflammation in patients with Hashimoto thyroiditis~   "
89591|NCT01884636|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole~     will be assessed alone and in combination with methotrexate.~   "
89592|NCT01884623|"~     To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first~     line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC.~     Efficacy assessed by failure free survival~   "
89593|NCT01884610|"~     Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising~     donor peripheral blood stem cells as an alternative to bone marrow harvesting for the~     purpose of recipient stem cell transplantation. The principal objective of the research is~     to study any longterm genetic effects of GCSF in the peripheral blood white cells of~     unrelated blood stem cell donors.~      The study subjects will be Retrospective and Prospective voluntary unrelated donors on the~     Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University~     College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free~     Hospital and BUPA Glen Vale in Bristol.~      All participants in the Prospective Arm will be asked to donate one 5−10ml sample of blood~     at study entry prior to stem cell donation and further samples at 120 and 360 days post~     donation. Those found to carry aneuploid cell clones at these time points will be asked for~     a further 5−10ml blood sample at least twice − at the end of 24 months and 36 months~     respectively. The Retrospective and Positive Control group will be asked to supply one~     5−10ml sample of blood.~   "
89594|NCT01884597|"~     This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal~     choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.~   "
89595|NCT01884584|"~     The surgeon may remove a very small amount of additional tissue compared to what would be~     removed if you were not enrolled in the study. This tissue may prove to contain tumor or it~     may contain normal tissue. The surgical cavity will be examined by a special laser pen after~     the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells~     where the ICG dye collected are still remaining and the surgeon would then remove those.~     After the tumor and the tissue around it are removed and sent to the laboratory, the tissue~     may be examined using that same laser pen to see where the cancer cells are and compare that~     to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is~     hoped that what the dye shows and what is seen with the microscope will be alike.~   "
89596|NCT01884571|"~     This is a multicenter, 15-month study evaluating the effect of immunosuppression treatment~     on the rate of change on the ALS Functional Rating Scale (Revised) (ALSFRS-R) score in up to~     33 subjects with Amyotrophic Lateral Sclerosis (ALS).~   "
89597|NCT01884558|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole~     will be assessed alone and in combination with metformin.~   "
89598|NCT01884545|"~     The purpose of this study is to examine whether the use of genetic test information and/or~     health coaching in patient risk counseling for heart disease and diabetes affect health~     behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents~     and Air Force retiree patients.~      Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned~     to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information~     (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health~     coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected~     for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk~     markers. Participants in the two groups that include health coaching will be assigned to a~     trained certified health coach for a period of 6 months. The duration of the study is 12~     months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys~     at 6 weeks and 3 month time points.~   "
89599|NCT01884532|"~     The purpose of this clinical study is to evaluate blood metal ion levels as a function of~     time of implantation for the ASR-XL MoM system.~   "
89600|NCT01884519|"~     The purpose of this study is to assess, in adults 18 years of age and above, the~     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit SSW~     2013/2014, containing the three vaccine influenza strains (two A strains and one B strain)~     for the 2013/2014 season.~   "
89601|NCT01884506|"~     A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25~     obese). In each subject blood volume will be determined using the minimally invasive carbon~     monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test~     meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will~     further be determined using a second labeled test meal (substudy 2). In addition,~     inflammation, hepcidin and iron status will be determined. In order to study the effect of~     body fat content on blood volume and iron absorption weight and height will be measured, and~     body fat will de determined by dual energy X-ray absorptiometry.~   "
90515|NCT01872468|"~     The propose of study is to study if an informative intervention and a structured follow-up~     carried out in health centres of primary care in patients with chronic kidney failure, stage~     3, is more effective than the current follow-up in slowing the disease progression measured~     by the glomerular filtration rate.~   "
89602|NCT01884493|"~     The gait symptoms are usually refractory to the dopaminergic agents and some other~     resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for~     in this regard. To study the impact of rTMS, investigators will adopt a domestically~     developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the~     electroencephalographic and electromyographic signals for PD patients when walking in the~     gait laboratory or when conducting leg dorsiflexion movement on sitting.~   "
89603|NCT01884480|"~     In Kidney transplant recipients Once daily Tacrolimus has the poteb]ntial advantage of~     better adnerence, and perhpas improvement in reanl function compred with the twice daily~     tacrolimus formulation.~      Our center has the largest experience in North America with once-daily tacrolimus (~     advagraf) in Renal transplant recipients.~      Recently we converted ~500 stable patients from the twice daily to once-daily tacrolimus.~      We are interested in:~        1. change in renal function~        2. dose changes based on ethnic diveristy~        3. dose changes based on pharmacogenetics~      This will helpnus understand better ways to utilize this anti-rejection medication~   "
89604|NCT01884467|"~     Recurrent UTIs are common among patients on IC. These create significant patient morbidity~     and healthcare burden. In desperation, many physicians prescribe prophylactic oral or~     intravesical antibiotics. This practice is common among our Gillette clinic patients.~     However, the benefit is unclear and the risks are not insignificant. As such, practice~     variation is significant. In order to better define the evidence for or against gentamicin~     bladder irrigation and thus inform clinical practice both locally at our Gillette urology~     clinic and for practitioners at large we will pursue the following specific aims:~        1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among~          a population of Gillette patients on IC with and without gentamicin bladder~          instillation.~        2. Compare antibiotic resistance rates among a population of Gillette patients on IC with~          and without gentamicin bladder instillation.~   "
89605|NCT01884454|"~     In view of the hormonal changes induced by both sleep deprivation and obstructive sleep~     apnea syndrome (OSA), and the importance of maintaining these hormones in reproductive~     processes. The present study aims to evaluate the effects of the OSA or sleep deprivation~     (total or selective REM sleep for 48h) on reproductive function in adult men with normal~     body mass index.~   "
89606|NCT01884441|"~     Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a~     higher response rate with the reduction of toxic side effects~   "
89607|NCT01884428|"~     study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV~     (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order~     to determine the recommended phase II dose~   "
89608|NCT01884415|"~     The objective of this clinical trial is to compare the response rate obtained with two~     different vaccination schemes against HBV in cirrhotic patients. These patients must be~     candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml)~     after three intramuscular doses of 40 µg.~   "
89609|NCT01884402|"~     Primary objective:~      • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to~     allow optimize treatment.~   "
89610|NCT01884389|"~     This study is testing a navigation program for early palliative care provided in tandem with~     HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and~     morbidity related to their co-morbid chronic conditions. Participants are enrolled for a~     period of 36 months, with data collection at enrollment and every 9 months after, for a~     total of 5 data collection time points. Study participants enrolled will be randomized into~     one of two groups: control or intervention. Control group participants will receive control~     calls in between survey data collection time points. Intervention group participants will~     participate in a Navigation Program which includes home visits and phone calls with an~     advanced practice nurse (APN) and licensed social worker (LSW), as well as visits / calls by~     a volunteer if desired. The frequency of visits / calls will be determined based on level of~     need (high, medium or low).~      The specific aims of the study are to: 1) identify needs and preferences for palliative care~     and advance care planning for PLWH, in order to tailor an existing Navigation Program for~     this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes~     of quality of life, symptom burden, coping ability, and advance care planning; and 3)~     determine if effectiveness of the HIV Navigation Program intervention differs by age,~     gender, ethnicity, education, income level, and level of palliative care service need.~   "
89611|NCT01884376|"~     The aim of this study is the development and initial clinical application of the nerve guide~     Neuromaix in humans to provide evidence for the safety and performance of the device.~      Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve~     discontinuity, and to create a conduit for axonal growth across the nerve gap.~   "
89612|NCT01884363|"~     This study will examine whether a twelve-week intervention with one ounce (28 g) per day of~     walnuts improves endothelial function measured non-invasively using finger probe~     (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.~   "
89613|NCT01884350|"~     The study purpose is to assess the impact of an educational program on patient adherence in~     patients taking Apixaban for SPAF at 24 weeks~   "
89614|NCT01884337|"~     The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of~     Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip~     replacement~   "
89615|NCT01884324|"~     Primary objective: to test the hypothesis that elective early delivery will protect the~     fetal bowel from the deleterious intrauterine factors late in the pregnancy and will be~     associated with improved neonatal outcomes.~      Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal~     surgical management of infants with gastroschisis.~   "
89616|NCT01884311|"~     The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF.~     The secondary objectives are to assess the safety of Subgam-VF and refine the dose~     adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous~     immunoglobulin (IGIV) therapy.~   "
89988|NCT01879449|"~     The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity~     at a single long-term care facility for veterans and their spouses in Murfreesboro,~     Tennessee. These data will be used to strengthen a future grant application to the~     Department of Defense in response to their ongoing Traumatic Brain Injury initiative.~   "
89617|NCT01884298|"~     In General anesthesia, two main ways of pain control are used intra-operatively, one is~     opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is~     potent and more effective , and also the benefits of stress block, less depression of~     breath. however, the epidural technique often causes more drop of blood pressure, especially~     in dehydrated patients. The investigators designed the trial to see if the benefit weigh out~     the potential risk of epidural in isolated hypertensive patients.~   "
89618|NCT01884285|"~     This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients~     with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer~     (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient/mutated or PIK3CB~     mutated/amplified advanced solid malignancies as monotherapy and in combination with~     abiraterone acetate or AZD2014.~   "
89619|NCT01884272|"~     This is a drug-drug interaction study in healthy volunteers to evaluate the potential~     pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and~     leinurad on the non-steroidal anti-inflammatory drugs.~   "
89620|NCT01884259|"~     This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel,~     cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.~   "
89621|NCT01884246|"~     Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue~     of having high rates of multiple CVD risk factors. There is a critical need to develop and~     test CVD risk reducing interventions that are appropriate and effective in Appalachia. In~     the absence of such interventions, the dramatic CVD disparities seen in this area will~     continue to rise.~      Lifestyle interventions reduce CVD risk by 44%. The investigators and others have~     demonstrated that lifestyle change is most effective when patients are given the tools to~     engage in effective self-care, and that interventions individualized to patients' specific~     needs and barriers are more effective than interventions that are not. The central~     hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must~     focus on patient-centered lifestyle change that increase individuals' abilities to engage in~     self-care, must be culturally appropriate, and must have components that overcome barriers~     faced by individuals living in Appalachia.~      The investigators propose a randomized, controlled comparative effectiveness trial with 300~     individuals from Appalachian Kentucky who do not have a primary care provider and who are at~     risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators~     will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction~     intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming~     barriers to success with (2) referral of patients to a primary care provider for management~     of their CVD risk factors. The investigators propose the following specific aims to be~     tested at 4 months and 1 year after baseline. To compare the short and long-term impact of~     the interventions on:~      1) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile,~     hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive~     symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3)~     quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and~     adoptability by assessing adherence to recommended CVD risk reduction measures, and~     retention of recruited individuals. The investigators hypothesize that in comparison to the~     referral strategy, the multifaceted patient-centered, self-care intervention will engender~     more favorable outcomes across all measures.~   "
89622|NCT01884233|"~     The objective of the current research is to improve treatment for injection opioid users by~     augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse~     prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.~   "
89623|NCT01884220|"~     The purpose of this study are: to characterize and understand the natural history of disease~     progression in WD and CESD, and to provide historical controls for WD and CESD for~     developing clinical treatment trials. The hypothesis is that the variability and clinical~     progression in WD and CESD is large and represents a continuum of severities from a lethal~     infantile to near normal adults with only fatty livers.~   "
89624|NCT01884207|"~     Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to~     differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of~     the orbit will be performed including standard morphological sequences and advanced sequence~     techniques. These advanced sequence techniques may allow to differentiate benign from~     malignant tumors based on their cellularity and vascularity (diffusion and perfusion~     imaging). These MRI data will be analysed and the level of diffusion and perfusion will be~     measured and compared to the histological findings. Cut-off values of diffusion and~     perfusion will be calculated that allow to separate benign from malignant tumors.~   "
89625|NCT01884194|"~     MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients~   "
89626|NCT01884181|"~     The hypotheses of the project are~        1. Diffusion MRI using compressed sensing could have reduced motion sensitivity and~          improved susceptibility related artifact because of accelerated acquisition.~        2. The macromolecule deposition in the brain of patients with Huntington Disease (HD) can~          lead to changes detectible by diffusion MRI.~      To validate the hypothesis that the new accelerated diffusion MRI technique could produce a~     new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion~     index will be calculated using accelerated acquisition. The diagnostic performance will be~     evaluated for data reconstructed with and without acceleration. The correlation with the~     disease severity will be assessed.~   "
89627|NCT01884168|"~     To investigate gene expression profile and immunological associated analysis relating to~     immunotherapy response of patients with malignant tumor presenting malignant cavity effusion~     after DC-CIK immunotherapy.~   "
89628|NCT01884155|"~     This open label trial is conducted to investigate the efficacy and safety of allogeneic~     umbilical cord blood (UCB) therapy for patients with stroke.~   "
89629|NCT01884142|"~     The investigators hypothesize that exercise training would improve the mechanoreflex and~     metaboreflex control in heart failure patients.~   "
89630|NCT01884129|"~     We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on~     CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.~   "
89631|NCT01884116|"~     Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and~     various treatment modalities have been introduced. If self-applicable physical modalities~     and medications that are used for treatment of MPS patients are combined, they may open up~     new possibilities for effective and practical self-care. The aim of this study is to~     compared the therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given~     in monotherapy and NSAID patch in combination with transcutaneous electric nerve~     stimulation, heating pad, or topical capsaicin in the treatment of patients with MPS of the~     upper trapezius.~   "
89632|NCT01884103|"~     Our overall goal in this proposed study is to describe the current prehospital trauma triage~     process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to~     identify the effect of certain medications (anticoagulants and platelet inhibitors) on~     TBI-related need for trauma center services, and to identify novel TBI screening strategies~     that are feasible for use in the prehospital setting.~   "
89633|NCT01884090|"~     The Youth Empowerment Solutions for Positive Youth Development (YES) Study , is a randomized~     controlled trial that compares youth in standard after school programs offering activity~     choice (e.g. sports, academic enrichment, arts) to youth assigned to an after school program~     that includes training in community development, formation of intergenerational partnerships~     and experience conducting community improvement projects. The study aims are to: 1)~     implement and evaluate an empirically developed intervention for empowering youth (YES)~     using a randomized controlled trial design in a high risk urban and suburban sample; 2) test~     a conceptual model that posits a causal relationship from youth empowerment processes to~     positive developmental outcomes; and 3) follow youth over time to assess sustainability of~     gains in healthy development. Developmental outcomes will be assessed at baseline,~     curriculum completion and at three and nine months post-intervention.~      This study will be referred to as the Genesee County Afterschool Study (GCAS) in~     recruitment, consents, assents and promotional materials. The study compares different types~     of after school programs, and we will be randomly assigning students into two groups, 1) the~     regular 21st Century Afterschool programs and 2) the regular 21st Century Afterschool~     programs with the YES supplement. We do not want to bias desirability of the random groups~     by naming one of the groups to be tested in the study name. Therefore, in documents we will~     refer to the study as the Genesee County Afterschool Study (GCAS).~      Study hypotheses:~        1. Youth in the YES intervention arm will demonstrate increased intrapersonal,~          interactional, and behavioral empowerment than youth in the comparison group arm.~        2. Youth in the YES intervention arm will demonstrate higher scores on the positive~          developmental outcome variables, and lower scores on the negative developmental outcome~          variables, than youth in the comparison group arm.~        3. Behavioral empowerment will partially mediate the relations between intrapersonal and~          interactional empowerment and youth developmental outcomes, such that youth with~          greater intrapersonal and interactional empowerment skills will demonstrate increased~          behavioral empowerment, which in turn will result in higher scores on positive~          developmental outcome variables, and lower scores on negative developmental outcome~          variables.~   "
89634|NCT01884077|"~     Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who~     undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of~     glenohumeral osteoarthritis.~      Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse~     Shoulder Arthroplasty.~   "
89635|NCT01884064|"~     This study investigated the short term effects of repeated administrations of~     repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate~     neurophysiologic responses to rTMS of the activated motor system in patients with FHD.~   "
89636|NCT01884051|"~     Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which~     underlie PAH will improve pulmonary vascular function and consequences of the disease.~   "
89637|NCT01884038|"~     Patients undergoing orthotopic liver transplant will experience some degree of clinical~     and/or biochemical hepatic dysfunction. This early injury is known as primary graft~     dysfunction and varies from minor abnormalities to primary nonfunction. Prostaglandin-class~     drugs, including prostacyclin and its analogs, could represent an important advance toward~     the goal of reducing transplant related morbidity, mortality and associated costs by~     providing these benefits.~   "
89638|NCT01884025|"~     Individuals with serious mental illness have greater morbidity from physical illness and~     mortality than the general population, but tend not to initiate or sustain engagement in~     health promotion interventions. Although promising weight management and wellness~     interventions have been developed for this population, they are very intensive and tend to~     have low enrollment, high attrition, and low reach. This pilot study will investigate a~     novel low-demand intervention that may be initially more acceptable, the Get Moving and Get~     Well! (GMGW) program. The primary objectives of the proposed study are to investigate the~     effects of participation in the GMGW program on measures of behavioral activation,~     self-efficacy, physical activity, general physical and mental health, mood, participants'~     intent to engage in more intensive physical health interventions, and actual engagement in~     those programs. Results of this pilot study will inform a future full-scale study of GMGW.~   "
89639|NCT01884012|"~     In this randomized-controlled, cross-over trial the investigators test the effect of~     long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases~     of 2 weeks on exercise performance and quality of life and many physiological parameters in~     patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.~   "
89640|NCT01883999|"~     The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized,~     multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE~     Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).~   "
89641|NCT01883986|"~     The aims of this project are to assess the feasibility of recruiting patients and delivering~     a nurse-led telephone based palliative care intervention for patients with newly diagnosed~     lung cancer and to assess if among patients with newly diagnosed lung cancer, the~     investigators can estimate the effect of a nurse-led telephone based palliative care~     intervention on quality-of-life, symptom burden and patient satisfaction.~   "
89642|NCT01883973|"~     Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain~     stimulation surgery in the awake patient using microelectrode recording to guide final~     electrode placement. Microelectrode recording is a means of analyzing the electrical~     activity of the brain, and assessing whether we have found the target for the deep brain~     stimulator electrode. However, no evidence exists that microelectrode recording improves~     patient outcomes. The use of microelectrode recording does extend the duration of surgery~     and there is evidence to suggest that microelectrode recording may increase the risk of~     bleeding in the brain during surgery.~   "
89643|NCT01883960|"~     The primary goal of this study is to establish and evaluate an image-based biomarker for the~     impaired motor control and sensory information processing present in Cerebral palsy (CP) and~     stroke patients.~   "
89644|NCT01883947|"~     The aim is to study effects of touch massage in the sub-acute phase after stroke in two main~     areas; general health and independence.The hypothesis are that; touch massage in the~     sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of~     life, decrease physiological stress responses, increase sensorimotor function, decrease~     disability, and increase activity in sensorimotor areas and decrease redundant brain~     activity in motor-related areas.~   "
89645|NCT01883934|"~     The purpose of this study is to improve patient understanding of and interest in donating~     frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility~     treatment.~   "
89695|NCT01883271|"~     Study objectives:~        1. To compare cardiovascular function in older compared to young healthy adults.~        2. To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate~          exercise on cardiovascular function in healthy older adults.~      Hypotheses:~        1. Compared to young adults, older adults will have lower cardiovascular function.~        2. Compared to continuous moderate intensity exercise training, interval training will be~          more effective in improving cardiovascular function in older adults.~   "
89646|NCT01883921|"~     Primary:~        -  Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™)~          using infusion nurse and patient measured physical, quality of life (QOL), respiratory,~          laboratory, and disability assessments in patients with Primary Immunodeficiency~          Disease (PIDD).~      Secondary:~        -  Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured~          outcomes.~        -  Change in IVIg/SCIg dose timing effects measured outcomes.~        -  Change in patient status is reflected in measured outcomes.~        -  Assess the value to physicians from collected outcomes data.~        -  Identify types of patients by response to IVIg/SCIg therapies (well maintained,~          problematic, etc.).~        -  Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease~          state, co-morbidities, and demographics.~   "
89647|NCT01883908|"~     Patients are asked to be in this study if have oropharyngeal cancer and will be treated with~     chemotherapy and radiation.~      This research is being done to find out if acupuncture can reduce the mouth inflammation and~     pain caused by chemotherapy and radiation. Chemoradiation may cause mouth inflammation and~     pain.~      Acupuncture is a medical technique of inserting very thin needles into the energy points~     on the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and joint pain. In this study we will assess the potential~     usefulness of acupuncture to decrease the severity of mucositis and mucositis-related mouth~     and throat pain in patients receiving chemoradiation for oropharyngeal cancer.~      Mouth cancer patients receiving chemoradiation who have not had acupuncture within the last~     one month and who do not have a history of head and neck cancer may join this pilot study.~   "
89648|NCT01883895|"~     The study involves recording response to discomfort following different forms of exercise.~     We think that there will be a increased pain tolerance following exercise but are unsure if~     there will be a difference between exercises.~   "
89649|NCT01883882|"~     The proposed research will develop, demonstrate the feasibility of, and pilot test in a~     randomized controlled trial a prescription opioid taper support intervention. This~     intervention aims to prevent opioid misuse and adverse events among patients receiving~     chronic opioid therapy for chronic non-cancer pain without evidence of current substance~     abuse.~      The project will yield information essential to planning a future, larger-scale RCT designed~     to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse,~     misuse, overdose and other adverse events among patients receiving chronic opioid therapy~     for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain~     related activity interference, and mood. Participants in our pilot study will be limited to~     those without current opioid abuse or other substance abuse, but past substance abuse will~     be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and~     overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients~     receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the~     opioid taper support intervention, as compared with patients randomized to usual opioid~     prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.~   "
89650|NCT01883869|"~     The hypothesis to be tested is that ticagrelor (Brilinta™) will reduce platelet activation~     and markers of inflammation in patients with pneumonia.~   "
89651|NCT01883856|"~     The purpose of this study is to evaluate and compare the clinical outcomes after~     implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the~     silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.~   "
89652|NCT01883843|"~     Stroke is one of the major causes of disability in the Western world. Initially gait is the~     most affected function, 80% of patients lose this ability.~      Rehabilitation in stroke patients improves walking abilities in terms of gait and related~     gait activities, though six months after stroke many patients are significantly disabled.~      Recently, a prospective study of 205 stroke patients showed that approximately 21% of~     patients have a significant decrease of mobility between the first and the third year after~     stroke. The main finding showed that inactivity was the most important factor for the~     mobility decline.~      Evidence about effects of direct current brain stimulation on motor recovery function of~     lower limb are still little, some show that quadriceps strength after stimulation of damaged~     M1 area increased. Another study where tDCS was associated with robotic gait training did~     not report any effect compared to treatment alone. It is necessary to define if a different~     dosage of stimulation or the association of tDCS with gait training can improve walking and~     if further studies are required to investigate their effectiveness.~      The aim of this clinical trial is to test the possibility of gait improvement through the~     association of tDCS with a specific task-oriented circuit training for walking abilities,~     balance and mobility.~   "
89653|NCT01883830|"~     Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000~     hospitalizations every year. Functional consequences of an acquired brain injury have a~     considerable impact on quality of lives of patients and care-givers with direct effects on~     balance, mobility and on psycho-social functions. Attention deficits are one of the most~     frequent and disabling consequences of severe brain injury. Within the wide spectrum of~     attentive problems, patients with traumatic brain injury frequently have shown difficulties~     in divided attention. Patients, care-givers and professionals frequently refer difficulties~     also in selective attention and vigilance as consequence of the trauma. It has been shown~     how these difficulties are tightly related with the missed return to work after two years~     from the injury.~      The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol~     on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of~     falling, attentive functions (selective and divided attention) in subjects which have had a~     traumatic brain injury at least 12 months before.~   "
89654|NCT01883817|"~     The study hypothesis is that DHA is more effective than placebo in increasing brain~     activation and reducing symptoms in psychostimulant-free children with ADHD.~   "
89696|NCT01883258|"~     The study objectives are:~        1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.~        2. To compare the effect of 8 weeks of aerobic interval training versus continuous~          moderate exercise on cardiovascular function in adults with type 2 diabetes.~        3. To examine the mechanisms underlying the exercise-related changes in cardiovascular~          function.~      The investigators hypothesize that compared to continuous moderate intensity exercise~     training, interval training will be more effective in improving cardiovascular function in~     adults with type 2 diabetes.~   "
89655|NCT01883804|"~     Type 1 Diabetes is an autoimmune condition in which segments of the immune system cause the~     destruction of insulin producing cells in the pancreas, leaving individuals with an impaired~     ability to control blood glucose levels. Currently there is no cure for Type 1 Diabetes and~     the treatments involve lifelong insulin administration and careful monitoring of blood~     glucose levels. Long-term complications like cardiovascular disease, nerve damage, and~     retina damage, may result. Previous studies have shown that improvement in the control of~     blood glucose can reduce the risks from these long-term complications. Residual insulin~     production, typically within the first few years following diagnosis, helps to reduce an~     individual's need to supplement insulin by injection or pump. This effect helps in~     maintaining the body's ability to regulate blood glucose levels and reducing the needs of~     external insulin.~      Methyldopa, or Aldomet, has been approved by the Food and Drug Administration and is~     commonly used to treat high blood pressure. This drug has been approved for several decades~     and has been shown to be safe and effective. This drug has been identified by the researcher~     to be able to block the communication between two important types of immune cells; which~     play a critical role in the autoimmune processes of Type 1 Diabetes. The investigators~     hypothesize that Methyldopa, over a 6 week treatment period, will block this communication~     and possibly slow down the destruction of insulin producing cells. The investigators hope to~     assess the appropriate and safe dose to achieve this effect, along with the drug's ability~     to maintain insulin production and blood glucose control.~   "
89656|NCT01883791|"~     An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol~     and/or drug use. One model of intervention that has been shown effective in medical settings~     to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief~     intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for~     risky alcohol use in medical settings, there has been no research on the effectiveness of~     SBIRT in mental health treatment settings. Given the proportionately large number of mental~     health patients who also engage in hazardous substance use, research is needed to find an~     appropriate and effective substance use intervention for patients in these settings.~      The proposed study uses a randomized controlled trial to examine the extent to which the~     World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance~     Involvement Screening Test) and its associated brief behavioral intervention, leads to~     reductions in substances prevalent in mental health settings: alcohol, cannabis and~     stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of~     SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose~     level of substance misuse indicates a need for treatment, initiation and engagement into SUD~     treatment services. Eligible participants will be mental health patients who report any past~     year use of cannabis or stimulants or at least one heavy drinking day in the past year.~     Mental health patients (n =1,080) who meet eligibility criteria will be enrolled and~     randomly assigned to either the SBIRT intervention condition or to a health education~     attention control condition. Participants will be assessed at baseline on substance use,~     psychiatric symptoms and quality of life. Each participant will be assessed at 3-, 6- and~     12- month follow up points for alcohol and drug use, involvement in SUD treatment services,~     severity of psychiatric symptoms and quality of life. If successful this study will yield~     valuable new knowledge about the effectiveness of SBIRT in mental health treatment settings~     and will promote improved well being of mental health patients. Further, the study will~     provide evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from~     this research will be used as the basis for broader dissemination and of SBIRT in mental~     health settings.~   "
89657|NCT01883778|"~     The purpose of this study is to identify existing cost knowledge of Emergency Medicine (EM)~     physicians and patients and investigates its reported impacts on medical compliance. A~     cross-sectional survey will be administered electronically to Emergency Medicine physicians~     at the University of Utah Hospital and the Emergency Physician Integrated Care, LLC (EPIC)~     who staff ten-community hospital Emergency Departments (ED) in order to investigate~     physician knowledge and attitudes regarding cost and perceived patient compliance. In~     addition, a cross-sectional survey will be administered to a convenience sample of patients~     presenting to the University of Utah Emergency Department to obtain information about their~     cost knowledge and reported compliance. All ED patients will complete a follow-up phone~     survey to measure compliance with recommendations made during the ED visits. Following~     administration of the baseline survey physicians will be provided the prices of the test and~     procedures and will be re-surveyed 30-days later as a post intervention test to measure~     changes in knowledge and attitudes.~   "
89658|NCT01883765|"~     Neurofeedback training (NFT) has been frequently investigated as an alternative treatment~     for ADHD mainly in children and adolescents. However, randomized double-blind trials that~     include a sham-neurofeedback control group are lacking, as well as studies examining the~     efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is~     crucial to monitor and exclude unspecific effects.~      This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition~     and a cognitive behavioral treatment in adults with persistent ADHD.~      Efficacy is assessed on several outcome parameters, such as symptom severity,~     neuropsychological variables (e.g., attention, memory), and event related potentials in the~     EEG.~   "
89659|NCT01883752|"~     The purpose of this study is to evaluate whether goal directed fluid management using~     respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has~     potential to decrease postoperative complications and outcomes.~   "
89660|NCT01883739|"~     The investigators shall conduct a randomized controlled trial to investigate the effect of~     parental presence at transfer rounds on parental anxiety and patient safety following~     transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The~     investigators plan to test the hypothesis that parental involvement in the child's transfer,~     with the option of peer support, will result in measurable reductions in medication errors,~     unplanned nutritional and feeding management, and parental anxiety after transfer as~     compared to the control group. The investigators goal is to improve continuity of care by~     implementing multidisciplinary transfer rounds at the child's bedside in which patients and~     family share in the control of the management plan when a cardiac child is discharged from~     PCICU to the ward.~   "
89661|NCT01883726|"~     Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang~     Gung Memorial Hospital. The objective of this study is to compare the number of clinical~     visits, total prices, complications and nasal symmetry between these two NAM reconstruction~     methods.~   "
89662|NCT01883713|"~     Acute and chronic anemia continue to be associated with increased mortality in a number of~     clinical settings, including cardiac and non-cardiac surgery. However, We have no clinical~     measures that let us know of impending insufficient oxygenation as anemia progresses (R.B.~     Weiskopf). The current proposal is based on experimental and clinical data which suggest~     that plasma methemoglobin (MetHb) may be a sensitive biomarker of tissue hypoxia and anemic~     stress in surgical patients.~      Hypothesis: Increased methemoglobin is a biomarker of tissue hypoxia during acute anemia.~      Primary Objective: To demonstrate a direct relationship between decreased Hb and increased~     MetHb in patients undergoing acute hemodilution on cardiopulmonary bypass (CPB).~   "
89663|NCT01883700|"~     This study examines the effects of carbohydrate type (high- or low-Glycemic Index (GI)) and~     amount (high- or low-Glycemic Load (GL)) have on blood glucose levels, blood pressure and~     arterial stiffness in healthy individuals. It will also determine whether subjective ratings~     such as test meal palatability and hunger are related to changes in blood glucose. The~     investigators hypothesize that: (1) High-GI meals, regardless of GL, will increase arterial~     stiffness; low-GI meals, regardless of GL, will have a neutral or lowering effect on~     arterial stiffness (augmentation index). (2) High-GI meals, regardless of GL, will have an~     elevating effect on both central and peripheral blood pressures. (3) The incremental area~     under the curve for blood glucose will show most significant differences between high-GI,~     high-GL and low-GI, low-GL meals at 30 and 90 min.~   "
89664|NCT01883687|"~     Objectives: The aims of this study are (1) to define the effectiveness of functional nasal~     surgery during Le Fort I osteotomy on nasal obstruction through objective as well as~     subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery~     with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal~     surgery may reduce nasal obstruction severity.~      Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial~     Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients~     with unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for~     males; 40 in experimental and 40 in control groups) Interventions: In the experimental~     group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group,~     all patients will receive Le Fort I osteotomy only.~      Measurements: All patients will undergo history taking, clinical examination,~     radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image~     examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce~     radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and~     24 months after surgery.~      Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated~     measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for~     a p value of less than 0.05.~      Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty,~     effectiveness~   "
89665|NCT01883674|"~     This project evaluates the use of different types of proteins from various food sources~     after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who~     have low muscle mass). Specifically, researchers want to:~        -  Examine the efficiency of protein intake after exercise on muscle mass and physical~          abilities;~        -  Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL~          cholesterol, total cholesterol and triglycerides);~        -  Examine the impact of exercise and proteins on liver enzymes;~        -  Examine the impact of exercise and proteins on a hormone that controls hunger;~        -  Evaluate the program's impact on the ability of the body to produce energy.~      All participants are exercising (resistance training) and ingest one of the 3 different~     sources of proteins, immediately after training:~        -  Milk proteins (from milk beverage)~        -  Essential amino acids (added to a soya beverage)~        -  No protein (rice beverage - control group)~      Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical~     function equivalent to the essential amino acids (EAA). We anticipate that both milk~     proteins and EAA will be both superior to control group.~      This would represent an interesting finding since milk is more accessible, palatable and~     cheaper than essential amino acids commercial mix.~   "
89666|NCT01883661|"~     The aim of this study is to prove the BMMNC Therapy in Multiple sclerosis, and to control~     symptoms and help to maintain a normal quality of life of suffering patients.~   "
89667|NCT01883648|"~     This is a randomized, cross over study to determine the efficacy of coconut oil in subjects~     with mild to moderate Alzheimer's disease.~   "
89668|NCT01883635|"~     The purpose of the study is to see whether exercise can improve the health and well-being of~     cancer survivors. We also want to know about the health and well being of caregivers.~   "
89669|NCT01883622|"~     Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of~     glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are~     available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV~     in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes~     (GDM), and its possible association with HbA1c.~   "
89670|NCT01883609|"~     This is a clinical trial in which healthy volunteers will be administered experimental~     malaria vaccines. One group of volunteers will receive vaccination with the leading malaria~     vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01~     with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints).~     Another group will receive a vaccination schedule composed of the same dosage and timing~     regimen of RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after~     the first RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week~     timepoints).~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples. Volunteers will be~     infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition,~     a group of volunteers not receiving vaccines will also be infected with malaria by the same~     method. These infection experiments will be used to assess vaccine efficacy: how well the~     vaccines act to prevent malaria disease. A further single volunteer may also be infected~     with malaria; this volunteer participated in a previous trial where they received vaccines~     and was completely protected against malaria disease after infection by mosquito bite.~      The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63~     ME-TRAP and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from~     viruses which are modified so that they can not multiply. The viruses have extra DNA in them~     so that after injection, the body makes malaria proteins (but malaria does not develop), so~     that the immune system builds a response to malaria without having been infected by it.~      Healthy volunteers will be recruited in England at three research sites: in Oxford, London~     and Southampton.~   "
89671|NCT01883596|"~     To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with~     placebo to prevent ventilator associated pneumonia in children admitted to a pediatric~     critical care unit.~   "
89672|NCT01883583|"~     To check the possibility of the acquisition of a number of parameters through real-time~     contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with~     pathologic results from ultrasound guided biopsy of transplanted kidney~   "
89717|NCT01882985|"~     This phase II trial is studying how well giving docetaxel together with lycopene works in~     treating patients with hormone-resistant prostate cancer not previously treated with~     chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming.~     Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.~   "
89673|NCT01883570|"~     Currently, teaching X-ray interpretation to medical students is not standardized, and is~     generally not very effective.~      Objective: The goal of our study is to evaluate whether directly teaching an expert search~     strategy for x-ray interpretation to 3d year medical students is effective.~      Methods:~        -  An expert's visual search strategy was recorded using a gaze-tracking device. The~          search strategy was then reproduced using a dynamic cursor moving across the~          corresponding chest x-ray, and incorporated into a teaching program accessible via the~          internet.~        -  Participants are 3rd year medical students who will be randomized into two groups. The~          experimental group will have access to the teaching program as described. The control~          group will have access to the same x-rays but not the expert's search strategy.~        -  At the end of the study period the investigators will collect performance data (the~          participants' accuracy at reading a series of chest x-rays) and process data (using~          gaze-tracking to evaluate the participants' search strategies); the experimental and~          control groups will be compared.~      Expected results:~      The investigators expect the group trained in expert search strategy to show improved~     accuracy at reading chest x-rays, and an improvement in their visual search strategy~   "
89674|NCT01883544|"~     The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and~     female subjects.~   "
89675|NCT01883531|"~     It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement~     in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks~     of trial treatment compared to treatment with inhaled placebo b.d.~      Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a~     threshold of 3% for the purposes of determining an appropriate sample size for statistical~     power whilst retaining trial feasibility in an orphan disease population.~   "
89676|NCT01883518|"~     The purpose of this study is to achieving a six-month progression free survival (PFS) of~     patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor~     lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas~   "
89677|NCT01883505|"~     This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD)~     subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor~     fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa~     pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory~     drug delivery pump following repeated dosing of ND0612 in a conventional home setting in~     Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa~     and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored~     in subjects with PD and motor fluctuations.~   "
89678|NCT01883492|"~     The primary objectives of this clinical study include:~        -  Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who~          received Total Hip Arthroplasty with E1~        -  Compare E1 wear used with CoCr and Biolox Delta heads~   "
89679|NCT01883479|"~     The purpose of this study is to examine the efficacy of the active interventions (exercise~     or wellness/support intervention) compared to usual care on the prevention of postpartum~     depression among women at risk for depression. The investigators will also examine the~     efficacy of an exercise intervention compared to a wellness/support intervention on~     postpartum depressive symptoms among women at risk for depression.~   "
89680|NCT01883466|"~     Urban air pollution is a major contributor to greenhouse gases and has been shown to~     increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel~     marketing and research, with biodiesel emerging as one of the strongest contenders within~     international markets. The pursuit of alternative renewable fuels is incredibly complex and~     has powered research in agriculture, biotechnology, production, transportation, feedstocks,~     ecology and biomass manufacturing. In spite of this, health effects have been an almost~     completely overlooked aspect. The purpose of this study is to investigate whether 100%~     biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory~     responses. Further investigations into the chemical composition of biodiesel exhaust will~     also be performed.~   "
89681|NCT01883453|"~     Healthy persons are invited to participate in the study and are given a home protocol~     (WURSS21), nasal spray and a sample pin. The included persons are told to make a~     nasopharyngeal sampling from the nose when they are sure that they have caught a common~     cold. After the sampling they start to spray and also fill in the records daily. The aim of~     the study is to investigate whether a nasal spray with glucose oxidase could shorten an~     episode of common cold.~   "
89682|NCT01883440|"~     Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey.~     Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in~     laboratory studies.~      In the present study we aim to investigate if a nasal spray with glucose oxidase could treat~     a common cold, when the treatment is started even after the onset of the symptoms. The study~     is randomized and placebo controlled.~   "
89683|NCT01883427|"~     To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper~     respiratory tract infections in children beyond 4 years.~   "
89684|NCT01883414|"~     Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on~     one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after~     treatment. Study images will be obtained before treatment, immediately after treatment and~     at each follow-up visit.~   "
89718|NCT01882972|"~     Despite a robust literature on the benefits of exercise for cancer survivors, most of the~     research to date falls in two primary areas - aerobic exercise and breast cancer survivors.~     The focus on aerobic training alone is a concern as resistance training is critical for~     building the muscle mass necessary to maintain physical function. However, concerns have~     been raised about the potential for higher than tolerated adverse event rates during~     resistance training, particularly that which is unsupervised, despite a history of safe use~     of resistance training in other chronically diseased patient populations. The aim of this~     pilot study is to demonstrate the feasibility, safety and quality of life benefit of a~     home-based resistance-training program among colorectal cancer survivors. The investigators~     will recruit n=30 men and women with stage I-III colon cancer. Participants will be~     randomized to a home-based exercise intervention that combines aerobic and resistance~     exercise. Control arm participants will receive a home-based meditation program.~   "
89685|NCT01883401|"~     Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia~     while no such studies with whole strawberries have been reported in the US population. The~     investigators propose to examine the effects of low and high doses of freeze-dried~     strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress~     and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal~     adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly~     assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber~     and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2~     cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12~     weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at~     screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry~     intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid~     profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid~     particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL,~     myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin,~     interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5%~     significance level. We anticipate a dose response effect in decrease in lipids, oxidative~     stress or inflammation following strawberry intervention versus controls.~   "
89686|NCT01883388|"~     NovellusDx early detection test is a simple to perform blood test, which identifies the~     deregulated signaling pathways within the patient tumor based on protein secretion to the~     blood, thus enabling early stage disease signature detection. The investigators' current~     clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test-~     discriminating between cancer patients and healthy subjects.~   "
89687|NCT01883375|"~     Dying patients and their families face many challenges near the end-of-life. Not only do~     patients often experience physical distress, but they also have feelings of loss of dignity,~     isolation, and uncertainty. Family members also face many challenges. They bear witness to~     the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense~     of helplessness.~      The purpose of this study is to introduce and evaluate a new intervention called Dignity~     Talk, meant to enhance end-of-life experience for both patients and their families. Dignity~     Talk is based on a set of questions by which terminally ill patients and their family~     members can engage in meaningful conversations with each other. It is intended to lessen~     feelings of loss and helplessness and enhance feelings of connectedness by facilitating~     conversations that tap into a sense of meaning and purpose, sharing of memories, wishes,~     hopes, and giving guidance to those who will soon be left behind.~      In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk~     question framework (is it easy to understand, do the investigators have the right questions,~     and is the wording sensitive). In Phase 2 of the study the investigators will ask 100~     patient-family pairs for feedback about Dignity Talk: what influence it had on their~     palliative care experience, whether it works well, and whether this intervention should~     become a regular part of palliative care. The investigators will also ask for feedback from~     health-care providers in both phases. Four to six months after the death of their loved one,~     the investigators will contact the family member to ask their thoughts about Dignity Talk,~     how it shaped their experience of their grief and bereavement.~      The investigators expect that the study will show that Dignity Talk can be an effective,~     highly accessible palliative care intervention, which will enhance the end-of-life~     experience for palliative patients and the families who support them.~   "
89688|NCT01883362|"~     To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy~     reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem~     cell transplant,~   "
89689|NCT01883349|"~     The purpose of this study is to understand cognitive impairment in end stage renal disease~     before and after a kidney transplant.~   "
89690|NCT01883336|"~     This study intends to investigate the long term follow-up of small non-inflammatory~     pancreatic cysts.~   "
89691|NCT01883323|"~     This is a phase II clinical study for patients with metastatic (the cancer has spread to~     other parts of the body) melanoma. Patients will receive an infusion (given by vein) of~     autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that~     recognizes tumor cells and enter them which causes the tumor cells to break down.~      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and~     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will~     receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This~     study will see how useful this regimen is in treating metastatic melanoma.~   "
89692|NCT01883310|"~     Aims of the study:~      This is a double-blind randomized-controlled trial to test the effects of a task oriented~     training combined with cerebellar transcranial direct current stimulation on locomotor~     function, mobility and balance in multiple sclerosis subjects with moderate gait impairments~     (EDSS 4-5,5).~      Subjects and methods: 30 multiple sclerosis patients will be recruited in an outpatient~     rehabilitation clinic University Hospital Ferrara. Informed consent will be obtained.~     Participants enrolled will included in 2 different treatment groups: Task Oriented Circuit~     Training (TOCT) + anodal cerebellar transcranial direct current stimulation (experimental~     group) and TOCT + sham transcranial direct current stimulation over the cerebellum (control~     group). The group with anodal transcranial direct current stimulation will receive~     continuous stimulation with intensity of 2 mA during the first 15 minutes of functional~     circuit training. In the sham session, anodal transcranial direct current stimulation was~     applied for 30 s and then shut off. Each subject will receive 10 task-oriented training~     sessions over 2 weeks (5 sessions/week). 3 subjects with a supervisor physiotherapist will~     take part at the TOCT. During the stimulation sessions both the subject and the researcher,~     responsible for carrying out clinical tests, will be unaware of the type of stimulation set.~      Treatment efficacy outcome measures will be clinical test for gait speed (Timed 25-Foot~     Walk), walking endurance (six minute walking test), balance (Dynamic Gait Index) and~     mobility (Time Up and Go Test); self-assessment questionnaire for motor fatigue (Fatigue~     Severity Scale FSS) and quality of life (Short Form (36) Health Survey).~      Outcome measures will be assessed the week prior to treatment initiation (T0), the week~     after the end of treatment (T1) and at 3 months follow-up (T3) to evaluate treatments~     retention, by a clinician blinded to the treatment. At the end of each session, the subject~     will complete a questionnaire where report side effects due to stimulation (headache, neck~     pain, burning, redness and/or itching in the site of stimulation).~   "
89693|NCT01883297|"~     This is a phase I clinical study for patients with platinum resistant (does not respond to~     platinum-based chemotherapy) high grade serous ovarian, fallopian tube, or primary~     peritoneal cancer. Prior to the main treatment, patients will receive cyclophosphamide by~     vein. Patients will then receive an infusion (given by vein) of autologous~     tumor-infiltrating lymphocytes (TILs) which will first be taken from the patient, then be~     stimulated with certain substances called autologous dendritic cells (DCs) and OKT3~     (anti-CD3 antibody), and then given back to the patient as an infusion. This is believed to~     make the TILs work better. TILs are a type of white blood cells that recognizes tumor cells~     and enter them which causes the tumor cells to break down. After infusion of TILs, low-dose~     interleukin-2 (IL-2) therapy will be given.~   "
89694|NCT01883284|"~     Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of~     epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers~     effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors~     (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using~     an air-liquide interface culture of nasals cells from CF patients or controls.~   "
89697|NCT01883245|"~     Patients affected by chronic orofacial pain represent an emergent medical problem due to the~     lack of knowledge on the cause, pathophysiology and psychology of many of these conditions,~     that belongs to a multifactorial origin.~      Particularly, temporomandibular joint disorders involve a series of symptoms that refers~     both to intrinsic and extrinsic joint conditions where pain can be associated to a reduction~     of the joint movement, click or to other sounds of the joint.~      The lack of a recognized causal therapy led to the suggestion of many treatment modalities~     with a multidisciplinary approach for the management of symptoms that include the use of~     occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs,~     chirurgical approaches. In most cases these strategies together allow the control of the~     symptoms, even though they aren't completely resolutive.~      In these patients is frequent chronic pain and ineffectiveness of common drugs used.~      It has been demonstrated how transcranial electrical brain stimulation with direct current~     (tDCS) is able to reduce the intensity and the duration of chronic pain.~      Stimulating the motor cortex can reduce pain by modulating brain activities in the areas~     involved in cerebral circuits controlling pain, such as thalamus, facilitating the~     descendant inhibitory mechanisms and enhancing the number of opiates receptors.~      This clinical trial is based on the evaluation of the effects of tDCS on pain and on~     activities daily living (ADL) participation patients with chronic orofacial pain that don't~     respond to other treatments.~   "
89698|NCT01883232|"~     As a dentist, administering anesthetic to patients, especially children, proves to be one of~     the most difficult parts of a procedure. Pain is one of the most common symptom in~     dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection~     has several causes. Of the many reasons for pain at the site of injection, the acidity of~     the solution is thought to be most important. This study will be measuring the effects of~     adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is~     commonly used in medical applications but is not widely used in the dental setting. Using~     this biochemistry and human physiology, one can predict when buffering the lidocaine~     injection, a quicker response in analgesia and a decrease in pain during administration. I~     will be measuring the effect using several measuring devices to gauge if buffering the local~     anesthetic will benefit the pediatric dental patient by reducing the time it takes for the~     analgesic effect as well as decreasing the pain during administration. Along with time, I~     will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for~     assessing pain in the pediatric population. The pediatric dental population has aversions to~     dental procedures because of the associated pain produced from most procedures. If limiting~     the time it takes for the analgesic to take effect and decrease the pain altogether, the~     pediatric patient will be less likely to skip treatment therefore, increase dental health.~   "
89699|NCT01883219|"~     The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI)~     therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive~     acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell~     transplantation(allo-HSCT).~   "
89700|NCT01883206|"~     The purpose of this study is to see how well the antibody levels found months to years after~     patients entered a previous randomised placebo-controlled trial of a glycoprotein B vaccine~     against cytomegalovirus have persisted and to have the previous samples retested using~     different methods which have been further developed in different laboratories.~      Also, to prepare monoclonal antibodies from the B lymphocytes of these patients and define~     their strength. If potent antibodies are identified, the investigators would like to~     consider developing them further to see if they can protect future transplant patients~     against cytomegalovirus.~   "
89701|NCT01883193|"~     Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain~     the benefits of ensuring optimal maternal nutrition before conception and providing an~     evidence base for programmatic priority directed to minimizing the risk of malnutrition in~     all females of reproductive age.~   "
89702|NCT01883180|"~     The purpose of this study is to compare the incidences of GVHD and viral infections in~     haploidentical hematopoietic stem cell transplant recipients receiving different dose of~     antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our~     first objective was to investigate the optimal dose of ATG for aGVHD and second object was~     to evaluate the effect of different dose of ATG on post-transplant viral infection.~   "
89703|NCT01883167|"~     This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD)~     interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor~     RDEA3170 and provide information for potential future clinical studies using this~     combination. Combination treatment using 2 drugs with different mechanisms of action may~     achieve improved response and may allow the use of lower doses, resulting in fewer side~     effects than the use of either drug alone.~   "
89704|NCT01883154|"~     Genetic and environmental factors are believed to play a major role in intrauterine growth~     and intrauterine programming. We intend to study genetic factors such as Telomere~     homeostasis, senescence, genomic instability and the presence of Genomic copy number~     variations in placental tissue from pregnancies complicated with Intrauterine growth~     restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies~     and from normal pregnancies. We also intend to assess these factors in cord blood and~     maternal blood.~   "
89705|NCT01883141|"~     The purpose of the iSPOT Study is to evaluate the contractility using positive left~     ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac~     resynchronization therapy (CRT).~   "
89719|NCT01882959|"~     The meta-analysis of data obtained from randomized controlled trial on effectiveness of~     radiofrequency denervation on reducing chronic neck and low back pain.~   "
89720|NCT01882946|"~     The study comprises a Phase I component during which the optimal dose of DCVax-Direct for~     the treatment of solid tissue tumors will be identified, followed by a Phase II component to~     determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability~     to reduce tumor growth.~   "
89795|NCT01881958|"~     Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of~     the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder~     containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down~     beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.~      The objective of the study is to assess the efficacy and safety of administrating DiaPep277®~     in type 1 diabetes patients.~   "
89706|NCT01883128|"~     Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four~     men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment~     which has significant side effects. Few men are offered a further treatment such as surgery,~     HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators~     believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately~     detect whether cancer has come back inside or outside of the prostate or both. Also~     radiotherapy damages tissue surrounding the prostate which affects tissue healing for~     example after surgery. Treating just the cancer in the prostate only (focal treatment)~     rather than the whole prostate may limit this damage and cause fewer side-effects. The~     investigators want to see if new imaging tests can better identify cancer that has spread~     outside of the prostate and areas of cancer inside the prostate. Our new tests are~     whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease).~     First, the investigators will compare the results of whole-body MRI to existing imaging~     tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the~     investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of~     the prostate called template prostate mapping which will show us where and how aggressive~     the cancer is. Third, if the cancer is confined to the prostate, the investigators will~     treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that~     these new imaging tests could better identify those who will benefit from early hormone~     treatment and those who will benefit from local salvage treatment. Our study may help~     justify carrying out a larger trial looking at how good the treatment is in controlling~     cancer in the medium and long-term.~   "
89707|NCT01883115|"~     Our recent prospective randomized controlled study comparing single-port vs. multiport~     laparoscopic total extraperitoneal inguinal herniorraphy (NCT 01660048) demonstrated~     superiority of the single-port technique in reducing post-op pain/analgesic requirements,~     quicker return to work/normal physical activities and improved cosmetic scar scores. During~     this study all patients underwent the initial extraperitoneal dissection with the distension~     balloon. However, the balloon itself costs AU $380 per device which represents a significant~     percentage of the overall cost of the procedure (when the hospital/operating rooms cost is~     approximately AU $2500 for a unilateral laparoscopic inguinal hernia repair) especially if~     only unilateral inguinal herniorraphy is performed.~      The European Hernia Society Guidelines encourage the use of the distension balloon for the~     initial distension/dissection of the extraperitoneal space especially during the learning~     curve. This recommendation arises from the fact that during the conventional multiport~     repair the umbilical port allows only the insertion of the laparoscope and the~     extraperitoneal space cannot easily be dissected with the scope itself, especially in~     patients with well-developed linea alba extending down to the pubic symphysis, and the~     camera itself, if used as dissection device, would become smudged and it would have to be~     repeatedly withdrawn for cleaning. Yet this must occur since the extraperitoneal space must~     be dissected in the midline sufficiently for safe insertion of two additional 5 mm ports for~     insertion of dissecting instruments in order to complete the extraperitoneal space~     dissection and the repair.~      With single incision laparoscopic surgery the use of the Triport™ system ensure that the~     port can be place under direct vision into the extraperitoneal space when the scope and two~     dissecting instruments can be safely inserted at the outset. In this way the extraperitoneal~     space can be dissected under direct vision. The balloon dissection is essentially a blind~     dissection even though the balloon distension is being observed by the scope, incorrect~     tissue planes can be entered ie the dissection can occur below the pre-peritoneal fascia~     exposing the nerves in the groin with the potential risks for nerve damage and entrapment.~     This is an argument that surgeons who practise transabdominal preperitoneal inguinal hernia~     repair use to justify their superior technique over the TEP repair because, in the TAPP~     repair, the peritoneum is carefully dissected free from and leaving the underlying~     preperitoneal fascia intact.~      While the use of the balloon, when some 25 pumps of air are used during the insufflation,~     to create a significant space to place not only the two 5 mm ports but also to create a~     significant extraperitoneal dissection when usually only the lateral space and the hernia~     sac need to be dissected this is not always possible. In patients who have had previous~     lower abdominal surgery including previous anterior inguinal herniorraphy (especially if the~     mesh plug is used) the balloon dissention is normally judicious as one cannot predict~     whether there are any significant peritoneal or even bowel adhesions. Consequently, in such~     cases, the balloon distension is normally confined to an area just inferior to the umbilical~     port and superior to the pubic symphysis so that there is just enough extraperitoneal~     dissection to place the two 5 mm trocars. Usually this means only using only 5 pumps of air~     in the distension balloon for placement of two 5 mm trocars. Then the dissection of the~     extraperitonealy space under direct vision can take place. The use of the distension balloon~     in such cases represents an enormous waste of resources since AU $380 is spent just to~     create enough space to place the two 5 mm ports and hence allowing the insertion of the~     dissecting instruments. With the Triport+™ port the dissecting instruments can easily be~     placed in the extraperitoneal space and the dissection can begin under direct vision hence~     achieving the same safe dissection that TAPP surgeons claim to perform.~      In this study we aim to look at the safety and efficacy of telescopic vs. balloon dissection~     by prospectively comparing a similar former group of patients to the ones who had previously~     undergone single-port inguinal herniorraphy with balloon dissection in our previous study~     (NCT 01660048).~      All patients having surgical treatment of groin hernia at St Luke's and Holroyd Private~     Hospitals are subject to very careful assessment and study. All patients are requested to~     report immediately if there are any problems.~   "
89708|NCT01883102|"~     This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the~     body; counts of which are used to determine a disease of nerves called small nerve fiber~     neuropathy.~      Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1%~     capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such~     ablation results in relief of spontaneous pain, touch, or heat-pain.~   "
89709|NCT01883089|"~     The current study combines both clinical trial and daily process methodology to examine the~     dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e.,~     craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior~     to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily~     avoidance inclinations will significantly moderate the effect of daily approach inclinations~     on drinking behaviors, and that significant increases in avoidance inclinations will be~     observed prior to treatment entry, followed by significant decreases in approach~     inclinations during treatment.~   "
89710|NCT01883076|"~     This is a Phase I study to determine the safety and feasibility of injections of autologous~     umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome~     (HLHS) children undergoing a scheduled Glenn surgical procedure.~      The investigators are doing this research study to find out if autologous stem cells from~     the individual's own umbilical cord blood can be used to strengthen the muscle of the right~     side of their heart. This will help determine the safety and feasibility of using cell-based~     regenerative therapy as an additional treatment for the management of HLHS.~   "
89711|NCT01883063|"~     This is a prospective multi-site study. Subjects with distal radius fractures will be~     enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed~     non-operatively with a splint or cast. Subjects will be enrolled in each group according to~     physician's standard of care (either casting/splinting or surgery) for distal radius~     fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with~     a final qualifying decision made by a group of three independent adjudicators. The final~     qualifying review should allow for similar patient groups within each arm of the study due~     to the variability that can arise in fracture classification. Review by the adjudicators~     should be completed within 1 week.~   "
89712|NCT01883050|"~     Patients who recently suffered a heart attack will use a smart-phone/computer application~     during cardiac rehabilitation to reduce their risk of a future attack, their~     re-hospitalizations, their cost of care, and increase their quality of life.~   "
89713|NCT01883037|"~     There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue~     glucose 201 RT system with the laboratory gold standard.~      The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as~     patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have~     CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and~     nutritional status, both of which increase mortality.~      The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the~     Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve~     years should be screened annually.~      The World Health Organisation has pointed out that due to the absence of a more specific~     biological marker to define diabetes, plasma glucose estimation remains the basis of~     diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method~     for measuring and reporting glucose concentration in blood. However, it has also recognised~     that there is a widespread use of capillary sampling. Although fasting values for venous and~     capillary plasma glucose are the same, in the nonfasting state capillary samples will give~     higher results than venous samples, and glucose values require conversion which can be~     problematic.~      HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory~     quality test results at the point of care for the diagnosis, screening and monitoring of~     diabetes mellitus. The analyzer is easy to use and the system can be operated by~     nonlaboratory personnel, also the results can be presented immediately, leading to~     significant time and resource saving. The patient also benefits from having the result~     immediately instead of waiting for several hours. With immediate result, the doctor and~     health care professionals can provide education, support and reassurance, and implement care~     plans, if appropriate, at the earliest opportunity.~      The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the~     laboratory standard method in the analysis of blood glucose concentration during oral~     glucose tolerance test.~   "
89714|NCT01883024|"~     The purpose of the study is to assess the relevance of the advices provided by the IPRA©~     smartphone application for guiding the responses of insulin pump treated type 1 diabetes~     patients using real-time continuous glucose monitoring.~   "
89715|NCT01883011|"~     The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment~     on the aphasic status of subjects suffering from aphasia after acute ischemic middle~     cerebral artery stroke and having received their medication within 7 h post-stroke onset.~   "
89716|NCT01882998|"~     This study aims to test the effectiveness of a behavioral intervention aimed at preventing~     the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East~     Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation~     are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk~     of acquiring HIV and dying.~      Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important~     component of the global World Health Organization (WHO) strategy to eliminate~     mother-to-child transmission of HIV but there has been no study to date to assess~     interventions that can effectively keep these women uninfected.~      In this study, the investigators will test the hypotheses that:~        1. extended repeat HIV testing and enhanced counseling (ERHTEC) during late pregnancy (>36~          weeks) and breastfeeding can increase and sustain risk reduction behaviors and prevent~          incident STI and HIV infections among HIV-uninfected pregnant women, and~        2. that couple HIV testing and counseling (HTC) can further enhance this effect through~          improved couple communication and emotional and economic support from male partners.~   "
89721|NCT01882933|"~     A prospective, opened, multicentric, randomised, phase III trial with two arms:~        -  Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin~        -  Arm B: curative gastrectomy with D1-D2 lymph node dissection~      Main objective: Compare overall 5-year survival rates in patients surgically treated for~     advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology),~     treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy~     alone.~   "
89722|NCT01882920|"~     The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic~     intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy~     combined with goal directed fluid therapy (GDT) is associated with a significant change in~     morbidity, length of hospital stay and mortality compared to a standard fluid therapy.~     Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT~     group receive fluid intravenous therapy according to a specific treatment protocol guided by~     monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to~     assess stroke volume and cardiac output via an automated pulse contour analysis~     (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and~     colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group.~     In both groups, the investigators evaluate the incidence of major abdominal and systemic~     complications, the total duration of hospital stay, mortality, the total amount of fluids~     administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses~     administered.~   "
89723|NCT01882907|"~     The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin~     to pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes~     inadequately controlled with metformin monotherapy.~   "
89724|NCT01882894|"~     The aim of this randomized control trial is to identify the possible effectiveness of the~     temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).~   "
89725|NCT01882881|"~     The purpose of this study is to investigate the individual and combined effects of dark~     chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid~     peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. It is~     hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids,~     lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared~     to a healthy American control diet; however, the effects will be greater when dark~     chocolate/cocoa and almonds are consumed together versus consumption of each food~     individually.~   "
89726|NCT01882868|"~     Primary Objective:~      To assess efficacy aflibercept + FOLFIRI by objective response rate (ORR)~      Secondary Objective:~      To assess the following:~        -  safety profile~        -  progression free survival (PFS)~        -  overall survival (OS)~        -  pharmacokinetics (PK)~        -  immunogenicity~   "
89727|NCT01882855|"~     Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication~     of acute or chronic liver diseases such as cirrhosis. Due to the diseased liver's inability~     to remove toxins such as ammonia, which is produced in the gastrointestinal tract, the~     ammonia accumulates in the brain and causes forgetfulness, confusion, disorientation,~     concentration and memory problems, changes in mood, decreased alertness and responsiveness,~     changes in sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable~     movements, agitation.~      This study will examine music as a possible external factor that could contribute to~     impairment in attention and progressive memory in cirrhotic patients while driving.~     Sustaining attention is important for learning and remembering new information, for e.g.~     keeping the car within lane and paying attention to cyclists and pedestrians. Prospective~     memory is the ability to remember to perform previously intended tasks at the appropriate~     time or occasion, for instance remembering the correct exit while driving on the highway.~     Impairment in any of these areas may result in serious consequences for patient with~     cirrhosis. There is evidence that some subsets of cirrhotic patients have a diminished~     ability to drive and significantly more motor vehicle crashes and traffic violations. In~     these patients, listening to music while driving may further jeopardize their driving~     ability, which in turn may lead to reduced quality of life and increased medical costs (from~     motor vehicle accidents).~      This is a cross-sectional study designed to determine if there is any effect of listening to~     music on attention and prospective memory in patients with cirrhosis. For these purposes,~     subjects will be asked to come for one study visit, which will last approximately 2 hours.~     During this visit, subjects will undergo a series of screening procedures (consent,~     assignment of subject identification number, demographics, medical history, physical~     examination, vitals, height, weight, and eligibility assessment). If they are found~     eligible, subjects will undergo several neuropsychological assessments to measure any effect~     of music on attention and prospective memory. These assessments include including Number~     Connection Test (NCT), Digit Symbol Test (DST), Cambridge Prospective Memory Test~     (CAMPROMPT) and Inhibitory Control Test (ICT).~   "
89728|NCT01882842|"~     This study aims to see if taking a small sample from the lining of the womb (the 'scratch')~     before starting in vitro fertilization (IVF) treatment can influence the chance of getting~     pregnant and having a healthy, term baby.~      This study also aims to explore why an embryo is not accepted or indeed rejected by the~     lining of the womb. This will be analysed by carefully looking at the sample taken from the~     lining of the womb under the microscope and analysing the levels of natural killer (NK)~     cells. These cells are thought to regulate the implantation process and to be altered in~     some women with infertility and miscarriage.~   "
89729|NCT01882829|"~     There is an urgent need, therefore, to identify well-tolerated, orally available compounds~     that target the NMDA receptor as a novel treatment approach for TRD. The current project~     aims to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA~     antagonist dextromethorphan.~   "
89730|NCT01882816|"~     The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam~     radiation therapy, has on the patient and their thyroid cancer where surgery is not an~     option or where despite surgery, the disease is still present.~   "
89731|NCT01882803|"~     Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in~     subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic~     Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.~   "
89751|NCT01882543|"~     The primary objective of this study is to evaluate the effect of 6 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo on average daily pain in subjects~     with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using~     a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary~   "
89796|NCT01881945|"~     The aim of the study was to validate tools of physiological signal processing and~     interpretation on healthy human volunteers in order to improve the understanding in~     respiratory physiology and its interactions with heart function, and swallowing.~   "
89732|NCT01882790|"~     Autonomic nerve function is involved in both blood pressure (BP) regulation and the~     pathogenesis of coronary artery spasm(CAS), but few studies have been published about the~     relationship between CAS and effect of BP lowering drugs in patients with hypertension. The~     purpose of this study is to investigate the incidence of CAS, atrioventricular (AV) block~     and effect of BP lowering drugs on CAS in hypertensive patients treated with BP lowering~     agents. The investigators will register consecutive patients who underwent coronary~     angiography with an acetylcholine (Ach)-induced provocation test. The investigators will~     include hypertensive patients who were taking antihypertensive drugs, and exclude patients~     who had a documented history of cardiovascular disease or who were not treated with~     antihypertensive agents. CAS is defined as >70% luminal narrowing on Ach provocation and /or~     concurrent chest pain. The study population will be divided into quartiles of rising~     systolic BP and diastolic BP. The incidence of Ach-induced CAS according to each systolic~     BP/diastolic BP quartile will be evaluated.~   "
89733|NCT01882777|"~     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are~     collaborating on a project financed by carbon credits that will distribute household-based~     water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda.~     Prior to the full roll out of the campaign, the implementers are conducting a pilot project~     among 2000 households in western Rwanda. The objectives of this pilot evaluation are to~     document the delivery of the intervention to the intervention population, assess coverage~     and uptake of the intervention target households and conduct a 5-month randomised controlled~     trial among 500 households to assess the impact of the intervention on drinking water~     quality and indoor air quality.~   "
89734|NCT01882764|"~     A study with an 8 week open label phase study followed by a year long placebo controlled~     maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a~     modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent)~     as a concomitant medication. Subjects are required to be in clinical remission or clinical~     response to enter the year long maintenance phase. This study will help evaluate if HMPL-004~     is effective in subjects maintaining clinical remission following successful induction~     therapy achieving clinical remission or clinical response.~   "
89735|NCT01882751|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Previously, most experimental~     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested~     the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers~     that permit error due to undesired motions between markers and the underlying bone. More~     recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.~      ConforMIS has attempted to follow a clearly different path than the major orthopaedic~     companies. They have chosen to offer patients a personalized knee implant based off of each~     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will~     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding~     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze~     the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25~     patients implanted with a traditional TKA design to determine if there are any kinematic~     differences between these TKA designs.~   "
89736|NCT01882738|"~     All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate.~     Cervical length will be assessed in all patients, once abdominally and then vaginally (that~     would serve as golden standard). Correlation would be assessed between accuracy of~     measurement to BMI~   "
89737|NCT01882725|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in increasing local blood circulation in people with chronic heel pain arising from plantar~     fasciitis.~   "
89738|NCT01882712|"~     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel~     0.5% applied topically once daily for 29 days versus vehicle control, in subjects with~     moderate to severe chronic persistent vascular facial erythema~   "
89739|NCT01882699|"~     This study will build upon a previously approved protocol entitled A multi-center~     prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two~     different temperatures in primary insomnia patients (CIP-003; CER1-01-090). In that study,~     150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep~     using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab~     study will be enrolled to complete 2 phases of in home use of the device. In the first~     phase, the durability study, 30 patients are targeted to complete additional in lab~     assessments following 30 days of in home use of the device. In the second phase, the home~     use pattern study, 24 patients are targeted to complete an additional 5 months of in home~     use in which their use patterns will be monitored.~      Hypothesis:~      EEG sleep latency and sleep efficiency following 30 days in home use of the device at~     14-16°C will be similar to those measures after the initial acute, 2-night use in the parent~     study in the 14-16°C condition. The device will demonstrate a benign safety profile over 6~     months in home use.~   "
89740|NCT01882686|"~     A series of case-studies to explore the efficacy of classification based cognitive~     functional physiotherapy according to the classification system proposed by Peter O'Sullivan~     in specific nursing population with non specific chronic low back pain.~      The investigators hypothesis was that treatment targeting the mechanisms behind the problem~     from a multidimensional perspective would be effective to reduce pain, disability and~     sick-leave.~   "
89752|NCT01882530|"~     The combination of different analgesic drugs and/or analgesia techniques is part of the~     standard management of postoperative analgesia. The analysis of the literature reveals a~     lack of comparison of the associations of non-opioid analgesic (NOA) with morphine for~     postoperative analgesia.~      The objectives of this study are :~        -  comparing the morphine sparing effect of different combination of 3 NOA (paracetamol,~          nefopam, ketoprofen) for postoperative analgesia.~        -  determining whether the morphine-sparing effect is associated with or without a~          reduction in the incidence of morphine side effects.~        -  evaluating the effects of NOA on postoperative hyperalgesia.~   "
89753|NCT01882517|"~     To determine the effect of investigational products on serum LDL cholesterol.~   "
89754|NCT01882504|"~     The study will evaluate the safety and biologic activity of gevokizumab in subjects in the~     acute inflammatory phase of pyoderma gangrenosum.~   "
89741|NCT01882673|"~     The long-term goal of this program of research is to disseminate an effective, brief~     computer-based intervention that can be readily integrated into Substance Use Disorders~     (SUD) treatment programs to motivate tobacco quitline use in patients who smoke. The overall~     objective of this application, which is the first step in the attainment of this long-term~     goal, is to fully develop this computer-based intervention, modify it based on initial~     piloting and feedback to insure its feasibility and acceptability, and obtain preliminary~     data supporting the efficacy of the intervention. This will be accomplished by pursuing~     three specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief,~     computer-based intervention intended to motivate tobacco quitline use among cigarette~     smokers in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in~     Tobacco Quitline use) and to develop and pilot test a computer-based, time matched control~     intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60~     smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative~     to CON will result in increased readiness, higher rates of tobacco treatment engagement,~     more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1-~     and 3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up~     period will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during~     the computer session and their associations with tobacco treatment engagement and smoking~     outcomes at 1- and 3-month follow-ups.~   "
89742|NCT01882660|"~     Background of the study: Colon cancer is the second leading cause of cancer-related death~     world wide.~      Although patients presenting with early disease (stage I-III) can be cured, prognosis varies~     from 90% in stage I to 50-80% in stage II and III. Therefore, prevention of metastases after~     early disease is of utmost importance. Derepression of Wnt targets may provide a novel~     target for therapy.~      Objectives: The primary objective of the study is to assess in patients with primary colon~     cancer whether short-course pre-operative treatment with decitabine can increase Wnt target~     gene expression as measured in resected tumors compared to pretreatment biopsies. The~     secondary objective of the study is to assess in patients with primary colon cancer whether~     short-course pre-operative treatment with decitabine can revert CpG methylation and induce~     more favorable tumor characteristics as measured in resected tumors compared to pretreatment~     biopsies. The tertiary objective is to compare changes in Wnt target gene expression, CpG~     methylation and tumor characteristics for Wnt methylated and nonmethylated tumors as~     measured in resected tumors compared to pretreatment biopsies and identify new~     stratification markers.~   "
89743|NCT01882647|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
89744|NCT01882634|"~     To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60~     years through a screening program in Primary Health Care using a hand-held ultrasound and to~     analyze the relationship between cardiovascular risk factors and cardiovascular disease in~     patients with AAA.~   "
89745|NCT01882621|"~     Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity~     induced by cisplatin~   "
89746|NCT01882608|"~     Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur;~     they affect one in four people during their lives. At Sunnybrook, 75% of inpatient~     admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the~     community use cell phones to track the severity of their mood symptoms over time, and~     enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is~     better for detecting exacerbations of illness earlier than standard clinical practice alone.~     In this study, we will assess if MHT can reduce re-hospitalization rates in~     previously-hospitalized patients with mood disorders.~   "
89747|NCT01882595|"~     To compare lung deposition of amikacin in two settings: spontaneously breathing through a~     tracheostomy cannula and through the mouth.~   "
89748|NCT01882582|"~     The purpose of this study is to better understand whether and to what extent the activity of~     immune cells in blood varies over time under normal conditions as assessed in healthy~     subjects. Results of this study will provide the foundation for helping us evaluate changes~     in immune cell activities in response to surgery and drugs used in anesthesia. The overall~     purpose of our research is to understand immune health in the context of anesthesia and~     surgery.~   "
89749|NCT01882569|"~     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and~     adaptive branches of the immune system are affected by surgical trauma. The purpose of this~     study is to use a single cell flow cytometry approach to characterize the cellular and~     molecular mechanisms involved in the inflammatory response to surgical trauma.~   "
89750|NCT01882556|"~     Patients who survive a stroke are often left with an arm that cannot be used. One reason for~     this is that the muscles affected by the stroke become overactive. This is known as~     spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead~     to limb deformities. For example, the wrist and fingers in the arm affected by spasticity~     become stiff and curl into a fist and the hand cannot be used for any functional purpose.~     Palm hygiene can become difficult and patients find this deformity unsightly and painful.~     Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this~     purpose. In current practice this treatment is often used as a last line of defence.~     Although BT can reduce the muscle overactivity, when injected using current protocols, it~     seems to have little impact on the recovery of function and/or treating the limb deformities~     and pain. If BT can be given in the early stages of a stroke, i.e. as soon as the muscle~     overactivity is observed, then we will be able to treat spasticity and may prevent the limb~     deformities and pain from developing. We may also be able to assist the recovery of arm~     movement in some of the patients who would otherwise not have regained this. In addition to~     benefiting the patient, the prevention of secondary complications by early treatment may~     reduce the costs of long term care to the NHS . We hope to discover if our plan of providing~     early treatment with BT is more effective than the current approach. If we demonstrate that~     the treatment is effective we will be able to introduce this new method almost immediately~     within the NHS through our collaboration with doctors and therapists who are actively~     treating patients with this condition.~   "
89755|NCT01882491|"~     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective~     in the treatment of inflammatory erosive osteoarthritis of the hand.~   "
89758|NCT01882452|"~     Depression involves the tendency to recall overgeneral personal memories, a phenomenon which~     has been linked to numerous adverse psychological outcomes. The purpose of this study is to~     investigate whether a group-based Memory Specificity Training (MEST) programme improves~     outcomes in depression, and how this compares to an education and support control group. The~     primary aim is to examine whether MEST, which involves repeated practice retrieving specific~     autobiographical memories reduces depressive symptoms immediately post-treatment, and~     whether this is maintained 3 months after treatment. The secondary objective of this trial~     is to examine the role of hypothesised cognitive processes (ie., rumination, executive~     control, cognitive avoidance) which may underlie improvements in depression and memory.~   "
89759|NCT01882439|"~     To examine the safety and efficacy of tofacitinib in subjects with active psoriatic~     arthritis who have previously had an inadequate response to at least one TNF inhibitor~     either due to lack of efficacy or an adverse event.~   "
89760|NCT01882426|"~     Assess if standardized care-path that features objective evaluations of disease activity and~     time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.~   "
89761|NCT01882413|"~     This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to~     cataract surgery. No treatment is administered in this study.~   "
89762|NCT01882400|"~     By supplying an adequate amount of calcium and vitamin D with the addition of weekly~     bisphosphonate, the investigators will be able to increase bone mass and decrease the~     incidence of fragility fractures in these children with muscular dystrophy.~      The investigators think this treatment will also decrease the intensity of pain frequently~     present in these patients and slow the progression of scoliosis.~   "
89763|NCT01882387|"~     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence~     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing~     allogeneic peripheral blood stem cell transplantation (PBSCT). The study will also evaluate~     the effects of TXA127 on incidence, severity and duration of mucositis; neutrophil~     engraftment and platelet recovery; platelet transfusion requirements; immune reconstitution;~     and duration of corticosteroid use. TXA127 has shown to be well tolerated by patients and~     appears to induce rapid production of neutrophils and platelets in the bloodstream, as well~     as increase the immune system components. TXA127 has also been shown reduce the severity of~     chemotherapy-induced mucositis.~   "
89764|NCT01882374|"~     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence~     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double~     umbilical cord blood transplantation (UCBT). The study will also evaluate the effects of~     TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet~     recovery; platelet transfusion requirements; immune reconstitution; and duration of~     corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce~     rapid production of neutrophils and platelets in the bloodstream, as well as increase the~     immune system components. TXA127 has also been shown reduce the severity of~     chemotherapy-induced mucositis.~   "
89765|NCT01882361|"~     To address the question of the comparison of two courses of Vivitrol with differing lengths~     in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient~     treatment. Participants will be randomized under double blind conditions to a 24 or 48-week~     course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with~     follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections~     in weeks 24 to 48.~   "
89766|NCT01882348|"~     The proposed study is a Randomized Controlled Trial designed to test the sustainability of a~     previously developed, tested, effectively implemented tobacco control strategy—the CEASE~     intervention, employing state of the art tobacco dependence treatment for parents who smoke.~   "
89767|NCT01882335|"~     The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in~     the first 6 months of life on cognition and other determinants of human capital formation~     including behavioral and emotional status; school readiness and attainment; health status;~     fine and gross motor skills; physical growth; and household economic status.~   "
89768|NCT01882322|"~     The objective of this study is to compare the efficacy and safety between a group that has~     been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group~     that maintained Prograf twice daily therapy.~   "
89769|NCT01882296|"~     Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10,~     20, 40mg and Pantoprazole 20, 40mg in healthy male subjects~      Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare~     each dose-response~   "
89770|NCT01882283|"~     A diet-controlled clinical trial which attempts to provide estimates of the effect of black~     tea consumption on serum lipids under tightly controlled conditions, including a controlled~     diet. Mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7~     mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a~     15-week, double blind, randomized crossover trial, during which they consumed a controlled~     low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment~     periods.~   "
89771|NCT01882270|"~     The purpose of this research study is to find out if the infection around 3rd molars and the~     resulting inflammation around the gum also produces a general systemic inflammation.~   "
89797|NCT01881932|"~     In this study the investigators will assess how useful and safe acupuncture is in easing the~     pain, tingling and numbness that is caused by chemotherapy. The researchers hope this will~     prevent the need to reduce the amount of chemotherapy a patient receives.~   "
89798|NCT01881919|"~     The purpose of this study was to test the effect of chronic consumption of Quercetin 500 mg~     tablets on blood uric acid and other biomarkers in adult males.~   "
89799|NCT01881906|"~     The aim of this study is to evaluate the effect of twelve weeks of a physical and~     psycho-social program consisting of: supervised, structured exercise training in a group of~     advanced lung cancer patients (cardio and strength training, relaxation training) twice~     weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this~     intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional~     capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression~     compared to those who do not.~   "
89772|NCT01882257|"~     -  Patients with spinal cord injury (SCI) usually breathe without any mechanical~          assistance, but significant breathing problems occur often during sleep, either because~          the upper airway closes (obstructive sleep apnea; OSA), or because of~          weakness/paralysis of the breathing muscles. These problems often go unrecognized, as~          SCI patients face logistical barriers that cause them to refuse appropriate testing in~          sleep laboratories. We have devised a strategy for diagnosing sleep-disordered~          breathing in the patient's home, using placement of noninvasive devices that monitor~          breathing overnight. This project is designed to test the feasibility and utility of~          this strategy.~        -  After collecting baseline data on symptoms and medical events for four months, the~          home-based studies are performed noninvasively with FDA-approved devices: a type III~          sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor.~          If these studies identify sleep-disordered breathing, noninvasive ventilatory support~          is prescribed according to standard clinical practice. Over the following twelve~          months, the subjects monitor their symptoms daily, and answer quality-of-life~          questionnaires every three months. After 3, 6, and 12 months, blood tests are performed~          to measure blood sugar and cholesterol/lipids. Data is downloaded from the ventilator~          device to monitor compliance and ventilator performance. This study is designed to~          determine the prevalence of sleep-disordered breathing in SCI, the feasibility of~          home-based testing to establish the diagnosis, and the short term effects on symptoms,~          quality-of-life, and associated conditions (glucose intolerance, blood lipid~          disorders).~   "
89773|NCT01882244|"~     Injury to the brain can change the core of a person's being, affecting brain functions~     necessary to accomplish important goals in a complex world. Deficits in attention, working~     memory, and other aspects of goal-directed cognition affect a broad range of pursuits in~     everyday life, and are among the most prevalent and long-lasting consequences of brain~     injuries. The objective of this research is to develop remotely deployed training tools that~     target the most common, persistent and debilitating cognitive functions affected by~     traumatic brain injury (TBI); test the potential effects of the intervention and compare~     these effects to an active comparison intervention; and determine the neurocognitive and~     functional effects of computer-assisted remote training.~   "
89774|NCT01882231|"~     The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor~     protein content, cell density, and microvessel perfusion, obtained before and after a single~     cycle of NAC, to predict eventual tumor response observed at the conclusion of NAC, within~     patients with osteosarcoma or Ewing Sarcoma.~   "
89775|NCT01882218|"~     The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a~     sugar solution into the abdominal cavity) helps blood flow through vital organs in the body~     that may suffer from low blood flow due to surgery. We will also try to find out if the DPR~     will help patients recover faster from liver surgery. Lastly, this study will also try to~     find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood~     called 'cytokines' and a protein called high-mobility group protein 1, which is known to~     cause tissue damage.~   "
89776|NCT01882205|"~     The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the~     rectum is increased and therefore patients should be enrolled in a surveillance program~     eight years after the diagnosis. Until today, official international guidelines for~     endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10~     centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines~     are merely based on consensus during expert opinion meetings rather than evidence based.~     Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the~     number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy~     is therefore considered the gold standard in this study in which we want to compare it to~     the performance and efficiency of new endoscopic imaging techniques.~      Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading~     to a shift in the excitation spectrum towards blue light. The first studies with NBI showed~     that the additional value of NBI in the detection of neoplastic lesions is comparable to~     chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent~     Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is~     achieved via the use of post hoc computer algorithms, applying different filters to the~     stored endoscopic images and enabling a theoretically endless number of combinations of~     filters that can be used. The Pentax I-scan system also allows post hoc modification of the~     images. On the one hand, surface enhancement enables to better highlight mucosal changes.~     Spectral modification allows to apply different modes in analogy with to FICE system.~      These new imaging techniques have a theoretical advantage which is extendedly used for sales~     purposes but has however so far not been proven in ulcerative colitis patients. We want to~     test their clinical use in the screening for neoplastic lesions in patients with long~     standing ulcerative colitis.~   "
89777|NCT01882192|"~     The primary research question is:~      1) Does the planning condition improve adherence to regular physical activity compared to~     the control condition at six months? Hypothesis: Adherence will be higher for the planning~     condition in comparison to the more standard physical activity education condition. The~     effect may wane over time from the initial measurement period but all outcomes will remain~     significantly higher at six months.~      Secondary Research Questions~        1. Does the planning condition improve motivational, health-related quality of life, and~          health-related fitness outcomes compared to the control condition at six months?~           Hypothesis: The planning condition will not affect intentions or underlying motives~          (theory of planned behaviour constructs) for physical activity because its effect on~          behavior is to tie initial intentions better to behavioural action (i.e., behavioural~          regulation) and not to enhance motivation. Health-related fitness and quality of life,~          however, will be higher for the planning condition in comparison to the standard~          physical activity education intervention condition. The effect may wane over time from~          the initial measurement period but all outcomes will remain significantly higher at six~          months in the planning condition compared to the standard physical activity education~          group.~        2. Can group differences among these motivational, behavioural, and health-related fitness~          outcomes be explained through a mediation model? Hypothesis: The covariance of the~          assigned conditions (planning, education) on use/adherence will be explained by~          planning and use of behavioural regulation strategies (i.e., manipulation check). In~          turn, the covariance between planning and behavioural regulation strategies and~          health-related outcomes will be explained by physical activity adherence among~          conditions.~        3. Can motivational variables predict adherence? Do these differ by condition?~           Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the~          concept of active planning. Affective attitude and perceived behavioural control will~          predict intention, intention will predict planning and planning will predict adherence~          across conditions.~        4. Is there an intergenerational, seasonal, or gender difference across primary outcomes~          by assigned condition? Hypothesis: Children will show greater adherence to the planning~          condition than their parents. No differences in gender or season are hypothesized but~          these are exploratory research questions because there is limited research at present~          to make any definitive statement.~   "
89809|NCT01881776|"~     The investigators undertook this prospective, randomized trial to compare the recovery~     profile throughout the first postoperative week in patients receiving continuous (CISB)~     interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for~     arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic~     techniques when used intraoperatively as a sole anesthesia modality were studied on~     postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass~     rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse~     effects. The investigators hypothesized that CISB results in a superior postoperative~     recovery profile as compared to SISB or GA alone.~   "
90162|NCT01877148|"~     The present study aims to investigate the effect of transcranial direct current stimulation~     (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed~     that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this~     way, this study will combine tDCS with physiotherapy in order to enhance the motor~     rehabilitation and the quality of life.~   "
89778|NCT01882179|"~     Heart attacks, or myocardial infarcts, are a major cause of death and disability in the UK.~     Immediate unblocking of the obstructed heart vessel with a balloon catheter and implantation~     of a mesh scaffold (stent) in heart centers is warranted in these patients. Morbidity and~     mortality in this patient group is related to the infarct size. Therefore, there is a need~     to discover novel therapeutic agents which reduce myocardial infarct size and preserve the~     contractile heart function.~      Large trials involving several thousand patients have demonstrated a survival benefit in~     patients with impaired heart function due to a heart attack, who received a~     mineralo-corticoid receptor antagonist (MRA, drug name: spironolactone). In these trials~     patients received the drug late, 3-14 days after the heart attack.~      Our proposal is to investigate whether MRA therapy administered intravenously prior to~     unblocking an occluded heart vessel, can reduce infarct size and as such can prevent long~     term sequelae of heart attacks.~      150 patients admitted to 4 tertiary care hospitals (Heart Hospital London, London Chest,~     Essex Cardiothoracic Center and Leeds General Infirmary) for heart attack will be randomly~     assigned to receive MRA treatment or placebo. The first dose of the MRA will be applied~     intravenously immediately in the catheter suite, even before re-opening of the occluded~     vessel. From the second day on, patients will be prescribed oral MRA treatment, as a pill,~     for a total of three months. Before hospital discharge and after three months, a magnetic~     resonance image (MRI) of the heart will accurately investigate the evolution of infarct~     (scar) size and the contractile heart function and compare the group of patients who~     received the MRA drug versus the placebo control group. Of note, patients with an ejection~     fraction <40% AND signs of heart failure OR diabetes will go on open label eplerenone~     according to current guidelines, instead of the study drug.~      This study will give first evidence, if very early MRA treatment improves heart function and~     should be used as early as possible for treatment of patients after a heart attack.~   "
89779|NCT01882166|"~     The number of children conceived by assisted reproductive technology is increasing in Nordic~     countries as well as worldwide. An important factor of success in treatment of infertility~     is a short time to pregnancy with impact on both economical aspects for the society and~     medical and psychological aspects for the couple. During treatment, success relies on 1)~     optimal stimulation of growth and maturation of multiple follicles by administration of~     exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg /~     embryo with the highest potential of implantation to be transferred to the mother. In the~     present project stimulation of egg production by human urine derived FSH (Fostimon®) and~     recombinant FSH (Puregon®) will be compared. To this end early embryo development and~     kinetics after fertilization will be evaluated. The system to be used is time-lapse~     recording of embryo morphology during the first days of embryo development by means of an~     embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have~     different effect on embryo quality. The hypothesis of the study is that stimulation of egg~     production by these two types of follicle stimulating hormone does not have the same effect~     on early embryo quality.~   "
89780|NCT01882153|"~     The investigators will assess the efficacy of parent delivered interventions in the~     treatment of social and communication deficits in children with autism. By collecting~     information about parent and child functioning before and after intervention, the~     investigators will be able to determine whether the intervention is effective in improving~     child social communication and reducing parent stress.~   "
89781|NCT01882140|"~     The high incidence of burn injuries and mortality and morbidity as well as the high economic~     impact associated with this type of injury justifying the need to develop new technologies~     for the treatment of burn patients. Electrical stimulation for wound healing is a resource~     that has been increasingly used in routine physical therapists, but has the disadvantage of~     needing means of wet contact between the electrode and injury. The other resource used for~     therapeutic healing is conventional electrical stimulation of low intensity for capacitive~     field, a technique of physical therapy intervention not commercially available in Brazil.~     This new technology seems to have significant physiological effects in tissue repair and has~     been used for the treatment of chronic wounds which healed with difficulty. The objective is~     to analyze the effects of electrical stimulation of low intensity for capacitive field in~     healing skin burns. Patients from both genders aged over 18 years who have burns, will be~     evaluated and treated at the Emergency Unit of the Hospital of the Faculty of Medicine of~     Ribeirão Preto, University of São Paulo. The stimulation will be initiated within 24 hours~     after surgery to perform the graft and will be held daily for 60 minutes during the~     patient's stay or until complete healing of the skin. The electromagnetic field will be~     placed on the care of the burned area and / or the donor skin graft, not interfering with~     departmental procedures. Will be performed photographic record standardized wound by a~     digital camera, and then quantified by a computer program. Expected to reduce the period of~     hospitalization and thus lowering the cost of treatment, and the possibility of improving~     the quality of life of patients.~   "
89782|NCT01882127|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose~     Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP),~     compared to conventional high-dose dexamethasone therapy.~   "
89783|NCT01882114|"~     The prevalence of metabolic syndrome in patients suffering from non valvular atrial~     fibrillation is derived from studies regarding recurrences of atrial fibrillation after~     catheter ablation. Prospective studies in european countries are stil lacking. Furthermore~     the impact of metabolic syndrome on cardiovascular events in patients with non valvular~     atrial fibrillation is still unknown.~   "
89784|NCT01882101|"~     Until recently, there is no definite treatment for fecal incontinence that is proven to be~     effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not~     been proven on the randomized controlled trials. Sacral nerve stimulation is too expensive~     although some prospective studies showed the therapeutic potential. Recently, posterior~     tibial nerve stimulation has been reported to be effective with lower cost in comparison~     with sacral nerve stimulation. This study is designed to show the efficacy of posterior~     tibial nerve stimulation compared with biofeedback therapy for fecal incontinence.~   "
89810|NCT01881763|"~     The study aims to compare outcomes of Electroconvulsive Therapy (ECT) using ketamine versus~     methohexital anesthesia in depressed patients. The investigators hypothesize that patients~     who receive ketamine anesthesia during ECT will achieve remission status faster than those~     receiving methohexital anesthesia. Also, at the end of the ECT course subjects will display~     fewer cognitive side effects compared to those treated with methohexital anesthesia.~   "
89904|NCT01880541|"~     The emergence of cognitive disorders after surgery under general anesthesia (GA) is the~     second leading cause of patient complaints (after dental debris caused by intubation~     techniques). These cognitive disorders can range from simple reversible confusion (26%) with~     postoperative cognitive dysfunction without actual recovery (10%).~      The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive~     function remain to this day unknown, but appear promising.~   "
89785|NCT01882088|"~     Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly~     decrease patients' quality of life due to the typical symptoms - heartburn and~     regurgitation. These are caused by increasing number of transient lower esophageal sphincter~     relaxations, regularly recurring reflux of gastric content into oesophagus, acidification of~     the esophagus and consequent esophageal mucosa damage. In addition, an important role is~     played by the increase in production of hydrochloric acid in the stomach, the slowdown in~     the evacuation of the contents from the stomach and increase of gastric and intra-abdominal~     pressure. All of these factors may depend on the patient's diet.~      Theoretical premises of the positive influence of including dietary fiber on the course of~     gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide~     (NO) containing in food, which in turn has relaxing effects on the lower esophageal~     sphincter. In addition, fiber deficiency has been shown to be associated with increased~     chance of developing hiatal hernia, which is associated with greater risk of the disease~     manifestations. There is lack of data about diet modification with its enreaching by dietary~     fibers and their type on the symptoms frequency and objective (i.e. esophageal pH-impedance~     and manometric) parameters.~      Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata~     (isphagula, psyllium). High content of mucuses in the composition of psyllium seed allows it~     to include to group of soft food fibers, which has fundamental value for the appointment of~     a drug at a number of diseases, when, for example, the use of coarse food fibres not~     recommended or contraindicated.~      Mucofalk is the registered medicinal (registration number of the Russian State register of~     medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma GmbH,~     packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally,~     adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1~     packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink~     immediately. Then drink another glass of liquid.~   "
89786|NCT01882075|"~     The investigators want to test during anesthesia the feasibility of a closed-loop automated~     fluid replacement system using cardiac output monitoring as the input value.~   "
89787|NCT01882062|"~     The purpose of this project is to study the efficacy of an anaplerotic treatment on brain~     energy profile evolution at an early stage of the Huntington disease.~   "
89788|NCT01882049|"~     This study is to investigate the use the adjustable gastric band for the treatment of~     obesity in adolescents.~   "
89789|NCT01882036|"~     The focus of this proposal is to define the mechanism by which bariatric surgery acutely~     improves glucose homeostasis. Our central hypothesis is that drastically reduced caloric~     intake early after Roux-en-Y Gastric Bypass (RYGB) improves the pro-inflammatory profile of~     macrophages, which in turn improves insulin sensitivity and glucose homeostasis.~   "
89790|NCT01882023|"~     Currently, there is not a robust, testable neural model available that sufficiently explains~     the development and maintenance of anorexia nervosa (AN) a severe, often fatal,~     adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological~     techniques, our objective is to identify neural mechanisms in the adolescent brain~     underlying AN. This is of high clinical relevance in as much as it will provide a robust~     platform for a diagnostic battery so that physicians can identify those who are prone to~     develop AN at a very early stage of life.~      The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in~     adolescents who have recently been diagnosed with AN, with a battery of cognitive tests~     during a series of clinical visits. 2) To provide a scientific basis for our knowledge about~     how the brain of an adolescent with an eating disorder differs from that of a healthy~     adolescent, by conducting functional and structural magnetic resonance imaging on adolescent~     females with AN.~   "
89791|NCT01882010|"~     The purpose of this study is to determine if Leukine (sargramostim) can be safely~     administered to Parkinson's disease patients for an extended period of time (56 days) and~     restore immune deficits seen in Parkinson's patients compared to controls. The development~     of magnetoencephalography (MEG) as a monitoring tool for PD will also be explored. At~     enrollment and repeating again at two 4-week intervals, whole blood from PD patients and~     controls will be obtained for analyses and the results will be used to calculate immune~     response profiles as a baseline for comparison after drug treatment. Physical examinations~     and motor assessments will also be performed on PD patients. After the 8-week baseline data~     collection, control participation will end and drug treatment of PD patients will begin. PD~     patients will be randomized, and half will receive drug and half will receive placebo.~     Leukine at a dosage of 6 µg/kg or saline as placebo will be administered by subcutaneous~     injection daily for 56 days (8 weeks). During drug treatment, PD patients will be monitored~     every two weeks by physical examinations, motor assessments, and blood analyses. As~     follow-up, four weeks after drug administration has stopped, subjects will again have~     physical examinations, motor assessments, and blood analyses. MEG will be performed on PD~     patients and controls at the start of drug treatment, and on PD patients at the end of the~     drug treatment period and 4 weeks after drug is stopped. In addtion, at the second cohort of~     8 PD subjects, we will evaluate the potential Leukine-induced motor control and mobility~     improvements. Also, levels of the neurotransmitters glutamate, glutamine, serotonin,~     acetylcholine, GABA, norepinephrine and epinephrine in serum/plasma will be analyzed to~     correlate with changes in motor function and drug treatment.~   "
89792|NCT01881997|"~     Patients presenting with painful procedures in the Emergency Department (ED) have been shown~     to frequently have inadequate pain management. The incision and drainage (I&D) of an abscess~     is a common procedure that is viewed by many emergency physicians as only requiring a~     localized anesthetic for pain management. However, it has been documented in previous~     research that there can be disconnect between what emergency medicine physicians interpret~     as painful and what patients experience as pain. A trial will be conducted to focus on use~     of intramuscular (IM) Fentanyl as an intervention to help alleviate pain associated with the~     incision and drainage of an abscess. This is a procedure that rarely receives systemic~     opioids.~      This double blinded protocol will randomize a total of 50 patients patients with abscesses~     to receive either a combination of Fentanyl IM followed by subcutaneous (SC) local~     bupivicaine analgesia or Normal Saline IM followed by SC local bupivicaine analgesia. Only~     opiate naive patients will be enrolled. The primary outcomes studied are patients overall~     satisfaction with procedure, and patients level of pain associated with the procedure.~   "
89793|NCT01881984|"~     This is a medical research study to test a medication in adult patients with a disease~     called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of~     the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is~     currently FDA approved for the treatment of urea cycle disorders. Previous research suggests~     that Ravicti may also be effective in the treatment MCAD deficiency. This study will~     investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD~     deficiency caused by having at least one copy of the 985A>G mutation.~   "
89794|NCT01881971|"~     Hypothesis: Statin therapy will decrease inflammation and slow progression of~     cardiopulmonary abnormalities in HIV.~   "
89800|NCT01881893|"~     The psychosocial development of adults with congenital heart disease (CHD) can be challenged~     by many issues including family overprotection, impaired peer relationships, delayed~     progression into independent adulthood, and difficulties with career and future planning.~     One-third of patients have diagnosable mood or anxiety disorders and the prevalence of~     depression is 3 times that of the general Canadian population. Unfortunately, most adults~     with CHD and significant depression or anxiety do not receive mental health treatment.~     Despite an increasing awareness of the unique psychosocial concerns of this patient~     population by both health care providers and patients, there have been no interventions~     targeting psychosocial outcomes in the adult CHD population. Our quantitative and~     qualitative research suggests that patients themselves are very interested in psychological~     services that target their distinctive life experiences, are provided in a group setting,~     and emphasize coping and resilience. The overarching aim of this proposal is to assess the~     feasibility of a full-scale randomized controlled trial of a group intervention aimed at~     improving the psychosocial functioning, quality of life, and resilience of adults with CHD.~   "
89801|NCT01881880|"~     Study Rationale: an accurate breast cancer staging has a great impact in the management of a~     breast cancer. MRI is considered as the most sensible exam for this staging. However it has~     a low specificity and it may result in extra testing and stress for the patient, add to~     costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time~     than mammography and has a good specificity. Although this modality is very promising, it~     has not been assessed in a population of consecutive patients.~      Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode~     (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of~     additional multifocal, multicentric, and contralateral cancers.~   "
89802|NCT01881867|"~     This randomized phase II trial studies how well glycosylated recombinant human interleukin-7~     (CYT107) after vaccine therapy works in treating patients with hormone-resistant prostate~     cancer that has spread to other areas of the body or has not responded to at least one type~     of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7,~     may stimulate the immune system in different ways and stop tumor cells from growing.~     Vaccines made from white blood cells mixed with tumor proteins may help the body build an~     effective immune response to kill tumor cells. It is not yet known whether glycosylated~     recombinant human interleukin-7 works better with or without vaccine therapy in treating~     prostate cancer.~   "
89803|NCT01881854|"~     The hypothalamus is a part of the brain containing a number of nuclei with a variety of~     functions. It is central in the regulation of hormone secretion, sleep, and circadian~     functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling~     circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and~     cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian~     rhythms and sleep.~      Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus~     indirectly. In general, they are locally aggressive invading crucial structures e.g. the~     hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls,~     craniopharyngioma patients have previously been reported with impaired quality of life,~     increased self-reported general and physical fatigue, increased daytime sleepiness, and~     increased prevalence of severe sleepiness~      Damage to the hypothalamus by local tumour or its treatment might involve the~     suprachiasmatic nucleus and thereby melatonin secretion leading to disturbed circadian~     function causing clinical manifestations in terms of daytime sleepiness and fatigue.~      The investigators aimed to assess the influence of craniopharyngiomas or their treatment on~     melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and~     sleepiness.~      15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were~     included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake~     patterns were characterized by two weeks of actigraphy recordings and sleep diaries.~     Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.~   "
89804|NCT01881841|"~     The goal of this project is to evaluate the feasibility, acceptability, and effect size of a~     new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved~     adolescents in primary care.~   "
89805|NCT01881828|"~     The objective of the proposed research is to evaluate the efficacy and safety of the use of~     metformin in addition to standard insulin therapy in overweight and obese children and~     adolescents, age 12-<20 years, with type 1 diabetes for at least 1 year. Secondary~     objectives are to assess the effect of metformin on C-peptide levels, a measure of how much~     insulin is still being produced by the beta cells of the pancreas, and on vascular~     dysfunction. In addition, an ancillary study is planned to assess if metformin will improve~     tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic~     clamp.~   "
89806|NCT01881815|"~     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects~     who have wounds that show clinical signs of infection, as well as from Subjects who have~     wounds that do not show clinical signs of infection. Swab samples will be collected from~     acute and chronic wounds of different etiologies and these will be analysed for bacteria~     types and markers of infection.~   "
89807|NCT01881802|"~     This trial aims to investigate the effects of opioid-inducing immune suppression on opioid~     drug abused patients. The methods of the investigators research mainly includes the~     expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in~     plasma.~   "
89808|NCT01881789|"~     Phase 1b:~        -  To establish the maximum tolerated dose (MTD) of oprozomib and dexamethasone~          administered in combination with lenalidomide or oral cyclophosphamide~        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in~          combination with lenalidomide or oral cyclophosphamide~      Phase 2:~        -  To estimate the overall response rate (ORR) and complete response rate (CRR)~        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in~          combination with lenalidomide or oral cyclophosphamide~      Secondary Objectives:~        -  To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and~          variability in these estimates when administered in combination with dexamethasone and~          lenalidomide or oral cyclophosphamide~        -  To estimate the duration of response (DOR)~        -  To estimate progression-free survival (PFS)~   "
89811|NCT01881750|"~     This is a research study examining the effectiveness of pivotal response treatment group~     (PRTG) in targeting language skills in young children with autism. Research has demonstrated~     that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements~     in the core symptoms of autism. The purpose of this study is to further examine the~     effectiveness of teaching pivotal response treatment to parents of children with autism in a~     group format. To determine the effectiveness of pivotal response training group (PRTG) it~     will be compared to another parent education group by conducting a randomized controlled~     12-week trial.~   "
89812|NCT01881737|"~     This study will assess the tolerability and effectiveness of pregnenolone in the treatment~     of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone~     found in the body which has been shown to help with the function of nerve cells. It is also~     shown to modulate the activity of certain brain receptors implicated in autism. We hope to~     examine the tolerability of pregnenolone in adults with autism.~   "
89813|NCT01881724|"~     This is a randomized controlled trial with 12 month sleep education as intervention,~     followed by a 12 month observational period, to study whether sleep education would improve~     glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and~     evaluate the neurohormonal changes associated with sleep education.~   "
89814|NCT01881711|"~     Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP)~     testing results can be used in conjunction with imaging to diagnose shunt patency or~     obstruction in pediatric/adolescent subjects presenting to an Emergency Department or~     Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic~     methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will~     be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction~     confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency~     confirmed in surgery.~   "
89815|NCT01881698|"~     Establishment of a range of normal values in pregnancy with the Multiple Electrode~     Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet~     count but platelet function. This has not been studied in ths special patient group. Results~     from this trial will be used as a basis for further investigation of abnormal platelet~     function in pregnancy.~   "
89816|NCT01881685|"~     The objective of the study is to evaluate the association between certain markers in the~     blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the~     device under study.~   "
89817|NCT01881672|"~     Inhalation is a common condition in patients with impaired their awareness requiring~     protection of the upper airway by endotracheal intubation. This inhalation may lead to~     chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration~     of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of~     mechanical ventilation and length of ICU stay increased. However, the proportion of patients~     with such bacterial pneumonia, bacterial ecology and morbidity that are little known.~      The aim of this study is to determine the frequency of bacterial pneumonia in patients~     admitted to the ICU for coma and treated with mechanical ventilation~   "
89818|NCT01881659|"~     HPV testing for primary cervical cancer screening of women over 30 years of age is likely to~     become the standard of care in the near future in many areas of the world. Its high~     sensitivity can significantly improve the effectiveness of screening programs and its~     prolonged negative predictive value can allow extension of screening intervals. However, a~     single HPV test has low positive predictive value and can lead to unnecessary workup and~     over-treatment and generate unnecessary distress. This multi-centric study will screen~     50,000 women with HPV testing and compare several triage approaches that can follow HPV~     testing in order to make an HPV-based screening programme efficient, affordable and~     sustainable.~   "
89819|NCT01881646|"~     The main purpose of this study is to assess the induction of neuroinflammation in brain~     regions of interest for learning and memory in adult patients undergoing urological surgery~     under general anesthesia~   "
89820|NCT01881633|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.~   "
89821|NCT01881620|"~     Hypothesis:~      The investigators would like to demonstrate that diagnosis performance of PET/CT scan~     without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non~     enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a~     pilot study given the few available data concerning this imaging exam reproducibility.~      This study is a prospective single center study.~   "
89822|NCT01881607|"~     This is a community essay to assess the effectiveness of a multi-level (individual, family,~     and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a~     population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools~     were assigned to the intervention or the controlgroup at random. The investigators assessed~     SHS exposure in different settings (at school, at home, on transportation and leisure time)~     and tobacco consumption by means of a questionnaire before and one year after the~     intervention. Based on a previously evaluated intervention to prevent smoking initiation~     (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program)~     including two new activities to prevent passive smoking to be applied at three levels: in~     the classroom (pupils), at the school (pupils, teachers, and parents), and in the family~     (pupils and parents).~   "
89823|NCT01881594|"~     The aim of this study is to compare postoperative ileus between stimulated and unstimulated~     patients prior to ileostomy closure.~   "
89824|NCT01881581|"~     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to~     evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA)~     HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who~     have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.~   "
89825|NCT01881568|"~     The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to~     reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to~     estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through~     serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled,~     randomized, double blind clinical trial that compare efficacy and safety of topical TA~     versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).~   "
89826|NCT01881555|"~     The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2~     therapeutic strategies, one based on coronary angiography guidance and the other based on~     coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery~     disease patients.~      The trial is a prospective, multicenter, French, randomized clinical trial including men and~     women ≥ 18 years presenting with significant multivessel disease defined by coronary~     angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic~     vessels. The patients who give their informed consent will be randomly assigned to a~     therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the~     FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this~     multivessel evaluation (angiography or FFR), the investigator will choose the best~     therapeutic strategy to his discretion (medical optimal treatment, coronary stenting,~     coronary artery bypass graft surgery). The aim of revascularization procedures will be to~     obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be~     treated.~      The primary end point of the trial is a composite of major cardiovascular events including~     death from any cause, myocardial infarction, any hospitalization for coronary~     revascularization performed in addition to initial treatment and stroke at 1 year of~     follow-up.~      Secondary end points will include adverse events, individual major cardiovascular events,~     stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's~     quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.~   "
89827|NCT01881542|"~     Background and project rationale:~      Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and~     constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to~     endanger the lives of both the gravida and the fetus, particularly if treatment is initiated~     inappropriately or in an untimely fashion.~      Diagnosis of preeclampsia is dependent on the finding of proteinuria, determined as being~     over 300mg of protein in a 24 hours urine sample. However, urine collection spanning 24~     hours sometimes constitutes a bottleneck, extending the time to diagnosis of preeclampsia.~     Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring~     that the woman be in proximity to for collection vessel, and increases the length of her~     hospital admission.~      The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion.~     Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital~     stay and consumption of the health system's limited resources. Further, a shorter test may~     reduce the discomfort associated with the 24-hour test and thus increase compliance.~      Previous research has suggested that briefer tests correlate with the traditional 24 hour~     urine collection, however these studies were based on small study populations.~      Research Objective:~      To validate a brief and rapid test for the diagnosis of urinary protein excretion.~      To assess whether, in women with suspected preeclampsia, a difference exists between protein~     excretion during the daytime and at night.~      Methods:~      Urine collection will be performed on pregnant women admitted for investigation of suspected~     preeclampsia, with volumes recorded and samples taken at 6, 12 and 24 hour intervals for~     assessment of urinary protein content. As such, a comparison will be made between the~     protein excretion after 6 and 12 hours with that over a full 24 hour period; in addition,~     comparison will be made between daytime and nighttime urinary protein excretion. The results~     will allow for assessment of whether a shorter test can substitute the full 24 hour~     collection in the diagnosis of preeclampsia; results of women who are shown to not suffer~     from preeclampsia will be used to assess whether a short test can rule out the disease.~     Additionally a urine sample for protein/creatinine ratio will be examined and correlated~     with results of the different collection periods.~   "
89828|NCT01881529|"~     To treat patients with scleroderma by blocking the expression of LOXL2. The investigators~     first need to confirm (through observation) that LOXL2 is overexpressed in disease.~   "
89829|NCT01881516|"~     we plan to conduct this trial to find out：~        -  If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo-~          or radio-therapy？~        -  How about the extent it relieves？the safety and applicability ？~        -  What's the possible influential factor and mechanism ？~   "
89830|NCT01881503|"~     The purpose of this expanded access study is to be able to provide treatment with HBOC-201~     to patients with life-threatening anemia for whom blood is not an option.~      HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen~     carrier in South Africa and Russia.~   "
89831|NCT01881490|"~     The overall objectives of this study are to develop two indices capable of measuring~     intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's~     disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic~     MRI.~   "
89832|NCT01881477|"~     CONTEXT: The physical deconditioning in the critically ill patient is favored by prolonged~     immobilization, which compromises the ability to function. This perpetuates the stays in~     hospital and intensive care units (ICU). To combat this, there physiotherapy intervention~     methods that can reverse or reduce their occurrence.~      OBJECTIVE: The purpose of this research is to determine the effects of passive movements,~     assisted active and resisted, and changes of position on grip strength, joint mobility and~     functional capacity in patients in ICU.~      METHODS: A quasi-experimental intervention, before and after, no control group, in which 40~     patients in an adult ICU in Medellin, receive physiotherapy care. Electrogoniometry,~     dynamometry and functional independence measure, will be made before the intervention and~     serial assessments every four days, until discharge from ICU.~   "
89833|NCT01881464|"~     Study hypothesis - this study will assess the presence of endothelial dysfunction in~     patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.~   "
89834|NCT01881451|"~     The purpose of this study is to use 18F-EF5 PET/CT scans to locate areas with low oxygen~     levels (hypoxia) in patients with recurrent and/or metastatic cancer.~   "
89835|NCT01881438|"~     The purpose of this study is to assess the association of retinal detachment (separation of~     the retina [the innermost layer of the eyeball] from its connection at the back of the eye)~     with exposure to oral ciprofloxacin or oral fluoroquinolones.~   "
89836|NCT01881425|"~     Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower~     intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not~     controlled when using maximum tolerated glaucoma medications.~   "
89862|NCT01881087|"~     The purpose of this study is to evaluate motor block probability throughout time and~     clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by~     a unilateral spinal block technique.~   "
89863|NCT01881074|"~     Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the~     most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite~     conventional medical treatment, some diabetic patients do not seem to be able to reach~     desirable metabolic control. This is a double-blinded, randomized study investigating the~     effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response~     to periodontal treatment in type II diabetic patients with periodontal disease. The~     investigators believe that using triclosan containing toothpaste during periodontal~     treatment will decrease the local inflammatory response and that this reduction will improve~     periodontal status and metabolic control.~   "
89837|NCT01881412|"~     Many children have asthma and this causes problems with their health. A lot of children with~     uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place~     for an intervention for these children. One intervention is prescribing inhaled steroids to~     children with uncontrolled asthma, but currently this is rarely done in the emergency~     department. Inhaled steroids have been shown to be good at making children better long-term~     when they have uncontrolled asthma.~      This study identifies children in the emergency department with uncontrolled asthma using a~     tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children~     meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine~     asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled~     corticosteroid from the emergency department. The investigators hypothesize that children~     who are prescribed inhaled steroids for uncontrolled asthma from the emergency department~     will have better 6 month asthma control than children who receive routine asthma care.~   "
89838|NCT01881399|"~     The burden of iatrogenic bile duct injury (BDI), the most feared complication of~     laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's~     outcomes may be severe ranging from intraoperative repair to liver transplant or patient's~     death. Different techniques have been proposed to prevent BDI.~      Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary~     tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:~        1. ease of use~        2. lack of invasiveness~        3. absence of ionizing radiation to the patient and the operating staff~        4. performed prior to any dissection (prior to critical view of safety)~      Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI~     images) to guide biliary tree anatomy visualization will be also evaluated in this study.~      The study requires a 2-month patient participation.~   "
89839|NCT01881386|"~     This project is designed to investigate whether measurements of lactate in tumours, made~     using a magnetic resonance technique similar to MRI, is an effective non-invasive method to~     detect whether some new targeted drugs are having their desired effect.~      The study hypothesis is that by using magnetic resonance spectroscopy techniques, we will be~     able to observe changes in tumour lactate levels in vivo, in response to treatment.~   "
89840|NCT01881373|"~     The goal is to build social/cultural, political/economic, and physical/built environments~     that will promote active play and intake of healthy food to prevent young child obesity in~     the Pacific Region. Our methods will support local culture in order to achieve this goal in~     these remote, underserved native populations. CHL will engage the community, and focus on~     capacity building and sustainable environmental change.~      The focus of the CHL community-based program is to promote healthy eating and to increase~     physical activity. In order to demonstrate effectiveness, the investigators will recruit and~     measure children in six communities selected in each of our jurisdictions in the Pacific.~     These represent intervention communities, comparison communities, and temporal communities.~   "
89841|NCT01881360|"~     Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac~     disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic~     celiac disease or non-celiac gluten intolerance. The objective of this study is to compare~     the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and~     celiac-type symptoms.~   "
89842|NCT01881347|"~     The present study is designed to test the hypothesis that resveratrol supplementation will~     improve the function of the endothelium in patients with type 2 diabetes mellitus.~      The function of the endothelium will be tested with a non-invasive technique that uses~     ultrasound to measure the amount of dilation that occurs in the brachial artery following~     5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also~     collect blood, urine, and cell samples and test the effects of treatment on protein~     expression, nitric oxide production, and function of mitochondria.~   "
89843|NCT01881334|"~     The objective of this study is to make T-cell depleted stem cells from a family member who~     is a half match (haplo-identical) available on an expanded access basis to patients~     receiving one or two unrelated cord blood transplants who are at a higher risk of not~     engrafting in a safe amount of time. The purpose of the related stem cells is the give the~     bone marrow a jump start towards recovery. Ultimately, the cord blood cells will grow and~     permanently rescue the bone marrow.~   "
89844|NCT01881321|"~     Study design: This is a 2-phase study. During the first phase, the investigators developed a~     contraceptive counseling intervention based on the principles of Motivational Interviewing,~     trained counselors, and conducted a small pilot study to develop skills and refine the~     intervention.~      The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes~     between:~      Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the~     principles of motivational interviewing, vs.~      Group 2 - Women receiving usual clinic care.~      Population: Women, aged 15-29 years, presenting to the University of Chicago family planning~     clinic for termination of an unintended pregnancy.~      Hypothesis: A larger proportion of women who are randomized to receive the MI counseling~     intervention will be using very effective contraception 3 months after the intervention.~   "
89864|NCT01881061|"~     The purpose of this study is to evaluate the role of lung sonography during different PEEP~     settings in ICU patients with ARDS.~   "
89865|NCT01881048|"~     The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil~     capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC).~     Short-term intervention with anti-inflammatory medications will demonstrate a reduction in~     the inflammation and immune suppressive phenotype of PABC, and decreased metastatic~     potential in PABC. This unique window in breast cancer management serves as a valuable~     opportunity to obtain preliminary data on biomarkers and the alterations that occur when the~     system is troubled by a drug or other intervention which will be instrumental in designing~     future therapeutic or preventative strategies for larger clinical study.~   "
89866|NCT01881035|"~     The study is designed to investigate the efficacy of renal nerve denervation in treating~     drug-resistant hypertension in patients with end stage renal disease.~   "
89905|NCT01880528|"~     This pilot clinical trial studies lisinopril in reducing shortness of breath caused by~     radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects~     caused by radiation therapy in patients with lung cancer.~   "
89845|NCT01881308|"~     The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs~     (DMARDs) dose reduction in patients with rheumatoid arthritis (RA).~      Remission is the treatment target in RA, but knowledge about the best way to treat RA~     patients who achieve sustained remission is limited. DMARDs have potential serious adverse~     events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are~     to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients~     in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs~     in this patient group, and to study cost-effectiveness of different treatment options in RA~     remission.~      ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV,~     non-inferiority strategy study. Patients with less than five years of disease duration and~     stable remission for at least 12 months are randomized to either continued stable treatment~     or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and~     synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome~     measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary~     endpoint of the study is the proportion of patients who are non-failures (have not~     experienced a flare) at 12 months. Secondary endpoints include composite disease activity~     scores and remission criteria, joint damage and inflammation assessed by various imaging~     modalities, work participation, health care resource use and health related quality of life.~   "
89846|NCT01881295|"~     This study is designed to compare the effect of sources of potassium on uptake and the~     effect of potassium on blood pressure.~   "
89847|NCT01881282|"~     The purpose of this study is to compare the therapeutic effect and safety of compound~     carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the~     rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of~     pain.~   "
89848|NCT01881269|"~     The purpose of this study is to evaluate the performance of the software that calculates~     respiration rate for the study pulse oximetry monitoring system during transitions of~     ventilation type from spontaneous breathing to controlled ventilation.~   "
89849|NCT01881256|"~     This is a longitudinal, observational study on nutrition, growth and body composition in~     preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm~     period by investigating associations between macronutrient supply, growth, and body~     composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.~   "
89850|NCT01881243|"~     The broad objective of this study is to test the association between hyperoxia exposure~     after resuscitation from cardiac arrest and outcome. Our overarching hypothesis is that~     hyperoxia after ROSC is associated with increased oxidative stress and worsened neurological~     and cognitive outcomes.~   "
89851|NCT01881230|"~     The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in~     combination with either gemcitabine or carboplatin to the combination of gemcitabine and~     carboplatin as first line treatment in female subjects with triple negative metastatic~     breast cancer (TNMBC) or metastatic triple negative breast cancer.~   "
89852|NCT01881217|"~     An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety,~     tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of~     BAY1179470 in subjects with advanced, refractory solid tumors~   "
89853|NCT01881204|"~     The primary objective of this clinical trial is to test hesperidin with and without~     CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary~     objective is the comparison between 41Ca technology and classical biomarker to evaluate bone~     resorption.~   "
89854|NCT01881191|"~     This study will evaluate the effects of Aubagio on changes in the brain using MRI.~   "
89855|NCT01881178|"~     This study has been developed to investigate the anti-inflammatory effects of a commercial~     product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research~     method employs a double blind, placebo controlled, and time-series (repeat measures) design~     with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation -~     testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12~     weeks (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is~     expected that baseline CRP levels in healthy participants will decline.~   "
89856|NCT01881165|"~     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract~     infections (UTIs) in women who consume it. About 150 adult women will participate in this~     study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule~     or a placebo for 12 months. We expect cranberry supplement to have better results than the~     placebo. Subjects will not know which supplement they are taking. The primary outcome is the~     number of UTIs over 12 months.~   "
89857|NCT01881152|"~     The starting hypothesis is that a multilevel educational campaign, specifically developed~     for the local community, can increase public stroke awareness and reduce pre-hospital delay.~      The effectiveness of such intervention will be evaluated according to a cluster randomized,~     stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord,~     AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the~     patients consecutively admitted to the six participating hospitals throughout the study~     period, for suspected stroke or transitory ischemic attack (TIA).~   "
89858|NCT01881139|"~     The purpose of this study is to monitor the impact of exercise training on cardiac functions~     and lipoprotein lipids.~   "
89859|NCT01881126|"~     This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%)~     alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS~     0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering~     therapy.~   "
89860|NCT01881113|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis~     in the conjunctival allergen challenge (CAC) model.~   "
89861|NCT01881100|"~     It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment~     of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of~     treated caries lesions, compared to fluoride varnish therapy only.~   "
89867|NCT01881022|"~     Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire,~     decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus~     adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that~     many couples experience sexual distress following breast cancer, very few interventions have~     been designed exclusively to address these concerns. The purpose of this study is to develop~     and evaluate an online psychosexual program geared to the unique needs of couples~     experiencing sexual distress after breast cancer. This study will utilize a web-based~     approach, allowing couples to participate in the program from the privacy and comfort of~     their homes, and providing a resource to couples who may not otherwise be able to readily~     access support. Accordingly, this project has the potential for widespread positive impact~     for couples affected by breast cancer.~   "
89868|NCT01881009|"~     To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a~     closely monitored 12 hour overnight inpatient study. Once the safety of the device has been~     validated we will move the study to an outpatient diabetes camp setting. The camp setting~     will allow us to obtain pilot efficacy and safety data in a real-life environment.~      We plan to compare the subject control nights to the subject nights on the OCL system to~     assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on~     previous research, we anticipate that the use of the OCL system will contribute to a greater~     percentage of sensor glucose readings in the target range.~   "
89869|NCT01880996|"~     Oncologic patients often report increased fatigue during and after chemotherapy. Evidence~     suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated~     with chemotherapy. Previous studies, mostly performed in a population of breast cancer~     patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of~     life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb)~     (3), and reducing inflammation (4).~      The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and~     fatigue in patients with gynecological malignancies, particularly in patients with ovarian~     cancer.~   "
89870|NCT01880983|"~     The purpose of this study is to identify the biochemical/genetic defects in erythropoietic~     protoporphyria (EPP). People with EPP have skin sensitivity to sunlight and occasionally~     develop liver disease. In this study, the investigators hope to learn the nature of the~     biochemical/genetic defects in EPP because this may help explain the severity of these~     clinical features.~   "
89871|NCT01880970|"~     The aim of this trial is to test the efficacy of an infant formula containing synbiotics on~     the prevention of gastro-intestinal infections.~   "
89872|NCT01880957|"~     The primary aims of this study are to:~        1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar~          disorder patients (BPD) during a major depressive episode (MDE).~        2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT.~        3. Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP.~        4. Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP.~        5. Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.~   "
89873|NCT01880944|"~     Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation~     spinal trauma.~      However, the role of contrast enhancement has not investigated in patients with spinal~     trauma.~      Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI~     for spinal trauma W/U clinically.~      The study hypothesis is that there is no additional gain in addition of contrast enhanced~     study to routine non-contrast MRI.~   "
89874|NCT01880931|"~     To find out the effect site concentration of remifentanil for preventing QTc interval~     prolongation during intubation under propofol-remifentanil anesthesia in normotensive and~     hypertensive patients~   "
89875|NCT01880918|"~     The proposed study is a post marketing, observational, retrospective data collection~     intended to gather and record data on patients treated with the ColonRing device in routine~     clinical practice at 4-6 centers. The data will assist in future evaluating the performance~     of the ColonRing device in regards to the creation of a colorectal anastomosis in Low~     Anterior Resection procedures.~      Hypothesis: The performance of the ColonRing, determined by the rate of complications, will~     be within the acceptable range reported in the literature for alternative treatment~     modalities.~   "
89876|NCT01880905|"~     Ovarian torsion is one of the gynecological emergency. This complication requires high~     clinical suspicion and early detection, to prevent permanent loss of ovarian function. The~     long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure~     the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the~     length between the torsion group and other non torsion patients~   "
89877|NCT01880892|"~     In patients with gastroesophageal reflux and/or laryngopharyngeal reflux with~     cricopharyngeal hypertrophy or Zenker's diverticulum, does cricopharyngeal myotomy increase~     the amount of laryngopharyngeal reflux?~   "
89878|NCT01880879|"~     research topic:helios After registration of clinical research bidders:kinhely bio-tech~     Co.Ltd study design:A prospective single treatment group multicenter clinical study Number~     of patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety~     and effectiveness Mainly studies the finish:1 year target lesion of the failure~      Inclusion criteria :~      one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of~     coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with~     the instructions five:Voluntarily signed the informed consent form exclusion criteria:~     one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies~     four:Participated in other test research in the first 6 months five:Within 6 months after~     PCI plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for~     6 months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6~     months after start of complete into the group~   "
89901|NCT01880580|"~     The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging~     (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary~     data for a future extensive clinical trials.~   "
89902|NCT01880567|"~     The goal of this clinical research study is to learn if a combination of ibrutinib and~     rituximab can help control MCL in patients with relapsed or refractory disease or in~     patients over 65 who have newly diagnosed MCL. The safety of this drug combination will also~     be studied.~   "
89879|NCT01880866|"~     Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe~     activity limitation and death. There are few treatments for PAH and the available~     medications are expensive, difficult to administer and have significant toxicities.~      (-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and~     chocolate. Clinical intervention studies using dark chocolate in normal volunteers and~     subjects at risk for or with established cardiovascular disease have demonstrated~     improvements in peripheral and coronary vascular endothelial function, blood pressure,~     lipids, glucose tolerance and inflammatory markers.~      Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in~     subjects with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will~     reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.~   "
89880|NCT01880853|"~     Early detection of breast cancer through screening has been a common practice in the United~     States and several European countries for decades.It is effective in reducing the mortality~     of breast cancer and improving the postoperative quality of life of patients. Mammography~     has been the standard imaging method for the screening, and in recent years, a supplemental~     ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed~     to define an optimal screening strategy that suits Chinese women and the socioeconomics of~     China.~   "
89881|NCT01880840|"~     The purpose of this study is to compare the safety of 2 different doses of the~     investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of~     allergic rhinitis (AR). This is an open-label study; that is, parent and child will know~     which group each is in.~   "
89882|NCT01880827|"~     Obesity is a worldwide problem and leads to multiple metabolic and endocrinological~     problems.~      Bariatric surgeries are a growing field as a treatment choice for morbid obesity (BMI > 35~     kg/m2). Clinical and research evidence shows that shortly after RYGB, T2DM resolves with~     improving glucose tolerance. Foregut hypothesis behind bariatric surgeries postulate, that~     bypassed portions of intestine contain a substance, that acts as an anti-incretin, ie. to~     counteract metabolically favourable incretins. In view of the recent studies, it may be that~     GIP is really the anti-incretin behind this hypothesis.~      The current study is conducted to investigate the vasoactive roles of the GIP. The~     investigators aim to show that GIP is the major contributor to the blood flow and tissue~     blood volume observed in postprandial state.~   "
89883|NCT01880814|"~     The purpose of the study is:~        1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the~          long-term goal of developing a personalized treatment for child depression.~        2. To collect pilot data on ways to personalize treatment for child depression using~          cognitive behavioral therapy (CBT), caregiver-child treatment, or both.~   "
89884|NCT01880801|"~     The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic~     purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of~     healthy mothers.~      In order to prevent severe thrombocytopenia in infants born to mothers with ITP.~   "
89885|NCT01880788|"~     The study will be designed as a case control evaluation to compare the genetic profiles of~     three groups of patients categorized according to diagnosis.~      Group 1 - CNV secondary to CSC Group 2 - CSC without CNV Group 3 - CNV secondary to advanced~     AMD.~   "
89886|NCT01880775|"~     In this prospective randomized study the investigators aimed to investigate difference of~     the duration of spinal anesthesia, discharge times and efficacy between low dose heavy~     Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.~   "
89887|NCT01880762|"~     Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and~     trabecular moieties of marrow. An ideal protocol would differentiate red marrow from~     neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses~     the feasibility of a multiple gradient echo sequence for differentiation of water and fat~     constituents of marrow, combined with T2* mapping to interrogate the trabecular component~     The investigators hypothesize that these techniques will allow better identification of~     lesion type than routine MR sequences, and can be used to quantitatively characterize~     myelomatous marrow replacement, with iliac crest biopsy (which is routinely performed in the~     diagnosis of myeloma) as gold standard.~      Fluoro-deoxyglucose (FDG)/PET CT imaging can detect FDG uptake in active myeloma and is~     obtained routinely for certain cohorts of patients with myeloma. PET/CT is commonly used in~     both initial whole body assessment and in monitoring remission. PET has been found to be~     about 59% sensitive and 75% specific for detection of myeloma .~      Myelomatous lesions are detected on MRI by the replacement of marrow fat. Routine MRI~     however is limited by scope/field of view, usually evaluating marrow in a single anatomic~     region (such as an extremity, the pelvis or spine). To assess the diffuse marrow involvement~     in MM, whole body MRI imaging potentiates near global assessment of the marrow, which aids~     in evaluating tumor burden, and may be useful in staging.~   "
89888|NCT01880749|"~     The primary objective is to estimate the proportions of vestibular schwannomas (VS) and~     meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as~     determined by immunohistochemistry. This is a phase 0 PK (pharmacokinetic) and PD~     (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and~     sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or~     meningioma surgery, and blood and tissue samples will be obtained for further analysis.~   "
89889|NCT01880736|"~     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and~     safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin~     degludec in inadequately treated subjects with type 2 diabetes.~   "
89890|NCT01880723|"~     Our aims were to determine if exhaled breath condensate (EBC) could detect differences in~     ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the~     albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be~     lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase~     EBC chloride.~   "
89903|NCT01880554|"~     Hypothesis: Use of contrast ultrasound showed interesting results, which can increase~     ultrasonography sensitivity performed during surgery in the evaluation of operable liver~     metastases.~      This study is a two-stage phase II multicenter study (Simon's two-stage).~   "
89891|NCT01880710|"~     319 Women undergoing hysterectomy for benign (not cancer) indications were randomly~     allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15~     years ago. They were followed by questionnaire at time of surgery and up to 5 years (not yet~     published) after the surgery and evaluated regarding following outcomes: Urinary~     incontinence, pain, bowel problems, per and postoperative complications, sexuality, quality~     of life, pelvic organ prolapse and vaginal bleeding. Now the investigators are conducting a~     15 year follow up with the same out-come measures but also including physical examinations~     regarding Urinary incontinence, voiding difficulties, pelvic organ prolapse and problems~     with the cervix. The investigators' hypothesis is that several of the out-come measures will~     be present in more cases than earlier due to age and menopausal changes. The investigators~     expect more urinary incontinence in the subtotal group as this was seen at earlier follow~     ups. The investigators expect to find more women with pelvic organ prolapse with the~     physical examination than by questionnaire alone, possibly with a higher incidence in the~     subtotal group.~   "
89892|NCT01880697|"~     The present study is designed to confirm the safety and immunogenicity of cell-derived,~     trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years~     and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by~     Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days~     post immunization. The vaccine composition will be based on the WHO-recommended influenza~     strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are~     intended to support the use of this vaccine in future influenza seasons if the recommended~     vaccine composition remains the same, in compliance with the requirements of the current EU~     recommendations for clinical trials related to yearly licensing of influenza vaccines.~   "
89893|NCT01880684|"~     The aim of this study is to evaluate the correlation of capnography with non-invasive~     measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid~     challenge, a passive leg raising maneuver, using thermodilution as the gold standard.~      The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the~     increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising~     maneuver.~   "
89894|NCT01880671|"~     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of~     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,~     and presence of a preventive effect post treatment.~   "
89895|NCT01880658|"~     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for~     resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is~     high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy~     with capecitabine is still unknown.~      PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy~     followed by maintenance therapy with capecitabine to see the efficacy and safety, then to~     investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV~     colorectal cancer.~   "
89896|NCT01880645|"~     The goal of this clinical research study is to learn if it is feasible to use find (using~     ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine~     lymph node surgery.~      In standard care, all affected lymph nodes are removed. In this study, however, the~     cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under~     the arm will be removed after that.~   "
89897|NCT01880632|"~     1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or~          cT4aN+M0);no previous chemo or radio therapy.~        2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.~           Secondary objectives:~             -  The progression free survival (PFS) in the perioperative treatment of locally~               advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);~             -  percentage of pathological response ; percentage of grade 3 or 4 adverse events as~               safety profile of perioperative treatments;~             -  D2 resection -rate after neoadjuvant chemotherapy of XELOX;~             -  Overall survival;~             -  QOL during the whole period of treatment.~        3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate~          the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative~          treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.~        4. Treatment plan:Patients will be given the perioperative chemotherapy as below once~          recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:~          Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1~          week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.~        5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of~          gastric operations in China, more than 500 per year.~   "
89898|NCT01880619|"~     This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and~     Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral~     stents.~   "
89899|NCT01880606|"~     Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light~     colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with~     PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer~     surveillance programs. However, it does not permit detection of early dysplastic lesions.~     Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify~     flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and~     intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly~     developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa~     using laser-based endomicroscopy together with intravenous administration of fluorescein~     (FITC).~   "
89900|NCT01880593|"~     The purpose of this study is to test the antidepressant effect of ketamine when given~     repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention~     strategy for patients with treatment-resistant depression (TRD) who respond to an initial~     series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic~     (a drug used to produce loss of consciousness before and during surgery). Ketamine is not~     approved for the treatment of major depressive disorder and is considered experimental in~     this study. An additional purpose of this study is to research the effects of ketamine on~     brain function.~      You may qualify to take part in this research study because you have been diagnosed with~     major depressive disorder (MDD) and have not responded to past treatments.~   "
89906|NCT01880515|"~     1. Advanced NSCLC have a poor prognosis and the positive impact of chemotherapy is limited~          by the development of intrinsic and acquired resistance.~        2. Over the past decade, less toxic agents such as the innovative targeted therapies, i.e.~          erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good~          quality of life with a low toxicity~        3. BIBW 2992, an aniline-quinazoline, is an EGFR and HER-2 irreversible inhibitor, and it~          has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2~        4. This molecule have shown benefits as a single agent in pre-treated patients who have~          progressed despite platinum-based chemotherapy, with a minimal toxicity compared to~          chemotherapy~        5. BIBW 2992 is associated with adverse effects similar to those for erlotinib and~          gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life in~          patients and lead to inconsistent EGFR inhibitor dose administration~        6. There is no a standard treatment for rash, but case reports have tried to demonstrate~          the benefit obtained with alcohol-free emollients, sunscreen with titanium dioxide or~          antibiotic (topic or oral) treatment such as clindamycin or doxycycline,~          anti-inflammatory drugs such as steroids and isotretinoin in the treatment of these~          cutaneous injuries.~        7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare~          the prophylactic antibiotic treatment using tetracycline and general dermatological~          recommendations versus using only dermatological recommendations, in patients~          initiating the treatment with BIBW 2992~   "
89907|NCT01880502|"~     A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I)~     to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.~   "
89908|NCT01880489|"~     The objective is to expand and refine an intervention for transgender women (TW) into a~     7-session individual- and group-based intervention that is scalable for community settings~     to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering~     behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and~     subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention~     to a wait list control condition.~   "
89909|NCT01880476|"~     This study will examine the feasibility and acceptability of a 6-month interprofessional~     community-based health promotion program, and explore its effects on older adults'~     self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph~     (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to~     participate. Participants must be English speaking, community-dwelling, independent in~     activities of daily living, and mentally competent to give informed consent. The 6-month~     intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian~     from DCG; participation in a monthly Diabetes Wellness Day group program offered through the~     Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained~     volunteers at the Diabetes Wellness Day group program; care coordination by the DCG~     Registered Nurse to help participants access necessary supports and services; and monthly~     team conferences between care providers at DCG and the GWSA to develop a client-centred plan~     of care. To evaluate the program, participants will complete interviewer-administered~     questionnaires before and after the intervention, and care providers and peer volunteers~     will take part in group interviews.~   "
89910|NCT01880463|"~     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in~     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence~     and/or progression of dry eye disease.~   "
89911|NCT01880450|"~     Project Prepared is a theoretically based, comprehensive, intensive group intervention that~     is designed to prepare early adolescents for middle adolescence and its challenges. It~     emphasizes skills in avoiding risky sexual situations, and provides medically accurate~     information about sexual development, sexually transmitted infections and pregnancy.~     Effectiveness is measured by using a randomized control trial design and tracking~     differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge,~     sexual self-efficacy; intention to use a condom); relationship factors (immature romantic~     beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and~     resilience.~   "
89912|NCT01880437|"~     This study will assess the safety and efficacy of vismodegib in patients with~     relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk~     myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib~     150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in~     combination with cytarabine 20 mg subcutaneously for 10 days.~      Anticipated time on study treatment is until disease progression, intolerable toxicity, or~     patient withdrawal of consent.~   "
89913|NCT01880424|"~     This clinical trial is an international, multicenter, randomized, double-blind,~     placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.~     Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be~     randomized at up to 60 trial centers in China, Australia, and New Zealand.~      The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12~     weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment~     Period, patients meeting the entry criteria for this trial will be randomized to one of two~     double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).~   "
89914|NCT01880411|"~     Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose~     Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.~      PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with~     low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial~     lesions (HSIL) of the cervix and induces a measurable immune response.~   "
90074|NCT01878318|"~     This open-label, single arm study will evaluate the effect of RoActemra/Actemra in~     combination with methotrexate on articular damage in the hand (synovitis/osteitis and~     erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate~     response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will~     receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.~   "
89915|NCT01880398|"~     Background: Fistula in ano is one of the most common diseases of the ano rectal region.~     Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature.~     Commonly prevalent surgical treatment for anal Fistula, that is Fistulectomy does not~     provide successful cure for the disease, post operative complications and recurrences being~     common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta~     Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra~     treatment for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and~     Nadi-Vrana(Sinus) with Ksharsutra was practiced by Sushruta (1000-600B.C.) .~      Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various~     types of Fistula.~   "
89916|NCT01880385|"~     Multi-center, non randomised, open label, non controlled pilot study. Evaluating the~     treatment of bevacizumab in association with pre-operative chemotherapy, followed by~     surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.~   "
89917|NCT01880372|"~     The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have~     moderate non-proliferative diabetic retinopathy.~      The primary aim of this study is to test the hypothesis that the addition of alpha lipoic~     acid in a diabetic patient's therapeutic regimen can decrease the progression of diabetic~     retinopathy and preserve visual acuity.~   "
89918|NCT01880359|"~     The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from~     this class are used against infection. In addition, nimorazole makes tumor cells more~     sensitive to radiotherapy.~      Therefore, the investigators want to find out whether the addition of nimorazole to the~     standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows~     activity against your type of head and neck cancer and is safe.~      Furthermore the investigators will investigate if a specific examination done with your~     tumor tissue will help to predict whether the treatment will work or not.~      To find out if the activity observed with this treatment is not caused by chance alone, the~     investigators need to obtain data from patients who receive this treatment and from patients~     who receive other treatments.~      The data from these two groups of patients will be compared to see which treatment is~     better.~      Participants will be split into 2 groups. Each group will receive different treatments. The~     treatment each group receives is determined by chance using a computer program. This works~     like flipping a coin and is called randomization. This helps to make sure that groups of~     patients are similar when the study starts. Neither you, your study doctor, nor the study~     staff can influence in which group you will be placed or which treatment you will receive.~      If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy~     with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment.~      If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy~     with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It~     looks like the real one, but it is not. It contains no active ingredient/medicine.~   "
89919|NCT01880346|"~     The investigators predict that a powder pill form of vitamin D will be more effectively~     absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.~   "
89920|NCT01880333|"~     The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy~     that was designed to be a less restrictive alternative to the traditional ketogenic diet.~     This diet is started on an outpatient basis without a fast, allows unlimited protein and~     fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance~     in resource constraint settings with paucity of trained dieticians. However, there is~     paucity published data on the use of the modified Atkins diet in refractory epilepsy in~     young children. This study aims to evaluate the efficacy and tolerability of the modified~     Atkins diet in refractory epilepsy in young children.~   "
89921|NCT01880320|"~     The study hypothesis are based on the assumption that :~        -  CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical~          Gel Vehicle in the overall population and in the subgroup of severe Subjects~        -  CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable~          safety and tolerability profile~   "
89922|NCT01880307|"~     The purpose of this study is to determine whether a top-down treatment approach, prescribing~     infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual~     step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe~     pediatric Crohn's disease (CD) patients.~   "
89923|NCT01880294|"~     The purpose of the study is to evaluate the differences or similarities in the results~     obtained with two different scoring systems for chronic constipation in Asian participants~     consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility~     Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and~     the ROME III diagnosis criteria (western gold standard).~   "
89924|NCT01880281|"~     -  The G coupled-protein receptors 99 (GPR99) was discovered in 2002 by Wittenberg et al.~          and is involved as a metabolic receptor. It has been shown that the natural ligand of~          GPR99 is an intermediate in the Krebs cycle, alpha-ketoglutarate (aKG). Studies done on~          rats have shown that aKG is measurable in the blood, freely filtered by the glomerulus~          and highly reabsorbed in the proximal tubule in metabolic acidosis, while it is not~          reabsorbed in metabolic alkalosis. No absorption or secretion of aKG intervene between~          the end of the proximal tubule and the final urine. Thus, having a receptor aKG in the~          distal tubule creates a paracrine communication with the proximal tubule, informing~          about the acid-base status of the body and allows adjustment of the urinary excretion~          of acid or base.~        -  The hypothesis is that GPR99 is aKG sensor in the distal tubules and allow to report~          the acid-base status (determined by the metabolic activity of the proximal tubule) of~          the body to the distal tubule. This can then adapt the urinary excretion of acid or~          base in the final urine. Acidifying the body by a high meat consumption associated with~          a test of acidification, the kidney should reduce its aKG excretion and the~          concentration of this metabolite should be even lower in the urine. And vice versa in~          the case of alkalizing the body through a vegetarian diet associated with an alkalizing~          test.~        -  Twelve healthy omnivorous volunteers will be selected. First inclusion visit includes~          verification of inclusion/exclusion criteria and signed informed consent. Urine and~          plasma baseline measurements will be performed and volunteers will meet a dietician.~          This person will tell them concerning meat and vegetarian diet as well as how to have a~          diet with 6g of salt per day.Volunteers are then randomized in order to determine which~          diet they will start first.The first phase will last during 4 days. The diet is~          followed during 3 days, and a 24-hour urine collection will begin on the third day at~          7: 00 am. The fourth day, volunteers will have an investigational's day at the~          investigation's center after completing their urine collection at home (7:00 am).~          During the day of investigation, volunteers will give their urine (8: 00 am,~          corresponding to the baseline urine), and then the meat arm will receive a tablet of~          50meq of NH4Cl and the vegetarian arm will receive a tablet of 1g of NaHC03.~          Volunteers will stay in the investigation center for 6h. Each hour since 8:00am, a~          urine sample will be taken, and at 3 hours and 6 hours post-tablet, a blood sample will~          also be made.This investigational's day will be followed by one to two weeks of~          treatment washing out. After that, the second phase will begin and will as the first~          phase excepted that the diet will be inversed.~           5 other healthy vegetarian or vegan volunteers are recruited. Inclusion visit is the~          same as omnivorous volunteers. Only investigational's day at the investigation's center~          will be performed (no diet, no urine collection).~   "
89925|NCT01880268|"~     This study integrates the wireless EEG system with an ordinary rehabilitation device (an~     upper limb ergometer, arm bike) used in the Department of Physical Medicine and~     Rehabilitation at our hospital for a brain-computer-interface (BCI)-controlled~     neurorehabilitation device, and aims to test the effectiveness of this device. We~     hypothesize that, the coupling of electroencephalographic signals related with initiation of~     limb movements with a mechanical device which assists the intended movement is effective to~     facilitate motor recovery in patients with brain lesion. We propose to enroll 20 patients~     with cerebrovascular accident (CVA) (4-24 months after the onset of CVA) and the patients~     will be randomly assigned to experimental (using BCI controlled device and undergoing~     standard rehabilitation) and control groups (undergoing standard rehabilitation alone). To~     compare the rehabilitation results among these groups, we propose to use various assessment~     tools including clinical evaluation (Fugl-Meyer assessment, Modified Ashworth scale, Motor~     Activity Log, Functional Independence Measure) as well as functional Magnetic Resonance~     Imaging (fMRI) and Diffusion Tensor Imaging (DTI) before, immediate and 2 months after~     completion of the training protocol.~   "
89926|NCT01880255|"~     In this study, the investigators will be examining the effects of repetitive transcranial~     magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and~     schizoaffective disorder. Half of the study participants will be chosen by chance to receive~     active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS~     will feel the same as active rTMS only there will be no direct brain stimulation. This is~     necessary to ensure that active rTMS is efficacious in the enhancement of memory in~     individuals with schizophrenia. Based on results from a recently published pilot study, the~     investigators propose that active rTMS treatment will result in a significant improvement in~     working memory performance compared to sham rTMS treatment.~   "
89927|NCT01880242|"~     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to~     long-term complications range from rather immediate elastic recoil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from~     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents~     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug~     Eluting Stents (DES) significantly improved on the principle of BMS by adding an~     antiproliferative drug (directly immobilized on the stent surface or released from a polymer~     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the~     incidence of restenosis and resulted in a better safety profile as compared to BMS with~     systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease. This~     observational registry is designed to investigate and collect clinical evidence for the~     clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers~     patient population in daily clinical practice.~   "
89928|NCT01880229|"~     BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a~     single wearable motion sensor that is worn on the torso. The objectives of this~     observational study are the following: 1) to test the efficacy of PAMSys for objectively~     assessing a persons risk of falling based on activity data measured during activities of~     daily living and 2) to test the efficacy of PAMSys for identifying precise early physical~     activity or functioning indicators of frailty in those who are pre-frail or frail as~     compared to non-frail controls.~   "
89929|NCT01880216|"~     Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs~     when a thrombus forms in one of the large veins, usually in the lower limbs, leading to~     either partial or complete blocked circulation. The condition may progress to severe health~     complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and~     effective manner.~      The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and~     pulmonary embolism in the short term and to prevent recurrent events in the long-term.~     Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment~     also increases the risk for major hemorrhage.~      This trial aims to optimize the current medical knowledge on the effectiveness and safety of~     two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein~     thrombosis.~   "
89930|NCT01880203|"~     The purpose of the study is to investigate the contribution of molecular cytological~     analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with~     indeterminate cytology (IC)~   "
89931|NCT01880190|"~     Various stimuli such as trauma, infection and major surgery may alter the physiologic immune~     balance and initiate systemic inflammatory processes. This pathophysiological event is~     characterized by the release of potent inflammatory mediators into the circulation.~      Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or~     IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory~     response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs)~     in the inflammatory response. The MMPs constitute a family of enzymes that are structurally~     related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM)~     components and play an important role in wound healing and remodeling of the ECM. The~     Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.~      The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many~     factors may attributed to this response, such as the kind of operation, the extent of~     surgical trauma, the patient's medical history and therapy, as well as the type of~     anesthesia used. Apart from that, the kind of fluids administered for volume replacement was~     revealed to alter the inflammatory processes. Several studies have addressed on this issue~     mainly involved abdominal surgery and provided compelling evidence that perioperative fluid~     optimization produces benefits for the patient, with regard to inflammatory biomarkers such~     as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They~     support that the different volume replacement strategies, using only crystalloids or~     combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune~     response. However, the relevant studies investigated different inflammatory biomarkers, and~     usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.~      In our study we investigated the hypothesis that intra- and postoperative volume replacement~     with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid~     therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1,~     cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated~     postoperatively. Their changes during the first 24 postoperative hours consisted our primary~     outcomes.~   "
92183|NCT01849614|"~     The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold~     (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast~     cancer radiation therapy, can reduce side effects to the heart.~   "
89932|NCT01880177|"~     The purpose of this qualitative work is to inform the content and structure of a new~     screening measure for identifying undiagnosed at-risk COPD cases in primary care and support~     content validity of the measure. This work will build on the results of a comprehensive~     literature review and data mining analyses by identifying the symptomatic and health event~     experiences of at-risk and newly diagnosed patients, as described by the patients~     themselves. Specific objectives are as follows:~      Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent~     diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The~     qualitative information obtained in these focus groups will be used to develop a new~     questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.~      Objective 2: To review the new questionnaire with a new set of participants with a recent~     COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b)~     the content of each question is appropriate and understandable to participants, (c) the~     intended connotation of each questions is consistent with participants' interpretation or~     assigned meaning, and (d) to assure that content is not seen as redundant across items. This~     will be done through one-on-one cognitive interviews.~      Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without~     or with a new diagnosis of COPD and the consistency of readings between electronic and~     mechanical readings in these patients. This information will be used to inform the~     development of peak-flow meter instructions for use as part of the screening methodology.~   "
89933|NCT01880164|"~     Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal~     deformity.~   "
89934|NCT01880151|"~     Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD~     stages as part of the disease, including a preclinical stage. This underscores the~     importance of early prognosis of AD when it is still possible to influence the course of the~     disorder. The investigators propose a comprehensive project which will target the~     data-driven modeling of the disease development. This goal will be achieved by creating and~     validating a battery of new sensitive biomarkers for clinical evaluation and prediction of~     AD in individuals. The AD-related brain changes will be assessed by noninvasive functional~     EEG measured during an episodic memory task in subjects at different stages of AD, as well~     as in healthy controls. The novel functional biomarkers will be extracted using a rigorous~     multistage selection procedure involving advanced methods for feature extraction, as well as~     statistics and classification for optimal selection. The ESTIMATE project will serve as a~     first step in an extensive array of research procedures which will enable the early clinical~     identification of Alzheimer's disease in elderly individuals who could then take advantage~     of preventive pharmaceutical therapies.~   "
89935|NCT01880138|"~     Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common~     postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in~     the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as~     measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the~     risk of EA for each increment of 10 points in the child's state anxiety score. So,~     Alleviates preoperative anxiety in Children maybe decrease the incidence and severity of EA.~     Preschool children enjoy watching animated cartoons, and they can be immersed to animated~     cartoon so they become oblivious of their surroundings. Therefore, viewing an animated~     cartoon maybe reduce preoperative anxiety in children. This study was performed to determine~     effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr~     after general anesthesia~   "
89936|NCT01880125|"~     1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg~          acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325~          mg acetaminophen formulation after a single dose and at steady state~        2. Subjects: Healthy subject~        3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and~          immediate release treatment profiles at steady state.~   "
89937|NCT01880112|"~     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will~     be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is~     intended to prevent infection from the surgery. It is unknown what the best dose for the~     usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of~     the tissue just under the skin will be biopsied at the time the incision is made and at the~     time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken~     as the womb is stitched closed after the delivery. Blood tests will be done at the start and~     end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical~     cord after the baby has been delivered and the umbilical cord has been cut. The umbilical~     cord blood sample will be tested for the antibiotic level. These tests will be used to find~     out if the usual dose of medicine is enough or if more medicine is needed to prevent~     infection in normal weight women undergoing c-sections.~   "
89938|NCT01880099|"~     You are invited to participate in a research study at the VA Connecticut Healthcare System~     (West Haven campus) that examines whether a medication called galantamine can improve your~     learning and memory, and also help you to quit smoking. You have been invited to participate~     because you currently smoke cigarettes, and want to quit smoking. If you are eligible and~     agree to be in the study, your participation will last for approximately 8 weeks. To~     determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking~     self-administration in a human laboratory model and b) improving abstinence rates at the end~     of 4 weeks of treatment.~   "
89945|NCT01880008|"~     Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after~     multimodal therapy, outcomes remain poor, with a median survival of one year. Although~     advanced imaging methods have been suggested as molecular markers of prognosis and~     therapeutic response, these methods have not been validated for clinical use. In this~     exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of~     glioblastoma will be followed prospectively for two years. The study examines how PET and MR~     imaging signals change following administration of a standard radio-chemotherapy treatment~     regimen to determine whether these imaging modalities can provide early indicators of~     response to therapeutic intervention. The investigators hypothesize that decreases in uptake~     of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy~     will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the~     investigators also will identify changes in diffusion and hypoxia MR imaging that may also~     correlate well with treatment response.~   "
89939|NCT01880086|"~     The purpose of this randomized controlled clinical trial is to evaluate the effects of~     clomiphene citrate compared to placebo (substance without active medication) in men who are~     taking pain medication (opioids) for chronic pain conditions and who have low blood~     testosterone levels.~      The condition of men having low testosterone with long-term pain medication (opioid) usage~     is called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain~     medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately~     result in decreased testosterone production by the testes. Typical symptoms of low~     testosterone (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis,~     anemia, erectile dysfunction, delayed ejaculation. In addition, men with low testosterone~     may experience decreased attention, and decreased libido, fatigue, and depressed mood. Few~     studies have looked at hormonal changes caused by long-term opioid usage in men.~      Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which~     inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to~     raise testosterone in men with low testosterone (due to reasons other than chronic pain~     medication). Clomiphene citrate is also known to lead to increased sperm production in men~     with low testosterone unlike testosterone topical or injection medications. Although~     clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal~     side effects, no group has previously studied clomiphene citrate as treatment in patients~     with OPIAD.~   "
89940|NCT01880073|"~     A thorough infertility evaluation commonly involves determining whether a woman's fallopian~     tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are~     hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus~     and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye~     is visualized passing through the fallopian tubes).~      The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes~     a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by~     ultrasound. FemVue can be efficiently performed in a physician's office and is minimally~     invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry~     the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast.~     It does, like the other two methods, carry a small risk of infection.~      This study will involve using the FemVue device on patients under anesthesia in the~     operating room before they undergo scheduled laparoscopic chromopertubation, the gold~     standard for evaluating tubal patency. The two methods will be compared to determine the~     accuracy of the FemVue device.~   "
89941|NCT01880060|"~     Given the prevalence of overweight and obesity, worksite-based health promotion programs~     have been recommended due to their potential reach and social support impact. Within~     worksite contexts, many strategies to prevent and treat obesity have focused on educational~     programs delivered in person or to small groups that target knowledge acquisition and~     strategies targeted at individuals to improve their dietary and activity practices. These~     programs have been criticized because they typically reach a small percentage of workers—and~     seldom those that could benefit most, are of short duration, and have typically small~     effects that are not sustained. They have also typically been conducted in large worksites~     that have the greatest resources. The lack of success of these programs may be due to: 1)~     inadequate intervention intensity, 2) implementation challenges, and 3) a lack of~     theoretical models as the bases for intervention development. To overcome the limitations of~     previous research we will conduct a 2 group randomized controlled trial to determine the~     reach and effectiveness of an extensive intervention that: (a) is based upon sound theory,~     (b) is delivered primarily through scalable interactive technologies, and (c) leverages the~     existing organizational and environmental context of the workplace.~   "
89942|NCT01880047|"~     Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP~     there are some patients who have been reported as non responders at the maximal approved~     dose of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest~     and increasing response rate with increased doses of eltrombopag up to a dose of 75mg.~     Previously published data has shown no overt increase in toxicity in normal volunteers,~     oncology patients and aplastic anemia patients treated with escalated doses as high or~     higher than those proposed in this study.~      It therefore seems possible that in ITP patients who did not respond to a dose of 75mg~     daily, eltrombopag could be more effective at a higher dose. We propose a double blind~     randomized controlled trial in ITP patients who have been defined as non-responders at the~     maximum dose (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses~     (100mg, 125 mg, 150 mg)~   "
89943|NCT01880034|"~     Significant data exists to suggest that lipid emulsion administration in the setting of~     local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of~     potential barriers exist to routine lipid emulsion administration for those performing~     regional anesthesia including drug availability, drug cost and drug location. Inadequate~     training or lack of established protocols also have the potential to negatively impact~     patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United~     States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion~     availability on obstetric units and found that it was nearly universally available.~      The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact~     information for each anesthesia institution that engages in resident training. Investigators~     will contact these institutions by phone or email to obtain contact information for their~     regional anesthesia program director. In the absence of a program director, investigators~     will send a survey and consent information via email to the faculty physician most involved~     in regional anesthesia. Survey completion instructions (survey itself to be completed on~     Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the~     initial contact email. The study consent form will contain a description of the study~     itself. Survey participants will be allowed time to complete their survey in private at~     their discretion. Non-responders will receive two follow-up emails at one month intervals.~   "
89944|NCT01880021|"~     The purpose of this study is to determine whether synthetic hernia mesh materials undergo~     physical and/or chemical changes while in the body.~   "
89966|NCT01879735|"~     We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer~     11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and~     patients with cholestatic disorders.~   "
89946|NCT01879995|"~     The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural~     protein), and supplementation with a protein substitute (a mixture of amino acids free from~     phenylalanine, also containing micronutrients and vitamins) and special low-protein foods,~     to meet the patient's energy requirements. When diet and treatment is relaxed after~     childhood, adult and adolescent patients with phenylketonuria are at risk for malnutrition,~     depending on the compliance with treatment and the intake of amino acid supplements.~      In this study, nutrition status of patients with PKU and hyperphenylalaninemia is~     systematically assessed under ongoing current treatment, in relation to Phe-tolerance,~     compliance with treatment, and psychosocial issues.~      Study participants do not undergo any specific therapeutic or diagnostic intervention.~   "
89947|NCT01879982|"~     For the moment, the detection of a mood episode in Bipolar Disorder (BD) relies on the~     appearance of the first clinical signs that the clinician detect or that the patient becomes~     aware of and reports to the clinician. Since physiological parameters such as cardiac~     rhythms, respiratory rate, voice characteristics and actigraphy seem to be related to the~     onset of a mood episode, information collected through the combined monitoring of multiple~     selected physiological parameters (such as cardiac rhythms, respiratory rate, movements,~     voice) during wake and sleep time, using wearable user friendly systems included into~     garments as well as with a smartphone, may offer a new perspective in the long-term~     treatment of BD.~   "
89948|NCT01879969|"~     The specific aims of the study were to measure and compare the rates of alignment and cant~     reduction of the dental and facial midlines among the two groups.~   "
89949|NCT01879956|"~     Primary Objective:~      Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in~     improving executive functions in patients with refractory schizophrenia as measured by the~     BADS.~      Secondary Objectives: improvement of functional aspects,basic and instrumental activities of~     daily living,negative symptoms and cognitive functions improvement~      Hypothesis: OT is more effective than control group to improve executive functions in~     patients with refractory schizophrenia.~   "
89950|NCT01879943|"~     The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard~     colonoscopy in patients with prior colorectal surgery.~      The hypothesis is to validate the VCC as a means of screening for colonic polyps after~     resection, which would avoid a colonoscopy with its associated general anesthesia and~     potential side effects.~   "
89951|NCT01879930|"~     Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic~     pelvic pain, pressure or discomfort perceived to be related to the urinary bladder~     accompanied by at least one other urinary symptom such as persistent urgency or frequency in~     the absence of an identifiable cause. Chronic bladder pain syndrome severely decreases an~     individual's quality of life and represents a significant financial burden to those affected~     by it. Currently, multifactorial pathogenesis is assumed including endocrine-involvement,~     pelvic floor muscle irregularities, immunologic aspects and chemical causes. Corresponding~     to the wide spectrum of presumptive triggers, a large number of therapeutic approaches are~     propagated, however most are associated with limited effectiveness. Thus, treatment of BPS~     is a challenge and the ideal therapy remains to be elucidated. Microorganisms such as~     Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge~     so that these organisms may well be involved in the pathogenesis of chronic bladder pain~     syndrome. The investigators hypothesise that doxycycline orally for 4 weeks, including~     therapy of the sexual partner, can significantly relieve symptoms in women with chronic~     bladder pain syndrome~   "
89952|NCT01879917|"~     The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once~     daily compared to placebo for 52 weeks on change in beta-cell function in patients with~     newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.~   "
89953|NCT01879904|"~     Superficial rectal tumors could be removed by ESD with two major advantages showed by the~     literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was~     lower than ERM therapy. This technique is actually performed routinely in Japan and~     experience is limited in Europe, with few data in the literature.~      This study is suggested to patients with superficial medium or distal rectal tumors. The~     lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and~     chromoendoscopy. Then, marking around the lesions was performed. Local injection was made~     using injection needle, and then mucosal incision was performed around the lesion using~     endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel~     coagulation were practiced using primary hemostatic forceps during the procedure.~      Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement,~     undifferentiated, free margin less than 1 mm), a surgical resection is performed.~      All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with~     biopsies):~        -  For complete resection, an endoscopic control was performed at 1 year.~        -  For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic~          control was performed at 1 year.~      At one year, patient with incomplete resection have a surgical resection.~   "
89954|NCT01879891|"~     The primary goal is to test the hypothesis high interval exercise increases energy~     expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise~     cumulatively over 23 hours during and following the exercise. Secondary goals are to~     evaluate exercise difficulty during moderate intensity exercise and high interval exercise~     as well as difficulty of activities of daily living and free living physical activity~     following rest, moderate intensity exercise and high interval exercise.~      A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes~     in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be~     increased following the high intensity interval exercise. In addition, these changes will be~     related to changes in insulin sensitivity and increases in protein metabolism and muscle~     damage.~   "
89955|NCT01879878|"~     The goal of the POUDER trial is to determine the feasibility of a randomized controlled~     trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and~     quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative~     chemotherapy.~   "
89967|NCT01879722|"~     The purpose of this study is to characterize the safety and tolerability of TAK-063 when~     administered as multiple oral doses at escalating dose levels in participants with stable~     schizophrenia and in healthy Japanese participants.~   "
89956|NCT01879865|"~     Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for~     human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients~     remain arousable. This makes it an ideal drug for procedures which require the patient to~     perform tasks, or for light sedation during procedures or in the Intensive Care Unit.~     Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions~     (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There~     are several models available for dexmedetomidine at this time, but the most often used~     models (Dyck and Talke) underpredict the plasma concentration at higher concentrations.~     Also, plasma concentrations aren't what the clinician is interested in, but in the effect.~     Therefore, pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the~     drug to effect instead of plasma concentration, using TCI. This has been done for many~     anaesthetic drugs, but not for dexmedetomidine. Additionally, we want to investigate the~     effect of stimulation on the pharmacodynamic effect of dexmedetomidine. The reason for this~     is that patients under dexmedetomidine sedation are arousable by noises or touch. An~     operating room or ICU is never quiet, and there are always sounds of monitors, alarms, and~     talking between team members or activity around another patient in the same room, therefore~     the stimulation of the patient in such an environment may have a profound effect on the~     sedative effect of dexmedetomidine.~   "
89957|NCT01879852|"~     This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a~     traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits)~     of standard or quadriceps intensive rehabilitation. The objective of the study was to~     determine the effect of quadriceps intensive rehabilitation on knee function and articular~     cartilage.~   "
89958|NCT01879839|"~     The aim of this study is to assess the effect of a diet prior to administration of contrast~     agent in terms of a preventive procedure which leads to an attenuation of the~     contrast-induced nephropathy (CIN).~      Patients with a known kidney disease are especially at risk. A potential beneficial effect~     of a diet prior to intervention has been shown in investigations in mammals, therefore this~     study will investigate if a pre-interventional diet in patients with known kidney disease~     and scheduled contrast agent examination can attenuate or prevent a post-interventional loss~     of kidney function.~   "
89959|NCT01879826|"~     The purpose of this study is to test if treatment with laser therapy in pediatric patients~     undergoing renal biopsies will improve patient satisfaction of the overall procedure. In~     this study, the participant will receive a laser acupuncture treatment targeting either~     kidney acupoints or targeting sham points not associated with the kidney; the participant~     will not get both. Both treatment sessions are given by a certified medical acupuncturist.~     The patient will still receive standard pain control protocols with anesthetic medications~     like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain~     management after the procedure. All medication will be administered without regard for which~     group the participant has been randomized, as the treatment team will also be blinded.~      Hypothesis:~      We will test the hypothesis that treatment with laser acupuncture in patients undergoing~     renal biopsies will improve patient satisfaction of the overall procedure.~      Specific Aims:~      Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall~     satisfaction of renal biopsy.~      Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of~     sedative medication given during renal biopsy.~   "
89960|NCT01879813|"~     The study will explore the effects of a 6-week phospholipid drink intervention on the~     cognitive performance and physiological and subjective stress parameters of males following~     a repeated psychosocial/physical stressor.~   "
89961|NCT01879800|"~     The goal of this study is to 1) examine the feasibility and acceptability of a one-day~     Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients~     with comorbid vascular disease risk factors and depression or anxiety; and 2) to evaluate~     the effectiveness of this brief group intervention(ACT-IM), compared to Treatment-As-Usual~     (TAU) on the mental health and functioning of patients with co-morbid mood/anxiety and~     vascular disease risk factors. Patients with vascular disease risk factors will be~     identified by physicians in Family Practice or Internal Medicine, through chart review, or~     through advertisements. Those with vascular risk factors will be screened and assessed for~     symptoms of depression or anxiety. Patients who are experiencing significant depressive or~     anxiety symptoms and are interested in the treatment arm of the study will be randomized to~     the ACT-IM intervention or to TAU. Assessments of the following will take place both before~     and after the intervention: depression, anxiety, functioning, illness self-management, blood~     vessel health, and blood.~   "
89962|NCT01879787|"~     This study aims to evaluate systematically and controlled the effectiveness of mental~     practice techniques and modified constraint- induced movement therapy (mCIMT)in the~     treatment of post-stroke patients with motor deficit in the upper limb. As well as finding a~     protocol of transcranial direct current stimulation(tDCS)that will maximize the effects of~     the practice of mental image and mCIMT. To this end, the subjects included will be submitted~     to 12 therapy sessions with active or sham tDCS combined with at least one of the following~     techniques: conventional physiotherapy, mental practice technique or mCIMT~   "
89963|NCT01879774|"~     The aim of this epidemiological study is to characterize the neuropsychological and motoric~     performance in patients with hyponatremia. Newer studies revealed an association between~     mild hyponatremia and unstable walking, frequency of falls and risk of a fracture,~     questioning the paradigm of an asymptomatic hyponatremia. Until now, there is no known~     detailed investigation and characterisation of the cognitive and motoric performance or~     limitation by this disorder. Therefore this study will investigate patients with~     hyponatremia on the basis of neuropsychological and neurological tests.~   "
89964|NCT01879761|"~     The purpose of this study is to determine how monocyte HLA-DR and other markers of immune~     function change with time in patients with and without prior immune dysfunction who survive~     sepsis from Staphylococcus aureus bacteremia.~      We hypothesize that patients with prior immune dysfunction will have greater reductions in~     HLA-DR and other markers of immune function after an episode of sepsis than people who do~     not have prior immune dysfunction.~   "
89965|NCT01879748|"~     This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese~     and Caucasian subjects after single and multiple doses of rasagiline.~   "
89968|NCT01879709|"~     Cognitive impairment is a key disabling feature of SZ. The impairment affects functional~     outcome and employability, resulting in increased burden. Currently, medications offer only~     modest benefits for the cognitive dysfunction. Hence, non-pharmacological interventions are~     worth consideration. Yoga is known to enhance cognitive abilities in healthy persons. Our~     preliminary studies have shown for the first time that there may be remarkable improvement~     in selected cognitive domains among outpatients with SZ. The improvement is unlikely to be~     due to rater bias, as they were noted using a computerized neurocognitive battery. Since our~     preliminary studies involved an open trial, it is necessary to conduct more controlled~     studies. To evaluate our results further, we propose to test the effectiveness of yoga~     supplementation using a controlled single blind design in India. Outpatients with SZ (N=258)~     undergoing treatment at a large academic center in New Delhi, India will be randomly~     assigned to one of the three groups- yoga training (YT, N=86), physical exercise (PE, N=86)~     or treatment as usual (TAU, N=86). The YT group will undergo 21 days yoga supplementation,~     while the PE group will complete a 21 day systematic physical exercise training regime. The~     third group will have no such supplementation. Cognitive state, symptom severity and overall~     function will be assessed at four time points: just before, immediately after, three months~     later and six months after completion of YT/PE supplementation. The evaluations will be~     conducted by raters blind to group status.~      Hypotheses:~        1. Yoga enhances attention, as well as related cognitive function among persons with~          schizophrenia.~        2. Yoga has beneficial effects on the short term functional outcome of schizophrenia~   "
89969|NCT01879696|"~     The proposed study is a double-blinded, randomized clinical trial of tissue pressure~     monitoring only (Control group) vs. tissue pressure monitoring plus tissue ultrafiltration~     (Treatment group) in patients with tibia fractures presenting to the trauma or emergency~     departments at participating clinical sites. Tissue ultrafiltration refers to the removal of~     muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to~     demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters~     decrease the incidence of fasciotomy in the Treatment group when compared to the Control~     group. Fasciotomy was chosen as the primary outcome because it is clearly defined and~     clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients~     may have isolated tibia fractures OR be multiple trauma patients (those with another major~     fracture in a different body region or two distinct body system injuries, excluding those~     with injuries to the opposite leg that would preclude them from completing required tests).~   "
89970|NCT01879683|"~     The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when~     administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any~     change in the bladder or in IC symptoms, following LiRIS administration.~   "
89971|NCT01879670|"~     Heart failure is a common condition, and the number of people with advanced disease~     continues to increase. We need new treatments that improve patients' symptoms and extend~     life. Recently the new CircuLite Synergy pump has come into use. It is the smallest pump~     manufactured to date and does not cover the full work of the heart, instead providing~     partial support. One interesting thing about this is that taking some strain off the heart~     might allow the muscle to repair and rebuild its own strength. This process is called~     reverse remodelling, and is the topic of this research. Our hypothesis is that partial~     support improves patients' symptoms and causes improvement in heart muscle function. We also~     want to examine the best techniques for assessing this, including new scanning and molecular~     tests, and study some practical aspects of the pump to do with blood clotting.~   "
89972|NCT01879657|"~     To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and~     OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers~     and other imaging modalities like CT scan/MRI as gold standard.~   "
89973|NCT01879644|"~     Neurofeedback has proved to be effective in treating Attention deficit hyperactivity~     disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can~     be used as a therapeutic intervention in regular outpatient care. The investigators compare~     high frequent neurofeedback with high frequent self-management therapy and suppose that both~     result in comparable effects.~   "
89974|NCT01879631|"~     Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a~     conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening~     effect. It can also halt the progression of disease owing to fibrotic activation in~     perpendicular corneal incisions.~   "
89975|NCT01879618|"~     The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of~     patients during dialysis.~   "
89976|NCT01879605|"~     This study investigated the effect of preoperative bowel preparations for patients~     undergoing spinal fusion surgery.~   "
89977|NCT01879592|"~     Asthma and sickle cell disease each are serious medical problems. People with asthma have~     difficulty breathing, wheeze (a whistling noise when breathing), cough, produce sputum or~     phlegm, and have inflammation (swelling, irritation, redness) and narrowing of the bronchial~     tubes.~      When a person has both asthma and sickle cell disease together, more serious medical~     problems can occur such as having acute chest syndrome and pain episodes more often. It is~     sometimes hard to diagnose asthma in a person with sickle cell disease because sickle cell~     disease can also cause lung problems.~      The purpose of this study is to see if the investigators can better understand asthma when~     it occurs in a person who has sickle cell disease. The investigators will do this by taking~     a blood, urine, and saliva sample. The blood and urine samples will be analyzed for~     chemicals and DNA (genes). Certain genes can cause patients to have sickle cell disease or~     asthma. The investigators will use the saliva sample for future studies to compare the~     results from the blood testing with saliva. The investigator's long-term goal is to make~     sure people who have asthma and sickle cell disease are getting the best asthma treatments.~     The investigator's hypothesis is that the analysis of the blood, urine and saliva using a~     method called, metabolomics, may identify a unique asthma signature in children with sickle~     cell disease which may lead to targeted treatments.~   "
89978|NCT01879579|"~     The purpose of this pilot study is to determine whether text message (and phone)~     communication can be effectively utilized to adjust long-acting insulin, compared to~     standard practice.~   "
92184|NCT01849601|"~     The purpose of this study is to determine whether the peripheral balloon dilatation catheter~     (trade name: Iris) is safe an effective in PTA procedure.~   "
89979|NCT01879566|"~     The aim of this prospective single-center study is to evaluate sympathetic nervous system~     directly measured by microneurography, 24-hour blood pressure, endothelial function,~     vascular compliance, quality of life and platelet adhesion in patients with sleep apnea~     syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness~     score>8[10], and an apnea/hypopnea index (AHI>15/h) before and after catheter-based~     radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this~     therapy should be stable during the whole study time. Primary and secondary end-point will~     be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.~   "
89980|NCT01879553|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.~      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will~     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI)~     at approximately 21 days post vaccination.~      The vaccine composition will be based on the WHO-recommended influenza strains for the~     2013/2014 Northern Hemisphere vaccine, and the results of this study are intended to support~     the use of this vaccine in future influenza seasons if the recommended vaccine composition~     remains the same, in compliance with the requirements of the current European Union (EU)~     recommendations for clinical trials related to yearly licensing of influenza vaccines.~   "
89981|NCT01879540|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014~     Northern Hemisphere, in adults ≥65 years of age.~      For the immunogenicity endpoints the antibody response to each influenza vaccine antigen,~     will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition~     (HI) at approximately 21 days post immunization.~      The vaccine composition will be based on the World Health Organization (WHO) recommended~     influenza strains for 2013/2014 Northern Hemisphere.~      The results of this study are intended to support the use of this vaccine in future~     influenza seasons if the recommended vaccine composition remains the same, in compliance~     with the requirements of the current European Union (EU) recommendations for clinical trials~     related to yearly licensing of influenza vaccines.~   "
89982|NCT01879527|"~     Following acute inflammation of the optic nerve region, as commonly seen in multiple~     sclerosis patients, the optic nerve often undergoes atrophy, thus representing permanent~     damage. Data from animal studies suggest that amiloride may prevent this process. The aim of~     this study is to assess a potential neuroprotective effect of amiloride in acute autoimmune~     inflammation of the optic nerve region.~   "
89983|NCT01879514|"~     IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary~     nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most~     main primary renal disease,could cause the uremia. It will be significant that early~     indicators of prognosis and early intervention can be normalized and the scientific criteria~     for judging the efficacy of great clinical can be established. The subject based on the past~     study,literature research and various treatment will take the method of multi-center,~     double-blind, randomized, control to investigate the standard treatment of severe IgA~     nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM)~     will be improved by the standardization of TCM research based on the epidemiological~     investigation and statistical analysis. The subject will determine the efficacy of more~     sensitive biomarkers and establish more scientific criteria for judging the effect with the~     application of urine proteomics and metabolomics technologies in order to operate in the~     formation of the standardization program of the treatment of severe IgA nephropathy with the~     Integrative medicine of TCM.~   "
89984|NCT01879501|"~     The need for low vision services (LVS) will increase exponentially over the coming years due~     to the anticipated and exponential growth in the ageing population in Singapore and a rise~     in chronic non-communicable eye diseases. Finding the best evidenced-based management for~     chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient~     responsibility is the key to managing LV effectively.1 This means achieving optimum self~     management (SM).2 However, there are currently no LV SM programs in Singapore and none has~     been evaluated using a randomized controlled trial (RCT) design, the gold standard methods~     to evaluate health interventions.~      The aims of this study are to assess the effectiveness of the 'Living Successfully with Low~     Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV~     attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly~     allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the~     usual care. Comparisons will be made to determine the efficacy of the LSLV program. QoL,~     self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks~     after training, and at six months and 12 months post intervention.~      This study will be the first evidenced-based RCT investigating the effectiveness of a novel~     vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal~     design where the effectiveness of these interventions will be evaluated at 12 months-the~     first follow-up assessment of that duration at both national and international levels.~     Furthermore this will be the first study to characterize and profile the patients where the~     effect of the program did not demonstrate an improvement in both primary and secondary~     outcomes six months after its completion. The future clinical implications of this study~     include the potential to implement a successful model of LV rehabilitation in other tertiary~     centres around the country.~   "
89985|NCT01879488|"~     Controlling the respiratory pattern of mechanically ventilated patients in volume control~     mode is recommended during nebulization. No studies looked into conditions of nebulization~     during assisted mechanical ventilation to define the optimal nebulization technique and its~     effect on pulmonary deposition.~      The aim of this study is to analyse the effect of ventilation mode (barometric versus~     volumetric) on deposition by planar scintigraphy during mechanical ventilation.~   "
89986|NCT01879475|"~     The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to~     Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac~     and aortic thoracic surgery.~   "
89987|NCT01879462|"~     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the~     treatment of chronic HCV infection. This study represents the first administration of~     GSK2878175 in humans to define safety, tolerability, and pharmacokinetics (PK) following~     single and repeat doses of GSK2878175 in healthy subjects.~      This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to~     determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and~     repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of~     a moderate (30%) fat meal on single dose PK endpoints in healthy subjects.~   "
91611|NCT01858077|"~     To evaluate the efficacy and performance in an all-comers contemporary population of the~     ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE~     PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of~     coronary lesions.~   "
89989|NCT01879436|"~     Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies.~     Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational~     hormones and pregnancy-related growth factors may induce a more aggressive behavior in~     malignant cells. However, metastasis to the products of conception is rare. In the current~     study investigators wish to analyze the effect of placental explants on cancer cells~     (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death,~     proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.~   "
89990|NCT01879423|"~     This is a single dose, open-label, randomized, two-period crossover study to demonstrate the~     bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine~     compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. The~     safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets~     will also be assessed.~   "
89991|NCT01879410|"~     Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used~     for the treatment of airflow obstruction in patients with COPD. Fluticasone~     propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of~     COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to~     evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram [mcg] once daily administered~     via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC)~     250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment~     period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to~     UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be~     conducted approximately 7 days after the end of the study treatment.~   "
89992|NCT01879397|"~     Pilot prospective two cohort observational study to create a model of the carotid plaque~     composition based on ultrasonic backscattered signals and select clinical data.~   "
89993|NCT01879384|"~     Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps.~     Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they~     all described the position of the catheter in the surrounding soft tissue muscle. This~     surrounding soft tissue is not always the reflect of bone vascularisation.~      The aim is to study the feasibility of a follow up of microanastomosed bone flaps with~     microdialysis. To reach this goal, investigators perform a clinical prospective research~     project untitled MTM project~   "
89994|NCT01879371|"~     To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of~     ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen~     lysinate (Nurofen Immedia®).~   "
89995|NCT01879358|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is~     to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the~     biolimus-eluting NOBORI stent in a population-based setting, using registry detection of~     clinically driven events~   "
89996|NCT01879345|"~     Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of~     BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male~     volunteers~   "
89997|NCT01879332|"~     Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to~     determine a maximum tolerated dose~   "
89998|NCT01879319|"~     The primary objective of this study was to assess users' ability to administer a full dose~     of evolocumab in a home-use setting using either an automated mini-doser (AMD) or~     autoinjector/pen (AI/pen).~   "
89999|NCT01879293|"~     Cardiovascular disease is the most common cause of death in the world. Most of the attention~     in treating ischemic heart disease (IHD) is understandably directed toward treating coronary~     artery disease. However there are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of~     hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In~     one study, the presence of LVH was a stronger predictor of mortality than either multivessel~     cor-onary disease or impaired LV function.~      Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes.~     In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a~     39% lower risk of myocardial infarction compared with conventional therapy. Metformin also~     offered dual benefits of improving vascular function and lessening ischemia in nondiabetic~     patients.~      Hence, the main aim of this study was to assess whether metformin could regress LVM in~     patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and~     endothelial function in this patient group.~   "
90000|NCT01879280|"~     The scientific objectives of this study are to systematically study the problems that are~     created by incising the attachment of the temporalis muscle in a randomized group of~     patients, and to determine whether another approach that does not detach the temporalis~     muscle results in less post-operative morbidity. Cutting through the attachment of the~     temporalis muscle to the skull is a widely-accepted procedure used to gain access to the~     skull prior to the drilling used for a pterional craniotomy (one of the most frequent types~     of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and~     the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain,~     temporalis weakness, and pain with mastication), very little is known about the true~     incidence of these post-operative symptoms. Furthermore, there is very little objective~     evidence at the present time to support the claim that the incidence and severity of these~     post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a~     procedure where the temporalis is left attached to the bony calvarium). The investigators~     would like to evaluate whether this slightly more time-consuming and technically demanding~     approach is less morbid in this respect than the contemporary pterional approach. Special~     note is made that the osteoplastic approach has been used in standard neurosurgical practice~     for quite some time.~   "
90089|NCT01878110|"~     This pilot study is being conducted in order to help make the case for later, more~     systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of~     treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB~     treatment techniques in the form of a clear written manual for therapists; determine whether~     therapists can use these guidelines in a consistent manner in making treatment decisions;~     develop and test the reliability of measures of how well therapists are conducting the~     treatment; and collect preliminary data on the acceptability of the treatment to patients.~   "
90001|NCT01879267|"~     Huntington's disease (HD) is an incurable and fatal disorder characterised by progressive~     degeneration of the basal ganglia and the cerebral cortex. Contrary to earlier thinking, HD~     is associated with abnormalities in peripheral tissues which might even contribute to brain~     pathology including muscle wasting, mitochondrial abnormalities, and impaired muscle energy~     metabolism. Mitochondrial impairment and muscle atrophy in human HD patients and murine~     models of HD are associated with altered expression of PGC-1a, a transcriptional cofactor~     that seems to regulate many, if not all of the adaptations of muscle fibres to chronic~     endurance training, and induces improved exercise performance and increased peak oxygen~     uptake. We aim at investigating whether endurance exercise has the capability of stabilizing~     and / or reversing PGC-1a dependent alterations of muscle function and structure in HD~     patients, and whether muscle training ameliorates musculoskeletal and cardiovascular~     function, as well as motor and cognitive symptoms in HD patients.~   "
90002|NCT01879254|"~     For this human research, 17 treatment-refractory OCD patients who already received DBS~     implants for treatment refractory OCD between June 1998 and October 2007 will be included.~     New patients that complete the protocol on refining the target for DBS in OCD will be~     included in this follow-up study as well. They will be psychiatrically evaluated on regular~     bases: at least twice yearly in the years two to five after surgery, at least once a year~     for the years thereafter. The duration of this protocol is indefinite, but spans at least 10~     years. The main aim of this study is to investigate the long-term effect of DBS in OCD~     patients.~   "
90003|NCT01879241|"~     The primary objective of the trial is to investigate the survival time (the time from~     randomization until death or end of the trial) compared between control group and~     experimental group.~      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind~     trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in~     amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial~     Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole~     at least 4 weeks prior to randomization.~   "
90004|NCT01879228|"~     In recent years, diabetes has emerged as one of the most significant co-diseases that many~     Cystic Fibrosis (CF) patients develop. Type 1 and Type 2 diabetes results when either the~     body does not make enough insulin or the body does not respond correctly to this insulin.~     Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar)~     from the food we eat to the cells of the body for energy. While cystic fibrosis related~     diabetes (CFRD) has many features similar to both Type 1 and Type 2 diabetes, it is very~     different; therefore, treatment and care of CFRD is not the same.~      The purpose of this research study is to examine and understand the various mechanisms that~     contribute to CFRD and gain a better understanding of potential means to treat CFRD. The~     primary objective is to determine effectiveness of chronic incretin-based therapy vs.~     placebo on insulin secretion in CF patients with indeterminate glucose tolerance, impaired~     glucose tolerance, or CFRD.~   "
90005|NCT01879215|"~     This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on~     patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs.~     the suprapatellar approach. Subjects will be randomized to one or the other standard care~     surgical approaches.~   "
90006|NCT01879202|"~     Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical~     and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available~     therapy is limited. The goal of this study is to determine whether MS-associated fatigue~     improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a~     questionnaire called Fatigue Severity Scale (FSS).~   "
90007|NCT01879189|"~     In order to better communicate personal risk of breast cancer to women who have not yet~     initiated breast cancer screening (mammography), The Annenberg School of Communication at~     the University of Pennsylvania has created a personal breast cancer screening decision aid~     tool. This tool will be pilot tested, and then implemented and tested in nine primary care~     and OB/GYN practices within the University of Pennsylvania Health System.~   "
90008|NCT01879176|"~     Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by~     extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,~     endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,~     ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in~     systemic inflammation and the main producers of pro- and antiinflammatory cytokines.~     Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory~     homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6~     and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory~     response induces post surgical monocyte immunosuppression which is indicated by an impaired~     production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral~     circulation with increased lactate levels, pronounced fluid accumulation, increased need of~     vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning~     from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to~     decrease the inflammatory process have the potential to improve the perioperative course.~      Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels~     for the first 36 hours after surgery and induces a decreased inflammatory response for up to~     3 days post surgery.~   "
90009|NCT01879163|"~     This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313~     vaccination compared to MVA85A vaccination, in BCG vaccinated adults.~   "
90010|NCT01879150|"~     Single center, open-label, single arm, pilot study designed to evaluate safety, tolerability~     and efficacy of CYCLAPLEX device, a minimal invasive enhanced suture and button implant and~     surgery tools for correction of inter-metatarsal angle in subjects suffering from mild to~     moderate Hallux Valgus deformity~   "
90011|NCT01879137|"~     the purpose of the study is to investigate whether arginine infusion is a new tool to~     differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.~   "
90012|NCT01879124|"~     The purpose of this study is to evaluate the prognostic performance of intrarenal resistive~     index in the first years after kidney transplantation on graft function and on patient and~     graft survival. In addition, the determinants of the intrarenal resistive index, including a~     detailed analysis of the relation between graft histology and the intrarenal resistive~     index, will be assessed.~   "
90013|NCT01879111|"~     Out-patients with coronary heart disease or hypertension will fill out a depression~     screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled~     study design half of the patients will receive a patient-targeted written screening~     feedback. This feedback contains information about depression in general,~     depression-severity adapted treatment guidelines and contact-information for treatment.~     Patients in the control group receive no direct screening-feedback but their cardiologist~     will be informed about the screening result. All patients with a positive screening-result~     will be contacted after one month and six months and asked for symptoms of depression, and~     their use of health care. The aim of this study is to evaluate the efficiency of this~     minimal intervention on the course of depressive symptom in patients with known coronary~     heart disease or hypertension.~   "
90014|NCT01879098|"~     The purpose of this research study is to determine whether a probiotic can change the way~     bile is used by the body. The investigators will also look at the effect of the probiotic on~     your intestinal health.~   "
90015|NCT01879085|"~     This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study~     designed to determine the safety, tolerability, and recommended dose of the combination.~      During the Phase 2 portion of the study, we will assess progression-free survival (PFS),~     overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation~     measured by microarray, and expression level of the genes as measured by microarray~   "
90016|NCT01879072|"~     The goal of this protocol is to establish a cohort of at least 1500 biologic samples~     collected prospectively from patients treated in BMT CTN centers that will be a shared bio~     specimen resource for conducting future allogeneic hematopoietic stem cell transplantation~     (HCT) correlative studies.~   "
90017|NCT01879059|"~     The effects of physical inactivity on variations in blood glucose and vascular health are~     not fully understood. The purpose of this study is to determine if an acute transition from~     physical activity to inactivity alters vascular health. Specifically, the investigators wish~     to examine in healthy, lean physically active individuals (obtaining greater than 10,000~     steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter~     blood flow following a meal a marker of vascular health. Furthermore, the investigators wish~     to examine if a one day return to physical activity (obtaining >10,000 steps/day) can~     restore the detrimental effects on blood flow following a meal.~   "
90018|NCT01879046|"~     Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic~     defaults. The cartilage has no intrinsic ability to repair resulting at long term in~     function loss in the joints. Currently available treatments are not satisfactory in the long~     term, the use of mesenchymal stem cells appears to be promising due to their ability to~     multipotency and immunomodulation properties. This project aims to determine the most~     appropriate source for regenerative medicine of cartilage stem cells from tissue taken~     during arthroplasty in patients with osteoarthritis. These cells will be tested for~     different chondrogenic markers. The success of this project will consider the implementation~     of a strategy for regenerative medicine in bone and joint diseases.~   "
90019|NCT01879033|"~     Childhood obesity is perhaps the most significant public health problem in the most~     developed countries and is rapidly becoming so in developing countries. National Health and~     Nutrition Examination Survey data shows a 3-fold increase in the prevalence of obesity in~     childhood, over past few decades. Furthermore, childhood obesity has markedly contributed to~     the prevalence of the metabolic syndrome and type 2 diabetes in U.S. children. Alarmingly,~     there is increasing evidence that atherosclerosis develops silently during childhood in~     obese children. In the Bogalusa Heart Study, pediatric autopsy studies showed a clear~     relationship between the number and severity of risk factors, principally obesity, with~     atherosclerosis in both the aorta and coronary arteries. Increased intimal medial thickness~     (IMT) was not present among obese adults who had been normal weight as children, emphasizing~     the cumulative effects of childhood obesity persisting into adulthood. Thus, the need for~     primary prevention of cardiovascular disease beginning in childhood is strongly suggested.~   "
90020|NCT01879020|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects~   "
90021|NCT01879007|"~     This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous~     Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation~     (Gemifloxacin 320mg) and to explore possibility of clinical use of the IV formulation.~   "
90022|NCT01878994|"~     Objectives: To evaluate the effectiveness of the Nereu program compared to standard care~     (advice on increased physical activity and nutrition) such as a health intervention tool for~     the childhood obesity management~      Methods/Design: The study design is a randomized controlled multicenter clinical trial using~     two types of treatment. Population and sample: Children 6 to 12 years with overweight or~     obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined~     by International Obesity Task Force (IOTF). It is considered necessary to recruit 100~     children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8~     month intervention with 3 weekly training sessions doing physical exercise for children and~     a weekly session for parents of physical activity and healthy eating habits and behaviour~     strategies, that involves both parental and child participation. The control group will~     receive a monthly session of healthy physical and eating habits. Main Outcome Measures:~     Improvement of BMI z, physical activity and nutrition habits, behaviour components and~     quality life related to health at the end, 6 and 12 months after intervention.~   "
90023|NCT01878981|"~     To generate real world evidence to compare clinical outcomes and patient health-related~     quality of life, resulting from catheter ablation therapy with clinical outcome and patient~     health-related quality of life resulting from drug therapy in China. An economic model will~     be constructed, and using the clinical events evidence collected in this study, and China~     long-term disease progression and local disease cost data to perform a cost-effectiveness~     evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF)~     patients.~   "
90024|NCT01878968|"~     There is evidence to suggest that patients make different end-of-life decisions if they~     understand the risks, benefits and alternatives of CPR and mechanical ventilation. This~     study will examine whether evidence-based informed consent impacts patients choices and~     healthcare outcomes compared to routine care.~   "
90025|NCT01878955|"~     AMH is a member of the transforming growth factor family. It is produced by the granulosa~     cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the~     antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and~     follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic~     ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in~     patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown.~     There are data showing elevated serum AMH level is due to the increase in the number of~     follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian~     is defined by the presence of more than six follicles 4-9 mm in diameter and mixed~     morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of~     the increase in stroma / volume.The aim of this study is to investigate whether there is a~     difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary~     goal is to investigate the usability of AMH as a marker besides ultrasound for~     discrimination of nonhyperandrogenic patients with PCO or multicystic ovaries.~   "
90026|NCT01878942|"~     The purpose of this study is to characterize the acute psychological, physiological,~     endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.~   "
90027|NCT01878929|"~     Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality~     for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which~     a patient receives frequent, escalating doses of the allergens they are allergic to until~     they reach a predetermined maintenance dose. This is followed by a maintenance phase during~     which the allergen dose is kept constant and administered at greater intervals. Maximum~     clinical improvement is generally not seen until a patient is in the maintenance phase.~     Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen~     season has led to dosage freezes during a patient's pollen season which extends the length~     of the build-up phase by many months. Prolonging the buildup phase increases the time~     required to obtain maximal benefit from SCIT, and at the same time, can decrease patient~     compliance with therapy due to the prolonged period of time when frequent injections are~     required.~      The aims of this study are to determine if adverse reactions to pollen SCIT are increased if~     doses are increased during pollen season.~   "
90028|NCT01878916|"~     Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in~     myeloproliferative neoplasms (MPNs) than the normal population. In this study, we~     investigated the thrombosis incidence, the effects of plasma homocysteine levels on~     thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine~     levels in MPNs, and to compare these results with the healthy controls.~   "
90029|NCT01878903|"~     When assessing acute post-operative pain, the validity, reproducibility and reliability of~     Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated~     extensively. The use of electronic version of VAS has been published in the recent 10 years~     yet publication related to its use in pain medicine were few. Jamison et al have shown good~     correlation between electronic VAS vs paper VAS on healthy volunteers using weight as the~     stimulus. In normal subjects as well as fibromyalgia patients, electronic form of VAS could~     be used to describe different levels of experimental heat stimulation.~      Long term study had been done where electronic pain diary were compared against paper diary~     in recording pain in 36 patients with chronic low back pain. The 2 scales showed good~     correlation. This author use a software that is Palm-top computer based. Following these few~     studies, validation study in chronic pain patient were published. A Palm-top computer based~     VAS was compared with paper NRS in 200 chronic pain patients. The pain level recorded by the~     two methods were considered equivalent by the author. However, Palm-top computer has almost~     disappeared from the market nowadays.~      Recent handheld electronic devices (iPad®) were incorporated with touch screen input~     interface which allow users to use their finger as the input device. To our knowledge, there~     is no published data concerning iPad-based VAS, especially in post-operative pain. We would~     like to compare the data obtained from electronic VAS on iPad with verbal numerical rating~     scale when acute post-operative pain is assessed.~      Hypothesis The null hypothesis is that the two pain measurement method do not correlate. The~     Spearman correlation coefficient between electronic VAS and verbal NRS will be reported.~   "
90030|NCT01878890|"~     Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal~     resistant prostate cancer lead us to continue clinical development of efavirenz.~     Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study~     with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients~     with cancer in order to determine the maximum tolerated dose to improve therapeutic effect.~      This study is a single center Phase I trial, conduct with dose escalation scheme of~     efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except~     pancreatic cancer) and non-Hodgkin lymphoma (NHL).~      Main objective is to determine the safety profile, and particularly the maximum tolerated~     dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer)~     or NHL in therapeutic failure.~      Secondary objectives are:~        -  Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;~        -  Evaluate objective response at 12 weeks;~        -  Evaluate progression free survival at 6 months;~        -  Assess biological progression-free survival at 6 months (prostate tumours only).~      Primary Endpoint~      Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting~     toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of~     Efavirenz and will be defined as follows:~        -  Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia,~          nausea and vomiting, regardless of grade),~        -  Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days,~        -  Score ≥ 19 HAD during treatment. Secondary Criteria~        -  Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC~          2009).~        -  Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria~          [Cheson BD et al. JCO 1999]~        -  Biological progression (particular case of prostate tumors): defined according to Scher~          [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation~          strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al.~          Biometrics 1996] and commonly used in Phase I trials in oncology.~        -  Maximum number of eligible and evaluable subjects is 30.~        -  Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000~          mg.~        -  The risk of dose limiting toxicities maximum allowed is 25%.~   "
90085|NCT01878162|"~     Law enforcement officials (LEOs) demonstrate an elevated risk for occupational injury. The~     effectiveness of exercise-based work injury prevention programs (WIPPs) to reduce the risk~     and costs associated with occupational injury has yet to be tested rigorously in LEOs. The~     accuracy of existing field tests of physical functioning to predict occupational injuries~     and related expenses remains unclear. The objectives of this study are to: (i) determine the~     effect of an exercise-based WIPP on occupational wellness and productivity in a cohort of~     LEOs, and (ii) to determine the accuracy of 2 common field assessments of physical function~     to predict lost work productivity and related expenses in a cohort of LEOs.~   "
90031|NCT01878877|"~     Background Chronic pain is one of the major health problems among Western countries. It is~     also one of the most frequent reasons for seeking medical care. Chronic pain is also an~     important problem in Hong Kong. A study conducted in our institution in 2002 discovered that~     the prevalence of chronic pain among Hong Kong adult population was 10.8%. This is expected~     to be higher after a decade as the population is aging because old age is one of the risk~     factors of chronic pain.~      The changes in prevalence, pattern, severity and help seeking behavior should be explored in~     order to evaluate the attitude toward chronic pain and the efficacy of chronic pain~     treatment. A local study reported the prevalence of chronic pain in 2007 in Hong Kong was as~     high as 34.9%. The reported rate was much higher than that of Ng et al. However, the~     difference in methodology produced different results even though they were done in the same~     population, which make the comparison difficult. Besides, the treatment efficacy and help~     seeking behavior were not studied in this study. The differences in mode of data collection,~     the wording of the questionnaire and the grouping of categories also influence the results~     of the study. It is also desirable to have the update information of chronic pain in Hong~     Kong regularly (i.e. every 5 years) in view of the rapid increase in prevalence of chronic~     pain in Hong Kong.~      To compare the changes in chronic pain prevalence and related outcomes, this study design is~     similar to the previous study done in our institution in 2002. The definition of chronic~     pain is the same as the previous study, which is pain persistence for 3 months or more. The~     mode of conducting the interview and the questionnaire used will be grossly similar to the~     previous study. Because chronic neuropathic pain is common and sometimes difficult to be~     managed, questions about the incidence of chronic neuropathic pain will also be sought. This~     important information has not been reported in Hong Kong before. The purpose of this study~     is to obtain the update cross-sectional prevalence and demographic information of chronic~     pain among Hong Kong adult population. The data will be compared with a similar study 4 done~     10 years ago at our center in order to assess the change of chronic pain over the past~     decade. Treatment seeking preference will also be assessed. We hypothesize that the~     prevalence of chronic pain is increased when compare that of a decade ago.~   "
90032|NCT01878864|"~     A randomised cross-over study comparing two methods of local anaesthesia for patients~     diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be~     included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is~     non-inferior to lidocaine-adrenalin injections.~   "
90033|NCT01878851|"~     Following medical history and clinical examination the children which are scheduled for~     treatment with suspected pulpary involved primary teeth will be selected. During the regular~     treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is~     performed the blood that is flowing out of the pulp will be collected and stored until~     analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will~     be obtained in follow up appointments if the child will remain in regular treatments in our~     clinic.~   "
90034|NCT01878838|"~     This study compares two FDA approved Cataract Lasers.~   "
90035|NCT01878825|"~     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of~     Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults~     aged 18 years and older.~   "
90036|NCT01878812|"~     The purpose of this study is to assess, in adults 18 years of age and above, the~     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit~     Tetra containing the four influenza strains (two A strains and two B strains) for the~     2013/2014 season.~   "
90037|NCT01878799|"~     Background:~      - Present treatment for hepatitis C includes the use of a weekly injection and two different~     pills. This treatment is associated with serious side effects. Drugs that can be taken by~     mouth and cure HCV infection without serious side effects would be a great help to the large~     number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed~     to treat the hepatitis C virus (HCV) infection. They are still being researched and are not~     approved by the Food and Drug Administration. They are being developed as treatment for~     hepatitis C as a single pill taken once a day.~      Objectives:~      - To determine whether a combination of the two study drugs can safely and effectively treat~     HCV infection in people with HIV infection and who do not have cirrhosis of the liver.~      Eligibility:~      - Individuals who have HIV infection and have liver disease caused by infection with HCV.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Urine samples will be collected from participants who might become~          pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be~          required.~        -  Participants will take one pill daily for 12 weeks. This pill will be a combination of~          the two study drugs.~        -  Treatment will be monitored with frequent clinic visits and blood tests over a total of~          60 weeks.~   "
90038|NCT01878786|"~     The purpose of this pilot study is to evaluate concentration-controlled everolimus with low~     dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard~     dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus~     and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States,~     comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment~     regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of~     donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is~     necessary.~   "
90039|NCT01878773|"~     This study will look at how feasible it is to use a certain type of Computed Tomography (CT)~     to scan prostate cancer, called a high quality volume CT scan. It is hoped that this~     technique will help doctors provide a higher-quality image of the prostate cancer, making it~     easier to plan the area that will be treated. Using this type of CT scan will also lessen~     the amount of time patients spend in the scanner.~      This study will not offer patients a different treatment for their prostate cancer. Patients~     will receive the most appropriate standard treatment whether or not they are in this study.~   "
90040|NCT01878760|"~     The aims of the APRICOT study are:~        -  To establish the incidence of severe critical events in children undergoing anesthesia~          in Europe.~        -  To describe the differences in paediatric anaesthesia practice throughout Europe.~        -  To study the potential impact of this variability on the occurrence of severe critical~          events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis,~          Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and~          postanaesthetic Stridor).~   "
90086|NCT01878149|"~     The purpose of this retrospective clinical evaluation is to compare VEO® single or~     multilevel results to XLIF® single or multilevel results relative to the safety endpoints.~     This study will collect retrospective data on subjects who were treated with VEO® and XLIF®~     at least 3 months prior to the initiation of this study. Given that fusion generally takes~     at least 6 months to determine, the aim of this study is not to determine fusion but to~     consider the short-term (out to 6 months) reported adverse events between the two cohorts.~      Devices used in both systems are cleared for use and conform to US regulatory requirements.~     The study employs these procedures and devices for uses that are consistent with their~     510(k), legally cleared, labeling.~   "
90041|NCT01878747|"~     The goal of this randomized trial is to examine the effectiveness of a Provider Tailored~     Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the~     recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers~     (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly~     developed intervention, or a Control Group who will receive a 2-hour seminar on the~     management of preoperative anxiety and postoperative pain and otherwise will provide~     standard care. The aims of this study are to:~      PRIMARY AIM~      1. Determine if P-TIPS is more effective than standard care for preventing high preoperative~     anxiety among children undergoing anesthesia and surgery. The primary outcome will be~     observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale~     Preoperative Anxiety Scale).~      SECONDARY AIMS~        1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative~          pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive~          behavioral changes as measured by the PAED, and PHBQ~        2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores~          in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires~        3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired~          behaviors as compared to control group and whether these behaviors mediate the child~          and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS~   "
90042|NCT01878734|"~     Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the~     government due to its major contribution to morbidity and mortality among children,~     especially infants in their formative years. One of the most successful, cost-effective, and~     recommended strategy to address micronutrient malnutrition is 'in-home fortification' with~     micronutrient powders (Sprinkles being the most widely recognized) along with nutrition~     education. While this intervention has proven to be safe, effective, and efficacious in~     numerous other countries, a specific national protocol must be developed to maximize its~     effect on reducing anaemia in Zambian children. The proposed research aims to inform such~     protocol.~   "
90043|NCT01878721|"~     The purpose of this study is to evaluate the value of positron emission tomography/computed~     tomography in various inflammatory conditions caused by bacterial infection or vasculitis.~     Glucose analog FDG is sensitive to detect inflammation foci but we hypothesize that other~     imaging agents such as PK11195 and Ga-citrate may have added value in certain applications.~   "
90044|NCT01878708|"~     This is an open-label, single-arm pilot study of Oncaspar® with dexamethasone for patients~     with relapsed or refractory peripheral T-cell lymphoma (PTCL), excluding extranodal NK/T~     cell lymphoma (ENKTL). Patients will receive up to 8 courses of treatment.~   "
90045|NCT01878695|"~     NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a~     common over-the-counter supplement and also is available as an injectable pharmaceutical~     that protects the liver in cases of acetaminophen overdose. In the exercise physiology~     literature, both oral and injectable NAC have been shown to reduce fatigue and improve~     recovery from exertion which has interesting implications for exploring cancer-related~     fatigue.~      In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in~     the development and progression of breast cancer~   "
90046|NCT01878682|"~     VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source~     of gentle vibration. It has been specifically designed to overcome the limitations of tuning~     forks for testing the integrity of vibration sense in clinic and by the bedside. The product~     is a hand held device that is used to examine the feet of Diabetic patients who are~     susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive~     and can be over a period of time, often not being completely resolved, and can lead to~     amputation. The product will increase awareness of foot care and achieve a reduction in~     incidence of foot ulcers.~      The study aims to evaluate the accuracy of the VibraTip device compared to the Gold~     Standard, the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of~     the VibraTip® device, as measured by different community medical practitioners.~   "
90047|NCT01878669|"~     The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural~     myocardial infarction and major cardiac and cerebral events in patients undergoing~     percutaneous coronary intervention and who have moderate to high risk for contrast induced~     nephropathy.~   "
90048|NCT01878656|"~     Emergence agitation is a major concern in patients undergoing orthognathic surgery. The~     patients may experience the sense of suffocation during emergence due to nasotracheal~     intubation and orofacial edema. Postoperative pain is also associated with emergence~     agitation. Although there is a lot of studies about emergence agitation in children, there~     is a few in adults, furthermore, no data about comparison of emergence agitation between~     sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to~     compare the incidence and severity of emergence agitation between sevoflurane and desflurane~     anesthesia in adults after orthognathic surgery.~   "
90049|NCT01878643|"~     The purpose of this study was :~        -  to determine the effect of inhaled antibiotics on airway bacteria in ventilated~          patients~        -  to determine the effect of inhaled antibiotics on respiratory infection~   "
90050|NCT01878630|"~     Superiority of additional Remote Patient Management (RPM) in patients with chronic heart~     failure (CHF) in comparison to usual care in terms of, e.g.:~        -  days lost due to unplanned cardiovascular hospitalization or death~        -  all-cause mortality~        -  cardiovascular mortality~        -  quality of life~   "
90087|NCT01878136|"~     This study will evaluate the hypothesis that the administration of intraventricular tPA~     reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent~     hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.~   "
90088|NCT01878123|"~     This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time~     in human study of AMP-110 in adult subjects with rheumatoid arthritis.~   "
90090|NCT01878097|"~     The purpose of this study is to evaluate the statewide application of Green Dot among high~     schools students. We hypothesize that students in high schools with Green Dot will over time~     report lower rates of sexual violence (SV) compared with students in comparable high schools~     randomized not to have Green Dot. This reduction in sexual violence will be mediated through~     a reduction in social norms supporting sexual violence (measured with violence acceptance~     scales) and an increase in bystander behaviors.~   "
90051|NCT01878617|"~     Historically, medulloblastoma treatment has been determined by the amount of leftover~     disease present after surgery, also known as clinical risk (standard vs. high risk). Recent~     studies have shown that medulloblastoma is made up of distinct molecular subgroups which~     respond differently to treatment. This suggests that clinical risk alone is not adequate to~     identify actual risk of recurrence. In order to address this, we will stratify~     medulloblastoma treatment in this phase II clinical trial based on both clinical risk (low,~     standard, intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH).~     This stratified clinical and molecular treatment approach will be used to evaluate the~     following:~        -  To find out if participants with low-risk WNT tumors can be treated with a lower dose~          of radiation to the brain and spine, and a lower dose of the chemotherapy drug~          cyclophosphamide while still achieving the same survival rate as past St. Jude studies~          with fewer side effects.~        -  To find out if adding targeted chemotherapy after standard chemotherapy will benefit~          participants with SHH positive tumors.~        -  To find out if adding new chemotherapy agents to the standard chemotherapy will improve~          the outcome for intermediate and high risk Non-WNT Non-SHH tumors.~        -  To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced~          dose cyclophosphamide and compare this to participants from the past St. Jude study.~      All participants on this study will have surgery to remove as much of the primary tumor as~     safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and~     type of chemotherapy received will be determined by the participant's treatment stratum.~     Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and~     clinical risk.~      The participant will be assigned to one of three medulloblastoma subgroups determined by~     analysis of the tumor tissue for tumor biomarkers:~        -  WNT (Strata W): positive for WNT biomarkers~        -  SHH (Strata S): positive for SHH biomarkers~        -  Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHH~          biomarkers or results are indeterminable~      Participants will then be assigned to a clinical risk group (low, standard, intermediate, or~     high) based on assessment of:~        -  How much tumor is left after surgery~        -  If the cancer has spread to other sites outside the brain [i.e., to the spinal cord or~          within the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)]~        -  The appearance of the tumor cells under the microscope~        -  Whether or not there are chromosomal abnormalities in the tumor, and if present, what~          type (also called cytogenetics analysis)~   "
90052|NCT01878604|"~     Identify new or novel genes which may impact on cholesterol level, and establish the~     relationship between those gene mutations with atherosclerosis, as well as responses to~     lipid-lowering drugs.~   "
90053|NCT01878591|"~     To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in~     nulliparous women at term with singleton pregnancies and prolonged second stage of labor.~      To compare different ultrasound assessments Compare digital assessments and ultrasound~     findings. Investigate if movement of the fetal head during active pushing is a predictive~     factor~      Null hypotheses:~        -  Ultrasound measurements cannot predict outcomes of operative vaginal delivery.~        -  Ultrasound is not better than digital examination in predicting delivery outcome.~        -  Movement of fetal head with active pushing is not a predictive factor.~   "
90054|NCT01878578|"~     The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA~     2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the~     tolerability and safety of ESL administered concomitantly with phenytoin in patients.~   "
90055|NCT01878565|"~     The host immunity has been generally recognized as the main factors to determine the outcome~     of chronic hepatitis B virus (HBV) infection; however, previous studies have shown that~     HBV-specific T cell and B cell function are exhausted in chronic hepatitis B (CHB) patients.~     Recently, It is suggested that hepatitis B surface antigen (HBsAg) may play a key role in~     the immune tolerance or immune exhaustion. Anti-HBV immune responses are partially recovered~     when patients achieved hepatitis B e antigen (HBeAg) seroconversion during antiviral~     therapy, and can be nearly recovered during HBsAg seroconversion. However, it is still~     difficult to achieve the ideal terminal, HBsAg seroconversion. For this reason,~     immunotherapy would be helpful to enhance the anti-HBV immunity and acquire higher HBsAg~     seroconversion. Here, the investigators propose a hypothesis that hepatitis B immune globin~     (HBIG)+granulocyte-macrophage colony-stimulating factor (GM-CSF)+HBV vaccine can enhance~     anti-HBV immune responses and improve HBsAg seroconversion in CHB patients who has achieved~     HBeAg seroconversion using nucleoside analogues treatment.~   "
90056|NCT01878552|"~     The investigator would assess if there is an incremental energy load during mechanical~     ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.~   "
90057|NCT01878539|"~     An intervention program targeting patients and caregivers based on education about their~     condition and training in the use of portable coagulomenter to self monitor and training on~     the treatment adjustment to self manage, can be effective to enable patients in OACs to self~     manage as well as to identify determinant factors associated with the success and failure of~     the program.~   "
90058|NCT01878526|"~     The investigators purposes are to define the prevalence of omeprazole resistance~     gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy~     of omeprazole in combination with algycon versus omeprazole in combination with domperidone~     on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the~     efficacy of omeprazole in combination with algycon versus omeprazole in combination with~     domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.~   "
90059|NCT01878513|"~     The aim of the study is to examine whether determining treatment strategies based upon~     Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome~     in patients with psychosis.~      The investigators predict that prospectively testing CYP2D6 genotype and using this~     information to treat psychotic patients with risperidone will improve clinical outcomes.~     Specifically, CYP2D6 poor metabolizers who are treated with low dose and slow titration of~     risperidone will do better than those who are treated with usual dose and titration approach~     in terms of rates of side effects and clinical improvement.~   "
90060|NCT01878500|"~     The aim of this study is to investigate the use of intraoperative stereotactic imaging of~     the pelvic floor musculature during closure of bladder exstrophy.~   "
90061|NCT01878487|"~     To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with~     ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration~     catheter in 40 patients during primary PCI.~   "
90062|NCT01878474|"~     The purpose of this study is to assess the safety and tolerability of single doses of~     TA-8995 in healthy Caucasian and Japanese volunteers.~   "
90063|NCT01878461|"~     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque~     psoriasis~   "
90064|NCT01878448|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd.~      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2~     and VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore~     ALTN for the effectiveness of advanced soft tissue sarcoma and security.~   "
90065|NCT01878435|"~     The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile~     phone short message system (SMS) reminders, either with or without mobile-phone based travel~     subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in~     rural western Kenya.~   "
90066|NCT01878422|"~     Study Design: This is a pragmatic study on the management strategy for patients with~     metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous~     adjuvant therapy received. The aim of this study is to define the role of new target~     molecules in combination with CT in first- and second line treatment.~      First line study: Eligible patients were randomized to either treatment:~      Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks~        -  BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well~          tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well~          tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus~        -  FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min~      Day 1,2:~      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus~     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85~     mg/m2 IV infusion of 2hours~      Day 1,2:~      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus~     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle~     to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab~     If FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both~     arms, CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If~     unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT~     and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until~     progression or intolerable toxicity occurred.~      Second line - it is divided in two different studies (2A and 2B):~      Study 2A: Patients from arm A and Kras Wild Type were randomized to:~        -  Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in~          arm B)~        -  Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described~          in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs~          before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1~          hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm~          C.~      Study 2B: Patients from arm B and Kras Wild Type were randomized to:~        -  Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as~          defined in arm B) plus BEVACIZUMAB~        -  Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as~          defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks,~          whilst cetuximab will be administered weekly.~        -  BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if~          well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent~          cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on~          the 2nd day~        -  CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st~          cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion~          If cetuximab will be stopped for any of the reasons specified in this protocol,~          bevacizumab will be administered as defined in arm A of the 1st line study Patients~          from arm B and Kras Mutant were treated according to arm E. Objectives of study The~          primary objective of the 1st line study is to determine whether the addition of~          bevacizumab to a poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves~          efficacy in terms of progression-free survival (PFS). The secondary objectives of the~          1st line study are to determine the Overall Response Rate (ORR) and the safety profile~          of the treatments administered.~      The primary objective of the 2nd line studies is to determine, separately for each study,~     whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT~     schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the~     2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile~     of the treatments administered.~   "
90067|NCT01878409|"~     The aim of this study is to evaluate the different aspects of sexual function among adults~     with Parkinson Disease to develop a treatment and address sexual problems as a routine part~     of diagnostic workup and therapeutic planning.~   "
90068|NCT01878396|"~     The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in~     Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated~     BRAF.~   "
90069|NCT01878383|"~     PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system~     (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and~     nonpregnant women) and with HSV culture (nonpregnant women). The GeneXpert system performs~     all sample-processing steps and real-time PCR in a single integrated cartridge. The standard~     cartridge is an inexpensive disposable plastic cartridge with filtration and ultrasonic~     lysis capabilities. It consists chiefly of several combined molded plastic components: a~     cartridge body containing eleven fluid reservoirs or chambers along with an attached PCR~     tube, a specialized valve body with an ultrasonic interface containing a sub-micron filter~     and glass lysis beads, and a rotary valve with an axial syringe barrel. The operation of the~     cartridge is simple. The rotary valve contains an inlet and an outlet port. Fluid such as a~     sample buffer can be drawn up into a syringe drive through the inlet port of the rotary~     valve and then dispensed into any other chamber within the cartridge by rotating the valve~     and expelling the fluid through the outlet port. The fluid can either be passed through a~     filter contained within the valve assembly or it can be passed directly into the next~     chamber without filtration, depending on the path that is chosen. The cartridge fluidics and~     subsequent real-time PCR all are performed within the GeneXpert instrument. The GeneXpert~     contains multiple modules (ICORE units) that can be independently programmed to drive the~     syringe/rotary valve, and to perform four-color real-time PCR. Each cartridge fits inside~     one module, and all processing, PCR, and analysis steps are performed automatically. Each~     ICORE module can be run and analyzed independently, so batching of samples is unnecessary.~   "
90070|NCT01878370|"~     In a previous study, the investigators delivered graphs to family physicians that outlined~     the proportion of patients with a history of diabetes or heart disease achieving~     evidence-based quality targets derived from guideline recommendations. A qualitative~     evaluation found that participating family physicians did not act upon the feedback for two~     main reasons. First, they felt that targets recommended in guidelines often did not apply~     for particular patients. Second, they complained that had difficulty using the feedback~     reports that only provided aggregate level data for clinical action. In this~     cluster-randomized trial, the investigators test two approaches to conducting audit and~     feedback that aims to address these issues. The investigators hypothesize that feedback~     identifying a small number of patients at high-risk for cardiovascular events requiring~     action will more effectively lead to changes in clinical behavior than feedback identifying~     all patients not reaching optimal care targets.~   "
90071|NCT01878357|"~     Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be~     applied as strategies for eliminating malaria when focusing on transmission stages. Many~     studies either with MDA or MST has been done in low transmission areas demonstrated the~     impact of those activities to reduce malaria transmission. However, in high transmission~     such study is still very limited which is becoming the reason behind this study.~      A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine~     (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur~     province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention~     arm of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass~     screening and treatment with interval of 3 months and (3) control arm without mass screening~     and treatment. The intervention arm with 6 weeks interval represents a new proposed method~     to detection malaria infections, while the intervention arm with 3 month interval represents~     the Ministry of Health current policy of active case detection in Indonesia, and the third~     arm will serve as the control for Ministry of Health's policy.~      The study will be conducted in 6 months period and evaluate various parameters including~     malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and~     3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All~     positive subject in all arms will receive supervised treatment. Secondary objectives are the~     proportion of gametocytemia in the community, the proportion of malaria antibody of various~     age groups, population genetic of local parasite, submicroscopic incidence based polymerase~     chain reaction and the proportion of infective mosquitoes. Data analysis will be performed~     according to the method for cluster randomized trial evaluation.~   "
90072|NCT01878344|"~     The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and~     cerebral events in patients undergoing primary percutaneous coronary intervention who have~     moderate to high risk for contrast induced nephropathy.~      In a sub-group of patients coronary flow reserve will be evaluated.~   "
90073|NCT01878331|"~     Patients with an edentulous mandible restored with implants who have participated in the~     core study CR 04/07 will be recruited for this extension study. No further interventions~     will be made for this extension study other than a clinical follow-up examination and~     questionnaires. Patients will not receive an investigational treatment in this study.~     Patients will be followed at 5 to 10 years from the date of the original implant loading~   "
90075|NCT01878305|"~     Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging.~     Clinical scoring systems produce insufficient information with deeply sedated patients, and~     disturbances of normal hemostasis limit the use of invasive intra-cranial pressure~     measurements. EEG based monitoring algorithms have been introduced into the operation~     theater and general anaesthesia, but these algorithms cannot be used in the intensive care~     setting without modifications. EEG is also susceptible to electrical disturbances, such as~     those created by patient movement.~      The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of~     Helsinki. The total number of patients in this study is 20, and it is a part of a larger~     neuromonitoring study with a total of 110 patients. The patients are divided into four~     subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients~     admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative~     total heart arrest, 3. patients admitted to the ICU because of status epilepticus and~     finally 4. patients in critical condition, admitted to the ICU after any surgery. This study~     concentrates on the first group of patients with acute liver failure.~      Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will~     added to routine monitoring. To evaluate the neurological status the following tests are~     performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of~     EEG is measured along with the raw EEG signal.~      The recruiting of study patients was begun in December 2005 and the final study patients~     were recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring~     devices and pays the salary of the research nurses who collect the study data. Clinical~     investigators will not receive funding from any commercial company. All patients (or their~     next of kin) included have given their written informed consent for inclusion in the study.~      The aim of this study is to find new factors and new non-invasive techniques, which~     correlate with the neurological state and outcome of patients suffering critical illness.~   "
90076|NCT01878292|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive~     disorder.~   "
90077|NCT01878279|"~     In the proposed study, the investigators will carry out novel research to evaluate both~     symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy~     number in children with and without HIV.~      Study Objectives:~        1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected~          children~           Secondary Objectives:~        2. To determine the acceptability of performing daily oral swabs in children age 3-12~   "
90078|NCT01878266|"~     This Trial offers a reduction in patient burden, which is especially preferable in children~     with a poor compliance and poor performance status. This prospective randomized trial was~     extension to the previous controlled prospective study performed in Children's Cancer~     Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this~     work is to demonstrate noninferiority of the hypofractionated regimens relative to the~     conventional regimen in a controlled randomized clinical study.~   "
90079|NCT01878240|"~     Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age~     groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death.~     Federal funding through Medicare has been allocated for early detection using abdominal~     ultrasound screening programs. Despite these more aggressive screening programs and~     concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued~     to increase.~      Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006.~     Multiple studies reflecting decreased perioperative morbidity and mortality over open repair~     make this an attractive option for patients. EVAR requires more intensive follow-up than~     standard open surgical repair, however. Secondary interventions are more common to maintain~     seal of the endograft within the aorta and subsequent exclusion of the aneurysmal~     component.~      The term endoleak is specific to EVAR, and describes the primary means by which endografts~     fail. Type I endoleaks occur because of inadequate graft seal proximally or distally,~     resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when~     branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to~     collateral flow. Type III endoleaks occur when flow persists between segments of a modular~     graft. Type IV endoleaks occur when flow persists through endograft material (graft~     porosity). Type V endoleaks have also been called endotension, and occur when~     pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and~     Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks~     can also lead to aneurysm rupture and premature death.~      The most common method of EVAR follow-up is computed tomographic angiography (CTA). These~     studies allow accurate measurement of aneurysm sac diameters and volumes. They also are~     highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain~     persistent and are present in the setting of aneurysm sac enlargement. Type I and III~     endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with~     current endograft technology.~   "
90080|NCT01878227|"~     The purpose of this study is to compare the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in~     Chinese patients with moderate dyslipidemia.~   "
90081|NCT01878214|"~     The purpose of this study is to test an innovative and sustainable intervention to increase~     participation in a union-sponsored smoking cessation program among carpenters and floor~     layers. The investigators will conduct a randomized controlled trial comparing targeted~     messaging versus standard messaging. All subjects will receive information about the free,~     union-sponsored smoking cessation program. Subjects randomized to the intervention group~     will receive additional targeted materials to encourage enrollment in the union's smoking~     cessation program. The intervention will include monthly mailed and text messages. The~     investigators hypothesize that subjects who receive targeted messages will be more likely to~     enroll in the union-sponsored smoking cessation program, be more likely to show change in~     readiness to quit smoking, and be more likely to quit smoking compared to subjects who~     receive only standard messaging.~   "
90082|NCT01878201|"~     The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg~     during 24 hours in Patients with Mild to Moderate Essential Hypertension~   "
90083|NCT01878188|"~     -  Safety and tolerability of three regimens of intravesically administered BC-819/PEI and~          BCG (number of participants with AEs, discontinuations due to AEs)~        -  Recurrence after treatment with BC-819/PEI and BCG~        -  Approximately 18 patients with superficial transitional cell carcinoma TCC) of the~          bladder~        -  After initial evaluation and qualification, patients will be randomized to one of two~          treatment groups, either alternating or sequential~   "
90084|NCT01878175|"~     Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often~     used to treat hip osteoarthritis, which is more common among Veterans than the general~     population. Some patients continue to experience functional limitations after THA, and~     studies have shown that these patients still tend to put greater loads on the opposite leg,~     which can increase the risk of developing osteoarthritis in that leg. One likely reason for~     these post-surgical limitations is that rehabilitation is very minimal following this~     procedure. This project will involve development and preliminary testing of a functional~     movement retraining program, designed to help Veterans improve their function and~     biomechanics after THA. The project will also develop processes for delivering this program~     in Veterans' homes, to increase accessibility.~   "
90125|NCT01877642|"~     This study will compare the safety and effects over time for giving both ADASUVE and~     lorazepam (intramuscular) compared to that of each agent given alone.~   "
90091|NCT01878084|"~     The purpose of the present research is to evaluate the effect of bioactive glass in bone~     regeneration immediately following extraction of mandibular and maxillary premolars.The~     hypothesis of the study assumes that this treatment would promote the healing of the~     extraction socket while preserving both the height and width of the bone. Furthermore, it~     would allow more effective tooth movement during orthodontic treatment.~   "
90092|NCT01878071|"~     In recent years, greater emphasis has been placed on the link between oral and systemic~     health. Obesity, a growing medical problem worldwide, has been associated with multiple~     chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With~     respect to the effect of obesity on periodontal health, it has been shown that obese~     subjects exhibit higher inflammation around natural teeth and are at increased risk of tooth~     loss than individuals with normal weight. Peri-implantitis, an inflammatory condition of~     bacterial origin that occurs around oral implants and resembles periodontal disease, has~     become a serious concern for the dental profession given its increasing prevalence and~     challenging treatment. There is also strong evidence that individuals with a history of~     periodontitis are also at risk for peri-implantitis. However, knowledge about the~     pathogenesis and treatment of peri-implantitis is scarce. Hence, it is extremely important~     to understand the implications of excessive body fat on peri-implant health. Based on the~     current understanding on the effect of obesity on systemic and local inflammation around~     natural teeth, the investigators hypothesize that obesity will have a significant impact on~     peri-implant health by inducing an increased inflammatory response as measured by clinical~     as well as molecular markers of inflammation.~   "
90093|NCT01878058|"~     This study will look at the feasibility of using a type of Magnetic Resonance Imaging called~     Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds.~     Researchers hope that using SWI will eliminate the need to use CT imaging to detect your~     implanted radioactive seeds.~      This study will also see if the MRI seed detection is as effective as current standard~     practice of seed detection (routine MRI and CT imaging). This technique would be beneficial~     for brachytherapy without the need to fuse the MRI and CT images, as is done currently.~   "
90094|NCT01878045|"~     Background:~      - An ongoing study is looking at American Indians who have kidney problems caused by type 2~     diabetes. Kidney disease due to type 2 diabetes is a major problem in American Indians. We~     previously found that early treatment of kidney disease with losartan was probably~     beneficial for reducing progression of the disease. Researchers now want to see if these~     benefits continue to be seen several years after the end of the treatment study.~      Objectives:~      - To study long-term benefit of losartan treatment for diabetic kidney disease in American~     Indians with type 2 diabetes.~      Eligibility:~      - Participants in the American Indian diabetic kidney disease study (OH95-DK-N037).~      Design:~        -  Participants will have a physical exam and medical history before starting the study.~          Blood and urine samples will be collected.~        -  Participants will have a set of tests as part of this study. Those who have severe~          kidney problems, such as kidney failure, will only have a basic kidney exam with scans.~          The remaining participants will have a full urine collection and analysis. They will~          also provide a kidney biopsy.~        -  Treatment will not be provided as part of this study.~   "
90095|NCT01878032|"~     Background:~      - The purpose of this study is to find out whether color vision measured with the Cambridge~     Color Test is a good way to examine the severity of inherited retinal diseases (IRDs). IRDs~     are a major cause of vision loss worldwide, but very little is known about how the diseases~     affect color vision over time. This study will tell us if color vision may be used to track~     changes in inherited retinal diseases over time.~      Objectives:~      - To improve understanding of color vision as a way to measure changes in inherited retinal~     diseases.~      Eligibility:~        -  People 5 years of age or older who have an IRD.~        -  Healthy volunteers at least 5 years of age.~      Design:~        -  Participants will make at least one visit to the National Eye Institute clinic. If they~          sign up for more tests, they may have up to three visits to the NEI clinic.~        -  Participants will be asked questions about their medical and eye history.~        -  Participants will be given an eye exam, including eye drops to dilate their pupils.~          They will take the Cambridge Color Test, which includes looking at a monitor and~          pressing a button, and arranging colored circles. Several other tests may be offered,~          but participants can decline to take them.~        -  Treatment will not be provided as part of this study.~   "
90096|NCT01878019|"~     Background:~      - Researchers want to look at how the brain responds to painful stimulations. They also want~     to see if these responses are different in people with and without chronic pain. To test the~     brain s response, they will use a chemical called naloxone. Naloxone is used to treat~     overdoses of painkilling drugs like morphine. It may be able to block the effect of a~     pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg~     and look at the results of sensitivity tests with either naloxone or a placebo. This study~     will compare the results from people with chronic pain (like fibromyalgia) to those of~     people without chronic pain.~      Objectives:~      - To look at the brain s response to pain in people with and without chronic pain.~      Eligibility:~        -  Individuals at least 18 years of age who have fibromyalgia.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study will involve a screening visit and two testing visits. The testing visits~          will be about a week apart.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. After the screening participants will be administered~          several questionnaires about their personality, and their thoughts and feelings.~        -  At the first visit, participants will try out the magnetic resonance imaging (MRI) scan~          before using it at the next visit. They will then have the painkilling cream applied on~          one part of their lower leg and a normal moisturizing cream on the other part of their~          lower leg. They will have heat pulses on these skin areas and rate the pain.~        -  At the second visit, participants will have tests in the MRI scanner. The heat pulse~          tests will be repeated after an infusion of either naloxone or a placebo....~   "
90097|NCT01878006|"~     Background:~      - Small differences in genes may alter responses to drugs. One gene that has different forms~     is the mu opioid receptor gene. People with one form of this gene are more sensitive to~     alcohol. People with a different form are sometimes more sensitive to pain. Morphine and~     other prescription pain pills produce pain relief by acting at the mu opioid receptor.~     Researchers want to see how well a drug called remifentanil can help determine sensitivity~     to pain. Remifentanil is a strong but short-acting pain medication that is sometimes used~     for anesthesia during surgery. The study will test how much the drug causes the pupils to~     constrict.~      Objectives:~      - To see if remifentanil can help determine pain sensitivity.~      Eligibility:~      - Individuals between 21 and 55 years of age who are taking pain pills that were prescribed~     to treat pain from a medical or dental procedure.~      Design:~        -  This study has a screening phase and a study phase. The screening phase involves one or~          two visits of 5 to 6 hours. The study phase is one outpatient visit that will take~          about 3 hours.~        -  Participants will be screened with a medical and psychiatric history and physical exam.~          They will be asked about drinking and drug-taking history, and any family history of~          alcoholism or drug abuse. Blood, urine, and breath samples will be collected.~        -  During the study session, participants will test their sensitivity by placing one hand~          in cold water. Pupil diameter will be measured before and after the sensitivity test.~        -  After a blood sample is taken, participants will receive the remifentanil. The~          sensitivity test will be repeated. Final blood samples will be collected. A brief~          physical exam will also be performed.~        -  Participants will stay in the clinic until the effects of the drug have worn off.~        -  About 1 week after the study session, participants will have a follow-up phone call.~   "
90098|NCT01877993|"~     Autonomic nerve function is involved in both blood pressure (BP) regulation and the~     pathogenesis of coronary artery spasm (CAS), but few studies have been published about the~     relationship between CAS and BP, with the exception of studies that explore hypertension as~     a risk factor for CAS. The purpose of this study was to investigate the incidence of CAS and~     atrioventricular (AV) block in association with BP level. The investigators will register~     consecutive patients who underwent coronary angiography with an acetylcholine (Ach)-induced~     provocation test from November 2004 to May 2012. The investigators exclude from the patients~     who were taking antihypertensive drugs or who had a documented history of cardiovascular~     disease in order to avoid the confounding effects of cardiovascular medications on coronary~     vasomotion. CAS is defined as >70% luminal narrowing on Ach provocation and /or concurrent~     chest pain. The study population will be divided into quartiles of rising systolic BP and~     diastolic BP. The incidence of Ach-induced CAS according to each systolic BP/diastolic BP~     quartile will be evaluated.~   "
90099|NCT01877980|"~     The aim of the present study was to evaluate the ultrasonographic airway measurement in~     pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with~     the minimal transverse airway diameter (MTAD) with tube size predicted by different~     age-related formulas and diameter of little finger.~      Previous studies already showed that a prediction of pediatric ETT is possible with the~     ultrasonographic measurement of the MTAD. In this study measurements are performed at three~     predefined anatomic structures of the airway with each of These at two airway pressures.~      The investigators hypothesize that one of the specific measurements predicts the fitting ETT~     size better than age-related formulas or diameter of little finger.~   "
90100|NCT01877967|"~     This research aims to determine whether a 12 week daily dose of VSL#3 has any measurable~     effects on memory, attention, executive function or self-reported mood and anxiety in~     healthy older adults.~   "
90101|NCT01877954|"~     The primary aim of this study was to compare the absolute and relative effectiveness of~     asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS)~     maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI)~     compared with fluticasone propionate (FP) pMDI.~   "
90102|NCT01877941|"~     The specific aim of this study is to assess whether a device approved by the FDA to measure~     pulse oximetry can accurately estimate cardiac output.~   "
90103|NCT01877928|"~     The purpose of this study is to assess the efficacy of the Boussignac positive airway~     pressure system (a mask) applied immediately following post-operative extubation in~     improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be~     done before surgery and then at 1, 2 and 24 hours following extubation and will be compared~     to standard care for perioperative airway support. The study aims to give a broader and more~     inclusive picture (than the current literature) in terms of whether the Boussignac CPAP~     system should be considered for utilization by anesthesiologists caring for surgical~     patients with OSA.~   "
90104|NCT01877915|"~     The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared~     with placebo (inactive medication), in reducing the risk of death, myocardial infarction or~     stroke in participants with heart failure and significant coronary artery disease following~     an episode of decompensated heart failure.~   "
90105|NCT01877902|"~     STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN~     PUBLIC HEALTH SYSTEM~   "
90106|NCT01877889|"~     The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the~     body) of canagliflozin with the pharmacodynamics of dapagliflozin.~   "
90107|NCT01877876|"~     Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest~     version is RevK.~   "
90108|NCT01877863|"~     The purpose of this study is to explore the impact of an intradialytic exercise program on~     functional capacity, aerobic capacity, strength, quality of life, depression,~     hospitalizations and intradialytic episodes of hypotension. The investigators would also~     like to look at the impact of exercise training over twelve weeks on hemoglobin levels as~     well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above~     mentioned outcomes will positively improve over the twelve week intervention.~   "
90109|NCT01877850|"~     The purpose of this study is to evaluate the difference of the duration of weaning process~     from the ventilator between protocol-driven weaned patients and clinical judgment driven~     weaned patients.~   "
90110|NCT01877837|"~     This protocol will be investigating the use of stem cell transplantation, in related donors,~     to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point~     mutation that results in the substitution of valine for glutamic acid at the sixth position~     in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many~     conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to~     vaso-occlusion, which causes irreversible damage in almost all systems in the body,~     including the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.~   "
90111|NCT01877824|"~     All Danish trainees in surgery in a two-year period asked for participation when enrolled in~     the formal five-year training program for specialty in surgery. The participants are~     randomized for either educational intervention or control (without intervention). The~     intervention group receive a skills-lab course in hernia repair followed by an opportunity~     to perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance~     will be video recorded three times during the intervention and as follow-up at end of the~     first year of training. After termination of the hernia training program a similar program~     for laparoscopic cholecystectomies are made. Each participant receive both intervention. The~     control group are video recorded at start of their first year and at end. All videos are~     blindly assessed with a validated rating scale of operative performance. The purpose is to~     assess if a fast-track program improves technical skills and if a change is sustained.~     Furthermore we want to compare outcome in similar training programs in open and laparoscopic~     skills.~   "
90112|NCT01877811|"~     This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a~     dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced~     solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for~     administration. Phase 1b is a dose expansion in approximately 90 patients with advanced~     solid tumors with specific histologies and/or molecular alterations of interest. Patients in~     Phase 1b will be treated at the RP2D determined in Phase 1.~   "
90113|NCT01877798|"~     Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock~     therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio~     (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The~     purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen~     saturation (ScvO2) in the treatment of severe sepsis and septic shock.~   "
90114|NCT01877785|"~     This randomized, double-blind, placebo-controlled, single-ascending dose study will assess~     the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy~     volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching~     placebo.~   "
90115|NCT01877772|"~     This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff~     repair; bone trephination. Trephination is a procedure that involves making small~     perforations in the bone that the tendon is repaired to. The rotator cuff is repaired by~     sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is~     used in addition to the standard method of repairing the rotator cuff tendon. The control~     group will undergo the standard repair for rotator cuff tears.~      It is the investigators' hypothesis that healing rates in patients who undergo bone~     trephination will be higher compared with surgery without trephination in arthroscopic~     rotator cuff repair at 24 months post-operatively.~   "
90116|NCT01877759|"~     Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral~     infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the~     liver), or by blockage of biliary system such that the liver undergoes progressive scarring~     that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive~     hepatic fibrosis characterized by distortion of the hepatic architecture and formation of~     regenerative nodules. For this condition of disease the liver transplantation is one of the~     only effective therapies available ,but due to lack of donors, surgical complications,~     rejection, and high cost are it`s serious problems.~      Presently stem cells are used to be a one of the treatment for the same. So our approach is~     to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis~     .~   "
90117|NCT01877746|"~     The aim of this study is to compare the effect of combined immunosuppressive therapy given~     on the top standard medical therapy of chronic heart failure according to current guidelines~     with standard medical therapy of chronic heart failure alone in patients with infammatory~     cardiomyopathy (ICM).~      Suitable subjects are characterized by EMB established presence of myocardial inflammation /~     negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents~     and with varying duration of heart failure symptoms and left ventricular (LV) systolic~     dysfunction (phase A).~      Further, to compare the effect of two regimens of combined immunosuppressive therapy in~     these patients with ICM (phase B).~   "
90118|NCT01877733|"~     The purpose of this study is to investigate the effect of maximal strength training (MST)~     compared to standard rehabilitation in patients operated with total knee arthroplasty.~     Previous studies report reduced physical function and muscle strength despite successful~     surgery inserting an artificial implant.~      Furthermore, great loss of muscle strength has been found in these patients in the early~     postoperative phase.~      The study is a randomized controlled trial. The investigators hypothesize that MST will~     increase muscle strength and physical function more than standard rehabilitation.~   "
90119|NCT01877720|"~     Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator~     interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV~     (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a~     nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover~     trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and~     airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and~     timing, inspiratory trigger delays time of synchrony between diaphragm contraction and~     ventilator assistance, and the asynchrony index (AI).~   "
90120|NCT01877707|"~     To identify whether home monitoring of multiple physiological parameters and biomarkers in~     sputum could provide advanced warning of an infective exacerbation or treatment failure~     before changes in patient-reported symptoms.~   "
90121|NCT01877694|"~     The purpose of this study is to evaluate the microbiological and clinical efficacy of~     Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one~     year of age and older with bacterial conjunctivitis in at least one eye may be eligible.~     Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or~     Vehicle Ophthalmic Solution.~   "
90122|NCT01877681|"~     Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care~     in health centers. The chronic wound care by skilled personnel is key to healing and~     management of these injuries. An inter-clinical telematic program for PU in Primary Care~     (PC) can improve the effectiveness of interventions and cost savings.~      Objective: To evaluate the effectiveness and costs reduction after the implementation in PC~     setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses~     for the management of PU in patients in home care setting.~      Methodology: A prospective pilot clinical trial in which 46 primary care nurses in~     Osakidetza will be randomly assigned to two parallel groups: experimental group and control~     group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III.~     The intervention will consist of a telematic advice from the reference nurse regarding~     chronic wound management in relation to a specific PU. Patients will be monitored for 8~     weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the~     effectiveness of the intervention, multilevel models or linear mixed models to take into~     account the auto-correlation at the individual level and nurse, will be used~   "
90123|NCT01877668|"~     This is a 12 month study investigating the effectiveness and safety of tofactinib in~     treating the signs and symptoms, improving physical function and preserving bone structure~     in patients with active psoriatic arthritis and had inadequate response to a traditional,~     non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.~   "
90124|NCT01877655|"~     The purpose of the study is to evaluate the efficacy of ASP0113 compared with placebo as~     measured by a primary composite endpoint of overall mortality and CMV end organ disease~     (EOD) through 1 year post-transplant. Safety of ASP0113 in subjects undergoing allogeneic~     HCT will also be evaluated.~   "
90127|NCT01877616|"~     Little is known on the prevalence of sleep disorders and their role in the increased~     prevalence of cardiovascular diseases in the developing world. We To assess the prevalence~     of major sleep disorders in a rural South American population, and to determine whether~     these conditions are associated with a poor cardiovascular health or with the occurrence of~     stroke or ischemic heart disease. This is a three-phase, population-based, door-to-door~     survey in Atahualpa. During phase I, all residents aged ≥40 years will be screened with~     validated Spanish versions of five questionnaires to evaluate major sleep disorders. In~     phase II, neurologists will examine persons suspected of having a sleep disorder and a~     random sample of negative individuals to assess the prevalence of these conditions and to~     validate the accuracy of questionnaires. In phase III, patients with a confirmed sleep~     disorder will undergo nocturnal polysomnography for achieving a more specific diagnosis. The~     occurrence of sleep disorders will be correlated with the cardiovascular health of the~     population as well as with the presence of stroke and ischemic heart disease. This~     epidemiological study may prove cost-effective in improving sleep conditions of people~     living in rural areas of developing countries, and may be used as a model for the evaluation~     of sleep disorders and their cardiovascular correlates in these populations.~   "
90128|NCT01877603|"~     Irisin is a signaling protein that is released into the blood from skeletal muscle after~     proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin~     activity on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1~     expression and induction of brown adipocytes in white adipose tissue depots, a process known~     as white fat ''browning''. Irisin increases total energy expenditure in animal models, and~     irisin expression in mice fed a high fat diet resulted in a significant improvement in~     glucose tolerance and a reduction in fasting insulin levels. Collectively, these data~     suggest that decreased serum irisin levels may be associated with the development of insulin~     resistance and Type 2 diabetes. Indeed, some studies showed that irisin levels were~     decreased in newly diagnosed Type 2 diabetes.~      Endothelial dysfunction is an early physiological event in atherosclerosis. However, to~     date, no data are available on the relationship between circulating irisin and endothelial~     dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin~     level is associated with endothelial dysfunction.~   "
90129|NCT01877590|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2~     diabetes is understandably directed toward treating coronary artery conditions. However~     there are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even~     in the absence of hypertension. It is a strong predictor of cardiovascular events and~     all-cause mortality. Regression of LVH has been associated with an improved prognosis,~     independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality~     in type 2 diabetes with CAD might will be reduced if the investigators can find novel~     therapies to regress LVH.~      Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can~     improve endothelial function in diabetic conditions. Hence, the main aim of this study was~     to assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.~   "
90130|NCT01877577|"~     This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and~     quality of life in IBD patients deficient in vitamin D, and also help determine the optimal~     dose of vitamin D3 for them.~      Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve~     their quality of life and decrease IBD activity.~   "
90131|NCT01877564|"~     The purpose of this research is to determine the effects of Metformin, a well tolerated drug~     widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.~   "
90132|NCT01877551|"~     Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected~     people than the general population. Protease inhibitor booster antiretroviral therapy~     (PI-ART) which is used by ~50% of HIV infected people in the USA is an established risk~     factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt,~     improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these~     benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin~     action in people with HIV who are receiving PI-ART. Further, this project will clarify the~     molecular mechanisms responsible for these improvements potentially benefiting society,~     irrespective of HIV status.~   "
90133|NCT01877538|"~     AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system.~      MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 in our~     study. The participants will receive a careful medical examination, including a neurological~     examination, as part of the inclusion process. The subjects also have an MRI scan of the~     brain. PET/CT scans with [11C]donepezil are conducted. Six subjects will receive two PET/CT~     scans - once for the upper abdominal region and once for the head region two evaluate~     dynamic binding characteristics of the tracer in internal organ. Additionally, one single~     subject will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of~     this tracer.~      PERSPECTIVES: The study will potentially result in the development of a PET ligand for~     imaging the parasympathetic nervous system. This will have applications for research in~     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic~     nervous system is involved~   "
90134|NCT01877525|"~     Resect and discard (RD) is a new paradigm for management of diminutive colorectal polyps~     wherein histology is determined by real-time endoscopic imaging; polyps are then resected~     and discarded rather than sent for histopathological review. The aims of this study were to~     compare the surveillance recommendations between RD and the standard of care where polyps~     are sent for histopathological review in a mixed setting of academic and community~     gastroenterologists and to evaluate the diagnostic performance of an RD program for~     management of diminutive polyps.~   "
90160|NCT01877174|"~     This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be~     enrolled. The purpose of the study is to evaluate any debris that may be captured in the~     inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in~     a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses~     reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE~     marked and is used in routine practice for the purpose of this study.~   "
90135|NCT01877512|"~     Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both~     associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the~     normal range, have also been found with cardiovascular risk factors and disease in the~     general population, it would be interesting to investigate if this association can also be~     found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could~     be of interest for endocrinologists prescribing GH in clinical practice because strict~     dosing may become even more important. Next to that, scientific evidence for clinical~     practice is wanted.~      Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid~     profile; secondary objectives: remainder) we investigate the effect on glucose metabolism,~     physical performance, and neuropsychological functioning of different levels of IGF-I in GH~     treated GHD men and women.~      Study design: Open-label randomized trial.~      Study population: At least 32 subjects, both childhood as adult onset GHD men and women,~     receiving GH treatment for at least one year, with an age between 20 and 65 years.~      Intervention: At entry subjects are already receiving GH treatment according to general~     clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score~     (SDS) (normal dose). The group of men and group of women will be randomized to receive~     either a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS)~     (low dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high~     dose) for at least 24 weeks.~   "
90136|NCT01877499|"~     Two recent randomized controlled trials (RCT) on online hemodiafiltration (HDF) did not show~     a treatment effect on patient survival when compared with low‐ or high‐flux hemodialysis.~     Interestingly, post‐hoc (on treatment) analyses from both trials unequivocally showed~     reduced mortality in the patient group achieving the highest convection volumes. Moreover, a~     third trial recently found a significant 30% decrease in mortality when HDF was applied with~     a mean convection volume of 23.7 L per session, which was somewhat higher than the average~     volumes reached in the aforementioned trials. Altogether, these findings support the concept~     of a dose-response effect, in which a minimally delivered convection volume is required in~     order to show a survival benefit.~      Hence, the question arises whether high convection volumes are achievable in the majority of~     patients. The aim of this study is thus to test the following hypothesis: high‐volume (>22~     liters per treatment) post-dilution on‐line hemodiafiltration (HDF) is achievable in the~     majority (>75%) of patients treated with chronic intermittent hemodialysis. This will be~     done through the use of a dedicated standardized protocol, in which the three most important~     determinants of convection volume will be successively optimized: treatment time, blood flow~     rate and filtration fraction.~   "
90137|NCT01877486|"~     To determine the efficacy of cryoablation alone in patients with paroxysmal atrial~     fibrillation who have been pretreated with dofetilide and converted from persistent atrial~     fibrillation.~   "
90138|NCT01877473|"~     The hypothesis of this study is that by facilitating reverse atrial remodeling with~     maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a~     simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex~     atrial ablation for patients with persistent AF.~   "
90139|NCT01877460|"~     This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk~     supplemented with sodium alginates at incremental doses on inter-meal glucose levels,~     appetite scores and food intake in healthy adult men. The findings of this study will~     illustrate whether the addition of sodium alginate to chocolate milk will improve the~     glycemic properties of chocolate milk and will potentiate its satiating characteristics.~     This study will also elucidate whether sodium alginates, incorporated into chocolate milk,~     will influence glycemia, appetite sensations and food intake in a dose-dependent manner. It~     is hypothesized that there will be a synergy between milk and sodium alginate beyond either~     alone. When combined with milk components, sodium alginate is expected to improve glycemia~     and induce satiety more than does either milk alone or alginate alone.~   "
90140|NCT01877447|"~     Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application~     of a weak electrical current over the scalp through two electrodes - the anode, which~     facilitates neuronal depolarization, and the cathode, which leads to neuronal~     hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied~     daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically,~     tDCS displays depression improvement through anodal stimulation over the left dorsolateral~     prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive~     during the acute depressive episode. The present study is aimed at comparing two different~     tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with~     cathode placed over an extra cephalic area; (2) active cathode placed over the right~     dorsolateral prefrontal cortex with anode placed over an extra cephalic area.~   "
90141|NCT01877434|"~     Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder~     diseases with improved functional outcome. This study has evaluated patients operated with~     reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported~     outcome, clinical and radiological examination, complication and reoperations. The~     radiologic phenomenom and clinical impact of scapular notching (SN) and arm length~     difference has been evaluated.~   "
90142|NCT01877421|"~     This study is to assess the safety and tolerability of single doses and multiple doses in~     reducing plaque and gingivitis when delivered in a chewing gum formulation.~   "
90143|NCT01877408|"~     To identify a minimally-invasive surgical circumcision technique for men, which is easy to~     learn and perform, is safe, and is associated with high patient satisfaction and excellent~     cosmetic results.~   "
90159|NCT01877187|"~     The purpose of this study is to determine the whether Lipiodol can be used as an imaging~     biomarker, predicting tumor response to therapy in patients with primary and metastatic~     liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted~     standard of care procedure for unresectable liver lesions for several decades. Lipiodol is~     used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE~     procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via~     the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be~     evaluated every 1, 3 and 6 months by clinic visits, MRI/ CT scans and blood tests (to~     include assessment of liver function and tumor markers). After the 6th month, patients will~     be followed every 2-3 months for a period of up to 4 years.~   "
90144|NCT01877395|"~     The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies~     Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration~     of human rabies immunoglobulins (Imovax® Rabies).~      Primary Objectives:~        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of~          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5~          international units (IU)/mL at Day 14.~        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5~          IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI)~          of at least 97%.~      Secondary Objectives:~        -  To assess the clinical safety of each vaccine after each vaccine injection when~          administered in a simulated post-exposure schedule.~        -  To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day~          14.~   "
90145|NCT01877382|"~     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability,~     identify an maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and~     assess its pharmacokinetic (PK)/ pharmacodynamic (PD) properties in subjects with advanced~     solid tumors or lymphomas.~      Approximately 5 US sites are planned for Part 1 (Dose Escalation). Approximately 10 US sites~     are planned for Part 2 (Dose Expansion).~   "
90146|NCT01877356|"~     The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric~     Prilocaine with classical bilateral spinal anesthesia using plain Prilocaine according to~     block characteristics and quality of micturition, standardized to the subjects own~     functional bladder capacity. Our hypothesis is that unilateral spinal anesthesia will~     provide faster time to micturtition and discharge, lesser hypotension and lesser micturition~     problems.~   "
90147|NCT01877343|"~     This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt~     table and a stress test will be performed in a total of 4 different positions. Their blood~     pressure will be measured at each position. Also, a pulse oximeter will be placed on the~     forehead to measure pulse rate and strength. These results will be compared to cardiac~     functional classifications defined by New York Heart Association (NYHA) criteria for adults~     and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The~     primary aim of this initiative is to assess the discriminatory value of a cardiac functional~     health classification based upon the degree of dependency of cardiac function on changes in~     cardiac preload and afterload circulatory volume.~   "
90148|NCT01877330|"~     This is a prospective randomized clinical trial to determine where is the optimal location~     for local anesthetic injection for ultrasound guided interscalene nerve blocks. The~     investigators are investigating if local anesthetic deposited between the nerve roots is~     more effective than local anesthetic deposited in the interscalene groove.~   "
90149|NCT01877317|"~     The purpose of this clinical study is to validate the comparability of prescription formula~     fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting~     of hearing aids based on hearing loss screening (mild to moderate hearing losses) using~     in-situ audiometry, provided and executed through the mobile medical app.~   "
90150|NCT01877304|"~     To compare deposition between two modalities of nebulization~   "
90151|NCT01877291|"~     Background: Smoking is a key factor for development and progression of chronic obstructive~     pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease,~     there are few studies that report physiological or inflammatory changes in the upper airways~     in young asymptomatic smokers. The investigators investigated physiologic and inflammatory~     changes in the nasal and lower airways of young smokers and if these changes were related to~     smoking history.~      Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers)~     participated in this study. The investigators measured nasal mucociliary clearance (MCC),~     nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in~     nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.~   "
90152|NCT01877278|"~     The aim of the study is to evaluate the efficacy of a wearable device using pulse~     electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS)~     and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients~     affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion~     reduction, when present and to evaluate pain intensity changes corrected by pain threshold~     measured by pressure algometry.~   "
90153|NCT01877265|"~     This study looks at the amount of LY2605541 in the body after it is injected under the skin.~     The study has 3 periods, each lasting 10 days. Each participant will receive one injection~     in each period. At least 14 days will pass between each injection.~   "
90154|NCT01877252|"~     The principal research question is which treatment modality between open surgical,~     endovascular and conservative therapy is the most effective in terms of limb salvage,~     survival and reinterventions in patients with critical limb ischemia~   "
90155|NCT01877239|"~     This is a prospective non-interventional observational study to evaluate the treatment of~     moderately active RA patients in every day clinical practice in Austria. Patients will be~     observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI~     remission after 24 weeks.~   "
90156|NCT01877226|"~     The purpose of this study is to evaluate pharmacokinetics (explores what the body does to~     the drug), safety and tolerability of single and multiple-dose of tapentadol in healthy~     participants.~   "
90157|NCT01877213|"~     One third of the costs of medical care for people with diabetes are related to~     hospitalization. Difficult diabetic patient, i.e. those with very high HbA1c, patients >~     75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a~     high rate of readmission when discharged at home after an initial hospitalization related to~     diabetes or its complications. The objective of the study is to test if a coaching with a~     care coordinating team after hospital discharge would decrease diabetes-related~     rehospitalization rate compared with usual care.~   "
90158|NCT01877200|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     the current status of diabetes management, control, and complications in diabetic subjects~     with type 2 diabetes in Bangladesh.~   "
90161|NCT01877161|"~     Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.~   "
90163|NCT01877135|"~     Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions,~     and factors associated with this AC. A retrospective cohort study will be conducted~     (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of~     anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC~     will be calculated. Factors associated with AC will be estimated using a multivariate Cox~     regression model.~   "
90164|NCT01877122|"~     Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be~     used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of~     life)of two devices at 3 months follow-up.~   "
90165|NCT01877109|"~     The purpose of this study is to establish a model which can predict the treatment outcome~     and the risk of treatment-related morbidity in patients with lymphoma.~   "
90166|NCT01877096|"~     The purpose of this study is to begin to examine the efficacy of a motivational interviewing~     intervention to increase African Americans' screening colonoscopy rates. The results from~     this pilot study will allow us to estimate the magnitude of the intervention and mediation~     effect sizes.~   "
90167|NCT01877083|"~     This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with~     KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At~     least 20 subjects with KIF5B-RET will be treated and will receive lenvatinib at a starting~     dose of 24 mg orally, once per day. Additional subjects with other RET translocations will~     be treated with lenvatinib at a starting dose of 24 mg orally, once per day. The study will~     consist of 3 phases: The Pretreatment Phase, The Treatment Phase and the Extension Phase.~     The Pretreatment Phase will include screening procedures and eligibility assessments. The~     Pretreatment Phase consists of a Screen 1, Screen 2 and Baseline Period. The Treatment Phase~     will begin when the subject has met all eligibility criteria on Day 1 of the first Treatment~     Cycle. The Treatment Phase contains the Treatment and Follow-up Periods. The Extension Phase~     will begin for subjects who received treatment in the study (either in the Treatment Period~     or Follow-up Period) at the time of database cutoff.~   "
90168|NCT01877070|"~     The purpose of this study is to collect information on how patients and their partners/close~     allies make treatment decisions when they have been diagnosed with early stage prostate~     cancer.~   "
90169|NCT01877057|"~     The increasing prevalence of overweight and obesity among the population contributes to~     increased incidences of chronic metabolic diseases. Healthcare costs related to these~     diseases are rising; prevention or delay of onset of disorders associated with overweight is~     needed. Food ingestion exerts a transient suppressive effect on appetite and further food~     intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating~     than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of~     pea protein has been shown to reduce food intake and increase satiety hormone levels in~     humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim~     to investigate the effects of human gastric fluid on the degradability of five different~     protected pea protein products. Further, in an ex vivo experiment on freshly obtained human~     duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal~     satiety hormone release by the five different prototypes. The prototype that is less~     degraded by human gastric fluid and is most effective in intestinal satiety hormone release~     will be used in a future clinical trial.~   "
90170|NCT01877044|"~     The higher prevalence of overweight and obesity among the population contributes to~     increased incidences of chronic metabolic diseases. Obesity is considered a low-grade~     systemic inflammatory condition through 1) production of pro-inflammatory cytokines by~     adipose tissue and 2) alterations in intestinal microbiota composition and associated~     increase in intestinal permeability. Healthcare costs related to these diseases are rising;~     prevention or delay of onset of disorders associated with overweight is needed.~     Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the~     intestinal microbiota composition and have beneficial effects on gut epithelial barrier,~     especially on permeability and innate immune function.~      Objective: To assess the effects of NAXUS on intestinal barrier function, immune system~     performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance~     of the product in different doses will also be investigated.~   "
90171|NCT01877031|"~     We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle~     to look at the time taken to place a central line, or specifically the time taken to place a~     needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a~     central line.~   "
90172|NCT01877018|"~     The implementation of screening programs for colorectal cancer by screening for fecal occult~     blood has proven effective in reducing the incidence and mortality from this type of~     neoplasms. However, to ensure the efficiency of the programs require population~     participation rates of at least 50%. Experiences in our country show that the population~     participation is far from this recommended minimum number.~      Interventions to promote preventive activities in primary care are well received by the~     population; in the case of colorectal cancer, direct recommendation of primary care~     professionals to carry out the screening is one of the factors with greatest impact on~     increasing population participation in such programs. Care overload, circuit design for~     screening without the direct intervention of primary care professionals and the multiplicity~     of tasks that they must face, are elements that influence the low recommendation for~     screening in the target population who consults for any other reason.~      The introduction of specific reminders in electronic medical record (in widespread use in~     primary care), as a tool to facilitate and encourage direct referral by physicians and nurse~     practitioners to perform colorectal cancer screening will mean an increase of at least 10%~     in participation of the target population, increasing the efficiency of screening programs.~     The introduction of this new software tool will have good acceptance and increase compliance~     with recommendations from health professionals.~   "
90173|NCT01877005|"~     Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in~     patients with advanced Hodgkin's lymphoma for whom no curative option is available.~   "
90202|NCT01876628|"~     The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting~     antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin,~     results in less tissue damage and a more rapid resolution of both systemic and local~     features, in a cost-effective manner. This study is a randomised controlled trial comparing~     Clindamycin with placebo.~   "
90174|NCT01876992|"~     The investigators know that metformin works at the level of the cells in the body by acting~     on a protein called CREB binding protein or CBP. What the investigators do not know is how~     this process is affected when the dose of the metformin is increased or changed.~      Currently the same doses of metformin are often used in both children and adults, but it is~     possible that the dose of metformin should be based on age and weight. Understanding how CBP~     works could potentially help us to tailor metformin treatment individually for patients~     based on their age, weight and CBP response.~   "
90175|NCT01876979|"~     Determining the cost effectiveness of two methods of wiring the jaws together during surgery~     to repair mandible fractures. One technique is more expensive but faster in application,~     while the other is less expensive and takes more time to apply.~   "
90176|NCT01876966|"~     The purpose of this study is to investigate the pharmacokinetic interaction between~     etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine~     in healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic~     interaction' means that one medication can influence the absorption and elimination from the~     body of the other medication.~   "
90177|NCT01876953|"~     This phase I/II trial studies the side effects and best dose of dasatinib when given~     together with cytarabine and idarubicin hydrochloride and to see how well they work in~     treating patients with acute myeloid leukemia that is likely to come back or spread.~     Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin hydrochloride,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving dasatinib together with cytarabine and idarubicin~     hydrochloride may be a better treatment for acute myeloid leukemia.~   "
90178|NCT01876940|"~     The goal of this prospective randomized study is to compare the effect of operator~     experience on the ability to use fiberoptic-guided intubation in children less than two~     years old, with and without the use of an air-Q as a conduit. The question the investigators~     are trying to answer is: Does the operator experience make a significant difference in the~     time for successful fiberoptic guided tracheal intubation with and without the use of an~     air-Q intubating laryngeal airway?~   "
90179|NCT01876927|"~     Study design:~      Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up~     Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up~      Population:~      Male or female, 18-75 years of age, with a diagnosis of histologically confirmed,~     potentially resectable adenocarcinoma of the stomach.~      Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%,~     alpha=0.05 (two sides), beta=0.2)~      Treatment Plan:~      Treatment will be administered for 4 and 2 cycles before surgery in arm A and B,~     respectively, and in arm B for a further 2 cycles after surgery unless progression or~     unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go~     off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative~     cycle, patients will undergo surgery.~      After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.~      DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2~     daily for 2 weeks~      Cycles repeated every 3 weeks~      Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria~     (version 1.1).~      Duration of Study:~      Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years~   "
90180|NCT01876914|"~     Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when~     fluid and proteins collect in the macula (the yellow central area of the retina). The fluid~     can cause swelling which in turn can lead to worsening central vision. The purpose of this~     study is to see if the study device (Swept Source Optical Coherence Tomography or SS-OCT) is~     able to diagnose DME as well as an already approved imaging procedure called fluorescein~     angiography (FA). FA is standard of care and would be conducted regardless of study~     participation. The dye used in FA, which can cause allergic reactions in some patients and~     is not used in pregnant women, is not needed with the study device. Another purpose of the~     study is to avoid the risk of administering the FA dye if possible.~   "
90181|NCT01876901|"~     Hypothesis:~      In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one~     and a half times higher in men than in women. The average age of diagnosis is 65. Unlike~     colon cancer, technical management remains challenging with unresolved operating~     difficulties. Morbidity of surgical procedures remains high with a very large number of~     preventive or curative stoma derivations.~      Reference in surgical treatment is total excision of the rectum and its mesentery, followed~     by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate~     of fistula that results is reported in the literature between 15 and 25%.~      An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on~     retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of~     fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and~     mortality are reduced, and patient's quality of life greatly improved. Direct costs~     (consumables intraoperative, hospitalization, stoma complications) and indirect~     (pocket-fitting stoma) are greatly reduced.~      This study is a multicentre, two arms, phase 2 clinical trial.~   "
90182|NCT01876888|"~     The aims of this study were to perform cultural adaptation of the MedRisk Instrument for~     Measuring Patient Satisfaction With Physical Therapy Care (MRPS) instrument and provide~     information regarding the factor structure, group-level reliability, and~     criterion-referenced validity of the instrument in Turkish speaking patients.~   "
90183|NCT01876875|"~     Low-grade systemic inflammation associated with obesity may worsen the clinical course of~     psoriasis. Both a low-calorie diet and nutritional supplementation have been shown to have~     an impact on the clinical course of psoriasis, including an anti-inflammatory effect of n-3~     polyunsaturated fatty acids (PUFAs). This study aimed to assess the effectiveness of an~     energy-restricted diet, enriched in n-3 PUFAs and poor in n-6 PUFAs, on metabolic markers~     and clinical outcome of obese patients with psoriasis.~      Methods: Forty-four obese patients with mild-to-severe plaque-type psoriasis treated with~     immuno-suppressive drugs were randomized to assume either their usual diet or an~     energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6~     g/d). All patients continued their immuno-modulating therapy throughout the study. End-point~     measures included anthropometric, biochemical and clinical parameters at baseline, 3 and 6~     months.~   "
90184|NCT01876862|"~     During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral~     Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable~     reservoir.~      Recent studies showed that a low reservoir is associated to a spontaneous virologic control~     in three specific categories of patients:~        -  Elite Controllers: these rare patients are able to spontaneously maintain an HIV-RNA~          viral load below 50 copies/mL and elevated CD4 counts without any treatment. These~          patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV~          contamination but these haplotypes are very rare in the global population (0,3 %)~        -  Visconti patients: early-treated patients, during the primo-infection stage. After 3~          to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA~          viral load.~        -  Salto patients: these patients are treated a bit later compared to the Visconti~          cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below~          50 000 copies/mL. The follow-up of these patients showed the same capacity of control~          of the HIV infection for at least 2 years following treatment interruption.~      Taking into account these 3 categories of patients which common characteristics is a low~     reservoir, our objective is to answer the 2 following questions:~        1. Is it possible to discontinue the treatment in chronically-infected patients with a~          normal immune system and with an undetectable HIV-DNA reservoir?~        2. Is a low viral reservoir predictive of a treatment-free remission of the HIV infection~          in chronically-infected patients?~      The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of~     patients in success (i.e. able to maintain a virologic and an immunologic control of the~     infection) after treatment discontinuation, failure is defined as:~        -  An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4~        -  Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4~        -  Or the onset of an AIDS-related event~   "
90185|NCT01876849|"~     The aim of this study is to assess the long-term safety of exenatide in patients with type 2~     diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study~     H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies~     H8O-MC-GWAA and H8O-MC-GWAD.~   "
90186|NCT01876836|"~     1. i-gel~        2. C-LMA~      Compare the effect on gastroeosephageal reflux Postoperative complicatios.~   "
90187|NCT01876823|"~     Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause~     of disability and death in the elderly. Although a number of theoretical causes exist, the~     etiology of AD is still unknown. Consequently, the focus of treatments has been palliative,~     designed to ameliorate AD symptoms. Recent efforts, however, have revealed some surprising~     data suggesting that cholinesterase inhibitors (AchEIs), used over the last decade, and~     recently released memantine (an N-methyl-D-aspartate (NMDA) receptor antagonist), may confer~     protection to neurons. Thus, they may offer a slowing of cognitive decline and/or~     improvement in behavioral symptoms associated with memory impairment.~      Over the last decade, it has been well documented that mild cognitive impairment (MCI)~     increases the risk of conversion to AD and that coincident depression and MCI (Dep-MCI)~     further increases the risk 2 to 3 fold. The primary focus of this line of investigation is~     to treat the very high risk to dement patient population with Dep-MCI, before they develop~     AD, in the hopes of delaying AD onset.~      Memantine had not been studied in DEP-MCI patients. Since treatment of these patients with~     combined antidepressant and AChEIs has been associated with cognitive improvement in pilot~     studies, we explore whether treatment of DEP-MCI with memantine in addition to~     antidepressant treatment would benefit cognitive performance and lead to a low rate of~     conversion to dementia. We evaluate the cognitive and antidepressant benefit of combined~     open-label es-citalopram and memantine treatment over 48 weeks in a DEP-CI sample.~   "
90188|NCT01876810|"~     The purpose of this study is to investigate the effect of gemfibrozil on nicotine~     reinforcement and cue-elicited craving. Other objectives of this study include screening for~     the ability of gemfibrozil to aid smoking abstinence during a brief quit attempt and~     examining the validity of using laboratory measures of tobacco dependence to predict smoking~     abstinence. It is hypothesized that gemfibrozil will result in diminished nicotine~     reinforcement, an attenuated response to smoking cues, and an increase in smoking abstinence~     compared with placebo. It is also hypothesized that the laboratory measures will prove valid~     in predicting abstinence.~   "
90189|NCT01876797|"~     This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and~     prasugrel in healthy Korean male subjects.~      The study is open label, one sequence, crossover design. In period 1, a single oral dose of~     180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2,~     a single oral dose of 60 mg prasugrel will be administrated.~      After dosing each period, blood sampling for PK and PD assessment will be conducted.~        1. Blood Sampling Times~             1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose~             2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose~        2. Bioanalysis~             1. plasma Ticagrelor~             2. plasma AR-C124910XX (active metabolite of ticagrelor)~             3. plasma R-95913 (inactive metabolite of prasugrel)~             4. plasma R-13727 (active metabolite of prasugrel)~        3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)~        4. PK-PD Modeling analysis~   "
90190|NCT01876784|"~     The Study is designed to assess the efficacy, safety and tolerability of vandetanib 300 mg~     daily in patients with differentiated thyroid cancer that is either locally advanced or~     metastatic who are refractory or unsuitable for radioiodine (RAI) therapy.~   "
90191|NCT01876771|"~     Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis often delayed with~     advanced metastases at presentation. In select patient populations, radioisotope therapy has~     been shown to be a safe and effective palliative therapy. Lutetium-177 (Lu-DOTA-TATE) has~     been used at the Cross Cancer Institute to treat 91 patients with NETS since August, 2010.~     This study is being done because the investigators Lu-DOTA-TATE treatment is currently given~     under Health Canada's (HC) Special Access Programme (SAP), with each individual treatment~     requiring separate approval. HC has requested that the investigators conduct a clinical~     trial with Lu-DOTA-TATE, with the goal of receiving approval to use Lu-DOTA-TATE as a~     marketed treatment agent. There will be two groups of subjects: Group A (primary therapy)~     will have somatostatin receptor positive tumours; Group B (secondary therapy) will be those~     subjects who have currently been provided with Lu-DOTA-TATE under the SAP. All subjects will~     be treated in a therapeutic stage using 8-12 week dosing for 4 cycles followed by a~     maintenance stage using dosing at 22 to 26 week intervals for up to 8 cycles with a 22 to 26~     week follow up after the last dose. Safety will be assessed by vital signs, blood work,~     renal function and adverse event collection.~   "
90203|NCT01876615|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in~     healthy male volunteers~   "
90327|NCT01875159|"~     The purpose of this pilot study is to document the extent to which intermittent hypoxia~     persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect~     of caffeine treatment on the number of intermittent hypoxia episodes and the total number of~     seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.~   "
90192|NCT01876758|"~     Although electroconvulsive therapy (ECT) remains the most effective treatment for people~     with severe depression, patients may experience a significant degree of persistent and/or~     permanent memory problems following ECT. Many patients report the memory problems are the~     most disturbing and serious side effect of ECT, and that such effects impact their quality~     of life following treatment and their willingness to consent to further ECT needed to~     complete a treatment course or to maintain remission. New developments in the field of~     cognitive remediation have demonstrated the benefits of cognitive training to improve memory~     performance in various conditions, such as epilepsy. However, these strategies have never~     been applied to help patients regain memory after ECT. The investigators have designed and~     piloted a novel cognitive program specifically targeted to the cognitive effects of ECT,~     based upon a program tailored to people with seizure disorders, a group with memory problems~     very similar to people who undergo ECT. This Memory Training for ECT (Mem-ECT) is designed~     to help cognitive functions that may be compromised following ECT remain relatively~     preserved. In addition, the intervention attempts to help ECT patients quickly regain their~     general memory skills immediately following ECT. Recent results from our preliminary group~     of patients who underwent ECT and memory training at New York Presbyterian shows no overall~     decline in memory function following ECT. On the basis of these promising findings, the~     investigators propose a more rigorous and larger study to confirm whether this novel memory~     training program can help alleviate memory problems associated with ECT.~   "
90193|NCT01876745|"~     This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy~     of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding~     episodes and for the prevention of bleeding during surgery/delivery in patients with~     Glanzmann's thrombasthenia (GT)/Glanzmann's disease.~   "
90194|NCT01876732|"~     Vitamin B12 has several important functions in the body, two of which are production of red~     blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient,~     abnormal red blood cells form. These cells are called megaloblasts. The end result is a~     decreased number of red blood cells; a condition called anemia. Some symptoms of anemia~     include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in~     maintaining a healthy nervous system. Nerves are surrounded by an insulating material that~     helps them conduct impulses. Patients with low B12 levels who receive this vitamin in~     injection form, state that there quality of life is better. Anemia in Hemodialysis patients~     is treated with Epogen, a synthetic material which helps your body make blood cells. The~     investigators believe that if you have a low vitamin B12 level in your blood and the~     investigators give you the vitamin during dialysis your requirement for epogen will be lower~     and you will be able to produce blood cells better. When evaluating for Vitamin B12~     deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood~     test that will be performed and when this level is high and your vitamin B12 level is in the~     low normal range the investigators can make a diagnosis of vitamin B12 deficiency.~   "
90195|NCT01876719|"~     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced~     titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio.~     One-hundred twenty (120) patients are planned to be randomized. Each patient will receive~     AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.~   "
90196|NCT01876706|"~     The purpose of the study is to evaluate procedure tolerability and surgical recovery~     following the UroLift® system procedure when conducted with local anesthesia in subjects~     with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking~     at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.~   "
90197|NCT01876693|"~     The purpose of the study is to determine whether prophylactic gastrostomy leads to less~     treatment interruption and provide better quality of life in head and neck cancer patients~     receiving chemoradiotherapy.~   "
90198|NCT01876680|"~     The purpose of this study is to investigate the effects of specific neck/shoulder muscle~     exercises on pain, function, biochemistry and psychological factors in women suffering~     chronic neck/shoulder pain.~   "
90199|NCT01876667|"~     Clinical pharmacy specialists are in an ideal position to assist medical teams in the~     management of patients with ischemic stroke. Given their extensive and specialized knowledge~     regarding medication efficacy, safety, and cost-effective use as well as their ability to~     critically review, interpret and apply the results from clinical studies to patient care,~     clinical pharmacy specialists have the potential to have a significant impact on stroke care~     delivery. There are numerous opportunities for clinical pharmacy specialists to become more~     extensively involved in the delivery of care to these high-risk patients. However, to-date~     there are few studies demonstrating the impact of clinical pharmacy specialists on outcomes~     of patients with stroke Stroke is the third leading cause of death in the United States~     (U.S.) and the most common life-threatening neurologic disorder.1 Stroke is a leading cause~     of long-term disability and results in significant individual and societal financial~     burdens. In 2006, stroke accounted for 1 of every 18 deaths and ischemic stroke accounted~     for 87% of all strokes.1 In the U.S., out of the approximately 795,000 people who develop a~     stroke each year, approximately 185,000 (23%) are recurrent events.1 After the first year,~     the average annual risk for recurrent stroke is 4%.2 Patients who survive at least 30 days~     after a first-ever stroke, have an average annual risk of death of 9.1%, much of the risk~     due to nonstroke cardiovascular disease.~      Despite the evidence supporting the use of various therapeutic interventions within the~     ischemic stroke population, a significant proportion of patients continue to have~     uncontrolled risk factors and remain undertreated.26-30 A recent prospective study of more~     than 4933 high-risk patients reported that, as compared to patients with coronary artery~     disease, patients with cerebrovascular disease are undertreated and thus less likely to~     achieve blood pressure (45.3% vs. 57.3%; p<0.001) and lipid (19.4% vs. 30.5%; p<0.001)~     targets.28 Although the reasons for the so-called treatment gap have not been explored~     specifically within this population, data from studies within the coronary artery disease~     population suggest that provider, patient and health care system factors likely all~     contribute.~      This will be the first, prospective, randomized study to evaluate the impact of a clinical~     pharmacist disease management program on both surrogate and clinical outcomes for patients~     with non-cardioembolic ischemic stroke.~      This will be a randomized, controlled study comparing a clinical pharmacist-led disease~     management intervention by the Clinical Pharmacy Cardiac Risk Service (CPCRS) to usual care~     (UC).~   "
90200|NCT01876654|"~     Patient specific instrumentation is an alternative to conventional intra- and~     extra-medullary guides to perform the femoral and tibial cuts in total knee replacement~     (TKR).~      This instrumentation could provide a better alignment of a TKR, reduce blood losses and~     operative time, and improve clinical outcomes.~      The primary goal of this study is to compare the femorotibial mismatch angle of two groups~     of patients: patients undergoing posterior stabilized, mobile bearing TKR with conventional~     P.F.C. Sigma® HP instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient~     undergoing TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.~   "
90201|NCT01876641|"~     The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus~     Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.~   "
90204|NCT01876602|"~     The specific aims of this study are to: 1) evaluate the impact of a novel intervention~     delivered via school-based physical education (PE) on adolescents who have a high~     sensitivity to exercise-induced negative affect; 2) determine whether adolescents' tendency~     to feel uncomfortable during exercise is a stable trait that persists even in the face of an~     intervention; and 3) compare and contrast three alternative methods of measuring~     adolescents' sensitivity to exercise-induced affect.~      Healthy middle-school students who do not participate in team or individual competitive~     sports will be recruited and assessed to determine their existing predisposition toward~     exercise (i.e., reluctant exercisers and latent exercisers). The assessment will be~     conducted using three methods that have been used to measure individuals' propensity to~     experience positive affect in the face of a stimulus: 1) a pencil-and-paper assessment that~     measures tendency to respond to a challenge with positive affect; 2) electroencephalogram~     (EEG) to ascertain frontal cortical asymmetry; and 3) empirically assessed affective~     response to a standardized exercise task. Reluctant and latent exercisers will be assigned~     in equal numbers to one of two conditions. One condition will implement a PE-based~     intervention that differs from the traditional approach in that students will be instructed~     to exercise at an intensity that has been determined to elicit positive affect in that~     individual (based on baseline testing). In the other condition, students will be instructed~     to exercise at an intensity derived from standard formulas typically used in exercise~     prescriptions. It is hypothesized that the non-traditional approach will increase reluctant~     exercisers' enjoyment of PE and also their level of participation in physical activity~     outside of PE. The latter will be determined using portable monitors (accelerometers) worn~     at baseline, after the intervention, and again 1 year after the end of the intervention.~   "
90205|NCT01876589|"~     The purpose of this study is to examine the improvement of myocardial blood flow induced by~     regained vasomotor functions of the stented coronary segment after resorption of BVS over~     time.~   "
90206|NCT01876576|"~     This study will evaluate the expansion of dietary options from clear liquids the entire day~     to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with~     MoviPrep® and its effect on preparation quality for colonoscopy.~   "
90207|NCT01876563|"~     The aim of this study is the comparision between the effects of vitamin D or placebo~     supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase~     activity in patients with type 2 diabetes~   "
90208|NCT01876550|"~     The primary objective of this study is to determine the comparability of the safety and~     efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily~     infected traumatic skin lesions. It will also be determined whether the efficacy of each of~     the active treatments is superior to that of the vehicle cream (placebo).~   "
90209|NCT01876537|"~     THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's~     well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological~     pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta~     P.J. et al., 2005). Clinical manifestations of pilonidal sinus disease mainly due to the~     appearance of inflammation in it.~      The main approach in the complex treatment of this group of patients is to execute radical~     surgery. The guiding principles in it are adequate sanation and drainage of purulent focus.~      Despite the fact that this disease is the subject of numerous medical journals, monographs,~     research works, masters and doctoral theses, frequency of unsatisfactory outcomes remains~     high (recurrence - from 10% to 19%, wound inflammation - 20-30%). In this case terms of~     stationary and out-patient treatment increase till 30-70 days (G.I. Vorobjov, 2006; B.M.~     Dacenko et al., 2004; Cubukcu А., 2001, Perruchoud С, 2002).~      The frequency of unsatisfactory results after excision of SPD directly depends on the kind~     of surgery. After palliative surgery (incision and drainage of abscess) in 11.7 - 25.2% of~     patients occurs recurrence of the disease (McCallum I., King P.M., Bruce J., 2007;), for the~     open wound healing recurrence occur in 3-8% of the operated. For primary wound healing in~     7,5-9,7% required re-surgery (V.K. An, 2003; A.A. Kartashev, 2011).~      Sacrococcygeal pilonidal sinus disease overwhelmingly affects people, mostly young working~     age, and treatment failure leads to long-term temporary disability of patients.~      In the last few years continue to discuss methods of one-time or multi-stage radical~     surgical treatment of pilonidal sinus, but to date there is no single approach to the choice~     of surgical treatment for this disease (V.L. Denisenko, 2008).~      Success of surgical treatment of SPD depends on the development and introduction of new~     devices and techniques exist to produce convergence and immobilization of the wound edges,~     thereby obtaining its primary healing and a significant reduction of wound surface.~      The high frequency of the disease and postoperative complications, as well as long-term~     temporary disability of patients demonstrates the relevance of the development of modern~     methods of radical surgery of sacrococcygeal pilonidal sinus disease (V.I. Pomazkin, 2008).~      AIM OF RESEARCH. The aim of our research is to improve the results of complex radical~     surgical treatment of patients of sacrococcygeal pilonidal sinus disease through the~     development and introduction of new devices and techniques for convergence and~     immobilization wound edges.~      TASKS OF RESEARCH.~        1. To conduct a comparative analysis the most common surgical treatment of SPD in the~          frequency of complications in the intra- and postoperative periods.~        2. To develop a device for convergence and immobilization wound edges in patients with~          SPD.~        3. To analyze the effectiveness of the developed techniques and devices in comparison with~          traditional surgical treatment.~        4. To make practical recommendations on the options and methods of using the developed~          methods and devices.~      NOVELTY OF RESEARCH. For the first time, based on the design and creation of an~     approximation-immobilization device (RU Patent № 112020, Bull. № 1, 01.10.2012) will be~     improved the surgical treatment of patients with this pathology, clinical and anatomical~     study of the proposed device for different configurations of gluteal-sacrococcygeal region,~     as well as the analysis and justification of the basic parameters of wound (length, depth~     and width of the wound, the number of stitches, the complication rate , the area of the~     wound).~      Developed a method of closure of the wound defect after radical excision of pilonidal sinus~     by Krivonosov-Brezhnev (RU Patent № 2,464,943, Bull. № 30 from 10.27.12.), that~     significantly reduces the risk of postoperative complications in patients with acute~     inflammation of the SPD.~      For the first time an analysis of postoperative period in patients operated with the~     proposed methods compared with traditional methods of surgery was performed.~      POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment~     process of coloproctological departments at all levels, as well as the learning process of~     medical schools.~      EXPECTED EFFECTIVENESS.~        1. Scientific and technical effect: developed new techniques and devices for convergence~          and immobilization wound edges used for the treatment patients with SPD.~        2. Medical and social effects: the introduction into clinical practice of the developed~          techniques and devices will improve the results of surgical treatment of patients with~          SPD by rigid fixation of wound edges, by reducing the time of postoperative wound~          healing, by decreasing the risk of complications in the early postoperative period.~   "
90210|NCT01876524|"~     The purpose of this study is to study the efficacy and security of noninvasive brain~     stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other~     psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.~   "
90211|NCT01876511|"~     This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T~     cells) is effective (anti-tumor activity) and safe in three different patient populations.~     These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative~     colon cancer, and 3. patients with other MSI positive cancers.~   "
90212|NCT01876498|"~     The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by~     patient with Morbus Dupuytren and to build up a register.~   "
90213|NCT01876485|"~     This hybrid effectiveness/implementation trial will be conducted in two phases over four~     years. In Phase 1, the investigators will evaluate the process of implementing a~     collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care~     [EPIC]) personalized to self-reported patient activation and functional health literacy~     (FHL) levels into routine primary care practices. In Phase 2, the investigators will conduct~     a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care~     (EUC). In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284~     Veterans with poorly controlled diabetes defined by average hemoglobin A1c over the last six~     months of >= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be~     allocated evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing~     on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans,~     4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6)~     Reviewing and Planning for the Future. After each group session, a one-on-one session~     between a designated PACT member and patient participants will focus on collaborative~     goal-setting. Patients randomized to EUC will be referred to the PACT RN Care Manager for~     diabetes management, and will also receive a packet of educational materials regarding~     diabetes management, including a letter delineating the diabetes management resources~     available at their facility. Study measurements using self-reported questionnaires and blood~     tests to assess blood sugar control will be obtained at baseline, post-intervention, and~     post-six month maintenance period.~   "
90214|NCT01876472|"~     Adult recipients of cochlear implants (CI) generally loose interest in listening to music.~     This may be due to the rather limited spectral resolution of CI. However, child~     CI-recipients, if offered the opportunity, like to listen to music. They participate~     actively in musical acitivities, such as singing, dancing or playing an instrument. Thus,~     there seems to be a fundamental difference in the music perception of people who receive CI~     as child or as adult.~      This study assesses music perception skills of child, teen and adult cochlear implant~     recipients in settings with simple tone sequences and in a more complex, melodious context.~   "
90215|NCT01876459|"~     Patients with memory disorders are experiencing different trends which are difficult to~     predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not~     easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and~     can improve the diagnosis but there are not specific enough of one of those two pathologies.~      Lewy body disease is characterized by the presence of particular structures in patient's~     brain, called Lewy body, composed of a protein called alpha-synuclein. The aim of this~     study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement~     could allow us to differentiate patient with Alzheimer's disease from those with Lewy body~     disease.~   "
90216|NCT01876446|"~     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating~     patients with small cell lung cancer that has returned after a period of improvement.~     Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
90419|NCT01873729|"~     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective~     in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that~     increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a~     kappa opioid receptor antagonist, it increases dopamine in the brain.~      We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults~     with ADHD.~   "
90217|NCT01876433|"~     Objective: The objective of the study is to assess the structural and functional cardiac~     effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart~     failure.~      Design: We are planning a study aiming at establishing proof of concept that treatment of~     patients with HF with Mirabegron has significant positive effects, as assessed by clinical~     and biochemistry measurements, but not by hard endpoints. We are performing a combined~     dose-finding - chronic efficacy study.~      The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is~     6 months. 70 patients with chronic heartfailure will be included.~      Specific aims~        1. Determine safety of administration of Mirabegron to patients with heart failure.~        2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac~          structural remodelling in patients with heart failure.~        3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by~          questionnaires and 6 min walk test in patients with heart failure.~        4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and~          arrhythmias in patients with heart failure.~        5. Determine effects of Mirabegron on circulating biomarkers in patients with heart~          failure.~   "
90218|NCT01876420|"~     To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.~   "
90219|NCT01876407|"~     The purpose of this study is to evaluate the effectiveness of using to low intensity laser~     as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy~     and chemotherapy.~   "
90220|NCT01876394|"~     The purpose of the study is to examine the effect of consuming 50g of fat from 5 different~     sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure~     and blood glucose levels. It is hypothesized that butter will have the most detrimental~     effect on acute vascular function. Canola, grapeseed and chia oil with their decreased~     content of SFA are hypothesized to impair vascular function to a lesser extent.~   "
90221|NCT01876381|"~     To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in~     patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using~     variables, such as daily urine volume and increase in interval body weights between~     hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days~     of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period~   "
90222|NCT01876368|"~     This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in~     essential hypertensive patients not adequately responsive to olmesartan~   "
90223|NCT01876355|"~     Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke~     delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of~     GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that~     this therapy is effective and safe.~      Objective: The objective of this study is to compare the effect of clonidine with placebo on~     the occurrence and duration of delirium in mechanically ventilated ICU patients.~      Study design: Prospective randomised double-blind placebo controlled intervention study in~     115 patients.~      Study population: All patients >18 years old, intubated mechanically ventilated and sedated~     at inclusion.~      Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen.~     Comparison: NaCl 0,9 % infusion as placebo.~      Main study parameters/endpoints: The main study parameter is the total number of awake and~     delirium-free observation periods the first 7 days after randomisation. An observation~     period is a nursing shift of 8 hours.~   "
90224|NCT01876342|"~     Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair~     without mesh or laparoscopic technique with mesh have been advocated in the treatment of~     sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open~     technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis~     is that laparoscopic technique is less painfull than open surgery for repair of sportsman's~     hernia.~   "
90225|NCT01876329|"~     A review of the literature reveals that very few studies have assessed the potential~     co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While~     Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin~     B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made.~     While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric~     parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively,~     no additional testing was implemented to determine the significance, specifically whether or~     not the presence of anti-GPC Ab related to vitamin B12 deficiency.~      The purpose of this study is to determine the prevalence and metabolic significance of~     anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group~     of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither~     RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the~     current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels~     (Methylmalonic acid) will be tested.~   "
90226|NCT01876316|"~     The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese~     Healthy Subjects~   "
90227|NCT01876303|"~     This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing~     sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify~     biomarkers related to cancer.~   "
90228|NCT01876290|"~     The investigators want to test if it is indicated to associate dexamethasone and ondansetron~     in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.~   "
90246|NCT01876056|"~     While Cognitive behavior therapy for psychosis (CBTp) is now established as an effective and~     evidence based therapy for psychotic illnesses in the west and is recommended by the~     national organizations both in Europe and in the USA. However, CBT remains limited to the~     western clients. We have adapted CBT for psychosis in Pakistan for use with local clients.~     Initial evaluations have found that these therapies are effective. Due to the financial~     restraints we would like to test a brief version of the Culturally adapted CBTp (CaCBTp) in~     Pakistan. We want to see if brief CaCBTp (6 sessions of CBT) would be effective in non~     western cultures in educing symptoms of schizophrenia. This study will test brief CaCBTp~     against care as usual in Pakistan in secondary care.~   "
90229|NCT01876277|"~     In adolescence, the effects of cancer and its treatment can lead to bodily changes such as~     hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments~     for childhood cancers improve and life expectancy increases, more adolescents have to deal~     with the effects of cancer and the treatment on their bodies throughout their lives.~      Body image can be defined as The mental image we hold of our bodies. There are two aspects~     to this, how we see our size/shape/weight etc, and then how we feel about this. Often the~     actual change in body does not always predict how people cope with it, or how they feel~     about it.~      Prior research suggests, and clinical experiences suggests that body image issues arise for~     at least some adolescents with cancer, however it is unknown whether a disturbance in body~     image is seen as distressing for the adolescent, or how this affects them psychologically.~      Body image problems were always seen as a typically female problem, and therefore~     researchers have often neglected to look at the issues for men. There is currently no~     research specifically addressing the impact of body image in adolescent boys with cancer.~      This research will involve interviewing adolescent males with cancer with the aims to find~     out;~        1. What the body image issues are, if any for this group.~        2. How any body image issues might affect them, particularly psychologically.~        3. What helps or hinders this group maintain a positive body image, or stop it having a~          negative impact on them psychologically.~      It is hoped that this will help to inform psychological treatments for body image~     difficulties in the future.~   "
90230|NCT01876264|"~     The trial will investigate if removing an additional length of small bowel will result in~     lower risk of recurrence at the surgical join (anastomosis), thereby decreasing the need for~     further surgery in the future.~   "
90231|NCT01876251|"~     This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel~     combination in patients with advanced breast cancer. Preliminary information about the~     efficacy of the combination will also be collected.~   "
90232|NCT01876238|"~     This research study will examine how patients with advanced breast cancer and their oncology~     team communicate and plan ongoing care.The purpose of this study is to find out more about~     care planning during advanced breast cancer. The study will see if certain aspects of~     communication make a difference in how patients understand their illness.~   "
90233|NCT01876225|"~     The use of forced coughing during cervical punch biopsy may reduce pain & discomfort~     associated with the procedure.~   "
90234|NCT01876212|"~     Current therapeutic approaches available for patients with advanced-stage melanoma remain~     inadequate, and existing approaches including those involving immunotherapy with cytokines~     and/or targeted strategies have resulted in disappointingly low rates of durable and~     complete responses. Correcting immune dysfunction in advanced-stage melanoma patients using~     tyrosine-kinase inhibitor (TKI) such as dasatinib is proposed to relicense the patient's~     immune system to respond optimally to specific immunization. The integration of antigens~     expressed by tumor-associated blood vessel cells provides a means to selectively target the~     genetically-/antigenically-heterogeneous population of tumor cells in the advanced-stage~     melanoma patient.~      This is a single-center, prospective randomized Phase 2 trial evaluating the activity,~     safety and immune effects of dasatinib given in combination with an autologous type-1~     polarized Dendritic Cell (αDC1) vaccine. The current trial represents a randomized Phase 2~     study to determine the activity and safety of intradermal (id) administration of αDC1s~     loaded with a mixture of six TBVA-derived peptides at the time of, or immediately after, an~     initial therapy cycle with the TKI dasatinib.~      Dasatinib will be administered at the standard dose and schedule recommended by the FDA (70~     mg BID). The autologous type-I DC vaccine will be administered either prior to, or~     concomitant with, the initiation of dasatinib administration. All patients will receive~     dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting~     approximately every 12 hours, at the same time each day.~      The DC vaccine will be administered by a single intradermal injection of approximately 10e7~     cells, with all the DCs being administered on days 1 and 15 of every cycle on an outpatient~     basis in the University of Pittsburgh Clinical and Translational Research Center~     (UPCI-CTRC).~      Patients on Arm A will start dasatinib administration on cycle 2, day 1 (week 5), while~     those patients in Arm B will start dasatinib administration on cycle 1, day 1 (week 1).~      Men and women at least 18 years of age must be HLA-A2+ and have histologically confirmed~     melanoma that is metastatic (Stage IV) or unresectable Stage IIIB/C and for which standard~     curative or palliative measures do not exist or are no longer effective.~   "
90235|NCT01876199|"~     In this research, the investigators want to see if early detection of HIV infection can be~     improved by testing young adults who seek urgent health care from pharmacies and healthcare~     facilities with symptoms similar to those people get with recent HIV infection.~      Specific objectives:~        1. What proportion of people presenting with these symptoms are HIV positive at the point~          of seeking urgent health care?~        2. What proportion of those who test negative or where the result is unclear (one rapid~          test positive and one negative) at first rapid HIV testing, will test positive two~          weeks later?~        3. What is the best way (SMS, phone call or home visit) to remind people to come for the~          second test after two weeks?~        4. Will young adults who seek urgent health care for fever, body pains, diarrhoea or an~          STD from pharmacies or health facilities find it acceptable to be invited for an HIV-1~          test at the time of health care seeking?~      Hypotheses~        1. Targeted screening for AHI among patients seeking health care for symptoms compatible~          with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1%~          of those screened.~        2. Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1~          testing 2-4 weeks after initial health-care seeking, relative to standard practice~          (i.e., recommendation to return for testing on a given date).~   "
90236|NCT01876186|"~     To investigate whether prolonged period of treatment (6 months) can have a better~     therapeutic outcome than conventional period (3 months) of antimuscarinics.~   "
90258|NCT01875900|"~     Simulation-based training has been widely implemented in medical education. According to~     educational theories, simulation-based medical education (SBME) is associated with~     significant advantages, which has been investigated and proved by many studies. However, the~     value of SBME in comparison to other instructional methodologies remains largely unknown.~     Therefore, the aim of this study is to directly compare two instructional methods for~     neonatal resuscitation training.~   "
90259|NCT01875887|"~     Combined application of surgery planning software and rapid prototyping technology and~     preshaped titanium plates can effectively promote the accuracy of the diagnosis and~     treatment of bilateral maxillofacial post traumatic deformities, reduce operation time and~     improve surgical effect.~   "
90260|NCT01875874|"~     This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in~     subjects with acute liver failure (ALF) compared to matched historical controls.~   "
90261|NCT01875861|"~     The purpose of this study is to test an approach for implementing guideline recommendations~     for assessing and managing metabolic side effects (including weight gain, diabetes, elevated~     lipids) in patients prescribed antipsychotic medications.~   "
90237|NCT01876173|"~     Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of~     cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers~     high-risk patients a treatment option to reduce the incidence of SCD by delivering an~     internal shock to restore a normal rhythm, if needed. Definitive evidence has established~     the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a~     primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice~     guidelines define the criteria to determine patient ICD candidacy for primary prevention.~     However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes,~     renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and~     risks of an ICD can become complex, particularly when competing mortality risks are present.~     Research has recognized human costs associated with device complications and shocks~     affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The~     complexities surrounding the long-term benefits/risks, complications, replacements, and~     shocks, warrant decision support to prepare patients to make decisions. In Canada, there is~     no clear framework to support patients' decision-making in the context of ICD treatment~     options. Decision support, using a decision aid, could moderate treatment related~     uncertainty and prepare patients to make active, informed, quality decisions.~      Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making~     (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to~     determine the feasibility of conducting a trial.~   "
90238|NCT01876160|"~     The sensory and motor perception thresholds can influence the therapeutic effects of~     Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of~     sensory perception and the threshold of motor response in young and elderly subjects of both~     sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal~     groups of young and elderly subjects. Half of the individuals in each group were stimulated~     with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on~     the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was~     identified as the first sensation of increased current intensity and the threshold of motor~     response as the minimum muscle contraction detected. The results were submitted to ANOVA~     test, followed by the Tukey test, with a significance level of 5%.~   "
90239|NCT01876147|"~     Vision testing is a fundamental part of every optometry and ophthalmology assessment.~     Traditional vision testing charts are not able to measure vision below a certain level.~     Vision in this range is classified as counting fingers (CF), hand movements (HM) and light~     perception (LP). These measures are not very accurate or easily quantifiable. They are also~     poorly understood in terms of impact on quality of life. This study aims to assess new~     methods for measuring the vision of patients with very low vision.~   "
90240|NCT01876134|"~     Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical~     and surgical conditions. Recent studies have demonstrated that the occurrence of AKI~     significantly increase the risk of adverse outcomes. Despite the advanced in modern~     medicine, the interventions for AKI are not improved. One major reason of the failure to~     shift therapeutic progress is the clinicians' widespread dependence upon serum creatinine,~     an unreliable marker during acute changes of renal function, for the diagnosis of AKI.~      In the past decade, over 20 unique biomarkers of AKI had been explored. Among them,~     neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury~     molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.~      Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein,~     belongs to the CCN family. It regulates a broad spectrum of cellular activities, including~     cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis,~     and extracellular matrix production of multiple cell types. By the kidney~     ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in~     the renal outer medulla. That portion of the kidney is corresponding to the area of~     marginally oxygenated under normal condition and most tubular injury following renal~     ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and~     also in urine following injury, making it a potential marker of AKI.~      Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With~     spectral analysis of the pulse waves, researchers started to observe the pulse wave~     harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries~     significantly reduced the second harmonic component of the pressure pulse at the caudate~     artery. Ligating the artery toward the spleen prominently reduced the third harmonics~     component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure~     wave revealed that individual organs might have their own natural frequencies. These~     observations suggested that individual vascular beds exert independent, frequency-specific,~     effects on the peripheral pressure wave.~      Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown~     that AKI after cardiac surgery is relatively highly prevalent and prognostically important.~     Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass~     machine ('on-pump').~      Based on the evidence from cell culture study and animal study in the literature, we~     hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this~     project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We~     will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients~     undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of~     patients with AKI, either singly or in combination with NGAL. By the way, we also try to~     correlate the changes in those biomarker with a potential new tool：harmonic analysis of~     arterial pressure pulse waves. We have special interest in following the time course of~     changes in biomarker and correlate with changes in pulse analysis. Physiological parameters~     of vascular compliance and regional blood oxygen saturation will be correlated concurrently.~     It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing~     our ability to develop beneficial therapies.~   "
90241|NCT01876121|"~     This study is to assess the safety and efficacy of celecoxib on the pain relief from acute~     pain.~   "
90242|NCT01876108|"~     The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease~     (NAFLD) is controversial.~   "
90243|NCT01876095|"~     Nursing home residents are among the frailest patient groups with a high number of~     co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often~     overprescribing) is one of the major problems in the nursing home population increasing the~     number of adverse drug reactions, falls, hospital admissions, mortality as well as having an~     impact on health care utilization. Multidisciplinary medication reviews have a great~     potential to reduce inappropriate medication use. The purpose of this study is to determine~     the efficacy of a multidisciplinary medication review model focussing on discontinuing~     inappropriate medication in a cluster randomized controlled trial in 600 nursing home~     residents. The primary outcome measure is the difference in proportion of residents who~     successfully discontinued medication between intervention and control group after four~     months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal~     events related to the discontinued medication, death, referral to hospitals and quality of~     life.~   "
90244|NCT01876082|"~     Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential~     local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at~     diagnosis is about 30 years.~      Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid~     tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical~     treatment. In these clinical situations, only a medical treatment may achieve tumor control~     and quality of life maintenance. Place of systemic treatments in the management of desmoids~     tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is~     actually the best evaluated combination, which allowed observing objective response rate~     between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity.~      Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type~     receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently~     under clinical development in humans in the treatment of several tumor types.~   "
90245|NCT01876069|"~     Background:~      Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate~     diagnosis of a pancreatic mass is important to direct patient management. Endoscopic~     ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling~     pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some~     limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To~     overcome these limitations, a new needle device with ProCore reverse-bevel technology was~     developed recently.~      Aims:~      The objective of this prospective study is to compare the rate of diagnostic sufficiency in~     the EUS sampling by using newly developed ProCore needle with conventional FNA needle in~     suspected unresectable pancreatic cancer. We will also compare the safety, the yield of~     histologic core tissue and the cost-effectiveness between these modalities.~   "
90262|NCT01875848|"~     This study compares buprenorphine/naloxone to opioid dose escalation among patients with~     poorly controlled non-cancer pain on 30-100 mg daily morphine equivalent opioid dose.~   "
90516|NCT01872455|"~     n-3 Polyunsaturated fatty acids (PUFAs) supplementation reduces systemic inflammation and~     improves renal and cardiovascular prognosis in kidney transplant recipients. A good patient~     compliance is often difficult to obtain because bad tasting fish oils are used as n-3 PUFA~     source. Therefore, we explored whether n-3 beneficial effects can be obtained by~     administering a diet based on n-3 rich foods.~   "
90247|NCT01876043|"~     Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the~     basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma~     / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic.~     Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by~     well-differentiated component associated with a contingent sarcomatous differentiation and~     fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development~     is very long asymptomatic. At diagnosis, tumor volume is often very important making~     surgical removal impossible in a high proportion of cases. Operable tumors have also a risk~     of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only~     treatment of these advanced forms. However, the currently available drugs (adriamycin,~     ifosfamide) have only very limited effectiveness. Progression-free survival of patients does~     not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of~     two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes~     encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of~     JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The~     plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional~     activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in~     vitro models of LDD. plitidepsin could represent the treatment of choice for patients with~     advanced LDD. The objective of this study is to evaluate the anti-tumor activity of~     plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or~     metastatic.~   "
90248|NCT01876030|"~     The investigators hypothesize that the gait pattern of following the utilization of a~     functional electrical stimulation device will be much improved when compared to the effect~     of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early~     stages following stroke.~   "
90249|NCT01876017|"~     This Study is single arm, single center trial to check the safety and efficacy of Autologous~     Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF~   "
90250|NCT01876004|"~     Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy~     if the complementary use of Methotrexate could provide better results. We evaluate the~     success of treatment and the time required for titers of β-hCG to become negative. Methods:~     A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients~     will be divided into two groups: in one patients will be administered a single intramuscular~     dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo~     intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day.~     When the decline of beta-hCG titers was > 15% in this interval, the patient was followed~     with weekly dosing of β-hCG until the titers become negative. The criterion of success is~     when the β-hCG was negative. The treatment failure occurs when surgery was necessary.~   "
90251|NCT01875991|"~     The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis~     (PsO) patients who self inject etanercept for one of two experimental autoinjectors.~   "
90252|NCT01875978|"~     Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators~     have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth~     factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel~     role in cardiovascular protection.~   "
90253|NCT01875965|"~     Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with~     cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial~     esthetics in the final phase treatment. A setback of mandible by bilateral sagittal split~     osteotomy (BSSO) along with maxillary osteotomy is usually performed when large skeletal~     discrepancies or associated mandibular deformities (e.g., asymmetries, canting of the~     mandibular occlusal plane) are present. Although the surgical technique of BSSO is~     well-developed, the neurosensory disturbances of the inferior alveolar nerve (IAN) remain~     one of the major postoperative complications. The purpose of this study is to identify the~     risk factors of IAN disturbances after BSSO and in turn to help clinicians to avoid such~     complication and to raise the satisfaction level of patients.~      Design: Prospective prognosis study. Setting: Chang Gung Craniofacial Center, Taoyuan.~     Patients: Two hundred Taiwanese patients with nonsyndromic CLP (age, >16 for females, >18~     for males), who will undergo a BSSO as a part of the correction of their dentofacial~     deformities Measurements: All patients will undergo subjective (e.g., questionnaire) and~     objective (e.g., 2-point discrimination, light touch detection, and sharp/blunt detection)~     neurosensory assessments before surgery, and 1, 3, 6, 12 and 24 months after surgery. Cone~     beam computed tomography is performed before surgery and 1 week after surgery.~     Peri-operative factors including type of BSSO, extent of surgical correction, extent of~     split and fixation screws, concomitant genioplasty or third molar extraction are assessed.~     Patient-related factors including age, gender, bone quality of inferior alveolar canal are~     recorded as well.~      Data Analysis: Univariate and multivariate analyses will be performed. Statistical~     significance is assumed for a p value of less than 0.05.~   "
90254|NCT01875952|"~     The purpose of this study is to determine of once identified to the subjects infected with~     human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat~     her with isoniazid for six months, measuring the production of Interferon range pre and~     posttreatment, to evaluate this way the result of the treatment on the immune response~   "
90255|NCT01875939|"~     This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and~     determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to~     WCK 771 800 mg (intravenous, QD dose).~      This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK~     2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771,~     IV to WCK 2349, oral) in future clinical trials in patients.~   "
90256|NCT01875926|"~     The overall aims of the study are:~        -  To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i)~          local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of~          ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations~          after intravenous administration.~        -  To further determine the safety and local and systemic tolerability of ALX-0171.~        -  To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of~          ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).~   "
90257|NCT01875913|"~     The investigators will work with one of Vitality's partner corporations to test whether~     curiosity can motivate employees to follow through on their virtuous intentions and complete~     their annual health risk assessment (VHR). Employees will receive email messages that~     contain either a curiosity-inducing question or a standard encouragement message. The~     investigators predict that presenting people with curiosity-arousing questions will make~     them more likely to complete a health risk assessment, as compared to standard messages.~   "
90263|NCT01875835|"~     Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion~     strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is~     more effective than thrombolytic regimens in reducing adverse events, including death.~     Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The~     effectiveness of DES to reduce restenosis and the need for revascularization compared with~     bare-metal stents (BMS) has been documented in randomized controlled trials. The~     first-generation DESs implanted in STEMI have been associated with delayed healing and~     incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of~     dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been~     improved the drug and polymer, which have been proved to improve neointima healing compared~     with the first generation DESs.~      However, the difference of strut coverage between EES and BMS implanted in STEMI patients is~     unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up~     in EES and BMS implanted in patients with STEMI by optical coherence tomography.~   "
90264|NCT01875822|"~     Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder,~     continues to challenge mental health professionals in their search for better treatment~     options in the community. In the present study, the investigators hypothesized that in~     patients diagnosed as schizophrenia, adjunct treatment with Curry extract from the plant~     labeled by botanists as Curcuma Longata, formulated as Super-Curcumin@ , would bring about~     :1)positive behavioral changes in areas of socialization, emotional well-being, verbal~     communication and motivation; 2)improvement in measures of memory. Throughout the study, the~     proprietary product, Super-Curcumin@ consisting of Curcumin C-3 complex combined with the~     black pepper extract Bioperine to boost the effects of Curcumin. The study was developed to~     examine whether Curcumin's interaction with the two major signal pathways in the brain~     regulating brain-behavior: the epigenetic signal (histone modification) and the~     anti-inflammatory signal (inducible nitric oxide synthetase)in preclinical models is~     translated to beneficial effects in the treatment of schizophrenia.~   "
90265|NCT01875809|"~     Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is~     known regarding the patient or procedural characteristics influencing the outcome. None of~     the detectable variables like number of ablation points, temperature rise, impedance drop,~     have been shown to correlate with the blood pressure (BP) reduction. In this study, the~     investigators assess different patient and procedural characteristics, like exact patient~     medication, stress hormones, heart rate variability, and focus on the change of the~     catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP~     ablation. The investigators hypothesize the correlation between reduction of catecholamine~     spill-over due to denervation and the BP reduction. In this study, the investigators will~     assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.~   "
90266|NCT01875796|"~     This project tests the feasibility and utility of a novel, integrated approach to treatment~     of patients with cannabis use disorder (CUD) and anxiety disorders.~   "
90267|NCT01875783|"~     The purpose of this protocol is to determine whether point of care optical coherence~     tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary~     diabetes care visits increases rates of retina specialist eye care for patients with~     diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided~     referral algorithm will enable identification of patients at risk for vision loss from~     diabetic macular edema and facilitate direct referral to retina specialists for more timely~     evaluation and treatment.~   "
90268|NCT01875770|"~     This research is being done to assess the long term prognosis of patients treated with~     ranibizumab for edema due to retinal vein occlusion.~   "
90269|NCT01875757|"~     A phase III multicenter randomized double blind clinical trial will be conducted. After~     obtaining written consent the infant will be randomized, during the first two weeks of life,~     to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.~      Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric~     measurements and a questionnaire about health issues. A blood sample will be obtained at~     baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH~     vitamin D, and calcium.~      Healthy term born infants of appropriate size for gestational age will be included. We will~     need to include 359 children in each group.~      The primary objective of the study is to decrease the proportion of infants with acute~     bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D.~     Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases~     the proportion of infants with upper respiratory tract infections, the proportion of~     children under one year of age hospitalized for acute bronchiolitis, and the demand on the~     healthcare system due to respiratory infections and absences from work for parents and~     achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.~   "
90270|NCT01875744|"~     Background:~      Aim:~      Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the~     maintenance treatment of functional constipation in children.~      Study design:~      Randomized, open-label trial.~      Randomized, double-blind, placebo controlled trial.~   "
90271|NCT01875731|"~     The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in~     children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will~     reduce antibiotic use as compared to standard care practice (current guidelines for CAP).~   "
90272|NCT01875718|"~     The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess~     the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy~     women. The safety and tolerability of UC1010 is also evaluated in study part 1.~      In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on~     premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during~     the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the~     patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment~     groups are compared to one placebo group.~   "
90304|NCT01875484|"~     Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left~     ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous~     coronary intervention for ST-segment elevation myocardial infarction.~   "
90305|NCT01875471|"~     The objective of this study is to compare the ease of removing two daily disposable soft~     contact lenses off the eye.~   "
90273|NCT01875705|"~     This is an open-label, multicenter, dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or~     metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation~     stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the~     safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered~     daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of~     the recommended dose of GDC-0994 determined in Stage I.~   "
90274|NCT01875692|"~     Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The~     hypothesis of the investigators is that during the first days of intubation, independently~     of the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the~     selection of one pathogen in the trachea, that will finally be the cause of VAP.~      The investigators designed a prospective study including 300 patients intubated for more~     than 3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture~     and metagenomics, in order to determine if this microbiological surveillance permits:~        1. To predict a high risk to develop a VAP in the next 48h and even to predict its agent~        2. To better understand the development of VAP by studying the evolution of the~          respiratory flora in the context of intubation~   "
90275|NCT01875679|"~     Simulation in surgical skills training is widely accepted as a necessary step to improve~     surgical training outside the operating room. Simulation predominately focuses on teaching a~     specific task or procedure. Once this task is acquired ongoing optimization of technique is~     desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout~     training rotations. This feedback is frequently subjective and of variable educational use.~     Identifying ongoing technical training needs and enabling personalized objective feedback~     represents an important training concept that has not yet been formally used in resident~     training.~      The specific goal of this study is to prove the effect of a comprehensive surgical coaching~     (CSC) approach which combines concepts of behavior modeling training, task debriefing and~     error recognition to improve overall surgical technique without additional technical skills~     training.~   "
90276|NCT01875666|"~     Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind~     of kinase. This study looks at a new approach to identifying kinases, which may help target~     therapy more precisely.~      LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore~     the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to~     undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of~     oligometastatic disease). Patients will initiate dosing with either a single HER2-directed~     agent or a combination of two HER2-directed agents, one week prior to surgery. Forty~     patients will be randomized to one of four study groups:~      A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose~     trastuzumab plus single dose pertuzumab; or D) combination single dose trastuzumab plus~     lapatinib daily for 7 days.~      Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures.~     The initiation of study drug will be defined by the surgical schedule; there will be no~     delays in standard treatment for the purposes of this study.~   "
90277|NCT01875653|"~     The purpose of this research is to evaluate the safety and effectiveness of tumor cell~     therapy.~      This research study is evaluating if a patient-specific experimental therapy for metastatic~     melanoma will lengthen survival with minimal harmful effects. It is called an experimental~     therapy (or study therapy) because it is not yet approved by the U.S. Food and Drug~     Administration (FDA). This research study will use the patient's own tumor cells,the~     patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony~     stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that~     stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a~     standard treatment to help increase the number of white blood cells after chemotherapy.~      The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and~     the growth factor. The resulting solution is called the study therapy. The intent of the~     study therapy is to make the dendritic cells more effective at fighting the tumor when they~     are injected back into the patient.~   "
90278|NCT01875640|"~     The birth of a child with a disorder of sex development (DSD) is stressful for parents and~     members of the healthcare team. The right decisions about gender assignment (is it a boy?~     a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are~     not obvious. While there have been large advances in diagnostic assessments like genetic and~     endocrine testing, the tests do not always show what caused the DSD. And, even when the~     tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally~     does not usually lead to a single correct treatment plan. Instead, it is likely that there~     are different acceptable treatment options - and parents will need to make decisions based,~     in part, on their personal preferences, values, and cultural background. Adding more stress~     to the situation is knowledge that many of the decisions that need to be made by parents~     early in a child's life are irreversible and exert life-long consequences for the child and~     the family.~      To support parents becoming actively involved in making such decisions, and to reduce the~     likelihood of future worry and regret about decisions that have been made, the investigators~     will create a decision support tool (DST). The DST will help educate families about typical~     and atypical sex development of the body, the process by which DSD are diagnosed (especially~     how to interpret genetic test results), and possible relationships between~     diagnostic/genetic testing, decisions about care, and known consequences of those decisions~     on their child and entire family. The DST will be used by parents of young children together~     with their child's health care provider.~      The investigators will bring together a network of researchers, health care providers,~     representatives of patient support and advocacy organizations, and parents of children with~     DSD to share their experiences. Participants of this network will be involved at each stage~     of creating the DST, revising it, and putting it into practice. At the end of this project,~     the investigators will have a fully formed and tested DST that will be available for parents~     to use with their child's health care team as they are first learning their child may have a~     DSD.~   "
90279|NCT01875627|"~     To evaluate the effects of Konjac on satiety and subsequent food intake in healthy~     individuals.~   "
90280|NCT01874769|"~     Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited~     skin disorders affecting children and adults. Current medical care protocols for RDEB~     patients are limited to palliative procedures to treat blistering and erosive lesions,~     wounds, and severe local and systemic complications such as fusion and contracture of the~     digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and~     growth retardation. However, current medical treatments still cannot prevent the recurrence~     of the lesions arising from defective expression of type VII collagen (COL7A1), the main~     constituent of anchoring fibrils which form essential structures for dermal-epidermal~     adherence.~      The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to~     repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa~     (RDEB).~   "
90281|NCT01874756|"~     The primary objectives of this application are to determine if the selective ERβ agonist~     LY500307, when added to antipsychotic medications, improves negative and/or cognitive~     symptoms in patients with schizophrenia. The specific hypotheses to be tested are to~     determine if LY500307 is safe and well tolerated in this population and whether it elicits a~     sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage~     Phase 1b/Phase 2a adaptive (drop the inferior dose) experimental design is ongoing that~     combines three studies (clinical dose optimization, cortical target engagement confirmation~     and efficacy and safety assessment) into a single clinical trial.~      Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of~     Stage 1 was to identify and advance the highest dose that did not demonstrate a safety~     signal and had target selectivity as determined by lack of TT suppression. This criteria was~     fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2.~     Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT~     decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150~     mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms:~     placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses~     for safety and target selectivity, confirm cortical target engagement and assess efficacy.~      Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed~     by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI~     episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked~     response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG~     (QEEG).~      Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the~     primary efficacy endpoints: negative symptoms (Negative Symptom Assessment Scale - 16-item~     total score), working memory (the composite score for the Letter Number Sequencing and~     Spatial Span tests) and verbal memory (Hopkins Verbal Learning Test).~      Primary Aim 3: To determine if LY500307 reduces total testosterone (TT) plasma~     concentrations, which is indicative of loss of selectivity for ERβ and engagement of ERα,~     using the following criteria: Decrease in TT plasma concentrations of 50% from baseline in~     50% of subjects per arm treated for two consecutive post-randomization values with LY500307~     in Stage 1 and Stage 2 of the trial.~      Primary Aim 4: To assess the safety of LY500307 by determining if there are SAEs, AEs~     probably related to study drug, QTc prolongation, TT suppression (50% reduction from~     baseline) and to evaluate for other safety signals.~      Secondary aims are to assess LY500307 effects on regional brain activation and connectivity~     during working (2-Back visual-verbal working memory task) and episodic (scene encoding and~     recognition)and memory tasks, and to evaluate electrophysiological indices of auditory~     sensory processing and working memory (auditory steady state responses, mismatch negativity~     (MMN) and auditory P300). It is predicted that LY500307 will produce greater increases than~     placebo in brain activity in prefrontal cortex and hippocampus during the working memory and~     episodic memory tasks, respectively, connectivity during resting fMRI, as well as increases~     in power of the auditory steady state response, MMN amplitude and P300 amplitude. The fMRI~     and electrophysiological measures will provide evidence of target engagement of LY500307 in~     schizophrenia and will be assessed as potential biomarkers for future clinical trials.~     Additional secondary aims will include assessing the effects of LY500307 on safety, positive~     symptoms, depression, social functioning and quality of life.~   "
90282|NCT01874743|"~     Participating countries: France Objectives Principal objective To evaluate, in HIV-1~     infected patients receiving effective antiretroviral therapy, the effect of the addition of~     Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the~     proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR~     Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4~     and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main~     serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To~     evaluate the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8~     T-cell ratio To study the relationship between the level of immune activation and the level~     of residual HIV replication in plasma To study the effect of Rosuvastatin administration on~     lipid profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio~     To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day~   "
90283|NCT01874730|"~     This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea.~     The study will be carried out as a prospective, randomized, controlled, multicenter,~     clinical trial in patients undergoing colorectal surgery. The purpose of this study is to~     determine if an enhanced recovery strategy paying close attention to the type and amount of~     fluid given during the surgery with proper monitoring combined with a comprehensive~     perioperative pain management will have a better post-operative outcome compared to~     institutional standard of care (SOC), in patients undergoing surgery of the colon. One of~     the fluids used, Volulyte®, is an intravenous solution used to treat low blood volume. The~     Volulyte® solution being used in the study and the monitor used are approved by the Korean~     Food and Drug Administration~   "
90284|NCT01874717|"~     Use lay language.~      To compare patient level of cooperation during dental care under conscious sedation with~     midazolam according to the administration route~   "
90285|NCT01874704|"~     A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical~     errors, and also increase coronary heart disease. Emergency physicians subjectively complain~     of stress related to changes in work shifts. Several potential biomarkers of stress have~     been described, but never investigated in emergency physician, who may represent a good~     model of stress due to the complex interplay between stress (life-and-death emergencies,~     which is the defining characteristic of their job), lack of sleep and fatigue due to~     repeated changes in shifts.The aim of this study was to compare biomarkers in emergency~     physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those~     working a control day (clerical work on return from leave). We also followed these markers~     three days following each shift (D3/24hS and D3/14hS).~   "
90286|NCT01874691|"~     This study is to build a Chinese national registry and surveillance system for acute~     myocardial infarction(AMI) to obtain real-world information about current status of~     characteristics, risk factors, diagnosis, treatment and outcomes of Chinese AMI patients;~     And to propose scientific precaution strategies aimed to prevent effectively from the~     incidence of AMI; And to optimize the management and outcomes of AMI patients through~     implementation of guideline recommendations in clinical practice, and analysis and~     development of effective treatment strategies; And to create cost-effective assessment~     system.~   "
90287|NCT01874678|"~     Objectives:~        1. Primary Objective:~           To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin~          in Taiwanese advanced NSCLC patients from that gained from Japanese population~        2. Secondary Objectives:~      A. To assess progression free survival B. To assess overall survival C. To bridge the safety~     profile by assessing the toxicities and tolerability~   "
90288|NCT01874665|"~     The purpose of this study is to evaluate the efficacy and safety of ponatinib in patients~     with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure~     of prior tyrosine kinase inhibitor (TKI) therapy.~   "
90289|NCT01874652|"~     The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast~     Implant (LWBI) in breast augmentation.~   "
90290|NCT01874639|"~     Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the~     most effective possible tool for hemostasis allows a bleeding decrease during liver~     transection and thus could reduce postoperative morbidity.~      In the past decade, the improvement of techniques of transection of the hepatic parenchyma~     was one of the most important factors to ensure the hepatectomy safety. But the clinical~     performances of these technological innovations (ultrasound dissectors, monopolar~     radiofrequency probes and dissection devices using pressurized water) remain still unclear.~      The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology~     of transcollation combining a source of radiofrequency associated with a conductive liquid~     (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump~     Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of~     radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device~     consists in maintaining the tissue to a temperature of 100°C, while using a conductive~     liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks~     of electric arc and overheating met with conventional electrosurgery. This device allows the~     coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the~     postoperative morbidity and mortality due to a decrease of blood loss and biliary leak.~     These clinical benefits could be translated by an improvement of the direct and indirect~     costs associated to the surgery. However the Aquamantys® technology has not been~     scientifically validated in the context of the hepatic surgery, and this technology is~     expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®)~     and to the investment in a generator (Aquamantys Pump Generator®).~      Consequently, it is essential to realize a study measuring the clinical and medical economic~     impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.~   "
90291|NCT01874626|"~     This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose,~     parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older~     with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all~     eligibility criteria, will be randomized into the study and will receive either the active~     treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount~     equivalent to a 4 inch line of investigational product to the affected ankle approximately~     every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of~     the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a~     24 hour period. Duration of treatment with the investigational product is 7 days.~   "
90292|NCT01874613|"~     Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone~     defects and orbital floor defects.~      Functional and aesthetic outcome is assessed by patient and doctor.~   "
90293|NCT01874600|"~     The seizure detection and warning system is an ambulatory system designed to monitor and~     analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to~     alert caregivers that a seizure is occurring.~   "
90294|NCT01874587|"~     The Phase III study will include 174 patients with locally advanced oropharynx carcinoma,~     receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant~     systemic therapy. Two arc-IMRT treatment arms will be compared: one standard arm based on~     the use of a single pre-treatment planning and one experimental arm (adaptive RT) based on~     a weekly replanning to spare the salivary glands. The main objective is to increase by 25%~     the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing~     local control. The secondary objectives are to increase the salivary flow (scintigraphy),~     reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE),~     while maintaining local control (stopping rule of the trial if difference>15%). 174 patients~     will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human~     Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality~     Assurance) will be performed.~   "
90295|NCT01875601|"~     BACKGROUND:~        -  Despite progress, some children and young adults with solid tumors still experience~          poor survival.~        -  Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade~          procedures are available to generate large numbers of activated NK cells for adoptive~          cell therapy.~      OBJECTIVES:~        -  Primary objectives are: 1) to assess the feasibility of harvesting and expanding~          activated NK cells to meet escalating dose goals in Cohort A, 2) to assess the toxicity~          of infusing escalating doses of activated NK cells following lymphodepleting~          chemotherapy without rhIL15 (cohort A), and 3) to assess the toxicity of infusing NK~          activated cells with escalating doses of rhIL15 (cohort B) in pediatric patients with~          refractory malignant solid tumors.~        -  Secondary objectives are: 1) to identify biologically active doses of activated~          autologous NK cells plus or minus rhIL15 by monitoring changes in NK cell number,~          phenotype and function, 2) to assess pharmacokinetics and immunogenicity of rhIL15 in a~          pediatric population, and 3) assess antitumor effects and changes in FDG-PET following~          administration of activated NK cells to lymphopenic hosts plus or minus rhIL15. 4) to~          evaluate saftey and efficacy of subsequent cycles of autologous NK cell infusions in~          patients in cohort A who received benefit from the first NK cell infusion.~      ELIGIBILITY:~        -  Patients in Cohort A: 2-29 years with with refractory pediatric malignant solid tumors,~          Patients in Cohort B: 2-25 years with refractory pediatric malignant solid tumors.~        -  Adequate performance status and organ function, recovered from toxic effects of prior~          therapy, no requirement for systemic corticosteroids and no history of allogeneic stem~          cell transplantation.~      DESIGN:~        -  All patients receive pre-NK lymphodepleting chemotherapy with cyclophosphamide.~        -  Cohort A receives escalating doses of activated autologous NK cells to identify~          feasibility of generating cells and tolerability, and potentially identify an MTD.~        -  A1: 1x10(6) NK cells/kg~        -  A2: 1 x 10(7) NK cells/kg~        -  A3: 1 x 10(8) NK cells/kg~        -  If feasibility and acceptable toxicity is demonstrated for all doses in Cohort A,~          patients enrolled on cohort B will receive activated autologous NK cells plus~          escalating doses of rhIL15 using the following schema:~        -  B1: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10~        -  B2: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10~        -  B3: 1 x 10(7) NK cells/kg + rhIL15 0.5 mcg/kg/d IV x 10~        -  B4: 1 x 10(7) NK cells/kg + rhIL15 0.75 mcg/kg/d IV x 10~        -  Three patients will be enrolled at each dose level, with the dose level expanded to 6~          if dose-limiting toxicity occurs. An expanded group of 12 patients will be treated at~          the highest tolerable dose level. DLT toxicity monitoring will continue for 21 days~          after the NK infusion, or 14 days after the last rhIL15 dose in Cohort B (whichever is~          later).~   "
90296|NCT01875588|"~     Background:~      - People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory~     problems. These problems can vary widely, from few symptoms to severe problems with memory~     and concentration. It initially was thought that good HIV treatment could prevent almost all~     HIV-related memory problems. However, even people with low HIV viral loads can have these~     problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear~     why HIV causes these problems and why they may be worse in some people than others.~     Researchers want to study people with HIV and healthy volunteers to see how HIV may affect~     people with only small amounts of the virus in their blood.~      Objectives:~      - To study thinking and memory problems in individuals with HIV that is otherwise controlled~     with medications.~      Eligibility:~        -  Individuals between 18 and 61 years of age whose HIV has been controlled with~          medications for at least 1 year.~        -  Healthy volunteers between 18 and 61 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. A neurological test will also be given. Participants will~          have a baseline imaging study of the brain.~        -  Within 12 weeks of the first visit, participants will have a second visit. Additional~          blood samples will be drawn. Another brain imaging study will be performed.~        -  Within 8 weeks of the second visit, participants will have a third visit to collect~          more blood samples. They will also provide spinal fluid samples, either as a single~          visit or a longer procedure.~        -  After this visit, participants will return every 6 months for up to 5 years. Blood~          samples will be collected as needed at these visits. Thinking and memory tests and~          imaging studies may also be given as needed. Spinal fluid may be collected at one visit~          a year.~   "
90297|NCT01875575|"~     The objective of this study is to examine gastric emptying and satiety hormones after oral~     glucose stimulation in 2 different concentrations in normal-weight and obese patients.~   "
90298|NCT01875562|"~     Neck pain is a common symptom in most patients suffering from cervical radiculopathy.~     However, some conservative treatments are limited by their modest effectiveness. On the~     other hand, surgical intervention for cervical disc disorders is indicated when symptoms are~     refractory to conservative treatments and neurological symptoms are progressive. Many~     patients use complementary and alternative medicine, including Traditional Chinese Medicine,~     to address their symptoms. The purpose of the present study is to examine effectiveness and~     safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in~     patients with cervical radiculopathy.~   "
90299|NCT01875549|"~     Internal biliary drainage is an useful method for a control of jaundice and cholangitis to~     patients who had a malignant hilar obstruction due to hepatocellular carcinoma,~     cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.~      Bilateral biliary drainage is more physiologic but technically difficult to compared with~     unilateral biliary drainage specially related to conformability and flexibility between~     using stents.~      There are no prospective clinical trials compared with these internal biliary drainage~     methods in hilar malignant obstruction using metal stent.~      Therefore, the investigators want to compare the clinical outcome of two method: Unilateral~     biliary stent and Bilateral biliary stent~   "
90300|NCT01875536|"~     Given previous evidence that non invasive brain stimulation enhances the effects of~     conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed~     to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with~     conventional physical therapy (VRT) would be superior to physical therapy in improving upper~     limb function and quality of life with chronic stroke individuals.~   "
90301|NCT01875523|"~     The study is designed to evaluate the pharmacokinetics, safety and tolerability,~     immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with~     severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.~   "
90302|NCT01875510|"~     Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and~     neonatal development. Infants born prematurely are at special risk for DHA insufficiency.~     The source of DHA after birth for preterm babies who are not fed full enterally, are mostly~     fat emulsions as the component of total parenteral nutrition solutions which usually do not~     contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered~     from the first day of life and during parenteral nutrition-prevents infants from cholestasis~     and retinopathy of prematurity.~   "
90303|NCT01875497|"~     There is evidence that intense physical activity has a potential effect on thrombotic events~     due to catecholamine release. The hormones leptin and adiponectin have been used as markers~     of cardiovascular risk, but they are few and contradictory studies that relate physical~     training intensity and duration of high plasma concentrations of these hormones. The use of~     antioxidants, such as proanthocyanidins present in grapes, may help in reducing the~     undesirable effects of intense training.~   "
90306|NCT01875458|"~     Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that~     normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These~     drugs are available for oral or intravenous dosing and are prescribed at daily, weekly,~     biweekly, or monthly intervals. Among the many thousands of individuals who currently take~     these medications, certain individuals experience atypical femur fractures preceded by~     prodromal pain, changes in cortical thickening of bone, or bisphosphonate related~     osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of~     the jaws for 8 weeks or more and requires surgical treatment.~      This study will attempt to identify genomic and rna biomarkers that may play a role in~     differential metabolism of bisphosphonates or indicate tendency toward the severe adverse~     events associated with these drugs.~   "
90307|NCT01875445|"~     The purpose of this study is to evaluate the safety and effectiveness of inositol for the~     treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for~     diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression,~     schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism,~     promoting hair growth, a skin disorder called psoriasis, and treating side effects of~     medical treatment with some medications, including lithium. The hypothesis to be tested is~     that Inositol will be effective and well tolerated in patients with trichotillomania~     compared to placebo. The proposed study will provide needed data on the treatment of the~     disabling disorder that currently lacks a clearly effective treatment.~   "
90308|NCT01875419|"~     Depression is a serious mental health problem that affects millions. Depression is usually~     treated using drugs and/or psychotherapy, but neither approach is successful for everyone,~     and some people do not respond to either. Therefore it is crucial that we continue to seek~     new methods for treating depression, and develop enhancements to existing treatments. In~     recent years, trials have documented improvements in depressive symptoms using noninvasive~     brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our~     aim in this research is to investigate the effects of brain stimulation combined with~     psychological therapy in depression, an area that remains largely unexplored. Specifically,~     stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work~     inefficiently in depression, has been shown to result in an improvement of depressive~     symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive~     control' processes, such as concentrating and ignoring distracting thoughts, are engaged~     during psychological therapies for depression, we predict that DLPFC stimulation should~     improve how patients respond to psychological therapy. This study has considerable~     implications as it will potentially benefit a large number of patients for which current~     treatments are ineffective.~   "
90309|NCT01875406|"~     The purpose of this study is to determine the predictive value of a composite of 3 simple,~     clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a~     pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal~     is to test these 3 tests and compare their predictive value to the 6 tests commonly reported~     in the literature in order to provide a clinician with clinically practical special tests to~     aide in the diagnosis and treatment of SIJ mediated pain. Specifically, the investigators~     seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's~     Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately~     predict the response (change in VAS) of a single diagnostic Sacroiliac joint and~     extra-capsular joint injection.~   "
90310|NCT01875393|"~     The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after~     TOOKAD® Soluble VTP in localized prostate cancer patients.~   "
90311|NCT01875380|"~     The purpose of this study is to assess the efficacy and safety of single-agent regorafenib~     in the first line treatment of frail and/or unfit for polychemotherapy patients with~     metastatic colorectal cancer (mCRC)~   "
90312|NCT01875367|"~     GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national~     designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of~     trastuzumab, and within the SC by the administration through the vial or device~     self-administration in patients with disseminated breast cancer HER2.~      Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose~     of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a~     syringe and 2 with the injection device). Following administration of these four cycles, the~     patient will decide whether or not to continue with the subcutaneous formulation of~     trastuzumab every 3 weeks until progression. Since the randomization in the study until the~     start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous~     trastuzumab as usual.~      Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs~     intravenous trastuzumab.~      This principal primary objective will be analyzed with the answers to questionnaire of~     experiences and preferences of the patients (Principal endpoint) The duration of the study~     has been estimated after 34 months.~   "
90313|NCT01875354|"~     The purpose of this study is to assess the safety and efficacy of a weight management~     program composed of dietary supplements and a reduced calorie eating program.~   "
90314|NCT01875341|"~     Hypertension is highly prevalent in type 2 diabetic patients (NIDDM) with nephropathy, and~     is the single most important determinant of the rate of renal function loss. In many of~     these patients, hypertension is resistant to therapy. Although increased sympathetic~     activity is also highly prevalent in NIDDM patients with nephropathy and chronic renal~     insufficiency, little attention has been paid to sleep apnea as the cause of both resistant~     hypertension and sympathetic hyperactivity in this population. Since the prevalence of sleep~     apnea is increased in patients with either NIDDM, or resistant hypertension, or chronic~     renal insufficiency, it is almost certain that sleep apnea has a high prevalence in patients~     in whom all three states co-exist, i.e. NIDDM patients with nephropathy and hypertension~     resistant to therapy. As a consequence of undetected and untreated sleep apnea, resistant~     hypertension, nocturnal hypertension, and sympathetic hyperactivity likely contribute to~     accelerated loss of renal function and increased cardiovascular morbidity and mortality in~     these patients.~      Hypothesis: A. Sleep apnea is highly prevalent in type 2 diabetic patients with diabetic~     nephropathy and hypertension resistant to therapy. Treatment with nasal continuous positive~     airway pressure (NCPAP) will result in a decrease in blood pressure and restore normal~     diurnal blood pressure pattern.~      B. Sleep apnea-caused hypertension is mediated by sympathetic hyperactivity and increased~     activity of the renin-angiotensin-aldosterone system (RAAS) in type 2 diabetic patients with~     nephropathy. A decrease in sympathetic hyperactivity in response to NCPAP therapy will~     result in a decrease in plasma renin activity and plasma aldosterone concomitant with~     decreases in blood pressure.~      Randomized, double blind, parallel comparative (two groups) one center trial.~      Therapeutic treatment with nasal continuous positive airway pressure (NCPAP) Sub-therapeutic~     treatment with nasal continuous positive airway pressure~   "
90326|NCT01875172|"~     The purpose of this study is to determine whether bupropion SR increases cessation and/or~     smoking reduction among pregnant smokers.~   "
90315|NCT01875328|"~     This study aims to determine whether patients who have had a stroke caused by a blockage of~     blood flow to the brain can have medical follow up after they leave the hospital in their~     home using a camera connected to a computer, also called telemedicine. Patients who have~     follow-up with telemedicine will be compared with patients following up in the usual way, by~     coming to clinic, and will have the same expectations for medical care and lifestyle changes~     like quitting smoking, exercising, and controlling their cholesterol. The study will try to~     show those stroke patients who live 75 miles or more from Oregon Health & Science University~     (OHSU) and use a computer for follow up: 1) Will be able to complete the recommended visits~     using telemedicine in the home as well as those who come to clinic; 2) Will have blood~     pressures controlled at one year's time as well as those who follow up in the usual way by~     coming into clinic; 3) The patients followed with telemedicine will be as satisfied with the~     type of follow up they had as those followed in the usual way in the clinic. In the future,~     more patients who live at a distance from a major hospital might be able to get quality~     stroke care follow up using telemedicine if the study finds that telemedicine does meet~     these goals.~   "
90316|NCT01875315|"~     The primary objective of this project is to demonstrate that a new approach to cardiac~     stress imaging that combines treadmill exercise with cardiac magnetic resonance (CMR)~     provides valuable clinical information in a cost-effective manner.~   "
90317|NCT01875302|"~     This protocol defines the requirements to demonstrate that the PRO instruments which were~     designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient~     reported outcome), following the ISPOR's ePRO Good Research Practices Task Force~     recommendations. All validation studies of the questionnaires were conducted using the~     original paper versions.~   "
90318|NCT01875289|"~     Efficacy of a modified obturator nerve block technique by using only a single morphological~     landmark, a double-blinded randomised pilot study.~   "
90319|NCT01875276|"~     The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to~     answer the following research questions~        1. What is the first prescription of the hay-fever season and how many of these patients~          are on some form of combination therapy?~        2. To what extent does initial therapy not meet clinical need (as measured by need for~          additional medical intervention in terms of consultations and changes in therapy)?~        3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs~          perennial patients?~   "
90320|NCT01875263|"~     Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related~     bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established~     clinical and microbiological criteria.~   "
90321|NCT01875250|"~     Background:~      - Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate~     cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible~     way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating~     therapy) that may help activate the immune system against the cancer. The immune stimulating~     vaccine will help white blood cells recognize and kill the cancer cells throughout the body.~     This vaccine therapy has been tested in hundreds of patients and is very well tolerated.~     Researchers want to see whether this vaccine, given with enzalutamide, is more effective at~     treating advanced prostate cancer than enzalutamide alone.~      Objectives:~      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy~     for advanced prostate cancer.~      Key Eligibility:~        -  Men at least 18 years of age who have advanced castration sensitive prostate cancer.~        -  Patients must have testosterone within the normal range~        -  No evidence of metastatic prostate cancer on CT or Bone scan~        -  No history of autoimmune diseases~        -  No previous immunotherpy within 3 years~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be used to monitor the cancer before~          treatment.~        -  Participants will be separated into two groups. One group will have enzalutamide and~          the study vaccine. The other group will have enzalutamide alone.~        -  All participants will take enzalutamide once a day. They will take the drug for 3~          months. This form of intermittent therapy is common in this population of patients.~        -  The vaccine group of participants will receive the new study vaccine. They will have a~          single injection on the first day of the first study cycle. There will be regular~          booster injections afterward. There will be one injection during the third week of~          treatment, and one in the fifth week. The vaccine will then be given every 4 weeks~          until 21 weeks have passed.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
90322|NCT01875237|"~     The goal of this clinical research study is to learn if giving genetically changed immune~     cells, called T-cells, after chemotherapy will improve the response to a stem cell~     transplant. The safety of this treatment will also be studied.~      The process of changing the DNA (the genetic material in cells) of these T-cells is called~     gene transfer. Researchers want to learn if these genetically-changed T-cells are~     effective in attacking cancer cells in patients with leukemia, MDS, lymphoma, Hodgkin~     disease, or MM, after they have received an allogeneic stem cell transplant.~      The chemotherapy you will be given on study is fludarabine, melphalan, and alemtuzumab.~     These drugs are designed to stop the growth of cancer cells, which may cause the cancer~     cells to die. This chemotherapy is also designed to block your body's ability to reject the~     donor's stem cells.~      Researchers also want to learn if giving AP1903 will help the symptoms of graft-versus-host~     disease (GvHD) that may occur after the T-cell infusion. GvHD occurs when donor cells attack~     the cells of the person receiving the stem cell transplant.~   "
90323|NCT01875224|"~     This study is being conducted to determine if belatacept is an appropriate alternative~     immunosuppressive medication (reducing the immune system's effect) when a kidney transplant~     patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed~     with NODAT will be approached with the opportunity to participate in this study. If they~     agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm~     (belatacept) or the control arm (their current medication regimen). If a patient is~     randomized to the study arm, they will be tapered off of their current regimen when they~     have started receiving their monthly belatacept infusions. The control arm will mean the~     patient will continue their current, standard of care medications, but following the~     tacrolimus trough levels indicated within the study protocol. Different laboratory tests~     (i.e. fasting blood glucose) will be measured during the study to monitor the progression of~     NODAT in all patients.~   "
90324|NCT01875198|"~     When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is~     usually performed not only for margin-negative resection but also for effective clearance of~     the splenic hilar lymph nodes. However, there was no scientific evidence regarding the~     justifiability for spleen resection. Considering potential immunological function of the~     spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for~     left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in~     terms of short-term perioperative outcomes and disease-specific overall survival.~   "
90325|NCT01875185|"~     The investigators are attempting to determine if the response to aspirin in women is related~     to the level of estrogen and progesterone that a woman has.~   "
90328|NCT01875146|"~     Investigation of the training effects following 8 weeks of high-intensity interval training~     (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT~     or side-alternating whole-body vibration. The adaptations are investigated on a molecular~     (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping~     mechanography, dynamometry) level. In addition, the acute effects of the first and last~     training session will be investigated on a molecular (e.g. satellite cell activation, mRNA~     abundance) and systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived~     exertion) level.~   "
90329|NCT01875133|"~     The purpose of this study is to investigate the effect of a stay at moderate altitude on~     exercise performance of patients with chronic obstructive lung disease.~   "
90330|NCT01875120|"~     This prospective observational study aims to evaluate the influence of somatic symptom load~     and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and~     vomiting (PONV). Physiological and psychological variables are assessed in female patients~     with an increased risk for PONV prior to a planned surgical intervention with a 33-item~     questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the~     occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized~     that patients with high sum scores for somatic symptom load (measured with the Patient~     Health Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured~     with the Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea~     and vomiting (PONV) than patients with low scores in both self-rating instruments.~   "
90331|NCT01875107|"~     Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on~     weight, given to pregnant patients with gestational or preexisting diabetes receiving~     betamethasone can provide adequate glycemic control.~      Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help~     maintain euglycemia for pregnant patients with gestational and preexisting diabetes after~     steroid administration, and possibly impact length of hospital admission.~   "
90332|NCT01875094|"~     This is a feasibility study of using health-IT to promote self-management of risk factors in~     stroke survivors.~   "
90333|NCT01875081|"~     If the participant voluntarily agrees to participate in the clinical trial before~     registration, the investigator conducts a screening test to evaluate the participant's~     suitability.~      A participant that satisfies all selection and exclusion criteria is assigned randomly to a~     test group (1-time or 2-time injection group) or control group (no-cell therapy group).~     Participants assigned to the 1-time injection group conduct cell therapy within 1 month~     after bone marrow aspiration. Before implementing cell therapy, implement hepatic artery~     catheterization which inserts a catheter into the hepatic artery through the right aorta~     femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells.~     Participants assigned to the 2-time injection group store 1-time injection amount of~     mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will~     re-inject autologous mesenchymal stem cells within 1 month after first injection.~      Participants will make a total of 8 hospital visits on a 4-week interval after registration,~     and effectiveness and safety will be evaluated based on a fixed procedure on every visit.~   "
90334|NCT01875068|"~     The investigators have previously demonstrated utilizing a validated tool, that the quality~     of referrals from nurse practitioners (NP) and physician assistants (PA) is less than~     referrals from physicians. The investigators hypothesize that with local physician input,~     the quality of referrals from nurse practitioners and physician assistants will improve.~     This is a prospective study comparing patient referrals from nurse practitioners and~     physician assistants with and without prior discussion with a local physician.~   "
90335|NCT01875055|"~     STUDY OBJECTIVES: The main objective of this study is to determine the feasibility of~     implementing measures in the ICU, based on a physiological algorithm, to reverse decreases~     in cerebral oxygen saturation using, near infrared-reflected spectroscopy (NIRS).~      WHAT IS INVOLVED: Randomization of 50 patients is balanced by experimental group; control~     and intervention, with an allocation sequence based on a block size of ten, generated with a~     computer random number generator. In the INTERVENTION group ICU Staff will use NIRS to~     follow a physiologically guided strategy to maintain rSO2 within 90% of baseline values. In~     the CONTROL group ICU Staff will provide standard of care without the use of NIRS.~   "
90336|NCT01875042|"~     The proposed study is a multi-center, randomized, double blind (patient and assessor), sham~     controlled clinical trial using a parallel 2 group design recruiting 220 patients of at~     least 18 years of age. The investigators will include patients presenting with clinically~     and radiologically diagnosed knee OA according to the criteria of the American College of~     Rheumatology, who experienced knee pain lasting for at least six months, and were diagnosed~     with radiographic severity of ≥ 2 on the Kellgren-Lawrence grading system or had one or more~     of the following signs and symptoms in the knee; restricted range of motion, pain in motion,~     crepitations, morning stiffness. Patients will be randomly allocated to receive TENS or sham~     TENS for 3 weeks.~   "
90337|NCT01875029|"~     Back School (BS) is a behavioural intervention designed to treat and prevent chronic low~     back pain. Up to date clinical research studies have shown that transcranial direct current~     stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the~     activity of brain areas involved in the circuits that regulate pain and facilitating the~     mechanisms inhibitors descendants of pain control.~      The aim of this study is to test the feasibility of combining tDCS with a behavioural~     intervention (i.e. BS) in subjects with chronic low back pain.~   "
90338|NCT01875016|"~     The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the~     LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.~      The investigators hypothesize that the investigators will be able to reduce > 50% of the~     initial LVOT gradient. This will be considered as a successful procedure.~   "
90420|NCT01873716|"~     This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated~     carotid endarterectomy. The nine patients will receive an injection of Indocyanine green~     (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.~      Immediately following endarterectomy, the resected specimen will be immersed in normal~     saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be~     performed.~      The investigators hypothesize that compared to controls, ICG-injected patients will~     demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of~     plaque.~   "
90339|NCT01875003|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants~     with asthma whose disease remains uncontrolled despite daily treatment with inhaled~     corticosteroids (ICS) therapy and at least one second controller medication. Participants~     will be randomized in a 1:1:1 ratio to receive double-blind treatment with either~     lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks~     (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by~     an optional 52-week double-blind active-treatment extension. The anticipated time on study~     treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue~     prematurely or decide not to take part in the optional active-treatment extension will~     transition to the 20-week safety follow-up period.~   "
90340|NCT01874990|"~     Cardiovascular diseases are the principal cause of death in women in developed and~     developing countries and are importantly promoted by hypertension. Salt sensitivity of the~     blood pressure is considered as an important cardiovascular risk factor at any blood~     pressure level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also~     arises as a risk factor for cardiovascular and renal diseases.~      The major aim of this study is to examine the salt sensitivity of the ambulatory blood~     pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with~     women with no history of pregnancy-related hypertensive complications. We plan to recruit 20~     non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race-~     matched premenopausal women as controls. The study has a case control randomized design. The~     salt sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in~     24h ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by~     adding capsules of 6gr of NaCl/ day in the usual diet.~      The participants are identified as women discharged from the Maternity of University~     Hospital of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data~     will be carefully recovered from hospital records to identify severe preeclampsia (PE),~     based on International Society for the Study of Hypertension in Pregnancy criteria. These~     criteria are systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with~     severe proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease~     developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia~     was also defined as occurring before 34wk of gestation. Women with a history of~     hypertension, diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will~     be excluded. Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral~     contraceptives and hormonal replacement therapy. The protocol is approved by the University~     Hospital Ethical Committee and written informed consent will be obtained from each~     individual in accordance with the declaration of Helsinki. The study is conducted between~     2009 and 2012 at the University Hospitals of Geneva, Switzerland.~   "
90341|NCT01874977|"~     The major goal of this project is to conduct a randomized, controlled trial of the impact of~     a practical, low cost physical activity intervention on fatigue among persons with~     rheumatoid arthritis (RA). Fatigue has been identified as a major concern for individuals~     with RA, and is considered a core outcome measure for RA. Our recent study of the sources of~     fatigue identified physical inactivity as a primary predictor of fatigue. Studies have~     examined the impact of exercise interventions on RA outcomes, but most of these~     interventions have focused on pain or function as outcomes. The few exercise studies~     examining fatigue suggest that increasing physical activity reduces fatigue, but the~     interventions have been resource-intensive, requiring specially trained personnel to~     administer them, highly structured activities, and/or attendance at classes or a specified~     facility. Each of these components increases the cost and barriers to implementation of an~     intervention. Pedometers have been shown to be an effective means of increasing physical~     activity, and could form the basis of a simple means to increase physical activity.~      This project will test the effect of a simple pedometer-based intervention, with two~     incremental degrees of guidance, on increasing physical activity and decreasing fatigue.~     Three groups (n=40 in each) will be studied: a control group with an educational pamphlet~     only, a pedometer-only intervention group, and a pedometer group with step targets. Both~     intervention groups will keep step-count diaries. Groups will be followed over 20 weeks. We~     expect that (1) the pedometer-only intervention group will increase activity more than the~     education group, and the group with step-count targets will demonstrate even greater~     increases in activity; and (2) greater increases in activity will be associated with greater~     decreases in fatigue. Secondary outcome measures will include depressive symptoms,~     self-reported sleep quality, and body composition. Our overall goal is to demonstrate an~     effective, yet simple and low cost, physical activity intervention to decrease fatigue that~     could be broadly accessible and have the potential for wide implementation.~   "
90342|NCT01874964|"~     Methadone maintenance treatment (MMT) has been shown to be effective in reducing drug use,~     criminal activity and recidivism. Given this effectiveness, maintaining individuals who are~     enrolled in community MMT when committed to the Department of Corrections for short term~     incarceration would improve post release outcomes. However, this is rarely practiced in the~     United States. Current practice at the Rhode Island Department of Corrections is to detox~     inmates on methadone within 30 days of being incarcerated. More than 75% of these~     individuals are incarcerated for less than six months. The period immediately after release~     from incarceration is a particularly high-risk time for HIV and other problems including~     drug relapse and overdose.~      The investigators hypothesize that inmates who are incarcerated for 6 months or less will~     have better outcomes and cost the state less money if they are maintained on their methadone~     dose and relinked to their community clinic at release, than the current practice of~     detoxification.~   "
90343|NCT01874951|"~     The purpose of this pilot study is to determine if taking a low dose of naltrexone in~     addition to an antidepressant medication can help treat relapse or recurrence in people with~     Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved~     naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has~     not approved naltrexone to treat depression. The investigators hypothesize that patients~     with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic~     agent assigned to treatment with low dose naltrexone will demonstrate higher rates of~     response compared to those patients taking placebo.~   "
90344|NCT01874938|"~     The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants~     with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ)~     cancer.~   "
90345|NCT01874912|"~     Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white~     adipose tissue. In this cross-sectional study, the researches investigated whether serum~     irisin levels are decreased in patients with sarcopenia compared with control subjects with~     normal muscle mass, and assessed the association between serum irisin levels and various~     metabolic parameters.~   "
90346|NCT01874899|"~     The main purpose of this study is to establish the extent that chronic pain patients~     implanted with surgical, laminectomy-type, leads experience position-related variation in~     spinal cord stimulation therapy and to investigate the effects of manual versus automatic~     position-adaptive spinal cord stimulation on clinical outcome.~   "
90383|NCT01874223|"~     The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of~     life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure~     the severity of cough, breathlessness, and changes in cough and disease-related quality of~     life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have~     been used in other types of disease, but have not all been tested and validated in patients~     with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related~     QOL questionnaire scores will correlate with physiologic markers of IPF severity and~     worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are~     important to assess the benefit of investigational drugs under development to treat patients~     with IPF.~   "
90347|NCT01874886|"~     Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4~     million Americans reporting past month use in 2010 and 4.6 million meeting criteria for~     dependence, underscoring the public health importance of understanding the biological~     implications of use. How heavy cannabis use affects brain structure and cognitive~     performance in late life is unknown. The ongoing maturation in the adolescent brain,~     including the developmental circuitry underlying memory performance and executive control~     puts the adolescent brain at high risk for detrimental effects of heavy cannabis use. With~     the aging of the 'baby boomer' generation, many people who used cannabis heavily as~     adolescents are now entering their senior years when age-related cognitive decline may~     begin. Cannabis use doubled in less than a decade during the 1970's when 38% of those~     surveyed in the U.S. Survey on Drug Abuse reported using cannabis and 12% of those users~     reported using cannabis more than 20 times a month. Understanding how heavy, early cannabis~     use may affect neurobiological and cognitive outcomes is of high importance for this aging~     population, which is already at risk for memory and cognitive deficits in aging. Because~     cannabis use appears to have a primary effect within the hippocampus, the main structure for~     memory and the structure affected most by age-related memory impairments and pre-clinical~     Alzheimer's disease, we expect that the effects of chronic cannabis use may be greatest~     during aging. To our knowledge, no study has investigated the long-term effects of~     adolescent cannabis use on hippocampal morphology and cognitive performance in an aging~     population.~      Investigators will investigate hippocampal integrity and cognitive performance using~     high-resolution magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and~     neuropsychological testing in an aging population of subjects (55-70 years old) who used~     cannabis more than 20 times a month for at least a year during adolescence. Investigators~     will compare data collected from heavy cannabis users to subjects who did not use cannabis~     but are matched for age, gender, education, light tobacco and light alcohol use. Finally,~     because family history and genetic risk are known to accelerate hippocampal morphology and~     memory decline in aging, the investigators will investigate whether possession of the APOE~     ε4 variant in heavy cannabis users is synergistically related to thinner hippocampal cortex~     and white matter deficits.~   "
90348|NCT01874873|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for~     VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to~     explore ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.~   "
90349|NCT01874860|"~     The purpose of this study is to determine if using preventive treatments such as Doxycycline~     (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer~     will help to reduce the incidence and severity of the skin rash associated with Cetuximab~     (Erbitux®) when compared to receiving standard care for the treatment of skin rash.~   "
90350|NCT01874847|"~     PURPOSE: The long-term goal of this line of research is to develop rational, biologically~     based evidence for the treatment of post-concussion syndrome (PCS) in children. The~     objective of this application is to examine the effect of melatonin on the symptoms of PCS~     and its neurobiology using integrated neurodiagnostic techniques in children.~      OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches),~     cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant~     morbidity in the child and his/her family), and yet there are no evidence-based medical~     treatments available. This suggests an urgent need to develop novel treatment options to~     improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms~     of action, and neuroprotective effects. Recent research suggests that the explanations for~     persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal~     circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators~     have two specific aims:~        1. To determine if treatment with melatonin improves PCS in children following mild~          traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or~          10mg of oral melatonin for 28 days will result in a decrease in PCS symptoms as~          compared with placebo. Effects will be dose-dependent and may be independent of sleep~          effects. Methods: A randomized double blind, placebo controlled trial (RCT); Outcome~          measure is a PCS symptom questionnaire. A subsequent RCT will then be performed using~          the optimal melatonin dose at a second centre.~        2. To understand the neurophysiological mechanisms of paediatric PCS and assess any~          resultant effects of treatment with melatonin. Methods: A case-controlled study within~          the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the~          neurophysiological properties of paediatric mTBI before and after treatment; Treatment~          groups from the RCT will be compared with two control groups: i) normal controls and~          ii) asymptomatic mTBI children.~      SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for~     PCS and 2) will provide valuable information about the neurophysiological properties of the~     brain associated with PCS following mTBI in children and how these change with symptom~     resolution.~   "
90351|NCT01874834|"~     The US EPA Clean Air Multiyear research program is moving toward a multi-pollutant approach~     to the assessment of air pollution in response to recommendations by the NRC 2004 and the~     BOSC in 2005. Such an approach better reflects the complexity of real-world air pollution~     problems and parallels evolving scientific and regulatory considerations. Ozone (O3) and~     diesel exhaust (DE) generally are major and important components of ambient air pollution.~     This proposed study will address the agency's goals by investigating the cardiopulmonary~     health effects in healthy human subjects co-exposed to O3 and DE. The findings derived from~     these exposures will provide NCEA findings for risk assessments of O3 and DE, as well as the~     Office of Air and Radiation (includes OTAQ and OAQPS) with information relevant to possible~     modulation of PM-induced health effects and responses by a gaseous co-pollutant for~     potential standard setting. Additionally the findings will address the fundamental driving~     principle of the Clean Air Research strategy related to reduction of health due to air~     pollutant exposures.~   "
90352|NCT01874821|"~     The purpose of this study is to examine the efficacy of dynamic splinting in reducing~     contracture following diagnosis of adhesive capsulitis.~   "
90353|NCT01874808|"~     This research program will focus on gait initiation and postural control in Amyotrophic~     Lateral Sclerosis (ALS) patients, by comparing patients with vs without postural instability~     (but also in comparison to controls), by using a multidisciplinary approach which combines~     neurophysiological and neuroimaging analyses.~      After clinical evaluation, two groups of ALS patients, defined upon the feature of postural~     instability, and one group of healthy subjects (n=25 for each group of patients and 20 for~     healthy subjects) will be included in the study.~      The neurophysiological evaluation will be performed through a gait initiation assessment,~     which will alow us to collect biomechanical and electromyographical data, such as the~     braking index.~      The neuroradiological evaluation will include first an fMRI analysis, a study of specific~     circuits in networks will be performed which will provide the first description of neural~     network dynamics associated with the preparation and execution of movement in ALS patients.~      The investigators major research hypothesis is:~        -  By comparing patients with vs without postural instability, but also in comparison to~          controls, the investigators main research neurophysiological hypothesis is that~          patients with postural instability will display an impaired braking.~        -  This impaired braking could be partly explained by a dysfunction and/or lesion of the~          basal ganglia and brain stem structures, corresponding to the investigators main~          neuroradiological hypothesis.~   "
90354|NCT01874795|"~     This study will evaluate the applications of ganglionar electrical stimulation in patients~     with Chagas Disease and Ischemic Heart Failure patients.~   "
90421|NCT01873703|"~     The purpose of this randomized, double-blind, placebo-controlled study is to determine the~     safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and~     FDA approved treatment for Myelodysplastic Syndrome (MDS).~   "
90355|NCT01874782|"~     Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and~     prolonged fall in blood pressure when assuming an upright position, such as transitioning~     from lying to sitting or standing, a condition also known as orthostatic hypotension (OH).~     Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating~     symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness.~     Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI.~     Clinical observations suggest that OH can lead to neurological deterioration in individuals~     who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation~     in 43% of physical therapy treatment sessions in a study of individuals with acute SCI~     despite the use of current treatment options. OH is known to adversely affect health, delay~     rehabilitation and prolong hospitalization in the acute phase of management of individuals~     who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical~     SCI at our center in 2004.~      We plan to research the efficacy of a low-cost, non-invasive device known as transcranial~     electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous~     studies have shown that this device is safe to use in individuals with SCI, and has improved~     blood pressure control in non-SCI individuals.~      We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will~     elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress.~     TES-induced differences will be most pronounced in those individuals with sparing of spinal~     autonomic pathways~   "
90356|NCT01874574|"~     Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of~     osteoarthritic knee patients.~   "
90357|NCT01874561|"~     This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized~     study, to compare treatment with intravenous custirsen at 640 mg (highest intended~     therapeutic dose) with placebo. The purpose of this study is to assess the effect of~     custirsen treatment on cardiac conduction and repolarization (electrical activity of the~     heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity~     consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The~     moxifloxacin arm is un-blinded but the ECG readings are blinded.~   "
90358|NCT01874548|"~     The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and~     spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2)~     to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular~     catabolic degradation response to stress) in the metabolic alterations in cervical cancer.~   "
90359|NCT01874535|"~     To investigate the impact of initial treatment duration (4-week versus 8-week)of~     Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in~     patients with symptomatic erosive esophagitis~   "
90360|NCT01874522|"~     The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral~     solution containing equivalent amounts FTD and TPI.~   "
90361|NCT01874509|"~     Alcohol is one of the leading contributors to premature mortality and disability. Most~     people with alcohol problems will never seek treatment. There is a need to develop alternate~     ways to help problem drinkers outside of formal treatment settings.~      One promising strategy is Internet-based interventions for problem drinkers. The first~     randomized controlled trial found that the investigators could reduce alcohol consumption by~     about six drinks per week at a six-month follow-up using a minimal, personalized feedback~     Internet-based intervention. The investigators second randomized trial demonstrated that an~     extended Internet-based intervention that contained a range of cognitive-behavioural and~     relapse prevention tools could produce greater reductions in problem drinking compared to~     that provided by the same minimal intervention at a six-month follow-up. Building upon this~     research, the current project will assess whether this extended Internet-based intervention~     can have a sustained impact on problem drinking. Specifically, the major objective of this~     project is to conduct a randomized controlled trial comparing the impact of an extended~     Internet-based self-help intervention for problem drinkers to a minimal Internet-based~     intervention in the general population of problem drinkers over a two year period.~      Problem drinking participants will be recruited through media advertisements across Canada~     and will be randomly assigned to the minimal or extended Internet-based interventions.~     Six-month, twelve-month and two-year drinking outcomes will be compared between experimental~     conditions. It is predicted that participants receiving the extended Internet intervention~     will display sustained improved drinking outcomes compared to participants in the minimal~     Internet intervention condition. This programmatic line of research will advance the science~     of Internet-mediated intervention.~   "
90362|NCT01874496|"~     Slow release iron capsules have been designed based on the gastric delivery system. Iron~     absorption from those capsules administered with and without meals will be measured using~     stable iron isotopes.~   "
90363|NCT01874483|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004~     following multiple dose administration over 14 days.~   "
90364|NCT01874470|"~     The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal~     denervation in subjects with resistant hypertension by using Allegro renal denervation~     system~   "
90365|NCT01874457|"~     On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a~     mumps seroconversion much lower (71%) than the expected 95%, according to the package~     insert. This could indicate that a substantial proportion of children was not protected~     after MMR dose.~   "
90366|NCT01874444|"~     The purpose of this study is to determine whether rTMS are effective in the treatment of~     tinnitus~   "
90367|NCT01874431|"~     To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it is~     safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.~     These treatment doses will be compared to placebo.~   "
90368|NCT01874418|"~     The purpose of our study is to investigate CSF and blood biomarkers among the subjects with~     mild cognitive impairment (MCI) and Alzheimer's disease (AD) as well as normal controls.~   "
90369|NCT01874405|"~     Iron overload is a leading cause of morbidity and mortality in transfusion-dependent~     patients. Deferasirox is the most promising iron chelator agent in several clinical~     scenarios. The investigators propose a retrospective study (chart review) to evaluate~     comprehensive iron overload management in transfusion-dependent patients treated with~     deferasirox for up to 5-10 years in a real clinical practice setting.~   "
90370|NCT01874392|"~     This clinical trial is a feasibility study to assess the performance of an Artificial~     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with~     type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin~     (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed~     study is to explore the feasibility of using multiple insulin delivery routes in order to~     mimic the physiology of both first- and second-phase insulin secretion. The intent is to~     exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and~     utilize the conventional subcutaneous route for management of basal insulin and as~     second-phase meal-related insulin.~   "
90371|NCT01874379|"~     In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities~     in a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle,~     PhD or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to~     determine their effects on a specific group of pre- and post-operative patients, compared to~     no integrative medicine intervention - considered Standard of Care. A total of 225 patients~     undergoing surgical hip or knee replacement will participate; one third of the patient~     population will receive the 'M'-Technique touch intervention, one third will receive Tusek's~     Guided Imagery intervention delivered by headsets monitored by therapists from our Center~     for Complementary Medicine (CCM) and one third will comprise the control group, consisting~     of routine preoperative & postoperative care without integrated intervention.~      Patients will be asked to complete Pain and Anxiety scales at four different timepoints~     throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and~     Post Operatively Day 0, Day 1 & Day 2.~      Rationale: Patients are often at their most vulnerable just prior to surgery when their~     stress and anticipation are high and again immediately afterward when their energy is lower~     and their bodies are trying to accommodate after an invasive procedure. In addition, the~     patient and his or her family sense a lack of control and feel a rise in anxiety over the~     possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can~     increase complication rates and slow recovery times resulting in longer hospital stays.~   "
90372|NCT01874366|"~     -  Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and~          Pharmacodynamics of Single and Multiple Ascending Doses of P11187~        -  It will be conducted in three parts, as described below:~        -  Part I will be the Single Ascending Dose (SAD) study~        -  Part II will be the Multiple Ascending Dose (MAD) study~        -  Part III will be the food effect evaluation~   "
90373|NCT01874353|"~     Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has~     already improved by taking platinum based chemotherapy. The patients must also have a fault~     in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the~     cells of the body; if this protein doesn't work properly it can increase the chance of~     getting cancer. The aim of this study is to see whether patients taking olaparib tablets~     last longer until their cancer gets worse, compared to those taking the placebo tablet. The~     study is also looking to see if there is an overall improvement to how long the patients~     survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of~     their life whilst living with ovarian cancer.~   "
90374|NCT01874340|"~     To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing~     multiple sclerosis.~   "
90375|NCT01874327|"~     The study will evaluate the efficacy of a novel intervention implemented in a classroom~     setting aimed at improving joint attention and joint engagement skills with infants who are~     at risk of developing an Autism Spectrum Disorder.~   "
90376|NCT01874314|"~     This will be a single center, open label, crossover study to evaluate the safety and~     tolerability of multiple dose levels of SQ109.~   "
90377|NCT01874301|"~     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the~     major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of~     ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of~     life. One of the hallmarks of chronic constipation is slow progression of contents through~     the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools~     that are difficult to expel. Previous studies have shown that probiotics improve colonic~     transit times in constipated patients. In addition, several other studies, employing a range~     of different probiotic strains, have shown a significant increase in defaecation frequency~     and improvement in stool consistency. However, the clinical relevance of these results is~     uncertain, due to small sample sizes and limitations in study methodology. The current study~     is designed to compare changes in gut transit time and gastrointestinal symptoms following 4~     weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled~     manner, in adults with constipation.~   "
90378|NCT01874288|"~     An open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK),~     biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20~     (B-lymphocyte antigen CD20) positive Non-Hodgkin Lymphoma (NHL) that have failed standard~     rituximab-containing therapy. Following peripheral blood B cell depletion with rituximab (if~     needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection~     for three consecutive days every three weeks.~   "
90379|NCT01874275|"~     The primary objective of this investigation is to assess the effectiveness of transcutaneous~     electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne~     Muscular Dystrophy and reduce the impact of DMD upon the participants' quality of life.~      The primary outcome measures will include:~        1. increased muscle strength,~        2. increased range of joint motions and~        3. improved sleep parameters of ASI, N3 and REM.~   "
90380|NCT01874262|"~     The purpose of this study is to evaluate whether the mobile-phone based patient support has~     an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes~     that will have a positive impact on the cardiovascular risk factors.~   "
90381|NCT01874249|"~     The purpose of this randomized clinical trial is to evaluate the utility of noninvasive~     markers for the detection of advanced fibrosis in patients newly diagnosed with~     Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.~      The primary objective is to determine the effectiveness of noninvasive markers for detect of~     advanced fibrosis in patients with diagnosis of fatty liver disease.~      The secondary objectives are:~        -  To determine the increase in health care with the specialist (gastroenterologist or~          endocrinologist).~        -  To determine which noninvasive evaluation strategy favors any treatment of fatty liver~          disease.~   "
90382|NCT01874236|"~     The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint~     blocks.~   "
90406|NCT01873924|"~     This study aims to assess the natural history of Batten disease by obtaining information~     about the motor, behavioral, and functional capabilities of individuals with Batten disease~     (Neuronal Ceroid Lipofuscinosis). This study will also refine and validate the Unified~     Batten Disease Rating Scale (UBDRS) as a clinical rating instrument for Batten disease.~   "
90384|NCT01874210|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect~     findings suggest that chronic kidney disease influences the colonic microbial metabolism~     with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease.~     Therefore, this study aims to elucidate the influence of renal dysfunction on microbial~     metabolism and to test the hypothesis that chronic kidney disease patients carry a different~     fecal metabolite profile.~   "
90385|NCT01874197|"~     An investigator-initiated, prospective, consecutively enrolling, non-randomized single~     institution clinical evaluation of the safety and effectiveness of physician modification of~     a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) to~     preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic~     aneurysms.~      The primary objectives of this study are to determine whether physician modified branched~     endovascular grafts are a safe and effective method of treating patients with~     thoraco-abdominal aortic aneurysms.~   "
90386|NCT01874184|"~     This randomized clinical trial studies a group-based lifestyle intervention or usual care in~     measuring biomarker levels in participants at high risk for breast cancer. Studying the~     effects that changes to daily eating and exercise habits can have on the body's hormone~     levels and the body's ability to activate proteins may help doctors identify interventions~     for individuals at high risk for breast cancer.~   "
90387|NCT01874171|"~     Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the~     developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection.~     HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good~     prognosis following treatment. Subsequently, patients can live with the considerable side~     effects for several decades.~      Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated~     similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing~     platinum-based compounds) in head and neck cancer, but is potentially less toxic.~      Results of this trial will be used to determine the optimum treatment of this debilitating~     cancer, with the primary aim of decreasing toxicity and improving quality of life for~     HPV+OPSCC patients.~   "
90388|NCT01874158|"~     The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women~     weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is~     detectable post treatment and to examine potential confounders to clearance such as~     bacterial vaginosis.~   "
90389|NCT01874145|"~     This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and~     tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW)~     administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.~   "
90390|NCT01874132|"~     Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly~     population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are~     among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to~     levels of physical activity, and is lower in individuals who exercise and have higher~     functional fitness levels. Thus, the Centers for Disease Control and Prevention, the~     American College of Sports Medicine, and the American Heart Association have recommended~     20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or~     at least 3 days a week in the case of vigorous exercise.The same organizations also suggest~     the inclusion of resistance training in order to improve functional fitness. Therefore, the~     purpose of this study was to compare different exercise modalities in long-term changes of~     CVD risk factors and physical fitness among older adults.~   "
90391|NCT01874119|"~     The purpose of this study is to investigate the effectiveness of intravenous fosaprepitant~     therapy to reduce nausea and vomiting during the treatment of high dose interleukin-2 (HD~     IL-2) therapy for metastatic melanoma or metastatic renal cell carcinoma. Fosaprepitant is~     an intravenous (IV) medication that is FDA- approved for use in adults for the prevention of~     nausea and vomiting during chemotherapy. Fosaprepitant works by blocking the neurokinin-1~     receptor, which is a receptor in the brain that is known to cause nausea and vomiting. Past~     studies estimate that up to 70% of patients undergoing treatment with HD IL-2 will have~     nausea and/or vomiting. While fosaprepitant has been used in clinical practice to treat~     nausea and vomiting during HD IL-2, there have not been any studies done to see how well it~     works. All patients will receive treatment (IV fosaprepitant) during the study during either~     the first or second hospital admission for HD IL-2. On the admission that the subject is not~     receiving IV fosaprepitant, the subject will receive placebo (a medicine that looks like~     fosaprepitant, but is not active). The study is double-blinded, which means neither the~     subject, nor the study doctor will know to which group you have been assigned to that~     admission (IV fosaprepitant or placebo). This study design was chosen to limit the potential~     for bias, which means the trial was designed to try to ensure that unknown factors do not~     affect trial results. When patients start the study, patients will be randomly assigned to~     one of two groups: those who receive treatment (IV fosaprepitant) first and those who~     receive placebo first. During the first admission, subjects will be given the IV~     fosaprepitant or IV placebo during admission. During the second admission, subjects will~     'crossover' and receive the other treatment that they did not receive during the first~     admission. Improvement in nausea and vomiting will be assessed by counting the number of~     nausea and vomiting episodes, recording if the subject needs additional medication for~     nausea and vomiting, and by using patient questionnaires.~   "
90392|NCT01874106|"~     The purpose of this study is to evaluate the effect of especial diet therapy~     Anti-inflammatory Diet on inflammatory, oxidative stress, and nutritional markers in the~     context of protein-energy wasting syndrome(PEW) in hemodialysis patients.~   "
90393|NCT01874093|"~     The primary objective of the study is to assess the safety and effectiveness of SPG~     stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in~     the anterior circulation, who received IV-rtPA and Standard of Care.~   "
90394|NCT01874080|"~     The purpose of this study is to determine if tablets manufactured at different sites have~     the same bioavailability, that is yield similar blood levels/concentrations of the drugs and~     are handled by the body similarly~   "
90418|NCT01873742|"~     Feedback in psychotherapy involves clients monitoring therapy process and progress, and on a~     frequent basis clients register these data into online questionnaires. These data are then~     fed back to the therapist, hence informing about the process and progress in therapy. This~     information can be shared with the client, something that may enhance the client involvement~     in evaluating and planning of the therapy. The same data can be used for research purpose.~     This randomized controlled multicenter study within Norwegian couple and family contexts~     will explore the effects of feedback in natural settings, and it collaborates closely with a~     similar American study in Chicago/Evanston, Ill.~   "
90395|NCT01874067|"~     This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West~     England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory,~     rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand~     pain, swelling and stiffness. People find they help but there is little research testing~     this. Of the five small studies published: two found little or no benefit; one found similar~     effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if~     gloves work helps therapists and patients judge if they will help.~      This is a feasibility study to help us plan a future trial testing if arthritis gloves work~     for people with arthritis. We aim to find out: the rate we can recruit people to the study;~     if OTs can assess people's hands and provide gloves as agreed; how many people do we need to~     take part in a trial; what do people think (if any) is the gloves' most important effect and~     how long should we test them for? We will analyse the data to see what effect the gloves~     have.~      The study will last 12 months. People will get arthritis gloves as part of their usual care.~     The OTs have agreed a standard way of assessing and providing the gloves to ensure best~     practice across departments. The assessments include: difficulties using hands, pain and~     stiffness levels, and measuring hand and finger joint size and movement. People can take~     part if they: have one of the three types of arthritis; are willing to wear Isotoner~     three-quarter length gloves; can attend the usual 4 week review appointment for~     re-assessment; will allow us to use their anonymized hand assessments. We will also~     interview some people about their views of the assessment and their treatment. Each patient~     will be involved for 4-8 weeks.~   "
90396|NCT01874054|"~     The purpose of this study is to assess safety and efficacy of brentuximab vedotin in~     combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It~     is an open-label, 2-stage study designed to determine the recommended dose level of~     bendamustine in combination with brentuximab vedotin. The study will assess the safety~     profile of the combination treatment and determine what proportion of patients achieve a~     complete remission.~   "
90397|NCT01874041|"~     The objectives of this study were to investigate the effects of massage therapy and occlusal~     splint therapy in the electromyographic activity and mandibular range of motion (ROM) in~     individuals with temporomandibular disorder (TMD) and compare the results with those~     obtained in a group of individuals without this disorder. Twenty-eight volunteers with TMD~     were randomly distributed into two groups, massage therapy and occlusal splint. Both~     treatments lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to~     the control group. The Fonseca's anamnestic index was used to characterize TMD and allocate~     the volunteers to either the intervention groups or control group. The electromyographic~     activity and Mandibular ROM was evaluated before and after treatment using a digital~     caliper. Two-way analysis of variance with the Bonferroni test was used for inter and~     intragroup comparisons (level of significance was set to 5%). Cohen's d was used to~     calculate the effect size.~   "
90398|NCT01874028|"~     To evaluate the effects of a single dose of trientine in children ≥6 years and adult~     patients with Wilson's disease.~   "
90399|NCT01874015|"~     This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and~     feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in~     fistulizing Crohn's disease.~   "
90400|NCT01874002|"~     Patients with stenosis in one or more coronary artery are often treated with a percutaneous~     coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep~     the vessel open over time.~      The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the~     Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The~     drug coating is designed to prevent re-narrowing of the stent. The endothelial cell~     attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall~     cells.~      The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in~     routine clinical practice. In total 1000 patients will be registered and followed for five~     years.~   "
90401|NCT01873989|"~     This study is designed to develop an effective treatment intervention for chronic pain,~     symptomatic hypogonadism, and opioid addiction~   "
90402|NCT01873976|"~     Cardiomyopathy is a disease of the heart muscle. It is rare, but it can be serious.~     Cardiomyopathy in children can result in death, disability, heart transplantation or serious~     heart rhythm disorders. Natural substances in the blood called cardiac biomarkers can be~     measured in the laboratory and could be a less invasive way (compared to echocardiograms or~     MRIs) to detect heart dysfunction in children with cardiomyopathy. Little is known about how~     useful and valid cardiac biomarkers are in the diagnosis and determination of the symptoms~     in children with cardiomyopathy. The long-term goal of this project is to study how helpful~     measuring cardiac biomarkers in children with cardiomyopathy is to their doctors in managing~     the care of these patients as well as improving their overall health. Measures of these~     cardiac biomarkers could help doctors in determining how best to care for a child with~     cardiomyopathy, including when to consider heart transplantation as a treatment option.~   "
90403|NCT01873963|"~     Cardiomyopathy in children is a serious disease which can result in death, disability, heart~     transplantation or serious heart rhythm disorders. Doctors know little about the causes of~     cardiomyopathy but would like to learn more. In fact, up to 50-75% of cases in children have~     no known cause. For this reason, the purpose of this study is to identify genes that cause~     cardiomyopathy or that influence how people with cardiomyopathy do over time. These findings~     could improve disease prevention, surveillance, early management, and prognosis.~   "
90404|NCT01873950|"~     This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their~     effects on electrophysiological and other clinical parameters. The underlying purpose is to~     determine if depolarization and repolarization effects caused by drugs with differing ionic~     channel mechanisms can be distinguished from one another, and to gauge the sensitivity and~     specificity of novel signal analyses for detection of depolarization and repolarization~     changes. Secondarily, to evaluate the exposure response relationship and drug induced~     effects on the heart rate biomarker relationship.~   "
90405|NCT01873937|"~     Low intensity laser therapy (LILT) has been widely applied in pain relief in several~     clinical situations. With the advent of new LED-based (light emitting diode) light sources,~     the need of further clinical experiments aiming to compare the effectiveness between them is~     paramount.~   "
90407|NCT01873911|"~     Hypothesis #1: Factor analysis of the revised Sanfilippo Behavior Rating Scale (SBRS) will~     identify a group of externalizing behaviors and a group of Klüver-Bucy syndrome-like~     behaviors as two different factors that are at least partially independent.~      Hypothesis #2a: Children with MPS III will show more hyperlocomotion, fearlessness,~     asociality and noncompliance than children of similar cognitive ability with MPS I.~      Hypothesis #2b: These behaviors will become more frequent and/or intensify over time,~     consistent with the Cleary and Wraith (1993) model. Quantifying them will provide a more~     empirical framework for staging disease progression.~      Hypothesis #3: Brain volumetric analysis and diffusion-tensor imaging will reveal~     abnormalities of frontal and temporal lobe structures that will correlate with externalizing~     and Klüver-Bucy syndrome-like behaviors, respectively.~      Hypothesis #4. Loss of cognitive and language function as measures of neurologic decline~     will directly precede or co-vary with behavioral decline.~      The primary objective of this study is to identify the behavioral phenotype and its neural~     basis in MPS III (Sanfilippo syndrome). Is the behavioral phenotype similar to that of~     Klüver-Bucy syndrome, and is there evidence for amygdala abnormality? The secondary~     objective of this research study is to develop easily administered, sensitive and specific~     neurobehavioral and neuroimaging markers to characterize the behavioral phenotype(s) of MPS~     III; to track their progression; and to delineate their neural substrates. Such markers are~     critical for identifying the stage of disease for each patient, and to measure treatment~     outcome. Although we know that severe cognitive decline is one essential characteristic of~     MPS III, the other highly salient characteristic is a range of abnormal and disruptive~     behaviors that can include, but go well beyond, childhood noncompliance and oppositionality.~     These behaviors set Sanfilippo syndrome apart from the other MPS disorders. They cause major~     disruption in the child's familial, school, and community environments. Delineating these~     behavioral abnormalities will help in better understanding the neurological disease.~   "
90408|NCT01873885|"~     This study is an exploratory Phase 1 randomized, double-blind (Investigator and study~     subject and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose~     escalation study that will enroll up to approximately 32 subjects with stage 1 or 2~     essential hypertension.~   "
90409|NCT01873872|"~     We have designed this study to measure the effect of normal flora supplementation, using~     available probiotics, on the incidence of Clostridium difficile-associated diarrhea~      in a population of general inpatients who are receiving antibiotics.~   "
90410|NCT01873859|"~     The purpose of this study is to determine whether metformin causes lactic acidosis in~     diabetic patients with preserved kidney function, undergoing coronary angiography or~     angioplasty with new contrast media.~      In other words is it necessary to discontinue metformin before these procedures, even when~     Iodixanol is used as contrast media, which is isosmolar agent and much more safer than~     urografin which was the main agent in the previous studies that were the base of present~     guidelines?~   "
90411|NCT01873833|"~     This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate,~     and trastuzumab work in treating patients with human epidermal growth factor receptor 2~     (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine~     and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving capecitabine and~     cyclophosphamide daily may kill more tumor cells. Lapatinib ditosylate may stop the growth~     of tumor cells by blocking some of the enzymes needed for growth. Monoclonal antibodies,~     such as trastuzumab, can block tumor growth in different ways. Some block the ability of the~     tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and~     trastuzumab together may be an effective treatment for breast cancer.~   "
90412|NCT01873820|"~     The purpose of this study is to compare the tolerance of two forms of vitamin C in adults~     with sensitivity to acidic foods.~   "
90413|NCT01873807|"~     Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying~     condition with less-used drugs could overcome resistance,reduce tumor burden, and most~     importantly, spare enough time for slow-growing GVL effect following immune reconstitution~     to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011~     (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL,~     resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2~     conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16~     conditioning regimen was associated with high transplantation-related mortality (TRM), which~     might be attributed to excessive suppression on both bone marrow and immune.~     TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect~     with less cross-resistance and immune suppression and reducing TRM.~   "
90414|NCT01873794|"~     Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer~     treatment - can severely interfere with activities of daily living, and has even been~     reported to be a factor in patient requests for hastened death. CRF can represent a serious~     clinical problem years after all treatment has ended. There is currently no effective~     treatment for CRF. The purpose of this study is to investigate whether systematic exposure~     to light (from a commercially available Litebook) reduces CRF or other symptoms.~   "
90415|NCT01873781|"~     Age related cataracts are responsible for about 51 percent of blindness worldwide and~     according to the WHO affect about 20 million people, according to the WH . As cataract~     surgery is firstline treatment in the western world, there is a constant attempt to improve~     artificial intraocular lenes (IOL).~      As for this study, the investigators seek to compare four different IOL designs in in a~     psychophysiological setting, allowing to assess the impact of these IOLs on vision and~     psychological processing of visual information.~      As these IOLs also have downsides, such as reduced light intensity or image alterations, the~     subjective preference and overall impression shall be investigated. The healthy subjects~     look through a stable spectacle frame mounted onto a table, which enables the investigator~     to insert the different IOLs. This would allow subjective testing of IOLs before surgery.~   "
90416|NCT01873768|"~     Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss~     following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic~     acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee~     arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and~     EACA provide similar blood decreasing effects following TKA or whether one drug provides a~     superior effect over the other in reducing patients' blood loss.~   "
90417|NCT01873755|"~     This proposal will address the existent gaps in the literature by identifying barriers and~     facilitators to participation in physical activity in inner-city minority elementary~     schoolchildren with asthma, more that half of whom are also overweight; developing and~     refining a school-based intervention in partnership with the community to improve physical~     activity; and conducting a pilot randomized controlled trial of the intervention to~     determine feasibility and obtain preliminary data for a future large-scale trial.~   "
90422|NCT01873690|"~     The purpose of this research study is to test whether administering one dose of an~     antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding~     any urinary infections compared to not taking an antibiotic. This is an important topic to~     study because urinary tract infections are one of the most common complications after this~     procedure and there is no clear standard of care regarding the use of pre-procedure~     antibiotics. Our study results will benefit future patients either by decreasing the rate of~     infections or decreasing the use of unnecessary antibiotics.~   "
90423|NCT01873677|"~     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque~     psoriasis.~   "
90424|NCT01873664|"~     The purpose of this study is to examine the possibility of using jaw-tapping training as a~     self-exercise for developing memory and preventing dementia in elderly subjects with memory~     disturbances using functional magnetic resonance imaging (fMRI).~   "
90425|NCT01873651|"~     The aim of the study is to describe the results after > 10 years due to a prosthesis~     implant.~   "
90426|NCT01873638|"~     Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical~     techniques for the management of symptomatic gallstone disease and both techiques have shown~     to be feasible for day surgery. However, to our knowledge the long-term outcome between~     these approaches has not been compared in randomised trials as day surgery procedures.~   "
90427|NCT01873625|"~     Osteoarthritis of the knee is one of the most common causes of disability among elderly.~     Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such~     as knee osteoarthritis. As the disease progresses the cartilage become frustrated,~     surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in~     T2-weighted MRI as increase in signal density. Patients are treated initially by pain~     management. In patients who don't response to first line treatment invasive treatment like~     total knee replacement is done. The investigators designed this clinical study with the aim~     of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal~     stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.~   "
90428|NCT01873612|"~     The overall aim with this project is to investigate the effect of dexmedetomidine on control~     of breathing in healthy volunteers and to compare it with propofol at the same degree of~     sedation.~   "
90429|NCT01873599|"~     In this study the investigators plan to recruit 70 patients reporting high levels of stress~     to test the impact of Positive Affect Journaling. Patients randomized to use the online~     intervention will be asked to journal about one of seven topics, several days each week, for~     three months. The topics (e.g., What went well) are designed to help the individual focus~     on some positive aspect of their life or themselves over the past day. Each topic is based~     on prompts shown to be effective in studies of up to one week in duration. In the summer of~     2012, our research team pilot tested each prompt with 20 patients with high levels of~     anxiety, which led to important changes to the prompts, to increase their potential impact.~     The main aim is to understand the impact of Positive Affect Journaling on psychological~     distress, as measured by the National Health Interview Survey.~   "
90430|NCT01873586|"~     The objective of this study is to prospectively evaluate the performance of Integra's~     OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for~     instrumented posterolateral spine fusion, as compared to local autograft.~   "
90431|NCT01873573|"~     The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection~     at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the~     opening of their esophagus and decrease the need for repeat dilations.~   "
90432|NCT01873560|"~     Fractional flow reserve (FFR) is a physiologic index for the determination of~     ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even~     multiple anatomic imaging parameters have been widely used in clinical practice for the~     assessment of optimal stent procedure. Prognostic value between post-stent FFR (FFRpost)~     have been rarely evaluated in patient treated with DES. This multicentre, prospective~     registry was aimed to evaluate influence of physiologic parameters on the clinical outcome~     after DES implantation.~   "
90433|NCT01873547|"~     The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China.~     The methods to treat SCI patients in sequela stage update are poor. Though traditional~     rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to~     improve the neurological disorders of these patients, such as sensory disturbance,~     dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation~     and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is~     unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint~     stiffness. However, it can not repair the damaged nerve function. Studies show that~     mesenchymal stem cell transplantation can remarkably improve the neurological function of~     SCI in animals without any severe side effect.~      In this study, 300 patients will be divided into three groups and the investigators will use~     mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also~     follow up 100 patients who only receive rehabilitation and another 100 patients who accept~     neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare~     the efficacy of these two treatments.~   "
90434|NCT01873534|"~     The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10~     subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses,~     followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have~     stable Hgb levels will start the washout period of one to eight weeks. During the washout~     period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm~     their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a~     1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic~     overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day~     29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period,~     the trial subjects will be observed for an additional 28 days to allow safety and~     immunogenicity assessments.~   "
90882|NCT01867645|"~     Critical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical~     illness. Retrospective data suggest that early application of IgM-enriched intravenous~     immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to~     assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a~     prospective setting.~   "
90435|NCT01873521|"~     It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to~     pressure support to provide noninvasive ventilation to children will result in a decrease in~     the number of children with moderate to severe respiratory failure failing noninvasive~     ventilation and requiring endotracheal intubation. It is further hypothesized that~     noninvasive ventilation with NAVA compared to pressure support will result in a decrease in~     the length of mechanical ventilation, and the length of PICU and hospital stay.~   "
90436|NCT01873508|"~     This single-center, open label, randomized, 3-period cross-over study will compare 3~     modified-release formulations of RO4917523 in healthy volunteers. Subjects will be~     randomized to one of six sequences to receive single oral doses of RO4917523 slow, target~     and fast release modified release (MR) capsules along with a reference intravenous microdose~     with the target capsule. A washout period of at least 21 days will occur between treatments.~   "
90437|NCT01873495|"~     The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for~     consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first~     complete remission following induction with cytarabine and daunorubicin, and also to assess~     the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with~     acute AML in first complete remission following 3 consolidation courses with omacetaxine.~   "
90438|NCT01873482|"~     Pre-agricultural societies almost universally used healing ceremonies that involved~     reverence, rhythm and dance in the presence of a healer. It is believed that we are wired~     for such experiences and they foster an integrative mode of consciousness similar to that of~     mindfulness based stress reduction, which has been shown to have therapeutic effects in a~     variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has~     developed a healing ceremony based in sub-Saharan African traditions. The investigators plan~     is to have 25 subjects with a variety of clinical conditions participate in this ceremony.~     Subjects will then be asked to write a commentary about their experience and to participate~     in a focus group discussion. It is anticipated that the study will give us some idea of how~     promising this approach would be and what kinds of patients might benefit. Safety issues are~     minimal and include the possibility of injury (though the dancing is not strenuous) and~     psychological distress.~   "
90439|NCT01873469|"~     Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM).~     Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission~     tomography (PET), where in some patients also tumour manifestations can be detected that are~     not visible in MRI investigations.~      The aim of the study is to investigate the association of high [11C]MET tracer uptake before~     postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in~     patients with glioblastoma multiforme. Also site of recurrence will be correlated with the~     [11C]MET imaging before and early during radiochemotherapy. All imaging information will be~     included in treatment planning or treatment decisions.~      The study provides a basis for later radiation dose escalation trials on the base of~     [11C]MET imaging.~   "
90440|NCT01873456|"~     The hypothesis is that there is a profit potential by implementing a multifactorial~     nutritional intervention among frail elderly since this will result in an improved~     nutritional status, functional capacity and improved quality of life.~   "
90441|NCT01873443|"~     This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of~     the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and~     safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have~     completed the scheduled visits in Study CT-P10 1.1~   "
90442|NCT01873430|"~     The aim of this study is to investigate the sun protective effect of melatonin, when used as~     a cream applied before sun exposure.~      Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is~     proven that the amount of free radicals in the skin are increased by UV exposure.~     Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that~     melatonin can be protective against the UV induced release of free radicals by acting as a~     radical scavenger and thereby protect against UV-induced cellular damage.~   "
90443|NCT01873417|"~     The primary objective of this study is to evaluate the effect of symptomatic therapies on~     gastrointestinal (GI)-related events reported by participants with relapsing forms of~     multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical~     practice setting.~      The secondary objectives of this study are as follows:~        -  To evaluate GI-related events requiring symptomatic therapy and the role of those~          therapies over time in participants with relapsing forms of MS initiating therapy with~          DMF in the clinical practice setting.~        -  To evaluate GI-related events that lead to DMF discontinuation after the use of~          symptomatic therapy in participants with relapsing forms of MS initiating therapy with~          DMF in the clinical practice setting.~   "
90444|NCT01873404|"~     The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010~     (Neublastin) in improving pain in painful lumbar radiculopathy participants when~     administered 3 times per week for 1 week.~      The secondary objectives of this study in this study population are as follows: To explore~     the duration of the effect of BG00010 in improving pain; To explore the dose response curve~     on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum~     exposure to BG00010.~   "
90445|NCT01873391|"~     The objective of this study is to assess which factors influence the pain perceived during~     diagnostic anesthesia-free hysteroscopy.~   "
90446|NCT01873378|"~     The primary outcome of this study is to assess if the GnRHa administration before cold loop~     hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical~     procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic~     therapy in terms of distension liquid absorption and duration of the procedures.~   "
90447|NCT01873365|"~     The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic~     neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults~     greater than or equal to sixty years of age.~   "
90448|NCT01873352|"~     The objective of this trial is to determine the role of renal sympathetic denervation in the~     prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a~     catheter-based AF ablation procedure is planned. Patients will be randomized to either AF~     catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic~     denervation.~   "
90449|NCT01873339|"~     This study will determine the effect of single and repeat administration of darapladib, a~     novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2~     (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose~     of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate~     the inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.~   "
90450|NCT01873326|"~     The purpose of this study is to learn about the safety and effectiveness of two different~     drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT).~     One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The~     other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of~     care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure~     every patient and therefore newer treatments are needed.~   "
90451|NCT01873313|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee~     replacement surgery. The investigators plan to measure these levels by testing blood samples~     taken over a timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
90452|NCT01873300|"~     Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal~     sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal~     incisions (belly area cuts), by using an endoscope to create a small cut at the most inner~     layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of~     the esophagus. The investigators are studying whether subjects who undergo Endoscopic~     Esophageal Myotomy will have similar functional outcome, and at the same time less pain,~     scar formation and wound infection than with laparoscopic or open surgery.~   "
90453|NCT01873287|"~     Concussion, a mild traumatic injury common in children and adolescents, is a complex~     pathophysiological process affecting the brain. The lay press is inundated with reports of~     tragic consequences of concussion, and children are not immune.~      Persistent postconcussive symptoms (PCS) is defined as the persistence of somatic,~     cognitive, physical, psychological or behavioural changes lasting more than one month~     following injury. PCS significantly impacts children and their family's quality of life~     through school absenteeism, depressed mood and loss of activities.~      Validated, easy-to-use prognosticators do not exist for clinicians to identify children at~     highest risk for PCS. As a result,physicians cannot accurately inform children and parents~     whether they should expect longer symptoms, nor initiate pharmacotherapy or other management~     to reduce the occurrence or severity of PCS.~      The investigators objective is to derive and validate a clinical prediction rule for the~     development of PCS in children and adolescents presenting to the emergency department (ED)~     following acute head injury. The investigators have three aims: (1) determine PCS incidence~     at one-month follow-up in children aged 5-17 who sustain a concussion; (2) derive a rule to~     predict PCS from variables present in the history and physical examination; and, (3) assess~     the accuracy, reliability and acceptability of the prediction rule in a subsequent cohort.~     Using a prospective, multicentre study at nine large Canadian pediatric EDs, the~     investigators will recruit the largest prospective epidemiological cohort of children with~     concussions in the literature.~      This work will provide rigorous evidence to determine PCS incidence in children and its~     impact on quality of life. The results will enable clinicians to identify children at~     highest risk for PCS, optimize treatment and provide families with realistic anticipatory~     guidance. This study will also establish a strong and vital evidence base to advance~     concussion research.~   "
90454|NCT01873274|"~     The objective of this study is to investigate the absorption of menaquinone-7 from a~     nutrient-enriched dairy product compared to a general dairy product enriched with~     menaquinone-7 and a menaquinone-7-containing supplement.~   "
90455|NCT01873261|"~     This pilot study will be an observational no randomize study in which the NiNAVAped protocol~     will be applied solely to the NIV NAVA arm.~   "
90456|NCT01873248|"~     This is a prospective, Phase 1-2, single center study in a total of 100 subjects with~     Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of~     68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET~     imaging agent for NETs.~   "
90457|NCT01873235|"~     Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney~     disease (ADPKD) have opened up possibilities of new therapies to prevent disease~     progression. High quality clinical investigations in patients with ADPKD, however, pose~     significant challenges to investigators including limited access to patients with~     ADPKD,insufficient guidance by experienced investigators and lack of resources to conduct~     these studies.~      The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to~     establish an infrastructure that will assist investigators in designing and conducting~     highest quality clinical and translational research focused on a diverse group of patients~     with ADPKD.~      Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=200) with baseline~     clinical phenotyping performed at the General Clinical Research Unit of the University of~     Maryland School of Medicine.~      Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort~     including serum, plasma,urine and DNA.~      Objective 3: To develop a collaborative network of physicians and practices in the~     Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer~     patients for future studies and trials.~      Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.~   "
90458|NCT01873222|"~     This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to~     evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS)~     imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.~   "
90459|NCT01873196|"~     This research will test alternative methods of ensuring compliance with recommended~     preparation and targeting of supplementary foods for malnourished children under five years~     of age.~      The hypotheses that the proposed study intends to test are as follows:~        1. With appropriate behavior change communication (BCC) and social support, and with~          provision of CSB and FVO in the correct proportions, it is possible to get women to~          prepare CSB with oil in the recommended ratio of 100:30, and in quantities just~          sufficient for the target child.~        2. Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with~          appropriate messaging and with instructions to direct the food to children and to~          prepare the CSB with oil in the recommended ratio and feed as instructed will result in~          better compliance.~   "
90517|NCT01872442|"~     Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to~     the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of~     Peg-IFNα2a with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the~     investigators address the question of the efficacy and safety of dasatinib in combination~     with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic~     Myeloid Leukemia in Chronic phase.~   "
90460|NCT01873183|"~     In bariatric surgery functional and feasible non- or mini-invasive modalities for~     monitoring, and ideal/lean body weight estimates are addressed to meet up individual~     variability in hydration needs, and to avoid hyperhydration.~      The aim of the study is to evaluate need of perioperative hydration by comparing~     conventional monitoring (the control group) to a more advanced approach (individualized~     goal-directed therapy, IGDT) (the intervention group). In addition to conventional~     cardiovascular monitoring (ECG, non-invasive blood pressure, Sp02) preoperative~     transthoracic echocardiography (TTE) and a intraoperative perioperative mini-invasive~     pulse-contour device (FloTrac™) will be used for the purpose.~   "
90461|NCT01873170|"~     This study is being done to understand if using birth control causes changes in the immune~     cells within the reproductive tract (including the cervix and the lining of the uterus) of~     healthy women. Immune cells are important because they help prevent infections from starting~     and help fight infections that have started. Immune cells are also the type of cells that~     HIV (human immunodeficiency virus) infects so understanding more about them will help to~     better understand how to prevent the spread of HIV.~      Immune cells will be studied from the reproductive tract of women who want to start using~     one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA),~     the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal~     implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women~     who are not using birth control and who are not at risk of pregnancy for comparison.~   "
90462|NCT01873157|"~     Late antibody-mediated rejection (AMR) after kidney transplantation is defined as a separate~     rejection entity. So far, no appropriate treatment has been established for this rejection~     type. One promising strategy could be the targeting of alloantibody-producing plasma cells.~     There is now accumulating evidence that the proteasome inhibitor Bortezomib may~     substantially affect the function and integrity of non-malignant alloantibody-secreting~     plasma cells. The impact of this compound on the course of late AMR , however, has not yet~     been systematically investigated. In the planned phase IIa study we will examine the effect~     of Bortezomib on late AMR after kidney transplantation. We plan an initial cross-sectional~     HLA antibody screening of 1000 kidney transplant recipients to identify patients with~     detectable donor-specific antibodies (DSA). DSA-positive recipients will be subjected to~     kidney allograft biopsy to detect morphological features consistent with AMR. Forty-four~     patients with late AMR will be included in a randomized double-blind placebo-controlled~     parallel-group intervention trial. Patients in the active group will receive two cycles of~     Bortezomib (4 x 1.3 mg/m2). The primary end point will be the course of estimated GFR over~     24 months after randomization. Secondary endpoints are the course of DSA levels and protein~     excretion, measured GFR after 24 months, transplant and patient survival, and the~     development of acute and chronic morphological lesions in 24-month protocol biopsies. Our~     study will clarify the impact of an innovative anti-humoral strategy on the deleterious~     effects of late AMR processes.~   "
90463|NCT01873144|"~     The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula~     (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute~     viral bronchiolitis in infants in improving respiratory distress and comfort and reducing~     length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).~   "
90464|NCT01873131|"~     The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate~     0.5% gel can help infants who have a hemangioma. The investigators also want to find out if~     pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too~     many side effects.~      Hemangioma is a common type of birthmark. These birthmarks happen when many new blood~     vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood~     through the body. No one knows what causes blood vessels to group together. Most birthmarks~     don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns~     have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually~     disappear within the first few months to years of life. These birthmarks tend to disappear~     spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's~     health, which occurs in about 1 in 3 children with hemagiomas.~      Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug~     Administration (FDA) for treating hemangioma.~      The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not~     approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas~     have received timolol maleate. The results so far show that timolol maleate may be helpful~     and safe in treating hemangiomas in infants.~      An important question being tested in this study is whether pulsed-dye laser or timolol~     maleate can prevent hemangioma from growing when used very early after birth.~   "
90465|NCT01873118|"~     Preparation of patients for discharge is a primary function of hospital-based nursing care~     and readiness for discharge is an important outcome of hospital care. Inadequacies in~     discharge preparation have been well-documented and linked to difficulty with~     self-management after hospital discharge and with increased likelihood of emergency~     department (ED) use and readmission. Prior studies by the research team have led to~     recommendations for implementation of discharge readiness assessment as a standard nursing~     practice for hospital discharge.~      The investigators will conduct a multi-site study to determine the impact on post-discharge~     utilization (readmission and ED visits) and costs of implementing discharge readiness~     assessment as a standard nursing practice for adult medical-surgical patients discharged to~     home. The study tests, in a stepped approach, the impact of implementing discharge readiness~     assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the~     incremental value of informing the nurse assessment with the patient's perspective~     (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents~     risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF~     protocol).~      HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital~     readmissions and ED visits within 30 days post-discharge compared to patients discharged~     under usual care conditions.~      HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer~     hospital readmissions and ED visits within 30 days post-discharge compared to patients~     discharged using the RN-RHDS protocol.~      HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a~     Nurse-Initiated Action Form [NIAF] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer~     post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS~     protocol; the effect will be strongest for patients with low RHDS scores.~      Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as~     standard practice, by comparing cost-savings from reduced post-discharge utilization against~     implementation costs.~   "
90490|NCT01872793|"~     Despite the importance of nutritional status in patient's outcome, there is no gold standard~     for nutritional assessment. Traditional techniques used in healthy subjects to assess~     nutritional status cannot be used in cirrhotic patients due especially to ascites and~     peripheral edema, and altered rates of biochemical markers due to liver failure.~      Bioelectrical impedance vector analysis has emerged as a useful method to assess body~     composition and nutritional status especially in patients at the extremes of body weight~     (fluid overload, excess of adipose tissue, etc.).~      With previous results from our research group, BIVA showed to be useful for evaluating~     cirrhotic patients.~      The aim of this study is to validate our previous results and validate BIVA for nutritional~     assessment in patients with liver cirrhosis~   "
90466|NCT01873105|"~     The purpose of this study is to improve the experience of discharge of adult medical~     surgical patients through improved discharge preparation communication between patients and~     care team members, with subsequent improvement in the post-discharge experience. Obtaining~     multiple perspectives on discharge readiness creates the opportunity for patient and care~     team to partner in identifying deficiencies in discharge readiness that warrant~     anticipatory, compensatory, or corrective interventions prior to discharge, with the goal of~     averting post-discharge problems and utilization. The results will also inform development~     and translation of tools for assessment of discharge readiness to clinical care~     environments.~      Specific Aims are to:~        1. Describe patterns of communication about discharge and collaboration among members of~          the health care team~        2. Conduct psychometric testing of 3 forms of the Readiness for Hospital Discharge Scale~          (RHDS - MD, RN, Patient)~        3. Describe relationships between care team communication, patient perceptions of quality~          of discharge preparation and perceived readiness for discharge, care team (RN and MD)~          assessments of discharge readiness, and post-discharge outcome ( post-discharge coping~          difficulty, Emergency Department (ED) use, and 30 day readmission.~        4. Determine the impact of an intervention with the inpatient care team to improve~          discharge preparation communication.~      H1: Patient perceptions of discharge readiness, post-discharge coping difficulty, ED use and~     readmission will improve following a care team educational intervention about discharge~     preparation, compared to pre-intervention baseline measures.~      H2: Care team members will report improved frequency and amount of discharge preparation~     communication following a care team educational intervention about discharge preparation,~     compared to pre-intervention baseline measures.~      H3: RN-MD collaboration will increase following a care team educational intervention about~     discharge preparation, compared to pre-intervention baseline measures~   "
90467|NCT01873092|"~     Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is~     progressive over many years and is largely irreversible. Advanced COPD is associated with~     arterial oxygen desaturation leading to a series of complications and, ultimately, decreased~     survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the~     exact target of oxygen saturation that actually translates into improvements is not known.~     The basis for the work in this proposal is to focus a new approach to measure oxygen~     desaturation linked to daily activity. Accelerometers are used to measure daily activity and~     then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation~     profile for individual patients. The three main objectives of this study are 1) determine~     the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in~     patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and~     reproducible; and 3) determine thresholds of oxygen desaturation that are associated with~     different activity profiles~   "
90468|NCT01873079|"~     Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and~     therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the~     important complications related to sphincterotomy. This study determines the role of proton~     pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP~     and sphincterotomy.~   "
90469|NCT01873066|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring~     lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections~     or the continuous insulin delivery using an insulin pump in order to keep blood glucose~     levels normal. We know that keeping blood sugars in the normal range will help prevent~     long-term diabetes-related complications involving the eyes, kidneys and heart. However,~     achieving treatment goals can be very difficult particularly due to the risk of low glucose~     levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected~     closely matches the blood sugar levels on a continuous basis. This can be achieved by what~     is known as a closed-loop system where a small glucose sensor placed under the skin~     communicates with a computer containing an algorithm that drives a subcutaneous insulin~     pump. We have been testing such a system in Cambridge over the last five years in children~     and have found that this system is effective, and superior to usual insulin pump therapy, at~     maintaining tight glucose control. More recently the system has been tested overnight, in~     the home setting, for three weeks in adolescents during a pilot single-centre study.~      The next step is to evaluate use of the closed loop system day and night over a period of 7~     days (phase 1) and 21 days (phase 2) in adolescents with type 1 diabetes. In the present~     study we are planning to study 24 (12 phase 1 ans 12 phase 2) young people aged 10-18 years~     on insulin pump therapy. This study will involve two 7 (phase 1) and 21 (phase 2) day home~     study periods, during which glucose levels will be controlled either by an automated~     closed-loop system or by subjects usual insulin pump therapy combined with continuous~     glucose monitoring alone in random order. Prior to the closed-loop study period, there will~     be a training period in the clinical research facility, which will allow participants to~     familiarise themselves with the closed-loop system before going home.~      We aim to to determine the effect of the closed-loop computer algorithm in keeping glucose~     levels between 3.9 and 10.0 mmol/L during the daytime and overnight.~   "
90470|NCT01873053|"~     This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase~     II clinical trial and aimed at osteoarthritis of the knee.~      Patients who signed informed consent voluntarily and eligible for this study are assigned~     randomly to one of 3 groups after 2 week-Washout period.~        1. st group (experimental) : WIN-34B 450mg BID~        2. nd group (experimental) : WIN-34B 900mg BID~        3. rd group (Comparator) : Placebo BID~      Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4~     weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination,~     questionnaire, laboratory experiment.~      After 8 weeks(Visit 4), researchers check adverse effects and current medication status via~     telephone interview.~      After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers~     check patients' physical examination, questionnaire, adverse effects and current medication~     status.~   "
90471|NCT01873040|"~     This study will assess the effectiveness of social media website devoted to vaccines to~     change immunization knowledge, perceptions and behavior. If effective, this intervention~     will represent an innovative, low cost and broadly applicable resource to reduce parental~     vaccination concerns.~      The study has two hypothesis:~        1. Parents receiving usual care plus social media website will demonstrate higher early~          childhood immunization rates to parents receiving either usual plus non interactive~          website or usual care only.~        2. Parents receiving usual care plus social media website will demonstrate positive~          changes in knowledge, attitudes and beliefs supporting vaccination compared to parents~          receiving either usual care plus non-interactive website or usual care only.~   "
90472|NCT01873027|"~     The aim of this randomized study is to evaluate the impact of Optical frequency domain~     imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent~     (DES) as compared with Intravascular ultrasound (IVUS) guidance.~   "
90473|NCT01873014|"~     safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine~   "
90474|NCT01873001|"~     The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics~     (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone~     acetate in healthy adult male participants.~   "
90491|NCT01872780|"~     The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in~     multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were~     evaluated.~   "
90525|NCT01872338|"~     The purpose of this study is to test a psychotherapeutic intervention that integrates~     cognitive therapy and mindfulness meditation techniques to prevent suicide in military~     Veterans.~   "
91612|NCT01858064|"~     The primary aim of this study is to assess the predictability of treatment response to~     stimulants in adults with ADHD using functional magnetic resonance~      This study will be a six-week, open-label study including adults ranging from age 18-55 with~     ADHD.~   "
90475|NCT01872988|"~     Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and~     chronic hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia.~     Transarterial chemoembolization (TACE) is the standard treatment for patients with~     unresectable HCC in the BCLC intermediate stage, but the HCC recurrence rates and long-term~     mortality rates are quite high. These intermediate-staged HCC patients usually need repeated~     TACE due to tumor recurrence, and they may die of HCC progression or liver decompensation~     after repeated TACE. Improved liver function and decreased liver disease progression due to~     oral antiviral therapy have been proven to be effective for chronic hepatitis B, and oral~     antiviral therapy may keep better liver reserve and provide better chance for HCC patients~     received TACE. In addition, chronic HBV infection is one of the most important factors for~     HCC development, and antiviral therapy can improve the outcomes after curative treatment.~     However, the evidence of improving outcomes of HCC patients underwent TACE by oral antiviral~     therapy is lacking. Moreover, Tenofovir Disoproxil Fumarate (TDF) is one of the most potent~     oral antiviral agents, and its safety and very low long-term viral resistance rate have been~     also reported. There is no study to evaluate the impacts of TDF for HBV-related HCC patients~     underwent TACE. Until now, routine antiviral therapy for HBV-related HCC patients underwent~     TACE has still not been recommended by current guidelines. The hypothesis of this study is~     that a potent oral antiviral therapy for patients with HBV-related HCC patients receiving~     TACE improve patients' outcomes~   "
90476|NCT01872975|"~     This randomized phase III trial studies standard or comprehensive radiation therapy in~     treating patients with early-stage breast cancer who have undergone surgery. Radiation~     therapy uses high-energy x rays to kill tumor cells. It is not yet known whether~     comprehensive radiation therapy is more effective than standard radiation therapy in~     treating patients with breast cancer~   "
90477|NCT01872962|"~     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus~     concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced~     nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in~     NPC patients.~   "
90478|NCT01872949|"~     The study is designed to observe the clinical outcomes of heart failure patients treated~     with C-Pulse® System in the usual manner and according to the approved indications and~     contraindications.~   "
90479|NCT01872936|"~     The purpose of this open-label study is to assess the safety, tolerability, antiviral~     activity, genotype resistance associated with virological failure, pharmacokinetics and~     pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and~     ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to~     pegylated-interferon alpha and ribavirin.~   "
90480|NCT01872923|"~     The primary goal of this extension study is to further investigate the tolerability and~     efficacy in a phase I setting in order to see whether lower doses than the initial study~     dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or~     improved safety and tolerability profile in combination with comparable signs of efficacy.~   "
90481|NCT01872910|"~     The main purpose of this study is to test if a single dose of LY3023703 relieves pain after~     wisdom teeth removal. The study will last about one week for each participant, not including~     screening.~   "
90482|NCT01872897|"~     This study is being conducted to assess the effectiveness of the Compound Sodium Alginate~     Double Action Chewable Tablets compared to placebo on acidic reflux events into the~     esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).~   "
90483|NCT01872884|"~     The purpose of this study is to evaluate whether general anesthesia or sedation technique is~     preferable during embolectomy for stroke, measured in terms of three months neurological~     impairment. In addition we study if there is any difference between the methods regarding~     complication frequency.~   "
90484|NCT01872871|"~     Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants.~     Although, local anesthetics reduce pain to some extent, eye examination still remains as a~     painful procedure. The investigators aimed to evaluate the effect of oral paracetamol~     combined with local anesthetics for pain relief during ophthalmological examination.~   "
90485|NCT01872858|"~     Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed~     cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive~     function, MRI and other sides at given time. The investigators hypothesize that cilostazol~     is more efficient and safer than aspirin in patients with VCIND.~   "
90486|NCT01872845|"~     Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL)~     cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery~     disease. However, there is lack of solid evidence whether a specific kind of statin have the~     superiority against other statins in clinical outcomes. Furthermore, recent data have showed~     that several kinds of statin could have an adverse effect on glucose metabolism and increase~     the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate~     marker of atherosclerosis to predict long term cardiovascular outcomes in not only general~     population but also patients with established coronary artery disease. Consequently, we will~     evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of~     rosuvastatin in patients with established coronary artery disease. Additionally, we will~     assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well~     as adverse outcomes including insulin resistance and new onset diabetes compared with~     rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to~     rosuvastatin 20mg regarding CIMT at 1 year follow up.~   "
90487|NCT01872832|"~     This study will explore the safety, tolerability, and serum uric acid lowering effect of~     RDEA3170 in healthy Japanese males to allow comparison with the Western population.~   "
90488|NCT01872819|"~     This clinical trial uses a laboratory test called a high throughput sensitivity assay in~     planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim~     is to try to identify drugs that may be effective in killing leukemia cells for those~     patients who will not be cured with conventional chemotherapy. This assay will test multiple~     drugs simultaneously against a patient's own donated blood sample. The goal is to use this~     laboratory assay to best match a drug to a patient's disease.~   "
90489|NCT01872806|"~     The main objective of this study is to investigate whether radiofrequency electromagnetic~     radiation, induced by a dialing mobile phone placed on the body, causes a change in~     electrophysiology.~   "
90492|NCT01872767|"~     After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will~     be made. These patients will undergo detail clinical, biochemical and microbiological~     examination at baseline. Clinical examination and Biochemical evaluation will be done daily~     and signs of infection will be noted. Patients will undergo microbiological screening for~     infection every 48 hours. Patients suspected or diagnosed to be suffering from infections~     will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy.~     Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at~     admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care~     Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive~     Care Unit).~   "
90493|NCT01872754|"~     The purpose of this study is to determine whether the use of Target-Controlled Infusion~     (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with~     spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of~     Propofol.~   "
90494|NCT01872741|"~     This randomized prospective study was designed to compare the clinical, functional and~     aesthetic results of two surgical techniques for microsurgical clipping of anterior~     circulation aneurysms~   "
90495|NCT01872728|"~     A bilateral facial block (infraorbital and infratrochlear) will be performed immediately~     after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine~     (intervention group) or saline as control. Intravenous saline or morphine will be~     administered at the end of surgery in intervention or control groups, respectively. In case~     of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups~     will receive intravenous morphine titration. The total perioperative morphine consumption~     (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain~     intensity, presence of nausea/vomiting and patient's satisfaction will be compared between~     groups.~   "
90496|NCT01872715|"~     The purpose of this study is to characterize rosacea patients', being treated with Oracea,~     perception through visual analog scale reporting.~   "
90497|NCT01872702|"~     The overall aim of this study is two fold:~        1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of~          artemisinin resistance in South East Asia.~        2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence~          and importance to on-going transmission of sub-clinical p.f malaria infections.~   "
90498|NCT01872689|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background~     IPF therapy or as combination therapy with pirfenidone background therapy in patients with~     idiopathic pulmonary fibrosis. Patients will be randomized to receive either lebrikizumab or~     placebo subcutaneously (SC) every 4 weeks.~   "
90499|NCT01872676|"~     The aim of the present study was to assess the immediate effects of upper thoracic~     manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii~     muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women~     of the university community were randomly allocated to an experimental group (n = 13) and a~     placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment~     T3)was performed. Infrared thermography was used to determine changes in skin surface~     temperature in the region of T3 and the biceps brachii muscle, which would indirectly~     reflect sympathetic activity. Images were taken prior to manipulation, immediately after and~     both five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc~     Bonferroni test and the independent samples t-test were used for the intragroup and~     intergroup comparisons, respectively, with the level of significance set to 5%.~   "
90500|NCT01872663|"~     The aim of this study will be to investigate the effects of using physical therapy resources~     in the postoperative morbidly obese individuals undergoing gastroplasty.~      It is believed that the application of these various features of physiotherapy after~     abdominal surgery may contribute differently in restoring lung function and prevention of~     pulmonary complications and can thus identify the resources that can contribute more~     effectively in post-operative bariatric surgery.~   "
90501|NCT01872650|"~     Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical~     leading to serious consequences and complications at reoperation.~      The investigators initiate a prospective, randomized, controlled, multicenter trial to~     assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in~     subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an~     adhesion prevention barrier for colorectal surgery will be compared with the control group~     at the second stage ostomy takedown procedure. The primary outcome evaluation will be~     assessment of adhesions to the incision site.~   "
90502|NCT01872637|"~     Hospitalization increases the risk for new disability in older adults. In the current health~     care system, home health physical therapy is understudied and often does not return older~     adults to prior levels of function. The proposed evidence-based multicomponent intervention~     that combines high intensity strength training and motor control based systems of gait and~     balance training will advance clinical practice by providing an intervention strategy for~     practitioners. If successful, improving patient function and decreasing re-hospitalization~     rates and falls will have large cost saving implications.~   "
90503|NCT01872624|"~     The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal~     cells in patients with severe pulmonary emphysema is safe and will contribute to increase~     quality of life.~   "
90504|NCT01872611|"~     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,~     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among~     diabetic participants following cataract surgery.~   "
90505|NCT01872598|"~     The objective is to compare the efficacy and safety of oral masitinib 3 or 4.5 mg/kg/day in~     combination with cholinesterase inhibitors and/or memantine to placebo in combination with~     cholinesterase inhibitors and/or memantine in patients with mild-to-moderate Alzheimer's~     disease.~   "
90506|NCT01872585|"~     The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting~     intervention for implementation with female adult caregivers who have or are at risk for~     long-term interpersonal conflict with family members, children, or significant others and~     are caring for a child between the ages of birth and 7 years.~   "
90507|NCT01872572|"~     This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of~     the safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an~     SC injection, with and without IV RB007 (an active control agent for RB006), in healthy~     young volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each~     (N=32); however, upon review cohort (Cohort 1-A) was necessary in order to fully define the~     PK profile of SC RB006. Therefore, 36 subjects were enrolled in this study.~      Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular~     cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in >1 dose group, and~     progression to the next higher dose only occurred if the prior dose level was well~     tolerated, as assessed by a Safety Review Committee (SRC)~   "
90508|NCT01872559|"~     The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic~     volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is~     currently in place. Those patients who are scheduled to have an ultrasound as part of their~     infertility treatment will be offered the opportunity to have additional measurements done~     at the time of their ultrasound; these additional measurements will take less than 2 minutes~     and do no require any additional sonograms, tests, or interventions. All patients are~     eligible (oocyte donors and autologous oocyte patients) and only patients with a serum~     estradiol > 2000pg/ML will be enrolled in the study. After the additional measurements are~     obtained, the results will be digitally stored. The results of the 3D sonographic volumetric~     analysis will then be correlated with the patients' IVF performance.~   "
90509|NCT01872546|"~     The expertise in the characterization of transcriptomics profile in lesional psoriatic skin~     and on the availability of innovative therapy for these patients.The investigators propose~     to follow the modification of the skin transcriptomics profile in psoriatic patients during~     successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic~     non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared.~     The investigators will focus on the modification of the cytokine signature in these skin~     lesions and of some markers of keratinocyte inflammation. The modification of the~     transcriptomics profile induced by the biotherapy will be correlated to the clinical~     response Psoriasis Area and Severity Index.~   "
90510|NCT01872533|"~     The purpose of this study is to look at how a reduction in oxygen levels (hypoxia)~     influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of~     exposure to moderate hypoxia (~ 15% O2, similar to conditions at an altitude of ~7500 feet)~     will improve glucose metabolism.~   "
90511|NCT01872520|"~     Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan~     (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of~     Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan~     in the real world, and observe the adverse drug reactions/ adverse drug events during~     treatment.~   "
90512|NCT01872507|"~     The effect of breathing biofeedback training to influence the function of the cardiac~     autonomic nervous system at rest and in activity in children with cerebral palsy.~      Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most~     common injury that causes physical handicapped in childhood. There are a few researches that~     investigated the autonomic function in cerebral palsy children. Those researches found~     hyperactivity of the sympathetic autonomic system, including high resting heart rate compare~     to their typically developed pears. The recommended treatment for cerebral palsy is~     activity, muscle strengthening and mobility. The impairment in the autonomic system~     influences the everyday function and has correlation with secondary morbidity.~      As far as we know there are no researches who investigated the following issues.~      In this study we would like to:~        1. Describe the autonomic cardiac function, Breathing function, motor function and the~          correlation between them in children with cerebral palsy.~        2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic~          breathing.~        3. Test the influence of breathing training on Heart rate variability parameters at rest,~          in aerobic test right after the breathing training program and one month after, in~          children with cerebral palsy~   "
90513|NCT01872494|"~     Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma~     and rich periosteum and joint capsule innervation, patients after general anesthesia~     immediately feel acute pain.The use of appropriate postoperative analgesia in patients with~     thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local~     anaesthetic via multilumen catheters that deliver directly to wound sites have been used for~     postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will~     make the mode of analgesia a better tolerated and more palatable option for patients. The~     aim of this study is to examine the effects of using local anaesthetic infusion catheters~     following posterior thoracolumbar surgery, and compares the outcomes of patients managed~     using intravenous analgesia pump infusion of systemic opioids.~   "
90514|NCT01872481|"~     Phantom Limb Pain (PLP) is a neuropathic chronic syndrome, characterized by a painful~     sensation in a body part that has been amputated. The incidence of phantom limb pain is~     between 50-80% of all amputees, however, additional risk factors as psychological trauma,~     blood loss, and infection increases its incidence after a traumatic amputation in landmine~     victims. Satisfactory management is often difficult to achieve and different clinical trials~     with medical and surgical measures have yielded unsatisfactory results. The response rate~     with pharmacologic treatment is around 30% using conventional medication as opiates and~     N-methyl-D-aspartate (NMDA) receptor antagonists, which is not significantly different from~     response rates with placebo.~      Recent case series have shown that repetitive Transcranial Magnetic Stimulation (rTMS) of~     the motor cortex can display an effectiveness that goes from 52% to 88% in the treatment of~     some refractory neurogenic pain cases which is quite superior to conventional management.~     However, the use of this type of treatment has not been studied in patients with phantom~     limb pain secondary to landmine injuries. The main objective of this trial is to evaluate~     the efficacy and safety of rTMS in the treatment of phantom limb pain in landmine victims.~      A double blind randomized placebo-controlled clinical trial, including 54 landmine victims~     with PLP will be performed. At the time of enrollment, a complete medical evaluation will be~     performed and those patients who meet the inclusion criteria will be randomly assigned to~     one of two groups, to receive rTMS in series of 20 trains of 6 s in duration (54-s~     intertrain interval) at a stimulation rate of 10 Hz (1200 pulses) and an intensity of 90%~     rest motor threshold using an active coil or a sham coil. Sessions will be administered~     5 days a week (Monday to Friday) during two consecutive weeks. The stimulation will be~     directed to the primary motor cortex contralateral to the amputated limb. Response will be~     evaluated by measuring the pain intensity at baseline and after each session using a visual~     analog scale. These measurements will be repeated 2 weeks after the end of the treatment~     scheme, in order to determine the duration of the analgesic effect of rTMS~   "
90546|NCT01872065|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     ARC-520 in normal, adult volunteers.~   "
90518|NCT01872429|"~     The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients~     with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this~     study to present the short- and long-term impact of PTX on calcium, phosphorus and intact~     parathyroid hormone control in dialysis patients with severe SHPT after operation. In~     particular, the investigators evaluate the impact based on the achievement of~     recommendations of the current clinical practice guidelines for bone and mineral parameters~     in dialysis patients after PTX.~   "
90519|NCT01872416|"~     At present, there is no standard second-line treatment of refractory and relapsed SCLC,~     topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide~     second-line treatment of small cell lung cancer currently being explored, Anthracycline~     antibiotics is a cell cycle non-specific anticancer drugs could inhibit the synthesis of~     DNA, DNA and dependent RNA, its wide antitumor spectrum, widely used in malignant~     hematologic diseases and lung cancer and other solid tumors. Jacot W, et al evaluated~     epirubicin combined with ifosfamide (EI) for treatment of refractory and recurrent SCLC in~     70 cases, the objective response rate (ORR) reached 21.4%, including 1 cases of complete~     remission, 10% other patients obtained stable disease (SD), all the patients had a median~     survival of 3.9 months, most (71%) patients with neutropenia, platelet count and anemia are~     also common, showed that EI treatment of refractory and relapsed SCLC is effectively~     controlled, toxicity.~      In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the~     treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin~     plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may~     obtain better tumor remission rate, improve the prognosis of the patients.~   "
90520|NCT01872403|"~     Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung~     squamous cell carcinoma has a better tumor response rate and safety, therefore.The main~     purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel /~     carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.~   "
90521|NCT01872390|"~     The purpose of the START Study is to identify an effective, cost-effective, acceptable~     intervention that addresses programmatic, structural and psychosocial barriers to ART~     initiation and retention during TB treatment, with the ultimate goal of improving health~     outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster~     randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV~     clinics in Berea district. Clinics are randomized to deliver the combination intervention~     package (CIP) or standard of care (SOC), with stratification by facility type. The~     experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV~     clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures~     for ART initiation and retention will be delivered.~      Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.~      Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP~     clinics will have superior HIV- and TB-related outcomes, including:~        -  Greater ART initiation during TB treatment~        -  Shorter time to ART initiation~        -  Greater retention in ART care~        -  Higher adherence to ART~        -  Greater change in CD4+ count~        -  Greater TB treatment success (completion and cure)~        -  Greater sputum smear conversion~        -  Higher adherence to TB treatment~      Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable~     than alternative resource uses.~   "
90522|NCT01872377|"~     Currently the standard treatment for locally advanced, unresectable pancreatic cancer~     consists either of chemotherapy by itself or a combination of chemotherapy plus radiation~     therapy or no treatment at all. Unfortunately, no treatment thus far has been able to~     provide patients with a consistent chance for a cure although there are rare patients who~     will live for many years after treatment. For most patients the chemotherapy or chemotherapy~     plus radiation will maintain or improve quality of life by keeping the cancer under control~     for a period of time.~      Approximately 25-30% of patients with early pancreatic cancer who are able to have the~     cancer completely removed surgically will live beyond 5 years and will be considered cured.~     This tells us that aggressive treatment directed at the tumour in the pancreas can lead to~     cure. For the majority of patients who can not have an operation, giving more radiation as~     part of the treatment may be a strategy that results in better control of the tumour in the~     pancreas which may or may not result in patients living longer.~      The purpose of this study is to test the safety of adding a higher dose (a boost dose) of~     radiation using a radiation unit called CyberKnife when combined with standard chemotherapy~     and radiation for patients with locally advanced, unresectable pancreatic cancer.~      Participants on this study will receive a 'boost' dose of radiation which consists of 3~     treatments over 1 week. The participants will then receive the standard of care treatment of~     chemotherapy and standard radiation therapy over a 5 week period, which will be followed by~     the conventional 20 weeks of chemotherapy alone. The participants will then be followed for~     progression of disease and toxicity related to the boost treatment for up to 5 years.~   "
90523|NCT01872364|"~     Expenditures on material supplies and medications constitute the greatest per capita costs~     for surgical missions. We hypothesized that supply acquisition at nonprofit organization~     cost would lead to significant cost-savings compared to supply acquisition at US academic~     institution costs from the provider perspective for hernia repairs and minor procedures~     during a surgical mission in the Dominican Republic.~   "
90524|NCT01872351|"~     The purpose of this study is to determine whether therapy that has been shown to be~     beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS)~     patients. This study is a chart review of previous CFS patients who received daily~     conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed~     nutraceutical supplements included alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids~     (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.~      Twelve CFS male and female patients between the ages of 20-70 years will be recruited to~     participate in this pilot study. Subjects will be eligible to participate if they meet the~     criteria for CFS of the Centers for Disease Control and Prevention (CDC). These include~     persistent, unexplained fatigue for at least 6 months, concurrent with four of the~     following: impaired memory/concentration, sore throat, new headaches, unrefreshing sleep,~     muscle pain, multi-joint pain, tender lymph nodes, and post-exertional malaise.~   "
90526|NCT01872325|"~     The main goal of this project is to help 9-1-1 emergency medical dispatchers save the lives~     of more cardiac arrest victims. The investigators will develop teaching tools to help the~     dispatchers recognize abnormal breathing that may indicate a victim as having a cardiac~     arrest. After training sessions, the investigators will see if dispatchers can get better at~     recognizing abnormal breathing, how often they give CPR instructions, and if use of the~     teaching tool will increase bystander CPR and the number of victims leaving the hospital~     alive.~   "
90527|NCT01872312|"~     This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.~   "
90528|NCT01872299|"~     SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological~     evaluation study, which is being conducted in 11 centres across six countries. SICA-HF~     receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013)~     under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and~     Education within the file transfer protocol R&D in priority fields of the S&T complex of~     Russia 2007-2012 under state contract number 02.527.11.0007. The aim of SICA-HF is to~     provide detailed characteristics of co-morbidities of heart failure at baseline and over~     time, particularly with regards to obesity, cachexia, and type 2 diabetes.~   "
90529|NCT01872286|"~     Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel~     disease. This study was aimed to compare the performance between the frequency-altering~     AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.~   "
90530|NCT01872273|"~     Moderate exercise is recommended to improve cardiovascular health in obese and overweight~     people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting~     blood sugar, and elevated blood lipids. This study is being done to determine how platelets~     respond when a person performs an initial period of moderate exercise.~   "
90531|NCT01872260|"~     The purpose of this trial is to inform the future clinical development of the two~     investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719~     (PI3K-alpha inhibitor).~      This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will~     estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with~     letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with~     letrozole using various regimens (Arms 3 to 5 ).~      The Phase Ib dose escalation part will be followed by a Phase Ib dose expansion in all five~     Arms to further characterize the safety, tolerability, PK and preliminary clinical~     anti-tumor activity of the combinations. Optional crossover is allowed for patients who have~     progressed while on dose escalation or dose expansion with doublets treatment on Arms 1 or 2~     to be treated with the triplet combination (Arm 3) after the determination of the RP2D for~     Arm 3.~      Approximately 300 adult women with ER+/HER2- locally advanced or metastatic breast cancer~     will be enrolled.~   "
90532|NCT01872247|"~     HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for~     ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications~     have compared the effectiveness of these compounds, in terms of clinical outcomes.~      The aim of our study is to investigate the effects of three different ovarian stimulation~     protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study,~     evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the~     biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the~     cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess~     the oocyte quality, as biological outcome. The clinical outcome was estimated measuring~     implantation and ongoing pregnancy rates within and between the three different ovarian~     stimulation protocols~   "
90533|NCT01872234|"~     The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial~     alternative to conventional medical therapy in patients with a history of moderate heart~     failure. The investigators are looking to enroll approximately 180 people in this trial.~     Patients will be randomized in two groups. One group will be implanted with a pacemaker and~     will continue to receive conventional medical therapy as prescribed by their doctor. The~     second group will continue to receive conventional medical therapy as prescribed by their~     doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and~     external device testing will be collected both at the time of enrollment in the trial and~     during follow-up study visits. Patients who enter the study will be seen for study visits at~     1 month, 3 and 6 months.~   "
90534|NCT01872221|"~     This is a prospective biomedical study of interventional type which includes 16 patients on~     52 months (24 months of inclusion and 28 months of follow up).~      This pilot study, combining a metabolic imaging approach (Proton Magnetic Resonance~     Spectroscopy = 1HMRSI) and a biological one, will be performed in patients harbouring a~     Glioblastoma (GBM)to determine whether MRI markers of aggressiveness (CNI2) are associated~     with specific biological patterns as regards to GBMSC (GBM contains tumor stem cell).~      In the first part of the study, patients with radiological criteria of GBM amenable to~     surgical resection will be included ; pre-operative multimodal MRI scans will be done and~     all data acquired (including H1MRS and DTI data) will be integrated in the image-guided~     surgical device (ie neuronavigation system) to be used intraoperatively. During tumor~     resection, tissue samples will be individualized, based on their multimodal imaging~     characteristics and sent to the radiobiology laboratory INSERM for biological analysis.~      After surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and~     will be followed according to standard practices; multimodal MRI will be performed every 2~     months during the first year and then every 3 months until progression.~   "
90535|NCT01872208|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in~     the creation of an above-knee femoro-popliteal bypass graft in patients with peripheral~     arterial disease.~   "
90547|NCT01872039|"~     To compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and~     non-weight-based) for the treatment of Chinese hypertensive emergency patients.~   "
90548|NCT01872026|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after oral administration to patients with chronic kidney disease undergoing~     hemodialysis.~   "
90536|NCT01872195|"~     This project aims to produce a systematic review on present knowledge on effects of using~     safety checklists in medicine. Implementation of a checklist system throughout surgical care~     may reduce patient morbidity and mortality. The reliability of patient data is crucial to~     make firm conclusions as to such effects. This project aims to investigate if such morbidity~     and mortality effects are obtainable in two Norwegian hospitals while at the same time~     making a crucial evaluation of the patient data used in this study itself.~      We hypothesise~        1. An updated systematic review of the research literature provide evidence that safety~          checklists use does enhance safety and reduces patient mortality and morbidity~        2. Implementation of the patient safety checklist system will reduce patient mortality and~          morbidity in the checklist cohort, and subsequent effects on length of stay~        3. The sensitivity and specificity of ICD-10 coding vs. medical journal information is~          poor, with study results to be adjusted accordingly.~   "
90537|NCT01872182|"~     The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in~     patients with abdominal obesity of metabolic syndrome.~   "
90538|NCT01872169|"~     Gastroenterological disorders are disorders affecting the stomach, intestines and associated~     organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea,~     weight loss and loss of appetite. Due to the nature and symptomatology of these disorders~     research has suggested that sufferers may be vulnerable to developing disordered eating~     behaviours. Treatment of such disorders often requires dietary restriction which has been~     found to lead to an obsessive preoccupation with food and in some cases to an increase in~     binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting~     have also been suggested to be linked with disordered eating. At the present there is~     limited research in this area and as such evidence is inconclusive. Particularly little~     research has looked at this area in relation to adolescents, who have been recognised as~     being at increased risk for the development of disordered eating . Gastroenterological~     disorders are likely to affect the typical development of eating habits and therefore it~     seems plausible they may also predispose adolescents to developing abnormal eating~     behaviours /weight concerns.~      The aim of this study is to further investigate the possibility that Gastroenterological~     disorders may be a risk factor for disordered eating in children and adolescents. This study~     will recruit children/ adolescents aged 5-17 and their parents, who are attending Great~     Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire.~     The recruitment process will be on going for around 5 months until the study has around 300~     participants. Following this initial questionnaire, participants who are categorised as~     screening positively for disordered eating and a 10% sample of participants that screen~     negatively, will be contacted to complete a further questionnaire interview that will look~     more specifically into this area.~   "
90539|NCT01872156|"~     The purpose of this study is to evaluate the effectiveness of the behavior treatment~     accompanied by self-help materials in Primary health care, across the intervention of the~     midwifes in the pregnancy follow-up visits.~   "
90540|NCT01872143|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) is effective in the treatment of psychiatric disorders in which available treatments~     are either ineffective or not tolerated~   "
90541|NCT01872130|"~     The purpose of this study is to evaluate a new instrument that shines light and takes~     digital pictures of skin. The goal is to develop a technique that may enable fast and~     accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or~     squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the~     confocal microscope to determine whether this technique may be useful in the future for~     helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter~     surgery and improved care.~   "
90542|NCT01872117|"~     The deep heat therapies are increasingly frequent in daily physical therapist for the~     treatment of musculoskeletal diseases. The use of such procedures is justified by their~     analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. However, studies on the~     cardiovascular effects of these therapies are still incipient. Therefore, this study has as~     objectives: map the skin temperature changes in the lower limbs in different areas and~     positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic~     cardiovascular parameters, and investigate the occurrence of changes in conduction velocity~     superficial blood resulting from the application of these thermal features. The study will~     be conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit~     the inclusion and exclusion criteria of the study. The analysis by infrared thermography~     will be held in a room with temperature maintained at 23 ± 1°C and humidity average 50%. The~     volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize~     skin temperature with temperature of the room. After this period will be held applying~     diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb~     regions of the hamstrings and triceps surae in extension and flexion to 180° to 90°. The~     records beat to beat blood pressure and heart rate to autonomic and cardiovascular~     hemodynamic evaluation will be performed by means of equipment Finometer (Finapress Medical~     Systems, Inc.) and electrocardiogram (ADInstruments, Inc.), respectively, before and after~     application of diathermy. On the other hand, the images will be processed using FLIR~     ThermoScan and blood flow data will be collected through the Doppler ultrasound. The results~     will be processed and analyzed using descriptive statistics, submitted to a linear~     regression model with mixed effects (random effects and fixed), with p≤0.05.~   "
90543|NCT01872104|"~     This research is a prospective randomized controlled trial.It aimed to determine longterm~     outcomes and factors associated with increased survival after photodynamic therapy (PDT)~     through colonscopy compared with chemotherapy alone in patients presenting with advanced~     rectal cancer.~   "
90544|NCT01872091|"~     Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature~     and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries~     and veins resulting in decreased blood flow. Thus, this study aims to evaluate neuromuscular~     and biomechanical assess hemodynamic and autonomic cardiovascular, and investigate the~     occurrence of changes in conduction velocity due to the superficial blood cryotherapy by~     immersion of the forearm. The study will be conducted in 40 volunteers, female, between 18~     and 30 years, university, healthy. They will be divided into two groups of 20 volunteers,~     the group immersion cryotherapy (GI) and control group (CG). For immersion cryotherapy group~     (GI), individuals will be the right arm to the elbow immersed in a container of water at 6°C~     ± 2°C for 15 minutes. In the control group (CG), volunteers will remain at rest with the~     right arm in the same position within a vessel containing water at a temperature indifferent~     for the same period of 15 minutes. The temperature analysis is performed using a infrared~     thermographer, muscular strength and synergism will be evaluated by a load cell connected to~     the electromyograph to examine muscle activation of wrist flexors and extensors, serratus~     anterior, upper and middle trapezius. The records beat to beat blood pressure and heart rate~     for cardiovascular autonomic and hemodynamic evaluation will be carried out by means of~     equipment and Finometer electrocardiogram, respectively, before and after application of~     cryotherapy. In turn, the data of blood flow velocity will be collected by means of Doppler~     Ultrasound. The results will be processed and analyzed using descriptive statistics,~     submitted to a linear regression model with mixed effects (fixed and random effects), with~     p≤0.05.~   "
90545|NCT01872078|"~     To assess the effects of AZD4901 when given in multiple doses to females with Polycystic~     Ovary Syndrome~   "
90550|NCT01872000|"~     Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority~     of people develop an operable cataract when they are over the age of 50. Occasionally people~     under 50 years develop a cataract requiring an operation. The visual demands in this age~     group are very different due to both physiological and lifestyle factors. Traditionally IOLs~     are focussed for distance vision and additional spectacles are worn for near vision. Under~     the age of 45 years we have the ability to naturally change the focus of our eyes and do not~     require additional reading glasses. This is known as accommodation. By removing the~     cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work~     together for distance vision but only the unoperated eye is able to change focus for~     different working distances. This study aims to establish whether a multifocal IOL implanted~     in one eye is able to complement the accommodation in the other eye so the 2 eyes work more~     effectively together. This may enhance depth perception and improve the quality of vision.~     Depth perception is important for more comfortable vision on the computer screen, when~     reading and for jobs that require good depth perception.~   "
90551|NCT01871987|"~     A study to evaluate the effect of food on the plasma concentration changes of quetiapine~     after oral administration of FK949E (extended release formulation of quetiapine) in healthy~     male subjects.~   "
90552|NCT01871974|"~     The objective of the study was to evaluate the safety and plasma concentration changes of~     quetiapine after multiple oral administration of FK949E (extended-release formulation of~     quetiapine) in patients with major depressive disorder (MDD).~   "
90553|NCT01871961|"~     To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the~     Metoject® prefilled pen (including a label comprehension assessment and a device robustness~     evaluation).~   "
90554|NCT01871948|"~     Cancer patients often experience problems in their care, many of which are caused by~     communication breakdowns. Some communication breakdowns lead to adverse events and even~     harmful errors. Deficiencies in provider-patient communication can compound patients'~     distress, lower the quality of care, and disrupt patient-provider relationships. There is~     little research on patients' and providers' experiences of the communication breakdowns that~     precipitate adverse events and errors, or on effective responses to these events. Because of~     this, cancer providers are unsure how to communicate with patients in these difficult~     situations. The goal of the proposed study is to improve patient-centered communication~     around adverse events and errors in cancer care. Our specific aims are: 1) To describe~     patients' experiences with communication around adverse events and errors in cancer care, 2)~     To describe providers' experiences and practices with communication around adverse events~     and errors in cancer care, 3) To develop practical recommendations, provider training~     materials and patient educational materials for improving communication around adverse~     events and errors in cancer care, 4) To disseminate the recommendations and materials~     through three health plans, and 5) To conduct a preliminary evaluation of the perceived~     usefulness and impact of the materials. The investigators will first conduct interviews with~     breast and colorectal cancer patients who have experienced adverse events or errors at 3~     Cancer Research Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and~     Worcester, Massachusetts). The interviews will focus on instances where patients believe~     that better communication might have prevented an adverse event or error, or mitigated the~     event's impact. Next the investigators will conduct focus groups to understand providers'~     attitudes and experiences with these communication dilemmas, and use simulations to describe~     providers' communication practices. Finally, the investigators will interview health plan~     leaders to identify the systems factors that influence communication with patients around~     adverse events and errors. These perspectives will be synthesized to create patient and~     provider educational material for improving communication. Three advisory panels: a Patient~     Advisory Panel, a Health Plan Advisory Panel and a Dissemination Advisory Panel (including~     all 14 CRN health plans) will help create and disseminate these educational interventions.~     Dissemination will occur at the three core clinical sites. The investigators use patient and~     provider surveys to evaluate the educational materials' impact. This evaluation will provide~     the evidence-base to refine the study products before widespread dissemination throughout~     the CRN and beyond. The project will have the advantage of the CRN infrastructure, the CRN~     Clinical Communication Research Center, and is led by nationally recognized communication~     researchers.~   "
90555|NCT01871935|"~     Induction of general anaesthesia with a combination of opiates and hypnotics often induces~     vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure~     (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize~     tissue oxygenation, particularly cerebral oxygenation. Previous research of the~     investigators group has revealed that atropine has an exceptionally beneficial effect on the~     determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators~     have demonstrated a significant and clinically relevant increase in CO and cerebral tissue~     oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more~     usual clinical practice of administrating classical vasoactive medication such as~     phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and~     SctO2. In previous research the investigators used standardized target controlled~     propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known~     that remifentanil has more intense haemodynamic side-effects compared to other opiates such~     as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial~     effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally~     valid during anaesthesia of propofol combined with other opiates such as sufentanil.~      Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep~     general anaesthesia, which is usually performed with the combination of drugs as mentioned~     above. Because these patients often experience severe haemodynamic fluctuations they need to~     be closely monitored.~   "
90556|NCT01871922|"~     Remifentanil is a widely used potent intravenous opioid with the advantage of having a short~     time of action. Compared to other opiates however remifentanil generates more intense~     hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges~     necessitate the administration of a combination of relatively high doses of analgesics on~     the one hand and a short time for postoperative recovery from anesthesia on the other. For~     these reasons, anesthetic management often consists of a combination of relatively high~     doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil~     anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous~     research of the investigators group has revealed that atropine has an exceptionally~     beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the~     investigators hypothesize that administration of intravenous atropine during induction of~     propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral~     and cerebral tissue oxygenation during and after induction of anesthesia.~   "
90557|NCT01871909|"~     Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in~     humans. The investigators hypothesize that the physiologic changes that occur with~     application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma~     patients, and that LBNP is a truly valid model of human hemorrhage.~   "
90565|NCT01871805|"~     This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of~     CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed~     crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of~     CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib~     treatment will receive the recommended phase II dose (600 mg) daily in two oral doses.~   "
90558|NCT01871896|"~     Morbid obesity and its associated metabolic diseases are on the rise in the United States.~     Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric~     bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients~     who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess~     body weight loss or regain of weight. For those patients who fail to lose weight after~     bariatric surgery and have failed maximal medical therapy and diet supervision, the~     treatment is re-operation and revision. Re-operation of the abdomen carries significant~     postoperative morbidity and mortality. The investigators propose to use the Apollo~     OverStitch endoscopic suturing device that has already been approved by the FDA as an option~     for bariatric surgery revision without having to re-operate on the patient. The~     investigators believe that the endoscopic technique may be able to provide weight loss~     without having to re-operate on the patient.~   "
90559|NCT01871883|"~     Sensitive skin syndrome is defined as the presence of burning, itching or any other~     unpleasant sensation on the skin, due to physical, chemical or psychological factors. It is~     frequently a self-diagnosed condition, and there are no accurate tests to recognize or~     quantify it because of the individual variations in perception and intensity of the related~     symptoms. The most accepted physiopathogenic theory is the presence of an altered barrier~     function of epidermis. Also, changes in the pH of the stratum corneum have been found to~     induce skin sensitivity through the activation of the transient potential receptor vanilloid~     (TRPV) neuronal receptors.~      TRPV1 has been found in human keratinocytes, although its physiologic role in the skin is~     not yet established. Their presence in keratinocytes and cutaneous nervous fibers suggests a~     role in the sensitive function of the epidermis. Since this receptors can be activated by~     low pH (< 5.9), which is also important for the development of sensitive skin, we~     hypothesized that an increase in the expression of these receptors can be the responsible~     for the syndrome.~   "
90560|NCT01871870|"~     The objectives of this outpatient research study are (1) to assess the ability of this~     automated system to be operated by a subject with limited professional oversight; (2) to~     assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump~     controller) will reduce the frequency of hardware and data communication lapses seen in the~     previous system; and (3) to measure the degree of glucose control achievable with this~     automated system. The system will adjust blood glucose by administering insulin and~     glucagon. Insulin is a hormone that lowers blood glucose and will be given nearly~     continuously during this study. Glucagon raises blood glucose and will be automatically~     administered during hypoglycemia. Both are natural hormones made by people without diabetes.~     Each subject will have four devices placed on his abdomen: two Omnipod insulin pumps, one~     for delivering insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors~     for measuring glucose. The two sensors will feed glucose data into Motorola smart phone~     master controller, which will calculate the correct amount of insulin or glucagon to~     deliver. The system will then send the command to the correct Omnipod through the iDex pod~     controller.~      In this new system, the research subject will be able to monitor the progress of the study~     by use of the smart phone graphical user interface. The subject will have a companion with~     him/her during the entire study for safety purposes. Both the subject and companion will~     complete a training course on how to treat diabetic emergencies and how to operate the~     system. A study physician and technician will be in the hotel during each study and will be~     monitoring the study via a cloud-based data communication system. These studies will be~     carried out in a hotel setting.~   "
90561|NCT01871857|"~     Research suggests that hypertonic saline may improve mucous flow in infants with acute~     bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved~     pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as~     compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has~     not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve~     bronchiolitis severity scores and admission rate.~   "
90562|NCT01871844|"~     This was a within group, randomised, repeated dose, placebo- and octreotide controlled study~     in a target population of 45 healthy male subjects. Subjects were required to attend the~     clinical for screening procedures between 3 and 28 days before dosing commenced. The study~     was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised~     design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9~     subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow~     for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group~     4 (the active control group) was still to proceed if the decision was taken to prematurely~     stop dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data~     presented at the interim decision meeting; dosing of this group was conducted independently~     from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of~     investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were~     to receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled~     to receive their final dose of IMP on the morning of Day 7.~      In addition, subjects were to receive exogenous test administrations(stimulation test) on~     Day -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first~     dose of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day).~     Blood samples for PD and PK analyses were taken at specified time points after each dosing.~      Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7)~     providing that discharge conditions had been met, and returned to the clinic between 5 and~     10 days after the last IMP administration for a follow-up visit.~   "
90563|NCT01871831|"~     Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can~     be affected by the partial pressure of oxygen of the blood sample. In this study, we~     investigate the influence of different partial pressure of oxygen in blood samples on~     measurement results. Systems with labelled oxygen-dependency as well as systems without~     labelled oxygen-dependency are evaluated.~   "
90564|NCT01871818|"~     The purpose of this study was to compare the effectiveness of two rehabilitation programs~     (one month) in patients with multiple sclerosis. The first program is combined with~     physiotherapy, endurance training and resistance training. The second one is physiotherapy~     in private practice. Another purpose is to assess the length of the benefits of the combined~     program.~   "
90566|NCT01871792|"~     Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic~     contrast administration and is associated with increased short- and long-term mortality.~     Previous strategies including forced diuresis with diuretics or mannitol, intravenous~     administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN~     have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has~     yielded conflicting outcomes.~      A review of a large insurance database and retrospective study have shown that statins~     therapy is associated with a lower incidence of CIN after percutaneous coronary~     intervention. The preventive effect of statins on CIN may be attributed to direct~     pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction,~     anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not~     demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.~      Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal~     dysfunction undergoing coronary angiography or intervention.~   "
90567|NCT01871779|"~     Cardiovascular disease remain one of the leading causes of death in Australia, accounting~     for 47637 (36%) of deaths in 2004.~      Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by~     intermittent claudication. This is defined as walking induced pain, cramping, aching,~     tiredness or heaviness in one or both legs that does not go away with continued walking and~     is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years~     suffer from claudication. The primary and most effective treatment for these patients is~     focused on improving walking ability and functional status.~      Current research has shown that approximately 30% of patients improve with exercise, while~     30% continue to deteriorate and the rest show no change. The changes produced at a~     biochemical and cellular level due to exercise are unknown. To help better understand this,~     our study will assess the entire range of proteins expressed before and after exercise in~     the skeletal muscle tissue of patients with intermittent claudication. This will help to~     identifying key proteins that have a role in improving patient symptoms and outcome.~   "
90568|NCT01871766|"~     This study will treat participants with newly diagnosed, low, intermediate and high risk~     rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or~     intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk~     participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with~     anti-angiogenic chemotherapy.~      PRIMARY OBJECTIVE:~        -  Estimate event-free survival for intermediate risk participants treated with~          vincristine, dactinomycin and cyclophosphamide with the addition of maintenance~          anti-angiogenic therapy.~      SECONDARY OBJECTIVES:~        -  Estimate the false negative rate and incidence of additional positive lymph nodes in~          participants undergoing sentinel lymph node biopsy followed by limited nodal~          dissection.~        -  Maintain a high local control rate in participants treated with surgery and/or limited~          volume proton and photon radiation without dose escalation.~        -  Define the incidence and type of failure in participants who receive risk-adapted local~          therapy relative to the primary tumor volume.~        -  Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic~          chemotherapy in intermediate and high risk patients following standard chemotherapy.~        -  Estimate the event free survival for high risk patients receiving interval dose~          compressed therapy and maintenance anti-angiogenic therapy.~        -  Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2~          toxicities) related to proton beam therapy.~   "
90569|NCT01871753|"~     The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant~     recipients with asymptomatic bacteriuria.~   "
90570|NCT01871740|"~     The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is~     more effective in preventing renal function decline among the patients with primary~     hypertension when compared to enalapril maleate.~   "
90571|NCT01871727|"~     The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity~     ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in~     dose-finding part will be used to determine the dose of E7777 that should be used to test~     efficacy and safety.~   "
90572|NCT01871714|"~     The current study design incorporates two previously developed, non-invasive approaches to~     characterize the phenotype of individuals affected with XLHED.~   "
90573|NCT01871701|"~     To evaluate the corrected QT interval change(automatic-reading) after single oral~     administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean~     Adults.~   "
90574|NCT01871688|"~     As cancer treatment improves, the cancer survivor's quality of life and level of function~     have gained increasing importance. Pelvic floor function is directly affected by~     gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a~     patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of~     PFD provides information about the disease burden and treatment-related effects directly~     from the patient's perspective and informs clinical decision-making. The pelvic floor~     musculature and sacral nerves are not easily accessible, and it is difficult to test them.~     Several functional assessments have been used to evaluate pelvic floor dysfunction; however,~     reports on methodology are sparse, and consensus on their use is lacking. Research on~     functional outcomes is highly complex and, consequently, must be addressed in a~     comprehensive framework.~   "
90575|NCT01871675|"~     The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and~     preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine~     plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.~   "
90576|NCT01871662|"~     The purpose of this study is to explore whether silibinin plus ribavirin with/without~     peg-interferon can be more effective than the peg-interferon plus ribavirin based standard~     of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.~   "
90595|NCT01871415|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy, safety and tolerability of aleglitazar in combination with metformin in patients~     with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy.~     Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo~     for 26 weeks in combination with their pre-existing metformin regimen and dose.~   "
90577|NCT01871649|"~     The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial~     of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients~     with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate~     alone is started. Golimumab will be discontinued.~      Hypotheses:~      First, the investigators hypothesize that initiation of a combination therapy with golimumab~     + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the~     percentage of patients achieving Disease Activity Score (the investigators hypothesize that~     more patients with the early combination treatment will respond (according to Disease~     Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis~     Response Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or~     Minimal Disease Activity (MDA) than patients on MTX alone.~      Third, the investigators hypothesize that a significant proportion of the patients will~     continue to benefit from this early aggressive treatment initiation even after stopping~     golimumab treatment.~   "
90578|NCT01871636|"~     Conventional techniques of endoscopic mucosal resection (EMR) by snare resection do usually~     not achieve resection of gastrointestinal mucosal neoplastic lesions larger than 1 cm in~     diameter in a single piece. Complete R0 resection cannot be histologically confirmed. In~     contrast to EMR the technique of endoscopic submucosal dissection (ESD) allows en-bloc~     resection even of large neoplastic lesions. The waterjet-assisted ESD technology (WESD)~     allows pressure controlled injection of fluids through the tip of a recently developed~     HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as~     well as coagulation of bleeding sources can be performed with the same device without need~     for changing the instrument. Our group reported on effective en-bloc resection of esophageal~     areas in all of 14 cases of an Erlangen porcine model. We subsequently compared WESD with~     EMR of predefined esophageal mucosal lesions in anesthetizised pigs in a randomized~     controlled trial. The results demonstrated that WESD more frequently achieved a complete~     resection with a significantly lower number of specimen. WESD caused no perforations and~     bleedings could be endoscopically managed during the procedure. In addition we recently~     reported on this technology in a first clinical trial on WESD for early Barrett`s neoplasia~     . The results indicated that WESD can be safely and effectively performed in the esophagus.~      Therefore the primary objective of this study is to compare the R0 resection rate of ESD and~     EMR for visible lesions of HIgh grade intraepithelial neoplasia (HGIN) or esophageal~     adenocarcinoma (EAC). Secondary objectives are related to completeness of resection, safety~     of the procedures, the medium term outcome and comparison of costs.~   "
90579|NCT01871623|"~     Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface~     retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced~     by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In~     patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can~     be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy~     is another useful surgical modifications that can be easily done through the alveolar cleft.~     It is performed to allow the correction of differences in the occlusal planes, correction of~     transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is~     that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed~     to have successful result can be narrow down or even closed by approximation of two~     separating alveolar segments. However, there are limited previous studies comparing the~     stability of segmental versus one-piece Le Fort I osteotomy especially in patients with~     cleft. It is our aim to investigate whether one-piece Le Fort I osteotomy or segmental Le~     Fort I osteotomy can provide a better stability after surgery.~   "
90580|NCT01871610|"~     There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago~     and GCS=13-15 will be recruited. Another group of 200 participants with the same age and~     gender and without TBI will be recruited as the controls. All of them will undergo AD8~     questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be~     tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2.~     10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for~     AV45 amylid PET study.~      There will also be 10 participants without traumatic brain injury and interested in this~     study, aged 55 years or older better.~   "
90581|NCT01871597|"~     Video assisted thoracoscopic surgery (VATS) anatomical lung resections (lobectomy or~     pneumonectomy) provide an effective minimally invasive treatment for stage 1 lung cancer.~      Currently, a minority of anatomical pulmonary resections are being performed by VATS (15%)~     (6). The technical difficulty and danger of VATS lobectomy is related to pulmonary arterial~     branch manipulation and this is the main limitation of many thoracic surgeons regarding the~     adoption of VATS lobectomy. We believe that if we can decrease the manipulation required by~     the surgeon on the pulmonary arterial branch, we can make these procedures safe and~     therefore more prevalent for anatomical pulmonary resections.~   "
90582|NCT01871584|"~     The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in~     order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy~     to standard preparation solution.~      Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard~     preparation solution.~   "
90583|NCT01871571|"~     This phase II trial studies how well bevacizumab, fluorouracil, leucovorin calcium, and~     oxaliplatin before surgery works in treating patients with stage II-III rectal cancer.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Drugs used in chemotherapy, such as fluorouracil,~     leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab~     together with fluorouracil, leucovorin calcium, and oxaliplatin may be an effective~     treatment for rectal cancer.~   "
90584|NCT01871558|"~     To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus~     SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.~   "
90596|NCT01871402|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
90585|NCT01871545|"~     The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States.~     Although imaging plays a major role in HCC screening and staging, the possibility of~     predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet~     needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate~     the use of new imaging criteria beyond size. The investigators would like to develop and~     validate non-invasive magnetic resonance imaging (MRI) methods based on advanced~     diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI~     and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive~     markers of major histopathologic features of HCC, and to predict and assess early response~     of HCC to systemic therapy. The investigators also would like to develop quality control~     tools to improve the quality and decrease variability of quantitative MRI metrics. These~     techniques combined could represent non-invasive correlates of histologic findings in HCC,~     could enable individualized therapy, and provide prognosis in patients with HCC.~   "
90586|NCT01871532|"~     This is a prospective, multicenter, open-label, comparative and parallel-group study of~     ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH)~     treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2~     anovulatory subjects who have previously failed to conceive with clomifene treatment.~   "
90587|NCT01871519|"~     The study objective is to collect and report 12-month outcomes pertaining to activities of~     daily living, quality of life, and safety parameters in a Medicare population to be treated~     with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression~     fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to~     show statistically significant improvement from baseline in the four co-primary endpoints~     (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if~     the primary objective is met. New radiographic fractures, non-surgical management received,~     VCF-related healthcare resource utilization, and vertebral body height restoration data will~     also be collected.~   "
90588|NCT01871506|"~     There are currently over 11 million cancer survivors in the U.S. and survival rates are~     increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of~     diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial~     vulnerabilities. Documented risks associated with continued smoking following cancer~     diagnosis include decreased survival time; increased complications from surgery, radiation,~     and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health &~     Human Services Public Health Service evidence-based tobacco treatment guidelines exist but~     have not been integrated into the cancer setting. This is a tremendous missed opportunity to~     address a modifiable risk factor. In recognition of this treatment gap, the National Cancer~     Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and~     capacity for delivery of tobacco treatment in Cancer Centers. The American Society of~     Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by~     their second oncology visit as a core quality indicator; however, currently only half of~     patients report being asked about tobacco use.~      Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two~     strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.~      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll~     295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast,~     genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be~     randomly assigned to receive Intensive Counseling (IC) or Standard Care (SC). Both groups~     will receive an initial motivational counseling session and 3 weekly follow-up counseling~     sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm~     has the option to also receive:~        -  Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation~          medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.~        -  Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling~          sessions with a tobacco treatment counselor (total of 11 counseling contacts).~      All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months.~     Self-reported abstinence will be biochemically confirmed at 3 and 6 months.~   "
90589|NCT01871493|"~     The main purpose of this study is to evaluate how the body absorbs and removes LY2605541,~     insulin lispro, and a mixture of both from the blood. The study has two parts. Participants~     may enroll in only one part. Each part has four treatment periods in a fixed order. The~     study will last approximately 8 weeks, not including screening. Screening is required within~     28 days prior to the start of the study.~   "
90590|NCT01871480|"~     Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC)~     comprises about 85% of all lung cancer cases, which is the leading cause of cancer~     mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower~     efficiency of treatment as second or third-line in patients with advanced adenocarcinoma~     NSCLC. It is necessary to further improve the efficiency of treatment in patients with~     advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor~     control and survival, as well as a better quality of life. This study is to evaluate the~     efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic~     adenocarcinoma NSCLC.~   "
90591|NCT01871467|"~     Previous studies have demonstrated a deficiency of blood dendritic cells in patients with~     kidney disease that is associated with the development of viral infections after kidney~     transplantation. We plan to test the ability of sargramostim to increase blood dendritic~     cell levels in patients with kidney disease in the hopes of developing new therapies to~     prevent viral infections after kidney transplantation.~   "
90592|NCT01871454|"~     The objective of this prospective phase II protocol is to assess the toxicity and efficacy~     of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers~   "
90593|NCT01871441|"~     This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant~     works in treating patients with hematologic malignancies. Giving chemotherapy and total-body~     irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It~     may also stop the patient's immune system from rejecting the donor's stem cells. Giving an~     infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune~     cells and help destroy any remaining cancer cells. When the stem cells from a related donor,~     that closely matches the patient's blood, are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~   "
90594|NCT01871428|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2~     diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be~     randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.~   "
90654|NCT01870635|"~     The primary objective is to determine if the administration of a single dose of oral~     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in~     intravenous (IV) rehydration therapy in children presenting for emergency department care~     with vomiting and diarrhea in Pakistan.~   "
90597|NCT01871389|"~     Vitamin D deficiency is common after bariatric surgery. This study is designed to determine~     if a high dose monthly supplement of vitamin D 3 will be effective in helping improve~     vitamin D status after surgery such as gastric bypass. Bariatric surgery subjects taking~     monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol~     will have a significant rise in serum vitamin D levels compared to the subjects taking only~     the usual vitamin D protocol.~   "
90598|NCT01871376|"~     To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment~     of PCV~   "
90599|NCT01871363|"~     Pathological complete response, (pCR) correlates with a favourable overall prognosis in~     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining~     a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of~     preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is~     pathological complete remission rate.~   "
90600|NCT01871350|"~     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively~     influencing their quality of life, treatment response and survival. Weight loss has been~     reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the~     consequence of energy imbalance and disturbances in protein metabolism (through different~     factors linked with chemotherapy), such as reduced caloric and protein intake (partly~     related to depression), poor treatment tolerance, hormonal alterations, systemic~     inflammation etc. This results in body composition modiﬁcations in favor of fat gain and/or~     lean body mass loss in early stage cancer and loss of both fat mass and lean mass in~     advanced cancer. Depletion of lean tissue in cancer patients is related to short survival,~     and decreased skeletal muscle mass and function may result in fatigue and inactivity, which~     contributes to fat mass changes and can be responsible for chemo-toxicity and increased~     mortality.~      Gains in muscle mass are difficult to achieve in cancer unless specific metabolic~     abnormalities are targeted. Recently, the investigators observed that essential amino acid~     mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV~     non-small cell lung cancer. Previous experimental research and clinical studies in cachectic~     conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to~     attenuate protein degradation by improving the anabolic response to feeding and by~     decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with~     docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several~     disease states; however, weight and muscle mass gain was not present or minimal. Recent~     studies examining the effect of fish oil supplementation in relation to chemotherapy have~     been inconclusive but found potential beneficial effects on physical performance and~     increased efficacy of first-line chemotherapy in patients with non-small cell lung cancer.~      It is the investigators' hypothesis that supplementation with milk protein (containing~     essential amino acids) carbohydrate (CHO) mixture in combination with fish oil~     supplementation will target the metabolic alterations in cancer patients receiving~     chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass~     and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.~   "
90601|NCT01871337|"~     This study will examine whether the Paula method is an effective treatment for UI and the~     correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise~     method that significantly decreased urinary incontinence in women with MIX in two randomized~     controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The~     secondary aim is to evaluate the effectiveness in terms of MS general physical functioning,~     quality of life and sexual function and to detect adherence and continuity six months post~     intervention.~   "
90602|NCT01871324|"~     The purpose of this study is to compare the influence of an intervention program especially~     designed to young ultra orthodox men that were diagnosed with diabetes type one.~   "
90603|NCT01871311|"~     The purpose of this study is to determine the recommended Phase II dose of nilotinib when~     used in combination with cetuximab in the treatment of patients with recurrent and/or~     metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.~   "
90604|NCT01871298|"~     The purpose of this exploratory study is to examine factors associated with frequency and~     type of internet and mobile technology use among illegal drug users, specifically use of~     internet and text-messaging to obtain health care information and engage in health care~     utilization, specifically human immunodeficiency virus (HIV) prevention and treatment~     services. We will target high drug activity neighborhoods in New York City and enroll~     participants recruited through targeted street outreach. All participants (n=336) will~     undergo an audio computer-assisted self-interview (ACASI) that will assess~     sociodemographics, health care access and utilization, sex/drug use behavior, health status,~     and characteristics of general and health-related internet/mobile technology use including~     factors that promote or hinder use. Participants identified as using the internet ≥1/month~     (n=151) will return for a 4-week ACASI to report on use of the pilot website (which will~     largely display information currently available in the community in print/ pamphlet/ video~     form).~   "
90605|NCT01871285|"~     The primary aim of this study is to determine if chronic pain subjects on around-the-clock~     opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely~     transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose~     without inducing opioid withdrawal or reversing analgesic effects.~   "
90606|NCT01871272|"~     PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus~     surgery and identify factors associated with good and bad outcome after surgery.~   "
90607|NCT01871259|"~     To relate two different predictive values of sleep apnea: the STOP score (snoring while~     sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the~     estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during~     propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under~     spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a~     STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade,~     tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be~     infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal~     cannula, will be then applied to estimate the level of apnea-hypopnea.~   "
90608|NCT01871246|"~     People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to~     establish an active lifestyle are challenging because of periodic acute exacerbations of~     COPD that interrupt physical activity patterns and contribute to further decline in physical~     activity. The purpose of this preliminary research is to learn more about the experience of~     acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family~     and to learn how AECOPDs affect physical activity.~   "
90695|NCT01870102|"~     Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate~     the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR~     (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label,~     single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR~     (Pelubiprofen 45 mg) in healthy male volunteers~   "
90609|NCT01871233|"~     The Extended Access Program (EAP) is a managed access programme for Perampanel. The main~     objective of this EAP is to ensure that patients participating in studies E2007-A001-207,~     E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time~     perampanel tablets become commercially available for the treatment of Partial Onset Seizures~     (POS) in the country in which they reside. This EAP will consist of 2 phases:~        -  Screening: The patient will start the program once the Screening assessments are~          completed and the patient is qualified for participation.~        -  Treatment: Additional assessments, physical examinations, and dosage changes will be~          clinically determined by the treating physician.~      Patients will enter this program on the same dose of perampanel that they were receiving at~     the end of their participation in previous study. Doses of perampanel and of concomitant~     anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based~     on clinical judgment.~      Treatment will be prescribed as long as clinically appropriate according to the judgement of~     the treating physician and the approved Summary of Product Characteristics (SmPC).~      The program will complete in a staggered fashion, country by country, as and when perampanel~     becomes commercially available for the treatment of POS in each country.~   "
90610|NCT01871220|"~     The purpose of this study is to compare the effect of two different implant abutment designs~     on gum tissue volume changes over time after implant placement.~   "
90611|NCT01871207|"~     Some studies have recently shown that the concentration of erythropoietin in the vitreous~     humor of diabetic patients suffering from diabetic retinopathy is higher than non-diabetic~     patients. It was reported a higher concentration of erythropoietin in vitreous humor than~     blood, indicating a local production. In some cases it was also found a positive association~     between concentrations of Erythropoietin and Vascular Endothelial Growth Factor (VEGF). Both~     of these factors, erythropoietin and VEGF, show important angiogenic activity and may play a~     role in the development of diabetic retinopathy.~      This study enrolled type 2 diabetic patients with PDR who had to undergo vitrectomy during~     the period May 2011-January 2012 at the Unit of Ophthalmology, A.O. Civil Hospital and~     University of Brescia. Inclusion criteria were the following: type 2 diabetes, age greater~     than 18 years, and PDR; exclusion criteria were: age less than 18 years, type 1 diabetes,~     initial DR, PDR patients not requiring surgery, previous vitrectomy in the eye under~     examination or other ophthalmic surgery or laser therapy within the previous 3 months.~      Non-diabetic patients who underwent vitrectomy for macular hole or pucker represented the~     control group (CTRLs); their inclusion criteria were: age greater than 18 years and the~     presence of macular pucker or macular hole requiring vitrectomy. Exclusion criteria were:~     age less than 18 years, diagnosis of diabetes mellitus, and previous vitrectomy in the eye~     under examination or other ophthalmic surgery or laser therapy within the previous 3 months.~     All patients underwent a complete ophthalmologic examination (visual acuity, slit lamp,~     tonometry, fluorescein retinal angiography, and optical coherence tomography -OCT-).~     Informed consent was obtained from all patients after a detailed description of the aims and~     procedures of the study.~      The following data were recorded for each patient:~        1. Population: age (years), sex (M/F);~        2. Clinical: diabetes (Absent or Type 2); time since initial diagnosis of diabetes~          (years); type of therapy for DM: diet, oral hypoglycaemic agents, mixed (oral agents~          and insulin, insulin); hypertension (defined as systolic blood pressure > 140 and~          diastolic blood pressure > 90 mmHg or on antihypertensive drugs); current (Yes/No)~          antihypertensive therapy; use of angiotensin II receptor blockers (ARB) or angiotensin~          converting enzyme inhibitors (ACE-i); presence of hypercholesterolaemia, comorbidities,~          therapy with statins (Yes/No), anticoagulants (Yes/No), antiplatelet therapy (Yes/No);~          other therapies performed, smoking (non-smoker, active smoker); complications of~          diabetes mellitus present at the time of evaluation (heart disease, nephropathy,~          neuropathy);~        3. Ocular: eye (OD/OS); visual acuity; presence and grade of diabetic retinopathy;~          presence of emovitreo; presence of diabetic macular oedema; presence of cataract or~          lens implant; intervention with phacoemulsification during vitrectomy; presence of~          retinal diseases, or any other concomitant eye diseases; performance of previous~          retinal laser therapy, intravitreal injection of Avastin before the vitrectomy;~        4. Biochemical: Haemoglobin (g/dL); glucose (mg/dL); glycated haemoglobin (%); platelets~          (N/mmc); creatinine (mg/dL); albuminuria (mg/day), creatinine clearance (mL/min),~          calculated by the Modification of Diet in Renal Disease (MDRD) formula; total~          cholesterol (mg/dL); HDL and LDL; triglycerides (mg/dL).~      All patients underwent a 23- or 25-gauge pars plana vitrectomy. The primary outcome of the~     study was the measurement of EPO and VEGF concentrations in serum and vitreous and aqueous~     humor. Blood samples, taken before surgery, were centrifuged at 3000 rpm for 10 minutes to~     separate the serum fraction, which was stored at -80°C. Aqueous and vitreous humor were~     taken during the surgery and immediately frozen at -80°C. Both EPO and VEGF concentrations~     were measured in serum and vitreous humor; however, owing to the small amount of sample,~     only EPO concentrations were determined in aqueous humor. EPO was assayed by~     radioimmunoassay (Immulite EPO 200, Siemens), with the lowest detection limit of 1.0 mIU/mL.~     VEGF was assayed by ELISA (Human VEGF Immunoassay, R & D Systems Europe, Abingdon, UK) with~     a lower limit of detection of 10.0 pg/mL. VEGF concentrations below the lower limit of~     detection were set to 5 pg/mL to perform statistical analysis. VEGF values above 2000 pg/mL~     were set to 2500 pg/mL; statistical tests were also performed after deleting the data above~     2000 pg/mL.~   "
90612|NCT01871194|"~     This study aims to evaluate the use of rivaroxaban and its short term safety when used by~     patients for the new indications of prevention of stroke and systemic embolism in patients~     with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary~     embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their~     care team on rivaroxaban or an alternative anticoagulant for the specified indications~     during the study period will be eligible to take part. A questionnaire will be completed by~     the care team of each patient at the start of treatment and again 12 weeks later. The care~     team will complete the questionnaires using information from the patient's medical notes,~     not by asking the patient directly. If a participant has an adverse event during the 12 week~     period, we may ask the patient's care team to fill out a further follow up questionnaire. No~     other examinations or tests will be performed. Patients will only be recruited to the study~     after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has~     been made, so that prescribing behaviour is not altered by the study. It is an~     observational, non-interventional study covering the whole of England and Wales.~   "
90613|NCT01871181|"~     Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve~     loss of sensation during surgery and satisfactory pain control afterwards. Many studies have~     shown that nerve block is associated with higher degree of success in controlling pain after~     open inguinal hernia repair. Nerve block can be administered by a single injection with a~     long acting local anesthetic agent using ultrasound guidance. This study is to compare~     different techniques for freezing the nerves responsible for pain after open inguinal hernia~     repair. Patients will be randomized to one of two groups. In the first group, participants~     will receive ultrasound-guided nerve block following induction of general anesthesia but~     prior to surgical procedure. In the second group, participants will receive local anesthetic~     injection directly into the wound by the surgeon prior to closure. The investigators will~     assess the level of pain control for 48 hours after the surgical procedure. Patients will be~     provided with additional medications for pain relief if necessary. The investigators will~     also contact participants to follow-up with regard to possible chronic groin pain after 3~     months following the surgical procedure.~   "
90614|NCT01871168|"~     The purpose of this study is to establish an alternative method of postoperative pain~     control to the current standard of practice, patient-controlled analgesia with intravenous~     opioids, for patients undergoing a major major abdominal surgery at the University of~     Alberta Hospital. The primary objective is to determine whether a continuous transversus~     abdominis plane (TAP) block, run until the third postoperative day, will reduce the amount~     of intravenous morphine required. Additionally, the investigators propose to measure the~     amount of local anesthetic (lidocaine) in the blood during this time frame to provide~     patient safety data for this procedure. This will be a prospective controlled randomized~     double-blind clinical trial. The patients, anesthesiologists and staff providing post~     operative care will be blinded to group assignment. Patients will be randomized by sealed~     envelopes.~   "
90615|NCT01871155|"~     The purpose of this study is to determine whether a novel edible nutritious gel for patients~     with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality~     of life of head and neck cancer patients while undergoing conventional radiotherapy.~   "
90616|NCT01871142|"~     In low oxygen environments, such as high-altitude, some adults may become ill and suffer~     from acute mountain sickness. Further, all adults will find that exercising becomes much~     more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose~     of this investigation is to study the effects of a new medicine called Aes-103. A company~     called AesRx, LLC makes this medicine. The active ingredient in the medicine is~     5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in~     coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The~     investigators believe that Aes-103 may help people adjust to high-altitude quickly and~     prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will~     promote endurance performance in low oxygen environments in healthy adult humans.~      Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the~     National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential~     anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems~     in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood~     cells carry more oxygen. It is for this reason that the investigators in this study believe~     Aes-103 might help people adjust to high-altitude quickly.~      There are no known special safety considerations with the active ingredient in Aes-103~     (5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single~     doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the~     toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and~     chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single~     doses of Aes-103 are expected to have no significant negative/toxicological effect at the~     doses being evaluated in this study.~   "
90883|NCT01867632|"~     The goal of the present study is to definitely determine whether the use of acellular dermal~     matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation.~     Although individual studies have described promising advantages to its use in cleft palate~     surgery, no consensus currently exists. Without concrete evidence, one must question the~     whether the increased cost, time and potential patient risk (human derived tissue) to~     patients justifies its use in primary cleft palate repair.~   "
90617|NCT01871129|"~     The postoperative removal of intubation tube induces a noticeable sympathic response and~     increase of blood pressure. The risk of complications is especially elevated with the~     patients having cardiac surgery. Though sedation inhibits the sympathetic responses to~     extubation, according to the current protocol the propofol infusion has to be discontinued~     well before extubation because of its inhibitory effects on breathing centers.~      Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its~     characteristic that it does not have the paralyzing effect on breathing. The aim of our~     study is to work out whether dexmedetomidine-extended propofol sedation over the extubation~     diminishes the aforementioned harmful effects of the extubation procedure.~      Study design is prospective double-blinded randomized study. The investigators compare two~     groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic~     valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first~     group receives dexmedetomidine infusion and the other receives placebo infusion after the~     end of propofol infusion.~      The specific goal of the study is to figure what haemodynamic - mostly blood pressure~     related - changes can be observed when the postoperatively cut propofol infusion is~     continued with dexmedetomidine over the extubation procedure.~      Our hypothesis is that by using dexmedetomidine supplemented sedation the normally~     notifiable peak in blood pressure may be avoided.~      The study will be carried out completely in Cardiac ICU in Tampere University Hospital.~   "
90618|NCT01871116|"~     This research is being done to assess the effectiveness of a weight loss program in women~     with early stage breast cancer whose body mass index (BMI) is in the overweight or obese~     range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall~     health, but may also decrease the chance of breast cancer coming back. A weight loss~     counseling program was studied in a general population and was found to be effective to help~     reduce weight over a 2 year period.~      The main goal of this study is to determine if women with a recent diagnosis of early breast~     cancer will also lose weight with this program. To better understand the effect that weight~     loss has on women with breast cancer, we will compare the patterns in blood and breast~     tissue samples (tissue biopsies will be optional), and questionnaires evaluating different~     aspects of one's well-being, before and after a dietary intervention or no intervention.~   "
90619|NCT01871103|"~     Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a~     reliable flap donor site in reconstructive hand surgery because of its similar quality to~     the original. The dorsal homodigital island flap can be used as a reliable alternative for~     reconstructing small to moderate defects of the fingers. In this retrospective study, the~     investigators would evaluate the efficacy of the technique for tissue reconstruction in~     different regions of the finger, with an emphasis on sensibility, pain and donor site~     morbidity.~   "
90620|NCT01871090|"~     A prospective, post market, non-randomized study to evaluate the reduction in time to~     interrogation for patients with St. Jude Medical remote care compatible devices interrogated~     by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will~     enroll up to 100 patients total.~      Expected duration of the study is 6 months. Once enrolled the patient will participate in~     the study for the duration of the Emergency Department stay, until discharged or admitted to~     the hospital.~   "
90621|NCT01871077|"~     The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution~     PRO-156 over the ocular surface of ophthalmologically healthy volunteers~   "
90622|NCT01871064|"~     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios~     at tracheal extubation when anesthesiologists have determined that full recovery of~     neuromuscular function has occurred using standard clinical criteria for participants whose~     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase~     inhibitor administered as per standard routine care.~   "
90623|NCT01871051|"~     This project was aimed to identify the risk factors associated with the occurrence of~     respiratory complications in post anesthesia care unit. The primary outcome was the~     composite measure of occurrence of complications in PACU. The components were apnea or~     hypopnea, laryngospasm, bronchospasm and prolonged oxygen requirement.~   "
90624|NCT01871038|"~     To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted~     at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and~     the Medical University of South Carolina (MUSC) in Charleston, South Carolina.~      Children born on or after April 1, 2006 presenting to CCHMC as an inpatient or for a~     short-stay or Emergency Department (ED) visit with acute gastroenteritis (AGE) and/or fever~     will be approached for enrollment. Children will be eligible if they have vomiting and/or~     diarrhea less than or equal to 10 days duration. Data including demographic information,~     illness characteristics and socio-economic status will be collected from each patient. A~     sample of the patient's stool will be collected within 14 days of the onset of symptoms.~     Stool specimens will be tested for rotavirus antigen by Rotaclone at CCHMC. All rotavirus~     positive stool specimens will be typed for common G and P serotypes. Using the children~     identified with rotavirus as our cases and the children who were rotavirus negative as our~     controls, we will conduct a case control study to assess the effectiveness of rotavirus~     vaccines, in particular Rotarix.~   "
90625|NCT01871025|"~     To study the effects of early exercise training in hospitalized patients for Chronic~     Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one~     group, early exercise training (aerobic and strength) during hospitalization for COPD~     exacerbation followed by exercise training at home until 90 days to discharge and in the~     other the intervention is usual care. In both group, usual respiratory physiotherapy~     techniques during hospitalization and adequate physical activity recommendations have been~     included. The main variable is the presence of a new COPD exacerbation according to Global~     Initiative for COPD (GOLD guidelines) with a minimum of 12 months-follow up.~   "
90818|NCT01868477|"~     The primary purpose of this trial is to assess the effect of treatment with deferasirox~     combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with~     low- and int-1-risk myelodysplastic syndrome.~      The addition of deferasirox to erythropoietin could lead to a potential synergism with the~     reduction of reactive oxygen species, through both the NF-kB pathway and the control of free~     toxic iron. This may create a better environment in the bone marrow for a better response~     with erythropoietin.~      This study is designed to test in a prospective way the combination of deferasirox with~     erythropoietin in term of their effect on hematopoiesis.~   "
90626|NCT01871012|"~     Total Knee Replacement (TKR) performed under general anesthesia is a common successful~     orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this~     procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike.~     Many diabetic patients have clinical or subclinical neuropathy. Although there is no~     evidence that the neuropathy is exacerbated by neural blockade, recent studies have~     suggested that the peripheral nerves in diabetic patients may be more susceptible to trauma~     and local anaesthetic toxicity. Therefore, The investigators observe peripheral nerve blocks~     with ropivacaine on diabetic patients or non-diabetic patients undergoing TKR by assessing~     the management of intraoperation and the Postoperative Recovery and complications.~   "
90627|NCT01870999|"~     This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of~     aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with~     schizophrenia.~   "
90628|NCT01870986|"~     This healthy volunteers study will evaluate 210 subjects who will receive a single~     sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European~     Union). This study will involve sampling and pharmacokinetics evaluation of drug levels~     following administration of PF-06410293 and the licensed adalimumab products.~   "
90629|NCT01870973|"~     The purpose of this study is to evaluate patients with emergency pain and a sore (infected)~     tooth to determine if immediate root canal therapy is better at reducing pain, when compared~     to initial treatment with antibiotic and pain medication followed by root canal therapy.~     Each participant will be randomly assigned a number, which will determine if they will~     receive initial endodontic treatment that day or at a later date. Each participant will~     receive an anesthetic injection, pain medication and a prescription for an antibiotic. They~     will be asked to keep a diary to record their pain level after the injection and their pain~     levels and the amount and type of pain medication taken each day for the next 5 days.~     Participants who did not receive root canal therapy at the initial appointment will receive~     it after the 5 day postoperative period. The pain levels and medication use will be compared~     between the treatment and nontreatment groups.~   "
90630|NCT01870960|"~     The main problem of using xenogenic bone in sinus floor elevation is the slow rate of~     absorption, which gives the percentages of vital bone low (20 to 30% depending on the study)~     in which the dental implant will be positioned However, osseointegration of the implant can~     be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and~     osteogenic properties known, could promote bone healing during surgery sinus floor elevation~     by increasing the percentage of vital bone reformed, when added to xenografts.~   "
90631|NCT01870947|"~     This is an assisted exercise trial involving exercise on a stationary bike, brain imaging~     and DNA(genetics)sampling. The purpose of this study is to find out if performing a~     progressive, supervised assisted exercise program on a stationary bike improves quality of~     life, increases motivation to continue to exercise, improves dietary behavior and leads to~     sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires~     will be used to assess exercise motivation and dietary behavior. Brain's responses to~     different visual images will also be assessed.~   "
90632|NCT01870934|"~     Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet~     (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers;~     approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer~     treatment is extensive, resource demanding and highly specialized and necessitates~     involvement of patient, hospital and local in-home care personnel.~      The 3D photo optic camera project aims at a much more efficient and precise method for~     diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for~     LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera~     that takes pictures and measurements of the ulcer that can provide the basis for correct~     diagnosis and treatment of the ulcer. The camera was developed in close cooperation with~     TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.~   "
90633|NCT01870921|"~     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the~     incidence of major cardiovascular events of ticagrelor in Chinese patients with acute~     coronary syndrome~   "
90634|NCT01870908|"~     This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and~     biological agents.~   "
90635|NCT01870895|"~     To demonstrate the superiority of YM060 to a placebo in global assessment of relief of~     overall IBS symptoms and stool form normalization, and to evaluate safety in female patients~     with diarrhea-predominant irritable bowel syndrome (D-IBS).~   "
90636|NCT01870882|"~     The purpose of this study is to determine the feasibility and preliminary efficacy of~     attention training using a portable electronic device for opioid-dependent cocaine-users~     stabilized on methadone.~   "
90637|NCT01870856|"~     The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper~     epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of~     that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the~     ocular surface during blinking.~   "
90638|NCT01870843|"~     The purpose of this study is to evaluate the impact of escitalopram on quality of life and~     social functionality in patients with major depressive disorder with anxiety symptom.~   "
90639|NCT01870830|"~     The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients~     with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate~     altitude.~   "
90741|NCT01869504|"~     Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an~     essential tool in Chest Medicine. A common complication of drain insertion is accidental~     removal of the drain, usually as a result of inadequate securing techniques, with rates of~     up to 1 in 5 reported. This often results in the need for further procedures (including~     drain re-siting), with associated additional risk to the patient and an increase in health~     care costs. One suggested method to reduce premature drain removal is to use chest drains~     with ballooned tips, much like a bladder catheter. These would provide a physical~     obstruction inside the chest cavity at the insertion site, whilst being easy to use as~     stitching or extensive taping may not be required.~      The investigators propose a trial of a dedicated ballooned chest drain to investigate~     whether a reduction in drain re-siting rates can be achieved. Pain scores will also be~     assessed during this trial to ensure that irritation of the lining of the lung or chest wall~     by the balloon is not excessive.~   "
90640|NCT01870817|"~     After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely~     fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in~     hospital. Current practice is to stop feeding once the patient leaves hospital, although the~     tube is left in place for the first 6 weeks. Most patients lose weight after surgery and~     have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ~     feed restarted because of nutritional problems and this requires a further inpatient stay.~      It is unknown whether every patient would benefit from this type of feeding at home.~     Previous studies have only assessed the value of JEJ feeding while patients are still in~     hospital. There is little known about the benefit of continuing JEJ feeding after discharge~     from hospital, although home feeding is not uncommon in other patient groups (eg. after a~     stroke).~      The proposed study will provide initial information on patients' well being by measuring~     quality of life and factors such as change in body weight and dietary intake following a~     period of home JEJ feeding after surgery. Subjects recruited into the study will be placed,~     randomly, into a control group who receive current nutritional care (based on dietary advice~     and oral nutritional supplement drinks) or an intervention group who will receive home JEJ~     feeding for 6 weeks after hospital discharge, in addition to current treatment.~      If subjects in the control group are experiencing problems eating at home, home feeding~     through the JEJ tube will be started as needed.~      The study will also examine how surgery and JEJ feeding at home impact on the patient and~     carer(s) by means of questionnaires and interviews conducted in the patients' home.~      Information obtained will assist in the design of a multicentre study. This intervention is~     considered important because it has the potential to benefit thousands of patients each year~     at a modest cost.~   "
90641|NCT01870804|"~     The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin~     and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in~     patients with non-ST-elevation acute coronary syndromes scheduled for early invasive~     strategy.~   "
90642|NCT01870791|"~     The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately~     16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy~     regimens, the average survival for these patients is around 9 months from diagnosis.~      Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish~     oil supplementation can improve general well-being and quality of life in patients receiving~     palliative chemotherapy for a number of different cancer types. It has also been suggested~     that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy.~      This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the~     most widely used regimen for patients with advanced oesophago-gastric cancer, will make this~     drug regimen more effective at killing oesophago-gastric cancer cells, such that disease~     progression is delayed. Forty-five patients who have been diagnosed with advanced~     oesophago-gastric cancer will be recruited over a two year period to receive standard~     chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be~     compared to a matched historical control group of patients who have received identical~     chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently~     effective, tolerable and feasible then it will be the intention of the trial team to take~     the combination forward to treat patients with advanced oesophago-gastric cancer in a~     randomised study.~   "
90643|NCT01870778|"~     The purpose of the study to evaluate the efficacy, safety and tolerability of intravenous~     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF)~     patients.~   "
90644|NCT01870765|"~     Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia.~     Especially patients with acute or chronic pulmonary diseases are at risk of respiratory~     failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be~     performed safely using non-invasive ventilation. It seems probable that high-flow oxygen,~     which is used in the treatment of patients with hypoxemic respiratory failure, is equally~     effective in preventing the development of respiratory failure during fiberoptic~     bronchoscopy while improving patient comfort. In this prospective randomised study the~     safety of high-flow oxygen is compared with non-invasive ventilation in patients with~     hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.~   "
90645|NCT01870752|"~     Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility.~     Ovarian tissue cryopreservation is an experimental strategy offered at The University of~     Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this~     study is to determine the efficacy and safety of autologous transplantation of previously~     cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian~     insufficiency after cancer treatments.~   "
90646|NCT01870739|"~     This was the first evaluation of the effects of LCZ696 on local and regional measures of~     aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure.~     The results of this exploratory study will help to understand the mechanism of action of~     LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with~     cardiovascular diseases.~   "
90647|NCT01870726|"~     The study will assess the safety and the dose of the combination of INC280 and buparlisib~     (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent~     glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In~     addition, the anti-tumor activity of INC280 single agent will be assessed in patients with~     recurrent glioblastoma with c-Met alteration.~   "
90648|NCT01870713|"~     The purpose of this study is to reveal the key proteins involved in gastric bypassing~     surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate~     standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2~     diabetes mellitus patients in China.~   "
90649|NCT01870700|"~     A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri~     in adult patients with functional constipation.~   "
90650|NCT01870687|"~     The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg)~     VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre~     menstrual syndrome).~   "
90651|NCT01870674|"~     Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of~     YH12852 after oral administration in healthy subjects~   "
90652|NCT01870661|"~     Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the~     short axis technique. Our hypothesis is that long axis ultrasound placement will increase~     the longevity of the IV catheter.~   "
90653|NCT01870648|"~     The primary objective is to determine if the administration of a single dose of oral~     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in~     intravenous (IV) rehydration therapy in children presenting for emergency department care~     with some dehydration, vomiting and diarrhea in Pakistan.~      SOME Dehydration is defined as 2 or more of the following signs and symptoms:~        -  Restlessness, irritability~        -  Sunken Eyes~        -  Drinks eagerly, thirsty~        -  Skin pinch goes back slowly~   "
90655|NCT01870622|"~     Most premature babies have difficulty breathing at birth and need help (resuscitation). The~     treatment for this is to gently inflate their lungs with a resuscitation device and a~     facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in~     the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical~     team checks if the breathing tube is correctly placed within the windpipe. The investigators~     routinely use a detector which checks for exhaled carbon dioxide or the graphical display of~     waves forms of the infants breathing to check that the breathing tube position. However, the~     investigators do not know which one (exhaled carbon dioxide or the graphical display of~     waves forms) is better to check that the breathing tube position is correct and therefore~     the investigators would like to study them. The purpose of this study is to compare exhaled~     carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves~     group) to provide us with information on how the investigators can help babies who struggle~     with breathing at birth.~   "
90656|NCT01870609|"~     This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of~     defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not~     progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment~     with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the~     study, each subject must have tumor Merlin status(high or low) established by~     immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1~     ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will~     be stratified by tumor Merlin status (high versus low). Progression will be assessed both~     locally and by central review using the Response Evaluation Criteria In Solid Tumors~     (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression~     or other discontinuation criteria are met. Following documentation of nonfatal disease~     progression, all subjects will be followed for overall survival by telephone contact every 2~     months until end of life or the close of the study.~   "
90657|NCT01870596|"~     This randomized phase II trial studies how well cytarabine with or without SCH 900776 works~     in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy,~     such as cytarabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.~   "
90658|NCT01870583|"~     In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation~     solutions for best outcome of surgical site infection. The three different solutions are:~     Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin~     preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine~     based skin preparation solutions. Women are prospectively randomized to one of the three~     groups and followed until thier postpartum visit at 6-8 weeks following delivery.~   "
90659|NCT01870570|"~     The purpose of this study is to determine and compare the glycaemic index values and~     response parameters of 6 food products between 3 laboratories.~   "
90660|NCT01870557|"~     Objective To collate the bone status in type 1 and type 2 diabetics using biochemical~     markers and bone scans.~      Methods:~      This is a multicenter trial involving the University Hospitals of three major danish cities:~     Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of~     examinations including:~        -  Blood samples to analyze bone markers, glycemic state, kidney function and~          sex-hormones.~        -  24 hour urine sample to analyze bone markers and kidney function.~        -  Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution~          peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density,~          t-score and bone structure.~      Participants:~      100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg,~     Aarhus and Odense, general practitioners and flyers.~   "
90661|NCT01870544|"~     The purpose of the weight-loss study is to characterize the effect of LGG supplementation on~     the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass~     and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota~     pattern and the degree of weight-loss post-surgery.~      The investigators hypothesize that LGG administration will result in a leaner pattern of~     gut microbiota that will lead to higher weight loss at 3 months post-surgery.~   "
90662|NCT01870531|"~     This study is to determine the clinical and neuroimaging characteristics of Transient~     Ischemic Attacks in Korean populations.~   "
90663|NCT01870518|"~     Purpose: This is a prospective single-center, randomized, patient and evaluator-blind~     clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi)~     versus subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD)~     patients with mild cognitive impairment (MCI).~   "
90664|NCT01870505|"~     The purpose of this study is to test the safety of a drug called BYL719 at different dose~     levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the~     patient and breast cancer. BYL719 will be given with either letrozole or exemestane to~     patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase~     II dose of BYL719 in combination with letrozole or exemestane has been determined in the~     dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion~     phase of the study. The purpose of the expansion phase is to further define the safety and~     feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase~     II dose, and to estimate efficacy.~   "
90742|NCT01869491|"~     This study is being conducted to provide evidence that Compound Sodium Alginate Double~     Action Chewable Tablets are effective in managing the symptoms of heartburn, acid~     regurgitation and dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).~   "
90831|NCT01868308|"~     Our objective is to investigate the predictive value of a panel of biomarkers associated~     with two biologically plausible pathways of preterm birth: membrane breakdown and cervical~     remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin,~     and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a~     prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm~     birth in an effort to better risk stratify this cohort.~   "
90665|NCT01870492|"~     Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural~     hospitals, do not have the infrastructure or medical support to effectively treat AIS~     patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or~     emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several~     studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported~     low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not~     receive proper treatment according to established guidelines. Thus, there remains an~     increasing need to assess and address the barriers that prevent patient access to proper AIS~     treatment.~      Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the~     diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To~     date, there have been no statewide studies initiated in Wisconsin to assess the regional~     barriers to the treatment of AIS patients with thrombolytic or endovascular therapy, and~     many hospitals do not routinely collect and analyze AIS patient data.~      The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage~     community hospitals statewide to identify the regional barriers to AIS therapy in WI.~   "
90666|NCT01870479|"~     Main purpose: To determine if live music moderates the level of chemotherapy related~     anxiety, in patients with haematological cancer~      The investigators hypothesize that live music:~        1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy~          treatment~        2. May counteract the patients feeling of loss of identity and alienation in this~          particular group of cancer patients.~        3. Is more effective in patients with good musical abilities.~        4. Is more effective than taped music.~      Method: Intervention groups:~        1. Listening to patient-preferred live music during chemotherapy~        2. Listening to patient-preferred taped music during chemotherapy~        3. Standard care~      Endpoints:~      Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.~      Background: In order to establish the intervention procedures, the investigators have~     carried out a pilot study at the hematology department at Hospital of Southwest Denmark,~     including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot~     results indicates that live music has an uplifting, pain relieving, and then releasing~     effect and that music has a positive impact on hospitalisation. According to the evaluation~     forms filled out by 243 cancer patients, the music experience has provided human~     anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy~     involves major physical and psychological problems. Not much has been provided in the~     clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A~     review of the literature illustrate the need for developing new potential areas of~     intervention that takes into account, that not only do cancer patients face challenges in~     everyday life ranging from physiological changes over social to psychological problems, but~     also during treatment procedures, which may cause a higher level of anxiety associated with~     these procedures, e.g., chemotherapy infusion.This project investigates to what degree live~     music may relieve some of these symptoms during treatment for haematological cancer. The~     project is created in order to both measure psychosocial effects as well as direct stress~     measures, i.e. serum catecholamine. These physiological changes are measured in order to~     shed light on the mechanism behind the potential effects of live music on discomfort in~     connection with chemotherapy treatment.~      Perspectives: The vision of the project focus on strengthening the cancer patients' ability~     to cope with physiological and psychological issues during chemotherapy sessions and to make~     the patients conscious of music as an option in these coping efforts. Hopefully, the results~     will provide a scientific basis for an evaluation of the perspectives and the potentials of~     live music treatment during chemotherapy infusion among cancer patients.~   "
90667|NCT01870466|"~     The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol~     and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in~     healthy male subjects.~   "
90668|NCT01870453|"~     The objective of the study is to determine the effects of different anesthetic agents on~     cognitive function in patients with Alzheimer's disease (AD). The investigators will test~     the hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or~     sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients~     with AD.~   "
90669|NCT01870440|"~     The purpose of this study is to determine whether an intravitreal dexamethasone implant~     (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious~     uveitis.~   "
90670|NCT01870427|"~     The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection~     (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF~     agents.~   "
90671|NCT01870414|"~     The influence of cryotherapy on ankle motor control and balance of athletes is~     controversial. The aim of this study is to assess the neuromuscular response of the dominant~     leg and body balance basketball athletes after application of cryotherapy. The sample is~     distributed into two groups. Group one will consist of 20 basketball players without a~     history of ankle sprains in the past 12 months and no complaints of instability in this~     joint, and group two, 20 non-athletes, active, no complaints in the lower limb in the last~     12 months. Will perform the inversion movements and single-leg hop for the analysis of the~     electromyographic signal of anterior tibial, peroneal, gastrocnemius (lateral), rectus~     femoris, hamstrings and gluteus medius. Will also be performed kinematic analysis in search~     of body balance and range of motion of the joints of the lower limbs. And yet, the analysis~     of the plantar support and ground reaction force. After the initial collection of the data~     subjects will be submitted to the application of cryotherapy by immersion in a time of 20~     minutes, with a temperature of 6 ± 2 degrees Celsius. Data collection will be held in pre,~     0, 10, 20 and 30 minutes after application of cryotherapy. The data will be statistically~     analyzed to compare the results in collection times within and between groups. The~     significance level is set at 5%. The data support the intended use of cryotherapy in motor~     control of the inversion movement, jump and balance of athletes.~   "
90672|NCT01870401|"~     To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of~     stenosis or occlusion of native below-the-knee arteries.~   "
90673|NCT01870388|"~     The main purpose of this study is to measure how much of the study drug called baricitinib~     gets into the blood stream and how long it takes the body to get rid of it. Healthy~     participants and those with liver disease may enroll. The study will last about 7 days for~     each participant, not including screening.~   "
90674|NCT01870375|"~     Neurobehavioral function and quality of life are compromised in many patients with~     mucopolysaccharidosis (MPS) disorders. The long-term goals of this research are to: 1) more~     accurately inform patients/parents regarding potential neurobehavioral outcomes; 2) develop~     sensitive measures of disease progression and central nervous system (CNS) treatment~     outcome; and 3) help clinical researchers develop direct treatments for specific brain~     structures/functions. The investigators hypothesize that specific and localized neuroimaging~     and neuropsychological findings and their relationship will be distinct for each MPS~     disorder. It is further hypothesized that without treatment, functions will decline and~     structure will change over time in a predictable fashion, and will be related to locus of~     abnormality and stage of disease.~   "
90860|NCT01867931|"~     The purpose of this study is to characterize and compare epithelial damage in patients with~     erosive esophagitis and non-erosive reflux disease.~   "
90675|NCT01870362|"~     Periodontal disease is a major cause of tooth loss in humans and is one of the most~     prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva~     becomes inflamed leading, in some cases, to the destruction of the alveolar bone.~     Periodontitis has two distinct but interconnected etiologic components, periodontopathic~     bacteria and host-mediated connective tissue-destructive responses to the causative bacteria~     and their metabolic products.~      A few studies have revealed that probiotic Lactobacillus strains were useful in reducing~     gingival inflammation and the number of black-pigmented rods, including Porphyromonas~     gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions,~     its shown that application of beneficial bacteria, as an adjunct to scaling and root planing~     (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding~     on probing.~      The aim of the present study is to evaluate the improvement of periodontal health with~     probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].~   "
90676|NCT01870349|"~     The purpose of this study is to determine whether there are differences in inflammatory~     markers and bone-mediator protein expression in the fluid surrounding implant abutments~     manufactured with either titanium or zirconium.~   "
90677|NCT01870336|"~     The purpose of this study is to evaluate the immediate and short-term effects of the~     combination of lateral customized foot orthoses on the pain and medial knee loading during~     gait among medial knee osteoarthritis patients. The effects of the combination is compared~     to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They~     have to wear each of treatments (foot orthoses, knee brace and combination) during three~     months. A fifteen days wash-out period is given after each three months. Biomechanical~     evaluation is carried out before and after each three months. This evaluation consisted of~     three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster~     Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36(~     MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During~     motion analysis, ten gait trials are executed without treatment and ten with the treatment.~   "
90678|NCT01870323|"~     In an effort to address the physical inactivity crisis among adolescents, the present study~     will examine the efficacy of using an already established Web-based social networking~     platform (i.e., Facebook) to deliver a physical activity intervention to adolescents.~   "
90679|NCT01870310|"~     It is a randomized prospective controlled study evaluating the effect of transcatheter renal~     denervation on the clinical status of patients with chronic heart failure and its safety~     procedures. The working hypothesis of the study is that by performing transcatheter renal~     denervation in patients with chronic heart failure and severe left ventricular systolic~     dysfunction there will a resultant reduction in the renal sympathetic activation which in~     turn will reduce the number of hospitalizations and deaths from heart failure.~   "
90680|NCT01870297|"~     The main purpose of this study is to assess the safety and tolerability of LY3025876 given~     alone (Part A) and in combination with liraglutide (Part B) in participants with type 2~     diabetes mellitus (T2DM).~   "
90681|NCT01870284|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo~     in participants with active AS.~   "
90682|NCT01870271|"~     The aim of this pilot study is to evaluate the developmentally adapted cognitive processing~     therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA)~     related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering~     from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior~     to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician~     Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI),~     Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).~   "
90683|NCT01870258|"~     prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks~   "
90684|NCT01870245|"~     This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to~     assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take~     place in the US at one clinical site.~   "
90685|NCT01870232|"~     Dental anesthesia is routinely performed based on anatomical landmarks which can be variable~     leading to repeated injections and failure. Ultrasonography can be used to guide these~     injections by identifying the nerves, accompanying blood vessels and the bony landmarks. 20~     healthy adult patients will be selected to receive ultrasound guided greater palatine nerve~     block (gpn) (10 patients) or inferior alveolar nerve (ian) block (10 patients) depending on~     the dental procedure they are undergoing. The study will evaluate the feasibility and~     success rates of the ultrasound guided gpn and ian nerve block.~   "
90686|NCT01870219|"~     The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and~     Tp-e interval during in patients with major depression.~   "
90687|NCT01870206|"~     Polio is a highly infectious disease caused by a virus. It invades the nervous system, and~     can cause total paralysis in a matter of hours. The virus enters the body through the mouth~     and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting,~     stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible~     paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing~     muscles become immobilized. There is no cure for polio, it can only be prevented. Polio~     vaccine, given multiple times, can protect a child for life.~      Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex~     compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.~   "
90743|NCT01869478|"~     This pilot trial will be the first step toward direct comparison of delivery of endovascular~     reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a~     time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A~     randomized trial is justified for the following reasons: 1) The high rate of death and~     disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates~     critical analysis of alternate therapies with therapeutic potential, 2) endovascular~     treatment for acute ischemic stroke is expanding in North America without compelling~     evidence of safety and efficacy from well-designed clinical trials, 3) critical~     cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from~     controlled studies.~   "
90688|NCT01870193|"~     Glutathione is an important antioxidant protein which protects cells from harmful oxidative~     stress. Elderly humans are known to have elevated oxidative stress and deficiency of~     glutathione, but it is not known whether there is deficient synthesis of glutathione in~     muscle tissue of elderly humans.~      Mitochondria are engines of cells where food consumed is burned to make energy. Under normal~     conditions the fuel of choice in the fasted state is fat, but fasted elderly humans are not~     able to oxidize fat as well as healthy young humans. Elderly humans also have the highest~     incidence and prevalence of being overweight and obese, and have increased storage of fat in~     liver and muscle.~      This study will help determine whether~        1. elderly humans have diminished synthesis of glutathione in the skeletal muscle, and~          whether this can be improved by supplementing cysteine and glycine (and not an~          isonitrogenous placebo) in the diet;~        2. improving muscle glutathione concentrations can also improve fuel oxidation in aging;~        3. improvement of intracellular glutathione concentrations will be associated with a~          change in total body fat content~   "
90689|NCT01870180|"~     Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from~     meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain~     a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye~     symptoms. Treatments often involve gently warming the eyelids to melt this blockage which~     prevents tears from spreading over the eye. Although there has been some research on~     application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and~     more effective method of applying heat to the eyelids. This study will test the efficiency~     of these eyelid warming devices over a period of two weeks use in one eye compared to the~     other non-treated eye.~   "
90690|NCT01870167|"~     The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can~     reduce the incidence of peristomal wound infection in the paediatric population.~   "
90691|NCT01870154|"~     Background: Burnout syndrome is an important health problem that affects many professionals~     and must be addressed globally, with both organizational measures and personal~     interventions. Burnout of health professionals can be prevented in order to avoid personal,~     familial, and social consequences, as well as repercussions for patients.~      Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized~     clinical trial in 2 parallel groups: intervention and control. All health professionals from~     7 health care centers (HCCs) will form the intervention group, and all health professionals~     from 7 different HCCs will form the control group. The intervention group will receive 16~     hours of training at their work place. The Maslach's burnout inventory (MBI), burnout~     physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item~     Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as~     measurement tools. Change in the average scores from the MBI emotional exhaustion scale will~     be compared between the intervention and control groups, measured as intention-to-treat, and~     the intervention will be considered effective if a minimum increase of 20% is achieved.~      Discussion: Due to the deleterious consequences of burnout syndrome for people suffering~     from it and for the organization where they work, it is necessary to evaluate the~     effectiveness of certain interventions for its prevention. Organizational measures are~     important for preventing burnout syndrome, but so is providing professionals with coping~     strategies, as this group intervention intends to do.~   "
90692|NCT01870141|"~     Increasing evidence suggests that psychological disorders play an important role in the~     development and worsening of type 2 diabetes (T2D). Among the spectrum of psychological~     disorders, there is a wide literature about the association between depression and T2D and~     current data show an approximately two-fold prevalence of depression in adults affected by~     diabetes compared to un-affected subjects. Moreover, depression in diabetic patients is~     associated with higher blood glucose levels, poorer adherence to therapeutic regimens~     (whether pharmacological or therapeutic lifestyle changes), more medical complications, and~     higher hospitalization rates. Nevertheless, at the best of our knowledge, the mechanism~     underlying the association between depression and adverse diabetes-related outcomes is~     currently unresolved.~      Aim of this project is to assess the efficacy of a psychological treatment for diabetic~     patients with suboptimal level of Hemoglobin A1c. This project is a RCT that seeks to~     address the question if type 2 diabetic patients with suboptimal glycaemic control would~     benefit from a specific psychological intervention, as specified below. A total of 80~     diabetic patients will be recruited and randomly assigned to two treatment arms:~        1. Standard diabetes care~        2. 24 individual sessions of psychological intervention The expected main outcome is the~          improvement of glycaemic control under psychological intervention in 38 weeks of follow~          up.~      Secondary outcomes: reduction of depression and anxiety, improvement in self-efficacy,~     perceived interference caused by diabetes, family support and eating problems.~   "
90693|NCT01870128|"~     Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid~     arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of~     various treatment regimens in early RA. Methods: This is a randomized open-labeled trial.~     Patients were randomised into three groups. In group A, patients were treated with single~     drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of~     DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C~     received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.~   "
90694|NCT01870115|"~     The investigators' long-term goal is to employ novel methods to improve bone formation and~     bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs~     and symptoms of degenerative joint and disc disease that commonly accompany bone loss as~     well as improve quality of life (QOL). These conditions generally begin silently as early as~     the menopause transition and progress to osteopenia and osteoporosis during the~     post-menopausal years in aging women. The investigators also envision this will be~     beneficial in aging andropausal men with these conditions. The investigators postulate that~     melatonin in novel combination with other natural bone-protective agents may act in a~     chronosynergy manner to prevent and correct these perturbations, reducing the risk of bone~     fractures, and lessening the stiffness and pain associated with bone, joint and cartilage~     degeneration and improving quality of life (QOL). The objective here, which is the~     investigators' next step in pursuit of our goal, is to assess the efficacy of an alternative~     therapy that uses a novel combination of bone-forming agents, melatonin, strontium~     (citrate)/ vitamin K2 (MK7), and vitamin D3 on bone health in a postmenopausal population.~     Melatonin is a novel alternative to current treatment(s) because it has multiple~     bone-protective and sleep-promoting activities within the body, and it is relatively safe so~     it can be used in an aging population without untoward side effects; strontium and vitamin~     D3 are shown to enhance bone mineralization and improve post-menopausal osteoporosis. The~     project goal is to identify if this combination therapy improves bone health and QOL~     compared to women taking placebo. The investigators' central hypothesis is that combination~     therapy using melatonin, strontium, vitamin K2, and vitamin D3 will improve bone health and~     overall QOL in postmenopausal women not taking this regimen by reducing osteoclast activity~     and increasing osteoblast activity and by improving subjective measures of stress, anxiety,~     depression and menopause-related symptoms.~   "
90696|NCT01870089|"~     Knowledge-based systems were initially developped to automatically adapt pressure support~     settings during invasive ventilation, and proved to be at least as efficient as experienced~     clinicians.~      Non-invasive ventilation has become the standard of care for patients suffering from acute~     hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in~     these patients, thus reducing their hospital mortality.~      NIV success or failure is closely related to the tolerance of NIV treatment, which is~     tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs~     during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is~     related to the use of high pressure support levels, to the presence of leaks and/or to non~     optimal expiratory trigger settings, very frequent ventilator settings adaptations should~     allow reducing patient-ventilator asynchronies but require the presence of an experienced~     clinician at the bedside during NIV treatment.~      A computer-driven ventilator settings adaptation has the adavantage of permitting very~     frequent ventilator settings adaptation whithout requiring the presence of an experienced~     clinician at the bedside and could possibly improve patient-ventilator interaction.~      The aim of the present study is to test the faisability of using the Smartcare NIV~     computer-driven system to automatically adapt ventilator settings during non invasive~     ventilation delivered because of acute respiratory failure.~   "
90697|NCT01870076|"~     Healing Touch improves measures of sleep the night prior to surgery, thus improving~     surgery-related morbidity.~   "
90698|NCT01870063|"~     Correlation between FIBTEM and intraoperative blood loss~   "
90699|NCT01870050|"~     Principal aim of this study is to assess whether a combination of topical dapsone and~     clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo~     nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily~     exploratory and essentially meant to inform the sponsor whether further development of a~     combination treatment formulation is warranted~   "
90700|NCT01870037|"~     The primary objective of this study is to evaluate the safety of a single treatment of~     hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall~     injections. Two dose levels (16000 µg and 24000 µg -20 or 30 bladder wall injections,~     respectively) in females with moderate OAB/DO of ≥ six months duration will be evaluated. In~     each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo. .~      In addition secondary efficacy parameters will be evaluated (change from baseline compared~     to placebo), including number of micturitions per day, volume of micturitions, incontinence~     episodes, pad weight, uninhibited contractions during cystoscopy, and quality of life~     assessments.~   "
90701|NCT01870024|"~     The main purpose of this study is to know on one hand if lorazepam is more (effective) than~     clonazepam and on the other hand if lorazepam is also effective as the association~     clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status~     epilepticus in adult patients.~   "
90702|NCT01870011|"~     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and~     long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R~     injury and maintaining renal function during renal transplant surgery is therefore very~     important in order to improve post-operative outcome. This purpose of this study is to~     investigate whether propofol anesthesia done in both kidney donors and recipients during~     deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury~     via its antioxidant and antiinflammatory properties and improve post-transplant outcome~     compared to desflurane anesthesia.~   "
90703|NCT01869998|"~     Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting~     Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter~     Prospective Randomized Clinical Trial; INNOVATION study~   "
90704|NCT01869985|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.~   "
90705|NCT01869972|"~     Phenylketonuria (PKU) is a rare disease where the level of phenylalanine (one of the amino~     acids) in the body is greatly increased. High levels can cause brain damage, especially in~     babies and children. This brain damage can be prevented if a special low phenylalanine diet~     is started soon after birth. A new drug, sapropterin, can also lower phenylalanine levels in~     some patients. PKU therapy is monitored by measuring the blood phenylalanine every week,~     with the goal to keep the level within a target range. Recently, studies have suggested that~     the variation in the blood phenylalanine may be just as important as the absolute blood~     phenylalanine level for brain outcome.~      The investigators will look at the variation in blood phenylalanine level over 24 hours to~     see how much the level changes. The investigators will measure this in patients with typical~     PKU who are compliant with the diet and in patients who are not compliant with the diet. The~     investigators will also measure this in patients with mild PKU who do not usually have as~     high levels of phenylalanine. Finally, the investigators will see if patients on sapropterin~     have lower variation.~   "
90706|NCT01869959|"~     The main purpose of this study is to evaluate the safety and tolerability of a drug called~     LY2405319. It will be given as a daily injection under the skin to participants with type 2~     diabetes mellitus (T2DM) for 28 days. This study will determine how long the drug stays in~     the body and how it affects blood sugar levels. After screening, the study will last about 2~     months for each participant. Participants will continue their pre-study regimen of diet and~     exercise alone, or in combination with metformin.~   "
90707|NCT01869946|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip~     replacement surgery. The investigators plan to measure these levels by testing blood samples~     taken over a timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
90763|NCT01869218|"~     This study is aimed to determine the feasibility of obtaining and molecularly characterizing~     pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly~     characterizing archival and post-treatment tumor biopsies, to assess molecular expression~     changes between archival and baseline tumor samples, and to assess molecular expression~     changes between tumor samples obtained at baseline and at the time of disease progression.~   "
90764|NCT01869205|"~     To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients~   "
90708|NCT01869933|"~     The present study is intended to evaluate the safety and tolerability of topical OC-10X~     Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA)~     has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under~     development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related~     Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated~     both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of~     AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent~     without the traditional toxicity and works downstream independently of growth factors. As~     demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a~     new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by~     the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage~     into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years~     or more. If administration of OC-10X is well tolerated as a topical eye drop and is well~     tolerated systemically, then OC-10X will have the potential to provide benefits to patients~     with ocular diseases associated with angiogenesis.~   "
90709|NCT01869920|"~     Hypothesis: An educational intervention increases the proportion of mother-infant pairs~     using exclusive breastfeeding~   "
90710|NCT01869907|"~     The purpose of this study is to determine if minocycline is effective in the treatment of~     neuropathic pain. The effect of minocycline will be compared to the effect of placebo and~     amitriptyline.~   "
90711|NCT01869894|"~     Our study is the prospective randomized study for efficacy of uncovered double bare metallic~     stent compared to uncovered single bare metallic stent in malignant biliary obstruction~   "
90712|NCT01869881|"~     Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have~     Type 2 Diabetes by using sarpogrelate and placebo.~   "
90713|NCT01869868|"~     The purpose of this study is to determine functional and structural changes in brain~     following treatment of severe depression with electroconvulsive therapy with correlation to~     clinical outcome. Our hypothesis is that there are state-dependent changes in functional~     connectivity within specific neurocircuits systems, as well as structural plasticity changes~     in hippocampus, when recovering from depression.~   "
90714|NCT01869855|"~     The aim of our study is to investigate in randomized controlled fashion whether the~     recurrence and complication rate, after insertion of subperiosteal drainage in the treatment~     of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~      We hypothesize that patients treated with a subperiosteal drainage do not show higher~     recurrence rates than those treated with a subdural drainage, and suffer less complications.~   "
90715|NCT01869842|"~     Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and~     expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas~     by improving the parameters of the best stent will be useful. However, for better results~     for optical coherence tomography in percutaneous interventions have little useful data on~     the role. Randomized controlled study of the traditional percutaneous coronary intervention~     and intervention using optical coherence tomography.~   "
90716|NCT01869829|"~     The overarching objective is to ultimately develop new evidence-based treatment guidelines~     for invasive fungal infections in children. To accomplish that, this protocol will focus on~     two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or~     triazole antifungal therapy for pediatric invasive candidiasis; 2) Characterize the~     incidence of pediatric invasive candidiasis.~   "
90717|NCT01869816|"~     Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in~     industrialized countries. Adipose tissue secretes various kinds of bioactive molecules~     termed adipokines which contribute to the development of obesity-related disorders including~     cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel~     adipokines. Therefore, the investigators tried to compare circulating CTRP-3 and progranulin~     levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly~     associated with CAD prevalence after adjustment for well-known CAD risk factors.~   "
90718|NCT01869803|"~     This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or~     refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies,~     such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the~     ability of cancer to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them.~   "
90719|NCT01869790|"~     The purpose of this study is examine the effect of different fat types on postprandial~     glucose control in patients with type 1 diabetes.~      Subjects will have several admissions and, in random order, will receive lunches with~     identical carbohydrate content but different fat content: lunch A will minimal fat content,~     lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will~     contain added cheese. Total fat content in lunches B-D will be the same. Subjects will~     receive identical insulin doses (calculated using the subject's usual~     insulin-to-carbohydrate ratio) for the meals.~      The investigators hypothesize that, despite identical carbohydrate content,the lunches~     higher in saturated fat will lead to more postprandial hyperglycemia than the lunch~     containing minimal fat and the lunch high in monounsaturated fat.~      The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B,~     C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will~     be greater than that of Lunch A and C.~   "
90720|NCT01869777|"~     This clinical trial studies bioelectrical impedance measurement for predicting treatment~     outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as~     bioelectrical impedance measurement, may help predict a patient's response to treatment for~     acute leukemia.~   "
90721|NCT01869764|"~     This phase II clinical trial studies how well omega-3 fatty acid works in treating patients~     with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from~     breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the~     effects of omega-3 fatty acid on tumor cells.~   "
90813|NCT01868542|"~     This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of~     Levemir® (insulin detemir) administered once daily according to two titration algorithms~     after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin~     treatment with or without other anti-diabetic drugs (OADs).~   "
90722|NCT01869751|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Colonic~     transit time is an important determinant of intestinal generation and uptake of bacterial~     metabolites. However, it is unknown if accelerating the colonic transit time reduces the~     intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. Prucalopride is a~     selective, high-affinity 5-HT4 receptor agonist with a stimulating effect on colonic~     motility and transit. It is currently used in treating chronic slow-transit constipation. An~     observational study will be initiated in non-chronic kidney disease patients with chronic~     slow-transit constipation necessitating treatment with prucalopride to observe its effect on~     serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.~   "
90723|NCT01869738|"~     To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked~     arteries in coronary arteries in patients undergoing a stenting procedure due to having a~     heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS)~     or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent~     will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure~     ECG as compared to the comparator stent, and will have a similar effect on the rate of~     all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.~   "
90724|NCT01869725|"~     This clinical trial studies gallium Ga 68-edotreotide positron emission tomography~     (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus~     contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other~     somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga~     68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive~     neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective~     as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging~     of patients with neuroendocrine tumors.~   "
90725|NCT01869712|"~     To assess the application of partially randomized patient preference (PRPP) trial model~     which concerns the patients' preference on evaluation the therapeutic effect of~     non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of~     non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.~   "
90726|NCT01869699|"~     The purpose of this study is to compare the effects of intravenous acetaminophen to placebo~     on body temperature and hemodynamic (heart rate and blood pressure) responses in febrile~     critically ill adult patients.~      There are limited data to explain the variable and unpredictable antipyretic and hemodynamic~     response to acetaminophen in febrile ICU patients. The complex pathophysiology of critically~     ill patients, co-morbid conditions, the effect of multiple pharmacologic and~     non-pharmacologic care interventions, and/or the potential interferences with absorption of~     enteral or rectal formulations may be related to variations in the antipyretic response to~     acetaminophen. It is necessary for clinicians to have a better understanding of the therapy~     response and potential adverse effects of this commonly administered medication, especially~     the recently available IV formulation, in critically ill patients. Further research of the~     antipyretic response to acetaminophen in critically ill patients is warranted to inform~     evidence-based practice guidelines for fever management. Further randomized,~     placebo-controlled studies of hemodynamic responses to IV acetaminophen are also warranted.~      Primary Hypothesis:~      There is a significant reduction in time-weighted average core body temperature over 4 hours~     after administration of IV acetaminophen compared to placebo in febrile critically ill~     patients.~      Secondary Hypotheses:~        1. There is a significant reduction in time-weighted average heart rate over 4 hours after~          administration of IV acetaminophen compared to placebo in febrile critically ill~          patients.~        2. There is a significant reduction in time-weighted mean arterial pressure over 4 hours~          after administration of IV acetaminophen compared to placebo in febrile critically ill~          patients.~      Adult patients with fever (≥ 38.3ºCentigrade/101ºFarenheit) in the intensive care unit will~     be screened for eligibility and enrolled after informed consent. Patients will be randomized~     to receive IV acetaminophen 1 gram or normal saline 100 mLs. Body temperature, heart rate,~     and blood pressure will be measured at baseline and during the 4 hours post study drug~     administration.~   "
90727|NCT01869686|"~     This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12~     healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects~     will be followed by a 105 day treatment-free follow-up period.~   "
90728|NCT01869673|"~     Difficult mask ventilation is usually studied in relation to airway management and difficult~     intubation and mostly during the induction period of anesthesia.~      According to the closed claim reports tracheal extubation and recovery of anesthesia is~     associated with brain damage or death.~      Difficult mask ventilation can also be a problem during the emergence phase of anesthesia~     after extubation. Especially after nasal surgery the use of nasal tampon and casts can~     resemble upper airway obstruction and facial deformity and cause difficult mask ventilation.~      The effectiveness of ventilation is affected by the design of the mask. Leaks may develop~     due to the inability to obtain a tight seal.~      The use of an oral mask for ventilation in patients with nasal tumors and after rhinoplasty~     for patients with a nasal cast has been reported. This suggests that oral mask ventilation,~     rather than face mask ventilation, should be considered after nasal surgery.~      The aim of this prospective randomized study is to compare the face mask and oral mask~     ventilation after nasal surgery in terms of the mask ventilation classification, airway~     pressure, minute ventilation and tidal volume.~      Our hypothesis is that ventilation with oral mask would provide better airway pressures,~     superior mask-ventilation classification and higher tidal volumes compared to face mask~     ventilation in patients with obstructed nasal pasage (nasal packing and/or cast) after nasal~     surgery'.~   "
90729|NCT01869660|"~     To determine whether shared decision making (SDM) intervention improves patient satisfaction~     in patients with first-admission schizophrenia compared with usual care.~   "
90730|NCT01869647|"~     This is the third phase (feasibility and impact) of a three-phase project designed to~     derive, validate and test the feasibility and impact of implementing clinical decision~     support to safely limit the use of Computerized Tomography (CT) and its accompanying~     radiation and cost in emergency department patients with suspected renal colic.~      Hypothesis: Using a before and after model, integration of a clinical prediction rule into~     decisions about imaging in patients with suspected renal colic will result in a reduction of~     between 25-50% of radiation received from CT scanning in this population, without adverse~     affects on patient-centered outcomes.~   "
90731|NCT01869634|"~     Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to~     repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of~     differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and~     improved HIV-associated cardiovascular disease (CVD) risk.~   "
90732|NCT01869621|"~     The trough concentration of metformin will be examined in monozygotic and dizygotic twins.~     Current twin study will determine the total weight of genetics on the trough concentration~     of metformin.~   "
90733|NCT01869608|"~     Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as~     hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner~     of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum~     screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance~     test (OGTT).~      However, less than a quarter of these women are screened. This recommendation has failed for~     multiple reasons; the most important being that busy new mothers must deal with the major~     inconveniences of returning to a sampling center for a 2h testing session, bringing baby~     along or paying for a sitter, transportation, parking… A mother-friendly solution is direly~     needed.~      The investigators hypothesize that, in these women, results of an OGTT performed after~     delivery on the last day of their hospital stay (OGTT-1) will predict results of the~     recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.~      The main aim of our project is to determine the optimal cut-off value for the 2h glucose~     result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the~     gold standard), in the same woman.~   "
90734|NCT01869595|"~     Objectives~        1. To determine the uptake of universal HIV testing among Thai men who have sex with men~          (MSM) and transgender women (TG)~        2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among~          Thai MSM/TG who test positive for HIV~      Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18~     years old, Have engaged in anal intercourse with a man without using a condom at least one~     time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not~     known to be HIV-positive (either have never been tested for HIV or have had a previous~     negative HIV test)~      Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in~     Lampang and 5-12% in Ubonratchathani.~   "
90735|NCT01869582|"~     Safer Births is a research and development collaboration to establish new knowledge and new~     innovative products to better equip and increase competence of health workers for safer~     births and increased newborn survival worldwide.~      The main objectives are:~      To randomize different devices for fetal heart rate assessments. To assess if a novel~     Newborn Resuscitation Monitor will facilitate newborn resuscitation in a low-resource~     setting. To determine bag mask ventilation treatment and devices beneficial for neonatal~     outcome.~   "
90736|NCT01869569|"~     Rationale: Pregabalin is effective on radiation-induced peripheral neuropathic pain.~      Purpose: This randomized double-blind trial aims to investigate whether pregabalin is~     effective in treating radiation-induced peripheral neuropathic pain.~   "
90737|NCT01869556|"~     Patients having Cesarean section after they have been in labor for many hours bleed much~     more, in average twice as much, as compared with patients having an elective Cesarean~     section. The investigators believe a simple change in practice might contribute to reduce~     this bleeding. This study will involve the use of oxytocin (also known as syntocinon),~     ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is~     routinely used to help contract the uterus and keep it contracted after the delivery of the~     baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given~     through the intravenous line, while carboprost is given as an injection in the muscle.~     Although they are not routinely given in every case, these are very frequently given as~     rescue medications to patients who fail to respond appropriately to oxytocin. This study is~     designed to determine if ergonovine or carboprost given in association with oxytocin, in a~     preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss~     during Cesarean sections following a trial of labour.~   "
90738|NCT01869543|"~     Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study~     to look at the effectiveness of high efficiency filtration of indoor air in homes on~     reducing asthma symptoms. One intervention group will have high efficiency filters or~     filtration systems installed in their central heating and air conditioning (HVAC) system.~     The second intervention group will have high efficiency portable air cleaners placed in the~     child's bedroom and in the main living area. Each participant will receive true air~     filtration for a year and a placebo for a year. During the placebo period a sham filter will~     be used that removes very little of the particles. Measures of health effects will include~     days of symptoms, unplanned utilization of the healthcare system for asthma-related illness,~     short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).~   "
90739|NCT01869530|"~     TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy~     children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life~     exposures to health problems including obesity, micronutrient deficiencies, and~     developmental problems.~      TARGet Kids! represents an innovative collaboration between child health researchers and~     children's primary care doctors (pediatricians and family physicians) to promote research~     that really matters and create solutions to some of the today's biggest health concerns. The~     results of this collaborative research study are not only improving the quality of~     children's healthcare but also the health of children across the country. Coordinated by~     Sick Kids and St. Michael's Hospital with data management services by the Applied Health~     Research Centre (AHRC), TARGet Kids! is the only primary care research network for children~     in Canada.~   "
90740|NCT01869517|"~     Various approaches, including surgical and non-surgical management have been proposed for~     keratoconus. One of the surgical procedures is Intrastromal Corneal Ring implantations that~     have been designed to achieve refractive readjustment by flattening the cornea. There are~     different models of Intrastromal Corneal rings available: intrastromal corneal ring segments~     (ICRS) such as Keraring and intrastromal corneal continuous ring (ICCR) like Myoring.~      Most studies of these two types of ring implantation outcomes are retrospective case series.~     Thus, this Randomized Clinical Trial study was designed with the aim of Comparing visual and~     refractive outcomes and complications of insertion Myoring versus Keraring using Femtosecond~     laser. Keratoconus patients with compound myopic astigmatism who meet the inclusion criteria~     will randomly allocated to the Keraring and Myoring groups. Subsequently, the clinical~     outcomes of two groups will be compared at one,3 and 6 months after surgery.~   "
90814|NCT01868529|"~     This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic~     (the effect of the investigated drug on the body) response of insulin degludec (insulin 454)~     with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.~   "
90744|NCT01869465|"~     Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo~     and Nebbi reported unwillingness to take preventive treatment. A particular study conducted~     in primary schools of Jinja district showed that only 30% of school children took~     praziquantel during the 2011 Mass Drug Administration (MDA). Fear of side effects of~     praziquantel, lack of knowledge about schistosomiasis transmission and prevention and lack~     of teacher support were some of the major factors associated with the low uptake. Similar~     reasons for non-uptake have been reported elsewhere. Thus, measures are needed to increase~     uptake of Mass Drug Administration (MDA) in Uganda. There is no doubt that health education~     facilitates a better understanding of the obvious risks to health, including the knowledge~     of preventing parasitic infections among primary school children. Better compliance to~     treatment for schistosomiasis among school children can be achieved through implementing~     carefully designed programs involving face to face education methods. Increasing knowledge~     about schistosomiasis transmission and prevention and implementing measures to mitigate the~     side effects attributable to praziquantel, such as providing a snack prior to drug~     administration may improve uptake of the drug among school children.~      Hypothesis- Provision of a pre-treatment snack is effective in improving uptake of~     preventive treatment for intestinal schistosomiasis among primary school children.~   "
90745|NCT01869452|"~     A first therapeutic education is given before patient's discharge at the hospital, then a~     dedicated nurse follows patients through the phone,regularly according to patients' needs,~     continues to give advise on risk factors, information on medication and alert symptoms and~     therapeutic education.~   "
90746|NCT01869439|"~     The purpose of this study is to test wounds found on the outside of the body surface with an~     investigational medical imaging device that collects visual pictures and thermal digital~     pictures of the wound site. The investigational device has not been approved by the Food and~     Drug Administration (FDA).~      The medical imaging device is non-contacting and is non-radiating (delivers no energy to the~     body). It passively collects pictures (typical digital color photographs)and thermal~     pictures (black and white digital photographs of heat at the body surface.)~   "
90747|NCT01869426|"~     Infantile colic is one of the most commonly reported medical problems within the first three~     months of life causing appreciable distress for both parents and pediatricians.~      It appears that multiple independent origins might be involved: amongst them infant's~     difficult temperament, inadequate mother-infant communication or maternal anxiety, transient~     lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal~     smoking during pregnancy or after delivery. Consequently, various treatment approaches have~     been tried to alleviate this condition.~      Recent studies have suggested that changes of intestinal microflora of a newborn may play an~     important role in pathogenesis of infantile colic. Therefore, dietary supplementation with~     probiotics has been proposed for the improvement of this condition.~   "
90748|NCT01869413|"~     A cystectomy is the removal of the bladder and adjacent organs in patients with bladder~     cancer. This often results in significant blood loss, and about 60% of patients will require~     a blood transfusion during or up to 30 days after surgery. Significant blood loss may result~     in cardiovascular morbidity, and the use of blood products are expensive and expose patients~     to risk.~      Tranexamic acid reduces breakdown of hemostatic blood clots and it has therapeutic benefit~     when used in other surgical procedures to reduce blood loss and the need for transfusion.~     The current study will be the first to evaluate whether tranexamic acid is effective and~     safe to use during radical cystectomy. The results of the study will have an immediate~     impact on patient care.~   "
90749|NCT01869400|"~     Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined~     patient groups, which are not representative for the whole patient population.~      Especially elderly patients and patients with co-morbidities are underrepresented in~     clinical trials.~      This non-interventional study will examine the efficiency and toxicity of the Yondelis® +~     PLD combination therapy in a general patient population to evaluate if the data collected in~     the clinical trials can be assigned to a general patient population.~   "
90750|NCT01869387|"~     There is evidence that noninvasive mechanical ventilation (NIV) is effective in the~     treatment of severe exacerbations of COPD presenting respiratory acidosis.~      The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in~     patients with COPD exacerbation and hypercapnic respiratory failure without acidosis~     requiring hospital admission. It is known that NIV improves respiratory mechanics, so the~     primary outcome will be respiratory muscle function.~      All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory~     failure without acidosis will be included for a period of 12 months. The patients will be~     randomized into two groups (conventional treatment or conventional treatment plus NIV).~     Clinical data, blood gases, muscle strength parameters will be collected at the inclusion~     time and 24h after starting NIV. Quality of life and hospital stay will be measured at~     discharge. All patients will be followed for a year.~   "
90751|NCT01869374|"~     To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in~     elderly patients with a major depressive episode, who are randomly assigned to receive an~     acute course of MST or ECT.~      The investigators hypothesize:~        1. MST and ECT will have similar antidepressant efficacy~        2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures~          of anterograde and retrograde amnesia following the acute treatment phase.~        3. At follow up, MST will show a lesser degree of persisting deficit in measures of~          retrograde amnesia than ECT.~   "
90752|NCT01869361|"~     Background: Indomethacin is frequently used as a tocolytic, however there is currently only~     scant evidence to support its efficacy.~      Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and~     maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin~     for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor~     randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48~     hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously~     administered, and magnesium sulfate for neuroprotection. Ultrasound performed before~     initiation of study drug and after completion of study medication for amniotic fluid index~     and fetal cardiac assessment.~   "
91693|NCT01856998|"~     The purpose of this study is to evaluate the therapeutic equivalence, based on~     pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL~     (AstraZeneca), administered by target controlled infusion (TCI).~   "
90753|NCT01869348|"~     As individuals age, their physical activity decreases and sedentary time increases. Even~     small changes in these two behaviors can greatly decrease risks for several major health~     problems, including cardiovascular disease, diabetes, and many cancers. Studies that use~     pedometers to encourage walking have successfully increased physical activity, but do not~     address sedentary behaviors such as television watching. The investigators propose to use a~     novel pedometer-like device (Jawbone Up) that encourages both increased physical activity~     and decreased sedentary time. First, the investigators will recruit 10 adults to participate~     in a brief intervention for six weeks. They will wear the wrist-based activity monitor and~     use a mini-tablet device to see feedback on their activity and sedentary time. They will~     also receive brief counseling weekly. The investigators will use this first study to~     investigate the basic feasibility of the intervention materials. Next, the investigators~     will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a~     waiting list. Here, the investigators will test the intervention with refinements made based~     on participant responses from the first small study. Our primary outcomes will be measures~     of feasibility and acceptability across all parts of the study. The investigators~     hypothesize that the intervention will be feasible and acceptable to the participants. The~     investigators will also measure physical activity, sedentary behavior, fitness, body fat,~     and psychological feelings of motivation.~   "
90754|NCT01869335|"~     Radiography of breast specimens is currently the only radiological procedure used to verify~     removal of microcalcifications and presence of tumor-free margins after breast surgical~     resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not~     detected by radiography in resected breast tumor specimens and/or its ability to verify~     tumor-free margins in breast cancer detected by MRI only.~   "
90755|NCT01869322|"~     When people break their arm and arrive at Oregon Health and Science University's Emergency~     Department (OHSU ED), they are treated with a short-term means of immobilizing their broken~     arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a~     plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the~     arm steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma~     clinic where they will receive definitive evaluation and stabilization/fixation. In much of~     the orthopaedic literature coaptation splints are the default immobilization method. The~     investigators hypothesize however, that sling and swathe immobilization may be equally~     effective for short term stabilization, while being faster to apply, and more comfortable~     for the patient. This randomized, unblinded prospective study will follow the satisfaction,~     quality of life and limited functional outcomes of all enrolled participants during the~     first week following their injury.~   "
90756|NCT01869309|"~     The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg~     LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who~     exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated~     Phosphoprotein-Phosphorylation (VASP-P) >50%.~   "
90757|NCT01869296|"~     The purpose of this study is to compare the cecal intubation rate between two endoscopy~     water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion~     colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.~   "
90758|NCT01869283|"~     Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with~     chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle.~     Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence~     of myofascial trigger points. These are related to the sensory, motor and autonomic changes,~     being defined as palpable nodules located in the taut band of skeletal muscle. In this~     context, the focus on treatment modalities stands out in the literature, however, other~     resources commonly used in clinical practice still lack scientific evidence. Therefore, the~     aim of this project is to evaluate the effectiveness of physiotherapy resources in the~     treatment of myofascial trigger points in the trapezius muscle of patients with neck pain.~     For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18~     and 59 years and bilateral myofascial trigger points in the upper trapezius will be~     randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2~     (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents,~     n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of~     treatment, being realized the following evaluations: surface electromyography, infrared~     thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin~     impedance. For data analysis, normality test will used to verify the data distribution and~     consistent statistical test for the appropriate comparisons within and between groups, and~     thus considered two factors in the comparisons, time and group. Will adopt a significance~     level of 5%.~   "
90759|NCT01869270|"~     Hypothesis: To study the natural history of Tay-Sachs disease and evaluate therapeutic~     interventions.~      This study is intended to work in collaboration with NCT00668187 A Natural History Study of~     Hexosaminidase Deficiency. Because so few patients with Tay-Sachs disease present annually,~     we will maximize both research projects by enrolling patients in both studies. For this~     present study, we will perform retrospective medical record review to gather data. Through~     this medical record review, we will collect biomarker analysis results, neuroimaging report~     data, quality-of-life questionnaire data and ophthalmology exam findings. If the subject has~     undergone therapy or treatment, the results will be noted.~   "
90760|NCT01869257|"~     Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors,~     surgical site infections (SSI) remain the most frequent complication of colorectal resection~     (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use~     of local antimicrobial agents seems successful.~      The primary aim of the present trial was to evaluate the efficacy of a surgical suture,~     coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate~     after colorectal operations.~   "
90761|NCT01869244|"~     The aim of the study is to collect comments form users of new type of hand resting splint.~   "
90762|NCT01869231|"~     Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil,~     in resolving postoperative ileus.~   "
90815|NCT01868516|"~     Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate~     with or without incontinence (leaking). The purpose of this study is to test whether~     dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of~     OAB.~   "
90765|NCT01869192|"~     A primary objective of this study is to evaluate the in vivo response of tumor to~     chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique~     opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor~     tissue. The investigators plan to evaluate several different questions by comparing gene~     profiles in different phases of treatment in this study. These are outlined below.~      Hypotheses~        1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and~          survival mechanisms. These mechanisms will in part be identifiable through changes in~          gene expression profiles pre vs. post treatment.~        2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging~          regimen (epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted~          regimen (docetaxel and capecitabine), will allow for the identification of a smaller~          set of genes associated to resistance and survival mechanisms of broad importance.~        3. Genes associated with enrichment for resistance and survival mechanisms will not be~          present in large amounts pretreatment in tumors destined for complete pathologic~          response.~   "
90766|NCT01869179|"~     The investigators will recruit 450 older adults and will utilize 12 Administration on Aging~     (AoA)-supported senior centers to implement a multisite, cluster randomized (by center),~     wait-list clinical trial. Centers will be randomized to receive the choir program~     immediately (intervention group) or after a 6-month delayed intervention phase (control~     group). The community choirs will be led by professional music directors. The investigators~     will assess both primary and secondary outcomes at baseline, 6 and 12 months, with the main~     intervention group comparison being at 6 months. The investigators will also evaluate the~     start-up and ongoing program costs for senior centers, including cost/person served and~     determine quality adjusted life years.~      The hypotheses are:~        1. Compared to delayed intervention controls, participation in a community choir program~          will be associated with improvements/maintenance on the primary outcomes of physical~          function (balance, walking speed, strength), depressive symptoms, and cognition~          (executive function and memory) at 6 months. The investigators also predict~          within-group improvements on these primary outcomes at 12 months.~        2. Compared to delayed intervention controls, participation in a community choir program~          will be associated with improvements in the secondary outcomes of well-being~          (depressive symptoms, loneliness, resilience, social participation, health-related~          quality of life, shortness of breath, functional status, falls, and health services~          use) at 6 months. The investigators also predict within-group improvements on these~          secondary outcomes at 12 months.~   "
90767|NCT01869166|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous T cells may make the body build immune response to kill cancer~     cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with EGFR positive advanced/unresectable operation solid tumors, such as~     lung cancer, colorectal cancer，ovary cancer，cholangiocarcinoma，pancreatic cancer，renal~     carcinoma and other relapsed/metastatic tumors.~   "
90768|NCT01869153|"~     Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow.~     The investigators will examine the use of a computer program to try and identify periods of~     growth slowing in preterm babies, and compare those results to the usual assessments made on~     patient care rounds.~   "
90769|NCT01869140|"~     To study the immediate effect of spinal manual therapy on pain perception in normal subjects~   "
90770|NCT01869127|"~     Small association studies have hypothesised that shoes protect against hookworm infection.~     The purpose of this pragmatic study was determine, under field conditions, whether~     school-age children on Pemba Island, Zanzibar, would wear shoes and if shoes protected them~     against hookworm infection.~   "
90771|NCT01869114|"~     This phase II trial studies how well sirolimus and azacitidine works in treating patients~     with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Sirolimus~     and azacitidine may kill more cancer cells.~   "
90772|NCT01869101|"~     The purpose of this observational study is to assess the treatment and outcomes of patients~     with prediabetes in community-based clinical practices.~   "
90773|NCT01869088|"~     The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5~     Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not~     amenable to surgery or local ablative therapy.~   "
90774|NCT01869075|"~     Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary~     embolism (PE, is one of the common and preventable complications of hospital stay. VTE~     prophylaxis through the use of evidence-based anticoagulant medication options or mechanical~     prophylaxis have been shown to reduce this risk and improve patient safety. Despite an~     abundance of evidence, use of VTE prophylaxis remains low.~      This study assesses the effectiveness of quality improvement strategies (use of pre-printed~     orders, audit and feedback, involvement of the pharmacist as project need and as a reminder~     to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study~     aims to measure if the use of these strategies improves the use of VTE prophylaxis and~     therefore, improves patient safety and patient care by reducing the risk of developing DVT~     or PE.~   "
90775|NCT01869062|"~     The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT~     parameters by SonR technology is able to increase the rate of CRT-D responders, based on~     significant LV reverse remodeling, as compared to Standard of Care settings.~      This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard~     of care (SoC) programming methods in providing appropriate LV filling, as expected from the~     Ritter method.~   "
90776|NCT01869049|"~     This project was undertaken by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to report the alteration on the macrophage function in the~     spleen tissue of primary immune thrombocytopenia (ITP).~   "
90777|NCT01869036|"~     The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal~     anesthesia in children who undergo renal surgery in our department.~   "
90778|NCT01869023|"~     Malignant pleural mesothelioma (MPM) is a rare disease, but with a very high mortality. MPM~     is frequently found in advanced stages. The standard treatment in advanced pleural~     mesothelioma is cisplatin-based chemotherapy combined with pemetrexed/raltitrexed (phase III~     studies showed its benefit in response and overall survival compared with cisplatin alone).~     There are other active drugs such as liposomal doxorubicin and gemcitabine. Unfortunately,~     cost is an important factor to consider in our population and standard treatments are very~     expensive. Gemcitabine 250 mg infused over 6 hrs in combination with cisplatin, compared to~     the standard administration of gemcitabine 1250 mg infusion of 30 minutes in NSCLC, combined~     with cisplatin showed 75 mg shown in a study to be equally effective in treating cancer~     non-small cell lung. A phase II study using this strategy for advanced MPM has shown~     promising results. Gemcitabine administered in low dose in a six hour infusion may reduce~     cost of treatment without altering the effectiveness.~      Primary Objective.~      -Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour~     infusion combined with cisplatin in patients with unresectable malignant mesothelioma.~      Secondary objectives.~        -  Evaluate toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over~          6 hours in with cisplatin in patients with unresectable malignant mesothelioma.~        -  Evaluate the progression free survival (PFS) and overall survival (OS) in patients with~          unresectable MM treated with this combination.~      Hypothesis:~      Combination therapy of gemcitabine at a dose of 250 mg/m2 infusion of 6 hrs applied on day 1~     and 8 combined with cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles is a treatment~     that provides similar results in responses when compared with previous studies with the same~     combination therapy, but with a conventional administration (gemcitabine 1,250 mg in 30~     minutes on days 1, 8 and 15).~   "
90779|NCT01869010|"~     The objective of the present study is to analyze the overall tubular function, and in~     particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in~     patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment~     in comparison with seronegative controls, by applying a validated tubular physiological test~     known as Low sodium infusion test.~      Hypothesis is that patients with HIV infection and normal renal function will show~     subclinical tubular abnormalities compared with seronegative controls~   "
90780|NCT01868997|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of a~     fully human antibody compared to placebo in the treatment of patients with active thyroid~     eye disease.~      Funding Source - FDA OOPD~   "
90781|NCT01868984|"~     The objective of this study is to evaluate the safety and effectiveness of the use of~     intravascular paclitaxel, in addition to standard therapy, for the treatment of~     arteriovenous dialysis access fistula stenosis.~      A fistulogram will be performed in standard fashion. The diagnostic component will include~     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or~     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and~     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur~     at this point.~      All patients will then receive standard therapy for their stenosis. This will include~     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond~     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)~     will be stented. Stent selection will be based on clinical setting. Initial stent treatment~     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include~     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).~     Documentation of location and type of treatment for each lesion treated will be recorded.~      Once standard treatment is completed, the operating surgeon will be informed of the patient~     randomization: treatment (paclitaxel) or control. For subjects assigned to treatment,~     Paclitaxel solution treatment of each lesion encountered from proximal to distal will be~     attempted until the 20 mg Paclitaxel dose limit is met.~      A TAPAS infusion catheter will be used for all paclitaxel dose administrations. The TAPAS~     infusion catheter will be positioned to reduce the presence of branches which permit the~     loss of paclitaxel from the treatment zone. After the full outflow vein segment is treated,~     the fistulogram is completed in the standard fashion. Prior to removal of the sheath, a~     final angiographic study of all areas treated is performed to document patency and lesion~     appearance.~      For the control group, instead of paclitaxel administration, a sham treatment period of 10~     minutes is allowed to elapse followed by the performance of the final completion angiogram.~     Any additional lesions identified with this study are then treated appropriately following~     standard technique.~      All patients will follow the same follow up evaluation schedule.~   "
90782|NCT01868958|"~     More than half of the middle-aged population has radiologic evidence of cervical spondylosis~     (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy~     (CSM), a condition in which the spinal cord is impaired, either by direct mechanical~     compression or indirectly by arterial deprivation and/or venous stasis. In this study we aim~     to test the hypothesis that diffusion tensor imaging can provide prognostic information on~     the integrity of the spine in these patients which is unavailable from conventional MRI~     images~   "
90783|NCT01868945|"~     The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of~     vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in~     physically frail elderly people after 24 weeks of daily supplementation with different doses~     of Hy.D Calcifediol 25 SD/S compared to vitamin D3.~   "
90784|NCT01868932|"~     Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used~     in bronchodilator therapy for acute viral wheezing in all children under age 6 years will~     provide superior symptom relief leading to decreased admission rates from the Emergency~     Department.~      The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered~     with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group)~     in a prospective, double blind, randomized controlled, multi-centre clinical trial of~     children under age 6 years presenting to the ED with acute viral-associated wheezing.~   "
90785|NCT01868919|"~     Joint research (quantitative and qualitative methodology) with quasi-experimental design,~     before-after without control group to evaluate the pilot implementation of Positive~     Parenting Program (Triple P) in the context of primary health care in Chile. The hypothesis~     is that the program is feasible and acceptable to the Chilean population.~   "
90786|NCT01868906|"~     The aim of this study is to assess, with 18F-FMISO PET, hypoxia in high grade gliomas and~     changes by spinal cord stimulation in a subset of patients. Additionally, the potential~     correlation with pathological, imaging and clinical parameters will be analyzed.~   "
90787|NCT01868893|"~     This is a multicenter, open-label, single-arm, expanded access treatment study designed to~     provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia~     (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of~     obinutuzumab administered in combination with chlorambucil. This study will enroll patients~     with previously untreated CD20-positive CLL requiring treatment according to the IWCLL~     guidelines (Hallek et al 2008), as assessed by the investigator.~   "
90788|NCT01868880|"~     The aim of this prospective, randomized and controlled trial is to evaluate the use of the~     ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of~     beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in~     single-chamber or dual chambers ICD recipients HF patients with moderate to severe left~     ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a~     12-months follow up.~      Besides the investigators want to assess if the combination of ivabradine to a low-dose of~     beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a~     lower degree of left ventricular dysfunction progression, the reduction of ventricular~     arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of~     life in ICD heart failure patients.~   "
90789|NCT01868867|"~     The goal of this study is to examine the use of new technologies in disseminating and~     improving CBT treatment for adolescent depression. An on-line therapist training tutorial~     will be followed by 12 weeks of CBT treatment according to the training protocol. CBT~     treatment will be augmented with the use of automated text messages for homework reminders~     and reinforcement of learning. In session patient education and review of CBT concepts will~     be augmented through teaching materials delivered via iPad. 16 therapists will be recruited,~     each treating 4 depressed adolescents. Half the therapists will be randomly assigned to TAU,~     followed by the training intervention. Automated patient outcomes measures will be examined.~   "
90790|NCT01868854|"~     The location of the catheter tip in radiographic planes 1 and 2, is a protection factor for~     the mechanical performance of peritoneal Dialysis. Instead radiographic planes 3 and 4 are~     risk factors.~   "
90791|NCT01868841|"~     The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when~     derived from a large field of view Anger SPECT system and from a small field of view high~     sensitivity (CZT) SPECT system.~   "
90792|NCT01868828|"~     A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately~     50 previously untreated subjects with multiple myeloma will be enrolled. The study will~     consist of 6 phases, screening, treatment and follow-up.~   "
90793|NCT01868802|"~     A randomized multicentric parallel arms study involving the use of ketamine for~     treatment-resistant depression will be held at three national health provider clinics in the~     Mexican population. The purpose of this study is to determine whether clinical response seen~     in previous studies is replicable in this population.~   "
90794|NCT01868789|"~     The purpose of this study is to compare the average joint motion and joint axis orientation~     of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder~     (AAFD) and a control group of patients without foot deformity, using weight-bearing CT~     technology.~   "
90795|NCT01868776|"~     The purpose of this study is to determine the effect of buffered lidocaine (a numbing~     solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing)~     solutions have shown promise in some medical and dental research. Patients presenting with~     toothaches will be given either a buffered numbing solution or a nonbuffered numbing~     solution. Neither the patient nor the operator will know which solution they will receive.~     Root canal treatment will be performed on the tooth and the ability of the buffered versus~     non-buffered numbing solutions will be compared.~   "
90796|NCT01868763|"~     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching~     have the potential to support lifestyle change and weight loss. Therefore, the aim of our~     randomized controlled trial was to examine the effect of telemedicine with and without~     coaching in comparison to a control group on weight loss in overweight participants.~   "
90797|NCT01868750|"~     One of the major side effects of surgery to remove the thyroid gland is transient (lasting~     for a short time) low calcium levels in the blood, or hypocalcemia. Low calcium levels can~     cause symptoms such as numbness around the mouth, tingling or cramping in the hands and~     feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat)~     abnormalities. Severe symptoms are life threatening, so it is important to start the~     management of these symptoms in the hospital. Treating low calcium levels sometimes require~     patients to spend a few extra days in the hospital.~      The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get~     the calcium needed to make strong bones and teeth. The purpose of this study is to determine~     if taking vitamin D before surgery to remove the thyroid gland affects whether or not you~     may have low calcium levels after your surgery and to test the hypothesis that those who are~     given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital~     stay.~   "
90798|NCT01868737|"~     A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal~     high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the~     period July 2011 to August 2012. The primary objective of the study was to assess the effect~     of probiotics on the incidence of NEC in high risk infants born to HIV-positive and~     HIV-negative women.~      Throughout the study period, the standard of care protocol consisted of one dose (5 drops)~     probiotic/placebo daily for 4 weeks (28 days). This provided the study group with L.~     rhamnosus GG (0.35 x 109 colony-forming units [CFU]) and B. infantis (0.35 x 109 CFU) daily.~     The control group received placebo consisting of medium chain triglyceride (MCT) oil.~     Supplementation of the probiotic/placebo was initiated when enteral feeds started.~     Probiotic/ placebo supplementation was delayed/ halted in the event of: the infants being~     nill per os (NPO); when a query Necrotizing Enterocolitis (NEC) was suspected the infant~     continued with treatment until a confirmed a positive diagnosis of NEC I was made through~     abdominal X-ray; if the infant remained a query NEC and was NPO the infant did not receive~     probiotics/ placebo until the enteral feeds were commenced again. Supplementation was~     discontinued when HIV-exposed infants had a positive polymerase chain reaction (PCR) result~     on day 14 of life.~      All study participants received human breast milk. Both the probiotics and placebo were~     mixed with the mothers own breast milk or donor breast milk before administration via the~     orogastric tube or orally. The probiotic/ placebo was added to the breast milk by the~     researcher and two research assistants who were blinded and not involved in the routine care~     of the infants. Participants exited the study on day 28 after birth or upon discharge from~     the hospital.~   "
90799|NCT01868724|"~     This study is to collect blood and urine samples to help identify and validate protein~     biomarkers of recovery from moderate or severe acute kidney injury (AKI).~   "
90800|NCT01868711|"~     Psychological mindedness(PM) is a meta cognitive process in which the person uses his~     cognitive and affective abilities to better understand his thoughts, feelings, and his~     behaviors as they interact with his internal experiences and his external experiences in the~     world, and dynamically modifies his behavior to move towards self actualization, in a manner~     positive to himself and the world. We investigate whether assessment of PM can distinguish~     depressed patients who benefit from CBT.~   "
90816|NCT01868503|"~     This phase II trial studies how well lapatinib ditosylate and radiation therapy work in~     treating patients with locally advanced or locally recurrent breast cancer. Lapatinib~     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib~     ditosylate together with radiation therapy may be an effective treatment for breast cancer.~   "
90801|NCT01868698|"~     Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a~     narrowing or occlusion of the artery diameter due to aneurysms, inflammation,~     atherosclerosis and thromboembolic events. One of the main risk factors for the development~     of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the~     objective of this study is to evaluate the effects of three treatment modalities for PAD on~     the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three~     types of treatment, the order defined according draw: high voltage electrical stimulation,~     shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by~     Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase~     the circulation of the lower limb.~   "
90802|NCT01868685|"~     The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in~     Group III failure to wean patients, as compared to placebo controls.~   "
90803|NCT01868672|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S. over the past two decades has left smoker's~     homes as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has~     considerable potential to reduce smoke exposure, but suitable channels to reach low-income~     families are limited.~      The proposed research will systematically test an intervention designed to create smoke-free~     homes in low income households among 2-1-1 callers. During this randomized control trial,~     researchers will disseminate and evaluate a brief smoke-free homes intervention through the~     established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally~     designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for~     directory assistance, that links callers to community-based health and social services. The~     main hypothesis to be tested is that a higher proportion of households in the intervention~     group will establish and maintain a smoke-free home than in the measures-only control group.~   "
90804|NCT01868659|"~     Diagnostic errors are common, but they have been largely ignored by patient safety groups.~     Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics~     (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors,~     but we know little about how to resist them. Faulty thinking has plagued other high-risk,~     high-reliability professionals, such as airline pilots and nuclear plant operators. These~     professions have learned from their mistakes and have developed checklists to help prevent~     them. The medical profession has started to use checklists and time-out periods in the~     operating room and intensive care unit, but these strategies have not been used to reduce~     diagnostic errors. The most common reason that physicians fail to make the correct diagnosis~     is that they never consider it. This failure could potentially be prevented if the physician~     took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic~     errors by developing interventions that help counter faulty diagnostic thinking. The~     specific aims of this project are to (1) determine the feasibility of taking a diagnostic~     time-out in the acute outpatient setting (urgent care clinic and emergency department), (2)~     determine if new diagnostic possibilities are seriously considered as a result of the~     time-out and checklist, and (3) compare the initial differential diagnosis with the new~     differential diagnosis following the time-out, and with the discharge diagnosis documented~     in the medical record, and with the final diagnosis based on a one-month follow-up. To~     achieve these aims, the investigators will ask 5 urgent-care physicians to complete a~     time-out procedure for 10 diagnostically challenging adult patients and 5 physicians will~     serve as controls (no time out) for 10 diagnostically challenging patients (total of 100~     patients). The investigator will ask the intervention physicians to take a 2-minute time-out~     to review a complaint-specific differential-diagnosis checklist, which includes the~     differential diagnosis for 60 common presenting complaints, such as dyspnea and chest pain.~     The time-out will occur at the conclusion of the history and physical exam. We will use~     descriptive statistics and qualitative methods to characterize physicians' reactions to the~     time-out and checklists. We will use this pilot project to plan a larger study that will~     determine the risks and benefits of diagnostic time-outs and checklists.~   "
90805|NCT01868646|"~     The purpose of this study is:~        -  to assess clinical efficiency of Subetta in the combined treatment of type II diabetes~          mellitus;~        -  to assess safety of Subetta in the combined treatment of type II diabetes mellitus.~   "
90806|NCT01868633|"~     The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when~     used as part of a multimodal regimen to manage post cesarean delivery pain.~      We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal~     analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid~     consumption and pain~   "
90807|NCT01868620|"~     The primary purpose of the protocol is to compare the current standard CXL with~     iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive~     keratoconus.~      Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the~     progression of keratoconus. In the current standard CXL, the central corneal epithelium must~     be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium~     debridement can cause severe pain, infection and stromal haze. The study hypothesis is that~     iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.~   "
90808|NCT01868607|"~     The objective of the study is to evaluate the reliability of the impedance data in adult~     subjects measured with five different FOT devices.~   "
90809|NCT01868594|"~     The purpose of this study is:~        -  to assess clinical efficiency of Subetta in the combined treatment of type I diabetes~          mellitus;~        -  to assess safety of Subetta in the combined treatment of type I diabetes mellitus.~   "
90810|NCT01868581|"~     This trial is conducted i Europe. The aim of this trial is to test for bioequivalence~     between two explorative formulations of insulin degludec (insulin 454) and between two~     explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with~     or without buffer, in healthy male subjects. The investigated formulations are explorative,~     not similar to the proposed commercial formulation.~   "
90811|NCT01868568|"~     This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and~     insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of~     insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30~     (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to~     four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high~     concentration were explorative formulations, not similar to the proposed commercial~     formulation.~   "
90812|NCT01868555|"~     This trial is conducted in Asia. The aim of this trial is to assess the safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of two insulin degludec/insulin aspart~     (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy~     Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative~     formulations, not similar to the proposed commercial formulations.~   "
90819|NCT01868464|"~     This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a~     challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the~     target population reflecting the community at large at 2 VTEU sites. It is anticipated that~     enrollment will occur over a 14-month period. Subjects who provide informed consent will be~     considered for eligibility (screened), and up to 120 eligible, willing, healthy, HIV and TB~     uninfected subjects aged 18 to 45 years, inclusive, will be enrolled for study interventions~     and sequentially assigned to 1 of 4 dose groups. Dose titrations of Tice® BCG from 2x10^6~     cfu to 16x10^6 cfu will be delivered intradermally in a dose escalation format to 4 groups~     of 30 subjects per dose group.~   "
90820|NCT01868451|"~     The purpose of this study is to compare the outcomes across the 4 different treatment~     groups. The investigators hope that this treatment will improve the ability to cure more~     patients with HL and also limit the long-term side effects from the treatment. Although~     eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from~     radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased~     risk of the Hodgkin lymphoma coming back after initial treatment.~   "
90821|NCT01868438|"~     The purpose of this study is to compare the bioavailability of two formulations (tablets and~     granules for dispersion) of the antimalarial drug Pyramax (which is a combination of~     pyronaridine and artesunate).~   "
90822|NCT01868425|"~     This study will evaluate the effectiveness of an aggressive multimodal regimen versus~     standard multimodal for ACL repair using hamstring graft for patients having surgery in our~     outpatient surgicenter.~   "
90823|NCT01868412|"~     In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey~     from manuka myrtle (Leptospermum scoparium), has successfully been used in medical context~     to treat both acute and chronic surgical wounds. The objective of this prospective,~     randomized and controlled clinical trial is to investigate healing rate and healing time of~     surgical wounds in patients, who have undergone peripheral vascular surgery, and whose~     complicated wounds are candidate for topical treatment with the resin or honey. In addition,~     factors contributing with delayed wound healing, antimicrobial properties, safety and~     cost-effectiveness of the resin salve and medical honey will be analyzed.~   "
90824|NCT01868399|"~     Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the~     medical service for people in Solomon Islands thru Taiwan Health Center at the local. In~     addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus,~     Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic~     infections might be the existing but overlooked and neglected medical issues in Solomon~     Islands. These infections show similarity in clinical manifestations and usually difficulty~     in clinical diagnosis, instead these infections rely on the laboratory identification with~     good laboratory quality and facility.~   "
90825|NCT01868386|"~     Radiation therapy is one of the standard treatments for men with prostate cancer who have~     detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker)~     after surgery. When radiation therapy is given to patients who have an increase in PSA after~     surgery, it is called salvage radiation therapy. Currently the standard radiation therapy~     course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy~     after prostate removal causes unpleasant side effects. A shorter course of radiation~     therapy, known as a hypofractionated course, gives fewer but higher doses of radiation~     than standard radiation.~      The purpose of this study is to test the safety of a shorter course of radiation therapy at~     progressively lower dose levels and shorter lengths of treatment (hypofractionated) with~     patients who have had their prostate removed. The study will assess whether the~     hypofractionated course works better without causing additional side effects to the~     remaining cancer cells in the prostate bed.~   "
90826|NCT01868373|"~     To confirm and extend the work of Trede and Rask-Madsen (Lancet 1989;1:1156-1160) that~     administration of a defined fecal microbiota will lead to rapid and sustained resolution of~     C. difficile associated chronic relapsing diarrhea.~      The current rationale behind FMT for CDI is that introduction of microbes from a healthy~     donor allows restoration of a normal microbial community in the diseased host with~     consequent suppression of C. difficile colonization and disease pathogenesis. The first~     modern use of FMT was reported in a 1958 case series of 4 patients with pseudomembranous~     enterocolitis. The first case of confirmed CDI treated with FMT was reported in 1983;~     treatment was curative. Until 1989, retention enemas were the most common technique for FMT.~     Alternative methods for delivering FMT have included fecal infusion via duodenal tube~     (1991), rectal tube (1994), and colonoscopy (1998). FMT for recurrent CDI has been used~     successfully whether administered by nasogastric tube, rectal administration by colonoscopy,~     rectal tube including self-administration at home by enema. FMT has proven to be remarkably~     effective and remarkably safe without any significant problems (see below and attached~     reviews and meta-analyses).~      Increasing, interest is emerging regarding the changes in the intestinal microbiota~     associated with CDI. In 2008 Chang et al. constructed small (< 200 sequences per subject)~     16S rRNA gene libraries from the stools of 4 patients with first-time CDI and 3 patients~     with recurrent CDI. Based on 16S rRNA gene classification, they found that the fecal~     microbiomes of patients with an initial episode of CDI were similar at the phylum level to~     healthy subjects (i.e., the majority of sequences belonged to dominant fecal phyla~     Bacteroidetes and Firmicutes), while a major reduction or loss of Bacteroidetes was observed~     in patients with recurrent CDI. The loss of the Bacteroidetes was accompanied by the~     expansion of other phyla, including Proteobacteria and Verrucomicrobia, which are normally~     minor constituents of the fecal microbiota. Khoruts et al. (2010) compared the microbiota of~     a patient with recurrent CDI before and after FMT by using terminal-restriction fragment~     length polymorphism and clone-based 16S rRNA gene sequencing. Before transplantation, the~     patient's microbiota were deficient in members of Bacteroides and instead were composed of~     atypical fecal genera such as Veillonella, Clostridium, Lactobacillus, Streptococcus, and~     unclassified bacteria similar to Erysipelothrix. Two weeks after infusion of donor fecal~     suspension, the bacterial composition of her feces approached normal and was dominated by~     Bacteroides sp. strains.~      In 1989, Tvede and Rask-Madsen used a combination of nine normal fecal organisms to treat 6~     patients with chronic relapsing C. difficile diarrhea. These investigators cultivated 10~     strains of bacteria, including Enterococcus (Streptococcus) faecalis (1108-2), Clostridium~     innocuum (A27-24), Clostridium ramosum (A3I-3), Bacteroides ovatus (A40-4), Bacteroides~     vulgatus (A33-14), Bacteroides thetaiotaomicron (A33-12), Escherichia coli (1109), E. coli~     (1108-1), Clostridium bifermentans (A27-6), and Blautia producta (Peptostreptococcus~     productus) (1108-2) in broth for 48 h to a concentration of approximately 10 to the 9th~     power bacteria/mL. Two mL from each bacterial culture were admixed with 180 mL saline that~     had been pretreated in an anaerobic chamber for 24 h; the bacterial suspension was then~     instilled rectally. This procedure was followed promptly by a decline of C. difficile to~     undetectable levels by culture and the loss of detectable toxin from the stools. Normal~     bowel function was restored within 24 hours, and abdominal symptoms disappeared. Stool~     cultures and toxin assays for C. difficile remained negative during a year of follow-up. It~     is especially important to note that feces from none of the 6 patients contained Bacteroides~     sp.~   "
90827|NCT01868360|"~     The cornea is the clear front part of the eye. Corneal neovascularization, the excessive~     growth of blood vessels into the cornea, is a sight-threatening condition. Corneal~     neovascularization is also a well recognized risk factor for corneal graft failure. The~     current standard of care to prevent graft rejection includes use of topical steroids and~     medicines that suppress the immune system. These medicines do not address corneal~     neovascularization. The purpose of the study is to establish the safety and potential~     efficacy of subconjunctival injections of aflibercept (EYLEA® , marketed by Regeneron)~     injection in inducing regression of blood vessels growing into the cornea and promoting~     graft survival.~      This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center.~   "
90828|NCT01868347|"~     Analysis of the specific elastance during general anesthesia in patients treated with RARP~     (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive~     strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of~     pneumoperitoneum and trendelenburg position.~   "
90829|NCT01868334|"~     The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult~     Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and~     acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed~     vaccines and to be used according to national guidelines. The investigators will conduct a~     randomized cluster trial of this toolkit in diverse primary care practice with electronic~     medical records (EMRs).~   "
90830|NCT01868321|"~     The purpose of this international, multicenter study is to determine ventilation practice~     and outcomes of intubated and ventilated intensive care unit (ICU) patients. Ventilation~     characteristics and outcomes will be compared between patients without the acute respiratory~     distress syndrome (ARDS), patients at risk for ARDS, and patients with mild, moderate or~     severe ARDS.~      Participating centres worldwide will include adult patients undergoing mechanical~     ventilation in the ICU during a 7-day period. Patients data will be collected during the~     first 7 days in the ICU, or until ICU discharge. Follow up is until day 90. Primary endpoint~     is the tidal volume size used during mechanical ventilation. Secondary endpoints are~     development of ARDS in patients without ARDS at the onset of mechanical ventilation,~     worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary~     infection, other pulmonary complications, need for tracheostomy, extra-pulmonary~     complications, duration of ventilation, length of ICU and hospital stay, and ICU, hospital~     and 90-day mortality.~   "
90832|NCT01868295|"~     Tooth loss and sleep problems are common conditions in elders. Tooth loss can influence~     sleep quality by changing the shape of the lower face and upper airway. While some studies~     suggest that sleeping without dentures can worsen sleep quality in toothless elders, others~     suggest the opposite. Consequently, there are currently no evidence-based practice~     guidelines regarding whether dentures should be used at night, and dentists and doctors do~     not know how to properly advise their patients on these issues. To address this knowledge~     gap, over the past 5 years we have carried out research examining the quality of sleep of a~     group of edentulous elders. In addition, we conducted a pilot study to examine the link~     between night-time denture wear and sleep. Our results indicate that edentulous elders who~     wore their dentures at night had high levels of daytime sleepiness. Furthermore, use of~     dentures at night seemed to increase the risk of apneic events in those elders who had mild~     sleep disturbance. While intriguing, these results require confirmation in larger samples.~     In line with our previous research, the aim of the proposed study is to produce reliable~     evidence that clinical practice guidelines could be based on and which could be used by~     dentists and doctors who treat toothless elders.~      We will enroll 70 toothless elders who will be randomly assigned to wear and not wear their~     dentures at night for two periods of 30 days. Sleep studies will be conducted at the homes~     of participants. The participants will also be asked to respond to questions on sleep~     quality and oral health-related quality of life. Ultimately, the results of this study will~     help improve the health and quality of life of millions of elders in Canada and around the~     world.~   "
90833|NCT01868282|"~     Patients scheduled to undergo knee arthroscopy with anterior cruciate ligament repair with~     graft from the ipsilateral hamstrings and gracilis will be randomized to one of three~     groups. All patients will receive subsartorial saphenous nerve block. Along with this, Group~     1 will receive perihamstring local anesthetic infiltration (Hamstring block), Group 2 will~     receive blockade of the anterior division of obturator nerve and Group 3 (control group)~     will receive sham injections of hamstrings and anterior division obturator nerve. All~     patients will receive co-analgesics for home discharge. The study will evaluate the efficacy~     of subsartorial saphenous nerve block alone or in combination with either hamstring block or~     obturator block with regards to postoperative analgesia especially the donor site pain and~     total analgesic consumption.~   "
90834|NCT01868269|"~     The OMS/DES study is a multinational European Trial for Children with the Opsoclonus~     Myoclonus Syndrome / Dancing Eye Syndrome.~      This trial brought on the way by specialists of the EPNS (European Paediatric Neurology~     Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN~     (SIOP (International Society Oncology Pédiatric) Europe Neuroblastoma).~      This protocol will investigate an escalating treatment schedule starting with a~     corticosteroid standard treatment with dexamethasone pulses (first step), which is followed,~     if response has been inadequate after 3 months of treatment, by the addition of CP (second~     step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third~     step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES~     severity.~   "
90835|NCT01868256|"~     -  Objectives: The primary objective of this study is to evaluate the safety of an early~          discharge strategy in patients with low risk ST-elevation myocardial infarction~          (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a~          conventional strategy.~        -  Methodology: Unicentric, randomized, controlled, non-inferiority and open label~          clinical trial. The investigators will compare an early discharge strategy (≤72 hours)~          with a conventional strategy (discharge according to treating physician's criterion).~          Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI~          within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias~          (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity,~          advanced atrio-ventricular block), mechanical complications (cardiac tamponade,~          free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or~          moderate bleeding (according to the GUSTO criteria), complications related to vascular~          access of the procedure, acute kidney failure, infection, heart failure. Sample size~          will be 1558 subjects (n=779 per group). The investigators will study demographic,~          clinical, biochemical, echocardiographic and angiographic variables. The primary~          endpoint will be a composite of death, reinfarction, new angina, heart failure,~          ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will~          include each of the items of the primary endpoint and quality of life and functional~          capacity questionnaire SF-36. Finally, the investigators will analyze the degree of~          compliance with the European Society of Cardiology guidelines on STEMI and the rate of~          hospitalization-related complications. Follow up will be at 30 days.~   "
90836|NCT01868243|"~     DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be~     observed in this study is intracardiac thrombus. There are no formal primary or secondary~     clinical efﬁcacy or safety outcomes because it is a pilot study.~   "
90837|NCT01868230|"~     The overall goal of this randomized controlled trial is to test the efficacy of a culturally~     and linguistically modified, individually tailored lifestyle intervention to reduce excess~     gestational weight gain (GWG), increase postpartum weight loss, and improve maternal~     metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the~     impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum~     biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin),~     3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4)~     offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and~     5) to evaluate the cost-effectiveness of the intervention per average incremental~     improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in~     early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention~     (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention~     will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549)~     culturally adapted for Hispanics and shown to be efficacious in our previous controlled~     trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and~     mailed print-based materials) will be used to deliver the intervention during pregnancy (~12~     wks gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum);~     follow-up will continue for one year postpartum. Targets of the intervention are to achieve~     Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for~     physical activity through increasing walking and developing a more active lifestyle; and~     reduction in total calories by following a balanced healthy diet in compliance with American~     Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the~     Transtheoretical Model and includes strategies for partner and/or family support to address~     the specific social, cultural, and economic challenges faced by underserved Hispanic women.~     Measures of compliance will include actigraphs and Hispanic food frequency questionnaires.~     The proposed project builds upon the expertise of the investigative team in conducting~     randomized controlled trials of exercise interventions among Hispanic pregnant women (R01~     DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18~     DK0658850) and can readily be translated into clinical practice in underserved and minority~     populations.~   "
90838|NCT01868217|"~     -  To Investigate the Prevalence of Capsular Bag Distention Syndrome~        -  To Analyze Influencing Factors of Capsular Bag Distention Syndrome~   "
90880|NCT01867671|"~     This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut~     oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in~     peanut-allergic children. Eligible participants with peanut allergy will be randomly~     assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance~     for 26 weeks.~   "
90839|NCT01868204|"~     Adoption, twin and family studies have reported that obesity has a strong heritable~     component and in particular, it has been suggested that BMI in adults is due to genetic~     influence rather than shared family environment. Binge eating in obese patients was~     described. Therefore, it has been proposed that binge eating disorder (BED) may contribute~     to obesity in some individuals.~      Pharmacological studies reported that topiramate plays an important role in the treatment of~     binge eating disorder. It has been observed improvement of co-occurring binge eating~     disorder in patients receiving topiramate for treatment of mood disorders. In addition,~     topiramate was associated with anorexia and weight loss in clinical trials with epilepsy~     patients. Also, topiramate has been demonstrated efficacy in pilot and controlled studies~     for binge eating disorder (BED) associated with obesity. Genetic studies will be important~     to elucidate the mechanism by which putative susceptibility variation in candidate genes~     influences in pharmacological improvement of binge eating disorder in obese patients treated~     with topiramate.~      Connecting drug response with relevant functional DNA variants and differences in brain~     regions represents the ultimate goal for pharmacogenetic research playing an important role~     in advancing this understanding. The use of brain imaging combined with genetics can aid in~     understanding the pathophysiological mechanism of the disease. Additionally, brain imaging~     has the ability to bridge between preclinical research and human pharmacological studies.~      This will be a naturalistic clinical study designed to analyze the effect of genetic~     variants and neurofunctional brain areas associated with food craving in patients with~     obesity and binge eating disorder responders to topiramate.~      Hypothesis: The use of topiramate in obese subjects with binge eating disorder is associated~     with a differential gene variants and different activation brain areas in subjects that~     showed a reduction of food craving and weight lost.~   "
90840|NCT01868191|"~     The aim of the present study is to assess before, as well as 6 and 12 months following a~     therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density~     (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes~     mellitus and diabetic sensomotoric neuropathy.~   "
90841|NCT01868178|"~     The aim of this study was to estimate the relationship between BIS and Spectral Entropy~     values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.~   "
90842|NCT01868165|"~     Older adults are at increased risk of high blood pressure and cognitive decline. High blood~     pressure itself also increases risk of cognitive decline. A particular type of blood~     pressure lowering drug (a calcium channel blocker(CCB)) may lower risk of dementia in~     younger adults but there is no clear evidence of it's impact in those >=80. It is important~     that we know whether CCB use impacts on cognitive function in this age group. This study~     will compare change in cognitive function in those taking CCBs to those not taking CCBs.~   "
90843|NCT01868152|"~     This study aimed to find a quick and timely way to predict the individual variation of~     efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese~     patients undergoing elective surgeries. Methods: female patients receiving elective surgery~     under general anesthesia were recruited into this study. At the time of routine intravenous~     anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect,~     effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo~     effects on cardiovascular system. Then we record the consumption of of opioid analgesic~     during the operation and postoperative analgesia. Also we record the side effect of the~     opioid analgesic.~   "
90844|NCT01868139|"~     The goal of this study is to evaluate the safety and efficacy of endoscopic spray~     cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously~     untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy~     including surgery, chemotherapy, radiation therapy, and endoscopic resection.~      It is hypothesized that one of the two following outcomes will occur:~        1. Complete response to therapy: complete tumor eradication confirmed through histologic~          examination of biopsy specimens from the targeted esophageal tissue site;~        2. Stable disease: tumor remission is not attained, but disease progression is halted.~   "
90845|NCT01868126|"~     The purpose of this study is to investigate the safety and efficacy of four concentrations~     of DE-117 ophthalmic solution.~   "
90846|NCT01868113|"~     The purpose of this study is to find out whether adjunct treatment with inhaled~     corticosteroids lead to faster improvement and reduce mortality of children under 5 years of~     age admitted to hospital with ALRI.~   "
90847|NCT01868100|"~     Advanced cancer has an adverse effect in virtually all dimensions of patients' lives~     (physical, psychosocial, spiritual, familial, role function). One of the less frequently~     explored effects of cancer is its impact on personal finances and the contribution of~     financial-related distress to overall suffering and quality of life. Financial issues have~     been recently found to be the second most frequent source of distress identified by cancer~     patients in a community cancer center context (22%).~      In the context of continuous increased health care costs, it is likely that the frequency of~     health care related financial problems will keep rising. The relative contribution of these~     adverse financial events in advanced cancer patients to overall patient distress is not well~     assessed and this is particularly true in France. The main objective of this work is to~     determine the association between financial distress and quality of life of patients with~     advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A~     secondary objective is to characterize the frequency and intensity of financial distress~     reported by French cancer patients and their impact on their quality of life.~   "
90848|NCT01868087|"~     The purpose of this study is determine if using Impact Advanced Recovery® before and after~     RC surgery helps reduce surgical complications.~   "
90849|NCT01868074|"~     This research is being conducted to determine whether use of an arch-supporting insole~     during pregnancy prevents alterations in foot structure and lower limb rotational movements.~     The investigators hypothesize that the arch collapse during pregnancy will be significantly~     reduced in women randomized to use the supportive insole compared with women randomized to~     the control group.~   "
90850|NCT01868061|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease~     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and~     at least one second controller medication. Participants will be randomized in 1:1:1 ratio to~     receive double-blind treatment with either lebrikizumab (high or low) or placebo,~     administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their~     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment~     extension. Participants who were assigned to placebo during the placebo-controlled period of~     the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5~     milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study~     treatment is 104 weeks. After study treatment, all participants will complete a 20-week~     safety follow-up.~   "
90851|NCT01868048|"~     The purpose of this study is to determine the effective dose range and to demonstrate a~     non-effective dose range of Sativex compared with placebo in relieving symptoms of~     spasticity due to multiple sclerosis.~   "
90852|NCT01868035|"~     This is a multicenter study for the long-term follow-up of surviving patients who are~     expected to complete or who have completed at least two years of follow-up after treatment~     with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or~     CP-99-036. All patients will be assessed for survival and disease status, including~     subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term~     safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone~     (TSH) level and a complete blood cell (CBC) count with a differential and platelet count~     will be obtained annually. Additionally, patients who remain in long-term response following~     Iodine I 131 Tositumomab treatment will be followed for response and progression.~   "
90853|NCT01868022|"~     This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with~     malignancies with abnormal dependence on FGF pathway signaling. Combination doses of~     GSK3052230 with standard of care chemotherapy in the first and second line or greater~     setting of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant~     pleural mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will~     be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase~     IB study designed to evaluate the safety, tolerability and preliminary activity of~     GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with~     docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70~     subjects will be enrolled in the study (approximately up to 120 may be enrolled).~   "
90854|NCT01868009|"~     Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months~     will be screened to participate in the study. Subjects will have an equal chance of being in~     any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA~     inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the~     DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The~     other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period~     (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second~     period (once daily for 5 to9 days). At the end of the second period, subjects will complete~     the study by answering 7 questions to assess their preference of device attributes and~     dosing regimens between the two inhalers.~      The null hypothesis for device preference for a specific attribute is that 50% subjects~     express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in~     that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA~     is unity.~      The null hypothesis for dosing regimen preference is that 50% subjects express a preference~     of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice~     daily dosing or have no preference).~   "
90855|NCT01867996|"~     This will be a randomized single sequence open label study. This study is designed to~     determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics~     (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of~     screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and~     the total duration of study participation for each subject will be approximately 8 weeks.~     During the treatment period, subjects will be admitted to the clinical research unit the day~     before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All~     subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min),~     followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On~     Days 3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects~     will receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs~     plus a 600 mg dose of EFZ.~   "
90856|NCT01867983|"~     This randomized controlled trial compares the effectiveness for both smoking cessation and~     weight control of two alternative combined interventions offered via telephone quitline, as~     compared to standard of care quitline treatment addressing cessation alone. The~     interventions to be compared are cessation treatment alone versus cessation treatment~     combined with weight control treatment added either simultaneously or sequentially.~   "
90857|NCT01867970|"~     Rationale: Physical activity is an important factor for a healthy lifestyle. Although~     physical activity can delay complications and decrease the burden of the disease in~     chronically ill persons, their level of activity is often far from optimal. Many~     interventions have been developed to stimulate physical activity, with disappointing~     results. New in this field is the use of technology. Human persuasion (for example guidance~     by a practice nurse) can be enhanced by technological persuasion. Therefore a monitor and~     feedback tool, consisting of an accelerometer linked to a smart phone and webserver, has~     been developed and tested.~      Objective: The main objective of this study is to measure the effects of the monitoring and~     feedback tool embedded in a Self-management Support Program on physical activity. The~     secondary objective is to measure the effect on self-efficacy, quality of life and health~     status. In addition a process evaluation will be conducted.~      Study design: A three-armed cluster randomised controlled trial will be conducted with 240~     patients from 24 general practices. Randomisation level is the practice. The following~     conditions will be compared: 1) Tool and Self-management Support Program; 2) Self-management~     Support Program; 3) Care as usual. Outcome measures will be measured at t0 (before the start~     of the intervention), t1 (after 6 months, at the end of the intervention) and t2 (after 9~     months).~      Study population: 120 People with COPD and 120 people with Diabetes type 2 (aged 40-70)~     treated in primary care will be included from 24 GP practices.~      Intervention: Spread over a period of six months patients in condition 1 and 2 have to visit~     the practice nurse for 3-4 times for physical activity counselling. Specific activity goals~     will be set that are tailored to the individual patient's preferences and needs. On top of~     this, patients in condition 1 will be instructed to use the monitoring and feedback tool in~     daily life. Patients in condition 3 will not be exposed to any intervention.~      Main study parameters/endpoints: Primary outcome: physical activity measured with a physical~     activity monitor (PAM). Secondary outcomes: quality of life, general self-efficacy, exercise~     self-efficacy and health status.~   "
90858|NCT01867957|"~     1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and~          effective in preclinical studies.~        2. OBJECTIVE~           - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy~          male volunteers.~        3. STUDY DESIGN~             -  single-blinded~             -  randomized~             -  placebo controlled~             -  phase 1 study~   "
90859|NCT01867944|"~     The primary aim of this study is to test a non-medicinal technique for chronic constipation.~     The core of the technique is to have subjects repeatedly press on and massage their perineum~     before defecation to fragment and soften the stool before it passes the lower rectum and~     anus. The technique will be evaluated as a complementary treatment to standard treatment of~     constipation (patient educational materials about treatments such as stool softeners,~     laxatives fiber supplements, and increased exercise). Although this technique has been~     studied for other conditions (for example in pregnant women to prevent birthing-related~     injuries), and it is recommended anecdotally by some physicians, this would be the first~     time it will be studied for chronic constipation in a randomized, controlled clinical trial.~      $50 dollars in compensation is provided for about an hour of participant's time.~   "
90861|NCT01867918|"~     In this study the investigators will include colo-rectal cancer (CRC) patients starting last~     line of standard palliative chemotherapy. Eligible patients include patients with KRAS~     mutation starting line or KRAS wild type starting line treatment. Standard treatment today~     for these patients is chemotherapy only and median overall survival (OS) is about 10 months.~     The hypothesis is that local treatment in addition to systemic treatment will increase time~     to progression, progression free survival and overall survival compared to patients who~     receive systemic chemotherapy only. The investigators experience with local treatment of~     liver metastases in CRC patients is that side-effects of treatment in general are minor,~     although gastric bleeding have been observed after stereotactic body radiation therapy.~   "
90862|NCT01867905|"~     Sepsis is a significant cause health care expenditure and carries an extremely high rate of~     morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in~     over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to~     27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was~     103.3 per 100,000 per year.~      Advances in the multifaceted management of sepsis in recent years have resulted in improved~     clinical outcomes. However, the cornerstone of sepsis management relies on the prompt~     administration of appropriate antibiotics. Current clinical practice suggests that~     antibiotic administration can be delayed up to 45 minutes in order to obtain blood cultures,~     whose results have a profound impact on the type and duration of antimicrobial therapy.~     Unfortunately, this recommendation is based on very little evidence and the investigators~     have found that potential life-saving treatment is often delayed in order to abide by it.~     Furthermore, recent data suggest that mortality could be increased by approximately 5% by~     delaying antibiotic administration for that time period.~      The investigators therefore wish to organize a prospective, multi-centre trial in order to~     identify the effect of antibiotic administration on blood culture positivity in patients~     presenting with severe sepsis or septic shock. Other objectives will be to elucidate which~     patient factors, including age, co-morbid conditions and clinical presentation, as well as~     antibiotic choice will affect blood culture results.~      This study will be conducted in the emergency departments at St. Paul's Hospital (SPH),~     Vancouver General Hospital (VGH), and Lion's Gate Hospital (LGH). Patients identified for~     the aforementioned conditions will be treated as per routine hospital protocol. If the~     patient is deemed eligible for the study, a second set of blood of blood cultures will~     subsequently be drawn ideally between 30 and 60 minutes after the administration of~     antibiotic therapy. Subject demographic data will be collected pertaining to age, comorbid~     immunocompromised conditions, vital signs, laboratory tests pertaining to end organ~     dysfunction, suspected source of sepsis, the type antibiotics administered and the timing of~     antimicrobial administration with respect to the second set of blood cultures taken.~      Our hypothesis is that blood culture positivity in patients presenting with severe sepsis~     and septic shock will not be altered significantly by antibiotic therapy. If so, our study~     would strongly argue against delaying life-saving therapy and would thus greatly improve~     patient care in our local emergency rooms. If incorrect, our study would be the first to~     demonstrate the benefit of obtaining blood cultures before antibiotic therapy and would~     strengthen current recommendations.~   "
90863|NCT01867892|"~     The primary end point is to evaluate the 9-month progression free survival rate and safety~     profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent~     chemoradiotherapy in locally advanced pancreatic cancer.~      The secondary end points are to evaluate the disease control rate, overall survival time,~     toxicity profile and compliance after induction chemotherapy and concurrent~     chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone~     in locally advanced pancreatic cancer. Translational research including pharmacogenomic~     study and biomarker study will also be done concomitantly.~   "
90864|NCT01867879|"~     The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with~     advanced solid tumors.~   "
90865|NCT01867866|"~     The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as~     a component of TAS-102 with FTD alone.~   "
90866|NCT01867853|"~     To evaluate the performance of volume responsiveness in predicting the outcome of mechanical~     ventilation weaning in critically ill patients.~   "
90867|NCT01867840|"~     In recent years, ion channels have emerged as new therapeutic targets for pain. Among these~     channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are~     directly activated by extracellular acidity, which is a major cause of pain. Indeed, many~     painful conditions such as ischemia, inflammation, tumor development or tissue incision are~     accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in~     neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a~     nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain~     induced by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates~     capable of mediating pain in humans. A growing number of data suggests that, in addition to~     protons, ASICs may also be activated by one or more endogenous compounds produced during~     inflammation. The purpose of this research project is to identify these compounds by testing~     the effects of human inflammatory exudates on ASICs activity. The discovery of such~     compounds would definitely validate ASICs as novel therapeutic targets for pain treatment in~     humans~   "
90868|NCT01867827|"~     The aim of the study is to train patients with Parkinson's Disease to increase activity in a~     brain area that is involved in the control of motor functions with the use of a technique~     called real-time fMRI neurofeedback (NF) along with regular physical exercise. This will be~     a randomised and controlled clinical trial to evaluate the benefits of a novel treatment.~     The investigators expect NF training along with physical exercise practise to better improve~     motor functions compared to physical exercise alone.~   "
90869|NCT01867814|"~     Laparoscopic surgery is frequently associated with hemodynamic changes due to~     pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and~     occasionally they require active therapeutic interventions or even interruption of the~     surgical procedure.~      One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction~     of venous return and cardiac preload. Although it has been shown repeatedly that waveform~     variables are good predictors of cardiac output response to volume loading, the prediction~     hemodynamic response to decrease of preload is more complex.~      The investigators hypothesize that waveform variables will predict cardiac output changes~     resulting from PnP. Particularly, augmented values of waveform variables before PnP will be~     associated with a larger decrease of cardiac output after establishing PnP.~   "
90870|NCT01867801|"~     The purpose of this Registry is creating a database management that allows continuous~     monitoring characteristics, evolution, prognostic indicators and management of patients~     undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of~     clinical and interventional practice recommendations for diagnosis and treatment of coronary~     disease and monitoring its evolution.~   "
90881|NCT01867658|"~     The objective of this clinical study is to evaluate the safety of the Progel® PALS,~     including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative~     air leaks in patients undergoing video assisted or robotic assisted thoracoscopic~     (VATS/Robotic) surgeries.~      The data collected in this clinical study will supplement the Approved PMA P010047 Progel®~     PALS product.~   "
90871|NCT01867788|"~     The Harvard Biomarker Study is a Harvard-wide, longitudinal case-control study designed for~     discovering, replicating, and developing biomarkers for Parkinson's disease and Alzheimer's~     disease. High-quality biosamples and high-resolution clinical phenotypes are tracked at~     three visits over a two-year period for more than 2,000 individuals with early-stage PD,~     MCI/AD, and controls without neurologic disease.~      The present Ancillary Longitudinal CSF Collection Study (short HBS2) is an ancillary study~     to the parent Harvard Biomarker Study. HBS2 is funded by the NINDS. In HBS2, 75 participants~     are more intensely studied and followed over a three-year time period. Clinical data and~     blood biospecimens are collected every six months and four annual CSF collections are~     performed. Biospecimens and clinical data are deposited into the NINDS PD Biomarkers Program~     (PDBP) Repository and the Data Management Resource (DMR) and are accessible through the PDBP~     DMR website.~   "
90872|NCT01867775|"~     The purpose of this study is to determine whether mirtazapine is effective in the treatment~     of sleep disorders in Alzheimers disease.~   "
90873|NCT01867762|"~     The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in~     participants with symptomatic moderate to severe chronic obstructive pulmonary disease~     (COPD).~   "
90874|NCT01867749|"~     The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who~     meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to~     demonstrate the feasibility of the proposed recruitment methods and research design, of the~     therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group~     treatment.~      The investigators would like to examine preliminary evidence for the following hypotheses:~        -  Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD~          following perinatal loss than will Coping with Depression (CWD).~        -  Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and~          reduced depressive symptoms relative to CWD.~        -  Perinatal-loss specific IPT-G will result in increased social support and social~          functioning, reduced couple distress, and reduced grief relative to CWD.~   "
90875|NCT01867736|"~     A prospective, multicentric, randomized controlled trial to assess the safety and~     performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the~     uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or~     occlusion of the infrapopliteal arteries.~   "
90876|NCT01867723|"~     Being diagnosed and treated for cancer is usually associated with severe side effects and~     symptoms. Cancer patients can have difficulty to manage the symptoms as a result of~     treatment which may cause i) an interruption or cessation of cancer treatment ii) can have a~     negative impact on patients' quality of life (QoL). Family caregivers (FCs) of cancer~     patients are often the primary source of social and emotional support for patients, and play~     major roles in how well patients manage with the consequences of illness and treatment.~     Thus, FCs are clinically important, since supporting FCs indirectly supports patients.~      To help both cancer patients and their FCs to manage their symptoms, our center has~     developed WebChoice now called Connect, an internet based support system that extends~     traditional health services into cancer patients' homes. Connect provides individualized~     symptom management support, illness relevant information, and communication with a clinical~     nurse specialist in cancer care, as well as with other cancer patients and their FCs over~     the Internet. The objectives of this interdisciplinary research project are to test main and~     interaction effects of providing Connect to patients, to FCs or both simultaneously on 1)~     primary patient outcomes in terms of symptom distress, QoL, depression, fatigue and sleep 2)~     Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and FC~     burden 3) Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy~     social support, and self-reported health care utilization.~   "
90877|NCT01867710|"~     The purpose of the study is to determine the safety and clinical benefit of the combinations~     of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer~     patients. Prednisone will be given at one of three different dose schedules. Dexamethasone~     will be given at one dose schedule. This will include looking at what side effects occur and~     how often they occur. In addition the impact of the study drug on quality of life and pain~     will be evaluated. The study will also collect data on subsequent treatment of patients~     after they come off the study drug (up to a maximum of 5 years after the study starts). By~     analyzing blood samples, the study aims to identify if some markers could help to understand~     if the treatment with abiraterone is effective and also help to understand if patients can~     become resistant.~   "
90878|NCT01867697|"~     Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating~     FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in~     patients with potential resectable KRAS wildtype metastatic colorectal cancer.~      All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A)~     FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46~     hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6~     (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours~     5FU infusion of 2400 mg/m2 every 2 weeks) .~      Primary objective: response rate (RECIST 1.1) in patients with with potential resectable~     KRAS wildtype metastatic colorectal cancer.~      Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker~     evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will~     be collected to search for markers that may predict efficacy including respectability and~     safety.~   "
90879|NCT01867684|"~     Stroke, head injury and other forms of brain injury are a major cause of physical,~     psychological and social disability in the adult population. Psychological distress is~     common following brain injury, but the evidence base for specific psychotherapeutic methods~     in this population is limited, and standard treatment approaches may not be suitable.~     Recently there has been a growing interest in positive psychology - the study of wellbeing,~     positive emotions and characteristics, and personal growth. The investigators believe that~     positive psychotherapy interventions may be beneficial after acquired brain injury, to~     reduce psychological morbidity. Because such interventions have not previously been applied~     in this population, the investigators propose to conduct a pilot randomised controlled trial~     to examine the feasibility of a brief positive psychotherapy intervention in an out-patient~     setting. This project will produce essential information to allow us to plan future~     full-scale clinical trials in this area.~   "
90884|NCT01867619|"~     The primary objective of the phase II study is to assess the objective (CR+PR) response rate~     at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and~     Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the~     brain. Secondary objectives include the evaluation of objective response in the extracranial~     metastases, duration of response and overall survival.~   "
90885|NCT01867606|"~     This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein~     isolate works in improving quality of life and post-operative recovery in patients with~     cancer of the female reproductive tract after undergoing surgery. Serum bovine~     immunoglobulin may help provide nutrition to patients who are not able to eat or digest~     ordinary food. This may improve the quality of life of patients with gynecological cancer~     and help them recover more quickly from surgery.~   "
90886|NCT01867593|"~     This research study is a prospective pilot study. The purpose of a pilot clinical study is~     to obtain preliminary data to support the reason for doing a larger clinical trial on~     testing the clinical effectiveness of an investigational intervention. Investigational~     means that the role of MET-PET scans is still being studied and that research doctors are~     trying to find out more about it. It also means that the FDA has not approved this~     intervention for your type cancer.~      In this research study, the investigators are evaluating whether or not MET-PET scans have~     value in predicting response to standard chemoradiation therapy in participants with~     newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a~     combination of radiation therapy and chemotherapy with the drug temozolomide.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells. With standard PET scans, the~     radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it~     difficult for use in distinguishing brain tumors from normal tissue.~      For the PET scans in this research study, the investigators are using a radioactive~     substance called MET, instead of the standard substance FDG. MET gets absorbed by cancer~     cells but not by normal brain and therefore may be better than FDG in evaluating brain~     tumors and therefore may be better than FDG in evaluating brain tumors and their response to~     treatment.~      In this research study, participants will receive standard chemotherapy and radiation~     therapy for glioblastoma as well as standard MRI scans. In addition, participants will~     undergo L-[Methyl]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The~     first MET-PET scan will occur after enrollment but prior to radiation therapy. The second~     MET-PET scan will occur approximately one month after completion of radiation therapy.~   "
90887|NCT01867580|"~     The purpose of this study is to examine the effectiveness of the V.A.C.Ulta Negative~     Pressure Wound Therapy System and V.A.C. VeraFlo Dressing System in wounds that require~     operative debridement.~   "
90888|NCT01867567|"~     Women undergoing their first second or third cesarean section will be randomized into two~     groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the~     other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days~     for both groups. The incision will be inspected at the time of staple removal. The 2 groups~     will be compared for incision disruption and infection. Also, the women will be asked about~     their satisfaction for time of bandage removal.~   "
90889|NCT01867554|"~     Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is~     identified only in 30 to 60% of cases.~      The purpose of this study is to indentify genes involved in ID with new genetics tools~     (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.~   "
90890|NCT01867541|"~     Refractive outcome after cataract surgery mainly depends on the prediction of the~     intraocular lens that is implanted in the eye during surgery.~      Aim of this study is to measure the position of the lens capsule during surgery and to use~     this measurements to improve post-operative refractive outcomes.~   "
90891|NCT01867528|"~     Small bowel obstruction is a common reason for surgical admission. Most common reason for~     small bowel obstruction is adhesions, which account up to 70-80 % of small bowel~     obstructions. Large proportion of adhesive small bowel obstructions may be treated~     nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for~     surgical intervention is open adhesiolysis. Recently, retrospective studies have provided~     encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no~     prospective randomized trials have been carried out and retrospective series carries a high~     risk for patient selection and bias. Although in general laparoscopy has been associated~     with shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for~     small bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7%~     of patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis.~     The investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the~     hospital stay, and reduce mortality compared to open approach.~   "
90892|NCT01867515|"~     The purpose of this program of research is to understand the perception of the dynamic~     spectral properties of speech by hearing-impaired listeners, with the long-term goal of~     improving speech understanding by these individuals in adverse listening conditions. The~     proposed research compares the performance of normally-hearing and hearing-impaired~     listeners on measures of speech understanding in the presence of different types of signal~     distortion and speech understanding of signals with enhanced spectral dynamics. A~     computational model based on the amount of potential information available in speech will be~     used to quantify differences in speech intelligibility due to hearing status and stimulus~     characteristics.~   "
90893|NCT01867502|"~     Exercise is considered a way to benefit the health of unhealthy and healthy individuals.~     This is confirmed by different scientific researches, in which people who participated~     improve their health. The present study will be conducted to test the hypothesis that~     vildagliptin associated with metformin may have more impact in improving glucose variability~     after a sub-maximal exercise test, as compared to glibenclamide. Our general aim will be to~     evaluate glucose variability after the submaximal exercise test under the treatment with~     vildagliptin or glibenclamide. The specific aims of this study are to evaluate the oxidative~     stress, endothelial function, metabolic and cardiovascular responses to exercise under the~     treatment with vildagliptin or glibenclamide. All these responses are important in patients~     with Diabetes Mellitus type II. Allied to the patient's routine treatment (metformin), they~     will receive orally a second drug, to take in 12 weeks. The patients will be raffled to take~     one of the two drugs that act on glycemia, that are called vildagliptin (50 mg of this drug~     twice a day) and glibenclamide (5 mg once a day during the first week and later you will~     increase to 5 mg twice a day). The metformin drug will continue be used.~      Patients who meet the eligible criteria for the study will first make the test of the~     maximum effort, to determination of peak oxygen consumption (VO2peak) and ventilatory~     thresholds. Forty eight hours after this test, patients will be allowed to do the pre-drugs~     protocol that will be given in three consecutive days as explained below.~        -  Day 1: Begin a 24-hour urinary collection, perform vascular doppler ultrasound to~          evaluate endothelial function and then the glucose sensor will be inserted~          subcutaneously (begin continuous glucose monitoring system - CGMS evaluation);~        -  Day 2: End the 24-hour urinary collection, submit to the submaximal test (blood~          collection at baseline, 15 and 30 min of the session, and 60 min after recovery). On~          the same day, the patients will begin 24h ambulatory blood pressure monitoring~          (24h-ABPM).~        -  Day 3: Removal of the glucose sensor; end of the 24h ABPM, randomization. This same~          protocol, except the randomization will be repeated at the end of the 12 week~          treatment.~   "
91143|NCT01864226|"~     This single-center, randomized, investigator/subject-blind, adaptive multiple~     ascending-dose, placebo-controlled study will evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be~     randomized to receive either RO5545965 or matching placebo daily for 12 days.~   "
90894|NCT01867489|"~     This qualitative study explores how patients deal with the side effects from chemotherapy at~     their home, what factors and ideas influence their symptom self-management and how~     professional caregivers contribute to the management of their symptoms at home. Data are~     collected through semi-structured interviews with adult patients treated with chemotherapy~     and analysed using a Grounded Theory approach.~   "
90895|NCT01867476|"~     The purpose of this study is to determine the feasibility and accuracy of an automated~     adherence monitoring system, and to compare the variance between urine and oral fluid~     riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen~     interval.~   "
90896|NCT01867463|"~     Background:~      - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine~     that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine~     called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in~     mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites~     from developing in the mosquito. As a result, the mosquito will not spread malaria to the~     next person it bites. However, the vaccine will not directly prevent people vaccinated from~     getting sick with malaria. Researchers want to test this vaccine in people who live in rural~     Mali. To do so, the study will compare the symptoms and the blood tests of the participants~     who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine.~      Objectives:~      - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~        -  Participants will be separated into two groups. One group will have~          Pfs25-EPA/Alhydrogel to test the study vaccine. The other group will have the regular~          Hepatitis B vaccine series, meningococcal vaccine.~        -  In the study vaccine group, participants will have either a lower dose or a higher~          dose. For the lower dose, they will have two vaccine shots over 1 year. For the higher~          dose, they will have four vaccine shots over about 14 months.~        -  In the other vaccine group, participants will have the Hepatitis B vaccine series,~          meningococcal vaccine according to the standard dose schedule.~        -  All participants will provide regular blood samples for testing during the study.~        -  Participants who develop malaria during the study will participate in evaluation of~          transmission and parasite development of malaria parasite from the person to mosquito~          via transmission assays. They will allow mosquitoes (that have no diseases) to bite~          them in a controlled clinic setting. This will let researchers see if the vaccine can~          stop the mosquitoes from carrying malaria to other people.~   "
90897|NCT01867450|"~     Background:~      - Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However,~     diesel exhaust fumes can have harmful effects on the body. Researchers are interested in~     studying how diesel exhaust exposure can affect lung health. To study these effects,~     researchers will look at employees of a diesel truck engine testing facility in China. Some~     workers at this facility are exposed to high levels of diesel exhaust. This study will~     compare tests and monitoring information from a group of highly exposed workers and a~     similar group of unexposed comparable controls.~      Objectives:~        -  To study the effects of diesel exhaust on lung health.~      Eligibility:~        -  Participants will be drawn from a diesel truck engine testing facility and other~          workplaces in China.~        -  Individuals at least 18 years of age who work in workshops with diesel fuel.~        -  Individuals at least 18 years of age who work in workshops that do not use diesel fuel.~      Design:~        -  Depending on what type of factory study subjects work in, participants will wear~          personal air pumps and small badges on their clothing on one or more days. This~          equipment will measure particles, chemicals, and other compounds in the air. This~          information plus other information collected in the study including workplace practices~          will be used to estimate exposure to diesel exhaust among study subjects.~        -  Participants will provide a number of study samples. These samples include blood,~          urine, and sputum. To collect other samples, participants will also have a mouth rinse,~          cheek cell scrapes, and nasal cell scrapes. They will also have a physical exam.~        -  Treatment will not be provided as part of this study. Participants will receive~          financial compensation for participation in the study.~   "
90898|NCT01867437|"~     Background:~      - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It~     has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it~     is not fully known whether RM-493 causes weight loss by just decreasing appetite or by~     increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and~     hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite~     by assessing feelings of hunger and fullness. They will study this drug in people who are~     obese but are otherwise in good health.~      Objectives:~      - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy~     individuals.~      Eligibility:~      - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40~     kg/m2) but are otherwise healthy.~      Design:~        -  The study consists of three phases. The first phase is the screening visit. The second~          phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week~          after the end of the second phase.~        -  Participants will be divided into two groups. One group will receive the study drug~          first, followed by a placebo. The other group will receive the placebo followed by the~          study drug. The study drug and placebo will be given under the skin for 3 days each by~          a small device (OmniPod) that normally is used to give insulin to people with diabetes.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also meet with a dietitian. The OmniPod device~          will be demonstrated before use.~        -  Participants will have the following procedures during their 8-day inpatient stay:~        -  Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles~          per hour) during an exercise test~        -  Wear physical activity monitors~        -  Body composition study to measure amounts of fat and muscle~        -  Calorie controlled study diet~        -  Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7)~        -  Metabolic rate studies using a cart or the metabolic chamber~        -  Daily blood samples~        -  Urine collection for 24 hours~        -  Questions about weight history and appetite~        -  About a week after the inpatient stay, participants will have a followup phone call to~          ask about any side effects from the study.~   "
90899|NCT01867424|"~     Background:~      - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to~     hormonal therapy. However, some cell characteristics of other prostate cancers cause it not~     to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast~     agent used to help identify damaged liver tissue, can help tell these types of prostate~     cancer apart. It may be able to identify if a man has a type of prostate cancer for which~     hormone therapy may not work as well.~      Objectives:~      - To see if gadoxetate can help identify different types of prostate cancers during imaging~     studies.~      Eligibility:~      - Men at least 18 years of age who have prostate cancer. Participants will be having surgery~     to either remove the prostate or take tumor tissue samples.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They~          will receive gadoxetate during the MRI scan.~        -  Participants who have surgery will have a sample of their tumor cells collected. Those~          who have a biopsy will provide cells from this biopsy for study.~        -  Treatment will not be provided as part of this study.~   "
90916|NCT01867203|"~     Patients needing lipid lowering therapy will be recruited before initiation of the~     treatment. For each patient, total and LDL cholesterol levels before start of therapy will~     be measured. One, three and six months after his/her first visit, when steady-state will be~     reached, for each included patient, the cholesterol levels will be re-assessed in order to~     evaluate the response to statin therapy calculated as the amplitude of cholesterol~     reduction. The aim is to assess the association between patient's genotype and the response~     to statin therapy.~   "
90900|NCT01867411|"~     Background:~      - Smoking is a difficult habit to quit, and some people find it more difficult to quit than~     others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine~     changes some patterns of brain activity, and smokers have differences in brain activity when~     compared to non-smokers. Some genes make it more likely that a person will become addicted~     to smoking. Researchers want to study how nicotine interacts with genes and brain activity.~     This may help develop better treatments to help people quit smoking.~      Objectives:~      - To develop a test of nicotine dependence, using brain activity and genetic analysis, which~     may be useful in predicting success in smoking cessation and in the development of new~     smoking cessation treatment targets.~      Eligibility:~        -  Main group: Current smokers between 18 and 55 years of age who are seeking treatment to~          quit.~        -  Comparison group: Current smokers between 18 and 55 years of age who are not seeking to~          quit.~        -  Comparison group: Healthy former smokers between 18 and 55 years of age.~        -  Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected.~        -  The three comparison groups will have one magnetic resonance imaging (MRI) scan~          session. They will have tests of thinking, concentration, and memory both inside the~          scanner, and while sitting in front of a computer.~        -  Current smokers who are trying to quit must be willing to undergo a course of nicotine~          treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants~          will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They~          will do thinking, concentration, and memory tasks inside and outside of the scanner.~        -  For smokers, the first scanning session will take place before they attempt to quit.~          This will be a baseline scan. The second scanning session will take place 48 hours~          after having their last real cigarette. After this scan, they will use electronic~          cigarettes to help quit their habit.~        -  After using e-cigarettes for two weeks, smokers will have a third scan session.. They~          will then gradually taper their use of the electronic cigarettes over the course of~          three weeks, at which point they will be nicotine abstinent.~        -  After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will~          be approximately 6 months after start of the study, and the final scan will take place~          at about 1 year from the study start.~        -  Smokers will continue to receive support on quitting smoking until the study ends at~          about 1 year.~   "
90901|NCT01867398|"~     Background:~      - Some children and teenagers have conditions known as conduct disorders. They often have~     long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders~     are often treated with antipsychotic medication. Researchers want to study two types of~     newer antipsychotics (aripiprizole and risperidone) for children and adolescents with~     conduct disorders. They will look at how these drugs affect brain activity. To do so, they~     will give brain activity tests using magnetic resonance imaging (MRI). The tests will~     compare the results from healthy volunteer children and teens to those of others with~     behavior problems.~      Objectives:~      - To see how atypical antipsychotics affect brain activity of children and teenagers with~     conduct disorders.~      Eligibility:~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are taking aripiprizole.~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are taking risperidone.~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are not taking an atypical antipsychotic.~        -  Healthy volunteers between 10 and 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~          Parents/guardians will be asked questions about their child s feelings, experiences,~          and behavior. Participants will also answer questions about their feelings and moods.~        -  This study will involve two visits. Each visit will involve MRI scanning.~        -  At the first visit, participants will have memory and thinking tests. The tests will~          involve making decisions or playing games. Some of these tests will use MRI scanning to~          look at brain activity.~        -  The second visit will be 3 to 5 months after the first visit. The tests from the first~          visit will be repeated.~   "
90902|NCT01867385|"~     Background:~      - Fatigue is a common and often disabling symptom in people with chronic liver disease. Its~     causes are not well understood. Sleep disturbance may play a role in people with cirrhosis,~     but these factors have not been studied in people with other stages of liver disease. This~     study will look at the body's circadian rhythms (internal clock) to see if problems with~     these rhythms can contribute to fatigue. It will look at the causes and mechanisms of~     fatigue in people with chronic liver disease by comparing people with and without fatigue.~      Objectives:~      - To study reasons for fatigue in people with chronic liver disease.~      Eligibility:~        -  <TAB>Individuals at least 18 years of age who have chronic liver disease.~        -  <TAB>Participants with or without fatigue may enroll.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have~          a 2-day inpatient stay for the study.~        -  For the 7 days before the inpatient stay, participants will keep a sleep diary. They~          will record any caffeine or alcohol consumption, medicines, exercise, and sleep or~          naps. They will also wear an actigraph to measure their activity levels.~        -  During the inpatient stay, participants will answer questions about fatigue and sleep~          habits. They will have regular blood tests for 24 hours. Their body temperature will~          also be monitored. During the night, they will have a sleep study to look at how well~          or poorly they sleep.~        -  Treatment will not be provided as part of this study.~   "
90903|NCT01867372|"~     Background:~      - Participants in the Baltimore Longitudinal Study of Aging are being studied to examine~     changes in brain structure and function over time, and to determine if these changes can~     predict the likelihood that an individual will develop thinking and memory impairments such~     as Alzheimer s disease later in life. Imaging studies and neuropsychological testing have~     been conducted on current participants, and new participants are being recruited to the~     study. To develop better treatments and therapies for aging-related memory loss and other~     disorders, researchers are interested in determining whether early prediction of thinking~     and memory impairments are accurate and in evaluating factors that affect these predictions.~      Objectives:~      - To use imaging studies and tests of thinking and memory to determine early markers of~     Alzheimer s disease and other cognitive impairments.~      Eligibility:~      - Current participants and new recruits to the Baltimore Longitudinal Study of Aging.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests.~        -  Participants will have testing visits as directed by the study researchers. All~          participants will have tests as part of their an initial enrollment in the study, and~          may be asked to return yearly, 2 years later, or 4 years later for repeated tests.~        -  At each visit, participants will have brain imaging scans (including magnetic resonance~          imaging and/or magnetic resonance spectroscopy to measure brain structure and function,~          and positron emission tomography to study blood flow in the brain) to evaluate brain~          structure and function. Participants will also take tests of memory and problem-solving~          skills.~        -  Treatment will not be provided as part of this protocol.~   "
90904|NCT01867359|"~     Background:~      - Researchers are interested in learning more about dementia and its causes. They want to~     look at the genetic basis of dementia. Identifying genetic aspects of dementia may help~     provide better tests and treatments for it. It may also show rare gene variants that can~     cause or alter a person's risks for developing dementia. This study will look at people who~     have dementia, their family members, and healthy volunteers.~      Objectives:~      - To study genetic influences on dementia.~      Eligibility:~        -  Individuals who have been diagnosed with dementia.~        -  Family members of individuals who have been diagnosed with dementia.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be interviewed and answer questions about their medical history. They~          will also provide general information on the relatives' medical histories.~        -  Participants will provide a blood sample for genetic testing.~        -  Participants will remain on the study for up to 10 years. They will have regular visits~          to monitor their brain health and function.~        -  Treatment will not be provided as part of this study.~   "
90917|NCT01867190|"~     This study will assess the safety and efficacy of intra-arterial infusion and intramuscular~     injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) versus~     placebo in patients with critical limb ischemia who have exhausted all medical and surgical~     therapeutic options. The safety and tolerability will be evaluated by regular monitoring of~     the general physical condition, vital signs, and the occurrence of AE and SAE, respectively.~     Furthermore, the standard biochemical and blood variables (red and white blood cell counts,~     Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin,~     total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine,~     immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90~     days after the treatment.~   "
90905|NCT01867346|"~     Background:~      - The Baltimore Longitudinal Study of Aging (BLSA) is a long-term study of human aging. To~     see how the brain changes with age, researchers will study BLSA participants who are at~     least 60 years old. In particular, researchers are looking for early markers of possible~     Alzheimer's disease and other conditions that cause memory loss. To do so, they will give~     tests of memory and brain function, and stay in close contact with participants.~      Objectives:~      - To study cognitive changes that occur in normal aging and in people who develop memory~     problems.~      Eligibility:~      - Individuals at least 60 years of age who are participating in the BLSA.~      Design:~        -  There are three parts to this study. These study procedures will be done under the~          usual BLSA guidelines.~        -  Participants will take paper and pencil tests. The tests measure skills such as~          language, attention, memory, and problem solving. They will also ask questions about~          emotions and feelings.~        -  Participants will give the name and phone number of a person who knows them well and~          sees them often. Researchers will ask this person to fill out questionnaires on the~          effects of aging on the participant. These questions will monitor the participant's~          memory and ability to function independently.~        -  Participants will have regular phone calls between study visits. These calls will help~          to keep their information up to date.~        -  Participants will continue on this study for as long as they are able to participate.~   "
90906|NCT01867333|"~     Background:~      - Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is~     given after chemotherapy and surgery to help the body destroy the cancer cells. A new~     possible way of treating prostate cancer is using a vaccine that may help stimulate the~     immune system. It will help white blood cells recognize and kill the cancer cells in and~     around the prostate. Researchers want to see whether this vaccine, given with enzalutamide,~     is more effective at treating advanced prostate cancer than enzalutamide alone.~      Objectives:~      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy~     for advanced prostate cancer.~      Eligibility:~      - Men at least 18 years of age who have advanced castration-resistant prostate cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be used to monitor the cancer before~          treatment.~        -  Participants will be separated into two groups. One group will have enzalutamide and~          the study vaccine. The other group will have enzalutamide alone.~        -  All participants will take enzalutamide once a day. They will take the drug during~          4-week cycles of treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Participants~          will continue to take the study drug for as long as the cancer does not grow and the~          side effects are not severe.~        -  The vaccine group of participants will also have the new study vaccine. They will have~          a single injection on the first day of the first study cycle. There will be regular~          booster injections afterward. There will be one on day 15 of the first cycle, the first~          day of the second cycle. The vaccine will then be given every 4 weeks for the next four~          cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue~          to have the study vaccine for as long as the cancer does not grow and the side effects~          are not severe.~   "
90907|NCT01867320|"~     Background:~      - Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis~     (HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has~     been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs.~     Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus~     (HIV), can be used to treat HAM/TSP. They will see if the drug can reduce the amount of~     virus in the blood of people with HAM/TSP.~      Objectives:~      - To see if raltegravir can reduce the viral load of people with HAM/TSP.~      Eligibility:~      - Individuals at least 18 years of age who have HAM/TSP.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies will be performed. A lumbar puncture will also be~          taken.~        -  Participants will take the study drug twice a day for 6 months. They will note each~          dose in a study diary, as well as any side effects.~        -  At the 6-month visit, participants will stop taking the study drug. They will have a~          physical exam and blood samples, as well as other tests.~        -  Participants will have two further exams 9 months and 15 months after starting the~          study drug. They will have a physical exam and blood samples, as well as other tests.~   "
90908|NCT01867307|"~     Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on~     kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus~     and healthy controls~   "
90909|NCT01867294|"~     This randomized phase II trial studies how well giving spironolactone works in preventing~     rash in patients with advanced cancer receiving panitumumab and cetuximab. Spironolactone~     may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.~   "
90910|NCT01867281|"~     The purpose of this study is to determine the effect of aspirin desensitization on symptoms~     and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).~   "
90911|NCT01867268|"~     -  Purpose of study : to determine the preventive effect of acetazolamide administration,~          prone positioning, and the combination of both following the neurosurgical~          interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection~          and wound dehiscence.~        -  Sample size: 144~        -  intervention groups:~             -  Group A: Acetazolamide administration for 10 days~             -  Group B: prone positioning for 10 days~             -  Group C: Acetazolamide administration and prone positioning for 10 days~             -  Group D: no intervention~        -  Period of study: Autumn 2012 to the end of winter of 2015~   "
90912|NCT01867255|"~     The purpose of the study is to determine whether a significant and predictable change in~     bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.~   "
90913|NCT01867242|"~     This is a multi-center trial involving the University of Minnesota, Ohio State University~     Comprehensive Cancer Center, and Roswell Park Cancer. Cigarette smokers who are eligible~     will enter a Camel Snus sampling phase. Smokers interested in continuing with the study~     after the sampling phase will undergo a 2 week baseline assessment phase and will then be~     randomized to one of the five experimental conditions for 8 weeks. Tobacco use patterns,~     subjective responses to product, and nicotine and toxicant exposure will be assessed.~   "
90914|NCT01867229|"~     Relation between chemotherapy and amennorhea~   "
90915|NCT01867216|"~     The main purpose of this study is to determine the safety of LY2922470, taken as oral~     capsules, once or twice daily for approximately 28 days, in participants with diabetes. It~     also aims to determine how long the drug stays in the body and how it affects blood sugar~     levels. A screening appointment is required within 28 days before the start of the study and~     a follow up appointment is required approximately 14 days after the last study dose is~     taken.~   "
90943|NCT01865812|"~     The purpose of this study is to determine if obeticholic acid (OCA) has an effect on~     cholesterol levels in the blood in patients with PBC.~   "
90918|NCT01867177|"~     The purpose of this study is to conduct a cross-site evaluation of the Kaiser Permanente's~     Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program,~     designed to support community-based interventions to reduce the number of new HIV cases and~     to increase HIV care acquisition and maintenance in minority communities disproportionately~     affected by the HIV epidemic. This effort builds on the President's National Strategy for~     HIV Prevention and recent research documenting the importance and efficacy of test and~     treat and treatment as prevention approaches. Hence, goals of this important and novel~     work will focus on the following objectives:~        1. identification of HIV infection among recently infected adolescents and adults~        2. improved access to HIV care, particularly among newly diagnosed adolescents and adults~      To achieve these objectives, the following outcomes are expected from grantee programs:~        1. increased HIV testing among populations at risk for HIV~        2. improved health care utilization among HIV infected adults and adolescents~      This initiative has been undertaken by Kaiser to affect HIV at a population level via~     community approaches to prevention, intervention and care in minority communities most~     affected by HIV (e.g. gay, African American, and Latino communities). The University of~     California, San Diego has developed and will oversee a cross-site evaluation of Kaiser~     grantee programs funded under this initiative. Each site will have a treatment and~     comparison group, and will conduct follow up surveys with their participants three and six~     months after their interventions.~   "
90919|NCT01867164|"~     The purpose of this comparative study is to evaluate the efficacy of an ovule with triple~     active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple~     active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused~     by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis~     (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella~     vaginalis and other anaerobic organisms and a decrease in lactobacilli).~   "
90920|NCT01867151|"~     Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and~     multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or~     gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected~     by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and~     especially tongue burning sensation, deeply decreasing the quality of life of patients~   "
90921|NCT01867138|"~     The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to~     vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial~     sepsis probably caused by Coagulase-negative staphylococcus.~      The investigators hypothesized that newborn infants with the presumptive diagnosis of~     nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome~     not inferior to that of those treated with vancomycin.~   "
90922|NCT01867125|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease~     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and~     at least one second controller medication. Participants will be randomized in 1:1:1 ratio to~     receive double-blind treatment with either lebrikizumab (high or low) or placebo,~     administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their~     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment~     extension. During double-blind active treatment extension period, all participants will~     receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study~     treatment is 104 weeks. After study treatment, all participants will complete a 20-week~     safety follow-up.~   "
90923|NCT01867112|"~     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of~     this study is to explore the connection between level of physical activity and health~     parameters, quality of life, and frailty.~   "
90924|NCT01867099|"~     Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when~     patients do not respond favorably to medical therapy. Successful procedures are accomplished~     in the majority of patients, but the outcome after many years of follow-up after ablation is~     unknown.~   "
90925|NCT01867086|"~     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with~     carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells~     obtained at the time of primary surgical debulking. Patients meeting eligibility criteria~     will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC~     5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x~     10e7 cells/intradermal injection, once every 3 weeks.~   "
90926|NCT01867073|"~     OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical~     Company, Ltd, and is currently undergoing clinical investigation at the National University~     Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and~     pharmacogenetic biomarker study is initiated and funded by the investigators, and will be~     conducted in conjunction with the extension phase I protocol of OPB-51602 in patients with~     advanced solid tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and~     pharmacogenetic samples will be collected, stored and analysed at the local laboratory of~     the study site (Cancer Science Institute, National University Health System, Singapore, Dr~     Boon-Cher Goh).~   "
90927|NCT01867060|"~     This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm~     Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial~     Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3~     months, will detect significantly more cases of PAF than the ACER, used continuously for one~     week.~      A case-control sub-study will identify individuals with confirmed PAF, and matched~     individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.~      A further case-control study will assess markers of left atrial function in patients with~     PAF and their matched controls.~      Another case-control sub-study will determine the significance of frequent Atrial Premature~     Beats (APBs) in the development of AF over a one year period.~   "
90928|NCT01867047|"~     The purpose of this study is to determine the effects of Angiotension Converting Enzyme~     Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients~     undergoing elective total hip or knee arthroplasty.~   "
90929|NCT01867034|"~     It is hypothesized that patients with low pre-PCI serum levels of sRAGE should receive DES~     implantation and/ or procedures taken to increase serum levels of sRAGE and/ or decrease the~     serum levels of AGE.~      The purpose of this pilot study is to afford invasive cardiologists with additional~     evidenced based information to guide their decision as to which patients should receive a~     BMS or DES for coronary implantation.~      The objectives of the study are to determine whether or not:~        1. Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop~          restenosis~        2. Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will~          have reduced risk of the development of restenosis~        3. Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will~          have an increased risk of the development of restenosis~   "
90930|NCT01867021|"~     Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition~     (HI) Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV)~     over the corresponding GMTs of the comparator vaccine for all three strains, in healthy~     adults aged 50 years and above.~      Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in~     antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in~     the comparator group for all three strains, in healthy adults aged 50 years and above.~   "
90931|NCT01865968|"~     A phase IV, randomization, single center, controlled clinical trial to compare the safety,~     immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with~     one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young~     adults, and to evaluate the immunogenicity of a booster dose.~   "
90932|NCT01865955|"~     Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly~     performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to~     facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar~     punctures, performance of spinal anesthesia in non-obstetric patients and accurate~     identification of the interspace at which the puncture is being performed. This is~     especially important during spinal anesthesia, where puncture below the ending of the spinal~     cord is recommended for safety.~      The purpose of this study is to compare the performance of spinal anesthesia between the~     pre-procedural ultrasound assessment of the spine and the traditional palpatory technique,~     in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to~     describe sonoanatomic features of the spine that could predict the ease of insertion of~     spinal anesthesia in that patient population.~      We hypothesize that in term pregnant women undergoing elective cesarean delivery,~     pre-procedural ultrasound assessment of the spine will improve the success rate of spinal~     anesthesia at first attempt, compared to the traditional palpatory technique.~   "
90933|NCT01865942|"~     The investigators wish to evaluate the effect of minimal access spinal surgery compared to~     traditional open surgery spinal surgery in patients with metastatic spinal cord compression.~      Minimal access surgery has been shown to bee less damaging for the tissue compared to~     traditional open surgery and also cause fewer wound complications, the investigators expect~     the above could have impact in a vulnerable patient group like patients with metastatic~     spinal cord compression.~   "
90934|NCT01865929|"~     A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods;~     robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy;~     outcome and cost analyses.~   "
90935|NCT01865916|"~     This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority~     trial. The purpose of our study is to determine if using a 2-litre mixture in combination~     with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre~     PegLyte based preparations with an added laxative agent are commonly used for colonoscopies~     in outpatient settings. If the investigators discover that a 2-litre mixture with either the~     tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be~     able to experience fewer side effects and be less troubled by the preparation while still~     allowing a good view of the colon.~   "
90936|NCT01865903|"~     Weight loss and loss of lean body mass are common and associated with adverse outcomes such~     as loss of strength, reduced immune- and pulmonary function and increased disability in~     advanced cancer. Progressive weight loss interferes with cancer therapy and is responsible~     for reduced quality of life (QoL) as well as shorter survival irrespective of tumour mass or~     presence of metastases. Weight loss in advanced cancer is regarded as a major clinical~     challenge because of its serious consequences, its varying aetiology and the contribution of~     multiple pathophysiological mechanisms that are poorly disentangled.~   "
90937|NCT01865890|"~     The investigators are trying to find out if Clopidogrel (Plavix) is as effective in~     hemodialysis patients as in patients not hemodialysed.~   "
90938|NCT01865877|"~     The objective of the study is to assess the effect of motor, non-motor and genetic factors~     on the progression of Parkinson's disease as well as its impact on complications rates.~      A large sample of Mexican subjects with Parkinson's disease attending several referral~     centers will be included.~      Data collected will include disease severity and motor scales, non-motor scales as well as~     genotyping for monogenic forms of the disease.~      Assessments will be performed every 6 months for two years.~   "
90939|NCT01865864|"~     to test whether using CPAP can restore the normal pattern of drop of blood pressure during~     sleep.~   "
90940|NCT01865851|"~     Currently used face mask has certain disadvantages; such as, not providing a complete seal~     in certain patients, causing hand fatigue after holding the mask in place for more than a~     few minutes, causing claustrophobia in an occasional patient, the need to hold the mask from~     head of the bed, and possible worsening of the trauma in patients with facial injuries, and~     the need to use different size masks in different patients. The NuMask overcomes all of~     these disadvantages and does benefit the patients.~   "
90941|NCT01865838|"~     The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent~     in minimising internal adhesion formation in the neck after thyroid surgery and therefore~     reduce swallowing discomfort experienced by patients after surgery.~   "
90942|NCT01865825|"~     The investigators would like to determine if there are patients with PPI responsive~     Eosinophilic Esophagitis Infiltration that have significant loss of esophageal~     distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic~     Esophagitis.~      If this group of patients exists, the investigators would like to determine if they have the~     typical endoscopic features of EoE rather than those of GERD.~   "
90944|NCT01865799|"~     This is a prospective, 3-year observational study to describe drug utilization in uninfected~     individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)~     (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.~      An electronic source of pharmacy/medical encounter information will be used to assess the~     demographics and other characteristics of the subjects prescribed FTC/TDF or its components~     in a prospective fashion. The data provider will supply all the de-identified information~     regarding each visit/interaction that the subject has had with the health system and all the~     diagnoses and medications that the UI has had prospectively and retrospectively for the~     length of time captured by the source selected.~      200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same~     source.~   "
90945|NCT01866995|"~     The purpose of this study is to investigate the efficacy of Phytotherapy Raylis (Ginseng~     Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Root Powder 50 mg, Astragalus~     Membranaceus Root Powder 50 mg, Epimedium Alpinum Herbal Extract 100 mg) In Congestive~     Processes Of The Pelvic Organs (Prostatostasis) In Congestive Processes Of The Pelvic Organs~     (Prostatostasis)~   "
90946|NCT01866982|"~     Premature babies can be very sick and have bleeding in the brain. Giving babies more blood~     before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has~     been shown to reduce the risk of bleeding in the brain. This may be related to improving~     perfusion to the brain. However, some studies suggest that delayed cord clamping may not~     increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the~     umbilical cord may give more blood in babies delivered by Cesarean Section may improve~     perfusion and reduce bleeding in the brain.~   "
90947|NCT01866969|"~     This clinical trial studies quality of life in caregivers of hospitalized older patients~     with cancer.~   "
90948|NCT01866956|"~     The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use~     diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes.~     The self-administered version of the KSADS-COMP can also be used cost-effectively in schools~     and juvenile justice settings where there is a growing interest in early identification and~     referral of youth in need of mental health services. The KSADS-Bridge assessment tool with~     its RDoC neurocognitive tasks, when completed with the self- or clinician administered~     KSADS-COMP, will help to create cross-talk between the DSM and RDoC diagnostic perspectives,~     and begin to generate a database on the relationship between RDoC constructs and treatment~     outcomes across a range of diagnostic categories.~   "
90949|NCT01866943|"~     Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss,~     requiring blood transfusions in some patients. The major cause of this blood loss is due to~     surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies~     and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent~     that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous~     form has been extensively studied and shown to be efficacious in cardiothoracic, spine~     surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical~     tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well.~     Recently, results from a prospective randomized study on the topical use of tranexamic acid~     in total knee arthroplasty found it to be effective for reducing postoperative blood loss.~     Taking all of the above into consideration we have proposed a study to evaluate effects of~     topical application of tranexamic acid on postoperative blood loss and blood transfusion on~     patients undergoing total hip arthroplasty. The aim of this study is to evaluate the~     efficacy of the topical application of tranexamic acid on blood loss in patients undergoing~     a primary unilateral total hip arthroplasty.~   "
90950|NCT01866930|"~     To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following~     treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with~     HIV-1~   "
90951|NCT01866917|"~     Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for~     obese women undergoing laparoscopic or robotic gynecologic procedures.~   "
90952|NCT01866904|"~     THis study is intended to provide contemporary data on the burden of disease in patients 1~     to 3 years post-MI, including a description of patient characteristics, current treatment~     patterns, rate of major CV events, and healthcare resource utilization in a 'real world'~     patient population at high atherothrombotic risk.~   "
90953|NCT01866891|"~     Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease~     (PAD). This could lead wounds, infections then amputations or deaths by impairment of the~     peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only~     slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is~     decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many~     studies have shown several various favorable effects of the perdialytic physical activity.~     There is currently no data about effects of the perdialytic activity on the lower extremity~     perfusion. The aim of this clinical study is to show the impact of three months perdialytic~     cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be~     the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure~     (tcPO2) on about twenty patients.~   "
90961|NCT01866787|"~     The purpose of this observational study is to evaluate the baroreceptor function in relation~     to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.~      The main hypothesis is that baroreceptor function is attenuated after surgery and related to~     surgical inflammation.~   "
90970|NCT01866670|"~     Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image~     guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three~     days of intervention in the same week. The first day the participants will be evaluated if~     she meets the needs of the research and will answer questions about their indentification~     and spirituality.~      Type of study: intervention Study design: randomized controlled trial Masking: blind study.~     Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences)~     version 15, organized in sealed envelopes by another qualified professional.~      The research ends in 2014 jun.~   "
91144|NCT01864213|"~     Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It~     is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain~     of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not~     been studied.~   "
90954|NCT01866878|"~     Sensory disorders in patients with multiple sclerosis are among the most common symptoms~     encountered.~      A functional impairment based on sensory disorders of the hand. The hand is a sensory organ~     that transmits the cerebral cortex protopathic sensitive information, proprioceptive or~     epicritiques. The view-hand association plays an important role in the understanding of the~     environment. Its exploratory use remains an essential and voluntary basis. The process of~     recognition of the object passes through manipulation, but operates instantaneously. The~     brain is able to do a quick summary of the information it receives to determine the nature~     of the manipulated object. The exploration takes a posteriori, the brain can then determine~     the details component object (texture, shape, composition, temperature and weight).~      Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous~     electrical nerve stimulation (TENS) are not fully understood. Several theories underlying~     its use as a neuromodulator of pain. The gate control theory has led to the development of~     TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent~     fibers increases the control exerted on spinal level, thereby inhibiting the action of~     afferent fibers of small caliber related to nociception. This stimulation strengthens the~     blocking of gate at the corresponding cell bodies of spinothalamic tract and reduces the~     transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental~     presynaptic inhibition depends on the area and stimulated.~      The objective of this study is to improve the quality of life through improved sensitivity~     disorders of the hand in patients with MS, thanks to reeducation of the hand.~   "
90955|NCT01866865|"~     Background:~      - Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or~     ovarian cancer. They are also at increased risk of other developing other cancers. Male~     carriers are at increased risk for breast, prostate and other cancers. Testing for this~     mutation and living with this increased risk can be a source of stress for both people with~     the mutation and their partners. Researchers want to look at how well people adapt to living~     with this type of cancer risk over time.~      Objectives:~      - To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of~     long-term cancer risk.~      Eligibility:~      - Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female~     partners.~      Design:~        -  This study involves a one-time self-administered questionnaire. Participants will be~          recruited from local and national hereditary cancer support groups and cancer centers.~        -  There are two versions of the survey. One is for the woman with the BRCA1/2 gene~          mutation. The other is for her partner.~        -  The survey will ask about risk perception, cancer worry, risk-related stress, and~          coping and adaptation methods.~        -  Treatment will not be provided as part of this study.~   "
90956|NCT01866852|"~     Background:~      - An earlier study on child development focused on the relationship between children and~     their caregivers (usually mothers). It looked at how this relationship influenced children's~     social and mental development. It also studied how these children related with family~     members and friends. Researchers are now interested in expanding the study with the same~     group of children. They want to look at these children, who are now young adults, and focus~     on their current romantic relationships. This new study will look at how child development~     affects the formation of stable, mature romantic relationships in young adulthood. Original~     child study participants and their significant others will be included in the new study.~     Only participants who are living together with a partner will be studied.~      Objectives:~      - To look at romantic partnerships in a childhood study s original participants and their~     significant others.~      Eligibility:~        -  Participants of the 88-CH-32 study who are at least 18 years of age.~        -  Significant others of the study participants who are at least 18 years of age.~        -  Original participants and significant others must be cohabiting (living together).~      Design:~        -  No screening tests will be required for this study. No study visits will be needed.~          Samples will not be collected.~        -  Original study participants will fill out four online questionnaires. They will be on a~          National Institute of Child Health and Human Development (NICHHD) website. They will~          ask personal questions about relationships with the current romantic partner and other~          important people. The questions will take about 25 minutes to answer.~        -  Significant others will fill out 13 online questionnaires. They will be on a NICHHD~          website. They will ask personal questions about the romantic partner and other~          important people. The questions will take about 1.5 hours to answer.~        -  All participants will receive a small amount of money for completing the study.~   "
90957|NCT01866839|"~     Background:~      - Researchers are working to make stem cell transplant procedures safer and more effective.~     One complication of transplants is graft-versus-host disease (GVHD). This complication~     happens when certain white blood cells from the donor attack the recipient's own body.~     Researchers want to test a blood separator machine that may help remove more of the donor's~     white blood cells before transplant. They will study donors and recipients during stem cell~     transplant to see how well this process can prevent GVHD and other complications.~      Objectives:~      - To see if a new blood separator machine can improve outcomes of stem cell transplants.~      Eligibility:~        -  Individuals between 10 and 75 years of age who are having a stem cell transplant for~          leukemia or other blood-related cancers.~        -  Donors for the stem cell transplant.~      Design:~        -  Recipients and donors will be screened with a physical exam and medical history.~        -  Donors will have two blood collection procedures. The first will collect only white~          blood cells, and return the rest of the blood. After the first collection, participants~          will have filgrastim injections to help their stem cells enter their blood. Then, they~          will have a second blood collection for the stem cells.~        -  Recipients will have radiation and chemotherapy to prepare for the stem cell~          transplant. They will then have the stem cell transplant with the donor cells that have~          been treated with the blood separator machine.~        -  Recipients will be monitored closely after the procedure. They may receive some of~          their donor's white blood cells if needed to fight serious infections.~        -  Recipients will have the regular standard of care after their transplant. Blood samples~          will be taken and any side effects will be monitored and treated.~   "
90958|NCT01866826|"~     Background:~        -  Human immunodeficiency virus (HIV) treatment can control the amount of virus in the~          blood, but it does not provide a cure. The reasons why HIV treatment does not cure the~          infection are not well understood. HIV persists in blood cells for years, even if~          people receive treatment for it. In addition, HIV infection leads to an activated~          immune system, which can cause other problems.~        -  One theory for why HIV infection causes immune activation involves the intestinal~          tract. HIV infects immune cells the intestine soon after infection and damages their~          immune barrier. This damage lets bacteria cross into the bloodstream, leading to~          ongoing inflammation. Even when a person with HIV feels well, this chronic inflammation~          may affect the immune system. Researchers want to see if the antibiotic Rifaximin can~          reduce this inflammation. Rifaximin is designed to stay inside the digestive system, so~          it affects only bacteria in the intestines.~      Objectives:~      - To see if Rifaximin can reduce bacteria-related inflammation in people with HIV.~      Eligibility:~      - Individuals at least 18 years of age who have HIV infection and are taking medications to~     treat it.~      Design:~        -  Participants will be screened with a physical exam, blood test, and medical history.~        -  Participants will take either Rifaximin or a placebo for 4 weeks. They will have no~          medication for 4 to 6 weeks, and then take the other drug for 4 more weeks.~        -  During the study, participants will have frequent blood and urine tests. They will also~          provide stool samples. Liver and kidney function tests will be performed. HIV viral~          load (the amount of virus in the blood) will also be studied.~        -  Participants will have a final follow-up visit after an additional 4 weeks.~        -  Two additional tests are optional for study participants:~        -  Two blood draws: one on the third day after starting Rifaximin, and one on the third~          day after starting the placebo.~        -  Up to three colonoscopies of the lower intestine and biopsies of the intestine. These~          studies will collect samples of the intestinal tract to look at the effects of~          Rifaximin in the study.~   "
90959|NCT01866813|"~     The aim of the proposed study is to investigate whether women treated for breast cancer who~     experience cognitive difficulties will profit from the Internet-based program Scientific~     Brain Training Pro with respect to: 1) attention, working memory, learning and recall, and~     executive function as assessed by standardized neuropsychological tests and 2,)~     self-reported cognitive difficulties in daily life as measured by questionnaires.~   "
90960|NCT01866800|"~     Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast~     induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).~   "
91174|NCT01863823|"~     1. Gastric eradication has no effective on oral H. pylori infection.~        2. Treatment of oral infection increase success rate of eradication on stomach infection.~   "
90962|NCT01866774|"~     Triaging new pediatric gastroenterology consultations is challenging as both inflammatory~     and non-inflammatory gastrointestinal (GI) diseases can present with non-specific chronic~     abdominal pain and/or diarrhea. Examples of inflammatory GI diseases include Crohn's~     disease, ulcerative colitis and celiac disease and non-inflammatory GI diseases lactose~     intolerance, irritable bowel syndrome and non-ulcer dyspepsia. Inflammatory GI diseases~     require different investigations and treatment than non-inflammatory GI diseases and~     ideally, would be identified early. Higher priority triage of these patients would allow~     timely organization of further investigations including pertinent laboratory testing,~     radiologic studies and gastrointestinal endoscopies. These more invasive procedures are not~     needed in most patients presenting with non-specific gastrointestinal symptoms. Therefore,~     the investigators do not routinely ask for screening laboratory testing or other studies in~     children referred to our clinic.~      Non-invasive screening tests for GI disorders may aid in appropriately triaging new~     consultations to pediatric gastroenterology. Calprotectin is a protein found in inflammatory~     cells called neutrophils. The concentration of calprotectin in stool reflects the presence~     of an inflammatory process occurring in the GI tract. Thus, testing for calprotectin has~     been proposed as a potentially useful test for detecting some inflammatory GI diseases, most~     notably Crohn's disease and ulcerative colitis. Alternatively, a simple gastrointestinal~     questionnaire of red flag symptoms and family history of GI disorders may also be of~     benefit. The investigators hypothesize that the use of fecal calprotectin and a screening GI~     questionnaire will aid in identifying children at higher risk of an inflammatory GI~     disorder. Subsequently, higher priority triaging of these patients will decrease the time to~     diagnosis of inflammatory GI disease.~      This will be a single centre, stratified, randomized clinical trial conducted in Kingston,~     Ontario, Canada. Patients referred to the pediatric gastroenterology service without a known~     diagnosis for non-specific chronic abdominal pain and/or diarrhea will be asked to~     participate in the study. All patients who meet the inclusion criteria will be consented by~     telephone with a standard form. Consenting patients will be mailed the GI questionnaire and~     the fecal calprotectin test kit. The fecal calprotectin test kid includes instructions, a~     stool collection kit and return postage. All patients will be given the next available~     appointment with a pediatric gastroenterologist. Patients will then be randomized to receive~     either usual care (50%, 40 patients) or to have a screening fecal calprotectin (FC)~     measurement (50%, 40 patients). Patients in the FC group will have FC measured by the~     Quantum Blue® Rapid Calprotectin Assay. If the calprotectin level is high (above 50 μg/g),~     the patient will be contacted again by telephone and given a new appointment time (within 14~     working days). This study may have a positive impact by demonstrating a novel method for~     decreasing the time to diagnosis of inflammatory GI disease.~   "
90963|NCT01866761|"~     Objective: We aimed at analyzing the relationship between periodontal disease and~     atherosclerosis in medical treatment and periodontal treatment under medical and dental care~     across borders in a local cooperation system of Japanese medical services.~      Materials and methods:~        -  A prospective multi-center case cohort study was conducted on 37 ambulatory medical~          patients (with lifestyle-related diseases under consultation in either of the medical~          clinics registered as collaborative investigation facilities) and 79 periodontal~          patients (who were seen by the dental clinics registered as collaborative investigation~          facilities).~        -  Medical treatment and clinical periodontal treatment were provided on the subjects~          under medical and dental care across borders by each internal medicine and dental~          clinics.~        -  Systemic examination of lifestyle-related disease and periodontal examination were~          performed before and after periodontal treatment, and the relationships between~          periodontal and atherosclerosis-related clinical markers were analyzed before and after~          periodontal treatment.~   "
90964|NCT01866748|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability and pharmacokinetics (the effect of the investigated drug on the body) of~     single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral~     formulation in healthy male subjects.~   "
90965|NCT01866735|"~     This study will demonstrate that Standardized Rehabilitation Therapy for burn patients with~     ARF reduces hospital stay through immediate improvement in functional capacity and~     functional performance. Our team comprises Burn Surgeons, Intensivists with expertise in~     Critical Care Trial design, Exercise Physiologists and Outpatient Functional Outcome~     Assessment Experts. The design was conceived through the US-Critical Illness and Injury~     Trials Group which allowed these investigators to bring varied expertise to the problems~     faced by critically ill Burn patients.~      Hypotheses:1) Standardized Rehabilitation Therapy (SRT) will shorten hospital stay in burn~     patients with ARF. 2) SRT will prevent loss in muscle size and loss of architecture during~     critical illness of severe burns. 3) SRT will improve objective functional measures and~     quality of life at 3, 6, 12, 24, and 36 months post-enrollment.~   "
90966|NCT01866722|"~     In our communications with the public, the investigators will call this the Not Quite Ready~     to Quit Smoking Study.~      One new method to increase quit attempts is to have smokers reduce their cigs/day. The~     investigators and others have shown that reduction aided by nicotine medications can~     increase quit attempts and later abstinence among smokers not ready to quit. Because half of~     smokers are reluctant to use nicotine medications for a non-cessation reason, the~     investigators now propose to test whether reduction not aided by nicotine medications can be~     effective. Another new method to increase quit attempts is motivational counseling. The~     investigators previously found implementation of the brief United States Public Health~     Service (USPHS) Guidelines 5 Rs motivational intervention via three 15 min phone calls can~     provide a large increase in quitting (OR = 6.3); however, the investigators need to~     replicate that result. A vendor will proactively email adult, daily smokers listed in a~     consumer panel to recruit 560 smokers who do not plan to quit in the next month and~     randomize them to a) reduction counseling without the aid of nicotine medications , b) brief~     counseling guided by the USPHS 5 R's, or c) usual care. The first two conditions will be~     delivered via brief counseling calls at study onset and then 2 and 4 weeks later (total = 35~     min). The usual care condition will consist of a brief (< 5 min) phone intervention followed~     by a quit guide. Our major hypothesis is that the incidence of quit attempts over the 6~     months of the study will be greater in both the reduction and the motivational conditions~     than in the usual care condition. A secondary hypothesis is that the increase in quit~     attempts will lead to increased abstinence. Another secondary hypothesis is that beneficial~     effects of both treatments will be mediated by increases in self-efficacy and intentions to~     quit. A final hypothesis is that decreases in cigs/day and nicotine dependence will mediate~     the efficacy of the reduction treatment but not the motivational treatment and, conversely,~     that a shift in decisional balance will mediate the efficacy of the motivational treatment~     but not of the reduction treatment.~   "
90967|NCT01866709|"~     It is hypothesized that SPS is more effective than placebo control (alternative hypothesis)~     in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 -~     6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).~   "
90968|NCT01866696|"~     Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23~     edentulous jaws treated with 3D software planning, guided surgery, immediate loading and~     restored with Cad-Cam Zirconia and titanium full arch frameworks.~      Material & methods: This study was designed as a prospective clinical trial. Twenty patients~     have been consecutively rehabilitated with an immediately loaded implant supported fixed~     full prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were~     placed , 22 of which in fresh post extraction sockets. All the implants were inserted with~     an insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other~     3 were delayed loaded.~      Outcome measures were implants survival, radiographic marginal bone-levels and bone~     remodeling, soft tissue parameters and complications.~   "
90969|NCT01866683|"~     Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a~     well-known positive effect on the cardiovascular system, it is our hypothesis that a~     respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate~     variability, electroencephalography, quality of life and salivary cortisol (stress hormone).~   "
90985|NCT01866475|"~     A prospective study to determine the safety of intraosseous (IO) access for a period up to~     48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal~     disease and/or controlled diabetes.~   "
90971|NCT01866657|"~     This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly~     patients undergoing thoracic surgical procedures that require the use of single lung~     ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring~     that have active intervention to mitigate observed desaturations will have measurable~     postoperative clinical outcome benefits when compared to the patients randomized to blinded~     cerebral oximetry monitoring with no active interventions to mitigate desaturations.~   "
90972|NCT01866644|"~     Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine~     (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree~     of dysfunction will be monitored by the method of LIMON, metabonomics techniques and~     according to the latest published validation Liver Transplantation (16 943-949 2010), total~     billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day~     and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days.~     Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7~     postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day~     (Olthoff et al Liver Transplantation 16,943 -949 2010).~   "
90973|NCT01866631|"~     The investigators hypothesise that the research data will enable them to elucidate local~     clinical practices with regard to breast cancer care and enable them to extrpolate the data~     to improved local clinical care for their patients through self-regulation and audit.~   "
90974|NCT01866618|"~     Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG.~     Patients will not be given any other stimulating medications during the cycle. They will~     have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine~     aspiration will be randomized to one of four days (day before retrieval, day of retrieval,~     day after retrieval or 2 days after retrieval). The second uterine aspiration and~     endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be~     biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent~     thaw cycle.~   "
90975|NCT01866605|"~     Patients are often anxious immediately before surgery. The investigators hypothesis is that~     a warming blanket is as effective as the sedative midazolam in allaying anxiety before~     surgery.~   "
90976|NCT01866592|"~     VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over~     subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is~     sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers.~     VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams,~     blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab~     injections following FDA-approved psoriasis treatment regimen.~   "
90977|NCT01866579|"~     Ethambutol is widely used as first-line drug, but has serious side effect of optic~     neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1~2%,~     there was considerable screening efforts and medical cost is increasing. However, there is~     no effective treatment of ethambutol optic neuropathy or no definite preventable measure.~     Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is~     emerging, more toxic secondary drug is used in the long-term.~      It is known that retinal nerve fiber layer is increased early stage in ethambutol optic~     neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by~     optical coherence tomography in longitudinal manner.~   "
90978|NCT01866566|"~     Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune~     procedure we could supply scientific and practical evidence for this two doses immune~     procedure promotion and management.~   "
90979|NCT01866553|"~     The purpose of this trial is to assess the effect of switching CML patients, who have been~     treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease~     between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the~     proportion of patients who achieve confirmed MR4.0.~   "
90980|NCT01866540|"~     This research during the last decade has focused on the kinetics of the systemic and local~     immune response to parenteral influenza vaccine in humans. The investigators have shown that~     normally high numbers of influenza specific antibody secreting cells (ASC) are present in~     the nasal mucosa of healthy adults but upon parenteral vaccination the numbers remain~     stable. However, a rapid transient increase in specific ASC is observed in the tonsils and~     peripheral blood after parenteral vaccination. In the tonsils, this is associated with a~     significant decrease in both naïve/effector (CD45RA+) and memory (CD45RO+) CD4+ cells upon~     vaccination. In this study the investigators will extend our work to investigate the~     characteristics of influenza-specific T- and B-cells induced locally and systemically after~     intranasal vaccination in man.~   "
90981|NCT01866527|"~     Early treatment is considered essential for developmental dysplasia of the hip (DDH), but~     the choice of screening strategy is debated. The investigators evaluated the effect of a~     selective ultrasound (US) screening programme.~      All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e.~     clinical hip instability, breech presentation, congenital foot deformities or a family~     history of DDH, were subjected to US screening at age one to three days. Severe sonographic~     dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild~     dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were~     followed clinically and sonographically until spontaneous resolution, or until treatment~     became necessary. The minimum observation period was 5,5 years.~   "
90982|NCT01866514|"~     This will be a prospective, non-controlled study using healthy adult volunteers as subjects~     receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the~     insertion technique and IO infusion flow rates.~   "
90983|NCT01866501|"~     A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus~     Intraosseous Vascular Access Insertion Site~   "
90984|NCT01866488|"~     The current study is a randomized, controlled, double-blinded trial of Obstetric Cook~     Catheter combined with oral misoprostol for induction of labor in pregnant patients. The~     primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in~     combination with oral placebo and the Obstetric Cook Catheter in combination with oral~     misoprostol. Secondary outcomes to be studied include the safety of the method, composite~     maternal morbidity and composite neonatal morbidity.~      The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive~     both the Obstetric Cook Catheter and the oral misoprostol.~   "
90987|NCT01866449|"~     The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of~     cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after~     last temozolomide treatment (Figure 1).~      Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard~     concomitant medication (as outlined below):~        -  On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m²,~          administered by i.v. route in 1 hour.~        -  Cycle length for cabazitaxel is 3 weeks (21 days).~        -  New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3,~          platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have~          recovered to baseline.~        -  A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.~        -  Patients should come off treatment if treatment delay is more than 2 weeks.~      At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v.~     premedication including:~        -  An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In~          case of i.v. antihistamine other than promethazine is not being available, local~          practice should be followed.~        -  Corticosteroid (dexamethasone 8mg or equivalent)~        -  H2 antagonist (ranitidine or equivalent).~        -  Antiemetic prophylaxis is recommended and can be given orally or intravenously if~          necessary.~        -  Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given~          on day 4 of each treatment cycle as per ASCO and ESMO guidelines.~   "
90988|NCT01866436|"~     To practice independently surgeons require competency in surgical skills, encompassing a~     combination of technical and non-technical skills. Cognitive skills, aspects of~     non-technical skills, represent an integral component of surgical competency. Cognitive~     skills comprise factual knowledge and decision-making.~      Changing work patterns in the United Kingdom, as specified by the European Working Time~     Directive (EWTD), have had a profound impact on the delivery of surgical skills training.~     Surgical trainees are now increasingly removed from normal working hours in which the~     majority of traditional operative training and experience is gained, leading to a net~     reduction in trainees' operative exposure. This reduction in operative experience means that~     surgical competence can no longer be assured on the basis of experience alone.~      Although there is no educational technology that can replace the craft apprenticeship~     required to train a competent surgeon, reduction in training hours has led to rapid~     development of educational tools to augment surgical skills training outside the operating~     room environment. These tools tend to concentrate on technical skills performance without~     emphasis on cognitive skills.~      Trainees in today's era have grown up in a multimedia environment; multimedia is media that~     uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped~     educational resource that can supplement cognitive skills training in operative surgery.~      The purpose of this study was to design and develop an online multimedia educational tool in~     a common colorectal surgery procedure (Anterior Resection) and determine the effectiveness~     of this tool in teaching and assessment of cognitive skills.~      Study hypothesis: Multimedia learning is equivalent to conventional teaching Study Day in~     improving scores in cognitive surgical skills.~   "
90989|NCT01866423|"~     This phase II trial studies how well orteronel works in treating patients with metastatic~     hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
90990|NCT01866410|"~     This phase II trial studies how well cabozantinib-s-malate and erlotinib hydrochloride works~     in treating patients with previously treated metastatic non-small cell lung cancer.~     Cabozantinib-s-malate and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the~     growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving~     cabozantinib-s-malate together with erlotinib hydrochloride may be an effective treatment~     for non-small cell lung cancer.~   "
90991|NCT01866397|"~     Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against~     herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro~     studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis~     in patients with AIDS and as a second line therapy for HCMV infections not responding to~     ganciclovir or foscarnet.~      In intensive care patients continuous venovenous haemofiltration (CVVH) is a~     well-established extracorporal renal replacement therapy with a high clearance rate.~      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH~     are rare. Elimination of any given drug by renal replacement therapy is determined by~     several major factors which are membrane specific, due to physico-chemical properties of the~     drug and characteristics of the renal replacement technique used.~      Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir~     during CVVH in critically ill patients. It is suspected that Hemofiltration will influence~     cidofovir plasma levels.~   "
90992|NCT01866384|"~     Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage~     (IPH) is common and associated with neurological deterioration and poor clinical outcome.~     Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with~     reduction or improvement of physiopathologic processes associated with inflammatory~     activation and degradation of blood-brain barrier after all types of brain injury. In this~     sense, we believe that the initiation of an ultra-early protocol of active temperature~     modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH,~     32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral~     edema after IPH by modulation of systemic and local inflammatory responses, so we~     hypothesize that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and~     cerebral edema after IPH.~   "
90993|NCT01866371|"~     Studying the morphology and function of the normal and diseased retina in vivo is needed for~     advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an~     adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased~     retina with individual cellular resolution non-invasively. The primary objective of this~     study is to obtain and analyze high-resolution images of the retina, in particular by~     imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The~     study design will involve case-control studies, where cases are followed over time. Subjects~     age 7 and older may be invited to participate. The main research procedure involves retinal~     imaging with the AOSLO. The primary endpoint is the observation of differences in retinal~     images between subjects with and without retinal diseases. These changes will be quantified~     by examining the cell density, size, spacing and regularity of the cone photoreceptor~     mosaic, as well as examining the differences between other retinal layers.~   "
90994|NCT01866358|"~     Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated~     resuscitation~   "
91210|NCT01863355|"~     Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for~     postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is~     currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background~     infusion rate) for effective pain control with minimal side effects such as nausea and~     vomiting~   "
90995|NCT01866345|"~     The purpose of this investigation is intended to evaluate the efficacy of surgically~     facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root~     shortening, and occurrence of mucogingival side effects compared to conventional orthodontic~     therapy in patients undergoing orthodontic treatment to correct crowding and/or~     retroclination of their mandibular anterior dentition.~   "
90996|NCT01866332|"~     The purpose of this study is to determine the effectiveness of the addition of the use of~     Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional~     physical therapy.~   "
90997|NCT01866319|"~     This study will evaluate the safety and efficacy of 2 different dosing schedules of~     pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2~     schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or~     metastatic melanoma.~      Participants assigned to treatment with pembrolizumab could receive up to 2 years of~     treatment; if participants stopped treatment at 2 years and later experienced progression,~     they were eligible for a second course of treatment for up to 1 additional year. With~     Amendment 05, all Second Course participants will be treated with a fixed dose of~     pembrolizumab 200 mg Q3W.~   "
90998|NCT01866306|"~     The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers~     for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB)~     in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in~     order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part~     1 is a dose-finding study where healthy participants, and asthmatic participants, either~     concomitantly treated or not treated with a class of long-acting beta antagonists (LABA),~     undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker study where~     mild to moderate asthmatics undergo challenge with the most appropriate dose of RV16UB~     identified in Part 1, based on tolerability and viral effects.~   "
90999|NCT01866293|"~     This study is an open label phase I/II trial to investigate the safety and efficacy of~     Cabozantinib for patients with relapsed or refractory myeloma.~   "
91000|NCT01866280|"~     The purpose of this study is to test the effects of sleep and meal timing, independent of~     sleep duration, on glucose regulation and metabolic and hormonal control of energy balance~     in normal weight adults.~      This study will be a 4-phase, randomized controlled study of 5 days each in which~     participants will undergo 2 phases of late sleep times that differ in meal timing (normal or~     late) and 2 phases of normal sleep times that differ in meal timing (normal or late).~      The Aims and Hypotheses of this study are:~      Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response~     to altered sleep and meal timing.~        -  Hypothesis 1: There will be an interaction between sleep and meal time on glucose,~          insulin, and glucose and insulin area under the curve after the glucose tolerance test~          such that the late sleep/late meal will result in the worst metabolic profile, normal~          sleep/late meal and late sleep/normal meal will have an intermediate profile, and~          normal sleep/normal meal will result in the best metabolic profile.~        -  Hypothesis 2: There will be an interaction between sleep and meal time on leptin and~          ghrelin concentrations such that the late sleep/late meal timing phase will result in~          low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will~          have an intermediate profile, and normal sleep/normal meal timing will result in high~          leptin/low ghrelin.~      Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal~     timing.~      • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase~     compared to normal sleep timing.~   "
91001|NCT01866267|"~     This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30)~     HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable~     viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside~     Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse~     Transcriptase Inhibitor (NRTI)] and switch them to once-daily Selzentry® (600mg qd) plus the~     same 2 NRTIs.~   "
91002|NCT01866254|"~     The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as~     well as intrathecal morphine after cesarean delivery, with fewer side effects.~   "
91003|NCT01866241|"~     Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of~     third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior~     to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of~     third stage of labor~   "
91004|NCT01866228|"~     The time period from diagnosis through to the end of treatment is challenging for patients.~     Patients need information, assistance with decision making, and emotional and social support~     to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is~     especially anxiety-provoking for patients who will learn, for the first time, their~     treatment options and likelihood of being cured. This anxiety causes many patients to have~     difficulty remembering the important pieces of information that their cancer doctor tells~     them during this consultation. The main goal of this study is to demonstrate the benefits of~     giving cancer patients an audio-recording of their first consultation with their cancer~     doctor. The investigators will include newly diagnosed patients from cancer centres in~     Winnipeg and Calgary. The types of cancer that will be included in this study are brain and~     neuroendocrine. Patients with these types of cancer are more likely to have confused~     thinking, and therefore may have the most to gain from receiving their consultation~     recordings. The study will include 244 patients, and those who sign consent forms to~     participate will be assigned by chance to either receive their treatment consultation~     recording or not. Patients will receive their recording immediately after their~     consultation, and will be able to listen to the recording at any time either alone, or with~     family and friends. To figure out whether the consultation recording provides patients with~     benefits, the investigators will administer some questionnaires to patients at 1 week after~     the consultation, and again at 3 and 6 months after the consultation. These questionnaires~     will assess the following patient outcomes: i) anxiety and depression, ii) perception of~     being informed about the disease and treatment, iii) satisfaction with cancer care, iv)~     satisfaction with the doctor, and v) the extent to which patients are satisfied with their~     degree of involvement in treatment decision making. The investigators hypothesize that~     patients who receive their consultation recording will experience more benefits than~     patients who do not receive their consultation recording.~   "
91014|NCT01866098|"~     This study is designed to look at the effects of naltrexone on weight loss in individuals~     treated with antipsychotic medications. Naltrexone is an FDA approved medication for the~     management of alcohol dependence and drug dependence, but has not been fully evaluated for~     its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia,~     schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out~     how effective two different doses of oral naltrexone is on reducing body weight when~     compared to placebo (an inactive substance or sugar pill).~   "
91015|NCT01866085|"~     The study is designed to assess efficacy and subject satisfaction of two sling devices:~     Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.~   "
91005|NCT01866215|"~     A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in~     sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic~     de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced~     dyslipidemia.This study will evaluate~        1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed~          before fructose ingestion 1b) when exercise is performed after fructose ingestion~          Metabolic effects of exercise will be assessed in healthy male subjects by measuring~          fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose~          concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very~          low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled~          fructose meals~        2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion~          after exercise Healthy male subjects will be fed various fructose, glucose, lipid and~          whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The~          effects of meals' composition will be assessed after 24 hours by measuring~          intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy~          (MRS).~   "
91006|NCT01866202|"~     Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific~     antigens in blood and tumor tissue, and the potential use of these antibodies for future~     evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and~     to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.~      Methods: To take 20mls of blood from advanced breast cancer patients before a new course of~     anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition,~     Consent will be obtained to cut 10-15 tissue sections from their archival tumor specimens.~     Whenever possible, the blood taking will be timed such that no additional needle prick will~     be done specifically for the purpose of the study, by coinciding it with standard blood~     taking which is required for the patient's treatment.~      Importance of proposed research to science or medicine:Detection of tumor specific antigens~     in the blood may potentially reduce the need for more invasive biopsies for confirmation of~     diagnosis of cancer or follow-up of cancer in the future. The identification and development~     of antibodies specific to these tumor antigens or markers may offer future therapeutic~     options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as~     understanding the changes that occur in EMT signature in these circulating tumor cells may~     serve as a means of potential means of prognostication and modification of therapy in the~     future.~      Potential Benefits and Risks: Potential risks to the patient include that of blood taking~     (pain, feeling faint, infection). Patients will not benefit directly from the study but the~     knowledge gained may help the management of future patients.~      Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to~     developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now~     able to be identified and isolated that may specifically target progenitors of breast cancer~     as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of~     prognostication, as well as allow for therapeutic modifications. Clinical correlative~     studies into these areas (MAbs and CTCs) will serve to determine the role of these in~     clinical application in the future.~   "
91007|NCT01866189|"~     This study is a French multicenter prospective study including 5 stroke units with available~     MRI and F-MISO PET for patients with acute ischemic stroke.~      Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic~     tissues in animals and stroke patients. While MRI has become the gold standard acute stroke~     imaging, no published study has compared FMISO PET and MRI.~      The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute~     ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic~     cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.~   "
91008|NCT01866176|"~     The purpose of this study is to evaluate the immediate effects of a knee brace with a new~     mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis~     patients. The effects of this new brace is compared to a stabilizing brace and a typical~     valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear~     each of the three braces during three months. A fifteen days wash-out period is given after~     each three months. Biomechanical evaluation is carried out before and after each three~     months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome~     Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a~     6-min walk test. During motion analysis, ten gait trials are executed without brace and ten~     with the brace.~   "
91009|NCT01866163|"~     The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of~     treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.~   "
91010|NCT01866150|"~     This cross-sectional, non-interventional, retrospective chart review will compare the~     efficacy and safety of biologic monotherapy and biologic and methotrexate combination~     therapy in patients with rheumatoid arthritis who have had an inadequate response to prior~     treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be~     collected from patients who have been on first-line biologic treatment for at least 6~     months.~   "
91011|NCT01866137|"~     The aim of the PsyCo Study is to determine whether psychological Stress has an influence on~     copeptin levels.~   "
91012|NCT01866124|"~     The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer~     program in the framework of a safety net to prevent acute malnutrition by children under 24~     months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region~     of Burkina Faso, Africa). The program will be targeted to economically vulnerable households~     with children less than 1 year old at the time of inclusion and the cash distributed to~     mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries'~     self-determination on the use that will be made of cash. This study will be designed as a~     two-arm cluster randomized intervention trial, based on randomization of rural villages of~     the Tapoa province. One arm will receive the intervention and one will be a control arm. The~     main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the~     cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as~     well as indicators of dietary diversity, food security, health center frequentation,~     families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be~     analyzed. Finally, based on a model theory framework built a priori, the pathways used by~     the cash to have an effect on the prevention of under-nutrition will be assessed.~   "
91013|NCT01866111|"~     This is a multicenter, double-blind, randomized, placebo-controlled dose response study,~     with an 8-week prospective baseline and an 18 week double-blind treatment period (including~     a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study~     drug taper period (for subjects leaving the study) or a 2-week blinded conversion period~     (for subjects who will participate in the open-label extension).~      The primary objective of this study is to determine the effective dose range of YKP3089 as~     adjunctive therapy for the treatment of partial seizures.~      The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy~     population.~   "
91016|NCT01866072|"~     Transient elastography is novel non-invasive method for assessment of hepatic fibrosis in~     patients with chronic liver disease, by measuring liver stiffness. Transient elastography is~     a user friendly technique that can be easily performed at bedside or in outpatient clinic~     with immediate results and good reproducibility.~      Liver stiffness values ranges from 2.5 to 75 kPa with lower values <6kPa suggest no fibrosis~     where as higher values above 14kPa suggests cirrhosis. In the present study the~     investigators hypothesis that the investigators can differentiate ACLF and acute severe~     viral hepatitis based on fibroscan as patients with underlying fibrosis with superadded~     inflammation would have higher fibroscan value than when patient have only inflammation with~     no underlying fibrosis and hence the investigators can avoid unnecessary test in such~     subgroup.~   "
91017|NCT01866059|"~     This study will involve filling teeth which have decay on their roots with three different~     filling materials. Patients will attend Cork University Dental School and hospital for a~     clinical examination and to complete a questionnaire describing how they feel about the~     comfort and appearance of their teeth. Patients will be asked to provide a sample of saliva~     by spitting into a tube. This saliva will be tested to see what levels of bacteria are~     present and how well their saliva neutralises acid in their diet. This is used to assess how~     high or low the patient's risk of dental decay is. They will also complete a questionnaire~     about the amount of sugar in their diet and how often they clean their teeth. If the exam~     shows that any teeth are so decayed that they cannot be filled, the patient will then be~     offered extraction of these teeth. All treatment will be discussed with the patient.~     Patients will be randomly assigned one of the three materials and this material will be used~     for their fillings. Patients will not know which of the three materials they received but~     all three materials are already in use in dentistry and all of the elements of each~     treatment plan are well recognised, routine dental procedures. After all the treatment has~     been completed, each patient will be shown how best to take care of their teeth and how to~     manage their sugar intake to reduce their risk of further decay.~      Patients will be given appointments to return for review at 6 months, 12 months, 18 months~     and 24 months after treatment. This will include a dental examination and dental impressions~     will be taken. These are used to measure how the restorative materials wear over time.~     Patients will also be asked to complete again the two questionnaires that they completed at~     their first visit to see if any of their answers have changed.~   "
91018|NCT01866046|"~     This is a developmental study evaluating a new rapid HIV testing and risk prevention~     intervention for residents of battered women's shelters who endorse risky sexual behaviors.~   "
91019|NCT01866033|"~     The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and~     the effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.~   "
91020|NCT01866020|"~     Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high~     morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols~     for haemato-oncological patients are not applicable for critically ill patients in ICUs.~     Definitive discrimination between aspergillic colonisation and IPA often depends on the~     clinical experience of the treating physician, evaluating clinical signs, co-morbidities,~     and course of the disease. Life saving treatment with the first line antimycotic Voriconazol~     (Vfend®) can only be initiated after diagnosis of IPA.~      In this prospective clinical trial the investigators aim to structure, optimize and fast~     track the diagnostic pathway of IPA in critically ill patients treated in our~     ICU-department.~   "
91021|NCT01866007|"~     The purpose of this study is to evaluate the pharmacokinetic (what the body does to the~     medication) comparability of guselkumab in lyophilized and liquid formulations. Also to~     evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as~     prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe~     facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration~     of 100 mg guselkumab in healthy participants.~   "
91022|NCT01865994|"~     The purpose of this study is to determine the measuring accuracy of the truly non-invasive~     method estimated continuous cardiac output (esCCO) against the reference method~     transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the~     pulse wave transit time, which is defined as the time between the R-wave of the ECG and the~     30% increase of the differentiated pulseoximetry waveform.~   "
91023|NCT01865981|"~     Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life~     threatening conditions affecting otherwise healthy young individuals. Due to the~     inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells~     causing the rhythm disturbance can be difficult to study in detail and therefore in many~     cases remain untreatable. The investigators propose to study heart cell electrical function~     from such patients by reprogramming skin cells to become stem cells and then differentiating~     them to heart muscle cells.~      The hypothesis of the study is that the differentiated cardiac cells will display electrical~     abnormalities dependent on the mutation causing the disease. These abnormalities can~     therefore provide a clue as to the nature of the mutation causing the disease or information~     about its effective management~   "
91024|NCT01865786|"~     This is a prospective, observational study to describe pregnancy outcomes among HIV-1~     uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate~     (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the~     Antiretroviral Pregnancy Registry (APR).~      Information on subjects is provided to the APR prospectively (prior to the outcome of the~     pregnancy being known) through their healthcare provider, with follow-up obtained from the~     healthcare provider following determination of the pregnancy outcome.~   "
91034|NCT01865656|"~     To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn~     Care (EmONC) skills and drills intervention, to estimate the appropriateness and~     effectiveness of referrals in intervention arm compared to control arm and to calculate the~     incremental cost and cost effectiveness of EmONC skills and drills intervention.~   "
91035|NCT01865643|"~     The aim of this study is to compare the hemodynamic response to tracheal intubations using~     the standard technique versus the alternative GS intubation technique. As secondary outcomes~     the investigators will analyze procedure time, success rate and injury rate.~      The investigators hypothesize that the alternative intubation technique will have a shorter~     procedure time and lower injury rate when compared to the standard technique of GS~     intubation.~   "
91025|NCT01865773|"~     A major limitation of standard hemodialysis is that it does not clear the plasma from~     interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular~     risk in end stage renal disease (ESRD). In the present study, we evaluated whether these~     compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the~     ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge.~     We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240~     minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by~     comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol~     levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start~     or at the end of the HFR session. The proinflammatory activity of UFin and UFout was~     determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid~     (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8~     healthy volunteers and cultured in vitro for 24 hr.~   "
91026|NCT01865760|"~     With increasing rates of obesity the number of anti-obesity operations performed is~     increasing; one of the most common is gastric bypass. Anti-obesity surgery ameliorates~     diabetes and several other serious comorbidities, but bariatric surgery is also associated~     with medical and nutritional complications.~      Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious~     complication often seen months to years after gastric bypass surgery. The patients~     experience neuroglycopenic symptoms (eg. inability to concentrate, weakness, altered mental~     status, loss of consciousness).~      The purpose of this study is to determine whether glucagon-like peptide-1 (GLP-1)or other~     enteropancreatic factors (eg. gastric emptying rate) are responsible for the excessed~     insulin secretion seen in some patients after bariatric surgery.~   "
91027|NCT01865747|"~     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with~     Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in~     subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine~     kinase inhibitor therapy.~   "
91028|NCT01865734|"~     Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical~     therapy practice and often is associated with chronic symptoms, and disability. Persistence~     of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to~     reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of~     care for PHP. Two practice guidelines are available to direct management patterns, but the~     guidelines and recent evidence of PHP interventions are unclear about the timing and~     influence of physical therapy in the multidisciplinary management of PHP. The purpose of~     this investigation is to compare the outcomes and costs associated with early physical~     therapy (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD)~     in individuals with PHP. It is hypothesized that there will be greater improvement and/or~     reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP~     will be randomized to receive uPOD or ePT after an initial visit with a podiatrist.~     Treatment provided in the uPOD group will reflect usual management patterns and intervention~     will be determined by the podiatrist. Treatment provided in the ePT group will be determined~     by the physical therapist and will focus on impairment-based manual therapy and exercise to~     the lower half of the body. In addition, evidence-based pain modulating modalities will be~     integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle~     Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale~     (NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The~     association between successful outcome based on GROC score and patient expectation of~     physical therapy or podiatry, and general expectations of symptom improvement will be~     analyzed. The results of this investigation will help to determine the impact of ePT to~     inform practice, update existing guidelines to reduce practice variation, and identify the~     most cost effective treatment for patients with PHP.~   "
91029|NCT01865721|"~     This study will randomise patients undergoing screening colonoscopy to receive Entonox~     either continuously or as required.~      Both these methods are used in the published studies of Entonox and in clinical practice.~      Null hypothesis There will be no difference in pain levels between these two methods of~     Entonox administration~   "
91030|NCT01865708|"~     Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood~     alcohol concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.~      Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or~     increased urinary white cells.~   "
91031|NCT01865695|"~     Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine~     insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing~     potential impairment on an individual's quality of life. Creon, a pancreatic enzyme~     supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for~     this condition. However, there has been limited work evaluating the merits of this~     medication in this condition. This study aims to evaluate the benefits that Creon may have~     in coeliac patients with low faecal pancreatic elastase by randomising patients with low~     faecal pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome~     measures that we aim to assess to determine the benefits of Creon include evaluation of~     stool frequency, abdominal pain, body mass index (BMI) and quality of life.~   "
91032|NCT01865682|"~     The purpose of this study is to quantify changes in ankle and knee motion and force~     resulting from five progressive modifications to the anterior-posterior trim lines of~     thermoformed ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most~     anterior trim line will prevent the most plantar flexion during loading response (the first~     10% of the gait cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50%~     of the gait cycle) as compared to the non-device condition. This will be evidenced by the~     sagittal plane ankle motion and ground reaction force magnitude and location during loading~     response and terminal stance. Additionally, the angular velocity of knee flexion will~     increase during these same periods. By contrast, as the trim lines are moved more posterior~     this will result in lowering the effective stiffness of the device which will result in~     progressive increases in dorsiflexion and allow increasing amounts of knee flexion during~     terminal stance.~   "
91033|NCT01865669|"~     Women with advanced maternal age and morbid obesity, have a higher incidence of labor~     induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum~     hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin~     receptor (OTR) desensitization has been recognized in the context of prolonged labors~     secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin~     desensitization specifically affects contractility in women with advanced maternal age and~     morbid obesity when compared to younger or normal weight populations. Further it is not~     known if the higher incidence of PPH seen in these women is due to poor uterine~     contractility and/or poor response to oxytocin.~      The investigators hypothesize that women with advanced maternal age and morbid obesity will~     exhibit poor myometrial contractility as compared to women that are younger and of normal~     body habitus, in both oxytocin pre-treated and untreated myometrium.~   "
91036|NCT01865630|"~     Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a~     ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of~     life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age~     adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a~     disproportionately larger percent of overall stroke morbidity and mortality due in part to~     the young age of those affected. If one is fortunate enough to survive the initial bleeding~     episode and the subsequent surgical treatment of the aneurysm, a patient may still develop~     secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most~     significant cause of morbidity and mortality after SAH and may be potentially preventable.~     Currently, there is only one medication (an anti-hypertensive) that has convincingly shown~     to improve outcomes after SAH. The molecular pathway causing these delayed strokes is still~     not clear, and this is an active area of research.~      Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation~     molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented~     experimentally by a TNFa blocker called etanercept. This clinical study, utilizing~     prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this~     drug and determine its effectiveness in preventing delayed strokes.~   "
91037|NCT01865617|"~     This phase I/II trial studies the side effects and best dose of laboratory treated T cells~     to see how well they work in treating patients with chronic lymphocytic leukemia,~     non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or have not~     responded to treatment. T cells that are treated in the laboratory before being given back~     to the patient may make the body build an immune response to kill cancer cells.~   "
91038|NCT01865604|"~     The aim of the study is to investigate whether there is a polarity-specific influence of~     tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.~   "
91039|NCT01865591|"~     The aim of this study is to assess the potential therapeutic benefit of catheter-based renal~     sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility~     trial.~   "
91040|NCT01865578|"~     Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor~     dependent neuronal transmission. Furthermore, they often have cognitive deficits of~     different magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in~     decreased cortical synaptic plasticity. Thus, this represents one major reason of cognitive~     deficits. Synaptic plasticity can be assessed in humans via the non-invasive technique of~     transcranial magnetic stimulation (TMS).~      The current study aims to investigate whether learning ability and also cortical plasticity~     can be changed by applying sessions of transcranial direct current stimulation (tDCS).~     Therefore, we are recruiting 10 to 15 patients suffering from anti-NMDA receptor~     encephalitis as well as healthy controls in order to compare tDCS effects. Learning ability~     is assessed by motor sequence tasks, whereas cortical plasticity is measured via TMS.~      tDCS is a novel non-invasive technique allowing induction of changes in cerebral~     excitability level and also cortical plasticity. Previous studies showed positive outcome of~     anodal stimulation on learning tasks. Especially motor learning seems to be an important~     target for tDCS treatment since it showed best results for both post-stroke patients and~     healthy subjects. Multiple sessions of tDCS are inducing long-term effects and improved~     learning function, which were present three months after stimulation.~      In this study we hope to reveals new insights into the pathomechanisms of impaired cognitive~     and learning abilities in patients having anti-NMDA receptor encephalitis. Moreover, we~     evaluate whether tDCS is an effective treatment for patients with cognitive and learning~     deficits.~   "
91041|NCT01865565|"~     Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma~     tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST~     patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective,~     multicenter, open, observational study in evaluation of safety and efficacy of imatinib~     compared with that of historical data for locally unresectable advanced GIST without~     metastasis. The study will include an up to 28-day screening period, followed by receiving~     imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after~     surgery.~   "
91042|NCT01865552|"~     The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of~     SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.~   "
91043|NCT01865539|"~     A randomized sham controlled trial evaluating the efficacy of the use of custom foot~     orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes~     that those veterans with chronic lower back pain who receive the custom foot orthotics will~     show greater improvements in pain and disability associated with the chronic lower back pain~     than those who receive the sham orthotic.~   "
91044|NCT01865526|"~     The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic~     kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are~     complex and the patients' compliance is very low. A dietary interview method is a validated~     instrument to evaluate the patients' compliance; however, it the presence of a dedicated~     dietitians. For these reasons, and because of the absence of dedicated dietitians in many~     nephrology centres, it is usual practice to give standard low protein diets to CKD patients~     not on dialysis.~      Aim of this study was to verify if few simple tips were able to reduce protein, phosphate~     and sodium intake in patients with CKD, as compared to the practice of giving a low protein~     diet elaborated by a renal dietitian.~   "
91045|NCT01865513|"~     International multicenter observational study of a random-sample cohort of patients~     undergoing any in-hospital surgical procedure under general or regional anaesthesia during a~     continued 14-day period of recruitment.~      Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents,~     or neuromuscular monitoring increases the incidence of postoperative pulmonary~     complications. The secondary hypothesis is that the use of muscle relaxants increases~     in-hospital mortality.~   "
91386|NCT01861041|"~     Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose~     hyperbaric local anesthetics have been used to enhance the resolution of the spinal block.~     We compared the efficacy and duration of the spinal block with two different bupivacaine~     baricities.~        -  Group I: low dose isobaric group~        -  GroupII: Low dose hyperbaric group~   "
91387|NCT01861028|"~     This study compares intraoperative fit of the patient-specific iTotal knee replacement to~     other standard knee replacement implants~   "
91046|NCT01865500|"~     Chronic obstructive pulmonary disease (COPD) is a common disease that has a chronic and~     progressive course. Patients with COPD may have exacerbations one to four times in a year.~     Numbers of exacerbations are important because of increased morbidity and mortality and~     healthcare costs.~      Systemic corticosteroids (SC) are recommended in the management of exacerbations of COPD as~     well as bronchodilator, oxygen and antibacterial treatment by all international guidelines.~     However, there are still some concerns about systemic corticosteroid use because COPD~     patients are older and relatively immobilized. In addition, exacerbation rate is~     significantly higher in a group of COPD patients, and these patients need higher amounts of~     SC in order to control of exacerbation. It results in some adverse effects such as~     osteoporosis and bone fractures, thinning of the skin, posterior subcapsular cataract~     formation, glucose intolerance and myopathy. Thus, this condition leads clinicians to seek~     alternative options. However, there are few studies showing that nebulized steroids (NS) are~     as effective as SC in exacerbations of COPD and the optimal NS dose is not certain.~      The investigators aimed to determine the optimal NS dose and evaluate the efficacy and~     safety of NS compared with SC in the treatment of patients with COPD exacerbations requiring~     hospitalization.~   "
91047|NCT01865487|"~     This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and~     regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV~     negative, and have no history or evidence of TB disease. The investigational product is~     AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine~     is administered by IM injection.~   "
91048|NCT01865474|"~     This is a prospective, double-blind, randomized, and controlled study. The investigational~     product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week~     course of therapy.~      DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic~     activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes~     mellitus patients.~      Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen~     level of diabetes mellitus patients better than that of the Control Group.~   "
91049|NCT01865461|"~     MRI, without any contrast injection, allows a non-invasive evaluation and quantification of~     hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads,~     but in certain clinical circumstances, cases require to improve performances. The aim of the~     study is to add to MRI scans which currently must be performed innovative sequences~     appropriate for the clinical question to overall appreciate on a varied range of patients~     their quality, their robustness, their relative performance and, for patients having a~     biopsy, their accuracy.~   "
91050|NCT01865448|"~     Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to~     assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to~     increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the~     biological markers of chronic inflammation in obese patients following a weight-loss~     programme.~   "
91051|NCT01865435|"~     Actually, there is an increasing number of arguments for a premature origin of chronic~     adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors~     interacting with the foetal or postnatal lung growth are associated with early and~     long-lasting respiratory functional changes susceptible to contribute very significantly to~     the arisen of a COPD in the adulthood. It is possible that these situations reflect~     phenomena of premature cellular senescence, recently involved in the physiopathology of the~     COPD. An in utero exposition to cigarette smoking is one of these situations, because it is~     known to induce, not only functional respiratory changes, but also multiple diseases in the~     child which could testify of cellular ageing phenomena.~      Our project aims to demonstrate that in utero smoking is associated with markers of~     premature cellular senescence in newborn children~      The study will be driven in human newborn child's, with comparison of the length of the~     telomeres in circulating lymphocytes (umbilical blood is collected), according to the~     exposure in in utero smoking and also according to the degree of hypotrophy. This study will~     be a pilot study completed by an animal experimental study.~   "
91052|NCT01865422|"~     Cough is one of the most common reasons for consultation. Even if cough is a non-specific~     symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated~     that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to~     evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL~     chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A.~     B.~      Objective : The aim of the study is to validate the French version of the PC-QoL, a~     parent-proxy QoL chronic cough specific questionnaire.~      Methods : Linguistic validation will be performed using backward/forward translation~     guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested~     in 150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4~     weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. Informed~     consent from parents will be obtained. At enrollement, each parent will fulfill the PC-QOL~     questionnaire and two cough-related measures (visual analogue score, verbal category~     descriptive). Clinical data (medical history, physical examination) will be collected.~     Children QoL will be assessed using VSPA, Kidscreen and Qualin questionnaires. For assessing~     reproductibility and sensitivity to change, parents will be retested 7 and 21 days later.~     Content validity, construct's validity, external validity and instrument's reliability will~     be explored.~   "
91053|NCT01865409|"~     Physiological processes leading to a preterm infant to be able to feed orally has not been~     fully understood. The investigators hypothesized that maturation of autonomic nervous system~     may play a major role in this process and kangaroo care may accelerate this maturation. The~     investigators will use heart rate variability to measure the maturation of autonomic nervous~     system.~   "
91075|NCT01865110|"~     This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance~     improves progression free survival (PFS) compared to standard rituximab maintenance after~     induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60~     year old) with mantle cell lymphoma.~      The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28~     alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of~     rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).~   "
91054|NCT01865396|"~     The World Health Organization (WHO) defines palliative care as an approach to improve the~     quality of life of patients and their families facing life-threatening illness, through~     prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO~     stresses that palliative care is applicable early in the course of the illness together with~     other therapies that are intended to cure or prolong life, such as chemotherapy or radiation~     therapy. For the benefit of the patient, palliative care is however often given (too) late~     in the course of the disease of incurably ill patients.~      The aim of our study is to measure the effect of interventional palliative care on quality~     of life, mood and end-of-life care of patients with advanced cancer and their families.~     These patients have a limited life expectancy and a high symptom burden, this leads us to~     suggest that these patients may be benefited with palliative care soon after diagnosis of~     metastatic disease (interventional palliative care).~      The research design of this study is a randomized controlled trial with, on the one hand, an~     intervention group in which patients and their families receive interventional palliative~     care in combination with standard cancer care and on the other hand a control group in which~     patients and their families receive only standard oncologic care. Participants in the~     intervention group will meet the palliative support team shortly after diagnosis.~     Afterwards, the palliative support will meet them at least once a month. This intervention~     focuses on topics such illness understanding, symptom management, decision making and coping~     with the disease. Participants in the control group will only meet with the palliative~     support team at the patient's own request or after referral by the oncologist or the nursing~     staff.~   "
91055|NCT01865383|"~     Young men who are members of the camps randomized to receive a microfinance and health~     leadership intervention will have a lower incidence of sexually transmitted infections~     (Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) and~     report perpetrating less physical or sexual violence against sexual partners as compared to~     young men who are members of camps not randomized to receive the intervention.~   "
91056|NCT01865370|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.~     The investigators measured improvement of blood lipids parameters , including Total~     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.~   "
91057|NCT01865357|"~     Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS).~     Cognitive deficiencies could occur at this early stage and concern mainly information~     processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor~     Imaging (DTI) can help in the understanding of these mechanisms.~   "
91058|NCT01865344|"~     To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS)~     and skin conductance responses per second at rest and in response to a painful stimulus.~     Sensitivity and specificity will be calculated for NRS and skin conductance responses per~     sec to a standardized painful stimulus. Furthermore, predictors of pain will be examined.~   "
91059|NCT01865331|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability and pharmacokinetic (the exposure of the trial drug in the body) and~     pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin~     degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM),~     both explorative formulations, not similar to the proposed commercial formulation, in~     healthy male Japanese subjects.~   "
91060|NCT01865318|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec~     (insulin 454), an explorative formulation, not similar to the proposed commercial~     formulation, under single-dose and steady-state conditions in male subjects with type 1~     diabetes.~   "
91061|NCT01865305|"~     This trial is conducted in Europe. The aim of this trial is to compare different ratios of~     explorative formulations, not similar to the proposed commercial formulation, of IDegAsp~     (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately~     injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared~     with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.~      Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with~     type 1 diabetes where each subject will be randomised to five out of the ten possible~     treatments. Each treatment consists of an injection of the insulin product followed by a~     euglycemic clamp with a washout period of 7-15 days between treatments.~      Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with~     type 2 diabetes. Each treatment consists of an injection of the insulin product followed by~     a euglycaemic clamp with a washout period of 7-15 days between treatments.~   "
91062|NCT01865292|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics~     (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the~     trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not~     similar to the proposed commercial formulation, with insulin glargine in subjects with type~     1 and type 2 diabetes.~   "
91063|NCT01865279|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec~     (insulin 454), an explorative formulation, not similar to the proposed commerical~     formulation.~   "
91076|NCT01865097|"~     Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome~     non-motor symptom is pain. Currently these symptoms are treated with medication with limited~     success. Our study aims to determine whether relaxation guided imagery can alleviate pain in~     Parkinson's disease patients.~   "
91077|NCT01865084|"~     The main purpose of this study is to determine if tadalafil can slow the decline in walking~     ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the~     safety of tadalafil and any side effects that might be associated with it in boys who have~     DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks~     of the study, and can then continue into an open label extension (OLE) that consists of two~     periods during which all participants will receive tadalafil. In OLE period 1, all~     participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will~     continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.~   "
91064|NCT01865266|"~     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in~     ventilated critically ill patients specially in intensive care unit (ICU). It is associated~     with an increased duration of mechanical ventilation, high death rates and increased~     healthcare costs in the development country.~      Although VAP is preventable and many practices have been demonstrated to reduce the~     incidence of this disease, the morbidity is still so high. VAP is hard to cure and the~     mortality is about to 40% which was reported in China in 2004. If the bacteria of~     multidrug-resistance(MDR) is isolated, the mortality can increase to 70%. So much more~     methods should be needed in treating VAP in addition to using antibiotics.~      Ulinastatin is a serine protease inhibitor with a molecular weight of 67,000 found in~     healthy human urine. It is used worldwide for patients with inflammatory disorders,~     including disseminated intravascular coagulation(DIC),shock, and pancreatitis . Furthermore,~     ulinastatin administration can help reduce sepsis, prevent multiple organ dysfunction, and~     modulate immune functions.~      Actually, three studies have showed that ulinastatin treatment is associated with reduced~     the levels of inflammatory factors in blood serum in patients with acute respiratory~     distress syndrome(ARDS).Though analyses of serum inflammatory factors such as tumor necrosis~     factor (TNF)-α and interleukin (IL)-6 have been used to determine the degree of systemic~     inflammation under various clinical conditions, they can not reflect the degrees of lung~     infection directly.~      Basing on the results of previous studies, meta analyses and system reviews, the~     investigators hypothesized that the anti-inflammatory function of ulinaststin may also~     decrease the levels of inflammatory factors in bronchoalveolar lavage(BAL) fluid in Patients~     with VAP.~      In addition there is no prospective study to investigate the role of ulinastatin in BAL. The~     investigator hopes that this study can approve the relationship between ulinastatin and~     inflammatory factors in BAL. And it can improve the processes,outcomes and costs of critical~     care as well.~   "
91065|NCT01865253|"~     This is an observational proof of concept study investigating the safety and effectiveness~     of renal denervation to lower blood pressure in people whose blood pressure is not~     adequately controlled due to:~        -  intolerance to antihypertensive medication~        -  inability to take antihypertensive medication due to planned pregnancy~        -  renal artery stenosis~        -  chronic kidney disease~        -  non-compliance to antihypertensive medication~      A total of 125 participants, 25 from each of the groups mentioned above will be recruited to~     the study.~      The duration of this study is 36 months.~   "
91066|NCT01865240|"~     This is a study investigating the effectiveness of renal denervation in lowering blood~     pressure in people whose blood pressure is not adequately controlled despite treatment with~     3 or more blood pressure lowering drugs. The study is designed to compare the effects of~     renal denervation to a usual care group receiving additional blood pressure lowering drugs.~   "
91067|NCT01865227|"~     Obesity has become a global epidemic causing enormous human and economic costs. Incidence~     rates have doubled over the last few decades and obesity-related illnesses such as diabetes~     and cardiovascular diseases now constitute one of the major contributors to the global~     burden of disability. Overall, obesity has been recognized as one of the most pressing~     public health concerns worldwide and effective treatment and prevention strategies are~     urgently required. While behavioral and pharmacological treatments (e.g.low calorie diets,~     medication) are successful means for overcoming overweight and mild obesity, more severe~     cases of obesity usually fail to respond to such interventions. As a result, the demand for~     weight loss surgery is growing among this population. However, uncertainties about the~     effectiveness of obesity surgery persist and high relapse rates (i.e. weight regain) are~     common. Further research in this field is needed to identify risk factors that may trigger~     relapse and to understand patients' treatment needs in greater depth. Previous studies have~     pointed toward high levels of mental health problems among patients. However, the impact of~     preoperative psychopathology on actual surgery outcomes remains unclear. Similarly, few~     studies have investigated the effect of postoperative therapy on patients' psychological~     functioning and weight loss patterns. Research addressing these gaps is imperative to~     establish best-practice approaches. This challenge applies in particular to Middle East and~     North Africa(MENA) countries where research in the field of bariatric surgery and related~     mental health is largely missing. This is a major concern given the fact that the MENA~     region experienced the highest increase in overweight and obesity in recent decades compared~     to other countries.~      The proposed study aims to address this deficiency by examining obesity surgery patients in~     two Arab countries (UAE and Jordan). The goals of the project are to investigate the nature~     and extent of psychological health concerns among these patients before and after surgery~     and potential associations with treatment outcomes. Moreover, it will test the efficacy of~     post-operative counseling to improve weight loss and psychological health. For this purpose,~     a randomized clinical trial design will be employed so that cause and effect relationships~     between postoperative counseling and treatment outcomes(i.e. weight loss and psychological~     functioning) can be examined experimentally. The study will start by assessing participants'~     psychological health prior to surgery by using standardized self-report measures.~      After surgery, participants will be randomly assigned to either the intervention condition~     consisting of 3-monthly post-operative medical checkups plus group counseling or the~     treatment as usual condition (i.e. 3-monthly standard medical checkups only). Additionally,~     participants' psychological health will be reassessed in both groups at 3, 6, 9 and 12~     months after surgery. The benefit of the experimental study design is that it allows~     comparing patient outcomes between groups while at the same time controlling for a wide~     range of potential confounding variables.~      The data collected are expected to make a significant contribution to the treatment~     challenge of one of the most pressing public health concerns worldwide. Study results will~     add to clinical practice by broadening and deepening our knowledge of the treatment needs of~     obese patients. By identifying psychological health concerns that may threaten successful~     treatment outcomes high-risk patient groups can be recognized early, which in turn may help~     to reduce postoperative weight regain and other complications.~      To the best of the PI's knowledge, the proposed work would be the first study of this kind~     in the Arab world. Findings will be helpful for developing culturally sensitive and~     evidence-based best-practice guidelines, which are vital to achieve satisfying long-term~     outcomes. Moreover, study results will be relevant for research communities and~     practitioners outside the MENA region since empirical support for the effectiveness of~     obesity surgery remains weak internationally.~   "
91068|NCT01865201|"~     It is hypothesized that excessive generation of free radicals involves in the pathogenesis~     of radiation-induced brain necrosis. This study therefore evaluated the effect of free~     radical scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients~     with nasopharyngeal carcinoma (NPC) after radiotherapy.~   "
91069|NCT01865188|"~     To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in~     combination with amlodipine in patients with essential hypertension.~   "
91070|NCT01865175|"~     This is a pilot study designed to compare the tolerance of ionic iron (ferrous sulphate)~     with heme iron polypeptide. Subjects will take one week of one product followed by a week~     with no product followed by a week with the other product. Subjects will complete a daily~     diary to assess side effects.~      Hypothesis: Heme iron polypeptide is associated with fewer gastrointestinal side effects~     than ionic iron.~   "
91071|NCT01865162|"~     The first weekly KD meal package will be given to the patient at the study site. The patient~     will be instructed in how to process the week-long meal plan package content. Participants~     will measure urine ketone bodies with Ketostix 2x day and blood for glucose and ketone~     levels using self-administered Precision Xtra® Meter (Abbot Diabetes Care, Alameda, CA, USA)~     starting with the first day of the diet. Self-administered blood checks for glucose and~     ketone bodies will be done in fasted state in the morning and 2 hours post-prandially in the~     evening. Participants will be seen on day 7 of treatment by the study nutritionist and a~     study investigator-physician (separately) to review possible AEs, and for further education~     about the diet. Study staff will review and evaluate the participant's method of urine~     ketone and blood glucose and ketone levels testing. Subsequently, participants will be seen~     at one, 2 weeks, and 4 weeks after KG diet initiation, and then monthly. KD treatment will~     last until exit criteria are met or for 6 months, whichever comes first. Exit criteria are~     the primary outcome measures, the first of either (a) cerebral edema requiring steroid~     rescue therapy or (b) death.~      Treatment will occur in outpatient office setting at the Mid-Atlantic Epilepsy and Sleep~     Center, Bethesda, MD. The location of subsequent treatment administration may change to~     hospital setting at Holy Cross Hospital should a patient need hospitalization during the~     study for any reason, as determined by the patient's clinical care needs.~   "
91072|NCT01865149|"~     Studies in patients with intracranial hypertension have shown a good relationship between~     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured~     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath~     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.~   "
91073|NCT01865136|"~     The aim of this project is to study the safety, efficacy and effectiveness of medical~     treatment of incomplete abortion provided to women by physicians or midwives in Kisumu,~     Kenya.~      In Kenya, Post Abortion Care (PAC), provided by physicians, nurse-midwives and clinical~     officers, has been integrated at private reproductive health facilities since 1998.~     Misoprostol as treatment of incomplete abortion was launched I Nyanza Province in April,~     2012. The involvement of midwives in medical (Misoprostol) treatment of incomplete abortion~     has, however, not been systematically evaluated. There is a need to determine whether~     midwives and physician can perform medical treatment of incomplete abortion equally safe and~     effective in Kenya. The results will thus provide evidence-based information that can~     contribute to the development of strategies to increase women's access to Post Abortion Care~     in Kenya as well as in other low-income contexts.~   "
91074|NCT01865123|"~     The purpose of this study is to compare the effectiveness of the Transcendental Meditation~     (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure~     (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month~     treatment period.~   "
91078|NCT01865071|"~     Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer~   "
91389|NCT01861002|"~     This is a Phase I study with a conditional cohort expansion phase to evaluate the~     feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine~     (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute~     myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to~     primary treatment or who relapsed.~   "
91079|NCT01865058|"~     Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with~     approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark~     accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of~     chemotherapy and monoclonal antibodies has significantly improved prognosis over the past~     decade, but a large proportion of patients with DLBCL will continue to relapse with our~     current treatment options. Therefore, there is a need for reliable methods for detection of~     treatment response as early as possible in the treatment course in order to identify~     patients who respond poorly to standard treatment and potentially would benefit from a~     change in treatment strategy. This has still not been established, but a valid early marker~     is required in order to allow randomized trials of treatment stratified by early response.~     One of the most promising applications of PET is the metabolic assessment of the early~     response of cancer treatment.~      This study is a national prospective multicenter study emanating from the Danish Lymphoma~     Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim~     is to establish the correct timing of response evaluation. Additionally, the investigators~     wish to investigate the optimal qualitative and quantitative method of response assessment~     in order to predict post-therapeutic remission and long-term prognosis.This study will~     contribute to interim-PET being implemented in the most optimal way in daily clinical~     practice.~   "
91080|NCT01865045|"~     This is a multicenter retrospective analysis .The aim of the present study is to investigate~     the molecular predictors of vinorelbine response in tumor samples of a series of MPM~     patients and evaluate the possible impact on clinical outcome.~      Sample size: around 150 patients based on the availability of tumor size~   "
91081|NCT01865032|"~     This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus~     the gold standard for Leishmania diagnosis in the US which is microscopic identification of~     Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for~     dermatology consultation with a primarily ulcerated lesion. After informed consent is~     obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected~     from the subject's lesion in the following order: 1) one sample will be obtained with a~     dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained~     by scraping for use in the microscopic identification of amastigotes. Samples will be~     analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be~     performed by different operators who are clinical staff members. These staff members,~     blinded to each other's results, will evaluate the samples from each method independently.~     Each of the 150 study subjects will be followed administratively to the point where a~     diagnosis is established (if possible) for their tested lesion, even if that diagnosis is~     not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL~     lesion, the investigator will assign a likely etiology (eg, infectious, oncological,~     immunological, vascular, or undetermined/other origin). Based on the diagnosis determined~     for each lesion, subjects will be referred for appropriate treatment.~   "
91082|NCT01865019|"~     pressure controlled ventilation will improve oxygenation indices , hemodynamics during~     anesthesia for living donor liver transplantation recipients ,improving postoperative graft~     function and decreasing postoperative pulmonary complications~   "
91083|NCT01865006|"~     The purpose of this study is to compare effect of sutureless thyroidectomy with vessel~     closure devices and conventional thyroidectomy with suturing on voice quality with~     phoniatric evaluation.~   "
91084|NCT01864993|"~     Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing~     gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and~     thus it represents an important issue in health care. Actually it remains difficult to~     diagnose and prove due to the lack of established criteria. The investigators intention is~     to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of~     patients suffering from functional gastrointestinal symptoms.~   "
91085|NCT01864980|"~     Certain types of surgery are associated with occult blood loss, which is hard to detect~     intraoperatively by intermittent conventional, invasive Hb concentration measurements using~     the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The~     investigators want to see whether continuous non-invasive transcutaneous Hb measurement~     using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a~     patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of~     red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2)~     possibly associated with transfusion below a critical haemoglobin concentration.~     Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC~     administration and reduces the need for intra- and post-operative RBC transfusion.~   "
91086|NCT01864967|"~     Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal~     and subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating~     local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth~     factor and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow~     in chronic wounds of the lower limbs.~   "
91087|NCT01864954|"~     This study seeks to develop and test a Web-based tobacco relapse prevention program~     targeting postpartum women who quit smoking for pregnancy. Participants are randomly~     assigned to one of two conditions: (1) an Enhanced Web+phone Condition that receives access~     to an interactive Web-based intervention plus up to 3 brief supportive phone calls from a~     personal coach; (2) A Basic Web Information-Only Control Condition that receives access to~     an informational website plus an introductory phone call. The hypothesis is that Women in~     the Enhanced Condition will be more successful in avoiding tobacco relapse than women~     assigned to the Basic Control Condition.~   "
91088|NCT01864941|"~     To investigate the safety and tolerability of balloon venoplasty compared to sham in~     Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as~     measured by adverse events occurring within 48 weeks of the procedure.~   "
91108|NCT01864681|"~     The purpose of this study is to determine whether metformin in combination with gefitinib~     are effective in patients with previously untreated advanced or metastatic Non-Small-Cell~     Lung cancer with epidermal growth factor receptor (EGFR) mutations~   "
91109|NCT01864668|"~     Measure the lung strain in different tidal volume in ADRS patients to find the relationship~     between tidal volume and lung strain and find the most suitable tidal volume for each~     patient.~   "
91089|NCT01864928|"~     Despite abundant evident supporting the use of acute reperfusion therapy in the setting of~     acute ischemic stroke (AIS), adoption of this practice in routine clinical care is poor. We~     hypothesize that a significant barrier is the difficulty in weighing the benefits and risks~     of rt-PA treatment in the care of an individual patient, a problem compounded by the time~     urgency of decision-making and clinical fears that weigh risks of treatment more heavily~     than benefits.~      The goal of this Quality Improvement (QI) study is to leverage an IT solution that we have~     developed, ePRISM, that executes multivariable risk models with patient-specific data so~     that a personalized estimate of an individual's outcomes (both risks and benefits) with and~     without rt-PA, can be generated so support safer, more effective clinical care. Through an~     earlier project, we will have programmed ePRISM with the best available risk-stratification~     models and developed a clinically useful format for presenting the data to support clinical~     decision-making in AIS.~      Through QI, we propose to identify the optimal mechanism for integrating the tool within the~     routine flow of patient care in preparation for more definitive studies, or dissemination~     strategies, to improve the treatment of patients with AIS.~   "
91090|NCT01864915|"~     Colon capsule endoscopy is a new technology that is a noninvasive method of examining the~     large bowel. The bowel preparation required for this test differs from colonoscopy in that~     it needs to clean the colon but also needs to provide propulsion. Most published studies~     have used medications as part of their regime that are not available in parts of North~     America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and~     polyp detection rates.~      Objective: In this study a bowel preparation for the colon capsule is proposed that uses~     medications approved for use in Canada that may provide a better preparation quality and~     better completion rates.~      Methods: Patients who are being referred for a colonoscopy will be recruited to participate~     in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel~     preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four~     days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3)~     Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon~     capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or~     approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results~     will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess~     the bowel preparation using a previously defined scale and examine for polyps. We propose~     that administering Prucalopride daily for 4 days will increase intestinal motility and~     improve colon capsule completion rates and a booster dose of Picosalax will improve colon~     capsule completion rates compared to prucalopride by itself.~   "
91091|NCT01864902|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem~     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
91092|NCT01864889|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to chemotherapy.~   "
91093|NCT01864876|"~     This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and~     tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF~     administered subcutaneously. The second focus will be to detail the global immune response~     by measuring systemic cytokines, chemokines, and global gene regulation. The third focus~     will be to investigate the effects of GLA on the peripheral blood immune cells including~     monocytes and dendritic cells. The results of this trial will generate supportive human data~     to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.~   "
91094|NCT01864863|"~     The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets~     and one HGP1206 125 mg tablet in healthy male volunteers.~   "
91095|NCT01864850|"~     Randomized comparison between standard radiotherapy and hypofractionated split course~     schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated~     split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment,~     acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the~     same efficacy, measured by the locoregional control rate.~   "
91096|NCT01864837|"~     The aim of the proposed study is to investigate the agreement between the measurement of the~     tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue~     coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).~   "
91097|NCT01864824|"~     In this study, the pills formulated are being used to try to ameliorate the effect of air~     pollution on epigenetic changes, specifically DNA methylation, potentially linked with~     particulate matter air pollution inhalation and cardiovascular health effects. The way in~     which this is achieved is that the vitamins, which act as methyl donors, add a methyl group~     to the DNA to reverse the loss observed on exposure to air pollution.~      Specifically for this study, the methyl donor supplement has been made by Jamieson~     Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health~     Canada approved limits) and 2.5 mg folic acid. The non-vitamin ingredients are those~     commonly used in pill formation. However, the folic acid concentration is 2.5mg, which is~     above the 1.0mg limit set by Health Canada for a natural health product. This concentration,~     however, has been used in previous academic studies safely and effectively, and was also~     formulated by Jamieson Laboratories. (ClinicalTrials.gov number, NCT00106886; Current~     Controlled Trials number, ISRCTN14017017. HOPE2 study).~   "
91098|NCT01864811|"~     A randomized control trial investigating if an early intervention program of modified~     Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age~     will improve hand function in children with risk for developing cerebral palsy.~   "
91390|NCT01860989|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg,~     225mg and 300mg/day~   "
91099|NCT01864798|"~     This is a prospective, single arm phase IIa trial in which patients with early breast cancer~     will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart~     (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be~     collected at baseline and at surgery. Post-operative treatment will be at the discretion of~     the investigator.~      Primary objective: to determine if a short course of RANKL inhibition with denosumab can~     induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry~     (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women.~      Secondary objectives:~        -  To determine the number of absolute Ki67 responders after a short course of denosumab~          (defined as <2.7% IHC staining in the post treatment tumor biopsy).~        -  To determine the effects of a short course of denosumab on serum C-terminal telopeptide~          levels (CTX).~        -  To determine the effects of a short course of denosumab on RANK/RANKL gene expression~          and signaling as assessed by immunohistochemistry (IHC) and gene expression profile in~          the tumor.~        -  To determine the effect of a short course of denosumab on tumor apoptosis rates using~          IHC~        -  To determine the effect of a short course of denosumab on modulating the immature~          mammary epithelial cell populations in the tumor.~        -  To determine the effect of a short course of denosumab on estrogen signaling pathways~          in the tumor.~        -  To determine the effect of a short course of denosumab on various immune - To determine~          effect of safety profile of denosumab~   "
91100|NCT01864785|"~     Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures~     are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains~     controversial. Treatment varies from the conservative management to various types of~     surgery. Internal fixation with spinal fusion is a surgical treatment method that is~     generally accepted for patients with thoracolumbar fracture. In this department, the~     investigators treat thoracolumbar burst fracture with posterior fixation alone and combined~     with articular process fusion. To evaluate the result of the two kinds of treatment, the~     investigators design this clinical trial. So, the investigators compared the radiological~     and clinical outcomes between patients who underwent posterior fixation alone and~     supplemented with fusion following the onset of thoracolumbar burst fractures.~   "
91101|NCT01864772|"~     The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of~     autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or~     metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty~     (after geriatric assessment).~   "
91102|NCT01864759|"~     The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in~     adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally~     replicative or oncolytic adenovirus.~   "
91103|NCT01864746|"~     The PENELOPEB study is designed to demonstrate that in the background of standard~     anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS)~     compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early~     breast cancer at high risk of relapse after showing less than pathological complete response~     to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in~     patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be~     an attractive option with a favourable safety profile for these patients.~   "
91104|NCT01864733|"~     The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite~     medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an~     independent risk factor for mortality and complications. Up-to-date, interventional studies~     involving nutrition are scarce in CHF. Academic societies are recommending the use of oral~     nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS~     could improve nutritional status in undernourished CHF patients, but solely administered,~     have a limited impact on undernutrition, physical performance and prognosis. A multimodal~     approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids~     (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the~     clinical benefits of such an approach in patients with chronic respiratory insufficiency~     (CRI), who have similar nutritional and muscular characteristics.~      Exercise rehabilitation is well validated in CHF patients, but has never been validated in~     case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality~     of life and cardiovascular outcomes including mortality.~      N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA~     supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be~     useful for CHF patients rehabilitation.~      Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly~     muscle strength, walking endurance and quality of life. In the context of a multimodal~     approach, Androgen substitution together with exercise rehabilitation and ONS could have a~     beneficial effect on muscle mass, strength and endurance of CHF patients, as already~     described in CRI, elderly and HIV patients.~      The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation,~     androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF~     patients.~   "
91105|NCT01864720|"~     Insomnia is very common in cancer patients. When left untreated, insomnia can lead to~     numerous serious consequences (e.g., psychological disorders) for the individual and~     significant costs for society (e.g., increased medical consultations). Cognitive-behavioural~     therapy (CBT), a form of psychotherapy, is now considered the treatment of choice for~     insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer~     patients. Unfortunately, CBT for insomnia (CBT-I) is not widely accessible as only a few~     cancer clinics have mental health professionals formally trained in the administration of~     this treatment. Innovative models of treatment delivery are therefore needed to make sure~     that every cancer patient with insomnia receives the care he/she needs. A stepped care~     approach in which patients only receive the level of treatment that they need, beginning~     with a minimal, less costly, intervention followed by more intensive treatment if required,~     has shown some promises for other psychological disorders (e.g., depression). Although its~     relevance has been emphasized to make CBT-I more accessible, its utility has never been~     investigated. The main goal of this randomized non-inferiority study is to assess the~     efficacy and costeffectiveness of a stepped care CBT-I as compared with standard care. Our~     hypothesis is that a stepped care approach will not be statistically inferior in terms of~     efficacy as compared to usual care, while being much less costly (better cost-effectiveness~     ratio). Three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be~     assigned to: (1) stepped care CBT-I (n = 200) or (2) standard care (n = 100), consisting of~     6 weekly sessions administered individually by a professional.~   "
91106|NCT01864707|"~     The main aim of this trial is to evaluate whether additional acupuncture or~     mindfulness-based stress reduction is more efficacious than usual care only to reduce~     fatigue in patients with multiple sclerosis.~   "
91107|NCT01864694|"~     The aim of this study is to compare a Web-based system and a computer telephone system to~     determine their effectiveness in improving diet behaviors compared to each other and a~     control group.~   "
91110|NCT01864655|"~     Alzheimer's disease is a devastating neurodegenerative disorder, for which there is~     currently no effective treatment to slow or halt progression. Beta amyloid peptide~     accumulates in the brains of those with Alzheimer's, and is thought to play a major role in~     triggering the dementia. The investigators recently characterized a molecular pathway by~     which ß-amyloid damages neurons, and showed that the protein termed Fyn kinase is crucial.~     Our data suggest that blocking Fyn will have a significant therapeutic benefit for~     Alzheimer's. Astra Zeneca has developed a blocker of Fyn and related kinases (AZD0530) for~     the treatment of cancer. Chronic AZD0530 administration is well tolerated in humans, and the~     investigators propose to test its potential as a novel Alzheimer's disease modifying~     therapy. This study will assess the safety and tolerability of AZD0530 in patients with~     Alzheimer's disease.~   "
91111|NCT01864642|"~     The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce~     intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma~     suspect patients.~   "
91112|NCT01864629|"~     The purpose of this study is to examine the effectiveness of focused family planning~     counseling on the uptake and continuation of highly effective contraceptive methods (defined~     as the intrauterine device, implant, and both male and female sterilization methods~     including vasectomy, tubal ligation and Essure) during the postpartum period in women who~     have recently experienced a preterm delivery.~      The investigators hypothesize that women with a recent preterm birth (PTB) will be more~     likely to initiate and continue using a highly effective method of contraception when~     provided with focused family planning counseling.~   "
91113|NCT01864616|"~     The purpose for this study is to determine the effect of vitamin D supplementation on~     disease activity in Crohn's disease patients in Canada and Saudi Arabia~   "
91114|NCT01864603|"~     The SEARCH study aims to test evidenced-based innovative community based interventions that~     lead to the elimination of HIV in rural communities in East Africa using a multi-disease~     approach. The first phase of the study will quantify the health, economic and educational~     impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral~     therapy). This first phase will be completed in July 2017. The second phase of the study,~     will quantify the health, economic and educational impact of targeted Pre-Exposure~     Prophylaxis (PrEP), targeted HIV testing and targeted care interventions in the context of~     universal treatment and streamlined care. This second phase will be completed in July 2020.~     The study intervention is designed to improve the entire continuum of care, to reduce~     structural barriers for all populations including those most at risk.~   "
91115|NCT01864590|"~     The open abdomen is a valid and accepted surgical tactic for the trauma and acute care~     patient. There have been many mechanisms described for its management, but the most accepted~     strategy is the vacuum pack. At our hospital the investigators have used for many years a~     double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial~     operation. At subsequent surgeries once the abdomen is clean the investigators leave the~     same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the~     investigators try to tighten the mesh with sutures until the abdomen can be closed. This~     study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to~     determine which is related to a higher fascial closure rate.~   "
91116|NCT01864577|"~     The purpose of this study is to determine whether the use of negative pleural suction in~     tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax~     and/or hemothorax in patients with chest trauma.~   "
91117|NCT01864564|"~     Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese~     women (body mass index ≥30.0) will result in improved perinatal outcomes.~      Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18~     weeks will result in improved detection of GDM and reduce the need for third-trimester~     testing.~      Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of~     hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese~     population.~   "
91118|NCT01864551|"~     The investigators hypothesized that olanzapine will be superior to lamotrigine in the~     prevention of any kind of recurrence of bipolar disorder. On the other hand, lamotrigine~     group will have better prevention of depressive episode than olanzapine group. Meanwhile,~     the investigators supposed that there will be more concomitant medicine in lamictal group~     than olanzapine group. The comorbidity will influence the measurement of outcome such as~     time period of recurrence of depressive episode in both groups..~   "
91119|NCT01864538|"~     The primary objective of this study is to determine the response rate, duration of~     response,progression-free survival and overall survival of subjects with advanced melanoma~     treated with TH-302.~   "
91120|NCT01864525|"~     Essential voice tremor is a neurological condition that produces a regular, shaking quality~     in the voice. One form of drug treatment that produces some improvement in tremor of the~     hands is octanoic acid, which is a food additive that is similar to alcohol. Research~     suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no~     intoxication effects. This study will determine whether octanoic acid may be useful for~     reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid~     will reduce the effects of tremor on the voice.~   "
91121|NCT01864512|"~     This project was undertaken by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to report the alteration of Different Immune Parameters in ITP~     Patients Receiving Eltrombopag Treatment.~   "
91139|NCT01864278|"~     The registry will enroll patients with claudication or ischemic rest pain and an~     angiographically significant lesion in the superficial femoral or popliteal artery. Subjects~     will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark~     per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.~   "
91175|NCT01863810|"~     Diabetic neuropathy is known to be the most common complication of diabetes, although the~     estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is~     accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life~     and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to~     manage the chronic neuropathic pain in diabetic patients. This study is designed as a~     randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction~     measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th~     week of intervention is inferior to that of Lyrica.~   "
91122|NCT01864499|"~     Neurosurgery for supratentorial brain tumor is frequently associated with preoperative~     intracranial hypertension. The evaluation of intracranial pressure is available~     noninvasively by measuring the diameter of the optic nerve sheath ultrasound.~      The evaluation of intracranial pressure by measuring the DNO in perioperative is not~     described in the literature. The investigators propose a pilot study to assess intracranial~     pressure perioperative surgery for supratentorial brain tumor. The investigators consider a~     diameter of the optic nerve sheath as normal and predictive of intracranial pressure below~     20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the~     normal healthy adult unanesthetized is 5 mm.~      The main objective of the study is to compare the mean change in diameter of the optic nerve~     between the postoperative and D2 between groups of patients undergoing resection of a brain~     tumor and patients undergoing biopsy brain tumor.~      Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients~     is estimated according to the recruiting capabilities of neurosurgery for this type of~     patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control~     group: 20 patients Biopsy Brain Tumor.~   "
91123|NCT01864486|"~     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System~     (IRIS V1)~   "
91124|NCT01864473|"~     Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an~     ancient surgical problem. It was commonly described even in the Vedic period. The~     description of Bhagandara, with the full text of its managements, can be gathered from the~     Sushruta Samhita, which is supposed to have been written in the second century B.C.~     Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found~     anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal~     region, vagina etc.~      Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment~     due to probability of recurrence after surgery. The present treatment modality Kshar Sutra~     has been found effective and as adjuvant therapy by avoiding recurrence.~   "
91125|NCT01864460|"~     Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired~     glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting~     glucose (IFG), and early diabetes affects a considerably larger but unknown population~     group. At the current time there is no effective therapy to completely prevent, or reverse~     neuropathy associated with IGR and this represents a considerable challenge in~     rehabilitation. There is a particularly strong incentive to prevent IGT and related~     complications from advancing to DM2. IGR is a growing problem among all older adults and its~     strong association with many functional limitations, particularly mobility limitations, is~     not always recognized, even though diabetes-related disability occurs in up to 2/3 of older~     adults with diabetes and is associated with dependency, poor quality of life, and increased~     acute and long-term care utilization.~      Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data~     shows that over 90% of subjects with IGT have an abnormal score on questionnaires about~     autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet~     that are colder than the rest of the body, decreased sweating in the feet or increased~     sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation,~     or leaking of urine. In addition, patients with IGR have impaired balance control. These~     factors can increase the risk of falls in affected subjects. A non-randomized and~     non-controlled study showed that a diet and exercise intervention in patients with diabetes~     led to an overall improvement in autonomic function. Furthermore, it was shown that standing~     balance can be improved with a balance intervention program.~      However, there are no published studies that assess the effect of an intense physical~     activity intervention on autonomic function in IGR related neuropathy. This study will test~     an aerobic exercise and balance intervention in participants with IGR. The investigators~     will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and~     Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when~     compared to patients who receive standard care. Improving balance control and autonomic~     function can decrease the risk of falls and have a significant effect on the health of~     participants.~      The research is also significant because it will test subjects either before they become~     diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the~     autonomic neuropathy or balance impairment. Furthermore, the study is designed to test~     whether improvement in autonomic function and balance is associated with improvement in~     clinical outcomes, quality of life, and the metabolic state of participants. Thus, the~     proposed interventions are likely to have a real life impact on participants and their~     health.~   "
91126|NCT01864447|"~     Patients after an acute blood clot in the veins are at risk for leg-related complications~     such as pain, swelling, and immobility. In addition, the occurrence of blood clots can have~     major implications for personal health including weight gain, blood clot recurrence and~     impairment in cardiovascular functioning. The goal of this study is to determine whether~     aerobic exercise training is a therapeutic strategy to offset risk factors for recurrent~     blood clots or leg complications.~   "
91127|NCT01864434|"~     This study will compare the kinematics data collected from patients with implants created by~     different manufacturers to see which of these implants provides a more normal-like kinematic~     pattern compared to the normal knee.~   "
91128|NCT01864421|"~     This is an observational study to see if at birth, flow of blood from a placenta to the baby~     can be estimated non-invasively using Doppler ultrasound and/or cutaneous perfusion measured~     using a novel PPG sensor.~   "
91129|NCT01864408|"~     The primary aim is to assess whether an interactive patient/provider counseling process~     using a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of~     her bulge symptoms.~      The secondary aims are to assess whether an interactive patient/provider counseling process~     using web-based tool (iPadTM) will:~        1. Decrease patient anxiety with counseling~        2. Improve patient satisfaction with counseling~        3. Improve provider knowledge, anxiety, and satisfaction with counseling~        4. Be easy to use in clinic~        5. Be actually used in clinic~   "
91130|NCT01864395|"~     It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass~     will result in improved patient outcomes over the 12-hour post-operative period as compared~     to control and off-line MUFF.~   "
91140|NCT01864265|"~     By using functional MRI the investigators have recently shown that TNFi elicit rapid changes~     in brain function linked to the perception of RA [5]. Functional MRI represents a method~     allowing detecting tiny changes in neuronal activity by measuring alterations of blood flow~     in the context of neuronal activation. TNFi rapidly reversed the widespread activation of~     brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well~     as those involved in the control, of mood and emotions such as the limbic system. Moreover,~     as small phase I study with 10 patients with RA showed that high brain activity detected in~     the functional MRI predicts clinical response to Certolizumab Pegol after 1 month,~     suggesting the central nervous system activity may be used as a tool to predict response to~     TNFi [8]. The rationale of this study is to test whether response to TNFi can be predicted~     by using functional MRI.~   "
91141|NCT01864252|"~     The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury~     to the heart during heart-lung bypass surgery in combination with the newer technique of~     remote ischaemic preconditioning (RIPC).~   "
91391|NCT01860976|"~     The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment~     of psoriatic arthritis~   "
91131|NCT01864382|"~     The stroke as cerebrovascular disease is the leading cause of permanent neurological~     disability and the third death in the Western world. Their affected often have motor and~     sensory disturbances in the form of hemiparesis with a possible influence on the balance be~     altered trunk muscles, important components of postural control. The treatment of stroke,~     covers a wide range of different strategies and approaches physiotherapy, including,~     specific exercises on the trunk called core stability, performed by the patient with the~     help and supervision of a physiotherapist specializing in neurology, that are based on~     coordination, motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness~     of these last years has been demonstrated empirically, but until now there is no sufficient~     evidence of the effects of these exercises on sitting balance in respect, and standing up in~     the subacute phase post-stroke patients. To prove the evidence raises a randomized,~     multicenter, blinded and where the evaluator will not participate in the analysis and~     processing is done by intention to treat. Patients will be divided into two groups: control~     (usual physiotherapy center made ) and experimental (made also 15 minutes workout core~     stability). The intervention will have a frequency of 5 days a week for 5 weeks and up to~     12 weeks. The expected effect is that the experimental group patients develop better~     postural control at the trunk and this influences the balance in sitting, standing and~     walking.~   "
91132|NCT01864369|"~     Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital~     re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is~     50%. Counseling by multidisciplinary health care teams helps CHF patients to improve~     self-care behaviors (for medications, diet, exercise, smoking cessation and symptom~     monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of~     intervention, patient adherence to these behaviors is below recommended standards and~     quality of life among CHF patients becomes progressively compromised. A major challenge is~     to make self-care counseling available without overtaxing health care resources.~      This 3.5 year multicenter clinical trial will establish and evaluate a Canadian e-platform~     that provides multidisciplinary e-counseling to help patients with CHF to initiate and~     maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in~     Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of~     e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life,~     self-care behaviors and heart health. This proposal is based upon previous clinical trials~     in CHF, e-health and preventive lifestyle counseling by our team. It also builds upon our~     established collaboration with the consumer eHealth program of the Heart and Stroke~     Foundation of Ontario. The novel contribution of this research is that it will establish an~     infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key~     feature of this proposal is that our multidisciplinary team will work with the Heart and~     Stroke Foundation to share our findings and e-health resources with the public and other~     health care professionals in Canada, which will help to galvanize research and clinical work~     in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve~     the quality of life of patients with CHF.~   "
91133|NCT01864356|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple~     doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with~     a history of repeated IVF failures.~   "
91134|NCT01864343|"~     The primary goal in the treatment of acute myocardial infarction is to reperfuse the~     ischemic myocardium to reduce infarct size. Animal data and human data suggest that~     whole-body cooling to temperatures below 35°C before revascularisation can additionally~     reduce infarct size and therefore improves outcome in these patients.~      The purpose of the study is to determine the feasibility and safety of a combined cooling~     strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in~     patients with acute st-elevation myocardial infarction.~   "
91135|NCT01864330|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, information about the corneal residence time of topical lubricants is~     still sparse, therefore no ideal treatment regimen has been found.~      Recently a new method for assessment of tear film thickness based on optical coherence~     tomography (OCT) has become available. The aim of the present study is to assess corneal~     residence time of three different formulations of topical lubricants, in particular Thealoz~     Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye~     disease. In addition, standard tests for dry eye syndrome, such as the ocular surface~     disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be~     performed..~   "
91136|NCT01864317|"~     Glaucoma is among the leading causes for blindness in the western world. Elevated~     intraocular pressure (IOP) has been identified as the most important risk factor. However,~     some patients progress despite adequate IOP lowering while some subjects with elevated IOP~     never develop glaucoma. Other patients develop glaucoma although IOP measurements were~     always in the normal range. Therefore, other factors must be involved. In the last years,~     studies using MRI have been performed and evidence has accumulated that also changes in~     retrobulbar structures are present, in particular in the lateral geniculate nucleus and the~     visual cortex. However, these studies were limited by the low spatial resolution of the MRI~     instruments used.~      The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T~     whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at~     the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and~     the SC72 high-performance gradient system and is thus perfectly suited for structural and~     functional imaging. The aim of the present study is to investigate whether structural and~     functional parameters are altered in patients with primary open angle glaucoma (POAG),~     normal tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control~     subjects. The exact topographical survey of intracranial structures such as the LGN and the~     assessment of neuronal structures by DTI may allow for the better assessment of therapeutic~     responses to new neuroprotective agents.~   "
91137|NCT01864304|"~     Williams Syndrome (WS) is a genetic syndrome with features that may include vascular~     stenoses, neuro-developmental changes, and a variety of endocrine and metabolic~     abnormalities, including impaired glucose metabolism and abnormal body composition.~     Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral~     glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data~     suggest increased overall body fat in these individuals, as well as a relative increase in~     fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain~     incompletely characterized. The purpose of the current study is to carefully describe~     glucose metabolism and lipid parameters in people with WS.~   "
91138|NCT01864291|"~     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)~     can improve hearing in children who are deaf and cannot receive a cochlear implants.~   "
91142|NCT01864239|"~     The purpose of this study is to find out whether talking to a pharmacist on the telephone~     can help to support people taking medicine for a long-term condition.~   "
91145|NCT01864200|"~     This study will evaluate the recovery from copperhead snake bite in patients with mild or~     moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The~     trial is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in~     regions where copperhead bites are common. After blinded treatment and discharge, the~     subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake~     bite. The subject will also be called by telephone for follow-up assessments on day 10, 17,~     and 24 after snake bite. The purpose of this study is to compare recovery in copperhead~     snake bite patients treated with antivenom versus placebo (no active drug) as measured by~     the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.~   "
91146|NCT01864187|"~     Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective,~     potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects.~     The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of~     the drug in these people is still unknown.This research was designed to study the~     pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.~   "
91147|NCT01864174|"~     The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2~     diabetes is non-inferior to Metformin IR monotherapy~   "
91148|NCT01864161|"~     Anemia is a common complication in patients with chronic kidney disease (CKD). In addition~     to erythropoietin deficiency, many studies have identified iron deficiency as a cause of~     anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate~     intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant~     proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the~     prescription of iron is usually oral because of practicality and safety, but often it is~     inevitable to administer intravenous iron because of gastroenteric malabsorption,~     intolerance to oral administration, irregular intake. There're few randomized controlled~     studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis;~     most of them demonstrate superiority of intravenous therapy to restore iron deficiency and~     hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric~     absorption and high bioavailability with lower incidence of side effects. The investigators~     study aims to evaluate the efficacy of treatment with liposomal oral iron compared to~     intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.~   "
91149|NCT01864148|"~     The primary objective of the study is to evaluate the efficacy of BIIB033 in participants~     with active relapsing MS when used concurrently with Avonex.~      Secondary objectives of this study in this study population are to assess the safety,~     tolerability, and population PK of BIIB033 when used concurrently with Avonex~   "
91150|NCT01864135|"~     Prostate cancer has been the most common cancer in men in Finland over the last ten years.~     Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer.~     However, PSA has a limited sensitivity and specificity for prostate cancer detection.~     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)~     guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed~     instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications,~     there is an increasing interest in developing more accurate non-invasive imaging modalities.~      This study will enroll 150 men with clinical suspicion of prostate cancer due to higher~     serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination.~     Multiparametric magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using~     surface coils will be used to non-invasively predict the presence or absence of prostate~     cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to~     routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as~     biomarkers extracted from fresh biopsy sample will be collected and correlated with the~     presence or absence of prostate cancer.~   "
91151|NCT01864122|"~     The overall objective of this research proposal is to determine whether the predictive value~     of using plasma concentrations of selected nutrient biomarkers of food intake determined~     using a single plasma sample either alone or in combination are stronger, objective~     predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI)~     compared to selected food intake data derived from subjective, self-reported food frequency~     questionnaires.~   "
91152|NCT01864109|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     irinotecan and temozolomide has on Ewing sarcoma.~      Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat~     pediatric patients at MSKCC. The investigators have used these two drugs for many years to~     treat patients with Ewing sarcoma whose cancer has relapsed.~      For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a~     five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This~     standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have~     their cancer cured by the chemotherapy and surgery/radiation therapy.~      This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard~     EFT regimen. The investigators are trying to improve the success of standard therapy by~     adding these drugs. The use of irinotecan and temozolomide in this study is experimental~     because they have not been used before in patients with newly diagnosed Ewing sarcoma.~     However the investigators have found these drugs to be effective in patients with relapsed~     Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of~     patients treated for Ewing sarcoma.~   "
91153|NCT01864096|"~     This study aims to see if metformin can delay the time to progression in men with low risk~     prostate cancer when compared to a placebo.~   "
91154|NCT01864083|"~     This study has been designed to help us determine if FACBC PET or PEM can accurately~     evaluate how far the breast cancer has spread in the breast. Also, to help determine if~     FACBC PET or PEM can accurately measure your response to chemotherapy.~   "
91176|NCT01863797|"~     The purpose of the study was to compare early induction versus expectant management~     regarding outcome and experience of delivery in nulliparous women with a prolonged latent~     phase.~   "
91177|NCT01863784|"~     The purpose of this study is to characterize the pharmacokinetics (what the body does to the~     study medication) of JNJ-38518168 at approximately steady-state (stable medication levels)~     after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild~     or moderate hepatic (liver) impairment (abnormal function) compared with participants with~     normal hepatic function.~   "
91155|NCT01864070|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of everolimus with TheraSphere that can be given to patients with advanced NETs~     that have spread to the liver. The safety of everolimus and TheraSphere will also be~     studied.~      Everolimus is designed to block a protein inside the cancer cells, which is also involved in~     cancer growth.~      TheraSphere is a medical device containing a radioactive material called yttrium-90 (Y-90).~     Tiny glass beads called microspheres are filled with Y-90 and then injected through an~     artery directly into the liver. This allows a large dose of radiation to be given directly~     to the tumor, which may lower the risk of side effects from the radiation to other parts of~     the body and/or to healthy liver tissue. The radiation from TheraSphere stays in the body~     and begins to lose its effect within 12 days. The glass microspheres will stay in the body~     from that point on. The radiation will eventually decay (go away). By the time a participant~     leaves the hospital, the amount of radiation outside of the body will be low enough to not~     be a threat to others.~   "
91156|NCT01864057|"~     Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it~     appears to be a leading cause of infant death. The change in maternal and infant thiamine~     level after administration of thiamine to either Cambodian mothers or their infants is~     unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly~     characterized. The aim of this study is to determine if thiamine administered to nursing~     Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be~     obtained in nursing Caucasian mothers residing in the United States.~   "
91157|NCT01864044|"~     The aim of this observational study was to describe usual practices in lymphedema management~     in France.~      It was the opportunity to assess the effects of these practices on lymphedema volume in a~     large number of patients, to identify predictive factors of response, and to assess the~     safety of this therapy.~   "
91158|NCT01864031|"~     The association between alcohol consumption and cardiovascular disease (CVD) has mostly been~     examined using broad endpoints or cause-specific mortality. The purpose of our study is to~     compare the effect of alcohol consumption in the aetiology of a range of cardiovascular~     disease phenotypes.~   "
91159|NCT01864018|"~     This phase I/II trial studies the side effects and the best dose of cyclophosphamide when~     given together with ixazomib and dexamethasone in treating patients with previously~     untreated symptomatic multiple myeloma. Drugs used in chemotherapy, such as cyclophosphamide~     and dexamethasone, work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be a better~     treatment for multiple myeloma.~   "
91160|NCT01864005|"~     The purpose of this study is to test the hypothesis that the onset of the antiplatelet~     effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with~     ACS.~   "
91161|NCT01863992|"~     The investigators wish to learn about the quality of life (QOL) of children needing long~     term home ventilation and also that of their regular caregivers. In addition, the~     investigators will monitor the extra health-related expenses these families must meet. Data~     will be collected using two age-specific questionnaires of QOL plus a third one validated~     for assessing chronic health care costs. Questionnaires will be administered at an initial~     face to face meeting, supplemented by two telephone follow-up calls, to monitor medical~     expenses, one and two months later.~   "
91162|NCT01863979|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence~     increases with aging of the population. It is reflected in the ECG recording by the~     replacement of regular P-waves by an undulating baseline and irregular ventricular complexes~     [2]. The uncoordinated atrial activity prevents effective atrial contraction, leading to~     clot formation. Atrial fibrillation contributes significantly to population morbidity and~     mortality, and presently available therapeutic approaches have major limitations, including~     limited efficacy and potentially serious side effects. It can be classified into one of the~     three following categories:~        1. Paroxysmal: self-termination within 7 days~        2. Persistent: requires termination by pharmacological or direct-current electric~          cardioversion~        3. Permanent: restoration to sinus rhythm is impossible or inadvisable~      It is believed that in many cases the natural history of AF involves evolution from~     paroxysmal to persistent to permanent forms through the influence of atrial remodeling~     caused by the arrhythmia itself and/or progression of underlying heart disease. As many~     underlying conditions contribute to the development and progression of AF, the full and~     exact mechanisms standing behind this common arrhythmia are not completely or sufficiently~     understood.~      Thromboembolism is by far the most important complication of AF, and the most common factor~     in stroke in the elderly. The determinants of Virchow triad, including stasis, endothelial~     damage, and coagulation properties, are centrally involved in AF- related thrombus~     formation.~      Hence, thorough searching for new possible causes or contributing factors for the developing~     and progression of AF and its most threatening complication, thromboembolism, is mandatory~      The aim of the study is to look for new possible causes of atrial fibrillation and its~     complications.~   "
91163|NCT01863966|"~     From clinical observation that some achalasia patients drink water to help swallow food, the~     investigators have proposed a systemic hot water drinking therapy. This study is to observe~     its efficacy on achalasia symptoms and explore its mechanism.~   "
91164|NCT01863953|"~     This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine~     compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular~     hypertension.~   "
91178|NCT01863771|"~     The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese~     participants with moderately to severely active ulcerative colitis.~   "
91179|NCT01863758|"~     To compare the number of breakthrough bleeds under tailored prophylaxis with human cell line~     recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients~     who received Human-cl rhFVIII as on demand treatment.~   "
91180|NCT01863745|"~     The purpose of this study is to collect and assess long-term safety of nilotinib in patients~     who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are~     benefiting from the treatment as judged by the investigator.~   "
91181|NCT01863732|"~     This 3-year extension study aims at making available the treatment with secukinumab in~     prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III~     study CAIN457F2305, defined as core study, as well as to generate additional data on the~     sustainability of clinical benefits, safety and tolerability during long-term administration~     of secukinumab.~   "
91392|NCT01860963|"~     This study is designed to establish the prevalence of anal squamous intraepithelial lesion~     (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.~   "
91165|NCT01863940|"~     Ukraine is a newly sovereign country in Eastern Europe with a large burn population. With~     the collapse of the Soviet Union, burn programs have become decentralized and resources for~     maintaining facilities have dwindled. Patients frequently present with debilitating burn~     injuries and often do not receive necessary treatment secondary to limited resources and~     cost of treatment.~      The investigators have established an annual medical mission, outreach clinic and~     telemedicine relationship with hospitals and burn centers in Ukraine in an effort to improve~     burn care. One focus is post-operative pain control. The investigators have noticed a~     pattern of anxiety with children from the Ukraine surrounding dressing changes which they~     believe this is secondary to inadequate pain control in the immediate post-operative period~     including the initial dressing changes.~      The goal is to provide wound catheters with a continuous infusion of procaine in an attempt~     to reduce the pain experienced in the early post-operative period and specifically with~     dressing changes.~      There will be 200 participants, 12-65 years old who are receiving reconstructive plastic~     procedure with split-thickness skin grafts from lateral thigh in the study. 100 will receive~     the standard pain management Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM regimen and~     100 will receive wound catheters with continuous procaine infusion for 48 hours with the~     standard Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM available for breakthrough pain.~     Pain scores will be assessed prior to dressing change, during dressing changes and at 30~     minutes and 1 hour after dressing change.~   "
91166|NCT01863927|"~     The purpose of this preliminary experiment is to measure the effect of a novel ventilation~     system on the physiological strain during exercise in high heat load while wearing ballistic~     protective vest. Ten young and healthy participants will participate in the study. They will~     all go through a six days heat acclimation period in a heat chamber according to a valid~     protocol. Afterwards they will be randomly exposed to 4 conditions during four separate~     consecutive days.~   "
91167|NCT01863914|"~     Background Arteriovenous (AV) fistula is the most common vascular access for long-term~     hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are~     diabetes mellitus. However, the effects of hyperglycemia on the vascular function of~     arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the~     AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients~     also require a longer period of time for the maturation of AV fistula, and have slightly~     higher complication rate than non-diabetic patients. Statins have been widely shown to~     mediate several important pleiotropic effects in the improvement of vascular endothelial~     dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic~     plaques, inhibition of vascular smooth muscle proliferation, and modulation of procoagulant~     activity and platelet function.Our experimental studies in diabetic animals demonstrate that~     administration of a water-soluble statin rosuvastatin significantly improves the fistula~     flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression~     of vascular oxidative stress and inflammatory load.~      Study hypothesis The central hypothesis of this research project is rosuvastatin mediates~     pleiotropic protective effect on vascular endothelial function and suppresses the regional~     pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin~     during the perioperative period of creation of native AV fistulas in diabetic patients with~     ESRD may potentiate the vascular function and reduce the primary failure rate of AV~     fistulae.~   "
91168|NCT01863901|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment of~     upper limb spasticity using the Cryo-Touch III Device.~   "
91169|NCT01863888|"~     Primary Objective:~      To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing~     forms of multiple sclerosis as compared with baseline values and those of a reference~     population of untreated healthy subjects.~      Secondary Objectives:~      To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess~     the effect of Teriflunomide on the function of peripheral blood mononuclear cells~     (proliferation and cytokine production in situ).~      To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis~     (RMS) patients during a 24-week treatment versus baseline and healthy controls.~      To assess the reversibility of all parameter changes in patients who discontinue treatment~     after accelerated elimination procedure with cholestyramine or activated charcoal.~   "
91170|NCT01863875|"~     Treatment with cochlear implantation is now offered to proximately 95 % of children with~     deafness in Norway. More than 500 children have been operated at Oslo University Hospital.~     The study is a cross-sectional study aimed to investigate speech perception, language~     skills, quality of life in all childhood cochlear implant (CI) recipients in Norway from~     1988-2012. Factors such as child characteristics, characteristics with the family, the~     cochlear implant, the rehabilitation situation, choice of communication mode, school and~     work situation are surveyed to see if these factors can be associated with variations in~     outcome. The study will include pre and post lingual deaf children and children with~     multiple disabilities. Participants are recruited and examined in conjunction with their~     annual CI control at the hospital. It will be conducted a series of tests determining~     listening, speech and language development, non-verbal intelligence. Questionnaires are used~     to collect background information and quality of life experience. The questionnaires include~     self-report forms for different age groups, and a parent report form. The patient will be~     tested for the most common genetic causes of deafness. Additional data will be collected~     from patient records and from local health register at Oslo University Hospital.~   "
91171|NCT01863862|"~     In elderly patients postoperative mortality measured 3-6 months after total mesorectal~     excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly~     patients even if a risk of local recurrence is slightly higher compared to the open surgery.~     The investigators addressed the question whether watch and wait policy is safe in clinical~     complete responders after (chemo)radiation for elderly patients with small or moderately~     advanced tumours.~   "
91172|NCT01863849|"~     To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for~     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL~     of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination~     inhibition (HI) test.~   "
91173|NCT01863836|"~     The purpose of this study is to determine whether the use of fluoroscopy improves the~     diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial~     ultrasound (with the use of a guide sheath).~   "
91182|NCT01863719|"~     Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is~     administered intramuscularly, intravenously (IV) or via inhalation. In the case of~     pneumonia, aerosolized route of administration is favorable as it presumably delivers a high~     concentration of drug directly to the infection site. Colistimethate sodium is an FDA~     approved drug, however, its aerosolized use represents a new method of administration not~     currently FDA-approved in the United States. In this proposal, the inactive prodrug~     colistimethate sodium has been selected to use for aerosolization as it is better tolerated~     than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or~     IV formulations of colistin as multiple doses over seven days. The primary objective of this~     trial is to evaluate the safety and tolerability of multiple doses of aerosolized and~     intravenous colistimethate sodium separately or in combination in healthy adult subjects.~   "
91183|NCT01863706|"~     Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women.~     Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an~     alternative treatment when Oxytocin isn't available. The aim of this study is to compare the~     safety and efficacy of Oxytocin and misoprostol for prevention of PPH.~   "
91184|NCT01863693|"~     This multicenter, prospective, observational study will evaluate the safety and efficacy of~     Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients~     with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine~     clinical practice. Eligible patients will be followed for approximately 15 months.~   "
91185|NCT01863680|"~     The primary objective of this trial is to demonstrate the non-inferiority of the clinical~     pregnancy rate per embryo transfer to the historical standard value in in-vitro~     fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and~     Gynecology [JSOG] 2009 registry data: 24.3 percent [%]). The secondary objectives of this~     trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of~     COL-1620.~   "
91186|NCT01863667|"~     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the~     sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin~     intolerant or who have a contraindication to the use of metformin. The primary hypothesis is~     that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants~     treated with omarigliptin is non-inferior compared with that in participants treated with~     glimepiride.~   "
91187|NCT01863654|"~     The objective of this study was to confirm if two formulations of montelukast tablets are~     bioequivalent.~      Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product~     Singulair (5 mg chewable tablets; Merck Sharp & Dohme). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 32 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
91188|NCT01863641|"~     The purpose of this study is to determine whether calcitriol is effective in the treatment~     of lupus nephritis.~   "
91189|NCT01863628|"~     Background and study hypothesis:~      Many studies including prospective studies have been demonstrated that a long symptomatic~     prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12~     years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of~     syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention~     deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al.,~     2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood~     lability, increased energy, and psychomotor agitation are present most frequently. The~     prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia,~     feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid~     with pediatric ADHD. In addition, some symptoms are considered as non-specific such as~     decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).~      Offspring of parents with bipolar disorders are much likely to present prodromal symptoms~     compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal~     symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar~     disorder were considered as at risk compared to 17% in children of healthy parents. In a~     15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years~     old) of parents with bipolar disorder met the criteria of major mood episode.~      Objectives:~      One primary objective of this study is to prospectively identify the prodromal stage of~     bipolar disorder.~      Another primary objective is to conduct a randomized, place-controlled trial of aerobic~     exercise on people who suffering from prodromal symptoms to the extent of significantly~     impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar~     disorder.~      Design of study and the procedures:~      The study will consist of two phases: one-week screening period and a randomized,~     placebo-controlled, 3-month trial. During the screening period, offspring of parents with~     bipolar disorder will undergo systematically clinical evaluations. The offspring will be~     evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic~     resonance imaging. During the 3-month trial period, the offspring who meet the inclusion~     criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or~     wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the~     3-month trial.~      Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder~     aged between 10—25 years, meeting the inclusion of prodromal stage, will be included in the~     study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version~     (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well~     as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV~     (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I~     or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis~     I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be~     recruited through the referrals by their parents who will receive psychiatric services in~     the Guangzhou psychiatric Hospital.~      The offspring will be randomly assigned to aerobic exercise and placebo controlled groups.~     The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for~     40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to~     exercise to the extent of getting sweaty. In the placebo group, participants will receive~     general psychoeducation, including delivering knowledge on symptoms, discussion of the~     suffering mental difficulties, and general coping techniques.~      Significance:~      Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of~     prodromal stage of bipolar disorder and the early intervention on it may help delay or~     prevent the onset of bipolar disorder.~   "
91190|NCT01863615|"~     The objective of this study was to confirm if two formulations of isotretionin (capsules)~     are bioequivalent.~      Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product~     Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single~     dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fed conditions.~      The population was composed of 36 healthy volunteers, male adults between 18-45 years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
91191|NCT01863602|"~     The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of~     lamotrigine tablets to collect safety information in the long-term use according to seizure~     type and concomitant antiepileptic drug (AED), and to confirm its efficacy.~   "
91192|NCT01863589|"~     This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data~     among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir~     tablets.~   "
91193|NCT01863576|"~     The objective of this trial is to study the effects of omega-3 PUFA supplementation on the~     inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy.~      Study Type: Interventional~      Study Design: A total 40 patients will be randomly assigned into two parallel groups. The~     intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks, compared~     to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory~     markers (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Secondary endpoints~     will be the fasting glucose, lipid, and anthropometric profiles.~   "
91194|NCT01863563|"~     Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of~     QuickClot.~   "
91195|NCT01863550|"~     This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see~     how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating~     patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more~     cancer cells~   "
91196|NCT01863537|"~     This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and~     training package (Multimedia)and the other 40 to receive the original, manualized Connect~     intervention and training package (Traditional). The technology transfer process involves~     all agencies receiving four days of training and two planned technical assistance conference~     calls, by study investigative staff, in the first four months following training. Telephone~     assessments completed by up to 6 staff at each agency will measure primary outcomes,~     mediating, moderating and process measure variables at baseline, 6, 12 and 18 months~     post-technology transfer. The primary outcome of the study is adoptions of the Connect~     intervention. The unit of analysis is the CBO.~   "
91197|NCT01863524|"~     The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is~     1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and~     1% in women.~      As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients~     with acute coronary syndrome represent a high risk population in which screening for another~     atherosclerotic site is recommended.~      Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the~     opportunity to evaluate the cardiac morphology and function and to screen for Abdominal~     Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique~     was between 91-96% for AAA screening.~      In addition, this method is cheap, available and requires only 2-3 minutes to be added to~     the standard TTE.~      we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA~     by TTE in subcostal views in addition to the standard TTE examination.~   "
91198|NCT01863511|"~     For patients hospitalized with acute decompensated heart failure,volume removal remains the~     primary therapeutic objective. The current standard of care remains loop diuretics.The high~     likelihood of readmissions and poor outcomes highlights the need to examine and improve~     in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal,~     less neurohormonal stimulation and greater sodium removal.However it is associated with~     increased costs, line complications, and relative immobility during treatment. Tolvaptan in~     addition to diuretic therapy has been shown to improve the amount of volume removed compared~     to diuretic alone.~      The study proposes to compare the strategy of adding tolvaptan to usual care with~     ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.~      Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:~        -  greater volume and weight reduction compared with usual care~        -  similar efficacy outcomes compared with ultrafiltration, with less complications of~          therapy~   "
91199|NCT01863498|"~     Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000~     children. Operative repair of the anterior thoracic concavity has transitioned to the~     minimally invasive approach with substernal bar placement through small axillary incisions~     (Nuss procedure and multiple modifications). These procedures were quickly incorporated by~     high volume centers around the world including our own. The operation is certainly quicker~     and associated with less blood loss than the open operation, but as opposed to most~     minimally invasive versions of an operation, patients do not leave the hospital sooner after~     bar placement and experience more post-operative pain.~      Pain during the post-operative hospital stay is the dominant management issue after bar~     placement. The sparse literature on the topic has suggested that a thoracic epidural is the~     most effective means for attenuating the pain during the first few post-operative days.~     Therefore, most centers approach all patients undergoing a pectus deformity repair with an~     attempt at epidural placement under the assumption that this provides the most effective~     strategy for pain control.~      However, the investigators conducted a retrospective evaluation to examine the validity of~     this assumption and to investigate whether there is a role for a prospective study to~     determine the optimum post-operative pain management of these patients. The results~     demonstrate there was a decreased length of stay in the patients not treated with an~     epidural (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural~     was attempted, catheter placement failed.~      This data certainly challenges the assumption that an epidural is the optimum management for~     these patients, and convincingly answers the question as to whether there is a role for a~     prospective randomized trial.~   "
91200|NCT01863485|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.~   "
91201|NCT01863472|"~     Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the~     endoscopic ablation system in comparison to irrigated radiofrequency current ablation in~     patients with drug-refractory persistent atrial fibrillation.~   "
91202|NCT01863459|"~     1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of~          outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well~          as to evaluate the effects on quality of life .~        2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and~          depressive disorders which commonly occur with ADHD.~        3. To examine the potential relationship between telomere length and Adult ADHD with~          comorbidity and the potential effect of treatment response.~        4. To examine the potential associations with specific genes and Adult ADHD.~   "
91203|NCT01863446|"~     Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin~     secretion and reduce uterine contractions in women at late term pregnancies.~      Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported~     uterine contractions in women at late term pregnancies.~   "
91204|NCT01863433|"~     This is a study to assess the immune (antibody) response and safety of a bioCSL split~     virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira®~     vaccine in healthy adult volunteers aged between 18 and 60 years.~   "
91205|NCT01863420|"~     Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky~     or locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent~     therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous~     studies have founded acute HT was significantly associated the volume of pelvic (PBM) and~     lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing~     the volume of BM receiving low-dose RT might prevent HT.~      More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal,~     where is just in the low dose of RT in patients with gastric, rectal and cervical cancer.~     Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of~     PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is~     possible when the BM is entered as a separate constraint in the planning process. However,~     it is well known that hematopoietically active (red) BM is poorly visualized with computed~     tomography (CT). Consequently, the entire contents of the medullary canals must be entered~     as BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow)~     marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT~     thus overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An~     alternative approach is the incorporation of functional BM imaging into the treatment~     planning process. One economical and efficiency approach involves the use of T1-weighted~     magnetic resonance (MR) images.~      Therefore, we designed this study to test whether a separate constraint of active BM~     identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for~     patients with gastric and rectal cancer.~   "
91206|NCT01863407|"~     This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole~     (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal~     operation when compared with a placebo.~   "
91211|NCT01863342|"~     Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and~     synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central~     sensitization. The degenerative joint disease, osteoarthritis, with characteristic~     destruction of cartilage and alteration in bone is a very common cause of chronic pain. The~     degree of pain does not always correlate with the extent of joint damage or presence of~     active inflammation raising the possibility that there may be a central component to the~     pain. The central sensitization inventory (CSI) is a new self-report screening instrument to~     measure the degree of central sensitization, and to help identify patients with central~     sensitivity syndromes. The aim of this investigation is to evaluate the influence of~     preoperative central sensitization, which represented by CSI score, on postoperative pain~     score in osteoarthritis patients undergoing total knee replacement who receiving~     patient-controlled epidural analgesia.~   "
91212|NCT01863329|"~     Studies in patients with intracranial hypertension have shown a good relationship between~     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured~     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath~     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.~   "
91213|NCT01863316|"~     Although the safety and efficacy of the I gel in children has been shown in several large~     observational studies, There is no study about comparison of the clinical efficacy between~     I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme~     are new supraglottic airway device for children. It is made of a soft, gel-like elastomer~     with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been~     promising, showing an easy insertion, high airway leak pressures, and low complication rates~     with few postoperative complaints. The aim of this study is to compare clinical performance~     of the pediatric i-gel and LMA Supreme in infants.~   "
91214|NCT01863303|"~     The incidence risk of colorectal cancer （CRC） is increasing at 4.2% year by year in China.~     Most effective way to reduce the death rate of CRC patients is to diagnose in quite an early~     stage. QiaoKou District is a chemical industry Zone of Wuhan with a long history, which has~     few data of CRC epidemiology. The investigators design the primary CRC screening for this~     district by healthy questionnaire, Fecal Occult Blood Test(FOBT) and colonoscopy. HanYang~     Areo has been chosen as Control for its non-industry environment.The crowd would be screen~     biennially. The high risk group would be intervened, such as resection of polyps or other~     specific treatment. A follow-up registration database has been built for analysis the~     relationship between incidence or death rate to high risk factors, such as age, life~     environment, lifestyles, base diseases and family history of cancer.~      This study will provide some epidemiology dates of CRC to the local Government, and assist~     the governor to built a more effective screening system of CRC.~   "
91215|NCT01863290|"~     The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using~     trained, culturally competent primary care providers and community health workers (CHWs).~     The purpose of this project is to support ongoing quality improvement at the 13~     participating sites by training culturally competent CHWs and measuring the health, health~     care utilization, and the costs of caring for former inmates.~   "
91216|NCT01863277|"~     The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily)~     for a better clinical outcome in the period three days post stroke.~   "
91217|NCT01863264|"~     The purpose of this study is to see if cold liquids improve the swallowing mechanisms in~     premature infants with swallowing difficulties (dysphagia). The only way to objectively~     diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study~     (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants~     suspected of having dysphagia and who are referred for a VFSS will be recruited for this~     study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed~     with dysphagia, the study protocol will begin by keeping the infant the same position and~     feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be~     visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows~     and the study swallows will be recorded for analysis and comparison. It is hypothesized that~     the study swallows will have less deficits than the standard swallows. If an infant's~     standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this~     study.~   "
91218|NCT01863251|"~     To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4~     months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence~     (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV~     risk reduction counseling (EDRC).~   "
91219|NCT01863238|"~     This study is designed to evaluate the risk of cataracts (lens opacities) and describe the~     best corrected distance vision (with glasses/contacts for those who wear them) of pediatric~     patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor~     treatment initiation and are receiving or planning to receive commercially-available~     ivacaftor in the US.~   "
91220|NCT01863225|"~     This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and~     atorvastatin and rosuvastatin when either statin is administered in combination with~     RVX000222 in subjects with dyslipidemia.~   "
91221|NCT01863212|"~     In order to investigate if individuals, carrying genetic variants predisposing to obesity,~     respond differently to visual presented food images than non-carriers the investigators aim~     to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40~     subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be~     selected for the second step in the study. This part involves the fMRI technique to~     visualize the brain response, focus on reward system activation, when food images are~     visually presented in the scanner. Factors regarding eating behavior, sleep, physical~     exercise and relation to food are investigated in the first part of the study as well as~     clinical parameters such as BMI.~   "
91222|NCT01863199|"~     A study to use in home technology to reduce the burden of in office visits and injections.~   "
91393|NCT01860950|"~     The purpose of this study is to determine whether a new medical technology can temporarily~     alter pain perception. The new technology is called Transcranial direct current stimulation~     (tDCS).~   "
91223|NCT01863186|"~     The purpose of this study is to look at the efficacy and safety for lofexidine~     hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute~     withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient~     double-blind treatment portion where subjects will be randomly assigned to one of three~     doses of study medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of~     lofexidine, or placebo) followed by an optional open-label treatment period where subjects~     will be inpatient or outpatient and receive lofexidine at variable dosing for up to an~     additional 7 days. The Investigator hypothesizes that subjects will achieve maximum~     treatment effect with tolerable side effects at the 3.2 mg total daily dose and that both~     the 3.2 mg and 2.4 total daily doses will show better efficacy over placebo in treating~     symptoms of acute opioid withdrawal.~   "
91224|NCT01863173|"~     effect of B blocker was first evaluated in patient with cardiomyopathy not induced by~     ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on~     Thalassemia cardiomyopathy was evaluated in this study~   "
91225|NCT01863160|"~     It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to~     assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream,~     administered topically up to 5 consecutive treatment days in healthy volunteers.~      This is a single center trial. It is anticipated that the study will be conducted at the~     Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.~      The screening/enrollment visit includes a PK study for 24h following a single IP topical~     application. After a 24h washout time break, the subject will enter the treatment period for~     5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of~     treatment.~   "
91226|NCT01863147|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread~     in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong~     predictor of cardiovascular events and all-cause mortality .~      Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular~     mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .~   "
91227|NCT01863134|"~     1. INTRODUCTION~           Through last couple of years the number of patients treated for acute coronary event~          without persistent ST segment elevation in ECG has been growing.~           This is probably an effect of improving diagnostics of myocardial infraction without~          persistent ST segment elevation in ECG, due to routine Troponin serum level evaluation~          and better primary prevention.~           This fact makes the search for the optimal treatment for patients with acute coronary~          event without persistent ST segment elevation in ECG, including both patients intended~          for pharmacological and invasive treatment percutaneous coronary intervention (PCI) or~          coronary artery byppass grafting (CABG).~           Patients undergoing invasive treatment for acute coronary event, have higher risk rate,~          than those with stabile angina pectoris.~           The authors of this study want to evaluate, whether the proportional use of platelet GP~          IIb/IIIa receptor antagonist - eptifibatide in patients undergoing CABG results in~          improvement of short-, and long time results in those patients.~           Eptifibatide ( Integrilin) a cyclic heptapeptide antagonist of the GP IIb/IIIa integrin~          receptor, is an intravenous antagonist with rapid onset and short half-life.~        2. STUDY RATIONALE~      The notion acute coronary syndrome (ACS) includes several clinical situations, such a~     unstable coronary artery disease, non-Q wave myocardial infarction and Q wave myocardial~     infarction.~      On the basis of 12-lead ECG, patients with acute coronary syndrome (ACS) can be divided into~     two groups: with and without ST segment elevation.~      Another stratification factor in patients with ACS, especially these without ST elevation is~     evaluation of biochemical markers of myocardial necrosis, such as Troponins (TnI, TnT) and~     creatinine kinase isoenzymes (CK-MB). Serum concentrations of these markers allow to~     distinguish myocardial infarction (elevation of markers' concentration) from unstable~     coronary artery disease.~      All ACS have common etiopathogenesis which is plaque rupture, thrombus formation in the~     lumen of coronary artery.~      Platelets are the key factor in this process. Platelets by means of their collagen and von~     Willebrand factor glycoprotein receptors bind to damaged artery wall. Simultaneously many~     factors cause platelet activation, which leads to changes in their shape, release of~     intraplatelet components and activation of fibrinogen-binding glycoprotein receptors~     IIb/IIIa (GP IIb/IIIa). Activated form of GP IIb/IIIa binds to GP IIb/IIIa of another~     platelet by means of fibrinogen molecule. Fibrinogen molecules form stable bridges between~     platelets. This process is referred to as aggregation, and leads to clot formation, which is~     further stabilized by fibrine fibres.~      In this way the intravascular thrombus is formed, which after totally occluding the arterial~     lumen causes acute ischemia of the relevant region of myocardium and subsequently its~     infarction.~      The key role of GP IIa/IIIb in the process of platelet clot formation has important~     therapeutic consequences. By now several specific (direct) and non-specific (indirect)~     antagonists of GP IIb/IIIa have been developed.~      There are indirect antagonists as acetylsalicylic acid, ticlopidine and clopidogrel and~     direct antagonists as abciximab, tirofiban and eptifibatide Additionally also anticoagulants~     (heparin, LMWH - low molecular weight heparin) have antiplatelet properties by inhibiting~     thrombin production.~      Clinical studies performed all over the world have proven the efficacy and safety of three~     agents from the GP Iia/IIIb group: abciximab, tirofiban and eptifibatide.~      In several big clinical studies (EPIC, EPILOG, EPISTENT, ESPRIT, CAPTURE, PURSUIT,~     PRISM-PLUS, TACTICS-TIMI 18) the high efficacy of these drugs was showed in patients with~     ACS without ST segment elevation undergoing mainly percutaneous transluminal coronary~     angiography (PTCA) and stenting. The use of GP IIa/IIIb antagonists in this group of~     patients significantly reduces the death and myocardial infarction (MI) rate during early as~     well as late follow-up period. Moreover, last observations indicate, that the biggest~     benefit from such therapeutic strategy is observed in high risk patients; those with~     diabetes, high troponin levels and ECG changes.~      During last years, there is an increase in frequency of ACS without ST segment elevation.~     This is probably due to improved diagnostics of MI without ST elevation basing on routine~     troponin evaluation, but also thanks to better primary prevention.~      Therefore determining an optimal therapeutic strategy for patients with ACS without ST~     segment elevation remains a crucial issue.~      It concerns patients qualified to medical treatment as well as those qualified to invasive~     procedures (PTCA or CABG).~   "
91228|NCT01863121|"~     The CTP score is one of the best proved severity score in predicting mortality in patients~     with cirrhosis. Portal hypertension and variceal bleed are significant causes of morbidity~     and mortality in patients with cirrhosis. The recently published CTPK score included~     variceal variceal bleed status to the CTP score which improved the accuracy of CTP score in~     predicting short term mortality. CTPK score needs prospective validation.~   "
91229|NCT01863108|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in~     patients with melanoma. The secondary objectives are to determine immune response and~     clinical efficacy of such injections in patients with melanoma.~   "
91230|NCT01863095|"~     Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective~     interventions to help young adults (age 18 to 25 years) to reduce their MJ intake. In this~     study, we will develop and initially test a smart phone app designed to promote~     exercise/physical activity as a positive alternative to MJ use. The app will be tested in an~     efficacy study in which MJ users are randomly to either receive personalized feedback about~     MJ use + use the exercise app or personalized feedback only. The results will contribute to~     knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use~     and problems.~   "
91231|NCT01863082|"~     patients with resistant hypertension will be submitted to an exercise protocol in a heated~     pool for three months~   "
91232|NCT01863069|"~     The primary objective was to determine the tolerability of a new inhaled formulation of~     interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and~     compared with standard intramuscular (IM) AVONEX® when given as a single dose.~      The additional objectives were:~      To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon~     beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when~     given as a single dose, when given once per week for 4 weeks, and compared with standard IM~     AVONEX® when given as a single dose.~      To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon~     beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose,~     when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a~     single dose.~   "
91233|NCT01863056|"~     The purpose of this study was to determine whether the installation of sit-stand work~     stations could lead to decreased sedentary time and increased physical activity during the~     workday among sedentary office workers.~   "
91234|NCT01863043|"~     The primary purpose of this study is to determine nutrition outcomes and risks to~     gastrointestinal integrity and function of aspirating for routine gastric contents prior to~     each feeding in very low birth weight premature infants.~   "
91235|NCT01863030|"~     The objective of this study is to collect efficacy, safety and utility data with Phasix™~     Mesh in ventral and incisional repair procedures by evaluating the following:~        1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh~          for up to 12 months post surgery.~        2. Perioperative, short-term and long-term procedural and/or device related complications.~        3. Abdominal Wall Function and mobility.~   "
91236|NCT01863017|"~     The purpose of this study is to determine the effects of transcranial direct current~     stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and~     subjects with Prader-Willi syndrome (PWS).~   "
91264|NCT01862653|"~     Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops~     returning from combat zones. A majority of these veterans will report difficulty maintaining~     or initiating sleep. The purpose of this research will be to conduct a prospective,~     randomized, wait list controlled, small scale feasibility study to examine if the use of an~     auricular acupuncture regimen improves quality of sleep for Operation Iraqi~     Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD~     treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be~     improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard~     PTSD therapy or standard therapy alone.~   "
91237|NCT01863004|"~     Dysferlin is a protein with an important role in the repair of muscle surface membranes.~     Mutations in dysferlin cause different forms of muscular dystrophies. Dysferlinopathies are~     inherited in an autosomal recessive manner, and many patients with this disease harbor~     mis-sense mutations in at least one of their two pathogenic DYSF alleles. These patients~     have significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that~     dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control~     system. In a series of in-vitro experiments we showed that mis-sense mutated dysferlin can~     be salvaged from degradation by proteasomal inhibition. This resulted in an increase of~     functional dysferlin protein and a subsequent repair of plasma membranes of cultured~     patient-derived muscle cells. In this proof-of-concept study we would like to test wether~     proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain~     dysferlin mis-sense mutations.~   "
91238|NCT01862991|"~     This research study investigates the use of a drug, mifepristone, given before second~     trimester abortion. Mifepristone is a medication that is approved for medical abortion~     during the first trimester. It also has been used prior to abortion in the early seconds~     trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also~     called induction abortion). This medication has effects on the uterus that may help dilate,~     or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy.~     Cervical dilation, or opening, is essential to both ease of completion of procedure and~     reducing complications that can occur. These complications include laceration, or tearing,~     of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall~     of the uterus) and are not expected to be increased in the study. Dilation of the cervix is~     usually achieved by placing thin rods (cervical dilators) through the cervix. These rods~     then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard~     method of dilation is performed at the clinic and involves the placement of cervical~     dilators the day before the procedure. This procedure can be uncomfortable. A prior study~     showed that mifepristone reduces the number of osmotic dilators that need to be placed prior~     to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential~     adjunct to cervical dilation or used alone, without dilators, as method of cervical~     preparation with the hopes of reducing barriers imposed by painful procedures and time in~     clinic and away from work/home that the current approach involving dilators requires.~   "
91239|NCT01862978|"~     The goal of this study is to show the efficacy and safety of heparin and nadroparin in the~     acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2~     hours after onset of clinical signs. Overall administration of anticoagulant agents will~     test 72 hours.~      Randomized patients will be divided into three groups. The first group of patients will~     receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by~     intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT.~     After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic~     dose.~      Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose~     as recommended.~      The third group of patients are those who will receive placebo intravenously and 24 hours~     after receiving nadroparin subcutaneously in the therapeutic dose.~      All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.~      For initiation of treatment will be assessed:~        -  Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion~          criteria~        -  Sign the informed consent and patient randomization~        -  Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic~          coagulation~        -  Women of childbearing age (pregnancy test)~        -  History, clinical presentation, medical history, basic internal review of the status~          (blood pressure, pulse, body temperature, etc.).~        -  Initial CT examination of the brain~        -  EKG~        -  USG sections of extracranial carotid and vertebral arteries~        -  special hematology factors~      If a patient meets all the necessary criteria, he may be given the test substance. During~     the first 24 hours will be monitored at regular intervals vital functions.~      After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also~     100 mg of aspirin per orally.~      In the interval from 24 to 30 hours of starting treatment the patient will be made:~        -  Control CT brain~        -  EKG~        -  Basic coagulation~        -  Reduction to stop treatment for newly identified haemorrhage or severe and extensive~          focal cerebral ischemia by CT scan~        -  special hematology factors~           72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation~          using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel~          Index.~      Safety endpoints: mortality, adverse side effects, bleeding~   "
91240|NCT01862965|"~     In this study patients with moderate to severe chronic graft-versus-host disease will be~     treated with a combination of prednisone and everolimus. Patients will be treated on the~     study for a maximum of 12 months and followed up for another 12 months.~      The primary hypothesis of this study is that the addition of everolimus to prednisone~     increases response rates without increasing treatment related mortality or mortality due to~     relapse of underlying disease.~   "
91241|NCT01862952|"~     Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke~     epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal~     damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard~     to detect interictal, ictal and subclinical epileptic brain activity.~      Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack~     will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and~     paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed~     together with the EEG results. The EEG results will be correlated with the occurence of~     epileptic seizures and functional outcome and mortality in the acute phase and in the~     long-term. When subclinical epileptic discharges are found on the EEG, patients will be~     asked to participate in a second part of the study where they will be randomised into a~     treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months.~     Outcome parameters will be the occurrence of epileptic seizures, mortality and functional~     outcome.~      Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the~     acute phase following stroke influences functional outcome.~   "
91242|NCT01862939|"~     This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.~      Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized,~     placebo-controlled, two-period sequential pharmacodynamic (PD) arm.~   "
91265|NCT01862640|"~     To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in subjects with~     agitation associated with dementia of the Alzheimer's type.~   "
91266|NCT01862627|"~     Clinical features, optical coherence tomography findings and surgical outcome in eyes with~     macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit~     or high myopia were evaluated.~   "
91394|NCT01860937|"~     The purpose of this study is to test the safety of giving the patient special cells made~     from their own blood called Modified T-cells. The goal is to find a safe dose of modified~     T-cells for patients whose leukemia has returned to the bone marrow.~   "
94015|NCT01826526|"~     The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient~     than saline solution 0.9% as a catheter lock solution in preventing catheter related blood~     stream infections in patients with home parenteral nutrition.~   "
91243|NCT01862926|"~     Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung~     and is the leading cause of death in patients with systemic sclerosis, and contributes~     significantly to morbidity and mortality in many other connective tissue diseases (CTDs)~     such as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is~     extensive and/or progressive, immunosuppressive medication is often required to stabilize~     lung disease and alleviate symptoms. Current standard care for CTD associated ILD is~     extrapolated from studies performed in individuals with systemic sclerosis and comprises low~     dose corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some~     individuals even this intensive immunosuppression is insufficient to prevent deterioration,~     and in a significant minority of affected individuals this results in respiratory failure~     and death. Rituximab has recently been reported as an effective 'rescue therapy' for~     stabilizing and even improving ILD in this patient group. Based on observations gained from~     this experience, the investigators believe that rituximab is a potential important~     alternative to current best therapy for this patient group. This study has therefore been~     initiated to evaluate the efficacy of rituximab (compared with standard therapy) in patients~     with progressive CTD related ILD.~   "
91244|NCT01862913|"~     Background: Most adolescents suffering depression are treated in primary care clinics.~     Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The~     availability of appropriately trained CBT therapist may be limited, especially in primary~     care clinics. One way to increase the availability of CBT is to use computer-assisted CBT~     (c-CBT). It can be effective in the treatment of adults, although the outcomes in~     adolescents remain unclear.~      Purpose: The purpose of this study is to determine whether a computer-assisted~     cognitive-behavioral therapy is effective for the treatment of depression in adolescents~     between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.~      Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be~     carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the~     computerized-assisted cognitive behavioral therapy will be evaluated.~   "
91245|NCT01862900|"~     This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with~     stereotactic body radiation in breast cancer patients that have liver or lung metastases and~     have received systemic therapy and have progressive disease. The investigators hypothesize~     that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor~     immune system response. This amplified and directed immune response could result in~     anti-tumor responses.~   "
91246|NCT01862887|"~     The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24~     mg oral tablet on the QTc interval~   "
91247|NCT01862874|"~     A study to evaluate the efficacy, immunogenicity, and tolerability of V501 (quadrivalent~     Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine,~     GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501~     reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection~     compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or~     18-related persistent infection, condyloma acuminata, penile/perianal/perineal~     intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.~   "
91248|NCT01862861|"~     Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various~     menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced~     peri or post-menopausal women.~   "
91249|NCT01862848|"~     To evaluate the change in patient pain perception with the use of a topical compounded pain~     cream regimen.~   "
91250|NCT01862835|"~     Repletion of testosterone (T) in older men drives Growth Hormone secretion after its~     aromatization to estradiol (E2) by potentiating endogenous GH drive.~   "
91251|NCT01862822|"~     Urinary tract infection (UTI) is a frequently suspected cause of fever in young children,~     justifying urine cultures. Sampling procedures are decisive for the reliability of UTI~     diagnosis. Even though official guidelines recommend clean catch method, catheterization or~     suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate~     of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators~     have noticed that the rate of contaminated urine cultures was lower when children were kept~     in an upright position at the time of urine collection. The upright position could explain~     this decrease, perineum being less in contact with urine. These results are borderline~     significant, the investigators would like to confirm them with a specific study.~   "
91252|NCT01862809|"~     Background:~      - Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They~     contribute to human health in many ways, including digesting food and balancing hormones.~     Testing samples from the mouth can show how microbiotas are related to health and disease.~     However, the microbiota in a person's mouth differs depending on the methods of collection~     and the part of the mouth that is tested. Understanding what can change the microbiota~     (including mouth sites, and what a person eats or smokes) will give more information on how~     to study oral microbiota and smoking-related cancers and other diseases.~      Objectives:~        -  To see how smoking affects the microbiotas in mouth and nose.~        -  To determine which collection method for mouth specimens should be used for studying~          microbiota.~      Eligibility:~        -  Individuals at least 18 years of age who have been using tobacco products regularly for~          at least 5 years.~        -  Individuals at least 18 years of age who have never smoked.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a dental exam. They will provide a saliva sample. The dentist~          will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and~          teeth. The inside of the nose will also be swabbed.~        -  Participants will also fill out a questionnaire. It will ask about their history of~          smoking and consumption of alcohol, tea, and coffee. It will also ask about current~          medications, including antibiotics.~   "
91278|NCT01862458|"~     The objective of this study is to scientifically evaluate a new substrate for fibrinolysis~     compared to our standard tPA.~      The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the~     addition of DNAse.~      The primary outcome variable between the two techniques will be length of hospitalization~     after initiation of treatment.~   "
91253|NCT01862796|"~     Background:~      - Sticking to a diet plan can be difficult, but is important for many different health~     reasons. Some people seem to have a harder time following and sticking to a diet plan than~     others. It is not clear whether people of different weights (lean or obese) might have~     differences in the way they adhere to diet plans. Researchers want to study three different~     groups of people based on their body mass index (BMI), which measures people based on their~     weight and height. The study will place the participants on a 6-week diet and see how well~     they follow the diet. The information from this study may help develop better weight-loss~     plans and healthy diet ideas.~      Objectives:~        -  To understand what factors affect adherence to a diet plan.~        -  To collect information for future studies that may improve people's ability to stick to~          diets.~      Eligibility:~      - Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI~     greater than 30).~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will have a full-body scan to measure fat and muscle.~          They will also answer questions on eating behaviors, mood, and desire to change eating~          patterns.~        -  Participants will be separated into three groups. Each group will have a different~          diet. The lean group will have a heart-healthy diet designed to maintain the same~          weight. One of the obese groups will also have a heart-healthy diet designed to~          maintain the same weight. The other obese group will have a heart-healthy weight loss~          diet. In all groups, all food will be provided by the study doctors. Participants~          should not eat any food other than that provided for the study.~        -  Everyone will start with a 1-week food testing period to find the right number of~          calories for each group. After this first week, participants will attend one diet~          counseling session per week and will be contacted randomly once a week to check on the~          foods they have had in the past 24 hours. Participants will complete daily food diaries~          on paper as well as daily food records using a smart phone.~        -  Participants will come to the clinic twice a week to pick up the diet food. On one of~          those days, they will also have their counseling session.~        -  The study will last for 6 weeks. At the final study visit, participants will repeat the~          tests from the screening study.~   "
91254|NCT01862783|"~     Background:~      - Malaria is a disease caused by a parasite that infects the blood. It affects millions of~     people every year and frequently harms or kills pregnant woman and infants. Researchers are~     looking for treatments that may help pregnant women in areas of the world where malaria is~     common. To do so, they want to collect blood and other samples from pregnant women in~     south-central Uganda. They will also collect samples from newborn babies if the mother~     agrees to it.~      Objectives:~      - To collect biological material such as blood samples from pregnant women and newborns.~      Eligibility:~        -  Women between 14 and 45 years of age who are pregnant or are in labor.~        -  Participants will be from the Kalisizio area of south-central Uganda.~      Design:~        -  Women who are pregnant will provide blood and urine samples.~        -  Women who are in labor will allow researchers to collect samples from their baby after~          the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The~          baby will also be weighed and measured. Researchers will look at the baby's physical~          appearance and muscle strength.~        -  Treatment will not be offered as part of this study.~   "
91255|NCT01862770|"~     Background:~      - A health event can be a powerful motivator for abrupt behavior changes. For instance, many~     people who smoke stop after having a heart attack or being diagnosed with cancer. A relative~     s health event may have a similar effect. For instance, smokers may try to quit after~     learning that a parent or sibling has lung cancer. Researchers want to study relatives of~     people with lung cancer to see how the relative s diagnosis affects a person s willingness~     to quit smoking or have genetic testing.~      Objectives:~      - To study the impact of a relative s lung cancer diagnosis on a person s approach to~     genetic testing and smoking cessation services.~      Eligibility:~      - Current smokers between 18 and 55 years of age who are close blood relatives of people~     being treated for lung cancer.~      Design:~        -  Participants will be recruited through telephone surveys. Participants will log on to a~          password-protected website. The site has two educational sessions and three surveys to~          complete.~        -  Participants will also be offered free genetic testing. The test will see whether they~          have a gene that can reduce the effectiveness of some cancer treatment drugs. Those who~          agree to the test will collect a cheek swab sample at home and send the sample in for~          testing. They will receive the test results through the website.~        -  The surveys will ask about risk perceptions and emotional responses to the relative s~          diagnosis. They will also ask about smoking history, motivation to quit, and reactions~          to information about smoking and genetic risk.~        -  All participants will be able to receive free smoking cessation services.~        -  Six months after completing the surveys, participants will have a follow-up phone call.~          The call will ask whether participants used the smoking cessation services.~   "
91256|NCT01862757|"~     Background:~      - Some people who are obese may have decreased muscle strength. They may have greater muscle~     mass shown in scans, but they show poor results in exercise tests. Poor muscle strength~     might cause some of the difficulty with exercise performance. Researchers want to test~     muscle strength in the arms and legs of overweight women. They will also see how insulin~     resistance affects muscle strength in these women.~      Objectives:~        -  To test muscle strength in overweight women.~        -  To see if insulin resistance affects muscle strength.~      Eligibility:~      - Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2).~      Design:~        -  Participants will be asked to fast before having an initial blood test to measure~          glucose and insulin levels.~        -  On a different day, they will have the strength testing. The first test will measure~          leg muscle strength by testing the quadriceps and the hamstrings. The second test will~          measure arm muscle strength by testing the biceps and triceps. The final test will~          measure hand muscle (grip) strength.~        -  All the tests should take about an hour.~   "
91257|NCT01862744|"~     Background:~      - Parkinson's disease causes slow movements, stiffness, and tremor. It can get worse over~     time, and in some cases can lead to dementia. Researchers are interested in how dementia~     affects the brain in people with Parkinson's disease. They will study both people with~     Parkinson s disease and healthy volunteers. They will give tests of thinking and memory, and~     look at brain activity using imaging studies. This may provide more information on what~     parts of the brain are not working well in people who have dementia related to Parkinson's~     disease.~      Objectives:~      - To use imaging studies to see what parts of the brain do not work well in people with~     dementia caused by Parkinson's disease.~      Eligibility:~        -  Individuals at least 40 years of age who have Parkinson s disease.~        -  Healthy volunteers at least 40 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  This study requires two outpatient visits over 2 days.~        -  Participants will have tests of thinking, memory, and concentration. They will answer~          questions and fill out questionnaires. The tests will also look at how quickly they can~          move and handle small objects. The tests will take about 3 hours.~        -  Participants will have magnetic resonance imaging to study the brain. Functional MRI~          (fMRI) can show what parts of the brain are used when performing a task. Participants~          will respond to images on a computer screen during fMRI.~        -  Treatment will not be provided as part of this study.~   "
91279|NCT01862445|"~     This is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus~     Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic~     Lymphocytic Leukemia (B-CLL).~   "
91395|NCT01860924|"~     In this project the investigators will develop and pilot test a supervised, vigorous~     intensity exercise intervention for depressed female smokers. If the pilot intervention is~     successful the investigators will have a blueprint for a large randomized controlled trial.~     The long term objective is to develop interventions for depressed women that will ultimately~     reduce their risk of tobacco-caused disease and mortality.~   "
91258|NCT01862731|"~     Background:~      - Researchers are interested in how the muscles affect the movement of the knee cap. These~     muscles may be related to different kinds of knee pain that are not caused by an injury or a~     disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at~     these muscles. To study these muscles and how they move, researchers will use MRI to look at~     healthy individuals and individuals with knee cap pain.~      Objectives:~      - To study how changes to the muscles around the knee can influence knee pain.~      Eligibility:~        -  Individuals between 18 to 55 years of age who have knee cap pain that cannot be~          explained by a specific injury or disease.~        -  Healthy volunteers between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  This study requires two visits. Each visit will use standard MRI sequences to take~          images of the knee in motion and at rest.~        -  On the first visit, the MRI scan will look at the knee in its natural state.~          Participants will move the knee up and down for 1 to 3 minutes at a time during the~          scan.~        -  On the second visit, a local anesthetic agent will be injected into the muscle of the~          thigh. The anesthetic will block this muscle from generating force for 2 or 3 hours.~          Participants will move the knee up and down for 1 to 3 minutes at a time during the MRI~          scan.~   "
91259|NCT01862718|"~     Background:~      Pilot study to assess feasibility for combining treatment modalities that should be~     synergistic (radiation and thermal ablation).~      Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are~     standard treatments for focal neoplasms in the liver.~      High volume or scattered locations of tumor burden results in inability to successfully use~     this technology for a large proportion of patients with hepatic neoplasms.~      Methods to enhance treatment volumes could be advantageous in potentially increasing the~     indications for thermal ablation or the number of patients benefitting from local ablation.~      Primary objective:~      To determine the safety of combining 2 standard therapies (thermal ablation and external~     beam radiation therapy) for liver neoplasms up to 10 cm diameter.~      Eligibility:~      Patients greater than 18 years of age with pathologically proven unresectable primary or~     metastatic hepatic neoplasms~      Patients whose extent of hepatic metastases represents approximately less than 60% of total~     liver volume AND whose extrahepatic metastatic disease is determined to be minimal~      ECOG performance status of less than or equal to 2 and a life expectancy of more than 3~     months~      Patients with a history of chemotherapy, radiation therapy, or biological therapy for at~     least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must~     not have an acute, critical illness~      If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3~     mg/dl and Child-Pugh Classification A, (Class B & C are excluded)~      Design:~      Patients will undergo external beam radiation as well as thermal ablation according to~     standard operating procedures of the NCI and NIH CC.~      Patients will be monitored using the standard imaging studies when clinically warranted.~      Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is~     deemed beneficial for the patient by the investigator.~      The sample size will be 10 evaluable patients~   "
91260|NCT01862705|"~     Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in~     the management of patients with neck pain. However the mechanisms for pain relief associated~     with this intervention remain largely unexplained. Recent evidence suggests structures~     within the brain may have a role in creating responses of pain relief. This study aims to~     use functional magnetic resonance imaging (fMRI) to determine if there is a change in blood~     flow to structures within the brain following TSM in patients with neck pain. All patients~     will undergo fMRI while receiving painful stimuli directed to two separate sites, the~     cuticle of the index finger and the great toe. Subjects will then receive either TSM or~     sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful~     stimuli. The primary outcome of interest is the shift in blood flow within the brain before~     and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD)~     technology. This study will be the first to examine this type of response to manual therapy~     within the brain in patients with neck pain.~   "
91261|NCT01862692|"~     This innovative interactive Internet-based parent education intervention will help serve to~     promote the social emotional development and communication skills of infants to decrease the~     chances of child maltreatment in low-income, culturally diverse, families.~   "
91262|NCT01862679|"~     The most common forms of renal replacement therapy currently in use are high flux~     haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar~     to the patient, there are important differences in what happens to the blood as it travels~     through the dialysis machine.~      During HDF, the machine controls hydrostatic pressure across the dialyser to remove~     additional water together with toxins from the blood and this fluid volume is continually~     replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste~     substances, especially larger molecules, from the blood than HF-HD which may be of benefit~     to the patient in the medium to long term.Despite the theoretical advantages, trials have so~     far been unable to find any significant difference in death rates or the development of~     health problems among patients on HDF or HF-HD.~      It is therefore important to examine other factors which may help doctors and patients to~     decide which treatment to use. The investigators have designed a study which aims to answer~     three main questions:~        1. Does HDF make patients feel better?~        2. Is blood pressure more stable on HDF in comparison with HF-HD?~        3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?~      The investigators will do this by randomly assigning patients on HF-HD to receive 2 months~     of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without~     the patient knowing which treatment they are receiving. After two months the patients will~     switch to the alternative form of dialysis for a further two months. During the study the~     investigators will ask the patients how long it took them to recover from the preceding~     session of dialysis, assess the frequency of symptomatic low blood pressure and also perform~     blood tests at set intervals to measure specific blood parameters.~   "
91263|NCT01862666|"~     Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the~     normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its~     development is mostly associated with chronic injury from gastroesophageal reflux. BE is~     widely considered the leading risk factor for the development of esophageal adenocarcinoma~     (EAC).~      Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to~     ultrasound, however, instead of producing an image from the scattering of sound waves, it~     utilizes optical scattering based on differences in tissue composition to form a~     two-dimensional image. The benefit of VLE over ultrasound is that it is capable of~     generating cross-sectional images of tissues with an axial-resolution of up to 10~     micrometers, which is comparable to low-power microscopy.~      The proposed trial will evaluate the ability of physicians to use VLE to visualize high~     grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the~     ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic~     mucosal resection specimens as the gold standard.~   "
91326|NCT01861821|"~     The purpose of this study is to determine whether multiple ports improve the analgesic~     efficacy of flexible catheters used for the provision of epidural analgesia during the~     entire continuum of labor and delivery~   "
91327|NCT01861808|"~     The project is aimed to develop predictive indices of spinal cord injury severity through~     the analysis of cerebrospinal fluid of patient collected during acute injury.~   "
91418|NCT01860625|"~     Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch~     in healthy male subjects.~   "
91267|NCT01862614|"~     Infiltration (injecting next to the tooth) injections are common in dentistry and a number~     of studies have shown that articaine anesthetic, when injected next to a lower molar, is~     more effective than a local anesthetic injection of lidocaine. However success rates have~     not been as high as hoped for. No objective study has addressed the success rate of~     buffering articaine in a mandibular primary buccal infiltration of the first molar.~     Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to~     compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000~     epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution~     as a primary infiltration in the mandibular first molar. The investigators will also record~     the pain of injection and postoperative pain.~   "
91268|NCT01862601|"~     This research study is being done to see how well the JetTouch Needle-Free Endoscopic~     Injection System is able to deliver a solution safely into the bladder wall. The JetTouch~     Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected~     into the bladder without using a needle. It is hoped that this method will provide a~     reliable and consistent method to deliver drugs into the bladder wall.~   "
91269|NCT01862588|"~     Record the renal resistive index and hemodynamic parameters ( record the cardiac output and~     stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before~     and after resuscitation for severe sepsis or septic shock patients, to determine whether the~     changes of resistive index or hemodynamic parameters, especially the cardiac output can be a~     better parameter to predict AKI~   "
91270|NCT01862562|"~     Elderly patients have poorer preoperative conditions than younger patients. Therefore,~     minimally invasive surgery should be an effective treatment method for elderly patients. The~     investigators conducted a randomized trial that compared laparoscopic surgery and~     conventional open surgery in elderly patients who were 75 years old or over. The purpose of~     the present study was to clarify the effect of laparoscopic surgery in elderly patients. In~     our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery~     in short-term results, and same outcome in long -term results. Therefore, laparoscopic~     surgery would be recommended as standard procedure in an elderly colorectal patient.~   "
91271|NCT01862549|"~     This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy~     adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized~     to have lower drop-out rate, and higher treatment attendance and satisfaction. Further,~     DBT-C as compared to TAU will have significantly greater reduction in symptoms of Disruptive~     Mood Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable~     mood.~   "
91272|NCT01862536|"~     The functional, social, and economic burden of chronic obstructive lung disease (COPD) on~     the healthcare system is extraordinary. COPD is the fourth leading cause of death in the~     United States, and some estimates attribute up to $33.2 billion in health care costs to~     COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare~     system parallels these findings. According to the VA HSR&D Health Economics Resource Center,~     COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran~     patient population, is responsible for >14,000 VA hospital admission annually, and increases~     by $1,051/patient the total annual health care cost burden on the VA Healthcare system.~     Importantly, COPD is associated with frequent emergency room visitation and/or~     hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen~     morbidity and mortality in patients with COPD. This study will examine the potential for~     tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by~     decreasing pulmonary hypertension. Results from this study are expected to define the~     potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful,~     this treatment option may improve quality of life and outcomes for the large number of~     Veterans afflicted with PH due to COPD.~   "
91273|NCT01862523|"~     Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact~     mechanisms involved in this treatment. Therefore, this study aims to address this issue by~     studying the functional (electrophysiologic) changes after specific stimulations in IR~     patients and healthy controls before and after capsaicin/placebo treatment.~   "
91274|NCT01862510|"~     The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine~     to maintain a euthyroid state are at increased risk of having celiac disease. It also~     attempts to determine if there is a threshold level of levothyroxine needed to maintain a~     euthyroid state in patients with hypothyroidism that should prompt serologic testing for~     celiac disease.~   "
91275|NCT01862497|"~     The purpose of this study is 1) to determine what physiologic factors (extracellular fluid~     overload or vasoconstriction) contribute more to increased blood pressure levels between~     dialysis treatments in hemodialysis patients whose blood pressure increases and decreases~     during hemodialysis and 2) to determine whether carvedilol provides better control of blood~     pressure between dialysis treatments than prazosin in patients whose blood pressure~     increases during dialysis.~   "
91276|NCT01862484|"~     Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be~     placed on a restriction diet for a 5 week period. Children will be randomized to either~     receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a~     double blind fashion. It is hypothesized that children who are consistently on the~     restricted diet (relative to those on the ruse diet) will show improvements in ADHD~     symptoms.~   "
91277|NCT01862471|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES)~     have been shown to improve lower limb blood flow. However, few studies have directly~     compared the two methods and those that have, have used outdated NMES devices.~      The objective of this study is to compare the effectiveness of a modern NMES device to~     intermittent pneumatic compression in terms of blood flow.~   "
91328|NCT01861795|"~     The purpose of this observational study is to collect data on vital signs, oxygen~     requirements and other data related to ventilator care in preterm neonates under standard of~     care treatment.~   "
91280|NCT01862432|"~     At birth, the passage from intrauterine to the aerial life can be considered as one of the~     most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to~     provide numerous virtues and World Health Organisation (WHO) recently supported the~     introduction of such care among healthy, term-born neonates. Here, the investigators~     hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This~     randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section~     born neonates that received either immediate STSC with mother (intervention) or classical~     support and monitoring (control).~   "
91281|NCT01862419|"~     This study will randomize hospitalized patients with acute kidney injury (AKI) to usual~     care, or an electronic alert intervention. The electronic alert will be in the form of a~     text page that will be sent to the covering clinician and unit pharmacist once per patient~     with AKI at the time lab results are uploaded. The investigators hypothesize that such an~     alert will improve outcomes in these patients.~   "
91282|NCT01862406|"~     Although generic drugs are pharmacologically equivalent to their brand-name counterparts,~     prejudices against the former remain strong among patients and doctors. In a randomized~     controlled field experiment, this research assesses the extent to which generic (versus~     brand-name) labels affect patients' consumption dosage, medication compliance and reported~     pain.~   "
91283|NCT01862393|"~     This study aims to examine the variation in muscle torque and discomfort produced when~     electrically stimulating quadriceps femoris using pulsed current with three different phase~     durations in order to establish whether there are any advantages or disadvantages in varying~     the phase duration over the range examined.~   "
91284|NCT01862380|"~     The risk of adrenal insufficiency in patients with nonclassical congenital adrenal~     hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol~     replacement therapy in situation of acute stress or at long term is thus controversial. The~     mineralocorticoid reserve of these patients has never been evaluated.~      Hypothesis: The glucocorticoid and mineralocorticoid function of the adrenal glands in women~     with nonclassical 21-hydroxylase deficiency is comparable with the adrenal functions of~     healthy age- sexe- and BMI-matched subjects.~   "
91285|NCT01862367|"~     This study is conducted globally. The aim of this observational study is to investigate the~     incidence of specific adverse drug reactions associated with the use of recombinant factor~     XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital~     FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic~     events and lack of therapeutic effect.~      The study will aim at observing all patients exposed to NovoThirteen® in the EU, and~     additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered~     in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.~   "
91286|NCT01862354|"~     The purpose of this randomized controlled study is to compare the postoperative analgesic~     effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal~     plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction.~     Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of~     local anesthetics and clonidine are used.~   "
91287|NCT01862341|"~     In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics~     and other nutrients. This study will focus on the effects of fiber and probiotics on~     digestive health and health well being in selected Filipino mothers~   "
91288|NCT01862328|"~     This is an open-label, multicenter, phase 1b, dose escalation study of MLN4924 plus~     docetaxel, gemcitabine or combination of carboplatin and paclitaxel in adult patients with~     solid tumors.~   "
91289|NCT01862315|"~     The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to~     assess the effects this type of treatment has on the patient and the tumor. Liver pump~     treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy~     directly to the liver. Systemic chemotherapy gives chemotherapy through a vein~     [intravenously (IV)] and treats the whole body. This type of treatment has been done before~     and had shown that people with both pump and systemic chemotherapy had improved results. The~     investigators hope that this combination of treatments improves the response to chemotherapy~     and reduces the spread of the disease.~      Another purpose of this study is to learn the clinical importance of a specific type of MRI~     scan. The investigators would like to see if this type of MRI will help predict the response~     to the treatment and see if they could help the physician with their treatment plan. These~     scans will be done at specific time points.~      The last purpose of this study is to learn more about how the tumor interacts with the~     chemotherapy. This will be done through a biopsy taken during surgery and blood draws at~     specific time points.~      Permission from patients entering the study will be obtained to take normal and tumor liver~     biopsies at the time of surgery. These samples are voluntary and optional.~   "
91290|NCT01862302|"~     Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce~     the incidence, duration, and severity of post cardiotomy delirium?~   "
91291|NCT01862289|"~     Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment.~     Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to~     40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic~     hyperventilation syndrome in a specific population of difficult-to-treat asthmatics~     patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone~     with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain~     uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of~     the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood~     gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also~     will collect demographic information as well as information about asthma history, asthma~     control and treatment.~   "
91292|NCT01862276|"~     To investigate the prognosis due to presence or absence of bile duct resection in~     intrahepatic cholangiocarcinoma that require hepatic lobectomy.~   "
91293|NCT01862263|"~     The purpose of the study is to assess if the addition of vildagliptin as add-on therapy~     improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately~     controlled with insulin, with special emphasis in hypoglycemic episodes measured by~     continuous glucose monitoring.~   "
91294|NCT01862250|"~     This research is being done to find out the safety of the investigational study~     drug,clonidine, in infants who are undergoing whole body cooling for the treatment of~     hypoxic ischemic encephalopathy (HIE). HIE is the damage that occurs to the cells of the~     central nervous system (brain and spinal cord) as a result of decreased oxygen supply and~     blood flow to the fetus due to perinatal asphyxia (inadequate oxygen to the baby during the~     birth process). HIE is a significant cause of morbidity and mortality in infants. The only~     known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72~     hours. During the cooling process babies get agitated, shiver and are uncomfortable. To~     treat these side effects sedative-analgesic medications like morphine are frequently used.~     Clonidine (Clon), which is another class of sedative-analgesic can be used for the similar~     purpose but is more effective than morphine in decreasing shivering in adults and children.~     Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective~     (safe for the brain in models of brain injury). Clon (Duraclon®) has been approved by the~     Food and Drug Administration (FDA)for the treatment of pain in certain cancer patients. It~     is not approved for treating side effects of therapeutic hypothermia in infants and its use~     in this study is considered investigational. FDA is allowing for us to use clonidine for~     this Phase I-II study. In this kind of study clonidine will be started at low dose and~     slowly increased do determine at what dose the shivering is controlled and the use of~     clonidine is not associated with any side effects. This means that not all babies in the~     study will get the same dose of Clon. Doses at the beginning of the study will be lower than~     doses at the end of the study. Because of the design of the study, some babies may get doses~     that are too low to have an effect, and other babies will probably might get a doses that~     could cause side effects. In this Phase I-II study, the investigators will determine the (i)~     the maximum tolerated dose of clonidine during cooling for HIE, (ii) the effects of~     clonidine on heart rate, blood pressure, core body temperature and cerebral autoregulation~     (ability to maintain constant blood flow in the face of blood pressure changes) and (iii)~     association between blood levels and changes in the above parameters. In this study the~     investigators hope to find ways to improve sedation, shivering and agitation in newborn~     infants with HIE on the cooling protocol. Our ultimate goal is determine the potential~     neuro-protective properties of clonidine in newborn babies with HIE.~   "
91295|NCT01862237|"~     This project focuses on the physiopathology of left ventricular remodeling associated with~     type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve~     replacement.~      The main objective is to compare the reverse left ventricular remodeling between patients~     with type II diabetes and case-control patients without diabetes at one(1) year after~     surgical aortic valve replacement.~      The secondary objectives are :~        1. assess the influence of type II diabetes on left ventricular remodeling in patients~          presenting with aortic valve stenosis,~        2. assess the predictive value of myocardial fibrosis and other LV characteristics present~          prior to aortic valve surgery on the LV reverse remodeling and their influence on~          cardiovascular events at one (1) year after surgery,~        3. assess the influence of type II diabetes on cardiovascular morbidity and mortality post~          aortic valve surgery.~      The investigators main hypothesis is that patients with type II diabetes and aortic valve~     stenosis requiring aortic valve replacement have poorer LV function and less favorable post~     surgery clinical outcomes than patients without type II diabetes.~   "
91296|NCT01862224|"~     The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis~     (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with~     active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of~     JNJ-38518168 over one year.~   "
91297|NCT01862211|"~     The deficiency of alpha-1 antitrypsin (DA1AT) is a genetic disorder of variable clinical~     expression, initially described in adults with pulmonary emphysema patients. In children, it~     is the second cause of neonatal cholestasis after biliary atresia and is a common indication~     for liver transplantation.~      Several genotypes for SERPINA1 gene coding for alpha-1 anti-trypsin were identified. The~     main ones are M / M, M / Z, M / S and Z / Z and each genotype is closely correlated with the~     concentration of blood A1AT. The estimate for France suggests a prevalence of genotype~     deficit Z / Z of the order of 1/6054, (9982 patients), which in 11% of cases, have liver~     disease (prolonged neonatal jaundice). Half of them will move towards the development of~     cirrhosis with portal hypertension, at worst liver transplantation.~      Currently, we do not know what are the clinical and genetic factors that predispose a~     patient A1AT deficiency develop liver damage. Recent studies have led us to think that~     polymorphisms in the gene SERPINA1, as well as that of the alpha-mannosidase 1 endoplasmic~     reticulum (Erman gene) could be a predictive marker of liver complications. Another possible~     candidate gene is one of the importin beta (KPNB1), a protein involved in the elimination of~     misfolded proteins. These data lead us to propose the study of genetic polymorphisms.~      The main objective of the study is to compare the allele frequencies of these polymorphisms~     between (i) a cohort of A1AT deficient patients and with hepatic symptoms (portal~     hypertension and its complications, severe liver failure leading to transplant or not, or an~     indication for liver transplantation) and (ii) a cohort of A1AT deficient patients without~     signs of hepatic call. To build this last cohort, we will include in the genetic study the~     family members of deficient patients, some of whom probably carrying a deficit genotype Z /~     Z but without any associated clinical manifestations. This will allow us to facilitate the~     establishment of genotype profiles / phenotype clearly identified, which then allow a more~     appropriate care for children who may have such a development, we will strive to achieve a~     haplotype interpretation of polymorphisms found.~      This study will be conducted in association with the DEFI-ALPHA study to identify clinical~     and biological prognostic factors such as age at diagnosis, the diagnostic mode, the results~     of liver biopsy (when available), the clinical course, family history, the existence of IUGR~     and long-term treatment.~      The secondary objectives of the study are :~        -  The measurement and interpretation of serum IL-8 in A1AT-deficient patients. Indeed,~          one study showed a higher IL-8 in patients with ulcerative colitis compared with~          healthy patients' serum. These considerations led us to hypothesize that IL-8 may be a~          marker of liver disease in A1AT deficiency.~        -  Preservation of blood samples for further study of other genes, which may be in the~          future suspected to be associated with the occurrence of liver complications. To this~          end, a DNA bank will be created. It will involve the children with a deficiency of~          alpha-1 antitrypsin and their family of 1st and 2nd degree in civil law (parents and~          siblings).~      This study is a continuation of the cohort DEFI-ALPHA (descriptive study of a cohort of~     children with DA1AT) and sought to identify the clinical and biological factors such as age~     at diagnosis, diagnosis mode, the result sets of the liver biopsy (when available), clinical~     course, family history, the presence of IUGR and long-term treatment.~      The only criterion for not-inclusion is, according to the subject, the lack of consent of~     the child and his parents, the lack of consent of the adult patient, or the lack of consent~     of the witness. Demographic and clinical history data (for parents and brothers/sisters~     showing no DA1AT) will be collected.~      Currently, the cohort of patients with DA1AT is being set up in the framework of the Cohort~     DEFI-ALPHA. This multicenter project is realized with the help of french pediatric~     hepatology centers that regularly follow patients DA1AT. Today, over 100 patients DA1AT have~     already been identified, and the collection of historical data has already begun on several~     centers since September 2009. This study is therefore a continuation of this work.~      Over a period of 30 months, the total number of potentially includable subjects is estimated~     at about 400 in this study (100 patients and 300 related to the first degree such as~     parents, brothers and sisters).~      This study will be promoted by the Hospices Civils de Lyon. Authorization of the competent~     authority and the ethical committee will be obtained as well as informed consent from~     families before blood sampling.~   "
91298|NCT01862198|"~     The purpose of this study is to investigate the feasibility and safety of endoscopic~     ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.~   "
91299|NCT01862185|"~     Sepsis is a serious clinical condition with a considerable morbidity and mortality.~     Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The~     present study aimed to investigate the effect of semi-quantitative PCT test to the empirical~     antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in~     septic patients.~      The hypothesis of the study are :~        -  There is an effect on mortality between septic patients who do and do not do~          semi-quantitative PCT examination~        -  There is an effect on empirical antibiotic initiation time between septic patients who~          do and do not do semi-quantitative PCT examination~        -  There is an effect on appropriateness of empirical antibiotic between septic patients~          who do and do not do semi-quantitative PCT examination~      Study design is randomized diagnostic trial which is also a pragmatic trial.~   "
91300|NCT01862172|"~     Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy,~     localized in the ipsilateral primary motor area, measured in mm, three months after~     infarction of internal capsule.~      The patient is compared to himself between day zero to ten and three months.~      The study hypotheses are:~        -  A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral~          infarction of the internal capsule. It is measurable accurately and reproducibly by MRI~          at three months. Other brain areas within the voluntary motor system will also be~          explored (supplementary motor area, pre motor area).~        -  This atrophy is correlated with achievement of pyramidal tract, assessed by the~          fractional anisotropy of its fibers.~        -  This atrophy is correlated with disability at three months, assessed by Rankin score.~   "
91301|NCT01862159|"~     The rate of serious complications are relatively low in bariatric surgery today, but still~     3-4 % will suffer from a serious complication. There are factors known before the surgery or~     during the operation that are likely to increase the risk for a serious complication. If the~     investigators are aware of these we can optimize the patients risk factors prior to the~     operation or at least increase the awareness of the increased risk in some patients given~     the presence of risk factors.~   "
91302|NCT01862146|"~     Cigarette smoking is the most important modifiable cardiovascular risk factor leading to~     endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the~     study was to investigate the effect of smoking on vascular response to transradial coronary~     angiography (TCA).~   "
91303|NCT01862133|"~     Health information technology, including health information exchange, offers the potential~     to improve care by providing an integrated view of relevant, integrated patient information~     from multiple health care providers practicing in multiple sites. However, realizing that~     potential can be difficult, particularly with respect sensitive information. Increasingly,~     patients, patient advocate groups, and even the National Coordinator for Health Information~     Technology are pushing for patients to have more granular control over specifically who can~     see what personal health information in their electronic health records.~      This will be a demonstration project aimed at showing the initial feasibility a system~     allowing patient controls on their electronic health records. Because of the exploratory~     nature of the research, the investigators do not have specific hypotheses. The investigators~     hope that this demonstration and feasibility project will lead to more extensive prospective~     evaluations of patient control of access to their health records and other tools for~     enhancing patient control over access to their health records.~   "
91304|NCT01862120|"~     Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key~     role in the regulation of the immune system. At high doses, rhIL-2 activates the immune~     effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells~     (TREGS), a population of immune cells controlling the immune Teff response. In patients with~     Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of~     pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low~     dose is well tolerated in patients with an autoimmune disease and in adults with established~     T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low~     dose to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will~     investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to~     optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the~     investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune~     destruction, thus improving or even curing T1D.~   "
91305|NCT01862107|"~     Background:~      - Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases~     can only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test~     CSF. Once someone is already having a lumbar puncture, a small extra amount of CSF can be~     collected at the same time. This fluid can be used to study brain, nerve, and related health~     issues. Researchers want to collect CSF and blood samples from people who are scheduled to~     have a lumbar puncture.~      Objectives:~      - To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar~     puncture.~      Eligibility:~      - Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for~     clinical or research purposes.~      Design:~        -  Participants will have a lumbar puncture for clinical or research purposes.~        -  During the procedure, an additional sample of CSF will be collected. They will also~          provide a blood sample, if one is not taken at the time of the procedure.~        -  Treatment will not be provided as part of this study.~   "
91306|NCT01862081|"~     This is an open-label, multicenter, dose-escalation study designed to assess the safety,~     tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either~     docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have~     HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer~     (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal~     growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer.~     There are two potential stages within each arm of this study: a dose-escalation stage (Stage~     1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a~     given arm has been established from dose escalation, additional patients with each~     combination will be enrolled in Stage 2.~   "
91307|NCT01862068|"~     Anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis are rare diseases~     characterized by inflammation of blood vessels. Among the numerous cell types that play a~     role in vasculitis, one of the key actors is the neutrophil. Neutrophils are equipped with~     very powerful molecules that they use to destroy the invading microbes. Therefore, the~     mechanisms controlling neutrophil activation should be tightly controlled. If that is not~     the case, neutrophils may destroy the tissues of the host. This is what happens during~     chronic inflammation in vasculitis. Autoantibodies directed against neutrophils, ANCA,~     produced thus demonstrating that neutrophils are also targets of the immune system in these~     diseases. In addition, molecular studies provided evidence that genes normally silenced in~     mature neutrophils under normal conditions can be re-expressed in neutrophils from patients~     with ANCA-associated vasculitis thus strongly suggesting a profound deregulation of~     neutrophil functions in these conditions. Notably, the investigators have preliminary data~     showing that neutrophils from patients with granulomatosis with polyangiitis (GPA, formerly~     Wegener's granulomatosis), an ANCA-associated vasculitis, interfere with the normal phase of~     resolution of inflammation.~      The objective of the investigators' study is to understand the mechanisms underlying this~     increased activation state and determine if neutrophils could be used to define prognostic~     markers by clinicians to optimize patients' care. Therefore, the investigators plan to study~     the expression of proteins implicated in GPA pathophysiology at the membrane of neutrophils~     when they undergo apoptosis. The investigators will also study the deregulation of protein~     expression in neutrophils. This point will be the molecular translation of neutrophil~     deregulation. This technique is powerful and well adapted to identify by mass spectrometry~     the proteins that will be differentially expressed between the control and the disease~     state. After identification of proteins differentially expressed in patients with GPA, the~     investigators will further investigate whether their expression is modulated during the~     disease course and/or modified by the treatment.~      The investigators believe that understanding these neutrophil perturbations can lead to~     better monitoring of disease activity. Ultimately, the investigators may propose more~     targeted anti-inflammatory therapies which would be better tolerated by patients. the~     investigators also can identify new markers for disease activity which allow clinicians to~     define a better therapeutic strategy.~   "
91308|NCT01862055|"~     Spinal anesthesia is the technique of choice for planned cesarean section. It is associated~     with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system~     assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of~     maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by~     maternal stress that can be measured with salivary amylase. The goal of this study is to~     assess the relationship between salivary amylase and severity of maternal hypotension after~     spinal anesthesia for planned cesarean section.~   "
91309|NCT01862042|"~     The purpose of this study is to evaluate the quality of supportive and palliative care for~     SMA type 1 patients.~   "
91310|NCT01862029|"~     Background:~      - Roflumilast is a drug used to treat chronic obstructive pulmonary disease (COPD). It is~     designed to help reduce lung inflammation. However, during testing, roflumilast also~     appeared to reduce high blood sugar levels in people with COPD and type 2 diabetes. Other~     tests showed that roflumilast also improved blood sugar levels in people who only had type 2~     diabetes. Researchers want to see how roflumilast affects insulin and blood sugar levels in~     overweight or obese people who are not diabetic, but who have high blood sugar levels.~      Objectives:~      - To see how well roflumilast improves blood sugar and insulin levels in prediabetic~     overweight or obese individuals.~      Eligibility:~      - Individuals between 30 to 65 years old who are overweight or obese (body mass index of~     24.9 to 39.9 kg/m2) and have elevated blood sugar levels.~      Design:~        -  This study will last approximately 8 weeks. Participants will have approximately five~          study visits over about 7 weeks. Two of these visits will be overnight inpatient stays.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also have a 3-day diet and exercise assessment~          with a dietitian.~        -  In Week 1, participants will have a special diet for 2 days to keep their regular~          weight. They will then have a 2-day inpatient stay. During their stay, they will have~          multiple tests, including blood sugar tests and full body scans. They may provide a fat~          and muscle tissue biopsy sample. They will then receive the study drug to take during~          the study.~        -  In Week 2, participants will repeat the diet study from the screening visit. They will~          receive a different dose of the study drug.~        -  In Week 3, participants will review their diet results and have blood and urine tests.~        -  In Week 5, participants will repeat the diet and exercise study from the screening~          visit.~        -  In Week 6, participants will repeat the inpatient studies and tests from Week 1.~      In the last week, participants will have a final follow-up visit.~   "
91338|NCT01861665|"~     The purpose of this trial is to compare incisional pain in patients receiving pre-incisional~     versus post operative Marcaine injection.~   "
91419|NCT01860612|"~     The purpose of this study is to evaluate the safety and effectiveness of an artificial iris~     prosthesis for the treatment of iris defects.~   "
91845|NCT01855022|"~     The primary purpose of this study is to determine the effectiveness of a hospital-based~     intervention, using motivational interviewing and interactive voice response (IVR), to~     reduce hospital readmissions within 90 days of enrollment compared to usual care, for~     patients with heart failure and chronic obstructive pulmonary disease.~   "
91311|NCT01862016|"~     The care of acute respiratory distress syndrome (ARDS) has been significantly improved by~     learning from experimental and physiological research works and by a series of randomized~     controlled trials. The mortality of this syndrome remains however high. Numerous~     experimental and clinical works demonstrated that a ventilatory mode authorizing the patient~     to make, from the acute phase, spontaneous breathing cycles superimposed on assistance~     delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and~     hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This~     ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by~     ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a~     reduction of mortality in ARDS patients.~      The aim of this multicenter, prospective, randomized, controlled, open study is to compare~     the effects of two ventilatory strategies on the mortality of ARDS patients and placed under~     mechanical ventilation.~   "
91312|NCT01862003|"~     Recruitment to phase I of the PANTHER trial is complete.~      In phase II, the combination of AZD8931 and FOLFIRI will be compared to FOLFIRI alone, to~     determine the efficacy of the treatment.~   "
91313|NCT01861990|"~     The study investigates valproic acid added to radiation and temozolomide therapy (standard~     of care) for progressive or recurrent pediatric brain tumors.~   "
91314|NCT01861977|"~     The purpose of this study is to determine the effectiveness of a program to improve habits~     in a population with cardiovascular disease, comparing two different educational techniques~     (cognitive behavioral therapy group vs. informational workshops).~   "
91315|NCT01861964|"~     Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly~     efficacious prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d),~     which is much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or~     galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves~     diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may~     also reduce blood cholesterol and may improve glycemic control, although more data from~     clinical trials are needed to confirm preliminary findings.~   "
91316|NCT01861951|"~     Patients with a locally advanced or metastatic (i.e., there are already metastases of the~     diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be~     recruited for this study. The minimum age to enter the study is 60 years.~      Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients,~     which is associated with hematological toxicity and an increase of the infection rate.~     Pazopanib is known to rarely induce hematological toxicity or to trigger infection. We~     therefore assume that pazopanib exerts similar activity while decreasing neutropenia and~     neutropenic fever. Pazopanib is already approved in the U.S. and Europe for the treatment of~     advanced soft tissue sarcoma.~      Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or~     pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment~     effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the~     survival rate, and the duration of tumor control by the different therapies. A further~     objective is to measure the quality of life by standardized questionnaires throughout the~     course of treatment.~   "
91317|NCT01861938|"~     This study is based on the hypothesis that stimulation of the immune response against the~     tumor can help destroy residual tumor in melanoma patients with very high risk for disease~     recurrence and in patients with relatively low tumor burden who already got first line~     treatment for their disease.~      Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients~     with a cell line of tumor cells from the patient himself, or with a combination of three~     cell lines that partially match the patient's cell characteristics, could improve the immune~     response against the tumor, was associated with improved disease-free and overall survival.~      In this study, the investigators will evaluate the efficacy of a modified tumor cell~     vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine~     consists of a cell line that has a high expression level of melanoma molecules, and has been~     genetically modified to induce a strong immune response.~   "
91318|NCT01861925|"~     The purpose of this study is to quantify in-vivo repeatability of a new corneal topography~     measurement mode of an optical biometer, and the clinical performance of measurement in~     comparison to reference devices.~   "
91319|NCT01861912|"~     The purpose of this study is to determine whether compared with arsenic trioxide TACE alone,~     arsenic trioxide TACE and intravenous administration could further prolong the overall~     survival.~   "
91320|NCT01861899|"~     The objective of this study is to gather clinical data on SI-LOK® for the treatment of~     sacroiliac joint dysfunction.~      The purpose of this prospective study is to evaluate clinical and radiographic outcomes,~     intra-operative parameters, patient satisfaction and work status following a procedure using~     SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.~   "
91321|NCT01861886|"~     To evaluate the safety and long-term (approximately one year) effectiveness of the Essure~     System for Permanent Birth Control ESS505 device in preventing pregnancy.~   "
91322|NCT01861873|"~     Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment~     planning assumes homogenous distribution of function in the normal liver tissue. In~     functional treatment planning, additional information on distribution of the function~     derived from functional imaging of normal tissue is taken into account. by functional~     treatment planning it becomes possible to prioritize and spare the best functioning part of~     an organ.~      Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the~     best functioning liver tissue.~      Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan~     one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or~     higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring~     system that includes biochemical measures as well as symptomatic scores.~   "
91323|NCT01861860|"~     Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been~     specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization~     (AVIO) study was performed with (medical device's type )Promus stent, results are promising,~     but the study was not designed for clinical endpoint.~      There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely~     used in the early 2000, but have limitations for complex long lesions. The AVIO criteria~     were recently proposed for complex lesions, but these criteria also have some issues and the~     complexity make their routine use challenging.~      We performed a pilot study for long complex lesion analysis using IVUS, in order to define~     easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The~     new criteria (OPERA) are an adaptation of the MUSIC criteria.~      OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major~     Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the~     study.~      Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS~     element stent deployment?~      Study design This study will consist to prospectively include consecutive patients with>28mm~     taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives~     to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients~     from the OTELLO study, with the same inclusion criteria, will composed the control group .~     Population will be matched using the propensity score.~      20 to 30 French centers involved in OTELLO study will be contacted for participating in~     OPERA.~      Hypothesis:~      Long lesion percutaneous coronary intervention(PCI) have specific characteristics like~     Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter~     Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the~     balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA~     criteria have better outcomes than without IVUS~      Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial~     infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm~     implantation~      Secondary endpoint~        1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria~        2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI~        3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO~      Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non~     expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm~     implantation with IVUS and OPERA criteria~      Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric~     study propensity score matched analysis matched for comparison to OTELLO study. (Same~     inclusion criteria as OTELLO)~      Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected~     in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73~     Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts~     inclusions.~      Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts~      Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months~     telephone contact~      Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization~     (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery,~     According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours~   "
91324|NCT01861847|"~     The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing~     symptoms of Post-Traumatic Stress Disorder (PTSD).~   "
91325|NCT01861834|"~     To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based~     intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable~     oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver~     transplantation.~   "
91329|NCT01861782|"~     Prospective open label crossover self controlled study. The study population will randomly~     be divided into two groups.~      The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16~     participants and one of 14 participants) and will be comprised of 3 main stages:~        1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the~          two groups will have its own treatment protocol)~        2. 12-month washout period~        3. Crossover of the two groups and second exposure to treatment for 14 days excluding~          Friday and Saturday (each of the two groups will have its own treatment protocol).~      The population in the study will be composed of patients diagnosed and treated for~     rheumatoid arthritis at the Soroka University Medical Center who are 18 and above of age.~      The patients will be selected by the PI and his team and addressed regarding their~     willingness to participate in the study.~   "
91330|NCT01861769|"~     Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their~     lifetime. In the military veteran population, the lifetime prevalence of PTSD has been~     estimated to be as high as 20%. Numerous research studies have demonstrated that short-term,~     cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to~     substantial improvements in PTSD symptoms. However, research suggests that a minority of~     clinicians provide these therapies in clinical settings. The transfer of this research~     knowledge into clinical settings remains one of the largest hurdles to improving the health~     of Canadians with PTSD.~      It is well established that attending a 2-day workshop on these therapies alone is~     insufficient to promote adequate knowledge transfer and sustained skillful use. The current~     study aims to contrast whether two forms of post-workshop support (6-month duration), with~     different levels of expert oversight, will result in superior levels of clinician skill and~     patient outcomes versus no formal post-workshop support. The three forms of post-workshop~     support are 1) technology-enhanced group tele-consultation 2) standard group~     tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the~     assessment of the clinicians' competence in CPT and patient symptoms,respectively. This~     study will inform how best to transfer evidence based therapy outcomes to the clinical~     milieu to attain comparable outcomes as those observed in research.~      The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group~     tele-consultation condition will evidence the highest levels of fidelity, the standard group~     tele-consultation condition will evidence intermediate levels of fidelity, and the~     no-consultation/fidelity monitoring only condition will evidence the lowest fidelity.~     Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be~     positively associated with improved client outcomes. Hypothesis 3: Organizational context~     variables, such as the organizational climate and readiness for change, will influence the~     uptake of CPT skills, as well as the extent to which these skills are utilized in practice.~   "
91331|NCT01861756|"~     A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision~     aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool~     will serve as a facilitator for the Shared Decision Making process.~   "
91332|NCT01861743|"~     Most patients undergoing surgery experience significant post-operative pain. Inadequate~     peri-operative pain management may decrease post-operative mobilization and increase length~     of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is~     associated with an increased risk of developing chronic pain and delayed wound healing.~      Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization.~     The most common post-operative analgesia used in spine surgery is narcotic medication~     delivered via an intravenous patient controlled analgesia (IV PCA).~      A multimodal peri-operative pain management protocol for spine surgery has the potential to~     not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease~     length of stay in the hospital and reduce both direct and indirect hospital costs.~      The purpose of this study is to determine if post-operative pain and rate of recovery are~     improved in patients undergoing spine surgery using MMA compared to usual analgesic care.~   "
91333|NCT01861730|"~     Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and~     dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly~     in Bacille Calmette-Guerin (BCG) primed infants.~   "
91334|NCT01861717|"~     If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth~     hormone) the treatment is to have it surgically removed. This study has two phases.~      The first phase provides medical treatment with a drug that will be provided for 3 months~     before surgery to see if complications of surgery are reduced and to see whether or not~     remission improves following surgery if you have this medical treatment. The drug~     administered is approved by the FDA for long-term treatment of acromegaly. It is not~     routinely administered before surgery, and is therefore experimental as used in this way.~     All other procedures performed during this research are standard of care with the exception~     of the 3 questionnaires to be completed at each visit.~      The second phase of this study is from 3 months until 12 months after surgery and is only~     for people who do not go into remission after the operation. This phase assesses the~     possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9~     months. The drug will be prescribed by your physician as part of your regular medical care~     and will not be included as part of the study. All other procedures performed during this~     research are standard of care with the exception of the 3 questionnaires to be completed at~     each visit.~      The study lasts approximately 16 months - 3 month before surgery and 12 months after~     surgery.~   "
91335|NCT01861704|"~     Randomized post market study comparing Lyric to Lyric2 capturing information regarding~     comparative performance and safety.~   "
91336|NCT01861691|"~     The long-term results of several large-scale prospective randomized trials that compared~     laparoscopic-assisted and open colectomy for colon cancer were published in the past decade.~     The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open~     surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to~     compare oncological outcomes between patients who underwent laparoscopic or open surgery for~     advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were~     concerning tumor site in transverse and descending colon. The reason of exclusion was that~     laparoscopic procedure was difficult in transverse and descending colon cancers. However,~     laparoscopic surgery for transverse and descending colon cancer was performed clinically. We~     conducted a randomized trial that compared laparoscopic surgery and conventional open~     surgery in in transverse and descending colon cancer. The purpose of the present study was~     to clarify the safety and feasibility of laparoscopic surgery on in transverse and~     descending colon cancer patients.~   "
91337|NCT01861678|"~     The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure~     technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic~     artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is~     performed in practice. However, there is no evidence that shows effectiveness of this~     technique.~      We conducted a randomized trial that compared between high tie and low tie of the IMA in~     rectal anterior resection to define an appropriate portion of IMA tying.~   "
91339|NCT01861652|"~     Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on~     quality of life, and often times can be difficult to diagnose and treat effectively. RLS is~     typically treated with medical therapy (including dopaminergic agents, dopamine agonists,~     benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either~     refractory to medical therapy, have contraindications or adverse reactions to the available~     medical therapies, or desire conservative non-medication based therapies. Two previous~     studies have demonstrated that pneumatic compression devices placed on the legs can improve~     symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg~     compression device improves symptoms and quality of life measures related to RLS in up to 40~     patients evaluated prospectively for one month. This is a pilot study to assess the~     subjective response of our cohort of patients to this device prospectively. Our hypothesis~     is that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS~     specific quality of life questionnaires.~   "
91340|NCT01861639|"~     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's~     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).~      Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive~     processes by inducing virtual and transient lesions, mimicking those observed in MCI. It~     has proven repeatedly its capacity to interfere with encoding-retrieval memory task.~     However, to date, only few imaging data exist on the cerebral pathways involved in encoding~     memory task. Moreover, the stability of TMS effects over time remains to be investigated. If~     proven to be a stable interfering challenge, TMS could be used to investigate the potential~     restoring effect of new medication in AD.~      The study is the pilot study of a larger clinical trial which aims to prove the utility of~     rTMS as a potential model for prediction of clinical efficacy using a combination of~     cognitive and neuroimaging endpoints.~   "
91341|NCT01861626|"~     The purpose of this study is to evaluate the bioequivalence (comparison of the rate and~     extent of the active substance into the body following single administration of the drugs)~     between the test product V0057 and a reference product after two single oral administration~     separate by 7 days.~   "
91342|NCT01861613|"~     At present, children less than 15 y of age have been regarded as a key group for hepatitis B~     immunization in China. However, there is not yet special immunization strategy for~     population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis~     B and immune response to HB vaccine among Chinese college students to uncover the need on~     universal mass vaccination or booster immunization only for students with HBV vaccination~     history against hepatitis B in Chinese college students to inform decision making.~   "
91343|NCT01861600|"~     The primary efficacy objective was to determine and compare stool composition (stool soap~     and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among~     the feeding groups.~   "
91344|NCT01861587|"~     The purpose of this study is to determine whether a new medical technology can help reduce~     post-operative pain. The new technology is called Transcranial Direct Current Stimulation.~   "
91345|NCT01861574|"~     The purpose of this research study is to investigate the effects of Transcranial Magnetic~     Stimulation on pain perception. TMS is a non - invasive technique that uses electromagnetic~     pulses to temporarily stimulate specificc brain area in awake people ( without the need for~     surgery, anesthetic, or other invasive procedures.~   "
91346|NCT01861561|"~     Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in~     juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous~     cyclophosphamide can improve renal outcomes, but considerably associated with infection.~     Although severe infection is the significant complication related to poorer prognosis for~     juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice~     for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous~     cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable~     with obtained high-dose regimen. There was lower number of severe infection episodes, but no~     significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose~     or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous~     cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of~     serious infection and improve overall patient outcomes.~   "
91347|NCT01861548|"~     The Polish Mother and Child Cohort is multicentre prospective study on different exposures.~      Prospective cohort study design enables identification of exposures that may influence~     pregnancy outcome and chil-dren's health, verification of such exposures by biomarker~     measurements and notification of any changes in exposure levels.~      The aim of the study is to evaluate the impact of exposure to different environmental~     factors during pregnancy and after birth on pregnancy outcome and children's health.~     Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic~     aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of~     intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory~     diseases, allergy and poor mental and physical development. It is also intended to explain~     the role of oxidative stress and nutritional status of the pregnant women. The impact of~     occupational exposures and stressful situations on pregnancy outcome will be evaluated from~     question-naire data.~      The results of the study will help to determine levels of child prenatal and postnatal~     exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and~     children's health.~      This protocol concerns the children that are followed-up from birth to the age of 2 years to~     determine long term effects of pre- and postnatal environmental exposures.~   "
91348|NCT01861535|"~     To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod~     vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).~   "
91349|NCT01861522|"~     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after~     two weeks of administration to pediatric patients with perennial allergic rhinitis and to~     investigate safety of TAU-284.~   "
91350|NCT01861509|"~     This study is an open label, non-randomized phase I single-armed study in women with~     metastatic breast cancer (MBC) who have previously undergone all available standard~     chemotherapy regimens. The purpose of the study is to estimate the pharmacokinetics (PK)~     after single dose and multiple dose of BP-C1, investigate interleukin levels during BP-C1~     treatment and assess treatment response according to RECIST criteria.~   "
91351|NCT01861496|"~     Liposomal formulations are frequently used today in the treatment of cancer. LiPlaCis is the~     first targeted liposomal formulation with a tumour triggered release mechanism to undergo~     clinical development in oncology and it is expected that LiPlaCis will improve the~     therapeutic index of cisplatin compared to conventional cisplatin.~      Cisplatin is one of the most widely used drugs in the treatment of cancer due to its~     documented efficacy in a number of tumour types. Furthermore, it seems highly likely that~     cisplatin will remain an important drug in the future treatment of cancer. However, the drug~     is associated with a number of serious toxicities that complicates or necessitates~     discontinuation of therapy - e.g. need for pre-hydration, neurotoxicity, nausea and~     vomiting.~      Thus, there is a well-established need for improving cisplatin therapy in cancer patients.~     One option here is improving the formulation of the drug, so that a more selective up-take~     of cisplatin administered takes place at the tumour sites.~      Based on the results of the pre-clinical studies of LiPlaCis, it seems clear that LiPlaCis~     offers the potential to improve cisplatin therapy to the benefits of cancer patients.~      In a prematurely stopped Phase I Dutch study a Recommended Dose (RD) for a Phase II study~     was never reached which is now the aim of this Phase I dose escalating study.~      At the RD level in this study, patients will preferably have advanced breast cancer with a~     biopsy examination showing a pattern compatible with sensitivity to LiPlaCis~   "
91352|NCT01861483|"~     To investigate the vessel resection and reconstruction in biliary tract cancer.~   "
91353|NCT01861470|"~     More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United~     Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP).~     Less than 1 in 10 need treating, but to identify these all of them require eye examinations~     1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost~     considerable time and money.~      There is now a new urine test that might help identify babies with the highest risk of~     developing significant ROP. This cheap test appears to predict which babies need treatment~     and could avoid invasive eye examination in thousands of babies. The test has so far only~     been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice.~     We need to test more babies including in the UK. This study is designed to test >300 UK~     babies to see how accurately urine levels of NTproBNP predict development of ROP needing~     treatment.~      We will also pool our data with other researchers across Europe testing the same test to~     identify the best 'cut'-off' value for this test. In the future babies with urine levels of~     this chemical lower than this cut-off level would not need invasive eye examinations.~      If this test works as we hope it will many babies will avoid repeated painful eye tests, and~     their families will be saved the stress of watching this being done, by replacing these with~     a simple easy cheap pain free urine test. There will be substantial savings in health care~     costs that could be used to improve other aspects of care. In resource poor settings without~     an expert ophthalmologist babies could be screened for ROP that currently cannot be~     screened.~      We hope to demonstrate this to be a family-friendly, achievable intervention that positively~     impacts on the lives of babies and families experiencing neonatal intensive care.~   "
91354|NCT01861457|"~     The purpose of this study is to determine the extent to which bacterial growth in the~     nostrils by S. aureus, a common bacteria that is found in hospital environment, can be~     reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical~     10-hour work period in participants known to have S. aureus in their nose passages.~   "
91355|NCT01861444|"~     This prospective, multicenter, observational study will assess the prevalence of chronic~     hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of~     Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients~     treated with Pegasys according to current medical practice will be followed until 24 weeks~     after the end of treatment.~   "
91356|NCT01861431|"~     The proposed study aims to test the feasibility and preliminary efficacy of a combined~     4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34~     training session and matched savings) to reduce unprotected sex and to increase proportion~     of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar,~     Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical~     trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility~     screening, eligible women will complete informed consent, a baseline assessment, and be~     randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus~     microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.~      The study design will permit us to:~        1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance,~          retention data collection) of a combination HIV sexual risk reduction and MF~          intervention with high risk women in Ulaanbaatar, Mongolia;~        2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of~          vaginal and anal intercourse; increasing the proportion of protected vaginal and/or~          anal acts using barrier protection and decreasing number of sexual partners with~          repeated measures at baseline, immediately post-intervention, and 3 and 6 month~          follow-up assessments.~        3. Use the results of the pilot study to inform the design of a future R01 application.~   "
91357|NCT01861418|"~     The purposes of this study are:~        1. To examine the within-day and between-day test-retest reliability of a testing protocol~          measuring the back and hip muscles fatigability using EMG median frequency~        2. To examine the immediate and the carry-over effects of the lumbopelvic manipulation on~          the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and~          gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)~        3. To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the~          EMG median frequency between the participants who will receive lumbopelvic~          manipulation.~      The research hypotheses are:~        1. The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED~          and GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest~          reliability.~        2. The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease~          immediately after the lumbopelvic manipulation and will be maintained over two to four~          days following the manipulation.~        3. The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after~          the intervention in the manipulation group while no change will occur in the placebo~          group.~   "
91369|NCT01861262|"~     The primary purpose of the protocol is to evaluate the StO2 performance measured at the~     admission to the emergency department to identify hemodynamic failure at the admission or~     within the first three hours of monitoring patients with drug poisoning.~      The study hypotheses are:~        -  The early detection of hypoperfusion by StO2, essential to prevent the development of~          collapse.~        -  To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning,~          hospital stay and cost.~   "
91358|NCT01861405|"~     The investigators seek to perform an observational study in patients with brain metastases~     that are to undergo whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS)~     treatment in order to quantify any baseline neurocognitive changes which may result from~     intracranial disease burden, from radiation treatment (WBRT or SRS), or both. To do so, the~     investigators will compare matched control subjects to patients at time points obtained~     before and after radiation treatment with either SRS or WBRT. Pre-treatment evaluation will~     include neurocognitive testing and an assessment of fMRI task-related activation patterns~     and resting state brain activity. Four and twelve month post-treatment neuropsychological~     evaluations will be performed and pre- and 4-month post-treatment fMRI scans will be~     obtained in order to evaluate changes in neurocognitive functioning with a focus on~     short-term memory and executive function domains. A brief quality of life assessment will~     also be completed at each study time point. In order to plan treatment strategies in the~     future it is important to accurately document the effects of intracranial disease burden as~     well as radiation treatment on neurocognitive functioning, validate fMRI activation tasks~     for short term memory and executive functioning, and quantify the activation volumes that~     would potentially be spared in future cognitive sparing protocols.~      The investigators hypothesize first that the amount and location of intracranial disease~     burden will represent pre-treatment variables that affect NCF. The compromised NCF will be~     visualized in both the resting state and task-oriented neurocognitive exercise. The~     investigators anticipate that any perturbation in resting state caused by intracranial~     disease burden should be reflected in patients when compared to matched controls.~      The investigators hypothesize additionally that cancer patients with brain metastases~     undergoing radiation treatments will have improved intracranial disease control at the~     expense of executive and memory function with differences between patients that undergo~     stereotactic radiosurgery or whole brain radiation alone.~   "
91359|NCT01861392|"~     Background: The individual's ability to sustain itself in the upright position, effectively~     adjusting the body's movements and reacting to external stimuli, postural control strategies~     represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is~     considered a more problem of Public Health as having complications deficit in functional~     performance of the lower limbs and falls, which can interfere with the maintenance of~     balance, and is a strong predictor of functional limitations self referred. Aim: To assess~     quality of life and the answers neuromuscular balance and baropodometric after sensory-motor~     training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged~     between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and~     2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance,~     baropodometry, electromyography strength and joint position sense), as well as~     questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for~     12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with~     monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of~     intervention. Statistical analysis will be used normality test to verify the data~     distribution and consistent statistical test for the appropriate comparisons within and~     between groups, and adopted a significance level of 5%. Expected Results: Considering~     previous studies that demonstrate improvement in postural balance static and dynamic~     responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2,~     is expected to improve neuromuscular, balance, distribution plant, the joint position sense~     and the quality of life of voluntary DM-2.~      Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes~     Mellitus, quality of life.~   "
91360|NCT01861379|"~     To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a~     prospective randomized controlled study comparing 2 groups of patients undergoing anterior~     resection of the rectum laparoscopically. In the first group of patients at the end of the~     procedure was always performed a Ghost Ileostomy while in the second group no protective~     stoma was built at the end of the intervention.~   "
91361|NCT01861366|"~     The aim of this study is to examine two implementation strategies (external facilitation and~     educational outreach visit) when introducing nutritional guidelines in the elderly care~     setting and to evaluate the results of the implementation by clinical outcome measures of~     the nursing home residents.~      The hypothesis is that the residents affected by the external facilitation strategy will~     stay stable in the measured clinical outcomes, while the residents influenced by the~     educational outreach visit will deteriorate during the implementation process.~   "
91362|NCT01861353|"~     Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and~     in adults in our earlier clinical trials. The preventive effect was, however, observed late~     in the follow-up and the next recurrence was not prevented in children. The investigators~     hypothesize that cranberry-lingonberry juice should be started already during the~     antimicrobial treatment of acute urinary tract infection in order to maximize the preventive~     efficacy of the juice. In addition, the investigators aim to find the explanation for the~     efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical~     composition of urine and feces as well as the changes of gut microbiota.~   "
91363|NCT01861340|"~     This research study is being done to see if combining the investigational chemotherapy drug,~     MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your~     myeloma cancer stem cells.~   "
91364|NCT01861327|"~     Prospective randomized comparison between endovascular procedures performed with iodinated~     contrast or carbon dioxide as intraarterial contrast.~   "
91365|NCT01861314|"~     This phase I trial studies the side effects and the best dose of bortezomib and sorafenib~     tosylate when given together with decitabine in treating patients with acute myeloid~     leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving bortezomib and~     sorafenib tosylate together with decitabine may work better in treating acute myeloid~     leukemia.~   "
91366|NCT01861301|"~     This phase II trial studies how well tivantinib works in treating patients with previously~     treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
91367|NCT01861288|"~     We hypothesize that the number of needed endoscopic procedure performed at IBD patients~     (adult and children), can be reduced by using an individualized algorithm of symptoms, blood~     and faecal biomarkers.~      The aim of the study is to reduce the numbers of endoscopies, as the procedure is~     uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood~     test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we~     want to construct an algorithm by which the intestinal healing can be foreseen without~     performing an endoscopy.~      Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score,~     with the histo-pathological inflammation score from intestinal biopsies and the~     immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order~     to assess the gold standard - endoscopic remission.~   "
91368|NCT01861275|"~     Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In~     prospective study the investigators want to know how many ischaemic stroke patients have~     sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.~   "
91370|NCT01861249|"~     Primary Objective:~      To assess the long term safety and tolerability of SAR339658~      Secondary Objective:~      To assess the long term efficacy of SAR339658~   "
91373|NCT01861210|"~     This is a study to determine whether testing for HIV together as a couple, as opposed to~     testing separately, in acceptable to men in male couples, and is a safe prevention service.~     Testing of couples together has been provided for decades in Africa, but has never been~     tested in the United States. In this study, male couples will be enrolled and randomly~     assigned to be tested together in the same room, or separately. At the time of testing,~     investigators will ask questions about how they felt about the service they received. Three~     months later, investigators will survey the men again, and determine whether they had any~     problems after the testing, like violence in the relationship or the relationship breaking~     up. The main outcomes are being satisfied with the testing service, and safety (lack of~     intimate partner violence or relationship termination). Although the study is not designed~     to determine if the service reduces risk behaviors for HIV transmission, investigators will~     examine data on risks just to explore that topic. The main hypotheses are: (1) men will be~     at least as satisfied with couples testing as they are with individual testing; and (2) men~     tested as couples will not experience higher rates of intimate partner violence or~     relationship dissolution, relative to men tested separately.~   "
91374|NCT01861197|"~     Efficacy of Dovitinib for Squamous NSCLC.~   "
91375|NCT01861184|"~     We are interested in developing new and better ways of diagnosing the cause of lower~     respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria~     or virus) in less than 50% of patients with pneumonia. A potential way to better find the~     bug responsible may include checking for bugs in the nose by a nasal wash or swab. Better~     diagnostics would allow more targeted antibiotic therapy and in the future this technique~     may be used as a way of checking the efficiency of new vaccines.~      We are recruiting both patients with respiratory infections and also a 'control' group of~     patients admitted to hospital who do not have respiratory infection. We need to have access~     to your medical history information to make sure you are eligible and suitable for the~     study. If you participate in the study, it is important that the study doctors continue to~     have access to your personal Investigator Designation Contact telephone Dr Andrea Collins~     PhD student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof~     Stephen Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref:~     12/NW/0713 information so you can be followed up properly and so we can contact you during~     the study if needed.~      Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and~     urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6~     teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal~     Liverpool, in extreme circumstances this will occur at the patient's home).~   "
91376|NCT01861171|"~     The purpose of this study is to evaluate the effects of green tea on body weight, waist~     circumference, metabolic profile, inflammation, blood pressure and endothelial function in~     obese pre-hypertensive women.~   "
91377|NCT01861158|"~     This study evaluates Parenting Wisely (PW), an interactive, computer-based, online parenting~     program, through a formal randomized trial conducted in collaboration with the juvenile~     justice system (JJS), the primary market for such a program. Parents of 450 delinquent~     receiving JJS services as usual (SAU) will be randomly assigned to: PW plus a social~     networking online discussion forum, PW alone, or SAU. The investigators will also determine~     the potential marketability of the PW intervention to JJS programs based on the effects of~     PW on parent report and direct observation measures of parenting behaviors, adolescent~     behaviors, and family functioning, as well as measures of recidivism and cost savings. User~     satisfaction, program comprehension, receptivity, and parent self-efficacy will also be~     assessed. The investigators hypothesize that the two PW interventions (PW only and PW +~     Social Network) will produce greater reductions in disruptive behavior problems from~     baseline to 3- and 6-month assessments compared to SAU.~   "
91378|NCT01861145|"~     Enuresis (E) or bedwetting is a common pediatric complaint, and recent research has~     discovered a link with obstructive sleep apnea (OSA). In children, OSA is often secondary to~     enlargement of their adenoids or tonsils, and is often successfully treated with a steroid~     solution given through the nose.~      The relationship between SDB and E is incompletely understood. Airway obstruction affects~     the quality of sleep, as the child will wake as the oxygen levels drop. Abnormal sleep also~     can decrease the secretion of hormones that affects the kidney's ability to concentrate~     urine at night, which can result in too much urine in the bladder. Contemporary evidence~     also suggests that patients with enuresis have abnormal sleep phases, which may impair the~     communications and inhibition of the bladder.~      In previous studies, the investigators have demonstrated that children with E have a high~     likelihood of having concomitant SDB. The investigators have also demonstrated that children~     with E and symptoms of SDB do not respond to typical management for bedwetting. Therefore,~     the investigators propose to treat patients presenting with E with our standard treatments~     for E (bed alarm) and first line therapy for SDB: Intranasal steroids. This medication helps~     to decrease the inflammation of the adenoids and tonsils, thereby reducing the airway~     obstruction. the investigators hypothesize that children with significant symptoms of SDB~     will improve with the addition of INS, and the investigators hope to see an improvement in~     their bedwetting, quality of life, and sleep quality as well.~      To test this, patents with E will be recruited from the pediatric urology clinic. They will~     be offered the standard treatment for E, the bed alarm, and the treatment group will be~     given an intranasal steroid spray. The investigators will then reassess the patients 3~     months after treatment, and compare the two groups.~   "
91379|NCT01861132|"~     Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive~     monitoring devices are desirable, but until now, no equipment has proven validity. This~     study aims at validating the non-invasive monitoring device NexFin (second generation~     Finometer) in pregnant women.~   "
91388|NCT01861015|"~     Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female~     genital tract and the leading indication for hysterectomy. Although hysterectomy is the~     definitive treatment of myomas, myomectomy remains the gold standard treatment for women~     desiring future fertility and uterine conservation3. However, bleeding is often a problem in~     myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic~     infection, and adhesions with infertility.~      A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two~     categories of interventions can be identified: (a) Vascular interventions on uterine and/or~     ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic~     interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol,~     sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative~     local injection of vasopressin causing vasospasm is most commonly used. However, there is~     not a wide consensus on the use of this agent because of serious side effects reported in~     literature. In addition, in several countries, including France and Italy, vasopressin has~     not been commercialized because of its potential adverse effects on cardiovascular system.~      Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of~     vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological~     surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However,~     there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy.~     Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents~     during myomectomy has never been conducted. To test the hypothesis that the injections of~     epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the~     investigators performed this randomized controlled study.~   "
91380|NCT01861119|"~     Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The~     subjective opinion of the patient regarding the scar will often constitute the standard for~     judging the success or failure of the procedure. Surgical scars are not only a cosmetic~     concern but they can also cause pain, itching, discomfort, contracture, and other functional~     impairment. Various treatment options exists for treating hypertrophic scars and keloids,~     including intralesional steroid injection, dermabrasion, pressure therapy, surgical~     excision, radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However,~     these treatments often require multiple visits and have limited success. Therefore,~     prevention and early recognition of hypertrophic scars and keloids are very important in~     their management.~      Among preventive treatments available, silicone gel and onion extract gel have been marketed~     as products to improve the appearance and texture of surgical scars. Despite its popularity,~     data demonstrating the efficacy of these gels are lacking. Furthermore, there is no~     comparative study of silicone gel and onion extract gel for preventing postsurgical~     hypertrophic or keloid scars. The investigators therefore conducted this randomized~     controlled trial to compare the efficacy of silicone gel and onion extract gel for the~     prevention of postsurgical hypertrophic scars. The investigators also compared patient~     compliance and side effect between two topical gels.~   "
91381|NCT01861106|"~     Background:~      - GATA2 deficiency is a disease caused by mutations in the GATA2 gene. It can cause~     different types of leukemia and other diseases. Researchers want to see if a stem cell~     transplant can be used to treat this condition. A stem cell transplant will give stem cells~     from a matching donor (related or unrelated) to a recipient. It will allow the donor stem~     cells to produce healthy bone marrow and blood cells that will attack the recipient s cancer~     cells.~      Objectives:~      - To see if stem cell transplants are successful at treating GATA2 mutations and related~     conditions.~      Eligibility:~        -  Recipients who are between 10 and 70 years of age and have GATA2 deficiency.~        -  Donors who are between 6 and 70 years of age and are matched with the recipients.~      Design:~        -  All participants will be screened with a physical exam and medical history. Blood~          samples will be collected. Recipients will have imaging studies and other tests.~        -  Donor participants will provide stem cells for the treatment. Filgrastim injections~          will allow these cells to be collected from the blood. In some cases, bone marrow~          donations will be needed to provide more stem cells.~        -  Recipients will have chemotherapy or radiation to prepare for the transplant. On the~          day of the transplant, they will receive the donated stem cells.~        -  Recipients will stay in the hospital until their condition is stable after transplant.~        -  Frequent blood tests and scans will be required for the first 6 months after the~          transplant, followed by less frequent visits over time.~   "
91382|NCT01861093|"~     Background:~      - Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns~     after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord~     blood units are stored frozen in public cord blood banks. About 10,000 cord blood~     transplants have been performed in children and adults for blood cancers and other diseases~     in the world. These transplants have helped save lives and improve treatments. However, not~     all available units of cord blood have been collected, stored, and licensed according to~     specific government requirements. These unlicensed units can still be used in transplant,~     but they can only be given as part of specific research studies. This study will evaluate~     the safety of giving these unlicensed units by recording any problems that may occur during~     and after giving the cord blood.~      Objectives:~      - To test the safety and effectiveness of unlicensed cord blood units in people who need~     stem cell transplants.~      Eligibility:~      - Individuals who are scheduled to have a stem cell transplant.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will receive the cord blood unit as part of their stem cell transplant~          procedure. The transplant will be performed according to the current standard of care~          for the procedure.~        -  After the transplant, participants will be monitored for up to 1 year. Any problems or~          side effects from the transplant will be treated as necessary. All outcomes will be~          reported to the National Cord Blood Program and to the Center for International Blood~          and Marrow Transplant.~   "
91383|NCT01861080|"~     The objective of this study is to know prevalence of clinical or subclinical target organ~     damages in Korea hypertensives by constructing nationwide hypertension registry. We will~     register 5000 consecutive patients with incident hypertension at 20 major university~     hospitals in South Korea. We will investigate clinical/subclinical target organ damages,~     renin/aldosterone level and cardiovascular events in each patient.~   "
91384|NCT01861067|"~     During the last 2 decades, several studies have tried to define the best surgical approach~     to hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that~     abdominal hysterectomy has a higher incidence of complications, a longer hospital stay and a~     slower convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage~     of LHs is the absence of a wide abdominal scar, which results in fewer wound-related~     complications and in a significant decrease of postoperative pain.~      Technologic advances in endoscopic instrumentation and optics have allowed the development~     of an even less invasive procedure than conventional LH using multiple ports:~     laparoendoscopic single-site (LESS) surgery, also known as single-port access (SPA)~     laparoscopy3. In the LESS approaches, total laparoscopic hysterectomy (TLH) and~     laparoscopically-assisted vaginal hysterectomy (LAVH) are all feasible, with comparable~     conventional LH. However, it is yet to be determined which of two alternative and less~     invasive approaches (LESS-TLH and LESS-LAVH) should be preferred. In particular, none has~     focused on postoperative pain as the primary outcome of the study. The investigators have~     therefore designed the randomized trial to investigate specifically differences in~     postoperative pain after LESS-TLH and LESS-LAVH.~   "
91385|NCT01861054|"~     This is a pilot window of opportunity clinical study in patients with operable breast~     cancer investigating use of reparixin as single agent in the time period between clinical~     diagnosis and surgery. This study evaluates the effects of orally administered reparixin on~     CSCs in the primary tumor and the tumoral microenvironment in an early breast cancer~     population. The aim is to investigate if cancer stem cells (CSCs) and pathway markers~     decrease in two early breast cancer subgroups (ER+ and/or progesterone receptor~     positive/HER-2- and ER negative/progesterone receptor negative/HER‑2-) and to compare any~     differences between the two subgroups to try to better identify a target population. 20~     patients will be enrolled to each subgroup at ten sites in the US.~   "
91396|NCT01860911|"~     Increased accumulation of fat into the muscles is associated with what is called~     insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to~     find out how fat circulating in the blood following fat consumption is taken up by the~     muscles in healthy people as well as people that are insulin-resistant. The investigators~     are specifically interested in how a hormone called insulin is involved in this process.~     Findings from this research will contribute to our understanding of why insulin-resistant~     people have increased accumulation of fat in their muscles, and ultimately help to design~     appropriate interventions to prevent type 2 Diabetes.~   "
91397|NCT01860898|"~     As part of the long-term goal of successfully implementing tissue regeneration strategies in~     an individualized manner for patients with thoracic diseases including, but not limited to:~     cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will~     assess the feasibility of collecting skin biopsies from patients undergoing surgery for~     thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin~     fibroblasts into induced pluripotent cells.~   "
91398|NCT01860885|"~     Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is~     associated with life-threatening respiratory depression requiring antagonism with naloxone.~     Hence, it is hypothesized that naloxone requirement can be used as a quality measure of~     opioid safety. A retrospective medical chart review of 95 patients, who received naloxone~     for life threatening events, from June 2006-2012, is planned, to identify significant~     factors associated with risk for opioid induced respiratory depression and formulation of~     preventive strategies.~   "
91399|NCT01860872|"~     The purpose of this research is to learn more about the heart and blood vessels in the lungs~     of people with cystic fibrosis (CF). This study will include approximately 36 children and~     adults with CF and 12 children and adults without CF. The study will involve one magnetic~     resonance imaging (MRI) . The research also includes blood samples to look at inflammation~     and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple~     Breath Washout test.~      For the CF subjects, enrollment will be timed to coincide with routine scheduled~     computerized tomography (CT) or the CF subject may choose to have a CT for research~     purposes. The MRI will be compared to CT images of the lungs. The goal is to develop better~     imaging that does not use radiation.~   "
91400|NCT01860859|"~     This study compares three techniques of uterine closure on myometrium thickness evaluated by~     ultrasound six months after the primary cesarean. The three techniques include: 1) locked~     single layer closure; 2) double layer closure with a first continuous locked suture and a~     second imbricating continuous suture; 3) double layer closure with a first continuous~     unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua~     and a second unlocked continuous suture that approximate the upper portion of the~     myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine~     scar evaluated by transvaginal ultrasound at six months after cesarean.~   "
91401|NCT01860846|"~     This post marketing observational study (PMOS) is designed to collect long-term data on the~     work productivity and changes in quality of life measurements with anti-Tumor Necrosis~     Factor therapies in patients with moderate to severe Crohn's disease whom are intolerant~     or/and unresponsive to conventional therapy.~   "
91402|NCT01860833|"~     Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local~     inflammation (which involves production of pro-inflammatory cytokines such as interleukin~     (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.~      Certain therapies that specifically interfere with the expression or actions of~     pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and~     anti-inflammatory properties and are extensively prescribed for several musculoskeletal~     disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently~     recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients.~     These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA~     patients with satisfactory relief of painful osteoarthritic joints.~      The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha,~     IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In~     particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that~     relationships between proinflammatory cytokines and the clinical status of OA patients are~     possible, we also evaluated the association between the concentration of these molecules in~     the osteoarthritic knee synovial fluid and the pain and functional status of patients with~     OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also~     investigated.~   "
91403|NCT01860820|"~     This will be a randomized, controlled trial involving kidney and kidney pancreas transplant~     patients. There will be 2 groups and patients will be randomized to one of the two; one will~     receive standard of care IPC or TED stockings to help with circulation, the other group will~     use the geko device which is a newer device with Health Canada approval. Clinical outcomes~     will be compared for those in each group and clinical differences between patients who~     receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.~   "
91404|NCT01860807|"~     The objective of this study is to test the safety and potential efficacy of ibudilast to~     treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce~     methamphetamine use and increase treatment retention more than placebo among patients~     seeking treatment for methamphetamine dependence. As HIV infection is a common complication~     of methamphetamine dependence, half of the participants will be HIV positive and the study~     will assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence,~     CD4 count, risk behaviors).~   "
91405|NCT01860794|"~     The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic~     Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.~   "
91406|NCT01860781|"~     The purpose of this study is the evaluation of effectiveness of paliperidone palmitate~     within three different group of schizophrenia patients.~   "
91467|NCT01859988|"~     To assess the efficacy of multiple dupilumab (REGN668/SAR231893) dose-regimens, compared to~     placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).~   "
91468|NCT01859962|"~     This study is designed to provide a preliminary assessment of the safety and effectiveness~     of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the~     treatment of chronic hepatitis C virus infection.~   "
91407|NCT01860768|"~     Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis~     rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and~     serious threat to human health. At present, the clinical diagnosis of AAD commonly used~     imaging methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest~     X-ray and two-dimensional ultrasound is limited in diagnosis of AAD, esophageal~     ultrasonography can display the intimal, identify the true and false lumen, but greater~     risk. CT, MRI and aortic angiography can be used as diagnosis method, but time-consuming,~     expensive and requires handling patients in emergency situations, should not be used as the~     preferred. Therefore, it is significance that biomarkers with high specificity and~     sensitivity for clinical fast diagnosis of AAD.~      Parts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy~     chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were~     significantly higher than that of others (normal people, acute myocardial infarction~     patients). But because of the small study sample, limited control risk factors and~     incomplete comparison, their conclusions were questionable. In our previous studies also~     found that serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are~     closely related. Therefore, on the basis, a prospective study is needed. We observe all the~     three biomarkers in enrolled patients with acute chest pain in emergency department, levels~     in healthy volunteers as the blank control. Then make definite diagnosis of the enrolled~     patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the~     early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.~   "
91408|NCT01860755|"~     The purpose of this study is to determine the effects of a combined physiotherapy treatment~     (including vestibular rehabilitation and treatment for the cervical spine) in youth and~     young adults with ongoing symptoms of dizziness, neck pain and headaches following a~     sport-related concussion.~   "
91409|NCT01860742|"~     The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b~     in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine~     tumors resistant to therapy with somatostatin analogues, in terms of disease control.~   "
91410|NCT01860729|"~     This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol~     (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with~     hypercholesterolemia when added to an existing statin therapy.~   "
91411|NCT01860716|"~     Impact of melatonin on organ donor pretreatment and liver transplant recipient: prospective,~     randomized, double-blind trial.~      OBJECTIVES. To establish the efficacy of the melatonin administered to encephalic death~     donors (EDD) in liver transplantation. The aim is to improve the functional quality of the~     retrieved organs, attenuate lesions and ischemia-reperfusion mediators, and provide grafts~     with greater resistance to post-transplant aggression.~      METHODOLOGY. Prospective, randomized, double-blind, pilot trial to evaluate preconditioning~     with melatonin versus placebo in EDDs. Two groups, melatonin and control-placebo, n=30 per~     group. Administration to donor via NG tube of 30mg of melatonin or placebo (lactose) upon~     inclusion in the trial, 60 minutes prior to commencement of surgery and following laparotomy~     during extraction. Evaluation of response to treatment: A) Conventional clinical,~     hemodynamic, analytical and histopathological parameters in donor and recipient. B) Plasma~     determinations for: oxidative/nitrosative stress; acute phase proteins; cellular and humoral~     immunity; NT-proBNP and cystatin C; endocrine profile; melatonin levels. C) Determinations~     in liver tissue: quantification of malonyldialdehyde-4hydroxyalkenals and protein carbonyl~     content; cellular and mitochondrial membrane fluidity; markers of tissue-vascular damage and~     proliferation: transforming growth factor-beta (TGF-β); hypoxia-inducible factor (HIF) and~     vascular endothelial growth factor (VEGF). Data will be analyzed following a prospectively~     define plan and by intention-to-treat analysis.~   "
91412|NCT01860703|"~     Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover~     study to evaluate the effect of deferiprone on QTc prolongation after administration of a~     single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in~     healthy volunteers as compared to placebo treatment.~   "
91413|NCT01860690|"~     The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for~     Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that BHCG level~     in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According~     to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the~     trophoblast tissue , and only day 10 is an indicator for treatment success~   "
91414|NCT01860677|"~     Use of the Fischer Wallace Cranial Stimulator to relieve symptoms related to PTSD.~   "
91415|NCT01860664|"~     The purpose of this study is to determine the safety and effectiveness of hydrocortisone~     ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.~   "
91416|NCT01860651|"~     The investigators hypothesize that E-health - web based monitoring of disease and treatment~     - in young patients with chronic inflammatory disease (IBD) can improve the disease course~     and quality of life.~      Adherence (to take the prescribed medicine) is difficult for young patients. In this~     E-health project the investigators seek to improve young patients (10-17 years)~     responsibility for treatment, to empower them and thereby enhance the adherence in order to~     achieve a more quiet disease course. Through the e-Health program and web-app the disease~     activity will be presented to the young patient via a simple traffic light chart and the~     patient will be guided to: continue the prescribed medication, call the physician or visit~     the out-patient clinic. In future the concept is believed also to be applicable for young~     patients with other chronic diseases.~   "
91417|NCT01860638|"~     This multicenter, double-blind, placebo-controlled, randomized study will evaluate the~     efficacy and safety of the addition of bevacizumab or placebo treatment to lomustine in~     second-line treatment and standard of care (SOC) in third-line treatment following disease~     progression after first-line treatment in participants with newly diagnosed glioblastoma.~     All enrolled participants will receive first-line treatment with radiotherapy, temozolomide~     and bevacizumab (10 milligrams per kilogram per week [mg/kg/week] intravenously [IV] every 2~     weeks). At the first disease progression (PD1), eligible participants will be randomized to~     receive lomustine plus either bevacizumab (10 mg/kg/week IV every 2 weeks) or placebo for~     2nd-line treatment. After further disease progression (PD2), participants will receive a~     standard of care agent and continued bevacizumab or placebo for 3rd-line treatment.~   "
91420|NCT01860599|"~     It is well known that diabetes and excessive or high blood sugars causes blood vessel and~     blood cell damage. It is also possible, then, that people with pre-diabetes may also start~     to have blood vessel and blood cell damage as the blood sugars rise from the normal range~     into the diabetic range. In addition to looking at potential damage, the question is whether~     or not this damage improves with exercise. This study aims to look at blood vessel and blood~     cells in three different ways by 1) looking at how the blood vessel responds to sheer~     force (a blood pressure cuff pumped up and then released after a few minutes). This is done~     by ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and~     inflammation and 3) By looking at certain blood cells in the lab, how long they live and the~     number of cells left after a certain number of days, and again, if this improves with~     exercise.~   "
91421|NCT01860586|"~     The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin)~     on the rates of recurrent retinal detachment and scar tissue formation.~   "
91422|NCT01860573|"~     The purpose of this study is to determine whether providing increased protein to premature~     infants in the first week of life allows for better growth during the hospital stay and~     improved developmental outcomes by age 2.~   "
91423|NCT01860560|"~     Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow~     Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the~     management of apnea / hypopnea index (AHI).~   "
91424|NCT01860547|"~     The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë~     rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on~     lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic~     diseases.~   "
91425|NCT01860534|"~     Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can~     persist for hours. Despite regular use of eye protection for mydriatic-induced light~     sensitivity for infants, children and adults, eye protection after mydriasis has not been~     addressed in neonates. This study examines the use of eye patches to protect the dilated~     pupil from light exposure and their impact on vital signs and pain scores. prevents~     tachycardia, tachypnea and discomfort in neonates after ROP screening.~   "
91426|NCT01860521|"~     This study included women who underwent voluntary second trimester termination of pregnancy.~     Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous~     epidural infusion for pain analgesia. In this randomized, double-blind study, the~     investigators assess the incidence of motor block (primary outcome), degree of satisfaction~     of the patients, total levobupivacaine and sufentanil consumption and adverse events~     (secondary outcomes) between the two study groups.~   "
91427|NCT01860508|"~     PFS~   "
91428|NCT01860495|"~     One of the most important elements suggested to be provided through membrane perforations to~     augment regeneration are cell released growth factors from the overlying periosteal and~     gingival cells. A direct correlation could exist between the number of such cells and their~     available released growth factors. To test this assumption, this study was designed to~     evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during~     the early stages of healing for sites treated by MPM compared to that of the occlusive~     barrier membranes.~   "
91429|NCT01860482|"~     The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in~     patients with refractory reflux esophagitis to the prior standard PPIs regimen.~   "
91430|NCT01860469|"~     Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will~     decrease rates of mesh infection~   "
91431|NCT01860456|"~     Rationale~      The pharmacokinetics of imatinib and nilotinib, two BCR/Abl tyrosine-kinase inhibitors~     (TKI), is variable among patients suffering from chronic myeloid leukemia (CML).~     Transmembrane transporters may play a pivotal role in interindividual variability in TKI~     disposition. Furthermore, minimum plasma concentrations (Cmin) higher than 1 mg/L could be~     associated with a higher likelihood of molecular and cytogenetic responses.~      Therefore, the TIKlet study is aimed at evaluating any possible correlation among the~     pharmacogenetics of transmembrane transporters, imatinib and nilotinib pharmacokinetics and~     treatment efficacy/tolerability in CML patients.~      1. PATIENTS AND METHODS~      1.1. Patients~      Patients affected by CML will be enrolled in the TIKLet study after the informed consent~     will be signed. The following inclusion criteria will be adopted:~        -  patients of both sexes,~        -  age between 18 and 80 years,~        -  treated with imatinib or nilotinib,~        -  included in the follow-up in the Divisions / Units of Hematology involved in the~          project,~        -  able to give informed consent to trial participation,~        -  with a proved compliance with the scheduled treatment.~      The administration of other drugs will be allowed, but active pharmacological agents, their~     dose and duration of treatment should be known.~      Smoking and herbal products will be allowed but they should be recorded. Alterations in~     liver and kidney functions, body mass index >28, or any other alteration in physicochemical~     exams does not represent exclusion criteria.~      1.2. Enrolment and follow-up visits~      During enrolment visit, the following activities will take place:~        -  patients will be informed about the characteristics, objectives, and procedures of the~          study.~        -  Patient's consent to study participation will be confirmed by signing the informed~          consent form.~        -  Assignment of personal alphanumeric code.~        -  Collection of main data of the patient within the individual case report form (CRF).~        -  Collection of a blood sample (approximately 4 mL). At follow-up visits, a blood sample~          (approximately 4 mL) will be collected for therapeutic drug monitoring of drugs and~          patients' CRF will be updated. The blood sample and all of the records will be sent to~          the Dept. of Clinical and Experimental Medicine, University of Pisa.~      1.3. Blood samples~      Each tube containing the patient's whole blood, plasma or DNA and used for the execution of~     therapeutic monitoring or pharmacogenetic analyses will be identified by a) the patient's~     code and b) the date of execution of blood withdrawal.~      After centrifugation of the blood sample, the resulting plasma (1.5 mL) will be collected~     and stored in an eppendorf tube for the measurement of drug concentrations. During the~     enrolment visit, an aliquot of whole blood (0.5 mL) will be collected in a sterile eppendorf~     tube for molecular analyses. Both samples will be stored at -20 °C for a maximum of 2 weeks,~     then they will be sent to the Dept. of Clinical and Experimental Medicine, University of~     Pisa.~      1.4 Laboratory analyses~      The following analyses will be conducted at the Department of Clinical and Experimental~     Medicine, University of Pisa and at the Department of Pharmacology, University of Bologna.~      Plasma concentrations of drugs (i.e., imatinib and its metabolite, nilotinib) will be~     measured by high-performance liquid chromatography systems. Values of plasma concentrations~     will be analyzed by a population pharmacokinetic analysis to obtain main pharmacokinetic~     parameters (i.e., clearance of the drugs). Those parameters will help to describe in a~     quantitative manner drug disposition into every patient.~      Furthermore, DNA will be extracted from whole blood and genetic variants (called single~     nucleotide polymorphisms) will be investigated in the following genes that code for~     transmembrane transporters: ABCB1, ABCG2, hOCT1, OCTN1, OATP1A2.~      Finally, response to drugs, in terms of Major Molecular Response (MMR) and Complete~     Cytogenetic Response (CCyR), and tolerability will be evaluated. Any possible correlation~     among drug disposition, pharmacogenetics and treatment effects will be analyzed.~   "
91432|NCT01860443|"~     Background: Depression is common in adolescents and it is associated with serious~     consequences. In Chile, primary care team has a leading role in the management of depression~     in adolescents. Nevertheless, the majority of primary care professionals report not feeling~     adequately prepared to take on this responsibility and having difficulties referring~     patients to specialists. This situation is particularity complex in regions far away from~     the central zone. Telepsychiatry is a potential solution to an equitable access to~     specialized clinical expertise.~      Purpose: The purpose of this study is to determine whether a telepsychiatry-based~     collaborative program is effective to improve the management of depression in adolescents~     between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.~      Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents.~     The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program~     will be evaluated.~   "
91433|NCT01860430|"~     This clinical trial is aimed to establish a recommended starting dose of ipilimumab for a~     future efficacy trial when used in combination with intensity modulated radiation therapy~     (IMRT) and cetuximab.~   "
91434|NCT01860417|"~     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells~     (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc~     Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al.,~     Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective,~     randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing~     Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists~     of two arms with 12 patients each one. Patients in the experimental arm will be given a~     single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be~     infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We~     shall follow the evolution of pain, disability and quality of life as well as disc fluid~     content by Magnetic Resonance Imaging (T2-calibrated).~   "
91435|NCT01860404|"~     This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory~     clinical trial of branched chain amino acids (BCAA's) in the treatment of sports-related~     concussion. The aim of the study is to determine whether, compared to placebo treatment,~     administration of BCAA's, at one or more doses, after a sports-related concussion improves~     neurocognitive recovery at one or more time-periods post concussion.~   "
91469|NCT01859949|"~     To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA)~     without epiphyseal closing.~   "
91846|NCT01855009|"~     This study will compare changes in body composition (lean mass, fat, and bone)and parent~     ratings of quality of life in 5-19 Year Olds as a function of participation in one of four~     versions of the Good NEWS 4 Kids Program (GN4K).~   "
91436|NCT01860391|"~     The aim of the study is to measure salivary fluoride and silver levels up to 7 days~     post-treatment.~      The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to~     use the day before the study and all during the study.~      3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated~     each on the facial aspect (Group B).~      On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in~     the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3~     times.~      On day 0, 10 minutes after the rinsing and spitting, the participant will provide a~     unstimulated salivary sample into a universal collection tube until 5 ml are collected. The~     tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at~     the University of Washington.~      On Day 0, Isolation and application of silver fluoride.~      The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered~     with petroleum jelly to provide additional protection.~      After application, participant will be given 25 ml of fluoride free water to rinse as in 1~     above and water collected. This will be done 10 times.~      DAY 1-6 Salivary Collection~      Measures: Fluoride will be measured using standard fluoride electrode analysis~     (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass~     Spectrometry (EPA 6020a Rev.1 2007) at the University of Washington~   "
91437|NCT01860378|"~     This study is a small-scale randomized, placebo-controlled factorial trial of two~     interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization~     rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap~     voucher with or without an educational video.~   "
91438|NCT01860365|"~     In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility~     of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS~     established the Integrative Oncology Program with the goal of addressing patient concerns~     and improving quality of life parameters during chemotherapy and advanced disease. The study~     hypothesis is that integrated medicine consultation and treatment provided within the~     oncology department may improve patients' concerns and well-being.~   "
91439|NCT01860352|"~     The purpose of this study is to see what effects the dietary supplement called Omega-3 or~     Fish Oil and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms~     (pills, capsules, liquid) in grocery stores, health food/vitamin stores and drug stores and~     from eating fish. We would like to learn if different amounts of Fish Oil specifically~     chosen for you individually change your colon tissue (large intestine). We hope that Fish~     Oil may be useful in the future as something that may help to prevent colon cancer, but we~     don't have any research in humans that shows that yet. We have to do this study first to see~     if Fish Oil effects the colon. One type of Fish Oil is has been approved by the U.S. Food~     and Drug Administration (FDA) to reduce the risk of heart disease. We are going to test a~     different Fish Oil supplement made by a company called Nordic Naturals.~      The colon lining or mucosa comes in contact with all the undigested things we eat or drink~     as it passes out to waste (stool). Animal studies suggest that fish oil may help the colon~     lining by reducing colon polyps and therefore colon cancer. We think this happens through~     chemical changes in the colon lining and also in the blood. The chemicals that we are~     looking at are called fatty acids. We want to see if taking different amounts fish oil~     chosen for you changes these chemicals (fatty acids) in your colon or your blood. We will~     assign you a personal low dose of fish oil to take for 2 weeks, followed by a high dose,~     or maximum dose for 2 weeks. We will calculate your basal Metabolic Rate (BMR) from your~     height, weight, age and assess your activity factor. We have a table that then tells us your~     target low and high dose. Then, based on your blood samples, we figure out which target dose~     is the one for you that will change these chemicals (fatty acids) by about ½ (50%). We will~     check how well this process worked by collecting small pieces of colon tissue (biopsies) of~     the colon before any fish oil and after all the fish oil is consumed. We will also use blood~     samples to test for these fatty acids and a few others. We are going to collect diet~     information at several times throughout the study so we can see if the food you eat makes a~     difference too.~      We hope to learn a lot about how fatty acids are metabolized (broken down or used) in the~     colon directly in combination with Omega-3 supplements.~   "
91440|NCT01860339|"~     Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of~     cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat~     (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been~     conceptualized as a neurodegenerative disease. However, recent evidence suggests that~     abnormal brain development may play an important role in the etiology of HD. Huntingtin~     (HTT)is expressed during development and through life. In animal studies, the HTT gene has~     been shown to be vital for brain development. This suggests that a mutant form of HTT~     (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In~     addition, studies in adults who are gene-expanded for HD, but have not yet manifested the~     illness, (pre-HD subjects) have significant changes in the structure of their brain, even up~     to 20 years before onset of clinical diagnosis. How far back these changes are evident is~     unknown. One possibility is that these brain changes are present throughout life, due to~     changes in brain development,though initially associated with only subtle functional~     abnormalities.~      In an effort to better understand the developmental aspects of this brain disease, the~     current study proposes to evaluate brain structure and function in children, adolescents,~     and young adults (ages 6-18) who are at risk for developing HD - those who have a parent or~     grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging~     (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white~     matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive~     tests, physical and neurologic evaluation, behavioral assessment, and quantitative~     craniofacial structure assessment. Subjects that are gene-expanded (GE) will be compared to~     subjects who are gene non-expanded (GNE) and as well to matched healthy controls. Changes in~     brain structure and/or function in the GE group, compared to both GNE and control groups,~     would lend support to the notion that this disease has an important developmental component.~   "
91441|NCT01860326|"~     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of~     single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment~     compared to matched healthy subjects with normal liver function.~   "
91442|NCT01860313|"~     The purpose of this study is to create a web-based interactive educational environment to~     train elementary teachers, to identify children and adolescents in need of specialized~     mental health care and give them some advises in managing problematic children in class.~     After the creation of such an educational environment the psychoeducational project was~     tested in order to verify it's effectiveness.~   "
91443|NCT01860300|"~     This study is an extension of the European Multicentre Tics In Children Studies (EMTICS)~     COURSE study for which a separate study protocol exists; Aim of this clinical trial is to~     study the efficacy of treatment with antibiotics in reducing severity of tics and associated~     neuropsychiatric symptoms in patients with a tic disorder colonised by GAS.~      Primary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation~     compared to placebo is associated with a larger reduction of tic and associated~     neuropsychiatric symptoms in the short-term (1 month) in patients with a tic disorder~     colonised by GAS.~      Secondary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation is~     superior to placebo in the long-term (1 year) reduction of tic and associated~     neuropsychiatric symptoms in patients with a tic disorder colonized by GAS.~      Patients affected by a chronic tic disorder followed in the EMTICS- Longitudinal Course~     Study that show a positive culture for GAS at any microbiological examination during their~     follow-up will be considered eligible for the treatment trial.~      Patients showing GAS positivity will be invited to participate in the clinical trial.~      The patients enrolled will be randomly assigned to antibiotic or placebo in a 1:1 ratio.~      All participating patients will undergo a microbiological, serological and clinical~     assessment 1 month after the date of entering in the treatment trial (i.e. around 20 days~     after the end of treatment). Then, the patients will be followed with clinical, laboratory~     and microbiological assessments every four months for 1 year.~      Patients will be deblinded at the end of the treatment trial follow-up (1 year after the~     recruitment).~      Patients who will develop a true GAS infection or who otherwise need to be prescribed~     antibiotics for any clinical reason during the follow-up will be withdrawn from the study~     and immediately deblinded. Data of such patients would, however, remain part of the study~     analyses, following the intention-to-treat principle.~   "
91444|NCT01860287|"~     In this study, the investigators will examine the effects of buprenorphine, as compared to~     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task~     and a non-stressful control task in healthy adults. There is strong evidence in support of~     the role of endogenous opioids and opiates in mediating social behavior in humans and other~     animals, and particularly, in social distress. Recently it has been shown that~     buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful~     facial expressions in humans. Here, the investigators propose to further explore the role of~     the opioid system in mediating stress responses in humans through the use of buprenorphine.~     The investigators hypothesize that buprenorphine with reduce both physiological and~     subjective measures of stress.~   "
91445|NCT01860274|"~     The study hypothesis is that a meshed conduit made of safen vein allows a better patency at~     mid-long term than a safen vein alone.~      To test this hypothesis the investigators plan a prospective, randomized study, comparing~     grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will~     be performed one year after the operation.~   "
91446|NCT01860261|"~     This pilot study will test the feasibility and acceptability of a 12 week combined aerobic~     and strength training intervention among persons with HIV who are age 50 or older and do not~     exercise frequently, and its preliminary effects on aging-related outcomes . The study uses~     an randomized, controlled trial design and is intended to lead to a larger clinical trial~     with long-term follow-up. The intervention incorporates small group instruction from a~     trainer, a small wearable accelerometer to provide accurate data on physical activity, and~     real-time feedback to participants about exercise levels. The primary outcome measure will~     be changes in fitness, measured as change in maximal oxygen consumption (VO2 max). The~     control group will receive a comparable exercise intervention after they complete 12 weeks~     of observation.~   "
91447|NCT01860248|"~     This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed~     with vapocoolant spray in comparison to placebo.~   "
91448|NCT01860235|"~     Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some~     disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening~     of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a~     skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and~     injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.~   "
91449|NCT01860222|"~     The aim of this study is to compare the operative complication and short-/long-term~     therapeutic effects of percutaneous local ablative therapy (PLAT) versus surgical~     resection(SR) on small hepatocellular carcinoma(HCC) patients with clinically significant~     portal hypertension(CSPH) so as to lend clinical and theoretical basis of the therapeutic~     schemes for the disease.~   "
91450|NCT01860209|"~     The purpose of this study is to investigate the effect of decreasing fluid overload by~     hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic~     kidney disease on intermittent hemodialysis. It aims further to investigate the relationship~     between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.~   "
91451|NCT01860196|"~     This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical~     dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double~     blind, Randomized, Clinical trial.~   "
91452|NCT01860183|"~     Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of~     long-term kidney function deterioration and ultimately graft loss. It results from both~     immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive~     drug used for prevention of rejection after kidney transplant, usually in combination with a~     calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides~     immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent~     immunosuppressive effects and is the cornerstone of contemporary posttransplant~     immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The~     hypothesis of the present study is that in the setting of similar net immunosuppression,~     higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during~     first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present~     study will randomly assign low immunological risk kidney transplant recipients to either 2g~     or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All~     patients will have kidney biopsy at implantation and at 12 months after transplantation.~     Main outcome will be 1-year change in chronic kidney histology (interstitial fibrosis)~     assessed by protocol biopsy.~   "
91453|NCT01860170|"~     The purpose of this study is to determine if Bortezomib, known commercially as Velcade is~     safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be~     used as graft versus host disease prevention after reduced-intensity allogeneic~     hematopoietic stem cell transplantation.~   "
91454|NCT01860157|"~     In this study, the investigators will be examining the effects of the deep repetitive~     transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60~     who have been unable to tolerate or failed to respond to antidepressant medications. The~     coil was designed to stimulate deeper regions of the left DLPFC. The investigators propose~     that active stimulation with the H1 coil will result in higher remission rates than placebo~     stimulation but will have a similar tolerability and safety profile.~   "
91455|NCT01860144|"~     This observational, multicenter, prospective study will evaluate the use of bevacizumab in~     real clinical practice in chinese patients with metastatic colorectal cancer.~   "
91470|NCT01859936|"~     The study is a prospective randomised multicenter trial assessing the additional value of~     breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will~     preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the~     number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies?~     Will preoperative breast MRI be cost effective?~   "
91471|NCT01859923|"~     The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and~     efficacy of long-term (6-month) treatment with delamanid plus an optimized background~     regimen of other anti-tuberculosis drugs in pediatric patients who completed Trial~     242-12-232.~   "
91472|NCT01859910|"~     To investigate whether compression of the lid margin increase microbial contamination risk~     of patients undergoing cataract surgery~   "
91456|NCT01860131|"~     Extreme obesity is present in 9% of the Canadian population. Extremely obese people have a~     high chance of developing health problems and dying early. Our national guidelines recommend~     that extremely obese individuals receive multidisciplinary treatment, meaning that a number~     of specialized care providers should be available to help administer obesity treatments to~     these patients.~      The investigators oversee a large obesity program called the Weight Wise Obesity Program,~     which delivers multidisciplinary care at 5 sites in Alberta, Canada (Edmonton, Calgary,~     Grand Prairie, Medicine Hat, Red Deer). Wait times to enter the Weight Wise clinics range~     from a few months to three years depending on the site in Alberta. The investigators~     performed a survey of the patients on the wait list in Edmonton and discovered that they~     self- report extremely poor health and feel that the long wait times are partly responsible~     for this poor health. To try to support these patients as they wait for multidisciplinary~     care, the investigators designed a group based self-management intervention, consisting of~     Weight Wise Community Modules. Patients attend this program over three months to receive~     weight management education (diet, exercise, stress management, coping strategies).A~     web-based version of the modules is also available.~      The investigators wish to determine if these modules delivered to patients prior to entering~     the clinic help to reduce weight, improve quality of life in the wait listed patients and~     also to see if going through the modules helps patients to be more ready for weight~     management when they reach the Weight Wise clinic. The investigators also wish to examine~     whether or not these modules are cost effective. If these modules are not useful, a more~     effective way to support wait listed patients will be sought.~   "
91457|NCT01860118|"~     This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's~     disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients~     versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are~     significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase~     inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target~     effects for future LRRK2 inhibitor clinical trials.~   "
91458|NCT01860105|"~     Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs),~     this study, to be conducted in approximately 36 NHVs, will provide pertinent information in~     determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12~     receptor inhibition effects and in selection of doses that match the antiplatelet effects of~     300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK),~     safety and tolerability of single doses of MDCO-157.~   "
91459|NCT01860092|"~     This post-approval study is being implemented to monitor the use of Argus II System in a~     larger US population than available within pre-approval studies. An attempt will be made to~     include all eligible and willing subjects implanted with Argus II System in the United~     States.~      Safety data will be monitored to ensure continued acceptability of risks to study subjects.~     The utility (i.e. visual function and functional vision) and reliability of Argus II System~     will also be evaluated.~      There is no study hypothesis.~   "
91460|NCT01860079|"~     -  When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and~          at a high-volume centre, it is the optimal approach for ST elevation myocardial~          infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no~          clear definition for when to discharge and which patient to discharge.~        -  An early discharge strategy may be desired by all parties (financial health care~          provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.~        -  The main goal in our study is to test the hypothesis that an early discharge strategy~          within 48-56 hours in patients with successful PPCI is as safe as in those patients who~          stay longer (96-120 hours) as of a standard procedure.~   "
91461|NCT01860066|"~     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in~     patients with moderate to severe airflow limitation.~   "
91462|NCT01860053|"~     The purpose of this study is to reduce problematic vomiting and associated gastrointestinal~     symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention~     will yield greater reductions in vomiting and associated symptoms compared to our control~     condition.~   "
91463|NCT01860040|"~     To determine the rate of pathologic complete responses (pCR) at the time of definitive~     surgical resection of non-small cell lung cancer (NSCLC)~   "
91464|NCT01860027|"~     The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined.~     Some optometrists use observational eye movement tests as screening devices for dyslexia and~     advocate eye movement therapy as a treatment option for dyslexia. The reliability of the~     clinical eye movement tests and the efficacy of the eye movement therapies have not been~     determined.~      Saccades are the fast eye movements that move our eyes from one word to the next when we~     read. The eye movement recordings from patients diagnosed with reading disorders, extra~     ocular muscle imbalances and control patients (no learning disability or eye movement~     disorder) will be analyzed and compared. The sensitivity and specificity of detecting~     reading disorders will be determined for the Visagraph III and the Readalyzer. Although~     these clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose~     dyslexia in school aged children, the validity of these clinical screening tests has not~     been determined.~   "
91465|NCT01860014|"~     The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs~     mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who~     often have a PDA and have received surfactant. Although not clear, the cause of PH is~     thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to~     right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow.~     Prospective uncontrolled studies that used surfactant for PH in neonates have shown~     promising results in treating PH.In this study we aimed to evaluate the effect of two~     different natural surfactants in neonates with pulmonary hemorrhage.~   "
91466|NCT01860001|"~     The aim of this study is to define the incidence and nature of acidosis after major surgery~     using Figge's equations to directly measure acidosis. This study will also aim to compare~     the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate)~     to identify the presence of tissue acids in this population. The incidence of postoperative~     ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point~     of care urinalysis.~   "
91474|NCT01859884|"~     The objective of this study is to evaluate kidney transplant candidates' comprehension about~     increased risk donor kidneys necessary for informed consent. We have developed a web-based~     tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to~     current informed consent processes. We will then compare the effectiveness of the current~     informed consent processes supplemented by Inform Me, with the current consent processes~     alone for kidney transplant.~   "
91475|NCT01859871|"~     The purpose of this study is to increase understanding about living kidney donation (LKD)~     among Hispanic/Latino patients and public by increasing knowledge and positive attitudes~     about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients~     and public are fully informed of the treatment options for End Stage Kidney Disease.~   "
91476|NCT01859858|"~     Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties~     in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th~     most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin~     during their treatment for cancer because of the purported health benefits.~      This research study is designed to learn more about the safety, pharmacokinetics and~     effectiveness of irinotecan when given in combination with curcumin in patients with~     metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates~     drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better~     understand the interaction between curcumin and irinotecan by measuring levels of irinotecan~     in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information~     collected from this study could result in improved dosing guidelines and lead to more~     effective treatment of your cancer with less toxicity.~   "
91477|NCT01859845|"~     The specific aim of this study is to determine if interactive touchscreen-based learning~     with deliberate practice modules can enhance the retention of life-saving medical skills~     when incorporated into medical training curricula. We will analyze the retention and~     confidence of screening skills by comparing outcomes on pretest and posttest in each arm.~   "
91478|NCT01859832|"~     Patients undergoing renal transplantation at London Health Sciences Centre, University~     Hospital and who are participating in the study A Comparison of Effects of Standard Dose vs~     Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without~     ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune~     Response will be evaluated with the ImmuKnow Assay to assess the ability of this assay to~     predict underimmunosuppression (rejection) or overimmunosuppression determined by this test~     and to determine retrospectively whether decision making utilizing this novel assay would~     have improved outcomes over standard techniques.~      This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the~     measurement of cell-mediated immune response in renal transplant patients receiving~     immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells~     to stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the~     immune system of the patient at any point in therapy. The natural history of the immune~     status of the renal transplant recipient as reflected by the ImmuKnow assay will be~     determined at specific time points of interest including: pre and post transplant, as an~     adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode.~     Analysis of the results of the assay at these time points will allow us to retrospectively~     study the effects of routine immunosuppressive agent modulation on immune function, and its~     subsequent effects in times of renal allograft insult.~   "
91479|NCT01859819|"~     To safely reduce the burden of therapy in children, adolescents and young adults with mature~     B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT~     Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline~     (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy~     backbone (Immunochemotherapy).~   "
91480|NCT01859806|"~     Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary~     tumour (benign or malignant). In the recent years, the mortality rate of PD has decreased to~     5% in many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of~     patients after PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic~     drainage decrease the incidence of PF and severity with preservation of pancreatic function.~      So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus~     Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional~     outcome.~   "
91481|NCT01859793|"~     The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4~     inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2~     diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this~     double blinded cross over study where they will receive a sitagliptin pill once a day for 8~     weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods~     are divided by a 4 week period. Blood vessel function will be measured by ultrasound before~     and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment~     with each. Blood will also be taken to measure blood markers of inflammation at each time~     the ultrasounds are performed.~   "
91482|NCT01859780|"~     Unintentional poisonings of children continues to be a major issue in the US. According to a~     study conducted by Cincinnati Children's Hospital Medical Centers, during the period from~     2001-2008, emergency room visits for children less than 5 rose 28% as the result of~     pharmaceutical products. The authors note, the problem of pediatric medication poisoning is~     getting worse, not better.~      Child resistant closures have been required on most medications sold in the US since the~     early 1970s. However, most designs attempt to thwart children through purely physical means~     (e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any~     designs, have utilized perception and cognition as a way to enhance child resistance.~      The investigators propose utilizing visual illusions in spaces distinct from the opening~     mechanism of prescription packages as a means of enhancing child resistance. In this~     project, visual illusion images are applied to both vials and wallet blisters in order to~     attract children's interest and prolong the time before opening.~      During Stage I, the investigators will determine if the visual distractor attracts attention~     when samples are displayed in a storage rack. During Stage II, the investigators will test~     the effect of visual distractors on child resistance as measured by successful openings and~     time to open.~   "
91483|NCT01859767|"~     This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD~     patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of~     MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to~     detect ß amyloid deposition in the brain of AD research participants and young healthy male~     subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New~     Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to~     participate in this study. HVs will be screened to ensure that there is no evidence of~     cognitive decline or significant neurological deficit.~      All eligible subjects will be required to visit the study center on at least 2 occasions:~        1. for one or more screening visits which should include a history and physical~          examination, laboratory and extensive neuro-psychological testing and MRI brain~          scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening~          Visit.~        2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT~          scanning- followed by safety measures~   "
91484|NCT01859754|"~     Study Design:~      This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug~     reactions between Octagam 5% and other marketed IVIG infusion treatments.~   "
91485|NCT01859741|"~     The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in~     combination with EP for 6 cycles followed a Phase 2, multicenter, randomized,~     placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with~     EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in~     subjects receiving first-line therapy for extensive stage small cell lung cancer.~   "
91486|NCT01859728|"~     To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the~     treatment of biliary tract cancer.~   "
91487|NCT01859715|"~     This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of~     oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.~   "
91488|NCT01859702|"~     The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing~     with a combination drug Vigadexa preoperatively in cataract patients.~   "
91489|NCT01859689|"~     This phase II trial studies how well internal radiation therapy works in treating patients~     with low-risk prostate cancer. Internal radiation uses radioactive material placed directly~     into or near a tumor to kill tumor cells.~   "
91490|NCT01859663|"~     The purpose of the study is to identify lifestyle factors associated with PCOS and~     understand how diet and activity levels impact features of PCOS. The secondary aim is to~     examine psychosocial factors (e.g., health beliefs) of women with PCOS.~   "
91491|NCT01859650|"~     The University of Sheffield is one of the leading centres in the world for basic and~     translational research with inhaled gas MRI, which provides lung images with unprecedented~     spatial and temporal resolution. Our previous work demonstrated that inhaled gas MRI can~     provide significant clinical information for lung cancer radiotherapy planning and~     post-treatment evaluation. Building upon this unique experience, a multidisciplinary team~     will conduct an inhaled gas and proton lung MRI study that will address two of the major~     clinical problems faced by lung cancer patients treated with radiotherapy.~        1. Normal lung tissue is often damaged by the curative radiation dose. The investigators~          hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas~          and proton MRI before and after treatment will help to lower the risk of~          radiation-induced lung injury and help to detect such damage at an early stage.~        2. Identification of the extent of cancerous tissue is error-prone when planning treatment~          from CT images alone. The investigators hypothesise that advanced proton MRI techniques~          will improve the identification of tumour volume, which is critical to successfully~          targeting the radiation dose.~      To achieve these goals, image acquisition and image processing methods will be tested with a~     study of 20 patients. Results from this study will make an important contribution to~     improving the treatment of lung disease which is one of the key research priorities of the~     NHS.~   "
91492|NCT01859637|"~     Purpose of the study is to investigate the safety, immunogenicity and the efficacy of~     Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed~     with severe chronic neutropenia.~   "
91493|NCT01859624|"~     Albuterol is a drug approved by the US Food and Drug Administration (FDA) for treating~     breathing problems such as asthma. Studies have shown that albuterol may be beneficial in~     improving muscle function in people with late-onset Pompe disease. The purpose of this study~     is to evaluate whether albuterol is safe and effective for improving muscle function in~     people with late-onset Pompe disease, whether or not they are receiving enzyme replacement~     therapy (ERT). For this study, albuterol is considered an investigational drug. The word~     investigational means albuterol is not approved by the FDA for individuals with late-onset~     Pompe disease.~   "
91494|NCT01859611|"~     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,~     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple~     treatments. The primary endpoint is observation of changes to the surface by visual and~     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort~     of the treatment and the measurement of adverse events.~   "
91495|NCT01859598|"~     The scientific use of basal insulin is of great help to individuals and the government.~     However, there are few studies to investigate the real world use, effect, safety and~     influence factors of basal insulin in China. This study is to evaluate the use of first~     basal insulin in China patients with type 2 diabetes with inadequate glycemic control on~     oral antidiabetic agents (OADs) from the naturalistic clinical practice.~   "
91496|NCT01859585|"~     The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a~     preemptive analgesia in patients undergoing lumbar spinal fusion.~   "
91497|NCT01859572|"~     The rationale for this study is to facilitate future Phase II/III clinical trials and~     improve outcome for patients suffering residual disability after an ischaemic stroke. Main~     study objectives are to document and better define the prognostic characteristics of~     residual disability in patients following an ischaemic stroke, to inform the design of small~     efficient Phase II studies when screening potentially efficacious interventions for signals~     of activity which merit further development and to establish a pool of patients who may be~     approached to participate in future clinical trials in the ischaemic stroke setting.~   "
91498|NCT01859559|"~     The primary objective of this randomized controlled trial (RCT) is to compare the success~     rate of obtaining peripheral vascular access with ultrasound guidance versus the~     traditional, landmark approach among patients with varying degrees of intravenous access~     difficulty. In addition to comparing overall initial success rates of the two methods, we~     will also compare the success rates by degree of intravenous access difficulty (3 main~     subject subgroups) and by operator experience (approximately 20 emergency department~     technicians).~      The main hypothesis is that the initial success rate will be significantly higher (5% or~     greater) for ultrasound guided peripheral intravenous access compared to landmark approach~     among patients who are judged to have difficult intravenous access but no significant~     difference (i.e. < 5%) among patients judged to have easy intravenous access.~   "
91499|NCT01859546|"~     Vaccines are one of the best public health tools available to achieve the Millennium~     Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood~     vaccine coverage is the lack of awareness among parents regarding the need for immunization~     in children, and the importance of completing the entire series of vaccines. This result in~     significant drop-out between vaccines delivered at birth and later in the infancy period.~     New innovative methods involving technologies are needed to be employed to increase the~     vaccine coverage. This study is being conducted in Karachi, Pakistan and main study~     objective is~      • To assess the effectiveness of SMS reminders on cell phones in improving the compliance of~     subsequent visits for routine immunization for children.~   "
91500|NCT01859533|"~     Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via~     Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the~     duration and complication of TTN.~   "
91501|NCT01859520|"~     Sperms are prepared by sperm washing techniques before used in assisted reproductive~     technologies. Most commonly used sperm preparation methods are the swim up and the density~     gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related~     to the success in assisted reproduction techniques. Sperm preparation methods may~     theoretically cause damage to sperm DNA. Therefore it is important to select the optimum~     method of sperm preparation causing least sperm DNA damage. Aim of our study is to~     investigate and compare the effect two different sperm preparation techniques on DNA~     fragmentation.~   "
91502|NCT01859507|"~     During the first visit, the couple will be acquainted with their condition. This will~     include the epidemiology of their condition, some sex education tips, as well as the~     therapeutic modalities available. This is followed by short description of the protocol. In~     the procedure room, each patient will be examined to determine the degree of vaginismus and~     classify her condition according to Lemont's classification as modified by Pacik, from 1 to~     5. In the same or subsequent sessions, surface anesthesia of the area of injection followed~     by ice packs is used before the BOTOX is injected into the muscle.~   "
91503|NCT01859494|"~     The purpose of this study was to determine if untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
91504|NCT01859481|"~     Evaluation of headache response at 2 hours for active treated attacks for increasing dose.~   "
91505|NCT01859468|"~     Amorphical has a strong basis to believe that the Amorphous Calcium Carbonate (ACC) product~     has an effect on active mineralization during bone remodelling hence, it has a potential to~     accelerate fracture healing process. The active mineralization can most probably be~     attributed to the mineral component of this substance.~      The distal radius fracture was chosen as the model to test the effects of ACC treatment~     because it includes both trabecular and cortical bone, is accessible for radiographs, has~     little soft tissue that can distort the radiograph, and is amenable to multiple functional~     endpoints.~      Primary objective:~      To assess the efficacy of treatment with calcium from ACC compared to placebo on~     radiographic healing time in subjects with distal radius fractures.~      Secondary objectives:~        -  To evaluate the effect of ACC compared to placebo on the improvement in wrist~          functional outcome following distal radius fracture.~        -  To evaluate the safety profile of ACC in this population~   "
91506|NCT01859455|"~     This study is designed to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications~     and in healthy volunteers.~   "
91507|NCT01859442|"~     The present study is a randomised control trial investigating the effects of a short six~     week exercise training program in rectal cancer patients following neoadjuvant~     chemoradiotherapy prior to elective rectal cancer surgery.~      Twelve patients will be randomised (1:1) to an intervention and a control group. The~     patients randomized to the intervention group will attend a total of 18 tailored exercise~     sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy~     treatment. Where possible the exercise training sessions will be arranged to fit in with~     other appointments at the hospital. Patients randomized to the control group will be~     unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test~     and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health~     related quality of life interviews at week 0, 3 and 6 during their exercise programme. These~     appointments will be directly before or after their exercise sessions to minimise hospital~     attendence.~      Following surgery only routine clinically relevant observational data will be collected.~     These data will relate to hospital length of stay, the level of care required following~     surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this~     information can be accessed from patient notes and on the electronic patient records system.~      This is a subgroup RCT of patients in a larger interventional trial (6 control and 6~     exercise intervention patients) will be asked to consent separately for the the~     31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.~      HYPOTHESIS~        1. Interval exercise training will maintain or improve fitness (measured by anaerobic~          threshold) in patients undergoing neoadjuvant chemoradiotherapy.~        2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant~          chemoradiotherapy awaiting rectal cancer resection.~        3. Interval exercise training will improve other measures of physical fitness measured in~          the CPET and the oxygen uptake kinetics test.~        4. Interval exercise training will improve quality of life in patients undergoing~          neoadjuvant chemoradiotherapy.~        5. Improvements in physical fitness will reduce postoperative complications following~          major rectal cancer surgery.~        6. Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during~          neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise~          training program?~        7. Can we find an optimal time for surgery when fitness and cancer downstaging are at~          their best?~      HYPOTHESIS for Mechanism Pilot Study~        1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.~        2. To explore the alteration in cellular and mitochondrial energetics eg. Change in~          mitochondrial numbers, change in mitochondrial activity and respiration.~   "
91554|NCT01858818|"~     This project aims to investigate how dysfunctional learning and habitization are affected by~     acute alcohol exposure, and whether individual differences in such alcohol effects can~     predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male~     subjects are tested on two days in a within-subjects design with blinded administration of~     alcohol vs. placebo and different behavioral and learning tasks. The investigators~     investigate how alcohol influences the performance during these tasks, whether alcohol~     effects differ between high- and low-risk subjects, and whether task performance under~     alcohol predicts future AUDs.~   "
91508|NCT01859429|"~     The study will examine whether the provision of psychosocial support services for cancer~     patients in acute care can be optimized by the use of a structured combination of screening~     procedures with physician interviews and structured patient pathways.~      There is strong evidence that a third of all cancer patients in acute care are suffering~     from mental health conditions and that a third expresses the need for professional~     psycho-oncological support.~      However, physicians and nurses do not always identify these patients in need for support.~     Screening questionnaires are significantly better to identify distressed patients however~     the use of screenings alone does not necessarily improve the patients' emotional well-being.~      Purpose of this study is to evaluate a psychosocial stepped care model which aims to~     decrease the patients' distress.~   "
91509|NCT01859416|"~     Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition~     in older persons, evidence from nursing home populations including demented residents is~     rare, especially with regard to functionality and well-being. A known barrier for ONS use~     among older persons is the volume that needs to be consumed, resulting in low compliance and~     thus reduced effectiveness.~      Thus, this study aimed to investigate the effects of a new, low volume, energy- and~     nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home~     residents with malnutrition or at risk of malnutrition.~      In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed~     to identify all residents with malnutrition or at risk of malnutrition who might possibly~     benefit from nutritional intervention. All subjects with either a Mini Nutritional~     Assessment (MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the~     nurses' perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively,~     were invited to participate and asked for informed consent.~      Eligible residents with informed consent were randomly assigned to the intervention group~     (IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual~     nutritional care or to the control group (CG) which received usual nutritional care only.~      Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference~     and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily~     living, handgrip strength, gait speed and quality of life were examined using standardized~     instruments and protocols. All measurements and tests were performed at baseline, after 12~     and 24 weeks.~      Compliance and tolerance were documented daily by nursing staff and regularly controlled by~     the study team.~      Statistical analysis was performed following the intention-to-treat (ITT) approach including~     all residents originally assigned to either the IG or CG unless residents died during the~     study. A sample size calculation was performed with body weight as the primary outcome~     parameter (0.8 power to detect a significant difference p<0.05, two-sided) based on an~     estimated mean body weight 55 kg and a mean difference in body weight between the groups~     after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population.~     To detect a significant difference between IG and CG, 35 subjects were needed for each~     group. While sample size calculation aimed at ensuring adequate power to detect meaningful~     differences, the actual statistical analysis was of exploratory nature.~   "
91510|NCT01859403|"~     This study aims to determine if providing genomic information to veterans can help them lose~     weight compared to usual care.~   "
91511|NCT01859390|"~     The purpose of this study will be to evaluate the effects of a modified formulation of~     AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress.~      Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs.~     Some of the damage to the lungs of CF patients may be caused by something called~     oxidant/antioxidant imbalance and oxidative stress.~      Oxidation in the body is kind of what happens to an apple when it turns brown after being~     cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can~     stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free~     radicals. Free radicals can help fight off bacteria and viruses but too many of them do~     damage instead. Our bodies need antioxidants to keep things in balance so we have the right~     amount of free radicals.~      Many CF patients also have trouble digesting food and absorbing nutrients like vitamins.~     Many of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and~     beta-carotene. In some people with CF, even though they take multivitamins and pancreatic~     enzymes, they still have low amounts of antioxidants. We are looking to see if taking more~     vitamins and antioxidants will help CF patients.~      AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food~     and Drug Administration [FDA]). This research study is being done with the AquADEKs-2~     compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of~     fat-soluble vitamins (A, D, E, K)that are contained in typical CF multivitamin supplements~     plus several antioxidants including beta-carotene, mixed tocopherols (different forms of~     vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and~     the minerals zinc and selenium. The control multivitamin contains standard amounts of~     vitamins A, B, D, E, and K without additional antioxidant supplementation.~   "
91512|NCT01859377|"~     The purpose of this study is to evaluate the systemic exposure to ibuprofen after single~     oromucosal administration of the test product V0498 and single oral administration of a~     reference product.~   "
91513|NCT01859364|"~     Background:~      - The success rate for those who attempt to quit using tobacco products is only about 5~     percent. Many people who try to quit do so without seeking professional help. Several kinds~     of nicotine replacement therapy (NRT) are available without a prescription. However,~     prescription drugs and mental health counseling can also help people stop using tobacco.~     Combining NRT and/or medication with counseling can increase success rates. Researchers want~     to study what kinds of tobacco cessation treatments are most successful. This may help~     develop better treatments and determine who will respond best to them.~      Objectives:~        -  To provide treatment for tobacco use.~        -  To identify factors that affect how well people respond to treatment.~      Eligibility:~      - Individuals at least 18 years of age who are trying to stop using tobacco products.~      Design:~        -  This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may~          include counseling, NRT (patches and/or nicotine lozenges), or prescription medication~          (varenicline or bupropion). Treatment will be determined by a study doctor.~        -  Participants will also have three study visits at 4, 6, and 12 months after starting~          treatment. Each visit may take up to 2 hours. At the study visits, participants will~          have different kinds of tests. They will provide blood and urine samples, and have~          carbon monoxide breath tests. They will also fill out forms about mood and tobacco~          cravings.~        -  During treatment, participants will have clinic visits once or twice a week for~          counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will~          work on dealing with tobacco cravings. Each visit may take up to 90 minutes.~   "
91514|NCT01859351|"~     The purpose of this study is to test the safety of escalating doses of the novel PI3K~     inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets~     mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these~     two novel compounds could provide targeted inhibition of both pathways to block tumour~     growth.~   "
91515|NCT01859338|"~     This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography~     (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer~     undergoing radiation therapy. Comparing results of diagnostic procedures done before and~     during radiation therapy may help doctors predict a patient's response to treatment and help~     plan the best treatment.~   "
91555|NCT01858805|"~     Despite the availability of several preoperative diagnostic techniques, accurate~     pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The~     investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in~     patients with EC.~   "
91516|NCT01859325|"~     Background:~      - In most people who have human immunodeficiency virus (HIV), the immune system cannot~     control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus~     low for a long time. However, this treatment does not remove the virus from the body. In the~     vast majority of patients antiretroviral therapy also will not protect the body from the~     virus once treatment stops. Researchers want to see if therapeutic vaccination can help~     people with HIV. Therapeutic vaccination means giving vaccines to treat an infection that~     someone already has (HIV, in this case). It may help the body's immune system attack the~     infection. This study will look at different measures of HIV infection after receiving~     either therapeutic vaccination or a placebo.~      Objectives:~      - To see whether therapeutic vaccination is safe and can affect how the body responds to HIV~     infection.~      Eligibility:~      - Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral~     therapy drugs.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  During the screening visit and throughout the study until week 56, participants will~          continue to take their HIV medications.~        -  Participants will be divided into two groups. One group will have the study vaccines.~          The other will have a placebo.~        -  The first study vaccine or placebo will be given in weeks 4, 12, and 36. The second~          study vaccine or the placebo will be given in weeks 24 and 48. Blood samples and other~          tests will be given at each visit.~        -  After the study visit at week 56, participants will stop their HIV medications until~          week 72. From weeks 58 through 72, they will come in every 2 weeks for study visits;~          each visit will take about 1 hour to complete. These visits will look at the body s~          response to the vaccines and their HIV viral load. After week 72, participants will~          re-start their HIV medications.~        -  There will be follow-up study visits from weeks 76 to 96, with blood tests and other~          studies.~   "
91517|NCT01859312|"~     Background:~        -  Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The~          adrenal gland is located in the abdomen and produces small amounts of hormones such as~          cortisol, aldosterone, and androgen. These hormones help control blood pressure,~          protect the body, and maintain good health, especially during development. People with~          CAH do not make enough cortisol and aldosterone, and make too much androgen. This can~          lead to serious medical problems. The standard treatment is to take pills that mimic~          the effects of cortisol and aldosterone. However, treatment with pills can have~          long-term side effects because of the higher doses needed, and may not work well for~          some people.~        -  A possible new treatment for CAH is to use a pump to deliver cortisol under the skin.~          Similar pumps are often used to give insulin to people with diabetes. Researchers think~          that a cortisol pump might be able to help the body use the cortisol more effectively~          than taking pills. They want to compare the results of a cortisol pump and standard~          pill treatments for CAH.~      Objectives:~      - To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for~     CAH.~      Eligibility:~      - Men and women at least 18 years of age who have CAH (see more details in Eligibility~     section below).~      Design:~        -  This study will involve four inpatient hospital stays at the National Institutes of~          Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays~          will last about 5 days. The second and third stays will last about 3 days.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  At the first study visit, participants will provide regular blood and urine samples.~          They will also have imaging studies. These studies will look at the bones, fat, and~          muscles in the abdomen and pelvis.~        -  Participants will receive a cortisol pump during the first visit. They will be shown~          how to use the pump. They will also learn what to do, if they need to take extra~          stress dose cortisol pills.~        -  At the second and third visits, the cortisol dose given with the pump will be adjusted~          as needed. Blood and urine samples will also be collected. No imaging studies are~          scheduled for these visits.~        -  The last study visit will have the same tests as the first visit. Participants will be~          offered the chance to continue with the pump treatment for 1 more year, or go back to~          their standard pill treatment.~      Study type: Interventional non-randomized trial~      Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone~     Infusion In the Treatment of Congenital Adrenal Hyperplasia~      Estimated enrollment: 8~      Study Start Date: May 2013~      Estimated Study Completion Date: December 2016~      Sponsoring Institute: National Institute of Child Health and Human Development~      <TAB>ELIGIBILITY~      Inclusion criteria~        1. Men and women 18 years of age or older with classic congenital adrenal hyperplasia~          (21-Hydroxylase deficiency)~        2. High adrenal androgens in the blood, and~        3. One or more of the following conditions: obesity, fatty liver, risk for diabetes, low~          bone mass, inability to tolerate cortisol pills~      Exclusion criteria~        1. Pregnancy~        2. Breast feeding~        3. Use of inhaled or oral steroids for diseases other than CAH~        4. Use of estrogen-containing birth control pills~        5. Use of medicines that cross-react with hydrocortisone~        6. Use of stress dose steroids for illness during the last 30 days prior to joining the~          study~   "
91518|NCT01859299|"~     Background:~      - Uveitis and age-related macular degeneration (AMD) are two types of eye diseases related~     to inflammation in the eyes. However, the causes of these diseases are not fully understood.~     Researchers want to look at bacteria in the body that might be related to the inflammation.~     They will study the natural bacteria present in the gut and intestines of people with~     uveitis and AMD to learn what might trigger these diseases.~      Objectives:~      - To study the gut and intestinal bacteria in people with AMD and uveitis.~      Eligibility:~        -  Individuals at least 18 years of age who have quiet (non-inflamed) uveitis.~        -  Individuals at least 18 years of age who have active (inflamed) uveitis that requires~          additional treatment.~        -  Individuals at least 18 years of age who have uveitis or AMD and are having immune~          system therapy at the National Eye Institute.~      Design:~        -  Participants with quiet uveitis will have one study visit. Participants with active~          uveitis will have two study visits. The second visit will be 4 to 6 months after the~          first visit. Participants with uveitis or AMD who are having immune system therapy will~          have two visits. The first will be before the start of the therapy, and the second~          visit will be 4 to 6 months after starting the therapy.~        -  About 12 hours before each study visit, participants will give themselves an enema at~          home. This will clear out the lower intestine for specimen collection.~        -  At each visit, participants will have a full eye examination, including vision and eye~          pressure tests. They will provide blood samples for testing. They will also have an~          anoscopy to collect rectal fluid and study the colon lining.~        -  Treatment will not be provided as part of this study.~   "
91519|NCT01859286|"~     The investigators sought to determine if implementing a standardized sign out process would~     reduce the amount of medical errors related to patient sign out. The standardized process~     included the following interventions: implementation of a data resident to review patients~     lab values, vital signs, radiologist results, and orders in real time, conducting sign out~     in a standardized location and using the attending physician as an interruption manager.~     The investigators defined medical errors related to sign out as any piece of information was~     incorrectly reported or omitted during sign out that caused a change in treatment or~     disposition discussed during sign out. The investigators hypothesis was that implementing a~     standardized sign out process would lead to a decrease in the amount of sign out related~     errors.~   "
91520|NCT01859273|"~     Despite significant advances in the care of kidney transplant recipients, long term graft~     survival after renal transplantation remains suboptimal. Medication nonadherence and~     clinical inertia are key contributors to graft loss. The purpose of the proposed RCT~     feasibility study is to evaluate impact of a bundled wireless real time medication~     reminder system and blood pressure monitoring system in combination with a cognitive~     behavioral adherence skills enhancement program upon medication adherence, therapeutic drug~     concentration, and blood pressure, in nonadherent kidney transplant recipients with~     hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20~     non-adherent continuing to phase 2 for a 5-month feasibility RCT.~   "
91521|NCT01859260|"~     Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with~     chronic kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia~     due to OSA is associated with worsening kidney function. Hospitalized patients are often~     exposed to multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which~     place them at risk for acute worsening of kidney function. This study aims to determine~     whether immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence~     of acute kidney injury during hospitalization. The investigators will evaluate the extent to~     which this effect can be attributed to a decrease in nocturnal hypoxia and improved blood~     pressure control. Secondary endpoints include hospital length of stay, and a composite~     outcome comprised of hemodialysis initiation, major cardiovascular events, and mortality.~   "
91522|NCT01859247|"~     The overall objective of this application is to therapeutically target the dysfunctional~     premotor-motor interaction in dystonia—and to provide a focused treatment of specific~     anatomical networks in order to reduce side effects and to improve symptom control over~     conventional therapies.~   "
91523|NCT01859234|"~     The purpose of this study is to see whether 89Zr-bevacizumab PET scanning is feasible in~     relapsing multiple myeloma patients.~   "
91524|NCT01859221|"~     The purpose of this phase II study is to evaluate the outcomes of patients treated with an~     investigational radiation regimen using stereotactic radiotherapy for oligometastatic~     prostate cancer and to establish efficacy (producing a desired result or effect) and safety~     in this setting.~   "
91556|NCT01858792|"~     Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE)~     Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled~     Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies~   "
91587|NCT01858389|"~     This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each~     two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of~     patients, those whose tumor has a documented T790M mutation, and those without this~     mutation. All patients will receive repeated cycles of dacomitinib until disease~     progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.~   "
91525|NCT01859195|"~     The purpose of this project is to explore women's thoughts, opinions, and ideas about~     vaginal products. The investigators will ask women to help design the best strategy for~     applying a vaginal product using a specific kind of applicator. The investigators want to~     identify designs that women think would be easy to prepare and insert. Women's thoughts and~     opinions will help researchers develop new products called microbicides that may protect~     against HIV and other sexually transmitted diseases, that are easy to use, and that will be~     acceptable to women who use them. If researchers can make products that are easy to use and~     that women like to use, the products will be used more often, and more infections will be~     prevented.~      Women who enroll in the project will either participate in a focus group with approximately~     3-7 other women or a one-on-one cognitive interview. All participants will complete a brief~     questionnaire. Some women may enroll in both stages.~      Each focus group will take approximately 1.5-2.5 hours. Group leaders will talk to women~     about their experiences using vaginal products and will provide participants with study~     products to look at and touch. All participants will be asked to come up with ideas of how~     to make the products easy to use and acceptable to women who use them. Group leaders will~     encourage discussion about the different designs. After this, group leaders will talk about~     a specific type of microbicide and ask women about their opinions. In particular,~     researchers and participants will talk about the language that would be best understood by~     women who would use these products or be in studies to evaluate them.~      Each cognitive interview will take approximately 1.5-2.5 hours. Each participant will be~     asked about different product designs and application instructions, and will be asked her~     thoughts, opinions, and potential concerns about each. She will also evaluate sample~     language that will be used to help women understand the products and how to use them.~   "
91526|NCT01859182|"~     This phase II trial studies how well selumetinib and Akt inhibitor MK-2206 work in treating~     patients with refractory or advanced gallbladder or bile duct cancer that cannot be removed~     by surgery. Selumetinib and Akt inhibitor MK-2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
91527|NCT01859169|"~     This research is a prospective randomized controlled trial.It aimed to determine longterm~     outcomes and factors associated with increased survival after photodynamic therapy (PDT)~     through T-tube compared with biliary drainage alone in patients presenting with unresectable~     bile duct cancer.~   "
91528|NCT01859156|"~     The purpose of this study is to determine whether a relationship exists between EtCO2 and~     carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner~     relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.~   "
91529|NCT01859143|"~     This prospective annual release study is designed to evaluate the safety on new influenza~     virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza~     season.~   "
91530|NCT01859130|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona fixed bearing knee implants used in total knee~     arthroplasty. The assessment will include implant survivorship and clinical performance~     measured by pain and function, quality of life data, radiographic parameters and~     survivorship.~   "
91531|NCT01859117|"~     This clinical study is being conducted to assess the safety and determine the maximum~     tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower~     leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will~     look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer~     healing. This study will also help to find the best dose of PDA-002 to use in future~     studies.~   "
91532|NCT01859104|"~     This current study aims to evaluate the efficacy of engagement modules in assisting patients~     who are candidates for renal and liver transplantation make significant lifestyle~     modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android~     and iOS compatible) has been created to assist in both educating and engaging patients to~     develop and maintain healthy lifestyle modifications. Our goal is to create a~     cost-effective, smartphone-based platform that serves to not only efficiently educate but to~     also verify competence and keep our patients engaged.~   "
91533|NCT01859091|"~     The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for~     non-invasive reduction of submental fat.~   "
91534|NCT01859078|"~     The purpose of this study is to determine the effect of baricitinib on the levels of digoxin~     in the blood stream and how long it takes the body to remove digoxin. This study will also~     look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in~     healthy participants. This study will last approximately 3-4 weeks.~   "
91535|NCT01859065|"~     Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than~     14 days of age, revealed that half of all visits in this population were non-acute problems.~     Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all~     visits were for non-urgent problems.~      Many studies have found that primiparity and young maternal age are associated with~     non-acute ED presentations. A recent factor that has been investigated is the effect of~     early neonatal discharge. Some other factors are nonwhite mothers and mothers on Medicaid.~     Zandieh et al, found additional predisposing determinants for non-urgent ED visits, such as~     single parenthood, Hispanic ethnicity, and having perceptions that their child's overall~     physical health was poor.~      Paradis et al found that parents receiving a video intervention rated higher confidence with~     specific infant care skills and reported feeling better prepared to care for their baby,~     compared to parents receiving only handouts. However, there isn't any reported study that~     evaluates the benefits of receiving both, a video intervention along with handouts.~      Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems~     will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance~     (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about~     jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel~     movement, fever).~   "
91536|NCT01859052|"~     The purpose of this study is to look at two different diets (a low carbohydrate diet and a~     low fat diet) for migraine prevention in overweight or obese persons with migraine. The~     overall aim is to test the theory that diet will improve migraine frequency and that such~     improvements will be associated with favorable changes in body weight, inflammation, and~     heart health.~   "
91566|NCT01858662|"~     To analyze the pathological tumor response on resected colorectal cancer metastases after~     preoperative treatment with cetuximab combined with FOLFOX or FOLFIRI regimen in a~     prospective cohort (RAS and B-RAF WT tumors) and to correlate this response with patient's~     outcome.~   "
91567|NCT01858649|"~     The study is designed to analyze the pathological tumor response on resected colorectal~     cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or~     FOLFIRI regimen in a prospective cohort and to correlate this response with patient's~     outcome.~   "
91568|NCT01858636|"~     To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen~     through the collection of device/procedure-related major vascular complications and time to~     hemostasis.~   "
91537|NCT01859039|"~     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.~     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.~     There is robust data to support the safety of influenza vaccines (containing low or~     negligible amounts of egg protein) in patients with egg allergy.~      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently~     been approved by a number of licensing boards and is given by a spray into the nose. This~     new vaccine has been available in the United States for several years and is highly~     effective and against influenza infection, with an excellent safety profile in children~     without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and~     there are NO existing data on the safety of LAIV in egg-allergic children.~      The objective of this multicentre study is to assess the safety of intranasal LAIV in~     egg-allergic children, in order to demonstrate that these children can safely be given the~     new LAIV within a primary care health environment.~   "
91538|NCT01859026|"~     The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva)~     given in combination are safe and have beneficial effects in patients who have NSCLC.~      The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC.~     Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.~   "
91539|NCT01859013|"~     The prevalence of severe pediatric obesity is on the rise and youth with this condition are~     at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and~     type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug~     Administration (FDA) for the treatment of seizures in adults and children, is associated~     with weight loss. Although not FDA approved for the treatment of obesity, studies in obese~     adults have demonstrated weight reduction of approximately 5% with 6-12 months of therapy.~     However, the weight loss effect of topiramate has never been evaluated among children and~     adolescents. Therefore, the goal of this pilot study is to evaluate the safety and efficacy~     of 24 weeks of topiramate therapy with a 4-week run-in of meal replacement therapy in~     adolescents with severe obesity. The primary hypothesis is that 4 weeks of meal replacement~     therapy followed by 24 weeks of topiramate will have a larger average percent decline in BMI~     between baseline and 28 weeks compared to meal replacement therapy followed by placebo.~   "
91540|NCT01859000|"~     This protocol seizes this rare scientific opportunity to test an integrative family based~     model to address youths' coexisting substance abuse and trauma in the wake of Hurricane~     Katrina. The study would address a number of gaps in the current evidence base related to~     understanding and treating comorbid teen drug abuse and trauma that may be initiated or~     exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two~     promising interventions for youth with comorbid trauma and substance abuse, family-based~     treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital~     information about effective treatment for substance abusing youth following traumatic~     events.~   "
91541|NCT01858987|"~     The optimal technique of parenchymal transection in liver surgery has remained a matter of~     controversial debate among hepatobiliary surgeons. The optimal technique should enable~     secure sealing of the vascular and biliary structures that results in low intraoperative~     blood loss as well as low postoperative complication rates. Although numerous devices have~     been introduced and are used widely, high-level evidence, randomized controlled trials, that~     evaluate efficacy and safety of these devices are scarce. In the present randomized~     controlled trial two techniques of hepatic resection using vascular staplers and the~     LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative~     blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and~     safety of both methods.~   "
91542|NCT01858974|"~     With this study the investigators want to determine, if a fast identification of germs,~     causing infections of the lower respiratory tract, is possible through the use of Multiplex~     PCR technology - a method that allows on time detection of bacteria in medical specimen by~     identifying DNA sequences that are known to be specific for the respective microbe.~     Therefore aspiration samples from the respiratory tracts of ventilated patients, which are~     suspected to develop such an infection, will be collected and analyzed by using a multiplex~     PCR (polymerase chain reaction) application situated on the intensive care unit. The~     investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to~     conventional microbiological methods. The results of the Multiplex PCR analyses therefore~     will be compared with results of conventional microbiological methods.~   "
91543|NCT01858961|"~     The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI~     207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based~     regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients,~     including patients with compensated cirrhosis.~   "
91544|NCT01858948|"~     The investigators will test the hypothesis that the adverse effects of second-generation~     antipsychotics exposure and the beneficial effects of long-chain omega-3 (LCn-3) fatty acids~     are mediated by opposing effects on the enzyme implicated in the metabolic syndrome and~     obesity.~   "
91545|NCT01858935|"~     This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in~     normal, healthy, subjects~   "
91569|NCT01858623|"~     This study was conducted to investigate any potential reaction between losartan and~     hydrochlorothiazide.~   "
91570|NCT01858610|"~     This study was conducted to investigate any potential reaction between irbesartan and~     hydrochlorothiazide.~   "
91588|NCT01858376|"~     The hypothesis of this study is that the natural supplement Capros will decrease LDL levels,~     platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in~     humans at risk for cardiovascular disease.~   "
91589|NCT01858363|"~     This is a prospective, randomized, multi-center, single-blind study to demonstrate the~     safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty~     (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo~     occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and~     popliteal arteries.~   "
91610|NCT01858090|"~     In this prospective, randomized, double-blind, controlled study, the aim was to compare the~     effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml~     0.5%) on the intraoperative anesthesia quality, block characteristics, the side effects on~     the newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction~     score.~   "
91546|NCT01858922|"~     Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system.~     The lymph system is made up of tissue throughout the body that makes and stores~     infection-fighting cells. HD is one of the most treatable childhood cancers. The standard~     treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation~     therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured~     from their cancer, some patients experience negative side effects from treatment later in~     life. These kinds of side effects are often referred to as late effects. This can include~     problems with growth, problems with some organ functions, and sometimes second cancers.~     These types of effects can be associated with either chemotherapy or radiation therapy. The~     investigators are therefore designing studies to minimize or prevent these late effects. It~     is thought that if some patients can be successfully treated without radiation, those~     patients might experience fewer late side effects.~      Some patients, however, do not respond as well to the first stages of treatment (slow early~     responders). Slow early responders are considered to be at higher risk for relapse. This~     study also looks at whether these kinds of patients will benefit from additional~     chemotherapy.~      The purpose of this study is to look at how the immune system recovers and at how certain~     T-cells in the blood behave after receiving chemotherapy with or without radiation. The~     investigators also want to identify if bio-markers (special proteins in blood and in cancer)~     relate to the response of HD to study treatment.~   "
91547|NCT01858909|"~     OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with~     severe sepsis and septic shock.~      Specifically:~        1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with~          vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution~          towards the failure of other organs.~        2. To evaluate, waiting for reduction under the influence of the treatment with melatonin,~          :~             1. clinical - analytical parameters of sepsis;~             2. levels of cytokines;~             3. oxidative and nitrosative stress;~             4. acute-phase proteins (APP), specially of the ITIH4;~             5. immune response;~             6. endocrine response.~      METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment~     with melatonin 30mg/12 hours 28 days; 2) placebo.~      Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin~     plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein~     carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase,~     catalase, glutathione reductase and glutathione peroxidase activity; d)~     Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins:~     PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and~     immunoglobulins; g) cortisol, aldosterone, ACTH, ADH, insulin, glucagon and~     25-hydroxyvitamin D3. Data will be analyzed following a prospectively define plan and by~     intention-to-treat (ITT) analysis.~   "
91548|NCT01858896|"~     Low blood sugar can negatively affect how blood vessels function, and this can lead to an~     increase in the risk for heart attacks, strokes and other problems related to the stiffening~     and blockage of blood vessels. The purpose of this study is to learn if and how~     glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the~     effects that low blood sugar levels have on blood vessels.~   "
91549|NCT01858883|"~     Test the hypothesis that INCB039110 can be administered safely in combination with~     gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.~   "
91550|NCT01858870|"~     Lacosamide is an antiepileptic drug approved for using like adjuvant treatment in adults~     epileptic crisis.~      Previous studies has granted to the adjuvant therapy a significant efficacy. This is an~     observational study, multicenter and retrospective, in patients with epilepsy. The aim of~     study is the evaluation of the adjuvant treatment with Lacosamide administered over 12~     months.~      The investigators will collect information from 860 patients in 13 spanish centers.~      The secondary aim is assess the tolerability of treatment during 3,6 and 12 month.~   "
91551|NCT01858857|"~     The purpose of this observational multicenter-study is to investigate safety of~     psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric~     inpatients. Elderly people are at higher risk for developing side effects under~     pharmacological treatment due to an altered metabolic situation, higher comorbidity rates~     and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate~     their symptoms clearly, for example due to pronounced cognitive impairment.~      The aim of the study is to gain valid data of possible adverse drug reaction rates, their~     potential risk factors and outcome, as well as medical prescription practises.~      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the~     five participating study sites.~      At Baseline demographic data, previous and present disorders, use of drugs, previous and~     present medication, quality of life, cognitive function, physical examination results,~     laboratory results and ECG will be assessed.~      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All~     adverse drug reactions will be coded in the MedDRA-system.~      In case of a possible serious adverse drug reaction serum levels of all psychotropic~     substances applicated will be assessed. Drug combinations will be analysed using an~     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible~     adverse drug reactions are documented continually.~      2 weeks after discharge from the ward, patients will be contacted by phone to assess~     catamnestic data.~   "
91552|NCT01858844|"~     Evaluate the effect of chest manual compression technique (CCT) in the variables of~     oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are~     associated with atelectasis.~   "
91553|NCT01858831|"~     This study will be a single-center, phase I, randomized, open, in fed condition, parallel,~     single dose study to evaluate the pharmacokinetics and the safety, tolerability of~     Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male~     subjects.~      Serial blood samples will be collected for the determination of the plasma concentration of~     atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and~     the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will~     be performed for each treatment group.~      CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in~     atovaquone/proguanil dosing group.~   "
91585|NCT01858415|"~     The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This~     study was designed in order to evaluate the safety and efficacy of the TriPollar.~   "
91557|NCT01858779|"~     Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of~     ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even~     during the treatment at specialised stroke units, as paroxysmal episodes may terminate~     spontaneously before arrival at the hospital and do not always show early recurrence.~     However, the diagnosis of AF is of particular clinical relevance since adaequate~     anticoagulation is one of the most effective secondary preventive treatments in stroke. The~     detection rate of AF after stroke increases progressively by extending the duration and~     intensity of cardiac monitoring. For this purpose innovative medical devices and implantable~     event recorders have been suggested. However, high socioeconomic expenses, malcompliance and~     the invasiveness of some of these approaches currently limit their use to a minority of~     affected patients, while the growing number of stroke survivors is lacking access to free~     and simple screening tools.~      For primary prevention, the measurement of the peripheral pulse (MPP) is currently the only~     guideline-recommended screening method among individuals aged 65 years or older. In~     contrast, MPP has never been applied in the setting of secondary stroke prevention, probably~     because several factors were expected to interfere with this simple technique, including~     sensomotor and neuropsychiologic handicaps of stroke patients 18. This study investigates~     feasibility and validity of MPP in this cohort (pilot phase) and compares daily MPP for 6~     months with repeated holter-ECG in patients after ischemic stroke.~   "
91558|NCT01858766|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin~     (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C~     virus (HCV) infection.~   "
91559|NCT01858753|"~     This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to~     determine whether injection of autologous fibroblasts can increase the mobility (decrease~     the restriction) of burn scars. The study will assess the effects of azficel-T (autologous~     fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia~     (i.e., underlying structures including ligament, tendon, muscle, and bone must not~     contribute to the restriction) and that is either:~        1. An axillary scar causing 20-60% restriction of shoulder adduction~        2. An anterior elbow scar causing 20-60% restriction of elbow extension~        3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or~          extension~      Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7~     days) apart (depending on cell availability) and will be followed for efficacy (including~     range of motion measurements, scar pain and ability to perform activities) to Visit 7 and~     for safety to Visit 9 at 1 year.~   "
91560|NCT01858740|"~     This phase II trial studies how well T cell depleted donor peripheral blood stem cell~     transplant works in preventing graft-versus-host disease in younger patients with high risk~     hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Removing a subset of the T cells from the donor cells before transplant may stop this from~     happening.~   "
91561|NCT01858727|"~     30 patients American society of anesthesiology (ASA) physical status I,II and III undergoing~     general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will~     be included in the study. Patients will be randomized into two groups; first group(control~     group) and second group (forced-air warming). Resistive heating will start when patients are~     transferred to the operating room table; forced-air warming will start before preoperative~     30 minute.~   "
91562|NCT01858714|"~     The major goal of this project is to evaluate an innovative approach to obesity involving~     modification of the home environment. The project also will evaluate if home environment~     modification is more effective when supplemented with distress tolerance and related skills~     training.~   "
91563|NCT01858701|"~     The purpose of this study is to compare the amount of coma as measured by aberrometry~     induced by two silicone hydrogel toric lenses in astigmatic participants.~   "
91564|NCT01858688|"~     Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather,~     they can be followed closely with regular physical exams, blood work and repeated biopsies~     of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can~     be offered at that time. This strategy of delaying treatment until necessary is called~     active surveillance in prostate cancer.~      Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay~     unnecessary treatment in men with less aggressive cancer.~      Prostate cancer can be slow growing and, for many men, the disease may never progress or~     cause any symptoms. In other words, many men with prostate cancer will never need any~     treatment. Treatments for prostate cancer may cause side effects which can affect your~     quality of life. By monitoring the cancer with regular tests, you can avoid or delay these~     side effects.~      Active surveillance is generally suitable for men with low risk early stage prostate cancer~     that is contained within the prostate gland (localized prostate cancer).~      If doctors had a better way of identifying who might be best suited for this approach, it~     would likely become more appealing for more men. In this study, the investigators are~     looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk~     prostate cancer, which might make a man a poor candidate for active surveillance.~      To do this, the investigators are collecting data from the MRI scan of men and comparing it~     to a trans-rectal biopsy performed following the scan. The results of this study will help~     inform doctors how accurate the MRI is in identifying men who should not be on active~     surveillance.~   "
91565|NCT01858675|"~     The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR~     proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro~     Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with~     Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on~     albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers~     such as erythropoietin and catecholamines. 80 ICU patients are included.~   "
91847|NCT01854996|"~     This study aims to test plasma exposure to PF-05089771 with same formulation will be used~     for phase II trials (capsule).~   "
91571|NCT01858597|"~     Gestational diabetes mellitus (GDM) is the most common complication in pregnancy. Both~     mother and offspring have a significantly increased future risk for metabolic and~     cardiovascular disease as a consequence of GDM. Pathological insulin resistance and the~     pancreatic β-cell dysfunction may contribute to the development and adverse outcomes of GDM.~      Recently, fibroblast growth factor 19 (FGF19) and FGF21 have emerged as key endocrine~     regulators of glucose, lipid and energy metabolism. Both factors activate FGFRs in the~     context of co-receptor βKlotho(KLB) expression. After that, both proteins alter ERK~     phosphorylation and stimulate glucose uptake. Furthermore, these two factors ameliorate~     insulin resistance through various ways including up-regulating insulin mRNA, IRS-1, GLUT-1~     expressions, down-regulating GH-IGF-1 levels in different tissues and blood circulation and~     also improving dyslipidemia.~      Our previous studies showed that several factors which involved in insulin resistance and~     FGF19/FGF21 signaling pathway had differential expression in placenta from GDM and normal~     glucose tolerance pregnancy. Those led us to hypothesize that FGF19/FGF21 signaling pathway~     could play an important role in the pathogenesis and development of insulin resistance state~     in GDM.~      In the present study, we will further investigate whether maternal and neonatal FGF19/FGF21~     signaling pathway are altered and associated with insulin resistance, glucose intolerance,~     dyslipidemia and adverse pregnancy outcomes. Thus we will evaluate the regulating action of~     FGF19/FGF21 on gestational insulin resistance.~      The aim of this study is to elucidate the role of FGF19/FGF21 in insulin resistance and~     metabolic disorder in GDM.~   "
91572|NCT01858584|"~     The results on the efficacy of the formulations based on alginic acid are controversial.~     Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants~     by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid~     reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a~     lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and~     proton pump inhibitor (PPI).~   "
91573|NCT01858571|"~     Many of the pediatric malignancies are not curable on progression on front line or 2nd line~     chemotherapy. Further therapy with conventional drugs imposes many side effects and~     decreases the QOL. The usual therapy offered to such patients is best supportive care.~      Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with~     cancer that are refractory or have relapsed after conventional chemotherapy. Whether~     metronomic therapy is better than best supportive care is not known. In order to do so, a~     study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL~     in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of~     chemotherapy.~      HYPOTHESIS~      The investigators hypothesize that metronomic chemotherapy in progressive pediatric~     malignancy will improve PFS and QOL. If validated, then this form for therapy will be an~     option for both the patients and the clinicians, who are left with just an option of best~     supportive care in such situations of progressive pediatric cancers despite multiple lines~     of chemotherapy.~   "
91574|NCT01858558|"~     This research is being done to find out if altering the immune system by giving Prevnar~     vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve~     outcomes for multiple myeloma patients who receive a standard autologous stem cell~     transplant.~   "
91575|NCT01858545|"~     The primary objective of this study is to assess the effectiveness of MatriStem devices~     compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic~     foot ulcers.~   "
91576|NCT01858532|"~     This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in~     Subjects with Type 2 Diabetes and Nephropathy.~   "
91577|NCT01858519|"~     This is a point prevalence study conducted entirely in the United States (US) to establish~     the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses~     in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for~     pancreatic insufficiency compared with matched (age and region of residence) control~     patients with chronic medical conditions unexposed to PERT.~   "
91578|NCT01858506|"~     Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and~     education among Arab people with diabetes who have varying literacy skills using an~     interactive computerized tool and graphically-enhanced patient logs for dietary and physical~     activity.~      The investigators hypothesize that this tool will: a) increase patients' knowledge and~     understanding of the role of lifestyle (diet and physical activity) in diabetes management;~     b) improve patients' engagement in monitoring dietary intake and physical activity; c)~     improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM)~     practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle~     assessment, education and counseling while increasing patients' engagement in the process.~   "
91579|NCT01858493|"~     To determine whether women exposed to the continence promotion intervention will report~     improved urinary symptoms and quality of life, and lower incontinence-related stigma and~     falls than women who receive a control intervention at one-year post-intervention.~   "
91580|NCT01858480|"~     To evaluate the safety and to determine the efficacy of D-ribose for the treatment of~     congestive heart failure (CHF) in subjects who have been stabilized following~     hospitalization with acute decompensation.~   "
91581|NCT01858467|"~     The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for~     positive pressure ventilation and good first attempt insertion rate of 98% in low-risk~     patients undergoing Caesarean section. It has a double aperture design that facilitates the~     introduction of an orogastric tube to aspirate gastric contents. The current practice is to~     use endotracheal intubation with rapid sequence induction in general anaesthesia for~     Caesarean section.~      The primary study hypothesis is the first attempt insertion success rate of SLMA and~     endotracheal intubation are equivalent with a difference of less than 3%.~   "
91582|NCT01858454|"~     The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted~     laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in~     myomectomy.~   "
91583|NCT01858441|"~     Prostate cancer is the 2nd leading cause of mortality in men in developed countries. For~     metastatic prostate cancer patients, the 1st-line treatment relies on hormone therapy.~     However, the efficacy of androgen deprivation therapy remains limited in time and most~     patients eventually develop castration-resistant prostate cancer (CRPC), while remaining~     androgen-dependent.~      Docetaxel is currently the standard of care for metastatic CPRC. It has been shown that~     testosterone levels within metastatic tumoral tissue from men receiving hormone therapy were~     significantly higher than those from primitive tumors of untreated prostate cancers. Among~     the mechanistic explanations for this observation, it has been shown that CYP17A1, a key~     enzyme in de novo steroid synthesis localized in testis and adrenal gland, is up-regulated~     in CRPC metastases. The existence of de novo CYP17A1-dependent androgen biosynthesis at the~     tumor level has supported the development of novel antiandrogens, including abiraterone~     acetate (AA), an irreversible CYP17A1 inhibitor. Based on a placebo-controlled phase III~     trial, demonstrating that abiraterone prolonged overall survival (14.8 vs 10.9 months) and~     increased PSA response rate (29% vs 6%) in patients with metastatic CRPC who previously~     received docetaxel, AA was recently approved by the FDA and French Health Authorities. AA is~     well-tolerated and main toxicities are urinary tract infections (2%) and a syndrome of~     secondary mineralocorticoid excess characterized by fluid overload, hypertension and~     hypokaliema (1% to 4% of grade 3-4).~      Almost concomitantly, a novel taxane-class cytotoxic agent, cabazitaxel, has proven efficacy~     in CRPC treatment after failure to docetaxel, and has recently been approved by the FDA and~     French Health Authority. Although cabazitaxel exhibits a less favorable toxicity profile,~     this precise context creates a need to dispose of objective individual criteria so as to~     orientate patients to treatment towards AA or towards cabazitaxel. To this purpose, several~     approaches are of potential interest for identifying good candidates for a treatment by AA:~     tumor-specific TMPRSS2-ERG gene fusion measurement, circulating tumor cell analysis, tumoral~     CYP17A1 expression, analysis of splicing forms of the androgen receptor. However, the~     clinical relevance of these potential predictive factors remains to be established in this~     setting.~      Pharmacogenetics examines germinal gene polymorphisms likely to influence the~     pharmacodynamics of anticancer agents. Encouraging results have recently been reported by~     our group for irinotecan pharmacogenetics with concrete possibilities of individual dose~     adaptations, and very recently by other investigators for sunitinib pharmacogenetics.~     Concerning AA, one can hypothesize that tumors with elevated CYP17A1 expression will be more~     likely to respond better to AA. This hypothesis is indirectly supported by the observation~     that in CPRC patients receiving AA, PSA-based response is higher in patients with elevated~     pre-treatment blood concentration of DHEA and androstenedione.~      The CYP17A1 gene presents numerous single nucleotide polymorphisms (SNPs), whose frequencies~     of rare alleles are at least 12%. Their functional impact has been suggested for nine of~     them, which were linked either to the risk of developing prostate cancer or to survival of~     prostate cancer patients. So far, no study has examined the links between these~     polymorphisms and the efficacy of a CYP17A1 inhibitor. Also, relationships with the efficacy~     of androgen deprivation therapy have recently been reported for SNPs of genes involved in~     the membrane-transport testosterone and dehydroepiandrosterone, namely SLCO2B1 and SLCO1B3.~     One can make the hypothesis that gene polymorphisms of these transporters may play a role~     for the intratumoral concentration of testosterone locally-produced through the mediation of~     CYP17A1 activity.~      To resume, two second-line treatments of metastatic CRPC cancers are currently available,~     thus is raising the question in practice of which treatment is more appropriate for a given~     patient. Herein, the present study proposes an original pharmacogenetic approach in order to~     highlight a relationship between AA activity and patient's genetic profile. Ultimately, this~     could reveal evidences of genetic predispositions for potentially good responders to AA~     treatment.~   "
91584|NCT01858428|"~     This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated~     percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with~     peripheral arterial disease.~   "
91590|NCT01858350|"~     The investigators conducted a prospective open unblinded clinical four-arm evaluation of~     Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who~     were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation.~     Children were assigned to active music therapy, passive music therapy, distraction therapy,~     and no intervention; measures included doses and numbers of sedation medications, time of~     sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines,~     before and immediately after the intervention was completed. The Time Frame for the outcome~     measures are at the start of the intervention and immediately following the procedure~     (generally about 150 minutes). No further follow up was conducted.~   "
91591|NCT01858337|"~     -  Rationale: Despite the health benefits, children's consumption of vegetables is below~          the recommendations. Most human food preferences are learned through mere exposure,~          imitation, and conditioning principles. During the last years, it has become clear that~          the development of food preferences starts very early in life. Furthermore, preferences~          that are learned early in life, are relatively stable and may track into adulthood.~          However, it is unclear how vegetable preferences develop from infancy until young~          childhood. In order to influence vegetable consumption, it is essential to study the~          opportunities to develop a preference for vegetable products early in childhood.~        -  Objective: The aim of this study is to investigate the effect of repeated exposure to~          vegetables compared to repeated exposure to fruit during weaning on short and long term~          vegetable and fruit intake. Furthermore, the stability of the learned fruit or~          vegetable preferences and the later food preferences are measured (i.e. vegetable,~          fruits, sweets).~        -  Study design:~      In this longitudinal study we will measure the development of preferences for a particular~     vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period~     to fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6~     months after this exposure period. In addition, we compare the food preferences (fruit,~     vegetable, sweet foods in general), after 6 months, between infants who were weaned with a~     variety of fruits and infants who were weaned with a variety of vegetables.~   "
91592|NCT01858324|"~     Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and~     complications may help women to present early and preserve their own and their baby's~     health.~      The proposed research aims to evaluate the impact of educational tools in pregnant women~     from an ambulatory population. These tools include a detailed pamphlet (including a~     graphic-based summary), a magnet summarizing symptoms and appropriate action, and a video.~     Level of knowledge will be evaluated after one month with a validated questionnaire. We will~     also evaluate if getting more information about preeclampsia increases patient anxiety as~     well as satisfaction about the tools.~   "
91593|NCT01858311|"~     A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol~     lowering properties, both of which may benefit stroke survivors. This study is being~     conducted to determine the blood thinning and cholesterol lowering properties of TCT in~     stroke or TIA (transient ischemic attack, which is also referred to as a mini-stroke)~     survivors that are receiving the standard treatment for prevention of recurrent stroke.~      Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders,~     increases the extent of inhibition of platelet aggregation, and decreases LDL without~     significant side effects in stroke patients.~   "
91594|NCT01858298|"~     The purpose of this study is to compare the effectiveness of the conservative (pulpectomy)~     versus non-conservative treatment (tooth extraction) of primary molars affected with severe~     dental caries associated to oral health-related quality of life, anthropometric and clinical~     outcomes.~   "
91595|NCT01858285|"~     Investigators at Boston Children's Hospital are conducting research in order to better~     understand the genetic factors which may contribute to disorders related to epilepsy. These~     findings may help explain the broad spectrum of clinical characteristics and outcomes seen~     in people with epilepsy.~   "
91596|NCT01858272|"~     The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an~     intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary~     endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for~     the intra-ulcer injection of H5.020CMV.PDGF-b.~   "
91597|NCT01858259|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and all internal organs. Interstitial lung disease is a frequent morbidity and~     mortality-driving manifestation in systemic sclerosis.~      This observational trial (OT) is part of the collaborative project DeSScipher, one out of~     five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational~     try is to identify:~        -  The state of clinical practice in Europe for prevention and treatment of interstitial~          lung disease and its impact on lung function and disease progression~        -  The potential predictors and confounders for response to therapy~   "
91598|NCT01858246|"~     The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to~     randomize patients to receive either the Bonebridge or a conventional bone conducting~     hearing device. The investigators will then compare the surgical and audiological outcomes~     of the two groups.~   "
91599|NCT01858233|"~     The IBEP study is a randomized control trial of a healthy lifestyle intervention program for~     women with gestational diabetes. The primary aim of the study is to evaluate whether women~     with gestational diabetes enrolled in an intensive behavioral educational program (IBEP)~     demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose~     tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who~     undergo routine gestational diabetes education and counseling.~   "
91600|NCT01858220|"~     Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of~     mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness~     (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become~     a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized~     to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac~     disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and~     usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim~     of the study is to determine the correlation between gasytoparesis symptoms to duration of~     capsule retention in the stomach~   "
91601|NCT01858207|"~     Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative~     treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma~     (HCC) that is generally defined as maximal diameter no larger than 3cm. RFA can achieve a~     rate of complete necrosis as 80-100% in small HCC. However, the rate will drop to 71% in HCC~     of 3.1-5cm and 25% for HCC larger than 5cm。This is due to the relative hypervascularity for~     the bigger tumor and it will induce heat sink that leading to less effect of ablation.~     Therefore, transcatheter chemoembolization (TACE) before RFA may reduce the vascularity and~     enhance the effect of subsequent RFA. Moreover, pre-RF TACE will reduce the tumor size and~     the subsequent RFA will be more effective than RFA alone. In retrospective studies, Kitamoto~     M et al showed that tumor necrosis diameter was larger in TACE and RFA combination therapies~     compared to RFA mono-therapy; Yamakado K et al showed that TACE and RFA combination~     therapies in HCC (maximal diameter up to 12 cm) achieved 100% complete necrosis, 0% local~     recurrence rate and 93% of 2-year survival rate. Nevertheless, only one randomized trial in~     intermediate size HCC (3-5cm in diameter) showed that TACE and RFA combination therapies~     achieved a significant higher rate of complete necrosis, technique success, fewer treatment~     sessions to achieve complete necrosis and lower local recurrence but non-significant~     difference in 3-year survival rate. Therefore, based on the limited studies, combine TACE~     and RFA may achieve better effects than RFA mono-therapy in HCC larger than 3cm. However,~     repeat TACE may induce some complications such as HBV reactivation, hepatitis or even liver~     decompensation. Moreover, novel RFA using simultaneous multiple RFA probes with switching RF~     controller may achieve a better effects and shorter ablation time than sequential RFA with~     single electrode. Thus, is it still necessary using TACE and RFA combination therapies for~     HCC >3cm when application of novel switching RF controller? The aim of the current study is~     to conduct a RCT comparing combine TACE and RFA compared to RFA mono-therapy by using~     simultaneous multiple electrodes and switching RF controller in uni-lobar HCC of 3.1-7cm.~     The rate of complete necrosis, technique success, sessions to achieve CN, local tumor~     progression, survival rate and major complications will be analyzed. Investigators cannot~     expect which one is better, safer before the achievement of the study.~   "
91602|NCT01858194|"~     Despite significant advances in the management of ventricular arrhythmias through the use of~     ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain.~     The optimal method for the prevention of recurrent VT following catheter ablation remains~     unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and~     associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and~     the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although~     RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering~     from electrical storm, to date no large prospective randomized study has evaluated the~     impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of~     VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically~     evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in~     patients with ischemic or non-ischemic ventricular dysfunction who are to receive a~     catheter-based VT ablation.~   "
91603|NCT01858181|"~     Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting~     the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an~     increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity~     (ADCC) effector function.~      A previous phase I/II study of intravenously (IV) administered ocaratuzumab in~     refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and~     well-tolerated at doses up to 375mg/ m2 weekly for four weeks.~      In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients~     with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4~     doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety,~     tolerability, pharmacokinetic, and pharmacodynamic analyses.~   "
91604|NCT01858168|"~     This research study is a Two arm Phase I clinical trial, which tests the safety of an~     investigational drug or combination of drugs and also tries to define the appropriate dose~     of the combination of investigational drugs to use for further studies. Investigational~     means that the combination of drugs is being studied. It also means that the FDA has not yet~     approved the combination of drugs for your type of cancer.~      Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase~     (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and~     enable them to continue dividing. Olaparib has been used in research studies with other~     cancers. Information from those other research studies suggests that this drug may help to~     treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for~     any use outside of research studies.~      Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor,~     glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is~     not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for~     relapsed disease.~      Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been~     studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA~     for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.~      Laboratory studies suggest that the combination of olaparib and temozolomide and irinotecan~     may help kill Ewing sarcoma cells.~      In this research study, the investigators are looking for the highest dose of the~     combination of olaparib and irinotecan and/or temozolomide that can be given safely. The~     investigators will also begin to collect information about the effects of the combination on~     Ewing sarcoma.~   "
91605|NCT01858155|"~     This study will evaluate dose escalation of melatonin in pediatric oncology patients with~     relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at~     a dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.~   "
91606|NCT01858142|"~     Children are distressed at anesthesia induction and this distress can result in maladaptive~     recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been~     suggested as a potential intervention to decrease children's distress, and this intervention~     is widely favored by parents. However, to date, PPIA has not been found to be effective in~     reducing children's anxiety. The lack of efficacy may be attributable to the fact that~     parents have generally not been prepared for PPIA. The one study that prepared parents (as~     part of a larger preoperative preparation program) found that PPIA with preparation was~     superior to PPIA as previously studied (without preparation). Unfortunately, this program is~     resource intensive and therefore is not clinically feasible. This study will compare PPIA~     with a clinically feasible preparation program to PPIA with standard care (minimal~     preparation). Should our intervention show evidence of efficacy, the investigators will have~     designed a program that is easily translatable to everyday clinical practice. This will, in~     turn, reduce children's anxiety, improve postoperative outcomes and increase parental~     satisfaction.~   "
91607|NCT01858129|"~     Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late~     preterm and term babies caused by lung edema resulting from delayed absorption of fetal~     alveolar lung fluid.~      The investigators hypothesize that ENAC expression will be up-regulated as a result of~     administration of corticosteroids. This effect will lead to enhanced absorption of fetal~     lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled~     corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates~     presenting with TTN.~   "
91608|NCT01858116|"~     The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with~     HER2-positive or HER2-negative breast cancer.~   "
91609|NCT01858103|"~     The Expanded Access Program (EAP) is an open-label, multicenter program to:~        1. Provide patients who have been diagnosed with Mucopolysaccharidosis IVA (MPS IVA)~          access to BMN 110 until commercial product is available~        2. Collect additional information on the safety and tolerability of BMN 110 administration~          in patients with MPS IVA~      Patients enrolled in the EAP will receive 2.0 mg/kg intravenous infusions of BMN 110 every~     week during the program.~   "
91613|NCT01858051|"~     In the United States, ~1 million elective hip or knee replacement surgeries are performed~     annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this~     represents ~25,000 patients at risk of potentially avoidable morbidity following lower~     extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they~     are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also~     been identified as an independent risk factor for infections of implanted hardware.~      In general, the majority of PJIs become apparent within 3 months of hardware implantation,~     but deep infections may not be evident for up to one year after surgery. Hardware infections~     result in delayed healing, repeated surgical interventions, and long-term antibiotic~     therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional~     expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate~     compared to uninfected lower extremity joint replacements.~      Recent work from our group suggests that vitamin D insufficiency may be a risk factor for~     perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in~     elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in~     the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery.~     To date, perioperative vitamin D optimization strategies have not been reported. Therefore,~     our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative~     and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in~     patients scheduled for elective hip or knee joint replacement surgery.~   "
91614|NCT01858038|"~     This project aims to understand the molecular biology underlying the improvement of surgical~     scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH~     have shown that FP significantly improves the appearance and functionality of surgical and~     burn scars. At the Wellman Center, we have conducted a randomized, controlled study on~     linear surgical scars demonstrating the efficacy of FP to decrease the volume of~     hypertrophic scars, and to improve the appearance and texture of scars. However, the~     underlying mechanism of this therapeutic effect is unknown. It is clear that FP induces~     wound healing and remodeling of the normal skin surrounding microthermal zones (MTZs).~     Furthermore, other researchers have employed animal models using transgenic zebrafish and~     the mouse eye, and found that laser treatments induce changes in gene expression in specific~     cells. We propose to determine whether the effect of FP on scar improvement occurs via~     changes in patterns of local gene expression within the skin, specifically dermal~     fibroblasts. By characterizing these changes, we may be able to identify molecular~     mechanisms that both explain and contribute to the beneficial effects of FP in the surgical~     and traumatic scar. The molecular insights into the therapeutic effects of fractional laser~     photothermolysis may provide a basis for future therapeutic strategies to improve scar~     remodeling.~   "
91615|NCT01858025|"~     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical~     to do this type of research ona larger scale in the future. The pilot part of the study is~     to assess the possibility of using pencil beam proton radiation to treat your type of~     cancer. Proton radiation is used for many other types of malignancies, but its use for the~     treatment of anal cancer has been limited. The treatment is still being studied as research~     doctors are trying to find out more about its use in the treatment of anal cancer. Proton~     beam radiation therapy is an FDA approved radiation delivery system.~      You are being asked to participate in this study because you have cancer in the anal canal.~     Conventional radiation therapy with photons in combination with 5-FU and mitomycin-C is used~     as standard treatment for many patients with anal cancer.~      In this research study we are looking at another type of radiation called proton radiation,~     which is known to spare surrounding tissue and organs from radiation. Proton radiation~     delivers radiation to the area requiring radiation but delivers no dose beyond the region~     requiring treatment. There are several techniques that can be used to deliver proton~     radiation therapy. One of the newer techniques, called pencil beam scanning, allows for more~     accurate delivery of radiation to your tumor and further reduces the amount of normal tissue~     exposed to radiation. Most proton patients are treated with a number of beams that study~     doctors conform to the shape of your tumor. Pencil beam scanning delivers radiation with a~     single, narrow proton beam that is swept over the area of your tumor. This may reduce side~     effects that patients would normally experience with conventional radiation therapy or other~     means of delivering proton radiation therapy, and also minimizes treatment time.~      In this research study, we are evaluating the effectiveness of using pencil beam proton~     radiation delivered to reduce side effects associated with radiation treatment.~   "
91616|NCT01858012|"~     The study hypothesis is that the means by which HCV induces glucose intolerance is through~     impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with~     insulin resistance and that HCV eradication improves these abnormalities. It is also~     hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with~     Latinos with or without HCV infection.~   "
91617|NCT01857999|"~     The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting~     enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients~     has been demonstrated to be beneficial. However, the dual inhibition has not been studied~     during heart failure decompensation or even when low cardiac output is present.~      The objective of this study was to assess the effects of add-on therapy with angiotensin~     receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in~     heart failure patients with low cardiac output during hospitalization for decompensation.~      This was a randomized, double-blind, placebo-controlled clinical trial.~   "
91618|NCT01857986|"~     This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to~     standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The~     main effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks~     between the endotracheal tube and the trachea walls as a result of the cuff pressure~     management. Since the primary outcome can't be measured by any method other than the~     investigational device, the study groups will be treated as follows:~        -  The Treatment group in this study will be treated with the fully functional AnapnoGaurd~          100 device (per its intended use),~        -  The Control group will be treated with the AnapnoGuard device, where the cuff control~          will be disabled (off) and the cuff management will be done according to SOC.~      Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage~     around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety~     will be measured by adverse events (AEs).~   "
91619|NCT01857973|"~     This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study.~     The goal of the study is to demonstrate that the Overnight Closed Loop (OCL) System is safe~     to be used in an even larger study outside of hospital.~   "
91757|NCT01856166|"~     Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented~     delivery rates.~      To assess the best maintainance regimen of epidural analgesia during labor the investigators~     plan to include 300 nulliparous in this multicenter randomized, double blind trial. The~     primary outcome will be a composite set of criteria that can lead to instrumented delivery.~     Secondary outcome will focus on analgesia motor block and satisfaction.~   "
91620|NCT01857960|"~     Acne is a chronic inflammatory disease that affects almost 100% of the teenagers worldwide.~     The peak incidence is between 12 and 18 years old, although it can be present in adults.~     There are many different beliefs about what can cause or exacerbate acne, and also about~     treatment.~      In Mexico, 26.4% of the population is between 15 and 29 years old, which represents that~     more than 25% of the population is at risk for presenting acne. In our country, the~     different beliefs about the causes and treatment of acne among general adolescent population~     have not been explored. The objective of the present study is to determine the possible~     causes for which young Mexicans do not go to the dermatologist to receive treatment for~     acne. Our main hypothesis is that the lack of knowledge of the disease is responsible for~     this behavior.~   "
91621|NCT01857947|"~     The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition~     to clinical evaluation is effective to predict outcome of acute exacerbations of COPD~     patients visiting the emergency room(ER).~   "
91622|NCT01857934|"~     Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of~     patients presenting with widespread metastatic disease. The current treatment for this group~     of high-risk patients includes intensive multi-agent chemotherapy (induction) followed by~     myeloablative therapy with stem-cell rescue (consolidation) and then treatment of minimal~     residual disease (MRD) with isotretinoin. Recently a new standard of care was established by~     enhancing the treatment of MRD with the addition of a monoclonal antibody (ch14.18) which~     targets a tumor-associated antigen, the disialoganglioside GD2, which is uniformly expressed~     by neuroblasts. Despite improvement in 2-year event-free survival (EFS) of 20%, more than~     one-third of children with high-risk neuroblastoma (HR defined in) still cannot be cured by~     this approach. Therefore, novel therapeutic approaches are needed for this subset of~     patients. This study will be a pilot Phase II study of a unique anti-disialoganglioside~     (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy.~      PRIMARY OBJECTIVE:~        -  To study the efficacy [response: complete remission + partial remission (CR+PR)] to two~          initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4~          doses/course followed by GM-CSF) in previously untreated children with high-risk~          neuroblastoma.~        -  To estimate the event-free survival of patients with newly diagnosed high-risk~          neuroblastoma treated with the addition of hu14.18K322A to treatment.~      SECONDARY OBJECTIVES:~        -  To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy~          and describe the antitumor activity (CR+PR) of this 6 course induction therapy.~        -  To estimate local control and pattern of failure associated with focal intensity~          modulated or proton beam radiation therapy dose delivery in high-risk abdominal~          neuroblastoma.~        -  To describe the tolerability of four doses of hu14.18K322A with allogeneic natural~          killer (NK) cells from an acceptable parent, in the immediate post-transplant period~          [day +2 - +5 after peripheral blood stem cell (PBSC) infusion] in consenting~          participants.~        -  To describe the tolerability of hu14.18K322A with interleukin-2 and GM-CSF as treatment~          for minimal residual disease (MRD).~   "
91623|NCT01857921|"~     Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory~     properties. In addition, previous reports showed that trimetazidine was effective in~     reducing intracoronary platelet aggregation and preventing platelet thrombogenesis.~     Therefore, for the evaluation of these combination effects of statin and trimetazidine on~     patients with aspirin monotherapy who had previously received CABG and were free of the~     major adverse cardiac events such as death, MI, TLR, or TVR for 12 months, the investigators~     hypothesize that atorvastatin 40mg/day would be more effective in the prevention of the~     further late adverse cardiac and cerebrovascular events than other statin. To test this~     hypothesis, the investigators will perform a multi-center, randomized, prospective trial~     aimed at demonstrating the superiority of combination of high dose atorvastatin therapy and~     trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG~     surgery in real world practice.~   "
91624|NCT01857908|"~     Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate~     treatment, particularly at the time of progression. Biomarkers may also help identify~     pathways to resistance of abiraterone acetate treatment. The most practical way of~     approaching this question is to explore surrogate biomarkers of prostate cancer including~     quantification of pharmacodynamic endocrine biomarkers.~   "
91625|NCT01857895|"~     This is an open-label study to investigate the feasibility of administering exenatide by~     continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.~     Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours~     followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B~     approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for~     maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.~   "
91626|NCT01857882|"~     The purpose of this study is to determine the effectiveness of a pre-consultation decision~     support workshop for breast reconstruction after breast cancer, in facilitating the~     decision-making process, compared to routine pre-surgical education.~   "
91627|NCT01857869|"~     This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of~     GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1~     months and 1/5th standard dose at 7 months (delayed fractional dose group) and 257049~     administered as three standard doses one month apart (0, 1, 2-month group) in healthy~     malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.~      An additional, delayed sporozoite challenge will assess persistence of protection induced by~     the primary immune schedule and if an additional dose can provide protection in those~     unprotected by the initial vaccination series.~   "
91628|NCT01857856|"~     In the Netherlands ≈15% of idiopathic dilated cardiomyopathy (DCM) and ≈10% arrhythmogenic~     right ventricular cardiomyopathy (ARVC) patients carry a single (founder) mutation in the~     gene encoding Phospholamban, PLN R14del. Analogous to other inherited cardiomyopathies, the~     natural course of the disease is age-related (age-related penetrance); after a~     presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease,~     and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum~     Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+~     homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The~     investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with~     eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a~     strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.~   "
91720|NCT01856647|"~     Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and~     risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular~     disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose~     tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene~     expression will enable us to identify inflammation in this tissue and may help us to~     understand the causes and consequences of obesity in order to determine how these cells~     might be implicated in the initiation and/or progression of the aforementioned diseases.~   "
91629|NCT01857843|"~     Objective: To evaluate the early effects of intensive lipid lowering treatments with~     ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.~      Study Design~        -  Prospective, randomized, single-center study of each 80 subjects enrolled~        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria~          will be enrolled.~        -  Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B)~          Pravastatin (n=80), and each group of patients will be randomized further in a ratio of~          1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.~        -  All subjects will undergo VH-IVUS at initial procedure.~        -  Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial~          procedure and 3-months will be performed in available cases.~   "
91630|NCT01857830|"~     The purpose of this research study is to examine whether a short term meditation~     intervention can improve health, mood, and biological markers of cellular stress and aging~     in novice and experienced meditators compared to controls.~   "
91631|NCT01857817|"~     The purpose of this study is to evaluate the clinical benefit of the co-administration of~     propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate~     cancer.~   "
91632|NCT01857804|"~     The objective of this randomized controlled clinical trial is to evaluate the outcome of~     treatment of peri-implantitis with or without systemic antibiotics.~      Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on~     the healing process, and (ii) the risk for recurrence of disease following surgical~     treatment of peri-implantitis.~   "
91633|NCT01857791|"~     Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the~     prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1~     Although several pediatric weight management programs are available, access to these~     programs may not always be possible.~      The proposed study will be an ongoing research program with approximately 40 children ages~     12-18 years enrolled into the study over a year. All study participants will participate in~     a baseline evaluation which will include body composition measures, aerobic testing, as well~     as nutrition and physical activity questionnaires. Study participants will be assigned to~     the clinic-based group. The clinic- based group will participate in a 12-week~     multi-disciplinary weight management program. All study participants will then participate~     in a 12-week follow-up evaluation similar to the baseline visit. New participants will be~     enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a~     minimum of 12 weeks) will have the option to continue in the program or, discontinue their~     active participation in the program and enroll into the maintenance phase which will consist~     of measures only every 12 weeks.~      The objective of the proposed study includes examining the efficacy of the clinic-based,~     multi-disciplinary, pediatric weight management program.~   "
91634|NCT01857778|"~     There will be breast tissue changes after use of a breast pump.~   "
91635|NCT01857765|"~     The purpose of this study is to determine whether implementing a rehabilitation program can~     improve the post-operative time to pain free living after breast augmentation.~   "
91636|NCT01857752|"~     Primary Objectives:~        1. To investigate the response rate (complete response plus partial response) of~          temozolomide for 8 weeks (2 cycles), in patients with retinoblastoma metastatic to the~          central nervous system (mass only) in two strata:~             -  A. Initial diagnosis (mass)~             -  B. At relapse (mass)~        2. To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and~          hemoglobin count.~      Secondary Objectives:~        1. To determine the response in other metastatic sites (non target) (orbit, bone marrow,~          bone, lung, liver and others)~        2. To determine the remission rate and time to relapse on temozolomide.~        3. To document the response of leptomeningeal metastasis (cerebrospinal fluid) to~          temozolomide~   "
91637|NCT01857726|"~     The aim of this study is to compare the efficacy of transarterial chemoembolization with~     adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion~     with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.~   "
91638|NCT01857713|"~     The purpose of the study is to determine the safety and effectiveness of non-invasive Reza~     Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal~     symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat,~     throat clearing).~   "
91639|NCT01857700|"~     Research questions: What effect does provision of food vouchers have on uptake of voluntary~     medical male circumcision? What is the amount of food voucher that should be given?~      Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages~     due to VMMC and who undergo VMMC will be higher than the percentage of men who are~     compensated for lost wages or travel and undergo VMMC, and both of these percentages will be~     higher than the percentage of men who are not compensated for travel or lost wage costs but~     undergo VMMC.~   "
91640|NCT01857687|"~     To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear~     stress and total plaque force on coronary atherosclerotic plaque and to collect the~     preliminary data to apply those parameters for the prediction of clinical outcomes in~     patients with coronary artery stenosis.~   "
91641|NCT01857674|"~     -  For patient in intensive care unit, extubation failure is defined as the necessity of~          early reintubation after scheduled extubation, with Increased morbidity and mortality,~          so it seems important to quickly identify patients with high risk of post-extubation~          acute respiratory failure.~        -  Major post-extubation laryngeal edema is one of extubation failure causes, and its~          incidence vary in literature from 4 to 37%.~        -  We can't currently predict arising of a major post-extubation laryngeal edema. However,~          a recent pilot study showed that laryngeal ultrasonography could help to identify~          patients with high risk of post-extubation stridor, measuring ultrasonic leak volume~          and cuff-deflated air-column width, of which we propose to assess diagnostic~          performance.~   "
91721|NCT01856634|"~     The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent~     to the adult dose already shown to be effective against multidrug-resistant tuberculosis.~   "
91722|NCT01856621|"~     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler~     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.~   "
91642|NCT01857661|"~     The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a~     digital new hearing aid with an integrated sound generator. These prototypes assist both~     hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of~     the population).~      Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the~     development of devices for the hearing rehabilitation as well as the treatment of tinnitus~     represents an advance in the implementation of Public Policies in Brazil.~      The aim of this study is to compare the efficacy of the hearing aid with an integrated sound~     generator and amplification alone for tinnitus control in patients with tinnitus associated~     hearing loss.~   "
91643|NCT01857648|"~     The aim of this study is to test a methodology of counseling on physical activity among~     Community Health Workers working within primary health care in Brazil.~   "
91644|NCT01857635|"~     In patients suffering from hypercapnic respiratory failure and treated by non invasive~     ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2~     and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements~     will be done during one-hour NIV treatments.~   "
91645|NCT01857622|"~     To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial~     fibrillation patients with severe renal impairment, compared with DU-176b administered to~     non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal~     impairment (Normal/MiRI).~   "
91646|NCT01857609|"~     This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics~     and pharmacodynamics of metformin in healthy Korean men.~   "
91647|NCT01857596|"~     The purpose of this study is to investigate whether Lorexys is effective and safe to treat~     premenopausal women who have lost their sexual desire to a distressing degree.~   "
91648|NCT01857583|"~     To assess the safety and pharmacokinetics of DU-176b administered to patients with severe~     renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b~     administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of~     the lower limbs.~      For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of~     the lower limbs will be compared with that of fondaparinux.~   "
91649|NCT01857570|"~     The purpose of this study is to evaluate whether standard volume computed tomography (CT)~     has impact on treatment in patients with suspicion of fractures of the wrist and carpus.~   "
91650|NCT01857557|"~     This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist~     in patients with migraine. Patients can be assigned to one of two groups 1)The exercise~     group or 2)non-exercise group. This is a important area to study because there is currently~     limited information regarding exercise and its impact on migraine frequency and severity. In~     many cases, migraine patients are disabled by their headaches and sometimes will not have a~     significant response to medications. As a result, it is important to study other~     non-pharmacological interventions. In this study, the investigators hope to show the~     benefits of exercise by a reduction in number of headache days per month as well as by~     improvement in quality of life, disability,depression,anxiety,and aerobic fitness.This study~     will not interfere with the usual treatment patients receive at our headache clinic and~     patients can remain on medications deemed necessary.~   "
91651|NCT01857544|"~     The purpose of this study is determine the number of patients with complete resolution of~     macular edema secondary to central retinal vein occlusion following 6 monthly injections of~     Aflibercept.~   "
91652|NCT01857531|"~     The purpose of this research study is to evaluate whether the investigational drug~     ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated~     (in other research studies) for the treatment of seizures and migraines. This drug is~     considered investigational in the US.~   "
91653|NCT01857518|"~     Adolescence is a critical period for the development of depressive disorders. As adolescence~     also is a critical period for brain maturation, it may be hypothesized that maturation~     changes in emotional circuits could underlie vulnerability for depression.~      The aims of the study are (1) to identify the changes in brain morphometry, white matter~     microstructure, and functioning, in networks associated with depression features in~     adolescents, and (2) to assess the effects of treated pathology on brain structure by~     comparing the neuroimaging measures obtained in adolescents at inclusion with those at~     follow-up.~   "
91654|NCT01857505|"~     The investigators propose to evaluate and compare the percentage of patients who are able to~     be discharged in less than 3 days after undergoing total hip arthroscopy through either a~     direct anterior or posterior approach, utilizing the identical post operative protocol. The~     investigators also propose to evaluate the costs associated with the two different~     approaches to hip replacement in the same group of patients. Post operative resource~     utilization, discharge disposition, and pain medicine requirement will also be evaluated.~   "
91655|NCT01857492|"~     This study is testing whether the addition of a noninvasive form of brain stimulation called~     transcranial direct current stimulation (tDCS) when combined with meditation helps decrease~     the abdominal pain in patients with chronic pancreatitis. The device involved in this study,~     transcranial direct current stimulation (tDCS) is investigational. This means that the study~     device is still being tested in research studies and is not approved by the Food and Drug~     Administration [FDA].~   "
91656|NCT01857479|"~     Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease~     the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).~   "
91694|NCT01856985|"~     These pilot studies are designed as open label studies to investigate the acceptability of~     200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered~     buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in~     gestations 78-84 days' LMP. They will be done consecutively.~      Findings from the pilot studies will guide the development of a larger, multi-site study to~     investigate the efficacy of outpatient medical abortion regimens for women with gestations~     from 78 - 84 days LMP. In that end, the pilots seek to collect information on the~     acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed~     by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable?~     Women's rating of the tolerability of any side effects will also be documented.~   "
91723|NCT01856608|"~     Assessing the utility of the Team SA instrument in measuring the effectiveness of~     communication across disciplines during ICU rounds.~   "
91657|NCT01857466|"~     Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts~     and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of~     the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar~     coagulation could result in the damage of ovarian reserve and decrease the response of the~     ovaries to hormonal stimulation for assisted reproductive technologies. The possible~     mechanism may contribute to thermal destruction of ovarian follicles by excessive use of~     bipolar coagulation for hemostasis purposes.~      To avoid additional ovarian tissue damage by conventional bipolar coagulation being~     potentially important ovarian reproductive function, hemostasis using various topical~     hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among~     them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix~     sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact~     with blood after application at a bleeding site, the gelatin particles swell and tamponade~     bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood~     flow and providing exposure to a high thrombin concentration, thus hastening clot formation.~     Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where~     there is superficially pervasive focus of bleeding.~      Ovarian reserve is defined as the functional potential of the ovary, which reflects the~     number and quality of antral follicles left in the ovary, and is correlated with the~     response to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone~     (AMH) has been accepted as the most reliable and easily measurable marker for postoperative~     assessment of ovarian reserve.~      The investigators conducted a multicenter, large-scale, randomized controlled trial to~     investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in~     preserving ovarian reserve by assessing serial AMH levels in patients undergoing~     laparoscopic ovarian cystectomy for benign ovarian cysts.~   "
91658|NCT01857453|"~     Adult medulloblastoma is a rare tumour.~      The standard risk  group (complete surgery or residual tumour lower than 1,5 cm2, absence~     of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC~     amplification and exclusion of large cells medulloblastoma) concerns, for the adult~     population, a majority of patients at diagnosis (about ¾ of cases).~      Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy~     on the posterior fossa and 36 Gy on the nevraxis).~      This treatment is associated with an acute toxicity (haematological, cutaneous, digestive~     and general) wich decreases gradually when patient goes away from the treatment period.~      For this category of patients and this modality of treatment, The French intergroup~     experience, pleads in favour of a late and progressive neurotoxicity.~      This neurotoxicity is associated with a clear degradation of the quality of life.~      In the light of paediatric studies :~      We propose a phase II study to estimate the interest of a decrease of radiation doses~     compensated by a chemotherapy according to the following schedule~        1. carboplatine + etoposide based chemotherapy every 28 days x 2~        2. followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the~          in toto neuro axis and 54 Gy on the post operative bed.~      The majority of French centres concerned with the neuro-oncology are involved in this trial.~      About 25 new cases by year are waited. A centralized analysis of pathological slides and of~     the pre and post surgery Magnetic Resonance Imaging is foreseen.~      The main objective is to estimate the survival without disease at 1 year~      Secondary objectives associate the evaluations of the rate of complete response at the end~     of procedure, the overall survival, the survival without disease, the survival without~     events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the~     time until definitive deterioration of the quality of life Associated studies~      Two associated studies are besides foreseen (parallel search for co-financing):~        1. A biologic study is planed with the aim to confirm, by morphological, genomic and~          transcriptomic studies, the interest, for the adult population, of the prognostic~          markers used in paediatric population~        2. A radiological study is planed with the aim to estimate the interest :~             -  of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature~               detection of recurrences~             -  of the study of functional connectivity in correlation with the neuropsychological~               follow-up for the analysis of the aetiology and premature markers of~               neurotoxicity.~   "
91659|NCT01857440|"~     This study is designed to investigate whether the pupil response to slowly flashing colored~     lights is significantly altered in patients with glaucoma, as compared to a control group of~     subjects without glaucoma.~   "
91660|NCT01857427|"~     The primary objective of this study is to build a well characterized cohort of patients that~     will be used to determine the genetic variants associated with obstructive sleep apnea~     (OSA)and its co-morbidities.~   "
91661|NCT01857414|"~     The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can~     improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year~     in patients presenting with ST-elevation Myocardial Infarction and undergoing primary~     percutaneous coronary intervention. This will be done in a multinational~     investigator-driven, multi-centre, randomised, controlled, single-blind, parallel~     assignment, prospective clinical efficacy trial.~   "
91662|NCT01857401|"~     There is currently no experimental model that accurately represents sarcoidosis. The lack of~     a useful research model significantly slows progress towards developing new treatments for~     sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will~     test the model to see if it helps us understand how sarcoidosis develops and if it is useful~     for testing new treatments.~   "
91663|NCT01857388|"~     Implementation of an adapted ParentCorps program in Ugandan schools will improve school~     mental health service resources, teachers' knowledge about child mental health, and~     teachers' classroom behavioral management and parent involvement skills.~   "
91664|NCT01857375|"~     This research is to determine the use of insulin pens compared to syringe and vial therapy~     in adults newly begun on insulin therapy during their hospital stay.~   "
91665|NCT01857362|"~     The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg~     capsules in healthy volunteers.~   "
91666|NCT01857349|"~     The goal of this study is to determine the superiority of surgical scrub preparations in~     total knee arthroplasty based on the bacterial counts present on the skin surface and in the~     deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub~     preparation, post preparation after the application of the sterile drapes, deep joint tissue~     sample prior to wound closure, and immediately post wound closure. This study will provide~     an assessment of the management of sterility by comparing quantitative and qualitative~     cultures immediately after surgical scrub preparation and the maintenance of sterility~     throughout the procedure. This study will enhance prior research efforts by contributing~     quantitative bacterial load and bacterial load within the surgical wound at closure.~   "
91667|NCT01857336|"~     Poor graft function (PGF) is a common complication after allogeneic stem cell~     transplantation, which was associated with high mortality. The pathogenesis fo PGF was~     poorly understood. Infusion of donor peripheral cell harvest was effective for some patients~     with PGF in our preliminary study. This present study aimed to explore the efficacy of~     peripheral cell harvest for poor graft function.~   "
91668|NCT01857323|"~     This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of~     the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The~     purpose of this study is to evaluate the functionality, reliability, and accuracy of the~     Albuterol Spiromax inhaler integrated dose counter in a clinical setting.~   "
91724|NCT01856595|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.~   "
91725|NCT01856582|"~     The purpose of this study is to determine if infusing additional special donor cells will~     help to improve graft or immune function in previously transplanted children with immune~     deficiencies and bone marrow failures.~   "
91669|NCT01857310|"~     The overarching goal of this trial is to determine if an intervention comprising folic acid~     and zinc dietary supplementation improves semen quality and indirectly fertility outcomes~     (i.e., live birth rate) among couples trying to conceive and seeking assisted reproduction.~     The following study objectives underlie successful attainment of the overarching research~     goal:~        1. To estimate the effect of folic acid and zinc dietary supplementation on semen quality~          parameters, including but not limited to concentration, motility, morphology, and sperm~          DNA integrity, relative to the placebo group.~        2. To estimate the effect of folic acid and zinc dietary supplementation on fertility~          treatment outcomes [fertilization, embryo quality, implantation/human Chorionic~          Gonadotropin (hCG) confirmed pregnancy, clinical pregnancy, live birth], relative to~          the placebo group.~        3. To estimate the association between semen quality parameters, sperm DNA integrity and~          fertility treatment outcomes (fertilization, embryo quality, clinical pregnancy, live~          birth) and to identify the best combination of semen quality parameters for prediction~          of clinical pregnancy and live birth.~        4. To estimate the effect of folic acid and zinc dietary supplementation on fertilization~          rates among couples undergoing assisted reproductive technology procedures, relative to~          the placebo group.~        5. To estimate the effect of folic acid and zinc dietary supplementation on embryonic~          quality among couples undergoing assisted reproductive technology procedures, relative~          to the placebo group.~   "
91670|NCT01857297|"~     This is a study to assess the immune (antibody) response and safety of the 2013/2014~     formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.~   "
91671|NCT01857284|"~     Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical~     effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.~     The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of~     UDCA, and has been approved by state food and drug administration in China for treatment of~     cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the~     treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,~     double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion~     of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total~     bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or~     UDCA for 24 weeks.~   "
91672|NCT01857271|"~     This phase II trial studies how well erlotinib hydrochloride works before surgery in~     treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~   "
91673|NCT01857258|"~     The objective of this study is to formulate and validate a green tea confection (i.e.~     gummy candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in~     vascular function. The central hypothesis is that a green tea confection will protect~     against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The~     central hypothesis of this application will be assessed by developing a green tea-containing~     confection, examining its physiochemical properties and its inhibition of starch digestion,~     and then validating its vasoprotective activities in healthy humans by assessing its blood~     glucose-regulating activities.~   "
91674|NCT01857245|"~     Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S.~     infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response~     (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care~     and their success in HCV treatment has been limited. With direct-acting antiviral agents,~     HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of~     genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates~     are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR~     will develop drug resistance, but the optimal adherence level to minimize resistance is~     unknown. If HCV treatment continues to be delivered within current models of care, most IDUs~     will not only fail treatment and develop resistance, but may transmit resistant viruses to~     others. We have previously developed a multidisciplinary model of HCV care which integrates~     on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care~     within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two~     models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group~     therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if~     applicable, and one daily dose of oral medication is administered at the methadone window.~     In our CGT model, patients initiate HCV treatment within a once weekly treatment group which~     provides powerful social support to mitigate fears of side effects, promote efficient~     education, and deliver weekly injections, if applicable. It is unknown whether either model~     is better or more cost-effective than standard on-site care.~      PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited~     from methadone clinics and randomized to one of three models of care: DOT; concurrent group~     treatment; or standard on-site care. Our specific aims are: 1) To determine whether either~     of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more~     efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing~     drug resistance; (2) To determine the incidence and factors associated with the development~     of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each~     model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes~     among HCV-infected IDUs.~      PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be~     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will~     be offered the choice of model of care (either standard on-site, DOT, or concurrent group~     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort~     of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and~     (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 /~     IFN-ineligible) initiating a 24 week IFN-free regimen.~      PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be~     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will~     be offered the choice of model of care (either standard on-site, DOT, or concurrent group~     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort~     of opiate agonist treatment patients initiating treatment with oral DAA combination of~     sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine~     adherence rates over time in drug users.~   "
91675|NCT01857232|"~     Comparison of efficacy of APD403 at preventing delayed sickness in patients who have~     received cancer chemotherapy~   "
91676|NCT01857219|"~     To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up~     to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be~     invited to complete the second, identical fMRI session about 3 months following completion~     of the first session. Fibromyalgia subjects will complete their scans before and after a~     12-week Tai Chi intervention in collaboration with Tufts Medical Center.~   "
91677|NCT01857206|"~     Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents~     4 to 17 years of age.~   "
91678|NCT01857193|"~     Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in~     combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to~     characterize the safety and tolerability of the combinations of everolimus + exemestane +~     LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer~      Dose Expansion part of the study: To characterize the safety and tolerability of the triplet~     combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6~     inhibitor based therapy, and the safety and tolerability of the doublet combination of~     LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except~     patients treated with prior LEE011 are not allowed in Group 3).~   "
91679|NCT01857180|"~     Laparoscopic surgery has become the standard approach to a vast variety of surgical~     procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation,~     amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a~     different set of skills than in open access surgery. Acknowledging this, several~     comprehensive curricula have been developed to teach basic skills as well as advanced~     laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to~     surgery no designated curricula have been developed to introduce medical students to the~     technique of laparoscopic surgery.~      Participation in an introductory curriculum in laparoscopic surgery results in improved~     cognitive and technical performance compared to self-directed learning. The greater~     homogeneity and fewer dropouts amongst those in the curriculum group suggest that a~     structured curriculum is essential in ensuring standardization of clinically relevant~     training. An introductory curriculum for medical students should be delivered in a~     structured and standardized fashion prior to clinical exposure in order to maintain~     motivation and enhance learning.~   "
91680|NCT01857167|"~     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and~     related traits in response to the six month treatment of omega-3 fatty acids, including fish~     oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty~     acids, will be selected as a controlled oil. The investigators hypothesize that omega-3~     fatty acids could improve insulin sensitivity and glucose metabolism in Chinese type 2~     diabetic patients.~   "
91681|NCT01857154|"~     The purpose of this study is to determine whether consuming calcium carbonate that has been~     micronized is more effective than the traditional form of calcium carbonate in maintaining~     or increasing bone mineral density in people who are currently taking bisphosphonates or~     other bone-health medications.~   "
91682|NCT01857141|"~     The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved~     postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist~     and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a~     useful tool to assess cardiac autonomic activity. We investigated whether preemptive~     epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by~     HRV.~   "
91683|NCT01857128|"~     The purpose of the study is to learn about the best way to treat pilonidal cyst wounds and~     learn which type of bandage (or dressing) can help the wound heal faster after having~     surgery.~   "
91684|NCT01857115|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)~     patients.~   "
91685|NCT01857102|"~     The purpose of this study is to determine the benefits of fitting low astigmats with soft~     toric contact lenses versus spherical contact lenses with regard to visual comfort,~     eyestrain, fitting efficiency, and visual performance.~   "
91686|NCT01857089|"~     The aim of this study is to assess the intra and inter-subjects variability of the pressure~     measurement cartography in healthy and well and able volunteers, sitting on a rigid base~     during two hours.~   "
91687|NCT01857076|"~     There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical,~     gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in~     a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2~     diabetes mellitus and obesity class I. In order to compare the effect of weight loss on~     glycemic control among medical and surgical groups, and after 2 years of follow up, the~     results of efficacy, safety and maintenance will be compared between the three groups.~   "
91688|NCT01857063|"~     This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment~     of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary~     hypothesis of this study is that montelukast is superior to placebo in the treatment of~     nasal symptoms in SAR.~   "
91689|NCT01857050|"~     Many drug interactions with Warfarin are well documented in the literature, including~     interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict~     when the interaction remains theoretical and when it becomes clinically significant and will~     be reflected in the individual patient. This study's aim is to identify and characterize~     related conditions (including comorbidities, laboratory test results and other parameters~     related to the patient)that might be predictors for drug interactions turning from~     theoretical to clinically significant.~   "
91690|NCT01857037|"~     Inclusion criteria:~        -  Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after~          radiation therapy for prostate cancer addressed for prostate biopsy OR~        -  Patients referred to our institution for biopsy-proven local recurrence after radiation~          therapy for prostate cancer but needing a re-assessment with biopsy (insufficient~          number of biopsy and/or imprecise location of positive biopsy and/or questionable~          diagnostic of recurrence)~      Study Design:~        -  Included patients will undergo an endorectal US examination with a Histoscanning™~          acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic~          contrast-enhanced) MRI.~        -  Two independent operators will separately define suspicious focal lesion on~          Histoscanning™ images and on MR images.~        -  Random biopsies (at least 2 cores) will be performed in sextants negative at~          Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI,~          targeted biopsies will be performed in the suspicious part of the sextant (at least two~          cores per suspicious lesion).~        -  Histoscanning™ and MRI results will be compared to biopsy results.~      A total of 30 patients will be included~   "
91691|NCT01857024|"~     The primary objective of this study is to assess in a post-approval clinical setting the~     safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult~     hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum~     phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of~     Product Characteristics (SmPC) and followed according to the investigator's standard~     clinical practice management. Each patient will be followed up for 12 months or up to the~     time they start dialysis, whichever occurs first.~   "
91692|NCT01857011|"~     The purpose of this study is to determine whether intravenous or oral iron are effective in~     the treatment of postoperative anemia and iron deficiency in patients submitted in~     postbariatric abdominoplasty.~   "
91726|NCT01856569|"~     Observe in real life adherence therapy and time to switch in ankilosing spondylitis patients~     with predominant assial involvement with 4 anti-TNF.~   "
91695|NCT01856972|"~     This study will examine the short term effects of adding manual therapy techniques to static~     stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2~     forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument~     assisted soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching~     versus IASTM + static stretching versus static stretching alone the investigators wish to~     see if there are any short term benefits in DF ROM by adding either of these interventions~     to static stretching.~      The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be~     taken 4 times over a 2 week period.~      The population that the investigators wish to examine are subjects with healthy feet and~     ankles, but with limited DF ROM.~      The primary objective of this study is to see if subjects with decreased dorsiflexion motion~     will experience greater increases in dorsiflexion motion with the addition of manual therapy~     of static stretching alone.~      Our hypothesis is subjects who receive manual therapy therapy and static stretching will~     experience a significant increase in DF ROM as compared to subjects who receive static~     stretching alone. More specifically subjects who are treated with the IASTM will experience~     greater results than subjects who are treated with the rear-foot thrust mobilization.~   "
91696|NCT01856959|"~     As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered~     intravenously in the treatment of the patients with acute severe asthma not responding to~     conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted~     in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of~     intravenous MgSO4 administered is not common in clinical practice, because it's prone to~     have adverse effects and side effects such as nausea, vomiting, facial flushing,~     hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route~     offers the advantage of lower dosage, a shorter time of drug being delivered to the airway~     smooth muscle and lower incidence of side effects when compared to the intravenous route. At~     present, there are only a few studies about the effects of nebulized MgSO4 in the treatment~     of acute asthma in children, and the conclusions are controversial.~   "
91697|NCT01856946|"~     Childhood obesity is a rapidly growing epidemic in the US and the world. Current estimates~     suggest that 30% of our nation's children are either overweight ot obese. Obesity is a major~     risk factor towards the development of insulin resistance, which, in turn is a major risk~     factor for the development of type 2 diabetes. Prior research has suggested that vitamin D~     therapy may be a safe, inexpensive, and effective method of reducing insulin resistance and~     a person's risk of developing diabetes.~      The investigators' prior studies have shown that daily 4,000 IU vitamin D therapy is a safe~     and effective method of improving insulin resistance based on a calculation called the~     HOMA-IR.~      The next step in identifying whether vitamin D truly improves insulin resistance is to use~     oral glucose tolerance testing (OGTT), which is a better real-life measure of insulin~     resistance compared to the previously used HOMA-IR.~   "
91698|NCT01856933|"~     The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane~     Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain~     tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.~   "
91699|NCT01856920|"~     Background:~      - GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been~     modified to help the immune system target a protein called CEA. CEA is found on the surface~     of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if~     GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain~     the CEA protein. They will test to see whether this vaccine is a safe and effective~     treatment for medullary thyroid cancer that has not responded to earlier treatments.~      Objectives:~      - To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have medullary thyroid cancer that has not~     responded to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and tumor samples and have an imaging study of the neck and chest. They~          will also have a skin test to make sure that they are not allergic to the yeast in the~          vaccine.~        -  Participants will be divided into two groups. One group will start to take GI-6207~          immediately for 1 year. The second group will have 6 months of monitoring and tests~          with no vaccine, and then will take GI-6207 for 1 year.~        -  GI-6207 will be given every other week for the first seven visits (about 3 months), and~          then monthly for the remaining year of treatment. It will be given as injections~          beneath the arm and in the upper thigh. These locations will help the vaccine enter the~          lymph nodes and reach the immune system more quickly.~        -  Participants will be monitored with frequent blood and urine tests and imaging studies.~        -  Participants will have regular follow-up visits after their year of study vaccines.~   "
91700|NCT01856907|"~     Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with~     onset or first recognition during pregnancy. GDM is one of the most frequent metabolic~     disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United~     States are complicated by gestational diabetes resulting in more than 200,000 cases~     annually. There is epidemiologic evidence associating GDM with insulin resistance, glucose~     intolerance, and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the~     experience of gestational diabetes is the strongest one. Systematic reviews of older studies~     conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates~     much greater than control groups who did not have glucose intolerance during pregnancy.~     Studies are needed for optimal postpartum and long-term health of women who have had GDM.~     Recent evidence suggests that incretin-based therapies may be useful for the treatment of~     DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces~     substantial improvements in glucose control and ß-cell function in subjects with DM2.~     Inhibition of dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may~     potentially delay disease progression in GDM considering the ß-cell function improvement in~     DM2 and ß-cell mass shown to increase in animal models. This study will examine if~     combination sitagliptin (a DPP-4 inhibitor)-plus metformin is more effective than metformin~     alone or placebo in improving metabolic parameters, specifically the impact on β-cell~     function, in prior GDM women with glucose abnormalities.~   "
91701|NCT01856894|"~     In this study the investigators aimed to investigate whether there is a relation between~     body weight and serum anti mullerian hormone levels in adults with polycystic ovary~     syndrome. For this purpose the investigators designed a prospective study including three~     groups. The group I is defined as adults with polycystic ovary syndrome and body mass index~     is greater than 25. The group II is defined as adults with polycystic ovary syndrome and~     body mass index is less than 25. The group III is defined as adults with non-polycystic~     ovary syndrome and body mass index is less than 25. The all three groups are compared~     considering their serum AMH levels,lipid profiles, sex steroids and glycemic analyses.~   "
91702|NCT01856881|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2~     diabetes.~   "
91703|NCT01856868|"~     (-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired~     skeletal muscle function in Becker Muscular Dystrophy (BMD) patients. This is a~     proof-of-concept phase 1/2a pilot and endpoint development study that is designed to provide~     initial evidence of biological activity of (-)-epicatechin. Primary endpoints include~     initial assessment of tissue-specific evidence of efficacy from muscle biopsy samples.~     Secondary endpoints include measures of strength and physical function, and safety and~     adverse event data. Pilot endpoints include assessment of mRNA and miRNA peripheral blood~     profiles and validation of non-invasive near-infrared spectroscopy (NIRS) muscle perfusion~     studies during exercise and a recumbent cycle exercise test that may be employed as~     endpoints in future clinical trials.~      This single center open-label pilot study will enroll 10 adults with genetically-confirmed~     Becker muscular dystrophy, who will receive the purified nutritional extract (-)-epicatechin~     100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the~     study if they meet all inclusion criteria. They will be evaluated at baseline and at~     screening, day 1, and weeks 1, 2, 4 and 8.~   "
91704|NCT01856855|"~     This study will investigate the safety, tolerability, and effectiveness of giving a higher~     dose to the part of the prostate which contains the cancer while giving a standard radiation~     dose to the entire prostate. The investigators have hypothesized that this treatment~     technique will effectively control the prostate cancer while minimizing the side effects.~   "
91705|NCT01856842|"~     AVMs are abnormal collections of blood vessels which can occur in any part of the body~     including the lungs. These blood vessels are weakened and can rupture anytime causing~     bleeding which can be massive, leading to life-threatening conditions.~      Pulmonary AVMs occur in about 40% of patients with HHT. Each patient may have an average of~     5 AVMs .Rupture of the AVM can lead to massive bleeding in the lung, stroke and infection of~     the brain. In order to prevent these complications, patients with HHT are routinely examined~     for pulmonary AVMs and treatment with embolization is recommended.~      AVMs have a main blood vessel or artery supplying blood to the collection of blood vessels.~     The way to treat AVMs is cut off their blood supply through a process called embolization.~      Embolization is a standard medical procedure which is done to stop or prevent hemorrhage~     (bleeding) from an AVM. It involves blocking the artery that supplies blood to the AVM by~     inserting a foreign body, into the blood vessel supplying blood to the AVM.~      Standard devices used for embolization include coils (made of stainless steel or platinum).~     These devices usually have a good success rate for blocking the artery that supplies blood~     to the AVM. However, a few AVMs that are embolized by standard devices may reopen over time.~     This is called reperfusion and will require repeat embolization procedures.~      For embolization of pulmonary AVMs at St. Michael's Hospital, the Nester coil is used. In~     this study, we would like to compare the Nester coil with a new coil device called the~     Interlock Fibered IDC Occlusion System. Both coils are approved for use in Canada, however~     the cost of the IDC coil limits its use at this hospital.~      Compared to the Nester coil, the IDC coils are made so that they can be removed or~     repositioned if they are not placed correctly. The coil also allows tighter packing which~     helps prevent reperfusion.~      This study will compare the success rate of embolization between the Interlock™ Fibered IDC™~     Occlusion System (IDC coil) and the Nester coil.~   "
91706|NCT01856829|"~     Omega 3 in the form of phospholipids are the main component of nerve cells and their oral~     intake is known to have a positive impact on behavior disorders such as depression or~     bipolar disorder. Their consumption would improve brain function while increasing the~     ability to concentrate. The study aims to determine the effect of an increase in Omega 3 in~     the form of phospholipids on the processing of visual information in the brain and in~     particular the attention and perceptual-cognitive learning in a three dimensions~     environment. Eighty subjects (40 young (18-35 years) and 40 older (60-75 years)) divided~     into four groups, two Omega-3 (20 young and 20 older) and two other placebo (20 young and 20~     elderly ), will in this study, performing a complex perceptual-cognitive task such as the~     pursuit of moving objects in a 3D space. This stimulus was chosen because it is very similar~     to the situations of daily life, but also because it involves a mechanism of~     perceptual-cognitive level. The main objective is to demonstrate the positive effect of~     Omega-3 phospholipids on the perceptual-cognitive training.~   "
91707|NCT01856816|"~     The purpose of this research study is to determine how different meal patterns influence the~     absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is~     that carotenoid absorption will be lower when daily vegetables are consumed in one meal~     compared two smaller meals throughout the day.~   "
91708|NCT01856803|"~     Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen~     (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of~     acute GVHD is significantly higher in patients at 40 years of age or more than those at 18~     to 39 years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used~     for prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG~     in patients at 40 years of age or more in matched sibling allo-SCT settings might~     significantly decrease the incidence of acute and chronic GVHD and the incidence of late~     effect after transplantation.~   "
91709|NCT01856790|"~     Closed loop artificial pancreas systems have been under development for the control of~     blood sugars in those living with diabetes. These systems consist of a continuous glucose~     sensor, which sends a signal to a computer program that automatically determines how much~     insulin to give. The computer program then tells an insulin pump to deliver the insulin.~     While such systems have been tested under a number of conditions, post-meal blood sugars are~     difficult to control. This study is designed to see if liraglutide, a glucagon like peptide~     receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1~     diabetes while they are on a closed loop system.~   "
91710|NCT01856777|"~     This randomized study will examine the effectiveness of two types of pregnancy tests (a~     semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home~     at various time points after early medical abortion. The first test a semi-quantitative~     panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This~     urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The~     second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test,~     Phamatech, San Diego, CA, USA).~        1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly~          identify ongoing pregnancy at day 14.~        2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly~          identify ongoing pregnancy at day 7.~        3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly~          identify ongoing pregnancy at day 4.~   "
91711|NCT01856764|"~     The purpose of this study is to evaluate the effect of topical roflumilast on the reduction~     of atopic dermatitis lesions in adults with atopic dermatitis.~   "
91781|NCT01855854|"~     This study is designed to evaluate the efficacy and safety of icotinib in treating advanced~     carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+)~     or positive FISH, the primary endpoint is objective response rates.~   "
91712|NCT01856751|"~     Occurrence of inhibitors to coagulation factor VIII is diagnosed in ~30% patients with~     haemophilia A. Presence of inhibitor with a titre >5 BU/ml requires the use of by-passing~     agents: recombinant activated Factor VIIa concentrate (rFVIIa) and/or activated prothrombin~     complex concentrate (APCC). Similarly, haemorrhagic complications in patients with acquired~     haemophilia and inhibitor titre >5 BU/ml should be treated with by-passing agents.~      Response to treatment with by-passing agents is patient-specific, and can vary in the same~     patient during subsequent bleedings. Some patients have good response to both products,~     however in other patients a better bleeding control is provided by one of the mentioned~     above agents (APCC or rFVIIa). There are clinical situations when severe bleedings requires~     an alternate use of both these agents.~      Traditional methods of laboratory tests used post-treatment in patients with haemophilia~     without inhibitors are useless in the presence of inhibitor. Laboratory monitoring of~     therapy with by-passing agents is possible with the use of global tests for the coagulation~     process assessment, which are as follows: thrombin generation assay (TGA) and~     thromboelastometry (TEM).~      Several studies revealed that TGA allows a monitoring of therapy with by-passing agents in~     patients with haemophilia A and inhibitor - the choice of the most effective treatment~     option - agent type and its dose, as well as laboratory assessment of treatment efficacy.~      Up to date, laboratory tests assessing the efficacy of by-passing agents in patients with~     acquired haemophilia were not conducted.~      In Factor VIII or IX deficiency conditions, fibrin's fibres generated by thrombin are~     morphologically thicker, and blood clots have increased susceptibility to fibrinolytic~     enzymes. Blood clot stability may be assessed with the use of thromboelastometry (TEM). We~     can hypothesize that simultaneous use of TGA and TEM methods may allow for an assessment of~     patient's individual response to therapy with by-passing agents. Clinical significance of~     the minimal dose of APCC and rFVIIa, needed to TGA and TEM normalization, requires further~     studies.~      Tests' purpose: Examination of the hypothesis that simultaneous use of thrombin generation~     assay (TGA) and thromboelastometry (TEM) may facilitate the choice of optimal therapy with~     by-passing agents and laboratory monitoring of efficacy of those agents in patients with~     acquired haemophilia or haemophilia A with inhibitor.~   "
91713|NCT01856738|"~     Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's~     disease (PD). As an independent predictor for cognitive decline and nursing home placement~     they form an important disability milestone in the course of PD. According to current~     clinical guidelines minor VH do not require treatment per se. But as minor VH precede the~     stage of major VH without insight and PD associated psychosis (PDP) they offer an~     opportunity for early intervention. Neuroleptic drugs delay the transition into PDP but are~     unsuitable for early treatment of VH due to their side effects. We hypothesize that~     cholinesterase inhibitors (ChEI) are a well-tolerated alternative for the early treatment of~     minor VH to delay the progression to PDP, and that brain network analysis is suitable to~     predict treatment response.~      Objective: Investigate whether early treatment with ChEI delays the progression of minor VH~     to major VH without insight or PDP. In addition, we will measure motor control, psychotic~     symptoms, cognitive impairment, mood disorders, daytime sleepiness, adverse events and~     compliance, disability, caregiver burden and care use. We assess the cost-effectiveness of~     early chronic treatment of VH with ChEI. Finally, we analyse changes of functional brain~     networks before and during treatment.~      Study design: A randomized, double blind, placebo-controlled, multi-center trial with an~     economic evaluation.~      Study population: 168 patients with PD and VH after fulfilling the in-and exclusion~     criteria.~      Intervention: Rivastigmine capsule 6 mg BID or placebo BID for 24 months.~      Main study parameters/endpoints: The primary outcome measure is the median time until PD~     patients with minor VH progress to major VH without insight. The clinical endpoint is~     defined as the start with antipsychotic treatment. Secondary outcome measures are changes in~     motor control, psychotic symptoms, cognitive impairment, mood disorders, daytime sleepiness,~     cholinergic deficiency, the number of adverse events, compliance, disability and caregiver~     burden. The median time until PD patients with minor VH progress to PD dementia is measured~     by means of changes in cognitive function. The secondary neurophysiological outcome measures~     are peak frequency, functional connectivity, topological network organisation and the~     direction of information flow. All relevant costs will be measured and valued.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The burden of participation consists of a total of 5 clinical visits (every 6~     months), 5 telephone interviews on adverse events during the escalation phase and 9~     questionnaires on health related costs (every 3 months). In a subgroup 3 additional visits~     for EEG recording are needed. There is a risk for adverse reactions with rivastigmine~     treatment; the most common are nausea and vomiting.~   "
91714|NCT01856725|"~     The purpose of this study is to compare the efficacy of cardiac resynchronization therapy~     (CRT) device programming with hemodynamic measurements to device programming without~     hemodynamic measurements.~   "
91715|NCT01856712|"~     The over-arching goal of the proposed project is to understand the impact of medication~     adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed~     project is a pilot feasibility study of inpatient veterans with problem alcohol use at the~     William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of~     two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to~     hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg~     intramuscular injection of naltrexone administered prior to discharge and a second injection~     one month later. The central hypothesis is that hospital-administered injectable naltrexone,~     when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days~     immediately following hospitalization. Injectable naltrexone has been efficacious vs.~     placebo in addition to behavioral treatment in several studies. However, it has yet to be~     examined in head-to-head comparison with oral naltrexone, or in the hospital setting as an~     intervention that might facilitate behavioral treatment follow up after discharge.~   "
91716|NCT01856699|"~     Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of~     cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a~     primary focus on future stroke and mortality.~   "
91717|NCT01856686|"~     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial~     effects in behavior and brain connectivity of different dietary patterns in 100 children~     with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.~   "
91718|NCT01856673|"~     This study is a community prevention randomized trial with three parallel groups: two~     intervention groups and one control group in Buenaventura and Quibdó.~      The aim of the trial is to evaluate the impact of two community interventions on mental~     health; the intervention groups are designed to decrease depression, anxiety, post-traumatic~     stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims~     of violence.~      Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in~     both cities will participate in the enter survey. The subjects will be selected based on the~     severity of symptoms, traumatic experiences and a level of dysfunction identified using the~     instruments of this research (i.e. those obtaining an score equal or higher than 49 in~     symptoms (25% of the total of symptoms)).~      The fieldwork and the interventions will be conducted by people belonging to the community;~     they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal~     training, they will be able to perform two kinds of interventions, Common Elements Treatment~     Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group~     Therapy (NCGT), for the people affected by violence and displacement that were pre-selected~     according to the baseline instrument.~      The LPCW will be under the constant supervision by psychologists of the project, and under~     weekly supervision by a group of experts from Johns Hopkins University, the Heartland~     Alliance and The Institute for Research and Development in Violence Prevention and Promotion~     of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the~     cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the~     waiting control group.~      The study subjects will follow their allocated treatment, or waiting in the control group,~     for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks~     after the last session of therapy.~      The study outcome is the differences in instrument scores between the follow-up and the~     baseline among the interventions (CETA or NCGT) and control group.~      Control subjects will be assessed by the project psychologist after the follow-up, and they~     will receive treatment when necessary.~   "
91719|NCT01856660|"~     Individual food preferences are not considered in designing weight-loss therapies. This~     project will determine if short-term weight-loss is improved by matching participants with~     diets that reflect their genetically-determined food preferences.~   "
91804|NCT01855555|"~     Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing~     field of practice, especially in children. Propofol is the most common sedative drug~     administered for MRI/CT. However, this drug is associated with adverse events, including~     pulmonary complications, and there has been no report on these complications in Korea. In~     this prospective observation study, the investigators will report the nature and frequency~     of adverse events associated with propofol-based sedation for MRI/CT.~   "
91727|NCT01856556|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and~     severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis,~     changes in physical examination findings and subject-reported symptoms.~      The secondary objectives of this study are to assess the plasma and cerebrospinal fluid~     (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the~     renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.~   "
91728|NCT01856543|"~     The purpose of this study is to find out if the effect of mometasone furoate is any~     different from Eucerin in decreasing the severity of redness of the skin during irradiation,~     preventing the skin from peeling, or reducing the amount of irritation the patient reports~     during treatment.~   "
91729|NCT01856530|"~     The purpose of this study is to learn more about how the hormone, oxytocin, impacts social~     behavior in terms of cooperation with others, attention processing, and reward processing,~     among patients with social anxiety disorder. Based on available research, the investigators~     predict that in patients with social anxiety disorder, oxytocin will improve social~     cooperation during an online ball-tossing game called Cyberball, reduce attention toward~     socially threatening cues during a dot-probe task, and lead to greater willingness to work~     for monetary rewards for others rather than themselves during an effort expenditure task.~   "
91730|NCT01856517|"~     The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous~     noradrenaline. The working hypothesis is that the higher the plasma concentration of~     endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline~     will be. This will be tested in patients presenting with septic shock, following state of~     the art management (including repeated assessment of vena cava diameter and compliance, and~     response to dynamic indices of loading) following placebo vs clonidine administration (1~     mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of~     noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).~   "
91731|NCT01856504|"~     To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected~     improvements in image quality and diagnostic accuracy.~   "
91732|NCT01856491|"~     The objective of this study is to gather data to establish the chronic safety, performance~     and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.~   "
91733|NCT01856478|"~     This randomized, open-label, phase III study will be performed in patients with recurrent~     and/or metastatic head and neck cancer which has progressed after platinum-based therapy.~     The objectives of this trial are to compare the efficacy and safety of afatinib versus~     methotrexate.~   "
91734|NCT01856465|"~     Non-alcoholic fatty liver disease (NAFLD) includes benign hepatic simple steatosis (SS) and~     steatohepatitis (NASH), which is characterised by inflammation leading to fibrosis and~     cirrhosis. NAFLD is the hepatic manifestation of the metabolic syndrome, and the prevalence~     is 74-98% in morbidly obese individuals undergoing bariatric surgery. Although steatosis~     improves post bariatric surgery, hepatic inflammation and fibrosis do not consistently~     improve. Alterations of the human gut flora (intestinal microbiota; IM) may play a role. One~     mechanism linking IM to obesity, insulin resistance (IR), and NAFLD is through translocation~     of bacterial lipopolisaccharide (LPS=endotoxin) into the blood stream (=endotoxemia),~     causing chronic inflammation. Morbidly obese subjects have different IM compared to lean~     controls, and the IM structure is significantly altered after bariatric surgery, probably~     due to a combination of anatomic changes, diet, and weight loss. For example, the ratio of~     Firmicutes/Bacteroidetes may be lower in obese subjects compared to lean controls and lower~     numbers of Faecalibacterium prausnitzii were reported in some obese subjects before~     bariatric surgery, which increased 3 months post-surgery. This is of interest since, in~     animal studies, low abundance of F. prausnitzii, a butyrate producing bacterium, is~     associated with increased intestinal permeability, endotoxemia, and inflammation. To our~     knowledge, only two studies are available describing IM in patients pre and post bariatric~     surgery, and no data have been published on the relationship between IM and NAFLD in these~     patients.~   "
91735|NCT01856452|"~     Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It~     provides the surgeon the evidence of axillary lymph node metastasis, which determines the~     extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node~     dissection, it is increasingly important. In general, radioactive colloid has been used for~     SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method~     enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.~      In this study, our hypotheses are as following:~        1. Multimodal method enables to increase identification rate of SLNB~        2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better~          outcome~        3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an~          identification strategy~   "
91736|NCT01856439|"~     The study is designed to assess the long term tolerability of ProSavin and whether it is~     safe and efficacious in patients administered ProSavin from the PS1/001/07 study .~   "
91737|NCT01856426|"~     The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV~     gentotype-1 in chronically infected subjects and to further evaluate the safety profile of~     EDP239.~   "
91754|NCT01856205|"~     Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of~     an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening~     conscious level and seizures. Around a third will die from the infection and half of~     survivors have serious long-term neurological disability. The majority of those affected are~     children. There are many causes of viral encephalitis, however Japanese encephalitis virus~     is the most common cause worldwide with over 60,000 cases annually. It occurs over much of~     Asia and the geographical range is expanding. There is no specific treatment for Japanese~     encephalitis virus, although several have been trialed. In this study we examined the effect~     of a new treatment, called intravenous immunoglobulin, on children with Japanese~     encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may~     neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It~     has previously been used in individual cases but never examined in a randomized trial. There~     was recently a trial of IVIG in West Nile encephalitis in the United States, in which~     Professor Solomon was on the Scientific Advisory Committee. In this study we will look if~     intravenous immunoglobulin is safe in this context, and that this treatment may alter the~     way the immune system manages the infection. Therefore, in this pilot study we will test the~     hypothesis that IVIG can be safely given to children with suspected JE, with no increased~     risk of serious adverse events compared with placebo. The aim of this proposal is to conduct~     a pilot safety and tolerability randomized placebo controlled trial of intravenous~     immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship~     between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier~     markers, and the effect of IVIG on these relationships.~   "
91738|NCT01856413|"~     Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure~     require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved~     preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral~     antiviral medication. In the first 6 months after liver transplantation, patients receive~     treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody~     concentrations above 100 IU/L, the level considered safe for preventing hepatitis B~     reinfection.~      Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for~     the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver~     transplantation for hepatitis B induced liver failure'. The purpose of this study is to show~     that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can~     prevent hepatitis B reinfection.~      Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of~     patients and is more convenient for patients compared to intravenous treatment that must~     take place in the hospital setting.~      Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy~     and Spain. Patients who are eligible for the study will receive treatment with Zutectra for~     24 weeks.~      During the study, the safety and effectiveness of Zutectra will be assessed by checking for~     symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs~     antibodies and hepatitis B surface antigen (HBsAg).~   "
91739|NCT01856400|"~     There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in~     heart muscle. This gene is also found in blood vessels and skin tissue. When active this~     gene builds a crucial protein inside the heart muscle called SERCA2a protein. This is~     responsible for regulating calcium levels inside your heart muscle. When this gene is not~     activated, studies have shown that it can lead to abnormal electrical currents in the heart~     that can lead to death. The investigators are conducting this study to prove that SERCA2a~     gene is inactive in patients with kidney disease. Scientists found that patient at risk for~     abnormal electrical currents in the heart can be tested by what they called microvolt Twave~     alternans. This is a very delicate machine much more sensitive than a regular~     electrocardiogram that you do at the cardiology office.~   "
91740|NCT01856387|"~     Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial~     dysfunction. In recent years, it has been reported that the individual components of the~     differential white cell count, specifically the neutrophil and lymphocyte counts,may have~     clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic~     indicator in various malignancies. İn the literature, many studies have been shown that NLR~     have predictive value in determining the prognosis of various diseases (cardiac or~     noncardiac diseases ). However, little is known about the predictive values of NLR in~     pregnancy complications. This study aimed to evaluate the potential predictive value of NLR~     in preeclampsia- eclampsia.~   "
91741|NCT01856374|"~     This study is a prospective open-labeled, randomized study to compare the neointimal~     coverage at 3 months and 12 months and its serial changes between 3 months and 12 months~     according to the implanted DES and evaluate the serial changes in the proximal portions of 3~     epicardial coronary artery and left main artery including the assessment of fibrous cap~     thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will~     compare the changes such as plaques and neointimal coverage from serial OCT follow-up~     according to the different statin strategy.~   "
91742|NCT01856361|"~     This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and~     promoting sperm production in men with low sperm count. Ramipril is an Angiotensin~     Converting Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However,~     previous studies have shown that this class of medications can improve sperm parameters. The~     purpose of this study is to evaluate the efficacy of ramipril compared to placebo (Substance~     That is not known to have treatment effect), in improving sperm density in infertile men~     with documented low sperm count. This study will help us identify subjects that might~     benefit from treatment with this medication, and the effect it will have on sperm count,~     shape, and motility.~   "
91743|NCT01856348|"~     The study is conducted to assess the effect of a vitamin D3 supplementation on the~     activities of two intestinal transporters and on the pharmacokinetics of the transporter~     substrates folic acid and fexofenadine.~        -  Trial with medicinal product~   "
91744|NCT01856335|"~     Study Population~      -People with seizures benefit from regular exercise. Exercise may help decrease the number~     of seizures they have. It also improves overall health and quality of life. However, people~     with seizure disorders often have been prevented from doing sports or other regular physical~     activity. They may also feel that exercise or injury can increase their risk of seizures.~     Researchers want to try an exercise program for people who have seizures to see if they can~     increase motivation to exercise which will improve overall health and may decrease the~     frequency of seizures.~      Objectives:~      - To see how exercise education improves motivation to exercise in people who have a history~     of seizures.~      Eligibility:~      - Individuals at least 18 years of age who have a history of seizures.~      Design:~        -  This study involves three outpatient visits and weekly telephone calls for about 12~          weeks. There will be followup calls at about 6 and 12 months after the outpatient~          visits.~        -  Participants will be screened with a physical exam and medical history. They will~          answer questions about their current level of physical activity, mood, quality of life,~          and ideas about exercise.~        -  At the first visit, participants will learn how to keep a physical activity log and~          seizure calendar. They will also use an activity monitor and take their pulse~          regularly. They will complete questionnaires about their mood and thoughts about~          exercise and seizures.~        -  At the second visit, participants will set personal activity goals and learn about~          physical activity and seizures. They will review the physical activity log, seizure~          log, and activity monitor and pulse readings for the previous 4 weeks.~        -  After the second visit, participants will receive weekly telephone calls. Each call~          will last about 5 minutes. These calls will ask about physical activities for the week~          and participants' progress toward meeting their goals. These calls will also review the~          seizure log.~        -  At the third visit (12 weeks), the same tests from the first visit will be repeated.~        -  The followup phone calls will continue to monitor participants' activity levels.~   "
91755|NCT01856192|"~     This randomized phase II trial studies how well rituximab and combination chemotherapy with~     or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse~     large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the~     ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the~     immune system in different ways and stop cancer cells from growing. It is not yet known~     whether rituximab and combination chemotherapy are more effective when given with or without~     lenalidomide in treating patients with diffuse large B cell lymphoma.~   "
91848|NCT01854983|"~     Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence~     imaging for the screening of cervical cancer~   "
91745|NCT01856322|"~     Background:~      - Some types of inflammation may increase the risk of cancers in the intestinal track.~     Because of this possibility, anti-inflammatory drugs may be able to prevent tumor growth and~     spread. One such drug, sulindac, may be helpful to study. Researchers want to see if people~     who are having surgery to remove intestinal tumors from advanced colorectal cancer will~     benefit from sulindac. It will be tested against a placebo.~      Objectives:~      - To see if sulindac can improve treatment outcomes in people who are having surgery for~     advanced colorectal cancer.~      Eligibility:~      - Individuals at least 18 years of age who are having surgery for advanced colorectal~     cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies and heart and lung function tests may also be given.~        -  Participants will be separated into two groups. One group will take sulindac. The other~          will take a placebo.~        -  Participants will take sulindac or placebo twice daily from about 2 to 3 weeks before~          the scheduled surgery. Seven days before the surgery, they will stop taking the pills.~        -  Participants will have surgery to remove their tumors. The surgery will also remove~          affected organ tissue.~        -  Participants will start to take the pills again once they have recovered from surgery.~          They will continue taking the sulindac or placebo twice a day for 3 years, or for as~          long as the tumors do not return.~   "
91746|NCT01856309|"~     The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136~     (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment~     with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.~   "
91747|NCT01856296|"~     An open non-randomized study using biology driven selection of therapies. WINTHER study will~     explore matched tumoral and normal tissue biopsies and will use a novel method for~     predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic~     choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/~     translocations/ amplifications, etc.) or not. The total number of patients treated in the~     study will be two hundred across all participating cancer centers (European countries~     -France; Spain-, Israel, USA and Canada). All centers will realize the same study~     independently.~   "
91748|NCT01856283|"~     This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients~     with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells~     (CD34+/lin-) in BM during nilotinib treatment.~      In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP)~     of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and~     Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at~     diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12~     months).~   "
91749|NCT01856270|"~     The investigators propose to conduct a 2-arm, open-label pilot study to determine if early~     treatment with amitriptyline will decrease the frequency and severity of headaches after~     mild traumatic brain injury (TBI). Amitriptyline is a tricyclic antidepressant that is~     commonly available and inexpensive. It is used as a first-line drug for primary headache~     prevention in a very low dose range of 10-50 mg.~        -  Specific Aim 1 is to conduct a 2-arm open-label study to examine the effect of~          preventive treatment with amitriptyline on the frequency and severity of headache after~          mild TBI.~        -  Specific Aim 2 is to collect data needed for design of a Phase 3 study, including an~          estimate of effect size, headache variability, and desirable drug treatment start date.~        -  Specific Aim 3 is to examine the feasibility of using headache diaries with individuals~          with mild TBI.~        -  Specific Aim 4 is to establish the safety and tolerability of amitriptyline for the~          prevention of headache after mild TBI.~      The investigators hypothesize that early preventive treatment with amitriptyline will avert~     the development of chronic post-traumatic headache (PTH) as compared to rates of headache~     from a recent natural history study on PTH after mild TBI.~      The investigators propose to enroll inpatient subjects from a Level I trauma center as well~     as from outpatient clinics and from the general community with a diagnosis of mild TBI.~     Subjects will be screened for current headache. After baseline assessment, 72 subjects with~     current headache will be randomized to one of 2 groups. Group 1 will immediately begin~     amitriptyline and or Group 2 will be followed and begin amitriptyline at Day 30. All~     subjects will be asked to complete a daily headache diary beginning on Day 1 of the study. A~     detailed medical history and headache survey will be completed. Subjects will have a~     scheduled stepped increase in the drug dosage every week for 3 weeks to the maximum study~     dosage of 50 mg. Weekly telephone calls will monitor for adverse events and compliance with~     the drug and headache diary. Clinic visits will occur at 30, 60 and 90 days. The 30 day~     clinic visit will include cognitive testing to assess for differences between groups and~     initiation of drug treatment for Group 2. Both 30 and 60 day visits will include review of~     headache diary, potential adverse effects, and pill counts. The 90 day visit will be for~     outcome assessment. In addition, the headache survey will be repeated by telephone at Day~     180.~   "
91750|NCT01856257|"~     The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of~     improving long-term graft function without increasing the risks of immunologic graft injury~     by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.~   "
91751|NCT01856244|"~     Persons with Morbus Parkinson commonly develop gait and balance disorders leading to~     dependence, loss of mobility and a high risk of falling.~      This study investigates the effectiveness of a sensorimotor treadmill intervention to~     improve walking and balance abilities in persons with early stages of Parkinson's disease.~     The sensorimotor treadmill training is conducted on a special treadmill device which is~     challenging the participants by small oscillations. This intervention, which is supposed to~     simulate walking on natural, uneven surfaces, is compared to a conventional treadmill~     training.~      Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and~     balance abilities as compared to conventional treadmill exercise.~   "
91752|NCT01856231|"~     The purpose of this preliminary study is to examine the effects of a program that includes~     two-months of structured lab-based training. The proposed study will examine the effects of~     a lifestyle physical activity intervention designed to increase PA in people with moderate~     and severe COPD. The intervention includes a combination of (a) structured laboratory-based~     exercises with a behavioral intervention, (b) structured home-based exercises and (c)~     lifestyle physical activities performed at home. The subjects will be followed for a total~     of 18 weeks.~   "
91753|NCT01856218|"~     UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of~     UX003 in MPS 7 subjects via IV administration every other week (QOW) for 36 weeks with up to~     an additional 36 weeks from the optional continuation period. Up to 5 subjects, who are~     between 5 and 30 years of age inclusive, will be enrolled and treated with UX003.~      The initial 12-week treatment period will be followed by a 24-week forced dose titration~     period to assess the optimal dose. Subjects who complete both the initial treatment and~     forced dose titration periods will continue treatment in a 36 week continuation period~   "
91756|NCT01856179|"~     The objective of this study is to investigate the conversion of the precursors ALA and SDA~     into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in~     comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3~     LC-PUFA is compared between subpopulations of different age, gender and physiological~     conditions (overweight, increased serum total cholesterol).~   "
91758|NCT01856153|"~     Primary objective is to determine if the efficacy of strawberries delivering polyphenols to~     prevent metabolic inflammation will be influenced by timing of consumption relative to meal~     intake.~      Secondary objective is to characterize the relative bioavailability and absorption profile~     of strawberry polyphenols consumed with meal or at alternatives times around a meal (2 hours~     before the meal ad 2 hours after the meal).~      Third objective is to determine the bioavailability/absorption profile of strawberry~     polyphenols and its relationship with the anti-inflammatory mechanism of action of~     strawberry constituents.~   "
91759|NCT01856140|"~     Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived~     mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be~     administrated to the patients with lateral epicondylitis by ultrasonographic guided~     injection.~   "
91760|NCT01856127|"~     This is a three-center, randomized, double-blind, fixed dose study designed to assess the~     efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction~     associated with use of a selective serotonin reuptake inhibitor (SSRI) and~     serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in~     patients with Major Depressive Disorder (MDD).~      Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin~     specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the~     SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to~     placebo.~   "
91761|NCT01856114|"~     The goal of this clinical research study is to learn if fentanyl can change perception of~     shortness of breath in cancer patients. Researchers also want to learn if the study drug can~     help to improve your physical function. In this study, fentanyl will be compared to a~     placebo.~      Fentanyl is commonly used for treatment of cancer pain.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
91762|NCT01856101|"~     The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that~     plays an important role in cell growth, proliferation, survival and angiogenesis through~     sensing and integrating energetic signals from cellular environment. The mTOR protein is~     composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).~      In regards of mTOR pathway dysregulations observed in TCC development, there is a rational~     to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition,~     binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.~   "
91763|NCT01856088|"~     The main objective of this study is to evaluate the effectiveness of stent Inspiron ™~     sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in~     native coronary arteries.~   "
91764|NCT01856075|"~     This is an international observational multicentre study to be conducted in Germany, Spain,~     Italy and USA. The main objective of the study is to evaluate the relative effectiveness of~     dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest.~     The design of the study is a historic-prospective cohort with dynamic exposure and~     stratified competitive recruitment with balanced comparison groups of dronedarone versus~     alternative antiarrhythmic drugs of interest.~   "
91765|NCT01856062|"~     The purpose of this study is to determine if the addition of dexamethasone to clomiphene~     citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.~   "
91766|NCT01856049|"~     Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many~     years. However, congenital heart disease with severe structural abnormalities may also be~     reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally~     growing and may be the most amendable to regenerative strategies. Therefore, identifying~     autologous cells (cells from the patient's own body) would be important to initiate these~     studies.~      This study aims to validate the use of umbilical cord blood as a source of autologous cells~     for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from~     the cord blood to help us determine the feasibility of collection, processing, and storage~     of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left~     heart syndrome. This study may be useful for the development of pre-clinical and clinical~     studies aimed at the long-term goal of repairing damaged heart muscle.~   "
91767|NCT01856036|"~     This protocol will study the impact of cryoablation on immune response in patients diagnosed~     with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to~     cryoablation of invasive breast cancers. The intra-tumoral and systemic immune response to~     cryoablation will be determined and compared to pre-ablated breast cancer specimens and~     historical control specimens.~   "
91768|NCT01856023|"~     Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic~     melanoma who are treatment naïve or have previously received a single non-immunologic~     therapy.~      Treatment Arm 1: Patients will receive two courses (four cycles) of High Dose Interleukin-2~     (HD IL-2) followed by one course (four doses) of ipilimumab.~      Treatment Arm 2: Patients will receive one course (four doses) of ipilimumab followed by two~     courses (four cycles) of HD IL-2.~      HD IL-2 and ipilimumab dosing regimens will comply with the instructions in the most current~     package inserts, institutional guidelines, and medical expertise of the treating physician.~     However, neither the ipilimumab nor the HD IL-2 should be dose reduced. If necessary, doses~     should be either held or permanently discontinued (per package insert instructions).~     Protocol specific dosing guidance is included in the 12PLK02 Work Instructions.~      Patients will be scheduled for four response assessments. Response assessment timing should~     be targeted to fall within the following time points: between 5-11 weeks, 13-19 weeks, 24-30~     weeks and one year after initiating therapy in either treatment arm. Timing of the response~     assessments may be adjusted to facilitate clinical procedures and treatment decisions.~      Patient treatment tolerability and safety events will be monitored and managed while~     enrolled in the 12PLK02 study. Patients who receive HD IL-2 in the 12PLK02 study will be~     enrolled in the PROCLAIM study (Registry Protocol 10PLK13) for the collection of long-term~     assessment data, including response and disease status and treatment decisions. Patient~     treatment data will be entered in to the PROCLAIM database, for a minimum target of 2 years~     and potentially up to 5 years, after the patient completes the 12PLK02 study.~   "
91769|NCT01856010|"~     Agitation/aggression is one of the most common and serious behavioral complications of~     dementia. If the behavior is refractory to standard care (behavior approaches and off label~     use of psychotropic medications), other evidence based treatment options are not currently~     available. Retrospective reviews and preliminary studies have indicated Electroconvulsive~     Therapy (ECT) may be a safe, effective intervention in this patient population. This study~     will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition,~     mood and psychosis for patients referred for ECT who accept this intervention vs. those~     patients referred for ECT but decline this intervention (i.e. standard care controls). It~     will also assess adverse events, activities of daily living and caregiver burden during~     study participation. The hypothesis is that subjects with dementia related~     aggression/agitation who receive ECT will show significantly greater reductions in these~     behaviors than subjects who do not consent for ECT and continue with standard care. Pine~     Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our~     knowledge, this is the first prospective study to examine whether patients receiving ECT or~     standard care differ in reduction of aggression and agitation symptom severity and changes~     in cognition pre- and post- treatment.~   "
91770|NCT01855997|"~     This Phase 4 study is designed for the collection of blood biomarker samples from~     participants who have completed CHB treatment with at least 24 weeks of a pegylated~     interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment~     follow-up. Participants may be enrolled from historical studies supported or sponsored by~     Roche, ongoing studies supported or sponsored by Roche, or from general medical practice.~     The follow-up of individuals who choose to participate in this study will be in accordance~     with the ongoing studies or with the general medical practice of the physician. Data from~     whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available~     from previously collected Roche Clinical Repository (RCR) samples will be used for combined~     analysis with data from other applicable studies. Procedures will include blood sample~     collection (not applicable for participants who previously have consented and donated RCR~     DNA samples) and medical record capture.~   "
91771|NCT01855984|"~     The purpose of this study is to determine if tocotrienol supplementation given to school~     going children with ADHD will result in reduction of their ADHD symptoms.~   "
91772|NCT01855971|"~     Fragile X syndrome (FXS) present alterations in synaptic plasticity that produce~     intellectual disability. can produce improvement. Estrogens (targeting Estrogen Receptors~     beta (ER-β)can act as neuroprotective agents, promoting synaptic plasticity and neurite~     outgrowth, and health benefits derived from flavonoids, as the flavonol epigallocatechin~     gallate (EGCG), phytoestrogens of natural origin are partially explained by their~     interaction with membrane ER. Selective ER-β flavonoids are thus good candidates for their~     therapeutic evaluation in intellectual disabilities. EGCG also targets central intracellular~     transduction signals altered in FXS and improves memory recognition in a FXS animal~     model(adenosine triphosphate (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and~     mammalian target of rapamycin (mTOR) and extracellular signal-regulated kinase (ERK1/2).~     This study targets the synaptic plasticity alterations that underlie the learning and memory~     impairment but also the computational disability in FXS. The hypothesis is that EGCG can act~     by favoring the physiological processes involved in cognition.~   "
91773|NCT01855958|"~     The aim of this study is to evaluate the cortical excitability in pain of knee~     osteoarthritis (OA), as well as the effect of one session of a kind of electroacupuncture~     (deep needling intramuscular stimulation therapy - DIMST) in this pain and the cortical~     excitability after the intervention.~      The hypothesis is that cortical excitability is altered in this condition, confirming the~     findings already described in other chronic pain conditions. The investigators also believe~     that a session DIMST can reduce pain and alter cortical excitability, restoring its previous~     activity will occur from chronic pain.~   "
91774|NCT01855945|"~     Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in~     children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly~     65 years and older.~   "
91775|NCT01855932|"~     The Enlighten study is an 8-week trial investigating the response to use of a smartphone~     diet and activity application. Participants are enrolled as part of a worksite intervention,~     and will receive the LoseIt! weight loss smartphone application, which requires participants~     to self-monitor dietary intake and physical activity, a component shown to effectively~     produce weight loss. The application will be programmed to deliver dietary intake~     recommendations during the first three weeks of the intervention. At the 3 week time point,~     self-monitoring adherence via the smartphone application will be assessed and those who are~     not responding will receive 4 weekly telephone coaching sessions. Those individuals who~     respond at the end of 3 weeks will be encouraged to continue self-monitoring on the~     application. All participants will also receive regular text messages throughout the trial.~     The importance of the proposed research lies in the objective to reconfigure weight loss~     treatment so as to achieve the intended outcome more efficiently and in a manner that allows~     greater reach.~   "
91776|NCT01855919|"~     The purpose of the study is to assess the efficacy and safety of duloxetine in participants~     with Chronic Low Back Pain (CLBP).~   "
91777|NCT01855906|"~     The purpose of this study is to examine the impact of two surgical techniques on the outcome~     of the knee replacement surgery.~   "
91778|NCT01855893|"~     The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital~     pressure in points of acupuncture) added to the conventional treatment.~   "
91779|NCT01855880|"~     This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose,~     multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque~     psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and~     pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients~     with moderate to severe chronic plaque psoriasis.~   "
91780|NCT01855867|"~     The purpose of this study is to see if an anti-HIV medication known as Stribild~     (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when~     taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune~     Deficiency Virus (HIV).~   "
91782|NCT01855841|"~     ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be~     effective in multiple bilio-pancreatic indications. However, one of the feared complication~     of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient~     groups have been demonstrated to present a higher risk linked to individual factors or to~     the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to~     reduce the incidence of this complication but each has his own inconvenient. Recently, the~     activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been~     demonstrated to be effective in prevention and treatment of acute pancreatitis mice models.~     This protective effect has been associated to intrapancreatic HO-1 positive macrophage~     recruitment activated by hemin. The investigators thus propose to conduct a prospective~     randomized double blind controlled trial to demonstrate a protective effect of hemin~     administration against post-ERCP acute pancreatitis in high risk patients.~   "
91783|NCT01855828|"~     The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the~     anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin)~     concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The~     study will also test the safety of this therapy.~   "
91784|NCT01855815|"~     The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified,~     standard of care data following the commercial use of the Hemolung RAS.~   "
91785|NCT01855802|"~     This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics~     prescription in glaucoma by means of a structured questionnaire.~   "
91786|NCT01855789|"~     This randomized, multicenter, double-blind, parallel group study will evaluate the impact of~     MTX discontinuation on the efficacy of subcutaneous tocilizumab (RoActemra/Actemra) in~     participants with moderate to severe active rheumatoid arthritis who have an inadequate~     response to current MTX therapy. Participants will be initiated on tocilizumab 162~     milligrams (mg) weekly or every 2 weeks, remaining on a stable dose of MTX. At Week 24,~     participants achieving DAS28 less than or equal to (</=) 3.2 will be randomized to either~     continue receiving a stable dose of MTX or to switch to matching placebo until Week 52. In~     the magnetic resonance imaging (MRI) substudy of participants in both treatment arms (MTX or~     placebo), MRI images of hands and wrists will be obtained and analyzed.~   "
91787|NCT01855776|"~     This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable~     walking programme for full-time employees both with and without incentives.~   "
91788|NCT01855763|"~     The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy~     metformin treatment compared with insulin will result in better perinatal and maternal~     outcome and improved treatment acceptability with low or noadditional insulin requirement.~   "
91789|NCT01855750|"~     The purpose of this study is to evaluate if ibrutinib administered in combination with~     rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the~     clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB)~     of diffuse large B-cell lymphoma (DLBCL).~   "
91790|NCT01855737|"~     1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in~          Chinese patients~        2. Drug: Warfarin~        3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm~          calculated dose and actual dose in the Chinese patients.~        4. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in~          Chinese patients.~   "
91791|NCT01855724|"~     The purpose of this study is to determine whether gemcitabine and pazopanib are effective in~     the treatment of inoperable, locally advanced or metastatic biliary tree cancer~     (cholangiocarcinoma or gallbladder carcinoma).~   "
91792|NCT01855711|"~     This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in~     Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and~     (ii) to obtain reference data for endpoints and dosage and administration of a next phase~     study.~   "
91793|NCT01855698|"~     The primary objective of the study is to assess efficacy and safety of different~     prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms~     and platelet count <50 x109/L, including unfractionated or low molecular weight heparin,~     fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants,~     fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial~     or venous thromboembolism managed with observation or use of vena cava filters in patients~     with venous thromboembolism will be included too.~   "
91794|NCT01855685|"~     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects~     boys. It is caused by an error in a gene that makes part of the immune system. The basic~     defect lies in specialised white blood cells called phagocytic cells (or phagocytes), which~     are responsible for protection against infection by destroying invading bacteria and fungi.~     They do this by pouring large amounts of substances similar to bleach onto these organisms.~     In CGD, there is a defect in the system that makes the bleach, called the NADPH-oxidase. In~     X-CGD (which accounts for two thirds of patients), the defect lies in a gene which makes up~     a critical part of the NADPH-oxidase (known as gp91-phox), and the cells cannot make~     bleach-like substances. Therefore they kill bacteria and fungi poorly, and the patients~     suffer from severe and recurrent infections. This also results in inflammation which can~     damage parts of the body such as the lung and gut.~      In many cases, patients can be adequately protected from infection by constant intake of~     antibiotics. However, in others, severe life-threatening infections break through. In some~     cases, inflammation in the bowel or urinary systems results in blockages which cannot be~     treated with antibiotics, and which may require the use of other drugs such as steroids.~     Development of curative treatments for CGD is therefore of great importance.~   "
91795|NCT01855672|"~     The objective of this proof-of-concept study is to generate initial safety and effectiveness~     data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in~     an acute setting. The results of this study will determine if further development of this~     device in a larger study is warranted.~   "
91805|NCT01855542|"~     Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance~     and metabolic acidosis in critically ill patients. The aim of this investigation is to~     compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and~     electrolytes in healthy patients undergoing major spine surgeries.~   "
91796|NCT01855659|"~     Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the~     inspiratory cycle.~      Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary~     disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers~     (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the~     MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are~     available for the administration of inhaled corticosteroids, as well as bronchodilators,~     with each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®,~     Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with~     a consequent airflow across the DPI. This inspiratory flow has to be high enough to~     disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles~     and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory~     flows (PIFs) are not only dependent on a patient's inhalation effort but also on the~     internal resistance of the device.~      It has been shown that optimal deposition of medication with DPIs is not achieved in some~     patients with low inspiratory flow rates, such as children or patients with COPD, especially~     during acute exacerbations. In such conditions the use of a DPI with low internal resistance~     has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition,~     many clinicians are nowadays confronted with an important number of COPD patients who are~     aged >70 yrs~   "
91797|NCT01855646|"~     The overall aim of this project is to improve the quality of the handoffs between~     hospitalists on the general medicine service at Durham Regional Hospital with the intent of~     improving transitions of care. The intervention will be an improved and more structured face~     to face sign-out process using a standardized admission sign-out sheet, which is not part of~     the official medical record. Daytime admitting physicians will assign an acuity score to~     their patients in which the severity of illness will be scored from 1-7, with 7 being the~     most sick / likely to have rapid response team (RRT) or adverse event. The assignment of~     this score would be based off of the clinician's judgment in the patient's overall~     assessment. All patients, age >18 years, admitted to the non-resident hospital medicine~     general medicine service at DRH will be study eligible. Data analysis will examine aggregate~     hospitalist perception of sign-out practice before and after intervention, total number of~     RRTs, unplanned transfers, and rapid responses pre and post intervention, percentage of~     hospitalist based patients of overall rapid responses pre and post intervention, percentage~     of hospitalists using acuity scores, and average and mean severity score of patients with~     rapid responses compared with those admitted. Patients have a risk of loss of~     confidentiality.~   "
91798|NCT01855633|"~     Stroke is one of the major causes of death in the World. Many stroke survivors may suffer~     from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy~     are limited. The development of new treatment strategies is essential. Repetitive~     transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal~     area of the brain for restoring brain function. The aim of this study is to investigate the~     therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.~   "
91799|NCT01855620|"~     Two-thirds of young women in the United States are overweight or obese. This excess weight~     may affect how their body metabolizes drugs such as different birth control methods. There~     is a not a lot of research about how excess weight could affect the hormone levels of the~     contraceptive implant. Methods like the implant contain only progesterone, which is a~     hormone that does not increase a woman's risk of blood clot. These methods would be~     preferred for overweight and obese women because excess weight also increases a woman's risk~     of blood clot.~      The investigators propose a study comparing blood hormone levels of women using the implant~     for at least twelve months and in all weight categories. The investigators hope to show that~     all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.~   "
91800|NCT01855607|"~     To assess whether six week treatment with twice a day topical Menthol application will~     decrease persistent neuropathic pain from chemotherapy among breast and colorectal cancer~     patients.~   "
91801|NCT01855594|"~     To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of~     patients with spinal cord injury.~   "
91802|NCT01855581|"~     Sedation and anesthesia for diagnostic imaging represents a rapidly growing field of~     practice, especially in children. Propofol is the most common sedative drug administered for~     MRI/CT. However, this drug is associated with adverse events, including pulmonary~     complications, and there has been no report on these complications in Korea.~      The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between~     January and November 2012.~      In this study, the investigators will report the nature and frequency of adverse events~     associated with sedation for MRI/CT between January and November 2012.~   "
91803|NCT01855568|"~     Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality.~     Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths~     in the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic~     pregnancy. The main stays of management for ectopic pregnancy were surgery and medical~     treatment. Medical management with systemic methotrexate administration avoids the inherent~     morbidity of anesthesia and surgery is cost-effective, and also offers success rates~     comparable to surgical management, with no loss in future potential fertility.~      However, although medical management using methotrexate is used commonly, there is no solid~     consensus regarding dose protocol. Currently, there are three methotrexate protocols for the~     treatment of an ectopic pregnancy, multi-dose, single-dose, or two-dose. Among them,~     the multi-dose protocol includes the administration of 4 methotrexate doses alternating with~     leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side~     effects are more common. In contrast, the advantages of the single-dose protocol include~     elimination of a rescue regimen, lower incidence of adverse effects, and better compliance.~     However, the single-dose protocol was found to be associated with a considerably lower~     success rate as compared with the multi-dose protocol (88% versus 93%) in a recent~     meta-analysis. The two-dose protocol, which it balances efficacy and safety/convenience, was~     described as a cross between the multi-dose and single-dose protocols.~      However, there were a few studies comparing between single-dose and two-dose protocol. The~     purpose of this prospective randomized trial was to compared the success rates of~     single-dose and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.~   "
91806|NCT01855529|"~     After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and~     68%. They begin after surgery and may persist until more than 6 months. They respond poorly~     to opioid analgesics impair the quality of life.~      Among the different postoperative analgesic techniques used, the use of a local anesthetic~     infiltration continues catheter has advantages including improving the quality of analgesia,~     with a significant decrease in average of VAS (scale visual Analogue), a decrease in~     morphine consumption, improving the quality of life of patients.~      Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration~     in the control of postoperative pain after mastectomy.~   "
91807|NCT01855516|"~     This study is designed to assess: the incidence of abnormal partial thromboplastin time in~     patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day 72~     hours after administration of the first dose of heparin.~      Hypothesis: The basic hypothesis of this study is that patients receiving UFH 5000 U~     subcutaneously 3 times a day will have a higher proportion of elevated partial~     thromboplastin time than patients receiving UFH 5000 U subcutaneously twice a day.~   "
91808|NCT01855503|"~     This is a molecular testing study for patients with metastatic breast cancer. The purpose of~     this study is to find defects in the DNA of the cancer that could potentially be treated~     with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if~     your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation~     is a change int he DNA sequence of a gene) that makes this receptor superactive a drug~     that inhibits this receptor may also inhibit the growth of the cancer. If this genetic~     defect is not present in the cancer the same drug may not work. This EGFR gene mutation~     based patient selection for treatment has worked in lung cancer and we are testing its value~     in breast cancer. What drugs may be available against particular genetic abnormalities in~     the context of this clinical study will change over time.~   "
91809|NCT01855490|"~     The study is designed as an open labeled pilot trial to analyze the acute responses of~     glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or~     intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide~     (Byetta) 5 mcg sc.~      The investigators will also test the effects of Exenatide on gastric emptying during the~     MMTT.~   "
91810|NCT01855477|"~     A major challenge for researchers in cancer care is to expedite the development of new~     therapeutics and the Center for Personalized Cancer Treatment (a collaboration of the Dept.~     of Medical Oncology from the University Medical Center Utrecht, Netherlands Cancer Center -~     Antoni van Leeuwenhoek hospital and the Erasmus Medical Center - Daniël den Hoed clinic) is~     an initiative to achieve this goal.~      The current and future generation anti-cancer drugs are developed to specifically activate~     or deactivate deregulated gene products or signaling pathways in cancer cells. The~     development of such targeted agents is an exciting new opportunity that promises to~     deliver more anti-cancer efficacy and less toxicity. Although targeted therapy has been a~     breakthrough in medical oncology leading to the development of a portfolio of potentially~     successful new drugs, it has not yet delivered the much needed relief for large patient~     populations. We believe that the development of these agents is mainly hampered by our lack~     of successful patient selection.~      The CPCT aims to select patients for clinical trial participation based on the results of~     Next Generation Sequencing (NGS) information obtained from tumor material. The advent of NGS~     platforms enables us to probe a significant proportion of the cancer genome and thus to~     develop a realistic view on the complex genetic changes in cancer cells. The CPCT aims to~     use NGS platforms to improve the selection of patients for targeted therapy trials.~      We will obtain tumor biopsies of a (preferably) metastatic or locally advanced lesion and~     peripheral blood sample from all patients included in the trial; the biopsies to obtain~     information on the tumor related genetic mutations (mutational profile) and the blood~     samples to assess each patient's germline DNA background variation. As patients will be~     asked to undergo an invasive procedure it is important to address the potential safety~     issues. Review of the literature shows that in general tumor biopsies can be performed with~     only minor complications and acceptable risks. We will recruit patients with metastatic or~     locally advanced (incurable) solid tumors and we aim to use the information obtained from~     DNA sequencing to stratify patients for inclusion in clinical trials. The final personalized~     treatment decision will be made dependent on the availability of trials and the expected~     predictive value of the mutational profile.~   "
91811|NCT01855464|"~     Primary spontaneous pneumothoraces (PSP) represent a significant public health problem,~     occurring in young healthy subjects without pre-existing lung disease or precedent medical~     intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP~     treatment often requires thoracic surgery to restore lung expansion and to prevent de novo~     lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society~     (BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP),~     the majority of German hospitals gathered experience especially in limiting surgery to~     cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until~     today, hardly any reliable data exist to analyze and compare the varying treatment~     approaches regarding efficacy and efficiency. In this randomized, multi-centric clinical~     trial, both treatment approaches will be compared. For this purpose, candidates for surgery~     will be randomized into one of the two treatment groups after informed consent has been~     obtained. Patients will be followed for 2 years by the participating centres to be able to~     evaluate the long-term effect of the surgical interventions.~   "
91812|NCT01855451|"~     A standard treatment for patients with head and neck cancer is radiation given with high~     doses of a chemotherapy drug called cisplatin, given every 3 weeks during the radiation.~     This treatment is effective but can significantly increase side effects such as difficulty~     with swallowing, a sore mouth, fatigue, hearing loss, ringing in the ears and kidney~     failure. In Australia, a commonly used treatment HPV-Associated Oropharyngeal Squamous Cell~     Carcinoma is a lower dose of cisplatin given weekly during the radiation. The high dose and~     low dose schedules result in a similar total dose of cisplatin being given during the~     radiation, but it is thought that the weekly schedule results in fewer side effects while~     maintaining effectiveness.~      Another approach widely used around the world for patients with head and neck cancer, is to~     administer the antibody, cetuximab, weekly during radiation. Cetuximab has a very different~     side effect profile to cisplatin, and has been reported to result in less exacerbation of~     radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a~     cancer and increase the effectiveness of radiation. Both cisplatin and cetuximab appear to~     be effective treatments in combination with radiation, but have not been directly compared.~      The purpose of this study is to compare the treatment related side effects (both acute and~     longer term) between the cisplatin and cetuximab regimens. Both treatments would be given~     with the same dose of radiation therapy over 7 weeks. The results of this trial will help~     determine the optimal treatment for patients with HPV-Associated Oropharyngeal Squamous Cell~     Carcinoma.~   "
91813|NCT01855438|"~     This study will test the efficacy of a communication intervention intended to increase and~     improve kidney transplant candidates' communication about live donor kidney transplantation.~   "
91816|NCT01855399|"~     Peer support programs have been demonstrated to improve glycemic control among Veterans with~     poor control. This program will expand on this success by putting innovative tools in the~     hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control~     of their own diabetes will be trained to use communication skills to guide their peers~     through a diabetes education and decision aid. This tool, which is an iPad application,~     draws the patient in by showing them their personal risk and medication information derived~     from baseline labs and self-reported survey data. The tool encourages interaction by~     providing choices of materials to view, using audio-visual elements and incorporating a~     goal-setting process for developing self-management action steps and questions to discuss~     with their doctor at their next clinic visit. Ongoing weekly contact between the Veterans is~     supported by a confidential phone system.~   "
91817|NCT01855386|"~     The thought is that Non-Alcoholic Fatty Liver Disease (NAFLD) plays a key role in the~     progression to prediabetes/T2DM in those with a history of Gestational Diabetes (GDM). The~     investigators want to know if having a fatty liver will be connected with more glucose~     abnormalities (higher fasting/oral glucose tolerance test glucose, more insulin resistance)~     and that a history of GDM will be common in those with NAFLD.~   "
91818|NCT01855373|"~     To purpose of this study is to assess the effectiveness, safety and tolerability of PEAK~     ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn® on levels of blood sugar and endothelial~     function improvement which may lead to improved vascular health.~   "
91819|NCT01855360|"~     The objective of the study is to determine whether the combination of the bile acid TUDCA,~     and doxycycline will slow the progression of familial and senile amyloidosis.~   "
91820|NCT01855347|"~     There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature~     infant population, principally those with associated risk like extreme prematurity, extreme~     low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia)~     and those born in hospitals with limited resources for optimal neonatal care.~      Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in~     cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen~     delivery.(3) In the premature patient population, many neurologic injuries occur as a result~     of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been~     focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin~     tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to~     validate NIRS measurements and have established normative data.(4-6) The non-invasive method~     of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care~     units in patients at risk for neurological injuries. This method has been successfully~     validated to monitor neonatal cerebral oxygenation in different clinical settings and study~     protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and~     oxygen dynamics.~      One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis.~     It is important to monitor not just cerebral perfusion but also the intestinal~     oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change~     their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed~     NIRS in premature piglets to demonstrate association of perfusion change with NEC~     spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool~     in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of~     detecting alterations in intestinal oxygenation and perfusion.~      In summary, a-NIRS could be use in the premature infant population to define reference~     values, especially in patients at risk, which would then facilitate the early diagnosis of~     NEC spectrum diseases.~   "
91821|NCT01855334|"~     Cardiovascular disease is the primary cause of death in patients with end stage renal~     disease (ESRD). New research suggests that the high risk of death may be partly due to high~     levels of fibrosis and a loss of small blood vessels in the heart of patients with~     dialysis-dependent ESRD. This study is designed to compare the effects of two different~     drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in~     individuals with dialysis-dependent ESRD.~   "
91822|NCT01855321|"~     This pilot study will investigate the effect of Vitamin D supplementation in improving~     glucose control with patients with poorly controlled diabetes and concurrent Vitamin D~     deficiency.~   "
91823|NCT01855308|"~     This is a study of new technology to allow gallbladder removal through a single small~     surgical incision. A surgical robot is utilized to help navigate the small space. In this~     study, patient characteristics are broad to assess how applicable the procedure is to~     everyone.~   "
91824|NCT01855295|"~     Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum~     albumin is a strong predictor of morbidity and mortality in dialysis patients.~     Hypercatabolism induced by inflammation is widely considered the cause of uremic~     malnutrition even though there is no clear evidence that hemodialysis patients with elevated~     C-reactive protein (CRP) levels are at greater risk of losing weight or muscle mass.~     Conversely, there is little data on whether dialysis patients with malnutrition and elevated~     C-reactive protein levels would gain muscle mass with protein supplementation.~      The hypothesis is that protein supplementation during dialysis will improve muscle mass,~     functional status and quality of life in inflamed malnourished hemodialysis patients.~     Therefore, the objectives of the current proposal are to examine in malnourished (body mass~     index < 23 kg/m2 or serum creatinine < 8 mg/dL) hemodialysis patients with inflammation~     (high sensitivity CRP > 3 mg/dL), the effects of protein supplementation on~        1. Muscle mass as determined by creatinine kinetics~        2. Functional status as assessed by 6 min walk~        3. Quality of life as assessed by Short Form -12 survey~   "
91825|NCT01855282|"~     This is a study to assess the effectiveness of a culturally appropriate behavioral~     intervention to reduce obesity levels and ultimately the risk of developing diabetes type II~     in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into~     an intervention or control arm of the study. The intervention participants received weekly~     classes for 10 weeks with education on diabetes, diet and physical activity and practical~     exercises. Both control and intervention were measured for weight, waist circumference,~     fasting blood glucose and interviewed before and after the study intervention. The main~     hypothesis was that intervention, but not control participants, would experience reduction~     in body measurements after the intervention.~   "
91826|NCT01855269|"~     The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a~     prospective randomized controlled study would improve symptoms of infantile colic.~   "
91827|NCT01855256|"~     Evaluation of the effectiveness of oxybutynin in hyperhidrosis~   "
91841|NCT01855074|"~     The purpose of this study is to evaluate the efficacy and safety of long acting injectable~     microspheres of risperidone in participants with schizophrenia (psychiatric disorder with~     symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders~     (disorders in which there is a loss of ego boundaries or a gross impairment in reality~     testing with delusions or prominent hallucinations).~   "
91828|NCT01855243|"~     Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus~     modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens~     for glycemic control in hospitalized diabetic patients with diabetes.~      Methods: In a prospective trial, patients with diabetes will be randomized to receive either~     traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin~     for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥~     150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day~     for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.~   "
91829|NCT01855230|"~     The purpose of this study is to evaluate the safety, tolerability, and clinical activity of~     ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or~     GOLD 3 COPD.~   "
91830|NCT01855217|"~     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight~     or the ideal body weight?~      To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg~     IBW versus 1 mg/kg TBW versus placebo.~   "
91831|NCT01855204|"~     Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing~     lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. The purpose~     of our study is to compare images of CT urography performed by low voltage and low~     concentrated iodine CT contrast with them of conventional CT urography.~   "
91832|NCT01855191|"~     Introducing standardized data collection (SDC) for lung cancer patients to improve the~     performance of the prediction models.~   "
91833|NCT01855178|"~     Nocturnal seizure and Sudden unexplained death in epilepsy patients (SUDEP) are major~     concerns for parents and creates anxiety and poor sleep conditions for many families dealing~     with epilepsy. An accurate and reliable system for alerting parents to ongoing seizure~     activity could make a substantial impact in quality of life and possibly reduce the~     mortality of epilepsy. No previous studies in the pediatric population have been performed~     to evaluate this type of monitoring for seizure activity. This is one of the most common~     questions parents ask in clinic, Are there any alarms that can tell me when my child is~     having a seizure at night? Currently the answer is no. This study has the capability to~     give us data that may change this answer to yes.~   "
91834|NCT01855165|"~     Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and~     their incidence increases with the number of drugs that the patients are prescribed for~     treatment of their condition. Data bases often detect DDIs that are of high clinical~     relevance. The investigators have performed this study in order to detect clinically~     significant DDIs and to diminish their occurrence by sending notification about DDIs to~     attending physician.~   "
91835|NCT01855152|"~     800,000 people in the United Kingdom (UK)have dementia, of which 250,000 are living in care~     homes. These individuals have complex mental health problems, disabilities and social needs,~     which if unmet will continue to adversely affect each individual, as well as the main goal~     of enabling people to live well with dementia, as presented in the National Dementia~     Strategy (NDS) (Department of Health, 2009).~      This optimized intervention WHELD is based on a factorial study and qualitative evaluation~     designed to facilitate the design of this current study and will combine this with the most~     effective elements of existing approaches to develop a comprehensive but practical~     intervention to improve quality of life in persons with dementia living in care homes. The~     intervention will combine training on person centred care, promoting person centred~     activities and interactions and provide care home staff and general practitioners with~     updated knowledge regarding the optimal use of psychotropic medications for persons with~     dementia in care homes.~      The overarching goal of this trial is to determine whether this optimised WHELD intervention~     is more effective in improving the quality of life and mental health, than the usual care~     provided people with dementia living in nursing homes. The cost effectiveness of the~     intervention will be assessed as well, with the aim to provide a cost effective, simple and~     practical intervention, improving quality of life and mental health of people with dementia~     in care homes; which can be rolled out nationally to all UK care homes as an National Health~     Service (NHS) intervention. The trial will be a randomised controlled 2-arm cluster single~     blind trial that will take place for 9 months across 80 care homes in UK.~   "
91836|NCT01855139|"~     The objective of this NIS is to assess in a real-life setting, usage patterns and associated~     outcomes in the management (healthcare resource utilisation and associated costs) of~     patients with non-valvular AF treated with Xarelto, in accordance with the terms of the~     European marketing authorization and the Belgian reimbursement criteria.~   "
91837|NCT01855126|"~     In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research,~     University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a~     low-cost, minimally obtrusive device that delivers individualized light therapy to adults~     with early-awakening insomnia - the most common sleep disturbance in older adults, and a~     significant problem because of its relationship to daytime sleepiness, use of potentially~     hazardous sleep medication, and reduced quality of life. The proposed device will measure~     light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and~     deliver an individualized light dosage while subjects are asleep. Light applied through~     closed eyelids in the early part of the night will delay the dim light melatonin onset, a~     marker of the circadian clock, and help those with early sleep onset to fall asleep later~   "
91838|NCT01855113|"~     This study aims to compare the pain experienced by patients undergoing orthodontic treatment~     with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment~     with conventional braces. Because the aligners are removable, nearly invisible and don't~     involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign~     Treatment and less affectation of the quality of life.~   "
91839|NCT01855100|"~     The objective of this NIS is to assess in a real-life setting, usage patterns and associated~     outcomes in the management (healthcare resource utilisation and associated costs) of~     patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms~     of the European marketing authorization and the Belgian reimbursement criteria.~   "
91840|NCT01855087|"~     There is paucity of information about the combination therapy with dipeptidyl peptidase-4~     inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the~     safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.~   "
91849|NCT01854970|"~     Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the~     larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very~     changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect~     these reflux and to identify patients with abnormal LPR.~      To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients~     with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.~   "
91850|NCT01854957|"~     A double-blind, randomized, cross-over phase I/II study to evaluate the safety and the~     efficacy of the intravenous administration of autologous Mesenchymal Stem Cells (MSC) to~     patients with active multiple sclerosis (MS) resistant to currently available therapies.~   "
91851|NCT01854944|"~     The purpose of this study is to determine how low and high does of brexpiprazole binds to~     certain receptors in the brain. This will be determined by PET scans taken pre-dose and~     post-dose.~   "
91852|NCT01854931|"~     The overarching objective of this project is to assess the potential public health impact of~     delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through~     local community dissemination partners (e.g., senior service providers), in the selected~     counties in the state of Oregon.~   "
91853|NCT01854918|"~     This study will contribute to the evaluation of long-term safety, tolerability and efficacy~     of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed~     dyslipidemia.~   "
91854|NCT01854905|"~     This is an observational, study of dry eye in patients at the consultation visit prior to~     LASIK surgery. There is no treatment administered or intervention during the study.~   "
91855|NCT01854892|"~     Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts~     for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will~     experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will~     develop chronic pain and related disability.~      While there is growing evidence for the clinical effectiveness of alternative and~     complementary therapies to treat low back pain, little is known on the physiologic~     consequences and effects of these treatments. Further, additional data is needed to~     understand how these different treatment techniques effect clinical changes in pain and~     disability. The lack of empirical data hinders acceptance by the wider scientific and~     health-care communities, and it also limits the development of rational strategies for using~     alternative and complementary therapies.~   "
91856|NCT01854866|"~     Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer.~     Currently, the management of malignant ascites and pleural effusion is a considerable~     clinical challenge. The investigator hypothesized that tumor cell-derived microparticles~     packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and~     pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited~     for Phase II clinical trials.~   "
91857|NCT01854853|"~     Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk~     behaviors than those in the general population. In Brazil, among youth seeking HIV testing,~     those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk~     reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT~     in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for~     adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents~     is not available in Brazil; this application targets this need.~      Using quantitative and qualitative methods we will explore the contextual influences on~     sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention~     adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad)~     intervention HIV, STI and pregnancy prevention intervention with a sample of male and female~     youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites~     in preparation for the RCT.~   "
91858|NCT01854840|"~     Primary purpose: to study the relationship between betamethasone placental transfer and the~     occurrence and severity of the Hyaline Membrane Disease.~   "
91859|NCT01854827|"~     The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a~     clinical trial to determine the feasibility, acceptability, tolerability and safety profile~     of IVIG treatment administered to infants after hepatic portoenterostomy (HPE) for biliary~     atresia, as well as investigate preliminary evidence of activity and explore mechanisms of~     action.~   "
91860|NCT01854814|"~     The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on~     time to doubling of serum creatinine or the onset of end stage renal disease in patients~     with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of~     losartan.The study will also assess the effects of MMF compared with losartan alone on the~     changes of urine albumin excretion and the changes in estimated glomerular filtration rate.~   "
91861|NCT01854801|"~     The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual~     medical care of electro-sensitive patients: by measurement of health status, sensitivity to~     electromagnetic fields exposures, and quality of life.~   "
91862|NCT01854788|"~     Study design: a randomized, crossover trial. Each patient performed three different airway~     clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral~     posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy~     degree in a randomized order. Each technique were applied in 3 sessions during one week at~     alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in~     each bronchial session was 40 minutes. Seven days were the wash-out time period between the~     different techniques.~   "
91863|NCT01854775|"~     There will be 2 cohorts in this study, each consisting of Part A and Part B.~      The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK)~     for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet~     regimen (STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through~     Week 24 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.~      The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically~     suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered~     E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through~     Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing~     ≥ 25 kg.~   "
91864|NCT01854762|"~     The current available antiretroviral (ARV) agents make possible a successful treatment of~     virtually all HIV-infected patients, even those heavily experienced subjects, with a history~     of previous failure to ARV drugs of different classes. However, some problems are still~     present, especially for specific populations, like pregnant women and infants. For these~     groups, most of currently available drugs are not used, because the lack of information on~     safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child~     transmission (MTCT) is still a problem in certain areas of the world, especially in~     resource-limited settings. In some settings, women often present to their first antenatal~     care visit late in the pregnancy, posing an additional problem: how to effectively treat~     these patients to assure they will have an undetectable viral load at the moment of~     delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take~     6 or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA~     / ml of plasma. To achieve this goal, it would be necessary the use of a potent, very~     efficacious ARV regimen that could provide such viral decay in a very short period.~     Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The~     available evidence suggest it has no genotoxic potential, and promotes a rapid decline in~     HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting~     different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to~     be used for prevention of MTCT for women with detectable viral load, presenting late in the~     course of pregnancy. Another attractive point is to consider that, due to the similarity~     between the integrase enzyme of HIV-1 and HTLV; RAL could be active against HTLV-1, blocking~     its replication. If our hypothesis is correct, the use f RAL-containing ARV regimens would~     reduce the MTCT of both agents. This study has the objective of evaluating the efficacy of~     RAL containing ARV regimens in reducing the HIV-1 RNA plasma viral load below 50 copies/ml,~     at the end of pregnancy, for late-presenters pregnant women and to compare the frequency of~     adverse events for women using RAL-based ARV regimens and comparators, and for their babies.~   "
91865|NCT01854749|"~     Assess the efficacy and safety of S1 combined with cisplatin in treatment of~     recurrence/metastasis of ESCC~   "
91866|NCT01854736|"~     This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled,~     national, single-centre trial.~      The trial will be initiated before 2013 grass pollen season and subjects will be randomised~     in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo~     group will be treated 2 years with placebo and a third year with active therapy (Grazax®)~     and active group will continue the active treatment in the third year. In the last year, all~     placebo patients will be changed to active group and active and placebo patients will be~     informed about, but the trial will not be unblinded until the end of the third year and~     patients won´t know what treatment they were assigned to during the first 2 years.~   "
91867|NCT01854723|"~     This study will compare the safety, effectiveness, and cost of two different types of~     long-acting insulin.~   "
91868|NCT01854710|"~     It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation~     does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc~     prolongation following repeat dosing is unknown. Therefore the current study will assess the~     potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours~     apart, in relation to placebo and an active control in healthy volunteers.~      The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec~   "
91869|NCT01854697|"~     This is a study to evaluate the efficacy and safety of three experimental drugs compared~     with telaprevir (a licensed product) in people with hepatitis C virus infection who have not~     had treatment before.~   "
91870|NCT01854684|"~     This phase I trial studies the side effects and best dose of photodynamic therapy during~     surgery in treating patients with non-small cell lung cancer that can be removed by surgery.~     Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed~     to a certain kind of light. When the drug is active, cancer cells are killed. This may be a~     better way to treat patients with non-small cell lung cancer.~   "
91871|NCT01854671|"~     The purpose of this study is to measure the difference in proportion of postpartum women~     using contraception after a Community Health Worker (CHW) family planning educational~     intervention compared to women who receive standard care in the West Bank district of~     Ramallah and Al-Bireh.~      Primary hypothesis: Postpartum contraceptive use will increase in women who receive a~     dedicated family planning counseling intervention delivered by CHWs during antenatal care~     compared to women receiving usual care.~   "
91872|NCT01854658|"~     This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks),~     placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and~     Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI~     (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very~     severe COPD.~   "
91873|NCT01854645|"~     The overall objective of this study is to assess the efficacy and safety of treatment with~     PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide~     inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with~     moderate to very severe COPD.~   "
91874|NCT01854632|"~     This study will provide the Senegal Ministry of Health with data on the clinical efficacy of~     the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy~     considerations for influenza vaccine.~   "
91875|NCT01854619|"~     The purpose of this study is to determine whether the use of light and a topically applied~     photosensitizer can relieve symptoms and clinically improve patients with chronic~     rhinosinusitis.~   "
91876|NCT01854606|"~     Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or~     ABC subtype Diffuse Large B-Cell Lymphoma~   "
91877|NCT01854593|"~     We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular~     tissue and whole body, intravitreal injection of a low concentration of bevacizumab and~     conducting vitrectomy shortly after the injection is useful. In the present prospective,~     double-masked, randomized, controlled study, we aimed to verify the usefulness of~     intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy~     for PDR.~   "
91878|NCT01854580|"~     The purpose of the study is to investigate the effectiveness and cost-effectiveness of the~     integrated care program of a statutory health insurance offering additional homeopathic~     treatment to their members~   "
91879|NCT01854567|"~     The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in~     patients with hematologic malignancies undergoing transplantation with myeloablative~     conditioning.~   "
91919|NCT01854047|"~     Primary Objective:~      To evaluate the efficacy of different doses and regimens of dupilumab in patients with~     moderate to severe uncontrolled asthma~      Secondary Objective:~      To evaluate different doses and regimens of dupilumab in patients with moderate to severe~     uncontrolled asthma, with regard to:~        -  Safety and tolerability~        -  Dupilumab systemic exposure and anti-drug antibodies~   "
91880|NCT01854554|"~     The goal of this clinical research study is to compare IMRT with IMPT in patients with~     glioblastoma. Researchers want to learn about cognitive side effects (mental status changes)~     that may occur, such as memory loss and impaired thinking.~      IMRT is the delivery of focused radiation therapy using photon beams and advanced computer~     planning to help shape the dose in order to give the highest possible dose to the tumor with~     the least dose to surrounding normal tissues.~      IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to~     deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in~     order to shape the dose to the target with the least dose to surrounding normal tissues.~   "
91881|NCT01854541|"~     The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize~     and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be~     done by the introduction of models that can predict a patient being at risk for waiting too~     long as well as visual management tools that visualize the radiotherapy process.~   "
91882|NCT01854528|"~     The purpose of this study is to evaluate the safety and antiviral activity of 3~     direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267~     also known as ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV)~     compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients~     with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were~     previously treated with pegylated interferon/ribavirin (pegIFN/RBV).~   "
91883|NCT01854515|"~     The present study was aimed at investigating the efficacy of nebulizing Budesonide sin~     comparison with intravenous Dexamethasone before extubation in prevention of post-extubation~     complications amongst patients admitted in intensive care unit.~      In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who~     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in~     the study after obtaining a written informed consent from their parents or guardians.~      The investigators divide our patients randomly into two equal groups.~      -In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose~     of 1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation.~     After extubation patients received nebulizing budesonide via oxygen mask at the same dose~     every 12 hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered~     to patient at a dose of 0.15 mg/kg before extubation. After extubation, the administration~     of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.~      Another anesthesiologist who is unaware about kind of medication, will evaluate the patients~     for severity of stridor. We will record the vital sings and grade of stridor every 6 hour.~     Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2)~     were recorded for each patient immediately before aerosol administration (time 0) and at 30~     and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor~     (heard with the aid of stethoscope) was recorded within 48 hr of extubation~   "
91884|NCT01854502|"~     The purpose of this study is to compare the effects of two new family-based oral health~     promotion programs with the routine program in use earlier in Vantaa public dental service.~     The children born in 2008 were followed from their first visit to public dental service at~     the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome~     measures are the colonization of mutans streptococci in dental plaque, dental caries, and~     the oral health habits of two-year-olds.~   "
91885|NCT01854489|"~     This study is aimed to examine the possible interactions of sublingual and intravenous~     buprenorphine with rifampicin.~   "
91886|NCT01854476|"~     Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable~     the insertion of two large gauge needles. At the end of dialysis the needles are extracted~     and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is~     different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on~     chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including~     uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or~     anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid~     (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss~     at different clinical settings. The drug may be given systemically (PO/IV) or applied~     locally on the site of injury.~      The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing~     tranexamic acid.~      Study design:~      A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular~     pad-gauze. The type of dressing for each dialysis session will be decided in a random~     manner. In each dialysis session only one type of dressing will be used for both insertion~     points.~      Protocol for applying the dressing:~      Following the needle extraction either dressing A or B will applied with slight pressure~     for 2 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than another dressing of the same kind is applied with slight pressure~     for 4 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than another dressing of the same kind is applied with slight pressure~     for 6 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than it will be consider a failure and a regular measures will be used~     until bleeding stops.~      Each session will be documented in the patient's case report file (CRF). The primary end~     point of the study: Time to bleeding cessation~   "
91887|NCT01854463|"~     In many observational studies, vitamin D deficiency is related to glucose intolerance and~     diabetes. But there little randomized, controlled interventional studies that evaluate the~     effect of vitamin D in type 2 diabetes.~      Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2~     diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and~     bone turnover markers.~   "
91888|NCT01854450|"~     Maternal posturing is used during labor to facilitate the rotation of occipitoposterior~     fetal position in anterior.~      Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of~     the fetal head.~   "
91889|NCT01854437|"~     Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for~     control of Hyperphosphatemia are used. The aim of this study was to assess the effect of~     magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of~     its side effects in hemodialysis patients.~   "
91890|NCT01854424|"~     Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and~     associated with outcome in different diseases. In previous study, we have demonstrated the~     presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their~     association with patient outcome. The purpose of this multicentric observational prospective~     study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS~     (survivors vs. non survivors) and to confirm their association with 28-day mortality.~   "
91891|NCT01854411|"~     The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into~     mature breastmilk that could allowed breastfeeding during a long time~   "
95315|NCT01809522|"~     The present study is a multicenter randomized, controlled trial, whose aim is to verify the~     effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical~     prostatectomy on early recovery of urinary continence.~   "
91892|NCT01854398|"~     The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been~     reported, and improvement of diastolic function after continuous positive airway pressure~     (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function~     by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that~     3 months of CPAP therapy in OSA patients will significantly improve diastolic functional~     parameters measured by exercise stress echocardiography. Patients with severe OSA~     (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus~     sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity,~     24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP~     therapy and parameters will be compared.~   "
91893|NCT01854385|"~     This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH)~     will examine the methods and approach necessary to take the next step to a phase III trial.~     The sample will include 40 persons with mild complicated, moderate or severe TBI who will be~     recruited from patients discharged from the acute rehabilitation unit as well as outpatient~     clinics and the community who are between 3 and 24 months of injury and will be followed~     over 3 months. The investigators plan to enroll those who have moderate to severe headache~     with frequency of at least four and up to a maximum of fifteen total headache days per month~     and at least three months after discharge from hospital. The investigators will use headache~     diaries to track the headaches for a month. If subjects still have significant headache, the~     investigators will instruct them in the use of sumatriptan 100 mg. to treat headaches. The~     subjects will continue to keep daily headache diaries. The investigators will evaluate them~     at baseline, Day 30 and Day 90. Each subject will receive weekly telephone follow up calls~     from the research staff. The investigators will measure pain severity, duration, recurrence~     of headaches, and side effects and how well persons with TBI can use headache diaries.~   "
91894|NCT01854372|"~     To estimate the I-year progression-free survival probability in patients up to 70 years of~     age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate~     (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with~     alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert~     with optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and~     close clinical follow-up.~   "
91895|NCT01854359|"~     Background:~      - The Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS) trial~     tested a new drug for multiple sclerosis. In the IPPoMS trial, participants took either~     idebenone or placebo. Researchers want to give idebenone to all participants for 1 year. It~     is still not certain whether idebenone can slow the progression of multiple sclerosis, but~     this study may help answer that question.~      Objectives:~        -  To provide idebenone to all participants on the IPPoMS trial.~        -  To collect data on the safety and effectiveness of idebenone for primary progressive~          multiple sclerosis.~      Eligibility:~      - Individuals at least 18 years of age who have completed 3 years in the IPPoMS trial.~      Design:~        -  The first study visit for this trial will happen on the same day as the last visit for~          the IPPoMS trial.~        -  Participants will provide a blood samples and will have a lumbar puncture. They will~          also receive a new supply of idebenone to take three times a day with food. They will~          keep a diary to report on any side effects.~        -  After this first treatment visit, participants will have two follow-up visits to the~          NIH 6 months apart. These visits may be scheduled over multiple days. Participants will~          provide blood and urine samples. They will also have imaging studies of the brain and~          spine.~        -  Participants will have phone calls with the study researchers to provide updates on~          their condition and any side effects.~   "
91896|NCT01854346|"~     This trial investigates the behavioral effects of manualized social skills training~     (KONTAKT) in children´s and adolescents with high-functioning autism spectrum disorder with~     psychiatric comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and~     adolescent psychiatric clinics in Stockholm County. The examination of genetic variants as~     predictors for outcome and a qualitative study of KONTAKT complete the trial.~   "
91897|NCT01854333|"~     Autism spectrum disorders (ASD) are early onset chronic conditions coined by deficits in~     social reciprocity, communication and stereotypic interests and activities. Other functional~     impairments such as mental retardation, ADHD, known genetic syndromes and epilepsy are~     frequent coexisting problems. ASD cause considerable suffering for the affected individuals~     and burden for their families. With an estimated prevalence exceeding 1%, recent~     population-based studies suggest that ASD are no rare phenomena. Lifetime societal costs for~     services and support, together with the opportunity costs of lost productivity in a~     prototypic developed country are estimated SEK 15.6 million for someone with and SEK 10.3~     million for a person without co-existing mental retardation. Despite ongoing efforts, no~     diagnostically informative biomarker has yet been identified for ASD. The development,~     refinement and evaluation of behavioral assessment tools has therefore been decisive to~     progress and quality assurance in ASD clinical practice and research. The most widely used~     and thoroughly evaluated instruments for ASD in international child mental health are the~     Autism Diagnostic Interview- Revised (ADI-R) and the Autism Diagnostic Observation Schedule~     (ADOS). The ADI-R and ADOS are deemed highly by the ASD expert community and thus commonly~     labeled as being the gold standard in ASD diagnostics. Although, Swedish translations of~     the ADI-R and ADOS exist, a Swedish standardization and cross-cultural validation is still~     lacking, impeding good clinical practice and research prerequisites for ASD in Sweden. The~     applied project seeks to broadly establish reliability and validity of the Swedish~     translations of the ADI-R and ADOS in order to enhance evidence-based clinical practice and~     stimulate internationally competitive ASD research in Sweden.~   "
91898|NCT01854320|"~     The primary goal of this project is to determine if an innovative behavioral weight loss~     program that incorporates new developments from the field of behavior therapy produces~     superior weight control than standard behavioral treatment. A sample of 200 adults from the~     community are participating in this study.~   "
92055|NCT01852279|"~     This study will assess whether functional recovery of the hand muscles in patients with~     spinal cord injury is enhanced when electrical stimulation of the muscles is delivered~     actively by means of using the electroencephalography wave patterns arising from the patient~     imagining moving their hand to operate the stimulator. A control group will obtain the~     electrical stimulation treatment passively by a therapist operating the machine.~   "
91899|NCT01854307|"~     Perioperative goal directed fluid therapy may reduce complication rate after surgery.~     Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More~     operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the~     abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence~     minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not~     recommended during laparoscopy. This study aims to validate minimal cardiac output~     monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.~   "
91900|NCT01854294|"~     GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that~     controls the development, monitoring and correction of the human nervous system.~     Neurological diseases are multisystem, multifactorial, and single target drugs are~     ineffective. Genervon's Master Regulators play a significant role in embryonic/fetal nervous~     system development and are potent disease modification drug candidates modulating many~     pathways including inflammation, apoptotic, hypoxia... The study drug is an regulatory~     peptide with a sequence identical to one of the active sites of human Motoneuronotrophic~     Factor and is manufactured by solid phase synthesis. Pre-clinical research indicates it to~     be a neuro-protective agent in animal models of ALS, motorneuron diseases, PD, other~     neuro-degenerative diseases and stroke. GM604 controls and modulates over many known and~     significant ALS genes with positive effects interactively and dynamically through multiple~     pathways, and up to twenty-two biological processes, including neuro-protection,~     neurogenesis, neural development, neuronal signaling, neural transport, and other processes.~     GM6 is not a cocktail of drugs, but one master regulator peptide drug that functions through~     multiple pathways. Genervon hypothesized that studying the biomarkers of protein expressions~     of these ALS genes such as SOD1 and the protein expression of substances such as tau, NF-H,~     Cystatin C which were indications of degeneration of neuron in the CSF collected from ALS~     patients will provide information of the possible GM604's mechanisms of action in treating~     ALS. 1. This pilot trial is designed to test proof of principle, i.e. determine if a 2-week~     IV bolus treatment with this agent can (1) change ALS protein expression (target biomarkers~     and efficacy biomarkers) after treatment (2) have preliminary effects measures of ALS~     disease clinical progression.~      Study Objectives are:~        1. To test the safety and tolerability of GM604 in a population of ALS patients.~        2. To test for changes in ALS biomarkers before and after treatment.~        3. To determine preliminary effects of injections of GM604 on measures of ALS disease~          biomarkers and clinical progression~   "
91901|NCT01854281|"~     The aim of this study is to determine whether catheter-based closure of patent foramen ovale~     is effective in preventing paradoxical embolization of nitrogen bubbles after simulated~     dives.~   "
91902|NCT01854268|"~     Cough is a defensive behavior that involves three stages. A large inspiratory phase, a~     compression phase where the vocal folds close and subglottal pressure is developed, and an~     expiratory phase. Cough serves to protect the upper and lower airways from material such as~     liquids, solids, or saliva, that have been aspirated. There are two types of cough:~     voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a~     cough that is generated secondary to a stimulus in or near the airway. There has been some~     research regarding the differences between voluntary and reflex cough. However, no research~     has described the differences in airflow or movement pattern (kinematics) between the two~     types of cough. This study seeks to determine the respiratory kinematics and airflow~     differences between voluntary and reflex cough in healthy participants.~   "
91903|NCT01854255|"~     A prospective series of patients with recurrent gastric cancer will be treated with three~     cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in~     the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will~     be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of~     the procedure will be assessed.~   "
91904|NCT01854242|"~     The purpose of this research study is to understand the relationship between inflammatory~     bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been~     established to have an association with IBD with clinical and histologic features that~     mirror those of Crohn disease. Development of the disease seems to be related to the defect~     of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation.~     In the last decade, it has become a standard for patients with GSD type Ib and~     gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not~     recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD~     is greater in patients with GSD type Ia versus the general population.~   "
91905|NCT01854229|"~     The Prometra Pump is approved by the FDA for use in the United States. The purpose of this~     study is to collect long-term safety data on the Prometra Pump.~   "
91906|NCT01854216|"~     To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine~     in Japanese and Caucasian female and male healthy subjects.~   "
91907|NCT01854203|"~     Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of~     treatment-related death and severe acute toxicity. The survival benefit of adding concurrent~     chemotherapy to intensity modulated radiation in patients with locoregionally advanced~     nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with~     radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.~   "
91908|NCT01854190|"~     The purpose of this study is to determine the prevalence of obstructive sleep apnea and~     associate it with the endothelial function behavior in patients with resistant hypertension.~     Two groups will be evaluate, one presenting uncontrolled high blood pressure, and other,~     with controlled blood pressure by drugs.~   "
91920|NCT01854034|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved the drug for your type of cancer or for any use outside of research studies.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC~     patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor~     therapies, with a high response rate, prolonged progression-free survival and possibly~     improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor~     an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed~     therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially~     erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is~     ideal for studying other targeted therapeutic strategies that could affect the oncogene~     mutation in EGFR via alternative mechanisms.~      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This~     drug has been used in other research studies. Information from those other research studies~     suggests that AUY922 may be effective in killing cancer cells in patients with exon 20~     insertion mutations in EGFR.~      The purpose of this study is to test the safety of AUY922 and determine how well AUY922~     works for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.~   "
91909|NCT01854177|"~     In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides)~     modulate the perception of breathing difficulty in patients with chronic obstructive~     pulmonary disease (COPD) (ERJ 2009;33:771; J COPD 2011;8:160). Recently, we found that~     antagonism of substance P (an excitatory neuropeptide) with aprepitant did not affect the~     perception of breathing difficulty. However, after administration of aprepitant, blood~     levels of both substance P(+ 54 ± 39%) and beta-endorphin (+ 27 ± 17%) increased~     significantly. As these blood levels reflect cellular/tissue activity, we postulated that~     the concomitant release of excitatory (substance P) and inhibitory (beta-endorphin)~     neuropeptides had opposing effects (counterbalanced each other) on the perception of~     breathing difficulty.~      The objective of the present study is to further examine the possible role of substance P on~     the perception of breathlessness. We propose to administer oral aprepitant and oral placebo~     in a randomized clinical trial in patients with COPD. However, four hours after patients~     take these medications, intravenous naloxone will be administered in order to block the~     effects of endogenous opioids (beta-endorphin) on opioid receptors. Five minutes later,~     patients will breathe thru a tube with fine wire mesh to provoke breathing difficulty, and~     then provide ratings of the intensity and unpleasantness of breathlessness every minute.~      The two competing hypothesis of the study are:~        1. if breathlessness ratings with aprepitant/naloxone = placebo/naloxone, then substance P~          has no effect on perception of breathing difficulty;~        2. if breathlessness ratings with aprepitant/naloxone ≠ placebo/naloxone, then substance P~          has an effect on perception of breathing difficulty.~   "
91910|NCT01854164|"~     This study was conducted to investigate the effects of daily supplementation of hydrolyzed~     ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).~   "
91911|NCT01854151|"~     Variable and poor-quality drug labeling has been cited as a leading cause of medication~     errors and adverse drug events, especially in the context of low health literacy. This is a~     particularly important issue in pediatrics as more than half of US children are exposed to~     one or more outpatient medications in a given week, and studies suggest that over half of~     caregivers make errors when dosing liquid medications for children. Our study objective is~     to identify evidence-based strategies for labeling and dosing prescription and~     over-the-counter pediatric liquid medications in order to promote safe, appropriate use, as~     well as to inform state and federal policy standards. We hypothesize that a health~     literacy-informed labeling and dosing strategy will result in improved parent ability to~     administer medications prescribed to their young children.~   "
91912|NCT01854138|"~     Determine the extent to which application of the Prevena vacuum system to clean surgical~     incisions immediately following surgical procedure (total hip or total knee arthroplasty)~     will reduce the rates of:~        -  readmission to hospital for surgical intervention due to wound complications~        -  seroma~        -  hematoma~        -  infection compared to group of patients whose wounds were covered with traditional~          gauze dressings.~   "
91913|NCT01854125|"~     Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in~     liver cirrhosis patients with refractory ascites are very wretched. The objective of this~     study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem~     cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver~     cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis~     was confirmed, and several clinical studies have applied MSCs to eliminate the progression~     of fibrosis. In this research the investigators will study the affect and influence of MSCs~     in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.~   "
91914|NCT01854112|"~     Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is~     an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One~     the most widely used TSET techniques consists of six dual fields initially developed at~     Stanford University 2. Dosimetrically, TSET at energies of about 3-7 MeV at the surface of a~     standing patient may result in significant dose variations due to variable skin distance,~     self shielding, irradiated fields overlapping and patient motion. Deviations occur from the~     prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas~     such as the perineum and eyelid, are revealed in the literature. To improve this condition,~     a selection of patients with advanced skin disease and regional extension could be cured by~     a combination of TSEB and photon beam irradiation.~      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment~     length of up to 160 cm, continuously in a helical pattern without the need for field~     junction. Total marrow irradiation (TMI) via HT with low toxicities for bone marrow~     transplantation of Asia multiple myeloma patients could be feasible . A study of HT for~     total scalp irradiation has also shown that the employment of directional and complete~     blocking on the inner structures can effectively force the tangential delivery of the~     majority of beamlets to the PTV, which can limit the treatment depth.~      Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSI~     technique to increase dose delivery and decrease toxicities could be a workable and~     feasible. Here, we applied TSI via HT (HITS) for a woman with T cell lymphoma failure by~     chemotherapy, topic UV irradiation and local radiotherapy (RT) in MMH to overcome the~     surface dose inhomogeneity by conventional RT. Additionally, we will compare the advantages~     and disadvantages between the plan of HT and conventional RT for TSI.~   "
91915|NCT01854099|"~     Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly~     vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation.~     Patients will then be randomized to one of three arms: 1). standard temozolomide~     (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard~     TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3).~     dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly~     cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ~     cycles and continue after TMZ cycles until progression or death.~   "
91916|NCT01854086|"~     The purpose of the study is to provide information about the rate of response and~     persistence to drug therapies for osteoporosis. Another issue examined in this study refers~     to the preferences and concerns about future treatments in patients during drug holiday.~   "
91917|NCT01854073|"~     To determine the value of using Hyoscine as an antispasmodic drug for the management of~     prolonged labor in nulliparous women at term.~   "
91918|NCT01854060|"~     The prevalence of IBS in the community has been reported in numerous cross-sectional~     surveys. However, less is known about the incidence of IBS ,mainly due to its slow~     development and to patients under-reporting. Furthermore, only one study has analyzed data~     concerning potential risk factors for the diagnosis of IBS. The investigators will examine~     the incidence of IBS in a large cohort of young adults and will look at the association of~     socioeconomic, anthropometric and occupational factors with IBS incidence.~   "
91921|NCT01854021|"~     Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced~     immunosuppression has been implicated in the development of post-operative septic~     complications and neoplasm metastasis. General anesthesia is considered to not only suppress~     surgical stress, but also affect the immune function directly，such as altering the number~     and activity of immune cells. It is reported that some anesthetics increase susceptibility~     to tumor metastasis, apparently by suppressing natural killer cell activity. Different~     anesthetic techniques and anesthetics used in anesthesia have shown different effects on~     immunity. Many of the studies were animal trials or performed in vitro; in addition, most~     are focused on a single drug. To date, there is little published prospective clinical~     research designed specifically to investigate the effects of different general anesthetic~     technique on immune function in patients with oral malignant tumors. The aim of this study~     is going to characterize the immune response of patients undergoing surgery for tongue~     cancer under 3 types of general anesthesia.~   "
91922|NCT01854008|"~     The aim of this study was to assess the effectiveness of the implementation of walking urban~     circuits in increasing the level of physical activity and exercise capacity in severe~     chronic obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary~     rehabilitation program.~   "
91923|NCT01853995|"~     The aim of the current controlled trial was to assess the possible net skeletal and dental~     effects of FLMGM treatment in relation to growth with emphasis on the contribution of~     skeletal and dental changes to sagittal correction of Cl II/1 malocclusion.~      The null hypothesis stated that there were no significant differences in dentoskeletal~     changes between FLMGM treated group and control untreated group.~   "
91924|NCT01853982|"~     This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the~     safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV~     piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult~     participants .~   "
91925|NCT01853969|"~     This study will investigate how soon a patient's typing proficiency returns to their~     pre-operative levels following carpal tunnel release surgery. In order to determine this,~     patients will undergo typing tests at different time points that will record their typing~     accuracy and speed. The results will then be compared to determine on average how soon a~     person returns to their pre-operative baseline results.~   "
91926|NCT01853956|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
91927|NCT01853943|"~     Transradial coronary procedures are gaining in popularity worldwide. A possible complication~     of transradial approach is the occlusion of the radial artery that in most cases is~     asymptomatic. However the investigators do not know if the radial artery occlusion may~     impact over the muscle force of the hand or fingers.~      To evaluate if transradial approach for percutaneous coronary procedures may affect muscle~     force of the hand, thumb and index finger the investigators use a standardized hand-grip~     manometer and a pinch gauge before the transradial procedure, the day after the procedures~     and after few months.~   "
91928|NCT01853930|"~     Age-related macular degeneration (AMD) is the most common visual impairment in persons over~     50 years of age. It has been estimated that 1 in 3 individuals over 75 years of age and 1 in~     30 individuals over 52 years of age are affected by AMD. The deficits in visual function as~     a result of this disease affecting the central retina are debilitating, as individuals lose~     their ability to carry out many of their daily activities that require resolving fine~     spatial details. The investigator's previous studies have shown that training with~     oculomotor control exercises significantly increases reading speeds in patients with AMD. In~     the proposed study, the investigators will examine whether these training exercises are~     effective when practiced at home.~      In Phase 1, the investigators will develop a standardized user-friendly, Web-based platform~     that will allow patients to easily self-administer training exercises. The software platform~     will be designed to automatically choose the appropriate exercises based on a patient's~     previous performance, run the training exercise, and collect performance data into a~     universal patient data file. In Phase 2, the platform will be tested in two settings: in~     standard clinical rehabilitation practice and in the patient's home. Reading outcomes in the~     two settings will be compared. The investigators will recruit 60 patients per year for each~     of the three years for Phase 2 of the study. Half of these patients will be assigned to the~     Clinic Training Group, while the other half will be assigned to At-home Training Group. For~     all patients, three assessments will be taken: at baseline, after 1 month, and after 2~     months of training.~      The investigators will compare reading outcomes to assess the roles of feedback versus the~     role of frequent available practice. Because of the extensive cost and clinical resources~     required for vision rehabilitation, it is critical to determine whether the training program~     can be made less expensive, but as effective, when it is self-trained. If the investigators~     demonstrate the utility of at-home practice, clinical facilities and therapists' time can be~     made available for those activities requiring face-to-face contact~   "
91929|NCT01853917|"~     The purpose of this study is to evaluate why the majority of HIV infected women in the~     Harris County Health District system who are pregnant do not come to clinic for their HIV~     disease after they have a baby through questionaires administered prepartum and~     questionaires and structured interviews postpartum. The study will ask subjects questions~     about HIV, drug use, depression and social problems.~   "
91930|NCT01853904|"~     Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to~     collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a~     bronchus, instilling saline, and removing the saline via suction. Two techniques are~     currently used for suctioning: syringe based and channel suction.~      The investigators concern is that channel suction creates too much force and there is~     collapsing of the airways which results in decreased fluid removal as well as cell sampling.~     The investigators propose that syringe based suctioning will not only return more of the~     instilled fluid but also more cells from the alveoli.~   "
91931|NCT01853891|"~     With the advent of electricity, light at night has become a ubiquitous part of our society.~      The main purpose of this study is to determine whether sleeping with dim light (40 lux), the~     brightness of a night light) in your bedroom for 5 consecutive nights will result in~     increased markers of inflammation in the blood compared to sleeping in darkness during the~     night in patients with obstructive sleep apnea (OSA).~      A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and~     RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood~     that dictate what type of proteins the body should make.~   "
91932|NCT01853878|"~     The purpose of this study was to test a potential new kind of anti-cancer treatment, called~     PRAME immunotherapy in resected patients with lung cancer.~      As of 18 July 2014, the recruitment was stopped prematurely and the study was unblinded.~     Only patients on active treatment will have the option to continue in the study. Patients~     randomised to the Placebo group were withdrawn.~      There will no longer be an active follow-up of patients after discontinuation or completion~     of the treatment. The study will end 30 days after the last dose will be administered.~      As a result, primary and secondary objectives will not be assessed as planned. All clinical~     and safety data collected in the study will be analysed descriptively. For each biological~     sample already collected in the scope of this study and not tested yet, testing will not be~     performed by default, except if a scientific rationale remains relevant despite the~     premature termination of the study.~   "
91933|NCT01853865|"~     The present study is conducted, to elucidate the value of follow-up examinations in~     endometrial cancer patients. Specifically the objective is to compare hospital-based~     follow-up examinations with instruction in self-referral in stage I endometrial cancer~     patients.~      The investigators hypothesize that the intervention, instruction in self-referral, will:~        -  reduce fear of recurrence~        -  improve quality of life~        -  improve cost-utility~        -  not affect disease-free survival.~   "
91934|NCT01853852|"~     GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog~     of the terminal galactose group that is cleaved from the substrate GL-3. This compound was~     researched and developed as a drug for treatment of Fabry disease. This study, MGM115806,~     will be the first administration of GR181413A/AT1001 to Japanese subjects to investigate the~     safety, tolerability and pharmacokinetics of single oral doses in healthy Japanese adult~     subjects. Approximately 12 subjects will receive three treatments of 50, 150 and 450 mg~     GR181413A/AT1001 under fasted conditions plus placebo in a dose ascending crossover design.~     Serial pharmacokinetic samples will be collected and safety assessments will be performed~     following each dose. The pharmacokinetics and dose proportionality of GR181413A/AT1001 after~     single oral doses of GR181413A/AT1001 at the dose levels of 50, 150 and 450 mg under fasted~     conditions will be assessed.~   "
91935|NCT01853839|"~     This is an out-patient based prospective, multi-centre, observational post-marketing~     surveillance study amongst internists and cardiologists. In this study, patients with~     essential hypertension and at least one additional risk factor will be included. Patients~     may take any antihypertensive treatment which is approved for cardiovascular protection~     including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four~     visits from baseline to endpoint with an additional visit before and after the month of~     Ramadan.~   "
91936|NCT01853826|"~     To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and~     have never been treated with an EGFR-TKI~   "
91937|NCT01853813|"~     Bevacizumab in combination with chemotherapy represents a standard of care for first-line~     treatment in patients with advanced colorectal cancer. Molecular predictive factors for~     bevacizumab efficacy have not yet been identified therefore selection of patients more~     likely to benefit from such a treatment approach is not possible. Retrospective analyses~     suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic~     drugs. Primary aim of our clinical trial will be to prospectively ascertain whether~     bevacizumab in combination with chemotherapy has an improved clinical activity in patients~     with high LDH serum levels compared to patients with normal LDH serum levels~   "
91938|NCT01853800|"~     Rivaroxaban is a substance developed for use in the treatment of blood coagulation~     disorders. Thrombosis (blood clots) can occur as a result of excessive coagulation activity~     in the blood vessels. Excessive coagulation activity can occur in children as well, and~     rivaroxaban is therefore being developed for the treatment of thromboembolic events in~     children and adolescents. As small children are often unable to swallow tablets, an oral~     suspension (mixture of a liquid containing finely distributed solids) has been developed~     which allows dosing according to body weight. The objective of this trial is to compare the~     bioavailability (proportion of a substance that remains available unchanged in the blood~     circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for~     treatment. In order to evaluate the potential influence of food, the oral suspension~     containing 20 mg rivaroxaban will be taken after consuming food. In addition, the~     pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood),~     safety and tolerability will be assessed.~   "
91939|NCT01853787|"~     -  Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease~          (COPD) is also caused by inflammation of peripheral airways walls.~        -  Neutrophils and other inflammatory mediators like Interleukin-6 (IL6), Interleukin-8~          (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis~          Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric~          Oxyde (NO) are implicated in the inflammation.~        -  NO is produced in response to physical and chemical stress on bronchial epithelium and~          plays a critical role in small airways remodelling~        -  Exhaled NO concentration is usually used to monitor bronchial inflammation~        -  The relationship between stretch and strain of small airways and bronchial inflammation~          is not well understood.~        -  The investigators hypothesis is that cyclic opening and closure of peripheral~          obstructed airways through the consequent stretching and strain acting on them can~          provoke an inflammatory response which can be monitored by exhaled NO.~        -  The pharmacological effects of bronchodilators may play a role on bronchial~          inflammation by reducing the stretching stress on bronchiolar walls thus reducing the~          production of NO in exhalate~        -  Data about these physiopathological aspects is missing in literature.~   "
91974|NCT01853332|"~     The purpose of this study is to determine the effects of individual characteristics, life~     stresses, and relationships over time on psychosocial outcomes (e.g. marriage, parenting,~     work) and physical health~   "
91975|NCT01853319|"~     This is an open-label phase III study of regorafenib in patients with metastatic colorectal~     cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this~     study is to provide additional information about the safety profile of Regorafenib.~   "
91976|NCT01853306|"~     This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral~     bioavailability of veliparib in subjects with solid tumors.~   "
91940|NCT01853774|"~     The purpose of this study is to test the effectiveness of a two-phase intervention using~     community-to-clinic navigators to guide individuals from an especially hard-to-reach,~     multicultural, and underinsured population into primary care clinics and, subsequently, to~     track effects of the intervention on completion of colorectal cancer (CRC) screening in~     clinics. A cost-effectiveness analysis will lay the foundation for further implementation~     and dissemination research.~      Aim 1: Test effectiveness of community group education + tailored navigation versus~     community group education only in increasing clinic attendance among low-income,~     multicultural Arizona residents, aged 50 to 75 yrs.~      Hypothesis 1: Individuals receiving group education classes + tailored navigation will show~     higher rates of clinic attendance than those receiving only group education.~      * As a separate critical step for those who make clinic appointments, the investigators will~     examine the effect on follow through to screening, using initial group assignment as a~     control variable in analysis. Patients making clinic appointments will receive referral for~     screening and tailored navigation as usual care.~      Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among~     low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.~      Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I~     will have higher rates of CRC screening test completion than those receiving classes only,~     (however this outcome will be primarily due to clinic attendance).~      Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC~     screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.~      Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to~     final screenings using the RE-AIM model.~      Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and~     Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?~   "
91941|NCT01853761|"~     The purpose of this study was to analyze microcurrent short and long term effects used with~     aerobic exercise on abdominal fat.~   "
91942|NCT01853748|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not approved this drug for use patients undergoing~     adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may~     stop cancer cells from growing. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to prevent~     the recurrence of breast cancer in this research study.~      The use of T-DM1 in this research study is experimental, which means it is not approved by~     any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However,~     it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to~     die in laboratory studies. In preclinical studies, this drug has prevented or slowed the~     growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in~     this study are considered part of standard-of-care regimens in early breast cancer. A~     standard treatment means that this is a treatment that would be accepted by the majority of~     the medical community as a suitable treatment for your type of breast cancer.~      In this research study, the investigators are looking to see if the study drug T-DM1 will~     have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab~     and paclitaxel. The investigators are also hoping to learn about the long term benefits and~     disease-free survival of participants who take the study drug T-DM1 in comparison to those~     participants to take the combination of trastuzumab and paclitaxel.~   "
91943|NCT01853735|"~     The purpose of this study is to determine if Enteral Feeding (EN) in patients with a~     traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN~     will be compared to those who remain nil-per-os (NPO). Additionally, an internal study~     control will be performed by analyzing concurrent injured patients requiring an open abdomen~     who did not have a bowel injury.~      Specific aims:~      Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen~     improves fascial closure rate compared to patients who remain NPO.~      Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces~     infectious complications compared to patients who remain NPO.~      Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a~     lower mortality rate compared to patients who remain NPO.~   "
91944|NCT01853722|"~     This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping~     of the periocular region.~   "
91945|NCT01853709|"~     Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel~     cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common~     problem that occurs up to 20% of procedures. This fact has a deep clinical and economical~     impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of~     lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and~     hospitalized patients are predictive factors of inadequate colonic preparations. These~     circumstances have promoted multiple clinical trials, however there is no consensus about~     the optimal strategy for colonic cleansing. Education in colonic preparation has obtained~     conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the~     commonest preparations used with a similar efficacy. However, the large volume to ingest (4~     litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high~     levels in sodium and phosphate which contraindicate its use in elderly patients and / or~     with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the~     volume of polyethylene glycol thereby improving the tolerance and right colon preparation.~      The aim of this study is to compare the efficacy of a multidisciplinary approach (education,~     fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a~     conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of~     hospitalized patients.~   "
91946|NCT01853696|"~     Graft rejection has traditionally been one of the leading causes of cornea transplant~     failure. To help prevent rejection, corticosteroid eye drops are used for an extended period~     after transplant surgery. The purpose of this study is to compare the efficacy and side~     effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea~     transplant) surgery.~   "
91947|NCT01853683|"~     Appendicitis is one of the most common surgical problems in children, with 20-35% of~     patients having perforated by the time they present to a doctor. In these cases, the patient~     is often treated non-surgically with antibiotics. Once a patient has improved, it is not~     known whether it is better to perform an interval appendectomy (IA) or to continue a~     watchful waiting approach. The purpose of this trial is to determine if expectant~     nonoperative management (watchful waiting) is not inferior compared to IA management after~     successful conservative treatment of appendiceal mass at admission.~   "
91948|NCT01853670|"~     The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT~     imaging to track the dose delivered in head and neck cancer patients, to assess the benefit~     of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on~     kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote~     access tools (preferably internet-based) so that the MD can approve these plans in real~     time.~   "
91977|NCT01853293|"~     This research is designed to assess if problem drinking by treatment seeking individuals can~     be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.~   "
92056|NCT01852266|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children. This study will evaluate the safety and immune response to an RSV vaccine in~     healthy RSV-naïve children.~   "
95316|NCT01809509|"~     Pilot study on molecular quantitation and sequencing of endometrial cytokines gene~     expression and their effect on the outcome of in-vitro fertilization (IVF) Cycle~   "
91949|NCT01853657|"~     The main objective is to access efficacy of first and second line antiretroviral therapy~     (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in~     Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of~     second line ART in patients who were switched after virological failure compared to patients~     who were switched after clinical or immunological failure.~      Other specific study objectives are:~        1. To establish an HIV Cohort Study at the study site.~        2. To assess the rate of virological failure among patients on first line therapy~        3. To compare the clinical, immunological and virological efficacy of second line~          antiretroviral therapy amongst patients randomised to virological monitoring whilst on~          first line compared with those monitored routinely using clinical and immunological~          monitoring.~        4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic~          infections in patients treated at the Komfo Anokye Teaching Hospital HIV services~        5. To obtain parameters for quality of care, e. g. performance of TB screening procedures~        6. To develop strategies to minimise treatment failures, on the basis of the results of~          the study~        7. To generate a large prospective second-line ART cohort, to serve as basis for further~          research projects~        8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital~        9. Capacity building: epidemiology, medical documentation and data base management.~          Enrollment of one PhD and one Master student~   "
91950|NCT01853644|"~     This phase II trial studies how well tivozanib works in treating patients with recurrent~     ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
91951|NCT01853631|"~     Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute~     lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as~     lymphoma or leukemia). The lymphoma or leukemia has come back or has not gone away after~     treatment.~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Both antibodies and T cells~     have been used to treat patients with cancer. They have shown promise, but have not been~     strong enough to cure most patients.~      T cells can kill tumor cells but normally there are not enough of them to kill all the tumor~     cells. Some researchers have taken T cells from a person's blood, grown more of them in the~     laboratory and then given them back to the person.~      The antibody used in this study is called anti-CD19. It first came from mice that have~     developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a~     substance on the outside of these cells called CD19. CD19 antibodies have been used to treat~     people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that~     instead of floating free in the blood it is now joined to the T cells. When an antibody is~     joined to a T cell in this way it is called a chimeric receptor.~      In the laboratory, the investigators found that T cells work better if they also add~     proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells~     last longer in the body but not long enough for them to be able to kill the lymphoma cells.~     The investigators believe that if they add an extra stimulating protein, called CD137, the~     cells will have a better chance of killing the lymphoma cells.~      The investigators are going to see if this is true by putting the CD19 chimeric receptor~     with CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137~     into the other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or~     without CD137 are investigational products not approved by the FDA.~      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to~     see how long the T cell with each sort of chimeric receptor lasts, to learn what the side~     effects are and to see whether this therapy might help people with lymphoma or leukemia.~   "
91952|NCT01853618|"~     Background:~      - Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy~     cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The~     drug will be given with one of two types of treatment for liver cancer. The first type,~     transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor~     through the main blood vessel that is feeding it. That blood vessel is then closed off to~     help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA),~     uses a heated probe to destroy the tumor tissue. Researchers want to study how safe and~     effective these treatments are with the study drug.~      Objectives:~      - To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced liver cancer that has not responded~     to other treatments.~   "
91953|NCT01853605|"~     Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive~     Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for~     breast augmentation, reconstruction, or revision~   "
91954|NCT01853592|"~     Background:~      - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and~     radio waves to take pictures of the body. To help the images show up more clearly, a~     contrast agent is injected into a vein. Researchers are interested in finding contrast~     agents that can help show problems with the blood vessels around the heart. They want to~     test an agent called Gadofosveset Trisodium to see how it works in MRI scans.~      Objectives:~      - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI~     scans.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples before the scanning sessions.~        -  Participants will have an MRI scan after the screening visit. They will have a dose of~          the contrast scan before the study.~        -  Participants will return for one additional MRI scan within 1 to 2 months of each scan.~          Different doses of the contrast agent will be used for each scan.~        -  An additional blood sample will be collected within 1 week of the second MRI scan.~   "
91955|NCT01853579|"~     Mild thyroid failure is a common condition among older adults and has been associated with~     numerous adverse effects on health, such as cardiovascular disease, cognition disturbances~     and muscular problems. Mild thyroid failure has also been associated with an increased risk~     of developing depression. To date, only few studies have investigated the effect of thyroid~     hormone replacement on depression in patients with mild thyroid failure. This study~     therefore aims to assess whether thyroid hormone replacement in older adults with mild~     thyroid failure is associated with a decrease in the presence of depressive symptoms. This~     study forms a substudy of a large international study on thyroid hormone replacement in~     older adults with mild thyroid failure (the TRUST study).~   "
91978|NCT01853280|"~     This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate~     supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated~     features in adults with ADHD, as well as tolerability of this supplementation. The~     investigators will conduct a 12-week double-blind randomized placebo-controlled trial with~     L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators~     propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria~     for ADHD.~   "
95317|NCT01809496|"~     The purpose of this study is to examine the effect of enhanced patient-centered counseling~     (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid~     outcomes.~   "
91956|NCT01853566|"~     The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a~     progressive reduction of 14% secretion per decade of life beginning in the second decade.~     Other studies suggest a disruption in GH secretion in elderly people. These findings suggest~     a possible association between growth hormone deficiency (GHD) and the ageing process.GH~     replacement is well known to improve body composition, leading to a decrease in total body~     fat and an increase in lean body mass. However, GH replacement has only shown an effect on~     muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have~     evaluated the effect of GH replacement on muscle strength in elderly people engaged in a~     program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle~     strength in healthy, non-sedentary men over 50 years old.~   "
91957|NCT01853553|"~     The proposed research will determine the effectiveness of blocking aldosterone for improving~     the health and function of arteries in patients with autosomal dominant polycystic kidney~     disease (ADPKD). The study also will provide insight into how blocking aldosterone improves~     artery health by determining the physiological mechanisms (biological reasons) involved.~     Overall, the proposed research will provide important new scientific evidence upon which~     physicians can base recommendations to patients with ADPKD to decrease risk of developing~     cardiovascular diseases.~   "
91958|NCT01853540|"~     Background:~        -  Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of~          bacteria in the environment. Although PNTM infection is most common in people with lung~          diseases, it can also affect healthy people. It can be difficult to treat, and affects~          parts of the body other than the lungs. For example, PNTM may affect the cilia, the~          hair-like structures inside the nose and lungs that help move dirt and debris out of~          the body.~        -  Ciliary beat frequency (CBF) is a measurement of how fast cilia move. People with PNTM~          infection have a lower CBF than healthy people. Nitric oxide (NO) is a gas in the body~          that may affect CBF. People with PNTM infection produce lower amounts of NO in their~          noses than healthy people. Researchers want to see if a drug called sildenafil can~          increase NO production and CBF. If sildenafil can improve these measurements, it may be~          a useful treatment for PNTM infection.~      Objectives:~      - To study the effect of sildenafil on CBF and NO levels in people with PNTM infection.~      Eligibility:~        -  Individuals at least 18 years of age who have PNTM infection.~        -  Participants must be enrolled in a related National Institutes of Health study on~          bacterial infections. The study is Natural History, Genetics, Phenotype and Treatment~          of Mycobacterial Infections.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have heart and lung function tests, as well as tests of NO production in the nose. They~          will provide samples of sputum and cells from inside the nose.~        -  Before the first study visit, participants will collect sputum samples for 24 hours.~          They will bring the samples to the study visit.~        -  At the first study visit, participants will have heart and lung function tests, as well~          as tests of NO production in the nose. They will provide blood, urine, sputum, and~          nasal cell samples. They will also receive sildenafil tablets to take at home.~        -  Participants will take sildenafil tablets three times a day.~        -  The second study visit will be 7 days after the first one. The tests from the first~          visit will be repeated. Participants will receive more sildenafil tablets to take on~          the same schedule as before.~        -  The third and final study visit will be 30 days after the first one. The tests from the~          first visit will be repeated. Participants will stop taking sildenafil at this visit.~        -  A follow-up phone call will be made about 2 weeks after the final study visit. This~          call will ask questions about quality of life and any symptoms or side effects of the~          study.~   "
91959|NCT01853527|"~     The aim of the study is to assess presence of myocardial ischemia by contrast stress~     echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD)~     by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of~     myocardial ischemia in such patients.~   "
91960|NCT01853514|"~     Primary objective is to determine the impact of messages related to conventionally grown and~     organically grown produce on purchasing behaviors in low-income individuals.~      Secondary objective is to assess knowledge and attitudes about conventionally and~     organically grown fruit and vegetable in low-income individuals.~   "
91961|NCT01853501|"~     The purpose of this study is to determine whether Adipose Derived Stem Cells are effective~     in the treatment of Premature Ovarian Failure (POF). Stem cell transplantation has been~     reported to rescue ovarian function in a pre-clinical mouse model of chemotherapy-induced~     POF; however, maintaining the survival of transplanted cells in human ovarian tissues to~     enable the POF patients regain ovary function over the long-term and achieving a successful~     pregnancy remain a troublesome issue. In this study the investigators are aiming to~     determine whether the CD29+/CD44+ human Adipose Derived Stem Cells could later enable~     ovaries produce mature oocytes.~   "
91962|NCT01853488|"~     Background:~      After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is~     observed. This leads to a osteoporosis which is connected to a high fracture risk.~      Aims:~      To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and~     assessment of fracture risk in subjects with spinal cord injury.~      Subjects:~      250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord~     injury will be recruited for this study. For a reference group, 500 able-bodied persons will~     be measured analogously.~      Methods:~      Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal~     femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric~     bone parameters of the tibia will be measured by using pQCT. All measurements will be done~     unilaterally. For the assessment of potential risk factors for reduced bone stiffness after~     spinal cord injury a questionnaire will be used.~   "
91963|NCT01853475|"~     Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in~     Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained~     using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet~     been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder~     in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate ~ 70%~     due to a small drug drug interaction).~      This study investigates the exposure of piperaquine and OZ439 when co-administered as~     piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of~     Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The~     reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat~     milk~   "
91964|NCT01853462|"~     The purpose of this study is to determine the comparative effectiveness of proprioceptive~     neuromuscular facilitation and balance exercise programs for the rehabilitation of ankle~     sprain injuries.~   "
91990|NCT01853124|"~     The objective of this study is to determine for previously healthy children who present to a~     Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of~     the digestive tract); if compared with placebo, the administration of a probiotic agent~     (Lacidofil) will result in a significantly lower proportion of children developing moderate~     to severe disease over the subsequent 2 weeks and will not be associated with a~     significantly greater occurrence of side effects.~   "
92368|NCT01848145|"~     This is a Phase II, single-arm study of ofatumumab investigating the safety of an~     accelerated infusion schedule of ofatumumab in patients who have received at least one prior~     therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete~     infusion number 3 (2000 mg) within 15 minutes of the planned time.~   "
91965|NCT01853449|"~     Dyspnea refers to the awareness of breathing discomfort that is typically experienced~     during exercise in health and disease. In various participant populations, dyspnea is a~     predictor of disability and death; and contributes to exercise intolerance and an adverse~     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise~     tolerance are among the principal goals of disease management. Nevertheless, the effective~     management of dyspnea and activity-limitation remains an elusive goal for many healthcare~     providers and current strategies aimed at reversing the underlying chronic disease are only~     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific~     medications to complement existing therapies for the management of exertional symptoms is~     timely and clinically relevant. The purpose of this study is to test the hypothesis that~     single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve~     the perception of dyspnea during strenuous exercise in healthy, young men in the presence of~     an external thoracic restriction. To this end, the investigators plan compare the effects of~     inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments~     of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic~     operating lung volumes, contractile respiratory muscle function, cardio-metabolic function~     and dyspnea (sensory intensity and affective responses) during symptom-limited,~     high-intensity, constant-work-rate cycle exercise testing with and without external thoracic~     restriction in healthy, men aged 20-40 years.~   "
91966|NCT01853436|"~     The objective of this study is to demonstrate that acellular dermal matrix, Strattice™~     Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of~     breast reconstructions with implants by avoiding one more surgical step in the operating~     room.~   "
91967|NCT01853423|"~     The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of~     rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older,~     who have facial angiofibromas that would benefit from treatment.~   "
91968|NCT01853410|"~     The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a~     non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada)~     on coronary blood flow in order to assess its potential role as a therapeutic modality for~     the treatment of symptomatic coronary artery disease (CAD). This will occur in patients~     already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part~     of their usual medical care. Further, the investigators will also assess the overall effect~     on blood flow in the body using non-invasive techniques. The primary objective of the~     PERCCAD study is to assess the effect of the gekoTM device on coronary blood flow in~     patients with symptomatic CAD who are undergoing invasive angiographic assessment and~     management with PCI. This evaluation of the gekoTM device is to be performed at the time of~     the patient's already planned invasive assessment and management so that invasive data can~     be collected without exposing the patient to risks other than those already associated with~     their planned procedure and usual clinical care. The secondary objective of the study is to~     assess the effect of muscle stimulation with the gekoTM device on endothelial function and~     peripheral blood flow measured via non-invasive techniques.~   "
91969|NCT01853397|"~     The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment~     with the Liposonix System (Model 2)using a single pass technique.~   "
91970|NCT01853384|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      This research is being done to compare the efficacy of HP802-247 plus compression therapy~     against Vehicle plus compression therapy in achieving complete wound closure over the~     12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.~      At least 440 subjects will participate. The study is going to be conducted in approximately~     5 countries at approximately 50 sites across the European Union.~   "
91971|NCT01853371|"~     This research proposal is submitted to fulfill the requirement of the PHD degree of~     Community Medicine Saudi Board at the Joint Program of Family and Community Medicine in~     Jeddah, Saudi Arabia.~      Background: Cupping is an ancient treatment remedy that has been used for many centuries in~     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular~     treatment because of its religious background. Despite of that, it still has little~     scientific evidence that proves its efficacy. Many hijama healers claim that they have~     observed dramatic improvement in Blood pressure control of hypertension patients. Not many~     studies support that. This study should help to prove or disprove this hypothesis.~      Objectives:~        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure~          patients.~        -  To assess the incidence of wet cupping side effects in the intervention group.~      Methods: The study design is a randomised controlled trial. There will be an intervention~     group of high blood pressure patients who will perform hijama in addition to their usual~     management, and a control group of high blood pressure patients who will receive their usual~     anti-hypertension management only. There will be 4 weeks follow up period. After that, data~     entry, analysis and interpretation will take place.~      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients~   "
91972|NCT01853358|"~     The goal of our study will be to determine the clinical and biological safety of infusing~     immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation~     with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced~     Intensity Conditioning (RIC), as a potential substitute to usual Donor Lymphocyte Infusion~     (DLI), that contain the whole range of immune effectors. The trial will include several~     progressive steps: dose escalation up to a level compatible with the cost-effectiveness~     potential of the device and clinical situation and recombinant interleukin-2 (r-IL2)~     activation of selected NK cells in vitro prior to re-infusion.~   "
91973|NCT01853345|"~     In this study tumor will be tested for cancer causing gene alterations such as mutations or~     copy number alterations. This is called tumor profiling. A panel of experts will review the~     tumor profiling results and determine whether there is a cancer-causing alteration present~     in the tumor. If there is, the experts will determine if there is a targeted drug available~     that could counteract this alteration. If there is an alteration identified and a targeted~     drug available the panel of experts will make an individualized treatment recommendation.~     The results of the tumor profiling and the individualized treatment recommendation can be~     shared with the primary oncologist.~   "
91979|NCT01853267|"~     TITLE Perianal Abscess Packing (PAP): a randomised controlled trial (Pilot study)~      DESIGN Randomised controlled trial.~      HYPOTHESIS In patients with perianal abscesses incision and drainage without packing the~     subsequent cavity will reduce patient discomfort without increasing healing time or~     recurrence compared with management involving cavity packing.~      OUTCOME MEASURES~        -  Length of hospital stay~        -  Time to cavity healing~        -  Recurrent abscess or fistula formation~        -  Pain score~        -  Analgesia usage POPULATION All patients older than 18 years presenting with a perianal~          abscess.~      ELIGIBILITY Exclusion criteria:~        -  under 18 years~        -  those unable to give informed consent~        -  abscesses associated with Crohn's disease or other underlying causes~        -  abscesses in which initial drainage is considered inadequate (if the skin is not open~          sufficiently to allow drainage of the abscess cavity)~      DURATION Until recruitment of subjects is complete~   "
91980|NCT01853254|"~     This open-label, non-randomized, single arm study will provide treatment or re-treatment~     with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus~     (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior~     Pegasys monotherapy or combination therapy or who were considered eligible for treatment~     with Pegasys in previous donor protocols will be eligible to participate in this study.~     Treatment will be on investigator's decision according to the approved label for up to 48~     weeks, with a 24-week safety follow-up.~   "
91981|NCT01853241|"~     The small bowel is poorly suited to standard endoscopy techniques due to its anatomical~     differences from the colon and the upper gastrointestinal tract. The small bowel has an~     average length of 6.7 m, with a free mesentery that resists standard push to advance~     endoscopy techniques. New developments in overtubes, which are placed over an enteroscope,~     have revolutionized doctors ability to deeply intubate the small bowel. Three types of~     'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE)~     and spiral enteroscopy (SE), have been developed. Although studies have been performed on~     these individual techniques, there are no studies comparing SBE and SE, the two techniques~     used in Johns Hopkins.~      The investigators propose performing a prospective, randomised trial, to assess the~     differences between these two techniques. The question of what differences there are between~     these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields,~     time required for the procedure and the sedation requirements, are important questions to~     answer, and depending on the results, would affect the investigators approach to patients~     with small bowel disease.~   "
91982|NCT01853228|"~     The purpose of this study is to examine the safety and efficacy of decitabine in sequential~     administration with cytarabine in children with relapsed or refractory acute myeloid~     leukemia (AML).~   "
91983|NCT01853215|"~     This study is being done to evaluate intraosseous vascular access through the sternum.~   "
91984|NCT01853202|"~     Patients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting~     are at risk for blood clots which form in the veins. The occurrence of blood clots has major~     implications on personal health including the need for blood thinners and monitoring,~     potential bleeding, and complications related to blood clots on cardiovascular health. The~     goal of this study is to determine whether aerobic exercise training is a therapeutic~     strategy to offset risk of blood clots and improve quality of life among cancer patients~     during chemotherapy.~   "
91985|NCT01853189|"~     Asthma is a highly prevalent chronic disease in children. Complementary and Alternative~     Medicine research on asthma showed a potential effect on pediatric patients.~      Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive~     results.~      The aim of study is to further explore the role of OMT on asthma in a pediatric population.~   "
91986|NCT01853176|"~     Background & study question:~      Strategies for post-operative pain control that make use of various different types of~     medicines are advantageous both for patient comfort and for minimizing the use of opioid~     pain medicines and their associated side effects, which include drowsiness, nausea, and~     vomiting. A key element of these strategies is wound injection with local anesthetic~     (numbing medicine) at the time of surgery. Local numbing procedures are used routinely in~     patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine,~     which can last several hours. Multiple studies have shown that locally injected pain~     medicines achieve better pain control, less opioid use, and faster return to normal~     activities, such that the use of one of these local anesthetic medicines is the current~     standard of care.~      Exparel is an extended-release formulation of bupivacaine that can produce local pain relief~     for up to 72 hours. Studies have shown it to provide better post-operative pain control and~     decreased use of opioid medications when compared to patients who did not receive any local~     numbing agents. Exparel has been used successfully in a variety of surgical settings,~     including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast~     augmentation. Its effectiveness has by and large been established in comparison to no local~     anesthetic. In this study, we seek to investigate the benefit of Exparel compared to~     standard bupivacaine infiltration in patients undergoing abdominoplasty.~      Study design:~      Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion~     in this study. Consenting patients will be randomly assigned to standard bupivacaine or~     Exparel by coin toss after their clinic visit. On the day of surgery, the only difference~     between patients assigned to one arm or the other is the local anesthetic used. The surgery~     itself and plan for general anesthesia will be similar. Both groups will have the same pain~     medicines available after surgery.~      Patients will be given a form on which to record twice-daily pain ratings and opioid~     narcotic needs for 3 days after surgery. For patients admitted after surgery, oral and IV~     narcotic use will be collected from their inpatient medical record.~      The primary outcome of interest is daily and cumulative pain scores through 3 days. A~     secondary endpoint is daily and total opioid use over 3 days. Additional measures include~     the time to first post-operative use of opioid medication and incidence of any adverse side~     effects.~   "
91987|NCT01853163|"~     The purpose of the study is to further investigate the safety of six different commercially~     used Gadolinium-containing contrast agents.~      The study has been developed to evaluate Gadolinium retention in patients with renal~     function ranging from stable to severely impaired renal function who had previously (i.e.~     before start of this study) received any of the six different contrast agents within a~     magnetic resonance contrast imaging procedure and who will now undergo a hip or knee~     replacement surgery to get bone and skin samples for analysis.~   "
91988|NCT01853150|"~     Freezing of gait (FOG) means that patients cannot walk without any known causes, other than~     parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet~     suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive~     procedure using electromagnetic induction to stimulate brain. Transcranial magnetic~     stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim~     of this study is to the therapeutic effect of rTMS for the FOG.~   "
91989|NCT01853137|"~     The current trial was designed to investigate the possible initial net skeletal and dental~     effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1~     malocclusion subjects. The null hypothesis stated that there were no significant differences~     in dentofacial changes between FLMGM group and control group.~   "
91991|NCT01853111|"~     Many patients suffer from devastating injuries to vascularized composite tissues.~     Vascularized composite tissues are blocs of functional tissue that can contain multiple~     tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others.~     Examples of patients with severe vascularized composite tissue defects include limb~     amputees, patients with third-degree burns to the face or extremities, soldiers with~     improvised-explosive-device blast injuries to the face, and others. These patients cannot be~     helped satisfactorily with conventional reconstructive surgery; however, recently~     vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs~     became available to this patients. Unfortunately, at this juncture, patients who receive VCA~     must submit to life-long regime of immunosuppressant drugs with serious side effects such as~     infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive~     immune response from the recipient's body to the transplant, while otherwise maintaining~     sufficient immune function to fight infections and other threats. Transplant recipients with~     immune tolerance do not need to take immunosuppression drugs. The investigators believe that~     they can achieve immune tolerance in recipients of face and limb transplants.~   "
91992|NCT01853098|"~     The primary objective of this study is a proof-of-concept study to test whether a novel~     mindfulness based intervention, Positive Affect Training (PAT), can enhance positive affect~     and compassion, and decrease negative affect and feelings of depression. PAT involves a~     combination of practicing mindfulness meditation and loving-kindness meditation in groups.~     The goal of the research is to test the initial feasibility and efficacy in increasing~     positive affect and decreasing negative affect in individuals recruited from the general~     community who experience negative affect. If the training proves to be successful, we will~     test the intervention, in additional studies, on individuals with dysthymic disorder and~     other clinical disorders. PAT is a cost-effective, non-invasive intervention. Therefore if~     effective, it could be an alternative or supplemental intervention option to existing~     psychotherapy for dysthymic disorder.~   "
91993|NCT01853085|"~     The study will evaluate patients diagnosed with primary open angle glaucoma or ocular~     hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance~     with physician standard clinical practice. All treatment decisions lie with the physician.~   "
91994|NCT01853072|"~     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,~     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among~     diabetic subjects following cataract surgery.~   "
91995|NCT01853059|"~     Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This~     is very successful (75% long term survival). During the course of the radiotherapy, other~     organs in the pelvis may be damaged. This can lead to long-term problems with possible~     changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and~     incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain~     during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered~     help with these side effects. At present, there is very little information on the effect~     treatment has on a patient's quality of life, making it difficult to judge if new treatment~     methods are better.~      This project will measure quality of life from the patient's perspective after treatment for~     anal cancer. It will also gather preliminary data on quality of life after the introduction~     of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called~     IMRT.~   "
91996|NCT01853046|"~     To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with~     severe renal impairment when compared to the Control group (cancer subjects with normal or~     mildly impaired renal function)~   "
91997|NCT01853033|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     ABT-122 in subjects with Rheumatoid Arthritis.~   "
91998|NCT01853020|"~     The purpose of this study is to characterize the dose-related effects of~     delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor~     functions.~   "
91999|NCT01853007|"~     The purpose of this study is to test the impact of a newly developed educational program on~     kidney transplant candidates' communication about living and deceased donor kidney~     transplantation.~   "
92000|NCT01852994|"~     The purpose of this study is to determine if exercise training with or without testosterone~     replacement can improve cardiopathy in heart failure patients~   "
92001|NCT01852981|"~     To verify changes in physical activity levels, metabolic markers, and physical fitness as~     results of two physical activity interventions within the Brazilian public health system~     (primary health care).~   "
92002|NCT01852968|"~     The hippocampus is an area of brain which plays an essential role in learning and memory~     processing and is thought to be particularly vulnerable to effects of hypoglycemia (low~     blood glucose). The goal of this project is to examine hippocampal neurochemistry and~     metabolism and identify how diabetes and recurrent hypoglycemia alter the hippocampus.~   "
92003|NCT01852955|"~     Recent evidence demonstrates that perioperative pain continues to be poorly managed among~     ambulatory surgical patients. More importantly, few interventions that minimize~     postoperative pain have also shown to improve patient overall quality of post-surgical~     recovery. Ketorolac has been used to minimize perioperative pain despite the lack of~     evidence for its use when administered as a single dose preventive strategy.Ketorolac has~     also been associated with a higher incidence of perioperative hematomas and the need for~     surgical re-exploration after breast surgery.~      Systemic acetaminophen has become recently available in The United States. In contrast to~     ketorolac, systemic acetaminophen has not been reported to have adverse side effects on~     patients undergoing breast surgery. Although evidence suggests that a single dose~     perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose~     intravenous acetaminophen improves postoperative quality of recovery after ambulatory~     surgery.~      The main objective of the current investigation is to evaluate the effect of a single dose~     systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery.~     We also seek to determine if systemic acetaminophen would decrease postoperative pain and~     the time to hospital discharge in the same population.~      Significance: The current project evaluates a potential intervention to improve~     perioperative pain and recovery after ambulatory breast surgery. Postoperative pain in the~     ambulatory surgical patients has been shown consistently to be poorly managed.~   "
92004|NCT01852942|"~     This study was designed to test the hypothesis that treatment of HIV infected subjects with~     losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will:~        1. reverse existing lymphoid tissue fibrosis,~        2. restore lymphoid tissue architecture,~        3. increase the number and improve the function of peripheral and lymphatic CD4 T cells,~        4. decrease levels of systemic immune activation (IA),~        5. decrease size of the HIV reservoir, and~        6. be safe and well tolerated.~   "
92005|NCT01852929|"~     The purpose of this study is to determine whether obstructive sleep apnea affects sleep~     dependent memory and learning. Subjects with apnea will be given a test of perceptual skill~     learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on~     sleep. Subjects will be tested on this task before and after sleep. The difference in~     performance after sleep compared to before sleep provides a measure of sleep dependent~     learning. Participants will be tested on one night when they have less apnea because they~     are using continuous positive airway pressure (CPAP) as prescribed by their physician, which~     is well known to reduce apnea; and on another night when they are in their native state and~     have a greater degree of apnea. Memory performance will be compared between the two nights~     to determine how apnea affects sleep dependent memory.~   "
92006|NCT01852916|"~     The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is~     superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and~     mechanical ventilation in preterm infants less than 28 weeks gestation following first~     attempt at extubation and removal from mechanical ventilation~   "
92007|NCT01852903|"~     The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour~     period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate~     and placebo.~   "
92008|NCT01852890|"~     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate~     (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.~   "
92009|NCT01852877|"~     Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at~     the Cook County jail and the Illinois Department of Corrections Northern Intake facilities.~     Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative~     effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c)~     predictors of HIV testing.~      Aim-2: Evaluate two case management strategies - correctional case management and~     transitional case management - designed to improve linkage and adherence to appropriate~     medical care after release from incarceration. Correctional case management is a~     longer-term, more intense approach while transitional case management seeks to meet the~     clients' immediate needs, link them to Ryan White case management, and then support the Ryan~     White case manager in assisting these clients. Correctional case management will be compared~     to the standard of care for jail detainees, and to transitional case management for persons~     leaving prison. Outcomes of interest include, (a) HIV viral load and CD4 cell counts over~     time, (b) adherence to medication, and (c) visits to medical providers.~      Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to~     visit an HIV service organization where they can be linked to medical care and case~     management. Outcomes of interest are essentially the same as Aim-2.~      Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates~     living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4~     cell counts, and associated health conditions.~      Aim-5: Assess the uptake of partner notification and social network HIV counseling and~     testing involving HIV-positive persons released from jail and prison as a means to extend~     the reach of the 'seek, test, treat and retain' (STTR) model into the community.~   "
92010|NCT01852864|"~     The biological effects of castration on prostate cancers will be studies by administration~     of degarelix prior to radical prostatectomy.~      The effects will be studied by analysis of gene expression and immunohistochemistry focusing~     on markers of proliferation and apoptosis of samples taken at the time of radical~     prostatectomy (7 days after administration of degarelix).~      Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from~     patients who have not been medically castrated.~   "
92011|NCT01852851|"~     The investigators plan to conduct a randomized controlled trial to evaluate the~     effectiveness and the cost effectiveness of an on-line eLearning program (entitled~     Employment and Arthritis: Making it Work) designed to help people with inflammatory~     arthritis stay employed. The program also includes assessments with 1) an occupational~     therapist, and 2) a vocational rehabilitation counsellor at the end of the program to help~     participants identify and obtain necessary changes at work. People from three provinces will~     be recruited from collaborators' patient and program recipient lists. The study group will~     receive the program intervention and the control group will receive usual care and printed~     educational material. All participants will be followed for five years. The effectiveness of~     the program at improving at work productivity and reducing work cessation will be evaluated~     compared to a control group receiving printed material on employment and arthritis.~   "
92012|NCT01852838|"~     Lung cancer is the most lethal cancer, killing ~1.3 million people worldwide every year.~     Early diagnosis could increase its survival by 3-4 folds. Therefore the yield of screening~     for lung cancer is not a question anymore and the urgent unmet need is to define the group~     that is under a high risk for lung cancer.~      Our lab is focusing on revealing non-invasive biomarkers as for early detection of lung~     cancer. This study specifically focuses on biomarkers that are found in exhaled breath.~     These biomarkers are known as volatile organic compounds (VOCs).The VOCs' profile can~     discriminate between those who suffer from lung cancer and healthy individuals.~      It is well established that a cancer cell can activate their glycolysis (glucose~     degradation) pathway in order to survive. This links malignant processes with this basic~     biochemical, metabolic cycle. This study will focus on the unique processes incurred by~     glycolysis in the tumor cells and its effect on the surrounding environment. By better~     understanding and revealing the exact mechanism, it will become possible to identify the~     biomarkers released by malignant cells that use glycolysis as a source of energy.~      This study's goal is to identify and analyze those distinguishing VOCs. The hope is that~     these VOCs will provide a new innovative possibility of developing the so desperately~     needed, early-detection lung cancer screening method.~      This research will collect and analyze the exhaled breath of participants. The exhaled~     breath will be obtained before and after a glucose challenge test, in which the participant~     is asked to drink a solution containing water and glucose. This study will involve a total~     of seventy participants, fifty of which currently suffer from active lung cancer, while the~     remaining participants belong to a high-risk group.~   "
92045|NCT01852409|"~     Malignant ascites often has a profound impact on the quality of life of cancer patients.~     Current treatments,including dietary, medical, and procedural are often temporary and~     unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab~     for the palliation of malignant ascites might be a novel choice for refractory malignant~     ascites.~   "
92013|NCT01852825|"~     The purpose of this study is to assess the effect on various biomarkers of treatment with~     MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the~     study healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM)~     extract in order to verify the operational performance of NAC and associated sample~     collection methods. Part 2, the main study, is a placebo controlled, double blind study of~     participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary~     hypotheses are that the changes from baseline in post-allergen challenge HDM-specific~     Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after~     treatment with MK-8237 than after treatment with placebo.~   "
92014|NCT01852812|"~     This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the~     treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The~     primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets~     (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with~     PAR.~   "
92015|NCT01852799|"~     This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma.~      The primary objectives of this study is to assess the effect of bortezomib combination~     therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed~     multiple myeloma, as measured by ELISA methodology as previously described analyzing the~     change in biochemical bone marker compared with the baseline value: bone formation marker-~     bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）.~      The secondary objectives of this study are:~        1. Subgroup analysis for the change from baseline in biochemical bone marker based on~          whether or not Bisphosphonate was used.~        2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal~          propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal~          telopeptide region of type I collagen ( ICTP); osteoclast stimulators~          -osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB~          ligand(sRANKL);~        3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by~          repeated quantitative CT-scan;~        4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions;~        5. To determine progression free survival (PFS), 1 year survival, overall survival and~          safety profile following treatment with PAD and ASCT as first-line therapy.~   "
92016|NCT01852786|"~     The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual,~     metabolic, blood coagulation, hormonal and genetic measures.~      Combined oral contraceptives (COCs) is still the most popular contraception method. It is~     possible to find a number of publications about their non-contraceptive benefits, also about~     their adverse events. Most researches are conducted during clinical trials, which are~     commissioned by pharmaceutical companies, in order to compare COCs of different composition.~     This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and~     genetic measures of low dose combined oral contraceptive users- 20 micrograms of~     Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of~     Gestoden. Because this study is not commercial, it is expected to obtain valuable objective~     data - there are very few comparative studies about the impact of COCs to woman's organism.~   "
92017|NCT01852773|"~     This study aims to increase understanding of the short-term and long-term outcome of blunt~     aortic injury (BAI) and to discern if there is an advantage resulting from the type of~     operative treatment used to manage it, either the classic open surgical repair or a newer~     technique known as thoracic endovascular repair (TEVAR). Specifically, this study will~     answer the following questions regarding patients suffering BAI:~        1. What clinical variables affect short-term mortality and neurologic outcome?~        2. What are the long-term treatment-associated complications of open repair and TEVAR?~        3. In patients with a similar injury and physiologic profile, is there a survival~          advantage resulting from the type of operative treatment?~   "
92018|NCT01852760|"~     In this cross-sectional study patients with active or quiescent ulcerative colitis will be~     studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood~     flow and thickness as reliable indices of disease severity and the degree of correlation~     that exists with validated clinical, endoscopic, and histological indices.~   "
92019|NCT01852747|"~     This study is being done to compare people who had a standard of care spinal fusion using~     part of their local bone graft (a small amount of bone from the region of the spine where~     the fusion is occurring) to correct an adult spinal deformity and people who will have a~     standard of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone~     graft substitute) and a local bone graft (a small amount of bone from the region of the~     spine where the fusion is occurring). This study will compare the outcomes of both groups to~     help the Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect~     that Actifuse ABX® will be as good if not better than just a local bone graft.~   "
92020|NCT01852734|"~     The purpose of this prospective non-randomised study is to examine whether two different~     microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the~     uterine fibroid controlled with contrast-enhanced MR examination.~      Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement~     characteristics before intervention and 3 months after interventions will be analysed as a~     potential predictor of volumetric response after embolization.~      Another purpose is to determine long-term follow-up in all patient treated in a period from~     2001-2011 in OUH analysed retrospectively.~   "
92021|NCT01852721|"~     The purpose of this study is to document differences between men and women (referred here as~     gender differences) in diet adherence and in changes in specific dietary intakes and energy~     density in response to a 12-week nutritional education program promoting the Mediterranean~     diet in both the short term (immediately after the end of the intervention) and longer term~     (3 and 6 months after the end of the intervention). The investigators hypothesize that both~     in the short and the longer term, women will have a better adherence to recommendations~     promoting the Mediterranean diet than men namely because of higher self-determination.~   "
92022|NCT01852708|"~     The purpose of this study is to collect maternal blood samples from pregnant women carrying~     a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including~     microdeletions in order to further develop a non-invasive prenatal screening test based on~     fetal DNA isolated from maternal blood.~   "
92023|NCT01852695|"~     In the highly technological environment of the modern neonatal intensive care unit (NICU),~     the infant is physically, psychologically and emotionally separated from its parents.~     Recognition that this impedes parent- infant interaction and is detrimental to the infant,~     led to the development of programs such as family centered care, kangaroo care and~     skin-to-skin care1-3. However, they are based on the common premise that only NICU~     professionals with special skills can provide care for the infant. Parents are relegated to~     a supportive role, and some have described themselves as voyeurs who are allowed to visit~     and hold their infants4. Many feel anxious and unprepared to care for their infants after~     discharge5.~      In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a humane care~     model in which parents provided nursing care for the infant (except for administration of IV~     fluid and medication), while nurses provided teaching and guidance to parents. This resulted~     in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length~     of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents~     and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have~     developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment~     in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their~     families were enrolled in the study. Preliminary results and feedback from parents and~     healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead~     to improved outcomes including improved weight gain(paper submitted for publication). This~     study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the~     efficacy of the FIC model in Canada.~   "
92024|NCT01852682|"~     The purpose of this study is to investigate efficacy and safety, when administering PA21, in~     peritoneal dialysis patients having hyperphosphatemia.~   "
92025|NCT01852669|"~     This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL)~     with and without simultaneous adjunct controlled inversion therapy in the treatment of lower~     pole caliceal stone.~   "
92026|NCT01852656|"~     Influenza disease causes significant morbidity and mortality in the Unites States each year.~     Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic~     lung disease have significantly increased rates of hospitalization from influenza-related~     illnesses compared to healthy adults. Influenza vaccination is the primary means of~     preventing influenza disease. Annual influenza vaccination is recommended for all~     individuals 6 months of age and older in the United States. Influenza vaccination rates are~     sub-optimal, however. Patient reminder/recall has been shown, in multiple studies across a~     variety of age groups and health conditions, to increase immunization rates. However, the~     effectiveness and cost-effectiveness of different types of reminder/recall has not been~     well-studied, particularly in adults. In the fall of 2012, the Population and Prevention~     Services (PPS) Department at Kaiser Permanente Colorado (KPCO) is using 3 different reminder~     strategies for influenza vaccination among adults with asthma and chronic obstructive~     pulmonary disease (COPD). The objective of this study is to provide a rigorous evaluation of~     which strategy is more effective and more cost-effective, to promote influenza vaccination.~   "
92027|NCT01852643|"~     Most of the studies performed to compare the present techniques of rhinoplasty have been~     based on the clinical examination and change of postoperative complaints that cannot be very~     precise in evaluating the advantages of one technique over another. Therefore, in this study~     the investigators are going to compare the efficacy of spreader graft and lateral crural~     overlay techniques by an objective method, rhinomanometry.~   "
92028|NCT01852630|"~     1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of~          Liver & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous~          Bacterial Peritonitis) by ascitic fluid examination at admission.~        2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute~          neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and~          Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be~          randomized to receive cefepime or imipenem.~        3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for~          randomization will be given empirical therapy with 3rd generation cephalosporin~          (ceftriaxone).~   "
92029|NCT01852617|"~     Argentina and Uruguay are among the countries with the highest proportion of pregnant women~     who smoke. The implementation of an effective smoking cessation intervention would have a~     significant impact on the health of mothers and children. The 5 A's (Ask, Advise, Assess,~     Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15~     minutes delivered by a trained provider, which is considered the standard of care worldwide.~     However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel~     cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics~     in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in~     prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving~     tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the~     intervention will decrease the frequency of women who smoke by the end of their pregnancies.~     Prenatal clinics will be randomly allocated to either an intervention or a control group~     after a baseline data collection period. Midwife facilitators in the ten intervention~     clinics will be identified and trained to deliver the 5 A's to pregnant women and will~     then disseminate and implement the program. The ten clinics in the control group will~     continue with their standard in-service activities. A follow-up data collection will be~     conducted immediately after delivery. The intervention will be tailored by formative~     research to be readily applicable to local prenatal care services at busy maternity~     hospitals, as well as to be acceptable to local pregnant women and health providers. The~     study will be conducted in 48 months.~   "
92030|NCT01852604|"~     Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and~     pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with~     ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus~     (HCV)-infected participants.~      Part C of this study is designed to evaluate the safety, tolerability, efficacy and~     pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when~     administered in combination with or without RBV for 12 weeks in treatment-naïve or~     interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.~   "
92031|NCT01852591|"~     There is no study hypothesis. The purpose of this study is to see if the Pneumococcal~     conjugate vaccine (PCV13), when administered before and early after an autologous peripheral~     stem cell transplant will induce an immune response.~   "
92032|NCT01852578|"~     The investigators propose to study the single agent activity of Cabazitaxel in a Phase II~     trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with~     docetaxel, given the fact of its significant activity and its acceptable toxicity profile.~   "
92033|NCT01852565|"~     Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein~     associated phospholipase A2 (Lp-PLA2) currently under clinical development by~     GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse~     cardiovascular (CV) events in patient populations with chronic coronary heart disease and~     after an acute coronary syndrome.~      This study will determine the effect of repeated administration of diltiazem on the~     pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a~     moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.~   "
92034|NCT01852552|"~     Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing~     transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve~     replacement (AVR).~      The objectives of the study are:~        1. Description of neurocognitive status before and after transcatheter aortic valve~          implantation and aortic valve replacement procedures~        2. Description of Quality of Life (QoL) after these procedures~        3. Defining the relevance of baseline psychological, emotional and cognitive factors on~          the outcomes associated to the different treatment modalities~        4. Assessment of costs associated to each of the above mentioned strategies of treatment,~          including costs of the index hospitalization and costs of follow-up.~   "
92035|NCT01852539|"~     The investigators attempted to determine the optimal dose of dexmedetomidine required for~     the successful insertion of LMA during propofol induction without a neuromuscular blocking~     agent.~   "
92036|NCT01852526|"~     This study is designed as a randomized, parallel-group, therapy-controlled trial in a~     clinical care setting at a university hospital. Patients presenting to our outpatient clinic~     with degenerative disc disease or spondylolisthesis will be assessed against study inclusion~     and exclusion criteria. After informed consent and randomization of patients, surgery will~     be performed. Follow-up examinations will take place immediately after treatment during~     hospital stay, and then after another 6 and 24 weeks, for a total study duration of 6~     months. Data will be assessed after 12, 24 and 36 months for a supplemental investigation. A~     further assessment will be performed every year, owing to the possibility that a statement~     regarding ASD cannot be given after 36 months.~      Experimental research in this trial will be performed with the approval of the ethics~     committee of the medical faculty of the University of Cologne and of the university of~     Halle.~   "
92037|NCT01852513|"~     The investigators hypothesize that treatment with QNASL will reduce nasal mucosal~     inflammation induced by the allergy season and prevent the changes in the microbiome caused~     by the allergy season.~   "
92038|NCT01852500|"~     Results from previous studies suggest the association between Osteopathic Manipulative~     Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.~      The primary objective of the present study is to evaluate the effectiveness of sham OMT in~     reducing LOS in a sample of preterm newborns, in order to investigate whether previous~     clinical results could be related to a hypothetical placebo effect.~   "
92039|NCT01852487|"~     Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil~     are available in treatment of androgenetic alopecia, although the former causes decreased~     libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the~     scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth~     in men with androgenetic alopecia, but there is no evidence to support this.~      The investigators conducted a randomized, double-blind, placebo-controlled efficacy and~     tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic~     alopecia.~   "
92040|NCT01852474|"~     In this study, the investigators aim to assess the clinical and neurophysiological effects~     of a non-invasive brain stimulation technique - transcranial direct current stimulation~     (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy.~     Investigators will use different assessment techniques, such as transcranial magnetic~     stimulation (TMS) and kinematics (sensors) to measure changes through the trial.~   "
92041|NCT01852461|"~     Perfusion index may vary according to type of surfactant during the treatment of respiratory~     distress syndrome.~   "
92042|NCT01852448|"~     Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes.~      The mechanisms underlying CFRD development are not fully understood, but recent evidence~     suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve~     incretins (gut secreted hormones that augment insulin secretion in response to a nutrient~     load).~      This study will examine the prevalence of Genome wide association study (GWAS)-implicated~     T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will~     use this information to compare incretin and insulin secretion in non-diabetic children and~     adults with high risk and low risk alleles.~   "
92043|NCT01852435|"~     The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70~     Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma~     Grade 3B patients.~   "
92044|NCT01852422|"~     Pelvic organ prolapse is a common disorder that results in significant patient morbidity.~     Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP)~     and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of~     POP remains largely unknown. Prolapse is thought to be caused by direct injury to the~     levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage~     incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical~     structures employed to repair vaginal prolapse. Despite the frequent use of these structures~     in prolapse surgery, there is a paucity of information regarding the identification of these~     structures outside of surgical dissection. Furthermore, there is no published data~     describing the relative distances between the apex of the vagina and these ligaments in~     women with prolapse. Recent developments in imaging have enabled the identification of the~     distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the~     puboperinealis as the subdivisions of the pubovisceralis. The visualization of these~     structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that~     has been validated in cadavers and in live humans, with excellent interrater reliability.~     The investigators propose to use this technology to explore the anatomy of the sacrospinous~     ligaments.~   "
92046|NCT01852396|"~     The goal of this study is to demonstrate that the novel retroclavicular approach is a safe,~     fast and effective technique for ultrasound-guided brachial plexus anesthesia.~   "
92047|NCT01852383|"~     Dysthymic disorder (DD) denotes chronic depression with fewer symptoms than major depressive~     disorder (MDD), and it affects ~ 2-4 % of adults with a similar prevalence in the elderly.~     In the elderly, dysthymic disorder (DD) has been shown to be associated with suffering and~     disability. The differences between young adult and elderly DD patients indicate that~     findings obtained in young adults with DD cannot be extrapolated to elderly DD patients who~     need to be studied separately. Data from epidemiologic studies support this view. In~     contrast to the data in young adult DD patients, there is a paucity of controlled data on~     the treatment of elderly DD patients. In our center, a double-masked, placebo-controlled~     study of 91 elderly DD patients did not find significant superiority for fluoxetine over~     placebo with response rates of 27.3% for fluoxetine and 19.6% for placebo in intent-to-treat~     analyses, and response rates of 37.5% for fluoxetine and 23.1% for placebo in completer~     analyses. Given the relative failure of selective serotonin reuptake inhibitor (SSRIs) to~     treat geriatric DD effectively, the investigators decided to evaluate the dual reuptake~     inhibitor, venlafaxine.~      The investigators earlier completed an investigator-initiated, open-label 12-week~     venlafaxine (Effexor XR) trial. Of 23 elderly DD patients, 18 completed the trial. Fourteen~     (60.9%) were responders in intent-to-treat analyses with the last observation carried~     forward, and 77.8% were responders in completer analyses. Nearly half the sample (47.8%) met~     criteria for remission. In the intent-to-treat sample, increased severity of depression at~     baseline was associated with superior response and the presence of cardiovascular disease~     was associated with poorer response. These results with venlafaxine indicate that further~     treatment studies of dual serotonin-norepinephrine reuptake inhibitors like duloxetine are~     warranted in elderly patients with dysthymic disorder.~   "
92048|NCT01852370|"~     The purpose of this study is to determine whether bilateral orthotopic lung transplantation~     (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation~     (HSCT) is safe and effective for patients aged 5-40 years with primary immunodeficiency~     (PID) and end-stage lung disease.~   "
92049|NCT01852357|"~     The primary objective of this study is to evaluate the effectiveness of neurofeedback~     training (NFB) on objective measurements of attention in young adults with ADHD. The~     secondary objectives are to evaluate neurofeedback effects on self-report measures of~     attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and~     neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to~     test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with~     attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline,~     after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks~     after the last neurofeedback session. The primary outcome will be change from baseline on~     the Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA)~     a standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham~     training sessions (and average of 4 weeks). Secondary outcomes will be change from baseline~     on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks,~     respectively), at 4 weeks post-training follow-up, and changes from baseline at each time~     point on the Adult Self Report Scale (ASRS) and Mindful Awareness and Attention Scale~     (MAAS). EEG data collected during TOVA attention testing at baseline will be used to model~     EEG differences between ADHD and non-ADHD participants. Additional EEG data collected during~     the TOVA at midpoint (average of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4~     weeks post-NFB will be used to develop statistical models to use as indicators of~     neurofeedback efficacy~   "
92050|NCT01852344|"~     Effortful control refers to the mental processes that help a person to regulate his or her~     own attention, thoughts, and emotions. This study will examine behavioral differences in~     healthy individuals when performing a task that induces fatigue.~      The purpose of this study is to examine the effects of methylphenidate on the cognitive~     functions in healthy individuals when performing fatiguing cognitive tasks.~   "
92051|NCT01852331|"~     The investigators hypothesize that Peony-Glycyrrhiza Decoction (PGD) adjunctive therapy~     could reduce the incidence of prolactin (PRL)-related adverse events in patients with~     schizophrenia and suppress antipsychotic-induced elevation of PRL levels.~      This is a placebo-controlled trial conducted in schizophrenic patients to determine whether~     PGD adjunctive treatment could produce greater biochemical and clinical improvement on~     hyperprolactinemia (hyperPRL) compared to placebo treatment.~   "
92052|NCT01852318|"~     Pruritus s a very distressing problem affecting patients with uremia and the prevalence of~     uremic pruritus (UP) ranges between 22% to 66%. Although some studies suggested pruritus is~     being decreased recently by use of better dialysis techniques, accumulating studies have~     shown the still high prevalence of UP. Because of its long duration, frequency and high~     intensity, UP has been reported to have a negative impact upon the patients' quality of life~     (QoL). However, the therapies in use, including antihistamines, ultraviolets, opioid~     antagonists and topical agents, are generally of insufficient efficacy, failing to provide~     adequate and long-lasting relief. Based on the neuropathic hypothesis and frequent~     co-occurrence of chronic pruritus and peripheral neuropathy in the patients undergoing~     hemodialysis, gabapentin, a medication widely used for a spectrum of neuropathic pain~     syndromes, has recently been suggested to be effective in the treatment of UP.Pregabalin,~     another gabaergic drug structurally related to gabapentin, have an advantage over gabapentin~     in terms of its more rapid response to stressful symptoms. Only two very recently~     small-scaled studies evaluate the effect of pregabalin for UP. However, both these studies~     were not randomized, placebo-controlled trails.As UP is still one of the most vexing and~     disabling symptoms in patients with ESRD, we decided to do this multicenter, randomized~     double-blind placebo-controlled trial (RCT) with a larger sample size and a longer duration.~   "
92053|NCT01852305|"~     Purpose:~      The purpose of this study is to develop a novel pathway to decrease the cost and waiting~     time to manage bariatric surgical patients with obstructive sleep apnea.~      Hypotheses:~      Compared to the current perioperative pathway, the proposed novel pathway incorporating~     overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective~     for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.~      To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage~     obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be~     screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two~     groups:~      The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups~        -  sleep study group (group 1) or~        -  oximetry group (group 2).~   "
92054|NCT01852292|"~     Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo~     plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with~     a platinum therapy.~   "
92832|NCT01842074|"~     The investigators plan to study the role of bortezomib for desensitizing patients awaiting a~     living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA)~     Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4~     hospital in FRANCE.~   "
92057|NCT01852253|"~     Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental~     implants and also affects the supporting bone. Because the number of implants placed in~     everyday clinical practice is continuously increasing, is it reasonable to anticipate an~     increasing prevalence of peri-implantitis. This underlines the necessity for a predictable~     therapy. However, from the literature there is very little reliable evidence suggesting~     which could be the most effective interventions for treating periimplantitis.~      The primary objective of this controlled clinical study is to evaluate the clinical effect~     of decontamination of the implant surface during the surgical treatment of peri-implantitis~     using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective~     is to assess the microbiological effect of decontamination of the implant surface during the~     surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12%~     chlorhexidine solution.~      The primary study parameter is the change from baseline in modified bleeding index.~     Secondary study parameters are: change in microbial composition of the biofilm covering the~     dental implant surface; microbiological composition of the peri-implant sulcus; change in~     probing pocket depth;change in suppuration on probing; change in radiographic marginal bone~     level on standardized intraoral radiographs; change in modified plaque index; implant~     failure, defined as implant mobility of previously clinically osseointegrated implants and~     removal of non-mobile implants because of progressive marginal bone loss or infection;~     complications and adverse events. It is hypothesized that decontamination of the implant~     surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than~     decontamination with a 0.12% chlorhexidine solution.~   "
92058|NCT01852240|"~     Background Increased levels of C reactive protein (CRP) can be found not only within~     individuals with periodontal diseases and those with atherosclerotic alterations but also~     have been proved in men with erectile dysfunction (ED). NO seems to be the key mediator in~     the endothelial-derived vasodilation and penile erection.~      The incidence of ED increases in patients with diabetes, hypertonia, hypercholesteremia,~     cardiovascular diseases and renal failure. First evidence suggests that there is a~     relationship between periodontal disease and ED as well. Due to slow progression of chronic~     periodontal disease (0.3-0.5mm attachment loss/year) it can be assumed, that periodontal~     disease exists mainly before ED develops.~      Specific Aims This cross-sectional study aims to assess the incidence of periodontal disease~     in male individuals with ED. A possible correlation between severity of periodontal disease,~     level of systemic hs-CRP and ED will be assessed. Additionally, further risk factors for~     endothelial dysfunction, such lipid values, will be determined and regarded in the analysis.~      Hypothesis The investigators assume, that severity of ED correlates with severity of~     periodontal disease as well as with systemic involvement assessed by CRP-levels. In detail,~     the investigators hypothesize, that severity of ED (assessed by the questionnaire~     International Index of Erectile Function) correlates with the mean probing depth and the~     level of systemic hs-CRP.~      Material and Methods~        1. st appointment: In the present cross-sectional study 100 male patients with ED will be~          included. Patients who visit the urological department (Rudolfstiftung) for~          ED-treatment will be asked to participate. The erectile dysfunction will be assessed by~          means of a questionnaire (International Index of Erectile Function - IIEF-5). Urologic~          examination. The following blood parameters will be assessed: testosterone, prolactin,~          hs-CRP, tumor necrosis factor (TNF)-alpha, Interleukin-1, total cholesterol, LDL, HDL,~          HbA1c and fasting glucose.~        2. nd appointment: At the department of Oral Surgery (Bernhard Gottlieb School of~          Dentistry) the periodontal situation and the index of decayed-missing-filled permanent~          teeth (DMFT) index of the patients will be determined. A panoramic radiograph for~          assessment of alveolar bone loss and a periodontal status (probing depth, recession,~          bleeding- and plaque-indices) will be performed. The observer at the dental clinic will~          have no information on the severity of the ED (observer blinded).~   "
92059|NCT01852227|"~     In collaboration with the Neurointerventional programs at state university of new york~     Buffalo, state university of new york Stonybrook, Swedish Medical Center, Erlanger Health~     System, Vanderbilt University, and West Virginia University School of Medicine, the~     investigators aim to prospectively collect experiences where direct aspiration as a first~     pass technique is used for thrombectomy procedures.~      The investigators also want to compare specific characteristics from these cases to other~     stroke cases where traditional thrombectomy devices were used.~   "
92060|NCT01852214|"~     Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic~     events. This may be in part attributed to the fact that these patients have reduced response~     to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel,~     used for secondary prevention of ischemic events. Prasugrel and ticagrelor are recently~     approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent~     antiplatelet effects. Head-to-head comparisons between the two drugs are lacking.~   "
92061|NCT01852201|"~     Primary Endpoint:~      The primary objective is to show that AIS patients, ineligible for or refractory to~     treatment with IV-tPA, with appropriate image selection, treated with mechanical~     thrombectomy within 6-12 hours of symptom onset have less stroke related disability and~     improved good functional outcomes as compared to those treated with best MT with respect to~     endpoint defined as:~      • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw~     mRS scores. Statistical details can be found in section 7.2.~      Secondary Endpoints:~        -  90-day global disability in the 6-12 hr cohort assessed via the overall distribution of~          mRS~        -  Proportion of patients with good functional recovery for the 6-12 hr cohort as defined~          by mRS 0-2 at 90 days~        -  Mortality at 30 and 90 days~        -  Intracranial hemorrhage with neurological deterioration (NIHSS worsening >4) within 24~          hours of randomization~        -  Procedure related serious adverse events (SAE's)~        -  Arterial revascularization measured by TICI 2b or 3 following device use~   "
92062|NCT01852188|"~     The purpose of this study is to determine whether the use of sterile or clean gloves during~     labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the~     membranes around the baby.~   "
92063|NCT01852175|"~     Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and~     ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent~     antiplatelet effects compared with clopidogrel and are associated with an improved net~     clinical benefit. However, to date there are limited head-to-head comparisons of these two~     new agents.~   "
92064|NCT01852162|"~     Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of~     treatment for prevention of atherothrombotic events in patients with coronary artery disease~     (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual~     antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in~     particular atrial fibrillation, therefore having an indication to also receive oral~     anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under~     triple therapy which consists of aspirin plus clopidogrel plus an oral anticoagulant. The~     ever raising population with CAD warranting triple therapy and the growing number of~     patients being treated with dabigatran underscores the importance of understanding the~     pharmacodynamic effects of this treatment regimen.~   "
92065|NCT01852149|"~     The purpose of this study is to assess the safety and feasibility of the Mitralign~     Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral~     regurgitation. No formal test of hypothesis is proposed for this trial.~   "
92083|NCT01851902|"~     The purpose of this study is to determine, through continuous monitoring with a cardiac~     monitoring device placed under the skin, the incidence of atrial fibrillation or flutter~     (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It~     is hoped that this information may assist health care professionals in treatment decisions~     related to the early identification of patients at high risk for AF.~   "
92066|NCT01852136|"~     This prospective, multi-center, 2 period cross-over study is designed to determine if people~     who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle~     (PN) in comparison with currently marketed pen needles of the same or similar gauge and~     length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN~     each for one week in a randomly assigned sequence, and will be asked to evaluate and compare~     characteristics of the BD NEXT pen needle versus their usual pen needle when used for all~     their pen injections performed at home. Since injection experience may vary according to the~     type of pen device used, equal numbers of subjects will be recruited who are users of three~     of the most commonly used insulin pen injectors.~   "
92067|NCT01852123|"~     In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made~     where there is evidence of heart muscle damage using a blood test to measure the heart~     muscle protein troponin. A new a more sensitive troponin test may help us to identify~     patients with myocardial infarction more easily.~      The investigators propose to evaluate whether use of a novel high-sensitivity troponin test~     to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased~     sensitivity does not reduce specificity for the diagnosis, then this new test will improve~     patient outcome through better targeting of therapies for coronary heart disease. However,~     if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and~     given inappropriate cardiac medications with potentially detrimental outcomes.~      In ten secondary and tertiary care hospitals across Scotland, the investigators will~     undertake a stepped wedge cluster randomized controlled trial of the implementation of a~     novel high-sensitivity troponin test. The primary end-point will be the one-year rate of~     cardiovascular death or recurrent myocardial infarction. This will establish whether the~     introduction of this high-sensitivity troponin test into routine clinical practice is~     beneficial to patient management and outcomes.~      A subset of patients will be asked to give consent for inclusion into a sub-study that will~     permit storage of blood samples and will require the completion of a survey during the index~     admission and after 6 and 12 months of follow up.~   "
92068|NCT01852110|"~     The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622~     compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for~     the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD).~     The trial consists of two stages: Stage 1 and Stage 2. Participants in Stage 1 will be~     randomized to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants~     will be randomized to receive either placebo, or MK-7622 5, 15 or 45 mg once daily.~     Participants will be enrolled in only one stage. Interim analyses will be performed in both~     Stage 1 and Stage 2 to determine whether the trial should continue. Duration of each stage~     is approximately 26 weeks; all participants receive placebo at some time during the trial.~     The primary study hypotheses are the following: Stage 1 - MK-7622 45 mg once daily is~     superior to placebo in improving cognition in participants with mild to moderate AD as~     assessed by mean change from baseline in the 11-item Alzheimer's Disease Assessment~     Scale-Cognitive Subscale (ADAS-Cog11) at Week 12; Stage 2 - At least one of the top two~     doses of MK-7622 (15 mg once daily, 45 mg once daily) is superior to placebo in improving~     cognition in participants with mild to moderate AD as assessed by mean change from baseline~     in ADAS-Cog11 at Week 12.~   "
92069|NCT01852097|"~     Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing~     inflammatory conditions that usually affect the colon and the small intestine. Between 30 to~     45% of patients with IBD do not take their treatment as prescribed by their health care team~     (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA)~     provides a theoretical framework to develop adherence interventions that are patient-centred~     (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the~     medication but there are barriers beyond their control, such as not understanding the~     instructions (practical barriers). Intentional non-adherence is the result of the beliefs~     affecting the patient's motivation to continue with treatment (perceptual barriers).~      Aims~        1. To develop an internet-based intervention to address perceptual and practical barriers~          to adherence to medicine for IBD.~        2. To determine whether the intervention is effective based on change in both types of~          barriers.~      Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD;~     currently prescribed azathioprine, mesalazine, and/or adalimumab.~      240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will~     take part in the study. An online pilot Randomised Controlled Trial will allocate the~     participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or~     Treatment as Usual group. On first visiting the website, participants will be screened for~     eligibility and asked for consent before answering the questionnaires. The website will~     assign intervention modules to be completed based on an individual's profile.~      Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month~     follow-ups.~      Potential Impact A CBT based online intervention tailored to personal needs and concerns may~     benefit a large number of patients with low costs for the national healthcare services. A~     website can be accessed at a time and place convenient to the patient.~   "
92070|NCT01852071|"~     In this current study, the investigators will determine whether using a lentiviral vector~     (based on HIV-1) will be more effective and safer at gene transfer to hematopoietic stem~     cells compared to previous gene transfer vectors based on murine (mouse) retroviruses for~     ADA-deficient SCID. The level of gene transfer in blood cells and immune function will be~     measured as endpoints.~   "
92071|NCT01852058|"~     This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the~     treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who~     successfully completed Study 191622-120.~   "
92072|NCT01852045|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of~     urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between~     the ages of 5 to 17 years.~   "
92073|NCT01852032|"~     The purpose of this study is to compare the imaging performance of an investigational breast~     computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast~     tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis~     images), built by Hologic, Incorporated, in a group of patients with suspected breast~     cancer.~   "
92074|NCT01852019|"~     To demonstrate that patients treated with cangrelor can be directly switched to oral~     prasugrel and that patients treated with prasugrel can be switched to cangrelor without a~     significant decrease in the extent of inhibition of platelet aggregation.~   "
92107|NCT01851590|"~     The current study is conducted to corroborate the previous observational clinical trial with~     more valid methods and a more clinically relevant experimental design. This study aims to~     compare efficacy, safety, and cost between topically administered 30% resin lacquer for the~     treatment of dermatophyte toenail onychomycosis and the current best practices: topical 5%~     amorolfine and systemic terbinafine.~   "
92075|NCT01852006|"~     Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive~     pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia)~     and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches~     yield meaningful symptom improvements there remains many COPD patients incapacitated by~     dyspnea. Accumulating evidence suggests that abdominal binding (AB) is a potentially novel~     method of improving respiratory muscle function and, by extension, dyspnea and exercise~     tolerance in COPD. Thus, the purpose of this randomized, cross-over study is to test the~     hypothesis that AB improves exertional dyspnea and exercise tolerance in symptomatic~     patients with COPD by improving dynamic respiratory muscle function. To this end, the~     investigators will examine the effects of AB on detailed assessments of baseline pulmonary~     function (spirometry, plethysmography), dyspnea (sensory intensity & affective responses),~     neural respiratory drive (diaphragm EMG), contractile respiratory muscle function~     (esophageal, gastric & transdiaphragmatic pressures), ventilation, breathing pattern and~     cardiometabolic function during symptom-limited constant load cycle exercise (75% Wmax) in~     20 patients with GOLD stage II/III COPD.~   "
92076|NCT01851993|"~     Dyspnea refers to the awareness of breathing discomfort that is typically experienced~     during exercise in health and disease. In various participant populations, dyspnea is a~     predictor of disability and death; and contributes to exercise intolerance and an adverse~     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise~     tolerance are among the principal goals of disease management. Nevertheless, the effective~     management of dyspnea and activity-limitation remains an elusive goal for many healthcare~     providers and current strategies aimed at reversing the underlying chronic disease are only~     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific~     medications to complement existing therapies for the management of exertional symptoms is~     timely and clinically relevant. The purpose of this study is to test the hypothesis that~     single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will~     improve the perception of dyspnea during strenuous exercise in health, young men. To this~     end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled~     ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG),~     ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory~     muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective~     responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing~     in healthy, men aged 20-40 years.~   "
92077|NCT01851980|"~     Breathlessness on exertion is a common and troublesome complaint of individuals with~     restrictive lung disorders. In these adults, breathlessness contributes to physical~     activity-limitation and avoidance and an adverse health-related quality-of-life, often in a~     self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise~     tolerance are among the principal goals in the management of adults with restrictive lung~     disorders. Nevertheless, effective management of breathlessness and physical~     activity-limitation remains an elusive goal for many healthcare providers and current~     therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially~     successful in this regard. Thus, research aimed at identifying breathlessness-specific~     medications to complement existing therapies for the management of physical activity-related~     breathlessness in restrictive lung disorders is timely and both clinically and~     physiologically relevant. The purpose of this randomized crossover study study is to examine~     the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the~     perception of breathlessness during laboratory-based cycle exercise in healthy, young men in~     the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit.~     To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and~     inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory~     intensity and affective responses) and its physiological determinants (ventilation,~     breathing pattern, dynamic operating lung volumes, cardio-metabolic function)~     symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external~     thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy,~     men aged 18-40 years.~   "
92078|NCT01851967|"~     This study aims to evaluate efficacy and acceptability of the Chinese language version of~     MoodGYM as a therapeutic intervention in treating symptoms of depression in community~     dwelling Chinese Americans in the Boston area.~      Hypothesis 1: Participants enrolled in MoodGYM will show a significant decrease in~     depressive symptoms after completion of the 5 modules.~      Hypothesis 2: Participants enrolled in MoodGYM will show significantly improved~     dysfunctional thinking.~      Hypothesis 3: Participants enrolled in MoodGym will rate this program as culturally~     acceptable.~   "
92079|NCT01851954|"~     The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is~     used for premature infants with ureaplasma.~   "
92080|NCT01851941|"~     The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC)~     with regional lymph node metastasis is still in the area of controversy. The aim of this~     study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional~     5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with~     regional lymph node (LN) metastasis.~   "
92081|NCT01851928|"~     The objective of this study is to evaluate the sensitivity and specificity of two nutrition~     screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two~     tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the~     Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted~     gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools~     are in the form of scored questionnaires and are suitable for electronic input.~      The ultimate objective is to select an adult inpatient nutrition screening tool with the~     highest sensitivity for future use in the oncology inpatient setting in order to allow~     prompt commencement of an appropriate nutrition care plan.~   "
92082|NCT01851915|"~     In this study, the differential effectiveness of CBT and IPT for patients with Major~     Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both~     methods are evidence based and recommended by the National Board of Health in Sweden. They~     are manual based and the patients will receive 14 sessions in each therapy. Their~     comparative effectiveness has not been studied in Sweden, and their effectiveness with~     regard to work capacity has not been tested. The hypotheses in the study are that they have~     equal effect for depression remission, but that CBT is superior when return to work is~     measured. Three moderator analyses, testing effects for different subgroups, will be made.~     They propose that patients with attachment avoidance and lower mentalization ability and~     male patients will have better outcome with CBT. The study will be performed at Sundsvall~     Hospital, in cooperation with Linköping University. Sundsvall hospital is the only hospital~     in Sweden where there is a group IPT therapists large enough to make a controlled study~     possible. The study has a randomized design, with 16 therapists, 8 of them delivering CBT~     and 8 IPT. The number of patients is 96. The statistical power is .87, with a hypothesized~     between-groups effect size of d = .40 for return to work, and the significance level of .05~     for the between-groups difference. Outcome will be measured as remission of psychiatric~     diagnosis, decrease in depression severity and frequency of patients who return to work.~     Both intent-to-treat and completers analyses will be made. The project will go over two~     years. The study has an effectiveness character in the sense that treatments, although~     manual based, will be performed in the manner that the therapists usually work, and by~     having broad inclusion criteria. Treatment integrity will be ascertained by therapist~     reports and by filming sessions.~   "
92084|NCT01851889|"~     The purpose of the trial is to identify factors which can be used as guidance when~     optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.~      The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change~     independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed~     ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.~      The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope~     under ramp testing in a cohort of continuous-flow left ventricular assist device heart~     failure patients.~   "
92085|NCT01851876|"~     Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing~     long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.~   "
92086|NCT01851863|"~     The study hypothesis is appropriate clinician-patient communication that provides~     explanations of the reasons for psychoactive drug prescriptions based on the generation of~     FD symptoms and the drugs' effects might improve compliance with psychoactive agent regimens~     among FD patients.~   "
92087|NCT01851850|"~     The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by~     subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for~     additional three years.~   "
92088|NCT01851837|"~     The exercise time is an important factor among the medical guides for weight loss; however,~     there is still little knowledge about exercise duration paths in middle-aged and older~     women. The present study aimed to determine the effects of the interval training on weight~     loss and lipid profile, and to compare its efficiency with the continuous training.~   "
92089|NCT01851824|"~     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of~     multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in~     participants with BRAFV600 mutation-positive metastatic malignancies. Participants will~     receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg~     orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26,~     eligible participants will have the option to continue treatment with vemurafenib as part of~     an extension study (GO28399 [NCT01739764]).~   "
92090|NCT01851811|"~     Despite widespread agreement that continuous positive airway pressure is effective therapy~     for obstructive sleep apnea, it is estimated that 50% of patients recommended for therapy~     are noncompliant 1 year later. Nasal continuous positive airway pressure (CPAP) is the most~     definitive medical therapy for obstructive sleep apnea (OSA). Many patients have difficulty~     tolerating nasal CPAP due to nasal airway problems, mouth leak, and general discomfort from~     the mask and headgear. Interventions to improve compliance in such patients have not been~     studied. The investigators plan to further evaluate the usage of CPAP and identify if the~     timing of last meal before bedtime affects the compliance and tolerance of CPAP.~   "
92091|NCT01851798|"~     Obstructive sleep apnea (OSA) is a relatively common medical condition that includes~     upper-airway obstruction and consequent cessation of breathing during sleep with significant~     associated other medical problems. The time period around surgery has been demonstrated to~     be an independent risk factor for various complications but the mechanism is not well~     understood.~      This protocol proposes to study the fundamental question of what changes occur in the~     postoperative setting to ambulatory patients with and without OSA by administering a~     validated STOP-BANG screening questionnaire and conducting preoperative and postoperative~     Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the~     understanding of postoperative sleep disorder breathing changes associated with surgery and~     anesthesia. With evidence, sound perioperative management recommendations and policy may be~     developed to assist with caring for this large and at risk surgical population.~   "
92092|NCT01851785|"~     A randomized, controlled design will be utilized to examine and compare the effectiveness of~     the proposed educational intervention, which includes an educational decision aid with~     attention control on select key patient-centered and process of care outcomes. The study~     sample will consist of approximately 300 African-American patients with osteoarthritis (OA)~     of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and~     the Philadelphia VA Medical Center and will be randomized to one of the two study arms.~      The immediate goal of this randomized controlled trial is to assess the effect of a~     high-quality, evidence-based, patient-centered educational intervention on African American~     patient preferences, expectations, and the likelihood of receiving a recommendation for knee~     joint replacement surgery when clinically indicated. The long-term goal of this research is~     to implement effective strategies to improve minority patients' access to joint replacement~     and ultimately eliminate racial disparities in the utilization of this effective treatment~     for knee OA.~      Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of~     receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis:~     The DA intervention will lead to higher rate of treatment recommendation within 6 months.~      Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement~     receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will~     undergo knee replacement within 12 months at a higher rate than those in the attention~     control group.~   "
92093|NCT01851772|"~     The purpose of this study is to evaluate the safety, performance and usability of the Xoft~     Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the~     physician's current standard treatment practice and in replacement of high-dose-rate~     after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected~     on treatment delivery, safety, and acute toxicity.~      Our hypothesis is that the treatment is safe as incorporated into the physician's current~     standard of practice.~   "
92094|NCT01851759|"~     Using placebo as control, The purpose of this study is to evaluate the efficacy and safety~     of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral~     infarction patients, and explore the best safe and effective dose as well as dose method.~   "
92095|NCT01851746|"~     The purpose of this study is to evaluate the effectiveness and security of lobaplatin~     combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.~   "
92257|NCT01849770|"~     The purpose of this research is to find out if mexiletine is safe and effective in people~     with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either~     300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo~     (non-active study drug). The safety and efficacy of these doses will be compared to see if~     one dose is better than the other.~   "
92096|NCT01851733|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided laser surgery~     (MLA) and doxorubicin hydrochloride in treating patients with recurrent glioblastoma~     multiforme. The blood brain barrier (BBB) is a separation of circulating blood from the~     tissue of the central nervous system, preventing substances in the blood from entering the~     brain. MLA disrupts the BBB around the tumor which may allow cancer-killing substances to be~     carried directly to the tumor and the surrounding area. Using MLA prior to chemotherapy may~     result in a greater concentration of drug in the tumor to kill the cancer cells while~     limiting side effects.~   "
92097|NCT01851720|"~     Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache~     management is complex, requiring a balance between pain control and preservation of~     neurological assessment. Sufficient pain control can be achieved with narcotics, however,~     these carry numerous undesirable side effects. Most critically, all narcotics can result in~     respiratory depression and sedation. For patients who present without neurological defects~     but debilitating pain, management is particularly challenging. The sedative effect of~     narcotics confounds the management of these patients by interfering with the neurological~     examination. Pain management is also a significant concern for patient's families as they~     observe suffering without full understanding of the importance of preserved mental status.~     In order to control the pain associated with SAH headaches, the use of narcotics is often~     required despite the risks. This standard therapy involves an IV bolus dose delivered by the~     provider regularly as needed for pain control. A common approach to reduce pain in other~     patient populations, including acute pain relief following major spine surgery, is patient~     controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics~     through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that~     this approach to pain relief for SAH headaches will result in lower pain scores, greater~     patient and family satisfaction scores, and increased patient safety with lower narcotic~     doses minimally interfering with neurological assessment.~   "
92098|NCT01851707|"~     The purpose of this study is to investigate the safety and efficacy of multiple dose levels~     of the investigational product (study drug), IPI-145, in combination with methotrexate~     compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid~     Arthritis.~   "
92099|NCT01851694|"~     In recent years, diabetes has emerged as one of the most significant co-diseases that many~     Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when~     either the body does not make enough insulin or the body does not respond correctly to this~     insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps~     carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic~     fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients~     with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is~     little understanding of CFRD and the best options for treatment remain unclear.~      The purpose of this research study is to examine and understand the various mechanisms that~     contribute to CFRD and gain a better understanding of potential means to treat CFRD. In~     particular, we plan to study the effects of incretin hormones that can enhance insulin~     production in CF patients.~   "
92100|NCT01851681|"~     In order to prevent infections and complications, it has been initially established with the~     dental implant placement protocol that pre- and post-operative antibiotics should be~     prescribed to the patient receiving dental implants. There have been many antibiotic~     regimens used in the attempt to minimize the risks of infections and consequently,~     increasing the survival rate of dental implants placement procedures. However, issues about~     bacterial resistance have been raised recently concerning the extensive use of antibiotics.~     The primary objective of this study is to find out whether giving antibiotics before or~     after implant placement would significantly influence crestal bone loss around dental~     implants. One study group will receive one dosage of antibiotics before implant placement~     followed by post-operative intake of antibiotics for 7 days. Another group will receive the~     antibiotics in one single preoperative dose followed by an identical placebo for 7 days.~     Questionnaires for pain and interference with daily activities assessment to be filled for~     the first postoperative week will be distributed to participants. Signs of postoperative~     morbidity will be recorded at 1 and 3 weeks following the surgery, and both clinical and~     radiographic data will be collected at 4 months postoperative to assess the implants status.~     A radiographic follow-up will be done 1 year after the surgery. Peri-implant crevicular~     fluid levels of 3 known immunological markers for bone loss (MMP-8, sRANKL and OPG) will be~     measured at 1-, 3- and 16-weeks follow-ups. The findings from this study might allow~     clinicians to establish the ideal antibiotic regimen with minimal risk exposure to bacterial~     resistance.~   "
92101|NCT01851668|"~     This is an observational pilot study to quantify the amount of vibration, noise,~     physiological and biochemical instability that premature babies are exposed to during~     inter-hospital transport.~   "
92102|NCT01851655|"~     This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled~     patients had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced~     rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or~     high-intensity plyometric exercise. The objective of the study was to determine the effect~     of plyometric exercise intensity on knee function and knee cartilage in patients with ACL~     reconstruction.~   "
92103|NCT01851642|"~     The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic~     Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability~     to work.~   "
92104|NCT01851629|"~     The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to~     identify the functional integrity of long spinal tracts associated with adaptive walking~     recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes~     associated with an adaptive locomotor training approach post-spinal cord injury.~   "
92105|NCT01851616|"~     The objective of this study is to examine gastric emptying and satiety hormones after oral~     glucose stimulation in 2 different concentrations in morbidly obese patients after~     Roux-en-Y-gastric-Bypass.~   "
92106|NCT01851603|"~     This is a brief inpatient study to determine the safety of a new drug in healthy people.~   "
93568|NCT01832428|"~     This study is single, centre trial to study the safety and efficacy of Bone marrow derived~     autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients~     , the primary outcome measure will be the improvement in muscle power of Body and face~   "
92108|NCT01851577|"~     The purpose of this study is to determine the efficacy of Family Foundations that is to be~     delivered concurrently with home visiting. Delivered prenatally and postnatally, Family~     Foundations is a coparenting prevention program for new mothers and fathers that is designed~     to optimize child outcomes by teaching parents how to work together in raising their child.~     Using a randomized clinical trial design, families will be assigned to receive Family~     Foundations + home visiting or home visiting alone. A comprehensive assessment is~     administered at baseline and then at post-intervention, and 9 and 18 months later. It is~     hypothesized that families receiving Family Foundations will improve in their resolving of~     conflict from pre-intervention through follow-up. Additional anticipated outcomes are that~     those receiving the intervention will have more involved fathers, mothers and fathers will~     report less conflict, and children will have better emotional and behavioral outcomes~     relative to those who receive home visiting alone.~   "
92109|NCT01851564|"~     The mortality rates from Acute Variceal Haemorrhage remain significant and first line~     therapy may fail in 15-25% of patients. The self-expandable metal stent has been described~     in case series as having a very high efficacy at control of haemorrhage from oesophageal~     varices when used as rescue therapy. This randomised controlled trial aims to assess for any~     potential superiority of the stent over 'standard' endoscopic techniques as primary or~     rescue therapy for bleeding oesophageal varices.~   "
92110|NCT01851551|"~     This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a~     single arm, open label study evaluating VSLI plus rituximab in adults with aggressive~     relapsed or refractory non-Hodgkin's lymphoma.~   "
92111|NCT01851538|"~     The Bio-SHiFT study aims to investigate whether disease progression in individual patients~     with chronic heart failure (CHF) can be accurately assessed by serial measurements of~     disease-related (novel) biomarkers. Secondary objectives of the study include comparison of~     2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking~     with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic~     measurements to clinical outcome.~      Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged~     18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of~     inclusion and at follow-up visits, which are performed every 3 months until the end of the~     scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up~     visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed~     in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary~     endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular~     assist device implantation, and re-hospitalization for the management of acute or worsened~     heart failure.~   "
92112|NCT01851525|"~     Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However,~     achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging,~     primary limited both by operator experience and also the limits of currently available~     ablation technology. Direct contact force sensing (CFS) is a novel technology that may help~     to ensure adequate lesion delivery. CFS may also help to improve the safety profile of~     catheter ablation. The purpose of this study is to compare two strategies of wide antral PV~     isolation plus linear ablation for persistent AF:~        1. guided by contact force sensing (CFS) OR~        2. blinded to contact force sensing (CFS) - i.e. standard approach~   "
92113|NCT01851512|"~     This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability,~     safety and pharmacokinetic characteristics of human chorionic gonadotropin between two~     recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy~     subjects. The subjects will injected with these two injections at the the 21day-interval of~     time and their conditions including vital signs, blood, clinical examination will be~     carefully observed.~   "
92114|NCT01851499|"~     Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA~     (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed~     by 1 x 12 weeks treatment period.~   "
92115|NCT01851486|"~     The role of alpha2 receptor agonist on pain perception and modulation will be examined. In~     addition whether this is mediated through the opioid system will be examined. Pain~     perception and modulation will be examined before and after administration of Clonidine or~     placebo together with Naloxone or saline.~   "
92116|NCT01851473|"~     Background:~      - Scientists are studying medications that may be useful in treating cocaine addiction. It~     is important in these studies to know whether study participants are always taking their~     medications as directed. This study will look at two chemicals to see if they can be used to~     determine whether participants are taking their medications as directed. Because~     acetazolamide and quinine can be measured in plasma and urine, they are good test subjects~     for this study. They will be given alone, and combined with intravenous cocaine.~      Objectives:~      - To see how they body handles acetazolamide and quinine alone, and when combined with~     cocaine.~      Eligibility:~      - Individuals between 18 and 50 years of age who have smoked or used IV cocaine for at least~     one year and at least three times per month during the three months prior to screening.~     Urine test positive for cocaine within the prior 6 months~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  This study will involve a 12-day inpatient stay at the National Institutes of Health.~        -  On days 1, 5, and 10, participants will receive a dose of cocaine. Blood, urine,~          breath, and saliva samples will be collected up to 18 times a day for up to about 24~          hours.~        -  On days 2, 3, 4, and 5, participants will receive acetazolamide. Regular blood samples~          will be collected on Day 4.~        -  Day 6 is a wash-out day with no drugs or blood tests.~        -  On days 7, 8, 9, and 10, participants will receive quinine. Regular blood samples will~          be collected on Day 9.~        -  On day 11, blood, urine, breath, and saliva samples will be collected in the early~          morning. Participants will be able to leave later in the day.~   "
92132|NCT01851239|"~     Venous thromboembolism(VTE) is the third most common cardiovascular complication among~     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients~     and there had been many efforts to prevent such complication. The American College of Chest~     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE~     prophylaxis.~      This study focuses on how VTE prophylaxis is being performed in both medical and surgical~     ICUs in a single University hospital, and sees the differences in such prophylactic~     patterns.~   "
92117|NCT01851460|"~     Background:~      - Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called~     chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited~     disorder that affects how white blood cells function. Liver abscesses in people with CGD~     often require surgery to remove them and treat the infection. However, some people with CGD~     cannot have full surgery because it would be too risky. Researchers want to try a procedure~     called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done~     without a major operation. This study will see if RFA is a safe and effective treatment for~     liver abscesses in patients with CGD.~      Objectives:~      - To see if RFA is a safe and effective treatment for CGD-related liver abscesses.~      Eligibility:~      - Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot~     be treated with surgery.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be performed on the liver.~        -  Participants will have RFA for the abscesses. RFA is an image-guided technique that~          heats and destroys specific tissue, such as tumor tissue. It will target any abscesses~          on the liver.~        -  After the procedure, participants will stay in the hospital for monitoring before being~          released.~        -  Participants will have regular follow-up visits for up to 1 year after treatment. Blood~          and urine samples will be collected. Additional imaging studies will be performed.~   "
92118|NCT01851447|"~     Background:~      - Some kinds of muscular dystrophy affect the skeletal muscle membrane. In these conditions,~     the muscle membrane is more fragile. This affects how the muscles contract and relax, which~     causes movement problems. Researchers are looking at several muscle enzymes, or chemicals~     that affect how muscle cells function. By studying changes in these enzymes, they may be~     able to better understand how muscular dystrophy affects the cells. Researchers want to~     collect biomarkers (chemicals from blood samples) from people with fragile sarcolemmal~     muscular dystrophy. This information may provide better treatments for this condition.~      Objectives:~      - To study biomarkers that may affect the muscles of people with fragile sarcolemmal~     muscular dystrophy.~      Eligibility:~      - Individuals at least 18 years of age with fragile sarcolemmal muscular dystrophy.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will be asked to come for four visits to the National Institutes of Health~          Clinical Center. The visits will be at least 2 months apart. Each visit will require~          participants to stay for 5 days at the clinical center.~        -  During each visit, participants will provide frequent small blood samples. These~          samples will be collected while at rest and after physical exercise.~        -  Participants will also have a physical therapy assessment. They will perform standard~          motor function tests and imaging tests (MRI, MRS). These tests may take up to 1 hour~          each time.~        -  Treatment will not be provided as part of this study.~   "
92119|NCT01851434|"~     Background:~      - Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience~     optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance~     imaging (MRI) scans is often greater than that seen in tests given during regular doctor's~     visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more~     information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI~     scans to track changes in the optic nerve after an optic neuritis episode. This approach~     will help them study the relationship between optic neuritis and MS.~      Objectives:~      - To collect more information about the relationship between optic neuritis and multiple~     sclerosis.~      Eligibility:~        -  Individuals between 18 and 50 years of age who have new optic neuritis.~        -  Individuals between 18 and 50 years of age who have new symptoms of MS other than optic~          neuritis.~        -  Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They may~          provide blood or urine samples.~        -  Participants with optic neuritis or other MS symptoms will have a baseline study visit.~          They will have a physical exam and full eye exam. To look for signs of MS, they will~          have evoked potential tests to see how the body responds to stimulation. They will also~          have an MRI scan to study any changes in the brain and optic nerves.~        -  After the first visit, participants will have steroid treatment for 5 days for the~          optic neuritis.~        -  Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline~          visit. The tests from the first visit, including the MRI scans, will be repeated at~          these visits.~        -  Healthy volunteers will have a baseline study visit. They will have a physical exam and~          full eye exam. They will have evoked potential tests to see how the body responds to~          stimulation. They will also have an MRI scan to study any changes in the brain and~          optic nerves.~        -  Healthy volunteers will have additional study visits 2 and 11 months after the baseline~          visit. The tests from the first visit, including the MRI scans, will be repeated at~          these visits.~   "
92120|NCT01851421|"~     Background:~      - Melanocortin receptors are proteins in the body that help send messages between body~     systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating~     body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat.~     Some people who have changes in the MC3R genetic code are heavier than those who do not have~     these changes. These changes are found more often in African Americans. Researchers want to~     study the MC3R in African American adults to see how these changes may affect fat~     metabolism. They will look at overweight adults with either the most common genetic code for~     the MC3R or a rare variant.~      Objectives:~      - To study the role of the MC3R in body weight and fat metabolism.~      Eligibility:~        -  Healthy African American volunteers between 18 and 55 years of age.~        -  Volunteers must be overweight (body mass index at least 30 kg/m2) but weigh less than~          450 lbs.~      Design:~        -  The study consists of an outpatient screening visit and a 7-day inpatient visit with~          dietary studies.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. (Participants will need to fast for 10 hours before giving blood~          samples.) A body scan will be given to determine fat, bone, and muscle content.~          Participants will complete a 3-day dietary assessment to record their food and drink~          consumption. They will also have an exercise test to look at heart and lung function.~        -  Participants will have a 7-day inpatient stay. They will have a regular diet for the~          first 3 days of the study. For the final 4 days, they will have a diet with a higher~          fat content.~        -  During the inpatient visit, participants will have the following study procedures:~        -  Body measurements~        -  Daily exercise routine~        -  Imaging studies of the body~        -  Measurement of a whole day s energy expenditure (spending one day in metabolic~          chamber-day 5)~        -  Frequent blood samples~        -  Urine collection for 24 hours (days 3 and 7)~        -  Fat biopsy (collection of a small sample of fat tissue from under the skin on the~          abdomen)~        -  Insulin and metabolism tests while eating the two different diets (day 4 and day 7).~        -  After the final insulin and metabolism test, participants will be discharged from the~          study.~   "
92121|NCT01851408|"~     This phase II portion of the trial is studying the side effects and best dose of~     temsirolimus when given together with sorafenib and to see how well they work in treating~     patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor.~     Giving sorafenib together with temsirolimus may kill more tumor cells.~   "
92129|NCT01851304|"~     A diet high in easily obtained energy-dense foods leads to the problems of overweight and~     obesity common in the developed world. Foods enriched with fiber or bitter compounds may~     increase satiety and decrease energy intake. This intervention will measure the~     effectiveness of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea~     L. extract in both a free or encapsulated form to decrease energy intake and modify the~     physiological markers of satiety in the short term. In particular bread (fiber) and a~     pudding (Gentiana lutea L. extract) will be used as tasty food matrices in the study.~   "
92130|NCT01851278|"~     The purpose of this study is to compare the small and large dose of corticosteroid used in~     intraarticular injection of wrist.~   "
92122|NCT01851395|"~     Background:~      - People with lung cancers unfortunately commonly succumb to their disease. Some agree to~     donate their bodies to cancer research that may help the medical community better understand~     these diseases. Studies of lung cancer tumor tissue obtained soon after death may be used to~     answer questions about the origins, progression, and treatment of lung cancer. Researchers~     want to conduct a study that involves planned collection of lung cancer tumor tissue shortly~     after death. To do so, they will arrange to provide inpatient hospice care for people with~     non-small cell lung cancer.~      <TAB>~      Objectives:~      - To collect lung cancer tissue biopsy samples as soon as possible after death.~      Eligibility:~      - Individuals who have non-small cell lung cancer and are planning to receive end-of-life~     hospice care.~      Design:~        -  Participants will agree to receive inpatient hospice care at the National Institutes of~          Health Clinical Center. Full details on end-of-life instructions will be noted.~        -  An autopsy will be performed at the clinical center within 3 hours of death. Tumor~          tissue will be collected from the primary site of cancer and from any areas of the body~          to which the cancer has spread.~        -  Participants will not receive further cancer treatments as part of this study. This is~          a tissue collection study only.~   "
92123|NCT01851382|"~     Background:~      - Researchers often collect samples from healthy volunteers to further their research. These~     samples can help better understand serious side effects and complications of transplant~     treatments in patients. This study will collect saliva samples from healthy volunteers.~      Objectives:~      - To collect saliva and blood samples from healthy volunteers for research studies.~      Eligibility:~      - Healthy men ages 30-70 years for Phase I of the study.~      Design:~        -  Participants will be screened with a medical history questionnaire. They will also have~          a brief oral exam to check for any mouth infection.~        -  Participants will provide a saliva sample. The collection process will take about 5~          minutes.~        -  No treatment will be given as part of this study.~   "
92124|NCT01851369|"~     Background:~      - TRC102 is a new cancer treatment drug that may help improve the results of chemotherapy.~     It blocks tumor cells' attempts to repair damaged DNA, which may allow chemotherapy to kill~     the cells more easily. Researchers want to see how well it works with temozolomide, a~     chemotherapy drug that is designed to damage tumor cell DNA. These drugs will be given to~     people who have advanced solid tumors or lymphomas that have not responded to earlier~     treatments.~      Objectives:~      - To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors~     and lymphomas.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have~     not responded to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor samples may also be collected. The size and location~          of the tumors will be determined with imaging studies.~        -  Participants will take TRC102 and temozolomide for 28-day cycles of treatment. They~          will take temozolomide and TRC 102 by mouth once a day on days 1-5. Participants will~          keep a diary to record doses and any side effects.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor~          samples will also be collected.~        -  Participants will continue their treatment as long as the cancer does not grow and~          there are no severe side effects.~   "
92125|NCT01851356|"~     Background:~      - Studies have shown that inflammation plays an important role in depression. Brain~     inflammation may contribute to depression, and may make it more difficult to treat some~     kinds of depression with current therapies. Researchers want to use magnetic resonance~     imaging (MRI) and positron emission tomography (PET) scanning to study inflammation in the~     brain. To do so, they will use a contrast agent, which is a chemical that can show~     inflammation during an imaging study.~      Objectives:~      - To see if people with major depressive disorder have increased inflammation in the brain.~      Eligibility:~      - Individuals at least 18 years of age who have major depressive disorder.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples before the scanning sessions.~        -  Participants will have a PET scan after the screening visit. They will have a dose of~          the contrast agent before the study. This scan will look for possible brain~          inflammation.~        -  Participants will also have an MRI scan. This scan will take pictures of the brain for~          comparison studies.~        -  Treatment will not be provided as part of this study.~   "
92126|NCT01851343|"~     Background:~      - Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types,~     including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there~     is no evidence that after infusion into another person that BMSCs change into any other~     cells. Research suggests that BMSCs can travel to different parts of the body and work with~     immune cells to reduce inflammation and help repair damaged tissues. BMSC infusions have~     been used in tests to treat moderate to severe inflammatory bowel disease, like Crohn's~     disease (CD) or ulcerative colitis (UC). These tests have shown some good results, but more~     research is needed to study their safety and effectiveness. Researchers want to see how well~     BMSC infusions work to treat CD and UC. The BMSCs will be collected from volunteer donors.~      Objectives:~      - To look at the safety and effectiveness of BMSC infusions for moderate to severe CD and~     UC.~      Eligibility:~      - Individuals between 18 and 65 years old with moderate or severe inflammatory bowel disease~     (CD or UC) that has not responded to standard treatment.~      Design:~        -  Participants will have two screening visits. The first will be 15 to 30 days before the~          first BMSC infusion. The second will be within 14 days of the first BMSC infusion.~        -  At the first screening visit, participants will have a physical exam and medical~          history. They will provide blood, urine, and stool samples. They will also give~          information about their symptoms and quality of life.~        -  At the second screening visit, participants will have their vital signs (like blood~          pressure and heart rate) measured. They will also provide blood samples, and have a~          colonoscopy with biopsies.~        -  During treatment, participants will have one BMSC infusion per week for 4 weeks. Blood~          and urine samples will be collected at each treatment visit.~        -  One week after the last infusion, participants will have a study visit. The tests from~          the first and second screening visits will be repeated.~        -  There will be six follow-up visits at 1, 2, 3, 6, 12, and 24 months after the last~          study visit. Participants will repeat the tests from the first screening visit.~   "
92127|NCT01851330|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV)~     administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV~     infection.~   "
92128|NCT01851317|"~     This study is designed to investigate the relationship between patients' position and~     endotracheal tube intracuff pressure in the pediatric population.~   "
92131|NCT01851265|"~     This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure~     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after~     eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take~     olaparib capsules daily and study assessments will be recorded for 6 months (minimum).~     Treatment can continue for as long as the patient is benefitting. Throughout the study~     patients will be monitored for any side effects.~   "
92133|NCT01851226|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult~     techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time~     and perform enough cases to grasp this technique. The methods of ERCP training include~     hands-on teaching, training on different kinds of simulators, training on ex-vivo or live~     anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard~     method for ERCP training.~      Selective cannulation is considered the most difficult and challenging part of learning~     ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP~     training. The time used for attempting cannulation by trainees was 5min or 10min in several~     centers. In ERCP center of the investigators hospital, 15min was used for trainees to~     attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major~     complication related to cannulation, was 4.0%, which was comparable with previous studies.~      The investigators hypothesized that a longer time (15min) for trainees to attempt~     cannulation would increase success rate of selective cannulation and help to improve skills~     more quickly. At the meantime, with actively verbal or hands-on assistance from the~     instructor during performance of trainees, the risk of complications would not increased~     with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded,~     randomized, controlled study was designed to evaluate the effects of different periods of~     time for trainees to attempt selective cannulation on success rate of cannulation,~     self-satisfaction of performance and post-ERCP pancreatitis.~   "
92134|NCT01851213|"~     This study is a prospective, multicenter, observational study to characterize utilization~     patterns of the FoundationOne™ test by oncologists under conditions of routine clinical~     practice in the US. The study will also examine impact of test results on subsequent~     clinical decisions regarding choice of therapy. The planned duration of the study is at~     least 2 years with 1 year for patient recruitment and a minimum 1-year follow-up period for~     each patient. Any patient for whom the treating physician has ordered a FoundationOne™ test~     and a report is delivered is eligible for participation on the study. Eligible patients from~     participating sites will be enrolled sequentially during the 1-year enrollment period. Sites~     will be required to maintain an enrollment log of all patients for whom the FoundationOne™~     test has been ordered and document patient disposition and reasons for non-participation.~     All treatment decisions and clinical assessment will be made at the discretion of the~     treating physician per usual care and are not mandated by study design or protocol. Informed~     consent will be obtained from eligible patients prior to study entry.~   "
92135|NCT01851200|"~     The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ~     cell tumors.~   "
92136|NCT01851187|"~     Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant~     women. Prenatal and intrapartum negative emotions not only damage the mental health of~     pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum~     complications and neonatal outcomes . Due to considerations for the effect on the fetus,~     there is concern of the use of drug treatment for depression during pregnancy. Therefore,~     psychological interventions have an important role. According to the WHO global survey in~     Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had~     the highest rate of caesarean section without indication (11.7%). The embarrassing first in~     the world of caesarean section rate was causing widespread concern in China. Recently, the~     Chinese government has launched a project named promoting the rate of natural childbirth~     and protecting the health of mother and child, trying to reduce the cesarean section rate~     especially that without medical indication. Therefore, examining if emotional management is~     effective in reducing negative emotions of pregnant women as well as decreasing the rate of~     cesarean section is an important research question. Our study aims to help the pregnant~     women control their anxiety, depressive feelings and other negative emotions by emotional~     self-management group training and we examine if this can reduce the incidence of~     depression and improve delivery outcomes.~   "
92137|NCT01851174|"~     To determine whether the occurrence of adverse events can be decreased by moving to a~     bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of~     unresectable/metastatic pancreatic cancer.~   "
92138|NCT01851161|"~     This clinical trial studies prone patient positioning in reducing tumor motion and improving~     breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone~     patient positioning during radiation therapy may help kill tumor cells without harming~     normal tissue.~   "
92139|NCT01851148|"~     The aim of the present study is to determine the extend to which OMT is effective on a~     sample of subjects affected by migraine evaluated using the headache impact test (HIT-6)~     questionnaire.~   "
92140|NCT01851135|"~     The main objective of the study is to investigate the determinants of the quality of life in~     children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific~     impact of neuropsychological deficits. In fact, cognitive impairment is currently considered~     as one of the most pervasive features of this genetic disorder but its relationship with the~     worsening of quality of life found in this population has not been directly investigated to~     date.~      Secondary objectives of this study are (i) to compare neuropsychological and quality of life~     measures between patients and healthy controls matched by age, gender and education level,~     (ii) to contrast neuropsychological deficits incidence between patients and controls, and~     (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.~      The main hypothesis of this study is that the neuropsychological impairment classically~     identified in this clinical population will be associated to the quality of life's worsening~     both in children and adults.~   "
92141|NCT01851122|"~     The amino acid l-theanine (the active ingredient in green tea) is considered to have a~     calming effect without causing sleepiness. This study evaluates whether l-theanine affects~     blood pressure, heart rate, alertness, and sense of well-being.~   "
92142|NCT01851109|"~     The primary purpose of this study is to evaluate the effect of systematic identification and~     genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove~     both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in~     Seattle, WA.~   "
92143|NCT01851096|"~     Heat shock protein 90 (Hsp90) is a chemical in the body that is involved in the promotion of~     cancer. SNX-5422 is an experimental drug that blocks Hsp90.~   "
92144|NCT01851083|"~     Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability~     in children ages 1-14 years old. There are no effective therapies to treat secondary brain~     injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a~     follow-up trial from a previously performed Phase I trial that demonstrated the safety and~     potential CNS structural preservation effect of intravenous autologous bone marrow~     mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as~     a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity~     study. The investigators hope to determine the effect of intravenous infusion of autologous~     BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in~     children.~   "
92145|NCT01851070|"~     Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary~     objective of this study is to evaluate the safety, tolerability and feasibility of a single~     intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at~     12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA)~     who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and~     who have had an incomplete response to at least one TNF-alpha inhibitor.~   "
92146|NCT01851057|"~     Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic~     drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is~     associated with continued seizures, mortality, poor quality of life, and high healthcare~     costs. There are no adherence interventions for young children with epilepsy and their~     families; thus, the current proposal examines a family-based behavioral treatment focused on~     improving epilepsy knowledge and problem-solving around barriers to adherence in young~     children with epilepsy and their families with the goal of improving adherence and~     ultimately, seizures and quality of life. It is hypothesized that children with newly~     diagnosed epilepsy and their families who participate in the problem-solving intervention~     will have significant improvements on adherence compared to those in the education only~     intervention.~   "
92147|NCT01851044|"~     The purpose of this study is to compare the effects of platelet rich plasma, whole blood and~     saline vehicle on the natural course of lateral epicondylitis.~   "
92148|NCT01851031|"~     The aim of the study was to compare the new approach and the retromandibular approach, so~     that the therapeutic effect and the advantages of the new approach would be clear.~   "
92149|NCT01851018|"~     The purpose of this study is to compare toxicities between 2 external beam radiation~     fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard~     use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy~     per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and~     safety of such a treatment regimen in prostate cancer. It may also set base for a larger~     randomized trial.~   "
92150|NCT01851005|"~     Emergence of elderly patients from anesthesia may face with cognitive dysfunction or~     agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for~     general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used~     for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a~     help to smooth emergence from anesthesia in elderly.~      The aims of this study were to investigate the recovery characteristics (time to recovery of~     consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and~     Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs~     during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients~     undergoing elective surgery.~   "
92151|NCT01850992|"~     The purpose of this study is to identify the mechanism(s) by which OSA exacerbates the~     age-linked decline in systemic testosterone concentrations by conducting a randomized order~     sham-controlled crossover study that dynamically evaluates the entire hypothalamic-pituitary~     testicular axis across a wide age range.~   "
92152|NCT01850979|"~     Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune,~     chronic, inflammatory and systemic disease which affects most commonly the lacrimal and~     salivary glands.The ocular treatment is focused in increasing lubrification and decreasing~     inflammation with topical autologous serum, topical immunosuppressive agents and~     corticotherapy. Use of topical immunosuppressants has increased in recent years because the~     topical corticotherapy leads to ocular complications. The most used immunosuppressant is~     cyclosporine. Tacrolimus , another immunosuppressant, has been used in treatment of immune~     and inflammatory ocular diseases.This study describes a prospective controlled~     double-blinded randomized study of the clinical outcome of SS dry eyes patients treated with~     0.03% tacrolimus eye drops. As secondary purposes, outcome of dry eye symptoms and any~     ocular symptoms of the eye drops were also questioned to the patients.~   "
92153|NCT01850966|"~     To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52~     weeks in patients with rheumatoid arthritis in clinical practice~   "
92154|NCT01850953|"~     The objective of this study is to determine the mechanisms by which varenicline, an~     effective smoking cessation treatment, protects against relapse. Varenicline will be~     administered in smokers with schizophrenia and control smokers using a randomized,~     double-blind, cross-over design. Smokers will be asked to stop smoking overnight; the next~     day the ability to resist smoking will be assessed in a laboratory smoking lapse paradigm.~     Measures of tobacco craving, reinforcement and withdrawal-related cognitive dysfunction will~     be correlated with time to lapse. The results could have significant clinical implications~     by identifying mechanisms by which smokers with schizophrenia are at more risk for relapse~     than the general population, leading to the development of more effective smoking cessation~     therapies.~   "
92155|NCT01850940|"~     This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting~     dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg~     intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level,~     change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight,~     edema, renal function, mortality and liver-related complications on day 7 and day 30 to~     evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.~   "
93569|NCT01832415|"~     The French cooperative group GINECO proposes to implement an observational study to describe~     a real situation, in daily practice tolerance and methods of administration of bevacizumab~     (Avastin ®)~   "
92156|NCT01850927|"~     Recent data suggests that subclinical myocardial injury occurs in patients undergoing major~     abdominal surgery, and the degree of damage is proportionally linked to morbidity and~     mortality in the short and medium terms. Therefore, new methods of limiting myocardial~     damage are urgently needed.~      Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion~     stimulus gives a protective effect to further ischemic insults. In remote ischemic~     preconditioning (RIPC), this initial stimulus is carried out away from the region of~     interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing~     cardiac damage during bypass grafting, as characterised by troponin release, seems to be~     about 35%.~      The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in~     patients undergoing major abdominal surgery. Post-operative troponin release will be used as~     a surrogate marker of myocardial damage. There is no good data on which to build a reliable~     sample size calculation, therefore we estimated samples sizes using supplementary data from~     the recent VISION study. The investigators intend to build a clinically powered study from~     the results of this study.~      Study design will be by single-centre single-blind randomised control trial. Allocation will~     be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In~     the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5~     minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group,~     the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia~     for the same amount of time.~      Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive~     Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse~     cardiovascular events, serious surgical complications, non-cardiovascular death, quality of~     life, and length of stay.~   "
92157|NCT01850914|"~     Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the~     elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk~     factors and vascular disease in shunted INPH-patients compared to an age- and sex matched~     elderly population, as well as the impact of vascular risk factors and vascular co-morbidity~     on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that~     INPH-patients have a higher level of vascular risk factors and subclinical organ damage than~     a normal elderly population, and that the higher the level of existing vascular risk~     factors, the more severe the symptoms of the hydrocephalic disease.~   "
92158|NCT01850901|"~     The aim of this study is to assess whether renal denervation (RD) added to usual care~     compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP~     monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at~     least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering~     agents or with documented intolerance or contraindication for to 2 or more of the 4 major~     classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and~     diuretics) obstructing use of 3 antihypertensives~      Further aims are to assess the effect of renal denervation on the use of BP lowering agents,~     to explore the effect of renal denervation in strata of estimated glomerular filtration rate~     (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to~     baseline office BP.~      Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.~   "
92159|NCT01850888|"~     This is a best available therapy/compassionate use single institution study designed to~     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive~     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher~     priority. Patients may receive a range of doses depending on stem cell availability and~     tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death~     will be evaluated.~   "
92160|NCT01850875|"~     The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR)~     in non-specific chronic back pain.~   "
92161|NCT01850862|"~     The investigators hypothesized that an eight-week collective group exercise program would~     improve pain, quality of life and functional capacity in patients with knee osteoarthritis~     (KOA) compared with those receiving no exercise intervention.~   "
92162|NCT01850849|"~     The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data~     when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic~     dermatitis and to healthy subjects.~   "
92163|NCT01850836|"~     To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic~     stimulation (rTMS) on post-stroke non fluent aphasia.~   "
92164|NCT01850823|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare~     the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX®~     Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal~     Allergic Rhinitis~   "
92165|NCT01850810|"~     The objective of this trial is to evaluate a nutritional product for people with Diabetes.~   "
92166|NCT01850797|"~     The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German~     multicenter, prospective, observational registry performed at about 50 study centers~     covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per~     year. Study enrollment will be consecutive. The RASUNOA registry study center is the~     University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry~     will focus on treatment decisions and concepts in patients being under treatment with a new~     oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.~   "
92167|NCT01850784|"~     High energy formula more positively affect growth in infants with congenital heart disease~     compared to standard formula~   "
92168|NCT01850771|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar~     radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and~     durability up to 12 months.~      Secondary objectives include incidence of post-operative complications, adverse events,~     re-injections, and surgical intervention; change in pain score and use of pain medications.~   "
92169|NCT01850758|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete,~     non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation~     of efficacy and durability up to 24 months.~      Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of~     post-operative complications, adverse events, re-injections, and surgical intervention;~     change in pain score and use of pain medications.~   "
92181|NCT01849640|"~     This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability~     and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or~     without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria.~     On the last day of DP therapy, volunteers will be randomized to receive either a single 45~     mg dose of primaquine (PQ) or DP treatment only (no primaquine).~   "
92170|NCT01850745|"~     Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to~     achieve sustained virological response (SVR). The aim of our study is to evaluate the~     efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of~     pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We~     assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups:~     control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131),~     and MSP-validation group (recruited 2007-2009, n=169).~   "
92171|NCT01850732|"~     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms~     (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is~     known to be common with atherosclerotic arterial diseases (coronary artery disease,~     peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should~     be more common among these TIA patients, thus making screening of these patients (for AAA)~     more cost-efficient.~      Study will be carried out as a prospective screening study. Data will be collected in North~     Karelia Central Hospital within one year. All male patients with TIA symptoms will be~     recruited for the study and screened for AAA with ultrasound.~   "
92172|NCT01850719|"~     The purpose of this study is to determine the effectiveness of both arthroscopic knee~     surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older~     patients.~      The investigators assume equal improvement of physical function in both groups and reduced~     costs with conservative treatment.~   "
92173|NCT01850706|"~     The purpose of this study is to find a noninvasive test to help physicians diagnose detrusor~     overactivity (DO), to use this urine test to help diagnose bladder problems, determine if~     treatments are working, and determine if patients are good candidates for interventions like~     sacral neuromodulation/Interstim Therapy.~   "
92174|NCT01850693|"~     This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis~     degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with~     coronary CT angiography.~   "
92175|NCT01850680|"~     Primary Objective:~      To assess the safety and tolerability of a single dose of subcutaneously administered~     sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant~     treatment with methotrexate.~      Secondary Objective:~      To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in~     Japanese RA patients.~   "
92176|NCT01850667|"~     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic~     resection or liver transplantation, but less than 20% of HCC patients are suitable for~     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial~     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete~     response and commonly develops recurrence. Recently several small studies reported high~     tumor response and local control rate after stereotactic body radiotherapy (SBRT) alone or~     with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable~     HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the~     overall response rate of 73% and 2-year local control rate of 95%. They reported severe~     gastrointestinal toxicity of 11% because there was no normal tissue constraint for~     gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest~     levels possible. In addition, they found that the presence of gastroduodenal ulcer before~     SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study,~     we will conduct a multicenter phase II trial on maintenance of treatment results and~     reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply~     normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT~     to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of~     gastrointestinal tract according to gastroduodenal ulcer.~   "
92177|NCT01850654|"~     The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce~     morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying~     individuals at high-risk for CRC (genetically predisposed) and providing screening~     recommendations for cancer risk reduction, the OCCPI will understand how to increase length~     of life and quality of life for those diagnosed with CRC in Ohio, as well as to better~     prevent CRC in others in Ohio.~      Participants will have free tumor screening for Lynch syndrome, and may be eligible for free~     genetic testing and free genetic counseling as part of this study.~   "
92178|NCT01849679|"~     The investigators hypothesize that aspiration will be more prevalent at two to four hours~     post-extubation but will resolve in the majority of patients by 24 to 26 hours~     post-extubation.~      The purpose of the research is to investigate whether there is a difference in swallow~     function two to four hours after extubation (removal of breathing tube) compared to 24 hours~     after extubation. This information will help healthcare providers decide if it is necessary~     for people to wait 24 hours after extubation before they start eating and drinking.~   "
92179|NCT01849666|"~     This open-label, multicenter, parallel study will evaluate the effect of multiple doses of~     vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with~     BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive~     either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients~     will have the option to continue treatment with vemurafenib as part of an extension study~     (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a~     single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in~     the extension study after completion of pharmacokinetic assessments).~   "
92180|NCT01849653|"~     To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria~     gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a~     non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a~     new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT~     (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be~     compared to the result obtained with an SOVS collected in the clinic on multiple platforms~     (Direct Tube Sampling (DTS) / Panther / Tigris). The term home-collected is used to refer~     to any specimen that is not collected in a clinic, since there is no certainty that a~     specimen is collected at home or in a restroom in an office setting, etc. To compare the~     SOVS results to an FDA cleared predicate test with the collection of two clinician collected~     vaginal swabs.~   "
92185|NCT01849588|"~     This research study is a Phase IV clinical trial. Phase IV trials are used to further test~     and monitor the safety of a drug approved by the FDA and to see if the drug has any other~     indications that can be used to treat different diseases.~      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of~     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by~     slowing down and/or stopping the development of new cancer cells and new blood vessels. By~     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed~     that sorafenib prevents or slows down the growth of tumors.~      The researchers of this study would like to study the effects of sorafenib on hepatitis C by~     drawing additional research blood samples from people infected with hepatitis C who are~     receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in~     the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.~   "
92186|NCT01849575|"~     This population based randomized controlled trial (RCT) aims at optimizing cardiovascular~     disease (CVD) prevention through accurate identification of individuals at high risk of CVD~     and accurate perception of the risk, and better compliance to preventive treatments and~     reduced premature CV morbidity and mortality Increased carotid artery intima-media thickness~     (CIMT) and carotid plaques, assessed by ultrasonography, are early signs of atherosclerosis~     and associated with myocardial infarction and stroke. Few studies have systematically~     evaluated image-based risk stratification and its effect on clinical outcomes and results~     are conflicting.~      The Västerbotten Intervention Programme (VIP), Northern Sweden, is integrated in primary~     care services with assessment of traditional CV risk factors and individual health promoting~     counseling for all 40-, 50- and 60-year olds (n=6500/yr). Those with diabetes, hypertension,~     family history of premature CVD and/or hypercholesterolemia are referred to treatment.~      VIP participants with at least one conventional CV risk factor (60% of participants) are~     eligible for inclusion in VIPVIZA. During 2013-2015, 3200 participants will be enrolled.~     Portable carotid ultrasound machines will be used for ultrasound examinations, whereby CIMT~     and plaque formation will be visualized and measured.~      Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written~     information to patient and physician, including graphic presentation in color of CIMT and of~     plaque, vascular age, an ultrasound image, general information about atherosclerosis as a~     dynamic process, and recommendation to follow clinical guidelines for risk factor control.~     2/ Control: No information from the baseline ultrasonography.~      We will explore determinants of behavioral change using psychometric questionnaires and~     level of health literacy. Deep interviews at the time point for the ultrasound examinations~     will explore how the screening relates to risk perception, quality of life, coping~     strategies, attitudes to and skills of self-care.~      Both groups will be managed according to clinical guidelines within the usual health care.~     After three years (2015-2017), the ultrasonography is repeated and information given to all~     participants and their physicians.~      CV risk factors, life style and pharmacological treatments will be assessed after one and~     three years. CV morbidity and mortality and all-cause mortality will be followed during five~     years, i.e. until 2020.~   "
92187|NCT01849562|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks~     of treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV~     subjects.~   "
92188|NCT01849549|"~     Two groups of subjects will be constitute: (i) patients with circumscribed brain injury~     (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or~     degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.~      The objective of this project is to evaluate specific neuropsychological deficits and apply~     current brain imaging techniques (anatomical, diffusion, functional) to patients suffering~     from these cognitive deficits due to brain damage, in order to elucidate the brain~     mechanisms underlying these deficits.~   "
92189|NCT01849536|"~     Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and~     progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP~     circadian rhythm is altered and varied widely between patients. To date, the only way to~     evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour~     hospitalization. This method is expensive and does not reflect physiological conditions~     because it requires IOP measurements during sleeping periods that may potentially produce~     artifacts.~      Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour~     continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical~     device might be influenced by corneal properties of the cornea as central corneal thickness,~     keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance,~     potential modifications of corneal parameters after a 24-hour wear of the lens, and its~     influence on data collected during the whole period of analysis. Then we will also analyze~     the influence of corneal parameters on continuous IOP fluctuations measured with the contact~     sensor and finally the correlation between data collected and the rate of progression~     (severity) of glaucoma evaluated with visual field test or optic nerve head damages.~   "
92190|NCT01850641|"~     The purpose of this study is to investigate the safety and efficacy when administering PA21~     with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.~   "
92191|NCT01850628|"~     This study is a biospecimen discovery project that will serve as a pilot for a comprehensive~     'omics approach using fresh core biopsy tissue and blood samples for DNA and protein~     analysis, as well as paired tumor-normal exome DNA and RNA sequencing.~   "
92192|NCT01850615|"~     This trial is conducted in Asia, Europe, South America, and the United States of America~     (USA).~      The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen~     versus basal insulin therapy, both in combination with metformin in adult subjects with type~     2 diabetes.~   "
92193|NCT01850602|"~     The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis~     patients with hyperphosphatemia~   "
92194|NCT01850589|"~     The aim of this study is to prove that the use of Bupropion with counseling works better~     than counseling alone for patients to quit smoking. The belief is that overall, there is a~     small percentage of patients who quit smoking all together.~   "
92195|NCT01850576|"~     Public health programs and policies have utilized the combination prevention model of~     bringing together tailored, proven interventions in order to reduce the global impact of~     HIV. Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral~     intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings,~     Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV~     prevention) to increase HIV testing and counseling rates, implement proven risk reduction~     programs, and improve rates of linkage to care and ART initiation among adolescents in~     Kenya. The collaboration with St. Francis Community Hospital and input from the Kasarani~     community will increase the breadth, reach, and impact of this HIV prevention intervention~     in Kenya.~   "
93593|NCT01832077|"~     To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment~     of Diabetes retinopathy and Diabetes macular edema.~   "
92196|NCT01850563|"~     Patients with brain metastases who are candidates for treatment with stereotactic~     radiosurgery (SRS) are potential study participants. SRS delivers high-energy,~     precisely-focused radiation to each brain metastasis to shrink the tumor, and is the~     standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of~     radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all~     kinds of tissues, including tumors. The purpose of this trial is to study whether it is~     feasible to treat patients with HBO just prior to receiving SRS, given the timing~     constraints of treating sequentially with HBO and then SRS. Patients will undergo HBO~     treatment followed by the placement of a Gill-Thomas-Cosman head frame then transported ,via~     stretcher, to receive SRS. The transfer and placement of the head frame needs to be~     completed within the 15minute time frame. The trial's secondary objectives are to determine~     whether it has any effects on outcomes and quality of life. As part of study participation~     patients will be asked to complete quality of life questionnaires as well as mini mental~     status questionnaires. These will be done prior to treatment and at follow up appointments~     throughout the next 3 years while participating in the study. Patients will be given the~     option to participate in the optional bio marker blood draw study which would require~     patients to have blood drawn at three time points, pre-treatment, the day after treatment~     and at their first follow up visit.~   "
92197|NCT01850550|"~     The specific objective of this research proposal is to determine the short-term efficacy of~     a primary care-based weight control intervention in which successful volunteer peers deliver~     a group-based program.~      The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a~     successful volunteer peer-led weight control program compared to a control condition to~     determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics~     will be recruited and trained to conduct the intervention. Overweight and obese patients~     (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months~     (primary outcome). The program consists of 12 weekly weight loss sessions led by a~     successful volunteer peer leader using an adaptation of the Diabetes Prevention Program to~     help participants lose weight.~   "
92198|NCT01850537|"~     This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is~     to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar~     Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic~     degenerative disc disease (DDD).~   "
92199|NCT01850524|"~     This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and~     efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in~     patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell~     transplant.~   "
92200|NCT01850511|"~     Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many~     studies have been performed quantifying and describing the impact of a number of factors on~     symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and~     inflammatory causes. Despite this scrutiny, no attention has been paid to the nasal~     vibrissae as a potential anatomical contributor to nasal obstruction. The proposed study~     intends to elucidate that contribution, if any exists.~   "
92201|NCT01850498|"~     Evaluate patient motion during seizures.~   "
92202|NCT01850485|"~     The hypothesis is: In patients after an out of hospital cardiac arrest, treated with~     therapeutic hypothermia (33°C) will be found significantly more microcirculatory~     abnormalities, compared to the same group of patients treated with 36°C.~   "
92203|NCT01850472|"~     The purpose of this research study is to investigate how the brain processes emotions, and~     the way these processes affect behavior. Specifically, we hypothesize that individual~     differences in reward responsiveness will correlate with differential activation in~     mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.~   "
92204|NCT01850459|"~     The purpose of this research study is to establish a way to help the development of targeted~     treatments in autism spectrum disorders. This may also help in early diagnosis of autism and~     may possibly predict severity. The study will compare subject's ERK (extracellular~     signal-related kinase) signaling to age- and gender-matched neurotypical controls and~     Intelligence quotient (IQ)-matched developmental disabilities.~   "
92205|NCT01850446|"~     The purpose of this study is:~        -  to assess efficiency of Ergoferon for treatment of influenza;~        -  to assess safety of Ergoferon for treatment of influenza;~        -  to compare efficiency of Ergoferon and Oseltamivir for treatment of influenza.~   "
92206|NCT01850433|"~     The primary aim is to develop, and test the feasibility, of a novel and protocol-based~     cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered~     via the Internet.~   "
92207|NCT01850420|"~     This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate~     the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia~     symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this~     suspected virus and thus alleviate fibromyalgia symptoms.~   "
92208|NCT01850407|"~     Children are typically inadequately prepared for the sexual abuse medical examination.~     Caregivers report lack of examination knowledge as a barrier to preparing their children.~     The purpose of this study was to determine if informational leaflets provided prior to the~     examination are helpful to caregivers in preparing their children.~   "
92209|NCT01850394|"~     The purpose of this study is to determine 1) the effective dosage of intra-articular~     tranexamic acid injection for controlling blood loss and blood transfusion requirement in~     conventional total knee replacement, and 2) whether the blood loss reduction effect depended~     on the dose of tranexamic acid used.~   "
92221|NCT01850238|"~     This first-time-in-man study is mainly designed to assess the safety and tolerability of~     AADvac1 in the treatment of Alzheimer's disease.~      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is~     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a~     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.~      As this study is a Phase I study focused on tolerability and safety, efficacy will be~     assessed in an exploratory manner.~   "
92258|NCT01849757|"~     The purpose of the study is to determine which priming fluid is the safest for use for~     priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing~     cardiac surgery. The fluids to be compared are albumin and voluven. A control group will~     receive only crystalloid.~   "
92210|NCT01850381|"~     GM608 is an endogenous human embryonic stage neural regulatory and signaling peptide that~     controls the development, monitoring and correction of the human nervous system. The study~     drug is an oligopeptide with a sequence identical to one of the active sites of human~     Motoneuronotrophic Factor and is manufactured by solid phase synthesis. Preclinical research~     indicates it to be a neuro-protective agent in animal models of PD, other neuro-degenerative~     diseases and stroke. This trial is designed to test proof of principle, i.e. determine if a~     2-week treatment with this agent can restore the non-functioning nigral dopaminergic neurons~     in PD over a 3 month period, during which the placebo-treated arm is expected to have little~     or no worsening of the total UPDRS (Unified Parkinson's Disease Rating Scale)score compared~     to baseline.~      Study Objectives are:~        1. To compare the safety and tolerability of GM608 with placebo in a population of~          patients with early PD.~        2. To field test the study procedures for feasibility and efficiency~        3. To determine if there is any hint that injections of GM608 might slow the rate of~          clinical worsening of PD.~   "
92211|NCT01850368|"~     Recently, several studies reported promising outcomes of patients after external beam~     radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis.~     However, conventional EBRT is composed of many fractions (20-35 fractions). On the other~     hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a~     high dose of radiation to the target using a few fractions with a high precision within~     body. SABR increases radiation biologic effect for tumor, makes patients more comfortable~     due to reduction of the number of hospital visit, and enables patients to receive another~     treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for~     HCC with major portal vein tumor thrombosis.~   "
92212|NCT01850355|"~     The main objective of this exploratory 8-week pilot study is to evaluate the safety and~     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism~     spectrum disorders. The study results will be used to generate hypothesis for a larger~     randomized controlled clinical trials with explicit hypotheses and sufficient statistical~     power.~   "
92213|NCT01850342|"~     Autologous washed and homogenized fat micrograft harvested from the patient's front~     abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by~     enzyme-treatment of a portion of the harvested fat. Fat tissue micrograft mixed with ADRC~     will be administered one-time endoscopically into submucosal layer of urethra under eye~     control. This is a single arm study with no control. All patients receive cell therapy.~   "
92214|NCT01850329|"~     This study is planning to develop the computed-assisted information program and determine~     whether the computed-assisted information program are superior to routine discussion for~     informing parents in the emergency department (ED) about risks, benefits, and alternatives~     to receiving procedural sedation for their children.~   "
92215|NCT01850316|"~     Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical~     development of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable~     hepatocellular carcinoma (HCC). These treatments should enhance local control,~     progression-free survival and potentially overall survival in HCC patients. The~     investigators will also examine the mechanism of tumour and microenvironmental response to~     high dose radiation, and search for potential biomarkers to optimize and individualize~     therapy. Pre-treatment and follow-up PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose~     (FDG) and CT perfusion will examine in-vivo changes in proliferation, glycolysis, and the~     tumour vasculature, respectively, and blood samples will look for immunologic biomarkers of~     tumour response.~   "
92216|NCT01850303|"~     For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy~     but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and~     paclitaxel) is better than monotherapy in term of overall survival and progression free~     survival. The current recommendations are now to administer a carboplatin based bitherapy (4~     or 6 cycles). After the treatment is stopped until progression and initiation of a second~     line treatment. The risk of this strategy is to be confronted to a rapid disease progression~     during the free interval. Indeed, about 1/3 of the patients whose disease was controlled~     after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a~     continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the~     treatment of 1st line (induction chemotherapy).~      There is two types of maintenance :~        -  continuous maintenance therapy which consists in continuing the treatment initially~          associated with platinum until disease progression.~        -  switch maintenance which consists in introducing a new treatment after the end of~          induction chemotherapy The two types are validated by several trials. The marketing~          authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.~      Gemcitabine has a good tolerance profile which make possible the use in a maintenance~     strategy. Several trials evaluated maintenance with this product and some show benefits in~     term of progression free survival.~      The objective of this trial is to evaluate the switch maintenance in elderly patient with a~     controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.~   "
92217|NCT01850290|"~     This study will examine resting dopamine function as well as dopamine response in the brain~     as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI)~     patients.~   "
92218|NCT01850277|"~     The purpose of this prospective randomized study is to determine whether patients on cardiac~     resynchronization therapy with concomitant long-standing persistent or permanent atrial~     fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm~     control strategy) in comparison to a rate control strategy in terms of higher biventricular~     paced beats percentage.~   "
92219|NCT01850264|"~     Primary objective of this study is to evaluate whether the use of a quadripolar left~     ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower~     non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)~   "
92220|NCT01850251|"~     The purpose of this study is to determine whether a nutritional supplement high in protein~     and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective~     than a standard nutritional supplement high in protein and energy in improving muscle~     strength in elderly patients with hip fracture.~   "
93594|NCT01832064|"~     The development and pilot testing of a self-management program that would be delivered in a~     one time mailing.~   "
92222|NCT01850225|"~     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear~     anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An~     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the~     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not~     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for~     1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility~     study to determine the safety of the ABI.~   "
92223|NCT01850212|"~     A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50~     year old male subjects and post-menopausal female subjects on any tenofovir disoproxil~     fumarate (TDF)-based regimen~   "
92224|NCT01850199|"~     Gestational diabetes, diabetes diagnosed during pregnancy, affects 8.8% of pregnancies in~     Spain that means more than 40,000 women per year. This prevalence is based on the National~     Diabetes Data Group criteria, previous to the 4th workshop on Gestational Diabetes (1998),~     but, if the new diagnosis criteria proposed by the International Associations of Diabetes~     and Pregnancy Study Groups, based on the most important study never made before on this~     topic, prevalence would increase to the double. When a women is diagnosed, the risk of~     complications for her and the child increases and, therefore, she has to start an specific~     diet and frequent visits to the diabetes center in order to check that glucose values do not~     exceed 95 mg/dl before or 140 mg/dl 1-hour after meals. In other case, she should start~     insulin treatment. Our project is aimed to develop intelligent tools based on neuro-diffuse~     techniques and integrated in a telemedicine system that allows control of gestational~     diabetes automatically, guaranteeing glucose control objectives consecution and avoiding~     face-to-face visits to the health care center. Furthermore, educational and motivation tools~     for a healthy behaviour will be included. At the end of the study efficacy and security~     about insulin management will be compare with the recommendations proposed by the diabetes~     team and data about direct and indirect costs will be calculated. The investigators~     anticipate that the smart telemedicine system can allow us to detect high blood glucose~     values earlier than in-person scheduled visits.~   "
92225|NCT01850186|"~     Recent data highlight the role of vascularity in melasma and a recent study showed the~     interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a~     copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser~     can target both the vascular and pigmented components of melasma. A preliminary study has~     shown its efficacy and excellent tolerability in the treatment of melasma. This study~     requires however to be confirmed by a comparative study versus reference treatment.~      Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow~     Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in~     an intra-patient study.~      Secondary objectives~        -  To study the frequency of PPI.~        -  Compare the rate and extent of recurrence 6 months after completion of treatment.~        -  To study the occurrence of possible adverse effects.~        -  Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end~          of treatment).~        -  To study patient satisfaction on the effectiveness and tolerability of the study~          treatments.~      Methods Monocentric prospective interventional randomized split face comparative study~     between experimental treatment versus reference treatment.~      Intervention~        1. Visit Selection Patients will be selected from those presenting to the consultation of~          the department of dermatology at University Hospital of Nice. Participation will be~          offered to patients corresponding to the selection criteria of the study.~        2. Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin~          the study. This will ensure that patients signed informed consent. An initial clinical~          evaluation of melasma with calculation of MASI score and standardized photographs (see~          chapter 'assessment') will be made. An examination by confocal microscopy in vivo will~          be realized. All patients will receive treatment by stabilized kilnman trio for four~          weeks.~           In the week prior to Visit 1, the side of the face to receive the laser treatment will~          be determined by randomisation.~        3. Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The~          contralateral side will receive its first laser session. Given the results of analysis~          by intention to treat, the occurrence of serious side effects will result in~          discontinuation of treatment but monitoring will continue with the assessments.~        4. Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its second session. Patients continue the applications of~          cream on the contralateral side.~        5. Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its third session.Patients continue the applications of~          cream on the contralateral side.~        6. Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its fourth and final session. Patients continue the~          applications of cream on the contralateral side during 4 weeks.~        7. Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted. An~          assessment by in vivo confocal laser will be realized.~        8. Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted. An~          assessment by in vivo confocal laser will be realized.~        9. Visit V7 (final week 36):~      Clinical evaluation of melasma with calculation of MASI score and photographs will be made.~     Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser~     will be realized. The evaluation of safety and patient satisfaction will be performed using~     a visual analog scale.~      The primary endpoint will be the MASI score, score approved for assessment of melasma~     treatments.~   "
92226|NCT01850173|"~     The investigators designed the current study with the main objective of determining whether~     Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the~     functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD)~     patients referred to a rehabilitation programme.~   "
92227|NCT01850160|"~     This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy~     with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of~     adult patients with diagnosis of arterial hypertension.~   "
92228|NCT01850147|"~     The purpose of this study is to determine whether sequential application of low-dose~     short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung~     cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.~   "
92229|NCT01850134|"~     The objective of this trial is to evaluate a nutritional supplement for people with~     Diabetes.~   "
92230|NCT01850121|"~     The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg~     every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether~     IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year~     sustained the treatment effect. The study was started in 2003 an finished in 2008.~   "
92231|NCT01850108|"~     Allogeneic blood or marrow transplantation (alloBMT) is a curative therapy for a variety of~     hematologic disorders, including sickle cell disease and thalassemia. Even when it is clear~     that alloBMT can give to these patients an improvement in their disease, myeloablative~     transplants have important toxicities and mortalities associated. The lack of suitable~     donors continues to be a limit to access to transplantation. Substantial progress has been~     made recently in the development of pre-treatment regimens that facilitate the sustained~     engraftment of donor marrow with reduced toxicity. Most of these regimens incorporate highly~     immunosuppressive drugs, which allow the reduction or elimination of myeloablative agents or~     total body irradiation without endangering the sustained engraftment of HLA-identical~     allogeneic stem cells. Preliminary results of non-myeloablative allogeneic stem cell~     transplantation suggest that the procedure can be performed in patients who are ineligible~     for myeloablative alloBMT, and that sustained remissions of several hematologic malignancies~     can be obtained.~   "
92255|NCT01849796|"~     A study to determine if transcranial direct current stimulation (tDCS, the device that~     regulates brain activity, can improve pain in people with neuropathic facial pain and~     compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS~     over the motor cortex) can result in better pain-relief.)~   "
93639|NCT01831479|"~     This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and~     Olmesartan in healthy male volunteers~   "
92232|NCT01850095|"~     Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent~     studies have demonstrated an increase number of acne cases in adult women. These cases are~     predominantly normoandrogenic and have some clinical differences when compared with the most~     common group, the adolescent. The local glandular metabolism converts some hormonal~     precursors to more active substances that increase the sebum production, leaving these areas~     more prone to increase the colonization to Propionibacterium Acnes (P. Acnes). Toll-like~     receptor 2, expressed by inflammatory cells play a crucial role in the innate immune~     response to this bacterium. Previous studies confirm that exist a reduced expression of CD1d~     by keratinocytes in acne lesion, what can be interpreted as a low antigen-present function.~     The influence of hormonal alteration in the sebaceous glands could modulate the expressions~     of TLR-2 and CD1d explaining the persistence of lesions in adult women. The change to more~     estrogenic metabolism, with use of specific contraceptive pills could normalize this~     immune-mediated inflammatory process.~      Objective~      To analyze how the peripheral androgen conversion can influence the toll-like receptor 2 and~     CD1d expression in women with inflammatory acne before and after 6 months of oral~     contraceptives with anti-androgen activity.~   "
92233|NCT01850082|"~     Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the~     United States with over 300,000 cases performed each year. To restore blood flow to the~     heart, vascular conduits from another part of the body are procured to create a bypass~     around critically blocked coronary arteries. The left internal thoracic artery is the~     conduit of choice for CABG due to its superior long-term patency. However, almost all~     patients referred for CABG require additional grafts to provide complete revascularization.~     This necessitates the harvest of other vessels, most commonly the saphenous vein which is~     used almost ubiquitously in contemporary CABG with an average of two vein grafts per CABG~     procedure. In the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as~     the preferred method over the traditional open harvesting technique (OVH) because it~     provides a minimally invasive approach. However, more recent investigations indicate~     potential for reduced long-term bypass graft patency and worse clinical outcomes with EVH.~     The long term impact of EVH on clinical outcomes has never been investigated on a large~     scale using a definitive, adequately powered, prospective Randomized Controlled Trial (RCT)~     with long-term follow-up.~   "
92234|NCT01850069|"~     The aim of this study is to determine whether we can predict the intracranial pressure using~     near infra-red spectroscopy~   "
92235|NCT01850056|"~     The purpose of this study is to determine whether DEB is more effective than common PTA~     balloon in long-term vessel patency and inhibiting restenosis.~   "
92236|NCT01850043|"~     TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC~     recommendation. Participants with chest radiograph showing active TB lesion are excluded~     from this study.~   "
92237|NCT01850030|"~     Female inability to conceive a child. The purpose of this randomized, two-arm and~     double-blind study is to demonstrate that the treatment of a daily dose of 3x10mg~     dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized~     progesterone capsules administered intravaginally for the luteal support in patients~     undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until~     pregnancy is negative or until week 12 gestation.Patients will be followed during treatment~     until 30 days after delivery to record any safety and tolerability data of the patient and~     their newborn(s).~   "
92238|NCT01850017|"~     The investigators will conduct a prospective randomized double blind study comparing~     methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in~     two randomized groups. The investigators plan to document the intraoperative opioid~     requirements, time to first dose of opioids postoperatively and total opioid consumption in~     the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will~     be assessed.~   "
92239|NCT01850004|"~     The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia~     (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib~     treatment are able to maintain a sustained remission in the long-term, with undetectable or~     minimally detectable BCR-ABL residual disease.~   "
92240|NCT01849991|"~     This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with~     colic. The study is being conducted in order to prove treatment dose with probiotic~     (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.~   "
92241|NCT01849978|"~     This study will examine whether or not providing early stage breast cancer survivors with~     tips on making exercise more enjoyable promotes greater levels of moderate to strenuous~     exercise.~   "
92242|NCT01849965|"~     To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound~     closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active~     ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus~     (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.~   "
92243|NCT01849952|"~     MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes.~     Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas,~     known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b~     (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue.~     This study tests the hypothesis that in primary glioma samples mir-10b expression patterns~     will serve as a prognostic and diagnostic marker. This study will also characterize the~     phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the~     critical function of anti-mir-10b in blocking established glioblastoma growth, the~     investigators will test in vitro the sensitivity of individual primary tumors to~     anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from~     patients diagnosed with gliomas over a period of two years. These samples will be examined~     for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic~     variations will be correlated to mir-10b expression levels.~   "
92256|NCT01849783|"~     This phase II trial investigates whether patients greater than or equal to 65 years of age~     diagnosed with myeloma or another plasma cell malignancy will have better outcomes with~     transplant followed by maintenance therapy, as primarily measured by progression-free~     survival, versus non-transplant approaches.~   "
92244|NCT01849939|"~     Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However,~     the diagnosis in young patients become more frequently with poor prognosis. The~     identification of new prognostic factors permits early determination of the high risk~     population and provide them the therapeutic intensification. Allogeneic transplantation of~     hematopoietic stem cells transplantation (AHSCT) allows to long-term remission and in some~     cases complete and definitive eradication of the disease. After chemotherapy or antibodies,~     the Minimal Residual Disease (MRD) negativity is associated with better disease-free~     survival. MRD negativity occurs in some patients with the appearance of GVHD, stopping the~     immunosuppression or after donor lymphocyte injection (DLI). The negativity of MRD in the~     first year post-transplant is correlated with better progression-free survival or overall~     survival (Dreger 2010, Farina 2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be~     an objective after AHSCT. The aim of this prospective study is to evaluate a standardized~     preemptive immunointervention of post-allograft immunosuppressive therapy modulation and DLI~     administration according to MRD level. The objective is to obtain MRD negativity at 12~     months after AHSCT.~   "
92245|NCT01849926|"~     Although uncomplicated cystitis is considered to be a mild condition and mostly self~     limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are~     known to give a quick relief of symptoms and shorten the course of the condition by a few~     days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of~     uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to~     see whether symptomatic treatment with ibuprofen is equally efficient as treatment with~     mecillinam in this group.~   "
92246|NCT01849913|"~     The aim of the proposed study is to investigate the effects of low-level laser therapy on~     neck pain.~   "
92247|NCT01849900|"~     This study examines the efficacy of the Preconception Reproductive Knowledge Promotion~     (PREKNOP) intervention, designed to promote women's reproductive health and positive~     pregnancy outcomes. The study's goal is to educate low-income women about reproductive~     changes related to their menstrual cycle. The main hypothesis of the study is that women who~     receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and~     increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning~     ability.~   "
92248|NCT01849887|"~     Stroke is a major cause of adult disability. Currently approved reperfusion therapies are~     provided to only a small percentage of patients in the U.S. New therapies are needed that~     improve outcome and that can be accessed by a majority of patients. Animal studies suggest~     that bone marrow-derived mesenchymal stem cells, administered intravenously days after a~     stroke, safely improve long-term behavioral outcome. A large human experience suggests the~     safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to~     assess the safety of this therapy in patients with recent ischemic stroke.~   "
92249|NCT01849874|"~     The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during~     which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary,~     fallopian tube or primary peritoneum will receive either investigational study drug MEK162~     or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan).~     Patients will be followed to compare the effectiveness of the study drug to that of the~     selected chemotherapies. Patients may be eligible to crossover from physician's choice~     chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed~     disease progression. Approximately 360 patients from North America, Europe and Australia~     will be enrolled in this study.~   "
92250|NCT01849861|"~     The purpose of this study is to correlate in an elderly population (≥ 65 years), the~     different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive~     symptoms and cognition. And assess whether the increased serum TSH to the upper half of the~     normal range, through the use of antithyroid drugs, is associated with improvements in these~     parameters.~   "
92251|NCT01849848|"~     The purpose of this study is to determine the antitumor efficacy and safety of bendamustine~     (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration~     for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory~     multiple myeloma.~   "
92252|NCT01849835|"~     The purpose of this randomized controlled trial (RCT) is to compare the two ways~     (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive~     detection, complications, pain level, operation time and costs et al.~   "
92253|NCT01849822|"~     This research study is being done to develop a brain controlled medical device, called a~     brain-machine interface or BMI, that will provide people with a spinal cord injury some~     ability to control an external device such as a computer cursor or robotic limb by using~     their thoughts.~      Developing a brain-machine interface (BMI) is very difficult and currently only limited~     technology exists in this area of neuroscience. The device in this study involves implanting~     very fine recording electrodes into areas of the brain that are known to create arm movement~     plans and provide hand grasping information. These movement and grasp plans would then~     normally be sent to other regions of the brain to execute the actual movements. By tying~     into those pathways and sending the movement plan signals to a computer instead, the~     investigators can translate the movement plans into actual movements by a computer cursor or~     robotic limb.~      The device being used in this study is called the NeuroPort Array and is surgically~     implanted in the brain. This device and the implantation procedure are experimental which~     means that it has not been approved by the Food and Drug Administration (FDA). One NeuroPort~     Array consists of a small grid of electrodes that will be implanted in brain tissue with a~     small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This~     pedestal is designed to be attached to the skull and protrude though the scalp to allow for~     connection with the computer equipment.~      The investigators hope to learn how safe and effective the NeuroPort Array is in controlling~     computer generated images and real world objects, such as a robotic arm, using imagined~     movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.~   "
92254|NCT01849809|"~     A research study of the effectiveness and safety of gamma knife ventral capsulotomy in~     patients with severe intractable obsessive-compulsive disorder (OCD).~   "
94027|NCT01826370|"~     This is a prospective, non-interventional, open label, multi center, post marketing~     surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin~     among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24~     weeks.~   "
92259|NCT01849744|"~     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal~     adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This~     clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The~     purpose of this study is to evaluate the safety (including the recommended Phase II dose),~     pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of~     VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your~     body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.~   "
92260|NCT01849731|"~     The purpose of this cluster randomized trial is to determine whether an intervention~     implemented in a General Surgery, based in improving patient-provider communication, results~     in a better diabetes self-management in patients with lower educational level. A secondary~     objective is to assess whether telephone reinforcement enhances the effect of such~     intervention.~   "
92261|NCT01849718|"~     This research project deals with stress treatment in the form of garden therapy in the~     therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is~     specially designed for the treatment of stressed people.~      Nacadia-therapy can be described as a process in which the patient's health and well-being~     is assumed to enhance by the presence of the natural environment and through participating~     in meaningful gardening activities.~      NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized~     and longitudinal studies of the effects of Nacadia-therapy compared to acknowledged~     cognitive behavioral therapy (CBT).~      The outcome measures for example consist of: ability to return to work, health care use,~     psychological measurements related to stress, health, quality of life and changes in~     medication use. Further, exploratory studies of the garden therapy in the form of~     observations and interviews will be performed, to get a better understanding of the garden~     and the garden activities' importance for the therapeutic purposes.~      Hypothesis:~      - garden therapy, in a designed natural environment, will lead to improved health and~     well-being for people who are off sick with stress-related disorders~   "
92262|NCT01849705|"~     Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic~     obesity, and can explain 2-6% of severe obesity.~      Studies have shown that mutations in MC4R are associated with increased fat mass,~     height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R~     are less penetrant for these phenotypes but it has been observed that individuals with MC4R~     mutations have a smaller than expected blood pressure for their degree of obesity.~      The purpose of this study is to explore the association between functional MC4R mutations~     and obesity, insulin resistance and blood pressure.~   "
92263|NCT01849692|"~     The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a~     microvolume injection or infusion on retinal function and morphology in subjects with~     exudative age-related macular degeneration (AMD).~   "
92264|NCT01849523|"~     Background Physical as well as psychosocial complaints are frequently present in patients~     with a neuroendocrine tumor (NET). Adequate information is seen as an essential aspect of~     supportive care. The aim of the current study is to test the effectiveness of a web-based~     tailored information and support system targeting patients' information and care needs. Key~     features of this system are self-screening of physical and psychosocial problems, tailored~     education on reported problems and self-referral to professional health care.~      Objective To detect whether a web-based tailored information and support system improves~     patients' perception and satisfaction of received information. The investigators hypothesize~     that after having received web-based tailored information and support patients feel more~     informed and are more satisfied with the received information than when receiving standard~     care.~      Study design The present study is a randomized prospective longitudinal experimental~     multicenter pilot study. In this study, we want to examine the effect sizes on the~     perception and satisfaction by the patient of received information (primary objective) and~     secondary objectives after having used web-based tailored information and support. Eligible~     are newly diagnosed NET-patients (N=40) (diagnosed less than 3 months ago). Patients will be~     asked to fill out questionnaires at baseline and after 12 weeks, on socio-demographic~     features (only at baseline), internet use (only at baseline), health care use, patients'~     perception and satisfaction of received information, distress, quality of life and~     empowerment (only after 12 weeks).~      Study population Patients diagnosed with a NET (any type of NET, any phase of disease) who~     are under treatment at the Department of Medical Oncology in the University Medical Center~     Groningen or Hospital Medisch Spectrum; twenty will be invited to participate in the study.~      Intervention During 12 subsequent weeks, a personalized website (with a surname/password)~     will become available to patients in the experimental group beside the usual standard care.~     Key features of the website are self-screening, tailored patient education and~     self-referral. Self-screening will be performed by an online version of the Dutch Distress~     thermometer (DT) and Problem List (PL). Patients will receive automated feedback on their DT~     score immediately after test completion together with information regarding problems~     reported on the PL, options for (self)-help and possibilities for referral to professional~     care. Contact information will also be available to discuss questions, problems and/or~     referral needs. Patients may also request a telephone call.~      Main study endpoint The primary endpoint is to detect an improvement in patients' perception~     and satisfaction of received information after having received web-based tailored~     information and support.~   "
92265|NCT01849510|"~     Spinal metastases indicate for an incurable course of disease. Local tumor control after~     palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30%~     of patients, therapy fails locally within two years associated with further symptoms that~     are difficult to treat, because a further radiation of already radiated vertebra leads to a~     higher rate of myelitis. This trial aims to improve local tumor control and control of pain~     by radiotherapy with increase in total and single dose. Dose elevation is realized by~     simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT &~     hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy).~     Primary endpoint is local tumor control (time up to progression). Secondary endpoints are~     pain control associated with quality of live, severity of acute and chronic adverse effects~     and overall survival. It is planned to recruit a total number of 155 patients.~   "
92266|NCT01849497|"~     The primary objective of this study was to assess users' ability to administer a full dose~     of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.~   "
92267|NCT01849484|"~     This randomized trial examines possible enhancements in live quality and neurocognitive~     functions in patients after radiotherapy of the neurocranial area with hippocampal sparing.~     Although the hippocampus has a crucial role in regard to neurocognition and memory,~     hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far.~     Brain metastases in the hippocampal region are very rare and an infiltration of the~     hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is~     very high. This study aims to reduce the radiation dose in the hippocampal region to improve~     the quality of live and neurocognitive functions in patients without degrading prognosis or~     increasing probability of brain metastases in hippocampal region.~      Primary endpoint of the trial is quality of live and neurocognitive functions in patients~     after radiation of neurocranial region with hippocampal sparing compared with conventional~     radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are~     cerebral recurrence rate in hippocampal region and overall survival. It is planned to~     include a total number of 150 patients.~   "
92268|NCT01849471|"~     This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic~     effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous~     and interstitial radiotherapy are included. Beside medical effects and adverse events, it's~     prospectively needed to extensively inform patients about socioeconomic aspects associated~     with radiotherapy. The interrogation comprises to collect possible costs and expenditures~     during and after therapy. Aspects especially concerning post therapy period include~     additional consultations, individual applied alternative medical care, need for additional~     medical aids (salves, medicine, bandages) and changes in professional and social situation.~     It's figured out in what extend costs are absorbed by health insurance coverage. In Germany~     there is no appropriate trial with respective patient population and respective therapy.~     Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as~     changes in social and professional situation. Secondary endpoints are quality of life,~     adverse events of therapy and the correlation of quality of life, adverse events and~     economic aspects for the patient and the health insurance coverage.~   "
92269|NCT01849458|"~     The aim of this study is to collect and report data from a consecutive series of patients~     implanted with these products as part of a post-market surveillance plan for CE Mark~     approval in the European Union.~   "
92270|NCT01849445|"~     The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee~     replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of~     patients are not satisfied after TKA. This project will look to find out if the research~     team can identify patients who will not recover well at an earlier stage, so that these~     patients can be helped sooner.~      The study will try to determine if doing intense physiotherapy with patients who are not~     doing well at the first review (6 weeks after their operation) can improve how well they~     have recovered at one year.~   "
92271|NCT01849432|"~     A diverse body of research has implicated the amygdalo-cortical circuitry in the~     pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated~     amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of~     amygdala responses by specific cortical regions, including the pregenual anterior cingulate~     cortex, subcallosal cortex, and hippocampus.~      The investigators propose to investigate the pathophysiology of several specific anxiety~     disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific~     Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to~     probe the function and structure of implicated amygdalo-cortical circuitry.~   "
92272|NCT01849419|"~     The main aim of the study is to investigate the effects of~     ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in~     healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans~     reporting use of the drug in 2006. With this number of users, and evidence that high doses~     of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use~     may be substantial. Certain subjective effects of this drug distinguish it from other~     stimulants, and may contribute to its widespread use: That is, users report that ecstasy~     produces profound feelings of empathy and closeness to others. These so-called~     'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of~     the drug, have yet to be characterized in controlled laboratory studies. The investigators~     propose to characterize the effects of MDMA on measures of social and emotional processing~     that may contribute to this 'empathogenic' profile, including measures of emotion~     recognition, emotional responsiveness and sociability. The investigators will assess effects~     of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in~     100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears~     to produce pro-social behavioral effects resembling those attributed to MDMA.~   "
92273|NCT01849406|"~     It is anecdotally well known that patients snore more when their nose is blocked. However,~     the therapeutic effect of improving nasal airway patency on snoring indices remains a point~     of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and~     failed to show any improvement in the number of snores after its application, although~     apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that~     dilation of the anterior nares in patients without nasal pathology has a relatively weak~     effect on snoring, and routine use of nasal dilating appliances was not recommended for the~     treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids~     have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep~     apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids~     on snoring indices.~      Additionally, the present authors have demonstrated a strong correlation between~     apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal~     nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively~     have decreased nasal breathing epochs.~      It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might~     be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal~     steroids might also increase nasal breathing epochs and lead to decreased snoring indices in~     patients who had decreased nasal breathing before the administration of nasal steroids.~      Patients will be randomized in two groups: the patients of the first group will undergo a~     one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one~     week of nasal normal saline. The patients of the second group will undergo a one week~     therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of~     nasal budesonide. Before and after each treatment regimen patients will undergo an~     assessment, which will consist of anterior rhinomanometry and polysomnography with~     concomitant measurement of snoring indices and breathing route pattern.~      The investigators hypothesize that the application for one week of nasal budesonide has a~     beneficial effect on snoring indices in patients who present before the application~     decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in~     increasing nasal breathing epochs.~   "
92274|NCT01849393|"~     The primary objective of this project is to assess the study population's acceptance of two~     medication adherence support strategies: incentive-based programs and electronic medication~     monitoring. The study population is adolescents (ages 16 - 24) positive for human~     immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St.~     Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio~     Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be~     10-20 minutes. Patient identifiers will not be attached the survey.~   "
92275|NCT01849380|"~     S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine~     drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil),~     and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low~     gastrointestinal toxicity. Several studies have proved the safety and efficacy of single~     agent S-1 in metastatic breast cancer. This study is designed to further investigate and~     compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs.~     Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients~     with local advanced breast cancer.~   "
92276|NCT01849367|"~     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression~     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled~     trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be~     measured during the trial.~   "
92277|NCT01849354|"~     The women's clinic at Turku University Hospital has also since year 2000 accomplished and~     systematically increased advanced surgical treatment for the endometriosis patients with~     difficult disease. The aim is to centralize endometriosis treatment in the hospital district~     and by doing that be able to offer exact diagnosis, advanced surgical treatment and~     infertility treatment for every patient in the hospital area. The main purpose of this study~     is to find out how the operative treatment of endometriosis patients in Turku University~     Hospital is functioning and to see how the quality of life of these patients is before and~     after the surgery. Furthermore, the structure of the endometriosis patients' endometrium and~     the different markers of blood and urine are studied.~   "
92278|NCT01849341|"~     It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into~     2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention~     group was based on the administration of roflumilast 500 mcg per day on alternate days~     (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake~     the treatment according to the standard dosage (roflumilast 500μg od).~      The patient monitoring will be done by one of the sub-investigators fully independent team~     that started the medication keeping the pattern masking by single blind, and since it aims~     to assess the frequency of adverse events (AEs) in both groups were collected systematically~     different AEs and their characteristics at 15 days (V1), and from that moment a month (V2)~     and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities,~     home treatment, anxiety and depression and quality of life).~      The purpose of this study is to assess whether the administration of roflumilast by a~     gradual pattern varies the incidence of discontinuations due to adverse events when compared~     with the usual dosage.~   "
92279|NCT01849328|"~     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the~     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software~     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the~     best discrimination between Breast Cancer sick population and healthy population. The gold~     standard for identifying sick/healthy population is biopsy proven breast cancer.~   "
92280|NCT01849315|"~     Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010).~     Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to~     the national average (20.9% vs. 15.4%), which increases their risk of obesity-related~     diseases (Montgomery-Reagan, Bianco, Heh, Rettos, & Huston, 2009). Although physical~     activity (PA) is known to improve fitness and adiposity (Gutin & Owens, 2011; Yin et al.,~     2009), very little is known about the effects of PA on the progression of chronic disease~     risk factors (biomarkers) for obesity-related diseases in children, such as inflammatory~     markers, lipids, and glucose/insulin. This lack of knowledge is due to a limited~     understanding of the number of calories burned during children's free-play PA. This study~     will assess the impact of a PA program (ACT) of known energy cost on obesity-related disease~     markers in 2nd-4th grade children compared to a sedentary control group (SED). The study~     will recruit children from an after-school program in Athens County elementary schools.~     Baseline and posttest data will include measures of height, weight, body composition, blood~     pressure, and physical activity levels. Following baseline measures, children will be~     randomized into either the ACT or SED group for 8 weeks. The ACT group will play recess-type~     games previously determined to expend ≥100 calories in 30 minutes. The SED group children~     will play sedentary-type activities during the same time period. It is hypothesized that the~     ACT group children will demonstrate significant improvements in PA after 8 weeks compared to~     the SED group children and that these improvements will be related to positive changes in~     body weight and body composition.~   "
92281|NCT01849302|"~     Over the last decades, changes in the diet and lifestyle have led to overall energy~     imbalance becoming commonplace and the emergence of an obesity epidemic with more than 1.6~     billion adults being overweight.~      Consumption of foods that can affect appetite by increasing satiety could regulate the total~     energy intake and thus body weight. There is data suggesting that the macronutrient~     composition of the foods and especially protein content may have a potent role on satiety.~     However, it is difficult to pinpoint the optimum quantity needed to observe significant~     effects of protein on satiety.~      The research project is dedicated to identify which food components [proteins, carbohydrates~     (CHO), fats] and the optimized protein quantity needed to accelerate satiation, suppress~     appetite and extend satiety until hunger appears again.~      It is hypothesized that the consumption of protein-enriched meals will induce a reduction in~     hunger through the impact on gut hormones and peptides that are closely related to the~     short-term regulation of food intake.~   "
92282|NCT01849289|"~     This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the~     trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin~     naïve subjects with type 2 diabetes.~   "
92283|NCT01849276|"~     The purpose of the study is to determine if metformin in combination with cytarabine is safe~     and effective. Participants in this research study have acute myeloid leukemia (AML) that~     has come back after initial treatment or has not gone away with initial therapy.There is~     evidence that metformin directly kills leukemia cells. Laboratory data have also shown that~     combinations of metformin with cytarabine are more efficient than each agent alone in~     killing leukemia cells in the laboratory.~   "
92284|NCT01849263|"~     This phase II trial studies how well ibrutinib works in treating patients with follicular~     lymphoma that has come back after a period of improvement or does not respond to treatment.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
92285|NCT01849250|"~     This randomized phase II trial studies how well docosahexaenoic acid works in preventing~     recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent~     recurrence in breast cancer survivors.~   "
92393|NCT01847807|"~     Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In~     this study, prospective randomized, controlled, parallel designed ,different doses of~     Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time~     quantitative PCR and Western Blotting to detect the index of oxidative stress~     、angiotensin-converting enzyme 2 mRNA expression and proteins.~   "
94039|NCT01826214|"~     The study will evaluate the efficacy, safety and tolerability of two dosing schedules of~     LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with~     untreated acute leukemia.~   "
92286|NCT01849237|"~     Septic shock remains a significant clinical problem associated with high rates of mortality~     among neutropenic patient despite antimicrobial therapy and supportive care. Recently,~     mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC~     treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial~     therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of~     inflammation and inflammation-related genes (such as interleukin-10, interleukin-6).~     Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on~     experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment~     to reduce sepsis-related mortality.~      The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after~     bone marrow transplantation.~      This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation~     and mortality in patients with septic shock and severe neutropenia.~      The main goal of the study is to evaluate the impact of MSCs therapy on organ~     dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock~     and severe neutropenia. All patients will be randomized in two groups: control group~     (standard treatment of septic shock) and MSCs-group (standard treatment of septic shock +~     MSCs infusion of 1-2 millions/kg/ day).~   "
92287|NCT01849224|"~     The primary outcome is the change in lower extremity edema-related symptoms. Secondary~     outcomes include the compliance rate of management guidelines for lower extremity edema, the~     performance rate for pelvic and lower extremity exercise.~   "
92288|NCT01849211|"~     Difficult mask ventilation might lead to a life-threatening situation, if endotracheal~     intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous~     ventilation. However, controversies exist if NMBA improve or impede face mask ventilation.~     Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors~     for difficult face mask ventilation.~   "
92289|NCT01849198|"~     Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed~     at the M. adductor pollicis. However, many operations require positioning of the patients~     with arms attached to the body. In these situations, the anaesthesiologist has no access to~     the m.adductor pollicis.~      In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the~     n. accessorius with accelerometry of the m. trapezius.~   "
92290|NCT01849185|"~     The primary objective is to examine whether probiotics given to hypercholesterolemic~     patients treated with statins, would further decrease LDL-Cholesterol levels.~      The secondary objective is to examine whether adding of probiotics to statins would decrease~     fasting glucose levels and glycolysated hemoglobin~   "
92291|NCT01849172|"~     The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms~     of menopausal transition .~   "
92292|NCT01849159|"~     Actively developing stem cells (SCs) transplantation techniques cause natural interest to~     the problem of regeneration in the lungs. Numerous experimental studies proved the benefits~     of different types of SCs in experimental models of pulmonary emphysema (PE).~      G. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats~     with papain-induced emphysema leads to their migration into the lungs, differentiation into~     type 2 alveolocytes, and inhibition of apoptosis and prevention PE.~      K. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes~     and endothelial cells apoptosis decreased after adipose SCs intravenous administration to~     mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade.~     The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the~     alveolar wall and peribronchial interstitium and release integrins, extracellular matrix~     components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and~     transforming growth factor β2.~      Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the~     development of elastase-induced emphysema in rats at different terms of transplantation.~      After the success of pilot studies have started clinical trials. Currently, the website~     http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of~     MSC transplantation in patients with COPD and emphysema. Two of them have already been~     completed and the results of the first pilot project published.~      Authors on the example of 4 patients showed a complete absence of adverse effects, improved~     quality of life and stability of functional parameters at 12 months after starting treatment~     One of the problems of MSC transplantation in patients with respiratory failure is an~     accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines~     and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases~     their survival in hypoxic conditions, increases the expression of growth factors and~     antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a~     significant positive effect on the disease.~   "
92293|NCT01849146|"~     This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 when~     given together with radiation therapy and temozolomide in treating patients with newly~     diagnosed or glioblastoma that has come back. WEE1 inhibitor AZD1775 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses~     high energy x rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such~     as temozolomide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving WEE1~     inhibitor AZD1775, radiation therapy, and temozolomide may work better in treating patients~     with newly diagnosed or recurrent glioblastoma.~   "
92294|NCT01849133|"~     The purpose of this study is to investigate the efficacy of exclusive intraoperative~     radiation therapy after conserving surgery in early-stage breast cancer compared with whole~     breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any~     recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence~     occurring in quadrants other than the previous one) and the recurrence free survival.~   "
92313|NCT01848886|"~     Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties~     gone through a revival. The initially reported worse outcome in RA graft patients compared~     to patients grafted with the saphenous vein (SV) has since been corrected. Studies have~     shown better patency when using RA, so the RA is going to be preferred more and more~     especially in younger patients where long time patency is critical. During the last 10 years~     endoscopic techniques to harvest the RA have evolved. Multiple different techniques have~     been used, but now the equipment and technique have been refined and are highly reliable.~     The investigators hypothesize that the endoscopic technique has less complications and a~     just as good patency as open harvest. There are also two possible ways to use the RA as a~     graft. One way is sewing it onto the aorta and another way is sewing it onto the mammarian~     artery. The investigators hypothesize that using it on the mammarian artery is superior as a~     revascularisation technique with just as good a patency as sewing it directly onto the~     aorta.~   "
92314|NCT01848873|"~     To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and~     plasma homocystein.~   "
92295|NCT01849120|"~     Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for~     congenital heart disease are at great risk for experiencing life-threatening low cardiac~     output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and~     inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is~     LCOS that is responsible for the majority of early postoperative deaths in this population~     of neonates and infants. Improved pediatric probes placed in peripheral locations using near~     infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations~     reflecting overall perfusion and oxygen balance in the tissues. Following parental or~     guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart~     disease will be enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be~     placed on the flank, lower extremities and the forehead. Continuous NIRS saturations will be~     monitored and stored for analysis. Point of care (POC) lactates will be obtained after~     admission to the intensive care unit (ICU) every 2 hours for the first 24 hours~     postoperatively, then once at 48 hours. The association between NIRS oxygen saturation and~     POC lactate values will be assessed using mixed linear models taking into account the~     repeated measures design. Exploratory analyses will be performed to assess whether NIRS~     oxygen saturation is associated with outcomes such as days in ICU, adverse events and~     mortality.~      The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac~     output will allow better and earlier therapy for neonates and infants following cardiac~     surgery.~   "
92296|NCT01849107|"~     Small bowel irradiation results in epithelial cell loss and consequently impairs function~     and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The~     investigators evaluate the correlation between plasma citrulline level, dose-volume~     histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for~     Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as~     a biomarker for quantifying radiation-induced epithelial cell loss.~   "
92297|NCT01849094|"~     To determine the pharmacokinetic profile of a new (extended release) formulation of~     milrinone and to demonstrate evidence of hemodynamic effect~      Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort)~     - to demonstrate evidence of haemodynamic benefit~      Study Design: Open label~   "
92298|NCT01849081|"~     We are doing this research study to evaluate whether continuous positive airway pressure~     (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea~     is a disease where a person has interruptions in their breathing while they are sleep. This~     can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high~     pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known~     treatment for sleep apnea.~   "
92299|NCT01849068|"~     Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence~     from in vitro systems and animal models suggest that this effect is associated with an~     increase in low-density lipoprotein (LDL) receptor expression in the small intestine. The~     impact of a treatment with ezetimibe on intestinal gene expression and protein mass levels~     of LDL receptor and other key genes involved in intestinal cholesterol homeostasis will be~     examined in dyslipidemic men with insulin-resistance. In the present study, gene expression~     studies and protein mass levels will be assessed on duodenal biopsies by real-time~     polymerase chain reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS),~     respectively. The primary objective of this proposal is to examine the effects of ezetimibe~     on intestinal gene expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in~     dyslipidemic men with insulin-resistance. The secondary objective is to examine the impact~     of ezetimibe treatment on intestinal gene expression and protein mass levels of sterol~     regulatory element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding~     cassette gene (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and~     3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.~      Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal~     mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.~      Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal~     mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in~     dyslipidemic men with insulin-resistance.~   "
92300|NCT01849055|"~     This is a study of LY3023703 in healthy participants. The purposes of this study are to look~     at safety, how well the study drug is tolerated, how much of the study drug gets into the~     blood stream and how long it takes the body to remove the study drug. The effects of~     LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any~     side effects that occur will be collected. The study is expected to last 21 weeks.~   "
92301|NCT01849042|"~     This study will evaluate the pharmacological efficacy on language capability and compliance~     with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients~     with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of~     memantine on language capability in moderate to severe Alzheimer's disease patients who are~     taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of~     maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short~     form in probable AD.~   "
92324|NCT01848743|"~     In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the~     leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering~     immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some~     are mild but some developed hepatic decompensation or even death.~      Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl~     can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine~     was found to have better survival than entecavir in chronic HBV with severe AE. Recent study~     from India found that tenofovir is able to improve survival in chronic HBV with severe AE.~     The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV~     with severe AE.~      The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for~     more than 6 months. Severe AE was defined as ALT > 400 U/L, prolongation of prothrombin time~     > 3 seconds, bilirubin > 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or~     alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or~     previous use of anti-HBV agents are excluded. All enrolled patients are randomized into~     group A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100~     mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and~     virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144~     weeks. The values are expressed as mean + SD. Categorical variables were analyzed with~     Chi-square test or Fisher's exact test as appropriate and continuous variables were analyzed~     by Mann-Whitney test. Logistic regression test was applied to analyze the independent~     association of various variables with outcome. A p value < 0.05 was regarded as significant.~   "
92302|NCT01849029|"~     Many American Indian (AI) women never receive services for serious mental health problems~     resulting from traumatic events, violence exposure and maltreatment. AI women suffer higher~     lifetime rates of Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with~     excessive drinking and risky sexual behaviors. These factors magnify risk for human~     immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with~     tribal partners, this application, proposes a 3-year project to culturally adapt and pilot~     an empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for~     PTSD, substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the~     investigators will assess the feasibility, acceptability and treatment fidelity of~     delivering CPT via AI community health workers in a resource-limited tribal reservation.~     This project brings a culturally responsive intervention to an understudied and highly~     vulnerable population. Its significance lies in its potential to advance science in the area~     of PTSD, substance use treatment and HIV/STI prevention among AI women. Study data would~     benefit tribal and rural communities and the mental health field. Finally, it is geared~     toward developing the research infrastructure and mental health treatment capacity serving~     AI women living in rural settings, a group at risk for an expanding HIV/AIDS epidemic. If~     successful, findings from this pilot will provide evidence for a larger effectiveness trial.~      The AIMS are AIM I. Adapt the evidence-based CPT intervention in full collaboration with~     tribal partners. This will be done in accordance with the CDC's Map of Adaptation Process~     and involves formative research with tribal leaders, potential consumers, providers, and~     health care administrators using qualitative methodology.~      AIM 2. Assess this intervention delivered by Native American community health workers for~     feasibility and acceptability in a resource-limited rural reservation setting.~      AIM 3. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a~     12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using~     AI women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an~     effect size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use;~     (c) high risk sexual behavior.~   "
92303|NCT01849016|"~     The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the~     frequency of pain in daily life in patients with Sickle Cell Disease (SCD).~      Pain is an invalidating hallmark of this disease and has a considerable impact on the~     Quality of Life of patients and the medical health care system. Oxidative stress is~     hypothesized to play a central role in its pathophysiology. In pilot studies the~     administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress.~     Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a~     small pilot study in patients with SCD.~      This study will be performed as a multicenter, randomized, controlled trial where patients~     will be treated with either NAC or placebo for a period of 6 months. The investigators~     expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving~     their quality of life and participation in society.~   "
92304|NCT01849003|"~     This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval~     in participants with Long QT-3 syndrome. This study will be performed in six cohorts of~     participants in a sequential manner, four single-dose cohorts followed by two multiple-dose~     cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be~     1 day and 7 days, respectively. Participants will be confined at the study center from~     check-in until completion of assessments at discharge.~      Participants will be continuously monitored using real-time telemetry throughout the~     in-clinic confinement. Physical examinations including vital signs, laboratory analysis,~     electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed~     at defined time points throughout the study period. Assessment of adverse events and~     concomitant medications will continue throughout the duration of the study.~   "
92305|NCT01848990|"~     The primary objectives of this study are to compare the difference in glycosylated~     hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in~     continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the~     safety of Hylenex recombinant preadministration, including local tolerability, adverse~     events, and hypo- and hyperglycemia rates.~   "
92306|NCT01848977|"~     Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two~     device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA).~     Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is~     performed. The investigators will compare the Invos® data to InSpectra™ to investigate~     whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.~   "
92307|NCT01848964|"~     This study aims at evaluating the relation between quality of the interface between the~     stump and the prosthesis, and the quality of gait in above-knee amputees.~      The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee~     amputees corresponds to an homogeneous pressure distribution pattern onto the stump.~   "
92308|NCT01848951|"~     This study intends to examine this rational by comparing the infiltrative~     transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal~     surgery . The efficacy of the TAP block for abdominal surgery is well documented in the~     literature (McDonnell 2007) (Kadam 2011), but there are no studies utilizing long-acting~     bupivacaine. The investigators believe the primary outcome will demonstrate no difference~     between the two in terms of pain scores and opioid consumption. The investigators anticipate~     that patients who have undergone TAP blocks will have improved secondary outcomes with~     respect to a decreased costs, urinary retention, and hypotension.~   "
92309|NCT01848938|"~     The purpose of this study is to determine whether treatment of stress urinary incontinence~     (SUI) via smartphone is effective.~   "
92310|NCT01848925|"~     The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in~     patients suffering from Sickle Cell Disease.~   "
92311|NCT01848912|"~     The purpose of this study is to find a way of detecting infection earlier in patients~     receiving bone marrow transplant. This is accomplished by continuous individualized~     monitoring of heart rate, respiratory rate and temperature variability in this patient~     population. The investigators are collecting data to determine whether or not subtle~     differences in heart rate, respiratory rate and temperature will help physicians to detect~     infection earlier in order to begin faster treatment before a patient's condition~     deteriorates. Blood tests will also be performed to check for certain biomarkers that may~     indicate infection~   "
92312|NCT01848899|"~     The aim of this study is to determine how two different types of iodinated contrast media~     (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect~     specific markers of thrombogenesis and platelet function in patients undergoing coronary~     angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during~     percutaneous coronary intervention (PCI), affects any contrast-related changes in~     thrombogenesis and platelet function.~   "
92325|NCT01848730|"~     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain~     experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three~     weeks of treatment compared to the baseline period.~   "
92315|NCT01848860|"~     Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung~     disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the~     lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated~     in patients with recurrence or persisted air leakage. In recent years, thoracoscopic~     bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic~     instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is~     around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of~     postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax~     and prolonged air leakage are missed bleb surrounding the endoscopic suture line or~     suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications,~     a novel method using coverage of the endoscopic suture line by a large absorbable mesh~     during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can~     strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce~     the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the~     investigators are conducting a prospective randomized trial in National Taiwan University~     Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax~     who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or~     not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The~     primary endpoint is to compare the rate of pneumothorax recurrence within one year between~     the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term~     pulmonary function between the two groups.~   "
92316|NCT01848847|"~     The purpose of the study is to investigate the advantages and disadvantages of bladder~     filling during hysteroscopy procedure.~   "
92317|NCT01848834|"~     This study is being done to investigate the safety, tolerability and anti-tumor activity of~     pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC)~     (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer~     (Cohort C), or advanced gastric cancer (Cohort D)~   "
92318|NCT01848821|"~     The aim of this study is to evaluate the speed and quality with which OASIS® Ultra~     (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical~     sized defect. The investigators intend on confirming the histological composition of the~     dermal substitute in order to delineate the amount of cellular recruitment, collagen~     deposition and neovascularization present compared with control wounds. The investigators~     hypothesize that OASIS® Ultra will provide a faster healing time as well as the~     re-establishment of a dermis for further skin graft application. The investigators~     anticipate that our study will define parameters for the application of OASIS® Ultra as well~     as potentially demonstrating the advantages in healing time, healed wound quality and~     hospital stay.~   "
92319|NCT01848808|"~     The general objective of this project is to examine the impact of Wobenzym PS~     supplementation on blood markers of inflammation and inflammation gene expression in~     volunteers with sub-clinical inflammation.~      The study will be undertaken according to a double-blind, cross over, randomized, placebo~     controlled design. The study will involve men and women with subclinical inflammation~     (n=24). Eligible subjects will have blood CRP >1 mg/L and <10 mg/L and will be in good~     health. The impact of Wobenzym PS on inflammation (vs. placebo) will be assessed by~     comparing the blood fasting concentrations and whole blood gene expression of anti- and~     pro-inflammatory proteins before and after the 4-week supplementation (Wobenzym and~     placebo). The two 4-week supplementation will be separated by a 4-week wash out period.~   "
92320|NCT01848795|"~     Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured~     or improved following bariatric surgery. This could be explained by weight loss or by~     changes of nutrient absorption or gut hormone secretion. The comparison of glucose~     metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this~     matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical~     procedures while the endoscopically placed intragastric balloon induces weight loss with a~     mechanical action.~      The present study hypothesis is that the bypass of the first portion of the intestine~     obtained with the EndoBarrier will be more effective in improving glucose metabolism than~     the reduction of food intake obtained with the intragastric balloon. Since similar weight~     loss is expected in the two groups, the study will aid in understanding the mechanisms~     behind the metabolic improvement seeing after intestine bypass.~   "
92321|NCT01848782|"~     Objective: The investigators aim to evaluate the impact of a adding a  limitations ~     section in systematic review's abstract on result's interpretation by readers Design:~     randomized controlled trial with two parallel arms. Participants will be invited to~     participate in an online survey.~      Participants: Eligible participants are corresponding authors of clinical trials published~     between 2010 and 2012 and referenced in Medline.~      Intervention: The investigators will evaluate the impact of the presence of a  limitations~      section in abstract of systematic review with meta- analysis. The investigators selected~     abstracts of meta-analysis from a sample.~      Selected abstract will be standardised and the treatment's name hidden. Two groups of~     abstract will be presented as follow: 1) abstract without  limitations  section 2)~     abstract with  limitations  section. The  limitations  section will be written by~     authors and will briefly describe the risk of bias of included studies.~      Selected participant are invited by e-mail to answer the survey. After reading one abstract~     from his/her group of randomisation they are invited to answer 5 questions about their~     interpretation of the results.~   "
92322|NCT01848769|"~     The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after~     single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and~     Formoterol pMDIs, in asthmatic children (5 to 11 years old).~   "
92323|NCT01848756|"~     Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90~   "
92326|NCT01848717|"~     The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used~     for the purpose of improving the appearance of the nasolabial fold on both sides of the~     face.~   "
92394|NCT01847794|"~     To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the~     HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.~      Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.~   "
92327|NCT01848704|"~     1Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid~     dissemination of trial results and their translation into clinical practice is particularly~     important. Abstracts published or presented in conferences are a large, rapid and free~     method to disseminate these results. However, this mode of dissemination may have serious~     consequences for patients if abstracts are not an accurate and unbiased reflection of the~     trial results. Indeed, investigators have great freedom when writing their abstracts and~     articles. They can choose the data to present and decide how to present them. Consequently,~     they have many opportunities to shape readers' impressions of their results, that is, to add~     spin (ie, spin is a specific way of reporting to convince readers that the beneficial~     effect (efficacy, safety) of the experimental treatment is higher than shown by the~     results).~      Objective: To assess the impact of spin on the interpretation of results in abstracts of~     randomized controlled trials with nonstatistically significant results in the field of~     cancer.~      Design: The investigators performed a RCT comparing the interpretation of results in~     abstracts a) with and b) without spin.~        1. Identification of abstracts of randomized trials with spin. The investigators selected~          a sample of negative published RCTs (i.e. non statistically significant results) with a~          spin in abstract conclusion identified in previous works. Inclusion criteria were 1)~          RCTs with non statistically significant primary outcome, 2) spin in the abstract~          conclusion.~        2. Abstracts' modification Selected abstracts were systematically rewritten to contain no~          spin. All abstracts were presented in the same format without the names of authors,~          references, or the name of the journal in which it was published, and the names of~          treatments were masked by using generic terms (e.g., treatment A, comparator B). All~          abstracts had the same number of words +/-20~        3. Assessment Abstracts were assessed by corresponding authors of randomized trials,~          experts of specific grants and investigator of trials registered in clinicaltrials.gov.~          Experts were invited to participate in our study. They were not informed of the~          objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or~          1 abstracts without spin.~        4. The primary endpoint was the interpretation of abstract results by the participants.~          All readers participating in the study evaluated the abstract of randomized trial and~          answered the following question: Based on this abstract, do you think treatment A would~          be beneficial to patients? (answer: numerical scale from 0-10)~   "
92328|NCT01848691|"~     People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans.~     These red blood cells breakdown faster, and this is called hemolysis. When red blood cells~     breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is~     eliminated in exhaled breath. This research study will use a device called CoSense™, which~     will measure Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how~     well the device measures the CO levels that an individual breathes out.~   "
92329|NCT01848665|"~     Increased core temperature (hyperthermia) has been associated with impaired neuromuscular~     performance; however, the mechanisms associated with these performance decrements and their~     potential synergies remain unclear. While the majority of research suggests that the~     observed fatigue is related to the central nervous system, the influence of changes in~     cerebral blood flow (CBF) and associated changes in cerebral alkalosis (estimated by~     end-tidal partial pressure of carbon dioxide; PETCO2) remains unexamined. In response to~     hyperthermia, humans hyperventilate as means of heat dissipation, resulting in a hypocapnia~     (reduced PETCO2) mediated decrease in CBF and consequently, cerebral alkalosis (increased~     cerebral pH). Previous research suggests that hyperventilation induces changes in neural~     excitability and synaptic transmission; however, it remains unclear if these changes are~     related to hypocapnia mediated decrease in CBF or decreased PETCO2 or both.~      The purpose of the proposed research program is to examine the influence of changes in CBF~     and cerebral alkalosis on neuromuscular function during passive heat stress. The research~     project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia~     (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia~     (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia~     + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each~     manipulation, neuromuscular function will be evaluated and compared to baseline~     (normothermic) conditions using a repeated measures design.~      It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will~     contribute to neuromuscular fatigue independent of changes in CBF or increases in core~     temperature.~   "
92330|NCT01848652|"~     The protocol is to assess the overall response rate (complete response and partial response)~     of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination~     with dexamethasone in immunocompetent adult patients with primary brain lymphoma large~     B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine,~     excluding strict eye lymphomas.~      This is a Phase II, open, prospective, multicenter, non-comparative with direct individual~     benefit.~   "
92331|NCT01848639|"~     This study is designed to etablish the effects of spironolactone in comparison to placebo on~     the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome,~     hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The~     primary endpoint will be the time to onset of the first incident.~   "
92332|NCT01848626|"~     The objectives of this study are:~        1. To collect data necessary for assessing the performance of advanced Vaginal Tactile~          Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;~        2. To assess the clinical suitability of the interface software to facilitate the data~          collection process and to get in vivo examination data for validation of visualization~          and analysis routines;~        3. To test the data collection technique and establish a reliable examination procedure.~   "
92333|NCT01848613|"~     Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine~     in the treatment of advanced NSCLC. A phase IV study.~      ShortTitle/ Acronym: VIVOS~      Protocol Code :IRST162.05~      Study Design: Randomized, open label cross-over study~      Study Duration: Two years~      Study Center(s): Multicenter study~      Objectives:~      Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response~     Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.~      Number of Subjects: 120~      Diagnosis and Main Inclusion Criteria:~      Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line~     chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG)~     Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2~      Study Product, Dose, Route, Regimen and duration of administration :~        -  Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine~          (60mg/m2)~        -  Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV~          vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3~          weeks. From the third cycle onwards patients will have to choose to receive oral or~          intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60~          mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice.~      Treatment will be repeated every 21 days and continued until disease progression,~     intolerable toxicity or patient refusal.~      Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days~      Statistical Methodology: The sample size is calculated based on 75% of patients preferring~     oral vinorelbine and 25% preferring intravenous vinorelbine. Therefore, the~     investigators would compare patients preferring oral vinorelbine as 75% compared to a null~     hypothesis of 50% (no difference in proportion of patients preferring oral to~     intravenous). With 80% power and a total alpha of 0.05, the estimated sample size is 60~     for group (120 total). During recruitment period, a formal interim analysis was planned when~     60 patients (30 for group) have been enrolled, with a p-value <0.0001. To claim statistical~     significance in the final analysis, the overall p-value is still 5% (referred to~     Peto-Haybittle rule).~   "
92395|NCT01847781|"~     The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13)~     in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the~     antibody response will be impaired in patients as compared with controls. In contrast, we~     postulate that the cellular immune response will be intact.~   "
92334|NCT01848600|"~     Objective: The investigators aim to evaluate the impact of a  limitations  section in~     systematic review's abstract on results' interpretation by readers.~      Design: Randomized ratio 1:1 controlled trial with two parallel arms. Participants will be~     invited to participate in an online survey.~      Participants: Eligible participants are corresponding authors of randomized controlled trial~     published between 2010 and 2012 and referenced in pubmed Intervention: The investigators~     will evaluate the impact of the presence of a  limitations  section in abstract of~     systematic review with meta-analysis. The investigators selected abstracts of meta-analysis~     published in the journal Annals of Internal Medicine between 2006 and 2011.~      Selected abstract will be standardised and the treatment's name hidden. The two groups of~     abstract will be presented as follow: 1) abstract with  limitations  section and 2)~     abstract without  limitations  section: the  limitations  section of the original~     abstract will be deleted.~      Selected participants are invited by e-mail to answer the survey. After reading one abstract~     from his group a randomization they are invited two answer 5 questions about their~     interpretation of the meta-analysis's results.~   "
92335|NCT01848587|"~     Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10%~     of women. Our hypothesis is that offering acupuncture in addition to standard care would~     reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units~     will be randomized over a 3 year period to receive standard care or standard care plus~     acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤~     4/10. Secondary outcomes will compare groups for an impairment score and for direct and~     indirect costs.~   "
92336|NCT01848574|"~     Evaluation of global understanding and with items of patients admitted to the emergency.~      Prospective observational study randomized in cluster during 6 weeks in 14 centers~   "
92337|NCT01848561|"~     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in~     patients with moderately to severely active UC who are treated as recommended in the product~     label.~   "
92338|NCT01848548|"~     Awake tracheal intubation is the standard management for patients as risk for airway~     compromise. It is also commonly done in cases where there is significant cervical spine~     pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the~     awake intubation is crucial to the patient's safety. One of the most important aspects of~     the anesthetic technique is airway anesthesia prior to placement of an endotracheal tube.~     The superior laryngeal nerve is responsible for mediating the cough reflex around the vocal~     cords. The investigators have developed an approach to reliably block the superior laryngeal~     nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local~     anesthetic into or through the thyrohyoid membrane will effectively block the superior~     laryngeal nerve~   "
92339|NCT01848535|"~     Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea~     because of their ability to stimulate beneficial bacteria. In-vitro results showed a~     promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids~     (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated~     microbiota. As the microbiota is nowadays considered as a key factor in human health, a~     further understanding of the gut microbiota functioning in-vivo is essential. This~     understanding of the use of specific prebiotics may possibly be beneficial in the prevention~     or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the~     microbiota composition and activity from healthy adults receiving amoxicillin have never~     been tested in-vivo, the investigators propose the current study as a proof of principle.~      Objective:~      To explore whether the promising effects of GOS supplementation on the composition and~     activity of gut microbiota from healthy adults as found by in-vitro, can also be observed~     in-vivo.~      Study population:~      10 healthy men and women volunteers, 18 - 40 yr old~   "
92340|NCT01848522|"~     The purpose of this study is to suggest system for improving patients' management through a~     detail analysis of physical therapy departments functioning~   "
92341|NCT01848509|"~     Objective: Set up an interoperable telemedicine system for the follow-up of patients with~     sleep apnea syndrome.~   "
92342|NCT01848496|"~     Regardless of the selected technique for dental impression, gingival displacement is an~     essential procedure specially when making impressions of subgingival finishing lines,~     because a moisture-free sulcus is a requirement for an effective impression.~      The objective of this randomized clinical study is to evaluate the efficacy of the~     conventional and cordless gingival displacement (GD) techniques.~   "
92343|NCT01848483|"~     The overall goal of this project is to implement and test the efficacy of an enhanced~     comprehensive multidisciplinary early palliative care (EPC) package that includes four~     motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the~     innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance~     care planning in a cost effective manner and could promote engagement and retention in HIV~     care. If successful, it could serve as a model of early palliative care for persons with~     AIDS in the US.~   "
92344|NCT01848470|"~     The purpose of this study is to investigate the safety and tolerability of 3 multiple and~     escalating dose regimens of CG400549 administered orally in healthy volunteers.~   "
92353|NCT01848340|"~     This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open~     label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to~     investigate the recovery, excretion, and pharmacokinetics of oral GSK1265744 in a cohort of~     6 healthy adult male subjects. Subjects will undergo a pre-study screening visit within 30~     days of the first dose and those who successfully pass pre-study assessments and meet~     eligibility criteria will be enrolled into the study to receive the equivalent of a 30 mg~     dose of GSK1265744 as an oral solution, containing approximately 70 microcuries (mcg Ci)~     [0.96 millisieverts (mSv)] of radioactivity under fasted conditions. Blood, urine and fecal~     samples will be collected for a maximum of 504 hours (21 days) following study drug~     administration. In Part B, approximately 10 healthy male and female subjects will be~     enrolled to evaluate the single-dose safety, tolerability and PK of supratherapeutic dose of~     GSK1265744 150 mg compared with placebo. Each subject will receive a single dose of~     GSK1265744 150 mg or placebo on Day 1 under fasting conditions in the morning. Blood, urine~     and fecal samples will be collected for 336 hours (14 days) following dosing.~   "
92345|NCT01848457|"~     Osteosarcoma is the most common type of bone cancer in children, adolescents and young~     adults. Treatment with surgery and a combination of three conventional chemotherapy drugs~     can cure nearly two-thirds patients with osteosarcoma, but the treatment can also cause~     irreversible damage to the kidneys and cause permanent hearing loss. The purpose of this~     study is to evaluate new approaches to prevent these side effects without interfering with~     the beneficial effects of the chemotherapy drugs on the cancer by using our knowledge of how~     the drugs damage the kidney and cochlear hair cells in the ear to selectively block these~     side effects. Preventing these side effects without interfering with the anti-cancer effect~     of the drugs will improve the outcome in survivors and may also improve the effectiveness of~     the chemotherapy regimen by preventing treatment delays and dose reductions that are often~     caused by the side effects. Patients will be carefully monitored to ensure that the new~     interventions do not adversely affect response to the treatment and do not increase the~     other side effects of the chemotherapy. Specifically, we will monitor the nutritional status~     of the patients closely and ask patients to complete a survey describing the side effects~     after each treatment cycle. We will also collect a small sample of cancer tissue at the time~     of biopsy and surgery from each patient on this study for testing to determine new classes~     of anti-cancer drugs currently under development may have a role in treating osteosarcoma.~     If effective, these new approaches to prevent kidney damage and hearing loss will be~     applicable in other types of cancers treated with the same chemotherapy drugs.~   "
92346|NCT01848444|"~     Recent international data have shown that the levels of chemical substances found in human~     milk could be at risk for breastfed infants. New data are necessary to assess this risk~     among French newborns.~   "
92347|NCT01848431|"~     The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible~     reduction of the transfusion threshold.~        -  Trial with surgical intervention~   "
92348|NCT01848418|"~     The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis~   "
92349|NCT01848392|"~     Physical activity seems to be a prognostic factor for quality of life and survival in~     patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed~     through medical examination, their daily physical activity has been little studied. Activity~     monitors have measured physical activity only in a few studies which considered mainly~     respiratory status and more recently bone mineral density and body composition. Determinants~     of physical activity in patients with CF remain largely unknown.~      The objective of this study is to measure daily physical activity with activity monitors in~     adult patients with CF and to investigate the determinants of physical activity, with a~     focus on extra-respiratory factors (nutritional status, diabetes, bone mineralization,~     anxiety and/or depression, cardiac impairment).~      Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be~     recruited in a stable period during their annual review. During this assessment, laboratory~     tests will be carried out (especially parameters for nutritional status), as well as~     measurement of body composition and bone mineral density, respiratory function tests and a 6~     minute walk test, and echocardiography. Patients will wear for 7 consecutive days a~     multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in~     metabolic equivalents (METS) and steps per day. Finally, patients will complete three~     self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression~     scale and physical activity.~      After a descriptive analysis of the study cohort, we will study qualitative and quantitative~     criteria related to physical activity (assessed quantitatively by the number of steps/day or~     metabolic equivalents).~      Linear regression models will then be developed to assess the independent factors associated~     with physical activity, adjusting for different variables of interest related to patients~     demographic, behavioral, clinical (respiratory and non-respiratory ) and biological~     parameters. Conversely, the predictive independent aspect of physical activity will be~     studied according to respiratory function, nutritional status and quality of life.~   "
92350|NCT01848379|"~     White blood cell membrane and surface structures are affected by the metabolic disorders and~     complications found in diabetes mellitus. Therefore, cellular activation, signal~     propagation, intracellular signaling as well as bactericidal effector functions are altered.~      When diabetic symptoms are corrected by the systemic intervention and treatment of the~     patients (Anti-diabetic Therapy/ADT, i.e. anti-diabetic medication, diet and dietetic~     supervision, physiotherapy and physical exercises), white blood cell functions will then~     normalize and reach the functionality comparable to those cells derived from healthy~     subjects.~      Gum diseases like periodontitis have long been associated with and termed complications of~     uncontrolled diabetes mellitus. Vice versa, after diabetic conditions are corrected,~     periodontitis treatment will be proven effective, when oral hygiene regimen, full mouth~     decontamination (FD, i.e. the oral use of topical antiseptics prior and after professional~     mechanical tooth cleaning, tooth as well as root surface planing, polishing as well as gum~     and soft tissue decontamination in combination with systemic antibiotics) are performed. To~     reinforce gum healing, reinfection prevention (RP) as well as supportive periodontal therapy~     (SPT) will be administered by dental professionals on an individual basis and a detailed~     schedule.~      If periodontal pockets critical for participant's self care are not eliminated by FD~     including RP and SPT, and niches >5mm after 6 month persist, patients are informed and~     offered surgical intervention as indicated for gum disease elimination.~      Dental follow up exams will be offered to all participants.~   "
92351|NCT01848366|"~     Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device~     and a microneedle patch electrode in patients with overactive bladder symptoms. The~     investigators hypothesize that after at least 6 weekly treatments there will be modest~     improvements in overactive bladder symptoms trending toward more improvement.~   "
92352|NCT01848353|"~     Among youth populations, American Indians have the highest prevalence of diabetes in the~     United States. This study will use exercise as the principal lifestyle modification approach~     to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has~     several excellent, but underutilized wellness facilities in their Health Services Area in~     rural Southeast Oklahoma, a low socioeconomic region. It has been established that exercise~     lowers diabetes risk, and many overweight/obese, insulin resistant American Indian youth who~     live in this region would benefit from an increase in regular exercise. The challenge is to~     modify behavior so that routine exercise is established and maintained. The proposed study~     will test whether monetary incentives can elicit greater frequency and duration of exercise~     in American Indian youth when transportation and access barriers are reduced.~   "
92366|NCT01848171|"~     Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is~     also reported increased risk for incidence of atherosclerosis and resulting coronary heart~     disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine~     replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid~     patients, especially in those with mild or moderate subclinical hypothyroidism. The present~     study was designed to investigate whether L-thyroxine replacement was effective in improving~     serum lipid profiles and retarding atherosclerosis progress.~   "
92354|NCT01848327|"~     Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple~     Sclerosis (MS). Treatment options are limited, and there is a pressing need for new~     interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to~     fuel the cells of the healthy brain. For people with neurological conditions such as MS,~     glucose is not converted into energy as efficiently as it would be in a healthy brain, which~     can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this~     problem by providing an alternative energy source that is metabolized in the liver and used~     by the brain.~      Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on~     cognitive impairment in multiple sclerosis.~      Design: Randomized, double blinded, placebo controlled trial of 158 subjects.~      Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd~     Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90~   "
92355|NCT01848314|"~     Many studies have studied the effect and safety of renal denervation. However, it remains~     unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a~     difference in renal blood flow occurs after treatment. In the light of this ignorance,~     current study will investigate whether renal denervation leads to a difference in renal~     blood flow after treatment with renal denervation.~   "
92356|NCT01848301|"~     Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second~     leading cause of late mortality after heart transplantation. CAV has been associated with a~     variety of traditional risk factors for atherosclerosis; however, immune mediated injury~     from development of de-novo donor-specific antibodies after transplantation also likely~     plays an important role. Similar to the progression of traditional atherosclerosis, it is~     likely that endothelial dysfunction is the precursor to the development of intimal~     thickening and CAV.~      The investigators hypothesize that coronary allograft vasculopathy after heart~     transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial~     dysfunction, which in turn is at least partly mediated by donor specific antibodies.~      The investigators are proposing a prospective study in humans to test the above hypothesis~     and further mechanistically understand how CAV progresses. In this study the investigators~     will test for coronary endothelial function by infusing acetylcholine into the coronary~     artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare~     findings in patients with and without donor specific antibodies.~   "
92357|NCT01848288|"~     The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics~     after phacoemulsification with the CENTURION® vision system configuration compared with the~     INFINITI® vision system configuration.~   "
92358|NCT01848275|"~     Catheter-based renal sympathetic modification has been documented to be effective option for~     blood pressure control in patients with resistant hypertension, but the safety is still~     concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at~     proximity may be enough for successful renal sympathetic modifications. This study was~     designed to compare the efficacy and safety of full length versus proximal ablation of~     bilateral renal arteries.~   "
92359|NCT01848262|"~     Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP~     And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant~     Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective~     randomized clinical trial.~   "
92360|NCT01848249|"~     Compared to chronic dialysis, kidney transplantation provides recipients with longer~     survival and better quality of life at a lower cost. In order to meet increasing demands for~     kidney allografts, kidneys from older and sicker donors are being procured. This has led to~     greater discard rates of donated kidneys as well as more complications for recipients,~     including shorter allograft survival. Available clinical models to predict kidney allograft~     quality have poor prognostic ability and do not asses the degree of kidney allograft injury.~     However, allograft injury near the time of procurement can lead to major consequences for~     the transplant recipient: greater risks of delayed graft function, poor allograft function~     and premature loss of the transplant. Our proposal is based on the hypotheses that novel~     biomarkers measured in donor urine and transport media at the time of procurement can assess~     acute and chronic kidney injury and that distinct biomarker patterns will predict allograft~     survival. In collaboration with four organ procurement organizations, we will collect urine~     samples from consecutive deceased donors and samples of transport solution for every pumped~     kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will~     determine mortality and allograft survival in all patients by linkage to the United Network~     for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed~     chart review of a subset of recipients (detailed cohort) and will also examine associations~     between biomarkers and longitudinal graft function over five years after transplant. Early,~     non-invasive and rapid assessment of donor kidney injury could drive better allocation~     decisions and potentially reduce the rates of post-transplant complications. Further, these~     new tools could provide a platform for clinical trials of therapies for allografts and~     kidney transplant recipients aimed at ameliorating allograft injury.~   "
92361|NCT01848236|"~     We would like to determine if vitamin D insufficiency exists in different ethnic groups, if~     it has an effect on bone mass and muscle function, if it has an impact on the function of~     the cells of the immune system, and if the functioning level of these systems can be~     improved by stabilizing the vitamin D levels to within normal limits.~   "
92362|NCT01848223|"~     The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish~     women and the factors affecting it.~   "
92363|NCT01848210|"~     The purpose of this study is to evaluate the efficacy and safety of the fixed-dose~     combination of coumarin and troxerutin versus placebo in the symptomatic treatment of~     chronic venous insufficiency.~   "
92364|NCT01848197|"~     RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for~     relapse and death in women with operable breast cancer.In the North American Inter-Group~     factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was~     further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard~     adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall~     survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment~     intervals (supported by the use of granulocyte-colony stimulating factor) were better than~     the conventional inconvenient weekly intervals.~   "
92365|NCT01848184|"~     The objective of this study is to assess the recurrence rate following the use of PARIETEX™~     Composite Ventral Patch in primary ventral hernia repair by open approach with~     intra‐peritoneal positioning.~   "
92367|NCT01848158|"~     The purpose of this study is to determine whether acupuncture is effective at improving~     comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the~     patients receiving acupuncture will require less medications to keep them comfortable than~     those who receive sham or fake acupuncture.~   "
92369|NCT01848132|"~     Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting~     for between 30% and 50% of the patients. Although it is considered a curable disease, still~     at least 40 % of the patients will fail first line chemotherapy. The International~     Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were~     published to identify patients with different outcome.~      There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The~     survival of these patients remains poor, with EFS around 40%.~      The combination of RCHOP with new drugs is an attractive approach to treat these patients.~      The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2~     years, with a diagnosis of DLBCL with an aIPI > 1 or an aIPI =1 with increased levels of~     beta-2-microglobulin (above the Upper Limits of Normal.)~   "
92370|NCT01848119|"~     Gabapentin has been very effective at treating pain after knee and hip operations,~     hysterectomies, and many other types of operations. A previous study at the investigators'~     hospital found that a single pre-operative dose of 600mg gabapentin produced a significant~     reduction in pain after cesarean section. However, 19% of patients complained of sedation. A~     subsequent study at the same institution looked to see if lowering the dose to 300mg would~     decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The~     results were inconclusive but it provided valuable information to guide the design of this~     study.~      The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a~     48 hour low-dose course will produce improvement in pain scores. This study will compare the~     efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and~     200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women~     undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin~     will result in decreased pain scores and increased satisfaction.~   "
92371|NCT01848106|"~     This study is designed to determine the efficacy of REG1 compared to bivalirudin in~     preventing periprocedural ischemic complications and major bleeding in patients undergoing~     PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both~     ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin~     has shown similar rates of ischemic events while demonstrating a significant reduction in~     bleeding and an improved net clinical benefit.~      Evidence from previous studies indicates that pegnivacogin represents an extremely potent,~     chemically unique anticoagulant that can be reversed by anivamersen across multiple~     populations (refer to Section 1.2.2). The question that still remains is whether Factor IX~     (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously~     studied agent while active control with anivamersen can preserve the benefit of reduced~     bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive~     study with an open-label, multi-center, active-controlled, randomized design to answer that~     question.~   "
92372|NCT01848093|"~     chronic obstructive pulmonary disease (COPD) is typically associated with mucus~     hypersecretion in the airways. In health, mucin is the major macromolecular component and is~     responsible for the protective and clearance properties of the mucus gel. In a recent study~     the investigators found that mucins are decreased and unstable in the sputum of adult cystic~     fibrosis (CF) patients.~      In this study the investigators want to investigate the differences on the mucin quantity~     and quality of airway secretions during pulmonary exacerbation of patients with COPD.~   "
92373|NCT01848080|"~     In Canada, only 10 to 15% of individuals following a cerebral vascular accident (CVA)~     receive intensive rehabilitation services. The majority of individuals return home with or~     without rehabilitation services, as outpatient services are unable to meet the demand.~     Telerehabilitation is a promising alternative approach that can help improve access to~     rehabilitation services once patients are discharged home. The main hypothesis is: The~     participants who received the intervention via telerehabilitation will have a gain in their~     Community Balance and Mobility Scale (CB&M) score that will not be inferior to the gain~     observed in participants who received the intervention via home visits (less than 4 points).~     The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation~     approach compared to home visits. The secondary hypotheses are: Two to four months following~     discharge from hospital, the investigators hypothesize that the level of: 1) gain in~     physical and psychological capacities related to mobility; 2) gain in the quality of life,~     and 3) satisfaction of services received will not be inferior in the TELE group compared to~     the VISIT group and that 4) the Tele approach will be more cost-effective compared to the~     VISIT approach. The platform used will be based on a technological infrastructure that was~     developed and tested in previous telerehabilitation studies. The study is a randomized~     control trial (RCT).The study population of interest will target individuals who have had a~     stroke who stayed in a hospital. Participants will be recruited during the hospitalization~     period at each of the three sites. The investigators expect to recruit 240 participants, 120~     per group. All evaluations will be completed in the research centers/hospitals of the three~     sites and will last approximately 1.5 hours. The first evaluation will be conducted prior to~     hospital discharge (T1) to establish the baseline measures. The two other evaluations will~     be conducted 2 months (T2) and four months (T3) following discharge from hospital. The~     independent variable is individualized exercise program, based on Tai Chi. The dependant~     variables are Balance, functional mobility, physical capacities, psychological capacities~     related to mobility and balance, quality of life, satisfaction with care received, cost of~     services according to the healthcare system. The difference between the two groups will then~     be compared using a t-test. The economic analysis will be a type of cost-effectiveness.~   "
92374|NCT01848067|"~     This phase I/II trial studies the side effects and best dose of alisertib when given~     together with abiraterone acetate and prednisone and to see how well it works in treating~     patients with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens~     can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also~     lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as~     prednisone, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Giving alisertib, abiraterone acetate, and~     prednisone together may be an effective treatment for prostate cancer.~   "
92375|NCT01848054|"~     The purpose of the study was to assess the efficacy of induction treatment with~     buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with~     buprenorphine only. The hypothesis is that starting directly on OX219 works equally well~     (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on~     Day 3.~   "
92376|NCT01848041|"~     This is an exploratory, proof of concept study to evaluate the safety and efficacy of~     RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in~     patients with ptosis.~   "
92396|NCT01847768|"~     In this study, the following subjects will be exposed to human rhinovirus (HRV):~        -  those with classification of mild-moderate asthma~        -  healthy control subjects.~      The investigators will study the kinetics of HRV-induced inflammatory and remodeling~     responses in a well characterized group of asthmatic subjects and compare these outcomes to~     those in a healthy, non-asthmatic control group.~   "
92377|NCT01848028|"~     Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely~     confined to systemic therapy in Germany. Systemic therapy includes conventional systemic~     therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g.~     adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments~     has been shown in clinical studies (and is incorporated in international guidelines),~     knowledge about long-term outcomes, optimal treatment and effectiveness under real-world~     conditions is still missing. PsoBest, the German registry on the treatment of moderate to~     severe Pso and PsA started in 2008 and documents the long-term course of patients being~     administered any biologic or conventional systemic antipsoriatic drug authorized in Germany~     for the first time. The registry evaluates the long-term course of 3,500 patients with Pso~     and PsA treated with systemic antipsoriatics.~   "
92378|NCT01848015|"~     To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced~     gastric cancer after radical resection.~      To identify the relationship between the detection of circulation tumor cells and recurrence~     patterns of gastric cancer after radical resection.~   "
92379|NCT01848002|"~     This trial was conducted in Europe. The aim of this trial was to investigate safety and~     pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in~     healthy volunteers.~   "
92380|NCT01847989|"~     This trial was conducted in Europe. The aim of this trial was to investigate safety and~     pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII,~     rFXIII) in healthy volunteers.~   "
92381|NCT01847976|"~     The purpose of this study is to see if women with bone metastases from breast cancer will~     benefit from the addition of doxycycline to their standard bone-targeted therapy.~     Participants will be asked to take 100 mg of Doxycycline orally twice a day for 12 weeks.~     Blood and tissue collection will further define the mechanism of the benefits if there are~     any.~   "
92382|NCT01847963|"~     This study is a non randomized non comparative study with two Siddha formulations~     Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts~     existing for longer period. But there is no scientific data is documented about these~     formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis.~     After the preliminary drug standardization the clinical study is Started at The National~     Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones~     or Changes in the number and size of the stones with 45 days drug treatment.~   "
92383|NCT01847950|"~     The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the~     frequency and constistency of stools in subjects with functional constipation~   "
92384|NCT01847937|"~     This project aims to develop high field MR techniques to detect nerve lesions in diabetic~     patients. The MRI findings will be compared to results from conventional evaluations and~     nerve conduction studies to determine the validity as part of a clinical practice.~   "
92385|NCT01847924|"~     Patients who have suffered from stroke may develop problems with thinking. Moreover, such~     patients have a high risk of becoming demented, more dependent or dying. Therefore, further~     studies are urgently needed to find effective and safe treatments.~      Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain~     cells and connections in animals. Neuroaid may improve blood flow in the brain and~     functional recovery after stroke in patients. Neuroaid-II is a simplified formula with only~     the main 9 herbal ingredients of the original formula and no animal ingredients.~      The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot~     double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is~     a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after~     stroke. The study aims to investigate the effectiveness of the study drug in improving~     cognitive performance. The safety of the study drug will be closely monitored using adverse~     events, laboratory tests and vital signs.~      The trial is important as it aims to set new standards for the scientific evaluation of~     Asian Traditional Medicine for integration into standard medicine practice. It may~     potentially establish a novel therapeutic approach for improving cognition after stroke.~   "
92386|NCT01847911|"~     The effect of a self directed video strategy will be compared to a face to face neonatal~     resuscitation training program. The hypothesis is that both strategies are equivalent.~   "
92387|NCT01847898|"~     This is a randomized, controlled study to document and evaluate the clinical performance of~     the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and~     lumbar spine.~      The randomized, controlled trial (RCT) will compare patients with VBS and Balloon~     Kyphoplasty.~   "
92388|NCT01847885|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) reduces post-stroke shoulder pain. This study involves a device called the~     Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles~     in the shoulder. The Smartpatch System includes a small wire (called a Lead) that is~     placed through the skin into the muscle of the shoulder. It also includes a device worn on~     the body that delivers stimulation (called the Smartpatch Stimulator).~   "
92389|NCT01847872|"~     The overall goal of this study is to identify interference between intramuscular Inactivated~     Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at~     nine months of age and to confirm the safety of co-administration. In addition, the study~     will compare the immunogenicity and safety of IPV when administered via different routes.~      A total of 1504 healthy infants between the ages of nine to ten months, who have completed~     their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine~     (tOPV) will be recruited for this study.~   "
92390|NCT01847859|"~     The investigators aim to study the feasibility and reliability of pocket-size diagnostic~     ultrasound examinations performed by nurses of postoperative patients who have underwent~     cardiothoracic surgery in a cardiac unit.~   "
92391|NCT01847833|"~     The goals of this study are to:~        1. To improve upon and develop new innovative magnetic resonance imaging techniques that~          refine image quality and enhance performance. Improvements in these areas will have~          positive implications for medical diagnosis and treatment.~        2. To correlate MRI images with underlying disease pathophysiology in order to ensure that~          imaging accurately reflects the disease process.~   "
92392|NCT01847820|"~     To show that having less qualified personnel (non-Laboratory trained professionals) perform~     the test yields the same result as if a Laboratory trained professional performed the test.~   "
92397|NCT01847755|"~     This study is designed to test the hypothesis that patients with Traumatic Brain Injury~     (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood~     flow as evidenced by single-photon emission computerized tomography (SPECT) scan.~     Improvement is evidenced by increase in number of pixels on SPECT Scan and increased brain~     metabolism. Improvement may also be identified via cognitive assessments administered by~     Jupiter Medical Center Research Department.~   "
92398|NCT01847742|"~     To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat~     the trauma symptoms among Syrian Refugees.~   "
92399|NCT01847729|"~     The aim of this study is to determine the current prevalence of co-addictions, including~     problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST),~     and to then compare patients receiving OST with or without a co-addiction (excluding tobacco~     dependence) in order to determine their clinical profile.~      In addition, an ancillary study to be carried out only among those patients receiving~     methadone, will aim to etablish whether a low plasma concentration of methadone, on the one~     hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics~     most commonly associated with the presence of co-addictions. This will allow us to complete~     patient's pharmacological characterization.~   "
92400|NCT01847716|"~     Pulmonary arterial hypertension (PAH) is a disease that causes raised blood pressure in~     blood vessels that pick up oxygen from the lungs. It has a life expectancy similar to some~     cancers. There is treatment available but there is no cure. We now know that PAH is~     associated with weakness in the muscles in the legs, which contributes to the symptoms~     patients' experience. Researchers believe that certain proteins found in high levels in the~     blood of patients with other chronic diseases can affect muscle function and growth. One of~     these proteins is called growth differentiating factor (GDF) 8, high levels of which are~     associated with muscle weakness in chronic obstructive pulmonary disease(COPD) and heart~     failure (HF). Interestingly there are drugs available which block the actions of GDF-8 on~     muscle cells which has been shown in animals to result in increased muscle size. A related~     protein called GDF-15 is found in elevated levels in patients PAH, and is linked to~     prognosis. Our preliminary data suggests that GDF-15 can also directly influence muscle size~     in a number of situations. We aim to investigate the role of GDF-15 and related molecules in~     the development of muscle weakness in patients with PAH. We will do this by measuring~     certain markers of muscle weakness and taking blood and muscle samples in patients and~     controls. We will then compare the levels of GDF-15 in these tissues in those with and~     without muscle wasting. We hope this work will lead to a greater understanding of the role~     of GDF-15 in the development of muscle weakness in patients with PAH. GDF-15 levels may be~     important in allowing us to define which patients have muscle weakness. In the future we aim~     to perform a clinical trial of drugs which block the actions of GDF-15.~   "
92401|NCT01847703|"~     This study is intended to explore differences in oncologic and surgical safety between~     robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial~     cancer.~   "
92402|NCT01847690|"~     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency-~     Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and~     long-term complications. Many patients take stress-doses that are extra doses of~     hydrocortisone or cortisone acetate before or during stressful physical or psychological~     events. However, the effect of such dosing has not been tested in scientific studies. In~     this double blind cross-over designed pilot trial we aim to test the effect of an extra dose~     of cortisol on physical activity and hormone levels.~   "
92403|NCT01847677|"~     Recently results have shown that Bevacizumab is active both in monotherapy and in~     combination therapy in patients with ovarian cancer. One of our objectives is to evaluate~     whether the addition of neoadjuvant bevacizumab improves the response and whether this~     affects the evolution of patients.~   "
92404|NCT01847664|"~     The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs.~     Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated~     diverticulitis.~   "
92405|NCT01847651|"~     Patients with cirrhosis of the liver may suffer from a condition called hepatic~     encephalopathy which in its mildest form as mental slowing and impaired reaction times in~     driving and machinery operation. Left untreated it may lead to deep coma. The cause is not~     fully understood but is though to be related to the inability of a damaged liver to filter~     out toxins such as ammonia in the blood, which then accumulate within the brain and result~     in altered function and swelling within certain brain cells,astrocytes. These patients also~     suffer from muscle loss, which is associated with a poor outcome. L-ornithine~     L-aspartate(LOLA) is a licensed drug in Germany and has been shown to promote ammonia~     elimination from the body in the form of urea. Some experimental studies have suggested that~     LOLA also potentially attenuates muscle loss by incorporating ammonia into muscle in the~     form of glutamine. The aim of this study is to determine cognitive and nutritional effects~     of 12 weeks of LOLA administration and its effect on brain muscle structure and function in~     patients with cirrhosis.~   "
92406|NCT01847638|"~     To investigate inflammation, visual acuity and macular thickness after treatment with~     Prolensa vs Ilevro after cataract surgery.~   "
92407|NCT01847625|"~     The study will evaluate (in-vitro) the forces that are typically used for the extraction of~     pacemaker or defibrillator electrodes.~   "
92408|NCT01847612|"~     The aim of the present study is to evaluate whether the use of indocyanine green fluorescent~     cholangiography is responsible in a decrease of biliary fistula's rate in patients with~     liver diseases requiring liver resection.~   "
92409|NCT01847599|"~     The purpose of this study is to evaluate the efficacy of the implementation of an~     educational program on adherence to capecitabine alone or in combination to lapatinib.~   "
92410|NCT01847586|"~     The purpose of this study is to determine if a novel brain stimulation approach using~     magnetic stimulation (Transcranial Magnetic Stimulation [TMS]) can improve memory and~     thinking processes in individuals with mild Alzheimer's disease (AD).~   "
92457|NCT01846975|"~     RA (rheumatoid arthritis) patients effectively treated weekly with SC (subcutaneous)~     Abatacept will be switched to IV (intravenous) Abatacept and restarted with SC Abatacept~     four after IV application. The investigators hypothesize that a switch from SC- to~     IV-abatacept and back in patients with low disease activity is safe and not associated with~     a worsening of the disease.~   "
92411|NCT01847573|"~     The main purpose of this study is to test the safety and tolerability of different,~     increasing doses of an experimental medication called HT-100 in boys and young men with~     Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help~     promote healthy muscle regeneration, diminish inflammation and the resulting damage to~     muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this~     study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream~     will also be taken.~   "
92412|NCT01847560|"~     This study plans to describe utilization patterns for oral anticoagulants over time in~     patients with non-valvular atrial fibrillation at risk for stroke using electronic claims~     data from a United States commercial insurance database.~   "
92413|NCT01847547|"~     This cohort study plans to identify initiators of oral anticoagulants using electronic~     claims data from a commercial insurance database to quantify associations between~     anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in~     patients with non-valvular atrial fibrillation at risk for stroke.~   "
92414|NCT01847534|"~     One of the essential treatments for assisting patients in their recovery from illness is the~     provision of nutrition in a liquid form which is delivered into the stomach or as a fluid~     into the vein. Until recently the benefits of nutrition were undervalued in the critically~     ill, however, it has now become clear that targeted nutrition can positively affect a~     person's outcome. This is particularly important for patients who are significantly unwell~     and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy~     leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly~     contributes to their poor recovery.~      Whilst nutrition is essential for recovery, there are several issues with the delivery of~     nutrition via the stomach (the most commonly used method of delivering nutrition in the~     critically ill). For many reasons, patients are unable to tolerate large quantities of~     nutrition via the stomach and in addition to this there are hospital or procedural reasons~     for nutrition being turned off for lengthy periods of time. As such, this results in~     patients being delivered only about half of the nutrition that is planned. One potential way~     to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach~     continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the~     stomach.~      In this study of 100 patients, we will deliver combined nutrition via the vein and stomach~     in 50 patients and the other 50 patients will receive nutrition as per normal practice. We~     will measure important outcomes for these patients to determine if this allows us to meet~     significantly more of their nutrition needs. This study will also help us determine how best~     to design a larger study of this strategy.~   "
92415|NCT01847521|"~     Background. Increasing evidence indicates that brain inflammation is important in the~     pathogenesis of neuropsychiatric disorders, including at least a significant proportion of~     subjects with Autism spectrum disorder (ASD). Natural flavonoids, such as luteolin and~     quercetin, exhibit potent antioxidant and anti-inflammatory activities, inhibit the release~     of inflammatory mediators from human mast cells, and reduce maternal interleukin 6-induced~     autism-like behavioral deficits related to social interactions in mice. In a case series of~     37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4~     months reported gains in eye contact, attention and social interaction according to parental~     reports.~      Aim. The purpose of this study was to assess the effectiveness and tolerability in white~     children with ASD of a dietary supplement containing 2 flavonoids, luteolin and quercetin,~     and the quercetin glycoside rutin.~      Methods. Fifty children (42 boys and 8 girls) divided into 2 equal age groups (4-6 years~     old, and 7-10 years) with ASD were enrolled in a 26-week, prospective, open-label trial at~     the 2nd University Department of Psychiatry at Attikon General Hospital, Athens, Greece,~     the Ethics Committee of which approved the study. The parents of all subjects were informed~     of the study's aims, including risks versus benefits of participating and not participating~     as well as the inclusion and exclusion criteria, and they written consent for participation~     in the study.~      Participants had already been diagnosed with ASD based on clinical assessments, and this~     diagnosis was corroborated at the 'Attikon' clinic by meeting the cutoff scores on both the~     DSM-IV-TR, symptom list and the ADOS algorithm. All children were medication naive. Apart~     from the diagnostic evaluation, the assessment also included a thorough medical evaluation~     comprising a physical examination and health history (including a review of allergic and~     gastrointestinal symptoms, as well as any food allergies or food intolerance). All~     concurrent interventions were thoroughly noted (type and hours), and the same was done at~     all visits. After meeting screening criteria, subjects were evaluated at the baseline visit,~     mid-trial visit at 18 weeks, and final visit at 26 weeks.~      Children were administered a dietary formulation containing 2 flavonoids, luteolin (100~     mg/capsule) and quercetin (70 mg/capsule), and the quercetin glycoside rutin (30~     mg/capsule). The dose used was 1 softgel capsule per 10 kg (22 lb) weight per day with food~     for 26 weeks.~      The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland~     Adaptive Behavior Scales (VABS), communication, daily living skills, and socialization. The~     VABS was chosen because the impact of an agent on adaptive functioning in real life is even~     more important for obtaining a better quality of life than just alleviation of some~     symptoms. The raw scores from the interview can be also expressed as an age-equivalent score~     and a standard score compared with those of the subject's peers. There are also~     supplementary special norms for individuals with autism. Although standard scores could be~     more useful in subject characterization, their use as an outcome measure has been proven to~     be less sensitive due to floor effects and reduced variability, especially in short time~     periods, and thus these scores underestimate change. Conversely, scores of special norms~     tend to overestimate change, as a small increase in a raw score can produce a big~     improvement in special norm percentile rank. Thus, raw scores and age-equivalent scores seem~     to be the most appropriate for use as outcome measures, with the latter being more easily~     interpreted as change over time.~      Secondary outcomes included the Aberrant Behavior Checklist (ABC), the Autism Treatment~     Evaluation Checklist (ATEC), and the Clinical Global Impression-Improvement score (CGI-I).~     To explore other possible effects of the formulation not captured from the aforementioned~     instruments, we chose to record any other benefits observed and reported by the parents~     during its use. For this, the primary clinician (K.F.) conducted telephone or in-person~     interviews of the parents, independently of the assessing clinician (A.T.), to discuss the~     possible gains of the child. CGI-I was also independently coded by the primary clinician~     with personal assessments as well as with information gathered by parents and, in the~     majority of cases, by the subjects' trainers.~      Compliance was monitored by softgel capsule count and the parents' assurance that the~     capsules had actually been taken at each visit; in case of a capsule count <85% of the~     prescribed dosage at midterm and at the end of the study, the subject was excluded from the~     final analysis.~      Adverse events were systematically recorded on an adverse event form by using scales~     indicating severity, relationship to the study procedures, action taken, and any therapy~     required.~   "
92416|NCT01847508|"~     The primary objective is to compare the mechanical failure risks in the first year after~     treatment.~   "
92417|NCT01847495|"~     The purpose of this study is to determine the effects of CyberKnife stereotactic body~     radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal~     cancer that has spread to the liver.~      Conventional radiation therapy has a limited role in the treatment of patients with liver~     metastases because the radiation doses are limited by liver toxicity. The CyberKnife system~     is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so~     that injury from radiation to the nearby normal tissue will be minimal. It is approved by~     the U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in~     the body when radiation therapy is required. While the device is no longer classified as~     investigational, the best treatment dose and times are still being evaluated.~      Chemotherapy delivered with radiation therapy can increase the effectiveness of treatment,~     and may allow for a lower dose of radiation therapy to be utilized, thereby limiting~     negative side effects.~      In this study, patients will receive Cyberknife radiosurgery directed to liver metastasis~     for 3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered~     intravenously daily for 3-5 days (5 treatments within 10 elapsed days), and prior to~     radiation therapy. Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30,~     36, and every 6 months thereafter for 3 years.~   "
92418|NCT01847482|"~     A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic~     hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac~     arrest, post-return of spontaneous circulation (ROSC) patients in Japan.~      The objective of this study is to verify that therapeutic hypothermia performed by~     intravascular cooling using the investigational device (IVTM) can control body temperature~     appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.~   "
92419|NCT01847469|"~     This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress~     disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive~     either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization~     will be done using 3:1 ratio and will be performed by our research pharmacy using a random~     assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.~     Medication will be titrated over a 6 week titration phase followed by a 6 week treatment~     phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will~     be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.~     Veterans will be recruited primarily through advertisement, but also through the clinical~     facilities at the VA and from other collaborators.~   "
92420|NCT01847456|"~     The researchers will investigate if brain insulin action influences peripheral insulin~     sensitivity in healthy humans.~   "
92421|NCT01847443|"~     The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess~     the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the~     reference nicotine gums (2 mg and 4 mg) in healthy smokers.~   "
92422|NCT01847430|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The~     study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these~     subjects.~   "
92972|NCT01840254|"~     The aim of this study is to test the hypothesis that addition of dexmedetomidine to~     fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of~     fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients~     undergoing lumbar spine surgery.~   "
92423|NCT01847417|"~     An open label, balanced, randomized, three-treatment, three-period, six-sequence,~     cross-over, single dose, comparative bioavailability pilot study under fed conditions. For~     fed condition, after check-in, subjects will receive a standard dinner consisting (1000 -~     1200 calories) after which they will be required to fast overnight (for at least 10 hours).~     Thereafter they will receive a non-vegetarian high calorie, high-fat breakfast (800-1000~     calories) before dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and~     dinner.~   "
92424|NCT01847404|"~     An open label, balanced, randomized, three-treatment, three-period, six-sequence,~     cross-over, single dose, comparative bioavailability pilot study under fasting conditions.~     The treatments will be administered after an overnight fasting of at least 10 hours in each~     period. Fasting will continue for four hours post-dose, and then meals will be provided at~     specified intervals. Drinking water will not be permitted one hour before dosing and until~     one hour post-dose.~   "
92425|NCT01847391|"~     This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose~     study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy~     subjects.~   "
92426|NCT01847378|"~     Ventricular tachycardia is one of the commonest cause of sudden death in chronic chagas~     disease. As most ventricular tachycardias originate from scar in patients with heart~     disease, catheter ablation is an important step in patient treatment. Identification of~     fibrosis prior to ablation of sustained ventricular tachycardia (SVT) might reduce the time~     of anesthesia, procedure time, radiation exposure and possibly the risk of complications.~     Knowledge of arrhythmia circuit within scar allows planning strategies for each procedure.~     Condreanu et al. stablished that voltages inferior to 6.52 mV (unipolar) and 1.54mV~     (bipolar) are useful tools in detecting scar during electroanatomic mapping. Accuracy,~     however when compared to magnetic resonance imaging is limited due to difficulties in~     maintaining good contact between ablation catheter and ventricular wall. Contact force~     catheters might help increase accuracy of voltage mapping because they allow detection of~     poor contact areas. Although the threshold for identification of scar in ischemic and non~     ischemic patients during electroanatomical mapping is already known, this parameters still~     lacking for chronic chagasic individuals. A marked qualitative histological difference~     between these fibrous scars supports the hypothesis that voltage scar in chagasics might be~     different. Catheter ablation contact with endo and epicardial surface is an important issue~     when ablating arrhythmias. Conventional catheter ablation is not equipped with sensors~     capable of detecting degree of contact with the target. To our knowledge, the literature~     lacks information in regard to late lesions produced by a known contact force pressure in~     vivo. The pattern of electrical activation in these patients and their relationship with~     local coronary veins for resynchronization likely to approach through the coronary sinus can~     be useful in defining chagasic that can benefit from resynchronization.~        1. Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on~          3T MRI~        2. Correlate areas of late activation within scar during activating mapping in sinus~          rhythm with different signal intensity in 3T MRI~        3. Evaluate the influence of contact pressure during application of radiofrequency in~          making fibrosis analyzed 30 days after the procedure using a 3T MRI.~        4. Assess the site of latest left ventricular activation in sinus rhythm and correlate~          with the coronary veins location~   "
92427|NCT01847365|"~     Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often~     leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no~     established therapy for treating or delaying its progression.~      Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic~     option for RP. Research has shown that TES improves retinal cell viability and visual~     function. An initial pilot study of TES on 24 participants with RP demonstrated that it was~     safe and improved vision.~      This study aims to confirm the safety of the new CE-approved Okustim device and to further~     characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1~     year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye~     Hospital.~      Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6~     months. This will be followed by a further 6 months of observation without stimulation~     giving a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12~     months after their initial baseline visit by clinical examination, investigations and~     questionnaires.~      Participants should have a diagnosis of RP and be capable of giving consent. Participants,~     or a carer, should have sufficient motor skills to attach the device themselves. As this~     study seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g.~     diabetic retinopathy) cannot be included in the study.~   "
92428|NCT01847352|"~     On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic~     blood pressure (PASP, blood pressure through the lungs) to increase. We have previously~     shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise~     and that lowering iron by giving a drug that binds iron, magnifies this response. This is~     potentially a clinically important observation since iron-deficient people may be at~     increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia~     due to lung disease or residence at high altitude; furthermore if this were true then~     intravenous iron could be an important treatment in this patient group in the event of~     hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels~     affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by~     inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia~     inducible factor' or HIF. This includes one of the body's normal responses to low oxygen~     levels - raising blood pressure through the lungs.~      This study will answer the question (1) do iron-deficient volunteers have a greater rise in~     PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron~     cause a greater reduction in the rise in PASP in those who are iron-deficient than~     iron-replete? The purpose of this study is not to test the safety or clinical efficacy of~     iron which is already known.~   "
92429|NCT01847339|"~     The effective relief of pain is of paramount importance to anyone treating patients~     undergoing surgery. Post-operative pain increases the possibility of post-surgical~     complications, raises the cost of medical care, and most importantly, interferes with~     recovery and return to normal activities of daily living. Therefore pain control is~     essential in the management of patients undergoing spinal surgery.Parenteral administration~     of narcotics has been the mainstay for postoperative pain relief in patients undergoing~     laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of~     pain control in several major surgical interventions including spinal surgery. However, some~     of the side effects have limited their widespread use (eg, late-onset respiratory~     depression). Therefore, alternative measures of pain control including infiltration of~     paraspinal musculature with local anesthetics have been investigated with conflicting~     results. In situations such as laminectomies, where the epidural space is exposed as part of~     the surgical procedure, the application of absorbable gelatin sponge soaked in local~     anesthetics appears to be an alternative for providing postoperative analgesia. By~     investigating the probable analgesic effects of this method the investigators may relieve~     post laminectomy pain with minimal side effects and also costs.~   "
92430|NCT01847326|"~     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized~     nanoparticle formulation when given together with carboplatin followed by chemoradiation in~     treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as~     paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and~     hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by~     chemoradiation therapy may be an effective treatment for head and neck cancer.~   "
92431|NCT01847313|"~     Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst~     form, can lead to early cardiovascular death or kidney failure. A group of medicines used to~     treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people~     with diabetes from DKD by reducing inflammation in the kidney. This study aims to test this~     theory by studying the effect of GLP-1 on kidney function in people with diabetes.~      To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1~     treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney~     function using blood and urine tests. The investigators will compare these results to~     patients with DKD who do not receive GLP-1 treatment.~      If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then~     it could be developed as a viable new treatment for people with DKD, and may significantly~     reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a~     major advance in the treatment of DKD.~   "
92432|NCT01847300|"~     The goal of this project is to test the efficacy of a computer-facilitated Screening and~     Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among~     18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and~     hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use.~     Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those~     receiving cSBI-M will have lower rates of any alcohol use at follow-ups compared to TAU. 2)~     Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction~     intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative~     history of past-12-months drinking at baseline), those receiving cSBI-M will have lower~     rates of drinking initiation and heavy episodic drinking (HED, a.k.a. binge drinking). (b)~     Among 18- to 25-yr-old drinking USN/USMCs, those receiving cSBI-M will have higher rates of~     drinking cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED,~     and driving after drinking or riding with a drinking driver.(3) Test the effects of cSBI-M~     on tobacco use; explore its effects on other drug use. (4) Assess potential moderators~     (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance~     use), mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol~     and drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old~     patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any~     alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2)~     higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking~     and driving after drinking or riding with a driver who has been drinking.~   "
92433|NCT01847287|"~     The primary aim of this study is to evaluate the effect of using Tysabri on changes in the~     brain using MRI and on disease progression in patients with relapsing-remitting Multiple~     Sclerosis over 5 years.~   "
92434|NCT01847274|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of~     niraparib as maintenance in platinum sensitive ovarian cancer patients who have either~     gBRCAmut or a tumor with high-grade serous histology and who have responded to their most~     recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP~     inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily~     continuously during a 28-day cycle. Health-related quality of life will be measured by the~     Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of~     Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability~     will be assessed by clinical review of adverse events (AEs), physical examinations,~     electrocardiograms (ECGs), and safety laboratory values.~      The primary objective of this study is to evaluate efficacy of niraparib as maintenance~     therapy in patients who have platinum sensitive ovarian cancer as assessed by the~     prolongation of progression free survival (PFS).~   "
92435|NCT01847261|"~     During aging there is a tendency for muscle protein synthesis (growth) to become less~     efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can~     affect strength and mobility. Protein consumption may be one opportunity to alleviate this~     problem especially when consumed in appropriate amounts following resistance training. This~     study is designed to determine if a soy dairy protein blend, shown to be effective in~     younger adults, will produce beneficial muscle protein synthesis in older healthy adults~     following resistance exercise.~   "
92436|NCT01847248|"~     -  Molecules indicating endothelial injury may serve as biomarkers for severe sepsis~          because of the critical role of endothelial injury in organ dysfunction during severe~          sepsis.~        -  HSPA12B is primarily located in endothelial cells and detectable during sepsis.~        -  The investigators speculated that HSPA12B from endothelial cells might be correlated~          with severe sepsis.~   "
92437|NCT01847235|"~     The purpose of this study is to determine the efficacy and safety of temozolomide in patient~     with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.~   "
92438|NCT01847222|"~     Safety assessment of SANGUINATE™ in Healthy Volunteers.~   "
92439|NCT01847209|"~     This is a phase II protocol to determine the safety and feasibility of Intraoperative CT~     fluoroscopy guidance for lung resection for small nodules.~   "
92440|NCT01847196|"~     The primary objective of this clinical trial is to obtain initial insights into the safety~     of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism~     (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.~   "
92468|NCT01846819|"~     100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a~     comprehensive clinical evaluation for severity of liver disease, anemia, depression, and~     fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the~     6-minute walk test (6MWT), a standardized exercise test that measures the distance that a~     patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using~     three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and~     the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to~     select the factors that potentially are associated with the scores as indicated by a P value~     <.20; the selected factors will then be entered in a stepwise regression to create a~     multivariate model giving the combination of factors that are significantly associated with~     the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the~     model in order to test its significance while controlling for the other factors.~   "
92441|NCT01847183|"~     The purpose of this research is to create and evaluate the efficacy of an exciting (fun to~     use), and potentially disseminable computer-based prevention program, Click City®: Alcohol,~     for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click~     City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high~     school. Secondary goals of the program include decreasing students' intentions and~     willingness to engage in heavy drinking in high school. The proposed program is unique both~     in its delivery system and the development process.~      Aim 1: The investigators plan to develop and test approximately 24 components over the first~     two years of the study.~      Aim 2: The final Click City®: Alcohol program will consist of 12 effective components~     delivered in six sessions over a three-week period in 7th grade. This is followed by two~     booster sessions, consisting of a total of 5 components delivered over a one-week period in~     8th grade. Educational newsletters to parents and teacher guides will accompany the program.~      Aim 3: Following development, the investigators will conduct a group randomized trial to~     evaluate the efficacy of this program as compared to schools' usual alcohol prevention~     curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle~     schools to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC).~     Students in the Click City®: Alcohol and yoked UC schools will be assessed prior to the~     beginning of the 7th grade program, following the 7th grade program, following the 8th grade~     booster, which would occur approximately one year after the 7th grade program, and a~     follow-up assessment in the 9th grade to assess long-term outcomes, one year after the 8th~     grade assessment.~   "
92442|NCT01847170|"~     The human immune system is usually tolerant of the millions of beneficial commensal bacteria~     (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with~     Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal~     bacteria, which initiates abnormal immune responses in susceptible individuals. The~     resulting inflammation that occurs in the gastrointestinal tract damages the intestinal~     lining, leading to symptoms (such as intractable diarrhea, pain or weight loss), heightened~     cancer risk, other serious complications with substantial morbidity and even death. Current~     therapies for IBD focus on suppressing the excessive immune response to these bacteria, but~     have major side effects and do not address any role of the microbiome in disease~     development.~      The investigators hypothesize that there is heightened intraluminal generation of~     pro-inflammatory factors by luminal pathogenic bacteria, such as extracellular nucleotides~     and purinergic derivatives, which trigger host immune cells. This results in loss of~     suppressive T regulatory cells with unrestrained immune cell deviation to pathogenic T~     helper cells that cause inflammatory responses. The investigators' proposal is that~     correcting the disease-provoking microbiome would beneficially improve gut microbial~     diversity, alter immune responses elicited in patients by such microbial products of~     pathogenic bacteria, and ultimately limit and suppress disease activity.~      To test the hypothesis, the investigators propose to enroll patients with active Crohn's~     Disease, and introduce the microbiome of healthy and unrelated individuals to patient's~     intestinal tract, via fecal biotherapy (FBT) with all applicable safety measures. The~     investigators propose to comprehensively test the effects of FBT on the host microbiome,~     determine microbial production of inflammatory nucleotides and derivatives, which the~     investigators suggest might impact the host immune response and disease activity in patients~     with IBD.~   "
92443|NCT01847157|"~     Background and purpose:~      About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor~     impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke~     patients' daily living independence and quality of life. However, treatment effect of~     current interventions is still limited. Nick Ward and Leonardo Cohen suggested 5~     intervention strategies for stroke motor recovery: （1） reduction of somatosensory input from~     the intact; （2） increase in somatosensory input from the paretic; （3） anesthesia of a body~     part proximal to the paretic hand; （4） activity within the affected motor cortex may be~     up-regulated; （5） activity within the intact motor cortex may be down-regulated. Recent~     studies have shown each strategy to be effective in stroke patients with mild or moderate UE~     impairment. However, evidence for people with severe UE impairment after stroke remains~     unclear. Since research has found a greater effect for combined strategies than a single~     strategy, this proposal develops a combined intervention with the above 5 strategies, named~     transcranial direct current stimulation （tDCS） combined sensory modulation intervention.~     This intervention is expected to be most effective for people with severe UE impairment~     after stroke.~      In addition, neuroimaging can provide in vivo information about the brain plasticity which~     underpinning the motor recovery after stroke. However, image indexes that can be used in~     stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3~     aims: （1） to examine the treatment effect of the tDCS combined sensory modulation~     intervention in stroke patients with severe UE impairment; （2） to examine the underline~     mechanism of the efficacy of tDCS combined sensory modulation intervention using~     neuroimaging technology.~      Methods:~      This study is a double-blinded randomized controlled trial which will recruit 60 people who~     have had stroke onset more than 6 months and have severe UE motor impairment. All~     participants will be randomly assigned into 2 groups. The experimental group will be given~     the tDCS combined sensory modulation intervention, combining bilateral tDCS stimulation,~     anesthesia techniques and repetitive passive motor training. The control group is given sham~     tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated~     for outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months~     post-intervention）. The immediate and long-term effect of the interventions will be~     examined.~      Primary outcome indicators include upper extremity impairment measures. Secondary outcome~     measures include upper extremity function, activities of daily living function, functional~     Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using~     diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times~     （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.~      Anticipatory results and contributions:~      The results of the studies are expected to present a potentially effective intervention for~     stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this~     particular intervention is also provided. The results will contribute to our understanding~     of brain plasticity for UE motor recovery after stroke. Findings from this proposal may help~     researchers and clinicians choose or develop interventions that are optimal to their clients~     individually.~   "
92444|NCT01847144|"~     Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have~     little effect in one person but a large effect in another. Understanding mechanisms of~     altered response to treatment could aid treatment selection and assist the design of new~     medications with lower nonresponse rates.~      This study will examine the physiological mechanisms and potential clinical/biomarker~     predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering~     medication and answer fundamental methodological questions for the future study of variation~     in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy~     for up to 2 weeks with assessment of baseline characteristics and glycaemic response.~     Participants will then enter an optional extension where they receive sulphonylurea or DPPIV~     inhibitor therapy in crossover fashion.~   "
92445|NCT01847131|"~     Background Allergic rhinitis is a common health problem with a worldwide prevalence is~     10-25%, and poses significant impact on the quality of life of the patients. In Thailand,~     the prevalence of allergic rhinitis in the general population is 13.5%, of which the~     frequency of allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the~     graduate students. Despite intranasal steroid being the current first-line treatment of~     patients with allergic rhinitis, only 60% of patients achieve excellent control. Persistent~     nasal congestion is the major symptom which is difficult to control in these patients. Data~     are limited about efficacy and safety of the additional use of 0.05% intranasal~     oxymetazoline hydrochloride (OXY) for persistent nasal congestion that does not adequately~     respond to recommended doses of intranasal steroid (INS) and oral antihistamine(OAH).~      Objective To determine the efficacy and safety of the additional use of OXY for persistent~     nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately~     controlled by combination treatment with INS and OAH.~      Methods The investigators performed a 6-week, randomized, double blind, placebo controlled,~     clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom~     inadequately controlled by combination treatment with INS and oral antihistamine (OAH).~     After an initial screening, qualified individuals were randomized into 2 groups including~     the treatment group and the control group. The treatment group received the INS (2 puffs in~     each nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril~     twice daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1~     tablet once daily) plus placebo (2 puffs in each nostril twice daily).~   "
92446|NCT01847118|"~     This study is to assess the safety, tolerability and pharmacokinetics of single dose and~     multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with~     advanced or metastatic solid tumors. The secondary objective is to explore the preliminary~     anti-tumor effects.~   "
92447|NCT01847105|"~     Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).~   "
92448|NCT01847092|"~     The purpose of this study is to determine if the study drug is safe, tolerable and active in~     reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.~   "
92494|NCT01846481|"~     This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male~     and female subjects with an American Psychiatric Association Diagnostic and Statistical~     Manual DSM-IV-TR diagnosis of cocaine abuse.~   "
92495|NCT01846468|"~     The purpose of the study is to provide pertinent information to enable decisions regarding~     the developability of LHW090 for use in patients with chronic renal insufficiency, including~     a comparison of the potential risk-benefit ratio of several doses of the study drug to~     enable optimal doses to be tested in later studies.~   "
92449|NCT01847079|"~     PROBIC~      Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU.~      Objective: The investigators suggest that PCT is a marker for blood stream infection in all~     patients in the ICU in whom attending physicians/ intensivists order blood culturing in the~     suspicion of microbial infection. The investigators want to demonstrate that its use for~     guiding blood culturing is cost-effective and safe compared with blood cultures alone.~      Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster-~     randomised cross-over clinical trial.~      Intervention (if applicable): The intensive care units will be allocated into two groups: a~     control group (blood culture) and the intervention group (procalcitonin).~      Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a~     mortality difference not exceeding a between groups difference of 10% by non-inferiority~     analysis.~      Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin~     testing from saved blood cultures compared with standard treatment spending on blood~     cultures in the control group.~      ICIS~      Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting~     microbial infection and its sequelae in critically ill patients in whom attending~     physicians/ intensivists order blood culturing in the suspicion of microbial infection.~      Objective: Because of the complexity of the pathophysiology of systemic inflammation it is~     unlikely that a single parameter will have sufficient diagnostic accuracy for infection.~     Therefore we will study combining parameters producing a diagnostic score.~      Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the~     ProBIC study.~      Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and~     collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived~     parameters which can be extracted using the same aliqnots.~      Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to~     enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.~   "
92450|NCT01847066|"~     To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the~     US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars~     and pigmented skin.~   "
92451|NCT01847053|"~     A partial double-blind, randomized, placebo-controlled, 4-treatment crossover study design~     will be used to evaluate bioavailability of various forms of cinnamon and to determine the~     effects of 3 and 6 g of cinnamon added to instant oatmeal on blood glucose levels in 8~     healthy subjects. In the extended dose response study, three subjects will continue the~     study and be offered 5 day consecutive feedings of 9 g cinnamon extract and on Day 6, and~     blood samples would be collected over 6 hours after a single morning dose. Urinary samples~     would be collected upon to 48 hours.~   "
92452|NCT01847040|"~     The study will provide evidence on the long term outcomes of mTBI in service members~     returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI~     incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will~     be combined with data on health care utilization and military job performance. The work,~     symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI,~     combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at~     one year. The assessments over time will permit descriptions of symptom changes for these~     populations. It is likely the study will find similar findings to those of previous civilian~     studies - that concussive symptoms often resolve within months of injury. However, some~     soldier subsets may have chronic problems. Determining the incidence and outcomes of~     individuals with mTBI will assist medical providers in determining the types of follow-ups~     needed by returning service members and suggest the development of additional treatment~     interventions. These results may also inform treatment of civilian populations with mTBI.~      The three primary hypotheses are:~        1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and~          symptoms persisting 3 months, 6 months, and 12 months after return will be associated~          with extent of exposure to combat, injury mechanism, associated injuries (co-occuring~          injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related~          mTBIs.~        2. Returning troops reporting concussive symptoms at the time of return from deployment~          will have more work related problems at each follow-up (including lower rates of return~          to duty, return to work, and poor quality of work).~        3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the~          criterion measure, which is a structured interview conducted by clinicians blinded to~          the screening results.~   "
92453|NCT01847027|"~     The purpose of this study is to see if an investigational supplement called NutraStem® will~     increase the amount of stem cells in human blood at rest and after exercise. The ingredients~     found in NutraStem® can be found in nutrition or vitamin shops/stores.~   "
92454|NCT01847014|"~     SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,~     Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to~     psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the~     long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401~     study.~   "
92455|NCT01847001|"~     This study is being conducted in patients with newly diagnosed breast cancer that will be~     undergoing chemotherapy prior to surgery - neoadjuvant chemotherapy. The study involves~     treatment with standard chemotherapy and a commonly used, FDA-approved, blood pressure drug~     called propranolol (Inderal). The purposes of this study are to:~        1. Determine the effect of propranolol plus chemotherapy on breast cancer cells as well as~          the growth of blood vessels surrounding breast cancer cells.~        2. Determine the side effect profile of propranolol and chemotherapy in patients with~          breast cancer receiving neoadjuvant chemotherapy.~      This research is being done because previous laboratory work has shown that propranolol may~     decrease the ability for the blood vessels around breast cancer cells to grow, which may be~     important in helping cancer cells grow. It also may reduce the likelihood for breast cancer~     cells to spread. If changes are seen in the breast cancer cells and surrounding blood~     vessels in this study, we will pan to evaluate whether propranolol decreases the likelihood~     of breast cancer from recurring in future, later studies. All chemotherapy regimens used in~     this study have been the standard of care for many years; however, the use of propranolol is~     being researched along with the chemotherapy regimens.~   "
92456|NCT01846988|"~     The purpose of this research study is to determine if auto-adjustable positive airway~     pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP~     is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to~     the upper airway (nose and throat) to keep the airway from collapsing while during sleep.~     The difference is that APAP adjusts the pressure throughout the night with changes in~     resistance during breathing, and CPAP gives the same amount of pressure the whole time it is~     worn. APAP is currently widely used to treat adults with OSA, however, this device has not~     yet been extensively studied in children.~      There are two parts to this research study. Subjects will begin using APAP at the time of~     enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the~     APAP device over the 4-8 weeks with the pressure determined by a CPAP titration study. The~     titration study is a second overnight sleep study that is routinely ordered when a child~     with sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be~     used.~      In the second part of this study The investigators will compare the effects of APAP with~     CPAP to see what is reported as more comfortable and is used during more hours of sleep.~     This part of the study will last about 8 weeks and each subject will use both CPAP and APAP~     for 4 weeks each.~      Currently when someone is diagnosed with OSA there is a delay in starting treatment with~     CPAP until the results of the titration study are available. In this research, patients~     could be allowed to immediately start treatment with APAP. If APAP is found to be as safe~     and effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.~   "
92458|NCT01846962|"~     Therapeutic strategies for eosinophilic esophagitis (EoE) actually include: 1) allergen~     avoidance through dietary modifications, and 2) pharmacologic antiinflammatory therapy.~     Medical treatment is mainly based on topical administration of corticosteroids by swallowing~     fluticasone propionate or budesonide spray. Dietetic treatment with highest efficacy is~     elemental diet, consisting in exclusive feeding with amino-acid based formulas, often~     administered trough SNG. Alternative choices of acceptable efficacy are empirical six-foods~     elimination diet (cow's milk, egg, soy, wheat, peanuts, fish) and targeted elimination diet~     based on the results of allergy tests. Most of the paediatric patients with EE respond to~     elemental or targeted elimination diets, and therefore such authors recommend elimination~     diets to be considered the treatment of choice in children. However, elimination diets can~     often be complex to follow and may be associated with poor adherence owing to the low~     palatability of a highly restricted diet. In non-compliant patients, especially in~     adolescents and young adults, it may be more practical to proceed first with corticosteroid~     treatment. In the case of partial response to elimination diets or corticosteroids, a~     combination of both treatment mod. However, there has been limited testing of these regimens~     in randomized controlled trials, while most of available literature is based on case series.~      The aim of this study was to compare the efficacy of six-foods elimination diet versus~     swallowed fluticasone versus budesonide in pediatric patients with active EoE. The~     investigators assessed the effects of randomly assigned treatment on clinical and~     endoscopic/histologic severity as primary and secondary outcomes, respectively. In~     addiction, we assessed the efficacy of combined therapy (diet plus topical steroids)~     administered to non responding patients. The investigators describe clinical,~     allergological, endoscopic and histological features, and pH study results, of our pediatric~     population.~   "
92459|NCT01846949|"~     This study is intended to be a prospective observational study at multiple sites, not a~     randomized controlled trial (RCT). The uses of the biomarkers has been approved by~     government regulations and adopted for surveillance programs in some countries, thus an RCT~     which compares patients followed by US alone with patients followed by both US and the~     biomarkers would raise an ethical conflict, especially in countries where the biomarkers~     have been routinely used.~      For this study, enrolled patients will be followed by US and the biomarkers at regular~     intervals and classified after completing the study to evaluate the clinical effectiveness~     of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with~     respect to tumor characteristics will be made among US alone, the biomarkers, and combined~     use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be~     investigated in this study.~   "
92460|NCT01846936|"~     One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial~     blocker (BB). In this study, the investigators compared the effectiveness of lung collapse~     using DLT, BB with spontaneous collapse, and BB with disconnection technique.~   "
92461|NCT01846923|"~     The purpose of this study is to determine whether one dose of the 13-valent pneumococcal~     conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether~     previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine~     influence the cellular immune response to PCV13 in this group.~   "
92462|NCT01846910|"~     The objectives of this study are:~        1. To determine the effect that an intensive, community dental clinic centered,~          stop-smoking program using a motivational interviewing approach has upon cessation~          rates for interested, smoking inner-city dental patients.~        2. To determine the effect that providing a tooth whitening incentive, in a community~          dental clinic stop-smoking program, has upon cessation rates for interested, smoking~          inner-city dental patients.~   "
92463|NCT01846884|"~     To collect and process urine samples from critically ill subjects for use in assessing the~     effects of various urine sample freezing and storage conditions on biomarker test results.~   "
92464|NCT01846871|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the study drug tivozanib is still being studied. It also means~     that the FDA has not yet approved tivozanib for your type of cancer.~      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking~     the blood supply to the tumor, so that the tumor does not receive the nutrients it requires~     to grow.~      In this research study, we are looking to see what effects, good and bad, tivozanib will~     have on you and your disease.~   "
92465|NCT01846858|"~     Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating,~     particularly when associated with bowel evisceration. A review of records from 1970 - 2001~     at the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff~     dehiscence after pelvic operation via both abdominal and vaginal approaches3. At a single,~     large, tertiary care facility, total laparoscopic hysterectomy (TLH) was associated with an~     increased incidence of vaginal cuff dehiscence compared to other approaches (4.93% vs. 0.29%~     TVH, and 0.12% TAH)1. A review of our robotic experience revealed a vaginal cuff dehiscence~     incidence of 4.1%, which is comparable to the previously reported incidence for TLH2. An~     increasing number of laparoscopic hysterectomies are being performed in the United States~     with the rate of laparoscopic procedures increasing from 0.3% in 1990 to 11.8% in 20034.~     With 11.8% of 600,000 annual hysterectomies being performed via the laparoscopic route in~     the United States, there would be an estimated 3,400 cases of vaginal cuff dehiscence per~     year.~      The cause of the higher rate of vaginal cuff dehiscence in both laparoscopic and robotic~     hysterectomies is currently unknown. One of the major differences between the laparoscopic~     and robotic approach as compared to the vaginal/abdominal route is the method by which the~     cervix is amputated from the vagina. With the vaginal and abdominal approaches, a colpotomy~     is made sharply with a knife or scissors. In contrast, the colpotomy is performed with~     electrocoagulation with the laparoscopic and robotic routes. One theory to explain the~     increased dehiscence incidence is the lateral thermal effects of electrocoagulation on the~     vaginal cuff which may adversely affect tissue healing.~      This study aims primarily to shed light on the etiology of vaginal cuff healing after a~     robotic total hysterectomy. This will be done by comparing the extent of thermal injury at~     the cellular level using monopolar vs CO2 laser at the time of the colpotomy.~   "
92466|NCT01846845|"~     The purpose of the study is to evaluate residual limb circulation and skin health associated~     with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis~     will be compared to the novel transfemoral socket system.~   "
92467|NCT01846832|"~     The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks~     of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV)~     in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C~     Virus (HCV) infection.~   "
92496|NCT01846455|"~     The objective was to determine if hepatitis C virus (HCV) infection or mild to severe~     hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine,~     norbuprenorphine, or naloxone.~   "
92497|NCT01846442|"~     The purpose of this study is to determine the dose-response of vaginal mucosa parameters to~     the local action of DHEA in postmenopausal women suffering from vaginal atrophy.~   "
92498|NCT01846429|"~     The purpose of this study is to:~        -  Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses~          than those usually given for heartburn.~        -  Determine if sodium bicarbonate can reduce cancer-related pain.~   "
92973|NCT01840241|"~     In this single-site, randomized, controlled and double-blind clinical trial, the~     investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury~     in high risk patients undergoing off pump coronary bypass surgery.~   "
92469|NCT01846806|"~     This is a prospective study designed to examine the role of bacterial overgrowth and delayed~     intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study~     is divided into Phase A and Phase B. The purpose of Phase A is to test patients with~     cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal~     transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the~     improvement found in patients with hepatic encephalopathy taking Rifaximin is also related~     to decreased bacterial overgrowth.~      Subjects' mental capacity will be assessed at each visit via interview, brief mental status,~     questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to~     continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness,~     concentration, or understanding of evaluation, will be discontinued from the study. Female~     subjects of childbearing potential will be asked to comply with the use of contraception~     during the Phase B study period as well as throughout the time they remain on study drug.~   "
92470|NCT01846793|"~     This study is designed to demonstrate the safety and efficacy of a second transrectal~     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia~     (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of~     NX-1207.~   "
92471|NCT01846780|"~     Patients with unilateral post-thrombotic obstruction of the iliac tract and or common~     femoral vein, eligible for stenting are included. Intravenous pressure is measured in both~     dorsal foot veins and both common femoral veins. Patients are asked to undergo a~     standardised treadmill test (3.2km/h, 0% slope that increases by 2%/2min, maximum walking~     time 26 min). Painfree and maximum action radius are noted.~   "
92472|NCT01846767|"~     The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in~     type 2 diabetic patients.~   "
92473|NCT01846754|"~     The prevalence of end stage renal disease in Taiwan was listed first all over the world.~     Fatigue, which makes patients unable to be competitive to play their functional roles, is~     one of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing~     back to the development of its relating studies, there is no accurate reason that why does~     people undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not~     shown up yet. Paper review indicated that the level of L-Carnitine concentration, which~     affect metabolism of fatty acid, had correlation with fatigue and muscle strength in this~     population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When~     there is deficiency of energy supply, it resulted to decline of muscle strength, which~     increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to~     understand the basic condition of fatigue level, muscle and metabolism of fat and~     carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength,~     metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among~     demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction~     ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive~     protein), mental and social conditions (depression, anxiety, and social support), muscle~     strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.~      The study use cross-sectional descriptive correlative design with consecutive sampling.~     Recruit patients from a hemodialysis unit in a medical center in north Taiwan after~     informed- consent. The estimated sample size is 100. To understand relationship among muscle~     strength, by-products of fatty acid and carbohydrate and fatigue, we collect data by~     measuring their muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood~     test data and the structured questionnaires which included mental/social data (depression,~     anxiety, social support and fatigue level). Descriptive statistics, ANOVA, Pearson's~     correlation, Spearsman's rank correlation and stepwise regression were used to analyze the~     collected data. Hope this research can get advance in comprehension of cause of fatigue and~     improve the fatigue symptom of hemodialysis patients.~   "
92474|NCT01846741|"~     Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage~     2) of the Model 106 VNS implantable pulse generator~   "
92475|NCT01846728|"~     Menopause is associated with weight gain, but the reasons why are not clear. In this study,~     the investigators will determine if reducing estrogen levels causes a decrease in the~     ability of the body to produce heat. If so, this would suggest this is one way that~     menopause may cause weight gain.~   "
92476|NCT01846715|"~     The primary purpose of this study is to assess the safety and optimal delivery of the~     Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from~     expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's~     kidney biopsy.~   "
92477|NCT01846702|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3084077 in healthy participants. The study will also investigate how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it.~     Information about any side effects that may occur will also be collected. The study is~     expected to last approximately 8 weeks for each participant.~   "
92478|NCT01846689|"~     The objective of this study is to measure the change in blood values after the~     administration of an amino acid based erythropoietin stimulating system.~   "
92479|NCT01846676|"~     -  Introduction: Hearing loss is a prevalent condition in elderly population. However, the~          low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In~          2007 there was designed a rehabilitation program called ACE, which aims to improve~          rehabilitation directed to hearing aids users. The study hypothesis is that a~          counseling program will improve adherence to hearing aids in elderly population.~        -  Objective: To evaluate the utility of a standardized counselling program in patients~          with hearing loss.~        -  Material and Methods: A before/after trial will be carried out, approved by the~          Hospital ethics - committee. Patients with 65 years and older with hearing loss~          diagnosed by pure tone audiometry will be included. To assess adherence we will use the~          IOI-HA scale.~   "
92480|NCT01846663|"~     The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with~     severe hepatic impairment and Hepatic Encephalopathy.~   "
92481|NCT01846650|"~     1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg~          (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets~          (Manufactured by Roche Pharma AG)~        2. Experimental Design： Two-period crossover design~        3. Test drug: Capecitabine tablets Reference drug: XELODA~        4. Sample size：24~   "
92482|NCT01846637|"~     The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first~     one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away~     from the pylorus.~   "
92483|NCT01846624|"~     This phase 2 study evaluates the sequential combination of decitabine then midostaurin for~     the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.~   "
92484|NCT01846611|"~     The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a~     third-line chemotherapy regimen (treatment) in patients with platinum-sensitive~     advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who~     received 2 previous lines of platinum-based chemotherapy.~   "
92485|NCT01846598|"~     Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12~     hours, and the peak period of 48 hours to achieve healing.The traditional postoperative~     wound care was every 1-3 days clean with saline and gauze or other dressing and not opened~     .In traditional concept the wound touch the water that will increase the rate of wound~     infection.England Department of Health in 2008 surgical wound care guidelines about surgery~     wound cleaning solution comparison. It was no significant difference in wound infection.with~     normalsaline and tap water. 2012 The Cochrane Collaboration: Water for wound cleansing~     systematic review of the literature that wound clean water has no effect on the rate of~     wound infection and healing rate, conducive to personal hygiene and cost-effective. Under~     high temperature and humid environments in our country, after surgery not bathe often affect~     patients' satisfaction and increase the cost of dressing and manpower, Was opened a line~     after surgery the wound can be shower? It is important about surgical wound care guidelines,~     but also the patient daily asked a high degree of issues. Purpose of this study (1)~     post-operative 48 hours, shower or not wound infection rate (2) post-operative 48 hours,~     shower or not the pain score (3) post-operative 48 hours, shower or not the comfortable (4)~     post-operative 48 hours, shower or not the care costs.~   "
92486|NCT01846585|"~     The aim of the study is to improve sleep during pregnancy and the postpartum period in women~     who are experiencing insomnia, using a brief non-pharmacological treatment.~   "
92487|NCT01846572|"~     The aim of this study was to determine the prevalence rate and risk factors for chemical~     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.~   "
92488|NCT01846559|"~     Platelets are the main type of blood cell involved in the formation of blood clots that~     cause heart attacks. The investigators give antiplatelet drugs (aspirin, for example) to~     reduce the risk of another clot forming in the future and causing another heart attack.~     Platelets are known to have a role in inflammation and infection as well as clotting. In a~     recent large clinical trial, known as the PLATO study, it was also shown that patients~     treated with a new antiplatelet medication (ticagrelor) developed fewer lung infections, as~     well as fewer heart attacks, compared to the current standard treatment (clopidogrel). The~     investigators would therefore like to investigate the reasons behind this and look at the~     effect of these medications on immune response. This may help us develop new drugs that have~     a better effect on immune response. The investigators are planning a clinical trial that~     investigates the effect of these medications on the immune response of healthy volunteers~     aged 18 to 65.~      Only volunteers with no significant past medical history and not taking any medications will~     be included.~      Thirty volunteers will receive either a normal dose of ticagrelor or clopidogrel or no~     antiplatelet medication for 1 week.~      They will then attend the Sheffield Clinical Research Facility where their immune response~     will be stimulated using a safe, well established method. The investigators will do this~     with an injection of a low dose of endotoxin, which is part of the surface coating of some~     bacteria and has been used extensively in similar studies, in over a thousand volunteers~     over the past 20 years to investigate immune response. It is known to cause temporary~     flu-like symptoms that last approximately 68 hours. The investigators will take measurements~     of inflammatory markers, white blood cell function and platelet function and compare the~     effect of ticagrelor and clopidogrel on this immune response.~   "
92489|NCT01846546|"~     Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and~     modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous~     angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the~     secondary brain injury following TBI. The aim of this study was to investigate early changes~     in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations~     of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen~     XVIII concentrations were measured serially for 1 week after hospitalization by using the~     enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI~     and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to~     determine if its serial changes correlate with the GCS score and prognosis. Receiver~     operating characteristic curve was used to appraise the value of CSF endostatin/collagen~     XVIII levels in predicting the prognosis of patients with severe head injury.~   "
92490|NCT01846533|"~     Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures~     were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast~     function but decreases osteoblast function, thereby leading to accelerated bone loss,~     osteopenia and osteoporosis. (2)DM/hyperglycemia induces production of macrophage colony~     stimulating factor (MCSF), tumor necrosis factor (TNF)-α and receptor activator of nuclear~     factor-κB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast~     proliferation and differentiation. (3) DM/hyperglycemia suppresses osteoblast proliferation~     and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin~     and osteopontin expressions. (4)Adipogenic differentiation of mesenchymal stem cells is~     increased as indicated by the overexpression of adipocyte differentiation markers, including~     peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein~     (aP2), adipsin and resistin. A decrease in neovascularization may further aggravate bone~     loss. (5)Bone quality is also reduced as a result of advanced glycation end products (AGE)~     production, which may eventually result in low impact or fragility fractures. DM are~     associated osteoporosis/fracture. The underlying mechanism, especially of type 2 DM,~     mandates a DM-osteoporosis cohort to elucidate. In clinical practice, to developed~     preventive strategies from osteoporotic-fracture is also necessary.~   "
92491|NCT01846520|"~     This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in~     supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic~     and lung cancers. Education and telephone counseling may reduce stress and improve the~     well-being and quality of life of caregivers of cancer patients.~   "
92492|NCT01846507|"~     This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as~     Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and~     lead to an increase in the quality of life.~      Menorrhagia in young women with bleeding disorders is typically treated with a combination~     of treatments including hormonal contraceptives. However, there are barriers to hormonal~     contraception use in younger adolescents.~      Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.~      The purposes of this study include:~      To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda~     works in decreasing menstrual blood loss. To see if parents and children participating in~     this study think the drug is improving their quality of life.~      Lysteda has been approved by the Food and Drug Administration for use in patients > than 18~     years of age but not for younger patients.~   "
92493|NCT01846494|"~     The purpose of this study is to monitor the cardiovascular and renal health of patients who~     previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to~     hepatitis C infected patients who have never taken BMS-986094.~   "
92499|NCT01846416|"~     This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab~     (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC.~     Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab~     (MPDL3280A) on Day 1 of 21-day cycles until disease progression.~      Eligible participants will be categorized in to three groups as follows:~        1. Participants with no prior chemotherapy for advanced disease;~        2. Participants who progress during or following a prior-platinum based chemotherapy~          regimen for advanced disease (2L+participants);~        3. Participants who are 2L+ and previously treated for brain metastases.~   "
92500|NCT01846403|"~     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,~     we would like to document the feasibility and acceptability of a semi-quantitative pregnancy~     test as an adjunct to or replacement of current monitoring protocols to offer women and~     health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot~     will help us to better understand how this tool complements existing monitoring protocols.~     If a suitable addition, replacement to repeat blood draws for serum hCG assessment, the SQPT~     could also contribute to efforts to make assisted fertility treatments more~     patient-friendly. This study seeks to test this innovation by asking women assigned to~     perform a dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on~     a weekly basis for up to 4 weeks after embryo transfer.~      We hypothesize that the test, which can be used at home by women, will provide confirmation~     of the presence of a pregnancy compared with standard serum hCG testing because 1) it has~     sensitivity and specificity that correlates well with serum testing, and 2) it can be used~     at home and thus earlier to determine presence of hCG. Furthermore, a pregnancy can be~     assured only when a yolksac or embryo could be identified thus women have to wait for a~     period of 2-3 weeks after the next menses expected.~      We hypothesize that women seeking assisted fertility treatments will be able to monitor~     their hCG at home as well. Further, we plan to develop revised instructions to better suit~     the needs and questions we think would be relevant to women desiring to use this test as~     part of assisted fertility services.~      We hypothesize that the simple instructions we will develop for use in this study will~     enable women to use the test on their own. Provider counseling will complement these~     instructions and contribute to overall quality of care given to each participant.~   "
92501|NCT01846390|"~     This research is being done because it is not yet known what dose of romidepsin in~     combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to~     patients with peripheral T-cell lymphoma, nor what type and severity of side effects will~     result from the combination of these treatments. This research is also being done because it~     is not clear if the addition of the new drug romidepsin to treatment with GDP can offer~     better results and longer survival.~   "
92502|NCT01846377|"~     With the increasing rates of child obesity and diabetes, innovative programs are needed that~     capture children's attention and permit behavior change messages to get through. Serious~     video games with their immersive stories offer one such promising alternative due to their~     low cost approach to intervention since the games have already been developed, and can be~     broadly disseminated by simply reproducing and distributing their DVDs. While using video~     games for health promotion is controversial, this study will establish whether video games~     can effectively change diabetes and obesity risks (especially fasting insulin, diet and~     physical activity) among children.~      Escape from Diab and Nanoswarm: Invasion from Inner Space are two video games that~     targeted children to increase fruit, vegetable and water intakes, reduce sedentary behaviors~     (SB), and increase physical activity in a pilot study with a relatively low risk children.~     In light of this, it is important to test whether these games can help decrease diabetes~     (i.e. fasting insulin) and obesity risks with high risk (85%tile < BMI < 99%tile) 10 to 12~     year old children.~      Children will be randomly assigned to treatment or control groups. The treatment group will~     play Diab and Nano over a 3-month time period. A wait-list control group will receive~     the Diab and Nano games at the end of their second post assessment (5-months post~     baseline assessment).~   "
92503|NCT01846364|"~     Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables~     (such as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in~     recent years for its anti-cancer effects. DIM has been shown to exert control over cancer~     cell growth in breast, uterine, cervical, ovarian, and colon cancer.~      To date no human study has been published regarding the bioavailability of DIM in thyroid~     tissue or its effects in proliferative thyroid disease. Our previous study attempted to~     elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative~     thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to~     concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease~     subjectively.~      This study would continue our attempt to elucidate DIM's promotion of anti-proliferative~     estrogen metabolites in proliferative thyroid disease.~   "
92504|NCT01846351|"~     Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes~     of intravitreal anti-VEGF therapy for eAMD.~   "
92505|NCT01846338|"~     The aim of this study is to investigate the therapeutic effects of green tea extract on acne~     treatment and related hormone peptides by a double-blinded, randomized and controlled~     clinical trial.~   "
92506|NCT01846325|"~     Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in~     asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve~     it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds~     which are susceptible to oxidation and production of free oxygen radicals.~   "
92507|NCT01846312|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess longitudinal variation of immune biomarkers in subjects at risk for development of~     type 1 diabetes (T1D).~   "
92508|NCT01846299|"~     To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult~     patients with visual impairment due to macular edema (ME).~   "
92509|NCT01846286|"~     The goal of this research study is to learn more about chronic pain associated with cancer~     treatment.~   "
92510|NCT01846273|"~     This study will compare the effect of ranibizumab administered as monotherapy versus~     ranibizumab administered in combination with verteporfin PDT on visual acuity in patients~     with symptomatic macular PCV. The results of this study will provide long-term safety and~     efficacy data used to generate further guidance on the management of patients with PCV.~   "
92542|NCT01845857|"~     This survey will address important research, practice, and policy questions: How does~     Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their~     health behaviors, and their need for health care utilization? Who benefits most from the~     CDSMP program? Are predicted gains maintained over a six and twelve month period? Can~     critical clinical changes be seen for those who are diabetic?~   "
92511|NCT01846260|"~     Cognitive impairment associated with chemotherapy is an important reported post-treatment~     side-effect among breast and other cancer survivors. As some patients report cognitive~     complaints before the administration of their therapy, some authors suggest an association~     with psychological risk factors such as distress. Distress, a multifactorial unpleasant~     emotional experience of a psychological (cognitive, behavioral and emotional), social and/or~     spiritual nature that may interfere with the ability to cope with cancer effectively, its~     physical symptoms and its treatment, can easily be assessed by the Distress Thermometer.~      In this trial we aim to determine if the Distress Thermometer, accompanied by the 38-item~     Problem List, could predict cancer-related cognitive impairment in patients with hematologic~     malignancies, and in patients with gynecological, urological, breast, lung or~     gastro-intestinal cancer receiving curative radiotherapy, chemotherapy, radiochemotherapy,~     anti-hormonal or targeted therapy.~   "
92512|NCT01846247|"~     Phase 3, multicenter, international randomized controlled trial of a Very Early~     Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC).~     Participants receive either SC and VEM or SC alone in the acute phase of stroke up to a~     period of 14 days.~      Participants are followed up by a blinded assessor at 3 and 12 months post stroke to~     determine trial outcomes.~   "
92513|NCT01846234|"~     Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the~     differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were~     described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).~      However, the role of sodium intake in MS has not been investigated. In this study we~     investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological~     activity.~   "
92514|NCT01846221|"~     Epidural analgesia has proven to be an effective method for severe pain relief associated~     with labor and delivery. During labor, a low dose continuous infusion of local anesthetic~     and narcotic will be administered through an epidural catheter. As labor progresses and the~     baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs~     further treatment. The investigators provide pain relief by administering analgesics through~     the epidural catheter. The patients will be randomly assigned to receive one of two~     medication mixtures believed to be successful in treating this type of pain associated with~     advanced labor. After this initial treatment, if pain relief is not attained, the patient~     may receive the other medication as well. The medications used in this study have been used~     at this institution for some time and have been found to be safe for mother and baby. The~     opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby.~     The other medication (clonidine) better known as a blood pressure medication has also been~     used for pain relief. Studies and clinical experience have shown that clonidine when given~     epidurally in the doses used in this study has minimal, if any effect, on the blood pressure~     of the mother or of the baby. The investigators will record medical and obstetric history~     and labor progress relevant to the patient. The patient will be asked questions regarding~     labor pain and side effects before and after the analgesic is administered. The primary~     objective is to determine which treatment regimen is more successful in abolishing~     breakthrough pain in advanced labor.~   "
92515|NCT01846208|"~     The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing~     sustained unresponsiveness to egg exposure in children.~   "
92516|NCT01846195|"~     Non-invasive monitoring to measure changes in blood volume.~   "
92517|NCT01846182|"~     At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer~     from Gulf War Illness (GWI). Despite considerable research, effective treatments remain~     elusive. GWI refers to a complex of symptoms that typically include widespread chronic pain,~     persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep~     disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia~     syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have~     yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS.~     The lack of progress in finding effective treatments for GWI, and the similarities between~     GWI and FMS, provides a rationale for determining if these medications can provide relief to~     Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of~     Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.~   "
92518|NCT01846169|"~     This application, funded by the American Association of Retired Persons(AARP) Foundation, is~     to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative~     will address barriers of affordability, and reduced mobility by providing older adults with~     nutritious foods that are usually difficult to purchase due to high cost; delivering needed~     foods to individuals in their homes; tailoring food delivery frequency based on level of~     food insecurity; and offering basic nutrition education.~   "
92519|NCT01846156|"~     there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we~     need to make a trial to find the best protocol~   "
92520|NCT01846143|"~     The purpose of this study is to learn what effects (good and bad) experimental~     phosphopeptide vaccines plus a tetanus peptide and other substances called polyICLC and~     Montanide ISA-51 have on people with melanoma. The investigators will also look at whether~     the experimental reagents cause any changes in the immune system.~   "
92521|NCT01846130|"~     The loss of muscle mass and function in older adults during bed rest is facilitated by~     defects in the regulation of muscle protein metabolism, including an impaired ability to~     mount an anabolic response to a mixed nutrient meal. The investigators propose that~     low-intensity exercise and supplementing daily meals with leucine or whey will independently~     and synergistically reduce the deleterious effects of inactivity on skeletal muscle and~     facilitate recovery during rehabilitation. Metabolic measures will include: a) nutrient and~     exercise-specific markers of translation initiation; b) skeletal muscle protein synthesis;~     and c) a novel breath test of glucose tolerance. Morphologic and functional measures will~     include: a) muscle mass and body composition; b) muscle strength and function; and c) motor~     activation. The investigators will test the following hypotheses in older men and women~     (65-80 years) during 7 days of bed rest followed by 7 days of inpatient rehabilitation:~        1. Inactivity-induced metabolic dysregulation will blunt the anabolic response to meals,~          facilitating a loss of lean muscle mass, glucose tolerance and functional capacity that~          is partially restored during rehabilitation.~        2. Supplementing daily meals with leucine or whey will maintain nutrient-stimulated~          translation initiation and preserve the anabolic response to meal ingestion. This will~          partially preserve lean muscle mass and function during bed rest and facilitate the~          recovery of functional and metabolic capacity during rehabilitation.~        3. Daily low-intensity exercise will preserve motor unit activation, stimulate the~          exercise-regulated signaling pathway and normalize the anabolic response to meal~          ingestion. This will partially preserve glucose tolerance, lean muscle mass and~          function during bed rest and facilitate rehabilitation.~        4. Leucine or whey-supplemented meals combined with low-intensity exercise will be a more~          effective stimulus than either intervention alone, preserving glucose tolerance, lean~          muscle mass and function during bed rest and facilitating a greater increase in~          functional and metabolic capacity during rehabilitation.~      This translational project will provide mechanistic and practical insight into strategies to~     reduce the negative consequences of physical inactivity and promote rehabilitation in aging~     muscle. Our novel, minimally invasive and clinically interventions have direct application~     for older hospitalized patients at risk of accelerated muscle loss and diminished functional~     capacity.~   "
92522|NCT01846117|"~     The investigators are investigating whether the flax lignan, secoisolariciresinol~     diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed~     to be broken down in the body to produce the health benefits of flax. Flax lignan is~     separated from the whole flax seed as this compound is believed to have health effects.~     Decreasing oxidative stress and inflammation should improve a number of the problems~     associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG~     daily or an equivalent amount of whey protein.~      The investigators are comparing lignan to a placebo (whey powder) to examine whether a~     dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and~     inflammation.~   "
92523|NCT01846104|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg~     booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg~     doses of RVEc in a Phase 1 trial (NCT01317667).~   "
92524|NCT01846091|"~     This phase I trial studies the side effects and the best dose of viral therapy in treating~     patients with squamous cell carcinoma of the head and neck that has returned (come back)~     after a period of improvement or has spread to other parts of the body or breast cancer that~     has spread to other parts of the body. A virus called encoding thyroidal sodium iodide~     symporter, which has been changed in a certain way, may be able to kill tumor cells without~     damaging normal cells.~   "
92525|NCT01846078|"~     Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.~   "
92526|NCT01846065|"~     Investigators have recently completed a pilot study exploring the safety and efficacy of~     using a virtual-reality based cue platform to elicit craving in smokers with~     schizophrenia(SWS)(Wehring et al, unpublished). In this study, participants with~     schizophrenia (n=16) showed increased attention to cigarettes and changes in craving~     measures when participating in the VR craving platform. In addition, participants tolerated~     the VR environment without undue adverse effects or exacerbation of symptoms. Adverse~     effects from the VR environment did not differ from that in a non-mentally ill population,~     and included headache, nausea, and dizziness as most commonly occurring factors. Persons in~     this pilot also showed acceptable rates of Immersion and Presence in the VR environment,~     showing the potential use of this form of environment for this and other purposes.~      In this study, investigators will examine virtual reality cue-reactivity in smokers with~     schizophrenia, with a focus on the relationship of cue-reactivity with self-identified~     triggers/cues. Smokers with schizophrenia often identify specific cues that trigger craving.~     Many of these are environmental (scent, sight of smoking paraphernalia or cigarettes,~     related objects, or social situations), however, a significant amount of smokers describe~     emotionally-based factors (sadness, being upset, etc.) as primary cues and triggers. Most~     methods used to elicit craving in experimental studies are executed via using environmental~     cues like sight of cigarettes or smoking paraphernalia. It is not known if smokers with~     schizophrenia(SWS) who are strongly emotionally triggered will be responsive to~     environmental triggers in a cue-elicited craving platform. This is an important research~     question, as the testing of anti-craving interventions should be generalizable for use~     across SWS with differing triggers to smoking. The VR-based environmental program from our~     pilot study, which includes sight, scent, and social cues, will be used to test~     pre-identified environmental cues/triggers and their effects on cue-elicited craving in 30~     SWS. Subjective reports, mood and emotion measures, and objective physiological measurements~     will be used to identify and quantify environmental craving responsivity as well as tonic~     craving.~      Given the high prevalence of smoking among individuals with schizophrenia, understanding~     some of the environmental factors that serve to maintain nicotine dependence is a critical~     step in improving smoking cessation treatment outcomes. Establishing and validating a model~     of cue-elicited responsivity will allow future investigations of craving, and ultimately~     designs for studying the efficacy of anti-craving medications in people with schizophrenia.~   "
92527|NCT01846052|"~     The purpose of this study is to identify individuals with achromatopsia caused by mutations~     in the CNGB3 gene and characterize their clinical condition using several tests of visual~     function every 6 months for up to 1.5 years.~   "
92528|NCT01846039|"~     A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM~     VOLUMA® to enhance the aesthetic appearance of the Asian nose.~   "
92529|NCT01846026|"~     Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with~     bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased~     permeability. Several cytokines are described to mediate the progressive course of~     ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC~     have often low levels of vitamin D and elevated prevalence of osteoporosis.~      In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a~     direct healing action on colonic mucosa has been described in animal studies. One can~     therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with~     UC. To our knowledge, it has not been performed randomized clinical trials to study these~     possible effects of vitamin D and it has not been studied the effects of vitamin D on the~     relapse frequency and immunological composition of colic mucosa in patient with moderate to~     severe ulcerative colitis.~      Objectives for our study are as follows: To examine if high-dose vitamin D supplementation~     in patients with moderate to severe ulcerative colitis:~        -  reduces relapse frequency and increase the duration of the Infliximab induced remission~        -  mediates and changes the cytokines composition in the colic mucosa~        -  decreases the excretion of calprotectin in feces and reduces the concentration of~          inflammation markers~        -  augments bone mass~   "
92530|NCT01846013|"~     Purpose:~      The purpose of this study is to implement and evaluate a randomized controlled trial in~     sitting office workers to reduce sitting time through the use of motorized and non-motorized~     sit/stand workstations as well as a walking intervention.~      Hypotheses:~        1. Compared to the control group, total physical activity will be higher in the standing~          and walking intervention groups.~        2. The combined standing and walking group will have higher total physical activity than~          the other three groups.~        3. Compared to the control group, the fitness and health outcomes will be improved for the~          standing and walking groups.~   "
92531|NCT01846000|"~     The purpose of this study is to assess the effect of low-level laser on pain, occlusal~     contacts, mandibular movements and electromyography activity in the masseter and temporal~     muscles in adolescents with TMD.~   "
92532|NCT01845987|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959~     following subcutaneous administration in participants with palmoplantar pustulosis.~   "
92543|NCT01845844|"~     This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in~     subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab~     (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at~     least 6 bevacizumab injections within 9 months of enrollment).~   "
92675|NCT01844128|"~     Obesity affects on fertility. Obese women have lower pregnancy rate after infertility~     treatments.They need more doses of hormone during ovarian stimulation, more days for~     stimulation. During IVF treatment less oocytes are collected and the quality of embryo also~     harmed.~      The first line treatment for those women with obesity and infertility is weight loss.~      The investigators' hypothesis is that weight reduction improves ovarian reserve and~     fertility treatment outcome.~   "
92533|NCT01845974|"~     This study is examining data elements of hemodynamic, electrophysiologic and electrolyte~     trends comparing 2 different types of catheters used during a procedure to treat medication~     resistant atrial fibrillation- an irregular heart beat- called radiofrequency catheter~     ablation. A high flow catheter delivers a higher volume of saline during the procedure. The~     low flow catheter delivers a lower volume of saline during the procedure. The patient will~     be consented and randomized to one of the 2 groups using a computer generated randomization~     chart. Those that are put in the low flow catheter group will be considered the experimental~     group. All data will be collected before and after the procedure and each patient will act~     as their own control within each group. The hypothesis is that using a lower flow catheter~     will cause less hemodynamic, electrolyte, and electrophysiologic derangements resulting in~     better patient outcomes and fewer complications~   "
92534|NCT01845961|"~     The objective of this proof-of-concept pilot study to evaluate galantaminehydrobromide~     extended-release (ER) as a potential smoking cessation aid in treatment-seeking smokers.~   "
92535|NCT01845948|"~     This study tested the effectiveness of a parental training programme to enhance parent-child~     relationship and reduce harsh parenting practices and parental stress in the preparation of~     children for transition to primary school. A randomized controlled trial was employed and~     142 parents were recruited. Parents in the experimental group engaged in less harsh~     parenting practices and reported better parent-child relationships than parents in the~     control group. Findings from this study provide empirical evidence of the effectiveness of~     the parental training programme and highlight the significance of parental involvement in~     promoting a smooth transition for children from kindergarten to primary one.~   "
92536|NCT01845935|"~     To now, two alternatives for the management of venous vascular malformations are recognized,~     appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is~     effective on symptoms in 80% of cases and excision removes the malformation completely or~     partially, but it is aggressive and recurrences are common.~   "
92537|NCT01845922|"~     The study is based on a master thesis which showed that 72% of patients with head and neck~     cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding~     syndrome after admission.~      Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops~     after the reintroduction of an adequate food intake after a longer period of starvation or~     semi-starvation. This normally happens within 7 days after reintroduction of food.~      The aim of this study is to minimize the incidence of refeeding syndrome in this group of~     patients by reintroducing food slowly and by providing a diet low in sodium and high in~     slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease~     in plasma phosphate levels appear). Both patients that eat normally, patients with eating~     tubes and patients with central vein catheters are included in the study, but the data will~     be evaluated both together and separately.~   "
92538|NCT01845909|"~     The investigators have created a way of quickly collecting information in a large scale~     young population regarding the presence of some severity indicators that may allow us to~     classify them into: seemingly low risk and possible elevated risk for the presence of~     heart disease. It would have to be a short questionnaire, in order to receive a great~     adherence but that could simultaneously provide precise information, with an adequate~     description of symptoms and warning signs, in a way that a triage in the young adult~     population could be performed in the general young adult population in order to select~     individuals with an indication for personalized clinical evaluation and possible need of~     complementary diagnostic means. Based on this premise the investigators have developed a~     fast-response questionnaire named the Sudden Cardiac Death Screening Of risk factorS~     (SCD-SOS). This questionnaire has already been tested in a population of approximately 1500~     young adults, and some changes have been introduced in order to refine its performance.~      To best of the investigators knowledge, there are no large scale European surveys estimating~     the prevalence of cardiac disease and associated clinical symptoms in a non-selected~     (non-athlete) population of this age group.~      Purpose: To screen a young adult population from central regional of Portugal for heart~     disease possibly associated to a high risk of Sudden Cardiac Death (SCD).~      To determine the national prevalence of clinical symptoms of heart disease and of heart~     disease with increased risk for SCD in this age group.~      To detect young adults in risk of SCD and with an indication for evaluation by a~     cardiologist, and possible need of:~        -  medical treatment~        -  electrophysiologic (EP) study and percutaneous ablation~        -  an implantable cardiovertor defibrillator~        -  a pacemaker~        -  other type of specialized cardiac intervention~   "
92539|NCT01845896|"~     The purpose of this study is to investigate the effects of a combined training programme and~     a high intensity interval training programme on insulin resistance, muscle strength/ muscle~     contractile properties, aerobic capacity and body composition in MS patients.~      It is assumed that the the above mentioned clinical parameters will improve due to physical~     exercise.~   "
92540|NCT01845883|"~     In this proposal the investigators have three Specific Aims using human patient populations~     as model systems; 1) identify a role for the Basal Ganglia (BG) in perceptual decision~     making; 2) determine whether the Basal Ganglia contribute to decision making under~     conditions of visual uncertainty; 3) determine whether the cerebellum plays a role in~     perceptual decision-making under conditions of visual uncertainty. The investigators~     designed experiments using healthy humans and humans with diseases known to affect the Basal~     Ganglia and the cerebellum, Parkinson's Disease, dystonia and non-dystonic cerebellar~     damage. With this approach the investigators will test the following hypotheses: 1) Patients~     with Parkinson's Disease and dystonia will have more difficulty than healthy controls making~     perceptual decisions when faced with sensory uncertainty; when sensory information is~     certain, patients will show improved decision-making but will still be impaired relative to~     healthy humans. Hypothesis 2: If ambiguous sensory information is aided by prior~     information, patients with Parkinson's Disease and dystonia will be unable to use the prior~     (bias/memory) information to inform their decisions. Hypothesis 3: Deep Brain Stimulation~     (DBS) of Basal Ganglia structures will improve the ability of patients to use prior~     information to inform their decisions when faced with sensory uncertainty. Hypothesis 4:~     Both cholinergic and dopaminergic medical therapies will improve the ability of patients to~     use prior information to inform their decisions. Hypothesis 5: Patients with non-dystonic~     cerebellar damage will be similar to healthy controls in performance of a perceptual~     decision making task in conditions of visual uncertainty. The overarching framework of this~     application is that the same mechanisms (D1 striatal synaptic plasticity) that operate in~     reward learning play a role in learning and using stimulus priors in a perceptual~     decision-making task when faced with uncertainty. Because Parkinson's Disease and dystonia~     share deficits in striatal circuitry, the patient deficits on this task will be similar.~     Because non-dystonic cerebellar patients do not have dysfunction of striatal circuits, they~     will show no deficits in the ability to use stimulus priors to guide choices in uncertain~     conditions. In the event these patients do show deficits, this is will provide evidence for~     an unexplored role for the cerebellum in perceptual decision-making.~   "
92541|NCT01845870|"~     Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may~     be presented with the characteristics of albuminuria, and its main pathological change is~     glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis,~     glomerular basement membrane thickness and tubulointerstitial fibrosis have been found in~     both type 1 and type 2 diabetic patients with normal urinary albumin excretion rate,~     moreover the tubular injury may be the primary pathological change in diabetic renal injury~     not only the secondary change brought on by glomerular injury. Thus, if overt urinary~     albumin exists in T2DM patients, the tubular injury may be severe already. An index which is~     predominant, sensitive and convenient to be measured should be purposed.It is predicted that~     insufficient renal 1-alpha hydroxylase may play a critical role in diabetic nephropathy.~     Then the investigators present the presumption that the activity of renal 1-alpha~     hydroxylase could reflect the degrees of tubulointerstitial injury, using serum~     1,25-dihydroxyvitamin D level as an index.~   "
92544|NCT01845831|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the~     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot~     study aiming to determine differences in glycemic control between treatment with sitagliptin~     (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general~     medicine and surgery patients with type 2 diabetes (T2D). The investigators found that~     treatment with sitagliptin alone or in combination with basal insulin resulted in similar~     glycemic control compared to basal bolus regimen.~      The investigators will conduct a prospective RCT aimed to determine the safety and efficacy~     of sitagliptin therapy for in-hospital and post-discharge management of general medicine and~     surgical patients with T2D. A total of 280 patients with known history of diabetes will be~     randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or~     basal bolus regimen with glargine once daily and aspart or lispro insulin before meals~     (group 2). If needed, patients in the treatment groups will receive correction doses of~     rapid-acting insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall~     hypothesis is that treatment with sitagliptin in combination with basal insulin in patients~     with type 2 diabetes will result in a similar improvement in hospital and post-discharge~     glycemic control and in a lower frequency of hypoglycemic events than treatment with basal~     bolus insulin regimen with glargine once daily and lispro insulin before meals.~      Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University~     of Michigan, Ohio State University and Temple University~   "
92545|NCT01845818|"~     This observational study will document to what extend in daily clinical practice the work~     productivity is affected before and after the start of adalimumab treatment.~      Changes in the employment status and work productivity of patients with AS and PsA before~     and after the start of Adalimumab will be noted. The relationship between employment status,~     work productivity, disease activity and clinical evaluations will be evaluated. Since AS and~     PsA might be very invalidating diseases with a strong impact on the daily life of the~     patient, an evaluation will be performed to the effect of the disease on Quality of Life and~     work productivity.~   "
92546|NCT01845805|"~     To improve progression free survival in high risk patients with resected pancreatic~     adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in~     CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion~     of adjuvant therapy.~   "
92547|NCT01845792|"~     Patients are being asked to take place in this research study because they have advanced~     prostate cancer that has gotten worse after other treatments. If they join this study they~     will receive a new combination of drugs that are used to treat prostate cancer.~   "
92548|NCT01845779|"~     Complete response is a rare event in metastatic anal cancer in the case of unresectable~     recurrence after radiochemotherapy.~      In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were~     treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel,~     Cisplatin and 5-Fluorouracil.~      In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV)~     infection, that is the case of this patients for which HPV16 (human papillomavirus type 16)~     genotype was identified within the tumor samples.~      The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with~     DCF and contributed to the elimination of the tumour cells and to the increase of complete~     responses. The aim to this study is to analyze immune response against HPV in this patients~     in complete response.~   "
92549|NCT01845766|"~     We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic~     shock would decrease their functional disability and cognitive impairment. We plan to enroll~     patients with severe sepsis and septic shock who admitted an urban teaching hospital in~     Seoul, South Korea via ER. We will randomize those subjects into the intervention group~     which will take a standardized rehabilitation with routine clinical care for sepsis and the~     control group which will take routine clinical care for sepsis. And, we plan to assess their~     functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time~     of enrollment, 28 days, and 6 months later.~   "
92550|NCT01845753|"~     A clinically applicably strategy for molecular screening for Lynch Syndrome is being~     implemented in Denmark.~      Based on sequential analysis with immunohistochemistry and methylation analysis, patients~     with possible hereditary colorectal cancer are identified. These patients are offered~     genetic risk assessment and counselling.~      The study hypothesis is that molecular screening will identify more patients with Lynch~     Syndrome than the family history alone.~      Prospective data collection is performed using established clinical databases.~   "
92551|NCT01845740|"~     Milatuzumab will be given subcutaneously at different dose levels once (depending on the~     dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).~   "
92552|NCT01845727|"~     The proposed study encompasses a two-step approach. The first aiming to determine the safety~     of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in~     subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in~     having and indication of the efficacy of the two above mentioned regimens of Topical 3%~     Amphotericin B Cream~      For the first step, 30 subjects will be randomly assigned to receive direct observed~     treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per~     day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each~     group) have been enrolled and completed the 28 day treatment course. An interim analysis of~     all safety (Adverse Events, including local reactions and lab parameters) and~     pharmacokinetics collected on subjects who were randomized will be performed by data safety~     monitoring board. If no serious adverse events (SAEs) related to the study drug are~     identified on the first 30 subjects by the end of the treatment course, 50 additional~     subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three~     or two times per day for 28 days~      Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5~     days and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as~     measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization~     of the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to~     Day 180 for final analysis of efficacy.~   "
92553|NCT01845714|"~     Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on~     vision-specific quality of life. This study attempts to confirm this statement and assess~     whether cross-linking and cross-linking combined with photorefractive keratectomy improve~     vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.~   "
92606|NCT01845025|"~     The purpose of this study is to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in~     adolescents and adults (12 years of age and older) taking inhaled formoterol~     fumarate/fluticasone propionate combination is the same as those taking inhaled fluticasone~     propionate alone.~   "
92554|NCT01845701|"~     To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~     comparison with artemether-lumefantrine during 42 days follow up period in 720 children with~     acute uncomplicated P. falciparum malaria, in two different endemic ecological areas -~     Savanna and equatorial forest regions of Cameroon.~      We have set as specific objectives:~        -  To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~          comparison with artemether-lumefantrine during 14 and 28 days follow up period in~          children with acute uncomplicated P. falciparum malaria in two different endemic areas.~        -  To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~          comparison with artemether-lumefantrine during 42 days follow up period in children~          with acute uncomplicated P. falciparum malaria.~        -  To determine parasite clearance time (PCT) and fever clearance time (FCT) following the~          administration of the three trial regimens.~        -  To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in~          all groups after trial.~        -  To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of~          genes associated with drug resistance~   "
92555|NCT01845688|"~     The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen~     Granule to treat idiopathic membranous nephropathy.~   "
92556|NCT01845675|"~     Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in~     well-differentiated pancreatic neuroendocrine tumor~   "
92557|NCT01845662|"~     Purpose: Non-traumatic rupture of the spleen should be suspected when patients (especially~     young men) present with abdominal pain and a history of acute infectious or~     myeloproliferative disorders. Preoperative imaging studies in hemodynamically stable~     patients may obviate the need for surgery even in the presence of massive hemoperitoneum.~     The purpose of this research is to inform acute management where spontaneous rupture is~     suspected in order to avoid surgery where appropriate, rationalise angiographic intervention~     and blood transfusion.~      Hypothesis: Indentifying the cause of injuries can help target preventative intervention.~      Background: Non-traumatic rupture of the spleen is a rare condition. It may occur in the~     diseased spleen secondary to a variety of pathologies including malaria and~     myeloproliferative disorders. In some cases rupture may occur in an apparently normal~     spleen. The incidence, symptoms, causes, therapy and prognosis are poorly defined. The~     investigators, therefore, propose an extension of retrospective analysis conducted,~     presented and published in 2003 to examine all the cases of non-traumatic splenic rupture~     treated at Ziv Medical Centre from the last 26 years to present.~      Methods: Analysis of the medical notes of all patients with spontaneous splenic rupture in~     the medical archives.~      The investigators hope to determine the true incidence of this condition within the local~     population, increasingly diverse in origin, travel and the incidence of predisposing~     infectious disease; and to devise a practical protocol in their safe diagnosis and~     management, especially as non-operative interventions have grown in safety and~     effectiveness.~      Discussion: Although rare, spontaneous splenic rupture may be fatal if not suspected or~     treated inappropriately. Understanding the pitfalls in diagnosis and management better~     informs decision making towards improved care of these patients.~   "
92558|NCT01845649|"~     The purpose of the study is to determine if WC3011 is safe and effective in treating the~     symptom of painful intercourse secondary to vulvovaginal atrophy as measured by subject~     self-assessment when compared to vehicle.~   "
92559|NCT01845636|"~     Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology~     in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal~     lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal~     cortex and several other regions, occur in AD and strongly predict mild cognitive impairment~     (MCI) conversion to AD. Our pilot data, along with converging findings in the literature,~     suggests that odor identification deficits, both incremental change over time and change in~     response to an anticholinergic challenge, may be clinically simple, relatively inexpensive,~     predictors of cognitive improvement with acetylcholinesterase inhibitor (ACheI) treatment~     with potential clinical implications for predicting improvement and monitoring ACheI~     therapy.~   "
92560|NCT01845623|"~     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of~     indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to~     determine whether the novel device has a similar clinical profile as the established concept~     1 device.~   "
92561|NCT01845610|"~     Complementary food supplements (CFS), fortified products that are mixed with the infant's~     usual complementary foods, have the potential to improve nutrition among infants. In Africa,~     maize is a major staple food used for complementary feeding. Compared to rice or wheat,~     maize has higher levels of phytates, which bind trace elements such as iron and zinc, and~     inhibit their absorption. The impact of CFS products in the context of a maize-based diet~     has not been well investigated. This study will test two newly developed fat-based CFS~     products made from soy.~      The first product is a fortified fat-based spread that contains essential fatty acids with~     added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and~     zinc bioavailability. The second product is a fortified fat-based product containing~     essential fatty acids. Both products contain soy. The enrichment of the products with~     essential fatty acids is of particular interest in the South African context, as consumers~     are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high~     LA-containing sunflower oil during food preparation. The CFS products could contribute~     towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.~      The results of this study will provide evidence on whether or not two types of fortified CFS~     have the potential to address malnutrition (linear growth) and improve psychomotor~     development in infants. If proven effective, this approach of providing multiple nutrients~     can be made available to infants in the developing world and may lead to sustainable~     actions.~   "
92562|NCT01845597|"~     The purpose of this study is to determine the survivorship rate of robotic assisted medial~     partial knee replacement at a two, five, and ten years.~   "
92563|NCT01845584|"~     Patients diagnosed with anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum~     disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion~     criteria and do not conflict with the exclusion criteria will receive steroid plus therapy~     （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect~     of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin)~     400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and~     spinal cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional~     Systems （FS） and anti-aquaporin 4 antibody et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
92676|NCT01844115|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).~   "
92564|NCT01845571|"~     Background:~      Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair,~     often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia~     and aging which cause retinal tears often resulting in retinal detachment. Patients commonly~     experience photopsia, floaters, and peripheral visual field loss.~      Two different general surgical treatment options exist for retinal detachment; scleral~     buckling or vitrectomy. However, the precise indications for each approach have not been~     well established. Correct classification of the retinal detachment is important. The first~     step is to decide whether an intra- or extra-ocular surgical approach is more appropriate.~     Simple rhegmatogenous retinal detachments are usually treated extraocularly with scleral~     buckling surgery, whereas more complicated cases require intraocular primary pars plana~     vitrectomy and one or more of gas, silicone oil, laser therapy, or cryotherapy.~      Study objectives:~      The purpose of this study is to evaluate different surgical techniques for the treatment of~     retinal detachment. Data relating to retinal status before treatment, surgical treatment,~     post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative~     complications will be collected.~      Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of~     retinal detachment.~   "
92565|NCT01845558|"~     The aim of the current study is to investigate the therapeutic effect and especially the~     mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes,~     on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with~     medium proficiency level compared to placebo.~   "
92566|NCT01845545|"~     Investigators propose a feasibility and pilot study for a cluster randomised controlled~     trial. The proposed trial will evaluate the effects of an economic intervention~     (microfinance) in self-help groups of poor and marginalised women in three provinces in~     northern India, upon the health of these communities, with a focus on children under five~     years. This feasibility and pilot study will determine whether accurate data can be~     collected on mortality by means of a house to house survey or from the register of births~     and deaths. The feasibility stage will also determine whether village volunteers can~     accurately weigh children under five and record their weights alongside the financial data~     already recorded by the self-help group. If these data are accurate and can be collected~     reliably, the investigators will calculate the power and sample size needed for a future~     cluster randomised trial, as well as analysing preliminary results from the current project.~     The investigators will evaluate health outcomes, relating to two Millennium Development~     Goals: number of children under five years of age who are underweight and the under five~     mortality rate.~   "
92567|NCT01845532|"~     Laparoscopic operative procedures have revolutionized gynecological surgery. These have~     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter~     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues~     to be one complication, which results in an unpleasant experience for the patient and at~     times causes a delayed discharge. Trigger point injection removes the pain developing point~     and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin.~     An literature showed that patch of local anesthetics showed the effect of trigger point~     inject. The purpose of this study is to investigate the alleviation of shoulder pain,~     headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying~     on shoulder in patients undergoing total laparoscopic hysterectomy.~   "
92568|NCT01845519|"~     This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm~     randomized walking intervention. All intervention materials will be delivered~     electronically.~      The investigators hypothesize that at the end of 12-weeks, participants randomized to the~     intervention group will engage in more weekly steps than those participants randomized to~     the comparison group.~   "
92569|NCT01845506|"~     The primary outcome for this project will be the development of a small, non-invasive~     wireless sensor that is linked to a conventional computer that can be used in health care~     for monitoring of acute and chronic health problems. The advantages of developing this~     technology are threefold. First, monitoring can be conducted for a fraction of the cost of a~     bedside nurse. Second, monitoring can be done in real time and stored so that we can~     diagnose and manage critical events in a more timely manner. Lastly, many patients can be~     monitored simultaneously. The wireless sensors will be fitted to healthy volunteers of~     various ages. The data gathered from the sensor with respect to their vital signs will be~     compared to that of conventional tools such as nursing assessments and pulse oximetry.~   "
92570|NCT01845493|"~     The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN)~     for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is~     possible with this supplementation regimen in individuals with allergic asthma.~   "
92571|NCT01845480|"~     Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads,~     and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited~     participants will be randomly assigned to either healthful eating and physical activity~     skills coaching or general health education coaching intervention conditions. For both~     conditions, research assistants will serve as wellness coaches and deliver 12 intervention~     sessions in the home of each participating child.~      Assessments will be completed at baseline, intervention end (3 months), and follow-up (6~     months), comprising biomedical and psychosocial measures. Biomedical measurements to be~     obtained include:~        -  body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)~        -  blood pressure (automated sphygmomanometer),~        -  pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity,~          forced expiratory flow at 25-75% of vital capacity),~        -  unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,~        -  and physical activity levels (7-day accelerometry).~      Psychosocial measurements include:~        -  fruit and vegetable consumption (Child Dietary Questionnaire)~        -  self efficacy,~        -  enjoyment~        -  quality of life (Peds QL).~      Inclusion criteria are:~        -  being female~        -  aged 8-13 years~        -  with parental consent,~        -  residing within a 40-minute drive~        -  being available for 12 home coaching visits and three lab assessments.~      Exclusion criteria are~        -  having developmental delay or psychiatric problems,~        -  any illness, injury, condition, or disease that would prevent participation in~          moderate-to-vigorous physical activity,~        -  taking weight-altering medications~        -  participating in any other health behavior change program.~      The objectives of this study are to determine~        -  whether both types of the home-based coaching interventions are feasible~        -  whether the healthful eating and physical activity skills coaching intervention is more~          efficacious, relative to the general health education coaching group, in preventing~          increases in body fat percentage, body mass index percentile, waist circumference,~          systolic and diastolic blood pressure, and sedentary behavior~        -  whether the healthful eating and physical activity skills coaching intervention is more~          efficacious, relative to the general health education coaching group, in facilitating~          increases in quality of life, moderate-to-vigorous physical activity, enjoyment of~          physical activity and fruit and vegetable consumption, and self-efficacy for physical~          activity and fruit and vegetable consumption.~      We hypothesize that the research project will be successful in recruiting and retaining~     participating families, training research assistants to deliver the intervention components,~     and that both of the coaching conditions will be well received and appreciated by~     participating families. We hypothesize that the healthful eating and physical activity~     skills coaching intervention will be more effective than the support coaching condition in~     preventing increases in blood pressure, airway dysfunction and adiposity. We expect that~     both intervention conditions will show improvements to pediatric quality of life measures,~     but that the healthful eating and physical activity skills coaching intervention will be~     more effective than general health education coaching condition in increasing physical~     activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption,~     and fruit and vegetable enjoyment and self-efficacy.~   "
92572|NCT01845467|"~     BACKGROUND:~      Auto immune pancreatitis (AIP), a benign pancreatic disease has certain morphological forms~     which mimics pancreatic malignancy in radiological appearance. There is no singe diagnostic~     test which can accurately differentiate these two conditions. In the past, AIP accounted for~     up to 27% of Whipple resections performed for suspected adenocarcinoma.~      AIMS:~      To evaluate the efficacy of Secretin assisted Magnetic resonance cholangio pancreatography~     (MRCP) in differentiating AIP and pancreatic malignancy.~      METHODS:~      100 patients suspected with AIP will be consented to participate in the study to undergo~     secretin MRCP in addition to their other standard investigations. Patients will be~     categorized as those with AIP and with pancreatic malignancy based on these results and will~     be followed. Follow up will eventually give the true diagnosis when patients with pancreatic~     malignancy undergo pancreatic surgery and their pancreatic tissue is examined by~     histopathologist. AIP patients will undergo steroid trial which will give the true~     diagnosis. The preliminary diagnosis results based on standard investigations with and~     without inclusion of secretin MRCP will be compared to the true diagnosis.~   "
92573|NCT01845454|"~     The primary objective of this study is to determine the percentage segment regression after~     spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's~     Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended~     therapeutic range.~      Secondary objectives are the determination of safety related outcomes such as esophageal~     stricture.~   "
92574|NCT01845441|"~     Dexmedetomidine is a unique sedative medication able to provide sedation without causing~     respiratory depression and maintaining neurological functions. Patients having an acute~     ischemic stroke and need to undergo endovascular therapy require constant assessment of~     their neurological status prior, during and after the interventional procedure. In this~     study the investigators will compare the efficacy of Dexmedetomidine to other standard~     sedative medications in providing optimal sedative effect while maintaining neurological~     function.~   "
92575|NCT01845428|"~     The purpose of this research study is to learn if using statin in patients with nephrotic~     syndrome could lower the risk of blood clots. Nephrotic syndrome is a collection of signs~     and symptoms that occur when the glomeruli -the tiny filters that work in the kidney- leak~     protein in the urine.~      One of the symptoms associated with nephrotic syndrome is hyperlipidemia: too much bad~     cholesterol (LDL). This bad cholesterol could be linked to the increased risk of blood clots~     in patients with nephrotic syndrome. The study doctors would like to see if taking a statin~     drug to reduce the amount of bad cholesterol could reduce the risk of blood clots.~   "
92576|NCT01845415|"~     Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the~     developed and implementation of a social marketing intervention campaign aimed at lowering~     the incidence of falls to children in the home; City of Hamilton - Public Health Services~     (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public~     Health, Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This~     campaign is based on community-based intervention research and 'best practices' for~     improving parent attitudes and behaviours toward child safety. The campaign will focus on~     increasing parents' awareness and knowledge of fall injuries, positively impact parental~     attitudes to motivate them to want to implement strategies to reduce fall risks, and~     increase parental safety practices that would counteract the most common mechanisms that~     contribute to home falls for children at these young ages. The campaign will run from~     September 2013 through August 2014. The PHUs' social marketing campaign will strategically~     disseminate different materials to their respective communities: printed materials (posters,~     pamphlets), video modules about parenting safety, safety information through an e-Health~     website, and direction communication with parents through Family Health Team practitioners.~      The proposed research project will request archival data from Canadian Institute of Health~     Information (CIHI), specifically from their National Ambulatory Care Reporting System~     (NACRS), on frequency of falls in the home to determine the extent to which the social~     marketing campaign is effective. Comparing pre-, during and post-intervention levels in the~     PHU communities will determine if and which social marketing strategies were effective.~     Additionally, random digit dialing will be used to assess pre vs post parental fall related~     attitudes, behaviors and intervention exposure. This evaluation will provide the first ever~     test of a community level intervention to reduce childhood falls in the home in Canada and~     will provide valuable information about what constitutes 'best practices' for preventing~     falls in the home among children 1 through 4 years of age.~   "
92577|NCT01845402|"~     The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is~     not known, but there is evidence of CKD in young adults. In the present study assumption is~     made that CKD can already by diagnosed in patients at or just before adolescence, and the~     aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study,~     which will enroll patients aged 10 to 15 years. The second hypothesis is that events~     occurring peri-operatively during initial surgery or during follow-up could by chart review~     and regression analysis.~   "
92578|NCT01845389|"~     Geriatric patients have a significantly higher incidence of morbidity and morality during~     surgery compared with younger age group. Transurethral resection of the prostate (TURP) is~     the gold standard treatment for elderly patients with bladder outlet obstruction. Thus~     Regional techniques may be better tolerated in the elderly patients undergoing TURP having~     the advantages of minimizing blood loss and thromboembolic events. The Wiley Spinal™~     (Epimed; Johnstown, NY) catheter is an innovative flexible cannula over needle designed for~     convenient intrathecal access that reduces PDPH. We hypothesized that using less anesthetics~     during continuous spinal anesthesia with the Wiley spinal catheter would offer more~     hemodynamic stability with less side effects when compared with continuous epidural~     anesthesia in patients undergoing TURP~   "
92579|NCT01845376|"~     This present randomized trial is designed to evaluate the postoperative pain,inflammatory~     marker, postoperative analgesic medication, length of hospital stay and the modifications of~     inflammatory mediators in patients undergoing inguinal hernia repair using local, spinal or~     general anesthesia.~   "
92580|NCT01845363|"~     Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented~     with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at~     the beginning and end of surgery, were analyzed using high performance liquid~     chromatography.~      Some published studies suggest that the dose of 2g does not supply the minimum inhibitory~     concentration for principal causal agents of surgical site infection.~      To determine the concentration of Cefazolin in adipose tissue of patients undergoing~     bariatric surgery and to evaluate the relationship between concentrations obtained and body~     mass index (BMI).~   "
92581|NCT01845350|"~     The purpose of this study is to determine whether M2 macrophages are safe and feasible in~     the treatment of non-acute stroke patients~   "
92649|NCT01844466|"~     This is a prospective study of patients with stroke with accompanying motor and visual~     deficits. There will be patients' evaluations at 2 time points at the acute and subacute~     period after the stroke. Statistical correlation of the improvement of their deficits will~     be conducted~   "
92582|NCT01845337|"~     Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and~     stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems~     including heart attacks. An alternative drug, called teysuno is used extensively in other~     countries instead of capecitabine and appears to have less of a bad effect on the heart~     whilst still killing cancer cells. This study will investigate the effect of these two drugs~     on the heart and blood vessels and will be the first of its kind in humans.~   "
92583|NCT01845324|"~     The investigators asume that the measurement of the fetal heart interventricular septum can~     serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus.~     The investigators will measure the septum width in patients with Diabetes and will correlate~     to standard measurements of the glucuse levels.~   "
92584|NCT01845311|"~     The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2~     Bioresorbable Coronary Scaffold in native coronary arteries.~   "
92585|NCT01845298|"~     The investigators' objective is to describe the variability of rifampicin absorption,~     markers of inflammation and gut damage, intestinal absorptive capacity, and intestinal~     permeability among HIV-infected volunteers. Rifampicin is the least well absorbed of the~     first-line anti-tuberculosis drugs. Rifampicin malabsorption is frequently observed in~     HIV-infected patients with active tuberculosis, but cannot be predicted by patient factors~     such as CD4+ T cell count, viral load, or the presence of diarrhea. The mechanisms for~     rifampicin malabsorption in HIV-infected patients are unknown. An understanding of~     mechanisms for rifampicin malabsorption could eventually lead to new therapeutic targets,~     with the ultimate goal of improving HIV/tuberculosis treatment outcomes.~   "
92586|NCT01845285|"~     The purpose of this postmarket Registry is to assess the standard of care and clinical~     outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical~     routine according to the approved commercial indications. Procedures and assessments~     required by this registry are generally considered standard of care for Transcatheter Aortic~     Valve Replacement patients.~      Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical~     performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and~     angiographic imaging.~   "
92587|NCT01845272|"~     This study is designated to evaluate the pharmacokinetic interactions of candesartan~     cilexetil and amlodipine besylate in healthy male volunteers.~   "
92588|NCT01845259|"~     Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major~     clinical problems among antipsychotic-treated patients. Especially two of the most~     efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic~     disturbances and can rarely be replaced by other drugs due to the effectiveness of the~     compounds. Glucagon-like peptide 1 (GLP-1) has improved glycemic control among patients with~     type 2 diabetes. The study will investigate whether the beneficial effects of GLP-1~     analogues on glycemic control in type 2 diabetic patients, can be extended to a population~     of non-diabetic, dysglycemic psychiatric patients, receiving antipsychotic medical~     treatment.~   "
92589|NCT01845246|"~     Objectives: Main objective: to assess the impact of an intervention for optimizing the~     dosing of colistin based on its plasma levels in patients with infections due to multi-drug~     resistant gram negative bacilli. The impact will be evaluated in terms of clinical and~     microbiological outcome, and toxicity.~      Secondary objectives:~        1. To determine the percentage of patients reaching plasma levels considered adequate~          (Cmax / MIC 8-10) for the treatment of infections due to gram-negative bacilli~          susceptible to colistin, in the cohort of patients treated with standard doses of this~          drug without adjusting the dose.~        2. To analyze the possible emergence of bacterial resistance to this drug and its~          relationship to the calculated colistin pharmacokinetic and pharmacodynamic indexes.~      Methods:~      Design: open controlled trial, blinded for the analyst, to be performed at thre tertiary~     care Hospitals in Barcelona.~      Subjects: Patients attended consecutively between 2012 and 2013 infected with multi-drug~     resistant gram negative bacilli and treated with colistin.~      Sample size: 142 cases. Intervention: Once detected the infection requiring treatment with~     colistin, patients will be randomized to receive the intervention or not, with a 1:1 ratio.~     The intervention will be performed by an Infectious Diseases physician and will consist in a~     recommendation on the dose of colistin based on its plasma levels 48 hours after treatment~     onset.~      Variables: peak and through colistin levels 48 hours after treatment onset, clinical,~     analytical and microbiological data at baseline and during follow-up of the patients.~      Outcome measures: clinical, microbiological and toxicity data. Analysis: Comparison of~     patient characteristics and outcome variables between patients who had received the~     intervention and those who had not. The analysis will be done by intention to treat, by~     biological effectiveness and by compliance with the protocol.~   "
92590|NCT01845233|"~     The purpose of this study is to determine whether clinical examination, report from~     ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as~     screening tools to reveal clinical relevant problems with patients receiving long term~     treatment with non invasive ventilation.~   "
92591|NCT01845220|"~     This study is designed to determine whether Asians who are especially sensitive to alcohol~     exposure can be protected by boosting their activities of an alcohol disposing enzyme. This~     will be accomplished by administering broccoli sprouts that are rich in an agent that~     increases protective enzyme activity. The test system involves applying alcohol patches to~     the skin and measuring skin redness.~   "
92592|NCT01845207|"~     Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several~     tools exist to measure frailty, some based on physical tests and others on questionnaires,~     yet there is no agreement on which tool to recommend. This multi-center prospective cohort~     study is aimed at comparing various frailty assessment tools to determine which best~     predicts death or major complications after cardiac surgery or transcatheter intervention.~     The population of interest is elderly patients with severe aortic stenosis undergoing~     surgical or transcatheter aortic valve replacement. The frailty assessment tools under~     investigation include composite frailty scales, physical performance tests, muscle mass, and~     biomarker expression. The overall objective is to improve our ability to predict risk by~     measuring frailty using the optimal tool in elderly cardiovascular patients.~   "
92593|NCT01845194|"~     This human pharmacokinetic study investigates, whether processes of drug metabolism and~     transport are determined by genetic or hereditary factors. Therefore, approved drugs are~     applied to twins and metabolism and transport processes are investigated.~   "
92660|NCT01844323|"~     The particle size of the active ingredient may impact dissolution rate in the gastro~     intestinal tract and hence the amount of drug available for absorption. Similarly,~     differences in the percentage of the excipients used in the formulated capsules may affect~     dissolution rate. The purpose of this study is to estimate the effect that particle size and~     percentage of excipients could have in drug absorption, which will improve the manufacturing~     process of the formulated capsules.~   "
92661|NCT01844310|"~     This study is to evaluate the safety and efficacy of RAL-based regimen in~     treatment-experienced patients with resistant HIV infection~   "
92594|NCT01845181|"~     This is a phase I, single-center, randomized, double-blind, dose escalation study without~     therapeutic benefit, in which PBF-680 will be administered as single oral ascending dose to~     young male healthy volunteers. Up to four different rising doses will be tested in groups of~     8 participants. Thus, four groups will participate but each one participating only once. For~     each dose level / group the participants will be randomized to active or placebo with 2~     participants being randomly assigned to placebo and 6 to the active drug. First, one~     volunteer will receive active drug (subgroup 1); after 48h of safety and tolerability~     assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after~     48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will~     receive 3 active drug and 1 placebo. After evaluation of safety parameters of dose level the~     process will replicate one week afterwards in the following dosages.~      The aims of this study are:~      Primary:~      - To assess the safety and tolerability of single escalating oral doses of PBF-680 in young~     male healthy subjects leading to the determination of the maximum tolerated dose (MTD).~      Secondary:~        -  To assess the pharmacokinetics of PBF-680 after single rising oral doses in healthy~          young male subjects.~        -  To asses the preliminary pharmacodynamic effects.~        -  To evaluate the adenosine A1 receptor antagonism in blood samples of healthy volunteer~          caused by the PBF-680 administration~   "
92595|NCT01845168|"~     The purpose of this study is to investigate if a computerised decision-support tool used in~     general practice, can reduce the frequency of peptic ulcer bleeding related to the use of~     NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .~      On the basis of The Danish general medical database it is possible to develope a~     computerised decision-support tool, which enables the general practitioner (GP) in a~     pop-up window to get information on each patients risk-factors, when prescribing NSAID and~     aspirin to a patient at risk. This will give the general practitioner the oppurtunity to~     choose a different type of preparation or prescribe ulcer-preventive medicine at the same~     time.~      The decision-support tool will be tested in a randomized trial among general practitioners.~     The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a~     reduction in half of the total numbers of peptic ulcers.~   "
92596|NCT01845155|"~     BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the~     sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a~     variety of treatments, many patients with chronic tinnitus ask for more active ways in~     coping with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive~     directive counseling explaining the underlying mechanisms leading to the tinnitus percept.~     Therefore a neuro-music therapeutic treatment based on a bio-psycho-social framework was~     developed and compared to a counselling-only control group.~      INTERVENTION: two standardized protocols for tinnitus therapy were defined (neuro-music~     therapy vs. counselling)~   "
92597|NCT01845142|"~     Vitamin D receptors are expressed in activated different immune cells. It is not known,~     which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient~     individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous~     in a double-blind placebo controlled setting. Immune cells will be monitored from the blood~     over time.~   "
92598|NCT01845129|"~     The present study assesses whether language functions in patients with residual post-stroke~     aphasia can be improved by transcranial direct current stimulation administered to the~     primary motor cortex in the language dominant (left) hemisphere.~   "
92599|NCT01845116|"~     The purpose of this study is to determine whether the omega-3 fatty acid emulsion~     (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is~     effective in treating parenteral nutrition associated liver disease (PNALD) in children.~      The study hypothesis is that Omegaven® can be safely provided to children who are dependent~     on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD~     until the child can take adequate nutrition by mouth.~   "
92600|NCT01845103|"~     This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery~     System. The purpose of this study is to demonstrate that the 30 day mortality rate among~     patients who are treated with this device is less than the historical rate plus a~     non-inferiority margin.~   "
92601|NCT01845090|"~     To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in~     hemodialysis patients.~   "
92602|NCT01845077|"~     The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed~     fixed dose combination (FDC) tablets containing linagliptin & metformin and the single~     tablets of linagliptin and metformin when administered singularly.~   "
92603|NCT01845064|"~     DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may~     eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time~     that this compound is being given to humans.~      The purpose of the study is to investigate to what extent DM199 is safe and tolerated.~     Further, it will be investigated how quickly and to what extent DM99 is absorbed and~     eliminated from the body (this is called pharmacokinetics). In addition, the effect of the~     compound on the body will be investigated (this is called pharmacodynamics).~      This study is not intended to improve anyone's health, but is necessary for the further~     development of DM199.~      The study consists of 4 parts. Each part (A, B, C and D) will consist of one or several~     periods. The research will be conducted in healthy male and female volunteers (Part A and C)~     and in male and female type 2 diabetes mellitus patients (Part B and D).~   "
92604|NCT01845051|"~     The researchers investigated the relationship between migraine and allergy. For this~     purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs;~     and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy~     subjects. According to these results the prevalence of allergic rhinitis in migraine group~     was planned to be compared to that of the healthy controls, statistically.~   "
92605|NCT01845038|"~     The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug~     product, when placed in the canaliculus of the eyelid compares to timolol drops for the~     lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular~     hypertension.~   "
92662|NCT01844297|"~     This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil~     fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy~     (ART)-naive Chinese HIV/AIDS patients.~   "
92607|NCT01845012|"~     HDQ 200 is an interventional multicenter study. This is a before-and-after design in which~     the patient is his own control. The main objective of the study is to determine the~     percentage of success of a procedure of daily hemodialysis at low dialysate flow. All~     patients treated with conventional hemodialysis, for at least 3 months and clinically~     stable, can be included in the study. Their 3 months data prior to inclusion is collected~     retrospectively. These 3 months of conventional hemodialysis are the reference period.~     Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During~     this 3 months period, the same data as during the period of conventional hemodialysis are~     collected prospectively.~   "
92608|NCT01844999|"~     The purpose of this study is to determine whether using the P3P website can increase~     decisional preparation and satisfaction, and decrease decisional conflict, in men deciding~     how to manage early stage prostate cancer.~   "
92609|NCT01844986|"~     Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line~     Platinum Based Chemotherapy.~   "
92610|NCT01844973|"~     This study is to evaluate the pharmacokinetics and safety of M518101 in male and female~     plaque psoriasis patients.~   "
92611|NCT01844960|"~     A double blinded randomised control trial comparing the differences between laparoscopic~     single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35).~     Single incision surgery is a new minimally invasive surgical technique requiring the surgeon~     to operate through one small single incision and is virtually scarless. The traditional~     laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports)~     across the whole abdomen. This study seeks to identify the risks, benefits and costs of the~     adjustable gastric band insertion via single incision and multiple incision within the~     morbidly obese patient group.~   "
92612|NCT01844947|"~     This study aims to analyse the tolerability (side effects and safety) with standard~     treatment (Javlor®) with the addition of a second anti-tumour drug: sorafenib (Nexavar®).~     This is the first time this treatment combination is studied in humans. Samples of blood,~     urine and tumour tissues will be analysed for molecular biomarkers. These biomarkers may~     potentially help us in the future in predicting whether a patient will benefit or not from~     the cancer treatment. The study also aims to investigate if a newer imaging method, called~     PET-CT (positron emission tomography-computed tomography), at an earlier stage (than a~     normal CT scan) can identify patients who will benefit from the given treatment.~   "
92613|NCT01844934|"~     A study comparing the benefits of pre-habilitation exercise to standard care prior to total~     knee arthroplasy~   "
92614|NCT01844921|"~     This is a single center, single arm, open label observational trial of patients undergoing~     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians~     to position the NvisionVLE catheter to acquire an image of an area of the esophagus to~     identify and discriminate abnormal areas of tissue from normal.~   "
92615|NCT01844908|"~     Postoperative ileus remains a significant medical problem after colorectal surgery that~     adversely influences patients' recovery. The investigators previous study demonstrated that~     electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of~     postoperative ileus and hospital stay after laparoscopic resection of colonic and upper~     rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal~     excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex~     cases are more likely to develop prolonged ileus and morbidity after surgery, and it is~     uncertain whether EA will be beneficial to them. The investigators therefore propose to~     conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged~     ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with~     mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will~     be recruited. All patients will undergo 1 session (20 minutes) of EA daily from~     postoperative day 1 till day 4. These patients will be compared with a matched historical~     control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is~     the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet~     by 4 days after surgery, associated with the need for nasogastric decompression and/or~     parenteral nutrition support. Secondary outcomes include time to defecation and duration of~     hospital stay. Results of this study will help clarify the efficacy of EA in preventing~     prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a~     larger randomized controlled trial.~   "
92616|NCT01844895|"~     The purpose of this study is to implement a substudy in approximately 120 rheumatoid~     arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss),~     Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC)~     Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled~     syringe.~   "
92617|NCT01844882|"~     Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline~     of renal function associated with increased overall mortality. Most dietary guidelines for~     CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods.~     However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion~     which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review~     and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as~     classical markers of a state of uremia in individuals with CKD. We hypothesize that~     increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.~   "
92618|NCT01844869|"~     The purpose of this study is to determine the pharmacokinetic and safety profiles of~     omacetaxine and its metabolites in patients with relapsed and/or refractory hematologic~     malignancies or advanced solid tumors following subcutaneous (sc) administration.~   "
92619|NCT01844856|"~     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in~     the treatment of adult complicated intra-abdominal infections (cIAI).~   "
92663|NCT01844284|"~     Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter,~     Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in~     the treatment of subjects with ischemic heart disease caused by de novo native coronary~     artery lesions in Japanese population by comparing to approved metallic drug eluting stent.~   "
92620|NCT01844843|"~     Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES),~     coverage of the stent struts by new tissue. The evaluation will be performed by means of~     intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue~     coverage over the implanted stent struts prevents direct contact between blood and~     metal/polymer, which could lead to adverse events: patients need to take blood-thinning~     drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the~     stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months.~     This should allow fast coverage of the struts, and might allow to reduce duration of the~     supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at~     3 months after implantation, as assessed by OFDI.~   "
92621|NCT01844830|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for~     inducing pulpal anesthesia of the maxillary teeth in pediatric patients.~   "
92622|NCT01844817|"~     The purpose of this study is to compare the overall survival in patients with previously~     untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or~     gemcitabine/nab-paclitaxel plus placebo.~   "
92623|NCT01844804|"~     In this study, healthy volunteers will receive a single intravenous dose of either~     PF-06438179 or infliximab (United States) or infliximab (European Union). During the course~     of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the~     blood, and by comparing these levels among the different administration arms of PF-06438179~     and the licensed infliximab products. Safety, tolerability, and immunologic response will~     also be evaluated throughout.~   "
92624|NCT01844791|"~     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS~     in combination with Platinum-Gemcitabine based doublet first line therapy in stage IV~     non-small cell lung cancer (NSCLC) patients.~   "
92625|NCT01844778|"~     The purpose of this interventional Phase IV study was to explore the ease of use of TIP and~     prevalence of microbial contamination of the T-326 Inhaler compared with TIS and~     colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients~     chronically infected with P. aeruginosa.~      It was anticipated that the data from this study would provide clinicians with further~     guidance on the relative differences between the speed and ease of use of these treatments~     as well as useful information on the prevalence of microbial contamination of the inhalation~     devices in real world use.~   "
92626|NCT01844765|"~     To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic~     myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).~   "
92627|NCT01844752|"~     This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized~     to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and~     efficacy will be assessed over the course of the study.~   "
92628|NCT01844739|"~     This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with~     elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or~     Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability,~     safety, and P. acnes counts.~   "
92629|NCT01844726|"~     The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13,~     an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness~     on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.~   "
92630|NCT01844713|"~     This study is being done to evaluate the effectiveness of a Sun Protection Strategies~     workbook for kidney transplant recipients. Since the medication taken to preserve the kidney~     transplant puts kidney transplant recipients at an increased risk of developing skin cancer.~     The program will help people learn about how to practice effective sun protection after the~     transplant.~   "
92631|NCT01844700|"~     We will conduct a 12-week, randomized open label study, comparing usual care (UC)~     antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in~     children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime~     antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric~     psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania,~     schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In~     addition, we will also include youth fulfilling research diagnostic criteria for severe mood~     dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for~     antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be~     weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each~     of the two genotype groups. As detailed below, other metabolic and cardiac safety parameters~     will also be measured and compared across treatments in each of the genotype groups.~   "
92632|NCT01844687|"~     The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,~     800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and~     cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when~     combined with placebo marijuana, as well as its ability to modulate the behavioral effects~     of active marijuana.~   "
92633|NCT01844674|"~     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of~     multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of~     tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies.~     Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally~     twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants~     will have the option to continue treatment with vemurafenib as part of an extension study~     (NCT01739764).~   "
92634|NCT01844661|"~     The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children~     and adults with metastatic and refractory solid tumors. CELYVIR consists in bone~     marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic~     adenovirus. In addition to data on toxicities the investigators will evaluate clinical~     response.~   "
92635|NCT01844648|"~     To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving~     muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients~     manifesting sialorrhea complaints.~   "
95318|NCT01809483|"~     This research aims to compare between bandage contact lens and pressure patching in reducing~     size of erosion area and pain scale in corneal erosion patients as well as its~     complications.~   "
92636|NCT01844635|"~     The objective of this study is to evaluate the feasibility and effectiveness of~     immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline,~     Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia~     (SAA) as a primary therapy. The primary endpoint is the response rate (complete response~     (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include~     evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and~     EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and~     CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST,~     relapse rate and overall survival.~   "
92637|NCT01844622|"~     The purpose of the study is to treat patients with on-going slow stomach~     emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy~   "
92638|NCT01844609|"~     The purpose of this study is to determine if an intensive journal club based on articles and~     materials provided on the journal Obstetrics and Gynecology Website improves written and~     spoken comprehension of medical English in a population of Chinese medical professionals.~   "
92639|NCT01844596|"~     Cardiovascular disease (CVD) is the leading cause of death in sub-Saharan Africa among~     adults above age 30. The prevalence of hypertension, a major risk factor for CVD, is~     increasing over time in sub-Saharan Africa, exerting a significant epidemiologic and~     economic burden on the region. Without adequate control of hypertension, its health and~     economic burden will increase drastically in the decades ahead. Well established and~     evidence-based interventions to manage hypertension exist; however, treatment and control~     rates are low.~      A critical component of hypertension management is to facilitate sustained access of~     affected individuals to effective clinical services. In partnership with the Government of~     Kenya, the United States Agency for International Development-Academic Model Providing~     Access to Healthcare Partnership (AMPATH) is expanding its clinical scope of work in rural~     western Kenya to include hypertension and other chronic diseases.~      However, linking and retaining individuals with elevated blood pressure to the clinical care~     program has been difficult. Thus, the overall objective of this application is to utilize a~     multi-disciplinary implementation research approach to address the challenge of linking and~     retaining hypertensive individuals to a hypertension management program. We aim to add to~     existing knowledge on scalable and sustainable strategies for optimizing control of~     hypertension and other chronic diseases in low- and middle-income countries.~   "
92640|NCT01844583|"~     Safety, tolerability and PK of concomitant esomeprazole and rifampin, and QT study on single~     and multiple-doses of alisertib~   "
92641|NCT01844570|"~     The purpose of this study is to determine whether the effectiveness of levamlodipine maleate~     (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a~     Chinese primary hypertension population.~   "
92642|NCT01844557|"~     The goal of this research study is to look for factors that influence whether or not head~     and neck cancer patients follow the swallowing exercises that they are asked to perform~     while receiving radiation treatment.~   "
92643|NCT01844544|"~     the purpose of the study is to:~        1. Identify and characterize drug related problems in patients after a femur neck fracture~          that are hospitalized in the orthopedic department at Meir medical center.~        2. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and~          preventing drug related problems in patients after a femur neck fracture that are~          hospitalized in the orthopedic department at Meir medical center.~   "
92644|NCT01844531|"~     The primary objective of this trial is to establish bioequivalence of two fixed dose~     combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1]~     and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose~     empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin~     tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high~     fat, high caloric meal.~      The assessment of safety and tolerability will be an additional objective of this trial.~   "
92645|NCT01844518|"~     The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)~     at Day 113 in children and adolescents with pJIA~   "
92646|NCT01844505|"~     The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with~     Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab~     alone.~   "
92647|NCT01844492|"~     One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care~     unit (ICU), typically following decisions made by surrogate decision makers to forego life~     prolonging treatment. A large body of empirical research has identified deficiencies in care~     processes that contribute to three important problems: 1) family members often struggle in~     the role of surrogate, 2)leading to lasting psychological distress associated with the ICU~     experience patients near the end of life frequently receive invasive, expensive treatment~     that is inconsistent with their values and preferences, and 3) end-of-life care is a major~     contributor to health care costs.[8, 9] Although advance care planning can prevent some~     unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis~     is uncertain, and therefore it seems likely that the need for interventions to improve~     in-the-moment decisions by surrogates will persist.[10, 11]~      The long term goal of the investigators research program is to develop, test, and~     disseminate strategies to improve surrogate decision making for incapacitated patients and~     to mitigate adverse psychological outcomes among surrogates. In a pilot project, the~     investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with~     Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention~     that 1) gives new responsibilities and advanced communication skills training to existing~     ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care~     defaults to ensure frequent clinician-family meetings; 3) adds protocolized,~     nurse-administered coaching and emotional support of surrogates before and during~     clinician-family meetings, and 4) increases use of palliative care services for patients~     with a poor prognosis. The investigators 2-year pilot study documented that the intervention~     is feasible, sustainable, and is associated with shorter ICU length of stay and cost~     savings. The objective of this proposal, which is the next step in pursuit of the long term~     goal, is to conduct a stepped wedge randomized controlled trial testing the PARTNER~     intervention in 5 ICUs among 1000 patients with advanced critical illness and their~     surrogates.~   "
92648|NCT01844479|"~     In this pilot study, the first objective is to bench test a novel shear reducing insole and~     compare it to current standard insoles and shoes. The second objective is to study~     twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for~     changes in spatial temporal gait including gait initiation, risk of falling, static and~     dynamic balance, and plantar temperature response to walking and consecutive plantar stress~     in both footwear conditions.~   "
95544|NCT01806532|"~     The goal of this study is to investigate acute respiratory distress syndrome (ARDS) with~     positron emission tomography (PET) imaging and to examine the distribution of inflammation,~     as measured by neutrophil metabolic activity.~   "
92650|NCT01844453|"~     The application of in-vitro fertilization (IVF) has provided remarkable opportunities for~     infertile couple to conceive in the last four decades. Historically IVF was performed for~     patients with bilateral tubal obstruction, but its use is presently widespread. Although the~     efficacy of assisted reproductive technology continues to improve, endometrial implantation~     remains the limiting step towards a successful pregnancy. Reduced endometrial receptivity~     and embryonic defects are the probable primary causes of implantation failure during IVF(1).~     Patients with repeated implantation failure despite transferring good-quality embryos~     continue to be a major dilemma for clinicians and are a topic of great research interest.~     Barash et al. unintentionally discovered and initially reported that an endometrial biopsy~     prior to IVF in women who have had one or more implantation failures was associated with an~     increased clinical pregnancy (66.7% vs 30.3%, p<0.01) and live birth rates 48.9% vs 22.5%,~     p=0.02) compared to a control group(2). The mechanism by which a local endometrial injury~     (LEI) may increase the pregnancy rate is still not fully clear. Possible etiologies include~     its role in promoting a beneficial local inflammatory response, inducing endometrial~     decidualization, or improving endometrial maturation synchrony (3-6).~      Following Barash et al's publication, several randomized controlled studies confirmed their~     findings (7-11). However, there has been extensive heterogeneity among studies, including~     the number of biopsies, how the biopsy is performed and the selected patient population. On~     the other hand all the studies have in common that the endometrial biopsy was performed~     prior to the start of the IVF cycle.~      The optimal timing of an endometrial biopsy with respect to an IVF cycle is unknown. There~     is reason to suspect that an endometrial biopsy during the follicular phase of an IVF~     stimulation cycle may improve pregnancy outcomes, although this has not been directly~     examined. We therefore propose a randomized controlled study to evaluate the impact of an~     endometrial biopsy on the implantation and pregnancy rate in both the luteal phase prior to~     the IVF cycle as well as the follicular phase of the concurrent IVF cycles.~   "
92651|NCT01844440|"~     The aim of this study is to establish and validate High resolution manometry (HRM) criteria~     for the definition of transient lower esophageal sphincter relaxations (tLESRs) in~     gastroesophageal reflux disease (GERD) patients.~   "
92652|NCT01844427|"~     This is a 12-week clinical trial evaluating the efficacy and safety of memantine~     hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function~     deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After~     screening procedures, memantine is prescribed in randomized, double-blind fashion (equal~     chance of medication or placebo) for 12 weeks.~      The investigators hypothesize that memantine hydrochloride will prove to be an effective,~     safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested~     in non-stimulant medications.~   "
92653|NCT01844414|"~     The purpose of this study is to conduct a prospective, three-group study that randomly~     assigns 700 parolees, in a community residential drug treatment program, to enter one of~     three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which~     includes nurse case management and specialized hepatitis education sessions and the~     hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring~     (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone~     Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination~     and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes~     brief general health information, one-on-one coaching and the HAV/HBV vaccine.~   "
92654|NCT01844401|"~     The primary objective of this study is to compare the pharmacokinetic (PK) profiles of~     Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg~     albuterol base from each product.~   "
92655|NCT01844388|"~     This study will compare the safety and efficacy of a new carboxymethylcellulose based eye~     drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.~   "
92656|NCT01844375|"~     This prospective randomized controlled study is designed to investigate whether preoperative~     oral carbohydrate loading improves postoperative walking performance, a surrogate indicator~     for overall functional recovery, in patients undergoing colorectal surgery as measured by~     2-minute and 6-minute walk test. The secondary outcomes are postoperative insulin resistance~     measured with plasma insulin and glucose concentrations. The tertiary outcomes are duration~     of hospital stay, patients satisfaction during staying in the hospital and morbidity~     measured as postoperative complications.~   "
92657|NCT01844362|"~     Uterus transplantation, as a possible future treatment for uterine factor infertility, has~     been developed in animal species during the last decade.~      The study protocol includes transplantation of the uterus from a live donor (mother,~     relative, friend) into women with absolute uterine factor infertility (lack of uterus from~     birth or due to life saving hysterectomy).The recipient will be treated by standard~     immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted~     when at least 12 months have passed from transplantation. Approval for a case series~     including up to 10 patients has been acquired.~   "
92658|NCT01844349|"~     Problematic and state of the art Obesity and its associated non communicable diseases (NCDs)~     are rising rapidly in middle income countries, such as those in the Maghreb (North Africa).~     This progression is related to the context of a nutrition transition (changing food and~     physical activity environment) and profound changes in technological advances and in~     society. These societies and their health systems are insufficiently prepared for this~     evolution, which has enormous health and socioeconomic consequences. In the context of~     limited resources, the priority has been given on an international level to prevention. But~     several problems arise: - these countries are still confronted by undernutrition in terms of~     micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level~     and also individual level. Known as the 'double burden', this coexistence is relatively new~     and has been rarely documented until recently. Educational measures could be ineffective in~     a society where cultural norms do not recognise obesity and where changes in lifestyle are~     possibly not seen as acceptable. As well as information about citizen's knowledge of risk~     factors, data on their perceptions and attitudes are indispensable. Policies that involve~     changing the 'obesogenic' environment that individuals occupy is a priority.~      Objectives of the project Overall aim: to contribute to the development of preventive~     strategies for obesity and chronic NCDs in the context of a nutrition transition.~      Specific objectives: characterise the nature and size of the double burden~     (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of~     biological and behavioural risk factors; characterise the psycho-sociocultural determinants~     of behaviour.~   "
92659|NCT01844336|"~     The purpose of this study is to evaluate the performance of the PBASE system, in terms of~     the efficacy of treatment in patients with idiopathic rhinitis.~   "
92711|NCT01843660|"~     The purpose of this study is to evaluate the efficacy and safety of tramadol~     hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to~     severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to~     the bones) outpatient or emergency setting.~   "
92664|NCT01844271|"~     Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low~     Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and~     application parameters, mechanisms of action, effects on long-term exercise and the~     long-term effects on skeletal muscle recovery.~      The present research project aims to assess the effects of long-term recovery of LLLT in~     skeletal muscle after exercise and identify the optimal dose application of LLLT.~      After defining the best dose of application, we recruited two groups which will be~     irradiated with different power, 100mW and 400mW in order to seek the optimal parameter of~     low level laser therapy in performance.~      The investigators believed that the Low Level Laser Therapy can delay the physiological~     process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from~     physical effort and accelerate muscle recovery after exercise.~   "
92665|NCT01844258|"~     Pediatric cataract is totally different from adult cataract. There is traditionally no~     difference in technique between pediatric and adult cataract surgery. Opacification of the~     visual axis was the most frequent complication after pediatric surgery. In this clinical~     study, the investigators aimed to evaluate the safety and postoperative recovery of a~     modified technique for pediatric cataract surgery.~   "
92666|NCT01844245|"~     Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are~     suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary~     drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction.~     But restoration of bile flow have few improvement of the survival of cancer patient. By~     using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour~     growth, which might improve the survival of patients. The feasibility and safety of this~     technique using HabibTM EndoHBP probe has been evident. The aims of this randomised,~     controlled, multicentre study is to evaluate whether endobiliary radiofrequency~     ablation(RFA) can improve the median survival of patients with unresectable biliary~     malignancy.~   "
92667|NCT01844232|"~     Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled,~     dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release~     Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in~     this study will receive arbaclofen in the extended release tablet formulation.~   "
92668|NCT01844219|"~     Acute kidney injury after cardiac surgery has been reported to increase morbidity and~     mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac~     surgery have been developed. However, predictive accuracy of these models is stil unclear.~     The aim of this study is to evaluate the accuracy of four pre-existing prediction models~     using a gray zone approach in patients who underwent aortic surgery in our institution.~   "
92669|NCT01844206|"~     The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen~     for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes~     scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that~     administration of a second dose of epidural morphine 3 mg, 24 hours after an initial~     intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours~     after surgery, compared to a single epidural morphine dose regimen. The primary outcome will~     be the amount of intravenous morphine patients self-administer during the 2nd 24 hours~     post-surgery.~   "
92670|NCT01844193|"~     This study will examine the effects, if any, of using muscle stimulation on the quadriceps~     following a total knee replacement. Secondary objectives will be to evaluate and compare~     pain levels, qualitative outcomes, and the impact of NMES on pain medication requests~     between groups. It is possible that strengthening the quadriceps muscles and improving their~     activation will reduce postoperative pain and help patients return to activities sooner than~     with standard therapy alone.~   "
92671|NCT01844180|"~     The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in~     female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).~   "
92672|NCT01844167|"~     Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is~     time consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles~     C. Koo, is a unique electrical stimulation precisely on corresponding Noxipoints® of each~     injured soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve~     ending sensation. Each application typically last for 2 to 5 minutes. Based on observations~     of the clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder~     pain significantly with lasting effect, and effectively improves the range of motion.~     However, large-scale double-blinded, randomized control study on the therapy is not~     available yet.~      The purpose of this study is to compare the effect of Noxipoint® Therapy and physical~     therapy (including the current TENS application) on patients with chronic neck pain. This~     study is a prospective stratified randomized control trial. Eighty subjects with chronic~     cervical pain will be recruited from the Rehabilitation Department or the Physical Therapy~     Center of National Taiwan University Hospital (NTUH). The qualified subjects will be~     stratified and randomly allocated into two arms, 40 persons in each:~        1. Physical Therapy group (PT)~        2. Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6~          sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate~          after six sessions or earlier if the patient shows no symptoms.~      Subjects will be evaluated before and after the first treatment session and followed up at~     about 4 weeks, 8 weeks, and 12 weeks after the first treatment.~      Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of~     Motion (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life~     section in the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL~     measures will be taken before and after the first treatment session, and at 4 weeks, 8 weeks~     and 12 weeks after the first session. Elastogram will be taken before the first treatment,~     and about four weeks after the first treatment.~      Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing~     methods. All the estimated P-values are two tailed.~   "
92673|NCT01844154|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury or mortality. Identifying the~     factors related to falls occurring within this population is essential for the development~     of effective regimes for fall prevention. Studies have shown that muscle quality and good~     posture alignments are critical for balance control in older adults. People are diagnosed~     with osteoporosis often combining with muscles weakness, and increased spine kyphosis~     leading vertebral, fractures and poor balance control, even falls. Therefore, improving~     muscle quality, strengthening weak muscles and correcting postural alignment are essential~     elements for fracture and fall prevention in older adults with osteoporosis. The long-term~     objectives of this work are to prevent fracture and fall in older adults with osteoporosis~     by improving the function of degenerative muscles using exercise training.~   "
92674|NCT01844141|"~     To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70%~     alcohol in the surgical treatment of ingrown toenails.~   "
92712|NCT01843647|"~     The purpose of this study is to evaluate the overall response rate and disease free survival~     for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.~   "
92677|NCT01844102|"~     The study will measure the incidence of moderate and severe adverse events (AEs) associated~     with PrePex procedures among 500 men, including both procedural and post-procedure events,~     and all device-related incidents such as dislodgment. To assure complete ascertainment of~     AEs, study-specific forms will be used to collect standardized data from the circumcision~     visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and~     will transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.~   "
92678|NCT01844089|"~     The broad objective of the study is to determine if the Bakri Postpartum Balloon is~     effective in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of~     a standardized management algorithm.~      Specific Objectives~        -  To estimate the rate of morbidity (including operative intervention and peripartum~          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction~          of a standardized protocol for management of PPH, but prior to the inclusion of the~          Bakri Postpartum Balloon as part of the protocol.~        -  To estimate the rate of morbidity (including operative intervention and peripartum~          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction~          of a standardized protocol for management of PPH, after the inclusion of the Bakri~          Postpartum Balloon as part of the protocol.~        -  To compare morbidity~        -  To generate preliminary data for (a) a larger confirmatory study of the use of the~          Bakri Postpartum Balloon in centers with surgical and blood transfusion services, and~          (b) design of a pilot study of the use of the Bakri device of temporary control of PPH~          in settings outside of surgical centers (such as by trained midwives or emergency~          transport personnel).~   "
92679|NCT01844076|"~     Establish the tolerability and safety of aimed dose of both quinacrine and capecitabine in~     combination to treat patients with advanced colorectal adenocarcinoma.~   "
92680|NCT01844063|"~     HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with~     massive necrosis of liver cells. Liver transplantation might be the most effective therapy~     for HBV-LF. However, there are a lot of problems such as lack of donors, surgical~     complications, transplant rejection, and high cost, which could limit the application of~     liver transplantation. It is demonstrated that mesenchymal stem cells could directionally~     differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce~     inflammation of the liver by immune regulation. In this study, we assess the safety and~     efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for~     patients with HBV-LF.~   "
92681|NCT01844050|"~     Based on the Individualized treatment of diabetes symptoms to evaluate the method of~     syndrome differentiation treatment of Traditional Chinese medicine.~   "
92682|NCT01844037|"~     This is a multi-center, prospective registry designed to monitor the outcomes of renal~     denervation with the OneShot Device in a real-world patient population.~   "
92683|NCT01844024|"~     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per~     women. It is estimated that 56 percent of all pregnancies are unintended and the~     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and~     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and~     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units~     in Uganda due to unsafe abortion is reported and considered high in international~     comparison. Studies have revealed that trained midlevel providers can deliver safe post~     abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The~     prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the~     treatment of incomplete abortions. This option is so far under-used in developing countries,~     especially outside the larger hospitals and private clinics. One significant limiting factor~     in providing safe PAC is the lack of providers. So far technical training has been mainly~     limited to physicians. The long-term goal of this project is to provide evidence based~     information that will contribute to the development of strategies to increase women's access~     to high level post- abortion care at primary health care level provided by midlevel~     providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete~     abortion will increase access to safe PAC and is a key to Millenium Development Goal 5.~     Misoprostol treatment of incomplete abortion remains underused and in accessible to a~     majority of women in Uganda because national regulations restricts its prescription and~     supervision to doctors. However, the safety of misoprostol treatment should make it amenable~     to provision by midlevel providers. Training of midlevel providers in misoprostol treatment~     of incomplete abortion will support task shifting in places where doctors are costly and~     scarce. By evaluating the effectiveness of mid-level providers (midwives); administering~     misoprostol treatment of incomplete abortion the project is attempting to contribute to the~     reduction of maternal mortality and morbidity and safeguard high quality of post-abortion~     care. A direct economic impact can also be expected due to reduced treatment costs of~     complications from unsafely induced abortion and incomplete abortions. The involvement of~     midlevel providers in medical treatment of incomplete abortion has previously not been~     systematically evaluated in African primary health care setting.~   "
92684|NCT01844011|"~     The purpose of the study is to find out the best way to help pregnant women keep track of~     their baby's movements. During pregnancy, feeling your baby's movements is normal. A~     decrease in movement can indicate potential problems with your baby's well-being. This study~     will see if daily electronic reminders and kick count charts help women to better track~     their baby's movements over the last weeks of pregnancy.~   "
92685|NCT01843998|"~     The purpose of this study is to determine whether sirolimus reduces the symptoms of~     cutaneous T-cell lymphoma (CTCL) and whether it causes any side effects.~   "
92686|NCT01843985|"~     Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine~     whether they are candidates for traditional chemotherapy. If eligible, patients are offered~     traditional chemotherapy, low-dose chemotherapy, or palliative care. If ineligible, patients~     are offered low-dose chemotherapy or palliative care. Patients will be monitored for 5 years~     and survival data recorded.~   "
92687|NCT01843972|"~     To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single~     rising doses of BI 691751 in healthy male subjects (part I).~      To investigate the relative bioavailability of BI 691751 given as tablet versus oral~     solution (part II)~   "
92688|NCT01843959|"~     A cross-sectional study investigating the aetiology, mechanisms and associated complications~     contributing to obesity and diabetes within the UAE population. The study will be carried~     out in two main sample populations; children and adults, and characterized by the occurrence~     of obesity and diabetes. The main samples will then be divided into a subgroup for~     metabolomic analysis. Patients will be recruited from the Imperial College London Diabetes~     Centre. The study is aimed at elucidating the various factors that have an impact or may~     influence obesity and diabetes in the Emirati population.~   "
92689|NCT01843946|"~     Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia~     and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory~     diseases. To explore the potential therapeutic benefit of roxithromycin in chronic~     prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of~     roxithromycin with ciprofloxacin and aceclofenac.~   "
92690|NCT01843933|"~     Background: Due to the lingering effects of general anesthesia and the administration of~     medications for pain after surgery, children in the recovery room are at risk for breathing~     problems. While there are less data specific to children, in general 25% of patients in the~     recovery room experience complications from anesthesia. The most common complications~     involve the patient's airway and their ability to breath adequately. Currently, checks of~     oxygenation with a pulse oximetry monitor and of respiration through nursing assessments are~     used to detect breathing problems. However, these are believed not to be adequate for~     reliably recognizing significant respiratory depression until other dangerous events develop~     such as the cessation of breathing, severe drops in oxygen levels, or cardiac arrest.~     Capnography is a monitoring device that measures the amount of carbon dioxide being exhaled~     and assesses the adequacy of respiration. A small plastic cannula sits at the base of the~     nose and on the lip to continuously monitor the patient's breathing. Most children tolerate~     this device well and staff consider it easy to use. While capnography is routinely used in~     the operating room to monitor breathing, it is not used during post-operative care when~     patients are still at risk of breathing problems.~      Objectives: To determine if capnography can detect problems with breathing faster and more~     often than traditional monitors. To determine if the addition of capnography to routine~     monitoring will decrease the numbers of additional adverse events that occur in children~     undergoing post-operative care by allowing nurses to intervene in care faster and more~     frequently.~      Methods: In the first phase of this study, the investigators will apply the capnography~     monitor to children in the recover room and determine how often they experience breathing~     difficulties measured by this device. In the second phase, the investigators will educate~     staff on the use of capnography and what values are considered abnormal. Children will again~     have the capnography cannula placed on them as they enter the recovery room. They will then~     be divided into two groups - in one group the nurses in the recovery room will have access~     to the capnography monitor for their patients, whereas in the other group the nurses will~     not be able to see the readout from the monitor. The investigators will determine if~     children have fewer breathing problems and less additional adverse events when nurses use~     capnography in addition to the routine monitors already in place in the recovery room as~     compared to when nurses use standard monitoring alone.~      Potential Impact: If capnography can detect breathing problems prior to being identified by~     current monitoring devices, staff may be able to intervene more quickly and before more~     serious events occur in the children receiving post-operative care. This can reduce adverse~     events, improve patient safety, and avert harm in children. The adoption of this device for~     routine monitoring of post-operative care has the potential to save lives.~   "
92691|NCT01843920|"~     A controlled clinical study comparing the effect of topical aqueous suppressants on~     intraocular gas duration.~   "
92692|NCT01843907|"~     Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive~     interventions on readmission rates, loss of functions, quality of life and cost-benefit.~   "
92693|NCT01843894|"~     Objectives:~      Primary~        -  To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in~          patients with severe dry eye~      Secondary~        -  To explore the efficacy of RU-101~        -  To explore optimal endpoints for future studies~   "
92694|NCT01843881|"~     The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can~     affect insulin secretion after meals. The hypothesis of this study is the Disposition Index~     is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by~     glucagon-like peptide-1 (GLP-1) receptor blockade.~   "
92695|NCT01843868|"~     The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients~     receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The~     contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear.~      This study aims to evaluate the overall effectiveness of antiemetic control using a~     standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron)~     in a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin~     Vincristine Cyclophosphamide Prednisolone).~   "
92696|NCT01843855|"~     The study is being undertaken to understand how a gastric bypass can affect a subject's~     diabetes even prior to their losing significant amounts of weight. The hypothesis of this~     study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration~     in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.~   "
92697|NCT01843842|"~     The purpose of this study is:~        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper~          respiratory tract infections in children;~        -  to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment~          acute upper respiratory tract infections in children.~   "
92698|NCT01843829|"~     About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less~     than a quarter have resectable disease at diagnosis. There is a general lack of consistency~     in the standard of care for patients across UK hospitals. Patients are either treated with~     a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed~     by removal of the tumour by surgery, as part of their standard of care. Recent research~     supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the~     tumour and preventing the disease from spreading than taking chemotherapy alone. However,~     there is no definitive way of identifying which treatment is best without a clinical trial.~      Evidence suggests that the effect of the chemoradiotherapy currently used as standard~     practice may be improved and the side effects reduced by using a different chemoradiotherapy~     combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy~     before being randomised to receive two different chemoradiotherapy regimens (carboplatin and~     paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results~     in previous studies. Patients will then have their tumour removed. The best~     chemoradiotherapy regimen will then be taken forward to a Phase III trial in which~     chemoradiotherapy will be compared with chemotherapy alone.~      The efficacy of the regimens will be measured by counting the number of patients who i)~     remain free from cancer, ii)have local or distant spread of their cancer, iii) are~     successfully recruited and iv) experience toxicities. A specific set of toxicity criteria~     will be used to monitor any treatment induced side-effects and provide justification for any~     necessary dose modifications or withdrawal of treatment.~   "
92699|NCT01843816|"~     Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in~     ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis~     Metrology Index (BASMI). Being obese or slim may affect TWD. As well as the person's losing~     or taking weight may lead wrong evaluations, in comparative studies, according to the height~     or weight uneven distribution of groups may affect the results. The aim of this study is to~     investigate whether the body shape affect TWD or not.~   "
92713|NCT01843634|"~     This is an open-label pilot study evaluating the safety and preliminary evidence of a~     therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard~     induction and consolidation therapy for acute myeloid leukemia.~   "
92727|NCT01843452|"~     There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal~     cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR~     antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial~     investigates concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy.~     Treatment components used in this study have been selected on scientific rationale. The~     trial regimen should be feasible with acceptable toxicity and outcome similar to historic~     series.~   "
92700|NCT01843803|"~     This study will use a multi-phase mixed-methods approach to develop and test a patient~     inventory to facilitate patient-centered care delivery. In Phase I the investigators will~     identify which factors should be considered for inclusion in the patient inventory. This~     will involve qualitative data collection with providers and patients using interviews and~     focus groups, respectively; and developing a question repository. The interviews and focus~     groups will take place at the six study sites: Hines VA Hospital and two Community Based~     Outpatient Clinics(CBOCs) in LaSalle, IL and Kankakee, IL; Jesse Brown VA Medical Center;~     and two CBOCs in Crown Point, IN; and Chicago Heights, IL. The question repository will~     involve a research assistant (RA) performing a literature review to gather items related to~     areas of patient context.~      Phase II will develop and test an item inventory using a Delphi panel - a panel of~     stakeholders including Veteran representatives, VA providers, researchers and~     representatives from the investigators' operations partners. The panel of at least 14~     respondents will develop a questionnaire through three rounds of email exchanges ranking the~     list of items to be included in the patient inventory. Once the patient inventory is~     finalized, it will be integrated into an iPad application for patient use.~      In Phase III the investigators will test the patient inventory in a randomized trial.~      The investigators will conduct a randomized trial of the patient inventory to a control~     condition (e.g., healthy living video) to assess whether use of the inventory results in~     care that is more patient-centered and decisions that are more collaborative. Eligible~     participants will be identified and recruited from the Patient Aligned Care Team (PACT)~     clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either~     complete the patient inventory on the iPad or watch a health video on the iPad. Patients in~     the Intervention group will give a copy of the summary of the inventory to their provider.~     Both groups will be asked to carry a concealed tape recorder during their visit. Following~     the visit, patients in both groups will complete a set of questionnaires about the encounter~     including the CARE and CCM. The recordings will be analyzed by the team using a coding~     system developed in a previous Health Services Research and Development (HSR&D) study to see~     if the use of the patient inventory facilitated patient-centered care during the encounter.~     A second coding scheme, the Informed Decision Making (IDM) will also be applied to examine~     collaborative decision making.~   "
92701|NCT01843790|"~     The primary objective of this study is to compare the change in estimated glomerular~     filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The~     secondary objective is to determine the safety and tolerability of GCS-100 administered for~     8 weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on~     circulating galectin-3 and other markers of disease activity.~   "
92702|NCT01843777|"~     The purpose of this study is to compare two different ways of helping first-time hearing-aid~     users get the most out of their hearing aids and determine if one method is better than the~     other. One method provides the patient with routine information regarding the care and use~     of hearing aids the other method uses tools to address patient-specific barriers against and~     motivators for hearing-aid use.~   "
92703|NCT01843764|"~     The aim of the study was to follow clearance of malaria infections and detection of new~     malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this~     purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on~     Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and~     one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children~     during 42 days.~   "
92704|NCT01843751|"~     The proposed work addresses critical health and public safety issues in the U.S. and in~     Wisconsin: the intersection of addiction and crime and the prevention of associated~     individual and public health complications. The results will provide justification for the~     expanded involvement of primary care in the treatment of substance-related disorders (opioid~     dependence in particular) and the prevention of their complications. As such, the project~     answers to federal calls for the expansion of substance abuse treatment into primary care~     settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin~     2020.~   "
92705|NCT01843738|"~     Patients are being asked to take part because they have melanoma that has spread to other~     organs in their body (metastatic). As part of this study, patients will receive radiation~     therapy and an approved drug (Vemurafenib).~   "
92706|NCT01843725|"~     Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to~     assess the safety and tolerability of capecitabine given in combination with aflibercept in~     patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in~     terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To~     establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with~     Aflibercept.~   "
92707|NCT01843712|"~     Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of~     hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link~     these measurements with individual characteristics (adiposity, age, gender) and parental~     feeding practices.~      Design: Three consecutive weeks an identical lunch was served in four preschool canteens~     reaching 236 children. The first lunch was a control session. For the CC situation (week 2),~     thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH~     situation (week 3), ten minutes after lunch children were exposed to palatable foods (430~     kcal). Food intake was measured at the individual level. Parental eating behaviour and~     feeding practices were measured by questionnaires. Child's height and weight were measured~     by a medical doctor.~   "
92708|NCT01843699|"~     Objectives: Pathological gambling (PG) is a prevalent disorder with no approved~     pharmacological treatment. Previous reports suggest that topiramate could be useful in~     reducing impulsivity in PG, and craving in other addictions. The goal of this study was to~     investigate the effectiveness of topiramate combined with brief cognitive restructuring in~     treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo~     (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring.~     The main outcome measures were craving, gambling behaviour, gambling cognitive distortions,~     impulsivity, depression and social adjustment.~   "
92709|NCT01843686|"~     This study will demonstrate the safety of the application of autologous platelet rich plasma~     (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree~     burns. The study will be a randomized, double-blinded controlled safety study. Investigators~     expect that the PRP will deliver improved hemostasis and growth factors at the wound site~     thus increasing the effectiveness of treatment at the wound site. This will lead to rapid~     production and delivery of an autologous therapy that should minimize additional morbidity~     to the patient.~   "
92710|NCT01843673|"~     This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during~     treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses~     high quality imaging technology to detect the tumor and normal organs during treatment. It~     is not yet known which imaging technique provides the best image for guidance during~     treatment with radiation therapy. Comparing results of imaging procedures done before,~     during, and after radiotherapy may help doctors plan the best treatment.~   "
92714|NCT01843621|"~     The purpose of this study is to find out more about the two doses of dengue vaccine, over a~     five year period, that the children received in the Dengue-003 study and to study a third~     dose of dengue that will be given to the children~        -  Do children still have dengue antibodies intended to provide protection against dengue~          infection one year after the two doses of vaccine given in study Dengue-003?~        -  Were there any major medical problems that appeared as dengue-like symptoms during the~          one year after vaccinations?~        -  Will a third dose of dengue help to further stimulate the part of the immune system~          intended to help protect against dengue infection?~        -  Is a third dose as safe as the first two doses?~        -  Are the local reactions to a third dose of the vaccine similar to what your child~          experienced after the first two doses?~   "
92715|NCT01843608|"~     Breast cancer survival it is affected by the side effects related to the illness, the~     treatments or even the behavioral factors (e.g. inadequate diet, sedentary behavior) that~     create in this women an important quantity of psychological and physical disorders. Prior~     systematic reviews and meta-analyses have demonstrate that supervised aerobic training is a~     safe, feasible, and effective adjunct therapy to improve a broad range of physiological and~     psychological outcomes in women with early breast cancer. However the vast majority of~     studies to date have focused on the efficacy of exercise to improve symptom control outcomes~     in breast cancer patients either during or following the completion of adjuvant therapy.~      Most relevant consequences are found in women that have to undergo surgery as 16% to 43% of~     women with breast cancer suffer functional limitation in the shoulder, inflammation, pain or~     strength and flexibility reduction in upper body limbs one year after surgery with a high~     prevalence which is rising.~      Weight gain is associated with decreased quality of life and increased risk for several~     comorbid conditions, such as cardiovascular disease and diabetes. The most of the~     cardiopulmonary problems are induced by chemotherapy or radiotherapy, because of the~     treatments effect in the heart and its consequences in cardiorespiratory fitness of these~     women.~      These side effects become in important limitations to allow women return their normal life~     style. These limitations have a severe effect in decreasing of physical activity practice,~     which have visible consequences in increasing general fatigue and calcium deficiency in~     bones due to the age and some adjuvant treatments.~      Previous studies found that patients with breast cancer who gained modest amounts of weight~     were significantly more likely to experience disease recurrence and die from breast cancer~     and other causes that those who were weight stable. In addition, two thirds of the studies~     that have assessed body composition change in relation to weight gain in this patient~     population observe no net gain in muscle mass or loss in muscle mass as body weight and~     adipose tissue increase. These changes are defined as sarcopenic obesity. This kind of~     obesity is characterized by weight gain in the presence of lean tissue loss or absence of~     lean tissue gain. In addition fat tissue gain is related with other health disorders such as~     diabetes, functional limitations and poor survival levels. Treatment for this unique pattern~     of weight gain is an exercise intervention, especially strength training.~      Psychological effects have to be took account as cancer produce important aftermath. Large~     scientific evidence shows the psycho-emotional alterations in women diagnosed with breast~     cancer at some point in their life.~      World Health Organization (WHO) defines quality of life as individuals perception of their~     position in life in the context of the culture and value systems in which they live and in~     relation to their goals, expectations, standards and concerns. It is a broad ranging concept~     affected in a complex way by the person's physical health, psychological state, level of~     independence, social relationships, personal beliefs and their relationship to salient~     features of their environment. Following this definition numbered of researches have been~     developed, presenting interest in both physiological and psychological changes and~     improvements, as show different studies.~      HYPOTHESIS The primary hypothesis of this study is that group exercise intervention,~     combining aerobic and strength training, will reduce lean mass and body fat tissue in breast~     cancer post treatment survival.~      Secondary hypothesis of this clinical trial are follows:~        1. Combined exercise intervention will increase maximal strength level of chest press and~          leg press.~        2. Combined exercise intervention will increase maximal cardiopulmonary capacity, assessed~          by Peak Oxygen Consumption(VO2peak), which has been confirmed as an important value in~          survivals. In addition, ACSM propose this value as the Gold Standard to assess fitness~          level.~        3. Combined exercise intervention will increase global Isometric Strength Index, assessed~          by Grip Strength Dynamometer.~        4. Combined exercise intervention will improve range motion in upper-limbs.~        5. Patients Reported Outcomes (PROs), such as quality of life (QoL), Health perception and~          depression.~   "
92716|NCT01843595|"~     The purpose of this study is to test the effect of a new three-month behavioral weight loss~     program among adult men. Weight will be measured at three and six months post randomization.~     The intervention will be compared to a wait-list control group. Participants will be 112~     overweight and obese men (18-65) living in the Chapel Hill/Raleigh/Durham area. The~     behavioral intervention tested will be delivered online with two face-to-face group~     meetings. Intervention content will be delivered via email and online. It is hypothesized~     that men randomized to the REFIT intervention will lose more weight at 3 months than men~     randomized to the wait-list group.~   "
92717|NCT01843582|"~     The study is aimed to develop a new reaction-time based method for examining the visual~     field and to study the effect of refractive error on the magnification of a fundus~     photograph in order to evaluate the true size of a retinal feature.~   "
92718|NCT01843569|"~     We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection~     combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected~     population of infertility patients who cannot tolerate exogenous gonadotropins or are at~     risk of ovarian hyperstimulation syndrome.~   "
92719|NCT01843556|"~     A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety~     and pharmacokinetics.~   "
92720|NCT01843543|"~     Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge~     to urinate that is difficult to prevent) is commonly experienced in patients with overactive~     bladder. New findings have discovered that urgency incontinence may be connected to the~     interactions of certain regions of the brain and the bladder. Although this is a common~     problem, researched still do not know how these interactions impact the process of urgency~     incontinence. Furthermore, there is preliminary data to suggest that interventions such as~     Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose~     of this study is to determine the impact MBSR training on UI symptoms, quality of life, and~     anxiety measures.~   "
92721|NCT01843530|"~     This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert~     for treatment of ACE induced Angioedema.~      This study should show that Berinert shortens the time to complete resolution of signs and~     symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when~     given on top of standard treatment. This study should also compare the time to onset of~     relief as defined by an at least one point reduction on the severity scale of ACE-induced~     angioedema with Berinert versus placebo.~   "
92722|NCT01843517|"~     This study seeks to further understand these three observations - (1) that the time period~     surrounding childbirth accelerates recovery from pain after injury (2) that this likely~     reflects dampened facilitating mechanisms and exaggerated inhibitory mechanisms, and (3)~     that stress may interfere with this protection. In this study the investigators will compare~     women within 2 weeks of delivery to age matched controls and anticipate that pain inhibition~     is increased after delivery, pain facilitation is decreased, and that there is a~     relationship between these pain responses and the degree of pre-existing stress.~   "
92723|NCT01843504|"~     The goal of this study is to find an effective treatment for chronic patellar tendinopathy~     (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine~     whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes~     with correlation to a new method of ultrasound (US) imaging assessment called~     Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future~     larger scale studies to help establish an optimal protocol for the nonsurgical management of~     PT.~   "
92724|NCT01843491|"~     This is an open label Phase 1 study of the Ad-PfCA vaccine designed to 1) provide reagents~     for the development and refinement of cell-mediated immunoassays for measuring the human~     immune response to candidate malaria vaccines (especially protective malaria vaccines such~     as DNA/Ad-PfCA where better assays are needed to identify the correlates of protective~     immunity) and 2) to provide a repository of antigen-specific PBMCs that can be used as~     positive and negative controls in cell mediated immunoassays.~   "
92725|NCT01843478|"~     Cervical cancer is the second most common type of cancer among women worldwide. Women with~     human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its~     precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk~     Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap~     tests in the year following diagnosis, and if both are normal, yearly thereafter.~     Nationally, only 25% of women meet this recommendation. The mean annual Pap testing rate for~     federally funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the~     Johns Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap~     testing rate of 59%. This occurred despite interventions to address adherence issues were~     implemented, including nurse case management, co-location of HIV and gynecology services,~     flexible scheduling, and continuity of care. Women keep their appointments for HIV primary~     care more often than for gynecology care in the Moore Clinic, so an intervention that takes~     place during a primary care visit could improve cervical cancer screening rates.~      The availability of HPV testing provides a unique opportunity to increase perceived~     susceptibility to and severity of cervical cancer among women with HIV, and to encourage~     follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for~     the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates~     a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2%~     risk of developing CIN. HPV testing can be easily conducted by women themselves through~     self-collection in a primary care visit. Studies of women without HIV who do not have~     regular Pap testing have demonstrated that self-collected HPV testing and results counseling~     increases the overall screening rate, and women who test positive for HPV have a high rate~     of follow-up Pap testing. Self-collected HPV testing and results counseling could be~     utilized in the HIV primary care setting to promote Pap testing among women with HIV.~   "
92726|NCT01843465|"~     According to data from high volume Centres, documentation of entry block with the Achieve~     catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to~     assess strategies using the Achieve catheter that can improve this performance.~   "
92728|NCT01843439|"~     We want to examine the effect of multidisciplinary interventions in asthma patients who had~     experienced acute exacerbation of asthma.~      In our previous observational studies, elderly asthma patients had a some distinct features~     such as impairment of cognitive function, deficiency of micronutrient and absence of~     caregiver compared with young adult asthmatics.~      We wanted to evaluate whether the long-term course of asthma could be modified by~     intervening deficienies which were found in elderly patiensts.~      So, we designed a interventional study to correct above risk factors in elderly asthma~     patients, which could be aggravating their asthma. Followings are our specific~     multidiciplinary items that we want to correct.~        1. popularize and educate the asthma action plan~        2. run a emergency call system for acute exacerbation~        3. educate the proper techniques using inhalers~        4. correct the deficiency of magnesium (magnesium 500 mg per day)~      After 1 years, we will measure the numbers of acute exacerbations, lung function including~     FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study~     patients.~   "
92729|NCT01843426|"~     The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of~     patients after a computed tomography (CT) scan. The results of this study will help to~     determine the minimum volume of contrast material that can be used to ensure patient safety~     while not compromising diagnostic image quality in high-risk patients.~   "
92730|NCT01843413|"~     This phase I/II trial studies the side effects and the best dose of stereotactic~     radiosurgery and to see how well it works in treating patients with large brain metastases.~     Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.~   "
92731|NCT01843400|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Regorafenib for colorectal~     cancer.~      The objective of this study is to assess safety and effectiveness of Regorafenib using in~     real clinical practice.~      A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational~     period. At 12 months after the first administration of Regorafenib for confirmation of~     efficacy information including treatment duration and survival status of the patient.~   "
92732|NCT01843387|"~     The study investigates the safety, tolerability and efficacy of a single intravenous~     infusion of two doses of mesenchymal precursor cells versus placebo in subjects with~     diabetic nephropathy and type 2 diabetes.~   "
92733|NCT01843374|"~     This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with~     unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio~     to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at~     study centers in multiple countries. The study consists of a screening period, a treatment~     period, a 90-day follow-up period for safety, and a long-term survival follow-up period.~   "
92734|NCT01843361|"~     The aim of this study was to determine the prevalence rate and risk factors for chemical~     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.~   "
92735|NCT01843348|"~     This study is designed to evaluate the renal function comparing Certican based~     immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a~     standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant~     recipients.~   "
92736|NCT01843335|"~     X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular~     aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate~     information about endoleak after EVAR. Benefits of CEUS over CT include less radiation~     exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent~     application and decrease in the cost of EVAR follow-up. This study is designed to~     investigate if results from literature are reproducible in St Olavs Hospital in Trondheim~     (Norway), to gain experience with the technique and to introduce CEUS as an alternative for~     detection of endoleak in this hospital.~   "
92737|NCT01843322|"~     The study is aimed at investigating whether repair of endoleak type II can be improved by~     adding navigation technology. Can this technology increase precision by guiding the needle~     that punctures through the skin as used during the repair procedure? Can the procedure~     logistics be improved by using navigation technology instead of computed tomography (CT)~     guidance of the needle puncture? Parameters logged during the procedure:~        -  was the needle placement successful?~        -  number of needle punctures?~        -  time used on guidance procedure~        -  X-ray exposure dose~   "
92738|NCT01843309|"~     Purpose Invasive fungal infections cause significant morbidity and mortality in~     immunocompromised patients.~      Amphotericin B deoxycholate (AmB) is a polyene antifungal agent. The broad spectrum of~     activity contributed to it being considered the gold standard of antifungal therapy despite~     being associated with high incidences of infusion related adverse events.~      AmB exerts their antifungal effect binding to ergosterol; a sterol similar to cholesterol~     found in fungal cell membranes. However AmB also binds to cholesterol molecules in mammalian~     cell membranes forming intramembranous pores and vacuoles in the distal convoluted tubule of~     the kidney producing its nephrotoxic effects.~      Nephrotoxicity is the major adverse effect of AmB, often limiting administrations of full~     dosage; it's manifested as acute kidney injury, impaired renal concentrating ability,~     augmented urinary potassium secretion through tubular Na+/K+ ATPase, type-1 renal tubular~     acidosis, which increases the elimination of potassium, and magnesium wasting. Furthermore~     potassium depletion potentiates the tubular toxicity of AmB.~      The management of potassium wasting may be difficult, even high intravenous doses of~     potassium chloride may not be fully effective in correcting the hypokalemia. It has been~     probed the use of potassium-sparing diuretics to limit electrolyte wasting in patients~     treated with AmB.~      In 1988 Smith et al, demonstrated that amiloride was well tolerated and provided effective~     control of plasma potassium in patients treated with AmB. This finding was confirmed in 2001~     by Bearden et al. However in our country the only available commercial presentation of~     amiloride also contains hydrochlorothiazide, limiting its use in such patients.~      Spironolactone acts on the distal renal tubule by competitive inhibition of aldosterone,~     thereby blocking the exchange between sodium and both potassium and hydrogen in the distal~     tubules and collecting ducts. These agents produce a sodium diuresis which results in~     potassium retention. There is only one clinical trial by Ural et al, using spironolactone to~     prevent hypokalemia in twenty-six neutropenic patients on AmB treatment; they demonstrated~     that those patients receiving concomitant AmB and spironolactone (100mg bid) had~     significantly higher plasma potassium levels than those receiving AmB alone (P=0.0027) and~     required significantly less potassium supplementation to maintain their plasma potassium~     within the normal range (P=0.022).~      Renal vasoconstriction appears to play a major role in AmB induced reduction in GFR;~     recurrent ischemia may lead to structural and tubular damage and permanent nephrotoxic~     effects.~      Aldosterone modulates the tone of the renal vasculature. Bobadilla et al have shown in~     animal models of cytotoxic damage using cyclosporine; that a mineralocorticoid receptor~     blockade with spironolactone reduces the structural renal damage, and also prevents renal~     dysfunction due to afferent and efferent vasoconstrictions. This group has also shown that~     prophylactic treatment with spironolactone completely prevents renal dysfunction and~     histological signs of tubular injury from ischemia-reperfusion injuries. And also has~     demonstrated the ability of spironolactone in animal models to protect the kidney after~     establishing an ischemic insult, when spironolactone was administrated immediately or 3h~     after the renal ischemic insult had occurred, reducing levels of sensitive biomarkers such~     as Kim-1 and Hsp70.~      The investigators' hypothesis is that administration of spironolactone in patients treated~     with AmB will help to maintain significantly higher plasma potassium levels and will help to~     reduce potassium and magnesium supplementation. Moreover spironolactone will help to reduce~     the urinary excretion of potassium.~      The investigators propose a randomized, double blind, placebo controlled trial approved by~     the local ethical committee, to compare the efficacy and security of spironolactone to~     reduce electrolytic derangements in three groups: AmB and placebo, AmB and spironolactone~     100mg once a day, AmB and spironolactone 100mg twice a day. The investigators will include~     12 patients per group. Researchers will collect daily plasma creatinine, sodium, potassium,~     BUN and urinary potassium, as well as the values of potassium and magnesium supplements~     administered orally or parenterally. The researchers will also collect by 7 days urinary~     levels of NGAL, KIM-1 and Hsp-70 as tubular injury markers.~   "
92739|NCT01843296|"~     The purpose of this study is to Compare three methods of intrathecal bupivacaine;~     bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and~     postoperative pain in patients undergoing lumbar disk herniation surgery.~   "
92740|NCT01843283|"~     The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the~     revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison~     group. Specific aims are as follows:~      Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect~     sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and~     family caregivers' satisfaction with and perceptions of DEMA or IS.~   "
92741|NCT01843270|"~     The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It~     achieves a reliable airway with a low incidence of major complications and~     pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the~     proper size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size~     4 for 70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper~     airway and decreases the pharyngeal cross sectional area. Also it was reported that~     pharyngeal area was reduced according to the increasing of BMI. Therefore, the aim of this~     study is to determine which of actual body weight or ideal body weight is proper on the size~     selection of laryngeal mask airway.~   "
92742|NCT01843257|"~     The investigators wish to study the effects of three forms of bariatric surgery: gastric~     bypass, sleeve gastrectomy, and lap banding. The surgery is not part of the clinical trial.~     If insurance does not cover the procedure, then the patient is responsible for payment of~     the surgical process. The investigators are doing pre- and post-surgery testing to provide a~     better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol~     absorption, distribution and elimination from the body; 2) the effects of alcohol on blood~     sugar; and 3) the effects of alcohol on mood.~   "
92743|NCT01843244|"~     Data from both the traditional invasive cardiac monitors and the Nonin will be collected~     simultaneously. The investigators will analyze Nonin data for peak and trough variation with~     respiration, area under the curve, time from trough to peak, and slope, and compare these to~     data collected from the invasive monitors to look for correlations in clinically important~     parameters such as blood pressure, central venous pressure, cardiac output, etc.~   "
92744|NCT01843231|"~     This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the~     safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight~     loss intervention compared to a diet and exercise control only. Mean % Total Body Weight~     Loss [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the~     primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the~     treatment group is a co-primary endpoint.~   "
92745|NCT01843218|"~     Erectile dysfunction will be explored by recording R / P and self-administered questionnaire~     IIEF-5.~   "
92746|NCT01843205|"~     Methamphetamine use disorders are an unrelenting public health concern. Intensive research~     efforts have yielded behavioral interventions that reduce methamphetamine use, however,~     these interventions are not universally effective and treatment effects diminish over time.~     Development of a pharmacotherapy that enhances the efficacy of these interventions is a~     priority for the National Institute on Drug Abuse. This study proposes to determine the~     impact of buspirone maintenance on self-administration of methamphetamine. These preliminary~     data will be used to support further research developing buspirone as a pharmacotherapy for~     methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate~     the reinforcing effects of methamphetamine.~   "
92747|NCT01843192|"~     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery~     (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH®~     Staplers 45 mm and/or 60 mm (study devices).~   "
92748|NCT01843179|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug is effective in treating~     a specific cancer. Investigational means that sulindac is still being studied and that~     research doctors are trying to find out more about it. It also means that the FDA has not~     yet approved the use of sulindac for your type of cancer.~      Participants in this study must have undergone previous chemotherapy and achieved complete~     remission, which is the absence of disease activity in people with a chronic illness, in~     this case AML. Unfortunately, a significant number of patients with AML who achieve a~     complete remission with initial chemotherapy eventually experience a relapse, often within a~     few months.~      Previous research studies have demonstrated that a type of medication frequently used to~     treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX~     inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX~     inhibitors are ibuprofen and naproxen.~      For this study, the investigators are using a COX inhibitor called sulindac, which has been~     FDA approved and used to treat pain and inflammation for many years, and has also been~     studied in suppressing certain tumors of the gastrointestinal system. The main goal of this~     study is to determine whether sulindac can help participants remain in a state of complete~     remission following the initial course of chemotherapy for AML, and two cycles of~     chemotherapy that is standard of care for your cancer, called consolidation chemotherapy.~     During the course of this study, the investigators will also attempt to learn more about how~     COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by~     studying the participants on this trial.~   "
92749|NCT01843166|"~     Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal~     estrogen cream treatment with the pessary will be randomized amongst the patients and~     patient satisfaction and complication rates will be assessed during follow-up.~   "
92750|NCT01843153|"~     The role of a sciatic block in addition to a femoral block remains controversial. The study~     addresses this topic by comparing a continuous block versus an injection on demand.~   "
92751|NCT01843140|"~     The FIRST project is a national fertility preservation registry for young women facing~     cancer treatments. The investigators will examine how different cancers and treatments~     affect the reproductive health of young survivors. This prospective cohort study seeks to~     recruit young women close to time of cancer diagnosis and treatment. Participants will~     answer a yearly questionnaire on their current health. A subset of participants will provide~     dried blood spots to measure reproductive hormones. The primary goal of the study is to~     determine the risk of infertility and time to pregnancy in young female cancer survivors.~   "
92752|NCT01843127|"~     To explore the mechanism of action of ranolazine as a potential treatment for type 2~     diabetes mellitus (T2DM).~   "
92753|NCT01843114|"~     The prevalence of diabetes and diabetes-associated complications is still increasing.~     Several major long-term complications of diabetes such as cardiovascular disease, chronic~     renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given~     that the eye provides the unique possibility in the human body to directly visualize blood~     vessels, much interest has been directed towards studying the ocular circulation. Although~     data of large epidemiological studies indicate that changes in retinal vessel caliber~     reflect other diabetes related factors, such as fasting glucose levels, there is still~     conflicting evidence on blood flow alterations in patients with diabetes. This is also~     related to the fact that up to now, methodological difficulties aggravate the assessment of~     blood flow changes in the retina in larger groups of patients. In the present study we~     propose to overcome this problem by using a technique called bi-directional Fourier Domain~     Doppler Optical Coherence Tomography (FDOCT), which we have developed in the recent years to~     measure retinal blood velocities. This technique allows for the non-invasive investigation~     of blood flow changes in human retina and will help us to better understand diabetes related~     vascular changes. The present study will use this technique to assess retinal blood flow~     changes in patients with diabetes and healthy subjects.~   "
92754|NCT01843101|"~     The aim of the present study is to develop a protocol for optimal corneal 3-dimensional~     imaging based on measurements in healthy volunteers. For this purpose, a customized~     ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can~     also be applied in patients with corneal pathologies, for whom it is intended to be used,~     measurements in these patients will be performed. We propose to obtain images from patients~     with keratoconus, since this is one of the most frequent causes for corneal transplantations~     in Europe and from patients with corneal neovascularization which is a major cause of vision~     loss in several ophthalmic diseases. Based on the obtained measurement protocol, further~     studies investigating the pathophysiology or treatment success of several corneal~     pathologies can be planned.~   "
92816|NCT01842295|"~     The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding,~     bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological~     parameters, lifestyle, quality of life) involved in fertility of obese adult men.~   "
92755|NCT01843088|"~     Mannitol cream has been shown clinically to be effective for pain control. To determine if~     this effect is worth testing on a larger scale, 170 runners will receive a sample of 25%~     mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg~     following a 10 km or longer run, and for the following five days. Mannitol and control legs~     will be chosen at random for each runner. Pain scores before and after cream application~     will be acquired each day for each leg. Means and standard deviations found will be used to~     determine the size of a larger study.~   "
92756|NCT01843075|"~     This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study~     in patients with mild Alzheimer's dementia (AD). The investigators aim to recruit patients~     with mild Alzheimer's dementia as defined by the National Institute of Neurological and~     Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association~     (NINCDS-ADRDA) Criteria for Probable Alzheimer's Dementia or meeting Dubois criteria for~     early AD, with Mini Mental State Evaluation score of at least 22 out of a maximum of 30 and~     a CDR Global score of 0.5 or 1.~      Patients will be randomised on a 1:1 ratio to receive liraglutide or identical matching~     placebo.~   "
92757|NCT01843062|"~     The study is designed to evaluate the clinical efficacy, safety and tolerability of~     selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.~   "
92758|NCT01843049|"~     Most local failures after definitive chemoradiation for unresectable esophageal cancer occur~     in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located~     in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective~     dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated~     boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the~     esophageal GTV defined prior to treatment may improve local tumor control.~   "
92759|NCT01843036|"~     The aim of this randomized controlled trial (RCT) is to conduct a second, independent~     evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse~     home-visiting program to prevent child maltreatment and improve child and family health and~     well-being. Durham Connects is the first home-visiting program that is designed to prevent~     child maltreatment and improve health and well-being outcomes in an entire community~     population.~      Program evaluation will test four hypotheses: 1) The program can be implemented with~     population reach, fidelity to the manualized intervention protocol, and reliability in~     assessment of family risk; 2) Random assignment to the Durham Connects program will be~     associated with lower rates of child maltreatment and emergency department~     maltreatment-related injuries, better pediatric care, better parental functioning, and~     better child well-being than assignment as control; 2) Intervention effect sizes will be~     larger for higher-risk groups; and 3) Community resource use and enhanced family functioning~     will mediate the positive impact of Durham Connects on outcomes.~   "
92760|NCT01843023|"~     The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old~     opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual~     (TAU).~   "
92761|NCT01843010|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted~     in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients~     aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general~     anesthesia will be involved in this study. According to previous studies and our pilot~     trial, estimated 120 patients will be involved in this study. All eligible patients will be~     randomly assigned to two groups. In group P, patients will receive parecoxib 40mg~     intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group~     C, patients will receive normal saline at the same time points. The shoulder pressure pain~     thresholds will be measured with a pressure algometer by an independent doctor blinding to~     medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the~     intensity of shoulder pain and side effects will be evaluated by another independent doctor~     at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal~     shoulder pain will be assessed.~   "
92762|NCT01842997|"~     Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in~     population in China. However, there was little epidemiological evidence of safety when~     vaccinated in healthy pregnant women. The main objective of this study is to assess the~     safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in~     healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant~     women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old~     who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination.~     The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups:~     vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were~     administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no~     vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And~     observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated;~     and protective effect was observed for six months.~   "
92763|NCT01842984|"~     The purposes of this study are: (1) decrease loneliness and social isolation and increase~     social competence and social integration of older adults experiencing loneliness; (2)~     examine an intervention process grounded in a theoretical model that was developed in a~     previous study. The intervention process is tailored to the participants' barriers and~     abilities, and includes up to 10 personal meetings with an activities counselor and several~     group meetings.~   "
92764|NCT01842971|"~     The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients~     with liver metastasis from colorectal cancer.~   "
92765|NCT01842958|"~     The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone~     Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC~     SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery~     and 12 months post-implant placement. The secondary objectives will assess differences in~     clinical outcomes between the test and control implants, including implant success and~     survival, gingival recession, subject satisfaction and additional early bone level~     measurements.~   "
92831|NCT01842087|"~     A single blind, six week dietary intervention will be conducted in order to evaluate the~     impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life~     in patients presenting with a moderate to severe decline in kidney function.~   "
92766|NCT01842945|"~     The aim of this study is to examine the effects of cognitive behavior therapy (CBT) for~     procrastination, and to investigate whether it can be delivered via the Internet. Two~     treatment groups will be used, one with therapist contact and one without, as well as a~     wait-list control group. It is assumed that the treatment group with therapist contact will~     be superior to the treatment group receiving no therapist contact since procrastination can~     be partially explained as a self-regulatory failure. Both treatment groups are presumed to~     be superior to the wait-list control.~   "
92767|NCT01842932|"~     Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind~     controlled trial~   "
92768|NCT01842919|"~     In this project investigators will evaluate the benefits of contemporary dance training~     using a comprehensive test battery combining standard neuropsychological batteries,~     psychological questionnaires on emotion, empathy and quality of life, structural~     magnet-resonance tomography (MRI), as well as psychophysical tests on movement recognition~     and agency, the sense of being in control of one's own movement.~      For 10 years now two experienced dancer‐choreographers lead dance workshops for people with~     Huntington's Disease (HD) and their family and caregivers in Paris. This project will~     evaluate objectively the effects these workshops have, by assessing a new group of 18~     patients and their partners and caregivers before and after 8 month of weekly dance~     training.~      People with HD are troubled by involuntary movements, of which they are however not~     accurately aware, but moreover they become impaired at recognising instrumental actions in~     others. It is well known that observing somebody else's action and executing the same action~     rest on a common neural network. This might mean that improving one's own action execution~     can improve the observation and understanding of others' actions in turn. Here,~     investigators will investigate both the impact the movement impairments caused by HD might~     have on patients themselves as well as on their partners and caregivers, as a consequence of~     the fact that own and other action representations are shared. After 8 months of~     contemporary dance training, both groups will be tested again, in order to establish if both~     action execution (self) and perception (in others) have improved.~      Other recent psychophysics and brain imaging experiments have demonstrated how the sense of~     agency is composed from external cues (for example sound) of the consequences of movements,~     and from internal sensorimotor information that result from the action plan. Importantly, in~     HD the latter input might be impaired, but this has never been systematically tested. Making~     use of a psychophysics paradigm disentangling the two cues to agency investigators first~     monitor the sense of their own movement in HD, and further assess the changes in agency and~     in the role of these cues to agency after eight months of contemporary dance practice.~      Finally investigators will monitor the structural brain changes accompanying this progress,~     comparing the brain before and after regular dance practice and correlating action~     recognition psychophysics measures of agency with these changes.~      In sum, this project has a double impact. Firstly it will scientifically evaluate the impact~     of dance on the normal but especially the brain affected by a neurodegenerative disease that~     causes movement impairments, and establish its effect on behaviour and wellbeing. Secondly~     it will evaluate in patient partners and caregivers how they represent the patients' as well~     as their own movements and how this changes with dance practice.~   "
92769|NCT01842906|"~     The study is examining if an over-the-counter device (Theravent) worn while sleeping can~     reduce acute mountain sickness upon awakening in a high altitude trekking population.~   "
92770|NCT01842893|"~     The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when~     used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.~   "
92771|NCT01842880|"~     The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the~     Chagas Disease prognosis. This analysis will be done through the correlation between the~     plasmatic levels of this molecule with functional and laboratory tests.~   "
92772|NCT01842867|"~     The purpose of this study is to analyze the efficacy of syndecan-4 as a biomarker on the~     Chagas Disease prognosis. This analysis will be done through the correlation between the~     plasmatic levels of this molecule with functional and laboratory tests.~   "
92773|NCT01842854|"~     The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the~     Chagas Disease prognosis. This analysis will be done through the correlation between the~     plasmatic levels of this molecule with functional and laboratory tests.~   "
92774|NCT01842841|"~     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)~     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent~     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1~     Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1~     Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher~     disease present with acute neurological deterioration, which leads to early death. Those~     with Type 3 disease typically display a more sub-acute neurological course, with later onset~     and slower progression.~      The primary objective of this study is to evaluate the long-term safety of every other week~     (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed~     study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.~      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type~     1 Gaucher disease.~   "
92775|NCT01842828|"~     Currently available smoking cessation treatments help only about 15% of smokers to quit~     long-term. These treatments do not typically address the behaviours and sensations~     associated with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of~     smoke on the throat). There is evidence that these elements influence smoking behaviour and~     cessation. Electronic cigarettes (EC) are a new product with a strong potential to be a~     realistic behavioural replacement for smoking.~      Whilst EC deliver nicotine, their use does not involve tobacco combustion, which is the~     primary source of the many thousands of dangerous chemicals to which smokers of conventional~     cigarettes are exposed. Studies on EC products and users indicate there is little doubt that~     they are substantially safer than conventional cigarettes.~      The investigators plan to conduct a study one of the very first studies to test the effects~     of adding EC to standard care on long-term validated outcomes. Before launching such a large~     and demanding trial however, data are needed on what proportion of smokers would be~     interested in using EC and what compliance with EC use can be expected, and no data exist to~     inform how large a sample is needed. This pilot study would provide such data.~      A total of 220 smokers would be recruited at smoking cessation clinics in London (n=20),~     Madrid (n=100), and Prague (n=100). Within each site, half the smokers would be randomised~     to receive standard smoking cessation behavioural support and medication (standard care;~     SC), and half to receive SC plus EC. The EC group would receive a four week supply of EC.~     The outcome measures for the study would be smoking status at 4 and 24 weeks after the~     target quit date, EC use, acceptability, and adverse events.~   "
92776|NCT01842815|"~     The purpose of this study is to collect further data on the safety and efficacy of removing~     unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.~   "
92777|NCT01842802|"~     The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser~     to reduce the volume of fat.~   "
92778|NCT01842789|"~     The purpose of this study is to test both user preference and speed of targeting with the~     use of the Acessa System with Targeting Animation Guidance (TAG).~   "
92779|NCT01842776|"~     The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis~     patients. It is a quality improvement project that consistent of 4 tracks. Tracks 1 & 2:~     Implement use of checklists of activities for staff to complete when patients are admitted~     to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition~     management, patient coaching, and communication between institutions. Track 3: Work with~     physicians to develop process to individualize post-hospitalization dialysis orders and~     improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to~     follow patients in the hospital and 30 days post-hospitalization to facilitate care and~     patient coaching.~   "
92780|NCT01842763|"~     The purpose of this non interventional research is to set up a French database, initially~     for 3 years, of patients suffering from refractory chronic headache disorders (chronic~     migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania~     continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.~      Every team using this neuromodulation approach in France is likely to participate in the~     network.~      Fifty patients a year are expected. They will be informed about data which are collected and~     why they are collected.~      The data will come from medical files and questionnaires filling out by the patients. The~     data will be collected on a case report form adapted to each refractory chronic headache~     disorder. The case report form pages will be faxed to the coordinating team who will enter~     the data in the database and analyse the data in a descriptive manner.~      These data are social and demographic data, medical data (headache features, headache~     functional and emotional impact, medications, and concomitant medical conditions), technical~     data (kind of electrodes and implantable pulse generator used, stimulation parameters~     chosen), and safety data.~      This research should provide an update on practices, an evaluation of the efficacy and long~     term safety of occipital nerves stimulation, and perhaps help in identifying response~     predictive factors to this neuromodulation approach.~   "
92781|NCT01842750|"~     This study aims to test the hypothesis that insertion of an endorectal balloon into a~     patient receiving radical prostate radiotherapy by treatment radiographers is feasible~     without the patient experiencing undue discomfort. In addition this study will test the~     hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises~     rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.~   "
92782|NCT01842737|"~     The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure~     back pain perceptions in participants who receive either chiropractic treatment or foot~     massage. The study will also measure back pain and function with research questionnaires and~     other measures.~   "
92783|NCT01842724|"~     The purpose of this study is to determine the difference in the results between Motec and~     Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.~   "
92784|NCT01842711|"~     A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical~     agent or agents have the potential to cause contact irritation or contact allergy in the~     skin. Allergy is only elicited in immunologically competent individuals who have become~     sensitized through exposure to the chemical agent at a sufficient concentration and for a~     sufficient duration of time.~   "
92785|NCT01842698|"~     Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary~     surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain.~     Control of the pain is essential in the perioperative management.~      Nowadays, there are several strategies to support this pain, including regional anesthesia~     techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores~     and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as~     effective as epidural analgesia in the treatment of pain after thoracotomy and could present~     a more limited number of complications. However, there is no consensus on the best technique~     for realisation of PVB.~      Para-vertebral catheterisation can be performed by posterior approach in seeking a strength~     loss after bone contact of transverse vertebral process using the technique of Eason and~     Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context~     of all puncture invasive actions, is an effective contribution to the realisation of a BPV,~     but still insufficiently validated. First used to measure the distance skin - posterior~     costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography~     has recently led to the publication of echo-guided techniques combining recognition of~     structures defining the space para- vertebral, viewing the progression of the needle and the~     spread of the local anesthetic. The handling of the ultrasonographic probe associated with~     the puncture requires additional learning.~      The objective of this project is to study the feasibility of para-vertebral catheter~     insertion under ultrasonographic control. The appearance like pigtail of the catheter, the~     most recently proposed, seems the more attractive in terms of safety. The aim of this pilot~     prospective study is accurately quantify all qualitative parameters related to the technique~     in order to achieve a future validation with a medico-economic component.~      Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to~     medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.~      This study will be proposed to patients undergoing thoracotomy for total or partial~     pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of~     patients required is 60 patients over a period of inclusion of 12 months.~   "
92786|NCT01842685|"~     In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention~     (BTD) in patients with overactive bladder syndrome who failed previous treatment of~     anticholinergic drugs.~      The investigators' hypothesis is that it will improve the storage symptoms.~   "
92787|NCT01842672|"~     The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well~     tolerated and effective in children, adolescents and young adults with poor risk~     refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL).~   "
92788|NCT01842659|"~     Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region~     lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a~     mosaic pattern, rendering their detection difficult, especially given the scarcity of~     available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND)~     for imprinting abnormalities of the 11p15 region is not available.~      The recent development of a quantitative PCR method that permits the methylation index (MI)~     of imprinted regions to be calculated renders PND technically possible. Nevertheless,~     because of the mosaic nature of these anomalies, it is essential to verify that the~     methylation pattern of the 11p15 region obtained from the amniotic fluid matches that~     obtained from the blood.~   "
92789|NCT01842646|"~     This study is being done to see how safe an investigational drug is and test how well it~     will work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic~     myelomonocytic leukemia (CMML).~      The main purpose of this study is to see whether the participant's disease responds~     favorably to the investigational drug, PF-04449913.~   "
92790|NCT01842633|"~     The purpose of this multi-center study is to assess the efficacy of headache relief of new~     paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type~     headache (ETTH).~   "
92791|NCT01842620|"~     This is an open-label, single-center, randomized, 2-way crossover study to evaluate the~     bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference~     product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult~     subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period~     1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two~     500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following~     a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the~     treatment that they did not receive in Period 1.~   "
92792|NCT01842607|"~     This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab~     administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care~     in subjects who have severe, refractory asthma and a history of eosinophilic inflammation.~     Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to~     consent for this study.~   "
92793|NCT01842594|"~     Determine the objective response rate in sarcoma patients treated with hydroxychloroquine~     and sirolimus.~   "
92794|NCT01842581|"~     The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose~     delays the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a~     previous episode of HE.~   "
92795|NCT01842568|"~     Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although~     heart surgery provides important survival benefits, it is associated with potential major~     complications such as death, stroke, and heart attack. There is promising evidence that~     measurement of heart injury markers after surgery will identify patients at risk of death or~     major complications.~      This study will determine the current incidence of major complications in a representative~     sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current~     burden of complications will inform clinicians, administrators, government and granting~     agencies about resources required to address the problem. This study will also establish the~     role of measuring heart injury markers to identify important heart injury after heart~     surgery and the proportion that would go undetected without routine heart injury marker~     monitoring. This information will facilitate further studies of timely interventions. In~     summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have~     profound public health implications given the millions of adults worldwide who undergo heart~     surgery annually.~   "
92796|NCT01842555|"~     The data elements for the PDT Registry project include virtually all the elements in the~     standard hospital-based cancer registry record, although in some cases at a finer level of~     detail. All data points should be found in the participant's medical record. The principal~     difference between the PDT Registry data set and that collected by the registries is the~     inclusion of more information specific to PDT.~   "
92797|NCT01842542|"~     The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS~     therapy in women who have postpartum depression.~   "
92798|NCT01842529|"~     The aim of this prospective randomized double-blind study was to compare the efficacy and~     safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in~     early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial~     fibrillation undergoing coronary artery bypass graft (CABG) surgery.~   "
92799|NCT01842516|"~     Primary~        -  To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose~        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral~          dose in healthy male subjects~        -  To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male~          subjects~   "
92800|NCT01842503|"~     Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics~     (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate~     whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to~     alcohol cues in terms of urge to drink during the cue reactivity session and results in~     lower quantity of alcohol consumed during an alcohol self-administration session.~   "
92801|NCT01842490|"~     No serum biomarker has qualified for clinical use until now. However several biomarkers,~     especially markers of inflammatory or proteolytic activity seem to promising in the~     identification of vulnerable plaques. Moreover, recent study confirmed that~     contrast-enhanced ultrasound imaging(CEUS) can visualize intraplaque neovascularization and~     represent the plaque vulnerability. In this study we try to identify indicators through~     analysis of the relationship between plaque neovascularization seen by CEUS and well known~     biomarkers such as serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V),~     cystatin C, lipoprotein phospholipase A2, and hs-crp~   "
92802|NCT01842477|"~     Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal~     tissue. In Europe, about one million patients encounter a surgical bone reconstruction~     annually and the numbers are increasing due to our ageing population. Bone grafting intends~     to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of~     damage, but this is only attained presently by including cells capable of forming bone into~     the augmentation.~      Bone autograft is the safest and most effective grafting procedure, since it contains~     patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance~     osteoinduction), and it providing a scaffold for the new bone to grow into~     (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its~     harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with~     frequent consequent pain and complications.~      We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically~     implanted with synthetic bone substitutes contribute to the resolution of the health and~     socioeconomic complications of delayed union or non-union after diaphyseal and~     metaphyseal-diaphyseal fractures with safety and efficacy.~   "
92803|NCT01842464|"~     Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here~     to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.~   "
92804|NCT01842451|"~     A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of~     VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C~   "
94232|NCT01823913|"~     This study investigates safety and pharmacokinetic comparison of G-0081, a combination~     tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of~     amlodipine and valsartan (reference formulation) for single dose in healthy volunteers~   "
92805|NCT01842438|"~     Even with careful prostate surgery, men find it difficult to have an erection. Our previous~     research shows that couples are not often supported to cope with the effects of surgery on~     their sexual relationships. In this study, the investigators will design a way of supporting~     couples, and test how well it works.~      The investigators will decide what the support should include (e.g. duration, frequency and~     timing of the support). The investigators will do this by looking at available literature on~     the subject.~      The investigators will recruit 68 couples to the study, half will receive standard care and~     the other half will be invited to attend six sessions of psychosexual support with specially~     trained professionals (trained by men affected by prostate conditions and a cancer/couple~     support specialist). Before and after the support, men and their partners will be asked to~     complete questionnaires which measure quality-of-life, emotional needs, and their~     relationship. The investigators will ask the couples to fill out the questionnaires again~     six-months later to see if the support has long-term benefits. At the end of the study the~     investigators will also interview 10 couples to find out their views of the support, and~     another 10 couples about standard treatment.~      When the investigators have tested this support, they expect to see men and their partners~     tell us that their quality of life has improved, and they have higher satisfaction with~     their relationship. The investigators will calculate the overall cost of providing this~     support, and the benefits it has on reducing the need for other health-care services (like~     General Practice use).~   "
92806|NCT01842425|"~     The purpose of this study is to determine what changes occur in body- and liver-composition~     during four weeks of low calorie diet in morbidly obese females~   "
92807|NCT01842412|"~     The hypothesis of this study is that one bout of leg exercise gives acute qualitative~     changes in mitochondrial function in claudication. Final purpose is to determine the optimal~     exercise frequency in treatment of claudication.~   "
92808|NCT01842399|"~     Background:~      - Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it~     can have positive effects on human health. Lab studies show that it may help lower blood~     sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test~     different dose levels of Resveratrol to see what kind of effects it has on older overweight~     people. It will be tested in healthy volunteers at least 50 years of age.~      Objectives:~      - To test the effects of different dose levels of Resveratrol on heart and blood vessel~     health.~      Eligibility:~      - Healthy overweight nonsmoking volunteers at least 50 years of age.~      Design:~        -  This study will involve a screening visit and four study visits. Some of the study~          visits will involve overnight inpatient stays.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will be given a list of foods that they should avoid~          eating while on the study.~        -  Participants will be separated into three groups. Two groups will take different dose~          levels of the study drug. The third group will take a placebo.~        -  At the first study visit, participants will stay in the clinical center overnight for 2~          days of tests. They will provide blood and urine samples and have body scans to measure~          fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be~          performed. At this visit, they will receive their dose of the study drug. They will~          continue to take this dose for as long as they are on the study.~        -  The second visit will be 16 weeks after the first one. It will take only 2 hours, and~          repeat most of the tests from the screening visit.~        -  The third visit will be 16 weeks later. It will involve an overnight stay. Most of the~          tests from the second visit will be repeated.~        -  The fourth and final visit will be 16 weeks later. It will involve an overnight stay.~          Most of the tests from the initial study visit (including the scans and the exercise~          tests) will be repeated.~   "
92809|NCT01842386|"~     Background:~        -  Healthy people have white blood cells that protect them against bacteria, viruses, and~          fungi. However, some people have diseases which cause the body to make white blood~          cells that do not work properly. These white blood cells can attack the body s own~          proteins. These types of diseases are called anti-cytokine autoantibody-associated~          diseases. They can cause severe illnesses and even death. They are also difficult to~          treat with standard drugs.~        -  Rituximab is a drug used to treat rheumatoid arthritis. It attacks white blood cells~          that do not work properly. Currently, it is not approved for treating anti-cytokine~          autoantibody-associated diseases. However, researchers think that it may be able to~          help treat people with these immune diseases.~      Objectives:~      - To see if rituximab is a safe and effective treatment for anti-cytokine~     autoantibody-associated diseases.~      Eligibility:~        -  Individuals at least 18 years of age who have anti-cytokine autoantibody-associated~          diseases.~        -  Participants must also be enrolled in a related immune disorder study at the National~          Institutes of Health.~      Design:~        -  The study will last 24 months. Participants will take rituximab for 6 months and have~          follow-up visits for the remaining 18 months.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Other samples will be collected as needed if participants~          currently have an infection.~        -  Participants will enter the hospital for 1 week at the start of treatment. They will~          have four doses of rituximab given 2 days apart. This first treatment will be monitored~          with frequent blood tests.~        -  Over the next 6 months, participants will have four more doses of rituximab given about~          1 month apart. Treatment will be monitored with frequent blood tests and sample~          collections as needed.~        -  There will be four follow-up study visits at 3, 6, 12, and 18 months after the last~          dose of rituximab.~   "
92810|NCT01842373|"~     The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%)~     or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing~     discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No~     studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL,~     although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively.~      The hypothesis is that there will be no clinical difference between the two topical~     anesthetics.~   "
92811|NCT01842360|"~     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine~     (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo~     group.~   "
92812|NCT01842347|"~     The purpose of this study is to treat children with severe, moderate, resistant or relapsing~     C. difficile infection and to determine the changes in the intestinal microbiome (all of the~     bacteria living in the intestines) in children receiving FMT for C. difficile infection.~     Data will be collected throughout the FMT procedure to determine effectiveness and to help~     standardize this procedure. Stool samples will be collected to look at the different~     bacteria that are in the intestines before and after FMT.~   "
92813|NCT01842334|"~     1. Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS)~          vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine~          replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking~          nicotine-dependent outpatients.~        2. Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the~          process of extinction and the memory encoding process.~   "
92814|NCT01842321|"~     The purpose of this study is to estimate antitumour activity of abiraterone acetate in~     Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast~     Cancer.~   "
92815|NCT01842308|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with melphalan and to see how well they work in treating patients with multiple~     myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     melphalan, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill~     more cancer cells.~   "
92817|NCT01842282|"~     This study involves the use of a research drug, Amlexanox, for the treatment of type 2~     diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD).~     Amlexanox is taken orally in a pill three times a day. The investigators plan to continue~     therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The~     investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol,~     liver function, insulin resistance) and body composition characteristics (e.g. the pattern~     of fat distribution in the body). Seven eligible subjects in this study will also be~     evaluated for a change in liver disease by a liver biopsy.~   "
92818|NCT01842269|"~     Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept®~     Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney~     Transplant Patients~   "
92819|NCT01842256|"~     The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the~     pharmacokinetic properties of atorvastatin.~   "
92820|NCT01842243|"~     Despite considerable effort the optimal site to place a pacemaker lead at the time of~     pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at~     the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated~     with an increase in heart rhythm problems and also heart failure (impaired pumping~     function). The top of the ventricle (septum) has been investigated as an alternative site~     and is now routinely used by some centres. Previous estimation of the hearts pumping~     function (ejection fraction) has been limited to the use of echo (sound waves). Echo is not~     sensitive enough to detect small changes in the ejection fraction reliably (measure of~     pumping function of heart). The gold standard for measurement of ejection fraction is MRI~     (using magnets). Previous pacemakers have not been compatible with MRI scans. The latest~     generation of pacemakers are now able to be safely scanned within an MRI scanner. This~     allows a much more accurate estimation of the effects of a pacemaker on the ejection~     fraction which has not yet been studied.~      The investigators plan to study those patients undergoing a pacemaker implant and ablation~     procedure as part of their standard care.~      Individuals will have an exercise test, blood test used to measure biomarkers and fill in a~     symptom questionnaire.~      Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will~     be inserted, one apically and one septally. Only one lead will be used at any given time.~     Individuals will then undergo their planned AV node ablation.~      Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9~     and 18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart~     muscle strain, exercise testing and echocardiograms.~      The hypothesis is that a lead placed on the septum will produce superior cardiac performance~     over the short and long term.~   "
92821|NCT01842230|"~     The purpose of this study is to investigate the effect of Atorvastatin on the~     pharmacokinetic properties of Telmisartan/S-amlodipine~   "
92822|NCT01842217|"~     Validation of [18F]-FES for imaging of estrogen receptors in the brain~      The primary objective of the study is to determine if [18F]-FES Positron Emission Tomography~     (PET) can be used to quantify the estrogen receptor expression in the human brain.~   "
92823|NCT01842204|"~     A monocentric interventional randomized placebo controlled trial evaluating the efficacy of~     the post surgical and wound care recovery kit.~      It's a small device that consists of a thin metal ring that is placed on the skin surface,~     non-invasively. It's connected with a small battery. When the plastic tag is removed and the~     button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is~     created. It influences the receptor-ligand binding at the cell surface and might improve~     wound healing by diminishing wound edema and inflammation. It possibly helps reducing the~     inflammatory reaction induced by surgery.~      Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at~     the time of bandage, a kit will be applied at the level of the incision. One group will at~     random receive a working device, the other half will have a kit without active~     electromagnetic field.~      Postoperative analgesic consumption will be measured in a diary and pain and quality of life~     will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.~      The aim of this study is to evaluate whether the placement of the device reduces the acute~     postoperative pain and whether it reduces the incidence of chronic groin pain.~   "
92824|NCT01842191|"~     The aim of the present work was to evaluate the efficacy of fish oil supplementation on~     serum proinflammatory cytokines levels, oxidative stress markers and disease progression in~     MS.~   "
92825|NCT01842178|"~     This study is designed to evaluate the potential benefit in pregnancy rates produced by an~     endometrial scratching made in an IVF cycle prior to embryo transfer in patients with~     donated oocytes.~   "
92826|NCT01842165|"~     The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose~     uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are~     reliable predictors for lesion-by-lesion treatment outcome.~   "
92827|NCT01842139|"~     This randomized phase I trial studies the side effects and best way to give vaccine therapy~     together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete~     remission. Vaccines made from the WT1 peptide may help the body build an effective immune~     response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response.~     Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some~     block the ability of cancer to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide~     vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together~     with basiliximab in treating AML~   "
92828|NCT01842126|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a~     range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy.~     Secondary objectives of this study are to determine the single IV and SC dose~     pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of~     bioavailability by comparing SC exposure to IV exposure in each participant, to determine~     the multiple SC dose PK profiles of BG00010 in participants with painful lumbar~     radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy~     volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with~     painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain~     following multiple SC administrations in participants with painful lumbar radiculopathy.~   "
92829|NCT01842113|"~     The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction~     with the use of nutritional concepts is effective in improving morbidity and quality of life~     in cirrhotic patients suffering from hepatic encephalopathy (HE).~   "
92830|NCT01842100|"~     Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced~     abortion, and at the same time alters women's sexual behavior and prevents further~     re-infection by sexually transmitted infections when compared to the universal antibiotic~     prophylaxis strategy.~   "
92833|NCT01842061|"~     The investigators propose a 6-month, parallel, single-blind randomized controlled trial~     (RCT) feasibility study of a self-management program to reduce sedentary time and increase~     physical activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to~     determine feasibility and acceptability of the intervention; and the secondary aim is to~     test the effect of the intervention on the primary health outcome, physical activity (mean~     daily step count by accelerometry) at 6 months. The investigators will also conduct an~     economic evaluation and a process evaluation to guide a future larger study and to inform a~     scaled-up implementation plan.~   "
92834|NCT01842048|"~     The main goals of deep hyperthermia combined with external beam radiation (EBRT) on bone~     metastases are the response on pain relief, duration of response and time to achieve~     complete pain relief.~   "
92835|NCT01842035|"~     The purpose of this study is to determine whether a blunted heart rate response to~     regadenoson is an independent predictor of sudden cardiac death.~   "
92836|NCT01842022|"~     A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and~     mood, however, the data in older adults and those most prone to cognitive dysfunction, is~     limited and conflicting. One explanation is that the GL of a meal may interact with a~     person's pre-existing glucose tolerance (GT).~      As older adults have a higher incidence of glucose tolerance and are more likely to~     experience memory problems the present study considers the interaction between the GL of~     meal in those with better or poorer GT.~      The population studied will not have a history of diabetes or dementia. A battery of~     cognitive tests will be administered after meals sweetened with one of three sugars known to~     vary in the rate that they release glucose into the blood stream.~   "
92837|NCT01842009|"~     The purpose of this study is to investigate the mean number of stimulation (high~     definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a~     clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS)~     for pain. These data will be important in defining the optimal number of sessions for future~     fibromyalgia subjects in Phase III trials.~   "
92838|NCT01841996|"~     This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.~      The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics~     of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in~     adults with distal subungual onychomycosis of the toenails.~   "
92839|NCT01841983|"~     While most of the research on integrated approaches of occupational health and safety and~     worksite health promotion to date has focused on manufacturing settings, employment is~     shifting to the service sector. Within this sector, health care employs over 12 million~     workers, and is the second fastest growing industry in the U.S. economy. In contrast to~     workers in other industries, rates of occupational injuries and illnesses among health care~     workers have increased over the past decade. The purpose of this study is to lay the~     foundation for integrated interventions in health care through examination of the~     associations of worker health outcomes and risks on and off the job with work policies and~     practices and to address the prevalent issues of musculoskeletal disorders (MSDs),~     particularly low back pain disability (LBPD), and health promotions through physical~     activity among patient care workers. The specific aims of this study are:~        1. To estimate the efficacy and determine the feasibility of an integrated intervention,~          addressing both health protection and health promotion in order to reduce MSD symptoms~          and improve health behaviors among healthcare workers. We will assess between-group~          differences in MSD symptoms, health behaviors, including physical activity, and a set~          of secondary outcomes, including unplanned absence, reported injuries, worker~          compensation claims and costs, turnover and retention, intention to leave the job, and~          work-role function. This study will explore the working hypothesis that: Workers~          employed at baseline in patient-care units receiving the intervention will report~          greater reductions in their MSD symptoms (primary outcome) and greater improvements in~          health behaviors, compared with workers employed at baseline in units assigned to the~          Usual Care control group.~        2. To determine the factors in the work environment which contribute over time to~          reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work~          environment, work organization, and psychosocial factors, measured in our current~          study, will be associated with changes in workers' health behaviors and health outcomes~          between the assessments in the current and proposed studies; (2) Improvements in the~          work environment over time will be associated with improvements in workers' health~          behaviors and health outcomes. We will conduct multilevel modeling analysis to evaluate~          the simultaneous effects of worker-level and unit-level factors on MSD symptoms and~          safety and health behaviors.~   "
92840|NCT01841970|"~     Hemorrhoids are vascular cushions in the anal canal. People are normally born with~     hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids~     typically cause symptoms when they enlarge over time. There are two types of hemorrhoids-~     External Hemorrhoids and Internal Hemorrhoids.~      Current minimally invasive technologies for the treatment of internal hemorrhoids are~     associated with several drawbacks that include high rate of recurrence and a need for~     repetitive procedures, frequent post-procedural pain or significant discomfort,~     intra-operative pain and technically demanding. The purpose of this study is to determine~     whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage~     II hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device~     for the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate~     design features with the intent of resolving each of the major limitations of currently~     available technology.~   "
92841|NCT01841957|"~     To evaluate the safety and efficacy of treating visually significant bilateral cataract with~     the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the~     conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select~     patient population.~   "
92842|NCT01841944|"~     The aim of the present study is to investigate the possible effects of supplementation with~     1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality~     during a follow-up period of 2 years in an elderly population after having experienced an~     acute myocardial infarction.~      The hypothesis is that this supplementation on top of modern therapy will reduce the~     combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke and~     revascularizations with at least 30%.~   "
92843|NCT01841931|"~     The purpose of this study is to examine whether buprenorphine can be at least as effective~     as other opioid medications in relieving chronic pain in patients who suffer from dependence~     on their opioid medications, while patients simultaneously experience progressive decline of~     pain along with absence of opioid withdrawal symptoms and improved quality of life.~   "
92844|NCT01841918|"~     The purpose of this study is to evaluate immune response and safety of live attenuated~     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,~     Thailand in healthy Thais.~   "
92893|NCT01841281|"~     The major impact of this study will be to identify the adult severe asthma cohort that will~     benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of~     adult severe asthma patients will respond to supplemental L-arginine and derive clinical~     benefit from the addition of this therapy to standard-of-care asthma medications. The~     investigators hypothesize that the patients that benefit most will have low exhaled nitric~     oxide concentrations (< 20 ppb) at baseline.~   "
92845|NCT01841905|"~     The investigators are conducting a study to try to improve our ability to identify older~     adults who are at high-risk for progression to Alzheimer's disease, several years before~     they have symptoms that might reduce their quality of life. The investigators believe they~     can increase the sensitivity of tests of memory and problem solving, by using a very small~     dose of a medication (scopolamine) that reduces the activity of the principal chemical~     system in the brain that is changing in the earliest stages of Alzheimer's disease. By~     pairing this micro-dose drug challenge (that is administered with a tiny needle placed~     just under the surface of the skin on the forearm), with our tests of memory and thinking,~     it is believed that the investigators can create a stress test that is very similar in~     concept to the use of the exercise treadmill to make the results of a heart EKG more~     sensitive to detect early disease, as a cardiac stress test for heart disease. The~     investigators want to create a similar stress test for Alzheimer's disease (AD).~   "
92846|NCT01841892|"~     Methadone is effective for heroin addiction, but many methadone patients continue to use~     cocaine. High magnitude and long-duration voucher-based abstinence reinforcement, in which~     participants receive vouchers exchangeable for goods and services contingent on providing~     drug-free biological samples, is one of the most effective treatments for drug addiction and~     can maintain cocaine abstinence over extended periods of time. Our research on a model~     Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which~     participants must provide drug-free urine samples to access the workplace and maintain~     maximum pay, can maintain cocaine abstinence and reduce drug-related HIV risk behaviors over~     extended time periods. Our next challenge is to disseminate employment-based reinforcement~     for the treatment of drug addiction. The investigators propose to develop, manualize, and~     pilot test a community-friendly Therapeutic Workplace intervention that can be implemented~     widely throughout the US and elsewhere. Methadone patients who use injection or crack~     cocaine during methadone treatment will be invited to participate (N = 58) and randomly~     assigned to one of two groups: Usual Care (control) group or Community Therapeutic Workplace~     group. As in our prior implementations of the Therapeutic Workplace intervention, Community~     Therapeutic Workplace participants will enroll in Phase 1 to initiate drug abstinence and~     acquire job skills. Participants who initiate abstinence and acquire job skills in Phase 1~     will be hired into community workplaces with collaborating employers in Phase 2. During~     Phase 2, employment-based abstinence reinforcement contingencies will be implemented using~     procedures for workplace drug and alcohol testing overseen by the US Department of~     Transportation. Using this system, a national provider of Drug-Free Workplace Services will~     arrange random drug testing and employment-based abstinence reinforcement contingencies in~     which employees will be required to remain drug-free to maintain employment. The~     investigators hypothesize that participants in the Community Therapeutic Workplace group~     will provide more drug-free samples, and engage in fewer HIV-risk behaviors than~     participants in the Usual Care group. The study will provide vital information on the~     acceptability of the intervention to participants and employers, and provide preliminary~     data on the effectiveness of the investigators procedures to maintain abstinence and promote~     employment.~   "
92847|NCT01841879|"~     The investigators are designing and testing the effectiveness of an integrated tobacco~     control and occupational health (OH) intervention aimed at promoting tobacco cessation among~     workers and supporting the adoption, implementation, and enforcement of tobacco control~     policies in 20 manufacturing worksites in the greater Mumbai region of India.~   "
92848|NCT01841866|"~     Laryngeal mask airway (LMA) is widely used in children.The appropriate time to remove~     laryngeal mask airway is still inconclusive.Sore throat is one of common complications after~     general anesthesia. Sometimes postoperative sore throat affects patients' satisfaction and~     daily activities. It can be correlated with dysphagia and may limit oral intake especially~     in children.The incidence of postoperative sore throat after laryngeal mask airway insertion~     varies from 5.8-34% in adult(13) and 17.5% in pediatric.Somehow, almost the studies of~     postoperative sore throat after laryngeal mask airway removal were done in awake state. Our~     study object to test that post operative sore throat after LMA removal in deep anesthetized~     children is lower than awake children.~   "
92849|NCT01841853|"~     The aim of this research project is to evaluate a health-promoting and disease-preventive~     intervention for older foreign-born adults. The overarching goal of the intervention is to~     preserve participant's health, quality of life, and minimize their need of medical care.~   "
92850|NCT01841840|"~     Stroke is the third leading cause of death in the United States. Of those who are affected~     by stroke, a third becomes permanently disabled. Risk factors for stroke include, but are~     not limited to, advancing age, physical inactivity, arterial stiffness, and most commonly,~     high blood pressure. Stroke is a major form of a much boarder problem, cardiovascular~     disease (CVD). CVD is considered the primary cause of death in the US. Interestingly,~     increased arterial stiffness of elastic arteries (carotid and aorta) has been shown to be~     strongly correlated to CVD and stroke. Increased arterial stiffness is considered an~     independent risk for the development of CVD and stroke. Hence, arterial stiffness has been~     suggested as a potential therapeutic target for CVD and more specifically stroke.~      Recently, whole-body vibration (WBV) exercise has been proposed as a new and effective~     method to improve muscle mass and muscle strength in younger and older individuals. It is~     known that systemic arterial stiffness decreased 40 min after a single WBV session in~     healthy men. In our laboratory, we have shown that leg arterial stiffness decreases after a~     session of WBV. Taken together, this data seems to suggest WBV may be used as a viable way~     to decrease arterial stiffness. Special populations, such as post-stroke patients, may be~     unwilling or unable to perform WBV exercise so an inactive form of exercise (vibration)~     therapy is needed.~      Passive vibration (PV), allows patients to lie in an inactive, supine position, with their~     legs placed onto the vibration plate. This exposes the lower limbs to continuous vibration~     without performing voluntary muscle contraction. PV has been shown to increase skin blood~     flow on the vibrated extremity through vasodilation in healthy individuals and type 2~     diabetics. Previous work in our laboratory has demonstrated that a 10-min session of PV on~     the legs decreases augmentation index (AIx) , a marker of pressure wave reflection, as well~     as leg and systemic PWV through decreases in local peripheral resistance in young men.~     However, the effects of PV on arterial function in post-stroke patients are unknown.~      It is hypothesized that post-stroke patients will demonstrate a decrease in leg PWV and~     central AIx. However, greater responses are expected with the lower vibration frequency.~   "
92851|NCT01841827|"~     We will use Cilostazol as a tool to investigate its headache inducing effects in migraine~     patients.~   "
92852|NCT01841814|"~     The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months~     during the therapeutic management of patients with lymphoma.~   "
92853|NCT01841801|"~     To assess the safety and tolerability for the extended wear of an experimental air-activated~     self adhesive patch.~   "
92854|NCT01841788|"~     A disposable, air-activated, adhesive backed heat patch is being developed to provide~     temporary relief from minor muscular ache and joint pains associated with overexertion~     strains and sprains as well as minor pain associated with arthritis. The aim of the study is~     to determine the safety and tolerability of the patch during normal wear conditions.~   "
92855|NCT01841775|"~     Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3~     patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks,~     and the verification of sustained virological response at week 48.~      The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic~     Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:~      http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf~   "
92912|NCT01841034|"~     Male infertility is a multifactorial disease process with a number of potential contributive~     causes. Considering the majority of male infertility cases are due to deficient sperm~     production of unknown origin, environmental and nutritional factors must be evaluated. The~     purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement~     (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile~     men with oligoasthenozoospermia.~   "
92856|NCT01841762|"~     SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric~     validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with~     pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of~     which they will receive macitentan, 10 mg, once daily.~      The primary objectives are to demonstrate the final content validity of the PAH SYMPACT~     instrument, to demonstrate the psychometric characteristics of reliability and construct~     validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT~     instrument to detect change. The secondary objective is to assess the safety of macitentan~     in patients with pulmonary arterial hypertension. The exploratory objective is to explore~     the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT)~     in patients with pulmonary arterial hypertension.~   "
92857|NCT01841749|"~     The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and~     a mastectomy indication will be obtained by calculating the proportion of women with GAS~     in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of~     95% will be deferred.~   "
92858|NCT01841736|"~     This randomized phase II trial studies how well pazopanib hydrochloride works in treating~     patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
92859|NCT01841723|"~     This phase II trial studies how well ibrutinib works in treating patients with hairy cell~     leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
92860|NCT01841710|"~     This proposal describes a pilot study aimed at determining whether genetic variations in~     taste receptors determine differential taste tolerability of pediatric medications.~   "
92861|NCT01841697|"~     This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with~     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The~     primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c~     (A1C) in participants treated with omarigliptin is non-inferior to that in participants~     treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin~     prior to the double-blind treatment period.~   "
92862|NCT01841684|"~     This study will evaluate the safety and effect of anacetrapib on low-density~     lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary~     hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a~     greater extent than treatment with placebo.~   "
92863|NCT01841671|"~     The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV,~     two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to~     provide evidence for better immunization policy making in regions of the world that must~     switch to use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the~     best option optimizing humoral immune responses, intestinal immunity and thereby prevent~     community transmission as well as preventing VAPP. Specifically, the study seeks to show~     that both of the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen~     in the seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10%~     of subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen~     and the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the~     3-dose IPV regimen. In addition, the study will evaluate by a novel method (poliovirus~     shedding index), the adequacy of IPV vaccines in inducing intestinal immunity, specifically~     by reducing the shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the~     study are:~        -  A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in~          terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.~        -  Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to~          type 2 poliovirus and sufficient priming to induce a rapid immune response in the~          context of an oral challenge at 7 months of age.~        -  Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type~          2 as measured by a combination of quantity of virus in stools and duration of shedding~          (shedding index).~      In addition to these 3 hypotheses, the study will explore the following hypothesis:~      • Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose)~     provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects~     receiving rotavirus vaccine together with IPV.~   "
92864|NCT01841658|"~     The objective of this study is to identify genes whose expression is potentially modifiable~     due to changes in folate intake and help delineate mechanisms accounting for the variability~     in individual response to folic acid supplementation. The study will be conducted in normal~     weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic~     acid.~      It is hypothesized that (1) a change in folate status, induced by the supplementation, will~     influence the DNA methylation of specific genes and (2) the DNA methylation response to~     folic acid supplementation may differ between the normal weight and the obese women of~     childbearing age.~   "
92865|NCT01841645|"~     The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA)~     from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion~     study was carried out with healthy volunteers. CLA depletion was achieved through an~     eight-week dairy fat restriction, followed by an eight-week repletion period consisting of~     intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose~     and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and~     fatty acid composition of lipid classes are evaluated after depletion and repletion phases.~   "
92866|NCT01841632|"~     MultiStem ® is a new biological product, manufactured from human stem cells obtained from~     adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune~     system function and augment tissue repair.~      Standard of care pharmacological immunosuppression after liver transplantation can achieve~     reasonable survival of liver grafts and patients. The side effects of this treatment,~     however, are clinically significant and diminish the overall success of organ~     transplantation as a curative therapy. It is therefore the objective of this study to~     implement cellular immunomodulation therapy with MultiStem as an adjunct to standard~     pharmacological immunosuppression with the ultimate goal of significantly reducing~     drug-based immunosuppression.~      As this is the first study with MultiStem in this subject population it has been designed as~     a safety and feasibility trial. However, first evidence of a potential benefit for this~     patient population will be explored cautiously.~   "
92867|NCT01841619|"~     The purpose of this research study is to show that non-steroidal treatment with intravenous~     immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous~     lupus erythematosis (CLE) patients.~   "
92868|NCT01841606|"~     Ondansetron is a medication routinely given to mothers having cesarean deliveries to help~     prevent and treat nausea and vomiting. The investigators are studying the hemodynamic~     effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries~     under spinal anesthesia.~   "
92869|NCT01841593|"~     The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the~     blood, and how it is affected if raltegravir is taken at the same time as another medicine~     for high blood pressure (amlodipine). Many patients with HIV will also have high blood~     pressure, so it is important to know which drugs for each of these conditions can be taken~     together without affecting how well they work individually.~      Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,~     with the middle week being on both drugs. The investigators will look at and compare the~     levels of these two drugs in the blood after subjects have taken them separately and both~     together.~      This study is randomised into two groups with both study medications received by all~     participants in a three-period crossover pattern; randomisation determined which medication~     was taken first. Once randomised allocation was performed, medications were administered in~     an open-label fashion.~   "
92870|NCT01841580|"~     Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million~     have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk~     factor in glaucoma, and reducing intraocular pressure to a consistently low level can delay~     disease progression and therefore, blindness.6 Topical intraocular pressure -lowering~     medication remains the first-line treatment for glaucoma, with surgical intervention playing~     a secondary role in cases suboptimally controlled with medication alone.~      In this study, we plan to assess the change in tear proteins in trabeculectomy patients~     before and after operations. It is hoped that this study could help us gain more~     understanding of the possible mechanism accounting for the development of dry eye disease in~     glaucoma patients, which could help us develop better screening modalities and therapeutic~     agents for glaucoma patients at risk to prevent the development of dry eye disease.~   "
92871|NCT01841567|"~     The overall rationale for this study is to evaluate the clinical performance potential for~     Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and~     less dressing change due to high absorption capacity. This study is a part of Post Market~     Clinical Follow-Up (PMCF).~   "
92872|NCT01841554|"~     To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for~     repair of functional mitral regurgitation.~   "
92873|NCT01841541|"~     Training and engaging of unpaid informal providers (such as tea-sellers, women's groups,~     youth clubs, small traders and religious groups) from poorer localities in TB disease~     recognition, referral and community awareness raising will increase the access of TB~     patients to formal health facilities and decrease their delay in initiating TB treatment.~   "
92874|NCT01841528|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of~     childbearing age. However, the optimal infertility treatment for PCOS patients is still a~     matter of controversy. Despite producing more follicles and more oocytes than other women~     undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have~     comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF~     have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be~     aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS~     are thought to have higher rates of later pregnancy complications including spontaneous~     abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in~     the superovulated endometrium. We propose a randomized clinical trial of elective embryo~     cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo~     transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro~     fertilization (IVF).~   "
92875|NCT01841515|"~     Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in~     CKD patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin~     (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by~     in vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in~     vitro platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The~     investigators designed a prospective study to evaluate the effect of desmopressin on~     platelet function, as measured by in vitro collagen/epinephrine - closure time, in uremic~     patients who were taking antiplatelet drugs.~   "
92876|NCT01841502|"~     Hepatitis C (HCV) infected patients are often in need for an antidepressant. The~     introduction of Direct Acting Antivirals such as telaprevir has greatly improved treatment~     outcome of HCV infected patients.Telaprevir has been studied with one antidepressant,~     escitalopram: plasma concentrations of the antidepressant were reduced by 35% and without~     dose adjustment this may lead to inadequate treatment of depressive symptoms. There is a~     need for more data on telaprevir drug interactions with other antidepressants.~      For a number of reasons, paroxetine may be a good candidate for use together with~     telaprevir-containing HCV treatment.~      The interaction between paroxetine and telaprevir has not been studied before.~   "
92877|NCT01841489|"~     This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to~     Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on~     GS-9973 Pharmacokinetics.~   "
92878|NCT01841476|"~     Phase I study to determine and compare the safety/tolerability of single ascending doses of~     POL6326 by intravenous infusion.~   "
92879|NCT01841463|"~     -  An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05~          Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with~          Advanced or Inoperable Malignant Melanoma with BRAF Mutation~        -  The primary objective is to determine the safety, maximum tolerated dose (MTD), and~          dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in~          melanoma patients with BRAF mutation~   "
92880|NCT01841450|"~     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®~     Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract~     surgery only, in subjects with mild to moderate open-angle glaucoma.~   "
92881|NCT01841437|"~     The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular~     Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild~     to moderate open-angle glaucoma.~   "
93165|NCT01837732|"~     The aim is to investigate the feasibility and efficacy of a relational touch / relational~     intervention on persistent pain in a long term geriatric hospital care ward population. The~     main issue is the pain reduction. The hypothesis is that this type of intervention is very~     useful on pain reduction in old people even with physical or mental disability.~   "
92882|NCT01841424|"~     Obesity is becoming more common and disproportionately affects the younger generation, the~     poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or~     overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders,~     stillbirth, less successful breastfeeding, obesity in their offspring, postpartum~     depression, and higher weight retention postpartum. Dietary counseling can prevent excessive~     maternal weight gain and is more effective than activity-based interventions. The two~     objectives of this study are 1) to use community-based techniques to improve dietary~     counseling for high risk women and 2) to randomize obese women to dietary counseling at~     Truman Medical Center and measure their success. The hypothesis is that dietary~     interventions can successfully be tailored for high risk women and that excessive weight~     gain during pregnancy can be avoided.~   "
92883|NCT01841411|"~     N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and~     antibacterial properties, and is produced within the human body.Its effect in biofilms has~     been tested in several bacteria. Biofilms have recently been observed in 90% of subjects~     with bacterial vaginosis (BV) with Gardnerella vaginalis being the predominant species.~     Although a wide range of antimicrobial agents are currently available, treatment options for~     controlling BV are still limited. Furthermore, the number of relapses are increasing and~     require alternative treatments. This study is aiming to evaluate the role of NAC in~     treatment of BV and prevention of recurrence.~   "
92884|NCT01841398|"~     People who originate from the Indian subcontinent known as South Asians are the fastest~     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,~     type 2 diabetes and heart disease. They also develop these risk factors at significantly~     lower body weight and at younger ages compared to people of European origin. The purpose of~     SAHARA (South Asian HeArt Risk Assessment) Trial, is to recruit 330 South Asians from~     Ontario (Principal Investigator: Dr. Sonia Anand) and British Columbia (Co-investigator: Dr.~     Scott Lear), who use the internet, email and other multimedia devices. Among these~     participants, the investigators will compare the effectiveness of a 12-month interactive~     multi-media health behaviour intervention to usual care in reducing cardiac risk factors.~     This intervention enables participants to set their health goals and provides health~     messaging and feedback designed to improve their smoking, dietary habits and physical~     activity. In addition, the investigators will test if knowledge of genetic risk for heart~     attack influences behaviour change and their heart health risk factor profile. The~     information generated from SAHARA will enable individuals, physicians, health professionals,~     and policy makers to develop risk factor modification programs to prevent cardiovascular~     disease in this high-risk group.~   "
92885|NCT01841385|"~     The aim of this study was to evaluate the influence of a fitness program from the~     application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle~     strength in women.~   "
92886|NCT01841372|"~     The purpose of this study is to determine if use of a virtual reality platform, Second Life,~     is more effective than traditional face-to-face methods for maintaining weight loss in~     overweight and obese individuals.~   "
92887|NCT01841359|"~     The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce~     the frequency and severity of hypoglycemia in individuals who have had gastric bypass~     surgery.~   "
92888|NCT01841346|"~     The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in~     consecutive patients who undergo stent implantation and angioplasty in Jordan.~   "
92889|NCT01841333|"~     This phase II trial will test whether the Hedgehog signaling pathway inhibitor PF-04449913~     can decrease disease relapse in high-risk patients with acute leukemia after donor stem cell~     transplant.~   "
92890|NCT01841320|"~     This research examines the effectiveness of an intervention that employs seek, test, and~     treat strategies for Vietnamese injection drug users (IDU) and their network members, by~     ensuring that high risk individuals are sought for HIV testing and promptly referred to and~     maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to~     IDUs who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will~     be referred to HIV care through a two-arm randomized controlled trial to compare the effects~     of different levels of engagement in care on ART uptake, ART adherence, and treatment~     outcome.~   "
92891|NCT01841307|"~     The overall purpose of this project is to develop and validate a simple, non-invasive method~     to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient~     setting, the investigators will compare the quantity of cromolyn detected in urine collected~     overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn~     sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6~     either awaiting or recently undergone lung transplantation) with clinical and laboratory~     evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting,~     the investigators will compare the quantity of cromolyn detected in urine collected~     overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn~     sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently~     undergone lung transplantation) with clinical and laboratory evidence of GER~     (gastroesophageal reflux) with microaspiration.~   "
92892|NCT01841294|"~     Surgical resection is the best treatment option for colorectal cancer. Despite this radical~     approach, recurrences within five years are still common. Several authors have proposed that~     the immunosuppressive state surrounding the perioperative period was a key element of cancer~     cells spread.~      A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of~     the innate immune system. Several factors of the perioperative period can reduce activity of~     NKs such as stress, pain, opioids and general anaesthetics.~      Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal~     surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption,~     ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic~     inflammation as well.~      The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries~     for colorectal cancer resection will preserve NKs activity.~   "
92913|NCT01841021|"~     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in~     patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects)~     of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied.~     It is not known if brentuximab vedotin is better or worse than other treatment patients~     might be given.~   "
92894|NCT01841268|"~     This study is designed to compare the skin lipid and protein composition between term and~     premature infants and determine how the skin composition changes over the first four weeks~     of life. The investigators hope to elucidate the unique characteristics of premature skin by~     measuring the lipid and protein content in skin, how it changes during the first month of~     life, and how it varies with formula feeding versus breast feeding. Additionally, the~     investigators will study the relationships among diet, skin composition and plasma lipids in~     premature infants over the first four weeks of life.~   "
92895|NCT01841255|"~     Background - Preoxygenation is performed before general anesthesia to increase the oxygen~     reserves of the body and prolong the safe period of apnea without hypoxia. However, it is~     often impossible to obtain a perfect face mask fit, and optimal end-tidal fractional oxygen~     concentration (EtO2) are not attained. The investigators designed a new oropharyngeal~     preoxygenation device, UMOX™, to avoid leaks during preoxygenation. In this study, the~     investigators compared the efficacy of UMOX™ with that of a conventional face mask.~      Methods - In 50 healthy volunteers breathing 100% oxygen from a circle absorber system for a~     5 minute-period, the investigators compared preoxygenation using the 1) a conventional mask;~     2) UMOX™ without any instruction; 3) UMOX™ with instruction on mouth breathing; and 4) UMOX™~     with a nose clip, in random order. Each subject underwent all steps with a 10-minute rest~     period of room air breathing between each step. Inspired and end-tidal respiratory gases~     were measured every 10 seconds. EtO2 variation was analyzed using Anova.~   "
92896|NCT01841242|"~     Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long~     term despite the use of many effective drug treatment in reducing morbidity and mortality.~     In this context, cardiac resynchronization (CR), either alone or combined with a~     defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this~     population of patients with heart failure. The information on the CR are now well~     established for patients with stage III-IV NYHA (New York Heart Association), with systolic~     dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when~     medical treatment is optimal. As a result, the number of implanted devices continue to grow~     even if the implant procedures of cardiac resynchronization devices (CRD) are long,~     difficult and associated with significant complications with a risk of reoperation estimated~     between 10 and 15% . One of the most feared during implantation devices stimulation or~     defibrillation risk is represented by the risk of infection that will lead inevitably to~     explantation of the device. Despite the use of several preventive measures, including the~     use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI~     5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly~     demonstrated that the risk of infection was associated with the duration of the intervention~     and was higher for procedures CR, it is noted in 2.4% in the short term and would be close~     to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor~     prognosis, even in an excess mortality. It has been shown that the majority of infections~     may be linked to local contamination during surgery reinforcing the idea that prevention is~     mainly based on local measures and the reduction of operating time.~   "
92897|NCT01841229|"~     Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive~     hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting~     glucose, fasting insulin, and the homeostasis model assessment of insulin resistance~     [HOMA-IR]).~   "
92898|NCT01841216|"~     The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the~     treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises~     which activate the Gmed and Gmax, but limited research remains on exercises involving~     resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and~     TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in~     healthy and low back pain patients while performing exercises with and without resistance.~     Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular~     low back pain will be recruited. Exclusionary criteria will include: current low back or~     lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular~     symptoms. Surface electromyography will be used to quantify the activity level of the~     gluteal muscles and TFL while performing a series of 8 exercises with and without~     Thera-Band® Resistance Tubing and Stability Trainer. The maximal voluntary isometric~     contraction (MVIC) will be established for each muscle group and the order of exercises~     performed will be randomized to minimize the effect of fatigue. Following the completion of~     each exercise, the patient will rate their perceived exertion level on the Thera-Band®~     Resistance Intensity Scale for Exercise (RISE). The EMG signals will be smoothed and~     rectified and analyzed using a root-mean-square algorithm. Clinical Relevance: The results~     of this study will allow clinicians to better prescribe exercises, proven to activate the~     gluteal muscles and limit the TFL involvement, in the treatment of low back pain.~   "
92899|NCT01841203|"~     A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was~     developed for the diagnosis of infections with T. pallidum. The assay is designed for use in~     resource-limited settings where challenging conditions (such as lack of electricity, running~     water, or laboratory equipment) commonly exist. We sought to compare performance of the~     dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference~     standards.~   "
92900|NCT01841190|"~     The purpose of this study is to compare the tendency of plasma concentration and clearance~     of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis~     and septic shock with another marker of early prognosis represented by 48 hours delta sofa.~   "
92901|NCT01841177|"~     Children with congenital heart disease have significant morbidity including low cardiac~     output syndrome and subsequent organ dysfunction that may be prevented by optimization of~     circulatory function. More than half of these children receive milrinone. Clinical~     evaluation cannot distinguish between patients with sub-therapeutic, therapeutic, and toxic~     milrinone drug levels. Consequently children who require pharmacologic circulatory support~     may be receiving sub-optimal dosing, and children who do not need milrinone may be receiving~     milrinone unnecessarily. The primary objective of this study is to determine if optimizing~     milrinone levels with therapeutic drug monitoring in critically ill children following~     cardiac surgery improves clinical outcomes and reduces the duration of milrinone infusion.~     This study hypothesizes that optimizing milrinone levels with therapeutic drug monitoring in~     critically ill children following cardiac surgery will improve clinical outcomes and reduce~     the duration of milrinone infusion.~   "
93016|NCT01839682|"~     This post-market surveillance research project consists of data collection at specified time~     points using standard questionnaire instruments to compare pain level, mobility and function~     pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and~     StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral~     compression fractures.~   "
92902|NCT01841164|"~     The trial is an investigator-driven research study in subjects with intermittent asthma, the~     aim of which is to explore the likelihood of a functionally important separate leukotriene~     E4 (LTE4) receptor in airways and/or inflammatory cells in human subjects with asthma.~      Mostly on the basis of experiments in mice models, the prevailing view suggests that the~     present class of anti-leukotriene drugs are insufficient because they do not block the~     pro-inflammatory and bronchoconstrictive effects of LTE4. It is established by us and other~     groups that LTE4 is the most stable and long-lived leukotriene.~      The study will establish the effect of oral treatment with the highly selective~     CysLT1-receptor antagonist, montelukast, on bronchial responsiveness to inhaled LTE4 in~     subjects with intermittent asthma~   "
92903|NCT01841151|"~     The purpose of this study is to investigate if neurofeedback and working memory training~     improves core symptoms of ADHD in children and adolescents.~   "
92904|NCT01841138|"~     Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have~     significant changes of serum electrolytes.~      A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount~     of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal~     results. Ingestion of a high volume of free water bears a risk for severe changes of serum~     electrolytes, particularly for sodium and potassium.~      In this trial, patients undergo regular bowel preparation for standard colonoscopy with~     Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient~     cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium,~     phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure~     and right before colonoscopy. The interval between both blood samples that will be compared~     is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is~     recorded. The quality of bowel preparation is visually rated during colonoscopy with a~     validated score.~      Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the~     proportion of patients who have a serum sodium beyond the reference values after the~     completion of bowel preparation. Secondary outcome parameters are the proportion of patients~     with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of~     serum electrolytes and osmolarity will be correlated with the amount of prep solution and~     liquid.~   "
92905|NCT01841125|"~     Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in~     Alzheimer's Disease~      Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial~     with an open-label, 12-week extension~   "
92906|NCT01841112|"~     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306~     tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in~     the study protocol.~   "
92907|NCT01841099|"~     Undernutrition is one of the most important health issues in Kenya. Children who are~     chronically undernourished do not reach their full potential and are at increased risk of~     infectious disease. Stunting occurs in a third of Kenyan children and has severe and~     long-term consequences in terms of health, development, and poverty. Several studies have~     shown that stunting is frequently associated with subclinical inflammation of the bowel, a~     condition referred to as Environmental Enteropathy (EE), previously known as 'tropical~     sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel~     diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision~     of gut immunomodulatory agents, but this approach has never been tried in EE.~      This proposal outlines a pilot double-blind randomised placebo-controlled trial of~     mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least~     systemic activity) in treatment of severely malnourished children with EE.~   "
92908|NCT01841086|"~     The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate~     controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and~     Food effect on the pharmacokinetics of sarpogrelate CR.~   "
92909|NCT01841073|"~     The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading~     to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and~     diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in~     individuals with IGT by reducing appetite and food intake, and improving insulin~     sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is~     full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short~     chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the~     intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres~     in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta~     cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of~     free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant~     subject's leads to improved insulin sensitivity. This body of work will examine the effect~     of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give~     an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in~     this at-risk group.~   "
92910|NCT01841060|"~     Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are~     not operable because of their condition or respiratory problems associated with it. The~     treatment is then suggested that local radiotherapy is conventionally carried out in split~     mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to~     complications, including post-radiation pneumonitis.~   "
92911|NCT01841047|"~     Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is~     locoregional.~      In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of~     the surgical resection. The effect of radiotherapy combined with surgery is uncertain and~     until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy)~     due to high risk of organ toxicity nearby.~      The helical tomotherapy is an innovative equipment radiotherapy to make conformational~     radiotherapy modulation intensity and is particularly suitable for irradiations precision~     (imaging mode associated with daily scanner) in large complex volumes. Increasing doses~     (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical~     tomotherapy should allow to improve the efficacy of radiotherapy.~   "
93166|NCT01837719|"~     The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir~     in a fixed-dose combination with cobicistat with that of atazanavir coadministered with~     cobicistat as single agents.~   "
92914|NCT01841008|"~     Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many~     prospective studies. Prospective randomized studies versus placebo are required to confirm~     the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1%~     per week can reduce relapses of non-segmental vitiligo lesions.~      Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs~     placebo in the prevention of depigmentation in patients with vitiligo who responded to~     treatment.~      Secondary objectives~        -  Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to~          decrease the intensity of depigmentation in patients with vitiligo who responded to~          treatment.~        -  To study the occurrence of possible adverse effects.~      Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total~     length of the study: 18 months~      Intervention Multicentric prospective interventional randomized comparative study versus~     placebo.~        -  Visit V0: Selection Information of the patient, control of inclusion and non inclusion~          criteria.~        -  Visit V1: Control of inclusion and non inclusion criteria, patients signed informed~          consent. An initial clinical evaluation and photographs in direct sunlight and UV.~          Topical treatment (tacrolimus or placebo) will be delivered to the patient by the~          hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24~          weeks.~        -  Visit V2:~      The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for~     final evaluation. A clinical assessment will be made and photographs in the same way as the~     inclusion. Adverse reactions during treatment will be collected by the investigator (they~     will be noted as and when the patient in a notebook that will be presented at baseline).~      The percentage of depigmentation will be evaluated in a blinded treatment of photographs by~     two reviewers. In case of disagreement, the opinion of a third appraiser will be required.~      - End of study: After the end of the study patients will be supported via the usual care~     recommended for their condition.~      Evaluation criteria~        -  primary endpoint~           ---Percentage of patients at 24 weeks without depigmentation (depigmentation score =~          0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of~          direct light and UV photographs will be made by two independent observers~          (dermatologists) between inclusion and after 24 weeks of treatment.~        -  secondary endpoints~           ---- The efficiency to reduce the intensity of relapses will be evaluated using the~          score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the~          VASI score (Appendix 4).~        -  The frequency, severity and time of occurrence of adverse events are reported. Side~          effects are classified into grades according to WHO criteria.~      Number of subject Considering that depigmentation occurs in more than 40% of patients during~     the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the~     rate of depigmentation of 10%, a population of 26 patients per group will be necessary~     (taking into account 10% of patients lost to follow). The total number of patients to be~     included in the study will be 52.~   "
92915|NCT01840995|"~     The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has~     the potential to cause an increase of intracranial pressure (ICP). Previous studies have~     proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD)~     correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased~     ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.~   "
92916|NCT01840982|"~     This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical~     trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic~     index(GI) in healthy males.~   "
92917|NCT01840969|"~     This study is aimed to evaluate the association of common carotid artery circumferential~     strain with the echocardiographic parameters of left ventricular function and the degree of~     actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary~     artery bypass with preserved left ventricular ejection fraction.~   "
92918|NCT01840956|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in~     the creation of vascular access for dialysis.~   "
92919|NCT01840943|"~     The purpose of this study is to compare the effectiveness between CAELYX and topotecan~     hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma~     following failure of first-line, platinum-based chemotherapy, who have received no more than~     one prior platinum-based regimen therapy.~   "
92920|NCT01840930|"~      Cohort CP  is a multicentre cohort study, initiated by the Hospices Civils de Lyon in~     September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS~     IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the~     rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological~     and environmental data.~      The primary objective is to establish the incidence of orthopaedic complications (scoliosis~     and hip joint) depending on patients' age.~      Secondary objectives are to describe the sequences over time of these complications and the~     related pain, to explore the impact of nutrition, surgery, asymmetric postures and~     environmental factors, and to describe the medical and rehabilitative follow-up of these~     patients.~      385 patients are expected by the end of 2016. We expect of this long-term follow-up to gain~     tools that permit to improve patient's care and patient's quality of life, by putting in~     place preventing actions and adapted treatments related to their own pathologies.~   "
92921|NCT01840917|"~     The purpose of this study is to investigate heart rate variability during Acute~     uncomplicated diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the~     inflammation causes a decrease of High Frequency(HF)-power component of heart rate~     variability and this correlates with sleep quality and daytime fatigue.~   "
92922|NCT01840904|"~     The purpose of this study is to investigate subjective sleep quality and fatigue during and~     after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The~     investigators hypothesis is that subjective sleep and fatigue are correlated with the~     inflammatory activities.~   "
92923|NCT01840891|"~     The objective of this study is to determine the prevalence of secondary lactose intolerance~     in renal transplant recipients (RTR) with chronic norovirus infection.~      In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University~     Hospital of Zurich, the investigators are currently aware of 10 patients with chronic~     norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis~     of recent stool samples, whereas chronic virus shedding is defined as more than two PCR~     positive samples in an interval of at least one month. Concomitant viral (other than~     norovirus), bacterial or parasitic (particularly Gardia lamblia) intestinal infections are~     excluded by negative stool cultures and PCR analyses, respectively. Main exclusion criterion~     for the present case series is a concomitant intestinal infection (other than norovirus) and~     primary lactose intolerance, which is previously excluded by absence of the CC genotype of~     the DNA variant -13910 T/C upstream in the LCT gene. After obtaining written and oral~     informed consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a~     lactose tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection~     irrespective of current abdominal symptoms.~      The study population (N=10) is divided into two groups according to the gastrointestinal~     symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal~     discomfort). The investigators chose the cut-off three or more stools per day as indicative~     of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic~     diarrhoea but absent norovirus infection serve as control group (N=10).~   "
92924|NCT01840878|"~     The purpose of this study is to investigate the accuracy of actigraph measured sleep~     compared to the golden standard (polysomnography) during Acute uncomplicated diverticulitis.~     Our hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients~   "
92925|NCT01840865|"~     The beneficial effect of daytime sleep on memory consolidation has been shown in young,~     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory~     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity~     typically occuring during SWS has been implicated in the consolidation effect. In this study~     we investigate if the consolidation effect can be amplified by the application of a weak~     transcranial oscillatory electric current within the frequency range of SWS in humans~     (0,7-0,8 Hz) during daytime SWS.~   "
92926|NCT01840852|"~     The purpose of this study is to investigate sleep disturbances during Acute uncomplicated~     diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes~     REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.~   "
92927|NCT01840839|"~     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is~     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its~     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory~     representations. This impact of sleep on memory performance can be additionally enhanced by~     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the~     frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in~     young, healthy subjects. If older adults that commonly experiencing cognitive decline,~     including long-term retention of declarative memory - benefit from transcranial slow~     oscillatory stimulation (tSOS) during sleep in the same way has not been studied so far. The~     primary goal of the study is therefore to investigate the impact of oscillating current~     stimulation (tSOS) during a daytime nap on declarative memory consolidation in older adults.~   "
92928|NCT01840826|"~     Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who~     received the RED were 30% less likely than patients receiving usual care to access inpatient~     or emergency services within 30 days of discharge. In this project, the investigators add a~     new dimension to RED by integrating screening, referral and treatment for depression into~     the original RED intervention and determining if this enhanced intervention increases the~     effectiveness of RED in preventing readmissions and controlling costs in the 180 days after~     discharge for patients with signs of depression.~   "
92929|NCT01840813|"~     Administration of intraumbilical misoprostol to women with retained placenta despite active~     management of third stage of labour reduces the need for manual removal of placenta and the~     amount of blood loss vaginally.~   "
92930|NCT01840800|"~     Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional~     femoral/sciatic block combinations effectively reduce postoperative pain, but results in~     considerable motor blockade. The investigators aimed to evaluate postoperative pain relief~     and the degree of motor block with block combinations of femoral nerve (FEM) and obturator~     [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks~     with isotonic saline. All patients received standard patient controlled analgesia with~     morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB~     approval, 81 patients were planned to be randomized to one of three USG block combinations:~     Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used~     for all active blocks following induction of general anaesthesia [propofol-remifentanil,~     laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours~     postoperatively at rest.~      Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time,~     motor abilities of daily living scores [modified Barthel/100 index], perceived ill health~     [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].~   "
92931|NCT01840787|"~     As new contact lens products continue to be developed and improved, it's becoming harder for~     some individuals to tell whether one product is different from another. In addition, not~     everyone has the same level of sensitivity of their eyes, making it difficult for these~     judgments to be made. The purpose of this study is to explore the idea of using a~     pre-determined expert panel of individuals who are able to tell differences between~     contact lenses based on their comfort.~   "
92932|NCT01840774|"~     The purpose of this study is to determine how pain relief is modified when the investigators~     combine the Virtual Reality based Snow World game with certain pain medications.~   "
92933|NCT01840761|"~     Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid~     hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can~     cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral~     infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative~     delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is~     no standard clinical treatment programs, limiting the advantages and characteristics of~     traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's~     Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80~     times craniotomies and surgical interventions , with a rich source of patiengs to carry out~     the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang~     syndrome and comprehensive treatment programe of the State 1995,the 15th research , in~     accordance with characteristics of the pathophysiology and understanding of cause and~     pathogenesis in aSAH perioperative period , through expert advice and review of the~     literature, under the guidance of Liu Maocai who isChinese medicine practitioners of~     Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other~     aspects of efficacy evaluation, developmenting a standardized treatment program of delayed~     CVS after aSAH . To evaluate the efficacy of the standardized program by prospective,~     randomized,controlled clinical trial,improving the postoperative results, reducting~     significantly the mortality and morbidity patients with cerebral aneurysms.~   "
92952|NCT01840514|"~     The stress of orthotopic living donor liver transplantation in patients with cirrhosis could~     induce worsening of an already recorded myocardial dysfunction or may be associated with a~     new myocardial dysfunction in patients previously having normal myocardial functions,~     therefore this study will be designed for intra-operative detection of new onset ventricular~     dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver~     transplant recipient and the possible contribution of several hemodynamic and oxygenation~     parameters in the generation of any cardiovascular function impairment will be also~     investigated and to determine the impact of ventricular dysfunction on early (7 PO days)~     graft function, 28 days survival and patient outcomes.~   "
92934|NCT01840748|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and several internal organs.~      Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary~     vascular resistance, which leads to right ventricular failure. Despite being recently the~     object of greater attention and despite therapeutic advances, pulmonary hypertension due to~     SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients~     prospectively followed in the European League Against Rheumatism Scleroderma Trials and~     Research (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some~     previous data have suggested the protective effects of calcium channel blockers on the~     development of pulmonary hypertension, the potential preventive effects of vasodilators for~     the prevention of Pulmonary hypertension have not been determined yet. In addition to be~     considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids,~     endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also~     be used for this indication.~      This observational trial is one out of five observational trials of the collaborative~     project To decipher the optimal management of systemic sclerosis (DeSScipher).~      Aim of this observational trial is:~      - to compare the outcomes of adult and juvenile SSc patients who are at high risk of~     developing pulmonary hypertension and are receiving either different vasodilator treatments~     or no vasodilator treatment.~   "
92935|NCT01840735|"~     This study will determine the safety, tolerability, and pharmacokinetics of a single dose of~     GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.~   "
92936|NCT01840722|"~     The overall aim of this study is to reduce risk behaviors and increase health and behavioral~     health service utilization among disadvantaged, drug-using rural women at high risk for HIV~     and HCV. This project has potential to make a significant contribution to science by~     providing knowledge about the health, risk behaviors, and service utilization of a~     vulnerable and understudied group of women during a time of emerging and significant public~     health risk in a rural Appalachian setting. Successful completion of the aims of this~     project will advance the delivery of a low-cost, potentially high impact intervention with~     implications for a number of other real world settings (such as criminal justice venues)~     where other disadvantaged high-risk drug users can be identified and targeted for~     intervention.~   "
92937|NCT01840709|"~     Psychosomatic is a new approach to understanding the phenomena of somatization using the~     knowledge of medicine and psychology to treat human being. A Brief Group Psychanalytic~     Psychotherapy (BGPP) for psychosomatic patients has been used to supplement the treatment of~     some diseases including Systemic Lupus Erythematosus (SLE). The hypothesis of the study is~     that BGPP beside clinical treatment can improve the quality of life and coping in SLE~     patients. The aim of the study is to evaluate the effectiveness of BGPP in Brazilian SLE~     patients.~      Primary objective: To evaluate the effectiveness of BGPP to improve quality of life.~     Secondary objectives: To evaluate the effectiveness of BGPP to improve coping, anxiety and~     depression symptoms. SLE patients will be randomized to receive Psychotherapy or only~     clinical treatment. The effectiveness will be assessed through specific questionnaires.~   "
92938|NCT01840696|"~     Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal~     blood flow to the heart secondary to narrowing of the heart vessels.~      Phase analysis is a computer method that is applied after the PET test is done. It is used~     to determine when a region of the heart contracts relative to other heart regions in the~     heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow~     change the pattern of contraction from rest to stress conditions. That is, regions of the~     heart with abnormal blood supply become dyssynchronous when compared to the normal regions~     of the heart.~      This study will investigate whether phase analysis may aid the visual interpretation of~     rubidium myocardial perfusion PET studies by determining the areas of the heart that are not~     beating in synchrony with the normal heart regions. This information will be used as a proxy~     for poor blood supply. The gold standard will be coronary angiography by which the percent~     narrowing of the heart vessels is assessed.~   "
92939|NCT01840683|"~     This is an open-label, single center clinical investigation to evaluate the efficacy and~     safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a~     treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14~     clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments~     (to be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be~     performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36~     weeks and 52 weeks after the final H.E.L.P. therapy session.~   "
92940|NCT01840670|"~     The elliptic shape of inferior vena cava (IVC) sections, while hindering the ultrasound~     measurement of IVC diameter, may provide a useful tool to estimate central venous pressure~     (CVP). Hypothetically, the higher is CVP and more the ratio R between minimum and maximum~     diameters approximates 1. The purpose of this study is to determine R values in four~     different sections before and after a fluid load test, in order to evaluate if R is affected~     by the test and at which level the variation is larger.~      The secondary endpoint is to search for the parameter best predictive of the positivity of~     the fluid load test among IVC minimum and maximum diameters, eccentricity, section area, and~     blood velocity at the level that presented the largest variations after the fluid load.~   "
92953|NCT01840501|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what~     the body does to the medication), potential immunogenicity (ability to induce an immune~     response), and pharmacodynamics (what the drug does to the body) after administration of~     JNJ-42721458 in healthy adult male participants.~   "
92954|NCT01840488|"~     The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat~     (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or~     metastatic breast cancer with disease progression after prior hormonal therapy.~      This study is designed to provide necessary information on safety and dose response of~     BN83495, when given by repeated once daily oral administration, while achieving a maximal~     STS inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data~     obtained will be used to plan further clinical studies.~   "
93167|NCT01837706|"~     The purpose of this study is to observe whether people would report being less likely to sue~     a physician who shows more empathy when giving a patient potentially bad news regarding~     their medical condition.~   "
92941|NCT01840657|"~     X-Linked myotubular myopathy (XLMTM), a form of centronuclear myopathy (CNM) is the result~     of a mutation in the MTM1 (myotubularin) gene which leads to altered myotubularin.~     Myotubularin is essential for optimum muscle function. To date, over 100 mutations have been~     described resulting in a range of disease onset and symptom severity. The early onset form~     presents with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing~     requirement for continuous ventilatory support with the inability to maintain a sitting~     position once placed. Males with both later onset and milder symptoms usually do not require~     ongoing ventilatory support, achieve a higher maximal motor function with ability to sit~     when placed and even walk, and have improved survival rates. Males with XLMTM may experience~     complications (events) at birth and throughout their lifetime. The goal of the study is to~     identify the number of events over twelve months in males with genetically confirmed XLMTM.~     Parents or affected individuals over the age of 18 years who are able to access telephone~     will provide answers to an established event survey to evaluate the frequency and types of~     events. Emergency department, hospital admissions and mortality will be confirmed by~     obtaining medical reports.~      The investigators hypothesize that there will be no association between the frequency of~     events and markers of clinical severity including the need for ventilatory support at birth,~     current level of ventilatory support (no support, support less than 12 hours, support more~     than 12 hours) and current motor function (walking, sitting without support, inability to~     sit without support).~   "
92942|NCT01840644|"~     The purpose of this study is to examine the reliability and validity of the rating of~     perceived exertion scale in children post severe traumatic brain injury during treadmill~     exercise.~   "
92943|NCT01840631|"~     Aim 1 - The primary aim of our study is to assess whether group counseling is a non-inferior~     intervention compared to the usual care of individual counseling in the management of~     childhood obesity. In order to achieve this aim, the investigators will compare the mean~     change in BMI after 6 months of intervention in the two study arms.~      Aim 2 - The secondary aim of our study is to determine if the change in BMI is associated~     with changes in the dietary composition, physical activity and metabolic profile.~   "
92944|NCT01840618|"~     Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal~     imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent~     girls and women capable of having children. Polycystic ovary syndrome is associated with~     missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes.~     Girls with polycystic ovary syndrome may have a breathing problem known as sleep apnea.~     Sleep apnea may cause a person to stop breathing for short periods of time while sleeping.~     People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea~     than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime~     sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The~     purpose of this study is to understand how insulin function is affected in presence of sleep~     apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to~     girls with PCOS without sleep apnea. Insulin is one of the hormones made in your body to~     convert food into energy. In people with increase weight body cannot use insulin properly.~     The investigators also want to see if insulin action is also affected by sleep apnea.~   "
92945|NCT01840605|"~     The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen~     fumarate dry syrup in the change in the severity of pruritus after the treatment period.~   "
92946|NCT01840592|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     the drug sorafenib in combination with the drug doxorubicin might have on the growth and~     spread of liver cancer (HCC).~   "
92947|NCT01840579|"~     This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive~     participant cohorts with advanced solid tumors will receive pembrolizumab to assess the~     safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced~     non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either~     cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel~     or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment~     to assess the safety and tolerability of the combination therapy. In Part E, participants~     untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive pembrolizumab in~     combination with either cisplatin/etoposide or carboplatin/etoposide by non-random~     assignment to assess the safety and tolerability of the combination therapy.~   "
92948|NCT01840566|"~     The purpose of this study is to test the safety of delivering the patients' own immune~     cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell~     transplantation (ASCT).~   "
92949|NCT01840553|"~     The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets~     compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to~     colonoscopy.~   "
92950|NCT01840540|"~     To determine the safety and toxicity of intra-arterial infused autologous adipose derived~     mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.~   "
92951|NCT01840527|"~     This primary purpose of this study is to obtain blood samples from participants with both~     early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to~     better understand an abnormal protein found in many melanoma tumors called the BRAFV600~     mutation.~      There will be two separate cohorts (groups) of participants on this study. You will be~     placed in one of the Groups.~      Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be~     compared to the blood samples given in order to further analyze and to understand the~     BRAFV600E gene mutation.~      Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will~     be collected and analyzed.~      Understanding the BRAFV600E gene mutation in melanoma will help the researchers better~     understand the disease, and help plan treatment options for people with melanoma of all~     stages in the future.~   "
92971|NCT01840267|"~     The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an~     increase of intracranial pressure (ICP). Previous studies have proposed that~     ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs~     of increased ICP. Therefore, this study aims to confirm the increased ICP by~     ultrasonographic measurement of ONSD during laparoscopic surgery in pediatric patients.~   "
92955|NCT01840475|"~     Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and~     reducing the burden of associated symptoms.~      The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no~     significant difference between naïve and pre-treated patients. The patients will be divided~     in sub-groups according to the time interval between occurrence of stroke and start of~     treatment (early, medium and late start of treatment according to the first and third~     quartiles time distribution). It is hypothesized that the early start of treatment group~     will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when~     compared to the late start of treatment group.~   "
92956|NCT01840462|"~     The objective of this study is to investigate the efficacy of Dysport® in the treatment of~     cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated~     patients.~   "
92957|NCT01840449|"~     The aim of the study is to identify predictive factors for the response to Lanreotide~     treatment in Acromegaly as well as in Neuroendocrine Tumours.~   "
92958|NCT01840436|"~     MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.~     Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as~     extracellular matrix, by binding to structural proteins, and 2) in cells communication~     process by protecting growth factors. At the site of a lesion, glycosaminoglycans are~     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By~     replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the~     matrix scaffold and cells communication, a process known as Matrix Therapy.~      The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the~     incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of~     upper aerodigestive tract cancers, when used as a preventive agent.~      The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy~     would protect the healthy oral tissue against cytotoxic effect of chemotherapy and~     radiations.~   "
92959|NCT01840423|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     ODM-104 when given to healthy male volunteers.~   "
92960|NCT01840410|"~     This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult~     and adolescent patients with visual impairment due to choridal neovascularization (CNV).~   "
92961|NCT01840397|"~     The hypothesis of this study is to find evidence if there is an influence of spine surgery~     on the serum levels of two proteins secreted from neuronal cells.~   "
92962|NCT01840384|"~     This study is initiated to investigate the effect of multi micronutrient supplementation for~     12 months on serum haemoglobin level in Indonesian young children.~   "
92963|NCT01840371|"~     The investigators study is the randomized controlled study for analyzing clinical benefit of~     pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde~     cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse~     effect during ERCP as the primary end point between two group. The investigators will also~     access satisfaction score for endoscopist and patients as the secondary end point.~   "
92964|NCT01840358|"~     The purpose of this study is to determine if patients have more hypoglycemic episodes the~     first 3 days following pump start compared to their usual number of hypoglycemias with our~     actual pump initiation protocol.~   "
92965|NCT01840345|"~     This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases~     pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will~     be a useful adjunct to opioid treatment in chronic neuropathic pain.~   "
92966|NCT01840332|"~     The treatment of differentiated thyroid cancer (DCT) includes surgery followed by~     radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation~     to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for~     several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing~     the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved~     during 4-6 weeks in majority of patients.~   "
92967|NCT01840319|"~     The goal of this retrospective observational study is to collect only status survival data~     30 days after the last dose of treatment of patients included in the initial protocol WYETH~     3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the~     last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.~   "
92968|NCT01840306|"~     Primary Objective:~      (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents,~     considering clinical responses. (ii) To investigate associations between presence vs.~     absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients'~     clinicopathological characteristics, including age at diagnosis, time to progression and~     overall survival, as well as correlations with serum protein biomarkers routinely analysed~     for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for~     the existence of RNAs/proteins identified in (i) and (ii).~      Secondary Objective:~      To develop a predictive model for use in the HER2 positive population based on the most~     accurate and sensitive combination of the identified biomarkers.~   "
92969|NCT01840293|"~     Primary objective:~      The primary objective is to define the proteomic and molecular characteristics of primary~     and recurrent/ metastatic breast tumours with special focus on the expression of S100~     protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth~     factor receptor 2 (HER2) genes~      Secondary objective:~        -  To expand our understanding of the complex molecular pathways dictating the progression~          of breast cancer and their response to different treatment regimes.~        -  To relate proteomic findings to survival data~        -  To identify potential serum markers of breast cancer progression~   "
92970|NCT01840280|"~     The main purpose of this observational study with Irinotecan onkovis is to determine the~     number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose~     under the special circumstances of ambulant chemotherapy.~      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This~     includes provision of appropriate packaging sizes to decrease the excess quantity to be~     discarded, and thus also follows this objective.~      Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this~     end, data regarding co-medication and adverse events are also collected.~   "
92974|NCT01840228|"~     Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant~     death and disease. Progesterone is the single most effective intervention in the prevention~     of preterm birth. However, current use of this therapy is limited to certain high-risk~     groups including women with a history of preterm birth and women with a short cervix. This~     study seeks to evaluate the efficacy of this preventive therapy in another high-risk group:~     women with arrested preterm labor. The investigators hypothesize that administration of~     vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours~     after cessation of short-term therapy to inhibit contractions will result in lower rates of~     preterm birth before 37 weeks' than will administration of placebo.~   "
92975|NCT01840215|"~     Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the~     past decades. When deciding for a retrobulbar block, the local injection of varying mixtures~     and volumes of fast-acting anesthetics (such as lidocaine) - with or without a~     vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the~     standard care to provide painless surgery while minimizing the possible risks such as~     increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood~     flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to~     play a role in intra-operatory vision loss (a wipe-out phenomenon) in patients with~     advanced glaucoma.~      The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of~     the anesthetic in general circulation and thus to achieve a longer effect in the orbit.~     However, studies on ocular blood flow after adrenaline-containing compounds have~     consistently showed a decrease in ocular blood flow, thus raising the issue of whether it~     should be used in patients with known vascular dysfunction, namely glaucoma patients.~     Nevertheless, there has been no study to verify this claim concerning the safety of~     non-adrenaline containing anesthetics.~      Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its~     formulation has also been debated. The orbital pressure increase can lead to a number of~     adverse reactions, not only increasing IOP but also potentially decreasing vascular input by~     local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to~     be less elastic than in healthy individuals, potentially making this structure less~     compliant to outside compression. These more rigid orbital tissues could also impair the~     orbit's ability to deal with the iatrogenic increased volume.~      As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the~     vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim~     to study this impact through a non-invasive, widely established ultrasound based method of~     ocular blood flow research (color Doppler Imaging). Potentially, our study could help~     determine a taylor-made choice of the anesthesiology procedure to apply to a specific~     patient, thereby advancing the current standard of care in ophthalmology.~   "
92976|NCT01840202|"~     Glaucoma is a leading cause of blindness worldwide, whose treatment - intraocular pressure~     lowering - is only partially effective in preventing disease progression. Accordingly, other~     variables, such as ocular blood flow-related factors, have been implicated in disease~     pathogenesis. However, most findings involving vascular variables come from partial,~     small-scale studies. Furthermore, recent technological advances have identified a number of~     ocular blood flow variables that have yet to be tested in large scale trials. Therefore, a~     study that specifically aims at uncovering the role of vascular aspects in glaucoma is~     needed.~      For this purpose, a cross-sectional, observational case-control study will be conducted in~     the University Hospitals Leuven. This will be the largest-yet study on the subject,~     involving more than 750 patients. This will allow the creation of a specific cohort of~     patients where the vascular aspects are thought to be particularly important (low-tension~     glaucoma). It will use the largest combination yet of vascular-related measuring techniques~     (dynamic contour tonometry, optic coherent tomography, colour Doppler imaging and retinal~     oximetry)~   "
92977|NCT01840189|"~     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency~     (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms~     and long-term complications.~      The majority of Addison's patients have other organ-specific autoimmune disease, which poses~     challenges to the replacement therapy. Of particular interest is the combination of~     Addison`s disease and type 1 diabetes, since cortisol affects glucose homeostasis. The~     clinical experience is that this subgroup of patients is difficult to treat, but very little~     research has been done to understand and improve their situation.~      Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone~     infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further~     evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic~     effects especially glycemic control in patients with the combination of Addison`s disease~     and type 1 diabetes in an 5 months cross-over design open clinical pilot study.~   "
92978|NCT01840176|"~     The purpose of this study is to assess the feasibility of performing prophylactic McCall~     culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be~     measuring pelvic support (using POP-Q) and sexual function before and at different time~     points (up to 12 months) postoperatively.~      The investigators hypothesize that women undergoing the McCall culdoplasty will not have~     different immediate surgical outcomes (operative time, etc) and may have better pelvic~     support and sexual function in the future.~   "
92979|NCT01840163|"~     This study examines the impact of an online decision tool for patients with early stage~     invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly~     diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.~     Participants will be randomized to receive either a basic version of a decision tool~     (similar to existing website with breast cancer information) or an enhanced version~     (featuring a knowledge building component, a values clarification exercise, and a patient~     activation module). Our hypothesis is that patients who use the enhanced version of the tool~     will have greater knowledge of their test and treatment options, have a higher rate of high~     quality (i.e., informed, preference-concordant) decisions, and report more positive~     appraisal of the decision-making process.~   "
92980|NCT01840150|"~     This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and~     detecting recurrence after surgery or radiation therapy in patients with stage I or stage II~     non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to~     monitor response and detect recurrence of NSCLC after surgery or radiation therapy.~   "
93026|NCT01839552|"~     Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is~     used to manage breakthrough pain in adults with cancer who are already routinely taking~     other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after~     taking other opioid pain medicines and the patient's body has become used to them (opioid~     tolerant).~      The purpose of this study is to assess the ability of Lazanda to control pain during an~     episode of breakthrough pain in cancer patients.~   "
93027|NCT01839539|"~     The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced~     killer cells (DC-CIK) for colorectal cancer (CRC).~   "
92981|NCT01840137|"~     The development of clinically relevant and scalable exercise interventions in older~     cystectomy patients may have an impact upon:~        -  Patients: Exercise interventions may improve patient outcomes, including quality of~          life and avoidance of skilled nursing facilities.~        -  Clinicians: Proving the safety and feasibility of targeted interventions in older~          surgical patients may facilitate the development of clinically relevant preoperative~          interventions suitable for wider study and implementation.~        -  Payers: Improved surgical outcomes among high risk surgical patients will be associated~          with significant cost savings.~        -  Researchers: Targeted and well controlled studies focusing on improving surgical~          outcomes through exercise may provide insight into relationships between patient~          factors, surgical stressors and outcomes. Ultimately, such work may lead to novel~          clinical approaches to optimize patients for surgery.~      The investigators will study the effects of preoperative exercise training on cystectomy~     patients, specifically targeting increasing functional capacity and muscular strength. Prior~     to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility,~     safety, and initial efficacy of preoperative exercise in cystectomy patients must be~     determined. To address this issue, the investigators will complete a trial of rehabilitation~     in cystectomy patients at the University of Michigan.~   "
92982|NCT01840124|"~     The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine~     fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA~     approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy~     to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved.~     The radiofrequency energy is delivered to the fibroids during an outpatient surgical~     procedure. There is minimal blood loss and pain and women return to the usual activities 5-9~     days after the Acessa procedure.~      The investigators will evaluate changes in fibroid-related symptoms from before the Acessa~     treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators~     will also assess operative outcomes including procedure duration, complications, blood loss,~     post-operative pain, and the time to return to usual activities. The investigators will~     determine long-term efficacy of Acessa by evaluating the rate of re-treatment for~     symptomatic fibroids after the Acessa procedure.~      Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC~     Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as~     the Coordinating Center for the trial with oversight of all scientific and administrative~     aspects of the study. All study data will be stored securely in a HIPAA compliant, secure~     database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring~     board will oversee participant safety and protection.~   "
92983|NCT01840111|"~     The overarching goals of this proposal are to 1) identify the network of brain regions~     specifically activated by personal smoking environment cues and 2) to evaluate the effects~     of exposure to these cues on smoke self-administration and subjective reactivity. The~     results of this study will inform the development of novel and more efficacious~     cue-exposures therapies targeted at helping smokers quit smoking and will provide novel~     mechanism information regarding the influence of environmental context on drug taking.~      The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is~     prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in~     part because they have not included cues representative of the contexts in which drug use~     occurs. By demonstrating that context cues have a differential and robust influence on brain~     and behavioral responses, we will have provided a substantial basis for including such~     stimuli in the context of treatment. At the same time, we will have identified novel~     mechanisms by which such stimuli promote continued drug use and relapse.~   "
92984|NCT01840098|"~     The purpose of this study is to investigate metabolic effects of 3 different nutritional~     compounds.~      Fasting (36 hours) creates a catabolic state that is comparable with the catabolic state~     seen in acute illness.~      This study is a randomized, placebo cross-over study investigating 8 healthy men on 4~     separated days (at least 3 weeks between trials).~        -  High leucine content drink~        -  Low leucine content drink~        -  Low leucine content drink + HMB~        -  Carbohydrate (isocaloric)~      The investigators hypothesize that these nutritional supplements may counteract catabolic~     processes in different ways and degrees.~   "
92985|NCT01840085|"~     To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous~     treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple~     ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.~   "
92986|NCT01840072|"~     This randomized trial tests the effect of early blood pressure reduction on major disability~     and death among patients with acute ischemic stroke in china.~   "
92987|NCT01840059|"~     The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a~     treatment that lowers the activity of the sympathetic nervous system) is useful in the~     management of patients with heart failure with preserved ejection fraction (HF-PEF).~   "
92988|NCT01840046|"~     Alopecia areata is an autoimmune disease associated with infiltration of cluster of~     differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair~     follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia~     areata is the induction of tolerance. This tolerance induction can be obtained by~     stimulating regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in~     the development, expansion, regulation and survival of regulatory T cells CD4 + cluster of~     differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant~     interleukin 2 (IL2-R) with low dose showed very promising results in two inflammatory~     disease (GVHD vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy,~     increased population Treg in the blood and an excellent safety profile. We hypothesized that~     administration of IL2-R in patients with severe alopecia areata might allow regrowth via~     activation of Treg and thus induce regrowth of the air.~   "
93041|NCT01839357|"~     A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with~     left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to~     rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo~     image and common clinical outcomes such as bleeding and stroke or thromboembolism.~   "
92989|NCT01840033|"~     Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal~     chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate~     and be able to preserve the permeability of the central vein. Today, in europeen guidelines,~     two types of central devices are recommended: tunnelled central catheter with cuff and~     implanted ports. However, their insertion is not without risk. Since many years, we have~     seen a new generation of catheter - peripherally inserted central catheter (PICC line)-~     which have many advantage over other central catheter. ESPEN guidelines accept the use of~     PICC line in short and moderate-term for HPN, but no prospective study have look for~     long-term used in HPN.~      The objective of our study is to evaluate in a prospective randomised monocenter study the~     no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter~     related-complications such as infection and thrombophlebitis for patient on HPN over 1 month~     of duration. The secondary objectives are to: evaluate the number of patients with at least~     one serious complications related in 1000 days of used, the rate of minors and majors~     complications, number of catheter inserted, the satisfaction of patients and doctors.~      The study is held in CHU Nice and will be proposed to hospitalized patients who will need~     HPN. After consent, patients will be randomized to receive PICC Line (group A) of~     nutritional central catheter with cuff (group B). Echography of vessels will be held at the~     beginning, 3 months and 12 months. Follow-up will be conduct at regular interval (month~     0-1-3-6-9-12). The duration of follow-up will be of 12 months and the global duration of the~     study will be 36 months. One major complication will conduct to withdrawal of the study.~     There will be 55 patients in each group.~   "
92990|NCT01840020|"~     The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size~     and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass~     procedure, involves significant changes to the size and function of the stomach and leads to~     more rapid gastric emptying. Consequences will be faster absorption and higher peak~     concentration of ethanol after surgery than before. There are growing concerns that surgery~     for obesity in this way may cause alcohol abuse.~      In this study the investigators compare changes in FPM of ethanol following two different~     bariatric surgical procedures.~   "
92991|NCT01840007|"~     In western countries, melanoma represents a major mistake of public health by its frequency,~     lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early.~     In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of~     visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6~     months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response~     rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a~     response rate of 10%, and other available treatments don't have a superior efficiency.~     Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation~     of AMPK, a molecule which is inactivated in many cancers including the melanoma. In~     agreement with these data, several preclinical studies suggested that metformin has~     antineoplastic activity. In the case of melanoma, a study published recently has showed that~     metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part~     these results in our laboratory (INSERM U895).~   "
92992|NCT01839994|"~     The purpose of this study is to compare the outcomes of conventionally fractionated~     conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or~     stereotactic body radiotherapy for intermediate or high-risk prostate cancer patients.~   "
92993|NCT01839981|"~     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with~     locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as~     6,8-bis(benzylthio)octanoic acid, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
92994|NCT01839968|"~     The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to~     reverse the antiplatelet effects of prasugrel.~   "
92995|NCT01839955|"~     This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when~     given together with erlotinib hydrochloride and to see how well it works in treating~     patients with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells~   "
92996|NCT01839942|"~     For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well~     established. Mainly three techniques are currently applied:~        -  no closure at all~        -  extracorporal suturing of the gap~        -  intracorporal suturing of the gap~      All three techniques have been applied at our hospital. Patients who received laparoscopic~     hernia repair between 2006 and 2011 will be identified from the patient database and will be~     contacted by phone to inquire about the outcome and the satisfaction of the surgery.~   "
92997|NCT01839929|"~     The purpose of this study is to evaluate the efficacy of tacrolimus modified release~     formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.~   "
92998|NCT01839916|"~     This pilot phase II trial studies how well giving donor T cells after donor stem cell~     transplant works in treating patients with hematologic malignancies. In a donor stem cell~     transplant, the donated stem cells may replace the patient's immune cells and help destroy~     any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T~     cells (donor lymphocyte infusion) after the transplant may help increase this effect.~   "
92999|NCT01839903|"~     Emergency Departments (EDs) are a critical component of the U.S. healthcare system, treating~     over 119 million patients each year. While EDs have historically neglected tobacco control~     efforts, several recent studies have examined the feasibility and efficacy of implementing~     tobacco cessation in the ED. Work by our research team and others, has shown that tobacco~     treatment is both feasible and effective in the ED setting.~      Effective, evidence-based interventions for treating tobacco dependence have also been~     codified in the United States Public Health Service guidelines. Even brief interventions~     delivered by physicians and other healthcare providers can produce significant increases in~     cessation across diverse clinical settings (e.g., outpatient clinics, surgery units, EDs),~     and patient groups (cardiac, respiratory, general admissions). However, in clinical~     practice, delivery of tobacco interventions is inconsistent at best, particularly in~     non-primary care settings.~      This translational study uses an existing Emergency Department Information System (EDIS), to~     facilitate the identification of smokers and to enhance the provision of smoking cessation~     intervention materials and pharmacological adjuncts for patients receiving treatment in the~     ED. The EDIS tracks the geographic and chronologic progression of patients through the ED~     and contains triage and nursing notes, lab values, radiology reports and links to images,~     vital signs, embedded printable discharge instructions, and fax links to primary care~     provider (PCP) offices.~      Following recruitment of a baseline (care-as-usual) cohort (Step 1), the investigators will~     provide training to ED physicians and staff to improve the identification and treatment of~     smokers. Following Step 1, the investigators will make adaptations to the EDIS system that~     include smoking status tracking, tobacco treatment prompts and medication information panels~     for the emergency treating physician, and links to printable discharge instructions,~     quit-smoking medication information and referral to a pro-active phone follow-up counseling~     for enrolled smokers. A second cohort of participants (Step 2) will be enrolled after~     implementation is complete. Contemporaneous with Steps 1 and 2, participant cohorts will be~     recruited at a control site (UMass Medical) to control for potential effects of historical~     trends. This study represents a comprehensive systems-based translation of empirically~     supported tobacco treatment built into a widely used patient tracking platform (MedHost)~     maximizing the probability of developing a sustainable tobacco intervention that can be~     readily disseminated.~      Specific Aims A.1. To test the incremental efficacy of a modified Emergency Department~     Information System (EDIS) MedHost, using a multiple-cohort design implemented in 2 steps.~     Two recruitment phases (baseline/care as usual and full implementation) will be used to~     assess the impact of EDIS enhancements on rates of identification and treatment of ED~     patients who smoke. The primary outcome is the difference in six-month abstinence between~     those recruited prior to program implementation (Baseline) versus those recruited when the~     program is fully implemented (Step 2). H1) Smokers enrolled during Step 2 at RIH will show~     significantly greater cessation at month 6 compared Step 1 and control site participants.~      A.2. To compare rates of smoker identification, physician intervention and follow up care~     for smoking cessation and use of quit-smoking medications among ED patients recruited before~     and after EDIS modification. H2) Compared to Step 1 and the control site, Step 2 will show~     significantly higher rates of smoker identification, physician intervention and follow-up~     for smoking, and use of quit-smoking medications.~      A.3. To investigate the effects of the EDIS enhancement on relevant behavioral and~     psychological constructs that may act as mediators of smoking behavior change (Mechanisms~     of Action), and the relationships of these potential mediators to smoking cessation (e.g.,~     perceived risk, nicotine dependence; in Measures section). H3) Participants enrolled during~     Step 2 at RIH will show greater changes in posited mediational constructs than those~     enrolled in Step 1 and at the control site.~      A.4. To examine the incremental costs of implementation of the intervention and to conduct~     analyses of marginal cost effectiveness using cost-per-smoker-quit. (This aim is not~     hypothesis driven) Exploratory Aim: A.5. To examine ED physician and other health care~     providers (HCP) attitudes regarding the utility of the EDIS system for tobacco intervention.~     The investigators will conduct interviews with ED physicians and nurses to elicit their~     perceptions of the usefulness and helpfulness of the modified EDIS, and its effects on their~     perceived self-efficacy and motivation to provide tobacco intervention. The investigators~     will also solicit direct feedback on the modified platform and user interface.~   "
93000|NCT01839890|"~     Study objective is the evaluation of safety and efficacy at 9 months of combination~     treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent~     (conventional treatment) in patients with acute myocardial infarction with systolic time~     elevation of less than 12 hours of evolution.~   "
93112|NCT01838421|"~     In the context of the study a retrospective data collection of all anaesthesia protocols of~     children under the age of 12 which underwent surgery in the Charité - University Medicine~     Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The~     correlation of the tracheal tube sizes with the weight, age and height shall be evaluated.~     This data collection should serve to reevaluate the already published formulas e.g.~     (Rettberg M. et al., 2011).~   "
93001|NCT01839877|"~     Treatment of patients with colorectal cancer having liver metastases is currently based on~     systemic chemotherapy.~      Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of~     response and secondary resectability, however it is particularly toxic.~      Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has~     shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up~     and reserved for experienced centers.~      The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin~     associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto~     microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to~     2 sessions, and therefore could be more easily generalized.~   "
93002|NCT01839864|"~     The study aims are to test whether the use of promotoras significantly impacts the health~     attitudes, health seeking behaviors, and patient confidence in self-managing health of rural~     Hispanic adults who have been diagnosed with metabolic syndrome. Specifically, the study is~     designed to address four areas of inquiry: 1) identification of patient attitudes involving:~     a) trust in medical providers and in the health care system, b) procedural fairness in~     treatment, c) provider and patient communication patterns, d) potential cultural bias in~     treatment, and e) healthy lifestyle behavior adoption/maintenance, 2) selected clinical~     indicators of metabolic syndrome (blood pressure, height/weight/BMI, blood glucose,~     hemoglobin A1c, and cholesterol), 3) the cultural competence of medical providers from the~     perspective of both the provider and the patient, and 4) patient self-management confidence~     scores.~   "
93003|NCT01839851|"~     The purpose of this study is to prospectively examine the relation between topical~     corticosteroid use and hair cortisol concentration, among patients with moderate persistent~     asthma or allergic rhinitis. The investigators hypothesize that patients with asthma or~     allergic rhinitis treated with topical corticosteroids (i.e. inhaled corticosteroids (ICS)~     or intranasal glucocorticoids (INGC)) have higher levels of hair cortisol after 3 months of~     treatment than during the 3 months prior to initiation of treatment.~   "
93004|NCT01839838|"~     The overall objectives of the study are to establish feasibility and acute side effects of~     accelerated partial breast irradiation therapy, along with more long-term side effects and~     clinical efficacy of treatment.~   "
93005|NCT01839825|"~     The objective of the study is to examine the efficacy and safety of QuietCare in a~     randomized, open study in elderly subjects living in assisted/ independent living facilities~     for 6 months.~   "
93006|NCT01839812|"~     Our objective was to determine whether a standard 1mg/kg intraoperative dose of~     dexamethasone results in similar drug levels for all patients and to characterize the~     relationship between these drug levels and the innate stress response following infant~     Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative~     dexamethasone levels are highly variable, and that the infant stress response is inversely~     related to the amount of dexamethasone measured in the blood. To test this theory the~     investigators simultaneously measured blood levels of dexamethasone and cortisol at critical~     time points during the perioperative period for infants undergoing CPB for CHD surgery.~   "
93007|NCT01839799|"~     Determine the relapse-free survival of resected pancreatic cancer patients following two~     novel regimens with activity in advanced disease.~   "
93008|NCT01839786|"~     The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary~     hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart~     catheterization (RHC) in order to assess whether this non-invasive tool could be used in~     pulmonary hypertension diagnosis and monitoring.~   "
93009|NCT01839773|"~     The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral~     paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent~     Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.~   "
93010|NCT01839760|"~     The objective of the study is virological assessment (e.g., proportion of prolonged viral~     shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult~     influenza patients admitted to the general ward and/or to the ICU and to assess the~     correlation with the clinical manifestations and prognosis.~   "
93011|NCT01839747|"~     This research study is a Pilot study (a small preliminary study to assess the feasibility of~     a larger, more in depth study involving a new test or procedure) and is being done to~     evaluate the feasibility and accuracy of PET/MRI in the evaluation of cancer. PET/MRI is a~     FDA approved technology that is currently being studied to assess its accuracy and utility~     in the diagnosis and management of a variety of diseases and patient populations. The focus~     of this particular study will be to compare the performance of PET/MRI in its ability to~     detect and characterize cancerous tumors using positron emission topography and computed~     tomography (PET/CT) as a reference standard.~   "
93012|NCT01839734|"~     The use of lubiprostone will decrease the levels of immune activation in HIV-infected~     subjects with incomplete CD4+ T-cell recovery with antiretroviral therapy (ART).~        -  Lubiprostone will decrease levels of translocated gut microbial products in~          HIV-infected subjects with incomplete CD4+ T-cell recovery with ART.~        -  The decrease in levels of translocated gut microbial products will be associated with a~          decline in the levels of immune activation in HIV-infected subjects with incomplete~          CD4+ T-cell recovery with ART.~   "
93013|NCT01839721|"~     In this double-blinded randomized clinical trial study, investigators assessed probiotic~     used to prevent or delay radiation induced grade moderate to severe diarrhea with patient~     treated for pelvic cancer.~   "
93014|NCT01839708|"~     Mothers in Motion will draw on the successes of the pilot intervention of the same name and~     will promote healthy lifestyle behavior changes (eating more fruits and vegetables,~     increasing physical activity, dealing with stress) in low-income WIC mothers of young~     children. The intervention group's weight change (difference between the initial enrollment~     and 3 months post intervention) will differ from the control group's weight change by an~     average of at least 2.8 pounds.~   "
93015|NCT01839695|"~     The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms~     of the descending thoracic aorta (DTA) in patients who require coverage of the left~     subclavian artery (LSA).The study is intended to assess safety and performance of the device~     acutely and at 30 days.~   "
93017|NCT01839669|"~     Pes planovalgus, also called flat foot, is a common foot deformity characterized by a~     flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the~     posterior tibial tendon (posterior tibial tendon dysfunction or PTTD). Early stages of~     this pathology are thought to be treated with non-surgical therapy options like foot~     orthoses (relief of tendon stress by mechanical unloading of the arch), strengthening~     exercises or basic physiotherapeutic measures. Recent literature clearly states the urgent~     need for high quality studies to evaluate the proposed non-surgical treatments (Bowring~     2009, 2010). There is only one high quality study available that shows benefits of orthoses~     therapy and exercise (Kulig 2009). No study to date evaluated functional changes pre-post in~     dynamic movement pattern like gait or stair climbing. The widespread use of several~     non-surgical treatment strategies lead to extensive financial expenses of the health care~     system. An optimized therapeutic strategy could eventually lead to more efficient health~     care investments. The presented proposal addresses this latest knowledge and aims to analyse~     non-surgical treatment strategies to Cure Pes Planovalgus associated Complaints (CurePPaC)~     in the CurePPaC Study.~   "
93018|NCT01839656|"~     This study will test the efficacy, safety, tolerability, and pharmacokinetics of multiple~     doses of IONIS-SMNRx administered into the spinal fluid three times over the duration of the~     trial, in patients with Infantile-Onset Spinal Muscular Atrophy.~   "
93019|NCT01839643|"~     In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a~     local route (vaginal) and observe the effect on follicular development. This study will~     include 3 menstrual cycles, beginning with one menstrual control cycle, following by one~     menstrual cycle with meloxicam ring administration and finishing with another control~     menstrual cycle.~      Meloxicam will be administered via a vaginal ring in two doses of 2.4 g and 3.0 g/ ring~     during one menstrual cycle. Safety study of absorption will be assessed. Also the~     investigators will study the effect on follicular development and if it maintains ovarian~     cyclicity, as well as shown in recent study with oral administration.~   "
93020|NCT01839630|"~     This study is to obtain the characteristics and treatment pattern of the unresectable HCC~     patients who are candidates for systemic therapy and in whom a decision to treat with~     sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd~     TACE procedure) has been made under real-life practice conditions.this study will also~     conclude the safety and effectiveness of combination in uHCC patients.~   "
93021|NCT01839617|"~     The aim of this study is to find which is the best nutritional strategy in cancer patients~     undergoing abdominal surgery regarding postoperative complications.~   "
93022|NCT01839604|"~     This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with~     advanced/metastatic hepatocellular carcinoma.~   "
93023|NCT01839591|"~     In severe bronchial asthma the mechanism of inflammation and bronchospasm is complex and~     still not clarified. The smooth muscle cells play an important role from the mechanical~     point of view, as a culmination of neurogenic stimuli and inflammatory cytokines that~     determine as final effect the bronchospasm and over time a hypertrophy of the muscular coat.~     There are some other hypothesis that the smooth muscle cells may play a role as central~     regulator of chemical mediators that cause bronchospasm and inflammation, although there are~     currently no firm conclusions 2 According to other studies3,the nerve receptors TRANSIENT~     RECEPTOR POTENTIAL VANILLOID TYPE 1 have a great importance in the complex mechanism of~     airway inflammation too. (There are at least 4)~      These receptors would intervene according to the following mechanism:~        1. Irritants on the bronchial mucosa stimulate the TRANSIENT RECEPTOR POTENTIAL VANILLOID~          TYPE 1 present on afferent endings of sensory fibers, unmyelinated C (chemiosensitive~          neurons)~        2. On the same afferent axon acting factors with the activation effect (lowering the~          activation threshold, increase the expression, promote the translocation of TRPV1~          receptor on the membrane). Among these factors the neurotrophins of which the most~          important NERVE GROWTH FACTOR (NGF)~        3. The activation of TRPV1 (through release of Ca2 + +) determines two efferent responses:~             1. CENTRALLY-MEDIATED~             2. LOCAL AXON Reflex~      Investigators hypothesized that BT may have a strong influence on the destruction of nerve~     receptors TRPV1 and unmyelinated nerve fibers located in the mucosa going to stop~     reflections both central and local authorities responsible for the activation of~     bronchospasm. In support of this hypothesis, there are some anatomical studies4, which show~     that these receptors are more numerous at the level of main bronchi which are the main~     target of BT. Please note in this context that it is already known that in thermoablations~     commonly used in cardiology it is used a radio frequency with development of heat controlled~     to 65 °, as in the BT, able to interrupt the circuit nervous responsible for the activation~     of the circuit causing the abnormal 'arrhythmia.~   "
93024|NCT01839578|"~     Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units~     (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of~     continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for~     septic shock due to their ability to remove middle molecular weight molecules such as~     inflammatory mediators involved in MODS pathophysiology. These therapies are called~     extracorporeal  blood purification  therapies.~      When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal~     circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies~     have been proposed and the most commonly used in 2013 is still unfractionated heparin.~     Regional citrate anticoagulation (RCA) is an interesting alternative as it dramatically~     decreases the bleeding risk.~      The investigators hypothesize that the use of citrate with Super High Flux Continuous~     Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the~     filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore~     sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the~     inflammatory mediators could be maintained over time with citrate as compared to heparin~     anticoagulation. In other words, for the same duration of filter use, middle molecular~     weight molecules and cytokines clearances would be greater with citrate as compared to~     heparin. To test this hypothesis, the investigators will perform a clinical randomized~     controlled trial which aim would be to compare middle molecular weight molecules and~     cytokines clearances in SHF-CVVHD using RCA versus systemic heparin anticoagulation in~     septic patients with AKI.~   "
93025|NCT01839565|"~     The absence of methodologically, prospectively and retrospectively collected information on~     the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a~     multicenter approach. Using a registry to get more information about the effectiveness and~     possible benefits or complications during the surgery and during the post-operative~     treatment is adequate and necessary to get new insights to the use of the Quadrilateral~     Surface Plate.~   "
93180|NCT01837537|"~     The purpose of this study is to meet the respiration rate accuracy specifications for the~     study pulse oximeter monitoring system (study device) in a hospitalized volunteer population~     when compared to established technologies for measuring parameters related to respiration,~     such as Capnograph Respiration Rate (RR)(CO2).~   "
93028|NCT01839526|"~     No investigational drug will be administered in this study for the treatment of Fabry~     disease.~      This will be a multicenter, multinational, non-treatment, cross-sectional study of young~     male patients with Fabry disease who have not yet initiated interventional treatment for~     this disease. The study will consist of a screening visit(s), a clinical investigation~     visit(s), and a follow-up phone contact.~      The objectives of the study are:~        -  To document renal function and other Fabry disease manifestations across age in~          treatment-naïve, young male patients with Fabry disease.~        -  To provide a reference group for comparison with interventional clinical trials of~          Fabry disease.~      The duration of each patient's participation in the study, inclusive of the screening visit~     and follow-up phone contact, will be approximately 12 weeks.~   "
93029|NCT01839513|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the~     prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower~     limb orthopedic surgery on desflurane/remifentanil general anesthesia.~   "
93030|NCT01839500|"~     This prospective, multi-center, non-interventional study will evaluate the efficacy and~     safety of Herceptin (trastuzumab) in routine clinical practice in Chinese patients with~     gastric or gastro-oesophageal cancer. Treatment patterns and clinical outcomes in patients~     with gastric cancer in China will be evaluated. Data will be collected from eligible~     patients for up to 6 years.~   "
93031|NCT01839487|"~     To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine~     (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer.~      The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization,~     PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a~     second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).~   "
93032|NCT01839474|"~     The purpose of this study is to determine if the use of a continuous positive airway~     pressure (CPAP) machine (a device that blows air into the lungs) decreases the chance of a~     child dying from difficulty breathing.~   "
93033|NCT01839461|"~     The purpose of this research study is to identify factors and genes (the DNA material that~     determines the makeup of the human body) that may be associated with how children respond to~     pain medication. Morphine is a pain medication commonly prescribed after this surgery during~     the hospital stay. The investigators want to study factors that may be associated with pain~     sensitivity, morphine requirement after surgery and side-effects from morphine. The~     investigators expect that the information obtained in this research study will help to~     develop effective, safer, and tailored treatment options in the future.~   "
93034|NCT01839448|"~     The main objective of the study is to estimate and compare the percentage of patients with~     abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed~     with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism~     is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.~   "
93035|NCT01839435|"~     The aim of our monocentric prospective in intention-to-treat study is to evaluate the~     feasibility of outpatient appendectomy for non complicated acute appendicitis.~   "
93036|NCT01839422|"~     This research attempts to better understand the altered and preserved memory mechanisms in~     Alzheimer disease, particularly to better apprehend learning implicit memory processes, and~     give a scientific support to non-pharmalogical interventions. At the present time, it is~     possible to delay the emergence of the symptoms related to this disease, eventually to~     decrease it, but not to cure it. Yet, care these patients became a crucial question and the~     solutions proposed to healthy aging people are not appropriate for Alzheimer patients who~     present specific disorders. The improvement of the quality of life of the institutionalized~     patients lies on a better comprehension of their disorders but also of their preserved~     abilities. The literature testifies of a great heterogeneity in the clinical expression of~     this disease, however we noticed two constants with regard to the capabilities generally~     announced as being preserved, on one hand, the implicit memory, and on the other hand the~     artistic aptitudes, and more particularly musical capabilities.~      Patients with Alzheimer disease present a particularly severe and early deterioration of~     episodic memory. Thus, at the beginning of the disease the explicit acquisition of new~     knowledge becomes increasingly difficult. However, some clinical observations, such as new~     learning of unknown songs, even with patients at a severe stage of the illness, seem to~     support the assumption of a preservation of some implicit learning abilities. Indeed,~     several studies already showed preserved implicit memory capabilities among patients with~     Alzheimer disease, mostly at the beginning stage of the illness: preserved effects of~     perceptual priming, procedural learning. Thus, we are mainly interested by the effects of~     exposure and the rising of a feeling of familiarity, both showing preserved implicit~     learning abilities, for moderate to severe Alzheimer patients. However, no study was carried~     out to date using the neuroimaging techniques, among Alzheimer patients at a moderated to~     severe stage of illness, with the main objective to identify the cerebral substrates implied~     in the learning of new knowledge.~      Indeed, several studies already showed preserved implicit memory capabilities among patients~     with Alzheimer disease, mostly were performed at the beginning stage of the illness and none~     of them have studied theses learning abilities for moderate to severe Alzheimer patients.~      The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive~     mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to~     highlight neural networks underlying this learning process (recently learned stimuli vs old~     stimuli). The goal is to propose a positive image of the Alzheimer patients, in~     understanding which cognitive mechanisms and cerebral areas allow these learning~     capabilities.~      20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage~     of the illness, and 20 healthy aging participants, are selected after a neurological~     interview and a neuropsychological evaluation. The whole of the included participants take~     part of the experimental protocol organized in two phases: - the phase of familiarization~     and the phase of test. The phase of familiarization consists of the repeated exposure (daily~     session before the MRI acquisition) of new songs and new painting until obtaining a high~     feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera,~     it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional~     acquisition corresponds to a passive listening and seeing tasks of musical and pictorial~     stimuli. Finally, all participants realize a debriefing phase that allows obtaining a~     feedback on the familiarity of stimuli presented during the functional acquisition.~   "
93037|NCT01839409|"~     The purpose of this study is to study the relationship between the vestibular system and~     chronobiology~   "
93038|NCT01839396|"~     The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's~     Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,~     levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled~     with medication.~   "
93039|NCT01839383|"~     The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12~     months, iPTH 150-300pg/ml and serum calcium<2.5mmol/L. Patients were randomized to three~     groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25),~     1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was~     performed for 4 hours three times weekly. Serum total calcium(tCa), ionized~     calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before~     and after the study and single dialysis session in every patient. iCa and P levels were~     measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP),~     osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP）and~     vascular calcification were measured in every patient periodically. vascular calcification~     including aortic arch calcification, abdominal aorta calcification and coronary artery~     calcification were measured by chest radiography, lateral lumbar radiographs and coronary~     artery computer tomography (CT) respectively. The primary endpoints included death,~     cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and~     stroke), newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine~     and valvular or vascular calcification. The secondary endpoint were admission or emergency~     observation.~   "
93040|NCT01839370|"~     In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing~     continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide~     therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well~     recognized to help control hyperglycemia with meals, will be evaluated in both closed loop~     and open loop control. It is expected that the closed loop control condition with~     pramlintide will improve glycemia, thus combining better control with enhanced safety. In a~     recent pilot study, the investigators started testing this concept and collected data~     showing that in order to be successful such strategy must have a controller equipped with~     the ability to optimize the configuration and timing of meal boluses with concomitant~     administration of pramlintide. Our preliminary data and review of previously unavailable~     individual data from a German study indicate a large individual variability in the timing of~     the appearance of meal insulin needs. Thus, for both adequate safety and efficacy of meal~     insulin on pramlintide, the investigators have developed a new closed-loop controller that~     accounts for the variability in the individual responses to a meal and meal delays, the~     Adaptive Insulin Meal Supervisor system (AIMS). In this study, the performance of a~     combination between the AIMS system and a standard pramlintide treatment will be tested~     versus the standard pramlintide treatment alone.~   "
93913|NCT01827878|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, human subjects.~   "
93042|NCT01839344|"~     The purpose of this study is to measure the effect of quercetin on glucose tolerance and~     postprandial endothelial function in comparison to placebo and Acarbose in participants with~     Type 2 Diabetes.~      Primary Hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a~     100g maltose tolerance test (MTT) will result in a decrease in postprandial blood glucose at~     60 minutes compared to placebo. Acarbose (100mg oral), a pharmaceutical alpha-glucosidase~     inhibitor, will serve as a positive control.~      Secondary Hypothesis: We hypothesize that administration of quercetin (2g oral) will reduce~     the Area Under the Glucose Curve (AUC) for the 2 hours following a 100g MTT compared to~     placebo. AUC is hypothesized to be comparable between quercetin and Acarbose.~      Tertiary hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a~     100g MTT will result in a smaller reduction in flow mediated dilation (FMD) measured as an~     increase in Reactive Hyperemia Index (RHI) at 90 minutes compared to placebo.~   "
93043|NCT01839331|"~     This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™~     in Adults with pain due to osteoarthritis of the knee.~   "
93044|NCT01839318|"~     The purpose of this study was to compare three CE-marked daily disposable contact lenses for~     tear film stability as measured by pre-lens non-invasive keratograph break up time (PL~     NIK-BUT). Secondarily, contact lens surface wettability was assessed.~   "
93045|NCT01839305|"~     Fibromyalgia Syndrome (FS) is one condition that most affects functional performance,~     especially in women, due to alterations in the entire musculoskeletal system. Given that,~     Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because~     of its complex chronic characteristic, impairs the affected individual's activities causing~     movement disorders, a PT professional must be part of the multidisciplinary team involved in~     the FS treatment. Nonetheless, as explained in the present proposal, several aspects still~     need clarification related to the PT role in this syndrome. Particularly, studies that~     analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who~     undergo PT intervention still lack; those studies would contribute with scientific evidence~     to the clinical practice. According to recent systematic reviews, one of the most used~     therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises~     and the water relaxing effects. Other alternative treatments have also been searched, in an~     attempt to decrease the painful picture presented, as the FS etiology and pathophysiology~     are not well known. The aim of this study is to evaluate the efficacy of different physical~     therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is~     effective in modifying movement variables (scapular kinematics and electromyography) and~     autonomic modulation. Other variables, such as pain level and quality of life in women with~     FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu~     massage on pain, sleep quality, balance and quality of life of subjects with FS.~   "
93046|NCT01839292|"~     Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a~     common complication of uncovered SEMSs. However, they have revealed a high incidence of~     stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A~     conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth.~     The aims of this study were to evaluate the clinical outcomes of newly designed conformable~     covered and uncovered SEMS for palliation of malignant GOO.~   "
93047|NCT01839279|"~     This is a single-center, partial-blind, randomized, placebo-controlled, parallel design~     study with a nested crossover comparison to define the ECG effects of tizanidine compared to~     placebo and the positive control, moxifloxacin, in healthy men and women. The study will be~     conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the~     protocol.~   "
93048|NCT01839266|"~     Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be~     rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and~     therapeutic modalities, it is still one of the important causes of hospital mortality.~     Previous several reports have described the variable outcome of patients with PE with~     reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock)~     and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies~     from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV~     unfractionated heparin. We conducted this study to determine the outcome, risk factors,~     clinical characteristics and demographics of patients with acute PE and to identify possible~     demographic and clinical factors associated with prognosis.~   "
93049|NCT01839253|"~     For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators~     premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia~     and the rebound hypertension due to hypotensive anesthesia, enabling us to compare~     hemodynamic stability and reduction of anesthetic agents during the operation.~   "
93050|NCT01839240|"~     This phase I trial studies the side effects and best dose of azacitidine when given together~     with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute~     myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and~     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Azacitidine may also help~     cytarabine and mitoxantrone hydrochloride work better by making the cancer cells more~     sensitive to the drugs~   "
93051|NCT01839227|"~     Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients~     undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides~     information on the occurrence of cerebral desaturation resulted in POCD. But evidence of~     POCD after general surgery has been lacking. Especially, the prone position is used~     primarily for surgical access to the posterior spine, if there is any significant lowering~     of the legs or tilt of the entire table, venous returns may be decrease or augmented~     accordingly. The purpose of this study was to examine the relationship between POCD and~     intra-operative cerebral oxygen saturation after spine surgery in elderly patients.~   "
93052|NCT01839214|"~     This study will examine the safety and efficacy in subjects with mild to moderate ulcerative~     colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and~     other assessments.~   "
94233|NCT01823900|"~     This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug~     of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and~     Olmesartan (reference formulation) for single dose in healthy volunteers~   "
93053|NCT01839201|"~     Hypothesis: By employing suggestions before the induction of narcosis dreams may be evoked~     and their content may be directed.~      The main goal of suggestive techniques in the perioperative phase is to turn the content of~     dreams toward a favourable direction that is considered a pleasant event by the patient. So~     far little attention has been paid to the administration of perioperative psychological~     methods that may meet these requirements.~      Along these lines, in the present study we intended to assess whether dream recalls can be~     influenced by two different psychological methods administered in the preoperative setting~   "
93054|NCT01839188|"~     To evaluate the immune response and the safety of a primary series schedule that includes~     V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age~      Primary objectives~        -  To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B one~          month after completion of the mixed schedule~        -  To demonstrate that the mixed schedule induces acceptable responses for Hib one month~          after completion of the mixed schedule~      Secondary objectives~        -  To describe the antibody response to all PR5I antigens one month after completion of~          the mixed schedule~        -  To describe the antibody response to meningococcal serogroup C (MenC) conjugate vaccine~          one month after the second dose of MenC vaccine~        -  To describe the safety profile after each dose of study vaccines administered~   "
93055|NCT01839175|"~     Primary Series Primary objectives~        -  To demonstrate that the concomitant administration of the hexavalent vaccine with a~          meningococcal serogroup C conjugate vaccine is non inferior to the administration of~          the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection~          rate for hepatitis B one month after the third dose of the hexavalent vaccine~        -  To demonstrate that the concomitant administration of a MenC vaccine with the~          hexavalent vaccine induces an acceptable response for MenC in term of seroprotection~          rate (SPR) one month after the second dose of MenC~      Booster Primary objectives~      - To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a~     meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of~     age or given separately.~   "
93056|NCT01839162|"~     During percutaneous coronary interventions standard operator radio-protection is generally~     ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded~     glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a~     bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield~     on the patient, the radiation dose adsorbed by operators was significantly reduced even if~     was higher compared to transfemoral approach. No studies evaluated the effect of both~     adjunctive shields placed in the same patient.~      Aim of our randomized study is to evaluate if the combination of a shield drape on the~     patient right arm and a pelvic lead shield during transradial percutaneous coronary~     procedures may reduce the radiation dose adsorbed by operators compared to the use of only~     one shield or none.~      All patients who underwent to percutaneous coronary diagnostic or interventional procedures~     will be enrolled in this randomized study. Eligible patients will be randomized (using a~     computer generated randomization sequence) in 4 groups:~        1. use of a pelvic shield drape~        2. use of a shield drape on the patient right arm~        3. use of a pelvic shield drape and a shield drape on the patient right arm~        4. Any adjunctive shield drape (only standard radio-protection) For each group a further~          internal randomization will be performed in order to compare the right or left radial~          transradial approach.~      Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax~     level outside the lead apron. Since December 2013 the operators are equipped with a further~     dosimeter at head level.~      Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by~     operators and detected by the electronic dosimeters.~      Secondary end-point are:~        1. Radiation dose adsorbed by operators according to the radial access (right versus left)~        2. Radiation dose adsorbed by the patients~        3. Radiation dose adsorbed at head level.~   "
93057|NCT01839149|"~     This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high~     frequency episodic migraine and chronic migraine.~   "
93058|NCT01839136|"~     Background: The cost for the treatment of infertility are limiting for the health care~     access, particularly if we consider that the success rate per cycle is approximately 35%.~     Alternative regimens for controlled ovarian stimulation (COS)have been described in the~     medical literature, that lead to a lower cost, fewer injections and less risk of adverse~     events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report~     excellent results with less manipulation as possible, which reduces the cost of laboratory~     of human and ethically be considered less complicated once fertilization occurs in the~     uterus and not in vitro.~      Objectives: The main objective is to compare the reproductive outcomes between intrauterine~     transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the~     average number of eggs that are raised when using an EOC reduced cost.~      Methods: This study will be conducted in the area of Human Reproduction, Department of~     Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study~     with random allocation of the participants in a 1:1 ratio, and we plan to include 100~     participants. All participants will undergo an EOC reduced cost. We will compare the chance~     of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman~     allocated and to estimate the number of oocytes retrieved considering all participants.~   "
93059|NCT01839123|"~     The purpose of the study is to evaluate residual limb circulation and skin health associated~     with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will~     be compared to a vacuum prosthetic socket.~   "
93060|NCT01839110|"~     This study is looking to see if giving ranolazine to subjects on stable pulmonary~     hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would~     improve their outcome. This study is accompanied by a baseline comparison of the metabolic~     profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.~   "
93061|NCT01839097|"~     The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for~     belinostat when combined with CHOP regimen and establish the recommended belinostat dose for~     the Phase 3 study.~   "
93062|NCT01839084|"~     Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a~     nephroprotection after partial nephrectomy.~   "
93063|NCT01839071|"~     The purpose of this study is to investigate if patients with coronary heart disease have~     higher risk to develop diabetes mellitus among the following two years.~      The examination of biomarkers taken from blood and fat issue shall provide which factors~     could be responsible for development of diabetes mellitus.~   "
93077|NCT01838889|"~     This study is an exploratory randomized controlled trial (RCT) of a group psychological~     intervention for postnatal depression in British mother's of south Asian origin. The aim is~     to evaluate the efficacy of a group psychological intervention (PHP) based on the principles~     of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is~     that depressed British women of South Asian origin receiving the group intervention will~     show significant improvements in terms of severity of depression as compared to the~     treatment as usual (TAU) control group.~   "
93064|NCT01839058|"~     Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly~     understood. Some evidence suggests it may be related to sustained esophageal contractions~     (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a~     trigger for SECs and results in shortening of the esophagus. In this study, the~     investigators plan to prospectively evaluate esophageal shortening responses to acid in a~     group of patients with NCCP compared to controls. The investigators will use high resolution~     esophageal manometry coupled with acid infusion to evaluate shortening. The investigators~     hypothesize that at least a subset of patients with NCCP will have an exaggerated esophageal~     shortening response to acid which correlates with symptom production. If our hypothesis~     proves true, this may lead to a future therapeutic target in the treatment of these~     patients.~   "
93065|NCT01839045|"~     The major purpose of this study is to evaluate a laboratory developed test that measures~     multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker~     results along with your personal medical profile will be evaluated to determine your risk~     for the presence of a malignancy in the breast as compared to your breast evaluation~     assessment conducted by your physician.~   "
93066|NCT01839032|"~     Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and~     NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non~     change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more~     cycles during RT(66 Gy/6.5 w).~   "
93067|NCT01839019|"~     The purpose of the study is to evaluate the safety and tolerability of escalating single~     doses of ODM-102 in healthy volunteers~   "
93068|NCT01839006|"~     The purpose of this study is to assess the clinical significance of supranormal differential~     renal function (DRF) in the recovery of unilateral hydronephrosis (HN) after surgery,~     pediatric patients who underwent pyeloplasty for ureteropelvic junction obstruction (UPJO)~     who showed supranormal DRF (> 55%) in the DTPA renography will be analyzed.~   "
93069|NCT01838993|"~     We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately~     before induction.~   "
93070|NCT01838980|"~     Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby~     integrating colon cleansing, screening and treatment into one procedure. The device creates~     turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the~     system.~   "
93071|NCT01838967|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10~     mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.~   "
93072|NCT01838954|"~     Due to constant strain the joints of the hands are frequently affected by osteoarthritis~     (OA).~      Short-wave diathermy (SWD) is a form of electromagnetic therapy, which causes movement of~     ions, distortion of molecules, and creation of eddy currents and as a result heat is~     produced in deep tissue. Its claimed mechanism of action includes inducing an~     anti-inflammatory response, reducing joint stiffness, stimulating connective tissue repair,~     and reducing muscle spasm and pain.~      Since the available studies were performed to study the large weight-bearing joints only,~     there is a lack in scientific evidence for the efficacy of SWD in hand OA.~      The aim of this randomized, double blind, placebo-controlled study is to evaluate the effect~     of SWD on:~      joint function in patients with hand OA. joint pain in patients with hand OA. grip strength~     in patients with hand OA. quality of live in patients with hand OA.~   "
93073|NCT01838941|"~     The PBD are a rare group of inherited disorders due to the failure to form functional~     cellular peroxisomes. Most patients have progressive hearing and visual loss, leading to~     deafness and blindness, as well as neurological deterioration. There are no therapies for~     this disorder. A misfolded protein with residual function, PEX1-Gly843Asp, represents one~     third of all mutant alleles. Using patient cell lines with this mutation, we reported the~     recovery of peroxisome functions by treatment with Betaine, acting as a nonspecific chemical~     chaperone for the misfolded PEX1 protein. Betaine, or trimethylglycine, is a Health Canada~     and FDA approved orphan drug for the treatment of homocystinuria and is used by us safely~     and regularly in genetic medicine. We will perform a 6 month pilot study with 12 patients to~     test the hypothesis that Betaine, at recommended doses, can recover peroxisome biochemical~     functions in blood.~   "
93074|NCT01838928|"~     Background: The use of ultrasound in regional anesthesia enables a reduction in the local~     anesthetic volume. The present study aimed to determine the minimum effective concentration~     (EC50 and EC95) of bupivacaine for axillary brachial plexus block (ABPB). Methods: Following~     approval by the Research Ethics Committee, patients with a physical condition of I or II~     according to the American Society of Anesthesiologists, between 21 and 65 years of age were~     recruited and subjected to elective surgery of the hand and ABPB. The concentration of the~     anesthetic was determined using a step-up/step-down method and was based on the outcome of~     the preceding block.~   "
93075|NCT01838915|"~     A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue~     (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier,~     changes in gut microbiota, increased bacterial translocation and persistent immune~     activation, changes that are not restored after the initiation of antiretroviral therapy.~     The investigators hypothesize than an intervention targetting the enterocyte barrier and the~     gut microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and~     improve markers of bacterial translocation, inflammation, immune activation and endothelial~     dysfunction.~   "
93076|NCT01838902|"~     In this study, the investigators are interested to know if lower doses of Primaquine~     together with dihydroartemisinin-piperaquine can produce a similar effect of clearing both~     sexual and asexual parasites in asymptomatic carriers compared to the recommended dose of~     primaquine but with a decreased risk of haemolysis.~      Children (> 1 year) and adults with normal Glucose-6-phosphate dehydrogenase enzyme levels~     but with asexual Plasmodium falciparum parasites on the day of screening will be invited to~     take part in this study.~   "
93078|NCT01838876|"~     The objective of this study is to evaluate the long-term safety and tolerability of~     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with~     Major Depressive Disorder (MDD).~   "
93079|NCT01838863|"~     Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of~     severely injured trauma patients are found to be coagulopathic and forty percent of the~     mortality following severe injury is due to uncontrollable hemorrhage in the setting of~     coagulopathy. It has been established that early administration of fresh frozen plasma~     decreases mortality following severe injury, replacing lost coagulation factors, improving~     the coagulopathy and restoring blood volume. This study will determine if giving plasma to~     severely injured trauma patients during ambulance transport versus after arrival to the~     hospital will help reduce hemorrhage, thus decreasing both total blood product~     administration and mortality.~   "
93080|NCT01838850|"~     CS-8635 combines three widely prescribed antihypertensive medications, olmesartan~     medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure.~     The purpose of the study is to evaluate the efficacy and safety of triple therapy with~     CS-8635 compared with dual therapy in Korean patients with hypertension not controlled with~     dual fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in~     this study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ;~     Double blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching~     placebo vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label~     extension period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg~     (CS8635 20/5/12.5mg).~   "
93081|NCT01838824|"~     This pilot study will document the efficacy of a behavioral intervention for Processing~     Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been~     successful used in the aging population in several studies. This study will (1) apply a~     treatment protocol for PS impairments, well-validated in aging, to persons with MS with~     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess~     the effectiveness of the intervention utilizing global measures of daily life, including an~     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in~     that it will be the first to evaluate the efficacy of a highly-manualized structured~     behavioral treatment for processing speed deficits in persons with MS utilizing the optimal~     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence~     of PS deficits in the MS population and the significant impact such deficits have on~     everyday functioning, public safety, and overall quality of life, the identification of an~     effective intervention for PS deficits in MS could have a profound impact on the population~     and society as a whole.~   "
93082|NCT01838811|"~     This pilot study will document the efficacy of a behavioral intervention for Processing~     Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has~     been successful used in the aging population in several studies. This study will (1) apply a~     treatment protocol for PS impairments, well-validated in aging, to persons with TBI with~     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess~     the effectiveness of the intervention utilizing global measures of daily life, including an~     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in~     that it will be the first to evaluate the efficacy of a highly-manualized structured~     behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal~     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence~     of PS deficits in the TBI population and the significant impact such deficits have on~     everyday functioning, public safety, and overall quality of life, the identification of an~     effective intervention for PS deficits in TBI could have a profound impact on the population~     and society as a whole.~   "
93083|NCT01838798|"~     This is a prospective, single-center, pilot, cohort study. The first phase of this study is~     observational and the usual care of patients is maintained during the ICU stay, except for~     an interview with a psychologist preceding patient discharge. A phone interview at 2 months~     and a visit with a psychologist at four months after ICU discharge are specific to the~     study.~      The main objective of this study is to make a first estimate of the percentage of patients~     (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence /~     absence of cognitive impairment will be determined by the D2 test.~   "
93084|NCT01838785|"~     A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years~     of age may be eligible for this study. Candidates are screened with a medical history and~     physical examination, and blood test.~   "
93085|NCT01838772|"~     The purpose of this study is to assess the effectiveness and tolerability of hepatitis C~     virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia~     through a pilot model of care for treatment of HCV in resource-limited settings.~   "
93086|NCT01838759|"~     We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of~     hyponatremia~   "
93087|NCT01838746|"~     Young patients requiring myocardial revascularization are generally considered at low~     operative risk, but data on their immediate and late outcome are scarce. The decision-making~     process in these young patients is complicated by the potentially aggressive nature of~     premature coronary artery disease and their likely long expectancy of life, which expose~     them to a significantly higher risk of recurrent coronary events as well as the need of~     repeat revascularization. The lack of data on long-term outcome as well as on operative~     details (in particular, on the use of arterial grafts) and peri- and postoperative~     medication prevent any conclusive results on the durability either of coronary artery bypass~     grafting (CABG) or of percutaneous coronary intervention (PCI) in these young patients.~     Furthermore, recent advances in stents technology as well in peri- and postoperative medical~     treatment indicate the need a comparative study to define the baseline characteristics of~     patients aged < 50 years undergoing either PCI or CABG and to evaluate their current~     immediate and late outcome.~   "
93097|NCT01838616|"~     This was a clinical effectiveness trial designed to compare the effectiveness, safety, and~     tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone~     prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with~     a neuropathic pain component.~      Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol~     and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus~     oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics~     with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the~     neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.~   "
93088|NCT01838733|"~     Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The~     definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the~     association between desaturations and perioperative outcome, and the mechanistic~     explanations of cerebral desaturations remain unexamined. This study seeks to identify the~     true incidence and magnitude of cerebral desaturations in high-risk non-cardiac surgical~     patients and the association between desaturations and perioperative outcome.~      The investigators will attempt to determine the following (1) The proper definition,~     incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac~     surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with~     alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin~     concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of~     decreased rSO2 with relevant perioperative.~      The investigators will also analyze a panel of inflammatory biomarkers to determine if these~     biomarkers have the ability to predict postoperative complications.~      The investigators will study 200 high-risk patients undergoing high-risk non-cardiac~     surgery. The investigators will determine the incidence and severity of decreases in rSO2,~     the associated factors with the occurrence of decreased rSO2, and the relationship between~     decreases in rSO2 and adverse perioperative outcome with a composite of well defined~     perioperative complications such as death, myocardial infarction, cerebrovascular accident,~     acute kidney injury, delirium, postoperative infections, and the need for mechanical~     ventilation.~   "
93089|NCT01838720|"~     To evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency~     ablation assisted enucleation of T1a renal cell carcinoma in comparison with the~     conventional laparoscopic partial nephrectomy.~   "
93090|NCT01838707|"~     we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL +~     Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and~     mobilization maneuvers.~   "
93091|NCT01838694|"~     The primary objective of the study is to evaluate the safety, tolerability, and efficacy of~     4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.~   "
93092|NCT01838681|"~     To evaluate the maintenance of efficacy and safety during long-term treatment with~     brexpiprazole as an adjunctive treatment for adult subjects with Major Depressive Disorder~     (MDD)~   "
93093|NCT01838668|"~     This is a multicenter study conducted in 2 parts:~      The primary objective in Part I of this study is to determine the efficacy of BG00012~     (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion~     activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at~     Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)~     including participants from the Asia-Pacific region.~      The secondary objectives in Part I of this study in this study population are to determine~     whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the~     cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the~     number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24~     compared with Baseline.~      The primary objective in Part II (open label) of this study is to evaluate the long-term~     safety profile of BG00012 in eligible participants from Part I.~   "
93094|NCT01838655|"~     Background:~      - Oculocutaneous albinism, type 1B (OCA1B) is a genetic disease caused by problems in the~     gene that makes tyrosine. Tyrosine is an amino acid needed to produce pigment in the skin,~     hair, and eyes. People with OCA1B have pale skin, white hair, and light-colored eyes.~     Pigment in the back of the eye helps vision, so people with OCA-1B often have visual~     problems. Researchers want to see if a drug called nitisinone can help improve eye~     pigmentation and vision in people with OCA1B. Nitisinone is approved for treating a related~     genetic disease that causes problems with tyrosine, so it may help people with OCA1B.~      Objectives:~      - To see if nitisinone can help improve eye pigmentation and vision in people with OCA1B.~      Eligibility:~      - Individuals at least 18 years of age who have OCA1B.~      Design:~        -  This study will last about 18 months. It requires eight outpatient visits, each about 3~          months apart. Each visit will require 1 to 2 days of testing.~        -  Participants will be screened with a physical exam, eye exam, and medical history. They~          will have additional vision and neurological tests. They will be tested to see how~          their brain and retinas respond to light. They will also take hair and blood samples,~          and answer questions about diet.~        -  Participants will receive the study drug. They will take one pill a day for 1 year.~          They will keep track of the dose in a study diary.~        -  At the outpatient visits, participants will have the following tests:~        -  Medical history and physical exam~        -  Neurological and eye exams~        -  Retina function tests~        -  Tests of the skin and brain's response to light~        -  Blood and urine tests~        -  Dietary consultation~        -  Visual function questionnaire.~        -  After the end of the study, participants will return to the care of their regular eye~          doctor.~   "
93095|NCT01838642|"~     Background:~        -  Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a~          hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy.~        -  MTC arises from the parafollicular C-cells of the thyroid.~        -  Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in~          virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of~          sporadic cases.~        -  Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in~          the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are~          needed for previously untreated patients as well as patients who have become refractory~          to other molecular targeted therapeutics (MTTs).~        -  Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for~          chronic myelogenous leukemia~      (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a~     potent inhibitor of RET kinase.~      Primary Objective:~      -To determine the objective overall response rate (complete response [CR] + partial response~      [PR] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment~     of patients with advanced or metastatic MTC previously treated with cabozantinib and~     vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations.~      Eligibility:~        -  Patients must have histologically confirmed, unresectable, locally advanced or~          metastatic MTC, with measurable disease by RECIST criteria.~        -  Patients must have disease amenable to biopsy and be willing to undergo biopsy for~          molecular analysis, and also have adequate archival material from their thyroidectomy~          or from a tumor biopsy obtained prior to beginning any systemic therapy.~        -  Patients must have failed or been intolerant to prior treatment with both cabozantinib~          and vandetanib.~        -  The last dose of prior systemic therapy must be more than 28 days prior to the first~          dose of ponatinib~        -  Radiation therapy is permitted if the last treatment was received more than 28 days~          prior to the first dose of ponatinib.~      Design:~        -  Open label phase II trial with 2 treatment groups:~        -  RET mutation positive MTC, previously treated with vandetanib and cabozantinib~        -  RET mutation negative MTC, previously treated with vandetanib and cabozantinib~        -  Patients will receive ponatinib 30 mg orally daily until disease progression or until~          the development of intolerable side effects.~        -  Tumor response will be assessed by RECIST 1.1 criteria at 8 weeks and then every 12~          weeks thereafter. After one year on study, tumor response will be assessed every 16~          weeks.~        -  Patients will have a biopsy of their MTC for molecular analysis prior to initiating~          treatment with ponatinib. Patients will also have a biopsy of their MTC at the time of~          tumor progression, should that occur.~   "
93096|NCT01838629|"~     1. acquire the environmental iodine status of Hangzhou~        2. acquire the iodine status of population in Hangzhou~        3. acquire the prevalence of thyroid diseases in Hangzhou~        4. explore the association between iodized salt and thyroid disease~   "
93098|NCT01838603|"~     There are quite a few qualitative studies done to find out patients experience of chronic~     pain. There are no studies on what the patients feel and what thoughts and feelings arise in~     the patients that are exposed to interventional pain management. This study aims to~     illuminate how it is to live through an interventional pain management program.~   "
93100|NCT01838577|"~     The investigators wish to document the distribution of EGFR somatic mutations, and assess~     the relationship between specific genotype, clinical demographic, therapy, and survival, in~     a large cohort of EGFR mutant NSCLC.~      The investigators also wish to comprehensively investigate the relationship between germline~     DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association~     Studies) and candidate gene approach, and explore the relationship between germline DNA and~     clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI~     (Tyrosine Kinase Inhibitor) outcome.~   "
93101|NCT01838564|"~     Over 50% of children dying from cancer still suffer from symptoms that could be effectively~     alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms~     Technology (PediQUEST) Study was to evaluate whether providing feedback to families and~     providers about how the child is feeling improved child distress and quality of life (QoL)~     in children with advanced cancer.~      PediQUEST is a computerized survey that asks the child and/or parents how the child has been~     feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other~     aspects of life, such as school and friends, are going. After the survey is complete a~     report that summarizes patient/parent answers is printed. When a child reports moderate to~     high distress from any symptom an email is automatically sent to the primary providers~     (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care~     services) alerting them about the child's distress.~      In this study we evaluated whether using PediQUEST and providing printed reports to parents~     and providers reduced distress and improved quality of life in children with advanced~     cancer. In addition, we wanted to understand whether it was feasible to carry out a~     randomized controlled trial in children with advanced cancer. Finally, the data collected,~     will be used to describe the natural history of symptoms and quality of life as reported by~     the children.~      Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey~     at most once a week. A random half of the children received the feedback intervention, i.e.~     patients, parents, and providers received printed reports (and emails if the child was in~     distress). The other half only completed the PediQUEST surveys and did not receive reports.~     We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST~     reports had any effect on child distress and quality of life.~   "
93102|NCT01838551|"~     The primary objectives of this study are to evaluate the efficacy of ascending doses of~     COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing's Syndrome by~     assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the~     range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper~     limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior~     dose increase in that phase.~   "
93103|NCT01838538|"~     To study the efficacy and safety of intraperitoneal injection bevacizumab combined with~     intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of~     ovarian cancer. To analyze the clinical significance of the concentration change of vascular~     endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection~     bevacizumab~   "
93104|NCT01838525|"~     To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and~     prognosis of patients with sepsis, and then compared with C-reactive protein (CRP),~     procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health~     Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164~     patients were enrolled in the study, including 25 cases with systemic inflammatory response~     syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe~     sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive~     protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on~     the day of admission to intensive care unit (ICU).~   "
93105|NCT01838512|"~     This is a non-interventional observational study aimed at understanding the real world~     effectiveness of novel agents used in treating multiple myeloma and their impact on~     patient-reported outcomes. This study will collect information that is already in medical~     records regarding treatment and diagnostic procedures. Patients are asked to complete~     questionnaires for patient-reported outcome measures.~   "
93106|NCT01838499|"~     The purpose of this study is to gain initial evidence for the safety, tolerability and~     efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis~     suppurativa~   "
93107|NCT01838486|"~     Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention~     (BTD).~   "
93108|NCT01838473|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
93109|NCT01838460|"~     To compare each subject's AUCinf, after administration of one single dose of 6 mg of~     Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of~     SS containing 16 mg nicotine.~   "
93110|NCT01838447|"~     Our research group has shown that almost all children with congenital heart disease (CHD)~     are vitamin D deficient following heart surgery. This work strongly suggests that the~     vitamin D intake presently recommended for healthy children, and also given to children with~     CHD, is inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there~     have been no studies investigating any other vitamin D dose in children with heart disease.~     Recently, a higher dose of vitamin D intake has been approved (by the Institute of Medicine~     and Health Canada) and recent work on healthy children has shown it to be safe. The~     objective of this study is to determine whether this recently approved higher dose of~     vitamin D can safely reduce the number of children who are vitamin D deficient following~     surgery. This dose evaluation study will also evaluate whether it is possible to perform a~     large study (across Canada) to determine whether vitamin D supplementation can improve~     outcomes following surgery. It is hypothesized that a daily high dose vitamin D regimen,~     modeled on the Institute of Medicine daily upper tolerable intake level (UL), will~     significantly reduce vitamin D deficiency following CHD surgery, when compared with usual~     intake.~   "
93111|NCT01838434|"~     This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without~     idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.~   "
94234|NCT01823887|"~     The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve~     stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with~     symptomatic heart failure.~   "
93113|NCT01838408|"~     This study aims to provide safety and efficacy data comparable to available over-the-counter~     bowel preparations prior to colonoscopy. While there are many bowel preparations available,~     most of them remain expensive and require prescription from a health provider. The~     investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more~     accessible way (over-the-counter).~      To accomplish this goal, the investigators decided to evaluate the proposed EZ2go~     combination versus currently available over-the-counter bowel preparations. The~     investigators believe the EZ2go kit will not be inferior to current FDA approved~     over-the-counter bowel preparations.~   "
93114|NCT01838395|"~     The goal of this clinical research study is to learn if BL-8040 in combination with~     cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia~     (AML) that has relapsed or did not respond adequately to previous treatment. The safety of~     the study drug combination will also be studied.~   "
93115|NCT01838382|"~     Laparoscopic operative procedures have revolutionized gynecological surgery. These have~     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter~     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues~     to be one complication, which results in an unpleasant experience for the patient and at~     times causes a delayed discharge. There are few studies about pain characteristics as one of~     laparoscopic hysterectomy complications. The purpose of this study is to investigate the~     prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in~     patients undergoing total laparoscopic hysterectomy.~   "
93116|NCT01838369|"~     The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients~     diagnosed with smoldering multiple myeloma.~   "
93117|NCT01838356|"~     The purpose of the study is to examine if blood flow in the brain before coronary artery~     bypass graft surgery has an effect on depression after surgery.~      The main hypothesis of the study states that pre-surgical blood flow in the brain will be an~     independent risk factor for depression after surgery after adjusting for other risk factors~     such as gender, pre-CABG depression, social support, medical comorbidity burden,~     socioeconomic status, and neuroticism.~   "
93118|NCT01838343|"~     Rapid response team systems have been implemented in numerous hospitals throughout the world~     with the goal of improving the identification and safety of hospitalized patients who are~     clinically deteriorating. Despite their theoretical benefit, rapid response systems have not~     been proven in the medical literature to ultimately change outcomes.~      The traditional physical exam is helpful in evaluating and treating unstable medical~     patients during these types of events but has significant limitations of deceased~     sensitivity and specificity of findings. Ultrasound is a known tool for more accurately~     assessing patients in shock and respiratory failure in the ICU by highly trained operators~     but to the investigators knowledge has not been studied in the setting of rapid response~     events on hospital wards by critical care fellows after focused training. The investigators~     aim to assess the impact of ultrasound performed by critical care fellows during rapid~     response events.~   "
93119|NCT01838330|"~     Loss of kidney function results in accumulation in the blood of molecules that are either~     excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic~     Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial~     metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and~     excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity.~     Indeed, these URMs have been linked to increased levels of inflammation markers, chronic~     kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/~     or hemodialysis patients. Therefore, interventions that target the production or absorption~     of URMs from the gut might decrease inflammation and oxidative stress that are commonly seen~     in the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III)~     data show that high dietary fiber intake is associated with decreased serum levels of~     C-reactive protein (CRP) in those with and without CKD and these associations are much~     stronger in the CKD population. A possible explanation of this effect is that a high fiber~     diet in CKD patients modulates the bacterial production, intestinal absorption and finally~     the serum levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in~     decrease in inflammation.~      OBJECTIVES:~      Hypothesis:~        1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive~          protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage~          4 CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2~          CKD (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by~          the higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4~          CKD, and~        2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand~          name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum~          levels of inflammation markers and urinary levels of transforming growth factor~          (TGF)-β, a marker of kidney fibrosis.~   "
93120|NCT01838317|"~     This study is being done to determine whether or not addition of the oral medication,~     pioglitazone to standard chemotherapy, results in improvement of blood tests that measure~     the body's ability to utilize sugar (glucose and insulin metabolism). In addition the~     investigators want to determine whether or not treatment with pioglitazone results in (1)~     improvement in the size of the tumor, (2) weight gain, (3) improved ability to function~     during the day and (4) quality of life.~   "
93121|NCT01838304|"~     Endoscopic sedation requires titration of propofol to deep sedation without minimum~     overshoot into general anesthesia. This skill is demanding and acquired slowly. Probability~     Ramp Control (PRC) simplifies this by providing the clinician with a simple infusion~     sequence that permits gradual titration of propofol. The purpose of this study is to compare~     the performance of this technology to that of experienced anesthesia providers in endoscopic~     sedation.~   "
93122|NCT01838291|"~     Observational, open label, prospective, multi-center, post-marketing drug surveillance~     program.~   "
93123|NCT01838278|"~     - Justification: Prematurely born children have an increased prevalence of neurodevelopment~     problems in the first two years. Knowledge regarding the effects of early intervention~     programs is essential to the follow up of these children and the families.~      -Hypothesis: The Vojta Therapy Model showed beneﬁcial effects on motor development outcomes~     reported by Bayley Sales of Infant Development-Second Edition, in the first 18 months of~     life on European sample.~   "
93124|NCT01838265|"~     1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more~          accurate sampling of the tumors and therefore will increase the rate of progression~          on early (first and second) surveillance biopsies and decrease the rate of~          progression on late (third and further) surveillance biopsies compared to Transrectal~          Ultrasound-guided biopsies.~        2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or~          MRI-guided and Transrectal Ultrasound-guided biopsies.~        3. Biomarker expression levels will correlate with biopsy progression.~   "
93125|NCT01838252|"~     Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can~     result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic.~     Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be~     damaging to the cornea. The definitive therapy for lid retraction is surgical, and often~     involves complicated procedures including tissue grafting.~      Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by~     subcutaneous injection and volume addition. These gels have gained wide popularity in for~     cosmetic applications in filling volume deficit areas. Functional applications in the~     periorbital area have also been described including the filling of volume deficit~     anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found~     HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.~      The purpose of this investigation is to define the clinical utility of HAG correction of~     lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on~     cornea) and qualitative effects (symptom severity).~      Our hypothesis is that HAG correction of lower eyelid retraction will improve patient~     comfort, clinical signs of dry eye and aesthetic self image.~   "
93126|NCT01838239|"~     The purpose of this study is to examine the variation between individuals in blood lipid~     metabolites, and the changes in these metabolites in response to omega-3 fatty acids in~     patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is~     that measuring variation among individuals and changes in response to omega-3 fatty acids~     comprehensively by using metabolomics will help to identify those individuals who are~     responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory~     intervention.~   "
93127|NCT01838226|"~     Prevention of cardiovascular disease is a primary focus of the Secretary's New Models of~     Care Transformational Initiative. However, prevention has been hard to accomplish. The VA is~     committed to using group visits to address a wide array of primary care problems. Coaching~     is a method to help Veterans set and reach health goals by helping them overcome barriers to~     behavior change. Coaching can be performed one-on-one or in groups. This study will test the~     effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular~     risk. GPCs will focus on changing a behavior of the patient's choice that is likely to lead~     to improvements in heart disease risk. The coach will adopt a problem-solving approach to~     helping Veterans make these improvements. The primary outcome will be change in 10-year risk~     of major cardiac event; the investigators will also assess improvements in food choice,~     physical activity and weight.~   "
93128|NCT01838213|"~     This project aims at investigating the duration of human fecal carriage of bacteria~     harboring plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases~     (ESBL), risk factors for infections with such bacteria and persistence, mobility and spread~     of ESBL in the environment and within households. It also aims to compare different methods~     of detecting ESBL carriage and treat patients with urinary tract infection caused by these~     bacteria.~   "
93129|NCT01838200|"~     This is an open-label, dose-escalation, non-randomized, phase I study in patients with~     histologically confirmed Stage III or IV melanoma and at least three metastatic cutaneous or~     subcutaneous lesions suitable for: intralesional (IL) injection (1 lesion), accessible for~     biopsy (1 lesion), and response evaluation by RECIST (v1.1) and modified RECIST (irRC) (1~     lesion). The primary objective is to determine whether IL administration of BCG followed by~     intravenous (IV) infusion of ipilimumab is safe. Ipilimumab (YERVOY®) is the monoclonal~     anti-CTLA-4 antibody approved by the FDA and TGA as anticancer therapy for melanoma.~     Secondary objectives of the study are: a) clinical efficacy, to document whether this~     combination therapy induces tumour responses; and b) immunogenicity, to identify if the~     combination induces immune responses against the tumours. All patients will be included in~     the analysis of efficacy and immunogenicity.~      Cohort 1 (9 patients with <10mm induration after tuberculin Purified Protein Derivative~     [PPD] test): Group 1 (3 patients) will receive one IL injection of 200 µl BCG containing~     0.16 - 0.64 x 106 cfu followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks,~     starting on day 36. Group 2 (3 patients) and 3 (n=3) will receive 200 µl BCG containing 0.8~     - 3.2 x 106 cfu and 4.0 -16.0 x 106 cfu, respectively, followed by the same ipilimumab~     regimen. Safety will be evaluated in this cohort.~      Cohort 2 (up to 9 patients with ≥10mm induration after PPD test): Enrolment will start after~     the final patient in Cohort 1, Group 1 has reached study week 7. Then enrolment can proceed~     in parallel for Cohort 2 and Cohort 1 Groups 2 and 3. Patients will receive 0.16 -0.64 x 106~     cfu BCG followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day~     36. Evaluation of safety in this cohort will be observational.~   "
93130|NCT01838187|"~     Currently there is no known effective treatment for patients with advanced stage~     neuroblastoma, pheochromocytoma, or paraganglioma who have relapsed or not responded to~     standard therapy. In previous studies that used 131I-MIBG as a potential anti-cancer~     therapy, a decrease in the size of tumors was seen in some of the children and adults. This~     research study will continue to evaluate the side effects of 131I-MIBG when treating~     children and adults with neuroblastoma, pheochromocytoma, or paraganglioma. The 131I-MIBG~     compound is intended to work by selectively delivering the radioactive iodine to the tumor~     cells, which is then intended to result in their destruction.~      The purpose of this research study is to:~        -  Make 131I-MIBG therapy available to patients with advanced neuroblastoma,~          pheochromocytoma, or paraganglioma~        -  Further assess the side effects of 131I-MIBG therapy~   "
93131|NCT01838174|"~     We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of~     Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting~     inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous~     methylprednisolone therapy on axonal injury following ON using ocular coherence tomography~     (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer~     (RNFL) thickness.~      The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified~     statistical analyses will compare the difference in the mean RNFL thickness at 6 months in~     the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean~     6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The~     secondary outcome measure will examine the frequency of optic nerves with RNFL swelling~     between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary~     outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary~     diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus~     inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups~   "
93209|NCT01837147|"~     Women who are overweight or do not exercise are at higher risk for breast cancer after~     menopause. This study will test a new electronic device that measures the body's movement~     and works alongside a website to help women increase their physical activity level. If~     effective, this system could be tested in larger studies aiming to reduce breast cancer risk~     by reducing or preventing obesity.~   "
93132|NCT01838161|"~     The proposed project develops a community and school-based intervention to enhance~     understanding of the importance all age-appropriate vaccinations, and uses an innovative,~     comprehensive approach (Project INSPIRE - Instilling Necessary Sickness Prevention with~     Immunizations Reaching Everyone) to ensure that all parents of adolescents are advised of~     all age-appropriate vaccines for sickness prevention. The investigator will develop a novel~     set of targeted video vignette persuasive informational decision aids (including target~     population representatives) to enhance lay understanding of recommended adolescent (or~     catch-up) vaccines. The Investigator will also partner with school districts to develop a~     replicable social marketing vaccination event program (Project INSPIRE) to encourage parents~     and teens to publicly vaccinate at community events and during drop-in school nursing clinic~     hours. The project will test the efficacy of the video-based health education intervention +~     standard of care to ideal standard of care (social marketing vaccination event program)~     approaches to immunize adolescents in this region.~   "
93133|NCT01838148|"~     The primary aim is to perform the largest study worldwide to evaluate novel biochemical and~     electrocardiographic signatures alone as well as in combination with the standard 12-lead~     exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint).~     The secondary aim is to evaluate these innovative tools in the risk prediction for the~     occurrence of cardiovascular death and acute myocardial infarction during long-term~     follow-up.~   "
93134|NCT01838135|"~     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important~     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel~     self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to~     determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use,~     confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in~     older adults compared to group-based information sessions; and 3. the study design is~     appropriate. This feasibility study will allow for study design and protocol refinement and~     will provide pilot data for an experimental trial.~   "
93135|NCT01838122|"~     Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes~     Association has suggested screening of women with PCOS for HbA1C.~   "
93136|NCT01838109|"~     Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition~     due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption~     function, and/or metabolic changes after surgery. The postoperative malnutrition is~     associated with low quality of life and seems to be related long-term nutritional status.~     This study is a multicenter, open-labeled prospective randomized clinical trial to examine~     the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal~     surgery by comparing the change of body weight and other nutritional parameters between the~     experiment group that is supplied with ONS and the control group without ONS.~   "
93137|NCT01838096|"~     This study will evaluate clinical outcome on patients who undergo cementless 4th generation~     ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total~     hip aArthroplasty (THA) in patients younger than 30 years.~   "
93138|NCT01838083|"~     Primary Objective:~      To demonstrate equivalence in exposure to insulin glargine given as test formulation T and~     reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC)~     doses~      Secondary Objective:~        -  To assess relative Pharmacodynamic activity of the insulin glargine test formulation T~          to the insulin glargine reference formulation R in steady state conditions after 6~          once-daily SC doses~        -  To assess the safety and tolerability of the test and reference formulations of two new~          insulin glargine formulations~   "
93139|NCT01838070|"~     This safety surveillance study is being conducted in accordance with Korea Food and Drug~     Administration (KFDA) Basic standard for reexamination of new drug.~      Primary objective:~        -  To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the~          routine practice, according to Korea Food and Drug Administration Basic standard for~          reexamination of new drug based on the pharmaceutical law in Korea.~   "
93140|NCT01838057|"~     To evaluate the impact of painPRIMER in a prospective six-month clinical investigation~     looking at clinical outcomes, health care professional and patient satisfaction, healthcare~     resource use, productivity and direct and indirect costs. The hypothesis is that early~     identification of the presence of neuropathic pain and back pain related comorbidities, to~     direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve~     patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery,~     thereby reducing costs and productivity loss associated with these inefficiencies.~   "
93141|NCT01838044|"~     The purpose of this study is to determine if treatment with celecoxib and pregabalin~     together would prove to be more effective in relief of pain than treatment with celecoxib~     alone in people who have chronic low back pain with a probable neuropathic component.~   "
93142|NCT01838031|"~     Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal~     subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome~     and cognitive function in the children.~   "
93143|NCT01838018|"~     The purpose of this study is to learn whether blood flow in the brain is normal in people~     with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data~     suggest a region of the brain called the globus pallidus (GP), a key region affected by~     PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be~     used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow~     in other brain regions as well as to healthy controls.~   "
93144|NCT01838005|"~     The goals of the proposed study are to: 1) test whether small, increasing cash payments to~     HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and~     receive proposed services, will increase the proportion of women who receive the most~     effective antiretroviral regimen they are eligible for by the time of delivery, and 2)~     elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade,~     and to what extent the conditional cash payment program addresses these factors.~      This intervention will be implemented and evaluated within our well-established PMTCT~     program in Kinshasa, Democratic Republic of Congo (DRC),~   "
93145|NCT01837992|"~     The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu)~     represent a unique and especially prescient challenge to malaria control and elimination.~      While the use of bed nets and other vector control and case management measures have~     achieved major advances in overall malaria control, the P. vivax and P. ovale species~     account for an ever-increasing burden of clinical disease.~      The lack of effective treatment of the hypnozoite stages of infection with these species~     result in ongoing relapses and a continuing reservoir of infection.~      The only known drug effective for treatment of the hypnozoite stage is primaquine; however~     the safe and effective dose of this drug in malaria treatment is still unclear.~      A recent study evaluated the safety and efficacy of two primaquine dosing regimens~     (0.25mg/kg and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to~     replicate this methodology in Vanuatu and Solomon Islands, to provide a more complete~     picture of primaquine efficacy and safety in each of the three countries of this region.~   "
93146|NCT01837979|"~     There are 26,600 Down Syndrome newborns every year in China. The economic burden of this~     disease is 65,000 USD for lifetime of every patient. The common prenatal screening and~     diagnosis procedure for fetal chromosomal abnormalities in China is maternal serum prenatal~     screening in second trimester followed by amniocentesis. The detection rate of MSS is~     70%-75% with 5% false positive rate. There are only 13.9% of pregnant women can receive~     prenatal screening testing in China. It is very urgent that we build a training system and~     convenient, efficient, cost-effective procedure suitable to rural China.~      The use of dried blood spots (DBS) technology in conjunction with the second trimester~     prenatal screening protocol has been proved to be as efficient as serum screening by our~     previous study. Noninvasive prenatal testing that uses cell free fetal DNA (cff DNA) from~     the plasma of pregnant women offers a tremendous potential for fetal chromosomal~     abnormalities. A positive test should be followed by invasive prenatal diagnosis to confirm~     the test results. Cff DNA is a good supplement to the DBS technology in rural China. A~     combination of the two methods can increase the screening rate and accuracy without~     increasing the demand of amniocentesis and cytogenetic test. This procedure with adequate~     training system should be suitable to rural China.~      Our study will build a training system for DBS and cffDNA prenatal screening procedure in~     Pinggu, Beijing. Two thousand pregnant women will receive prenatal screening. DBS sample~     will be collected in the second trimester, Cff DNA is offered to confirm the positive~     screening test results, and lastly amniocentesis is offered for confirmation of the test~     results. All of the pregnancy and neonatal outcomes will be followed. We can estimate the~     efficiency and cost-effectiveness of DBS followed with cff DNA screening procedure.~   "
93147|NCT01837966|"~     The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in~     breast surgery patients.~   "
93148|NCT01837953|"~     Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese~     individuals, and 30% to 50% of those participating in weight loss programs. BED, the most~     common eating disorder, is characterized by over-eating with loss of control (i.e., binge~     eating), but with no purging (e.g., vomiting).Our previous research indicates that the total~     health care costs for women with BED is 36% higher than the Canadian average for women of a~     similar age, and that health care costs significantly decreased following intensive~     treatment at our Centre. The main goal of our study is to inform the development of a~     stepped care approach to the treatment of BED. Stepped care involves providing easily~     accessible low intensity treatment first, and then providing more expensive intensive~     treatment second, if necessary. The second goal is to assess if a second more intensive step~     of treatment provides added value. Although stepped care for BED is suggested by a number of~     clinicians and researchers, no study adequately tests predictors of who might benefit from~     minimal treatment alone and who would require the more intensive second step. The results of~     this study will guide decision making regarding who benefits from stepped care, and will~     help to increase the accessibility, availability, and cost effectiveness of psychological~     treatments for BED.~   "
93149|NCT01837940|"~     The purpose of this study is to investigate the effect of a daily supplement consisting of~     the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65~     years and older.~   "
93150|NCT01837927|"~     This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as~     active control in COPD patients.~   "
93151|NCT01837914|"~     Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of~     children. The disease is believed to have several overlapping causes including large tonsils~     and small or narrow jaws. This prospective, randomized cross-over study will evaluate the~     effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the~     current standard of care which is surgical removal of the adenoids and tonsils.~      Patients will be evaluated by both an orthodontist and ENT physician, complete a series of~     questionnaires and undergo an overnight sleep study, both initially and after undergoing the~     randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea~     will then be crossed over and receive the other form of treatment. The levels of improvement~     to both subjective (questionnaire) and objective (overnight sleep study) measures of sleep~     apnea will then be compared.~      The null hypothesis is there is no significant difference in improvement between maxillary~     expansion and adenotonsillectomy in the objective and subjective outcome measures in~     children with mild to moderate obstructive sleep apnea.~   "
93152|NCT01837901|"~     The purpose of this study is to determine the long term effects of transcorneal~     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study~     (NCT00804102) the results of short term stimulation pointed to a positive effect on the~     visual field and other parameters. In this study, the patients will be stimulated with~     either 0%, 150% or 200% of the individually determined phosphene threshold.~   "
93153|NCT01837888|"~     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important~     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel~     self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if:~     1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate;~     and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for~     study design and protocol refinement and will provide pilot data for an experimental trial.~   "
93164|NCT01837745|"~     Open-label randomized phase III trial, using a non-inferiority comparison design. After~     randomization,patients will receive either post-operative radioiodine ablation with an~     activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation~     group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).~      The objective is to assess the non-inferiority of the proportion of patients without~     tumor-related event evaluated at three years after randomisation in the absence of~     radioiodine ablation (follow-up group) compared to the ablation group, in patients with~     low-risk differentiated thyroid cancer treated with total thyroidectomy with or without~     lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)~   "
93154|NCT01837875|"~     The goal of the proposed project is to enhance the Principal Investigator's research ability~     to conduct behavioral interventions for people with lupus. This includes intervention~     design, implementation, data collection and data analysis. The Intervention to Improve~     Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine~     whether a uniquely tailored intervention program can improve quality of life, decrease~     indicators of depression, and reduce perceived and biological indicators of stress in~     African American lupus patients. This study builds on three decades of work conducted in the~     field of arthritis self-management but differs in that the intervention mode, the disease~     (lupus), and the study population (African-Americans) are unstudied or understudied. The~     IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance~     (RE-AIM) model as its theoretical framework. This program has three specific aims. The first~     aim seeks to design a three armed randomized, wait list controlled trial that employs a~     patient-centered 'a-la-carte' approach that offers subjects a variety of modes of~     interaction, allowing them to choose as many or few as they wish. The second aim is to~     assess the intervention, using the RE-AIM model framework. The third aim, to be achieved~     before the first aim, is to use previously collected data to characterize patient-centric~     barriers to care in African-American lupus patients, in order to identify trends in patient~     needs and desires, as well as correlates of non-response and non-compliance that can be used~     in the development and refinement of the intervention.~   "
93155|NCT01837862|"~     This is a study to determine the safety and efficacy of the drug, mebendazole, when used in~     combination with standard chemotherapy drugs for the treatment of pediatric brain tumors.~     Mebendazole is a drug used to treat infections with intestinal parasites and has a long~     track record of safety in humans. Recently, it was discovered that mebendazole may be~     effective in treating cancer as well, in particular brain tumors. Studies using both cell~     cultures and mouse models demonstrated that mebendazole was effective in decreasing the~     growth of brain tumor cells.~      This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade~     gliomas are tumors arising from the glial cells of the central nervous system and are~     characterized by slower, less aggressive growth than that of high-grade gliomas. Some~     low-grade gliomas have a more aggressive biology and an increased likelihood of resistance~     or recurrence.~      Low-grade gliomas are often able to be treated by observation alone if they receive a total~     surgical resection. However, tumors which are only partially resected and continue to grow~     or cause symptoms, or those which recur following total resection require additional~     treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid~     astrocytomas, even when totally resected, will often be treated with chemotherapy. The~     current first-line treatment at our institution for these low-grade gliomas involves a~     three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However,~     based on our data from our own historical controls, over 50% of patients with pilomyxoid~     astrocytomas will continue to have disease progression while on this treatment. We believe~     that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide~     an additional therapeutic benefit with increased progression-free and overall survival for~     low-grade glioma patients, particularly for those with pilomyxoid astrocytomas.~      High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is~     radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but~     with disappointing results. For high-grade gliomas this study will add mebendazole to the~     established combination of bevacizumab and irinotecan to determine this combinations safety~     and efficacy~   "
93156|NCT01837849|"~     To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP)~     with dobutamine on acute decompensated heart failure patients with different blood BNP~     levels~   "
93157|NCT01837836|"~     The purpose of this study is to assess the drinking water handling practices at household~     level and to determine the effect of health education on the drinking water handling.~     Participants from study villages, mainly homemakers, school children and water tank~     operators who are willing to participate, will be targeted.~      Baseline assessment of household practices related to water will be done. Followed by a~     health education regarding the healthy practices will be given to them. Practice of~     household water chlorination will be promoted. The healthy behavior will be reinforced~     through reminders and community activities of self help groups for one year.~      The study participants will be benefited from survey in terms of~        1. Improved knowledge and practices of drinking water handling~        2. Risk reduction of water borne illness to family members~   "
93158|NCT01837823|"~     Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well~     known that the reduction of cholesterol levels by statin therapy is associated with~     significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II~     trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin~     respectively reduced progression of coronary atherosclerosis, even causing plaque regression~     of some lesions. CAD clinical events are related to plaque instability due to lipid content~     and activity within the atherosclerotic plaque. The investigators recently completed the~     YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was~     associated with a reduction in the amount of lipid in obstructive coronary plaques, as~     measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and~     build upon these results, and to provide mechanistic insights into the potential benefits of~     intensive statin therapy on atherosclerotic plaques.~   "
93159|NCT01837810|"~     The purpose of this study is to determine if ibuprofen use after electrocautery~     tonsillectomy increases the post-tonsillectomy hemorrhage rate.~      Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate.~      Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those~     receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics~     alone.~      Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug~     (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain~     management.~   "
93160|NCT01837797|"~     To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly~     patients with Major Depressive Disorder (MDD)~   "
93161|NCT01837784|"~     Guidelines recommend measuring end organ damage and in particular arterial stiffness in~     patients with hypertension. However, until now it was not possible to measure arterial~     stiffness with the use of simple methods. Recently, novel and innovative devices offering~     determination of arterial stiffness and central hemodynamics from simple and non-invasive~     arm cuff measurements have now become available. This study therefore evaluates the value of~     non-invasively measured arterial stiffness and central hemodynamics for guiding~     antihypertensive treatment in selected patient populations (i.e. elderly patients, patients~     with diabetes mellitus, patients with heart failure, and patients with resistant~     hypertension).~   "
93162|NCT01837771|"~     The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by~     interventionally placed electrodes may improve heart function, symptoms and functional~     capacity in patients with severe heart failure.~   "
93163|NCT01837758|"~     Aim of the study is a description of changes in platelet function during continuous~     veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the~     Multiplate system.~   "
93168|NCT01837693|"~     In industrialized countries, cervical cancer is a well controlled disease thanks to the~     diffusion of Pap test and, in particular, to organized screening programs, which are able to~     detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human~     papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of~     cervical cancer, so a new screening test based on the identification of high risk (HR) HPV~     types has been developed(HPV DNA test). This test has demonstrated to be more effective than~     cytology in reducing the incidence and the mortality of cervical cancer, but it is less~     specific, so the use of a test triage is necessary to reduce the number of colposcopies and~     the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions).~     Until now, the triage test used is the cytology (Pap test).~      Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN,~     targeting the molecular alterations strictly associated to transformation rather than simply~     detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest~     reduction of sensitivity for high-grade lesions.~      This is a multicenter randomised trial nested into some Italian screening programs based on~     the use of HPV DNA test as primary test.~      All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16.~     Women with positive cytology will be referred to colposcopy, while women with negative~     cytology will be randomized into two arms.~      This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as~     a primary screening test with direct sending in colposcopy.~      In particular the main objectives are:~        -  Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA~          positive test and mRNA or p16 negative.~        -  Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of~          DNA, with direct sending in colposcopy~        -  Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or~          p16 compared to the direct sending in colposcopy in women with HPV DNA test positive.~      Secondary objectives are:~        -  to assess the feasibility of mRNA testing in primary screening~        -  to validate the sample techniques for the new tests~        -  to standardize quality controls for the the new tests~   "
93169|NCT01837680|"~     The aim of this study is to compare glycemic control in pregnant women treated with insulin~     Detemir and pregnant women treated with NPH insulin. These women are diagnosed with~     gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type~     2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference~     between these two treatment modalities in terms of glycemic control in diabetes.~   "
93170|NCT01837667|"~     The purpose of this study is to test the safety of an investigational drug called LB-100 for~     Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a~     small molecule that in laboratory and animal studies has shown activity when used by itself~     or together with drugs approved to treat some types of cancer (chemotherapeutic agents).~     Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of~     the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will~     receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and~     docetaxel. This is the first study where LB-100 for Injection will be used in humans.~   "
93171|NCT01837654|"~     The purpose of this study is to find out whether plantarflexion has an effect on the degree~     of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in~     patients with detrusor overactivity (DO).~   "
93172|NCT01837641|"~     The study will evaluate the safety of LY3002813 by looking at adverse events. The study will~     also look at the effect the body has on LY3002813. Study participants will be healthy or~     will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to~     moderate AD.~      There will be seven groups of study participants. Five groups will receive a single dose of~     LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo~     given as an injection into a vein. Approximately 12 weeks will pass between the single dose~     and the first multiple dose. One group of participants will receive a single dose of~     LY3002813 given as an injection under the skin. One group of participants will receive a~     single dose of LY3002813 given as an injection into a vein.~   "
93173|NCT01837628|"~     Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing~     urethral pain during urodynamic test.~   "
93174|NCT01837615|"~     Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases~     that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in~     particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and~     ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in~     treating IBD and the Photopill capsule was developed for this purpose.~      An open-label, interventional, clinical trial was designed for assessment of the safety and~     feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative~     Proctitis.~      Primary endpoints being: safety reflected by the number and severity of adverse events and~     mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.~      Furthermore clinical and biochemical parameters are monitored during the study.~   "
93175|NCT01837602|"~     An open-label, clinical trial of autologous cMet redirected T cells administered~     intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be~     enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer~     refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with~     operable triple negative breast cancer.~   "
93176|NCT01837589|"~     The purpose of this study is to conduct a comparative study for the study of bone~     mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the~     reference technique, Dual-emission X-ray absorptiometry (DXA).~   "
93177|NCT01837576|"~     The purpose of this study is to evaluate the antipsoriatic effect of 5 different~     combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in~     compared to Daivobet® gel in order to explore/find other safe and effective combination of~     the two components.~   "
93178|NCT01837563|"~     The purpose of this study is to determine whether four new alternative imaging methods can~     be used to follow the response of breast cancer to the treatment patients are being given.~     These methods produce an image of the inside of the breast so that doctors can better decide~     whether breast cancer is responding to therapy. An important part of the study is to examine~     the same person with all methods in order to directly compare results. The four methods are:~     MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated~     EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy~     (abbreviated NIR). In addition to the experimental imaging methods, patients may also~     undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers~     compare the experimental methods. These additional examinations are accepted diagnostic~     procedures; they are not experimental. Some participants will have one or both of these~     additional examinations if clinically indicated.~   "
93179|NCT01837550|"~     The purpose of this study is to examine the short-term effects of complementing an~     educational program for hearing aid users with Internet support.~   "
93181|NCT01837524|"~     Randomized trial of grocery-store based nutrition counseling visits for weight management~     vs. in-office visits. The investigators will test pre- and post-intervention~     individual-level dietary quality, knowledge, self-efficacy around dietary choice, and cost~     of shopping, measuring difference between intervention and control arms. At the study's end,~     the investigators will also conduct focus groups with a subset of 20 patients (10 from each~     arm) and do a structured interview with the dietitian to better understand the feasibility,~     strengths and shortcomings of this approach. Patients who complete the main portion of the~     trial will be randomly selected for recruitment into a focus group and consented separately~     for that focus group at the end of the study.~      The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper~     visits will result in higher member diet quality scores, better nutritional knowledge~     scores, higher self-efficacy and confidence around food purchasing decisions, and more~     favorable perception of the visit by both dietician and member. The KP Personal Shopper~     approach may also result in increased grocery store costs for some members. Long-term, the~     investigators hypothesize that improvements in member perception, knowledge and dietary~     quality will lead to improved health outcomes.~   "
93182|NCT01837511|"~     This study aims to investigate the expression of Melanoma-associated antigen 3 (MAGE-A3),~     Melanoma-associated antigen C2 (MAGE-C2), New York esophageal squamous cell carcinoma 1~     (NY-ESO-1), L antigen family member 1 (LAGE-1), Wilms' tumor gene (WT1) and PRAME~     (PReferentially expressed Antigen of MElanoma) tumor antigens in a large number of~     pathologically proven stage I, II and III NSCLC samples of Asiatic patients.~   "
93183|NCT01837498|"~     The majority of patients undergoing surgery receive neuromuscular blocking agents (NMBAs) in~     the operating room. Reversal of neuromuscular blockade at the conclusion of a general~     anesthetic is accomplished with cholinesterase inhibitors (primarily neostigmine). Although~     these drugs are often effective in enhancing recovery of muscle strength, the onset of~     effect is often slow (usually 15-30 minutes). More effective neuromuscular reversal agents~     are needed in clinical practice to enhance surgical and anesthetic management of~     perioperative patients. A new reversal agent (sugammadex) will likely be approved for~     clinical use in the United States next year. Unlike neostigmine, sugammadex is effective in~     providing rapid antagonism of all levels of neuromuscular blockade (typically within 2-4~     minutes). The aim of this prospective observational study is to study neuromuscular and~     clinical recovery in 120 consecutive thoracic surgical patients receiving neostigmine,~     followed by a 120 consecutive thoracic surgical patients administered sugammadex (after the~     drug is approved by the FDA). In addition, after data on 120 patients reversed with~     neostigmine is collected, the data will be analyzed to compare patients with residual block~     (train-of four < 0.9) and without residual block (TOF </= 0.9)~   "
93184|NCT01837485|"~     Some evidences have shown that probiotics are effective in the treatment of irritable bowel~     syndrome. Because few evidences are available in our population, we investigated if~     probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol~     which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.~   "
93185|NCT01837472|"~     Evidence have shown benefits of gut flora modulation in treatment of irritable bowel~     syndrome (IBS), but few reports are available on the effects of multistrain probiotics and~     there are few reports available in this regard from our society. Thus, we investigated if~     probiotics are effective in our patients as well. We hypothesize that the multistrain~     probiotic Balance containing seven bacteria species including Lactobacillus strains,~     Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable~     bowel syndrome.~   "
93186|NCT01837459|"~     In this research study the investigators want to learn more about the risk of developing~     blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that~     results from blocking of the throat during sleep. This study examines changes in blood~     pressure, blood vessel stiffness, heart size and levels of specific substances in the blood~     which may cause heart disease.~      This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months.~     The first and last visits include an overnight sleep study (polysomnography or PSG). All the~     visits will include:~        -  body measurements to measure growth and how weight is distributed,~        -  resting blood pressure measurements,~        -  heart measurements (electrocardiogram and ultrasounds of the heart and blood vessels),~        -  36 hour home ambulatory blood pressure measurements,~        -  blood tests to look at things like fats, cholesterol, inflammatory factors,~        -  questionnaires~      Optional parts of the study include DNA and for children 8 years and older, testing and~     questionnaires to learn more about how sleep relates to learning, memory and behavior~     issues.~   "
93187|NCT01837446|"~     Oral mucositis is a debilitating side effects of cancer treatment for which there is not~     much successful treatments at yet. The investigators are going to evaluate the effectiveness~     of topical morphine compared with a routine mouthwash in managing cancer treatment-induced~     mucositis. The investigators hypothesize that topical morphine is more effective and more~     satisfied by patients than the magic mouthwash in reducing severity of cancer~     treatment-induced oral mucositis.~   "
93188|NCT01837433|"~     Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute~     Thyroiditis~      The investigators hypothesize that less adverse reactions will be observed, comparing with~     the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and~     permanent hypothyroidism aren't significant difference.~   "
93189|NCT01837420|"~     This study will examine the safety and efficacy in subjects with moderate to severe~     psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA),~     Dermatology Life Quality Index (DLQI) and other assessments.~   "
93190|NCT01837407|"~     Complex digital injuries involving soft tissue loss and digital nerve defect pose~     challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve~     pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital~     neurocutaneous defect of the proximal phalanx.~   "
93210|NCT01837134|"~     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching~     have the potential to support lifestyle change and weight loss. Therefore, the aim of our~     randomized controlled trial is to examine the effect of telemedicine with and without~     coaching in comparison to a control group on weight loss in overweight participants.~   "
93191|NCT01837394|"~     In this study, we wish to investigate the effect of ultrasound (US) -guided block of the~     saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative~     pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following~     ambulatory knee arthroscopy.~      We wish to investigate the analgesic effect of these two blocks compared to placebo~     (injection of local anesthetic with known pain blocking properties compared with injection~     of a saline solution), when used as a supplement to conventional oral analgesics.~      We hypothesize that patients receiving the active treatment may experience less pain during~     the first 24 hours after their operation than patients receiving the placebo treatment, and~     possibly require less opioid analgesics, experience less opioid related side effects and~     have a higher function level in this period than patients receiving the placebo treatment.~   "
93192|NCT01837381|"~     The objective of this trial was to evaluate the clinical outcome, treatment toxicity and~     tumor response of TEA for unresectable HCC.~   "
93193|NCT01837368|"~     Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment~     of quality of life and suffering in patients with tinnitus.~      Association between experiencing, verbalizing and regulating emotions and perceived~     tinnitus.~      Correlation analysis are used to search for connections between the subjective behavioral~     outcomes mentioned above and the objective EEG-patterns.~   "
93194|NCT01837355|"~     Pulmonary inflammation is an independent risk factor for disease progression in cystic~     fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental~     inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several~     inflammatory diseases. As children with CF have different faecal microbiota from their~     healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation~     might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy~     control) will receive either placebo or lactobacillus rhamnosus once daily as dietary~     supplementation for 12 weeks. After a one-week washout phase, they will be switched for~     another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation~     as well as clinical outcome will be studied.~   "
93195|NCT01837342|"~     Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A~     person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and~     infection sets in around the diverticulum the condition is called diverticulitis. An~     individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and~     fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent~     hospitalisations as a result of the evolution of purulent peritonitis that originates from~     diverticulitis treated by mini-invasive surgery results.~      Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic~     generalized purulent peritonitis of diverticular origin have been identified as therapeutic~     options by HAS (French health authorities), followed by second stage resection-anastomosis~     under elective surgery. It has been observed in patients that if only drainage and washing~     are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are~     much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore~     this reduces the risks of postoperatory complications.~      Some studies have shown that the attitude of non-distance resection of the acute episode was~     associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity.~     In addition, the morbidity associated with intervention sigmoid resection is around 30%.~      The question arises in our daily practice, or not to propose systematic resection of sigmoid~     diverticulitis after an acute episode of severe purulent peritonitis or abscess types~     supported initially by minimally invasive.~      The primary objective of the study is to determine, after clinical improvement linked to~     conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if~     a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as~     currently recommended.~      The secondary objective of the study is to determine if conservative treatment reduces~     mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and~     improves quality of life.~   "
93196|NCT01837329|"~     The main objective of this study is to determine recommended phase II dose and safety of~     tetrathiomolybdate (TM) in combination with carboplatin and pemetrexed in chemo-naive~     metastatic or recurrent non-squamous non-small cell lung cancer.~   "
93197|NCT01837316|"~     The study will be a randomized, double-blind, placebo controlled cross-over study in 32~     adult subjects with moderately severe asthma. In this study the bronchodilator effect of a~     single morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry.~     After the screening the subject will be randomized and will be assigned to one of two~     treatment sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the~     two treatment periods there will be a washout period of 7-14 days. A serial forced~     expiratory volume in one second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2,~     4, 12, 24, 36, 48, 60 and 72 hours post dose. Safety assessments will include vital signs,~     electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests~     however, these will not constitute study endpoints. The results of the study will provide~     supporting information to prescribers on the bronchodilator effect of FF/VI over 72 hours.~   "
93198|NCT01837303|"~     Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and~     standard Thin prep cytology screening.~      Participants: 100-120 healthy women presenting for standard pap smear screening~      Procedures (methods): After routine care pap smear, another pap smear will be performed and~     placed in the study medium. Clinical care pap and study pap will be reviewed by a single~     pathologist to assess for equivalent findings.~      Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based~     cytology.~   "
93199|NCT01837290|"~     Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to~     osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an~     increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be~     required for geriatric patients with end stage renal disease. These patients have severe~     comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the~     perioperative period. For this reasons a careful anesthesia plan should be planned and~     performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with~     chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine~     position with a fracture table. Intraoperative sedation might be necessary for patients~     under regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist~     that is being used as an agent for its sedative and adjuvant analgesic effects.~      The aim of this study is to evaluate the effects of dexmedetomidine premedication on~     geriatric patients with end stage renal disease, who will be undergoing a surgical operation~     for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral~     Index) guided sedation with intraoperative propofol infusion.~   "
93211|NCT01837121|"~     The purpose of this study is to use a randomized controlled design to determine the impact~     of a SMS messaging intervention on the following outcomes among persons diagnosed with~     diabetic retinopathy in rural China.~   "
93200|NCT01837277|"~     The current available antiretroviral (ARV) agents make possible a successful treatment of~     virtually all HIV-infected patients, but some problems related to early mortality are still~     of concern, mainly in resources-limited settings. There are several published reports~     showing that such patients are at a significantly higher risk of death during the first~     months of treatment, in comparison with the observed outcomes in developed countries. One of~     the consistently detected risks for early mortality across these reports is the baseline low~     CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and~     other developing countries, there is still a large proportion of AIDS patients who are~     diagnosed with AIDS, or only seek health care for HIV infection late in the course of~     disease. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV~     drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia,~     and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm.~     The investigators propose to compare the impact of RAL versus EFV in the early mortality~     rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.~   "
93201|NCT01837264|"~     Compartment syndrome (CS) is a condition resulting from increased pressure within a~     compartment, which compromises circulation and can lead to critical limb ischemia. CS is one~     of the biggest medical challenges that our soldiers face after battlefield related injuries.~     Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute~     compartment syndrome is a medical emergency requiring surgery. Treatment of compartment~     syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to~     evaluate the feasibility and safety of the administration of marrow-derived autologous bone~     marrow concentrate and PRP gel generated by a point of care marrow separation system for the~     treatment of compartment syndrome. And to show this treatment possibly enhances wound~     healing, bone healing, perfusion, infection control, and the return of limb function in~     patients with CS.~      Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and~     wound healing have predominantly focused on the mechanism of action of a single stem cell~     population to achieve neovascularization and improve tissue perfusion. It is well documented~     that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF,~     bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's~     development efforts focus on concentration of autologous bone marrow-derived stem cells and~     platelets for delivery to the site of injury in a concentration sufficient to effect local~     tissue revascularization and repair. These products provide for the rapid, bedside~     preparation of autologous PRP and bone marrow stem cell concentrate.~      This clinical trial with the Magellan® System is for the preparation of autologous cell~     concentrate for the treatment of wound, tissue and bone healing, improved perfusion,~     infection control, and the return of limb function in patients at risk of amputation.~   "
93202|NCT01837251|"~     Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer~     when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and~     PLD/carboplatin.~   "
93203|NCT01837238|"~     The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy~     beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones,~     arteries and heart in hemodialysis patients.~   "
93204|NCT01837225|"~     Breast cancer is the most commonly occurring cancer in women. Currently, breast conservation~     surgery (BCS) is the treatment most often prescribed. BCS involves removing the tumor while~     conserving the greatest amount of healthy breast tissue. Under standard white light, tumor~     borders are difficult for the surgeons to visualize. Therefore, between 30-70% of patients~     require a second operation to remove remaining cancerous tissue that wasn't detected during~     the initial surgery. Thus, there is an urgent clinical need for a new imaging tool that~     improves tumor visualization during the first surgery.~      PRODIGI, a new hand-held optical imaging device, uses a safe violet-blue light to detect~     fluorescence signals in the tissue. Different tissues are associated with specific~     fluorescent colors and therefore the device can be used to differentiate between tumor and~     healthy breast tissue. Based on previous clinical data, PRODIGI can distinguish some tumors~     from normal tissues, but is not specific enough to detect a difference across all breast~     tumor types.~      The fluorescent contrast drug 5-aminolevulinic acid (5-ALA) accumulates in tumors naturally~     and previous research has shown that 5-ALA increases tumor-normal tissue fluorescence~     contrast. In this observational clinical study, PRODIGI and 5-ALA will be used to visualize~     tumor borders during BCS. 5-ALA induced fluorescent images from the surgical sample and the~     surgical bed obtained by PRODIGI will be compared retrospectively with the images taken~     under standard white light and/or autofluorescence. The technology's ability to accurately~     identify tumor borders better than conventional practice will be confirmed by tissue~     pathology.~   "
93205|NCT01837199|"~     Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX)~     and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and~     microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with~     ChP. However, the effects of this antibiotic protocol have not been directly compared in~     non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical~     and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and~     non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers~     would benefit better from this combination of therapies than the smokers.~   "
93206|NCT01837186|"~     Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem~     that occurs in about 2% of pneumonectomy patients.~   "
93207|NCT01837173|"~     It is well known that lymph node metastasis is one of the most important prognostic factors~     in oesophageal carcinoma.~      The investigators want to determine the influence of lymph node characteristics, being~     either intracapsular or extracapsular, on overall survival after esophagectomy for~     esophageal cancer.~   "
93208|NCT01837160|"~     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible~     for cardiovascular disease. In this proposal, the investigators intend to build upon a~     highly successful programme of studies exploring the cardiovascular applications of positron~     emission tomography. Specifically, the investigators will explore the potential role of a~     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and~     αvβ5 integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and~     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic~     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here~     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,~     specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate~     18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex~     vivo histological characterisation of tissue. If successful, this novel radiotracer could~     provide an extremely important non-invasive method of assessing in vivo angiogenesis, plaque~     vulnerability, and tissue remodelling as well as potential applications in developing stem~     cell therapies.~   "
93212|NCT01837108|"~     Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR)~     antagonists in the setting of an acute myocardial infarction. In a recent animal study, the~     protective effect of MR antagonists on infarct size was completely abolished in CD73~     knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine~     receptor antagonists in rats. These findings suggest that extracellular formation of~     adenosine is crucial for this protective effect and that MR antagonists stimulate~     extracellular adenosine formation by the enzyme CD73.~      To investigate whether eplerenone promotes adenosine receptor stimulation by activating~     CD73, the investigators will measure forearm blood flow in response to various dosages of~     dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular~     endogenous adenosine concentration by inhibition of the ENT transporter and induces local~     vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects~     extracellular adenosine formation by the CD73 enzyme.~   "
93213|NCT01837095|"~     POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to,~     on the day of and on days after treatment with eribulin. Different doses and dosing~     frequencies will be investigated~   "
93214|NCT01837082|"~     The hypothesis to be tested is whether treatment with intravenous iron (ferric~     carboxymaltose) will improve left-ventricular ejection fraction in patients with heart~     failure and iron deficiency as determined by cardiac magnetic resonance imaging.~   "
93215|NCT01837069|"~     This trial is designed to determine the best preoperative management strategy for patients~     undergoing orthopedic surgery.~   "
93216|NCT01837056|"~     Investigate the prevalence of Toxoplasma gondii and Toxocara canis in Uveitis~        -  serum antibody to T. gondii and T. canis~        -  PCR with peripheral blood for T. gondii and T. canis~        -  PCR with aqueous humor for T. gondii and T. canis~        -  Clinical manifestation of patient with uveitis~   "
93217|NCT01837043|"~     The purpose of this study is to evaluate the safety and efficacy of conversion from a~     calcineurin inhibitor (tacrolimus or cyclosporine) immunosuppression therapy to Nulojix®~     (belatacept) immunosuppression therapy in patients with delayed (DGF) or slow graft function~     (SGF) following kidney transplantation. Patients at risk for SGF or DGF will be consented at~     the time of kidney transplantation. On post-op Day 5 the patient will be assessed, if they~     have developed SGF or DGF they will be randomized to convert to Belatacept or continue on~     their CNI regimen. Up to 20 subjects who do not develop DGF will be followed as control~     subjects. Seventy randomized subjects will be followed for a total of 14 months with a renal~     biopsy at Month 12 post transplant.~      Research Hypotheses:~      Primary Hypotheses:~        -  Kidneys with slow or delayed graft function are more susceptible to acute and long-term~          CNI toxicity~        -  Kidneys converted from calcineurin inhibitor based therapy to belatacept will achieve a~          more rapid recovery from post-ischemic acute tubular necrosis (ATN) and will have~          improved 1 year calculated GFR.~      Key Secondary Hypotheses:~        -  Renal Histology: Belatacept converted patients will have a lower chronic allograft~          damage index (CADI) score and lower interstitial fibrosis and tubular atrophy (IF/TA)~          score as calculated by Banff criteria at 1 year post- transplant~        -  Biomarker Analysis: Biomarker analysis (clusterin) measured in serial urine collections~          can 1) directly assess CNI induced kidney injury and 2) improve the prediction of~          patients that benefit in early belatacept conversion.~   "
93218|NCT01837030|"~     This study is a single center prospective randomized control trial comparing the utility of~     performing capsule endoscopy compared to conservative management with oral iron therapy as~     the initial course of action in patients with non-severe obscure occult or obscure overt~     gastrointestinal (GI) bleeding. The investigators hypothesize that outcomes in patients with~     non-severe obscure GI bleeding who receive conservative therapy with oral iron will not~     differ to those on oral iron who undergo capsule endoscopy.~   "
93219|NCT01837017|"~     Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and a~     majority of those who fall require medical attention for injuries. Importantly, balance~     dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among~     community-dwelling older adults and likely persons with MS. Indeed, there is evidence that~     these physiological risk factors can be minimized with exercise training in persons with MS~     and this might translate into a decrease in fall risk as documented in community-dwelling~     older adults.~      The investigation will examine the effectiveness of a home-based exercise program that is~     designed to reduce fall risk by targeting specific fall risk factors including balance~     dysfunction and two of its latent causes, muscle weakness and spasticity in persons with~     multiple sclerosis. It is predicted that persons who receive home-based exercise program~     will have a reduction in fall risk.~   "
93220|NCT01837004|"~     The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise),~     a multi-faceted, general and exercise-specific cognitive training program plus a 4-month~     exercise program, to an attention-control condition involving health and wellness~     informational lectures plus videos. The proposed exercise program will involve both aerobic~     and resistive exercises. The investigators hypothesize that pre-intervention cognitive~     training will enhance self-regulation and self-efficacy and in turn, increase exercise~     adherence. The investigators also expect more positive improvements in cognitive and~     psychosocial function among participants in the CORTEX condition as compared to the Control~     condition immediately following the cognitive booster training, and across time.~   "
93221|NCT01836991|"~     The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical~     surgery for the treatment of advanced distal gastric cancer.~   "
93222|NCT01836978|"~     The process of enhancing the functional capacity of an individual before an operation to~     enable him or her to withstand the stress of surgery has been termed prehabilitation. It has~     been shown that poor baseline capacity for physical performance and poor nutritional status~     increase the risk of complications after major non cardiac surgery and prolong recovery. A~     controlled randomized study in patients undergoing radical cystectomy for cancer is~     therefore proposed to determine the impact of multimodal prehabilitation on functional~     exercise capacity and functional recovery. Patients who accept to be enrolled in the study~     will be randomized to either a group receiving a multimodal intervention which includes~     nutritional supplementation (Immunocal® whey protein) combined with a physical exercise~     program and stress reduction strategies before and after surgery, or a control group who~     will receive standard preoperative treatment as per our institution.~   "
93223|NCT01836965|"~     The objective of this study is to validate a social skills training program manual for~     adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately~     150 adolescents with autism spectrum disorders will participate in this study, in groups~     consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both~     group therapy and peer generalization sessions (in the form of a photography class) once a~     week over the course of twelve weeks. Participants and their parents will complete paper and~     pencil, online, or phone measures and video-recordings to assess the participant's social~     skills prior to the intervention, at completion of the intervention and three months later.~   "
93224|NCT01836952|"~     Dietary and oral hygiene habits are known to affect oral microorganisms and disease~     incidence, but most research has focused on preschool aged (2-4 yr old) children. A recent~     experiment in our lab demonstrated a highly diverse oral microbiome in the saliva of infants~     without teeth (3-6 months old). These data suggest that soft tissues in the mouth serve as a~     reservoir for pathogens and must be considered in oral health management. The evolution of~     microorganisms that occurs between birth and tooth eruption has not been characterized and~     may have great implications as it pertains to oral disease later in life. The investigators~     are interested in determining how dietary changes during this time affect oral microbiota.~     Tongue and cheek swab samples will be collected from a small cohort of infants (n=20) at 4~     time points. At the same time, a survey and 3 day feeding diary of the infant's diet will be~     collected. In addition, a pregnancy survey and food frequency questionnaire will be~     administered at the time of recruitment. Research staff will conduct a 10-minute interview~     at the first and last oral sample collection time. These pilot data will provide important~     diet-oral microbe relationships in edentulous infants, allowing us to propose and test~     specific hypotheses pertaining to diet, oral microbes, and disease in young children.~   "
93225|NCT01836939|"~     The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris~     suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.~   "
93226|NCT01836926|"~     The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing~     procedures. Intersphincteric resection is procedure to treat very low rectal cancer within 2~     cm from the dentate line to avoid permanent colostomy,improves the quality of life with~     better genitourinary function. Neoadjuvant chemo-radiotherapy is routine for T3 cases.~   "
93227|NCT01836913|"~     The RESPECT study is intended to prospectively assess the impact of PET/CT on the~     delineation of target volumes and to estimate the proportion of recurrences that could~     possibly be prevented by the use of PET/CT-based target volume, instead of CT-based.~     Patients will recieve radiotherapy using CT-based planning, but a PET/CT-based treatment~     plan will also be made. CT-based and PET/CT-based target volumes will be compared after~     treatment has been completed. If a locoregional recurrence takes place, the localisation~     will be compared to the CT-based and PET/CT based clinical target volumes (CTVs). If the~     local recurrence is located outside the CT-CTV but inside the PET/CT-CTV, the recurrence~     could possibly have been prevented with PET/CT-based radiotherapy.~   "
93228|NCT01836900|"~     Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers~     are randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or~     endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to~     standard therapy regarding technical success and rebleeding.~   "
93229|NCT01836887|"~     The purpose of this study is to determine whether consumption of the active product affects~     postprandial changes in metabolic indices, in comparison to the control product.~   "
93230|NCT01836874|"~     The purpose of this study is to evaluate the safety and effectiveness of topiramate in~     preventing migraine among Indian participants requiring prophylaxis (measure taken to~     maintain health and prevent the spread of disease).~   "
93231|NCT01836861|"~     This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME)~     and absolute bioavailability study in 6 healthy adult male subjects.~   "
93232|NCT01836848|"~     The purpose of this study is to show if it is possible to detect secondary ischemic events~     in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive~     near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral~     perfusion.~   "
93233|NCT01836835|"~     Nausea in early pregnancy (emesis gravidarum) is very common but most often self-limiting.~     Hyperemesis gravidarum; where nausea and vomiting is severe and protracted is potentially~     dangerous for the woman and her foetus and necessitates hospital treatment. An English~     questionnaire (PUQE; Pregnancy Unique Questionnaire of Emesis) exists that can differentiate~     between uncomplicated emesis and the severe hyperemesis condition. This questionnaire has~     been translated to Norwegian. The investigators want to test the ability of this~     questionnaire to differentiate the grade of nausea/vomiting between a group of presumed~     normal pregnant woman and patients treated for hyperemesis gravidarum in a Norwegian~     population. The investigators also want to relate the PUQE questionnaire scoring to the~     women/patients' self-reported nutritional intake during 24 hours.~   "
93234|NCT01836822|"~     The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle~     aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal~     lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are~     considered insufficient and histological sampling is preferred. The aim of the study is to~     compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to~     obtain histological samples from MLN in patients with clinical and radiological features of~     sarcoidosis.~      Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial~     forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps~     biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement~     and clinical and radiological features of sarcoidosis.~      Diagnostic accuracy of each sampling technique will be calculated and compared to other~     techniques. Diagnostic yield of different technique combinations will also be calculated and~     the most efficient diagnostic approach will be defined.~   "
93267|NCT01836393|"~     To determine whether plai cream is effective in treating mild to moderate degrees of~     osteoarthritis of the knee in the elderly patient compared with placebo cream.~   "
93235|NCT01836809|"~     The prevalence of renal dysfunction after implantation of the artificial heart is high. The~     infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total~     artificial heart (TAH) improves renal function in a sustained manner. The renal protective~     and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared~     to heart failure surgery that leaves the native myocardium intact. The goal of this project~     is to determine the renal protective effects of nesiritide after implantation of a~     mechanical device.~   "
93236|NCT01836796|"~     Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut~     microbiota) can function as an environmental factor that modulates the amount of body fat.~     Obese individuals have an altered gut microbiota and germ-free mice are resistant to~     developing diet-induced obesity and have lower fasting insulin and glucose concentrations~     and shows an improved glucose tolerance. Administration of the probiotic bacterium~     Lactobacillus Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body~     weight in obese adults possibly by reducing lipid absorption and inflammatory status.~     However, there are no controlled studies to the investigators knowledge that address whether~     probiotic supplementation affects glucose metabolism. The investigators hypothesis is that~     supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2~     diabetes patients. In addition, the investigators will explore possible mechanisms behind~     the antihyperglycemic action of Lactobacillus Reuteri.~   "
93237|NCT01836783|"~     The study will compare the density and strength of regenerated bone in extraction sockets~     after being grafted with two different materials: Bone Allograft and Bone Allograft with~     Amnion.~      The investigators hypothesize that sockets grafted with the Amnion graft will exhibit~     enhanced healing patterns and will accelerate the formation of regenerated bone in the~     grafted areas.~   "
93238|NCT01836770|"~     The purpose of this study is to describe the contrast flow patterns in the epidural space~     using the inferior-anterior approach with continuous fluoroscopic guidance, and determine~     how well this approach correlates with appropriate contrast flow patterns and with analgesia~     at follow up. This knowledge may prove useful in guiding physician practice patterns in the~     non-surgical management of low back pain.~      Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior)~     epidural contrast spread based on inferior-anterior needle-tip position, particularly with~     appropriate needle tip position.~   "
93239|NCT01836757|"~     To delineate the effect of MSM on osteoarthritis~   "
93240|NCT01836744|"~     Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous~     bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to~     3 implants in each side and analyse the survival rate and possibles differences related to;~     prosthesis failure; biological and prosthetic complications; peri-implant marginal bone~     level changes.~   "
93241|NCT01836731|"~     Community Health Clubs to improve local sanitation, hygiene and health conditions have been~     implemented in several countries in Africa and Asia with some success. The Ministry of~     Health in Rwanda has committed to rolling out a program designed along similar lines, the~     Community Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages~     across Rwanda. The main objective of the program is to achieve 'zero open defecation' in all~     villages of Rwanda, at least 80% hygienic latrine coverage and improvements in a range of~     health behaviors such as the use of mosquito nets, hand-washing with soap and the use of~     household water treatment.~      To evaluate the impact of the program on health, other socio-economic outcomes and community~     functioning, a single district has been chosen where 150 communities will be randomized to~     receive the intervention immediately or 18 months later. The evaluation is led by US based~     Innovation for Poverty Action (IPA) through researchers based at the National University of~     Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York~     University. The research team will work in close collaboration with the implementing team,~     which consists of the Ministry of Health, Rwanda and Africa AHEAD.~      The study will span three years, beginning in May 2013, and ending in late 2015.~   "
93242|NCT01836718|"~     The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver~     transplantation in patients receiving antiviral therapy while on the liver transplant~     waiting list. This will eventually be correlated with the degree of hepatic fibrosis present~     within different geographic sites in the cirrhotic liver. Tissue samples will be obtained~     from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the~     cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times~     in different segments of the liver and preserved for viral detection studies as well as~     analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be~     obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also~     be obtained at 1 month, 3 months and 6 months post liver transplantation.~      Study Hypotheses:~        -  Virological relapse or non-response is higher is patients with cirrhosis due to failure~          of antiviral medication to concentrate adequately in a fibrotic liver having an altered~          sinusoidal micro-architecture~        -  HCV may persist in different geographic regions of the fibrotic liver in part~          predicated on blood supply to that area and this may have an effect on overall~          virological response. These differences in viral persistence and detection may exist in~          different lobes of the liver or even within a few centimeters within the same portion~          of the liver parenchyma.~        -  PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in~          patients receiving antiviral therapy and may account for virological relapse~          post-therapy~        -  There may be varying degrees of fibrosis within the same cirrhotic liver which may~          impact on hepatic synthetic function and antiviral response to treatment.~   "
93243|NCT01836705|"~     Primary Objective:~      - To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the~     QTcF interval compared to 1-day placebo in patients with advanced solid tumors.~      Secondary Objectives:~        -  To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate~          (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.~        -  To assess the clinical and laboratory safety of SAR302503~        -  To document the plasma concentrations of SAR302503 at the time of ECG investigation.~        -  To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503~          concentration and QTcF~        -  To explore antitumor activity~   "
93268|NCT01836380|"~     Hypothesis #1: The investigators hypothesize that both swimming training and cycling~     training will demonstrate significant improvements in endothelium-mediated vasodilation and~     central artery compliance in this population and that there will be no difference in the~     magnitude of increases between the water-based and land-based exercise interventions.~      Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent~     vasodilation and arterial compliance in response to exercise training interventions will be~     related to the corresponding reductions in inflammatory biomarkers.~      Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling~     exercise will improve functional capacities and disease progression in middle-aged and older~     adults with osteoarthritis.~   "
93244|NCT01836692|"~     This study is for patients having a course of chest radiotherapy treatment after receiving~     chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell~     lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.~      In this study, we will investigate:~        -  whether giving a more targeted and individualised type of chest irradiation or~          radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it~          causes side effects which can be tolerated~        -  whether this new method of delivering the radiotherapy can reduce the risk of the~          tumour in the lung recurring or progressing~        -  whether survival can be improved by using this new radiotherapy method~      The dose of chest irradiation will be calculated specifically to suit patient's body shape,~     the position of the lung cancer, and how close healthy tissues are to the tumour.~     Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration~     of treatment will vary individually according to the delivered dose to the tumour area.~   "
93245|NCT01836679|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with~     paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.~   "
93246|NCT01836666|"~     How are the health related quality of life among patients with chronic pain effected by~     interventional pain managment?~      Hypothesis:~      Health related quality of life can be improved by interventional pain management both among~     patients with localizable pain focuses and among patients among whom no pain focuses can be~     found.~      Method:~      Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the~     time of treatment for pain focuses an during the following 12 months.~   "
93247|NCT01836653|"~     The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and~     mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol~     1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.~   "
93248|NCT01836640|"~     There are three major subtypes of breast cancer:~        1. Hormone receptor positive (contain cells that express the estrogen receptor or~          progesterone receptor).~        2. Tumors that express the epidermal growth factor receptor gene ( HER-2)~        3. Triple negative (cancer cells that lack the hormone receptors and the epidermal growth~          factor receptor gene HER-2.~      While effective therapies exist for most cases of breast cancer at first occurrence, many~     patients eventually exhibit disease that does not respond to all standard breast therapies,~     particularly in the metastatic setting.~      There are therapies that are used to treat other types of cancers with genetic mutations~     that are in the process of being evaluated for use in breast cancer. The current techniques~     used for detecting mutations in the genes of breast cancer patients, which can be treated~     with drugs specific for the genetic mutations, are invasive and identifying effective~     diagnostic non-invasive procedures are the next challenge for physicians. This study will~     compare the ability to detect genetic mutations samples from non-invasive procedures such as~     a blood draw, to more invasive procedures such as tissue taken from a biopsy sample.~      There is also a concern with current techniques used to detect genetic mutations that cells~     from a single tissue sample may not be representative of the types of cells present in all~     the tumors in the body and therapies selected using a single tissue sample may not be~     effective for all of the cancer in the body. This study will use blood drawn from~     participants prior to any drug therapy and compare the genes from this blood to tissue~     samples from multiple sites of disease.~      The study will also compare the genetic profile of the metastatic tumors to the genetic~     profile of the original breast cancer to determine if there are any changes in the genetics~     of the tumor cells.~      The participants that have newly diagnosed metastatic disease will provide tissue from their~     primary site of disease via an image guided biopsy. These participants will also provide~     tissue from at least 2 other distant metastatic sites (lung, pleural/peritoneal, liver,~     brain, or skin). Each biopsy procedure will attempt to obtain 2-3 samples for research~     purposes.~      Participants that have locally recurrent disease in the breast will have the tissue from the~     site of re-occurrence biopsied as well as two distant metastatic sites (lung,~     pleural/peritoneal, liver, brain, or skin). Participants that have either multi-centric~     disease or bilateral disease will have all tumors sampled with the intention of providing~     2-3 samples/tumor for research purposes. Participants with multi-centric and bilateral~     disease will also have 2 distant sites of distant disease sampled (lung, pleural/peritoneal,~     liver, brain, or skin).~      Prior to any scheduled biopsy procedures all participants will have a blood draw used to~     examine the genetics of the tumor cells in the blood. The participants will have 8 tubes of~     blood drawn for the test and then they will proceed onto the tissue sampling portion of the~     study.~   "
93249|NCT01836627|"~     This research study includes children ages 5 to 20 years old with Collagen Type 6 Congenital~     Muscular Dystrophy or Laminin α2-related muscular dystrophy (LAMA2-MD). The goal of this~     study is to measure the effect of breathing exercise to stretch the chest in slowing the~     loss of breathing function. The breathing stretches are done with a machine called Cough~     Assist®.~      The study is being done at Cincinnati Children's Hospital Medical Center and Children's~     Hospital of Philadelphia. The study involves traveling to one of these 2 centers for 4~     visits over 13 months. The study also includes 3 sets of phone visits called Daily Phone~     Diaries.~      Participants will be randomized into one of 2 study groups in a 1:1 ratio. The treatment~     group will use the Cough Assist® machine twice a day for 15 minutes. The control group will~     continue with their current daily care. The Cough Assist® is a machine that blows air into~     the lungs (insufflation) and helps pull air out of the lungs. The investigators will be~     blowing enough air into the lungs to cause a stretch to the chest. This is called~     hyperinsufflation.~      Study visits will last about 5 to 6 hours and will include medical and quality of life~     questionnaires and pulmonary function tests to determine lung function and the~     individualized settings to be prescribed for the Cough Assist®.~   "
93250|NCT01836614|"~     The purpose of this study is to determine if an intravenous lidocaine infusion (compared to~     placebo) intraoperatively will decrease time to return of bowel function postoperatively,~     decrease postoperative pain, diminish postoperative opioid requirement, minimize~     inflammatory markers and shorten time to discharge after colorectal surgery.~   "
93251|NCT01836601|"~     This study seeks to determine whether a family-centered nighttime communication intervention~     improves: 1) shared understanding by parents, residents, and nurses of hospitalized~     pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider~     experience of nighttime medical care.~   "
93252|NCT01836588|"~     It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix~     will bring the same conclusion than the conventional cervix biopsy, but with less pain and~     morbidity, after patients were undergoing a conisation in order to treat CIN.~   "
93286|NCT01836133|"~     This multicenter, observational study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in patients with locally advanced or metastatic adenocarcinoma non-small cell~     lung cancer and an ECOG performance status of 0-1. Eligible patients receiving Tarceva~     according to the Summary of Product Characteristics and local label will be followed for the~     duration of their treatment.~   "
93287|NCT01836120|"~     A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in~     subjects with Gastric Cancer.The purpose of this study is to compare the activity of~     Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with~     gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.~   "
93397|NCT01834651|"~     This research study is being done to measure the clinical benefit associated with~     cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs~     (organs other than bone or lymph nodes) and no longer responds to initial hormonal~     (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant~     prostate cancer.~   "
93253|NCT01836575|"~     Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and~     underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients.~     Patient PS 2 proportion in population-based studies is considerably higher than that~     included in clinical trials. Management of patients with PS of 2 in clinical practice is~     empirical and inconsistent. Patients have median overall survival of 3 to 5 months in~     randomized trials, and treatment options include best supportive care, single-agent and~     combination chemotherapy. Retrospective studies have suggested that patients PS 2 may~     benefit from first-line chemotherapy in terms of symptom improvement and overall survival.~     In many of these studies, single-agent chemotherapy was compared with best supportive care~     alone. Data on the role of cisplatin-based combinations for patients with PS 2 is more~     scant, with one study questioning its benefit, and another interrupting accrual because of~     undue toxicity. With regards to carboplatin, the Cancer and Leukemia Group B (CALGB) study~     9730 compared paclitaxel plus carboplatin versus paclitaxel alone in a subgroup of 107~     patients with PS 2; the median overall survival was significantly longer in group treated~     with combination chemotherapy (4.7 versus 2.4 months). Combination chemotherapy with~     carboplatin and paclitaxel also produced a statistically significantly higher incidence of~     severe hematological and non-hematological toxicities. On the basis of aforementioned~     results, a recent European panel stated that carboplatin-based or low-dose cisplatin-based~     doublets might represent alternative options to single-agent chemoterapy in patients PS 2.~     Outside clinical trials, single-agent chemotherapy with a 3rd generation agent remains valid~     option for patients PS2. Results demonstrate that pemetrexed is an agent with established~     single-agent activity in NSCLC, and suggest it is a potential candidate for combinations~     with platinum and other agents currently utilized for patients with advanced NSCLC.~     Favorable toxicity profile of pemetrexed suggests that this agent is an ideal candidate for~     single agent testing and in combination among patients with PS 2. Substantial doubt remains~     in the comparative benefit from monotherapy versus combination. Starting dose and schedule~     of pemetrexed were set for this study based on its current labeling in the 2nd line~     treatment of metastatic NSCLC and 1st line treatment of malignant pleural mesothelioma.~   "
93254|NCT01836562|"~     This clinical trial is a single Arm, single centre to check the safety and efficacy of bone~     marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be~     conducted for 36 months.~   "
93255|NCT01836549|"~     This molecular biology and phase II trial studies how well imetelstat sodium works in~     treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
93256|NCT01836536|"~     Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an~     antiangiogenic treatment currently proposed to recurrent high grade glioma patients.~     Unfortunately some patients fail to respond to this treatment and finding biological factors~     allowing the discrimination between potential responders and non responders would be very~     helpful. As the immune system plays a key role in angiogenesis induction and maintenance in~     cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.~      The purpose of this study is to determine the influence of bevacizumab treatment on~     circulating immune cells in high grade glioma patients and to search for a link between the~     variation of these cells and the response to treatment.~   "
93257|NCT01836523|"~     This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety~     of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total~     trial duration per subject is approximately 58 weeks.~   "
93258|NCT01836510|"~     Multicentre study with the objective to correlate heart failure hospitalizations and deaths~     with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of~     Home Monitoring data with the greatest sensitivity and specificity in predicting Heart~     Failure events.~      All data are prospectively collected.~   "
93259|NCT01836497|"~     The study is designed to confirm safety and efficacy of the SD01 ICD (implantable~     cardioverter-defibrillator) lead.~   "
93260|NCT01836484|"~     This is a prospective diagnostic performance study which compares three new imaging methods~     with the current standard imaging method for the diagnosis of metastatic lymph nodes.~   "
93261|NCT01836471|"~     The purpose of the study is to assess the clinical effect of QAW039 in non-atopic asthmatics~     taking low dose Inhaled Corticosteroid (ICS) as background therapy.~   "
93262|NCT01836458|"~     This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male~     patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single~     dosing with KAE609~   "
93263|NCT01836445|"~     Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all~     young people in the U.S. and are alone in facing an increasing rate of infections. Because~     YMSM are less likely to receive relevant sexual health education in traditional settings~     (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.~      The purpose of this study is to compare two different versions of an online HIV prevention~     program for YMSM. The study is being conducted by researchers at Northwestern University in~     Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900~     YMSM will be enrolled into this study from the clinics of community partners in Chicago, New~     York, and Atlanta.~      Participants will be randomly assigned to one of two versions of the program. Some topics in~     the program include HIV facts and myths, sexually transmitted infections (STIs), and condom~     use. All participants, regardless of the program version they receive, will also take~     at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the~     program, participants will be contacted three more times over the course of a year for~     follow-up sessions and surveys.~      The research team hypothesizes that the YMSM-specific prevention program will lead to a~     significant reduction in the frequency of unprotected anal sex acts and new STI infections~     compared to the HIV knowledge program that is for a general audience. The YMSM-specific~     program will also lead to improvements in secondary knowledge, motivation, and skills~     outcomes.~      In order for the research team to measure the effectiveness of the YMSM-specific prevention~     program and determine if the study hypothesis is correct, participants will be asked~     questions about themselves, including questions about their sexual orientation, sexual~     experiences, health practices, including drug use, health knowledge, and questions about~     their feelings and emotions. Based on this information, the research team hopes to later~     change, improve, or expand the program to better address the needs of YMSM.~   "
93264|NCT01836432|"~     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most~     patients diagnosed with pancreatic cancer continue to die from the rapid progression of~     their disease. One primary reason for this is that the disease is typically without symptoms~     until significant local and/or distant spread has occurred and is often beyond the chance~     for cure at the time of the diagnosis. The lack of any treatment to substantially increase~     long term survival rates is reflected by the poor outcomes associated with this disease,~     specifically time to disease progression and overall survival.~      However, another important part of the body is now being looked at as a target for therapy~     against this disease - the immune system. Scientists have clearly shown that pancreatic~     tumor cells produce a number of defective proteins, or express normal proteins in highly~     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can~     cause an immune response to the cancer cells much in the way one responds to infected~     tissue. In progressive cancers however, the immune system fails to effectively identify or~     respond to these abnormalities and the cancer cells are not attacked or destroyed for~     reasons not yet fully understood. This clinical trial proposes a new way to stimulate the~     immune system to recognize pancreatic cancer cells and to stimulate an immune response that~     destroys or blocks the growth of the cancer.~      This new method of treatment helps the immune system of pancreatic cancer patients to~     identify the cancerous tissue so that it can be eliminated from the body. As an example,~     most people are aware that patients with certain diseases may require an organ transplant to~     replace a damaged kidney or heart. After receiving their transplant, these patients receive~     special drugs because they are at great danger of having an immune response that destroys or~     rejects the transplanted organ. This rejection occurs when their immune system responds~     to differences between the cells of the transplanted organ and their own immune system by~     attacking the foreign tissue in the same way as it would attack infected tissue. When the~     differences between foreign tissues and the patient's body are even larger, as with the~     differences between organs from different species, the rejection is very rapid, highly~     destructive, and the immunity it generates is longlasting. This is called hyperacute~     rejection and the medicine used to immunize patients in this protocol tries to harness this~     response to teach a patient's immune system to fight their pancreatic cancer just as the~     body would learn to reject a transplanted organ from an animal.~      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that~     contain a mouse gene that marks the cancer cells as foreign to patient's immune systems. The~     immune system therefore attacks these cancer cells just as they would attack any truly~     foreign tissue, destroying as much as it can. Additionally, the immune system is stimulated~     to identify differences (aside from the mouse gene) between these cancer cells and normal~     human tissue as foreign. This education of the immune system helps treat the patient~     because pancreatic cancer cells already present in a treated patient are believed to show~     some of the same differences from normal tissue as the modified pancreatic cancer cells in~     the product. Due to these similarities, the immune system, once educated by the~     Algenpantucel-L immunotherapy, identifies the patient's cancer as foreign and attacks.~      The chemotherapy combination to be used in this study has been shown to improve survival in~     advanced pancreatic cancer and is being combined with an experimental pancreatic cancer~     immunotherapy that stimulates the immune system to recognize and attack the cancer. One goal~     of this study is to determine whether chemotherapy and immunotherapies can work~     cooperatively to increase anti-tumor effects to levels beyond what would be seen with either~     treatment alone.~      In this experimental study, all patients are given a strong combination of anti-tumor~     chemotherapies while some patients are also given injections of an immunotherapy drug~     consisting of two types of pancreatic cancer cells that we have modified to make them more~     easily recognized and attacked by the immune system. We propose to test this new treatment~     protocol in patients with locally advanced pancreatic cancer to demonstrate that treatment~     with the immunotherapy increases the time until the tumor progresses or increases overall~     survival when given in combination with the current standard of care therapy for this~     disease.~   "
93265|NCT01836419|"~     There are some differences between elderly and young adult patients regarding the anatomy of~     upper airways. Elderly patients have larger upper airways than young adult patients at all~     pharyngeal levels as revealed by CT. Another study explained that there is a progressive~     descent of the larynx and epiglottis with aging, which lengthens the upper airway and~     possibly makes it more likely to collapse.~      The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in~     elderly patients with young adults. In this study, the investigators will measure the ease~     of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure,~     gastric leak pressure, fiberoptic position and intraoperative complications of the classic~     LMA.~   "
93266|NCT01836406|"~     Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with~     clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney.~     Interruption of renal blood flow via pedicle clamping is often necessary during partial~     nephrectomy, especially for complex tumors with deep parenchymal invasion.~     Ischemia-reperfusion injury is a complex process involving several mechanisms including~     renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators~     will examine the postoperative renal function of patients who received intraoperative~     ketorolac and remote ischemic preconditioning during partial nephrectomy.~   "
93269|NCT01836367|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for~     the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,~     topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for~     therapy, however as with other lesion-directed therapies, cryosurgery does not treat~     subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the~     sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been~     approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide~     an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel~     0.015% has shown to not only have a high clearance rate but also a transient localized~     inflammatory skin response that resolves quickly without sequelae. However, one common fear~     about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs~     and healthy skin, and that retreatment would produce an equally, if not more, caustic result~     on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this~     misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would~     result in lower LSR scores compared to the LSR in the first cycle of application. We plan to~     treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a~     25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of~     ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will~     be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days~     regimen for both cycles.~   "
93270|NCT01836354|"~     DESERVE is a discharge education study using health workers to enroll and randomly assign~     800 subjects diagnosed with TIA, or mild stroke to either risk factor education or usual~     care. Those patients assigned to education will receive stroke preparedness education plus~     risk factor reduction education, and help accessing follow up care with health workers.~     Those patients assigned to usual care will receive written stroke preparedness education.~     This protocol will evaluate the effectiveness of this intervention to reduce blood pressure,~     and individual stroke risk factors and future stroke risk.~   "
93271|NCT01836341|"~     The purpose of this Phase I study is to test the safety of combining afatinib with standard~     chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and~     radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This~     study will then test the safety of afatinib at different dose levels when combined with the~     chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given~     during radiation treatment and the drug afatinib will be continued after chemotherapy and~     radiation.~   "
93272|NCT01836328|"~     The majority of current studies regarding the use of methadone (MTD) in the treatment of~     cancer pain are focused in its administration via the oral route (PO). The ratio considered~     from VO to parenteral route (BP) is 2:1. Academic literature assumes the ratio from BP to VO~     to be 1:2. In our unit, we use MTD in the context of ROP and not as the last opioid. If face~     with a situation where there is a good control of pain with MTD BP, usually we move to VO.~     We have observed that the traditional ratio tend to produce certain toxicity problems.~     Because of this, we have proposed a new ratio of conversion from PAR MTD to oral MTD, i.e.~     1:1.2~   "
93273|NCT01836315|"~     Hypothesis: The investigators propose that obese parturients will have an increased~     inflammatory response and a decreased anti-inflammatory response to the surgical and~     anesthetic insult of caesarean section and that this will be associated with a higher rate~     of perioperative complications, as compared to non-obese parturients.2 Background: Obese~     patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore,~     obese patients have a higher incidence of perioperative complications, especially wound~     infections, and this is well documented in the caesarean section population. The pregnant~     population is unique as a result of the immunologic changes that occur at baseline, and an~     increase in pro-inflammatory markers is seen in serum and in placental tissue of obese~     subjects, and has been demonstrated to correlate with adverse fetal outcomes.~      Specific Objectives: To determine the baseline levels of three established markers of~     inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35~     kg/M2 respectively), and examine how they change in response to the stress of~     surgery/anesthesia. The investigators will correlate the inflammatory response with the~     incidence of postoperative wound infections.~      Methods: Patients will be recruited to the study prior to the planned caesarean section.~     Blood samples for inflammatory marker levels will be performed preoperatively, immediately~     postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3~     (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and~     clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established~     anti-inflammatory marker). Plasma will be analyzed by ELISA to determine levels of each~     biomarker. Patient charts will be reviewed to determine which patients have experienced~     surgical complications in the 30 days postoperatively. Surgical complications will then be~     correlated with the measured levels of inflammatory markers.~      Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in~     obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the~     investigators would need to study 18 patients per group to prove our hypothesis that~     inflammatory cytokine levels are correlated with postoperative infections. The investigators~     plan to study 20 patients per group to account for a potential patient attrition rate of 10%~     during the study.~      Significance/Importance: The connection between obesity and dysregulation of the~     perioperative inflammatory response has not been well established nor has perioperative~     inflammation in the obese population been linked to the observed increased in perioperative~     morbidity. The investigators hope to demonstrate these connections and hopefully will be~     able to identify at risk patients earlier, and in a subsequent study intervene to reduce the~     risk of postoperative wound infections with pharmacokinetically targeted antimicrobial~     prophylaxis.~   "
93274|NCT01836302|"~     Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A~     potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is~     associated with high rates of delirium.~      The aim of this pilot study is two fold. First, to determine the feasibility and potential~     challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic~     shock. And second, to see if the incidence and magnitude of cerebral desaturations~     correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM)~     scores.~   "
93275|NCT01836289|"~     This research is being done to see if people with Crohn's disease who receive high-dose~     cyclophosphamide have an improvement of their disease, how long the benefit may last, and~     how safe cyclophosphamide is. This study is for patient with medically refractory disease~     that is not easily amenable to surgery.~      Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to~     treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by~     the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting~     the cells, tissues, and organs of a person's own body. There are many different autoimmune~     diseases and they can each affect the body is different ways. Crohn's disease is an~     autoimmune disease that primarily affects the small and large intestines. High~     dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a~     conditioning regimen for autologous stem cell transplantation. However, this therapy is~     limited in Crohn's because of it's serious infectious risks. This current study involves~     using high-dose cyclophosphamide without need for stem cell transplantation. This appears to~     be a safer approach in other autoimmune illnesses that have been studied.~   "
93276|NCT01836276|"~     The purpose of this study is to describe the differences in quitting smoking between African~     Americans (AA) and White smokers treated with varenicline.~   "
93398|NCT01834638|"~     This is a study of ABT-126 in the treatment of cognitive impairment associated with~     schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).~   "
93277|NCT01836263|"~     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the~     skin and several internal organs.~      Digital ulcers are frequent and have a major impact on the quality of life in patients with~     systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the~     principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and~     inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy.~     Consequently, there are at least three types of DU: (i) those localized at the tips of the~     fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the~     dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences~     seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous~     calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent~     or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality~     of life and spare the enormous costs due to conventional digital ulcer management.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis.~      Aim of this observational trial is:~        1. To identify the best treatment combination for prevention of digital ulcers in patients~          with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria~          for very early diagnosis of systemic sclerosis~        2. To identify the best treatment associated with improved healing of digital ulcers in~          patients with fulfilment of the new ACR/EULAR SSc criteria~      Thus, the observational trial consist of a prevention arm and a healing arm.~   "
93278|NCT01836237|"~     Background: There are no published studies regarding the use of wound protectors in the~     context of surgical site infection (SSI) rates among patients receiving a~     pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high~     volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative~     biliary stent placement for bile duct decompression represents the norm given typical~     surgical wait times. In addition to having higher associated lengths of hospital stay, ICU~     admissions, hospital re-admissions, and overall mortality, patients with SSI are also~     delayed, and often omitted, in their progression to critical oncologic adjuvant~     chemotherapy. As a result, SSI remain crucial and devastating complications for pancreas~     surgeons and their patients alike.~      Methods: The investigators will complete a randomized controlled trial evaluating the rate~     of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent~     placement when wound protectors are employed versus no wound protector use. This trial will~     employ block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB)~     surgeons will participate with a planned inclusion of all patients scheduled to undergo a~     pancreatoduodenectomy.~      Analysis: The investigators will use an intention to treat approach to the analysis.~     Categorical baseline data will be analyzed using the Fisher exact probability test.~     Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be~     determined using the Fisher exact probability test.~      Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a~     pancreatoduodenectomy with preoperatively placed intrabiliary stents.~      Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI~     following pancreatoduodenectomy, the epidemic incidence of this complication must be~     reduced. The additional crippling effect of refusing (Medicare) payment for any patient who~     receives a SSI in the United States has launched all techniques and analyses that can~     potentially reduce this complication into the National health care agenda. In Canada, health~     care utilization and economics are always a relevant and ever expanding area of importance.~     It is crucial that the investigators reduce complications such as SSI, regardless of~     individual payer sources.~   "
93279|NCT01836224|"~     The Patient evaluated in Emergency room since admission and detailed history and clinical~     examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive~     Care Unit (ICU) in view of septic shock were included since onset of shock.~      Initial fluid resuscitation done and if the patient were no fluid responsive they were~     randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the~     primary objectives. At the same time the strict vitals monitoring and standard medical~     therapy for sepsis including antibiotics and other supportive therapy continued. The~     patients were followed up till discharge, death or up to 28days after enrollment into the~     protocol (whichever the longest). The detail methodology has been explained in column 14~     later.~   "
93280|NCT01836211|"~     -  The purpose of this study is to determine the efficacy and safety of an evaluation~          strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed~          by coronary computed tomography angiography (CCTA) in patients with low-intermediate~          risk chest pain consistent with a possible acute coronary syndrome compared to a~          standard of care (SOC) strategy.~        -  Unicentric, randomized, controlled, open label clinical trial that will compare a fast~          strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac~          biomarkers followed by stress/rest imaging study).~   "
93281|NCT01836198|"~     The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and~     clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes~     to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part~     A are divided into two cohorts (groups). Each cohort will participate in two study periods.~     Period one involves a single dose of LY2409021. Period two involves either gemfibrozil or~     ketoconazole for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days~     and will also involve screening within 27 days of the start of the study. Part B is only~     open to participants who successfully completed Part A of the study. Participants in Part B~     will receive one single dose of LY2409021 on Day 4 and clarithromycin for 21 days. Part B~     will last for 29 days and will also involve screening within 27 days of the start of the~     study.~   "
93282|NCT01836185|"~     The purpose of this study is to measure how much of the drug gets into the bloodstream and~     how long it takes the body to remove it when given to participants with hepatic (liver)~     impairment compared to participants with normal hepatic function. Information about any side~     effects that may occur will also be collected. This study will last approximately 28 days,~     not including screening.~   "
93283|NCT01836172|"~     The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the~     treatment of endothelial dysfunction in patients with diabetes mellitus.~   "
93284|NCT01836159|"~     A pilot randomized, two parallel group study comparing an iPad software game application~     versus standard care in post-stroke patients.~      Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially~     efficacious tool which has the potential to promote fine motor recovery of the upper~     extremity after stroke.~   "
93285|NCT01836146|"~     The purpose of this First-in-Human Clinical investigation is to evaluate the safety and~     performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the~     treatment of patients with drug-resistant uncontrolled hypertension.~   "
93449|NCT01833975|"~     This Study is a single arm,Phase I/II , single centre trial to check active comparing the~     safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be~     conducted for 36 months.~   "
93288|NCT01836107|"~     The purpose of this study is to make a Spanish version of a score that evaluates the~     characteristics of a good quality clinical note for the purpose of physician communication.~     The score is an instrument, originally made in English. Due to the score will be used in a~     different country, language and culture of the original protocol, it is necessary apply a~     process of translation and adaptation to the context where the score is going to be applied.~      The process of validation implies to evaluate if the instrument produces the same results~     under similar conditions and if the instrument maintains the ability to measure the same~     features or characteristics according to the original design.~   "
93289|NCT01836094|"~     The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i)~     improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction~     time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as~     measured by functional magnetic resonance imaging (fMRI).~      A single low-dose MB or placebo will be orally administered to self-declared healthy adults~     using double-blind study design. Non-invasive fMRI data will be acquired before and after MB~     administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour~     break in between.~   "
93290|NCT01836081|"~     The aim of this study is to investigate usefulness of the respirophasic variation in carotid~     artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily~     accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.~   "
93291|NCT01836068|"~     To find out if it is possible for HIV-1 patients to maintain antiretroviral medications~     during allogeneic bone marrow transplant~   "
93292|NCT01836055|"~     -  The investigators are conducting a magnetic resonance imaging (MRI) study comparing two~          MRI contrast agents in people with clinically isolated syndrome and relapsing remitting~          multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter~          in the brain. MRI is used as a gold standard to visualize the degenerative changes in~          the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis~          of MS using conventional imaging methods. These images reveal two main pieces of~          information regarding (a) the location of the lesions and (b) the status of the~          lesions. While the location of the lesions directly correlates with the clinical~          symptoms, the information about the status of the lesions informs the neurologist~          whether the lesion is new (active) or old (chronic).~        -  This ability to differentiate new and old lesions requires the use of a contrast agent.~          Currently, used agents reveal some lesions but it is unclear if they reveal the full~          extent of the disease. In new lesions, there may be a leakiness in the blood vessels~          and if the contrast agent leaks out then the investigators can see this. In healthy~          controls, the blood brain barrier is usually intact and this leak does not happen. One~          open question is: can the extravasation of the contrast agent to the brain precede the~          major tissue damage that we see in the structural MRI?~        -  Recently, a new FDA approved contrast agent (Gadavist) has been released and has~          enhanced characteristics in terms of affecting the MR signal resulting in a better~          contrast in the image and therefore, better diagnosis of the status of the disease.~          Given its high relaxivity, a small amount of Gadavist may show a better signal~          enhancement affected tissue for multiple sclerosis patients. The investigators~          hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and,~          therefore, may present a better tool for early diagnosis of brain damage.~        -  The investigators' goal in this research project is to see if the newer contrast agent~          is able to detect changes and differentiate healthy from affected tissue in the white~          matter and gray matter earlier than current contrast agents so that detection can be~          possible before major damage occurs to the tissue. Each person will be scanned~          initially with one agent and then between 8 and 30 days later with the other agent. The~          MR data processing results will be compared to check the efficacy of each contrast~          agent.~   "
93293|NCT01836042|"~     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®~     Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos~     Study GC-003.~   "
93294|NCT01836029|"~     The purpose of this study is to compare the progression-free survival of patients with~     recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with~     VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with~     cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and~     overall survival will also be evaluated.~   "
93295|NCT01836016|"~     The aim of this study is to compare the effectiveness and economic evaluation of three~     treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional~     medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and~     Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have~     certain effect; and finally, combination of both conventional medicine and TCM treatment,~     then determine which treatment is the most suitable for COPD patients.~   "
93296|NCT01836003|"~     Access to highly active antiretroviral therapy can improve maternal health outcomes for the~     4000 HIV- infected women who give birth daily and nearly eliminate transmission of HIV to~     their infants. However, system inefficiencies, particularly CD4 testing to determine~     treatment eligibility, are barriers. The project aims to study the effectiveness of a~     programmatic intervention at improving antenatal access to treatment.~   "
93297|NCT01835990|"~     Trauma patients are at a high risk of developing blood clots in the legs (deep vein~     thrombosis - DVT), which can travel to the lungs and cause serious health consequences.~     Often, these patients cannot receive blood-thinning medication to prevent these blood clots~     because of the risk of bleeding; in this case, they are usually given intermittent pneumatic~     compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over~     the legs and periodically inflate and deflate, helping to pump blood out of the legs and~     thus reduce the risk of blood clot formation. Several studies suggest that IPCs are working~     properly on the patient only 60-70% of the time. Some patients also find them uncomfortable.~     A new device (geko) that works by stimulating the leg muscles and increasing blood flow in~     the legs has recently been developed. To compare the geko with IPCs, this study will~     randomly assign trauma patients who cannot receive blood thinners for blood clot prevention~     to either IPCs or geko. The main goal is to determine the feasibility of doing a larger~     study which would compare the efficacy of these devices in preventing blood clots. The~     amount of time the devices are properly used on the patients, comfort and tolerability,~     development of blood clots, and blood flow in the leg veins and arteries will also be~     measured and compared between the devices.~   "
93318|NCT01835704|"~     To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are~     referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to~     measure the health-related quality of life at the first visit and then during the following~     year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With~     this and calculations of the cost we will be able to calculate the cost per QALY-gained~     which makes it possible to compare interventional pain managment to other treatments for~     pain patients.~   "
93319|NCT01835691|"~     This study is to research two questions. First, is vitamin D3 more effective than vitamin D2~     in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients?~     And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other~     mineral metabolism parameters?~   "
93298|NCT01835977|"~     Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume~     low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4)~     will undergo an IRE treatment. These patients will be randomized into one of the two groups~     of the study.~      Group 1: Focal ablation of the prostate at the side of the positive biopsies~     (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation)~      Patients will have an ultrasound of the prostate and the imaging data will be entered into~     the Planning Software system of the IRE-device. The volume of the prostate is measured and a~     specified ablation zone will be determined. The patients will be admitted for overnight stay~     in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed~     under general anaesthetic and the specified zone identified in the planning stage will be~     ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound~     image guidance with a perineal approach using a brachytherapy grid. When the needles are in~     place, electric pulses of one to two minutes duration are used to ablate the specified zone.~     The total procedure time will be approximately 1 hour.~      Safety data will be collected and patients will be followed up at 1 day post-operatively, 1~     month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.~   "
93299|NCT01835964|"~     The purpose of this study is to investigate how blood sugar changes in response to insulin~     and what the body does to counter-act low blood sugar in people with Type 1 Diabetes~     Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the~     body in response to insulin. Greater understanding of insulin sensitivity, particularly how~     the body responds to low blood sugar, will help us to better predict how blood sugar levels~     will change.~      All subjects will receive a liquid mixed-meal and will have their blood sugar response~     monitored in order to study insulin sensitivity. All subjects will receive additional~     insulin injections that are given to cause a low blood sugar in order to understand how the~     body responds to a low blood sugar. All subjects will be closely monitored during the time~     the insulin is given, by frequent checks of blood sugar and constant medical and nursing~     supervision. Details of the visits, tests and procedures are described below. During this~     study, the study team will ask that subjects to use their own insulin pump and own~     glucometer. Subjects will need to use the same glucometer for the entire study. Subjects~     will be provided 1 box of strips. Subjects will be required to use lispro (Humalog) insulin~     2-3 days before your inpatient admission which will be provided free of charge.~   "
93300|NCT01835951|"~     Simulation-based training is essential in learning or maintaining skills in high risk~     industry such as aviation and railway and in the medical field like anaesthesia. Debriefing~     following simulation is fundamental in order to reduce the emotional impact of the session~     and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing~     method is still to be found, individual debriefing is considered as the gold standard but~     time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and~     randomized study that will compare the individual (defined by learning couple resident and~     nurse) approach to a grouped (several couples) debriefing. The primary end point is to~     define the noninferiority of this approach compared to the individual one on the educational~     impact.~      The learners will be debriefed according to their randomization after the first session, but~     will all undergo individual debriefing following the second session.~   "
93301|NCT01835938|"~     Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and~     hepatocellular carcinoma world-wide. Current combination therapy of pegylated~     interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial~     side effects.~      The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV~     infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM)~     broadly inhibits HCV infection of all major genotypes including viral escape variants~     resistant to host immune responses.~      Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems~     demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral~     approach for prevention and treatment of HCV infection (European patent application EP 08~     305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al.~     Nature Medicine 2011).~      Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a~     well characterized safety profile in humans, the aim of the study is to investigate the~     safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for~     treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in~     patients chronically infected with HCV. Following completion, this trial will set the stage~     for a further investigation of entry inhibitors as antivirals in combination with standard~     of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical~     trial will be an important step in the development of novel urgently needed antiviral~     therapies overcoming resistance.~   "
93302|NCT01835925|"~     The purpose of this study is to study which genes are abnormal in rectal cancer and see if~     this predicts how well chemotherapy and radiation will reduce the size of cancer and whether~     cancer recurs after surgery.~   "
93303|NCT01835912|"~     Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via~     liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies~     have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from~     active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate~     transporter as the gradient of intracellular versus extracellular H+ increases. Therefore,~     artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular~     acidosis and increase the time to fatigue - defined as a decrease in force production with~     an increased perception of effort. The investigators will test the null hypothesis that~     sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance~     compared to placebo.~   "
93304|NCT01835899|"~     To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of~     BI 1015550 in healthy male volunteers~   "
93305|NCT01835886|"~     To determine if stair climbing can be used as a measure of progress in persons with~     pulmonary disease.~   "
93331|NCT01835535|"~     The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the~     safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:~        -  TIVUS™ Severe Resistant HTN Cohort~        -  TIVUS™ Moderate Resistant HTN Cohort~        -  TIVUS™ Failed RF Therapy Cohort~   "
93306|NCT01835873|"~     Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia~     obstetric deliveries because of the ability to use fewer drugs, a more direct experience of~     childbirth and the capability to provide excellent postoperative analgesia. However, the~     incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead~     to maternal and fetal morbidities. Certain interventions may reduce the incidence and~     severity of spinal anesthesia induced hypotension, including the use of vasopressors and~     intravenous pre- or co-hydration using different types of volume expanders; crystalloid or~     colloid solutions. Such interventions aim to increase maternal cardiac output, which is the~     key in attenuating the hypotensive response to spinal anesthesia.~      The primary purpose of this study is to compare the efficacy of intravenous prehydration~     (preloading) of healthy parturients scheduled for caesarean section with either a~     crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of~     hypotension after spinal anesthesia.~      The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by~     employment of a minimally invasive technique based on arterial pulse contour analysis.~     Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a~     secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal~     outcome, intraoperative side effects and maternal satisfaction scores.~   "
93307|NCT01835860|"~     To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative~     treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold~     standard surgical treatment- Transurethral Resection of Prostate (TURP).~   "
93308|NCT01835847|"~     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium~     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action~     (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent~     depression.~      The purpose of this research is to confirm the effect by carrying out the additional dosage~     of the Tipepidine Hibenzate to the adolescent patients with depression.~      If suggestion is obtained by this research about the effect on adolescent patients with~     depression of Tipepidine Hibenzate, it can contribute to development of the medical~     treatment of adolescent patients with depression.~   "
93309|NCT01835834|"~     To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded~     Zirconia on natural teeth in the posterior region for a period of 5 years. The working~     hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges~     of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded~     Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings~     (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference~     level of 95%.~   "
93310|NCT01835821|"~     This clinical study has the objective to compare the longevity and the clinical behaviour~     (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic~     crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full~     contour crowns IPS e.max CAD lithium disilicate on molars.~   "
93311|NCT01835808|"~     Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve~     (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a~     randomised trial - the FAME trial - where it was showed to be superior to classic anatomical~     evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A~     recommendation) when objective evidence of vessel-related ischemia is not available. Since~     the FAME trial was published, FFR use increased dramatically in most European countries,~     Portugal being no exception to this trend. FFR is currently being used in many~     interventional cardiology centres quite beyond the European Guidelines recommendation, since~     many physicians now trust more on the information they can collect with pressure-wire during~     the angiography, and less on non invasive imaging stress tests.~      Considering this widespread use of FFR in the evaluation of patients with CAD, there is a~     need to clarify the clinical results of this approach in a real patient setting. The~     Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was~     planned to evaluate if the use of FFR in the decision of coronary revascularization is~     feasible and allows optimized clinical results in real world non selected patients, as~     showed in clinical randomised trials.~   "
93312|NCT01835795|"~     The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in~     myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and~     imaging exams.~   "
93313|NCT01835782|"~     The purpose of this study is to determine the safety of L-Serine in subjects with~     Amyotrophic Lateral Sclerosis (ALS) at varied doses.~   "
93314|NCT01835756|"~     The purpose of this study is to determine whether the Erchonia® ML Scanner (MLS) is~     effective in the treatment of acute minor episodic chronic low back pain of musculoskeletal~     origin.~   "
93315|NCT01835743|"~     The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the~     treatment of chronic heel pain arising from plantar fasciitis.~   "
93316|NCT01835730|"~     This study is a first-in-human randomized, double-blind (Investigator and subject), placebo~     controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo~     per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).~   "
93317|NCT01835717|"~     Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when~     changes in the brain occur. In this long asymptomatic period or preclinical phase, studies~     with populations at risk of developing AD have shown cognitive differences compared to~     control groups without such risk. There is a need for short, sensitive, easily administered,~     reproducible, non-expensive and independent of socio-demographic influences tests enabling~     the detection of pre-symptomatic variations in memory, when the memory decline is still~     within a normal range.~      Study hypothesis: When evaluated with high-demanding tests of memory and executive function,~     the cognitive performance of cognitive healthy people aged between 45 and 65, will vary~     significantly depending on clinical, socio-demographic and genetic features~   "
93332|NCT01835522|"~     The goal of this study is to survey patients with a diagnosis of schizophrenia to determine~     if there is a relationship between self-reported sexual function and treatment with~     antipsychotic medication.~      Hypotheses: 1. Patients on typical antipsychotics will rate their sexual function as lower~     than those on atypical agents. 2. Patients on multiple antipsychotics will rate their sexual~     function as lower than those on a single agent.~   "
93320|NCT01835678|"~     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide, affecting 171~     million people in 2000 and an expected 366 million people in 2030 (1) and therefore diabetic~     nephropathy is rapidly increasing in the Western hemisphere and represents in up to 50 % the~     cause of end stage renal disease. Hence, early intervention is desirable to prevent any~     damage to the kidneys. In the early stage of diabetic nephropathy, endothelium dysfunction~     is a key pathogenetic process as indicated by increased leakage of albumin through the~     glomerular barrier (2).~      Hence, improvement of endothelium function is an attractive therapeutic goal of antidiabetic~     medication. Endothelial dysfunction, in particular basal nitric oxide activity, has been~     also identified as pivotal determinant of glomerular filtration rate (3).~      A new and promising class of antidiabetic drugs are the gliptins. Gliptins act by inhibiting~     the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for the rapid inactivation~     of glucagon-like peptide-1 (GLP-1) - an incretin hormone of the gut (6 - 8), thereby~     enhancing and prolonging the effects of GLP-1. GLP-1 - member of the incretin hormones - is~     released into the blood after meal ingestion and stimulates the insulin secretion in a~     glucose dependent manner. This accounts for the marked prandial insulin response, which~     prevents prandial hyperglycemia.~      Apart from surrogate parameters like reduction of fasting and postprandial blood glucose~     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function~     and cardiovascular outcome has not been the primary focus of current studies. However,~     infusion of GLP-1, the incretin hormone affected by gliptins has been reported to ameliorate~     endothelial dysfunction in patients suffering from coronary artery disease (9) and it was~     recently shown that infusion of GLP-1 into healthy human subjects increases both normal and~     ACh-induced vasodilatation (10). In studies on rats with diabetes, GLP-1 infusion nearly~     re-established their normal vascular tone (11) and there are further data from experimental~     animals that indicate a beneficial effect of GLP-1 on endothelial function (12).~      It is of major interest whether therapy with gliptins improves endothelial function of the~     micro- and macrovasculature. In face of the burden that diabetic nephropathy causes, the~     effect of linagliptin on the renal vasculature and endothelium integrity of the renal~     circulation (as measured by the availability of nitric oxide), is a key stone in order to~     claim that linagliptin is an effective antidiabetic agents. There is a need to demonstrate~     that linagliptin is effective beyond its blood glucose lowering actions and improves~     vascular endothelium function in the kidney.~   "
93321|NCT01835665|"~     The purpose of this study is to determine the maximum tolerated dose of nimodipine as well~     as the safety and tolerability of oral nimodipine in progranulin mutation carriers in~     preparation for longer term efficacy studies in patients with frontotemporal dementia due to~     progranulin gene mutations.~   "
93322|NCT01835652|"~     Parkinson's disease is caused by a reduction of dopamine causing motor deficits. The~     investigators are studying how exercise can help PD patients by increasing dopamine release~     in an area of the brain that coordinates movement, the striatum. The investigators will~     enroll PD patients into two groups; one group will complete a 12-week aerobic exercise~     program and the other will complete a 12-week control program including yoga and stretching~     only. The investigators will measure changes in dopamine release before and after either~     12-week intervention. Subjects will complete motor and cognitive questionnaires in addition~     to functional magnetic resonance imaging and positron emission tomography neuroimaging.~   "
93323|NCT01835639|"~     This multi-site, pilot study will assess vitamin D supplementation in children and young~     adults with Glomerular Disease. .~   "
93324|NCT01835626|"~     Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell~     carcinoma at most institutions. The purpose of this study is to determine whether adding~     vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study~     is to assess the safety and tolerability of combined radiation therapy and vismodegib. This~     combination may increase the chances of the tumors being destroyed or unable to spread to~     other parts of the body in people with locally advanced basal cell carcinoma of the head and~     neck.~   "
93325|NCT01835613|"~     The purpose of this study is to assess the clinical response to IL-6 inhibition defined as~     Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation~     between the biomarkers and treatment response.~   "
93326|NCT01835600|"~     For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed~     under general anesthesia with interrupted suspension of mechanical ventilation, which could~     result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10~     cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time~     of ventilation suspension but have no effect on carbon dioxide retention in blood.~   "
93327|NCT01835587|"~     The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486~     (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT.~     Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute~     Myloid leukemia (AML) or Myelodysplastic Syndromes (MDS) as a potential curative therapy.~     However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the~     principal causes of fatal complications after transplantation. Azacitidine has significant~     activity in MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML~     patients after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient~     route of administration and an opportunity to deliver the drug over a prolonged schedule.~   "
93328|NCT01835574|"~     The Cambodia Integrated HIV and Drug Prevention Implementation Program project will~     implement and evaluate an integrated combination HIV prevention intervention: SMARTgirl Plus~     for Cambodian female entertainment and sex workers where non-injection use of amphetamine~     type stimulant (ATS) is high and significantly contributing to HIV risk. SMARTgirl Plus will~     add demonstrated approaches to ATS and HIV prevention (conditional cash transfer (CCT) and~     microfinance (MF) opportunities) into an existing widely disseminated program (SMARTgirl),~     using a stepped wedge randomized cluster design, and assess impacts on HIV related risk~     behavior. Adding CCT and MF to existing HIV prevention programs will broaden the scope of~     the current prevention model which focuses principally on reducing sexual risk through~     condom use and STI care, and uptake of reproductive health services.~   "
93329|NCT01835561|"~     This study is for research purposes only and will not treat any disease or condition you may~     have. The study is an open label and single dose study; open label means that you, the study~     doctor and study staff will know which study drug you are taking.~      The purpose of this research study is to compare drug levels in the body of people with~     liver disease to drug levels in healthy people with a normal liver. In addition, the safety~     of the study drug will be studied. Information about any side effects (discomfort or decline~     in health) that may happen will be collected. The study drug will be given by mouth to~     subjects with liver disease and to healthy subjects.~      In the body, drugs are normally removed by the liver with a smaller amount being removed by~     the kidneys. When the liver is not working as well as it should, the body may not be able to~     remove drugs from the body quickly.~      The information from this study will be used to decide if the drug is safe in subjects with~     liver disease or if a lower dose of the study drug would be safer.~   "
93330|NCT01835548|"~     This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to~     evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit~     Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.~   "
93333|NCT01835509|"~     The primary aim of this randomized, controlled study is to evaluate the impact and~     feasibility of a prolonged physical activity intervention in school-aged childhood cancer~     survivors who self-report sedentary lifestyles. The study will test the hypothesis that~     childhood cancer survivors participating in a physical activity intervention guided by~     Social Cognitive Theory will increase the amount of time spent daily in moderate to vigorous~     physical activity, and improve exercise self-efficacy compared to children randomized to~     usual care. A secondary aim is to assess the impact of the intervention on cardiovascular~     risk factors including fitness and body composition.~   "
93334|NCT01835496|"~     The objective of this study is to evaluate the pharmacokinetics of deferiprone and its~     3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in~     patients with sickle cell disease.~   "
93335|NCT01835483|"~     To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping~     Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.~   "
93336|NCT01835470|"~     The purpose of this study is to assess the efficacy of Abatacept after intravenous~     administration in Japanese children and adolescents with active juvenile idiopathic~     arthritis who have a history of an inadequate response or intolerance to Methotrexate or~     biologics~   "
93337|NCT01835457|"~     Auto-immune diseases are characterized by an inappropriate inflammatory response against~     tissues in the body and represent a major health care burden. Pro-inflammatory cytokines~     such as TNF-α, IL-6 and IL-1β play a central role in the pathophysiology of many auto-immune~     diseases. Innovative therapies aimed at limiting pro-inflammatory cytokine production in a~     more physiological manner are warranted. In previous research conducted in an individual~     known as the iceman, the investigators found that, through a autodidact~     concentration/meditation technique, he appears to mount a controlled stress response,~     characterized by activation of the sympathetic nervous system and enhanced production of~     cortisol, both of which are known to result in immunosuppression. In accordance, while~     practicing this concentration/meditation technique, the inflammatory response during human~     endotoxemia (lipopolysaccharide [LPS] administration) was remarkably low in this individual.~     Therefore, this technique could provide a novel means of controlling the inflammatory~     response. However, the aforementioned results were obtained in just one subject, and hence~     can not serve as scientific evidence for the effectiveness of the concentration/meditation~     technique. The iceman claims that he can teach this technique to other subjects within a~     relatively short time frame. Therefore, in the present study the investigators wish to~     investigate the effect of concentration/meditation on autonomic nervous system activity and~     the inflammatory response during experimental human endotoxemia in a controlled manner, by~     comparing a group of subjects that are trained by the iceman and practice the~     concentration/meditation technique with a group of subjects which do not.~   "
93338|NCT01835444|"~     Reallocation of healthcare is one solution to the problems healthcare is facing. In the~     Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been~     studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and~     efficacy of (Dutch) PA services.~      This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of~     substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model~     in which the role of house officer is taken by medical doctors MD model) will be compared~     with a mixed model in which a PA functions as house officer together with a medical doctor~     (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e.~     academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD~     model compared to the MD model reduces the costs of healthcare, while improving or~     maintaining the clinical outcomes, patients and provider satisfaction, and continuity and~     quality of care.~      Primary research question:~      • What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?~      Secondary research questions:~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and~          patients outcomes?~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of~          care?~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and~          (specialist) medicals doctor experiences?~        -  What are the barriers and facilitating factors considering the implementation of PAs as~          house officer?~   "
93339|NCT01835431|"~     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is~     to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus~     insulin aspart for the remaining meals in children and adolescents with type 1 diabetes~     mellitus.~   "
93340|NCT01835418|"~     This study seeks to compare the differences in effectiveness among individual patients~     treated at for hypertension with bedtime administration of amlodipine versus lisinopril.~     There will be an analysis of whether one medication was more effective than another and~     whether specific patient factors could predict who responded better to which one.~   "
93341|NCT01835405|"~     To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety~     of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the~     topical closure of surgical wounds.~   "
93342|NCT01835392|"~     The purpose of this study is to look at whether the use of a simple technique before~     surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve~     development of language, motor and thinking skills at 12 months of age. Some research has~     found that a brief shortage of blood supply to an organ (such as a leg) at level that does~     not cause harm may help the body to tolerate a longer and more severe shortage of blood (for~     example, during surgery).~   "
93343|NCT01835379|"~     Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are~     available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.~     The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot~     ulcers to heal than wounds treated with regular medical care. Subjects will have their~     diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .~   "
93450|NCT01833962|"~     The purpose of this study is to assess fusion status in patients who underwent spinal fusion~     with Actifuse synthetic bone graft versus other bone graft material (including autograft) in~     achieving lumbar spinal fusion.~   "
93344|NCT01835353|"~     This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups~     of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following~     aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively.~     Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration~     immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing~     (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12~     function assay.~   "
93345|NCT01835340|"~     Propofol can be measured continuously in breath gas during anesthesia. This study compares~     propofol concentration in plasma and breath gas and processed electroencephalographic~     monitoring (bispectral index) under clinical conditions with patients and total intravenous~     anesthesia. Target controlled infusion technique is used to deliver adequate propofol~     concentration in plasma.~   "
93346|NCT01835327|"~     The current study proposes to address the question of whether patients' cerebral oxygen~     saturation levels are predictive of their recovery from thoracic surgery. Further, the study~     poses the hypothesis that a patient's poor recovery status goes on to increase a patient's~     risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium.~     The aim of this study is to address the observation that some patients struggle more than~     others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen~     desaturations and 2) that this may affect their post-operative morbidity. If a potential~     means of predicting poor outcomes is identified this will lead to further research into how~     to adjust the associated variables, such as cerebral oxygenation, to improve patient~     post-operative outcome.~   "
93347|NCT01835314|"~     Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a~     research study, therefore children will only be monitored on a clinical basis for seizure~     improvement predominantly by parent and caregiver report.~   "
93348|NCT01835301|"~     This study aims to test the hypothesis that plaque composition differs within a stent~     between bare metal stents and drug eluting stents (DES). It is possible that a difference in~     plaque composition seen within a stent may be contributory to the late thrombotic events~     seen more frequently with DES.~   "
93349|NCT01835288|"~     This phase II trial studies how well arsenic trioxide works in treating patients with~     relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic~     trioxide, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing.~   "
93350|NCT01835275|"~     The purpose of this study is to determine whether enhanced audio methods can be used to~     improve analgesia for experimental pain in healthy subjects.~   "
93351|NCT01835262|"~     The primary objectives of the study are to evaluate the efficacy of subdissociative dose~     intravenous ketamine compared with intravenous morphine in relieving acute pain in the ED.~     Secondary objectives will include the rate of adverse effects and need for rescue analgesia.~     The hypothesis is that intravenous administration of subdissociative dose ketamine at 0.3~     mg/kg is superior to intravenous morphine at 0.1mg/kg in treating moderate and severe acute~     pain in patients presenting to the ED.~   "
93352|NCT01835249|"~     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading~     cause of premature mortality worldwide. Early hypertension studies showed that treating~     elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause~     mortality. In subsequent research, patients achieved greater improvement in cardiovascular~     outcomes when their treatment was aimed at a moderate systolic BP target (<150mmHg) than at~     higher targets. Although observational data suggest that even lower BP targets may be~     beneficial, this has not been seen in randomized trials; instead, intense treatment of~     hypertension (i.e., to a target systolic BP <120mmHg) was found to have no effect on~     participants' risk for renal disease, cardiovascular disease, or all-cause mortality.~      One potential explanation for this apparent lack of benefit of intense BP targets is that~     the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory~     BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP~     measurements, nighttime systolic BP appears to be the best predictor of cardiovascular~     disease and all-cause mortality. Because recent trials assessing intense BP targets did not~     include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is~     largely unknown.~      To address this important gap in knowledge, we will conduct ABPM in 600 participants as part~     of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT).~     The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic~     based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of~     peak BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes~     approximately 9250 participants at high risk for cardiovascular disease.~      The investigators hypothesize that intense targeting of clinic systolic BP does not lower~     nighttime systolic BP compared to a standard target.~   "
93353|NCT01835236|"~     In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of~     care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is~     being combined with taxanes in the first-line setting. However, since therapy with~     trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal~     treatment strategy either in combination or in sequence with chemotherapy is still under~     debate. This randomized phase II trial is studying a new strategy for the treatment of~     metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab~     and pertuzumab, a treatment without chemotherapy. In case of disease progression,~     chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further~     line therapies are performed according to the physician's discretion. If this new~     therapeutic strategy is as effective and better tolerated than the conventional strategy,~     this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast~     cancer.~   "
93354|NCT01835223|"~     This phase I/II trial studies the side effects and best dose of tivozanib and to see how~     well it works in treating patients with liver cancer that has spread to other parts of the~     body or cannot be removed by surgery. Tivozanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
93363|NCT01835093|"~     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium~     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action~     (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit~     / Hyperactivity Disorder (AD/HD).~      The purpose of this research is to confirm the effect by carrying out the additional dosage~     of the Tipepidine Hibenzate to the AD/HD patients.~      If suggestion is obtained by this research about the effect on AD/HD of Tipepidine~     Hibenzate, it can contribute to development of the medical treatment of AD/HD.~   "
93451|NCT01833949|"~     The objective of our study was to compare the efficiency of the right ULOD using thermal~     doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to~     assess treatment efficiency.~   "
93355|NCT01835210|"~     Acne vulgaris is a common problem in the adolescent community. Past research has shown that~     acne affects teenager's self-esteem and mood. However, no research has evaluated the parent~     perception of their teenager's acne in comparison to the severity of acne and the patient's~     own reported quality of life. It is hypothesized that parents of teenagers underestimate how~     much acne vulgaris affects their teenager's skin disease-related quality of life. Also that~     teenager's perception of the severity of their acne is greater versus their parent's~     perception. We believe that increased acne severity based on clinician assessment will~     correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis~     of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1~     visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen~     quality of life survey (modified for parents), and 2 Likert scales will be completed. In~     addition, the clinician will score the teen's acne using the standardized Investigator~     Global Assessment tool. Statistical analysis will compare teen subject answers to the~     Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and~     differences between the clinician IGA score and Skindex-Teen responses~   "
93356|NCT01835197|"~     This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a~     Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.~   "
93357|NCT01835184|"~     This phase I trial studies the side effects and best dose of cabozantinib-s-malate when~     given together with vemurafenib in treating patients with solid tumors or melanoma that is~     metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
93358|NCT01835158|"~     This randomized phase II trial studies how well cabozantinib-s-malate works compared to~     sunitinib malate in treating patients with previously untreated kidney cancer that has~     spread from where it started to nearby tissue or lymph nodes or to other places in the body.~     Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether~     cabozantinib-s-malate is more effective than sunitinib malate in treating patients with~     kidney cancer.~   "
93359|NCT01835145|"~     This randomized phase II trial studies how well cabozantinib-s-malate works compared with~     temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma)~     that has spread to other parts of the body and cannot be removed by surgery.~     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. It is not yet known whether~     cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients~     with melanoma of the eye.~   "
93360|NCT01835132|"~     Background:~      - Scleritis is the inflammation of the white outer coating of the eye, known as the sclera.~     In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders~     such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen.~     More severe scleritis may need oral steroids or immunosuppressive treatments; however, these~     treatments can cause side effects in the whole body. Gevokizumab is a newer~     anti-inflammatory drug that is under investigation to treat other inflammatory diseases. It~     may not have as severe side effects as some other drugs. However, it has not yet been used~     to treat scleritis. Researchers want to see if it can be given as a safe and effective~     treatment for scleritis.~      Objectives:~      - To see if gevokizumab is a safe and effective treatment for scleritis.~      Eligibility:~      - Individuals at least 18 years of age who have active scleritis.~      Design:~        -  There is an initial phase and a two-part extension phase in this study. The extension~          phase is optional. The initial phase of the study requires seven visits to the National~          Eye Institute (NEI).~        -  Participants will be screened with a physical exam and eye exam, and medical history~          will be obtained. Blood and urine samples will be collected.~        -  Eligible participants will receive an injection of 60 mg of gevokizumab at the first~          study visit and at Weeks 4, 8, and 12. They will be given under the skin by the~          stomach, or in the upper arm or thigh.~        -  Participants will have additional visits after the first study visit at Weeks 2, 16,~          and 28. No injection will be given at these visits. Eye exams will be done, and blood~          and tear samples will be collected.~        -  If the scleritis improves by Week 16, participants may choose to continue the study in~          the extension phase. In the 1st extension, they will have a visit every 4 weeks until~          Week 36 and then two additional monitoring visits at Weeks 40 and 52 for a total of 13~          study visits.~        -  Participants who are eligible at Week 52 may continue in the as needed (PRN)~          extension phase (2nd extension) and receive gevokizumab injections (60 mg) at Weeks 52,~          54, 58 and 62.~   "
93361|NCT01835119|"~     Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea,~     vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the~     commonest reasons for delayed recovery and discharge from hospital following abdominal~     surgery. Advances in surgical techniques and peri-operative management such as the use of~     laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and~     mobilization, amongst others, have been shown to help in the resolution of postoperative~     ileus.~      Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by~     stimulating the cephalic phase of digestion and eliciting the release of multiple~     promotility GI hormones. A number of small controlled studies evaluating the effect of~     chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery~     have been conducted. Decreased time for bowel function recovery and decreased hospital~     length of stay have not been consistently documented, possibly owing to the insufficient~     power of existing studies and study design issues. In addition, all previous studies have~     been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol).~      In this study, gum chewing was studied for its effect on women with surgical staging for~     malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.~   "
93362|NCT01835106|"~     The investigators are investigating two ways of treating pain after hip surgery. One way is~     though a thin tube (called a catheter), and it is placed into the back so that pain-numbing~     drugs can reach the nerves near the backbone. This is called an epidural catheter. Another~     way is to place the catheter close to the hip, where the surgery is done, so that the~     pain-numbing drugs can reach some of the nerves more locally. This is called a fascia~     iliaca compartment catheter.~      The investigators do not know which way is best to treat pain, or has fewer side effects, or~     allows a patient to leave hospital faster. Usually, patients would receive only one type of~     catheter for pain relief. To do this comparison, the investigators would place both catheter~     types, so that patients help us tell which one works better.~   "
93387|NCT01834781|"~     The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is~     effective in the treatment of multiple chemical sensitivity in terms of life impact,~     symptoms, psychological distress, markers of central sensitization and the immune system,~     and quality of life.~   "
93364|NCT01835080|"~     The purpose of this study is to determine whether pulmonary arterial hypertension can worsen~     or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does~     indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying~     pulmonary arterial hypertension instead of the sleep apnea.~      To determine if a person has sleep apnea, they will undergo one overnight polysomnogram~     (sleep study). If it is found that they have mild to moderate sleep apnea, then the subject~     will be invited to continue in the study and their pulmonary arterial hypertension will be~     treated by their managing primary physician. After the subject has had treatment for their~     pulmonary arterial hypertension, the study center will have them return for a follow up~     sleep study to learn the effects of pulmonary arterial hypertension treatment management on~     their sleep apnea, 12-24 weeks after the first sleep study.~   "
93365|NCT01835067|"~     This study will recruit patients who have recently had a submacular haemorrhage (bleed under~     the part of the retina responsible for detailed vision), as a complication of wet~     age-related macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal~     blood vessels form under the retina and leak, causing a significant reduction in vision.~      The study will investigate treatment of the bleed with various combinations of the two~     drugs: tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and~     perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the~     retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke.~     C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four~     groups: control group that receive none of the above drugs; one group that receives only~     tPA; one group that receives only C3F8; and one group that receives both.~      All patients will receive the current gold standard treatment for wet AMD, ranibizumab~     (Lucentis®).~      The aim of the study is to improve vision in a condition, which left untreated, would cause~     severe visual loss.~   "
93366|NCT01835054|"~     Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America~     and in Europe, and its prevalence is increasing with the aging of the population. Organic~     Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of~     MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular~     mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet~     prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the~     most frequent cause of severe MR leading to surgery in the western world. However, the best~     current treatment for OMR remains uncertain and controversial. We have obtained preliminary~     data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at~     rest, as generally performed during routine clinical exam, does not necessarily reflect the~     status of MR during patient's daily activities and thereby does not adequately assess the~     risk of rapid progression and poor outcome in these patients. The objective of this study is~     to identify the independent predictors of disease progression and outcome in patients with~     asymptomatic chronic OMR and to develop and validate novel imaging and circulating~     biomarkers to improve risk stratification and therapeutic decision-making process in~     patients with chronic asymptomatic primary OMR.~   "
93367|NCT01835041|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together~     with combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs~     used in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride,~     and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing.~   "
93368|NCT01835028|"~     Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical~     LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both~     situations are amongst the most challenging encountered in patients with valvular heart~     disease. Although, CLF-LG AS is recognized has an important clinical entity, current~     ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical~     management of these patients . PLF-LG AS is a new entity recently described by our group,~     which is characterized by more pronounced LV concentric remodeling with smaller LV cavity~     size and a restrictive physiology leading to impaired LV filling, altered myocardial~     function, and a low-flow state. Up to recently, this entity was often misdiagnosed, leading~     to underestimation of AS severity and inappropriate delays for aortic valve replacement~     surgery (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to~     distinguish between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to~     accurately quantify the extent of myocardial impairment. Unfortunately, the traditional~     resting and stress echocardiographic parameters currently used to assess the severity of~     valvular and myocardial dysfunction in patients with LF-LG AS are far from being optimal,~     and as a consequence, quantification of disease severity and therapeutic management may not~     be appropriate in a substantial proportion of these patients.~      THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and~     biomarkers to improve the assessment of stenosis severity and myocardial impairment, the~     risk-stratification, and the clinical decision making in patients with LF-LG AS and to~     assess the impact of the different therapeutic strategies on patient outcomes.~   "
93369|NCT01835015|"~     The purpose of this study is to evaluate the safety, tolerability, and serum~     pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).~   "
93370|NCT01835002|"~     The purpose of this study is to determine the long term effects of transcorneal~     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study~     (NCT00804102) the results of short term stimulation pointed to a positive effect on the~     visual field and other parameters. In this study, the patients will be stimulated with the~     OkuStim device for half a year and safety parameters will be measured.~   "
93371|NCT01834989|"~     The purpose of the study is to test the hypothesis that stimulation of the synthesis of new~     structural tendon proteins combined with training improve the tendon structure in patients~     with chronic knee tendon pain.~   "
93372|NCT01834976|"~     The purpose of this study is to investigate cardiac biomarker during perioperative~     management in pediatric cardiac surgery.~   "
93373|NCT01834963|"~     To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy,~     interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with~     hepatocellular carcinoma with portal vein tumor thrombus.~   "
93374|NCT01834950|"~     The study is a single arm prospective study, aiming at identifying biomarkers of early~     response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of~     HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed~     by breast conserving surgery. The investigators will study the association between the value~     of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors~     response (partial and complete response) using a logistic regression (main analysis).~   "
93375|NCT01834937|"~     The purpose of this enhanced surveillance study (ESS) is to collect information regarding~     chronic adverse events that are possibly related to the ExAblate® System (ExAblate) that~     are received by InSightec (InSightec) following PMA approval. This study will examine~     adverse events reported in patients undergoing the device procedure for the first two years~     of commercial experience. Other relevant data may be collected as well.~   "
93376|NCT01834924|"~     Almost half of all US adults have trouble understanding and using health information, or low~     health literacy. Health literacy is considered to be an important patient safety issue, and~     has been linked to poor medication management. Low health literacy is a risk factor for~     parent errors in administering medications to their children; difficulty understanding~     provider medication instructions is likely to contribute to errors.~      To address these issues, bilingual (English/Spanish), low literacy, picture-based medication~     instruction sheets were developed. This study will look at the effectiveness and feasibility~     of the medication instruction sheet-based intervention as it is used by providers in 2~     pediatric emergency department settings, as part of a planned roll out of HELPix within the~     hospital system. The investigators hypothesize that there will be reduced medication dosing~     errors, improved medication adherence, reduced hospital revisit rates, and improved~     provider-parent communication. The investigators also hypothesize that provider technology~     experience, knowledge, and attitudes, will affect the extent to which providers use the~     tool.~   "
93377|NCT01834911|"~     Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve~     postural stability in Huntington disease (HD) patients as measured by computerized dynamic~     posturography testing. This study aims to elucidate whether partial dopaminergic depletion~     via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on~     the Stroop interference test.~   "
93378|NCT01834898|"~     The hypothesis of this study is that controlled release oxycodone can be safe and well~     tolerated for the control of postoperative pain in surgery for head and neck cancer. The~     primary objective is to study the safety and the incidence and severity of adverse effects,~     and the secondary objective is to evaluate the analgesic efficacy and identify the frequency~     of use of rescue medication and the prescribing physician's opinion about the quality of~     postoperative analgesia with oxycodone controlled release in oncologic surgery of the head~     and neck.~   "
93379|NCT01834885|"~     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in~     patients with moderate to severe airflow limitation~   "
93380|NCT01834872|"~     The aim of this prospective observational study is to evaluate the performance of Amigo RCS~     in ablation procedures for most common arrhythmias as compared to a conventional manual~     approach.~   "
93381|NCT01834859|"~     Very-low calorie diets are relatively safe and effective in inducing significant weight~     loss, when used in selective individuals and under clinical supervision. However, weight~     loss maintenance in the long-term remains the main challenge, with many experiencing a~     significant weight regain. Several compensatory mechanisms are activated under weight~     reduction, both at the level of energy intake (such as increased appetite) and energy~     expenditure (such as reduced energy expenditure), and increase the risk of relapse.~      The main aim of this study is to compare the effect of two multidisciplinary lifestyle~     interventions on weight loss maintenance at one year, after initial weight loss during 8~     weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an~     outpatient program in the obesity unit of the local hospital, or to an inpatient program~     consisting of a continuous care intervention, with three intermittent stays (each with~     three-week duration) in a rehabilitation center over a one year period. Moreover, the~     investigators aim to assess the impact of weight loss (achieved with a very low calorie~     diet) and weight loss maintenance on compensatory mechanisms activated during weight~     reduction.~   "
93382|NCT01834846|"~     The success of coronary artery bypass grafting is reliant on the quality of the grafts used.~     A new technique for harvesting veins used as grafts has been introduced. The study~     hypothesis is that veins harvested with this technique have an improved endothelial~     function.~   "
93383|NCT01834833|"~     Evaluate the benefit of systematic appointment with a cardiologist a week after~     hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of~     hospital during 6 months~   "
93384|NCT01834820|"~     In infancy, bronchiolitis is the most common acute infection of the lower respiratory Tract.~     The current treatment of bronchiolitis is controversial. Bronchodilators and corticosteroids~     are widely used but not routinely recommended. Hypertonic saline is currently the only drug~     recommended by the Spanish Association of Pediatrics in treatment guidelines.~      The purpose of this study is quantify whether epinephrine, dexamethasone, and hypertonic~     saline are effective to decrease the rate of hospital admissions at seven day, also verify~     adverse effects in patients submitted.~   "
93385|NCT01834807|"~     This retrospective, observational, multi-center study will evaluate the use of biological~     agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid~     arthritis. Data from medical record files will be collected of patients currently treated~     with a biologic in monotherapy.~   "
93386|NCT01834794|"~     This project aims to develop and test an intervention for the simultaneous treatment of~     cannabis use disorders and tobacco smoking. This is important because over 50% of adults~     seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases~     their chance for a successful treatment outcome and increases adverse acute and long-term~     psychosocial and health consequences. The proposed treatment will integrate existing~     computer-based behavioral interventions for cannabis and tobacco and use nicotine~     replacement medications to improve outcomes in this difficult to treat clinical population.~   "
97014|NCT01787175|"~     The purpose of this study is to advance the science of healthcare informatics and to improve~     medication management through the development of a new approach to the electronic medical~     record called the Integrated Medication Manager (IMM).~   "
93388|NCT01834768|"~     Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive~     drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A)~     are widely used. Their renal toxicity could be divided between an acute toxicity (toxic~     arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy,~     interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have~     shown the implication of the mineralocorticoid receptor (MR) activation in those toxic~     phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the~     renal function and kidney histological damages.~      Several antagonists are available in France but none is indicated in kidney transplantation.~     Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and~     to have less adverse anti-androgenic effects than others molecules. Its principal adverse~     events are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists,~     especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced~     by calcineurin-inhibitors.~      Classically, eplerenone is contra-indicated in patients presenting with an impaired renal~     function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a~     warning is especially notified for the association with cyclosporine A due to the fact that~     no study have been done in this context.~      The investigators study first the safety of the use of eplerenone in association with~     cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will~     study its efficiency in a large randomized controlled trial.~   "
93389|NCT01834755|"~     Highlighting the relationship between psychological and physical profiles and patient's~     preference to better understand the patient's treatment preference and improve the~     information provided.~   "
93390|NCT01834742|"~     This study is to investigate the effect of various modified low volume polyethylene glycol~     (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool~     output in healthy subjects. In addition, the study is to assess and compare the safety and~     tolerance of the modified PEG+ASC formulations following oral administration with the safety~     profile of MOVIPREP®.~   "
93391|NCT01834729|"~     This study is designed to better understand the effects of effects of stress, relaxation,~     and a medication alfuzosin on bowel control and emptying in healthy people and patients with~     bowel problems. Normally, bowel emptying requires relaxation of the anal sphincter (i.e.,~     lowermost end of intestinal tract) and pelvic muscles. Some people cannot relax these~     muscles normally and experience constipation. Alfuzosin is a medication which is approved to~     treat bladder but not bowel problems.~   "
93392|NCT01834716|"~     5.4 million Americans have Alzheimer's disease (AD) costing $185 billion annually, while 15~     million caregivers look after these individuals. AD is the sixth leading cause of death, but~     the only one in the top 10 causes that cannot be prevented.~      This study may demonstrate exercise in an amount attainable by many will be preventative in~     asymptomatic individuals including those with brain Abeta deposition already that are at~     impending risk of the disease. Sperling and colleagues(1) coined the research term~     AD-pathophysiological process (abbreviated AD-P) for use in studies such as the intervention~     in this proposal.~      Our long term goal is to assess whether exercise may be preventative of AD at older ages~     (=73, mean=75), when more than 40% of cognitively normal persons have A beta deposits, the~     hallmark of AD pathogenesis, in their brains. In a NIH RO1 grant submission the~     investigators proposed to conduct a partially blinded controlled preventative trial in 150~     cognitively normal individuals, randomized in a 2:1 ratio to 18 months of moderate aerobic~     exercise versus 18 months of toning and stretching. All persons would have baseline and 18~     month brain Abeta PET studies. The study was designed to determine whether an exercise~     intervention in persons mean age 75 would lead to decreased brain Abeta accumulation,~     increased hippocampal volume, improved cognition, and improved dementia-related biomarkers~     compared to the control group. The study would be unique in that the investigators would be~     able to examine if aerobic exercise slows the accumulation of brain Abeta in an older~     population, at which time Abeta deposition is common. If successful, this would provide an~     additional motivating reason to recommend exercise for most elderly persons.~   "
93393|NCT01834703|"~     This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine~     Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients~     with uterine fibroid.~   "
93394|NCT01834690|"~     Conventionally, the outcome of liver transplantation is usually reported in terms of graft~     and patient survival, medical and surgical complications, but lack of health-related quality~     of life (HRQOL) that might be associated with immunosuppression complications (e.g.,~     diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease,~     renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections~     after transplantation.~   "
93395|NCT01834677|"~     The purpose of this study is to evaluate the psychometric properties and utility of new,~     computerized, neurocognitive measures in humans with depression, and humans with depression~     undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as~     there is the possibility of developing better computerized neurocognitive measures, and the~     risks are limited to no more than minimal test related fatigue and psychological stress.~      Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with~     Parkinson's disease (age 18-85) will be invited to participate in this study. After~     providing informed consent participants will undergo a clinical psychiatric evaluation to~     confirm the inclusion/exclusion criteria. After the clinical psychiatric evaluation,~     participants will complete common and new neurocognitive measures. There will be a total of~     two testing visits (baseline, 1-month follow-up). The anticipated duration of the~     participant's involvement is no more than 2 study visits that can take place over a 4-day~     period (i.e., the clinical evaluation can occur on day 1 and the neuropsychological measures~     can be administered on day 2 of each study visit) equating to approximately 6-hours (3-hours~     each day) per study visit.~   "
93396|NCT01834664|"~     This Study is Single arm, Single Centre trial to study the safety and efficacy of bone~     marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration~     36 months sample size 100 patients should be treated (above 15 years of age) with cerebral~     palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait~     pattern.~   "
93399|NCT01834625|"~     In this pilot study the investigators shall prospectively in a blinded fashion evaluate with~     Aβ PET and CSF Aβ42 and tTau or pTau in patients committed to shunt surgery and then~     investigate the relationship of these biomarkers with outcome on gait, cognition and urinary~     control improvement in the short term (3 months) and long term (1 year). The imaging agent~     will be provided by AVID.~      Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide~     information on amyloid burden.~   "
93400|NCT01834612|"~     To determine if a manual blood loss can be detected using the non-invasive blood monitor.~   "
93401|NCT01834599|"~     To assess the potential of the cerebral oximeter to measure placental oxygenation~   "
93402|NCT01834586|"~     The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®,~     will reduce the injection pain. Relieving injection site pain may improve the tolerability~     of Multiple Sclerosis medications.~      Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings~     as measured by the visual analog scale and Local injection site reaction scale.~   "
93403|NCT01834573|"~     Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life~     compared to healthy adults. This is due to the chronic course of disease accompanied with~     diarrhea, stomach pains but also with psychological stress.~      It is known that physical education may improve course of disease and quality of life in a~     multitude of diseases. These include coronary heart disease, malignancies and also~     depression. The investigators believe that sport is as effective supportive tool in~     improving quality of life in IBD patients. But data is lacking with regard to controlled~     randomized clinical trials. Because of the small amount of data available the investigators~     considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate~     exercise. The investigators further suspect that these patients improve their quality of~     life compared with patients in the control group.~   "
93404|NCT01834560|"~     Despite the availability of several treatments, a number of patients with major depression~     are refractory to therapeutical approaches and therefore suffer from chronic handicap. For~     these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting~     bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the~     patients.~      This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In~     this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS)~     of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an~     alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the~     60s with satisfying results before neurosurgery for psychiatric disorders was abandoned.~     Since 1992, psychosurgical therapies that respect ethical recommendations have regained~     interest to treat highly impaired patients. Before the investigators can propose deep brain~     stimulation of subgenual cingulate brain region as a new therapeutic approach for the~     investigators patients in Grenoble, the investigators decided to reproduce their clinical~     evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore~     nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took~     advantage of the investigators own expertise regarding deep brain stimulation and subcaudate~     tractotomy.~      Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their~     preliminary results. Cartography of physiological consequences of this procedure will be~     assessed by measuring cerebral blood flow by PET scan (positron emission tomography).~     Patients will be monitored and thoroughly assessed during including psychiatric,~     neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment~     efficacy and potential adverse reactions. Patients will be followed for two more years to~     assess medium-term complications. This study will be a first step toward further research~     including potentially a multicentric clinical trial.~   "
93405|NCT01834547|"~     Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of~     chess players in chess games and neuropsychiatric standardized tests. We hypothesize that~     substances will change cognitive performance in chess players leading to changed results in~     chess games and neuropsychiatric tests.~   "
93406|NCT01834534|"~     The objective of this research is to test the efficacy of CarePartners for Depression~     (CP-D) intervention, which was designed to increase between visit monitoring of depression~     status and enhance self-management.~      **In order to participate, subjects must be patients at participating clinics: Alcona Health~     Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.~   "
93407|NCT01834521|"~     The ever expanding breast cancer survivor population urges the health care system to develop~     (cost-)effective screening and management of convalescent care needs that can be easily~     implemented in conventional follow-up care. Internet-delivered systems may be well-equipped~     to meet these demands. The aim of the current study is to assess the effectiveness of a~     web-based support system. Key features of this system are patient self-screening of physical~     and psychosocial problems, tailored patient education on reported problems and self-referral~     to professional care. In this era of high internet usage, we expect that internet is a~     highly suitable medium to provide tailored support for breast cancer patients and will~     empower the patient to take control over their convalescence.~   "
93408|NCT01834508|"~     The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5~     mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.~   "
93409|NCT01834495|"~     The purpose of the investigators study is to examine and compare primary patency between~     balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus~     COMPLETE-SE) in atherosclerotic iliac artery lesion.~   "
93410|NCT01834482|"~     The modified Atkins diet (MAD) has been shown to be effective in treating children and~     adults with medically resistant seizures. A recent study in children showed that the use of~     KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the~     first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak~     with one meal during the initial month of the MAD will produce urinary ketosis in more adult~     patients than the MAD alone and will lead to greater seizure reduction.~   "
93411|NCT01834469|"~     The purpose of this study is to determine if NIF fluorescent imaging is an effective~     approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian~     cancer patients.~   "
93452|NCT01833936|"~     Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to~     the immobilization period necessary to ensure optimal healing.~      The purpose of this study is to determine if the use of neuromuscular electrical stimulation~     (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.~   "
93453|NCT01833923|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd.~      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2~     and VEGFR3. It has the obvious resistance to new angiogenesis.~   "
93412|NCT01834456|"~     Under the auspice of 'Specially for Children and with funding from the Seton Healthcare~     Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated~     and integrated model of care for children with medical complexity. This model serves as the~     patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who~     work as hospitalists and within the PCP) and nurse practitioners to provide continuous care~     between hospital and primary care. This model seeks to provide a system of care that more~     fully meets the complex needs of the child and family, while implementing innovations in~     care delivery, fully implementing family-centered practice, and embedding behavioral,~     psychiatric, psychosocial, and palliative care. This study is a randomized intervention~     trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on~     two outcomes: utilization and cost of care; and, evaluation of the experience of parents and~     their families.~   "
93413|NCT01834443|"~     The purpose of this study is to determine whether galvanic vestibular stimulation is~     effective in the treatment of spatial neglect after right brain-damage.~   "
93414|NCT01834430|"~     Different studies suggest that early enteral nutrition (EEN) has benefits in reducing~     infectious complications, there is no data that addresses whether delayed enteral nutrition~     (EN) is detrimental and if it may have effects on inflammatory responses and immune~     function.~   "
93415|NCT01834417|"~     Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device.~     During this period, patients write in an agenda noteworthy events that could occur while~     they're using their wheelchair. A control is done every week and the device can be changed~     until it is returned at the end of the study period.~   "
93416|NCT01834404|"~     Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric~     emptying, gastric accommodation, satiety, and satiation in obese participants.~   "
93417|NCT01834391|"~     The purpose of this study is to see if the investigators can identify early those patients~     who are admitted to the hospital and have a urinary tract infection (UTI) or those patients~     that develop a UTI during their hospitalization.~   "
93418|NCT01834378|"~     We randomize individuals with impaired glucose tolerance to one of three arms for degree of~     physical activity: 1. Continue with your current life style; 2. Ordinary life activities for~     increased physical activity; 3. Scheduled group activities for changed behavior. The overall~     aim is to focus on change of physical activity and to keep other life style activities more~     or less unchanged (diet, smoking, etc) and the effect on metabolic variables.~   "
93419|NCT01834365|"~     There is a structured educational effect on blood pressure reduction in elderly hypertensive~     patients.~   "
93420|NCT01834352|"~     The purpose of this study is to determine if walnut oral immunotherapy can be used in~     subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in~     their immune system.~   "
93421|NCT01834339|"~     The purpose of this study is to compare the safety and effectiveness of performing oral~     reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or~     AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a~     type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.~   "
93422|NCT01834326|"~     The purpose of this study is to improve the current standard of care of repairing mouth soft~     tissue defects.~   "
93423|NCT01834313|"~     The purpose of this study is to evaluate the monetary value of patient-centrednes in health~     care by determining a willingness-to-pay for more patient-centredness care for both patients~     and health insurers~   "
93424|NCT01834300|"~     This project examines the effects of a 4 month structured exercise intervention program in~     patients with non-alcoholic fatty liver disease (NAFLD). We will examine changes in total~     and depot-specific (i.e.in different tissues, liver, muscle and pancreas)fat. We will~     correlate these with measurements of the insulin from the liver. The hypothesis is that by~     reducing fat in these specific depots we can reduce insulin resistance and prevent~     progression to diabetes.~   "
93425|NCT01834287|"~     In this study, investigators are specifically targeting Latina women as they are more likely~     to be inactive and, therefore, are at higher risk for developing chronic conditions such as~     obesity, diabetes, or cardiovascular disease.~      The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical~     Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact~     Control condition. Participants are randomly assigned to one of two groups (Exercise and~     General Wellness).~      The investigators hypothesize that at the end of treatment, intervention participants will~     report significantly more minutes of moderate intensity physical activity per week than the~     wellness contact control participants.~   "
93426|NCT01834274|"~     The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin~     compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment~     Period.~   "
93427|NCT01834261|"~     Oxytocin is a neuropeptide that is well known for its role in social and affiliative~     behavior in humans. Oxytocin receptors are significantly lowered in autistic individuals and~     administration of oxytocin has shown benefits in enhancing social recognition and behavior~     in autistic children. However, more recent research has refined the behavioral effects of~     oxytocin, moving away from the notion that the neuropeptide blindly induces love and trust,~     towards the view that it actually increases social perception in assessing friend vs. foe:~     supporting cohesion with 'insiders' and distrust and aggression for 'outsiders.' Oxytocin is~     responsible for the selective aggression shown by lactating female mammals protecting their~     young, an effect demonstrated also in humans, and has been shown to strengthen feelings of~     ethnocentrism. However, no neuroimaging study to date has investigated this effect, with the~     consequence that its neurobiological basis is still unknown.~      The general aim of our study is to determine meso-circuit brain dynamics that underlie~     oxytocin's amplification of both trust and aggression; and specifically, using neuroimaging~     (fMRI, magnetoencephalography, and behavioral testing) whether oxytocin amplifies kinship~     bias by attenuating social reward learning.~      DATA COLLECTION CURRENTLY OCCURS IN BOSTON MA~   "
93488|NCT01833468|"~     Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of~     the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The~     functional status of the SpA patients are usually evaluated globally.The aim of this study~     is to assess specifically the foot -related functional limitations of the SpA patients.~   "
93428|NCT01834248|"~     This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion~     protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid~     leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1~     protein sequence fused to a monoclonal antibody against DEC-205, a surface marker present on~     many immune stimulatory cells. This drug is given with another substance called PolyICLC,~     which acts to provoke any immune stimulatory cells which encounter the NY-ESO-1-DEC-205~     fusion protein to produce an immune response signal against NY-ESO-1. Immune cells which~     have thus been primed to react against NY-ESO-1 may then attack myelodysplastic or leukemic~     cells which express NY-ESO-1 after exposure to the drug decitabine. The chemotherapy drug~     decitabine is thought to act in several different ways, first, it may directly kill cancer~     cells, and secondly, the drug can cause cancer cells to re-express genes that are turned off~     by the cancer, including the gene for NY-ESO-1. Giving DEC-205/NY-ESO-1 fusion protein~     (CDX-1401) and polyICLC together with decitabine may allow the immune system to more~     effectively recognize cancer cells and kill them.~   "
93429|NCT01834235|"~     This is a randomized phase II multi-institution prospective open label study in which up to~     90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer~     who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like~     regimen will be enrolled into one of two arms:~      A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel~   "
93430|NCT01834222|"~     The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean~     adults in the routine clinical setting, as required for any new drug approved by Korea Food~     and Drug Administration (KFDA).~   "
93431|NCT01834209|"~     The purpose of this study is to collect additional safety data during treatment with~     abiraterone acetate plus prednisone or prednisolone among adult participants with~     asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC)~     who reside in areas in which abiraterone acetate is not yet available for this indication~     through local healthcare providers, and who are not eligible for enrollment into an~     available ongoing clinical study of abiraterone acetate.~   "
93432|NCT01834196|"~     This is a clinical pilot study to assess the feasibility of using a swept-source optical~     coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal~     vasculature in patients with existing microvascular disease.~   "
93433|NCT01834183|"~     This research study is a PHase II clinical trial, which tests the safety and effectiveness~     of an investigational combination of drugs to learn whether the combination of drugs works~     in treating a specific cancer. Investigational means that the combination of drugs is~     being studied. It also means that the FDA has not yet approved these drugs or combination of~     drugs for use in participants, including people with your type of cancer.~      Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood~     supply so that it does not get the blood and nutrients it needs to grow. This drug has been~     used in other research studies and information from those other research studies suggests~     that this drug may help to slow the growth of cancer cells.~      Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of~     pancreatic cancer and several other cancers. It is not approved for the treatment of renal~     cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have~     some effectiveness in treating metastatic renal cell carcinoma.~      The purpose of this research study is to determine the effectiveness of tivozanib as a~     treatment for renal cell carcinoma. The purpose of this research study is to also determine~     if the combination of tivozanib and gemcitabine is effective in treating your type of cancer~     if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The~     safety of the combination of tivozanib and gemcitabine will also wbe studied.~      Another goal of this research study is to learn more about how tivozanib alone and the~     combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the~     research study we will perform blood tests to measure the level of substances in the blood~     such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib~     and gemcitabine.~   "
93434|NCT01834170|"~     Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause~     of cancer death. The only effective treatment for pancreatic cancer includes surgery.~     However, only 20% of the patients have surgically treatable disease. Also, the 5-year~     survival for the surgically treated patients is only 15%.~      About 40% of the patients present with advanced disease with distant metastasis, and the~     remaining 40% present with locally advanced unresectable cancer with the tumor invaded into~     surrounding major vessels. For those with locally advanced disease, systemic chemotherapy~     with or without radiotherapy provides palliation of the symptoms but cannot cure the~     disorder. Systemic chemotherapy is given through peripheral vessels.~      The investigators hypothesized that direct injection of the chemotherapeutic drug into the~     tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with~     locally advanced pancreatic cancer.~   "
93435|NCT01834157|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis,~     calcinosis and flexion contractures, the presence of hand arthritis is a major contributor~     to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in~     other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate~     mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently~     hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical~     disease activity index) is validated in rheumatoid arthritis, and may be useful for~     SSc-related arthritis, too.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis. Aim of this~     observational trial is to:~        -  investigate the efficacy and safety of different treatments on hand dysfunction in~          systemic sclerosis patients with hand arthritis and~        -  to validate the CDAI for arthritis in systemic sclerosis.~   "
93454|NCT01833910|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) can double a victims chance of~     survival from cardiac arrest (CA), yet it is provided in less than 1/3 of witnessed events.~     Studies indicate that video-based education methods can effectively train bystanders in CPR.~     Using the education and evaluation methods of an existing in-hospital training program, the~     investigators will assess the CPR skills of students taught with video-only methods, with~     and without psychomotor skills practice, and compare them to those using a video~     self-instruction (VSI) kit.~   "
93455|NCT01833897|"~     The purpose of this study is to test whether ketamine and D-cycloserine can be safely and~     effectively used for the treatment of depression. The investigators hypothesize that~     ketamine will serve as a rapid acting and safe antidepressant in patients with bipolar~     depression, and furthermore, that D-cycloserine will serve as an effective therapy following~     ketamine treatment.~   "
93489|NCT01833455|"~     The purpose of this study is to determine if reduction in premature ventricular contraction~     (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma~     catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC~     suppression in a randomized, double-blinded, crossover fashion.~   "
93436|NCT01834144|"~     Background/Justification: Regular physical activity (PA) has substantial health benefits in~     persons with type 1 diabetes (T1D), including reduced risk of complications and~     cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly~     less active than their peers without diabetes. Two major factors likely explain the low~     rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly~     nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for~     achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated~     that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e.~     walking) PA sessions may overcome these limitations. No studies have tested the efficacy of~     high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic~     variability in a randomized controlled trial (RCT).~      Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the~     hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate~     intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period~     following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate~     intensity PA intervention will elicit significant improvements in glycemic excursions, as~     measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period~     following exercise.We are also exploring the hypothesis that reducing the risk of~     hypoglycemia will lead to a sustained increase in physical activity one year after~     randomization.~   "
93437|NCT01834131|"~     The objective of this cluster randomized trial is to test whether a comprehensive~     intervention program within a national public primary care system will improve hypertension~     control among uninsured hypertensive patients and their families in Argentina.~   "
93438|NCT01834118|"~     The purpose of this study is to determine the effect of repeated renal denervation in~     non-responding patients with severe hypertension. Therefore ultrasound technique will be~     used.~   "
93439|NCT01834105|"~     This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and~     protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between~     CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe~     the mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of~     JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the~     Liuwei Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei~     Dihuang Pills to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify~     the POP kidney Yin deficiency molecular mechanism.~   "
93440|NCT01834092|"~     The investigators want to measure the degradation of the endothelial glycocalyx before and~     after clamping the aorta, in patients operated for a abdominal aortic aneurism.~   "
93441|NCT01834079|"~     This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow~     derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted~     for 36 months in patients with optic nerve diseases.~   "
93442|NCT01834066|"~     This Study is single arm, single centre trial to check the safety and efficacy of Bone~     Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular~     Dystrophy.~   "
93443|NCT01834053|"~     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone~     Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be~     conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure~     are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and~     Uncontrollable Movements called Chorea.~   "
93444|NCT01834040|"~     This Study is single arm, single center trial to check the safety and efficacy of BMMNC (100~     million per dose) for the patient with Duchenne Muscular Dystrophy,~   "
93445|NCT01834027|"~     The purpose of this study is to investigate the effects of music on patients after surgery~     in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant~     emotional stress and anxiety which can include discomfort or pain. Music therapy has proven~     to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing~     effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has~     been shown that classical music can cause physiological and psychological differences in~     patient outcomes, but few studies have looked specifically at effects of jazz music. Some~     have argued that jazz may be too involved to provide the same relaxed state as classical~     music, but this may be due in part to the type of jazz played for the patient. It is our~     hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana~     Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU~     following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the~     control group. Jazz music or no music will be played through headphones to participants in~     the study post-surgically while they are in the PACU and measures of stress, anxiety, and~     pain will be monitored.~   "
93446|NCT01834014|"~     The correlation between the values of angiogenesis-related growth factors in plasma and~     efficacy, and biomarkers relevant as prognostic factors or predictive factors for~     sensitivity or resistance to treatment will be examined exploratively.~   "
93447|NCT01834001|"~     Background:~      - Radiation is a common treatment for prostate cancer. It helps damage tumor cells and~     causes them to die. Radiation can be effective, but some tumors may be harder to treat with~     radiation or even with surgery. This happens to a small number of men who have either~     radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do~     not know if the tumor has recurred only in the prostate or has spread to another area. Also,~     men whose prostate cancer has recurred only after radiation may have different treatment~     options. This study will use improved imaging studies to better understand why some men do~     not respond as well to initial radiation treatments.~      Objectives:~      - To use detailed imaging studies to look at the results of local radiation therapy for~     prostate cancer.~      Eligibility:~        -  Men at least 18 years of age who are scheduled to have radiation for prostate cancer.~        -  Men at least 18 years of age whose prostate cancer has returned after earlier~          treatments.~      Design:~        -  All participants will have a medical history and physical exam. Blood and urine samples~          will be collected. Imaging studies will be used to evaluate the cancer at the start of~          the study.~        -  All participants will have an initial full magnetic resonance imaging (MRI) scan of the~          prostate. Tumor and healthy tissue samples will be collected.~        -  Those whose cancer has recurred after treatment will discuss possible treatment options~          with the study doctors.~        -  Participants who are scheduled to have radiation will have radiation therapy. This will~          be given according to the current standard of treatment.~        -  After radiation, participants will have regular follow-up tests and imaging studies.~          They will have another full MRI scan 6 months after the end of radiation treatment.~   "
93448|NCT01833988|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improved glycemic control vs. usual~     care for young people with type 1 diabetes 12-20 in a diabetes camp environment.~   "
93456|NCT01833884|"~     More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional~     polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless,~     some patients relapse and others are resistant to any treatment. These patients represent~     2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on~     clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International~     Prognostic Score) cannot always detect patients at risk.~      New prognostic factors are required to screen out these high risk patients. Among available~     biological factors, we will retain the cytokines secreted by tumor cells and cells from the~     environment.~      Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has~     recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index~     based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team~     published the prognostic value of the decrease of TARC (CC Thymus and Activation-related~     chemokine).~      In daily practice, the early assessment of response by PET CT-scan is now an undeniable~     prognostic factor. Early identification of no-response or relapse is, in fact, based on~     clinical and imaging (PET-CT scan).~      We propose to evaluate the decrease of cytokines concentration with a prognostic value~     (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early~     follow-up. The dosage of these cytokines will be paired with radiological assessments.~      A correlation between the decrease of cytokines plasma levels overtime and event-free~     survival will be searched afterwards.~   "
93457|NCT01833871|"~     Colour Doppler sonography has also been evaluated in differentiating adenomyosis from~     fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases~     had vessel distributions different from those found in leiomyoma cases, in addition to a~     high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or~     intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding~     vessels.~   "
93458|NCT01833858|"~     A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a~     source of LH (luteinizing hormone) in the late follicular phase .~      This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk~     of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte~     maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other~     benefits of this regimen.~      HCG might also affect endometrial function, stimulate endometrial growth and maturation and~     enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These~     results could lengthen the implantation Window.~      Inhibin A is a heterodimer protein and does not begin to increase until just after the~     increase in oestradiol in the late follicular phase, suggesting secretion by the dominant~     follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine~     action on oocyte maturation. Moreover, it is related to follicular development and size,~     serving as a marker of follicular maturation after IVF cycles .However, the role of hCG~     supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate~     and more studies is needed. Thus, the objective of this trial was to investigate whether LH~     activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist~     cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.~   "
93459|NCT01833845|"~     Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed~     study design consists of two treatment periods and one treatment arm. Treatment Period 1~     involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period~     2 involves administration of up to 16 weeks combination therapy with RBV plus HCQ.~   "
93460|NCT01833832|"~     Background:~      - Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who~     develop this disease live more than 5 years after being diagnosed. Those whose tumors have~     spread inside their abdomen may have an especially poor outcome. In these cases, traditional~     chemotherapy is not very effective. One possible new treatment is aggressive surgery with~     heated chemotherapy. This type of treatment has been more effective for other types of~     cancer in the abdomen. Researchers want to see this if approach can improve the outcomes of~     people with ACC.~      Objectives:~      - To test the safety and effectiveness of surgery and heated chemotherapy for ACC.~      Eligibility:~      - Individuals at least 18 years of age who have advanced ACC.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Heart function tests will be given. Imaging studies will be used to~          locate the surgical sites before the operation.~        -  Participants will have surgery to remove ACC tumor tissue. After the tumors have been~          removed, they will have heated chemotherapy with cisplatin. The heat may help weaken~          any remaining cancer cells and make them easier to destroy. It will also focus the~          treatment on the tumor sites, rather than the whole body.~        -  Participants will recover in the hospital for several days after surgery. They will~          have regular follow-up visits to monitor the outcome of the surgery.~   "
93461|NCT01833819|"~     Opioids may attenuate postoperative hyperalgesia and postoperative nausea and vomiting. Our~     hypothesis is: opioid-free total intravenous anesthesia with propofol, dexmedetomidine and~     lidocaine infusions for laparoscopic cholecystectomy may achieve comparable hemodynamic~     stability during laparoscopy, with lower postoperative analgesic consumption and incidence~     of postoperative nausea and vomiting.~   "
93462|NCT01833806|"~     The study hypotheses is that the proportion of patients experiencing clinically significant~     pain relief will be at least 30% greater than the proportion experiencing worsening pain.~   "
93463|NCT01833793|"~     MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study~     is to describe the acceptability of Amenorrhea in contraception indication of Mirena users~     during one year follow up in medical practice. 500 patients in 20 centers will be enrolled~     in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will~     be evaluated.~   "
93464|NCT01833780|"~     Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS)~     test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.~      The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to~     intrapartum PCR GBS and GBS cultures status.~      The larger perspective of this trial is to check the possibility of replacing the GBS~     culture screening program at 35-37 weeks gestation with a more accurate examination (PCR),~     avoiding the changing GBS carriage status from the time of culture at 35-37 weeks to~     delivery.~   "
93466|NCT01833754|"~     This is an open-label, single-dose, parallel-group study conducted in healthy subjects and~     subjects with stage 4 renal impairment (RI) or end stage renal disease (ESRD) requiring~     hemodialysis to evaluate the safety, tolerability, and immunogenicity profile of~     romosozumab. Subjects will enroll in parallel into 1 of three treatment groups to receive a~     single dose of romosozumab.~   "
93467|NCT01833741|"~     This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated~     intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension~     (OHT) in a clinical setting.~   "
93468|NCT01833728|"~     The multimodal analgesia for postoperative pain aims for optimal analgesia through additive~     or synergic drug effects. The multimodal analgesia results in the use of smaller doses of~     opioids and lowering opioid-related side effects.~      Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug~     of acetaminophen), nefopam are often given along with opioids as part of multimodal~     analgesia after major surgery.~      NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side~     effects.~      In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be~     safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not~     alter renal function or cause hemorrhagic complications.~      Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous~     acetaminophen) associated with the analgesic effectiveness of nefopam could explain the~     observed synergy of the combination.~      The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and~     analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and~     propacetamol in patients undergoing laparoscopic nephrectomy.~   "
93469|NCT01833715|"~     The aim of this study is to compare the efficacy of methadone versus morphine in dealing~     with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia~     (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as~     rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than~     morphine for postoperative pain treatment.~   "
93470|NCT01833702|"~     The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or~     older who have access to a smartphone or tablet with Internet access daily.~      The study will evaluate patient-reported comfort level with using a mobile device to record~     their pain levels, as well as adherence to recording these levels daily.~      The study will track patients' assessment of their pain, actions taken, and outcomes related~     to pain management and provider involvement.~      This study will attempt to collect information about differences in the use of two~     traditional pain assessment modes (verbal scale and paper) versus the use of a pain~     assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an~     Android or iOS operating system.~   "
93471|NCT01833689|"~     The objective of this study is to assess the effect that dietary carbohydrates have on blood~     sugar by measuring the glycaemic index. The glycaemic index is a comparison between the~     effect of equal amounts of carbohydrate from a test food compared to a standard (in this~     case glucose) on blood sugar.~      Different foods that contain different carbohydrates have different effects on blood sugars.~     This is of interest as a number of studies have shown that the level of sugar in the blood~     after a meal relates directly to the risk of developing heart disease and diabetes. The aim~     of collecting this data is to be able to give advice to people about the carbohydrates they~     eat to reduce the risk of diabetes and heart disease.~   "
93472|NCT01833676|"~     Anaesthesia and surgery has become more common in the elderly as the population survives~     longer. Anaesthesia in the elderly confers a higher risk which is related to the aging~     process and the diseases that accompany seniority. As such, there is a need to provide~     optimal anaesthetic management in order to minimize complications and risks perioperatively.~     One of the changes associated with ageing is the progressive decrease in protective~     laryngeal reflexes. Any depression of upper airway reflexes increases the chance of~     pulmonary aspiration and compromises the maintenance of the airway.~      Desflurane is an inhalational agent strongly favored due to its lower solubility in blood,~     lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly~     eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more~     rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general~     anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of~     inhalational agent itself can influence the return of protective airway reflexes. In the~     study, the inhalational agent sevoflurane was found to cause significant impairment of~     swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on~     the general population. As such, the purpose of this study is to determine whether the~     choice of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on~     the return of protective airway reflexes in the geriatric population in Malaysia, and~     whether the significance is greater in the elderly population.~   "
93473|NCT01833663|"~     This study is a multi-site, randomized, opened and parallel-controlled clinical study.~      The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate~     Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks.~     Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and~     various indices are evaluated.~   "
93474|NCT01833650|"~     The purpose of this study is to determine whether the use of honey mouthwashes in the~     prevention of salivary side effects of 131I (radioiodine) therapy.~   "
93475|NCT01833637|"~     The purpose of this study is to assess whether using computerized screening questions can~     improve how well we manage symptoms related to cancer and cancer treatments. Advance care~     planning is a process in which teams of experts assist in with treatment plans, managing~     pain and other symptoms, emotional issues, and end of life issues. With advances in~     technology, it is now possible to get the patient's feedback directly and more often. It is~     thought that repeated questionnaires completed by the patient will provide a better and more~     accurate measure of the patient's needs and experiences but this has not been tested. This~     study is designed to learn if using a computerized assessment repeatedly is better than~     standard planning techniques.~   "
93490|NCT01833442|"~     The trial objective is to compare two very different meditation protocols (Kundalini Yoga~     and Relaxation Response meditation techniques) to help the OCD treatment.~   "
93491|NCT01833429|"~     The contribution of this study is the unedited evaluation of the circadian autonomic~     profiles of resistant hypertension with and without white-coat response.~   "
93476|NCT01833624|"~     An early and efficient enteral nutritional support could improve the clinical outcomes of~     brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an~     increased gastric residual volume frequently occurs in these patients.~      Previous experimental studies have suggested that a small-peptide enteral feeding formula~     could promote the gastric emptying compared to a whole-protein formula. An improved~     gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily~     caloric intake and enhance nutritional support of brain injured critically ill patients.~   "
93477|NCT01833611|"~     Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication,~     histology improvement as well as low rate of emergence of resistant mutants. Out of range of~     clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers~     with persistently normal ALT and viral load more than 10^5 copies/mL have progression of~     liver disease during long-term follow-up. In addition, certain proportions of these patients~     do have significant inflammation and fibrosis in liver histology. This study will be able to~     identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding~     improvement of liver histology during short-term (1-year) and long-term ETV treatment~     (3-year).~   "
93478|NCT01833598|"~     Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a~     person's ability to perform daily activities and recreation. Traditional conservative~     treatments include activity modification, exercises, ice/heat, and medications and~     corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which~     the affected area is repetitively needled to disrupt pathological tissue and induce~     bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing~     capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are~     injected into the affected area, also activating growth factors. There has been promising~     research in these tendinopathy treatments but more research is needed.~      The investigators plan to expand on prior studies to identify a reproducible and efficacious~     treatment for chronic tendinopathy to reduce pain and improve function and quality of life.~     Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT~     with peritendinous PRP as a treatment for chronic tendinopathy.~   "
93479|NCT01833585|"~     The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized~     autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with~     critical limb ischemia.~   "
93480|NCT01833572|"~     This is an open-label, single-arm, phase II interventional clinical trial. The investigators~     hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a~     neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating~     (19/21) mutations will be eligible to be enrolled. EGFR mutation will be prospectively~     tested in all the participants' biopsy samples and confirmed in surgical resected samples.~     Eligible patients will be given gefitinib 250mg for 42days followed with surgical resection~     of tumor. Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR),~     pathologic (pathologic response), surgical (complete resection) evaluations, and safety is~     based on adverse effect evaluations.~   "
93481|NCT01833559|"~     The study is to investigate the impact of blood glucose management at the first trimester of~     pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic~     disorder.~   "
93482|NCT01833546|"~     This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy~     in subjects with solid tumors and in combination with gemcitabine in subjects with~     pancreatic cancer.~   "
93483|NCT01833533|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without~     cirrhosis.~   "
93484|NCT01833520|"~     The goal of this clinical research study is to find the highest tolerable dose of radium-223~     dichloride that can be given to patients with osteosarcoma.~      Radium-223 chloride is designed to work like radiation therapy in cells that are actively~     making bone. It is designed to target new bone growth in and around bone cancer and may kill~     cancer cells.~   "
93485|NCT01833507|"~     Obesity is common in adults with complex medical problems with ensuing complications~     afterwards. Obese patients suffer higher mortality and impaired functional status often as a~     result of their obesity. One primary goal to reduce both obesity and improve functional~     status is exercise. The investigators hypothesize that a simple exercise intervention with~     limited behavioral goal-setting will reduce weight and increase functional status compared~     to usual care. As a secondary measure, the investigators hypothesize that using this~     intervention will reduce hospital admissions and ER visits.~   "
93486|NCT01833494|"~     The purpose of this study is to investigate the safety and efficacy for 52-week dosing in~     hemodialysis patients with hyperphosphatemia.~   "
93487|NCT01833481|"~     In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total~     Hip Arthroplasties (THA), it was determined that the investigators could simultaneously~     capture in vivo sound and motion of the femoral head within the acetabular cup during~     weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP),~     metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply~     sound analysis as an impulse excitation technique for testing hip conditions and for~     measuring femoral head sliding in the acetabular component of human hip joints by acoustic~     means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and~     sound for subjects implanted using various surgical approaches. It could be hypothesized~     that subjects having various surgical approaches could lead to an increase or reduction of~     in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30~     subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or~     posterior-lateral (10 patients) surgical approach to determine if any of these surgical~     approaches leads to less or more in vivo hip separation. All subjects will be analyzed under~     in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.~   "
95135|NCT01811875|"~     Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma~     inhibitor levels for at least 100 Exposure Days (EDs) for each subject.~      Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and~     adverse events~   "
93492|NCT01833416|"~     Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased~     substantially over the past years, several issues still deserve further investigation. The~     epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive~     strategies currently used and growing and widespread use of prophylaxis. The knowledge of~     the CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among~     renal transplant recipients not receiving any prophylactic therapy will allow the~     determination of risk factors for and the impact of earlier intervention on CMV infection~     and disease. The goal is to ultimately improve the clinical outcomes for renal transplant~     recipients.~   "
93493|NCT01833403|"~     This is a pilot study to show that it is possible to identify the specific types of fats in~     blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these~     fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver~     disease is the accumulation of fat in the liver of people who have minimal alcohol exposure.~     Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and~     predicts development of Type 2 Diabetes. The study doctors are interested in looking at the~     relationship between liver fat and insulin resistance.~   "
93494|NCT01833390|"~     The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical~     imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.~   "
93495|NCT01833377|"~     This study aims to investigate the applicability of caraway (black cumin) intake on the~     treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted~     to examine the applicability of caraway product in terms of safety and efficacy.~   "
93496|NCT01833364|"~     By doing this study, the investigators hope to learn provide safety data that can be used to~     generate a larger phase III clinical trial. If successful, it would promote the development~     of a new treatment for PD in which patients are able to provide their own tissue as a source~     of a supportive environment for the injured and dying cells and thereby possibly stopping~     the progression of the illness or even improve the symptoms of PD.~      The purpose of this research is to gather information on the safety and feasibility of nerve~     graft implantation is. The results of this study will be shared with the University of~     Kentucky, Center for Clinical and Translational Science (group providing financial support~     for the study) and other federal agencies, if required.~      The overall goal of this research is to develop a novel, regenerative treatment strategy for~     idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to~     patients.~   "
93497|NCT01833351|"~     This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of~     escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by~     evaluation in oncology subjects. The study will be conducted in the Program in Integrative~     Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the~     Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy,~     Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from~     the NIH, and FDA.~   "
93498|NCT01833338|"~     The accuracy of coronary plaque characterization with Multi-slice computed tomography as~     compared to intravascular ultrasound and optical coherence tomography will be investigated~     in patients presenting with acute coronary syndrome without ST-elevation.~   "
93499|NCT01833325|"~     This is a pilot study to determine if proton radiation therapy can provide effective and~     safe treatment for subfoveal neovascularization membrane (SNVM). The study will include~     adult patients over the age of 50 with macular degeneration, who have subfoveal~     neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis.~     Additional purposes of this study are to see if the growth of neovascular membranes can be~     stopped and overall vision improved with the use of protons and assess the side effects~     associated with this treatment.~   "
93500|NCT01833312|"~     The purpose of this study is to determine if systemic cooling to a target temperature of 34~     to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves~     functional outcome at 3 months in patients with acute ischaemic stroke.~   "
93501|NCT01833299|"~     Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent~     cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment~     modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines~     for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver~     function . Unfortunately, only 10%-30% of HCCs are amenable to such curative surgical~     resection at the time of diagnosis, because of tumor multifocality, portal vein invasion,~     and underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization~     (TACE) has become the most popular modality for palliative treatment for the other patients.~     However, the long term outcomes were generally poor for HCC patients treated with TACE.~      Recently, sorafenib has shown some promises in improvement of 3-month survival among~     patients with advanced HCC. It is claimed that sorafenib has become the standard of care for~     patients advanced HCC.~      Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib~     combined with TACE with that of TACE alone in the treatment of unresectable HCC .~   "
93517|NCT01833091|"~     Effects of creating an artificial night on physiological changes, weight and feeding~     tolerance in preterm infants.~      Introduction:Nowdays,with medical advances in intensive care increased chance of survival in~     premature infants.One of the major concerns exposure to high light levels in neonate &~     subsequent it is increase in metabolism rate.So,this study was conducted to determine the~     effect of creating an artificial night on physiological changes, weight and feeding~     tolerance in preterm infants.~      Methods: This is a randomized clinical trial dual group study, 38 preterm infants~     (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated~     within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on~     the weight and the weight of each group were randomized into artificial night(dark period~     was from 19 to 7 during incubator was covered with linen cloth & light period was from 7 to~     19 removed the cover) and control groups(continuous lighting). Mothers & infants through~     questionnaires,interviews,observation & document completion, changes in physiologic & weight~     befor entering the study & then physiologic changes twice a day,weight & feeding tolerance~     were collected daily.Data were analyzed using spss v.16 software.~   "
93502|NCT01833286|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence~     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5~     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC~     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival~     after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out~     only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the~     poor functional liver reserve or because of widespread intrahepatic recurrence. In the past~     two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment~     modality and has attracted great interest because of its effectiveness and safety for small~     HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported~     a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is~     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors~     are usually detected when they are small and PRFA causes the least deterioration of liver~     function in the patients. Our previous retrospective study demonstrated that RFA was~     comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined~     with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with~     TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective~     study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after~     partial hepatectomy.~   "
93503|NCT01833273|"~     In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a~     population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the~     investigators will conduct an open-label, prospective, un-blinded study. The investigators~     expect that at least 70% of subjects will tolerate the supplement and complete the trial.~     The investigators expect no Serious Adverse Event to occur during this trial which is~     attributable to study compound. During this study, the investigators will also collect other~     qualitative data to be utilized for future double-blinded studies which will be aimed at~     determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better~     quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients~     who do not receive PolyMVA.~   "
93504|NCT01833260|"~     The aim of this study was to evaluate the effect of listening to ambient music on the~     perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary~     disease patients.~   "
93505|NCT01833247|"~     This project looks at the time course of lactic acid rise (if any) after seizures. Salivary~     and capillary lactic acid are tested. This type of measurement may be useful in signalling~     the occurrence or recent history of a seizure.~   "
93506|NCT01833234|"~     The investigators are developing a questionnaire that can quickly measure the impact that~     epilepsy has on a person's life. This questionnaire will be useful in following whether the~     impact of epilepsy increases, decreases or stays the same over time. The results also may~     point out areas that would benefit from discussion or attention in visits with your doctor.~   "
93507|NCT01833221|"~     The purpose of this study is to determine the physiology of nerve healing and the~     neurotization of the facial muscles after lengthening temporalis myoplasty.~   "
93508|NCT01833208|"~     This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of~     Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for~     treatment with Sipuleucel-T and who have bone metastases are eligible.~   "
93509|NCT01833195|"~     The objective of this registry is to observe short and long term clinical outcomes in heart~     transplant recipients who receive regular AlloMap testing as part of allograft rejection~     surveillance.~   "
93510|NCT01833182|"~     Phase 1 of the study:~      Falls are the leading cause of preventable injury, long term disability, premature~     institutionalization and mortality in the older adult population. Promising preliminary~     research suggests that modifications to the home can potentially reduce the incidence of~     falls in the elderly. The purpose of this study is to gather data necessary to design a~     definitive trial of a home modification intervention for older adults at risk for fall. The~     specific aims are to 1) estimate the efficacy of an intensive tailored environmental~     intervention to reduce functional decline among community-dwelling older adults; 2) gather~     the data necessary to design a definitive clinical trial of an intensive tailored~     environmental intervention to reduce the cumulative incidence of falls among~     community-dwelling older adults; 3) examine the direct cost of intensive tailored home~     modification. A pilot randomized controlled trial will be conducted with 40 older adults who~     have experienced a fall resulting in an emergency room visit.~      Phase 2 of the study:~      Our long-term objective is to prevent falls for these older adults at high risk by removing~     hazards in their homes. Development of an effective intervention for fall reduction could~     have an immediate impact for this population and high public health significance. Intensive~     home hazard removal has been established as an effective environmental intervention for the~     prevention of falls; however, none of the published studies have been conducted in the US,~     and no study has adequately controlled for biases. The investigators propose a~     double-blinded, randomized sham-controlled clinical trial to determine the efficacy of an~     intensive tailored home hazard removal intervention to reduce the cumulative incidence of~     falls among 110 community-dwelling older adults who visit the emergency department (ED)~     because of a fall. This three year study will be the first to utilize a sham control group~     and a double-blind, randomized study design. The investigators will intervene with a~     high-risk group of community-dwelling older adults who visit an ED after a fall. The primary~     hypothesis will be tested by comparing the 12-month cumulative incidence of falls in an~     intensive tailored home intervention group with falls in a sham control group. Falls will be~     operationalized as unintentional movements to the floor, ground or object below knee level.~     The secondary hypothesis will be tested by comparing total number of falls, number of~     injurious falls, fear of falling and performance in daily activities between the~     intervention and sham control group.~      The primary aim of the proposed study is to:~        1. Compare the efficacy of an intensive tailored home hazard reduction intervention to~          sham treatment on the cumulative incidence of falls over 12 months for older adults who~          visit the ED after a fall.~           Hypothesis 1: The cumulative incidence of falls over 12 months will be lower for the~          intensive tailored home hazard removal group compared to the sham control group.~           The secondary aims of the proposed study are to:~        2. Determine if intensive tailored home hazard reduction intervention is superior to sham~          treatment on secondary outcomes including: total number of falls, number of injurious~          falls, fear of falling and activities of daily living (ADL) performance.~           Hypothesis 2: The investigators hypothesize that the intensive tailored home hazard~          reduction intervention group will experience fewer total falls, fewer injurious falls,~          less fear of falling and improved ADL performance compared to the sham control group.~        3. Characterize intensive tailored home hazard reduction interventions including the~          frequency of environmental modification by type and location in the home and its direct~          costs. The investigators will also conduct subgroup analysis of type, location and cost~          of home modifications by race and gender.~      The proposed study is innovative because it provides intensive, individualized prescriptions~     of home hazard removal and because it provides a quick response to a fall. It is also the~     first double-blind trial of the effect of environmental modification on falls and, to our~     knowledge, is the first collaboration between occupational therapy and emergency medicine on~     fall reduction strategies in the US.~      The results of the proposed study will provide new evidence about the effectiveness of~     intensive tailored home hazard removal to reduce falls. This study has the potential to~     provide public health guidelines for the delivery of home hazard removal, decrease the~     health care costs associated with falls and to provide evidence for guiding public health~     policy for older adults who have fallen.~   "
93511|NCT01833169|"~     The purpose of this signal seeking study is to determine whether treatment with BKM120~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
93512|NCT01833156|"~     In lymphedema there is increase in water content of the tissue. We studied a device~     (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the~     apparatus is commercially available, no validation study had been performed in vivo with~     local edema.~      We designed a validation study for inter- and intra observer variability and the~     reproducibility in vivo by histamin induced local edema~   "
93513|NCT01833143|"~     The purpose of this study is to test the drug Bortezomib to see how well it works. The~     investigators want to find out what effects, good or bad, it has on patients with a limited~     smoking history or who have a specific mutation associated with their lung cancer.~   "
93514|NCT01833130|"~     This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I)~     Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA~     (BOTOX®) in adults with chronic migraine.~   "
93515|NCT01833117|"~     The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the~     integrity of tear film in adults with a history of dry eye in both eyes.~   "
93516|NCT01833104|"~     The purpose of the study is to look at the long term effects of a complex socio-affective~     mental training program on a neuroscientific-, hormonal-, behavioral-, biological, and~     subjective measures-level. The training protocol consists of a variety of meditation and~     other mental health techniques, which are trained over the period of 3-9 months (13 weeks~     per Module; 1-3 Modules)~   "
93518|NCT01833078|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in~     the brain. The investigators already know that a single dose of Ghrelin improves food intake~     immediately after the dose in frail older people. In this study, the investigators are~     trying to find out if repeated daily doses of ghrelin will help frail older people improve~     food intake for multiple days in a row.~   "
93519|NCT01833065|"~     12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with~     Chronic Idiopathic Constipation.~   "
93520|NCT01833052|"~     This prospective, randomized study was designed to investigate the benefit of using a~     Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic~     valve implantation (TAVI) with a Medtronic CoreValve®.~   "
93522|NCT01833026|"~     Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease~     that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be~     managed when diagnosed and proper medical care is provided.~      The purpose of this study is to determine if diagnosis and guided therapy with the use of~     spirometry is related to better patient outcomes (the condition of a patient's health)~     compared to usual care which may or may not include the use of spirometry. Spirometry is a~     standardized test used in medical practice that measures how much air your lungs can hold~     and how forcefully you can breathe out.~      For this study, the investigators will compare two groups: 1) intervention (treatment) group~     and 2) usual care group (control). The intervention group will have a spirometry test and~     the results will be provided to the primary care physician. The usual care group will not~     initially have a spirometry test. Both groups will be followed for outcomes.~   "
93523|NCT01833013|"~     Nowadays, one in six couples consults for fertility problems. If the standard examination~     and tests do not reveal any cause of infertility, the woman may undergo a laparoscopic~     exploration which reveals endometriosis in more than 50% of cases.~      Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out~     of the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic~     burden (22 billion dollars in 2002 in the USA) and important decrease in quality of life.~     Physiopathological mechanisms and risk factors for endometriosis are not well identified.~      A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a~     25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of~     endometriosis.~      There are many manifestations of this disease (infertility, pelvic pain) and the~     anatomo-clinical correlation is not good. The presently used international classification~     (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy.~     New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but~     need to be validated. Treatment for endometriosis-related infertility is not consensual.~      A prospective cohort study would give access to clinical data of patients followed in our~     center, so as to identify clinical factors predicting pregnancy and to help treatment~     decision for women with endometriosis suffering from infertility.~   "
93524|NCT01833000|"~     The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio~     (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal~     bleeding and/or abdominal distension. CSOR will be determined using near infrared~     spectroscopy (NIRS).~   "
93525|NCT01832987|"~     Rationale:~      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real~     challenge as failure in response to treatment and serious side-effects are frequently~     encountered. New, more effective drugs with less side effects are therefore urgently needed~     to solve this problem. Although several new drugs against TB are in the pipeline, physicians~     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.~     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.~     Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be~     effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al.~      Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be~     analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is~     suitable for storage, transportation and subsequently analysis without additional cooling or~     storage requirements.~      Objective:~      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960~     mg co-trimoxazole in TB patients. This clinical trial will provide important information on~     PK of co-trimoxazole in TB patients for future studies.~      The second objective is to calculate the T>MIC and AUC0-24h/Minimal inhibitory concentration~     (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots~     will be clinically validated by comparing results of blood samples withdrawn from venous~     blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively,~     data from this study can be used for limited sampling strategies for co-trimoxazole based on~     a pharmacokinetic population model constructed from the full PK curves of the patients.~      Study design:~      A prospective pharmacokinetic study.~      Study population: 12 TB patients.~      Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal~     treatment regimen.~      Main study parameters/endpoints:~      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary~     endpoints of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio~     are most likely the best predictive parameters for efficacy of co-trimoxazole treatment and~     will be calculated for a range of M tuberculosis isolates.~   "
93526|NCT01832974|"~     IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to~     specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to~     find one that may be safe and effective against cancer that has returned, spread to other~     organs, or that cannot be surgically removed.~      Participants will receive physical exams and report side effects. Blood and urine samples~     will be collected. Imaging studies, tissue samples, and other tests will be used to study~     the tumor before the start of treatment and during the study. IL-13-PE therapy will be given~     to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.~      The study will be done in two parts, with a six-month period between them. If the cancer~     continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink~     or not grow the study will continue, even into a follow-up period after the second part of~     the study.~      The first part of this study will determine how much IL-13-PE can be tolerated. For this~     part, the study is recruiting adult patients with various types of cancer. After six~     participants have taken the lowest dose with no more than one experiencing dose-limiting~     toxicity, two participants may begin the study taking the medium dose. If they tolerate the~     medium dose for a month, up to four more may begin at that dose. When at least three~     participants have tolerated the medium dose, two may attempt the highest dose. When they~     have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study,~     receiving the highest dose.~      Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only~     1-2 people per million each year and causes hormone problems. This tumor affects children~     under age 5 and adults aged 30-40, causing death within five years for up to 80% of them.~     During the second part of the study, all participants will be ACC patients. They will~     receive the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle~     for up to four months.~   "
93527|NCT01832961|"~     Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is~     not fully reversible, and is usually progressive and associated with an abnormal~     inflammatory response of the lungs to noxious particles or gases, most commonly cigarette~     smoking. The disease affects not only the large central airways but also the small, more~     peripheral airways deeper into the lung, defined as less than 2 mm in diameter.~      Besides medical treatment, physiotherapy plays a major role in treatment and various methods~     have been suggested to remove airway of secretions. The flutter is a simple and small device~     shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency~     oscillation when the expired air passes through it. These vibrations are thought to mobilise~     airway secretions facilitating their clearance and improving breathing.~      Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have~     previously been used to investigate the efficacy of flutter devices. However, spirometry~     assesses the damage of larger airways but not small airways, also known as the silent zone~     which, crucially, are specifically damaged in COPD.~      In this study the investigators hypothesise that because the flutter helps clear the airways~     from the excessive thick mucus produced by COPD patients, these patients may find it easier~     to breathe and have lower resistance to moving air in and out of their lungs.~      The main objective of this study is to compare the effect of a flutter or a sham device on~     small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary~     to other common blowing tests, measures small airway resistance during normal breathing.~      In addition, because COPD is characterised by inflammation, the investigators would also~     like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect~     airway inflammation. This will give to investigators an insight into the relationship~     between airway inflammation and small airway function.~   "
93528|NCT01832948|"~     This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in~     untreated metastatic colorectal cancer patients, and to find the markers that may predict~     the efficacy.~   "
93529|NCT01832935|"~     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle~     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail~     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are~     generated to improve glycemic control .New insulin analogs are generated to improve glycemic~     control,However, the cost of these analogs is a major problem .The aim of this piggy back~     evaluation was to assess the effect of Glargine insuline versus NPH plus regular human~     insulin on metabolic control as well as its cost-effectiveness in people with type 2~     diabetes in the Iranian setting.~   "
93530|NCT01832922|"~     This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR)~     in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia~     (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are~     FDA approved for this indication. However, full dose bendamustine is associated with~     significant hematologic toxicity and a high rate of infectious complications in unfit~     patients and patients with significantly impaired renal function. This study will attempt to~     optimize and define adequate and safe treatment protocols for these patients with~     comorbidities and/or renal dysfunction.~      The study will accrue two independent patient cohorts which will follow a standard Phase I~     design. Patients with CLL who have significant comorbidities with or without minor renal~     dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with~     significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the~     maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.~      There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients~     will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to~     9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.~      Accrual of both patient cohorts will occur simultaneously and will take place at two~     centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI).~     Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V.~     Danilov.~   "
93531|NCT01832909|"~     The objective of this study is to measure the energy value of walnuts in the human diet and~     study molecular mechanisms that may help explain the beneficial health effects of walnuts.~     The hypothesis is that there will be less metabolizable energy in walnuts due to decreased~     fat digestibility.~   "
93532|NCT01832896|"~     The objective of this study is to evaluate the safety and tolerability of a single~     Subcutaneous (SC) dose of Ecallantide in children and adolescents with Hereditary Angioedema~     (HAE).~   "
93533|NCT01832883|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus.~   "
93534|NCT01832870|"~     This is a clinical trial designed to quantify the immune response and determine the~     tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for~     patients with advanced prostate cancer.~   "
93535|NCT01832857|"~     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients~     with advanced and/or metastatic solid tumors for whom there there is no available therapy to~     provide clinical benefit or for those who have refused further standard therapy. The primary~     outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate~     (RR), Progression-Free Survival (PFS), and safety.~   "
93536|NCT01832844|"~     The aim of this care protocol is to study the effects of scan to help epidural infiltration~     realization, in presumed difficult patients suffering from sciatica.~      These scans are already performed in our Rheumatology Department but our objective is to~     evaluate objectively its contribution for patients and doctors.~      Epidural infiltration in young patients, with an easy anatomical identification, causes~     generally no technical difficulties, therefore this protocol will only include patients~     presumed to have a difficult infiltration, that means those aged more than 60, and/or with~     BMI > 30 and/or suffering from scoliosis.~      This study concerns patients who are hospitalized in Rheumatology Department (Hospital of~     Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.~      Patient will be randomized at Day 0, before infiltration. This latter will be performed in~     accordance to current practice.~      Tolerance data (pain and satisfaction) will be collected just after the infiltration and~     eventual complications will be reported within 48 hours after infiltration.~      Following treatment of lombosciatic will be realized through hospitalization, as usual.~      Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the~     musculoskeletal clinical exam and it has already changed our rheumatology practices. The~     investigators hope at the end of this study, that results would confirm that scan can be a~     help in practice to perform epidural infiltrations.~   "
93537|NCT01832831|"~     One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to~     75% report urinary incontinence. There are many hypotheses about the exact cause of post~     prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or~     cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now~     allows three dimensional, sub-millimeter resolution of the human pelvis and clearly~     demonstrates pelvic anatomy without the distortion of dissection. It is our overarching~     hypothesis that PPI is multifactorial and occurs because of a combination of specific~     anatomical and functional impairments. We propose conducting a case control study with~     matching for age and race to compare the MRI anatomy and urinary tract function on~     urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy~     (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic~     MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral~     sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all~     believed to play a large part in continence. Multi-channel urodynamic studies will also be~     performed to assess the leak point and maximum urethral closure pressure. All cases and~     controls will complete standardized questionnaires - the AUA symptom index and the~     Incontinence Severity Index as a quality of life measure. This study is needed to provide~     critical information about causes of male PPI, a quality of life altering voiding~     dysfunction, and will assist with the advancement of pharmacological and surgical treatment~     of this disease.~   "
93538|NCT01832818|"~     The objective of this study is to evaluate long-term safety and effectiveness of the NuNec®~     Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE~     marked and commercially available in Europe.~   "
93539|NCT01832805|"~     50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be~     treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each~     stimulation day, a given patient shall receive 5 sessions with a between session delay of 10~     to 15 minutes. Patients will be selected using the structured Mini-International~     Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because~     concomitant antidepressant treatment can confound outcome results, all patients will go~     through a medication washout before entering the study and they will be free from any~     antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the~     treatment protocol. Only habitual benzodiazepine agents will be allowed.~      All patients will be closely matched for gender and age with 50 never-depressed~     medication-free healthy volunteers. Only baseline measurements will be collected: no~     volunteer will undergo the treatment.~      We expect that real Theta burst treatment and not sham will result in a significant and~     clinical meaningful response.~   "
93540|NCT01832792|"~     Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge~     eating disorder, and atypical variants of these disorders. The current study proposes to~     investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using~     a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of~     cost-effectiveness made. Results are proposed to be disseminated locally and internationally~     (through submission to conferences and peer-reviewed journals), and will hopefully inform~     local service provision.~      Please note that we are only able to offer the intervention to individuals who are currently~     registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust~     - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of~     Wiltshire.~   "
93541|NCT01832779|"~     Achalasia is a chronic disease of altered esophageal motility with resulting functional~     obstruction to the passage of food leading to poor quality of life and significant~     morbidity. The two main treatments available in the US are endoscopic balloon dilation and~     surgical myotomy. Each therapy has advantages and drawbacks and at present both are~     considered a first choice approach depending on patient preferences and local expertise.~     Surgical myotomy provides long lasting improvement in dysphagia but even when done~     laparoscopically is invasive and complex. Extensive acid reflux resulting in significant~     morbidity is routinely seen after surgical myotomy and additional anti-reflux operation is~     typically done at the time of the myotomy. Endoscopic balloon dilation is a simple minimally~     invasive outpatient procedure but improvement of symptoms tends to be shorter in duration~     and repeat dilations are commonly needed. Both therapies improve on dysphagia but tend to~     provide suboptimal control of chest pain which is one of the cardinal symptoms of achalasia.~      The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the~     suboptimal results with endoscopic balloon dilation and surgical myotomy. POEM is~     incisionless minimally invasive but in addition may have some further advantages over~     surgical myotomy including unlimited length of the myotomy with expected better control of~     chest pain and preservation of the anatomical anti-reflux barrier (angle of His and the~     cruse of the diaphragm) with expected lower incidence of acid reflux.~      In Japan POEM has become the preferred modality for therapy of achalasia due to the~     excellent results and exceptional safety record. In the US, dedicated POEM devices were~     approved by the FDA just recently. As a result the bulk of the published data comes from~     Japan and very little is known regarding outcomes in US population. Therefore the~     investigators want to prospectively record our experience with POEM as done as part of~     routine medical care in US population. This will be a data recording study. All patients~     will receive standard medical care and no experimental interventions will be performed.~   "
93542|NCT01832766|"~     Approximately 25% of people with schizophrenia abuse marijuana. These people may be using~     marijuana to self-medicate symptoms such as hallucinations (hearing or seeing things that~     are not heard or seen by others) or delusions (false beliefs i.e. people are harassing or~     persecuting them) or the depressed and anxious feelings brought on by these symptoms.~     Currently, it is unknown whether marijuana makes schizophrenia better or worse. Marijuana~     intoxication in people without schizophrenia generally causes decreased recall of words, may~     decrease reaction time and decrease inhibition. Additionally, marijuana may cause~     distractibility as demonstrated by difficulty keeping their eyes on a moving target and~     difficulty inhibiting their response to repetitive tones. However, marijuana may have~     different effects in schizophrenia. Receptors for cannabis (marijuana) are concentrated in~     the brain and maladjustment of the cannabinoid system may be associated with the difficulty~     in thinking found in schizophrenia. The proposed research project examines if clinical~     symptoms, learning, memory, inhibition and distractibility are improved or made worse by the~     acute ingestion of tetrahydrocannabinol (THC).~   "
93543|NCT01832753|"~     The purpose of this research study is to learn about the effects of treating subclinical~     hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down~     syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will~     improve cardiometabolic health and quality of life.~   "
93544|NCT01832740|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in~     young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a~     memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory~     activity typically occuring during SWS has been implicated in the consolidation effect. In~     this study we investigate if the consolidation effect can be amplified by the application of~     a weak transcranial oscillatory electric current within the frequency range of SWS in humans~     (0,7-0,8 Hz) during nocturnal SWS.~   "
93545|NCT01832727|"~     The primary objectives are as follows:~      Phase 1b:~        -  To determine the maximum tolerated dose (MTD) of oprozomib given orally, once daily, on~          2 different schedules.~        -  To evaluate safety and tolerability~      Phase 2:~        -  To estimate the overall response rate (ORR).~        -  To evaluate safety and tolerability~   "
93546|NCT01832714|"~     This study is designed to evaluate the use of a collection of tests that measure the eye~     response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The~     tests use highly precise measurement tools to assess various neurologic functions. (For~     example, high-speed cameras to record eye movement, high-end motors to precisely spin and~     move the subject, comprehensive analysis to stitch together the stimulus and the response.)~      Hypotheses:~        1. A battery of oculomotor, vestibular and reaction time tests will generate variables~          that when properly weighted and run through a given multi-variant analysis, will~          separate the subjects into one of two groups, mTBI or not-mTBI.~        2. A battery of neurologic assessment tests including reaction time, vestibular and~          oculomotor tests taxing a range of neurologic functions and executed using one or more~          of the I-Portal® family of devices, will generate responses that, when used by a~          trained physician, can aid in the diagnosis of an mTBI.~   "
95697|NCT01804543|"~     Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic~     resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS).~     Subsequent testing using these modalities will show improved oxygen to the heart muscle.~   "
93547|NCT01832701|"~     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic~     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In~     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence~     remains to be observed in vivo. The objective of this trial is to understand if regular~     (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine~     and plasma after an acute stress caused by exercise.~   "
93548|NCT01832688|"~     A national survey in Niger found that women and children are at risk of undernutrition and~     that many pregnant women don't visit health centers during pregnancy as often as is~     recommended. The aim is to assess the nutritional and health status of pregnant women in the~     Zinder region and to understand their knowledge, attitudes and practices related to health~     and nutrition during pregnancy. In collaboration with the Medical District of Zinder the~     prenatal care services will be optimized and the programmatic impact on gestational weight~     gain and anemia prevalence will be assessed.~   "
93549|NCT01832675|"~     In this project the investigators want to compare a new anaesthetic method during upper~     gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new~     method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.~   "
93550|NCT01832662|"~     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic~     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In~     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence~     remains to be observed in vivo. The objective of this trial is to understand if regular~     (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine~     and plasma. A secondary objective is to understand if polyphenols isolated from coffee may~     be as beneficial as the whole beverage in reducing oxidative stress compared to placebo~   "
93551|NCT01832649|"~     The purpose of this study is to evaluate if exercise added to usual treatment improves~     cocaine dependence treatment. The primary objective of this study is to investigate if~     exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if~     exercise can reduce negative mood states, improve quality of life and facilitate abstinence~     of cocaine.~   "
93552|NCT01832636|"~     Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea~     and undernutrition in developing countries. These include intestinal inflammation, mucosal~     damage, and alterations in intestinal barrier function that lead to malabsorption, growth~     failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea.~     Recent studies from Northeast Brazil demonstrate the benefits of a novel~     alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the~     recovery of damaged intestinal barrier function in cell culture, animal models, patients~     with AIDS, and underweight children.~      Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves~     short-term gut integrity and weight velocity 4 months after therapy in a group of~     undernourished children from Northeast Brazil. Intervention and Mechanisms of~     Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed~     to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves~     intestinal barrier function, intestinal inflammation, and nutritional status in children at~     risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln~     exerts these benefits?~   "
93553|NCT01832623|"~     Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect~     on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular~     protection).~      The link between vitamin D deficiency and osteomalacia lesions is well-known. In~     paediatrics, systematic vitamin D supplementation of infants and toddlers, associated with~     milk enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion~     was defined as the minimal concentration that enables the prevention of rickets in children~     and osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010,~     most of the international experts agreed to set minimal threshold of 25 OH vitamin D serum~     concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L)~     to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D~     insufficiency in adults. In the paediatric population, the consensus is less obvious and we~     consider that a serum concentration of minimum 20 ng/mL is necessary.~      A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and~     having a renal function normal or sub-normal, demonstrated an important prevalence of~     vitamin D deficiency (75%) in adolescents and pre-adolescents.~      Concurrently, the appearance of new bone imaging techniques (especially high-resolution~     peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a~     non-invasive manner.~      Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular~     system, adipose tissue) and given the proportion of French children possibly suffering from~     vitamin D deficiency, it seems urgent to actualize current recommendations regarding~     systematic supplementation in vitamin D. This transversal study on 200 healthy children and~     adolescents will allow to have an overview of vitamin D status in French healthy children~     and adolescents, studying with non-invasive, safe, reliable and innovative tools, the~     theoretical targets of vitamin D (bones, cardiovascular system and nutritional status); and~     then to lay the foundations of therapeutic trials aiming to evaluate the mode of vitamin D~     supplementation for healthy children and adolescents; while having a cohort for HR-pQCT~     measurements, that will allow us to have French reference range in a 10-17 year-old~     population, for this innovative, non-invasive and low radiation exposure technique.~   "
93554|NCT01832610|"~     Patients will be approached to participate in this PAS after the HeartWare® Ventricular~     Assist System receives PMA approval for the indicated use as a bridge to cardiac~     transplantation.~      Patients who participated in prior trials will be approached for this PAS as follows:~        -  Patients who are on continued HeartWare® System support, (original or exchange device)~        -  Patients who have been explanted for transplant or recovery and have not yet completed~          6 months of follow-up~      Patients who participated in prior trials who will not be approached to participate in this~     follow-up study include:~      • Patients who have been explanted for transplant or recovery and have completed at least 6~     months of follow-up (documented in the prior IDE trial).~      No new patients are being screened or implanted with the HeartWare® System for this trial,~     it is a follow-up trial only.~   "
93555|NCT01832597|"~     The purpose of this study is collect and evaluate the clinical experience reached in Italy~     on the use of bendamustine alone or combined with rituximab as treatment of patients with~     relapsed or refractory chronic lymphoproliferative disorders.~   "
93567|NCT01832441|"~     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone~     Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted~     for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are~     abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any~     reduction in requirement of Insulin dosage and Improvement in HbA1C Level.~   "
95698|NCT01804530|"~     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated~     dose/recommended Phase 2 dose, and efficacy of PLX7486.~   "
93556|NCT01832584|"~     This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape~     Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes.~     polyphenols have several beneficial effects on various body systems, are present in many~     edible foods, and are considered safe for human consumption by regulatory authorities.~     Animal and human studies suggest a potential for polyphenol-rich compounds in enhancing~     mitochondrial activity and exercise capacity. However, the effect of RGC on exercise~     performance in humans had not yet been tested. A special population where increasing~     performance is highly sought are competitive athletes. The aim of the current study is to~     investigate the effect of RGC on measures of aerobic fitness, body composition and mood in~     trained male cyclists~   "
93557|NCT01832571|"~     This pilot, open-label, prospective study will determine the feasibility of integrating~     pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers~     and if women who are enrolled in those programs will adhere to the daily PrEP regimen of~     Truvada®. This study will enroll 500 HIV antibody negative female sex workers in Eldoret and~     Nairobi, Kenya.~   "
93558|NCT01832558|"~     In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III~     patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per~     day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg~     (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close~     monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based~     method, quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang~     1-9, Ang 2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed~     simultaneously out of blood sera (after run-in phase and after 10 weeks).~   "
93559|NCT01832545|"~     The aim of PICO study is to design an aquatic exercise program specific for obese~     individuals with knee osteoarthritis which the main goals are OA symptoms management and the~     improvement of physical fitness. The author's opinion is that the musculoskeletal pain is~     the main constraint for any kind of mobility and its control should be considered as an~     important goal in the weight management's programs. Therefore the PICO project proposes an~     aquatic exercise program to controlling pain and other symptoms management, showing that it~     is possible to live with the disease, and motivating the change in lifestyle, thus~     preventing the installation or worsening of KOA. In this way, five hypotheses were~     formulated: H1. 3 months of aquatic exercise is enough to improve KOA symptoms and~     functionality in obese individuals; H2. The gait parameters of obese individuals with KOA~     can be improved by aquatic exercise; H3. Beyond the exercises skills, aquatic exercise group~     classes can work with an educational component, promoting lifestyles changes. H4: Pain~     reduction and a better psychological status can lead an increase of functionally, increasing~     amount of physical activity. H5: Even if the main goal is not weight management, the aquatic~     exercise program can lead a weight reduction or body composition change.~   "
93560|NCT01832532|"~     This is an open label, controlled study.~      The investigators are studying if the FDA approved diabetes medicine liraglutide (Victoza®)~     can improve sleep apnea in adults. This study is testing liraglutide in 20 adults without~     diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a~     control group of 10 adults without diabetes who have sleep apnea but will not use~     liraglutide. Both groups will continue receiving standard of care for their sleep apnea as~     prescribed by their managing sleep physician throughout their study participation.~      Everyone in the study will have two study visits and one overnight sleep study for research.~     Subjects who have not had a recent sleep study but otherwise qualify for the study, will~     have an additional research sleep study to determine the baseline severity of their sleep~     apnea. The study visits include fasting blood samples and breathing tests (pulmonary~     function test and hypercapnic challenge). There will be weekly phone visits that include a~     questionnaire on sleepiness. The group that takes liraglutide will check their blood sugar~     two times a day while on the medicine.~   "
93561|NCT01832519|"~     Our research is comparing the lungs of babies and young children with CF (cystic fibrosis)~     to those without CF. We are looking at the blood flow in the lungs to help doctors better~     understand how CF damages lungs and how to prevent this damage in the future. We will use~     MRI (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes~     in the lungs of babies and young children with CF. We will look at the special blood tests~     to see if they can work as signals for the doctors to better understand when changes are~     happening in the lungs.~      For the babies with CF, we will compare MRI images of the lungs to their CT images (also~     sometimes called CAT scans or Computerized Tomography). We hope that this study will help us~     reduce the number of X-rays and CT scans children with CF might get in the future. Because~     MRI's do not use radiation, this could reduce the amount of radiation exposure that children~     with CF would get over their lifetime.~   "
93562|NCT01832506|"~     This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of~     MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy~     or to which no effective standard therapy is applicable.~   "
93563|NCT01832493|"~     The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is~     a multicenter, prospective, non-randomized acute feasibility study that is being conducted~     to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify~     the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV)~     electrodes in patients indicated for cardiac resynchronization therapy.~   "
93564|NCT01832480|"~     The overall goal of this project is to determine the influence of patient treatment and host~     factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women~   "
93565|NCT01832467|"~     To determine the objective overall response of re-treatment with cetuximab-based~     chemotherapy in patients upon disease progression while under observation, who had~     previously responded to first-line or second-line treatment with cetuximab-based~     chemotherapy for metastatic colorectal cancer (mCRC), but had stopped treatment for reasons~     other than disease progression.~   "
93566|NCT01832454|"~     This Study is Single arm, Single Centre trail to check the safety and efficacy of bone~     marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for~     36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary~     outcome measures are improvement in walking ability and kinetic gait pattern.~   "
93570|NCT01832402|"~     The goal of this clinical research study is to learn if fentanyl nasal spray can help to~     control shortness of breath in patients who have been treated or are being treated for~     cancer.~      Fentanyl is commonly used for treatment of cancer pain. It may help patients with their~     shortness of breath as well.~      In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to~     be compared with a study drug to learn if the study drug has any real effect.~   "
93571|NCT01832389|"~     The objective of this study is to determine whether a goal-directed therapy can reduce the~     incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.~   "
93572|NCT01832376|"~     Study population: Subjects with long standing symptoms from calcific tendonitis,~     non-responsive to other forms of conservative treatment~      Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated~     by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by~     clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report~     section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be~     performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12~     months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with~     insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment~     by acromioplasty.~      Purpose of the study: The investigators want to find out~        -  if shoulder function, measured by a shoulder score, will increase during follow-up~        -  how much of the calcific material can be aspirated (in ml)~        -  to which extend the calcific deposit disappears on x-rays and sonographic images~        -  how many patients will need surgical treatment~   "
93573|NCT01832363|"~     The purpose of this study is to determine if the bronchial thermoplasty treatment can be~     guided through hyperpolarized xenon lung MRI.~   "
93574|NCT01832350|"~     The primary objective of this study is to test the hypothesis that Nuedexta (20/10)~     administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity~     (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients~     with Alzheimer's Disease (AD). The primary objective will be evaluated using a study~     endpoint at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this~     study is to evaluate the benefit of treatment with Nuedexta (20/10) on cognition and~     functionality as demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making~     A and B, Wechsler Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word~     Association (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI),~     Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the~     11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).~   "
93575|NCT01832337|"~     Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The~     investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce~     heart and gastrointestinal function injury in middle-aged and elderly patients undergoing~     elective laparoscopic colorectal surgery.~   "
93576|NCT01832324|"~     The Study examines the molecular basis of food allergy. It explores the interaction between~     T cells, InKT cells and cytokines in the development of food allergy. The study also~     explores these factors in development of tolerance outgrowing food allergy. It will also~     explore the genetic factors that lead to the development of food allergy.~      The study examines all type of food allergy including IgE mediated reactions, Eosinophilic~     Esophagitis and Food Protein Induced Enterocolitis~   "
93577|NCT01832311|"~     The purpose of this study is to compare the levels of several immunoregulatory factors in~     serums and aqueous humor of type II diabetes cataract patients with those in senile~     non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment~     in diabetic eye may contribute to an increased frequency of intraoperative and postoperative~     intraocular lens surgery complications.~   "
93578|NCT01832298|"~     RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to~     chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both~     in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on~     topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency~     and pharmacologic profiles, compared with the clinically available CPT analogues.~      PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of~     Simmitecan.~   "
93579|NCT01832285|"~     The purpose of this study is to determine effect of Fluvoxamine augmentation on cognitive~     function , aggressive behavior , clinical symptoms and mRNA (messenger ribonucleic acid) and~     protein expression in human peripheral mononuclear blood cells (PMC) in medicated~     schizophrenia patients~   "
93580|NCT01832272|"~     This study is aimed to determine the efficacy and the safety of the tourniquet reinflation~     after early tourniquet release in total knee arthroplasty, compared to the method of early~     deflation without reinflation. The investigators hypothesized that the reinflation after~     early release of the tourniquet would be effective in terms of improved visualization of the~     surgical field and decreased operation time and blood loss, whereas it would increase~     tourniquet-related complication due to longer tourniquet-use time.~   "
93581|NCT01832259|"~     The area around a tumor (pre-metastatic niche) may be an area to which cancer cells are~     attracted. The study doctor will take blood and tumor samples to look for certain features~     linked with response to treatment so that they can predict which future patients may benefit~     from this therapy. The purpose of this study is to see if the drug pazopanib can be used to~     reduce the amount of pre-metastatic niche in the patient's lymph nodes (a common site for~     prostate cancer to spread). Down the line, this may help to prevent prostate cancer from~     coming back after surgery.~   "
93582|NCT01832246|"~     The accurate prediction of depth of tumor invasion in early gastric cancer is essential for~     the proper selection of candidates for endoscopic resection. Conventional endoscopy and~     endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early~     gastric cancer. However, there has been no prospective comparative study on the accuracy~     between the 2 methods. Therefore, the investigators prospectively compare the accuracy~     between the 2 methods regarding prediction of depth of invasion.~   "
97035|NCT01786902|"~     Growth hormone therapy will improve the height of idiopathic short statured children.~     DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to~     non-treatment group in efficacy and safety.~   "
93583|NCT01832233|"~     People with hypertension are at a higher risk for cardiovascular disease and death so it is~     important to lower blood pressure to normal levels as quickly as possible. Previous research~     has established that renal nerve denervation successfully lowers blood pressure measured in~     the arm in the physician's office. This study is being conducted so that the investigators~     can determine whether renal nerve denervation also helps to lower blood pressure over 24~     hours, as well as central aortic blood pressure, which is pressure exerted by the aorta~     closer to the heart and may be a better predictor of cardiovascular problems. The~     investigators also want to know whether these beneficial effects on blood pressure can last~     up to 2 years, whether renal denervation reduces the number of medications patients need to~     take, and whether it reduces glucose and insulin levels in the blood since hypertension is~     also related to obesity and diabetes.~   "
93584|NCT01832220|"~     This project is designed to examine the interaction between the microflora in the lower~     airway and the concentration of a serum protein called alpha-1 antitrypsin. The hypothesis~     is that alpha-1 antitrypsin impacts the diversity and content of the lower airway~     microflora, resulting in a less inflammatory airway.~      The Specific Aims are:~        1. To compare the lower respiratory tract microbiome and virome population diversity and~          content in age and GOLD stage matched PiZZ individuals not receiving augmentation~          therapy, PiZZ individuals on augmentation therapy, PiMZ individuals not receiving~          augmentation therapy, and PiMM individuals with chronic obstructive pulmonary disease~          (COPD).~        2. Determine correlations between bronchoalveolar lavage (BAL) and peripheral blood gene~          expression patterns and patterns in lung microbial and viral populations across all~          cohorts.~        3. Correlate the presence or absence of computed tomography (CT) bronchiectasis and~          bronchiolectasis with patterns in the microbiome population diversity and content.~        4. To identify and define novel molecular phenotypes of Alpha-1 Antitrypsin Deficiency~          (AATD) based on computational integration of clinical, transcriptomic, and microbiome~          data.~   "
93585|NCT01832207|"~     Background The purpose of the present controlled clinical trial was to assess the effect of~     a single 60 min application of transcutaneous electrical nervous stimulation (TENS) at~     sensory stimulation threshold (STS), compared to the application of motor stimulation~     threshold (MTS) as well as to untreatment, on the surface electromyographic (sEMG) and~     kinesiographic activity of patients with temporomandibular disorder (TMD). Methods Sixty~     female subjects, selected according to the inclusion/exclusion criteria, suffering from~     unilateral TMD in remission were assigned to MTS, STS or untreatment. Pre- and~     post-treatment differences in the sEMG activity of temporalis anterior (TA), masseter (MM),~     digastric (DA) and sternocleidomastoid muscles (SCM), as well in the interocclusal distance~     (ID), within group were tested using the Wilcoxon test, while differences among groups were~     assessed by Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.~   "
93586|NCT01832194|"~     There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal~     pain that we found published. We propose a pilot study to use Botox to block the testicular~     nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical~     therapy. The men must have had temporary relief from a testicular cord block using marcaine.~     Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men~     would be asked to fill in visual analog scales for pain, a quality of life assessment, a~     depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be~     subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.~   "
93587|NCT01832181|"~     The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is~     increasing evidence that in-utero exposure to maternal diabetes is associated with an~     increased risk of obesity and type 2 diabetes in children and adults. There is an urgent~     need to reduce these increasing rates of obesity and diabetes in subsequent generations.~      The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded~     multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample~     size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin~     to a standard regimen of insulin in women with diabetes, on perinatal morbidity and~     mortality.~      The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment~     with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in~     adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2~     years of age.~   "
93588|NCT01832168|"~     The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic~     membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic~     prostatectomies.~   "
93589|NCT01832155|"~     The study hypothesized that it is feasible and safe to use Hatha yoga in older women with~     knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and~     stiffness, enhance physical function, and improve quality of sleep and quality of life in~     older women with knee OA.~   "
93590|NCT01832129|"~     In this study, biomarker response after supplementation with oral and intramuscular vitamin~     B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will~     be used to control for non compliance as a possible confounder in oral treatment.~     Additionally subjective acceptance in terms of presumed preferences will be compared with~     oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.~   "
93591|NCT01832116|"~     The purpose of this multicenter imaging sub study is to evaluate the biodistribution and~     organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or~     platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an~     antigen overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with~     89Zr-MMOT0530A, patients will be treated with DMOT4039A in the DMO4993g protocol~     (clinicaltrials.gov identifier NCT01469793) after this study. DMOT4039A is an antibody-drug~     conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl~     auristatin (MMAE). By imaging patients with the monoclonal antibody MMOT0530A before~     treatment, the correlation between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A~     therapy will be assessed.~   "
93592|NCT01832103|"~     The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of~     MK-7145 2 mg immediate release (IR) following single-dose administration in male~     participants with moderate renal insufficiency. In addition, the study will evaluate the~     pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in~     male participants with moderate renal insufficiency.~   "
93595|NCT01832051|"~     Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor~     lesions in breast cancer patients is essential for diagnostic and therapeutic management of~     metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be~     difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical~     dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack~     of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional~     information, have so far not been able to replace the biopsy. To solve this problem,~     non-invasive whole body visualization and quantification of HER2 expression by means of the~     HER2-PET may be a valuable tool.~      In this prospective multicenter imaging study, eligible patients will receive one HER2-PET~     and CTC analysis in addition to standard work up for metastatic disease. Subsequent~     administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three~     questionnaires, one before HER2-PET and two after HER2-PET.~   "
93596|NCT01832038|"~     The purpose of this trial is to evaluate the safety and tolerability of long-term~     administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with~     Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]~   "
93597|NCT01832025|"~     Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery~     procedure where bone is added to the upper jaw near the molars. The goal of the surgery is~     to add enough bone material onto the upper jaw to support the placement of a dental implant.~     The augmentation and the dental implant placement will be done at the same time to avoid the~     need for two surgeries. This is standard of care.~      The purpose of this study is to compare any problems and patient comfort levels following~     surgery. Subjects will be randomly placed into one of two groups: the internal lift group or~     the external lift group. Both types of surgery are routinely done at our clinic. Usually the~     type of procedure (internal or external) is based on the dentist's preference. Investigators~     are doing this study to compare them to each other to see if one is more comfortable for the~     subject than the other or if they are equal. It is predicted that the two techniques may~     differ when it comes to complications during the procedure, patient discomfort following the~     procedure and patient complications in the weeks and months after the procedure. This last~     comparison has not yet been studied, and surgeons often choose the technique that they~     prefer from their own experiences. With this research study researchers hope to gain~     valuable information that will help surgeons' decisions in the future.~        -  Investigators hypothesize that external sinus augmentation with simultaneous implant~          placement (external technique) will have a higher rate of Schneiderian membrane~          perforation than the internal sinus augmentation with simultaneous implant placement~          (internal technique).~        -  Investigators hypothesize that the internal technique is associated with more~          discomfort for the subject compared with the external technique.~        -  Investigators hypothesize that the external technique will result in more severe~          pain/bleeding/swelling than the internal technique.~        -  Investigators hypothesize that the internal technique has a higher incidence of~          complications that occur between three weeks and three months postoperatively compared~          with the external technique.~        -  Investigators hypothesize that the external technique has a higher amount of analgesics~          taken postoperatively compared with the internal technique~   "
93598|NCT01832012|"~     175 second year medical students were assessed on their BLS CPR skill retention after an~     approximate one year after taking the initial certification class, and the investigators~     assessed which type of refresher course would be most effective in improving the students'~     CPR skills. Group 2 had no refresher, Group 3 had a multimedia refresher, and Group 4 had~     the same multimedia refresher plus hands on practice on a Laerdal BLS manikin. The~     investigators hypothesized that Group 4 would perform CPR skills with the highest competency~     compared to the other two groups.~   "
93599|NCT01831999|"~     Building on the recent advances in telephone supported care, clinical monitoring, and~     outreach work, the specific aims of the study are to:~        1. Develop RecoveryTrack™- ExtendedCare (RT-E), a modified/new version of RecoveryTrack™.~          The investigators will adapt and finalize the original Web-based RT system, manual, and~          training to accommodate use by counselors for clients who are no longer attending~          Outpatient (OP) treatment.~        2. Conduct a pilot study to determine the preliminary efficacy of RT-E compared to~          treatment as usual (TAU) for clients entering Intensive Outpatient (IOP) substance~          abuse treatment (SAT). In this randomized clinical trial, it is hypothesized that RT-E~          will positively impact treatment attendance and substance use outcomes. In exploratory~          analyses, the investigators will also evaluate the comparative impact of RT-E versus~          TAU on HIV related client behaviors.~        3. Evaluate feasibility and counselor and client acceptability of RT-E.~        4. Conduct preliminary cost and cost effectiveness analyses comparing RT-E to TAU.~      Hypothesis 1: RT-E clients will attend more days of OP treatment than TAU clients. The~     investigators will compare the two groups on monthly treatment attendance for months 1~     through 9. We expect a main effect of group with RT-E clients displaying more attendance~     than TAU clients.~      Hypothesis 2: RT-E clients will have higher rates of abstinence than TAU clients. The~     investigators will compare abstinence rates at months 3, 6, and 9. Abstinence is a binary~     variable based on both biological test results and self-reported substance use from the~     Addiction Severity Index, Version 6 (ASI6). We expect a main effect of group with RT-E~     clients displaying higher rates of abstinence than TAU clients.~      Secondary Analyses:~      HIV Risk Scores: The investigators will compare the two groups' Risk Assessment Battery~     (RAB) HIV risk scores (i.e., total, sex, drug) at month 9.~      Use of HIV specialist services: Client attendance charts will be reviewed to compare the two~     groups on the number of times clients met with a program HIV Specialist at month 9.~      Multidimensional Outcomes: The investigators will compare RT-E and TAU clients on~     multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.~   "
93600|NCT01831986|"~     Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating~     symptoms. It was suggested that compounds with neuroprotective effects might be useful in~     the management of SZ/SA symptoms. Our previous clinical trials indicated significant~     beneficial effects for augmentations with two different neuroprotective agents: Pregnenolone~     and L-Theanine. Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on~     the central nervous system. Our recent 8-week, randomized, double-blind trial among patients~     with chronic SZ/SA disorders, in which PREG versus placebo and DHEA was added to~     antipsychotics, yielded encouraging results: PREG augmentation demonstrated significant~     amelioration of positive symptoms, EPS, as well as an improvement in attention, and working~     memory performance of SZ/SA disorder patients (Ritsner et al 2010). L-Theanine is a unique~     amino acid present almost exclusively in the tea plant. It possesses neuroprotective,~     mood-enhancing, and relaxation activities. L-theanine augmentation to antipsychotic therapy~     can ameliorate positive, activation, and anxiety symptoms in SZ/SA disorder patients (grant~     # 06TGF-911, (Ritsner et al 2010). This proposed study would extend our prior research with~     Pregnenolone and L-theanine by combining both agents versus placebo. We hypothesized that~     addition of both these compounds to ongoing antipsychotics would significantly improve the~     clinical status of SZ/SA patients.~      Methods: In an 8-week, randomized, double-blind placebo-controlled trial a combination of~     PREG (50 mg/day) with L-theanine (400 mg/day) versus placebo will be added to the stable~     ongoing antipsychotic treatment of 200 patients with schizophrenia or schizoaffective~     disorders. This trial will be conducted at five sites in Israel. Participants will be~     assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research~     instruments will be used for the assessment of psychopathology, side effects, general~     functioning and quality of life~   "
93601|NCT01831973|"~     INVESTIGATIONAL PRODUCT:~      TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.~      PHASE OF DEVELOPMENT:~      Phase II~      No. OF PATIENTS:~      Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)~      STUDY OBJECTIVES:~      Primary~      • To evaluate non-progression disease (non-PD) rate at the end of cycle 6~      Secondary~        -  To evaluate progression free survival (PFS)~        -  To evaluate overall survival (OS)~        -  To evaluate the duration of non-PD~        -  To evaluate objective response rate (ORR; where ORR= CR+PR) and duration~        -  To evaluate the safety profile of TLC388~        -  To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6~      STUDY DESIGN:~      This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388~     monotherapy in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).~   "
93602|NCT01831960|"~     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis~     suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied~     every twelve hours for two weeks, in subjects with acne vulgaris ages 12 years or older.~   "
97036|NCT01786889|"~     The purpose of this study is to test the feasibility of identifying incident cases of~     angiosarcoma of the liver from the network NetSarc.~   "
93603|NCT01831947|"~     This clinical trial investigates the impact of intravitreal injection of Ranibizumab~     antibody on the acuteness of vision. Patients included are suffering from choroidal~     neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).~      Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3~     months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second~     group is treated on demand.~      The primary end point of the study is the change of best-corrected visual acuity after 12~     month.~      Secondary end points include the impact of Ranibizumab on morphological changes of the~     retina, the number of patients with gain or loss of 15 or more letters visual acuity after~     12 months, changes in quality of life and the number of injections required during the first~     12 months of treatment.~   "
93604|NCT01831934|"~     This pilot clinical study, funded by the National Institutes of Health, will evaluate the~     safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV).~     This single arm study will consist of two cohorts: MELAS syndrome volunteers (a specific~     identified disorder of mitochondrial dysfunction: mitochondrial encephalopathy, lactic~     acidosis, and stroke-like episodes) between 13-60 years for OR adult control volunteers~     between 18-65 years of age. Both cohorts will receive the same treatment: a single~     vaccination with an FDA-licensed intramuscular seasonal trivalent inactivated influenza~     vaccine (TIV).~   "
93605|NCT01831921|"~     The investigators plan to test two different strategies for weight loss and diabetes~     prevention in the Latino community in and around Forsyth County, NC. The study is designed~     to test the hypothesis that a lifestyle weight-loss program implemented within the Latino~     community will have a more beneficial and clinically meaningful impact on HbA1c, insulin~     metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care~     condition. This lifestyle intervention will include group-based sessions promoting healthy~     eating, increased physical activity and weight loss. These sessions will be delivered by lay~     community members, known as Latino Health Advisors (LHAs). The enhanced usual care group~     will consist of individual counseling with are registered dietitian and uses existing~     community resources to assist participants in making healthier lifestyle choices.~   "
93606|NCT01831908|"~     Persons voluntarily attending the Community Center of the Atahualpa Project during one~     calendar year will be evaluated by trained personnel to check their cardiovascular health~     status. A chart with information of healthy behaviors as well as the numbers of the person's~     blood pressure, fasting glucose, and total cholesterol levels will be given. Persons who~     sign the informed consent will be visited at their homes after 3 months and than every year~     up to five years. The idea is to check whether the person followed our advises and if that~     compliance iis associated with improvement in the cardiovascular status or with a decreased~     incidence of stroke and ischemic heart disease, when compared with persons who did not~     attend the community center or those who did not follow our advices.~   "
93607|NCT01831895|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
93608|NCT01831882|"~     The primary objective of this study is to investigate the biological components of major~     depression. The investigators are particularity interested in genetic variation and how it~     contributes to cortisol (because cortisol is higher in severe depression than mild~     depression or healthy controls) and how it contributes to clinical symptoms, especially~     suicidal ideation/behavior and psychosis.~   "
93609|NCT01831869|"~     Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general~     population, especially in women older than 50 years old. It is controversial whether SCH can~     lead to increased risks of cardiovascular (CV) disease and whether treatment with~     L-thyroxine reverses these risks. The present study was designed to evaluate the effect of~     L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum~     inflammatory factors and adipocytokines.~   "
93610|NCT01831856|"~     The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal~     cardiac rhythm after direct electric cardioversion in patients with persistent atrial~     fibrillation and cardiac failure.~   "
93611|NCT01831843|"~     To evaluate differences in intraoperative body temperature between heated huimid breathing~     circuit and conventional breathing circuit~   "
93612|NCT01831830|"~     The primary objective of this study is to evaluate the preliminary effectiveness and~     acceptability of an innovative in-home nonpharmacological intervention, the Veterans'~     In-home Program (VIP), for Veterans with mild to moderate traumatic brain injury (TBI) and~     their families. VIP is designed to promote community reintegration, improve quality of life,~     and support functioning by realigning environmental demands to match the Veteran's~     abilities.~   "
93613|NCT01831817|"~     The purpose of this exploratory study is to compare the treatment effect on dentinal~     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile~     sensitivity. This proof of concept study will compare the test dentifrice with three other~     treatment groups.~   "
93614|NCT01831804|"~     This is a randomized, placebo-controlled, single-blind (subjects and investigators will be~     blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part~     B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to~     evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin)~     and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first~     single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by~     subjects at home. Part B will include approximately 3 cohorts in which the concentration of~     drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in~     Part B.~   "
93615|NCT01831791|"~     This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of~     0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia~     types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a~     Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who~     completes the full course of study treatment and the final study visit (Week 52; Visit 7)~     will be considered as study completion.~   "
93640|NCT01831466|"~     The study is beng done to test if tofacitinib ointment is safe and effective for people with~     plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied~     once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment~     used for 12 weeks will be compared to the safety and effectiveness of placebo ointment~     (vehicle) used for 12 weeks.~   "
93616|NCT01831778|"~     The Breast Cancer Surveillance Consortium (BCSC) database contains data from 1994-2009 on~     breast cancer screening, quality, and outcomes, and its main goal is to advance breast~     cancer research. This project is funded to maintain the BCSC database and share the data~     with investigators. Our objectives are to:~        -  Maintain the BCSC pooled database using secure methods that protect the confidentiality~          of women, radiologists, facilities, and BCSC registries;~        -  Encourage and facilitate sharing of BCSC research resources, and continue developing~          and implementing our communications plan to expand resource dissemination;~        -  Provide statistical and scientific expertise to researchers, distribute customized~          limited datasets, and analyze BCSC data;~        -  Develop and support a new web-based dynamic query tool and other electronic interfaces~          to efficiently share aggregated BCSC data with the public.~   "
93617|NCT01831765|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared~     to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes.~     This trial consists of two periods: a 26 week treatment period followed by a 26 week~     additional treatment period.~   "
93618|NCT01831752|"~     This study is for adults and adolescents with type 1 diabetes. The purpose of this study is~     to learn more about an investigational system to measure blood glucose. This system does not~     require blood to be drawn from the body, and it does not require a glucose sensor to be worn~     under the skin (subcutaneously). This device instead estimates blood glucose levels by~     shining infrared light on the skin and then using sophisticated statistical analysis on how~     the light bounces back or gets absorbed (spectral data). The researchers in this study will~     compare the accuracy of the new device to glucose measurement devices that are already~     approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring~     (CGM) sensors. Information learned from this study will be used in the development of tools~     for managing diabetes.~   "
93619|NCT01831739|"~     This project is designed to address the following hypothesis:~      Distinct patterns in lung microbiome are characteristic of sarcoidosis phenotypes and~     reflected in changes in systemic inflammatory responses as measured by peripheral changes in~     gene transcription.~      The Specific Aims are:~        1. To identify peripheral blood mononuclear cell (PBMC) gene expression patterns that~          characterize distinct sarcoidosis phenotypes.~        2. To determine whether patterns in the lung microbiome are associated with sarcoidosis~          severity and disease phenotypes~        3. To correlate mRNA and microRNA expression patterns in sarcoidosis affected organs with~          changes in microbiome, clinical parameters and PBMC gene expression patterns~        4. To integrate clinical, transcriptomic, and microbiome data to identify novel molecular~          phenotypes in sarcoidosis.~   "
93620|NCT01831726|"~     The purpose of this signal seeking study was to determine whether treatment with dovitinib~     (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or~     hematologic malignancies to warrant further study.~   "
93621|NCT01831713|"~     Historically, transthoracic Doppler echocardiography has been unable to provide~     interpretable data of blood flow within the lung parenchyma because of air attenuation of~     Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek~     Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary~     blood flow (PPBF) signals. The ability to non-invasively collect information regarding the~     pulmonary aspect of the cardio-pulmonary system may provide valuable information and new~     insights into the structural and functional characteristics of the lung parenchyma and~     vasculature in health and disease states.~   "
93622|NCT01831700|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
93623|NCT01831687|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to~     assess the bioequivalence between Test Product and the corresponding Reference Product under~     fed condition in healthy, adult human subjects.~   "
93624|NCT01831674|"~     The study was a randomized, open label, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed~     condition.~   "
93625|NCT01831661|"~     The study was a randomized, open label, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under~     fasting condition.~   "
93626|NCT01831648|"~     Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each~     assay gives a very different result for the same sample. As IGF-I also varies with age, it~     is necessary to establish a broad population reference values of IGF1 concentration for each~     of the IGF1 assays used in clinical practice, taking into account individual variation~     factors such as age, nutritional status and possible treatments.~      The objective of this study is to establish normative data based on a large random selection~     from the general population, including representation from all age groups (around 100~     subjects for each decade age range). This will be performed for all the available assay~     kits. Subjects with medical conditions and medications that may affect the outcome will be~     excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and~     results will be reported as mass units but also as SD scores in order to be able, in a given~     patient, to compare its IGF-I concentration along time, even if using different assays.~   "
93641|NCT01831453|"~     The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral~     aphthous ulcers~   "
93642|NCT01831440|"~     The purpose of this study is to determine the level of residual symptoms and psychosocial~     factors affecting recovery of psychosocial functions in MDD patients who reach remission,~     and investigate the recovery process of psychosocial functions.~      The investigators suppose that even the patient is well-treated by drug,there are still many~     residual symptoms,and they also exist different degree of damage in the structure and~     functions of brain. CBT could help them obtain better recovery,especially in psychosocial~     functions.~   "
93627|NCT01831635|"~     There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The~     investigators conducted a systematic review of the literature which identified several~     cohort and case-control studies that have investigated a wide range of potential medical,~     environmental and occupational risk factors. However, these studies have been limited by a~     wide variation in case definition and small sample sizes limiting the potential to detect~     modest risk differences between cases and controls. The research group propose an~     exploratory case-control study of 100 patients with classic MPNs and 200 controls to~     determine the optimal methods for roll out of this study to a multi-centred UK-based~     case-control study that will investigate the aetiology of MPN subtypes. The objectives of~     the study are to evaluate recruitment procedures, response rates, the development of a~     telephone administered questionnaire, compare occupational exposure assessment using~     OccIDEAS, a novel web based program, with a job-exposure matrix (FINJEM), evaluate the~     feasibility of collection of DNA from saliva compared to blood samples, identify potential~     aetiologic factors associated with MPNs and explore assessment of quality of life. The~     findings of this exploratory study will form the basis of a protocol for a large United~     Kingdom (UK)-wide case-control study of MPNs.~   "
93628|NCT01831622|"~     The goal of this trial is to investigate the cognitive- and brain-mechanisms underlying~     decision making (DM) and learning in young adults with Attention-Deficit/Hyperactivity~     Disorder (ADHD) as well as the modulation of task-related and task-independent brain~     activation by methylphenidate. The study aims at using a double-blinded, placebo controlled,~     cross-over, withdrawal design to study the effects of ADHD and methylphenidate in both a~     behavioural study investigating cognitive effects on decision making and instrumental~     learning, and a functional MRI (fMRI) study investigating the effects on brain mechanisms~     during decision making alone. A secondary objective of the trial is to measure the effect of~     adult ADHD and methylphenidate on cerebral perfusion. This will be done through applying a~     novel arterial spin labelling MRI-technique on the participants in the fMRI arm of the~     study.~   "
93629|NCT01831609|"~     To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary~     cultures from metastatic cancer patients. The specimens will be analyzed using~     DNA/RNA/proteomic approaches.~   "
93630|NCT01831596|"~     The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP~     Device.~   "
93631|NCT01831583|"~     The goal of this study is to collect raw waveform data for two separate noninvasive methods,~     both of which may be useful for the assessment of upper airway obstruction.~   "
93632|NCT01831570|"~     Introduction Osteoarthritis is a chronic disease characterized by a progressive degradation~     of articular cartilage. Hand OA involves symptomatically more than 1 million of subjects in~     France (i.e., painful or with functional impairment). To date, the treatment of OA is only~     symptomatic and no drugs are able to stop the degradative process of cartilage.~      50% of patients with hand OA exhibit a functional impairment responsible for a severe~     handicap, which is almost similar to rheumatoid arthritis. While the risk factors of hand OA~     are well identified (i.e., familial history, female sex, menopause, obesity), clinical~     outcome in large cohort is poorly known. In addition, the investigators miss predictive~     clinical, biological or imaging factors of severe clinical (i.e. pain, functional impairment~     or aesthetic damage) or structural evolution (i.e., aggravation of radiographic scores).~      Primary objective To investigate in hand OA patients predictive clinical, biological,~     genetic and imaging factors of clinical aggravation after 6 years of follow-up.~      Secondary objectives To investigate in hand OA patients predictive clinical, biological,~     genetic and imaging factors of clinical aggravation after 3 years of follow-up.~      To investigate in hand OA patients predictive clinical, biological, genetic and imaging~     factors of clinical aggravation after 3 years of follow-up.~      To investigate whether variations of clinical evaluation of hand hand OA and radiographic~     structural changes are associated or correlated between inclusion and 3 years of follow-up~     or between inclusion and 6 years follow-up To investigate whether clinical status and~     radiographic alterations are correlated at inclusion To determine whether hand OA is~     associated with OA at other sites or with other hand diseases (carpal tunnel syndrome,~     tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at~     inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and~     imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or~     during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic~     and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up~     in the erosive hand OA subgroup~      Methods :~      the investigators plan to include 500 patients in the cohort (5/week) 7 visits (one per~     year) are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA~     will be performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs~     of other OA localisation (if symptomatic) will be performed.~      A blood sample will be taken at inclusion for biomarker studies and genetic investigations.~      A blood sample will be taken at M36 and M72 to build a prospective serum collection.~      Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study~     for one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine~     Hospital with a multicentric international steering committee~      Potential outcomes :~        -  Identification of clinical, radiological and biological tools useful to predict~          clinical and structural outcomes~        -  Description of the history course of hand OA and predictive factors of severe evolution~          (i.e. erosive form of hand OA) To integrate in daily practice, clinical and~          radiological tools allowing a standardized follow up of hand OA patients.~   "
93633|NCT01831557|"~     The objective of this study is to explore the genetic basis of the influence of dairy~     product intake on body measures in children. The investigators assume that the effect of~     dairy products intake on children body measures is affected by genetic polymorphisms.~   "
93634|NCT01831544|"~     This multi-center, prospective, non-randomized, single-arm trial will investigate the safety~     and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over~     24 months in subjects with advanced heart failure~   "
93635|NCT01831531|"~     This trial aims to study the safety, the local control, and the overall survival of S-1~     combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105~     patients will be recruited into this trial.~   "
93636|NCT01831518|"~     Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart~     in order to improve the coordination of the contraction in patients with heart failure.~     Current selection criteria incorporate the severity of the symptoms, the mechanical function~     of the heart and the time it takes the electrical stimulation to spread over the left~     ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these~     criteria only seem to select approximately 70% of the patients who might respond to this~     invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical~     activation of the heart in more detail than the standard ECG. This study aims to determine~     whether this new technology may aid current selection criteria in predicting response to~     CRT.~   "
93637|NCT01831505|"~     Many cancer patients are prescribed drugs to which their cancer is already resistant - and~     thus suffer toxicity with no potential for benefit. Previous attempts to assess~     chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human~     patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph~     nodes in situ respond to standard of care therapeutics precisely microinjected with the~     CIVO(tm) microdosing system.~   "
93638|NCT01831492|"~     Purpose:~      This study investigates the effects of dietary zeolite + dolomite on performance,~     exercise-induced acidosis, oxidative stress, inflammation and intestinal barrier dysfunction~     in trained people.~      Hypotheses (H1):~      Zeolite + dolomite increase performance in an ergometer step test Zeolite + dolomite reduce~     exercise-induced acidosis Zeolite + dolomite reduce oxidative stress Zeolite + dolomite~     reduce inflammation Zeolite + dolomite improve intestinal barrier dysfunction~   "
93643|NCT01831427|"~     This is a staggered, placebo-controlled, single and multiple ascending dose (SAD/MAD) study~     evaluating the safety, tolerability and pharmacokinetics of GS-5745 in participants with~     moderately to severely active ulcerative colitis. This study will provide valuable data that~     can help establish the safety, pharmacokinetics and efficacy of GS-5745 in participants with~     ulcerative colitis.~   "
93644|NCT01831414|"~     Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless~     environment and which is often used in patients with spinal cord injury. In normal subjects,~     water immersion generates a reduction in lung volumes. The effects of water immersion on the~     respiratory function of spinal cord injury patient (who are liable to present a respiratory~     failure secondary to paralysis) are not well known. They could be deleterious (by majoring~     respiratory failure)or beneficial (by mimicking the effect of a corset and improving~     respiratory function). Therefore, we are planning to study the effect of different water~     immersion levels on the respiratory function of spinal cord injury patients.~   "
93645|NCT01831401|"~     Total Hip Arthroplasty (THA) is one of the most commonly performed orthopaedic operations~     worldwide. The main aim is overall improvement in levels of patient pain and mobility. Such~     surgery involves implantation of both an acetabular and femoral component. With the patient~     in the lateral decubitus position, the Orthopaedic Surgeon assumes that the pelvis is in a~     neutral position with respect to all three body planes at the time of acetabular component~     implantation.~      With regard to THA, the current orthopaedic literature demonstrates a clear relationship~     between acetabular component positioning, polyethylene wear and risk of dislocation.~     Problems with edge loading, stripe wear and squeaking are also associated with higher~     acetabular inclination angles, particularly in hard-on-hard bearing implants.~      The important parameters of acetabular component positioning are depth, height, version and~     inclination.~      Control of acetabular component inclination, particularly in the lateral decubitus position,~     is difficult and remains a challenge for the Orthopaedic Surgeon.~      Accurate implantation of the acetabular component within the 'safe zone' of radiological~     inclination is dependent on:~        -  Operative version~        -  Operative inclination~        -  Pelvic position (Primarily, but not exclusively, abduction / adduction.)~      This study aims to investigate the effect of patient pelvic positioning and method of~     acetabular component insertion on acetabular component inclination during Total Hip~     Arthroplasty (THA).~   "
93646|NCT01831388|"~     The purpose of this study is to test whether a breath training exercise program may be used~     to make patients with chronic lung conditions feel less short of breath, whether such a~     program is well received by patients and whether a future larger study is worthwhile.~      The breath training exercise program uses some breathing techniques derived from Yoga~     practices. They were shown to help patients experiencing shortness of breath feel less short~     of breath in other settings. Whether the training is beneficial to patients with chronic~     lung conditions, especially those with a history of cancer affecting their lungs, is not~     clear. This study would help us answer that question.~   "
93647|NCT01831375|"~     This research represents a pioneering effort to design a brief, cost effective and readily~     transportable program that will enable disadvantaged elders to become more effective~     participants in their health care.~      The intervention is expected to result in trained elders becoming more knowledgeable health~     care partners. Trained patients will be prepared for appointments and will engage their~     primary care physicians in active dialogue regarding cancer prevention and screening.~      Based on self-advocacy, these patients are expected to receive better preventive care and~     report greater satisfaction with care. Program participation can subsequently contribute to~     general health improvements and minimize health disparities.~   "
93648|NCT01831362|"~     This study addresses NCCAM's request for research that investigates the neuropsychological~     mechanisms underlying mind-body therapies, and for precise criteria and better delineation~     of meditation practices.~      The purpose of this study is to assess the clinical efficacy and mechanism of action of 2~     component practices of mindfulness meditation, i.e. focused awareness (FA) and open~     monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based~     Cognitive Therapy (MBCT).~   "
93649|NCT01831336|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
93650|NCT01831323|"~     To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota~     of diverticular disease, comparing it with the effects exerted by supplementation with~     fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each~     specific treatment~   "
93651|NCT01831310|"~     Hypercatabolism and immune suppression are frequently seen in patients with malignancy.~     Preoperative nutritional state is an important factor in determining surgical and~     postoperative complications because the preoperative nutritional status affects the~     postoperative nutritional state, immunity and inflammatory response. In these patients,~     standard parenteral nutrition may not be sufficient to maintain the immunity and provide~     positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with~     immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T~     lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor-~     alfa. There is a report which showed that glutamine dipeptide supplemented parenteral~     nutrition improved the cellular and humoral immune functions. The investigators aimed to~     evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid~     supplemented parenteral nutrition on the neutrophil functions and postoperative course of~     patients with colorectal cancer.~   "
93652|NCT01831297|"~     This study´s aim is to explore physiological associations concerning pulse wave velocity,~     heart rate and blood pressure in order to make taking the blood pressure more comfortable.~   "
93653|NCT01831284|"~     The goal of this study is to learn how injection drug use may affect the immune system.~   "
93697|NCT01830712|"~     This study is conducted in the United States of America (USA). The aim of this study is to~     assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic~     surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and~     F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial~     outcomes, frequency of bleeding episodes and durability of joint surgery.~   "
93654|NCT01831271|"~     The overall objective is to evaluate if treatment with a neck-specific exercise program and~     cognitive behavioural approach improves the outcome compared with prescribed, self-mediated~     and progressive physical activity in patients with cervical radiculopathy. There is a lack~     of evidence of the best treatment for the patient category. Many patients are sick-listed~     for long periods of time with different kind of treatment approaches or without any~     treatment at all. The present study could fill the identified knowledge gap by strengthening~     of the currently weak scientific evidence for treatment of the patient category. The~     long-term effects of the study could be to reduce the time for sick leave and improve the~     rate of patients returning to work and/ or former activity by optimising treatments. Further~     on, to decrease the number of patients who finally have surgery for their neck problems and~     thus reducing the mental, physical and social costs.~   "
93655|NCT01831258|"~     Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the~     pressure during wakefulness may improve therapy comfort and potentially adherence without~     compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed~     by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of~     the transition from sleep to wake. When the transition from sleep to wake is detected the~     device promptly reduces the pressure to help facilitate a return to sleep.~      The purpose of this study is to compare adherence and sleep quality outcomes in patients~     treated by CPAP with and without SensAwake technology.~      It is hypothesised that participants with SensAwake on will have improved adherence and~     sleep quality.~   "
93656|NCT01831245|"~     Register study. Patients who had been operated for right-sided colon tumor or benign~     adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery~     in an ERAS (Enhanced Recovery After Surgery) protocol.~      Hypothesis:~      Operation of right-sided colon tumor and large benign adenoids, a better selection of~     patients for open or laparoscopic surgery can improve short term results.~   "
93657|NCT01831232|"~     This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating~     patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs~     used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium~     may kill more cancer cells.~   "
93658|NCT01831219|"~     This is a follow-up study looking at the and long-term results of two methods of preparing~     the thigh bone to receive an implant during hip replacement surgery. For one group of~     patients in the original study, the surgeon used a cutting tool called a broach and a~     special hammer on patients who had standard hip replacement operations. For the other~     patients, the surgeon used a surgical robot which was equipped with a cutting tool, like a~     drill, to prepare the thigh bone. The purpose of this study is to collect additional~     information confirming that the surgical robot is safe and effective when used as~     recommended. Only patients who were enrolled in the original clinical trials are eligible~     for this study.~   "
93659|NCT01831206|"~     The purpose of this study is to evaluate the efficacy of collagen cross-linking for~     treatment of infectious keratitis.~   "
93660|NCT01831193|"~     The purpose of this study is to determine if the oral supplementation with curcumin reduces~     proteinuria in patients with chronic kidney disease regardless the ethiology.~   "
93661|NCT01831180|"~     The purpose of this study is to compare the differences in various chemical and biologic~     parameters of scalp and and hair parameters between young and old Caucasian females. The~     hair state and scalp blood flow in younger and older age groups with typical hair care~     practices will be qualified by measuring various parameters of the hair shaft and scalp with~     correlation back to hair and scalp satisfaction as measured in the subject. This is a single~     center study with an anticipated 4 month enrollment period. The investigators will compare~     various scalp and hair parameters between young and old Caucasian females by obtaining the~     following biological and chemical/structural information. Hair growth rate, anagen to~     telogen ratio, hair density (determined via phototrichogram and digital imaging), Vascular~     blood flow (Laser Doppler Flowmetry), Histamine stimulation and Hair diameter (clipped~     hairs). In addition, a detailed questionnaire will be administered to each subject regarding~     satisfaction of the subject's hair state, including typical hair care regimens and symptoms~     in scalp and/or hair shafts. This information will be correlated to the biologic and~     chemical/structural information about hair and scalp health. Approximately 50 healthy,~     Caucasian female subjects will be enrolled in this study. Twenty five participants will be~     19-25 years-old and 25 participants 60 years or older. There will be two visits, Baseline~     and approximately 48 hours after baseline.~   "
93662|NCT01831167|"~     In two sessions of four days nurses will be exposed to dynamic lighting and normal~     (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention)~     and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two~     tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue~     and mood, sleep and Questions of Life.~   "
93663|NCT01831154|"~     The purpose of this study was to investigate the effects of three different glycemic~     treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1)~     postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive~     protein levels in patients undergoing open-heart surgery. Secondary aims of the study were~     to investigate the effects of the three glycemic treatment conditions on: 1) intraoperative~     blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of~     stay, in patients undergoing open-heart surgery.~   "
93723|NCT01830374|"~     The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine~     and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight~     suppression and current dieting status in women with bulimia nervosa. The investigators have~     differentiated between a diet-induced long-term energy imbalance (weight suppression, or the~     difference between one's highest-ever body weight and current weight) and a short-term~     energy imbalance (current dieting to either lose weight or avoid weight gain). This study~     will elucidate how two common yet largely unexplored types of dieting influence biological~     and behavioral variables in patients with bulimia nervosa, which could lead to modifications~     of prevailing models of bulimia nervosa and new strategies for improving treatment outcome.~   "
93664|NCT01831141|"~     Congenital solitary kidney (CSK) is a disorder caused by an abnormal development of one of~     the two kidneys. The reported incidence ranges between 1:450-3200. It is debated whether CSK~     is a benign condition or not. A variable risk of developing proteinuria (11-27%),~     hypertension (0-60%) and chronic kidney damage (3.5-30%) is described. This knowledge~     derives mainly from retrospective studies performed in tertiary medical centers which is~     difficult to compare for the following reasons: the number of individuals evaluated, the~     length of follow-up and the outcome studied.~      The aim of this longitudinal study is to assess, in a cohort of children with congenital~     solitary kidney, during a 10 year follow-up period: 1) the rates of developing proteinuria,~     hypertension and chronic kidney disease and the corresponding potential prognostic factors.~     2) the role of new biomarkers of glomerular (Cystatin C) or tubular damage (NGAL, NAG,~     B2-microglobulin) in predicting the appearance of chronic kidney damage.~   "
93665|NCT01831128|"~     The purpose of FACE study is to provide in routine practice complementary long-term data on~     the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea~     eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).~   "
93666|NCT01831115|"~     To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's~     history, physical examinations and technical devices in patients presenting with acute~     dyspnea.~   "
93667|NCT01831102|"~     The purpose of this protocol is to measure and compare levels of the circulating protein~     adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and~     non-Latino white subjects. The investigators also aimed to examine associations between~     nutritional factors and adiponectin levels.~   "
93668|NCT01831089|"~     Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in~     patients with solid tumors~   "
93669|NCT01831076|"~     This phase II trial studies how well exemestane before surgery works in treating~     postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast~     cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.~   "
93670|NCT01831063|"~     Caregivers of children with seizures receiving simulation based seizure management teaching~     in addition to the traditional seizure teaching will report more confidence with seizure~     management and demonstrate a higher level of performance with seizure management.~   "
93671|NCT01831050|"~     This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted~     in healthy Latin American infants, utilizing one or two supplemental doses of IPV in~     children previously vaccinated with 3 doses of bOPV. We will examine the impact of~     supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer~     comparability, and safety.~   "
93672|NCT01831037|"~     This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB)~     experiencing regression of liver cirrhosis after effective antiviral therapy have decreased~     risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in~     patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to~     identify the magnitude of the decreased risk for HCC in patients experiencing regression of~     fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought,~     in order to determine a subset of patients in whom it will be safe to stop surveillance.~   "
93673|NCT01831024|"~     The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will~     be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant~     chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair~     loss will be evaluated by patient self assessment of 5 standardized photographs taken prior~     to each chemotherapy cycle. A concurrent control group not using a cold cap will also be~     evaluated.~   "
93674|NCT01831011|"~     Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic~     drug. This study aims to evaluate the efficacy and safety of mildronate injection in~     treating acute ischemic stroke.~   "
93675|NCT01830998|"~     The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals~     with type 2 diabetes.There are no established specific treatment measures to prevent or~     ameliorate cognitive impairments in patients with diabetes. we want to detecte early~     clinical dementia in diabete.~   "
93676|NCT01830985|"~     This study is designed to evaluate the long-term safety and tolerability of VX-509 in~     subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll~     subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).~   "
93677|NCT01830972|"~     GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic~     myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA). The purpose of~     the study is to measure long term safety and the effects of Sialic Acid-Extended Release~     (SA-ER) tablets and Sialic Acid-Immediate Release (SA-IR) capsules.~   "
93678|NCT01830959|"~     Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis.~     These can lead to worsening of disease for both the short and long term.~      Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients~     with COPD.~      Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to~     determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic~     sarcoidosis.~   "
93698|NCT01830699|"~     To date no trials have been performed looking at whether or not intra-bursal injection of an~     IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The~     subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder~     pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving~     pain but this information was presented as a case series in a letter to the editor format,~     so the validity of these results would require additional testing [Omoigui S, et al. 2004].~     Based mainly on the data from the intra-articular administration of anakinra, there have not~     been any adverse trends in outcomes or safety to suggest that intra-bursal injection of~     rilonacept will carry an increase risk of adverse events. The purpose of this trial is to~     compare the improvement in pain and function of patients with clinical symptoms and signs of~     subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).~   "
93679|NCT01830946|"~     Obesity is recognized as a major public health concern because of its link to potential~     fatal complications arising from metabolic and cardiovascular diseases. Despite many~     pharmacological advances in this field, lifestyle strategies that emphasize proper nutrient~     intake and physical activity continue to be the primary strategy for individuals to fight~     obesity. However, controversy exists regarding the type and timing of exercise and specific~     nutrient intake to maximize fat loss, muscle gain, and beneficial cardio-metabolic~     adaptations derived from these lifestyle interventions. Furthermore, limited data exists~     investigating the impact of nutrient timing at times other than immediately before or after~     exercise and no studies have examined time-of-day nutritional intake in overweight or obese~     individuals.In addition, many individuals attempting to improve body composition and~     cardio-metabolic health are concerned with what food choices are appropriate in the late~     evening to support positive physiological adaptations. However, research-based information~     examining this topic is scarce.~      The investigators hypothesize that consumption of a protein beverage in the late evening~     before sleep will improve body composition, cardio-metabolic health, and adaptations to~     exercise more than an isocaloric placebo beverage. The investigators also hypothesize that~     the different digestion and absorption kinetics of whey and casein proteins will elicit~     different effects on the measures variables.~   "
93680|NCT01830933|"~     The proposed research combines the scientific advances in breast cancer research with health~     information technology (IT) to design a personalized intervention that assesses breast~     cancer risk for women, disseminates important breast health information, and facilitates~     discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC~     (personal computer) based breast cancer risk education (BreastCare) intervention in the~     primary care setting that estimates a woman's individual risk for breast cancer and provides~     her and her physician with personalized breast cancer risk information and recommendations~     for action.~   "
93681|NCT01830920|"~     The purpose of this study is to determine whether THR-184 when administered around the time~     of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the~     development of acute kidney injury.~   "
93682|NCT01830907|"~     Evaluation of the impact of preoperative nutritional support on clinical outcomes in~     patients at nutritional risk. The primary endpoint was the complication rate and the second~     endpoint was the length of stay.~   "
93683|NCT01830894|"~     MRI research Group in the Advanced Technology Center of the Sheba Medical Center has~     developed an innovative methodology based on leakage (extravasation) contrast agent that~     allows to map the entire brain with high resolution and high sensitivity to check and~     describe disorders BBB (blood brain barrier).~      The aim of the current study is to evaluate the feasibility of the BBB disruption detection~     method to predict delayed peri - hemorrhage edema.~   "
93684|NCT01830881|"~     The purpose of this study is to determine the level of pain, anxiety and side effects that~     women experience with a surgical abortion and the effect that the anti-anxiety medication,~     midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead~     of the standard pain treatment of only ibuprofen and a PCB.~   "
93685|NCT01830868|"~     This is a Non-interventional Prospective Study. Centres will enroll adult patients with~     partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive~     therapy prior to the decision to take part in this study. Patients to be enrolled into the~     study are not sufficiently controlled with one dug licensed for the use of monotherapy in~     partial onset seizures. Patients will be seen at baseline and then during normal clinical~     visits at intervals which are appropriate to the typical practice of the treating clinician.~     Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.~   "
93686|NCT01830855|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study whether healthy adolescent subjects receiving different lots of vaccine respond in a~     similar way. The study will also look at the safety of the new vaccine as well as how it is~     tolerated.~   "
93687|NCT01830842|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to~     investigate the acute and chronic effects of nicotine on motivational behavior and~     prediction error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will~     undergo fMRI scans on two separate occasions while performing a decision-making task that~     will elicit prediction error signals in the mesocorticolimbic pathway of the brain.~     Nonsmokers will be scanned once following an acute dose of nicotine and once following~     placebo administration. Smokers will be scanned once following smoking as usual and once~     following 24-hours of smoking abstinence, in order to measure the effects of nicotine~     withdrawal. The study team hypothesizes that acute nicotine will increase the prediction~     error signal in nonsmokers compared to placebo, and that nicotine withdrawal will decrease~     the prediction error signal in smokers compared to the normal satiated condition.~     Furthermore, nonsmokers (during the placebo condition) will have greater prediction error~     activation than smokers (during the satiated condition). The results of this study will~     inform whether the initiation and maintenance of smoking behavior could be facilitated by~     the effects of nicotine on reinforcement learning.~   "
93694|NCT01830751|"~     The purpose of the proposed study is to test the effect of an intervention technique that~     reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and~     functional impairment in individuals with chronic or recurrent non-specific low back pain~     (LBP). The intervention is a self-administered and requires no medical intervention or~     drugs. The technique referred to as the restrained sitting treatment (RST), involves~     training in minimizing forward bending of the trunk immediately upon rising. The technique~     builds upon a previous randomized controlled study conducted and published by members of the~     research team. The underlying premise of RST exploits the natural diurnal pattern as the~     intervertebral discs (people are tallest when they first wake up). The discs are fully~     hydrated upon rising, disc internal hydrostatic pressures and external forces acting on~     surrounding soft tissues are greatest at this time, and these pressures and forces can~     increase significantly with trunk flexion. The RST technique utilizes a back support used in~     sitting during the first hour upon rising to minimize trunk flexion during this critical~     period as the intervertebral discs begins the diurnal cycle of fluid loss. The study will~     test the null hypothesis that there are no significant difference in outcome (LBP, work or~     social function/disability) between groups performing RST, the experimental group performing~     RST upon rising, the control group performing prior to going to bed.~   "
93688|NCT01830829|"~     Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45~     associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms~     and is in part related to prostate enlargement and obstruction. The standard medical therapy~     for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha~     blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the~     combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH~     also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain~     syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset~     of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS~     (organ specific phenotype) is the third most prevalent prostate disease after prostate~     cancer and BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant~     percentage of urology outpatients (3-8% of male outpatient visits)resulting in a major~     impact on quality of life of patients and economic costs to society. Clinical phenotyping~     allows for prediction of the patients with CP/CPPS most likely to respond to dutasteride and~     tamsulosin (age, Lower Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]).~     It can be estimated that up to 30% of men currently diagnosed with CP/CPPS will include men~     with co-existing Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of~     JALYN (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in~     men diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower~     Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg.~     BPH and CP/CPPS).~   "
93689|NCT01830816|"~     This is a phase 1/1b, open-label, multicenter study of oral ixazomib (MLN9708)designed to~     assess the pharmacokinetics (PK) of single dose ixazomib in patients with normal renal~     function and in patients with severe renal impairment (RI) (according to Cockcroft-Gault~     estimates). Twenty-eight PK-evaluable patients will be enrolled in either 1 of the 2 arms of~     the study.~      Arm 1: (N = 12): Normal renal function (creatinine clearance [CrCl] ≥ 90 mL/min)~      Arm 2: (N = 16): Severe RI (CrCl < 30 mL/min) including at least 6 patients with ESRD,~     defined as renal failure requiring hemodialysis~   "
93690|NCT01830803|"~     Quality of life and patient satisfaction are two important concepts in health care,~     especially in chronic diseases. Currently, there are several instruments available to~     determine this, but many are not easily applicable in daily practice because of their length~     and the consequential effort they require from both patients and caregivers.~      In the UK, Benson et al. recently developed two short generic patient questionnaires on~     quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both~     questionnaires contain four items.~      The howRU questionnaire has already been validated and seems highly applicable to be used in~     large patient groups. The howRwe questionnaire has not been validated yet. The reliability~     of both questionnaires has not been assessed either. The procedure as suggested by Kocks et~     al. provides us with the opportunity to perform a reliability procedure on patient level.~      The purpose of this study is to assess the reliability of the howRU and the howRwe~     questionnaires on patient level in the Dutch population.~   "
93691|NCT01830790|"~     Choroidal thinning has been hypothesized to partake in the pathogenesis of age-related~     macular degeneration (AMD), but it is not known if increasing choroidal thickness may~     potentially alter the disease course. Past studies have shown that a single dose of the~     phosphodiesterase type-5 inhibitor sildenafil citrate can increase choroidal thickness in~     young healthy patients. The investigators hypothesize that sildenafil may also increase~     choroidal thickness in eyes with AMD and perhaps potentially reduce AMD progression.~     Alternatively, if sildenafil has minimal effect on choroidal thickness in eyes in patients~     with AMD, such results may suggest that choroidal vascular compliance or stiffness is~     reduced in this condition. Patients seen at the Duke Eye Center with a diagnosis of AMD or~     age-matched control subjects with no macular pathology will be administered a single 100mg~     oral dose of sildenafil citrate (Viagra®; Pfizer), and undergo EDI-OCT imaging before and~     after treatment. Images obtained will be used to measure choroidal thickness, as well as~     central macular thickness (CMT) and macular volume (MV). Choroidal thickness changes after a~     single-dose sildenafil treatment in AMD patients will be compared with age-matched control~     subjects using standard statistical methods. By also correlating choroidal thickness changes~     with functional (visual acuity) and anatomical (CMT & MV) changes, the investigators hope to~     further their understanding of the choroid's role in aging and AMD pathogenesis. The safety~     of a single dose of sildenafil citrate will be addressed by excluding any patients with risk~     factors or using medications that are contraindicated for sildenafil as determined by~     careful informed consent and a study questionnaire.~   "
93692|NCT01830777|"~     This research study is a Phase I clinical trial. Phase I trials test the safety of an~     investigational drug or combination of drugs. These trials also try to define the~     appropriate dose of the investigational drug to use for further studies. Investigational~     means that the combination of drugs is still being studied and that research doctors are~     trying to find out more about it. As part of this research study, patients will be~     administered brentuximab vedotin in combination with a conventional re-induction~     chemotherapy regimen called MEC, which consists of the chemotherapy drugs mitoxantrone,~     etoposide, and cytarabine. Brentuximab vedotin has not been approved by the FDA for the~     patient's cancer. However, brentuximab targets a protein on tumors called CD30, and it is~     approved for other cancers which express CD30, and these include Hodgkin lymphoma. This~     means that the FDA has not approved giving brentuximab in conjunction with MEC for use in~     people, including people with this type of malignancy, acute myeloid leukemia (AML).~      Mitoxantrone, etoposide and cytarabine are chemotherapy agents that are commonly used to~     treat individuals with relapsed AML. Brentuximab is an antibody-drug conjugate (ADC), which~     is the combination of an antibody (a protein that binds to cells) and a drug. Brentuximab~     vedotin works by using the antibody portion to enter into CD30-positive cells and then~     releasing the drug portion, which attempts to destroy the cell. Brentuximab vedotin has been~     used in laboratory and other research studies and information from those studies suggest~     that brentuximab vedotin may slow down the spread of cancers which express CD30. Some AML~     cell express CD30, so investigators hope that brentuximab vedotin will help with this type~     of AML.~      The primary purpose of this research study is to determine the highest dose that Brentuximab~     vedotin can safely be given with MEC without severe or unmanageable side effects. The dose~     identified in this study will be used in future research studies.~   "
93693|NCT01830764|"~     The purpose of this study is assess the safety and tolerability of lemuteporfin topical~     solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy~     volunteers.~   "
93695|NCT01830738|"~     The main objective of the study is the comparison of the effective duration of~     hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical~     technique versus an conventional multi-port technique.~   "
93696|NCT01830725|"~     Determine whether a relationship exists between polymorphisms of the genes XDH, HPRT1, and~     PRPS1 and gout, hyperuricemia, or the dose of xanthine oxidase (XO) inhibitors to reach a~     goal serum uric acid of less than 6 mg/dL. This study is observational in nature as no dose~     adjustment of XO inhibitors will be made by study investigators.~   "
93700|NCT01830673|"~     The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous~     immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical~     symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher)~     were included. The patients were allocated to three study groups:~      Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment)~     Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant~     grass pollen allergy without SCIT.~      The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the~     patients to record symptoms during the adjacent pollen season. A blood sample was drawn to~     analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5,~     IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).~   "
93701|NCT01830660|"~     Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of~     increasing platelet count in animal and human. This study is designed in dose escalation~     fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.~   "
93702|NCT01830647|"~     This prospective observational study will evaluate the safety and efficacy of first-line~     Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice~     in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for~     the duration of their treatment and a 30-day follow-up after the last dose of study drug.~   "
93703|NCT01830634|"~     Background: Accidental falls result in major physical and psychological morbidity in the~     elderly.~      Aim: To evaluate effects of lower-limb strength and flexibility program, which is analyzed~     under the control of other risk factors, on preventing recurrent falls and fall- related~     injuries in the community-dwelling elderly faller.~      Methods: The randomized double blind, longitudinal study will enroll about 780 elderly~     fallers, who are aged more than 70 years old. They are retrieved from the Adult Health~     Examination and allocated into intervention group and control group. All the fallers have~     at least one risk factor of accidental falls and no indication for exclusion criteria.~     Health professionals assess the risk factors of falls and provide medical educations and~     suggestions to all subjects concerning modification of environmental hazards, dizziness,~     multiple drugs use, and general transfer skill, etc. Physical therapists instruct the~     elderly of intervention group to do lower-limb strength and flexibility program by the aid~     of Theraband. There are three times of variables measurement at baseline, 6 months and 12~     months after examination. Differences in baseline characteristics between groups are tested~     by independent samples t test, Mann Whitney U test, or Chi-square test. To compare the~     outcomes in different groups, the investigators evaluate balance and mobility with multiple~     linear regression, accidental falls or not with logistic regression, and all-related~     injuries with Cox's proportional hazard model.~   "
93704|NCT01830621|"~     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,~     or better to receive no further treatment for colon or rectal cancer. To do this, half of~     the patients in this study will get BBI608 and the other half will receive a placebo (a~     substance that is designed not to do anything).~   "
93705|NCT01830608|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in the Western~     World. The etiology and pathogenesis of this disease remain largely unknown. In Europe about~     two million people suffer from AMD. According to the Age-Related Eye Disease Study (AREDS)~     the disease can be classified into early, intermediate and late. Early age-related macular~     degeneration is characterized by the presence of small or medium-sized drusen and/or retinal~     pigmentary abnormalities. Intermediate age-related macular degeneration is characterized by~     large drusen or numerous medium-size drusen and/or geographic atrophy not extending to the~     center of the macula. Late age-related macular degeneration can be either atrophic with~     extension to the macula or neovascular. The late form of the disease is associated with a~     pronounced loss of visual acuity.~      In the recent years several studies focused on risk factors for late AMD and a recent~     systematic review and meta-analysis reported risk factors for AMD based on 16 studies in~     almost 114000 subjects. Strong and consistent associations with late AMD for found for~     increasing age, current cigarette smoking, previous cataract surgery, and a family history~     of AMD. Consistent associations between late AMD and higher body mass index, history of~     cardiovascular disease, hypertension and higher plasma fibrinogen were also found, but the~     association was weak. Inconsistent associations were found for gender, ethnicity, diabetes,~     iris color, history of cerebrovascular disease, serum total and HDL cholesterol and~     triglyceride levels.~      Evidence has also accumulated that other factors influence the risk for AMD. Several genetic~     risk factors have been identified in the last years including genes in the alternative~     complement pathway and the RMS2/HTRA1 region. In addition, post-hoc analysis of data from~     the AREDS study has indicated that reduced intake of the omega-3 free fatty acids~     eicosapentaenoic acid and docsahexaenoic acid are associated with the risk of late AMD~     thereby supporting previous population based studies. The AREDS study also revealed that~     reduced intake of the macular pigment lutein and zeaxanthin may be associated with late AMD,~     again supporting previous population-based studies. Finally, 2 small studies indicate that~     reduced choroidal blood flow is associated with an increased risk of developing late AMD.~      Less data are available for the progression of early or intermediate AMD and the associated~     risk factors. This is at least partially related to the problems in quantifying progression~     of drusen size and volume. In the recent years, however, significant efforts have been~     achieved in optical coherence tomography (OCT)-based methods for quantifying drusen~     progression and drusen volume. Polarization-sensitive OCT is the most promising of these~     approaches and will be used to quantify drusen area and volume in the present study.~   "
93706|NCT01830595|"~     Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin~     (1500mg bid) for reducing inflammation among HIV positive participants.~   "
93707|NCT01830582|"~     The purpose of this study is to see whether three new types of MRI techniques used during~     magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to~     tell if the tumor is getting better in response to the radiation and/or chemotherapy~     treatments.~   "
93708|NCT01830569|"~     The purpose of this study is to assess the feasibility of the use of an evidence-based~     decision support system (EBMeDS) in daily Belgian family medicine and to study the~     effectiveness of EBMeDS use on improving diabetes care.~      Specific research questions are:~        -  Does family physicians use the EBMeDS system in daily practice?~        -  Does the use of the EBMeDS system by family physicians leads to an improvement in~          diabetes control compared to the control group?~   "
93709|NCT01830556|"~     Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of~     the head and neck whether progression free survival (PFS) in the arm with cetuximab,~     paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with~     cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.~      Secondary~      To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and~     neck the following study variables between both treatment arms:~        -  Best overall response~        -  Duration of response~        -  Time to treatment failure~        -  Overall survival~        -  Safety~   "
93710|NCT01830543|"~     The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban~     treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various~     combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel~     (or prasugrel or ticagrelor).~   "
93713|NCT01830504|"~     In France, 7-8 000 new thyroid cancer cases are diagnosed each year. Although a good overall~     prognosis, it is usually estimated that 10 to 20% will rescue and 5% will become metastatic.~      The standard treatment of advanced metastatic or recurrent thyroid cancer is limited to~     radioiodine therapy. It is estimated that 30 to 50% of patients will become resistant to~     radio iodine. Treatments options are limited in these refractory thyroid patients and long~     term survival is estimated to less than 10%. Nowadays, no drug is approved in this~     indication.~      The recent explosion in knowledge in tumour biology and the identification of potential~     biological targets in thyroid cancer led to several clinical trials with targeted therapies,~     mainly focused on TKI inhibitors targeting the MAPkinase pathway and/or VEGF. Preliminary~     results were encouraging in papillary thyroid tumors.~      Follicular (FTC) and poorly differentiated thyroid (PDTC) cancers account for 10% of thyroid~     cancer but 20-25% of cancers diagnosed at an advanced stage and near 50% of metastatic~     refractory thyroid cancers. These cancers with an aggressive behavior represent a major~     cause of death from thyroid cancer. In these subtypes, targeted therapies gave disappointing~     results. This may be related to the mutational profile of these tumors which is different~     from that of papillary cancers. Aberrant activation of the phosphatidylinositol-3-kinase~     (PI3K)/AKT pathway is thought to play a fundamental role in thyroid tumorigenenesis of~     follicular and poorly differentiated thyroid cancers. Many genetic alterations have been,~     recently, identified in this pathway. PIK3CA mutations are found in 10-15% of FTC and can~     also occur in metastases derived from PDTC. Amplification/genomic copy gain of the PIK3CA~     has been identified in 24% of FTC and 42% of PDTC. Epigenetic inactivation of PTEN which~     negatively regulates PI3K has been shown in FTC. Moreover, RAS mutations observed in 20-40%~     of FTC and PDTC can activate the PI3K/AKT by interacting with the RAS-binding site of the~     P110 catalytic subunit of PI3K.~      Due to the high frequency of activation of PI3K and downstream effectors in progressive,~     recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with~     BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic~     target and should be properly evaluated in advanced follicular and poorly differentiated~     thyroid carcinomas~   "
93714|NCT01830491|"~     The aim of this study is to demonstrate that the combination therapy of aspirin and~     clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with~     respect to its effectiveness in inhibiting platelet aggregation, if it is given for four~     weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting~     stent before > 12 months and had remained in a stable condition with a single antiplatelet~     agent, aspirin.~   "
93715|NCT01830478|"~     The purpose of this study is to determine whether lenalidomide in association with rituximab~     is effective in the treatment of patients with indolent non follicular NHL relapsed after~     >=2, but less than 4 prior lines of (immuno)chemotherapy.~   "
93716|NCT01830465|"~     The aim of this study was to evaluate the efficacy and safety of the combination of Velcade~     and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.~   "
93717|NCT01830452|"~     Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%.~     Many factors influence the onset and persistence of pain. Mesh characteristics and fixation~     have been pointed as important etiologic factors. This study compares two types of fixation~     for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this~     mesh will be fixed with non absorbable sutures. In the study group sutures will not be~     needed because of self gripping microhooks on the surface of the mesh.~      Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients~     will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will~     be done according to Lichtenstein as described by Amid et all. Included will be all~     unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the~     exclusion criteria. Patients will be followed for two years. The main endpoint is the amount~     of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain~     will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST).~     Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay,~     QOL, return to work and daily activities, genital and sexual problems. To demonstrate a~     difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is~     calculated.~      Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will~     cause less post-operative and chronic pain without enhancing the recurrence rate.~   "
93718|NCT01830439|"~     This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period,~     two-sequence, crossover, open-label study to evaluate the effect of food on the~     pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and~     extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a~     high-calorie, high-fat meal as compared with after a minimum 10-hour fast.~      For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be~     enrolled for a total of 32 subjects.~   "
93719|NCT01830426|"~     The purpose of this study is to establish the circulating tumor cell (CTC) assay as a~     surrogate for tissue diagnosis of suspected primary lung cancer. This is done through~     evaluating clinical and molecular markers to stratify the outcome/survival in patients with~     thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of~     California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.~   "
93720|NCT01830413|"~     Stenting for systematic Intracranial artery stenosis is challenged recently, especially for~     safety. This registry is aimed to explore the safety profile during peri-operation period in~     Stenting procedures for systematic Intracranial artery stenosis in Chinese population in~     real world.~   "
93721|NCT01830400|"~     This was a Non-interventional Prospective Study. Centres enrolled adult patients with~     partial-onset seizures with or without secondary generalisation for whom the clinician had~     decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the~     decision to take part in this study. Patients enrolled into the study were not sufficiently~     controlled with one drug licensed for the use as monotherapy in partial-onset seizures.~     Patients were seen at baseline and then during normal clinical visits at intervals. Patients~     in this study were assessed for efficacy and tolerability at baseline and then at least 3~     and 6 months after the baseline.~   "
93722|NCT01830387|"~     The purpose of this study is to compare the clinical outcomes and the operative costs of~     appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers.~     Prospective data will be collected before, during, and after surgery on patients undergoing~     a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after~     the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy~     patients at Duke Regional Hospital. Retrospective data will be collected from patients who~     had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an~     open appendectomy to compare outcomes.~   "
93724|NCT01830361|"~     To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated~     t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation~   "
93725|NCT01830348|"~     The purpose of the study is to determine if DSC127 is effective in increasing incidence of~     complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the~     vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have~     chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.~   "
93726|NCT01830335|"~     Environmental stress, such as low oxygen availability (hypoxia), has been associated with~     impaired neuromuscular performance; however, the mechanisms associated with these~     performance decrements remain unclear. While the majority of research suggests that the~     observed fatigue is related to the central nervous system, the influence of changes in~     cerebral blood flow (CBF) and associated changes in cerebral pH (partial pressure of carbon~     dioxide; PCO2) remains unexamined. In response to hypoxic stress, humans hyperventilate to~     maintain oxygen consumption, resulting in a hypocapnia mediated decrease in CBF and cerebral~     alkalosis (decreased PCO2). Previous research suggests that hyperventilation induces changes~     in neural excitability and synaptic transmission; however, it remains unclear if these~     changes are related to hypocapnia mediated decrease in CBF or cerebral alkalosis or both.~      The purpose of the proposed research program is to examine the influence of changes in CBF~     and cerebral alkalosis on neuromuscular function during environmental stress. The research~     program will consist of 2 separate projects, summarized below in a table outlining the~     proposed protocols and resultant physiological manipulations. During each manipulation,~     neuromuscular function will be evaluated and compared to baseline (normoxic) conditions~     using a repeated measures design.~      The research program will consist of 2 separate projects. Project 1 will examine the changes~     in CBF and alkalosis by using (a) indomethacin (decrease CBF; no change PCO2) and (b)~     hypocapnia (decrease CBF; decrease PCO2). Using a similar experimental design, Project 2~     will examine the change in CBF and alkalosis during hypoxia by using (a) poikilocapnic~     hypoxia (decrease PO2; decrease CBF; decrease PCO2), (b) isocapnic hypoxia (decrease PO2; no~     change CBF; no change PCO2) and (c) isocapnic hypoxia + indomethacin (decrease PO2; decrease~     CBF; no change PCO2). During each manipulation, neuromuscular function will be evaluated and~     compared to baseline (normoxic) conditions using a repeated measures design.~      Therefore, Project 1 will examine the separate and combined effect of changes in CBF and~     cerebral alkalosis on neuromuscular function independent of environmental manipulations.~     Subsequently, Project 2 will examine neuromuscular function during hypoxia while controlling~     CBF and cerebral alkalosis. It is hypothesized that changes in PCO2 and therefore, changes~     in cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF~     and oxygen availability.~   "
93727|NCT01830322|"~     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients~     with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The~     secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free~     Survival (PFS), and safety.~   "
93728|NCT01830309|"~     -  Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of~          CJ-12420 in healthy male subjects.~        -  Secondary~             -  To explore food effect on the pharmacodynamics (PD) of single oral dose of~               CJ-12420 in healthy male subjects(PD/PK group)~             -  To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects~               under fed or fasting condition.~   "
93729|NCT01830296|"~     Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized~     study tested the effects of coadministration of patient controlled remifentanil+morphine~     combination on postthoracotomy pain, analgesic consumption and side effects compared with~     morphine PCA alone~   "
93730|NCT01830283|"~     To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after~     the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella~     vaccination was promoted by Beijing Center for Disease Control and Prevention in November,~     2012.~   "
93731|NCT01830270|"~     If surgery remains the main treatment for gastric cancer without distant metastases;~     perioperative-chemotherapy increased the likelihood of progression free survival.~     Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to~     improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative~     chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to~     treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients~     could received post-chemotherapy, due to post-operative complications and toxicities. To~     overcome this limitation, the investigators will conduct a phase II clinical trial assessing~     the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P),~     epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric~     cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and~     paclitaxel/epirubicin combinations, sustain the development of dose density based on PET~     combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the~     effectiveness of this PET preoperative regimen~   "
93732|NCT01830257|"~     The investigators would remind the guardians of observation after immunization via sending~     short message and collect the information of AEFI by two ways, short message/telephone and~     website questionnaire.~   "
93733|NCT01830244|"~     The aim of this project is to evaluate tailored primary systemic therapy with sequential nab~     paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an~     open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy~     with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves~     high response rates. It is proposed that 60 patients will be enrolled in this study~     including 40 patients which are likely to have chemotherapy sensitive tumors and 20 patients~     who have ER positive tumors and are more likely to respond to hormonal treatment as an~     exploratory cohort. The target population is women with early breast cancer who are eligible~     for primary systemic therapy. The overall response rate in the breast will be measured.~     Secondary endpoints will include response rates in axillary lymph nodes, safety and~     tolerability and the rate of breast conservation. Participants will have a blood test to~     determine a specific genotype status that may help in predicting sensitivity to~     chemotherapy. This genotype test result is exploratory and will not influence selection of~     therapy for participants. Patients will also be given the option of having he their tumour~     tissues used in laboratory studies involving isolating cancer initiating cells from the~     tumor to subsequently generate breast cancer models in the laboratory and using aptamers~     (chemical antibodies) to target tumours.~   "
93734|NCT01830231|"~     Due to limited experience with cabazitaxel in TCCU, the study will be started as a~     randomised phase II study. The aim of the phase II study is to evaluate if the response~     rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III~     setting.~   "
93735|NCT01830218|"~     A national survey of current practices, preferred drug and technique choices for obstetric~     anesthesia and analgesia in Czech Republic.~   "
93736|NCT01830205|"~     The purpose of this study is to assess the effect of renal function impairment on the single~     dose pharmacokinetics of Daclatasvir.~   "
93737|NCT01830192|"~     The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial~     Malignancy (REM) in women with ultrasound endometrial abnormalities.~   "
93766|NCT01829802|"~     The purpose of this pilot study is to assess the efficacy and safety of the combination of~     RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic~     failure and PI and TDF naïve.~   "
93738|NCT01830166|"~     This project will develop and evaluate a treatment plan for prostate focal therapy based on~     low dose rate brachytherapy. The participants entering this study are those suitable for~     active surveillance. These participants will be monitored with various imaging methods and~     interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and~     transperineal mapping biopsy to determine the extent of cancer and suitable treatments.~     Those suitable for focal therapy will be offered the option of low dose rate brachytherapy~     (LDRB) focal therapy in addition to active surveillance or radical therapy.~      This study will be used to evaluate the long term use of multi-modal, multi-parametric~     prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such~     methods can be used to eliminate the need for invasive methods such as mapping biopsies.~   "
93739|NCT01830153|"~     This trial intends to test the efficacy and safety of RAD001 in patients with advanced~     sarcoma who failed to conventional chemotherapy.~   "
93740|NCT01830140|"~     This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or~     ocular hypertension (OHT).~   "
93741|NCT01830127|"~     To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD~     faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic~     impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a~     small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).~   "
93742|NCT01830114|"~     The objective of this pilot study is to evaluate the feasibility and technical merit of a~     web application for patients in primary care called Check-up and Choices (CC).~   "
93743|NCT01830101|"~     The investigators hope to improve overall median survival of patients with recurrent~     Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five~     treatments of re-irradiation.~   "
93744|NCT01830088|"~     Major depressive disorder (MDD) affects about 5% of adolescents and is on the rise both~     internationally and in Norway. Further, it is also associated with increased risk for~     suicide. Not surprisingly, depression is the largest reason for referral to specialty mental~     health services for adolescents (13-17 years) in Norway. Although anti-depressants and~     Cognitive behavioral therapy are strong treatments and have received extensive research, the~     best treatments show a recovery rate of only 37 %.~      There is a need to develop and test alternative treatments that can stand alone or augment~     anti-depressant medication. Family factors play an important role in the etiology,~     maintenance and relapse of depression. A promising family-based treatment (Attachment based~     family therapy- ABFT) was imported to Norway and its feasibility tested in a pilot~     randomized clinical trial with 20 families. The results showed promising treatment outcomes.~     Although the developers of the model have refined, adapted the model to suicidal ideation~     and built strong technology to support dissemination, a definitive study of ABFT for~     adolescents with major depression has not yet been conducted. Therefore the primary aim of~     this study is to test if ABFT is more effective that enhanced usual care (EUC) to treat~     clinic-referred adolescents with major depression. The investigators will test the~     hypothesis that 12 weeks of ABFT therapy will produce a greater proportion of adolescents~     report remission from depression and symptom change than 12 weeks of enhanced clinical care~     (EUC). Secondary research aims are i) to test a hypothesis that parent-adolescent conflict~     will be more sensitive to change for adolescents receiving ABFT that adolescents receiving~     EUC ii) to explore patterns of change in suicidal ideation in the recruited sample in the~     acute-phase treatment.~      Central challenges to the study are i) blinding therapists/patients, which is difficult in~     psychotherapy trials ii) lack of a standardized control condition, and iii) selecting and~     training regular staff therapists to high adherence levels. However, with tighter control~     over these factors than is normal for a typical effectiveness trial, the investigators~     expect results to show what to expect under the best of conditions in community clinics.~     Benchmark derived from the study will inform how to effectively train therapists and~     subsequently implement the model into mainstream services.~   "
93745|NCT01830075|"~     Background:~      It is widely recognised that spiritual care plays an important role in physical and~     psychosocial well-being of cancer patients but there is little evidence based research on~     the effects of spiritual care. The investigators will conduct the first randomized~     controlled trial on spiritual care using a brief structured interview scheme supported by an~     e-application. The aim is to examine whether an assisted reflection on life events and~     ultimate life goals can improve quality of life of cancer patients.~      Design:~      Based on the findings of the investigators previous research, the investigators have~     developed a brief interview model that allows spiritual counselors to explore, explicate and~     discuss life events and ultimate life goals with cancer patients. To support the interview,~     the investigators created an e-application for a PC or a tablet. To examine whether this~     assisted reflection improves quality of life the investigators will conduct a randomized~     trial. Patients with advanced cancer not amenable to curative treatment options will be~     randomized to either the intervention or the control group. The intervention group will have~     two consultations with a spiritual counselor using the interview scheme supported by the~     e-application. The control group will receive care as usual. At baseline and one and three~     months after randomization all patients fill out questionnaires regarding quality of life,~     spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health~     care consumption.~      Discussion:~      Having insight into one's ultimate life goals may help to cope with a life event such as~     cancer. This is the first randomized controlled trial to evaluate the role of an assisted~     structured reflection on ultimate life goals to improve patients' quality of life and~     spiritual well being. The intervention is brief and based on concepts and skills that~     spiritual counselors are familiar with, it can be easily implemented in routine patient care~     and incorporated in guidelines on spiritual care.~   "
93746|NCT01830062|"~     The aim of this study is to compare the relationship between the coronary artery~     calcification assessed by MDCT with the plaque characteristics and necrotic lipid core~     content of non-intervened coronary segments assessed with near infrared spectroscopy (NIRS)~     in patients with symptomatic coronary artery disease (CAD).~   "
93747|NCT01830049|"~     Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding~     aging population and the increase in life expectancy, an increase in the prevalence of ED is~     expected in the years to come. Currently, the mechanism of ED is not fully understood.~     MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression~     post-transcriptionally. It has been included in many in vitro physiology and pathophysiology~     processes, which also involved in the process of ED. This research was designed to~     investigate the differential plasma MiRNA profiles in ED and normal erectile function in~     older males. The results might tell us which MiRNA and how did it involved in the process of~     ED in aging.~   "
93748|NCT01830036|"~     Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation.~      The aim of the register is to enable a better diagnosis and early treatment initiation in~     the context of secondary prevention. In addition to the prevalence, the further course of~     the patients shall be documented after hospital discharge to verify any gaps (sleep~     laboratory, therapy introduction) and emphasize the importance of rehabilitation and to~     examine the possibility of initiating therapy in rehabilitation.~   "
93749|NCT01830023|"~     This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination~     will be done and the data will be compared to the other examinations.~   "
93750|NCT01830010|"~     Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part~     2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for~     hematological malignancies~   "
93914|NCT01827865|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to~     assess the bioequivalence between Test Product and the corresponding Reference Product under~     fasting condition in healthy, adult human subjects.~   "
93751|NCT01829997|"~     Spine fusion is one of the most common procedures performed in spinal surgery. Several~     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion~     (PLF) is the most widely used. However, complications can develop when the bone graft~     material used is insufficient to achieve the desired fusion. With its unique properties,~     nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to~     obtain new bone growth during the healing process.~      nanOss Bioactive 3D is approved for use in the U.S., however, additional information is~     useful to assess its efficacy in the posterolateral spine. The purpose of this study is to~     assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with~     autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result~     in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of~     translational motion, and less than 5 degrees of angular motion.~   "
93752|NCT01829984|"~     The purpose of this study is to compare two different ways of teaching people how to give~     injections at home. The first is what we do now, which is teaching patients and/or their~     caregivers verbally and by giving written instructions. The second is what we do now (verbal~     and written instructions) along with a demonstration and practice using a needle and an~     injection pad that feels similar to skin and fat. This is being done to find the best method~     for teaching people to give an injection at home.~   "
93753|NCT01829971|"~     This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or~     other selected solid tumors or hematologic malignancies. The drug is given intravenously,~     for 5 days in a row and then two weeks off.~   "
93754|NCT01829958|"~     This study will evaluate the ability of a largely self-administered geriatric assessment~     (GA) to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving~     chemotherapy or chemoimmunotherapy.~   "
93755|NCT01829945|"~     Several lines of evidence indicate that a significant proportion of cardiovascular disease~     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and~     perturbations, defined as the metabolic syndrome. It has been estimated that approximately~     25% of the North American adult population is living with the metabolic syndrome. Recent~     studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen~     in insulin-resistant patients is partly due to increased production rate of intestinally~     derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial~     evidence exists indicating that elevated levels of intestinal lipoproteins are associated~     with increased CVD risk. However, as indicated in the body of this grant proposal, the~     underlying mechanisms that lead to intestinal overproduction of lipoproteins in~     insulin-resistant states are poorly understood.~      The general objective of the proposed research is to investigate the mechanisms by which the~     metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is~     that insulin resistance will be associated with higher levels of intestinal lipoproteins~     because of an increased secretion of these particles.~   "
93756|NCT01829932|"~     Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose~     symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to~     influence the bacteria gut interaction. Our aim is to determine if components of the diet~     affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure~     whether after being on a diet high or low on certain factors there is a change in the timing~     and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS~     symptom severity.~   "
93757|NCT01829919|"~     The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and~     elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)~     Capsules 7.5 mg when given as a single dose and multiple doses.~   "
93758|NCT01829906|"~     Bariatric surgery is the only long-term established treatment for morbid obesity. However,~     some patients experience suboptimal weight loss after surgery and/or experience a~     significant weight regain. Unfortunately there are very few studies in this area and little~     is known about the causes for lack of success or the best approach to treat this group of~     patients. The main aim of this study is to compare the efficacy of two different lifestyle~     treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an~     inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a~     1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss~     after bariatric surgery.~   "
93759|NCT01829893|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly~     single pill combination of finasteride and tamsulosin with a conventional combination of~     finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label,~     2-sequence -2period crossover study.~   "
93760|NCT01829880|"~     The purpose of this study is to determine if cachexia and changes in body composition~     influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for~     renal function estimation.~   "
93761|NCT01829867|"~     The purpose of this study is to assess the safety and tolerability of a dose of 95μg sNN0031~     after intracerebroventricular administration to patients with Parkinson's disease~   "
93762|NCT01829854|"~     This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient~     undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open~     heart surgery .~   "
93763|NCT01829841|"~     -  Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1~          and Flt3. Phase I study has shown that the toxicity is manageable.~        -  The purpose of this study is to compare the efficacy and safety profile between~          Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.~   "
93764|NCT01829828|"~     The purpose of this survey is to investigate the usefulness of a patient self-reported~     scoring tool on patient satisfaction improvement.~   "
93765|NCT01829815|"~     The aim of this study is to assess the impact of an intervention to improve parenting~     practices, pre-academic and developmental skills, and use of mosquito nets for children in~     kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist~     controlled design will be conducted to measure the impact of the intervention on three~     primary outcomes: positive parenting skills, children's cognitive and educational skills,~     and malaria knowledge and prevention behaviors.~   "
93767|NCT01829789|"~     The purpose of this study is to test the efficacy and cost-effectiveness of Community~     Reinforcement Training (CRT) provided in a group therapy format. The goals of CRT are to~     teach parents behavioral and communication skills to influence their youth's drug use and~     encourage them to enter treatment. Thirty parents will be randomly assigned to Group CRT and~     30 will be randomly assigned to traditional, Individual CRT. Youth engaged in treatment will~     receive individual Cognitive Behavioral Therapy. Families are assessed for adolescent~     substance use and other areas of individual and family functioning. It is expected that~     Group CRT will be more effective for encouraging youth entry into treatment and improving~     parental functioning.~   "
93768|NCT01829776|"~     This pilot study will compare how often people with multiple sclerosis (MS) fall before~     participating in the Free From Falls (FFF) educational program, during the program, and for~     8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and~     convenience of an email survey to count how often people fall.~   "
93769|NCT01829763|"~     Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic~     stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often~     display spasticity due to the interruption of the descending pathways that control the~     spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex~     triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the~     gait, especially in strokes that are the main cause of neurological disability. While 80% of~     the stroke survivors recover the ability to walk, the poor quality of their gait constitutes~     a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).~      Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal~     spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle~     contraction by blocking the release of acethylcholine from motoneuron terminals at the~     neuromuscular junction and transiently paralyzing the muscle for several months. Besides~     this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004;~     Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the~     fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al.~     2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may~     be indirectly responsible for functional changes in central motor mechanisms at both spinal~     and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde~     axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal~     cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological~     findings are limited and controversial, probably due to the various motor disorders~     investigated, the physiological mechanisms tested and the different toxin injection~     protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997;~     Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995;~     Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains~     uncertain.~   "
93770|NCT01829750|"~     The purpose of this study is to investigate the efficacy of intracoronary infusion of~     cardiac progenitor cells in patients with univentricular heart disease. Patients with~     preoperative high-risk group or whose cardiac function did not recover postoperatively~     eventually have no choice other than heart transplantation.~   "
93771|NCT01829737|"~     Background:~      - Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a~     person who is infected with a kind of parasite called a gametocyte, it is able to spread the~     infection to another person. Not everyone infected with parasites have gametocytes in their~     blood. As a result, not everyone can spread malaria to others. Researchers are interested in~     learning more about why some healthy people have gametocytes in their blood and others do~     not. Identifying the people who have gametocytes in their blood can help target treatment~     and reduce the spread of malaria. This study will focus on the people of the village of~     Kenieroba in Mali, where malaria is common.~      Objectives:~      - To study the relationship between gametocytes and malaria transmission in Mali.~      Eligibility:~      - Individuals between 6 months and 65 years of age who live in Kenieroba, Mali, and will~     stay in the area for 1 year.~      Design:~        -  For 1 year, participants will have study visits once every 2 weeks (twice a month, for~          a total of 24 visits). The visits will last 30 minutes each.~        -  At each visit, participants will provide a small blood sample. They will report any~          symptoms of malaria such as fever, headache, and body aches. Participants will be~          encouraged to seek medical treatment if they experience malaria symptoms between~          visits.~        -  Participants who have malaria symptoms will have a blood test for malaria parasites.~          Those who have parasites in the blood will receive antimalarial treatment.~        -  Three times over 1 year, a larger blood sample will be collected. These blood samples~          will be taken once in the dry season, once in the wet season, and once in the next dry~          season.~        -  Women between 14 and 45 years of age will also provide urine samples to test for~          pregnancy. Pregnant women will not be asked to give blood samples.~   "
93772|NCT01829724|"~     Background:~      - Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS)~     and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it~     is active. EEG records electrical activity in the brain. Both have been used safely for many~     years, even in very young children. NIRS or EEG can be used while a person is moving to show~     which parts of the brain are the most active. Researchers want to use NIRS and EEG to study~     brain activity during movement in people with cerebral palsy and healthy volunteers.~     Learning more about how people with and without cerebral palsy use their brain to control~     their muscles may lead to new ways of training people with cerebral palsy to move better.~      Objectives:~      - To study how the brain controls body movement in people with and without cerebral palsy.~      Eligibility:~        -  Individuals at least 5 years of age who have cerebral palsy.~        -  Healthy volunteers at least 5 years of age.~      Design:~        -  This study has three parts. People with cerebral palsy will be selected for all three.~          Healthy volunteers will be asked to do only two of them. Everyone who participates will~          have NIRS and/or EEG exams during movement. People with cerebral palsy may also have~          biofeedback sessions to train coordination of movement and brain activity.~        -  Participants will be screened with a physical exam and medical history. Urine samples~          may be collected.~        -  All participants will have at least one session of NIRS and/or EEG imaging studies.~          Sessions may also include the following tests:~        -  Magnetic resonance imaging to look at the brain~        -  Electromyography to measure electrical activity of the muscles~        -  Motion analysis of specific body parts~        -  Ultrasound to measure activity of the muscles~        -  Motorized, robotic, and electrical stimulation of the muscles~        -  Other clinical tests of muscle movement as needed.~        -  Participants with cerebral palsy will have biofeedback sessions. These sessions will~          help them learn to coordinate muscle movement and brain activity.~   "
93773|NCT01829711|"~     Background:~      - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It~     targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells.~     Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills~     the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with~     safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053).~     This is a phase III multicenter trial designed to confirm these results.~   "
93774|NCT01829698|"~     Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical~     effectiveness of UDCA may be limited by its poor absorption and extensive~     biotransformation.The more hydrophillic bile acid tauroursodeoxycholate (TUDCA) is the~     active ingredients of UDCA,and has been approved by state food and drug administration in~     China for treatment of cholesterol stones.So it is necessary to verify the efficacy and~     safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized,~     double-blinded, double -dummy, parallel-controlled and multicenter clinical trial, we detect~     the proportion of patients who had AKP decline more than 25% as the primary outcome;decline~     of ALP,total bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated~     with TUDCA or UDCA for 24 weeks.~   "
93775|NCT01829685|"~     The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0~     mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B~     patients with inadequate response to NUC therapy~   "
95884|NCT01802099|"~     The purpose of this study is to assess the hypothesis that, as compared to early intravenous~     feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality~     in critically ill patients treated with mechanical ventilation and vasoactive drug.~   "
93776|NCT01829672|"~     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of~     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT).~     In this prospective study the investigators validate DE-CT results of patients against~     hemodynamic parameters from right heart catheterisation and control the results by other~     clinical investigations. The investigators expect that using this non-invasive method,~     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,~     blood flow and perfusion heterogeneity, can be determined.~   "
93777|NCT01829659|"~     This study is being done to assess the effects of the CTP inhibitor on the function of your~     platelets (cells within your blood that are involved in the formation of blood clots) and to~     assess whether you have responded to the ticagrelor well enough to prevent the formation of~     blood clots within the stent or site in which angioplasty was performed.~      Recent studies have looked at how racial differences can affect platelet reactivity, the way~     blood clots. But these studies have not looked at the way different racial backgrounds can~     affect the way the blood forms clots. Minorities, such as African-Americans are~     underrepresented. Therefore, we are conducting this platelet reactivity study to better~     understand if there are differences in how this drug affects African-Americans from how they~     affect Caucasian patients undergoing percutaneous coronary intervention and receiving~     ticagrelor. These data will be compared to a historical control of Caucasian patients who~     underwent similar platelet function testing.~   "
93778|NCT01829646|"~     Despite uniform histopathological definition the response of locally advanced squamous cell~     carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with~     locoregional recurrences burdening this patient population. The addition of concurrent~     chemotherapy and the use of altered fractionation schedules has significantly increased~     locoregional control and overall survival over the last decade however, this has come at the~     cost of increased acute and late toxicity, preventing further treatment intensification in~     all patients. If the investigators want to increase the therapeutic index of HNSCC, we need~     to be able to tailor the treatment more individually to each patient. The project aims at~     developing a prognostic model for head and neck cancer patients based on the combination of~     known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters~     derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging~     (MRI) obtained before and during treatment. The investigators plan a prospective trial where~     120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will~     be included. Prior to treatment biopsy material will be collected for genetic analysis and~     before and during treatment functional MRI with diffusion weighted and dynamic contrast~     enhanced imaging will be performed. All patients will be followed up multidisciplinary~     afterwards with follow-up of tumor status and toxicity.~   "
93779|NCT01829633|"~     Study population: Patients who have been treated with physiotherapy for a potentially~     repairable rotator cuff tear in the period from 2002 to 2005.~      Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined~     clinically, sonographically and by MRI. Some patients also completed a shoulder score. All~     study patients will now be reexamined, 8 to 10 years after they were diagnosed.~     Reexamination includes history taking, clinical examination, completion of three shoulder~     scores (two shoulder specific scores, one general health score), Sonography and MRI.~     Findings of interest are~        -  the number of relapses during follow-up,~        -  the need for surgical treatment during follow-up,~        -  the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration)~          during follow-up~        -  the actual clinical shoulder condition (as given by shoulder scores) at reexamination.~      Study purpose: We want to assess the anatomic and clinical long-term results of~     physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear~     anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration~     is associated with a development of more serious degrees of symptoms.~   "
93780|NCT01829620|"~     The investigators propose to utilize text messaging to create and investigate the efficacy~     of a Continuing Contacts via Text (CCVT) intervention that extends the continuity of care~     for Service Members with a recent suicide attempt and/or reported suicidal ideation by~     sending them non-demanding caring text messages at regular intervals over a 12-month period.~     Participants will be randomly assigned to receive Continuing Contacts via Text (CCVT) in~     addition to Treatment as Usual (TAU) or TAU alone.~      Aim 1: To determine if the addition of 12 months of CCVT to TAU (CCVT+TAU) results in lower~     rates of suicidal ideation and behavior relative to TAU alone.~        -  Hypothesis 1a: Participants assigned to CCTV+TAU compared to TAU alone will experience~          reduced suicidal ideation at 12-month follow-up.~        -  Hypothesis 1b: Over the 12 months following study enrollment, a smaller proportion of~          participants assigned to CCVT+TAU vs. TAU alone will have suicide risk incidents (i.e.,~          those requiring medical evacuation or hospital admission).~        -  Hypothesis 1c: Over the 12 months following study enrollment, CCVT+TAU vs. TAU alone~          will have fewer total number of suicide risk incidents requiring medical evacuation or~          hospital admission.~      Aim 2: To test two proposed mechanisms of action of CCVT outcome: 1) reduced thwarted~     belongingness and 2) increased engagement in behavioral health services.~        -  Hypothesis 2a: The effect of CCVT+TAU compared to TAU alone will be mediated by~          reductions in thwarted belongingness from pre to post-study.~        -  Hypothesis 2b: The effect of CCVT+TAU compared to TAU alone will be mediated by~          increased use of outpatient behavioral health services in the CCVT+TAU condition.~   "
93781|NCT01829607|"~     The purpose of this study is to evaluate the effects of functional electrical stimulation of~     peripheral muscles on clinical and emotional status, endothelial function and left~     ventricular diastolic function in heart failure with preserved left ventricular ejection~     fraction.~   "
93782|NCT01829594|"~     The aim of is to test the effects of a model for care (case management) to older people with~     high healthcare consumption and functional dependency on healthcare consumption, quality of~     life, functional ability and experiences of care.~   "
93846|NCT01828762|"~     Although liver resection, liver transplantation, a-interferon, Transarterial Chemo~     Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave~     coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients~     with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety~     of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients~     Following Resection and TACE Therapy will be evaluated.~   "
93783|NCT01829581|"~     Intracerebral hemorrhage [ICH] is the most feared complication of anticoagulant therapy~     [OAC]. Evidence regarding acute therapeutic interventions as well as secondary treatment~     approaches is still limited. Therefore, this German-wide observational cohort study will~     retrospectively identify and evaluate all OAC-associated ICH patients that have been~     admitted to the 20 participating tertiary centres over a 5-year period. The main focus of~     this investigation, besides epidemiological aspects, will be the (i) acute management of~     OAC-ICH, (ii) secondary therapy (anticoagulant management) and (iii) long-term outcome after~     OAC-ICH.~   "
93784|NCT01829568|"~     This phase I clinical trial studies the side effects and best dose of lenalidomide and~     ibrutinib when given together with rituximab in treating patients with previously untreated~     stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different~     ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can find cancer cells and help kill them. Giving lenalidomide and ibrutinib~     together with rituximab may work well in treating follicular lymphoma.~   "
93785|NCT01829555|"~     Glucose control is necessary to avoid the immediate and long-term adverse effects associated~     with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important~     step to achieving glucose control. Data suggest that large proportions of adolescents and~     young adults fail to adhere to standard guidelines of self-monitored of blood glucose~     testing and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can~     lead to increased risk of medical complications over an individual's lifespan, necessitating~     novel interventions to improve self-monitored blood glucose testing and metabolic control in~     emerging adults with type 1 diabetes. The investigators treatment approach, which provides~     direct tangible reinforcement for objective evidence of behavior change, is efficacious in~     decreasing substance use, reducing weight, and improving medication adherence.~      The purpose of this project is to develop and pilot test an intervention based on behavioral~     economic principles for improving self-monitored blood glucose testing in young persons with~     type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they~     test, and a return text will inform them of reinforcer vouchers earned. The investigators~     will collect data on self-monitored blood glucose testing frequency and A1c levels preceding~     treatment initiation and throughout a 6 month treatment period. If promising, a randomized~     trial will lead to larger scale evaluations of reinforcement interventions alone, or in~     combination with multimodal treatment approaches, and it may be applied to other clinical~     issues such as adherence to continuous glucose monitoring. Importantly, this intervention~     can be administered remotely and in an automated fashion, allowing for widespread adoption~     if efficacious.~   "
93786|NCT01829542|"~     The purpose of this study is to assess the impact of acute blueberry polyphenol intake on~     endothelial function of healthy volunteers. Specifically, the investigators plan to perform~     a randomised, double blind, cross-over human intervention trial using a blueberry drink to~     investigate the dose-dependent effects of blueberry polyphenols on blood vessel function~     using Flow mediated dilation (FMD) to measure endothelial function. The study will not only~     measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess~     plasma polyphenol metabolite levels.~   "
93787|NCT01829529|"~     The hypothesis of the present study is that quantitative and qualitative oral microflora~     alterations and changes in antibiotic susceptibility among oral commensal microflora will~     occur following a single dose administration of amoxicillin.~   "
93788|NCT01829516|"~     This is a randomized, placebo controlled, double blind crossover study of the effects of~     intranasal oxytocin on social cognition, implicit preferences and craving in moderate to~     heavy social alcohol drinkers.~   "
93789|NCT01829503|"~     Primary objective: To determine the efficacy of an induction regimen using decitabine as an~     epigenetic primer followed by cytarabine in the treatment of older patients with newly~     diagnosed Acute myeloid leukemia (AML).~      Primary endpoint:~      Complete remission rates~      Secondary objective: To determine the safety of an induction regimen of decitabine followed~     by cytarabine in the treatment of older patients with newly diagnosed AML, evaluate survival~     and identify potential predictive factors for response to treatment~      Secondary endpoints:~        -  Treatment related toxicities~        -  4 and 8 week mortality~        -  Overall survival~        -  Relapse-free survival~        -  Predictive factors for response to treatment~        -  Quality of Life measures including self reported symptoms and assessment of sleep~          patterns~      Treatment administration~      Induction therapy Eligible patients will be treated with induction therapy (decitabine +~     cytarabine) at the University of Pittsburgh Cancer Center inpatient leukemia service at~     Shadyside Hospital. Patients will receive decitabine 20mg/m2 in 100mL normal saline (NS)~     intravenously (IV) over 1 hour daily for five days, followed by cytarabine 100mg/m2 in 1000~     mL normal saline (NS) as a continuous IV infusion over 24 hours for 5 days. Treatment should~     be discontinued or delayed for any of the following during the treatment period: a rise in~     serum creatinine > 2x patient baseline or upper limit of normal (whichever is higher) unless~     there is an identifiable reversible etiology, or ALT, AST or total bilirubin > 5x upper~     limit of normal, and should be held until resolution below these parameters. There are no~     parameters for dose reduction.~      Patients who have persistent disease on post-treatment bone marrow aspirate and biopsy, will~     undergo a repeat cycle of induction with decitabine followed by cytarabine as outlined~     above.~      Supportive care including blood product transfusions, antiemetic medications antiviral and~     antifungal medications, or empiric antibiotics may be used at the clinical discretion of the~     provider.~      Maintenance therapy Patients in complete response (CR) will proceed to decitabine~     maintenance therapy, where each treatment will be decitabine 20mg/m2 in 100mL normal saline~     (NS) intravenously (IV) over 1 hour daily for five days administered in the outpatient~     setting. Maintenance treatments will be continued until disease relapse. Maintenance~     treatments can be administered as an outpatient at the Hillman Cancer Center, or at a~     University of Pittsburgh Medical Center (UPMC) facility that is able to administer~     chemotherapy under the supervision of an Oncologist~      Evaluations during maintenance Phase:~      During maintenance therapy, complete blood count (CBC) w/ diff/platelets, CMP (Na, K, Cl,~     carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), Cr, Ca, Total Protein, Albumin,~     AST, ALT, Alk Phos, Total Bilirubin) will be checked each cycle on day 14 [+/- 4 days].~      Within 7 days of start of new cycle, study visits will include physical exam, adverse events~     assessment, CBC and comprehensive metabolic panel (CMP).~      Maintenance cycles will be 28 days [+/- 7 days]. Cycles can be held up to 4 weeks [28 days].~     For start of new cycle, any grade 3 or 4 non-hematologic toxicity possibly, probably or~     definitely related to decitabine therapy must resolve to grade 2 or baseline.~      In addition the following lab parameters must be met to start a new cycle of maintenance:~      Absolute Neutrophil Count (ANC) > or = 1000/mm3 Platelets >/= 50,000/mm3 AST or ALT < 2 x~     Uppler Limit of Normal (ULN) Total billirubin < 2 x ULN Serum creatinine < 2x patient~     baseline or upper limit of normal (whichever is higher)~      [If lab parameters are not met for start of cycle, these labs will be checked a minimum of~     once per week]. If start of new cycle is held for more than 4 weeks [28 days], the subject~     will be off treatment.~      Other reasons for delay in treatment should be discussed with the Principal Investigator.~   "
93790|NCT01829490|"~     This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A~     vaccination with and without MVA85A boost in healthy BCG vaccinated adults.~   "
93791|NCT01829477|"~     The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on~     glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in~     addition to diet and exercise.~   "
93792|NCT01829464|"~     The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination~     with sitagliptin on glycemic control in adults with type 2 diabetes.~   "
93793|NCT01829451|"~     The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion~     formation after endometrial thermal ablation.~   "
93794|NCT01829438|"~     To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred)~     on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen~     saturation) in healthy children.~   "
93795|NCT01829425|"~     This study is randomized controlled trial in which urgency incontinent women (approximately~     150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6~     &12; a subset of women will have pre-treatment brain activation and connectivity compared to~     controls using functional magnetic imaging (fMRI) with 2 month post-treatment brain~     activation and connectivity compared to pre-treatment in the UUI subset using fMRI.~      Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy decreases~     abnormal perception of bladder distension outside the hypnotic state and is at least as~     effective as pharmacotherapy in diminishing symptoms of urgency and severity of UUI. On fMRI~     in UUI, hypnotherapy will decrease hyper-activation of brain areas in response to bladder~     distension and/or modulate functional connectivity within the brain. Normalization of~     hyper-activation and connectivity will be greater in hypnotherapy compared to~     pharmacotherapy. Additionally, women who have greater improvement in UUI will have greater~     normalization of hyper-activation and connectivity on fMRI. UUI participants will exhibit~     increased activation within portions of the brain and abnormal functional connectivity~     relative to controls.~   "
93841|NCT01828827|"~     This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment,~     two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the~     pharmacokinetics of PA-824. This study was designed to understand the possible effects of a~     high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be~     tested in this study is that the rate and extent of absorption of PA-824, as measured by~     Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as~     compared with after a minimum 10-hour fast.~   "
93796|NCT01829412|"~     Bone disease in multiple myeloma (MM) is routinely assessed by skeletal X-ray (XR) and~     magnetic resonance of the spine (S-MRI). Diffusion-weighted MRI (DW-MRI) is a functional MRI~     that detects water diffusion through cells. This prospective phase II study compared~     whole-body DW-MRI with XR and S-MRI for the assessment of MM bone lesions.~      METHODS. Thirty-six consecutive symptomatic patients at diagnosis or at relapse performed~     XR, S-MRI, whole-body MRI, and whole-body DW-MRI before treatment, after treatment, and 6~     months after treatment. A substudy evaluated 12 asymptomatic patients at diagnosis, after 6~     and 12 months. Radiology exams were independently read by 3 experienced radiologists, and~     the techniques were compared by the count of segments with focal lesions (FL) (>=5mm).~   "
93797|NCT01829399|"~     Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq)~     pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary~     anesthetic for surgical procedures on the upper extremity. The aim of this study is to~     determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper~     arm just distal to axillary crease will significantly diminish Tq pain. If it does,~     peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as~     the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve~     blocks have fewer complications than brachial plexus blocks performed at higher levels, and,~     postoperatively, the patient has better control of his or her arm when distal nerve blocks~     are used.~      Procedures (methods): This is a prospective, cross-over study to examine the effectiveness~     of an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This~     Subcutaneous ring of local anesthetic is often referred to as Intercostobrachial nerve~     block or Subcutaneous ring anesthesia (SRA). Twenty volunteers will be randomized into~     four groups of 5 participants each. During the initial experiment, the first group will be~     given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant~     arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine~     1:200,000 on their non-dominant arm, the third group will be given sham SRA with saline on~     their dominant arm, and the fourth group will be given sham SRA with saline on their~     non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the~     subcutaneous injection and it will be inflated to 100 mm Hg above the subject's baseline~     systolic blood pressure. We will monitor heart rate, blood pressure (opposite arm) and pain~     (0 to 10 VAS) every 5 minutes. Each Tq will be released when the subject requests deflation~     or when 1 hour of Tq time has elapsed, whichever occurs first. The subject's discomfort~     level (VAS) just prior to deflation will be recorded. Since Tq pressure alone can inhibit~     nerve function, we will monitor motor and sensory function distal to the Tq every 10 minutes~     during Tq inflation and for 30 minutes after Tq deflation. One to two weeks after this~     initial study, the same 20 subjects will receive SRA on the same arm and the same parameters~     will be measured. The 10 subjects who received 0.25% Bupivacaine the first time will receive~     Normal Saline, and the 10 subjects who received Normal Saline the first time will receive~     0.25% Bupivacaine. In this way, each subject will act as his or her own control.~   "
93798|NCT01829386|"~     To determine if MRI imaging can be used to determine the amount of iron in areas of the~     brain affected by a stroke, which may help in the future to see if this can predict the~     amount of brain damage and therefore the effects on the patient. New research treatments are~     being used to reduce the amount of iron build up in the brain; the effects of that treatment~     may also be seen using new MRI techniques.~   "
93799|NCT01829373|"~     This study tests the ability of the allogeneic cellular vaccine 1650-G vaccine to enhance~     immune recognition of tumor cells in patients with lung cancer. The vaccine is combined with~     an oral medication called beta glucan, an over the counter oral dietary supplement that may~     also stimulate the immune system in ways that helps the body eradicate cancer cells and~     reduce risk of recurrent cancer. The primary purpose of this study is to measure the changes~     in the number of immune cells that might help lower risk of cancer recurrence. The~     investigators do not yet know if the vaccine is effective in fighting cancer and will not~     know at the end of this study whether this has been of benefit.~   "
93800|NCT01829360|"~     This research attempts to adapt and optimize a word learning treatment, specifically~     interactive book reading, for use with Kindergarten children with Specific Language~     Impairment (SLI). Children with SLI have difficulty learning language without any obvious~     cause for this difficulty. Two treatment studies will be conducted to determine (1) the~     number of times children with SLI need to hear new words during book reading to learn the~     new words; (2) the best way to provide the target number of exposures to new words during~     book reading. For example, is it better to hear the new words many times within the book and~     to read the book few times, or is it better to hear the new words a few times within the~     book and to read the book many times. The investigators hypothesize that children with SLI~     will need to hear new words 2 to 3 times as often as children with normal language to learn~     the words and that reading the books many times will be more effective than repeating the~     words many times within a book.~   "
93801|NCT01829347|"~     The purpose of this study is to determine if treatment with the ELAD System is safe and~     effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille~     score >0.45).~   "
93802|NCT01829334|"~     The aim of this proposed study is to investigate the cost-effectiveness of four methods in~     preventing fissure caries in permanent teeth, which is the most prevalent dental disease in~     primary school children in China.~      The four caries prevention methods are: resin fissure sealant, atraumatic restorative~     treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF)~     solution.~      The specific study objectives are:~        1. to describe longitudinally the clinical outcomes of using the above four methods to~          prevent dental caries in the pits and fissures of permanent first molars in school~          children,~        2. to describe the cost of using the above four methods to prevent dental caries in an~          outreaching dental care programme in China, and~        3. to compare the cost-effectiveness of the above four caries prevention methods.~   "
93803|NCT01829321|"~     -  Approximately 45 patients suffering from mild to moderate ulcerative colitis will be~          examined for any side effects (safety and tolerability) that may occur when taking~          GLPG0974 or matching placebo (2:1 ratio) for 28 days.~        -  During the course of the study, patients will also be evaluated for improvement of~          disease activity by different efficacy measures, the amount of GLPG0974 present in the~          blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the~          blood, colon biopsies and faeces will be explored.~   "
93804|NCT01829308|"~     The purpose of this study is to examine the implementation of two evidence-based~     intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol,~     tobacco, other drug use, and HIV risk behaviors.~   "
93805|NCT01829295|"~     In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the~     investigators propose to establish which immunosuppressive therapy, methotrexate or~     mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for~     the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative~     effectiveness trial.~   "
94040|NCT01826201|"~     The purpose of this study is to determine whether MOL4239 is effective in adult subjects~     with mild to moderate plaque psoriasis by comparing two target lesions in which each subject~     will apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral~     target lesion twice a day for 28.5 consecutive days.~   "
93806|NCT01829282|"~     This study focuses on the implementation of an evidence-based HIV risk reduction~     intervention for HIV-serodiscordant, heterosexual African American couples (Eban II) in~     two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles~     Counties) that have a high prevalence of HIV infection and risk conditions among African~     Americans.~      The Specific Aims are as follows:~        1. To evaluate implementation of Eban for HIV serodiscordant African American couples in~          10 CBOs in California. To do this, we will document the implementation process and~          identify barriers and facilitators to Eban's adoption and use by the CBOs. We will~          interview 200 staff at CBOs to obtain this information.~        2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples,~          specifically incidents of protected sex, proportion of condom use, and incident~          sexually transmitted infections. Eban will be assessed using a randomized delayed~          enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at~          posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and~          offered to couples and evaluated for effectiveness - that is, how well it works in the~          real world.)~        3. To determine the cost-effectiveness of implementation of Eban, based on implementation~          costs and potential cost savings.~   "
93807|NCT01829269|"~     The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5~     years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a~     higher complication rate than average. We will therefore be increasingly confronted with~     faulty sensors or at risk to be replaced.~      There are no standardized approach for replacing defibrillation lead. A record made in the~     United States showed significant differences according to the teams strategy in case of~     failure of defibrillation lead in particular with regard to the decision to explant or~     abandon the probe.~      The risk of extracting a defibrillation lead are well known with a major complication rate~     of 1.6 to 1.95%.~      Regarding the risk of complications related to the abandonment of a probe we have less data.~     For some there is no risk to abandon a defibrillation lead. But others reported a~     complication rate of 5.5% related to pacing discontinued.~      Main objective: Collect the attitude of different centers and different operators when~     replacing a failed defibrillation lead or at risk. Explantation or abandonment of the~     sensor replaced.~   "
93808|NCT01829256|"~     Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and~     death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United~     States. The purpose of this study is to prevent progression of kidney disease among patients~     with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that~     simultaneously address medication management and modifies multiple risk factors through a~     combination of patient self-monitoring, behavioral therapies and education to optimize~     adherence and self-efficacy. Additional goals are to improve control of cardiovascular~     disease risk factors and reduce cardiovascular events and death.~      We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention~     will have less progression, or a smaller decrease in kidney function, after 3 years when~     compared to the education control group.~   "
93809|NCT01829243|"~     This study was designed to investigate whether milnacipran is safe and effective in~     improving cognitive function in fibromyalgia. In addition, this study was aimed to~     investigate whether improvement in neurocognitive status due to milnacipran correlates with~     improvements in pain, to investigate whether improvement in neurocognitive status due to~     milnacipran correlates with improvements in fatigue, and to determine whether treatment with~     improvement in neurocognitive status, pain and fatigue correlates with functional~     improvement.~   "
93810|NCT01829230|"~     This is a continuation study for subjects who were previously fit with test or control~     lenses; all will stop wearing their study lenses assigned in the previous study and will~     start to wear an FDA-approved marketed spherical soft contact lens.~   "
93811|NCT01829217|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved sunitinib for your type of cancer.~      Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors,~     advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most~     chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking~     certain protein signals within the cell. Because sunitinib works differently from standard~     intravenous chemotherapies, we call it a targeted therapy. This drug has also been used in~     other research studies and information from those other research studies suggests that this~     agent may help to slow the growth of some NSCLC tumors.~      In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors~     from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously~     been found to be more sensitive to other kinds of oral targeted therapies. This study will~     focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known~     cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100~     cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET~     gene.~   "
93812|NCT01829204|"~     The purpose of this study is to identify and elucidate the pattern and perhaps role of~     atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms~     involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and~     preterm labor.~   "
93813|NCT01829191|"~     This study is to investigate whether novel soft contact lens optical designs can slow myopia~     progression~   "
93842|NCT01828814|"~     Options for large-scale preventive distributions include fortified blended flours,~     ready-to-use foods and direct cash transfer either alone or in combination with family~     protective rations. Finding the most appropriate strategy is essential to prevent child~     malnutrition in countries like Niger with annual hunger gaps. Here, the investigators~     compare different preventive strategies on the incidence of acute malnutrition among~     children 6 to 23 months.~   "
93843|NCT01828801|"~     The purpose of this clinical study is to evaluate blood metal ion levels as a function of~     time of implantation for the Pinnacle Acetabular MoM system.~   "
94041|NCT01826188|"~     There are many reports about efficacy of Cannabis in Crohn's disease but no controlled~     trials. The aim of the proposed trial is to investigate the efficacy of oil containing the~     cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.~   "
93814|NCT01829178|"~     Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid~     tumours. acute renal failure, despite conservative fluid and electrolyte management,~     frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan~     complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective,~     anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated~     lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to~     cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor,~     vascular endothelial growth factor and insulin-like growth factor-I have shown in the~     previous in-vitro studies.The aim of present study,a randomized double-blind placebo-~     controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin~     induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed~     upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus~     chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21~     days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and~     urine electrolyte will be measured daily during chemotherapy.~      changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity~     assessed up to 64 days.~   "
93815|NCT01829165|"~     The overarching goal of this research program is to elucidate causal and directional neural~     network- level abnormalities in depression, and how they are modulated by an~     individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the~     investigators can overcome a major limitation of neuroimaging - the inability to demonstrate~     causality. The investigators' findings will serve as a platform for future studies wherein~     TMS treatment can be directly guided by the investigators' ability to image and causally~     manipulate specific neural networks.~      Aim 1: To examine causal interactions between two major brain networks in depression.~      Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in~     depression.~      Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls,~     in two targeted and interacting networks, using concurrent transcranial magnetic stimulation~     (TMS) and functional magnetic resonance imaging (fMRI).~      Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in~     normalization of baseline network-level deficits, and be predicted by degree of baseline~     network abnormalities.~   "
93816|NCT01829152|"~     The primary objective is to evaluate the impact on heart failure related quality of life~     when integrating a mobile health system, Verizon Wireless's Converged Health Management~     (CHM), into a subject's self-management of their heart failure (HF) as well as in the~     medical management of HF by the subjects' clinical team.~   "
93817|NCT01829139|"~     In patients with gallbladder in situ after complete removal of common bile duct (CBD)~     stones, there is no definite guideline for the management of remnant acalculous gallbladder.~     This study was planned to evaluate the efficacy of choleretic agents in those patients~     comparing with non-treatment group during short (2 years) and long-term (5 to 10 years)~     period. So that, the investigators want to establish the treatment guideline in gallbladder~     in situ without definite stones following complete removal of CBD stones. Second, the~     protective or preventive effect of choleretics may be defined.~   "
93818|NCT01829126|"~     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the~     skin and all internal organs. Cardiac involvement, mainly characterised by small~     intramyocardial coronary artery involvement and myocardial fibrosis, can cause the~     development of impaired diastolic ventricular filling, cardiac blocks and ventricular~     arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug~     has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based~     level. Short-term trials and retrospective studies have suggested a favourable and~     protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors~     in patients with myocardial involvement. However, no data are presently available on the~     prevention and treatment of severe heart disease.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis. Aim of this~     observational trial is to assess the efficacy and safety of calcium channel blockers and~     angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac~     involvement.~   "
93819|NCT01829113|"~     This randomized phase II study will compare the efficacy and safety of the combination of~     carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated~     advanced non-squamous NSCLC.~   "
93820|NCT01829100|"~     Psychological therapies for depression have demonstrated efficacy, but outcomes are still~     unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur~     in up to 69-75% of teens and intensify functional impairment and service use. This study~     will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy~     (GBAT) and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade~     boys and girls with co-occurring depression and anxiety. Multi-reporter, multi-domain~     assessments will be conducted at initial screening, pre- and post-treatment, and 4-month~     follow-up. BA is a straightforward, but flexible and robust, therapy that has demonstrated~     strong results in adults. Current formulations of BA highlight the specific role of~     avoidance in depressotypic behavior. It presumes that anhedonia, isolation, and negative~     behaviors associated with depression function to avoid imminent distress even as it blocks~     access to otherwise available positive reinforcement. This study will therefore employ novel~     electronic diary technology to obtain Ecological Momentary Assessment and evaluate: (a) the~     function of avoidance in distinguishing youth with depression (n=35) from a non-clinical~     comparison group (n=18), and (b) the role of avoidance in mediating treatment gains in~     participants in the GBAT intervention.~   "
93821|NCT01829087|"~     The goal of this research project is to evaluate injections of botulinum toxin A (Botox) as~     the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current~     treatment for patients who do not achieve full extension of the knee (flexion contracture)~     after TKA consists of an aggressive physical therapy program, home stretching program, and~     the use of an extension orthosis (brace). Many patients do not tolerate wearing these~     braces. This initial project is designed to use injections of Botox as an adjunct to the~     standard current treatment and evaluate its efficacy. It is our hypothesis that a single~     injection into the hamstrings in addition to routine postoperative rehabilitation will~     result in improved knee extension and this improvement in function should endure without~     further treatment.~   "
93822|NCT01829074|"~     Acid reflux can cause many symptoms in the throat, including discomfort or pain, and~     difficulty with breathing and voice problems. Doctors have different ways of diagnosing and~     treating the reflux that causes these symptoms, and they are trying to better understand~     what the best ways are to treat the patients with these symptoms.~      Usually, a doctor will prescribe medication for reflux based on the symptoms a patient~     complains of. Sometimes it works and the patient gets better, sometimes it does not work and~     the patient's condition does not improve. The doctor will also use findings from an~     examination with an endoscope in the patient's throat to see if there is any damage that~     might have been caused by reflux. One new device that doctors use to help them diagnose~     reflux has a sensor on the end of a tube that goes through the nose and rests in the throat.~     This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux~     occurs.~      The study doctors are performing this research study to help them understand more about acid~     reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.~      The study involves procedures, medications and devices that are already used regularly in~     doctors' offices and hospitals. The experimental part of this research is blinding the study~     doctor to the results of the pH study until the end of a three month course of antireflux~     medication, and performing a second pH study to measure change in acid exposure.~      Hypothesis: The Restech pH study helps identify patients who will respond positively to acid~     inhibitory therapy, and patients whose study normalizes will have better Symptomatic~     response rates than those whose pH levels fail to normalize.~   "
93823|NCT01829061|"~     The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the~     in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained~     from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is~     indicated in the management and treatment of diabetes and for monitoring long term glycemic~     control by diabetics. It is for multiple patient use. Only auto-disabling, single use~     lancing devices should be used with this system.~   "
93824|NCT01829048|"~     To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally~     to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/-~     other adjunctive medication.~   "
93825|NCT01829035|"~     This is a randomized, multi-center, open-labeled, phase III study in patients with advanced~     HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to~     receive sorafenib with (Arm Combination-treatment; Arm C) or without (Arm Sorafenib alone~     treatment; Arm S) cTACE.~      All the patients will be initially given sorafenib within 72 hours after the randomization.~     Treatment should continue until the criteria for treatment discontinuation are met.~      After the treatment period, patients will undergo follow up for survival every 12 weeks (±7~     days) from the last dose, and the survival follow up will be performed for at least 1.5~     years after the last patient's last treatment.~   "
93826|NCT01829022|"~     Primary objectives : To investigate technical feasibility and postoperative morbidity after~     E-NOTES for Myomectomy with Traction of Multidirectional Sutures~      Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with~     Traction of Multidirectional Sutures by clinical variables such as incision size, type of~     port, size and number of myoma, or operation time.~   "
93827|NCT01829009|"~     Aging is characterized by a progressive loss of multiple physical and cognitive abilities.~     From these changes, the most important one is the loss of muscle mass, which has been called~     sarcopenia. Resistance exercise is a therapeutic approach for sarcopenia, nevertheless~     there is no universal consensus. Therefore, this research is interested in determining the~     effect of a resistance exercise program on physical performance and/or functional status in~     sarcopenic older women. The main study hypothesis is that a program of resistance exercise~     will improve physical performance and functional status in sarcopenic older women compared~     against general recommendations.~      This is a single-blind, controlled clinical trial, including women> 70 years, living in the~     community with sarcopenia. Those who agree to participate, will be randomly assigned to one~     of the following groups:~        1. Resistance Exercise Group~        2. General Recommendations Group (control) The study will last 24 weeks, with 4~          measurements performed at baseline, week 6, 12 and 24. Multilevel models (random~          effects) will be constructed for the comparison between the two groups. Tests will be~          conducted with a P=0.05 and confidence intervals at 95%. This protocol has been~          approved by the local ethics committee.~   "
93828|NCT01828996|"~     Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis~     and accounts for approximately 2 million outpatient visits to urology practices in the~     United States alone. Up to 6% of men in Canada recently experienced at least moderate to~     severe prostatitis-like symptoms with two thirds having symptoms lasting more than one year.~     There are a myriad of therapies for prostatitis, some of which work on some of the men but~     none works for all the men. Recently, a number of centres have been using low energy shock~     waves applied on the skin to target the prostate and the muscles around the prostate. The~     initial reports showed a significant reduction in the pain experienced by the men with~     prostatitis. However, this potentially highly promising therapy has not been widely used at~     least in part due to a lack of properly designed studies to validate this therapy. The~     investigators plan a randomized control trial using shock wave therapy on men with~     prostatitis. The goal is to provide some solid evidence that either shock waves are or are~     not of clinical benefit.~      The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome~     will have a reduction in pain and improved voiding and sexual function following low power~     transdermal shock wave therapy to the prostate and surrounding pelvic muscles.~   "
93844|NCT01828788|"~     Postoperative pain after cardiac surgery is a risk factor for postoperative complications.~     In cardiac surgery, pain is more intense during the first 48 hours and disturbs the~     patient's capacity of coughing, deep breathing, and early mobilisation. It may be~     responsible for respiratory complications such as bronchial or pulmonary infection, and may~     also delay the patient's rehabilitation and therefore prolong the duration of in-hospital~     stay. A previous pilot study performed in our department showed a sensible improvement of~     analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of~     local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be~     tested in a subpopulation of patients at risk for respiratory complication.~   "
93829|NCT01828983|"~     Deployment impacts both service member and family, and the cost can be high. Spouses'~     reactions to deployment may include emotional distress, loneliness, anticipatory fear or~     grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage~     stress and solve problems related to deployment and reintegration, communication, managing~     long distance relationships, and other common problems. The study will compare telephone~     support groups to online education sessions. The study will enroll 160 spouses. In the~     Telephone Support groups, a group leader and participants will meet 12 times over six months~     to focus on education, skills building and support. Education Only online sessions will~     provide the same education content, without skills building or support. Content includes~     strategies to reduce or eliminate communication difficulties during deployment, how to find~     help; practical concerns during deployment; fostering resilience and decreasing stress;~     fostering relationships while apart, negotiating roles and relationships; changes during~     deployment; strategies to support the spouse and the service member; and cues to alert~     spouses when to seek mental health services for the family or themselves. Outcomes will~     include resilience, depression, anxiety and coping behaviors. Telephone data collection will~     be conducted at baseline, six and twelve months.~   "
93830|NCT01828970|"~     The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin~     regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed~     patients with diabetes~   "
93831|NCT01828957|"~     The objective of this study is to evaluate the efficacy and safety of a single intratracheal~     administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk~     premature infants by comparing Pneumostem-treated group with a control group.~   "
93832|NCT01828944|"~     The present project hypothesizes that the potential protective effect of olive oil relies on~     its polyphenols profile (quality and quantity) and that it may be synergistic to other food~     components. Among the nutrients that may be of interest for bone and muscle tissues,~     unsaturated fatty acids and vitamins are the most described.~      Consequently, based on the promising available preliminary data, the present project aims to~     investigate the possible preventive effect of olive oil polyphenols and eventually the~     synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in~     order to prevent any locomotor dysfunction.~      Volunteers will be supplemented during 9 months. The primary and secondary outcome measures~     will be performed at baseline, 3 and 9 months.~   "
93833|NCT01828931|"~     The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with~     psychotic illnesses than in the general population. Life expectancy of individuals with~     psychosis is also 20-25 years less than the general population, primarily due to premature~     onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic~     illness has been an exclusion criterion in all large-scale studies of diabetes prevention~     and management. We propose a 3-year randomized controlled trial examining the effectiveness~     of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical~     activity in overweight or obese individuals (N=150) suffering from both a psychotic illness~     and T2DM. Weight and glycemic control will be the primary outcome variables. It is~     hypothesized that a significant weight reduction and improvement in glycemic control will be~     found in those who receive the LI relative to those who do not.~   "
93834|NCT01828918|"~     Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients~     takes potential diagnostics, prognostics, and applications into consideration, especially~     the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic~     targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic~     therapy are the most important future clinical applications. CTCs measures may be useful to~     guide change in treatment decisions.~   "
93835|NCT01828905|"~     The aim of the study is to compare fracture healing, quality of life, pain, and cost of care~     of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous~     cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures~     treated by internal fixation and void reconstruction.~   "
93836|NCT01828892|"~     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of~     low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to~     compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG),~     commercial fibrin glue, and control therapy in the management of patients with low-output~     volume ECFs.~   "
93837|NCT01828879|"~     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in~     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very~     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic~     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease~     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in~     adult participants.~   "
93838|NCT01828866|"~     One interesting approach to the treatment of addiction is the use of Eye Movement~     Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the~     feasibility and efficacy of EMDR on addiction is limited and often lacks methodological~     rigor, the results are promising and suggest that further research on this subject is~     warranted.~      This proposal consists of two studies to test and determine the acceptability, feasibility~     and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol~     dependent outpatients as well as to gain further understanding in underlying working~     mechanisms.~   "
93839|NCT01828853|"~     This study aim to estimate maternal and neonatal outcomes after membrane sweeping in~     different group of patients.~   "
93840|NCT01828840|"~     The current study aim is to compare between the opioids morphine, fentanyl and methadone in~     terms of efficacy and side effects profile when administered epidurally for pain management~     after laparotomies. Intravenous morphine will also be used. The outcomes of that method will~     be compared to those obtained using epidurally administered opioids, as this is another~     commonly used postoperative pain relief method.~   "
93845|NCT01828775|"~     This pilot randomized clinical trial studies palliative care intervention in improving~     quality of life, psychological distress, and communication in patients with solid tumors~     receiving treatment on phase I trials. Cancer patients experience many symptoms related to~     treatment and the cancer itself that can be distressing and impact quality of life.~     Palliative care focuses on managing these symptoms and may help patients with solid tumors~     live more comfortably.~   "
93847|NCT01828749|"~     Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the~     last decade. However, the observed increases failed to reduce mortality or missed injury~     rates. Several investigators have derived (citation) and validated (citation) clinical~     decision rules that attempt to identify a subset of low risk pediatric and adult patients in~     whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to~     significantly reduce utilization. The investigators propose an alternative and complimentary~     strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the~     abdominopelvic CT in low risk patients. In stable, alert patients without clinically~     evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest)~     identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine~     abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically~     important decrease in radiation exposure. The study will investigate this by comparing the~     accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to~     detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures~     in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed~     clinically indicated by the treating clinician. Among those who have abdominopelvic CT~     scans, the study will determine the test characteristics of CT abdomen alone versus CT~     abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will~     include initial radiology reports, with structured follow up of indeterminate scans,~     operative reports, and 7-day medical record review.~   "
93848|NCT01828736|"~     A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of~     association of trastuzumab with combination chemotherapy in advanced or metastatic bladder~     cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may~     improve treatment efficacy on tumours overexpressed HER 2.~   "
93849|NCT01828723|"~     The primary purpose of this study is to demonstrate the safety of injecting the Stromal~     Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts~     into regions of the face that require enhancement. The safety of SVF will be evaluated~     throughout the course of the study phase through the assessment of laboratory values,~     physical examinations, adverse events, safety phone calls etc.~   "
93850|NCT01828710|"~     Many clinical evidences suggest that Myo-inositol plays a crucial role in human~     reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules~     was higher than in serum, and interestingly it was increasing through the epididymis and the~     deferent duct mining that sperm cell before ejaculation are stored in a medium highly~     enriched in myo-inositol.~      Starting from this evidences, the investigators hypothesized that myo-inositol may be a~     possible factor able to improve the semen parameters of samples used in in vitro~     fertilization cycles.~   "
93851|NCT01828697|"~     This is a randomized-controlled open-label trial comparing two different doses of~     low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous~     thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the~     American College of Chest Physicians (ACCP), but it is not known which dose is more~     efficacious in preventing recurrent venous thromboembolism in pregnancy.~      Patients enter the study and will be randomized as soon as a home test confirms pregnancy.~     LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months~     postpartum. Patients will be recruited by their treating physician, either an obstetrician~     or internist.~   "
93852|NCT01828684|"~     Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine~     sufferers report light sensitivity during a headache. Some people with migraine report that~     light can trigger their migraines and some people with migraine are light sensitive all of~     the time. The investigators have recently determined that certain colors of light are more~     likely to trigger migraines than other colors. In this study the investigators want to know~     if people who wear glasses that block these colors of light will have fewer migraine~     headaches.~   "
93853|NCT01828671|"~     Tortillas are a staple food in several cultures and are widely used to make tacos, burritos,~     and enchiladas. These foods are gaining a significant segment of the North American fast~     food and restaurant industry. From a health point of view, the addition of soy flour into~     corn tortillas will improve the nutritional profile of the tortillas and the presence of soy~     protein, dietary fibre and bioactive components has the potential to yield other health~     benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the~     glycemic index which could benefit those individuals with type 2 diabetes.~      The purpose of this research is to investigate whether different levels of soy flour in corn~     tortillas influences the glycemic response.~   "
93854|NCT01828658|"~     The investigators developed a prospective, randomized, controlled trial to compare strict~     volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus~     traditional clinical volume control in hemodialysis patients and the impact on mortality,~     hydration status, blood pressure values and arterial stiffness.~   "
93855|NCT01828645|"~     Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before~     anesthesia. These drinks are safe and are not associated to bronchial aspiration during~     anesthesia. The addition of protein may be beneficial for metabolic preconditioning but~     there is a few data in literature testing these drinks for safety. The aim of the study will~     be to investigate the residual gastric volume (RGV) measured during the gastroscopy with~     abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.~   "
93869|NCT01828463|"~     SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled,~     parallel group, dose-response study to investigate the effect of once daily nitisinone on~     24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks~     treatment. They study will identify the optimal dose to decrease urine homogentisic acid to~     near normal levels.~   "
93911|NCT01827904|"~     The objective of this prospective, randomized, double-blind (to subjects, local site's~     blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study~     (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of~     treatment using the ExAblate Transcranial System and to further demonstrate safety in~     medication-refractory tremor in subjects with essential tremor (ET).~   "
94056|NCT01825980|"~     To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability~     of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.~   "
93856|NCT01828632|"~     Background. Morbidly obese patients show an increased risk of hypoxemia and a higher~     incidence of postoperative pulmonary complications during the postoperative period resulting~     in prolonged hospital length of stay when compared with normal weight subjects. Preoperative~     respiratory physiotherapy including inspiratory muscle training (IMT) has been shown to~     reduce the incidence of post operative respiratory complications in some different settings.~      Objective. To determine wether a program of preoperative respiratory physical therapy could~     reduce the incidence and severity of postoperative hypoxemia in morbidly obese patients~     undergoing laparoscopic bariatric surgery.~      Setting. Hospital Clínico Universitario, Valencia, Spain.~      Design and Patients. A double-blind, randomized clinical trial. 50 patients (BMI≥40%)~     consecutively scheduled for laparoscopic bariatric surgery were included of whom 44~     completed the study. Sample size was calculated using the repeated measures of the PaO2/FiO2~     ratio along the postoperative period as the primary endpoint and considering an effect size~     of 0.25.~      Interventions. Patients were randomly assigned to receive either preoperative respiratory~     physical therapy (n=23) or usual care (n=21) during a month just before the date of surgery.~     Both groups received the same postoperative physical therapy.~      Measures. Data on oxygenation (primary outcome, PaO2/Fio2 ratio) were obtained at 1hour and~     at 12 hours after surgery. Data on spirometry and maximum static respiratory pressures~     (secondary outcomes) were obtained before and after the training period, and in the~     postoperative period.~   "
93857|NCT01828619|"~     The purpose of this study is to determine whether the new RIC regimen, containing of low~     dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged~     and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem~     cell transplantation.~   "
93858|NCT01828606|"~     Although there is no doubt about the need for compression therapy in lymphoedema, it is not~     investigated in much detail how much pressure is needed to get optimum volume reduction. New~     research suggests that there is obviously an upper pressure limit beyond further increase of~     pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure~     exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity.~     This study is designed to investigate the effect of pressure on %volume reduction of leg~     lymphoedema with 2 bandages which are very comparable in product properties (slippage,~     stiffness, etc.), but differ in their pressure exerted to the limb.~   "
93859|NCT01828593|"~     The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy~     serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI~     5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated~     enteropathy.~   "
93860|NCT01828580|"~     The main objectives of this study are to evaluate the safety and performance of the AutoLap~     system in Laparoscopic Cholecystectomy procedures.~   "
93861|NCT01828567|"~     The VA has committed to disseminate a web-based Healthy Living Assessment tool and use it as~     the cornerstone of a personalized prevention plan to engage patients to improve their health~     behaviors that lead to high health risk. Health risk assessments done in isolation, however,~     do not generally lead to behavior change. Our study will test the effectiveness of a Shared~     Decision Making intervention designed to activate Veterans to enroll in effective prevention~     programs. The intervention will be conducted over the telephone, by a prevention coach, and~     will be linked to the patients' primary care team. The co-primary outcomes will be patient~     activation and patient enrollment in prevention programs; 10-year risk of major cardiac~     events will also be measured.~   "
93862|NCT01828554|"~     The purpose of this research study is to find what happens to capecitabine in the body when~     dosed using actual versus ideal body weight in subjects with advanced tumors and elevated~     body mass index.~   "
93863|NCT01828541|"~     The purpose of this study is to determine whether hypnosis will decrease the intensity of~     either pain or itch in patients who have sustained a burn injury. Primary hypothesis:~     Hypnosis will provide more effective relief from post-burn itch and pain than a control~     intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.~      Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and~     fewer symptoms of Post Traumatic Stress Disorder (PTSD).~      Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the~     gabapentin doses and have lower average pain scores than those in the control group.~      Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early~     after injury will report lower rates of neuropathic pain and itch than subjects who will be~     enrolled in the study and receive hypnosis later in the healing process.~   "
93864|NCT01828528|"~     The purpose of this study is to investigate the effect of weight loss rate on liver~     steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and~     after bariatric surgery. The investigators also aim to study the short-term effect of~     bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric~     surgery.~   "
93865|NCT01828515|"~     The purpose of this study is to examine whether vilazodone attenuates the memory and mood~     effects of corticosteroids on the human hippocampus in 18 healthy controls.~   "
93866|NCT01828502|"~     RATIONALE: Providing parent/caregivers of children with cancer with education and evidence~     of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.~      PURPOSE: This randomized study will compare education only to education plus cotinine~     feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that~     reside with a household smoker.~   "
93867|NCT01828489|"~     This study evaluates the effect of different induction courses in children and adolescents~     with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to~     receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome.~     In the second course patients are randomised between standard treatment with ADxE~     (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine,~     cytarabine, DaunoXome).~   "
93868|NCT01828476|"~     The purpose of this study is to assess the effect of combining abiraterone with medicines~     that may block some of the ways that cells become resistant to abiraterone. The~     investigators hope that these combinations of medicines will result in prostrate cancer~     cells dying.~      This study will see if overcoming diseases resistance to abiraterone will restore~     sensitivity to androgen deprivation therapy.~   "
93870|NCT01828437|"~     Infantile spasms constitute a unique age specific epilepsy syndrome of infancy,~     characterized by epileptic spasms often accompanied by neurodevelopmental regression and an~     EEG finding of hypsarrhythmia. When all 3 components are present, the eponym West syndrome~     is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not~     respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the~     treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral~     steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in~     usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose~     prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been~     shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan,~     however there is paucity of data on the efficacy of combination of pyridoxine with hormonal~     therapy. There are no studies comparing add on pyridoxine with high prednisolone versus high~     dose prednisolone alone in the treatment of infantile spasms. Therefore the study has been~     planned to see whether the addition of pyridoxine with high dose prednisolone in the~     treatment of infantile spasms improves the efficacy in terms of spasm cessation.~   "
93871|NCT01828424|"~     There is a large variability of postoperative pain intensity and of the drug doses necessary~     to alleviate this pain. The investigators hypothesis is that a measurement of nociception at~     the end of surgery, using either the RIII reflex threshold, measures of heart rate~     variability or the pupil dilatation reflex measured by pupillometry, in relation to the~     doses of opioids used intraoperatively will yield a prediction of postoperative pain.~   "
93872|NCT01828411|"~     This prospective observational pilot study investigates transpharyngeal ultrasonography~     (TPU) as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump~     cardiovascular surgery.~      In the first part of the study the investigators will investigate the feasibility of TPU for~     visualization of aortic arch branches including the innominate and the carotid arteries in~     twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation~     (cohort 1.). In the second part the investigators plan to adopt the investigators previous~     experiences on TPU to a selected population of twelve patients undergoing ascending aortic~     and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to~     cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral~     perfusion stops or reductions due to surgical procedure, perfusion technique and their~     underlying disease (aortic dissection or aortic aneurysm).~      The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive~     technique provides a simple and real-time adjunct to assess blood flow velocity in the~     extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery~     with its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.~   "
93873|NCT01828398|"~     After stroke a limited motor recovery in the paretic upper limb accounts for a large~     proportion of the disabling sequelae. Only about 15% of those with initial complete upper~     limb paralysis after stroke recover functional use of their impaired arm in daily life.~      The aim of this study is to test the effects of tDCS combined with upper extremity~     robot-assisted therapy on stroke survivors.~   "
93874|NCT01828385|"~     The aim of this study is to determine the recovery time of moderate neuromuscular blockade~     with sugammadex in adults pretreated with magnesium sulfate.~   "
93875|NCT01828372|"~     The study includes two study parts in which blood is collected from the patients.~      Study part A (observational study, already received positive ethics committee vote; Our~     sign: 12-330): Use of blood samples gathered during routine blood withdrawal Study part B~     (interventional study in the sense of additional blood samples but without an~     investigational product): Optional, for further pharmacokinetic questions: blood withdrawal~     with a maximum of 20 ml ( ten tubes of 2 ml each) within a maximal study length of four~     weeks.~      The primary objective of this study is to gain an overview about drug concentrations in~     plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in~     patients. Any drug may be tested, however the initial focus is on antiinfective,~     antineoplastic, and antipsychotic drugs.~      Many published studies show that there is a profound lack of information on pharmacokinetics~     and interactions of many commonly used drugs in clinical routine, and that drug~     concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic~     range (provided that such ranges are known at all).~   "
93876|NCT01828359|"~     The purpose of this study is to evaluate the blood pressure lowering effects of an~     amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination~     treatment in patients with essential hypertension uncontrolled with losartan 100mg~     monotherapy.~   "
93877|NCT01828346|"~     This is a dose escalation followed by dose expansion study of TL32711 in combination with~     5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have~     failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that~     5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.~   "
93878|NCT01828333|"~     The MATIAS study aims to demonstrate through limited scope implementation studies how~     injectable artesunate may be progressively rolled out nationwide in the Democratic Republic~     of the Congo as the preferred treatment for severe malaria.~   "
93879|NCT01828320|"~     There is an urgent need to identify modifiable mechanisms contributing to risk and~     vulnerability among youth. The investigators test the hypothesis that eveningness, the~     tendency to go to sleep late and wake late, is an important contributor to, and even cause~     of, vicious cycles that escalate vulnerability and risk among youth. This study seeks to~     determine whether two interventions to reduce eveningness can reduce risk and confer~     resilience in critical aspects of health, development and functioning in youth.~   "
93880|NCT01828307|"~     Relapse contributes significantly to the chronicity of substance use disorders, one of the~     most costly medical/mental health problems facing our nation. The incorporation of exercise~     into relapse prevention efforts will address stress, a critical factor in relapse, provide~     other health benefits, and improve overall quality of life. Combined, these changes will~     reduce the risk of relapse to substance use while also lessening the burden of this~     psychiatric disorder upon society~   "
93912|NCT01827891|"~     This single-center, randomized controlled trial is to investigate the impact of remote~     ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its~     long-term impact on renal function for patients with diabetes undergoing percutaneous~     coronary intervention.~   "
93881|NCT01828294|"~     The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive~     acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients~     may or may not be receiving anticholinesterase agents. A common treatment for patients with~     this disease includes the administration of intravenous immunoglobulin (IVIG), which is a~     plasma protein that is given to help maintain adequate antibody levels to prevent infections~     and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to~     test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and~     thighs) will be better tolerated for patients with Myasthenia Gravis.~   "
93882|NCT01828281|"~     We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver~     and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric~     and liver fat, plasma lipids, carotid artery thickness.~   "
93883|NCT01828268|"~     The purpose of this plot study is to find out the relationship between metabolic changes and~     anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients~     using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics~     methodology.~   "
93884|NCT01828255|"~     The purpose of this study is to investigate how the intraocular pressure (IOP) varies in~     time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns~     will be recorded continuously over 24 hours with SENSIMED Triggerfish®, a portable~     investigational device using a contact lens sensor. After completing the Triggerfish lens~     placement and removal; the patient will complete a formal Polysomnography.~   "
93885|NCT01828242|"~     Life style changes, particularly in dietary patterns have contributed a great deal to the~     incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced~     by pre processed food, added sugar and those of animal origin lead towards rapid increase of~     adult-onset-diabetes.~      In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are~     well informed, they still need to be committed to perform a behavior and implement these~     intention. Behavioral approach methods have demonstrated successful adherence in health~     education with life style changes.~      Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in~     Type 2 Diabetes Mellitus adults in achieving glycemic control.~   "
93886|NCT01828229|"~     Epidemiological studies as well as both longitudinal animal and human inactivity studies~     indicate that low physical activity is associated with the pathophysiology of type 2~     diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical~     inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical~     inactivity, a high energy dietary intake, and T2DM are also associated with dementia,~     depression, and impaired cognitive function. It is critical that we understand how~     inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if~     normal physical activity can prevent these changes, and if there are any differences between~     sexes.~      The present protocol is divided in several in several sub-studies:~        1. To test whether and how a physically inactive lifestyle will influence body~          composition, glucose and lipid metabolism, and cognitive function.~        2. To test whether normal physical activity can prevent the deleterious effect of a~          physically inactive lifestyle despite a high-caloric intake.~        3. To test whether the influence of a physically inactive lifestyle combined with a~          high-caloric intake differs between sexes.~   "
93887|NCT01828216|"~     Very few studies have examined different models of care involving initial ambulatory~     home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who~     benefit from continuous positive airway pressure (CPAP), and reducing the need for~     polysomnography (PSG). This study aims to assess the role of an ambulatory approach with~     home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the~     conventional approach in managing OSA in terms of improvement of clinical outcome but the~     former approach will lead to substantial cost savings.~   "
93888|NCT01828203|"~     The objective of this study is to assess the efficacy of IV minocycline in improving~     neurological and functional outcome after acute non-penetrating traumatic spinal cord injury~     (SCI).~      The primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose~     tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered~     to subjects with acute traumatic non-penetrating cervical SCI starting within 12 hours of~     injury will improve motor recovery as assessed by the International Standards for Neurologic~     Classification of Spinal Cord Injury - ISNCSCI (a.k.a. ASIA) neurological examination~     measured between 3 months and 1 year post-injury, compared to placebo.~      The secondary hypotheses are that the above minocycline treatment will also results in~     improvement in ASIA sensory improvement, in ASIA grade and in functional outcome as assessed~     by Spinal Cord Independence Measure (SCIM) and Short Form 36 (SF-36), compared to placebo.~     In addition the effect of minocycline on neurological and functional outcome after SCI is~     expected to be more pronounced in those subjects with motor incomplete SCI compared to those~     with motor compete SCI. A subgroup analysis will be undertaken to examine this hypothesis.~   "
93889|NCT01828190|"~     The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     patient suffering from residual Crohn's disease related perianal fistulas already treated~     with TNF alpha blockers~   "
93890|NCT01828177|"~     This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of~     PDI-320, and the individual components, in adult subjects with rosacea.~   "
93891|NCT01828164|"~     To study whether or not the Aevo System™ medical device enhances the rate of tooth movement~     in human subjects who use orthodontic braces.~   "
93892|NCT01828151|"~     To assess risk of skin pressure lesions in patients treated with noninvasive mechanical~     ventilation.~   "
93907|NCT01827956|"~     Hypothesis:~      Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally~     advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive~     biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown~     recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor~     activity of trastuzumab and cetuximab.~      The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms~     may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers~     with recurrence or metastatic disease that make them inaccessible to loco regional~     treatment.~   "
93893|NCT01828138|"~     Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all~     pregnancies. It is a serious condition with acute proteinuria and hypertension and varying~     degrees of edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight~     because of prematurity with inherent complications. The pathogenesis is unknown but is~     assumed to involve placental ischemia.The primary placental disorder results in renal~     glomerular injury. Established PE is associated with paradoxical suppression of the~     renin-angiotensin-aldosterone system, RAAS.~      Despite suppressed RAAS, patients with PE retain NaCl(sodium chloride) after an intravenous~     isotonic NaCl overload compared to healthy pregnant women on a low NaCl diet. The~     investigators believe to have data that provide a possible explanation for the overall~     relationship between proteinuria, NaCl retension, suppression of RAAS, hypertension and~     underdevelopment of placenta. Earlier data, which the investigators have confirmed, shows~     abnormal glomerular loss of the enzyme plasmin/plasminogen from plasma to the urine in PE.~     Active plasmin in urine from patients with nephrotic syndrome and PE activates the~     epithelial sodium channel ( ENaC ) in renal collecting duct cells. The investigators~     hypothesize that loss of plasmin/plasminogen are shared for the diseases with proteinuria,~     including PE, and that plasmin- driven ENaC (epithelial sodium channel) activation is a~     causal factor in the pathophysiology of established PE. Hyperactive ENaC causes primary~     renal sodium retention with secondary suppression of the renin-angiotensin-aldosterone~     system. Aldosterone is recently established as a placental growth factor.~      Plasma-aldosterone levels are significant higher in normal pregnant women. PE is~     characterized by low aldosterone levels (a discovery the investigators have also confirmed)~     and by placental underdevelopment.~      Study Aim: To test specific hypothesis regarding established PE´s pathophysiological~     mechanisms.~      Study Hypothesis:~        1. Excretion of urine proteases (plasmin/plasminogen) in PE leads to an activation of ENaC~          and hence RAAS is less NaCl sensitive while the blood pressure is more NaCl sensitive~          compared to healthy pregnant women.~        2. The degree of aldosterone suppression in PE determines placental development~   "
93894|NCT01828125|"~     In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment~     because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or~     intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually~     associated with undesirable side-effects such as nausea, vomiting, bloating and headache.~      The overall objective of this research proposal is to assess the efficacy of lower~     subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the~     standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).~      It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously~     will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia~     without the undesirable gastro-intestinal side effects.~   "
93895|NCT01828112|"~     The primary purpose of the study is to compare the antitumor activity of LDK378 vs.~     chemotherapy in patients previously treated with chemotherapy (platinum doublet) and~     crizotinib.~   "
93896|NCT01828099|"~     The primary purpose of the study is to compare the antitumor activity of LDK378 versus~     reference chemotherapy.~   "
93897|NCT01828086|"~     A randomized, double-blind, placebo and positive controlled, single and multiple dose study~     to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in~     chronic plaque-type psoriasis patients.~   "
93898|NCT01828073|"~     This study will evaluate the safety and pharmacokinetics (PKs) of exposure (in utero or~     intrapartum) to raltegravir (RAL) in infants born to HIV-infected pregnant women who~     received RAL during pregnancy. (Pharmacokinetics are the various interactions between a drug~     and the body.) This study will also seek to develop an infant RAL dosing regimen to be~     evaluated in a follow-up study.~   "
93899|NCT01828060|"~     The purpose of this study is to evaluate the timing and magnitude of improvements to red~     blood cell health associated with consumption of Jobelyn™.~   "
93900|NCT01828047|"~     The aim of this pilot study is to establish if a correlation between sub-lingual~     microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of~     postoperative ileus exist in patients undergoing elective colorectal surgery.~   "
93901|NCT01828034|"~     The purpose of this study is to test an investigational combination of drugs for bile duct~     or gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly~     used in combination to treat bile duct and gallbladder cancers. The investigators are~     looking to improve treatment results. They will attempt to do so by adding the drug MEK162~     to the treatment plan. MEK162 acts by blocking a protein called MEK 1/2 which helps cancer~     cells grow and divide. This study will help answer the question of whether MEK162 is a~     helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine~     and cisplatin.~   "
93902|NCT01828021|"~     The purpose of this study is to determine if margetuximab is effective in the treatment of~     certain patients with relapsed or refractory advanced breast cancer.~   "
93903|NCT01828008|"~     To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in~     refractory and/or chemoresistant lymphomas.~   "
93904|NCT01827995|"~     It is estimated that around 50 000 women die every year due to consequences of unsafe~     abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where~     access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place~     a huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care~     (CAC) would mean important improvements for the concerned women and their families (Singh,~     2006) as well as for the societies at large. Recommended improvements concern increased~     access to the safest and most cost-effective methods such as medical abortion provided at~     primary level facilities (Singh et al, 2009). A Cochrane Review concludes that most~     randomised controlled trials within the field of medical abortion are conducted in~     high-income settings with good access to emergency health care services (Kulier et al,~     2004). A simplified regime for medical abortion, which could be used at primary level~     facilities, would contribute to the reduction of maternal mortality and morbidity related to~     unsafe abortions globally. However, there is a knowledge gap in order to determine if a~     simplified follow up of medical abortion is equally effective as the standard procedure in a~     low-income setting. The results will provide evidence-based information to be used in~     revising training and service delivery guidelines' in order to reduce maternal mortality and~     morbidity in both low and high-income setting.~   "
93905|NCT01827982|"~     The purpose of this study to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of JNJ-54861911 which is currently being developed for the treatment of~     Alzheimer's Disease.~   "
93906|NCT01827969|"~     The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by~     MRI, performed under local anesthesia and sedation.~   "
93908|NCT01827943|"~     In the absence of standard treatment in this indication, this test evaluates a new drug type~     targeted therapy in this indication, evaluating its efficacy in terms of tumor response and~     survival.~   "
93909|NCT01827930|"~     The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with~     CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response~     and major molecular response rate) is dependent on the residual plasma Imatinib.~   "
93915|NCT01827852|"~     This prospective observational study will evaluate the efficacy and safety of first-line~     Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age~     groups (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or~     recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months~     from the start of first-line therapy.~   "
93916|NCT01827839|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster~     (HZ). The data collected will be compared with the data from subjects without HZ in other~     HZ/su trials.~   "
93917|NCT01827826|"~     It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing~     to this national trend is the obesity epidemic. Three randomized trials have demonstrated~     that intensive behavioral interventions can prevent or delay the onset of diabetes. The~     purpose of this pilot study is to inform a future randomized, controlled Phase III trial of~     a population-based, telephonic, exercise and weight loss intervention to translate the~     findings of the Diabetes Prevention Program into practice. The telephonic intervention will~     be compared to usual care (30 participants in each group). The investigators will deliver~     the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for~     a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and~     24 weeks.~      For this planning grant the investigators do not have an overall hypothesis. The~     investigators' goal is to develop and test whether it is possible to do exercise and weight~     loss~   "
93918|NCT01827813|"~     OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols~     in patients with a negative initial biopsy but continued suspicion for prostate cancer~     MATERIALS AND METHOD Data of the patients who underwent prostate biopsy between June 2007~     and June 2012 were retrospectively assessed. Patients with an abnormal digital examination~     findings and/or abnormal serum prostate specific antigen levels were biopsied. The~     indication for a repeated biopsy was determined as the continued suspicion for a malignancy~     after the initial benign biopsy result and/or a pathology result consistent with a~     high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation.~     Patients who underwent saturation and core 10-12 biopsies at repeated biopsies were~     compared. Statistical analyses were performed with Shapiro-Wilk test and Mann- Whitney U~     test. A p value less than 0.05 was accepted as statistically significant.~   "
93919|NCT01827800|"~     This purpose of this trial is to determine whether a 12-month eHealth behavioral~     intervention that includes interactive self-monitoring and feedback, tailored skills~     training materials, telephone counseling calls, and primary care physician (PCP) counseling~     will produce greater weight change at 12 months than a standard primary care control.~   "
93920|NCT01827787|"~     This research study is a phase II clinical trial. Phase II clinical trials test the~     effectiveness of a drug to learn whether the drug works in treating a specific cancer.~      Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with~     metastatic breast cancer who have received at least two prior chemotherapy regimens. It~     works by interfering with cancer cell division, growth and spread.~      In this research study, the investigators are looking to see how well Eribulin helps~     participants with metastatic breast cancer as a first-line or second-line chemotherapy~     treatment. The investigators also would like to learn about the side-effects that~     participants experience with this medication, in particular, neuropathy.~      Neuropathy is a condition in which the nerves are affected, leading to numbness or tingling~     of the fingers and toes. The investigators would like to study the effect Eribulin has on~     the nerves through regular questionnaires that ask about any nerve-related symptoms. The~     investigators also plan to send blood samples to determine if gene markers may indicate~     increased sensitivity to the nerve effects of Eribulin.~   "
93921|NCT01827774|"~     The purpose of this Study is to collect information about the performance of the Surgisis®~     Soft Tissue Graft (Study Product) for the repair of pelvic organ prolapse in women.~   "
93922|NCT01827761|"~     This study will evaluate whether chemotherapy teaching sessions improves patient's~     knowledge, preparedness and anxiety in relation to chemotherapy. This study will also~     evaluate the effect of age, race, native language, education level, type of cancer and~     chemotherapy regimen on the oncology teaching session.~   "
93923|NCT01827748|"~     The purpose of this study is to evaluate the accuracy and repeatability of an individually~     validated prototype autorefractor designed to be mounted on a surgical microscope.~   "
93924|NCT01827735|"~     Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused~     by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing~     pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia.~     Currently, medical management of type 1 diabetes focuses on intensive insulin replacement~     therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical~     outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies~     that can arrest the autoimmune process and thereby preserve residual insulin production~     leading to fewer complications and better clinical outcomes.~      The vast majority of genes that contribute to susceptibility to type 1 diabetes have been~     found to encode proteins involved in immune regulation and function. In particular, several~     susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T~     cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2~     product produced by recombinant DNA technology using genetically engineered E. coli stain~     containing an analog of the human interleukin-2 gene. There is substantial nonclinical,~     preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the~     autoimmune mediated destruction of pancreatic beta cells by induction of functional T~     regulatory cells. However, prior to embarking on large proof of concept trials in type 1~     diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The~     objective of this study is to establish in patients with type 1 diabetes the optimal dose of~     IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.~   "
93992|NCT01826838|"~     Radiation and androgen deprivation is a common modality for patients with localized prostate~     cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete~     tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway~     appears to be integral to the pathobiology of prostate cancer and may be fundamental to~     radioresistance.~   "
93925|NCT01827722|"~     CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous~     condition because the vessels are weak and prone to leakage. This results in the development~     of macular edema.~      Previous studies have shown that inflammatory mediators and growth factors, such as vascular~     endothelial growth factor (VEGF), are elevated in patients with macular edema associated~     with CRVO.~      Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by~     prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It~     is also indicated for the treatment of non-infectious uveitis affecting the posterior~     segment of the eye. The approved dosage is 0.7 mg.~      Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is~     available by prescription for other eye disorders, such as wet age-related macular~     degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME).~     The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given~     monthly. The approved dosage for DME is 0.3 mg given monthly.~      Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of~     treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg~     Lucentis®, given as separate injections into the eye.~   "
93926|NCT01827709|"~     Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional~     advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an~     important issue, if the investigators want to improve the therapeutic index in HNC. This~     could be achieved by a more accurate definition of the tumor volume and by identification of~     radioresistant volumes within the tumor. Recent literature puts in this regard the~     incorporation of functional imaging (FI) in the RT treatment planning forward as a promising~     tool.~      FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is~     in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning,~     sufficient margins need to be placed around the tumor volume in order to compensate for~     geometric uncertainties. Consequently many surrounding functional structures receive high~     doses of irradiation, resulting in side effects. It is expected that, using FI in RT~     treatment planning will make these margins smaller or even unnecessary, which will result in~     less irradiation of the surrounding tissues. So far only one study has reported a comparison~     between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological~     tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT~     correlated more to tumor volumes defined by pathology and were significantly smaller.~      Furthermore, FI provides us with a deeper insight in the tumor's underlying biological~     activity and microstructure. These techniques can thus help to identify radioresistant~     subvolumes which might benefit from treatment intensification.~      A validation of these FI modalities with pathology is necessary to investigate their true~     power in tumor delineation and in the identification of radioresistant subvolumes.~   "
93927|NCT01827696|"~     Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to~     engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness.~     Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of~     perceived soreness before and several times after the exercise.~   "
93928|NCT01827683|"~     The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     patients suffering from chronic pain syndrome (Fibromyalgia).~   "
93929|NCT01827670|"~     Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice~     daily brushing of a toothpaste containing stannous fluoride in comparison to marketed~     (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous~     fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed~     (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.~   "
93930|NCT01827657|"~     This is a single-dose, open-label, two part, parallel group study. This study is being~     conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in~     subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll~     subjects with mild and moderate hepatic impairment and healthy control subjects matched to~     the subjects in the moderate hepatic impairment category. The decision to commence Part 2~     will be based on a review of the preliminary safety and pharmacokinetic data from subjects~     with moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic~     impairment. Additionally, based on emergent data from Part 1, matched controls to the severe~     hepatic group may be enrolled (optional). Due to the potential difficulty in identifying~     eligible subjects with severe hepatic impairment, the study may be stopped prior to full~     enrollment in Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic~     impairment have been enrolled. The study will consist of a Screening visit, a single dose~     Treatment Period and a Follow-up visit. Subjects will be screened for eligibility criteria~     within 30 days of enrolment. Subjects will be admitted to the clinical unit on Day -1; each~     subject will receive a single dose of GSK2336805 on Day 1 and will remain in the clinical~     unit for 5 days (check-out on Day 4). The follow-up visit will be conducted within 7-10 days~     after Day 1 dosing.~   "
93931|NCT01827644|"~     This will be a randomized, open-label, sequential, single dose, 4-period crossover study.~     This study is being conducted to measure the relative bioavailability of the original~     gelatin capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose~     [HPMC] capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted~     state. The study will be composed of Screening, Treatment, and Follow-up Periods. Screening~     assessments to determine subject eligibility will be performed within 3 weeks prior to the~     first dose of study drug in the Treatment Period. Eligible subjects will be randomized to~     receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B:~     AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D:~     AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F:~     AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period).~     Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on~     Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB,~     ABFC, BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses~     administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days~     after the last dose. A subject's total time involved in the study will be approximately 9~     weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6~     subjects will be randomized to receive each treatment sequence.~   "
93932|NCT01827631|"~     This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in~     healthy male and female subjects. This study will confirm the PK and safety profile in~     Chinese subjects. GSK1605786 is currently in clinical development for the treatment of~     Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or~     500mg twice daily) within 30 minutes after a meal. The study will consist of single and~     repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.~   "
93933|NCT01827618|"~     This study aims to evaluate the effects of rapamycin directly on bladder tumors and the~     effects of rapamycin on the immune system of patients with bladder cancer.~   "
93934|NCT01827605|"~     This is a Phase III, multicenter, open-label, randomized and controlled study to compare the~     efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR~     after second or third line chemotherapy supplemented with rituximab.~   "
93935|NCT01827592|"~     Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation~     treated for 26 Weeks.~   "
93936|NCT01827579|"~     The purpose of this study is to evaluate whether the administration of allodepleted donor T~     cells to patients with haematological malignancies after stem cell transplant can improve~     the recovery of the patients immune system.~   "
93937|NCT01827566|"~     The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a~     double-blind placebo-controlled challenge with gluten, followed by two months period of~     Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet,~     in patients spontaneously adherent to gluten free diet because of symptoms upon gluten~     exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.~   "
93938|NCT01827553|"~     This randomized trial examines the effectiveness of chemoradiotherapy compared to~     chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of~     FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic~     cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles,~     the agent and its administration for sole chemotherapy is determined by induction~     chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients~     will be followed for the duration of therapy and for 5 years after the last study treatment.~     Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints~     are tumor-free survival, rate of local recurrence or local progression, rate of distant~     metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of~     remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is~     planned to include a total number of 830 patients.~   "
93939|NCT01827540|"~     To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and~     without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy~     subjects.~   "
93940|NCT01827527|"~     The purpose of this study is to develop and refine techniques for using magnetic resonance~     and optical spectroscopy to investigate how your body uses energy.~   "
93941|NCT01827514|"~     Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and~     is responsible for growth and differentiation of the erythroid cell lineage. Our team, in~     collaboration with partners (see below) has taken responsibility to study the presence,~     function and clinical significance of EPO-R in human cancer specimens.~      General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared~     slides from already taken preparations (specimens from Bone Marrow tests) will serve as the~     basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer,~     Lung cancer, Head & Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The~     slides will be stained with anti-EPO-R antibodies (Abs).~   "
93942|NCT01827501|"~     This study is designed to compare the incidence of postoperative delirium in older patients~     after major non-cardiac surgery with different perioperative hemodynamic managements: a goal~     directed hemodynamic management group and a control group~   "
93943|NCT01827475|"~     The purpose of this study is to determine whether the combination of ibuprofen and~     acetaminophen, is more effective than either single agent alone in treating pain from acute~     musculoskeletal injuries in the emergency department.~   "
93944|NCT01827462|"~     The immune system is central to human health and its impairment can have serious~     consequences.~      One of the hallmarks of aging is the progressive loss of immune function exposing older~     people to increased risk from infectious diseases that would not normally be more than an~     inconvenience. This project will use state-of-the-art technology developed by the Stanford~     Human Immune Monitoring Center to survey older individuals for signs of immune system aging~     and to gather information about the factors associated with the decline of immune function.~   "
93945|NCT01827449|"~     The study will compare the rewarming effectiveness of heat donation through the distal arms~     and legs during rewarming of mildly hypothermic subjects. Warming will be accomplished~     through either warm water immersion; and fluidotherapy. The investigators hypothesize that~     fluidotherapy will be as, or more, effective compared to warm water immersion~   "
93946|NCT01827436|"~     The purposes of this pilot research study are 1. To begin to test if two different types of~     physical therapy might have different results in children and adolescents who have had a~     prior stroke, and 2. To determine if either type of physical therapy causes changes in the~     brain signals that control leg muscles. All participants will receive physical therapy 3~     times per week for 8 weeks. Half of the participants will receive typical physical therapy,~     such as walking practice, muscle strengthening, and balance training. Half of the~     participants will receive asymmetrical gait training physical therapy, which uses new~     technology to train each leg differently during walking practice. After enrolling,~     participants will be randomly assigned to the type of therapy. Measurements will be taken~     before, during, and after the 8 weeks of physical therapy. These include walking tests to~     measure symmetry, walking speed and daily step activity, and brain tests to measure the~     strength of the signals from the brain to the leg muscles. One blood test is also taken to~     identify if certain genetic factors affect how each child responds to the physical therapy.~   "
94057|NCT01825967|"~     The management of acute diverticulitis maybe better if we have prognostic markers of~     evolution.~      Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute~     diverticulitis.~      The investigators need to know the values of C-reactive protein to predict evolution of~     acute diverticulitis.~   "
93947|NCT01827423|"~     This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen~     (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of~     SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was~     evaluated as well.~      Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels~     before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and~     postoperative levels of SCCA were compared.~   "
93948|NCT01827410|"~     Is there agreement between data in the Danish Ventral Hernia Database and patient files~   "
93949|NCT01827397|"~     The purpose of the clinical trial is to evaluate the safety and immunogenicity in female~     volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The~     objective of the immunisation is to induce mucosal and systemic binding and neutralizing~     antibodies against HIV in order to block the virus on the mucosal surface and neutralise the~     viral particles that may eventually succeed in crossing the mucosal barrier.~      This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in~     humans.~      Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV,~     but its ability to induce meaningful protection against HIV will not be known before Phase 3~     efficacy trials are completed, as correlates of protection against HIV are not yet clearly~     defined.~      Consequently, there is no direct benefit to volunteers. They will be reimbursed for their~     time and travel.~   "
93950|NCT01827384|"~     This randomized pilot phase II trial studies molecular profiling-based targeted therapy in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment. WEE1 inhibitor MK-1775, everolimus, and~     trametinib are drugs that each target a specific variation in tumors by blocking different~     proteins needed for cell growth. Veliparib blocks an enzyme that helps repair~     deoxyribonucleic acid (DNA) damaged by chemotherapy, which may help chemotherapy drugs work~     better. It is not yet known whether testing patients for variations in their tumor and~     assigning treatment targeting the variation is more effective than standard non-targeted~     therapy in treating advanced solid tumors.~   "
93951|NCT01827371|"~     Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in~     over 2,000 individuals and is on path for licensure. This study will be a Phase II to~     evaluate three different immunization schedules and two different modes of delivery. The~     study will look at condensed schedules. Study will randomize subjects to one of four arms.~   "
93952|NCT01827358|"~     The objective of this trial is 1) to evaluate the safety and clinical acceptability of a~     5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and~     perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in~     eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures~     of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to~     examine the efficacy of mupirocin in achieving persistent eradication of SA colonization~     among infants residing in the ICU,defined as the absence of SA in cultures of the nares,~     umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to~     receive medical care as they otherwise would if they were not enrolled in the trial. The~     study will be powered with a primary endpoint with 126 participants. Enrollment may continue~     to 500 participants to power secondary and exploratory endpoints and assist design~     subsequent studies.~   "
93953|NCT01827345|"~     The role of vitamin D deficiency on increased risk for falls and physical dysfunction is~     unclear. It is also unclear if taking vitamin D improves physical function and reduces fall~     risk in older adults. The purpose of this research study is to explore the effects of taking~     the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical~     functional outcomes in older adults with low vitamin D levels. The investigators hypothesize~     that the participants will experience fewer falls and function better physically after~     taking vitamin D for six months.~   "
93954|NCT01827332|"~     The purpose of this study is to examine the impact of a medication called oxytocin on~     marijuana use and therapy response in people who frequently use marijuana.~   "
93955|NCT01827319|"~     The objectives of the registry are as follows:~        -  Track real world performance outcomes and physician experience using the~          Cardiogenesis Laser System;~        -  Further define the disease characteristics of the population being treated;~        -  Examine transmyocardial revascularization (TMR) usage characteristics and 30-day~          outcomes;~        -  Further assess the 30-day postoperative risk factors for adverse events. To limit the~          potential for bias, all patients eligible for TMR treatment who meet the Inclusion and~          Exclusion Criteria are to be offered the opportunity to enroll in the study at~          participating centers.~   "
93956|NCT01827306|"~     Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for~     home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises~     are considered an important component of care for shoulder pain patients, although pain can~     be a limiting factor in the advancement of rehabilitation. The purpose of this study is to~     evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to~     determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical~     shoulder pain who are candidates for standard shoulder therapy will be randomized into two~     groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while~     the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just~     prior to initiating the in-office exercise program. Values of pain (NPRS) and disability~     (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by~     repeated measures ANOVAs within and between group, time, and interaction main effects.~     Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the~     associated disability. The ability to decrease shoulder pain and disability with a topical~     analgesic will allow health care professionals to advance patients through a therapeutic~     exercise program without the restriction of pain. In turn, patients will correct the~     underlying condition of their shoulder pain at a faster rate.~   "
93957|NCT01827293|"~     This study was a prospective, randomized, double-blind, parallel group clinical trial~     designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the~     treatment of peripheral vertigo in Emergency Department setting.~   "
95895|NCT01801943|"~     The purpose of this study is to determine the effects of a coordinated intervention of~     cognitive remediation training (CRT) and walking intervention on cognition and gait in the~     elderly.~   "
93958|NCT01827280|"~     The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in~     the past decades, and consequently, a higher incidence of cardiovascular diseases is~     observed. As this process develops, the endothelial dysfunction is present at early stages~     of the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of~     endothelial and microvascular dysfunction in obese carriers, even in the absence of~     dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and~     drugs which act not only on diabetes mellitus pathophysiology but also acting as direct~     cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4~     inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin~     mimetic and insulinotropic effects are already well established and several other studies~     show its effectiveness in reducing glycated hemoglobin, even in monotherapy.~      Currently, fat rich foods are being increasingly introduced in the western way of life and~     recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular~     risk. A better glucose control using vildagliptin can reduce the oxidative stress, and~     consequently promote a better microvascular and endothelial reactivity. However,~     vildagliptin can have an additional cardiovascular protective action, not only because of~     its effect on glycemia and oxidative stress reduction, but maybe because of its direct~     effect on intestinal peptides with postprandial lipemia reduction. To test this hypothesis,~     we will proceed the following exams: venous occlusion pletysmography, nailfold~     videocapilaroscopy and laser-Doppler flowmetry aiming to evaluate vascular reactivity on~     muscle and at cutaneous site. Anoter group of patients with the same clinical~     charactherisitics will use metformin, in order to compare its effects with those obtained~     from the use of Vildaglitpin. Our purpose is to determine whether vildagliptin, evaluated in~     obese and diabetic women, has vascular protective effects, and whether the regulatory~     mechanisms of these actions correlate with oxidative stress, inflammatory markers and~     intestinal peptides in baseline state and after a lipid overload.~   "
93959|NCT01827267|"~     This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter,~     multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus~     combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented~     somatic HER2 mutations.~   "
93960|NCT01827254|"~     Retrospective and prospective study in mRCC patients treated with sutent in first line and~     rechallenged by Sutent in 3rd and 4th line.~   "
93961|NCT01827241|"~     With this study, we plan to review the performance of colonoscopy in colon cancer screening~     and surveillance, especially with the recent improvements in endoscopic technology (high~     definition endoscopes), use of split dose preparation which provides excellent colon~     preparation for detection of lesions and increasing awareness and detection of flat lesions~     of the colon. The findings will help us define the role of colonoscopy screening of colon~     polyps and flat lesions and identity areas for improvement. The data will be used for~     continuing quality improvement and presenting our outcomes at academic meetings and~     publishing our results in peer reviewed journals.~   "
93962|NCT01827228|"~     Half or more of HIV transmission events may occur within the period of high infectivity (and~     often high risk behavior) that can last 11 months or more after a person is initially~     infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection~     projects have found effective ways to intervene against transmission during this risky~     recent infection period. The investigators seek to develop effective intervention~     techniques against HIV transmission during the recent infection period using a combination~     of injection-, sexual- and social-network-based contact tracing methods; community alerts in~     the networks and venues of recent infectees; and the logic of going up and down~     infection chains.~      The investigators first Aim is to develop and evaluate ways to locate seeds, defined as~     drug users and other people who have recently been infected. The investigators second Aim~     targets members of seeds' networks and people who attend their venues. The investigators~     will test them for acute and for recent infection, and alert them to the probability that~     their networks contain highly-infectious members so they should reduce their risk and~     transmission behaviors for the next several months to minimize their chances of getting~     infected. This may also reduce transmission by untested people with recent infection.~     Community, network and venue education about the need and value of supporting those with~     recent infection should reduce stigma. The investigators third Aim is to reduce HIV~     transmission and to develop new ways to evaluate prevention for positives generally as~     well as The investigators own success in reducing transmission.~      The investigators will do this using a combination of follow-up interviews and testing,~     including of viral loads; phylogenetic techniques; and discrete event simulation modeling to~     assess The investigators effectiveness.~   "
93963|NCT01827215|"~     This study is to examine the effectiveness of a health communication system (Gabby) that~     assesses preconception health risks and tailors the education and intervention to each~     subject, based on her health risks. This project specifically targets young Black or African~     American women in order to reduce major disparities in birth outcomes. Clinicians do not~     have time to assess for the over 100 preconception health risks that can impact birth~     outcomes; the investigators system can streamline that assessment and create a personalized~     list of risks. Patients can then share their list with clinicians to make their healthcare~     visits more effective.~      The investigators will conduct a two-armed randomized controlled trial (RCT) designed to~     enroll 530 African American women ages 18-25. After all subjects complete a comprehensive~     preconception health risk assessment, the intervention group will be trained to use the~     Gabby system and encouraged to use it at least monthly for one year. The control group will~     receive a letter listing the risks identified and they will be encouraged to see their~     clinician to discuss them.~      The investigators primary hypothesis will test whether the Gabby system will result in a~     lower rate of preconception health risks, as defined by CDC, as compared to the control~     group after 12 months. Secondary outcomes include: measurement of usage rates, dose of~     exposure, attrition, subject and healthcare provider satisfaction, and number of women with~     a personalized health plan.~   "
93964|NCT01827202|"~     Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI)~     has long been propagated to effectuate beneficial outcomes. However, recent large clinical~     trials have outlined harmful effects for DRI in combination with other forms of RAS~     blockade. To date, information regarding DRI as RAS-blocking monotherapy is very limited.~     Furthermore, it remains to be elucidated how DRI and angiotensin receptor blockers affect~     the so-called 'classical' and 'alternative' RAS molecularly. As components of the~     'alternative' RAS (e.g. Ang 1-7) have moved into research focus, it would be of importance~     to determine angiotensin regulation with medical RAS blockade.~      In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic~     kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either~     aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week~     run-in phase where all RAS-blockers are eliminated. The investigators will then employ a~     novel mass spectrometry-based quantification method (after run-in and 10 weeks) to capture~     the concentrations of ten different angiotensin peptides (including angiotensin I and II,~     angiotensin 1-7 and angiotensin 1-5).~      The investigators hypothesize that significant differences exist between angiotensin levels~     in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the~     investigators expect to determine the regulation of the alternative RAS represented by~     angiotensin 1-7 with proximal versus distal blockade of the system.~      Our data might contribute to a more profound understanding of results from registries and~     clinical trials beyond the clinical effects of RAS blockade. Further, the study's results~     might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.~   "
93965|NCT01827189|"~     Examines staff size and composition of the 496 advanced primary care practices participating~     in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that~     were selected for the demonstration.~   "
93966|NCT01827176|"~     The purpose of this study is to determine the clinical characteristic of recurrent acute~     rhinosinusitis in children.~   "
93967|NCT01827163|"~     The purpose of this study is to study a new treatment for HER2-positive breast cancer.~   "
93968|NCT01827150|"~     The present proposal investigates the influence of energy drinks on the blood oxygenation~     concentration of the optic nerve on healthy subjects. On a voluntary basis, 15 subjects, man~     or woman, will be selected to undergo this experiment. Many factors can influence the blood~     oxygenation concentration of the optic nerve, which will be measured also during this~     experiment, namely: Intra ocular pressure (IOP), blood pressure, heart rate and systemic~     hemoglobin saturation.~      The subjects will have to be tested twice to test the two conditions of this experiment:~        1. The effect after the intake of a can of Redbull (250 ml)~        2. The difference with the intake of 250 ml of water~      The purpose of this study is to determine if the blood oxygenation concentration of the~     optic nerve varies after having ingested 250 ml of Redbull.~      Our hypothesis are:~        1. The blood oxygenation concentration of the optic nerve measured with OSOME (see~          detailed description below), decreases due to the consumption of the energy drink~          Redbull compared to an equal volume of water.~        2. The IOP measured with iCare tonometer decreases after the consumption of the energy~          drink Redbull compared to an equal volume of water.~        3. The systemic blood pressure, measured with an automatic sphygmomanometer remains~          constant after ingestion of Redbull energy drink or an equal volume of water.~        4. Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull~          energy drink compared to an equal volume of water.~        5. The rate of systemic hemoglobin saturation measured with a pulse oximeter remains~          constant after the ingestion of a Redbull energy drink or an equal volume of water.~   "
93969|NCT01827137|"~     The purpose of this study is to see if the investigator can help the immune system to work~     against myeloma. Because cancer is produced by the patients own body, the immune system does~     not easily recognize and fight cancer cells. The immune system needs to be trained to do~     this.~      This disease has been selected for this study because the Wilms Tumor 1 (WT1) protein is~     often present in myeloma cells. WT1 is a gene that is involved in the normal development of~     kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved~     in the development of cancer. This study will determine whether the WT1 vaccine causes an~     immune response which is safe and able to keep the myeloma from coming back.~   "
93970|NCT01827124|"~     Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of~     placental delivery in 2nd trimester interruption.~   "
93971|NCT01827111|"~     The goal of this clinical research study is to learn if the combination of ipilimumab and~     ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug~     combination will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Abraxane is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~   "
93972|NCT01827098|"~     Both methods tested in this study disinfect the non-vital root canals and induce blood clot~     formation inside the root canal. One method places calcium hydroxide inside the root canal~     after disinfection and the blood clot is induced four weeks later.~      The other method performs disinfection and induction of blood clot in one appointment. The~     investigators hypothesize that both methods will obtain the same success rate in eliminating~     infection, increase in root length and canal walls thickness.~   "
93973|NCT01827085|"~     The purpose of the study is to investigate wether the use of the Stortz video laryngoscope~     will render in shorter time for the intubation of obese patients compared with the use of a~     conventional Macintosh laryngoscope.~   "
93974|NCT01827072|"~     Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European~     Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet~     all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01~     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients~     receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and~     the Guy's Neurological Disability Scale（GNDS） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
93975|NCT01827059|"~     SUMMARY Rationale: Pulmonary arterial hypertension (PAH) can be a rapidly progressive~     disorder and is associated with a high mortality rate, despite medical intervention. With~     the availability of effective therapy, early disease detection is an important strategic~     objective to improve treatment outcomes. Resting echocardiography is currently the~     recommended screening modality for high-risk population groups. However, it is clear that~     abnormalities in resting hemodynamics (and symptoms) are late sequelae of the~     pathobiological processes that begin in the distal pulmonary arteries. Exercise stress may~     unmask early pulmonary vascular dysfunction, however the definition, clinical significance,~     and natural history of 'exercise PAH' remain undefined. However, based on clinical~     experience and literature the prevalence is estimated at ~ 20%.Treatment with endothelin~     receptor blockers has shown a beneficial influence on the clinical performance in patients~     with exercise induced PAH due to systemic sclerosis and primary pulmonary hypertension.~     Whether endothelin receptor blockers decrease pulmonary pressures and improve clinical~     outcome in patients with exercise induced pulmonary arterial hypertension due to congenital~     heart disease is unknown.~      Objective: Identify congenital heart disease patients with exercise-induced pulmonary~     arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in~     patients with exercise induced pulmonary arterial hypertension before and after treatment~     with bosentan, compared to placebo.~      Study design: Randomized placebo controlled trial with a study period of 26 weeks.~      Study population: Adult congenital heart disease patients with exercise induced pulmonary~     arterial hypertension (n=40) from the Academic Medical Centre, Amsterdam.~      Intervention: After randomization one group (n=20) receives a 125 mg tablet of Bosentan~     twice daily for 6 months. The other group (n=20) receives placebo for 6 months.~      Main study parameters/endpoints: To determine wether bosentan (endothelin receptor~     inhibitor) decreases mean pulmonary arterial pressure at peak exercise in adult congenital~     heart disease patients with exercise induced pulmonary arterial hypertension. Furthermore~     the change in cardiopulmonary exercise capacity and right ventricular function will be~     investigated.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All investigations, blood analysis excepted, are non-invasive and free of risk.~     The burden for the patients mainly consists of the time that is consumed by the~     investigations, namely: history taking + physical examination (15 min); Quality-of-Life-~     score (15 min); laboratory tests (electrolytes, creatinine, urea, albumin and neurohormones,~     troponin T); 12 lead electrocardiogram (10 min); exercise echocardiography (30 min);~     cardiovascular exercise testing (30 min).~      The trial medication has a potential risk of liver damage, which will be monitored regularly~     by laboratory testing of liver transaminases.~   "
93976|NCT01827046|"~     A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of~     minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).~   "
93977|NCT01827033|"~     This research is being done to learn about the effects of doing meditation (sitting quietly~     and concentrating) on people's ability to pay attention and be relaxed.~   "
93978|NCT01827020|"~     The purpose of this study is to determine whether subanesthetic ketamine addition to~     lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.~   "
95896|NCT01801930|"~     To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed~     Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy~   "
93979|NCT01827007|"~     The aim of the study is to evaluate whether fluid responsiveness of the critically ill~     patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood~     pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left~     ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test).~     The chances are compared to increase of CI after volume expansion (gold standard). In~     clinical practise, it would be especially relevant if PEEP-induced changes in arterial~     pressure variations could be used in evaluation of volume status and fluid responsiveness.~     However, as ECHO-derived variables are used in greater extent to guide the treatment with~     inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic~     measurements is essential in the study design.~   "
93980|NCT01826994|"~     Rationale:~      Thoracic complaints, possibly due to a cardiac ischemic cause are a diagnostic challenge in~     general practice. When an underlying ischemic cardiac condition (AMI (acute myocardial~     infarction), UAP (unstable angina pectoris)) is considered, referral from general~     practitioner (GP) to a cardiologist has to take place. However, cardiac analysis in 80% of~     referred patients is negative. To optimize referral decisions of GPs, new and fast~     diagnostics are needed.~      Objective:~      To assess the incremental diagnostic value for AMI of a novel rapid PoC H-FABP-test in~     addition to history taking and physical examination in patients presenting in daily general~     practice with possible AMI. In addition the cost-effectiveness of the test will be~     evaluated.~      Study design:~      Delayed type cross-sectional diagnostic study.~      Study population:~      Patients presenting to the GP with any new-onset chest complaint, at time of presentation~     not lasting for more than 24 hours, that is considered to be of possible cardiac origin by~     the GP.~      Intervention:~      Point of care Heart Type Fatty Acid Binding Protein test (PoC H-FABP-test), added to usual~     care. PoC H-FABP-testing, by qualitatively measuring H-FABP in one single drop of blood~     obtained by finger prick, is added to normal procedures of consultation and referral~     decision by the GP.~      Main study parameters / endpoints:~      Sensitivity, specificity, positive and negative predictive value of point of care~     H-FABP-testing for AMI, alone as well as part of a clinical diagnostic algorithm, in~     patients with thoracic complaints in general practice. All outcome measures, based on using~     an algorithm and/or point of care H-FABP-testing, will be compared to regular diagnostic~     assessment by the GP without using an algorithm and/or point of care H-FABP-testing.~     Therefore, incremental value of H-FABP-testing and/or a diagnostic algorithm is measured.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Individual participants will experience low risk, since study participation comprehends~     regular care except for an extra finger prick and possibly collection of one extra venous~     blood sample. For this low amount of disadvantage, the participant will experience no~     advantage either. However, results of the study will possibly be useful for similar patients~     in future.~   "
93981|NCT01826981|"~     The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of~     combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic~     hepatitis C virus (HCV) infection.~   "
93982|NCT01826968|"~     The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean~     section and in women under general anesthesia improves lung compliance and gas exchange. The~     investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8~     cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment~     maneuver. The primary end point of the study is the improvement of the lung compliance~     measured as volume difference/pressure difference (dv/dp) or ml/cmH2O~   "
93983|NCT01826955|"~     The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position~     could alter the rSO2 and early postoperative cognitive function.~   "
93984|NCT01826942|"~     In this study the investigators intend to determine the impact of fractional CO2 laser~     treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g.~     face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar~     formation. The investigators will also evaluate the effect of shallow fractional laser~     treatment versus deep parameters settings. If effective treatments could be performed at~     time of surgery, this would result in both time and cost saving to the patient and to the~     healthcare system and will improve patient's self-image post surgeries.~   "
93985|NCT01826929|"~     The purpose of this study is to determine whether a multifactorial primary care intervention~     based on chronic models can improve the level of control and reduce the number of hospital~     admissions in patients with ischemic heart disease.~   "
93986|NCT01826916|"~     EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and~     efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients~     with Hereditary Angioedema.~   "
93987|NCT01826903|"~     The purpose of this study is to examine whether the successful perinatal depression~     intervention among mothers (Thinking Healthy Programme, THP) has led to improved~     developmental outcomes in the children 6 years later. Economic and human resources aspects~     of the intervention will also be evaluated to determine overall societal benefits from~     investment in such a program, feasibility of scaling up the intervention and its~     sustainability in the long-term. The primary hypothesis is that children of mothers who~     participated in the THP will have better cognitive outcomes and socio-emotional functioning~     when compared to children of mothers randomized to the control group.~   "
93988|NCT01826890|"~     Many patients admitted to intensive care have heart or lung problems. Patients with these~     conditions often require longer durations of support from breathing machines. Survival and~     long-term recovery are improved if the investigators can remove the breathing support~     quickly. In this study, the investigators will focus on patients with severe lung or heart~     disease to examine whether a particular type of breathing machine (NAVA ventilator) will~     allow us to remove breathing support more quickly and with less need for sedative~     medications, when compared to current practice.~   "
93989|NCT01826877|"~     This phase I trial studies the side effects and best dose of autologous dendritic cells in~     treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells~     and white blood cells may help the body build an effective immune response to kill tumor~     cells.~   "
93990|NCT01826864|"~     This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to~     see how well it works compared to hypertonic saline before sentinel lymph node biopsy in~     treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate~     the immune system in different ways and stop cancer cells from growing. It is not yet known~     whether sargramostim is more effective than hypertonic saline in treating patients with~     stage IB-II melanoma undergoing sentinel lymph node biopsy.~   "
93991|NCT01826851|"~     Exparel is a new local analgesic (numbing medication) that is intended to be longer acting~     than currently available local analgesics. The purpose of this study is to determine whether~     use of Exparel to numb the nerves along the breastbone after open heart surgery, will~     decrease pain and pain medication use after surgery.~   "
97157|NCT01785316|"~     A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic~     Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in~     patients with isolated liver metastases from uveal melanoma.~   "
93993|NCT01826825|"~     The objectives of this pilot study are:~        1. to determine whether a short cognitive test battery administered in the preadmission~          test center can be used to cognitively stratify elderly patients presenting for~          elective surgical procedures.~        2. to evaluate the cost of cognitive screening in the preoperative testing center in terms~          of time and finances.~        3. to evaluate patient perceptions about the use of preoperative cognitive screening and~          their outcome expectations from their surgical procedure.~      Subsequent investigations may evaluate whether preoperative cognitive screening is a~     predictor of postoperative morbidity and mortality in elderly surgical patients and whether~     a short cognitive screen administered in the preadmission testing center could be used to~     identify individuals with baseline cognitive impairments that should be refered for more~     formal cognitive evaluation.~   "
93994|NCT01826812|"~     To assess the reading function impairment in patients with dry eye and to assess the effects~     of reading on the ocular surface.~   "
93995|NCT01826799|"~     Rationale: Sound levels in the Intensive Care Unit are frequently reported to exceed the~     recommended levels. It is plausible to assume that this causes sleep disturbance in the~     patients on the ICU.~      Goals/endpoints: to assess sound pressure levels in 6 different Dutch ICU´s and evaluate the~     effect of higher levels on sleep as perceived by the patient.~      Study design: observational multicenter study~      Study population: adult ICU patients > 18 years old with an expected duration of stay of~     more than 24 hours~      Study parameters/endpoints:~      Primary~        1. To gather information on how Dutch ICUs perform on sound levels~             1. Average sound pressure level~             2. Number of sound peaks~        2. To question patients about their perception of sleep quality (measured by RCSQ)~        3. Causes of elevated sound pressure levels~        4. Identification of the most annoying sounds experienced by the patient~      Secondary~      1) Incidence of delirium measured by CAM-ICU~   "
93996|NCT01826786|"~     The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating~     anxiety disorders through evaluation of brain activation patterns using imaging technology~     in healthy volunteers.~   "
93997|NCT01826773|"~     The study is designed to evaluate how safe and how well an investigational imaging product~     CardioPET™ performs as compared to standard approved imaging products in assessing the~     function of heart muscle in coronary artery disease patients.~   "
93998|NCT01826760|"~     This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver~     failure (ACHBLF) on an individual patient level using artificial neural network (ANN)~     system. The area under the curve of receiver operating characteristic (AUROC) were~     calculated for ANN and MELD-based scoring systems to evaluate the performances of the ANN~     prediction.~   "
93999|NCT01826747|"~     The objective is to test the hypothesis that luteal phase support with vaginal progesterone~     leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary~     outcome) when compared to no luteal phase support in a program of intrauterine insemination~     (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of~     the luteal phase will be recorded (secondary outcome) in order to detect luteal phase~     defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase~     prolongation in case of luteal phase support which may be a burden for the patients waiting~     for the outcome of the treatment.~   "
94000|NCT01826734|"~     Background Because dacryoliths occur at low frequency, few studies have focused on their~     composition.~      The investigators aimed to present findings from morphological, chemical, and mineralogic~     analysis of 86 dacryoliths.~      Methods The team studied 86 dacryoliths obtained during 832 dacryocystorhinostomies (DCR)~     performed for postsaccal obstruction. The samples were analyzed with atomic infrared~     spectrometry (80 samples), amino acid analysis (17 samples), scanning electron microscopy,~     and an electron microprobe with an energy dispersive detector (7 samples).~   "
94001|NCT01826721|"~     Solid organ transplant recipients (SOTR) must follow complex medication regimens and require~     a substantial amount of education for effective self-management. The current standard of~     care for post-transplant medication teaching is a Self Medication education program~     conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool~     (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital.~     The ability to control the content, sequence, pace and timing of education in order to~     achieve personal learning objectives, as well as the opportunity for ongoing review and~     reinforcement of information, may be an attractive, convenient and effective teaching~     modality.~      SOTR will be randomly assigned to receive the standard of care or the standard of care plus~     the TMITT intervention. Primary objectives are to compare patient satisfaction and~     medication knowledge between the two groups at baseline and 3 months using modified versions~     of previously published questionnaires. Medication adherence as measured by a~     multidimensional approach including both subjective and objective components, will also be~     compared at 3 months. Our hypothesis is that an education strategy that includes both the~     standard pharmacist teaching followed by a tailored online e-learning intervention~     post-discharge will lead to improved patient satisfaction, knowledge and medication~     adherence.~   "
94010|NCT01826591|"~     Genomics research is advancing rapidly, and links between genes and obesity continue to be~     discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in~     multiple genes have been shown to alter an individual's response to dietary macronutrient~     composition. Based on prior genetic studies evaluating the body's physiological responses to~     dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns~     with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype~     (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using~     the A TO Z weight loss study data), the investigators observed a 3-fold difference in~     12-month weight loss for initially overweight women who were determined to have been~     appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat)~     diet based on their multi-locus genotype pattern. The primary objective of this study is to~     confirm and expand on the preliminary results and determine if weight loss success can be~     increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an~     individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those~     diets.~   "
94011|NCT01826578|"~     This study is about the evaluation of which benefits single port laparoscopic myomectomy has~     in the perspective of cosmetics and patient satisfaction.~   "
94002|NCT01826708|"~     For every child with developmental delay, the investigators do a constitutional karyotype.~     This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss~     or gain of genetic material), such as a translocation between two or more chromosomes of~     accidental occurrence (not transmitted by parents). However, an apparently balanced~     translocation does not explain the phenotype of the child. Among the hypotheses that could~     explain the child's symptoms, there is the possibility of another chromosomal abnormality at~     the translocation breakpoints, another defect elsewhere on the chromosomes or gene~     disruption at or near the breakpoints. Because the resolution of a constitutional karyotype~     is limited, these microanomalies can go undiagnosed. The goal of this study is to look for a~     microanomaly on a chromosome using a technology of higher resolution than that of the~     conventional karyotype. The proposed study uses DNA microarray technology on DNA extracted~     from blood lymphocytes to perform high-resolution analysis of all chromosomes to search for~     an unbalanced microrearrangement (such as loss or gain of chromosomal material). If no~     microrearrangement is found, the investigators will pursue by looking for a gene disruption~     defect at or near the breakpoints involved in the translocation. This will be done by first~     isolating the chromosomes involved in the translocation by flow cytometry and then~     hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study~     is to find a possible cause to explain the phenotype (microrearrangement or gene~     disruption).~   "
94003|NCT01826695|"~     Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with~     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms~     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological~     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the~     general global population.~      Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this~     prospective study was to examine the combined effects of soft tissue mobilization and nerve~     slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.~   "
94004|NCT01826682|"~     Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be~     aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea~     and the quantity of sputum purulence). This is known as exacerbation and it is the most~     frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy~     program is carrying out in patients attending to the Hospital because of an exacerbation.~      The hypothesis of this study is that a physiotherapy program added to a medical treatment~     increase the ventilatory function, the physiques variables, decrease depression and anxiety~     and improve the quality of life. Additionally, it is going to be assessed the effect of~     physiotherapy in time using phone calls and visits to the patient's home.~   "
94005|NCT01826669|"~     The study hypothesis is chest wall muscle stretching increase distribution of volume~     variation of thoracoabdominal wall and reduce electromyographic activity of respiratory~     muscles in patients with Chronic Obstructive Pulmonary Disease.~   "
94006|NCT01826656|"~     Both the pathogenesis and the treatment of osteoporosis may potentially interfere at~     different levels on the multi-stage complex cascade of events involved in bone~     healing/regeneration. To our knowledge no human studies have been performed to clarify the~     potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of~     the study is to compare alveolar bone changes in width and height 3 months after tooth~     extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic~     women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes~     considered are: clinical changes in the external contour of the ridge and periodontal~     parameters in the neighbouring teeth after a tooth extraction and 3 months later. In~     addition the accuracy of panoramic morphometric indexes in detecting osteoporosis will be~     measured.~   "
94007|NCT01826630|"~     The primary objective of this protocol is to acquire pilot data for a larger study to test~     the following hypothesis: Treatment of the hands of patients with chronic hand~     dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed~     as a cosmetic product containing a dilute concentration of less than 0.01% sodium~     hypochlorite and less than 0.005% concentration as it is lathered, will result in a~     statistically significant reduction in the number of skin fauna present on the hands of~     these patients compared to treatment of such patients with traditional wash used clinically~     such as Cetaphil Daily Facial Cleanser.~   "
94008|NCT01826617|"~     This study will identify significant clinical parameters and individual risk factors related~     to certain prostate disease (BPH, prostatitis and prostate cancer). With the identified~     important correlations, a locally generated bias free nomogram will be constructed for~     predicting prostate biopsy outcome among Asian men with indications for prostate biopsy.~     While this study will evaluate the accuracy and predictive value of this novel prostate~     disease nomogram.~   "
94009|NCT01826604|"~     The purpose of this study is to investigate the effects of the Alexis O C-section retractor~     in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized~     to the use of the Alexis retractor during Cesarean section (treatment group) or the use of~     traditional hand-held retractors (control group). We will determine if there is any~     difference in surgical site infection or wound disruption rates. We will also determine if~     there is a difference in the duration of surgery or length of time from skin incision to~     delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length~     of stay, intra-operative or postoperative anti-emetic requirements, need for hospital~     readmission or emergency room visits, or other complication rate between the two groups.~   "
94012|NCT01826565|"~     To evaluate the efficacy of rotational technique in the insertion of i-gel~   "
94013|NCT01826552|"~     The purpose of this multicenter, randomized, open label, parallel arm study whether the~     newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the~     newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9~     months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart~     disease will be enrolled to this all-comers trial to give definite answer to the above~     hypothesis that is urgently needed.~   "
94014|NCT01826539|"~     As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the~     dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two~     donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.~   "
94016|NCT01826513|"~     The purpose of this study is to assess the efficacy and user preference of the Newport~     AutoSet for Her in female obstructive sleep apnea (OSA) patients.~      Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen~     desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.~      User preference will be evaluated by subjective feedback relating to comfort, ease of~     falling asleep, sleep disturbance and feeling of being refreshed.~   "
94017|NCT01826500|"~     The five proteins of the ITI (Inter-α-trypsin inhibitor) family, are essential components of~     the extracellular matrix, the dynamics of which they participate in the processes of~     cellular differentiation and proliferation. I. The ITIH1, ITIH2, ITIH3 and ITIH4 genes seem~     to be overwhelmingly expressed in the liver, this organ secreting then the corresponding~     proteins in the general circulation. The only data on ITIH5 indicate that this gene is~     poorly expressed in the liver and that the major source of its expression is the placenta.~     In the context of genetic studies on the syndrome of Mayer-Rokitansky-Küster-Hauser~     (congenital aplasia of the uterus and vagina), the investigators have shown the involvement~     of ITIH5 and implemented validation experiments of this gene in mice. The investigators have~     shown that the production of ITIH5 by the uterus varies greatly depending on the~     physiological state of this organ, especially during pregnancy and the estrous cycle. The~     investigators also found that most of the production ITIH5 was located in the uterus.~     Therefore, the serum dosage of ITIH5 could be used clinically as a new biological marker~     specific to the uterus. This non-invasive biological marker could thus assist in the~     diagnosis and the understanding of uterine pathologies. ITIH5 rate being correlated to~     endometrial proliferation, its dosage could be an early and non-invasive marker of~     endometriosis. The peak of production of ITIH5 by the uterus at the time of embryo~     implantation window indicates that the assay could provide a better assessment of~     endometrial receptivity to embryo. It then could be a hand tool of diagnosis in some cases~     of early repeated miscarriages, and secondly, a prognostic tool for embryo implantation in~     the context of in vitro fertilization.~      The investigators conducted an initial feasibility study on the serum dosage of ITIH5, which~     was approved by the ethics committee of the University Hospital of Rennes. This first step~     has been validated. Now, the project is to perform a quantitative analysis of ITIH5 and to~     correlate clinical and biological data of relevant pathological and physiological~     situations. This project was the subject of a national and international patents of which~     the University Hospital of Rennes is promoter.~   "
94018|NCT01826487|"~     Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which~     develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is~     important for maintaining normal muscle structure and function. Loss of dystrophin causes~     muscle fragility that leads to weakness and loss of walking ability. A specific type of~     mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy~     in approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense~     mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on~     walking ability. The effect of ataluren on physical function, quality of life, and~     activities of daily living will be evaluated. This study will also provide additional~     information on the long-term safety of ataluren.~   "
94019|NCT01826474|"~     The purpose of the study is to see whether PRO045 is safe and effective to use as medication~     for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA~     for the dystrophin protein.~   "
94020|NCT01826461|"~     This study will compare the safety and efficacy of three test article foams (PDI-192 0.1%~     Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be~     selected for future development.~   "
94021|NCT01826448|"~     The purpose of this research study is to test the safety of an investigational new drug~     called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose~     levels. Vemurafenib has been approved by the United States Food and Drug Administration~     (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of~     unresectable or metastatic melanoma.~   "
94022|NCT01826435|"~     The study team is proposing a single arm intervention to test the effect of an electronic~     intervention on medication use among individuals with a prescription for hypertension/high~     blood pressure. The investigator proposes that technology like text messaging, email, web~     applications and mobile apps with proven, nurse intervention scripts, will lead to~     significant, cost-effective improvements in hypertension medication use.~   "
94023|NCT01826422|"~     The purpose of this study is to evaluate the effect of the supplement with docosahexaenoic~     fatty acid and eicosapentaenoic fatty acid for six months in the inflammation states as well~     as the process of muscular regeneration and the metabolic disorders like obesity and insulin~     resistance on patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy~     (DMB) compared to those receiving placebo.~   "
94024|NCT01826409|"~     This study was conducted to investigate the effects of daily supplementation of fermented~     red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type~     2 diabetes.~   "
94025|NCT01826396|"~     In the current treatment of colon cancer, the definition of locally advanced colon cancer~     (LACC) is controversial, and the clinical trial evidence which support treatment for LACC is~     not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main~     chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also~     could be effectively applied for patients with locally advanced colon cancer? It is worthy~     of clinicians to conduct research. In recent studies, the literature indicated that the the~     uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes~     associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to~     delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study~     found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous~     variant genotypes was significantly lower compared with the wild genotype. The studies based~     on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At~     present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms~     has not yet come to the consistency of conclusions. The frequency of UGT1A1 gene~     polymorphisms between different races is significant different, irinotecan dose exploratory~     study based on Chinese patients has not been carried out.~      This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate~     of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of~     UGT1A1.~   "
94026|NCT01826383|"~     This study sets out to compare the effectiveness of a parent pain management coaching video~     that is 5-minutes in length. The investigators will be comparing an active-video to a~     placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month~     infants undergoing routine immunization. The investigators hypothesize the active video will~     result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase~     in the parental use of distraction, physical comfort, and rocking.~   "
94028|NCT01826357|"~     The metabolic syndrome (MetS) is a cluster of clinical indices that signals increased risk~     for cardiovascular disease and Type 2 diabetes. Women with polycystic ovary syndrome (PCOS)~     were associated with MetS and insulin resistance. Cluster analysis was a useful tool for~     identifying groups of women sharing similar metabolic risk factor patterns. Oligomenorrhea,~     hyperandrogenism and polycystic ovary morphology were the three major components of PCOS.~     Obesity is a main risk factor in metabolic syndrome. the investigators are interesting to~     evaluate the relationship between risk of metabolic syndrome and their clinical and/or~     biochemical characteristics in women with reproductive age.~      Design: Retrospective study; medical records reviewed. Participants and setting: The~     investigators retrospectively reviewed the medical records of female patients who visited~     our Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.~   "
94029|NCT01826344|"~     This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1~     year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and~     effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a~     short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion~     of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated~     Stent Graft and for whom a customised medical device is required.~   "
94030|NCT01826331|"~     One of the most important debates in the field of disease prevention is whether financial~     incentives should be contingent on participation in evidence-based programs for smoking~     cessation or on actual outcomes, like prolonged abstinence. This study can fill a major~     knowledge gap in this debate, which is the lack of any population trial that compared the~     impacts of outcomes- and participation-based incentives in a population of smokers. This~     research can help policy makers and health service providers choose the incentives approach~     that provides the most effectiveness, cost-effectiveness and cost-savings for entire~     populations of smokers.~   "
94031|NCT01826318|"~     This study assessed the impact of a task-focusing strategy on perceived stress levels and~     performance during a simulated CPR scenario.~   "
94032|NCT01826305|"~     In this study we plan to compare the efficacy of independent exercises performed by the~     patients at home to formal rehabilitation therapy following primary total knee replacement.~     Patients will be randomized to these two cohorts at enrollment into the study and followed~     prospectively. Patients randomized to the formal rehabilitation cohort will receive a~     prescription for therapy for twelve weeks. Patients randomized to the independent exercise~     cohort will receive online access to a twelve-week protocol of exercises to perform at home~     to strengthen and improve function of the replaced joint.~      At enrollment, a baseline evaluation will be conducted to capture demographics, height,~     weight, primary diagnosis, medical comorbidities, and social supports as well as completion~     of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis~     Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with~     use of the Short Form-12v2 (SF-12v2) and activity level with the University of California,~     Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up~     visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score~     questionnaires. Statistical analysis will be performed to compare the outcomes between the~     two cohorts.~      Hypothesis:~      There will be no difference in outcomes between formal rehabilitation and independent~     exercises at twelve months after primary total knee replacement surgery using the American~     Knee Society (AKS) Knee Score.~   "
94033|NCT01826292|"~     The investigators are conducting a retrospective, cross-sectional chart review of patients~     who underwent an anesthetic administered by an anesthesiologist in the University of~     California Davis main operating rooms and were transferred to the main post anesthesia care~     unit between January 1, 2012 and March 31, 2012. The investigators are excluding patients~     less than 18 years of age, patients transferred to the intensive care unit, and patients for~     whom data is not reported. Our aim is to report the incidences patient characteristics, as~     well as anesthetic and surgical techniques, and the associations these factors may have with~     the outcome of patient length of stay in the PACU.~   "
94034|NCT01826279|"~     The purpose of this study is to investigate potential metabolic effects of resveratrol in~     morbidly obese women undergoing gastric bypass surgery.~      The investigators hypothesize that resveratrol will:~        -  Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion~        -  Decrease hepatic and adipose tissue VLDL-TG uptake~        -  Increase insulin sensitivity~      The investigators will look at changes in:~        -  Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)~        -  VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous~          abdominal adipose tissue, visceral adipose tissue and liver tissue)~        -  Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)~        -  Regulation of liver fat handling~        -  Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)~   "
94035|NCT01826266|"~     PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable~     safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977~     that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care~     prothrombin time [PoC-PT]), and/or secondary biomarkers (thromboelastography reaction time~     [TEG-R]) will be identified.~   "
94036|NCT01826253|"~     Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output~     monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which~     consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The~     maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was~     too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion~     conducted for cardiac output maximalization, following actual guidelines.~   "
94037|NCT01826240|"~     The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT)~     + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine~     its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is~     to collect data on the cognitive changes underlying treatment gains.~   "
94038|NCT01826227|"~     The purpose of this study is to see if Positron Emission Tomography (PET) probes make it~     easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a~     wandlike device that can detect radioactivity.~   "
94042|NCT01826175|"~     Subjects with acute coronary syndromes scheduled for cardiac catheterization will be~     enrolled in this study. Subjects that are to be treated clinically with coronary artery~     stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after~     diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be~     performed after stenting and the presence of blood clots inside the new stent will be~     measured and compared between the groups.~   "
94043|NCT01826162|"~     Gut microbiota is being increasingly recognized as an important factor in fat distribution,~     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota~     could play an important role in the development of obesity and type 2 diabetes mellitus. The~     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by~     microbial fermentation of fibre, is still controversial. At the present time, our~     understanding of the effects of SCFA on human metabolism (in gut or systemically) is still~     limited. The investigators hypothesize that the differential availability of SCFA impacts~     human metabolism differently.~      In this placebo controlled, double-blind, randomized crossover pilot study the investigators~     will validate in overweight/obese healthy male volunteers whether rectal administration of~     SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be~     investigated if site of administration (in distal or proximal colon) of SCFA differentially~     affects parameters of substrate and energy metabolism and to test the duration of short-term~     effects of SCFA administration.~   "
94044|NCT01826149|"~     The purpose of this study is primarily to determine the effects of propofol at different~     concentration on the mitral valve annulus by using Tissue Doppler Imaging~   "
94045|NCT01826136|"~     Postoperative airway clearance and recovery of pulmonary function after lung resection is~     critical in patients undergoing pulmonary resection surgery. The investigators hypothesized~     that vibratory positive expiratory pressure using the Acapella device may improve pulmonary~     function recovery in patients undergoing video-assisted thoracoscopic lung resection~     surgery.~   "
94046|NCT01826123|"~     Recently, the investigators study group showed in a mono center study that Point of Care~     (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in~     perioperative care of coagulopathic cardiac surgery patients. The investigators aim to~     verify the obtained results by conducting this multicenter study.~   "
94047|NCT01826110|"~     The purpose of this study is to investigate the radiotracer [11C] PIB in participants with~     probably Alzheimer's Disease (AD) and healthy age-matched controls.~   "
94048|NCT01826097|"~     Can a commercially available vibrating chair increase the number of urothelial cells in a~     urine sample of healthy participants non-invasively? The investigators plan is participants~     will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting~     in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking~     eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour.~     Then, urine samples will be collected and examined for urothelial cell concentration for~     both groups.~   "
94049|NCT01826071|"~     The purpose of this study is to compare three different treatments for these types of lower~     extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson~     syndrome (SLJ), or Sever's disease.~      The investigators hypothesize that adolescents who perform a home exercise program (HEP)~     consisting of active elongation exercises will have decreased pain and earlier return to~     sports and activities as compared to those who perform a HEP that consists of static~     stretching exercises or those who use symptomatic treatment with ice, acetaminophen or~     NSAIDs and activity modification.~   "
94050|NCT01826058|"~     Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that~     requires to be treated promptly. Although direct decompressive surgery is the most effective~     treatment, surgery is only used in selected patients because most patients have a poor~     overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most~     commonly used for patients with MESCC, but conventional RT alone can achieve modest~     neurologic outcomes.~      The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid~     decompression of epidural mass, durable local control and subsequently improved neurologic~     outcomes compared to conventional RT are expected when MESCC is treated with SBRT.~   "
94051|NCT01826045|"~     The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma~     Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).~   "
94052|NCT01826032|"~     In the near future more than 20% of the European population will be over 65 years old and~     the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be~     higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but~     the relationship between cognitive impairment and sleep breathing disorders (SBD) in the~     elderly has scarcely been observed.~      The aim of this study is to investigate cognitive performance in elderly OSA patients, the~     corresponding brain morphology changes and biological markers and their reversibility with~     continuous positive airway pressure (CPAP) treatment.~   "
94053|NCT01826019|"~     The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and~     evaluate an evidence-based, contextually appropriate programme for cardiovascular disease~     (CVD) risk assessment, treatment and control involving: (1) simplified algorithms~     implemented by non-physician health workers (NPHW) and supported by e-health technologies~     (tablets programmed with decision and counselling support software); (2) initiation of~     evidence-based cardiovascular (CV) medications and (3) treatment supporters to optimize~     long-term medication and lifestyle adherence.~   "
94054|NCT01826006|"~     The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in~     acute myocardial infarction is described in up to 40% of cases. This event is associated~     with a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two~     main pathogenetic mechanisms cause no-reflow: distal embolization, ischemia-reperfusion~     injury and individual susceptibility. In such a context, Excimer Laser (EL) may play an~     important role in order to reduce the rate of microvascular obstruction.~      Thus, in this randomized study we will assess the effect of EL versus Manual Thrombus~     Aspiration for ST elevation MI using ST segment resolution on standard 12 leads ECG as~     primary endpoint of myocardial reperfusion.~   "
94055|NCT01825993|"~     The investigators would study the control of postoperative pain with peridural catheter,~     morphine PCA ev or Transabdominal block.~   "
94058|NCT01825954|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the management of fibromyalgia. Patients who meet the 1990~     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE~     treatments delivered by a medical device called NeuroPoint. Approximately 45 fibromyalgia~     patients will be randomized into one of three study groups. One of these groups will receive~     sham treatment, meaning they will receive no treatment at all, while the remaining two~     groups will receive different amounts of RINCE therapy. The study's primary outcome measure~     will be the patient's change from baseline in self-reported 24-hour average pain intensity.~     The study's hypothesis is that there will be a difference between treatment groups in~     primary outcome measure.~   "
94059|NCT01825941|"~     Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite~     the fact that data supporting this practice do not exist. The investigators propose a~     randomized double blind study to test the hypothesis that 50mg of intravenous~     diphenhydramine, when added to standard migraine therapy, will result in a greater rate of~     sustained headache relief than standard migraine therapy alone. For this study, standard~     migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is~     defined as achieving a headache level of mild or none within two hours and maintaining a~     level of mild or none for 48 hours. Patients who present to the Montefiore emergency~     room (Bronx, NY) with an acute migraine will be approached for participation. They will be~     screened for medication contra-indications and non-migraine etiologies of headache. The~     study will be randomized. Assignment will be concealed. Participants and researchers will be~     blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours~     in the ED and by telephone 48 hours after medication administration. A sample size~     calculation, based on pilot data, revealed the need for 374 participants. An interim~     analysis will be performed after 200 participants have been enrolled with the goal of~     assessing for lack of conditional power.~   "
94060|NCT01825928|"~     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for~     methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have~     effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors~     neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among~     methamphetamine addicts.~   "
94061|NCT01825915|"~     Observational studies suggest faster recovery and quicker return to normal activities~     following laparoscopic supracervical hysterectomy (LSH which involves removal of the body of~     the womb but conservation of the neck of the womb or cervix) compared with laparoscopic~     hysterectomy (LH in which both the body and neck of the womb are removed) in women with~     benign uterine disease. Data from the only randomised controlled trial (RCT) on the topic~     does not support this observation.~      The investigators set out to investigate the feasibility of a double blind RCT comparing~     post-operative recovery following LH with that following LSH.~      The investigators set out to recruit 50 participants from a single gynaecological surgeon's~     caseload. Web based randomisation was carried out at the time of study laparoscopy. Surgery~     was performed using a standardised technique.~      Participants and the data handler were blinded to treatment allocation (double blind study~     where neither the patient nor the surgeon have knowledge of treatment group allocation at~     the time of questionnaire analysis).~      Primary outcome is feasibility of recruitment to the study. The null hypothesis for this~     study is that 'a double blind, randomised controlled comparison of recovery following~     laparoscopic hysterectomy with recovery following laparoscopic sub-total hysterectomy' is~     not feasible.~      Secondary outcomes included validated post-operative recovery and mood questionnaires at~     baseline, prior to discharge and at weekly intervals for 12 weeks. Validated questionnaires~     regarding pelvic floor function and sexual function will be assessed at baseline, 6 weeks~     and 6 months.~      The findings of the feasibility study will inform the power calculation for a planned~     definitive study ( the magnitude of the differences found between the 2 arms of the~     feasibility study will allow calculation of the total number of participants required in a~     definitive study to allow demonstration of statistically significant differences in~     outcomes).~   "
94062|NCT01825902|"~     This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission~     tomography and diffusion-weighted magnetic resonance imaging in planing surgery and~     radiation therapy and measuring response in patients with newly diagnosed Ewing sarcoma.~     Comparing results of diagnostic procedures done before and after treatment may help doctors~     predict a patient's response and help plan the best treatment.~   "
94063|NCT01825889|"~     The purpose of this study is to measure how much of the study drug, evacetrapib, gets into~     the blood stream and how long it takes the body to get rid of it when given to participants~     with severe renal (kidney) impairment compared to participants with normal renal (kidney)~     function. This study will last approximately 8 weeks.~   "
94064|NCT01825876|"~     All study participants will receive both warfarin and a study drug called evacetrapib. The~     main purpose of this study is to look at how much warfarin gets into the blood stream and~     how long it takes the body to get rid of warfarin when given both with and without~     evacetrapib. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent~     blood clots when given with evacetrapib by measuring the time it takes for blood to clot and~     comparing it to an average of the international normalized ratio (INR). INR measures the~     time it takes for blood to clot and compares it to an average.~      The study will last approximately 5 weeks, not including screening.~   "
94065|NCT01825863|"~     Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years~     old. Ten percent of the population will get this disease during a lifetime. At Bispebjerg~     hospital it is one of the most common acute surgeries performed. Though at Bispebjerg~     hospital the surgery is only performed on adults as there is no pediatric ward. The surgical~     technique is primarily laparoscopic surgery, where the patients have their appendix removed~     while in general anaesthesia. During the last three years Bispebjerg hospital has had an~     average of 287 patients per year undergoing laparoscopic surgery. From January to the~     September 2012 a total of 211 patients have had the operation, with 29% having the operation~     performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only~     performed in cases where laparoscopic surgery is impossible, this is often due to adhesions,~     scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic~     surgery are usually smaller than that from an open appendectomy, but it gives the patient~     three smaller scars divided on three abdominal quadrants instead of one larger scar on one~     quadrant.~      The investigators want to conduct a clinical trial with fifty six patients undergoing~     laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is~     possible to improve the post-operative pain management within this very large group of~     patients undergoing acute surgery. In detail, the investigators wish to explore whether the~     use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery~     due to acute appendicitis, can anesthetize the patients completely or partially, so they can~     avoid morphine intake completely or partially during the post-operative phase (12-24 hours).~     The research project will be a randomized, double-blinded, controlled clinical trial.~   "
94066|NCT01825850|"~     The objective of the study is to investigate the drug interaction between Gemigliptin and~     Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered~     concomitantly and each alone in healthy male subjects.~   "
94244|NCT01823536|"~     In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody~     persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to~     10 years of age, and to evaluate response to a booster dose administered 5 years after~     primary vaccination in the parent study V59P20 (NCT00616421).~   "
94067|NCT01825837|"~     This was an extension study consisting of 2 parts. In Part I, all participants received~     open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a~     double-blind, parallel-group design in which participants were randomly assigned to~     treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission~     continued double-blind therapy until approximately 6 months after the last patient entered~     Part II.~   "
94068|NCT01825824|"~     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic~     resection or liver transplantation, but less than 20% of HCC patients are suitable for~     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial~     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete~     response and commonly develops recurrence. Recently several small studies reported high~     tumor response and local control rate after stereotactic ablative radiotherapy (SABR) alone~     or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3~     fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.~   "
94069|NCT01825811|"~     The purpose of this study is to determine whether TissueGene-C, allogeneic human~     chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is~     effective and safe in patients with degenerative arthritis.~   "
94070|NCT01825798|"~     The purpose of this study is to determine whether metformin is safe and effective in the~     treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who~     are currently taking atypical antipsychotic medication.~   "
94071|NCT01825785|"~     This multicenter, randomized, double-blind, placebo-controlled, ascending multiple dose~     study assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     subcutaneous administration of 6 doses of 1 mg/kg AMG 785 once every 2 weeks or 3 doses of 3~     mg/kg AMG 785 every 4 weeks in healthy men or postmenopausal women with low bone mass and 3~     doses of 2 mg/kg AMG 785 every 4 weeks or 6 doses of 2 mg/kg AMG 785 every 2 weeks in~     healthy postmenopausal women with low bone mass.~   "
94072|NCT01825772|"~     900 subjects having received dental implants 9-10 years ago are invited for a clinical and~     radiographic examination. The individuals were randomly selected from the National Health~     Insurance data register in Sweden.~      The clinical and radiographic examination of the 900 selected subjects will include~     assessments of implant loss, loss of prosthesis and technical / biological complications.~      Biological complications will be assessed from the findings in the clinical and radiographic~     examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD)~     and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in~     radiographs will also be evaluated.~      The prevalence, extent and severity of peri-implantitis will hereby be determined.~     Patient-centered outcomes will also be obtained.~   "
94073|NCT01825759|"~     The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and~     artery structure and function in patients with hypertension~   "
94074|NCT01825746|"~     The purpose of this delayed cluster randomized intervention trial is to evaluate primary~     care strategies to increase goal setting, shared decision-making and evidence-based support~     and counseling for health behaviors and psychosocial issues through the implementation of a~     standard set of practical, patient-centered survey items and related decision support tools,~     called the My Own Health Report (MOHR) assessment. Nine pairs of diverse primary care~     practices will participate, four pairs of federally qualified health centers clinics and 5~     pairs of practice based research network practices. Practice pairs are similar in size,~     patient and staff mix, culture, and level of EHR integration. Within pairs, practices will~     be randomized to early or delayed intervention (4 months later). The intervention consists~     of implementing the MOHR assessment and patient counseling into clinical care for all~     patients presenting for wellness or chronic care during a 6 month study period. Prior to~     implementation, practices will receive brief training about health behavior counseling, goal~     setting, and action planning. Practices will also be provided materials to support~     evidence-based counseling and referrals to local community resources. MOHR assessment~     implementation details will be determined by each practice pair but will generally include~     (1) asking patients to complete the MOHR assessment on the web prior to encounters~     (available at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and~     psychosocial issues including physical activity, diet, alcohol consumption, tobacco use,~     drug use, sleep, stress, depression and anxiety), (2) provision, via the tool, immediate~     patient feedback that includes identification of unhealthy issues, assessment of readiness~     to change, prioritization of issues to change, and preparation for goal-setting and action~     planning, (3) feedback to the primary care team on the patient status and priorities for~     change, (4) provision of counseling, goal setting, and referrals to local resources by~     clinicians during the subsequent office visit, and (5) follow-up with the clinicians and~     local resources as agreed upon by the patient and clinician. Data sources will include~     patient responses to the MOHR assessment, practice appointment records, and a patient~     experience survey mailed to the first 300 patients offered the MOHR assessment two weeks~     after their office visit. Primary outcomes will include the Reach and Effectiveness of the~     intervention. Reach will be assessed in early and delayed intervention sites when they field~     the MOHR assessment. Effectiveness will compare early and delayed intervention sites during~     the early intervention phase, allowing the delayed intervention sites to serve as controls.~     Reach outcomes will include the percent of eligible patients receiving and completing the~     MOHR assessment. Effectiveness outcomes will include the percent of patients reporting that~     they were asked about health topics, set a change goal, received assistance for making a~     change, were referred for local counseling and support, and/or made any changes. Additional~     outcomes will include maintenance of the MOHR assessment implementation beyond 4 months,~     changes in patient reported health behavior and psychosocial measures by repeated~     administration of the MOHR assessment 4 months after initial completion, qualitative~     assessments on implementation factors and context that influence outcomes, and cost, in~     terms of time and resources required for practices to implement the MOHR assessment.~   "
94075|NCT01825733|"~     Postoperative pain, the great concern for the patients undergoing spine surgery, has led to~     common use of opioid-based intravenous patient-controlled analgesia (IV-PCA)~     postoperatively. Opioid-based IV-PCA offers better pain control, which could facilitate~     early recovery, rehabilitation and increase patient satisfaction. However, its use~     inevitably increases the incidence of postoperative nausea and vomiting (PONV), another~     great discomfort, as high as 80% in patients with multiple risk factors.Therefore, there~     have been consistent efforts to prevent PONV with multimodal therapies such as risk~     stratification, modification and preventive use of antiemetics.~      Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most~     commonly used and extensively studied to reduce PONV because of its efficacy and fewer side~     effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated~     with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy~     between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and~     palonosetron. Ramosetron is known to have a higher affinity and longer duration of binding~     to 5-HT3 receptor, therefore exhibits potent and sustained anti-emetic effect than~     previously developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the~     5-HT3 receptor, which brings a higher affinity, longer duration of action and longer~     elimination half-time.According to the previous studies, both ramosetron and palonosetron~     showed superior antiemetic efficacy for PONV associated with opioid-based IV-PCA to~     ondansetron as expected by their theoretical advantages. However, it has never been~     evaluated which one has superior antiemetic efficacy for opioid-based IV-PCA associated~     PONV. Therefore, in this study, we tried to evaluate the relative antiemetic efficacy of~     ramosetron and palonosetron in controlling opioid-based IV-PCA related PONV.~   "
94076|NCT01825720|"~     Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to~     be associated with hemodynamic instability, organ dysfunction and increased postoperative~     morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an~     adjuvant therapy in patients with myocardial infarction or in the patients undergoing~     valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known~     to prevent excretion of lactate and to increase the extraction of lactate after reperfusion~     with various mechanism. In addition, it is also known to decrease ischemic-reperfusion~     injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and~     hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to~     the tissue, which might reduce the incidence of hyperlactatemia after valvular heart~     surgery.~   "
94077|NCT01825707|"~     The purpose of this study is to determine the absorption, metabolism, and excretion (AME)~     kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine,~     and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi)~     administered as a single oral dose.~   "
94078|NCT01825694|"~     This study plans to develop an integrated treatment for comorbid post-traumatic stress~     disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a~     treatment approach that is community-friendly, well-tolerated, and deliverable by substance~     abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse~     Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills.~     The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral~     Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to~     assess the acceptability and feasibility of the integrated approach; and to pilot test the~     new program against standard care.~      The investigators hypothesize that the intervention group, compared to the control group,~     will reduce substance use and symptoms for traumatic stress.~   "
94100|NCT01825408|"~     The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics~     as part of maximal medical therapy for treating chronic sinusitis and thus preventing~     patients from having to have sinus surgery. The hypothesis is that in the context of maximal~     medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at~     successfully treating chronic sinusitis.~   "
94079|NCT01825681|"~     Life Enhancing Activities for Family Caregivers is a six-week program designed to increase~     positive affect in people who care for a family member with dementia. The intervention~     consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to~     teach simple skills that are practiced at home in a study-supplied workbook. The program is~     preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be~     conducted at 1-month, 3-months, and 6-months post intervention.~      Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate~     significantly greater improvements in psychological outcomes and will engage in more problem~     focused and positive appraisal forms of coping compared to the wait-list control condition.~   "
94080|NCT01825668|"~     The overall goal of this clinical study is to investigate how dietary cholesterol intake~     influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol~     metabolism between adults who had been breast-fed as infants as a function of the duration~     of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate~     the effect of a plant sterol formulation in low fat milk shake in modulating the lipid~     profile favorably in the study population.~   "
94081|NCT01825655|"~     The purpose of this study is determine if long acting antihistamine like cetirizine can help~     with itching induced by opioid pain medications.~   "
94082|NCT01825642|"~     Surgical removal of the prostate (radical prostatectomy) is a common and generally effective~     treatment for prostate cancer. However, standard prostatectomy can affect urinary continence~     and sexual function. Different surgical techniques, such as nerve-sparing prostatectomy and~     seminal vesicle-sparing prostatectomy, may limit these treatment-related effects. In a~     standard prostatectomy, the seminal vesicles are removed completely. In contrast, during a~     seminal vesicle-sparing prostatectomy, the surgeon leaves a portion of the seminal vesicles~     intact. This is done because the nerves that are important to urinary continence and~     erectile function are located close to the seminal vesicles. The purpose of this study is to~     determine whether patients who undergo nerve-sparing prostatectomy with seminal~     vesicle-sparing experience better urinary and sexual functioning after surgery than patients~     who undergo standard nerve-sparing prostatectomy.~   "
94083|NCT01825629|"~     The purpose of this study is to determine the efficacy of a multidisciplinary therapy with~     physical, manual and deontology therapies in the treatment of temporomandibular joint~     dysfunction in patients with fibromyalgia syndrome.~   "
94084|NCT01825616|"~     Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D~     Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle~     function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative~     burst activity), and attenuate exercise-induced muscle damage and DOMS.~   "
94085|NCT01825603|"~     This phase I trial studies the side effects and best dose of ADH-1 when given together with~     gemcitabine hydrochloride and cisplatin in treating patients with metastatic pancreatic or~     biliary tract cancer that cannot be removed by surgery. ADH-1 may stop the growth of cancer~     cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving ADH-1 together with~     gemcitabine hydrochloride and cisplatin may kill more tumor cells.~   "
94086|NCT01825590|"~     A difference between dialysate and serum sodium concentration leads to diffusive sodium~     transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the~     patient can be chronic sodium overload leading to overhydration, hypertension,~     cardiovascular disease, and other problems. Diffusive sodium flux out of the patient can~     lead to intradialytic blood pressure instability. A simple strategy for alignment of~     dialysate and serum sodium concentrations was implemented starting in April/May 2010 in~     order to minimize the problems particularly associated with chronic sodium overload.~   "
94087|NCT01825577|"~     Falls in the elderly are a very common and serious health problem with devastating~     consequences. Those with dementia are 5 times more likely to experience falls than older~     people without significant cognitive impairment. Despite a growing awareness and the use of~     available treatments, the number of falls and fall related injuries continue to increase. It~     is important to develop more effective treatments to help reduce the number of falls and~     prevent injury. The assessments used in this study determine fall risk which predicts the~     likelihood of falls in the future.~      This study will evaluate the possible role of Methylphenidate, Ritalin, in preventing falls~     and improving symptoms of apathy, or indifference. Methylphenidate is FDA approved for the~     treatment of ADHD but is not currently approved by the FDA for preventing falls or improving~     apathy(lack of interest) in the elderly. The methylphenidate used in this study will be~     absorbed through the skin by wearing a small patch near the hip area.~      The specific primary aim of this open label study is to determine if use of transdermal~     Methylphenidate (t-MPH) causes a reduction in fall risk in patients with dementia.~      The hypotheses to be tested is that after receiving t-MPH for 4 weeks, subjects will show~     improvement in gait and mobility assessment scores when compared to gait and mobility scores~     at screening.~   "
94088|NCT01825564|"~     Replacing a G tube and placing feeding tubes is standard in the Emergency Department (ED)~     and ICU, respectively. However placement requires a chest or abdominal x-ray to confirm~     correct position. The investigators are testing the accuracy of the FDA approved devices~     RightSpot pH Indicator & RightLevel pH Detector in determining correct position based upon~     pH which will then be correlated with the standard of care x-ray.~   "
94089|NCT01825551|"~     The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor~     (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.~   "
94090|NCT01825538|"~     To understand current practices of pulmonary physicians in relation to Advanced Care~     Planning (ACP) in order to develop future disease-specific tools that will improve~     patient-physician communication about ACP.~   "
94101|NCT01825395|"~     To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with~     Lambert-Eaton myasthenic syndrome (LEMS).~   "
94245|NCT01823523|"~     Currently there is debate in the literature as to the recommended length of postoperative~     antibiotics in patients undergoing orthognathic surgery. The investigators plan to~     investigate using a randomized controlled trial the comparison between a 1 day and 3 day~     regimen of antibiotics and the effects on post operative infection.~   "
94091|NCT01825525|"~     The Olympus ScopeGuide® is a useful tool in speeding up colonoscopy and making it less~     painful for patients. It is currently contraindicated by the manufacturer for use with~     patients with implantable electronic devices (such as cardiac pacemakers). There is no~     evidence to back up this contraindication and with the number of pacemakers being inserted~     increasing by around 30 000 annually in the UK, more patients will be denied the use of this~     device should they require a colonoscopy.~      Participants with Pacemakers or Implantable Cardioverter Defibrillators will attend their~     check appointment. Following this they will be asked to lie with a colonoscope connected to~     the ScopeGuide® placed onto their abdomen (with clothes on) for 2 minutes. During this time~     they will be monitored for any irregular cardiac activity which may indicate electromagnetic~     interference. After this a second device check will occur and the participant will be sent~     home.~      The hypothesis is that the ScopeGuide will not interfere with the cardiac devices.~   "
94092|NCT01825512|"~     Haemoglobinopathies are a group of inherited disorders characterized by structural~     variations of the haemoglobin molecule. Most of the patients affected require for survival~     chronic red blood cells transfusions to overcome ineffective erythropoiesis. Unfortunately,~     all chronically transfused patients become clinically iron overloaded as there is no~     physiological mechanism for the removal of iron from the body. The pathologic changes and~     clinical manifestations associated to chronic iron overload are common among all~     transfusional iron-overload patients, albeit best documented in patients with~     beta-thalassemia major. The recommended treatment consists in regular blood transfusions~     combined with chelating therapy to remove the harmful iron accumulation in the body.~      Currently, in the clinical practice particularly in children and adolescents, the criteria~     leading to the choice of the chelating agent include also the adherence to therapy, thus~     favouring the use of oral chelators (Ceci A et al., 2011) DFP (Deferiprone) was the first~     oral chelator authorised in Europe in 1999 as second line treatment for the treatment of~     iron overload in patients with thalassaemia major when DFO (Deferoxamine) is contraindicated~     or inadequate. However, despite a wide experience of DFP with iron overloaded (specifically~     thalassaemic )patients, limited data are available for younger children. For this reason the~     need for additional data in younger children is expressively included in the 2009 PDCO~     (Paediatric Committee) Priority List.~      The purpose of this study is to assess the non-inferiority of DFP compared to DFX~     (deferasirox)in paediatric patients affected by hereditary haemoglobinopathies requiring~     chronic transfusions and chelation. Non inferiority will be established in terms of~     percentage of patients successfully chelated, as assessed by serum ferritin levels (in all~     patients) and cardiac MRI T2* (in patients above 10 years of age able to have an MRI scan~     without sedation).~   "
94093|NCT01825499|"~     Vermont Oxford Network maintains a database for live born infants 401 to 1500 grams or 22 to~     29 weeks gestational age who are born at participating hospitals or admitted to them within~     28 days of birth, regardless of where the infant receives care.~   "
94094|NCT01825486|"~     Background: Accidental falls result in major physical and psychological morbidity in the~     elderly, especially stroke patients. To get optimal prevention of stroke falls, it is~     crucial to identify independent risk factors from multivariate analysis of related balance~     and gait parameters.~      Aim: To evaluate the effects of balance and gait characteristics in determining whether or~     not accidental falls may happen. To investigate if the balance and gait parameters affect~     the time from lesion to when (and if) patients suffer from falls. To compare differences of~     balance and gait parameters in accidental fall patients between those with severe accidental~     injuries and those without severe injuries.~      Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who~     have not had a previous stroke. They will be retrieved from the Inpatient department and~     followed-up regularly in the Outpatient department when they are discharged. All subjects~     will be evaluated at 1 month and 6 months after stroke. These evaluations will include:~     mental, cognition and depression status; lower-limb muscle strength assessed by a~     dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry;~     functional independence measure; balance and gait pattern will be assessed by both clinical~     observation and objective laboratory examination (a dynamic posturography and computerized~     gait analysis system); falls and fall-related injuries during the proceeding year.~     Differences in baseline characteristics are tested by one-way ANOVA, Mann Whitney U or t~     tests, if appropriate. The investigators will identify the independent risk factors of~     accidental falls with logistic regression and use the log rank statistic of Kaplan-Meier~     survival curve to differentiate the risk of accidental falls or fall-related injuries in~     different groups.~   "
94095|NCT01825473|"~     To evaluate the relationship of reflux and apnea and to determine whether the administration~     of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or~     desaturation events in a prospective randomized controlled trial.~   "
94096|NCT01825460|"~     The purpose of this study is to determine the short-term effects of a manual therapy~     protocol on pain, disability and cervical range of motion in individuals with acute whiplash~     injury.~   "
94097|NCT01825447|"~     The main purpose of this study is to simulate if oxycodone and naltrexone combination~     capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously~     for the purpose of getting high.~   "
94098|NCT01825434|"~     Background and aims:Constipation is a frequent complaint and the combination of a prebiotic~     and probiotics would have a potentially synergic effect on the intestinal transit. The~     present study therefore aims to investigate the combination of polydextrose (Litesse®), L.~     acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who~     suffer from constipation.~      Methods: Patients with constipation were randomly divided into two groups, Placebo Group~     (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for~     14 days. Those in the CG received only yogurt, while the TG received yogurt containing~     polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513).~     Expect that patients who took a combination of polydextrose has a decrease in the colonic~     transit time (CTT) when comparing initial and final transit time.~   "
94099|NCT01825421|"~     Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences~     including development of necrotizing enterocolitis (a serious, potentially life-threatening~     gastrointestinal illness in premature babies), late-onset infections, resistance to~     antibiotics, increased length of hospital stay, and death.~      Starting and continuing antibiotic therapy for blood culture-negative infections in the~     neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying~     from 20%-90% of infants undergoing a sepsis evaluation in the NICU.~      While blood culture results are the gold standard, there is usually a delay of up to 48-72h~     before the results are known. Hence, initiation and continuation of antibiotic treatment are~     usually based on clinical evaluation and blood count criteria which do not possess high~     specificity or sensitivity, and may be unreliable in the first few hours after birth or in~     the early stages of infection.~      Since the investigators found that neutrophil CD64 (a type of protein found on the surface~     of a type of white blood cell that can be detected quickly in a very small amount of blood~     sample) has high accuracy for early detection of blood culture-proven infections in newborn~     babies, with extremely high negative predictive value (can identify babies definitively with~     no infection), the investigators will use this test to decide whether to stop or continue~     antibiotics in the NICU.~      The investigators hypothesis is that neutrophil CD64 values can be safely used to~     discontinue antibiotics in newborns suspected of having infections.~      The investigators aims are to utilize sequential measurements of CD64 values to stop~     antibiotics early in neonates being investigated for both early and late-onset infections in~     the NICU.~      This is a prospective, randomized, controlled (RCT) trial. The study population will be~     derived from the sub-set of all newborn infants who have undergone investigations for~     presence of infection in the NICU.~   "
94137|NCT01824927|"~     Patients having cataract extraction in the second eye under topical anesthesia with~     monitored anesthesia care often report increased pain and awareness relative to the first~     surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose~     of this study is to investigate the pathogenesis of this phenomenon.~   "
94102|NCT01825382|"~     The goal of this prospective pilot study is to evaluate the use of remote technology~     (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes,~     and a hypoglycemia fear questionnaire. In the future, this study might lead to investigating~     the role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the~     number of patients with T1D continues to increase, and such technology could conceivably~     help compensate for the shortages of endocrinologists providing care.~   "
94103|NCT01825369|"~     Infants with congenital heart disease and increased pulmonary blood flow have altered~     carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment~     will attenuate these alterations and improve clinical outcomes.~      The investigators will pilot a trial assessing the safety and pharmacokinetics of~     perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical~     trial is proposed. Infants with ventricular septal defects or atrioventricular septal~     defects undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg,~     IV) just prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be~     measured before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose.~     The safety, pharmacokinetic profile, feasibility, and effect of L-carnitine administration~     on biochemical parameters, as well as clinical outcomes will be determined. The~     investigators expect this pilot to provide the data needed to proceed with a placebo-based~     randomized, controlled, trial.~   "
94104|NCT01825356|"~     The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy~     procedure with implementation of amniotic membrane tissue results in improved clinical and~     functional outcomes compared to a standard dorsal cheilectomy procedure.~      Specific Aim 1:~      To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients~     undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of~     amniotic membrane tissue.~      Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior~     to those without.~      Specific Aim 2:~      To compare range of motion between patients undergoing dorsal cheilectomy to patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.~      Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane~     tissue will demonstrate less postoperative stiffness as measured from the pre-and~     postoperative radiographs.~      Specific Aim 3:~      To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy~     to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.~      Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior~     to those without.~   "
94105|NCT01825343|"~     Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical~     Centre with injuries of all systems, major and minor, in order to determine the exact~     circumstances of the injury, whether this might have been preventable and design a Haddon~     Matrix of risk factors for injury to target prevention.~      Hypothesis: injury prevention interventions can be targetted by finding out local causes of~     Paediatric Trauma~   "
94106|NCT01825330|"~     The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The~     NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.~   "
94107|NCT01825317|"~     Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer~     for the treatment of Alzheimer patients.~   "
94108|NCT01825304|"~     Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory~     transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung~     injury/acute respiratory distress syndrome will appear. In the group of people who suffering~     intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate~     the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of~     ALI/ARDS, which may decrease morbidity in this population.~   "
94109|NCT01825291|"~     The purpose of this study is to investigate the effectiveness of CPAP treatment to~     co-morbidities of sleep apnea by looking the change of the consumption of medication of the~     co-morbidities before and after starting the CPAP treatment.~   "
94110|NCT01825278|"~     This study proposes to evaluate the clinical applicability of the ExSpiron Respiratory~     Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical~     patients undergoing general anesthesia. Previous work has demonstrated the ability of the~     ExSpiron monitor to provide non-invasive, real-time, continuous measurements of respiratory~     parameters such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR)~     mostly in normal weight patients but those studies did not specifically look at obese~     subjects. Respiratory depression, in the postoperative setting due to residual anesthetics~     and/or opioid administration, continues to be a significant cause of adverse outcomes. Obese~     patients are at increased risk for respiratory complications. Currently, there is no~     objective measure of early respiratory indicators for developing respiratory compromise.~     Current respiratory assessment in non-intubated patients relies on oximetry data and~     subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing~     oxygen desaturations but it is a late indicator of respiratory decline. There is no current~     device capable of giving real time ventilatory information such as tidal volume and minute~     ventilation of a patient that is not mechanically ventilated. The ExSpiron system utilizes~     an impedance based technology and proprietary algorithms (Respiratory Motion Inc.) to obtain~     these measurements. The study hypotheses are that the non-invasive, impedance-based RVM~     monitor will accurately reflect TV, RR and MV in obese surgical patients before induction of~     general anesthesia, during controlled ventilation and following extubation; that ExSpiron~     will accurately reflect the post-extubation respiratory status of the patient; and that~     apnea and hypopnea episodes in the recovery room as detected by the ExSpiron monitor are~     correlated with the individual risk for obstructive sleep apnea as determined by the~     STOP-Bang risk stratification.~   "
94111|NCT01825265|"~     Primary:~        -  To assess the safety and tolerability and to find the maximum tolerated dose of the~          combination administration of RAD001 plus docetaxel when given to patients with~          metastatic breast cancer who are being considered for standard docetaxel treatment~          (phase I).~        -  To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered~          (phase I).~      Secondary:~        -  To assess the clinical efficacy of the combination regimens in this patient population~          as shown by response (according to the modified RECIST criteria) (phase II).~        -  To determine the phosphorylation status of the components of the mTOR signaling pathway~          and the expression of modifiers of apoptosis in the primary breast tumors, in order to~          determine whether these markers can be used as predictors of sensitivity to the~          combination of RAD001 and docetaxel~        -  To determine the effect of the combination of RAD001 and docetaxel on the expression~          and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to~          identify potential pharmacodynamics markers of response to this drug combination~   "
94112|NCT01825252|"~     During the formative research phase, investigators will undertake formative studies to~     locate, understand, and characterize high-risk social networks of African American MSM in~     the community; gain community participation, involvement, and input; and undertake~     interviews with key informants and community members to gain information needed to pilot~     test study recruitment procedures, measures, and intervention content.~      During a 4-year main outcome trial phase, the investigators will enroll 24 separate~     sociocentric (bounded) social networks composed predominantly of Black MSM. Each~     sociocentric network will consist of the ring of friends surrounding an initial high-risk~     index as well as all friends surrounding persons in this second ring and then friends~     surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network~     is expected to consist of approximately 40 unique members (n=24 networks, each with 40~     members = approximately 960 individual participants).~      All participants will be assessed at baseline to measure sexual practices, substance use,~     and other risk characteristics over the past 3 months; asked to provide biological specimens~     to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in~     HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for~     treatment.~      The investigators will identify the individuals in intervention condition networks with the~     greatest number of reciprocal interconnections and the most favorable sociometric standing~     in the network. These individuals--expected to constitute approximately 20% of the~     sociocentric network and designated as network leaders--will be recruited to attend a~     9-session program that provides training and guidance in how to deliver on-going,~     theoretically-based, and culturally tailored risk reduction advice and counseling to other~     members within the same network.~      Six and 18 months following the intervention, all participants will be reassessed on risk~     behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with~     positive STD and HIV cases respectively treated or referred to care at each assessment~     point. Outcome analyses will test whether there is greater reduction in high-risk sexual~     practices, substance use associated with risky sex, and HIV/STD incidence within social~     networks in the intervention condition. The primary trial endpoints are reductions in~     prevalence and frequency of unprotected anal intercourse with nonexclusive partners,~     increased condom use, and lower incidence on a composite biological measure of new HIV/STD~     disease during the followup period.~   "
94113|NCT01825239|"~     Presently, the left ventricular lead is placed in a similar position for all patients. It is~     not known whether placing this lead in different positions in the heart will make the heart~     pump better. In this study, the investigator will collect measurements of the heart's~     electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that~     these measurements will provide the know how to develop an individualized left ventricular~     lead placement prescription for patients referred for left ventricular lead pacing.~   "
94114|NCT01825226|"~     Helen Keller International (HKI) has been implementing homestead food production (HFP)~     programs in Asia for the past 20 years and has recently begun implementing HFP programs in~     Africa as well. In general, these programs target women and are designed to improve maternal~     and child health and nutrition outcomes through three primary pathways: 1. Increasing the~     availability of micronutrient-rich foods through increased household production of these~     foods; 2. Raising income through the sale of surplus production; and 3. Increasing knowledge~     and adoption of optimal nutrition practices, including the consumption of micronutrient-rich~     foods. Evaluations of HFP programs have consistently demonstrated significant increases in~     household production and consumption of micronutrient-rich foods. This increased~     consumption, along with improvements in health and nutrition related knowledge, and~     increased income, could all contribute to improvements in maternal and child health and~     nutrition outcomes. However, to date there has been limited understanding as to how these~     types of programs can be optimized to maximize impacts on these outcomes.~      In order to better understand the potential of these types of programs to improve maternal~     and child health and nutrition outcomes and how this impact may be achieved IFPRI has been~     collaborating with HKI to evaluate one of their E-HFP programs in Burkina Faso. The~     evaluation considers impact of the program through the three pathways above, and assesses~     anthropometric and clinical measures of nutrition, as well as looking at how the programs~     might be improved.~   "
94115|NCT01825213|"~     The purpose of this study is to improve stratification of patients with chronic liver~     disease through non-invasive detection and characterization of small liver tumors and liver~     fibrosis by means of using multi spectral CT.~   "
94116|NCT01825200|"~     The hypothesis for this trial is that the incidence of a pre-defined composite of common~     systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that~     reported for licensed IIV recipients. Another hypothesis is that the safety and~     reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety~     profiles previously observed with Flublok and with the licensed comparator.~   "
94117|NCT01825187|"~     The purpose of this research study is to measure the clinical effectiveness of two different~     polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length~     of hospital stay, perioperative complications, recurrence rate, pain score, comfort level~     and postoperative quality of life. A secondary goal of the study is to evaluate the ease of~     use and time it takes surgical residents to place the mesh and perform the surgery using~     these two different meshes.~   "
94118|NCT01825174|"~     The purpose was to investigate the consequences of pediatric overweight on the~     musculoskeletal system, postural control and proprioception, and to analyze prospectively~     the influence of ball games and nutrition counseling.~   "
94119|NCT01825161|"~     The main purpose of this study is to utilize a comprehensive, prospective clinical database~     to collect patient, diagnostic and treatment variables along with disease specific and~     generic health related quality of life (HRQOL) data on consecutively treated patients with~     metastatic spine tumors. The objectives are to determine the validity and reliability of the~     Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor~     outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a~     valid tool for predicting the stability of spine in metastatic spine disease, and to~     determine the efficacy of surgery versus radiotherapy for the treatment of impending~     instability secondary to metastatic disease of the spine.~   "
94120|NCT01825148|"~     The purpose of the study is to determine whether there are differences in pancreatic uptake~     of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D~     patients have a markedly reduced uptake, the compound may be suitable for estimation of~     pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.~   "
94121|NCT01825135|"~     The primary aim of this proposal is to test the effectiveness of NMES in improving~     functional status and muscle function in patients requirng prolonged mechanical ventilation~   "
94122|NCT01825122|"~     To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking~     cessation in patients with chronic cough associated with long-term smoking, with or without~     airflow obstruction, including those with established chronic obstructive pulmonary disease~     (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared~     to placebo and standard of care, while undergoing a validated smoking cessation program.~   "
94123|NCT01825109|"~     Rotavirus is the leading cause of severe gastroenteritis in infants and young children~     worldwide and is estimated to account for 600,000 deaths in children <5 years of age.~     However, live oral enteric vaccines (e.g. OPV, cholera vaccines, typhoid vaccine) have been~     less immunogenic in poor communities with high levels of malnutrition and poor sanitation.~     Rotavirus vaccines also appear to be less immunogenic in the setting where they are most~     needed. High maternal antibody (IgG) to rotavirus and breast feeding near the time of~     vaccination may inhibit rotavirus vaccine effectiveness. We propose a quick study to look at~     practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in~     Bangladesh. The objectives are to assess if delaying Rotarix vaccination will improve the~     immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes~     before and after vaccine administration will improve the immune response to administration~     of Rotarix vaccine. The study will be conducted in the urban Dhaka Mirpur Community, a~     setting where previous rotavirus vaccine immunogenicity studies have been successfully~     conducted. A total of 300 infant will be randomly assigned to one of the following groups:~     1) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine~     with no intervention in normal breastfeeding practices before and after receiving vaccine.~     2) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.~     Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45~     minutes after each vaccine administration. 3) Administration of Rotarix at 14 and 18 weeks~     co-administered with oral polio virus, with no intervention in normal breastfeeding~     practices before and after receiving vaccine. 4) Administration of Rotarix at 14 and 18~     weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes~     prior to vaccine administration and 45 minutes after each vaccine administration. Blood and~     stool samples will be collected from infants and breast milk from mothers. The primary~     outcome is to determine the sero-conversion rate of anti-rotavirus IgA in different groups~     of infants.~   "
94124|NCT01825096|"~     The principal advantages of functional magnetic resonance imaging (fMRI) with~     blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are:~     non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and~     the ability to map function over the entire brain. Thus, BOLD fMRI is the most widely~     applied technology to study healthy brain function and pathophysiology associated with~     disease. In studies of drug abuse and psychiatric illness though, normal assumptions mapping~     BOLD signals to neurometabolism may be violated. Generally, these effects are ignored,~     resulting in large study-to-study variability.~      Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of~     drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral~     metabolism during brain activation during visual stimulation measured with a new fMRI~     approach that is simple enough for clinical applications will be compared to CMRO2~     activation measured using standard qfMRI.~   "
94125|NCT01825083|"~     Procedures performed under sedation have the same severity in regards to morbidity and~     mortality as procedures performed under general anesthesia1. The demand for anesthesia care~     outside the operating room has increased tremendously and it poses, according to a closed~     claim analysis, major risks to patients. Both closed claim analysis identified respiratory~     depression due to over sedation as the main risk to patients undergoing procedures under~     sedation. The major problem is that hypoventilation is only detected at very late stages in~     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,~     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.~      The incidence of anesthetized patients with obstructive sleep apnea has increased~     substantially over the last years along with the current national obesity epidemic. These~     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The~     context of the massive increase in procedural sedation and the extremely high prevalence of~     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near~     future, increase malpractice claims to anesthesiologists. The development of safer~     anesthesia regimen for sedation are, therefore, needed. The establishment of safer~     anesthetics regimen for sedation is in direct relationship with the anesthesia patient~     safety foundation priorities. It addresses peri-anesthetic safety problems for healthy~     patient's. It can also be broadly applicable and easily implemented into daily clinical~     care. Ketamine has an established effect on analgesia but the effects of ketamine on~     ventilation have not been clearly defined. The investigators have demonstrated that the~     transcutaneous carbon dioxide monitor is accurate in detecting hypoventilation in patients~     undergoing deep sedation. Animal data suggest that when added to propofol in a sedation~     regimen, ketamine decreased hypoventilation when compared to propofol alone. It is unknown~     if ketamine added to a commonly used sedative agent (propofol) and fentanyl can decrease the~     incidence and severity of hypoventilation in patients undergoing deep sedation.~      The investigators hypothesize that patients receiving ketamine, propofol and fentanyl will~     develop less intraoperative hypoventilation than patients receiving propofol and fentanyl.~      The investigators also hypothesize that this effect will be even greater in patients with~     obstructive sleep apnea than patients without obstructive sleep apnea.~      Significance: Respiratory depression due to over sedation was identified twice as the major~     factor responsible for claims related to anesthesia. The high prevalence of obstructive~     sleep apnea combined with more complex procedures done in outpatient settings can increase~     physical risks to patients and liability cases to anesthesiologists. The main goal of this~     project is to establish the effect of ketamine in preventing respiratory depression to~     patients undergoing procedures under deep sedation using propofol and fentanyl.~      If the investigators can confirm our hypothesis, our findings can be valuable not only to~     anesthesiologist but also to other specialties (emergency medicine, gastroenterologists,~     cardiologists, radiologists) that frequently performed procedural sedation.~      The research questions is; does the addition of ketamine prevent hypoventilation during deep~     sedation using propofol and fentanyl?~      The hypotheses of this study: Ketamine will prevent hypoventilation during deep sedation~     cases.~   "
94126|NCT01825070|"~     Cherries have been show to possess the ability to reduce uric acid concentrations and~     inflammation. Tart Montmorency cherries possess a higher concentration of the plant~     compounds than other cherries and hence makes the expectation possible that Montmorency~     cherries will lower uric acid and inflammation.~   "
94127|NCT01825057|"~     General medical hospitals provide care for a disproportionate share of patients who abuse or~     are dependent upon substances. This group is among the most costly to treat and has the~     poorest medical and substance use outcomes. Motivational interviewing(MI) is a~     well-recognized, evidenced-based substance abuse treatment that has been adapted for use as~     a brief intervention in health care settings.MI is applicable to many health-related~     behavioral problems, and can be taught to a broad range of health care clinicians. However,~     it is unclear which implementation strategies will lead to the efficient and proficient~     uptake of MI in general medical settings, such as medical inpatient units.~      Primary care clinicians have multiple practice demands and time constraints. New practices~     have the greatest chance of being implemented if they are simple and compatible with~     existing workflows and systems. Two widely used strategies to bring specialized practices~     into use within general hospital settings are the see one, do one apprenticeship model of~     training and use of consultation-liaison (CL) services. See one, do one has been a modus~     operandi in medical education for centuries and relies upon a competency-based supervision~     training approach. While it has been empirically validated in the specialty addiction field,~     less controlled testing of this implementation strategy is available in general medical~     settings. The apprenticeship approach requires that appropriate patients and trainers are~     available with high flexibility for teaching and supervision; when applied to behavioral~     counseling approaches, this may be seen as incompatible with the medical role and time~     constraints of clinicians. In contrast, ordering MI through CL is a relatively simple,~     minimally burdensome process and highly compatible with the way clinicians secure other~     specialist services for their patients in the hospital.~      We propose to conduct a randomized controlled trial using mixed quantitative and qualitative~     methods to examine the effectiveness of three different strategies for integrating MI into~     the practice of healthcare providers working within Yale New Haven Hospital's internal~     medicine hospitalist service and other general medical inpatient units. Specifically, we~     will randomize 40 healthcare providers to one of three conditions: (1) a continuing medical~     education workshop that provides background and shows healthcare providers how to conduct~     MI (the control condition, called SEE ONE); (2) a see one, do one apprenticeship model~     involving workshop training plus live supervision of bedside practice (DO ONE); and (3)~     ordering MI from CL after learning about it in a workshop (ORDER ONE). Following the~     respective MI trainings, each healthcare provider will be assessed for the provision of MI~     to 40 study-eligible inpatients, recruited by the research team after admission to our~     general medical units.~   "
94138|NCT01824914|"~     Difficult tracheal intubation is a cause of severe patient damage and death. There is not a~     good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization~     of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a~     Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of~     the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to~     compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the~     role of videolaryngoscope in predicting difficult intubation.~   "
94247|NCT01823497|"~     The aim of this study is to examine the safety and effectiveness of 2 morphine delivery~     systems for post-surgical neonates. The investigators hypothesize that this study will be~     feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled~     Analgesia pump will receive less morphine and experience fewer side effects than neonates~     receiving morphine via continuous opioid infusion.~   "
94128|NCT01825044|"~     This is an open label study on the pharmacokinetics and safety of ciclosporin in patients~     with severe traumatic brain injury, who require intensive care unit admission and monitoring~     of intracranial pressure via a ventricular catheter. 20 patients will be screened, and~     subsequently enrolled after clinical stabilisation. Thereafter, patients will receive 2.5~     mg/kg bolus dose infusion of ciclosporin, followed by either 5 mg/kg/day or 10 mg/kg/day of~     ciclosporin as continuous infusion for 5 days+3 days monitoring at the intensive care unit.~     After an additional 30 days, a follow-up phone call will be made to the patient, or the~     patient's nursing staff, checking patient status and serious adverse events. The two dose~     levels will be investigated in 10 patients each, starting with the lower dose level for the~     first 10 patients. Patients will have samples of blood and cerebrospinal fluid drawn at~     pre-defined time points during the study for pharmacokinetic assessment and evaluation of~     biomarkers. Bedside monitoring with microdialysis and brain tissue oxygenation will be~     performed. The safety monitoring includes nephrotoxicity, hepatotoxicity, monitoring of~     intracranial pressure (ICP), infections monitoring and adverse events collection and~     reporting.~   "
94129|NCT01825031|"~     A randomised controlled trial to investigate three methods to reduce early mortality in~     adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART)~     with severe immuno-deficiency. The three methods are:~      (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral~     drugs from 3 classes~      (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12~     weeks~      (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.~   "
94130|NCT01825018|"~     Formative Research Phase (Months 1-6) The investigators will undertake qualitative formative~     studies to: (1) identify barriers to highly active antiretroviral therapy (HAART) and~     strategies currently used to engage PLH in care; (2) identify access points and ways to~     reach a diversity of PLH social networks; (3) gain an understanding of PLH views,~     motivations, barriers, and facilitators of care entry, maintenance, and adherence; (4)~     examine the structure and segments of the PLH community in St. Petersburg; and (5) elicit~     input from members of the PLH community and its stakeholders concerning the planned network~     recruitment, assessment, and intervention procedures and content. The investigators will~     refine protocols used in their intervention pilot study based on findings of the formative~     research phase.~      Main Trial Phase (Months 7-60)~      Overview of the main intervention outcome trial's experimental design. The main trial is a~     two-arm randomized outcome study. A total of 32 sociocentric social networks of PLH will be~     recruited by first identifying initial seeds—always PLH who are either out-of-care or~     treatment nonadherent—in multiple access points that were identified in the formative phase.~     The investigators will then enroll three rings of HIV+ friends outward beginning with each~     seed. Each sociocentric network is expected to consist of approximately 16 to 18 individuals~     (expected n=32x18=576 participants). This estimate is based on the size and density of~     participants' personal networks observed in our pilot studies. Each network member will be~     assessed at baseline using measures to be described shortly and will receive individual~     motivational counseling in care and adherence. This session will prime participants to an~     understanding about the availability, accessibility, and benefits of care. Members of the 16~     PLH networks randomized to the experimental condition will then receive the network~     intervention. Cadres of empirically identified influence leaders within each network will be~     identified, trained, and engaged to reinforce network member engagement and adherence. At 6-~     and 12-month followup points, assessment data will again be collected to determine~     intervention impact on the primary and secondary outcomes.~   "
94131|NCT01825005|"~     The main aim is to validate and improve the predictive model for survival and toxicity in~     patients with cervical cancer through multicentric prospective data collection. The data~     contain information on patient, tumor and treatment characteristics. For this study,~     additional health related QOL scores will be assessed using the EORTC Quality of Life~     Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a~     Decision Support System based on the predictive model validated in this study.~   "
94132|NCT01824992|"~     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for~     the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type~     infections and clinical negative conversion.~      285 patients with positive high risk HPV infection were randomized into interferon gel group~     and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in~     control group). The patients in treatment group received 1g recombinant human α-2b~     interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment~     was conducted in control group.~   "
94133|NCT01824979|"~     The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other~     commercially available masks for continuous positive airwary pressure (CPAP) therapy.~   "
94134|NCT01824966|"~     There has been much controversy surrounding the biologic behavior and prognosis of~     esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior~     of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs~     with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).~   "
94135|NCT01824953|"~     Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic~     gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination~     of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for~     detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis.~     The investigators aimed to uncover whether this combination method could predict the risk of~     gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the~     participants will be followed for an expected average of 3 years.~   "
94136|NCT01824940|"~     Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of~     their mortality and leads to long-term cognitive deficits, fewer years and poorer~     performance in school, lower adult economic productivity, and a higher risk that their own~     children will also be stunted, perpetuating the problem into future generations. Stunting~     begins antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age~     Z-score (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of~     young children can reduce stunting, though, at best, only by about one-third. Frequent~     diarrheal illness has also been implicated. However, the effect of diarrhea on permanent~     stunting is relatively small, maybe because children grow at catch-up rates between~     illness episodes.~      The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part~     premise:~        -  A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED).~          EED is a subclinical disorder of the small intestine, which is virtually ubiquitous~          among asymptomatic people living in low-income settings throughout the world. EED is~          characterized by increased permeability which facilitates microbial translocation into~          the systemic circulation and triggers chronic immune activation.~        -  The primary cause of EED is infant ingestion of fecal microbes due to living in~          conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).~   "
94139|NCT01824901|"~     This randomized phase I/II trial studies the side effects and best dose of fibroblast growth~     factor receptor (FGFR) inhibitor AZD4547 when given with docetaxel and to see how well it~     works in treating patients with recurrent non-small cell lung cancer. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. FGFR inhibitor AZD4547 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is~     not yet known whether docetaxel and FGFR inhibitor AZD4547 are more effective when given~     together or separately.~   "
94140|NCT01824888|"~     JUC is a commercially available wound care spray. It is evaluated for the efficacy when~     using as a hygienic hand rub following the protocol described in the European standard EN~     1500:1997 Chemical disinfectants and antiseptics - Hygienic handrub - Test method and~     requirement (phase 2/step 2). A crossover study to compare the JUC solution with 60% (v/v)~     propan-2-ol by using Escherichia coli K12 NCTC strain 10538 as test organism.~   "
94141|NCT01824875|"~     This randomized phase II trial studies how well giving temozolomide with or without~     capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors.~     Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. It is not yet known whether temozolomide is more~     effective with or without capecitabine in treating patients with advanced pancreatic~     neuroendocrine tumors.~   "
94142|NCT01824862|"~     Clinically significant macular edema (CSME) is a thickening of the macula associated with~     the risk of visual loss, which increases its centre is involved. Functional evaluation of~     the macula relies on best corrected visual acuity; however, neural dysfunction in diabetic~     eyes appears before retinal thickening and visual loss. Retinal sensitivity decreases in~     eyes with CSME, but it is unknown whether it differs between eyes with and without centre~     thickening.~      Aim: To compare the reduction of foveal sensitivity in eyes with CSME, with and without~     centre thickening.~   "
94143|NCT01824849|"~     Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss~     than other operations performed for bilateral vocal fold paralysis (BVFP). However,~     objective evidence for such conclusion is lacking. There is no study comparing swallowing~     and voice after total and partial arytenoidectomy.~   "
94144|NCT01824836|"~     E1Z11 is a study to determine whether certain genetic information can predict which breast~     cancer patients will discontinue treatment with AIs due to the development of~     musculoskeletal symptoms (MSS). Women with stage 1-111 breast cancer who are prescribed the~     aromatase inhibitor anastrozole as treatment may join.~   "
94145|NCT01824823|"~     This randomized phase II trial studies how well giving afatinib after chemoradiation and~     surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and~     neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
94146|NCT01824810|"~     This pilot study is being conducted to provide proof of concept for three recently developed~     needling treatments, in the treatment of whiplash associated disorder type 2 (WAD-II). The~     investigators aim to show that these techniques should be considered as regular, effective~     options for people suffering from WAD-II. These techniques are Intramuscular stimulation~     (IMS), neural prolotherapy (NPT), and myoActivation (mA).~      Additionally, the investigators plan to begin profiling responders and non-responders in an~     effort to identify which treatment is likely to work best for different people. In the~     future, this may help to expedite treatment for WAD-II, helping patients get the most~     appropriate treatment, more quickly.~      The investigators expect to show that all three treatments are significantly better than a~     placebo treatment, and to collect information on what makes each technique more or less~     likely to work for individual cases.~   "
94147|NCT01824797|"~     The purpose and objective of this study is to determine the changes in bone metabolism after~     bariatric surgery in postmenopausal women.~      This is a prospective cohort study that will enroll up to 40 postmenopausal female subjects~     with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery.~     The study team will enroll subjects that are already being scheduled for either sleeve~     gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity,~     and the bone mineral density will be measured in all subjects preoperatively and 12 months~     postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry~     (DEXA) scans.~      The primary endpoints are change in osteoclast activity as measured by C-terminal~     telopeptide of type I collagen and change in bone density as measured by DEXA scan. These~     are continuous variable and given the small sample size the investigators will use a~     nonparametric Wilcoxon rank-sum test to compare the difference in one year change in these~     variables. There is a slight risk of loss of confidentiality. Every effort will be made to~     protect all PHI. There is also the risk of increased exposure to radiation from the DEXA~     scans performed twice with each subjects participating in the study.~   "
94148|NCT01823809|"~     The purpose of the study is to assess the diagnostic accuracy of a combined use of~     non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress~     cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and~     with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to~     invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.~   "
94149|NCT01823796|"~     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with~     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms:~     fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological~     disorders. The prevalence has been reported to be between 2 and 5%.~      The hypothesis of this study is that women with fibromyalgia present high risk of falls and~     balance disorders compared with healthy women. The objective of this study was to~     investigate wether gait pattern changes in single and dual task conditions were associated~     with the risk of falling in women with fibromyalgia.~   "
94248|NCT01823484|"~     Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and~     decrease the quantity of heparin during continuous renal replacement therapy in critically~     ill.~   "
94150|NCT01823783|"~     Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular~     dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein~     dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at~     the stage of clinical assays with very promising results. Nevertheless, they will not allow~     a complete cure of DMD patients and they will concern only specific types of mutations. It~     is therefore crucial to develop other therapeutic strategies related to the natural history~     of the disease and targeted not on the dystrophin itself, but on the consequences of its~     absence.~      Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis,~     particularly via the ryanodine recepteur (RyR1).~      Our study focus on the relationship between endomysial fibrosis, abnormal inflammation~     response and calcium homeostasis dysfunction which are not entirely established in DMD.~      The identification of the biological mechanisms that play a role in the severity of the~     phenotype, particularly endomysial fibrosis, should allow the development of targeted~     pharmacotherapy as a complementary strategy for the future treatment of DMD.~   "
94151|NCT01823770|"~     Several studies report association between restless legs syndrome (RLS), HTA and~     cardiovascular diseases .~      The mechanisms involved in this relationship remained unknown, but several evidences favor~     the role of periodic limb movements in sleep (PLMS), patterns frequently associated with~     RLS. Sympathetic overactivity is associated with PLMS with increased pulse rate and blood~     pressure coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations~     could contribute to the risk of high blood pressure, heart disease, and stroke in patients~     with RLS, especially in the elderly. Several studies already reported that dopaminergic~     agonists reduce the severity of RLS and the PLMS index.~      Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic~     dysfunctions in patients with RLS? Nocturnal BP (blood pressure) decline has major clinical~     implications, and the loss of normal reduction in BP during sleep is associated with high~     risk of cardiovascular morbidity and mortality.~      The main aim of this study was to evaluate the impact of rotigotine patch treatment on~     validated cardiovascular risk factors ambulatory BP during night, day and night-to-day~     ratio, and endothelial function in patients with idiopathic RLS compared to placebo.~   "
94152|NCT01823757|"~     This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100~     patients will be selected into this controlled study.The hypothesis are:~        1. After patients receive pharmaceutical care, their drug related problems will be~          decreased.~        2. After patients received pharmaceutical care, their self-reported medical expenditure~          will be decreased.~   "
94153|NCT01823744|"~     The purpose of this trial is to better define how individuals with different genetic~     make-ups will require different interventions to improve their methylation potential and~     nutrient status.~   "
94154|NCT01823731|"~     objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective~     description of perioperative tumor burden and surgical approaches in the management of~     ovarian cancer, tubal cancer, and primary peritoneal cancer~   "
94155|NCT01823718|"~     Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow~     transplantation, organ transplantation or patient immunodeficient.~      They will receive one to three injections of allogenic CTL specific EBV.~      The purpose of this study is to ensure that these injections can not cause a GVH and to~     study what the side effects are and to see whether this therapy might help patients with~     Lymphoma.~      Immunological monitoring will also be studied.~   "
94156|NCT01823705|"~     The purpose of this feasibility study is to provide safety data on the implantable Exilis~     gastric electrical stimulation (GES) system, to individually adjust stimulation parameters~     to levels that are comfortable for implanted subjects during chronic daily treatment, and to~     collect data on acute gastrointestinal function and food intake responses to GES during~     in-clinic testing.~   "
94157|NCT01823692|"~     The purpose of this study is to evaluate whether ultrasonography guidance compare with the~     simple radiography aids in determining the adequacy of distal radius fracture reduction.~   "
94158|NCT01823679|"~     This phase II trial studies how well capecitabine works in treating patients with advanced~     or recurrent squamous cell carcinoma of the skin. Drugs used in chemotherapy, such as~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing.~   "
94159|NCT01823666|"~     Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The~     investigators assume that some psychological and imaging risks may predict the conversion.~     In the current longitudinal study, psychological and imaging data of people with MCI will be~     obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be~     found in comparison with controls.~   "
94160|NCT01823653|"~     The purpose of this study is to assess the safety and efficacy of treatment with the~     Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue~     (SAT) of the thighs.~   "
94161|NCT01823640|"~     Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre. In~     addition, to facilitate future clinical trials, we want to determine optimal read-out~     parameters and read-out time points for experimental HRV infection in healthy volunteers.~     Furthermore, we want to analyze to what extent HRV can cause systemic immune effects, and we~     want to test if subjects with antibodies against HRV can be re-infected with the same virus,~     and if the presence of HRV antibodies influences the local clinical and immunological~     response upon infection. Additionally, to gain insight in the immune modulating properties~     of HRV, we want to investigate the immunological response to a HRV re-infection within one~     week to determine if there are mechanisms that provide immediate protection against~     re-infection. This facilitates a cross-over design of future pharmacological~     intervention-trials. Furthermore, we want to investigate the capacity of HRV infection to~     modulate the systemic immune response by analyzing the response of leukocytes ex vivo~     stimulated with different stimuli. Moreover, we want to evaluate the effects of HRV-16~     infection on the host transcriptome and metabolome. Finally, The influence of HRV-16~     infection on nasal and gut microbiota will be assessed.~   "
94871|NCT01815346|"~     The goal of this clinical research study is to compare the level of effectiveness for 2~     acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers~     also want to study how patients may respond to acupuncture treatments, and how the~     treatments may affect quality of life, hand function, balance, and the use of drugs for~     neuropathy pain.~   "
94162|NCT01823627|"~     Purpose: Patients with mental health disorders have a reduced life expectancy, compared to~     the general population. The shorter life expectancy is caused by natural and unnatural~     death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle,~     than the general population, characterized by e.g. lack of exercise and smoking.~      Hypothesis~      Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients~     There is a higher prevalence of COPD in psychiatric inpatients compared to the general~     population Screening of patients with one respiratory symptom and a smoking history, has the~     same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking~     history~      Method:~      80 psychiatric inpatients will undergo spirometry with reversibility test and COPD~     Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and~     smoking will be taken into account.~   "
94163|NCT01823614|"~     To date, all work related to the study of HIV tropism, was performed on HIV B and C~     subtypes. In the studied samples, HIV variants of subtype A were virtually absent. However,~     the existence has been shown previously of some differences in the nucleotide sequences in~     the V3 loop of env region of subtype A from other subtypes of virus. In the Russian~     Federation the subtype A of HIV-1 is predominant, and, according to some estimates, accounts~     for about 89% of all newly diagnosed cases of HIV infection. Thus, it seems interesting and~     effective to study the characteristics of HIV-1 subtype A, associated with the tropism, in~     the Russian Federation.~      The primary objective is determination of the prevalence of R5 (chemokine receptor 5), X4~     (chemokine receptor 4), and R5X4-tropic variants of HIV in HIV-infected population in~     Russia, and analysis of the possible features of tropism of viruses belonging to subtype A.~   "
94164|NCT01823601|"~     The aim of present study is to evaluate whether a program of behavioral and cognitive~     procedures for emotional control, and assertive training, produces well-being and~     improvement in quality of life of healthy volunteers.~   "
94165|NCT01824784|"~     To determine optimal cut-off value for TopQ cut-off.~   "
94166|NCT01824771|"~     Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively~     and replace renal function partly. It is widely used in intensive care units (ICUs),~     especially for patients with acute kidney injury/failure in an unstable hemodynamic status.~     Lactate is a molecule smaller than glucose, which can pass through filtration membrane~     freely in CVVH. Therefore, the blood lactate concentrations would no longer reflect tissue~     oxygenation status in patients with unstable hemodynamic status. However, there is no~     prospective study evaluated the effect of CVVH on lactate removal in critically ill~     patients. The influence of different dose of CVVH on lactate elimination is not clear in~     patients with different level of serum lactate. Our study aimed to find out how the dose of~     CVVH effects on lactate clearance, and then re-estimate the prognostic value of lactate in~     critically ill patients with CVVH.~   "
94167|NCT01824758|"~     90 American society of anesthesiology (ASA) physical status I and II patients undergoing~     general anesthesia for elective surgery will be included in the study. Patients will be~     randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine~     (1.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After~     intravenous induction with propofol, adequate muscle relaxation for intubation will be~     received by 0.5 mg/kg rocuronium.~   "
94168|NCT01824745|"~     This randomized pilot clinical trial studies survivorship care planning in improving the~     quality of life in breast cancer survivors. Survivorship care planning may reduce stress and~     improve the well-being and quality of life of cancer survivors.~   "
94169|NCT01824732|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in December 2012.~      The purpose of this study is to make a event monitoring to see whether Tanreqing injection~     is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing~     injection in hospitals in China.~   "
94170|NCT01824719|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in January 2013.~      The purpose of this study is to make a event monitoring to see whether Reduning injection is~     safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection~     in hospitals in China.~   "
94171|NCT01824706|"~     A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of~     Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™~      The patients will be included as soon as they are ilplanted and follow-up for 2 years. It is~     observationnal so no specific exam is planned.~      The explantation rate will be measured, that is to say the number of patients whose~     prosthesis will be removed (with or without any relationship with the implant or the~     procedure).~   "
94172|NCT01824693|"~     This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and~     melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant~     works in treating younger patients with juvenile myelomonocytic leukemia. Giving~     chemotherapy before a donor hematopoietic transplant helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient, they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not~     yet known whether giving busulfan, cyclophosphamide, and melphalan or busulfan and~     fludarabine phosphate before a donor stem cell transplant is more effective in treating~     juvenile myelomonocytic leukemia.~   "
94173|NCT01824680|"~     The primary purpose of this protocol is to assess the hormonal regulation of satiety by an~     intense exercise before and after a 3 month physical activity program. Hormones assessed~     are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.~      It is well known that in overweight adults and children also, an intense physical exercise~     diminish the food intake relatively to the total energy expenditure and this effect is~     persistent after a 6 weeks physical activity program.~      Our hypothesis are: a diminution of food intake after the intense physical exercise and a~     persistent diminution of food intake after the 3 month physical activity program, an~     augmentation of levels of GLP-1 and PYY during the intense exercise before and after the~     physical activity program, a diminution of the level of GLP-1 and leptin before and after~     the physical activity program~   "
94907|NCT01814852|"~     This is a prospective, randomized, double-blind clinical study for assessing the safety and~     efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.~   "
94174|NCT01824667|"~     The aim of the study is to evaluate the effects of a new food supplement which is currently~     available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g.~     bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms~     but are otherwise healthy.~      About 400 volunteers will take part in this study, which will last 6 weeks (to include 4~     weeks treatment and 2 weeks follow up period).~      Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and~     flatulence), in the absence of diseases, are commonly associated with food or drug intake or~     with alterations of bowel habit and vary between individuals in frequency and severity.~      Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously~     in trials with healthy younger and older adults and we have observed a trend towards~     reducing abdominal bloating. However, the investigators have not tested B-GOS in healthy~     adults who often experience these symptoms and this is what we will investigate now.~   "
94175|NCT01824654|"~     An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing~     population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG)~     insertion is frequently indicated in patients with intermediate and high-operative risk.~     Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic~     criteria. SG are inserted in the catheterization laboratory under digital substraction~     angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue~     differentiation is available during the intervention and important information are lacking~     such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team~     has recently patented a software allowing the extraction of the AAA (lumen and thrombus)~     from pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have~     integrated this technology to the Siemens workstation in the catheterization laboratory. The~     investigators can now import the aortic lumen and thrombus meshes segmented from~     pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to~     enhance visualization of soft tissue during EVAR.~      Our preliminary results are encouraging in terms of feasibility and visualization. However,~     the delivery device of the SG and the guidewire used during the intervention are stiff and~     induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of~     rigid registration. The investigators propose to improve registration accuracy by~     implementing an elastic deformation of aortic lumen and wall based on the segmentation of~     endovascular devices (delivery device, guidewires and catheters) inserted during the~     procedure and by biomechanical modeling.~   "
94176|NCT01824641|"~     The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial~     Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a~     planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction~     (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration~     using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to~     conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index~     of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus~     aspiration compared to conventional PCI group.~   "
94177|NCT01824628|"~     This is a unicentric, two cohorts, observational transversal study.~      The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects~     receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.~   "
94178|NCT01824615|"~     Patients with early and advanced stages of epithelial ovarian cancer are treated with~     postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive~     surgery. For ovarian cancer patients with recurrence, salvage chemotherapy with or without~     secondary cytoreductive surgery are recommended. The recommendation for specific primary~     adjuvant or salvage chemotherapy is cyclophosphamide or paclitaxel plus platinum regimens.~     Despite the high objective response rate associated with primary chemotherapy in ovarian~     cancer, the majority of patients will eventually experience disease recurrence and be~     potential candidates for a second-line treatment approach.~      Ovarian clear cell adenocarcinoma (OCCA) is recognized as a distinct histological type of~     cancer in the WHO-classification of ovarian tumors. OCCA is thought to arise from~     endometriosis and most patients present with the disease at early stages (International~     Federation of Gynecology and Obstetrics (FIGO) stages I and II). The incidence of OCCA among~     epithelial ovarian cancers is estimated to be less than 5-10%. However, OCCA occurs more~     frequent in Japan and Taiwan (around 10-15%). Unfortunately, OCCA is usually more resistant~     to systemic chemotherapy than other types and has a poorer prognosis.~      Sunitinib is a small molecule with anti-tumor properties pharmacologically mediated through~     inhibition of multiple receptor tyrosine kinase (RTKs), which are important regulators of~     tumor cell growth, angiogenesis, and metastasis. Due to its multi-targeted profile, the~     pharmacological activity of sunitinib is likely mediated by inhibition of multiple RTK~     targets and multiple pathways. c-KIT has been implicated in mastocytosis/mast cell leukemia,~     germ cell cancers, small-cell lung cancer, GISTs, AML, neuroblastoma, melanoma, and ovarian~     and breast carcinoma. In addition, sunitinib has demonstrated a higher response rate than~     that reported for anti- VEGF antibody treatment in patients with renal cell carcinoma (RCC).~     A few clinical case reports indicated sunitinib is effective in treating recurrent ovarian~     clear cell adenocarcinoma (OCCA) which is almost resistant to second line chemotherapy.~      So we would like to conduct this Phase II Sunitinib clinical trial in recurrent / persistent~     ovarian clear cell cancer patients.~   "
94179|NCT01824602|"~     The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine~     acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with~     placebo, as therapy in patients with acute mania. The secondary objectives of this study~     were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093)~     administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the~     duration to onset of action in the different dose groups, and c) monitor the appearance of~     depressive symptoms.~   "
94180|NCT01824589|"~     The purpose of this study is to demonstrate proof of clinical concept that application of~     the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion~     Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head~     injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).~   "
94181|NCT01824576|"~     The purpose of the study is to evaluate the physiological response to application of the~     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.~     The study will evaluate the physiological response to intrathoracic pressure regulation~     (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who~     are on ventilatory support.~   "
94246|NCT01823510|"~     The purpose of this study is to determine whether treatment with ticagrelor + aspirin is~     more effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes.~     Both treatments will be given (separately) to all subjects as a one-time loading dose (i.e.~     higher than a normal daily dose), followed by daily dose for the next 5 to 7 days.~     Effectiveness of treatment will be measured with specialized blood tests before the loading~     dose, at two time-points after the loading dose, and once after the last daily dose.~   "
94182|NCT01824563|"~     The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala~     electrode. As a point of interest the investigators would like to evaluate the benefit to~     patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode.~     The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a~     variety of contemporary surgical techniques that have been shown to enable easy insertion~     and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and~     Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the~     HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal~     trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition ,~     the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op~     clinical results in the premarketing study that is now in the final stage.~   "
94183|NCT01824550|"~     The objective of this study is to determine the effect of home-based, aerobic exercise~     training on subclinical atherosclerosis and mobility disability in persons with Multiple~     Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both~     subclinical atherosclerosis and mobility disability.~   "
94184|NCT01824537|"~     Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is~     capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina,~     and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have~     been proven to be highly effective in preventing the acquisition of HPV infection and the~     genital precancerous lesions caused by it. However, we do not know yet if a previously~     infected individual, once vaccinated, would be less infective to her or his sexual partner.~     We plan to conduct a study, called Transmission Reduction And Prevention with HPV~     vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active~     couples (total of 1000 individuals) in university student health clinics in Montreal (age~     18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial.~     Study participants will be followed up to 12 months. Behavioural and biological data will be~     collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment.~     The results of this trial will be invaluable in informing policies regarding vaccination of~     women and men.~   "
94185|NCT01824524|"~     The purpose of this study is to assess the single dose pharmacokinetic profile (explores~     what a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone~     in chinese participants with cancer (abnormal tissue that grows and spreads in the body) who~     are not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage~     of drug over time and higher doses of a drug are needed to get desired effect).~   "
94186|NCT01824511|"~     The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes~     rewarding events become less rewarding. The current study will test if this is true in~     humans. If we find tobacco abstinence does make rewards less rewarding, this would suggest~     new symptoms to add to official descriptions of nicotine withdrawal. It would also suggest~     we need to develop new behavioral and pharmacological interventions to correct this problem.~     If stopping smoking does not make rewards less rewarding, this would suggest this animal~     model does not apply to the human condition and we need to continue to search for an animal~     model of tobacco withdrawal that is relevant to smokers stopping smoking.~   "
94187|NCT01824498|"~     The primary objective of this investigation is to determine whether diets designed to~     increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid~     enrichment), will favorably affect sex hormone distribution in women in a direction~     associated with reduced risk of sex hormone-mediated cancer development. Specifically, we~     hypothesize that an increased concentration of circulating n3 fatty acids will reduce the~     biochemical markers associated with increased risk for developing certain sex hormone~     mediated cancers such as breast cancer~   "
94188|NCT01824485|"~     Viscosupplementation by intra-articular injection of hyaluronate products has recently~     gained popularity as a treatment modality of gonarthritis.There is not, however, a consensus~     on the best method.Our objective is to evaluate what is the best dosage of~     viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of~     triamcinolone hexacetonide. One hundred and four patients with knee osteoarthritis (KOA)~     were divides into 2 groups of 52 patients each to receive either a single application of 3~     ampoules of OSTEONIL® + 1ml of Hexacetonide of triamcinolone or three applications of 1~     ampoule of OSTEONIL®, one per week for three weeks + 1ml of Hexacetonide of triamcinolone~     only in the first injection. Primary endpoint was clinical results expressed by Visual~     Analogic Scale of pain (VAS), Western Ontario and Mcmaster Universities (WOMAC) and Lequesne~     questionaires at one, three, six and 12 months after the procedure~   "
94189|NCT01824472|"~     Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in~     some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea.~     The purpose of this study is to find out what type of insomnia symptoms are caused by~     obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea~     treatment with continuous positive airway pressure (also known as CPAP) and if additional~     treatment with cognitive-behavioral therapy for insomnia is beneficial.~   "
94190|NCT01824459|"~     The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin~     vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Diffuse Gastric~     Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.~   "
94191|NCT01824446|"~     To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the~     study drug. Further, the study will determine how much of the study drug gets into the~     bloodstream and how long it takes the body to get rid of it when given as a single dose to~     healthy male subjects.~   "
94206|NCT01824251|"~     Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed~     based on the European Federation of Neurological Societies/ Peripheral. Nerve Society~     Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion~     criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive~     days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory~     Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
94192|NCT01824433|"~     Women are more prone to depression at certain points of the life cycle, although the~     etiologic and therapeutic implications remain largely unknown1,2. It is reported that pre-~     and postmenopausal women have a significant difference in response to some antidepressants,~     within a large clinical trial data set3, 4. A growing number of researches indicate that a~     woman's hormonal status may influence response to different forms of antidepressant~     medication. Specifically, younger women appeared to respond better to monoamine oxidase~     inhibitors (MAOIs) and selective serotonin reuptake inhibitor (SSRIs), whereas men and older~     women have tended to have relatively better responses to tricyclic antidepressants (TCAs)~     1-5. One difference between these classes of antidepressants is that the SSRIs are strongly~     serotoninergic, whereas TCAs have predominantly noradrenergic effects. One pooled analysis 6~     suggests that older women (age ≥ 50) tend to respond poorer to SSRI, while this phenomenen~     was not observed with venlafaxine.~      The antidepressive mechanism of venlafaxine that has both noradrenergic and serotonergic~     effects is superior to SSRIs. As a noradrenergic and serotonergic antidepressant,~     venlafaxinee has been demonstrated of significant advantages in response and remission rates~     compared with various SSRIs. As mentioned above, older women tend to have relatively better~     responses to TCAs which is predominantly noradrenergic antidepressant. Postmenopausal women~     with depression also would be predicted to respond better to an SSRI if administered along~     with hormone replacement therapy 6. This could be critical to understanding age difference~     in antidepressant responses across the life cycle because circulating estrogen levels may~     modulate central serotoninergic pathways. Therefore, it is presumed that antidepressants~     which enhance both serotonergic and noradrenergic neurotransmission, as venlafaxine, may be~     more effective than SSRIs for postmenopausal women with major depressive disorder.~   "
94193|NCT01824420|"~     To investigate if oxybutynin ER adding on antimuscarinics is more effective than~     mono-antimuscarinic treatment for patients with refractory OAB~   "
94194|NCT01824407|"~     The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as~     the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of~     diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act~     on the cells in your body to generate proteins that may lead to wound closure. The~     dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore~     its use in this study is investigational.~      The purpose of the study is to evaluate the ability of the dermaPACE® device to help~     diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be~     compared to an inactive look-alike device (called a Sham) in this study. The sham device~     will not provide any treatment to your diabetic foot ulcer.~   "
94195|NCT01824394|"~     To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with~     THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory~     symptomatic paroxysmal atrial fibrillation (PAF).~   "
94196|NCT01824381|"~     The purpose of this study is to analyze the security application of the amniotic membrane in~     extensive wounds in the granulation phase.~   "
94197|NCT01824368|"~     The purpose of this study is to evaluate the safety of extracorporeal photopheresis in~     patients with long-standing liver transplantation subjected to a progressive reduction of~     immunosuppression by complications arising from its use.~   "
94198|NCT01824355|"~     The purpose of this study was to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
94199|NCT01824342|"~     This is a multi-national, multi-center, open-label, single-arm extension study for the~     prolongation of bone metastasis-free survival in men with hormone-refractory (androgen~     independent) prostate cancer. Patients currently participating in the phase 3 study 20050147~     (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is~     determined in the 20050147 study. The primary endpoint of the 20050147 study is bone~     metastases-free survival determined by the time to first occurrence of bone metastases~     (either symptomatic or asymptomatic) or death from any cause. Participants will receive~     open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they~     developed a bone metastasis or for up to 3 years, whichever comes first.~   "
94200|NCT01824329|"~     Bladder cancer is the 4th most common cancer amongst men. If bladder cancer invades the~     muscle of the bladder or fails local treatments, surgical removal of the bladder~     (cystectomy) with creation of a new bladder from intestine is required. However, standard~     cystectomy affects urinary function and sexual function. The investigators are evaluating~     two modifications to cystectomy to determine to what extent they preserve urinary and sexual~     function.~   "
94201|NCT01824316|"~     Investigate differences in practice patterns in providers who may care for pregnant women~     with asthma exacerbations. The investigators believe that practitioners of different~     specialties will practice differently.~   "
94202|NCT01824303|"~     The purposes of the study is to determine if LiRIS®, an investigational drug-delivery~     system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any~     change in IC symptoms following LiRIS administration.~   "
94203|NCT01824290|"~     The main purpose of this study is to evaluate the safety and efficacy of tadalafil in~     pediatric participants with pulmonary arterial hypertension. Participants will receive study~     treatment for 6 months in the double-blind period (Period 1), and then will be eligible to~     enroll into an open-label 2 year extension period (Period 2) during which participants will~     receive tadalafil.~   "
94204|NCT01824277|"~     The Canadian Diabetes Association recommends optimizing glycemic control to achieve a~     glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these~     recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of~     suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients~     experience a higher rate of post-operative complications and significantly worse short-term~     and long-term post-operative survival. Therefore, it is recommended that attempts should be~     made to improve glycemic control while patients wait for their elective surgery. However, at~     present processes of care that facilitate pre-operative glycemic control optimization do not~     exist in Canada.~      The objective of this project is to determine the feasibility and effectiveness of a~     comprehensive community-based pre-operative diabetes optimization program for patients~     awaiting elective cardiac surgery.~   "
94205|NCT01824264|"~     The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of~     LIK066 to support dose selection for phase 3.~   "
94207|NCT01824238|"~     This study will evaluate the effects of anacetrapib (MK-0859) on low-density~     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with~     heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying~     therapy.~   "
94208|NCT01824225|"~     Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial~     monthly intravitreal aflibercept for the Japanese age related macular degeneration.~   "
94209|NCT01824212|"~     Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on~     standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is~     recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac~     arrest during the emergency call the survival of the patient improves. Accurate emergency~     medical service response is activated promptly and bystander will receive cardiopulmonary~     resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR~     instructions will save thousands of lives each year.~      If the ECG could be recorded by the mobile phone, transmitted during the emergency call to~     the dispatch centre and analysed there with the software of a semi-automated external~     defibrillator(AED), the recognition of cardiac arrest could be more accurate.~      The aim of this study is to examine, if AED, with minimal size electrodes within an area of~     a mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with~     the best prognosis in OHCA.~   "
94210|NCT01824199|"~     If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid~     secretion in patients taking once a day omeprazole.~   "
94211|NCT01824186|"~     This study aims to evaluate post-operative pain in single-incision laparoscopic~     cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators~     hypothesize that SILC is non-inferior in post-operative pain.~   "
94212|NCT01824173|"~     Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle,~     a condition that can impair muscle metabolism. The proposed research will discover~     mechanisms responsible for decreased content in mitochondrial proteins as well as in protein~     β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese~     individuals. This research will further examine the effectiveness of interventions, such as~     increased plasma amino acid availability and exercise, to increase the rate of production of~     mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals.~     The findings will help to develop appropriate interventions to improve muscle ATP turnover~     and metabolism in obese people.~   "
94213|NCT01824160|"~     The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in~     the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the~     right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of~     their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing~     such tears in the process of preparing the conduit to accept the new valve. In order to~     implant such a valve, the connection between the right ventricle and the pulmonary arteries~     often needs to be enlarged. High pressure balloons may be needed and these balloons can~     sometimes cause tears in or even rupture of the connecting conduit. Such tears can allow~     blood to flow into the chest and rarely this can lead to a life-threatening emergency.~     Experience suggests that such tears can be closed by implanting into the conduit a metallic~     stent with an outer covering, rebuilding the wall and allowing continuation of the valve~     implant.~   "
94214|NCT01824147|"~     It is the aim of the present study to assess the prevalence of ASS-Nonresponse following~     cardiac surgery using the Multiple Electrode Aggregometry (MEA).~   "
94215|NCT01824134|"~     The investigators are testing two over the counter aloe veras on irradiated breast tissue.~   "
94216|NCT01824121|"~     There is evidence suggesting that stem cells harvested from the bone marrow and transplanted~     into the brain may be effective in slowing down the progression of parkinsonism. Mesenchymal~     stem cells are able to produce growth factors that provide support to diseased nervous~     cells.~      In this study mesenchymal stem cells will be harvested from the bone marrow, cultivated in a~     test tube so that they multiply and then infused into the arteries that supply blood to the~     brain in 20 patients suffering from a rare form of parkinsonism, Progressive Supranuclear~     Palsy. Each patient will undergo two infusions, one with the stem cells and one without, at~     an interval of 6 months. The sequence of the two infusions will be assigned randomly;~     patients and assessors will not know the sequence (double-blind). Patients will be~     followed-up for up to 1 year after the last infusion, with regular assessments to assess~     safety, efficacy on motor and cognitive functions, and effects on the brain by neuroimaging~     techniques.~      The study has a preliminary phase with 5 patients all given stem cell therapy alone,~     designed to assess safety~   "
94217|NCT01824108|"~     Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as~     Wallis interspinous implants have also been successfully used in disc degenerative diseases.~     However, the superiority of a discectomy with Wallis in comparison to a discectomy alone for~     primary lumbar disc herniation has yet to be determined.The aim of our study is to~     investigate whether lumbar discectomy combined with the Wallis device provides better~     radiographic and clinical short-term outcome than posterior lumbar discectomy alone.~   "
94218|NCT01824095|"~     The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term~     (6 week) and long-term (6 month) effect of chiropractic care combined with a specific~     nutritional supplement regimen to chiropractic care with a placebo supplement for patients~     with ankle sprains, in terms of improvement in physical function and pain.~   "
94219|NCT01824082|"~     When a limb is traumatically severed, pain perceived in the part of the body that no longer~     exists often develops. This is called phantom limb pain, and is different from stump~     pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom~     pain resolves in only 16% of people, with the rest experiencing this pain for the remainder~     of the lives. There is currently no reliable treatment for phantom limb pain.~      The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut—as~     happens with a traumatic amputation—changes occur in the brain and spinal cord that actually~     worsen with increasing phantom pain. These abnormal changes may often be corrected by~     putting local anesthetic—termed a peripheral nerve block—on the injured nerve, keeping any~     bad signals from reaching the brain, with resolution of the phantom limb pain. However,~     when the nerve block ends after a few hours, the phantom pain returns. But, this~     demonstrates that the brain abnormalities—and phantom pain—that occur with an amputation may~     be dependent upon the bad signals being sent from the injured nerve(s), suggesting that a~     very long peripheral nerve block—lasting many days rather than hours—may permanently reverse~     the abnormal changes in the brain, and provide lasting relief from phantom pain.~      Until recently, extending a peripheral nerve block beyond 16 hours was unrealistic. However,~     a treatment option called a continuous peripheral nerve block is now available. This~     technique involves the placement of a tiny tube—smaller than a piece of spaghetti—through~     the skin and next to the nerves supplying the amputated limb. The tiny tube may be placed~     with minimal discomfort in about 15 minutes. Numbing medicine called local anesthetic is~     then infused through the tube, blocking any signals that the injured nerve sends to the~     spinal cord and brain. Using a small, portable infusion pump, this prolonged nerve block may~     be provided in individuals' own homes.~      The ultimate objective of the proposed research study is to determine if a 6-day continuous~     peripheral nerve block provided at home is an effective treatment for persistent phantom~     limb pain following a traumatic limb amputation. The primary hypothesis (what the~     researchers predict) is that phantom limb pain intensity will be significantly decreased 4~     weeks following treatment with a 6-day continuous peripheral nerve block.~   "
94220|NCT01824069|"~     It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells~     derived from lipoaspirate for treating various pathologies fistula. With this project we~     will address a study population with critical ischemia of lower limbs without possibility of~     revascularization, either by technical criteria (no intervention possible to compensate for~     the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for~     the type of intervention required). It will almost always elderly patients with multiple~     comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with~     very high probability of major amputation in the short term or immediate.~      Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded ex vivo, are capable~     of promoting angiogenesis de novo to improve critical limb ischemia lower~     nonrevascularizable a safe manner~   "
94221|NCT01824056|"~     The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET~     to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders,~     including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive~     supranuclear palsy (PSP).~   "
94222|NCT01824043|"~     Primary Objective:~      To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis~     (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic~     retinopathy.~      The primary endpoint for the study will be the mean change in best-corrected visual acuity~     (BCVA) from baseline to the mean level at Month 3.~      Secondary Objectives:~        1. To assess any differences in mean change in BCVA over time;~        2. To assess differences in vitreous transparency (amount of hemorrhage) with fundus~          angiography exam;~        3. To assess any differences in retinopathy severity level according to the Early~          Treatment Diabetic Retinopathy Study;~        4. To correlate the visual outcomes with serum glucose levels.~   "
94223|NCT01824030|"~     Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL)~     is a major clinical issue. Intravascular techniques (assessing either the anatomy or the~     functional effect of coronary stenoses) are routinely used to better characterize coronary~     lesions. Among these,fractional flow reserve (FFR) provides validated functional insights~     while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both~     techniques may be applied to guide decisions regarding the opportunity to revascularize~     patients with AICL and to optimize the result of percutaneous coronary intervention (PCI).~     We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the~     percutaneous management of patients with AICL.~   "
94224|NCT01824017|"~     The current proposal extends work done in mouse models evaluating the consistency of~     measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for~     validating biomarkers. We will also proceed to estimate the effect size of a potential~     correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and~     triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort~     of patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month~     period..~   "
94225|NCT01824004|"~     This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant~     treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.~   "
94226|NCT01823991|"~     The purpose of this study is to examine the safety and influence of an intervention~     (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on~     cognitive performance in breast cancer survivors following chemotherapy. The investigators'~     goal is to treat or lessen the late effects of cancer treatment. The supplement to be used~     will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins~     from blueberries (BB) and (2) n-3 fatty acids - Lovaza.~   "
94227|NCT01823978|"~     This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and~     preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in~     patients with metastatic castrate resistant prostate cancer.~   "
94228|NCT01823965|"~     In the prospective monocentric open label trial patients with diabetic macular edema will be~     treated with intravitreal injections of ranibizumab given for 3 months then with laser grid~     at month 4. During follow-up a ranibizumab injection will be performed every 2 months in~     case of best-corrected visual acuity decreased more than 5 letters.~   "
94229|NCT01823952|"~     A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera~     comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS,~     HAMS 6% Acetate HO-ORS and HO-ORS.~      The primary hypothesis is that at least one of the hypo-osmolar ORS containing high amylose~     maize starch 6% acetate (HAMSA6-HO-ORS), hypo-osmolar ORS containing high amylose maize~     starch 2.5% acetate (HAMSA2.5-HO-ORS) and a hypo-osmolar ORS containing high amylose maize~     starch (HAMS-HO-ORS), will significantly reduce diarrhea duration compared with hypo-osmolar~     (HO) ORS.~      Specifically, the investigators expect that HAMSA6 will be the most effective preparation.~   "
94230|NCT01823939|"~     This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are~     grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients.~     This is not a hypothesis-driven research study.~   "
94231|NCT01823926|"~     Introduction: Inhalation therapy has been established as an efficient route to treat asthma~     exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.~      Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and~     radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using~     vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation~     (NIV).~      Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in~     a crossover study. Patients was randomly assigned to participate in both phases of the~     study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used~     to inhaler using JN positioned in the circuit using a T piece, particle size generation in~     a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the~     mask, particle size generation in a one range and connected to electrical energy. NIV was~     used a bilevel pressure through a face mask attached with straps and pressure adjusted were~     12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After,~     radioactivity counts were performed using a gama camera and regions of interest were~     delimited. To calculate aerosol mass balance the investigators considered the amount of~     radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit,~     inspiratory and expiratory filters, and mask divided for each of these compartments and~     represented as a percentage.~   "
94235|NCT01823874|"~     Clinical benefits of VR analgesia have been empirically demonstrated as either an~     alternative or in combination with opioids. Issues of cost, ergonomics, and maintenance of~     the hardware systems have limited the wider use of this benefit to the public. Firsthand~     Technology has designed a system to meet the performance requirements for high levels of~     pain control in a durable, ergonomic package at a greatly reduced cost compared to the~     current systems in use. This study will validate the new system by running a thermal pain~     study that tests the effect of the new system (ID) compared to the established standard~     helmet currently used.~   "
94236|NCT01823861|"~     An individual randomised controlled trial (RCT) to evaluate the effectiveness of a~     voice-based mobile phone health (mHealth) intervention to support post-abortion family~     planning (PAFP) at four Marie Stopes International clinics in Cambodia.~      The study seeks to address the research question: does a PAFP mHealth intervention increase~     use of contraception in Cambodia?~   "
94237|NCT01823848|"~     Functional constipation is extremely common in children and is defined as painful, hard~     stools or firm stools for twice or less per week. Functional constipation accounts for 3% of~     general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation~     and fecal impaction can lead to a range of symptoms including decreased appetite, vomiting,~     and abdominal pain frequently resulting in Emergency Department (ED) presentation. In~     contrast to the outpatient setting where diet and oral medications work well to relieve~     symptoms related to functional constipation, ED management requires an approach with quicker~     results. For immediate relief of symptoms, disimpaction via enema use may be better than~     polyethylene glycol (PEG) 3350 for children. However, the type of enema to be used is not~     well studied. Currently, any patient presenting to the ED with a presumed diagnosis of~     abdominal pain due to functional constipation receives an oral dose of PEG and one of the~     following three types of enemas (based on the ED treating attending's discretion): phosphate~     or Fleets enema, normal saline enema, or mineral oil enema. There is no evidence in the~     literature that demonstrates any difference in the effectiveness of each of these enemas.~     The investigators propose a randomized control trial of the three types of pediatric enemas~     readily used in our ED to determine the best approach. There will be three arms within this~     study: a) PEG plus phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral~     oil enema. The physicians enrolling patients will not be the treating physicians. The four~     principal investigators (blinded to the type of enema being used), following appropriate~     informed consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and~     post-administration of each of the three treatments listed above in order to determine the~     best enema to use in children 4-12 years of age. Other outcomes to be analyzed will include~     the patient's weight pre- and post-administration of the enema, satisfaction ratings on a~     visual analog scale from the treating physician (who will also be blinded), and parental~     surveys on the day of administration and 3-5 days following discharge. Data analysis for~     pain scores will be completed with repeated measures anova. Categorical values will be~     compared using Chi Square analysis and continuous variables will be compared using~     parametric statistics.~   "
94238|NCT01823835|"~     This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety,~     pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in~     combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase~     Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent~     will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in~     period for single dose PK evaluation prior to the start of daily treatment. The incidence of~     dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28~     days) of treatment (35 days total). Depending on safety and tolerability, participants will~     be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During~     Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with~     palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess~     the safety and tolerability of concomitant administration. During Phase IIa (dose expansion~     phase), participants previously treated with an aromatase inhibitor (AI) will be treated at~     the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity~     of GDC-0810.~   "
94239|NCT01823822|"~     This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to~     investigate whether oral milk protein supplements led to increase in serum Insulin-like~     Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric~     supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested~     product or control product for 4-week, followed by a 4-week follow-up.~   "
94240|NCT01823588|"~     A number of strategies have been evaluated to improve the prevention and control of the main~     cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized~     lifestyle educational programs were found to improve blood pressure (BP) control and~     adherence to healthy lifestyle. This study aims at evaluating for the first time the~     efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors~     among hypertensive adults.~      Participants will receive usual care and a guideline-based educational program on BP control~     and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email~     alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder~     program on the compliance with a healthy lifestyle based upon current guidelines for CVD~     prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment;~     randomization will be made centrally and blood samples will be evaluated into a single,~     accredited laboratory.~   "
94241|NCT01823575|"~     Malignant ureteral obstruction often necessitates chronic urinary diversion and is~     associated with high rates of failure with traditional double-J ureteral stents. To overcome~     drawbacks of the double-J stent, recently, metallic stents have been used to manage for~     palliative treatment in patients with ureteral obstruction associated with end stage~     malignant disease. The success rates of metallic stents have been reported to be high and~     the method proved to be useful in patients with malignant ureteral obstruction. In addition,~     covered metallic stents have many advantages compared with bare metallic stents, such as~     lower rate of tissue invasion and higher patency rate. However, there is little~     investigation about comparison of clinical efficacy between covered-metallic stents and~     double-J stents in malignant ureteral obstruction.~      Therefore, investigators plan to perform a prospective randomized study to compare clinical~     efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients~     with malignant ureteral obstruction.~   "
94242|NCT01823562|"~     This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in~     black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us~     design future chemoprevention studies and assist in making future dietary recommendations~     for men at high risk for prostate cancer.~   "
94243|NCT01823549|"~     This study was a survey to determine the frequency of Complementary and Alternative Medicine~     (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting~     radiation therapy. The survey was repeated at three time points to assess changes in CAM use~     over time.~   "
94249|NCT01823471|"~     Hereditary non-polyposis colon carcinoma (HNPCC or Lynch-Syndrome) is a rare cause of~     colorectal cancer caused by a gene defect in the so -called mismatch repair genes. Patients~     can present at young age with colorectal cancer and polyps can develop faster to malignant~     lesions in comparison to classical sporadic adenomas. New advanced imaging modalities with~     high definition images and virtual chromoendoscopy have a theoretical advantage to improve~     detection and to increase polyp detection. In patients with HNPCC polyp detection has been~     shown to be increased by classical chromo-endoscopy and by high definition endoscopy with~     narrow band imaging (NBI) (a virtual chromo-endoscopy modality activated by a button on the~     endoscope), in comparison to white light endoscopy. However, in these back-to-back studies~     there was no randomization for the order of imaging modality. It is therefore not clear~     whether really the image enhancement adds to increased polyp detection or if this is~     achieved by a second inspection of the mucosa. In this trial the investigators want to~     assess the real additional value of virtual chromo-endoscopy for polyp detection in patients~     with the Lynch syndrome. The investigators will use the high definition pentax system and~     will compare white light endoscopy to i-scan, the incorporated virtual chromo-endoscopy mode~     in this system.~   "
94250|NCT01823458|"~     Incentives are increasingly being used to motivate health behavior in medical studies. Small~     cash payments conditional on certain health and welfare promoting behaviors have shown~     efficacy in both real world and experimental settings. Furthermore, in incentive studies,~     behavioral economics has been shown to amplify behavior change beyond what is possible with~     simple cash payments, but little is known about how varying incentive payment design may~     impact health behavior. The goal of the present study is to evaluate a new incentive payment~     instrument, lottery insurance, to determine its impact on adherence to the target health~     behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a~     safety-net medical clinic.~   "
94251|NCT01823445|"~     The purpose of this study is to demonstrate whether decay causing bacteria are reduced when~     adhesive xylitol disks are used intraorally three times a day for two weeks in adults with~     dry mouth.~   "
94252|NCT01823432|"~     Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but~     very little is known about the genetic causes or risk factors for adverse outcomes.~     Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years~     old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the~     ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan~     to use individual genetic information to identify persons with BAV who are at high risk for~     complications and to customize therapies.~   "
94253|NCT01823419|"~     The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3~     fatty acids on executive functions. The investigators hypothesize that participants ages 7-9~     years with a ratio closer to 4:1 will do better on tests of executive function than~     participants with a ratio closer to the purported Western diet norm of 15:1.~   "
94254|NCT01823406|"~     We will perform blood sugar studies to assess changes in metabolic (biochemical processes~     that occur within us) profiles associated with high blood sugar and diabetes.~   "
94255|NCT01823393|"~     To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces~     serious complications due to the procedure, by decreasing the rate of vascular and~     hemorrhagic complications without increasing the rate of ischeamic events.~   "
94256|NCT01823380|"~     The main objective of this study is to investigate the correlation between the rate of motor~     decline and blood levels of Vitamin D total. Secondary objectives are to investigate the~     relationship between blood levels of vitamin D and total disease duration of ALS, forced~     vital capacity, weight loss, age of onset and the start site of ALS.~   "
94257|NCT01823367|"~     This study is a randomized intervention that will test two different approaches reflecting~     diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will~     help address a critical question in the translation of primary prevention research into the~     public health: how much intensity (and thus cost) is required to achieve an effective~     outcome? In addition, the proposed study will address a critical need in diabetes prevention~     that has not received sufficient scholarly attention: the prevention of T2D in children. No~     studies of diabetes prevention similar in scope to the DPP have been performed in~     school-aged children; however, reducing childhood obesity is widely accepted as the primary~     pathway to decreasing the growing prevalence of T2D in the pediatric population.~   "
94258|NCT01823354|"~     Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only~     clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms~     advance the hypothesis that altered dopaminergic transmission is at the origin of this~     condition. RLS usually leads to a sleep fragmentation, which induces sometimes severe~     insomnia most often associated, in clinical practice, to a cognitive complaint (attentional~     in nature). Executive functions in which dopaminergic transmission is heavily involved refer~     to a set of complex functions. At least three of them should be considered during their~     evaluation (ie flexibility, inhibition, and the updating of working memory). These functions~     are among the targets of the alteration of the quality and quantity of sleep. The few~     studies that have focused on the study of the integrity of executive functions in RLS have~     discordant results. The lack of control of key variables in the assessment of executive~     functioning (ie intellectual performance, depressive symptomatology, generalized slowing in~     information processing) and the lack of reference in the theoretical approach in executive~     functions are certainly the two main reasons. Moreover, the question of polysomnographic~     correlates and the reversibility of these cognitive abnormalities after pharmacological~     management of RLS remains unanswered today.~      The main objective of this study is to compare the executive performance of untreated RLS~     patients with a group of matched controls.~   "
94279|NCT01823081|"~     Eligible eyes are randomized to two groups. Group A will receive three intravitreal~     injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of~     combined bevacizumab and fasudil will be performed with the same frequency.~      Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated~     prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be~     performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of~     BCVA and CMT changes.~   "
94908|NCT01814839|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.~   "
94259|NCT01823341|"~     The purpose of this study is to see whether low blood sugar at night can be reduced by using~     a system that turns off the insulin pump automatically. The study system includes a~     continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular~     laptop computer. A The system works by (1) measuring the glucose levels under the skin with~     the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is~     likely to occur, and (3) turning off the insulin pump when the computer program predicts~     that a low blood sugar will occur.~      We have tested the system in the home environment in individuals with type 1 diabetes age 15~     years and older. We have found an indication that the system can decrease the frequency of~     hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We~     are now ready to further test the system in the home environment in a younger age group to~     learn more about its ability to reduce overnight low blood sugar risk.~      This study has several phases and will take about 3 months for a patient to complete.~        -  First, the patient will use the CGM and pump at home for up to 15 days with the help of~          a parent/guardian. This is done to determine if the patient meets our study criteria to~          proceed with the next phase of the study.~        -  If the patient is eligible to continue in the study, the patient will need to use the~          full study system for at least 5 nights at home with the help of a parent/guardian.~          This is done to make sure the patient and parent/guardian are able to use the system~          correctly. The patient may participate in starting and stopping the system at home, but~          the parent/guardian is responsible for making sure it is used as instructed.~        -  After that, the patient will be asked to use the study system each night for an~          additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure~          the system is used as instructed.~      The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in~     the United States and Canada. First a study of children 8 to less than 15 years old will be~     done. Then, a study of children 3 to less than 8 years old will be conducted.~   "
94260|NCT01823328|"~     The purpose of this study is to compare the effectiveness and safety of ketamine and~     etomidate during rapid sequence intubation (RSI).~   "
94261|NCT01823315|"~     The investigators will conduct a trial to determine whether methotrexate single-dose~     treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses~     of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.~   "
94262|NCT01823302|"~     The primary objective of the study was to compare the change in z-scores for growth during a~     120-day study period in children with picky eating behaviors who were randomly assigned to~     receive nutrition counseling only (control group) or nutrition counseling plus an oral~     milk-based nutritional supplement (study group). The secondary objectives of the study were~     to compare the following between the control and study groups: a) dietary macro- and~     micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia;~     and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The~     safety objective of the study was to compare the frequency of adverse events (AE) among the~     control group and study group subjects.~   "
94263|NCT01823289|"~     The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential~     therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal~     infections ([IPFI]; lung diseases caused by fungal infection).~   "
94264|NCT01823276|"~     The objective of the proposed research is to determine if tyrosine, an amino acid found in~     protein-containing foods, will mitigate the cognitive deficits and adverse effects on~     behavior and mood produced by exposure to military stress. This study will be conducted at~     the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.~      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain~     neurotransmitter that is critical for the central nervous system (CNS) response to various~     types of acute stress. Psychological stress increases catecholamine turnover in the brain,~     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and~     human studies have shown that tyrosine supplementation can produce beneficial effects on~     cognitive and physiological functions during exposure to a variety of acute stressors.~      This project will determine if volunteers treated with supplemental tyrosine during~     stressful phases of SERE training experience less degradation in cognitive performance and~     mood than volunteers treated with placebo. Tyrosine or placebo will be administered in a~     specially developed food bar provided to volunteers. The bar is part of a prototype of~     ration-component designed for use during assault operations. A between-subjects, double~     blind experimental design will be employed. Tyrosine, an amino acid found in most~     protein-containing foods, has been tested in hundreds of volunteers without adverse effects.~      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 82~     volunteers complete the study. They will be tested during several portions of SERE. A~     comprehensive but brief battery of cognitive tests, as well as saliva and blood samples,~     will be collected in a manner that does not interfere with ongoing training.~      Hypotheses:~        1. The adverse effects of psychological stress on cognitive performance and mood during~          SERE school will be reduced when volunteers are given supplemental tyrosine compared to~          placebo treatment.~        2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be~          increased by the stressful activities of SERE school.~   "
94265|NCT01823263|"~     The purpose of this study is to determine whether partial sleep deprivation, as compared~     with normal sleep, influences certain metabolic and cognitive parameters, related to food~     intake, hunger and memory functions, when participants are shielded from external time cues.~   "
94266|NCT01823250|"~     This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment~     for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and~     yielding promising preliminary findings. Drug use rates are highest among Hispanic middle~     school youth and to date no treatments have met criteria for Well Established in the~     treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth~     and families is complicated by the fact that these families often differ from mainstream~     populations in culture-related values, beliefs and behaviors that can directly impact~     engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop~     a more powerful treatment capable of addressing these issues began with a Stage 1 study that~     led to the development of a multi-component treatment that includes a flexible manual that~     allows treatment tailoring to the unique characteristics of individual families. CIFFTA~     integrates innovative culturally-based, individually-based, and family-based components to:~     1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and~     increase family protective factors (e.g., strong parent-child attachment), 2) teach~     adolescents skills to effectively manage interpersonal conflicts and stressors and to~     increase motivation to change, 3) deliver psycho-educational and culturally congruent~     material (e.g., modules on immigration stressors) to youth and parents both separately and~     together, and 4) deliver the intervention using a flexible treatment manual that allows the~     clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational~     modules and themes) to the unique characteristics and needs of the Hispanic family.~      This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet~     DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional~     Family Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual~     behavior, and other severe behavior problems, and hypothesized mechanisms of change, in a~     larger and more rigorous Stage II trial. Assessments occur at baseline, 4 months post~     baseline (end of treatment), 10 months post baseline and 16 months post baseline. Should~     this line of research continue to be successful, it has the potential to contribute to the~     field a highly innovative and efficacious treatment for Hispanic drug abusing adolescents, a~     better understanding of mechanisms of treatment efficacy, and also a framework for future~     flexible and tailored treatments that can be used to better address the unique needs of~     other special populations.~   "
94280|NCT01823068|"~     The purpose of this study is to investigate the efficacy and safety of vandetanib, in~     patients with advanced non-small-cell lung cancer harboring RET gene rearrangement. In 2011,~     gene rearrangement between RET and KIF5B gene (fusion) was discovered in a young, male lung~     cancer patient. The following studies showed that this gene rearrangement was critical for~     tumor initiation and maintenance. Of note, the growth and signaling properties mediated by~     KIF5B-RET were diminished after treatment with vandetanib.~      Until now, RET rearrangements have been known in thyroid cancers. Vandetanib, a multi-kinase~     inhibitors with anti-RET activity, is an FDA-approved drug for the treatments of adults with~     metastatic medullary thyroid cancers who are ineligible for surgery and who have progressive~     or symptomatic disease. This study aimed to examine the efficacy and safety of this drug,~     for the treatment of advanced lung cancer harboring RET rearrangement.~   "
94267|NCT01823237|"~     Dystonia is a disease where muscles in the affected body part are abnormally active. This~     may result in abnormal postures. The underlying mechanisms are not known. One proposed~     mechanism is located in the motor area of the brain that controls the coordination of~     muscles, called the motor cortex. It is well known that the motor area of one hemisphere of~     the brain (motor cortex) controls the movement of the opposite side of the body. When people~     perform tasks such as picking up an object or writing there are mechanisms in motor cortex~     that focus the level of activity so that they can do these tasks with a high level of~     precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia.~     Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation~     of the brain. When applied to the motor cortex it can upregulate or down regulate its~     activity. In the present study the investigators will conduct experiments on subjects with~     task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted~     motor activity. The investigators will assess the effects of this intervention using~     objective, subjective and kinematic measures. This is a pilot study and will require further~     research to assess the long-term effects of repetitive TMS on task-specific focal hand~     dystonia.~   "
94268|NCT01823224|"~     The purpose of the study is to learn whether perioperative IV (intravenous) administration~     of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes~     over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic~     cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen,~     it may result in fewer requests for pain-related intervention such as other oral pain~     medications.~   "
94269|NCT01823211|"~     The purpose of this study is further risk stratification of patients receiving implantable~     cardioverter-defibrillator in primary prevention of sudden cardiac death.~   "
94270|NCT01823198|"~     The goal of this clinical research study is to find the highest tolerable dose of immune~     cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell~     transplant to patients with AML and MDS. Researchers want to learn if adding NK cells will~     help make the stem cell transplant more effective in treating the disease. The safety of~     this treatment will also be studied.~   "
94271|NCT01823185|"~     Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous~     coronary intervention (PCI) with stent implantation and during one year after PCI, to~     prevent atherothrombotic complications. However, clopidogrel is ineffective in certain~     patients due to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for~     metabolism of clopidogrel. Therefore, the purpose of this study is to test these patients~     genetically at bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice~     daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years~     or a body weight < 60kg) if they are carriers of the allele 2 or 3 of the mutated gene.~   "
94272|NCT01823172|"~     The investigators plan to study the ability to identify the lymph nodes beyond the sentinel~     lymph node that may harbor cancer using methylene blue dye.~   "
94273|NCT01823159|"~     The objective of this study is to characterize the effects of a single-dose of retigabine on~     cortical excitability in healthy subjects, as quantified by means of TMS.~   "
94274|NCT01823146|"~     This study will investigate the extent to which intranasal oxytocin affects changes in~     social decision making and evaluations of others. Oxytocin is a hormone that naturally~     occurs in the body and the brain and has been shown to be relevant for many behaviors,~     particularly in social situations. Research on the effects of oxytocin in aging is very~     scarce; therefore, the purpose of this research project is to determine the effects of~     oxytocin on socioemotional aging.~   "
94275|NCT01823133|"~     Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in~     healthy subjects~   "
94276|NCT01823120|"~     Between 6% and 30% of people who harm themselves repeat this self-harm within the following~     12 months. The investigators know that people who harm themselves are much more likely to~     commit suicide, but the investigators have no clear evidence about the best way to reduce~     the likelihood of someone harming themselves again.~      Text messaging is now a common form of communication. Previous research has shown us that~     the investigators can use text messages for different types of health care interventions.~     Examples of this include reminding patients of medical appointments, delivering test~     results, to check patient side effects following treatment and to reduce depressive symptoms~     in patients with depression and alcohol problems. The Samaritans have introduced interactive~     text messages (where you can have a conversation by text with their service) and have noted~     an increasing use of this contact with their service.~      This research study is taking place to find out if using supportive and interactive text~     messages can reduce further episodes of self-harm in patients who present to the Emergency~     Department (ED) with self-harm.~      The investigators hypothesize that supportive, informative and interactive text messages~     delivered to patients discharged from an ED after an episode of self-harm will significantly~     reduce the frequency and intensity of thoughts of self-harm and self-harming behaviour in~     patients compared with those receiving only follow-up treatment as usual. A secondary~     hypothesis is that patients receiving the text messages will report a favourable experience~     and an overall satisfaction with the system.~   "
94277|NCT01823107|"~     The purpose of the study is to evaluate the safety and feasibility of the use of Meso~     BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during~     2-stage, tissue expander assisted breast reconstruction.~   "
94278|NCT01823094|"~     Investigators hope to learn more about how to use computed tomography (CT) scans to measure~     blood flow in lung tumors and how it may change in response to treatment. This measurement~     technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce~     3-dimensional images of the body.~      Currently, doctors determine the response to treatment by measuring the size of the tumor.~     Investigators are trying to find out if measuring the blood flow in the tumor is equal to or~     better than measuring the size of the tumor.~   "
94281|NCT01823055|"~     To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic~     organ prolapse in a prospective multicenter, single cohort study.~   "
95897|NCT01801917|"~     This study will assess the efficacy, safety and tolerability of BAF312 administered orally~     in patients with clinically active polymyositis and also in patients with polymyositis who~     have shown inadequate response to corticosteroids and or DMARDs (disease modifying~     antirheumatic drugs).~   "
94282|NCT01823042|"~     Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after~     surgery treatment.So maintain remission medications were routinely given to patients after~     surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium~     glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken~     medicine.There is a treatment blank period between surgery and onset time of maintain~     remission medications.Enteral nutrition has been used in the induction remission and~     maintain remission for CD.May be it can fill the treatment blank period.~   "
94283|NCT01823029|"~     Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's~     Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's~     Disease Patients With Iron Deficiency Anemia.~   "
94284|NCT01823016|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in~     participants with persistent asthma that is inadequately controlled despite current~     treatment.~   "
94285|NCT01823003|"~     This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT)~     in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung~     cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme~     with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To~     evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To~     evaluate the impact of local therapy on overall and disease-free survival.~   "
94286|NCT01822990|"~     Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery~     disease and peripheral arterial disease. This auto-antibodies could activate endothelial~     cells leading to the expression of leukocyte adhesion molecules and increasing the release~     of pro-inflammatory cytokines.~      On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary~     pathogenic event, as it occur before structural changes are evident on angiogram or~     ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local~     coagulation alterations and an increase arterial wall proliferation. This situation s been~     attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free~     radical formation in the context of the pro-inflammatory status found in atherosclerosis.~      Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with~     endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral~     arterial disease.~   "
94287|NCT01822977|"~     The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is~     associated with significant alterations in the healthy fecal microbiome that are similar to~     those seen in persons with an initial episode of clostridium difficile infection (CDI).~   "
94288|NCT01822964|"~     The aim of this study is to assess the possible neuroprotective effects of cooling (targeted~     cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI)~     procedures. From start of anesthesia, until final valve implantation, local cooling (by the~     RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation,~     by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI~     procedure will be continuously assessed during native valve manipulation and during final~     valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological~     testing performed before and after TAVI procedure will assess the effects of the use of~     cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be~     analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between~     cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be~     performed 5 days before and 5-7 days after TAVI to compare the number and total amount of~     cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this~     study is that by local cooling of the brain during manipulation of the calcified aorta and~     aortic valve, the brain might be protected from cerebral ischemic insults.~   "
94289|NCT01822951|"~     The objective of this trial is the global risk-benefit assessment of Cerebrolysin as~     compared to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT).~     In addition, a traditional approach will be taken based on the evaluation of the separate~     risk and benefit domains in comparison with donepezil.~      Global risk-benefit as compared to donepezil will be analyzed by determining whether the~     Cerebrolysin group shows a statistically significant non-inferiority with regard to the~     combined primary safety and efficacy endpoints (weighted multivariate ensemble). The~     endpoints will be combined by a global multivariate non-parametric procedure, weighting the~     safety and efficacy part 50:50.~   "
94290|NCT01822938|"~     Physical exercise has been identified as a major item of many affecting many chronic~     diseases and stroke rehabilitation. It contributes to an improvement in the quality of life~     and to a decrease in the current treatment side-effects and mortality. Stroke in association~     with an inactive lifestyle lead to a decrease in physical capability and causes problems in~     daily activities. The physical capacity and the tolerance for exercise fall simultaneously~     leading to vicious circle of less and less mobility. Therefore, physical activity for the~     health is a valid and relevant way to improve the quality of life and to recover functional~     capacity. The aim of the study is the assessment of the effects of a incentive program for~     physical activity on people following/with stroke.~   "
94291|NCT01822925|"~     To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing~     pain in subjects with diabetic neuropathic pain compared to their baseline values.~   "
94292|NCT01822912|"~     Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher~     rehospitalization rates and mortality than patients discharged to home.~      HF disease management programs have been shown to reduce rehospitalizations in community~     settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).~      This study will investigate the the effect of a heart failure-disease management program on~     the outcome of all-cause hospital readmissions, emergency room admissions and mortality for~     30 days post-SNF admission using 7 component heart failure disease management program.~   "
94315|NCT01822613|"~     To study the safety and efficacy of the combination of LJM716 and BYL719 against currently~     available treatments of physician's choice in previously treated esophageal squamous cell~     carcinoma patients.~   "
94316|NCT01822600|"~     To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration~     of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.~   "
94293|NCT01822899|"~     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The~     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol~     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive~     Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will~     complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710~     eligible subjects will be equally randomized (to complete at least 568 evaluable subjects)~     to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg)~     administered as one inhalation once-daily in the morning via the Novel dry powder inhaler~     (NDPI) + placebo administered as one inhalation each morning and evening via single~     multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one~     inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily~     in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7~     days after the end of the study treatment (Early Withdrawal, if applicable). The total~     duration of subject participation will be approximately 15 weeks.~   "
94294|NCT01822886|"~     Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate~     efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin~     (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL in a selected population of~     patients.~      Objectives will be focused on preliminary dose-response, type of patients, frequency of~     dosing, and safety and tolerability profile.~   "
94295|NCT01822873|"~     The study hypothesis is that patients with dry age-related macular degeneration experience~     visual function impairments such as defects in dark adaptation, glare intolerance, poor~     light transition and reading in low lighting conditions. Studies have shown that patients in~     the early phases of AMD with normal visual acuity commonly reported difficulty with these~     visual functions but there have been no systematic studies evaluating these deficits in this~     population.~      This prospective, exploratory study will include up to 130 patients with dry AMD and 60~     controls. These patients will undergo the following non-invasive visual function testing:~        -  microperimetry with eye tracking~        -  low luminance visual acuity~        -  specialized color vision (cone-specific)~        -  contrast testing and night vision testing.~      High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of~     the central retina using the Spectralis OCT unit. The values of visual function tested will~     be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).~      There are no known risks to the subjects beyond what is normal for standard examinations of~     the eye, visual function testing and standard ocular photographic procedures.~   "
94296|NCT01822860|"~     Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide~     as measured by flow mediated vasodilatation.~   "
94297|NCT01822847|"~     Cortisol is essential for survival. The importance of cortisol response is most apparent in~     patients with partial or complete deficiency of glucocorticoids during stressful events such~     as illness or surgery.~   "
94298|NCT01822834|"~     The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis~     (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple~     clinical institutions.~   "
94299|NCT01822821|"~     Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid~     consumption and/or pain intensity scores after cardiac surgery.~   "
94300|NCT01822808|"~     To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes,~     symptoms, cardiac parameters and functional status of African patients hospitalized with AHF~     and left ventricular dysfunction during 24 weeks of therapy.~      Administration of hydralazine/nitrates will be superior to placebo administration in~     reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain~     natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular~     dysfunction.~   "
94301|NCT01822795|"~     -  BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited.~          Lung volume reduction surgery is infrequently used because of its high morbi-mortality.~          Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA)~          treatment has been recently developed and has been shown to be feasible and associated~          with an acceptable safety profile, while resulting in improvements in dyspnea, exercise~          capacity and lung function. The objective of this study is to analyze the cost~          effectiveness of LVRC treatment in severe emphysema.~        -  METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs~          conventional treatment) will include 100 patients who will be followed up for 1year.~          The primary outcome measure is the 6-month improvement of the 6-minute walk test: the~          percentage of patients showing an improvement of at least 54m will be compared between~          groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global~          cost of this therapeutic option and will compare the cost between patients treated by~          LVRC and by medical treatment alone.~        -  EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in~          severe emphysema. The cost-effectiveness study will assess the medical-economic impact~          of the LVRC therapeutic option.~   "
94302|NCT01822782|"~     The main objective of this study is to assess whether the presence of abnormal vaginal flora~     (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of~     delivery. For this, the primary endpoint will be the proportion of vaginal lesions according~     to the presence or absence of abnormal vaginal flora.~      A more precise qualitative and quantitative study of vaginal flora isolated from pregnant~     women and its association with vaginal lesions will also be conducted.~   "
94303|NCT01822769|"~     The hypothesis of this study is that participation in a formal cardiopulmonary~     rehabilitation program improves aerobic exercise capacity and quality of life over the~     medium term for patients with congenital heart disease with reduced exercise capacity. To~     test this hypothesis, subjects will be randomized to either receive a 12-week~     cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic~     capacity and other physiologic markers improved fitness, as well as assessment of quality of~     life.~   "
94345|NCT01822223|"~     The purpose of this study is to determine which implant-abutment design is more likely to~     promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant~     bone and soft-tissue health.~   "
94304|NCT01822756|"~     This is a study of ruxolitinib in combination with gemcitabine with or without~     nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The~     study will be conducted in two parts.~      Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of~     ruxolitinib when given as described to patients with advanced or metastatic pancreatic~     cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of~     ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be~     selected for use in Part 2 of the study.~      Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary~     clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with~     gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic~     pancreatic cancer.~   "
94305|NCT01822743|"~     The main objective is to evaluate an osteopathic compression of pterygopalatine node in~     healthy subjects and patients suffering from obstructive apnea syndrome (OSA).~   "
94306|NCT01822730|"~     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or~     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical~     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),~     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central~     dopaminergic neurotransmission) of both conditions. Both paliperidone and risperidone are~     second generation antipsychotics，but have same pharmacological effects of antipsychotic~     treatment and paliperidone may have more efficacy and safty.This study was designed to~     examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for~     patients with MAP.~   "
94307|NCT01822717|"~     The purpose of this study was to find out whether a method of nonvisual foot inspection,~     using the senses of touch and smell, helps people with diabetes and visual impairment to~     find new foot problems when they are in early, easily-treated stages. All people in the~     study had regular foot inspections by podiatrists. The results include how people feel about~     the method, whether they actually did check their feet it, and whether the method helped~     them to discover foot problems themselves.~   "
94308|NCT01822704|"~     This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole~     body vibration training program on physical functioning, societal participation and quality~     of life in individuals with chronic stroke. It is hypothesized that the whole body vibration~     program will induce significantly more gain in physical functioning, societal participation,~     and quality of life in chronic stroke patients, compared with the control group.~   "
94309|NCT01822691|"~     The primary purpose of this research study is to assess whether the participant's disease,~     Myelodysplastic Syndromes (MDS), responds favorably to INCB024360. The study will also~     evaluate the long-term outcomes of the participant's disease after they have finished taking~     INCB024360.~   "
94310|NCT01822678|"~     Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration~     study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of~     treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment~     period; subsequently, down-titration (according to the dose steps and the time intervals of~     up-titration) and administration of an established anti-manic therapy during the~     tapering-off period (in patients who discontinued treatment) or entry into a recurrence~     prevention study (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option~     for patients who responded to the study treatment~   "
94311|NCT01822665|"~     This study evaluated the effect of oral fast-dissolving formulations of paracetamol and~     ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic~     examinations were conducted to determine the gastrointestinal damage produced post a 7 day~     treatment regimen.~   "
94312|NCT01822652|"~     Subjects that have relapsed or refractory neuroblastoma are invited to take part in this~     gene transfer research study.~      We have found from previous research that we can put a new gene called a chimeric antigen~     receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them.~     In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost~     all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to~     patients that had neuroblastoma. The infusions were safe and in patients with disease at the~     time of their infusion, the time to progression was longer if we could find GD2 T cells in~     their blood for more than 6 weeks. Because of this, we think that if T cells are able to~     last longer, they may have a better chance of killing neuroblastoma tumor cells.~      Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells~     to live longer. These new genes are called CD28 and OX40. The purpose of this study will be~     to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be~     given to patients with relapsed/refractory neuroblastoma.~      In other clinical studies using T cells, some investigators found that giving chemotherapy~     before the T cell infusion can improve the amount of time the T cells stay in the body and~     therefore the effect the T cells can have. This is called lymphodepletion and we think that~     it will allow the T cells we infuse to expand and stay longer in the body, and potentially~     kill cancer cells more effectively.~      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and~     fludarabine.~      Additionally, to effectively kill the tumor cells, it is important that the T cells are able~     to survive and expand in the tumor. Recent studies have shown that solid tumors release a~     substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an~     attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called~     pembrolizumab.~   "
94313|NCT01822639|"~     The study is designed to estimate the bioavailability of amlodipine and enalapril maleate~     fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril~     maleate tablets. The rational for this study is to provide a more convenient dosing regimen~     for patients. This is an open-label, randomized, single dose, two-way crossover study, in~     which 16 healthy adult male and female subjects will be enrolled and dosed under fasting~     conditions. Each subject will participate in two treatment periods of 7 days each. There~     will be at least 14 days of wash out period between the two dosing periods and a follow-up~     period of up to 21 days after treatment period 2. The total duration of study will be~     approximately 35 days from the start of the first treatment.~   "
94314|NCT01822626|"~     Obesity is one of the leading causes of morbidity and mortality in the industrialised world.~     Evidence is growing that early life nutrition can play a role in behavioural and cognitive~     problems in children and adolescents and is well documented that being overweight and obese~     during childhood can have short- and long-term physical and psycho-social health~     implications.~      This is an individually randomised trial to evaluate the efficacy of a family~     pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged~     4-7 years old. As secondary objectives the investigators evaluate the effect of the~     counselling on dietary behaviours and physical activity.~      The investigators targeted the intervention to overweight children, while obese children~     were referred to specialised care. The counselling targeted diet, physical activity, and~     sedentary behaviours.~   "
94317|NCT01822587|"~     The investigators' recently completed study has provided the first evidence that~     administration of the medication propranolol, following exposure to cocaine cues, can alter~     drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine~     addicted persons. The investigators will attempt to augment this effect by a) doubling the~     number of propranolol-medicated cocaine cue exposure (CCE) retrieval sessions and b)~     increasing the dose of propranolol. It is expected that propranolol treated groups, relative~     to placebo treated groups, will evidence greater reduction of craving, cue reactivity and~     cocaine use during follow-up cocaine cue exposures. Also, these effects will be greater for~     those who receive 80mg of propranolol as opposed to 40mg.~   "
94318|NCT01822574|"~     This research was performed to determine which of the three techniques used by knee surgeons~     at the Mayo Clinic was the most accurate at the surgical removal (resection) of the knee-cap~     (patella) in a symmetric fashion during total knee replacement (arthroplasty). Although all~     three techniques are known to be effective, the three techniques had never been compared to~     one another to determine if one was more effective than the others at resecting the patella.~   "
94319|NCT01822561|"~     -  The goal of the study is to examine the short-term effects and safety of a systemic~          anti-aldosterone medication, eplerenone, in a small group of patients with central~          serous chorioretinopathy (CSCR).~        -  There is currently no standard treatment or therapy for either acute or chronic CSCR, a~          potentially debilitating eye disease.~        -  There is evidence in both animals and humans that high blood serum corticosteroid~          levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina~        -  Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and~          anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that~          decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR~        -  The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled~          prospective fashion for both acute and chronic CSCR.~        -  The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1~          month~        -  Over the course of the month, patients will be monitored for side effects, as well as~          visual and anatomical response to the medication~   "
94320|NCT01822548|"~     The purpose of this study is to evaluate the effect of DPP-IV inhibitor Vildagliptin vs.~     Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes~     patients in metformin failure. Subjects will be followed for 12 months after randomization.~   "
94321|NCT01822535|"~     The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons~     with tetraplegia. Despite the known challenges to the ability of persons with spinal cord~     injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in~     able-bodied (AB) persons, there has been no work to date addressing these issues in persons~     with tetraplegia.~      The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F)~     causes body core temperature to decrease in persons with tetraplegia and if that decrease is~     related to a decrease in mental performance.~      After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are:~      Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately~     1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of~     the persons with tetraplegia will show a decline in mental performance (memory or~     clear-headedness) while only some of AB controls will show a decline.~      The second aim of this study is to determine if a 10 mg dose of an approved blood pressure~     raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core~     temperature and (2) prevent or delay the decline in mental performance in the group with~     tetraplegia compared to the exact same procedures performed on the day with no medicine~     (Visit 1) in the same group.~      Hypotheses (3 & 4): The changes in blood flow to the skin caused by taking a one-time dose~     of midodrine will lessen the decline in Tcore and prevent or delay the decline in mental~     performance compared to the changes in Tcore and mental performance during cool temperature~     exposure without midodrine in the group with tetraplegia.~   "
94322|NCT01822522|"~     This phase I trial studies the side effects and best dose of cabozantinib-s-malate in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment and human immunodeficiency virus.~     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
94323|NCT01822509|"~     This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in~     treating patients with cancers of the blood and blood-forming tissues (hematologic cancers)~     that have returned after a period of improvement (relapsed) after donor stem cell~     transplant. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the~     ability of cancer cells to grow and spread.~   "
94324|NCT01822496|"~     This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with~     chemoradiation therapy works in treating patients with stage III non-small cell lung cancer.~     Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,~     etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than~     crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.~   "
94325|NCT01822483|"~     The purpose of this study is investigate mycophenolic acid exposure through area under the~     curve in renal transplants recipients treated with mycophenolate mofetil and after~     conversion to mycophenolate sodium.~   "
94326|NCT01822470|"~     The purpose of this study is to investigate the prevalence of small intestinal bacterial~     overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient~     procedure with symptoms of functional dyspepsia. In addition, the investigators would like~     to identify the types of bacteria that are present in the small intestines in patients with~     SIBO and compare two different diagnostic tools: microbiologic culture and DNA sequencing of~     bacteria.~      The aim is to compare the microbiota between patients with and without the clinical~     complications of SIBO~   "
94327|NCT01822457|"~     This is a randomised controlled study of patients suffering from intermittent claudication~     (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise~     levels and quality of life.~      IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by~     narrowing or blockage of the blood vessels in the legs.~      The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides~     estimates of the number of steps taken and the amount of distance covered each day.~      This study will be conducted over a period of 18 months at Imperial College Trust's vascular~     outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to~     consider participating. Participants will receive routine diagnostic work up with the~     addition of having their walking distances measured on a lab treadmill. They will also have~     their functional status and mood assessed using a questionnaire. These assessments will be~     carried out a total of five times over the course of the study. Patients will not need to~     make any additional visits to hospital.~      Patients will be randomly allocated to either the NFB group or the control group. Patients~     in the NFB group will be given a FuelBand with instructions on how to use it. All patients~     will be given routine instructions on maintaining activity and target daily walking~     distances. Target walking distances will be programmed into the NFB. Patients in the NFB~     group will be asked to record estimates of how far they have walked each day directly from~     their band. All patients will be contacted by telephone at a pre-arranged time to collect~     recordings.~      Patients will be followed up at their routine 3-month follow up appointment and additionally~     at 6 and 12 months.~   "
94328|NCT01822444|"~     Primary Objective:~      The primary objective is to validate previously identified predictive/prognostic genomic DNA~     and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced~     CRC (a CRC) or metastatic CRC (mCRC).~      Secondary Objective:~        1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed~          advanced or metastatic K-ras mutant CRC and~        2. To determine the progression free and overall survival of patients under first line~          FOLFOX + bvz in aCRC or mCRC.~   "
94329|NCT01822431|"~     This study will examine if one of the following methods: pupillometry, spectral analysis of~     heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect~     early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus~   "
94330|NCT01822418|"~     Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders,~     and several antidepressive agents have been successfully applied. The new melatonergic~     antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in~     schizophrenia for several reasons. The investigators plan to test the efficacy and~     tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the~     investigators plan to enrol 27 schizophrenic patients into an open, single-armed,~     prospective clinical trial with agomelatine.~   "
94331|NCT01822405|"~     The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of~     the fibrosis.~      Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical~     conditions including the treatment of delayed radiation injuries (soft tissue and bony~     radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation~     tissue and produces angiogenesis maintained after use.~   "
94332|NCT01822392|"~     The research evaluates the use of online versions of delivering an effective psychological~     treatment for children clinically referred for serious oppositional, aggressive, and~     antisocial behavior. The goal is to develop models of delivery that reach families in need~     that are not being served by in-person treatment. The project has immediate implications for~     the treatment of children but more generally addresses several issues critical to treatments~     that are based on Internet, telepsychiatry, and related technologies.~   "
94333|NCT01822379|"~     Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin~     cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP~     (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this~     procedure to be both safe and effective for the treatment of vitiligo. The majority of these~     studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme~     that helps to separate the different layers of skin. However, some cell biologists believe~     that the enzyme dispase (which can be used to separate the epidermis from the dermis) is~     less toxic to cells of the epidermis and can result in a greater number of viable~     melanocytes and keratinocytes for transplantation.~      This study will look at the repigmentation rates of MKTP using trypsin to isolate cells,~     versus MKTP using dispase to isolate cells.~   "
94334|NCT01822366|"~     The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral~     Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and~     young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ)~     and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous~     feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a~     group-based TF-CBT intervention to be feasible and acceptable, with promising clinical~     outcomes. In the feasibility study, lay counselors with no prior mental health experience~     delivered the intervention with training and supervision by our team of mental health and~     TF-CBT experts.~      Building on this initial study, the investigators are conducting a RCT to test the~     effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of~     usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS~     grassroots organizations and local Co-Investigators in TZ and KE, both of whom are~     longstanding collaborators with the investigators' US team and are located in mixed urban~     and rural areas, allowing examination of effectiveness in two countries and two settings~     (urban/rural). Using a task-shifting approach, in which lay individuals are trained as~     counselors, the investigators will train six counselors in each country, who deliver 20~     groups in each site (10 rural, 10 urban), resulting in 320 children and adolescents (ages~     7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed~     at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and~     12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay~     counselors from the feasibility study (e.g., local trainers) to train the TZ and KE~     counselors, and these local trainers provide the TF-CBT supervision, while supervised~     themselves by the US-based TF-CBT and mental health experts. The investigators expect this~     trial to yield recommendations regarding an effective intervention for orphans that is~     acceptable, feasible, and includes local responsibility as a means to enhance potential~     sustainability in Low- and Middle-Income Countries (LAMICs). Findings will inform other~     efforts to scale up mental health interventions to address the substantial mental health~     gap.~   "
94359|NCT01822041|"~     This is study in healthy human volunteers to determine the absorption, metabolism, and~     excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).~   "
94360|NCT01822028|"~     Cross-over, tolerability study with healthy subjects taking Zavesca in combination with~     Florastor. Forty-two subjects will be randomized to one of two treatment sequences of~     Zavesca with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability~     and PK endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be~     collected throughout the seventy-four day study.~   "
94335|NCT01822353|"~     In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old~     children is 9%, and the most common allergen is milk. The overall food allergy has been~     reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood.~     In addition, it predicts later development of allergic disease such as asthma. Most of the~     egg and milk allergy is transient and disappears in childhood. Currently, the standard of~     care for food allergy includes strict allergen avoidance. However, oral immunotherapy has~     been under investigation in children milk, egg, and wheat allergy. Previously, induction of~     clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3~     to 13 years. In adults, strict avoidance is still the standard care but there is also~     growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.~      The investigators aim to analyse the results of per oral immunotherapy treatment in severe~     IgE-mediated egg, milk, and nut allergy in adults.~      Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead~     of total allergen avoidance and could desensitization thus be achieved?~   "
94336|NCT01822340|"~     The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/~     Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and~     one dose on every other week (EOW) regime administered for a period of 24 weeks initial~     study.~   "
94337|NCT01822327|"~     This study is designed to advance our development of a treatment for cocaine dependence. The~     investigators hypothesize that clients with high-risk characteristics will benefit from~     enhanced levels of treatment.~   "
94338|NCT01822314|"~     The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel~     followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or~     Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based~     paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions~     at surgery.~   "
94339|NCT01822301|"~     Fat grafting represents a technique with great potential to improve outcomes in minimally~     invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and~     minimally invasive technique over decades of widespread practice in plastic surgery. In our~     current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9~     subjects without adverse event and all have had a significant improvement. Since all methods~     of treatment and evaluation are the same in this study, we will be able to use the data in~     our prior study as additional control data.~      We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts~     will enable successful restoration of tissue volume and craniofacial form. Additionally, we~     hypothesize that the results will be durable and subject quality of life improved.~      Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to~     this single center University of Pittsburgh site research study.~   "
94340|NCT01822288|"~     Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction~     and even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal~     symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol~     valerate (E2V) 1mg & medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine~     estrogens & MPA.~      However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack~     of comparison research about their therapeutic effect on somatic symptoms, psychosomatic~     symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above~     therapeutic effects should be important for choosing a suitable medication. Therefore, the~     aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic~     symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.~   "
94341|NCT01822275|"~     In the current proposed trial the role of the low-dose WBRT (0.15 Gy) would be to safely~     treat the microscopic distant GBM cells outside of the high dose RT region and sensitize the~     gross tumor, while the focal radiation dose (1.85 Gy) to the gross tumor will bring the~     total tumor dose of 2 Gy per fraction which is the standard of care.~      Radiotherapy (RT) has been integral in the treatment of GBM since the 1970s when Walker et~     al. showed that post-operative whole brain radiotherapy (WBRT) offered significant~     improvements in median survival time, and even more so when given with concomitant BCNU~     chemotherapy. Ensuing dose escalation studies found the optimal dose to be 60 Gy. Patients~     could not tolerate escalation to higher doses than 60 Gy with WBRT due to unacceptable~     toxicity. Even with WBRT of 60 Gy, a huge volume of healthy brain tissue was unnecessarily~     treated with high-dose radiation; recurrences with WBRT remained overwhelmingly local.~     Hochberg and Pruitt (1980) found that after WBRT only 3% of recurrences were outside 2 cm of~     the margins of the primary tumor. With the rise of the CT scan in the 1980s and the MRI in~     the 1990s, along with subsequent improvements in three-dimensional conformal radiation,~     partial brain RT (PBRT) became practical since tumor margins could be visualized and~     irradiated more accurately. - Subsequently, WBRT was shown to provide no survival benefit~     over PBRT at the same dosage; - thus, the latter took over as the standard of care.~   "
94342|NCT01822262|"~     To explore the therapeutic effects for treatment of cholecystolithiasis by minimally~     invasive cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy.~     Method： patients with cholecystolithiasis who received minimally invasive~     Cholecystolithotomy with gallbladder reservation and patients with cholecystolithiasis who~     received laparoscopic cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical~     College from May 2011 to December 2013. Patients who received minimally invasive~     cholecystolithotomy with gallbladder reservation as trial group, patients who received LC as~     control group.the overall follow-up period is 1 year. Then the investigators statistically~     analyze improvement of cholecystolithiasis symptoms in every group, thickness of gall~     bladder wall, the gallbladder function and the rate of the recurrence of cholesterol~     gallstone in trial group.~   "
94343|NCT01822249|"~     Rett syndrome is a severe neurodevelopmental disorder that primarily affects female~     children. Rett syndrome is characterized by significant elevation in blood markers of~     oxidative stress. EPI-743 is a novel therapeutic with demonstrated efficacy and safety in~     the treatment of disorders characterized by oxidative stress. The purpose of this study is~     to examine the safety and efficacy of EPI-743 in a population of children with Rett~     syndrome.~   "
94344|NCT01822236|"~     The purpose of this study is to determine whether a craniosacral therapy program are~     effective on disability, quality of life, autonomic nervous system and oxidative stress~     indicators in patients with chronic low back pain.~   "
94346|NCT01822210|"~     Preclinical studies at our institution, using a genetic mouse model of gastric cancer,~     strongly suggest that innervation of the stomach wall is required not only for the~     development, but also for the progression of gastric cancer, and that denervation of the~     stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall~     may represent an effective therapeutic intervention. New treatment options for inoperable~     cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to~     be an attractive possibility. In this pilot study Botox injections will be given by~     gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is~     to obtain data needed to calculate sample size in a larger controlled trial.~   "
94347|NCT01822197|"~     The purpose of this study is to determine whether bright light phototherapy can improve~     depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent~     effects on quality of life and illness recovery. It is hypothesized that phototherapy will~     improve depressive symptoms and decrease length of stay in depressed patients with CF who~     are hospitalized.~   "
94348|NCT01822184|"~     Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal~     storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S). Most~     MPS II patients will present with some degree of neurodevelopmental involvement, ranging~     from severe cognitive impairment and behavioral problems to mildly impaired cognition. This~     is an observational study; no investigational treatment will be administered. The primary~     objective of this study is to evaluate the neurodevelopmental status of pediatric patients~     with MPS II over time and to gain information to guide future treatment studies in this~     patient population.~   "
94349|NCT01822171|"~     Readmission to a hospital shortly after discharge is a common and costly problem. In the~     United States patients with a diagnosis of heart failure currently experience an elevated 30~     day readmission rate of approximately 20%. By providing patients with medication related~     counseling at discharge by a pharmacist, home medications at discharge, and seeing the~     patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after~     discharge, the study anticipates achieving its primary goal of showing a reduction in the~     readmission rate. Secondary goals are: 1) to determine patients understanding of the~     medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge~     counseling service, and 3) determine the number of interventions made and benefit of the MTM~     clinic.~   "
94350|NCT01822158|"~     This study is to determine if using a standardized debrief checklist after vaginal delivery~     improves communication between the vaginal delivery health care team members and if using~     the checklist increases a sense of enhanced communication between team members.~   "
94351|NCT01822145|"~     The primary hypothesis is that an ICD shock may be predicted days in advance by a combined~     score derived from different data obtainable from the ICD~   "
94352|NCT01822132|"~     The purpose of this protocol is to learn more about impulsive decision making in people who~     use methamphetamines. The investigators would like to know if a medication called naltrexone~     changes how people make decisions. The investigators would also like to know whether changes~     in decision making can be observed by MRI (magnetic resonance imaging).~      The research is conducted in Portland, OR.~   "
94353|NCT01822119|"~     The rationale behind this clinical performance investigation is to collect data regarding~     the usability of the Baha Attract System in patients with hearing impairment that are~     candidates for Baha surgery:~        -  To describe the expected hearing performance with the Baha Attract in comparison to~          unaided hearing thresholds or a pre-test situation using a sound processor together~          with a softband~        -  Which sound processor to select, i.e. BP100 vs BP110~        -  Improve the fitting process for the sound processor~        -  Selection of sound processor magnet at time of fitting and over time~   "
94354|NCT01822106|"~     GERD is due to gastric content reflux to esophagus cause symptom and complication including~     intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because~     the changes of dietary habit, and improvement of examination skill and data analysis, the~     prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence~     is 25% in Taiwan community.~      Although proton pump inhibitor (PPI) can inhibit gastric acid secretion, relief symptom and~     enhancing repair of esophageal damage, therefore, PPI is a main drug for the treatment of~     GRED, but because of PPI has disadvantage of poor compliance, and slow gastric empty time~     and hypersensitivity, and about 40-50% of GERD patients is inefficacy. In addition, PPI~     produces bone fracture, community pneumonia and diarrhea in patient with long-term use.~      Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng),~     Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger). According to~     I-Fang-Chi-Chieh and Shanghonzobinglun recordings that Wu-Chu-Yu tang can treat~     vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach.~      Therefore, the purpose of the present study was to investigate the efficacy of Wu-Chu-Yu~     tang on GRED, and this effect of Wu-Chu-Yu tang compared to PPI Omeprazole.~   "
94355|NCT01822093|"~     Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune~     response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for~     antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host~     Disease. This is a Phase I/IIa open-label safety study, assessing the effects of~     administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post~     haematopoietic stem cell transplant.~   "
94356|NCT01822080|"~     This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the~     treatment of endometriosis.~      There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group~     phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28~     weeks for all subjects who completed the double-blind phase, irrespective of their treatment~     assignment in the first study phase.~   "
94357|NCT01822067|"~     The specific aim of this study is to use MRI methods to evaluate and compare brain structure~     and function in two groups of full-term neonates at two-weeks of age: those born of obese~     mothers and those born to normal weight mothers.~   "
94358|NCT01822054|"~     The specific aim of this research project is to use MRI methods to evaluate and compare~     brain structure and function in normal weight and obese children age 8-10 years.~   "
94361|NCT01822015|"~     This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients~     with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Giving sirolimus together with~     idarubicin and cytarabine may kill more cancer cells.~   "
94362|NCT01822002|"~     To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in~     each type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic~     horizontal canal type).~   "
94363|NCT01821989|"~     Hypothesis:~      Orally ingested lactoferrin has effects on promotion of growth and differentiation of the~     immature gut; also it has immunomodulatory properties, so it will prevent serious infections~     in preterm infants.~      The aim of the study is to:~        -  Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.~        -  Compare two dose regiment of lactoferrin supplementation.~        -  Study effect of lactoferrin supplementation on serum iron stores.~      It is a prospective, randomized, double blind, placebo-controlled study, it will include 180~     preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University~     Hospitals and Manshiet El Bakry Hospital.~      •Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.~      •Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice~     daily.~      •Group C (Controls): Who match the subjected neonates, will receive placebo in form of~     distilled water.~   "
94364|NCT01821976|"~     The goals of the TAOS study is to determine the best procedures for below the knee~     amputations. There are two different procedures currently used by surgeons around the~     county: the Erlt procedure and the Burgess procedure. Proponents of the Ertl procedure~     advocate that the surgical formation of a tibia to fibula bone bridge provides stability,~     shape and weight bearing capability to the residual limb that result in less pain and better~     prosthetic fit and alignment. This procedure is popular especially among the military but~     it's advantages over the Burgess procedure are not well supported by current research. This~     study aims to compare the two amputation procedures in an adequately powered randomized~     trial.~   "
94365|NCT01821963|"~     The goal of this clinical research study is to learn if the antiviral combination of~     telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent~     the virus from coming back after the liver transplant.~      Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination~     at different stages of the HCV infection to stop the virus.~   "
94366|NCT01821950|"~     This study will evaluate the efficacy of yoga taught during school to positively influence~     risk and protective factors of substance use and the initiation and severity of substance~     use. The study hypothesis is that, compared to a control group participating in regular~     physical education classes, subjects who participate in 32 yoga sessions across an academic~     year will improve in negative internalizing behaviors and self-regulatory skills that are~     known risk and protective factors for substance use. This study will also test the~     hypothesis that the yoga intervention will reduce both severity of substance use and the~     degree of substance use initiation.~   "
94367|NCT01821937|"~     The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with~     single oral dose and multiple oral doses in Chinese subjects~   "
94368|NCT01821924|"~     The investigators plan to use retrospective data to assess heart function and structure~     abnormalities through the use of an approved vasodilating agent for stress cardiac MRI~     tests. The investigators are interested in how these MRI findings relate to long-term~     prognosis in people who are at risk for cardiac disease.~   "
94369|NCT01821911|"~     The objective of this study was to achieve the post-marketing safety and immunogenicity~     research of Speeda® rabies vaccine for human use from Chengda Bio~   "
94370|NCT01821898|"~     Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell~     (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus~     (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to~     swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in~     the esophagus and poor growth or weight loss in children~      The main purpose of this research study is to compare the effectiveness of two different~     types of treatment for EoE:~        1. Oral viscous budesonide- which is a steroid medication that has been used to treat~          asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation~          in EoE, and~        2. Specific food elimination.~      The study will also be looking to see if a blood test is useful in following the progression~     of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more~     invasive test.~   "
94371|NCT01821885|"~     The aim of the study is to asses the efficacy of the spirometry and a minimal smoking~     cessation counselling intervention to quit smoking after a year in patients older than 40~     years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary~     disease (COPD) diagnosis.~   "
94372|NCT01821872|"~     Despite its use for decades all over the world, the exact mechanism of action of paracetamol~     is not fully understood and essentially involves a combination of hypotheses. It is known to~     have an effect via the central nervous system, and of the many mechanisms proposed, one~     hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its~     novel metabolite AM404.~      This study aims to elucidate cerebrospinal levels of paracetamol and to measure the~     concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful~     information on the mechanism of action of paracetamol.~   "
94373|NCT01821859|"~     The protocol will study the effect of the combination of two drugs—Abraxane and~     Bevacizumab—on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal~     cancer. This study drug combination will be given to subjects who have already been treated~     for their cancer with other chemotherapy, and now their cancer has become worse or has come~     back again. Neither one of these study drugs has been approved by the FDA for treatment in~     these three types of cancer.~   "
94374|NCT01821846|"~     This trial is conducted in Asia. The aim of this study is to investigate the safety profile~     of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2~     diabetes mellitus.~   "
94375|NCT01821833|"~     Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side~     effects including neuropathy (weakness, numbness and pain) and generalized body aches. The~     latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and~     often occurs in the first three to four days after administration. It affects about 58-90%~     of patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care~     to treat it. However, an intervention with both anti-inflammatory as well as neuroprotective~     properties would be an ideal candidate for testing in the prevention of P-APS and subsequent~     development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty~     acids may act as neuroprotective agents, and there are no currently documented safety~     concerns with their combined use with paclitaxel.~      Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids~     can treat pain in patients with breast or ovarian cancer receiving paclitaxel.~   "
94376|NCT01821820|"~     Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling~     intensely for 75 kilometers will support substrate utilization during exercise (as~     determined through metabolomics) and improve performance compared to water only, and~     attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of~     recovery.~   "
94377|NCT01821807|"~     The aim of the study is to observe the rate of postdural puncture headache observed after~     spinal anesthesia in cesarean section patients.~      Two kind of spinal anesthesia needles will be used:~        1. 26 Gauge Quincke (cutting-tip needle)~        2. 26 Gauge Atraucan (atraumatic needle)~      The investigators will observe:~        1. Number of spinal punctures~        2. Time required for the spinal anesthesia procedure~      Patients will be evaluated after 7 days for:~        1. Headache~        2. Backache~   "
94378|NCT01821781|"~     This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will~     establish engraftment of donor hematopoietic cells with acceptable early and delayed~     toxicity in patients with immune function disorders. A regimen that maximizes host immune~     suppression is expected to reduce graft rejection and optimize donor cell engraftment.~   "
94379|NCT01821768|"~     This randomized clinical trial studies two different tests that are currently being used to~     detect the spread of breast cancer to the lymph nodes under the arm in candidates for breast~     conservation therapy. The two tests are sentinel lymph node biopsy (SLNB) and axillary~     ultrasound. The current standard of care is sentinel lymph node biopsy, which is a surgical~     procedure. Axillary ultrasound (AUS) may be just as good as SLNB for detecting the spread of~     cancer but without the surgical risks.~   "
94380|NCT01821755|"~     The hypothesis of the study is that the intervention leads to a reduction in foster~     children's externalizing problems and foster parents' parenting stress and that this in turn~     leads to a reduction in the number of breakdowns of foster placements.~   "
94381|NCT01821742|"~     A study to determine if echocardiographically derived parameters, plethysmographic~     variability index and pulse pressure variation predict fluid responsiveness in children on~     PICU.~   "
94382|NCT01821729|"~     This is a Phase II clinical trial, which tests the safety and effectiveness of an~     investigational combination of drugs to learn whether the combination of drugs works in~     treating a specific cancer. Investigational means that the combination of drugs is being~     studied. It also means that the FDA has not yet approved it for your type of cancer. Proton~     beam radiation therapy is an FDA approved radiation delivery system.~      Conventional radiation therapy uses photons to treat cancer before patients undergo surgery~     to remove the tumor. In this study we are using radiation with protons, which spares~     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the~     area requiring radiation with no dose beyond the treatment area. This may reduce side~     effects that patients would normally experience with conventional radiation therapy.~      Researchers in the laboratory have discovered pathways inside cancer cells which contribute~     to the growth and survival of tumors. The FOLFIRINOX chemotherapy regimen is a combination~     of the drugs 5-fluorouracil, leucovorin and oxaliplatin. These chemotherapy drugs, along~     with the chemotherapy drug capecitabine, work by blocking these pathways and thereby~     preventing tumor growth. Capecitabine is FDA approved to be used alone or with other drugs~     to treat other types of advanced cancer, but not pancreatic cancer. In past research~     studies, FOLFIRINOX followed by radiation therapy with capecitabine has been identified as~     the most effective and active chemotherapy for patients with cancer that is spreading, and~     this is why we are using it to treat your type of cancer.~      Losartan is classified as an angiotensin-receptor blocker (ARB), and is FDA approved for use~     in people with high blood pressure. Recent studies in people with different types of cancer,~     including pancreatic cancer, have shown that combining chemotherapy drugs with an ARB can~     help reduce/stop tumor growth more effectively than chemotherapy alone. Losartan has been~     used in previous research studies, and information from those research studies suggests that~     this drug in combination with FOLFIRINOX and capecitabine may be better at treating your~     type of cancer.~      In this research study, we seek to determine whether combining FOLFIRINOX with Losartan~     before proton radiation therapy will be more efficient at controlling the growth of or~     shrinking your tumor than just FOLFIRINOX alone.~   "
94383|NCT01821716|"~     The objective of this study is to determine the biologic activity of a Dermatophagoides~     pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be~     used as in-house reference preparation (IHRP).~   "
94384|NCT01821703|"~     The purpose of this study is to investigate the safety and tolerability of LY3045697 after~     multiple doses and to determine how long LY3045697 remains in the body. Each participant is~     expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.~   "
94385|NCT01821690|"~     The purpose of this study is to improve behavior control displayed by persons with traumatic~     brain injury by assessing effectiveness of treatments for post-TBI irritability and~     aggression.~   "
94386|NCT01821677|"~     This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment~     of diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by~     the FDA and will incorporate all safety data from prior FDA approvals. Additional safety~     data will be collected specifically for this low dosage.~      This study will identify a population of subjects where Optina demonstrates a therapeutic~     effect.~      A portion of 505(b)2 drugs are approved based on a single clinical trial.~   "
94387|NCT01821664|"~     Background: Vascular grafts are increasingly implanted due to an increasing prevalence of~     atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by~     infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high.~     However, there are almost no data regarding best treatment options of such complicated~     infections. Most recommendations are based on expert opinion and not on clinical trials or~     cohort observational data analyses. Evaluating infectious and other complications after~     vascular surgery procedures are important, and additionally, such studies may offer insights~     for quality improvement and improved patient outcomes. With the first aim investigators will~     establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage~     of the Swissvasc registry, a central registry which collects preoperative, operative and~     discharge data regarding the index vascular surgical interventions. They will create a~     prospective observational cohort database of all patients who receive a vascular graft~     (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients~     with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a~     focus on the course of this infectious complication. Additionally, investigators will~     establish a biobank with the collection of tissue- and blood samples of patients with PVGI.~     With the second aim researchers will investigate different diagnostic, clinical and~     therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address~     epidemiological questions, such as: determine the incidence and outcome of complications~     after vascular graft placement; determine risk factors, best treatment strategies and~     outcome of PVGI, and determine the influence of different antibiotic regimens on the outcome~     of PVGI due to different bacterial pathogens. Secondly, investigators will determine the~     accuracy of different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and~     their individual role for the assessment of treatment response. Thirdly, investigators will~     evaluate the bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid~     (RNA)amplification, and investigators will explore whether this bacterial diversity does~     predict disease progression. Here, investigators will also study the impact of negative~     pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI.~     Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count,~     C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will~     look at histopathological features of excised vascular grafts. Expected value of the~     project: Results from the proposed study are an important contribution to the field, based~     on the large sample size, longitudinal design and by unifying clinical and epidemiological~     science. The very well characterized patient groups and the close connection between~     vascular surgeons, infectious disease specialists, specialists in nuclear medicine and~     microbiologist will help to investigate PVGI in depths. Investigators hope to be able to~     develop guidelines regarding best diagnostic modalities and treatment options in case of~     vascular graft infections. In the future we plan to examine bacteria retrieved from the PVGI~     in the laboratory in detail. The recovered bacteria will be examined for antimicrobial~     susceptibility and their capability to form biofilms. Furthermore investigators will examine~     how bacterial recovery form explanted grafts could be optimized.~   "
94388|NCT01821651|"~     Objectives:~      Goal of the study is to investigate the potential benefit that transcatheter interventions~     such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage~     Closure and catheter Ablation can gain from multimodal image fusion techniques as they are~     available in the Hybrid suite.~      Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and~     contrast agent, to shorten the operation time (efficacy), and to increase the quality of~     care (safety).~      This pilot study aims at observing these aims on a small patient population and a control~     group.~      Number of Subjects:~      140 patients total in 6 groups:~        -  MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in~          stage).~        -  MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).~        -  TAVI with HeartNavigator lead in (10)~        -  TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).~   "
94389|NCT01821638|"~     Cognitive impairment, commonly reported as difficulty with memory and executive function, is~     a widely recognized clinical challenge for older persons with heart failure (HF). Little is~     known about the relationship between brain MRI and cognitive impairment in older persons~     with HF. A limited number of studies have investigated brain MRI in adults with HF and~     produced conflicting results. Previous findings are limited by use of lower resolution~     scanners (1.5 Tesla), lack of MRI techniques (i.e. combining structural sequences with~     perfusion sequences) and recruitment of mixed age samples. Based on these limitations, the~     purpose of this research plan is to explore the relationship between brain MRI and cognitive~     impairment in older persons with HF using high resolution structural and perfusion scans. To~     accomplish this goal, investigators will compare 40 adults with HF who are age > 65 years~     old with 40 healthy, gender, age, and education matched controls. Investigators will obtain~     neuropsychological measures of multiple domains, as well as MRI measurements of the temporal~     lobe and prefrontal cortex at baseline and 12-months.~   "
94390|NCT01821625|"~     This study will provide chronic hepatitis C (CHC) patients with low platelets (less than~     75x10^9/L) the opportunity to undergo treatment and possible cure of their virus. The main~     hepatitis C drugs will be administered as standard of care, with the addition of the study~     drug eltrombopag.~      The investigators hypothesize that providing eltrombopag to CHC patients with low platelets~     (less than 75x10^9/L) will permit the initiation and completion of antiviral triple therapy~     with boceprevir, ribavirin, and pegylated-interferon.~   "
94391|NCT01821612|"~     This pilot clinical trial studies combination chemotherapy and radiation therapy before~     surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer.~     Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin~     calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill~     any tumor cells that remain after surgery.~   "
94392|NCT01821599|"~     The accelerated rehabilitation and early return does not seem to be harmful, but still needs~     further research to define the rehabilitation time is what shows Kruse and collaborators~     (2012) in their study of systematic review. The surgical treatment of anterior cruciate~     ligament injury is the gold standard in the treatment of these injuries in young and active,~     the postoperative rehabilitation is extensive and full return to sport occurs only after 6~     months postoperatively. Based on this gap, the investigators seek to draw properly through~     our study methods and more complex techniques, that comparing two rehabilitation programs~     can achieve high precision early rehabilitation. This will include 32 athletes who had~     complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar~     tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after~     surgery with: KT1000 measures the ligamentous laxity, knee function by applying the~     International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex).~     Through a random draw of sealed envelopes, patients will be allocated in their~     rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively,~     fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular~     Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and~     the patients were blinded to treatment group. This study will have the locus Institute of~     Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the~     two groups are analyzed using specific statistical tests to prove an improved significative~     without damaging the integrity of the graft.~   "
94393|NCT01821586|"~     Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths~     in developing counties. Physiologically, malnourished children excrete lower amounts of~     salts and water in diarrhoeal stools, and they also are unable to handle excessive salts and~     water load. Some times they are found to be hyponatraemic due to the shift of sodium inside~     the cells (inefficient Na+ /K+ pump), and fluids containing higher amounts of sodium (such~     as the standard ORS) may lead to further increase in the intracellular sodium, fluid~     overload and heart failure. They also have depleted in potassium stores in the body.~     Recently, the WHO recommended a special ORS formulation, known as ReSoMal, for management of~     diarrhoea in severely malnourished children that contains a lower amount of sodium~     (45mmol/L) and higher amount of potassium (40 mmol/L) than the standard WHO-ORS. It is felt~     that an ORS containing lower sodium and higher potassium concentration may be useful in~     correcting hypokalemia, and in lowering the risks of excess sodium and /or overhydration, in~     severely malnourished children with diarrhoea. The safety of ReSoMaL is, however, still in~     question due to the risk of hyponatraemia, including symptomatic hyponatraemia, especially~     in the treatment of severe watery diarrhoea due to Vibrio cholerae and ETEC where loss of~     sodium in the stool exceeds than that is contained in ReSoMal. Thus an ORS solution with~     modest concentration of sodium (75 mmol/L) and higher concentration of potassium (40 mmol/L)~     have been suggested for the treatment of diarrhoea in these children. To improve the~     efficacy of oral rehydration, in terms of reducing the severity of purging and diarrhoea~     duration, different approaches (changing the substrates/ reducing the sodium and glucose~     concentration and osmolarity) have been tried with limited success. Benefiber (partially~     hydrolysed guar gum), a soluble fiber if added to a ORS solution is expected to be fermented~     in the colon liberating short chain fatty acids (SCFAs). SCFAs stimulate sodium and water~     absorption from the colon, and they have trophic effect, act as a fuel source for the~     colonocytes, have antibacterial properties and stimulates the production commensal flora,~     thereby may enhance recovery from acute diarrhoea in severely malnourished children. The~     aims of our proposed study are to examine whether an ORS solution with a modest~     concentration of sodium will prevent the occurrence of hyponatraemia including symptomatic~     hyponatraemia, and also whether addition of benefiber will improve the efficacy of ORS~     solution. This will be a randomized, double blind, controlled clinical trial in 186 children~     with severe malnutrition and watery diarrhoea (62 in each of the three treatment groups) to~     compare the efficacy of (i) the currently recommended ORS with some modofication(Na+ 75~     mmol/L and K40 momol/L and minerals-Zinc, copper and magnesium), (ii) ReSoMal (Na+ 45~     mmol/L), (iii) Currently recommended ORS (Na+ 75 mmol/L, K 40 momol/L and added minerals)~     with added Benefiber (25 grams/L), in the treatment of acute watery diarrhoea in children~     with severe malnutrition~   "
94394|NCT01821573|"~     The aim of this randomized controlled study is to quantify the modification during~     locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris~     and Triceps Surae induced by botulinum toxin injection type A.~      The main hypotheses of this study based on previous studies are that botulinum toxin~     injection increases on one hand the length of the muscle injected during gait and on the~     other hand decreased the strength of the muscles injected.~      The investigators also hypothesized that botulinum toxin injection improved the strength of~     the antagonist muscles and normalized the pattern of strength of the muscles injected during~     gait.~   "
94407|NCT01821404|"~     This single-center, randomized, double-blind trial assesses the impact of short-term~     atorvastatin administration on proliferation activity, apoptotic rate and histological~     inflammation in prostate tissue.~   "
95113|NCT01812161|"~     Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP),~     androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the~     Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more~     efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.~   "
94395|NCT01821560|"~     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a~     functional candidate gene association approach (of dopaminergic addictions-targeted~     polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor~     agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive~     smoking reminders (cues that motivate continued smoking and relapse). These studies will~     provide a means to identify an appetitive cue-sensitive pharmacologic-responsive~     endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to~     treatment, smoking cessation treatments can be structured to meet individual needs, which~     will significantly improve treatment outcome.~   "
94396|NCT01821547|"~     Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world.~     Because of this it is a useful vaccine in which to develop new methods for studying immune~     responses. Measuring the immune response to vaccines helps us to understand how they work~     and whether they are likely to protect any individual against infection. For most vaccines~     we measure the immune system's production of antibody after a vaccine has been given. The~     investigators want to develop new methods that give a far more detailed picture of the~     antibody response to vaccines than has previously been possible. These methods will~     investigate the genetic instructions used by each antibody producing cell to make antibody.~     These methods have the potential to give new insights into the way vaccines work, which~     could be applied to studying vaccines and vaccine schedules in the future.~   "
94397|NCT01821534|"~     This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle~     Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape~     Classification for evaluating a patient's lower facial shape.~   "
94398|NCT01821521|"~     Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and~     Pantoprazole 40mg in healthy male subjects~      Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in~     healthy male subjects~   "
94399|NCT01821508|"~     This is a prospective, open, randomized study involving 72 patients with microvascular~     complications of type 2 diabetes mellitus and obesity, who will undergo gastric bypass~     (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm).~      The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control~     of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2.~      The medical community is confronted with many different studies using various methodologies~     to investigate the best pharmacological treatment for type 2 diabetes mellitus. The~     treatment algorithm offers several different options according to the stage of the disease~     (which is different in each study). In addition, new drugs are being developed over the~     years, but are not always a guarantee of effective type 2 diabetes mellitus control [MENDES,~     2010]. Furthermore, these drugs do not prevent the development of this disease, consequently~     increasing the risks of microvascular and macrovascular complications.~      Conversely, there is considerable evidence that surgery can be an adequate tool to promote~     type 2 diabetes mellitus remission in patients who are unresponsive to clinical treatment.~     Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its~     effects on microvascular and macrovascular complications of type 2 diabetes mellitus have~     not been established. Specialists suggest that the rapid and uncontrollable decrease in~     blood glucose adds to the concern that the surgery may paradoxically cause exacerbation of~     microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose~     before gastric bypass surgery may prevent this paradoxical worsening, leading to an~     interruption of this process, or even retinopathy, nephropathy, and neuropathy remission.~      However, there are no studies comparing the results of these two types of treatment~     (clinical vs. surgical) in a similar population and assessing the development of~     microvascular complications of type 2 diabetes mellitus. Therefore, in order to clarify such~     doubts, it is necessary and extremely desirable to conduct a randomized controlled trial~     comparing gastric bypass with the best and most modern clinical treatment. Its findings~     could have a direct impact on hundreds of millions of diabetics by allowing the inclusion of~     surgical treatment as a safe and feasible therapeutic option for a significant portion of~     these patients.~   "
94400|NCT01821495|"~     Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with~     nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment~     failure. A series of studies reported that dendritic and cytokine-induced killer cells~     (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis~     of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after~     concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the~     efficacy of DC-CIK for NPC.~   "
94401|NCT01821482|"~     The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced~     Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).~   "
94402|NCT01821469|"~     This research project follows two main objectives: 1) Assess anatomical and functional~     cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes~     after the application of a psychoeducational program in these patients. Specifically, this~     project aims to assess neurophysiological (fMRI - activation and functional connectivity)~     and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to~     bipolar disorders and the therapeutic response to the psychoeducation. The results of this~     thesis project would also contribute to the validation of a pathophysiological model of the~     bipolar disorder.~   "
94403|NCT01821456|"~     The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study~     assessing risk factors, interventions, and outcome of immunosuppressed patients with or~     without opportunistic infections.~   "
94404|NCT01821443|"~     The purpose of this study is to find out what effects, good and/or bad, stereotactic~     radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of~     giving radiation therapy to the brain in a very focused way, so that nearby parts of the~     brain receive very little exposure to radiation. No incisions are involved. Imaging~     technology is used to pinpoint the location of the tumor.~      In this study, the investigators are also trying to find out how the tumor and/or treatment~     affect brain function over time. The investigators will do this by performing a series of~     neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before~     treatment and at regular intervals after treatment.~   "
94405|NCT01821430|"~     Managing pain in patients who abuse prescription opioids presents many challenges, including~     the development of opioid-induced hyperalgesia (OIH). Hyperalgesia is a condition in which~     something that usually feels slightly painful is perceived as something very painful. The~     proposed study will test the efficacy of the well-known neurological medication pregabalin~     to diminish OIH and chronic pain in persons who are in Suboxone (buprenorphine) or methadone~     treatment for prescription drug abuse.~   "
94406|NCT01821417|"~     The study will compare initial peri-implant bone healing and longitudinal osseointegration~     between a fully microtextured dental implant and an analogous implant with a smooth machined~     collar.~      The investigators hypothesize the fully textured implant will result in less peri-implant~     crestal bone resorption than the implant with a machined collar.~   "
94408|NCT01821391|"~     This study will be conducted as a multi-centre, randomized, investigator-blind, active and~     vehicle-controlled, intra-individual study.~      The purpose of this study is to confirm that the Metvix NDL-PDT procedure is similar in~     efficacy and less painful when compared to Metvix c-PDT procedure for the treatment of mild~     and moderate AKs.~      In addition this study will include a Metvix NDL-PDT arm versus Metvix vehicle cream c PDT~     (Placebo) to assess the sensitivity of the trial.~   "
94409|NCT01821378|"~     The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in~     subjects with an acute exacerbation of schizophrenia.~   "
94410|NCT01821365|"~     Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when~     people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect~     the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect~     PaCO2 in COPD patients.There may be several reasons for this discrepancy. Due to airway~     obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar~     concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with~     PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to~     5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.our study~     mainly focus on two issues.First, to explore the optimal depth of tube placed when patients~     with COPD breathe spontaneously or receive noninvasive ventilation, and compare the~     differences of two condition at the same time. Secondly, to evaluate the agreement between~     the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation~     when our extension tube locates in the optimal position, and investigate whether~     PETCO2（5s）can be used to monitor ventilation status dynamically.~   "
94411|NCT01821352|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in reducing circumference of the waist, hips and upper abdomen in obese individuals.~   "
94412|NCT01821339|"~     The purpose of this study is to determine whether displacement on one or all of the standard~     radiography views done within 6 months and 1 year after a pelvic injury is related to health~     related quality of life outcomes of patients with an isolated pelvic ring injury.~   "
94413|NCT01821326|"~     The investigators investigated the rebleeding rate the risk factors for rebleeding after~     long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure~     gastrointestinal bleeding.~   "
94414|NCT01821313|"~     The purpose of this study is to examine the effects of high intensity interval exercise~     (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our~     working hypothesis is that, compared with obese children prescribed moderate exercise, obese~     children prescribed HIIE will demonstrate greater improvements in endothelial function and~     inflammatory markers following a 6-week exercise intervention.~   "
94415|NCT01821300|"~     The purpose of this research study is to determine which measures best capture~     cardiovascular disease (CVD) risk and type 2 diabetes (T2DM) risk in children and~     adolescents with Down syndrome (DS).~      We hypothesize that DS is associated with worse cardiometabolic risk factors for a given~     body mass index compared to controls. This difference arises at least in part, from~     increased fat tissue.~   "
94416|NCT01821287|"~     The purpose of this study is to understand the causes of growth failure and to define~     biochemical markers of nutritional failure in patients with single ventricle Congenital~     Heart Disease (CHD).~   "
94417|NCT01821274|"~     The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause~     irritation to skin on the back of healthy volunteers after repeated application over~     21-days.~   "
94418|NCT01820442|"~     The primary objective of this study is to assess lofexidine related effects on QTc (an~     interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary~     objectives of the study are to evaluate the safety and tolerability of lofexidine by~     evaluating and monitoring pharmacokinetics (amounts of drug in the blood), vital signs~     (heart rate and blood pressure) and adverse events (side effects) when co-administered with~     buprenorphine; to describe effects on opiate withdrawal when lofexidine is introduced~     following a 50% buprenorphine dose reduction, as required to elicit a withdrawal response;~     and to evaluate QTc interaction effects of lofexidine compared with placebo. The~     Investigators hypothesize that while lofexidine is known to prolong the QTc interval, the~     combination of the drugs will not create an additive effect which creates a significant~     safety concern. The Investigators further hypothesize that subjects will be able to tolerate~     the therapeutic dose of lofexidine (0.8 mg four times daily) when the buprenorphine~     maintenance dose is lowered to elicit withdrawal.~   "
94419|NCT01820429|"~     The purpose of this study is to compare the response to aspirin in the acute phase with the~     late phase of an acute coronary syndrome.~   "
94420|NCT01820416|"~     The purpose of this study is to determine whether low-level laser therapy can improve~     hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a~     treatment, placebo, or control group. The treatment group will be given a three treatment of~     low-level laser therapy, which consists of shining low-level lasers beams onto the ear and~     head. The laser beams are cool to the touch, and do not cause discomfort. Each laser~     treatment will last approximately 4 minutes. Three treatments will be applied three times~     within the course of one week. Hearing tests will be administered immediately before~     treatment, immediately after treatment, and six weeks after treatment. Results will be~     analyzed to determine the effect of the laser treatment on hearing.~   "
94421|NCT01820403|"~     The study purpose was to evaluate the effects of portion sizes on body weight and energy~     intake in a free-living setting. 223 healthy adults were recruited from an urban worksite~     and randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal~     box lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants~     were required to pick up a box lunch every week day for six months. Control participants did~     not receive a box lunch and were instructed to eat their usual lunch. Participants were~     weighed and dietary intake measured at baseline, one, three and six months. It was~     hypothesized that at six months, participants in the 1600 kcal box lunch would gain more~     weight and have higher energy intake than those in the other groups.~   "
95114|NCT01812148|"~     Review of the investigators hospital experience in cytoreductive surgery and hyperthermic~     intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as~     intraperitoneal chemotherapeutic agent.~   "
94422|NCT01820390|"~     Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of~     motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET).~     Although an effective and relatively safe procedure with expanding indications,~     opportunities exist for the optimization of the current procedure.~      The investigators therefore propose, in a group of patients undergoing DBS surgery for the~     treatment of PD or ET, to use a combination of high‐field imaging modalities, intraoperative~     electrophysiology, external sensor interfaces, and computational modeling, to gather~     information on the utility of using these techniques to optimize DBS electrode placement and~     programming.~   "
94423|NCT01820377|"~     Building on the successes of a communal, relationship based approach to Aboriginal youth~     mentoring in an after school physical activity program (AYMP), the investigators are~     evaluating a peer-led approach for diabetes prevention.~   "
94424|NCT01820364|"~     The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity~     of LGX818 in combination with selected agents.~   "
94425|NCT01820351|"~     The purpose of this study is to establish, through ultrasound, measurements of the thigh~     muscles (Biceps Femoris and Vastus Lateralis)and the chronic effects of a static stretching~     program on the muscle-tendon unit these muscles.~   "
94426|NCT01820338|"~     The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate~     the impact of a community based intervention delivered to families in rural settings~     utilizing the existing Cooperative Extension Service network on child dietary intake and~     weight. Specifically, the E-FLIP for Kids study will determine if behavioral treatments for~     child obesity lead to greater improvement in child weight compared to educational only~     treatment.Participants will include 240 parent-child dyads from ten rural counties in north~     central Florida. Study outcomes will be measure prior to treatment, at the end of treatment~     (month 12) and at one year follow-up (month 24). All treatment meetings will be held at~     Cooperative Extension Service offices within each participating county.~   "
94427|NCT01820325|"~     The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended~     Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week~     carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC.~      The purpose of the Phase II portion of the study was to assess the treatment effect of~     adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and~     paclitaxel on progression free survival (PFS) in patients with previously untreated~     metastatic squamous NSCLC.~   "
94428|NCT01820312|"~     The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy~     drug paclitaxel is effective in treating head and neck cancer that has returned after~     treatment with standard radiation therapy alone, but cannot be removed by surgery. The~     overall total dose received of both the chemotherapy and radiation therapy will be less than~     that typically given as standard of care; however, the Food and Drug Administration (FDA)~     has not evaluated the safety and effectiveness of this combination therapy. In addition,~     this study will gather information about the effects of radiation therapy and chemotherapy~     on subject's overall quality of life.~   "
94429|NCT01820299|"~     This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate,~     lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify~     plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation~     throughout the entire body) in subjects with advanced cancer.~   "
94430|NCT01820286|"~     The investigators are doing this study to see if positive psychology can help adults with~     depression or bipolar disorder.~      Positive psychology involves exercises—short tasks—that try to increase good feelings and~     emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology~     exercises might include imagining a bright future, being grateful for good events, forgiving~     others, and doing kind acts for others.~      The investigators want to see if practicing positive psychology exercises after leaving the~     hospital can increase feelings of hope, optimism, and positive thinking. The investigators~     are asking you to take part in this research study because you are in the hospital for~     depression or bipolar disorder.~      This research study will compare positive psychology exercises to control condition~     exercises. During the study, you may take part in control condition exercises instead of~     positive psychology exercises.~   "
94431|NCT01820273|"~     The purpose of this study is to determine the early changes in gut hormonal, and other~     metabolites with known relations to the glycemic homeostasis. The study mainly focus on~     these responses to food in the diabetic patient, compared to the non-diabetic, after gastric~     bypass surgery. Also aiming for recording changes in the earliest postoperative phase.~   "
94432|NCT01820260|"~     To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily~     treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in~     different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle~     gel~   "
94433|NCT01820247|"~     The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with~     enteral nutrition in the treatment of Crohn's disease for induction remission and compare~     the therapeutic effect with patients who only received Tripterygium Glycosides or enteral~     nutrition.~   "
94434|NCT01821248|"~     To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/~     Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.~   "
94435|NCT01821235|"~     The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between~     different batches of one medicines are smaller than the pharmacokinetic differences between~     two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim~     of this study is to investigate the hypothesis using gabapentin as test product. Therefore,~     the first objective of this study is to investigate the individual bioequivalence - or~     switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is~     to investigate the individual bioequivalence between two different batches of the same~     medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.~   "
94497|NCT01820208|"~     After successful screening, first the investigators first treat patients of severe alcoholic~     hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's~     score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to~     steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non~     responders will be randomized to receive G-CSF for 28days.~   "
94436|NCT01821222|"~     Reducing maternal and newborn mortality remains a global challenge. Because obstetric~     complications cannot be predicted, skilled attendance at the time of delivery and access to~     emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal~     care has the potential to reduce maternal morbidity and improve newborns survival but this~     benefit may not be realized in sub-Saharan Africa where the attendance and quality of care~     is declining. There is a rapidly expanding number of mobile phone users in developing~     countries and due to the potential to strengthen health system the use of mobile phones is~     health care is emerging. The investigators assessed a mobile phone intervention named wired~     mothers aimed to improve maternal and newborn health.~      The hypothesis of the study was that the wired mothers mobile phone intervention would~     increase attendance to essential reproductive health services such as antenatal care and~     skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and~     newborn.~      The objective of the study was to examine the effect of the wired mothers intervention on~     antenatal care, skilled delivery attendance, access to emergency obstetric care and~     perinatal mortality.~      The study was a pragmatic cluster randomized controlled trial with the primary health care~     facility as the unit of randomization. The study took place in 2009-2010 on the island of~     Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected~     facilities were included at their first visit and followed until 42 days after delivery.~     Facilities were allocated by simple randomization to either mobile phone intervention (n=12)~     or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher~     component.~      The perspectives of the study are that mobile phones may contribute to saving the lives of~     women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide~     maternal and child health policy makers in developing countries.~   "
94437|NCT01821209|"~     Placement of an autologous retropubic urethral sling at the time of robot assisted radical~     prostatectomy will improve the recovery of continence after radical prostatectomy~   "
94438|NCT01821196|"~     Preclinical studies at our institution, based on a genetic mouse model of stomach cancer,~     strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of~     stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by~     injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer~     as well as reduces already established tumor volume in the stomach in this mouse model. Gene~     expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The~     expression of PGP9.5 is highly specific for the density of neurons and the diffuse~     neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal~     mucosa either by means of endoscopy and/or from operative specimens from participants~     treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St~     Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with~     immunohistochemistry and gene expression studies for the presence and density of PGP9.5.~     These data will be correlated to stage evaluation (TNM) and survival.~   "
94439|NCT01821183|"~     At this investigation we want to find out whether there is a difference in muscle strength~     of the internal and external rotation hip muscles between soccer players and non-soccer~     players caused by typical movement patterns seen in soccer sport.~   "
94440|NCT01821170|"~     The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most~     frequently found disorder in children. It is characterized by a triad of symptoms involving~     attention deficit, hyperactivity and impulsivity and having an impact on the functioning of~     the subject especially in terms of learning.~      Currently, main interventions to treat ADHD in children are stimulant medication or~     supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs~     (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD~     children. These drugs are generally effective but their nature (psychostimulants) and~     adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics,~     abdominal pain, irritability, nausea and fatigue) encourage the development of new~     therapeutic approaches. The use of supportive psychotherapy alone would have limited effect~     on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation~     program using a virtual classroom in children suffering from ADHD.~   "
94441|NCT01821157|"~     The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless~     (FL) esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD).~     It was hypothesized that the FL surgery would yield similar clinical results to the OF~     technique up to 12 months. Methods: A split-mouth randomized controlled trial will be~     conducted in 28 subjects presenting EGD. Contralateral quadrants will receive ECL using OF~     or FL techniques. Clinical parameters will be evaluated at baseline, 3, 6 and 12 months~     post-surgeries. The local levels of receptor activator of NF-КB ligand (RANKL) and~     osteoprotegerin (OPG) will be assessed by ELISA at baseline and 3 months. Patients'~     perceptions regarding morbidity and esthetical appearance will be also evaluated.~     Periodontal tissue dimensions will be obtained by computed tomography at baseline and~     correlated with the changes in the gingival margin (GM).~   "
94442|NCT01821144|"~     The study is to test whether an education programme targeted at school children can lower~     salt intake in children and their families. In this study, the investigators will educate~     children on how to reduce salt intake, and the investigators will empower children by asking~     them to deliver the salt reduction message home to their families, particularly children~     need to persuade the person who does the cooking for the whole family to cut down on the~     amount of salt used during food preparations. The study will involve children aged about 11~     years, and their parents and grandparents in Northern China.~   "
94443|NCT01821131|"~     This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities~     of flax. The purpose of this study is to find the lowest dose of flax that can lower~     LDL-cholesterol.~   "
94444|NCT01821118|"~     Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called~     amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood~     vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more~     hemorrhages in the brain cortex in individuals 55 years of age or older. This study will~     examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the~     maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30~     and 60. Subjects will be followed for 6 months after receiving the last dose of study~     medication.~   "
94445|NCT01821105|"~     This pilot phase II studies how well computed tomography (CT) and positron emission~     tomography (PET) imaging works in detecting disease in patients undergoing surgery for~     metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before~     and during surgery may help find colorectal cancer and help guide surgery~   "
94602|NCT01818843|"~     Based on the study about carbon monoxide in human inflammatory and other beneficial~     physiological function , now we'll be going to research its application in neonates .Phase 1~     Study as a foundation for the further test is, the safety and Adverse reaction study of~     newborn to inhaled CO~   "
94446|NCT01821092|"~     40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic~     area (from second premolar to second premolar) will be enrolled in the study. At the time of~     surgery, a full thickness flap will be elevated, the implant bed will be prepared according~     to the manufacturer's instruction and the implants will be then seated into the bone. T0~     corresponds to the time of implant insertion, T1 to the time of healing abutment's~     connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from~     healing abutment's connection.~      Cone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment~     connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be~     identified, and measurements will be made at predetermined levels. Horizontal facial bone~     thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be~     measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular~     distance from the implant platform to the most coronal point of the facial bone. Changes~     between T1 and T2 will be calculated.~   "
94447|NCT01821079|"~     The purpose of this study in healthy volunteers is to assess the relative bioavailability of~     PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the~     pharmacokinetics of the tablet formulation.~   "
94448|NCT01821066|"~     A single 125 mg oral dose of the investigational compound PD-0332991 will be administered~     alone and after steady-state dosing of tamoxifen to determine if coadministration of~     tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.~   "
94449|NCT01821053|"~     A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal~     control may offer an attractive explanatory model for the pathophysiology of established PE.~     The channel is activated by plasmin. Microalbuminuria predicts the development of~     pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators~     hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be~     the cause. The investigators want to test the correlation between measurable~     plasmin/plasminogen in the urine early in pregnancy and the development of preeclampsia in~     pregnant patients with type 1 diabetes.~   "
94450|NCT01821040|"~     The study compares the efficacy and safety of modified release prednisone versus immediate~     release prednisone in patients suffering from polymyalgia rheumatica.~   "
94451|NCT01821027|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie,~     how the drug affects the body) of a single dose of simvastatin.~   "
94452|NCT01821014|"~     Much of the basic general medical care and chronic disease management in rural Honduras~     comes from groups of volunteers setting up temporary clinics run by volunteers. These~     clinics, also known as brigades, or medical missions, are often criticized for their lack of~     quality and the lack of follow-up, both of which stem, in part, from understaffing with~     volunteer physicians. This study is designed to assess if it is feasible, safe, and~     acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US~     physicians connected with patients by videoconference.~   "
94453|NCT01821001|"~     Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms~     including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for~     adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine,~     as a therapy based on animal models of the disease and our prior clinical research to~     observe any objective improvement in the extent of the disease using Magnetic Resonance~     Imaging (MRI)and standard measurements for other gynecologic diseases to measure~     symptomatology.~   "
94454|NCT01820988|"~     The objective of this cross-sectional study is to obtain insight in the characteristics~     (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic~     community-dwelling older people. There is one measurement moment and measurements will take~     place at the participant's home.~   "
94455|NCT01820975|"~     In the present study, the effect of habitual dietary protein on the anabolic response will~     be investigated.~   "
94456|NCT01820962|"~     Patients with a hematological malignancy who are undergoing intensive chemotherapy need a~     central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they~     are not used.~      The purpose of this study is to determine whether concentrated citrate locking, compared to~     heparin, reduces the incidence of central venous catheter-related thrombosis and infections~     in patients with hematological malignancies undergoing intensive chemotherapy.~   "
94457|NCT01820949|"~     This study will evaluate clinical outcome after the step-wise implementation of a Patient~     Blood Management (PBM) Program in surgical patients at 4 hospitals.~   "
94458|NCT01820936|"~     The purpose of this study is to compare the effect of food and two modified fasting regimens~     on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy~     adult participants.~   "
94459|NCT01820923|"~     The aim of this study is to determine whether transcranial brain stimulations, such as~     repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current~     stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients~     in vegetative and minimally conscious state.~   "
94460|NCT01820910|"~     Objective of this trial is to establish the efficacy of an upfront targeted therapy~     consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration~     of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection~     re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The~     primary endpoint is the 2-year progression-free survival (PFS) of patients with newly~     diagnosed stage-IE lymphoma treated with the experimental strategy.~   "
94461|NCT01820897|"~     Urinary tract infections (UTI) are the most common complications after kidney~     transplantation. Most series have reported incidence between 20 to 50% during the first~     year. In the most recent report from our center the incidence was 36.6% during the first 6~     months after transplantation.~      The clinical consequence in the graft survival and the association with immunological~     rejection has not been well defined. Nevertheless, the association of UTI with high rate of~     hospitalization and their costs are widely recognized. There is paucity of trials, specially~     randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a~     recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7)~     found only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis~     reduced the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO~     guidelines in transplantation recommend the prophylaxis for UTI with~     sulfamethoxazole-trimethoprim (SMT). Nevertheless, the rate of bacterial resistance to SMT~     has been reported above 50% in almost all the series.~      Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has~     shown a good bioavailability, especially in the urinary tract. It has shown a wide~     antibacterial spectrum, but the important target seems to be enteric bacilli particularly~     Escherichia coli (the most prevalent cause of UTI). FT has also shown a very good activity~     against E. coli producer of Extended Spectrum Betalactamases. Recently, the rate of these~     multi-drug resistant bacteria has increased in our center as evidence of worldwide~     distribution. In addition, the rate of FT resistance has been stable during the last years~     (<3%). This phenomenon could be explained because of the properties of this antibiotic, the~     most important one seems to be related with the unique mechanism of action and the lack to~     propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial~     (randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women~     with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9~     episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance~     during the follow up.~      Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis~     with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI~     in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%),~     65 patients will be needed by group of treatment to demonstrate a difference of 22% in the~     incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is~     the incidence and rate of UTI during the first six months after kidney transplantation. The~     secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and~     titer and number of de novo donor specific antibodies.~      The investigators propose a randomized, double blind, placebo controlled trial to compare FT~     with SMT in the efficacy and safety to prevent UTI during the first six months after kidney~     transplantation. The investigators will include patients from two tertiary-care transplant~     centers. Recruiting and the randomization will be carried out separately by center and~     gender (because female patients have a greater risk of UTI). The medical visits will be~     scheduled monthly and include general laboratory, urine culture and information gathering~     about antibiotic side effects as well as adherence. Rejection rate and the number and titers~     of de novo donor specific antibodies (secondary outcome) will be obtained according to the~     standard of care of the institutional kidney transplantation follow up. These include kidney~     biopsy at days 0 and 90 after transplantation, as well as determination of donor specific~     antibodies after sixth months of follow up. Graft biopsy is also performed whenever graft~     dysfunction exists in the absence of an identifiable cause (infection, urinary graft~     obstruction).~   "
94462|NCT01820884|"~     This randomized trial is studying the efficacy and safety of the hysterectomy alone compared~     with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA~     endometrial carcinoma.~   "
94478|NCT01820663|"~     This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor~     impairment after stroke. It is based on the hypothesis that after stroke, the brain's~     utilization of glucose, it's primary source of energy, is disrupted. The MAD is a~     low-carbohydrate diet that has can switch the body's metabolism from using glucose to using~     products of fat metabolism, so-called ketones. Ketones may act as an alternative energy~     substrate for the brain. Ketones also have several neuroprotective effects after stroke.~   "
94463|NCT01820871|"~     The purpose of this study is to evaluate the effectiveness of smartphone application for~     management of type 2 diabetes mellitus (DM).~      Type 2 DM is an almost incurable chronic disease and continuous management is important for~     long-term prognosis. However, patient's compliance to conventional medical intervention is~     generally unsatisfactory and many patients feel difficult to access to the detail medical~     advice for type 2 DM.~      Thus, the investigators developed a smartphone application for giving programed medical~     intervention to patients according to patients data; blood pressure, fasting blood sugar,~     body weight, calorie intake,exercise amount, etc.~   "
94464|NCT01820858|"~     This randomized trial is studying the efficacy and safety of the chemotherapy compared with~     radiation therapy alone as adjuvant treatment after operation in Patients with high risk and~     Stage I endometrial carcinoma.~   "
94465|NCT01820845|"~     Plethysmographic Variability index is a simple index accurate in predicting fluid~     responsiveness.~      The aim of this study was to investigate its accuracy in predicting fluid response to~     intravenous fluid challenge during scoliosis surgery in children.~   "
94466|NCT01820832|"~     The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.~   "
94467|NCT01820819|"~     The purpose of this study is to determine whether there are reasons other than medical~     reasons that could limit access to liver transplantation in alcoholic patients.~   "
94468|NCT01820806|"~     This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg~     [14C]-radiolabeled GLPG0634.~      The study aims to establish the elimination pathways of GLPG0634 and their relative~     significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.~      Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to~     GLPG0634 will be evaluated.~      This study will also provide safety and tolerability information for GLPG0634.~   "
94469|NCT01820793|"~     Escherichia coli is the primary cause of urinary tract infections and Gram-negative~     bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new~     mechanism of resistance to antibiotics: extended spectrum β-lactamase (ESBL), type CTX-M.~     These ESBL inactivate most β-lactams, the preferred class of antibiotics for the treatment~     of severe E.coli infections. Moreover, the strains that produce these ESBL are often~     resistant to other classes of antibiotics. Their rapid spread constitutes a major public~     health concern because of a serious risk of therapeutic impasse. Treatment options in cases~     of infection with ESBL-producing E.coli are often limited to carbapenems, a class of more~     recently developed β-lactams. Carbapenems have a very wide spectrum of activity but their~     effectiveness is threatened by the emergence of strains producing carbapenemases. The~     development of therapeutic alternatives to treat ESBL-producing E.coli infections is~     therefore essential. Cephamycins, including cefoxitin, are β-lactams marketed in the~     seventies but their use was practically abandoned when wide spectrum antibiotics became~     available. They are distinguished by the presence of an α-methoxy group in position 7 which~     interferes with the action of the extended-spectrum β-lactamase and renders it ineffective~     against cephamycins. Cefoxitin is therefore active in vitro against ESBL-producing E.coli~     and offers the advantage of a narrower antibacterial spectrum, thus reducing the selection~     pressure and the emergence of resistance. However, the in vivo activity of cefoxitin for the~     treatment of ESBL-producing E.coli infections has never been measured. Furthermore,~     available pharmacokinetic and pharmacodynamic (PK/PD) data for cefoxitin are dated and~     incomplete, which raises many questions concerning the optimal dosage regimen. We have shown~     in a mouse model of ESBL-producing E. coli CTX-M pyelonephritis that cefoxitin efficacy is~     comparable to that of carbapenems without selecting resistant mutants. Cefoxitin could thus~     constitute an alternative to carbapenems for the treatment of pyelonephritis caused by~     ESBL-producing E.coli.~   "
94470|NCT01820780|"~     After decompensated heart failure, a number of patients have high risk of early~     rehospitalization as well as death. Specialized medical management for a short period but~     very early after discharge could be critical for optimizing care and improving early~     outcome.~      This study aims to compare such early intensive medical management with usual care in~     high-risk patients after discharge.~   "
94471|NCT01820767|"~     Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of~     inflammatory and oxidative stress parameters.~   "
94472|NCT01820754|"~     The purpose of this study is to evaluate whether the combination of neoadjuvant chemotherapy~     (chemotherapy before surgery) plus ipilimumab for lung cancer increases the number of~     patients with detectable circulating T cells with specificities against tumor associated~     antigens (TAA) from zero percent (0%) of patients prior to therapy to 20% of patients after~     neoadjuvant chemotherapy plus ipilimumab.~      This is an open label Phase 2 trial. Patients with clinical stage IB (>4 cm), II, (N0-2)~     non-small cell lung cancer (NSCLC) and no prior therapy for the current diagnosis of lung~     cancer will be eligible for the study. Subjects will receive 3 cycles of neoadjuvant~     chemotherapy (paclitaxel + cisplatin/carboplatin). Ipilimumab will be administered during~     Cycles 2 and 3 of standard chemotherapy and for up to 4 cycles alone after surgery. Subjects~     will undergo standard clinically indicated surgical resection of their lung cancer as deemed~     appropriate by their surgeon.~      Standard diagnostic and staging work up will be performed including: pathologic/histologic~     diagnosis of NSCLC, Positron Emission Tomography (PET)/Computed Tomography (CT) scan, brain~     imaging, and mediastinoscopy. Three cycles of neoadjuvant chemotherapy will be given.~     Ipilimumab will be added to neoadjuvant chemotherapy for cycles 2 and 3. Standard surgical~     evaluation and therapy will be performed following completion of neoadjuvant therapy. Two~     cycles of single agent ipilimumab will be given after surgery (adjuvantly), followed by 2~     cycles of maintenance therapy.~   "
94473|NCT01820728|"~     This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in~     treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene~     citrate treatment. The study is conducted with following methods: open label,~     active-controlled, randomized, parallel group, comparative.~   "
94474|NCT01820715|"~     A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is~     designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for~     Neuropathic pain.~   "
94475|NCT01820702|"~     Randomized cross-over design with 10 male subjects and 3 campaigns to test whether the~     negative effects of bed rest (6º head-down tilt) on the various systems of the body and the~     consequences to health of simulated weightlessness can be counteracted by the use of a~     defined training programme.~   "
94476|NCT01820689|"~     Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the~     post surgery period and correlate it with the time of palatoplasty. Methods: The sample~     consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public~     University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from~     three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.~   "
94477|NCT01820676|"~     This study is designed to monitor long term clinical outcomes of the iUni G2+~     unicompartmental knee replacement~   "
94481|NCT01820624|"~     This phase I trial studies the side effects and best dose of tretinoin when given together~     with lithium carbonate in treating patients with relapsed or refractory acute myeloid~     leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Tretinoin may help [type of cancer] cells become more like~     normal cells, and to grow and spread more slowly. Giving lithium carbonate together with~     tretinoin may kill more cancer cells~   "
94482|NCT01820611|"~     The primary purpose of this study is to evaluate the clinical performance of the Arcos~     Revision Stem system, determine the stability of the implants, and evaluate any relationship~     between Paprosky bone defect level and the success of the Arcos Stem.~   "
94483|NCT01820598|"~     The study was designed to test the following hypotheses:~      In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce~     higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase~     in muscle strength during stimulated contractions than conventional unidirectional~     electrostimulation session (c-NMES).~      In patients with severe obesity, a six-weeks m-NMES training program will enhance~     cardiovascular, metabolic and inflammatory parameters.~   "
94484|NCT01820585|"~     This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre,~     multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS).~     Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate~     (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as~     follows.~   "
94485|NCT01820572|"~     The primary purpose is to assess the benefits and risks of changing from Cyclosporine or~     Tacrolimus to Belatacept between 6-60 months after kidney transplant.~   "
94486|NCT01820559|"~     This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study~     to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic~     treatment in subjects with migraine with or without aura. Subjects were randomised in a~     1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.~   "
94487|NCT01820546|"~     In multiple myeloma cancer stem cells can be defined and quantified with flow cytometry.~     More, these cells can be related to treatment response.~   "
94488|NCT01820533|"~     To study ownership and use of cell phones in low-income smokers. This may help us better~     understand the impact of cell phone ownership plans on low income smokers' access to~     quitlines. Use of quitlines may be impeded by limited access to landline phones and limited~     airtime minutes on cell phones.~   "
94489|NCT01820520|"~     Study designed to evaluate the safety and efficacy of double staining with brilliant blue G~     0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or~     epiretinal membrane will be included. Safety will be evaluated by optic coherence~     tomography, pattern reversal electroretinogram and multifocal electroretinogram.~   "
94490|NCT01820507|"~     Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main~     reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of~     breathing. Most of this issues can be partly counterbalanced by a device named High flow~     conditioned oxygen therapy (HFCO). Then, our hypothesis is that HFCO may reduce the~     incidence of respiratory failure after extubation in patients with high risk for failure.~   "
94491|NCT01820494|"~     The study objective is to assess the growth of infants fed an experimental formula for the~     nutritional management of chronic diarrhea.~   "
94492|NCT01820481|"~     This clinical trial is designed to evaluate the efficacy, dose-response and safety of~     WIN-901X in Asthma patients.~   "
94493|NCT01820468|"~     This randomized controlled study tests an adapted critical time intervention model for~     veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on~     the inpatient unit who are assigned to such a community-based team will have shorter lengths~     of inpatient stay and better mental health. There have been few developments of~     community-based models of care in the post-deinstitutionalization era of short inpatient~     stays and the results of the study may inform how inpatient stays can be further reduced.~   "
94494|NCT01820455|"~     All trauma patients admitted to certain Intensive Care Units (ICU) will have~     Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA~     colonization status. Only those patients who are determined to be colonized with MRSA at~     admission will be included in the study. All patients must be age 18 and older, admitted~     directly to the ICU from either the Emergency Department or the operating room with~     trauma-related injuries, and must not have active or recent known history of MRSA~     infections. Once patients have been determined to be colonized with MRSA, they will be~     randomized to receive decolonization treatment or placebo. Decolonization treatment will~     include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will~     entail routine soap baths and Lubricating Jelly. Both groups will be kept on standard~     contact precautions throughout the course of the study. Repeat nasal swabs will be performed~     at the completion of the treatment regimen to determine the efficacy. Patients will be~     screened for invasive MRSA infections as dictated by their clinical course. The primary~     outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection,~     bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay,~     ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the~     end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75~     patients in each arm over the course of 12-24 months.~   "
94495|NCT01820234|"~     The purpose of this study is to determine the diagnostic and management concordance of~     face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer~     screening event.~      The investigators' hypotheses include the following:~        1. Compared to in-person assessment, store-and-forward teledermatology assessment will~          result in adequate diagnostic concordance.~        2. Compared to in-person assessment, store-and-forward teledermatology results in adequate~          management concordance.~        3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions~          that are either premalignant or malignant will be similar to that of in-person~          evaluation.~   "
94496|NCT01820221|"~     This is a randomized prospective clinical trial designed to determine the wound complication~     rates for stainless steel staples versus subcuticular suture for skin closure in the obese~     parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.~   "
94498|NCT01820195|"~     There are many controversies about the role of N-Acetyl Cystein in preventing of contrast~     nephropathy. These contradictory results may be due to different criteria for patients'~     selection, different end points, different type and dose of N-Acetyl Cystein administration~     and finally different prophylactic measures other than N-Acetyl Cystein. The investigators~     try to enroll a double blind double dummy study with a good power to compare the effect of~     this drug both in the form of oral and intravenous against the placebo in preventing the~     contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.~   "
94499|NCT01820182|"~     Comparative, randomized study patients are scheduled to have two capsule endoscopies within~     2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging,~     Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the~     devices are administered is randomly allocated.~   "
94500|NCT01820169|"~     This clinical study is to determine if the use of structured testing, which is a blood~     glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive~     effect on the subjects overall glycemic control.~   "
94501|NCT01820156|"~     Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as~     home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test~     probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making~     and costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with~     mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms.~      Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs.~     PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess~     concordance between the two different approaches were analyzed by sleep physicians and~     respiratory physicians (staff and residents) using agreement level and kappa coefficient.~     The costs of each diagnostic strategy were considered.~   "
94502|NCT01820143|"~     The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and~     compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1)~     and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg~     ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg,~     20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days;~     and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5~     following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg~     esomeprazole tablets for 5 consecutive days.~   "
94503|NCT01820130|"~     The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal~     Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter~     Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).~   "
94504|NCT01820117|"~     While thoracic radiation therapy (TRT) has been a primary component in successful treatment~     of a variety of childhood and adult cancers, the exposure to this treatment has been~     associated with significant cardiovascular and pulmonary morbidity in long-term survivors.~     Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with~     increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and~     neurocognitive impairment. Patients with chronic heart disease demonstrate problems with~     attention, processing speed, memory, and executive functions. Chronic pulmonary disease also~     increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in~     non-cancer populations. The investigators propose to examine indices of brain integrity,~     including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of~     Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system~     therapy.~      OBJECTIVES:~        1. To evaluate brain integrity in adult survivors of childhood HL treated with thoracic~          radiation therapy.~        2. To identify therapeutic factors associated with brain integrity in adult survivors of~          childhood HL who are at risk for cardiac and pulmonary morbidity.~        3. To examine associations between cardiac, vascular and pulmonary health and brain~          integrity in adult survivors of childhood HL treated with thoracic radiation.~   "
94505|NCT01820104|"~     Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump~     inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the~     hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this~     therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole,~     DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation~     in healthy subjects in oral glucose tolerance (OGTT).~   "
94506|NCT01820091|"~     To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related~     Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.~   "
94507|NCT01820078|"~     The purpose of this study is to estimate the differences between albuminuria values~     determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to~     last observation caused by paricalcitol between the group of control and group of treatment.~   "
94508|NCT01820065|"~     Although contemporary cataract surgery has made tremendous strides in technological~     advancement, posterior capsular opacification (PCO) is still the most frequent long-term~     complication leading to decreased visual functions and thereby dissatisfying results. A~     great deal of effort has been made to develop new ways to prevent the formation of PCO. A~     key factor, widely discussed in literature, is the material and design of the intraocular~     lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the~     sharp-edged IOL produces less PCO because of its optic geometry alone or whether the~     biomaterial contributes to the inhibition of PCO. With the clinical introduction of the~     single‐piece acrylic hydrophobic IOLs with some optic and haptic design differences compared~     with three‐piece acrylic hydrophobic IOLs, it has become possible to determine the influence~     of IOL material and design on PCO prevention. It is well established that the development of~     PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree~     of PCO. So far, there have been prospective clinical studies on the clinical results of~     single and three‐piece acrylic hydrophobic foldable IOLs. However, the question as to as to~     whether the PCO further increases or becomes stable or regresses on a long-term basis has~     not yet been answered. Since there is paucity of available literature that prospectively~     evaluates the development of PCO with the implantation of the single-piece SN60AT~     hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the~     degree of development of PCO at 5 years after cataract surgery.~   "
94509|NCT01820052|"~     Fibromyalgia (FM) is a disorder with chronic widespread musculoskeletal pain for which no~     alternative cause can be identified. The condition is often accompanied by other features~     such as fatigue, stiffness, cold intolerance, cognitive impairment, intolerance to external~     stimuli, sleep disturbances, anxiety and depression, which significantly affect the quality~     of life. Fibromyalgia is characterized by altered pain perception, and studies have shown~     fibromyalgia to be more prevalent in patients with iron deficiency anemia. Iron is essential~     for a number of enzymes involved in serotonin and dopamine synthesis. Deficiency of~     serotonergic neuronal functioning might be related to the pathophysiology of FM.~      This study attempts to explore the use of oral iron as a cheap and readily available~     alternative for the treatment of FM .~   "
94510|NCT01820039|"~     Objectives The investigators present an online application to empower and inform patients~     and improve guideline adherence in unexplained subfertility. Thereby the investigators~     expect to reduce overtreatment in fertility care with higher quality of care.~      Methods The investigators conduct a prospective cohort study including couples with a~     diagnosis of unexplained subfertility. Couples consulting their general practitioner with an~     unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online~     application, in which patients are asked questions about their fertility problem (ie~     menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis~     antibody titre and semen analysis). FertiScreen then uses the validated prediction model of~     Hunault to calculate couples' chance of natural conception during the next twelve months. In~     addition, patients can find links to extra information concerning subfertility. Couples can~     then initiate an online consultation with their general practitioner and a gynaecologist, in~     order to discuss their results and prognosis. When the calculated prognosis of spontaneous~     conception within one year is >30%, tailored expectant management for 6-12 months will be~     advised, as no benefit can be expected from fertility treatment.~      Questionnaires will be sent to patients as well as to their caregivers (general~     practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen~     (System Usability Scale) and the different domains of quality of care (effectiveness,~     cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the~     Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for~     Infertility.~      In order to be able to draw conclusions, the investigators will conduct a baseline~     measurement among couples with unexplained subfertility who have been referred to a~     fertility clinic. Their data will be abstracted from their medical records and they will~     receive the aforementioned questionnaires as well (except for the System Usability Scale).~      The investigators will recruit couples presenting to general practitioners in the Nijmegen~     area (which for second line treatment consists of one general hospital and one academic~     hospital). To detect an increase in guideline adherence of the current 60% to 75% with a~     power of 80% (P<0,05), the investigators need to include 152 couples in the before as well~     as in the after measurement.~   "
94511|NCT01820026|"~     Bacterial infections are a frequent complication in liver cirrhosis with a bad prognosis.~     However, the clinical outcome of cirrhotic patients with serious infections is significantly~     improved over the last 30 years due to early diagnosis and to the use of a more appropriate~     antibiotic therapy.~      As in the general population, empirical treatment should be initiated soon after diagnosis,~     after making the necessary sampling and should be based on the use of an antibiotic with low~     toxicity and broad spectrum antibacterial efficacy, taking into account the local~     epidemiology and prevalence of antibiotic resistance.~      The third generation cephalosporins are considered the gold standard in the treatment of~     most infections in cirrhotics due to their effectiveness against enterobacteriaceae and~     against non-enterococcal streptococci and due to their low toxicity.~      However, the recommendations for the antibiotic therapy are currently based on results of~     trials of '80s and '90s, when the proportion of resistant pathogens was lower. Similarly to~     nosocomial infections, the increasing rate of infections due to multidrug resistant (MDR)~     bacteria represents the rational for a different choice of empirical antibiotic therapy with~     a higher resistance barrier. This change in the epidemiology of community acquired~     infections is mainly due to the increased contacts with healthcare system of these patients~     and for the larger use of antibiotic prophylaxis. With this regard, it was recently proposed~     to introduce a third epidemiological class of infection Health care-associated: Infections~     occurring in community in patients who have been in contact with the health system shortly~     before the infection.~      This epidemiological class of infection should be distinguished from community-acquired~     because they are more similar tonosocomial in terms of their sensitivity to antibiotics.~     Therefore for this class should be taken into consideration the use of a different empirical~     antibiotic therapy.~      The investigators aim was to evaluate prospectively the effectiveness of a broad spectrum~     antibiotic treatment in a cohort of cirrhotic patients with~     healthcare-Associatedinfections~      Cirrhotic patients with Healthcare Associated admitted to the gastroenterology department~     of the Policlinico Umberto I and in the Department of Hepatology of the Hospital of Marino~     will be consecutively enrolled.~      Randomized controlled trial with randomisation stratified by epidemiological class of~     infection.~   "
94512|NCT01820013|"~     This blinded randomized comparative trial aims to determine the effectiveness of a~     customized Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in:~     a) reducing pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in~     pregnant women with PGP, c) improving quality of life for pregnant women with PGP d) cost~     effectiveness.~   "
94513|NCT01820000|"~     Use of MRI and DWI to diagnose cardiac scarring after heart attack.~   "
94514|NCT01819987|"~     About 17% of Chinese American preschool children are obese, compared to 12.4%of all children~     from age three to five years residing in the US; the prevalence of obesity is expected to~     increase in the future. Therefore, the proposed study will adapt a home-based and~     technology-centered childhood obesity prevention program for low-income Chinese American~     mothers of children three to five years old. The aims of the study are to assess the~     feasibility of the intervention and estimate the effect sizes on children's and mothers'~     outcomes.~   "
94515|NCT01819974|"~     The purpose of the study is to examine whether a stratified medication review performed in~     patients at highest risk of experiencing medication errors have impact on numbers of~     medication errrors during hospitalization.~   "
94516|NCT01819961|"~     The aim of this study is to assess the effect of postoperative parenteral fish oil on~     clinical outcome and immune function after major laparoscopic abdominal surgery.~   "
94517|NCT01819948|"~     The purpose of this study is to determine whether the administration of the PhytoMed™~     complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast~     cancer which has been completely surgically resected and without evidence of disease as~     determined by their physician~   "
94518|NCT01819935|"~     The purpose of this non-interventional, retrospective study of existing data is to evaluate~     clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based~     pneumonia by treatment and among subpopulations.~   "
94519|NCT01819922|"~     This study is designed to assess the effect of one single dose of PF-05175157 on metabolic~     and cardiopulmonary parameters before, during and after treadmill exercise in healthy~     volunteers.~   "
94520|NCT01819909|"~     There are very few level 1 or level 2 evidence studies that examine postoperative~     rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of~     level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009)~     that found only four studies that examined rotator cuff repair rehabilitation.~      The current study was performed to determine if there is a significant difference in passive~     glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular~     substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo~     rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins'~     exercises.~      Null Hypothesis: There will be no significant difference in passive range of motion, active~     range of motion, scapular substitution, and subject measured outcomes scores in subjects who~     undergo rotator cuff repair when treated with pulley exercises compared to Jackins'~     exercises.~   "
94521|NCT01819896|"~     Over the past year smartphones have developed from a niche product to a commoditized product~     and are now squeezing classic mobile phones out of market. According to a survey a quarter~     of the German population is making use of a smartphone at present.~      An interference between smartphones and the functionality of pacemakers or implantable~     defibrillators is rather unlikely but cannot entirely be excluded. A systematic study~     regarding a possible interference between smartphones and modern pacemaker- and ICD-system~     with a better shielding against external influence has not taken place so far. In this study~     the investigators intend to investigate any interference between different smartphones~     produced by different manufacturers and diverse cardiovascular implanted electronic devices.~   "
94522|NCT01819883|"~     This study investigates fat distribution in people with acromegaly. The investigator is also~     investigating the change of fat distribution before and after treatment of acromegaly. The~     investigator will compare the results of people with acromegaly to the results of healthy~     volunteers.~   "
94523|NCT01819870|"~     The purpose of this study is to compare the pharmacokinetic characteristics and safety of~     dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.~   "
94524|NCT01819857|"~     For many years droperidol has been used in prophylaxis and therapy of PONV. Information that~     it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those~     data didn't base on solid examinations confirming torsadogenic action of droperidol. It is~     known that droperidol prolongs time of repolarisation, but there wasn't any data confirming~     its impact on transmural dispersion of repolarisation. Only estimation both of those actions~     in one time allows to define for sure arrhythmogenic role of droperidol.~      The aim of this study was to answer the questions:~      6. Does droperidol make an significant prolongation of heart repolarisation, expressed as~     corrected QT interval?~        1. Does droperidol cause increase of transmural dispersion of repolarisation?~        2. Does possible torsadogenic acting of droperidol depend on dose of drug?~        3. Does ondansetron cause changes of electrical heart function, suggesting its~          possibilities to induce TdP tachycardia?~        4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV~          in people not suffering from cardiovascular diseases?~   "
94525|NCT01819844|"~     The purpose of this study is to test an experimental medical device designed to~     automatically control blood sugar. This device was designed for use by patients with~     diabetes while they are in the hospital, and others who may develop high blood sugar as a~     result of their medical problems.~   "
94526|NCT01819831|"~     When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming~     back. Radiation therapy is frequently used in addition to surgery to reduce the chances of~     the sarcoma coming back. However, radiation can have long-term side effects on the normal~     tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint~     stiffness.~      Recently, there have been advances in the way that radiation therapy can be given. Proton~     radiation therapy is one of those advances. With proton radiation, it is possible to give~     radiation over a smaller area surrounding the tumor, resulting in less radiation to the~     surrounding normal tissues.~      The purpose of this study is to determine whether proton radiation decreases the long-term~     side effects of radiation on normal tissues and if smaller proton radiation fields reduce~     local recurrence compared to the larger radiation fields that have been used in prior~     studies.~   "
94527|NCT01819818|"~     The purpose of this study is to evaluate the safety and tolerability of paliperidone~     palmitate over a 9-week period for participants with schizophrenia in Korea.~   "
94528|NCT01819805|"~     The purpose of this study is to evaluate the impact of extended release tramadol~     hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.~   "
94529|NCT01819792|"~     Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia)~     induction and consolidation chemotherapies related aplasia. The main aim of this study is to~     measure incidence of respiratory viral infections during AML induction and consolidation~     chemotherapy related aplasia. Primary end point is a positive polymerase chain~     reaction(PCR)associated with clinical signs.~   "
94530|NCT01819779|"~     The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and~     S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination~     formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a~     combination formulation of valsartan and S-amlodipine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
94531|NCT01819766|"~     This study aims to determine the performance of the Exact IBD-ACRN surveillance test to~     detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel~     disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of~     primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to~     participate in this study. Enrolled subjects will collect a stool sample for the Exact~     IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days~     prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of~     enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.~   "
94532|NCT01819753|"~     In this study 37 patients who had undergone percutaneous nephrolithotomy were included.~     Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans~     were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative~     month. A DMSA scan was read by using a technique that divides both kidneys into three paired~     poles. In this way functional changes were investigated in the renal units. Twenty six of 37~     cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple~     access sites. When each of the poles of a kidney was admitted as a surgical unit separately,~     there were 51 units.~   "
94533|NCT01819740|"~     The aim of our study is to determine if the levels of the HEM substance in seminal plasma~     are associated with the presence of prostate cancer in transrectal prostate biopsy.~   "
94610|NCT01818739|"~     This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph~     node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer~     staging and treatment.~   "
95115|NCT01812135|"~     A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and~     immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant~   "
94534|NCT01819727|"~     The BMN 165 clinical development program has been designed to demonstrate the safety and~     efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with~     hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized~     study designed to further characterize the safety of BMN 165 during two induction,~     titration, and maintenance dose regimens in adults with PKU who have not had previous~     exposure to BMN 165 (naive). Subjects will be randomized (1:1) to titrate up to one of two~     dose regimens. Other key features of this study are the dose regimens chosen for induction~     and titration; the study duration; self administration of study drug; and the chosen~     tertiary objectives.~   "
94535|NCT01819714|"~     The main objective of this study is to evaluate the effect of 3 months of Snoezelen-type~     multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for~     patients with Alzheimer's-type neurodegenerative disease.~   "
94536|NCT01819701|"~     Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme~     Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to~     investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation,~     antioxidant enzymes activities, and the inflammatory markers in coronary artery disease~     (CAD) patients. The study is designed as a three-year study. The first year is an~     observation study. We will recruit CAD patients who are identified by cardiac~     catheterization as having at least 50% stenosis of one major coronary artery, and age-gender~     matched healthy subjects. The concentrations of LC, coenzyme Q10, lipid peroxidation markers~     (TBARS and ox-LDL), antioxidant enzymes activities (catalase, glutathione peroxidase,~     glutathione reductase, and superoxide dismutase), and inflammatory markers are going to~     analysis. The second year is a single-blind, single dose intervention study. CAD subjects~     are recruit form the first year and randomly assigned to placebo, coenzyme Q10-150 (150~     mg/d), coenzyme Q10-300 (300 mg/d), LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups.~     Intervention is going to administration for three months. Fasting blood will be obtained in~     each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers,~     antioxidant enzymes activities, and inflammatory markers after intervention. The third year~     is a single-blind, multiple doses intervention study. We are going to measure the CAD~     subjects from the second year intervention study. After three months washout period, the~     subjects are assigned to placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus~     LC-2000, coenzyme Q10-300 plus LC-1000, and coenzyme Q10-300 plus LC-2000 groups.~     Intervention is going to administration for three months. Fasting blood will be obtained in~     each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers,~     antioxidant enzymes activities, and inflammatory markers after intervention. Hopefully, the~     results of this study could provide information of LC and coenzyme Q10 supplementation for~     clinical dietitian in advising CAD patients.~   "
94537|NCT01819688|"~     The purpose of this study is to determine whether the postoperative insulin resistance and~     cytokine release would be attenuated in laparoscopic compared with open liver resection.~   "
94538|NCT01819675|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this~     study) to its receptor using the special PET study.~   "
94539|NCT01819662|"~     Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people~     have a pacemaker, and each year another 36,000 receive them. All of these patients are~     usually seen yearly to have their device checked. However, pacemaker technology is now very~     reliable, batteries last well over 5 years, and many patients require their pacemaker only~     occasionally as a back-up. Each visit costs around £200 such that pacemaker follow-up cost~     the NHS around £50million per year. Most visits involve checking the battery and the leads~     which, in the absence of symptoms might be unnecessary.~      Pacemaker patients are at risk of developing other problems including heart failure which~     puts them at higher risk of hospitalisation and death. For those under follow-up, no~     mechanism exists to identify whether they might have heart failure, and for those receiving~     new implants, it is unclear which will go on to develop heart failure. Also, whether optimal~     heart failure treatment with a multidisciplinary team reduces the chances that they will be~     hospitalised is also unproven.~      Our study therefore has three main aims: 1) based on pacing indications and patient factors,~     to identify which patients are likely to develop complications and therefore which patients~     could be seen less frequently; 2) to validate and refine a simple risk score to help~     identify which patients in pacing clinic should undergo screening for heart failure; and 3)~     to establish whether such screening and subsequent optimisation of those with heart failure~     is clinically and cost-effective for reducing hospitalisation and death.~   "
94540|NCT01819649|"~     This is a pilot study proceeding an intended international trial.~      Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast~     tablets will reduce the risk of cancer in healthy individuals.~      Objective: The objective of this pilot study was to assess the viability of a full scale~     randomised trial.~   "
94541|NCT01819636|"~     The aim of the study is to assess the beneficial effect of the short term consumption of the~     highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low~     mineralized water.~   "
94542|NCT01819623|"~     Supervised nonpharmacologic therapy improve cognitive function in patients with Mild~     Cognitive Impairment~   "
94543|NCT01819610|"~     A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting~     in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be~     collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety~     and efficacy of SPRIX.~   "
94544|NCT01819597|"~     Stroke due to intracranial arterial atherosclerosis is a significant medical problem,~     carrying one of the highest rates of recurrent stroke despite best medical therapy, with~     annual recurrence rates as elevated as 25% in high risk groups.~      The goal of this investigation is to advance a promising surgical treatment for symptomatic~     atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The~     investigation will test in a phase II futility trial the potential of EDAS for further~     development before proceeding with the design of a definitive clinical trial of EDAS~     Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS).~      The investigation is a 4-year futility trial to test the hypothesis that EDAS~     revascularization combined with aggressive medical therapy warrants further evaluation in a~     subsequent pivotal trial as an alternative to aggressive medical management alone for~     preventing the primary endpoint of stroke or death in patients with symptomatic intracranial~     arterial stenosis (Specific Aim 1). During the investigation the time course of~     collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific~     Aim 2.~   "
94545|NCT01819584|"~     The purpose of this study is to continue follow up of conservatively treated CHI patients~     and to focus on their metabolic outcome, including frequency of hypoglycemia after~     discontinuing treatment and incidence of diabetes mellitus in the long term.~   "
94546|NCT01819571|"~     The investigators hypothesized that predictability of pulse pressure variation (PPV) on~     fluid responsiveness would be reduced in patients with coronary disease who have diastolic~     dysfunction.~   "
95898|NCT01801904|"~     The purpose of this study is to assess if panitumumab is active enough to warrant~     comparative studies in patients with metastatic colorectal cancer that has progressed after~     treatment with cetuximab.~   "
94547|NCT01819558|"~     Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent~     allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after~     reduced-intensity conditioning regimen.~      If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days~     after allograft.~      6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.~      The safety and immunological efficacy of this immune therapy after hematopoietic stem cells~     transplantation with reduced intensity conditioning will be evaluated.~   "
94548|NCT01819545|"~     The miRNA 107 gene is increasingly appreciated to serve key functions in humans. The miRNA~     regulate gene expression involved in cell division, metabolism, stress response, and~     angiogenesis in vertebrate species. But the relationship and diagnosis capability of miRNA~     107 and BACE1 mRNA gene expression in plasma and cerebrospinal fluid (CSF) of amnestic mild~     cognitive impairment (aMCI) and normal control is still a mystery.~   "
94549|NCT01819532|"~     Anemia in preterm neonates is a significant problem encountered frequently in the neonatal~     intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require~     at least one blood transfusion during their hospital course and many will require repeated~     transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections~     and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and~     placenta harbor up to 40% of blood available during fetal life. The current standard of care~     is immediate umbilical cord clamping. The investigators are performing a randomized~     controlled trial comparing immediate cord clamping to milking the umbilical cord prior to~     clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize~     that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping,~     without delaying neonatal resuscitation.~   "
94550|NCT01819519|"~     The purpose of this study is to develop a brief screening and behavioral intervention for~     the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic~     staff and feasible to implement as part of routine clinical prenatal care, and to test~     whether behavioral intervention for susceptible pregnant women can lead to a behavioral~     change that is likely to lead to decreased primary CMV infection. The study research~     assistants will enroll pregnant women who are less than 20 weeks' gestation, either English~     or Spanish-speaking and that do not have a primary CMV infection (never been infected or~     previously infected). Enrollment will occur during the woman's prenatal visit.~   "
94551|NCT01819506|"~     Each year in the US, approximately 795,000 people have a stroke, and the overwhelming~     majority of those who survive are unable to resume meaningful daily activities because of~     impaired movement in one arm/hand. This study will investigate the effects of a challenging~     4-week physical rehabilitation therapy program that is targeted at specific movement~     impairments and systematically progressed to assure an ongoing just right level of rigor.~     The investigators anticipate that therapy targeted to address specific movement impairments~     will improve recovery of arm/hand movement in people who have had a stroke.~   "
94552|NCT01819493|"~     In response to the growing threat of obesity on the health of American children,~     specifically African American children, the investigators propose to develop a program to~     educate and motivate African American families to improve health behavior for obesity~     reduction and diabetes prevention. This project will be unique in its partnership with local~     YMCAs and its use of Family Health Coaches from the YMCAs who will work one-on-one with~     participating families. The investigators feel this program will benefit all members of the~     families who are enrolled and will encourage all members to participate though the study~     will target one parent and one child who is 8 to 10 years old.~   "
94553|NCT01819480|"~     The purpose of this study is to learn more about the outcomes of treatment of throat and~     voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option~     involving the use of the da Vinci surgical robot to remove these cancers through the mouth.~   "
94554|NCT01819467|"~     The primary objective of this study is to determine whether the use of Seprafilm reduces the~     incidence rate of adhesion formation following a primary C-section.~      A secondary objective of the study will be to determine whether or not a correlation between~     the adhesion score and the difficulty or delay in delivery of the infant exists.~   "
94555|NCT01819454|"~     The aim of the project is to define the frequency with which EER is present in patient with~     chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring~     of the pH using the Restech system. This modern device is equipped with a narrow antimony~     probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The~     second aim is to determine the relation among EER, CHR and asthma bronchiale. We will~     compare the presence of reflux in three different patient groups (1. CHR without nasal~     polyposis, without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without~     asthma bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or~     ASA syndrome). We expect to find a significantly more frequent presence of EER in patients~     with CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will~     be especially these patients(with a difficult to manage nasal polyposis) benefiting from the~     antireflux therapy.~   "
94556|NCT01819441|"~     A. the controlling of the blood pressure, especially the variation of blood pressure, can~     slow down the development of the small vessel disease.~      B intensive BP control is more effective than normal control of blood pressure in slowing~     down the small vessel disease.~      C drugs of Calcium Channel Blocker(CCB) and Angiotensin-Converting Enzyme Inhibitor(ACEI)~     have no significant difference in lowing the blood pressure and variability of blood~     pressure~   "
94557|NCT01819428|"~     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the~     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line~     monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.~   "
94611|NCT01818726|"~     To evaluate Exjade efficacy and safety in patients with aplastic anemia and~     transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive~     treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment~     programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.~   "
95899|NCT01801891|"~     This study aims to determine if the use of surface neuromuscular electrical stimulation,~     applied to various motor points on the lower limb to elicit muscle contraction when combined~     with compression bandaging accelerates the rate of venous leg ulcer healing.~   "
94558|NCT01819415|"~     The purpose of this trial is to detect the influence of omega-3 supplements on vitreous~     levels of vascular endothelial growth factor (VEGF) in exudative age-related macular~     degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are~     randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula~     with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA~     and EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these~     patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines~     and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a~     potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition~     and metobolite levels will significantly vary according to VEGF levels. Based on the results~     of this pioneering clinical study, our research team will proceed to evaluate the individual~     anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites~     found.~   "
94559|NCT01819402|"~     Excess visceral fat is associated with chronic systemic inflammation and cardiovascular~     complications. Pioglitazone has been reported to variably influence visceral fat volume, but~     it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate~     the effect of pioglitazone on glucose metabolism of fat tissue by using~     18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)~     imaging.~   "
94560|NCT01819389|"~     The purpose of this study is to determine if low-dose imatinib and nilotinib combination,~     will improve treatment results in CML patients with failure, suboptimal response or~     intolerance to imatinib therapy.~      The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular~     response will be achieved in patients not previously obtained with imatinib monotherapy.~   "
94561|NCT01819376|"~     The purpose of this study is to determine if Facebook can be used as a motivating factor for~     obese or overweight adolescents in a weight-reduction program.~   "
94562|NCT01819363|"~     The objective of this study is to analyze the correlation between pleural elastance and the~     radiological effectiveness (measured by chest tomography) of pleurodesis performed via~     catheters in patients with RMPE. The secondary objectives of this study are: correlate~     pleural elastance with quality of life, analysis of dyspnea and pain after the procedure,~     clinical effectiveness, complications and mortality in 30 days.~   "
94563|NCT01819350|"~     The aims of this study were to determine the sucrose and liquid oral pediatric medicines of~     long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.~   "
94564|NCT01819337|"~     The aim of this study is to identify if there exists a correlation between the preoperative~     cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.~   "
94565|NCT01819324|"~     1. The purpose of the study is to test the effectiveness of a new mail-based intervention~          for breast cancer survivors compared with standard lifestyle management and~          no-treatment.~        2. This intervention addresses both lifestyle factors such as dietary and physical~          activities and psychological issues specific to breast cancer survivors to improve~          healthy behaviors.~   "
94566|NCT01819311|"~     This project will test Attention Bias Modification Training (ABMT) among children and~     adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for~     anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose~     of this project is to determine whether ABMT leads to reductions in anxiety and related~     impairment, relative to a placebo task condition.~   "
94567|NCT01819298|"~     Patients with COPD (chronic obstructive pulmonary disease) suffer from episodes of acute~     exacerbations leading to additional morbidity and mortality, and also a further decline in~     lung function. It has been well-established that bacterial colonization is prevalent in~     COPD, especially in moderate to severe COPD, and airway bacterial colonization is known to~     play an important role in the development of pneumonia and exacerbations. On the other way,~     inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) were recommended in the~     treatment of moderate to severe COPD. Though there were some evidences that ICS had some~     protective effects on airway mucosa against bacteria invasion, the locally immunosuppressive~     effects of ICS is still a concern. Indeed, the incidence of pneumonia was higher than the~     control group, not only in the Towards a Revolution in COPD Health (TORCH) study but also in~     various studies and meta-analyses.We hypothesized that airway bacteria colonization is~     associated with disease severity, and that disease status can be identified by CAT (COPD~     assessment test)scores and changes of CAT scores. We therefore conducted this prospective,~     observational study in which CAT scores and sputum cultures were assessed in moderate to~     severe COPD patients with the combination therapy of ICS and LABA every three months during~     the study period. The primary end-point is the condition of potential pathogenic~     microorganisms (PPM) colonization in view of CAT scores. The second end-point was the~     changes of PPM colonization in association with CAT changes during follow-up. By the mean of~     CAT follow-up, it could possibly provide a surrogate about the risk of exacerbation and~     pneumonia under the combination therapy of ICS and LABA.~   "
94568|NCT01819285|"~     Objectives~      I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival~     time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for~     local curative treatment who are randomly assigned to immediate vs. delayed endocrine~     intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).~      II. Compare the overall survival of these two groups of patients.~      III. Compare the time to first evidence of distant progression (N4 or M1) of these two~     treatment groups.~      IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these~     parameters following endocrine therapy.~      V. Study the prognosis of various sub-groups of patients stratified according to performance~     status, local tumor extent, nodal status, and choice of endocrine treatment.~   "
94569|NCT01819272|"~     This study compared the effect of delayed-release metformin (Met DR) to placebo and extended~     release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body~     weight, and assessed the safety and tolerability of a range of doses of Met DR when~     administered in subjects with type 2 diabetes mellitus (T2DM).~   "
95900|NCT01801878|"~     The aim of this study is to evaluate the skin quality of using adipose-drived stromal~     vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation~     system into irradiated breasts.~   "
94570|NCT01819259|"~     The overall goal of the proposed research is to evaluate the behavioral and genetic~     mechanisms of smoking risk in non-smoking young adults (aged 18-25 years of age) with and~     without ADHD using a novel laboratory-based model of intranasal nicotine administration.~      Study Hypotheses:~        1. that nicotine will produce greater positive and fewer negative/aversive subjective~          effects in individuals with ADHD. The study team also hypothesizes that nicotine will~          improve performance to a greater degree in those with ADHD.~        2. that individuals in the ADHD group will exhibit an increase in choices for nicotine vs.~          placebo in both conditions (i.e., main effect) and that this effect will be more~          pronounced in the High Demand vs. Low Demand conditions (i.e. Group x Condition~          interaction). Also that greater performance enhancing effects of nicotine will be~          associated with greater nicotine choice during the high demand cognitive condition.~        3. that the main effects of ADHD status on nicotine reinforcement will be heightened in~          the presence of certain genotypes. Also that the main effects of ADHD status on~          nicotine reinforcement will be heightened in the presence of certain genotypes. Finally~          that exposure to nicotine will alter epigenetic patterns in DNA~   "
94571|NCT01819246|"~     The overall aim is to reduce overall allogeneic transfusion requirements during cardiac~     surgery when compared to standard management.~      To evaluate this the investigators will test the hypothesis that intraoperative, autologous~     platelet apheresis will primarily avoid allogeneic platelet transfusion. Following induction~     of anesthesia and intravascular line insertion, the patient will be randomized to control or~     treatment arms by sealed envelope technique where computer generated, randomization numbers~     are assigned prior to enrollment based on study patient number which is never reused.~      The control arm will have central venous access sham connected to the apheresis machine~     Trima® (Terumo BCT, Denver CO); the treatment arm will be connected and undergo pheresis.~     The clinical team will be blinded by a sterile sheet acting as a curtain and a recorded~     playback of the typical sounds of the operation of the apheresis machine. At the end of the~     pheresis, the platelet units will be disguised with opaque coverings and agitated at room~     temperature in compliance with the American Association of Blood Banks (AABB)~     recommendations for platelet storage. On separation from CPB, the blinded administration of~     autologous platelets or allogeneic (blood bank) platelets will occur after protamine~     administration, if the surgeon requests platelet transfusion (this is typically the case for~     these operations). The surgeon will be blinded and he will order subsequent transfusions~     based on clinical evidence of microvascular bleeding in accordance with standard guidelines,~     as is the investigators practice for these operations.~   "
94572|NCT01819233|"~     This pilot clinical trial studies caloric restriction in patients with stage 0-I breast~     cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease~     progression in patients with breast cancer. Radiation therapy uses high energy x rays to~     kill tumor cells. Giving dietary intervention and radiation therapy together may kill more~     tumor cells.~   "
94573|NCT01819220|"~     Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior~     to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such,~     RAS inhibitors/calcium channel blockers are recommended as first line combination treatment~     for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium~     channel blockers are not well defined. This study will compare the efficacy of RAS~     inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose~     tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The~     primary endpoint will be that RAS inhibitors/calcium channel blockers will be more~     efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.~   "
94574|NCT01819207|"~     thromboelastography can identify alteration in the coagulation profile in bariatric patients~     who undergo sleeve gastrectomy or gastric bypass~   "
94575|NCT01819194|"~     This trial aims to establish a correlation between patient reported comfort while using soft~     contact lenses and meibomian gland dysfunction (MGD).~   "
94576|NCT01819181|"~     The study will evaluate all female patients with severe aortic stenosis undergoing~     transcatheter valve implantation with commercially available valves and delivery systems.~   "
94577|NCT01819168|"~     The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more~     effective in treating patients with nocturia.~   "
94578|NCT01819155|"~     This study will provide the Senegal Ministry of Health with data on the safety and~     immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose~     seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data~     will inform future policy considerations for influenza vaccine. The study is not powered to~     detect significant differences between vaccines or groups, and no hypotheses are to be~     tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.~   "
94579|NCT01819142|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will~     be treated using AutoloGel and standard care and case-matched against a concurrent cohort of~     patients receiving undefined Usual and Customary Care.~   "
94580|NCT01819129|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with~     insulin glargine and metformin in adults with type 2 diabetes.~   "
94581|NCT01819116|"~     The objective of this study is to quantify the association between tissue oxygen saturation~     (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ~     donor and the number of organs transplanted per donor.~   "
94582|NCT01819103|"~     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in~     England and develop recommendations for improving patient care.~   "
94583|NCT01819090|"~     Mechanical ventilation is one of the only treatment that has improved survival of patients~     with neuromuscular respiratory failure. As disease progresses, some patients may require~     longer ventilation period. Non invasive mechanical ventilation is the preferred method of~     ventilation but it may interfere with speech and communication of patients who require~     ventilation throughout the day. The investigators are evaluating the effect on speech and~     communication of a ventilation device which allows patients to momentarily and voluntarily~     withhold ventilation if they want to speak. This should allow the patients to have a more~     fluid speech.~   "
94584|NCT01819077|"~     TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in~     surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in~     high risk situations. More and more this therapeutic strategy is implemented in clinical~     routine in specialized cancer centres, thus, treatment of cervical cancer could be performed~     for these stages in a systematically defined and reproducible radicality; adjuvant~     radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource~     assignment in primary treatment dramatically. Due to the nerve-sparing character of the~     procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit~     the patient.~      This study is designed to follow up the results of this therapeutic concept adapted to~     clinical routine in a multiinstitutional register study accompanied by detailed assessment~     of pathological work-up, quality of life and bladder and sexual function following surgery.~   "
94585|NCT01819064|"~     An infants heart rate is very important because it ensures that blood is pumped to all~     organs in the body. Heart rate may decrease during anesthesia and surgery, and this is why~     the anesthesiologist will often give a medication to prevent this from happening. The most~     common drug for this purpose is called atropine. The dose of most drugs given to babies is~     based upon the baby's weight, but some believe that the dose of atropine should not be less~     than 0.1mg. However there is no evidence to support this minimum dose. A larger dose of~     atropine may cause a very fast heart rate instead. Anesthesiologists routinely dose the~     atropine based upon the baby's weight without regard for a minimum dose.~      The purpose of the present study is to measure the heart rate after doses of atropine in~     neonates and infants who receive less than 0.1 mg.~   "
94586|NCT01819051|"~     The purpose of this study is to evaluate the safety of treating human toenails with~     atmospheric plasma (MOE Antimicrobial Plasma Treatment System) and get an initial evaluation~     of the efficacy of this treatment for toenail fungus (onychomycosis).~   "
94587|NCT01819038|"~     This research project is a prospective study to compare mortality between early renal~     replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil~     gelatinase associated lipocalin (pNGAL) as a tool in decision- making.~   "
94588|NCT01819025|"~     The purpose of this study is to investigate whether face-to-face Cognitive Behavioral~     Therapy (CBT) with a smartphone application, focused on providing support in homework~     assignments and an increase in behavioral activation, is effective in treating mild to~     moderate depression. The study will be conducted as a randomized controlled treatment study~     investigating the effect of the current blended treatment compared to treatment as usual.~   "
94589|NCT01819012|"~     The purpose of this study is to determine Isoflurane's dose-dependent effect on left~     ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging~     (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane~     concentrations would be analyzed by using intraoperative transesophageal echocardiography~     (TEE) in cardiac surgery patients.~   "
94590|NCT01818999|"~     This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in~     combination with Ixabepilone for women with triple negative metastatic breast cancer.~   "
94591|NCT01818986|"~     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the~     stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites~     of bulky progressive disease, but also to provide antigen presentation and immune~     stimulation which is expected to act synergistically to the concurrently administered~     immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for~     metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR~     are FDA approved therapeutic cancer treatment~   "
94592|NCT01818973|"~     We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy~     and combination chemotherapy could results in improved pathologic tumor regression grade~     (TRG) in locally advanced nonmetastatic rectal cancer.~   "
94593|NCT01818960|"~     Revascularization strategies for ST elevation myocardial infarction (STEMI) study~     (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting~     multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on~     myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in~     patients presenting with STEMI and multivessel disease (MVD).~   "
94594|NCT01818947|"~     The purpose of this study is to understand real world gefitinib usage patterns, patient~     characteristics and outcomes and to present these for a Caucasian population~   "
94595|NCT01818934|"~     The aim of the randomized controlled trial was to determine whether the addition of a~     general or of a selective ultrasound screening program resulted in more appropriate criteria~     for treatment and a reduced prevalence of late DDH compared with clinical examination alone.~   "
94596|NCT01818921|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for~     certain doses of beloranib in obese subjects with Prader-Willi Syndrome.~   "
94597|NCT01818908|"~     The major purpose of this clinical study is to assess clinical outcome of dose-adjusted~     EPOCH regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic~     lymphohistiocytosis~   "
94598|NCT01818895|"~     The purpose of the study is to assess the dying process in critically ill patients with~     decision to withdraw invasive mechanical ventilation in anticipation of death and to compare~     effects of extubation and those of terminal weaning of mechanical ventilation on relatives~     and care givers. The investigators primary hypothesis is that extubation is associated with~     less symptoms of post-traumatic stress disorders in relatives, as compared to terminal~     weaning.~   "
94599|NCT01818882|"~     The main objective of our study is to compare the effects of two care strategies for~     dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis +~     conventional clinical chest radiography) versus (2) standard care + pleuropulmonary~     ultrasound.~   "
94600|NCT01818869|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending doses of AZD8848 in healthy subjects.~   "
94601|NCT01818856|"~     Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be~     affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two~     analogues (NRTIs) in HCV/HIV-co-infected patients.~   "
94603|NCT01818830|"~     The patients with sepsis are in the state of hypermetabolism, increased resting energy~     expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin~     resistance, hyperglycemia, and amino acid metabolism disorders. However, it is remain~     unclear the changes of amino acids expression profiling in sepsis patients. In this study,~     the investigators has planned to enroll 100 subjects, including 20 cases with systemic~     inflammatory response syndrome (SIRS), 20 cases with sepsis, 20 cases with severe sepsis and~     20 with septic shock. In addition, this study also include 20 normal cases as control. The~     serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first ICU~     admission. High-performance liquid chromatography and tandem mass spectrometry was used to~     detect the quantification of amino acids. The amino acids expression profiling contain~     Arginine, Ornithine, Histidine, Cystine, Isoleucine, Cystathionine, Leucine, Homocystine,~     Lysine, α-Amino-n-Butyric Acid, Methionine, Alanine, Phenylalanine, Anserine, Threonine,~     β-Alanine, Tryptophan, β-Amino-Isobutyric Acid, Valine, Carnosine, γ-Amino-n-Butyric Acid,~     Ethanolamine, Glycine, δ-Hydroxylysine, Serine, Hydroxy-L-Proline, Taurine,~     1-Methyl-L-Histidine, Tyrosine, 3-Methyl-L-Mistidine, α-Amino-Adipic, Phospho-Ethanolamine,~     Asparagine, Phospho-L-Serine, Aspartic acid, Proline, Citrulline, Sarcosine, Glutamic acid,~     Argininosuccinic Acid, Glutamine, Homocitrulline. The investigators speculate that~     measurement of amino acids expression profiling could be taken as an indicator for~     assessment in critically ill patients.~   "
94604|NCT01818817|"~     The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted~     paravertebral block with single shot is a safe and reliable anesthetic technique in breast~     surgery.~   "
94605|NCT01818804|"~     Background: There is evidence for a high cardiovascular risk in rheumatic and inflammatory~     diseases . Recent evidence suggest that psoriatic arthritis is also associated with an~     increased cardiovascular risk with accelerated atherosclerosis and increased cardiovascular~     risk. However, data regarding cardiovascular comorbidity and cardiovascular risk factors in~     patients with psoriatic arthritis are limited.~      Objective: The aim of this study is to investigate the effect of daily supplementation with~     3 g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and~     inflammation in patients with psoriatic arthritis.~      Design: Randomized double-blind, placebo-controlled, multicenter trial with n-3~     polyunsaturated fatty acids in patient with psoriatic arthritis.~      Setting: Departments of Rheumatology, Nephrology and Cardiology at Aalborg University~     Hospital and Vendsyssel Hospital in Region Northern Denmark~      Participants: 156 men and women aged > 18 years with psoriatic arthritis classified by the~     CASPAR criteria will be included. Exclusion criteria: cardiac arrhythmias, conduction~     disturbances, treatment with biological drugs or oral corticosteroids. Inclusion time:~     spring 2013 to spring 2015.~      Method: The following data will be collected for each participant: Interview including~     dietary records, assessment of tender and swollen joints, enthesitis, dactylitis, patient~     global assessment of disease activity (Visual Analogue Scale ), global assessment of pain~     (Visual Analogue Scale), psoriatic skin involvement by Psoriatic Area and Severity Index~     (PASI), laboratory parameters of disease activity and risk markers of cardiovascular~     disease.~      For detection of early cardiovascular risk markers Heart Rate Variability (HRV) and Pulse~     Wave Velocity (PWV) will be performed.~      Main outcome measures: The primary endpoint will be HRV and secondary endpoints will be PWV,~     inflammatory activity and use of analgesics.~      The trial is approved by The local Ethics Committee, registration number N20120076~   "
94606|NCT01818791|"~     As a nation, the U.S. invests heavily in community-based organizations to conduct~     interventions, proven through research, to reduce the high rates of unplanned pregnancies~     and sexually transmitted infections (STIs) and HIV among teens. Much less is invested in~     helping communities implement these programs with quality. Although many research-based~     programs exist to address teen pregnancy and STIs, communities face difficulty implementing~     them and achieving the same outcomes as researchers. This gap is because resources are~     limited, prevention is complex, and communities often lack the capacity—or the knowledge,~     attitudes, and skills—needed to implement off the shelf programs well. Common ways to~     bridge this gap, such as information dissemination, fail to change practice or outcomes at~     the local level in part because it does not sufficiently address capacity of community~     practitioners. Therefore, building a community's capacity is a method that could improve the~     quality of implementation and outcomes. The proposed study will use a randomized controlled~     design and primary data from middle school youth (960) and program staff from 32 cooperating~     Boys and Girls Clubs (Clubs) to assess how a capacity building intervention called Getting~     To Outcomes (GTO) augments the quality of implementation of a research-based intervention to~     improve teen sexual health (Making Proud Choices, MPC). Specifically, the study will: (1)~     Assess the utilization of and subsequent effects of GTO on program staff capacity to~     implement MPC; (2) Assess the degree to which Clubs using GTO show greater improvements in~     MPC fidelity than Clubs that are not using GTO; and (3) Assess the degree to which Clubs~     using GTO show greater improvements on teen sexual health outcomes than the comparison~     Clubs. To address these aims we will collect data on the delivery and utilization of GTO~     (e.g., method of delivery, duration, topics); staff capacity to implement research-based~     interventions; observations of program delivery (fidelity monitoring); and youth~     participants' sexual activity, pregnancy, STIs, condom use, and knowledge/ attitudes towards~     sex. Analyses will examine differences between intervention and control sites over time,~     accounting for clustering of youth within site. These outcomes are important to NICHD's~     focus on providing opportunities for youth to become healthy and productive adults.~   "
94607|NCT01818778|"~     Many volunteers visiting seniors make socially-based friendly visits. This study~     investigated the efficacy of volunteers making visits focused on stimulating cognition.~     Participants were randomly assigned to either a friendly visit control group or a~     cognitive stimulation group. Seniors receiving stimulation visits made statistically~     significant improvement in memory abilities.~   "
94608|NCT01818765|"~     Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the~     symptoms of selected patients with heart failure, and to reduce hospital admission and death~     rates in these patients. CRT can improve cardiac function by improving the coordination of~     the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of~     the veins running around the outside of the heart, to stimulate the outside of the left~     ventricle (main pumping chamber).~      There are two particular issues with this standard technique. In some patients it is not~     possible to get the wire into the coronary sinus due to difficult vein shapes, and in others~     the wire can be put there, but it does not end up in a suitable position to act on the heart~     enough to improve heart function. This is thought to be a major part of the reasons why one~     in four patients does not improve with CRT (non-responders).~      The investigators have developed a novel method of pacing the left ventricle of the heart by~     putting the wire through a tiny hole made in the muscle between the left and right~     ventricles and pacing the inside surface of the left ventricular chamber. This will allow~     patients in whom the coronary sinus cannot be used to have CRT. The investigators will also~     offer it to patients who have not improved with CRT, as there is evidence that they may~     respond to this procedure due to physiological benefits from pacing the inside rather than~     the outside and also the ability to steer the lead anywhere on the inner surface.~      The investigators have performed this new procedure in a small number of patients already.~     This study will allow closer follow-up of more patients, and also investigation of ways to~     optimize results of the procedure for these patients.~   "
94609|NCT01818752|"~     This is a Phase 3 multicenter, open-label, randomized study in transplant-ineligible~     subjects with newly diagnosed multiple myeloma. Subjects are randomized to receive 1 of 2~     treatment regimens: Carfilzomib, Melphalan and Prednisone (CMP) or Velcade® (Bortezomib),~     Melphalan and Prednisone (VMP).~   "
94612|NCT01818713|"~     Leptomeningeal metastases (LM) develop when tumor cells reach the cerebrospinal fluid (CSF)~     and infiltrate the leptomeninges. The median survival of patient with breast cancer and LM~     is 4-6 months with up to 25% long-term survivors. Many potentially highly efficacious~     intravenous chemotherapies are currently not effective to treat LM because they do not~     adequately cross the blood-CSF barrier.~      Doxorubicin, the anthracycline chemotherapeutic agent, has a well-established antineoplastic~     activity in breast cancer. To optimally enhance the delivery of liposomal doxorubicin to the~     brain, to-BBB technologies B.V. has designed a glutathione (GSH) pegylated liposomal~     doxorubicin hydrochloride formulation (2B3-101). Coating of liposomes with PEG ensures the~     prolonged circulation time in plasma, whilst conjugation of GSH to the tips of the PEG~     molecules targets the liposomes towards the active GSH transporters on the BBB to enhance~     the delivery of doxorubicin to the brain.~      This is a a clinical and pharmacological study that aims to determine preliminary efficacy~     of treatment with 2B3-101 in patients with leptomeningeal metastases of breast cancer using~     the LM response score.~   "
94613|NCT01818700|"~     The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of~     NORSPAN® from baseline.~      And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)~     the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's~     overall satisfaction, and safety~   "
94614|NCT01818687|"~     The objective of this study is to assess the safety and tolerability of colestilan (MCI-196)~     in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with~     hyperphosphataemia, who are not on dialysis.~   "
94615|NCT01818674|"~     The Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk~     Factor Control in Jordan spans 51 months and aims to test the effectiveness of the~     Microclinic Social Network Behavioral Health Program in influencing lifestyle behavioral~     risk factors to improve diabetes management that effect weight and metabolic outcomes~     through social networks. The Microclinic Social Network Behavioral Health Program provides~     microclinic (MC) groups—consisting of approximately 2-8 individuals from pre-existing social~     networks (friends, relatives, coworkers, neighbors, etc)—with shared access to diabetes~     education, technology, and group support to promote weight and metabolic control through~     diet, exercise, medication adherence, and blood pressure management. MC members play a role~     in the collective effort to combat diabetes and solidifying self-management behavioral~     skills through peer-monitoring and encouragement of lifestyle behaviors.~      This Microclinic Social Network Behavioral Health Trial was established in collaboration~     with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).~      This objective of the Microclinic Social Network Behavioral Health Trial, the first~     randomized control study of its kind, is to test the effectiveness of the Microclinic Social~     Network Behavioral Health Program. The study will yield valuable information on the impact~     of social relationships with diabetes education on weight and metabolic control among~     individuals with type 2 diabetes.~   "
94616|NCT01818661|"~     The study is designed to determine the relationship between structural and functional~     changes in the brain on imaging and progression of speech and language, neurological and~     neuropsychological features in patients with neurodegenerative apraxia of speech (AOS).~   "
94617|NCT01818648|"~     We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a~     glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable~     of inducing small bowel adaptation and regeneration in patients with short bowel syndrome~     (SBS), with the potential to decrease parenteral nutrition dependence.~   "
94618|NCT01818635|"~     The purpose of the study to investigate whether montelukast lead to behavior problems in~     children with asthma.~   "
94619|NCT01818622|"~     In this randomized controlled study we will investigate the effect of blue-blocking goggles~     or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to~     placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The~     main hypothesis is that virtual darkness therapy is effective as additive treatment in~     mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep,~     motor activity, circadian rhythm and mood also in the non-bipolar control-group.~   "
94620|NCT01818609|"~     Skeletal muscle mass declines with inactivity (casting is a good example) and increases with~     activity (such as weightlifting). Whether muscle mass increases or decreases, is determined~     by whether more new proteins within muscle are made than are broken down. The investigators~     know that feeding protein increases the synthesis of new proteins but that the response of~     older muscles to protein feeding is blunted compared with the young. This resistance of the~     elderly to muscle building stimuli may be the primary reason that muscle mass is lost in~     aging. The investigators also know that periods of muscle disuse such as casting result in a~     person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of~     new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at~     approximately 1% for every year after. Elderly persons would likely fare well with advancing~     age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually~     is a 'population view' and does not represent what occurs during short periods of muscle~     disuse (i.e. during hospitalization or illness), which occur with increasing frequency in~     elderly persons. During periods of disuse, the resistance of elderly muscles to protein~     nutrition may be worsened. The investigators will measure how quickly new proteins are made~     at rest and after protein feeding in elderly men, before and after a 14 day period of~     reduced activity brought on by having people reduce their daily step count.~   "
94621|NCT01818596|"~     This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and~     efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®;~     E/C/F/TAF) fixed-dose combination (FDC) tablet in treatment-naive and treatment-experienced~     HIV-positive, adult participants with mild to moderate renal impairment.~      The primary objective of this study is to evaluate the effect of E/C/F/TAF on renal~     parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA~     < 50 copies/mL will also be assessed.~      At sites able to conduct the appropriate testing, approximately 30 participants will be~     enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the~     PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate~     (TFV-DP).~   "
94622|NCT01818583|"~     Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract~     at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the~     general population. The prevalence of atrial fibrillation increases with age. Between 50 and~     70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal~     sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm.~     Another treatment option for conversion of atrial fibrillation and atrial flutter is~     electrical conversion. This is an effective treatment but requires anesthesia.~      Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter~     is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such~     converting drugs all have potentially serious side effects and are expensive. Potassium,~     sodium, calcium, and magnesium molecules are the most important ions causing electric~     current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial~     fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also~     hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal~     sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side~     effects.~   "
94623|NCT01818570|"~     The purpose of this trial is to evaluate the effect of a single PPC‐5650 dose in a human~     pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of~     the esophagus.~   "
94624|NCT01818557|"~     The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to~     test their blood glucose at least four times daily. The investigators propose to~     prospectively evaluate blood glucose testing done every day compared to every other day. The~     primary goal is to establish the most cost-effective modality while still being able to~     detect patients who require therapy in a timely fashion. The investigators plan to evaluate~     this new management scheme utilizing a non-inferiority trial design.~      The investigators primary research question is the following: When managing patients with~     GDM, is every other day blood glucose testing non-inferior compared to every day blood~     glucose testing, as measured by the difference of less than 5% in birth weight?~   "
94625|NCT01818544|"~     The primary objective of this study is to assess the safety and tolerability of 28 day oral~     administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).~      The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function,~     biomarkers of inflammation and tissue damage, and the impact on overall health and perceived~     well-being and to evaluate the pharmacokinetics of BAY85-8501.~   "
94626|NCT01818531|"~     This study will evaluate the affects of a single injection ultrasound-guided adductor canal~     block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental~     knee arthroplasty). Specifically, this study will compare the adequacy of postoperative~     analgesia provided by the adductor canal block with that provided by single injection lumbar~     plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal~     block will be equivalent to the analgesia provided by the lumbar plexus block. The primary~     outcome will be a comparison of verbal numerical pain scores at rest and with movement over~     the first 24 hours following nerve blockade.~   "
94627|NCT01818518|"~     To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered~     secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite~     neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS)~     (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary~     dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular~     hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood~     culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or~     death before neonatal hospital discharge.~   "
94628|NCT01818505|"~     Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease,~     but the exact mechanism remained to be elucidated. Many connective tissue diseases such as~     rheumatoid arthritis are often associated with antiphospholipid antibodies-associated~     endothelial impairment. In the present study, the investigators will analyze the presence of~     antiphospholipid antibodies in the serum of the patients with gout/asymptomatic~     hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia~     and gout. The investigators expect to find a correlation between these pathogenic antibody~     and those cardiovascular co-morbidities.~   "
94629|NCT01818492|"~     The purpose of this study is to assess the safety, tolerability and efficacy of a new drug~     aimed at controlling disease activity in patients diagnosed with primary haemophagocytic~     lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients~     not previously treated with the current standard of care, or can be given to patients who~     have either failed or were unable to tolerate the current standard of care. Administration~     will be on top of a glucocorticosteroid, which is usually part of the current recommended~     treatment.~   "
94630|NCT01818479|"~     Open label, dose finding trial with two treatment arms ( high-TBI and low-TBI conditioning~     regimens) to assess the efficacy of Treg/Tcon addback to CD34 selected partially matched~     related donor stem cells. The maximum tolerated dose will be established using 3 patients~     per dose level and there will be an expansion cohort at the MTD.~   "
94631|NCT01818466|"~     The aim of this study is to evaluate the clinical and radiographic outcomes of patients who~     have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate~     fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal~     tibia.~   "
94632|NCT01818453|"~     The goal of this project is to determine whether genetic information can be used to predict~     response to an internet-based treatment of depression. Several studies now indicate that~     completing an internet-based treatment for depression, called Deprexis, can significantly~     improve symptoms of depression. However, not everyone improves. The purpose of this study is~     to determine whether genetic profile can predict who is likely to improve.~   "
94673|NCT01817920|"~     Falls are very common accidents in Hospital. It not only results in injuries, less mobility~     among patients but increases their length of stay, cost and family burdens. Reducing the~     rates and injuries of falls is an urgent issue around hospitals.~      An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in~     CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of~     maintenance. The aim of this study is to determine whether IMFPP efforts support~     interventions with multiple components do reduce the fall rates and severity of injuries.~   "
94633|NCT01818440|"~     Background:~      - Researchers are interested in comparing two methods that doctors can use to position~     catheters in blood vessels. These methods are used to deliver chemotherapy and close the~     blood supply to a tumor. The methods are the standard method called fluoroscopy and a new~     way called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to~     help the doctor choose the best position for the catheter to get to the tumor. The computer~     shows the route on an x-ray screen in real time. This technique may help doctors position~     the catheter with less x-ray dye and in a shorter time. These methods will be compared in~     people who are having a procedure to destroy liver tumors. The procedure, called~     trans-arterial embolization, will deliver chemotherapy and destroy the tumor blood supply.~      Objectives:~      - To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor~     treatment.~      Eligibility:~      - Individuals at least 18 years of age who are having trans-arterial embolization for liver~     cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples, and have imaging studies.~        -  Participants will be divided into two groups. One group will have regular fluoroscopy~          (X-ray) during the procedure. The other group will have the procedure with the 3-D~          Roadmap software.~        -  In the first group, participants will have a CT scan. The doctor will decide how many~          vessels need to be treated. The doctor will advance the catheter using fluoroscopy~          only. Another CT scan will be given after the procedure.~        -  In the second group, participants will have a CT scan. The doctor will look at the scan~          with the 3-D Roadmap software. The software will show the path to advance the catheter.~          The doctor will use the software to help destroy the tumors. Another CT scan will be~          given after the procedure.~        -  Both groups will have the same follow-up care afterward. Other tests will be given as~          needed for the cancer treatment.~   "
94634|NCT01818427|"~     To determine the effect of the prehospital infusion during air transport of 2 units of AB~     plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional~     care.~   "
94635|NCT01818414|"~     Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and~     complications. Osmotic cervical dilators as well as prostaglandin analogues have been~     studied for cervical preparation. However, the optimal method for cervical preparation,~     especially for D&E procedures that occur on the same day as cervical preparation, is not~     known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for~     cervical preparation for same-day D&E between 16+0 and 20+6 weeks gestation.~      HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours~     prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative~     time for same-day D&E performed between 16+0 and 20+6 weeks.~   "
94636|NCT01818401|"~     Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10%~     yearly increase since the early 1990s. The clinical experience shows a strong rate of~     success on pain relief and on function. Longevity of the implants has been shown to be~     determined by the biomechanical design of the prosthesis, and by the implantation technique,~     especially the correct positioning of the bone cuts during the surgery. To improve the~     precision of these cuts, the patient matched cutting blocks developed by Medacta allow to~     adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A~     reduction of the surgery time lengh and bleeding would be other benefits expected with this~     type of ancillary. The objective of this trial is to study the reliability of patient~     matched cutting blocks for total knee arthroplasty, by both clinical and radiological~     assessment, the effect on morbidity reduction during and after the procedure and also the~     benefit it could bring on an economic point of view.~   "
94637|NCT01818388|"~     A multicenter prospective single arm interventional trial in hospitals where therapeutic~     hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability~     of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and~     reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.~   "
94638|NCT01818375|"~     Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and~     overall complications in patients undergoing abdominal surgery, there is a need to address~     the effect of implementing GDFT on the incidence of specific surgical complications and in a~     context of en enhanced recovery program (ERP). Specifically, studies investigating the~     impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic~     colorectal surgery and using an ERP are missing.~      It is hypothesized that the incidence of primary POI will be reduced in patients receiving~     intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after~     elective laparoscopic colorectal surgeries with an ERP program.~   "
94639|NCT01818362|"~     This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50.~     The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1~     and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison~     of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups~     will be recruited simultaneously to control for seasonal changes in influenza. This is~     because at certain times of year there is likely to be a higher naturally acquired T cell~     response to influenza than at other times due to circulating influenza virus in the~     community.~      The study has been extended to include 2 additional groups (group 5 & 6), each containing 12~     healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and~     group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.~   "
94640|NCT01818349|"~     Background: A discrepancy between strength gain and gait changes following various training~     programs aimed at improving gait function after stroke has been noted. A mismatch between~     the training program and gait parameters could explain this finding.~      Objective: To evaluate the impact of an isokinetic-strengthening program, matching the~     requirements of the affected lower-limb muscle groups involved in the energy generation of~     gait, to a control intervention, on gait performance and muscle strength.~      Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce~     greater changes in gait performance and strength than a control intervention not aiming at~     training these muscle groups.~      Design: Single-blinded randomized controlled trial.~      Participants: A convenient sample of 30 individuals with chronic hemiparesis.~      Interventions: Participants were randomly assigned into two groups (n=15), each training~     three times/week for six weeks. The experimental group trained the affected plantarflexors,~     hip flexors and extensors concentrically, while the control group trained the affected~     upper-limb muscles.~      Main outcome measures: Baseline values and post-training values, taken at the end of the~     training program, of maximal voluntary concentric strength, gait speed and peak positive~     power.~   "
94748|NCT01816945|"~     The investigators' mobile application-based community, termed Momba, will provide a~     bi-directional flow of information on maternal and infant mental health to traditionally~     underrepresented groups of mothers and their infants. The overall goal of this mobile~     application-based community of low-income postpartum women and infants is to increase the~     social support, social networks, and social capital of low-income mothers; thereby, leading~     to a positive change in the health behaviors, utilization of health services, and mental~     health status of both mothers and their infants.~   "
94641|NCT01818336|"~     A self- or parent-reported history of penicillin allergy excludes approximately 10% of the~     US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000,~     Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the~     penicillins can safely take these antibiotics without fear of a life-threatening reaction~     (Gadde et al. 1993, Macy et al. 1997). The outcomes of this erroneous classification of~     patients include unnecessary denial of an effective and well-tolerated class of antibiotics,~     which are often the treatment of choice.~      The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at~     very low risk of developing acute IgE-dependent reactions when given a penicillin or~     cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral~     challenge with a penicillin.~   "
94642|NCT01818323|"~     The overall goal of this study is to investigate the safety of T4 immunotherapy when~     administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck~     (SCCHN) that is not suitable for conventional active therapy.~      The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase~     I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells~     will be engineered to express a second generation chimeric antigen receptor (CAR) named~     T1E28z. Engineered T-cells will be injected directly into the tumour site. Patients will not~     be lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7~     through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is~     anticipated that up to 30 patients will be enrolled over the course of the study.~   "
94643|NCT01818310|"~     The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from~     bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity~     in patients with diabetes mellitus type II., intraarterially into the defect of the limb or~     with an intravenous application only, has a greater potential to improve the perfusion in~     the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find~     out differences among three different therapeutic types of BMAC application, to define their~     effectiveness and safety and to compare the impact of different means of application to the~     speed of healing of the limb defects and the improvement of perfusion parameters.~   "
94644|NCT01818297|"~     The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve~     Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of~     chronic, intractable post-surgical back pain in adults.~   "
94645|NCT01818284|"~     The goal of this clinical research study is to learn if treating stem cell donors with~     filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of~     blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of~     these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs~     to be performed.~      Researchers will study if using both drugs lowers the risk of the stem cell transplant~     recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in~     which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's~     body.~      The safety and effectiveness of this drug combination will also be studied.~      Filgrastim and plerixafor are both designed to help move or mobilize the stem cells from~     the bone marrow to the blood.~   "
94646|NCT01818271|"~     Stroke patients clearly benefit from intensive and coordinated inpatient care. While~     inpatient rehabilitation care is the preferred form for many patients post-stroke, due to~     access and financial barriers, many patients do not have this option. Community, outpatient~     rehabilitation programs will allow the patients with moderately disabling strokes the~     opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation ,~     while allowing some patients with mild disability to avoid inpatient rehabilitation~     completely.~      Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of~     treating adults who have suffered a single stroke using the following essential treatment~     components; a) community setting, b) group activity program, c) flexible, task-specific,~     computer-based exercise regime This program is designed to allow an extension of the~     in-patient rehabilitation experience to a community-based setting, in a cost-effective~     manner using paraprofessional staff and rehabilitation specialists, to provide a~     challenging, functional program to promote recovery and independence from physical~     impairments affecting balance and walking.~      The specific objectives are to:~        1. assess the benefits and feasibility of the multi-functional group exercise intervention~          for balance and mobility in a community setting. Secondary objectives~        2. identify effective combinations of exercises & activities that translate to increased~          abilities and participation levels.~      Hypothesis: Intense training targeting standing balance, and walking will significantly~     improve stroke clients' functional mobility. Training in a group setting and incorporating~     interactive and engaging computer gaming further provides the benefits of motivation and~     peer support while providing treatment in a cost effective manner.~   "
94647|NCT01818258|"~     HIV-infected children from sub-Saharan Africa often present with severe malnutrition. In~     severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate~     antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to~     weight ratio in severely malnourished children could also place them at higher risk of under~     dosing compared to children with mild to moderate malnutrition. However, limited data are~     available on the pharmacokinetics of ARVs in severely malnourished children. This study will~     address this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine~     (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children, compared to~     children with normal nutrition to mild malnutrition.~   "
94648|NCT01818245|"~     This study will include two groups (cohorts) of participants:~      In Group A, this study will look at the amount of LY2605541 that is present in the body~     after it is injected in 3 different locations in the body of the same participant. At least~     16 days will pass between each injection.~      In Group B, the study will look at how the body absorbs, distributes, and gets rid of~     LY2605541 in participants over age 65.~      Participants may enroll in only one group.~   "
94649|NCT01818232|"~     This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent~     of elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects~   "
94674|NCT01817907|"~     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.~     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an~     increased risk for developing high blood pressure. Currently, the best treatment for~     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose~     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the~     upper airway from closing in most people, many people have difficulty sleeping with the mask~     in place and therefore do not use the CPAP treatment. This research study is being conducted~     to learn whether using a sedative will improve OSA severity by altering some of the traits~     that are responsible for the disorder.~   "
94650|NCT01818219|"~     Due to recent technological improvements, it is now possible to record the electrical~     activity of the diaphragm (Eadi), a direct expression of the central nervous system~     respiratory center activity. By providing a relatively easy-to-use technique to record Eadi~     the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to~     explore the effects of various interventions on neural inspiratory activity in human~     subjects during spontaneous and assisted ventilation both for normal and simulated abnormal~     respiratory mechanics.~      The main aim of this project is to measure and compare the components of Eadi signal, the~     direct reflect of the respiratory centers activity, under various conditions of normal and~     simulated altered respiratory mechanics (either obstructive or restrictive respiratory~     mechanics° in order to better understand the neuroregulation of breathing. The second aim of~     the present project is to perform a similar analysis regarding the effects of various modes~     (Pressure Support and NAVA) and various levels of assisted ventilation both in case of~     normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and~     flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic~     derived parameters both during spontaneous breathing and assisted ventilation.~      Practically, by using the NAVA recording technology, the investigators will perform a~     physiological study on normal volunteers to explore the effects of normal and simulated~     abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and~     transdiaphragmatic pressures) in order to better understand the neuroregulation of~     breathing. Thirty healthy volunteers with documented normal lung function tests will be~     included in the study (obstructive respiratory mechanics will be simulated in 15 healthy~     volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).~   "
94651|NCT01818206|"~     Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been~     investigated in animals. The aim of the present study is to evaluate the efficacy of~     bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A~     cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic~     fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages~     strains in sputum samples collected. Then the sensitivity of individual colony will be~     tested.~   "
94652|NCT01818193|"~     A monocentric prospective open study to evaluate the frequency and nature of cognitive~     complications in the 3rd month post pulmonary transplant.~   "
94653|NCT01818180|"~     Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract~     infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).~   "
94654|NCT01818167|"~     The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10%~     benzoyl peroxide topical body wash for the treatment of early stage hidradenitis~     suppurativa.~   "
94655|NCT01818154|"~     The purpose of this study is to validate a new hand held light emitting diode (LED) device~     for the measurement of minimal erythema dose (MED) for narrow band Ultraviolet B (UVB)~     radiation by comparing to the traditional approach of measurement of the minimal erythema~     dose.~   "
94656|NCT01818141|"~     The purpose of this study is to compare number of vegetative cells and spores in stool over~     time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C.~     difficile infection.~   "
94657|NCT01818128|"~     The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided~     double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.~   "
94658|NCT01818115|"~     The objective of this study is to demonstrate the ability of the Hydrus Implant to lower~     intraocular pressure in glaucoma patients undergoing cataract surgery.~   "
94659|NCT01818102|"~     The purpose of this study is to investigate the appropriate window setting of chest computed~     tomography to select a correct size of double-lumen endobronchial tube.~   "
94660|NCT01818089|"~     The aim of this study is to investigate if any correlation between lung sounds of pneumonia~     patients and the clinical development or therapy of the pneumonia exists.~   "
94661|NCT01818076|"~     This study will evaluate the long-term safety of botulinum toxin type A for the treatment of~     moderate to severe crow's feet lines after repeat application.~   "
94662|NCT01818063|"~     This randomized phase II trial studies how well carboplatin and combination chemotherapy~     with or without veliparib works in treating patients with stage IIB-IIIC breast cancer.~     Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     giving carboplatin and combination chemotherapy are more effective with or without veliparib~     is more effective in treating breast cancer.~   "
94663|NCT01818050|"~     Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for~     resolution of biliary obstruction has been the method of choice for many years. However,~     stent clogging/obstruction is a major limitation in the management of biliary obstruction.~     Studies have shown that the conventional tubular type polyethylene stents (CS) with side~     holes accumulate significant sludge and their mean patency is approximately 90 days.~      Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3~     months.~      Recently, a stent with a star-shaped cross-section has been developed for biliary~     applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic~     biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of~     the stent. The stent which is star shaped in cross section, channels fluid along its winged~     perimeter. It has been proposed that the winged stent design with a lack of central lumen~     obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of~     multiple external drainage channels, is smaller. Longer term biliary drainage without the~     need for stent exchange should therefore be possible with these stents.~      The primary aim of this study is to prospectively evaluate the patency rate of the WS up to~     90 days in 50 patients with biliary obstruction due to stones or benign strictures.~   "
94664|NCT01818037|"~     Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.~      In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus,~     glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of~     cataract surgery.~      In our previous study, the investigators examined the intraoperative performance and~     postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients~     before their first birthday. At 1 year, the postoperative results showed that good visual~     outcomes could be obtained in microphthalmic eyes.~      Since only a few studies have reported outcomes, and that too only short term of cataract~     surgery on microphthalmic eyes, in this prospective observational study we evaluated the~     long-term impact of bilateral cataract surgery on eyes with microphthalmos. The~     investigators examined the outcomes, complication rates, influence of age at surgery on~     pattern of axial growth and central corneal thickness and visual and orthoptic assessment in~     these eyes.~   "
94675|NCT01817894|"~     Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six~     months after a period with six laser treatments for hair removal.~   "
94665|NCT01818024|"~     This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH)~     or intravenous (IV) routes in healthy subjects.~      Part 1 of this study will involve an initial assessment of safety, tolerability and~     pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a~     predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will~     occur which will assess key comparability criteria to inform progression to Part 2 of the~     study.~      Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or~     close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled~     routes of administration, in sequential manner, respectively. An interim data review will~     also occur after completion of Part 2, where all data accumulated previously will be~     assessed to examine appropriateness to progress to Part 3.~      Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous~     routes using the same dose administered in Part 2.~   "
94666|NCT01818011|"~     The primary objectives of this study are to assess the safety, tolerability and~     pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration.~     GSK1322322 shows broad spectrum antibacterial activity against pathogens involved in~     respiratory tract infections as well as methicillin-resistant S. Aureus (MRSA).~      This study consists of three parts (Part A, Part B and Part C). The results from Part A of~     this study will enable use of large-scale, commercial tablets produced for administration to~     patients in pivotal clinical trials of GSK1322322. The results from Parts B and C will~     support enrolment of Japanese subjects in future clinical studies. Additionally, the results~     will support the dose selection for further clinical development of GSK1322322 in~     hospitalized patients with severe bacterial infections in Japan and other Asian populations.~      In Part A, subjects will undergo screening, 4 treatment periods receiving single dose of~     each of: 1500 mg Initial, fit-for-purpose tablet (product code AP), 1500 mg Over granulated~     tablet (product code AR), and the 1500 mg and 2000 mg of intended commercial tablets~     (product code AU).~      In Part B of the study subjects will undergo screening, and be randomized to receive 3 doses~     of GSK1322322 oral cohort (100 mg, 1500 mg and 2000 mg) or IV cohort (600 mg, 900 mg and~     1200 mg) each in 3 treatment periods.~      Part C will be a single-blind, placebo-controlled, repeat dose study of GSK1322322 in~     healthy Japanese male subjects. GSK1322322 will be administered (fasted) via IV for 4 days~     BID, followed by administration of GSK1322322 orally (fed) for 6 days BID. A follow-up~     evaluation will be conducted 7-10 days following last dose of for each subjects in each Part~     of the study.~      Approximately 12 subjects will be enrolled in each part of the study such that approximately~     8, 6, and 9 subjects complete dosing and critical assessments in part A,B, and C~     respectively.~   "
94667|NCT01817998|"~     Background and study concept:~      Atrial fibrillation is the new global epidemic in cardiology. With improved survival from~     other cardiovascular diseases and longer living in general, the incidence and prevalence of~     AF rise dramatically in all developed countries with an estimated life time risk of one in~     four for all people above the age of 40 years. Similarly in Denmark, the prevalence is~     estimated to almost double within 2020. It is a fatal arrhythmia with doubled mortality~     compared to patients with normal sinus rhythm; this primarily caused by an increased risk of~     stroke and heart failure. In particular stroke is a feared complication with a 70% risk of~     fatal outcome or lasting handicaps and immense costs for each patient as well as in terms of~     health costs.~      Moreover, many AF patients experience a variety of symptoms and have markedly reduced~     quality of life. Opposed to heart failure patients and patients who have suffered from a~     myocardial infarction, AF patients are not offered any sort of rehabilitation when~     diagnosed.~      Pharmacological treatment of the arrhythmia is challenging. Most often, individual and~     careful risk evaluation including ultrasound of the heart is obligatory to choose optimal~     treatment strategy and prophylactic anticoagulation. In case a new anti-arrhythmic drug is~     started to restore and maintain sinus rhythm, hospitalization for at least two days with~     heart rhythm monitoring is required to detect any possible potentially dangerous or even~     fatal arrhythmia as a side effect to the treatment. Additionally, the first new oral~     anti-arrhythmic AF drug introduced for more than twenty-five years proved to be hazardous in~     a high-risk AF population and is now only used with strict precautions.~      To explore the role of alternative treatment strategies and to renew handling of cardiac~     arrhythmia, we have therefore set out to study the role of physical exercise in AF patients.~      Our specific study aims are to examine:~        1. The effect of physical exercise on AF burden~        2. The effect of physical exercise on the risk of cardiovascular hospitalization~      Method:~      Our study is an interventional, randomized exercise study. 60 patients older than 18 years~     with ECG-documented AF will be included if written informed consent is obtained. They will~     be randomized 1:1 to moderate-severe (80-85% of max capacity) or low intensity (50% of max~     capacity) training. Exclusion criteria are language barrier, illness inherent with an~     expected survival shorter than a year, other reasons preventing the patient from training,~     revealed serious cardiac disease during pre-tests, AF ablation within one year, permanent~     AF.~      Both groups are first participating in a nurse-led educational and care program. The program~     is built on two individual consultations and one team consultation with focus on education~     in AF.~      The patients will be thoroughly examined before randomization and after ended training~     period with special ultrasound of the heart, ECG-monitored test of maximal oxygen uptake on~     ergometer bicycle, 24 hours measurement of blood pressure and pulse, and blood samples. They~     will all be taught to use home ECG recorders, a new handheld device. The patients will send~     ECG's twice daily and if the experience cardiac symptoms for 5 months (during exercise and~     two months after).~      When randomized the patients will be divided in teams of ten and trained on separate teams,~     so the physiotherapist closely can guide the patients in training at the correct intensity~     level.~      Measurements:~      During and after physical exercise the burden of atrial fibrillation is measured by tele-ECG~     i.e. number of ECGs with atrial fibrillation divided by total number of ECGs. ECG reporting~     begins after four weeks of physical exercise and continues 2 months after last training~     session.~      Recording of hospitalization begins after randomization and continues one year after last~     training session. All hospitalizations caused by AF or related to the AF disease (relapse of~     AF, heart failure, stroke, new anti-arrhythmic medication, elective electrical~     cardioversion, complications to anticoagulation, pacemaker implantation) are recorded. Also,~     total days in hospital are registered.~      The AF population is growing on a global scale and the disease attracts immense interest on~     all international cardiology congresses. New knowledge of the effect of training for the~     general population as well as the effect in the setting of established disease could have~     paramount effect for prognosis, quality of life, and health costs as pharmacological~     treatment is AF still holds challenges.~   "
94668|NCT01817985|"~     This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the~     Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe~     hepatic impairment.~   "
94669|NCT01817972|"~     This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine)~     versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic~     Scoring in Crohn's Disease) score.~      It is a trial where the investigators are administering biological therapy by itself and~     biological therapy plus an immunosuppressive medicine in combination to see which form of~     therapy has a better effect on healing ulcerations in the small intestine and colon that are~     due to a flare up of Crohn's disease.~   "
94670|NCT01817959|"~     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear~     neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the~     first low molecular weight blocker of CXCL8 biological activity in clinical development.~     Thus, the use of reparixin may emerge as a potential key component in the sequentially~     integrated approach to immunomodulation and control of non specific inflammatory events~     surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D)~     patients.~   "
94671|NCT01817946|"~     Myotubular myopathy (XLMTM) is an X-linked disorder caused by mutations in the myotubularin~     gene (MTM1). The clinical spectrum is variable and ranges from individuals who require a~     wheelchair and full time breathing support to those who are able to walk and breathe on~     their own. Symptoms of myotubular myopathy include long faces, facial weakness with eye~     muscle weakness, breathing support with a muscle biopsy demonstrating central nucleated~     fibers. These symptoms may be caused by mutations or changes in the MTM1, BIN1 (bridging~     integrator 1), DNM2 (dynamin 2) and RYR1 (ryanodine receptor 1) genes. However, the majority~     are caused by mutations in the MTM1 gene. Some patients with symptoms consistent with~     myotubular myopathy who initially have negative testing of the MTM1 gene were later found to~     have a unique type of change in the MTM1 gene. This unique change, called a deletion or~     duplication, can be found with a different type of genetic test called a CGH (comparative~     genomic hybridization) array.~      Investigators do not know how frequent deletions and duplications are in patients with~     X-linked myotubular myopathy. Recently, there have been advances in identifying potential~     treatments for XLMTM. The next step will be to proceed with clinical trials of potential~     treatments. In order to be ready for clinical trials, it is important that investigators~     find the specific genetic change that is causing XLMTM in people with this diagnosis. This~     study will attempt to find changes in the MTM1 gene in individuals who have clinical~     symptoms consistent with a diagnosis of XLMTM. Participants will be asked to enroll in the~     CMDIR (Congenital Muscle Disease International Registry), complete a brief clinical survey,~     provide access to medical records, and provide a saliva or blood sample for genetic testing.~     Results of genetic testing will be communicated to participants by the physician specified~     in the consent by the signing person.~      Study Hypothesis:~      Not all individuals with a clinical diagnosis of XLMTM have access to genetic testing.~     Investigators know that deletions and duplications of the MTM1 gene can cause XLMTM.~     Investigators will find more individuals with XLMTM by performing genetic testing of the~     MTM1 gene, including CGH array for deletions and duplications.~   "
94672|NCT01817933|"~     The recovery of range of motion and muscle power after surgical intervention of the fracture~     will mostly affect patient's daily activities. So postoperative rehabilitation program will~     play the important role. Correct and effective physical therapy will reduce the functional~     impairment of limbs after long term casting or surgical fixation, and accelerate to recover~     the independent daily activities. There is no consensus between immediate or delay and the~     duration of continue physical therapy will improve the shoulder function、muscle power and~     degree of satisfaction( physiological function、social function、mental health、 pain、 general~     health status ) after surgical fixation of fractures. This study will evaluate the patients~     of the fracture that including of the humeral neck fracture, vertebral fracture, distal~     radial fracture and hip fractures after surgical fixation, to see the difference of fracture~     healing time, function recovery and pain sensation after intervention of physical therapy at~     different time point.~      From this study, we hope to discriminate the timing of intervention and duration of physical~     therapy which is the key factors for postoperative prognosis of fractures fixation, and to~     set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of~     this study will improve the discomfort of fracture patient's recovery or reduce the~     complications rate, and set up the standard treatment policy of our hospital , also was the~     model of other hospitals.~   "
94723|NCT01817270|"~     The purpose of this study is to observe the occurrence of adverse events, seroconversion~     rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.~   "
94724|NCT01817257|"~     This is a two year, multicentre, mixed methods feasibility study including a randomised~     controlled two-arm interventional trial, a nested qualitative study, focus groups and a~     United Kingdom (UK) wide survey exercise.~   "
94676|NCT01817881|"~     The purpose of this study is to determine whether temporal artery thermometers are accurate~     tools in temperature measurements of patients presenting to the Emergency Department. The~     investigators´ hypothesis is that there is a difference of > 0,3 degrees centigrade~     (Bland-Altman) between the temperatures measured with the temporal artery thermometers used~     at the investigators´ hospital (Exergen TAT-5000) and those measured with rectal~     thermometers (OMRON MC-341-E), which is considered to be the gold standard in Denmark~     defined by the Danish Center for Clinical Guidelines. The investigators furthermore~     hypothesize that the difference between these measurements is greater if measured in a~     patient with hyperthermia (temperature > 37,9 degrees Centigrade).~   "
94677|NCT01817868|"~     The project is an observational, multi-central, prospective, non-interventional and~     open-label data collection study on secondary prophylaxis with recombinant FVIII products in~     adolescents and adults with severe hemophilia A (FVIII < 1%).~      It will be a controlled observation of patients on secondary prophylaxis versus on-demand~     treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to~     prophylaxis and on-demand treatment.~      The patient enrollment period will be 2 years with a follow-up (observation period) of 2~     years for each patient. Based on the primary effectiveness parameters (joint bleeds and~     overall bleeds per year) an observation period of 2 years is considered sufficient although~     it has to be admitted that it is rather short to assess the progression of orthopedic~     status. Previously treated prophylaxis patients with at least 50 exposure days and patients~     with continuing prophylaxis treatment will be included.~   "
94678|NCT01817855|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic~     obstructive pulmonary disease.~   "
94679|NCT01817842|"~     This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline.~     The project will test the efficacy of a web-based system that uses mobile phones to improve~     quit rates at 3-month intervals, relative to standard quitline services. Under the standard~     model, relatively infrequent, periodic support is provided to smokers who want to quit and~     seek out the services. The new system will complement that effort by increasing the quality,~     frequency and accessibility of quit smoking support - when and where the smoker needs it~     most. It is hypothesized that successful abstinence rates will improve to the degree that~     participants utilize the support system and engage with the quitline.~   "
94680|NCT01817829|"~     It is a double blinded randomized control trial assessing the use of Oral paracetamol in~     managing the intrapartum pain.~   "
94681|NCT01817816|"~     Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in~     stroke patients. They cause disabled condition of patients in activities of daily life and~     functional performance, and also accidental falls and subsequent fractures.~      This study is to evaluate and compare the effects of different phase injection of Botulinum~     Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone,~     functional performance, gait pattern and energy consumption in stroke patients.~   "
94682|NCT01817803|"~     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart~     failure patients~   "
94683|NCT01817790|"~     This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular~     symptoms associated with allergic rhinitis (AR).~   "
94684|NCT01817777|"~     MTF116086 is an open-label, randomised, parallel-design study in subjects with type II~     diabetes. The study is site-based, with local pharmacies serving as the sites and~     pharmacists as principal investigators for the sites. All subjects will enter an initial~     8-week observational phase during which purchase behaviour and compliance with usual~     metformin use will be observed and recorded. At the end of the observational phase, subjects~     will be randomised to one of the two arms (metformin small pack vs. metformin large pack)~     for a 20-week interventional phase. The medication in the interventional phase is provided~     to the subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week~     8, and Week 28. Subjects will be asked questions about their tablet compliance, their~     satisfaction with the pack size they received and reasons for missing doses throughout the~     interventional phase by the pharmacist. The pharmacy visit on Week 28 will be end of the~     study.~   "
94685|NCT01817764|"~     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The~     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol~     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who~     meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the~     end of the run-in period, approximately 710 eligible subjects will be equally randomized (to~     complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1.~     UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning~     via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each~     morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC~     250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS +~     placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will~     be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if~     applicable). The total duration of subject participation will be approximately 15 weeks.~   "
94686|NCT01817751|"~     This phase II trial studies how well sorafenib tosylate, valproic acid, and sildenafil~     citrate works in treating patients with recurrent high-grade glioma. Sorafenib tosylate,~     valproic acid, and sildenafil citrate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
94687|NCT01817738|"~     The purpose of this study is to determine whether the new RNActive®-derived prostate cancer~     vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic~     metastatic prostate cancer that is castrate resistant.~   "
94749|NCT01816932|"~     This is a pilot study in which women who desire an etonogestrel implant will be randomized~     to either a home or office insertion visit. The purpose of this research is to study the~     interest in, feasibility of, and rates of insertion for implantable birth control~     (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office~     visit appointments.~      The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel~     implant and increase consistent and correct contraception use by introducing a previously~     unexplored method of access, the home visit.~   "
94688|NCT01817725|"~     Background:~      The HBsAg clearance rate in interferon-treated responders is significantly higher than that~     in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.~     There is a good chance to further increase the cure rate if the investigators can enhance~     the HBV-specific immune response when the HBsAg level already comes to a low level.~      Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients~     whose HBsAg already <=2000 IU/ml.~      Patients and methods:~      This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no~     hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine~     (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one~     year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each~     dose during the treatment period and every 3 months for another year following the last~     dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg~     clearance.~      Aims~        1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate~          chronic HBV infection in patients with low titer HBsAg.~        2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as~          to design a feasible schedule for future clinical trials in a larger group of patients.~        3. To discover viral and host factors which can be used as biomarkers for personalized~          vaccine therapy.~   "
94689|NCT01817712|"~     The primary objective of CSP#589 VIP-STAR is to evaluate the effectiveness of Individual~     Placement & Support (IPS) in unemployed Veterans with PTSD. The primary hypothesis is that,~     compared to those treated with transitional work program (TWP), unemployed Veterans with~     PTSD treated with IPS will be significantly more likely to become a steady worker. A steady~     worker is defined as holding a competitive job for greater than or equal to 50% of the~     18-month study follow-up period (i.e., greater than or equal to 39 of the 78 weeks). All~     participants will be followed for 18 months post-randomization.~      12/14/12: Analytic plan augmented to allow for a sensitivity analysis of the primary outcome~     that would exclude the first 12 weeks post-randomization, and evaluate between group~     proportion of steady worker status, as defined by working in a competitive job for greater~     than or equal to 50% of the weeks during week 13-78.~      7/1/13: Analysis plan has been augmented to include a logistic regression analysis of the~     primary outcome, adjusted for participating medical center.~      10/4/13: Addition of the IPS-25 Fidelity Scale. The addition of the IPS-25 scale should~     increase the validity of study results.~      1/15/15: Addition of an Interactive Voice Recognition/Web-based (IVR/Web) System; as an~     option for weekly data capture of the primary outcome data (employment history).~      8/17/15: Approval of Supplemental Data Collection at Participant Study Exit; use of the data~     collected will supplement the study analysis plan and, provide further insight into the~     impact of vocational rehab. A Participant Satisfaction Survey will allow study participants~     to indicate their level of satisfaction with the study, vocational rehabilitation~     intervention and, suggestions for future research.~   "
94690|NCT01817699|"~     The purpose of this study is to evaluate the effect of anemia correction and vitamin D~     supplementation in kidney transplant recipients.~   "
94691|NCT01817686|"~     Default options represent the events or conditions that are set into place if no~     alternatives are actively chosen. The setting of default options has well-established~     effects on a broad range of human decisions, but its influence on patients' preferences for~     end-of-life care is only beginning to be understood.~      This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness,~     assessing the impact of Advance Directive (AD) forms framed with different default options.~     The central goals are to assess how default options in ADs influence the end-of-life care~     choices made by patients at risk for critical care, and these patients' hospital and ICU~     utilization.~      The investigators hypothesize that setting defaults in real ADs will increase the proportion~     of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending~     therapies such as mechanical ventilation and dialysis, and reduce the proportion of time~     during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient~     satisfaction with end-of-life care planning.~   "
94692|NCT01817673|"~     There is a claim that creatine supplementation might affect kidney function, especially in~     those consuming a high-protein diet. The aim of this study was to investigate the effects of~     creatine supplementation on kidney function in resistance-trained individuals ingesting a~     high-protein diet.~   "
94693|NCT01817660|"~     Weakness in the wall of a blood vessel located behind the knee (popliteal artery) which~     leads to a swelling of this blood vessel (aneurysm) is one of the most common types of~     arterial aneurysms. It is associated with significant risk of blood clot formation,~     narrowing of blood vessel which can create a serious threat to individual's health.~     Currently, approved treatment options for this condition include both open surgical and~     endovascular stent-graft repairs.~      In the open repair procedure, the blood vessel behind the knee is tied up or removed and a~     small artery is created using a vein on the same leg. This is also called a bypass~     procedure.~      In the endovascular repair, using X-rays, doctors places a stent in the blood vessel. Stent~     is a small device similar to a thin tube. When it is placed in the right location, your~     doctor can open it. When stent is opened, it supports weakened blood vessel and blood goes~     through it. The weakened artery then shrinks around the stent.~      The OVER-PAR is a short name for this study. Many hospitals in the United States agreed to~     participate in this study. Patients are randomized to undergo either open or endovascular~     repair because they can be treated with either of the procedures. Investigators use the~     short names OPAR for open surgical repair and EPAR for endovascular repair. People who have~     an aneurysm that is larger than 2 cm (about an inch) can participate in this study.~      The purpose of this study is to compare outcomes after these two standard procedures.~   "
94694|NCT01817647|"~     Procalcitonin (PCT) is a biomarker used to monitor serious bacterial infections and guide~     antibiotic therapy. Anastomotic leak (AL) after colorectal surgery is a severe complication~     associated with relevant short and long-term sequelae. The aim of our study is to assess the~     predictive value of PCT level for early diagnosis of anastomotic leak after colorectal~     surgery.~   "
94774|NCT01816607|"~     The purpose of this study is to establish a reliable method for detection of rectal cancer~     patients with aggressive tumor at risk of metastatic disease and death by functional MRI.~   "
94695|NCT01817634|"~     New approaches are needed to prevent growth failure in children from low- and middle-income~     countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and~     energy content of complementary foods and have yielded only small to moderate effects on~     growth and development. There appears to be a missing link that mediates and reduces the~     expected beneficial effect. Child populations in LMIC show an asymptomatic environmental~     enteropathy that is characterized by a reduced size of the small intestinal villi, decreased~     gut integrity and a chronic inflammatory response in the gut. Results from studies in~     industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs)~     improve immune response and gut integrity. These reported beneficial effects could result in~     even more important physiological implications for children from LMIC and will ultimately~     contribute to their healthy growth and development.~      The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through~     complementary foods and human milk has an effect on infant growth and development in a~     context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify~     whether intake by either or both mother and infant is more effective.~      The specific objectives of the OME³Jim study are:~        1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food~          supplement on infant growth, morbidity, nutritional status and development;~        2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on~          infant growth, nutritional status and development;~        3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating~          mothers and infant on infant growth, morbidity, nutritional status and development:~        4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and~          human milk.~   "
94696|NCT01817621|"~     The purpose of this study is to develop and test counseling strategies for men who have sex~     with men (MSM) who are living with HIV and are experiencing body dissatisfaction.~      Two phases will be conducted throughout the course of the study.~      Phase 1: Develop an intervention for HIV-infected MSM that addresses body dissatisfaction~     and self-care. (NOTE: currently, only Phase 1 will be recruiting participants, Phase 2 will~     not be active for several months)~      Because of the prospective syndemic relationship between body dissatisfaction and~     depression, the investigator will integrate the most efficacious interventions for body~     dissatisfaction, depression, adherence, and sexual risk reduction, and tailor them to~     HIV-infected MSM. The investigator will then conduct an iterative process of pilots and exit~     interviews about feasibility, acceptability, and the strengths and weaknesses of the~     intervention until the intervention is maximized. Up to 9 participants will be involved in~     Phase 1.~      Phase 2: Conduct a two-arm randomized control trial comparing the newly developed~     intervention to a treatment-as-usual condition.~      As a first step in addressing the efficacy of the newly developed intervention, the~     investigator plans on randomizing up to 60 participants into either the newly-developed~     intervention or a treatment-as-usual condition. Participants will be assessed at baseline, 3~     months (acute outcome), and 6 months postrandomization. The primary outcome variable is body~     image disturbance. Depression, HIV sexual transmission risk behaviors, and highly active~     antiretroviral therapy (HAART) adherence will serve as secondary outcomes.~      Study hypotheses for the two phases include:~        1. The investigator will be able to develop and implement a feasible intervention that~          integrates addressing and relieving body dissatisfaction with increasing health related~          behavior change in MSM with HIV. Adequate recruitment (at least 80% of goal) and~          retention (at least 80% to follow up) in the trial will be an indicator of success for~          this aim.~        2. Those who receive the intervention will show improvements in health behavior outcomes~          (medication adherence, HIV transmission risk behavior) and will show reduced body~          dissatisfaction and depressive symptoms.~   "
94697|NCT01817608|"~     The investigators objective is to assess quality of life and functional outcome in patients~     requiring short-term mechanical ventilation. Additionally, the investigators plan to measure~     the recovery of peripheral muscle strength and respiratory muscle strength during recovery.~   "
94698|NCT01817595|"~     Background~      With the emergence of the internet, health care professionals are changing the way they~     approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at~     keeping blood glucose levels normal or in the range of acceptable levels to prevent the~     complications associated with diabetes. The Principal Investigators have completed a~     randomized clinical trial supporting the efficacy of IBGMS (1,2).~      Patient satisfaction of reporting platform is essential to encourage patient reporting and~     participation in IBGMS. In this study, we wish to compare two different types of meters~     which will be used to internet blood glucose monitoring: the BG Star Meter (Conventional~     Meter), and the iBG Star Group (iPhone Technology).~      Purpose and Rationale~      Patients who are more satisfied with their meter and internet reporting platform are more~     likely to participate in an internet monitoring system. Patients often lack the motivation~     to report to their endocrinologist. With increased reporting to their healthcare~     professional, patients are more likely to benefit from such a system. This study aims to~     compare two types of meters and their respective internet reporting platforms to encourage~     patient participation.~      Objectives~      Our main goal is to compare the two types of meters.~      Primary Outcomes Include:~        1. Patient Satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire~          (DTSQ)~        2. Frequency of reporting to endocrinologist~        3. Number of Self-Monitoring Blood Glucose (SMBG) tests~        4. Time taken to teach each patient the platforms~      Research Design/Methods~      Sample Size: 50 patients will be randomized into two groups:~      BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in~     which patients will upload their readings onto a computer and send in their readings via~     email.~      IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will~     upload their readings to their iPhone and send in their readings using the iPhone.~      Patients will be recruited from a Physician's private office.~      Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked~     to perform SMBG 3 or more times per day and to upload their metered glucose values online~     every 2 weeks to be reviewed by the doctor.~      Inclusion criteria:~        -  Type 1s~        -  Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.~        -  Willingness to test blood glucose levels a minimum of 3 times daily~        -  Willingness to be randomized~        -  Trained in self-blood glucose monitoring~        -  Internet Access~      Exclusion criteria: Patients who do not meet the above criteria or are not willing to~     participate will not be included in the study.~   "
94699|NCT01817582|"~     This study is being conducted to investigate the safety, comfort, and tolerability of 3~     treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without Restasis 0.05%~     administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety~     visit 1 week post-treatment. This study will also investigate the relative efficacy of~     Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID~     and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of~     keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week Treatment Period and at~     the end of a 12-week Treatment Period.~   "
94700|NCT01817569|"~     The purpose of this investigation is to describe general safety profile of type II Diabetes~     Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices.~   "
94701|NCT01817556|"~     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group~     clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients~     with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three~     times a day for four weeks.~   "
94702|NCT01817543|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be~     treated using AutoloGel and case-matched against a concurrent cohort of patients receiving~     undefined Usual and Customary Care (UCC)~   "
94703|NCT01817530|"~     This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety~     and efficacy of elagolix alone and in combination with add-back therapy versus placebo on~     heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.~   "
94704|NCT01817517|"~     This research is being performed to try to understand if the use of deep brain stimulation~     or DBS can treat the symptoms of Tourette syndrome that do not respond well to current~     medications. In order to do this the investigators will place small stimulation leads on~     both sides of the brain in a region (a portion of the thalamus) that may alter the abnormal~     activity in the brain contributing to the symptoms of Tourette syndrome. This requires two~     surgical procedures, and several preoperative and postoperative visits for tuning the~     stimulation parameters and recording stimulation effects. The FDA has not approved DBS for~     use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not~     conducted testing for the system in Tourette syndrome. Therefore its use in this study is~     experimental.~   "
94705|NCT01817504|"~     Our hypothesis is early and systematic transplantectomy under a well-conducted~     immunosuppression is associated with a decreased risk of anti-HLA immunization against a~     conservative attitude including a gradual reduction of immunosuppression, with or without a~     transplantectomy performed for cause (clinical event).~      Observation or Investigation Method Used :~      The study is :~        -  multicenter~        -  prospective~        -  open~        -  randomized: patients are divided into two parallel groups:~             -  study group: transplantectomy within six weeks after return to dialysis,~               antiproliferatives stop at the start of dialysis, Maintenance~               anticalcineurin-based-immunosuppression without dose reduction up to two weeks~               after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after~               transplantectomy. Corticosteroids: 5mg per day until one month after~               transplantectomy then stop within one month.~             -  control group: No systematic transplantectomy. Antiproliferatives stop at the~               start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and~               then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop~               within 3 months.~      In the case of transplantectomy for cause in the control group, immunosuppression will be~     continued at the maintenance dose during the current surgical procedure, and withdrawn two~     weeks later,similary to systematic transplantectomy.~   "
94706|NCT01817491|"~     The purpose of this study is to investigate the short-term effects of a reduced fat~     plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk.~     This plant-based diet consists of whole grains, fruits and vegetables and little amounts of~     nuts and seeds, with no limitations on the amount of food intake. Animal products are not~     allowed. The results of the plant-based diet will be compared with the diet recommended by~     American Heart Association. This diet also emphasizes fruits and vegetables, but allows~     healthy fats, low-fat meats, fish and low-fat dairy in moderation. The results of the study~     might be useful in understanding whether or not plant-based diets are protective against~     cardiovascular disease.~   "
94707|NCT01817478|"~     The investigators want to find out if there is any difference between the microbiotic flora~     lining the conjunctiva of medical staff that work in the hospital and others who do not work~     in the hospital.~   "
94708|NCT01817465|"~     This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in~     treatment of the patients with functional dyspepsia. The study is conducted with following~     methods: multi-centers, double blind, randomization, parallel. The subjects will receive~     Motilitone® or/and Pantoline®.~   "
94709|NCT01817452|"~     Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without~     chemotherapy backbone within the ADAPT trial.~   "
94710|NCT01817439|"~     Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity.~     Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at~     high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention,~     delay in treatment, and prolonged hospitalization. Therefore, examining new therapy~     approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research~     goal.~      Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the~     treatment of AF of recent onset (duration < 48 h).~   "
94711|NCT01817426|"~     The purpose of this study is to determine whether infliximab can favourably and safely be~     discontinued in patients with Crohn's disease in sustained complete clinical, biochemical,~     and endoscopic remission on infliximab.~      Further to examine the clinical utility of measuring levels/activity of infliximab and~     activity of anti-infliximab Ab in patients in sustained complete remission, in order to~     investigate whether pharmacoimmunological data can predict the clinical outcome and~     rationalize therapeutic management of these patients with respect to continuation or~     discontinuation of infliximab therapy. Additional, to investigate the optimal time-point,~     out of three, to measure this activity.~   "
94712|NCT01817413|"~     Children often damage their front teeth. In approximately 6% of cases, the nerve inside the~     affected tooth dies (becomes 'non-vital') and natural root development stops. In these~     cases, the tooth requires a root canal treatment in order to prevent problems such as pain~     and dental abscesses from arising. However, because the roots of these young teeth are not~     fully formed, they are weaker and prone to fracture. In addition, root canal treatment is~     difficult because a root canal filling cannot be placed in a tooth which is not yet fully~     formed, due to the fact that the root has an 'open' end.~      To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of~     the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral~     Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the~     tooth. However, although they help to provide a barrier, they do not help to strengthen the~     walls of the root. Treatment with these materials requires multiple visits to the dentist,~     over a period of up to 18 months.~      There is evidence to suggest that an alternative treatment involving 'revascularisation'~     (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows~     'natural' root growth to restart, and also strengthens the walls of the root. Treatment can~     often be carried out in just two visits.~      The aim of this study is to discover whether there is a difference between one of two~     methods of treating non-vital teeth with open ends. It is thought that there will be no~     significant differences seen between the results of the two techniques.~      Children with teeth that fall into this category and require root canal treatment will be~     given one of two treatments, both of which aim to treat infection, close the root end and to~     allow healing to take place.~      Teeth will receive one of the following methods of root treatment:~        1. Revascularisation (recovery of the natural blood supply to the tooth) following~          placement of an antibiotic paste into the tooth root. The aim of this treatment is to~          allow 'natural' root growth to restart. Root growth will allow the tooth to form at~          barrier at the end of the root. No root canal filling will then be necessary.~        2. Closure of the open root end by placement of an artificial barrier at the end of the~          root so that a root canal filling can then be placed. This will be done with a dental~          material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are~          routinely treated in this way at Liverpool Dental Hospital.~   "
94713|NCT01817400|"~     The study is seeking to understand how being overweight and obese makes women less fertile.~     The studies the investigators have done so far indicate that there is a hormone or other~     substance produced by fat that goes into the blood and reduces reproductive hormones in~     women who are overweight and obese. The present study will try to find the most promising~     substances by studying small numbers of women and trying to remove the substances that are~     causing the problem.~      Hypothesis: A circulating factor or factors, either hormonal, inflammatory or metabolic,~     causes relative pituitary hypofunction and correction of this reproductive deficit will~     allow obese women with infertility who have failed to reduce their body weight to normal to~     conceive, and may also prevent the horizontal passage of an adverse metabolic phenotype to~     the offspring.~   "
94775|NCT01816594|"~     This randomized, parallel cohort, two stage, double-blind, placebo-controlled study will~     evaluate the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in~     HER2-positive primary breast cancer prior to definitive surgery (neo-adjuvant setting).~   "
95901|NCT01801865|"~     The purpose of the present study is to make medically indicated state of the art/high end~     magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's~     Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).~   "
94714|NCT01817387|"~     This project will result in the development of a personalized intervention strategy to~     improve motivation for treatment engagement and functional outcomes in individuals with a~     recent onset of schizophrenia. Motivational impairment is arguably the single most important~     factor that determines a patient's ability to engage in and adhere to effective treatment.~     In our study, sixty participants will be enrolled in a randomized controlled trial comparing~     the feasibility and tolerability of two types of motivational interventions (Daily Goals or~     PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized~     to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also~     receive an 8-week course of cognitive training delivered via iPads. Participants will~     undergo pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of~     the interventions. By enhancing motivation, schizophrenia patients would be able to engage~     more fully with treatment and develop full and productive lives. This study may also pave~     the way forward for other health conditions in which motivational impairments impede health~     outcomes.~      All assessments will be conducted at the University of California, San Francisco; however,~     we offer some assessments to be done remotely.~   "
94715|NCT01817374|"~     1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to~          neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale~          ultrasound and post-treatment mammography findings utilizing final surgical pathology~          and clinical outcome.~        2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion~          measurements and enhancement patterns in predicting tumor response to adjuvant~          treatment in clinical studies.~      The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound~     (echocardiography) of the heart. Definity® will be used off-label (during ultrasound of~     the breast) in this study. The administration of Definity® during this study will follow~     total dose guidelines approved by the FDA.~   "
94716|NCT01817361|"~     The public health impact of this study will be the application of the greater understanding~     of the oral health status, oral health related behaviors, and quality of life of patients~     with systemic sclerosis (scleroderma or SSc). It is hoped that risks and protective factors~     can be identified to be associated with the oral health status of adults with systemic~     sclerosis,leading to the development of interventions for improved oral health in this~     population,and providing the basis for a larger study of oral health problems of adults with~     systemic sclerosis.~   "
94717|NCT01817348|"~     1. Therapeutic exercise, especially stretch exercise and joint mobilization, remain the~          mainstay of conservative treatment of frozen shoulder.~             1. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.~             2. Manipulation or arthroscopic release under general anesthesia may avoid pain~               during the intervention; however, increased risk of humeral shaft fracture and~               failure of release of pathological tissue were reported.~        2. We consider intra-articular injection is a compromized way, from a practical point of~          veiw, to reduce the pain during physiotherapy.~        3. We hypothesize that, intra-articular injection with lidocaine before joint mobilization~          and stretch exercise, can make the patient pain-free during physiotherapy, and the~          effect of combined therapy is superior to physiotherapy alone in the treatment of~          frozen shoulder.~   "
94718|NCT01817335|"~     This pilot clinical trial studies psycho-educational program in increasing knowledge and~     satisfaction and decreasing distress in younger patients with cancer receiving treatment.~     Psycho-educational program may increase knowledge and satisfaction and decrease distress in~     younger patients with cancer receiving treatment~   "
94719|NCT01817322|"~     To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of~     Enteric-Coated Mycophenolate Sodium would preserve renal graft function after~     transplantation without an increase of incidences of adverse events, such as biopsy~     confirmed acute rejection, local or systemic infections, and bone marrow suppression.~   "
94720|NCT01817309|"~     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in~     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent~     peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing~     peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that~     bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids~     such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body~     fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor~     of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with~     PD peritonitis. After inform consent, specimens of PD effluent will be collected on the day~     of initiating antibiotic treatment, every 5 days until the day of completing antibiotic~     treatment, and then 28 days later for the test of LPS level. All patients will be followed~     for one year after completion of antibiotic therapy for the development of relapsing,~     recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS~     in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.~   "
94721|NCT01817296|"~     Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men.~     It appears scar tissue forms in these boys' testicles, leading to progressive destruction~     over their lifetimes. Advanced reproductive technology can be used to surgically retrieve~     sperm from these individuals, but these methods have a 50% failure rate in adult Klinefelter~     patients. Younger men have higher success rates, suggesting that adolescence and young~     adulthood may be the best time to extract sperm, but these techniques have not been studied~     in Klinefelter patients younger than 26 years of age. Additionally, there is currently no~     way to predict which Klinefelter patients will have success with these methods and which of~     them will not. This trial will explore sperm extraction in Klinefelter syndrome in an age~     range (12-25 years) that has never been studied, with the ultimate hope of improving the~     potential for fertility in these patients. The specific goals of this study are to determine~     the ideal age for sperm retrieval in Klinefelter patients and to establish factors that can~     be used to predict which of these patients will have a higher likelihood of success with~     advanced reproductive technology. The hypothesis is that younger Klinefelter patients will~     have higher sperm retrieval rates.~   "
94722|NCT01817283|"~     This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to~     evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation~     biomarkers in HIV-infected immunological non-responders.~   "
94725|NCT01817244|"~     Suicide is a significant cause of death in Korea. According to the report compiled by the~     Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National~     Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in~     the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and~     Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons~     who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression~     when they committed suicide. Therefore, this study aimed the impact of a care management~     intervention on depression treatment and reducing suicidal ideation in elderly patients with~     depression.~   "
94726|NCT01817231|"~     This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with~     breast cancer and 120 control women, to evalyate if vitamin D status is associated with~     breast cancer risk.~   "
94727|NCT01817218|"~     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in~     all the assistance levels, and they have big repercussion referring to individual, social~     and labour levels, supposing a big consumption of human and material resources.The cure with~     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a~     decrease in the cicatrization time comparing to conventional methods in hospital levels,~     which becomes interesting contrasting its efficacy in primary care.~      AIM:Evaluate the practicability, security and potential of the autologous PRP in the~     treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid~     environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP~     classification).~      DESIGN:A pilot study will be executed, which will consist in a randomized clinical test,~     multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers~     will be studied, who will be between the age of 40-80 years old, and who will be attached to~     five health centers. Variables for the identification, following, result and patient profile~     have been defined. Emphasize the variables of ulcer area decreasing, CIVIQ index, % one~     cure per week .~   "
94728|NCT01817205|"~     The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and~     TACE for unresectable HCC~   "
94729|NCT01817192|"~     The optimal treatment for stage I non-small cell lung cancer (NSCLC) remains controversial.~     Radiographic surveillance alone has been recommended for stage I patients after the tumor is~     removed surgically from the lung, and this standard has been based on the fact that no~     previous clinical trial has demonstrated a benefit for stage I NSCLC patients who receive~     post-operative chemotherapy. These patients, however, have a substantial risk of death~     within five years after operation, ranging from approximately 30% to 45%, largely due to~     metastatic disease that is present immediately after surgery but that is undetectable by~     conventional methods. Some leading organizations therefore currently recommend~     post-operative chemotherapy as an alternative standard of care in stage I NSCLC patients who~     are considered to be at particularly high-risk. Up until now, however, there has not been a~     well-validated means to identify stage I NSCLC patients at high risk of death within five~     years after operation. A new prognostic tool, the Pervenio™ Lung RS Assay, which has been~     validated and definitively demonstrated in large scale studies to identify high-risk stage I~     patients with non-squamous NSCLC, is now available to all clinicians through a~     CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients~     randomly assigned to one or the other of these competing standards of care.~   "
94730|NCT01817179|"~     The purpose of this study is to evaluate how a functional electrical stimulation (FES)~     device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral~     palsy walk and perform other functional activities.~      The investigators expect to find that wearing the functional electrical stimulation device~     will improve walking and other functional activities of children with hemiplegic cerebral~     palsy. Participants will be trained in use of the device and will be required to wear it~     daily for 3 months. Each participant will be evaluated before beginning the intervention and~     after completing the intervention. This study will provide important information regarding~     the benefits of this treatment intervention in children with hemiplegic cerebral palsy.~   "
94731|NCT01817166|"~     The main objective of this study is to evaluate the efficacy and tolerance of 2 years of~     treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome~     at high risk for MS (CIS).~   "
94732|NCT01817153|"~     The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8~     hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic~     vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between~     post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound~     imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed~     by near-infrared spectroscopy).~   "
94733|NCT01817140|"~     The primary objective of this study is to improve the diagnostic accuracy and specificity of~     MRI in detecting the degree of bone involvement and invasion in oral cancer. The presence~     and degree of bone invasion determines the extent of surgery and has great effect on the~     morbidity of patients with oral cancer and bone/soft tissue tumors.~      MRI scanning in 3 Tesla (3T) and 4Tesla (4T) MR magnet will be performed on up to 10~     patients with possible maxillofacial and/or mandibular bone invasion. We will then compare~     the conventional imaging results of the patients with 3T and 4T MRI results and post~     operative pathology results.~   "
94734|NCT01817127|"~     This observational study is designed to determine how sugars, lipids and proteins in breast~     milk vary among mothers; is affected by maternal diet, health and microbiota and vary over~     the course of lactation. Additionally, the study is designed to determine how the structure~     and composition of complex milk sugars, maternal health status and diet influence the~     development and maintenance of infant gut microflora.~   "
94746|NCT01816971|"~     This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and~     after stem cell transplant works in treating patients with newly diagnosed multiple myeloma.~     Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and~     dexamethasone before and after stem cell transplant may kill more cancer cells~   "
94735|NCT01817114|"~     During a heart attack, an artery carrying blood and oxygen to the heart becomes blocked,~     which causes damage to the heart muscle. When possible, a clot-busting drug is given or a~     procedure called angioplasty is performed soon after a heart attack starts, to open up the~     blocked artery and restore blood flow to the heart. While this can be an effective treatment~     to reduce permanent damage to the heart, patients can still experience heart failure~     afterwards. Consequently many patients require medications to support their heart after a~     heart attack. Recent research has shown a new technique called Remote Ischemic conditioning~     or RIC, is effective at protecting the heart muscle in a heart attack. RIC is produced~     simply by repeated inflation and deflation of a blood pressure cuff on an arm or leg to~     temporarily cut off and then restore blood flow to that limb. The investigators believe this~     triggers the release of molecular factors that protect heart muscle. In a recent study in~     humans, it reduced the amount of permanent damage to the heart muscle when applied before~     the angioplasty procedure. The investigators recent animal studies have shown that RIC may~     also help the heart muscle recover after a heart attack if applied everyday during the month~     after a heart attack, by preventing heart failure. This is important for two reasons: first,~     currently the investigators can only treat heart failure with medications, and second, some~     people have heart attacks but are not suitable to have angioplasty and so are at greater~     risk of heart failure. Daily RIC may provide an easy and effective new treatment to prevent~     heart failure after a heart attack. This application proposes a preliminary study in humans~     to see if daily RIC can help heart muscle recovery after a heart attack.~   "
94736|NCT01817101|"~     The purpose of this study is to determine whether an omega-3 fatty acid supplementation is~     effective in the prevention of progressive cognitive decline in elderly people aged 75 years~     or older.~   "
94737|NCT01817088|"~     Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of~     Parkinson's disease. This procedure performed in two steps using electrophysiology. This~     study is a prospective, randomized and monocentric study to compare two DBS procedures with~     or without electrophysiology.~      A better control of targeting and trajectory is necessary before not using~     electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei~     with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the~     use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic~     nuclei without the need of electrophysiology.~      Two groups of patients will be followed: a first group of patients with a procedure under~     general anesthesia alone without electrophysiological stimulation and a second smaller group~     of patients with a first step of electrode implantation under awake surgery with~     electrophysiological stimulation followed by a second step under general anesthesia for the~     implantation of stimulator.~      Clinical results will be assessed at 6 months after implantation.~   "
94738|NCT01817075|"~     This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it~     works compared to control cleansing in preventing central line associated bloodstream~     infection and acquisition of multi-drug resistant organisms in younger patients with cancer~     or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce~     bloodstream infections and bacterial infections associated with the central line.~   "
94739|NCT01817062|"~     Objective:~      Due to high mortality rates the capillary leakage and the acute abdomen are important risk~     factors of the probability of survival. The aim of an optimal therapy of the acute abdomen~     within the neonatal period is beside the cure of the underlying disease the prophylaxis of~     capillary leakage with the help of optimised intra- and postoperative volume therapy.~      Question:~      Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit~     from early increase of the haemoglobin/haematocrit by optimised volume therapy with~     crystalloid and colloidal volume as prophylaxis of the capillary leakage?~   "
94740|NCT01817049|"~     Soccer accounts for more than 10% of all sport injuries in youth requiring medical~     attention. The injury rates in youth soccer where there is no established injury prevention~     program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000~     participation hours. Risk reductions ranging from 32-43% have been found for youth players~     participating in neuromuscular training programs, such as the FIFA 11+, that include~     agility, balance training, and strengthening components. Although studies have shown that~     the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the~     youth soccer community. It is therefore important to develop ways of delivering the program~     to soccer coaches and players in order to maximize its protective benefit. The Health Action~     Process Approach (HAPA) is a behavior change theory that has been used to successfully~     predict the uptake of health behaviours in a number of populations, such as cancer screening~     and exercise, but has not been tested in sport injury prevention settings.~      The primary objective of this study is to examine the effect of a HAPA-based coach education~     intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the~     course of one outdoor and one indoor season. The secondary objective is to examine the~     dose-response relationship between program adherence and injury, comparing program adherence~     and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches~     receive a HAPA-based intervention will have greater adherence to the program than teams~     whose coaches do not receive the intervention, and that that injury incidence will decrease~     as adherence to the program increases. It is expected that program adherence will be lower~     and injury rates will be higher in indoor soccer compared to outdoor soccer.~   "
94741|NCT01817036|"~     To determine the dose-response between the doses of vitamin D3 supplements and raised serum~     levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥~     75 nmol/L;~   "
94742|NCT01817023|"~     The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT)~     alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally~     advanced nasopharyngeal carcinoma.~   "
94743|NCT01817010|"~     To determine if patients who receive an 8 week, comprehensive, multi-component~     rehabilitation program (CMC) have better strength and functional performance compared to a~     control group (CON).~      The investigators hypothesize that functional performance and strength in the muscles~     surrounding the hip and the knee will be greater in the multi-component rehabilitation group~     compared to the control group.~   "
94744|NCT01816997|"~     Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems~     to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired~     fasting glucose.~   "
94745|NCT01816984|"~     This pilot randomized phase I/II trial studies the side effects and best dose of PI3K~     inhibitor BKM120 when given together with cetuximab and to see how well it works in treating~     patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumors to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may~     kill more tumor cells~   "
94750|NCT01816919|"~     Head and neck tumors are common in the general population especially in high risk groups of~     smokers and alcohol abusers, as well as after exposure to various environmental factors.~     Diagnosis is based on identification of patients gross disease after a physical examination~     and various imaging methods, and characterization of tissue mainly by fine-needle puncture~     (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging~     and tissue samples.~      Using the electronic nose technology we hope to identify microscopic disease when it is~     suspected or in populations in risk, thus diagnose patients in the initial stages of the~     disease. Obviously, early diagnosis and treatment decisions will hopefully improve the~     prognosis.~      Finding a positive correlation between the stages, levels and various tumor volume and~     respiratory specimens findings will classify patients more accurately and contribute to~     further characterization of the disease in a more accurate, rapid and non-invasive fashion.~   "
94751|NCT01816906|"~     This particular trial is looking to compare the effectiveness of two types of foot bed/ sole~     materials used within diabetic footwear.~   "
94752|NCT01816893|"~     The goals of this proposal are to determine the effects of hypoglycemia on the autonomic~     nervous system and whether administration of a mineralocorticoid receptor antagonist~     modifies the effects of hypoglycemia on the autonomic nervous system~   "
94753|NCT01816880|"~     The aim of this sub-study is to determine whether healthy individuals over 90 years of age~     possess immune cells that are involved in protection from chronic disease. The immune system~     is well known to produce anti-cancer and other immune cells, called antibodies that can be~     beneficial to our health. In this study the investigators will evaluate the immune status of~     the healthy individuals over 90 years of age. The investigators will be focused on studying~     molecules known to be involved in cholesterol, cancer like those for prostate cancer and~     breast cancer, inflammatory diseases, and infectious diseases like influenza.~   "
94754|NCT01816867|"~     The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This~     registry will collect data from 100 patients treated for a ventral hernia repair.~   "
94755|NCT01816854|"~     In this prospective study, a newly developed self-expanding nitinol stent is evaluated for~     the treatment of atherosclerotic lesions in the superficial femoral artery.~   "
94756|NCT01816841|"~     This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk~     patients and patients undergoing routine dental care. Diagnostic procedures, such as direct~     visual fluorescence, may help find and diagnose oral cancer.~   "
94757|NCT01816828|"~     Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual~     HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic~     sexual health information, review the current legal context surrounding HIV non-disclosure~     and use motivational interviewing (MI) to support participants in setting and achieving~     personal goals.~      In this randomized control trial phase of the research, the investigators are assessing the~     efficacy of the group counseling intervention, GPS. Participants are randomized to receive~     GPS immediately or to a wait list/standard of care condition. Participants are followed for~     a 6 month period and are asked to complete baseline quantitative assessments, as well as two~     qualitative interviews.~   "
94758|NCT01816815|"~     Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian~     function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD~     (pharmacokinetic/pharmacodynamic) relationship~   "
94759|NCT01816802|"~     The purpose of this study is to record and evaluate the use of traditional morphology~     grading combined with Eeva in the treatment of in vitro fertilization.~   "
94760|NCT01816789|"~     This randomized controlled trial has been designed for carrying out a comparison of new AMH~     (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide~     accepted age-based strategy. The main objective of the trial is to assess whether an~     individualized FSH starting dose can increase the rate of women with an adequate ovarian~     response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).~   "
94761|NCT01816776|"~     The primary purpose of this prospective, multicenter, randomized trial is to evaluate the~     safety and effectiveness of therapy delivered by the remedē® system in subjects with~     moderate to severe central sleep apnea and optimal medical management, compared to outcomes~     in randomized control subjects receiving optimal medical management and implanted but~     inactive remedē® systems.~   "
94762|NCT01816763|"~     In light of the importance of pain and widespread interest in patient-centeredness, the~     Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and~     its management a routine feature of the health record and a focus of care. Awareness of pain~     and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and~     practice of nursing staff routinely screening for 'pain now' at every health encounter using~     a 0-10 Numeric Rating Scale (NRS).~      The team's previous research on VA's '5th Vital Sign' informs the specific design of this~     Effective Screening for Pain (ESP) study as well as the proposed research products.~      Alternatives to the current pain screening approach may improve the sensitivity and~     specificity of screening for chronic pain. These alternatives include the nurse administered~     NRS with a one week look back period and a three item scale (PEG) incorporating intensity~     and emotional and physical interference. The PEG is very similar to the gold standard Brief~     Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and~     sensitivity to change in detecting clinically important, functionally impairing pain.~      The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for~     pain screening, focusing on simple, feasible measures that can be used cross-sectionally for~     pain screening. In the setting of a primary care clinic, the investigators plan to~     cross-sectionally evaluate three arms - a nurse documented NRS now, a tablet computer-based~     NRS one week, and a tablet computer-based PEG.~   "
94802|NCT01816243|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in Thai participants with chronic (lasting a~     long time) non-malignant (non-cancerous) pain.~   "
94803|NCT01816230|"~     A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit~     (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in~     Patients with Hematological Malignancies.~   "
94763|NCT01816750|"~     The recently introduced Computed tomography (CT) scanner, Discovery CT750 HD (GE Healthcare,~     Milwaukee), incorporates a battery of innovations aimed at improving diagnostic image~     quality, evaluating perfusion and assessing for scar, in an effort to address the current~     shortcomings of Computed tomographic coronary angiography (CTCA) in patients with~     significant coronary artery disease. The new scanner will use a novel method of scanning~     (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive~     Statistical Iterative Reconstruction- ASIR) as opposed to standard definition 64-slice CT~     Multi-detector row computed tomography(MDCT)and Filtered Back Projection (FBP) used by the~     conventional CT scanners. The Cardiac GSI protocol enables the scanner to acquire images at~     two different x-ray energies almost simultaneously, which can be post-processed to~     selectively reduce beam hardening artefacts and delete materials with specific attenuating~     properties from the images, such as coronary calcium. ASIR offsets the potential increase in~     radiation dose required for Cardiac GSI scanning. This will potentially result in images of~     higher diagnostic quality with an equivalent or perhaps lower dose of radiation compared to~     present technology.~      Furthermore, it is hypothesised that dual-energy acquisition may improve the accuracy of the~     assessment of perfusion.~      Although initial in-vitro results are encouraging, this technology has not been rigorously~     assessed with regards to its feasibility and diagnostic quality, limiting its applicability~     in routine clinical practice. This assessment will require a trial comparing the accuracy of~     Cardiac GSI CTCA with that of Invasive coronary angiography (ICA) for anatomical assessment~     of stenosis, Myocardial Perfusion Imaging with Single Photon Emission Computed Tomography~     (MPI-SPECT) for assessment of perfusion and Cardiac Magnetic Resonance (CMR) for assessment~     of myocardial scar. We have designed a pilot study in this regard which will help us assess~     the feasibility of the scan protocol and provide data to power a larger study to assess the~     diagnostic remit of Cardiac GSI scanning in the assessment of patients with high-risk of~     significant coronary artery disease and myocardial scar.~   "
94764|NCT01816737|"~     Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure~     induced by te abdominal ultrasound transducer. The investigators would like to study the~     response of flow in main fetal vessels to different, mild to moderate pressures induced by~     the abdominal transducer. The pressure induced by the transducer will be measured by a~     digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound~     Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each~     pregnant woman. Ones without applying transducer pressure (control) and ones after applying~     mild pressure.~   "
94765|NCT01816724|"~     The objective of this study is to validate the spanish (from Spain) version of the Nocturia~     Quality of Life Questionnaire and assess their psychometric properties, using the spanish~     translation provided by the copyright holder.~      Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by~     Intraclass Correlation Coefficient), Convergent Validity (assessed using other already~     validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health~     and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be~     evaluated.~   "
94766|NCT01816711|"~     The purpose of this study is to assess whether all frail elderly admitted with hip fracture~     has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture~     in frail elderly.~      Frail elderly are defined as being 65 years of age or older, and living in nursing homes or~     senior housings.~      The investigators' hypotheses state that:~        1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.~        2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin~          D than frail elderly without any hip fractures during the last ten years.~   "
94767|NCT01816698|"~     Prehypertension are associated with an increased risk of atherosclerosis and coronary artery~     disease, and often complicated with the metabolic disorder of glucose and lipid. The~     comprehensive prevention of hypertension is still an important and complex clinical issue.~     Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids~     is central inhibitory neurotransmitter, can regulate the excitability of nerve tissue,~     regulate body temperature, therefore, antipyretic, sedative, analgesic,~     anti-inflammatory,the role of anti-rheumatic, anti-convulsant. In addition, Taurine inhibits~     platelet aggregation in the circulatory system, lower blood lipids, to maintain the body's~     normal blood pressure and prevent atherosclerosis; protective effect on myocardial cells,~     can be anti-arrhythmic; special efficacy to lower blood cholesterol, to treat heart failure.~     The effect of oral Taurine on blood pressure is not consistent, however, many animal study~     has shown that oral administration of Taurine, could reduce 24-hour mean arterial systolic~     and diastolic blood pressure in spontaneous hypertensive rats. Furthermore, Taurine~     interfere with calcium and low affinity binding of the calcium binding sites, decrease the~     voltage-dependent Ca2+channel in vascular smooth muscle relaxation, vasodilation, lower~     blood pressure.In a prospective, double-blind, randomized, and parallel-group study, we will~     evaluate the effects of Taurine granule on blood pressure and metabolic parameters in~     prehypertensive and mild hypertensive patients. This study will help develop future~     comprehensive prevention and treatment strategies for hypertension.~   "
94768|NCT01816685|"~     Patients with a medical condition known as obstructive sleep apnea may be at increased risk~     of delirium following surgery. This study loans autotitrating CPAP machines to~     randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of~     preventing post-operative delirium.~   "
94769|NCT01816672|"~     The purpose of this study is to determine if AutoloGel platelet rich plasma used on non~     healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and~     customary care~   "
94770|NCT01816659|"~     The goal of this clinical research study is to learn more about the possible effects of~     metformin extended release (ER) in patients with colon cancer or adenomas who are about to~     have surgery. The safety of this drug will also be studied.~      Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is~     also designed to block a protein in tumor cells that is important in tumor growth and blood~     vessel development. This may cause cell death or reduce the spread of the disease.~   "
94771|NCT01816646|"~     The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose~     directly into the bladder is absorbed by the body. Researchers also want to measure the~     amount of study drug in the body at different time points. The safety and tolerability of~     this drug will also be studied.~      Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.~   "
94772|NCT01816633|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will~     be treated using AutoloGel and case-matched against a concurrent cohort of patients~     receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound~     Registry Research Network (USWRRN) centers.~   "
94773|NCT01816620|"~     The purpose of this prospective study is to determine the efficacy and safety of~     lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.~   "
94776|NCT01816581|"~     Postoperative pain and analgesic treatment still remains a challenge in daily perioperative~     medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal~     cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for~     postoperative pain. Poorly controlled pain can contribute directly or indirectly to~     postoperative complications, such as myocardial ischemia, pulmonary dysfunction like~     hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function~     and decreased mobility. In addition, prolonged acute pain also results in chronic pain.~      Opioids are internationally recognized as the golden standard in the treatment of acute~     postoperative pain. On one side, the high potency of opioids in pain relief is clearly~     undisputed, but on the other hand, the administration of opioids is associated with nausea,~     vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms~     including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is~     a frequently reported adverse effect and sometimes requires discontinuation of therapy,~     which results in analgesic under-treatment, severely impairing quality of life. However,~     there are many different regimes for the treatment of postoperative pain using opioids.~     Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff~     and expensive equipment. Once patients are able to tolerate oral medications, the oral route~     is preferred postoperatively because it is more convenient, noninvasive and less expensive.~   "
94777|NCT01816568|"~     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery~     with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using~     3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced~     hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS)~     was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this~     study the investigators aimed to compare results of SILS appendectomy and three port~     conventional laparoscopic appendectomy prospectively.~   "
94778|NCT01816555|"~     This study is for adult females who have been newly diagnosed with breast cancer that~     includes surgery as part of standard cancer treatment. This is a research study combining~     Vitamin D (an over the counter medication) with the standard of care (or the established and~     approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a~     higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to~     find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer.~     Screening tests will be done to determine if subjects are eligible to participate in this~     study. If subjects are eligible and they agree to participate, they will be assigned to one~     of two groups which will receive different amounts of vitamin D. Subjects will be asked to~     keep a medication diary. Subjects may remain on treatment for approximately 56 days.~   "
94779|NCT01816542|"~     The purpose of the study is to determine if any of Mother's Choice' all-natural~     personal-care products cause either irritation or allergic reaction when applied to both~     normal or sensitive skin.~      Each product will be tested on the skin using patch tests.~   "
94780|NCT01816529|"~     The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2%~     Cream to induce sensitization by repeated topical application to the skin of healthy~     subjects under controlled conditions.~   "
94781|NCT01816516|"~     Poor feeding practices during infancy contribute to obesity risk because they interfere with~     infant feeding self-regulation and appropriate growth patterns as infants transition from~     human milk and/or formula-based diets to solid foods. The goal of the project is to provide~     an educational intervention that fosters appropriate maternal responsiveness, feeding~     styles, and feeding practices via infant-centered feeding.~   "
94782|NCT01816503|"~     The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring~     satisfaction with pain treatment after administering fentanyl matrix in patients whose pain~     was not controlled sufficiently with the previous analgesic use in real practice at the~     investigator's discretion.~   "
94783|NCT01816490|"~     Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with~     an estimated number of 180 million infected patients. Until 2012 the current standard of~     care (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with~     pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir~     and boceprevir as first directly acting HCV drugs have been approved by the local Swiss~     authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However,~     therapy success is strongly limited in null-responders (NR) to previous PR. Treatment of~     HCV-HIV co-infected individuals with the new PI's is accompanied by additional challenges~     (e.g. drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis~     are at highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and~     prompt initiation of treatment is strongly recommended. Recently, data in mono-infected~     patients showed, that in prior non responders a 12 week course of a triple therapy (TT) with~     telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic~     response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable~     preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver~     fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These~     patients urgently need additional therapeutic options with the goal to eradicate HCV in~     order to prevent further fibrosis progression and to reduce morbidity and mortality. A~     promising substance in the field of drugs targeting the HCV replication is silibinin.~     Silibinin is the main component of silymarin, an extract of the milk thistle Silybum~     marianum. Intravenous silibinin (iSIL) targets multiple steps in the virus life cycle and~     exhibits anti-oxidant, anti-inflammatory, anti-viral and immunomodulatory properties. iSIL~     inhibits the HCV NS5B polymerase activity directly or by interfering with the binding of RNA~     to this enzyme. In addition, iSIL appears to block virus entry, virus transmission and virus~     secretion.In 2008 Ferenci et al. for the first time reported the substantial clinical~     antiviral-effect of intravenous silibinin (iSIL) against HCV in PR non-responders. The~     administration of 20mg/kg iSIL in 20 patients led to a highly significant decrease in viral~     load. We intend to investigate the effect and tolerability of iSIL in HIV-HCV co-infected~     individuals with advanced liver fibrosis and previous non- or partial response to SOC. All~     included study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day~     (expressed as silibinin concentration) once a day for 14 days. At the end of the THISTLE~     study, i.e. after the day of completion of the 14-day iSIL administration (day 15), the~     patients will be considered for eligibility to receive standard of care. We assume that the~     decline in HCV viral load would substantially improve the chances of SVR as the reduction of~     viral load should both increase the efficacy of PR and reduce the odds of drug resistance to~     HCV-specific protease inhibitor.~        -  Trial with medicinal product~   "
94784|NCT01816477|"~     Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced~     posteriorly. In severe cases, surgery is performed to correct the defect (1). In recent~     years, minimally invasive surgery with the placement of stainless steel support bars has~     been increasingly performed in patients over the age of 17 years (1-9). Because of the~     decreased malleability and tremendous pressure required to hold the chest wall in the~     corrected position, post-operative pain control has been a significant problem in this~     patient population (2,6,9-12). Thoracic epidurals are commonly employed however mean~     hospitalizations of up to 7 days have been required before adequate pain control on oral~     analgesics is obtained (3-5, 13) and patients are suitable for discharge.~      It is hypothesized that using the ONQ system (I-Flow Corporation, Lake Forest CA) with~     bilateral intercostal catheter infusion would provide adequate post operative pain control~     with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of~     narcotics for 1 week following surgery would also be less with the ONQ system versus~     epidural.~   "
94785|NCT01816464|"~     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in~     HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013.~     Safety data will also be collected.THe Pregnancy outcomes and the transplacental transfer of~     antibodies will also be assessed.~   "
94786|NCT01816451|"~     The purpose of this study was to verify physiological responses to constant-load~     (continuous) vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active~     men. The hypothesis was that would be differences in physiological variables on distinct~     modes of execution performed on the treadmill over a period of 14 weeks of training.~   "
94787|NCT01816438|"~     The main purpose is to describe clinical practices nowadays prospectively about patients~     with a dysplasia diagnosis or another histological lesions.~      It will be identified colic situation during the initial colonoscopy after dysplasia~     diagnosis or atypical lesion.~      Also the frequency and the type of monitoring conducted about these patients(surgical and~     endoscopic treatments).~      The main criterion evaluation will be the surgical and endoscopic rates during the time.~      The treatments offered such as surgical, endoscopic ones or none of them will be followed.~      Finally, the outcome of these patients: stability, lesion disappearance, surgery or~     development of cancer with frequencies for each of them and relationships with histological~     abnormal colorectal lesion will be measured.~   "
94788|NCT01816425|"~     The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects~     biomechanical principles, providing harmony between mechanical and biological activities.~     The fundamental principles of biomechanics applied in the manufacture of steel structure~     are: retention, reciprocity, attachment and stability. To get the proper planning, we need~     to assess the dental support system, with its qualitative and quantitative values. But~     conventional dentures has a inherent problem which is the metallic elements apparent and in~     some cases the stiffness of the component support elements that generates stress.~      The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in~     oral rehabilitation. So many treatments are being done in everyday practice without a~     defined concept on various aspects of its construction and oral applicability.~      This trial aims to assess the basic parameters of both dentures in: nutrition, speech~     therapy, chewing force, chewing efficiency and quality of life.~      60 years old or older patients who require removable prosthesis. These will be randomly~     selected for the fabrication and installation of removable partial dentures (Gold Standard -~     control group - CoCr partial denture) and thermoplastic partial denture(experimental group).~      Before beginning the work, selected patients will make some preliminary tests such as~     controlling the individual condition, they are:~        -  three questionnaires:~        -  instrument for assessing quality of life related to oral health, GOHAI - General Oral~          Health Assessment Index of Atchinson & Dolan~        -  instrument for assessing the social and economic profile of ABEP (Brazilian Association~          of Research Companies) CCEB 2011;~        -  Instrument for assessing cognitive condition MINI-MENTAL;~        -  Speech evaluation~        -  Nutritional assessment;~        -  Evaluation of masticatory efficiency and~        -  Chewing strength. After preliminary assessments patients will be subjected to~          treatments for manufacture of partial dentures. After the installation (end of the~          technical construction of the dentures) and the adjustments appointment the tests will~          be repeated and in successive control periods of 3 months, 6 months, 12 months, 18~          months and 24 months respectively, when the tests will do again now to see if there was~          a change in the initial condition.~   "
94789|NCT01816412|"~     To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion~     of the femoral and popliteal arteries in the Japanese population.~   "
94790|NCT01816399|"~     The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will~     facilitate the detection of significant coronary disease (CAD) in patients with normal rest~     12-leads ECG (NE).~   "
94791|NCT01816386|"~     In the present study, the investigators want to evaluate if press needle acupuncture applied~     prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve~     fast-track anaesthesia in the PACU after general surgery.~   "
94792|NCT01816373|"~     The purpose of this study is to determine whether the non-invasive negative pressure~     treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum~     treatment~   "
94793|NCT01816360|"~     The purpose of this study is to verify and analyse psychological and physiological effects~     of olfactory aromatherapy and yogatherapy respiratory exercises, together and separately, on~     the quality of life, levels of stress, quality of sleep and intensity and frequence of hot~     flashes in climacteric women.~   "
94794|NCT01816347|"~     The cyclic movement of the heart and the coronary arteries induces relative axial movement~     between the artery and a pre-deployed intra-luminal stent which may cause malpositioning.~     Using a new imaging algorithm to indicate the position of a stent in patients undergoing~     percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment~     relative, intra-luminal stent axial movement in the different coronary arteries to~     facilitate the precise deployment site.~   "
94795|NCT01816334|"~     The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids~     are effective in the treatment of acute sciatica~   "
94796|NCT01816321|"~     In combination with the existing literature, previous work indicates that 1) women with poor~     ovarian response fulfilling the Bologna criteria have very low pregnancy rates,~     irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that~     do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing~     pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings~     provide a strong rationale for a definitive large RCT. The COMPORT study will provide~     conclusive evidence regarding the superiority or not of this novel protocol with~     corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders~     fulfilling the Bologna criteria.~   "
94797|NCT01816308|"~     This study aims to compare the incidence of new-onset cognitive impairments and change in~     existing impairment status between AF patients undergoing either catheter ablation or~     remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment~     (MoCA).~   "
94798|NCT01816295|"~     The main purpose of this study is to evaluate if testosterone solution can raise~     testosterone hormone levels into the normal range, and also improve levels of sexual~     arousal, interest and drive and/or energy level, in men with low testosterone and decreased~     sexual arousal, interest and drive and/or decreased energy. The study will last about 16~     weeks, followed by an optional 24 week open label treatment phase to investigate the long~     term safety of testosterone solution.~   "
94799|NCT01816282|"~     A randomized controlled study is performed to address the question of whether the topical~     application of a novel fibrin sealant, Evicel (Johnson & Johnson Wound Management, Ethicon,~     Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative~     blood loss and the need for allogenic blood transfusion compared to a control group. We~     hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after~     total knee replacement.~   "
94800|NCT01816269|"~     Patients who had received H.pylori eradication treatment will be categorised as eradication~     and reinfection status and whether dental scaling has any influence on these results.~   "
94801|NCT01816256|"~     This study involves screening for portal vein thrombosis and portal hypertension in patients~     with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia~     vera (PV), essential thrombocythemia (ET), and myelofibrosis.~      Portal vein thrombosis and portal hypertension are serious complications that are often seen~     in myeloproliferative patients. These complications are usually diagnosed when patients~     become symptomatic, and are often already at an advanced stage. They can further progress to~     cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of~     this, patients often accumulate fluid in the abdomen which is ascites; and can develop~     swelling of veins in the lining of the esophagus known as varices. If untreated, varices~     have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an~     advanced stage, the treatment is usually supportive therapy and there are no treatments~     available at present which can reverse these conditions.~      This study is looking at screening for these two conditions using Doppler ultrasound and~     upper gastrointestinal endoscopy.~   "
96130|NCT01798849|"~     This study will evaluate safety, tolerability and effects on central diastolic blood~     pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A~     and B) and in male participants with mild-to-moderate hypertension (Panel C).~   "
94804|NCT01816217|"~     Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New~     videolaryngoscope devices are proposed to improve airway management in ICU patients. We~     aimed to compare a new videolaryngoscope called  McGrath Mac Video Laryngoscope vs~     standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or~     Cormack 3-4 rates in a prospective interventional study.The present study was conducted to~     test the hypothesis that the implementation of a quality-improvement process for airway~     management using a new videolaryngoscope would be associated with a decreased incidence of~     difficult intubation and/or Cormack 3-4.~   "
94805|NCT01816204|"~     Therapist assisted, internet-based cognitive behavioral therapy (TAI-CBT) has been shown to~     be effective with patients who have Generalized Anxiety Disorder (GAD) in multiple studies~     from several countries, including: the United Kingdom, Australia, Sweden, and the~     Netherlands. Despite strong evidence of efficacy, TAI-CBT has not been offered in the USA.~     TAI-CBT could provide an effective alternative to face-to-face psychotherapy that would~     expand the availability and convenience of evidence- based treatment anywhere clinical~     availability is limited. The University of Florida (UF) has historically had greater demand~     for psychotherapy than the available supply of psychotherapy hours resulting in waiting~     lists for students needing to receive treatment for anxiety. Anxiety disorders interfere~     with memory and concentration thus impairing academic functioning. Students who must wait~     for treatment for 3-4 weeks are at risk for failing courses or dropping out of school. If~     TAI-CBT proved to be effective with UF students, providing it could increase the number of~     students who would receive effective and timely treatment. This project will create a 6-8~     session therapist assisted on-line treatment for anxiety disorder. The investigators will~     offer TAI-CBT as an experimental treatment in summer and fall, 2013 comparing outcomes to~     face-to-face individual therapy, group therapy, and wait-list controls. The investigators~     hypothesize that students receiving TAI-CBT will have a reduction in anxiety symptoms~     comparable to face-to-face counseling and greater than wait list controls.~   "
94806|NCT01816191|"~     The study is a single-center, open-label, safety and pharmacokinetic study in12 adult~     subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7~     days of treatment. There will be three parts to the study and all subjects will participate~     in each part.~   "
94807|NCT01816178|"~     It was proposed that in order to teach these children to use a Voice Output Communication~     Aid (VOCA), it should be introduced through a play-based situation using parents as the~     primary interventionist.~   "
94808|NCT01816165|"~     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk~     in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor~     to IR in T1D and may be a target of intervention. The hypothesis of the study is that~     isolated fatty acid lowering with acipimox will improve insulin action and blood vessel~     function and have the benefit of reducing mitochondrial oxidant generation and improving~     mitochondrial function in T1D. Targeting IR through fatty acid lowering is a novel approach~     to T1D treatment that may significantly improve current management of TID and of~     cardiovascular disease (CVD) risk in this high risk population.~   "
94809|NCT01816152|"~     Tailored light treatment will increase sleep efficiency, reduce depression and reduce~     agitation scores in those with Alzheimer's disease and related dementia~   "
94810|NCT01816139|"~     The primary objective of this study is to compare the efficacy of WC3011 with placebo~     vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal~     atrophy as measured by self-assessment, vaginal pH and vaginal smear.~   "
94811|NCT01816126|"~     Colonoscopy can be performed by a one-operator technique with endoscopist personally~     advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant~     doing the physical insertion and withdrawal of the scope directed by the endoscopist.~     Uncontrolled data report that 1 operator technique is associated with a higher adenoma~     detection rate, although it is also characterized by a lowwer cecal intubation rate and~     longer intubation time. The aim of present randomized controlled study was to assess whether~     one technique is better than the other one in terms of colonoscopy quality performances.~   "
94812|NCT01816113|"~     This is an open label phase Ia study, to assess the safety of two novel malaria vaccines,~     ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our~     knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can~     importantly also induce antibodies. Previous clinical trials using this regimen expressing~     ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later~     by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide~     comparability with previous ChAd63-MVA trials, we propose to use a similar administration~     schedule.~   "
94813|NCT01816100|"~     This study is a unique blend of new technologies never used in combination with individuals~     diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in~     brain activity, functional brain activation and diffusion in the brain following 6 months of~     structured weight resistance and balance training. Positive changes would indicate that the~     therapy has ignited brain plasticity and may drive the brain to repair itself. These changes~     to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and~     slowing of neural degeneration. No other trials have been published evaluating brain~     plasticity utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in~     subjects with MS undergoing physical training. DTI has demonstrated the ability to find~     changes (plasticity) that occur in the brain and using the MEG findings to focus the DTI~     analysis will optimize the capacity to detect changes secondary to therapy. This~     quantification will give a better understanding of the repair that goes on in the brain, and~     may potentially revolutionize the field of the central nervous system (CNS) rehabilitation.~     One of the most innovative aspects of this study is the full integration of clinical~     neurobehavioral metrics and functional imaging data in conjunction with a proven MS therapy~     along with quality of life indicators. This approach will allow new links to be illuminated~     as the trajectories of functional and structural brain changes (neuroplasticity) are meshed~     with clinical improvement indices collected visit-by-visit. This study will also compare~     disease modifying treatments (DMTs) and their effect(s) on indices of brain plasticity and~     cognitive and behavioral assessments.~   "
94814|NCT01816087|"~     The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the~     primary care setting.~   "
94815|NCT01816074|"~     We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder~     (ADHD) will have a beneficial effect that extends to the child. We believe that~     multi-component interventions combining maternal stimulant medication, Lisdexamfetamine~     (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child~     outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well~     to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may~     benefit most from multi-modal treatment~   "
94816|NCT01816061|"~     Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD~   "
94817|NCT01816048|"~     The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate~     treatment response in bone metastases in subjects with prostate cancer treated with the~     investigational drug, TAK-700.~   "
94818|NCT01816035|"~     This phase I trial studies the side effects and best way of giving ado-trastuzumab emtansine~     in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast~     cancer that has spread to other parts of the body or nearby tissue and cannot be removed by~     surgery. Biological therapies, such as ado-trastuzumab emtansine, may stimulate the immune~     system in different ways and stop cancer cells from growing.~   "
94819|NCT01816022|"~     This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative~     neoplasm) to the bone.~      The hypothesis is that patients with CMPN have a higher fracture-rate compared to the~     background population. We expect to find a lower BMD using conventional DXA scan (dual~     energy x-ray absorptiometry), and a change in other parameters using HR-pQCT~     (high-resolution peripheral quantitative computerized tomography).Biochemical bone markers~     is measured to support the hypothesis.~   "
94820|NCT01816009|"~     The study is a prospective, open randomized, non-inferiority trial with two parallel groups,~     comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure~     (debridement and retention, 1-stage or 2 stage exchange).~      The duration of the treatment antibiotic of prosthetic joint infections is only based on~     experts' opinion ; this one varies from 6 weeks to several months according to the customs~     of the influencer.~      The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12~     weeks antibiotic therapy duration, both associated with surgical procedure (debridement and~     retention of implant, one-stage or two stages exchange), in PJI treatment.~      The study concerns 410 men or women of more than 18 years include in 34 centres in France.~      The duration of the study is of 4 years.~   "
94821|NCT01815996|"~     The investigators are developing a test that is expected to measure the amount of radiation~     a patient has been exposed to after a nuclear bomb. The investigator will do this by~     measuring the DNA in the patients blood from cells killed by the radiation.~      Many diseases and medical conditions can put DNA in the blood. The investigator needs to~     know how much DNA in order to better interpret our radiation detection test. Therefore, the~     investigator is collecting blood from several patients with different diseases or medical~     conditions and also healthy volunteers to measure their DNA content.~      Patients that will be included in this study are pregnant women, patients who have suffered~     a pulmonary embolism within the past 48 hours, patients who have suffered from myocardial~     infarction in the past 48 hours, patients with autoimmune diseases and health patients.~   "
94822|NCT01815983|"~     This study is designed to evaluate the impact of a video recording review on the acquisition~     of a new technical skill (laryngoscopy and tracheal intubation).~   "
94823|NCT01815970|"~     Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death~     world-wide. Dyspnea (i.e., sensations of breathlessness) is the hallmark symptom of patients~     with this disease. Pulmonary rehabilitation programs that incorporate exercise training~     remain the most effective non-pharmacological method of reducing dyspnea in COPD, however it~     is not understood how exercise training relieves dyspnea. Accordingly, the purpose of this~     study is to determine if pulmonary rehabilitation can reduce the disparity between the drive~     to breathe and the breathing response in patients with COPD and to determine if this~     reduction is associated with improvements in dyspnea during exercise.~      The investigators hypothesise pulmonary rehabilitation will reduce dyspnea at a standardized~     work rate and this reduction will be directly related to an improvement in the breathing~     response.~   "
94824|NCT01815957|"~     This study is being done to determine if Ranolazine treatment improves coronary~     microcirculation function among patients with coronary microcirculation dysfunction. We are~     also looking to learn if symptomatic improvement of chest pain during treatment with~     Ranalozine is related to improved coronary microcirculation function.~   "
94825|NCT01815944|"~     Regional anesthesia employs the use of local anesthetics (LA) to block specific nerves to~     enable pain free surgery to be performed, or for intra and post operative pain relief.~     Dilution of local anesthetics with normal saline (NS) is a common practice to enable larger~     volumes of LA to be given, for example, in instances where multiple nerve blocks are needed~     to be performed for optimal pain relief while avoiding toxic doses.~      A high sodium concentration is known to antagonize the analgesic effect of local~     anesthetics. 5% dextrose (D5W) on the other hand is painless on injection and does not cause~     any long-term effects in animals or humans when injected around neurological tissue. In the~     literature, only one study using dextrose 5% as diluent to produce 0.5% ropivacaine for~     axillary brachial plexus block showed a statistically significant reduction in the onset~     time for sensory blockade when compared with dilution with NS.~      In this study, 0.5% ropivacaine diluted with D5W or NS is used for ultrasound guided~     supraclavicular brachial plexus block, and the time for complete sensory and motor blockade~     was compared. 0.5% ropivacaine is easily diluted and is a common concentration used at our~     centre for nerve blocks. The aim of this study is to assess if 0.5% ropivacaine diluted with~     D5W results in a shorter onset time for sensory block which may change the current practice~     of dilution with NS~   "
94826|NCT01815931|"~     In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the~     ED.~   "
94870|NCT01815359|"~     This is the first randomized trial comparing Early post-operative intraperitoneal~     chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal~     and colorectal cancer. The purpose of this study is to find out what effects, good and/or~     bad, EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal,~     rectal or colon cancer.~   "
94827|NCT01815918|"~     One postoperative complication following unilateral or bilateral total knee replacement is~     thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled~     clinical trial, researchers are investigating the effect of steroids on biochemical markers~     of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have~     been linked to postoperative depression following total knee replacement surgery. Hence the~     investigators are also checking if use of hydrocortisone, a steroid, may help reduce the~     incidence of postoperative depression.~      Other studies have shown that surgery causes some reaction in the body that is consistent~     with inflammation. When the inflammation is extensive, it may affect different parts of the~     body. It may also lead to clotting disorders and result in blood clots. In a previous study~     by this principal investigator (see reference 22, Use of low-dose steroids in decreasing~     cytokine release during bilateral total knee replacement), hydrocortisone was administered~     over 24 hours following surgery to patients who underwent bilateral total knee replacements.~     The investigator found lower levels of cellular markers consistent with inflammation~     (specifically the protein, IL-6). Steroid use also showed additional benefits, such as~     decreased pain and better range of motion at the knee.~      In this study, investigators recruit patients undergoing total knee replacement surgery.~     Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a~     saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect~     on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients'~     oral analgesic use. To assess patients' well-being, patients are contacted one month and 3~     months following their surgeries and administered the Patient Health Questionnaire (see~     reference 23, The PHQ-9: validity of a brief depression severity measure.)~   "
94828|NCT01815905|"~     Provides mobile programs for occupational and speech therapy to patients with stroke.~   "
94829|NCT01815892|"~     Patients often begin dialysis taking diuretics (stimulate the kidney to excrete salt and~     water). Once on dialysis, these drugs are often continued. Whether these drugs are still~     needed, or even effective is often unclear.This study,by evaluating the composition of the~     patients' urine when off the drug, will predict which patients should benefit from the drug.~     By comparing their 24 hour volume both off and on the drug, the impact of the drug will be~     established. The results will allow the prediction of which patients, in the future, should~     take the drug. The hypothesis is: Among dialysis recipients, evaluation of the random urine~     sodium concentration will help predict the likelihood of a positive response to Furosemide,~     as manifested by an increased urine volume and sodium excretion.~   "
94830|NCT01815879|"~     Investigator initiated multi-institutional retrospective review of clinical and radiographic~     outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver~     metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks~     follow up.~   "
94831|NCT01815866|"~     Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and~     water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency.~     They have been demonstrated to cause clinically significant lung disease in some cases and~     the transmission of NTM, from person to person has been proposed. There are currently no~     standardized guidelines for isolation of those colonized or infected with NTM.~      The investigators will measure particle droplet size from patients with CF who have positive~     sputum cultures for NTM with the hypothesis that they will be in a range that can spread~     infection.~   "
94832|NCT01815853|"~     Background: It has been shown that the patitents with gastric cancer could benefits from~     peri-operative chemoradiotherapy, but whether the pre-operative chemoradiotherapy can~     improve patitents' outcome is still unclear.~      Patients and methods: In this study , patients with histologically confirmed gastric cancer~     whose pre-operative staging are cT4 any N,MO, aged from 18 to 70 years and with Eastern~     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized~     1:1 to receive pre-operative chemoradiotherapy with DT45Gy/25f plus two cycles of~     XELOX(Xeloda 1000mg/m2, BID, DI-D14; Oxaliplatin 130mg/m2 on day 1;,21-days per cycle) or~     chemotherapy alone then following by surgical resection and adjuvant chemotherapy with XELOX~     at the same dose up to 4 cycles. The primary end point is overall survival (OS), and~     secondary end point is disease free survival(DFS) and safety. Final study analysis will be~     conducted in the end of the 5th year after the last patient's enrollment.~   "
94833|NCT01815840|"~     This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess~     the efficacy and safety of two different vismodegib regimens in participants with multiple~     basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either~     in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as~     24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8~     weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.~   "
94834|NCT01815827|"~     This open-label, parallel group study will evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy~     volunteers compared to Caucasian healthy volunteers. Subjects will receive a single~     intravenous dose of inclacumab. Follow-up will be for up to 197 days.~   "
94835|NCT01815814|"~     The investigators hypothesize that children with spastic cerebral palsy will show greater~     improvements in gross motor function, associated developmental skills and growth after the 3~     months of myofascial structural integration treatment, a form of deep massage, than they~     showed after a 3- or 6-month pre-treatment waiting period.~      The investigators further hypothesize that children with spastic CP will maintain their~     gains in gross motor function for ≥ 3 months after completion of MSI treatment.~   "
94836|NCT01815801|"~     The purpose of this study is to determine whether mechanical ventilation influences the~     incidence of pneumothorax after subclavian venous catheterization.~   "
94837|NCT01815788|"~     A personal sound amplifying device (PASP) like Teo First is a wearable electronic product~     that is not intended to compensate for impaired hearing, but rather is intended for~     non-hearing impaired consumers to amplify sounds in the environment for a number of reasons,~     such as for recreational activities. Nevertheless, a lot of mild and moderate impaired~     hearing people don't want to buy and wear all day a real hearing aid.~      The goal of our study is to evaluate the benefit of such a device for mild and moderate~     presbycusis patient 60 years of age and older, with no previous hearing aid.~   "
94838|NCT01815775|"~     The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for~     patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the~     depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery.~     The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of~     predictive value of surgery response.~      In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive~     examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and~     4th ventricle levels.~   "
94839|NCT01815762|"~     Patients will be selected from the Dialisys Centers in Iasi, Romania. Patients will be~     randomized 1:1 to have a dry-weight assessment based on clinical (control) or lung US and~     bioimpedance (active) guided protocol. In the control group post-dialysis dry weight will be~     adjusted based on clinical criteria only (blood pressure, presence of edema, intradialytic~     hypotension, cramps etc.) and in the active group the target weight will be prescribed using~     lung US and bioimpedance evaluation.~      In patients randomized to the active arm of the study, the US B-line score (BLS) will be~     measured before dialysis and these measurements will be used to titrate ultrafiltration~     prescription. In patients presenting moderate to severe lung congestion (≥15 BLS~     pre-dialysis) LUS measurements will be repeated once a week until the treatment goal was~     achieved (<15 BLS pre-dialysis) and once a month thereafter. The same (monthly) monitoring~     frequency will be adopted also in patients without pulmonary congestion at pre-dialysis~     baseline (<15 BLS). Furthermore, the use of the technique is allowed whenever its~     application is deemed useful to assume clinical decisions by attending physicians. Patients~     in the active arm of the study without evidence of lung congestion at baseline who developed~     pulmonary congestion (≥ 15 BLS) during the trial will received the same treatment~     contemplated for those with lung congestion at baseline during the trial. The treatment goal~     will be pursued by ultrafiltration intensification realized within the same HD schedule (3~     sessions x 4 hours/week) or, if not tolerated, by extra-dialyses, according to individual~     tolerance and feasibility. In case of clinical hypovolemia (persistent cramps, hypotension~     etc) additional dry-weight adjustments will be performed according to the bioimpedance~     measurement, provided that the patients are below 15 BLS. This addition will be necessary in~     order to be able to increase the dry-weight in patients with a persistent BLS < 15 and avoid~     under perfusion.~      Patients in the control arm of the study will be followed up and managed strictly with~     standard criteria according to current recommendations (implying optimization of fluids~     volume control on the basis of clinical criteria and the use of carvedilol, ACE~     inhibitors/sartans whenever deemed necessary); the use of lung US / bioimpedanc assistance~     will not be messured in these patients.~      The main exclusion criteria will be the presence of severe cardiac failure (NYHA class~     III-IV), past myocardial infarction, stable or unstable angina and acute coronary syndrome.~     Due to bioimpedance assessment limitation patients with metallic joint prostheses, cardiac~     stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations will be~     excluded, as BIS cannot be accurately performed in such cases. Due to lung US measurement~     limitation we will exclude patients with known persistent pleurisy, pulmonary fibrosis or~     pneumectomy. Other exclusion criteria will be malignancy, active infections, temporary or~     permanent catheter as a vascular access, mental incompetence and unwillingness to~     participate in the study.~   "
96131|NCT01798836|"~     To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH~     agonist /GnRH antagonist protocol~   "
94840|NCT01815749|"~     This phase I trial studies the side effects and best dose of genetically modified T-cells~     following peripheral blood stem cell transplant in treating patients with recurrent or~     high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop~     the growth of cancer cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white~     blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune~     response against the body's normal cells. Removing the T cells from the donor cells before~     transplant may stop this from happening. Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) later may help the patient's immune system see any remaining cancer~     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor~     effect)~   "
94841|NCT01815736|"~     This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide~     (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil~     fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected~     participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.~   "
94842|NCT01815723|"~     This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group~     study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared~     to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial~     wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study~     treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily~     Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9~     weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a~     separate open label treatment protocol expected to continue for up to 5 years.~   "
94843|NCT01815710|"~     An Ontario-wide study to identify best strategies to promote uptake of high quality, expert~     developed Clinical Pathways (CPs) within Emergency Departments.~      The investigators will work with 16 Community EDs across Ontario to i) tailor an~     implementation strategy that works for each ED, ii) assist with the implementation of one~     pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the~     impact on health professionals, patient outcomes and economic costs. The investigators will~     conduct a 3.5 - year mixed methods health services research project with four study~     objectives: 1) to design a theory-based and knowledge user-informed intervention strategy to~     successfully implement two provincial pediatric emergency clinical pathways into practice in~     community Emergency Departments (EDs); 2) to evaluate the effectiveness of this~     implementation strategy; 3) to conduct a process evaluation to assess the implementation~     strategy; and 4) to conduct an economic analysis to evaluate implementation costs and~     benefits.~   "
94844|NCT01815697|"~     The purpose of this study is to see if enhanced external counterpulsation treatment can~     improve lower tract symptoms.~   "
94845|NCT01815684|"~     The purpose of this study is to explore the safety (including the effect on cardiac~     intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the~     CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and~     female subjects.~   "
94846|NCT01815671|"~     A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to~     systematically evaluate the diagnostic utility and incidence of adverse events in women~     using standard horizontal compared to lateral tilt down positioning for colonoscopy.~   "
94847|NCT01815658|"~     The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED~     composite, that is biomechanically tailored to closely match cortical bone. This IMN should~     promote fracture healing and prevent stress shielding osteopenia.~      Case records of patients with humurus shaft fracture will be retrospectively reviewed to~     determine whether the implant promotes bone healing.~   "
94848|NCT01815645|"~     Crack addiction has became a severe health problem in Brazil. Today, crack addiction is the~     primary cause for inpatient treatment (voluntary or not) for all illicit substances (losing~     only for alcohol addiction). A survey study conducted with children and adolescents~     currently living in the streets of 5 major cities of Brazil, point alarming results in which~     15% to 26% of all these children have smoked crack at least once in the last month.~      When compared to cocaine, crack users develop much faster diagnoses for crack dependence~     (mean of 5 month after first use), shows a more compulsive pattern of use, has higher~     probability of living or have lived in the streets, and of engaging in illegal activities.~     Consequently to this, mortality of crack addicts are 7 times higher than for the rest of the~     population.~      Despite all efforts being made for the development of effective pharmacological treatments~     for stimulant addiction (crack included), up to today, there is no robust evidence of~     efficacy of any pharmacological treatment. For that reason, the use of evidence based~     psychosocial interventions is so important for treating this population.~      Although today open treatment facilities in Brazil are more and more starting to use~     evidence based interventions such as motivational interviewing, cognitive behavior therapy,~     relapse prevention and coping skills, such treatments present very modest results when~     treating crack addiction. The biggest difficulties encountered when treating this population~     are maintaining patients in treatment, reducing crack use and achieving continued~     abstinence.~      A psychosocial treatment based in behavioral principals' named Contingency Management (CM)~     is widely applied in the USA. Recent meta-analyses and review studies present robust~     evidence that, when applied alone or in adjunction with other psychosocial and~     pharmacological treatment, CM is the most effective treatment for what regards, treatment~     retention, reducing drug use and promoting continued abstinence.~      The purpose of this study is to evaluate if Contingence Management (CM) treatment can be~     affective on the treatment of crack addiction for Brazilian population seeking outpatient~     treatment.~      To accomplish this, 60 individuals (male and female from 18 to 65 years of age) seeking open~     treatment for crack addiction will be randomized to 2 treatment conditions (Standard~     treatment (ST) or ST plus CM). Both treatments will last 12 weeks with 3 and 6-month~     follow-up. In both groups patients will be encourage to leave urine samples 3 times week.~      Hypotheses: Patients receiving ST+CM will stay longer in treatment, have more negative tests~     for cocaine/crack, and achieve longer periods of cocaine/crack abstinence when compared to~     patients receiving ST alone.~   "
94861|NCT01815476|"~     Participants undergoing radiation after breast conserving surgery for an early breast cancer~     (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at~     increased risk of developing a skin reaction because of their large breast size.~      After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or~     early stage invasive breast cancer receive radiation to the breast to decrease the risk of~     cancer recurrence. Breast radiation is usually done with women lying on their back~     (supine). Some women develop temporary breakdown of the skin (moist desquamation). This~     skin reaction can be painful and has been linked to long term side effects such as chronic~     pain and decreased quality of life.~      This study is being done because women with large breasts have higher rates of skin~     breakdown (called 'moist desquamation') and breast pain during and shortly after radiation~     therapy is complete. It is unclear if such skin reactions and pain would be improved by~     alternating treatment position - namely lying on your belly (prone) during their radiation~     treatment.~   "
94849|NCT01815632|"~     Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy~     €9 billion/year, through both direct and indirect consequences of progressive disability.~     Despite the usual relapsing-remitting presentation, over 80% of patients develop progressive~     disability; 40% require a wheelchair within 10 years of diagnosis. At present, there are no~     treatments that reverse, halt or even slow progressive disability in MS.~      The investigators recently completed one of the first feasibility/safety trials in the world~     of reparative bone marrow cell therapy in 6 patients with longstanding MS~     (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and~     intensive repeated tests on the patients measuring nerve conduction in various pathways in~     the brain and in the spinal cord showed statistically significant improvements at 12 months~     in every patient. While highly preliminary and involving only a very small number of~     patients, these results at least raise the possibility of a significant (though very~     partial) underlying repair effect within the damaged nervous system.~      The investigators believe this urgently requires further testing - both to accelerate~     benefit for patients, and to begin improving therapeutic efficacy. The investigators~     therefore propose a programme of translational and clinical stem cell research, aiming (1)~     to continue translation with a phase two controlled trial of bone marrow cells in patients~     with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by~     studying bone marrow cells from treated patients and control subjects, aiming to establish~     which of the various relevant bone marrow subpopulations contribute to efficacy, and which~     particular reparative mechanism(s) are important. The investigators hope these studies will~     not only confirm the therapeutic benefit of this approach, but also provide the basis for~     improving the magnitude and impact of this novel and exciting treatment modality.~   "
94850|NCT01815619|"~     This study will test two different methods for processing biopsy specimens taken from the~     bile duct. Patient;s who are asked to participate int his study have a growth (mass) in the~     bile duct that needs a biopsy so a diagnosis can be made. Standard of care includes~     performing 5-7 biopsies in the bile duct and sending the tissue to the lab for testing to~     make a diagnosis. Using this method the investigators can establish a diagnosis only about~     50% of the time. The investigators believe that if a pathologist is available in the~     endoscopy suite during the procedure, the investigators can improve the test results. The~     purpose of this study is to compare the two methods for processing biopsies obtained from~     the bile duct.~   "
94851|NCT01815606|"~     This study will test two different needles for performing a biopsy of the pancreas during~     endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study~     have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a~     diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The~     purpose of this study is to compare which of the two needles is better for performing~     biopsies of the pancreas on masses that are greater than 35mm.~   "
94852|NCT01815593|"~     The purpose of this study is to determine whether Enhanced External counterpulsation~     treatment can improve erectile function~   "
94853|NCT01815580|"~     This study will recruit men and transgender women with acute or recent HIV infection. It wil~     look at how HIV medicines (ART) when given very early after HIV infection affect the amount~     of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using~     modeling studies to look at whether or not this kind of HIV treatment can decrease the risk~     that a man will infect a person he has sex with and to find out how failure to take~     medications will impact spreading the virus to other people.~      In this study, one group will be randomized (like a coin toss) to start ART immediately~     (just at the time of the enrollment visit) and the other group will wait until week 24 of~     the study to start ART. Both groups will be followed for a total of 48 weeks and will~     continue to receive ART from local sources after the study is over.~   "
94854|NCT01815567|"~     The purpose of this study is to study the impact of blood pressure on cognitive performance.~   "
94855|NCT01815554|"~     This is an observational longitudinal study designed to identify and describe long term~     outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As~     this is not a randomized or experimental study, no specific hypotheses are proposed. The~     data collected will enable us to answer the following research questions:~        1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS~          stimulus parameters, abandonment of DPS and related reasons).~        2. What mechanical problems have DPS users encountered (system failure, repairs needed)?~        3. What are the frequency of and reasons for rehospitalization following DPS implant?~        4. What levels of care are needed at home to manage the DPS?~        5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste,~          swallowing)?~   "
94856|NCT01815541|"~     This is a biomedical research, prospective, mono centric, tolerance study Of the~     administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.~   "
94857|NCT01815528|"~     Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with~     recurrent ovarian cancer to investigate the feasibility and clinical activity of initial~     intraperitoneal catumaxomab followed by chemotherapy regimes.~   "
94858|NCT01815515|"~     This research is being done to see if an investigational radioactive drug called 18F-DCFBC~     can help us find cancer that has spread (metastatic disease) from its original site in~     people who have cancer in their prostate to other parts of their body.~   "
94859|NCT01815502|"~     The study will investigate the cardiovascular effects of sildenafil on patients with Fontan~     circulation. Recent studies suggest that sildenafil may improve exercise in patients with~     Fontan circulation. However, why this occurs is not known. The study will used specialized~     catheters to measure pressure and volume. The measure of pressure and volume leads to more~     detailed analysis of heart function. Patients will receive either sugar pill or sildenafil~     prior to catheterization. It is believed that sildenafil will improve relaxation and~     contraction of the heart.~   "
94860|NCT01815489|"~     Necrotizing pancreatitis is a severe form of inflammation of the pancreas with subsequent~     destruction of the pancreas (necrosis). Often, this condition manifests in patients as an~     overwhelming systemic inflammatory response and multisystem organ failure. Many times the~     pancreas can become superinfected with bacteria and other organisms as a result of this~     process. Clinicians may decide to sample fluid from the pancreas or pancreatic tissue to~     determine the presence of infection. This can be done through surgery with a concurrent~     debridement and drainage of the pancreas or by a radiologist using an ultrasound or CT~     guided method to sample the pancreatic fluid. These samples are then sent for culture in the~     microbiology laboratory. Culture results often reveal 1-2 types of infecting bacteria that~     originate from the gastrointestinal tract. The investigators hypothesize that in actuality,~     many different kinds of bacteria may infect the pancreas. This project uses molecular DNA~     techniques to help identify bacteria present in the pancreas of patients with severe~     necrotizing pancreatitis.~   "
94862|NCT01815463|"~     Hypothesis:The Adnab-9 antigen is a predictive biomarker in individuals at risk of~     developing colorectal neoplasia.~      Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker~     of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker~     would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be~     recruited into the study. In phase 1, candidates would be defined as having increased CRC~     risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative~     Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low~     estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of~     effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional~     questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a~     diagnostic test would be critically determined using the outcome of the colonoscopic and~     other test results. The patients will be contacted through the mail and by word of mouth.~     Informed consent will be obtained before the samples are obtained. The participants are~     clinically defined as high-risk and therefore screening colonoscopy would be likely~     performed in any event. A number of assays for Adnab-9 are feasible including slot-blot,~     Western blot, and ELISA. Other stool studies include conventional fecal occult blood tests~     (FOBT or FIT) that will be performed in tandem. The investigators therefore began this~     method of collection and obtained consent from over 2000 patients with a similar overall~     compliance rate with FOBT screening procedures to that reported previously of approximately~     50%. Currently the study is no longer enrolling patients at the Detroit VA and is now~     finalizing data entry. Another 450 patients to be recruited at the Philadelphia VAMC.~   "
94863|NCT01815450|"~     The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to~     placebo for the treatment of moderate to severe acne vulgaris.~   "
94864|NCT01815437|"~     This study will evaluate how much vitamin D is present in a mushroom supplement. This~     supplement contains an extract from mushrooms that have been exposed to sunlight. The~     mushroom supplement will be compared to non-commercially available vitamin D supplements~     produced in a Goo Manufacturing Practices (GMP)-licensed facility.~   "
94865|NCT01815424|"~     The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and~     10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks~     of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are~     candidates for systemic therapy or phototherapy.~   "
94866|NCT01815411|"~     Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to~     significant pain, joint destruction and functional decline, and has a substantial economic~     impact both for sufferers and society. Although the etiology of RA is unknown, it is~     generally accepted that it arises from an interplay of genetic predisposition (in~     particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological~     deregulation (e. g. autoantibody production), and environmental factors. The prevalence and~     incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and~     incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key~     pathogenetic factors in RA and these patients have elevated cytokine levels in joints and~     blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most~     important is premature cardiovascular disease that significantly contributes to increased~     mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold~     higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10~     years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic~     glucocorticosteroids, traditional disease modifying antirheumatic drugs (including~     methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL~     6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint~     replacement surgery and in need of rehabilitation.~      However, the treatment opportunities are still not optimal. In a large proportion of the~     patients, full control of the disease is not possible due to limited effect of available~     therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new~     therapeutic alternatives to treat RA.~      Since studies on healthy volunteers and IBD-patients support that the mushroom extract~     AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in~     a pilot study whether this effect also was evident in patients with RA. A potential~     anti-inflammatory effect could prove beneficial in these seriously ill patients, who~     accordingly could experience less side effects (edema, granulocytopenia, diminished tissue~     repair) due to potential reduction number and dose of disease modifying drugs.~   "
94867|NCT01815398|"~     Many young people who are homeless have cognitive deficits which impede their ability to~     secure and maintain employment. This study looks to see if targeting cognitive deficits can~     improve cognition and vocational outcome.~   "
94868|NCT01815385|"~     Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life~     exposure to an adverse developmental environment, including environmental toxins, are linked~     to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the~     mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong~     evidence suggests that alterations in the epigenome play a critical role in this process.~     The central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene~     leads to epigenetic changes which will have functional consequences and may be a marker for,~     or may contribute to, increased susceptibility to adverse outcomes in childhood including~     increased adiposity and the subsequent development of obesity, metabolic syndrome or~     diabetes. The goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical~     cord blood of newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy~     correlates with early onset of obesity and metabolic disease by examining the children at 12~     and 24 months of age, 3) determine whether in utero benzo[a]pyrene exposure programs~     metabolic disease through alterations in DNA methylation and gene expression, and 4)~     determine the plasticity of the DNA methylation patterns in the same offspring at 12 months~     of age. The long-term goal of this project is to define biomarkers that identify neonates at~     high-risk for diminished attainment of full health potential, who can then be targeted for~     preventative measures.~   "
94869|NCT01815372|"~     Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal~     level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following~     leg surgery. Traditionally two separate injections are performed. The aim was to describe a~     novel, faster USG block combination requiring only one skin penetration to block the sciatic~     and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.~      Methods: A randomized, controlled and double-blinded trial. Following ethics committee~     approval 60 patients will be randomized to the administration of an USG SPEDI block compared~     to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be~     performed after induction of general anaesthesia. Outcome measures will be performance time~     (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block~     difficulty level (easy, middle, difficult), opioid consumption (in the PACU),~     serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations~     will be evaluated by MR imaging (MRI).~      Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster~     without moving the leg, and achieve successful perioperative pain management. The SPEDI~     block may find important use in the emergency setting.~   "
97525|NCT01780519|"~     The investigators' goal is to determine if certain tests of memory and attention, performed~     while sleepiness is induced by a single dose of lorazepam, can predict whether or not an~     individual is at risk for developing Alzheimer's disease.~   "
94872|NCT01815333|"~     The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole)~     helps researchers most clearly to see cancerous lymph nodes on an MRI scan. Researchers~     also want to learn if ferumoxytole may be used in liver imaging.~      Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell~     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI~     contrast. Contrasts are used by doctors in order to see MRI images more clearly.~   "
94873|NCT01815320|"~     Acute allograft dysfunction is often observed in the first weeks after kidney~     transplantation. Renal biopsy is universally considered the gold standard procedure for~     differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes.~     Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover,~     it may but not contribute to clinical diagnosis in about 10% of cases because of the~     impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or~     readily applicable non-invasive procedures might therefore allow increasing the performance~     of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging~     technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in~     this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a~     surrounding phospholipid monolayer and last for several minutes in the systemic circulation~     before spontaneous degradation with absorption of the gaseous component by the lungs and the~     phospholipid shell by the liver. With the use of gasfilled microbubbles that act as~     scatterers within the blood stream and the development of low-MI ultrasound techniques that~     allow the visualization of the bubbles without destroying them, it is possible to improve~     the depiction of vessels and have access to structural and functional information on the~     microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used~     to evaluate kidney disfunction.~      Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be~     associated with different patterns of renal graft involvement during acute renal function~     deterioration and b. whether, conversely, different patterns of parenchymal perfusion~     detected by CE-US may help predicting different patterns of renal involvement will be~     investigated in 20 deceased or living donor kidney graft recipients.~   "
94874|NCT01815307|"~     To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after~     hemihepatectomy.~   "
94875|NCT01815294|"~     The purpose of this study is to support the qualification of a replacement manufacturing~     site for DOXIL/CAELYX (doxorubicin HCL).~   "
94876|NCT01815281|"~     The purpose of this research study is to evaluate safety and effectiveness of Foot~     Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and~     Progressive Supranuclear Palsy both stable and with motor fluctuation.~   "
94877|NCT01815268|"~     The purpose of this study is to prospectively evaluate relative effectiveness of high dose~     influenza vaccine in preventing influenza mortality, hospitalization, and functional decline~     in a nursing home population in the U.S., compared to the standard dose trivalent seasonal~     influenza vaccine.~   "
94878|NCT01815255|"~     This study will assess the safety and efficacy of generic TDF from Governmental~     Pharmaceutical Organization (GPO) in HIV-infected children~   "
94879|NCT01815242|"~     The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either~     carboplatin or gemcitabine for patients with triple negative breast cancer.~   "
94880|NCT01815229|"~     Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal~     lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique.~     Specimen samples obtained by wall suction will be collected at 2 time points following~     intubation.~      Blood samples will be obtained at 2 time points, simultaneous with the collection of the~     tracheal specimens.~   "
94881|NCT01815216|"~     After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former~     preponderance in relative short time (~ 2 years). But knowledge of the underlying biological~     mechanisms of decline in body weight is still inadequate.~      This project intends to examine patients' background activity in the brain (i.e. the~     resting state activity) and brain volume using MRI both before and one year after surgery.~   "
94882|NCT01815203|"~     With the abundance of energy-dense foods that are designed for ease of consumption in the~     current environment, it is of importance to better understand the factors that may undermine~     the control of energy intake at healthy levels.~      One of the factors that is potentially important in response inhibition is caffeine.~      The aim is to assess the direct effects of caffeine on response inhibition, using a No~     Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as~     pictures, modulate response inhibition different in restrained vs. non-restrained eaters.~   "
94883|NCT01815190|"~     Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a~     disease frequently seen by general practitioners and dermatologists. The clinical symptom is~     palpable purpura with predilection for the lower legs.~      In some cases vasculitis also affects systemic organs, such as the kidneys and the~     intestine.~      When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic~     involvement, the disease has been referred to as Henoch Schönlein purpura.~      When there are no signs of systemic involvement, the disease has been referred to as~     cutaneous leukocytoclastic angiitis.~      The investigators hypothesize that palpable purpura with predilection for lower legs is a~     pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and~     IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to~     be associated with systemic involvement and therefore warrants more extensive diagnostic~     procedures Vice versa the investigators postulate that the presence of IgG or IgM without~     IgA in immune complexes excludes systemic involvement The investigators also want to~     investigate to which of the 2 groups patients with palpable purpura and negative~     immunofluorescence should be assigned.~   "
94884|NCT01815177|"~     Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to~     arthroscopic suture anchor.~      This novel technique that allows surgeons to perform a standardized arthroscopic~     transosseous (anchor free) repair of rotator cuff tears can improve postoperative pain and~     reduce the incidence of shoulder stiffness.~      The aim of the this study is to compare clinical outcomes of two groups of patients:~     patients that received an arthroscopic transosseous fixation using the ArthroTunneler~     tunneling device (Tornier Inc, Edina, Minnesota) versus patients that received an~     arthroscopic rotator cuff repair using suture anchors.~   "
94909|NCT01814826|"~     This study is an open-label, multicenter, phase 1b, dose-escalation study of MLN4924 in~     combination with azacitidine in adult patients with AML. The patient population will consist~     of patients 60 years of age or older, previously diagnosed with World Health~     Organization(WHO)-defined AML, who are unlikely to benefit from standard induction therapy~     and who have not received definitive treatment for AML or prior treatment with azacitidine~     or decitabine.~   "
94885|NCT01815164|"~     Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this~     therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational~     intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44~     women with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen~     level dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI)~     during expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal~     distensions. Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational~     intervention (EDU). 31 patients completed the treatments and the post treatment fMRI.~     Results: Similar symptom reduction was achieved in both groups. HYP responders demonstrated~     a pre-post treatment BOLD attenuation in both anterior and posterior insula during high~     intensity distension, while EDU responders had a BOLD attenuation in prefrontal cortex.~     Pre-post differences for the low distension and for the two expectation conditions were~     almost exclusively seen in the HYP group. For all responders there was a significant~     correlation between treatment induced reduction of GI related anxiety and BOLD decrease in~     the anterior insula. Following treatment, the brain response to distension was similar to~     that observed in HCs, suggesting that the treatment had a normalizing effect on the central~     processing abnormality of visceral signals in IBS. Conclusions: The abnormal processing and~     enhanced perception of visceral stimuli in IBS can be normalized by psychological~     interventions. Symptom improvement in the treatment groups may be mediated by different~     brain mechanisms.~   "
94886|NCT01815138|"~     This a prospective randomized double blind study involving patients at high risk of OHSS~     development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in~     patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant~     hCG 1,500 IU 35 hours after GnRH agonist trigger.~   "
94887|NCT01815125|"~     Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present~     persistent symptoms at one week post injury. A systematic review showed a paucity of studies~     for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has~     shown promising results based on clinical experience and a single retrospective study.~     Objectives: The primary objective of this pilot study is to determine the feasibility of a~     randomized controlled trial evaluating the effect of ondansetron to decrease post concussion~     symptoms at one week following mTBI in children. More specifically, this pilot study will~     evaluate the proportion of participants who complete assessment at one week following~     intervention. Method: This will be a randomized, double blinded, controlled trial performed~     among children aged between 8 and 17 years old who sustained a mTBI in the previous 24~     hours. Participants visiting the emergency department will be randomized to receive one dose~     of either ondansetron or placebo. The primary outcome of interest is defined as an increase~     from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom~     Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full~     recovery, mean PCSI score, and outcomes at one month following head trauma. The primary~     analysis will compare the proportion of participants with persistence of symptoms at one~     week in both groups. The full study sample size was calculated to have 90% power to detect a~     decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of~     0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators~     plan to recruit 30 participants (10% of the final population) for the pilot study. Expected~     results: This pilot study should confirm the feasibility of the randomized controlled trial~     by showing that 90% of the recruited participants provide data on the primary outcome at one~     week following intervention. On the long term, the investigator expect that ondansetron will~     decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to~     lower than 30%.~   "
94888|NCT01815112|"~     The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus,~     the search for objective markers of preclinical first signs of cognitive impairment, is~     currently a major public health issue. Early detection of the disease is a major challenge~     to hope to slow or even stop the neurodegenerative process before the stage of dementia.~      In AD the investigators observe:~        -  A reduction in the volume of brain hippocampi associated with an alteration of the~          diffusion of water molecules in the white matter.~        -  A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.~      Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to~     dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to~     conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that~     aim,the investigators use two imaging modalities:~        -  Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain~        -  Positron emission tomography (PET) is used to assess glucose metabolism in grey/white~          matter and also in choroid plexus.~      The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be~     altered as well as glucose metabolism dynamic in choroid plexus.~   "
94889|NCT01815099|"~     We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS)~     for patients with GAD who were placebo nonresponders in DIEF003523.1.~   "
94890|NCT01815086|"~     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive~     monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by~     PET/CT imaging in patients with AL amyloidosis.~   "
94891|NCT01815073|"~     The purpose of this study is to observe the occurrence of adverse events and seroconversion~     rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE~     vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine,~     respectively.~   "
94892|NCT01815047|"~     The goal of this study is to characterize the function and efficacy of the bioactive~     nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The~     three specific aims of this study are 1) To address the impact of maternal vitamin D status~     on inflammation and infections across pregnancy using retrospective data, 2) To address the~     impact of vitamin D supplementation on maternal vitamin D status, inflammation and~     infections across pregnancy using prospective data and 3) To assess the impact of maternal~     vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.~   "
94893|NCT01815034|"~     Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and~     fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing~     arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic~     respectively)~   "
94910|NCT01814813|"~     This randomized phase II trial studies how well giving vaccine therapy with or without~     bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be~     removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a~     person's own tumor tissue may help the body build an effective immune response to kill tumor~     cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them. It is not yet known whether giving vaccine~     therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.~   "
94894|NCT01815021|"~     Primary objective:~      Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC~     compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0~     mg/dL).~      Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from~     ACC compared to CCS can maintain target serum calcium (corrected for albumin) values~     (7.0-10.0 mg/dL).~      Secondary objectives:~      Phase I~        -  ACC dose selection - to confirm the conversion factor of ACC from CCS~        -  To determine the effect of food on ACC absorption~      Phase II~        -  To test the hypothesis that treatment with smaller doses of elemental calcium from ACC~          compared to CCS will not cause an increase in hypercalciuria in patients with~          hypoparathyroidism~        -  To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the~          side effects related with high calcium consumption.~      Amorphical has a strong basis to believe that the ACC product is better absorbed compared to~     the commercially available CCS products and therefore, can maintain desirable target albumin~     corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As~     results, the burden of taking high doses of calcium supplementation along with the side~     effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be~     reduced.~      Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a~     straightforward method to test this hypothesis.~      The study is designed to be conducted with extra precaution in order to avoid disturbing the~     fragile balance between CA levels in serum and calcium levels urine. The crossover design of~     phase II of the study allows a more accurate and reliable comparison of results attributable~     to the specific treatment within the same individual. In addition, the subjects will~     continue consuming all their routine medication throughout the trial. The subjects in the~     control arm will consume their routine calcium supplement doses thus, will be treated with a~     standard of care.~   "
94895|NCT01815008|"~     This clinical trial is examining the role of genetic polymorphism on the effect of~     clopidogrel (with or without aspirin) on platelet response in persons at high-risk for~     myocardial infarction or stroke due to family history of early-onset coronary artery~     disease.~   "
94896|NCT01814995|"~     Women with a history of 'diabetes in pregnancy' or Gestational Diabetes (GDM) have a high~     risk for type 2 diabetes later in life. This can often be prevented, however, with~     improvements in eating habits and higher physical activity levels. However, many women find~     it difficult to alter their lifestyle habits, especially if they have young children. In~     adults with type 2 diabetes, the investigators have been studying the effects of combining~     nutrition education with meal preparation training and pedometer-based self-monitoring to~     improve eating habits and increase activity levels. The investigators have shown that such a~     strategy can reduce hemoglobin A1C by 0.3% and correlates with small reductions in weight~     (Dasgupta et al, International Journal of Behavioural Nutrition and Physical Activity,~     2012). In developing the present interventional study, we presented this strategy to women~     with a GDM history and asked them how they would modify it to suit their needs. They~     expressed strong interest in such an approach but emphasized a need to involve their spouses~     and provide childcare support. They did not express interest in use of meal replacements.~     Therefore, in MoMM-intervention phase, the investigators will examine the effects of a once~     per month (4 session) program combined with Internet/telephone-based support. The four~     sessions with include meal preparation training, strategies to limit mindless eating and~     improve meal content and portion control. All sessions will offer child care. Two sessions~     will involve spouses. The investigators will assess effects on weight, BMI, DXA measures of~     fat, and measures of insulin resistance and blood pressure. This single-arm intervention~     study may lead ultimately to a randomized controlled trial.~   "
94897|NCT01814982|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores~     what the body does to the drug) and pharmacodynamics (the study of the action or effects a~     drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and~     chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain~     stem).~   "
94898|NCT01814969|"~     Clinical objective of the study is to compare the rates of pathologic response, acute~     toxicity and sphincter preservation with two schedules of preoperative regiment in patients~     with locally advanced rectal cancer.~   "
94899|NCT01814956|"~     Aim is to investigate the influence of an early supply of parenteral nutrition including a~     fish oil containing lipid emulsion on the course of acute lung injury in the intensive care~     unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will~     be used. Data obtained in this trial may provide evidence for a beneficial effect of fish~     oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute~     lung injury.~   "
94900|NCT01814943|"~     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained.~     The aims of the post hoc analyses are:~      To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA~     for secondary prevention of vascular disease and the relative risk of UPU associated with~     use and discontinuation of use of low dose ASA.~      To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users~     of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other~     risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention~     of vascular disease.~   "
94901|NCT01814930|"~     Postpartum contraceptive counseling varies widely in its provision; no standardized practice~     has been well-established by the literature. We intend to evaluate how directed postpartum~     contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects~     will be randomized to receive either the standardized contraceptive counseling intervention~     or routine postpartum care. We will then assess the difference in repeat pregnancy rates~     between the two groups~   "
94902|NCT01814917|"~     The Primary Objectives of this study are to assess the long-term efficacy of treatment with~     colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of~     treatment with colestilan (MCI-196) (including combination therapy).~   "
94903|NCT01814904|"~     The Primary Objective of this study is to determine the initial starting doses of colestilan~     (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with~     Hyperphosphataemia.~   "
94904|NCT01814891|"~     Determination of liver stores of vitamin A will be determined before and after consumption~     of high pro-vitamin A orange maize, compared to low provitamin A white maize.~   "
94905|NCT01814878|"~     The purpose of this study is to compare the efficacy and safety of extended release (ER)~     tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol~     HCl/acetaminophen in participants with moderate to severe (very serious, life threatening)~     postoperative pain.~   "
94906|NCT01814865|"~     This study is being offered to patients who are post-menopausal, have breast cancer with a~     positive estrogen and/or progesterone hormone receptor test and are currently awaiting~     surgery for breast cancer.~      The purpose of this study is to determine whether abiraterone acetate has different hormonal~     and genomic effects than non-steroidal aromatase inhibitors in the treatment of~     post-menopausal hormonal receptor positive primary operable breast cancer~   "
94912|NCT01814787|"~     Increasing rates of type 2 diabetes among children and adolescents has considerable~     long-term implications not only for the affected individuals, but also for society and the~     health system as a whole. Pediatricians have unique and important opportunities to screen~     for type 2 diabetes and to promote lifestyle modification for those children identified with~     pre-diabetes; yet implementation of these practices within the pediatric primary care~     setting is far from ideal. The purpose of this study is to implement the ADA screening~     guidelines for type 2 diabetes and clinical management prompts within a pediatric primary~     care setting using a computer decision support system (CDSS) developed by the investigators~     research group - the Child Health Improvement through Computer Automation (CHICA) system.~     The investigators hypothesize that the coupling of CDSS with ADA guidelines will result in~     greater compliance with ADA recommended screening procedures as well as better clinical~     management of children identified as having pre-diabetes or type 2 diabetes.~   "
94913|NCT01814774|"~     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins~     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of~     Cervical Dystonia and Blepharospasm in clinical practice.~   "
94914|NCT01814761|"~     This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle~     glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated~     intraocular pressure (IOP).~   "
94915|NCT01814748|"~     This study will examine the safety and efficacy of once-weekly omarigliptin in participants~     18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The~     study hypothesis is that treatment with omarigliptin compared with placebo provides greater~     reduction in hemoglobin A1c (A1C) in participants after 24 weeks.~   "
94916|NCT01814735|"~     Currently, India has the largest absolute number of people with diabetes in the world, and~     evidence indicates that consumption of whole-grains can decrease diabetes by improving~     glycemic control. Our study will evaluate the efficacy of substituting brown rice, a~     whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk. The ultimate~     goal of this research is to provide data for use in designing a global dietary intervention~     study aimed at reducing diabetes risk through simple, culturally appropriate, feasible and~     sustainable dietary changes.~   "
94917|NCT01814722|"~     This is a multi-center, longitudinal observational study of adult human immunodeficiency~     virus (HIV) participants at academic and community-based practices in the United States who~     are switching from first-line to second-line therapy. The study's primary hypothesis is that~     HIV participants switching to raltegravir-based regimens will have better Medical Outcomes~     Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside~     reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.~   "
94918|NCT01814709|"~     This open-label, two-arm, drug interaction study will investigate the effect of~     co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy~     volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers~     will receive GDC-0032 and itraconazole. The anticipated time on study treatment is~     approximately 30 days.~   "
94919|NCT01814696|"~     The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted~     medication adherence device and reminder system, on medication adherence and clinical~     outcomes in heart-failure (HF) patients. We will also evaluate the usability and~     satisfaction derived from using this system.~      We hypothesize that:~        1. The use of the MedSentry system will improve medication adherence in patients with a~          discharge diagnosis of HF.~        2. The improvement in adherence correlates with fewer hospitalizations and emergency~          department (ED) visits.~        3. The improvement in adherence correlates with better health-related quality of life.~   "
94920|NCT01814683|"~     The main determinant of primaquine efficacy is the total dose of primaquine administered,~     rather than the dosing schedule. Previous trials have demonstrated that the standard low~     dose regimen of primaquine (3.5 mg/kg total) fails to prevent relapses in many different~     endemic locations. For this reason the 2010 WHO antimalarial guidelines now recommend a high~     dose regimen of 7 mg/kg (equivalent to an adult dose of 30mg per day), although many~     countries still recommend lower doses for fear of causing more serious harm to unscreened~     G6PDd patients.~      Shorter courses of higher daily doses of primaquine have the potential to improve adherence~     and thus effectiveness without compromising efficacy. Primaquine also has relatively weak~     but clinically relevant asexual stage activity against P. vivax so larger daily doses may~     substantially augment chloroquine's blood stage activity at low levels of resistance. In~     Thailand directly observed primaquine (1mg/kg/day) administered over 7 days was well~     tolerated and reduced relapses by day 28 to 4%. This is encouraging but not definitive since~     many relapses present after one month. Longer follow-up is needed to distinguish whether~     relapse was prevented or deferred. If the efficacy, tolerability and safety of short-course,~     high-dose primaquine regimens can be assured across the range of endemic settings, along~     with reliable point-of-care G6PDd diagnostics, then this new primaquine regimen would be a~     major advance in malaria treatment improving adherence to and thus the effectiveness of~     anti-relapse therapy.~      Due to the long duration of standard primaquine treatment regimens, courses are difficult to~     supervise, are poorly adhered to and lack effectiveness. This proposed multicentre~     randomised clinical trial will provide evidence across a variety of endemic settings on the~     safety and efficacy of high dose-short course primaquine in G6PD normal patients. In a~     parallel single arm study the investigators will also gather safety data on the use of~     weekly primaquine in patients with G6PDd. This study aims to generate evidence that will~     directly inform global public health policy for the radical cure of P. vivax. A better~     understanding of the risks and benefits of primaquine is crucial in persuading policy makers~     and clinicians of the importance of the radical cure of vivax malaria that will reduce the~     parasite reservoir and decrease transmission.~   "
94921|NCT01814670|"~     A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in~     Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated~     with facial laser resurfacing.~   "
94942|NCT01814397|"~     Postmenopausal women who have hormone receptor positive breast cancer are typically treated~     with aromatase inhibitor medications, which substantially decrease the amount of estrogen~     produced by their bodies. These medications are fairly well tolerated, but can cause aches~     and pains which can be quite severe in some cases.~      People experience pain differently. Estrogen appears to play a role in how we experience~     pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others.~     The goal of this study is to evaluate perception of pain in women with breast cancer, and to~     determine if differences in pain perception lead to more aches and pains in some women~     treated with aromatase inhibitors.~      In this study, we plan to enroll 55 women with breast cancer who are starting treatment with~     an aromatase inhibitor. Participants will undergo testing to evaluate their perception of~     pain, and will also complete a set of questionnaires. Testing will be conducted before~     starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will~     investigate whether pre-existing differences in pain perception lead to different amounts of~     pain during aromatase inhibitor therapy.~   "
94922|NCT01814657|"~     This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are~     studying the best way to control pain during the egg retrieval process. The egg retrieval~     involves passing a needle under ultrasound guidance through the vagina into the ovaries to~     remove eggs that are to be later fertilized. Patients often report this as very~     uncomfortable.~      Different fertility clinics across the country use different methods of pain control. All~     clinics will use intravenous medication to control pain, while some may or may not use local~     anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain.~     Since local anaesthetic injection involves multiple needle punctures and may be painful, the~     investigators are unsure if local anaesthetic is necessary in addition to the intravenous~     pain medication.~      The investigators will conduct a randomized trial where all patients will receive~     intravenous pain medication, but some will receive local anaesthetic injection and some will~     receive placebo injection. Patients will be asked to complete a questionnaire on their pain~     experience after oocyte retrieval. The investigators will then analyze the data and~     determine whether local anaesthetic actually improves pain when patients are already~     receiving intravenous pain medications. Through our study, the investigators aim to improve~     the pain experience of all women undergoing IVF in the future.~   "
94923|NCT01814644|"~     This project will test the efficacy of the TRIMM (Tailored Rapid Interactive Mobile~     Messaging) program, a user‐friendly, semi‐individualized text-messaging intervention to~     facilitate lifestyle change and weight loss among obese African-American adults with or at~     risk for diabetes, in a pilot, controlled clinical trial.~      The text-messaging intervention will be in addition to, and compared with traditional diet,~     behavior, and physical activity education. Tips will be designed to increase knowledge,~     skills, and motivation.~   "
94924|NCT01814631|"~     The primary objective for this study is to compare the image quality of two endoscopic~     ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to~     make a correct clinical diagnosis and higher quality imaging is related to more accurate~     results. Patient care may be improved due to the information collected as part of this~     study.~      The quality of imaging is of utmost importance for diagnosing early neoplasms in the~     pancreas and diseases such as chronic pancreatitis. Image quality is dictated by two~     factors: image resolution and depth of penetration. Good imaging enables diagnosis of early~     stage disease and thereby facilitates early treatment.~   "
94925|NCT01814618|"~     The purpose of this study is to determine if a trial of directed high-dose nasal steroids~     improves residual smell loss in patients with chronic rhinosinusitis following sinus~     surgery. Other outcomes of this study include: identifying the differences in sinus airflow~     between patients who improve following nasal steroid treatment and those who do not, and to~     see if, in patients who improve following surgery, the improvement remains throughout~     follow-up.~   "
94926|NCT01814605|"~     A new ultrasound-guided subgluteal space approach to sciatic nerve block that has been~     recently described obviates the need to identify the sciatic nerve. The investigators~     hypothesize that the use of an ultrasound-guided subgluteal space injection to perform~     sciatic nerve block will increase the proportion of patients experiencing complete sensory~     block in both terminal branches of the Sciatic nerve in comparison to the same proportion in~     those who receive the block via ultrasound-guided infragluteal approach with circumferential~     injection in patients scheduled for unilateral TKA(total knee arthroplasty) surgeries.~   "
94927|NCT01814592|"~     The aim of this study is to evaluate the effectiveness of total root coverage between two~     coronally positioned flap technique in Miller recession Class I and II, in patients~     attending at Universidad El Bosque dental school clinics.~   "
94928|NCT01814579|"~     This study is designed to determine if using the V-Loc Wound Closure System expedites~     operative time in robotic hysterectomy.~   "
94929|NCT01814566|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in January 2013.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart~     disease and angina pectoris in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
94930|NCT01814553|"~     This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the~     use of diarrheal management tools intended to facilitate timely intervention and treatment~     modifications due to afatinib treatment-related diarrhea in patients with EGFR~     mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea~     management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day~     of afatinib treatment.~   "
94931|NCT01814540|"~     The purpose of this study is to elucidate tolerability and effectiveness in consumption of~     the complex indigestible sugars from dairy products called bovine milk oligosaccharides~     (BMO) to enrich intestinal microflora toward beneficial populations.~   "
94932|NCT01814527|"~     Concussions are defined as a complex pathophysiological process affecting the brain, induced~     by traumatic biomechanical forces. Currently the standard of care in the treatment for~     concussions is cognitive and physical rest until symptoms resolve with a graduated return to~     activity. High dose omega-3 fatty acids have shown to have anti-inflammatory, anti-oxidant,~     and membrane stabilizing properties. They have also been used in treatment of severe~     traumatic brain injury. The purpose of this study is to determine if early high dose omega-3~     fatty acid supplementation in Division I National Collegiate Athletic Association (NCAA)~     athletes that have sustained a concussion will decrease the number of days out of~     competitive sports with a quicker symptom resolution, return to baseline neurocognitive~     functioning and postural stability using a randomized double blind placebo controlled study~     design. Once an athlete is identified as having sustained a concussion by the East Carolina~     University Sports Medicine staff and qualifies for the study, he/she will randomly be~     assigned to either high dose omega-3 fatty acid or placebo. Both groups will undergo~     standard and usual care for concussed athletes at East Carolina University. The number of~     days it takes the athlete to return to competitive athletics will be recorded, along with~     time to symptom resolution, normalization of their computerized neurocognitive testing~     (ImPact) and computerized postural stability testing (Biodex BioSway).~   "
94933|NCT01814514|"~     The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus~     maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device~     (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The~     hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by~     the hypertensive period where the IOP tends to rise steadily above 21mmhg.~      The hypertensive response seems to occur more commonly after Ahmed GDD surgery than~     nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the~     hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks,~     when there is intense congestion of the bleb wall, that IOP is highest.~      Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's~     capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue~     growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators~     induce an inflammatory reaction, and if excessive, will result in fibrosis and poor~     functioning of the bleb. High pressure within the bleb also results in the secretion of TGF~     β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis~     and poor bleb function. The investigators supposed that with early use of aqueous~     suppressant medication after AGV implantation, the concentration of inflammatory mediators~     decreased in subconjunctival space and may lead to better IOP control after shunt surgery.~   "
94934|NCT01814501|"~     This phase II trial studies how well panitumumab and combination chemotherapy works in~     treating patients with metastatic colorectal cancer previously treated with combination~     chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving panitumumab and combination chemotherapy together may~     kill more tumor cells~   "
94935|NCT01814488|"~     The experimental treatment consists in the application of a therapeutic strategy of~     allogeneic transplantation as a potential curative procedure in a population of patients~     with chemoresistant acute leukemias.~      Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are~     based on regimens currently in standard use in the context of allogeneic transplantation.~   "
94936|NCT01814475|"~     This study will be performed as a prospective multicenter phase II trial for compare~     busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC~     regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of~     myelofibrosis.~      The primary endpoint for this study is to compare Progression Free Survival of two different~     RIC regimens for allogeneic stem cell transplantation in myelofibrosis.~      Progression Free Survival is defined as the time from the date of randomization to the date~     of the first documented disease progression or relapse (according to the International~     Working Group Consensus Criteria) or death due to any cause. Patients who have neither~     progressed nor died at the time of study completion or who are lost to follow-up are~     censored at the data of the last follow up for progression of disease for this study.~   "
94937|NCT01814462|"~     The present study aims to document and assess changes in single parameters of pulse wave~     analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment~     before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with~     obstructive sleep apnea.~   "
94938|NCT01814449|"~     The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole~     (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT and expression of~     HIF-1-alpha could predict response of primary endocrine therapy in ER-positive breast cancer~   "
94939|NCT01814436|"~     Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem~     Cells from Human Exfoliated Deciduous Teeth~   "
94940|NCT01814423|"~     Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous~     research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95%~     efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of~     CQ is increased. Severe adverse events are caused by high peak concentrations of CQ. Using~     split doses of CQ avoids high peak concentrations enabling the safe administration of high~     doses, however, pharmacokinetic data are lacking.~      Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg~     as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse~     events will be monitored. On day 1, children and their mother/guardian will be requested to~     stay at the health centre between 9 am and 6 pm.~      Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the~     inclusion criteria will be recruited into each study arm.~      Following the end of treatment, the children will be seen on the morning of day 7, 14, 21~     and 28.~      Any child wishing to withdraw during the treatment phase and any child with reparasitaemia~     during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine~     according to treatment guidelines in Guinea-Bissau.~      Final analysis will include a description of included children, proportions of adverse~     events and any serious adverse events, drug concentrations and their relation to adverse~     events, the proportion of children withdrawn or lost to follow up, the cumulative PCR~     corrected and uncorrected success and failure rates on day 28 and the proportion of early,~     late clinical and late parasitological treatment failures.~   "
94941|NCT01814410|"~     There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive~     performance and behavior in humans. The main objective of this study is to characterize the~     interactive effects of acute intravenous (IV) ethanol and nicotine administration on~     cognition and behavior in healthy smokers. The general hypothesis is that nicotine will~     attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative~     effects of ethanol.~   "
95018|NCT01813409|"~     The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in~     practice improvement, local population management, and efficient, successful participation~     in national quality programs. RCR integrates evidence-based quality measures aimed at~     improving care and drug safety for patients with rheumatoid arthritis, osteoarthritis,~     osteoporosis, gout and juvenile idiopathic arthritis.~   "
94943|NCT01814384|"~     Total knee arthroplasty represents over 70 000 surgical procedures per year in France,~     increasing about 10% each year since the early 1990s. Clinical experience shows a strong~     rate of success on pain relieve and improvement of knee articular function for these~     patients.~      Longevity of the implants had been proved to depend on the biomechanical design and~     implantation techniques, particularly the bone cuts during the surgery. To improve the~     precision of these cuts, the patient matched cutting blocks developed by Medacta company~     allows to adapt bone cuts to the patient anatomy improving the reliability of these~     procedure. A reduction of surgical time and bleeding would be another benefit expected with~     this type of ancillary. The objective of this study is to demonstrate the advantage of~     patient matched cutting blocks for total knee arthroplasty on realiability for both clinical~     and radiological criteria, morbidity reduction during and after the procedure and also a~     benefit on an economic point of view.~   "
94944|NCT01814371|"~     The purpose of this research study is to compare the effectiveness of commonly used~     decolonization treatments (application of mupirocin antibiotic ointment to the nose and~     bleach baths) when performed by individuals with a history of skin and soft tissue infection~     (SSTI) in the prior year (individualized approach) in comparison to decolonization of all~     household members (household approach) in an attempt to prevent Staphylococcus aureus skin~     infections. The investigators hypothesize an individualized decolonization approach will be~     equally as effective as a household approach to prevent SSTI.~   "
94945|NCT01814358|"~     Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel~     dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood~     vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in~     blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein~     effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in~     normal weight and obese adults. This study will investigate the efficacy of drinking a whey~     protein beverage prior to eating for improved daily blood sugar control in normal weight and~     obese adults in the real world. Also, the study will test this dietary approach to reduce~     blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24~     normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects~     will wear a sensor to monitor daily blood sugar changes in response to their typically~     consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the~     monitoring period for measurement of blood vessel function after eating a breakfast cereal~     meal. Blood samples will be obtained before and after the meal to measure relevant health~     markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a~     week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin~     protein (control) shake prior to each meal. Neither subjects nor researchers will know which~     protein (double blind). Subjects will receive the alternate protein intervention after~     another week or more (crossover). We think drinking the protein shake prior to meals will~     reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction~     that results from eating the breakfast cereal.~   "
94946|NCT01814345|"~     Gastric cancer remains a major health issue and a leading cause of cancer death worldwide,~     although the prevalence and mortality of the disease have gradually decreased. The~     investigators have very few options for patients with advanced disease.~      The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of~     patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the~     efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median~     overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs.~     11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The~     survival benefit was most pronounced in the subgroup of high HER-2/neu protein~     overexpression (median overall survival of 16 months). Only 20% of the patients screened and~     subsequently enrolled for this study were found to be HER2-positive when utilizing both~     immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced~     gastric cancers and type III oesophageal adenocarcinomas.~      Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100~     patients with IHC and FISH in 2+ and 3+ patients.~   "
94947|NCT01814332|"~     This purpose of this study is to look at the safety of the experimental drug GSK561679 as~     well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress~     hormones, and mental health symptoms in comparison to placebo (an inactive substance).~   "
94948|NCT01814319|"~     Probenecid is an FDA approved drug for the treatment gout and hyperuricemia. It has been~     used safely in humans for decades for this and other indications. The investigators have~     recently discovered that this drug can also stimulate other receptors in the heart and~     therefore improve its function. The hypothesis of this study is that probenecid can be used~     to improve the function of the heart and therefore the symptoms in patients with heart~     failure.~   "
94949|NCT01814306|"~     There is no significant difference about success rate of two devices.~   "
94950|NCT01814293|"~     This is a nonblinded randomized controlled trial which is a survey-based comparison between~     supportive treatments for symptom relief from pediatric upper respiratory infection (URI).~     The primary objective of this study is to determine if the use of handheld humidifier~     improves URI symptom scores and/or reduces use of over the counter medications compared to~     other supportive treatments for pediatric URIs (ie. OTC cold medications, room air~     humidifier). Study duration is approximately 1 year and the individual intervention is 4~     days.~   "
94951|NCT01814280|"~     Background:~      Medication reviews performed on admission to hospitals reduce medication errors; however,~     evidence of effect on morbidity and mortality is currently inconsistent. It is known that~     patients' risks of experiencing medication errors are dependent on both patient- and drug~     factors, e.g. age, co-morbidity, number of drugs, risk of side effects.~      Aim and hypothesis:~      The aim of this pilot study is to study acute medical patients' risk of getting a medication~     error based on an algorithm that takes into account both patient and drug related factors.~     Secondary, the investigators will explore whether our methods are applicable in a randomised~     controlled trial. The investigators will also decide the number of patients in a randomised~     controlled trial based on this pilot study.~      The hypothesis is that an algorithm that has already been developed can stratify patients~     according to their risk of experiencing a medication error.~      Methods:~      100 acute admitted patients will be risk stratified at admission (>8 hours after). The~     patients who have highest risks of medication errors will receive a medication review~     performed by either a clinical pharmacist or a clinical pharmacologist.~   "
94952|NCT01814267|"~     The aim of the study is to assess the cost-effectiveness of telemedicine in the care of~     chronic diabetic foot ulcers.~      Patients will be randomized into 2 groups: 1/conventional care group with iterative visits~     to diabetes specialist or 2/innovative care (telemedicine group).~      the health insurance system perspective is adopted.~   "
94953|NCT01814254|"~     Estimation of hydration state in dialysis patients is a major challenge in clinical~     practice. Although many methods have been studied, none have been established yet for~     clinical routine practice.~      The investigators have developed a method, using segmental and calf bioimpedance~     spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the~     FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially~     developed to measure whole body and segmental body fluid volumes but Hydra is approved only~     for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring~     change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used~     for simple measurement before, during and after dialysis. Preliminary results in clinical~     studies have shown that optimal hydration state of HD patients may be determined by the calf~     method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE~     (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a~     modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5~     kHz and 0.8 mA current instead of 100 kHz and 2 mA.~      The subjects of this study include a group of hemodialysis patients and a group of healthy~     controls. The healthy controls are used to identify a normal range within the healthy~     population for each method. Each hemodialysis patient will be studied twice in different~     hydration state. The study will not change the procedure of the patient's dialysis~     treatment. Since all devices are based on noninvasive bioimpedance technique, this study has~     minimal risk.~   "
94954|NCT01814241|"~     The purpose of this study is to attempt to understand how desensitization works in peanut~     allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify~     the early changes in the desensitization process the immune cells undergo to become~     desensitized to the peanut protein.~   "
94955|NCT01814228|"~     Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent~     aetiology of syncope in young people without apparent cardiac or neurological pathology. It~     is usually caused by inappropriately trigger-activated cardiac reflex which finally~     precipitates asystole, sinus bradycardia, or atrioventricular (AV) block [1]. Despite young~     patients affected by CNS have an excellent prognosis when electro-structural heart diseases~     are excluded [2], their quality of life may be seriously affected by recurrent episodes [2,~     3]. Cardiac pacing might help to control symptoms and therefore is considered in patients~     aged more than 40 years old with recurrent episodes and documented cardioinhibitory response~     [1, 4]. In young individuals, the role of cardiac pacing is dubious due to predicted~     frequent device substitutions and adverse ventricular remodeling over time. Recently,~     radiofrequency (RF) biatrial ablation of ganglionated plexi (GP) has showed promising~     results in the short and long-term treatment of reflex syncope, functional atrioventricular~     block, or sinus node dysfunction [5, 6]. Nonetheless, strong evidences are emerging about~     efficacy of transcatheter ablation limited to ganglionated plexi in the right atrium with~     the possibility to avoid side-effects related to left-sided procedures [6]~      Aim of study~      To evaluate in a large cohort of patients effectiveness and safety of gangliar transcatheter~     ablation in the right atrium to obtain atrial denervation and prevent CNS.~      Study population and methods~      Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be~     enrolled in the study.~      Inclusion criteria:~        -  age between 18 and 60 years~        -  3 syncopal episodes at least of likely CNS in the previous 2 years~        -  marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop~          recorder registration [7].~      Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV~     block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.~      Exclusion criteria:~        -  documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection~          fraction lower than 50%)~        -  documented tachyarrhythmias as possible causes of symptoms~        -  channelopathies (Brugada syndrome, LQT or SQT syndrome)~        -  ventricular preexcitation~        -  symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement~        -  pregnancy in women~        -  previous cardiac pacemaker implantation.~      After obtaining informed consent patients will undergo to basal electrophysiological study~     (EPS) to record AH interval, HV interval, Wenckebach cycle length, sinus node recovery time~     (SNRT) and correct sinus node recovery time (cSNRT); the same parameters will be recorded~     immediately after ablation. Following basal EPS an accurate (200 valid points at least)~     electroanatomic right atrium mapping (CARTO 3™ Biosense Webster, Inc) will be performed and~     subsequently radiofrequency delivered at right atrial anatomic sites where the underlying~     presence of ganglionated plexi (GPs) clusters was regarded as highly probable, on the basis~     of anatomical studies [8-11]: the supero-posterior area (superior right atrial GP, adjacent~     to the junction of the superior vena cava and the posterior surface of RA), the~     middleposterior area (posterior right atrial GP, posterior surface of the RA adjacent the~     interatrial groove), the infero-posterior area (inferior right GP placed between the~     inferior vena cava, coronary sinus ostium, and near the atrioventricular groove).~     Transcatheter ablation will be performed using an 8mm-tip catheter (Biosence-Webster~     Navistar DS 8mm) or an irrigated 4 mm-tip catheter with force control system (Biosence~     Webster Smarttouch). Ablation will be performed until complete elimination of local atrial~     electrical activity. Response to radiofrequencies delivery will be considered successful in~     case of asystolic pause or cardiac cycle lengthening of 30% (compared to basal cycle) at~     least. To prolong RF delivery despite asystolic response, a quadripolar catheter will be~     positioned in right ventricle to backup stimulation. To avoid phrenic nerve injury, high~     amplitude stimulation will be performed just before radiofrequency delivery to the superior~     right atrial GP.~      HRV analysis will be performed on admission, at 2 hour after ablation and patients~     discharge. The HRV analysis will include the following parameters: mean, maximal and minimal~     heart rate, SDNN (standard deviation of Normal-Normal), RMSSD (root mean square successive~     difference), pNN50 (percentage of differences between adjacent N-N intervals that are >50~     msec), LF (low frequency), HF (high frequency).~      Moreover, an HUT and an HRV analysis will be performed at 1, 3, 6 and 12 months after~     ablation procedure during the follow up.~   "
94956|NCT01814215|"~     The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home~     (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical~     activity and improve the diet quality of children (1.5 to 4.9 years).~   "
94957|NCT01814202|"~     The purpose of this study is to determine whether a medical nutrition product, PTM202, along~     with standard of care, enhances recovery and reduces diarrhea morbidity in young children~   "
94958|NCT01814189|"~     The purpose of this study is to show the efficacy of promethazine in management of patients~     with moderate to severe migraine~   "
94959|NCT01814176|"~     During Anesthesia many patients require that a breathing be inserted into their windpipe.~     This is usually achieved using a direct laryngoscope, consisting of a retraction blade with~     a light near its end. When achieving a direct line-of-sight to the windpipe is difficult,~     more force is often applied, resulting in greater patient stress. A GlideScope video~     laryngoscope uses a camera and light source to see the windpipe. This enables the user to~     see objects that may not be in the direct line-of-sight. This likely results in less force~     being required, reducing patient stress. Because such stresses are often confounded by~     patient variables, we are comparing the forces required by the direct and video~     laryngoscopes on patients with at least one risk factor for difficulty, by directly~     measuring these with special sensors attached to the laryngoscope blades.~   "
94960|NCT01814163|"~     This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line~     therapy in patients with non-squamous advanced non-small cell lung cancer.~   "
94961|NCT01814150|"~     Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including~     lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.~      One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.~      Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated~     with the outcome of docetaxel based therapy in cancer patients.~      The investigators aim to prospectively study the association between the plasma level of~     alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.~   "
94962|NCT01814137|"~     This trial is conducted globally. The aim of the trial is to compare efficacy of insulin~     degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD)~     versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in~     controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an~     extension to trial NN5401-3941 (NCT01680341).~   "
94963|NCT01814124|"~     Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and~     disability typically affecting the young adult, active population and has been identified as~     a precursor to hip osteoarthritis (OA). Common impairments include sharp, anterior groin~     pain in a position of hip flexion limiting patients' ability to tolerate prolonged sitting,~     squatting, stair climbing, etc. resulting in both work limitations and decreased social~     participation. Manual therapy and exercise is known to be effective in reducing pain and~     increasing physical function in the management of hip OA. To the extent that FAI is often a~     precursor to developing hip OA, logic would seem to dictate a manual therapy plus exercise~     approach to decrease pain and disability and potentially prevent or delay osteoarthritis~     related surgery. Currently, surgery is considered the first line of treatment with respect~     to FAI. However, there is a lack of evidence to support or refute the use of conservative~     treatment interventions in this patient population.~      This study is designed to investigate the benefits of physical therapy interventions (manual~     therapy and exercise) over usual care for improving pain and physical function in patients~     with FAI of the hip. For this study, 52 participants will be recruited from the Department~     of Orthopaedic Surgery, Wake Forest Baptist Medical Center, for an outpatient consultation~     for consideration of hip arthroscopy surgery. Participants will include those patients who~     meet clinical and radiological criteria for formal diagnosis of FAI. Participants will be~     randomized into two treatment groups. Participants in one group will receive usual care plus~     manual therapy directed at the hip as well as a supervised exercise program and home~     exercise program twice weekly for six weeks. Participants in the usual care group will~     receive usual care as prescribed by the physician. Changes in pain, physical function and~     benefits of the intervention will be assessed over six weeks. Should this research study~     demonstrate treatment effectiveness of physical therapy intervention in patients diagnosed~     with FAI of the hip, manual therapy plus exercise may have the potential to delay or prevent~     surgery in this patient population. Further, to the extent to which FAI has been shown to~     lead to later development of hip OA, effective treatment interventions may help to delay or~     prevent secondary osteoarthritis related changes as well as total joint replacement surgery~     associated with hip OA. This study will provide preliminary data that can be used to prepare~     further grant applications designed to determine the safest, most effective treatments for~     patients with FAI.~   "
94964|NCT01814111|"~     The purpose of this study is to demonstrate whether renal sympathetic denervation is safe~     and effective in patients with hypertension and paroxysmal atrial fibrillation.~   "
94965|NCT01814098|"~     The purpose of this study is to evaluate the efficacy and safety of long term escitalopram~     treatment in participants with Major Depressive Disorder (MDD) with associated anxiety~     symptoms.~   "
94966|NCT01814085|"~     The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment~     in participants with severe major depressive disorder (MDD [marked depression appearing in~     the involution period and characterized by hallucinations, delusions, paranoia, and~     agitation]).~   "
94967|NCT01814072|"~     The overall objective of the proposed research is to use an innovative methodological~     framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an~     optimized, scalable version of a technology-supported intensive lifestyle intervention~     (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the~     effects of individual treatment components, and thereby identify which components and~     component levels make important contributions to the overall program effect on weight loss.~     This information then guides assembly of an optimized treatment package that achieves target~     outcomes with least resource consumption and participant burden. Because the intervention~     strategies being tested minimize in-person coaching and leverage technology that~     participants already own, the new optimized intervention, to be called Opt-IN, will be more~     scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable~     significant progress in the fight against obesity.~   "
94968|NCT01814059|"~     Background:~        -  Eosinophil-associated gastrointestinal disorders (EGID) are a group of related~          disorders that affect the esophagus, stomach, and bowel. There are two major types of~          EGID, eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the~          body's immune system being activated by food allergens, which then damages the gut~          wall. People with EGID have large numbers of eosinophils (a type of white blood cell)~          in their gut. EGID can cause difficulty swallowing, abdominal pain, or nausea.~        -  At present, there are no drugs specifically approved to treat EGID. Most adults who~          have EGID receive steroid therapy to manage the symptoms. However, long-term steroid~          use may cause other problems in the body. Researchers want to see if low-dose sirolimus~          can be used to treat EGID. Sirolimus is a drug used to prevent rejection of~          transplanted organs. It may be able to keep the body's immune cells from being~          activated by food allergens and decrease the eosinophils.~      Objectives:~      - To see if low dose sirolimus is safe and decreases blood or gut eosinophils in EGID.~      Eligibility:~        -  Individuals between 18 to 65 years of age who have EGID.~        -  Participants must also have an elevated blood eosinophil count and positive blood tests~          for IgE antibodies to foods.~      Design:~        -  Participants who are on medicine for EGID or related symptoms must be on a stable dose~          for 1 month before screening and stay on that dose throughout the study.~        -  Participants will be screened with a medical history and physical exam, and review~          their symptoms. They will provide blood and urine samples. They will also have heart~          and lung function tests. Some participants may have allergy skin tests.~        -  At the first study visit, participants will have 2 days of inpatient tests. They will~          repeat the tests from the screening visit. They will also have a full analysis of the~          esophagus, stomach, and small intestine. On the second day, they will start to take~          sirolimus as a liquid with orange juice or water.~        -  Participants will continue to take sirolimus at home. They will record their doses and~          any symptoms. They will also have a visit to provide blood samples about 2 weeks after~          the first study visit.~        -  At the second study visit (about a month after the first visit), participants will~          repeat the tests from the screening visit. The sirolimus dose may be adjusted as~          needed.~        -  Participants will take sirolimus for at least another 28 days. Depending on the dose of~          the drug and the blood test results, some participants may need to take it for up to~          112 days. Those who take the drug for a longer period will have additional study visits~          with tests.~        -  There will be another study visit when participants stop taking the drug. The last~          visit will be a final follow-up visit.~   "
94969|NCT01814046|"~     Background:~      - The NCI Surgery Branch has developed an experimental therapy that involves taking white~     blood cells from patients' tumors, growing them in the laboratory in large numbers, and then~     giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes,~     or TIL and we have given this type of treatment to over 200 patients with melanoma. This~     study will use chemotherapy to prepare the immune system before this white blood cell~     treatment. After receiving the cells, the drug aldesleukin (IL-2) may be given to help the~     cells stay alive longer.~      Objectives:~      - To see if chemotherapy and white blood cell therapy is a safe and effective treatment for~     advanced ocular melanoma.~      Eligibility:~      - Individuals at least greater than or equal to 16 years to less than or equal to 75 years~     who have advanced ocular melanoma.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests~          as needed.~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
94970|NCT01814033|"~     The Null Hypothesis is that there is no significant change in range of motion (ROM), pain,~     or function for a group of patients following total knee arthroplasty (TKA) who use the LRU~     pillow as compared to a control group of total knee arthroplasty patients who do not use the~     pillow.~   "
94971|NCT01814020|"~     Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with~     fungal nail infection.~   "
94972|NCT01814007|"~     To evaluate if multiple same-day CoolSculpting treatments increase the risk of abnormal~     lipids and liver-related tests.~   "
94973|NCT01813994|"~     Statins are commonly used as cholesterol-lowering medications and have shown effectiveness~     in the primary and secondary prevention of heart attack and stroke. In addition, several~     recent studies of human cancer cell lines and animal tumor models indicate that statins may~     have chemopreventive properties through the arresting of cell-cycle progression. The~     chemopreventive effect of statins was demonstrated in some kind of human tumors including~     colorectal cancer. In addition, recent one large epidemiologic study showed that statins~     decreased risk of gastric cancer. On the other hands, it has been well known that~     Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are~     premalignant lesions of gastric cancer. Progression of these premalignant lesions could be~     limited by H. pylori eradication. In addition, a recent double blind randomization study~     revealed that simvastatin as adjuvant to standard therapy improves significantly the H.~     pylori eradication rate. Therefore, investigators conjecture that statins may have an~     adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the~     role of statins in gastric carcinogenesis by observing the changes of gastric inflammation~     under statins.~   "
94974|NCT01813981|"~     Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial~     vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids~     (CGA), however the level of CGA is reduced during the roasting process.~      The aim of this study is to investigate the effect of coffee roasting on vascular response.~     The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable~     vascular response over more heavily roasted coffee due to the higher levels of CGA.~   "
94975|NCT01813968|"~     Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven~     both in animal models and in humans. This study aims to investigate the effect of ischemic~     postconditioning on postoperative hemodynamic function in a standard heart surgery patient~     population.~   "
95116|NCT01812122|"~     The purpose of this study is to analyze the differences of blood sugar level and glycemic~     variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen~     number of type 2 DM patients. The investigators also reveal influences of each drugs on~     cardiovascular risk factors by measuring related biomarkers.~   "
94976|NCT01813955|"~     Phosphodiesterase (PDE) inhibitors represent a new group of potential antipsychotic~     compounds currently under development. One of these is papaverine, an inhibitor of the PDE~     10 family. The class of PDE10 inhibitors have been reported as possible candidates in the~     treatment of schizophrenia, and may prove an attractive antipsychotic alternative due to the~     many side-effects of the currently available antipsychotics. It has been proposed from~     preclinical studies that PDE10 inhibitors have the potential to reduce cognitive deficits in~     schizophrenia and these findings need to be confirmed in a human population, in view of the~     fact that no other currently registered drug posses these unique properties.~      The currently proposed project is designed to investigate whether the PDE10 inhibitor~     Papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients.~     In order to accomplish this effect, Papaverine will be investigated in schizophrenia, with~     regards to symptomatology, hemodynamic, neurocognition and early information-processing.~   "
94977|NCT01813942|"~     In order to perform research smoothly, the process of information extraction is required for~     translating data in clinical text into available format for analysis and statistic. In~     medical research, the problem of missing data occurs frequently. It is important to develop~     the method with better imputation performance in the stability and accuracy. The purposes of~     this project are to provide the data integration and extraction methods for handling the~     structured and unstructured data sources in more efficient ways, to provide the validation~     scheme for facilitating the data reviewing of extracted results produced by information~     extraction modules, to increase the quality of clinical data by comparing the data from~     different data sources and correcting data errors and inconsistent, to handle the clinical~     data with the properties of time series and incompleteness, to increase accuracy of data~     analysis and increase quality of health care by improving the completeness and correctness~     of clinical data, to provide flexibility of methods in the platform. In the project, the~     disease topic is focused on the liver cancer patients' clinical data and we hope the methods~     in the projects can be extended to handle other diseases by replacing these knowledge models~     in the future.~   "
94978|NCT01813929|"~     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk~     in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on~     insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D.~     The long term goal is to identify novel non-glycemic approaches to managing cardiovascular~     disease risk in T1D. The results of this study may validate a novel approach to T1D~     treatment that could significantly improve current management of cardiovascular disease risk~     in this high risk population.~   "
94979|NCT01813916|"~     The purpose of this study is to use the proteomic analysis of synovial fluid to perform the~     comprehensive investigation of the biomarker that will be useful to assign the tratment~     effectiveness of five weekly intra-articular HA injection.~   "
94980|NCT01813903|"~     The purpose of this study was to test internet and mobile-based applications to support~     motivating lifestyle counseling to promote healthy eating habits of the mothers and their~     spouses expecting first child. The feasibility of the intervention will be evaluated in the~     pilot.~   "
94981|NCT01813890|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol~     immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain,~     compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.~   "
94982|NCT01813877|"~     It was previously shown that 18F-DOPA PET imaging results in intended management changes in~     41% of brain tumor patients. However, its impact on patient outcome defined as survival,~     costs, and/or quality of life has not been demonstrated. Regulatory agencies require~     randomized trials to determine the impact of PET on patient management and outcome. In this~     study we hypothesize that the addition of 18F-DOPA PET will improve patient outcome by more~     accurately identifying presence or absence of tumor recurrence than conventional imaging.~   "
94983|NCT01813864|"~     The proposed Quality Improvement Initiative study is a health services research project in~     community-based substance abuse treatment programs. The primary goals are to use training~     and technology transfer to match services to client needs, increase the number of services~     received by clients, and improve client outcomes. This is a two phase study in which we~     compare clients pre-intervention to clients post-intervention.~      Clients from Phase II (Post-Intervention) compared to Phase I (Pre-Intervention) will:have~     treatment plans that better match the problems reported at assessment; receive services that~     better match their needs, as reported during the assessment/intake; show better results~     during treatment performance on the Treatment Services Review (TSR), including attending a~     greater percentage of their scheduled treatment sessions and increased satisfaction with the~     Treatment Planning process; show better client outcomes at 3 month follow-up on primary drug~     and alcohol measures, including Breathalyzer and urine drug screen, and secondary personal~     health and social functioning measures such as days medical problems, days psychiatric~     problems, days employed, days of conflict with family members, etc.~   "
94984|NCT01813851|"~     Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse~     outcome and low quality of life in chronic renal failure patients treated by dialysis.~     Treatment strategies of PEW by different types of nutritional support (as dietary~     counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited~     efficacy. Physical activity has been shown to have numerous positive impacts in pathologic~     conditions associated to end stage renal disease.~      Concomitant prescription of physical activity and nutritional support might mutually enhance~     the anabolic effects of these interventions and improve the rate of remission of PEW.~      The aim of this study is to analyze the effect of a programmed, progressive endurance~     training performed during the dialysis session on a cycle ergometer under the supervision of~     a qualified trainer, on protein energy wasting and physical functioning of chronic~     hemodialysis patients.~   "
95042|NCT01813097|"~     Patients with prostate cancer should have the following examination including biopsy, serum~     PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood~     biochemistry, blood rout, ECG and testosterone.~      Two groups:~      First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal~     prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection~     1/4weeks).~      Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg~     subcutaneous injection 1/4weeks).~      PFS and PSA level will be the primary variables.~   "
94985|NCT01813838|"~     A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute~     myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not~     responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a~     response:~      Patients will receive 6 treatment cycles unless disease progression, transformation, or~     unacceptable toxicity occurs, or the patient refuses to continue participating in the study.~      Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles,~     patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with~     cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort)~     until progression.~   "
94986|NCT01813825|"~     A registry is an observation database. Participation in this registry does not require any~     additional or different procedures or drugs other than those you would normally receive for~     breast cancer. Registry databases are used to identify trends in medical care that help the~     medical community identify optimal care for different diseases.~      The data will be compiled on the safety and performance of the Partial Breast Brachytherapy~     Applicator based on the information collected about the treatment and follow up visits.~   "
94987|NCT01813812|"~     This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase~     III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the~     non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic~     gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets,~     three times a day for two weeks.~   "
94988|NCT01813799|"~     This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in~     the treatment of pain associated with diabetic neuropathy. Subjects will receive either~     300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain~     score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and~     Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.~   "
94989|NCT01813786|"~     Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment~     of scars.~   "
94990|NCT01813773|"~     To assess the safety of intravitreal aflibercept injection in the treatment of proliferative~     diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.~   "
94991|NCT01813760|"~     The Diode laser system is being used in this marketing study for the treatment of wrinkles~     around the eyes and mouth.~   "
94992|NCT01813747|"~     The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to~     provide clinical outcome data for treatment of the mandibular and submandibular areas~     specifically for skin tightening and laser lipolysis.~   "
94993|NCT01813734|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the RET gene. This mutated gene may help cancer cells grow. Only participants with a~     RET mutation will be allowed to participate. In this study, investigators are testing the~     strategy of using a study drug designed to inhibit or shut off growth signals that results~     from the mutated RET gene.~      Ponatinib is an anti-cancer drug that has been used in research studies for other types of~     cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this~     research study, investigators are looking to see whether ponatinib is effective and safe in~     treating NSCLC harboring RET rearrangements.~   "
94994|NCT01813721|"~     This is a prospective observational study investigating how physicians assess the risk of~     febrile neutropenia (FN) developing in patients who will receive chemotherapy.~      Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and~     Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell~     lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast~     cancer and will be due to receive one of the specific chemotherapy regimens of interest.~      Investigators' approach to FN risk assessment will be studied using lists of possible risk~     factors they may consider during their assessment. Investigators will be asked to select and~     rank the factors they consider the most important when assessing the overall FN risk of a~     subject and when making the decision whether to treat with granulocyte-colony stimulating~     factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based~     initially on their own routine clinical practise and subsequently relating specifically to~     each subject recruited.~      This is a non-interventional study that involves no procedures outside normal care for the~     subjects; all data collection will be completed prior to chemotherapy administration.~   "
94995|NCT01813708|"~     200 type 2 diabetes patients will be randomly submitted to an intensive life-style or a~     collaborative educational programmes by means of random numbers list. The intervention will~     be conducted by certified nutritionists or certified diabetes educators, previously trained~     in behavioural modification and in self-care techniques. The intervention will last 16~     weekly sessions and A1c, LDL cholesterol, blood pressure will be measured as main variables.~     Furthermore, body weight and abdominal girth, other lipids (HDL cholesterol,~     triglycerides),and physical activity, quality of life, psychological well-being and~     self-efficacy will be measured with specific questionnaires for up to 6 months.~   "
94996|NCT01813695|"~     The purpose of this study is to see if testing for genes related to pain and pain management~     before surgery affects how patients are treated for pain after surgery. The investigators~     want to know if this information will be used to effectively treat patients for pain after~     surgery if the clinical staff have a chance to review it before the surgery.~   "
95043|NCT01813084|"~     RV1729 is a new medicine being developed for possible treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The main purpose of this study is to investigate the safety, tolerability and~     pharmacokinetics of single and repeat doses of RV1729.~   "
95117|NCT01812109|"~     Testicular torsion is the spontaneous twisting of the testis and its blood vessels,~     resulting in acute pain, vascular compromise and death of the testicle if unrelieved~     quickly. In this study, investigators will test a near-infrared spectroscopy (NIRS) device~     that rapidly and non-invasively measures deep tissue oxygen saturation.~   "
94997|NCT01813682|"~     The purpose of this study is to determine whether iron-fortified TPN is effective in the~     preventative and treatment of preterm infants. Preterm infants are at risk for anemia~     especially in preterm infants. Generally the smaller Birth weight and gestational age the~     higher anemia rate in infants. About 25% to 85% of preterm infants develop evidence of~     anemia during infancy，77% VLBW（very low birth weight） infants developed anemia during the~     hospital stay. The effects of iron deficiency are pervasive and involve multiple organ~     systems. Poor physical growth, gastrointestinal disturbances, thyroid dysfunction, altered~     immunity and temperature instability has been attributed to iron deficiency in very low~     birth weight infants. So it is important to provide iron for preterm infants.~      As enteral nutrition is not feasible soon after birth in most preterm infants, Parenteral~     iron administration is an efficacious method for us to select. For most preterm infants the~     use of TPN(total parenteral nutrition) is very common during the first ten days of life, so~     we hypothesis that iron-fortified TPN may have a preventative and treatment effect on~     preterm infants using TPN as a supplementation of oral nutrition; Iron-fortified TPN(total~     parenteral nutrition) can also improve iron store status of preterm infants. The higher~     concentration of iron used in this study the larger preventative or treatment effect on~     preterm infants anemia; It is safe to add Small dose of iron agent to TPN.~   "
94998|NCT01813669|"~     The purpose of this study is to examine whether an integrative group-based intervention will~     help children experiencing psychological and physical distress. Children, ages 10 to 12,~     will be recruited for participation in this therapeutic group. Eligible and consenting~     participants will be randomized to a wait-list control group or the group intervention. The~     group intervention will take place over a 12-week period, during which participants will~     attend a weekly coping skills group that integrates yoga-based practices (such as yoga~     poses, mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such~     as increasing awareness of thoughts and emotions).~   "
94999|NCT01813656|"~     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for~     methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have~     different pharmacological effects of neurotransmitters.To determine whether mirtazapine~     would reduce methamphetamine use among mehtamphetamine addicts.~   "
95000|NCT01813643|"~     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or~     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical~     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),~     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central~     dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are~     second generation antipsychotics，but have different pharmacological effects of antipsychotic~     treatment.This study was designed to examine the acute efficacy, safety, and tolerability of~     risperidone and aripiprazole for patients with MAP.~   "
95001|NCT01813630|"~     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.~   "
95002|NCT01813617|"~     Most patients respond to medical treatment with corticosteroids and immunosuppressive~     treatment, but a majority of patients develop sustained muscle impairment. The aim of this~     study was to evaluate the outcome of muscle endurance assessed with the Functional Index-2~     (FI-2), muscle strength assessed by the MMT-8 and disease activity assessed by the six item~     core set at 6 and 12 months following diagnosis in patients with polymyositis (PM) and~     dermatomyositis (DM).~      72 patients diagnosed with probable or definite PM or DM 2003-2010 who performed the FI-2~     and the MMT at the time of diagnosis were included in this Swedish Myositis Register study.~     All patients had performed both the Functional Index-2 assessing muscle endurance and the~     Manual Muscle test (MMT) assessing isometric muscle strength. Physician Global assessment~     based on the evaluation of the consensus recommended six item core set for disease activity~     assessment was also included. Data were analysed on group levels as well as with criteria~     for individual responder criteria. A responder was identified as improving at least 20 %~     compared to baseline.~   "
95003|NCT01813604|"~     This study is an open-label phase III randomized clinical trial that would compare~     immunogenicity after receiving one of five different combinations of polio vaccines. Infants~     will be enrolled and randomized at 6 weeks of age to one of five different arms:~      A) Three doses of trivalent oral poliovirus vaccine (tOPV) at 6, 10 and 14 weeks of age B)~     Three doses of bivalent OPV (bOPV) at 6, 10 and 14 weeks of age C) Two doses of~     intramuscular (IM) inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age D) Two~     doses of intra-dermal (ID) fractional IPV (f-IPV) at 6 and 14 weeks of age E) Sequential~     administration of ID f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age To assess~     the immunogenicity of each study vaccine and vaccination schedule, antibody titers against~     poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before~     (at 6 weeks of age) and after receiving 3 doses of study vaccine (18 weeks of age).~     Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally~     derived antibodies, assuming a half-life of 28 days. The initial antibody titer at 6 weeks~     of age will be used as the starting point for the expected decline in maternal antibody.~      This study will compare the immunogenicity of:~        1. Sequential dose of intra-dermal f-IPV and bOPV to bOPV alone administered at 6, 10 and~          14 weeks of age~        2. tOPV to bOPV administered at 6,10 and 14 weeks of age~        3. IM IPV to ID f-IPV administered at 6 and 14 weeks of age The answer to these questions~          will guide the global polio eradication program in designing new routine immunization~          schedule for children that eliminates the risks of paralysis due to vaccine derived~          poliovirus (VDPV) from type 2 vaccine poliovirus.~   "
95052|NCT01812967|"~     The investigators hypothesize that the physiological effects of milk on satiety and glycemic~     control are mediated by the interaction between its macronutrient components by both~     insulin-dependent and independent mechanisms.~   "
95118|NCT01812096|"~     Intravenous injection is the standard administration route of bortezomib; however,~     subcutaneous administration is an important alternative. We want to compared the~     pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose~     and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed~     patients of multiple myeloma.~   "
95004|NCT01813591|"~     This small study is to investigate the efficacy of Acthar in the treatment of chronic~     migraine in patients who have failed multiple treatments, including Botox (which is defined~     as having <30% reduction from baseline in the number of headache days per month). Despite~     the widespread use of anti-seizure medications, there remain a significant number of patient~     whose migraines are refractory to these agents. The pathophysiology of migraine is such that~     the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are~     released at the trigeminal nerve endings innervating the large cranial and dura mater blood~     vessels and this neurotrasmission generates migraine associated pain. Because of this,~     treatment for migraine can be directed towards down regulating those receptor sites~     accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown~     to inhibit the release of CGRP and may also provide relief through a negative feedback loop~     as exogenous ACTH inhibits CRH release and mast cell degranulation.~   "
95005|NCT01813578|"~     The hypothesis is that intensive aerobic and endurance muscle training is safe and~     beneficial in patients with systemic sclerosis and concurrent interstitial lung disease.~      The purpose of the study is to examine the effect of an eight week intensive aerobic~     exercise and muscle endurance training program for patients with systemic sclerosis and~     50-100 % of forced vital capacity.~      A single subject experimental design with repeated systematic measures during a six week~     A-phase (baseline period) and an eight week B-phase (intervention period) was used. Physical~     capacity (six minute walk test), aerobic capacity (submaximal treadmill test) and muscle~     endurance in shoulder and hip flexion (Functional Index 2) are assessed every other week~     throughout the 14 week study. Activity limitation (Health Assessment Questionnaire), quality~     of life (Short Form 36), Raynaud, Fatigue and Global Health during the recent week (Visual~     Analogue Scales) are assessed at weeks 0, 6, 14. The exercise program includes aerobic~     exercise corresponding to 15 on the Borg RPE scale (strenuous) and muscular endurance~     training three times/week.~   "
95006|NCT01813565|"~     The purpose of this study is to evaluate efficacy and safety of additional hyaluronic~     acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with~     interstitial cystitis.~   "
95007|NCT01813552|"~     This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or~     omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and~     tolerability of the study drugs when administered alone and in combination in healthy~     participants.~   "
95008|NCT01813539|"~     The purpose of this study is to determine the recommended Phase 2 dose of ARGX-110, an~     antibody that binds CD70, in patients with advanced malignancies.~   "
95009|NCT01813526|"~     Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based~     medical food will be evaluated for 42 days.~   "
95010|NCT01813513|"~     The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food~     on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential~     PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on~     the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high-~     versus low-fat meals on the PK of IDX719.~   "
95011|NCT01813500|"~     The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are~     chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium~     difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A~     and B and is increasing faster in IBD patients, than the general population. Clinically, CDI~     in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to~     severe life threatening colitis, colectomy and death.~      This pilot study will look at the relationship between IBD and this variable host immune~     response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the~     IBD population than in the general population. In the general population, high antitoxin~     titers have been linked with colonization and low antitoxin titers with recurrent disease.~     The investigators hypothesize that patients with IBD will have a lower Clostridium difficile~     colonization and will have lower antibody titers than the control group. Additionally those~     with lower titers will have an increased risk of developing CDI.~      In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool~     study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls).~     In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to~     controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate~     the incidence of CDI in patients with IBD compared to controls and associations with~     anti-toxin titers.~   "
95012|NCT01813487|"~     The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in~     combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.~   "
95013|NCT01813474|"~     The objective of this study will be to investigate the safety and tolerability of olaparib~     tablet when given orally to Japanese patients with advanced solid malignancies. In addition,~     the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be~     investigated.~   "
95014|NCT01813461|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole~     and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.~   "
95015|NCT01813448|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will~     also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in~     healthy Japanese and Caucasian subjects.~   "
95016|NCT01813435|"~     After a stent procedure, it is common practice to prescribe anti-platelet medication to~     prevent the blood from clotting. The main objective of this study is to determine if there~     is a better medication strategy to prevent blood from clotting and at the same time~     minimising the number of complications.~      There are two medication strategies:~        -  Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month,~          and then ticagrelor alone for another 23 months OR~        -  Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or~          clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely~   "
95017|NCT01813422|"~     This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab~     (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week~     78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.~   "
95019|NCT01813396|"~     First, the purpose of the first year study will examine the joint capsule/muscular and~     shoulder physical activity hypotheses related to ROM deficits as well as functional~     disability in subjects with Stiff shoulders. Second, the purpose of the second and third~     year study will investigate the long-term effect of 12-week joint mobilization, 12-week~     joint mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization~     plus soft tissue mobilization/massage with appropriate shoulder physical activity guide on~     subjects with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders~     will be recruited. Second and third years: forty-five subjects with Stiff shoulders for one~     year follow-up. Methods: For the measurement outcomes; functional disability, rotation range~     of motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured~     by self-reported Flexi-level Scale of Shoulder Function or performance-based motion~     analysis, goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer,~     and accelerometers, respectively.~   "
95020|NCT01813383|"~     Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical~     and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.~   "
95021|NCT01813370|"~     The purpose of this study is to continue follow-up on patients who were treated on the study~     called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study~     early, before all patients have completed all planned follow-up tests. As a result, the~     investigators do not yet know whether hormonal therapy alone, or in combination with~     docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising~     PSA after prostatectomy. This study will continue following patients according to a schedule~     that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer~     that question. This study is known as a registry study. The patients' will not receive any~     treatment as part of this study. Instead, they will be asked to have a blood test performed~     once every 12 weeks.~   "
95022|NCT01813357|"~     This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with~     placbeo in HIV positive people who are at intermediate cardiovascular risk.~      It is possible that HIV positive people will receive a greater benefit from statins because~     of their higher baseline levels of inflammation. Current Australian guidelines recommend~     initiation of statin therapy on the basis of cholesterol level and the presence of other~     risk factors for heart disease (such as diabetes) but do not take into account whether a~     patient is infected with HIV. This study aims to determine what benefit HIV infected people~     will receive from starting statin therapy earlier then currently recommended.~   "
95023|NCT01813344|"~     Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens~     for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with~     high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment~     outcome of hyper-CVAD in LBL has reported only in small number of patients from single~     institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based~     treatment in LBL.~   "
95024|NCT01813331|"~     ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the~     adherence to the current therapeutic guidelines in a large series of patients affected with~     chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart~     failure among all the patients referring to the ambulatory cardiologists of the healthcare~     district.~   "
95025|NCT01813318|"~     Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused~     on treatment of co-occurring symptoms, including inattention, hyperactivity, and~     irritability that commonly occur in persons with ASD. Despite over two decades of~     significant pharmacotherapy research, to date no medication has been shown in controlled~     trials to enhance the core social deficits of ASD. Based upon findings describing the~     neurobiology of ASD combined with our preliminary results, we believe the novel drug~     acamprosate will show evidence of reducing social skills deficits associated with ASD.~   "
95026|NCT01813305|"~     The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with~     diabetic foot ulcers.~   "
95027|NCT01813292|"~     HIV+ patients are considered at risk for excessive bone fragility. Several factors could~     contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D~     deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is~     used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed~     as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine~     (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone~     formation by stimulating osteoblasts, of often impaired bone quality.~      The aim of the study is to compare in a cross-sectional design fluoride levels, bone~     renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for~     more than 60 months. The patients will be randomly selected, then matched according to age,~     ethnic origin, BMI.~   "
95028|NCT01813279|"~     Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral~     responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are~     excessive severity of the disease. This condition can affect the hands with a major~     functional consequence severely impairing the quality of life of patients.~      Adipose tissue is used in plastic surgery for over a century for the filling of depressions~     in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue~     was noted. It is shown that the stromal vascular fraction is responsible for this~     regenerative effect.~      In a previous study the investigators have demonstrated in a mouse model that the~     subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the~     fibrosis of the dermis and providing a pro angiogenic.~      Objectives and means:~      This is a clinical study evaluating an innovative cell therapy procedure. The objective of~     this study was to evaluate the effects of injection of autologous stromal vascular fraction~     of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United~     Kingdom) in digital in patients with scleroderma cutaneous hands.~      Eleven patients with scleroderma with the hands will be included in the study. Due to the~     nature of the orphan disease, a longitudinal study be conducted, where each patient will~     have own control.~      The evaluation will be pre and post operative for a period of six months. This evaluation~     will be based on clinical criteria (trophic balance, functional) and laboratory~     (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue).~      Project schedule and implementation phases:~      The project will run over a period of twelve months. Patients will be followed for a period~     of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved~     over a period of six months.~      Expected Results: This study will validate the functional and trophic effects of reinjection~     of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients~     with scleroderma.~      Conclusion: This innovative cell therapy could represent an alternative treatment for~     patients with scleroderma in check, intolerant or insufficiently relieved by medical~     treatment currently available in the scleroderma hand~   "
95029|NCT01813266|"~     Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more~     commonly progresses to chronic hepatitis. The acute process is most often asymptomatic.~     Acute HCV typically leads to chronic infection. Chronic HCV infection is usually slowly~     progressive. Approximately 5 to 20 percent of chronically infected individuals develop~     cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic~     liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for~     liver transplantation in the United States.~      Screening for chronic HCV infection is crucial because chronic HCV infection is often~     asymptomatic, effective treatment is available, and untreated disease carries a high risk of~     morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening~     do not all agree. All guidelines recommend screening patients at increased risk for HCV (ie:~     typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC)~     recommended screening all persons born between 1945 and 1965. At least two studies suggest~     that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is~     cost-effective. The studies estimated that if patients found to be HCV positive were treated~     with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with~     HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening~     based upon a birth cohort in patients without risk factors may lead to more false positive~     results.~      Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by~     Intermountain Healthcare providers have been screened. Ambulatory care physicians are not~     effectively screening patients. It is unclear whether screening based on risk factors alone~     versus screening based upon risk factors and birth cohort most effectively manages the~     burden of chronic HCV infection for patients managed by Intermountain Healthcare providers.~     It is possible that the Intermountain Healthcare population differs in risk from the U.S.~     population,making guideline application less certain.~      A well-designed prospective cohort study is needed to understand the risks and benefits of~     different HCV screening strategies on diagnostic yield and clinical outcomes.~      The investigators hypothesize that screening based on a person's history of risk factors~     will detect chronic HCV infection in 2.7 % of the population tested; this would be according~     to national average. The investigators further hypothesize that screening based on birth~     cohort and risk factors will identify roughly the same percentage in the tested population.~     The investigators anticipate usable data within three months which should give us data to~     describe and publish the effectiveness of different screening strategies.~      The investigators will identify patients with chronic HCV infection through this initial~     study who now require treatment and management. The investigators believe this group could~     be followed inexpensively for clinical endpoints for many years. This would then~     definitively define the effectiveness of screening strategies based on good evidence. No~     study has evaluated clinical outcomes associated with the different screening strategies for~     chronic hepatitis c virus infection.~   "
95030|NCT01813253|"~     This study will evaluate overall survival of nimotuzumab in combination with irinotecan~     compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or~     gastroesophageal junction cancer.~   "
95031|NCT01813240|"~     Spinal cord trauma and the consequent paraplegia are possibly among the most devastating~     injuries in soldiers and during spine surgery, and are significant in the medical, social~     and financial aspects. Limited mobility, the need for assistance in all human activities,~     shame, and many medical complications related directly to the neural deficits make~     paraplegia an important target for prevention. Our study will evaluate the efficacy of~     Minocycline in two different groups:~        1. Minimizing the neurological damage among trauma patients.~        2. Preventing neurological damage through operation in spinal tumors patients.~      2.OBJECTIVES~      The primary objectives of the trial are to determine:~        1. Efficacy of administrating minocycline in minimizing the neurological damage among~          acute spinal cord injury patients and spinal cord tumors (primary and metastases)~          patients?~        2. Efficacy of administrating minocycline at changing the natural history and~          rehabilitation of spinal cord trauma patients.~        3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?~   "
95032|NCT01813227|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     study drug called carfilzomib. The investigators want to find out what effects, good and/or~     bad, it has on patients and their cancer if treatment continues beyond previous carfilzomib~     treatment study.~      Carfilzomib (KyprolisTM) is approved by the U.S. Food and Drug Administration (FDA) to be~     used only in certain U.S. patients with relapsed and refractory multiple myeloma that have~     tried and failed other therapies. It has not been approved to be used for any other disease~     or condition.~      In this study, carfilzomib is referred to as an investigational study drug because it is not~     approved for use in all patients with multiple myeloma in the United States, and it is not~     approved by some regulatory authorities (the agencies that are responsible for approving the~     use of a medicine in a country such as Health Canada).~      Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found~     within cells that has the important role of identifying and marking damaged proteins that~     are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows~     for damaged protein to accumulate within cells. This accumulation of damaged protein causes~     the cell to die.~   "
95033|NCT01813214|"~     This study is for patients with malignant melanoma which has spread beyond the local area~     and cannot be surgically removed, and who have melanoma tumors that are accessible for~     repeat biopsies. This research study is a way of gaining new knowledge about treatment~     options for metastatic melanoma. This research study is evaluating the effects of the drugs~     vemurafenib and cobimetinib on the immune system.~      Vemurafenib has been approved by the FDA for treatment of patients with advanced melanoma~     that harbors a B-RAF mutation. Vemurafenib works by blocking a protein called B-RAF.~     Researchers have found that a large number of melanomas have mutations (changes) in the BRAF~     gene. Genes are specific parts of your DNA that contain information on hereditary~     characteristics such as hair color and eye color. The BRAF gene codes for a protein called~     B-RAF, which is involved in sending signals in cells that can lead to cell growth. Research~     has determined that mutations in the BRAF gene at the V600 position cause a change in the~     B-RAF protein that can drive the growth and spread of melanoma cells.~      Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2,~     central components of the RAS/RAF pathway.~      The purpose of this research study is to determine how vemurafenib and cobitmetinib may~     alter the immune system's reaction to melanoma, in order to learn how best to combine immune~     therapies with vemurafenib in the future.~   "
95034|NCT01813201|"~     The purpose of this clinical trial is to determine whether intermittent administration of~     testosterone against placebo is associated with a reduction of mortality and heart failure~     hospitalizations at 1 year, in male patients with advanced heart failure and testosterone~     deficiency.~   "
95035|NCT01813188|"~     The purpose of this clinical trial is to check the non-inferiority and lower morbidity of~     the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate,~     for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous~     bone graft.~   "
95036|NCT01813175|"~     This study is initiated to investigate the effect of infant formula with added specific~     synbiotics mixture on proportion of beneficial bacteria.~   "
95037|NCT01813162|"~     The purpose of the study is determine if the local release characteristics and systemic~     exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by~     concomitant use~   "
95038|NCT01813149|"~     40 CRPS patients will be recruited over a three-year period (target of 160 patients at all~     sites). Assessment of exclusion criteria will be undertaken during initial recruitment.~     Exclusion criteria are: <18 years; a second chronic pain syndrome that would interfere with~     pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or~     breastfeeding; sympathectomy in the affected limb; use of topical medication; known~     sensitivity to alpha 1- adrenoceptor agonists or other contraindications. Patients will~     maintain their regular oral medications throughout the study period.~      Assessment of sympathetically maintained pain (SMP) will require an intradermal dose of~     Phenylephrine to rekindle SMP and mechanical hyperalgesia. Clonidine will be used to control~     for affects of lgometer iction and may inhibit SMP by inhibiting the release of more~     norepinephrine from sympathetic nerve terminals. Skin biopsies will be obtained under~     sterile conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter~     skin biopsy punch under local anesthesia. Samples from a mirror image site on the~     contralateral body side will also be taken.~   "
95039|NCT01813136|"~     The objective of this study is to determine the feasibility of pazopanib treatment~     interruption with reintroduction at progression in iodine refractory progressive~     Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous~     administration.~   "
95040|NCT01813123|"~     This study is designed to develop and test a gender-specific, web-based drug abuse~     prevention program. Study participants will be adolescent girls aged 13 and 14 years who~     will complete all measures online. Randomly assigned girls will also interact online with a~     skills-based program and subsequent annual booster sessions.~      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower~     among girls assigned to receive the intervention.~   "
95041|NCT01813110|"~     The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate~     inflammatory responses to endotoxin challenge.~   "
95044|NCT01813071|"~     This is a research study about an experimental (investigational) oral Shigella sonnei~     (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which~     causes bloody, watery diarrhea. Infants and children living in developing countries~     experience the greatest consequences of this disease. The purpose of this study is to find a~     dose of the vaccine that is safe, tolerable, and develops an immune response. About 39~     healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this~     study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in~     the children. This study will require volunteers to stay in the research facility for~     several nights for the first dose; they will not be required to stay overnight for the~     second and third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels~     by mouth. Study procedures include: stool samples, blood samples and documenting side~     effects. Participants will be involved in study related procedures for about 8 months.~   "
95045|NCT01813058|"~     Adolescent idiopathic scoliosis surgery is an extensive procedure associated with~     significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA)~     is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to~     extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial~     and orthopedic surgery. In this prospective randomized double-blinded study, the~     investigators wish to evaluate the hypothesis that TXA is more effective than standard of~     care at decreasing blood loss and blood transfusion perioperatively in children and~     adolescents undergoing idiopathic scoliosis surgery.~   "
95046|NCT01813045|"~     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible~     for cardiovascular disease. In this proposal, the investigators intend to build upon a~     highly successful programme of studies exploring the cardiovascular applications of positron~     emission tomography. Specifically, the investigators will explore the potential role of a~     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and~     αvβ5 integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and~     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic~     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here~     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,~     specifically acute myocardial infarction and aortic atherosclerosis. The investigators will~     correlate 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis. If~     successful, this novel radiotracer could provide an extremely important non-invasive method~     of assessing in vivo angiogenesis, plaque vulnerability, and tissue remodelling as well as~     potential applications in developing stem cell therapies.~   "
95047|NCT01813032|"~     Emergency Service Professionals have an increased risk of death from heart attacks when~     compared to the general public. All the emergency professions share similar responsibilities~     such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty~     death amongst fire-fighters accounting for 45% and compared with 22% in police officers and~     15% in the general population. The unique risk to fire-fighters is likely to reflect a~     combination of factors including extreme physical exertion, mental stress, heat and~     pollutant exposure.~      In this study the investigators will assess healthy career fire-fighters and age-matched~     healthy police officer control subjects following a sedentary period. The investigators will~     take blood samples to measure platelet activity (platelets are the particles in blood that~     help blood clot) and will examine how blood clots outside of the body. The investigators~     will then perform studies placing small needles in the arm to assess how the blood vessels~     respond following these duties. The investigators hypothesise that fire-fighters do not have~     pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of~     their occupation, but rather these are acute and transitory effects following distinct~     fire-fighter duties. We therefore expect similar results in both occupational groups.~   "
95048|NCT01813019|"~     The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can~     have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive~     Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at~     appropriate doses).~   "
95049|NCT01813006|"~     Background~      Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad~     cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease~     even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated~     fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease,~     however its effect on patients with FH is not known.~      The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to~     inflammation measured in the blood and the effect on the blood vessels`ability to relax~     (endothelial function) by means of tonometry.~      Hypothesis~      Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the~     endothelial function, and the treatment will also lead to a decrease in in several markers~     of inflammation and in lipids in the blood.~   "
95050|NCT01812993|"~     Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke~     (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce.~     Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled~     randomized sequential phase studies currently exist that aim to establish the efficacy of~     early non-invasive ventilation in AIS patients. The main hypothesis for this study is that~     early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP)~     positively affects short-term clinical outcomes in AIS patients. This is a multicenter,~     prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients~     with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be~     randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated~     within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and~     nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to~     assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS~     at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional~     outcomes are assessed as secondary endpoints by un-blinded and blinded observers~     respectively. This study will provide data to power a subsequent phase III study.~   "
95051|NCT01812980|"~     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in~     HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic~     reactions to the vaccine will also be assessed.~   "
95053|NCT01812954|"~     This study is health economic analysis of medicinal treatment options for moderate-to-severe~     psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes~     will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for~     moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various~     different sources, including summary of product characteristics (SPCs) and the German S3~     guideline on psoriasis care, health care utilization data and official statistics.~      The study aims to investigate the comparative cost-effectiveness of biologic and~     conventional systemic treatments currently (as of June 1st, 2012) approved for~     moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means~     of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs~     Direct cost as well as indirect cost will be considered.~   "
95054|NCT01812941|"~     The purpose of this project is to evaluate the level of mitochondrial dysfunction several~     patient populations: Burn, trauma, and control group of healthy volunteers.~      Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory~     mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction~     syndrome in severly injured patients.~      As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial~     dysfunction.~   "
95055|NCT01812928|"~     Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting~     in urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria~     (blood in urine).~      Pain associated with cystoscopy varies from patient to patient, majority requires local~     anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of~     topical anesthesia and duration of cystoscopy are recognized as important factors~     contributing in severity of pain of which use of intraurethral gel left to individual~     preference. Various studies are available reporting the pain perception with use of various~     intraurethral gels. Even the highest level of evidence is unable to resolve the query.~      With this study the investigators hypothesize that pain perception (recorded in form of pain~     score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non~     Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.~      With better control of pain the investigators aim to increase patient comfort and compliance~     which will increase the patient satisfaction rate and early return to work.~   "
95056|NCT01812915|"~     When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff~     hyperinflation of the endotracheal tube. Furthermore the difference among various types of~     cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.~      TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study,~     the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with~     cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical~     study is needed to evaluate the intracuff pressure during general anesthesia with nitrous~     oxide exposure.~   "
95057|NCT01812902|"~     Prostate cancer is currently the second most common cause of cancer death in men in Western~     countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and~     is classically indicated in intermediate and high risk prostate cancer patients and is held~     at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the~     obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph~     node involvement outside the traditional boundaries of classical lymphadenectomy,~     recommending therefore extended dissection; this also includes the external / internal /~     common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would~     also has a therapeutic role, besides helping in better staging. Although some retrospective~     studies report an association between lymphadenectomy and tumor progression, the exact~     impact of extended lymphadenectomy in oncological outcome of patients with prostate cancer~     is not clearly established, mainly by lack of prospective randomized studies on the subject~     . The study objectives are to compare the oncologic results of extended lymphadenectomy~     versus limited in order to elucidate the role of extended dissection in lymph node staging~     and results of treatment in terms of increased tumor cure. The investigators also intend to~     identify patients who may benefit from oncologically extended procedure. To do this, the~     investigators will evaluate prospectively patients diagnosed with prostate cancer at~     intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These~     patients will be randomized to the extended versus limited lymphadenectomy and the~     investigators will compare the lymph node metastasis and pattern of spread of prostate~     cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis~     and cancer-specific survival.~   "
95058|NCT01812889|"~     The purpose of this study is to determine the safety, local tolerability and pharmacokinetic~     parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females~     following single dose administration (Part 1), and in nonpregnant women with vaginitis~     following multi-dose administration (Part 2).~   "
95059|NCT01812876|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in December 2012.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      The purpose of this study is to make a cohort event monitoring to see whether and how~     Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.~   "
95060|NCT01812863|"~     The purpose of this study is to determine if US-guided supraclavicular anesthetic blocks~     reduce postoperative pain, use of rescue medication, and improve functional outcomes in~     children who underwent surgery for supracondylar humerus fractures.~   "
95061|NCT01812850|"~     The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night~     muscle activity in an objective manner, in addition to daytime bruxism and clenching, as~     reported by the patient, following the start of orthodontic treatment with Invisalign®. A~     baseline evaluation of all measures will be used as control data, while different time~     points will be used to evaluate the evolution of patients' symptoms over the course of six~     months (the duration of the study).~   "
95062|NCT01812837|"~     The global aim of this study is to investigate how microneedles can facilitate the~     penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses~      The specific aims are as follows:~        1. Investigate whether pretreatment with microneedles enhances penetration of topical~          aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA~          pharmaceuticals Inc.~        2. Investigate whether pretreatment with microneedles can decrease the required incubation~          times of the topical ALA prior to exposure to blue light photodynamic therapy.~   "
95086|NCT01812525|"~     Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with~     no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of~     hospital stay will be analyzed.~   "
95953|NCT01801163|"~     This is a research study of a radiation treatment called stereotactic body radiotherapy~     (SBRT) plus a medicine called sorafenib. The purpose of this study is to evaluate the safety~     of SBRT plus Sorafenib to see what effects (good and bad) it has on the treatment of liver~     cancer.~   "
95063|NCT01812824|"~     This study is to examine the effectiveness of a health communication system (Gabby) that~     assesses preconception health risks and tailors the intervention to each subject, based on~     her health risks.~      There is a need to develop practical tools that can be used to identify preconception health~     risks and will facilitate the initiation of intervention for these risks; this project~     specifically targets young Black or African American women in order to reduce major~     disparities in birth outcomes. Clinicians do not have time to assess for over 100~     preconception health risks that can impact birth outcomes; this system can streamline that~     assessment and create a personalized list of risks. Patients can then share their list with~     clinicians to make their healthcare visits more effective.~      This study involves a pilot of the system through the Preconception Peer Educator (PPE)~     Program, which is a program created by the Office of Minority Health. The program began in~     historically black colleges in the United States, with the purpose of training students to~     reach out to their community to educate about the increased risk of preterm birth, low birth~     weight and infant mortality among African Americans. The PPEs teach about preconception~     health, or getting healthy before pregnancy, to increase the chances of having a healthy~     baby. Now the PPE program has expanded to colleges in over 20 states across the country.~   "
95064|NCT01812811|"~     The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2~     diabetic patients who had two 24 hour measurements performed within one week with the~     Arteriograph24 equipment.~   "
95065|NCT01812798|"~     An important gap in the management of peanut allergy is that we do not know the threshold~     dose, below which most peanut allergic individuals will not react. There is likely a~     spectrum of reactivity to peanut where some individuals react to trace doses, whereas others~     are able to tolerate larger doses. The purpose of this study is to determine the minimum~     threshold dose needed to cause a mild objective reaction when peanuts are consumed by~     peanut-allergic individuals in a carefully controlled clinical setting. 30 peanut-allergic~     participants aged 7-65 years will undergo a two-day, double blind placebo controlled food~     challenge. Participants will be gradually fed increasing amounts of peanut, or placebo,~     until objective allergic symptoms are observed. Statistical modelling of individual~     threshold doses will be used to determine a population threshold dose, or a level of peanut~     to which 90% of the peanut-allergic population will not react. Knowledge of threshold doses~     at an individual and population level is valuable in that it provides critical information~     for the management of peanut allergy by individuals, their caregivers and health~     professionals, as well as knowledge of allergen risks to public health agencies and the food~     industry.~   "
95066|NCT01812785|"~     The goal is to improve the evidence-based management of fever cases seen in outpatient~     clinics in malaria endemic countries, through a better understanding of the value of~     accurate malaria diagnosis, and through an improved understanding of the other causes of~     fever in children. The objective is to describe systematically (as much as possible) the~     etiologies of fever in children in an urban and in a rural environment of sub-Saharan~     Africa.~   "
95067|NCT01812772|"~     RESEARCH QUESTION Do ureteric stents with tethers, left in-situ for 1-2 weeks, increase the~     rate of stent bacterial colonization, urinary bacterial colonization and stent related lower~     urinary tract symptoms compared to stents without tethers?~      HYPOTHESIS We hypothesize that ureteral double-J stents with tethers increase the rate of~     stent bacterial colonization, but do not increase the rate of urinary bacterial colonization~     or stent related lower urinary tract symptoms compared to stents without tethers when left~     in-situ for 1-2 weeks.~   "
95068|NCT01812759|"~     The goal of this clinical research study is to learn if fentanyl nasal spray can help~     decrease pain related to cancer when used with other drugs for pain. Researchers also want~     to know if this drug can help decrease the length of your stay in the Emergency Department.~      In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is~     not a drug. It looks like the study drug but it is not designed to treat any disease or~     illness. It is designed in this study to be compared with the study spray to learn if the~     study spray has any real effect.~      You will also be given intravenous (IV) pain drugs. You will be given these drugs even if~     you decide not to take part in this study.~   "
95069|NCT01812746|"~     The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with~     metastatic castration-resistant prostate cancer (mCRPC).~   "
95070|NCT01812733|"~     The objective of the non-interventional study is to compare the quality of life, health care~     resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq)~     versus oxycodone and laxatives for patients with severe pain, and to evaluate the~     cost-effectiveness of treatment with Targiniq.~   "
95071|NCT01812720|"~     This phase II trial studies how well carfilzomib and dexamethasone work in treating patients~     with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and~     increase blood cell counts. Giving carfilzomib together with dexamethasone may be an~     effective treatment for multiple myeloma.~   "
95072|NCT01812707|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein~     convertase subtilisin/kexin type 9 (PCSK9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL~     (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment~          in comparison with placebo~        -  To evaluate the safety and tolerability of alirocumab~        -  To evaluate the development of anti-alirocumab antibodies~        -  To evaluate the pharmacokinetics of alirocumab~   "
95119|NCT01812083|"~     The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene~     polymorphisms may be associated with PLBW. Smoking has been well documented by numerous~     studies as a major environmental risk factor for periodontitis and adverse pregnancy~     outcomes. Therefore, the investigators only selected non-smoking individuals in this study~     as the smoking-related risk could obscure the polymorphism-related increase in risk for~     periodontitis and adverse pregnancy outcomes. This study aimed to determine the association~     between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy~     outcomes and periodontitis in a non-smoking Turkish population.~   "
95073|NCT01812694|"~     Background:~      - LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is~     studying pregnant women who are overweight or obese. It is looking at ways they can manage~     their weight gain in pregnancy and how this may affect them and their babies health at birth~     and through the first year. Researchers want to recruit pregnant women who are being treated~     at the Phoenix Indian Medical Center. They will participate in a two-part study.~      Objectives:~      - To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical~     Center.~      Eligibility:~        -  Pregnant women at least 18 years of age who are overweight or obese.~        -  Participants must be receiving care at the Phoenix Indian Medical Center.~        -  Participants must be having only one child in their pregnancy (no twins or other~          multiple births).~      Design:~        -  This study will have two parts. The first part will have three visits to obtain data~          about health early in pregnancy. It will also let participants and researchers find out~          if the participants are eligible and should continue in the second part of the study.~          In the second part, participants will be monitored throughout their pregnancy and~          during the first year after the baby s birth to test the effects of a lifestyle~          intervention to control weight gain during pregnancy.~        -  On the Part 1 study visits, participants will have a physical exam and medical history.~          They will provide blood, urine, hair, and other samples to be examined for possible~          genetic conditions.~        -  For the Part 2 study visits, participants will be placed in one of two treatment~          groups. Each group will receive the same prenatal and postnatal care that they would~          get if they did not join the study.~        -  The first group will have a lifestyle intervention program. They will spend about 2~          hours every week with other members of their group to learn diet and activity behaviors~          that may help with their health.~        -  The second group will have an enhanced care program. They will be given additional~          information about health and pregnancy and be invited to attend three classes to learn~          about staying healthy during pregnancy.~   "
95074|NCT01812681|"~     Experimental and observational studies have shown that vitamin D deficiency may be~     associated with an increased risk for non-bone diseases and/or abnormal development for the~     other systems of fetus. The aim of this study is to determine the relationship between cord~     blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities~     including RDS, PDA, NEC, BPD AND ROP in preterm infants.~   "
95075|NCT01812668|"~     This pilot clinical trial studies cabozantinib-s-malate in treating patients with~     hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth~   "
95076|NCT01812655|"~     Relief of severe burn wound care pain may require both medications to relieve pain and~     non−medication interventions,such as distraction. Little is known about distraction's~     effectiveness. Virtual reality may be an effective distraction. The aims of this study are~     1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction,~     compared to passive distraction (PD) by watching a movie, and usual care (SC) that is~     provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to~     determine the relationship among anxiety, desire for distraction, and engagement with~     distraction on the pain.~   "
95077|NCT01812642|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores~     what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self).~   "
95078|NCT01812629|"~     The study objective is to assess the growth, tolerance and efficacy of a complete amino~     acid-based medical food in children with chronic diarrhea.~   "
95079|NCT01812616|"~     An open-label phase to assess the frequency and severity of adverse events in recurrent~     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part~     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).~     Part B will be reported here.~   "
95080|NCT01812603|"~     An open-label phase to assess the frequency and severity of adverse events in recurrent~     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part~     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).~     Part A will be reported here.~   "
95081|NCT01812590|"~     Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient~     hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise~     bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.~   "
95082|NCT01812577|"~     Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and~     after the procedure. During the procedure patients need deep sedation and cannot be~     collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is~     to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can~     provide anesthesia and post-operative analgesia in these patients.~   "
95083|NCT01812564|"~     The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth~     factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring~     injuries.~      The hypothesis is that the time to return to sport is shorter in the patient group treated~     with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in~     comparison with 2 control groups:~        -  the patient group treated with Platelet Poor Plasma (PPP) injections in combination~          with exercise therapy (control injection AND usual care).~        -  the patient group treated with exercise therapy (usual care)~   "
95084|NCT01812551|"~     Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000~     individuals worldwide, including about 3,800 in Italy -- is often associated with low bone~     mineral mass. The current aggressive therapies have ensured a much longer survival of CF~     patients but this has led to a higher frequency of osteoporosis and bone fractures, a~     serious problem which not only affects quality of life, but also hinders further therapeutic~     measures.~      The aim of this study, conducted on a large group of children, adolescents and young adults~     with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment~     with RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility~     and efficacy of alendronate treatment (for another year) in patients not responding to~     calcium + 25-OH vitamin D alone.~   "
95085|NCT01812538|"~     This study is conducted to evaluate the effectiveness of DIC075V on ventricular~     repolarization in healthy subjects compared to placebo after a single dose of DIC075V~     administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the~     baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular~     repolarization in healthy subjects compared to placebo. Other secondary objectives are as~     follows:~        -  To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects~          compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD).~        -  To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between~          the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations.~        -  Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy~          subjects.~        -  Provide additional safety information.~   "
95087|NCT01812512|"~     People with heart failure (HF) are hospitalized over a million times a year in the US at a~     cost over $39 billion dollars. About half of the patients are readmitted within 30 days.~     Despite a number of institutional reforms, cost and readmissions remain high in the VA. The~     VA Home Telehealth (HT) monitoring program decreases preventable readmissions, but HF~     readmissions remain increased in the VA. Despite an active and effective HT program, the~     Charleston VAMC has the highest HF readmission rate in VISN 7. Though the HT program~     introduces communication, self-management, and shared decision-making in initial training,~     previous QUERI RRP evaluation identified lower than expected levels of specific~     communication practices associated with the promotion of HF self-management and shared~     decision-making, mediated by the requirements of the technology.~   "
95088|NCT01812499|"~     Inhospital the blood transfusion process consists of many phases: ordering the blood~     product, analysis of the blood sample, delivery, transport and storage of the blood product~     and administration. In each of these phases (near) accidents may occur. A severe transfusion~     incident refers to the transfusion of a wrong blood product, whereas a near miss is detected~     before transfusion.~      In 2010 the University Hospitals Leuven introduced a new electronic patient incident report~     system for transfusion events.~      In this study the investigators will analyze the reported blood transfusion events to detect~     the most common causes of blood transfusion events and the weakest link in the blood~     transfusion chain.~   "
95089|NCT01812486|"~     A randomized clinical trial was initiated to investigate whether a reduction of the dose to~     the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a~     reduction of acute and late side effects without compromising tumor control.~   "
95090|NCT01812473|"~     The purpose of this study is to investigate the influence of hypoalbuminemia on the protein~     binding characteristics of the antifungal drug voriconazole in ICU patients.~   "
95091|NCT01812460|"~     We want to test the hypothesis, that resistance training by the use of weigth cuffs on the~     angle can prevent loss or improve the strength of the quadriceps muscle in COPD patients~     admitted to hospital due to an exacerbation. The training is started at day one of~     admittance and the strength of the quadriceps is measured by a portable dynamometer.~   "
95092|NCT01812447|"~     EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the~     safety and long-term effectiveness of the Spiration Valve System in patients with emphysema.~      Patients appropriate for the EMPROVE study are those who are currently on medical treatment~     but still symptomatic.~      EMPROVE also accepts α-1 antitrypsin deficiency patients.~   "
95093|NCT01812434|"~     Hypothesis 1: Treatment of heart transplant recipients with sildenafil, a PDE-5 inhibitor,~     will improve small artery elasticity (SAE) when compared to placebo.~      Hypothesis 2: PDE-5 inhibition will improve endothelial function, resulting in increased~     production of nitric oxide, reduced activation of circulating endothelial cells, and~     increased endothelial progenitor cells.~   "
95094|NCT01812421|"~     Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are~     asked to participate in our pre specified hypertension health education protocol (HHEP)~     after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke~     and cardiovascular diseases.~      HHEP consists of several items such as controlling the patient's hypertension level,~     monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension~     like tobacco smoking, obesity, and motivating the patient to physical activity and to a~     healthy diet.~      Patients will receive visits by a study nurse with the aim of supervising, monitoring, and~     recording the adherence of HHEP. The patients will be classified as different adherence~     level at the end of the study according to their adherence condition.~      This study is aimed at testing the hypothesis that controlling hypertension and its risk~     factors was more effective than those do not receive HHEP in reducing the recurrence of~     stroke and cardiovascular diseases.~   "
95095|NCT01812395|"~     New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are~     such new devices which is a practical alternative to the usage of scalpel and sutures. UD's~     cause overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the~     generated heat UDs might cause nerve injury. The investigators would like to see if usage of~     UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to~     conventional thyroidectomy.~   "
95096|NCT01812382|"~     This feasibility study will allow for the determination of the in vivo recovery and time of~     dialysis to optimize a future thorough microdialysis study. This is a single session, open~     label study to evaluate the feasibility of microdialysis for Retapamulin in healthy~     subjects. Three healthy subjects will be enrolled and complete the study procedures.~     Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will~     be placed in the thigh of each subject prior to the start of the microdialysis procedure.~     After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused~     for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis~     sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and~     dialysate sample collection will continue every 30 minutes for 4 hours. The approximate~     duration of study including follow-up is 4 days.~   "
95108|NCT01812226|"~     The aim of this study is to compare the predictive validity and reliability of PEth testing~     at detecting alcohol use in post liver transplant patients. A prospective cohort study will~     be used to test the primary hypothesis. Subjects enrolled in the study will be followed for~     12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview~     will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month~     Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior~     alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and~     depression. The six and 12 months interview will focus on previous 30 day alcohol use. The~     baseline, six and 12 months interviews will be conducted face-to-face at each site. While~     many patients who receive a transplant do not live near the academic medical center that~     performed the surgery patient, they normally have a transplant clinic visit 1-2 times per~     year. Medical records and transplant databases will be assessed to assess the other~     variables of interest.~   "
95109|NCT01812213|"~     To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have~     the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to~     Alzheimer's disease (AD) from those who do not.~   "
95110|NCT01812200|"~     Background:The acute coronary syndrome (ACS) is a complication of coronary artery disease~     (CAD) and associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic~     acid (ASA) with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the~     treatment of patients with advanced CAD. Due to delayed onset of action, intersubject~     variability or resistance to clopidogrel, different platelet aggregation inhibitors have~     been developed. Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy~     compared to clopidogrel in the prevention of cardiovascular death in these patients.~      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial~     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in~     patients with AF, the direct factor Xa inhibitor rivaroxaban and the direct thrombin~     inhibitor dabigatran have recently received approval for prophylactic treatment of patients~     with non-valvular AF.~      However, there is a lack of efficacy or safety data for the combined impact of~     antithrombotic drugs in patients requiring arterial and venous thromboembolic prophylaxis~     due to their underlying co-morbidities.~      Study objectives: To evaluate the effect of ticagrelor + ASA in combination with dabigatran,~     rivaroxaban or phenprocoumon at steady state on markers of coagulation activation. The~     effects on coagulation activation will also be studied after a single dose of dabigatran,~     rivaroxaban or ticagrelor and at a therapeutic INR of phenprocoumon.~      Study design: A single-centre, prospective, randomized, controlled, analyst-blinded study in~     three parallel-groups. Subjects will receive ticagrelor + ASA in combination with dabigatran~     (treatment A), rivaroxaban (treatment B) or phenprocoumon (treatment C). All IMPs will be~     administered at doses indicated for stroke prevention in AF or ACS. Markers on thrombin~     generation and platelet activation will be studied in venous blood where coagulation is in~     resting state and in shed blood where the clotting system is activated in the~     microvasculature in vivo: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT),~     β-thromboglobulin (β-TG), D-Dimer, thromboxane B2 (TxB2), CD40 ligand (CD40L), p-Selectin.~     Further, the endogenous thrombin potential (ETP), inhibition of factor Xa activity,~     activated partial thromboplastin time (aPTT), prothrombin time (PT), Biophen® and Hemoclot®~     will be assessed in venous blood.~      Study population: A total of 60 healthy, non-smoking and drug-free male volunteers will be~     enrolled in this trial and randomized into one of three balanced groups (treatment A, B and~     C; n = 20 per group).~      Main outcome variables: β-TG, F1+2 and TAT in shed blood~      Additional outcome variables:~        -  D-Dimer, TxB2, CD40L and p-Selectin in shed blood~        -  β-TG, F1+2, TAT, D-Dimer, TxB2, CD40L, p-Selectin, ETP, aPTT, PT, inhibition of factor~          Xa, Biophen® and Hemoclot® in venous blood~      Risk/ benefit assessment:Total blood loss will be, dependent on treatment allocation,~     between 330 ml and 510 ml throughout the entire study period of 4 - 5 weeks. This amount of~     venous blood is considered to be acceptable in this healthy population. Blood sampling~     procedures may cause mild and transient pain. A minor haematoma may occur at the site of~     needle insertions. Bleeding time incisions may leave small persistent scars. Administration~     of the study drugs, in particular as triple combination for 5 days, results in transient~     hypocoagulability and may cause overt or occult bleeding. The risk is considered low in the~     healthy subjects under study. Continuous monitoring of safety parameters (haemoglobin,~     haematocrit, platelet count, coagulation) and surveillance of the overall status will be~     performed during study participation. Subjects will be instructed to avoid vigorous physical~     exercise and handling of hazardous machinery during study participation. ASA, dabigatran and~     rivaroxaban can cause gastrointestinal discomfort. Other side effects are rare.~      The combination of these novel anticoagulants (dabigatran, rivaroxaban, ticagrelor) has not~     been investigated so far. Conducting this study in a healthy population limits potential~     bleeding risk reported from drug interactions and impaired liver or renal function, which~     may influence the pharmacokinetics and -dynamics of the investigational products.~      This study can provide information on haemostatic system activation in vivo during triple~     treatment with antithrombotic drugs, which is indicated for patients with AF and ACS. The~     results of this study may provide dosing guidance for risk reduction of patients with ACS~     and AF.~   "
95097|NCT01812369|"~     Radical cystectomy remains the gold standard treatment for invasive non metastatic~     transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival~     rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in~     patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with~     lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been~     developed in order to improve these results. Thanks to randomized trials and meta-analysis,~     it can be concluded that perioperative chemotherapy increases overall survival with an~     absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined~     tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen~     to be delivered are not yet determined. Meta-analyses have shown that the benefit is only~     observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of~     gemcitabine and cisplatin are delivered since this combination has been shown to yield a~     similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate,~     vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown~     to be associated with higher response rates than MVAC in bladder metastatic disease, also a~     better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators~     therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in~     term of progression-free survival in patients for whom chemotherapy has been decided, before~     or after radical cystectomy. Secondary endpoints include overall survival, side effects,~     response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and~     cisplatin sensitivity. The total number of patients projected is 500. The number of patients~     is based on the median progression-free survival rate of 50% at 3 years observed in patients~     treated with GC (standard arm A) in the perioperative setting. An absolute improvement of~     10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An~     interim analysis is planned after the occurrence of 174 events. With an estimated uniform~     accrual rate of 140 patients per year for 3.5 years and exponential survival, the final~     analysis is expected to occur 8 years after the start of the trial.~   "
95098|NCT01812356|"~     The aim of this study is compare the surgical convenience and early and long-term outcomes~     of cryomaze procedure using nitrous oxide with using Argon gas.~      The investigators will analyze the pathologic findings of atrial tissue after cryoablation~     using two probes and early and long-term outcomes with Holter monitoring. Atrial~     fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.~   "
95099|NCT01812343|"~     Estimate the response of ankle to brachial pressure index to incremental maximum exercise in~     subjects free from prior cardiovascular disease.~      Estimate morbi-mortality of included patients over a 5 years follow up.~   "
95100|NCT01812330|"~     The purpose of this study is to compare the efficacy and safety of ticagrelor with~     clopidogrel~   "
95101|NCT01812317|"~     Fire-fighters are at increased risk of death from heart attacks when compared to other~     emergency service professionals whose jobs involve similar components such as emergency~     call-outs and shift work. The unique risk to fire-fighters is likely to reflect a~     combination of factors including extreme physical exertion, mental stress, heat and~     pollutant exposure.~      In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths~     were classified according to the duty performed during the onset of symptoms or immediately~     prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart~     attack) occurred during fire-suppression whilst this activity represented a relatively small~     amount of a fire-fighters professional time. Fire simulation training centers offer a unique~     opportunity to assess the heart, blood and blood vessel response to fire suppression in a~     controlled environment.~      In this study the investigators will assess healthy career fire-fighters on two occasions:~     following a fire-suppression training exercise in a purpose built real-fire training center,~     and following a sedentary period as a control. The investigators will take blood samples to~     measure platelet activity (platelets are the particles in blood that help blood clot) and~     will examine how blood clots outside of the body. The investigators will then perform~     studies placing small needles in the arm to assess blood vessel function following fire~     suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart~     function we hope to understand the mechanisms whereby the risk of a heart attack is~     influenced by fire suppression. The investigators hypothesize that following the~     fire-suppression exercise firefighters blood will clot more readily and their blood vessels~     will not relax properly which are two of the main processes in the development of a heart~     attack.~   "
95102|NCT01812304|"~     This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery~     on a pelvic model is significantly better in terms of a technical skills scoring system~     compared to frontal teaching.~   "
95103|NCT01812291|"~     The study examines the efficacy of a stepped care approach for depressed diabetes patients~     (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical~     depression will be randomly assigned to either a stepped care approach or a~     treatment-as-usual condition. The stepped care approach consists of three treatment steps~     comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific~     CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned~     to the stepped care approach will be treated stepwise until a clinically significant~     reduction of depressive symptoms is attained or all three treatment steps are passed.~      The primary outcome of the first study objective is a clinically significant reduction of~     depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of~     diabetes-related distress and improvement of well-being, health-related quality of life,~     diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit~     analyses will be performed.~      The second study objective is to analyse associations between diabetes, depression, and the~     serum levels of inflammatory markers.~      The third study objective is to analyse the courses of depressive conditions in diabetes~     with regard to recovery rates and incidence of major depression.~   "
95104|NCT01812278|"~     The goal of this study is to determine whether the ACT website provides higher quit rates~     than a current standard smoking cessation website.~   "
95105|NCT01812265|"~     This study will evaluate the pharmacological activity of PF-06305591 in healthy male~     volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity~     evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.~   "
95106|NCT01812252|"~     This randomized clinical trial studies different chemotherapies in treating patients with~     myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a~     donor stem cell transplant helps stop the growth of cancer cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells, and may prevent the~     myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets.~   "
95107|NCT01812239|"~     A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal~     Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.~   "
95111|NCT01812187|"~     The purpose of this study is to increase access for rural Veterans to evidence-based,~     person-centered, individually tailored treatment for alcohol use problems. The primary aim~     is to evaluate the acceptability and feasibility of using mobile technology deliver~     treatment for alcohol use disorder. A mobile application will be used replacing the usual~     setting of clinical visits that accompanies standard face-to-face CBT therapy. The~     application will be loaded onto an iPod, which will be distributed to each participant that~     has been found to be eligible to participate.~   "
95121|NCT01812057|"~     The purpose of this study is to compare post-cesarean section consumption of pain medication~     between two groups of patients undergoing scheduled cesarean section at term gestation who~     receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo~     at 24 hours after surgery. The hypothesis is that a single perioperative dose of~     dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in~     women having cesarean delivery under spinal anesthesia.~   "
95122|NCT01812044|"~     The purpose of this study is to determine if local anesthetic, either a subtenons injection~     (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel~     (applied directly on the surface of the eye) given at the end of strabismus surgery reduces~     postoperative pain. Some surgeons routinely use either the subtenon and/or topical~     anesthetic for pain at the end of strabismus surgery.~   "
95123|NCT01812031|"~     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer~     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.~     In case of cancer, metabolism is, classically, increased and some hot spots are visible on~     PET images. Because of respiratory motion some lung tumours (especially the smallest ones)~     can be falsely interpreted by the clinician.~      The investigators developed a respiratory-gated PET method in order to reduce the motion~     issue. The investigators designed a study to investigate its effect on lung cancer (primary~     or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the~     lungs.~      To that aim, patients presenting a lung nodule on a CT examination can be proposed to~     participate this study. After the standard PET acquisition (acquired in free-breathing), an~     additional 10 minutes respiratory-gated PET acquisition is performed without additional~     injection. After that, a breath-hold (~10s) CT is performed.~   "
95124|NCT01812018|"~     The purpose of this exploratory phase II study is to assess the effectiveness and safety~     profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel~     in treatment of soft tissue sarcoma patients with pulmonary metastases.~   "
95125|NCT01812005|"~     This phase II trial studies how well alisertib with and without rituximab works in treating~     patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Alisertib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cancer-killing substances to them. Giving alisertib with and without rituximab may be~     an effective treatment for B-cell non-Hodgkin lymphoma~   "
95126|NCT01811992|"~     Despite the marginal improvements in survival of patients suffering from malignant glioma~     treated with gene therapy vectors, the clinical trials conducted so far using viral vectors,~     in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe~     therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of~     malignant glioma using gene transfer modalities typically consists of surgical debulking of~     the tumor mass followed by the administration of the viral vectors into the brain tissue~     surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and~     immune-mediated stimulatory (Flt3L) gene transfer approaches delivered by first generation~     adenoviral vectors.~   "
95127|NCT01811979|"~     Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The~     purpose of this study was to determine the effectiveness of local anesthetic eye drops and a~     pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye~     examinations for retinopathy of prematurity.~   "
95128|NCT01811966|"~     Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability~     during introduction of anesthesia.~      The purpose of this study is to test the hypothesis that a defined preoperative volume~     substitution compared to standard procedure will result in a reduced incidence of~     hemodynamic instabilities during introduction of anesthesia in elective surgery patients.~   "
95129|NCT01811953|"~     Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of~     two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions~     and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets~     empagliflozin and metformin under fed conditions (Part II).~   "
95130|NCT01811940|"~     The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of~     the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine~     dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial.~     The proportion of participants achieving sustained cocaine abstinence for three consecutive~     weeks at the end of the study will be significantly greater for the combined~     pharmacotherapies group compared to the placebo group.~   "
95131|NCT01811927|"~     The purpose of this study is to the assess the clinical performance of the BIOTRONIK~     PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary~     arteries.~   "
95132|NCT01811914|"~     Focused transthoracic echocardiography (TTE) is a technique, which allows quick and~     non-invasive diagnosis and monitoring in hemodynamic instable patients. There are~     preliminary data supporting the hypothesis that TTE is feasible in the operating theatre.~      The purpose of this study is to test the hypothesis that intraoperative focused TTE has an~     impact on high risk patients´ management when it is added to standard extended monitoring~     practices in hemodynamic instabilities.~   "
95133|NCT01811901|"~     In patients with acute ischemic stroke: the sooner the thrombolysis treatment is~     administered after symptom onset - the better the outcome. This delay can be dissected into~     onset-to-door time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in~     participating centres.~   "
95134|NCT01811888|"~     This is a prospective, observational study, aimed to establish the relationship between an~     inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the~     probability to develop chronic pain after surgery (persistent post surgical pain).~     Endogenous analgesia efficiency will be measured during the month previous to surgery using~     quantitative sensory testing (QST). Persistent post surgical pain will be defined as~     presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated~     knee, 6 months after surgery.~   "
95954|NCT01801150|"~     Aim: To assess if six months of treatment with CPAP associated with conventional drug~     therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep~     apnea-hypopnea syndrome SAHS)~   "
95136|NCT01811862|"~     This is a prospective randomized controlled trial to obtain preliminary data for the design~     of a future definitive efficacy study. A randomized controlled trial is needed because~     comparison to historical data would be biased. The investigators will use sham acupuncture~     as the control to account for effect from attention from and interaction with the therapist.~   "
95137|NCT01811849|"~     A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to~     Humalog® in Subjects with Type 1 Diabetes~   "
95138|NCT01811836|"~     Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc~     homeostasis and environmental enteropathy (EE).~      Specific -~        1. To measure zinc status using a dual zinc stable isotope assay before and after~          administering resistant starch (RS) in 20 children.~        2. To measure intestinal function using a site-specific sugar absorption test before and~          after administering RS in 20 children.~        3. To determine the relationship between RS and zinc homeostasis.~        4. To determine the relationship between RS and environmental enteropathy.~   "
95139|NCT01811823|"~     Prospective, open-labelled study which will enrol 360 participants in four groups of 80~     participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults~     without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed~     TB, HIV-infected adults with concurrent microbiologic confirmed TB.~      Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza~     Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.~      Objective:~      • To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on~     immune responses~   "
95140|NCT01811810|"~     The most common treatment for men with high risk prostate cancer is radiation therapy (XRT)~     followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with~     substantial metabolic, physical, mental and sexual side-effects. In this study, the~     investigators propose a treatment strategy to optimize the control of high risk prostate~     cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent~     with docetaxel and adjuvant short-course AD. The investigators hypothesize that this~     approach will be superior to the current standard of care and obviate the need for long term~     AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and~     chemotherapy and short term ADT.~   "
95141|NCT01811797|"~     This is a prospective, randomized, double-blind clinical study comparing safety and efficacy~     of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy~     (LI-ESWT) device - Renova on symptomatic ED patients to the safety and efficacy of the~     control sham patients.~   "
95142|NCT01811784|"~     Several human Nipah virus (NiV) outbreaks have occurred in Bangladesh since 2001with 71%~     case fatality. Outbreak investigations have repeatedly identified drinking fresh date palm~     sap as a risk factor for NiV transmission. Bats are the reservoir of NiV and infected bats~     can shed virus through both saliva and urine and can contaminate the raw sap. The virus can~     transmit to humans through ingestion of contaminated sap. To interrupt bats access to the~     sap, sap harvesters (gachhis) occasionally use skirts make by local materials. These skirts~     have been found to be effective to interrupt bats' access to the sap. As an indirect effect~     of the community level skirt promotion, some people stopped drinking raw sap. When trees~     have skirts, bats cannot access the sap and when people do not drink sap, they are at much~     lower risk of contracting Nipah virus. The purpose of this study is to design, implement and~     evaluate behavior change interventions to prevent human consumption of NiV contaminated sap~     through reducing raw sap consumption from unprotected trees in a district of the NiV~     affected regions in Bangladesh.~   "
95143|NCT01811771|"~     Background:~      Vibrio cholerae is one of the major causes of severe diarrheal disease in Bangladesh. It is~     estimated that there are about 450,000 cholera cases each year in Bangladesh. Cholera is~     prevalent in both urban and rural settings in the country. Policy decisions about how best a~     new public health tool can be incorporated into the system requires evidence. Investigators~     have recently carried out a feasibility study of oral cholera vaccine in urban Dhaka in~     Mirpur (Protocol #10061). However, whether a similar system can also be utilized in a rural~     area in Bangladesh needs to be studied.~      The hospital disease surveillance data from International Centre for Diarrhoeal Disease~     Research, Bangladesh (icddr,b) reveals a substantial burden of cholera from Keraniganj~     upazila. Investigators propose a feasibility study of oral cholera vaccination by using the~     existing national immunization service delivery mechanism in Keraniganj. This study will~     help to provide evidence for the policy makers in introducing oral cholera vaccine in~     preventing cholera in high risk rural areas in Bangladesh.~      Hypothesis:~      That icddr,b in collaboration with the Government of Bangladesh will be able to implement an~     oral cholera vaccine program that;~        1. reaches residents of rural union of Keraniganj~        2. reduces the incidence of diarrhea due to Vibrio cholerae~      Objectives:~        1. Carry out cholera vaccination in one rural union in Keraniganj.~        2. Evaluate the impact of vaccination in reducing cholera in the study area~      Methods:~      Two unions in Keraniganj will be selected; around 30,000 individuals in one union will be~     vaccinated and impact evaluated by comparison with another similar union. After vaccination,~     passive cholera surveillance at the Upazila hospital will be conducted for two years on the~     patients from the two unions.~      Outcome measures/variables:~      Cholera vaccination programme will be assessed by the number of doses administered, drop-out~     rates between the two rounds, the proportion of vaccine wastage, and the vaccine coverage.~      Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the~     vaccinated and non vaccinated union will be calculated and compared to assess the impact of~     intervention.~   "
95144|NCT01811758|"~     The investigators expect that a culturally specific group intervention targeting African~     American smokers will result in greater smoking cessation rates compared to a standard~     intervention.~   "
95145|NCT01811745|"~     The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying~     music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared~     to multicomponent exercise training.~      This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm,~     parallel group, randomized controlled trial in which 140 community-dwelling older adults at~     high risk of falls are randomly assigned to receive either a music-based multitask training~     intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training~     intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed~     at three time points: baseline (before intervention initiation), 6-month (intervention~     mid-point), and 12-month (intervention termination). Outcomes of interest include physical~     and cognitive performances, and falls. In addition, the investigators specifically address~     brain circuits in an exploratory sub-study. Volunteer trial participants from both study~     arms are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and~     12-month.~   "
95146|NCT01811732|"~     The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus~     Aztreonam in the treatment of patients with complicated bacterial and soft tissue~     infections.~   "
95147|NCT01811719|"~     An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This~     randomized trial of an intervention to assess and prevent intimate partner violence during~     pregnancy and the post-partum builds upon the David Olds model of nurse home visitation~     (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be~     effective in multiple settings in preventing child abuse and enhancing maternal and child~     health and psychosocial outcomes. However, prior research has shown that the NFP~     intervention is not as effective in homes where there is intimate partner violence (IPV).~     Although the NFP by itself has reduced IPV in one setting, it has not in another. The~     proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced~     Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The~     ECI is based on a choice or empowerment model whereby women can choose among interventions~     related to her goal for her current intimate relationship. If IPV or emotional abuse or~     controlling behaviors are assessed, the intervention is based on two interventions shown to~     be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention~     and the McFarlane and Parker brochure driven intervention). For women desiring to enhance~     marital quality, the Markman and Stanley PREP model that has been shown to enhance~     relationship quality will be offered. The PREP model also has some preliminary evidence of~     preventing IPV. For women with other risk factors for IPV in their own or their partners'~     history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource~     linkage (beyond referral) strategies as with the NFP model will be used to obtain community~     resources to address these risk factors. 250 women referred to the Multnomah County Health~     Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP)~     and visited according to the regular NFP schedule during pregnancy and until the infant is~     24 months old. The intervention will concentrate on the prenatal and immediate (first 6~     months) post partum period with regular IPV, emotional abuse and controlling behavior~     assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI,~     depression - Edinborough, & parenting stress), will occur at 3 months before delivery, 9~     months & 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.~   "
95148|NCT01811706|"~     Investigators expect there will be improvement in walking speed and steadiness after taking~     Dalfampridine, thereby improving activities of daily living and enhancing social and~     occupational functions for patients with spinocerebellar ataxia.~   "
95149|NCT01811693|"~     This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin)~     administered by paramedics in the field within 2 hours of symptom onset to 45 severely~     hypertensive stroke patients. The primary objective of the study is to evaluate the~     feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in~     achieving modest reduction of blood pressure. Patients with acute stroke will be identified~     in the field by paramedics who have received training in basic and advanced cardiac life~     support, stroke recognition, and specific procedures relevant to the proposed study.~     Physician-investigators will obtain informed consent for each subject for study entry after~     cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment~     by applying transdermal GTN patch in the first two dose-tiers, and administering a single~     sublingual GTN metered spray followed by application of the transdermal system in the last~     dose tier. The sites involved in the study will be emergency medical services rescue~     ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.~   "
95150|NCT01811680|"~     To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill~     device devised by local engineers for subacute hemiplegic stroke patients for gait~     rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10~     chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2~     months.~      Research protocol and standardized outcomes measures will be used.~   "
95151|NCT01811667|"~     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of~     rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular~     organisations.~      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.~   "
95152|NCT01811654|"~     The purpose of this study is to determine the safety and effectiveness of intra-articular~     hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome~     (PFPS) and determine if this treatment can provide incremental clinical benefits over~     standard care for patients with this diagnosis.~   "
95153|NCT01811641|"~     Accumulating evidence suggests that early-life nutrition can affect metabolism and thus~     increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible~     mechanism to explain these effects is epigenetic variation at critical periods of~     development. Epigenetic variation describes non-inherited permanent alterations to an~     individuals DNA.~      Recent work in mouse models has demonstrated that maternal nutritional status can affect~     such epigenetic processes such as DNA methylation and gene expression during embryonic~     development, with profound effects on outcomes. The investigators aim to study these~     processes in humans for the first time. The investigators will exploit the experiment of~     nature setting in The Gambia, i.e. fluctuation in diet according to season. During the~     'hungry' season diets are known to be depleted in nutrients required for epigenetic gene~     regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured~     in pregnant women according to season. A blood sample will also be taken from babies born to~     these women to determine whether there is a direct effect of diet on mothers' nutritional~     status and hence variation in DNA methylation patterns in their babies by season.~   "
95154|NCT01811628|"~     The goal of this research study is to collect information from Latino and Hispanic smokers~     and recent quitters about factors that are important to them when they are trying to quit.~     Researchers want to better understand some of the challenges and problems that Latinos and~     Hispanics face when they try to quit smoking, and then use that information to design a~     treatment for future smokers.~   "
95155|NCT01811615|"~     Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in~     reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing~     alone.~      Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study.~     After screening and stratification by sex and papillary bleeding index (PBI), participants~     were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX +~     0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control);~     (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3)~     toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental~     rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index~     (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were~     advised to brush their teeth as usual during the eight weeks study period. Additionally,~     groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr.~     Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks~     after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for~     statistical analysis.~   "
95156|NCT01811602|"~     A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training~     intervention led by a physiotherapist on urinary incontinence, quality of life and sexual~     health in women who report urinary urgency and incontinence following surgery and radiation~     treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).~   "
95157|NCT01811589|"~     Failure of ventricular catheters remains a significant problem in patients with~     hydrocephalus. The purpose of this study is to determine whether the use of a simple~     instrument assisted by a smart phone application software can achieve a more precise~     placement of ventricular catheters than the standard free-hand placement technique.~   "
95158|NCT01811576|"~     The primary objective of this study is to evaluate the clinical effect of TV-1106.~   "
95159|NCT01811563|"~     The purpose of this study is to assess the differences in functional and patient reported~     outcomes between total knee replacement (TKA) implants. In addition, this work will examine~     the correlation between functional assessments and patient reported outcomes following~     surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and~     then one year following TKA. Subjects will complete a series of patient reported outcomes as~     well as a series of functional outcomes at each of the time points of interest. The analysis~     will include a repeated measures design to determine differences between groups across time~     as well as correlations between the functional and patient reported outcomes. This work will~     hopefully determine the importance of using objective functional outcomes following TKA as~     well as determining the need for patient assessments out to one year following surgery.~   "
95160|NCT01811550|"~     The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT):~     Response to Insulin Administration and Blood Glucose Control proposal is designed to~     accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase~     III multicenter, randomized, controlled trial planning to determine the efficacy and~     validate the safety of glycemic control in stroke patients. The SHINE trial will recruit~     1,400 AIS patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3~     days of hyperglycemia control with intravenous (IV) insulin therapy or control therapy with~     subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood~     coagulation marker levels will be measured before and at 48 hours after the start of~     treatment. Baseline and temporal changes in biomarkers levels will be compared between~     treatment groups.~      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in~     patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as~     the standard fashion.~      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in~     patients with than without favorable (SHINE) outcome (defined as the baseline stroke~     severity adjusted measure of functional ability at 90 days after AIS).~      Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation~     levels and functional outcome in T2DM patients after stroke. Patients treated with IV~     Insulin for hyperglycemia control with favorable (SHINE) outcome will have greater decreases~     in blood coagulation levels than either IV Insulin-treated patients without favorable~     outcome or SQ Insulin-treated with or without favorable outcomes at 90 days after AIS.~   "
95161|NCT01811537|"~     Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious~     complications. Mitral valve (MV) repair offers several important advantages compared with~     valve replacement and it achieves excellent midterm and long-term results. Two major~     problems of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop~     technique) are deciding the length of the neochordae and tying the knot at the intended~     length. Therefore, a great need still exists to find new method to simplify and precise the~     length of neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair~     using neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will~     be done preoperatively for all patients. Two, three, and four chamber view of each patient~     will be pre-operatively recorded. The device will be set with extracted measurements.~     Artificial corda loops are made using CV-4 ePTFE sutures. After artificial chordae~     replacement, the ring annuloplasty will be done. Follow up: A leakage test after attaching~     the 1st loop; Post operative trans esophageal echocardiography (TEE) and determining the~     severity of mitral regurgitation [Wall motion Score Index (WMSI), Mitral Annulus Area (MAA),~     LVEF, End Systolic Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time~     (IVRT), (IVRT/(QE-QE^') ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E^' ),~     HR]; TEE 3 months after discharge; Cross clamp time; Intubation period in ICU.~   "
95162|NCT01811524|"~     The main goal of the study is to present a framework, which integrates DNA, RNA and tissue~     data to identify and prioritize genetic events that represent clinically relevant new~     therapeutic targets and prognostic biomarkers for different kinds of brain tumors. The~     investigators study the regulation of neoplastic cell growth by oncogenes, tumor-suppressor~     and other cancer related genes using modern molecular genetic methods, such as~     chromogenic-in-situ hybridization, comparative genomic hybridization (CGH), array-CGH, cDNA~     microarray etc. In these studies the investigators utilize disease-specific tissue~     microarrays (TMA) which the investigators have constructed since 1999. Until now up to 3000~     different brain tumours have been sampled to our TMA:s. These permit high-volume~     simultaneous analysis of molecular targets at the DNA, mRNA and protein levels. Research~     group has also focused its interest on the neoplastic development of gliomas, particularly~     on their hereditary and environmental factors.~   "
95163|NCT01811511|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled~     crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of~     metabolic syndrome. The investigators measured decrement of body fat parameters, including~     Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and~     monitored their blood pressure.~   "
95199|NCT01811043|"~     The goal of this study is to examine whether a guided meditation intervention will reduce~     anxiety and distress as compared to a music intervention or radiologist supportive dialogue~     in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation~     and music interventions are administered through use of headphones during routine outpatient~     imaging-guided core needle breast biopsies. Women in the guided meditation and music~     conditions will be given a CD with instructions for home practice. Women complete follow-up~     questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is~     examined for 60 months.~   "
95164|NCT01811498|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority~     of all primary brain tumors in adults. This group of tumors also exhibits the most~     aggressive behavior, resulting in median overall survival of only 9-12 months. Initial~     therapy consists of either surgical resection, external beam radiation, or both. All~     patients experience a recurrence after first-line therapy, so improvements in both~     first-line and salvage therapy are critical to enhancing quality-of-life and prolonging~     survival. It is unknown if currently used intravenous (IV) therapies even cross the blood~     brain barrier (BBB). We have shown in a previous phase I trial that a single Superselective~     Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective~     in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an~     extension of that trial in that we seek to test the hypothesis that repeated dosing of~     intra-arterial Bevacizumab is safe and effective in the treatment of newly diagnosed~     malignant glioma. By achieving the aims of this study we will also determine if repeated~     intra-arterial Bevacizumab improves progression free and overall survival in newly diagnosed~     patients. We expect that this project will provide important information regarding the~     utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way~     these drugs are delivered to our patients in the near future.~   "
95165|NCT01811485|"~     The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and~     50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin~     monotherapy. This study was conducted to support registration of the fixed-dose combination~     of vildagliptin and metformin for the treatment of T2DM in Japan.~   "
95166|NCT01811472|"~     The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as~     assessed by MRI and to assess its safety and tolerability profile in subjects with~     non-alcoholic fatty liver disease (NAFLD).~   "
95167|NCT01811459|"~     Background:~      Delirium is an important problem in critical care. Its prevalence often reaches 75% in~     intensive care patients. Its occurrence is associated with numerous complications and~     deleterious consequences such as death, longer stay, higher cost, and long-term cognitive~     impairment. Delirium treatment entails correcting its underlying causes and usually~     initiating a pharmacological intervention with an antipsychotic. Typical antipsychotics,~     particularly haloperidol, are commonly used to treat delirium although few~     placebo-controlled trials of pharmacological treatments for delirium have been conducted.~     Furthermore, appropriate doses for delirium treatment have yet to be established. In~     critical care, two pilot studies provided the first randomized, placebo-controlled evidence~     for the pharmacologic treatment of ICU delirium. One found that neither haloperidol nor~     ziprasidone significantly reduced the incidence or duration of delirium compared with~     placebo whereas the other one found that quetiapine added to as-needed haloperidol resulted~     in faster delirium resolution.~      Objective:~      The goal of this study is to determine the effectiveness of antipsychotics in regular dosage~     regimen (quetiapine group and haloperidol group) compared to as-needed haloperidol (placebo~     group) in the pharmacological treatment of delirium. We will conduct a three-arm randomized~     controlled trial to achieve this goal.~      Materials and Methods:~      During one year, 45 delirious patients from three intensive care units will be recruited and~     randomized into one of three groups. Randomization will be performed in blocks of 9 by the~     pharmacy department, using a random numbers table.~      Patients will be continuously screened for delirium using the Intensive Care Delirium~     Screening Checklist (ICDSC) as part of routine care. A positive screening score (≥4) will~     warrant confirmation of delirium diagnosis by the treating physician. Treatment will begin~     according to randomization group, provided that informed consent has been obtained. Delirium~     status will be monitored during the episode using the Nursing Delirium Screening Scale~     (Nu-DESC). When the Nu-DESC monitoring will become negative for delirium (total score below~     2), the resolution of the episode will be confirmed by the treating physician. A clinical~     evaluation by a psychiatrist will be performed within 24-48 hours of each of the two~     evaluations made by the treating physician (beginning and end of the delirium episode).~      The treating physician will initiate twice-daily treatment at the first of five levels for~     each of the three groups: 1) 1 mg of intravenous (IV) haloperidol + oral (PO) placebo, 2) 50~     mg of PO quetiapine + IV placebo, or 3) IV + PO placebo. Therapy will be titrated upwards on~     a daily basis by increments of 1) 1 mg of IV haloperidol or 2) 50 mg of PO quetiapine, or 3)~     IV + PO placebo every 12 hrs, respectively, if the subject received at least two doses of~     as-needed haloperidol in the previous 24 hrs. As-needed (PRN) doses of 2 mg of IV~     haloperidol q 30 minutes will be available to patients from all three groups and~     administered by nurses until symptoms associated with delirium resolve. In case of~     unsuccessful as-needed treatment, rescue (STAT) doses of 5 mg of IV haloperidol q 30 minutes~     will be available to patients from all three groups and will be administered by nurses if~     agreement is reached with the treating physician that the situation indeed calls for it. The~     treatment level of patients requiring a STAT dose will immediately be raised to the above~     level. The treatment will stop when one of the following occurs: (1) the subject is deemed~     by the treating physicians, based on their clinical judgment, to no longer demonstrate signs~     of delirium and, therefore, to no longer require scheduled therapy with an antipsychotic~     agent; (2) 21 days of therapy has elapsed; (3) ICU discharge occurred; or (4) a~     life-threatening adverse event potentially attributable to the study drug occurred that~     warranted discontinuation of the study drug.~      Adverse effects will be closely monitored: extrapyramidal reactions, neuroleptic malignant~     syndrome, drowsiness, hypotension, QTc prolongation. The treatment level of patients~     presenting a non life-threatening adverse event will immediately be lowered to the level~     directly below.~      The sample size was calculated for a 2-tailed test with an alpha of .05 and a power of .80.~      The primary statistical analysis will involve Cox proportional time to event analysis~     comparing the three groups. Secondary analysis will use T-test comparisons for continuous~     variables and chi square for proportional analysis.~   "
95168|NCT01811446|"~     The purpose of this study is to determine whether muscle activation can be accomplished more~     effectively and comfortably in challenging subjects using novel configurations of an~     activation device. A novel device will be compared side by side with a market leading~     device.~   "
95169|NCT01811433|"~     The purpose of this study is to determine whether the Halo Index has utility in detecting~     the difference between normal and non-normal recovery of patients in the first few hours~     immediately following major inpatient surgery. A small but significant percentage of~     patients who undergo major surgery will experience a major life-threatening complication in~     the first 30 days following surgery.~      The chance of developing one or more of these complications increases with the size of the~     surgery and with the severity of the patient's preexisting medical problems. It is unknown~     whether fluctuations in a patient's vital signs and other measures of bodily function that~     occur early in the recovery period are associated with postoperative complications. If this~     is so, it may be possible to predict who is at increased risk for complications based on~     monitoring during the early recovery period.~      This study will make use of the Halo Index, a compilation of measures of patient functions~     collected by non-invasive monitoring devices. In addition to heart rate, blood pressure,~     temperature, and breathing rate, these include measures of dissolved oxygen in the blood,~     the amount of hemoglobin in the blood, and other parameters.~      Patients will have two additional non-invasive monitors attached during their stay in the~     hospital post-anesthesia care unit (PACU). After the patient has been discharged from the~     hospital, their medical record will be reviewed at two time points: The first will be soon~     after discharge. Normal recovery patients will be defined as those who require only IV~     fluids, pain medications and anti-emetic medications. Non-normal recovery will include those~     who require transfusions of blood products, airway interventions such as a breathing tube,~     blood pressure medications, or heart rhythm medications. The second chart review will occur~     30 days after surgery. In this review, the presence or absence of the following events will~     be ascertained: rapid response team calls, admission to the intensive care unit, infection,~     pneumonia, the need for transfusion of 5 or more units of blood within a three-day period,~     septic shock, the need for ventilation with a breathing tube, blood clot in the lung, kidney~     failure, coma, stroke, heart attack, and death.~   "
95170|NCT01811420|"~     To evaluate the efficacy of a papain-based gel in caries removal.~   "
95171|NCT01811407|"~     Physical activity is known to help reduce obesity and the problems that accompany it.~     Walking has many benefits that make it an excellent way for obese people to increase their~     physical activity. It is hard, however, for people to stick with walking programs. Setting~     specific and challenging walking targets that are combined with timely feedback about~     discrepancies between desired and actual performance lead to higher performance. There is~     conflicting theory and evidence about the effects of publicly announcing those targets on~     commitment to the targets and on performance.~      Our research question is whether public announcements reduce the challenge level of~     commitments people set, and whether the reputational consequence of public announcements is~     severe enough to increase performance. The investigators propose a controlled trial that~     will integrate Facebook with the objective monitoring of walking via the use of pedometers~     to test the effect of public announcements on commitments and step counts.~      All participants will wear a pedometer and upload via the internet for 14 to 15 weeks,~     depending on their date of randomization. The first 2 to 3 weeks the investigators will~     determine the participant's baseline step counts. The following 12 weeks, the investigators~     will recommend a daily step count target based on the median number of steps the~     participants walked the previous week. Each week, participants will set a commitment by~     stating the number of days in the following week that he/she will meet the computer-set step~     count target.~      Commitments will be entered into an interface that will link with Facebook. Participants~     will select who of their Facebook friends will receive their commitments and/or results via~     Facebook posts. The interface will distribute those posts in a way that fits in with~     existing online social practices.~      There will be 3 experimental conditions. 1.) No public announcements 2.) Public announcement~     of commitment and 3.) Public announcement of commitment and results. In addition, groups 2~     and 3 will provide us with emails of 3 friends or family members who will act as the~     participant's support team. The investigators will send announcements directly to support~     team members.~      The investigators plan to recruit 165 participants primarily by obtaining lists of~     potentially eligible University of Michigan Health System patients from the clinical data~     repository, and sending targeted letters to these patients. Because this research - and the~     physical activity programs it will inform - aims to reach a large number of people~     efficiently, enrollment will take place online with a click-through consent document. The~     investigators have extensive experience with delivering online walking programs in similar~     populations.~      The investigators hope to learn best practices for using public announcements and online~     social networks to encourage people to exercise more or to otherwise promote wellness.~   "
95172|NCT01811394|"~     The purpose of this study is to evaluate the safety and feasibility of primary~     hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using~     the raster scan technique.~   "
95173|NCT01811381|"~     Physical exercise has proven to improve memory including in the elderly. Drugs developed to~     stop the underlying disease processes that cause Alzheimer's disease may succeed only with~     multimodal efforts to stimulate brain function. One purpose of the study is to test the~     clinical benefits of curcumin, a safe and effective compound isolated from the turmeric root~     (a component of Indian curry spices), which has been found to inhibit several potential~     disease pathways in Alzheimer's disease. Another purpose of this study is to determine how~     the addition of a physical exercise program in individuals with early memory problems may~     affect memory function or brain imaging and blood-based markers associated with Alzheimer's~     disease.~   "
95200|NCT01811030|"~     Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.~   "
95201|NCT01811017|"~     Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite~     laser for the removal of unwanted tattoos using photographic evaluation and histological~     findings.~   "
95202|NCT01811004|"~     The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis~     vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary~     Hyperhidrosis.~   "
95174|NCT01811368|"~     This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem~     cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma.~     Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps~     stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled~     monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry~     cancer-killing substances to them without harming normal cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving rituximab,~     antithymocyte globulin, and TLI before the transplant together with cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening. Giving a~     radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be~     an effective treatment for non-Hodgkin lymphoma.~   "
95175|NCT01811355|"~     The purpose of this study is to determine if mexiletine is effective for the treatment of~     muscle cramps in Amyotrophic Lateral Sclerosis (ALS).~   "
95176|NCT01811342|"~     Evaluate potential sources of error that affect the accuracy of continuous hemoglobin~     monitoring.~   "
95177|NCT01811329|"~     Phase 1 of this study involves determining how consumption of dairy fat fractions rich in~     milk fat globule membrane influences postprandial inflammation in participants with~     metabolic syndrome or obesity during a high dietary fat challenge in a six-hour period.~   "
95178|NCT01811316|"~     The purpose of this study is to evaluate the long-term efficacy and safety of lozenges~     containing probiotics in reducing gingivitis. The primary purpose of this study is to~     support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.~   "
95179|NCT01811303|"~     The purpose of this study is to determine whether D-fagomine affects glycaemic responses to~     sucrose (commercial white sugar)and quantify the response~   "
95180|NCT01811290|"~     The purpose of this study is to assess whether Multiple Sclerosis patients treated with~     Gilenya show a beneficial change over time in bone mass density and bone turnover markers as~     compared to matched controls treated with alternative FDA approved therapy or no therapy.~   "
95181|NCT01811277|"~     This is an exploratory, single-armed, open label study on the efficacy and safety of~     sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary~     system or periampullary cancer or pancreatic cancer patients. The primary endpoint is~     Objective response rate and secondary endpoint is progression free survival , overall~     survival ,1 year survival rate and safety.~   "
95182|NCT01811264|"~     Through a patient participation aid (PPA) the investigators hope to improve the psychosocial~     well-being of women diagnosed with metastatic breast cancer by empowering them to be active~     participants in clinical encounters.~   "
95183|NCT01811251|"~     The aim of the study is to show a decrease in postoperative pain during the first~     postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a~     single dose of dexamethasone, pregabalin, or a combination of these two products.~      Pain assessed by simple numerical scale will be also evaluated during the 48 first~     post-operative hours.~      Determining an optimal co-analgesic protocol through the results of this study could help~     develop validation studies with larger scale such as a medico-economic component. In~     addition, these study protocols are easy to apply (ponctual administration) and inexpensive.~   "
95184|NCT01811238|"~     Study Objectives:~        1. Primary objective~           - To assess the pain reduction after 8 weeks treatment from baseline (week 0)~        2. Secondary objectives~             -  To assess the pain reduction after 4 weeks treatment from baseline (week 0)~             -  To assess the EQ-5D~             -  To assess physician's overall satisfaction~             -  To assess subject's overall satisfaction~             -  To assess safety~   "
95185|NCT01811225|"~     Using two clinical models - pregnancy (Sample 1) and oral contraceptives (OC; Sample 2) - we~     aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone~     (Allo) and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology~     during ad libitum smoking, and (2) determine the association between Prog, Allo, and E2/P~     with the changes in smoking-related symptomatology and response to nicotine following~     overnight abstinence~   "
95186|NCT01811212|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth~     of thyroid cancer by blocking some of the enzymes needed for cell growth.~     Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to~     the tumor.~   "
95187|NCT01811199|"~     Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy~     patients.~   "
95188|NCT01811186|"~     Objectives:~        1. Objective of main interest~           - To assess the drop-out rate caused by adverse event* after 6 weeks treatment~        2. Further objectives~             -  To assess the drop-out rate caused by adverse event* after 1 week treatment~             -  To assess the pain reduction rate after 6 weeks treatment from baseline~             -  To assess the Euroquol (EQ-5D) quality of life~             -  To assess physician's overall satisfaction~             -  To assess subject's overall satisfaction~             -  To assess safety~   "
95189|NCT01811173|"~     This study is intended to examine whether directed care of a nurse working jointly with the~     patient's primary care physician, including a comprehensive assessment, creation of a~     tailored care plan, proactive follow-up, self management support and caregiver support and~     care coordination, can reduce hospital admissions for patients with multiple chronic~     conditions.~   "
95203|NCT01810991|"~     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm~     wavelength laser for the treatment of primary hyperhidrosis of the axilla.~   "
95204|NCT01810978|"~     Infants with congenital heart disease have more frequent infections and exposures to~     antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce~     the rate of sepsis and necrotizing enterocolitis in infants with CHD~   "
95955|NCT01801137|"~     A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients~     with transitional cell carcinoma of the urothelium which failed or progressed after two~     lines of chemotherapy~   "
95190|NCT01811160|"~     Schizophrenia and bipolar disorder are frequently associated with an elevated risk for~     obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic~     disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute~     and long term treatment of these disorders and are considered a first option on most~     treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight~     gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and~     mortality as well as non- adherence to treatment. There are several hypotheses attempting to~     explain the complex pathways that lead to antipsychotic therapeutic effects and their~     accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a~     large extent the body weight increase, which indicates a possible role for biological~     rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the~     pineal gland that follows a circadian rhythm with an increased secretion in the middle of~     the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in~     the brain and periphery. Thus melatonin is involved in a series of biological functions such~     as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and~     more recently in the regulation of metabolic processes including insulin, leptin, and lipid~     regulation.~      Given previous results in experimental animals, the purpose of the present study is to test~     the potential effect of melatonin in reducing or preventing some of the metabolic~     disturbances associated with SGA~   "
95191|NCT01811147|"~     The purpose of the study is to find out what parts of the brain have increased or decreased~     activity and connectivity in individuals who have bipolar disorder, major depression, or no~     history of mood disorder. Another purpose of this study is to use MRI images to determine~     which young adults with major depression may be at greater risk for developing mild or more~     severe symptoms of mania which suggests a diagnosis of bipolar disorder.~   "
95192|NCT01811134|"~     Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular~     occlusion using detachable coils, with or without expendable stent assistance. A new~     endovascular technique has recently been developed, using flow diverter stents without~     associated coils. Clinical results already published are encouraging but have to be~     confirmed. Furthermore, these medical devices are expensive in comparison to the coiling~     strategy. The purpose of this study is to compare the clinical efficacy, safety, and~     cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted~     saccular intracranial aneurysms.~   "
95193|NCT01811121|"~     Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases~     per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is~     based mainly on surgical excision as complete as possible followed by an additional~     radiochemotherapy. The prognosis depends mainly on the quality of resection when it is~     macroscopically complete. Different techniques to support the surgical resection have been~     developed over the past 20 years. The reference technique is currently the intraoperative~     neuronavigation for guiding excision by matching the intraoperative tumor boundaries with~     those of the preoperative MRI. Its main drawback is the loss of precision during the~     resection related to changes in anatomical limits of the tumor.~      The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique~     to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by~     the patient before surgery is captured specifically by the tumor cells and transformed into~     a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of~     lenses included in the microscope. Resection is thus guided by this fluorescence whose~     disappearance translates complete tumor resection.~      Its interest is twofold:~        -  Increase the percentage of complete tumor resection.~        -  Improve disease-free survival and overall survival. The objective of the study is to~          compare the FGS to the intraoperative neuronavigation for the resection of~          glioblastoma, on a medical and economical level through a randomized, prospective,~          multicenter trial.~      The annual number of patients likely to benefit of this technique in France is estimated at~     2200 new cases.~   "
95194|NCT01811108|"~     Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to~     31/12/2013,) the safety and tolerability profile (number of participants with adverse~     events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first~     line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation.~     All treatment schedules that are going to be assessed are considered by the international~     guidelines as standard therapy for patients with metastatic Colorectal Cancer.~   "
95195|NCT01811095|"~     The aim of this study is to determine if training with a robotic simulator improves ability~     to perform robotic suturing. We aim to recruit 38 participants (attending surgeons or~     residents in obstetrics and gynecology, urology, general surgery, or cardiac surgery).~     Participants will be randomized to training with a virtual reality robotic simulator in~     addition to clinical work or to usual clinical work alone for a period of 5 weeks. They will~     be tested at baseline and post-intervention in the task of suturing a inanimate model with~     the actual surgical robot. After the initial study period, the control group will have the~     opportunity to cross over and complete the training and then re-testing.~   "
95196|NCT01811082|"~     The purpose of this study is to compare the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, Pantethine Capsule,~     in Chinese patients with moderate dyslipidemia.~   "
95197|NCT01811069|"~     Upper airway obstruction (UAO) during induction of general anesthesia is a frequently~     occurring complication. The mechanism of UAO during anesthesia shares many similarities with~     the upper airway obstruction observed during obstructive sleep apnea (OSA). Obesity is major~     risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia.~     The change of body position improved upper airway stability during sleep in patients with~     OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency~     in obese patients during general anesthesia.~   "
95198|NCT01811056|"~     This study will test ways to give women more options and flexibility when they are ending~     their unwanted pregnancies. The investigators will look at uptake and acceptability of using~     mifepristone outside of the clinic for pregnancy termination.~   "
95280|NCT01809977|"~     The purpose of this study is to determine which surgical method makes less corneal haze~   "
95281|NCT01809964|"~     The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral~     Canthal Lines.~   "
95205|NCT01810965|"~     Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic~     predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about~     3/1000 white subjects (5/1000 in Brittany, France).~      For the half of these predisposed subjects, the phenotypic expression of the disease needs a~     treatment. This treatment is based upon repeated bloodletting which is generally considered~     as simple, safe and effective.~      Nevertheless, it is still questioned as regard its physiopathological justification and its~     clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound~     iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse~     physiopathological effect could have clinical consequences and could be linked with~     articular consequences which can be aggravated by the treatment.~   "
95206|NCT01810952|"~     The investigators hypothesize that includes patient weight and glucocorticoid dose can be~     used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be~     treated with pharmacological doses of glucocorticoids.~   "
95207|NCT01810939|"~     The purpose of this study was to evaluate the efficacy and safety of patiromer~     (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study~     also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic~     treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer~     treatment was also evaluated.~   "
95208|NCT01810926|"~     • The primary aim of the present trial is to assess in a randomized fashion the benefit on~     standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ®~     in transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants~     from matched unrelated donors (MUD). Both safety and efficacy of the treatment will be~     assessed, in particular in respect to the clinical status of the patient, i.e. prevention of~     graft failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients.~      The conditioning proposed combines myeloablative drugs with a favorable safety profile such~     as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the~     traditional immediate and late toxicity of busulfan and cyclophosphamide.~   "
95209|NCT01810913|"~     This randomized phase II/III trial studies how well radiation therapy works when given~     together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in~     treating patients with stage III-IV squamous cell head and neck cancer. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or transmit tumor killing~     molecules to them. It is not yet known whether radiation therapy is more effective when~     given with cisplatin, docetaxel, or cetuximab and docetaxel.~   "
95210|NCT01810900|"~     This multicenter, randomized, single-blind study assessed the safety and efficacy of~     Protescal for the reduction of post-operative adhesion formation following myomectomy.~   "
95211|NCT01810887|"~     The purpose of this study is to evaluate the pharmacokinetics (explores what the body does~     to the drug) and safety of darunavir, and will be administered in combination with Ritonavir~     in healthy adult Japanese male participants.~   "
95212|NCT01810874|"~     The purpose of this study is to determine whether the extraperitoneal approach is better~     than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical~     staging of endometrial or ovarian cancer.~   "
95213|NCT01810861|"~     The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae~     that causes invasive diseases at children and adults in Turkey.~   "
95214|NCT01810848|"~     Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the~     joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an~     effusion. Over 40 million Americans also have cardiovascular disease in addition to their~     OA. Initiation and maintenance of even low-levels of physical activity is critical for~     management of cardiac risk. Patients with osteoarthritis have been shown to have poorer~     aerobic conditioning, lower daily physical activity levels and lower self-efficacy for~     exercise than non-OA cohorts.~      It has been established that there exists a consistent gradient across activity groups~     indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active~     individuals. Available research suggests the greatest gains in cardiovascular fitness occur~     in moving a sedentary individual to even low levels of physical activity, and 12 weeks is~     enough to demonstrate change in the risk profile of at-risk individuals.~      Finally, appropriate levels of aerobic and strength training have been shown to be~     beneficial in treatment of osteoarthritis of the knee. This study will evaluate the~     effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of~     physical activity and fitness as measured by MET level compared to an exercise-only cohort;~     evaluating both the change in physical function as well as the cardiovascular risk profile.~     This is a randomized, single-blinded clinical trial comparing injection of the knee joint~     with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6~     months following randomization.~   "
95215|NCT01810835|"~     The prevalence of HBsAg carriage in pregnant women varies in France, according to the native~     country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 %~     in Parisian area). The level of HBV-DNA varies according to HBe status and geographical~     origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT).~     It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was~     0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in~     newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at~     birth. Thus, data are needed concerning the current practices about the prevention of HBV~     MTCT in France, and their results.~   "
95216|NCT01810822|"~     Oxidative stress is involved in the pathophysiology of diabetic nephropathy. The~     superoxide-generating nicotinamide adenine dinucleotide phosphate-oxidase 2 (NOX2, encoded~     by the CYBB gene) and the antioxidant enzyme glutathione peroxidase 4 (GPX4) play opposing~     roles in the balance of cellular redox status. In the present study, we investigated~     associations of single nucleotide polymorphisms (SNPs) in the regulatory regions of CYBB and~     GPX4 with kidney disease in patients with type 1 diabetes.~   "
95217|NCT01810809|"~     Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation~     is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial~     joints. The dosis regimen is well established for the knee joint, but there is still no~     consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to~     determine the optimal dosis for hip viscosupplementation~   "
95218|NCT01810796|"~     Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin~     elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood~     pressure or heart rate, prevents postoperative myocardial injury.~   "
95219|NCT01810783|"~     To determine the safety and efficacy of brexpiprazole during long-term treatment.~   "
95220|NCT01810770|"~     To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223~     dichloride in an Asian population of subjects with CRPC metastatic to the bone.~   "
95221|NCT01810757|"~     Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause~     significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are~     unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but~     would have a normal life expectancy if their cancer were adequately controlled.~     Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions~     and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not~     an option.~      Radiotherapy treatment is planned based on information from a CT scan which shows the~     position and shape of the bladder. This plan needs to take into account the fact that the~     bladder's shape and position can change, depending on how full it is and because of where it~     is in relation to the bowel. A safety margin is therefore added around the bladder on the~     planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.~      It is now possible to take scans of the bladder's position before each treatment and adjust~     the position of the treatment plan accordingly to ensure the bladder is fully covered by it.~     In this study we are also looking at whether it is possible to design a series of treatment~     plans with different size safety margins and then choose one that fits best for each~     particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate~     treatment delivery using smaller safety margins and this might help to reduce side effects.~      Aims~      In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:~        1. whether treatment using adaptive planning can be successfully delivered at multiple~          sites across the UK and results in acceptable levels of toxicity~        2. the local tumour control rate achieved by hypofractionated weekly radiotherapy~        3. the requirement to treat with adaptive planning.~      How results will be used Results will provide robust evidence for use of hypofractionated~     radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient~     population. The randomised element of the trial will support the implementation of~     image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide~     evidence on the benefits or otherwise of this methodology and inform the development of~     further trials in this and other patient groups.~   "
95222|NCT01810744|"~     The treatment of the most common cancers (colon, breast, lung, liver and kidney) has~     recently added a new therapeutic class known as the anti-angiogenic. It was born from a~     better understanding of tumor growth requires the development of neo-vessels. These new~     vessels are of major importance for the viability of the tumor but also the birth of~     metastases. This neo-angiogenesis is complex and results from an imbalance between~     pro-angiogenic factors and anti-angiogenic factors. Growth factor VEGF and its receptors~     (VEGFR-1, VEGFR-2 and VEGFR-3) are a way of survival of endothelial cells required for tumor~     neoangiogenesis. The anti-angiogenic drugs currently available on the market are bevacizumab~     (Avastin ®), sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of~     anti-angiogenic action of these three main drugs are pharmacological inhibition of the VEGF~     pathway.~      These new anti-angiogenic therapies, however, have significant adverse effects are common~     and some other more serious but rare.~      Hypertension is the most common side effect observed in patients treated with anti-VEGF.~     This is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely~     compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious~     consequences malignant hypertension, severe hypertension refractory reversible posterior~     leukoencephalopathy associated with severe hypertension have also been reported.~      The pathophysiology of hypertension may be due to the neutralization of major physiological~     effects of VEGF in endothelial cell and therefore the vascular wall.~      The study of the microcirculation is not only useful in the diagnosis of microvascular but~     also macrovascular disease in the evaluation of chronic arterial and venous severe it~     determines the prognosis. In these indications, capillaroscopy remains the gold standard for~     all work pathophysiological because visualization of phenomena measured avoids artifacts and~     difficulties of interpretation. It then appealed to additional technology to directly~     measure the capillary pressure, capillary flow velocity, and indirectly assess capillary~     permeability and function of lymphatic canaliculi. The simplest of these technological~     inputs: video microscopy and digital image analysis, have also improved the practice of~     routine clinical capillaroscopy in its main field of application, evaluation of~     microangiopathy connective. The examination can be performed more quickly and easily~     archived and quantified.~      Only two studies on 14 and 16 patients were able to see a decrease in capillary density~     correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.~      Thus, we propose to quantify in a number of relatively large patient patients the decrease~     in capillary density as well as the relationship between the decrease in the number of~     capillaries and anti-tumor response.~      The study will also aim to measure the prevalence of hypertension in patients treated with~     bevacizumab and to establish the link between these data and the modification of the~     capillary microcirculation.~   "
95223|NCT01810731|"~     In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women~     are the most important risk group for season influenza vaccination based upon compelling~     evidence of substantial risk of severe disease in this group and evidence that seasonal~     influenza vaccine is safe and effective in preventing disease in pregnant women as well as~     their young infants, in whom disease burden is also high. Recent data from Kenya, similarly~     suggest rates of influenza-associated hospitalizations in children under age 1 to be as~     high, or higher, than those observed in the United States. However, TIV may have reduced~     immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental~     transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a~     double-blind randomized controlled trial of influenza vaccines stratified by HIV status in~     up to 720 pregnant women in their second and third trimesters and their infants residing in~     health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We~     propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double~     dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal~     influenza vaccination policies in Kenya and other African countries.~   "
95224|NCT01810718|"~     Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late~     non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a~     standard satisfactory treatment for these patients does not exist. cGVHD is an~     immune-mediated disease, resulting from a complex interaction between donor and recipient~     adaptive immunity, but its exact pathogenesis is still incompletely defined.~      The purpose of this study is to determine safety and efficacy of Nilotinib in a population~     with steroid-refractory/or steroid-dependent cGvHD with a phase I study.~      In phase II the MTD will be used to define the efficacy of Nilotinib in a cGvHD steroid-~     refractory or steroid dependent population, with the same characteristics of the previously~     Imatinib-treated population.~   "
95225|NCT01810705|"~     The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells) to~     standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed~     with AML and unfit for intensive chemotherapy.~      The investigators Assume a 75% improvement in median Progression Free survival (PFS) in the~     L-asparaginase (GRASPA) plus low-dose cytarabine group compared to median PFS in the~     low-dose cytarabine group (control).~   "
95226|NCT01810692|"~     In COPD the patient's ability to use inhalers correctly and their preference for the inhaler~     are both important factors in selecting an appropriate treatment for COPD. This is a~     cross-sectional study where satisfaction, preference and handling of two different devices~     such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD~     patients~   "
95227|NCT01810679|"~     To demonstrate the safety and effectiveness of the Perceval S heart valve when used to~     replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.~   "
95228|NCT01810666|"~     Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand~     treatment for children with severe Hemophilia A.~   "
95229|NCT01810653|"~     The study design combines a long-term safety and a dose range determination objective. The~     first 8 weeks of the study were primarily intended for the dose range determination, while~     the later visits were used for the comparison of long-term safety between the groups.~   "
95230|NCT01810640|"~     This study's objective is to obtain preliminary data to test the hypotheses that~     percutaneous liver biopsy in brain death donors is safe and provides reliable histological~     information. Furthermore, that information when disseminated fully and widely many hours~     before organ recovery would not only decrease economic costs of wasteful recovery of livers~     that are not ultimately transplanted but also increase transplantation and decrease cold~     ischemia times of recovered livers.~   "
95231|NCT01810627|"~     This is a non-randomized study to evaluate the utility of MVCT as a quality assurance~     measure in patients treated with interstitial permanent seed implants for low and~     intermediate risk prostate cancer. All patients will received the same standard of care~     treatment but will receive an additinoal CT image of the prostate.~   "
95232|NCT01810614|"~     Recent evidence has shown that kidney volume predicts the likelihood of developing renal~     insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth~     of cysts and the harm they do to kidney function. Recent studies indicate that the rate of~     kidney volume increase is hastened by excess dietary protein, salt, and potential net acid~     precursors, and slowed by increased water intake sufficient to lower plasma vasopressin~     levels.~      Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the~     end-stage, but there is currently no specific diet prescription that takes potentially~     harmful dietary elements into account for ADPKD patients in the earliest stages of the~     disease. This study will examine a novel diet for ADPKD created by the researcher termed the~     ADPKD diet.~   "
95233|NCT01810601|"~     To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy~     rates versus clinical touch technique~   "
95234|NCT01810588|"~     In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord~     transplant is a novel and promising way to improve transplant outcomes. We hypothesize that~     identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA)~     targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective~     recipient) is more important to the outcome of haplo cord transplant than the nucleated cell~     dose. The identification of such a graft for a large proportion of the subjects may~     necessitate accepting a lower umbilical cord graft dose.~      In addition to a umbilical cord blood transplant, recipients will receive stem cells from a~     family member ( a haplo-identical donor) . After collection and prior to infusion, these~     cells will be purified using a device called a CliniMACS CD34 selection device. The subject~     will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental~     drugs are used in this study, and the combinations of drugs that will be used in the~     conditioning regimen are combinations that have been used in the past.~   "
95235|NCT01810575|"~     The purpose of this study is to assess the safety & efficacy of a single dose of alprostadil~     cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile~     dysfunction.~   "
95236|NCT01810562|"~     The purpose of this study is to determine whether tactile stimulation for reduced~     sensibility of the affected extremities after stroke has effect.~      Hypothesis:~      Stimulation of sensibility after stroke will have a significant contribution for improved~     sensibility. Without any stimulation, no signal is sent to the brain and there is no need~     for the healthy parts of the brain to adapt this function. Stimulation of the sensibility~     over a period of time on both sides of the body, gives the brain signals and the opportunity~     to compare how the signals should be recognized. New connection will be able to interpret~     signals correctly.~   "
95237|NCT01810549|"~     The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of~     a high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented~     by inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.~   "
95238|NCT01810536|"~     Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental~     oxygen is usually required. We will compare a new high flow nasal cannula system with~     Venturi masks for oxygen supplementation to patients with CF hospitalized for respiratory~     exacerbation.~   "
95239|NCT01810523|"~     Study will test the use of narratives on patient satisfaction and translation of an~     evidence-based approach to the use of X-rays for leg injuries in the Emergency Department~     (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom~     X-rays are determined to not be needed. On discharge, patients will receive the current~     fact-based sheet or that plus a narrative explaining the work-up and treatment of these~     injuries. Outcomes will be assessed by a survey measuring patient satisfaction and~     understanding.~   "
95240|NCT01810510|"~     The purpose of this study is to determine whether two modes of artificial (i.e. mechanical)~     ventilation have an impact on patient synchrony with the ventilator (breathing machine) and~     on the patient's work of breathing.~   "
95241|NCT01810497|"~     The aim of the study is to investigate the possible influence of different durations of use~     of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty.~     We hypothesize that the duration of elastic bandage use has no significant influence on the~     incidence of relapse of prominence of the ears and need for reoperation.~   "
95242|NCT01810484|"~     Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study~     treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or~     CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment.~     Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at~     each follow-up visit.~   "
95243|NCT01810471|"~     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim~     of our study is to quantify the stabilizing effect of different devices. Through the use of~     a foot measurement model in 3D motion analysis the influence of the devices with respect to~     a mechanical effect is examined by means of different tests. The dynamic postural control is~     quantified. The hypothesis was that the devices would stabilize differently the foot~     segments.~   "
95244|NCT01810458|"~     We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver~     injury which is not detected by the usual blood tests used to look at liver function. This~     ongoing liver injury leads to cirrhosis in a significant number of adults with AAT~     deficiency.~   "
95245|NCT01810445|"~     The purpose of this pilot study is to develop the methodology for an innovative subsurface~     imaging technology that was designed at Lawrence Livermore National Laboratory. It will~     allow the non-invasive analysis and imaging of tissues and chemical distributions in the~     body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.~   "
95246|NCT01810432|"~     The purpose of this study is to measure how much of the drug gets into the blood stream and~     how long it takes the body to get rid of it when given to healthy participants. Information~     about any side effects that may occur will also be collected.~      The study has 2 periods. In each period, participants will take the study drug for 10 days,~     either with or without a meal. There is a minimum 14 day washout between each period.~      This study is approximately 50 days, not including screening. Screening is required within~     28 days prior to the start of the study.~   "
95956|NCT01801124|"~     Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the~     Transversus Abdominis Plane (TAP).~   "
95247|NCT01810419|"~     In internal medicine, assessment of spleen size on physical examination is an extremely~     important part of the overall evaluation of patients with many illnesses. Examination of the~     spleen is also one of the core competencies that the investigators expect our students and~     residents to learn as part of their training. Unfortunately, the sensitivity and specificity~     of examination of the spleen at the bedside is not very good. The investigators wish to~     determine if handheld ultrasound can accurately assess spleen size. Doing so would make~     physical examination of the spleen obsolete and transform training objectives for medical~     students and residents.~   "
95248|NCT01810406|"~     Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the~     cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space~     to continue to give pain relief medication. During a CSE, after injection of the medication~     in the CSF and before inserting the epidural catheter, if normal saline is injected into the~     epidural space, there may be an increase in pain relief and an increase in the level of~     numbness. This injection of saline in the epidural space to increase pain relief and~     numbness is termed epidural volume extension (EVE). The purpose of this study is to~     determine if there is a benefit for EVE to improve labor analgesia (pain relief) using CSE~     in pregnant laboring patients.~   "
95249|NCT01810393|"~     This open-label, randomized, multicenter study will evaluate participant preference for~     subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with~     HER2-positive metastatic breast cancer responding to first-line treatment with IV~     trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles~     (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3~     cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will~     receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or~     until disease progression or inacceptable toxicity occurs, whichever comes first.~   "
95250|NCT01810380|"~     To determine the efficacy and safety of brexpiprazole for the treatment of adults~     experiencing an acute episode of schizophrenia.~   "
95251|NCT01810367|"~     Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With~     Cisplatin in first Treatment of NSCLC~   "
95252|NCT01810354|"~     Surgical site infections are common and a cause of major morbidity. They are also more~     common in obese women. Cesarean sections are the most common surgery performed in the United~     States, therefore pregnant women are being faced with this problem frequently. There is~     evidence to show that prophylactically administered antibiotics, cefazolin specifically, to~     obese women prior to cesarean section do not reach adequate concentrations in adipose tissue~     to prevent infection. The purpose of this study is to evaluate if an increased dose of~     cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that~     three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean~     section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain~     adequate adipose tissue concentration compared to two grams of cefazolin.~      Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton~     pregnancy and require a cesarean section for any obstetrical indication. Women will be~     excluded if they have a suspected infection, have a multiple gestation, or have preexisting~     diabetes or hypertension with end organ damage. The subjects will be screened both by~     through the OR schedule as well as through the clinics. They will then be consented and~     enrolled by the primary investigator. Once enrolled the subjects will be randomized to~     receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given~     no more than 60 minutes prior to the start of the surgery.~      Two adipose tissue samples will be obtained at the time of surgery. The first at the start~     after skin incision and the second at the end prior to closure of the skin. There will also~     be a separate IV placed at the start of the procedure from which three blood draws can be~     collected. These three samples will be obtained at the start of the surgery but after~     antibiotic administration, at the time of the first adipose collection, and at the time of~     the second adipose collection. The samples will then be stored at -80 degrees and shipped to~     David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.~      While the subjects are in the hospital recovering from their surgery, a chart review will be~     performed to determine if there are any infections occuring post-operatively. A telephone~     survey will be conducted six to eight weeks postpartum again assessing for any infectious~     complications after the cesarean section.~   "
95253|NCT01810341|"~     This study will prospectively enroll approximately 880 children, at least 18 months and less~     than 60 months of age, who have been referred to a pediatric developmental evaluation~     center. Enrolled children will have blood drawn for RNA gene expression analysis and~     optionally for metabolite, lipid and DNA analysis and undergo a clinical evaluation to~     determine the presence or absence of a diagnosis of ASD.~      The primary objective of this study is:~      - To develop an algorithm to classify blood RNA gene expression patterns to maximize~     agreement between the classification and a clinical assessment of presence or absence of~     Autism Spectrum Disorders (ASD).~      The secondary objectives of this study are:~        -  To develop an algorithm to classify plasma metabolite and/or lipid profiles in such a~          way as to maximize agreement between the classification and a clinical assessment of~          presence or absence of ASD.~        -  To prospectively assess the clinical sensitivity and specificity of the plasma~          metabolite and/or lipid profile classification algorithm in a separate population~          consisting of children referred to a developmental evaluation clinic for a possible~          developmental disorder (DD).~        -  To evaluate clinical sensitivity and specificity of various combinations of gene~          expression signature, metabolite and/or lipid signatures, and presence of~          ASD-associated genetic variation detected by chromosomal microarray analysis (CMA) or~          sequencing protein-coding regions of the genome.~   "
95254|NCT01810328|"~     The purpose of this study is to learn more about how to treat patients with severe injuries~     related to trauma and to prevent failure of vital organs in this patient population.~     Approximately 200 severely injured patients with blunt trauma and 40 healthy volunteer~     subjects will be enrolled in this study. During the study seven blood samples (4-5 mls) will~     be collected from patients who have suffered severe trauma over a 28 day period. A one time~     5 ml blood sample will be collected from the healthy volunteers. Clinical data will be~     collected daily while patients are hospitalized. The initial blood sample must be collected~     from qualifying patients within the first 12 hours of admission to the hospital. The reason~     for blood sampling is to validate a rapid genomic test in real time. Once confirmed, this~     genomic test can be used to identify patients who will have a complicated clinical course~     and would, therefore, be good candidates for interventional, immunomodulatory therapies.~   "
95255|NCT01810315|"~     Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety~     parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator~     use in premenopausal and postmenopausal women.~   "
95256|NCT01810302|"~     The purpose of this study is to determine if intrathecal nicardipine is safe for the~     treatment of cerebral vasospasm.~   "
95282|NCT01809951|"~     The use of soy-isolate protein based formula for infants with cow's milk protein intolerance~     is common in Indonesia, however, there has not been any systematic collection of clinical~     data to determine the formula's gastrointestinal tolerance, and the parent's perceptions~     regarding the formula.~   "
95257|NCT01810289|"~     START is clinic-level (not individual-patient) intervention to catalyze the process of ART~     initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g.,~     adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time~     point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility~     in real time at first presentation to care, (2) targeted knowledge transfer (i.e.,~     dissemination) of recent scientific evidence regarding effects rapid ART initiation on~     survival to front line health care workers; and 3) feedback and reporting to clinic and~     providers. There three components represent empirically validated steps in the PRECEED~     implementation model.~   "
95258|NCT01810276|"~     The objective of this study is to determine if the administration of platelets will improve~     outcome in patients with ICH who are being treated with either aspirin, a thienopyridine~     (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific~     aims:~        1. To determine what affect platelet administration will have on bleeding in the brain.~        2. To determine what affect platelet administration will have on brain function. Several~          assessments to test the functioning of the brain will be performed at enrollment and~          throughout the study. Comparing the results of these assessments between the~          experimental and control groups should allow us to determine if platelet administration~          improves outcomes in patients with bleeding in the brain exposed to antiplatelet~          therapy.~        3. An important risk of reversing antiplatelet therapy is exposing the patient to the very~          complications this therapy was designed to prevent. Therefore, tracking complications~          will be a very important part of this study. The investigators will compare the rates~          of death, heart attack, stroke and clots in the veins between groups.~        4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While~          platelet responsiveness, as measured by a special platelet blood test, will not affect~          enrollment, the investigators feel it will be important to measure.~   "
95259|NCT01810263|"~     The aim of this prospective randomized controlled study is to demonstrate the efficacy of~     Intensive Nutritional Supplement in Patient with Stroke.~   "
95260|NCT01810250|"~     The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands~     initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim~     of this study is to collect clinical information on the performance of the Endurant Stent~     Graft System for endovascular repair in anatomically challenging aneurysms, and to~     critically assess whether the current guidelines for anatomic eligibility to endovascular~     treatment with this system are still applicable. This study aims at creating a database that~     can be pooled/ compared with the ENGAGE database.~      This study aims at answering two major questions:~        1. Is the technical success rate of successful delivery and deployment of the Endurant~          (II) similar in anatomically challenging aneurysm?~        2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or~          does treatment of these aneurysms lead to more complications and reinterventions?~   "
95261|NCT01810237|"~     Research Questions:~        1. Does using dabigatran bridging result in consistent therapeutic anticoagulation? What~          percentage of patients will become subtherapeutic on warfarin once dabigatran is~          stopped?~        2. What is the incidence of bleeding events with the use of dabigatran overlapped with~          warfarin for bridging?~        3. What is the cost benefit of using dabigatran instead of dalteparin for bridging~          anticoagulation?~   "
95262|NCT01810224|"~     This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim~     of this study is to assess the importance of functional assessment of coronary artery~     disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to~     the traditional Angio-guided strategy in the guidance of surgical revascularization by~     aorto-coronary bypass grafting.~   "
95263|NCT01810211|"~     This study will look at which, if any, active stretching procedure is most effective at~     correcting posterior shoulder tightness (PST) in the post-operative population. Posterior~     shoulder tightness can influence shoulder mobility and function within both a symptomatic~     and an asymptomatic population. There are previous studies that have examined the~     effectiveness of different active stretching procedures and their ability to correct PST but~     only in the asymptomatic population. As clinicians it will be helpful to investigate their~     effect within a symptomatic population in order to prescribe appropriate and effective~     stretches within an individual's home exercise program. The study design is a double blinded~     randomized control trial. During evaluation a passive measurement of PST and internal~     rotation will be performed. Another therapist, blinded to the measurements, will randomly~     select which subgroup the individual will be placed in for the first three individuals and~     this sequence will be followed for the remainder of the participants. At this time the~     therapist will instruct the individual on the corresponding exercise which they will perform~     in front of that therapist. The individual will perform this exercise one more time that day~     and twice the following day and once again upon follow up prior to having internal rotation~     and PST measured once again. At this point this will be the conclusion of that individuals~     involvement in the study.~      Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely~     in the post-operative shoulder population.~      Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the~     post-operative population.~      Null Hypothesis2: There is no significant difference in the reduction of PST between the~     horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative~     shoulder population.~      Hypothesis2: There is a significant difference in the reduction of PST between the~     horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative~     shoulder population.~   "
95264|NCT01810198|"~     To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided~     selective catheterization strategy for stable patients but without known CAD and an American~     Heart Association/ American College of Cardiology Class II indication for non-emergent~     invasive coronary angiography.~   "
95265|NCT01810185|"~     The investigators will be looking at the efficacy of the use of once daily use of low dose~     naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.~   "
95266|NCT01810172|"~     Often the decision for chest tube removal or trial of chest tube clamping is based on~     subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring~     and recording of air leaks has been done using digital pleural drainage devices. This~     provides us with objective and continuous recording of air leaks as well as changes in~     pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage~     system will result in shorter hospital stay in comparison to traditional pleural drainage~     systems.~   "
95267|NCT01810159|"~     Primary care settings (PCS) are a missed opportunity for delivering evidence-based~     treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to~     evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD~     treatments in PCS, integrated collaborative care (ICC) and education and resources (E&R).~     The investigators hypothesize that ICC will be more effective than E&R in promoting A.~     Implementation outcomes B. Service system outcomes and C. Patient outcomes.~      Results from our study will help providers choose between two different strategies and~     advance the field of implementation research.~   "
95268|NCT01810146|"~     60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients~     with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a~     type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The~     patients and the volunteers will have a classical pre-operative check-up (fibroscopy,~     oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam,~     lactulose oro-caecal transit exam, intestinal permeability test calculated by~     lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also~     provided for studying permeability. For only patients, samples from the gastric resection~     will be provided for analysing the enteric nervous system and motricity.~   "
95269|NCT01810133|"~     Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status~     (American Society of Anesthesiology) is the most commonly scale to assess this parameter and~     has yet been repeatedly criticized in the past for its discriminatory power.~      Few studies have shown both the ASA physical status and the more detailed and more~     time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.~      The purpose of this observational study is to compare the predictive value of both scales~     with regards to all-cause in-hospital mortality and hospital length of stay.~   "
95270|NCT01810120|"~     Allocation: Non-Randomized Endpoint Classification: Safety/Feasibility Intervention Model:~     Single Group Assignment Masking: Open Label Primary Purpose: Treatment Study to assess the~     feasibility and safety of the infusion of a T cells receptor (TCR) alfa beta depleted graft~     in pediatric patients affected by malignant and non-malignant hematological disorders and~     receiving an Hematopoietic stem cell transplantation (HSCT) from a Human leukocyte antigen~     (HLA) partially matched family donor.~   "
95271|NCT01810107|"~     The specific aim of this study is to develop a growth and development chart (similar to a~     height or weight chart for children) that identifies the pattern of development of the~     pediatric vocal cord lamina propria from a single to a three layer structure. A secondary~     aim is to identify whether this growth chart shows a pattern of linear development or~     whether there are clear critical periods of development.~   "
95272|NCT01810094|"~     Spinal injuries, such as vertebral fractures, often result in a significant instability of~     the spine and lead to acute or delayed neurological deficits. Depending on the type of~     injury there are various methods available to stabilize the spine. The proposed study should~     clarify whether the combined reduction and fixation with a minimally invasive approach can~     actually be done with the same precision as in a conventional approach. The primary endpoint~     of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance~     over the first 6 postoperative weeks. It is the aim of the study to gather key radiological,~     clinical and subjective patient outcome parameters for its patient population that will~     allow to compare the results to a historical group of patients. The study design is~     non-interventional, prospective, open,and multicentric.~   "
95273|NCT01810081|"~     In this study, the presence of H.Pylori in the gallbladder mucosa of patients with~     symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori~     infection of the gastric mucosa was also investigated to study the relationship of gastric~     H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric~     mucosa may have a role in the formation of gallstones.~   "
95274|NCT01810068|"~     The impact of of different surgical treatment modalities of benign prostatic hyperplasia in~     men on their sexual function is not well studied.~      The investigators will investigate prospectively the effect of conventional monopolar~     transurethral resection of the prostate (TURP), bipolar TURP and Holmium laser enucleation~     on urinary and sexual functions.~   "
95275|NCT01810042|"~     Exudative age-related macular degeneration (ARMD) is complicated by choroidal~     neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the~     gold standard treatment, recurrence is the main limitation of the treatment. The changes of~     the CNV vascular structure is expected to provide information regarding recurrence. In the~     eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA),~     the vascular changes after ranibizumab injections will be investigated prospectively.~   "
95276|NCT01810029|"~     The overall hypothesis of this study is that a cardiac rehabilitation program with~     meditation will be more effective than cardiac rehabilitation alone in improving blood flow~     through the diseased coronary arteries in African Americans. For this purpose, 56 African~     American men and women with coronary heart disease will be randomly assigned either to~     standard cardiac rehabilitation plus the Transcendental Meditation program or to standard~     cardiac rehabilitation alone. The treatment period will be 12 weeks in length.~   "
95277|NCT01810016|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     Ipilimumab i.v. followed by NY-ESO-1 Protein vaccine with Poly-ICLC and Montanide s.c. (Arm~     A), or NY-ESO-1 OLP4 vaccine with Poly-ICLC and Montanide s.c. (Arm B), or NY-ESO-1 OLP4~     vaccine mixed with Poly-ICLC without Montanide s.c.(Arm C).~   "
95278|NCT01810003|"~     Subclinical inflammation is now indisputably recognized as a key etiological factor in the~     development of atherosclerosis and subsequent cardiovascular disease. Obesity and related~     dysmetabolic states including metabolic syndrome (MetS) are highly prevalent causes of~     subclinical inflammation. Obesity and MetS are both diet and lifestyle-related and there is~     a growing body of literature suggesting that specific nutrients, such as long chain omega-3~     polyunsaturated fatty acids (LCn-3PUFA), may attenuate the pro-inflammatory state associated~     with these conditions. However, careful review of existing literature on this topic reveals~     important gaps in knowledge, the purported anti-inflammatory effects of LCn-3PUFA even being~     questioned by many. Significant confounding attributable to study design, sample size and~     biomarker selection may be responsible in part for inconsistencies in the literature on~     LCn-3PUFA and inflammation. We also found that evidence available to date (for and against)~     is based primarily on secondary analyses, as most of the studies published were not~     primarily designed to investigate inflammation as a primary outcome. It remains unclear~     whether the different LCn-3PUFA, primarily docosahexaenoic acid (DHA, 22:6n-3) and~     eicosapentaenoic acid (EPA, 20:5n-3), have similar effects on pro-inflammatory processes as~     almost all studies were undertaken using a mix of LCn-3PUFA. Whether efficacy of EPA and DHA~     is influenced by sex/gender is also unknown. Finally, a better understanding of the systemic~     and tissue-specific mechanisms underlying the anticipated anti-inflammatory effects of~     different LCn-3PUFA in MetS would also be of great value. Addressing these gaps has~     important public health implications, considering that LCn-3PUFA supplements are broadly and~     indiscriminately recommended for the prevention of cardiovascular disease.~      The overarching objective of the proposed research is to compare the anti-inflammatory~     effects of EPA and DHA in men and women with MetS.~   "
95279|NCT01809990|"~     The main goal of this trial is to study the feasibility and effectiveness of~     internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive~     disorder.~   "
95283|NCT01809938|"~     Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee,~     the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this~     study is to demonstrate whether there is really a delay in gastric emptying time associated~     with the inclusion of milk in a cup of tea.~   "
95284|NCT01809925|"~     This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover~     design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber~     supplement powder dissolved in water versus placebo on satiety measures in healthy~     volunteers. This study will be conducted at a single study site.~   "
95285|NCT01809912|"~     To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in~     patients with solid tumors for which no standard therapy is available.~   "
95286|NCT01809899|"~     The overall goal of the proposed study is to insure the protection and safety of human~     subjects who have been previously exposed to interpersonal traumatic events and who are~     participants in symptom provocation research. The investigators intend to examine trauma~     history, cognitive, interpersonal, and genetic predictors of participants' unfavorable~     reaction to participation in research involving trauma-related script-driven imagery (SDI).~     The design includes comparing participants in a consent as usual group to participants in an~     enhanced consent group to see which minimizes unfavorable effects of participating in a~     research provocation study. In addition, the two different consent groups will be assessed~     for their effects on psychobiological and neurobiological stress response. Furthermore, the~     investigators will examine the relationship between the psychobiological responses and~     neural mechanism during SDI, and unfavorable reactions to participation in symptom~     provocation research.~   "
95287|NCT01809886|"~     The purpose of this clinical trial is to prove that the administration of sugammadex at a~     dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response~     and post-tetanic count (PTC) < of 2 induced and maintained with Rocuronium in pediatric~     patients for short-term elective surgery.~   "
95288|NCT01809873|"~     This project aims to test an innovative, sustainable financial incentive designed to reduce~     the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.~   "
95289|NCT01809860|"~     The purpose of the study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of sirolimus after single dose administration.~   "
95290|NCT01809847|"~     To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of~     allogeneic HCT in CLL~   "
95291|NCT01809834|"~     Evaluation of two contact lenses~   "
95292|NCT01809821|"~     Sleep is an essential component of good physical and mental health. Previous studies have~     reported that poor quality sleep is associated with an increased risk of hypertension,~     stroke and cardiovascular disease (CVD). Hypertension is the most common and important risk~     factor for CVD, and even modest reductions in blood pressure result in significant~     reductions in stroke and myocardial infarction. In this randomised trial, the investigators~     aim to evaluate whether a simple, multi-component, online sleep intervention reduces blood~     pressure in patients with essential hypertension.~   "
95293|NCT01809808|"~     The purpose of this study is to evaluate hormone values and other markers of disease~     activity in a cohort of patients with acromegaly at the time of diagnosis and then~     prospectively after surgical or other treatment. This study is designed to determine blood~     levels of growth hormone and related hormones and cardiovascular risk markers as well as~     signs and symptoms of the disease at diagnosis and how these parameters change over time~     after surgical or other therapy. The investigators will also obtain hormonal data in a group~     of 50 healthy subjects who will each be studied just once with an oral glucose tolerance~     test (OGTT). These data will provide a comparison group to the acromegaly subjects.~   "
95294|NCT01809795|"~     The purpose of this study to determine if adding blueberries to obese children's diet will~     improve weight status and other medical testing. We would also like to determine if a larger~     research study involving blueberries is possible.~   "
95295|NCT01809782|"~     Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing~     two-time liver resection.~   "
95296|NCT01809769|"~     Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for~     each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following~     initial injection.~   "
95297|NCT01809756|"~     Rationale: In the Netherlands 1731 people are being diagnosed with SCLC (Small Cell Lung~     Cancer) in 2010. This is approximately 14% of all new diagnosed lungcancers. Part of them~     will need a combination of chemo-radiationtherapy. A review of the incidence and severity of~     esophagitis in SCLC patients receiving a combination of chemotherapy and once daily~     radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2~     and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3~     weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are~     likely to arise earlier and become more severe.~      Mucositis of the upper tractus digestivus is a serious adverse event leading to pain,~     problems with swallowing and decreased food intake. It has a negative infect on QoL and can~     lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements~     in treatment modalities to improve these daily patient toxicities.~      Caphosol® is an advanced electrolyte solution indicated as an adjunct to standard oral care~     in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects~     of Caphosol® oral rinse 4 times daily in a study with head and neck chemoradiation patients~     were found on the presence of mucositis and on oral comfort.~      It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same~     for the whole tractus digestivus. The appearance does differ due to differences in cell~     proliferation.~      Swallowing Caphosol® after oral rinse could have a positive effect on esophageal mucositis~     on time of onset, severity and duration.~      Objective: Adding the use of Caphosol® (rinsing and swallowing four times a day) to the~     standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and~     severity of esophagitis in SCLC patients, comparing to the standard of care alone.~      Study design: A multi-centre, open, randomized prospective phase II study. Study population:~     108 patients 18 years or older with histologically proven SCLC (all histological subtypes),~     treated with concurrent chemo- and radiotherapy are estimated to be included in this study~     (2:1 ratio inclusion; 72 patients with Caphosol® and 36 patients without Caphosol®; α=0.05,~     power 80%).~      Intervention (if applicable): 108 patients eligible for this study will be monitored during~     their SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®, 4~     times a day - next to the standard of care. Caphosol® will start at day 1 of treatment and~     will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36~     patients will receive only the current standard of care for esophagitis. The patients will~     be randomly assigned to one of the groups.~      Main study parameters/endpoints: The primary objective is to estimate the incidence, onset,~     duration and severity of esophagitis in SCLC patients undergoing radiation therapy with~     chemotherapy who receive Caphosol®.~      Secondary study parameters/outcome of the study (if applicable):~        1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia,~          analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)~        2. Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the~          burden and risks associated with participation, benefit and group relatedness: The~          risks are very small. The patient has to fill in a Esophagitis Daily Questionnaire and~          during regular visits QOL questionaires are performed.~      Sputumswabs are collected on a weekly basis for determination of the microbiological flora~     of the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic~     status research.~      Caphosol® is a saturated calciumphosphate solution. The daily intake of calcium and phosphor~     when swallowing Caphosol® 4 times daily is far beyond the Acceptable Daily Intake (ADI)(<~     5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat~     (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol® is~     negligible and is considered safe.~   "
95298|NCT01809743|"~     The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady~     state hyperemia as compared to central venous infusion of adenosine for assessing fractional~     flow reserve. (adenosine is considered to be the gold standard)and to investigate the time~     intervals of maximum hyperemia induced by centrally and peripherally administered~     Regadenoson.~   "
95299|NCT01809730|"~     This is a non-randomized, non-interventional pilot observational study designed to follow~     high-risk patients through their surgical and hospital stay. The investigators will collect~     2 4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers -~     inflammatory, metabolic, hypercoagulable and platelet.~   "
95300|NCT01809717|"~     This study will establich the feasibility of weight lifting exercise among patients with~     multiple myeloma, determine if weight lifting exercise increases lean body mass among~     patients with multiple myeloma and obtain further preliminary data on toxicity and~     pharmacokinetics of high-dose melphalan.~   "
95301|NCT01809704|"~     To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the~     commercially available Cirrus~   "
95302|NCT01809691|"~     The purpose of this study is to compare overall survival in newly diagnosed metastatic~     prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700~     versus ADT + bicalutamide.~   "
95303|NCT01809678|"~     This study examines the efficacy of yoga as a complementary therapy for smoking cessation~   "
95304|NCT01809665|"~     This investigation is designed to provide supporting evidence for the clinical safety of the~     Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T~     (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic~     resonance imaging) conditions.~   "
95993|NCT01800643|"~     The purpose of this prospective study is evaluate the best dose of busulfan for each patient~     undergoing Haematopoietic Stem Cell Transplantation~   "
95305|NCT01809652|"~     The purpose of this study is to gain real world, live implant experience with the remote~     implant support system. This system is intended to provide the technical support for device~     implants from a remote location through telepresence (audio and video) and remote control.~     Specifically, the goals of this study are to corroborate bench testing, assess the~     performance of the system, gain understanding of the workflows, customer experience, and~     logistics.~      The intent of the remote support model is to provide the same support that would typically~     be provided by a local support person, only remotely. As such, the remote support person~     would only perform actions that a local support person would routinely do under the~     direction of a physician. This may involve observing patient data, providing technical~     support and advice, and performing testing and device reprogramming via remote control of~     the programmer.~   "
95306|NCT01809639|"~     Concussions are a common injury among athletes in the United States. The annual incidence of~     sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8~     million, and the likelihood of an athlete in a contact sport experiencing a concussion is as~     high as 20 percent per season. Even mild traumatic brain injury, including concussion, can~     cause long-term cognitive problems that affect a person's ability to perform daily~     activities and to return to school or work. Far more concerning is the mounting body of~     evidence that concussions are not just transient injuries - but have cumulative effects. It~     has been well established in animal models that progesterone has neuroprotective benefits.~     Animal studies using progesterone for acute post-injury treatment have demonstrated reduced~     cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved~     behavioral outcomes. To date, there have been no studies to assess whether or not~     progesterone will be effective for the treatment of concussions. This double-blind placebo~     controlled trial will assess the ability of 5 days of oral micronized progesterone~     (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion.~     The investigators hypothesize that athletes treated with progesterone will have faster~     resolution of their concussive symptoms. The investigators believe this study may be the~     first clinical trial to show an effective treatment for concussion.~   "
95307|NCT01809626|"~     The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan,~     one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in~     individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the~     treatment of major depressive disorder. Specifically, levels of the brain chemical GABA will~     be examined in the anterior cingulate and thalamus, two brain regions that play important~     roles in mediating some of the effects of depression and sleep-related drugs, respectively.~     Depressed individuals typically have lower levels of GABA than the healthy population, and~     antidepressant treatment has been shown to help normalize this neurochemical in conjunction~     with improved mood. Given that individuals maintained on SSRIs often are prescribed~     sedative/hypnotics to treat concurrent insomnia, understanding a possible neurochemical~     interaction between them, whether beneficial or harmful, is important for informing~     evidence-based treatment strategies to treat the co-morbid patient. Zolpidem's effects on~     GABA in participants who are maintained on SSRIs will be compared to baseline GABA levels in~     these individuals (i.e., following placebo administration). Two separate scanning sessions~     lasting approximately 45-60 min each will take place within one single study visit in order~     to obtain these measurements using proton magnetic resonance spectroscopy (1H MRS). This~     type of neuroimaging is like an MRI in that it is non-invasive, but it permits us to obtain~     information about chemicals in the brain. A secondary goal of this study is to compare the~     subjective drug effects, or how individuals feel, following the intervention. These measures~     will be used to determine the existence of brain-behavior relationships in order to assess~     the extent to which modulating GABA with zolpidem has effects on mood states in depressed~     participants. Collectively, this study will contribute to our understanding of how these~     drugs exert their effects when one is administered in the presence of the other, and it will~     demonstrate that imaging is an important tool for informing us about how drug effects in the~     brain ultimately result in behavior.~   "
95308|NCT01809613|"~     This study is investigating the usefulness of using functional magnetic resonance imaging~     (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease,~     Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The~     study may determine the relationship between patterns of brain activation and therapeutic~     outcome and/or side effects.~   "
95309|NCT01809600|"~     This retrospective study is aimed at evaluating the safety and efficacy of~     rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or~     high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large~     B-cell lymphoma and BL.~   "
95310|NCT01809587|"~     The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating~     the bowel movement frequency~   "
95311|NCT01809574|"~     We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients~     would lead to a more accurate diagnosis and consequently alterations in treatment regimens~     that may lead to improved outcomes.~   "
95312|NCT01809561|"~     The purpose of the study is to assess the telomere array of different endometriosis tissue~     and endometrium from women with endometriosis compared to healthy women.~      Our hypothesis is that telomere shortening and high telomerase activity will be found in~     tissues from women with endometriosis.~   "
95313|NCT01809548|"~     Introduction: Preterm infants with a birth weight less than 1500 grams have special~     nutritional needs in comparison to full-term neonates. During their stay in the neonatal~     intensive care unit an increased supply with energy, protein and electrolytes is necessary~     to establish adequate growth. After discharge from the hospital special breast milk~     supplements or post discharge formulas are available to cover the special nutrient~     requirements. Complementary feeding in preterm infants is an unexplored field so far and~     nutritional concepts for the first year of life are not available. Data concerning the~     optimal time for starting solid foods are missing as well as information concerning the~     ideal composition of complementary food. In this context it is essential to meet the special~     nutritional needs of Ex-Preemies on the one hand and avoid overfeeding and later obesity~     on the other hand. So far it remains unclear, what the safe time point for introduction of~     solid food to premature infants is and whether this time point influences growth, body~     composition, neurodevelopmental outcome or the incidence of atopic disease.~   "
95314|NCT01809535|"~     Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of~     esophageal variceal rebleeding. However, the optimal interval of EVL remains unclear. Our~     previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an~     appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many~     shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed~     at intervals of 1-2 weeks. So far the optimal treatment interval remained unknown. The~     investigators hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention~     of esophageal variceal rebleeding in cirrhotic patients.~   "
95319|NCT01809470|"~     The study is investigating the metabolic response to playing competitive non-violent and~     competitive violent video games. The primary hypothesis is that the metabolic response in~     the violent game group will differ from the other two groups, due to activation of the~     stress response. The investigators are using an experimental approach, whereby 72 young men~     are randomised to one of three groups: watching television (TV), playing the non-violent~     video game 'FIFA2013', or playing the violent video game 'Call of Duty'. Participants arrive~     fasted, and are given a standardised breakfast. After measurements of weight, height and~     waist girth, they then are assigned to one of the three groups. Baseline blood pressure,~     heart rate and appetite/mood data are collected, along with a saliva sample for measurement~     of the 'stress' hormone, cortisol. The investigators will collect these data again at 4~     time-points during the one hour game-playing session. At the end of the study, the allow the~     participants half an hour of rest, during which they can choose from a variety of sweet or~     savoury snacks. The investigators will compare the data from the three groups, to test~     whether changes in blood pressure, heart rate and salivary cortisol, as well as snack~     consumption, are greater in the group playing the violent game.~   "
95320|NCT01809457|"~     to investigate the effectiveness of the educational poster regarding knowledge of dental~     trauma for the secondary school students~   "
95321|NCT01809444|"~     The aim of this study is to compare the efficacy and safety of prednisone versus~     sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe~     Graves' Orbitopathy (GO).~   "
95322|NCT01809431|"~     The purpose of this study is to determine whether a 14 week intervention is successful in~     improving outcomes for women with gestational diabetes mellitus and their infants.~   "
95323|NCT01808378|"~     Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated~     keratopathy~   "
95324|NCT01808365|"~     This carriage study aims to evaluate the presence of meningococcus in Asian populations (and~     potential for disease) and explore the extent and serogroup distribution of meningococci~     circulating in the population.~   "
95325|NCT01808352|"~     Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client~     Centered Care Coordination (C4)Component.~   "
95326|NCT01808339|"~     This study will investigate the effects of altering the time of day of dosing (morning or~     evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via~     a dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a~     repeat-dose, double-blind, randomized, placebo-controlled, three-way crossover study to~     compare the effect of morning (AM) and evening (PM) dosing with FF 100 on lung function.~     Twenty-four male and female subjects with persistent bronchial asthma will be enrolled to~     ensure twenty evaluable subjects. The three treatments will be FF 100 AM (with placebo PM),~     FF 100 PM (with placebo AM) and matching placebo (AM and PM). All treatments will be~     administered for 14 (+/-2) days with 14 day run-in and 14 to 21 day washout periods. The~     total duration of the study will be approximately 13 to18 weeks for each subject.~   "
95327|NCT01808326|"~     This study is an open-label, single arm, phase II study of chlorambucil in subjects with~     previously untreated CLL.~      The primary objective is to evaluate the response to chlorambucil in Japanese subjects with~     previously untreated CLL.~      Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil~     in Japanese subjects.~   "
95328|NCT01809405|"~     To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual~     Function(QSF) version in Korean language of the cancer patients.~   "
95329|NCT01809392|"~     Allo - hematopoietic stem cell transplantation is currently the only way to cure~     myelodysplastic syndrome /acute leukemia . The existing experimental results showed that~     decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in~     vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models.~     Reasoning that decitabine might selectively augment a graft versus leukemia effect, the~     investigators used decitabine administration after allogeneic stem cell transplantation to~     studied the immunologic sequelae.~   "
95330|NCT01809379|"~     This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure~     chemotherapy in women with recurrent ovarian cancer~   "
95331|NCT01809366|"~     Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases~     uterine receptivity.~   "
95332|NCT01809353|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and safety of JNJ-54452840 in healthy participants.~   "
95333|NCT01809340|"~     The purpose of this study is to assess whether the antidepressant effect from intravenous~     (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV~     ketamine treatment is stopped.~   "
95334|NCT01809327|"~     The purpose of this study is to assess the effectiveness of the co-administration of~     canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and~     metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite~     treatment with diet and exercise. The safety and tolerability of canagliflozin will also be~     assessed.~   "
95335|NCT01809314|"~     This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon)~     in participants with symptomatic anemia and cancer receiving chemotherapy. Participants~     receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics~     will be followed for 4 months.~   "
95336|NCT01809301|"~     The objective of this study is to compare the absorption of a niacin metabolite~     (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the~     production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be~     used to adjust the top dose of a planned TRIA-622 efficacy study.~   "
95368|NCT01808885|"~     This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group,~     multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when~     administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple~     Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1~     ratio.~   "
95902|NCT01801852|"~     The purpose of this study is to assess the safety and effectiveness of natural killer T~     (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic,~     treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung~     cancer, pancreatic cancer, colon cancer or prostate cancer.~   "
95337|NCT01809288|"~     Background:~      - Rates of diabetes and heart disease in women are increasing. Early recognition of risk~     could help women live longer and healthier lives. Race and ethnicity may affect the best~     kinds of tests to use to screen for these conditions. Researchers want to compare risk~     factors for diabetes and heart disease in African, African-American, and white women. Doing~     so may help identify the most effective screening test for each group. This study will look~     at healthy African, African-American, and white women who are federal employees and~     contractors.~      Objectives:~      - To study risk factors for diabetes and heart disease in African, African-American, and~     white women.~      Eligibility:~        -  Healthy African, African-American, and white women between 30 and 65 years of age who~          are federal employees or contractors.~        -  For this study, African women must be born in Africa and have immigrated to the United~          States, and report that both parents are Africans. African-American women must~          self-identify as African-Americans, born in the United States, and have parents who~          both self-identify as African-American born in the United States. White women must~          self-identify as white and have parents who also self-identify as white.~      Design:~        -  Participants will have four visits to study their risk factors for diabetes and heart~          disease.~        -  The first visit is a screening visit. Participants will be screened with a physical~          exam and medical history. Blood and urine samples will be collected. They will also~          have an EKG test. Participants will also be shown how to fill out a 3-Day Food Record~          and wear an activity monitor called an accelerometer. The food record will keep track~          of how much participants eat for 3 consecutive days, including 1 non-working day. The~          accelerometer device will be worn for 3 days to monitor movement.~        -  At the second visit, participants will have blood tests, an oral glucose tolerance~          test, and body fat measurements. They will also fill out questionnaires, review the~          food record, and have two imaging studies.~        -  At the third visit, participants will have a longer glucose tolerance test. During the~          test, participants will receive both glucose and insulin and blood samples will be~          collected over several hours. Participants will receive lunch at the clinical center~          after the test.~        -  At the fourth visit, participants will have a meal test. They will fast for 12 hours~          before the test. Participants will eat a specific meal and have blood samples taken~          during and after they eat.~        -  Participants will discuss the results of these tests with the study doctors.~   "
95338|NCT01809275|"~     The purpose of this study is to evaluate the safety profile and to obtain an indication as~     to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate~     to severe Crohn's Disease.~   "
95339|NCT01809262|"~     Primary objective: To investigate bronchodilator effect and safety of single doses of BI~     1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics~     of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part~     for additional PK assessments which are not defined as primary or secondary endpoints.~   "
95340|NCT01809249|"~     Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has~     emerged as an option to the traditional deceased-donor transplantation procedure. But there~     is an essential risk related to liver resection for healthy donors.~   "
95341|NCT01809236|"~     This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30~     BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed~     treatment period (3 months) and a PRN period (6 months). In the fixed treatment period~     patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN~     period, patients are monthly visited and retreatment will be needed according to the~     retreatment criteria pre-specified.~   "
95342|NCT01809223|"~     This study is design to evaluate the effect of conbercept therapy on visual acuity and~     anatomic outcomes compared to sham injection and durability of response observed in subjects~     with choroid neovascularization secondary to pathological myopia.~   "
95343|NCT01809210|"~     This is a Phase I, open label multicentre study of selumetinib administered orally in~     combination with first line chemotherapy regimens to patients with advanced/metastatic~     NSCLC. The study has been designed to allow an investigation of the optimal dose of~     selumetinib in combination with various standard first line double-platinum chemotherapy~     regimens. Initial assessment will be based on tolerability of selumetinib in combination~     with one or more selected regimens that are considered to be tolerated also being assessed~     for preliminary evidence of activity.~      This study is a dose finding and optional cohort expansion; In addition all patients will be~     assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.~   "
95344|NCT01809197|"~     The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared~     for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to~     Acuvue® Oasys® lenses cared for with habitual MPDS.~   "
95345|NCT01809184|"~     This trial is conducted in Europe. The aim of this first human dose trial is to investigate~     the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body)~     and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287~     (insulin 287) in a GIPET® I tablet formulation in healthy subjects.~   "
95346|NCT01809171|"~     The third generation oral aromatase inhibitors (AIs) are increasingly being used in the~     management of estrogen receptor positive breast cancer. One of the issues related with~     administration of oral AIs is their side effects, particularly on the musculoskeletal~     system. Although the prevalence and importance of arthralgia and myalgia occurring in BC~     patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these~     invalidating symptoms are unknown.~      In this project, we aim to unravel the interaction between vitamin D and musculoskeletal~     adverse events experienced by AI users. We will also evaluate how vitamin D supplementation~     affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a~     randomized placebo-controlled double blind clinical trial. We will assess changes in the~     musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and~     also monitor serum IGF-I and estrogen levels together with bone resorption and formation~     markers.~   "
95347|NCT01809158|"~     Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom~     dimensions. The negative symptom dimension, with its protean cognitive manifestations,~     responds poorly to treatment, which can be a particular challenge in countries where~     clozapine therapy is not available. Preliminary data indicates that minocycline may be~     beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive~     symptoms. Persons with schizophrenia or schizoaffective disorder and recent onset~     schizophrenic episode or recent relapse who are prescribed minocycline in addition to~     standard antipsychotic medication will show greater symptom reduction, as measured by the~     Positive and Negative Syndrome Scale (PANSS) total score.~   "
95348|NCT01809145|"~     The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to~     metals, in Sarcoidosis patients with occupational exposure.~   "
95349|NCT01809132|"~     This study will compare two different treatments of acute alcoholic hepatitis. The current~     standard of care is treatment with corticosteroids (methylprednisolone). This will be~     compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants~     will be treated and followed for 6 months and the two treatment groups will be compared for~     differences in death rates and laboratory tests that measure liver and gut function.~   "
95928|NCT01801514|"~     The purpose of the study is to evaluate the feasibility of multilayer detection-based dual~     energy computed tomography scanner and to assess the added diagnostic value of dual energy~     applications~   "
95350|NCT01809119|"~     Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm.~     With the evolution of image diagnostic tools and dissemination of its use, smaller tumors~     are being commonly diagnosed and treated. The partial open nephrectomy is still considered~     the gold standard technique for nephron sparing surgery, especially when the surgeon is not~     experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally~     invasive techniques were developed, including the laparoscopic partial nephrectomy. The~     objective of this study is compare the partial laparoscopic nephrectomy to open partial~     nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced~     randomized prospective trial will be conducted. One group of patients will be submitted to~     to open partial nephrectomy while the other group of patients will be submitted to~     laparoscopic partial nephrectomy. A randomized prospective trial comparing the two~     techniques is necessary to determine the differences in outcomes between them and if the~     laparoscopic partial nephrectomy can be performed without harms to the patients.~   "
95351|NCT01809106|"~     Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life~     of patients and a high incidence, with values around 70-90% in advanced and metastatic~     stages. Than 20 years the main reference for the pharmacological treatment of cancer pain~     are the guidelines produced by the World Health Organization (WHO). This document shows that~     the use of opioid drugs is the mainstay of treatment, with particular reference to opioids~     major (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in~     Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the~     data currently available, have an analgesic effect would partly overlap but with different~     percentages of non-responders (NR), a different need to increase the dose over time to~     maintain adequate analgesia, a different action to the switch to another molecule for~     ineffectiveness analgesic. The observations described suggest that opioids, although they~     belong to the same family drug may not be fully comparable with regard to the clinical~     effects products. Important differences are known on the pharmacokinetic and pharmacodynamic~     and, more recently, also in terms of pharmacogenomics. This is a comparative study of~     analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible~     differences in terms of analgesic efficacy, changes in dose over time, use of switch or~     permanent abandonment of treatment, parallel to the contour of the side effects. The~     associated sub-project will link the structure gene of patients and clinical results have~     emerged.~   "
95352|NCT01809093|"~     You are being asked to be in a research study to determine blood levels and vitreous levels~     of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF).~     These compounds exists naturally in your body.~   "
95353|NCT01809080|"~     Retrospective studies have established a strong correlation between reports of life stress~     and depression. Investigators have begun to further explore this relationship by examining~     the role of gene x stress interactions in the pathogenesis of depression. In a recent~     landmark study, Caspi and colleagues (2003) reported an interaction between a serotonin~     transporter promoter polymorphism and life stress in the development of depression. This~     finding has been replicated in some but not all follow up studies. Despite the initial~     promise of these results, the ability to draw definitive conclusions is compromised by~     significant study design limitations: 1) retrospective design 2) a focus on acute rather~     than chronic stress 3) substantial variation in the character and intensity of stress~     between subjects. Medical internship is a period filled with predictable and high levels of~     chronic uncontrolled stress. Rates of depression among interns are elevated compared to the~     general population. In this study, we aim to utilize the predictable and consistent stress~     of internship to investigate the relationship between stress, genes and depression with a~     prospective study design that bypasses some of the pitfalls of previous studies.~   "
95354|NCT01809067|"~     Research Question:~      What effect if any does the use of lavender aromatherapy have on a patient's stress and~     anxiety during the MRI procedure in the Cardiovascular Services Department?~      Hypothesis:~        1. The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.~        2. MRI cancellations related to stress and anxiety will decrease by 10%.~      Sample size of 30 patients is needed for the control group and the lavender aromatherapy~     group, for a total of 60 patients.~      Rationale:~      Patients undergoing MRI procedures may experience stress and anxiety related to the small~     and confining space required during the scan. Anyone with a history of claustrophobia, panic~     attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or~     anxiety during the MRI procedure (Harris, Cumming, & Menzies, 2004, p. 1). This stress and~     anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the~     patient's nervous tremors or involuntary quivering may adversely affect the images obtained.~     Lavender aromatherapy has been shown to reduce stress and anxiety for patients in other~     settings; however, its use during MRI procedures has not been studied.~      This project investigates the use of lavender aromatherapy as a non-pharmacological way to~     help patients relax during their MRI procedure. Lavender aromatherapy has been studied and~     shown to reduce stress and anxiety for patients in other situations, but it has not been~     studied during MRI procedures. Lavender is known to be uplifting, as well as soothing and~     helpful for reducing stress, anxiety, depression, and insomnia (Herz, 2007, p. 264). If~     aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction~     with their MRI procedure will increase and the need for sedating medication could decrease.~   "
95355|NCT01809054|"~     This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to~     detect changes in coagulability following elective total knee and hip arthroplasty. Patients~     will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:~        1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325~          mg for 5 weeks, or~        2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc.,~          Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~   "
95356|NCT01809041|"~     Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon.~     Most patients will receive general anesthesia during surgery. Two groups of general~     anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not~     different in patients received intravenous anesthetics only or sevoflurane (a volatile~     anesthetic-based general anesthesia for their major intra-abdominal surgery.~   "
95357|NCT01809028|"~     This study will test the amount of tissue, called cell block, obtained from your pancreas.~     Patients who are asked to participate in this study have a growth (mass) in the pancreas~     that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes~     (number of times the doctor biopsies the mass), at this time we do not know the ideal number~     of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of~     this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.~   "
95929|NCT01801501|"~     The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth~     Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.~   "
95358|NCT01809015|"~     Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established~     therapy for both prevention and treatment of thromboembolism in daily clinical routine.~     Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an~     increasing complexity of medical therapy. However, data on quality and management of VKA~     therapy with phenprocoumon in current medical care are limited. Our aim was to investigate~     the quality of OAC with VKA in current health care and to evaluate the potential for~     improvements.~      The investigator-initiated thrombEVAL study program comprises two cohorts of patients~     treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a~     multicentre cohort of patients in regular medical care and a multi-local, single centre~     cohort of patients in a telemedicine-based coagulation service. The study program is~     expected to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts~     build on a detailed clinical assessment of participants and anticoagulation therapy at study~     enrolment. Subsequently active and passive follow-up investigations are carried out to~     document and validate complications of the treatment. Primary short-term outcome is the~     distribution of time in therapeutic range; the primary long-term outcome comprises the~     composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant~     bleeding and death.~   "
95359|NCT01809002|"~     Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and~     functional outcomes for the repair of nerve injuries in the hand.~   "
95360|NCT01808989|"~     The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at~     the buttocks and chest level during walking. Before and after exercise the diagnosis,~     investigations and treatments ongoing or to be performed are recorded.~      The present study focuses on the clinical interest of the transcutaneous oxygen pressure~     during exercise in the diagnosis of claudication in patient referred for an oximetry~     exercise test.~   "
95361|NCT01808976|"~     Over two million people in the US download health apps onto their smartphones and tablets,~     with the intent of improving their quality of life. Despite widespread use of these apps,~     there is relatively little information regarding app user access (do users download health~     apps and use them more than once), app user engagement (do users follow the app protocols)~     and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a~     future randomized controlled trial investigating access, engagement and impact of two types~     of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem~     Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a~     cognitive training game called Evolution) and compare both to an information only app. Our~     intent is to conduct this study entirely on mobile devices, in order to investigate access,~     engagement, and impact in an ecologically valid manner. The purpose of this pilot study is~     to test the feasibility of conducting our future randomized controlled trial comparing three~     mobile mental health apps for the management of depressed mood, improvement of cognitive~     control, and improvement in activities of daily living in people aged 18 and older.~     Recruitment, consent, randomization, app use and outcome assessment will be conducted~     entirely on mobile devices. We will recruit 150 people through four different recruitment~     avenues to determine which avenue results in the most representative sample of our target~     population (people 18 and older who have symptoms of depression that are interfering with~     their quality of life). We will also determine the number we need to recruit to have a final~     sample of 150 people willing to be randomized between the 3 apps and complete an 12-week~     study of app impact on mood, cognition and function. This pilot will provide information on~     the completeness of data from a study conducted in this manner, and uncover any other~     challenges we may face by using mobile devices for data collection, and if we will find~     differential drop out between app type (e.g.: will more people stop using of the information~     only app prematurely?). Although we will not have sufficient statistical power to answer~     questions about comparative effectiveness between the apps, we plan to explore relationships~     between sample demographics, app use, and improvement in cognitive control on improvements~     in mood and function.~   "
95362|NCT01808963|"~     To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.~   "
95363|NCT01808950|"~     The primary objective is the observation and description of the preliminary efficacy of~     resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of~     patients.~   "
95364|NCT01808937|"~     The Morphea in Adults and Children (MAC) cohort is the first registry for both children and~     adults with morphea (also known as localized scleroderma) in the country. The purpose of the~     registry is to learn more about morphea, specifically:~        -  How morphea behaves over time~        -  How frequently specific problems occur along with morphea (for example, arthritis)~        -  Whether morphea has an autoimmune background~   "
95365|NCT01808924|"~     The overall objective of this project is to thoroughly investigate the effects of~     diet-induced weight loss in the absence of or in combination with exercise on skeletal~     muscle IR, energy metabolism and function. These studies will significantly improve our~     understanding of the fundamental biochemical and molecular factors linking~     intervention-induced changes in mitochondria, oxidative stress, lipotoxicity, IR, and loss~     of muscle function in aging humans.~   "
95366|NCT01808911|"~     CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid~     combined with rituximab in patients with acquired haemophilia. The study will test the~     hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus~     rituximab for FVIII inhibitor eradication in acquired haemophilia.~   "
95367|NCT01808898|"~     The usual intervention to control the pain during an outpatient endometrial ablation has~     been to use local anaesthesia (LA) injection just in the neck of the womb (cervix). However,~     this alone may not be sufficient to control the pain completely. Therefore, we want to find~     out whether an injection of LA given deep into the muscle of the womb (myometrium), in~     addition to that in the cervix, has a better effect on controlling the pain during the~     procedure.~      All women attending gynaecology outpatient clinics, who have consented for an outpatient~     hysteroscopic procedure, will be invited to take part in the study. The study will be~     carried out in the outpatient hysteroscopy clinic at Birmingham Women's Hospital.~      As part of standard pain control method during an outpatient endometrial ablation, all women~     will receive an injection of LA in the cervix of the uterus to 'freeze it'. During~     hysteroscopy a randomly selected treatment group will receive an injection into deep muscle~     containing only normal saline (control group) whereas the experiment group will receive fast~     / long acting local anaesthesia (cornual block).~      Women will be asked to rate the degree of pain by placing a mark on an ungraduated 10 cm~     horizontal line. These scales will be given before the procedure, during LA injection,~     immediately after, one hour and at the time of discharge from hospital.~      The results will help future patients undergoing a similar procedure to have much better~     pain relief and allow many more to have the procedure without the side effects of a general~     anaesthetic and its risks. In addition to having less pain, it may reduce the number of~     painkillers needed as well as any stay in hospital. In future this may also allow a greater~     variety of procedures to be done in an outpatient setting.~   "
96021|NCT01800279|"~     The purpose of this study is to determine whether kinesitherapy techniques and a myofascial~     therapy protocol are effective in the treatment of temporomandibular joint dysfunction in~     patients with fibromyalgia syndrome.~   "
95369|NCT01808872|"~     The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic~     peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis~     and assessment of the severity of heart failure in point-of-care and laboratory settings.~     The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and~     NT-proBNP assays for both whole blood and plasma in the intended use population.~   "
95370|NCT01808859|"~     The purpose for this study is to investigate the quadriceps (thigh) function preoperatively~     and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint)~     in a randomised study with or without the use of a Tourniquet (cuff around the thigh during~     surgery) (100 mm Hg > systolic blood pressure).~   "
95371|NCT01808846|"~     To explore whether obese adolescents with insulin resistance and relative low leptin levels~     exhibit functional alterations of the neuronal circuits involved in the regulation of energy~     metabolism and food seeking behaviors.~      We here propose to test the hypothesis that the reward circuitry is dysregulated in obese~     adolescents and is related to the degree of insulin resistance and hyperinsulinemia.~   "
95372|NCT01808833|"~     The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and~     radiation therapy in the elderly will predict treatment-related toxicity and morbidity and~     that such assessment at serial time points will help improve treatment and outcomes for~     these patients.~   "
95373|NCT01808820|"~     Dendritic Cell vaccine manufactured and partially matured using our standard operating~     procedures, developed in collaboration with the HGG Immuno Group, then administered through~     imiquimod treated skin will be safe and feasible in patients with high grade glioma. This~     will result in anti-tumor immunity that will prolong survival of subjects treated. Study~     treatment will correlate with laboratory evidence of immune activation.~   "
95374|NCT01808807|"~     To elucidate the audit's effect on caesarean section rate, and also define the factors~     influencing the caesarean section rate.~      From Jan 2007 , pregnant women who delivered in a medical center will be included~     retrospectively in this study. Our monthly cesarean section audit, focusing on discussing~     the indications of cesarean section, began from July 2008. Clinical data, indications of~     cesarean section, and perinatal outcomes were compared between the cases of before and after~     the audit. Multivariate logistic regression was performed to identify factors affecting~     cesarean section rate.~   "
95375|NCT01808794|"~     The purpose of the study is to compare one material called Mucograft with another material~     called Dynamatrix. These materials are used as a type of a barrier (made from pig material~     also known as porcine material) in a preservation technique to increase the thickness and~     width of tissues at a tooth extraction site. The investigators want to see if one works~     better than the other or if they work equally as well. These materials are made up of~     collagens, which are naturally occurring proteins found in the skin, specifically connective~     tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of~     fewer collagens. These materials have been given something called a 510(k) status by the~     FDA. This means that the FDA determines them to be equivalent to another product that they~     have previously approved. You will be put into one of two groups at random, and will not~     know which one you are in. Like flipping a coin, you will have a 50/50 chance to be in~     either one of the two groups. You will either be in a group using Mucograft or in a group~     using Dynamatrix. Both of these materials are regularly used in the dental clinics.~   "
95376|NCT01808781|"~     The purpose of this study will be to find out the effect of two different interventions on~     muscle strength, ability to produce muscle force quickly (power), daily function, and number~     of steps and physical activity an individual with total knee replacement do daily.~      The research hypotheses for this study will be as follows:~        -  For individuals who are at least 6 months post-total knee replacement, home-based~          high-velocity training exercises will result in significantly greater improvements in~          muscle strength and power compared to those who receive a walking program only.~        -  For individuals who are at least 6 months post-total knee replacement, home based~          high-velocity training exercises will result in significantly greater improvements of~          daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking~          program only.~        -  For individuals who are at least 6 months post-total knee replacement, home based~          high-velocity training exercises will result in significantly greater improvements in~          physical activity behavior (eg. number of steps per day)compared to those who receive a~          walking program only.~   "
95377|NCT01808768|"~     To study the impact of alcaftadine in patients treated with other opthalmic ocular agents~     (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.~   "
95378|NCT01808755|"~     Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic~     regimes do not change the long term risk of recurrence.~      Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to~     evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.~      Design, setting and participants- : In this crossover trial female patient were eligible for~     the study if they had recurrent UTIs, that is three ore more episodes during the preceding~     12 months. Suitable patients were randomly assigned to antibiotic treatment with~     trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received~     the other intervention in the second phase of the study.~      Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain~     (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at~     the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as~     mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for~     paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and~     number of voidings between treatment. Data analysis was performed with STATA statistical~     package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).~   "
95407|NCT01808313|"~     This open label, single-arm, non-controlled, multicentre study will determine the effect of~     ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of~     a screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week~     dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for~     12 weeks (PEP).~   "
95408|NCT01808300|"~     A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing~     clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and~     Thioctic acid after oral administration in healthy male volunteers.~   "
95379|NCT01808742|"~     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive~     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience~     Cryo-Touch III device uses well-established principles of cryobiology to cause localized~     reduction in muscle activity resulting in a reversible reduction in facial animation and the~     appearance of facial lines. The device operates on well-established cryobiology principles;~     that localized exposure to controlled low temperature conditions can alter tissue function.~     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form~     of an assembly of small diameter needles, creating a highly localized treatment zone around~     the probe. The thermal algorithm is designed to produce a reversible loss of nerve~     conduction resulting in a temporary decrease in muscle contractility. Prior studies of~     Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness~     and safety for applications in this indication. The goal of the study described herein is to~     investigate optimized algorithms and ongoing safety and effectiveness.~   "
95380|NCT01808729|"~     The purpose of this project is to see if heritable alterations in the function, biology and~     vascular repair capacity of vascular cells make a major contribution to the burden of~     coronary artery disease (CAD), fibromuscular dysplasia (FMD), and other vascular diseases.~      In more detail, FMD is a nonatherosclerotic vascular disease that primarily affects women~     aged 20 to 60. It commonly affects the renal and carotid arteries but may involve almost~     every artery in the body. At the cellular level, FMD is characterized by increased~     fibroblast proliferation and collagen deposition. This study aims to define some of these~     cellular problems by directly studying fibroblast cells from FMD patients and healthy~     control subjects. Similarly, CAD is among the leading causes of death worldwide. However, a~     large part of the risk for CAD is unexplained. It is thought that a major but undefined risk~     factor may be gene (genomic) variations causing a change in vascular cell function. Here, we~     will study important vascular cell types in patients with severe and early onset CAD in an~     attempt to define these problems. Therefore, in summary, this study will look to define the~     various cellular-level problems that occur in patients with both in CAD and FMD. These data~     will be linked to DNA-level analyses to ultimately attempt to define the cause of these~     conditions.~   "
95381|NCT01808716|"~     The study hypothesis is a decreased muscle damage induced by exercises when low-level laser~     therapy is applied on body muscles before exercises.~   "
95382|NCT01808703|"~     The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch)~     applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs~     of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone.~     Eighty patients with advanced gum disease will be recruited and treated within this clinical~     trial. Patients will be evaluated for changes in gum measurements over a 12-week period.~   "
95383|NCT01808690|"~     Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D)~     cause early heart disease, shortening lifespan despite modern improvements in control of~     blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known~     as insulin resistance (IR), is the main factor causing heart disease in type 2 diabetes~     (T2D), but the cause of increased heart disease in T1D is unclear. IR may contribute to~     heart disease in T1D as in T2D, as the investigators and others have found the presence of~     IR in T1D. Much less is known about IR in T1D, but a better understanding of its role in T1D~     is critical to understanding causes of heart disease in T1D. The investigators long-term~     goal is to understand the early causes of heart disease in diabetes so that we can prevent~     it. The investigators unique initial findings suggest that even reasonably well-controlled,~     normal weight, T1D youth are IR. The IR appears directly related to the heart, blood vessel,~     and exercise defects, but in a pattern that appears very different from T2D. The goals of~     this study are to determine the unique heart, blood vessel and insulin sensitivity~     abnormalities in T1D youth, and determine whether metformin improves these abnormalities. A~     clear understanding of these factors will help determine the causes, and what treatments~     could help each abnormality.~      Hypothesis 1: Metformin will improve insulin function and mitochondrial function in T1D.~      Hypothesis 2: Metformin will improve vascular and cardiac function in T1D.~      All measures will be performed twice, before and after a 3-month randomized,~     placebo-controlled design where subjects are randomized to either metformin or placebo. The~     independent impact of insulin action as well as glucose levels, BMI, T1D duration, and~     gender on baseline outcomes and the impact of changes in insulin action, glucose levels and~     BMI on response to metformin will also be examined to help customize future strategies to~     prevent heart disease in T1D. This study will advance the field by providing new information~     about the role of poor insulin action in the heart disease of T1D, and whether improving~     insulin action in T1D is helpful. If a focus on directly improving insulin action in T1D~     youth is supported by our studies, the clinical approach to T1D management may significantly~     change.~   "
95384|NCT01808677|"~     The goal of this research study is to learn more about the safety of treating NSCLC with~     reirradiation using standard methods and to look for ways to lessen side effects and improve~     therapy. Reirradiation is when radiation is given to an area of the body that has previously~     received a full dose of radiation.~   "
95385|NCT01808664|"~     In this study, the investigators will develop and evaluate a novel intervention using~     standardized patients (SPs) -- or actors playing the roles of patients -- to enhance~     physicians' patient-centered counseling skills regarding two frequently overused,~     potentially inappropriate services in primary care: magnetic resonance imaging (MRI) for~     acute low back pain and bone densitometry in women at low-risk for osteoporosis. The~     investigators will further evaluate whether intervention effects on physician~     patient-centeredness generalize to counseling regarding other costly, unnecessary diagnostic~     tests.~   "
95386|NCT01808651|"~     This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the~     treatment of MDD in adult Japanese participants.~      Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#:~     NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for~     an additional 52 weeks.~   "
95387|NCT01808638|"~     The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic~     cancer disease by combining the new investigational medicinal product Atu027 with the~     standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s~     anti-tumor activity with Atu027.~      The objectives of this clinical trial are to evaluate safety and activity of two Atu027~     schedules in combination with standard gemcitabine treatment in patients with advanced or~     metastatic pancreatic adenocarcinoma.~   "
95409|NCT01808287|"~     The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3~     Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems~     in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve~     replacement.~   "
95410|NCT01808274|"~     The purpose of this study is to assess the safety and device success of the Edwards CENTERA~     Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis~     who are indicated for aortic valve replacement.~   "
95411|NCT01808261|"~     Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.~   "
95388|NCT01808625|"~     Radiotherapy is the mainstay of treatment for brain malignancies and is associated with~     significant neurotoxicity. Due to continuous increase in patient's survival, the long term~     risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive~     impairments are increasing concerns. Currently there is no effective treatment for~     preventing long term radiation-induced brain damage.~      Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within~     a pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen~     stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft~     tissues and bone due to its ability to stimulate healing processes by supplying the~     energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen~     stimulation by HBOT is currently indicated for patients with overt radiation-induced~     neurotoxicity and was proven to reduce further development of radiation damage while~     stimulating idling neurons to return to function. Since HBOT is considered safe, we~     hypothesize that its application following radiation, before the manifestation of~     neurological side effects, may help avert development of early/delayed onset~     radiation-induced neurotoxicity.~      In the proposed study, for the first time, HBOT will be applied early after radiation to~     prevent the expected decrease in patients neurocognitive functions (NCF) and improve their~     quality of life (QOL). The study is designed to provide statistically significant~     assessment, in a prospective randomized clinical trial, of the effect of oxygen stimulation~     applied soon after brain radiotherapy, for patients with primary and secondary brain tumors,~     on patients QOL and NCF. In addition, advanced imaging methodologies will be applied to~     study the feasibility of quantifying oxygen stimulation effects on the tumor and surrounding~     brain tissue.~   "
95389|NCT01808612|"~     The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in~     Japanese adult participants with Major Depressive Disorder (MDD).~   "
95390|NCT01808599|"~     Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab~     followed by maintenance therapy with subcutaneous Rituximab in patients with histologically~     proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any~     extranodal site, either de novo, or relapsed following local therapy (including surgery,~     radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).~   "
95391|NCT01808586|"~     A) Background Chronic neck pain is a significant and common issue which is difficult to~     treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they~     are sometimes injected to manage chronic neck pain. However, these injections seldom lead to~     significant, long-lasting relief. In some cases, these trigger points may originate from~     injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint~     with cortisone injection may lead to improved pain relief and function.~      B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight~     bands of muscle in the neck and shoulders will be relieved to a greater extent than that~     attained through trigger point injection.~      C) Methods Patients with neck pain will have a test to determine if any pain originates from~     the facet joint. Among those who have significant pain from these joints, a comparison~     between the effect of cortisone injection into these joints versus injection into the~     trigger points will be evaluated.~      D) Expected Results and Significance~      It is expected that injection with cortisone into the facet joints will lead to improved~     pain and function when compared to that attained from trigger point injection. In addition,~     the number of trigger points, and the pain and headache that originate from these trigger~     points, are expected to decrease with cortisone injection into the facets to a statistically~     and clinically significant extent. Results from this pilot study will then influence the~     design of future trials into chronic neck pain treatment, leading to better clinical~     recommendations. A peer-reviewed publication and conference presentations will facilitate~     dissemination.~   "
95392|NCT01808573|"~     This is a randomized, multi-center, multinational, open-label, active-controlled, parallel~     design study of the combination of neratinib plus capecitabine versus the combination of~     lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2~     directed regimens in the metastatic setting.~   "
95393|NCT01808560|"~     The purpose of this pilot feasibility study is to assess whether treating meibomian gland~     dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual~     quality and ocular comfort after cataract surgery.~   "
95394|NCT01808547|"~     The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of~     topical administration of ISV-303 compared with Durasite Vehicle.~   "
95395|NCT01808534|"~     This phase II trial studies how well palifosfamide works in treating patients with recurrent~     germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing~   "
95396|NCT01808521|"~     In this study, the investigators want to determine if N-acetylcysteine(NAC), given~     intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia~     Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The~     investigators want to determine, through anti-oxidant activity, if NAC will have additional~     efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing~     propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in~     the patient's platelet count, decrease in number of days requiring TPE, and decrease in~     microvascular thrombotic complications. The investigators will additionally: 1) Assess~     safety of NAC by evaluating subjects for adverse events and significant adverse events 2)~     Determine effects on TTP by measuring clinical and research laboratory values 3) Determine~     drug effects by measuring clinical and research laboratory values.~   "
95397|NCT01808508|"~     Many individuals with Down syndrome (DS) have breathing problems during sleep. This is~     called obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down~     syndrome because of the shape of their face and tongue and because of their low muscle tone.~     OSAS can cause a lot of health problems including behavioral and learning problems as well~     as heart problems.~      The purpose of this research study is to look at the effects of treating OSAS in individuals~     with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The~     investigators want to see if treatment of OSAS improves learning, behavior and heart~     problems.~   "
95398|NCT01808495|"~     The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human~     Corneal Fibroblasts under treatment of mitomycin C (MMC).~   "
95412|NCT01808248|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir~     (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for~     12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who~     have previously failed prior treatment with an interferon-based regimen.~   "
95413|NCT01808235|"~     The purpose of this study is to pilot test an intervention to improve oral health for~     individuals with memory problems. The results from this study will assist in developing~     prevention and intervention programs aimed at maintaining good oral health, or at least~     slowing its deterioration.~   "
95399|NCT01808482|"~     This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will~     enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single~     ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of~     GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity,~     paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers~     of Th1 and Th17 mechanisms.~      Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of~     the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will~     be randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in~     each dosing session they will receive study treatment in a 3:1 ratio of active: placebo~     respectively.~      Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor~     occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio~     to A or P. Each subject will receive the same study treatment for repeated doses. If the~     duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12~     subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part~     C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses.~      Safety/tolerability and PK data monitoring and the decision to proceed to the next dose~     level of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be~     made by a dose escalation committee.~   "
95400|NCT01808469|"~     The purpose of this study is to determine the safety, tolerability and distribution and~     elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition~     its effects on some inflammatory parameters will be measured in presence or absence of~     lipopolysaccharide stimulation.~   "
95401|NCT01808456|"~     Influenza infection in recipients of solid organ transplants recipients while on maintenance~     immunosuppressant therapy is associated with increased morbidity and mortality. Although~     influenza vaccination is recommended in these high-risk patients, safety and immunogenicity~     of commercially available different strengths of influenza vaccine have not been~     established.~      The primary study objective is to determine the safety and immunogenicity of Fluzone and~     Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of~     two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are~     commercially available for use in the general population. Fluzone is approved for use in 6~     months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and~     older.~      This is an exploratory, open-label, parallel group, observer blinded, prospective study. All~     recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at~     least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be~     eligible for enrollment.~      Enrolled patients will be followed for three months (a total of 4 visits) following~     enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and~     12.~   "
95402|NCT01808443|"~     The purpose of this study is to test the efficacy of laser versus cryotherapy on the~     treatment of warts~   "
95403|NCT01808430|"~     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery~     (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH®~     Staplers 45 mm and/or 60 mm (study devices).~   "
95404|NCT01808417|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the~     feasibility and safety of an investigational technique or drug. This study will try to~     define an appropriate dose of the investigational drug indocyanine green (ICG) in~     combination with near infrared (NIR) imaging to use for further studies. Investigational~     means that this drug, ICG, is approved by the FDA for other imaging uses, but not for~     lymphatic mapping using NIR light. Its use for following lymphatic pathways from tumors in~     the human body is still being studied and research doctors are trying to find out more about~     it. It also means that the FDA has not approved ICG mapping for your type of cancer.~      ICG is a dye and is approved for testing liver function and measuring blood flow from the~     heart. This drug has been used in studies to map lymphatic pathways in lung cancer and~     breast cancer and information from those other research studies suggests that this dye may~     help to identify lymph nodes associated with your esophageal tumor in this research study.~     ICG can be detected within the body using special near-infrared light cameras. In this~     research study, the investigators are looking at how easily ICG can get to the first lymph~     node (called the sentinel lymph node or SLN) associated with your esophageal tumor and~     whether the investigators can see the path of the ICG and the respective SLN using a near~     infrared camera.~   "
95405|NCT01808404|"~     College counseling centers (CCCs) are being faced with increasing demands for services to~     meet the treatment needs of their students, in the context of increasingly severe cases and~     declining resources. Innovative, cost effective solutions are needed.~      The proposed project seeks to meet these needs by testing a web-based guided self-help~     version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic~     therapy found to effectively treat a range of psychological problems. An ACT program would~     provide a means of implementing effective treatment for the range of problems in the CCC~     setting, while the guided self-help format would reduce counselors' workload, improving~     cost-effectiveness and reducing waiting lists. This would both treat students and train~     counselors in how to implement the ACT intervention. Three self-help lessons have been~     developed, as well as a counselor portal to review students' use of the program and to~     receive training on implementing ACT guided self-help.~      The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and~     60 clients from multiple CCCs throughout the country.~   "
95406|NCT01808391|"~     This is a prospective, multicenter, historical controlled study. The present clinical study~     will measure non-inferiority of 12 month TLF rate compared to historical control.The~     selected historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that~     study is a prospective, multicenter, randomized, two-arm, international, open-label~     study.The historical control did not have angiographic follow up before 12 months, in the~     present clinical study, only subjects with clinical follow-up conducted at 12 months without~     any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part~     of this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up~     cohort) will be included in this analysis cohort.~   "
95414|NCT01808222|"~     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases~     diagnosed per year. Several different local therapies are available for treatment; including~     surgery and radiotherapy Significant advances have been made which have improved the cancer~     control outcomes and treatment. Despite these significant advances, approximately 30% of~     patients treated with definitive local therapy experience recurrent disease. Recurrent~     (returning) disease usually displays rising PSA (blood test for prostate cancer). The PSA~     level is often of limited use in differentiating local recurrence (i.e. recurrence in the~     prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence).~     Imaging plays a central role in the detection of recurrent prostate carcinoma in the~     prostate bed and in the differentiation of prostatic from extraprostatic recurrence. There~     are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission~     tomography (PET) with molecular radiotracers that are currently under study for the imaging~     of post-therapy recurrence.~      One PET radiotracer which has shown promise in the staging and restaging of patients with~     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid~     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher~     accuracy compared with other methods in the restaging of patients with suspected recurrent~     prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory~     system including 128 subjects with prostate cancer.~      The investigators will perform a study with 25 patients in whom the investigators have a~     strong suspicion of prostate cancer that has returned to the body after having an initial~     treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and~     MRI imaging individually then together will be useful in the detection of local and~     extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of~     the FACBC scan and one week later as required by the FDA.~      All patients will undergo biopsy of the prostate as clinically appropriate per standard of~     care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer~     site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence~     sites will be scheduled at the subjects' convenience as soon as possible after the scans.~      Tissue obtained from the biopsy will undergo standard analysis to determine if prostate~     carcinoma cells are present. The secondary goal will be to use left-over biopsy material to~     determine if there are genotypic differences between prostate carcinoma recurrence confined~     to the prostate bed and extraprostatic recurrence~   "
95415|NCT01808209|"~     Clinical Performance of Stenfilcon vs. Filcon II 3~   "
95416|NCT01808196|"~     The purpose of this research study is to test the safety of losartan potassium and see what~     effects (good and bad) it has on you and your eosinophilic esophagitis.~   "
95417|NCT01808183|"~     The purpose of this study is to use a device to compare the blood flow in the patient's~     injured arm to the patient's uninjured arm. This will help us determine 'normal' readings~     for this device for a child's forearm and may in the future help us detect children that~     have injured the blood vessels that go to the forearm when they have an elbow fracture. The~     patient will be one of approximately 100 people involved in this research project at~     Carolinas Medical Center, and the patient's participation will last until the patient is~     discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the~     readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is~     also hypothesized that if the blood vessel of the injured arm is injured, the readings on~     the NIRS device will be different than on the uninjured arm.~   "
95418|NCT01808170|"~     The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy~     versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti~     mullerian hormone and antral follicle count in patients with endometriomas.~   "
95419|NCT01808157|"~     This is a Phase II, multi-centre, randomised, double-blind, placebo-controlled study in male~     and female subjects, aged ≥ 12 years with mild/moderate atopic dermatitis and at least~     moderate pruritus. All subjects will receive BID topical applications of CT327 ointment or~     vehicle for up to 4 weeks.~      At baseline, the subjects must have atopic dermatitis, as defined by the Hanifin and Rajka~     criteria, which involves a minimum of 5% and a maximum of 20% body surface area, an~     Investigator Global Assessment Score of 2 or 3 (mild or moderate) and pruritus visual~     analogue scale scores of ≥ 40mm (at least moderate).~      All subjects will attend a screening visit not more than 21 days prior to Day 1. Subjects~     will be required to return to the clinic on Days 1 (baseline visit), 4, 11, 18 and 29 (end~     of treatment visit). All subjects will be asked to attend for a follow-up visit 14 (±3) days~     after the last dose of study medication.~   "
95420|NCT01808144|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad in~     combination with febuxostat over a long-term timeframe.~   "
95421|NCT01808131|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad in~     combination with allopurinol over a long-term timeframe.~   "
95422|NCT01808118|"~     This is a Multicenter, randomized, double-blind study in subjects with moderate to severe~     non-radiographic Axial Spondyloarthritis.~      There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled~     period for subjects who meet the randomization criteria. Subjects who flare during the~     double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.~   "
95423|NCT01808105|"~     To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a~     commercial infant formula and human breast milk.~   "
95424|NCT01808092|"~     The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to~     Meropenem for treating hospitalized adults with nosocomial pneumonia including~     ventilator-associated pneumonia~   "
95425|NCT01808079|"~     This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding~     genetic markers for Wilms tumor may help identify patients who are at risk of relapse.~   "
95426|NCT01808066|"~     The purpose of this study is to examine the use of, and reaction to, one particular software~     application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The~     hypothesis is that the use of these devices will increase engagement, motivation, interest,~     and have perceived benefits to users with unique attention-limiting cognitive disabilities.~     How does the observation of and user feedback from gameplay reveal areas of improvement for~     the game, strengths, and perceptions of value among the players and adults?~   "
95427|NCT01808053|"~     To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart~     rate (HR), activity and breathing data, which will be integrated with weight, blood pressure~     and symptom data, in subjects in an independent living center, with wireless transmission of~     data to a central data analysis hub.~   "
95438|NCT01807910|"~     The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER)~     stress in the liver is associated with significant alterations in phosphatidylcholines that~     drive the NASH phenotype in obese humans. The investigators plan to examine this hypothesis~     in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery.~     Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or~     glucose feeding to determine the biosynthesis and kinetics of secretory lipoprotein~     phospholipids. It is proposed that phospholipid metabolism play an important role in the~     pathogenesis or etiology of fatty liver in non-alcoholic conditions through mechanisms that~     invoke ER and oxidative stress responses.~   "
95428|NCT01808040|"~     In this study the investigators want to find out about the effects of this drug in women~     with metastatic breast cancer. The study has two major parts; dose escalation and dose~     expansion. In the first part or dose escalation, subjects will be treated at the lowest dose~     effective in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the~     highest dose tolerated in men: 400 mg two times daily. This part of the study is designed to~     see if female subjects can safely tolerate orteronel (TAK-700), and to measure the changes~     in estrogens and androgens at different levels of TAK-700.~      In the second part of the study (dose expansion), seven women will be treated with the dose~     identified in the first part of the study as being safest and most effective. In this part~     of the study, the investigators want to see if orteronel (TAK-700) will routinely and~     significantly decrease the estrogen levels at the dose which will be used for any future~     studies.~   "
95429|NCT01808027|"~     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in~     England and develop recommendations for improving patient care.~   "
95430|NCT01808014|"~     Posterior lumbar spinal surgical pain leads to a severe degree of pain, and, hence, various~     means of pain management are required. Opioid pain medications such as morphine and fentanyl~     are frequently used as intravenously administered medications. To reduce the use of opioids~     for pain relief, a non-opioid form of pain relief, such as a Non-Steroidal Anti-Inflammatory~     Drug (NSAID), is often added to the regimen.~      With the use of NSAIDs, however, the risk of systemic side effects such as bleeding,~     gastroduodenal bleeding, and kidney damage are being reported, and there is also a report of~     inhibition of spinal fusion; these risks limit the use of NSAIDs.~      Nefopam, a new centrally-acting analgesic agent, has been reported in an animal study to~     desensitize post-surgical pain, and when used with an opioid analgesic, it indirectly~     controlled the NMDA receptor, which inhibited the generation of c-fos gene at the spine.~     There are also reports that Nefopam managed pain by inhibiting the serotonin reuptake~     receptors.~      In clinical practice, the administration of Nefopam in patients who required post-surgical~     pain management reduced the use of opioid analgesics by 20-50 % and also reduced the~     prevalence of nausea and vomiting.~      Therefore, the investigators considered whether the addition of Nefopam for intravenous~     patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side~     effects seen in monotherapy with opioid analgesia and result in effective pain management.~     This study was conducted to address this question.~   "
95431|NCT01808001|"~     This study will determine if operating room teams manage a simulated event more effectively~     using a critical event checklist. Performance will be evaluated using a score based on how~     closely they follow a protocol for critical event management; a 'team' score and a score~     based on clinical recovery of the simulated patient. All teams will receive a debriefing~     session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a~     period of 6-9 months.~      The investigators will be testing the hypothesis that both clinical and behavioral team~     performance will improve with the use of Critical Event Checklists. The investigators also~     expect that health professional (participant) could attain knowledge related to the~     importance of non-technical skills and the use of CECs in the management of critical events.~   "
95432|NCT01807988|"~     The main purpose of the study is to test whether Internet-based relapse prevention plus~     medication has a better protective effect compared to medication only, for persons with~     residual depressive symptoms who are currently in paid employment or in education. We~     hypothesise that during the two years following the intervention:~        -  The persons in the group receiving Internet-based relapse prevention plus medication~          will be absent from work for fewer days due to sick-leave compared to those in the~          medication-only group.~        -  Fewer persons in the group receiving Internet-based relapse prevention + medication~          will experience long term sick-leave (60 days or more) compared to those in the~          medication-only group.~        -  The persons in the group receiving Internet-based relapse prevention plus medication~          will suffer fewer depressive relapses compared to those in the medication-only group.~        -  At follow-up, the persons in the group receiving Internet-based relapse prevention plus~          medication will have higher health related quality of life and lower levels of~          depressive symptoms compared to those in the medication-only group.~   "
95433|NCT01807975|"~     A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis~     obliterans syndrome in patients with pulmonary transplant (time difference in detecting~     distal airways functional impairment by forced oscillation and the standard technique using~     spirometry).~   "
95434|NCT01807962|"~     We hypothesize that local ultrasound guided injection with corticosteroid and local~     anaesthetic are effective on the symptoms of GTPS.~   "
95435|NCT01807949|"~     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination~     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)~     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator~     (CFTR) gene.~   "
95436|NCT01807936|"~     Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with~     radical lymphadenectomy remains the basic method of management of this malignancy. Lymph~     node metastasis is one of the most important factors in predicting the prognosis of patients~     with esophageal carcinoma, but the extent of lymph node dissection is still in debate, and~     there is no statistical evidence based on large scale prospective randomized trials with~     regard to the issue that which is the optimal extent of lymphadenectomy for esophageal~     cancer. The purpose of this study is to test two different extents of lymphadenectomy~     (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal~     two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This~     research is being done to see whether one extent of lymphadenectomy is superior than the~     other with better long-term outcome and acceptable postoperative short-term outcome or not.~   "
95437|NCT01807923|"~     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination~     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)~     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator~     (CFTR) gene.~   "
95930|NCT01801488|"~     Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to~     identify a genetic difference between the two types of aneurysms; and to test SNP's in~     arteriovenous malformation tissue to identify a genetic link.~   "
95439|NCT01807897|"~     The purpose of this study is to compare three treatment modalities for central, or mixed~     obstructive and central, sleep apnea in patients with chronic heart failure and reduced~     ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and~     continuous positive airway pressure (CPAP). The main outcome measures will be left~     ventricular ejection fraction on echocardiogram and peak oxygen consumption on~     cardiopulmonary exercise testing.~   "
95440|NCT01807884|"~     The purpose of this study is to evaluate the impact of an optimized suctioning procedure on~     the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of~     amylase enzymatic activity.~   "
95441|NCT01807871|"~     Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and~     patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products~     tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe~     to continue NM upon a lapse and that doing so dramatically increases success at quitting.~     The investigators will test this by doing a randomized trial in which all treatment and~     measures are done from home with paper, phone or computer surveys. The investigators will~     recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and~     5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and~     the other group will be asked to continue use of the patch if they lapse. The investigators~     will compare the groups on their success at quitting and side-effects.~   "
95442|NCT01807858|"~     Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus~     Maternity and Children Training and Research Hospital, Department of Neonatology; be~     randomized to very low birth weight premature infants began eating until you are discharged~     from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium~     lactis, the addition of chicory inulin, in the other group given placebo; Patients taking~     weekly blood cultures, the presence of residues in both groups during feeding, to evaluate~     the incidence of NEC and sepsis are planned. Randomization and the number of patients~     planned to separate into groups.~   "
95443|NCT01807845|"~     Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to~     UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system~     etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link~     proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more.~     VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of~     melanoma. Therefore there is an urgent need to enrich staple foods & beverages with VD, to~     prevent deficiency.~      A novel technology was developed , for nanoencapsulating VD within casein micelles (CM)~     (natural milk protein nanoparticles). Previously we have found that the bioavailability of~     VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a~     synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.~      The main research question studied in the current project is: how will the bioavailability~     of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat~     free milk product, like nonfat yogurt.~      Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible,~     may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less~     than that in Tween 80, which is considered to be good. CM are particularly useful for~     oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk~     product is 0% fat yoghurt, chosen it for this study.~      Methods: Yoghurts will be made from 3 milk formulations:~        1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product,~          in CM.~        2. Skim milk with same dosage of VD, emulsified with Tween 80.~        3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a~          medical qualification examination, will be randomly assigned to 3 groups. Following~          over-night fasting they will each consume a 150 gr yoghurt sample as detailed above,~          and be requested to fast 2 more hours. Blood will be sampled before yoghurt~          consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of~          25(OH)D (the form of VD used as a status indicator in routine blood tests), by~          chemiluminescence immunoassay (CMIA).~      Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80,~     in 0% fat yoghurt.~      Significance of the study: With the widespread VD deficiency, decreased fat consumption and~     rising demand for using only natural ingredients there is great importance in delivery of VD~     and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of~     using synthetic emulsifiers, and it is imperative to assure the bioavailability is not~     compromised by this dramatic change.~      CM solubilize VD and help uniformly distribute it in aqueous products and protect it against~     heat, oxidation and UV.~   "
95444|NCT01807832|"~     The purpose of this study is to determine whether the capsaicin challenge can improve the~     diagnosis, treatment, monitoring and follow-up in patients with chronic cough.~   "
95445|NCT01807819|"~     The purpose of this study is to determine if analysis of heart ultrasound images with new~     software programs will provide better understanding as to the specific heart problems that~     lead to symptoms of heart failure.~   "
95446|NCT01807806|"~     This project is a partnership between Soar Technology, the University of Southern California~     (USC) Center for Innovation and Research on Veterans and Military Families (CIR) and the USC~     Creative Media and Behavioral Health Center (CM&BHC) to conduct a Safety and Effectiveness~     Study (SES) for an educational role-playing game developed by Soar Technology, Inc. The~     purpose of the intervention to be delivered by Soar Technology is to educate families and~     friends with the ultimate goal of empowering them to have a conversation with the~     veteran/service member about readjustment issues. The study will assess the safety and~     effectiveness of the provided game using personal interviews, play testing, and surveys. The~     game playing experience is hypothesized to be safe and effective with respect to having~     conversations with veterans/service members following deployment.~   "
95447|NCT01807793|"~     Stroke is the leading cause of disability, third leading cause of death, and one of the most~     resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate~     nearly double that of Euro-Americans (EA), and AA who experience a first-ever stroke are~     younger, have greater stroke disability, more post-stroke complications, and slower recovery~     compared to EA.~   "
95448|NCT01807780|"~     The purpose of this study is to determine if multiple vaccination in military personnel may~     be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome,~     autoimmune or lymphoproliferative disorders. At the same time, considering possible~     interference between different vaccines, proteins and polysaccharides, living and~     inactivated, the study aims to assess the immunogenicity and efficacy also in relation to~     the specific Human Leucocyte Antigens (HLA) genetic structure.~   "
95449|NCT01807767|"~     The objective of the study is to determine the efficacy and safety of Everolimus conversion~     in liver transplantation. Most large US liver centers transplant patients with high Model~     for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant~     trials in the US do not include patients with high MELD scores making it difficult to~     extrapolate these trial data to the patients cared for at larger liver transplant centers.~     The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the~     avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency,~     diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and~     safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two~     large centers with a vast experience in the administration of mTOR inhibitors.~   "
95450|NCT01807754|"~     This is a pilot, simulated breast cancer screening study. The goal of the study is to~     explore these scanning modalities:~      1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated~     ultrasound(AUS)~      2. Explore the utility of photoacoustic imaging as an adjunct to digital breast~     tomosynthesis(DBT)/ultrasound(US)alone.~   "
95451|NCT01807741|"~     The purpose of this study is to compare asenapine with placebo in the treatment of~     depression associated with bipolar disorder, type I over eight weeks.~      We hypothesize that patients will show significantly greater improvement with asenapine than~     placebo over eight weeks of treatment.~   "
95452|NCT01807728|"~     The objective of this study is to determine the effectiveness of different training programs~     on outcomes in persons with spinal cord injury (SCI). We are interested to see which~     programs have the greatest impact.~   "
95491|NCT01807221|"~     To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is~     safe and can help the well-being of patients with worsening chronic heart failure and either~     type II diabetes with or without chronic kidney disease or kidney disease alone. These~     treatment doses will be compared to eplerenone, another marketed drug approved to treat~     heart failure.~   "
95951|NCT01801189|"~     Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will~     alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly~     obese patients undergoing laparoscopic gastric bypass surgery.~   "
95453|NCT01807715|"~     The investigators will conduct a voluntary anonymous survey at four separate Sacramento area~     family planning clinics. The investigators will ask the staff at each facility to offer a~     survey to all women 18 and older presenting to the clinic to have a first trimester (<12~     weeks gestation) surgical abortion. Gestational age will be based on what the woman believes~     is her gestational age at presentation, before any evaluation in the clinic. Women who~     cannot understand or read the survey will be excluded. The investigators hope to implement~     the survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a~     target population of 600 women receiving surgical first trimester abortions at these two~     clinics over a 3-4 month period with a 95% confidence interval).~   "
95454|NCT01807702|"~     The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12~     hours and then undergo a breath test, have blood drawn, and cells from the inside of the~     mouth collected over a 12 hour period. The tests will be repeated at least a week later and~     subjects receive a dose of dichloroacetate (DCA)~   "
95455|NCT01807689|"~     This is a multi-center clinical study to compare the performance of a collective panel of~     salivary biomarkers to discriminate SS from non-SS in sicca cohorts recruited from three~     clinical sites with the diagnostic outcomes based on the new classification criteria for~     Sjögren's syndrome by the American College of Rheumatology (ACR) developed in 2012. This is~     not a treatment study, but a pilot study to confirm diagnostic ability of a panel of~     salivary biomarkers. All enrolled subjects must be classified as having both oral and ocular~     sicca symptoms without another autoimmune/connective tissue disease (Appendix 2). At the~     University of California in Los Angeles, using molecular techniques, we will quantify~     discriminatory biomarkers in saliva collected from enrolled subjects, who are also being~     evaluated as part of their clinical care using the standard diagnostic tests of the 2002~     AECG criteria. We also will test the performance of these biomarkers to predict the~     diagnosis of pSS according to the AECG criteria, as these are the most widely used tests to~     diagnose pSS and assess disease activity worldwide.~   "
95456|NCT01807676|"~     No prospective randomized clinical trial assessed the performance of this new device in a~     clinical setting. Consequently the aim of this study is to determine clinical performance of~     this new device compared with conventional DLT.~        -  Trial with medical device~   "
95457|NCT01807663|"~     Determing optimal time of ventilator disconnection is a challenge for both acute and chronic~     neuromuscular disease. In one case it is helpful for weanning from ventilator and in the~     other to optimize daytime ventilation in the most severe patients. The investigators propose~     to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular~     patients in both acute and chronic conditions.~   "
95458|NCT01807650|"~     The main purpose of this phase III clinical trial is to show safety and efficacy of~     Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.~   "
95459|NCT01807637|"~     The purpose of this study is to determine if transcranial direct current stimulation~     (tDCS)applied over the lower extremity motor cortex in conjunction with functional~     electrical stimulation assisted gait training (FESAGT) is effective for improving gait in~     patients with chronic stroke.~   "
95460|NCT01807624|"~     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety~     of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline~     with blood draws over 24 hours.~   "
95461|NCT01807611|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched~     related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a~     haploidentical donor HCT with additional natural killer (NK) cells.~      The investigators anticipate enrollment of 55 donors and 55 recipients.~      PRIMARY OBJECTIVE:~        -  To estimate the rate of successful engraftment at day +42 post-transplant in patients~          who receive haploidentical donor stem cell plus NK cell transplantation with TLI based~          conditioning regimen for high risk hematologic malignancy.~      SECONDARY OBJECTIVES:~        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival~          at one-year post-transplantation.~        -  Estimate incidence and severity of acute and chronic (GVHD).~        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after~          transplantation.~   "
95462|NCT01807598|"~     This pilot clinical trial studies brentuximab vedotin in treating patients with advanced~     systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab~     vedotin, can block cancer growth in different ways. Some block the ability of cancer cells~     to grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
95463|NCT01807585|"~     This is a randomized control trial comparing VenaSeal Sapheon Closure System with~     Radiofrequency Ablation.~   "
95464|NCT01807572|"~     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular~     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension,~     gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the~     United States ). In the US, 65% of adults are overweight or obese. Unfortunately, the~     treatment of choice for obesity (behavioral weight loss treatment) only results in a 10%~     reduction in body weight on average and most patients regain this weight within a few years.~     Further, most obesity prevention programs do not reduce risk for future weight gain. The~     limited success of treatment and prevention interventions may be due to an incomplete~     understanding of the processes that increase risk for obesity. Recent data suggest that~     obese adults show abnormalities in reward from food intake and anticipated food intake~     relative to lean adults, but the precise nature of these abnormalities is unclear and it has~     not been established whether these abnormalities predate obesity onset or are a consequence.~     It is vital to elucidate risk factors for obesity onset to advance understanding of~     etiological processes and determine the content of prevention and treatment programs.~      The goals of this study are to (1) determine whether adolescents at high-risk for obesity,~     by virtue of having two obese parents, show abnormalities in reward from food intake~     (consummatory food reward) and anticipated reward from food intake (anticipatory food~     reward) compared to adolescents who are at low-risk for obesity, (2) determine whether~     abnormalities in consummatory and anticipatory food reward increase risk for weight gain and~     obesity onset, (3) examine moderators that may amplify the relations of consummatory and~     anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory~     and anticipatory food reward in those participants who show obesity onset relative to those~     not showing obesity onset. Each of these goals is described in more detail below.~   "
95465|NCT01807559|"~     The objective of this multi-site observational study is to further assess the long-term~     patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing~     benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi~     Site Study (Protocol CLN006) for an additional 12 months.~   "
95952|NCT01801176|"~     It's a monitoring study. The aim is to assess the progression free survival up to 3 years.~     Patients are not treated until progression. Search for scalability predictive factors and~     registration of treatments if progression.~   "
95466|NCT01807546|"~     The primary objective of this study is to determine if tumors in patients with~     papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer~     responds to standard therapy will decrease in size following treatment with the~     investigational drug, rigosertib sodium (ON 01910.Na). A secondary objective is to determine~     if treatment with rigosertib causes any side effects.~      Rigosertib is an investigational drug, which means that it has not been approved by the U.S.~     Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a~     new anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works~     by blocking cell division in cancer cells and causing them to die.~   "
95467|NCT01807533|"~     Four hypotheses will be tested in this study:~        1. The intervention group performs better in child, parent and transactions outcomes than~          the control group throughout the follow-up period.~        2. The intervention group shows greater changes in early neurophysiological brain~          functions and transactions within the family that lead to better neurodevelopmental~          outcomes than the control group.~        3. Certain polymorphisms of the dopamine-related genes are associated with the~          neurodevelopmental outcomes in VLBW preterm infants.~        4. Very low birth weight preterm infants carrying more genetic plasticity in the~          dopamine-related genes may benefit more from the interventions than those carrying less~          genetic plasticity.~   "
95468|NCT01807520|"~     To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess~     long-term efficacy, safety and tolerability of secukinumab.~   "
95469|NCT01807507|"~     Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a~     gold standard~   "
95470|NCT01807494|"~     Hip replacement is a common surgical procedure performed to relieve the pain and disability.~     In general, the surgery consists of replacing the diseased or damaged joint surfaces of the~     hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons~     may perform this operation in several different ways. The purpose of this study is to~     compare two different methods of performing total hip replacement. The investigators~     hypothesize that subjects treated with the anterior approached may show improved function~     during the early postoperative period, but that no differences in pain or function will be~     present after the first postoperative year.~      In this study, patients that have elected to have hip replacement and consented to~     participate in the study will be randomized to have his or her hip replaced using one of two~     surgical techniques. Subjects will be randomized to be implanted using either an anterior or~     posterior approach. With the anterior approach, the study surgeon will use an incision that~     is on the front of the hip, and with the posterior approach, the incision will be more on~     the backside of your hip. The study surgeon has done more than 300 total hip replacements~     with both of these techniques.~      A baseline assessment will be conducted before hip replacement surgery that includes x-rays,~     functional tasks like getting up from a chair and stepping down a step, and three~     questionnaires about the hip, the subject's general health, and how well the subject is able~     to function. Also, subjects will be required to return to the clinic at several time points~     after surgery for follow-up visits. Follow-up visits will include hip assessments and~     questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3~     months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These~     follow-up visits are part of the study surgeon's normal routine for hip replacement~     patients, and are not extra visits as a part of this study.~   "
95471|NCT01807481|"~     The primary objective of study is to evaluate the no of patients which maintain the Hb level~     between 9.0 ~ 12.0 g/dl during the evaluation period~   "
95472|NCT01807468|"~     To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients~     with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous~     stem cell transplantation.~      To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell~     transplantation in patients with high-risk solid tumors who failed after tandem high-dose~     chemotherapy and autologous stem cell transplantation.~   "
95473|NCT01807455|"~     The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital~     Lidocaine when acne scars are treated~   "
95474|NCT01807442|"~     The purpose of the study is to understand peoples' positive emotions, like how optimistic or~     grateful they feel, after they have had a heart problem. The investigators want to determine~     whether positive emotions affect peoples' ability to follow recommendations, like following~     a healthy diet, exercising, and taking medication.~   "
95475|NCT01807429|"~     the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on~     pain control in trauma patients with closed limb fracture(s); and also compared the~     incidence of adverse events (mainly cardio pulmonary ) between two groups.~   "
95476|NCT01807416|"~     Aim of the present study will be to evaluate if the platform switching and the flat abutment~     can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft~     tissues will also be provided.~      80 consecutively inserted dental implants will be included in this study. Maxillary and~     mandibular implants will be considered, both in frontal and posterior area. After 6 to 12~     weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented.~     After 2 more months, the definitive porcelain crown will be delivered. The final outcomes~     will be collected after 1 year from implant insertion.~      Data will refer to the following timing:~      T0= implant installation T1= temporary crown cementation T2= definitive crown cementation~     T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants~     each, with different implant/abutment design.~      Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3~     Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +~     GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays,~     the mesial and distal Marginal Bone Level will be measured and compared among and between~     the groups at the 4 different timing.~      Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured~     at T0, T1, T2 and T3. Data will be statistically analyzed.~   "
95477|NCT01807403|"~     Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive~     disorder. This electrical stimulation has been tested on, and shown to be effective at,~     different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the~     efficacies of each target have never been compared directly.~      This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be~     more efficacious.~   "
95492|NCT01807208|"~     The goals of this study are two fold: 1) To learn whether a personalized patient health goal~     and reminder tool helps patients to learn more about their condition and to make changes in~     behavior and medication taking to reduce the risk of another heart attack. 2) To examine a~     blood sample to learn how patients are responding to their medications. The study team will~     enroll approximately 220 patients in the hospital recovering from a heart attack. Half of~     the patients will receive the educational tools and a copy will be sent to their outpatient~     provider.~   "
95478|NCT01807390|"~     This study will examine the perspectives of patients' undergoing surgery for lung or~     esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions~     regarding pain and surgical complications. This study will also assess a general health~     related quality of life pre-op and post-op. Additionally, it will examine the importance of~     receiving care close to home and their support system.~      Hypotheses:~        1. The data will allow investigators to better understand the willingness of patients to~          participate in prospective, randomized studies comparing minimally invasive and open~          thoracic surgery. Patients will not be willing to undergo randomization to an open~          versus minimally invasive surgical procedure.~        2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and~          documented as lesser than open surgery.~        3. Patients may be willing to accept a higher risk of complications or more post-operative~          pain if they were given the option to be cared for closer to their home.~   "
95479|NCT01807377|"~     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple~     oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight~     and obese subjects.~   "
95480|NCT01807364|"~     Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal~     hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in~     particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on~     the cardiovascular risk profile in adult CAH patients. The objective of this study was to~     evaluate the cardiovascular risk profile of adult CAH patients.~   "
95481|NCT01807351|"~     Retrospective cohort of all the patients with elevated blood sugar (but no Diabetes)~     attending the study sites from 2002 to 2007. We retrieval their records to see how many of~     them actually developed diabetes. The patient's record will be followed up to 6 years after~     their first abnormally high blood sugar checked. We will measure their parameters including~     sex, age, pay code and whether they have hypertension or not to see what factors will~     increase risk of DM development.~   "
95482|NCT01807338|"~     The purpose of this study is to document the long-term safety and tolerability after~     intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who~     participated in study sNN0031-001~   "
95483|NCT01807325|"~     The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may~     be benign, precancerous, or cancer. Current tests such as cytology (looking under a~     microscope) and tumor markers do not always give us the answer. The investigators are~     looking for genetic markers on biopsy specimens from the pancreas that will give us a better~     test for diagnosis. This study is only for diagnosing these lesions. The investigators are~     not treating any patients.~   "
95484|NCT01807312|"~     It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and~     abdominal discomfort during and after colonoscopy. Its safety and efficacy during~     colonoscopy even under sedation has been already assessed in some earlier trials. Air~     insufflation is still the standard method, however, due a lack of suitable replacement of~     equipment or technical improvement in colonoscopy.~      The investigators use radio frequency identification (RFID) technology to record the number~     of times and duration in the toilet of the patient after colonoscopy examination. These data~     may be proxies for discomfort. With application of CO2 insufflation, the times and duration~     in the toilet after examination will decrease as well as patient's discomfort after~     procedure, and further improvement of patient compliance can be anticipated.~   "
95485|NCT01807299|"~     The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may~     cause disabilities through whole life. The treatment of this disease is expensive and~     difficult. Moreover, physical exercise and omegas consumption may improve the cognitive~     functions and behavior, so it could be an interesting strategy to improve this disorder. The~     aim of the present study is to verify the effects of multiple components physical training~     and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF~     and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old~     will be selected. The volunteers will be randomly divided into four groups: Physical~     Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control~     Group (CG). The protocol of the experiment will last three months in which the OPTG will~     make physical training and receive fish oil capsules, and the PTG will make only the~     physical training and receive a placebo of fish oil. The others groups will be oriented not~     to make any type of physical training, but the OG will receive fish oil capsule, and the CG~     will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood~     analysis will be made at the beginning and at the end of the protocol.~   "
95486|NCT01807286|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given in combination with melphalan and dexamethasone that can be~     given to patients with AL amyloidosis. The safety of this drug combination will also be~     studied.~      Pomalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer~     cells to die.~      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.~     Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other~     chemotherapy to treat cancer.~      Planned Phase I/II Study terminated early during Phase I portion without continuation to~     Phase II.~   "
95487|NCT01807273|"~     Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis~   "
95488|NCT01807260|"~     To evaluate and compare the results of conventional and stepwise shock wave lithotripsy~     treatment modalities in pediatric urinary lithiasis.~   "
95489|NCT01807247|"~     The aim of the study is to evaluate the short effects of a two rehabilitation session~     commonly performed in physical therapy,~        1. muscle strengthening of the lower limbs and~        2. effort reconditioning with cyclo ergometer, on gait characteristics (kinematics,~          kinetics and electromyographic) in patients with central nervous system lesion.~   "
95490|NCT01807234|"~     The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan~     nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for~     migraine associated symptoms including nausea and allodynia.~   "
95493|NCT01807195|"~     Generally, a contrast medium is used when performing a CT scan or radiographic tests such as~     angiography because it heightens image clarity and can increase diagnosis accuracy. Despite~     these advantages, contrast media can cause allergic reactions in the body or a decline in~     renal function. Therefore, they should be handled carefully and explained sufficiently to~     the patient. For intensive care patients, the use of contrast agents has been revealed as a~     major cause of acute renal damage, and many studies have investigated this complication by~     examining incidence rates and prevention strategies. Hypothesis: Among intensive care~     patients, the group in which a contrast medium was used will have a higher risk of renal~     function decline compared with the group in which a contrast medium was not used, and,~     hence, the use of contrast media becomes a cause of renal function deterioration.~     Categorizing patients with renal function decline according to the new RIFLE criteria can~     have an association with the prognosis of intensive care patients, such as hospitalization~     period and death rate, which can promote faster intervention.~   "
95494|NCT01807182|"~     This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination~     chemotherapy works in treating patients with melanoma that has spread to other places in the~     body. Biological therapies, such as TIL, may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and~     fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving TIL after combination chemotherapy may kill more tumor cells.~   "
95495|NCT01807169|"~     The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with~     prevalence of patients on this type of therapy steadily increasing. The benefit / risk~     balance to stop or continue the APA for the digestive endoscopic procedure confronts us~     every day in clinical practice to another: the relationship thrombosis / hemorrhage.~      Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from~     the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin~     for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic~     mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The~     concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned~     gradually to the usual practice. However, these procedures are still not allowed under~     clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the~     literature.~      It is necessary to achieve a large national multicenter study, to clarify the risk of post~     recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in~     combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures~     used in daily practice by endoscopists in expert centers (clip, ligature and loop devices,~     preventive adrenalin injection).~      The aim of the MEDOC study is to determine the incidence of immediate and delayed bleeding~     after colonic polypectomy and / or EMR for patients on clopidogrel.~      It is expected in this work an incidence of post-polypectomy bleeding close to that observed~     during the implementation of these actions in the population without any anti platelet~     agents.~   "
95496|NCT01807156|"~     The purpose of this study is to learn about the effect of the investigational agent~     tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The~     investigators also plan to collect information on the likelihood to develop side effects~     while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This~     medication is designed to stop the tumor from developing new blood vessels.~   "
95497|NCT01807143|"~     This clinical trial studies genetic biomarkers in tissue samples from patients with~     osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer~   "
95498|NCT01807130|"~     Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors,~     aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac~     resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible~     patients. The investigators seek to determine if automating referral to cardiologists and~     electrophysiologists through an intelligent electronic medical record system can improve~     adherence to American College of Cardiology (ACC)/ American Heart Association (AHA) heart~     failure guideline recommended therapies.~      Study activities and population group: The AMERICA-HF trial will be a randomized,~     single-center, single blinded study comparing standard-practice provider initiated~     cardiovascular specialty referral to experimental automated medical record driven~     cardiovascular specialty referral. An investigational program will automatically screen all~     finalized electronic reports from clinically indicated transthoracic echocardiogram studies~     performed in the Duke University Echo Lab system and create an automated query to obtain HF~     ICD-9 codes. Eligible patients will be randomly assigned to participate in a registry~     (n=125) or automated electronic medical record (EMR) based subspecialty care intervention~     arm (n=125).~      Data analysis: The primary endpoint is rate of adherence (%) to ACC/AHA HF guideline~     recommended therapies at 3, 6, and 12 month follow-up among patients randomized to the~     registry compared to the intervention. Differences in characteristics (including use of~     guideline recommended therapies) will be tested using Pearson Chi-square tests for~     categorical variables and Wilcoxon two-sample tests for continuous variables. Time to event~     analysis will be performed for the secondary endpoints of hospitalization or death.~   "
95499|NCT01807117|"~     This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance~     imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon~     and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and~     diagnose rectal cancer or recurrence of colorectal cancer~   "
95500|NCT01807104|"~     The purpose of this study is to compare the short term effectiveness and return to function~     of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision~     on the front part of the hip joint) versus Posterior Approach (incision over back part of~     the hip joint).~   "
95501|NCT01807091|"~     This pilot clinical trial studies the feasibility of having induction chemotherapy in an~     outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome~     (MDS), at least 18 years of age will be examined. Treating eligible patients with induction~     chemotherapy in an outpatient setting may save in healthcare cost and improve a patients'~     quality of life.~   "
95502|NCT01807078|"~     Treatment with statins has a class I indication after percutaneous coronary intervention~     (PCI), but is often discontinued by patients due to side effects.~      Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals~     (i.e. compounds derived from foods with cholesterol lowering actions).~      It remains unknown, however, which of these two therapeutic approaches is more effective~     after PCI.~      The primary objective of this study is to compare the efficacy and tolerability of ezetimibe~     vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous~     coronary intervention.~   "
95503|NCT01807065|"~     This randomized phase II trial studies how well giving sipuleucel-T with or without~     radiation therapy works in treating patients with hormone-resistant metastatic prostate~     cancer. Vaccines may help the body build an effective immune response to kill tumor cells.~     Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether~     giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating~     prostate cancer~   "
95504|NCT01807052|"~     This trial studies biomarker expression in tissue samples from patients with bone sarcomas.~     Studying biomarker in tissue samples from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer~   "
95505|NCT01807039|"~     Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses~     undergoing surgery. It affect most seniors and accompanied by a series of complications. The~     aim of our retrospective clinical trial is to establish a thirty-day mortality rate after~     surgical solutions, mortality during hospitalization and compare the types of anesthesia~     chosen during the performance (general vs. subarachnoid anesthesia).~   "
95506|NCT01807026|"~     This study is being done for the following reasons:~      To determine the safety of LY2886721 and any side effects that may be associated with it and~     to see how much of the study drug is in the blood and the cerebrospinal fluid when one dose~     is given to healthy participants and participants diagnosed with Alzheimer's disease. It~     will also look at how safe and tolerable the study drug is when given to healthy~     participants in higher doses.~      This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B~     or C.~      Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll~     healthy participants.~      For Group A or B, participation in this research study could last up to 34 days. For Group~     C, participation could last up to 60 days.~   "
95507|NCT01807013|"~     Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and~     mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.~   "
95508|NCT01807000|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of [14C]~     Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The~     purpose of this study is to investigate how and how quickly Prucalopride Succinate or its~     break down products are excreted by analysing blood, faeces and urine samples collected~     during the study.~   "
95509|NCT01806987|"~     The purpose of this project to determine whether the KITS Program, an intervention to~     improve early literacy, prosocial and emotion and behavior regulation domains of school~     readiness, improves school readiness and school outcomes in children from socioeconomically~     disadvantaged neighborhoods.~   "
95510|NCT01806974|"~     Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many~     pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6,~     Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid~     arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti~     CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk~     of infection, both viral and bacterial.~      These new biotherapies could have an impact on periodontal status~        -  either by favouring sub gingival colonization of root surfaces by periodontal~          pathogenic bacteria and initiate periodontitis or exacerbate pre-existing~          periodontitis,~        -  or a positive modulation of the host response by inhibiting bone resorption of the~          alveolar process.~      To date, very few studies have been conducted on this subject which is really a~     translational research, involving several medical specialties.~   "
95511|NCT01806961|"~     Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete~     clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of~     follow-up.~   "
95512|NCT01806948|"~     We randomized patients who received laparoscopic surgery for benign gynecologic disease into~     double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared~     the degree of postoperative nausea and vomiting in experimental and control groups.~   "
95513|NCT01806935|"~     The purpose of the study is to assess the the effect of the study product on itching~     symptoms associated with xerotic dermatitis in aged population~   "
95514|NCT01806922|"~     Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients~     who received a combination of yoga and traditional physiotherapy were getting more~     improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga~     can improve post-stroke depression symtom.~   "
95530|NCT01806714|"~     The purpose of the study is to evaluate the effectiveness of a managed care-based HPV~     vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse~     practices and patient populations. The trial will measure the effectiveness of text~     messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV~     vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of~     preventive visits for adolescents~      The hypotheses are that text-messaged reminders to parents of adolescents will result in~     improved rates of HPV vaccine series initiation, HPV vaccine series completion, will~     decrease the intervals between vaccine doses and will improve rates of preventive care among~     adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV~     vaccination, well child care visits) for which their adolescent is due will be compared to a~     control group of parents receiving general health tips through text messages.~   "
95846|NCT01802593|"~     The goal of the present study is to evaluate the best regimen for infliximab monotherapy,~     and to evaluate if limited combination therapy with IFX and an Immunomodulator for the first~     6 months of therapy, in prior Immunomodulator failures, is superior to monotherapy with~     Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.~   "
95515|NCT01806909|"~     Background:~        -  Adenoviruses are viruses that typically cause symptoms of a cold or eye infection.~          These viruses are being tested as part of a possible new vaccine. Researchers hope that~          the adenovirus will help carry the vaccine into the body and cause an immune response.~          An immune response is the body s release of cells and substances that protect the body~          from infection. If an adenovirus vaccine can be developed, it might be used as part of~          a vaccine for malaria or other serious illnesses. Researchers want to test the~          adenovirus vaccine as a nasal spray in healthy volunteers. The vaccine is called~          AD4-H5-VTN.~        -  Because the vaccine contains a live adenovirus, there is a possibility that~          participants can infect other people. Therefore, participants' intimate contacts must~          join this study. An intimate contact is someone who the participant will kiss on the~          mouth or have sexual intercourse with during the period of this study.~      Objectives:~        -  To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers.~        -  To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others.~      Eligibility:~        -  Healthy volunteers between 18 and 49 years of age.~        -  Intimate contacts of healthy volunteers between 18 and 65 years of age.~        -  Participants must not have evidence of previous exposure to adenovirus type 4.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants who will receive the vaccine must be willing to be hospitalized for~          between 5 and 7 days. They will come to the National Institutes of Health for follow-up~          visits weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year.~          They must also avoid all vaccines (including seasonal flu vaccine) and allergy shots~          for 30 days before and after having the study vaccine.~        -  Participants will enter the hospital for the vaccine study visit. They will receive the~          vaccine as a nasal spray. Because the vaccine uses a live virus, participants may be~          contagious for the virus for up to 4 weeks. They will remain in the hospital in~          respiratory isolation for 7 days, or until they have two negative nasal washes taken 1~          day apart. A negative nasal wash means that there is no live virus in the nose.~        -  After leaving the hospital, participants will keep a diary at home for at least 3~          weeks. They will record their temperature, any symptoms, or other health changes every~          day during this time.~        -  Participants should avoid intimate contact with others for 28 days after having the~          vaccine. Intimate contact includes kissing on the mouth and sexual intercourse. Also,~          participants should not share kitchen utensils, drinking cups, towels, or hair combs~          with others. Intimate contacts will also keep track of any illnesses or symptoms they~          develop during this time.~        -  At the follow-up visits, participants will provide blood and swab samples for study.~   "
95516|NCT01806896|"~     This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of~     PF-0254920 in Subjects with Early Huntington's Disease.~   "
95517|NCT01806883|"~     The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb~     movement in chronic stroke patients following rehabilitation using the Nintendo Wii. The~     investigators hypothesize that patients will increase their use of compensatory strategies~     following this rehabilitation.~   "
95518|NCT01806870|"~     The purpose of this study is to see if taking two nutritional supplements, zinc and SAMe~     (S-adenosylmethionine), can improve lung health and immune function in persons with HIV. You~     are being asked to volunteer because you have HIV (Human Immunodeficiency Virus) and you~     take anti-retroviral therapy (ART) medications.~   "
95519|NCT01806857|"~     The purpose of this study is to determine whether Nuedexta is effective in the treatment of~     symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic~     Lateral Sclerosis (ALS).~   "
95520|NCT01806844|"~     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation~     in a non-invasive manner. Through the use of near infrared light, the difference between~     oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a~     numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no~     cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital~     cardiac arrest, low flow time and return of spontaneous circulation, this study wants to~     show the prognostic value of NIRS as extra monitoring.~   "
95521|NCT01806831|"~     The laser areas treated with biocellulose sheet from coconut juice containing~     anti-hyperpigmentation agent (biocellulose mask, Farhorm®) heal faster than vaseline~     ointment which is a standard treatment.~   "
95522|NCT01806818|"~     Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen~     in Acute Low Back Pain Patients during 7 days.~   "
95523|NCT01806805|"~     Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so~     cause a handicap in the movements of the everyday life. Response to oral medications may be~     incomplete and surgery may cause operating risk.~      Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus~     Dystonia on the severity of the myoclonus.~   "
95524|NCT01806792|"~     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,~     cholecalciferol combination tablet in patients with Osteoporosis~   "
95525|NCT01806779|"~     Previous results from the investigators' Center have shown that combination treatment with~     Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to~     replicate these findings with this study.~   "
95526|NCT01806766|"~     The purpose of this prospective, randomized study was to compare the clinical and~     radiographic results and the prevalence of osteolysis of the cementless total hip~     arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked~     polyethylene bearings on the other side in the young and active patients.~   "
95527|NCT01806753|"~     Although proper sedation is mandatory for endoscopic procedures such as endoscopic~     submucosal dissection, the effects of sedation on ESD performance and complications have not~     been fully evaluated. In the investigators previous retrospective study, en bloc resection~     and complete resection rates, and procedure time could be improved by sedation with~     continuous propofol infusion with opioid administration by anesthesiologists. However, there~     are several limitations to the study including retrospective design. The investigators aimed~     to evaluate the relationship among sedation methods, satisfaction of endoscopists or~     patients, clinical outcomes, and complications after endoscopic submucosal dissection for~     gastric neoplasia.~   "
95528|NCT01806740|"~     Primary objective :~      The main objective is to evaluate the value of DCE-MRI in prediction of response of patients~     with HCC to treatment with Sorafenib assessed by mRECIST.~   "
95529|NCT01806727|"~     This study is evaluating two approaches to improving the control blood sugar, and other risk~     factors for heart disease in overweight and obese adults with type 2 diabetes. The first~     approach has participants focus on weight loss via reducing food intake and increasing~     physical activity, while attending weekly group sessions led by trained community health~     workers for 12 months. The second approach has participants receive education on diabetes~     self management, which focuses primarily on glucose control, while attending monthly group~     sessions led by a study staff member for 12 months. We are recruiting persons with type 2~     diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing~     to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health. We will~     measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol)~     and calculate the predicted risk of heart disease, and see which intervention lowers risk to~     a greater extent at 12 months, as well as 24 months.~   "
95847|NCT01802580|"~     To evaluate whether participation in an Internet-based intervention helps improve short-term~     and long-term psoriasis treatment outcomes, in particular, adherence.~   "
95531|NCT01806701|"~     This study will examine how brain activation changes as a result of behavioral treatment for~     posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct~     functional magnetic resonance imaging (fMRI) scans before and after the widely-used~     trauma-focused cognitive behavioral therapy to better understand how the brain recovers from~     illness. This study will provide much needed information about brain abnormalities in abused~     youth, and could lead to improvements in behavioral treatments for patients who do not~     respond to current treatments.~   "
95532|NCT01806688|"~     This clinical trial is being conducted to study whether eating certain snacks will reduce~     your desire to eat and for a longer period of time compared to other snacks. The~     investigators are testing 2 different snacks. Study #1 will involve eating 2 different~     seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam~     or water. The test snack is higher in protein and/or fibre compared to the reference~     product.~   "
95533|NCT01806675|"~     The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer~     patients. We will assess the uptake of this novel radiopharmaceutical in subjects with~     breast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring~     antiangiogenesis treatment.~   "
95534|NCT01806662|"~     Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects~     most aspects of everyday life in the majority of patients. Acute inflammation and~     extensor/facial involvement is common in infants, whereas chronic inflammation increases in~     prevalence with age, as do localization to flexures. AD has a complex background~     characterized by immune activation, increased epidermal thickness in chronic diseased skin,~     and defective barrier function. In normal, healthy skin, the outer layer of the epidermis,~     the stratum corneum is made up flattened dead cells called corneocytes held together by a~     mixture of lipids and proteins. The stratum corneum and, in particular, the lipid layer are~     vital in providing a natural barrier function that locks water inside the skin and keeps~     allergens and irritants out. In people with AD, the barrier function is defective, which~     leads to dry skin. As the skin dries out, it cracks allowing allergens and irritants to~     penetrate.~      Mild AD can be controlled with emollients and topical medications. However, moderate to~     severe AD is extremely difficult to control and requires systemic treatment that is often~     unsatisfactory due to impracticality and lack of effectiveness. Only three therapeutic~     options exist for moderate to severe AD, including: 1) oral steroids 2) cyclosporine A~     (CsA), that is not widely used in the US as it is not FDA approved for AD and 3) ultraviolet~     phototherapy. Oral steroids and CsA treatments have major side effects and UV radiation~     therapy is highly inconvenient for patients. Several biologic medications, such as TNF-alpha~     inhibitors, are effective, convenient, and relatively safe therapies for psoriasis, but have~     thus far not shown efficacy in AD. Ustekinumab is a unique biologic medication that may~     specifically target AD.~      The investigators study will determine whether there is a reversal of the skin thickness and~     the immune pathways involved in the disease during treatment with Ustekinumab and what~     specific immune cells are involved. The investigators are also interested to understand how~     the clinical reversal of the disease will correlate with tissue reversal of the disease.~   "
95535|NCT01806649|"~     There is a need for more effective therapy for patients with esophageal squamous cell~     carcinoma who developed disease progression after first line therapy. Currently, there is no~     standard second-line therapy for this disease.~      BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of~     oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT~     pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this~     setting.~   "
95536|NCT01806636|"~     This registry is a post market observational, prospective, multi-center registry. It is~     designed to evaluate patient experience with the RePneu™ device for the relief of the~     emphysema symptoms and the continued collection of safety and effectiveness data on this CE~     Mark product. In addition, the registry will collect information that will serve as the~     foundation for a cost effectiveness analysis.~   "
95537|NCT01806623|"~     As for the indication of vulvovaginal candidiasis, a single oral administration of~     fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in~     Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and~     topical therapies such as vaginal tablets, pessary and cream are used clinically. The~     purpose of this trial is to confirm the efficacy and safety of single oral administration of~     fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.~   "
95538|NCT01806610|"~     The purpose of the study is to evaluate the safety, tolerability, and PK following a single~     administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on~     hemodialysis.~   "
95539|NCT01806597|"~     Purpose of the study is to demonstrate the efficacy of secukinumab versus placebo on~     palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of~     secukinumab.~   "
95540|NCT01806584|"~     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard~     practice treatment in extending the duration of primary patency after arteriovenous graft~     surgery in subjects with end-stage renal disease.~      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin~     matrix containing endothelial cells can provide a continuous supply of multiple growth~     regulatory compounds to the underlying cells within the blood vessel, while being protected~     from the effects of blood flow in the vessel(s) or complications resulting from being in~     direct contact with the point of injury.~   "
95541|NCT01806571|"~     This phase II trial studies how well daunorubicin hydrochloride, cytarabine, and nilotinib~     work in treating patients newly diagnosed with acute myeloid leukemia. Drugs used in~     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Nilotinib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Giving daunorubicin hydrochloride~     with cytarabine and nilotinib may kill more cancer cells.~   "
95542|NCT01806558|"~     A combined molecular breast imaging / ultrasound system will enable coregistration of a~     functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding~     anatomical abnormality seen on ultrasound.~   "
95543|NCT01806545|"~     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard~     practice treatment in improving the rate of AVF maturation and use in subjects with~     end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis~     access.~      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin~     matrix containing endothelial cells can provide a continuous supply of multiple growth~     regulatory compounds to the underlying cells within the blood vessel, while being protected~     from the effects of blood flow in the vessel(s) or complications resulting from being in~     direct contact with the point of injury.~   "
95545|NCT01806519|"~     Neck pain is a common problem in the western world. There is a group of people suffering~     from neck pain with a reduced ability to maintain an upright posture showing a forward head~     position and an altered muscle function.~      The aim of the study was to evaluate a motor control intervention for patients with~     persistent neck pain and a forward head posture.~      This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and~     multiple baselines.~      The tailored motor control intervention addressed the faulty postural alignment and the deep~     muscles of the cervical spine.~   "
95546|NCT01806506|"~     Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric~     bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic~     sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to~     compare outcomes of these two surgical methods in terms of weight loss, improvement of~     common comorbidities of obesity and influence on metabolic and hormonal status.~   "
95547|NCT01806493|"~     The prevalence of individuals who are classified as overweight or obese is increasing all~     over the world and it represents a primary health concern due to the relationship between~     obesity and a number of diseases, disabilities, comorbidities, and mortality. The definition~     of obesity should consider not only the increase of body weight but more precisely the~     increase in body fat mass. However, body composition evaluation is rarely performed in~     overweight and obese subjects and the diagnosis is almost always achieved just considering~     body mass index (BMI). In fact, whereas BMI can be considered an important tool in~     epidemiological surveys, different papers stated the limitations of the use of BMI in single~     individuals.~      Aim: to assess the determinants of body composition in a population of overweight and obese~     subjects and to propose a different model of estimation of fat mass (FM) in these subjects~     when more reliable equipments for the evaluation of body composition are not available.~      Methods: in 103 overweight or obese subjects ( 74 women, aged 41.5±10 years, and 29 men,~     aged 43.8±8 years); a multidimensional evaluation was performed including the assessment of~     body composition using Dual Energy X-Ray Absorptiometry (DXA), anthropometry, bioimpedance~     analysis (BIA) and biochemical parameters (total cholesterol, triacylglycerol, HDL- and LDL-~     cholesterol, free fatty acids and glycerol, glucose, insulin, C-reactive protein, plasma~     acylated and unacetylated ghrelin, adiponectin and leptin serum levels).~   "
95548|NCT01806480|"~     Although breast milk has numerous benefits for infants' development, with heightened effects~     in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter~     breastfeeding duration than mothers of term infants. One of the explanations proposed is the~     difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home~     environment. A person-centred proactive telephone support to breastfeeding mothers after~     discharge from NICU is expected to promote mothers' sense of trust in their own capacity and~     thereby facilitate breastfeeding. We hypothesize that proactive (health service initiated)~     telephone breastfeeding support offered to mothers of preterm infants after hospital~     discharge is more effective than reactive (mother initiated, and defined as usual care)~     telephone support at increasing the proportion of mothers who are exclusively breastfeeding~     8 weeks after discharge.~      A multicentre randomized controlled blinded trial has been designed to evaluate the~     effectiveness and cost-effectiveness of person-centred proactive telephone support on~     breastfeeding to mothers of preterm infants. Mothers will be informed about the study before~     discharge. Participating mothers will be randomized to either a control group or~     intervention group, immediately after discharge. Mothers will be notified to what group they~     have been randomized to through phone call or sms, depending on mother's preferences.~        -  Control group: person-centred reactive telephone support where mothers can phone the~          breastfeeding support team up to day 14 after hospital discharge.~        -  Intervention group: reactive support AND person-centred proactive telephone support in~          which the breastfeeding support team phones the mother daily for up to 14 days after~          hospital discharge.~      A stratified block randomization will be used; group allocation will be done on high or low~     SES (i.e. educational level) and by NICU. Recruitment will be performed continuously until~     1116 mothers (I: 558 C: 558) have been included. The data will be collected at eight weeks~     after discharge and at six months of infant's postnatal age using telephone interviews and~     questionnaires. Primary outcome is exclusive breastfeeding at eight weeks after discharge~     from the NICU. Secondary outcomes are breastfeeding (i.e. exclusive, partial, none and~     method), mothers satisfaction with breastfeeding, attachment, stress and quality of life in~     mothers/partners at eight weeks after hospital discharge and at six months postnatal age. A~     qualitative evaluation of experiences of providing/receiving the intervention will also be~     performed with mothers and staff respectively.~   "
95549|NCT01806467|"~     Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among~     them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the~     agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous~     pulmonary ThD in measuring CO in hemodynamically unstable patients.~   "
95550|NCT01806454|"~     the purpose of this study is to determine whether calcium supplementation is effective to~     prevent preeclampsia in Sichuang Province of china and which dose is more suitable~   "
95551|NCT01806441|"~     Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several~     lines of evidence suggest that this effect is associated with changes in the regulation of~     different genes at the intestine level involved in the cholesterol and fatty acid metabolism~     pathways. The present study will examine the impact of a short-term high fat diet versus a~     short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine~     triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer~     protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a~     critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid~     absorption. Gene expression studies will be performed on duodenal biopsies. The primary~     hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger~     ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a~     short-term low fat diet.~   "
95552|NCT01806428|"~     Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy~     improves the microcirculation of severe septic patients.~      Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients:~     Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of~     the onset of sepsis were included in a one year period.~      Interventions: Patients who had no contraindication to aPC administration received aPC at a~     dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were~     considered as controls.~   "
95553|NCT01806415|"~     This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable~     healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is~     to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in~     groups of healthy individuals and to compare the side effects and tolerability of a single~     dose of fenobam with placebo.~   "
95554|NCT01806402|"~     The purpose of the study is to repeatability, reproducibility and agreement of eye~     measurements in retina and glaucoma patients.~   "
95882|NCT01802125|"~     This clinical trial studies biomarker differences in samples from patients with~     undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in~     the laboratory may help doctors identify and learn more about biomarkers related to cancer~   "
95555|NCT01806389|"~     Goals: The overarching goals for this proposed research are to provide pilot data for a~     study to inform the FDA regarding the safety of breastfeeding infants of mothers on~     buprenorphine maintenance and to develop guidelines for the practitioner treating~     buprenorphine maintained women who wish to breastfeed.~      Background: There is an increase in the prevalence of illicit opiate use among women of~     childbearing age. Recently, a large multisite study has suggested buprenorphine as an~     alternative to methadone for use in this population. As a consequence, buprenorphine is~     likely to be delivered to larger populations of pregnant and post-partum women. The~     population of prenatally opioid-exposed neonates is a particularly vulnerable population.~     Advances in neuroscience, molecular biology and epigenetics indicate that greater attention~     should be given to strategies that prevent, reduce, or mitigate the consequences of~     significant adversity on the developing brain. Breast milk and breastfeeding offer~     significant health and other benefits that are particularly salient for this group. Today,~     there is a near complete lack of information regarding the safety of buprenorphine~     maintenance and lactation, making it unlikely that providers will endorse or mothers will~     adopt this practice.~      Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will~     be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period~     and enrollment in a parent protocol and by decision to breast feed their infants. Subject~     will provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14~     and 30 after delivery to determine buprenorphine and norbuprenorphine concentrations.~     Subjects will also provide plasma at times of peak buprenorphine levels for determination of~     buprenorphine and norbuprenorphine concentrations on the same days. Concentrations of~     buprenorphine and norbuprenorphine in the plasma of infants will be determined on~     approximately day 14 of life. The relationship between maternal dose, maternal and infant~     plasma concentrations, and breast milk concentrations of buprenorphine and norbuprenorphine~     will be determined, and ingestible infant dose calculated.~   "
95556|NCT01806376|"~     1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral~          Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study~        2. Experimental Design： A phase Ⅰ study of single-center~        3. Test drug: Subutinib Maleate capsules~        4. Sample size≥20~   "
95557|NCT01806363|"~     Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan~     and chlorthalidone.~   "
95558|NCT01806350|"~     This randomized pilot clinical trial studies pelvic floor muscle training in treating~     urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help~     control symptoms and improve physical function and quality of life in gynecologic cancer~     survivors.~   "
95559|NCT01806337|"~     Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus~     PEG-Filgrastim Followed by Alemtuzumab Consolidation~   "
95560|NCT01806324|"~     The objective of this study is:~      To evaluate the pharmacokinetics and safety of an experimental combination tablet containing~     20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to~     healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin~     and 50 mg losartan potassium tablets.~   "
95561|NCT01806311|"~     Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of~     amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg~     in healthy male volunteers.~   "
95562|NCT01806298|"~     This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity~     of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency~     (AGHD), who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD~     which was stopped at least 1 month prior to Screening and have no contraindication to the~     use of GH.~   "
95563|NCT01806285|"~     The purpose of this sample collection study is to prospectively collect respiratory viral~     clinical samples, conduct standard of care comparator testing and archive the collected~     residual samples for future testing in order to establish the clinical performance~     characteristics of the investigational instrument.~   "
95564|NCT01806272|"~     This is a open,randomized phase II trial comparing effectiveness and safety of local use of~     rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral~     mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II~     and less oral mucositis at the end of treatment.The hypothesis of the study is that the~     local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and~     more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12~     alone.~   "
95565|NCT01806259|"~     Do the use of Ketorolac in one intravenous injection at the moment of the operative incision~     reduce the number of recurrence in patient with advanced breast cancer without inflammation~     signs.~   "
95566|NCT01806246|"~     The aim of the programme is to develop a treatment model for adolescents with Chronic~     Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation~     reflecting the current knowledge about the disease, Heart Rate Variability Coherence~     Biofeedback, pacing and activity planning and some principles of cognitive behaviour~     therapy. The study is designed as a Single-Case study including 10- 15 participants.~   "
95567|NCT01806233|"~     There will be successive changes in traditional Chinese medicine rehabilitation for stroke~     patients with limb hemiparetic through therapy of acupuncture and moxibustion.~   "
95568|NCT01806220|"~     -  Saliva plays an important role in the homeostasis of the digestive tract mucosa.~        -  Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found~          in defficient concentrations in patients with gastroesophageal reflux disease (GERD)~          and reflux related laryngitis (LPR).~        -  The epidermal growth factor receptor (EGFR) signaling pathway is one of the most~          important pathways that regulate growth, survival, proliferation, and differentiation~          in mammalian cells~        -  Eperdermal growth factor receptor (EGFR) overexpression has been linked to~          hyperproliferative diseases.~        -  It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR~          expression.~        -  The objective of the current study was to try to establish a correlation between the~          expression of EGFR in the laryngeal and esophageal mucosa and the severity of~          laryngitis in adults with GERD and LPR~   "
95569|NCT01806207|"~     This was a study that compared Durolane injections to saline injections in the treatment of~     unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two~     treatments unaware of which treatment they received. The study was conducted at 13 centers~     in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study~     treatment.~   "
95570|NCT01806194|"~     The EMPOWER diabetes program is a year-long, community-based program designed to enhance~     diabetes management in rural African American women with uncontrolled diabetes. The~     treatment is delivered by community peers and follows a relative Small Changes approach.~   "
95883|NCT01802112|"~     The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to~     placebo, in reducing the colonic transit time in healthy subjects.~   "
95571|NCT01806181|"~     This study will offer a supervised exercise program and healthy eating education to women~     with breast cancer undergoing chemotherapy as a physician-referred program and measure the~     adoption, adherence and satisfaction with the intervention as well as its health effects.~     Past trials have demonstrated various health benefits of exercise yet it is not currently~     part of supportive care and few suitable programs exist in the community or outside of~     research. This study is expected to address the unique barriers related to exercise in~     breast cancer survivors and to better understand how the intervention might work in a real~     life setting.~   "
95572|NCT01806168|"~     The purpose of this study is to assess the effects of repetitive transcranial magnetic~     stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress~     disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or~     high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an~     effect on symptoms of PTSD compared to sham rTMS treatment.~   "
95573|NCT01806155|"~     Headache after major craniotomy may be a problem in taking care of the patients. The~     investigators want to identify the incidence of headache after major craniotomy and also the~     risk factors.~   "
95574|NCT01806142|"~     Several lines of evidence indicate that a significant proportion of cardiovascular disease~     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and~     perturbations, defined as the metabolic syndrome. It has been estimated that approximately~     25% of the North American adult population is living with the metabolic syndrome. Recent~     studies from the investigators group show that overaccumulation of atherogenic~     triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to~     increased production rate of intestinally derived apolipoprotein (apo) B-48-containing~     lipoproteins. This is of interest because substantial evidence exists indicating that~     elevated levels of intestinal lipoproteins are associated with increased CVD risk. In this~     regard, there is some evidence that medium-chain triglycerides (MCTs) may beneficially~     modify lipoprotein metabolism in hypertriglyceridemic patients. However, as emphasized in~     the body of this grant proposal, the specific impact of MCTs on the intestinal lipoprotein~     secretion and on expression of genes that regulate intestinal lipid absorption and~     chylomicron synthesis has not yet been investigated in humans.~      The general objective of the proposed research is to investigate the mechanisms by which~     MCTs beneficially modify intestinal lipoprotein metabolism in patients with the metabolic~     syndrome. The primary hypothesis is that MCT supplementation will decrease plasma levels of~     intestinal lipoproteins by reducing secretion of these particles.~   "
95575|NCT01806129|"~     This clinical trial studies reproductive health program in patients with cancer. A~     reproductive health program may improve patients' understanding of reproductive risks and~     receipt of appropriate treatment to achieve their reproductive health goals~   "
95576|NCT01806116|"~     Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for~     patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse~     remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT)~     in patients，so that there is the need to continue to look for alternative therapies.~     Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation~     and expression of silenced genes including those involved in apoptosis. The approval of~     decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit~     disease progression in transplant-eligible patients. To assess the effect of pretransplant~     decitabine treatment on post transplant outcomes, we recently reviewed our institutional~     experience with MDS and AML patients.~   "
95577|NCT01806103|"~     The purpose of the study is to determine if physician education coupled with audit and~     feedback of antibiotic prescribing can improve antibiotic prescribing by primary care~     clinicians.~   "
95578|NCT01806090|"~     This double-blind, randomized trial aims to evaluate whether uninterrupted anti-platelet~     therapy (clopidogrel) will increase the risk of bleeding associated with removal of polyp~     during colonoscopy in patients with coronary artery disease.~   "
95579|NCT01806077|"~     This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1)~     in subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk~     factors.~   "
95580|NCT01806064|"~     Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for~     TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma.~      Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1~     criteria in patients treated with axitinib and TRC105 compared to those treated with~     axitinib alone, following failure of one prior VEGF TKI~   "
95581|NCT01806051|"~     This self-controlled, prospective, pilot study is designed to gather information regarding~     the diurnal variation (changes that occur each day) in the levels of plasma phenylalanine~     (Phe) and tyrosine in patients with phenylketonuria (PKU) and in the non-PKU population.~   "
95582|NCT01806038|"~     The goal of this study is to investigate whether pharmacist provided counseling and~     medication dispensing at the patient's bedside can provide better outcomes than the current~     discharge process at Duke University Hospital. This study will be single-site, prospective,~     randomized, cohort study. Patients who meet the inclusion and exclusion criteria, and~     provide consent will be included in this study.~   "
95583|NCT01806025|"~     Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung~     infection. Usually severity is determined by the class of CF mutations, but even among~     patients with the same severity of mutations there is a variation of the severity of CF.~      Haptoglobin has several types (phenotypes), one of them was found to be related to~     infectious complications.~      In this study the investigators aim to find a correlation between Haptoglobin phenotypes in~     patients with CF and frequency of infectious complications.~      To this end the investigators will collect serum from CF patients, and determine their~     Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to~     retrospectively gathered data on infectious complications.~   "
95584|NCT01806012|"~     The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a~     randomized, single-blinded comparison to the conventional procedure. The objective of the~     study is to investigate if the use of the Enseal sealing instrument for supracervical~     hysterectomy leads to a shortening of the operation time.~   "
95585|NCT01805999|"~     Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide.~     Bulking agents such as ispaghula are used as treatments, but only half of the patients are~     satisfied with the treatment. This highlights a need for better treatment options, which~     requires a deeper understanding of the gastrointestinal fate of the products. The GI MRI~     Research group at the University of Nottingham has been developing new, non-invasive~     magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. In~     collaboration with Ironwood Pharmaceuticals, the investigators now want to understand the~     gastrointestinal fate of an ispaghula treatment, and also to improve the understanding of~     MRI parameters when they are applied to the colon.~   "
95586|NCT01805986|"~     Magnetization transfer imaging is a magnetic resonance technique that has been used over the~     last few years, and known for its ability to detect abnormalities that can be difficult to~     detect by conventional MRI techniques.~      The investigators would like to test if using an 7 Tesla MRI research scanner can help us~     diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e.~     if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated~     with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures.~     Image analysis will allow the investigators to perform lesion segmentation and sequence~     comparison between different MRI techniques. The investigators will apply computation~     techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals~     over two years will give an insight into the changes in cortical thickness over time. Based~     on obtained data the investigators will look for the relationship between lesion loads in~     White Matter and Gray Matter, cortical thickness and disease stage.~   "
95587|NCT01805973|"~     An abdominal aortic aneurysm (AAA) is an enlargement or ballooning of the main artery~     supplying high pressure blood from the heart to the body. AAAs may continue to stretch until~     they burst (rupture) causing 7000 deaths per year in the United Kingdom (UK); 2.1% of all~     deaths in men over 65. Planned repair before rupture is critical and the National AAA~     Screening Programme (NAAASP) is being introduced to identify AAAs in men before rupture.~     Screening will identify over 9000 men per year with a previously undiagnosed AAA. More than~     90% of screen detected AAAs are small, do no require repair, enter ultrasound follow-up~     (surveillance) and may benefit from exercise to improve fitness before repair.~      Over 4000 elective AAA repairs per year are performed in the UK and it has been suggested~     that exercise training and weight loss may reduce mortality and complications of AAA repair.~     This pilot study will examine the feasibility of supervised exercise training for patients~     with AAAs and determine the optimal duration of training to achieve worthwhile improvements~     in fitness.~   "
95588|NCT01805960|"~     The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF~     recurrences within 6 months after electrical cardioversion in patients with persistent AF.~   "
95589|NCT01805947|"~     In this observational study the effects of a Lifestyle Modification Program - offered as a~     semi-residential day care clinic - on pain, disability, quality of life and satisfaction~     with life will be investigated. Furthermore the influence of mindfulness, acceptance and~     coping, and acquired changes in lifestyle behaviors on the outcome after the program will be~     evaluated.~      Effects will be measured after completion of the program (3 months), and at 6 and 12 months~     follow up after start of the program, i.e. each outcome measure will be taken 4 times within~     12 months.~   "
95590|NCT01805934|"~     The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not~     satisfactory. The study aims to compare the efficacy and safety between quadruple therapy~     with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.~   "
95591|NCT01805921|"~     In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV).~      This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects~     all ages, but especially infants, adults with a suppressed immune system, and the elderly.~     RSV only infects humans and occurs in epidemics each winter. It is the single most common~     cause of severe respiratory illness in children.~      There is no effective anti-viral medication to treat RSV infections. There is a monoclonal~     antibody, which can be given to 'at-risk' children given by injection on a monthly basis~     during winter to provide short term protection against infection, but it is only partially~     effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent~     RSV infection and there remains a real need to develop a vaccine as a cost-effective method~     to save lives and reduce the cost of disease caused by RSV.~   "
95592|NCT01805908|"~     The general objective of the study is to improve the care of women with Human Epidermal~     Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by~     using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography~     (SPECT) imaging to predict who will respond to treatment with Trastuzumab.~   "
95593|NCT01805895|"~     The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral~     hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in~     intracerebral hemorrhage patients.~   "
95594|NCT01805882|"~     Background:~      - GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV)~     infection. GS-7977 may help treat the infection when used with other treatments like~     interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the~     body. Researchers want to see whether GS-7977 can be combined with any of the other three~     drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will~     take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.~      Objectives:~      - To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451~     can be used to treat HCV infection.~      Eligibility:~      Individuals at least 18 years of age who have chronic HCV infection and have never been~     treated for it.~      Individuals at least 18 years of age who have chronic HCV infection and have not responded~     to interferon therapy.~      Individuals at least 18 years of age who have chronic HCV infection with advanced liver~     disease and have never been treated for HCV~      Design:~      Participants will be screened with a physical exam and medical history. Blood samples will~     be collected. A liver biopsy may also be performed.~      Some participants will take the two study drugs and some will take three study drugs. Those~     who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC.~     Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who~     take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will~     be combined in one pill and GS-9451 will be in another pill.~      Treatment will be monitored with frequent blood tests. These tests will check liver function~     and the level of HCV infection. Participants may have other blood tests as needed for~     treatment.~      Participants will have 6, 8, or 12 weeks of treatment depending on which study drugs are~     scheduled to take. After they complete their schedule, they will stop treatment with the~     study drugs. They may also have another liver biopsy.~      Participants will have regular follow-up visits over the next 48 weeks. They will have~     physical exams and provide blood samples....~   "
95628|NCT01805440|"~     This is a randomized, double-blind, placebo-controlled study of the investigational drug~     uridine as a treatment for depressed adolescents with bipolar disorder (i.e. bipolar~     depression). Participants initially randomized to placebo who complete the 6-week protocol~     will be offered 6 months of open-label uridine treatment and follow-up. Participants~     initially randomized to uridine will be offered the open-label treatment as well.~   "
95595|NCT01805869|"~     Background:~      - The third molars (wisdom teeth) normally grow in during late adolescence or early~     adulthood. Many people need or choose to have these teeth removed with oral surgery.~     Normally, the removed teeth and tissue are thrown away as medical waste. However, oral~     health researchers want to collect the teeth and tissue for research. They also want to~     encourage dentists at the National Institutes of Health to improve their skills in oral~     surgery. This study will collect the teeth and tissue of people who need to have oral~     surgery to remove their wisdom teeth.~      Objectives:~        -  To provide continued dental skills training for dentists at the National Institutes of~          Health.~        -  To collect teeth and tissue samples following wisdom tooth removal surgery.~      Eligibility:~      - Individuals between 18 and 50 who need to have their wisdom teeth removed.~      Design:~        -  This study will involve a minimum of three visits. There will be a screening visit, a~          surgery visit, and at least one follow-up visit.~        -  Participants will be screened with a physical exam and medical history. A full dental~          exam with x-rays will be given to evaluate the need for surgery.~        -  At the second visit, participants will have oral surgery to remove their wisdom teeth.~          The teeth and tissue removed during the surgery will be collected for study.~        -  Participants will receive drugs to control the pain after surgery. They will also be~          able to contact a dentist if there are any problems.~        -  Between 7 and 21 days after surgery, participants will have a followup visit to check~          the healing. If they are having no problems, this will be the last visit. If there are~          any postsurgery issues, they will be scheduled for additional visits as needed.~   "
95596|NCT01805856|"~     The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site~     infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present~     prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean~     neck surgery associated with thyroid and parathyroid disease.~   "
95597|NCT01805843|"~     Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by~     a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal~     transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which~     inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by~     imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs~     (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they~     are proposed as second-line therapy for imatinib-resistant patients or for those who do not~     tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about >300 times in vitro in more~     than imatinib and also inhibits several other kinases, including the Src family. Src~     tyrosine kinase is crucial for potassium channel function in human pulmonary arteries.~     Imatinib and nilotinib do not inhibit the Src.~      Incident cases of precapillary PH have been reported in patients who have CML treated with~     the dasatinib. Improvements were usually observed after withdrawal of dasatinib.~      This study is designed to identify incident cases of dasatinib-associated PH and describe~     pulmonary vascular changes induced by dasatinib. As comparison population will be patients~     who receive another second-line TKI (nilotinib).~   "
95598|NCT01805830|"~     The study design of this trial is double blind, parallel-group, randomized, Placebo~     controlled study.~   "
95599|NCT01805817|"~     Oral combined contraceptives(OC) have both progesterone and estrogen inside.~     Levonorgestrel-releasing intrauterine device(LNG_IUS) has only progestagen.~      Copper IUD does not have any hormonal molecule inside.~        -  Hypothesis is OC has more systemic beneficial or side effects than LNG_IUS or copper~          IUD. LNG_IUS has more local effects than copper IUD.~        -  Study reflects the beneficial or side effects of estrogen+progestagen pills and only~          progestogen inside device.~   "
95600|NCT01805804|"~     Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to~     heart failure. The investigators aim to test hypothesis that valsartan started immediately~     after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve~     months long follow up in comparison with placebo. Echocardiographic assessment of left~     ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases~     and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP~     and distance in meters during six minute walking test.~   "
95601|NCT01805791|"~     A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate~     ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3,~     taking mesalamine (or equivalent) as a concomitant medication.~      The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine~     treatment failures). Efficacy will be measured by a comparison of the proportion of patients~     in each treatment group attaining clinical remission at Week 8 as compared to placebo.~   "
95602|NCT01805778|"~     Cancer therapy can place childhood cancer survivors at increased risk for heart disease~     which can lead to significant illness or early death. Interventions that occur late in the~     evolution of treatment-related heart disease are usually ineffective at preventing its~     progression to death or heart transplant. Our team will work in several research cores to~     test new imaging and biomarker methods that will lead to earlier detection of heart disease~     before clinical symptoms develop or it become apparent on standard imaging tests. We will~     evaluate the importance of genetic differences between individuals in determining who is at~     greatest risk of developing heart disease as a result of exposure to cardiotoxic agents. We~     will combine this genetic information with the novel imaging and biomarker methods to~     predict which children are at particular risk. These vulnerable children can then be~     targeted by modifying their cancer therapy to reduce their exposure to cardiac toxins, or~     introducing medications that protect the heart from chemotherapy damage. This team brings~     together the expertise of clinicians and scientists in pediatric oncology, pediatric and~     adult cardiology, radiation oncology, genetics, and biostatistics. This is a cross-Canada~     initiative that will leverage the latest knowledge about cardiac toxicity and create a~     resource for ongoing research into this important cause of morbidity and mortality in~     childhood cancer survivors.~   "
95603|NCT01805765|"~     The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is~     effective in alleviating menopausal symptoms and safety.~   "
95604|NCT01805752|"~     Each year, an estimated 230,000 HIV-infected women in need of services for prevention of~     mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other~     nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global~     Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These~     sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre~     health care providers and insufficient laboratory capacity to perform CD4+ cell count~     testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of~     patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell~     count testing will facilitate the ability of lower-cadre health providers to manage PMTCT~     care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant~     women in these rural, decentralized sites. A system wherein men are facilitated to accompany~     their wives to ANC appointments will create an important opportunity to address entrenched~     gender norms. The investigators therefore propose using community and facility-based~     measures to encourage male partners to accompany their spouses for ANC. As influential~     community members, male partners can assist their spouses to utilize culturally-sensitive,~     sustainable and integrated PMTCT care provided by lower-cadre providers in these~     resource-constrained settings.~      The investigators propose a parallel, cluster randomized trial to evaluate the impact of a~     family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at~     PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a~     prominent role for influential family members (male partners), working in close partnership~     with community-based health workers/volunteers. The specific aims of this study are:~        1. To evaluate whether implementation of the integrated PMTCT package in primary level~          antenatal clinics (ANC) increases the proportion of eligible pregnant women who~          initiate antiretroviral medications for the purposes of PMTCT. The investigators~          hypothesize that the provision of the PMTCT package in intervention clinics will~          improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from~          40% to 65%.~        2. To determine whether implementation of the PMTCT package improves postpartum retention~          of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum~          retention rates among mother-infant pairs attending intervention sites will be >20%~          higher at 6 weeks when compared to mother-infant pairs receiving care in~          non-intervention sites.~        3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT~          intervention compared to the existing standard-of-care referral model. The~          investigators hypothesize that the proposed intervention will be more cost-effective~          than the existing model of care.~      In addition, two qualitative evaluations will be conducted in order to:~        1. Assess client satisfaction with health services, comparing PMTCT services provided by~          lower level vs. higher level cadre health workers; and~        2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.~   "
95605|NCT01805739|"~     Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic~     stenosis for patients ineligible for open heart surgery or at high risk for perioperative~     complications. Pre-procedural imaging of the aortic root is essential for selection of the~     correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly~     subsequent embolization, coronary obstruction, annulus rupture or severe aortic~     regurgitation.~      The aim of the study is to compare the different imaging modalities for aortic root~     measurements.~      Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will~     be performed either into the aorta or into the left ventricle. The datasets will be assessed~     by blinded-independent observers in a multi-planar reconstruction view.~      The study will be performed retrospectively (2009-2012) and prospectively starting 2013.~   "
95606|NCT01805726|"~     The purpose of this study is to find the best sedation necessary for patients undergoing~     bronchoscopy. Patients are randomized to three different regimes of sedation during~     bronchoscopy were studied:~        1. - Group standard/control: local anesthesia only(C)~        2. - Group alfentanil + local anesthesia(A)~        3. - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy~          score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy~          examination. Measured parameters on the safety of examination are: the lowest~          saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and~          if the patient is ready or not to undertake bronchoscopy second time in his life if~          necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen~          are collected every 5 minutes before, during and after the bronchoscopy.~   "
95607|NCT01805713|"~     Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Caucasians.~     It results in lung disease that affects quality of life and causes early death. Lung damage~     from CF starts in infancy and continues over time. Lung damage can negatively affect how the~     lung functions. It would be ideal to measure lung damage in CF patients in three instances:~     (1) During the first year of life after diagnosis by state newborn screening programs, (2)~     In children and adults over long periods of time (years), and (3) During times of illness~     (pulmonary exacerbation), to allow for better treatment and therapy to prevent loss of lung~     function. The lung is made of elastin, collagen and cartilage. When the lung is damaged by~     CF, these components break down into pieces that can be measured in urine, sputum and blood.~     These products may represent markers of lung injury. We believe that the levels of these~     markers will be increased over time in CF patients and even higher in patients who are sick~     with lung symptoms. The goal of my research is to measure the amount of lung breakdown~     products in urine, sputum and blood in infants, children and adults with CF during times~     when well and also during times of illness. I also hope to use new technologies involving~     the study of proteins and metabolites in samples like sputum, urine and blood to help~     provide new information regarding CF lung disease. These studies will help us to better~     treat CF lung disease.~   "
95608|NCT01805700|"~     The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on~     blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive~     performance in patients with type 1 diabetes.~      Knowledge acquired may inform a wider study of the impact of these drinks.~      This is a randomised, cross over blinded study in which all participants will participate in~     the 3 arms of the study.~      The study will consist of 3 phases, each lasting 3 days. A different study drink will be~     administered during each phase. There will be an initial screening visit and a pre- study~     visit before each study phase. Each participant will make 10 visits to the research centre.~      There will be a week wash out period between each study phase. Prior to each study phase,~     there will be a 3 day caffeine and alcohol abstinence run-in period.~      Study drinks will be matched for taste and volume (as far as possible) and will be~     administered by the use of opaque cups, lids and straws to enable double-blind randomisation~     for both researcher and participants. Administration of the study drink to participants will~     be based on Latin squares to provide a balanced treatment order.~      During the 3 days study period; participants will be required to abstain from all other~     caffeine containing beverages or confectioneries.~      The secondary aim is to determine if tolerance to cardiovascular effects of~     caffeine-enhanced energy drinks is developed following acute short term ingestion.~   "
95609|NCT01805687|"~     Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable~     asthma.~   "
95610|NCT01805674|"~     In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural~     symptoms, globally worsens the quality of daily life.~      The improvement of the quality could be reached with adequate food supplements, named~     phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with~     estrogen-like and estrogen-antagonistic activity, which are active in the control of~     menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the~     psychological symptomatology also improving the quality of life.~   "
95611|NCT01805661|"~     To compare early ambulation and ability to participate in rehabilitation in patients~     undergoing total knee replacement using two different nerve block techniques for pain~     control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2)~     femoral nerve block with tibial nerve block~   "
95612|NCT01805648|"~     The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance~     treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of~     rhTPO .~   "
95613|NCT01805635|"~     The aim of this study is to assess the influence of kind of allergic disease, allergic~     profile, allergen exposure, treatment method on lung function parameters, fractional exhaled~     nitric oxide level in children suspected and being diagnosed due to allergic diseases.~   "
95614|NCT01805622|"~     -  Hypothesis 1. When compared to passive dissemination, active dissemination will result~          in greater participant enrollment.~        -  Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics~          and community sites.~        -  Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively~          correlated.~   "
95647|NCT01805193|"~     Coronary heart disease is a very common condition caused by narrowings in the blood vessel~     supplying the heart. the investigators are studying new tests to diagnose heart disease. In~     this study the investigators plan to investigate a special scan called a PET/CT (Positron~     emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to~     tell us about the flow of blood to the heart muscle.~   "
95615|NCT01805609|"~     The purpose of this study is to provide a communication training program to inpatient nurses~     and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist~     caregiving families. The importance of this training program is that it aims to teach nurses~     and social workers how and when to respond more effectively and compassionately to~     challenges faced by caregiving families. One of the goals of this program is to address~     family support needs during a patient's hospitalization.~   "
95616|NCT01805596|"~     This study is to assess the function of blood vessels while being treated with different~     types of blood thinners to determine the effect of these medications on blood vessels.~   "
95617|NCT01805583|"~     Evidence-based clinical treatments for common mental disorders, such as CBT and/or~     pharmacotherapy, have resulted in significant and sustained improvement in clinical~     symptoms. However, the individual-focused treatments rarely have sickness absence as a~     target of intervention or evaluate work-related outcomes, such as return to work. A recent~     review of the evidence for managing stress at work showed that individual interventions give~     effects on mental health measures but did not impact absenteeism at work. The purpose of~     this study is to examine the efficacy and cost-effectiveness of two different rehabilitation~     models, one based on psychotherapy and the other on workplace-interventions, when these are~     offered as standalone interventions and in combination for patients with adjustment, anxiety~     and depressive disorders.~   "
95618|NCT01805570|"~     The aim of the RAPID study is to evaluate the superiority rapid onset of action of~     Ticagrelor 360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment~     elevation myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary~     study aim is to found out clinical predictors of high residual platelet reactivity in the~     first hour after a novel oral antiplatelet agent LD.~   "
95619|NCT01805557|"~     The probability to achieve CR with R-chemotherapy in patients failing a rituximab containing~     first line regimen is quite low, in particular in cases with non GCB profile. The bioCORAL~     trial suggest that ABC subset have a dismal outcome whichever the induction treatment. Thus~     it can be argued the addition of new molecule to the RDHAP regimen could be of value.~     Bortezomib appears the best candidate in this setting as ABC subtypes constitutively express~     NFkb, which is the target of bortezomib itself. Data from the literature suggest an~     encouraging activity of R-chemo+ bortezomib in non GCB-derived DLBCL, although in small~     series. Thus, the addition of bortezomib is here justified by the need to circumvent~     constitutional resistance to chemotherapy. Published experience of the association between~     bortezomib and cytarabine are also encouraging with acceptable cumulative toxicity.~   "
95620|NCT01805544|"~     National, multicenter, prospective, observational, non-interventional study. The objective~     is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects~     treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent~     DVT and pulmonary embolism (PE) is associated with an improvement of the treatment~     satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot~     Treatment Scale (ACTS) score.~   "
95621|NCT01805531|"~     National, multicenter, prospective, observational, non-interventional study. The objective~     is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects~     treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is~     associated with an improvement of the treatment satisfaction after 3 months. The treatment~     satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.~   "
95622|NCT01805518|"~     Phosphodiesterase is a candidate for the Rx & prevention of cognitive and psychotic~     disorders. Since caffeine targets primarily PDE4(Phosphodiesterase subtype 4), caffeine~     analogs have been developed to mimic the actions of caffeine's ability to inhibit PDE-a,~     PDE4, PDE5 and adenosine-2 (AD-2)but are limited by the side effects of insomnia and~     heightened anxiety. Sildenafil (PDE-5 inhibitor) fails to enhance cognition in~     schizophrenia.~      The study of PDE-4 in cognition in Alzheimer's dementia and schizophrenia has been done~     using the PDE-4 prototypal compound, rolipram, which improves cognition in rodents. Rolipram~     reverses the memory deficits induced by amyloid fragment Abeta25-35 and Abeta1-40 peptide.~     In humans the frequent side effect of vomiting hampers translational research. The clinical~     trial of rolipram in multiple sclerosis was terminated prematurely due to serious adverse~     events with paradoxical increases in MRI MS-specific brain lesions. However, PDE-4 remains~     paradigm for cognition.~      Another strategy is chemical moieties capable of antagonizing the PDE-4 through allosteric~     modulation, rather than direct competitive inhibition hoping to minimize adverse events~     while retaining the biological potencies and functional responses of PDE-4 Modulators.~     Dietary supplements with PDE-4 effects have advantages in that small investments are needed~     to adequately study them.~      Pharmacologically active chemicals of Sceletium species are mesembrine-type alkaloids that~     have proven PDE-4 activity. The PDE-4D knockout mice have enhanced memory function mediated~     through hippocampal neurogenesis via phosphorylated cAMP response element binding protein~     (pCREB) signaling.~      This study purpose is to delineate the relationship of PDE-4 and cognition in normals. pCREB~     is possibly the putative biomarker of PDE-4 response with CREB as effector signaling pathway~     of PDE-4. CREB is close to nuclear receptors represented by BDNF (Brain Derived Neurotrophic~     Factor) and PPAR (Peroxisome Proliferator Activating Receptor) complexes. CREB changes in~     neuronal plasticity are targets for pharmacological paradigms for cognitive enhancement.~     This study will use the scelectium tortuosum as manufactured as Zembrin®. The findings in~     control subjects will form the basis for designing future studies of Zembrin® in~     neurodegenerative disorders with marked cognitive impairment such as Alzheimer's Dementia~     and Parkinson's Disease.~   "
95623|NCT01805505|"~     Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal~     ultrasound guidance was proposed recently to provide better visualization and reduce patient~     discomfort as embryo transfer can be performed with an empty bladder in this case. The~     purpose of this study is to determine whether there are any differences between transvaginal~     and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient~     satisfaction, and treatment outcome.~   "
95624|NCT01805492|"~     The purpose of this study is to characterize changes in gene and protein expression in~     peripheral blood in patients with, or at risk for, heart disease during an intensive~     lifestyle modification program.~   "
95625|NCT01805479|"~     The purpose of this study is to determine the feasibility of successfully delivering~     moderate intensity aerobic exercise training to depressed traumatic brain injury subjects~     between one and three years after injury.~   "
95626|NCT01805466|"~     The primary purpose of this study is to assess the effects of the use of EVADO with respect~     to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality.~     As secondary aim this study wants to conduct appropriate laboratory investigations in order~     to detect the major biological mechanisms potentially responsible for the beneficial effects~     of the EVADO system on the coagulation cascade and inflammatory activation.~   "
95627|NCT01805453|"~     To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema~     in newly diagnosed glioblastoma patients.~   "
95629|NCT01805427|"~     The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse~     Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according~     to the body weight or body composition and therapeutic monitoring may be necessary in~     overweight HIV patients.~      The investigators aim at measuring the individual trough concentrations of interest [at~     steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.~   "
95630|NCT01805414|"~     A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may~     not be ideal for patients with diabetes. This concern is particularly pertinent to the~     breakfast meal, which often contains mainly CHO. Clinical observations suggested that such~     diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital~     no concentrated sweets (NCS) breakfast meals with more balanced meals. The study team~     hypothesized that a balanced breakfast would improve pre-lunch BG values.~      This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward~     A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD).~     Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure~     (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All~     patients on Ward A (with and without diabetes) were given the intervention breakfast for the~     first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS~     meals). After 4 weeks, the standard and intervention wards were switched. Data were~     collected only on patients with diabetes who were able to consume meals.~   "
95631|NCT01805401|"~     In this study the investigators aim to assess whether transcranial direct current~     stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific~     brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate~     decision-making and impulse control in healthy participants.~   "
95632|NCT01805388|"~     The purpose of our study is to characterize the composition of the hard and soft tissues~     present after regenerative endodontic procedures in root canals of teeth previously~     diagnosed with the need for extraction for orthodontic treatment and incomplete root~     formation. Although the protocol addressed in this study is currently being used in clinical~     practice, there are no prospective clinical trials investigating its efficacy in stimulating~     continued root development and the nature of the newly formed tissues.~   "
95633|NCT01805375|"~     The main aims of this clinical study are to find out the maximum dose that can be given~     safely to patients, the potential side effects of the drug and how they can be managed. The~     study will also look at what happens to Anti-CD19 (DI-B4) inside the body.~      DI-B4 is a type of drug called an Anti-CD19 monoclonal antibody which is being used to stop~     the growth and kill cancerous immune cells by targeting the B-cell marker (CD-19) expressed~     on their surface. This drug has not been given to patients before.~      DI-B4 will be given weekly by intravenous infusion for four weeks. The study is in two~     parts. In Part 1, small groups of patients will be treated at increasing doses to find the~     highest safest dose and best dose for part 2 of the study. Approximately 16-20 patients will~     be treated in this part. In Part 2, the dose identified in Part 1 will be given to~     approximately 20 patients.~      Patients recruited to the study will receive four weeks (cycles) of treatment. They will~     attend an end of therapy visit eight weeks after their last dose of DI-B4, and attend~     follow-up visits up to eighteen months after their first dose of DI-B4. Information on the~     overall and progression free survival will be collected for a period up to eighteen months~     after the final patient is treated on the study.~      Patients will have blood and urine samples taken each week during treatment amongst other~     clinical tests. CT scans will be performed at the start of the study, at eight weeks post~     treatment and six months after the study start. Bone marrow biopsies and FDG-PET scans will~     only be taken if needed. Research blood samples will also be taken to look at what happens~     to the drug inside the body.~      It is important to explain that patients will have advanced cancer so it is unlikely that~     patients will benefit directly from taking part but the study may help improve future~     treatment of cancer.~   "
95634|NCT01805362|"~     Objective:~      To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given~     at bedtime compared to on awaking, and to analyze the determinants and consequences of~     aldosterone breakthrough.~      Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design:~     prospective, multicenter, randomized, controlled, open label, two parallel groups.~      Main selection criteria:~      Inclusion criteria~        -  Chronic kidney disease stage 3 to 4,~        -  ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or~          irbesartan) on awaking for at least three months,~        -  History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.~      Exclusion criteria~        -  Office blood pressure ≥ 160/100 mmHg,~        -  Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide,~          amiloride), or direct renin inhibitor.~      Evaluation criteria:~      Primary: Serum aldosterone levels at one year.~      Secondary:~        -  Serum aldosterone/renin ratio,~        -  24h urine aldosterone,~        -  Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone~          levels over baseline values,~        -  Aldosterone breakthrough defined by an increase of serum aldosterone levels over~          baseline values,~        -  HbA1c,~        -  Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,~        -  Systolic home blood pressure (SBP),~        -  Estimated glomerular filtration rate (eGFR) using the MDRD equation.~   "
95635|NCT01805349|"~     Among the risk factors for lower limb osteoarthritis, if obesity is probably the most~     studied, digital osteoarthritis received increasing interest in recent years. Recent~     publications have highlighted a link between obesity and digital osteoarthritis, but also a~     very probable link between digital osteoarthritis and structural progression of knee~     osteoarthritis. Few data including hip exist and need to be confirmed on larger scale~     studies. We have with Khoala a national multiregional cohort of symptomatic gonarthrosis~     and coxarthrosis representative of the general population (which is rarely the case in the~     literature) including X ray, clinical and biological follow-up (hips and / or knees).~   "
95643|NCT01805245|"~     The purpose of this study is to evaluate the impact of stress reduction on physiological and~     psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe~     levels of diabetes-related emotional distress. Subjects will be randomized to one of two~     interventions. We will evaluate the impact of the interventions on glucose metabolism, blood~     pressure, diabetes-related distress and quality of life. Additionally, we will investigate~     the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care~     practices as mediators in the relationship between increased stress, adverse glucose~     metabolism and elevated blood pressure in those subjects with T2DM.~   "
95644|NCT01805232|"~     Intravenous artesunate is egual to quinine in the treatment of severe malaria~   "
95645|NCT01805219|"~     The aim of the study is to validate the association of the GPS and accelerometer tools in~     order to assess the humain locomotion during exercises.~      The hypotheses are:~        1. GPS and accelerometer together can assess the human locomotion~        2. GPS and accelerometer together can assess the energy expenditure during exercises~   "
95636|NCT01805336|"~     Since many years cognitive disorders are a main topic of clinical research in Multiple~     Sclerosis (MS) as there could be observed early on in the disease and could induce with time~     in patients significant socio-professional burden. Today assessment of cognitive dysfunction~     in MS is still based on traditional pencil-paper task tests which are not able to give a~     true representation of functional burden observed in patients in real life situations. The~     development of new tools close to these life situations, i.e. more ecological, are needed~     to better assess and take in charge cognitive impairment in MS patients. One way to reach~     this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that~     simulates a realistic 3D environment where the user become immersed and interacts with it.~     These last ten years VR has known a rapid development in the health domain and has been~     applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last~     domain, virtual environment (VE) reproducing activities of daily living have been used to~     evaluate executive and memory functions as well as attentional or visuospatial processes.~     Among main VE developed, driving assessment system, navigation skills, cooking behaviors,~     virtual supermarket have shown better sensitivity to detect functional consequences of~     cognitive impairment in various neurological and psychiatric disorders than traditional~     evaluations. In Caen University Hospital, investigators used VE driving system and developed~     the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a~     user move to select and buy groceries and other things inside an interactive virtual~     supermarket using a shopping cart. In a preliminary study investigators have used this~     virtual interactive tool to evaluate executive functioning in small group of Parkinson's~     disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use~     with these two kinds of diseases. According to these results investigators planned a new~     study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving~     system and the VAP-S) to traditional attentional and executive evaluation for estimate their~     respective sensitivity to detect cognitive/functional impairment in MS patients.~     Investigators hope to shown that VR will demonstrate its interest to assess cognitive~     functions in MS and to develop cognitive rehabilitation.~   "
95637|NCT01805323|"~     This retrospective chart review study will describe the history of patients with retinal~     disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is~     administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously~     administered according to general clinical practice.~   "
95638|NCT01805310|"~     Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative~     mechanical bowel preparations in attempts to decrease the risk of infection, while also~     providing easier bowel manipulation and better visualization during surgery. However, many~     of these proposed benefits have never been proven, and usage of bowel preparations amongst~     surgeons remains highly variable. In both the general surgery and gynecology literature,~     researchers have begun to question the need for the vigorous preparations.~      Aside from surgical visualization, urogynecologists have additional concerns about how bowel~     preparations may impact postoperative bowel function given up to half of women with pelvic~     floor disorders have baseline constipation and straining is known to impact surgical~     recovery. Many studies have addressed various postoperative fiber and laxative preparations~     in attempts to improve postoperative bowel-related symptomatology, but none have~     specifically looked at preoperative bowel preparations.~      This study aims to determine if mechanical bowel preparation prior to minimally invasive~     sacral colpopexy affects patients' postoperative recovery, specifically related to bowel~     symptomatology; operative or post-operative complications; surgeons' perceptions of surgical~     difficulty directly attributed to the bowel; and post-operative return of normal bowel~     function.~   "
95639|NCT01805297|"~     To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients~     undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.~   "
95640|NCT01805284|"~     The objectives of the study are:~      (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory~     Concentration) of 100% and the time frame in which they do so. The investigators therefore~     plan to measure unbound linezolid trough concentrations before administration of the second,~     third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC~     in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or~     fifth dose, when steady state conditions are reached.~      (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this~     cohort using a population pharmacokinetic model and to assess the expected probability of~     target attainment (PTA) by MIC against MRSA.~      Twenty adult, MRSA-positive, morbidly obese patients with clinically and radiologically~     documented pneumonia are to be included. Therefore, a multi-centre, international~     observational study is necessary. Given the specific target population this study is not~     feasible in a single-centre approach. The goal is to find up to 6 centres that anticipate~     including 3 to 4 patients in the study within a time frame of one year.~      Included patients should receive at least 6 doses of linezolid. Linezolid must be~     administered intravenously (iv) over a one hour controlled infusion (with use of a~     volumetric infusion pump).~   "
95641|NCT01805271|"~     A significant number of patients relapse and eventually die, particularly if they were~     initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus~     on patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years,~     emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data).~      Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase~     (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to~     hormone resistance in breast cancer patients.~      In the present study, we plan to evaluate the benefit from adding everolimus to standard~     endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of~     relapse due to high nodes involvement (≥4) and/or persistent node involvement after~     neo-adjuvant chemotherapy.~      Genomic signatures have emerged during the last 10 years as a new and additive means to~     evaluate more precisely long term prognosis, and in some instances the amount of benefit~     from chemotherapy or endocrine therapy in the adjuvant setting. Therefore the UNIRAD study~     can be proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk~     of relapse with the EndoPredict test.~      This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting.~     The study could be practice changing in case of positive results and could allow improving~     outcome of breast cancer patients presenting high risk of metastatic relapse.~   "
95642|NCT01805258|"~     The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin~     vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and~     to investigate whether Rifampicin co-administration in clinical practice leads to a~     clinically relevant decrease of Nevirapine plasma concentrations in Indian patients~     co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities~     (especially hepatic).~   "
95646|NCT01805206|"~     During the first four days of life, intestinal fatty acid binding protein (iFABP) is~     elevated in the urine of premature babies who go on to develop necrotizing enterocolitis~     (NEC) days to weeks later. This study aims to determine whether the withholding of feedings~     in babies with an elevated urinary iFABP can reduce the incidence of NEC.~   "
95649|NCT01805167|"~     Differences in speech-understanding and the quality of the subjective perception among~     cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field~     distribution (interaction between electrodes) could also explain the disparity of the~     performances? The objective of our study was to quantify the influence of the electrical~     field interactions between the channels of stimulation according to the vocal performances~     of the implanted subjects, for various subjective levels of electric stimulation.~   "
95650|NCT01805154|"~     The intent of this registry is to understand comprehensive clinical care strategies for~     Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world~     clinical practice.~   "
95651|NCT01805141|"~     The investigators hope to learn whether perfusion CT is a useful way to assess primary~     cervical tumor microenvironment and whether there is a relationship between pretreatment~     perfusion CT measurements and primary cervical tumor size, lymph node involvement (as~     assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT~     (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy~     FDG-PET/CT).~   "
95652|NCT01805128|"~     The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental~     disorders distinct origin who share common challenges to engage and maintain social~     relationships and mutual disturbances of affective contact. An important issue of research~     is to determine the cognitive and brain mechanisms underlying social disability in these two~     pathologies. Several lines of social cognition have been systematically explored: the~     perception of emotions, the ability to attribute intentionality and mental states to others~     (theory of mind), the understanding of social situations in different contexts. We made the~     observation today that research findings clearly in the field of autism and schizophrenic~     disorders that converge on common patterns neurocognitive abnormalities. Consequently, many~     programs support published today use the same therapeutic targets and the same tools in both~     pathologies. This raises two questions of science: (1) whether the disorders of social~     cognition reported in the field of autism and schizophrenia are specific deficit and not~     specific condition, that is to say they are inherent social disadvantage whatever~     condition or (2) if these disorders of social cognition is a pattern common to autism and~     schizophrenia but are the result of specific neurocognitive mechanisms and different in each~     these pathologies. Systematic exploration of these issues is a current issue for~     understanding the pathophysiological borders between the two neurodevelopmental disorders~     but also to better define the potential targets of therapeutic strategies,~     psycho-educational and remediation of disorders of social cognition in autism and~     schizophrenia.~      Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic~     disorder, autistic or healthy in the three areas of social cognition: perception of~     emotions, attribution of intentions to others (theory of mind) and style attribution. We~     shall constitute three population groups of patients, a group of patients meeting the~     diagnosis of schizophrenia, a group of patients with autism and a control group (healthy~     subjects).~   "
95653|NCT01805115|"~     The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no~     misoprostol prior to operative hysteroscopy in premenopausal women.~   "
95654|NCT01805102|"~     PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta.~      Except for serum hCG, no pregnancy-complication markers are widely employed to predict the~     need for medical intervention. Since circulating PIF is present from very early and~     throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels~     will be analyzed in serum of pregnant women in a range of settings: a) following IVF; b)~     index pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of~     women with history of placenta mediated complications such as: intrauterine growth~     restriction, spontaneous idiopathic preterm delivery, and preeclampsia; and d) index~     pregnancy in women with evidence of abnormal placentation, namely placenta accreta and~     related conditions.~   "
95655|NCT01805089|"~     The purpose of this research study is to determine whether melatonin taken every night can~     affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen~     are normally produced in the body and may influence breast cancer risk. Melatonin is also~     naturally produced in the body. Laboratory studies have shown that melatonin may decrease~     cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot~     flashes, and mood will also be measured.~   "
95656|NCT01805076|"~     The purpose of this study is to test whether patients undergoing a breast MRI (magnetic~     resonance imaging) before breast surgery will have better results after the surgery. Breast~     tumors are routinely evaluated using mammograms and ultrasound before surgery. This study~     would like to find out if using MRI in addition to mammography before surgery improves our~     ability to evaluate tumors and decide what kind of surgery is best for the patient.~   "
95657|NCT01805063|"~     Firefighters are at increased risk of death from heart attacks when compared to other~     emergencyy service professionals whose jobs involve similar components such as emergency~     call-outs and shift work. In the largest analysis of cause of death amongst on-duty~     firefighters, firefighter deaths were classified according to the duty performed during the~     onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a~     cardiovascular cause (i.e. heart attack) occurred during fire suppression whilst this~     activity represented a relatively small amount of a firefighters professional time. There~     was also a risk of death associated with other duties such as emergency non-fire response~     and physical exertion.~      The investigators hypothesize that participation in active fire-fighting duties impairs~     blood vessel function and increases blood clot formation when compared with~     non-fire-fighting activities. In this study, healthy career firefighters will be assessed~     after three periods of duty: fire-suppression, emergency response without fire suppression~     and following a sedentary shift. The investigators will take blood samples to measure~     platelet activity (platelets are the particles in blood that help blood clot) and will~     examine how blood clots outside of the body. The investigators will then perform studies~     placing small needles in the arm to assess blood vessel function following these duties. By~     undertaking this comprehensive assessment of blood, blood vessel and heart function the~     investigators hope to understand the mechanisms whereby the risk of a heart attack, fatal or~     otherwise, is posed throughout these distinct duties that firefighters undertake on a daily~     basis.~   "
95658|NCT01805050|"~     This study shows a new technique which has been implemented at the schulthess clinic to~     improve the outcome after an correction of an anterior instability in the shoulder joint due~     to a HAGL lesion.~   "
95659|NCT01805037|"~     The purpose of this study is to evaluate how safe and effective the combination of two~     different drugs (brentuximab vedotin and rituximab) is in patients with certain types of~     lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor~     marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related~     lymphoma) and who have not yet received any treatment for their cancer, except for~     dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of~     transplanted organs (for those patients who have undergone transplantation). This study is~     investigating the combination of brentuximab vedotin and rituximab as a first treatment for~     lymphoma patients~   "
95662|NCT01804998|"~     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric~     cancer is less invasive method which can increase quality of life. For last two years,~     multicenter quality control study (Phase II) has been performed in Korea and tolerable~     results were observed. Based on these results, multicenter phase III trial is required to~     validate the clinical role of laparoscopic sentinel lymph node biopsy.~   "
95663|NCT01804985|"~     The purpose of this study is to investigate whether some patients with excellent responses~     to chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on~     either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec),~     nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the~     standard dose for 12 months, and then treatment will be stopped completely for a further two~     years. The trial information will also help to develop a de-escalation and stopping strategy~     for future newly diagnosed CML patients in the next British national CML study (to be known~     as SPIRIT3).~   "
95664|NCT01804972|"~     This study aims to determine the usefulness of providing patients with web-based~     electronically accessed patient information when compared to the provision of written~     information leaflets.~   "
95665|NCT01804959|"~     SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment.~     Probiotics may have beneficial effects on symptoms as supported by one small open-label~     study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of~     probiotics. This study aims to determine (i) whether 60 days of VSL#3 probiotics result in~     greater GI symptom improvement than placebo in SSc outpatients, assessed using an~     interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether~     60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc~     outpatients, assessed using the GIT questionnaire.~   "
95666|NCT01804946|"~     The purpose of this study is:~        -  to assess clinical efficiency of Ergoferon for treatment of influenza~        -  to assess safety of Ergoferon for treatment of influenza~        -  to compare efficiency of Ergoferon and Tamiflu for treatment of influenza~   "
95667|NCT01804933|"~     Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia~     often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The~     use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many~     anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative~     administration of muscle relaxants had to be minimized in spite of poor surgical conditions.~      This study, however, is designed to test the hypothesis that profound neuromusclular~     blockade reduces muscle trauma caused by self-retaining retractor and thus cut down~     postoperative analgesic requirement.On the other hand,profound muscle relaxation can~     decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can~     improve postoperative pulmonary function.~   "
95668|NCT01804920|"~     Presently no generally effective treatments for tardive dyskinesia (TD) are available.~     D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric~     modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous~     studies have suggested that D-serine may improve motor symptoms, including dyskinesias,~     which are caused by treatment with presently used antipsychotics drugs.~      The hypothesis under investigation in the present study is that D-serine adjuvant treatment~     may improve TD in schizophrenia patients diagnosed with this disorder.~   "
95669|NCT01804907|"~     To establish with a prospective randomized placebo-controlled study the feasibility of~     allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means~     of improving HIV/AIDS treatment adherence.~   "
95670|NCT01804894|"~     Field tests are convenient, simple tests that serve as estimates of components of athletic~     performance like power speed, and agility. It is thought clinically, that those who do best~     at these tests will perform the best in their sport and/or be the least likely to get~     injured. The converse is also thought to be true. The objective of this study is to~     administer field tests to athletes at the beginning of each season and then follow athletes~     over several years, tracking their injuries and their performance statistics. In this way,~     the investigators can determine if the clinical supposition is true and that the results of~     field tests are associated with injury or performance~   "
95671|NCT01804881|"~     Dietary management is an integral aspect of self care for many chronic diseases. Craving~     Change™ is a standard program already offered at many Family Health Teams (FHT) to patients~     interested in being more mindful of their food choices. The program helps patients~     understand why they have difficulty with modifying behaviours associated with diet,~     addresses the impact of emotion on eating behaviour and provides affect regulation~     strategies. Existing literature shows that emotion has a strong effect on food choice and~     that emotion regulation can lead to improvements in food choice. Craving Change™, however,~     is currently not selectively offered at FHTs to patients deemed to be at higher risk of~     cardiovascular disease and has not been evaluated in that context. For this study, we~     propose to 1) Selectively target patients at higher cardiometabolic risk; and 2) Evaluate an~     effect of the program (as modified to address chronic diseases) through a pilot Randomized~     Controlled Trial (RCT). If found to be effective, the modified Craving Change™ program,~     called Beyond the Fork: A health-centred approach to managing chronic disease, could be~     broadly implemented within Family Health Teams.~   "
95684|NCT01804712|"~     There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13~     released by the tumor cells. B cells release lymphotoxin which drives malignant cell~     proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine~     whether depletion of B cells by rituximab will result in a decrease in the extent of B cell~     infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy~     will be compared to that in the prostatectomy samples following administration of 4 weekly~     doses of rituximab.~   "
95696|NCT01804556|"~     Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It~     occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from~     sleep disturbance in company with pain. In the present study, we examined the effects of the~     myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg~     cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger~     points on gastrocnemius muscle.~   "
95672|NCT01804868|"~     Objective: The aim of this study is to assess the efficacy of a web tutorial based on case~     vignettes as a complementary tool for teaching literature critical assessment to nursing~     students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students'~     point of view on research participation.~      Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes~     University, Paris Diderot University and Paris 13 Nord).~      Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes~     based tutorial compared to no tutorial. In order to preserve a minimal blinding of~     participants, the comparator will be a basic passive teaching presentation on internet. The~     students will be randomized in two parallel groups. They will be evaluated on a final case~     vignette, and will be invited to follow the other intervention after evaluation. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician with a ratio 1: 1: 1. Since the students~     follow courses in different nursing institutes for each university which may have different~     teaching content and organization, the randomization will be stratified by nursing~     institute. Allocation concealment will be provided because only the statistician will have~     access to the randomization list. All the participants will receive an individual mail~     linking them to his group dedicated website. In order to preserve a minimal blinding of~     participants, the comparator will be a passive presentation and the participants will not be~     informed of the intervention evaluated and will have the opportunity to follow the other~     intervention after the evaluation. In parallel, both groups will follow normally their~     university courses.~      Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask~     a clinical problem the student will have to answer by reading a research article on a~     randomized clinical trial. Then he will have to answer questions about this article which~     are related to the major methodological points of a randomized trial. All these steps are~     available on a secure website.~      Outcomes: The primary endpoint will be the student's knowledge of critical assessment of~     randomized controlled trials. It will be measured by students' score on an evaluation case~     vignette with multiple choice questionnaires. The secondary endpoints will be the quality~     perception and acceptance of the tutorial and if the tutorial has modified their perception~     of research participation. Responses will be ranged by a 5-point Likert scale.~      Potential interests: This study takes place in the field of nursing universitary teaching.~     Nursing students have entered recently the universitary education system which enhances the~     nursing research, an emerging field in France.~      The investigators hope that this complementary teaching tool will enhance the knowledge and~     participation of nurses in research.~      Sample size expected: 506 participants.~   "
95673|NCT01804855|"~     Though face-to-face treatment of childhood obesity can be effective, it is time consuming~     and costly. This study will test whether treatment can be delivered via an Android app and~     whether such treatment reduces obesity.~   "
95674|NCT01804842|"~     This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered~     once daily in the morning (qAM), administered once daily in the evening (qPM), and~     administered twice daily (BID) on circulating glucose concentrations and metformin~     pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).~   "
95675|NCT01804829|"~     The purpose of this study is to test the safety and efficacy of Civacir® to prevent the~     recurrence of Hepatitis C Virus (HCV) after liver transplant.~   "
95676|NCT01804816|"~     Acupuncture treatment may improve the cardiac function and the quality of life in heart~     failure patients. These effects may be related to the inhibition of sympathetic activity~     and/or increased vagal function. The suppression of inflammatory reaction with acupuncture~     treatment may also be associated with these outcomes. Specific aims include:~        1. To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal~          activity~        2. To evaluate the effect of acupuncture treatment on cardiac function and functional~          capacity~        3. To evaluate the general health score of the quality-of-life with acupuncture treatment~        4. To explore the mechanism of acupuncture treatment on inflammation and nitrative stress~          in heart failure patients.~   "
95677|NCT01804803|"~     The study aims to validate the clinical efficacy of a telemedicine- and web-based system~     platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms~     of improved metabolic control, assessed by measuring changes in HbA1c, in insulin-treated~     diabetic patients. The system platform involves (i.) systematic (real-time and anywhere)~     transmission of SMBG data to a decision supported software (DSS)-assisted server, (ii.)~     web-based analysis of data, and (iii.) feedback on patients and medical staff to implement~     metabolic control. The expected outcome is that using this telemedicine-based system with~     transmission of SMBG data, web-based analysis of data and medical feedback to patients and~     medical team will improve glucose control in insulin-treated individuals with type 1 or type~     2 diabetes mellitus.~   "
95678|NCT01804790|"~     National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing~     neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy~     (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.~   "
95679|NCT01804777|"~     The purpose of this study is to determine with the administration of amiloride, observe an~     enhanced natriuresis, reduction in blood pressure and weight compared to the administration~     of hydrochlorothiazide in Type 2 Diabetics.~   "
95680|NCT01804764|"~     Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high~     mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis~     Campaign (SSC) recommends a first 6 hours resuscitative bundle to improve patient's~     outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of~     the guidelines and several difficulties in their clinical implementation. In recognition of~     this, a sepsis six bundle is designed to facilitate early intervention with just three~     diagnostic and three therapeutic steps to be delivered by staff within 1 h.~      The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI)~     could improve septic patient's outcome in no Critical Care Units. The second endpoint is to~     evaluate if the compliance to the sepsis six bundle could improve after this sort of~     intervention.~   "
95681|NCT01804751|"~     The purpose of this study is to build a model for the prediction of adverse perinatal~     outcome for preeclampsia in china~   "
95682|NCT01804738|"~     This study aims to test the following hypothesis in healthy lean young men:~        -  There are differences in glycemic response (GR) and insulin response (IR) between~          Chinese, Malay and Asian-Indian~        -  There are differences in GI values to the same food between ethnic groups~        -  There are ethnic differences postprandial GR and IR for high vs low GI foods~        -  Mastication, salivary amylase activity, gastric emptying rate and gut microbiota~          composition influences inter-individual glycemic and insulinemic variability~        -  Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and~          gut microbiota composition determines the inter-ethnic glycemic and insulinemic~          variability~   "
95683|NCT01804725|"~     The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a~     man's reproductive organs. It has been shown that bicycle riding can affect a man's ability~     to have an erection. Each year, newer and better bicycle seats come out but these seats have~     not been adequately studied for their effects on blood flow in the genital region.~   "
95695|NCT01804569|"~     There will be significant differences between control and experimental group after the~     moxibustion intervention as to, subjective physical symptoms and quality of life.~   "
95685|NCT01804699|"~     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition that may~     cause life threatening irregular heart rhythms that often manifest as unexpected cardiac~     arrest or sudden death in early adulthood. The condition is difficult to diagnose and often~     is not noticed until a family member suffers a cardiac arrest or death.~      The Canadian National ARVC registry will collect data from Inherited Heart Rhythm Clinics~     across Canada.~      STUDY OBJECTIVES:~      Primary:~        1. To determine the natural history of ARVC (short/intermediate term), including risk of~          symptomatic arrhythmias and sudden death, for patients with the phenotype and those~          gene positive patients without phenotype evidence of disease.~        2. To understand risk factors for sudden death/appropriate ICD use in ARVC, including test~          characteristics/performance and their relationship to outcomes (ECG, Holter, signal~          averaged ECG, loop recorders, imaging, voltage mapping, T wave alternans, cardiac~          biopsy and biomarkers).~        3. To establish a phenotype genotype correlation, including comparison of patients with~          disease causing mutations, variants of unknown significance (VUS) and Task Force~          Criteria (TFC) positive, gene negative patients~   "
95686|NCT01804686|"~     The purpose of this study is to collect long-term safety and efficacy data for participants~     treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for~     participants who are currently enrolled in PCI-32765 studies that have been completed~     according to the parent protocol, are actively receiving treatment with PCI-32765, and who~     continue to benefit from PCI-32765 treatment.~   "
95687|NCT01804673|"~     The purpose of this study is to evaluate the safety and tolerability of the fentanyl~     iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical~     practice for management of acute (a quick and severe form of illness in its early stage)~     moderate to severe post-operative pain (pain after surgery) including the comprehensibility~     and usefulness of the accompanying information material.~   "
95688|NCT01804660|"~     This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV~     transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal~     population. This study is important for establishing a baseline to analyze results obtained~     in MS patients (another dedicated study is performed in parallel in MS patients). The study~     will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level,~     MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by~     cytokines levels will be analysed to define control levels in the normal population and~     their variation during one year. The data obtained in this study in healthy controls will be~     compared to those obtained in a parallel similar study, GN-E-002, conducted in different~     types of MS patients.~   "
95689|NCT01804647|"~     This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV~     transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients.~     The study will be conducted over one year in four cohorts of patients with different forms~     of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and~     secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who~     have suffered a single clinical event but do not comply with diagnosis criteria for definite~     MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution~     of patients and with the reverse transcriptase activity, inflammatory markers assessed by~     cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003,~     is performed in parallel and is part of another dedicated protocol).~   "
95690|NCT01804634|"~     The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical~     bone marrow, post-transplant cyclophosphamide and sirolimus is safe and feasible for~     patients with very high-risk solids tumors.~   "
95691|NCT01804621|"~     The purpose of the study is to implement a randomized control trial testing effects of~     information scanning on cancer prevention and screening behaviors in a population sample of~     50-70 year olds. Participants will receive one of five versions of an e-newsletter~     once/month for 12 months and will be asked to complete baseline, mid-point, and~     end-of-project surveys.~   "
95692|NCT01804608|"~     Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip~     muscle strengthening versus hip muscle strengthening and sensory motor training in lower~     limbs.~   "
95693|NCT01804595|"~     This is a randomized controlled trial testing the efficacy of 4 sun protection~     interventions--education only; education and mailed sunscreen; education and text message~     reminders; and education, mailed sunscreen, and text message reminders--among Michigan~     Operating Engineers. Pre- and post-intervention surveys will be collected to determine~     changes in sunscreen use and sun burning, the primary outcome variables. The investigators~     hypothesize that all interventions will increase sunscreen use and reduce burning and that~     the education-only intervention will have the least effect of the 4 interventions while the~     education, mailed sunscreen, and text messaging arm will have the greatest effect.~   "
95694|NCT01804582|"~     Family-centered mental health treatment of children values and supports the role of parents~     in their child's recovery. However, medications are often the primary focus in community~     treatment. Young children, even preschool-age youth, are increasingly being treated with~     antipsychotic medication for serious mood and behavior problems. This medication may be~     necessary to address safety issues (such as severe aggression), but it can cause serious~     side effects, such as obesity. Also, medication-only treatment does not follow recommended~     care for these types of problems. Psychosocial treatments (for example, programs that coach~     and empower parents to manage their child's difficult behaviors) are highly recommended as~     part of comprehensive (medication and psychosocial) child treatment. Parent involvement in~     psychosocial treatment has clear benefits for their child's mental health and, unlike~     medication, the effects can last long after treatment is completed. However, problems~     related to access (for example, long waiting lists) and use (for example, parent mistrust of~     mental health services) of services are common. Maryland, like other states, has developed a~     system to improve medication safety by reviewing health information about the child to~     determine if the treatment is appropriate. This review reduces unnecessary medication~     treatment and makes sure that children have adequate health screening before starting any~     treatment. Children who are approved for medication treatment have moderate-to-severe mental~     health problems, which supports their need for comprehensive (medication and~     psychosocial)treatment, instead of medication-only treatment. In this study, investigators~     are partnering with parents/family advocates, child-serving agencies, and health providers~     to develop a Family Navigator Service to link with this medication program. Family~     Navigators are individuals who have cared for their own child with mental illness. The~     navigators will support parents, provide information on psychosocial treatment options, and~     address barriers to using services. The goals of this program are to improve use of~     psychosocial services, and to improve parent empowerment, support, and satisfaction with~     their child's mental health treatment. The investigators also expect that the Navigator~     Service will improve the child's overall mental health and reduce the likelihood that he/she~     will need a medication dose increase or another medication added over the initial treatment~     period. The Navigator Service will be provided for parents of public insured children who~     are 10 years old and have just been approved for antipsychotic medication treatment. The~     Navigator Services will be provided by phone, so this service can support families in both~     rural and urban settings. The investigators' long term goal is to develop a Family Navigator~     program that strongly supports Family-centered treatment of children and can be used to help~     families in other underserved areas beyond Maryland.~   "
95699|NCT01804517|"~     Headache disorders are prevalent, disabling, under recognized, under diagnosed and under~     treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment~     of migraine is based on patient education (lifestyle habit modification, trigger avoidance),~     and pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a~     repartition of tasks between different health professionals.~      In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache~     Centers, and a headache nurse was judged as an essential component of such centers.~      Gaul has reviewed the structured multidisciplinary approach that could be used in a headache~     centre and the existing studies using such structures. Five studies did include a headache~     nurse. No study did observe the impact of a nurse only. Resources in medical care are~     limited. One study did use a program of 96 hours, which does not seem realistic on the~     long-term and for a large pool of patients in a public hospital. Patients are not always~     able to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do,~     finding a specialized therapist for chronic headache is difficult. Defining the role of a~     nurse and demonstrating the impact on patient care is therefore a first step in the concept~     of a headache center. Possible roles of a headache nurse according to Gaul are patient~     education, follow-up of the treatment plan, addressing patient queries, and monitoring of~     patient progress. The headache nurse may also participate in research projects. In a~     hospital Headache Clinic, the nurse may be involved in intra-venous treatments and blood~     sampling for research.~      In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking.~     We propose to study this aspect prospectively. A study with positive findings would~     encourage health ministers to fund and support headache nurses for headache centers across~     Canada for headache management. Chronic headache and therefore chronic migraine would be a~     focus of such centers, since most patients seen in specialized centers are chronic.~      HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM~     Migraine Clinic to improve treatment outcome, and reduce the burden of headache. This~     multidisciplinary approach will also allow a higher efficiency of the team.~   "
95700|NCT01804504|"~     The project is aimed at investigating the effect of nutrition education on knowledge,~     attitude and practice (KAP)of subjects who are frequently eating out, and the effect on~     metabolic parameters.~   "
95701|NCT01804491|"~     The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in~     patients with a hallux rigidus, before and after different type of surgery.~   "
95702|NCT01804478|"~     SPECIFIC AIMS~      The limbs of diabetic patients are associated with decreases in capillary density, arterial~     inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing~     and viability of tissue, especially in patients with peripheral vascular disease and~     diabetes. The investigators hypothesize that mild external compression can restore the~     decreases in skin and muscle blood flow and that there would be greater increases in~     microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow~     will be measured using Photoplethysmography (PPG) before, during, and after external~     compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS).~      The specific aims are:~        -  To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF)~          microcirculatory alterations in the leg and foot caused by mild external compression in~          healthy subjects and patients with diabetes.~        -  To measure muscle oxygenation changes in the leg and foot caused by mild external~          compression in healthy subjects and patients with diabetes.~        -  To optimize pressures of Continuous Compression to induce maximum microcirculatory~          blood flow in healthy subjects and patients with diabetes.~        -  To optimize compression pressures, duration, and frequency of Intermittent Pneumatic~          Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and~          patients with diabetes.~        -  To measure microcirculatory response to compression in patients with diabetes~        -  Continue to validate of photoplethysmography as a tool for measuring microcirculation.~   "
95703|NCT01804465|"~     The purpose of this study is to find out what effects taking ipilimumab, as an immediate or~     delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients~     and their prostate cancer.~   "
95704|NCT01804452|"~     The purpose of this study is to evaluate several different tests, including brain imaging,~     eye movement testing, body fluid samples, measurements of memory and other thinking~     abilities, and measures of functional independence in the hope that this information can be~     used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our~     understanding of the biological causes of these diseases offer hope for new treatments. As~     such treatments are developed, sensitive and specific biological measurements (biomarkers)~     will be needed to provide precise and direct measures of the state of the brain, which will~     improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance~     Imaging (MRI) has previously been used to measure disease-related changes in the brain. The~     goal of this study is to identify the best methods of analysis (including eye movements,~     imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain~     biomarkers in the blood and cerebrospinal fluid might also be useful for following these~     diseases over time. This study will examine the value of blood and CSF biomarkers relative~     to brain imaging and functional measures.~   "
95705|NCT01804439|"~     Cardiovascular disease (CVD) is an important public health problem that affects millions of~     people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or~     hypertension, and prevalent CVD are well documented. However, few studies have investigated~     associations with onset of disease. The initial manifestation of CVD, for example an episode~     of unstable angina, is important because it influences the prognosis, the quality of life~     and the management of disease. Furthermore, the extent to which social deprivation, alcohol~     consumption or atrial fibrillation affects presentation of CVD is poorly understood and~     deserves further consideration.~      Most previous studies have considered CVD as a single entity. However, differences in~     aetiology between coronary phenotypes suggest that risk factors may not be shared across~     specific coronary phenotypes and their relative importance is likely to differ for each~     phenotype. Gaining knowledge of these differences could provide insights into the~     pathophysiology of specific forms of CVD and could eventually lead to modification of~     recommendations for patient management and disease prevention.~      We propose to use the linkage of the national registry of coronary events to general~     practice records in the Clinical Practice Research Database (CPRD), to investigate whether~     demographic, behavioral, and clinico-metabolic risk factors differentially influence the~     onset of specific types of CVD.~   "
95738|NCT01804010|"~     1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active~          metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine~          at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for~          4.5 days at the same doses twice daily versus placebo and to use the study results for~          bridging with Caucasian data.~        2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on~          heart rate after single and then after repeated administrations.~        3. Clinical safety of ivabradine versus placebo.~   "
95706|NCT01804426|"~     Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders.~      As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER,~     it is almost impossible to conclude who will overcome his psychiatric trauma and will be~     able to return to his normal life course and who will be thrown out of his promising life~     trajectory.~      Current attempts to identify those who are at the greatest risk are still unsatisfactory,~     which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent~     the occurrence of PTSD in a high-risk patient, might be counter-productive and even~     precipitate the emergence of PTSD in lower-risk patients.~      Since PTSD is closely related to the Fight, Flight or Freeze reaction, it has much to do~     with the autonomic nervous system and the major stress hormone, cortisol. Despite many~     studies demonstrating the involvement of those factors in the development of PTSD, various~     attempts to profile the direction of the association between PTSD and cortisol abnormalities~     have yielded conflicting results.~      The introduction of a novel method of assessing the excretion of cortisol using residues in~     the human hair shaft, has allowed an unprecedented evaluation of its activity over a~     prolonged period of time.~      Using this novel method of cortisol assessment, the investigators aim to identify biomarkers~     that will be able to aid in the prediction of PTSD development ahead of symptoms emergence,~     and will enhance the understanding of the physiological mechanism involved and etiology of~     this disorder.~   "
95707|NCT01804413|"~     Hypothesis:~      Pegvisomant combined with the glucagon stimulation test (GST) can improve the accuracy of~     this test when used to diagnose adult GH and cortisol (steroid hormone)insufficiency.~      Study aims:~      Diagnosing GH and cortisol deficiency in adults requires a special test. At present, the~     insulin tolerance test (ITT) is considered the test of choice. However, this test is~     difficult to perform as it involves giving insulin through the veins to decrease blood~     sugars to very low levels, and this can be unpleasant, and cannot be performed in elderly~     adults and in those with a history of heart disease, seizure disorders or stroke. For this~     reason there is an urgent need for an alternative reliable test. At present, the GST is~     considered the alternative test to the ITT but its accuracy in obese patients and in those~     with diabetes remains unclear. Pegvisomant is a medication that can increase GH production~     in the body. The purpose of this study is to find out if combining pegvisomant with the GST~     can help improve the accuracy of this test so that it is comparable with the ITT in~     diagnosing adult GH and cortisol insufficiency.~      Study design:~      Subjects will be recruited from the Oregon Health & Science University Dynamic Endocrine~     Testing Unit. A written informed consent will be obtained and a screening interview will be~     carried out. During the screening interview, the study will be explained to the subject in~     detail. For women of child-bearing age, a pregnancy test will be performed. The subjects~     will then take part in three studies on separate days: (1) GST; (2) pegvisomant (1 mg/kg)~     injection into the abdomen 3 days before the glucagon stimulation test (ii) insulin~     tolerance test. For the GST, glucagon will be injected into the muscle and blood draws will~     be performed every 30 mins for 240 mins. For the insulin tolerance test, a blood draw will~     be performed and insulin will be given into the vein followed by blood draws every 15 mins~     for 120 mins. The data from all three studies will be analyzed in the study where the peak~     growth hormone and cortisol levels for all three tests will be compared. A questionnaire~     will be used at the end of the study for the subjects to rank the level of preference of the~     three tests. The data of the study will be analyzed using a computer statistical program~     where the identity of the subjects will be coded to maintain confidentiality.~   "
95708|NCT01804400|"~     This study will assess the safety and efficacy of QAW039 alone and in combination with~     Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure~     chamber.~   "
95709|NCT01804387|"~     Lamivudine had been widely used for treatment-naïve chronic hepatitis B patients. However,~     development of antiviral resistance has been known as the major drawback: Incidence of~     lamivudine resistance was reported to be approximately 70% after 5 years (Lok AS et al,~     2003). For the treatment of lamivudine resistance, adefovir has been widely used (Lok AS and~     McMahon B, 2009). However, switching to adefovir monotherapy was also reported to be at high~     risk of resistance, 25% at year 2 (Yeon JE et al, 2006). Recently, adding adefovir on~     lamivudine was shown to be superior to switching to adefovir monotherapy by decreasing the~     adefovir resistance (Rapti I et al, 2007, Lampertico P et al, 2007). However, combination of~     adefovir and lamivudine does not increase antiviral activity compared with adefovir~     monotherapy in patients with lamivudine resistance (Peters MG et al, 2004). As many patients~     are still viremic with the treatment of lamivudine and adefovir over 1 year, the~     investigators need more potent combination of the drugs. Telbivudine is a new nucleoside~     analogue with potent antiviral activity. The previous phase III study has shown the~     superiority of telbivudine over lamivudine in HBeAg positive and negative subjects (Lai CL~     et al, 2007). Therefore, telbivudine plus adefovir may be a better treatment option than~     lamivudine plus adefovir for the lamivudine-resistant chronic hepatitis B patients. No study~     assessing the efficacy of telbivudine plus adefovir has been conducted for these patients.~     The aim of this study is to evaluate the safety and efficacy of telbivudine plus adefovir~     compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients~     at the end of 1 year follow-up,~   "
95710|NCT01804374|"~     This is a trial for patients affected by metastatic or relapsed osteosarcoma which~     progressed after first or further line treatments. In this trial, all patients will be~     treated until progression or unacceptable toxicity with sorafenib and everolimus. The~     treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from~     further progression of the disease after 6 months from study entry.~   "
95711|NCT01804361|"~     The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the~     patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.~   "
95712|NCT01804348|"~     Clinical diagnosis of amniotic fluid leak will be determined, according the hospital~     standard procedure, using pooling test and/or sterile speculum examination and /or pH test,~     and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)).~     Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in~     case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE~     1-Step, as observed by the patient and the clinician (positive/negative).~   "
95713|NCT01804335|"~     The goal of this clinical research study is to learn if CD5789 is safe and tolerable when~     given to patients with early stage CTCL.~      CD5789 is designed to attach to tumor cells and change their genetic material. This may stop~     the growth of the tumor cells.~   "
95802|NCT01803165|"~     In this investigation, the investigators will attempt to demonstrate that patients who have~     received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the~     lower extremities (infrainguinal bypass grafting) will have improved surgical outcomes~     namely a reduction in the rates of death, wound infection, graft thrombosis, graft revision,~     and amputation. As well, the investigators anticipate that patients who have undergone~     regional anesthesia for infrainguinal bypass grafting will have improved secondary outcomes~     with respect to a decreased length of stay, narcotic consumption, nausea and vomiting,~     post-operative cognitive dysfunction, major cardiac events, post-operative pain, and~     hyperglycemic episodes.~   "
95714|NCT01804322|"~     Epilepsy requires long-term drug treatment and is frequently associated with other clinical~     conditions. Combinations of antiepileptic drugs and other compounds are fairly common and~     increase with age. Adverse drug reactions and drug interactions are expected and may affect~     compliance, particularly in patients not receiving adequate information. Primary objective~     of the study is to verify if a comprehensive and standardized educational plan is followed~     by a significant reduction of the number of adult patients with epilepsy and comorbidity~     presenting clinically relevant adverse treatment effects. Secondary objectives include~     effects on number of adverse treatment events, health-related quality of life (HRQOL),~     direct medical costs, and patient's compliance. The study is a randomized, controlled,~     open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent~     clinical conditions on chronic treatment and at least one clinically relevant~     treatment-related adverse event and/or clinically relevant drug interaction. Eligible~     patients will be randomized to receive a comprehensive and standardized educational plan~     (experimental arm) or to usual care, ie management of adverse event/drug interaction as done~     in clinical practice (control arm). The experimental plan consists in discussing with~     patient and caregiver the cause and nature of adverse event/drug interaction, the~     tolerability profile of each drug, the clinical manifestations associated with current drug~     interaction(s), contraindications of potentially interfering over-the-counter drugs,~     indications and benefits of suggested treatment changes, and withdrawal of potentially~     interfering, contraindicated or ineffective drugs. All patients will be seen at one, three~     and six months after admission.~      Expected results: The number of patients free from clinically relevant adverse treatment~     events and/or drug interactions in each treatment arm at end of study is expected to be~     higher in patients assigned to comprehensive and standardized educational plan compared to~     usual care (primary outcome). Patients on the experimental plan are also expected to be more~     commonly free from relevant adverse events and/or drug interactions at each intermediate~     visit, to present a lower number of adverse treatment events, to imply lower costs for~     medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to~     present less weekly treatment omissions.~   "
95715|NCT01804309|"~     Regional lymph node status is the most important prognostic factor for disease-free and~     overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery.~     Today, in early-stage invasive breast cancers with clinically negative lymph nodes,~     minimally invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of~     regional lymph node staging. To optimize the effectiveness of SLNB, precise pre-and~     intraoperative mapping of lymphatic drainage is important. The (SLNB) technique is not~     standardized. The most common and most accurate way of lymphatic mapping is performed with~     the combined application of a gamma-emitting isotope labeled substance and blue dye, the~     so-called double labeling technique. Functional lymphatic drainage of SLNB double staining~     in the mammary gland, skin and axilla present a number of uncertainties.~      According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided~     the axillary region into four subregions: brachial (lateral), pectoral (anterior), central~     and subscapular (posterior) zones. They revealed clear relationship between the anatomic~     location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in~     Level I in 96% and in Level II in 4% by SPECT/CT.~      Knowedge of relationships between the drainage of sentinel lymph node staining into the~     axillary subregions, location of the primary tumor, tumor size, SLN positivity and its~     location within the subregion are of particular importance in the decision making whether or~     not axillary lymphadenectomy (ALND) needs to be performed.~      In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not~     performed in early breast cancer patients with clinically negative axilla and~     breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average~     follow-up of 6.3 years, data were compared to the traditional ALND group and no difference~     was detected in 5-year overall survival or disease-free survival at 5 years.~      Aims of the investigation:~      To examine the location of SLN in the axillary subregion (anterior, posterior, central,~     lateral, apical) in patients with early breast cancer (T <5 cm).~      To statistically assess correlations between the location, size, histological parameters of~     primary breast tumor and the subregion of the SLN.~      To statistically assess SLN positivity and its location within the sbregion.~      To statistically assess subregional localisation of positive SLN and the number of all~     positive regional lymph nodes, to predict a limited number of cases with lymph node~     metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be~     omitted.~   "
95716|NCT01804296|"~     This research proposal aims to better understand the neurobiology of depression in~     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically~     impact brain function and mood. This investigation also proposes the first study to examine~     the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria~     following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS~     response will be analyzed according to previously established protocols.~   "
95717|NCT01804283|"~     1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs~          in patients undergoing double valve replacement (aortic and mitral).~        2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic~          arrest may be rescued by ischemic postconditioning.~        3. Downstream effectors would also be affected.~   "
95718|NCT01804270|"~     This research proposal aims to better understand the neurobiology of depression in~     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically~     impact brain function and mood. This study will be the first to use a randomized,~     double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed~     adolescents. This approach will allow for the validation of rTMS treatment outcomes in the~     depressed adolescent population in a scientifically rigorous manner. The magnetic resonance~     (MR) spectroscopy pattern of rTMS response will be analyzed according to previously~     established protocols.~   "
95719|NCT01804257|"~     Feasibility study of using a digital health feedback system (DHFS) to monitor~     medication-taking and physiologic and behavioral parameters in patients with bipolar~     disorder or schizophrenia. Hypothesis: Using a digital health feedback system to~     characterize medication-taking behavior and activities of daily living is safe and tolerable~     in appropriately selected patients with bipolar disorder and schizophrenia.~   "
95720|NCT01804244|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a~     single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed~     conditions in healthy Japanese adult male participants.~   "
95721|NCT01804231|"~     Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical~     management of men with suspected recurrent prostate cancer post prostatectomy or~     radiotherapy.~      We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible~     and will lead to changes in management decisions among men being re-staged for suspected~     prostate cancer recurrence post-surgery or radiation who are potentially eligible for local~     salvage therapy.~   "
95722|NCT01804218|"~     The purpose of this study is to test the hypothesis that 18—22 week treatment with the~     inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild~     asthma, compared to placebo.~   "
95723|NCT01804205|"~     The purpose of this study is to evaluate the effects of MgSO4 administration on the~     pharmacodynamics of rocuronium in patients with 60 or more years of age.~   "
95737|NCT01804023|"~     The purpose of this study is to compare tests of vaginal insertion of applicators(visual~     inspection of returned applicators (VIRA), inspection of returned applicators under~     ultraviolet (UV) light, and DNA/protein markers) to determine which, if any, warrant use in~     a clinical trial of a new vaginal microbicide. The study will also determine whether~     indicators of semen can be detected on applicators and the degree to which they correlate~     with reported intercourse, and the correlation between vaginal bacteria detected by a~     vaginal swab and those detected from the applicator. In addition, the study will determine~     whether several factors that may be encountered in a clinical trial are likely to affect~     detection of these markers, including storage for 30 days vs. 7 days, wiping applicators~     after use, the presence of gel, and inter- and intra-woman variability. The study will also~     assess safety.~   "
95724|NCT01804192|"~     Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if~     the body has a balanced ying-yang or the qi flows in correct strength and quality along the~     meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in~     the channels and is able to regulate and restore yin-yang balance.However, there are some~     drawbacks associated with acupuncture which may limit its applications. These include~     transmission of infectious disease, pneumothorax and other problems associated with organ~     punctures, cardiac tamponade, and broken needles with remnants migrating to other~     locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is~     effective in reducing dyspnoea in patients with chronic obstructive pulmonary~     disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor~     pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy~     subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works~     still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4)~     and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the~     subject could experience distinct sensation as deqi.~   "
95725|NCT01804179|"~     There are two parts to this study: (1) an information gathering phase leading to the~     development of new educational materials; and (2) a study to test the newly developed~     material. The information gathering phase has been completed. The purpose of this part of~     the research study is to test the usefulness and acceptability of new educational materials~     investigators have developed. Investigators will compare the new educational material to~     another widely available educational brochure. The goal is to see if the new educational~     material will change knowledge and behaviors about colorectal cancer and colorectal~     screening.~   "
95726|NCT01804166|"~     This study is designed to collect tissue samples from the biopsy specimen that was used to~     diagnose HSTCL and, if possible, to obtain a single blood sample, a buccal swab sample and a~     bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In~     addition, demographic and clinical patient information will be collected. The study will be~     conducted in North America. The study population will include IBD patients in North America~     with HSTCL who are identified through the sponsor's adverse event reporting systems. Cases~     of HSTCL will be identified through postmarketing adverse event reporting (eg, spontaneous~     reports, reports from late phase clinical trials, reports from patient registries) or from~     the sponsor's new or ongoing clinical trials. Eligible for enrollment are male or female~     patients of any age who have a confirmed diagnosis of HSTCL. There is no study-related~     therapeutic intervention and this protocol will not restrict or introduce any therapeutic~     interventions, including medications. All patients will continue to be managed by their~     personal physicians. No healthy subjects will be enrolled in this study.~   "
95727|NCT01804153|"~     Evaluate the feasability and security of the autologous ASC for the femenine stress urinary~     incontinence~   "
95728|NCT01804140|"~     This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into~     clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and~     analyzed from eligible patients with solid tumors (other than metastatic melanoma or~     papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as~     defined by this screening protocol will have potential access to the separate vemurafenib~     protocol MO28072.~   "
95729|NCT01804127|"~     The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse~     large B-cell lymphoma based on the interim results of PET/CT.~   "
95730|NCT01804114|"~     The primary endpoint of this study will determine if subjects receiving a continuous~     infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain~     pump installed as described to treat post surgical pain will have a lower incidence of pain~     than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint~     of this study will determine if subjects receiving a continuous infusion of local anesthetic~     following laparoscopic ventral hernia repair, with the pain pump installed as described to~     treat post surgical pain will have a lower utilization of narcotic analgesic medication than~     those patients treated with the placebo, saline-filled pain pump.~   "
95731|NCT01804101|"~     This clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients~     with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in~     chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
95732|NCT01804088|"~     The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of~     the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease~     of the iliac arteries.~   "
95733|NCT01804075|"~     Hypothesis is that the effectiveness of opiate treatment with morphine will result in~     shorter duration of opiate medication treatment and fewer infants treated with a second~     drug.~   "
95734|NCT01804062|"~     The purpose of this study is to meet the respiration rate accuracy specifications for the~     study pulse oximeter monitoring system (study device)in a healthy volunteer population when~     compared to established technologies for measuring parameters related to respiration, such~     as Capnograph Respiration Rate (RR) (CO2).~   "
95735|NCT01804049|"~     Sarcopenia is the loss of muscle mass, strength and function with aging and is associated~     with increased disability, falls and fractures. Older adults with diabetes and prediabetes~     are insulin resistant and have a higher risk of developing sarcopenia. This study examines~     the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in~     older adults with prediabetes.~   "
95736|NCT01804036|"~     This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program~     is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will~     also investigate whether MBB is additionally beneficial for co-morbid conditions such as~     stress, PTSD, depression, etc, compared with that of Zolpidem.~   "
95832|NCT01802775|"~     This study is a randomized, open-label, blinded endpoint, parallel-group, active-control,~     multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD),~     designed to assess the safety and potential efficacy of adding edoxaban to aspirin following~     femoropopliteal endovascular intervention, with or without stent placement, relative to~     current treatment practice with clopidogrel and aspirin.~   "
95739|NCT01803997|"~     The purpose of the study is to evaluate an afterschool program to teach nutrition through~     basic cooking skills. This after school extracurricular program increases the students'~     confidence, knowledge, and skills for cooking as one of the first steps for dietary~     improvement. In addition to the life lessons students learn during this class, they gain~     self-confidence and become self-sufficient culinary experts that are capable of educating~     their siblings, parents, and social circles. This research project will test the impact this~     program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and~     out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through~     STRIDE (Science through Translational Research in Diet and Exercise at California~     Polytechnic state University (Cal Poly) in San Luis Obispo, CA.~      Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool~     cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat~     fruits and vegetables, and fruit and vegetable intake compared to an attention control~     group.~   "
95740|NCT01803984|"~     Migraine is a very common, chronic/intermittent and disabling neurovascular headache~     disorder that has long believed to have no severe consequences. Recent evidence, however,~     strongly suggest that migraine is associated with increased risk of ischemic stroke and~     there is initial evidence that migraine is associated with structural brain changes~     independent of the occurrence of stroke.~      As migraine has strong links with the vascular system, it is plausible that vascular~     functions interact on the association between migraine and structural brain changes as well~     as cognition.~      Our primary objectives are to investigate: (i) the relationship of migraine and migraine~     subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active~     migraine; (ii) the relationship of migraine on cognitive performance among patients with~     active migraine; and (iii) the relationship of migraine and migraine specifics with vascular~     functions and morbidity. As secondary objective, we investigate whether the association of~     migraine on structural brain changes or cognitive performance is modified by vascular~     functions.~      This will be an observational study conducted in the Headache Center in Bordeaux. 300~     patients have to be included (150 patients with migraine with aura and 150 patients with~     migraine without aura).~      Inclusion criteria are: all patients with a clearly defined migraine (as per~     IHS[International Headache Classification] criteria) who are aged 30 and older, are able to~     fluently speak French, and who are willing to participate.~      Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or~     major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).~      The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for~     the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use~     the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the~     depression scale CES-D (Center for Epidemiologic Studies Depression Scale).~      Vascular risk status will be assessed by measurement of blood pressure and reports of~     vascular risk factors. The endothelial function will be measured with a noninvasive~     Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical~     Inc, Framingham, MA).~      For crude comparisons, chi-square tests will be used for categorical variables and t-test~     for continuous variables. Multivariable-multinominal modeling techniques will be utilized~     for the comparisons adjusting for potential confounding variables. All statistical tests~     will be two-tailed and a P <0.05 will be considered statistically significant.~   "
95741|NCT01803971|"~     the international recommendations don't explain the place of the intraosseous infusion in~     the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the~     delay for obtaining a vascular access by evaluation of a current strategy (using~     intraosseous infusion after one peripheral venous access failure) and to determine the~     potential failure risk factors of venous access.~   "
95742|NCT01803958|"~     This study was designed and developed in the Emilia Romania research and innovation program~     (PRI ER). The study does not have commercial sponsors and comes under the independent~     studies provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a~     contribution to the study for the first three years of recruitment through the regional~     Innovation Fund, to cover the costs of coordination and data management sustained by the~     Coordinating Center.~      Primary Objectives The study proposes to evaluate whether partial hypofractionated and~     accelerated irradiation of the sole surgical cavity, in patients suffering from breast~     cancer with low risk of local recurrence and who undergo conservative surgery, is not~     inferior to postoperative irradiation with conventional fractionation of the entire breast~     as regards local control (incidence of ipsilateral recurrences as prime event).~      Secondary Objectives Comparison of the global survivals, freedom from locoregional~     recurrences (with exception for contralateral tumors and second tumors), distant~     relapse-free (except for local or regional relapses or in the contralateral breast) in~     patients treated with conventional radiotherapy and accelerated partial radiation.~      To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity~     comparable with conventional irradiation.~      Possible connection with other national and international studies Similar studies which~     nonetheless evaluate different methods of partial irradiation are currently underway.~      Study Design Multicenter phase III controlled randomized, unblinded study of~     non-inferiority.~      Number of cases Recruitment of 3302 patients is planned. Target Population of the Study~     Women aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast~     cancer, pT 1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically~     negative (³ 2 mm) at first intervention or after subsequent widening.~      Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is~     planned and a follow-up period of 5 years for an overall duration of the study of 13 years.~      Treatment~      The patients will be randomized to receive one of the following treatments:~      Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval~     of at least 6 hours between the two fractions, for five consecutive working days.~      Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week.~      Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary:~     global survival, locoregional recurrence-free, distant recurrence-free, acute and late~     toxicity (RTOG) and cosmetic result.~      Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of~     treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year~     until the end of 5 years.~      Data Analysis Partial irradiation will be considered not inferior to the standard~     irradiation if the top extreme of the HR confidence interval at 95% (to endpoint) does not~     exceed the established value of 1.5 The study was sized in relation to the rate of local~     ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the~     standard treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error~     a and b equal respectively to 0.05 and 0.10 and test at an endpoint.~      The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will~     be calculated using the Cox model and its confidence interval at 95% will be reported.~      Ethical Aspects and Informed Consent For participation in the study an informed consent is~     planned appropriately drawn up and submitted to the approval of the Ethics Committees.~      The clinical study will be carried out according to the ethical principles of the Helsinki~     Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out~     clinical studies.~      Before formal commencement of the study its approval/sole opinion by the reference Ethics~     Committee of the proposing group is stipulated. The individual investigators of the~     different participating institutions are directly responsible for the submission for~     approval of the protocol by their Ethics Committees.~   "
95743|NCT01803945|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of~     orally administered AVE8112 in patients with Parkinson's Disease (PD).~   "
95744|NCT01803932|"~     Cluster randomized controlled trial to evaluate a male-focused primary prevention programme~     which used a men's only group discussion format to prevent intimate partner violence against~     women & girls through fostering knowledge and behaviour changes by: (1) increasing men's~     knowledge on the impact of violence against women; (2) promoting gender equitable~     beliefs/behaviours within relationships; and (3) developing anger management techniques.~   "
95745|NCT01803919|"~     The purpose of this trial is to make a comparison between the use of antiseptic silver~     alloy-coated silicone urinary catheters and the use of conventional silicone urinary~     catheters in spinal cord injured patients to prevent urinary infections.~   "
95746|NCT01803906|"~     The investigators are studying patients with undefined mitochondrial diseases to identify~     genetic mutations in nuclear or mitochondrial Deoxyribonucleic Acid (DNA). Most patients~     with suspected or known mitochondrial diseases have no genetic confirmation. The~     investigators expect that evaluating tissue samples from patients with mitochondrial~     disorders will lead us to discover mutations in new or known genes causing mitochondrial~     dysfunction.~   "
95747|NCT01803893|"~     PIF: biomarker of successful implantation To overcome the poor reproductive potential of~     embryos generated during in vitro fertilization cycles and the lack of markers enabling the~     identification of the most competent ones, it is common to transfer multiple embryos.~     However this practice is associated with the risks of multi-fetal pregnancies and high~     morbidity/mortality. Ideally, the availability of a marker specifically produced by viable~     embryos would permit the transfer of a single embryo (SET) without affecting the chances of~     pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after~     IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer~     of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI~     Meeting, Hamburg, 2012) Using a non-invasive method of detection of PIF in the media~     surrounding the embryo will be correlated to live birth following single embryo transfer. By~     selecting only viable embryos, it will reduce the need for multiple IVF cycles, increase the~     rate of pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that~     has very high medical and societal costs both in pregnancy and after delivery.~   "
95748|NCT01803880|"~     The purpose of this study is to evaluate changes in clinical and imaging outcomes following~     arthroscopic treatment of a single medial femoral chondral lesion plus partial medial~     meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥~     eighteen (18) years of age.~   "
95749|NCT01803867|"~     This is a Phase I, multi-center, double-blind, randomized, placebo-controlled,~     dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and~     immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all~     clinical presentations of MS.~   "
95803|NCT01803152|"~     The use of adjuvant vaccination with autologous dendritic cells (DC) matured in situ after~     being loaded with tumor lysates derived from autologous refractory sarcoma tissue will be~     safe, feasible and potentially beneficial for patients diagnosed with sarcoma. This~     vaccination will result in evidence of immune stimulation against tumor antigens. In~     addition, combining myeloid derived supressor cells (MDSC) inhibition using gemcitabine with~     DC vaccination in this method will be safe and feasible and show improved immune parameters~     over DC vaccination without MDSC inhibition.~   "
95750|NCT01803854|"~     The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey,~     clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf~     War Era. Approved researchers will be able to use these data and the blood samples to do~     future research about the health of Gulf War Era Veterans.~      During the pilot, the recruitment response rate and processes were assessed. The results~     revealed several opportunities for improvement. For this reason, CSP 585 research activities~     are not stopping, but rather transitioning to a qualitative phase to focus more on the~     Veteran voice. In this stage, research staff will speak with Gulf War Era Veterans through~     focus groups, interviews, and other activities such as events and meetings to learn more~     about Veterans' experiences and/or ideas on this and other Gulf War research projects. This~     phase will provide new information that will help researchers create better recruitment~     processes for future projects involving Gulf War Era Veterans.~      For more information on CSP 585, please contact Kristina Felder at 919-286-0411 ext. 7379 or~     Kristina.Felder@va.gov.~   "
95751|NCT01803841|"~     The aim of this registry is to analyze several factors affecting the procedural success and~     clinical outcomes at 1 year of follow-up according to the approach site.~   "
95752|NCT01803828|"~     Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at~     baseline and a specific treatment have not been indicated. The investigators already~     demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The~     investigators' study aims to characterize DCM, measuring molecular and neuroendocrine~     assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators~     will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic~     patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A~     inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM~     features. The proposed research will test whether PDE5Ai could become a new target for~     antiremodeling drugs and to discover a molecular pathways affected by this class of drugs~     and a network of circulating markers for the early diagnosis, monitoring and prediction of~     response to treatment of DCM.~   "
95753|NCT01803815|"~     This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients~     and their pattern of antihypertensive drugs consumption. The investigators also aimed to~     investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood~     pressure control rates in these patients. Additionally, the investigators were also~     interested in trying to understand if the control of OSA may be influenced by the use of~     different classes of anti-hypertensive drugs.~   "
95754|NCT01803802|"~     This study is designed to help us better understand the factors that affect the sexual lives~     of women who have been sexually mistreated during childhood. With this study we hope to~     learn about factors that may be promising targets for future treatments of sexual problems~     related to past sexual experiences. The investigators hypothesize that women who have~     experienced early sexual abuse are more likely to have sexual problems in adulthood than~     women who were not abuse in childhood.~   "
95755|NCT01803789|"~     Metacarpal V fractures are injuries of the upper extremities. They occur frequently,~     primarily in young adults.These fractures are caused by falling on the fist, sports~     accidents and direct or indirect forces.~      Surgical intervention is necessary for fractures with a strong palmar angulation of the~     metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline~     recommendations decisions about therapy are made taking into account logistical aspects,~     available hardware, individual expertise and preferences. The objective of the study is to~     compare the advantages and disadvantages of single versus double Kirschner wires for~     intramedullary fixation of metacarpal V fractures in order to standardize national therapy~     procedures.~      Primary hypothesis:~      In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck~     fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with~     a double Kirschner wire with regard to the functional outcome after 6 month, as measured~     with the Disabilities of the Arm, Shoulder and Hands Score (DASH).~   "
95756|NCT01803776|"~     The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre physical~     activity and diet intervention study that provides novel scientific information on physical~     activity, nutrition, overweight, obesity, physical fitness, cognition, oral health, sleep,~     pain and other aspects of quality of life as well as health care costs in a population~     sample of children and adolescents. The main hypothesis of the study is that regular~     physical activity and dietary changes improve health and quality of life among children and~     adolescents.~   "
95757|NCT01803763|"~     The aim of this study is to investigate the pathophysiological mechanism of omalizumab in~     patients with documented chronic urticaria who have complaints under standard antihistamine~     treatment. With this study the investigators will assess the correlation between Fc-IgE~     receptor downregulation as well as functionality and clinical response to omalizumab~     treatment in patients with chronic urticaria. This may be an approach for other diseases as~     well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a~     total of 4 monthly applications of omalizumab. According to the dosage recommendations of~     recent studies, fixed doses of 300 mg omalizumab are administered subcutaneously.~   "
95758|NCT01803750|"~     The purpose of this study is to understand primary care provider's knowledge, attitudes, and~     barriers to promoting evidence-based cancer screening and prevention practices for~     physicians with large Latino patient populations. The investigators will ask providers~     information on cancer screening and prevention practices by conducting one-on-one~     interviews. In addition, they would like to develop a committee of community providers to~     help design and implement cancer screening and prevention programs specifically for Latino~     patients based on the interview findings.~   "
95759|NCT01803737|"~     The purpose of this study is to examine the feasibility of a campaign intervention for~     weight management compared to a standard behavioral weight loss intervention in overweight~     and obese adults.~   "
95804|NCT01803139|"~     Women diagnosed with an early stage cancer of the breast usually have the cancer removed by~     lumpectomy and then have radiation treatments to the entire breast. In 2008 the~     investigators published the result of a multicentre study showing that breast Intensity~     Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns.~     In this study the investigators will recall all patients at 8 years to assess if this~     technique also reduces permanent side effects including pain and cosmesis.~   "
95760|NCT01803724|"~     The Irritable Bowel Syndrome (IBS) is a frequent disease, affecting between 10 and 20% of~     general population. Several pathophysiologic mechanisms have been described in IBS, among~     them the role of intestinal microbiota and small intestinal bacterial overgrowth (SIBO) have~     received special attention. SIBO has an adequate response to antibiotic treatment,~     unfortunately it didn't have an adequate diagnostic test: The classic gold standard -jejunal~     aspirate culture- has been criticized due to lack of standardization; the breath tests are~     simpler and widely available, but they have also been criticized due to inadequate~     diagnostic accuracy for SIBO. For this reason seems important to evaluate the performance of~     breath tests in terms of predicting clinical benefit of antibiotic therapy in IBS patients,~     rather than predicting a positive culture and SIBO.~      The objectives of this study are:~        1. Determine which breath test (lactulose or glucose) predicts better a potential clinical~          benefit of antibiotic treatment (Rifaximin) in IBS patients.~        2. Determine which of the multiples diagnostic criteria described for the lactulose breath~          test predicts better a potential clinical benefit Rifaximin in IBS patients.~   "
95761|NCT01803711|"~     To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine~     (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety~     symptoms in patients with select medical conditions (cancer, cardiovascular diseases and~     diabetes).~   "
95762|NCT01803698|"~     Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal~     gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for~     optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout~     the duration of a pregnancy. Although there is a significant association between the total~     GWG recommended by these guidelines and maternal and perinatal outcomes, research has~     demonstrated that only approximately one-third of pregnant women have total GWG within the~     recommended amounts. Factors known to influence GWG include maternal age, parity, being in a~     committed relationship and smoking. In addition, recommendations by primary care providers~     have been shown to influence actual GWG. Women appreciate advice from their primary care~     providers, however, despite this, there is evidence that many patients report not being~     advised at all about GWG by their primary care providers.~      Relevance Excess weight gain in pregnancy has been shown to be a modifiable risk factor for~     excess weight in childhood, thus contributing to the intergenerational cycle of obesity.~     There is an opportunity to interfere with this cycle during the peri-pregnancy period, as~     women's motivation to engage in behaviour change is elevated and contact with their primary~     care providers is frequent.~      Research Question and Hypothesis What impact does training family physicians to regularly~     refer to the IOM trajectories and provide feedback about GWG (training in the use of IOM~     charts) during routine prenatal visits, compared to usual care, have on congruence of total~     GWG with IOM guidelines? Null Hypothesis: there is no difference in the congruence of total~     GWG with IOM guidelines between women whose family physicians were assigned to training in~     the use of the IOM charts and those whose family physicians were assigned to usual care.~      Objectives~      The following are the objectives for this study:~        1. To compare the congruence of total GWG with IOM guidelines between women whose family~          physicians were assigned to training in the use of IOM trajectories and those whose~          family physicians were assigned to usual care.~        2. To explore the relationship between other independent variables (maternal age, parity,~          committed relationship and smoking) and congruence of total GWG with IOM guidelines,~          for women whose family physicians were assigned to training in the use of IOM~          trajectories and for those whose family physicians were assigned to usual care.~   "
95763|NCT01803685|"~     This register study will collect the treatment information of the intracranial arteriovenous~     malformation patients in China. We aim to understand the current treatment situation of the~     disease in China.~   "
95764|NCT01803672|"~     Background.There is some evidence that engaging in regular moderate-intensity physical~     activity may help ameliorate cancer-related fatigue experienced by childhood cancer~     survivors, which eventually improve their quality of life. Nevertheless, there is growing~     concern about declining levels of physical activity in childhood cancer survivors.~      Purposes. To examine the effectiveness of an integrated adventure-based training and health~     education programme in promoting the adoption and maintenance of regular physical activity,~     reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer~     survivors.~      Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated~     post-test, between subjects design was conducted. Recruitment of subjects was carried out~     through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim~     to provide education and psychological support to parents of Hong Kong Chinese childhood~     cancer survivors.~      Intervention. Participants in the placebo control group received an amount of time and~     attention (leisure activities organized by a community centre) that mimicked that received~     by the experimental group. Participants in the experimental group joined a four-day~     integrated adventure-based training and health education programme, which contained~     education talks, a workshop and adventure-based training activities.~   "
95765|NCT01803659|"~     The purpose of this pilot study is to determine whether breast milk retinol concentration~     increases in response to daily supplementation with small amounts of vitamin A (~600 ug~     RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary~     purpose is to evaluate sampling methods for collecting breast milk samples in a community~     setting. The results of this pilot study will allow us to determine whether milk retinol is~     a useful indicator for evaluating the impact of food-based interventions on the vitamin A~     status of lactating women.~   "
95766|NCT01803646|"~     The purpose of this research study is to test the safety and effectiveness of the study~     drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of~     an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with~     tinnitus can take part in the study, if their tinnitus started within the last 3 months.~   "
95767|NCT01803633|"~     Phase 2 of this study involves determining how consumption of cheese compared with a~     non-dairy cheese substitute influences inflammation over a six hour period.~   "
95768|NCT01803607|"~     The purpose of this study is to assess to what extent sequential treatment with odanacatib~     results in incremental gains in bone mineral density (BMD) over time in female participants~     who have received at least 3 years of bisphosphonate therapy.~   "
95769|NCT01803594|"~     This study involves measuring subject's blood lipid responses after they consume a mixture~     of dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake,~     on three separate days. The investigators hope to learn more about how different food~     ingredients influence the metabolism HDL in individuals with low blood levels of HDL~     cholesterol.~   "
95770|NCT01803581|"~     The purpose of this study is to compare the efficacy and safety of an insecticide-free head~     lice product with that of a pyrethrum-based product.~   "
95805|NCT01803126|"~     Biofilm has been identified as the major bacterial phenotype contributing to~     atherosclerosis. It has become very important to evaluate atherosclerosis and the role of~     biofilm using advanced technologies. It is also important to understand wound biofilm at a~     genetic and a molecular level.~   "
95806|NCT01803113|"~     The objective of this field study is to demonstrate the clinical performance of the Sofia~     hCG FIA Test, using urine specimens from females of childbearing age.~   "
95771|NCT01803568|"~     Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose~     within normal range and hence, insulin resistance (possibly mediated by inflammatory~     processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical~     activity seems to be of essential importance in the prevention and treatment of type 2~     diabetes. Myokines are proteins secreted from skeletal muscle that can execute important~     biological functions locally in the muscle (paracrine) or in other organs like the brain,~     heart and pancreas (endocrine). Evidence suggest that several interleukines and other~     cytokines are secreted by skeletal muscles. In the present project, the investigators will~     explore the relation between secreted myokines from muscle cells, insulin resistance and~     glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal~     as well as impaired glucose metabolism will be included in the study.~   "
95772|NCT01803555|"~     The primary objective of the study is to establish whether budesonide/formoterol fumarate~     dihydrate (BF) SPIROMAX 160/4.5 mcg is as effective as SYMBICORT TURBOHALER 200/6 mcg~     administered twice daily in patients with persistent asthma.~   "
95773|NCT01803542|"~     The purpose of this institutional protocol is to offer SBRT to selected patients in a~     controlled environment to refine treatment techniques (including dose/fractionation~     schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in~     some institutions and the available data suggest that it can be used safely and with good~     results. This study will see how effective Stereotactic Body Radiation Therapy is for~     treating tumours in the lung and how often people have side effects. Radiation therapy is~     usually given once a day, often for a few weeks. In this study, study participants will~     receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment~     sessions over a total of about 1 to 2 weeks.~      Several reports indicate that this therapy might shrink tumours and control the cancer for~     extended periods of time. Although specialists started to treat patients with SBRT over 10~     years ago, it is still used in relatively few cancer centres.~   "
95774|NCT01803529|"~     Studies show that chest pain is a common complaint presented in both general practice and in~     emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies~     about treatment of chest pain from the intercostal muscles were found by search in medical~     literature databases. The purpose of this study is to evaluate the effect of two different~     physical therapy interventions on intercostal pain in patients with stable heart disease.~      The hypothesis was that deep friction massage combined with heat-pack is more effective than~     heat-pack only.~   "
95775|NCT01803516|"~     The purpose of this study is to see how the look of telangiectasias (small dilated blood~     vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's~     overall well being.~      Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets~     red blood vessels and delivers heat causing the telangiectasias to become smaller and less~     visible. The laser has been used safely to treat telangiectasias on the skin of patients who~     received radiation for breast cancer.~      Patients in the study will be asked to complete a questionnaire asking how they feel about~     the telangiectasias, their radiated skin and its effect on their daily lives. The~     questionnaire will be given at every visit. The improvement in the look of patients'~     radiated skin will also be compared to answers to the questionnaire. We hope the study will~     improve our understanding of how patients feel about the long term effects of radiation on~     their skin.~   "
95776|NCT01803503|"~     This study aims to find out whether the effect of docetaxel chemotherapy may be improved by~     combining it with another anti-cancer drug called sunitinib, which stops blood vessels from~     growing (anti-angiogenic agent). Sunitinib is an oral anti-angiogenic drug that has been~     approved for the treatment of kidney cancer, a rare form of soft tissue tumor called~     gastrointestinal stromal tumor, and a rare form of cancer in the pancreas called pancreatic~     neuroendocrine tumor. Sunitinib is usually given continuously at a dose of 37.5mg (3 pills)~     daily either alone or in combination with chemotherapy. However, there are studies which~     have shown that the continuous administration of sunitinib may reduce chemotherapy~     effectiveness. On the other hand, a short course of sunitinib before each chemotherapy cycle~     may sensitize the tumor to chemotherapy. This treatment strategy will be used in patients~     with different kinds of cancers with a commonly used chemotherapy drug, docetaxel. Ths study~     aims to evaluate if intermittent administration of low dose sunitinib before docetaxel~     chemotherapy can improve the treatment response in cancer patients.~      Study Hypothesis: Low dose, short course sunitinib at 12.5mg daily orally for 1 week prior~     to chemotherapy can normalize tumor vasculature and enhance delivery of chemotherapy into~     the tumor, and improve treatment response and progression-free survival.~   "
95777|NCT01803490|"~     Closed suction drains are commonly used following surgery, if the wound is expected to~     discharge significant amounts of fluid. To this date, no evidence base exists as to the~     exact post operative time period or discharge volume necessitating presence of a drain. In~     orthopedic common practice, drains are removed on the second post operative day, fearing the~     drain will serve as a point of entry for nosocomial infection. In this study, drains will be~     left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of~     days following surgery. Daily cultures and antibiotic levels will be taken from the drains~     receptacle, to determine if and when the drains is colonized by aerobic bacteria.~   "
95778|NCT01803477|"~     The purpose of this study is to determine if the new vehicle formulations containing ingenol~     mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation)~     when applied to AK lesions on the forearm for two consecutive days.~   "
95779|NCT01803464|"~     Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000~     individuals in the U.S. An estimated 70-80% of these individuals have spasticity which~     affects ambulation and requires management. Therefore, the treatment of spasticity is a~     primary goal of interventions for children with CP. One treatment widely used to reduce~     spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no~     studies have determined the effect of Botox treatment on bone in humans. Also, a low~     intensity vibration treatment has been shown to improve bone structure in the lower~     extremity bones of children with CP. The aims of this study are: 1) to determine the effect~     of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone~     structure in children with spastic CP, and 2) to identify the mechanism that underlies the~     effect of Botox and vibration on bone.~   "
95780|NCT01803451|"~     The overall goal of this project is to understand the mechanisms by which gastric bypass~     surgery improves glucose metabolism.~      The central hypothesis guiding this project is that the reconfiguration of intestinal~     transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed~     incretins that improve insulin secretion and glucose metabolism. The study is divided into~     three specific aims.~        1. To determine the role of incretin hormones on insulin secretion in patients with~          gastric bypass surgery using intravenous-oral hyperglycemic clamp.~        2. To compare incretin effect and glucose tolerance among patient who suffer from~          hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.~        3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.~   "
95781|NCT01803438|"~     The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI)~     performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line~     therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial~     fibrillation (AF).~   "
95782|NCT01803425|"~     This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy~     infants and children of the local population as per the licensing requirement of the Sri~     Lankan regulatory authority.~   "
95783|NCT01803412|"~     This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects~     with DMD open to eligible US and Canadian subjects who previously participated in the~     following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive~     6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously~     experienced significant safety or tolerability issues or who experience these during the~     study, there is the potential of an alternate intermittent dosing arm that will be given as~     a regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who~     experience or have previously experienced significant safety/tolerability issues, side~     effects or reactions or intermittent dosing, intravenous dosing will be made available.~   "
95784|NCT01803399|"~     This is a randomized, partially-blinded, placebo and moxifloxacin-controlled, single dose,~     4-period, balanced crossover study. The primary objective of this study is to separately~     assess the effects of a therapeutic and supratherapeutic dose of GSK1322322 on the cardiac~     conduction (corrected QT interval [QTc]) compared with placebo in eligible healthy male and~     female subjects. Avelox (moxifloxacin hydrochloride) will be used as an open-label positive~     control in order to validate the sensitivity of the study in detecting QTc change.~     Approximately 56 healthy subjects will participate in the study for approximately 9 weeks~     i.e. 30 day Screening period, 4-week Treatment period, and a 7-10 day Follow-up period.~     There will be 4 treatment periods separated by at least 1 week. Subjects will be admitted to~     the clinical unit on Day -1 of each dosing period. Each subject will receive each of the~     four treatment sequences (GSK1322322 1200 milligram [mg] intravenous [IV] over 60 minutes x~     1 dose, GSK1322322 3000 mg IV over 60 minutes x 1 dose, GSK1322322 Placebo IV over 60~     minutes x 1 dose, moxifloxacin 400 mg administered orally x 1 dose) on Day 1 of each~     Treatment period in a randomized fashion. Twelve-lead electrocardiogram (ECG), continuous~     Holter monitoring, laboratory tests, vital sign measurements, and serial pharmacokinetic~     samples will be collected for up to 24 hours following each treatment. If no clinically~     significant abnormalities are noted, subjects will be discharged from the clinical research~     unit after the completion of all assessments on Day 2 in each period and return~     approximately one week later for the next dosing period. Each individual subject will follow~     the same dosing schedule at every period. A Follow-up visit will be conducted 7-10 days~     after administration of the last dose of study medication in treatment period 4.~   "
95785|NCT01803386|"~     The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device~     and study its reliability and ability to differentiate ALS patients from healthy controls.~   "
95786|NCT01803373|"~     The purpose of this study is to test the relative bioavailability (extent and rate to which~     a drug is taken up by the body) of TMC207 following the administration of two pediatric~     formulations of TMC207 taken with and without food in healthy adult participants.~   "
95787|NCT01803360|"~     The purpose of this study is to determine whether neridronate is effective in the treatment~     of pain related to bone marrow oedema in patients with osteoarthritis of the knee.~   "
95788|NCT01803347|"~     Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery~   "
95789|NCT01803334|"~     This is a study looking at patient's satisfaction with incision site and location after~     undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have~     the anticipated incision marked with a washable marker on their abdomen. The control group~     will have preoperative counselling as usual. After surgery, will assess patient's~     satisfaction with the incision scar.~   "
95790|NCT01803321|"~     This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo~     controlled, pediatric study conducted in three phases.~   "
95791|NCT01803308|"~     The purpose of this study is to compare the safety and tolerability of ascending doses of SB~     9200 given for up to 14 days to subjects with chronic Hepatitis C infection.~   "
95792|NCT01803295|"~     In the proposed study the investigators aim to evaluate the effect of the standard of care~     dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low~     risk recurrent NMIBC lesions and to compare our findings to instillation with the standard~     mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed~     with TC-3 gel will have at least non-inferior and even superior results over the standard~     instillation mode~      The investigators believe that this study is of importance of several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. If proved effective this mode of treatment might save the need of TURBT performance and~          serve as a new mode of tumor ablation.~        3. Even if proved partially effective this mode of treatment will diminish tumors size or~          number thus enable a more limited TURBT procedure.~        4. This mode of treatment will enable immediate medical attendance to the patient's tumor~          recurrence without the waiting period (resulting from queues in the medical centers)~          for TURBT, which might improve the patient's prognostic outcome.~        5. If this experimental treatment will prove to have a better ablative effect, this could~          be translated to a better prophylactic effect of tumor recurrence.~   "
95818|NCT01802957|"~     This study will introduce a multi-faceted intervention package which will be implemented in~     the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and~     the surrounding seven satellite health centers. The goal is to assess if this group of~     interventions improve the skills and confidence of providers to handle obstetric~     emergencies, if they streamline the referral process and if they result in improved~     maternal/newborn health outcomes.~   "
95793|NCT01803282|"~     This is an open-label, multicenter, sequential dose-escalation, and expansion study to~     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GS-5745 alone~     and in combination with chemotherapy.~      The study consists of 2 parts (Parts A and B). Participants can only qualify for and~     participate in 1 part.~      Part A is a sequential dose escalation to determine the maximum tolerated dose of GS-5745 in~     participants with advanced solid tumors that are refractory to or intolerant to standard~     therapy or for which no standard therapy exists. In Part A, participants will receive~     GS-5745 only. Part A will consist of between 12 to 48 participants.~      Part B is a dose expansion to obtain additional safety and tolerability data for GS-5745 in~     participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous~     cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part~     B, participants will receive GS-5745 in combination with standard-of-care chemotherapy. Part~     B will consist of between 115 to 295 participants.~      Please note the study is currently only recruiting in the colorectal and breast cancer~     cohorts.~   "
95794|NCT01803269|"~     This randomized phase II trial studies how well giving topotecan hydrochloride or~     cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent~     small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know~     whether topotecan hydrochloride is more effective than cyclodextrin-based~     polymer-camptothecin CRLX101 in treating patients with lung cancer.~   "
95795|NCT01803256|"~     The full body marker sets that are typically used in opto-electronic 3D gait analyses either~     disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of~     this study is to identify the possibilities and limitations of an enhanced trunk marker set~     for the measurement of spine dynamics during gait in adolescents with and without structural~     spine deformities.~      It has been hypothesized that the enhance trunk marker set:~        1. is a valid method for the measurement of spine deformations in the sagittal, frontal~          and indirectly transverse planes.~        2. is an applicable and reliable method for the measurement of spine dynamics during gait~          in healthy adolescents and in patients with structural deformities such as seen in~          scoliosis.~        3. is sensitive enough to distinguish the spinal movement pattern during gait measured in~          scoliosis patients from the one measured in healthy adolescents.~      To verify the hypotheses, the following measurements will be carried out:~        -  Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.~        -  Instrumented gait analysis with a standard full body marker set and the enhanced trunk~          marker set in scoliosis patients and healthy controls.~   "
95796|NCT01803243|"~     Measuring spine dynamics is a necessity in order to better understand gait deviations~     throughout the whole body and to evaluate treatment effects on spinal movement during gait.~     However, the full body marker sets that are typically used in opto-electronic 3D gait~     analyses either disregard the spine entirely or regard it as a rigid structure. Therefore,~     the purpose of this study is to use an enhanced trunk marker set in order to evaluate the~     biomechanical effects of lower extremity treatments on spine dynamics in patients with~     different pathologies.~      It has been hypothesized that~        1. the enhanced trunk marker set is a reliable method for the measurement of spine~          dynamics during gait in patients with deviations occurring secondary to leg length~          inequality.~        2. the enhanced trunk marker set is a reliable method for the measurement of spine~          dynamics during gait in patients that present both primary and secondary deviations~          such as seen in hemiplegic and diplegic cerebral palsy.~        3. treatment by means of either a shoe insole or a modified shoe with sole lift on the~          shorter side has an effect on spine dynamics during gait in patients with leg length~          inequality.~        4. treatment by means of an ankle foot orthosis to control the foot position has an effect~          on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.~      To verify the hypotheses, instrumented gait analyses with a standard full body marker set~     and the enhanced trunk marker set will be carried out before and immediately after an~     orthotic lower extremity treatment in the respective patient group.~   "
95797|NCT01803230|"~     Creatine supplementation may improve cognitive function in elderly and vegetarian~     individuals. This study aims to investigate the role of creatine supplementation on~     cognitive function in healthy children.~   "
95798|NCT01803217|"~     Unnecessary right ventricular pacing has been shown to be detrimental in recipients of~     implantable pacemaker or defibrillators.~      The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms~     (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right~     ventricular pacing.~   "
95799|NCT01803204|"~     To evaluate the effectiveness in the use of an educational material through: Assessment of~     knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the~     survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management~     of postoperative signs and symptoms~   "
95800|NCT01803191|"~     The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic~     bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of~     fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose~     of ciprofloxacin 500 mg 1 hour before biopsy.~   "
95801|NCT01803178|"~     The main aim of the study is to investigate, in humans, the effect of plant sterols on~     vascular function by measuring flow-mediated dilation (FMD).~      This study also aims to study the effect of plant sterols on pulse wave velocity (PWV),~     aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP),~     blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on~     z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation~     will be assessed.~      For all study outcomes, effect sizes and 95% confidence intervals will be estimated.~      Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly~     increase FMD.~   "
95829|NCT01802814|"~     The main goal of this study is to improve the outcome of children and adolescents with~     standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a~     large international study group platform allowing for optimization of standard treatment~     strategies and integration of new agents.~   "
95807|NCT01803100|"~     Overall Aim: To describe and to assess the change in the temporal profile and transmission~     of microorganisms between patients and environmental surfaces after admission into a newly~     disinfected room.~      Study Activities: Investigators will prospectively and concurrently perform microbiological~     sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces~     (e.g. bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult~     patients admitted to freshly cleaned patient rooms. The microbiological sampling of body~     sites is already performed in many units of the hospital as standard of care. Infection and~     readmission related data from enrolled patients will be collected for upto 1 year after~     enrollment.~      Data analysis: Standard surveillance for hospital-acquired infections will be performed by~     the infection control group of the hospital. The identity and the nature of micro-organisms~     colonizing the high touch surfaces of rooms and of patient's body sites will be determined~     and compared. Risks involved is no more than minimal risk.~   "
95808|NCT01803087|"~     This clinical pharmacology want to investigate the systemic availability of BDP/B17MP~     (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6~     pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free~     combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally~     compared to the systemic exposure in adults without the spacer device.~   "
95809|NCT01803074|"~     The primary purpose of this study is to study the safety and tolerability of a HIV drug and~     to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected~     patients~   "
95810|NCT01803061|"~     Patient-reported information on outcomes such as symptom-burden and health-related quality~     of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer~     research. However, integrating patient-reported information in the routine clinical practice~     is often difficult due to excessive time use and practical barriers. Electronic data~     acquisitions, where the treating physician has immediately access to the patient-reported~     data in the subsequent consultation, have been shown to be beneficial in the everyday~     clinical decision making.~      The aim of this study is to develop and test a computer-based patient-reported assessment~     tool that will assist the clinicians in tracking long term and late effects in head and neck~     cancer patients and investigate if the tool leads to improved symptom assessment of a range~     of head and neck cancer specific symptoms, which again may lead to improved symptom control~     and enhanced quality of life in the patients.~      Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics~     at Herlev Hospital and physicians and nurses who work at the clinic will be invited to~     participate. The assessment tool will be developed with inspiration from prior international~     studies of symptom assessment in head and neck cancer patients and tailored so that it will~     fit into a Danish context. The tool will be tested in a controlled intervention study. In~     the intervention group, patients will complete the assessment tool in the patients waiting~     area prior to every scheduled consultation. The result will then be printed and provided to~     the treating physician. In the control group, the patients will complete the assessment tool~     prior to consultations. However, the data will not be provided to the physicians at any~     time.~      To assess the impact of the tool on number of symptoms addressed during consultations and~     patients' overall quality of life, medical records will be reviewed for before start of~     intervention and again at 6 and 12 months follow-up. The patients will also complete the~     EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up.~     Furthermore, we will conduct a qualitative evaluation (semi structured interview and~     participant observations) of attitudes among clinicians and patients regarding the use of~     tool at the point of care.~   "
95811|NCT01803048|"~     Abnormalities in structural and functional connectivity between brain regions have been~     suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant~     contributors to neuropsychological functioning and injury outcome. The purpose of this study~     is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted~     imaging (DWI) and resting state functional MRI to compare structural and functional~     connectivity between individuals with documented mild TBI and healthy controls. To evaluate~     the significance of structural and functional connectivity for behavior, the brain imaging~     data will then be related to measures of cognition and emotion. Over a 4-year period, 150~     adults with documented mild TBI and 30 healthy controls will participate in the study.~      The study will investigate the following questions and hypotheses:~        1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter~          integrity across multiple stages of recovery following mild TBI relative to healthy~          controls. It is hypothesized that mild TBI will be associated with greater white matter~          abnormalities than healthy controls.~        2. It is hypothesized that there will be a relationship between FA, cognition and emotion~          as a function of the injury.~        3. It is hypothesized that functional connectivity will be related to FA.~   "
95812|NCT01803035|"~     The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in~     terms of clinical and microbiological response in treatment of impetigo.~   "
95813|NCT01803022|"~     The study purpose is to document the prescription and the use of Low Molecular Weight~     Heparin in usual medical practice in patients with cancer and established Venous~     Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular~     Weight Heparin therapy of Venous Thromboembolism in patients with cancer.~   "
95814|NCT01803009|"~     Little is known about the impact of risk assessment tools on decision-making by patients and~     clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one~     of the most prominent risk assessment tools available, no study has quantified its usability~     or impact on decision-making or uptake of screening. In this study, we will measure~     patients' satisfaction with the NCI CRC RAT, their perception of its usability and~     helpfulness, and its impact on their decision-making and behavior. In addition, we will~     assess the impact of adding information about their chance of having an advanced adenoma.~   "
95815|NCT01802996|"~     This purpose of this study is to evaluate the evaluate the efficacy of Magnesium~     Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute~     liver injury.~   "
95816|NCT01802983|"~     The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to~     prolongation of intensive and mortality. It is reported that the mortality rates have varied~     between 20% and 100%, depending on number, severity, duration, type and combination, and~     definition of dysfunction. In our study, the investigators explore some comprehensive~     treatment technology to improved outcomes of MODS patients.~   "
95817|NCT01802970|"~     To determine the safety of administering anakinra plus the physician's chemotherapy choice~     (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic~     breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in~     patients who undergo IL-1 receptor blockade.~   "
95830|NCT01802801|"~     The purpose of this study is to determine the intra- and interobserver agreement.~   "
95831|NCT01802788|"~     Further assess the performance and safety profile of the commercially available Portico~     Valve implanted, using the Delivery System and the Loading System, in patients with severe~     symptomatic aortic stenosis.~   "
95819|NCT01802944|"~     Following their deployment to the 1991 Gulf War, many veterans (GWV) reported a~     constellation of unexplained health symptoms; common among them were attention and memory~     difficulties, fatigue, joint pain, headaches, gastrointestinal complaints, and mood and~     sleep problems. Despite the passage of time, the symptom complex persists for many veterans.~     Indeed, it is estimated that at least 25 percent of GWV (nearly 170,000 veterans) have a~     persistent form of chronic multisymptom illness (CMI). GW deployed veterans are also~     developing significantly more chronic diseases such as diabetes, hypertension, arthritis,~     and coronary heart disease than their non-deployed veteran peers putting these individuals~     at risk for accelerated aging-related diseases of the peripheral and central nervous system~     (CNS). Recent studies have shown a slowing of response speed that affects mental flexibility~     across multiple cognitive domains (memory, attention, visuospatial functions) especially on~     tests that were timed and computerized and where small differences in cognitive reaction~     times could be measured. Recent studies also have suggested that the response inhibition~     deficits shown in GWV may reflect executive system dysfunction as reflected by slower motor~     responses across multiple cognitive domains.~      To date, there are no treatments that have been shown to improve the health or cognitive~     difficulties of GW veterans; thus there is an urgent need to establish effective, safe, and~     tolerable treatments for GW CMI. Previous studies in other cognitive disorders have found~     that intranasal insulin improves memory, attention, and mood, reduces neuroinflammation, and~     modulates cortisol levels; it has also been identified as a treatment that has the capacity~     to alter many of the leading problems of GW CMI.~      During this study there are 2 treatment groups and a placebo group that will last for 8~     weeks. The treatment groups will self-administer their designated dosage of insulin through~     a nasal pump twice a day, while the placebo group will administer saline through a nasal~     pump twice a day. These doses have been shown to be effective and safe. The primary outcome~     measure will assess improvements in verbal delayed memory using a specific list learning~     task and on a measure of selective attention. The study will assess improvements in overall~     physical health and mood by asking the participants to complete self report questionnaires.~     Neuroendocrine measures will also be obtained in order to evaluate changes in glucose,~     insulin, and cortisol levels and examine their impact on GW CMI.~      Intranasal insulin has shown great promise in improving memory, attention, and mood in both~     older adults with cognitive impairment as well as normal subjects. Thus, this proposal could~     prove intranasal insulin to be an effective, safe, and affordable therapy for these ailing~     veterans.~   "
95820|NCT01802931|"~     The study will determine the effect of 400 mg once daily of ketoconazole at steady state on~     the pharmacokinetics of a single oral dose of GSK239512 in young healthy volunteers.~     Ketoconazole is a strong inhibitor of CYP3A4, which is involved in metabolism of drugs. A~     two-cohort design will be applied with cohort 1 aimed at providing a first estimate of the~     interaction potential of GSK239512 and ketoconazole in terms of pharmacokinetic parameters~     in a small number of subjects. Data from Cohort 1 will inform the decision of which dose to~     use in Cohort 2, in which a larger number of subjects will be exposed to GSK239512 without~     and with ketoconazole. The target maximum exposure is aimed to be similar to the exposure by~     a single dose of 80 mcg of GSK239512 without CYP3A4 inhibition. In summary, the results from~     this study will help to estimate the maximum increase in exposure of GSK239512 during~     concomitant use of strong CYP3A4 inhibitors and will help define the subsequent dosing~     strategy around GSK239512 and co-medications with potential to inhibit CYP3A4.~   "
95821|NCT01802918|"~     GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the~     treatment of chronic HIV infection. This study is the first administration of GSK2838232 in~     humans to establish the initial safety, tolerability, and pharmacokinetic profile following~     single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on~     GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1,~     approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose~     visit. There will be four dosing sessions for each subject with subjects randomized to~     receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be~     enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four~     dosing sessions for each subject with subjects randomized to receive placebo in a random~     sequence.~   "
95822|NCT01802905|"~     Most systemic therapies are chosen on the basis of large randomized clinical trials;~     however, tumour heterogeneity means that cancers with similar histological features may have~     substantially different underlying biological drivers. The investigators propose that~     applying personal genomic information prospectively obtained in a clinically realistic~     timeframe to assist in chemotherapy decision-making could result in more effective and~     efficient cancer treatment. This study will investigate this approach in a cross section of~     advanced cancers to examine timeliness, deliverability, rate of actionable targets~     identified, and our ability to expand this approach into a larger clinical trial setting.~   "
95823|NCT01802892|"~     The present study aims to evaluate the impact of 5 days oral administration of ronacaleret~     100 miligram (mg) and 400 mg on changes in circulating CD34+ cells, when ronacaleret is~     followed by the administration of a single dose of plerixafor in healthy human volunteers.~      This single centre adaptive design study will be carried out in 2 parts. The part A will~     evaluate the change in peripheral circulating CD34+ cells in response to two different 5 day~     regimens of ronacaleret (100 mg or 400 mg once daily), given in conjunction with a single~     dose of plerixafor (0.24 mg/kilogram [kg]) sub-cutaneously (SC) on the evening of the final~     days dosing approximately 12 hours before collection of CD34+ cells on day 6. Subjects (5~     each) will be assigned to either one of the ronacaleret arms, in an open fashion.~     Comparisons will be made in the change from baseline to end of treatment peripheral CD34+~     cell counts. Part A will be conducted in two cohorts with 5 subjects being enrolled into~     each of the 2 treatment arms making up the first cohort. Cohort 2 will involve up to 5~     further subjects being enrolled into each treatment arm.~      The structure of part B will be finalized following a review of data generated in part A.~      The total study duration of Part A for each subject including the screening, treatment and~     follow-up periods will be approximately 7 weeks.~   "
95824|NCT01802879|"~     The study allows continued use of single agent panobinostat in patients who are on single~     agent panobinostat treatment in a Novartis-sponsored study which has met its endpoint and~     are benefiting from the treatment as judged by the investigator.~   "
95825|NCT01802866|"~     The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the~     rate of progression of geographic atrophy compared to placebo in subjects with dry~     age-related macular degeneration.~   "
95826|NCT01802853|"~     This open-label, randomized, 2-way crossover study will assess the absolute bioavailability~     and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to~     one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B)~     RO6811135, with a washout period of at least 7 days between dosing.~   "
95827|NCT01802840|"~     The aim of this study is to examine the effects of soy fiber on body weight, body~     composition and blood lipids in overweight and obese participants.~   "
95828|NCT01802827|"~     To investigate the clinical course and risk factors for VAT and the impact of VAT on~     Intensive Care Unit (ICU) morbidity and mortality.~   "
95834|NCT01802749|"~     Bevacizumab has been found to prolong progression free survival in first line, and more~     recently, in second line treatment for platinum sensitive ovarian cancer patients who had~     not received prior treatment with bevacizumab.~      Recently reported data suggest that patients with colon cancer who receive bevacizumab in~     more than one line of therapy (beyond progression) have better results. In ovarian cancer,~     the role of bevacizumab administered in both first and second-line therapies needs to be~     defined.~      This study aims to evaluate whether administering bevacizumab in combination with~     chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have~     received first-line bevacizumab will be more effective than chemotherapy alone.~   "
95835|NCT01802736|"~     Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and~     transmitted mainly through sexual intercourse between an HIV infected and uninfected person.~     Uganda is ranked among 28 top per capita alcohol consumers in the world and second in~     Africa. in the general population, Alcohol consumption is associated with increased sexual~     transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors~     and HIV disease progression among HIV infected persons, the persons able to transmit HIV are~     lacking in this setting.~      Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons,~     assess associations between alcohol and CD4 cell count as well as evaluate the effect of~     alcohol motivational intervention counseling on alcohol consumption and the subsequent~     practice of risky sexual behaviors, among HIV infected persons.~      Methodology: Using both cross-sectional and longitudinal methods,persons living with~     HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be~     recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol~     consumption will be randomized to receive either Standard positive prevention counseling~     alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors~     and alcohol consumption will be evaluated at 3 and 6 months and compared between~     randomization arms.~   "
95836|NCT01802723|"~     Dose Ranging Study~   "
95837|NCT01802710|"~     Functional dyspepsia (FD)is defined as the presence of symptoms thought to originate in the~     gastroduodenal region with no evidence of structural disease that is likely to explain the~     symptoms. The cause of this condition is unclear, not being a recognized treatment for it.~     The conventional treatments for those patients are symptom based. Unfortunately, these~     medications are not very effective. Patients with FD report poorer health status, mental~     health, and social functioning than patients with structural gastrointestinal pathology. Our~     aim is to compare a combined intervention (medical plus psychological intervention) versus~     conventional intervention (medical intervention)in regard to the health related quality of~     life, symptomatology, anxiety and depression of those patients. The investigators~     hypothesized that compared with conventional intervention a combined intervention would~     yield significantly better short (after treatment) and medium term (six months after~     treatment) improvement of health related quality of life and symptoms.~   "
95838|NCT01802697|"~     This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme~     Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).~   "
95839|NCT01802684|"~     Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than~     a continuous administration of chemotherapy until progression, in order to decrease the risk~     of severe toxicities.~   "
95840|NCT01802671|"~     The objective of this study is to investigate the short- and long-term efficacy of a~     Cognitive Behavioural Treatment program for chronic low back pain supported by information~     and communication technologies~   "
95841|NCT01802658|"~     Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time~     to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.~      Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion~     of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and~     architectural disorganization. These phenomena occur in the first weeks of development of~     spinal cord injury and predominate in the distal femur and proximal tibia. From the third~     year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of~     the initial bone mass, the new equilibrium.~      No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to~     assess this risk. There is an association between bone mineral density and fracture risk.~     The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density~     in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy~     to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.~   "
95842|NCT01802645|"~     The aim of this study is to investigate the following schedules for efficacy with regard to~     response rate in neoadjuvant treatment of patients with non-resectable liver metastases:~        -  Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and~        -  Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.~   "
95843|NCT01802632|"~     This study will treat patients with advanced NSCLC who have already received at least one~     course of specific anti-cancer treatment but the tumour has started to re-grow following~     that treatment. This is the first time this drug has ever been tested in patients, and so it~     will help to understand what type of side effects may occur with the drug treatment, it will~     measure the levels of drug in the body, it will also measure the anti-cancer activity. By~     using these pieces of information together the best dose of this drug to use in further~     clinical trials will be selected.~   "
95844|NCT01802619|"~     Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free~     haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion~     of nitric oxide (NO) during and after the surgical procedure on CPB may protect against~     endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.~   "
95845|NCT01802606|"~     The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals~     of Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient~     collection, information registration, protocol performance.~      The investigators recruited 1200 patients with inguinal hernia undergoing inguinal~     hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly~     allocated into control group, cefazolin group and levofloxacin group, with digital meter~     method , 400 in each group. The data such as age, sex, case number, length of hospital stay,~     antibiotic usage, post-operative infection, infection site, bacterial culture were filled in~     self-designed forms on computer.~   "
95848|NCT01802567|"~     The purpose of this study is to test the feasibility (ability to be done) of experimental~     technologies to determine a tumor's molecular makeup (gene expression profile) and~     mutations. This technology called the Pediatric Gene Analysis Platform includes a genomic~     report (gene expression profile) and a DNA Mutation Panel Report that are being used to~     discover new ways to understand cancers and potentially predict the best treatments for~     patients with cancer in the future.~   "
95849|NCT01802554|"~     Cardiovascular disease and depression are some of the most costly illnesses to society, and~     caring for a loved-one with Alzheimer's disease has been associated with increased risk for~     both depression and cardiovascular disease. Indeed, depressive symptoms have been linked~     with elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are~     associated with increased risk for cardiovascular disease (CVD). The present research tests~     a brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in~     Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation~     (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers~     relative to those randomized to a time-equivalent Information and Support (IS) therapy.~   "
95850|NCT01802541|"~     Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol~     levels and reduce body fat. The investigators hypothesize that replacing dietary fat with~     diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that~     diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2~     diabetic patients.~   "
95851|NCT01802528|"~     Obturator externus (OE) muscle has the possibility as a pain generator, considering its~     anatomical and functional aspects, but this muscle as a possible target for therapeutic~     intervention is currently understudied in pain practice.~   "
95852|NCT01802515|"~     The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg~     atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above~     support the safety of atomoxetine in combination with stimulants. As the next step, the~     investigators will evaluate the safety and tolerability of atomoxetine in a small clinical~     trial with cocaine users. If atomoxetine is found to be promising in this study and~     sufficiently powered, double-blind, placebo-controlled studies will be proposed.~   "
95853|NCT01802502|"~     Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to~     50% of patients dead or neurologically disabled. Current treatment is similar to treatment~     of lung TB, although penetration of some antibiotics into the brain is poor and the~     immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II~     clinical trial from the investigators group, the first of its kind globally, intensified~     antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality~     of TB meningitis.~      The investigators aim to examine the effect of intensified antibiotic treatment on mortality~     and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative~     pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures~     similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be~     implemented much easier in low-resource settings.~   "
95854|NCT01802489|"~     Optic neuritis (ON) is a common event in Multiple Sclerosis (MS), and causes significant~     loss of nerve cells in the eye, resulting in poor vision. Optic neuritis also provides a~     sensitive way of testing the effectiveness of drugs that may help protect from loss of nerve~     cells in ON and therefore in MS.~      The investigators have identified through laboratory and early clinical research in humans~     that amiloride (a water tablet already in use) may be a drug that can be of benefit in optic~     neuritis by protecting from loss of nerves cells, ie a neuroprotective drug.~      The purpose of this study is to assess the efficacy of amiloride as a neuroprotective drug~     in optic neuritis~   "
95855|NCT01802476|"~     The purpose of this study is to determine approximately what percentage of an orally~     administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the~     systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of~     a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose~     of PD-0332991 administered as a 4-hour infusion.~   "
95856|NCT01802463|"~     Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when~     compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in~     flow velocities in the retrobulbar arteries in what appears to be related to the degree of~     the glaucomatous disease.~      The anatomic pathway of the several arteries into the eye is intricately complicate, with at~     least one of them (the central retina artery) penetrating the optic nerve before entering~     the eye and supplying the innermost structures of the globe. As the optic nerve is~     surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of~     the central nervous system, this central retinal artery has also to cross this CSF~     containing compartment. Because of the intrinsic pressure this CSF - corresponding to the~     intracranial pressure at the orbital level - the possibility exists that this pressure~     around the optic disc could affect the blood flow of the arteries that go through it.~      The investigators will try to detect if a correlation exists between the optic nerve sheath~     diameter and the blood flow in the retrobulbar vessels of glaucoma patients.~   "
95857|NCT01802450|"~     Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6~     months in patients with CP-CML who have achieved complete cytogenetic response without major~     molecular response after at least 18 months on Imatinib 400/600.~   "
95858|NCT01802437|"~     The purpose of the study is:~        1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for~          depression should get therapy before the therapist decides whether or not the teenager~          is improving enough, and~        2. to compare two ways of providing treatment to teenagers who have not improved enough.~   "
95859|NCT01802424|"~     The purpose of this pilot-study is to evaluate a cognitive behavioral program, the~     Friends-program, as indicated prevention for anxious youth. The youths are recruited by~     school nurses who will also lead the intervention groups applying the Friends-manual.~   "
95860|NCT01802411|"~     The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for~     intercostal nerve block in subjects undergoing posterolateral thoracotomy.~   "
95861|NCT01802398|"~     Syncope (temporary loss of consciousness) is a frequent reason for an emergency department~     (ED) visit among older adults. The current ED evaluation of syncope frequently leads to~     hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of~     this protocol is to improve risk prediction for syncope. Improved risk prediction will~     inform the design of interventions to safely reduce unnecessary health service use.~      This is a multi-center, prospective, observational cohort study of older (age≥60 years)~     adults who present to an emergency department with syncope (otherwise known as fainting).~     The primary outcome is a composite of 30-day cardiac death and serious cardiac events.~      Study Aims and Hypotheses are:~      Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for~     admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic~     tests.~      H1: Current patterns of care representing a diversity of practice settings and patient~     populations are costly with low clinical benefit.~      Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death~     and serious cardiac outcomes after unexplained syncope.~      H2: Explicit criteria including contemporary cardiac biomarkers will improve risk~     stratification compared to unstructured physician assessment and published risk models.~      Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to~     existing care for unexplained syncope.~      H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating~     unexplained syncope in older adults.~   "
95862|NCT01802385|"~     This is a phase III trial to determine whether adjunctive sertraline will lead to improved~     survival 18-week survival.~      There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF~     concentrations in 172 persons conducted from August 2013 to August 2014.~   "
95863|NCT01802372|"~     The goal of this study is to evaluate the comparative effectiveness of the World Health~     Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension~     control, delivered by Community Health Nurses as part of Ghana's Community based Health~     Planning and Services program, versus provision of health insurance coverage, on blood~     pressure reduction. Findings from this study will provide policy makers and other~     stakeholders needed information to recommend efficient cost-effective policy with regards to~     comprehensive CV risk reduction in patients with hypertension in low resource settings.~   "
95864|NCT01802359|"~     The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in~     participants with erectile dysfunction.~   "
95865|NCT01802346|"~     This randomized phase II trial studies how well a controlled low calorie diet works in~     reducing side effects and increasing response to chemotherapy in patients with breast or~     prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Eating a~     special diet with low calories may reduce the side effects of chemotherapy and improve the~     response to treatment~   "
95866|NCT01802333|"~     This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or~     idarubicin and cytarabine with or without vorinostat to see how well they work in treating~     younger patients with previously untreated acute myeloid leukemia. Drugs used in~     chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat,~     work in different ways to stop the growth of cancer cells, either by killing the cells,~     stopping them from dividing, or by stopping from spreading. Giving more than one drug~     (combination chemotherapy) and giving the drugs in different doses and in different~     combinations may kill more cancer cells. It is not yet known which combination chemotherapy~     is more effective in treating acute myeloid leukemia.~   "
95867|NCT01802320|"~     This phase II trial studies how well v-akt murine thymoma viral oncogene homolog 1 (Akt)~     inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer~     that has spread from the primary site to other places in the body or nearby tissue or lymph~     nodes and cannot be removed by surgery. Akt inhibitor MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
95868|NCT01802307|"~     Prostate cancer is the most common solid organ cancer among men and is the second leading~     cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and~     29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate~     cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5~     million men in the US living with prostate cancer. Standard treatment for prostate cancer~     has involved either removal of the prostate (radical prostatectomy) or application of some~     type of energy to the entire prostate gland in order to kill all of the cells--usually with~     radiation or cryotherapy (freezing).~      Over the past decade, it has become apparent that while some men will benefit from treatment~     for prostate cancer, many will not. Particularly for men with a small amount of low-grade~     (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing~     cancer is very low. However, the risk of harm from some of the treatments for prostate~     cancer is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary~     leakage, difficulty urinating and overactive bladder and bowel symptoms.~      One strategy for men with low risk prostate cancer has been to avoid immediate treatment and~     wait until the cancer starts to grow. The risk of this strategy is that some men may not be~     able to be cured once the cancer starts to grow. In addition, men who are on this active~     surveillance protocol can become very nervous, fearing that the cancer will start to spread.~      A new strategy to avoid some of the treatment harms of prostate cancer while also attempting~     to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk~     prostate cancer will have only a small piece of cancer within the prostate gland. These men~     may benefit from treating only this one area instead of the entire prostate. This will allow~     the physician to kill the cancer cells and to avoid some of the problems associated with~     treating the entire prostate.~      The purpose of this study is to investigate the use of focal, targeted treatment of prostate~     cancer, that is, to treat only the small area of cancer instead of the entire prostate. We~     hope to show that this strategy will reduce the amount of side effects without compromising~     cancer cure.~   "
95869|NCT01802294|"~     This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a~     small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The~     pilot study will use a mixed-methods approach to intervention evaluation. Self-report and~     observed quantitative data for intervention and control groups will be collected at pre-test~     and post-test evaluation. Primary outcomes will include parent-reports and observations of~     child behavior problems. In addition, as an exploratory study, this phase will examine~     initial pre-post intervention effects for potential mediating factors of parenting behavior,~     parental stress, parental depression, and perceived social support. However, this phase will~     not test mediation effects due to small sample sizes. Quantitative assessments will also~     collect data on program fidelity, exposure/adherence, participant engagement, and~     satisfaction. Furthermore, qualitative focus groups with intervention participants and group~     leaders will examine issues of program feasibility, content, deliver, and satisfaction.~     Randomization will be done on an individual level and include a wait-list control group that~     will receive the intervention 3 months after the post-test evaluation. Results from the~     feasibility pilot study will be shared with intervention partners and advisory groups. If~     necessary, final program adjustments will be made prior to further testing. Results will~     also be disseminated to community forums, local organizations, government stakeholders, and~     via academic conferences.~      Research hypotheses:~      Hypothesis 1: Children in the intervention group will demonstrate reduced observed and~     parent-reported child behavior problems in comparison to the control group.~      Hypothesis 2: Parents in the intervention group will demonstrate increased observed and~     self-reported positive parenting outcomes and decreased observed and self-reported harsh and~     inconsistent parenting outcomes in comparison to the control group.~      Hypothesis 3: Parents in the intervention group will demonstrate decreased parental~     depression and parental stress outcomes and increased perceived social support outcomes in~     comparison to the control group.~      Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable~     degree of program fidelity, exposure/adherence, and participant satisfaction.~   "
95870|NCT01802281|"~     The primary purpose of this randomized clinical trial is to compare the effectiveness and~     safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh~     augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension~     (USLS). The primary aim is to determine whether treatment success in women who undergo the~     above strategies differ at time points through 3 years.~      A supplemental study investigates anterior vaginal wall movement resulting from descent or~     rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the~     study arms of SUPeR.~   "
95871|NCT01802268|"~     Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin~     inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate~     long-term CNi associated adverse events. This study aims to evaluate the conversion from~     tacrolimus to sirolimus in de novo kidney transplant recipients.~      This multicenter, open-label study, planned to enroll 297 patients initially treated with~     tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The~     primary objective is to show superior glomerular filtration rate in the SRL group at 24~     months after transplantation.~   "
95872|NCT01802255|"~     Patients needing intensive care often require sedative drugs to reduce anxiety and agitation~     during ventilator care and invasive therapeutic and diagnostic procedures. At present there~     is no optimal sedative agent for these patients. The most commonly used sedative agents in~     intensive care units are midazolam and propofol. Both drugs have side effects of clinical~     importance.~      At present, a viable alternative to intravenous sedation is inhalatory sedation.~     Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified~     method of administration of isoflurane or sevoflurane has been developed. The Anesthetic~     Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion~     of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.~      However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than~     12 hours, since the possible renal problems posed by inorganic fluoride in prolonged~     operations remain the subject of controversy.~      The primary aim (and primary hypothesis) of the current trial is to determine whether~     sevoflurane can be administered as a sedative drug for more than 48 hours without clinically~     relevant physiopathological effects on kidney and liver function.~      Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in~     terms of sedation control, the rapidity and predictability of awakening, and the incidence~     of delirium in critical care patients.~   "
95873|NCT01802242|"~     Prostate cancer is common in males and may develop over the course of an individual's life.~     This cancer is often discovered at the time of routine physical examinations and/or blood~     work or on rectal examination. Once diagnosed, most patients do require some form of~     treatment so that the prostate cancer does not progress to cause damage and/or shortened~     lifespan. Occasionally, after patients receive treatment, the investigators have found that~     an area of cancer remains within the prostate. Those patients with a large area of cancer~     (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate~     cancer even after standard treatment. Thus, the investigators believe that the area of the~     prostate gland occupied by a dense area of cancer may need more radiation therapy than~     normal to remain cancer free.~      Standard therapy currently in place in North America: Currently patients who are diagnosed~     with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT)~     alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy~     alongside the radiation depending on their physician's preference. For those who receive~     radiation therapy, the tumor typically receives the same dose as the rest of the prostate~     gland.~      Findings to date: In the past few years the investigators have discovered that patients with~     a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of~     having cancer remain in the prostate, despite receiving treatment for their cancer 3 years~     earlier. Using new technology investigators can deliver radiation therapy after viewing the~     prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted~     to the tumor within the prostate. Based on this earlier success the investigators believe~     that they can now safely give a higher dose of radiation to specifically target the cancer~     within the prostate gland.~      Reason for the study: The investigators would like to test this technology and expertise to~     give radiation to a higher than normal dose to the tumor nodule in prostate gland.~   "
95874|NCT01802229|"~     The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes~     and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of~     umbilical port site.~   "
95875|NCT01802216|"~     The purpose of this study is (1) to determine whether a 12-month trial of patients from~     underserved communities with clinically significant gum disease and kidney disease randomly~     assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to~     determine the variability of various tests of kidney function and inflammation in response~     to intensive gum disease treatment.~   "
95876|NCT01802203|"~     To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for~     the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.~   "
95877|NCT01802190|"~     The study will allow to identify the prevalence of the SLC17A8 gene mutations in patients~     suffering from deafness. This phenotype also corresponds to DFNA15 deafness caused by POU4F3~     : mutations of this gene will be screened as well.~   "
95878|NCT01802177|"~     Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair~     loss. Many treatment modalities have been found to be helpful in AA, however, none on them~     cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in~     many dermatologic diseases. There are no prospective randomized controlled trials evaluating~     the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective~     split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB~     excimer light in the treatment of AA.~   "
95879|NCT01802164|"~     In patients undergoing laparotomy, the incidence of abdominal wall related complications~     such as incisional hernia is very high. In particular in patients with peritonitis~     undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these~     patients are at great risk for development of postoperative fascial dehiscence.~      The gold standard of abdominal wall closure is a running slowly absorbable suture~     irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh~     potentially reduces the incidence of incisional hernia.~      In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh~     prophylactically we reduced the incidence of incisional hernia down to 3.2%.~   "
95880|NCT01802151|"~     The purpose of this study is to evaluate the effect of three doses of the probiotic B.~     subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general~     wellness in healthy young adults, survival through the gastrointestinal tract and impact on~     intestinal microbes.~   "
95881|NCT01802138|"~     Activated T cell were manufactured through in vitro T cell expansion of autologous T cell.~     We designed this study to determine the feasibility and safety of Activated T-lymphocyte~     cell therapy for refractory/relapsed neuroblastoma patients.~   "
95885|NCT01802086|"~     The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief~     or no pain relief in connection to the first pneumococcal vaccination at the age of three~     months in Child health care.~      Primary objective~      1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at~     the age of three months to lower pain scores in the use of FLACC as a pain measurement~     instrument?~   "
95886|NCT01802073|"~     Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.~   "
95887|NCT01802060|"~     This study will examine the performance of the Persona assays in identifying the time when~     risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other~     indices of ovulation.~   "
95888|NCT01802047|"~     Initiating and sustaining breastfeeding are common challenges in neonatal units.~      It is known that hindmilk expressed at the end of the expression session has a higher fat~     content.~      Previous studies have shown that simultaneous pumping is more effective at producing milk~     than sequential pumping. However this approach is often felt uncomfortable by the mothers,~     and sequential pumping is preferred.~      The purpose of this study is to determine which modality of milk expression by electric pump~     is the most efficient and productive when sequential pumping is used.This is done by~     assessing the milk volume expressed per expression and its macronutrients content.~   "
95889|NCT01802034|"~     A central goal of this data repository is to collect data from a large population of~     subjects with a variety of renal disease states. Cohorts will include subjects with~     diabetes, inflammatory/autoimmune and transplant related renal conditions. Additionally, the~     repository will have the capacity to store biospecimens and electronic data in control~     subjects without established renal disease. This initiative will provide an opportunity to~     compare data from various disease states and controls with the objective of determining~     clinical and biological factors that predict disease progression, response to therapy and~     identify discriminating noninvasive clinical and biological features that predict renal~     biopsy findings.~   "
95890|NCT01802021|"~     The myeloid-derived suppressor cells (MDSCs) can further trigger cytotoxic T cell apoptosis,~     and may shift the macrophages toward M2 subtype, inhibit the Th1 cell, and initiate other~     immune suppressive mechanism. The functions of NK cells and regulatory T cells are altered,~     resulting in a disturbance of anti-tumor immune function. All these can further create an~     environment with a benefit for malignant cell growth and advancement. Astragalus-based~     formula may confer its survival advantage in cancer patients through modulating the immune~     system and reversing the immunosuppressive microenvironment.~      The investigators aim to study the role of Qingshu-Yiqi-Tang in reversing the immune~     alterations in patients with advanced stage, non-small cell lung cancer who receive 1st line~     doublet chemotherapy of cisplatin plus doxetaxel（or Pemetrexed for adenocarcinoma）and 2nd~     line target therapy of erlotinib. The investigators can explore the possible mechanism of~     the Astragalus-based formula: Qingshu-Yiqi-Tang in modulating and reversing~     immunosuppression in advanced stage, non-small cell lung cancer patients.~   "
95891|NCT01802008|"~     The objective of this study is to determine the optimal withdrawal time for colonoscopy. A~     6-minute withdrawal time is currently the standard of care but has only been evaluated in an~     observational fashion. The investigators believe that this should be validated in a~     standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie~     a low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will~     support widespread adoption of a 6 minute withdrawal as the standard of care. This in turn~     may decrease the occurence of 'interval colon cancers', which are early colon cancers~     arising in subjects despite their having undergone colonoscopy. Our hypothesis is that the~     polyp/adenoma detection rate will be unacceptably low and the polyp/adenoma miss rate will~     be unacceptably high in the 3-minute withdrawal group when compared to the 6-minute~     withdrawal group.~   "
95892|NCT01801982|"~     This single center study will monitor the developmental progress of PPHN patients who~     received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months~     following the end of study drug infusion.~   "
95893|NCT01801969|"~     The proportion of patients who return to work after surviving severe traumatic brain injury~     (TBI) has been estimated in number of studies but results do not agree.This may be due to~     complex interaction between many factors, including available rehabilitation services.~      In Denmark rehabilitation services vary been regions and municipalities. Hospital based~     rehabilitation is organized by the regions. Rehabilitation outside the hospitals is~     organized by the municipalities~      The first purpose of this study is to investigate a possible link between centralized~     hospital based rehabilitation and better return to work / quality of life.~      The second purpose is to investigate whether municipality size affects quality of life and~     return to work after severe TBI.~      Data on return to work are derived from a national register on labor market attachment. Data~     on quality of life are derived from a questionnaire.~      The study population is identified from the Danish Head Trauma Database. The completeness~     and accuracy of the database will be investigated as the first part of the project.~   "
95894|NCT01801956|"~     Background: Low levels of cardiorespiratory fitness are associated with high risk of~     non-communicable diseases and all-cause mortality. Physical activity level is the primary~     determinant of cardiorespiratory fitness in adults. However, knowledge on how to motivate~     people to engage in physical activity and maintain an active lifestyle is lacking. This~     study aims to investigate whether a motivational, individual, and locally anchored exercise~     intervention, in primary care, can improve cardiorespiratory fitness in 30 to 49 year olds~     with a low or very low cardiorespiratory fitness.~      Design: Randomised controlled trial with 6 and 12 months follow-up. The primary outcome is~     cardiorespiratory fitness. Secondary outcomes include biochemical parameters (HbA1C, HDL-~     and LDL-cholesterol, and triglyceride), physical activity level (measured by accelerometer),~     self-reported physical activity, anthropometric parameters and health-related quality of~     life.~      Methods: Cardiorespiratory fitness will be estimated via a maximal incremental exercise test~     and expressed as the index of maximum oxygen uptake per minute divided by body weight (ml~     O2/kg/min). A total of 236 participants, classified with a very low or low cardiorespiratory~     fitness at a local health check programme, (corresponding to ≤ 39 and ≤35 ml O2/kg/min. for~     30-39 and 40-49 year-old men respectively and ≤33 and ≤31 ml O2/kg/min. for 30-39 and 40-49~     year-old women respectively), will be randomised into two groups. The intervention group~     will receive 4 motivational interviews, six months membership to a sport club, and a global~     positioning watch to upload training activity to a social media. The comparison group will~     receive standard care: a one hour motivational interview. In addition to an~     Intention-to-treat analysis a per-protocol analysis will be performed. Effect of the~     intervention will be estimated by evaluating the differences in mean changes in~     cardiorespiratory fitness between the two groups.~      Discussion:In new and innovative ways the focus of this study will be to improve~     cardiorespiratory fitness among a 30-49 year-old at-risk group using social media,~     GPS-technology, on-going personal support and individually tailored physical activity.~   "
95903|NCT01801839|"~     The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And~     continuous such imbalance could lead to immunoparalysis, which is characterized by loss of~     delayed type hypersensitivity, failure of primary infections eradication, and a~     predisposition of secondary nosocomial infections development. However, in which phase of~     sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively~     understand this problem by checking monocytes/macrophages` antigen presentation and cytokine~     secretion，and by checking monocytes/macrophages` expression of Tim-3 (the T cell~     transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in~     sepsis patients` peripheral blood mononuclear cells.~   "
95904|NCT01801826|"~     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive~     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience~     Cryo-Touch IV device uses well-established principles of cryobiology to cause localized~     reduction in muscle activity resulting in a reversible reduction in facial animation and the~     appearance of facial lines. The device operates on well-established cryobiology principles;~     that localized exposure to controlled low temperature conditions can alter tissue function.~     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form~     of an assembly of small diameter needles, creating a highly localized treatment zone around~     the probe. The thermal algorithm is designed to produce a reversible loss of nerve~     conduction resulting in a temporary decrease in muscle contractility. Prior studies of~     Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness~     and safety for applications in this indication. The goal of the study described herein is to~     show the safety and effectiveness of this approach using the Cryo-Touch IV device.~   "
95905|NCT01801813|"~     Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but~     lifethreatening post-operative complications. There are currently no strong recommendations~     to help the clinician in an attempt to properly hospitalise these patients after their~     intervention (Neuro-ICU, ICU,surgical ward).~      Determining risk factors of post-operative complications could optimise resources. Therefore~     hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.~   "
95906|NCT01801800|"~     Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact~     patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World~     Neurosurgeon Federation Score ≥ III~   "
95907|NCT01801787|"~     The current study investigates the basic principles that underlie the efficacy of~     transcranial direct current stimulation for chronic auditory verbal hallucinations in~     schizophrenia in a multimodal design.~   "
95908|NCT01801774|"~     Phacoemulsification is a quick method with less complication for cataract surgery. Due to~     the use of ultrasonic energy, it produced more post-operative inflammation than other~     methods. Many routes of steroid had been used to control post-operative inflammation. The~     investigators here compare the efficacy of single depot steroid subtenon injection (20-mg~     triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling~     inflammation after uneventful phacoemulsification.~   "
95909|NCT01801761|"~     To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive~     pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a~     simplified questionnaire was developed for identifying those COPD patients with severe OSA.~   "
95910|NCT01801748|"~     Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat~     avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of~     this study were to determine the rate of oral tolerance and identify clinical and laboratory~     predictors of tolerance development in Thai children who allergic to wheat.~   "
95911|NCT01801735|"~     The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up~     to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip~   "
95912|NCT01801722|"~     The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as~     an initial step for the diagnosis of chronic heart failure in patients with COPD in primary~     health care, and to select patients for a further examination by echocardiography.~   "
95913|NCT01801709|"~     The objective of this open-label, single arm, monocentric, phase I/II clinical study is to~     assess safety and efficacy of ARSA gene transfer in the brain of children affected with~     early onset forms of Metachromatic Leukodystrophy (MLD). For this purpose, an~     adeno-associated virus serotype rh.10 (AAVrh.10) vector will be used to transfer the ARSA~     cDNA coding for Arylsulfatase A (ARSA) enzyme into the brain of children. Five patients with~     early onset form of MLD, age ranging from 6 months to 4 years, will be included in this~     protocol and will be followed during 24 months.~      Patients will be selected at presymptomatic or early stage of their disease, following~     clinical, neuropsychological and brain imaging criteria.~      Twelve simultaneous injections of the investigational medicinal product will be performed in~     the white matter of both brain hemispheres, through 6 image-guided tracks, with 2 deposits~     per track.~      A low dose (1x10EXP12 vg total) will be administered to the first 2 patients, while the last~     3 will receive a higher dose (4x10EXP12 vg total).~      Safety and efficiency will be evaluated based on clinical, neuropsychological, radiological,~     electrophysiological and biological parameters.~   "
95914|NCT01801696|"~     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute~     at Western Oregon University (WOU) will be conducting research on the effect of a~     parent-delivered massage program on measures of autism and general development in young~     children with autism. Families will participate in an initial training, and receive 24~     sessions of ongoing support and training from a trained therapist over the first nine~     months.~   "
95915|NCT01801683|"~     Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all~     specialties, including family medicine. Various issues in diagnosis, treatment and prognosis~     appear in daily work with patients and a physician should provide answers based on the best~     evidence stemming from research. In spite of having access to EBM databases in every GP's~     office in Croatia, searching and finding answers in consultation with a patienton the spot~     in real time is missing from practice.~      OBJECTIVES: To determine GP's knowledge and attitudes about EBM before and after applying~     modified academic detailing EBM intervention. provided by sixth- year medical students We~     assume that GP's knowledge and attitudes about EBM will change as a result of EBM~     intervention applied by students.~   "
95916|NCT01801670|"~     Mycosis Fungoides (MF) is a rare malignancy in the United States. It is the most common form~     of cutaneous T-cell lymphoma (CTCL). Sézary syndrome (SS) is the most severe and leukemic~     form of CTCL. Pruritus, or itch, is defined as an unpleasant sensation that elicits the~     desire to scratch. Severe itch is a manifestation of all forms of MF, especially those with~     patch/plaque and folliculotropic variants, as well as in Sezary patients. While severe itch~     causes great suffering for patients, the pathogenesis of itch in MF and Sezary syndrome is~     complex and not well understood. It is thought that various chemical mediators are produced~     by the malignant cells to cause itch. Vorinostat, an FDA approved therapy for the treatment~     of MF, has also been reported to relieve pruritis. The goal of the study is to evaluate how~     vorinostat affects different chemicals in the skin that have been known to cause itch. This~     is a single center, non-randomized study designed to obtain and test blood and skin tissue~     samples take at various time-points over 6 months in patients who are prescribed vorinostat~     per standard of care treatment. Samples from pruritic and non-pruritic skin and blood of MF~     and Sezary patients will be evaluated for the presence of chemicals thought to be important~     in the cause of itch in these diseases. This evaluation will include immunohistochemistry,~     RT-PCR, and ELISA assays. The results from this study may help define how vorinostat~     decreases itch in patients with MF and Sezary Syndrome.~   "
95917|NCT01801657|"~     Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and~     bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which~     may be accompanied by recurrent exacerbations.It has been increasingly recognized that~     respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary~     diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis.~     However,little is known about the roles of viral infection in driving exacerbations of~     bronchiectasis.This study aims to identify the frequency of common viral infections and~     determine the roles that viruses play in acute exacerbations of bronchiectasis.~   "
95918|NCT01801644|"~     To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in~     locally advanced bladder cancer.~   "
95919|NCT01801631|"~     Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result~     in a decreased quality of life and increased distress. According to the American Diabetes~     Association, transition from the acute care setting is a high-risk time for all patients,~     but tailored support specific to diabetes is scarce in that period. The investigators~     developed an intervention by a diabetes nurse to help diabetic patients reduce distress~     after their first ACE. The intervention is based on Bandura's Social Cognitive Theory,~     Leventhal's Common Sense Model, and on results of focus groups which were conducted to~     define the needs and wishes of type 2 diabetes patients and their partners regarding~     professional support after an ACE. The aim of this study is to evaluate the effectiveness of~     the intervention to reduce distress. The hypothesis is that patients who receive the~     intervention will have less diabetes related distress compared to the control group.~      Methods/Design: Randomized controlled trial. Patients will be recruited directly after~     discharge from hospital. A diabetes nurse will visit the patients in the intervention group~     (n = 100) within three weeks after discharge from hospital, two weeks later and two months~     later. The control group (n = 100) will receive a telephone consultation. The primary~     outcome is diabetes related distress, measured with the Problem Areas in Diabetes~     questionnaire (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c,~     blood pressure and lipids. Mediating variables are self-management, self-efficacy and~     illness representations. Variables will be measured with questionnaires directly after~     discharge from hospital and five months later. Biomedical variables will be obtained from~     the records from the primary care physician and the hospital. Differences between groups in~     change over time will be analyzed according to the intention-to-treat principle.~      Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after~     discharge from the hospital. This trial will provide evidence of the effectiveness of a~     supportive intervention to reduce distress in these patients.~   "
95920|NCT01801618|"~     Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia~     is poorly documented when the numbers of patients on treatment and their duration are~     increasing. For patients in treatment failure , there is no alternative ARV regimen~     available to date.~      This operational research aims to evaluate the Cambodian National Program PI-based 2nd line~     antiretroviral regimen to assess the proportion of treatment failure and drug resistance~     ;identify the structural and individual factors associated with treatment failure ; design~     alternative salvage ARV regimens.~   "
95921|NCT01801605|"~     The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic~     Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome~     (IBS) in a prospective, randomized, double-blind study.~   "
95922|NCT01801592|"~     The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea~     is in individuals with intermittent claudication.~   "
95923|NCT01801579|"~     Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise.~     The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus,~     it appears important to know whether automatic assessment of ABI is as reliable and~     reproducible as the manual method.~   "
95924|NCT01801566|"~     This study aims to evaluate the treatment with single implant overdenture for the edentulous~     mandible. The investigators hypothesize that treatment with lower overdenture retained by a~     single implant appears to have satisfactory effectiveness as a treatment for patients with~     specific conditions (such as maladaptive patients), with the advantages of simplicity and~     greater immediate benefits when compared to the conventional full denture, improving the~     retention and stability of the denture and better oral-related quality of life.~   "
95925|NCT01801553|"~     The purpose of this study is:~      - To validate or not the interest of the classification using the pragmatic application of~     clinical predictive rule for low back pain to identify patients with good prognosis~     following a brief spinal manipulation intervention.~      Patients (n = 100 to 150) :~      Recruited from emergency department of Saint-Luc hospital by medical doctors~      Inclusion criteria:~      A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending)~     and a pain duration < 16 days and no symptoms distal to the knees, male and female patients~     aged 19-55 years.~      Exclusion criteria:~        -  Specific LBP (red flags) and radiating beyond the knee~        -  Low Back Pain Non-specific subacute and chronic~        -  Recurrent low back pain (more than 3 painful episodes)~        -  Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR)~          > 90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during~          standing flexion), pregnancy and post-partum status~        -  High irritability = necessity of opioid medication or intravenous injection of~          medication in the emergency department~        -  previous history of surgical intervention in the low back area~      Intervention:~      - 3 sessions within one week of spinal manipulation (thrusts, grade V)~      comparison:~      - 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a~     grade II~      Co-intervention similar in both group:~      = traditional medical care (TMC)~      - Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if~     needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van~     Tulder et al. 2006 ; Koes et al. 2010).~      Outcomes:~      Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed~     to treat (NNT) analysis and intention to treat analysis on all outcome variables:~        -  Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity~          (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to~          improve his LBP~        -  Secondary: Pain in the presentation with visual analogical scale (VAS) and the~          repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and~          function), patient specific function (PSF), fear avoidance beliefs questionnaire~          (FABQ), Start back tool, physical examination, medication use, return to work and~          treatment side effects, patient's belief in a real MT intervention or not (at the end~          of the follow-up)~      Study design:~        -  Double blind ie: patients and assessors blind.~        -  The methodological quality of the study is the 8-9/10 on the PEDro scale, we will~          strictly follow the CONSORT statement and will be register in clinical.trials gov~      Evaluators:~      Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL)~      Responsible for the study: Henri Nielens (MD-PhD-UCL)~      Practitioner and investigator:~      Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual~     Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL)~     Belgium~      International collaborator:~      Timothy Flynn (PT-PhD), Regis University, Denver, USA~   "
95926|NCT01801540|"~     The purpose of this study is to investigate the effect of a meal containing different doses~     of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring~     the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and~     GLP-1) to explain the correlations.~   "
95927|NCT01801527|"~     Background: Cancer is increasingly viewed as a chronic disease and therefore there is a~     growing need for long-term treatments. Breast cancer survivors suffer physical impairment~     after oncology treatment. This impairment reduces quality of life (QoL) and increases the~     prevalence of conditions associated to unhealthy life-style.~      Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short~     and long-term effects telehealth program.~      Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited~     through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio~     Hospital and associations of breast cancer patients in Granada. Patients will be randomized~     to receive the online rehabilitation group (n=36) or usual care (control) group (n=36).~     Telerehabilitation group will receive an eight-week online intervention and control group~     receive recommendations about usual care.~      Discussion: The investigators study attempts to increase the level of fitness and reduce~     musculoskeletal disorders in breast cancer patients through a strategy for care based on~     telerehabilitation to promote therapeutic exercise.~   "
95931|NCT01801475|"~     This is called Aim 1 of the investigators' NIH grant. Ondansetron (Zofran) is a safe and~     effective drug used in pregnant women to prevent nausea but the investigators do not know~     what effect pregnancy may have on the metabolism of Zofran in pregnant women or their~     babies. Therefore the investigators will enroll approximately 40 pregnant women and their~     babies and draw blood samples from the mother, the baby and the cord, to determine how much~     Zofran is in each sample of blood (called the pharmacokinetics or PK of Zofran). The~     pregnant women will receive Zofran, as a standard-of-care drug, for their scheduled Cesarean~     Section.~      The investigators will also enroll about 20 non-pregnant women undergoing surgery who will~     receive Zofran as standard-of-care during surgery. In both the pregnant & the non-pregnant~     women, the investigators will draw blood samples at the same time points based on number of~     minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the~     investigators move into Aim 2 of the study, which will be done in pregnant,~     narcotic-addicted mothers and their babies who are born addicted to narcotics. Aim 2 will be~     listed separately as it will be an interventional study.~   "
95932|NCT01801462|"~     Ultrasonography has become increasingly used in many medical specialties over the last~     decades as smaller and less expensive ultrasound equipment has become available. Although~     ultrasound imaging traditionally is considered safe, its use is highly operator dependent~     (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that~     eventually compromise patient safety due to unnecessary tests or interventions (Moore &~     Copel 2011). A recent report from the British National Health Service (NHS) analyzed~     maternity claims reported to the NHS over the past decade and identified antenatal fetal~     ultrasound investigations as one of the four major risk areas in obstetric care (NHS 2012).~     This study therefore aims to explore the effects of simulation-based ultrasound training on~     patient comfort levels and the need for re-examination by a second physician due to~     diagnostic uncertainty.~   "
95933|NCT01801449|"~     Background:~      - Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated~     episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most~     treatments for DIRA are intended to control the immune system to stop these inflammations.~     There are drugs that can treat DIRA, but they have to be given daily as injections.~     Researchers want to try another drug, rilonacept, as a treatment for DIRA. It needs to be~     given only once a week. Rilonacept will be given to individuals who are at least 3 months~     old and who have DIRA.~      Objectives:~      - To test the safety and effectiveness of rilonacept for children and adults with DIRA.~      Eligibility:~      - Individuals at least 3 months old who have DIRA.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Other tests to study pain and movement will be given.~          Imaging studies such as bone density scans and x-rays may also be taken.~        -  Participants will have a minimum of four to five study visits over 12 months. Those who~          are on different anti-inflammatory drugs (such as anakinra) will stop taking them~          before beginning the study visits.~        -  Participants will have rilonacept injections weekly while on this study. The dose will~          be adjusted as needed to help treat the DIRA symptoms. Participants will keep a diary~          to monitor their symptoms and any side effects.~        -  Treatment with rilonacept will be given for 1 year. Participants will have study visits~          to monitor the treatment. They will provide blood samples and have other tests at these~          study visits.~   "
95934|NCT01801436|"~     The purpose of this post marketing study is to determine the plasma concentration of~     bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug~     enters and leaves the blood and tissues over time) properties in the Taiwanese population.~     It will also provide expanded access (expanded access, sometimes called compassionate use,~     is the use of an investigational drug outside of a clinical trial to treat a participant~     with a serious or immediately life-threatening disease or condition who has no comparable or~     satisfactory alternative treatment options) to bortezomib for the same group of participants~     with multiple myeloma (cancer of the types of cells normally found in bone marrow).~   "
95935|NCT01801423|"~     Given large absolute numbers of individuals with sickle cell disease in Nigeria, hydroxyurea~     therapy for all individuals with sickle cell disease may not be initially feasible; however,~     a targeted strategy of hydroxyurea use for primary prevention of strokes is an alternative~     to the standard therapy (observation) for high-risk individuals. The investigators propose a~     feasibility study, Sickle Cell Disease - Stroke Prevention in Nigeria (SPIN) Trial, to~     determine whether hydroxyurea can be used for primary prevention of strokes in Nigerian~     children with sickle cell anemia.~   "
95936|NCT01801410|"~     Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia.~     Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with~     pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby,~     preferably by vaginal route, is vital in order to achieve good maternal and neonatal~     outcomes. Induction of labour is therefore a critical intervention in order to prevent~     morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and~     transcervical Foley catheterization - are already used by some in low resource settings, but~     their relative risks and benefits are not known. These interventions could optimize the care~     pathway for women needing induction of labour. This is especially important in low resource~     settings where improvement is most needed and the potential to reduce the maternal and~     neonatal mortality and morbidity is the greatest. The ideal induction agent would result in~     a relatively short induction to delivery interval without risk to fetus and with low rates~     of emergency caesarean section. The induction to delivery interval is especially important~     in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery.~     Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine~     hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley~     catheter as an induction agent has been persistently questioned. This study will identify~     the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two~     low cost induction methods.~   "
95937|NCT01801397|"~     Study Title:~      A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia~     Nervosa patients with low mineral density and increased bone fragility (FAN-Trial)~      Short Title/Study ID:~      FAN-Trial / Psy-Rheu_2011/1~      Indication:~      Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility~     fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available)~     without fragility fractures in Anorexia Nervosa patients~      Trial Design:~      Open-label, single-centre pilot study with study drug treatment duration of 24 months.~      Study Center:~      Single-centre (University Hospital of Zürich)~      Investigator(s)/Authors:~      PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry,~     Centre for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P.~     Frey (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich,~     CH-8091 Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg~      Objective(s)/Outcome(s):~      Primary endpoint:~      •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in~     the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone~     density at months 12 and 24.~      Secondary endpoints:~        -  To assess the changes in blood biomarkers~        -  To assess changes in whole body composition~        -  To assess the incidence of new fragility fractures~        -  To assess changes in bone structure~        -  To assess the changes in EDE-Q~        -  Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN~      Assessments for primary endpoint:~      •BMD at lumbar spine, total hip and femoral neck, measured by DXA~      Assessments for secondary endpoints:~        -  bone resorption and bone formation markers measured in urine and serum~        -  whole body composition measured by DXA~        -  New clinical peripheral and vertebral fractures~        -  HRqCT of tibia and forearm~        -  EDE-Q Score at months 12 and 24~      Safety measurements:~        -  Safety lab (blood and urine)~        -  Clinical adverse event monitoring at all visits Number of Subjects: 10~      Diagnosis and Main Inclusion Criteria:~        -  Women, aged > 18 to < 35 years~        -  Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening~        -  Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score <~          -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4,~          total hip, femoral neck) without any previous fragility fracture~        -  or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available)~          of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral~          neck) and at least one previous fragility fracture~        -  In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry~          and Psychotherapy of the University Hospital of Zurich.~      Main Exclusion Criteria:~        -  Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism,~          osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal~          impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the~          skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum~          alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV~          positive patients, pregnancy, open epiphyses~        -  Incapacity to understand the aims of the study or patients not willing to collaborate.~      Study Product, Dose, Route, Regimen:~      Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.~      Duration of study:~      24 months.~      Reference therapy, Dose, Route, Regimen:~        -  Trial with medicinal product~   "
95938|NCT01801384|"~     The major goal of this project is to examine the efficacy of a voucher-based incentive~     program for promoting smoking cessation (Study 1) and preventing relapse (Study 2) during~     pregnancy and postpartum. Identifying efficacious interventions to increase cessation rates~     and decrease relapse among those who are able to quit is important to improving U.S. public~     health.~   "
95939|NCT01801371|"~     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study~     to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in~     glioma patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤40 µg BNOTA-PRGD2) will~     be intravenously injected into patients in suspicion of glioma. Visual and semiquantitative~     method will be used to assess the PET/CT images. Brain MRI with/without enhancement and~     18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin~     αvβ3 and CD34 immunohistochemical stains will also be used for correlation.~   "
95940|NCT01801358|"~     A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with~     confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose~     limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the~     combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used~     in a Phase II part of the study, which will enrol 55 patients each into two randomized~     groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof~     of concept is established. Patients will continue treatment as long as clinical benefit is~     seen and no limiting adverse toxicity is observed~   "
95941|NCT01801345|"~     The primary aim of this randomized controlled trial is to examine the effect of fatigue on~     clinical performance in a simulated obstetric emergency. This scenario was chosen because it~     is a common clinical situation faced by anesthesia providers on call and therefore likely to~     occur when a provider is fatigued. Secondary outcomes will include the evaluation of other~     factors that worsen fatigue related decrement in performance including age, years of~     training/practice and clinical load prior to study participation.~   "
95942|NCT01801332|"~     To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in~     association with corticosteroïds in patients with severe acute alcoholic hepatitis.~   "
95943|NCT01801319|"~     This is a randomized, placebo-controlled double-blind cross-over trial evaluating the~     safety, efficacy, daily functioning, and health-related quality of life of Subcallosal~     Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant~     Depression (TRD). A total of 40 eligible participants will be randomized to four treatment~     sequences (10 participants per sequence). Each participant will be treated over a 6-month~     period with active or sham stimulation in which both the participants and the attending~     psychiatrists will be blinded to treatment allocation.~   "
95944|NCT01801306|"~     To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring~     (NeMo Probe) and the accuracy of measurement values.~      To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and~     oxygenation during cerebrovascular events monitored with established methods including brain~     tissue oxygenation tension and microdialysis~   "
95945|NCT01801293|"~     This is a single center, open-label, Phase 1 study to determine the mass balance of of~     GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in~     healthy subjects.~   "
95946|NCT01801280|"~     The objective of this pharmacokinetic study is to examine a possible drug-drug interaction~     of Pantoprazole on the bioavailability mycophenolic acid administered as either~     Mycophenolate mofetil (Cellcept(R) or Mycophenolate Sodium; EC-MPS (Myfortic (R) in stable~     renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low~     dose glucocorticoids).~   "
95947|NCT01801267|"~     Ventriculoperitoneal shunts are the standard of care for patients with communicating~     hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail~     within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would~     not work in this population and is better suited to patients with obstructive hydrocephalus~     (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists~     learn more about CSF and the way our brains absorb this fluid, they have learned that this~     may not be so straight-forward. Recent small studies have shown that ETVs can work in a good~     percentage of children with communicating hydrocephalus, too. But no randomized controlled~     trials have been done to compare these two treatments directly to determine which will~     provide children with a better prognosis, fewer surgeries over their lifetime, less time in~     the hospital and the greatest chance at as normal a life as possible.~      The investigators will conduct a trial to compare these two surgical treatments where~     patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown~     to have a high failure rate in newborns, the investigators will not include these patients~     and instead will study patients who come to Duke University with communicating hydrocephalus~     between the ages of 1 year and 18 years. The study will include patients with ventricular~     shunts who are in need of revision and patients who were just diagnosed and need their first~     shunt.~      All patients who agree to participate will be randomized to receive either an ETV or a~     shunt. The study team will follow them for one year from the time of the surgery and will~     determine what percentage of patients require further CSF-related surgeries, how long they~     go after their surgery before they need another surgery, how much time they spend in the~     hospital and what percentage of patients suffer CSF-infections or other problems related to~     the surgery or their hydrocephalus. The study team will examine these results and determine~     if ETV is a safer or more effective treatment for children with communicating hydrocephalus~     than is a ventricular shunt.~   "
95948|NCT01801254|"~     The field of neuroeconomics has begun to elucidate neural mechanisms underlying~     self-control; however, researchers have not yet harnessed neuroeconomics findings to develop~     interventions for improving self-control ability. The investigators are currently developing~     such an intervention. The investigators' approach involves using a brain-computer interface~     with audiovisual feedback to show people what is happening in their own brains, in real~     time. Through this interface, individuals are trained to increase levels of neural activity~     that may facilitate self-control, which, in turn, may improve the ability to exhibit~     self-controlled behaviors. This may increase the ability to engage in heath behaviors for~     which self-control is required (eg, dieting and exercising). The investigators' long-term~     goal is to create a tool that will help people develop the self-control needed to achieve~     lasting improvements in health behaviors.~   "
95949|NCT01801228|"~     This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone,~     a selective aldosterone antagonist, regarding efficacy and hormonal side effects when~     treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The~     investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment~     of ascites with less side effects such as painful gynecomastia.~   "
95950|NCT01801202|"~     -  The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for~          removal of unwanted hair, and will result in hair removal and permanent hair count~          reduction.~        -  Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.~        -  Each subject will receive five treatments at four to six week intervals and return for~          follow-up visits at three and six months after the last treatment for evaluation of the~          treated areas.~   "
95957|NCT01801111|"~     This open-label, non-randomized, multicenter phase I/II study will evaluate the safety and~     efficacy of RO5424802 in patients with non-small cell lung cancer who have ALK mutation and~     failed crizotinib treatment. In Part 1, cohorts of patients will receive escalating doses of~     RO5424802 orally twice daily. In Part 2, patients will receive the recommended phase II dose~     of RO5424802 as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the~     same dose until disease progression. In Part 3, following disease progression, patients~     without EGFR mutation will be offered continued treatment with RO5424802, patients with EGFR~     mutations will be offered a combination of RO5424802 and Tarceva (erlotinib).~   "
95958|NCT01801098|"~     The development of a high grade AV-block is a frequent complication associated with~     transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be~     enrolled in this study. The HV-interval will be determined before and immediately after~     implantation.~      The hypothesis is that a prolonged HV-interval is associated with a high rate of complete~     AV-block following TAVI.~   "
95959|NCT01801085|"~     This is a prospective time-and-motion study to document and compare the time used in~     preparation, dispensing and administration for capecitabine/oxaliplatin (XELOX) versus IV~     5-FU/leucovorin/oxaliplatin (FOLFOX4) regimens in colorectal cancer (CRC) patients.~   "
95960|NCT01801072|"~     After a thorough review of the existing literature as well as a review of our own practice,~     the investigators have concluded that the decision to treat patients undergoing aneurysm~     repair with levetiracetam has reached true clinical equipoise. In other words, the~     investigators cannot favor a decision to either administer or not administer this drug in~     these patients based on the existing information. The utility of anti-epileptic prophlaxis~     in the perioperative period for patients undergoing intracranial aneurysm repair remains a~     common practice that is not supported by the current literature that includes retrospective~     analyses as well as prospective trials for similar but not identical types of patients. The~     investigators propose to settle this dilemma by performing a prospective randomized trial in~     patients undergoing aneurysm repair in order to definitively determine if the common~     practice of perioperative antiepileptic drug administration has any utility.~   "
95961|NCT01801059|"~     This randomized clinical trial focused on activating the patient to ask their health care~     provider for a colorectal cancer screening test to improve screening rates for colorectal~     cancer. The patient activation intervention may increase information seeking, number of~     screening tests ordered and number of completed screening tests for colorectal cancer.~   "
95962|NCT01801046|"~     This phase I trial studies the side effects of donor stem cell transplant in treating~     patients with high risk acute myeloid leukemia. Giving low doses of chemotherapy before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells when they do not~     exactly match the patient's blood. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect)~   "
95963|NCT01801033|"~     Background:~      - Hypothyroidism is a condition caused by the loss of function of the thyroid gland. The~     thyroid gland produces two hormones, T4 and T3. These hormones control the metabolism and~     function of many organs. Lack of energy, depression, and constipation are common symptoms of~     hypothyroidism. T4 is converted into T3, the active form of thyroid hormone, by two enzymes~     called deiodinases. People with hypothyroidism are treated with a synthetic T4 hormone,~     which the enzymes convert to T3. This treatment is usually effective, but some people~     continue to have symptoms even after treatment. Some researchers think that this may be~     caused by a problem with the enzymes that convert T4 into T3. They want to look at how the~     enzymes regulate the levels of T4 and T3 in the blood. They will do so by using a drug that~     blocks the action of one of the two enzymes.~      Objectives:~      - To look at how thyroid hormone enzyme blocking affects hypothyroidism treatment~     medication.~      Eligibility:~      - Individuals at least 18 years of age who have hypothyroidism and are on thyroid hormone~     replacement therapy.~      Design:~        -  The study consists of one screening visit, 9 days of inpatient hospital admission, and~          a follow-up visit 2 weeks after discharge.~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples.~        -  Participants will receive balanced-diet meals to take home for the 2 days before they~          enter the hospital. They will continue this diet while in the hospital.~        -  During the inpatient stay, participants will be monitored with regular blood tests.~          They will have the following procedures:~        -  Continued thyroid hormone replacement for all 9 days.~        -  Drug to block thyroid enzyme for 7 days.~        -  Metabolism test, with room temperature changes, on days 1, 2, 5, 8, and 9.~        -  Measurements of body fat on days 2, 5, and 8.~        -  Blood glucose tests on days 1 and 9.~        -  Muscle contraction tests on days 1, 2, 4, 5, 8, and 9.~        -  Heart imaging studies on days 2, 5, and 8.~        -  Optional skeletal muscle and fat tissue biopsies on days 1 and 9.~        -  There will be a follow-up visit 2 weeks after leaving the hospital. Participants will~          have a final physical exam and provide blood samples.~   "
95964|NCT01801020|"~     Introduction: Temperature measurement is a crucial and integral element in the assessment of~     the emergency department patients. The basis of triage and treatment is often directly~     influenced by temperature measurement. The finding of hyper/hypothermia may differentiate~     between a simple urinary tract infection and pyelonephritis, or in more extreme cases may~     discern weakness in the elderly from sepsis. This brief encounter of temperature~     measurement may be paramount to the medical treatment of the emergency department patient.~     The investigators will explore the different modes of temperature measurements in emergency~     department patients.~   "
95965|NCT01801007|"~     The purpose of this study is to evaluate the safety and effectiveness of the MicroVention~     Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked~     intracranial aneurysms.~   "
95966|NCT01800994|"~     ASTHMA:~      Asthma is a chronic inflammatory disorder of the airways in which many different types of~     cells, and various cellular components. The chronic inflammation causes an increase of the~     over-responsiveness of the airways, which leads to recurrent episodes of wheezing,~     breathlessness, chest tightness, and coughing, particularly at night or in the early morning~     hours. These episodes, usually associated with widespread but variable block the airway,~     which is usually reversible either spontaneously or by treatment.~      Asthma is one of the most common chronic diseases worldwide, posing significant social~     burden in both children and adults. It is estimated that about 300 million people currently~     suffer from asthma. The incidence of asthma is universal regardless of the level of~     development of the country. There is evidence that over the last 20 years the prevalence has~     increased significantly, specially in pediatric populations.~      COPD:~      Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem. It is the~     fourth leading cause of chronic morbidity and mortality in the United States after heart~     disease, strokes and acute respiratory infections, while on an annual basis, the disease~     robs the lives of more than 3,000,000 people around us worldwide. The most worrying is that~     the impact has been steadily rising, and this dramatic increase in the frequency shows that~     by 2020 the disease will be the third leading cause of death. In Greece, 8.4% of the~     population suffers from COPD.~      Smoking is the leading cause of COPD. However, not all smokers develop the clinical picture~     of COPD, suggesting that additional factors are involved in manifestation. Further~     investigation of risk factors for COPD, methods of reducing exposure to these agents and the~     molecular and cellular mechanisms involved in the pathogenesis remain a major area of~     research to develop effective treatments that will reduce or prevent the development the~     disease.~   "
96039|NCT01800045|"~     Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic~     patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks~     per week).~      The patients will be treated during 7 weeks with Pitolisant or placebo.~   "
95967|NCT01800981|"~     Once the victim survived the acute phase, the outcome of wound healing, the scarring, became~     a major medical issue with complications that may lead to cosmetic and functional sequelae.~     Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface~     texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease~     function.~      Thus, functional and cosmetic outcomes became at least important as wound closure in~     assessing wound healing products~   "
95968|NCT01800968|"~     The primary objective is to test the hypothesis that, compared with placebo, therapy with~     Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge~     period will be associated with greater clinical stability at six months as assessed by a~     composite clinical endpoint.~   "
95969|NCT01800955|"~     It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness~     of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison~     with a sham diathermy treatment. The resistive capacitive diathermy is a medical device~     supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce~     pain and inflammation and allowing healing processes. The sham diathermy treatment is~     administered with the device set on on but not active (not supplying energy). Each~     subject, randomly assigned to either resistive capacitive diathermy treatment (group 1) or~     sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for~     a total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and~     McMaster Universities Arthritis Index) to assess pain and physical functioning, a visual~     analogic scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research~     Council Scale). Outcome measures are administered at baseline (T0), at the end of the~     treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.~   "
95970|NCT01800942|"~     The last decade has witnessed an important reduction of the mortality in children under 5~     years but such reduction has not impacted in neonates. Mortality in neonates contributes 40%~     of all deaths occurring in children below 5 years of age.~      Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease~     follows bacterial infection. Individuals can be infected without developing disease~     (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan~     Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very~     common in all age groups, with the consequence that occurrence of bacterial disease is one~     of the highest in the world.~      Newborns can be infected during labour - when passing through the birth canal - and during~     the first days/weeks of life, as a consequence of the close physical contact with the~     mother, if the latter carries bacteria in the nasopharyngeal tract.~      If the mother is an important source of bacterial infection to the newborn, treating mothers~     with a powerful antibiotic during labour should decrease bacterial carriage and therefore~     diminish the risk of bacterial transmission to the newborn during the first days/weeks of~     life, which should in turn result in the lower occurrence of severe bacterial disease and~     hence lower mortality.~      The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin~     given to women in labour on bacterial carriage of the newborn as well as the women during~     the first month after delivery.~      The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has~     already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause~     mortality when administered to everybody in a community (mass drug administration). This~     specific antibiotic has several advantages for being deployable as a simple intervention in~     rural Africa, i.e. it requires a single oral administration, it has no special storage~     requirements and it has the potential to eliminate many of the bacteria commonly causing~     severe disease in newborn.~      This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If~     an impact is shown, the next step would be to conduct a larger study aiming at establishing~     if the intervention, implemented at a lower level of care (most African women deliver at~     home assisted by traditional birth assistants), decreases the occurrence of neonatal~     bacterial disease~   "
95971|NCT01800929|"~     The purpose of this study is to evaluate the performance and usability of the N6 system in~     children with the N5 system.~   "
95972|NCT01800916|"~     The aim of the the current investigation is to develop new soft and more flexible 1-piece~     ostomy products.~   "
95973|NCT01800903|"~     The aim of the study is to evaluate safety and performance of a new catheter~     coating,compared to the current SpeediCath coating.~   "
95974|NCT01800890|"~     The aim of the current clinical investigation is to evaluate the performance and safety of~     new 2-piece ostomy product concepts.~   "
95975|NCT01800877|"~     The purpose of this research study is to determine if it is better to give vasopressors to~     patients to maintain a higher blood pressure target versus a lower blood pressure target.~     This study is important because the information we find out will help us know how best to~     administer vasopressors in patients with shock in the ICU.~   "
95976|NCT01800864|"~     Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are~     high in obese subjects indicating resistance to the actions of leptin. High leptin levels~     have been associated with increased cardiovascular and metabolic risks, but it is not clear~     if increased leptin or leptin resistance contributes to the increased cardiovascular risk.~     Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue~     functions are not completely investigated in humans. Based on preliminary data the~     investigators hypothesize that resistance to leptin action in obese adipose tissue is~     responsible for altering the expression of adipose tissue proteins which contribute to the~     development of cardiovascular and metabolic dysfunction. To test this hypothesis the~     investigators propose a novel study directed at investigating the leptin dependent changes~     in adipose tissue protein expression using adipose tissue obtained from lean and obese human~     subjects~   "
95977|NCT01800851|"~     Weight gain is a common complication after transplantation. It has adverse effects such as~     hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the~     increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved~     by a suitable dietary intervention in these patients transplanted kidney can correct lipid~     disorders and facilitate balance blood pressure. The identification of mechanisms~     responsible for weight gain would suggest prevention strategies and allow to align the~     caloric energy needs of renal transplant patients.~   "
95978|NCT01800838|"~     This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and~     photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin~     lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes~     active when it is exposed to a certain kind of light. When the drug is active, cancer cells~     are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.~      Funding Source - FDA OOPD~   "
95979|NCT01800825|"~     Preterm birth has been linked to certain types of vaginal infections. The goal of this study~     is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal~     pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate~     of preterm birth compared to women given a placebo(starch)~   "
96070|NCT01799629|"~     To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the~     elimination of meconium from the large intestine and thus reduce the incidence of feeding~     intolerance in very low birth weight (VLBW) infants~   "
95980|NCT01800812|"~     Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of~     either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed.~     Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also~     performed.~   "
95981|NCT01800799|"~     This study will enroll 30 female patients with the first time urinary tract infection (UTI),~     30 female patients with recurrent UTI and 10 female without any prior history of UTI or~     urinary tract pathology will be invited to serve as the controls. Urine samples will be~     collected in the patients at baseline, 7 days after antibiotics treatment, and 2 weeks, 4~     weeks, 8 weeks, and 12 weeks. Urinalysis will be performed at each visit and urine culture~     will be performed at baseline and at the 2 weeks and 3 months visits. Urine samples at~     baseline and 3 months will be collected from the controls for comparison.~   "
95982|NCT01800786|"~     The overarching goal of the research proposed here is to test the hypothesis (i) that the~     pathophysiological mechanisms of OSA lead to deterioration in sleep-dependent memory~     consolidation across memory systems, with the genetic marker APOε4 as a modulator, and (ii)~     that CPAP can reverse some or all of these measured memory deficits.~      In addition, we are exploring which aspects of OSA (e.g., changes in sleep architecture,~     measures of hypoxemia, or the EEG power spectrum) most likely impact sleep-dependent memory~     processing.To this end, we are using specific cognitive tasks for which sleep-dependent~     memory consolidation processes have previously been demonstrated by our group and others. In~     addition, we are carrying out quantitative EEG power spectral analyses, to delineate~     abnormal functioning of brain regions with more precision.~   "
95983|NCT01800773|"~     Although evidence-based treatments for PTSD exist, a significant minority of individuals do~     not benefit from these treatments and many individuals to not seek treatment, citing~     barriers such as time commitment and expense of treatment. The goal of the proposed study is~     to establish an alternative PTSD treatment that is effective and efficient.~   "
95984|NCT01800760|"~     The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides~     (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and~     after dietary challenges (high carbohydrate meal, high fat meal).~   "
95985|NCT01800747|"~     The general hypothesis is that delayed antibiotic treatment strategy present similar~     effectiveness, when compared with non-prescription of antibiotics or the prescription of~     antibiotics, in the non-complicated acute respiratory tract infections in pediatric~     patients.~   "
95986|NCT01800734|"~     Physiology studies will be performed in patients with type 1 diabetes to define during a~     standardized mixed meal test: 1. The relationship between fast insulin analogue~     administration by i.v. infusion or by subcutaneous pumps and plasma insulin concentration~     and tissue insulin action; 2. The relationship between insulin action, glucose fluxes and~     glucose concentration, the latter one as measured in plasma or estimated by a s.c.~     glucose-sensor; 3. The concentration curves of some potential modifiers of the~     glucose-insulin system (i.e.: glucagon, incretin hormones, free fatty and amino acids).~      On the basis of these data, in silico phenocopies of the patients (virtual patients) will be~     created to measure the glucose control coefficients, which quantify the role played by each~     component of the glucose-insulin system on glucose concentration.~      One final purpose of this research is to develop and to optimize an algorithm able to~     integrate continuous glucose monitoring with continuous subcutaneous fast insulin analogue~     infusion, known as closed-loop control (CLC) or artificial pancreas.~   "
95987|NCT01800721|"~     The present study includes a randomized clinical trial of a peer health education~     intervention and a 12-month longitudinal study. The sample will include Black Men who have~     Sex with Men (MSM) who will be randomized into an experimental or control condition and then~     asked to recruit peer and risk network members for HIV testing over a 3 month period. Some~     of the network members who are recruited for voluntary counseling and testing (VCT) will~     enroll into the longitudinal study for assessments only. Both index and network participants~     will be assessed at baseline, 6, and 12-months.~      The specific aims of the proposed study are to:~        1. Train Black MSM (index participants in the experimental condition) to conduct peer~          health education, to promote VCT and HIV risk reduction among social network members,~          and to recruit social network members for VCT.~        2. Examine changes in HIV risk behaviors and VCT among index participants and their~          network members in the experimental intervention as compared to those in the control~          condition.~        3. Examine mediating effects of social environments (networks, social norms) on HIV risk~          behaviors and VCT, among indexes and network members.~        4. Examine mediating effects of individual level factors (substance use and depression) on~          HIV risk behaviors and VCT among indexes and network members.~   "
95988|NCT01800708|"~     The aim of the present study is to investigate the outcomes of congenital cataract surgery~     when injecting intraoperative intracameral triamcinolone versus the postoperative use of~     oral prednisolone.~      This is a prospective, randomized clinical trial. Sixty children will be submitted to~     congenital cataract surgery younger than 2 years of age. They will be randomly divided in~     two groups. The study group will receive an intraoperative intracameral triamcinolone~     acetonide injection. The control group will receive prednisolone syrup postoperatively. The~     surgical outcomes will be assessed after one year.~   "
95989|NCT01800695|"~     This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with~     glioblastoma multiforme.~   "
95990|NCT01800682|"~     The purpose of this study is to evaluate the dose proportionality of the pharmacokinetics~     (explores what the body does to the drug) of tramadol in healthy adult participants.~   "
95991|NCT01800669|"~     The investigators hypothesize that by adding a patient screening and physician alerting~     module to a computer-based decision support system, the investigators can improve the~     detection and management of legal issues that may affect children's health. this randomized~     controlled trial will place the module in two clinics using the CHICA decision support~     system and compare the rate of detection and resolution of medical-legal issues in those~     clinics compared to two clinics using the CHICA system without the medical-legal module.~   "
95992|NCT01800656|"~     The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy~     interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2)~     safety and feasibility of endoloop assisted snare polypectomy in patients with long-term~     antiplatelet therapy; 3) safety and feasibility of so called ligate and let go approach in~     patients with long-term antiplatelet therapy.~   "
95994|NCT01800630|"~     Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients~     each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation~     (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and~     12 of 4 21-day cycles each to further characterize safety and tolerability.~   "
95995|NCT01800617|"~     The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland~     produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy~     for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a~     synthetic form of T4. T4 is converted into the active hormone T3 in the circulation.~     Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly~     lower than in individuals whose own thyroid gland is functioning normally. Symptoms of~     hypothyroidism have been suggested to occur because of this possible T3 deficiency, although~     this is controversial. Studies of T3, added to or substituted for T4 in traditional~     levothyroxine regimens, have generally not shown any benefit of T3. However, it is still~     possible that no benefit is seen because of the short duration of action or half-life of~     T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite~     multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and~     troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels.~     This study will look at TSH and thyroid hormone levels following a daily dose of a new~     preparation of T3 that may have longer duration of action than liothyronine. This~     preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady~     levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients~     with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels,~     without producing symptoms of too much thyroid hormone. The goal of future studies is to~     test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with~     traditional levothyroxine therapy.~   "
95996|NCT01800604|"~     Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation~     (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been~     little research on how to treat this pain. Different types of treatment that include~     self-hypnosis, education about chronic pain, and learning skills on how to change how a~     person thinks about his/her pain have been used to treat chronic pain in the general~     population. The purpose of this study is to see if these different treatments can help~     decrease pain in people with multiple sclerosis and spinal cord injury, and determine how~     and why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD,~     or LBP, have chronic pain, and be at least 18 years old to participate.~   "
95997|NCT01800591|"~     The goal of this study is to compare a novel approach using financial incentives to changes~     in health benefit design and their impact on employee weight loss.~   "
95998|NCT01800578|"~     the aim of this study was to estimate the relations between Bispectral Index values and~     explicit or implicit memory or dreams during two different minimal alveolar concentration~     (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery~     and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like~     epidural analgesia, the requirement of halogenated volatile anesthetics.~   "
95999|NCT01800565|"~     Precocious puberty (PP) in girls is classically defined by the onset of secondary sexual~     characteristics before eight years of age, but subsequent pubertal maturation can be quite~     varied. In many girls, PP takes a rapid course of progression (rapidly progressive~     precocious puberty; RP-PP) with an early menarche and fusion of the epiphyseal growth~     plates, leading eventually to a reduced final height if not treated. In a subset of girls~     with PP however, the growth rate slows to normal for age, skeletal maturation progresses in~     accordance with chronological age and there is little to no risk of impairment of final~     height (slowly progressive precocious puberty; SP-PP). Other conditions of non-progressive~     PP include premature breast budding and unsustained PP that is characterized by a~     spontaneous regression of sexual precocity. Due to their benign course, slowly progressive~     (SP) PP and other non-progressive forms of PP do not warrant therapy with GnRH agonists.~     Differentiating these forms from RP-PP is therefore essential to prevent unnecessary~     intervention in a population that accounts for at least 50% of girls with PP. A distinction~     between these forms of PP may be difficult on clinical grounds however, since all these~     patients may present initially as isolated breast development.~      The gold standard for the diagnosis of true (central) PP is the measurement of gonadotropins~     following GnRH stimulation test. There is however an overlap between prepubertal and early~     pubertal values and between girls with premature breast budding and progressive PP. It was~     suggested therefore that progressive pubertal development and growth acceleration should be~     documented over a 3- to 6-months period before GnRHa therapy in initiated.~      More than a decade ago several studies demonstrated that urinary gonadotropins are age~     related and significantly increased during puberty. It has been suggested that urinary~     gonadotropins measurements can be used for differential diagnosis of pubertal disorders.~     This is based on the assumption that gradual elevation of nocturnal LH secretion prior to~     and at the onset of puberty can be reflected by first-voided urinary LH (ULH). In this~     prospective study, the investigators aimed to evaluate the value of first-voided ULH~     measurements in predicting pubertal course and differentiating SP-PP from RP-PP, by~     comparison to GnRH-stimulated gonadotropins.~   "
96000|NCT01800552|"~     The purpose of this study is to determine whether commercial ultrasound imaging systems can~     discern normal from infiltrated tissue near a peripheral intravenous site.~   "
96001|NCT01800539|"~     Based on the need to characterize and improve early intervention services for minority and~     under-resourced children with ASD, this study translates a manualized and proven training~     model to examine its impact on the use of evidence-based practices (EBP) by early~     intervention providers, and to examine its relationship to child and family outcomes. By~     highlighting the impact of EBP-focused training on participating providers, children, and~     families, findings of the proposed study have the potential to effect significant change in~     the organization and delivery of early intervention services for minority and~     under-resourced children with ASD.~   "
96002|NCT01800526|"~     Part 1: A pilot study in patients with homozygous S (HbSS) or hemoglobin S with beta zero~     thalassemia(HbS-βo thalassemia), with the aim of examining the effect of intravenous NAC~     treatment on plasma VWF parameters and measures of redox and RBC function.~      Part 2: A pilot study in patients with sickle cell disease admitted to the hospital in~     vaso-occlusive crisis to determine the effects of NAC infusions on plasma VWF parameters and~     measures of redox and RBC function, and on measures of pain and hospital length of stay.~   "
96003|NCT01800513|"~     This proposed research is a single center, prospective, single-blinded, randomized~     controlled trial, designed to evaluate IVF pregnancy outcomes following endometrial injury~     in 254 patients with implantation failure. Patients will be identified during their work-up~     and treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove~     patients are eligible for the study. The investigators hypothesize in patients with one or~     more previous failed day 5 blastocyst transfers, injury to the endometrium via endometrial~     biopsy will improve clinical pregnancy outcomes compared to controls.~   "
96004|NCT01800500|"~     This randomized clinical trial studies interest in smokeless tobacco product as a~     substitution for cigarettes in current smokers. Use of smokeless tobacco products may help~     people stop smoking. Measuring use of other sources of nicotine for cigarettes under a~     variety of different conditions may help determine whether and how much smokers are willing~     to use substitutions~   "
96005|NCT01800487|"~     Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed~     its efficacy to decreased serum alanine transaminase enzyme in animal models from recent~     study. No confirmed this efficacy was performed in human.~      A prospective, double-blind, placebo-controlled trial was carried out according to Good~     Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent~     hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the~     study. New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases,~     current alcohol drinking more than 20 g/day, regular use of herbal or other potential~     hepatotoxic drugs are excluded. Patients are treated with a standard regimen of four~     anti-tuberculosis therapy. They will randomize to receive either placebo or silymarin (140~     mg) thrice daily. Liver function test (LFT) and clinical changes are assessed at 2- and~     4-week after initiation of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is~     defined as: i) a rise of alanine aminotransferase (ALT) to 2 times above normal upper limit,~     or ii) an elevation of total bilirubin more than 2 mg/dl with or without ALT elevation. The~     study endpoints are the level of ALT by week 4 and the number of patients who developed~     atb-DILI.~      Statistical analysis is used to compare the differences in ALT and number of atb-DILI~   "
96006|NCT01800474|"~     A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice~   "
96007|NCT01800461|"~     Participation in valued activities following stroke is a recognized problem. Efficient and~     effective interventions to address this problem have not yet been established although the~     literature provides direction as to the needs of stroke survivors and important parts of~     interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging~     approach to enabling occupational performance or participation in valued activities that~     includes these important parts of interventions. The primary goal of OPC is ability and~     satisfaction with participation in chosen activities, while promoting a client's ability to~     address future problems with participation. OPC has been successfully used with parents and~     their children in addressing problems with participation.~      OPC has not been explored among adults who have experienced a stroke. For this study~     OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential~     effectiveness for increasing participation as well as how feasible and acceptable the~     research methods are. Sixteen participants who receive OPC-Stroke will be compared with~     sixteen who do not using measures of participation, goal achievement, well-being,~     self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about~     their experience of the treatment.~   "
96008|NCT01800448|"~     For critically ill patients, it is important to know when to liberate them from mechanical~     ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the~     progressive decrease of the amount of support that a patient receives from the mechanical~     ventilation). It is well recognized that prolonged ventilation and weaning harms patients~     and introduces significant increased costs to the health care system. The investigators~     objective is to improve the safety of removal of life support in critically ill patients by~     harnessing information from two new technologies; NM3 and Nexus device. In particular, the~     investigators are interested in the patterns of variation of respiratory and cardiac signals~     from the NM3 device, as well as monitor skin conductance with the Nexus device. The~     combination of these measures has not yet been investigated to date, and could represent a~     novel set of measures that can be used to help physicians better manage critically ill~     patients. The current standard of care dictates that once a patient is considered as a~     candidate for withdrawal from ventilation, a spontaneous breathing trial (SBTs) is~     performed, where the degree of ventilator support is decreased, and their response is~     observed to help predict if they will tolerate extubation.~      Health is associated with a high degree of variation of physiologic parameters such as heart~     rate and respiratory rate, and illness & stress are associated with a loss of variability.~     The analysis of variability of biological signals measures the degree of fluctuations~     present over time. Previous studies have demonstrated that changes in variability (generally~     decreases) are observed in illness states, and the degree of this change correlates with~     illness severity. Several studies have reported that reduced heart or respiratory rate~     variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently,~     variability analysis has traditionally been done only on heart rate (HRV), derived from~     analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The~     investigators aim to apply variability analysis to the respiratory and cardiac signals which~     represent a rich novel set of muti-organ variability measures whose utility in managing~     extubation and ventilator weaning has not been investigated to date.~   "
96009|NCT01800435|"~     Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII~     (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients~     with high titer inhibitors. However, management of bleeds in these patients can be~     challenging due to variation in response and lack of standardized methods to monitor the~     effect. We hypothesized that significant increase in whole blood clot stability could be~     achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin~     generation remains unaffected. In this prospective crossover study the effect of aPCC and~     rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were~     studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA),~     respectively. In addition, the risk of thrombosis and disseminated intravascular coagulation~     (DIC) was assessed.~   "
96010|NCT01800422|"~     The purpose of this study is to determine whether or not the medication that blocks the~     effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of~     breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a~     medication that works against the hormone, progesterone. The researchers in this study would~     like to compare changes in breast cancer cells of women who have taken CDB-4124 prior to~     surgery to those from women who have taken a placebo pill prior to surgery.~   "
96011|NCT01800409|"~     Compromised respiratory function as a result of tetraplegia is a leading cause of~     rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal~     muscles has previously been used to improve the respiratory function of tetraplegic patients~     in the chronic stage of injury. In this study the investigators aim to evaluate the optimum~     protocol for the use of electrical stimulation of the abdominal muscles to improve the~     respiratory function of the tetraplegic population. The investigators also aim to~     investigate whether abdominal functional electrical stimulation combined with mechanical~     insufflation-exsufflation can be used to help further improve the respiratory function of~     the tetraplegic population.~   "
96071|NCT01799616|"~     The purpose of this study is to determine whether pamidronate is effective and~     well-tolerated in the treatment of painful degenerative disk disease, also known as Modic~     type 1 changes~   "
96012|NCT01800396|"~     Background: The incidence of gastrointestinal infections is very high. In Western countries~     at least 30% of the population suffers from at least one food-borne infection per year.~     Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention~     of infections. One of the possibilities is to strengthen human resistance to gut infections~     by consumption of milk ingredients.~      Aim: To study whether a milk protein concentrate rich in phospholipids improves the~     resistance of humans to enterotoxigenic E. coli (ETEC).~      Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks~     intervention with a milk protein concentrate rich in phospholipids in healthy subjects of~     18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate~     rich in phospholipids or placebo group (n=30 per group). Subjects will be instructed to~     maintain their usual pattern of physical activity and their habitual food intake, but to~     standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects~     will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A;~     collection NIZO food research; dose will be 1010 CFU). Before and after infection, an online~     diary will be kept to record all food and drinks consumption (2x2 days) to assess the~     habitual dietary intake. The diary will also be used for daily recording of bowel habits and~     frequency and severity of gastrointestinal complaints.~      The following biological samples will be collected: 4x10 ml venous blood, a single fecal~     bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and~     the fecal samples are collected to quantify several infection- and immune system markers and~     to verify dietary calcium intake. Saliva is sampled three times before and after infection~     to quantify immune system markers.~      Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output~     per day).~      Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores~     and gastrointestinal complaints, relative fecal wet weight.~   "
96013|NCT01800383|"~     Posttraumatic stress disorder (PTSD) is a common and debilitating neuropsychiatric disorder~     in which an acute fear response to a traumatic event does not abate. This failure to recover~     from trauma is thought to be due at least in part to a deficit in learning not to fear~     situations and stimuli previously associated with the trauma (i.e., specifically due to a~     failure of extinction recall). Pavlovian fear conditioning can be simulated and measured~     experimentally in humans using a 2-day fear conditioning paradigm developed by our group,~     wherein conditioning and extinction learning phases are conducted on Day 1, and extinction~     recall is tested on Day 2.~      Recent functional magnetic resonance imaging (fMRI) evidence indicates that PTSD is~     associated with hyper-responsivity of the insular cortex and hyporesponsivity of the~     ventromedial prefrontal cortex (VMPFC) during exposure to fear-inducing stimuli, consistent~     with altered excitability of brain regions mediating fear conditioning and extinction. As~     the brain's principal inhibitory neurotransmitter, GABA exerts a prominent role in~     modulating neuronal excitability. Interestingly, there are reports that adjunctive treatment~     with GABA-enhancing antiepileptics is efficacious in PTSD. There is also evidence, albeit~     inconsistent, that lower serum GABA levels predict a more chronic course of the illness.~     However, it is unclear whether serum levels accurately reflect brain GABA, which may~     contribute to inconsistency of serum findings. Moreover, it is possible that GABA~     alterations may vary in their presence, nature and significance across brain regions~     implicated in PTSD. The proposed study will examine the relationship of PTSD symptoms and~     behavioral fear conditioning deficits with regional brain gamma-aminobutyric acid (GABA)~     using proton magnetic resonance spectroscopy (1H-MRS).~      We have the following aims and hypotheses:~        1. To determine whether GABA alterations are associated with the categorical diagnosis of~          PTSD and not merely exposure to trauma. It is hypothesized that PTSD will be associated~          with higher GABA in VMPFC and lower GABA in the right insula.~        2. To determine whether GABA levels are significantly associated with dimensional measures~          of PTSD symptom severity and individual symptom dimensions. It is predicted that higher~          GABA in the VMPFC and lower GABA in the right anterior insula will be associated with~          greater total symptom severity.~        3. To determine whether GABA in VMPFC and right anterior insula are significantly~          associated with measures of extinction recall failure and anxiety sensitivity in PTSD.~          It is hypothesized that VMPFC GABA will be positively correlated with skin conductance~          response to a conditioned stimulus that had previously been extinguished and insula~          GABA will be negatively correlated with anxiety sensitivity.~   "
96014|NCT01800370|"~     Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted~     in each burst. Stress-associated mechanisms introduced by acute illness and chronic disease~     decrease LH and Te secretion further. A major unresolved issue is whether the aging process~     heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te~     secretion. This study will assess LH and Te secretion in response to a physical stressor~     (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in~     healthy men ages 18-80 yr.~   "
96015|NCT01800357|"~     This study seeks to evaluate the efficacy and safety of mildronate injection in treating~     acute ischemic stroke~   "
96016|NCT01800344|"~     The study compares the incidence of pharyngolaryngeal complications in patients managed with~     either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a~     LMA, in ambulatory surgery patients.~   "
96017|NCT01800331|"~     In Canada, the number of obese children and adolescents has increased tremendously.~     Interventions addressing diet and physical activity have been successful in the short-term.~     However, a great number of individuals have difficulties maintaining achieved weight loss~     and returning to treatment sessions.~      New technology interventions, through the web or delivered trough Personal Digital~     Assistants (PDAs) (e.g. iPhone or Blackberry), are increasingly being used in health~     interventions. PDAs have emerged as appealing in health interventions as they are easily~     accessible and their interactivity makes them well suited to promote long-term engagement in~     behaviour change interventions.~      This study will look at the utility of supplementing a family-based lifestyle program for~     overweight and obese adolescents (Shapedown BC) with a PDA intervention (Text2bHealthy)~     focussing mainly on physical activity, sedentary behaviours, and dietary intake to maintain~     treatment success by improving self-management skills. Adolescents and will receive~     Text2bHealthy for 3-months after 3 months participation in the Shapedown BC program.~      Results from this study will provide needed information on how to improve treatment~     adherence and maintenance outcomes through the use of innovative methods and will ultimately~     contribute to the improvement of long-term outcomes in obesity treatment.~   "
96018|NCT01800318|"~     The purpose of the study is to determine whether noninvasive electrical stimulation at~     acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants~     during invasive procedures.~      The investigators hypothesize that:~        -  Gentle noninvasive electrical stimulation at selected acupuncture points and/or oral~          use of 24% sucrose with pacifier will reduce the newborn infant's responses to~          heelstick pain, as measured by the Premature Infant Pain Profile (PIPP), heart rate~          variability, duration of crying, and salivary cortisol levels.~        -  The effects of combined therapies will be additive.~        -  The analgesic effects of NESAP and/or sucrose will continue for the duration of the~          heelstick, reflected by the first two minutes of heelstick and the first two minutes of~          recovery.~   "
96019|NCT01800305|"~     The object of this randomized, parallel, positive controlled study is to explore the~     pharmacokinetics and pharmacodynamics profile of the test drug after single-dose~     subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose~     subcutaneous administration, by assessing plasma concentration of the drug and the~     reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous~     administration, evaluate the security and tolerability of the test drug in healthy subjects,~     and provide sufficient information for dose selection in the future phase II and III study.~   "
96020|NCT01800292|"~     The purpose of this study is to determine if patients with pulmonary hypertension and mildly~     elevated heart pressure known as PCWP will exhibit different patterns on echocardiography~     and that these patterns will predict treatment response to sildenafil, a drug given for this~     condition.~   "
96022|NCT01800266|"~     The primary goal of this study is to examine the impact of varying supervision strategies on~     clinician fidelity and client outcomes in a community-based setting. Prior research has~     established that training approaches that do not include a period of intervention-specific~     supervision or consultation are ineffective and that implementation efforts that include~     only an initial period of supervision show an eventual attenuation of gains in knowledge and~     fidelity in practice. Ongoing supervision may be required for effective and sustained~     implementation of evidence-based practices (EBPs) in community-based settings. However,~     supervision is one of the least investigated aspects of training. Gold standard elements~     of supervision from efficacy trials include review of sessions, standardized procedures for~     monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral~     rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in~     community-based settings is unknown.~      There are a growing number of national and statewide efforts to increase the reach of EBPs~     through dissemination and implementation initiatives. There are 18 statewide initiatives to~     implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma~     exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those~     for other EBPs, include a specific focus on supervisors. However, the limited scientific~     literature provides very little guidance for these efforts. Aims of the current trial~     include 1) studying supervision with existing implementation supports; particularly presence~     of gold standard elements; 2) evaluating the effects of varying supervision strategies on~     fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on~     the relationship between supervision type and client outcomes. We propose a two-phased,~     within-subjects and between subjects design. In Phase I (9 months), we examined supervision~     with implementation support. In Phase II (30 months), we will examine two specific~     supervision conditions, each including varying EBP supervision elements.~   "
96023|NCT01800253|"~     The study proposes to investigate whether acute total deprivation affects metabolism as~     measured through blood and peripheral tissues. Its aim is also to investigate how acute~     total sleep deprivation affects neurodegenerative markers, as well as hormones, memory~     performance and aspects of appetite regulation.~   "
96024|NCT01800240|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone~     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals~     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
96025|NCT01800227|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone~     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals~     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
96026|NCT01800214|"~     The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has~     intensified efforts to use brain imaging more effectively for diagnosis and monitoring of~     dementing illnesses. There is also emerging awareness of the destructive interplay between~     AD and Cerebrovascular Disease (CVD) in our aging population; both disorders share common~     vascular risk factors and may respond to similar prevention treatments. Brain mapping~     techniques capitalize on the fact that different neurodegenerative diseases target~     particular brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic~     Resonance Imaging (MRI) using computerized analysis.~      This ongoing study applies advanced MR imaging analysis, genetic testing and standardized~     cognitive and functional assessments done at yearly intervals to measure and monitor~     longitudinal change in patients with AD, vascular and other neurodegenerative diseases and~     potentially to measure modifying effects of emerging therapies. Over 1000 patients (Mild~     Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and~     125 normal elderly have already been enrolled, with 150 autopsies.~      This study utilizes specialized imaging analysis software packages to reliably quantify~     brain tissue volumes and small vessel disease, the most common type of CVD. Results from~     this study will help to improve diagnosis, to customize treatment, and to better monitor~     disease-modifying therapies currently under investigation should they become applicable to~     everyday practice.~   "
96027|NCT01800201|"~     The goal of this proposal is to test the implementation of an innovative approach to~     improving health and lowering cost for a high risk population of patients with acute~     myocardial infarction (AMI) immediately post-hospitalization. The investigators will~     implement a new service delivery approach that will provide a foundation for a payment~     system that rewards keeping high-risk patients healthy and that deploys technology and a~     health care workforce of the future to implement prevention, care coordination, care process~     re-engineering, team-based care, and the use of data to support new care delivery models.~     This program is focused on coronary artery disease (CAD), but we expect that a successful~     implementation of this model will demonstrate a sustainable pathway to the three-part aim~     not just for CAD, but for many other conditions whose outcomes are highly sensitive to~     post-discharge coordination.~      This proposal has three main principles:~        1. Principles of behavioral economics that have been developed, refined, and tested over~          the past decade offer practical insights into health behaviors that were previously~          unavailable and are not reflected in existing care models.~        2. New technology, typically wireless devices for pill bottles, and mobile telephones,~          make engagement with patients substantially easier and more immediate now than ever~          before.~        3. While randomized clinical intervention trials provide exceptional confidence of~          comparative effectiveness in narrow interventions, they are slow and rigid and dont~          reflect the urgency that health care transformation currently requires. Principles of~          rapid cycle innovation are gaining acceptance as an alternative to or supplement of~          these traditional methods in supporting evidence for implementation success.~   "
96028|NCT01800188|"~     Disturbed glucose metabolism is a common feature of patients with end-stage renal disease~     (ESRD). Several hormones responsible of a stable blood glucose including insulin, glucagon,~     and the gastrointestinal insulinotropic hormones Glucagon-like Peptide-1 (GLP-1) and~     Glucose-dependent Insulinotropic Peptide (GIP) are elevated in patients with ESRD. These~     hormones are all medium sized peptides which theoretically makes them removable during high~     efficient hemodialysis. A significant removal could have consequences for the treatment of~     patients with diabetes and ESRD.~      The purpose of this study is to determine whether insulin, glucagon, GLP-1 and GIP are~     cleared during high efficient hemodialysis and hemodiafiltration. The investigators~     hypothesize that a significant amount of these hormones is removed during hemodialysis and~     to a larger extend during hemodiafiltration.~   "
96072|NCT01799603|"~     The purpose of this study is to investigate the effect of food on the pharmacokinetics~     (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult~     male participants.~   "
96029|NCT01800175|"~     The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug~     when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in~     order to assess retention and replacement of the OTX Punctum Plug for this duration. At the~     Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial~     OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180~     and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX~     Punctum Plug is removed.~   "
96030|NCT01800162|"~     This is a randomized controlled trial to compare three currently available management~     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes~     them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a~     confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed~     by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic~     pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. Randomization will~     be 2:2:1 into these three arms. After randomization, they will be followed and treated~     clinically as is indicated by the progression of their condition. Primary outcome measures:~     uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions,~     treatment complications, health-related quality of life, financial costs, future fertility,~     and patient's preferences.~   "
96031|NCT01800149|"~     Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a~     collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive~     adult patients, requiring tooth extraction in the frontal area of the upper and lower arch~     maxilla (from second premolar to second premolar), will be enrolled into the study.~      After tooth extraction, sockets will be randomized and divided into two groups: in Group A~     the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted~     with BioOss granules (small granules). The graft will be covered with porcine collagen~     membrane (BioGide). Then, the flap will be sutured.~      MEASUREMENTS:~      The end of the study will be fixed at the 6 months evaluation after tooth extraction.~     Impression will be taken before tooth extraction and after 6 months in order to create cast~     models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal~     dimension of the soft tissues will be measured. One measurement per tooth will be recorded,~     at T0 (before extraction) and T2 (after 6 months).~      A 3D radiological image, using the CBCT technique, will be obtained at the end of the~     surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition~     will be performed in order to measure hard tissue remodelling.~      After six months (T6), a a biopsy specimen will be also harvested for that augmented~     extractions sockets on which an implant installation has been previously planned.~   "
96032|NCT01800136|"~     The aim of this study is to compare analgesic efficacy of two non invasive techniques based~     on motor cortex stimulation in neuropathic pain patients. High frequency repetitive~     transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to~     induce an analgesic effect significantly different from placebo; this effect is clinically~     useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct~     current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its~     efficacy in neuropathic pain has been not yet established. The investigators propose to~     compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using~     HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be~     performed before and after the five sessions of rTMS and tDCS, in order to reveal the~     potential plasticity induced within motor somatotopic map of the primary motor cortex.~   "
96033|NCT01800123|"~     There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital~     signs or lactatemia have failed to prove good predictive value.~      The main acute self poisoning complication is decreased consciousness level with consequent~     increased risk of hypoxemia and aspiration pneumonitis.~      Several clinical studies have recently shown that EtCO2 monitoring can be valuable in~     procedural sedation in the emergency department. It is able to predict hypoxemia before any~     SaO2 decrease and any complications related to these procedures.~      We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring~     in the ED.~   "
96034|NCT01800110|"~     Many medicinal effects of Pomegranate juices are already known. Mainly known for its~     anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice.~      Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood~     and blood cells were published.~      In addition, published studies have demonstrated the anti-oxidant activity which inhibit the~     development of atherosclerosis and stroke, even in patients with diabetes, and its effect of~     decreasing systolic blood pressure in patients with systemic hypertension.~      The purpose of the work is to examine the effect of drinking pomegranate juice on the level~     of anti-oxidants in human breast milk.~   "
96035|NCT01800097|"~     This study is an investigator initiated placebo controlled double blinded trial. The~     hypothesis is that treatment with modafinil positively will affect behavioural and cognitive~     rehabilitation after stroke, causing the treatment group to experience decreased fatigue,~     increased endurance, improved skills of sustaining attention and faster reaction times. The~     cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and~     better physical performances due to a higher level of physical activity.~   "
96036|NCT01800084|"~     The main objective of this study is to demonstrate the non-inferiority of SPECT image~     quality (as measured by the signal / noise ratio) obtained by ASIR reconstruction of~     very-low-dose CT acquisitions versus the quality of those obtained by filtered back~     projection (FBP) of low-dose CT acquisitions.~      The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP~     expected is between 5 and 6.~   "
96037|NCT01800071|"~     This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine~     that has already been studied in small number of cancer patients.~      The vaccine is designed to boost a patient's immunity against a common virus. The virus is~     called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly~     found in nasopharyngeal cancer cells.~   "
96038|NCT01800058|"~     The detection and quantification of Circulating tumor cells CTCs in peripheral blood of~     patients with prostate adenocarcinoma may be useful at least for:~      Getting a correct stratification of patients with high-risk prostate cancer (PCa).~      Set the prognosis at baseline. Evaluate the response to different treatments (predictive~     value and monitoring).~      Establish individualized therapies.~   "
96040|NCT01800032|"~     This prospective pilot study is designed to provide preliminary data on the use of~     Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in~     patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma~     (PN).~      Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12~     months, unless more frequent imaging is clinically indicated. Subjects and their family~     caregivers will also undergo serial interviews and complete questionnaires related to the~     psychosocial aspects of NF1.~   "
96041|NCT01800019|"~     The objectives of this trial are:~      Primary objectives:~        1. To determine among HIV+ individuals whether varenicline or NRT is more effective at~          helping individuals remain abstinent from smoking tobacco.~        2. To determine among HIV+ individuals whether varenicline or NRT has the lowest~          side-effect profile.~        3. To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking~          cessation drug therapy, improves smoking cessation rates compared to smoking cessation~          drug therapy alone with usual care.~      Secondary objective:~      1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit~     depressive symptoms.~      Hypothesis:~      That varenicline will result in higher quit smoking rates and that NRT will result in a~     lower side effect profile. Further, the HIV tailored quit smoking intervention will result~     in higher rates of smoking cessation over and above the pharmacological treatment alone. And~     finally, varenicline will be safe to use for HIV + individuals who exhibit depressive~     symptoms.~   "
96042|NCT01800006|"~     This international study is a prospective noninterventional observational cohort study of~     patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine~     treatment conditions to prevent stroke or non-central nervous system systemic embolism.~     Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in~     case of therapy was discontinued earlier than 12 months. Serious adverse events will be~     followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented~     for each point in time they were measured.~   "
96043|NCT01799993|"~     To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400~     mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System~     (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal~     saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and~     mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint~     objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized~     placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on~     ventilation, and the days in the intensive care unit (ICU).~   "
96044|NCT01799980|"~     This study will compare two different methods of staging lung cancer to determine whether~     endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good~     diagnostic yield in detecting lung cancer, when compared to current methods of a staging~     bronchoscopy and cervical mediastinoscopy.~   "
96045|NCT01799967|"~     This study will assess short and long term outcomes of individuals undergoing minimally~     invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to~     questionnaires on an annual basis evaluating quality of life and functionality following~     MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health~     outcomes.~   "
96046|NCT01799954|"~     This study will evaluate the safety of and the body's immune response to experimental HIV~     vaccine regimens using different vaccine priming combination, and boosting with the vaccines~     NYVAC and AIDSVAX® B/E.~   "
96047|NCT01799941|"~     The objectives of the study are to evaluate the safety, tolerability, and effectiveness of~     NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment~     of PBA in patients with prevalent conditions such as dementia, stroke and traumatic brain~     injury over a 12 week period.~   "
96048|NCT01799915|"~     Synucleinopathies are a group of rare diseases associated with worsening neurological~     deficits and the abnormal accumulation of the protein α-synuclein in the nervous system.~     Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present~     clinically with slowness of movement, coordination difficulties or mild cognitive~     impairment. Development of these features indicates that abnormal alpha-synuclein deposits~     have destroyed key areas of the brain involved in the control of movement or cognition.~     Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with~     Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA).~      However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the~     brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms~     of autonomic impairment (unexplained constipation, urinary difficulties, and sexual~     dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic~     hypotension) may be the only clinical finding. This pre-motor autonomic stage suggests~     that the disease process may not yet have spread to the brain.~      After a variable period of time, but usually within 5-years, most patients with abnormally~     low blood pressure on standing develop cognitive or motor abnormalities. This stepwise~     evolution indicates that the disease spreads from the body to the brain. Another indication~     of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem~     that occurs when the lower part of the brain is affected, may also be the first noticeable~     sign of Parkinson disease.~      The purpose of this study is to document the clinical features and biological markers of~     patients with synucleinopathies and better understand how these disorders evolve over time.~     The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA)~     and those believed to be in the pre-motor stage (with isolated autonomic impairment and/or~     RBD). Through a careful series of follow-up visits to participating Centers, we will focus~     on finding biological clues that predict which patients will develop motor/cognitive~     problems and which ones have the resilience to keep the disease at bay preventing spread to~     the brain. We will also define the natural history of MSA - the most aggressive of the~     synucleinopathies.~   "
96049|NCT01799902|"~     This study is a non interventional study where no investigational medicine is provided.~     Procedures and examination will follow the institution standard of care practice. The~     therapeutic approach will not be decided in advance by the protocol or influenced in any way~     by the protocol.~      After standard evaluation the investigator will decide the treatment strategy and upon~     eligibility criteria met will propose subject to participate to the study. Informed consent~     will be collected for all subjects.~      The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow~     up).~      During all observational visits (V1, V2 and V3) the patient will complete the I-PSS~     (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL)~     questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual~     Analogue Scale (VAS).~      The patient will be asked to complete a voiding diary the first 3 days after Visit 1~     (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.~      Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and~     Trans Rectal Ultra Sound data will be collected only if available.~      During all observational visits (V1, V2 and V3) the investigator will complete the~     assessment of treatment benefit and satisfaction using a VAS.~   "
96050|NCT01799889|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of~     entospletinib. Participants with the following relapsed or refractory hematologic~     malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic~     leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL),~     follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including~     lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic~     lymphoma [SLL], or marginal zone lymphoma [MZL]).~   "
96051|NCT01799876|"~     The purpose of this study is to assess the potential benefit of enhancing knee surgery for~     cartilage injury using some of the patient's own cells, taken from fat tissue, that may be~     able to help cartilage to regenerate.~   "
96052|NCT01799863|"~     The purpose of this study is to evaluate the evolution of the symptoms of acute viral~     conjunctivitis using preservative free ketorolac trometamol 0.45% associated with~     carboxymethylcellulose compared with isolated use of preservative-free artificial tears.~   "
96053|NCT01799850|"~     Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and~     needle biopsies of muscle will quantify changes in any of seven different glucose transport~     proteins in muscle.~   "
96054|NCT01799837|"~     The objective of this proposal is to collect pilot data to characterize the binding of~     [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD).~     Approximately two hundred thousand veterans will be returning stateside upon the end of~     combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war~     veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care.~     Little is known about the dysregulation of PTSD veteran's neurochemical state including the~     noradrenergic system which plays a primary role in memory and stress response. This includes~     heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic~     system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have~     projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is~     responsible for regulating and terminating noradrenergic transmission, and is a specific~     marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET~     protein. An unresolved problem in studying the noradrenergic system is identification of~     suitable radiopharmaceutical to non-invasively measure alterations in the density of NET.~     The investigators propose to address this challenge by using positron emission tomography~     (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans~     with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an~     up-regulation of NET in the locus coerulues resulting from hyperactivity of the~     noradrenergic system compared to healthy controls. Through a series of experiments, the~     investigators will determine the in vivo binding characteristics of [11C]MENET. The~     investigators will use this information to optimally design an experimental protocol to~     measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD.~     The aims of this proposal are: 1) Measure the uptake kinetics and whole brain distribution~     of [11C]MENET in combat-exposed veterans with PTSD and healthy controls, 2) Develop a~     quantitative kinetic model of [11C]MENET uptake to calculate the NET availability in brain.~     The subjects undergoing imaging in this work will be recruited by Dr. J. Douglas Bremner~     (Co-Investigator) at Emory University and Atlanta Veteran Affairs Hospital. Our long-term~     goal is to develop a longitudinal study framework to assess the NETs dysregulation during~     onset of PTSD as well as its transition to chronic lifetime PTSD.~   "
96055|NCT01799824|"~     The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary~     axillary hyperhidrosis.~   "
96056|NCT01799811|"~     The objective Study is to evaluate the short- and long-term clinical outcomes of patients~     receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open~     bypass conduit to assess if there is a quantifiable correlation to time of placement as a~     primary bypass graft and improved long-term clinical outcomes of patients with critical limb~     ischemia (CLI).~   "
96057|NCT01799798|"~     Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in~     children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis~     imperfecta. Efficacy will be assessed by DXA measurements at the lumbar spine of the areal~     bone mineral density (BMD) which is the most frequently used parameter in trials~     investigating osteoporosis.~      The hypothesis of the study is:~      Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast~     maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could~     be increased during a 36 week treatment course with denosumab measured after 48 weeks.~   "
96058|NCT01799785|"~     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an~     impact or morbidity and mortality. Regular aerobic exercise training is a proven effective~     therapy to improve exercise capacity in healthy and clinical populations. the effect of this~     training has not yet been evaluated in cirrhosis. The safety of this intervention also~     requires further study. Using a randomized controlled design, the investigators aim to~     conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise~     training on aerobic capacity.~   "
96059|NCT01799772|"~     Patients who undergo a replacement of their knees are generally older adults who have dealt~     with severe knee pain and joint degeneration for a long time. The majority of them are~     sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and~     helps patients to live a better life. However, after the surgery, some patients have~     difficulty performing basic activities such as walking, or going up-down stairs, and the~     majority remains sedentary and gain weight. These combined problems leave patients at risk~     of worsening their health. Therefore, a treatment that takes care of all these combined~     problems is needed. We propose an all-inclusive treatment, called comprehensive behavioral~     intervention (CBI) that intends to improve the long-term effects of exercise programs. The~     CBI combines exercise program with promotion of physical activity, orientation on healthy~     nutrition, and an education approach that promotes self-initiative towards healthy habits.~     The overall aim of this proposed study is to test how patients post TKA will like the CBI~     program, how safe the program is, and adapt the program as needed for better acceptability.~     We believe the CBI will be safe, well tolerated, and will improve the ability of patients to~     perform physical tasks. We also believe the program will increase the amount of physical~     activity, will promote maintenance of healthy weight, and will help the patients to obtain~     and maintain healthy habits. In this study subjects will be selected by a flip of a coin to~     receive either our CBI program or a more traditional exercise program. Subjects will be~     tested before and after the treatments. Our measures of main interest are how well subjects~     move around and how physically active they are. We are also interested on the effect of the~     interventions on body weight, blood pressure, eating habits, and general health. The team of~     researchers for this study includes several disciplines. The proposed study will defend the~     need for a larger study that can have a very important impact on the public health of~     patients post TKA. The reason for the public health impact is if the physical limitations~     experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by~     increasing physical activity and promoting healthy weight, it may improve general health and~     prevent chronic diseases. Last, developing educational intervention that promotes~     self-initiative will result in long-term health benefits post TKA.~   "
96073|NCT01799590|"~     The purpose of this study is to evaluate the safety and efficacy of topiramate in~     participants with migraine (type of severe headache that occurs periodically and is often~     associated with nausea, vomiting and constipation or diarrhea) who completed the~     JNS019-JPN-02 study.~   "
96074|NCT01799577|"~     This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking~     Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic~     tasks in an experimental model.~   "
96164|NCT01798381|"~     The aim of this project is to investigate the effect of a dietary supplementation with~     essential fatty acids in adults on cognitive functions related to attention and impulse~     control in the general population and in individuals with a diagnosis of attention deficit~     hyperactivity disorder (ADHD).~   "
96060|NCT01799759|"~     The proposed study is a continuation of a randomized, controlled pilot effectiveness trial~     conducted in schools wherein the feasibility and completion of the trial by parents and~     children will now additionally be examined in after school and YMCA connected programs.~      The intervention for this study is Project FUN and Project FUN with Parents. Project FUN is~     an 8 module online program for children in 4th through 8th grade. Project FUN with Parents~     is a 6 module online program for their parent.~      Children and parents will be recruited through the afterschool and YMCA connected programs.~     Those agreeing to participate will be randomly assigned to a first intervention or second~     intervention session (waiting list control group). Surveys and measures will be collected~     for everyone pre-intervention, after the first session completion and after the second~     session completion to create a waiting list control group.~      Hypothesis 1: Body composition and dietary fat of children who complete Project FUN and have~     a parent complete Project FUN with Parents will be lower on completion than children who~     only complete instruments.~      Hypothesis 2: Fruit and vegetable intake, physical activity and fitness of children who~     complete Project FUN and have a parent complete Project FUN with Parents will be greater on~     completion than children who only complete instruments.~   "
96061|NCT01799746|"~     In a controlled exposure setting, the study's goal is to determine the acute effect of~     diesel exhaust (DE) inhalation on airway inflammation and hyperresponsiveness (AHR) in~     subjects with mild to moderate stable asthma, using non-invasive measures.~   "
96062|NCT01799733|"~     The primary aim of this study is to examine the effects of co-administered wake therapy~     followed by light treatment on mood, and secondarily on circadian rhythms, to test the~     hypothesis that critically-timed chronotherapy improves mood by correcting phase~     disturbances in melatonin and sleep in women with Premenstrual Dysphoric Disorder.~   "
96063|NCT01799720|"~     The oxidation level of unsaturated fatty acid supplements commercialized in capsules could~     be a serious problem for manufacturers and a risk to consumers; health by ingesting~     substances whose effects are not desired. Therefore, the main objective of this paper is to~     analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the~     lipid profile of women who consume these supplements. For this purpose the investigators~     have designed a single-blind, parallel-groups, randomized controlled trial. Finally, 52~     women between 25 and 75 years old were randomly distributed into three groups: (1) took 2~     capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2)~     took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet~     and (3) no capsules, only received the diet. There was a 30 days follow-up . All groups~     followed a low cholesterol diet. Circulating glucose, total cholesterol, triglycerides and~     glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.~   "
96064|NCT01799707|"~     Importance: Visual field loss after retinal damage in glaucoma is considered irreversible~     and methods are needed to achieve vision restoration. Behavioral vision restoration training~     (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise~     such a method.~      Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT~     by daily one hour training for 3 months improves detection performance in perimetry compared~     to a vision discrimination task in the intact visual field sector.~   "
96065|NCT01799694|"~     The purpose of this study is to evaluate the feasibility and security of the autologous~     e-ASC for the urinary incontinence after a radical prostate cancer surgery~   "
96066|NCT01799681|"~     To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be~     effective in improving balance performance, physical functions, gait parameter, balance~     confidence, health-related quality-of-life, disease-specific motor performance and~     fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.~   "
96067|NCT01799668|"~     The research will examine psychotherapists' preferences for theoretical client~     characteristics, such as age, gender, personality characteristics and symptoms. The research~     will also examine the preferences' influence on the therapeutic alliance, from the~     therapist's and the client's point of view.~   "
96068|NCT01799655|"~     Cardiovascular disease is the most common cause of mortality and morbidity worldwide.~     Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk~     factor for cardiovascular disease. Therefore, there is an increasing interest to explore the~     mechanism in which vitamin D deficiency affect the cardiovascular system.~      The investigators want to examine the relationship between serum vitamin D levels and the~     coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT)~     to assess thrombin generation in plasma as a measure of overall thrombotic activity, and~     thus to suggest a mechanism that may explain the link between vitamin D deficiency and~     cardiovascular disease.~      Our study population are going to include 100 patients from the internal departments in Emek~     hospital, who present with chest pain but without acute coronary syndrome (ACS). The~     investigators will take blood samples from the subjects to measure the serum vitamin D~     levels and the generation of thrombin. The patients will be divided into four groups~     according to the level of vitamin D to evaluate the effect of vitamin D levels in the blood~     on coagulability and thrombotic activity in these patients.~   "
96069|NCT01799642|"~     Shortness of breath (dyspnea) during exercise is a major source of distress and is a~     commonly reported symptom in patients with cystic fibrosis (CF). Due to the investigators'~     poor understanding of how dyspnea develops, there are no treatments that consistently reduce~     dyspnea in this population. The investigators aim to acquire a more comprehensive~     understanding of the physiological mechanisms of exertional dyspnea in CF patients. This~     study will likely identify an important physiological mechanism of dyspnea in CF and may~     contribute to the development and use of effective treatments to reduce dyspnea in this~     population.~      The central hypothesis is that the impaired tidal volume (VT) response during exercise in~     CF, in the setting of increased ventilatory demand will give rise to different qualitative~     descriptions of exertional dyspnea compared with healthy age and sex-matched controls.~     Specifically, CF patients will select increased work and effort as their dominant~     descriptor of dyspnea up to the VT inflection/plateau. Beyond this point, CF patient's~     dominant descriptor will become unsatisfied inspiration. In contrast, healthy control~     participants will report increased work and effort throughout all phases of exercise and~     will not report unsatisfied inspiration, even after the VT inflection/plateau.~   "
96075|NCT01799564|"~     Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in~     broad areas of the retina. The application of subthreshold micropulse laser spots in healthy~     RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused~     by the disease (ie, the laser may decrease vascular endothelial growth factor and~     RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived~     factor). This may slow or even stop the enlargement of atrophy secondary to GA, and~     therefore, avoid further vision loss.~   "
96076|NCT01799551|"~     Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is~     recommended by the national bodies in many countries in the West. Our group has adapted CBT~     for depression and psychosis in Pakistan for use with local clients. Initial evaluations~     have found that these therapies are effective. However, due to the financial restraints it~     would be useful if the investigators find that brief version of the CBT might be applicable~     and effective in non western cultures. Therefore in this study, the investigators will be~     testing effectiveness of brief version of culturally adapted CBT for depression in a~     randomized controlled trial (RCT) in Pakistan.~   "
96077|NCT01799538|"~     Background:~      - Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost~     exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow~     of air. It is a progressive disease, and in severe cases may require a lung transplant. One~     possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol~     can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to~     compare these methods to see which method best improves lung function in women with LAM.~      Objectives:~      - To see whether a nebulizer or MDI can better improve lung function in women with LAM.~      Eligibility:~      - Women at least 18 years of age who have impaired lung function because of LAM.~      Design:~        -  Participants will be screened with a physical exam and medical history. No lab tests~          will be needed for this study.~        -  Participants will have a 3-day overnight stay at the National Institutes of Health.~          Those who are using long-acting inhalers will have to stop taking these drugs 1 week~          before the study.~        -  Participants will receive either the nebulizer or two or four puffs of the inhaler.~          Four puffs of albuterol is a higher dose than is normally prescribed, and is being~          tested on this study.~        -  Participants will have each treatment around the same time of day on each of the 3~          days. Before and after taking the albuterol, participants will have lung function~          tests.~   "
96078|NCT01799525|"~     Delayed cerebral vasospasm and secondary ischemic infarction are feared complications after~     aneurysmal subarachnoid hemorrhage (aSAH). To date, there is no effective therapy to prevent~     these ischemic complications. The arterial partial pressure of carbon dioxide (PaCO2) is one~     of the main determinants of cerebral blood flow (CBF) in healthy subjects. It is yet largely~     unknown, if and to what extent modulations of PaCO2 can influence CBF in patients after~     aSAH. The trial is a phase 1 study in which the feasibility of hypercapnia in SAH patients~     is tested. PaCO2 is gradually raised to 60 mmHg in 10 mechanically ventilated aSAH patients.~     Cerebral oxygen saturation measured by NIRS and CBF determined by an intracerebral~     thermodilution probe are the primary end points. If the feasibility is confirmed, this trial~     will be followed by a phase 2 dose finding study.~   "
96079|NCT01799512|"~     Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit~     (MICU) and is associated with increased morbidity and mortality. However, randomized~     controlled trials examining the effects of strict glycemic control demonstrated conflicting~     results. A common finding in these trials was the high risk of hypoglycaemia.~      This randomized controlled trial evaluates the impact of real-time continuous glucose~     monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU~     patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.~   "
96080|NCT01799499|"~     This study is a prospective randomized open labeled dose ranging comparative study. Twenty~     four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited~     for the study following the initial diagnostic cystoscopy.~      The investigators believe that this study is of importance on several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. If proved effective, this mode of treatment might save the need for TURBT performance~          and serve as a new mode of tumor ablation.~        3. Even if proved partially effective, this mode of treatment will diminish tumors size~          and/or number, thus enable a more limited TURBT procedure.~        4. This mode of treatment will enable immediate medical attendance to the patient's tumor~          recurrence without the waiting period (resulting from queues in the medical centers)~          for TURBT. This might improve the patient's prognostic outcome.~        5. If this experimental treatment will prove to have a better ablative effect in~          comparison to the standard of care known in the art, this could be translated to a~          better prophylactic effect of tumor recurrence.~        6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor~          recurrence prevention will enable us to reduce adverse effects of higher drug dosage.~   "
96081|NCT01799486|"~     Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its~     worldwide distribution and potential adverse outcome, including cirrhosis, which is a major~     cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can~     alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some~     potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing,~     hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the~     exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis~     are increasing. So when choosing NAs, the potential renal function impairment should be~     considered.~      Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of~     glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of~     patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested~     Telbivudine may have renal protective effects. This effect on patients with HBV-related~     liver cirrhosis has not been studied, which is not clear now.~      This study is a randomized controlled study to prospectively observe Telbivudine's effect on~     renal function, which aims to provide evidence in antiviral treatment for the patients with~     cirrhosis.~   "
96165|NCT01798368|"~     The purpose of this study is to demonstrate that the treatment does not cause any clinically~     significant effects that would put patients at risk.~   "
96082|NCT01799473|"~     This prospective, observational, multi-center, patient registry will follow patients who are~     newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once~     enrolled, the patients' dose and titration will be followed for the first 6 months of~     treatment with Tyvaso.~      A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24~     to review their dose and titration schedule. In addition to patient-reported dosing data,~     some patient demographic information, will be collected by the investigative site at~     Baseline.~   "
96083|NCT01799460|"~     The purpose of this study is to analysis the different genotype in the idiopathic membranous~     nephropathy patients which with different therapeutic outcomes after treated by the~     Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal~     markers to assess appropriate treatment approach and the long-term efficacy.~   "
96084|NCT01799447|"~     Early intervention with the Marte Meo method. Aim to study whether the program have effect~     on:~      Maternal confidence, maternal stress, maternal mood (EPDS), dyadic synchrony (Infant care~     index), and infants social competences (ASQ:SE)~   "
96085|NCT01799434|"~     The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg~     standing and in jump landing, followed by stabilization or side jumps, and to compare~     athletes of different levels with control subjects.~   "
96086|NCT01799421|"~     The purpose of this study is to identify prognostic factors and to develop predictive models~     of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors~     receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of~     10-20%.~   "
96087|NCT01799408|"~     To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot~     preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients~     with osteoarthritis of the knee~   "
96088|NCT01799395|"~     Lung cancer may cause central airway obstruction through several different mechanisms~     (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).~      The aim of the present study is to determine the prevalence at the time of diagnosis, the~     incidence at 1 year from the diagnosis, and the predictors of central airway obstruction~     associated with advanced lung cancer.~   "
96089|NCT01799382|"~     The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples~     can increase the percentage of patients with advanced non-squamous non-small cell lung~     cancer in whom both pathologic subtyping and mutational analysis are obtained.~   "
96090|NCT01799369|"~     Background Surgeons lack a routine, objective evaluation of patient condition after surgery.~     We currently rely on subjective assessment of available patient data. The current scoring~     methods such as Acute Physiology and Chronic Health Evaluation and Physiological and~     Operative Severity Score for the enUmeration of Mortality and morbidity are complex and~     cumbersome and have therefore not been adopted into routine practice.~      The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3~     parameters collected during the operation: lowest heart rate, lowest blood pressure,~     estimated blood loss (Regenbogen et al., Arch Surg 2009).~      Previous validation studies have shown a good correlation between the score and incidence of~     major complications or death occurring within 30 days. For example, 75% patients with a~     score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10.~     To date, the SAS has never been clinically applied and tested in a trial.~      We believe that routine use of the SAS will lead to a reduction in major complications and~     deaths after surgery. We also believe that it will lead to a reduction in the severity of~     the complications.~      This is based on our theory that the SAS eliminates the guesswork. Using this score will add~     objectivity and clarity to clinical decisions that are presently based on clinical instinct~     or 'gut feeling'. The score will more clearly highlight those patients who are at an~     increased risk of developing complications or dying and will flag them up for increased~     monitoring, a higher index of clinical suspicion and a lower threshold for early management~     of problems.~      Primary Aim The primary aim of the pilot is to strengthen the design and assess the~     feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200~     in total. The primary aim of the main study will be to establish if clinical application of~     the SAS leads to a reduction in 30-day post-operative morbidity and mortality.~      Study Design The design of this pilot is the same as what the main trial will eventually be:~     a multicentre single-blind randomised controlled trial (RCT). Current data suggests the~     overall expected major complication or death rate in our target population would be 21%. The~     sample size of the future RCT is therefore estimated to be 986 each group to detect a 5%~     reduction in complications (Significance 0.05%, Power 80%).~      Outcomes Our primary outcome will be major complications or death within 30 days of~     operation. Our secondary outcomes (all within 30 days of operation) will be minor~     complications, primary and secondary critical care admissions and length of stay, duration~     of therapeutic antibiotics, number of additional operations under general anaesthetic to~     treat complications, and overall length of stay.~   "
96091|NCT01799356|"~     We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg~     twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin~     monotherapy, 400 mg once daily, for 14 days~   "
96092|NCT01799343|"~     Pregnant women with pre-eclampsia and growth restricted fetuses often have a reduced~     function of the placenta. This is accompanied by an increased perinatal mortality and~     morbidity.~      By ultrasound it is possible to measure blood flow and vascular resistance in both the fetal~     umbilical cord and in the blood vessels supplying the uterus. A high resistance in these~     vessels occur before the child is severely affected.~      By immersion in water extracellular fluid is redistributed back into the circulation, and~     central blood volume increases. Previous studies have shown that maternal minute-volume~     increases, while blood pressure drops slightly. Also an increased amniotic fluid has been~     recorded. This has been interpreted as an expression of increased renal blood flow.~     Immersion into water could increase blood flow in the vessels supplying the uterus and thus~     increase blood flow to the child.~      The investigators aim to clarify this by examining blood flow and resistance in the blood~     vessel supplying the uterus and in the umbilical cord, while the participant is immersed~     into water. Initially, 25 healthy women with an uncomplicated singleton pregnancy recruited~     from the Department of Obstetrics and Gynaecology: Hvidovre University Hospital, Denmark,~     will be examined. The participant will act as its own control and measurements above water~     and immersed will be conducted at the same study session.~      Ultimately the investigators seek to contribute to a non-invasive option for prolonging~     those pregnancies where the fetus and/or maternal condition requires delivery several weeks~     before term, and where immersion of the pregnant woman in the water a few hours one to~     several times daily, may prolong the pregnancy the required number of hours/days for~     antenatal steroid treatment to be sufficient.~      There are no risks associated with the study and the project team considers it ethical to~     implement this. The study is not supported by pharmaceutical companies or other groups with~     economic interests. The project group itself has taken the initiative to study.~   "
96093|NCT01799330|"~     The two hypotheses to be tested in this study are that:~        1. The administration of transcutaneous electrical muscle stimulation (TCEMS) after~          completion of conventional exercise training in pulmonary rehabilitation (PR) will~          result in further improvements in exercise tolerance, functional status and symptoms of~          patients with stable chronic obstructive pulmonary disease (COPD) above those achieved~          in PR alone.~        2. TCEMS can improve exercise tolerance, functional status and symptoms even among COPD~          patients who fail to make gains in exercise tolerance by participating in conventional~          PR due to their debilitation and/or marked cardio-respiratory impairment.~   "
96184|NCT01798121|"~     A study to determine bioequivalence of PPD material versus Reference Standard.~   "
96094|NCT01799317|"~     The study outlined is designed to measure and to determine whether the combined use of~     vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or~     doxercalciferol alone will correct the mineralization defect in pediatric patients with~     established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis.~     Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder;~     (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone~     mineralization obtained at baseline and after 8 months of treatment will be measured by~     quantitative histomorphometry in iliac crest bone biopsies after double tetracycline~     labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest~     to examine the expression for selected markers of bone turnover and mineralization such as~     FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd~     generation immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be~     determined by one assay with specific detection antibodies that are against epitopes within~     the C-terminus of FGF-23 and another assay that uses antibodies against epitopes within the~     N- and C-terminal portions of the molecule respectively. The value of non-invasive~     assessment of bone mass by quantitative computed tomography (QCT) and its relationship with~     vascular disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be~     correlated with bone histomorphometry and the different biochemical determinations.~   "
96095|NCT01799304|"~     Cerebral palsy (CP) concerns 2 children out of 1000 in the general population (SCPE 2002).~     It is the main cause of postural and motor deficits in children.~      During the past 20 years, the postural deficits exhibited by these children have been~     attributed to various factors :~        1. neuromuscular functions~        2. sensory integration~        3. muscular-squeletic functions.~      The common point of all these studies is the existence of immature motor patterns, probably~     related to an inability to implement more elaborated and adapted motor patterns with respect~     the task to perform.~      CP children do not develop the characteristics of the plant grad locomotion. They exhibit a~     uniform muscular activation with a high level of co-activation. Locomotion is generally~     characterized by an increase of stretching reflexes at short latencies and by a low level of~     activation associated to a low modulation of gastrocnemius muscles..~      These data also suggest that it is the control of the temporal rather than the spatial~     parameters of the head which are mainly altered in CP children.~      Even though static postural control and locomotion are considered as automatic processes,~     this control requires, however, a significant amount of attentional resources.~      Within this context, the amount of attentional resources which need to be solicited can~     provide information on two complementary dimensions. On one hand, on the level of~     automaticity of postural control and/or locomotion when subjects' attention is oriented~     toward another task. On the other hand, on the cognitive cost of postural control and/or~     locomotion, depending on children age, that is, as a function of their level of maturation~     and of the nature and importance of their sensory-motor deficits. When the amount of~     required attentional resources is reduced, postural control and/or locomotion is considered~     as automatic processes with a low cognitive cost.~      The dual task paradigm in which subjects have to simultaneously process a cognitive (e.g.~     Stroop task) and a postural or motor task (e.g., standing upright on a force platform) is~     generally used to investigate these questions.~      How an appropriate allocation of attention is performed as a function of the cognitive and~     postural/motor tasks is important in the developmental process of posture and locomotion. It~     seems to be even more crucial in CP children and more generally in pathology.~      The main goal of the present project is to investigate the contribution of attentional~     processes in postural control and locomotion of CP children as compared to control healthy~     children.~   "
96096|NCT01799291|"~     The primary aim is to test the efficacy of a new intervention to improve clinical judgment.~     The investigators focus on the assessment of pediatric bipolar disorder (PBD), a~     controversial diagnosis with frequent diagnostic errors, by educating mental health~     professionals in common cognitive pitfalls and training them in recommended de-biasing~     strategies. The investigators hypothesize that the Treatment group will show higher~     diagnostic accuracy than the Control condition: Participants receiving the cognitive~     de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity~     bias. Secondary aims include soliciting feedback about whether the skills were useful when~     diagnosing the vignettes, and whether skills and cases seem clinically realistic.~   "
96097|NCT01799278|"~     This study will evaluate the response rate of MLN8237 in patients with histologically~     confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237~     is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor~     activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in~     dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine~     marker expression.~   "
96098|NCT01799265|"~     The purpose of this study is to determine whether the Transcend Auto is as effective in~     treating obstructive sleep apnea as another device that is already on the market.~   "
96099|NCT01799252|"~     The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear.~     The experiences of women prescribed routine antibiotics after medical abortion is missing~     from the existing evidence. This study seeks to add to the literature evidence of the side~     effects associated with antibiotic treatment that women experience and their adherence to~     prescribed regimens.~   "
96100|NCT01799239|"~     The aim of the current investigation is to evaluate the combination of an adhesive with a~     soft top film.~   "
96101|NCT01799226|"~     This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental~     gingivitis model developed by Löe et al. Half of the participants will use Colgate Total®~     (which contains triclosan), while the other half will use a toothpaste which does not~     contain triclosan as the control.~   "
96102|NCT01799213|"~     Knee osteoarthritis (OA) is now recognized as a major health problem. It is the number one~     cause of lower extremity disability and has significant deleterious effects on quality of~     life. While there are numerous therapies available for knee OA, most have limited efficacy.~     Of particular concern, is the widespread use of nonsteroidal anti-inflammatory drugs~     (NSAIDs) for this disorder. Veterans, as a group, are at high risk for both gastrointestinal~     and cardiovascular NSAID-induced complications. In this study the investigators propose to~     examine whether replacing NSAIDs with cognitive behavioral therapy delivered by telephone is~     an effective strategy for Veterans with knee OA. Telephone-administered therapy is~     particularly appealing since Veterans with knee OA are more likely to have limited mobility.~     If successful, this program may result in significant cost-savings for both Veterans~     (decreased co-pays and transportation costs) and the VA (decreased hospitalizations due to~     NSAID induced toxicity).~   "
96132|NCT01798823|"~     The goal of the project is to define the prevalence and inflammatory background of~     exercise-induced bronchoconstriction (EIB) in school children and determine individual and~     environmental risk factors for EIB. The obtained results will provide objective measures on~     biological processes leading to bronchoconstriction during exercise, as might be experienced~     naturally during the school life. The results could be applied in the management of EIB~     patients with or without asthma. The results of planned research will be published in~     journals with national and international impact, and presented during symposia and~     conferences.~   "
96103|NCT01799200|"~     The primary objective of this study is to investigate factors hypothesized to influence the~     prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults.~     To complete this objective, we will quantify the prevalence of radiographic measures~     indicative of hip pathomorphology in collegiate athletes and age-matched controls. This data~     will allow us to test our main hypothesis, that the prevalence of hip pathomorphology is~     higher in collegiate athletes than age-matched controls. To further elucidate the factors~     which may increase the prevalence of hip pathomorphology, we will correlate the radiographic~     measures to sport involvement history, hip function and demographics, as collected by means~     of a questionnaire.~      The secondary objective of this study is to determine if physical exams (range of motion,~     impingement test) could be used to screen for radiographic measures of hip pathomorphology~     in athletes and age-matched controls. To complete this objective, we will correlate range~     physical exam results to the radiographic measures and determine each exam's sensitivity and~     specificity to detect abnormal morphology.~   "
96104|NCT01799187|"~     Revascularization is an alternative new treatment of immature permanent teeth with necrotic~     pulp nowadays while apexification is the traditional therapy. The investigators suppose that~     revascularization is superior to apexification at developing the root of immature permanent~     teeth and reducing the risk of root fracture,and the research is designed.~   "
96105|NCT01799174|"~     This is a randomized, blinded, and controlled trial to assess the efficacy and safety of~     UVA1 phototherapy in the treatment of active morphea in adults and children. Forty patients~     will be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1~     phototherapy) with an ultraviolet translucent acrylic screen or sham UVA1 (0 J/cm2)~     phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The~     phototherapists, patients, and principal investigator will be blinded to whether the~     patients receive active or sham UVA1 phototherapy. Patients will only be allowed to apply~     emollients during the study.~      Patients completing the randomized placebo controlled trial (RPCT) will be followed during~     an open observation period for 3 months. During the open phase, all outcome measures from~     the RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients~     who received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy~     using the same protocol as in the RPCT during the open observation. Adult patients enrolled~     in the RPCT will also be part of a nested translational study investigating the effect of~     UVA1 phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1)~     and after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in~     lesional skin before and after treatment as well as nonlesional skin.~   "
96106|NCT01799161|"~     NSCLC tumors are appropriate targets for active immunotherapy, because they are~     non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune~     response.~      NSCLC tumor-secreted gp96-Ig is an ideal vaccine because it combines adjuvant activity with~     polyvalent peptide specificity. Tumor secreted gp96 activates dendritic cells (DC), natural~     killer cells (NK) and cytotoxic T lymphocytes (CTL). Tumor cells can be killed by~     NK-specific mechanisms, by promiscuous killing of CD8 CTL through NKG2D, and by MHC~     restricted CD8 CTL activity. The activation of DC and NK by tumor secreted gp96 may also~     counteract the generation of immuno-suppressive CD4 regulatory cells.~      Suppression of adenosinergic pathways by oxygen and theophylline in combination with~     immunotherapy will improve tumor rejection.~      Allogeneic, gp96-Ig secreting tumor cells used as vaccine are expected to generate NK and~     CTL with activity to the patient's autologous tumor.~   "
96107|NCT01799148|"~     The objectives of this study are: 1) To determine whether patients with acute coronary~     syndrome, the level of environmental exposure to particulate air pollutants in the week~     prior to admission, are related to concentrations of inflammatory molecules and oxidative~     stress. 2) To investigate whether the level of environmental exposure is an independent~     prognostic factor in terms of overall and cardiovascular mortality, myocardial infarction or~     unstable angina at 30 days, 6 and 12 months.~   "
96108|NCT01799135|"~     This is a pilot study. A pilot study is done with a small number of participants to see if a~     technique works before using it in a larger research study. This pilot study is evaluating a~     special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).~      DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how~     active the tumor is, as well as how functional the lungs are. As part of this scan,~     participants will receive an intravenous (into the blood via puncture of a vein) injection~     of gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly.~     Gadolinium is approved by the FDA and is routinely used for MRI.~      The goal of the study is to determine whether DCE-MRI can provide images of the response of~     the tumor and the normal lung tissue to SBRT and to potentially hep improve~     treatment-planning methods for patients treated with SBRT in the future. We will also study~     how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional~     computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we~     are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated~     with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology~     and is routinely used in the clinic for other indications. The 4D-CT scan is also not~     experimental and is used for radiation planning and imaging of the lungs.~      The SBRT you will receive will be standard treatment and will not be affected by your~     participation in this study or by these DCE-MRI scans. That means that the findings on the~     scan will not be used to alter your planned treatment in any way. Additionally, participants~     will undergo the routine work-up prior to SBRT and surveillance studies after treatment is~     complete.~   "
96109|NCT01799122|"~     Randomized comparison of two surgeries for the treatment of female stress urinary~     incontinence.~   "
96133|NCT01798810|"~     The OXYGEN Study is a double blinded prospective randomized controlled trial that will~     compare the proportion of surgical site infections within 6 months in patients treated with~     Supplemental Perioperative Oxygen compared to those treated without Supplemental~     Perioperative Oxygen.~   "
96134|NCT01798797|"~     A prospective post-market study to evaluate the performance and clinic usability of heart~     failure risk status (HFRS) feature on CareLink.~   "
96291|NCT01796730|"~     This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period~     followed by three treatment periods of 21-days each performed in patients with COPD.~     Patients will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg~     and placebo).~   "
96110|NCT01799109|"~     Asthma is a common chronic respiratory illness which results in frequent wheezing,~     cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy,~     β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although~     inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma~     exacerbation, there are still some asthmatic children unresponsive to this management. The~     Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate~     (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous~     MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g~     relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized~     SAB provides greater benefit in severe asthma exacerbation.~   "
96111|NCT01799096|"~     This study partially replicates two previous studies with normal weight women, and~     overweight women. Both found that women could compensate for sucrose added to the diet in~     carbonated soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period~     of 4 weeks. The hypothesis is that this applies also to obese women, who will not gain~     weight, increase overall energy intake in the diet, or eat differently whilst consuming~     sucrose. 42 participants shall be randomly assigned to either be given carbonated drinks~     that contain sucrose, or drinks that are artificially sweetened.~   "
96112|NCT01799083|"~     Determine alone or in combination with chemotherapy or autologous cytokine induced killer~     cells are effective and safe in the treatment of patients with relapsed and/or refractory~     solid tumors or B Cell lymphomas.~   "
96113|NCT01799070|"~     Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of~     carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to~     predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP~     post-operatively comparing with baseline BP should be a predictive factor of CHS.~      Objective: The investigators aimed to create a predictive index, velocity systolic blood~     pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring~     regarding CHS.~      Methods: The study design is a diagnostic test, which is an observational analytic clinical~     study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be~     classified according to the CHS occurrence. VSI combined the changes of middle cerebral~     artery velocity and blood pressure crossing CEA and the intra- and post-operative increase~     ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS~     will be compared. Sensitivity, specificity, positive predictive value, negative predictive~     value of them will be calculated. Receiver operating characteristic analysis will be~     performed.~      Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD~     monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as~     the investigators know, analysis or studies combining the BP and velocity changes in the~     prediction of CHS have never been performed.~   "
96114|NCT01799057|"~     The purpose of this study is to determine the effects of metformin on functional capacity~     (pain-free and maximum walking times) in individuals with peripheral artery disease~     (PAD)-related intermittent claudication.~   "
96115|NCT01799044|"~     Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat~     tumors near or around vulnerable structures, such as central liver tumors.~      To investigate the safety and efficacy of IRE in the treatment of colorectal liver~     metastases, patients with resectable colorectal liver metastases undergo IRE and resection~     of the metastases in the same session. After resection, the specimen is examined~     macroscopically to determine vitality using a specific vitality staining~     (triphenyl-tetrazoliumchloride) and to visualize the exact ablation zone. Subsequently,~     histopathologic examination is used to determine type of cell death and the microscopic~     ablation zone.~      The investigators hypothesize that IRE is a safe effective method to treat colorectal liver~     metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the~     procedure.~   "
96116|NCT01799031|"~     This randomized clinical trial studies an educational intervention for reducing work~     disability in breast cancer survivors. Web sites providing symptom management education may~     be an effective method to help breast cancer survivors reduce work disability after~     treatment~   "
96117|NCT01799018|"~     The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral~     Vasospasm following Subarachnoid Hemorrhage~   "
96118|NCT01799005|"~     Atherosclerosis progressively occurs with increasing age in the general population. So far~     most dietary intervention studies with flavanols were performed over short time frames and~     in small groups of young healthy and older patients with manifest cardiovascular disease,~     respectively. Vascular health is defined as absence of vascular disease and the presence of~     optimal parameters that determine the development and progression of arteriosclerosis~     (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether~     flavanols can improve parameters of vascular health, most importantly endothelial function,~     when given repetitively to healthy middle aged and which factors affect the efficacy of~     flavanol interventions.~   "
96127|NCT01798888|"~     Background:~      - Current treatments for alcoholism have limited success. More than half of people with~     alcoholism return to uncontrolled drinking even after treatment or self-help programs. One~     possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral~     capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small~     group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s~     disease, but not for treating alcoholism. Researchers want to study whether DBS can be used~     to treat chronic alcoholism.~      Objectives:~      - To see if deep brain stimulation is helpful and safe for people who have chronic~     alcoholism.~      Eligibility:~        -  Individuals between 21 and 60 years of age who have been diagnosed with chronic~          alcoholism.~        -  Participants must have tried for more than 10 years to stop drinking alcohol, and have~          failed multiple treatment and self-help programs. They may not have any other current~          substance abuse or dependence problem (except alcohol and nicotine).~      Design:~        -  Participants will start the study by entering a separate alcohol detoxification study~          at the National Institutes of Health. They will be monitored during this study with~          blood tests and brain scans.~        -  Participants will have 2 weeks of baseline tests. They will include physical exams and~          blood and urine tests. They will also include tests of thinking and memory, and~          questions about current moods.~        -  Participants will have surgery to insert the DBS device. Electrodes will be placed in~          the brain and a battery pack will be placed in the chest. Participants will recover~          from the surgery and continue the alcohol detoxification program.~        -  About 4 weeks after surgery, participants will be separated into two groups. For one~          group, the DBS device will be turned on with electrical stimulation and participants~          will be monitored for an additional two weeks in the hospital to find the right setting~          for the device. For the second group, participants will receive mock stimulation, but~          no real electrical DBS, and will also be monitored for an additional two weeks in the~          hospital.~        -  Participants will return home for 24 weeks. During this time they will have frequent~          study visits to look at the DBS device. These visits will include questions about mood~          and memory, as well as imaging studies.~        -  All participants will return for an additional two week inpatient stay in the hospital.~          Those participant who had initially received mock stimulation will now have their~          devices turned on with real electrical stimulation and will be monitored for the two~          weeks to find the right setting for the device. Those participants who had initially~          received real stimulation will continue to receive stimulation while being monitored~          for the two weeks.~        -  Participants will return home for another 24. All participants at this point will have~          actual electrical DBS. Participants will continue to have frequent study visits for up~          to a year to look at the DBS device. These visits will also include questions about~          mood levels and alcohol cravings.~   "
96119|NCT01798992|"~     The primary goal of the study is to measure in the intact human heart, the alterations in~     gene expression over time that are associated with reverse remodeling in response to~     β-blockade. The second goal is to investigate the signaling mechanisms which in turn are~     responsible for these changes in gene expression, and the third goal is to determine the~     relationship between intrinsic systolic dysfunction and remodeling of the left ventricle.~     This will be accomplished by measuring ventricular size, function, and gene expression in~     myocardial tissue samples obtained by percutaneous biopsy prior to initiation of β-blockade~     and at 3 and 12 months after start of therapy. The specific Aims and Hypotheses to be tested~     are:~        1. Aim: Determine the changes in gene expression associated with changes in intrinsic~          systolic function and with functional decompensation in the intact, failing human~          heart.~           a. Hypothesis: Changes in the expression of select genes precede or accompany changes~          in left ventricular systolic function in humans with idiopathic dilated cardiomyopathy~          (IDC).~        2. Aim: Identify signaling mechanisms responsible for alterations in expression of key~          genes involved in mediation of ventricular hypertrophy or contractile dysfunction.~           a. Hypothesis: Myocardial-failure-associated regulation of select messenger ribonucleic~          acids and proteins are related to left ventricular wall stress and neurohormonal~          signaling.~        3. Aim: In the relationship between contractile dysfunction and dilatation/remodeling,~          determine the relationship between contractile dysfunction and structural remodeling.~           b. Hypothesis: the contractile dysfunction is primary and structural remodeling~          secondary.~   "
96120|NCT01798979|"~     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of~     GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted~     normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2~     occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of~     GLPG0634 (daily for 7 days).~      Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with~     midazolam in healthy male subjects will be evaluated.~   "
96121|NCT01798966|"~     Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher~     orbital fat contents due to their disease process. The confined space of the orbit cannot~     hold the enlarged orbital contents creating a forward displacement and/or compression of the~     globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical~     decompression, a procedure that fractures orbital bones, in order to allow more space for~     the enlarged orbital contents to occupy. To date, there is no data that shows intraocular~     patterns over a 24-hour period in patients with mechanical compression on the globe as in~     TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns,~     glaucomatous patterns, or perhaps completely different then either. The goal of this project~     is to investigate patterns of IOP in patients requiring orbital decompression because of~     orbital congestion. Changes in IOP during a 24-hour period will be studied with a~     contact-lens embedded sensor that provides continuous data. This device has previously been~     investigated and shown to be safe and well-tolerated. Monitoring the pattern in these~     patients will allow us to compare Thyroid TED patterns of IOP with those of normal and~     glaucomatous patients. Also, testing these patients before and after orbital decompression~     surgery will allow characterization of how intraocular pressure changes once the mechanical~     compression on the globe is relieved.~   "
96122|NCT01798953|"~     Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with~     ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose~     of this study was to determine the functional outcome after surgery, frequency of pouchitis,~     complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both~     ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.~   "
96123|NCT01798940|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc.~     Dosing periods of studies were separated by a washout period of 12 days and 11 days~     respectively.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
96124|NCT01798927|"~     The purpose of this study is to investigate the impact of a specifically designed ankle foot~     orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and~     temporal gait parameters, electromyography (EMG) and walking endurance, in select~     individuals living with Parkinson's disease.~   "
96125|NCT01798914|"~     The purpose of this study is to allow patients with specific needs for inhaled insulin to~     continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn~     from the market.~   "
96126|NCT01798901|"~     This phase I trial studies the side effects and best dose of AR-42 when given together with~     decitabine in treating patients with acute myeloid leukemia. AR-42 may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving AR-42 together with~     decitabine may kill more cancer cells.~   "
96128|NCT01798875|"~     In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS)~     is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn~     lead to the development of diabetes, hypertension, atherosclerosis and coronary heart~     disease. Serum markers of inflammation are being increasingly recognized as predictors of~     atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been~     recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2~     diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of~     commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral~     contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate~     cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the~     commonly used therapies of women with PCOS may have more favorable effects on classical and~     surrogate markers of cardiovascular risk then others or some of them may even confer a~     higher risk of cardiovascular events~   "
96129|NCT01798862|"~     The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle~     sampling in the preceding non- transfer cycle improves the IVF outcome parameters in~     patients with previous IVF failures.~   "
96135|NCT01798784|"~     In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients~     with suboptimal cholesterol control who are at high risk for CVD, the study investigators~     propose to test the effectiveness of different behavioral economic techniques in inducing~     habit formation for adherence to statin use and sustained reductions in LDL cholesterol~     after financial incentives are discontinued. Primary outcome is changes in LDL from~     enrollment to 12 months (6 months after cessation of financial incentives).~   "
96136|NCT01798771|"~     The investigators hypothesize that the rate of radiologically complete resections of~     contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced~     fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to~     surgeries aided by 5-ALA induced fluorescene alone.~   "
96137|NCT01798745|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in~     participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The~     safety and tolerability of JNJ-54452840 will also be assessed.~   "
96138|NCT01798732|"~     The main objective of this study is to characterize the changes in IOP over 24 hours after~     selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP,~     type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes~     in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic~     nerve head after selective laser trabeculoplasty.~   "
96139|NCT01798719|"~     Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated~     with the metabolic syndrome. As the disease stems from excess calorie intake and lack of~     physical activity, the correction of unhealthy lifestyles is the background of any~     prevention and treatment strategy~   "
96140|NCT01798706|"~     Primary objective:~      - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on~     glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2~     diabetes participants (T2DM) who are inadequately controlled with their current~     anti-diabetic treatment regimen.~      Main secondary objective:~      - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM~     participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic~     hypoglycemia and gastrointestinal side effects).~      Other secondary objectives:~        -  To assess the effect of lixisenatide compared to placebo after 24-week treatment on:~             -  Fasting plasma glucose (FPG);~             -  During liquid standardized breakfast meal challenge test : 2 hour- Postprandial~               Plasma Glucose (PPG) and Plasma Glucose Excursion;~             -  7-point Self-monitored plasma glucose (SMPG) profile;~             -  Body weight;~             -  Change in total daily dose of basal insulin (if taken);~             -  Percentage of participants requiring rescue therapy~             -  Safety and tolerability;~        -  To assess lixisenatide pharmacokinetic profile;~        -  To assess anti-lixisenatide antibody development.~   "
96141|NCT01798693|"~     Rotator Injury:~        -  Strength/range of Motion~        -  ASES, VAS~   "
96142|NCT01798680|"~     The purpose of this study is to determine the efficacy and safety of vitamin D3~     (cholecalciferol) supplementation on HIV progression and incidence of pulmonary tuberculosis~     among HIV-positive Tanzanian adult men and women initiating highly active antiretroviral~     therapy (HAART).~   "
96143|NCT01798667|"~     This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the~     optimal dose of DA-8031 in male patients with premature ejaculation after oral~     administration on-demand.~      The investigators hypothesized that newly-developed DA-8031 would effect in delaying~     ejaculation in patients with premature ejaculation (PE).~      Design:~      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose~     design~   "
96144|NCT01798654|"~     The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle~     aspiration (EUS-FNA) for patients with antithrombotic agents.~   "
96145|NCT01798641|"~     The goal of our study is to verify the effectiveness of the shunt and to identify the most~     sensitive criteria to select patients for surgery. The study is designed to assess~     improvement in walking and balance (gait), urinary function and memory after shunting. In~     addition, the study aims to identify the most accurate and sensitive tools to measure~     improvement for our patients.~   "
96146|NCT01798628|"~     The purpose of this study is to determine the effect of food on the pharmacokinetics (how~     the drug concentrations change over time) of abiraterone acetate 1000 mg when administered~     as a single dose in healthy male volunteers.~   "
96147|NCT01798602|"~     The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with~     suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and~     study procedures.~   "
96148|NCT01798589|"~     The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when~     prepared using methylcellulose versus preparation using polyvinylpyrrolidone.~   "
96149|NCT01798576|"~     This prospective, national, multicenter, observational study will evaluate in routine~     clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon~     alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with~     chronic hepatitis C who failed previous treatment. Participants will be followed for the~     duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.~   "
96150|NCT01798563|"~     In this study the investigators are looking at two subtypes of Parkinson Disease (PD);~     tremor-dominant (TD) and postural imbalance and gait disorder (PIGD). This study will use~     magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a~     finger-tapping task while on and off PD medication. This study will look at the differences~     between the two sub-types of PD and healthy volunteers.~      The investigators will test the hypothesis that connectivity at rest within the motor cortex~     and between the motor cortex and motor-associated regions such as the supplementary motor~     area and the pre motor cortex will not be as strong in PIGD compared to TD (increased~     activity and functional connectivity in TD group)~   "
96163|NCT01798394|"~     The primary goal of this project is to investigate the potential efficacy of exogenous~     progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new~     mothers. Also to determine the feasibility of enhanced compliance monitoring and~     identification of collateral factors effecting outcomes.~   "
96151|NCT01798550|"~     The purpose of this study is to determine an effective enoxaparin dosing strategy in~     medically ill, morbidly obese patients. This study will include adult patients greater than~     18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable~     patients such as prisoners, children, and pregnant women will not be enrolled in the study.~     Study participants will be contacted in person by the study personnel once inclusion~     criteria are met. Written informed consent will be obtained in person while hospitalized.~     Once the patient is consented they will be given enoxaparin and blood samples will be drawn.~     The data collected will be from the electronic medical record which is accessed only with a~     username and password so it is not publicly available. The data will be identifiable upon~     collection and will be kept on a password protected file on a computer in a locked office.~     The data will be de-identified after data analysis and only the study personnel will have~     access to the code that links identifiers to subjects. A HIPAA waiver will be requested to~     access existing data in order to identify patients for enrollment. All data will be~     collected in an office in the hospital. The study participants' burden will be minimal and~     dependent only on time of consent process since morbidly obese patients would be receiving~     this blood sample collection regardless of their participation in the study.~   "
96152|NCT01798537|"~     A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening~     and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of~     blood stream infections and to a 25% reduction in lower airway colonization with multi drug~     resistant organisms. There will be no concomitant rise in gram-positive or fungal infection~     or a surgency of new resistance patterns.~   "
96153|NCT01798524|"~     Kidney transplantation is the renal replacement therapy of choice for the majority of~     patients with end-stage kidney disease. Epidemiological studies of kidney allograft~     recipients can aid in the understanding of cause and effect of health and disease~     post-transplantation. The combination of health care and information technology has made the~     potential of transplant professionals to use health information effectively crucial to guide~     kidney transplant management. The aim of this study is to undertake an observational cohort~     study of kidney allograft recipients, supported by linking analysis across different~     database sources, to provide a comprehensive biomedical dataset of information.~   "
96154|NCT01798511|"~     Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of~     surgeons and gastroenterologists throughout the world. The high rate of pain relapse after~     oral refeeding contributes to high consumption of healthcare resources and prolonged~     hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early~     administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in~     AP. The potential beneficial effects of enteral tube feeding include induction of~     postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This~     may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing~     cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral~     food intolerance. All eligible AP patients will be randomly allocated to either the Early~     Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of~     hospital admission.~   "
96155|NCT01798498|"~     The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME~     for the correction of nasolabial folds.~   "
96156|NCT01798485|"~     The purpose of this study is to determine whether combining ganetespib (STA-9090) with~     docetaxel is more effective than docetaxel alone in the treatment of patients with advanced~     non-small cell lung cancer.~   "
96157|NCT01798472|"~     The aim of this study is to compare the functional and radiological outcome after displaced,~     femoral neck fractures treated with either cemented or uncemented arthroplasties.~      The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome~     at 12 month as the cemented arthroplasty.~   "
96158|NCT01798459|"~     The purpose of the study is to explore the effect of methylphenidate on state anxiety in~     children with attention deficit hyperactivity disorder.~      Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The~     subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years~     of age.~      Structure: the study is a randomized double blind crossover study. The subjects will~     complete a continuous performance test, the cambridge neuropsychological test automated~     Battery, before and after given methylphenidate or placebo on the first day of the study. On~     the second day of the study, the subjects will receive either methylphenidate or placebo~     based on what was given on the first day of the study and they will complete the same task.~   "
96159|NCT01798446|"~     -  1. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC).~        -  2. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF~          treatment.~        -  3. There is no trial of axitinib for non-clear cell RCC.~        -  4. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in~          renal cell carcinoma.~   "
96160|NCT01798433|"~     In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective~     2-stent strategy is superior to provisional strategy at preventing the occurrence of~     12-month target lesion failure after percutaneous coronary intervention for bifurcation~     lesion.~      In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique~     with mandatory final kissing ballooning is superior to 1-stent technique without kissing~     ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous~     coronary intervention for bifurcation lesion.~   "
96161|NCT01798420|"~     Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to~     significantly increase hemoglobin A1C levels~   "
96162|NCT01798407|"~     This research study will investigate the safety, tolerability, and benefit of bilateral deep~     brain stimulation (DBS) to the lateral habenula for patients with treatment-resistant major~     depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD),~     or bipolar disorder (BD) I. Six adult patients with TRD will be treated in this single-site~     study at Baylor College of Medicine; patients will be chronically symptomatic with~     significant functional disability, and will have demonstrated resistance to standard somatic~     and pharmacotherapeutic treatments. The primary outcome measure will be the change in the~     17-item Hamilton Depression Rating Scale (HDRS17) six months after the commencement of~     stimulation.~   "
96166|NCT01798355|"~     The purpose of this study is to determine whether cognitive behaviour therapy is effective~     in the treatment of children and adolescents with dental anxiety. Our hypothesis is that~     children and adolescents who have been offered CBT shows significant better performance on~     outcome measures compared with patients in control group who have received treatment as~     usual.~   "
96167|NCT01798342|"~     Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to~     decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance~     the benefits of CHO alone. However, only a few studies tested the safety of this formula.~     The objective of this study was to evaluate the gastric residual volume (GRV) after the~     intake of a beverage containing CHO plus GLN using magnetic resonance (MRI).~   "
96168|NCT01798329|"~     The aim of the study is:~        -  Epidemiological/observational: investigating the presence of neuropsychological and~          electrophysiological alterations, suggesting a condition of minimal hepatic~          encephalopathy(and its behavioral correlates), in childhood and young adulthood~          affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for~          implementing specific diagnostic protocols.~        -  Interventional: collecting preliminary data on the effects of a probiotic, in order to~          implement a controlled clinical study.~   "
96169|NCT01798316|"~     The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain~     management after laparoscopic cholecystectomy, to determine if its use decreases the~     incidence of post-operative nausea and vomiting without compromising pain control.~   "
96170|NCT01798303|"~     The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose~     of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce~     alcohol drinking in these participants. The study will last for 8 weeks.~   "
96171|NCT01798290|"~     Objective: The aim of this study is to assess the impact of an educational program of~     Narrative Medicine workshop reading diaries dedicated to medical students on their~     empathy.~      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of~     the University Paris Descartes. Methods: participants will be randomized in 2 groups. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician. Participants will be blinded of the study~     hypothesis. Allocation concealment will be provided because only the statistician will have~     access to the randomization list.~      A program of Narrative Medicine with lesson in small group of workshop reading patients'~     diaries  vs workshop reading literature.~      Outcome: The primary endpoint will be a first measure of the empathy of the medical~     students. The secondary endpoints will be a second measure of the empathy of the medical~     student; satisfaction of the student relative to the educational program .~      Potential interests: We believe that the workshop reading patients' diaries can develop~     the thinking of the student with respect to his behavior with the patient, and so the~     relation between student and patient.~      Sample size expected: 200 participants.~   "
96172|NCT01798277|"~     This study aims to compare antiarrhythmic drug therapy with catheter ablation using the~     SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular~     tachycardia and coronary artery disease~   "
96173|NCT01798264|"~     evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.~   "
96174|NCT01798251|"~     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of~     elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.~   "
96175|NCT01798238|"~     The study design of this trial is double blind, parallel-group, randomized, placebo~     controlled study~   "
96176|NCT01798225|"~     Our overall hypothesis is that treatment of periodontal disease will produce better diabetes~     glycemic control (glycated hemoglobin A1c, or HbA1c) and reduced levels of the catalytically~     active form of matrix metalloproteinase (aMMP-8) in the Gullah African American type 2~     diabetes patients living on the Sea Islands of the South Carolina coast. The gingival~     crevicular fluid (GCF) aMMP-8 levels will be measured through a site-specific, novel~     noninvasive technique allowing the pathophysiological status of the periodontium tissue to~     be monitored. The investigators will conduct an interventional study on this population with~     minimal genetic admixture.~   "
96177|NCT01798212|"~     A prospective multi center case controlled trial on the clinical feasibility of a new full~     thickness endoscopic plication device for patients with GERD.~      The primary objective of the present trial is to investigate, clinical feasibility of the~     GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary~     objective of the trail is to evaluate objective data before and after the procedure, using~     manometry and 24h impedeance measurement~   "
96178|NCT01798199|"~     Virtual environments and information communication technologies (ICT) offer large~     perspectives in the field of assistive care and rehabilitation.~      As potentially endless, the scenarios and environment used using 3D can provide immersive~     social and interactive context for enjoyable and therapeutic exercises in the aging~     population. In addition it is also possible to use this type of serious game and scenario in~     very easy to use devices such as lap top or tablet.~      Social exclusion has many causes, Apathy as one of the most common behavioural disturbances~     found in old adults populations alters significantly social and emotional interaction.~      Even though, progress in VR has been made over the past year, the presence of such~     technology in daily living space is still at the embryonic stage.~      The European e-Inclusion policy stresses the importance of ICT in improving the quality of~     life in potentially disadvantaged groups, including older people and persons.~      The VERVE project is developing ICT tools to support the treatment of people who are at risk~     of social exclusion due to apathy associated with a disability.~      As people aged and autonomy worsen fear for safety and comfortable means to maintain social~     and Health Related Quality of Life (HRQL) status are public health issues.~      Moreover, even though older adults would like to perform some activities such as walking in~     the streets some are reluctant to go out of their homes as the external environment is~     perceived as potentially unsafe.~      Apathy, the most common behavioural symptoms in aging population is characterized by~     symptoms of reduced initiation and responsiveness to environmental interactions. The~     syndrome of Apathy takes form of diminished goal-directed behaviour, characterised by~     emotional blunting, loss of initiative and loss of interest. Apathy along with the~     nosological characteristics of dementia induces impairment in autonomy level and therefore~     dependence as cognitive impairments worsened.~      The importance of stimulation could be related to the concept of engagement defined as the~     act of being occupied or involved with an external stimulus. Engaging older person with or~     without Alzheimer's disease and related disorders in appropriate activities has been shown~     to yield beneficial HRQL effects such increasing positive emotion, improving cognition,~     functional autonomy and quality of life.~      Accordingly, enriched environments with high definition virtual representation of cities and~     activities of interest have the potentials not only to encourage patients to get active in a~     safe and interactive environment but also to create access to enjoyable and stimulating~     settings for the more severe patients.~      The VR setting from VERVE proposed personalised and populated environments available on two~     different, but interlinked hardware platforms: 1/: standard gaming set-up in the home,~     nursing home or day hospital therapy group; and 2/ mobile tracked internet devices~     (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web~     technologies.~   "
96179|NCT01798186|"~     This primary aim of this study is to assess the effects of active versus passive~     (second-hand) inhalation of cannabis smoke on toxicological analysis of native oral fluid~     (saliva) and blood specimens. The results of this study will help inform the validity of~     oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long,~     passive inhalation of cannabis smoke could result in a positive toxicology result.~   "
96180|NCT01798173|"~     Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well~     understood in absence of studies taking into account all recognised factors. A large scale~     clinical, biochemical and molecular studies is potentially relevant to the understanding of~     nutrition, physical activity, body weight metabolic syndrome whatever the etiology of~     underlying cirrhosis. It will open new perspectives :~        -  in prevention of hepatocellular carcinoma development in cirrhotic patients through~          dietary counselling and therapeutics of metabolic syndrome,~        -  in early screening of hepatocellular carcinoma in cirrhotic patients through~          spectroscopic technology and later proteomic study resulting in an improvement of~          hepatocellular carcinoma prognosis.~   "
96181|NCT01798160|"~     Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the~     treatment of intermediate stage hepatocellular carcinoma.~   "
96182|NCT01798147|"~     Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the~     treatment of intrahepatic cholangiocellular carcinoma (CCC).~   "
96183|NCT01798134|"~     This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead~     transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™~     Microspheres to treat hepatocellular carcinoma (HCC).~   "
96185|NCT01798108|"~     A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as~     Alpharadin), is currently under development. It is an injectable aqueous solution~     containing radium-223, a radionuclide that emits radiation of another quality and with a~     different distribution than radiopharmaceuticals currently in use.~      After injection of the drug into the blood, a large portion of the drug will accumulate in~     the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer~     in the painful sites of bone than in other sites of the body, and may alleviate pain through~     its radiation. Radium-223 is expected to be both efficacious as regards the targeted~     localised irradiation, and also to have a favourable safety profile.~      The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first~     clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of~     various radioactivity doses of Radium-223 will be evaluated.~   "
96186|NCT01798095|"~     Determine if investigational products and reference standard produce similar responses.~   "
96187|NCT01798082|"~     Pelvic organ prolapse is a common condition that affects millions of women every year. There~     are many options for treatment and it can be difficult to make a decision as how best to~     proceed. Previous studies have shown that decisional aids (DAs) may improve knowledge,~     physician-patient communication, decisional conflict, and patient satisfaction. However, no~     study has evaluated the role of a decisional aid among women presenting for evaluation and~     management of prolapse. We would like to determine if a decision aid for prolapse decreases~     the amount of decisional conflict women face when choosing a plan of care.~      We hypothesize that there will be a difference in the level/amount of decisional conflict~     between women who receive a DA and those who do not. Specifically, we anticipate that women~     randomized to receiving standard counseling and a DA with have less decisional conflict than~     the cohort receiving standard counseling alone.~   "
96188|NCT01798069|"~     Objective: The aim of this study is to assess the impact of an educational program of~     Narrative Medicine workshop reflexive writing dedicated to medical students on the~     satisfaction of standardized patients.~      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of~     the University Paris Descartes. Methods: Participants will be randomized in two groups. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician. Participants will be blinded of the study~     hypothesis. Allocation concealment will be provided because only the statistician will have~     access to the randomization list.~      A program of Narrative Medicine in Class-led instruction workshop reflexive writing vs~     workshop reading medical publication.~      Outcome: The primary endpoint will be the satisfaction of standardized patient relative to~     the empathy of the medical students. The secondary endpoints will be the empathy of the~     medical students; recommendation of the student by the standardized patients to friends or~     relatives; students' satisfaction.~      Potential interests: The investigators believe that the workshop reflexive writing can~     develop the thinking of the student with respect to his behavior with the patient, and so~     the relation between student and patient.~   "
96189|NCT01798056|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in adults with solid tumours undergoing chemotherapy.~   "
96190|NCT01798043|"~     The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in~     cardiac function after 12 months of pacing in patients with pacing leads placed in different~     positions within the right ventricle (apically or septally).~   "
96191|NCT01798030|"~     Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes,~     hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed~     to sunlight and it is also obtained from the diet and dietary supplements. Older people,~     individuals with high skin pigmentation, obese and sedentary individuals have low levels of~     Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical~     inactivity are associated with reduced exposure to sunlight, and obesity is associated with~     the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues~     that require its metabolic action. These conditions are also associated with heightened risk~     for developing type 2 diabetes, glucose intolerance, hypertension, and~     osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in~     older women who tend to have increased body fat, are more physically inactive and are at~     high risk for central obesity and its metabolic consequences of diabetes, hypertension and~     osteoporosis.~   "
96192|NCT01798017|"~     This open-label study is being conducted to determine whether a mifepristone-misoprostol~     regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later~     by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for~     introduction in public sector facilities in Bangladesh. It will also determine the~     feasibility of women availing the option of taking their dose of misoprostol outside the~     facility.~   "
96193|NCT01798004|"~     This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after~     chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come~     back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops~     the growth of tumor cells by stopping them from dividing or killing them. After treatment,~     stem cells are collected from the patient's blood and stored. More chemotherapy or radiation~     therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are~     then returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy.~   "
96194|NCT01797991|"~     This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double~     blind pilot study.~      The purpose of this pilot study is to assess the feasibility of a trial designed to compare~     the quality of life of patients taking dexamethasone in two different ways to prevent~     hypersensitivity reactions to paclitaxel.~      Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of~     life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce~     adverse effects compared to dexamethasone given orally 12 hours and 6 hours before~     paclitaxel.~   "
96195|NCT01797978|"~     This study is to see whether the intravenous administration of methylene blue improves the~     outcome in severe sepsis and septic shock.~   "
96196|NCT01797965|"~     The primary objective of the study is to assess the safety and tolerability of long-term~     treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants~     with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301~     (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).~      Secondary objectives of this study in this study population are as follows:~      To describe MS-related outcomes, including MS relapse, disability progression, MS lesion~     formation, and participant-reported impact of MS, following long-term treatment with DAC HYP~     To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To~     assess the safety, tolerability, and efficacy of switching to DAC HYP in participants~     previously on long-term treatment with interferon β-1a (Avonex) in Study~     205MS301(NCT01064401).~   "
96197|NCT01797952|"~     The study will be conducted at departments of Medical Oncology and Hematology, All India~     Institute of Medical Sciences (AIIMS).~      Patients with various malignancies who are taken up for high dose chemotherapy followed by~     stem cells transplant (blood and marrow transplant) have very high chances of developing~     severe oral mucositis (generally 60-80% in different studies and our own previous~     experiences). This not only causes significant morbidity but also hampers quality of life~     needing use of parenteral nutrition, analgesics, and antibiotics.~      No definite treatment exists for prevention or treatment of oral mucositis in this group of~     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth~     factor) will reduce duration and severity. Palifermin is very expensive and not available in~     country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2~     in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck~     squamous cell cancer patients. (Published online in European Journal of Cancer:~     http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No~     significant toxicity has been reported with its use.~      A pilot study on similar aspect was completed recently at our center(Clinical trial.gov~     identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade~     III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce~     severity of mucositis in patients undergoing myeloablative hematopoietic stem cell~     transplantation. The study drug and placebo will be supplied by CD Pharma India Private~     Limited.~      Investigators further give undertaking that study will be carried as per GCP and declaration~     of Helsinki.~   "
96198|NCT01797939|"~     Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease~     (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that~     depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses~     to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still~     remain controversial. Therefore, the aims of this study were to investigate the efficacy of~     PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic~     GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS),~     Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and~     depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).~   "
96199|NCT01797926|"~     This is a three-period, three sequence, reference replicated, cross-over study to determine~     the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and~     FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine~     and losartan tablets co-administered in two groups enrolling 102 healthy adult male and~     female subjects under fasting conditions.~      A description of each treatment is provided below:~      A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x~     5 mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x~     100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The~     treatments will be administered in accordance with the randomisation schedule as.~      Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C~     All subjects will attend a screening visit within 28 days of their first dosing period (Day~     1). The baseline assessments will be conducted the day before the first dosing.~      In each treatment period, subjects will be admitted to the clinic in the evening before Day~     1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on~     Day 1. All the subjects will remain in the clinical unit until completion of all assessments~     at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample.~     Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours~     post-dose.~      The three treatment periods will be separated by a washout period of 10-17 days. Upon~     completion of the last dosing period, or early withdrawal, subjects will return to the~     clinical unit within 14-21 days for a follow up visit.~   "
96200|NCT01797913|"~     assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced~     non-small cell lung cancer~   "
96201|NCT01797900|"~     The purpose of this study is to determine whether Intensity-modulated radiation therapy~     (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin~     and paclitaxel) is feasible and effective than current standard treatment for high-risk~     locally advanced NPC patients.~   "
96202|NCT01797887|"~     Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle~     counseling compared to conventional standard diet and lifestyle counseling in outpatient~     mothers with burnout-syndrome.~   "
96203|NCT01797874|"~     To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.~   "
96215|NCT01797718|"~     Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based~     effective and safe treatment option. This study compares the effects of low-dose~     testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is~     that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo)~     induces faster biochemical and clinical progression of puberty as compared to low-dose~     intramuscular testosterone Rx (~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select~     watchful waiting instead of medication will provide background data on the natural~     progression of CDGP, and their data will not be used in primary statistical comparisons.~   "
96216|NCT01797705|"~     The purpose of this protocol is to improve the current FDA-approved continuous positive~     pressure auto-titration algorithm, including treatment precision, residual disease detection~     characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.~   "
96204|NCT01797861|"~     Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that~     often occurs in patients in the professionally active age range. In this disease, there is~     pooling of fluid under the central retina (the macula). This specific form of macular~     degeneration can cause permanent vision loss, image distortion, loss of color and contrast~     vision due to this fluid under the retina. An early diagnosis and treatment may improve the~     visual outcome and quality of life. To date there is no international consensus on the~     optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with~     photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may~     also be effective in this disease.~      The proposed study is the first prospective randomized controlled trial in chronic CSC. In~     this study, participants with chronic CSC will be randomized into two treatment groups, PDT~     or ML treatment. The trial is a superiority study, because retrospective studies suggest~     that PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is~     challenged against ML treatment.~      The null hypothesis of the study is that PDT treatment is more effective than ML treatment~     in patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not~     more effective than ML treatment in these patients.~      Treatment success will not only be based on anatomical improvement, but also on functional~     endpoints, which are most important from a patient's perspective.~      The study will take place in five large tertiary referral university hospitals in Europe~     that have extensive experience with conducting clinical trials (in Nijmegen, the~     Netherlands; Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris,~     France). Each of these centers has confirmed sufficient funding to conduct the research. The~     study will last max. 8 months per participant. Each participant will come for 5 (in the case~     of 1 treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly~     part of regular clinical care. The whole study will last for max. 24 months.~   "
96205|NCT01797848|"~     The purpose of this study is to determine whether 24 week treatment with the Daclatasvir~     (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is~     safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24)~     (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48~     weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects~   "
96206|NCT01797835|"~     Screening youth in the primary care setting is one way to identify adolescents who may be~     at-risk for future alcohol problems. The current study tests the new NIAAA screening guide~     questions, which ask about friend and adolescent drinking, to see how well these questions~     work to predict subsequent alcohol use, problems, and involvement in other risk behaviors,~     such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a~     brief motivational intervention for some at-risk teens and see whether alcohol use differs~     for those teens who receive the intervention and those teens who receive enhanced usual~     care. The results of this study have the potential to significantly impact the standard of~     care for identifying and intervening with at- risk youth in primary care settings.~   "
96207|NCT01797822|"~     The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the~     counter artificial tears and the prescription eye drop, dexamethasone, change or effect the~     eyes response to a low humidity environment.~      It is known that irritation from dry eye can be improved by over the counter artificial~     tears because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can~     also improve eye irritation by decreasing the inflammation that develops in dry eye. Thus,~     the investigators hypothesize that the use of these conventional dry eye treatments will~     improve the eyes' response to a low humidity environment.~   "
96208|NCT01797809|"~     The objective of this PMS is to gain information about safety and efficacy in real practice~     as a regulatory commitment required by KFDA(Korea Food and drug administration)~   "
96209|NCT01797796|"~     The purpose of this study is to examine the effect of PF-06305591 on capsaicin and~     capsaicin/heat-induced neurogenic flare.~   "
96210|NCT01797783|"~     The purpose of this study was to demonstrate substantial equivalence of the new DAILIES®~     AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus®~     DAILIES® Progressives (FDP) contact lens.~   "
96211|NCT01797770|"~     This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal~     Surgery. In this trial patients with left sided colon and rectal tumors were randomized to~     receive mechanical bowel preparation or no preparation to assess postoperative complications~     and outcome~   "
96212|NCT01797757|"~     A potential application for unstructured monoacylglycerol (MAG) containing long chain~     polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who~     chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed,~     it is predictable that chronic consumption of Orlistat® led to a depletion of essential~     fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a~     source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects~     with other type of maldigestion/malabsorption. Potential applications of such concept are~     therefore related to disease conditions comprising low lipid digestion due to lipase~     activity insufficiency.~      In the present study, in order to see the response information for eicosapentanoic acid~     (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as~     triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under~     Orlistat® consumption will be analyzed.~   "
96213|NCT01797744|"~     Recently, the investigators has shown that dizziness is common among patients with first~     time stroke and that it affects self perceived health. There are indications that vestibular~     rehabilitation can have effect of neurological causes of dizziness and vertigo and it~     therefore seems important to find out if vestibular rehabilitation can affect dizziness~     among patients with stroke.~      The aim of this study is to find out if vestibular rehabilitation can have any effect on~     function, balance and self-rated health among patients with first time stroke.~   "
96214|NCT01797731|"~     This is a randomized, controlled, blinded prospective study comparing the use of the usual~     cutting guides with a palm-sized digital surgical navigation system in unilateral total knee~     arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment~     of the tibial (shinbone) implant components. The investigators expect that the FDA-approved~     hand-held surgical navigation device will increase the accuracy and precision of the tibial~     cut by telling the surgeon the exact position of the cutting block before the surgeon makes~     the cut, allowing minor adjustments to be made. The investigators expect the conventional~     device to take less time to use, but that this difference will decrease as the surgeon~     becomes more familiar with the device. The investigators expect the intraoperative~     measurements acquired by the KneeAlign system to strongly correlate with the radiographic~     alignments measured postoperatively.~   "
96217|NCT01797692|"~     This is a multicenter pilot study, proposed for cases and controls 3 departments in France.~      Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are~     healthy subjects selected by lottery on voter list.~      Volunteer subjects (cases and controls) are offered a consultation and assessment with an~     geriatrician.~   "
96218|NCT01797679|"~     This study is the radiological component of an earlier registered RCT under the title:~     Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee~     Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy~     of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the~     articular cartilage. It has been proven that exercise can improve function and reduce the~     need for analgesics in patients with osteoarthritis. With this study, we wish to investigate~     if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation~     times of the articular cartilage, and also if this improvements are transient or permanent.~   "
96219|NCT01797666|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc.~     Dosing periods of studies were separated by a washout period of 12 days and 11 days~     respectively.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
96220|NCT01797653|"~     Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with~     obstructive sleep apnea (OSA) to define the physiological effects of continuous positive~     airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal~     microvascular function during a 2 week period.~   "
96221|NCT01797640|"~     Currently, the treatment of choice for tibial fracture is intramedullary nailing. This~     procedure has been shown to have low rates of infection, high rates of bone healing, and a~     faster return to weight bearing and activity in comparison to conservative treatment. In~     concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to~     identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the~     tibia. In this retrospective study, our aim is to establish that reducing malleolar~     fractures prior to tibial nailing is a safe treatment in which the reduction of the~     malleolus is maintained intraoperatively, postoperatively, and remains reduced until the~     fracture has healed.~   "
96222|NCT01797627|"~     This multicenter, prospective study of children with hydrocephalus will examine whether or~     not ventricle size is associated with poor cognitive outcomes. It is expected that results~     will indicate larger ventricular size at 6 months after surgery for the initial treatment of~     hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the~     Hydrocephalus Clinical Research Network (HCRN), a network established to conduct~     multi-institutional clinical trials on pediatric hydrocephalus.~   "
96223|NCT01797614|"~     Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is~     studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can~     also reflect the change of pulmonary dynamics. In this study, we choose patients who~     received spontaneous breathing trial to answer the hypothesis.~   "
96224|NCT01797601|"~     The purpose of the study is to investigate whether insulin sensitivity and insulin~     resistance of the human brain is comparable in all insulin sensitive parts of the brain and~     whether correlates to other phenotypic information (i.e. whole body insulin sensitivity,~     BMI, age) of the study participants.~   "
96225|NCT01797588|"~     Effective pain management following total knee arthroplasty is important to facilitate early~     mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia,~     including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used.~     However, local anesthetics injected into the femoral nerve area may cause a block in motor~     function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed~     pre-operatively, and periarticular infiltration performed intra-operatively are effective in~     reducing pain following TKA without causing quadriceps motor block which can impede~     mobilization. No published trials have been found that compare single shot adductor-canal~     block plus periarticular infiltration to periarticular infiltration only or adductor-canal~     nerve block only. The purpose of this trial is to examine the effect of 3 different~     approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2)~     adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic~     consumption, mobility, pain related interference with activities and length of hospital stay~     in participants undergoing unilateral TKA. Patients will be eligible for participation if~     they are 18 years old or older, and can speak, and read English. Ninety-six trial~     participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part~     of their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and~     length of stay will be calculated in hours after the participant is discharged to home. It~     is hypothesized that participants that receive both adductor-canal nerve block plus~     periarticular infiltration will report less pain, improved mobility and less pain related~     interference with activities.~   "
96226|NCT01797575|"~     We propose to conduct a double-blind placebo-controlled trial with a widely available and~     prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC,~     involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed~     episode currently. This will be the first controlled study to test the hypothesis that~     aspirin and NAC, by themselves or in combination, will be beneficial in treating depression~     in bipolar disorder patients and in promoting mood stabilization.~      Our study has the following Aims:~      Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a~     double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating~     depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III -~     Examine efficacy of combined treatment with aspirin and NAC looking for synergistic,~     potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible~     mediators or modulators in therapeutic response in the treatment of depression in patients~     with Bipolar Disorder.~   "
96227|NCT01797562|"~     To evaluate the performance and safety of seven T.R.U.E. Test Panel allergens in subjects~     6-17 years of age with suspected contact dermatitis.~   "
96228|NCT01797549|"~     The goal of this project is to develop a test to assess frontal lobe function using a rapid,~     inexpensive, objective, and standardized method, without the need for expertise in cognitive~     test administration. Such methods would be particularly helpful in traumatic brain injury~     (TBI), where objective measures are needed, and would greatly expand the capacity to make~     such assessments in clinical practice and research.~   "
96229|NCT01797536|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir~     (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic~     insufficiency compared with healthy controls.~   "
96230|NCT01797523|"~     The goal of this clinical research study is to learn if the combination of everolimus,~     letrozole, and metformin can help to control recurrent or progressive endometrial cancer.~     The safety of this drug combination will also be studied.~      Everolimus is designed to block a protein inside cancer cells that is involved in cancer~     growth.~      Letrozole is designed to block a protein from making estrogen. This may interfere with the~     growth of cancer cells.~      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is~     designed to lower insulin levels, which may slow or stop the growth of endometrial cancer~     cells.~   "
96231|NCT01797510|"~     This study is designed to compare an intensive lifestyle and activity coaching program~     (&quot;Sessions&quot;) to usual care for diabetic patients who are sedentary. The question~     to be answered is whether the Sessions program improves clinical or patient centric~     outcomes.~      Recruitment is through invitiation only.~   "
96232|NCT01797497|"~     The overall goal of this three-year study is to adapt and test a brief, feasible~     intervention using a communication tool and brief parent coaching to increase the capability~     of parents of children and youth with special health care needs to exchange and use medical~     information in partnership with their child's physicians when their children require~     sub-specialty referral. We hypothesize that the use of tools to coordinate referrals between~     physicians and parents will facilitate increased communication between primary care~     physicians(PCPs) and specialists, and that parents trained in information exchange and care~     planning will experience increased self-efficacy in interacting with their child's~     physicians.~      There are two primary aims of the study. The first aim is to adapt a joint parent-provider~     referral communication and care planning intervention (i.e., the 'referral care plan') for~     use with ethnically diverse populations in an electronic communication environment, and~     optimize its usability in the practice setting. The second aim is to test the referral care~     plan in nine pediatric primary care and subspecialty practices in two states, using a~     stepped wedge cluster randomized trial, to evaluate its effect on communication, parent~     self-efficacy, and patient outcomes.~   "
96233|NCT01797484|"~     The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in~     acute myocardial ischemia.~      A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic~     myocardium in patients with stable coronary artery disease can be reduced by~     Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or~     dysfunctional myocardium in SPECT-examinations.~      The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to~     the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the~     grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection~     fraction).~      In patients with stable angina pectoris, Ranolazine is used with beneficial results1.~     Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by~     reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload).~      Recently published data2 showed that treatment with Ranolazine significantly reduces the~     ischemic area in chronic damaged myocardium. This is due the effect of improved~     microcirculation in hibernating myocardium.~      Early administration of Ranolazine and improvement of microcirculation in patients with~     acute damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment~     and re-uptake of cardiac activity of hibernating myocardium.~      For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment~     to reduce the area of acute ischemic myocardium.~      Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of~     myocardial dyskinesia and angina pectoris in the patient history will receive unaltered~     guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be~     performed to stabilize patients to a hemodynamically compensated state and patients are then~     transferred to receive cardiac catheterization (angiography and angioplasty if necessary).~      After patients are stabilized Ranolazine will be given additionally to guideline based~     medication.~      The measurement of the ischemic myocardial area will be done via three functional~     echocardiographies with speckle tracking technique10.~      A statistical evaluation of ischemic myocardial area before and after treatment with~     Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of~     Ranolazine in acute myocardial ischemia.~   "
96234|NCT01797471|"~     The investigators aim to evaluate the safety of delivering a one-time single fraction of~     Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose,~     conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in~     patients with bulky stage III non-small cell lung cancer in the setting of a single-arm~     phase I clinical trial. The investigators hypothesize that the addition of a one-time single~     fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity~     above that expected with standard-dose concurrent chemotherapy and radiation alone.~   "
96235|NCT01797458|"~     The purpose of this randomized clinical trial is to compare the clinical effectiveness of~     three treatments involving different caries management strategies (conventional~     restorations, Hall technique, and a non-restorative treatment of dental caries) to the~     management of class II carious primary molar in children 3-8 year-old from three different~     countries (Scotland, Lithuania, and Germany).~   "
96236|NCT01797445|"~     This study will evaluate the efficacy and safety of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose~     combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate~     (Stribild®; E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.~   "
96237|NCT01797432|"~     The investigators hypothesize that Restylane® could serve as a repair matrix which also~     maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of~     time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting~     the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with~     IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the~     prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone~     acetonide for longer periods of time, patients may see a better clinical response for a~     longer period of time. Quality of life may improve as the number of clinic visits decreases~     as would the number of IL corticosteroid injections.~   "
96238|NCT01797419|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     GS-5806 in hospitalized infants with RSV.~   "
96239|NCT01797406|"~     Water injection colonoscopy has been a generally accepted method in training the beginners~     of colonoscopy for its low pain and less cecal intubation time, the investigators would~     conduct this study to investigate advantages of this method for experienced endoscopists.~   "
96240|NCT01797393|"~     Up to now, many studies has showed that compared with air insufflation colonoscopy,~     water-related colonoscopy could shorten the cecal intubation time and relieve the pain of~     the patients,especially for training the beginners,the investigators conduct this study to~     preform the air assisted water injection colonoscopy in experienced endoscopists.~   "
96241|NCT01797380|"~     To determine the efficacy of escitalopram in treating depression in HIV seropositive women.~   "
97089|NCT01786200|"~     This prospective pilot study will examine whether the previously reported effects of NSAIDs~     on colorectal cancer may be modulated through alterations in tissue gene expression, up~     regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory~     response.~   "
96242|NCT01797367|"~     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500~     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate~     of decrease in lung function over time compared to waiting to start ART until the CD4+ drops~     below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and~     both human immunodeficiency virus (HIV) infection and ART have been shown to case a decline~     in lung function as well. Decline in lung function can be an early indicator of chronic~     obstructive pulmonary disease (COPD), a significant cause of sickness and death in people~     with HIV. In this study, lung function will be measured at baseline and every year~     thereafter by using a spirometer.~   "
96243|NCT01797354|"~     Background: The end of treatment is for cancer patients the beginning of a critical~     rehabilitation period including numerous physical, emotional, professional and cognitive~     challenges. Specific interventions adapted to this post-treatment period need thus to be~     designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been~     shown to be effective. However, moderate effect sizes, no comprehensive description of the~     treatment interventions and assessments relying only on self-report measures warrant further~     investigation. This study aims to assess, in breast cancer patients at the end of treatment,~     the impact of a group intervention combining cognitive-behavioral therapy and hypnosis~     versus a group intervention on patient's adjustment and emotion self-regulation.~      Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer~     patients finishing their radiation therapy treatment will be randomized to either an~     immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group~     intervention. Patients will be assessed at three time points during the first year following~     the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment.~     Patients' adjustment will be assessed through questionnaires. Patient emotion~     self-regulation ability will be assessed through their ability to respond both subjectively~     (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation~     tasks.~      Discussion: It is hypothesized that a group intervention combining cognitive-behavioral~     therapy and hypnosis will be more effective than a group intervention. Results of this study~     will contribute to improving post-treatment care for breast cancer patients.~   "
96244|NCT01797341|"~     The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on~     renal function, trough tacrolimus levels, drug-related adverse effects and adherence in~     stable recipients of kidney-pancreas transplants. MPA pharmacokinetics will also be~     evaluated. The results of this study have the potential to change current practice.~   "
96245|NCT01797328|"~     About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of~     ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for~     determination of brown adipose tissue volume) imaging are performed before and after the~     study.~   "
96246|NCT01797315|"~     Transplant recipients have a high risk to develop skin malignancies. This effect depends on~     the one hand on the immunosuppressive drugs themselves and relates on the other hand on the~     dosage. Based on the encouraging results of previous, retrospective studies on patients~     treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive~     regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from~     former immunosuppression. A conversion to a SRL-based therapy is effective in~     immunosuppression and safe regarding graft and patient survival.~      This study was designed to assess whether a switch to a SRL-immunosuppressive therapy~     decreases the incidence/reoccurrence of skin neoplasm.~   "
96247|NCT01797302|"~     In this study, we will test the central hypothesis that enhancement of vitamin D status in~     obese and overweight children will improve their vascular health and their cardiovascular~     disease (CVD) and metabolic syndrome risk profile.~   "
96248|NCT01797289|"~     All patients consecutively referred with the first episode of transient and short-lasting~     loss of consciousness will have a diagnostic workup for the assessment of the most common~     causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with~     the use of an internationally accepted algorithm including a pre-test clinical probability~     (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer~     assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will~     undergo confirmatory diagnostic tests (either computerized tomography or~     ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.~   "
96249|NCT01797276|"~     Open Label access to DCA as continued treatment for congenital lactic acidosis.~   "
96250|NCT01797263|"~     The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm~     parallel group, randomized clinical trial to compare the effectiveness of a yoga-based~     intervention (YOGA) with that of a structured exercise program (SEP) for subjects with~     fibromyalgia. The study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on~     overall fibromyalgia severity at 1 month (early response), 3 months (immediate~     post-intervention) and at 6 and 9 months (sustained effects); 2) to compare the~     interventions effects on specific fibromyalgia symptoms (pain, sleep, and fatigue),~     functional impairment, and related outcomes (quality of life, psychological symptoms); and~     3) to compare the cost-effectiveness of the interventions.~   "
96251|NCT01797250|"~     To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject~     population~   "
96252|NCT01797237|"~     The purpose of this study is to determine whether this two intramedullary fixations are~     effectively in the treatment of intertrochanteric fracture.~   "
96253|NCT01797224|"~     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and~     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic~     effect of these medications and to follow live born infants for five years after birth. With~     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be~     relevant to a medication exposure during pregnancy, and these include both easily~     recognizable defects which are visible at birth, as well as more subtle or delayed defects~     that may not be readily identifiable without special expertise and observation beyond the~     newborn period.~   "
96254|NCT01797211|"~     To assess the effect of Mediterranean diet and some of its specific components (olive oil,~     non fried fish and nuts) on endothelial function in overweight and obese patients~   "
96255|NCT01797198|"~     ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a~     two-part study to investigate the drug-drug potential of ASP3652.~      Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of~     ASP3652.~      Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of~     repaglinide.~      Subjects participating in one part of the study may not participate in the other part.~   "
96256|NCT01797185|"~     Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis~   "
96257|NCT01797172|"~     Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral~     medications. Once these treatments have failed, different alternative procedures can be~     applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical~     Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of~     thermal damage. A variety of published studies have demonstrated this treatment to be both~     safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is~     also a popular type of pain treatment. The application of PRF is also a safe and useful~     intervention for neck pain. Although these treatment types are described in the literature,~     the available evidence for efficacy is not sufficient to allow definitive conclusions on the~     optimal therapy to be made. The purpose of this study is to investigate which technique is~     the most effective in terms of pain relief on short term in patients with contained cervical~     disc herniation: PCN or PRF?~   "
96258|NCT01797159|"~     The Investigators are looking to compare standard treatment for the management of small cell~     lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in~     patient survival) with cranial sparing PCI. Although standard of care PCI is successful in~     patient survival it also has neurologic side-effects. The Investigators are hoping the~     cranial sparing PCI has the same positive survival results with the added benefit of~     lowering neurological side-effects.~   "
96259|NCT01797146|"~     The investigators will conduct a cluster randomized controlled trial to evaluate the~     efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of~     catheter use and the number of infection relating to catheter use.~   "
96260|NCT01797133|"~     We will conduct a cluster randomized controlled trial to compare two antibiotic~     pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and~     duration of antibiotic consumption would be lower in the pharmacist group while the clinical~     outcome would be equivalent between two groups.~   "
96261|NCT01797120|"~     Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer~     resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant~     (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).~      Fulvestrant has demonstrated activity when used as first, second, or third line endocrine~     therapy, making it an attractive therapy for combination with other agents. In addition, it~     is commonly reserved for use following disease progression on AI therapy.~      Everolimus is an orally administered drug that blocks a signaling pathway called mTOR.~     mTOR acts as a regulator for many processes in the body, including cell growth. Blocking~     this pathway may have an effect on cell growth.~      The combination of a novel class of agents (mTOR inhibitors) and an established standard~     treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by~     targeting multiple different biological pathways.~   "
96262|NCT01797107|"~     The purpose of this study is to evaluate the effect of Azasite on patients with corneal~     surface irregularity (meibomian gland dysfunction).~   "
96263|NCT01797094|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the~     treatment of upper facial lines (Crow's Feet Lines and Frown Lines).~   "
96264|NCT01797081|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared~     to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).~   "
96265|NCT01797068|"~     A large proportion of frequent ED users have Medicaid insurance. The purpose of this study~     is to evaluate the effectiveness of patient navigation for reducing Emergency Department~     (ED) visits and hospitalizations and improving patient-centered outcomes (e.g.,~     self-reported health status, quality of life, access/barriers to care) among Medicaid~     patients who are high utilizers of the ED, as well as to identify best practices for~     engaging and providing healthcare services to underserved patients using patient navigation.~     This study will address needs that have been identified within the New Haven community and~     the local healthcare system, contribute to knowledge and literature surrounding the use of~     patient navigation to improve care for underserved patients and improve health system~     efficiency, and inform the design and development of programs that address these needs both~     locally and in other communities.~   "
96266|NCT01797055|"~     Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein~     transferrin. No regular treatment is available for these patients. The objective of this~     study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin~     replacement therapy in atransferrinemia patients.~   "
96267|NCT01797042|"~     The purpose of this study is to investigate the acute and chronic effects of consumption~     fructose containing sugars and glucose in a real word setting when consumed in a manner and~     amount typical in the American diet.~   "
96289|NCT01796756|"~     Miscommunication during patient handover can jeopardize patient safety and is the focus of~     Quality Improvement initiatives by many organizations. It is widely recognized that such~     miscommunication is preventable using a number of strategies identified in the literature.~      Currently, there is no formal handover process of General Internal Medicine in-patients,~     otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is~     a major patient safety concern. This project will implement a formal handover program and~     evaluate whether there are changes in resident satisfaction with handover, but more~     importantly, whether the investigators can improve patient outcomes.~   "
96292|NCT01796717|"~     1. To observe clinical and bacteriologic responses of different regimens of~          piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of~          nosocomial pneumonia.~        2. To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged~          or intermittent infusion) in patients with nosocomial pneumonia.~        3. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or~          intermittent infusion in patients with nosocomial pneumonia.~   "
96268|NCT01797029|"~     This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial~     of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated~     influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.~      Background:~        1. Burden: Within Bangladesh, community- based influenza surveillance identified 84.5~          cases/1000 children-years among children <5 years, while 10% of clinical pneumonia~          cases were influenza positive in this age group.~        2. Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL~          LAIV vaccine conducted among children in a low-income country.~        3. Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high~          efficacy against laboratory-confirmed influenza among children. The SIIL LAIV has the~          potential to be an inexpensive intervention to prevent pediatric influenza disease.~      Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious~     in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains)~     among children vaccinated with LAIV as compared to children vaccinated with a placebo~     through the first influenza season following vaccination.~      Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic,~     laboratory-confirmed influenza virus infection (vaccine-matched strains) among children~     receiving LAIV as compared to children receiving a placebo through the first influenza~     season following vaccination (through December 2013).~      Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to~     placebo beginning in March 2013. After vaccination, all children will be evaluated for~     reactions with one home visit four days post vaccination. Subsequently, all children will be~     monitored weekly for safety outcomes and illness signs at weekly field worker home visits~     through December 2013. An extended surveillance period was added to this study and, for~     participants consenting to additional follow-up, surveillance will extend through a second~     season (through September 2014). Participants with illness signs will be referred to the~     study clinic for evaluation using standardized diagnostic criteria and treatment by a study~     physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have~     a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time~     polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.~      Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic,~     laboratory-confirmed influenza for all circulating virus strains.~   "
96269|NCT01797016|"~     This project aims to refine previous studies including the investigators work recently~     published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a~     relationship between the level of platelet leukocyte aggregates in patients with acute~     coronary syndrome. The investigators intend to compare the characteristics of platelets,~     monocytes and neutrophil data of volume, scatter and conductivity obtained from routine~     blood count level with flow cytometry results defining platelet leukocyte aggregates. The~     investigators hypothesize that there will be a direct correlation between elevated~     platelet-leukocyte aggregates and biophysical data from the blood count.~   "
96270|NCT01797003|"~     Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for~     treatment of medial knee osteoarthritis.~      Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation.~     We will compare functional results and patient satisfaction with repetitive evaluations from~     preoperatively to 2 years postoperatively.~   "
96271|NCT01796990|"~     The main objective of the study is to provide data of the effectiveness and feasibility of~     the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among~     sedentary adults. The psychological and motivational factors related to physical activity~     and behavior change will also be evaluated.~   "
96272|NCT01796977|"~     This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound~     complication rates of the nipple areolar complex after a nipple sparing mastectomy.~   "
96273|NCT01796964|"~     The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in~     the treatment of exudative age-related macular degeneration.~   "
96274|NCT01796951|"~     Regular aspirin use has been associated with a reduction in the development of a number of~     different malignancies including lung cancer. The mechanism of aspirin's cancer prevention~     is not known. This study will evaluate whether once daily aspirin use can reduce the~     production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer.~     Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by~     blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants~     will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of~     both during various days of this 16-day study. Urine be collected to evaluate for PGE-2~     production at 4 timepoints in this 16-day study.~   "
96275|NCT01796938|"~     To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired~     subjects and healthy subjects.~   "
96276|NCT01796925|"~     The objective of the study is to confirm the safety and efficacy in patients utilizing the~     aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).~   "
96277|NCT01796912|"~     Angina which is refractory to conventional medical therapy and revascularisation is~     challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of~     LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse~     cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic~     effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most~     effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to~     no effect on Lp(a) levels.~      The goal of this study is to determine the impact of apheresis on clinical parameters and~     symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct~     a prospective, randomised controlled crossover study of 20 patients with refractory angina~     and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or~     sham apheresis weekly for three months with assessment of myocardial perfusion, carotid~     atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina~     symptoms and quality of life at the beginning and end of treatment. Patients will then~     crossover to the opposite study arm with the protocol repeated. The hypothesis is that the~     above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and~     Refractory Angina. Investigators will also test for the genotypic presence of~     apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to~     be associated with an increased level of Lp(a) and an increased risk of coronary disease.~   "
96278|NCT01796899|"~     To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50~     mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.~   "
96290|NCT01796743|"~     A novel Cardiac MRI sequence, developed by Dr. Maria Altbach (Double Inversion radial fast~     Spin Echo T2 mapping), has been tested clinically. It demonstrated a high sensitivity to the~     heart muscle swelling (edema) in different types of heart injury, including heart attacks.~      The investigators propose to use T2-Map methodology in patients with acute heart attacks and~     to compare value of this method with other clinical and imaging parameters in predicting~     short-term (30 day) clinical outcomes of these patients.~      If successful, the project will provide an effective risk-stratification tool to identify~     patients with heart attack as a result of atherosclerotic disease, who require more~     aggressive therapeutic approach and closer follow-up after initial hospitalization.~   "
96279|NCT01796886|"~     The pupillary examination is a major component of the clinical examination and monitoring of~     brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary~     reactivity is a prognostic factor of poor neurological outcome or an indicator of the~     neurological status degradation. To date, the monitoring of the pupils is clinical. The~     subjectivity of this measure and, the lack of reproducibility and definition of the~     abnormality remain as many obstacles to the development of a monitoring of early~     neurological deterioration. The recent development in pupillometer electronics allows the~     assessment of responsiveness to a calibrated light stimulus. It offers a reliable and~     reproducible measure of the pupil diameter. The pupillometers were funded by the association~     of  Gueules Cassées .~      This study aims to establish a relationship between an abnormal pupillary reactivity~     detection by the electronic pupillometer and a deterioration in neurological status of the~     patient brain-damaged in the intensive-care unit (ICU). This is considered clinically~     relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours~     or involving a therapeutic action. If this relationship is demonstrated, the temporal~     relationship between data pupillometry and the patient's neurological status remain to be~     established more precisely. This is particularly relevant in neurosurgical context and aim~     to define the status of the electronic pupillometer in intensive care but also in emergency~     rooms services, the neurovascular units or in the pre-hospital care.~      Therefore the investigators will compare the pupillometry data in two patients groups,~     defined accordingly to the appearance or absence of neurological aggravation in the first 5~     days of treatment in intensive care, time-frame defined as the maximum risk period in~     patients with brain damage. The primary endpoint is represented by the estimated area under~     the ROC curve corresponding to the last measure of the change in pupil size before the onset~     of neurological deterioration and worse for the fifth day for non-aggravated.~      Thus the investigators propose to conduct a prospective trial, aiming to record the~     diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of~     the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up~     for a subject does not exceed 5 days. The statistical analysis requires the recruitment of~     90 patients, which sets the length of the inclusions to 14 months.~   "
96280|NCT01796873|"~     Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to~     reduce the risk of having another heart attack by preventing platelets (blood cells that are~     important in forming blood clots) from sticking together and forming another clot. Platelet~     activity can be measured by a machine called VerifyNow.~      The purpose of this study is to see whether Hispanic women and White non-Hispanic women have~     the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies~     have shown that platelets may be more active in Hispanics, making it more difficult to~     prevent clots from forming, even when using Plavix. In addition, studies have shown that~     women may also have more active platelets than men. There have been no studies of Hispanic~     women and the effect of Plavix on platelet activity.~   "
96281|NCT01796860|"~     The purpose of this study is to investigate the impact of a specifically designed ankle foot~     orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and~     temporal gait parameters, electromyography (EMG), and walking endurance, in select~     individuals living with MS. This orthotic is fabricated to allow ankle range of motion~     required for normal gait kinematics. Additionally, it controls forward progression of the~     tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who~     are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters~     2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance,~     and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing~     profiles/EMG measures.~   "
96282|NCT01796847|"~     Glycemic variability in critically ill patients is a recognized negative prognostic factor.~     The molecular mechanisms determining inter-patients variability in glucose metabolism during~     stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to~     influence glucose homeostasis by interfering in intracellular insulin signaling.~      Aim of this study is to ascertain whether differential expression of PTEN in critically ill~     patients correlates with glycemic variability and clinical outcome.~   "
96283|NCT01796834|"~     To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction~     (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure,~     perceived stress, depression, patient self-efficacy and quality of life; and to estimate the~     effect of a MBSR program for patients with DM. It is expected that MBSR program participants~     will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and~     standardized measures of diabetes self-management, perceived stress, depression,~     self-efficacy, and quality-of-life.~   "
96284|NCT01796821|"~     To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated~     baseline EGW(s) on the treated area.~   "
96285|NCT01796808|"~     It is believed that the average person with an eighty year old life span will walk the~     distance of the world twice in their lifetime. The foot is comprised of a specialized fat~     pad to provide shock absorption and protection against breakdown. With all the walking~     humans do however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in~     the diabetic patients due to many reasons: loss of protective sensation secondary to~     neuropathy, reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars~     and increased body weight to name a few. Increased foot pressure and decreased fat pad~     protection are the main contributing factors to callus formation, foot pain and ulcer~     formation.~      Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help~     improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is~     a procedure using a patient's own fat that is taken by a small liposuction tube, from areas~     with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat~     atrophied (decreased or worn out) area (in this case, the foot).~      The investigators are performing this research in an effort to decrease foot pressure during~     activity and to increase the soft tissue thickness of the sole of the foot during one's~     lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer~     formation. The goal of this research is to see whether fat grafting will help decrease the~     prevalence of the aforementioned foot complications. The investigators hope that by using~     one's own fat tissue, he or she may have a longer duration of relief than by using other~     methods.~      This is a randomized, cross-over designed study. Randomized means that patients will be~     enrolled by chance (like the flip of a coin) to one of two groups for the first part of the~     study. Cross-over means that, after the first part of the study or at one year, patients~     will move into the opposite group. One group will receive the fat grafting procedure with~     one year follow up (year A pathway) and the other will receive standard of care treatment~     from the patient's primary podiatrist during the first year (year B pathway). After the~     first year, patients will switch to the opposite year pathway for the next 12 months.~     Participation in this study will last approximately 24-26 months.~   "
96286|NCT01796795|"~     This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of~     target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant~     extract) in patients with CW.~   "
96287|NCT01796782|"~     Primary End Point:~      - To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy~     in patients with metastatic pancreatic cancer.~      Secondary End Points:~        -  Compare clinical efficacy by other measures including PFS,tumor response,and changes in~          quality of life (QOL) between these two groups.~        -  Examine the feasibility and assess the side effects of treatment using QYHJ Granules in~          patients with metastatic pancreatic cancer.~   "
96288|NCT01796769|"~     Targeted population:~      Sleep apnea patients at low cardiovascular risk newly treated by CPAP~      Hypothesis:~      Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP~     care.~      Main goal:~      To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are~     randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based~     on a telemonitoring web platform.~   "
96293|NCT01796704|"~     The study hypothesizes that an assumed cardiovascular performance reserve is physiologically~     detectable.~      High reserve at rest characterizes a healthy person while low reserve at rest characterizes~     low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.~      The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed~     by an algorithm composed of physiological measurements taken during the patient visit.~      In this study the investigators evaluate CVRI capability in prediction of functional~     capacity in comparison with the clinical evaluation during the same visit.~   "
96294|NCT01796691|"~     Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.~   "
96295|NCT01796678|"~     Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD).~     Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of~     emergency department visits. Currently efforts to treat painful episodes with use of~     non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only,~     without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that~     an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since~     arginine is the obligate substrate for NO production, and an acute deficiency is associated~     with VOE, investigators hypothesized that arginine supplementation may be a safe and~     beneficial treatment for sickle cell pain.~   "
96296|NCT01796665|"~     The objective of this study was to evaluate the efficacy and safety of Perrigo's test~     formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to~     the already marketed formulation, Acanya gel in patients with acne vulgaris.~   "
96297|NCT01796652|"~     Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied~     the feasibility of home management in AP.The aim of study was to compare 30 day readmission~     rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home~     monitoring versus hospitalization.~   "
96298|NCT01796639|"~     The primary objective of this study is to evaluate graft survival and recipient survival~     among kidney transplant recipients in China, and also to analyze possible factors related to~     patient and graft survival.~      The secondary objective is to evaluate several secondary outcomes among kidney transplant~     recipients, such as average creatinine value, acute rejection episodes, NODM, incidence of~     BKV infection etc. At the same time analyze possible impact factors related to these~     secondary outcomes.~   "
96299|NCT01796626|"~     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2~     clinical sites; each clinic will enroll at least 15 subjects.~      Subjects should present visible wrinkles and/or striae requiring treatment.~      Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at~     least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at~     least 50% using VAS as compared to baseline, for at least 75% of the subjects.~   "
96300|NCT01796613|"~     The study is a multidisciplinary research project and has two main aims:~        1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an~          emphasis on its effect on the vaginal microenvironment after different durations of~          use: the vaginal microbiome, biofilm formation on epithelial cells and rings,~          inflammation and immune activation in the vagina~        2. To investigate the feasibility, acceptability and adherence to vaginal ring use in~          Rwandan women, including attitudes towards a future multi-purpose vaginal ring for~          prevention of both pregnancy and sexually transmitted infections (STI).~   "
96301|NCT01796600|"~     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.~     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for~     an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the~     cone-beam scanner could detect and characterize fractures of the extremities similarly to a~     multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected~     distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis~     based on the ability of cone-beam scanner to properly characterize the type of fracture~     using a classification derived from Maurice E. Müller (AO) classification. Secondary~     endpoints will concern the depiction of the fracture, the assessment of the soft tissues~     near the fracture, quality of images, inter and intra-operator reproducibility and tolerance~     of the patient for the examination. Patients will have a MDCT considered as the reference~     exam, then a CBCT. Exams will be anonymized and read twice by two trained radiologists with~     3-6 week intervals. The inter-observer agreement for the diagnosis of fracture type between~     the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic~     performance will be achieved by studying the sensitivity, specificity, negative predictive~     value and positive predictive value, and its likelihood ratio. Kappa test will be performed~     to evaluate the consistency of the characterization of the fracture and the evaluation of~     soft tissue near the fracture. A Student t test will be performed for paired data if~     distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the~     percentages of (painful, not painful) will be calculated for each technique and will be~     compared using the Chi2 test (or Fisher's exact test if the chi can not apply).~   "
96302|NCT01796587|"~     Primary objective: To evaluate compliance of LoFric Origo in a general intermittent~     catheterization (IC) population with the use of LoFric Origo, by means of a subjective~     assessment scale~      Secondary objectives:~        -  To evaluate the subject's perception associated with the use of the LoFric Origo, by~          means of a subjective assessment scale~        -  To evaluate the subject's discomfort associated with the use of the LoFric Origo, by~          means of a subjective assessment scale~        -  To observe and collect data on bladder regimen/IC frequency by assessments of~          descriptive data of demography, catheter therapy, history and other patient reported~          outcomes.~      Study Design: Non-interventional study, multicentre, prospective study. Target Subject~     Population: General intermittent catheterization, LoFric Origo male users.~      Medical Device: LoFric Origo~      Study Variable(s):~        -  Primary variable: Use or No use of LoFric Origo after 8 weeks.~        -  Secondary variable(s): patient reported questionnaire with regards to perception,~          discomfort, diagnose, health status, catheter history and other patient reported~          outcomes.~   "
96303|NCT01796574|"~     This research is being done to observe the safety, tolerability, side effects, and~     effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus)~     being treated in a neurointensive care unit.~   "
96324|NCT01796301|"~     This is a multi-center, randomized, open-label, TPTD-controlled study in postmenopausal~     women with osteoporosis at high risk for fracture.~   "
96451|NCT01794689|"~     Twenty percent of Americans suffer from chronic pain. Sleep disturbance is similarly~     prevalent and among the most common and disabling neurobehavioral problems associated with~     chronic pain. This research is designed to evaluate the effects of disrupted sleep patterns~     on mood, inflammation, the perception of pain, and pain relief. This study will help~     researchers understand the relationship between sleep and pain, and how sleep disturbance~     might influence chronic pain conditions.~   "
96304|NCT01796561|"~     Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all~     deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation~     2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD~     risk doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in~     BMI and waist circumference has been associated with an increase in blood pressure. The~     leaves of the olive plant are rich in plant compounds known as polyphenols. This particular~     group of polyphenols are known secoiridoids, which are also present in olive oil and olives~     though at lower concentrations, are only found in this family of plants. Diets high in~     polyphenols have been found to reduce the risk of chronic diseases. Studies have shown that~     consumption of phenolic-rich olive leaf extract (OLE) can significantly reduce blood~     pressure in individuals suffering from high blood pressure (hypertension), with the~     magnitude of effect being comparable to a commonly used antihypertensive drug. In such~     trials OLE also resulted in an improved blood lipid (a reduction in total and LDL~     cholesterol and triacylglycerides) which also reduces CVD risk. One study testing the effect~     of OLE on individuals with mild or prehypertension (i.e. those with systolic blood pressure~     in the range 121-139 mmHg and diastolic blood pressure in the range 81-89 mmHg but not~     taking antihypertensive medication) also found these same improvements. OLE has been~     indicated to have the potential to improve other cardiovascular risk markers such as~     vascular function, inflammation, platelet aggregation, oxidation of LDL and glucose~     tolerance however much of this evidence is derived from animal, in vitro and ex vivo studies~     and so well designed and controlled human studies are required to verify that these findings~     are applicable to humans. Therefore OLE supplementation may be a useful dietary strategy for~     reducing CVD risk in a cohort of overweight prehypertensive individuals.~      The aim of the study is to determine the effect of OLE intake on blood pressure and other~     CVD risk markers in overweight subjects with mild hypertension and to link any study~     outcomes with the presence of OLE phenolics in urine~   "
96305|NCT01796548|"~     The purpose of this study is to evaluate the effects and tolerability (how well a~     participant can stand a particular medicine or treatment) of flexible dose Oxybutynin~     Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in~     participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor~     muscle do not work properly leading to frequent feeling of need to urinate during the day,~     night, or both).~   "
96306|NCT01796535|"~     This is a multi-center, non-randomized post marketing surveillance registry including up to~     125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation~     at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an~     Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits~     should be per standard of care.~   "
96307|NCT01796522|"~     Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as~     maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless,~     there is insufficient evidence to justify its routine use. The present study aims to~     evaluate the efficacy and safety of these tocolytic drugs for maintenance tocolysis in the~     management of threatened preterm delivery.~      Materials and methods:~      Phase III clinical trial, which evaluates the efficacy and safety of nifedipine and~     progesterone as maintenance tocolytic therapy until the 34th week of pregnancy in randomized~     women after an episode of threatened preterm delivery.~      Pregnant women with singleton pregnancies are going to be evaluated, with intact membranes~     and cervical length less than or equal to 25 mm, which have received acute tocolysis with~     atosiban. They will be randomized to receive maintenance tocolysis with nifedipine (60 mg /~     day orally) or progesterone (200 mg / day vaginally) until week 34 of gestation. Therefore~     all included patients will receive treatment with proven but not agreed efficacy, to~     decrease the recurrence of threatened preterm delivery, prolongation of gestation and~     subsequent better perinatal outcome. During the course of pregnancy, patients will be~     monitored in outpatient obstetrics, thus checking an adequate compliance. Monitoring will~     continue until the end with the delivery and collection of newborn data.~      The study will be single-blind, since there will be a blind evaluator. The drugs or~     treatments not allowed before and / or during the clinical trial are those which are~     indicated in the data sheet for each drug. If the patient takes antihypertensive treatment~     and continues it during pregnancy, dose adjustment will be done if it is needed.~      Data will be collected in the case report data (CRD). The end of the test will be considered~     when the last recruited patient complete the gestation (delivered vaginally or cesarean),~     and all data from newborn are collected. If a serious adverse event occurs in a patient, the~     woman will immediately finish the clinical trial and will be followed until complete~     resolution of the episode.~      Treatment is going to be considered effective if the birth occurs after 37 weeks of~     pregnancy with satisfactory perinatal outcome. The drugs are going to be considered safe if~     they do not cause adverse events in pregnant women, or if they are not serious.~      Number of Subjects: 50 pregnant women~      Diagnosis and main criteria for inclusion and exclusion:~      Inclusion Criteria~        -  Pregnant women with singleton pregnancies and intact membranes which have passed an~          episode of threatened preterm delivery (uterine contractions with cervical change)~          successfully treated with atosiban as acute tocolytic therapy.~        -  Cervical length ≤ 25 mm. Exclusion Criteria~        -  ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to~          tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to~          tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption,~          fetal abnormality incompatible with life, fetal death) .~      Investigational product, dose and mode of administration: After a successful treatment of~     acute preterm labor with atosiban, is will be compared the safety and efficacy of~     maintenance tocolytic therapy with nifedipine 60 mg / day orally or progesterone 200 mg /~     day vaginally.~      Therapeutic group: C08CA05 Nifedipine. G03DA04 micronized progesterone.~      Route of administration: nifedipine orally. Progesterone vaginally.~      Dose: Nifedipine 60 mg / day. Progesterone 200 mg / day.~      Duration of treatment: From the resolution of acute episode of threatened preterm labor~     until 34 weeks of gestation.~      Reference treatment, dose and mode of administration: Current evidence questions the utility~     of maintenance tocolytic therapy. No reference treatment is currently defined.~   "
96308|NCT01796509|"~     Study Hypothesis:~      Critical illness is associated with long-term medical and psychological sequelae that can~     impact the professional and private life. The purpose of the present multicenter randomized~     controlled trial is to assess whether or not a medical, psychological and social follow-up~     improves quality of life of critically ill patients at one year after their discharge from~     intensive care unit (ICU).~      Primary Purpose:~      Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at~     one year after ICU discharge.~   "
96309|NCT01796496|"~     The purpose of this study is to analyze the effectiveness of a three manipulative therapy~     techniques in People with Chronic Low Back Pain.~   "
96310|NCT01796483|"~     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor~     functions in patients with Parkinson disease (PD). However, growing evidence suggests that~     STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al~     2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007;~     Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are~     still unclear. Two reasons might explain this. 1) From a theoretical point of view,~     cognitive models of executive control mechanisms are incomplete. 2) From a methodological~     point of view, investigating cerebral activity during STN-DBS is very limited because most~     techniques are incompatible with locally implanted electrodes.~      This project relies on a double opportunity to answer these questions offered by recent~     theoretical and methodological advances. First, investigations in healthy subjects (Jaffard~     et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory~     control, so far ignored, consisting in locking in advance movement triggering processes to~     prevent undesired automatic or anticipated responses to unattended stimuli. In other words,~     key processes of executive control may act tonically before stimulation occurs, calling~     brain imaging studies to look at proactive and not only reactive activations. Second, recent~     advances in EEG signal processing now allow suppressing from the electroencephalogram~     DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a~     non-invasive technique with the high temporal resolution necessary to disentangle proactive~     from reactive brain activity. To our knowledge, up to date no study has been published using~     EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this~     project is to identify the anatomo-functional origin of STN-DBS-induced executive~     dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from~     this first part of the project may help resolving other long-lasting issues. Indeed,~     reactivity as assessed by simple reaction time in non-implanted patients as well as~     impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication.~     Since the proactive activity related to executive, inhibitory, control may be supported by~     the noradrenergic (NA) system, the second purpose of this project is to test the original~     hypothesis according to which NA plays a central role in both akinesia and STN-DBS side~     effects.~   "
96311|NCT01796470|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of~     entospletinib and idelalisib. Participants will be enrolled who have one of the following~     hematological tumor types: chronic lymphocytic leukemia (CLL), follicular lymphoma (FL),~     mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or non-FL indolent~     non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/Waldenström~     macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma~     [MZL]).~   "
96312|NCT01796457|"~     This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of~     Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis~     B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive~     Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).~      This study will examine the balance between immune regulatory and effector responses in~     hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and~     NCT01369199) to define natural history and treatment outcome.~   "
96313|NCT01796444|"~     The recently randomized trial (ASCOG Z0011) support that among patients with limited~     sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and~     systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary~     lymph node dissection (ALND) did not result in inferior survival. These patients, therefore,~     are unlikely to benefit from further surgery that results in a longer period of~     hospitalization, higher costs and higher postoperative morbidity. This result has been~     written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.~      However, Limitations of Z0011, such as failure to achieve target accrual and possible~     randomization imbalance favoring the SLNB-alone group, must be considered. In the other~     hand, further testing in different country are needed.~      The investigators design and begin a prospective randomized multicenter phase III study of~     ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.~   "
96314|NCT01796431|"~     The purpose of the study is to look at the levels of three HIV medications: tenofovir,~     emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for~     14 days.~      The duration of the subjects involvement in the study will be up to 23 days plus a screening~     visit which will take place up to 4 weeks prior to the start of the study, and a follow up~     visit which takes place 16-22 days after the last dose of study medication.~      This study is not randomised which means that all participants will receive all study~     medications in the same order. The participant and the study doctor will know which study~     medications you are taking at all times during the study.~   "
96315|NCT01796418|"~     Diabetic nephropathy, the leading cause of end-stage renal disease in many countries, is~     characterized by high cardiovascular mortality and morbidity even in the early course of the~     disease. In addition, cardiovascular complication has been the most common cause of death in~     these patients. Thus, early detection and appropriate intervention for this highly common~     and critical complication is considered to play an important role in the management of the~     disease. In this regard, much interest has been focused on the early markers which can~     predict arterial diseases before the clinically apparent cardiovascular diseases. Recently,~     glowing evidence suggests that arterial stiffness as assessed by pulse wave velocity (PWV)~     may serve as a surrogate marker for future cardiovascular disease. In fact, increased PWV~     has been known to be independently associated with diabetic nephropathy in type 2 diabetes.~      Beraprost sodium (BPS) is a stable orally active prostacyclin (PGI2) analogue that has a~     potent vasodilatory and anti-platelet effect. Also, BPS has been suggested to improve a~     micro-vascular circulation through a reduction of red blood cell deformability. In addition,~     recent studies have demonstrated that BPS improves endothelial function through an increase~     in endothelial nitric oxide synthesis and NO synthase gene transcription. These beneficial~     effects of BPS have been known to reduce PWV in patients prone to cardiovascular diseases~     such as elderly, hypertension, or a history of cerebral infarction. However, the effect of~     BPS on arterial stiffness in patients with diabetic nephropathy remains elusive. Our study~     will address the effect of BPS on arterial stiffness by PWV in patients with diabetic~     nephropathy.~   "
96316|NCT01796405|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific disease. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different diseases. It~     also means that the FDA has not yet approved clofarabine for your disease.~      Clofarabine is a chemotherapy drug that has been used in the treatment of leukemia in~     children and adults. Information from other research studies suggests that this drug may~     also be effective in patients with LCH.~      The purpose of this study is to estimate the response rates of participants with recurrent~     LCH to clofarabine within each of two strata: a) low-risk participants with disease~     reactivation, and b) high-risk participants with risk-organ involvement.~      Other purposes are to estimate the progression-free survival after clofarabine treatment,~     estimate survival of participants with refractory multi-system LCH with risk organ~     involvement treated with clofarabine and to describe toxicities of clofarabine in~     participants with LCH.~   "
96317|NCT01796392|"~     The purpose of this research is to study an investigational medical device that is designed~     to produce lung volume reduction in diseased areas of the lungs in patients with severe~     emphysema.~   "
96318|NCT01796379|"~     Compared to end-stage heart failure, a patient's situation is usually greatly improved after~     a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term,~     ranging from 50 to 70% in most studies. While effective rehabilitation, including regular~     exercise, is considered an effective tool of improving health related quality of life~     (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of~     different rehabilitation programs among HTx recipients is limited. Exercise training is~     considered one of the most central parts in rehabilitation, but the mode of exercise used in~     different studies varies considerably. It is documented that high intensity interval~     training (HIT) has superior effects compared to training with moderate intensity in cardiac~     and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had~     been considered unphysiological. However, the investigators have recently demonstrated~     highly beneficial effects on exercise capacity, muscle strength, body composition, reduced~     progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In~     the present study the investigators want to test the hypothesis that systematic aerobic~     exercise with high intensity improve exercise capacity also in newly transplanted~     recipients, and secondarily that it gives favourable effects on the heart, peripheral~     circulation and a better HRQoL.~   "
96319|NCT01796366|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338~     (insulin 338) in subjects with type 2 diabetes.~   "
96320|NCT01796353|"~     The objective is to investigate the effect of a comprehensive sexual rehabilitation program,~     consisting of a psycho-educative component and a physical exercise component.~      The primary hypothesis is that, a comprehensive sexual rehabilitation program improves~     sexual function.~   "
96321|NCT01796340|"~     The primary objective of the study is to investigate the effectiveness of two intensive~     two-session trainings, the conventional psycho-education and food cue exposure, on eating in~     the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese~     children.~   "
96322|NCT01796327|"~     This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that~     is taken up from the digestive tract into the body when given as an oral tablet compared~     with that taken up by an intravenous dose.~   "
96323|NCT01796314|"~     Therapeutic education expands in Alzheimer's Disease management in France. Several studies~     revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this~     study, is to determine whether a therapeutic educational programme for both AD patients and~     primary caregivers, in community dwelling, improves patient's quality of life.~   "
96325|NCT01796288|"~     This was a multi-center randomized controlled Phase II clinical trial. Patients with~     oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung~     cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits~     (free-from progression) were randomized (stratified according to smoking status and~     different research centers) to the radiotherapy group (n = 100) and the non-radiotherapy~     group (n = 100). Radiotherapy group (experimental group) patients started simultaneously~     radiotherapy for all gross tumors soon after randomization; non-radiotherapy group (control~     group) received no radiotherapy for all gross tumors. Erlotinib was continuously used until~     to disease progression or unbearable adverse effect, and the subsequently further salvage~     therapies were determined by the investigators. The primary endpoint was PFS.~   "
96326|NCT01796275|"~     The School of Public Health of HKU collaborates with the Hong Kong Council of Social Service~     (HKSCC) to conduct a district-based mega-project Happy Family Kitchen, which using~     eating and the kitchen as a platform, to make the effort to improve effective~     communication in Hong Kong families.~      The HFK 2 project is a enhanced version of HFK project, which plan to be conducted in the~     Tsuen Wan, Kwai Chung and Tsing Yi district from August 2012 to August 2013. This project~     adopts a cluster-randomized controlled design, with the application of positive psychology~     concepts as a theoretical framework. A community-based participatory (CBP) approach, which~     is an effective way to engage public health researchers and community members (NGOs,~     schools, other major stakeholders, and participants), will be used. Both quantitative and~     qualitative methods will be used in the evaluation of major outcomes (participants' family~     relationship and 3Hs) at different time points throughout the project. Process evaluation~     will be performed to evaluate the process of each component of the project. The whole~     project includes two phases:~      Phase 1: Model enhancement- an enhanced model of project is started with the training the~     trainer workshop to build capacity among the community partners. After that, the trained~     community partners design and conduct the district-based intervention programmes by using~     one of the five themes of the positive psychology framework, which teach the participants to~     practice positive behaviors for improving family communication, and in turn promote the 3Hs.~     The five themes are joy, flow, gratitude, savoring and listening. The pre-, post-, 4 weeks~     and 3 month follow up questionnaire surveys are conducted to assess the effectiveness of the~     programmes. All of the participating NGOs and schools will be randomly allocated into three~     groups:~      Intervention arm 1: core session intervention + booster intervention; Intervention arm 2:~     only core session intervention; Control arm: waiting list control, only questionnaire~     evaluations can be conducted at different time points.~      A subsequent qualitative study is conducted to further explore the outcomes, the problems~     and the requirements from the programmes.~      Phase 2: Model scaling up- A series of Professional Tool Kits consist of practice guides and~     evaluation tools for different service settings will be published with the contribution of~     participating NGOs and project partners. The tool kits will be the key reference and be~     further disseminated to a wider scope. A series of Professional Practice Seminars will be~     organized in different regions (including Hong Kong, Kowloon and New Territories). Social~     work practitioners of various service settings will be invited to attend the seminars. The~     evidence-based professional tool kits will be introduced and distributed in the seminar.~     Clinical psychologist will be the speaker on how to apply positive psychology in practice,~     and HKU staff will also illustrate the use of evaluation tools in assessing the outcome of~     the program. Participating NGOs of this project will be invited to share their practice~     experience in Tsuen Wan and Kwai Tsing district as well. another new edition of Happy Family~     Cookbook will be published and distributed to the whole territory. The new edition will be~     enhanced with more attractive content including healthy recipes and tips for positive~     communication etc. To enhance the interactivity of the cookbook, related apps for mobile~     devices will be developed for public free download.~   "
96327|NCT01796262|"~     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in~     reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample~     of children and adolescents with ADHD.~   "
96328|NCT01796249|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI)~     measured at the end of surgery for the prediction of immediate postoperative pain in~     postoperative care unit in adult patients undergoing general anesthesia.~   "
96329|NCT01796236|"~     To demonstrate that the minimally invasive surgical procedure in combination with the use of~     the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection,~     overgrowth, pain and numbness at the site of implantation compared to the traditional~     surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha~     BA300 Abutment).~      To demonstrate that the minimally invasive surgical procedure in combination with the use of~     the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due~     to shorter surgical procedures, faster wound healing and less complications compared to the~     traditional surgical procedure in combination with the use of the standard Baha abutment~     (Cochlear Baha BA300 Abutment).~   "
96330|NCT01796223|"~     The aim of this study is to evaluate the effects of a feedback-system in psychotherapy on~     adult out-patients at a community mental health centre. It is hypothesized that the~     intervention will lead to more effective treatment, decreasing treatment dropout as well as~     improving patient-therapist relationship and patient activation in treatment.~   "
96331|NCT01796210|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the~     prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on~     general anesthesia.~   "
96332|NCT01796197|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer. In~     this study, paclitaxel and trastuzumab are being combined with pertuzumab which is~     investigational for the preoperative treatment of inflammatory breast cancer. Trastuzumab~     is given for a total of 12 months for the treatment of HER2 positive breast cancer. This~     study also adds pertuzumab to trastuzumab so that both drugs are given for a total of 12~     months; this combination is also investigational.~      Investigational means that pertuzumab is being studied. It also means that although the~     FDA has approved pertuzumab for preoperative use to treat breast cancer, it has not been~     thoroughly studied in combination with paclitaxel and trastuzumab for preoperative treatment~     of inflammatory breast cancer. It has been FDA approved for specific use in advanced breast~     cancer that is HER2 positive.~      Pertuzumab is an antibody, which is a protein that attacks a foreign substance is the body.~     Pertuzumab blocks the function of the HER2 protein like trastuzumab does. However,~     pertuzumab binds to a different part of the HER2 receptor and stops cancer cells from~     growing. This drug has been used in the treatment of advanced breast cancer that is HER2~     positive, and has been combined with trastuzumab and chemotherapy in those studies.~     Information from those other research studies suggests that pertuzumab may help to kill the~     cancer cells in the breast and enable you to undergo a mastectomy. The addition of~     pertuzumab may also help reduce the chance of cancer recurrence.~      In this research study, we are combining pertuzumab with paclitaxel and trastuzumab as~     preoperative therapy and will determine the response of the cancer remaining in the breast~     at the time of mastectomy. In addition, we are combining trastuzumab with pertuzumab for a~     total of 12 months and we are looking to see whether the combination reduces the chance that~     the cancer will return.~      Another goal of this research study is to determine whether we can develop a way to identify~     tumors that will respond well to this study treatment. We will do research tests on your~     tumor tissue before, during and after study treatment. These tests may help doctors~     understand how the study treatment may work to treat your type of breast cancer. In the~     future, these tests may help us find ways to help match patients with the drugs most likely~     to work against their specific tumors before treatment begins.~   "
96333|NCT01796184|"~     Background. Obesity, insulin resistance and type 2 diabetes are closely associated with~     chronic inflammation characterized by abnormal cytokine production. Some authors have found~     discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control,~     suggesting that a glycation gap, defined as the difference between the HbA1c concentration~     and that predicted by the fructosamine concentration, could explain the excess~     interindividual variation in HbA1c.~      The present study was aimed to examine the association between inflammation,~     sociodemographic (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco~     consumption), and common diseases. In addition, we also examine levels of blood glucose,~     HbA1c, fructosamine and glycation gap determining the prevalence of high glycators in a~     general adult population and their association with lifestyles and prevalent diseases.~      Methods. Selection of a random sample of the general adult population from a single~     municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling~     includes 3,500 subjects. Considering approximate 67% participation rate, the final study~     population would include more than 2,000 individuals. The standard workup includes~     structured questionnaires, skin prick test, periodontal examination, psychological tests,~     physical examination and blood determinations to allow for categorization of participants in~     terms of basic demographics, profession, education level, socioeconomic level, quality of~     life, physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes,~     metabolic syndrome, hypertension, cardiovascular disease, and liver disease. We determine~     blood levels of inflammation markers, HBA1c, fructosamine and glucose. We will collect a~     urine sample for microalbuminuria determination. In addition, blood will be drawn to be~     stored at the Biobank of our Hospital. One half of participants (~1000 individuals) will~     undergo continuous glucose monitoring. The design is cross-sectional, followed by a~     longitudinal study using population registries for the determination of events (mortality).~      Discussion. This comprehensive study in a general adult population provides an excellent~     opportunity to determine serum concentrations of inflammation and glycation markers and how~     they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic~     diseases. The findings from this study should also help to find out the relationship between~     glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation~     markers.~      Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose~     monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.~   "
96334|NCT01796171|"~     This study is a phase I/II, open-label study in patients with relapsed positive non-Hodgkin~     lymphoma. The Phase I part of the study is a dose escalating study to define the maximum~     tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics,~     biodistribution and efficacy. After completion of the phase I study, a dose will be selected~     for the phase II part of the study which is designed to investigate tumour response rate,~     progression free survival, confirmation of the selected dose as well as safety and toxicity.~   "
96335|NCT01796158|"~     The goal of this project is to conduct a pilot study evaluating feasibility, acceptability,~     and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET)~     intervention for alcohol-involved adolescent primary care patients.~   "
96336|NCT01796145|"~     In patients with inoperable HCC undergoing non-surgical therapy as first-line therapy~        1. We aim to determine the prognostic significance of liver stiffness in patients with HCC~        2. We aim to determine the rate and severity of complications of treatment and its~          association with liver stiffness in patients with HCC~   "
96337|NCT01796132|"~     Background: The childbearing years are a time of increased vulnerability to the onset of~     mood disorders in women and a high prevalence of exposure to antidepressant drugs during~     pregnancy and postpartum has been reported. However, the lack of information regarding the~     milk transfer and the safety of these drugs in breastfed infants and the related fear of~     adverse events for the sucking infant are some of the factors responsible for stopping~     prematurely breast-feeding or avoiding drug therapy. Selective serotonin reuptake inhibitors~     (SSRI) and selective serotonin and noradrenaline reuptake inhibitors (SNRI) are the most~     frequently prescribed antidepressant drugs during pregnancy and the post-partum period. They~     exhibit a wide interpatient variability in their concentration profiles that has been~     related to numerous environmental, stereochemical, demographic and genetic influences that~     might alter the level of exposure of breastfed newborns. Limited information is available~     regarding the safety of use of these antidepressant drugs during lactation, and is generally~     derived from small studies. A comprehensive description of their distribution and~     quantification in milk in a larger cohort of patients under various influences and the~     resulting impact on milk concentrations is lacking.~      Objectives: The current proposal addresses the primary objectives of quantifying the range~     of concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine,~     fluvoxamine, duloxetine and venlafaxine in mother plasma and breast milk in relation to~     genetic polymorphisms, stereochemistry, demographics and environmental factors in a large~     cohort of depressive mothers. This will enable to derive the exposure to the breast-fed~     child taking into account this variability and therefore better adjust treatment to~     potential influences. As secondary objectives, we will examine the neurodevelopmental~     outcome of a sub-set of infants subjected to SSRI/SNRI in utero and/or during breastfeeding~     at birth, 6, 18 and 36 months, and compared to that of a control population of infants not~     subjected to this treatment.~      Expected Results: The proposed strategy will offer new information regarding the expected~     level of drug exposure associated with each or with a combination of risk factors and help~     for optimizing the security and rationalizing the use of antidepressant treatment in~     lactating women. Hence, research on the safety of use of these drugs for the developing~     child is an area of great public health significance.~   "
96338|NCT01796119|"~     In this split-mouth controlled study, implants placed using the alveolar ridge expansion~     technique will be compared to those placed in native bone with sufficient horizontal bone~     width.~      The Piezosurgery device and Bone expanders (Mectron,Italy) will be employed in an alveolar~     ridge expansion technique.~   "
96339|NCT01796106|"~     The goal of the project is to investigate the clinical efficacy of management of early~     caries lesions by resin infiltration, which may be imaged through a SFE laser optical device~     comparable to radiographic results.~   "
96340|NCT01796093|"~     This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.~      The authors have no conflict of interest and there was no financial sponsoring The study was~     planned according to the Good Clinical Quality standards using an intention-to-treat~     analysis. The protocol was approved from the ethics committee. Selected patients gave their~     written informed consent. The family practitioners agreed and obtained the collected data~     and analysis. Analysis of collected data was performed by a single-blinded author (without~     knowledge of the used test drug and time of collection of data).~      Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with~     permanent atrial fibrillation (ischemic etiology).~      Multiple Time Frames: Primary Outcome is measured before and after each medical~     intervention.~      Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):~      Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and~     during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection~     rate, left trial size,diastolic function.~      Participants were followed (ambulatory observation) for at least 3 months~   "
96341|NCT01796080|"~     In this randomised controlled cross-over study we will investigate whether intrathoracic~     pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature~     supraventricular and ventricular contractions as well as atrial fibrillation in patients~     with paroxysmal atrial fibrillation.~   "
96342|NCT01796067|"~     The increasing rate of obesity has become a major public health concern with national~     reports indicating 40% of African American adolescents are now overweight/obese. Little is~     known about effective weight loss interventions in ethnic minority adolescents. However,~     research has shown that ethnic minorities attend fewer intervention sessions, have higher~     attrition rates and lose less weight compared to Caucasians. Two fundamental problems~     related to this lack of progress are 1) lack of appropriate content of weight loss~     interventions for African American adolescents that integrate cultural issues, parenting~     skills, and motivational strategies for long-term change and, 2) poor dose of weight loss~     interventions because of participant fatigue and drop out. While previous weight loss~     studies for adolescents have been long lasting (12-25 weeks), our team developed a weight~     loss program that is a relatively brief (8-week) face-to-face intervention that integrates~     motivational (autonomy-support) and positive parenting skills (monitoring, social support,~     positive communication skills) for reducing z-BMI in overweight African American~     adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week~     on-line culturally tailored intervention, Thus, the goal of this project is to conduct a~     randomized controlled efficacy trial to address the problems with past studies by 1) making~     the face-to-face group intervention shorter, 2) using an on-line component to compliment the~     group-based intervention for increasing dose, and by 3) tailoring a motivational and~     parenting skills program directly to parents and adolescents skill levels and cultural~     background. 520 overweight African American adolescents and their parents will be recruited~     to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group~     randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic~     health (BH) education program on reducing z-BMI and improving diet and physical activity~     (PA) in overweight African American adolescents. In phase II of the trial participants will~     be re-randomized to either an 8-week on-line intervention or a control on-line program~     resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program)~     factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL~     group plus 8-week on-line intervention program will show the greatest maintenance in~     reducing z-BMI.~   "
96343|NCT01796054|"~     Mindful meditation sessions have been associated with an improvement in mindfulness,~     perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation~     has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen~     consumption and energy expenditure. Randomized controlled trials of online mindfulness and~     relaxation programs have been studied in patients with conditions such as irritable bowel~     syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such~     programs given levels of job stress. This study will determine whether an online stress~     reduction program that incorporates meditation with and without concomitant group support~     reduces burnout among nurses, including emotional exhaustion and depersonalization. The~     proposed research study will utilize Stress Free Now, an online stress reduction program~     developed by Cleveland Clinic Wellness Institute.~   "
96344|NCT01796041|"~     According to the World Health Organization, breast cancer is the most common cancer in~     women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly~     420,000 women perished from the disease in 2002. Surgery remains the best option for~     patients presenting with operable Stage I, II or III cancers. Breast conservation surgery~     has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable~     breast cancer are breast conservation candidates. However, the need to achieve negative~     tumor margins often requires a second operation (re-excision) in up to 70% of the women~     having lumpectomy surgery. Currently, tumor margins assessment in the operating room is~     often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed~     intraoperative imaging technique may provide the surgeon with an alternative, and hopefully,~     more sensitive method to assess tumor margins which may decrease re-excision and the~     morbidity associated with additional surgery, and, perhaps, lower the risk of local regional~     recurrence.~   "
96345|NCT01796028|"~     Prostate cancer is the second leading cause of mortality in men, representing 10 deaths~     about of 100 cancers (INVS 2009). Treatment for metastatic prostate cancer, when becoming~     resistant to hormone-treatment, is mostly resumed to a relatively ineffective chemotherapy~     (Docetaxel/TAXOTERE®) (1). Recently, numerous clinical and preclinical works showed that~     Metformin could represent an excellent candidate for treatment of advanced prostate cancer.~     This is a widely prescribed drug, for type 2 diabetes, with clinical advantage of exhibiting~     very rare serious side effects. On the other hand, the use of this molecule in patients was~     associated with a decrease of tumors incidence, in particular prostate cancer (2). Numerous~     in vitro and in vivo studies support its role as an anti-cancer drug, in several cell lines~     (3). These experimental results are consistent with a clinical trial pilot study, performed~     in colorectal cancer, showing anti proliferative effect of Metformin (4). In the field of~     prostate, F. Bost in J.F. Tanti's team (INSERM U895, Nice) demonstrated that Metformin~     inhibits cell viability of human prostate cancer cells, via mTOR downregulation and decrease~     tumor growth in a xenograft model (5). Furthermore, preclinical data performed by this team~     showed that Metformin increased significantly apoptosis induced by TAXOTERE®. Therefore, by~     targeting specifically cancer cell metabolism, Metformin offers new promising therapeutic~     strategy.~      The primary objective of this randomized study is to evaluate the biological efficacy of~     Metformin combination with TAXOTERE® in patients with metastatic hormone-refractory prostate~     cancer. To achieve this purpose, PSA response rate will be evaluated according to ASTRO~     definitions (Bubley, Carducci et al. 1999). Concurrently, secondary endpoints will be under~     investigation in order to evaluate the clinical response according to RECIST criteria, the~     overall and free-progression survival and the quality of life. Toxicity assessment will also~     be performed regarding to this drug combination.~      Considering the well tolerability of Metformin and the first clinical and pre-clinical data~     reports of it use in cancer treatment, combining Docetaxel (TAXOTERE®) with Metformin may~     represent a promising strategy for treatment of hormone-refractory prostate cancer.~   "
96346|NCT01796015|"~     Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury~     (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also~     a risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP)~     monitoring is likely to guide therapeutics, and certain research on adults or on children,~     suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve~     the prognosis. Two monitoring techniques are currently recommended. They are reference~     methods for ICP measure :~        -  monitoring with intraventricular catheter,~        -  intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have~          been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD)~          which is the most interesting one. The ONSD measured ultrasonically is correlated with~          ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the~          first 24 hours. In children, ONSD average values have been worked out, and an ONSD~          increase is found in children suffering from hydrocephalus with IH and in children with~          TBI. ICH precocious detection is fundamental in children sensitive to ICH because their~          cerebral development is not finished yet. Difficulties met for ICP monitoring~          implementation in infants and its invasive nature are often disliked by clinicians. A~          non-invasive exam is then essential to allow a better care of children with ICH in~          intensive care unit.~   "
96347|NCT01796002|"~     Primary objective of the study is to compare the efficacy of romidepsin when administered~     with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma~     (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria~     for malignant lymphoma 1999 by RAC.~   "
96348|NCT01795989|"~     The purpose of this research study is to test the use of new Magnetic Resonance Imaging~     (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil~     is the part of the MRI system that collects data to make the MR images. The investigators~     have designed, developed, and built two child-sized coils to use when imaging elbows,~     wrists, knees, and ankles. These new coils will be better suited to fit infants through~     teenagers rather than the conventional coils used which were created for adults These MRI~     coils have not been approved by the US Food and Drug Administration (FDA) and are considered~     investigational devices.~   "
96349|NCT01795976|"~     This is a trial of adoptive T cell therapy using the patient's own T cells, genetically~     engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous~     cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white~     blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the~     laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide~     (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The~     NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to~     14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4.~      The primary objective of response rate according to Response Evaluation Criteria in Solid~     Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12~     and at 12 weekly intervals thereafter.~   "
96350|NCT01795963|"~     The purpose of the present study is to examine the impact of ePREP when it is administered~     to couples. More specifically, investigators will test whether--compared to placebo~     controls--participants who receive ePREP will experience better outcomes for relationship~     relevant variables.~   "
96351|NCT01795950|"~     The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary~     arterial hypertension (PAH). PLX-PAD is a cell-based product made of allogeneic~     Mesenchymal-like Adherent Stromal Cells (ASCs), derived from human full-term placentas~     following an elective caesarean section. This year-long study will evaluate the safety of~     three different dose levels of PLX-PAD, each given as a single intravenous infusion. This~     study will also evaluate effects that PLX-PAD may have on PAH, such as changes in the~     ability to exercise and on other tests used to measure the disease severity.~   "
96352|NCT01795937|"~     To investigate the effect of steady-state itraconazole on the pharmacokinetics of~     steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose~     pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the~     single-dose pharmacokinetics of rosuvastatin~   "
96353|NCT01795924|"~     The purpose of this study is to determine whether PD-616 in combination with low-dose~     Cytarabine is safe and effective in the treatment of untreated or relapsed/refractory acute~     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).~   "
96354|NCT01795911|"~     Substudy C: The purpose of this substudy is to determine whether Lambda combined with~     Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with~     genotype 1b chronic HCV infection~   "
96355|NCT01795898|"~     The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino~     participants with osteoarthritis (disorder which is seen mostly in older persons in which~     the joints become painful and stiff) and chronic (lasting a long time) low back pain.~   "
96356|NCT01795885|"~     The purpose of this study is to determine whether watching the MTV (Music Television)~     television show 16 and Pregnant could affect teen girls' attitudes about teen pregnancy,~     teen parenting, and pregnancy prevention. The investigators will recruit teen girls, ages~     15-18, who will be randomized to the intervention group (who will be asked watch 4 episodes~     of the show over a 4 week period) or the control group (who will not be intentionally~     exposed to watching the show, and will not be told which show the intervention group is~     watching). The investigators will evaluate, through survey, their attitudes about teen~     pregnancy and teen parenting before and after the intervention period, and compare the two~     groups at the conclusion of the study.~      The investigators' hypothesis is that the teens that are exposed to watching the show will~     have less favorable attitudes towards teen pregnancy and teen parenting than those teens who~     are not exposed to watching the show.~   "
96357|NCT01795872|"~     This study assesses clinical and imaging long-term data, after early or delayed~     interferon-beta-1b treatment in patients with a first demyelinating event suggestive of~     multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly~     Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main~     objectives are to describe the disease course, change in disability, cognitive function,~     resource use and employment status, in relation to Interferon beta-1b in the long term.~   "
96358|NCT01795859|"~     The purpose of this study is to determine whether SD-809 ER tablets are effective in the~     treatment of chorea associated with Huntington's Disease.~   "
96359|NCT01795846|"~     The incidence of allergic rhinitis and asthma is increasing in throughout the world as well~     as our country. Allergen-specific immunotherapy has been in use for almost 100 years. Since~     then, it is recommended for the management of Immunoglobulin E (IgE)-mediated allergic~     diseases as the only immune modulator therapeutic tool. It is well documented that allergen~     immunotherapy performed using single allergen is efficacious in monosensitized patients.~     Hence, polysensitization is much more prevalent than monosensitization in patients with~     respiratory allergy. On the other hand, polysensitization may have a paramount relevance in~     clinical practice; for example, many allergists have doubts in choosing the allergen extract~     for allergen specific immunotherapy. In this regard, the evaluation of immunotherapy~     efficacy in polysensitized patients still represents an unanswered question and there are~     very few studies on this issue. However, most clinical trials of allergen immunotherapy have~     been performed with multiple different allergen extracts using sublingual route. To the best~     of our knowledge, no common single-allergen (house dust mite Dermatophagoides pteronyssinus,~     Der p) subcutaneous immunotherapy trials have been specifically designed to compare efficacy~     in monosensitized and polysensitized patients. Furthermore, few studies have demonstrated~     that monosensitized and polysensitized patients appear to differ in terms of their immune~     reactivity. But, it is unknown whether single-allergen immunotherapy protocol elicit~     distinct immune responses in monosensitized and polysensitized patients.~      The aim of this study was to investigate the immunological changes and clinical~     effectiveness of most relevant single-allergen immunotherapy in patients with allergic~     rhinitis and/or asthma. The study population will included 40 adult patients with~     moderate/severe perennial allergic rhinitis and mild/moderate asthma who were monosensitized~     to house dust mites or sensitized to at least 2 different allergens including house dust~     mites. No patient will previously had been performed allergen immunotherapy. The study plan~     is prospective, randomized, double-blind, placebo-controlled. Both groups will first~     received placebo injections for 3 months, and followed by a cluster immunotherapy schedule.~     After the maintenance dose will be reached within 6 weeks, injections will be received at~     monthly intervals. Standardized depot preparations of Der p extract (Alutard Standard~     Quality SQ, ALK-Abello (Company Name), Madrid, Spain ) were administered by means of~     subcutaneous injection. All eligible patients will underwent 8 weeks run-in period to~     evaluate their baseline clinical status based on history of allergy, symptom and medication~     usage for rhinitis and asthma, skin prick testing, pulmonary function tests and methacholine~     bronchoprovocation tests. According to the sensitizations, patients will be divided to 2~     parallel groups either as polysensitized or monosensitized. Afterwards, both patient groups~     will be followed by symptom and medication scales, visual analog scores, quality-of-life~     scores for 1 month before placebo and immunotherapy. During this period, total serum IgE,~     specific IgE levels will be measured using the method of UNI-CAP 100 (Phadia, Uppsala,~     Sweden) and repeated after placebo and immunotherapy injections. At baseline, after placebo~     (3 months) and immunotherapy injections (at third months of maintenance period), nasal~     allergen provocation test with Der p extract will applied to the study groups. Peripheral~     whole blood will drawn for the analysis of basophil activation marker CD203c (CD, cell~     differentiation) expression at this three time points. For the clinical assessment, all~     patients will record on diary cards their symptom scores, visual analog scale scores,~     medication usage, quality-of-life measures for rhinitis and asthma. On each clinical visit,~     physical examination and side effects will be collected from diary card data. In conclusion,~     we believe that this study may be help for more understanding of the immune response to~     allergen specific immunotherapy at early stage. On the other hand, if the similar clinical~     improvement is demonstrated between the two groups with common single-allergen (Der p)~     immunotherapy, unnecessary usage of multiple allergens may be prevented as well as~     therapeutic side affects and cost.~   "
96360|NCT01795833|"~     Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent~     clinical trials have demonstrated that it may be prevented by lifestyle intervention focused~     on diet and physical activity. These trials have been expensive and labour intensive and~     this has limited translation of the known benefits to the population at large.~      We propose using a mobile phone intervention for lifestyle change and will assess it in a~     clinical trial(study) in people with impaired glucose regulation (high risk at developing~     type 2 diabetes).~      The study will be conducted in both India and the UK. The purpose of the study is to assess~     the effectiveness and acceptability of a text messaging system to prevent the progression to~     diabetes in people with high risk. The study involves five visits to clinic over 2 year~     period.~      Study participants will be divided into two groups by the computer generated random method -~     one is 'Usual Care' group and the other 'Text Messaging' group.~        -  Usual care will consist of a 30 minute interview, delivering personalized diet and~          exercise advice, supplemented by written material and education regarding diabetes.~          This will be delivered once at the beginning of the study.~        -  The intervention group will undergo the same initial interview and, in addition, will~          receive 3 times weekly text messaging with education, advice, support and motivation.~          These messages will be personalized to individual targets set at the initial interview.~      The primary outcome will be progression to diabetes, with and without SMS intervention.~     Secondary outcomes will be improvements in physical activity (reported and directly~     measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL~     cholesterol and serum triglycerides).~   "
96361|NCT01795820|"~     Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients~     presenting with acute coronary syndrome. Such therapy is started with the administration of~     a loading dose in patients which are not yet under treatment with P2Y12 inhibitors~     (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a~     satisfactory inhibition of platelet aggregation in patients who are already treated with a~     previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound~     ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet~     aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with~     or without a loading starting dose of the newer drug.~   "
96362|NCT01795794|"~     Congenital Dyserythropoietic Anemia Type I (CDAI) is a recessive autosomal disease caused by~     ineffective erythropoiesis that causes Anemia & accumulation of iron due to increased~     absorption of iron in the intestine.~      The iron is being accumulated in the body & causes damage of the liver, heart & endocrine~     glands.~      The standard follow up of iron levels is done by ferritin blood test & although the test is~     not accurate it is the most available.~      Medical treatment to removal of iron excess from the body is given in ferritin levels of~     500-1000.~      3 drugs are approved in the market:~        -  Deferoxamine, given subcutaneous during the night, 5-7 nights/week and therefore is~          less used today.~        -  Deferiprone-given 3 times a day, is a weaker chelator, although it seems like it is~          good to give it in combination with one of the 2 other drugs because it removes the~          iron from the heart's cells better.~      A rare but severe adverse effect is Agranulocytosis. This drug is usually not given in~     childbirths.~      -The 3rd drug which is mostly in use today is Deferasirox, given once daily, but has also~     adverse effects, among them- damage of liver & kidney function, damage to the digestive~     system, hearing and seeing.~      Iron is being absorbed in acidic area, & thus drugs which decrease the acidity like hydrogen~     pump's inhibitors, can inhibit the absorption of iron, and indeed there are reports that~     these drugs decrease the absorption of iron and were used as treatment to hemochromatosis as~     well.~      Those hydrogen pump's inhibitors have also adverse effects. The rarest but most severe is~     intestine infection by Clostridium.~      In children, reports of adverse effects are minimal- mostly headaches & abdominal pains and~     nosocomial infections. In adults, there are reports of fractures, magnesium deficiency &~     vitamin B12 deficiency. All in all, the adverse effects are rare & uncommon.~   "
96363|NCT01795781|"~     New anticoagulants are being introduced to replace warfarin. These drugs do not require~     monitoring and are safer. There is currently no recommended way to reverse these drugs~     rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to~     look at ways to reverse the drugs rapidly~   "
96364|NCT01795768|"~     To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2~     amplified breast, squamous lung and stomach cancer whose cancers have progressed following~     previous chemotherapy~   "
96365|NCT01795755|"~     The objective of the study is to assess the impact of horse assisted therapy (HAT) on:~        -  Addiction treatment outcomes (its effectiveness as an alternative therapy)~        -  Addiction treatment dropout & addiction relapse (its efficacy in preventing dropout).~      Hypothesis: HAT will correlate with:~        -  beneficial treatment outcomes of depression, anxiety, aggression~        -  with improved self esteem & motivation~        -  lower treatment dropout & addiction relapse.~   "
96366|NCT01795742|"~     This is an equivalence study comparing an electric nebulizer with a human-powered~     nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma~     exacerbations in a regional clinic in San Salvador, El Salvador.~   "
96367|NCT01795729|"~     The aim of the study is to compare optimal medical therapy alone versus percutaneous~     coronary intervention on top of medical therapy in the setting of heart transplant recipient~     coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the~     composite of death, myocardial infarction, need for transitory or permanent ventricular~     assist device implantation, myocardial revascularization, occurrence or worsening of heart~     failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at~     least 25% compared to baseline. The hypothesis of the study is the superiority of the~     interventional management over medical therapy alone in preventing the occurrence of the~     primary endpoint of the study.~   "
96368|NCT01795716|"~     1. purpose: To conduct the relative bioavailability study of a single dose and multiple~          doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus~          Glivec (Novartis Pharma Stein AG).~        2. Experimental Design： Two-period crossover design~        3. Test drug: imatinib mesylate capsule Reference drug: Glivec~        4. Sample size：20~   "
96369|NCT01795703|"~     The purpose of this study is to investigate the safety and efficacy of abiraterone in~     participants with metastatic castration-resistant prostate cancer (mCRPC) who have received~     docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).~   "
96370|NCT01795690|"~     The purpose of this registry is to record information of routine treatment of anemia in~     cancer patients in Germany. An overview of the current treatment of anemia in German~     outpatient centers and hospitals will be provided. Primary outcome parameters, e.g.~     improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of~     different treatments will be analyzed.~   "
96371|NCT01795677|"~     JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT)~     in patients with primary or secondary myelofibrosis : a prospective phase II~   "
96372|NCT01795664|"~     This study will be conducted as a randomized, double blind, double dummy two period~     crossover study in stable asthma patients. A total of 16 stable asthma patients treated in~     accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.~      Objectives:~        -  The primary objective of this study is to evaluate the effect of both the study drugs~          under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate~          the particle deposition in the lungs using Computational Fluid Dynamic (CFD)~        -  The secondary objectives are to assess the effect of both the study drugs on lung~          function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking~          Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog~          Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will~          be evaluated through monitoring of adverse events (AEs) throughout the study.~   "
96373|NCT01795651|"~     Medical education involves the acquisition of a large quantity of information. Lecture-based~     learning (LBL) is the best known of conventional teaching methods. Two thirds of critical~     care junior doctors identified at best only one of the three main take-home messages of a~     lecture, suggesting that knowledge transfer is poor during passive format learning.~      The investigators assess the impact of an intervention including the identification of~     take-home message of lecture with slides calling Learning Objectives, Message,~     Conclusion, in the identification of take-home message in critical care junior doctors.~   "
96374|NCT01795638|"~     Adequate growth during the neonatal period is critical for optimal long term outcomes.~     Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to~     thrive suggesting that factors other than total calorie intake are important in ensuring~     consistent weight gain. Several reports have indicated a positive sodium balance is critical~     in ensuring good weight gain in very low birth weight infants, however these infants are~     susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to~     diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but~     there is no evidence for this practice in preterm neonates. Our central hypothesis is that~     early supplementation with sodium will ensure positive sodium balance in very low birth~     weight infants and will result in optimal weight gain and enhanced long term outcomes.~     Secondarily we hypothesize that low sodium concentrations in the urine will not correlate~     with low serum sodium values.~   "
96375|NCT01795625|"~     The evaluation will determine professional clinical accuracy comparing the OneTouch®~     Verio™Pro+ blood glucose results with the YSI 2300 analyzer. Professional Clinical~     Accuracy is defined as accuracy of the system when used by a trained healthcare~     professional.~   "
96376|NCT01795612|"~     Physical exercise has been identified as a major item of many chronic diseases and cancer~     rehabilitation. It contributes to an improvement in the quality of life and to a decrease in~     the current treatment side effects and mortality. Cancer in association with treatment~     toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems~     in daily activities. The physical capacity and the tolerance for exercise fall~     simultaneously leading to a deconditioning vicious circle which increases physical,~     psychological and emotional symptoms of fatigue. Therefore, physical activity for health is~     a valid and relevant way to improve quality of life and to manage cancer patient fatigue.~     The aim of the study is the assessment of the effects of a physical activity retraining~     program on aerobic capacity, strength and fatigue, in a breast cancer population treated by~     adjuvant or néoadjuvant chemotherapy.~   "
96397|NCT01795339|"~     This is a two-part multiple dose study in healthy male and female (of non-child bearing~     potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety,~     effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being~     developed for the treatment of Alzheimer's Disease~   "
96398|NCT01795326|"~     A physician survey to document receipt of metabolic educational materials and assess~     behavior of physicians in following messages communicated through the educational materials~   "
96399|NCT01795313|"~     The purpose of this study is to see if vaccination with HLA-A2 restricted peptides, combined~     with the immunoadjuvant imiquimod is safe and can induce immune responses in children with~     recurrent ependymomas. Eligible patients are stratiﬁed by primary tumor location.~   "
97526|NCT01780506|"~     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)~     FDC in HIV-1 positive, antiretroviral treatment-naive adults.~   "
96377|NCT01795599|"~     More than 100 000 surgical abortions are annually performed in France. About four in ten~     women will have an abortion in their life. Abortion complications are cervical tearing~     (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%).~     These complications can first compromise the vital prognosis and are involved in 10% of the~     worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard~     to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding),~     and are finally responsible for obstetrical pathologies as late miscarriages or premature~     delivery due to cervical insufficiency. All that complications are linked to cervical~     laceration of the surgical abortion, that can be reduced by the recommended use of~     mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks.~     However, it does not exist data evaluating the superiority of one of the two molecules or~     their combination. These data could optimize the cervical preparation and thus reduce the~     abortion complications with a direct impact on maternal mortality, infertility and~     obstetrical complications. Thus, it seems to be important to evaluate these two molecules~     and their combination.~      Objectives To compare mifepristone, misoprostol and their combination in the cervical~     preparation of the surgical abortion between 12 and14 weeks for their efficacy,~     complications and side-effects.~   "
96378|NCT01795586|"~     This study is being done to see how safe the combination of eribulin and carboplatin is and~     if it will work to help people with advanced breast cancer. Eribulin and carboplatin are~     both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells~     which control every function in the body. Some cells stop working like they should and~     become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction~     to normal body organs. Eribulin and carboplatin have both been approved by United States~     Food and Drug Administration (FDA) for use in the treatment of breast cancer. The~     combination of these two drugs and the safest dose of eribulin to use is experimental.~   "
96379|NCT01795573|"~     Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute~     graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling~     transplants.~   "
96380|NCT01795560|"~     Follow up via ultrasonic abdoman after patients who were giagnosed and treated as~     periappendicular abcess and refused to be operated later on in the interval period . To~     ass what occured to their appendics ?~   "
96381|NCT01795547|"~     To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of~     patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical~     Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care~     setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.~   "
96382|NCT01795534|"~     The study will aim to describe and evaluate the effect of beetroot juice supplementation~     upon whole body running exercise at altitude. It is hypothesised that beetroot~     supplementation will decrease time to complete a 10 km time trial.~   "
96383|NCT01795521|"~     Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung~     cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year.~     Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five~     year survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed~     at advanced stages. However if lung cancer can be detected and treated at an earlier stage~     the outcome and survival is much more favorable with five year survival rates up to 77%.~      The current standard of care for small volume tumors is surgical resection in medically fit~     patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal~     lymph node sampling or lymphadenectomy. For the patient population with small volume disease~     at early stage surgery offers the potential of local tumor control in up to 96% of the~     patients.~      However, about one quarter of the patients is medically inoperable because of coexisting~     morbidities or poor general condition, mostly the result of a long smoking history and~     consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD).~      The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided~     stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally~     located NSCLC and in those who are not willing to undergo surgical treatment.~      Secondary objectives of the study are~        -  to assess safety of the treatment modality by collecting data about acute and late~          toxicity~        -  patterns of local and distant recurrence and relation between the site of local~          recurrence and the clinical (CTV) and planning target volume (PTV)~        -  survival and cause of death~   "
96384|NCT01795508|"~     The purpose of the study is to examine the effects of Parent Management Training Oregon~     (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing~     behavioral problems.~   "
96385|NCT01795495|"~     Significant pain may occur following posterior spinal fusion despite the use of~     conventionally accepted techniques including patient controlled analgesia. If detected, a~     significant reduction in opioid requirements may lead to improved patient satisfaction and~     decreased opiate side effects.~      The current study would use a prospective, randomized trial investigating the efficacy of~     one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia,~     along with a third control group. The patients would be randomized to receive remifentanil~     plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an~     infusion of magnesium; or remifentanil alone. In addition, the two medications being studied~     might make it easier to determine the efficacy of neurophysiologic monitoring including~     somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential~     (MEP) (mA) required to elicit the response.~      The purpose of this study would be to explore the effects of intraoperative methadone vs~     magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the~     efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of~     desflurane, remifentanil, and the need for intraoperative supplemental agents to control~     blood pressure.~   "
96386|NCT01795482|"~     The study should evaluate how long patients undergoing major abdominal surgery under~     combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent~     perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air~     skin-surface warming for different duration. Body temperature will be measured at the~     tympanic membrane. The investigators hypothesize that active warming before starting the~     epidural anaesthesia will decrease the incidence of perioperative hypothermia.~   "
96387|NCT01795469|"~     Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic~     intolerance in adolescents and adults. Compression stockings are commonly recommended as a~     treatment modality for POTS, but the effects of abdominal and lower extremity compression~     during tilt table testing have not been measured in adolescent patients. The aims of our~     study are to compare heart-rate changes and symptom onset during tilt table testing (a) with~     and without abdomen/lower extremity compression and (b) with abdominal compression only~     versus lower extremity compression only. During phase 1, 20 adolescents with POTS will~     undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10~     minutes with full compression (trial #2), and a third study without compression up to 10~     minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock~     garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to~     10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with~     abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and~     a third study repeated without compression up to 10 minutes (trial #3). To limit compression~     to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen)~     without straps 1-3 (lower extremities). For lower extremity-only compression, we will use~     Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will~     include mean and peak heart rates and timing of symptoms with each trial. A paired-samples~     t-test will be used to compare mean heart rates between trials for each study phase. Hazard~     analyses will be used to assess time-based endpoints.~   "
96388|NCT01795456|"~     The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound~     to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant~     Cell arteritis and to determine if patients with active arteritis have a thickening of their~     blood vessel walls compared to healthy people of the same age and gender.~   "
96389|NCT01795443|"~     The primary objective of this study is to compare the lumbar proprioception of patients with~     chronic back pain to that of healthy volunteers during low- and high-frequency muscle~     vibration.~      The order of measures (low frequency of vibration, high frequency vibration and no~     vibration) is randomized in a cross-over design.~      Patients and volunteers are matched by age and body mass index.~   "
96390|NCT01795430|"~     This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and~     high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk~     Ewing sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell~     or bone marrow transplant stops the growth of tumor cells by stopping them from dividing or~     killing them. After treatment, stem cells are collected from the patient's blood and stored.~     More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem~     cells are then returned to the patient to replace the blood-forming cells that were~     destroyed by the chemotherapy~   "
96391|NCT01795417|"~     To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in~     4 weekly applications to human periorbital skin area by grating pre- and 90-days post~     treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded~     evaluators.~   "
96392|NCT01795404|"~     A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates~     immediate psychosocial distress for the patient and his or her family. Distress is also~     experienced across the disease trajectory. Stress can manifest in a variety of psychological~     symptoms, such as anxiety and depression, intrusive cancer-related thoughts, or physical~     symptoms, such as fatigue, increased pain, and impaired sleep. Intensified stress in cancer~     patients has been associated with increased morbidity and mortality, decreased immune~     function, increased relapse, and decreased health-related quality of life. Given the known~     negative impact of stress on cancer patients, stress has become a priority issue in cancer~     treatment and research. Targeting stress-related variables with psychosocial interventions~     has been an important emphasis in cancer-care models. One of these care modalities is~     Inquiry-based stress reduction.~      The IBSR intervention, developed by Byron Katie, is a simple yet powerful process of inquiry~     that teaches the individual to identify and question the thoughts that cause him or her to~     experience stress and suffering. It is a way to understand what is hurting the individual,~     and to address the cause of his or her problems with clarity. This mindful-process, named~     The Work, facilitates that through four questions and a turnaround, which is a way of~     experiencing the opposite of what the individual believes in. The Work provides skills for~     self-inquiry and management of stressful thoughts which can be easily implemented in daily~     life. The study will focus on breast, colorectal and prostate cancer patients. These types~     of cancers have high incidence along with high survival rates.~      The primary objective is to examine the feasibility and effectiveness of IBSR for breast,~     colorectal and prostate cancer survivors on quality of life. We hypothesize that this~     intervention will lead to significant improvements in all quality of life domains (physical~     well-being, psychological well-being, social well-being etc.)~      Effects on secondary outcomes will be assessed, including depressive symptoms, anxiety and~     stress levels, and fear of recurrence. Physical symptoms (disturbance in sleeping patterns,~     fatigue, and pain), will be assessed as well. Biological measurements will be measured in~     blood samples in order to observe effects on neural and immune components.~      Additionally, we are interested in evaluating whether positive effects achieved from the~     IBSR program are modified by specific patient characteristics measured at baseline~     (optimism, social support, and spirituality).~   "
96393|NCT01795391|"~     Intravascular devices in intensive care units are often associated to complications. The~     investigators estimate that 23.5% of catheters placed and used in intensive care are subject~     to at least one complication; the goal is to demonstrate the effectiveness of the new~     Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications~     associated with intravascular catheters in intensive care.~   "
96394|NCT01795378|"~     The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells~     that are given after HLA-mismatched hematopoietic cell transplantation.~   "
96395|NCT01795365|"~     Active Surveillance manages selected men with prostate cancer expectantly with curative~     intent. This means men are carefully selected and subsequently actively observed in order to~     have the possibility to offer them curative treatment once the tumor seems to progress.~      The goal of this study is to validate the treatment option Active Surveillance in men with~     localized, well differentiated prostate cancer, in order to limit the amount of~     overtreatment. A number of key points will be studied, such as the pathological findings in~     radical prostatectomy specimens, and the effect of expectancy on the quality of life.~   "
96396|NCT01795352|"~     This is a national, multicentre, non-interventional, retrospective study to be carried out~     in the oncology settings of approximately 15-20 Spanish hospitals.~      At each participant hospital, all patients recently diagnosed with advanced EGFR mutated~     NSCLC (both newly or with recurrent disease , without previous treatment for metastatic~     disease) from April 2010 to December 2011 will be included as study population. Information~     about the follow-up of the patients during a minimum of 12 months after diagnosis will be~     collected.~   "
96449|NCT01794715|"~     Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a~     pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.~   "
96400|NCT01795300|"~     In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon~     radiotherapy in patients with skull base meningiomas. There will be two treatment arms with~     photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional~     fractionation. The study is designed as descriptive study on feasibility of the investigated~     therapies aiming at a comparison of toxicities. The study will serve as a basis for further~     larger randomized protocols comparing efficacy of the therapies, assuming toxicity is~     comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are~     overall survival, progression-free survival and quality of life.~   "
96401|NCT01795287|"~     There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft~     fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack~     of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during~     flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal~     pulses are late symptoms of ACS.~      Many experts think that effective relief of pain caused by regional anaesthesia (RA) may~     hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA~     is based on old patient-series and single case-reports. Some of these studies report the~     symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions~     in these studies cannot be confirmed by an expert of RA. It is also possible that there are~     more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS.~     There are no modern, randomized and controlled studies of the safety of RA in patients with~     tibial shaft fracture.~   "
96402|NCT01795274|"~     The physical and biological properties of the carbon ion beam promise to improve the~     therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose~     deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg~     peak can be directed into the defined target volume, and the sharp dose fall-off thereafter~     again spares normal tissue behind the target volume. The higher RBE of carbon ions, which~     has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely~     to contribute to an increase in local control, and perhaps in OS. Early data from Japanese~     centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate~     actively delivered carbon ion beams in patients with locally advanced pancreatic cancer~     within a dose-escalation strategy.~   "
96403|NCT01795261|"~     The purpose of this study is to determine if providing free laboratory test to pregnant~     women and their spouses at churches, in addition to laboratories or hospitals, will increase~     the number of pregnant women and their spouses who get screened for HIV, malaria, sickle~     cell trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep~     mothers healthy during pregnancy and lead to healthy babies. This research is taking place~     in 40 churches in Nigeria.~   "
96404|NCT01795248|"~     It is well-known that women with previous gestational diabetes mellitus are in risk of~     developing type 2 diabetes later in life; approximately half of the women develop overt type~     2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the~     effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous~     gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.~   "
96405|NCT01795235|"~     Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by~     which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to~     increase GH levels and to be stimulated by an increase in adrenergic activity. The proposed~     study will test the concept that with the fall in blood glucose it is likely that there is a~     sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads~     to the increase in GH and cortisol.~   "
96406|NCT01795222|"~     Evaluation of oral midazolam to improve children's behavior and reduces the stress and~     anxiety during dental treatment~   "
96407|NCT01795209|"~     The purpose of this study is to determine the effect of ranibizumab for the treatment of~     macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with~     initial fair visual acuity.~   "
96408|NCT01795196|"~     Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into~     account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using~     a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor~     and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can~     be kept and it can provide early indication of changes in respiratory status. IPI has only~     been studied in pediatric patients who are under sedation; however, more uses for the~     monitoring tool are a possibility. One of those possibilities is to use IPI to monitor~     pediatric patients during the weaning and extubation process to determine if a specific~     number, or less than a specific number, is associated with extubation failure. Therefore,~     clinicians and physicians would be better able to determine if the patient is ready for~     extubation.~   "
96409|NCT01795183|"~     Primary Objective:~      To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia~      Secondary Objective:~      To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.~   "
96410|NCT01795170|"~     Restricting dietary lysine intake in infants from age 3 months or less with confirmed~     diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce~     the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent~     1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years~     of age by acting as an effective intervention into the complex pathophysiology of the~     condition.~   "
96411|NCT01795157|"~     This study aims to investigate computer based symptom assessment in an outpatient cancer~     population, and the use of a computer based decision support system to facilitate the~     diagnosis and treatment of cancer related pain.~      Primary hypothesis is, that this approach improves pain control and pain management in an~     unselected group of cancer patients in an outpatient setting.~        -  Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale~        -  Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale~        -  An alteration in the prescribing dose of opioids in equipotent opioid dosage~      Secondary hypothesis is, that this system improves overall symptom control and symptom~     management in an unselected group of cancer patients in an outpatient setting.~   "
96412|NCT01795144|"~     The purpose of this study is to explore the mechanisms of metabolic control in monogenic~     diabetes patients treated with sulfonylurea medications.~   "
96413|NCT01795131|"~     Nutritional anemia is a major public health problem among children and women in developing~     countries. Despite ongoing national program of supplementing pregnant women with~     iron-folate, prevalence of anemia is 39% among pregnant women and 78% among infants in~     Bangladesh. Vitamin B12 deficiency is a more prevalent cause of megaloblastic anemia than~     folate in many developing countries. This data raises the interest to address the role of~     vitamin B12 deficiency in nutritional anemia. Low dietary intake of animal products, a~     predominant source of vitamin B12 may cause anemia. Besides maintaining normal~     erythropoiesis, B12 is essential for immune function. However, no studies have evaluated the~     effect of maternal B12 supplementation on reduction of anemia and improving immunity of~     their infants. The investigators hypothesize that vitamin B12 supplementation plus~     iron-folate during pregnancy and 3-mo postpartum would: (a) Decrease anemia among mothers~     and infants; (b) Improve vaccine specific cellular and humoral immune responses among~     mothers; (c) Improve vaccine specific immunity in infants by passive transfer; (d) Improve~     DNA methylation and one-carbon metabolism in mother-child pairs; (e) Reduce~     antenatal/postnatal depression. Results from this study will guide and provide support to~     the policy makers to identify effective strategies to reduce nutritional anemia in~     population at risk.~      The investigators aim to conduct a double-masked placebo controlled trial to investigate the~     added effect of vitamin B12 on the iron-folate supplementation among pregnant women. Anemic~     (Hb level <11.0 g/dl) mothers at 11-14 weeks of gestation will be randomized into two~     groups: supplement group will receive 250 ug vitamin B12 plus 400 ug folate and 60 mg iron;~     placebo group will receive folate and iron only. This daily supplementation will continue up~     to 3-mo postpartum. At 26-28 wk of gestation mothers will be given inactivated influenza~     vaccine. Data on anthropometric indices of mothers and children, birth size, infant growth~     and morbidity (mothers and children) throughout the study period will be recorded. 24-h~     dietary recall data will be collected from the mothers bimonthly throughout the study.~     Biochemical indicators of anemia including Hb, vitamin B12, ferritin, folate and~     α-glycoprotein (AGP) will be assessed in plasma of mothers (pre- and post-supplementation)~     and infants (cord blood and 3-months). Additional measurements include serum transferrin~     receptor (sTfR) in plasma and methyl malonic acid (MMA) and total homocysteine (tHcy) in the~     urine of mothers. Plasma vaccine specific antibody responses will be measured in mothers~     (pre- and post supplementation) and in infants (cord blood and 3-months). In breast milk,~     B12, folate and s-IgA will be determined. Genetic polymorphism (one-carbon metabolism) and~     DNA methylation will be studied in mothers and in cord blood.~   "
96414|NCT01794078|"~     Acute exposure of the unacclimatized human body to high altitude leads to health~     complications, such as loss of exercise performance capacity and fatigue. The investigators~     have found that the combination of the xanthine drug theophylline and the endothelin~     receptor antagonist ambrisentan improves the exercise performance capacity of rats under~     simulated high altitude. In young, healthy human volunteers, this combination of drugs has~     not increase toxicity over the single compounds under sea-level conditions. The aim of this~     study is to test whether the combination of theophylline, supplied as its more soluble~     formulation aminophylline, and ambrisentan, are also safe to take under simulated high~     altitude of 4,267 meters, under both resting and exercising conditions. The study also aims~     to test whether this drug combination improves exercise capacity in humans. In this study,~     human subjects will be randomized to one of four treatment sequences and receive the same~     study drug(s) throughout all procedures. The study consists of an initial exercise test,~     followed by two cycles of drug testing at simulated high altitude: Cycle 1 - resting~     subjects receiving study drug at simulated altitude and continually monitored for safety~     with pharmacodynamic and pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with~     the addition of exercise testing. It is hypothesized that the combination of aminophylline~     and ambrisentan is not only safe under simulated high altitude, but also improves exercise~     performance capacity, in comparison with placebo.~   "
96415|NCT01794065|"~     This study is being done to study stent deformation on persons with de novo coronary lesions~     to determine how much deformation takes place and how often. The information gathered from~     the group that receives the Promus element stent will be compared to other groups that~     receive other contemporary drug eluting stents.~   "
96416|NCT01794052|"~     Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these~     two conditions can be detected much early in life and are amenable to interventions at~     primary health care level, the health system in India fails to provide adequate~     interventions at primary health care level which translates to huge burden of undiagnosed~     and uncontrolled hypertension and diabetes in the community. This study aims to design a~     feasible and sustainable evidence-based, decision support-enabled, health care delivery~     model for the management of hypertension and diabetes in the primary health care facilities~     of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs)~     and District Hospital of Solan District, Himachal Pradesh using both qualitative and~     quantitative methods. The design and development of the model will be carried out in the~     initial six months followed by piloting the services at the CHCs and District Hospital. The~     impact of the model on quality of care will be assessed in a pre-post design measuring~     changes in both clinical and process indicators.~   "
96417|NCT01794039|"~     This randomized phase II trial studies how well pomalidomide and dexamethasone work compared~     to lenalidomide and dexamethasone in treating patients with multiple myeloma that has~     returned after a period of improvement (relapsed) or did not respond to previous treatment~     with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system~     kill cancer cells and may also prevent the growth of new blood vessels that tumors need to~     grow. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work~     better by making cancer cells more sensitive to the drugs. It is not yet known whether~     pomalidomide and dexamethasone or lenalidomide and dexamethasone are effective in treating~     patients with relapsed or refractory multiple myeloma.~   "
96418|NCT01794026|"~     Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced~     disease stateS for the patients in which the surgery may be unnecessary to perform. Although~     there are many imaging techniques for this purpose, sensitivity and specificity of these~     techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and~     involvement of lymph nodes beyond D2 may prevent surgical procedures.~      Removal of the determined lymph nodes according to the type of the surgery is the accepted~     surgical method. However, accurate determination of malignant lymph nodes may prevent~     dissection of some groups of the lymph nodes. These findings may cause a new definition of~     gastric lymph node dissection.~   "
96419|NCT01795105|"~     This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean~     regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA~     Notification No. 2010-94 dated 27 December 2010).~   "
96452|NCT01794676|"~     This study is being conducted to identify altered genetic factors that may exist and~     influence endocrine cancers in unrelated MEN1 families with different cancers. A grading~     system will be developed for endocrine cancers, including pancreatic cancers, thymus gland~     cancers, parathyroid disease and MEN1 syndrome as low-risk and high-risk to improve~     screening and timing of surgery.~   "
97527|NCT01780493|"~     To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy~     technique.~   "
96420|NCT01795092|"~     This is a randomized, controlled study to compare patients evaluated by primary care~     physicians alone versus patients who are additionally evaluated by a dermatologist at the~     primary care physician‟s office, aiming to demonstrate that visits to the primary care~     physician‟s (PCP) office that involve both the PCP and an on-site dermatology consultation~     will reduce hospital admission rates. The hypothesis of this study is that obtaining~     outpatient dermatology consultations during a patient‟s initial presentation to a primary~     care office will reduce admissions for cellulitis with accuracy. The primary objective will~     be to measure the difference in the proportion of patients requiring hospital admission~     utilizing a dermatology consultation at the PCP‟s office (active arm) versus primary care~     evaluation alone (control arm) by calculating risk ratios and risk differences. The risk of~     admission for each arm will be assessed once the study has been completed. The secondary~     endpoint will be admission versus discharge home at a dermatology follow-up visit to assess~     accuracy of initial assessment. An additional endpoint will be to determine if any~     differences in frequencies of cellulitis and admission exist based on age and~     immunosuppression. Exploratory analyses will assess the percentage of patients with a~     concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg~     ulceration, tinea pedis, or onychomycosis, as well as the association of fever >100.5 F and~     a history of a prior episode of cellulitis.~   "
96421|NCT01795079|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain and itching associated with burn injury. This study is part of the~     Boston-Harvard Burn Model System. The investigators hypothesize that there will be a~     decrease in pain levels with active stimulation, when compared to sham stimulation, using a~     3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week~     of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after~     initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks~     after the second course of stimulation.~      If a subject receives sham during the experiment, he/she may enroll in an open-label portion~     of the study and receive 10 days of active stimulation.~   "
96422|NCT01795066|"~     For 12 months after approvement by the University of Yonsei institutional review board, of~     the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all~     consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The~     inclusion criteria for this study were the following: diagnosed or suspected solid~     pancreatic masses according to clinical evaluation and imaging studies with need of~     histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the~     following: cystic pancreatic lesions, patients haemodynamically unstable or with severe~     coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000~     cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet~     therapy, pregnancy, inability or refusal to give informed consent, and refusal to~     participate in the study. Patients undergoing anticoagulant or anti- platelet therapy for~     non-critical problems discontinued treatment at least 5 days before the endoscopic~     procedure. Written informed consent was obtained from all patients for the procedures~     performed and participation in the study, and the study protocol was approved by the~     University of Yonsei institutional review board. All patients were underwent the procedure~     under conscious sedation with propofol and midazolam according to the current guidelines.8~     After procedure, the patients were monitored for at least six hours in order to immediately~     detect post-procedural complications and were followed for up to 7 days in order to detect~     late complications.~   "
96423|NCT01795053|"~     A sample of 60 children is randomly assigned to an intervention and a control condition. The~     intervention group receives 15 sessions of child-focused treatment with play training to~     enhance play persistence and intensity. The control group receives the same amount of~     placebo play sessions. The intervention group receives subsequently 15 sessions of parent~     training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD.~     Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings~     in the intervention than in the control group. Play-persistence and -intensity should also~     increase more in the intervention group. An additional effect of a subsequent parent~     training shall furthermore be tested.~   "
96424|NCT01795040|"~     The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS~     symptoms will be evaluated in a randomised controlled doubleblind trail with children aged~     3-6 years.~   "
96425|NCT01795027|"~     Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients~     with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of~     the standard therapies to these patients. But it is still unknown whether it would improve~     more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed~     to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as~     adjuvant chemotherapy after D2 resection in patients with gastric cancer.~      Patients and methods: In this study , patients with histologically confirmed gastric cancer~     who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern~     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized~     1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a~     21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to~     the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14~     days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end~     point is overall survival (OS), and secondary end point is disease free survival(DFS) and~     safety. Final study analysis will be conducted in the end of the 5th year after the last~     patient's enrollment.~   "
96450|NCT01794702|"~     The goal of Phase I of this clinical research study is find the highest tolerable dose of~     clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with~     acute leukemia.~      The goal of Phase II of this study is to learn if decitabine followed by the combination of~     clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of~     this drug combination will also be studied.~      Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells).~     This may cause cancer cells to die.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.~   "
96426|NCT01795014|"~     A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can~     potentially be found in up to 98% of healthy individuals. In fact, the lack of this~     spontaneous retinal venous pulse has been consistently implicated as an indicator of a more~     advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the~     mechanisms behind these change in the retinal venous system are not clear. Some evidence~     suggests that extraocular features such as intracranial pressure (ICP) may play a role in~     regulating the intraocular venous outflow. The reasons for this hypothetical downstream~     resistance to venous outflow are not fully understood, with advances in this field being~     limited by our technological-imposed difficulties in assessing the structures behind the~     globe.~      However, it has been established that the volume of cerebrospinal fluid surrounding the~     optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that~     non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with~     the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range~     (normal tension glaucoma - NTG).~      The investigators will therefore conduct a test to determine if this cerebrospinal volume~     surrounding the optic nerve correlates with the frequency of observation of an otherwise~     signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein)~     Additionally, the investigators will assess if this correlation is different between healthy~     individuals, hypertensive primary-open angle glaucoma or NTG patients.~   "
96427|NCT01795001|"~     The purpose of this study is to gain further insights into the molecular pathogenesis of~     Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug~     therapy.~   "
96428|NCT01794988|"~     The purpose of this study is to investigate whether a psycho-therapeutic approach, group~     Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic~     Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and~     cognitive neural circuitry associated with chronic pain.~   "
96429|NCT01794975|"~     The primary objective of the study is to further investigate whether striatal [11C]ORM-13070~     uptake can be reduced by physiological and pharmacological challenges that increase the~     synaptic concentrations of noradrenaline in the human brain. Each subject will undergo 3 PET~     scans, a baseline PET scan and two scans with noradrenaline challenges: intravenous~     administration of ketamine and oral administration of atomoxetine combined with a cold~     pressor test where the subject's foot is placed in an 8 °C water basin. Eight healthy male~     subjects will be included in the study.~   "
96430|NCT01794962|"~     This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients~     receive a specific diagnosis, leaving the majority of patients diagnosed with non specific~     low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This~     pilot study will compare manual therapy (manipulation and soft tissue treatment)and~     exercises to a classification based biopsychosocial intervention (a cognitive/functional~     approach) as described by Peter O`Sullivan, on a subgroup called flexion pattern~      This pilot study has three specific aims:~      (i) To determine the mean and standard deviation on the numerical rating scale of~     participants in this setting who have a motor control flexion pattern, so that sample size~     calculations for a fully powered randomized controlled trial could be performed.~      (ii) To test the logistical and practical procedures that will be required to perform a~     fully powered randomized controlled trial using these two treatments.~      (iii) To gain a preliminary estimate of any difference in the effect of these two~     treatments, so as to determine if the results of a fully powered randomized controlled trial~     might be clinically important and therefore worthwhile undertaking~   "
96431|NCT01794949|"~     The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by~     poor healing of the stented area. This will require the combined use of blood thinners such~     as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications~     such as clot formation on the stent which may lead to a heart attack. Diabetic patients and~     those presenting with a heart attack at the time of stent placement are at increased risk~     for clot formation. However, little is known of the healing responses after stent placement~     in these populations.~      Currently all patients receiving DES are advised to complete DAPT for twelve months although~     more personalized durations of DAPT based on stent healing would reduce both clot formation~     and potential bleeding from the blood thinners, thereby improving the long-term safety of~     DES.~      Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive~     imaging technique that has the ability to evaluate stent healing at follow-up. Among the~     commercially available coated stents used in the U.S., the zotarolimus eluting stents~     (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both~     preclinical and clinical studies.~      The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity~     stent as detected by OFDI in patients with and without diabetes presenting with ACS.~     Specifically, in this observational study, the study team will investigate non-insulin~     dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent~     placement.~      The investigators hypothesize that healing responses in patients with non-insulin dependent~     diabetes will be similar to those without diabetes presenting with ACS and that a majority~     of patients will demonstrate complete healing as determined by OFDI measurements.~   "
96432|NCT01794936|"~     This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in~     robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is~     simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic~     trocar and placed on structures to determine if there is vascular flow demonstrating an~     audible pulse. During robotic-assisted prostatectomy, identification of vasculature is~     critical in order to prevent hemorrhage and effectively treat the underlying pathology. The~     investigators routinely utilize a combined Doppler ultrasound laparoscopic probe to identify~     vasculature during renal surgery, but Doppler ultrasound usage has not been adopted for~     prostatic surgery.~      From a mechanical standpoint, these combination probes differ from the VTI probe in that~     they are approximately 2 times the diameter of the VTI probe, and the portion of the probe~     utilized for imaging much longer and on the side of the device. The VTI probe is much~     narrower, and the portion of the probe utilized for vessel identification is at the tip of~     the probe. For robotic-assisted prostatectomy, patients will be randomized to VTI~     laparoscopic Doppler System to identify pedicles and neurovascular bundles (NVB) or to~     robotic-assisted laparoscopic prostatectomy with no Doppler probe, which is the current~     standard of care.~   "
96433|NCT01794923|"~     The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical~     Gel versus placebo administered two or three times daily for the treatment of pain~     associated with delayed onset muscle soreness following intense eccentric exercise of the~     elbow flexor muscles.~   "
96513|NCT01793818|"~     Tat Oyi vaccination on seropositive patients could help their immune system to recognize and~     neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune~     response to eliminate HIV-1 infected cells.~   "
96434|NCT01794910|"~     Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single~     delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are~     considered risk factors for urinary incontinence and genital dystopias. Methods: A~     Randomized controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years~     old were selected for functional assessments of their pelvic floors by vaginal digital~     palpation and perineometry. One hundred sixty-five (69.7%) exhibited muscle strength~     deficits and were included in the clinical trial. The participants were distributed into two~     groups based on the delivery route (A, vaginal delivery and B, cesarean delivery) and were~     then randomly subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and~     Groups A2 (n = 39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved~     perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and~     was applied twice per week for a total of 15 sessions. The functional assessment of pelvic~     floor by vaginal digital palpation and perineometry was performed after 15 sessions of~     pelvic´s floor muscles training. The statistical analysis was performed using the~     Mann-Whitney and Z tests at a 5% level of significance.~   "
96435|NCT01794897|"~     The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional~     antipsychotic drug treatment will be evaluated among patients with schizophrenia who have~     been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV)~     augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1~     (HSV-1) exposed early course schizophrenia patients.~   "
96436|NCT01794884|"~     In view of the lack of large-scale clinical study and potent evidence-based medicine, the~     investigators designed a randomized, double-blind, placebo-controlled study to ascertain~     whether preoperative intravenous administration with glutamine can improve the postoperative~     cardiac function and prognosis of adult patients undergoing cardiac surgery. The~     investigators want to detect the levels of myocardial protein O-GlcNAc modification and~     HSP70 expression, changes in sensitive indicators of myocardial injury, systemic~     inflammatory reaction and oxidative stress levels, and to examine the correlation between~     these changes and Clinical manifestations. The ultimate goal of the study is to explore a~     new way for clinical myocardial protection.~   "
96437|NCT01794871|"~     Identify the cause of chronic allograft dysfunction using a combination of comprehensive~     clinical and histologic information in Chinese renal transplant recipients, then to identify~     the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual~     impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor~     [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered~     one of the major causes of CAD, however, recently there has been found most death-censored~     graft losses to be the result of alloimmune or autoimmune injury, with only a minority of~     cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in~     CAD in China is not well analyzed. To improve perception of Neo safety with more local~     evidence, we want to do a retrospective study to identify the cause of chronic allograft~     dysfunction using a combination of comprehensive clinical and histologic information in~     Chinese renal transplantation recipients.~   "
96438|NCT01794858|"~     Background: Acute pancreatitis is characterized by a high mortality rate (10%-15%), and a~     remarkably unpredictable clinical course. Approximately 50% of deaths in acute pancreatitis~     occur early—within the first 14 days—and early mortality is attributable to sequelae of a~     severe systemic inflammatory response syndrome (SIRS), which is associated with multi-organ~     dysfunction syndrome (MODS) that can escalate to renal failure, respiratory failure, and~     death. Significant improvements in acute pancreatitis mortality will demand innovative~     approaches to counteract early organ failure. A series of destructive cellular processes~     begins within minutes of initial pancreatic injury, and the ensuing inflammatory cascade is~     compounded by disease sequelae including edema, ischemia, and tissue necrosis. Early~     interventions to reduce inflammation within the first 36 hours have been shown to have~     significant effects in minimizing progressive organ dysfunction.~      Hypothermia is clinically employed to combat cellular injury and systemic responses~     following ischemia-reperfusion, and is been studied as a mechanism of acute inflammatory~     inhibition in processes including cardiogenic shock, lung injury, local intestinal injury,~     and reperfusion injuries to the lung, liver, and endothelium. In numerous studies, effective~     immunomodulations have been observed including reduction of pro-inflammatory cytokines~     (TNF-α, IL-6), stimulation of anti-inflammatory cytokines (IL-10), inhibition of~     pro-apoptotic JNK signaling, reduction of systemic oxidative stress, and inhibition of~     neutrophils, monocytes, and monocyte-derived macrophages. Most saliently, in the caerulein~     model of murine acute pancreatitis, therapeutic hypothermia has been shown to reduce serum~     IL-1, IL-6, and TNF-α, increased serum IL-10, decrease serum amylase and lipase, lower the~     histological grade of pancreatic injury as compared to normothermic mice, and significant~     survival benefit. Although therapeutic hypothermia is actively employed in the treatment of~     traumatic brain injury, neonatal asphyxia, spinal cord injury, and cardiac arrest, no~     studies have yet been made of its application to acute pancreatitis.~      Hypothesis: Patients treated with therapeutic hypothermia (32-34°C) will sustain reduced~     organ-specific injury in acute pancreatitis.~      Proposal: In a Phase IIa pilot clinical trial, we will examine the effects of therapeutic~     hypothermia on organ-specific outcomes during the early stage of acute pancreatitis. We will~     recruit five patients aged 18 to 80 receiving medically-necessitated ventilator support~     under ICU monitoring with core temperatures ≥36°C and severe acute pancreatitis defined as~     either a Ranson Score ≥7, a CT indicating ≥50% pancreatic necrosis, or a significant~     deterioration in clinical status including dysfunction of two or more organ systems (defined~     by ACCP/SCCM Organ Failure Guidelines, Chest 2009). All patients will receive current~     standard management for severe acute pancreatitis and a standardized protocol for~     application of therapeutic hypothermia and rewarming. Our primary endpoints are~     organ-specific cardiovascular, respiratory, hematological, renal, and metabolic dysfunction~     as measured at 28 days. Logistic Organ Dysfunction Scores (LOD) will be compared before and~     after therapeutic hypothermia, establishing day 4 versus day 1 changes in LOD. Secondary~     endpoints include D-dimer, IL-6, C-reactive protein, APACHE II scores on day 1 and day 4,~     inpatient and ICU length-of-stay, infection, mortality, and hypothermia-associated side~     effects including cardiac arrhythmia, electrolyte imbalance, hyperglycemia, major bleeding,~     and acute pancreatitis. We believe that such a study will supply preliminary answers to our~     chief research questions: does therapeutic hypothermia reduce morbidity as assessed by~     organ-specific outcomes, does therapeutic hypothermia attenuate the steep rise in~     inflammation observed in severe acute pancreatitis, and does therapeutic hypothermia shorten~     the clinical course for these patients.~   "
96439|NCT01794845|"~     Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of~     patients with recurrent unresectable head and neck squamous cell carcinoma.~   "
96440|NCT01794832|"~     Our main hypothesis on the present study is that new parameters such as risk-taking~     behavior, patients motivation, health related quality of life, new biomarkers and more~     precise echocardiography measures in addition to traditional parameters will improve~     pre-operative risk assessment in patients with AS and better guide patients and doctors in~     decision whether to operate or not.~   "
96441|NCT01794819|"~     The aim of this study is to evaluate the usefulness in Russian general practice of~     C-reactive protein testing in patients with acute cough or lower respiratory tract~     infections.~      In addition to studying the effect of C-reactive protein testing on the prescription of~     antibiotics, the purpose is to find out whether the frequency of referral to radiography~     could be reduced.~   "
96442|NCT01794806|"~     The purpose of this study is to clinically and radiographically assess whether the use of a~     ridge preservation technique significantly minimizes alveolar ridge resorption following~     tooth extraction.~   "
96443|NCT01794793|"~     The purpose of this study is to allow continued use of pasireotide in patients who are on~     pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical~     Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.~   "
96444|NCT01794780|"~     This multi-center study is designed to describe natural history of disease, treatment and~     health care products in physician-diagnosed COPD patients who require adding daily~     maintenance therapy in real world.~   "
96445|NCT01794767|"~     The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes~     a longer or equal duration of patency of peripheral venous catheters, compared with heparin~     solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge~     catheters Will be included in the study.The study will assess in particular:~        -  the difference of permanence in situ of the device~        -  the difference in incidence of complications (in detail: obstruction, phlebitis,~          thrombocytopenia, systemic anticoagulation)~        -  the difference in costs between use of saline normal saline 0.9% NaCl solution and~          heparinized 50 U / ml.~   "
96446|NCT01794754|"~     The purpose of the study is to investigate if occupational therapy may delay or prevent the~     need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled~     for surgery in the CMC-joint.~      Our study hypothesis is that compared to participants in the intervention group,~     significantly more participants in the control group have received CMC-surgery after two~     years.~   "
96447|NCT01794741|"~     This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with~     allergic rhinitis~   "
96448|NCT01794728|"~     The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity~     to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson~     University Hospital (TJUH). Additional information on their existing co-morbid conditions,~     an inventory of their prescribed medications, and details regarding the type of treatment~     interventions (over the counter analgesia and other comfort practices) they report using~     will be collected.~   "
96453|NCT01794663|"~     When a patient receives a kidney transplant particularly if the kidney is from an older~     donor or one who has had the kidney removed after their heart has stopped, there is a risk~     that the newly transplanted kidney may not function immediately. If the delay in function~     means that dialysis is needed in the first 7 days after the transplantation then this is~     known as delayed graft function or dDGF. Also delayed graft function that does not require~     dialysis but is present because the serum creatinine does not fall sufficiently is known as~     functional delayed graft function or fDGF. This problem is often due to an excessive~     inflammatory reaction to not having had a blood supply between the time of donation and~     transplant.~      OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be~     partly responsible for increasing the risk of this inflammation. It is hoped that the~     effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from~     occurring.~      The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF~     as well as improving other measures of kidney function and the overall safety of the~     antibody. In the first part of the study, each patient received an Infusion of one of three~     possible doses of OPN-305 or a placebo and in the second part the most suitable dose of~     OPN-305 and a placebo would be used. The purpose of this second part of the study is to find~     out if a dose of OPN-305 which has already been tested in an earlier part of this study can~     prevent kidney graft dysfunction. For the purposes of this study, kidney function will be~     assessed using the composite of delayed graft function (dDGF) because dialysis is necessary~     in the first 7 days and functional delayed graft function that does not require dialysis but~     is present because the serum creatinine, a key measure of renal function, does not fall~     sufficiently (fDGF) in the first 7 days post-transplant.~      Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft~     function of patients who have completed the 6-month post-transplant period under Part A or~     Part B of OPN305-102.~   "
96454|NCT01794650|"~     The investigators hypothesise that manipulating the glycaemic index of the meal after~     exercise and before sleep will help prevent Type 1 diabetes individuals experiencing~     hypoglycaemia.~   "
96455|NCT01794637|"~     End - stage liver disease can cause many problems to the patients including fatigue,~     weakness,jaundice, confusion, abdominal pain and distension. Another important problem is~     the cardiovascular system (heart and blood vessels). There will be the impairment of heart~     function to pump blood to the distal part of the body. Blood vessels are also affected by~     the imbalance of chemical agents which are not detoxified by diseased liver, resulting in~     impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process~     is still poorly understood.~      This is a study about the peripheral vascular dysfunction by means of vascular occlusion~     test (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce~     distal part ischemia), then deflated and observing the distal tissue oxygenation~     (StO2)change by the probe (Near-infrared spectroscopy : NIRS) at the hand. From our~     knowledge, there is no study in patients undergoing liver transplantation.~      The study investigator would like to observe the change in peripheral tissue oxygenation in~     different time points during the liver transplantation. We hypothesize that there is a~     change in microcirculatory function and StO2 in end-stage liver disease patients detected by~     VOT and NIRS.~   "
96456|NCT01794624|"~     TMD is a poorly understood chronic pain disorder that affects up to 15% of the adult~     population, notably impacting women, is linked to greater healthcare utilization, and~     associated with multiple pain-related co-morbidities. Pain-related catastrophizing (CAT) and~     sleep continuity disturbance (SCD) are well established modifiable risk factors for TMD and~     other idiopathic pain conditions. Neither the causal status nor the neurobiological~     mechanisms by which these factors exert their effects on clinical pain have been~     established. We propose that CAT and SCD influence clinical pain through shared alterations~     in pain modulation and key neurobiological pathways, including amplified inflammatory~     activity, autonomic activity, and adrenocortical functioning. Beyond these shared~     mechanisms, however, we propose to determine whether pre-sleep CAT increases cortical~     arousal during sleep. The cognitive dimensions of pre-sleep arousal, particularly rumination~     and negative sleep-related thoughts, are central to the phenomenology of insomnia. Extending~     this notion, we propose that CAT in those experiencing ongoing clinical pain fosters sleep~     disturbance owing to increased pre- and peri-sleep cognitive arousal. Moreover, we propose~     that pre-sleep CAT is related to subtle variations in objective indices of fragmented sleep~     (e.g., cortical arousal). We will examine key hypotheses derived from this framework using a~     brief, prospective randomized experiment, which will permit careful analysis of the temporal~     patterning of how changes in either CAT or SCD influence each other and contribute to~     alterations in pain modulatory systems, key nociceptive mechanisms, and clinical pain.~      Women experiencing at least moderate chronic TMD pain (N=225) who demonstrate at least mild~     trait catastrophizing and meet at least subclinical insomnia criteria (SCD) will be randomly~     assigned to: 1) cognitive therapy for catastrophizing (CT-CAT); 2) behavior therapy for~     sleep disturbance (BT-SCD); or 3) TMD education (Control). Assessments of clinical pain,~     sleep disturbance, catastrophizing, pain sensitivity and modulatory systems, and indices of~     inflammatory activity, adrenocortical function and autonomic balance will be completed at~     baseline, 4 weeks (mid-manipulation) and 8 weeks (post-manipulation). Clinical pain, sleep,~     catastrophizing and covariates will additionally be measured at 16 weeks (follow-up).~   "
96457|NCT01794611|"~     C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is~     used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes~     (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider~     and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and~     Macintosh laryngoscope during routine intubation in adult patients.~   "
96458|NCT01794598|"~     Purpose of the Study: The significant impact of depression on the poor prognosis and~     functional restrain, recognition and successful treatment of depression in patients with~     Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients.~     However, depression comorbid with CHF has been overlooked in the real practice. Therefore,~     the investigators are proposing a study to 1) assess the prognostic impact of depression in~     patients with stable CHF who have been managed as outpatients, and 2) assess whether~     provision of depression education to CHF patients will improve the care of depression.~      Patients with chronic heart failure are enrolled into this study with a half of them are~     randomly assigned to receive a packet of depression education materials and then other half~     not. Participants and investigators both are blinded to the assignment. All the participants~     are provided a toll free phone number to contact the research team as needed. Depressive~     symptoms and patients knowledge of depression are assessed at baseline prior to~     randomization and at 1-month and 6-month following the enrollment.~      Responses of the study participants, such as change of depressive symptoms, and requests for~     psychiatric help are examined between two groups.~   "
96459|NCT01794585|"~     The purpose of this study is to evaluate the effectivenes of a home-based physical therapy~     program designed to improve balance following traumatic brain injury by incorporating the~     use of a virtual reality system.~   "
96460|NCT01794572|"~     In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow~     (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome~     inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem~     Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to~     healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation.~     Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to~     realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered~     to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study,~     the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a~     dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting~     Toxicities (DLT). An extended cohort will further in a phase-2 setting.~   "
96461|NCT01794559|"~     This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate~     the effectiveness of PEER Interactive to inform treatment in subjects with a primary~     diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus~     treatment as usual, as determined by the investigator. The primary measurement for~     improvement of the subjects depression will be a self-evaluation questionnaire, Quick~     Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also~     collect information on their clinical global improvement and any reduction in adverse~     events.~   "
96462|NCT01794546|"~     Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing~     childhood obesity is a top priority among pediatricians in primary care settings. However,~     effective treatment typically is multidisciplinary, and most practices currently do not have~     the infrastructure for coordinating integrated care. With the advent of the Affordable Care~     Act (ACA), innovative systems for building multidisciplinary teams to provide integrated~     care through a patient-centered medical home will be at a strategic advantage. The use of~     electronic technologies for delivering health-related information or services, known as~     telehealth, is an innovation with the potential to streamline integrated care and transform~     interventions for chronic diseases. We propose a pilot study to evaluate telehealth for~     treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics).~      Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40)~     will be randomly assigned to an immediate intervention group or a wait list control~     group. Subjects in the immediate intervention group will begin the 6-month telehealth~     intervention at the time of enrollment in the study and then receive general patient/family~     counseling from their primary care providers (PCPs) at routine office visits during a~     6-month follow-up period. Those in the wait list control group will receive general~     patient/family counseling from their PCPs for 6 months followed by the telehealth~     intervention for 6 months. Thus, the total duration of participation in the study for each~     subject will be 12 months. The telehealth intervention will include dietary, physical~     activity, and behavioral management counseling provided by videoconferencing from the OWL~     clinical providers at Boston Children's Hospital to children in their homes, or at a~     telehealth station at Wareham Pediatrics.~   "
96463|NCT01794533|"~     Achievement of a deep and long-durated anesthesia is vital before most endodontic~     procedures; therefore, the investigators conducted this study to compare the local~     infiltration effect of epinephrine-containing lidocaine with/ without fentanyl on depth and~     duration of anesthesia in maxillary molars with painful irreversible pulpitis.~   "
96464|NCT01794520|"~     The primary objectives of this study are to assess the safety profile, characterize~     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and~     recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in subjects with~     relapsed or refractory multiple myeloma. This study will also assess the safety profile and~     PK of venetoclax in combination with dexamethasone in subjects with t(11;14)-positive~     multiple myeloma.~   "
96465|NCT01794507|"~     The primary objectives of this study are to assess the safety profile, characterize~     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and~     the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed~     /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard~     therapy.~   "
96466|NCT01794494|"~     Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This~     condition gives great suffering for the patients in terms of pain, wounds and often~     developing gangrene. Untreated, the condition has a high risk of amputation. In Sweden, the~     majority of the patients are investigated and evaluated for treatment. Treatment is carried~     out either by traditional open bypass surgery or balloon dilatation technology (endovascular~     treatment). The latter method is still under development, and studies have shown that the~     treatment has less local and systemic complications than bypass surgery. It is also shown~     that the method has a limitation in that the treatment effect is less durable. What is the~     role of minimally invasive technologies should have in the future is unclear, mainly due to~     its efficiency and cost-effectiveness compared with bypass surgery are not evaluated. In a~     prospective observational study we intend study the effectiveness, cost-effectiveness and~     impact on quality of life in patients undergoing treatment for critical CLI with bypass~     surgery or endovascular treatment in Västra Götaland Region (VGR). All patients over a~     period of two years, which undergo treatment for CLI with either of the two methods will be~     included in the study. Patients will be followed up with regard to the clinical efficacy and~     life qualifying small after treatment at, respectively one, 12 and 24 months. Cumulative~     care costs are calculated and estimates of cost are made. This study aims to increase~     knowledge about the role of endovascular treatment of CLI shall have in the future.~   "
96467|NCT01794481|"~     The purpose of this study is to evaluate the potential benefit of an individualized~     resistance exercise-training program during radiotherapy for patients with locally advanced~     head and neck cancer.~   "
96468|NCT01794468|"~     Background: Conditions of reduced perfusion are characterized by redistribution of blood~     flow away from the skin to more vital organs.~      Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor~     in detecting changes in perfusion in critically ill patients.~      Preliminary Study~      Study Population: critically ill patients in a general ICU~   "
96469|NCT01794455|"~     This pilot proposal will test the hypothesis that altered cerebral vessel reactivity and~     cerebral hypoperfusion (decreased blood flow to the brain) is a core mechanism underlying~     the relationship between vascular disease and depression in older adults. The long-term~     objective of this line of research is to: A) determine the relationship between vascular~     reactivity, cerebral hypoperfusion and the persistence of late-life depression and B)~     determine if improving cerebral perfusion with angiotensin receptor blockers (ARBs) improves~     depression outcomes.~   "
96470|NCT01794442|"~     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma.~     Recent findings have confirmed that there is a direct correlation between the levels of~     venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a~     decrease in retinal cell metabolism.~      However, glaucoma patients have been suggested to have a different pattern in retinal venous~     circulation. For instance, the observation of a visible pulsating central retinal vein is a~     phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in~     less than 50% of glaucoma patients. While the nature of these venous changes are not year~     clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous~     pressure due to some obstruction from both ocular or extraocular structures. This~     undetermined increase in venous pulse pressure could then significantly decrease perfusion~     pressures and therefore further decrease oxygen supply to the retinal tissues.~      The investigators will therefore try to determine if there is a significant difference~     between the oxygen saturation of the retinal vessels in both glaucoma patients with and~     without a visible pulsating central vein~   "
96471|NCT01794429|"~     To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can~     induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic~     spectrum.~      The investigators will also examine possible associations between GLP-1 treatment and~     peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1~     analogue treatment will be associated with the effects/changes on cognition and subjective~     quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment~     will associated and correlated with changes in the brain, functional magnetic resonance~     imaging (fMRI).~   "
96472|NCT01794416|"~     The investigators aimed to compare two approaches thoracoscopic epicardial ablation and~     endocardial catheter ablation after failed initial catheter ablation in patients with~     paroxysmal atrial fibrillation.~   "
96473|NCT01794403|"~     Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5~     fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions~     with respect to two-year failure defined as a positive biopsy two years post treatment~     completion or earlier evidence of biochemical or clinical failure.~   "
96474|NCT01794390|"~     Randomised, cross sectional, observational study evaluating inhaler device critical errors~     (errors that could affect dose delivery to the lungs) for the Pulmojet inhaler compared to~     Diskus or Turbuhaler in asthma and COPD patients receiving regular maintenance inhaled~     steroid therapy.~   "
96475|NCT01794377|"~     The purpose of this study is to evaluate the efficacy of 2 physical exercise training~     programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60~     subjects will be randomized into 2 groups. The first program will be consist of an interval~     strength training for 30 min on bicycle ergometer (which include strengthening exercises in~     an high intensity interval training). The second program will be conducted at a relatively~     low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by~     indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables~     per day during all the intervention. The intervention will last 9 months in total : 5 month~     at the hospital fallow by 4 month at home.~   "
96476|NCT01794364|"~     The primary purpose of this trial is to evaluate the safety and tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy~     volunteers.~   "
96477|NCT01794351|"~     This study investigated the potentially cognitive enhancing effects of 500mg~     trans-resveratrol in healthy, young humans.~   "
96478|NCT01794338|"~     This study evaluates the outcomes of patients who have been treated with Strattice or Gore~     Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study~     is to collect information and evaluate the outcome of your surgery. Synthetic (man made)~     mesh has been shown to provide durable long-term outcomes; however, this type of mesh should~     not be used in patients at risk of developing an infection. Therefore, to address the~     challenge of finding an artificial strengthening material to repair complicated hernias in~     patients that could potentially develop surgical infection, two types of non-permanent~     materials have been developed, including biologics and bioabsorbables. Biologic mesh is made~     of living tissue and bioabsorbable mesh is made of synthetic material that is gradually~     absorbed by the body over time. The purpose of this study is to allow surgeons to compare~     the postoperative course of patients associated with these two mesh types to decide which~     material will improve the outcomes of their patients with complicated abdominal wall~     defects. To date there is no evidence to suggest that either mesh type is superior or safer~     than the other.~   "
96479|NCT01794325|"~     Transradial approach (TRA) reduces vascular complications and access related-bleeding~     compared to transfemoral approach (TFA). However, this technique has been related to higher~     radiation exposure during coronary angiography and percutaneous coronary intervention.~     Previous studies have shown that TRA demands a long learning curve, and procedure success~     rate increases with operator's experience. Our hypothesis is that the higher radiation~     exposure during TRA is not a technique issue, but due to operator's expertise.~      The aim of this study is to evaluate whether experienced operators with either TRA or TFA~     can perform diagnostic coronary angiography with similar radiation exposure.~   "
96480|NCT01794312|"~     The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.~   "
96481|NCT01794299|"~     The purpose of this study is to determine whether ATIR is safe and effective in reducing~     transplant-related mortality and improving overall survival, when infused in patients with a~     hematologic malignancy following a T-cell depleted stem cell graft from a related~     haploidentical donor.~   "
96482|NCT01794286|"~     Specific Aim: To improve childhood immunization rates by utilizing automated Electronic~     Health Record-derived provider-specific performance feedback reports, coupled with automated~     Electronic Health Record-derived trigger alerts.~      Hypothesis: The automated Electronic Health Record-derived provider-specific performance~     feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of~     age, when coupled with automated Electronic Health Record-derived trigger alerts, compared~     with trigger alerts alone.~   "
96483|NCT01794273|"~     The effects on brain perfusion of the two currently vasopressors used to treat accidental~     hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not~     known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action~     and according to published reports~   "
96484|NCT01794260|"~     The objectives of this study are to assess short term efficacy and safety of of topical~     preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering~     from osteoarthritic pain~   "
96514|NCT01793805|"~     This is a study to collect and analyze tissue specimens from metastatic colorectal cancer~     (mCRC) patients for the development of a molecularly profiled tissue repository for the~     primary purpose of maintaining a patient registry for future clinical trials based on the~     molecular profile of the tumors. The main purpose of testing these tissue specimens is to~     identify genetic alterations or biomarkers associated with colorectal cancer such that if~     new agent(s) become available, particularly those that target these genetic~     alterations/biomarkers, participants may be offered the opportunity to take part in a~     National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.~   "
96485|NCT01794247|"~     5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia~     because it has been blamed responsible for the so-called transitory neurological syndrome~     (TNS). This entity appears particularly in patients operated on lithotomy and knee~     arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out~     of 10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery~     cases. Other local anesthetics are not competitive with general anesthesia in time to be~     discharged home from the SDS unit. The magnesium ion is well-known for its protective~     properties on cells with electrical activity. The objective is to confirm that the magnesium~     ion added as adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this~     hypothesis could be confirmed, the practical and theoretical consequences would be~     far-reaching.~      The method to achieve our objective would be a double-blinded randomized clinical trial~     considering two groups of intrathecal lidocaine: with and without added IT magnesium.~   "
96486|NCT01794234|"~     This observational study will evaluate the efficacy and safety of Pegasys (peginterferon~     alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with~     nucleoside (nucleotide) analogues. Data will be collected from patients treated according to~     the current Summary of Product Characteristics and local standard of care and regulations~     during 48 weeks of treatment and 24 weeks of follow-up.~   "
96487|NCT01794221|"~     The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive~     decreased the incidence of recurrent adhesions after circumcision. The investigators~     hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl~     cyanoacrylate skin adhesive.~   "
96488|NCT01794208|"~     The aim of the current study is the determination of the recommended standard treatment dose~     of FSH-GEX(TM) in women undergoing ICSI (intracytoplasmic sperm injection) treatment as~     assessed by follicle growth.~   "
96489|NCT01794195|"~     Use lay language.~      Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of~     Parkinson's disease. Depending on methodological approach of the study, its prevalence is~     estimated to be between 16 and 51%.~      Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which~     seems to play a central role in the control of mood and motivation. The subcortical~     components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and~     the constituents of the limbic system (particularly the hippocampus and amygdala), all of~     which are located deep inside the brain (18). The hypothesis is that depletion of striatal~     dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical~     circuits results in hypofunction of these circuits and the loss of frontal cortical~     activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex~     and the prefrontal cortex~      The objective of this study is to explore, using diffusion weighted MRI, the regions of the~     brain which are proposed to play a role in motivation in apathetic Parkinson's disease~     patients and to define more precisely the relation between dopaminergic fibres and the~     meso-cortico-limbic system with the help of tractography methods~   "
96490|NCT01794182|"~     This is a randomized, multi-center, prospective, double blind study. The primary objective~     is to demonstrate the efficacy of RP-1127 compared to placebo in subjects with a severe~     anterior circulation ischemic stroke who are likely to develop malignant edema. This~     objective will be addressed by comparing the proportion of RP-1127 treated patients and~     placebo treated patients with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive~     craniectomy (DC).~   "
96491|NCT01794169|"~     The purpose of this study is to determine whether Azacitidine consolidation is superior to~     standard DA consolidation treatment of acute myeloid leukemia in first complete remission in~     elderly patients.~   "
96492|NCT01794156|"~     Obsessional compulsive disorder (OCD) is a very debilitating psychiatric problem which~     affects around one million Canadians and their families. Obsessions are intense~     preoccupations about bad, harmful, dangerous, shocking or unlucky events which 'may' occur~     and which drive sufferers to perform time consuming and distressing compulsive rituals to~     prevent the possible event occurring. The current psychological treatment of choice is~     cognitive behavior (CBT) therapy which focuses on treating OCD by reducing obsessional~     anxiety about the likelihood and the consequences of the preoccupying event. A rival~     cognitive model termed the inference-based therapy (IBT), developed by the principal~     investigator and co-workers, considers that the OCD begins with the initial doubting~     inference 'maybe something is wrong' and focuses on changing the reasoning behind this~     doubting inference which often trumps the common sense conviction that there is no reason to~     doubt. This clinical trial randomly allocates participants to either IBT or CBT treatment~     condition or to a third generic mindfulness condition. The latter condition is a~     non-specific meditational-based training which has shown evidence of reducing stress and~     anxiety across a number of psychiatric problems including OCD. Two hundred and forty people~     will be recruited over a 5-year period from two principal sites (Montreal and~     Gatineau/Ottawa) with which the principal investigator and co-investigators have clinical~     links. Therapy will be administered by trained professionals following a treatment manual~     specific to each approach. The therapy will last a maximum of six months or until the point~     when the person achieves a non-clinical status. The patients will be assessed pre, post, and~     at six months following treatment on standard evaluation instruments as well as on~     subjective measures. We expect the IBT to be superior in terms of number of participants~     responding to treatment, rapidity of improvement and gains at follow-up.~   "
96493|NCT01794143|"~     The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used~     diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and~     patient-centered outcomes.~   "
96494|NCT01794130|"~     The aim of this investigation is to determine the incidence of silent interstitial pulmonary~     edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a~     suspected association with acute mountain sickness (AMS), co-morbidities and endothelial~     dysfunction (marker of hypoxia responses, endothelial damage and inflammation).~   "
96515|NCT01793792|"~     The purpose of this study is to evaluate the safety and efficacy of the Low Profile~     Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when~     used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.~   "
96524|NCT01793675|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative~     treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%).~     However, many patients cannot find an HLA-matched donor. haploidentical donor is an~     alternative stem cell source.~      the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can~     improve the survival of patients with myelodysplastic syndrome~   "
96495|NCT01794117|"~     Background:~        -  Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the~          immune system attacks the body s tissues. These diseases cause painful and itchy skin~          rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating~          these diseases suppress the immune system. However, they can cause severe side effects~          when taken over a long period of time.~        -  IL-1 is a small protein that may be important in causing the inflammation seen in~          pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been~          effective in treating some inflammatory conditions such as rheumatoid arthritis.~          However, anakinra has not been studied for use in patients with pustular skin disease.~          Researchers want to see whether anakinra will be effective in treating pustular skin~          disease.~      Objectives:~      - To see if anakinra can be used to treat inflammatory pustular skin disease.~      Eligibility:~      - Individuals at least 18 years of age who have inflammatory pustular skin disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Their disease~          will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may~          also be collected.~        -  Participants will have an initial visit to receive the first dose of anakinra. They~          will be shown how to give themselves daily injections of anakinra.~        -  Participants will take anakinra for up to 12 weeks as long as there are no severe side~          effects. During this time, they will keep a study diary to record the severity of any~          rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary~          to their study visits.~        -  Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored~          at these visits with blood tests, urine tests and physical exams. Depending on the~          effects of the treatment, participants may have the dose of anakinra increased or~          decreased.~        -  Participants will have a final study visit 4 weeks after they stop taking anakinra.~   "
96496|NCT01794104|"~     Background:~      - Indenoisoquinoline LMP400 is an experimental cancer treatment drug. It damages DNA in~     tumor cells. Tumor cells with damaged DNA may die, resulting in cell death. Researchers want~     to see if this drug is a safe and effective treatment for solid tumors and lymphomas that~     have not responded to earlier treatment.~      Objectives:~      - To see if Indenoisoquinoline LMP400 is a safe and effective treatment for advanced solid~     tumors or lymphomas.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or lymphomas that have not~     responded to treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor samples may also be collected. The size and location~          of the tumors will be determined with imaging studies.~        -  Indenoisoquinoline LMP400 is given in a 28-day cycle. Participants will receive the~          drug by intravenous infusion on days 1, 8, and 15 of each cycle, followed by a break of~          13 days without the drug.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor~          samples will be optional.~        -  Participants will continue their cycles of treatment as long as the cancer does not~          grow and there are no severe side effects.~   "
96497|NCT01794091|"~     People with diabetes are at an increased risk of heart attacks and heart failure, and it is~     important to be able to treat people with diabetes who are at risk for heart disease to~     prevent these outcomes. This study is looking at the importance of diffuse scar tissue~     that is found in the heart of diabetic people. We have discovered a way to detect diffuse~     scar tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on~     diabetics with low risk stress test results and follow them for 5 years to see if the~     measure of scar tissue in the heart by MRI is related to events. If this study is positive,~     we will be able to use cardiac MRI scar tissue measurements to target those patients with~     diabetes who are at highest risk.~   "
96498|NCT01794013|"~     The objective of this study is to test whether adding the parent training program using the~     relationship-based approach could help the children with development disabilities (DDs)~     would confer additional benefits over routine clinical care available to both groups in~     terms of improving their development and reducing behavior problems.~   "
96499|NCT01794000|"~     The main purpose of the study is to evaluate the efficacy and safety of the study drug known~     as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants~     with sickle cell disease. The study will also investigate reduction in daily pain in~     children who have sickle cell disease.~   "
96500|NCT01793987|"~     Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa~     is inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms,~     including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects~     close to 5% of the Canadian population(2). When medical therapy fails, patients are often~     referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management.~     Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed~     medical management(3). Traditionally, the microdebrider has been the go-to tool for~     performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun~     to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue~     (with temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding~     than so-called cold surgical techniques (i.e. the microdebrider). In a retrospective study~     by Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount~     of less intraoperative blood loss when the Coblator was used in their surgery, than those~     patients who underwent surgery with the microdebrider. The investigators plan to further~     investigate this in a randomized, controlled fashion~   "
96501|NCT01793974|"~     This is a prospective study that will study adults and has the objective of examining~     'Latent Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by~     genetic factors.~   "
96502|NCT01793961|"~     Rates of driving under the influence of cannabis have risen in recent years. Cannabis is~     involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect~     dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast~     sensitivity disorders could originate difficulties to anticipate and avoid collision with~     objects, especially when objects are in movement. The investigators goal is to examine the~     effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be~     compared to standard references. In addition, since smoking cannabis is always associated~     with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.~      In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36~     no smokers. The investigators will present gratings with different spatial frequencies and~     the investigators will determine contrast thresholds for static and dynamic (moving)~     gratings. The investigators predict that cannabis addicts will present abnormal contrast~     sensitivity especially in case of dynamic presentation of gradings.~   "
96503|NCT01793948|"~     This randomized clinical trial studies metformin hydrochloride in overweight or obese~     patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the~     expression of early tumor makers in breast tissue of patients at increased risk for breast~     cancer~   "
96504|NCT01793935|"~     Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or~     to build resistance to stress or diseases in indigenous medical systems in India for~     centuries. Modern scientific data for WSE indicate several bioactive molecules~     (withanolides, withanosides, indosides, withaferin-A, others) with significant~     immunomodulatory, anti-inflammatory and stress reducing properties.~      This study will examine whether a standardized extract of Withania Somnifera (WSE;~     Sensoril®) will improve total, positive, negative symptoms, and stress in patients with~     schizophrenia. The study will examine whether WSE reduces PANSS positive and negative~     symptoms and stress scores in subjects, and whether these improvements are mediated by~     changes in inflammatory immune indices. An additional aim will determine if patients~     receiving WSE will have fewer adjustments to their psychotropic medications that those~     assigned to placebo. The study will examine whether WSE will re-balance Th1/Th2 ratios~     (cytokine measures) and mediate a reduction of elevated hs-CRP levels. It is hypothesized~     that those subjects whose Th1/Th2 ratios normalize will likely have a greater magnitude of~     clinical improvement versus those subjects whose immune ratios remain unbalanced.~      The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to~     antipsychotic medications in approximately 60 or more patients with schizophrenia with an~     exacerbation of symptoms. If efficacy is affirmed, this low cost extract could be studied~     further, and used quite readily across low, middle and high income countries.~   "
96505|NCT01793922|"~     The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the~     efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It~     is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment~     of therapy-naive patients with idiopathic achalasia.~   "
96506|NCT01793909|"~     This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood~     flow and muscle oxygen uptake. This study will evaluate & compare exercise function during~     single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean~     controls, 15 people with T2DM, and 15 overweight control subjects).~      Differences between the exercise responses in people with T2DM and healthy people will help~     further identify the disease process of T2DM and direct future research of treatments and~     interventions.~   "
96507|NCT01793896|"~     Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects,~     which retard or prevent age-related diseases and prolong life span. Subjects with the~     metabolic syndrome age prematurely, therefore preventive measures should be initiated early.~     The present study intends to demonstrate that physical exercise and/or Mediterranean diet,~     in middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue~     functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and~     accumulation of ROS), by activating several pathways, homologous to CR. The investigators~     plan to study this by using two approaches: 1) A cross- sectional model, in which the~     expression of the mentioned metabolic mediators, indicators of muscle mitochondrial~     biogenesis and muscle oxidative damage will be compared between men with different body~     compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in~     these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in~     subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory~     markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in~     preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured~     preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure~     of a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by~     the patients´ adipose tissue explants. 2) A prospective intervention in~     overweight/moderately obese middle aged volunteers that will be assigned to a~     weight-maintenance period (as a control group), and then randomly y assigned to a~     Mediterranean diet, exercise training or diet plus training. Before and after 3 months of~     intervention the investigators will obtain muscle tissue samples to study the expression of~     Peroxisome proliferator activated receptor (PPAR) gamma coactivator 1 alpha (PGC1),~     uncoupling protein 3 (UCP3), AMP activated protein kinase (AMPK), Sirtuin 1 (SIRT-1),~     mitochondrial DNA and oxidative damage indicators (8-oxo-7,8-dihydro-2-deoxyguanosine~     (oxodG), carboxymethyllysine (CML and its receptor (RAGE)). In vitro studies will evaluate~     the effect of circulating factors from the patients (serum) on LS14 inflammatory and~     adipogenic potential, at baseline and after 3 months of intervention.~   "
96508|NCT01793883|"~     This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus~     placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who~     present to clinic with symptomatic presumptive influenza A or B infection.~   "
96509|NCT01793870|"~     This will be a randomized, open-label, single dose, 4-period, period balanced, crossover~     study. There will be at least 5 days between dosing in each session. The study consists of~     Screening period (30 days prior to Day 1), Treatment period consisting of 4 dosing periods~     (Day 1 is the dosing day and Day 2) and Follow-up period (7-14 days post-last dose).~      The detailed treatment regimen will be A and B (27.5 mg total maximum dose): Single oral~     dose of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol~     powder under fasted conditions; C (33.75 mg total maximum dose): Single oral dose of~     carvedilol 31.25 mg as 25 mg immediate release tablet, a 6.25 mg immediate release tablet~     and up to 2.5 mg of enriched carvedilol powder under fasted conditions; D (27.5 mg total~     maximum dose): Single oral dose of carvedilol 25 mg immediate release tablet and up to 2.5~     mg of enriched carvedilol powder under fed conditions. Approximately 15 subjects will be~     randomized to receive one of four treatment sequences (ADBC, BACD, CBDA, or DCAB).~      The pharmacokinetic sampling and safety data will be collected in the Treatment period (Day~     1 and 2).~   "
96510|NCT01793857|"~     The study is a survey aiming to describe the healthcare seeking behaviour of primary~     caregivers when their child aged 6 months to less than 30 months was suspected to have an~     episode of acute otitis media in Panama.~   "
96511|NCT01793844|"~     This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators~     planed to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to~     random to R-CHOP21, CHOP14 , R-CHOP14 regimen groups after signature the informed consents.~     The patients will receive safety assessment every cycles, and efficacy evaluation every 2~     cycles. Every-two-months follow up will be received after finishing the treatment.~   "
96512|NCT01793831|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles~     in the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria and inflammatory bowel diseases~     (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile~     colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases (CD),~     irritable bowel syndrome (IBS) and constipation have also met with some success. However,~     the results on CD is very limited. This is an initial step into investigating the potential~     efficacy of fecal bacteriotherapy for CD, the investigators propose to determine the~     efficiency, durability and safety of FMT in a series of 30 patients with CD (included cased~     according Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3 but~     without perianal diseases).~   "
96516|NCT01793779|"~     Study Objectives~        1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on~          performance recovery from an acute bout of high intensity resistance exercise.~        2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.~        3. Examine the effect of these recovery modalities on markers of muscle damage,~          inflammation and immune function.~      Subjects~      Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience~     will be recruited. Subjects will be randomly divided into one of four groups: a cold water~     immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).~      Study Protocol~      Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions.~     On the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum~     (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2)~     subjects will perform a lower body resistance exercise session consisting of four sets of~     the squat, dead lift and barbell lunge exercises. All subjects will then report back to the~     HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform~     four sets of the squat exercise only using the same loading pattern and rest interval length~     as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects~     in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water~     at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min~     prior each workout and CW+HMB-FA will be administered together at time points describe~     above.~      Statistical Analysis~      Statistical evaluation of performance and biochemical changes will be accomplished using a~     repeated measures analysis of variance (ANOVA).~   "
96517|NCT01793766|"~     This is a study of overweight men and women. Everybody will receive a very low calorie diet~     to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the~     patients will receive an intervention to activate parts of their brain that can help them~     eat less. The other half of the patient will receive a placebo or sham intervention. The~     intervention will involve a small electric current given every day for 10 days. Everybody~     will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet~     to see if the intervention helps people keep the weight off.~   "
96518|NCT01793753|"~     Background and Aim: An anorectal manometry (ARM) is a common test in the evaluation of~     outlet obstruction in constipation. In children under 6 yo, anesthesia is often used for~     patient comfort and compliance. The choice of anesthesia for ARM varies from center to~     center and includes the use of ketamine, inhalation agents, and propofol. With the increased~     use of propofol, our aim is to determine the effects of propofol on resting anal sphincter~     pressure while performing an ARM under general anesthesia.~      Hypothesis: Propofol administration leads to a decrease in internal anal sphincter pressure.~      Methods: This is a prospective, single center, observational study of the effect of propofol~     on the internal anal sphincter pressure. Pediatric patients between the ages of 2-6 years~     who require an anorectal manometry for chronic constipation will be offered enrollment.~     Anesthesia was required for patient compliance and comfort and conducted by an~     anesthesiologist. Sevoflurane was the inhalational agent used for induction. At~     Massachusetts General Hospital (MGH), 1 mg/kg of propofol bolus is routinely given at~     completion of the ARM test to reduce emergence delirium. The manometric probe was kept in~     place with continuous measurement of baseline internal anal sphincter pressure while~     propofol was administered. We measured changes to internal anal sphincter pressure and time~     to return to baseline.~      Results: The primary outcomes will be change of internal anal sphincter pressure from~     baseline and time to return to baseline.~      Discussion: The proposed investigation may demonstrate that propofol has an effect on the~     internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal~     manometry.~   "
96519|NCT01793740|"~     The majority of school-age children with sickle cell disease (SCD) experience neurocognitive~     deficits, even in the absence of stroke. In particular, deficits in attention and working~     memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal~     of the present proposal is to address feasibility and compliance of a novel computerized~     cognitive training program, Cogmed. Pilot data will also be collected to establish~     preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will~     be identified and approached about participation by their attending physician during~     regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of~     intellectual functioning, a brief cognitive testing battery evaluating processing speed and~     working memory, in addition to questionnaires regarding behavior and quality of life.~     Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist~     control (n=12). Participants enrolled in the computerized CT program will be asked to~     complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).~     Following completion of the program, children and their parents will be asked to return to~     clinic for a follow-up visit. After a five to eight-week waiting period, children in the~     waitlist condition will also be asked to return to clinic for a second visit. Following this~     assessment, participants initially enrolled in the waitlist will be offered an opportunity~     to participant in the intervention. If interested, they will follow the same intervention~     protocol described above. These children will return to clinic for a third visit following~     completion of the intervention. Compliance rate and its confidence interval will be~     calculated for the overall study population. A t-test for binomial proportion with~     continuity correction will be used to examine whether the compliance rate is lower than the~     target. Participants' change in criterion outcomes will be evaluated (i.e., those~     neurocognitive measures such as attention, executive functioning and working memory, that~     are most closely related to the trained tasks).~   "
96520|NCT01793727|"~     A prospective trial evaluating the learning curve associated with the use of a~     videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by~     anesthesiology residents. Hypothesis: The learning curves of both instruments are~     equivalent.~   "
96521|NCT01793714|"~     One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal~     resection with the minimal neurological risk. The presurgical mapping of eloquent areas with~     functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is~     now the gold standard to map language areas. However, BOLD signal is diminished near the~     brain tumor. It is now possible to detect cortical activation with arterial spin labeling~     (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL),~     fASL could be interesting to detect eloquent areas near a brain tumor.~   "
96522|NCT01793701|"~     This will be the first study to assess the clinical feasibility of dose escalation with~     simultaneous integrated boost intensity-modulated radiotherapy for patients with locally~     advanced cervical cancer. Following screening to confirm eligibility patients will commence~     a six week treatment period. After this, patients will be followed up by visits to clinic~     every 3 months for a period of 24 months (2 years). End of study is defined as 24 months~     after treatment. Patients will be followed up for a minimum of 5 years (as per local policy)~     after treatment.~   "
96523|NCT01793688|"~     The purpose of the survey is to study the followings under practical use, regarding the~     safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and~     UNASYN-S KIT for intravenous use (UNASYN).~        1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse~          Drug Reaction)~        2. Incidence status of adverse drug reactions~        3. Factors that may affect the safety and effectiveness~   "
96525|NCT01793662|"~     Patients with severe atherosclerotic occlusive disease can be operated with an~     aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, the vary operation has~     also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally~     invasive as compared to the open ABFB. The cohort studies published so far have shown that~     although a longer operation time with the laparoscopic procedure as compared to the open~     surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer~     systemic complications and earlier reconvalescence.~      However, no randomized control trial has yet been published to compare the two procedures.~      In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC~     type D atherosclerotic lesion shall be randomized to either totally laparoscopic~     aortobifemoral bypass operation (LABFB)or an open ABFB operation.~   "
96526|NCT01793649|"~     This is a randomized, double-blind, cross-over, vehicle-controlled study to determine~     whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects,~     compared to vehicle of 2.8% saline alone.~   "
96527|NCT01793636|"~     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This~     is very difficult to treat and almost all patients will die of their disease within 2 years~     of the diagnosis.~      Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for~     untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF~     which is important in treating kidney cancer. Although the results with this drug are~     impressive, patients develop resistance to the drug and stop therapy. It is currently~     standard practice is to give everolimus when resistance to sunitinib occurs; this is~     associated with clear clinical benefit.~      However the average time to cancer regrowth with everolimus is only 5 months. It is thought~     this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2).~     Therefore further improvement in treating patients is required. AZD2014 is a promising new~     drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in~     renal cancer as it theoretically could may have advantages over everolimus. Therefore study~     compares AZD2014 to everolimus in the setting where everolimus is used as standard of care.~     (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial~     allowing us to quantify the benefit and potential for further development of AZD2014. Repeat~     Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will~     be closely followed up in clinic to ensure safety. A maximum of 122 patients will be~     recruited into this multi centre national trial. The primary goal of the study is to~     investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to~     everolimus.~   "
96528|NCT01793623|"~     Over the past decade, techniques have been refined which permit an enormous amount of~     information relevant to disease mechanisms to be gained from the examination of heart~     tissue. The Cardiovascular Institute has extensive experience with these techniques, and has~     utilized them to examine other heart disease substrates. In this study, the investigators~     propose to obtain heart tissue at the time of cardiac surgery which would otherwise be~     discarded. Their plan is to examine this tissue and correlate their findings with clinical~     data. Their hope is that the proposed study will provide insight into atrial physiology,~     including the molecular mechanisms underlying atrial disease and the potential development~     of atrial fibrillation (AF).~   "
96529|NCT01793610|"~     This small (pilot) study is designed to provide information on whether psychotherapy~     combined with the drug MDMA is safe and helpful for people with posttraumatic stress~     disorder (PTSD). The researchers plan to use the results of this study to design further~     studies. This study will compare two doses of MDMA active dose 1, two doses of MDMA active~     dose 2, or comparator-dose MDMA. There will be an initial dose possibly followed one and a~     half to two and a half hours later by a second dose half the size of the first dose. The~     study will measure symptoms of PTSD, depression, general psychological well-being and sleep~     after a low dose versus active doses of MDMA. Subjects experiencing pain or tinnitus~     (ringing in the ears) at the start of the study will report on levels of pain or tinnitus~     during the study. The study will also examine whether following the standardized treatment~     is related to changes in PTSD symptoms. Subjects will be prepared for MDMA-assisted~     psychotherapy prior to the first session, and he or she will work with the same pair of~     therapists after having two MDMA-assisted psychotherapy sessions, with the second session~     occurring three to five weeks after the first session. Symptoms of PTSD, depression, general~     psychological well-being, feeling that you or the world are unreal (dissociation), potential~     positive effects of traumatic events and sleep quality will be assessed one month after the~     second MDMA-assisted session. Cognitive function will be measured one month after the second~     MDMA-assisted session. Participants who received comparator-dose MDMA can enroll in Stage 2,~     wherein they will have three MDMA-assisted psychotherapy sessions. People who received~     either active-dose MDMA will have a third MDMA-assisted session. Cognitive function will be~     measured again after two months last Stage 1 or Stage 2 MDMA-assisted session.Subject PTSD~     symptoms, depression psychological symptoms, other symptoms and sleep two months after their~     final MDMA-assisted session and at least 12 months after they began the study.~   "
96530|NCT01793597|"~     Patients who have a heart attack are regularly treated with either clopidogrel or~     ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass~     surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel.~     The reason for this difference cannot be explained on the basis of the study. One possible~     explanation is that the reversible binding of ticagrelor is advantageous because when new~     platelets are released, they are inhibited by the drug. Because clopidogrel binds~     irreversibly it cannot redistribute. The investigators will recruit patients who are~     scheduled for surgery after an acute coronary syndrome who have been treated with either~     ticagrelor or clopidogrel. After the patient provides informed consent, the investigators~     will review their medical record,record information and on the day after surgery the~     investigators will take one sample of blood. That blood will be analyzed for evidence of~     platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the~     reactivity of young platelets, and the concentration of inflammatory cytokines. The~     investigators hypothesize that the evidence of platelet activation (platelet microparticles~     and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in~     patients who have been treated previously with ticagrelor.~   "
96531|NCT01793584|"~     The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety,~     and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to~     abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through~     a randomized surgical trial.~   "
96532|NCT01793571|"~     An prospective double blinded randomised trial,whether the use of an perioperative~     echoguided unilateral TAP block has an superior effect on postoperative pain after open~     hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.~   "
96538|NCT01793493|"~     The Allena-Mente study is a randomized, controlled, single-blind trial assessing the~     efficacy of cognitive stimulation (CS) compared to an active control group, participating to~     sanitary education lessons (AC). This non-pharmacological intervention is delivered to Mild~     Cognitive Impairment (MCI) and cognitively healthy individuals with first-degree relative~     with dementia (NDFAM).~   "
96533|NCT01793558|"~     This study should evaluate whether newborns during cesarean section are endangered to get~     hypothermic while bonding on the mothers chest.~      Therefore, the investigators want to investigate the effects of active cutaneous warming of~     the mothers and babies during intraoperative bonding. The investigators plan to enroll 40~     parturients scheduled for elective caesarean section to receive passive insulation or~     forced-air skin surface warming. The investigators will measure core temperature of the~     newborns and their mothers. The investigators hypothesize that newborns became most often~     hypothermic without active warming during the bonding procedure and that active warming will~     be able to decrease the number of hypothermic newborns significantly.~   "
96534|NCT01793545|"~     Background:~      - Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an~     early stage, it can be treated more easily. Women who have this type of cancer often have a~     history of irregular menstrual bleeding. They may also have abnormal findings during~     gynecologic exams. Pap smears and cervical cell collection may be able to collect cell~     samples for cancer testing. However, samples from the vagina or endometrium may produce more~     accurate results. Researchers want to collect vaginal and endometrial cell samples to~     improve their tests for and understanding of endometrial cancer.~      Objectives:~      - To collect vaginal and endometrial cell samples to study endometrial cancer.~      Eligibility:~      - Women at least 18 years of age who have had symptoms of abnormal uterine or~     post-menopausal bleeding, or abnormal ultrasound findings.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a pelvic exam. Before the exam, they will insert a small tampon~          in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon~          will then be removed and collected for the study.~        -  During the pelvic exam, tissue will be collected from the uterine lining with a special~          brush. An additional sample (biopsy) will be collected from the lining.~        -  A blood sample will also be collected as part of the study.~   "
96535|NCT01793532|"~     Background:~      - Some people with epilepsy have an epileptic focus, a small part of the brain that is the~     starting point of the seizure. This focus is like an irritant or an inflammation, and helps~     cause the seizure. People with epilepsy that affects the temporal lobe of the brain often~     have an epileptic focus. Researchers want to look at the epileptic focus by using a drug~     that attaches to a protein associated with inflammation. An imaging study with the drug will~     show how much inflammation is in the area of the brain where the seizures start. The drug,~     called [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe~     epilepsy. Its effects will be compared with imaging studies given to healthy volunteers.~      Objectives:~      - To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.~      Eligibility:~        -  Individuals at least 18 years of age who have temporal lobe epilepsy.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have three outpatient visits to the National Institutes of Health~          Clinical Center. The visits will last from 2 to 5 hours.~        -  Participants will be screened with a physical exam, neurological exam, and medical~          history. Blood samples will be collected before the start of the study.~        -  Participants will have a positron emission tomography (PET) scan. This scan will be~          used to look at brain chemistry and function. The study drug will be given during the~          scan to see how well it shows points of inflammation in the brain. Some participants~          will provide additional blood samples during the PET scan.~        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will~          look at the structure of the brain.~   "
96536|NCT01793519|"~     Background:~        -  Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor~          (TNF) inhibitors, that can help decrease joint pain and swelling and can even result in~          RA remission. However, TNF inhibitors may increase risk of serious infections or some~          types of cancer.~        -  It is not clear if people whose RA has been in remission for a long time need to stay~          on the TNF inhibitor to remain in remission. If they can stop taking the TNF inhibitor~          without having their symptoms come back, they will be spared the side effects of these~          medicines. Some studies have shown that people can stay in remission after stopping a~          TNF inhibitor, but other studies have not confirmed it. Researchers want to see if~          people with RA in remission on a TNF inhibitor can stay in remission without this~          medicine. Also there may be a clinical, imaging (MRI, ultrasound), laboratory profile~          that will help to determine which patients remain in remission after stopping these~          drugs.~      Objectives:~        -  To see whether RA remission can continue after discontinuing use of a TNF inhibitor.~        -  To determine if clinical, imaging and immunological measurements can predict which~          participants will flare and which will remain in remission after discontinuing TNF~          inhibitor.~      Eligibility:~      -Individuals at least 18 years of age who have RA that is being controlled with TNF~     inhibitors. We plan to randomize 291 patients.~      Design:~        -  The study has seven visits over about 2 years. Six visits occur in the first year of~          the study, about 12 weeks apart. The final study visit is 1 year after the end of the~          treatment phase.~        -  At the first visit, participants will be screened with a physical exam and medical~          history. They will complete a questionnaire about their RA symptoms. A blood sample~          will be collected. They will continue to take their RA medicines during this time.~        -  The second visit will repeat tests from the first visit. These tests will confirm that~          the RA is in remission. Imaging studies will be performed on the hands, wrists, feet,~          and their connected joints. After this visit, participants will stop taking their TNF~          inhibitors and will start to have injections of a study drug. This drug will be either~          the participant's original TNF inhibitor or a placebo.~        -  There will be follow-up visits at weeks 12, 24, and 36. Participants will have a~          medical history and joint exam. They will also provide blood samples and answer~          questions about their RA symptoms.~        -  At the sixth visit (week 48), participants will repeat the tests and imaging studies~          from the second visit. They will stop taking the study injections.~        -  Continued RA treatment after this visit will be decided by the participant and his or~          her rheumatologist. Participants may take any recommended medicine, including the TNF~          inhibitor they had been taking before the study. They will also receive a questionnaire~          to complete at home and mail back before the final study visit.~        -  At the final visit (week 100), participants will repeat the tests and imaging studies~          from the second and sixth visits.~   "
96537|NCT01793506|"~     The purpose of this study is to evaluate a novel screening test to detect patients with~     primary immunodeficiencies(PIDs). The investigators plan to use information gained from this~     study in order to advance the field of clinical immunology, thus improving the diagnosis,~     treatment, and well-being of future patients. The purpose of this study is to determine if~     this screening test is able to detect patients with immune problems, and the investigators~     will test patients with known PIDs to determine if the test is accurate~      The investigators hypothesize that detecting serum immunoglobulins from dried blood spots~     will be effective in detecting patients with known primary immunodeficiencies. If our~     hypothesis is confirmed, it opens the possibility of using point of care testing to screen~     for primary immune deficiencies.~      Age of study subjects will range from 1 year to 80 years of age, and will be recruited form~     the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of~     Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is~     eligible for this study. This will include patients with known PIDs as well as patients~     evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be~     analyzed over a two year period.~   "
96539|NCT01793480|"~     This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the~     clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in~     patients with inadequate pain relief or intolerable side effects when treated with level 3~     opioid.~      Principal objective is to compare the clinical effects (success/failure) of two methods of~     methadone titration in patients with cancer-related pain inadequately relieved or with~     intolerable side effects after treatment with level 3 opioid.~      Secondary objectives are : Overall safety of methadone during the study, to describe the~     patients' characteristics, to describe the effects of methadone on pain relief, to describe~     the methadone administration, to evaluate patient's quality of life, to evaluate the~     prescriber's opinion regarding the handling of methadone initiation.~   "
96540|NCT01793467|"~     Raltegravir (RAL) is a preferred option for initial antiretroviral therapy in the most~     recent HIV Treatment Guidelines and is emerging as a popular choice for use in the~     specialized population of HIV-infected patients being considered for solid organ~     transplantation. Data from HIV-infected persons with normal organ function have revealed few~     raltegravir-associated metabolic complications compared to older antiretrovirals, and in~     general, drug-drug interactions with raltegravir are infrequent. The absence of such~     concerns appears to make raltegravir a potentially appealing option for antiretroviral~     therapy in HIV-infected patients being considered for solid organ transplantation.~      At present, however, little is known of the safety and long term tolerability of~     RAL-containing regimens in persons undergoing solid organ transplantation. As more~     HIV-infected patients undergo organ transplantation, there is a growing need for good data~     on such things as the effect of dialysis on RAL concentrations, the potential interactions~     with commonly used immunosuppressive drugs, and the pharmacokinetic (PK) /pharmacodynamic~     (PD) characteristics in those with end stage organ failure, as well as those with~     functioning grafts.~      The proposed study will also examine transplant function and survival in HIV-infected~     patients receiving RAL-containing ART and will compare it to HIV negative historic controls.~   "
96541|NCT01793454|"~     Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative~     stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality,~     preanesthetic and postanesthetic expiration tidal volumes.~   "
96542|NCT01793441|"~     This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of~     concept study will investigate the efficacy and safety of RG7314 in adult participants with~     ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral~     doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety~     review, the study may proceed to Stage II. In Stage II of the study, additional participants~     will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12~     weeks. After an independent safety review, Stage III will be started wherein additional~     participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or~     placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review~     twice and if no safety signal is observed, then additional participants will be randomized~     in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or~     placebo for 12 weeks in Stage IV.~   "
96543|NCT01793428|"~     13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion~     of six or more units of packed Red Blood Cells. It is currently difficult to predict the~     need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue)~     and blood pressure can be normal during the first hours despite intensive bleeding.~      It's well known that blood or arterial lactate measures correlate with trauma severity but~     these measures are not available in a pre-hospital setting. The investigators want to test~     whether capillary lactate measures also correlate with trauma severity and can therefore~     predicts earlier transfusion needs.~   "
96544|NCT01793415|"~     Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS~     experience overwhelming fatigue and a host of other symptoms that are not improved by bed~     rest. Interestingly, many of the symptoms experienced by people with CFS are identical to~     symptoms caused by long-term low-level exposure to mercury, which is called~     micromercurialism.~      This study will examine if the mercury binding substance IodoCarb(r) can improve the health~     of patients with CFS.~   "
96545|NCT01793402|"~     Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of~     vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics~     recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of~     vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D.~     This study assesses vitamin D status at birth and during hospital stay in infants delivered~     delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake~     relative to the target set by the American Academy of Pediatrics for children.~   "
96546|NCT01793389|"~     The present study deals with treatment of localized gingival recessions. The hypothesis of~     this study is that platelet rich fibrin can be used an alternative to subepithelial~     connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will~     prove to be similarly effective as subepithelial connective tissue graft, it will be~     possible to avoid a donor site and to decrease patient discomfort after operation.~   "
96547|NCT01793376|"~     Hypothesis This study is designed as an integral part of the development of a new CE score~     for Crohn's disease.~      The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated~     CD score for SB involvement. In order to expand this score to the colon, this study will aim~     to develop the colonic score and later on will be combined with the already established SB~     score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a~     retrospective study in which up to 30 videos of colon Crohn's disease subjects who have~     undergone the Colon 2 CE procedure will be evaluated.~      These cases will have evidence of large and / or small bowel Crohn's disease The chosen~     videos will be marked for CD lesions by the site The de-identified marked videos will be~     scored by 4 independent experienced endoscopists, blinded to the results of the standard~     workup procedures, according to the colonic and CECDAIic new scores~   "
96548|NCT01793363|"~     Prospective, interventional multicentric study in ICU during weaning from mechanical~     ventilation in tracheotomized patients~   "
96549|NCT01793350|"~     A combined Phase 1 & 2 study to evaluate the safety and effectiveness of a new diabetic~     neuropathy topical cream, containing benfotiamine, will be performed at 5 clinical sites and~     plans for BC-DN-01 administration in up to 135 volunteer patients using a standard Phase 1 +~     2 design. Up to 15 subjects will receive BC-DN-01 in Study Phase 1 and up to 120 subjects~     will receive BC-DN-01 or placebo in Study Phase 2.~      In Phase 1, a BC-DN-01 dose delivering 160mg benfotiamine/day (80mg twice daily) will be~     administered for the first 7 days. On visit day 0, patients will commence study treatment.~     Patients will be interviewed by phone on day 3 and return to clinic on day 7 for safety~     assessments. If the drug is well-tolerated and no significant adverse events experienced,~     the total daily BC-DN-01 dose will be increased on days 7-14 to 320mg benfotiamine/day~     (160mg b.i.d.). Patients will be interviewed by telephone on day 10 and return to clinic on~     day 14 for safety assessments.~      Once the safety profile has been determined in Phase 1 as acceptable, the Phase 2 study will~     be initiated to evaluate clinical efficacy of BC-DN-01. Phase 2 is a randomized,~     placebo-controlled, double-blind, parallel study. Participants receive placebo or BC-DN-01~     based on 1:1 randomization. Each patient will apply 4g of the study medication to each leg~     twice-a-day administering 320mg benfotiamine dose/day for 12 weeks.~      Participants will be evaluated in the clinic at baseline and at 4, 8, and 12-week time~     points; study staff will interview the patients by telephone on weeks 2, 6, and 10.~      The primary endpoint of the phase 2 trial is reduction in DPN pain measured by the Brief~     Pain Inventory. Phase 2 patients will be invited to give written consent to take part in~     biopsy sampling and additional gene expression analysis.~   "
96550|NCT01793337|"~     Accurate measurement of core body temperature at the scene of an accident is critical for~     both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the~     lower third of the oesophagus is considered the gold standard of CT reading, but invasive~     and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading~     have been widely tested by may be unreliable in extreme environmental temperatures.~     Similarly, the Double Sensor device is a non-invasive device and is promising for~     prehospital use but has not been sufficiently verified under very cold and hot environmental~     conditions. Furthermore, comparisons of different non-invasive methods with oesophageal~     measurement in extreme conditions are lacking. The objective of these studies is to compare~     different techniques of core body temperature measurement with exposure to cold and hot~     environments.~   "
96551|NCT01793324|"~     A study to evaluate the effectiveness of an update of educational materials with respect to~     evaluation of monitoring of metabolic parameters~   "
96552|NCT01793311|"~     The goal of the study is to determine the effect of different doses of caffeine on~     intraocular pressure. We hypothesized that higher dosage of caffeine would increase~     intraocular pressure more than lower doses.~      Eligible subjects will be randomized into three groups:~        1. group 1: intake of decaffeinated coffee~        2. group 2: intake of coffee with lower caffeine dose~        3. group 3: intake of coffee with higher caffeine dose~      Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.~   "
96553|NCT01793298|"~     The purpose of this study is to evaluate the safety and tolerability of the dry powder~     formulation of ASM-024 following single and multiple administration by inhalation of~     ascending doses in healthy subjects and subjects with stable moderate asthma.~   "
96554|NCT01793285|"~     Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg~     improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid~     arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period,~     we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing~     the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100~     mg/week) in subjects with AS refractory to conventional therapy. The interim results of said~     study do not appear to support the value of doubling the dose of etanercept in the treatment~     of subjects with AS. Once this study was finalised, the subjects continued to be monitored~     by their regular physician, who decided on the dose and treatment to follow according to the~     conditions of standard clinical practice.~      The objective of this observational study is to evaluate the course of the disease in the~     long-term (three years) under the conditions of standard clinical practice, in subjects who~     had participated in the LoadET study. Therefore, we would like to follow-up on those~     patients by reviewing their clinical histories for the three-year period between the~     finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will~     allow us to assess the efficacy and survival of the drug, as well as the possible appearance~     of side effects in the three years following the finalisation of the study by comparing the~     results according to if the subjects had received 50 mg/week or 100 mg/week during the~     LoadET study (0881A3 102090).~   "
96555|NCT01793272|"~     To evaluate the effect of pentoxifylline used in preparation of semen samples that will be~     used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e.~     cases which does not need motility enhancement prior to ICSI) in comparison to semen samples~     without pentoxifylline preparation on the outcome of ICSI.~   "
96556|NCT01793259|"~     The primary objective of this study is to assess the number of patients preferring the~     methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of~     treatment based on a questionnaire~   "
96557|NCT01793246|"~     Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung~     lesions or for detection of acute rejection following lung transplants. The hypothesis is~     that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or~     incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.~   "
96558|NCT01793233|"~     This clinical trial studies blood sample markers of reproductive hormones in assessing~     ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of~     blood from patients with cancer in the laboratory may help measure the effect of curative~     therapy for lymphoma on ovarian failure.~   "
96566|NCT01793129|"~     This study is a randomized, controlled trial to assess safety and effectiveness of whole~     body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who~     present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The~     study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and~     randomly assign them to either receive hypothermia or participate in a non-cooled control~     group.~   "
96559|NCT01793220|"~     The aim of this research is to find out if mobile phone text message reminders of~     appointments can help to address missed appointments in Psychosis Community Services.~     Another aim is to examine if fewer missed appointments result in clinical benefits for~     service users and in lower costs for Psychosis Community Services over a period of 6 months.~     600 users from 2 London Psychosis Community Services will take part in this research. Each~     participant will be put into one of two groups, as s/he joins the study: In the first~     (experimental) group, each participant will receive appointment reminders for 6 months (7~     and 1 day/s before each appointment), starting with the first available opportunity upon~     joining the study. In the second (control) group, each participant will not receive~     appointment reminders for 6 months. The choice of group for each individual will be made at~     random by a computer. Clinical information will be collected for 6 months from the time each~     participant joins the study, using, with his or her consent, their anonymised electronic~     medical records. The following clinical information will be compared between the~     experimental and control groups: Attendance of appointments, number of inpatient admissions,~     number of days in inpatient care, number of inpatient admissions under the mental health~     treatment act, number of referrals to a home treatment team, number of times patient has~     changed medication, health and social functioning. Service use, service costs and the~     cost-effectiveness of the reminder system will also be examined. Towards the end of their~     participation, service users, as well as mental health professionals, will be invited to~     express their views, concerns and suggestions in relation to the reminder service by~     completing a brief anonymised (service users) or anonymous (staff) questionnaire~   "
96560|NCT01793207|"~     The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of~     cancer-related deaths related to CRC is also rising to an alarming level. This picture is~     similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually,~     moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much~     younger patients than their counterparts worldwide. Fortunately, the early detection of CRC~     and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality~     related to this tumor, this has prompted the development of robust screening programs for~     CRC in several western countries. The implementation of a CRC screening program in Egypt has~     been hampered by the low compliance of the patients and the relatively high cost of~     colonoscopy. There is a need for an affordable, non-invasive, simple, accurate and socially~     accepted screening test to allow such a program to succeed in Egypt. Recent studies have~     shown that DNA is the future target of screening tests for several malignancies.~     Particularly for CRC a few preliminary studies have shown encouraging results with separate~     DNA methylation markers both in blood and stool. In our efforts to develop a screening test~     with the criteria stated above, the investigators have decided to join the forces of 2 of~     the largest medical centers in Egypt and the middle-east: Kasr-Alaini hospital and the~     National cancer institute (NCI). The investigators plan to test a panel of 7 DNA methylation~     markers in peripheral blood for their performance as an early marker for CRC and colorectal~     adenomas. Data from this study will pave the way for the development of a screening test for~     CRC tailored to the Egyptian population, moreover, it will supply essential data about the~     genetic alterations occurring in CRC in Egyptian patients.~   "
96561|NCT01793194|"~     Problem: Approximately 4 million live births occur in the United States each year. Pregnancy~     causes many physical changes in the mother, including venous distension, increased ability~     to form blood clots, and hormonal changes. Data suggest that these factors help cause venous~     insufficiency (when the veins do not adequately return blood from the extremities to the~     torso). As venous insufficiency progresses, complications follow, the most severe of which~     include superficial thrombophlebitis and deep venous thrombosis (DVT, or blood clots).~     Although the fear of DVT has been well publicized, its prevention and prevalence in pregnant~     women has not been well-studied.~      The exact cause of venous insufficiency is not known. However, known risk factors include~     being female and hormonal changes associated with oral contraceptive use, certain hormone~     replacement medications, and pregnancy. Being pregnant places the mother at additional risk~     for developing venous insufficiency.~      Compression stockings are used to manage the condition, but this is by no means standard of~     care despite their easy use and safety. The medical community's understanding of how~     compression stockings work is largely theoretical; however, it is believed that the~     compression works by preventing venous hypertension in the lower legs, thereby preventing~     venous insufficiency and its associated complications.~      Research hypothesis: The investigators hypothesize that compression stocking use will be~     associated with lower incidence of varicose veins and, in those patients who already have~     varicose veins, lower incidence of complications associated with venous insufficiency.~     Further, the investigators believe that compression stocking use will be associated with a~     lower incidence or lessening of symptoms associated with venous insufficiency.~      Importance: An undetected DVT can be fatal. Even if detected promptly, DVT is associated~     with long term health problems. Treatment of a DVT requires anticoagulation which can be~     risky to both mother and fetus. The prevention or reduction of DVT in pregnant women through~     use of compression stockings would revolutionize their care. Further, this intervention is~     safe and noninvasive.~      The investigators propose to conduct a randomized, pilot study comparing pregnant women~     without and with varicose veins randomized to wear compression stockings to a similar group~     of participants randomized to no compression stocking use.~   "
96562|NCT01793181|"~     Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown~     that the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have~     shown a possible link between sun exposure and venous thrombosis. Vitamin D levels have been~     shown to have a similar seasonal variation, with a peak occurring in the summer. The primary~     source of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin~     and converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via~     previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to~     synthesize vitamin D at sufficient levels in winter and the exposure time required to reach~     a standard dose is impractical from at least October through March.~      The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion~     (CRVO) patients and compare them with the vitamin D levels in randomly selected control~     patients matched for age and month of disease onset. This is to evaluate whether vitamin D~     deficiency may be a risk factor in the onset of CRVO.~      The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than~     matched controls.~   "
96563|NCT01793168|"~     CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in~     Sioux Falls, South Dakota. It provides researchers with a centralized, international patient~     registry for all rare diseases. This program allows patients and researchers to connect as~     easily as possible to help advance treatments and cures for rare diseases. The CoRDS team~     works with patient advocacy groups, individuals and researchers to help in the advancement~     of research in over 7,000 rare diseases. The registry is free for patients to enroll and~     researchers to access. Visit sanfordresearch.org/CoRDS to enroll.~   "
96564|NCT01793155|"~     The purpose of this study is to evaluate the effects of postoperative inspiratory muscle~     training on the recovery of respiratory muscle strength in high risk patients referred for~     lung cancer surgery. Furthermore, to assess longitudinal changes in respiratory muscle~     strength, physical capacity and health-related quality of life after lung cancer surgery~   "
96565|NCT01793142|"~     This survey is conducted for preparing application material for re examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and~     efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation~     for New Drugs~   "
96567|NCT01793116|"~     This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age,~     in NICHD Neonatal Research Network (NRN) centers. The registry collects observational~     baseline data on both mothers and infants, and the therapies used and outcomes of the~     infants. The information collected is not specific to a disease or treatment (i.e., it is~     generic). Data are analyzed to find associations and trends between baseline information,~     treatments, and infant outcome, and to develop future NRN trials.~   "
96568|NCT01793103|"~     The goal of the present study is to establish a prospective observational cohort of~     Rheumatoid Arthritis patients in order to~        1. Determine and validate biomarkers that predict drug response and toxicity in RA.~        2. Determine and validate biomarkers that predict disease activity and prognosis in RA.~        3. Evaluate the natural history of treated RA in terms of its clinical, functional and~          economic outcomes.~   "
96569|NCT01793090|"~     The aim of the research is to investigate the safety and efficacy of EPI-743 treatment in~     patients with Cbl-C defect and related visual and neurological impairment. Primary Endpoints~     will be the improvement in visual function as assessed by visual acuity and eye-hand~     coordination and manual dexterity. Secondary Endpoints will be the improvement in neurologic~     function, evaluated by a battery of age-appropriated psychophysical tests, and/or in~     objective electrophysiological tests such as Visual Evoked potentials (VEP) and~     Electroretinogram (ERG) and/or the change in serum markers of redox state.~   "
96570|NCT01793077|"~     Tremodi is an observational, non-interventional, prospective, open-label, non-comparative~     study that will collect real life data of a treatment with Depo-Eligard® in 3 different~     administrations in male prostate cancer patients.~      Once the examining physician has decided on the therapeutic approach and if the selection~     criteria are fulfilled, he will propose the patient to participate in the study. An informed~     consent form will be collected for all participants in the study.~      There are 2 possible study visits that coincide with a routine consultation, namely visit 1~     (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions~     (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to~     complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining~     physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the~     treatment benefit of the patient.~      Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both~     visits, if available.~   "
96571|NCT01793064|"~     The purpose of this study is to develop and evaluate an adaptive shaping intervention based~     on Behavioral Economics and Operant principles to promote physical activity behaviors~     (adaptive group) and compare to a static physical activity intervention (static group) using~     a two-group randomized controlled trial design. Participants will include 20 overweight men~     and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following~     components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational~     materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial~     incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback~     based on percentiles and a moving window of their recent physical activity, with~     incentives linked to goal attainment. Comparison intervention participants will receive the~     static 10,000 steps per day goal, with matching incentive amounts but without incentives~     linked to goal attainment. The study will compare differences in goal setting and shaping~     procedures that aim to increase physical activity behavior.~      Primary aims include:~        1. To determine whether physical activity (pedometer-measured steps/day) in both the~          Adaptive and Static interventions increased compared to their respective baselines.~          Hypothesis: Both the adaptive and static interventions will result in increased~          physical activity over 6 months.~        2. To evaluate whether the Adaptive Intervention results in greater change in physical~          activity (pedometer-measured steps/day) compared to the Static Intervention.~          Hypothesis: The adaptive intervention will result in significantly greater physical~          activity, measured by pedometer, compared to the static intervention over 6 months.~        3. To assess participants' satisfaction with the overall program. Hypothesis: Adaptive~          Intervention participants will report greater overall satisfaction with the~          intervention than the Static Intervention participants.~   "
96572|NCT01793051|"~     The goal of this clinical research study is to learn if minocycline can help reduce the~     symptoms reported by patients with MM who receive therapy with lenalidomide.~      Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine~     production, which may help to reduce multiple symptoms.~   "
96573|NCT01793038|"~     Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent~     periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the~     standard first drug of treatment for ovulation induction. Ovulation and conception will~     occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in~     response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.~   "
96574|NCT01793025|"~     The purpose of this study is to assess the safety and efficacy of infusing immune cells from~     a donor as treatment for patients with acute myeloid leukemia that is resistant to~     chemotherapy or who have experienced relapse. Unlike standard bone marrow or stem cell~     transplantation which uses donors who are well 'matched' to the patient, this study uses~     donors whose immune cells are not compatible with the patient. With standard stem cell or~     bone marrow transplantation, the well-matched immune cells will attack the leukemia but they~     also attack the patient's organs (a situation called graft-versus-host disease, which can~     persist in the long term). Our hypothesis is that the mismatched donor cells will fight the~     leukemia but will then be eliminated from the patient's body, so long-term side effects like~     graft-versus-host disease should not occur.~   "
96575|NCT01793012|"~     Infections are critical factors for the survival of critically ill patients. A broad,~     high-dose and early initial therapy of antibiotics is of particular relevance.~      A serious problem is the high variability of antibiotic serum concentrations after~     administration of antibiotics in patients of the critical care units. This may result in the~     risk of underdosage with possible ineffective therapeutic levels as well as in the risk of~     overdosage with possible adverse and toxic effects. The goal of this study is to determine~     antibiotic concentrations in blood and to evaluate concentrations with the course of the~     therapy. The measurement of antibiotic concentrations in blood may allow an individual~     adaption of the dose in future.~      100 - 200 patients will be included in this study. Only critically ill patients of the ICU~     of the Department of Anaesthesiology will be included that receive one or more of the~     following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin,~     linezolid, and colistin.~   "
96576|NCT01792986|"~     This study will determine whether an intensive fasting protocol alters hemoglobin A1c~     measurements or other markers of metabolic and cardiovascular risk by performing a 5-week~     clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is~     controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour~     water-only fasting, including at baseline and at the end of the week for each week of the~     study (a total of 6 24-hour fasts).~   "
96577|NCT01792973|"~     HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort~     study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort~     of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the~     prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical~     lesion. The study will also provide the distribution of the HPV genotypes involved as well~     as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals,~     older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed~     to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV~     testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection~     receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is~     provided according to the National Guidelines.~   "
96578|NCT01792960|"~     Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence~     of gene mutations in Korean patients with familial hypertrophic cardiomyopathy~   "
96579|NCT01792947|"~     Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve~     terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal~     nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.~      The aim of this study was to evaluate the effect of percutaneous electroneurostimulation~     (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.~   "
96580|NCT01792934|"~     The purpose of this study is to compare overall survival rates of colorectal cancer patients~     with multi-organ metastases with an indication for first line systemic treatment randomized~     for treatment with combination chemotherapy or treatment with combination chemotherapy and~     additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE~     and SBRT, depending on best clinical judgement according to a standardized treatment~     algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment~     with chemotherapy and biologicals will provide an improvement in progression free and~     overall survival in this patient group.~   "
96581|NCT01792921|"~     Scientific Rationale: Many children with ADHD have serious difficulties in participation in~     daily occupations in their ecological settings. These difficulties have a pervasive negative~     impact on their everyday functioning and quality of life (QoL). Although pharmacological~     treatment has been proven effective in treating ADHD symptoms in many children, as have~     psychosocial interventions such as parent training, there is little evidence for integrative~     approaches that address the cognitive, volitional and social-environmental barriers to~     participation with this population. Although preliminary positive effects of a~     cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been~     demonstrated, additional evidence is needed to confirm these initial findings. Methods:~     Initial results of our pilot study (N=17 children with ADHD) demonstrated significant~     moderate to large effects of Cog-Fun treatment, which targeted participation and executive~     functions in daily life. Significant effects were also found for a measure of self-efficacy~     and neuropsychological measures of attention, planning and organization. Parent ratings~     showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current~     study is to replicate the pilot study findings in a randomized controlled trial. The study~     will be a randomized controlled trial with a crossover design, including 2 groups of~     children with ADHD attending elementary school and their parents. The research group (Group~     A, n=50) will receive three months of the Cog-Fun treatment, designed for a parent/child~     dyad and the control group (Group B, n=50) will be wait-listed and receive treatment after~     three months. Outcomes will include measures of participation, executive functions in daily~     life, child and parental self-efficacy, ADHD symptoms and QoL. The investigators expect to~     find a significant main effect of time (pre-post intervention), group (research vs. control)~     and a significant interaction effect (group x time) on executive and occupational outcome~     measures.~   "
96582|NCT01792908|"~     The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase~     protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy~     volunteers immediately after its application and 48 hours later.~   "
96583|NCT01792895|"~     The purpose of this study was to investigate the comparative effectiveness of high velocity~     and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT)~     in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate~     effects in range of motion and pain thresholds, and the interaction between psychological~     factors and the outcomes of these three types of manual therapy.~      The hypothesis is that all manual therapies techniques will produce similar effects.~   "
96584|NCT01792882|"~     The study is intended to collect specimens to support the application of genome analysis~     technologies, including large-scale genome sequencing. This study will ultimately provide~     cancer researchers with specimens that they can use to develop comprehensive catalogs of~     genomic information on at least 50 types of human cancer. The study will create a resource~     available to the worldwide research community that could be used to identify and accelerate~     the development of new diagnostic and prognostic markers, new targets for pharmaceutical~     interventions, and new cancer prevention and treatment strategies. This study will be a~     competitive enrollment study conducted at multiple institutions.~   "
96585|NCT01792856|"~     Jockey Club Early Psychosis (JCEP) project is a territory-wide specialized EI service that~     is launched in August 2009 and provides 3-year phase-specific intervention for adult~     patients presenting with first-episode psychosis (FEP) to psychiatric units of Hospital~     Authority (HA). To promote early functional recovery, JCEP project develops~     recovery-oriented intervention based on life coaching approach (recovery-oriented coaching)~     in addition to case management. This is a structured group-based coaching program~     incorporating cognitive-behavioural and solution-focused therapeutic components. The program~     facilitates patients to undergo active change process via identification of achievable~     goals, formulation of action plans, provision of feedback and progress monitoring for goal~     attainment. Subjects will be randomized (block size: 2) to receive either recovery-oriented~     coaching program (intervention group) or supportive therapy (control group).~      Intervention group Subjects are scheduled to receive a 6-month group-based recovery-oriented~     coaching program. This is a structured, manualised treatment program based on life coaching~     principles with cognitive-behavioural and solution-focused elements incorporated. It guides~     subjects to undergo an active, yet stepwise change process by stimulating motivation,~     setting achievable goals, generation of action plans via collaborative exploration,~     fostering self-regulatory capacity, and provision of autonomy-supportive treatment~     environment and peer support. Subjects' perceived competence, sense of control,~     self-management skills and hence functioning will be improved via successful experiences and~     positive feelings generated after attainment of self-initiated goals. Cognitive-behavioural~     techniques such as self-monitoring, activity scheduling and behavioural modification will be~     employed.~      Control group Subjects will receive group-based supportive therapy provided by case managers~     of JCEP project. The therapy provides patients with psychoeducation about psychosis, stress~     management, emotional and social support. Coaching and cognitive-behavioural techniques will~     not be incorporated. Therapy sessions and duration will be comparable to that of~     recovery-oriented coaching program.~      Assessments Each subject will be assessed at three time points, i.e., baseline before~     randomization (T1), 12 weeks (T2, post-phase I intervention) and 24 weeks (T3, post-phase II~     intervention). Assessments on symptomatology, functioning and subjective wellbeing will be~     administered at all time points. Cognitive and reinforcement learning assessments will be~     conducted at T1 and T3. functional magnetic resonance imaging (fMRI) will be performed at T1~     and T3 for the first 20 subjects recruited in each treatment group. A group of healthy~     volunteers matched in sex, age and educational level will be recruited from the community~     with fMRI, cognitive and reinforcement learning evaluations done at T1 and T3. To maintain~     blinding to treatment assignment, assessments will be conducted by research assistants who~     are independent of treatment delivery and randomization. Subjects will be trained to not~     reveal their treatment allocation before each follow-up assessment.~   "
96586|NCT01792843|"~     -  a data driven approach has identified different cognitive phenotypes in Parkinson's~          disease (PD)~        -  this heterogeneity possibly reflects the diversity of the neuronal damage caused by the~          disease~        -  we hypothesize that the different clinical presentations are associated to specific~          anatomical and functional correlates~   "
96587|NCT01792830|"~     Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while~     they are in the hospital. No studies have shown what the best insulin regimen is for CABG~     patients with type 2 diabetes is after going home from the hospital. Patients with high~     blood sugar and diabetes after cardiac bypass surgery will be followed for 3 months to look~     at how well their treatment(s) for diabetes work after discharge. Patients with diabetes~     will be discharged on oral antidiabetic drugs or with insulin glargine injections based on~     their sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the~     average blood sugar level in the body over 3 months) will be discharged on the same diabetes~     medications that they used before coming to the hospital. Those with an HbA1c between 7% and~     9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and~     oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100%~     of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin~     glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12~     weeks after discharge.~   "
96588|NCT01792817|"~     Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of~     non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of~     cluster headache. The study compares the safety and effectiveness of an active treatment~     (GammaCore) against a sham treatment.~   "
96589|NCT01792804|"~     Increasing resistance to antibiotic agents has been recognized as a major health problem~     worldwide that will even aggravate due to the lack of new antimicrobial agents within the~     next decade [1]. This threat underscores the need to maximize clinical utility of existing~     antibiotics, through more rational prescription, e.g. optimizing duration of treatment.~      Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000~     cases occurring annually in Europe [2]. A course of at least 14 days of intravenous~     antimicrobials is considered standard therapy [3-5] in uncomplicated SAB. This relatively~     long course serves to prevent SAB-related complications (such as endocarditis and vertebral~     osteomyelitis) that may result from hematogenous dissemination to distant sites. However,~     there is insufficient evidence that a full course of intravenous antibiotic therapy is~     always required in patients with a low risk of SAB-related complications.~      In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an~     early switch from intravenous to oral antimicrobial therapy is non-inferior to a~     conventional 14-days course of intravenous therapy regarding efficacy and safety. An early~     switch from intravenous to oral therapy would provide several benefits such as earlier~     discharge, fewer adverse reactions associated with intravenous therapy, increased quality of~     life, and cost savings.~   "
96590|NCT01792791|"~     Arthritis is the nation's most common cause of disability. An estimated 50 million U.S.~     adults (about 1 in 5) report doctor-diagnosed arthritis. Twenty three million U.S. adults of~     working age (18-64 years) have arthritis; and in this age group arthritis-attributable work~     limitations affect about 1 in 3 people. An estimated 12% of all patients seeking~     intervention for symptomatic arthritis have an etiology of previous trauma to the involved~     joint.~      The purpose of this study is to examine these inflammatory compounds in the joint fluid~     (synovial fluid), the joint lining (synovium), and in blood among subjects with isolated~     intra-articular fractures.~      The hypothesis is that early levels of intra-articular inflammation and markers of joint~     tissue degeneration following articular fracture in the human knee are predictive of the~     development of PTA (Post Traumatic Arthritis). Early levels of intra-articular inflammation~     and markers of joint tissue degeneration identified from human knee joints following~     articular injury are predictive of the development of PTA in the mouse knee.~      Samples of blood, urine and synovial fluid will be taken at the spanning frame surgery and~     only synovial fluid at the ORIF (Open Reduction Internal Fixation)surgery. Two MRIs~     (Magnetic Resonance Imaging) will be part of this study at 4 weeks and 18~     months.Participants will complete a set of questionnaires(KOOS: Knee Injury and~     Osteoarthritis Outcome Score) at 4 weeks and 18 months.~   "
96591|NCT01792778|"~     The purpose of this pilot study is to collect the necessary information for determining the~     appropriate sample size of a statistically powered trial comparing the performance of two~     different blood control peripheral intravenous catheters.~   "
96592|NCT01792765|"~     Kidney stones are very common, and can inflict a significant degree of pain and renal~     damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In~     order to remove these stones, an Urologist and their team use fluoroscopic guidance to do~     so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to~     the patient, as well as the health care team, which has been shown to have serious health~     consequences. Previous studies have shown that in certain populations, like pregnant women,~     stones can be managed using ultrasound guidance. The investigators propose that mid and~     distal ureteral stones could be managed using ultrasound guidance in conjunction with~     conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent~     placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and~     patients.~      The investigators hypothesize that distal ureteral stones can be identified and efficiently~     fragmented and removed under ultrasound guidance in a safe and effective manner without the~     use of radiation.~   "
96593|NCT01792752|"~     The overall goal of this project is to implement and evaluate a community-level, structured~     approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico.~     The Enhanced HIV Care Access and Retention Intervention will: 1) identify drug users~     living with HIV who either do not know their HIV status and/or are not engaged in HIV care;~     2) provide direct HIV care services through a mobile health van; and 3) support identified~     HIV-infected drug users with patient navigators to enhance their ability to engage in HIV~     care and substance abuse treatment, to initiate antiretroviral therapy, and maintain~     adherence to their treatment regimens. The structural enhanced care approach will be~     evaluated through a randomized roll-out design, a refinement of the stepped-wedge design.~     The community-level success of the intervention will be assessed by evaluating virologic~     suppression (primary biological outcome), increased attendance to HIV care visits, uptake of~     antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as~     secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn~     from each of the neighborhoods included in the intervention. We will also evaluate the~     implementation process and cost of the enhanced care approach including implications for~     cost-effectiveness, feasibility of expansion, and sustainability.~   "
96594|NCT01792739|"~     The purpose of this trial is to clarify the impact of lactobacillus preparation on the~     incidence of diarrhea in ICU-admitted patients.~      Almost all patients in ICU are treated with antibiotics for the effective control of various~     infections. However, antibiotics-associated diarrhea is another matter of concern. Many~     previous studies were proved that the use of probiotic lactobacillus preparation can reduce~     antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to~     perform a similar study in severely ill patients in ICU.~   "
96595|NCT01792726|"~     TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis~     that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy~     (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost~     (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic~     trial in which each participating centre can use the local predefined inclusion/exclusion~     criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss)~     are eligible to enter patients into the trial.~      Eligible patients are those with a higher risk of local recurrence after breast conserving~     surgery.~      After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All~     patients will receive whole breast EBRT. They may receive any other adjuvant treatments as~     deemed necessary. The protocol recommends that patients be followed at six monthly intervals~     for three years and then annually.~      The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are~     relapse-free survival, site of recurrence, overall survival (breast-cancer specific and~     non-breast cancer deaths) patient satisfaction and quality of life.~   "
96596|NCT01792713|"~     Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients~     with skin alterations associated with atopic dermatitis~   "
96597|NCT01792700|"~     patients who had failed previous H. pylori eradication on standard triple therapy were~     randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate~     bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)~     (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000~     mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests~     were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO~     test, and culture). In patients who maintained continuous H. pylori negativity for the first~     year after eradication therapy, H. pylori status was assessed every year. For the evaluation~     of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic~     gastritis or intestinal metaplasia were analyzed.~   "
96598|NCT01792687|"~     This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone~     acetate and prednisone in patients with metastatic castration-resistant prostate cancer.~   "
96599|NCT01792674|"~     Care for pregnant is a field where unexpected emergencies occur, however emergencies are~     rare and hence competences difficult to learn. Therefore, it can be relevant to use~     simulation-based medical education. Many questions on how simulation can optimise learning~     remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e.~     in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or~     simulation center) impact learning.~      Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on~     learning outcome, safety-attitudes, team performance and clinical performance in the~     simulated setting plus stress and motivational inducing effect of simulation settings.~      Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes:~     Safety Attitudes Questionnaire, team- and clinical performance score, validated stress~     inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on~     perceptions of the simulation and organisational changes needed.~      Perspective: To provide new knowledge on contextual effects of different simulation~     settings.~   "
96600|NCT01792661|"~     The study's purpose is to address the challenges of providing stage-appropriate chronic~     kidney disease (CKD) education and care by developing innovative programs using a CKD~     Patient Navigator system and an EHR (electronic health record)-based enhanced electronic~     communication system specific for a CKD patient and her/his physicians/caregivers. The~     investigators plan a randomized controlled trial of these innovations to examine the utility~     and effectiveness of these special interventions.~      The investigators' CKD registry aids in identifying patients for recruitment for the~     randomized control trial. Patients are randomized into one of four groups. The four groups~     are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR)~     included in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals~     of care and CKD education; 3) the patient navigator, a lay professional trained in the~     specifics of chronic kidney disease navigation with a focus on the needs of their patients~     based on the National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient~     navigator combined with the enhanced MyChart.~      The investigators hypothesize that a CKD Patient Navigator program will develop a more~     prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a~     more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced~     PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than~     usual care.~      The results of this study will lay the foundation for a larger multi-center national~     clinical trial that will build upon the feasibility and knowledge gained from this planning~     grant.~   "
96612|NCT01792505|"~     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis~     carries with it a median survival of approximately 24 months. The current standard treatment~     of surgical resection followed by radiation therapy and chemotherapy has not substantially~     prolonged survival and even the few treatment options shown to exhibit small increases in~     survival primarily benefit certain (i.e., young) patient subpopulations.~      Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body~     to recognize the tumor cells are foreign and produce its own response to fight off recurring~     tumor cells. A promising means of causing an immune response so the body can create this~     immunity is through the use of dendritic cell (DC) vaccines.~   "
96613|NCT01792492|"~     This study will investigate the usefulness of an optical probe in the differentiation of~     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.~   "
96614|NCT01792479|"~     The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients~     with advanced non-small cell lung cancer (NSCLC).~   "
96601|NCT01792648|"~     Metabolic syndrome includes a cluster of cardiovascular disease (CVD) risk factors including~     insulin resistance, abdominal obesity, high blood pressure and an atherogenic lipoprotein~     phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels~     of small LDL particles. While lifestyle intervention remains the cornerstone for its~     management, the optimal dietary macronutrient distribution for improving blood lipids and~     CVD risk remains a topic of controversy. While both low carbohydrate diets and weight~     reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low,~     and it becomes imperative to identify alternative dietary approaches.~      Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that~     predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has~     been demonstrated in patients with diabetes, there have been no trials in non-diabetic~     patients with metabolic syndrome. Moreover, there is limited information of the effects of~     almond intake on LDL particle subclasses.~      The overall objective of the present study is to determine whether lipoprotein measures of~     CVD risk in individuals with the metabolic syndrome are reduced by almond supplementation in~     a diet with overall macronutrient content that conforms to current guidelines. Our main~     hypothesis is that in these individuals, almond consumption can reduce levels of small and~     medium LDL particles without the need to restrict dietary carbohydrates to levels below~     those currently recommended.~      This hypothesis will be tested by comparing the lipoprotein effects of an~     almond-supplemented diet (20%E) with those of two reference diets that do not contain almond~     products: one with similar content of carbohydrate, protein, and fat (standard reference),~     and the other in which carbohydrate content is reduced by substitution of protein and~     monounsaturated fat (low-carbohydrate reference).~      We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40~     individuals with atherogenic dyslipidemia of the metabolic syndrome. We will test whether~     the almond supplemented diet will result in lower levels of lipoprotein measures of CVD~     risk, specifically LDL-C and small and medium LDL particles, compared to either the standard~     or low-carbohydrate reference diets.~   "
96602|NCT01792635|"~     This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of~     oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.~   "
96603|NCT01792622|"~     Develop a brief, new, patient reported outcome instrument that is valid for use in clinical~     practice and clinical trials.~   "
96604|NCT01792609|"~     Objectives Primary objective: Determine if there is a clinically significant difference in~     percent Cobb curve correction in a low- vs. high-implant density cohort through a~     prospective randomized controlled trial.~      Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety~     of low vs. high implant density instrumentation for spine deformity surgery in AIS patients~     with Lenke IA curve patterns.~      Interventions and Duration Intervention: low-implant density group or high-implant density~     group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old~     with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is~     174 subjects with 87 in each group.~   "
96605|NCT01792596|"~     The combination of fiber and protein added to pasta will enhance satiety.~   "
96606|NCT01792583|"~     The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the~     pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.~   "
96607|NCT01792570|"~     Clinical approach to HIV infection treatment is based on the use of highly active~     antiretroviral therapies (HAART) and recent national and international guidelines for~     guiding HIV therapy recommend the use of triple-combination therapy using antiretrovirals~     with 2 nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a~     boosted protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase~     inhibitor (II).~      In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term~     side effects, as for example the impact on renal function, remain principal problem.~      In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular~     Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk~     condition [1,2].~      Efficacy of HAART, with increase of media survival and the parallel decrease of mortality,~     has underlined the necessity to reflect on long term HAART effects [3].~      There are many evidences of HAART-related toxicity that, in spite of the necessity of a~     life-saving therapy, focus on the additional costs of this situation, in terms of health as~     well as in terms of economic costs.~      Particular attention has been focused on the impact of some drugs on renal function, as~     tenofovir, especially on tubule, without forgetting the modification of lipid and bone~     metabolisms.~      According to further studies which have evidenced the potential of some recently introduced~     molecules [4,5], the investigators had the need to realize a study to deepen the feasibility~     of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent~     NRTIs-related long-term toxicity.~      The investigators have designed a prospective randomized controlled trial, open-label, with~     a duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg~     plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia~     from at least 3 months. In fact, there are a few data about association of these drugs,~     which it has been shown to be safe, well tolerated, and with a strong pharmacological~     synergy, without nucleos(t)idic backbone, while the necessity to minimize the costs~     toxicity-related is becoming increasingly compelling.~      According to clinical experience and literature data, the investigators hope this study~     shows positive results in term of immune-virological efficacy, as well as in term of~     decrease of VACS index - a complex parameter which has the purpose to quantify general~     organic decay - and markers of lipid and bone metabolism, in group which receives~     dual-therapy versus the group with standard therapy.~   "
96608|NCT01792557|"~     Although surgical techniques such as limberg flap. modified limberg flap and karydakis are~     currently most popular treatment methods for pilonidal disease, crystallized phenol~     application is also successfully used for pilonidal sinus treatment by different centers. We~     believe crystallized phenol application could become a good alternative to popular surgical~     interventions using transposition flaps.~   "
96609|NCT01792544|"~     This study examines the impact of adding a statement to the echocardiography report that~     advises anyone reading the report regarding if and when a follow-up study is recommended.~   "
96610|NCT01792531|"~     Obesity has been shown to be resistant to treatment in adults, adolescents, and in school~     age children, but not during early childhood. Yet knowledge on the effectiveness of early~     childhood treatment programs for obesity is still very limited, preventing the widespread~     implementation of such programs. The overarching purpose of this study is to evaluate the~     effectiveness of early treatment of childhood obesity. The investigators plan to perform a~     carefully-designed randomized controlled trial that will evaluate different treatment~     options offered to families with children with obesity, organized within the healthcare~     system and followed up for at least 1 year post-baseline. Participants will be children aged~     4-6 years (N=180) with obesity and their parents. This study will facilitate a close~     examination of key treatment components and mechanisms of change. Results from this study~     will lead to better healthcare options for obesity treatment during childhood and ultimately~     to the prevention of obesity later in life from a public health perspective.~   "
96611|NCT01792518|"~     Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of~     treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after~     24 weeks of treatment.~   "
96649|NCT01791998|"~     This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial~     thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image~     guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the~     tumor cells without affecting the surrounding tissue~   "
96615|NCT01792466|"~     Endoscopic cholangiography is a procedure which is performed to image the bile duct and~     perform therapy like removal of bile duct stones. It is currently standard of care to remove~     stones from the bile duct when found as they frequently cause complications like infections~     which can sometime be life threatening.~      Therapy on the biliary tree, like for example stone removal, frequently requires inserting~     tools through the opening of the duct and cutting of the muscle which control the secretion~     of juices from the liver. Cutting the muscle helps with securing an easy access to the bile~     duct. It also helps facilitating dragging the stones out. On certain occasions placing a~     wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose~     opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a~     wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly~     because it straightens the duct. On certain occasions this also fails and we resort to~     cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access~     to the bile duct. The more attempt to enter the bile duct the higher the risk of~     inflammation in the pancreas known as pancreatitis. This makes decreasing the number of~     attempts at placing the wire in the duct desirable. One way to facilitate placement of the~     wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward~     the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct~     opening. The study is trying to answer if cutting the bile duct sphincter muscle in the~     direction of the bile duct immediately after a wire has entered the pancreatic duct will~     make it easier to place the wire in the bile duct as compared to trying to place the wire in~     the bile duct without cutting the opening. While cutting the muscle canincrease the risk of~     pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of~     pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and~     decrease the number of attempts at entering the bile duct then it might be a better way to~     approach the patient whom we had difficulty in entering the bile duct.~   "
96616|NCT01792453|"~     The GI MRI Research group at the University of Nottingham has been developing new,~     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal~     tract. The investigators now want to characterise; in collaboration with the College of~     Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel~     liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of~     water drink for oral solid dosage forms testing.~   "
96617|NCT01792440|"~     Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The~     investigators' aim was to study the relevance of clinical parameters in terms of underlying~     disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis~     bronchiectasis population.~   "
96618|NCT01792427|"~     In this study we analyzed the overall survival for all newly diagnosed patients with~     non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to~     confirm the known risk factors such as age, gender, smoking history and Pseudomonas~     aeruginosa and evaluate the impact on survival of etiology, number of different~     bacteriological species in retrospective and prospective sputa, azithromycin use and~     presence/development of pulmonary hypertension.~   "
96619|NCT01792414|"~     This study is a RCT of transcranial electrical stimulation in depressed patients. Mood,~     cognitive test performance and biomarkers will be measured during the trial.~   "
96620|NCT01792401|"~     The purpose of this study is to investigate the effect of probiotics in enteral nutrition on~     improving gut function, inflammatory markers and clinical outcomes in critically ill~     patients admitted to the intensive care unit.~   "
96621|NCT01792388|"~     Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in~     stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial~     barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a~     critical role in improving barrier function.~   "
96622|NCT01792375|"~     To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor~     induction for nulliparas at term with an unfavorable cervix~   "
96623|NCT01792362|"~     This study is a prospective before & after clinical trial to compare the basal and 3 months~     after diet anti-mullerian hormone levels between responders and non-responders to weight~     loss diet in obese infertile women with PCOS population~   "
96624|NCT01792349|"~     There is good evidence of the effectiveness of regular physical activity in the primary and~     secondary prevention of stroke. STARFISH is a smartphone-based application designed as a~     behavioural change intervention to encourage the user to become more physically active. The~     study will investigate if using STARFISH for 6 weeks can increase physical activity in~     people after stroke. Subjects will be randomised to the STARFISH intervention or a control~     group. Control subjects will not have access to their daily activity count.~   "
96625|NCT01792336|"~     Background:~        -  The brain has natural electrical rhythms of brain activities. These rhythms may be~          different in people with movement disorders, such as dystonia (involuntary muscle~          movement, cramps, or tremors). Understanding these rhythms may provide more information~          about movement disorders.~        -  Focal hand dystonia, also known as writer's cramp or musician's cramp, is a painful~          condition that affects the hand and arm muscles. Researchers want to use transcranial~          magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand~          dystonia.~      Objectives:~      - To better understand brain rhythms involved in focal hand dystonia.~      Eligibility:~        -  Individuals between 18 and 70 years of age who are right-handed and have focal hand~          dystonia.~        -  Healthy right-handed volunteers between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  This study includes two tests: a pilot test and a main test. The pilot test will~          determine the frequency of TMS that will be used in the main test. Participants may be~          in one or both tests. Each test requires a single outpatient visit that will last up to~          5 hours.~        -  Participants will have a base test to see how their muscles respond to TMS. This will~          look at the electrical activity of the muscles. Participants will have a wire coil held~          on their scalp. A brief electrical current will pass through the coil. It creates a~          magnetic pulse that stimulates the brain. Researchers will test the TMS on the right~          and left sides of the head. This will help find the spot that activates the finger~          muscles, and see how much TMS is needed.~        -  In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated~          magnetic pulses delivered in short bursts. There will be four pulses in each burst.~          Participants will have multiple bursts during the test. This test will look at how the~          muscles of the hand and fingers respond to brain stimulation.~        -  Treatment for focal hand dystonia will not be provided as part of this study.~   "
96626|NCT01792323|"~     To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at~     high rates over a short period of time (bolus delivery). The length of this period (bolus~     duration) usually depends on the chosen bolus size and on the used insulin pump model. This~     study will evaluate the impact of different bolus durations (i.e., durations commonly~     employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of~     insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin~     analogue.~      Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics~     of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different~     bolus durations.~      Study design: Single-center, randomized, controlled, two-arm cross-over intervention study~      Population: Twenty type 1 diabetic subjects~      Intervention: The investigational treatment is the subcutaneous administration of insulin~     lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a~     period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties~     will be taken during an 8-hour clamp experiment. Patients will undergo both investigational~     treatments in a randomized order; between the two clamp visits there will be a wash-out~     period of 5-21 days.~      Main study endpoint: Time to maximum glucose infusion rate~   "
96627|NCT01792310|"~     This is a phase 1/2A, open label, non-randomized study in patients with advanced solid~     tumours including malignant glioma~   "
96628|NCT01792297|"~     Bovine colostrum is the initial milk secreted by cows during the first day after calving.~     Colostrum is high in protein and contains a number of substances that have potential to be~     beneficial for the immune system. Preliminary studies about effects of colostrum~     supplementation show its potential for increasing human exercise performance; however, more~     evidence across the lifespan is required to confirm effects and to understand mechanisms of~     action. The objectives are to determine the effect of 8 weeks of bovine colostrum~     supplementation, compared to whey protein supplementation on the following dependent~     variables in men and women 50 years and older while participating in a resistance-training~     program:~        -  muscle mass~        -  strength~        -  blood levels of growth factors and markers of inflammation~        -  urine levels of muscle and bone catabolic markers~        -  tests of cognitive ability It is hypothesized that bovine colostrum supplementation~          will result in greater increases in muscle mass, strength, blood IGF-1 levels (an~          anabolic hormone), and cognitive ability, and greater reductions in inflammation, and~          markers of muscle and bone catabolism, compared to placebo.~   "
96629|NCT01792284|"~     The primary purpose of participation in this study is to compare the safety and efficacy of~     different dosing schedules of LY2605541 and how different dosing schedules of LY2605541~     affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with~     LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and 42 weeks~     total study enrollment (10 day screening period and 4 week Follow-up period).~   "
96630|NCT01792271|"~     The purpose of this research study is to examine the effects of two weeks of daily dosing of~     inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and~     cough clearance in patients with the chronic bronchitis type of Chronic Obstructive~     Pulmonary Disease (COPD.~      Defective mucociliary clearance (MCC) is central to the development and/or worsening of~     several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis~     (CF), and bronchiectasis. In each case, defective MCC leads to the development of lung~     infections and damage to the airways from ongoing inflammation caused by a person's~     inability to clear mucus from the lungs.~      The investigators' previous studies have shown that the administration of inhaled HS~     (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use~     resets the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of~     HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease~     exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS~     in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and~     its success raises optimism that similar benefits might occur in patients with CB.~      In this study the investigators will use mildly radioactive particles, technetium bound to~     sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks~     of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects~     with CB. We will also be collecting sputum and breath condensation to analyze for protein~     and inflammatory changes that might occur with exacerbations.~      Our long term goals are to improve our understanding of MCC in health and disease and to~     develop better therapies that support and/or restore MCC in patients with these diseases to~     reduce lung infections.~   "
96631|NCT01792258|"~     Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current~     literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged~     weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper~     airway obstruction. Many studies have focused on the comparison between different PDT~     techniques and complication. The aim of our study is to evaluate the procedural features,~     complications, ICU mortality, quality of life, post-discharge mortality of patients~     undergoing different PDT techniques performed in ICU.~   "
96632|NCT01792245|"~     Hand psoriasis/eczema is a common problem which is characterized by itchy, erythematous and~     scaly lesions often with a long lasting and relapsing course. Treatment is difficult with~     considerable number of patients do not or only partially respond to the current treatments.~     Several studies have shown the therapeutic effectiveness of the combination of topical~     psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand~     psoriasis/eczema. Topical PUVA is has several short- and long-term side effects. Narrow band~     ultraviolet B (NB-UVB) has emerged recently as an important treatment for a variety of~     photoresponsive diseases including psoriasis and eczema. For most conditions (other than~     hand psoriasis/eczema) NB-UVB has been shown to have similar therapeutic results to PUVA~     with less side effects. There are only a few studies published on the efficacy of NB-UVB for~     hand psoriasis/eczema. Therefore, this study is aimed at comparing the efficacy and safety~     of t-PUVA and NB-UVB in treating these conditions.~   "
96633|NCT01792232|"~     The investigators are investigating the effects of combined exposures to diesel exhaust and~     allergens on lung function and on the immune system. After exposing individuals to either~     filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The~     investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is~     passed down the throat and into the lungs) to place a small amount of allergen directly in~     the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from~     the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.~   "
96634|NCT01792219|"~     Title: The effectiveness of learning to collaborate interprofessionally on healthcare~     processes and outcomes in nursing homes: a cluster randomized controlled trial in primary~     care.~      The ageing of the population is expected to be a major driver of increasing demand for more~     complex and continuous care. The delivery of health care for this population requires high~     level of coordinated teamwork and efforts. Interprofessional collaboration can improve~     healthcare processes and outcomes. It assumes a model of working together. It is a process~     by which professionals develop an integrated and cohesive answer to the needs of the~     patients. In this study the possible effects of learning to interprofessionally collaborate~     will be investigated on health care processes and outcomes for chronic geriatric patients in~     nursing homes.~   "
96635|NCT01792206|"~     The purpose of this research study is to study the effects of paricalcitol on endothelial~     function and inflammation, cardiovascular risk factors which are associated with patient~     populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).~      Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and~     impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute~     to atherogenesis.~      Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress~     oxidative stress and inflammation and improve endothelial function and thus contribute to an~     anti-atherogenic action.~   "
96807|NCT01790152|"~     This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers~     associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of~     blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors~     learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors~     understand how well patients respond to treatment.~   "
96636|NCT01792193|"~     In previous work, the investigators analyzed the concentration of gut-derived peptides~     (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD).~     The investigators have shown that the secretion pattern differs between PD patients and~     controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g.~     Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational~     to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is~     based on the following considerations:~        -  Receptors for gut-derived peptides are expressed in Central Nervous System (CNS)~          structures that are affected by the neurodegenerative process underlying Parkinson's~          disease~        -  Gut-derived peptides are involved in the modulation of higher brain functions (mood,~          cognition, reward-related behaviour) that are frequently altered in Parkinson's~          disease.~        -  The secretion of gut peptides is (co-)regulated by the vagal nerve that is~          dysfunctional in Parkinson's disease.~        -  Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able~          to prevent cell death in neurodegenerative disorders, including Parkinson's disease.~      Objective:~      Collection of CSF and serum samples in a standardized way in order to quantitatively measure~     the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic~     peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:~        1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and~          controls?~        2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical~          and / or epidemiological characteristics of the investigated subjects (age, gender,~          BMI, disease duration, severity of motor impairments, presence of non-motor symptoms,~          co-morbidities, medication, etc.)?~   "
96637|NCT01792180|"~     The Senior Step Study investigates whether feedback given by a mobility feedback device in~     combination with an instruction book containing every day exercises, motivates elderly to~     exercise more. By exercising more participants take charge of their own mobility and fall~     risk. Senior Step Study studies whether this 'exercising more' positively affects their~     mobility, fall risk, mental wellbeing, self-management, and quality of life.~   "
96638|NCT01792167|"~     This study is a large-scale, randomized longitudinal evaluation of Second Step: Student~     Success Through Prevention (Second Step - SSTP), a middle school intervention (Committee for~     Children, 2008), which targets the shared underlying risk and protective factors for~     bullying, sexual harassment, and dating aggression. This program is unique in its emphasis~     on the role of peer group norms, attitudes, and behavior in the initiation and maintenance~     of bullying and other forms of violence. Because of this, this investigation will involve a~     direct test via social network analysis the extent to which peer norms or shifts in peer~     attitudes are impacted by the intervention. Bullying is conceptualized as including verbal,~     physical, relational, and cyber-aggression. Sexual violence is conceptualized as including~     sexual harassment, sexual coercion in dating relationships, and homophobic teasing.~     Thirty-six schools were drawn from four school districts in Illinois and one large district~     in Wichita, Kansas and randomly assigned to Second Step - SSTP or a control condition.~     Second Step -SSTP program draws from the risk/protective factors model and social-cognitive~     theories of aggression. Lessons focus on the outcomes of bullying, relational aggression,~     sexual harassment, dating relationships, and substance use. Risk factors targeted include~     inappropriate classroom behavior, favorable attitudes toward aggression and substance abuse,~     deviant peer affiliation, peer rejection, and impulsiveness are targeted as risk factors.~     Targeted protective factors include empathy, problem-solving skills, school connectedness,~     assertiveness and adoption of conventional norms. The P3R: Stories of Us - Bullying program,~     composed of a series of film-based education will be used in the control schools. All 6th~     graders at each school will be recruited and followed for the three year study period.~     Students and teachers will complete self-report and nomination tasks. Growth curve analysis~     via hierarchical linear modeling (HLM; Bryk & Raudenbush, 1992) will be utilized to assess~     change in the major dependent variables (bullying, sexual harassment perpetration, dating~     aggression), structural equation modeling will test for mediators across the study period,~     and social network analysis will be instrumental in identifying peer norms and attitudes.~   "
96639|NCT01792154|"~     Assess changes in the corneal cell count using Specular Microscopy following tretments with~     Anti-VEGF injections~   "
96640|NCT01792141|"~     The use of Indocyanine green diagnostic dye will identify areas of vascular leakage which~     will provide more effective laser treatment by targeting these specific areas.~   "
96641|NCT01792115|"~     Background:~        -  Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver~          cells. It is associated with obesity, high blood pressure, high cholesterol, and~          diabetes. Some people with NAFLD only have excess fat in the liver. However, other~          people may develop a worse form of NAFLD with liver injury and scarring. This form,~          called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer,~          and death. Not much is known about why some people develop NASH and others do not.~        -  Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage~          in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of~          vitamin E used in these studies is almost 40 times the recommended amount of vitamin E~          intake from food. It is unclear whether a lower dose could achieve the same effect.~          Researchers also want to study how vitamin E works at different doses to treat NAFLD.~      Objectives:~        -  To find out the most effective dose of vitamin E to treat NAFLD.~        -  To gain a better understanding of how NAFLD and NASH develop, and predict who will~          respond to treatment.~      Eligibility:~      - Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  For the first 12 weeks of the study, participants will meet with a nutritionist. They~          will have personalized diet and exercise plans. Treatment will be monitored with~          diaries and questionnaires to fill out at home. Participants will also wear a pedometer~          to measure physical activity.~        -  After the 12-week period, participants will have a full physical examination with the~          following tests:~        -  Blood tests~        -  Glucose tolerance tests~        -  Imaging studies (DEXA scan and magnetic resonance imaging)~        -  Liver and fatty tissue biopsy~        -  Two weeks after the tests, participants will start vitamin E treatment. They will take~          up to two pills a day, taken with fat-containing foods.~        -  4 weeks after starting treatment they will have a repeat full evaluation with imaging~          tests, blood work, and liver and fat biopsies.~        -  Participants who are taking vitamin E will take it for up to 120 weeks. They will have~          monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another~          full evaluation, with imaging tests, blood work, and liver and fat biopsies.~   "
96642|NCT01792102|"~     This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to~     evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib~     for patients with progressive multiple myeloma.~   "
96643|NCT01792089|"~     8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months~     post-bypass, and 8 subjects matched to the post-bypass patients will be studied after~     ingestion of two or three different of the following test-meals: A)cream and whey protein~     B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein,~     fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated~     by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48~     in blood~   "
96644|NCT01792063|"~     In our study we aim to study the effects of two preparations of Sevoflurane in vital~     capacity rapid inhalation induction.~   "
96645|NCT01792050|"~     The purpose of this study is to compare the effects, good and/or bad, of standard of care~     therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan~     (referred to as indoximod) an experimental drug to find out which treatment is better.~   "
96646|NCT01792037|"~     we aim to evaluate the effects of single dose of etomidate or use of steroid prior to~     etomidate during emergency intubation on hemodynamics and adrenal cortex.~   "
96647|NCT01792024|"~     This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial~     thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense,~     narrow beams of light to cut and destroy tissue and may help treat prostate cancer~   "
96648|NCT01792011|"~     The aim of this study is to compare the accuracy of PVI (pleth variability index)~   "
96808|NCT01790139|"~     To determine whether colonic bubbles associated with CT colonography performed with iohexol~     for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic~     preparation.~   "
96650|NCT01791985|"~     This study is looking at a new drug called AZD4547 which is being tested for the treatment~     of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically blocks~     proteins called fibroblast growth factor receptors (FGFR1) that are involved in the~     processes that help cancer cells to grow. These proteins may also be responsible for the~     development of resistance to hormonal therapies used to treat some breast cancers. AZD4547~     is not yet approved for use in breast cancer and is therefore being used in this study as a~     research drug.~      The investigators will also test the theory that it is not necessary for high levels of~     FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)~   "
96651|NCT01791972|"~     The primary objective of this study is to evaluate the efficacy of a single dose (2~     inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in~     patients with EIB.~   "
96652|NCT01791959|"~     To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50~     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be~     randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will~     be advised to adherence our diet and exercise program too. At the first and the end of the~     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis~     will be assessed and compared between groups.~   "
96653|NCT01791946|"~     The primary objective of this study is to assess the effectiveness of an investigational~     binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy~     eye, or poor vision in one eye due to a present or former eye misalignment). Patients will~     be randomized to receive the study treatment either before or after strabismus surgery~     (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study~     hypothesis is that there will be no significant change in vision in neither the pre nor~     post-surgery groups and no significant change in vision in neither the sham nor actual~     treatment groups.~   "
96654|NCT01791933|"~     The purpose of this study is to investigate the effect of CAM treatments consisting of~     herbal medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and~     cervical spine pain patients due to spinal disease.~   "
96655|NCT01791920|"~     To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to~     severe glabellar lines.~   "
96656|NCT01791907|"~     Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes~     patients in the world. Diabetes a serious disease in which life expectancy is reduced,~     largely due to increased mortality from kidney disease and cardiovascular (CVD) disease.~     Poor glycemic control also results in eye and nerve damage, and psychosocial stress. Good~     metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids,~     reduces the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize~     blood sugar levels, improve blood lipids and prolong life in people with diabetes, according~     to Swedish Council on Health Technology Assessment (SBU).~      Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project~     aims to evaluate two methods of structured training in patients with type 1 diabetes:~        1. A structured education in carbohydrate counting, a course inspired by the DAFNE program~          (Dose Adjustment For Normal Eating)~        2. A new, structured education for heart healthy food choices and low glycemic index in~          type 1 diabetes. The education is called My Wellness-LADDER (Lifelong Adult Diet &~          Diabetes Education Resource) and it is specifically designed to provide high long-term~          adherence through improved empowerment and transformative life style change.~      The methods are compared with regular routine (control group).~      This is a randomized controlled trial with three intervention groups 1) Healthy food choices~     with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow‐up~     period is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each~     clinic are to be enrolled.~      The hypotheses is that structured group education on heart healthy food choices and low~     glycemic index provide the same improvement in glycemic control and quality of life as~     advanced carbohydrate counting in T1DM, as compared to regular routine. An additional~     hypotheses is that structured education on healthy food choices and low glycemic index leads~     to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular~     routine and that structured education on healthy food choices and low glycemic index lead to~     more heart healthy food choices in T1DM compared to carbohydrate counting and regular~     routine. Lastly, the hypotheses is that structured education on healthy food choices and low~     glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and~     regular routine.~   "
96657|NCT01791894|"~     This pilot clinical trial studies arsenic trioxide in treating patients with basal cell~     carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stop them from dividing~   "
96658|NCT01791881|"~     To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against~     Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA~   "
96659|NCT01791868|"~     Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency~     associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of~     patients are discharged from the hospital within the first month after GCSE. Recent~     Guidelines from Experts highlight the necessity to improve the efficiency of the first line~     anti-epileptic (AE) therapy.~      Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line~     AEs. Intravenous SV is available, well tolerated and easily injectible but also has~     pharmacologic properties for reducing the risk of seizures relapses and for being~     neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never~     been properly assessed.~      Primary Purpose The primary purpose is to assess if the association of intravenous Sodium~     Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus~     increases to 20 % the number of living patients, discharged from the hospital at day 15.~   "
96660|NCT01791855|"~     Patients with renal impairment are the target population for PF-04634817. The clearance~     mechanism of this drug means that exposure may be increased in subjects with renal~     impairment. This study will investigate the effect of the drug in subjects with varying~     degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.~   "
96661|NCT01791842|"~     Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small~     proportion of patients fail to respond adequately. Mutated bone cells produce large amounts~     of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may~     be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a~     placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can~     reduce bone resorption in those patients with fibrous dysplasia who have already received~     bisphosphonates.~   "
96662|NCT01791829|"~     This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral~     breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women~     postulated to be at low risk for recurrence. Women with luminal A breast cancer determined~     by immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated~     with endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be~     treated with breast irradiation (BI). Subjects will be followed for 10 years and will be~     assessed for recurrent disease, new primary cancer and survival.~   "
96663|NCT01791816|"~     Vasovagal Syncope (simple postural faint) is the most common cause of acute loss of~     consciousness. Postural tachycardia syndrome(POTS) is the most common chronic form of~     postural lightheadedness. Together they afflict many Americans, mostly young women, who are~     prevented from gainful employ or school attendance. The underlying mechanism is not known.~     Our past work suggests that a simple molecule, nitric oxide, acts to subvert normal blood~     flow controls causing blood to pool in the gut when standing. Our proposal will show the~     mechanism behind this problem and will indicate effective medical treatments. Patients will~     be compared to healthy control subjects.~   "
96664|NCT01791803|"~     Smoking-related cardiopulmonary diseases account for a large number of hospital admissions.~     We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking~     cessation program in improving quit rates of hospitalized smoking patients at 12 and 26~     weeks after hospital discharge. We compared outcomes with hospitalized patients who received~     more conventional therapy, namely nicotine replacement therapy, or patients who decided to~     quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after~     hospitalization among patients admitted with a cardiac or pulmonary diagnosis.~   "
96665|NCT01791790|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in~     young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a~     memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory~     activity typically occuring during SWS has been implicated in the consolidation effect.~     Recent evidence in young healthy subjects suggest that the sleep-associated consolidation~     effect can be amplified by the application of a weak transcranial oscillatory electric~     current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly,~     healthy subjects benefit from transcranial slow oscillatory stimulation (tSOS) during~     nocturnal sleep as well has not been studied so far. The primary aim of the present study is~     to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on~     declarative memory consolidation applied during periods of nocturnal SWS in elderly healthy~     subjects.~   "
96666|NCT01791777|"~     The proposed study will compare purveyor coaching (conducted by National SafeCare Training~     and Research Center (NSTRC)) to local coaching that is supported by the purveyor (NSTRC).~     The outcomes of interest are home visitor fidelity and competence with the SafeCare model,~     and family engagement and skill acquisition. The study will also include a rigorous cost~     effectiveness analysis, and will examine individual and organizational factors that may~     affect implementation.~   "
96667|NCT01791764|"~     This study has the following objective:~      To identify related factors to hospital mortality in patients with ST-segment elevation~     acute myocardial infarction submitted to pharmacoinvasive strategy within a structured~     healthcare network.~   "
96668|NCT01791751|"~     The purpose of this study is to evaluate the effect on LH levels of the 5-day CC~     administration during luteal phase in oocyte donors, to investigate whether the CC corrects~     the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the~     agonist triggered antagonist cycles.~   "
96669|NCT01791738|"~     The proposed study is a double-blinded randomized controlled trial comparing patient~     specific instruments with solely standardized instruments and pre-operative planning used~     for the placement of the acetabular cup prosthesis used in total hip arthroplasty.~      The investigators will enroll 36 patients who have consented to total hip arthroplasty for~     treatment of hip pathology. This treatment is a standard of care. Patients will receive~     standard of care pre- and post-operative care and placement of standard of care implants all~     of which are commercially available and FDA approved for general use for the clinical~     indications used in these patients. All patients will receive a pre-operative CT scan for~     surgical planning and comparison with post-operative CT scan. The difference in intervention~     between the groups will be the creation and use of patient specific instruments from the~     pre-operative planning session. These instruments will be used for placement of an indexing~     peripheral guide wire to direct acetabular preparation and placement of the shell assisting~     standard surgical instruments. Print-offs from the pre-operative plan will also be used in~     the treatment group.~      The post-operative scan will be performed within two weeks of the surgery for both the~     treatment and control groups. The investigators will analyze the difference in acetabular~     shell placement (acetabular version and abduction angle) from the pre-operatively planned CT~     scan. These differences will be compared between the control and experimental groups.~   "
96670|NCT01791725|"~     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group,~     three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4~     weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive)~     without dementia.~   "
96671|NCT01791712|"~     Following the concept of peak concentration hypothesis, which suggest the cutting peak of~     pro- and anti-inflammatory mediators would result in restoring a situation of~     immunohomeostasis. The investigators conducted the prospective randomized controlled trial~     aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux~     hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level~     during sepsis is postulated to improved outcomes in sepsis.~   "
96672|NCT01791699|"~     Hypothesis: Modulation of central nervous sympathetic activation by administration of~     moxonidine, a centrally acting medication which decreases the sympathetic nervous system~     activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment~     with pulmonary vein isolation.~   "
96673|NCT01791686|"~     This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease~     (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in~     pediatric and adult patients with DDD. After screening, eligible patients will be entered~     into the Induction Period. The Induction Period is up to 4 weeks. Following normalization of~     complement activity, patients will enter into the Maintenance Period.The total treatment~     duration is up to 26 weeks.~   "
96674|NCT01791673|"~     The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation~     using HIFU in glaucoma patients~   "
96827|NCT01789892|"~     The purpose of this study is to determine whether giving an anti-inflammatory medication~     (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or~     eliminate false findings related to inflammation~   "
96675|NCT01791660|"~     Protocol is intended for the clinical evaluation of fat reduction in male breasts~     (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system~     has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the~     flanks, and is commercially available.~      Primary study endpoint is changes in the shape and reduction of the fat in the breast as~     established by photographic imaging and ultrasound imaging of the treated area.~      Secondary endpoints will provide supportive data to evaluate device performance (subject~     satisfaction & fat reduction measured with ultrasound).~   "
96676|NCT01791647|"~     The aim of this study is to compare the effects of six months treatment of two~     insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women~     affected by polycystic ovary syndrome. The study group includes 40 patients, randomly~     allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day).~     The investigations include menstrual pattern and hirsutism score evaluation, hormonal~     assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at~     baseline and after six months of treatment.~   "
96677|NCT01791634|"~     Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and~     Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased~     intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus~     the proximal chevron osteotomy?~   "
96678|NCT01791621|"~     Irritable bowel syndrome (IBS) sufferers often find that specific foods can exacerbate their~     symptoms; identifying which foods involves a long and arduous process. Different food~     allergy tests are marketed to IBS sufferers and healthcare practitioners as an easy way to~     identify these offending foods. Which test method might be best to use? This project~     compares the results of different food allergy methods versus an elimination/challenge diet~     to determine which method maybe superior in IBS sufferers.~   "
96679|NCT01791608|"~     Acute respiratory infection and acute diarrhea are among the most prevalent diseases of~     childhood increase the burden of morbidity and mortality in children under 5 years.~      Among the possible strategies for its prevention is important to count on good nutritional~     status for use in developing a good immune response to infections. Zinc deficiency has been~     shown to favor the development of infections and has been considered a real public health~     problem.~      Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that~     has shown evidence of being better absorbed and tolerated.~      We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in~     the prevention of acute diarrheal disease and acute respiratory infection.~   "
96680|NCT01791595|"~     The main aims of this clinical study are to find out the maximum dose that can be given~     safely to patients, the potential side effects of the drug and how they can be managed and~     what happens to AZD3965 inside the body.~      AZD3965 is a type of drug called a monocarboxylate transporter 1 inhibitor which is being~     used to stop the growth of cancer cells and kill cancer cells by blocking the action of one~     of the proteins involved in moving chemical compounds in and out of the cells of the body.~     This will be the first time that this type of drug has been given to patients.~      The drug is a capsule and is taken daily. The study is in two parts. In Part 1, small groups~     of patients will be treated at increasing doses to find the highest safe dose and best dose~     to give to patients in Part 2 of the study. Approximately 18 patients with advanced solid~     tumours or lymphomas will be treated in this part.~      In Part 2, the dose found to be safe in Part 1 will be given to three groups of patients~     with either prostate cancer, gastric cancer or diffuse large B cell lymphoma. 15 patients~     will be treated in each group.~      Patients will need to visit the hospital weekly for two months and then every fortnight.~     Patients will have regular blood and urine tests, scans, heart traces and eye tests amongst~     other clinical tests. Research blood samples will also be taken to look at what happens to~     the drug inside the body. Treatment will continue until a patient's cancer starts growing~     but can continue for up to a maximum of 12 months if the cancer is responding to the drug.~     It is important to explain that this is the first study of this drug and patients will have~     advanced cancer so it is unlikely that patients will benefit directly from taking part but~     the study may help improve future treatment of cancer.~   "
96681|NCT01791582|"~     To assess performance of resp rate parameter in a monitoring system PCBA-1~   "
96682|NCT01791569|"~     To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications~     when the sensor is removed from the finger.~   "
96683|NCT01791556|"~     The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044).~     The purpose of this study is two-fold. The first purpose is to see if routine monitoring of~     the level of HIV virus in the blood (viral load) every six months is superior to monitoring~     by standard clinical evaluations and or immune status (CD4 count) with intermittent viral~     load monitoring in adults receiving antiretroviral therapy (ART). The second purpose is to~     understand the cost implications and possible benefits of routine HIV viral load monitoring.~   "
96684|NCT01791543|"~     The purpose of the study is to assess the effectiveness and safety of a new device called an~     Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating~     and ablating ventricular tachycardia that has failed standard radiofrequency ablation. This~     approach is desirable because some people have ventricular tachycardia that originates deep~     within the heart muscle where it is not abolished by ablation with standard catheters.~      The investigators seek to determine whether the INA catheter can potentially help people who~     have ventricular tachycardia that has failed standard radiofrequency ablation. The~     investigators also want to determine if it is likely to be safe, without excessive side~     effects.~   "
96709|NCT01791218|"~     A substantial proportion of patients undergoing elective coronary artery bypass grafting~     have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse~     short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be~     effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with~     coronary artery bypass grafting, aortic valve replacement for aortic stenosis and~     combination of them. Procedure is well defined and safe.~      There is a lack of convincing evidence of the effect on postoperative atrial fibrillation~     burden, quality of life and symptoms especially in correlation with atrial fibrillation~     paroxysms.~   "
96685|NCT01791530|"~     Justification and background Ventilator-associated complications (VACs) are those~     complications that develop during a period of intubation of a patient . Pneumonia is the~     second most frequent infectious complication in the hospital, and ranks first in ICU, whose~     risk is increased more than 20 times by the presence of invasive mechanical ventilation and~     is called ventilator-associated pneumonia (VAP) . Whereas the information published~     regarding VAP in terms of diagnosis, treatment and impact on the outcome of critically ill~     patients is enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and~     complicated in part, since the definition remains controversial. In addition, the~     significance of tracheobronchial colonization as a risk factor for subsequent lower~     respiratory tract infection remains unclear . The upper and lower airways can become~     colonized . Several factors have been taken into account and do not differ from those~     involved in VAT and VAP development in patients under mechanical ventilation.~      Definition VAT diagnosis is controversial and represents an actual problem in order to~     define the real incidence of VAT , There is currently no valid, reliable definition for VAT,~     and even the most widely-used VAT criteria and definitions are neither sensitive nor~     specific. The diagnosis of VAT is considered when a patient under invasive mechanical~     ventilation starts with fever, leukocytosis and new or increased purulent secretions by the~     endotracheal tube. A particular difficulty with much commonly used VAT definition (in order~     to distinguish from VAP) is the key point of the absence of pulmonary consolidation.~     Evidence suggests that chest radiograph findings do not accurately role out VAP. A taskforce~     on hospital-acquired pneumonia, and VAP has been recently published (European Respiratory~     Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID)~     and European Society of Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis~     definition includes occurrence of purulent tracheal secretion after ≥48 h of hospitalisation~     or mechanical ventilation plus ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C),~     leukocytosis (≥12 × 109/L), significant bacteriologic counts in respiratory secretions (≥103~     cfu/mL for protected brush specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates);~     absence of new pulmonary infiltrates compatible with pneumonia and absence of other causes~     of fever are mandatory. This definition needs to be further validated and can overdiagnose~     the incidence of VAT (and overuse of antibiotics) because the positive culture of~     respiratory secretions is not a mandatory item RATIONALE Given the possible high incidence~     of VAT, and its importance as a risk factor for VAP, and a potential target to treat in~     order to reduce VAP incidence, a large multicentre~   "
96686|NCT01791517|"~     The purpose of this study is to evaluate the clinical and laboratory performance of three~     brand name contact lenses with three recently introduced multipurpose lens care solutions~     (test solutions) as well as a peroxide disinfecting solution (control solution).~   "
96687|NCT01791504|"~     The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and~     effective alternative to drains(standard of care) for fluid management following~     abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate~     reduction or closure of dead space when applied to planar surfaces created during an~     abdominoplasty procedure.~   "
96688|NCT01791491|"~     The purpose of this study is to evaluate how well adolescent kidney transplant patients~     tolerate a single dose of belatacept they receive at least 6 months after transplant~     surgery, and how their body handles the drug.~   "
96689|NCT01791478|"~     This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when~     given together with letrozole in treating patients with hormone receptor-positive metastatic~     breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some~     of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast~     cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719~     together with letrozole may kill more tumor cells~   "
96690|NCT01791465|"~     This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide~     extended-release formulation) on blood sugar levels and serum markers of inflammation in a~     cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated~     diabetes mellitus. Previous studies have shown that high levels of persistent systemic~     inflammation predict the development of cardiovascular and metabolic diseases in~     HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial~     infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of~     non-HIV infected persons, which suggests that this agent may represent a unique and~     preferred medication for the treatment of insulin resistance in HIV-infected adults. The~     Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve~     glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6)~     and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the~     development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated~     adults.~   "
96691|NCT01791452|"~     Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence~     estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic~     heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to~     90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients~     are of especial practical and theoretical importance. Cholesterol Ester Storage Disease~     (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a~     deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in~     tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with~     varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases,~     and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is~     poorly understood, the investigators propose to evaluating the association between NAFLD and~     LAL deficiency in a prospective study in our population.~   "
96692|NCT01791439|"~     The investigators wish to determine if application of 2% lidocaine soaked gauze to the~     peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope~     assisted tracheal intubation in the morbidly obese.~   "
96693|NCT01791426|"~     The objective of this investigation is to show that the performance of Artelac Rebalance eye~     drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry~     eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment~     administered 3 to 5 times per day.~   "
96694|NCT01791413|"~     The purpose of this study is to evaluate the ovarian reserve changes after preoperative~     depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing~     laparoscopic cystectomy.~   "
96695|NCT01791400|"~     The purpose of this study is to determine which drug makes lower migraine headache~   "
96710|NCT01791205|"~     This is a multicenter observational study in patients with rheumatoid arthritis in routine~     clinical practice in Italy. In the retrospective Part 1 of the study, clinical and~     demographic factors associated with the use of a biologic drug in monotherapy as compared to~     therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be~     evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the~     use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be~     followed for up to18 months.~   "
96711|NCT01791192|"~     This study will assess the safety, tolerability, and efficacy of FTY720 in patients with~     acute, noninfectious intermediate, posterior and pan uveitis~   "
96696|NCT01791387|"~     The main purpose of this study is to find out how useful dovitinib is when given as the~     initial treatment to participants with advanced kidney cancer, that has spread to other~     parts of the body. The usefulness of dovitinib will be assessed by: how long the disease is~     controlled while participants are receiving the drug, the proportion of participants who get~     a reduction in the size of their tumours and how long participants live (both while on~     dovitinib and on any subsequent therapy they may receive).~      If participants have secondary disease in the bones, the study will evaluate how useful~     dovitinib is in controlling this site of disease. In addition, this study will look for~     changes in the genetic makeup of tumour cells and see if some of these changes are~     associated with a benefit from dovitinib. The study will also compare and contrast the~     genetic changes in the primary tumour cells with cells from secondary tumour specimens, and~     with cells from tumour specimens taken if a participant's disease has worsened. The purpose~     of the latter is to identify possible ways in which the tumour becomes resistant to the~     study drug.~   "
96697|NCT01791374|"~     This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced~     solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.~   "
96698|NCT01791361|"~     This non-interventional retrospective medical record review study will assess the prevalence~     of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in~     patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European~     countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation~     testing, this study will also assess data from the laboratory that performed the KRAS test.~     The study will also monitor changes in the pattern of Vectibix treatment between the~     different rounds of the study.~   "
96699|NCT01791348|"~     The d2 test of attention has been used in studies regarding sleep deprivation due to night~     shifts in hospital staff, in order to determine whether sleep deprivation has an impact on~     performance. However, by repeating the test there appears to be a test-retest effect, as the~     participants improve when performing the test more than once. The aim of this study is to~     determine, whether the d2 test of attention has a test-retest effect.~   "
96700|NCT01791335|"~     Noninvasive ventilation (NIV) can provide ventilatory support in selected patients with~     acute respiratory failure, for instance due to acute exacerbation of COPD and acute heart~     failure. Advantages of noninvasive ventilation compared to invasive mechanical ventilation~     include absence of complications associated with endotracheal intubation, lower risk of~     pneumonia, lower level or even absence of sedation and the ability of the patient to~     verbally communicate. However, in approximately 30% of patients NIV fails and endotracheal~     intubation is needed to provide optimal ventilatory support. Surprisingly, very few studies~     have investigated why patients fail on NIV. Clinical observations indicated that agitation,~     delirium and most importantly asynchrony between patient and ventilator play a role in~     unsuccessful support with NIV. The upper airways are bypassed during endotracheal~     intubation. However, with NIV the upper airways may play a role in the efficiency of~     ventilatory support. In normal breathing the upper airways actively dilate before initiation~     of inspiratory flow. This is a highly appropriate response as it prevents narrowing of the~     upper airways during inspiration, which would result in elevated inspiratory resistance.~     Experiments in newborn lambs have shown that NIV has profound effects on physiology of the~     upper airways. Positive pressure during inspiration results in constriction of upper airway~     muscles in the early phase of inspiration. This results in elevated upper airway resistance~     with lower tidal volume delivered to the lungs. Subsequent studies revealed that reflexes~     that mediate this response originate in vagal afferences located in the lower airways. From~     an evolutionary point of view this might be an appropriate response, as high pressure~     delivered to the lungs may induce barotraumas. However, these responses may negatively~     affect the efficiency of ventilatory support delivered during NIV. The understanding of~     upper airway constriction and dilation during NIV is rudimentary. This study aims at~     determining the effect of NIV on regulation of upper airway patency in patients with COPD.~   "
96701|NCT01791322|"~     NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on~     patient derived tumor tissue. The assay is able to sense activating mutations by monitoring~     their effect on a chip-based device.~   "
96702|NCT01791309|"~     The purpose of this study is to test a new drug combination consisting of two drugs,~     vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This~     treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have~     changes in the BRAF gene that may make them more likely to respond to this new drug~     combination.~   "
96703|NCT01791296|"~     Specific Aims~        1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU~          at 2 different sites. Specifically will be estimating the recruitment rates of patients~          and the compliance with both interventions.~        2. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine~          using adverse effects and withdrawal rates as indicators.~        3. Measure the effect of nocturnal dexmedetomidine on pertinent clinical outcomes and use~          this outcome data to plan a larger, multicenter trial in this area.~      The goal of this study is to determine whether a night-time protocol that incorporates a~     pharmacologic intervention associated with improved sleep (i.e. dexmedetomidine) will~     improve sleep quality and reduce the incidence of delirium and sub-syndromal delirium in~     critically ill patients.~   "
96704|NCT01791283|"~     Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform~     analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac~     magnetic resonance imaging (CMRI)~   "
96705|NCT01791270|"~     To describe the relationship between OSA and clinical Hypertension (performing ABPM),~     endothelial dysfunction (performing flowmetry), and its relation at the basic research~     (determining the β1 subunit in Peripheral Leukocytes in peripheral blood). This relation~     between OSA and HTA has been evaluated in basal conditions and after modifying the~     pathophysiological role of OSA applying treatment with positive continues pressure (CPAP)~     during 3 months.~   "
96706|NCT01791257|"~     The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from~     patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.~   "
96707|NCT01791244|"~     This is a randomized, comparative, and multicenter study to assess the impact of a patient~     support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in~     subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™~     device.~   "
96708|NCT01791231|"~     The purpose of this study is to investigate the absorption (the way the drug enters the~     body), metabolism (the way the drug is broken down in the body), and excretion (the way drug~     leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single~     dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of~     canagliflozin will also be assessed.~   "
96712|NCT01791179|"~     Substance abuse is highly prevalent among individuals with HIV and associated with negative~     outcomes including poorer medication adherence and HIV risk behavior. The primary aim of~     this project is to address substance abuse among individuals with or at high-risk for HIV by~     enhancing and expanding the substance abuse services provided in the formerly Substance~     Abuse and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug~     Expansion Team (CADET) program, which offered comprehensive substance abuse care for~     individuals with HIV living primarily in the Durham NC area. Services will be enhanced by~     adding peer outreach and navigation services to improve treatment engagement and~     participation and expanded to replicate the enhanced CADET service model in Charlotte NC.~      The target population for this project is minority individuals, primarily African-Americans,~     with HIV or at high-risk for HIV with a particular focus on minority men who have sex with~     men (MSM)s. The program will provide up to 18 months of comprehensive services for~     approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance~     treatment engagement 2) individual and group substance abuse treatment using evidence-based~     models 3) ongoing recovery groups for individuals who have completed the intensive substance~     abuse treatment phase and 4) linkage to needed services such as case management, psychiatric~     care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and~     treatment services for minority MSM of unknown HIV status to increase access and utilization~     of substance use services and identify HIV and Hepatitis status.~      The study evaluation will involve analysis of participant survey data gathered at baseline,~     6, 12, 18 months of study participation to determine the effect of the comprehensive~     substance abuse care services on outcomes for individuals with HIV including substance use,~     mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV~     services. The study will also determine the effect of the comprehensive substance use~     program on substance abuse, mental health, and risk behavior outcomes for minority MSM who~     are not HIV-positive.~   "
96713|NCT01791166|"~     Open multicentric prospective study performed on pulmonary transplanted patients to detect~     the values of different diagnostic markers for immuno- humoral reaction and their roles in~     the humoral rejection for those patients.~   "
96714|NCT01791153|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with giant cell~     arteritis. Patients will be randomized to receive either RoActemra/Actemra 162 mg~     subcutaneously weekly or every 2 weeks or placebo for 52 weeks, with tapering oral daily~     doses of prednisone. After Week 52, patients in remission will stop study treatment and~     enter long-term follow-up, whereas patients with disease activity or flares will receive~     open-label RoActemra/Actemra 162 mg subcutaneously weekly for a maximum period of 104 weeks~     at the discretion of the investigator. Anticipated time on study is 39 months.~   "
96715|NCT01791140|"~     This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in~     combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of~     age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until~     disease progression, death, withdrawal of consent, discontinuation of physician-patient~     relationship or study closure, whichever comes first.~   "
96716|NCT01791127|"~     The objective of the SIELLO study is to demonstrate the safety and effectiveness of the~     BIOTRONIK Siello S pacing lead.~   "
96717|NCT01791114|"~     Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold~     exposure via adrenergic stimulation activates BAT, which combusts significant amounts of~     blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT~     activation improves insulin sensitivity. However, the effect of cold-induced BAT activation~     on insulin sensitivity and glucose kinetics in humans remains unknown. The investigators'~     central hypothesis is that cold-induced BAT activation increases whole body insulin~     sensitivity in humans via augmented plasma glucose and FFA clearance. The specific aims of~     this study are to define the effects of prolonged (8h) cold exposure BAT activation on:~     insulin sensitivity (Aim 1); lipolysis and plasma glucose and FFA kinetics (Aim 2); on~     thermoregulation (Aim 3). Moreover, the investigators plan to investigate for alternative~     ways, which can activate BAT including cold water ingestion, a single meal ingestion, and a~     single bout of moderate intensity exercise (Aim 4). For the cold exposure study, subjects~     will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering~     threshold; b) 8hrs of cold exposure at their individually determined shivering threshold~     plus propranolol; c) 8hrs in thermoneutral conditions (26 - 28°C). For the rest of the arms~     of subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion~     or no food ingestion, and a single bout of moderate intensity exercise or no exercise.To~     study the above aims, the investigators will use positron emission tomography - computed~     tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue~     biopsies. The findings will illuminate the role of BAT on plasma substrate regulation and~     insulin sensitivity and may aid in the development of lifestyle recommendations and~     pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.~   "
96718|NCT01791101|"~     This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily.~     If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if~     patients will achieve response after 2 months of therapy, they will continue eltrombopag for~     a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be~     enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the~     trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In~     stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of~     40 patients, it will be concluded that the study drug is not active enough. If ≥ 13~     responses will be observed, it will be concluded that eltrombopag is worth of further~     studies.~   "
96719|NCT01791088|"~     This clinical trial studies sirolimus in treating patients with solid tumors that are~     metastatic or cannot be removed by surgery. Sirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
96720|NCT01791075|"~     The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector~     in terms of damage to the donor corneal endothelium by comparing the endothelial cell loss~     at 1 month, 3 months, 6 months, and 1 year post DSAEK (Descemet's Stripping Automated~     Endothelial Keratoplasty)surgery. There is no data comparing this two injectors.~   "
96721|NCT01791062|"~     The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified~     porcine splint-skin which contains natural pores, and a lower layer of highly purified~     collagen fleece containing hyaluronan (HA).~      In this study, the medical device will be used and evaluated in a one-step procedure~     combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support~     haemostasis in the articular cartilage defect, act as a support for cell growth and as a~     three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying~     tissue after cartilage debridement and/or microfracturing of the subchondral bone.~      The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to~     support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage~     regeneration in a one-step surgical procedure.~   "
96722|NCT01791049|"~     TD-1607, administered intravenously as single doses, will be investigated in healthy~     subjects to assess its tolerability, safety, and pharmacokinetics.~   "
96723|NCT01791036|"~     Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL~     reconstruction surgery, yet result in less motor blockade than a femoral block.~   "
96764|NCT01790711|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles~     in the body's metabolism. Evidence from animal and human studies strongly support the link~     between intestinal bacteria and type 2 diabetes mellitus. The present clinical trial aims to~     re-establish a gut functionality state of intestinal flora through fecal microbiota~     transplantation.~   "
96724|NCT01791023|"~     Depressive elderly individuals have showed higher basal level of cortisol and lower level of~     dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed~     in reactivity of an acute stress, such as physical exercise. On the other hand, physical~     training can modulate the release of these hormones. Therefore, depressive elderly~     individuals physically actives might show attenuated reactivity of an acute physical~     stressor compared to sedentary elderly individuals. The aim of these study is to compare the~     effect of an acute physical stressor on cortisol levels in depressive and healthy~     individuals, physically actives and sedentaries. Additionally, the sulfated form of DHEA~     (DHEAS) serves as a reservoir for DHEA, because of that it is expected that DHEAS levels~     might reduce after the acute physical exercise.~   "
96725|NCT01791010|"~     Aging causes anatomical and physiological changes in the respiratory system and respiratory~     muscle strength with decline in its maximum function. This study aimed to evaluate the~     effects of inspiratory muscle training on respiratory muscle strength, thickness of the~     diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that~     inspiratory muscle training improves respiratory muscle strength, the thickness of the~     diaphragm and diaphragmatic mobility in older women.~   "
96726|NCT01790997|"~     This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with~     3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical~     outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as~     active controls.~   "
96727|NCT01790984|"~     The hypothesis of this study is that a diet high in sugars will increase abnormalities in~     blood lipids which are associated with increased cardiovascular disease risk, relative to a~     diet which is low in sugar. We predict that this potentially adverse effect of dietary~     sugars on blood lipids will be more pronounced in people with a raised level of stored fat~     inside their liver, as compared to people with a low level of stored fat.~   "
96728|NCT01790971|"~     Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to~     medications that suppress pharyngeal muscle activity such as general anesthetics and~     opioids. Opioids can depress the ventilator response to airway obstruction and inhibit the~     awakening response to hypoxia and hypercarbia, resulting in central respiratory depression.~     OSA is therefore an important risk factor for serious postoperative complications, including~     perioperative death. While OSA is increasingly recognized as a serious perioperative~     concern, current clinical practices are highly inconsistent with regard to the management of~     surgical patients with OSA. Additionally, the relative safety of intrathecal opioids in this~     patient population remains unknown.~   "
96729|NCT01790958|"~     Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve~     retinal function.~   "
96730|NCT01790945|"~     The purpose of this study is explore if a partnership and screening program put in place~     between a busy retina practice and their referring diabetes care offices can improve~     diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control~     in patients with diabetic eye disease.~   "
96731|NCT01790932|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not yet approved BKM120 for use in patients,~     including people with your type of cancer.~      BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer~     growth. This drug has been used in experiments in the laboratory and information from these~     research studies suggests that BKM120 may help to prevent cancer cells from growing.~      In this research study, the investigators are looking to see if BKM120 works to stop breast~     cancer cells from growing.~   "
96732|NCT01790919|"~     Existing drug and talking therapies for major depressive disorder (MDD) fail to produce~     complete recovery. This study will determine if substantial improvements to one of the most~     promising therapies, cognitive therapy (CT), can be achieved by administering a carefully~     designed procedure to improve memory for the content of CT sessions. This is important~     because (a) memory deficits are common in MDD patients and (b) each CT therapy session~     typically covers a complex array of topics and various skills are taught.~   "
96733|NCT01790906|"~     To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and~     reduce the rate of all-cause mortality effectively and securely.~   "
96734|NCT01790893|"~     The purpose of this study is to monitor safety outcomes for patients being treated with~     intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed~     Ocular Histoplasmosis Syndrome.~   "
96735|NCT01790880|"~     The purpose of this study is to evaluate whether a computerized speech-language treatment~     delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing)~     results in improved written communication skills of study participants with aphasia (i.e.,~     difficulty with the comprehension and expression of spoken and written language).~   "
96736|NCT01789840|"~     The purpose of this study is to evaluate improvement of symptoms from benign prostatic~     hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for~     prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional~     transurethral resection of the prostate (TURP).~   "
96737|NCT01789827|"~     This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients~     with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures,~     such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a~     scanner to make detailed pictures of areas inside the body and may be a less invasive way to~     check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99~     hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells~     and may be able to differentiate between tumor growth due to inflammation versus tumor~     progression in patients with stage IV melanoma receiving therapy.~   "
96998|NCT01787396|"~     The objective of this study is to evaluate efficacy and safety of initial combination~     therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in~     treatment naïve patients with type 2 diabetes, In other words, to proof superiority of~     initial combination therapy with Gemigliptin and Metformin than each monotherapy.~   "
96738|NCT01789814|"~     Early stent thrombosis has been noted with increased frequency in acute coronary syndrome~     (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with~     bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the~     delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable~     period of reduced antiplatelet effect in the immediate post stenting period. Combination~     therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of~     action of prasugrel could potentially significantly diminish the vulnerable period, likely~     reducing the potential for acute stent thrombosis. The trials which have documented the~     efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients~     in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most~     commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this~     study will examine the inhibition of platelet aggregation in patients randomized to~     treatment with clopidogrel vs prasugrel during the vulnerable period following the~     discontinuation of bivalirudin therapy. The investigators anticipate that this study will~     document significant enhancement of inhibition of platelet aggregation in patients~     randomized to prasugrel treatment.~   "
96739|NCT01789801|"~     Previous studies have demonstrated that an experienced ultrasound operator is able to~     efficiently perform radial arterial puncture on patients where an initial operator failed to~     puncture arteries via simple palpation.~      The objective of this study is to compare difficult-to-puncture patients randomized into~     two groups: one group where ultrasound is used to aid artery localisation, and one group~     where only palpation is used.~   "
96740|NCT01789788|"~     This randomized, double-blind, placebo-controlled, multiple ascending dose study will~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in~     patients with type 2 diabetes mellitus. Patients will be randomized to receive either~     RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the~     last dose of study drug.~   "
96741|NCT01789775|"~     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema~     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once~     daily is more efficacious than vehicle and provides an acceptable safety profile in the~     treatment of facial erythema associated with rosacea~   "
96742|NCT01789762|"~     This study is a multicentre, double-blind, randomized therapeutic trial.~      The primary objective of this study is to evaluate non-inferiority with regard to prevention~     and control of haemorrhage:~        -  of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA~          procedure)~        -  compared with the usual platelet concentrates (in additive solution intersol),~          reference arm, and~        -  compared with platelet concentrates re-suspended in autologous plasma (historic arm)~          These three products are available and authorised by ANSM (formerly AFSSAPS).~      The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and~     safety and the decreased frequency of grade 2 or higher side effects related to transfusion~     allergy to platelets.~   "
96743|NCT01789749|"~     The purpose is to investigate whether a simple additional treatment applied during~     colonoscopy (called 'soft' coagulation) can reduce the risk of recurrence of polyp at the~     area where the polyp was removed. After a large polyp is removed it is known that there is a~     20% chance that a small recurrence of polyp occurs at the site of removal can occur within 5~     months of the polyp being removed. This in theory will burn off tiny polyp tissue, which is~     usually not visible to the naked eye. This additional treatment may possibly reduce the risk~     of polyp recurrence.~   "
96744|NCT01789736|"~     In the double-masked, randomized, multi-center, active-controlled parallel study, patients~     will be randomized to receive either a fixed dose combination of AR-12286 and travoprost,~     AR-12286, or travoprost. The hypothesis is that there is no difference between each~     treatment arm.~   "
96745|NCT01789723|"~     The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent~     or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.~   "
96746|NCT01789710|"~     The purpose of this study is to examine the effectiveness of an internet-based contingency~     management program for smoking cessation in persons who are homeless. Thirty homeless~     smokers will be enrolled in the study. Participants will receive payment based on their own~     low carbon monoxide readings, which indicate being quit from smoking. Participants will be~     prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All~     participants will receive a four sessions of smoking cessation counseling, and will be~     trained to perform carbon monoxide monitoring with a device provided by the study. They will~     also be provided with a mobile phone equipped with a video camera, and will use this~     equipment at home to monitor their carbon monoxide . Participants will record videos of~     themselves taking a carbon monoxide reading and displaying the results, and will upload the~     videos to a secured website that is only accessible by the research team members and the~     participant. Payment will be based on providing carbon monoxide readings that indicate~     abstinence.~      The study is designed to address the following aims:~      Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency~     management for helping smokers who are homeless stop smoking.~      Specific Aim 2: To evaluate how effective internet-based contingency managementis on~     decreasing smoking in smokers who are homeless.~   "
96747|NCT01789697|"~     The objectives of this double-blind, randomized, controlled study are to evaluate the~     efficacy of maintaining contact with low-back pain patients through text messaging and~     emailing, to decrease anxiety levels, pain, number of follow-up visits through text~     messaging and emailing, and to improve reporting of surgical site infection after spine~     surgery through text messaging and emailing. The outcomes that will be measured are anxiety,~     pain, follow-up visits and received phone calls, and reporting signs of surgical site~     infection. Participants will include Dr. Oren Gottfried's patients who underwent spine~     surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after~     determination that the patient is going to undergo spinal surgery. All patients meeting~     inclusion criteria will be approached to participate irrespective of race or ethnicity. A~     total of 194 subjects will be recruited.~   "
96999|NCT01787383|"~     The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen~     compared to a sequential treatment regimen when two separate areas with AKs (one located on~     face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate~     gel~   "
96748|NCT01789684|"~     RATIONALE: Multi-faceted provider education and decision support intervention will increase~     the rate of appropriate referral of breast cancer patients at increased risk for hereditary~     breast and ovarian cancer (HBOC) to genetic counseling.~      PURPOSE: This cluster randomized controlled trial will compare active and passive~     interventions to increase the rate of appropriate genetic counseling referrals of newly~     diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the~     community oncology setting.~   "
96749|NCT01789671|"~     To evaluate the acceptability and feasibility of peers as interventionists in delivering~     family-based behavioral pediatric weight control intervention.~   "
96750|NCT01789658|"~     Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and~     conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this~     study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing~     HSCT.~   "
96751|NCT01789645|"~     It is a randomized clinical trial comparing surgical and conservative (physical therapy)~     treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to~     determine the efficacy of physical therapy versus endoscopic surgery in pain and disability~     in women with carpal tunnel syndrome at medium and long-term follow-up periods. We~     hypothesized that proper physical therapy approach can be equally effective than surgical~     intervention for improving pain and function in patients with carpal tunnel syndrome.~   "
96752|NCT01789632|"~     This Pilot study is a Multicenter, Randomized Trial comparing autologous platelet rich~     plasma (PRP) versus autologous whole blood versus dry needle tendon fenestration on pain and~     quality of life in patients with lateral epicondylitis (tennis elbow). We want to find out~     if pain and mobility are improved in people who receive an injection of PRP compared to a~     group of people who receive an injection of whole blood, a group treated with dry needle~     tendon fenestration and a group of people who receive no injection.~   "
96753|NCT01790854|"~     Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to~     12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce~     the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin~     followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline~     (after 60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at~     10 or 5 mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA)~     test to evaluate residual platelet reactivity (pharmacodynamic effects).~   "
96754|NCT01790841|"~     The purpose of the study is to proof the safety and efficacy of the new ICD sytem~     (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is~     set on the ICD system with DF4 connection.~   "
96755|NCT01790828|"~     This study is to describe the safety and efficacy of Xyntha® during the usual care setting.~   "
96756|NCT01790815|"~     PRIMARY OBJECTIVE :~      To determine whether mothers, given minimal group training, are capable of using a MUAC~     (mid-upper arm circumference) bracelet to screen their children for malnutrition and~     categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow'~     (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)~      SECONDARY OBJECTIVES :~      To establish whether there is a difference in the MUAC value if measured on the right arm as~     opposed to the left, in young children~      To determine whether there is a difference in the MUAC value if the mid upper arm position~     is determined visually as opposed to being measured in the 'classical' fashion~   "
96757|NCT01790802|"~     The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the~     progression to advanced age-related macular degeneration.~   "
96758|NCT01790789|"~     The purpose of this study is to investigate the effects of a stress reduction program on the~     quality of life of ovarian cancer patients during primary adjuvant chemotherapy.~   "
96759|NCT01790776|"~     Conventional urethrography is the standard diagnostic evaluation for patients with a~     suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV.~     Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic~     accuracy of sono-urethrography is equal compared to conventional urethrography, with even a~     better measurement of stricture length and degree of spongiofibrosis with~     sono-urethrography. However, sono-urethrography remained underused among urologists and~     radiologists.~      Patients will be randomly assigned into two groups:~      Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography~     is inconclusive or of poor quality, a conventional urethrography will be performed.~      The radiation dose in the two groups will be measured. The stricture length and location~     will be recorded and compared with the perioperative findings in order to evaluate the~     diagnostic accuracy. The complications of the procedure(s) will be recorded with a~     questionnaire directly after and two weeks after the conventional or sono-urethrography.~   "
96760|NCT01790763|"~     The purpose of this study is to determine the extent to which Keramatrix dressing promotes~     the healing of second-degree burn wounds in pediatric patients.~   "
96761|NCT01790750|"~     This is a single-center, feasibility study involving all neonates admitted to the neonatal~     intensive care unit with orders for a cardiac echo evaluation. Parents will be approached~     and provided a description of the study. No written consent will be requested, but parents~     have the option of opting out. Each patient will have a 5 minute Pocket echocardiography~     system scan followed by a full echo performed on a traditional full featured echo system.~     The objective is to assess if the current Food and Drug administration (FDA) approved Pocket~     echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as~     comparable to traditional full featured echo systems (FFES) and/or physical exam alone.~   "
96762|NCT01790737|"~     The purpose of this study is to determinate the efficacy and safety of the 3-drug induction~     treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized~     autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide~     maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized~     mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 +~     Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy,~     costs and safety.~   "
96763|NCT01790724|"~     The propose of the study is to test the hypothesis that an eight week program consisting of~     walking exercise and social cognitive theory based group workshops will increase physical~     activity adherence six months later in older adults with type 2 diabetes or metabolic~     syndrome.~   "
96765|NCT01790698|"~     This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing~     fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with~     high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and~     adequate interventions in order to salvage lives and limbs. However, diagnosis and~     management are difficult due to heterogeneity in clinical presentation, in co-morbidities~     and in microbiological aetiology. Thus, there is an urgent need for novel diagnostics and~     therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic~     features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host~     and bacterial disease traits and their underlying interaction network) is required for an~     improved diagnosis and management of NSTIs. The current proposal is designed to obtain such~     insights through an integrated systems biology approach in patients and experimental models.~     The project is based on a prospective NSTI patients cohort including a clinical registry to~     document clinical data and treatment strategies, combined with an isolate and biobank~     collection. The samples will be analyzed through advanced bioinformatics and computational~     modelling work flow to identify and quantify pathogen signatures and underlying networks~     that contribute to disease outcome. One aim is to translate clinical and systems biology~     data into development of novel diagnostics.~   "
96766|NCT01790685|"~     To measure the pro-permeability factors in the aqueous humor of patients with~     persistent/recurrent macular edema after an injection of Ozurdex.~   "
96767|NCT01790672|"~     The study is aimed at establishing the contribution of wine components on hydroxytyrosol~     body concentrations and biological effects.~   "
96768|NCT01790659|"~     This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing~     the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in~     subjects with CL in Panama. The primary objective of this study is to determine if WR~     279,396 results in statistically superior final clinical cure rates of an index lesion when~     compared with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L~     panamensis.~   "
96769|NCT01790646|"~     Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its~     learning curve was prooved on manikin but not in adult patients.~   "
96770|NCT01790633|"~     This is a pilot, monocentric, prospective, randomized control trial looking at the use of~     rapid tests as a part of normal care. The investigators will be testing for hepatitis B~     virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will~     be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation~     from the organization Médecin du Monde (CASO, MDM).~      Infection status of participants will be determined by either the standard test (ELISA) or~     rapid test. The choice between tests will be determined randomly.~      The overall goal is to determine the general acceptability and feasibility of rapid tests~     and to see if they can help individuals increase their awareness of infection status when~     compared to longer, routine methods of testing. In addition, results from these tests will~     allow the medical doctor to guide participants to appropriate care. All positive tests will~     be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and~     health-specific information will be obtained four months after testing.~   "
96771|NCT01790620|"~     Severe septic patients with acute kidney injury (AKI) requiring continuous renal replacement~     therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine~     liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with~     continuous venovenous hemofiltration (CVVH) presents frequent complications, known as~     dialytrauma, and a high resource cost both technical and human. The study primary~     end-point is to demonstrate a non-inferiority survival of continuous venovenous hemodialysis~     (CVVHD) plus an adsorption membrane respect to CVVH plus an adsorption membrane. As~     secondary end-points investigators will try to demonstrate immunomodulation and technical~     superiority of CVVHD respect to CVVH. In order to achieve these objectives investigators~     have designed a randomized controlled trial that will include those patients whom present~     severe sepsis and AKI meeting CRRT initiation criteria. During the first 72 hours~     investigators will measure plasmatic elimination capacity of main cytokines,~     lipopolysaccharide (LPS), and other clinical and prognostic relevant molecules.~     Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse~     effects related to CRRT (dialytrauma) will also be registrated. Finally, investigators~     will analyze 90 days survival. Demonstration of a non inferiority survival added to a~     superior immunomodulating capacity and a minor complication rate with its consequent lower~     cost, should settle the based evidence principles that recommend the use of CVVHD asociated~     to an adsorption membrane in severe septic patients with AKI whom need CRRT.~   "
96772|NCT01790607|"~     To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects~     with the hepatic impairment and matched healthy subjects.~   "
96773|NCT01790594|"~     The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the~     amount of other anti-rejection medications necessary and thereby reduce the long-term side~     effects caused by the other medications. The researchers also want to learn more about the~     safety of this treatment and long term health of transplanted pancreases and kidneys.~   "
96781|NCT01790490|"~     Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to~     cocaine cues, that may be responsive to pharmacological modulation of glutamatergic~     circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr)~     modulators, studies with human subjects have been unsuccessful to date. The purpose of this~     investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to~     have potent therapeutic effects in humans, on cue-induced craving and impaired motivation~     for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.~   "
96782|NCT01790477|"~     The goal of this study is to assess the role of battlefield acupuncture in the reduction of~     pain scores status post adult tonsillectomy. Secondary goals of this study include reduction~     in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend~     an increased risk of worsening pain or improved response with acupuncture.~   "
97000|NCT01787370|"~     The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the~     measurement of endothelial function using flow-mediated dilation and flow-mediated~     constriction provides on the presence of coronary atherosclerosis and on the prognosis of~     patients undergoing coronary angiography.~   "
96774|NCT01790581|"~     Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains~     and other residual impairments. CAI has been linked to many different causative factors~     including sensory and motor deficits that affect the global function of the sensorimotor~     system as well as the patient. Over the past 20 years, strong evidence has been generated to~     support balance training as an effective intervention strategy in the CAI population.~     Unfortunately, most investigations have focused solely on maximizing motor output through~     balance training, while ignoring the full spectrum of sensorimotor dysfunction associated~     with CAI. There may be advantageous sensory-targeted interventions that augment the effects~     of balance training and lead to greater enhancements of functional outcomes for CAI.~     However, this possibility has not been systematically explored. Sensory-targeted ankle~     rehabilitation strategies (STARS), such as joint mobilization and plantar massage have~     resulted in improved sensorimotor function in those with CAI. However, only a single STARS~     (i.e. stochastic resonance) has been investigated in combination with balance training.~     While the combined effects were greater than those of balance training alone, stochastic~     resonance requires relatively expensive equipment that is not commercially available. Thus,~     the purpose of this investigation is to test the hypothesis that combining low cost STARS~     (e.g. plantar massage and joint mobilizations) with balance training will result in greater~     sensorimotor and functional improvements in those with CAI than balance training alone.~   "
96775|NCT01790568|"~     This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After~     completing enrollment of the planned 12 subjects, we are extending the study to an~     additional 25 subjects. The trial will examine the safety and efficacy of the addition of~     vorinostat, the study drug, to standard medications to try to prevent or lower the risk of~     graft versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or~     marrow stem cell transplants. The transplant regimens, chosen according to current~     institutional policy, will depend upon the recipient's underlying disease (their blood~     cancer or other blood disorder), previous therapy, and current health issues. GVHD~     prophylaxis (preventive drug intervention) will be the local institutional standard for~     post-transplant immunosuppression, including tacrolimus and methotrexate, plus vorinostat.~     Vorinostat will be given twice daily orally beginning 10 days prior to the recipient's~     transplant and continue for up to 100 days after transplant.~   "
96776|NCT01790555|"~     Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay,~     lower costs and higher patient satisfaction. In its treatment, frequent use is made of~     opioids. However, opioids have many side-effects. A possible add-on can be sought in THC,~     which has been shown to have possible analgesic and/or pain modulating effects in~     preclinical research. The purpose of this study is to investigate the analgesic and pain~     modulating effects of perioperative Namisol, a tablet containing THC, in patients that will~     undergo major abdominal surgery.~   "
96777|NCT01790542|"~     With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6~     months of age there has arisen concern about what is the best solid food to introduce at~     that time. Traditionally solids were introduced in Canada at 4-6 months and usually~     iron-fortified rice cereal was the first food of choice. New recommendations from Health~     Canada include meat as a potential first food as well as other iron fortified foods. This~     has lead to uncertainty of both public health officials and parents about the optimal~     introduction and choice of solids after exclusive breastfeeding.~      In addition to meeting iron needs with the first solid food choice, the investigators are~     concerned about the possible generation of reactive oxygen species (ROS) in the gut of the~     infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron~     per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that~     most of the residual iron enters the colon. Normally excess iron is sequestered by a variety~     of mechanisms in the body, but there is no such system for the sequestering of iron in the~     gut lumen. The investigators have shown that providing iron supplements to adults where the~     majority of the iron is unabsorbed passes through the digestive tract can lead to the~     generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day~     supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will~     receive the same dose and are likely producing ROS in their digestive tract. This may cause~     inflammation and make infants more susceptible to disease. The investigators think that~     meats and infant cereals with phenolic antioxidants available from fruits will likely reduce~     the generation of ROS in vivo. Therefore the investigators wish to determine if traditional~     and newly recommended first foods are safe from a free radical and inflammatory perspective.~      HYPOTHESES:~        1. Consumption of infant cereals with iron will increase ROS generation in the gut~        2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut~        3. Consumption of meat will not generate ROS~        4. Consumption of iron fortified cereals or meat will maintain iron status during infancy~   "
96778|NCT01790529|"~     Surgical site infections (SSI) are the most frequent hospital acquired infections in~     patients who underwent surgery. With regards to the increasing financial restraint in~     patient care, the socio-economic burden of SSI in the public health sector and its~     prevention gains in importance.~      The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior~     to the skin incision significantly reduces the risk of SSI, but the correct time point of~     drug administration remains unclear. Most studies recommend application of SAP directly~     prior to skin incision. Other studies, however, suggest that this is too late and more time~     between administration of the SAP and skin incision is necessary for optimal SSI prevention.~     A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30~     minutes prior to skin incision.~      Due to the obvious importance of this controversy, we want to answer this question with a~     clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and~     the Cantonal Hospital of Aarau. We plan to investigate two administration strategies~     according to the timing of the SAP. Strategy A will consist of SAP application in the~     anesthetic room located in front of the actual operating theatre, where the patient gets~     anesthesia. Therefore, the application of SAP will take place early, approximately between~     75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating~     theatre, which on average occurs later (approximately within the last 30 minutes before skin~     incision).~      We test the hypothesis that strategy A is more effective in preventing SSI than strategy B.~     We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at~     each study site and 2500 per study group). All patients will be followed in the hospital for~     SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital~     discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such~     as hip endoprosthesis or meshes). We expect this study to be completed within approximately~     3 years.~   "
96779|NCT01790516|"~     This study is for patients with newly diagnosed head and neck cancer that cannot be removed~     by surgery.~      The purpose of this study is to determine the feasibility of using genetic variations in~     patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab~     (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with~     radiation therapy. In this study the investigators will test whether genetic differences~     between patients can be used to pick which of these two drugs a patient should receive. All~     patients will have a blood sample drawn that will be tested for genetic differences. If~     patients have genetic differences that correlate with a better outcome from cisplatin they~     will receive cisplatin with radiation. If patients have genetic differences that do not~     correlate with a better outcome from cisplatin they will receive cetuximab with their~     radiation therapy.~   "
96780|NCT01790503|"~     The study objectives are to assess the potential for PLX3397 to improve the efficacy of~     standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed~     glioblastoma (GBM).~   "
96783|NCT01790464|"~     Endotracheal intubation of the morbidly obese is often performed awake. This is performed~     after topical anesthesia of the patient's pharynx and larynx. There are many techniques used~     to perform topical anesthesia of the patient's airway, which include aerosolization of local~     anesthesia, topical application of local anesthesia, and nerve blockade using needles and~     local anesthesia. Reasons for failure of any awake tracheal intubation technique is excess~     gagging. The most effective method to adequately anesthetize the airway to decrease the~     amount of gagging is unknown. The investigators wish to assess if the instillation of local~     anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of~     gagging episodes during awake video laryngoscopy assisted tracheal intubation of the~     morbidly obese.~   "
96784|NCT01790451|"~     Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a~     radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure~     approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using~     similar planning criteria, procedure protocol, instruments and software used for~     brachytherapy, a conventional targeted radiation therapy where radioactive seeds are~     implanted into prostate tumours. Patients will have an ultrasound of the prostate and the~     imaging data will be entered into the Planning Software system. The volume of the prostate~     is measured and a specified ablation zone will be determined. The IRE will be performed~     under general anaesthetic and the specified zone identified in the planning stage will be~     ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image~     guidance. When the needles are in place, electric pulses of one to two minutes duration are~     used to ablate the specified zone. The total procedure time will be approximately 1 hour.~     Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE,~     pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data~     collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic~     Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The~     patients will have their scheduled prostatectomy at approximately 30 days after the IRE~     procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control~     MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological~     examination of the prostate by the Pathology Department and measured as complete or~     incomplete ablation.~      The primary outcome is safety as measured by the composite of procedural device and post~     procedural adverse events, measured with the Common Terminology Criteria for Adverse Events~     v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate~     Symptom Score (IPSS) or required catheterization time and International Index of Erectile~     Function (IIEF) and efficacy of ablation determined by histological examination post~     prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by~     patient satisfaction questionnaire, post procedural pain management and Visual Analogue~     Scale (VAS) pain score, time to ambulation, length of hospital stay.~   "
96785|NCT01790438|"~     The purpose of this study is to compare LY2605541 and human insulin NPH using the following~     measures for participants treated for up to 26 weeks:~        -  Change in participants' overall blood sugar control~        -  The number of night time low blood sugar episodes~        -  The number of participants that reach blood sugar targets without low night time blood~          sugar episodes~        -  The total number of low blood sugar episodes reported~   "
96786|NCT01790425|"~     This is a prospective , single center, investigator initiated, randomized controlled trial~     to compare two methods of performing colonoscopy by experienced colonoscopist. Potential~     female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study~     option and will be enrolled if they sign the informed consent.~      In recent years, the water infusion method has been reported to have several beneficial~     effects when studied in veteran patients. These include: significant reduction in discomfort~     to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled~     unsedated colonoscopy, lower sedation medication requirement when they accepted the option~     of minimal pre-medication sedation, more patients completing without sedation (78% vs 54%)~     when they accepted the on demand sedation and an increase in the yield of adenomas (a type~     of cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the~     method have repeatedly called for studies using the method in female patients to confirm or~     refute the findings as most of the veteran patients are male patients.~   "
96787|NCT01790412|"~     To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic~     activities) aerobic and muscular tonification, on control to the prevention to Gestational~     Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.~   "
96788|NCT01790399|"~     The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in~     addition to the usual method (blue and /or radioactive product). This is a feasibility study~   "
96789|NCT01790386|"~     This study is being performed to obtain data about the CORA system, a new device that is~     currently being tested and is not yet cleared for sale in the United State by the Food and~     Drug Administration (FDA). The purpose of the study is to validate the CORA system by~     comparing the results of this test to that of the standard of care device called the TEG~     system. Both systems evaluate hemostasis, a highly complex and interactive process involving~     many protein and cellular elements, especially platelets, occurring in a series of~     interrelated phases, which results in either normal hemostasis or a tendency toward bleeding~     or clotting complications.~   "
96790|NCT01790373|"~     The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative~     intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple~     intervention studies by our team in Rakai and Masaka Districts of southern Uganda with~     AIDS-orphaned adolescents have revealed that if given an opportunity to participate in~     economic empowerment interventions, youth and their caregivers take full advantage of these~     interventions to save and invest in their future, show improvements in family financial~     outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental~     health. The Suubi+Adherence study capitalizes on this prior work, positing that economic~     empowerment may be a missing, yet critical ingredient to HIV treatment adherence~     interventions for adolescents and young people. Suubi+Adherence incorporates an economic~     empowerment design, with a savings-led income generating component, to promote economic~     stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents~     in a region of southern Uganda with the highest HIV incidence and prevalence in the country.~   "
96791|NCT01790360|"~     The study will seek and recruit substance-using Black Men who have Sex with Men (MSM) in New~     York City for Human Immunodeficiency Virus (HIV) testing and will link and retain those who~     are HIV infected in HIV primary care. The STAR study has two primary objectives: to evaluate~     the feasibility and effectiveness of Respondent Driven Sampling (RDS) in the substance using~     Black MSM population for identifying individuals who are HIV infected and not in care; and~     to assess the relative effectiveness of patient navigation and financial incentives in~     linkage and retention to HIV care.~   "
96792|NCT01790347|"~     An estimated two-thirds to three- quarters of women experience gestational weight gain~     outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and~     15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with~     several maternal and fetal complications..~   "
96793|NCT01790334|"~     It is widely known that positive mechanical ventilation increases the positive intrathoracic~     pressure which affects the pressure in the RIJV, resulting in an increase of the CSA.~     Currently, there appears to be a lack of studies in the literature that assess the effects~     of different modes of ventilation of this increase.~      The aim of our study is to evaluate the changes in cross-sectional area and diameters of~     RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous~     ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography~     and to determine the ventilation mode that is most suitable for catheterization.~   "
96794|NCT01790321|"~     The general objective of this study is to determine the effect of the daily consumption of~     zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school~     age children from rural areas characterized by a high risk of zinc deficiency and by~     elevated stunting prevalence.~   "
96795|NCT01790308|"~     The purpose of this study is to investigate and evaluate the effects of liraglutide combined~     with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control~     and β-cell function in newly diagnosed type 2 diabetic patients.~   "
96796|NCT01790295|"~     The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior~     to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing~     another person's hematopoietic stem cells (bone marrow transplantation) will be successful~     in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera~     myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF),~     collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue~     develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring.~     This study plans to evaluate whether adding the drug Ruxolitinib will further aid in~     reducing pre-transplant spleen size, improve physical performance levels and reduce adverse~     events (side effects) related to the transplant. Ruxolitinib is a drug that is approved by~     the FDA for the treatment of patients with advanced forms of myelofibrosis. Using~     Ruxolitinib prior to stem cell transplantation is experimental.~   "
96797|NCT01790282|"~     Study if supporting luteal phase of high responder (high egg production or high Estradiol~     level) long Gn_Rh agonist protocol ICSI/IVF cycle by combined Estradiol and progesterone~     impairs or improves outcome in terms of pregnancy and implanation rates.~   "
96798|NCT01790269|"~     Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on~     fingolimod treated kidney transplant patients showed that NK cells were not influenced in~     any of the treatment groups. However, more recent reports indicate an increased frequency of~     NK cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative~     reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been~     demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors~     seems to increase during NK cell maturation. Thus, different NK cell sub-types may response~     differently to S1P-receptor agonist such as fingolimod.~      Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the~     effects of fingolimod on NK cell maturation/differentiation.~   "
96799|NCT01790256|"~     Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep~     System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia~     patients. The current study is a two dose study to determine the optimal temperature for the~     Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and~     sleep efficiency.~   "
96800|NCT01790243|"~     The purpose of the study is to collect additional safety and efficacy information on the~     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the~     femoral and popliteal arteries.~   "
96801|NCT01790230|"~     A preliminary Study in Subjects Undergoing Low Anterior Resection~   "
96802|NCT01790217|"~     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in~     first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive~     non-small cell lung cancer. Eligible patients, for whom the treating physician has decided~     to initiate treatment with Tarceva according to the local label will be followed for 18~     months.~   "
96803|NCT01790204|"~     The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate~     (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The~     p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or~     anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions~     of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed~     clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since~     the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral~     cells will contain measurable levels of mutant p53. The participants will consume watercress~     juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed~     PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our~     hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53~     within the oral cells. This depletion could lead to a possible clinical application of this~     compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.~   "
96804|NCT01790191|"~     This study aims at comparing learning mechanisms to increase vegetable acceptance in infants~     at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and~     flavor-nutrient learning (FNL); measuring the stability of the learning effect; and~     examining the impact of infants' feeding history on vegetable acceptance.~   "
96805|NCT01790178|"~     The objective of the proposed study is to evaluate the clinical utility of muscle~     ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our~     facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years~     old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle~     biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of~     this test is important.~   "
96806|NCT01790165|"~     The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a~     clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet~     with that of with TDT 067 under maximal use conditions.~      Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are~     significantly lower plasma levels of terbinafine and its major metabolites after a topical~     administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil®~     tablet.~   "
96809|NCT01790126|"~     The proposed clinical trial will study the effects of 12 months of therapy with ARN-509~     alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in~     men with a rapidly rising serum PSA after prior definitive local therapy for prostate~     cancer. The endpoints selected reflect measurable short term effects of androgen deprivation~     therapy (ADT), including quality of life and several metabolic parameters. In addition, the~     relative effect of each treatment strategy on PSA suppression as well as testosterone~     recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.~   "
96810|NCT01790113|"~     A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of~     Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a~     degenerative joint disease.~   "
96811|NCT01790100|"~     The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally~     administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C~     infection.~   "
96812|NCT01790087|"~     This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the~     effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac~     repolarization, specifically, Fridericia's QT-Interval (QTcF)~   "
96813|NCT01790074|"~     It is a pilot randomized controlled trial comparing real and simulated manual treatment of~     trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the~     current randomized clinical pilot trial was to determine the preliminary effects of TrP~     manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as~     compared to manual contact over the muscle tissues.~   "
96814|NCT01790061|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles~     in the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria and inflammatory bowel diseases~     (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile~     colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases,~     irritable bowel syndrome (IBS) and constipation have also met with some success. This is an~     initial step into investigating the potential efficacy of standardized fecal bacteriotherapy~     through mid-gut (at least below duodenal papilla) for UC, the investigators propose to~     determine the efficiency and safety of FMT in a series of 60 patients with moderate to~     severe UC (Montreal classification).~   "
96815|NCT01790048|"~     This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial~     of two supplementary foods in the treatment of MAM.~      Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF,~     in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary~     feeding program.~      Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will~     differ by no more than three percent.~   "
96816|NCT01790035|"~     Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing~     acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety~     lead-in.~   "
96817|NCT01790022|"~     In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain,~     stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be~     investigated. It is expected, that a single dose of methylprednisolone 500 mg given~     intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can~     be seen already 2 weeks after drug administration.~   "
96818|NCT01790009|"~     Accumulating evidence suggests that regular consumption of foods and beverages rich in~     flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several~     well-controlled randomised human intervention studies have shown that cocoa flavanols have~     beneficial effects on blood pressure, endothelial function and other biomarkers of~     cardiovascular health. These vascular improvements have been correlated in time with changes~     in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore~     likely dependent on changes in their absorption, distribution, metabolism and excretion~     (ADME). Recent studies have provided detailed information regarding the absorption and~     metabolism of cocoa flavanols. However, there is a lack of information on whether there are~     changes in flavanol absorption and metabolism with increasing age.~   "
96819|NCT01789996|"~     2-4 6MWT performed but with alternative wording and coaching in random order to determine~     differences in outcomes.~   "
96820|NCT01789983|"~     The study will look at conducting a medium-intense walking program called Walk With Ease~     with cancer patients age 60 and above who are starting chemotherapy treatment. We will~     measure how many of these patients complete their participation in this program.~   "
96821|NCT01789970|"~     The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate~     extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in~     alleviating moderate to severe pain in patients with chronic low back pain. Patients may be~     opioid-naïve or opioid-experienced.~   "
96822|NCT01789957|"~     This multicenter, open-label extension study of Protocol 2993-112 is designed to assess~     long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate~     long-term safety and tolerability in subjects treated with metformin who receive~     subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing~     Protocol 2993-112 are eligible to enroll.~   "
96823|NCT01789944|"~     To evaluate the acceptability and feasibility of peers as interventionists in delivering~     family-based behavioral pediatric weight control intervention.~   "
96824|NCT01789931|"~     CB (Chemical Biological)protective clothing provides a thermal resistance between the human~     body and its environment. CB protective clothing will be essential for combat soldiers in~     case of non conventional attacks. Lifebeam developed a new non invasive sensor for body~     core temperature detection. The research purpose is to evaluate the Lifebeam sensor during~     heat tolerance test while wearing CB protective clothing.~   "
96825|NCT01789918|"~     The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to~     include up to one hundred (100) eligible patients as defined within the clinical~     investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally~     designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.~   "
96826|NCT01789905|"~     To retrospectively collect the effectiveness and safety information of tigecycline related~     to their appropriate use in daily practice.~   "
96828|NCT01789879|"~     The use of hormone contraception poses a significant challenge for the estimated 16 million~     HIV-infected women of childbearing age. This is due to known drug interactions with~     antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception~     effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel~     subdermal implant, the most widely available hormone implant in low and middle-income~     countries, this study will translate its findings into an evidence-based approach to~     co-manage these important medications. The investigators hypothesize that women receiving~     nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the~     mean levonorgestrel plasma concentration measured six months after the implant's insertion~     as compared to those women who are not taking antiretroviral therapy. Although the implant's~     efficacy may be retained initially, the investigators propose that a decrease in~     levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the~     implant's effectiveness near the end of its intended duration of use (5 years).~   "
96829|NCT01789866|"~     Studies suggest that lutein and n-3 fatty acids may influence the development of a child's~     brain and may be related to how well children learn. Both lutein and the n-3 fats (also~     known as omega-3 fats) are not made by the body and must be obtained in the diet. The~     investigators are interested to understand the importance of n-3 fats and lutein to child~     brain development. Functional magnetic resonance imaging (fMRI) will make it possible to~     look into the brain from the outside and see which parts of the brain are being used as~     children complete working memory tasks. The investigators will study brain function using~     fMRI among children with different intakes of n-3 fats and lutein.~      Hypothesis:~        1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show~          poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and >~          1,200 μg/day lutein.~        2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences~          in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day~          lutein.~   "
96830|NCT01789853|"~     The purpose of this study is to demonstrate the efficacy of intensive locomotor~     interventions early post stroke. An intensive locomotor training (LT) program will be~     compared to an active control, conventional physical therapy. It is proposed that an early~     and intensive stepping paradigm that is not typically employed early in physical therapy~     will lead to superior outcomes and improved community mobility. A randomized, blinded,~     controlled trial will test subjects with moderate to severe locomotor dysfunction in~     individuals post-stroke to compare walking-related outcomes after intensive gait training~     (including treadmill, overground, stair training, and skilled walking training) to outcomes~     after conventional physical therapy.~   "
96831|NCT01789619|"~     To evaluate the clinical efficacy of the extended release formulation of tacrolimus~     (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately~     with cyclosporine A because of side effects and/or non-responsiveness.~   "
96832|NCT01789606|"~     A self-selection and actual use trial to evaluate the extent to which consumers will~     appropriately select and use the 600 mg immediate release/extended release caplets and~     comply with dosing instructions.~   "
96833|NCT01789593|"~     This trial is conducted in Europe. The aim of the trial is to compare cognitive function and~     associated brain activation patterns during an acute hypoglycaemic episode and during~     euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess~     cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively,~     in subjects with type 1 diabetes.~   "
96834|NCT01789580|"~     Prevalence of problem gambling is estimated about 1-3% of the general adult population. This~     percentage increases to 5% when talking about online gambling. In France, the market for~     online gambling was recently opened up to competition and regulation (May 2010), including~     poker and sports/horse races betting, but excluding for the moment casino games. Recent~     international studies show that legalizing online gambling led to an increase of practices,~     including problem gambling.~      In France, the law stipulates the establishment of moderators of online gambling, to prevent~     excessive gambling practices. The Regulatory Authority of Online Games (ARJEL) guarantees~     the implementation of these moderators. However, no evaluation of the effectiveness of these~     moderators is planned.~      Therefore the investigators propose to conduct an experimental study about online gambling.~     The objective will be to evaluate the effectiveness of four kinds of moderators, some~     already legislated, but not evaluated, and others offered by the investigators team.~     Proposals for amending legislation will be made according the results of this study.~   "
96835|NCT01789567|"~     To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve~     Implantation System via direct aortic approach.~   "
96836|NCT01789554|"~     Death from cardiac disease is one of the most common causes of death in the western world.~     The majority of these deaths takes place outside hospital as sudden cardiac death. However,~     with immediate (within minutes) actions such as cardiopulmonary resuscitation (CPR) and~     defibrillation many lives would be saved. CPR is a key factor to increase survival from Out~     of Hospital Cardiac Arrest (OHCA). CPR buys time by supporting the brain with some~     circulation in waiting for a defibrillator that can restart the heart. In Sweden about 2,5~     million people are trained in CPR. However, only about half of all OHCA victims will get CPR~     in waiting for ambulance arrival.~      The aims of the Response to Urgent Mobile message for Bystander Activation (RUMBA) trial is~     to try a new way of logistics to increase bystander CPR by recruiting lay volunteers to~     nearby OHCAs via their mobile phones.~      Hypothesis: By dispatching lay volunteers to nearby OHCAs with mobile phone technology~     bystander CPR may increase from 50% to 62,5 %~   "
96851|NCT01789359|"~     Essentially all of the published data on anthocyanin absorption in humans are from short~     term studies - a few days or less, most typically 24 h. However human studies demonstrating~     clinical effects are typically conducted for several weeks or even months. To examine how~     anthocyanin absorption and metabolism may be affected this study will examine urinary~     excretion of anthocyanins over one month, followed by a one week washout, and then one more~     dose of blueberry juice.~   "
96852|NCT01789346|"~     The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium~     titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the~     treatment of fresh surgical scars.~   "
96837|NCT01789541|"~     Overt hyperthyroidism (so-called goiter in lay language) is a hormonal disturbance that is~     known to increase the risk of atrial fibrillation (a common heart arrhythmia with~     potentially severe consequences) in some patients. Previous research has indicated that even~     slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may~     increase this risk. When atrial fibrillation and overt hyperthyroidism are found~     simultaneously in a patient, the hormonal imbalance must be treated first in order to later~     resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical~     hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in~     patients admitted for atrial fibrillation ablation than in the population as a whole, and 2)~     Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation~     than others.~      As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry~     Tachycardia at the same clinics as the cases. No correlation has ever been shown between~     AV-nodal Reentry Tachycardia and hyperthyroidism.~   "
96838|NCT01789528|"~     The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL~     on the intestinal flora of male and female healthy volunteers after multiple administrations~     over 7 days. An assessment of the effect on intestinal flora is an important aspect to~     understand for the safe clinical use of the investigational products and is expected by~     regulatory agencies.~   "
96839|NCT01789515|"~     In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is~     common to create a diverting stoma at the same procedure. Several studies have shown that~     ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and~     postoperative complications after major colorectal surgery. The aim of this study is to~     evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects~     postoperative morbidity in patients treated within an ERAS program.~   "
96840|NCT01789502|"~     This study is a prospective, randomized study to compare of outcome of fully covered metal~     stents with that of plastic stents for preoperative biliary drainage in distal common bile~     duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of~     stent-related adverse events, the re-intervention rate, the effectiveness of biliary~     drainage, surgical outcomes and hospital stays.~   "
96841|NCT01789489|"~     To prove that the 3 dimensional sonohysterography is, at least, as effective as the~     diagnostic hysteroscopy in examining the uterine cavity.~   "
96842|NCT01789476|"~     This is a single-center, randomized, double blind, placebo controlled, parallel group proof~     of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and~     pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.~   "
96843|NCT01789463|"~     Multicenter randomised study, on parallel groups to compare recovery of functional amplitude~     following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the~     other group.~   "
96844|NCT01789450|"~     The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar~     complex (NAC) prospectively due to the section of the dermis after decortication~     (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.~   "
96845|NCT01789437|"~     to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients~     with retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg~     (DEX) compared to a matched control group of normal eyes in non-hypertensive subjects.~   "
96846|NCT01789424|"~     Aim of this study is to evaluate swallowing functionality in patient sedated for~     gastroenteric endoscopic procedure.~      Swallowing will be study by laryngeal fibroscopy and evaluate using Penetration-Aspiration~     Scale and Aspiration Risk validated in scientific literature.~      Aim of the study is to describe swallowing, as an expression of airway protection, in~     sedated patient. in particular, our purpose is to determine the incidence of moderate-severe~     and severe swallowing alteration (level 3 or 4 of Aspiration Risk scale).~   "
96847|NCT01789411|"~     The AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and~     vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with~     genetic profile and novel circulating biomarkers. AtheroRemo-IVUS is a prospective,~     observational, cohort study of patients who underwent coronary catheterization for acute~     coronary syndrome or stable angina pectoris. Prior to the catheterization procedure, blood~     samples were drawn for biomarker measurements and genetic analyses. Subsequent to the~     catheterization procedure, intravascular ultrasound is performed in a non-culprit coronary~     artery. In patients who are also participating in the AtheroRemo-NIRS substudy,~     near-infrared spectroscopy is additionally performed in the same non-culprit vessel. Primary~     endpoint is the presence of vulnerable plaque as determined by intravascular ultrasound.~     Secondary endpoint is long-term incidence of major adverse cardiac events. Results from~     AtheroRemo-IVUS are expected to improve our knowledge on the role of genetic profile and~     inflammation in the development of atherosclerosis and vulnerable plaques. Furthermore,~     novel biomarkers and intracoronary imaging techniques will be validated in this study.~   "
96848|NCT01789398|"~     This is a multicentric international phase III, double blind randomized study assessing~     efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on~     to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS)~     during 8 weeks~   "
96849|NCT01789385|"~     Deep brain stimulation for the treatment of Parkinson's disease has unique surgical stages~     and anesthesia needs. In the first stage the electrodes are inserted in the targeted brain~     areas and in the second stage the pulse generator is implanted. The technique for~     establishing sedation and analgesia for functional neurosurgery may differ among~     institutions. In this study it was aimed to investigate our anesthesia methods,~     intra-operative adverse events in the first stage of deep brain stimulation and the post~     operative pain therapy of the patients.~   "
96850|NCT01789372|"~     The purpose of this study is to determinate if mediyoga has effects in quality of life,~     heart rate variability, blood pressure , heart rate in patients with paroxysmal atrial~     fibrillation (PAF).~   "
96866|NCT01789164|"~     The goal of this project is to determine if it is possible to assess Cerebrovascular~     Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a~     method would be particularly helpful in traumatic brain injury (TBI), where objective~     measures are needed, and would greatly expand the capacity to make such assessments in~     standard clinical practice.~   "
96853|NCT01789333|"~     The purpose of the study is to see if brighter lights will allow for shortening of the~     treatment time required to stabilize the eyes of patients with keratoconus or a bulging~     cornea. The investigators will be comparing the therapeutic effects of two different higher~     brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as~     bright as the other and the exposure time of these brighter lights to deliver equivalent~     energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes.~     Riboflavin is vitamin B2 and the investigators are trying to determine if an identical~     clinical effect can be achieved the brighter treatment lights are used for shorter times.~     The investigators will also monitor the clinical effect and the status of the cornea to see~     if additional risks are associated with the brighter light.~   "
96854|NCT01789320|"~     This study is designed to determine the safety and tolerability of a single microinjection~     of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who~     have non-infectious uveitis.~   "
96855|NCT01789307|"~     Lactose, one of the key nutrients in human milk may be critically important to infants for~     more reasons than being a source of energy. We are interested in understanding how lactose~     when compared to other sugars influences how nutrients, specifically macronutrients are~     handled after digestion and absorption. To date, there have been no studies looking at how~     fat and protein varies when lactose compared to other sugars is ingested. There may be~     metabolic advantages to considering lactose for nutrition support of premature infants~     rather than glucose or dextrose as is often used in intravenous feeds, or the corn syrup~     solids in lactose-free formulas. We hope the information from this study will provide new~     information on the unique aspects of lactose.~      Hypothesis: The hypothesis is that providing carbohydrate as lactose:~        1. minimizes the amount of carbohydrate that is converted into fat~        2. enables a relatively constant metabolic state throughout feeding interval that avoids~          swings of high to low insulin, glucose, and fats.~   "
96856|NCT01789294|"~     Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the~     clinical outcome of patients Methods.We recruited children who undergone diagnostic~     colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility~     criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment~     assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs~     mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and~     patch test for common foods, and symptoms scoring at baseline and follow up have been~     performed by blinded clinicians. Chi-square test for trend was used to compare the frequency~     of symptoms score improvement (>1 point) among groups. The association of baseline features~     of patients with the clinical response was estimated by frequency analysis.~   "
96857|NCT01789281|"~     Study to allow access to everolimus for patients who are on everolimus treatment in a~     Novartis-sponsored study and are benefiting from the treatment as judged by the investigator~   "
96858|NCT01789268|"~     This clinical study will investigate the relationships between sequential respiratory viral~     infections, patterns of intestinal and respiratory bacterial colonization, and adaptive~     cellular immune phenotypes which are associated with increased susceptibility to respiratory~     infections and long term respiratory morbidity in preterm and full term infants. This is a~     prospective, cohort study, enrolling at a single center via two sites (URMC and~     URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be~     accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150~     pre-term and 130 full-term.~   "
96859|NCT01789255|"~     This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate~     works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients~     with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an~     effective treatment for GVHD caused by a bone marrow transplant.~   "
96860|NCT01789242|"~     This is a dose finding study to evaluate the safety and determine the maximum tolerated dose~     of carfilzomib in patients with previously treated systemic light-chain amyloidosis.~   "
96861|NCT01789229|"~     Establishment of a tumor bank, consisting of tissue samples of tumor patients (benign and~     malign tumors) and healthy people as controls. The tissue samples will be collected~     systematically together with the corresponding clinical data. The biological samples, the~     clinical date together with prospective experimental date constitute the entity of the~     tissue tumor bank.~      This tumor bank for tissue samples, together with our tumorbank for blood samples~     (NCT01763125) combined constitute the entity Tumorbank.~   "
96862|NCT01789216|"~     The purpose of this study is to definitively resolve questions regarding the use of~     multimodal pharmacologic pain management for orthopedic trauma patients in the context of a~     multicenter, randomized clinical trial.~      Also, as a significant proportion of this population develops chronic post traumatic~     osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and~     incidence of chronic pain and PTOA in this population.~   "
96863|NCT01789203|"~     BK infection is an important cause of graft dysfunction and graft loss after renal~     transplantation. It has been widely accepted that emergence of BK virus correlates with the~     more potent immunosuppressive agents used to lower acute rejection rates. In contrast to~     other opportunistic infections after transplantation, for which routine prophylactic agents~     are administered, there is no effective agent for the prevention of BK infection. Some data,~     however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against~     BK virus. This has led us to investigate whether routine, short-term ciprofloxacin~     administration post-transplant can lower the incidence of BK infection.~   "
96864|NCT01789190|"~     In diabetes, the honeymoon period is characterized by the presence of a functional reserve~     of β-cells that favours an adequate metabolic control and low insulin needs in order to~     control glycaemia. Therefore, the extension of this period could have evident benefits in~     diabetes management. The investigators aimed to study the influence of regular physical~     activity on the prolongation of the honeymoon period~   "
96865|NCT01789177|"~     We hypothesize that the addition of modified incentive spirometry to standard postoperative~     chest physiotherapy will be associated with faster return to baseline/predicted pulmonary~     function and fewer postoperative pulmonary complications in patients following laparotomy.~   "
96867|NCT01789151|"~     Preliminary data following a pilot study from our institution confirms the ability of~     99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent~     disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose~     to extend these findings and further evaluate this imaging modality for its clinical~     utility, limitations, and application.~      An unacceptably high level of morbidity exists amongst patients suffering from rheumatic~     disease. This is often the result of mild disease being missed or misdiagnosed, and therapy~     inordinately delayed or inappropriate. The currently used therapeutic agents themselves have~     associated side-effects adding to unfavourable clinical outcomes. There is therefore a need~     for a superior, less expensive and more easily accessible imaging modality to assess the~     degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a~     manner not too dissimilar to that of glucose, and it can be readily labelled to form~     99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this~     agent, accurately depicting sites of active inflammation/disease.~      HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues~     because of the greater metabolic needs of the cells during active disease. Glucosamine,~     being an analogue of glucose, is metabolised more quickly in inflamed than non-inflamed~     tissue and thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy~     allows for detection of active inflammation. Unlike current bone scans this agent has the~     sensitivity to detect subclinical inflammatory disease that would in turn provide essential~     information to ensure accurate diagnosis and treatment.~   "
96868|NCT01789138|"~     The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the~     impact of a situated treatment adherence intervention program among persons living with~     HIV/AIDS on antiretroviral therapy in Estonia.~   "
96869|NCT01789125|"~     The primary aim of this research study is to enhance smoking cessation outcome among smokers~     with anxiety disorders. We are comparing two group treatment approaches: (1) An~     educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An~     integrated smoking cessation and anxiety treatment program (START). Both treatments also~     utilize nicotine replacement therapy.~   "
96870|NCT01789112|"~     Electric stimulation by cardial contractility modulation (CCM)to improve contractility and~     physical capacity~   "
96871|NCT01789099|"~     In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic~     peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as~     immunological response will be assessed. The purpose of this study is to select a biological~     dose of peptides for further clinical trials. Study recruitment completed at 6 patients in~     every dose level.~      The main study treatment phase of this study is completed and will be reported separately.~   "
96872|NCT01789086|"~     This trial is conducted in Europe. The purpose of the trial is to assess safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of~     liraglutide in obese adolescent subjects aged 12 to 17 years.~   "
96873|NCT01789073|"~     The purpose of this study is to investigate the effect of preoperative immunonutrition on~     complications and length of hospital stay in patients with pancreatic cancer undergoing~     elective surgery.~   "
96874|NCT01789060|"~     PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway.~     However, clinical information about the significance of p-AKT expression in malignant~     lymphoma is not fully understood yet. In this study, we investigated the overexpression of~     p-AKT and its prognostic implication in malignant lymphoma.~   "
96875|NCT01789047|"~     The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed~     comparison between add-on topiramate and add-on placebo to stable treatment with amatadine~     in the treatment of PD patients who continue to have dyskinesia on amantadine.~   "
96876|NCT01789034|"~     A prospective observational study on predictors available and on variables of difficult~     intubation adopting Gliscope video laryngoscope routinely.~      Primary hypothesis of the current study is that the rate of difficult intubation with~     Glidescope is low and multiple predictors interact favorably in anticipating difficulties.~   "
96877|NCT01789021|"~     In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring~     system and blood glucose monitoring systems from other companies across the overall tested~     glucose range will be performed.~   "
96878|NCT01789008|"~     Alcoholic liver disease is the most frequent complication of excessive alcohol consumption.~     Early diagnosis of alcoholic liver disease is essential to avoid its complications that~     could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver~     biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis.~     This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis.~     Because it is non-invasive, fast, given immediate results; transient elastography could be~     repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the~     investigators propose to realize liver biopsy and transient elastography in 300 alcoholic~     patients in weaning to evaluate the transient elastography accuracy in the exclusion of~     sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be~     the liver biopsy.~   "
96879|NCT01788995|"~     This non-interventional study will evaluate the routine use and the safety and efficacy of~     Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer~     (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly~     diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination~     with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.~   "
96891|NCT01788839|"~     The purpose of this study is to see how cancer treatment affects sexual and reproductive~     function. The patient will also be asked to participate in blood draws to see if and how~     cancer treatment affects the ovaries and the ability to have children (fertility). These~     blood draws are optional and the patient can still participate in the questionnaire portion~     of the study even if they choose not to have their blood drawn.~   "
96980|NCT01787630|"~     The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If~     the rectum could be completely moved out of the treated volume, a substantial decrease of~     rectal toxicity seems reasonable. In this study we will develop and evaluate a new~     transrectal injection technique where hyaluronic acid (HA) is injected in the space between~     the prostate and the rectum prior to external beam radiotherapy to increase the physical~     distance between prostate and rectum.~   "
96880|NCT01788982|"~     For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis~     pathway has several potential targets. The Receptors for Vascular endothelial growth factor~     (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the~     formation as well as the maintenance of tumor vasculature.~      In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the~     fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often~     overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in~     tumor angiogenesis express these receptors as well.~      Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive~     results. However there is no treatment that is generally considered as standard of care for~     patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have~     progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a~     clinically meaningful benefit yet.~      Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and~     PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth~     muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this~     multi-kinase activity rationale exists to investigate the effect in MTC and DTC.~      Because it targets these three major angiogenesis signaling pathways it might prevent~     further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active~     in patients who have progressed on agents that target only one pathway.~   "
96881|NCT01788969|"~     The manifestation of weakness and involuntary reflexes following motor incomplete spinal~     cord injury (SCI) may be partly a result of damage to descending pathways to the spinal cord~     that release serotonin. In models of SCI, for example, application of agents that simulate~     serotonin has been shown to modulate voluntary motor behaviors, including augmentation of~     walking recovery. In humans following neurological injury, the effects of 5HT agents are~     unclear. Few previous reports indicate improved motor function following administration of~     agents which enhance the available serotonin in the brain, although some data suggests that~     decreased serotonin may be beneficial. In this application, the investigators propose to~     study the effects of clinically used agents that increase or decrease intrinsic serotonin~     activity in the brain on strength and walking ability following human motor incomplete SCI.~     Using detailed electrophysiological recordings, and biomechanical and behavioral measures,~     the investigators will determine the effects of acute or chronic doses of these drugs on~     voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty~     of this proposed research is the expectation that agents that enhance serotonin activity may~     increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery.~     Despite potential improvements in voluntary function, the use of pharmacological agents that~     may enhance spastic motor behaviors following SCI is in marked contrast to the way in which~     drugs are typically used in the clinical setting.~   "
96882|NCT01788956|"~     The intent of this study is to validate the venous blood oxygenation measurements of the~     Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an~     inserted central vein catheter, which is currently the standard of care for measuring SvO2~   "
96883|NCT01788943|"~     The investigators propose to use positron emission tomography (PET) imaging to determine~     whether nicotinic receptor availability at pretreatment predicts smoking cessation success.~     The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of~     Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic~     receptor availability using the PET radioligand 2-[18F]FA, after overnight abstinence and~     prior to initiation of treatment.~   "
96884|NCT01788930|"~     Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet~     activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence~     up to 60%.~      The main objective of our study is to analyze the influence of sleep apnea on the response~     to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.~      Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep~     apnea will be recruited after providing informed consent. Response to aspirin will be~     assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal~     polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other~     endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at~     baseline to determine their influence on the response to aspirin.~      Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h) and response with Aspirin~     (ARU > 454) will be randomized to 3 months of active or sham continuous positive airway~     pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin~     will be compared between the sham and effective CPAP groups.~   "
96885|NCT01788917|"~     The study was performed to investigate the effects of a daily consumption of linseed oil on~     fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.~   "
96886|NCT01788904|"~     In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma~     fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI)~     undergoing primary percutaneous angiographic intervention.~      The investigators postulate that patients with fully re-established intestinal blood flow~     and vital intestines will display a significant drop of plasmatic i-FABP within 24 hours,~     while patients requiring subsequent intestinal resection due to irreversible bowel necrosis~     will not.~      If true, patients requiring laparotomy and bowel resection could be identified and patients~     in whom angiographic intervention led to successful cure of disease would not be exposed to~     potentially perilous surgery.~   "
96887|NCT01788891|"~     This study will help identify which ARV candidates should be prioritized for pediatric use~     in resource-limited settings~   "
96888|NCT01788878|"~     The aim of this study is to explore the main factors associated with the return to work of~     patients presenting an upper aero-digestive tract cancer.~   "
96889|NCT01788865|"~     The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable~     dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.~   "
96890|NCT01788852|"~     This study will assess the prevalence of HPV infection in perinatally HIV-infected~     adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.~   "
96981|NCT01787617|"~     The purpose of this study is to investigate the effect of an exercise training intervention~     on the ability of African American males to use insulin properly. Insulin is a hormone that~     helps the body use glucose.~   "
96892|NCT01788826|"~     The incidence of ventral hernias has remained inappropriately high. Any innovation in order~     to reduce this incidence would be simply cost-effective. Although there is still some~     concern about the use of mesh in clean-contaminated or contaminated surgery, based in our~     experimental studies, we plan to use a mesh in the primary closure of abdominal incision to~     prevent incisional hernias.~      The investigators propose a clinical trial to assess a model to prevent the incisional~     hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization~     is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide~     polypropylene mesh is fixed covering the midline closure; in the control group a~     conventional closure with a running suture of long-term absorbable material with a~     suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of~     ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and~     a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of~     follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are~     adult patients with a previous ventral hernia, estimated survival of less than 6 months or~     hemodynamic instability during surgery.~      The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24~     months and abdominal CT controls at 6,12, and 24 months. The study will be statistically~     evaluated with SPSS 18.0.~   "
96893|NCT01788813|"~     The purpose of this study is to examine the safety and effects on the immune system of~     treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to~     pollen or perennial allergen, with or without mild asthma. In addition, the effect of~     treatment with GSK2245035 on the body's allergic response in test situations will be~     explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each~     receiving 80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng~     GSK2245035) and 14 subjects will receive the dummy drug (placebo) during the study.~     Assignment of a subject to GSK2245035 or placebo will be done by chance, like flipping a~     coin. Neither the subjects nor the clinic staff will know whether a subject is being dosed~     with GSK2245035 or placebo during the course of the study. The study will include (a)~     Screening phase where the eligibility of subjects for enrolment will be assessed (b)~     Treatment phase during which subjects will receive either 8 nasal sprays of GSK2245035 80 ng~     or a matching placebo once weekly for 8 weeks (each dose will be split between the two~     nostrils). Subjects participating in this study in 2014 will receive a reduced dose of 20 ng~     i.n. of GSK2245035 once weekly for eight administrations (c) Follow-up period where any~     GSK2245035 induced changes to the immune system and the effect of treatment on the body's~     allergic response in test situations will be monitored. The maximum planned study duration~     for all subjects, including the screening, treatment and follow-up periods, is approximately~     180 days.~   "
96894|NCT01788800|"~     Physical activity (treadmill) supports the effect of cognitive behavioural therapy in~     patients with panic disorder with/without agoraphobia~   "
96895|NCT01788787|"~     The goal of this behavioral research study is to learn about the outcomes of smoking~     cessation treatment. Researchers want to learn how many smokers stopped smoking after taking~     part in smoking cessation treatment with the Texas Quitline.~   "
96896|NCT01788774|"~     This clinical trial is designed to evaluate different dosages of risperidone ISM, a new~     long-acting injectable form.~   "
96897|NCT01788761|"~     This is a research study that will look at the effects of giving two nutritional supplements~     on extremely low birth infants (infants weighing less than 1000 grams or weighing less than~     approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied~     are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that~     each contain a different probiotic. In this study the investigators will mainly be looking~     at the effect that these supplements may have on how well babies tolerate their feedings and~     how long they require supplemental intravenous fluids for nutritional support. The~     investigators will also, however, look at many other factors such as rate of growth, rates~     of infection, survival rate and the length of time the infant needs to be in the hospital.~     The investigators will also look at its effect on conditions/complications of prematurity~     such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung~     associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious~     diseases of the infant's intestines), retinopathy of prematurity (eye disease associated~     with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus~     arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that~     does not close spontaneously (by itself).~   "
96898|NCT01788748|"~     This is an interventional open prospective randomized study, done in two sites.~      The main purpose of this study is to evaluate the efficacy of the combination of bipolar~     radiofrequency potentiated by an infrared light followed by fractional bipolar~     radiofrequency for the treatment of striae on the abdomen.~      In order to have a more complete and accurate study, each technology will also be evaluated~     separately. This will allow the comparison of the effect of each treatment, in monotherapy~     or combined.~   "
96907|NCT01788631|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works~     in treating a specific disease, in this case Sickle Cell Disease (SCD). Investigational~     means that the drug is being studied. It also means that the FDA has not yet approved the~     drug for your type of disease.~      SCD is an inherited blood disorder that causes the red blood cells to change their shape~     from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a~     different type of protein that carries oxygen in their blood (hemoglobin) than people~     without SCD. This different type of hemoglobin makes the red blood cells change into~     crescent shape under certain conditions. Sickle-shaped cells are a problem because they~     often get stuck in the blood vessels blocking the flow of blood, and cause inflammation and~     injury to important areas in the body.~      Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury~     caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast~     infusion during a heart stress test in people who are unable to exercise enough to put~     stress on their heart by making the heart beat faster. Regadenoson has been studied as a~     long infusion at this dose in adults, and no safety issues have been identified~     (ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient~     benefit with the long infusion of the drug. This drug has been used in laboratory~     experiments and information from those other research studies suggests that this drug may~     help to protect the body from damage caused by sickle-shaped cells in this research study.~      In this research study, the investigators are specifically looking to see if Regadenoson is~     an effective treatment for pain crises and acute chest syndrome in SCD.~   "
96908|NCT01788618|"~     Our study aims to measure the impact of cognitive rehabilitation workshops on the~     development of cognitive functions and quality of life of patients expressing a cognitive~     complaint~   "
96899|NCT01788735|"~     Unexplained infertility is defined as the lack of thec ability to become pregnant during the~     first year, although the periods of the woman, the semen from the man and the laparoscopic~     findings are normal. In Denmark do roughly every fifth to seven couple in the fertile age~     have problems becoming pregnant for a various kind of reasons, of these are 10-15 %~     unexplained infertile.~      Many factors are pointed out as imported. In particularly lifestyle factors such as the~     diet, smocking, obesity, lack of physic activity and alcohol. The causal connection is yet~     to be found, but it is assumed that there is a link between infertility and endocrine,~     neurological and immunological factors.~      Asthma and allergy are some of the most common diseases among young people in western world~     .The development of these diseases are caused by both hereditary factors, and factors that~     also seem to be important in infertility.~      It is clinically observed that many unexplained infertile patients simultaneously suffer~     from asthma and allergy. Furthermore this group of patients seems harder to treat in terms~     of becoming pregnant during fertility treatment then healthy not asthmatic and non allergic~     persons.~      There is limited available data about this subject and the data that is already collected~     does not show a clear tendency.~      Hypothesis: Atopic asthma is characterized by a systemic inflammation and can therefore be~     the reason for infertility among this group of patients.~      The aim:~      The aim of this study is to examine whether female asthmatics and allergic are less fertile~     then healthy females- whether there is there a link between asthma and infertility.~     Furthermore if an optimal asthma treatment during fertility treatment reduces time to~     pregnancy.~   "
96900|NCT01788722|"~     The objective of the study is to investigate and collect post marketing data on the safety~     and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a~     subset of patients - at optional long-term follow-up visit after about 1 year of treatment~     under daily practice treatment conditions in Korean women and to obtain data on drug~     utilization on treatment for endometriosis.~   "
96901|NCT01788709|"~     The colonoscopy accuracy and safety depend on the quality of colon cleansing. An~     inadequately prepped bowel will increase the risk of missing a lesion, prolong procedure,~     increase patient discomfort, and eventually increase complication rate. Therefore an~     excellent colon cleansing is of extreme importance to the endoscopist and the patient.~      Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability~     and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte~     (MoviPrep®) in bowel cleansing for colonoscopy.~   "
96902|NCT01788696|"~     The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic~     tool in the management of early Parkinson's disease (PD).~   "
96903|NCT01788683|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted~     supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy~     and durability up to 24 months.~      Secondary objectives include evaluation of US evidence of tendon repair; incidence of~     post-operative complications, adverse events, re-injections, and surgical intervention;~     change in pain score and use of pain medications.~   "
96904|NCT01788670|"~     Health benefits for humans derived from low dose intake of ethanol could partially be~     explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to~     induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol).~     Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The~     study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.~   "
96905|NCT01788657|"~     Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in~     several studies, however the investigators know very little about how the written treatment~     material should be designed to be effective and at the same time acceptable to the patients.~     The investigators are not aware of any research that has investigated if slow readers, or~     persons with difficulty concentrating, can use the standard material or if they would~     benefit more from using an adapted version.~      In this study the investigators will assess reading speed and the ability to concentrate in~     all patients and then randomise them to an internet-based treatment for depression using~     either a standard material or a condensed one. The condensed material consists of 30000~     words and will be available as text files and on audio files. The standard material consists~     of 60000 words and is only available as text files. Both groups will have the possibility of~     e-mail contact with a personal therapist during the treatment.~      Patients will be recruited within Örebro County by referrals and self-referrals. The goal is~     to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks~     and all patients will be assessed for depression at an interview with a psychologist. There~     will also be interviews after treatment and one year after treatment. The most important~     outcome will be depressive symptoms.~   "
96906|NCT01788644|"~     The purpose of this study is to examine risk factors associated with infant growth and the~     development of obesity in the first year of life. The investigators plan to establish a~     racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed~     regularly from birth to 12 months of age. The cohort will be residents of Durham, North~     Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will~     examine factors contributing to the development of obesity, including dietary behaviors,~     physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home~     assessments throughout infancy and contact with other care providers will help pinpoint~     exactly when children begin to gain weight excessively and will identify risk factors~     related to energy intake, energy expenditure, stress, and sleep associated with obesity.~   "
96909|NCT01788605|"~     1. The purpose of this study is to determine the efficacy of ramosetron for the prevention~          of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic~          treatment during hematopoietic stem cell transplantation~        2. The study hypothesis is that ramosetron is effective for the prevention of emesis and~          control of emesis and/or vomiting that develop after the prophylactic antiemetic~          therapy in the setting of hematopoietic stem cell transplantation~   "
96910|NCT01788592|"~     The objective of this study is to evaluate effectiveness and safety of drug-eluting stent~     implantation in the real world daily practice.~   "
96982|NCT01787604|"~     Authors hypothesize that aortic root reimplantation procedure is superior over standard~     aortic valve reimplantation procedure in the incidence of aortic valve replacement.~   "
96911|NCT01788579|"~     This study aims to conduct a randomized controlled trial that will test the feasibility and~     preliminary effect of a multimedia version of a computerized multimedia intimate partner~     violence (IPV) prevention service tool designed to increase identification of IPV~     victimization and to improve linkages to IPV-related services among female offenders under~     court supervision or probation, compared to a non-media version of the same IPV screening,~     brief intervention and referral service delivered by a case manager. The study addresses the~     following: Primary study aims~        1. To design and beta-test a Computerized Multimedia IPV Screening, Brief Intervention and~          Referral Service tool for female offenders under court supervision or probation.~        2. To obtain preliminary estimates of the effects of the Computerized Multimedia versus~          the Case Manager IPV service conditions on identification of different types of IPV~          during the service session and on access to and utilization of IPV services over the~          three-month follow-up period.~        3. To examine and enhance the feasibility (recruitment, enrollment, fidelity of service~          delivery, client satisfaction, safety, and retention) for a future larger scale R01~          study.~           Secondary study aim~        4. To obtain estimates of the effects of the Computerized Multimedia versus the Case~          Manager IPV service conditions on recidivism, adherence to drug treatment (e.g.,~          attendance, completion) and abstinence of substance use over the follow-up period,~          controlling for baseline outcomes.~   "
96912|NCT01788566|"~     The purpose of this study is to see how participants with late stage lung cancer do on~     gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the~     drugs are in combination and to see how long the medicine stays in the body. The study will~     last approximately 2 years.~   "
96913|NCT01788553|"~     The aim of the study is to assess the remission rates in patients treated for generalized~     anxiety disorder in primary and specialized care. Factors that may influence remission such~     as disease history and severity of the anxiety disorder, the type of treatment, the presence~     of co-morbid depression or anxiety disorder as well as socio-demographic factors will also~     be evaluated. The study will also assess patient functioning and compare functioning in~     patients who do and do not achieve remission.~   "
96914|NCT01788540|"~     Intralipid infusion can improve the outcome in NK cells positive females with history of~     recurrent miscarriages undergoing IVF/ICSI cycles.~   "
96915|NCT01788527|"~     The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose~     Monitoring) can improve glycemic control in women with T1D who are pregnant or planning~     pregnancy without substantially increasing the rate of hypoglycemia.~   "
96916|NCT01788514|"~     The investigators have developed an influenza-vaccination-education-study-program that will~     involve the use of an animated influenza vaccine-based computer program (videogame) that is~     designed from the investigator's own initiative. The investigators propose implementing an~     influenza vaccination educational program in the pediatric satellite office that serves a~     population that has historical low rates of influenza vaccination.~   "
96917|NCT01788501|"~     This study aims to compare efficacy and safety of tacrolimus/methotrexate with~     cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic~     hematopoietic stem cell transplantation patients.~   "
96918|NCT01788488|"~     The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on~     duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia~     at Mayo Clinic Health System Eau Claire.~   "
96919|NCT01788475|"~     Currently medications injected intravitreally in previously vitrectomized eyes have a very~     short half-life due to enhanced clearance of the drug. The use of the Ozurdex implant may~     allow sustained levels of steroid delivery to patients with diabetic macular edema that have~     undergone prior vitrectomy. The sustained steroid levels may lead to improved central~     retinal thickness measurements and improved visual acuity.~   "
96920|NCT01788462|"~     Sleep-disordered breathing is characterized primarily by partial or total upper airway~     obstruction during sleep. The most common form of sleep-disordered breathing is obstructive~     sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep~     state. The major risk factors associated with the development of sleep apnea are obesity and~     male sex. The investigators have also found a high prevalence of OSA in HIV infected men and~     women, particularly among those with central lipohypertrophy, which is a common finding in~     HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is~     that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy,~     alters both mechanical properties and compensatory neuromuscular responses leading to upper~     airway obstruction. Based on our most recent findings in the non-HIV population, the~     investigators demonstrate that obesity is associated with elevations in the upper airway~     load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses.~     Moreover, the investigators have found that female sex, peripheral adiposity, and younger~     age are associated with increased compensatory neuromuscular responses, while male sex,~     central adiposity, and older age are associated with blunted compensatory responses. The~     loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among~     HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone~     releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue.~     The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and~     neurocompensatory alterations associated with increased central obesity. In this project the~     investigators will determine whether tesamorelin affects sleep apnea severity and~     compensatory neuromuscular responses of the upper airway on sleep and breathing in men and~     women with HIV infection. The proposed studies are designed to elucidate the~     pathophysiologic basis for the development of obstructive sleep apnea in this population.~     The studies also provide insights into the neurohumoral regulation of upper airway function,~     and potentially new approaches to the treatment for sleep-disordered breathing.~   "
96921|NCT01788449|"~     Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and~     infection of bacteria.~   "
96922|NCT01788436|"~     The purpose of this study is to measure and contrast implicit and explicit learning~     performance in patients with schizophrenia relative to young and elderly healthy volunteers.~   "
96923|NCT01788423|"~     The purpose of this study is to compare the outcomes for two different hearing-aid delivery~     models. In one model, the audiologist selects and fits the hearing aid and, in the other~     model, the consumer does this directly.~   "
96924|NCT01788410|"~     The objective of this study is to provide pain relief to patients with facet joint disease~     or head and neck pain related to compression of a nerve root. The goal is to provide~     palliative care with superior efficacy and longer relief compared to current methods.~   "
96925|NCT01788397|"~     The main hypothesis:~      The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The~     groups waiting for rehabilitation is compared with the group receiving rehabilitation~   "
96926|NCT01788384|"~     Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant~     Pharmaceuticals, North America, is a safe and effective topical therapy used for the~     treatment of acne vulgaris.~   "
96928|NCT01788358|"~     This study examines the long term safety and efficacy of the Fixed Dose combination~     BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in~     patients with moderate to severe hypertension.~      Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks,~     including 8 weeks with stepwise dose increase up to the high target dose. The first 200~     subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in~     total).~      Subjects who do not tolerate an increased dose will be treated at their highest tolerable~     dose.~   "
96929|NCT01788345|"~     The purpose of this study is to determine whether the new Boussignac-system of non-invasive~     ventilation is as good as the conventional non-invasive System in patients presenting with~     acute hypercapnic respiratory failure.~   "
96930|NCT01788332|"~     In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority~     from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients~     with NSCLC but those treated will still only live for an average of 9 or 10 months after~     diagnosis.~      The purpose of this clinical trial is to find out whether or not giving a drug called~     Olaparib following chemotherapy will benefit patients with NSCLC who have responded to~     initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is~     a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The~     rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC~     tumours that respond to chemotherapy are less able to repair this damage. This can be~     exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase~     (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell~     death by a mechanism known as synthetic lethality. Synthetic lethality arises when a~     combination of mutation in two or more genes leads to cell death.~      Up to 300 patients who are to receive standard chemotherapy treatment will be initially~     registered into the trial. Of these patients, 114 patients who have responded to~     chemotherapy will be randomly allocated to receive either Olaparib or an inactive dummy pill~     or placebo by mouth. The trial will assess whether Olaparib delays disease progression~     following standard chemotherapy treatment in patients. It will also show whether the side~     effects of adding Olaparib following standard treatment are acceptable.~   "
96931|NCT01788319|"~     This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as~     or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment~     strategy for glaucoma patients. It is done with a laser device that can also be used for~     many other ophthalmic applications, thus reducing the economic burden of treatment.~   "
96932|NCT01788306|"~     This prospective, randomized emergency department trial will study the effectiveness of an~     intervention that combines opioid overdose prevention, education and intervention that~     includes take home naloxone with brief behavioral change counseling. The study will recruit~     both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose~     (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk~     behaviors.~      Primary Aims~      The primary aims are to test whether those who receive the intervention compared to standard~     care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use,~     inappropriate medication use, and other overdose risk behaviors.~      Secondary Aims~      The secondary aims are to test whether those who receive the intervention compared to~     standard care have: 3) More appropriate health care utilization (e.g. fewer emergency~     department visits and admissions to inpatient care); 4) Lower total health care costs; 5)~     Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users~     at risk for overdose and whether the intervention impacts these behaviors.~   "
96933|NCT01788293|"~     Oximetry monitoring is common practice in patients undergoing anesthesia. PVI continuous~     evaluation may be a possibility of agility and ease of obtaining accurate information about~     the state of cardiovascular responsiveness to volume expansion.~      This prospective and randomized study will try to demonstrate that the assessment of PVI is~     a simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring~     technologies. Such a simple approach has therefore the potential for widespread application~     as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery~     monitoring technologies in many institutions, as well as in many countries.~   "
96934|NCT01788280|"~     This exploratory study uses [18F] Fluciclatide and Positron emission tomography (PET)~     imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The~     primary objective of this study is to determine the association of [18F] Fluciclatide~     uptake, fludeoxyglucose (FDG) uptake, and tumor blood flow/perfusion determined with H215O~     and Magnetic resonance imaging (MRI) and correlate these variables with time to progression~     (TTP) in participants with GBM treated with Bevacizumab.~   "
96935|NCT01788267|"~     Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD)~     potentially leading to pathological fractures at adult age. Recent data from our center and~     others have suggested that low BMD could be observed very early in life. However,~     quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be~     confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).~      High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology~     with very high spatial resolution. Images obtained with this technic are considered as~     virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces~     exploration in a three-dimensional manner, and therefore provides informations on bone~     microarchitecture as well as bone density.~      The aim of this study is to evaluate bone microarchitecture of paediatric patients matched~     to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be~     collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore~     potential correlations HR-pQCT parameters.~   "
96948|NCT01788098|"~     The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that~     purpose samples of DNA will be collected from 500 RA patients and similar number of controls~     from whole Slovakia. Variations in several genes associated with RA will be evaluated. The~     second aim is to assess functional changes in immune cells from selected patients and their~     evaluation together with genetic background. The project has observational character without~     any intention to change the treatment of RA patients.~   "
96936|NCT01788254|"~     Aim of this study is to comprehensively assess in healthy volunteers the metabolic processes~     and factors that define drug response. Sources of variability are to be investigated and~     factors that can alter the hepatic metabolism and the pharmacokinetics of drugs shall be~     quantified.~      Determination of variability is important when the pharmacokinetics of new drugs is being~     investigated and when the concept of individualized medicine is to be further developed. It~     is important to identify and differentiate between pharmaceutical, physiological (e.g. liver~     blood flow, renal function), environmental (e.g. foods and lifestyle), and genetic sources~     of inter-individual variability. For instance, inaccurate or false conclusions may be drawn~     from a single pharmacokinetic study, if the investigated medicine is metabolized by an~     enzyme with large inter-individual variability. Knowing the causes of variability and of the~     quantitative contribution of various processes might help to improve the oral formulations~     of drugs, might help selecting the right preclinical tests and selection criteria during~     clinical development, provide the basis to understand the influence of disease and to~     optimize established drug treatments in order to make future drug treatment safer and more~     efficient.~      This study is designed as an add-on to the study TWINS: Open Label Repeated Dose Study for~     the Evaluation of Heritability of and Genetic Influences on Drug Pharmacokinetics~     (Eudra-CT: 2008-006223-31). Twins are not a random sample of the population, and they differ~     in their developmental environment. In this sense they are not representative for the~     population Thus, the results of TWINS cannot be automatically generalized but instead~     require validation in a representative population sample. While both studies assess~     pharmacologic factors important for drug response, TWINS contributes in particular data on~     the heritability of these processes.~   "
96937|NCT01788241|"~     Psychosocial factors have been found to be associated with an increased risk for coronary~     artery disease incidence, progression and worse clinical outcomes.~      Patients with non-significant coronary artery disease (confirmed vascular irregularities,~     but <60% coronary occlusion) often present with complaints such as chest pain, which warrant~     screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of~     this group of patients with mild stenosis remains to be investigated in more detail, and we~     propose that psychosocial factors play a role in the clinical prognosis and patient reported~     outcomes in this group.~      A special focus lies within examining personality characteristics, of which Type D~     personality is a primary predictor variable for prognosis. Type D personality is~     characterised by high negative affect and high social inhibition. In addition to~     psychosocial factors (personality, mood state, social support, SES),~     biomarkers(inflammation, clotting, DNA) as well as standard clinical risk factors (metabolic~     syndrome, activity level, smoking, medication use, disease severity) will be investigated.~      The goal of the proposed study is to investigate a preexisting psycho-biochemical risk~     profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a~     group with angiographically or CT-scan confirmed, non-significant coronary artery disease.~   "
96938|NCT01788228|"~     The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals'~     vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk~     of exposure to the virus.~   "
96939|NCT01788215|"~     The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline,~     on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian~     Syndrome (PCOS).~   "
96940|NCT01788202|"~     When it is safe to administer general anesthesia to the patient with cocaine positive urine~     drug screen has never been clearly determined. The study doctors would like to determine the~     effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery,~     the subjects will be observed in regards to mental status and any changes in heart rate and~     rhythm.~   "
96941|NCT01788189|"~     Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed~     or refractory CD20-positive aggressive lymphomas~      Phase I:~      Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a~     3 + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6~     cycles~      Phase II:~      Treatment of 20 patients at maximum tolerated doses of phase I~   "
96942|NCT01788176|"~     To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of~     zoledronic acid in managing pain in Complex Regional Pain Syndrome patients.~   "
96943|NCT01788163|"~     Interventional diagnostic, international, multicenter and non-comparative study of EGFR~     mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with~     adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and~     Russia and will assess the current status of EGFR mutation testing, and the concordance of~     EGFR mutation status derived from tumour samples and blood based circulating free DNA.~   "
96944|NCT01788150|"~     A prospective, randomized, active-control, multi-center clinical trial comparing the safety~     and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to~     that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.~      The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary~     Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting~     Stent in patients with single, never previously treated coronary artery lesions~   "
96945|NCT01788137|"~     This is a prospective , open, multicenter, randomized phase III study. The investigators~     planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT~     regimen groups after signature the informed consents. The patients will receive safety~     assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up~     will be received after finishing the treatment.~   "
96946|NCT01788124|"~     The purpose of this study is to evaluate the comfort of two type of speculums used during~     routine gynecologic exam. Your treatment and medical care will not change because you are~     participating in this study. Your doctor will continue to make all decisions regarding your~     proper treatment and care.~   "
96947|NCT01788111|"~     The purpose of this project is to investigate the occurrence of neck and back pain in a~     population of commercial helicopter pilots, and investigate factors related to the~     profession that can cause these problems. The project has a biological approach assessing~     the supporting and stabilizing muscles (multifidus) in pilots with chronic back and neck~     ailments. Pilots with low back problems are invited to a controlled intervention trial to~     investigate whether one can achieve improved spinal health with a rigid training régime.~     Primary trial outcome is improved neck and back multifidus muscles pathology and function as~     assessed by the extent of fat infiltration -as visualized on MRI - and the volume and~     ability of the lumbar multifidus muscles to contract as shown with ultrasound. The perceived~     effect on spinal health with sick leave frequency is also evaluated.~   "
96997|NCT01787409|"~     This partially randomized clinical trial studies cholecalciferol in improving survival in~     patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may~     improve tumor response and survival and delay time to treatment in patients with cancer who~     are vitamin D insufficient.~   "
96949|NCT01788085|"~     Study Hypothesis: This study is designed as an integral part of the development of new or~     improved features or components of the Bravo® pH Monitoring System and may serve~     verification and validation purposes.~      The study population will include symptomatic patients with known or suspected~     gastroesophageal reflux disease~      Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery,~     positioning and attachment. Confirmation of capsule attachment may be done endoscopically.~      These procedures will serve to evaluate overall system performance in actual clinical setup,~     for instance: ergonomics and performance of delivery device, capsule transmission etc.~      Physician may be asked to provide feedback on the procedure and/or document their activities~     during the procedure.~   "
96950|NCT01788072|"~     There is substantial evidence from animal model and healthy control data, that oxytocin is~     involved in the modulation of social cognition. In addition, recent genetics and plasma~     level studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum~     Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and~     will likely require treatment, the lack of data to make meaningful treatment recommendations~     to facilitate adult living is an urgent issue. This study will examine the effect of~     intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that~     IN-OXT will be superior to placebo in improving social function by the end of study~     treatment.~   "
96951|NCT01788059|"~     Because the rate of non union of long bone in lower extremities specially in tibia in this~     two last decade due to malnutrition and smoking and other risk factors was increased, so~     many patient in our country suffer from non union on the other hand it seems that the use of~     the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide~     to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with~     ficoll procedure to non union site in patient that are resistant to other treatment. Then~     the investigators will follow the patient with monthly radiography and evaluate the callus~     volume and clinical union and any side effect of this treatment.clinical union consider to~     relief pain in non union site and be stable in examination.~   "
96952|NCT01788046|"~     This study is designed to assess the efficacy and safety of AMG 416 compared with placebo in~     the treatment of SHPT in CKD subjects receiving hemodialysis as assessed by the change from~     baseline in serum iPTH, cCa x P and phosphorus.~   "
96953|NCT01788033|"~     To assess the effects of treatment with XOMA 052 on beta-cell function and insulin~     production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and~     pharmacokinetics (PK) of XOMA 052 will also be assessed.~   "
96954|NCT01788020|"~     In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates~     and responses of short duration compared to other indolent lymphomas. Thus innovative~     approaches are needed which combine excellent activity and tolerability in patients with WM,~     who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab,~     cyclophosphamide) was shown to be highly effective in patients with WM without inducing~     major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed~     substantial activity as a single agent in WM with only very few side effects when given in a~     weekly schedule. Based on these observations it is the aim of this study to test whether the~     efficacy of the well tolerated DRC regime can further improved by adding Bortezomib.~   "
96955|NCT01788007|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod)~     3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference~     formulations will also be compared to a placebo cream to test for superiority.~   "
96956|NCT01787994|"~     This is an open label, dual cohort study evaluating safety, tolerability and immunogenicity~     of redirected CD4+ T cells in HIV subjects.~   "
96957|NCT01787968|"~     T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII,~     including all non-TcI). TcI is predominant in Mexico and Central America, while TcII~     (non-TcI) is predominant in most of South America, including Argentina. In recent studies~     from Argentina, the risk of congenital transmission has been estimated to vary between 2.6~     percent and 7.9 percent. By contrast, we know very little about the congenital transmission~     of TcI. It has been suggested that congenital transmission of T. cruzi is strain related,~     and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our~     primary hypothesis is that congenital transmission rates are different for TcI versus TcII.~     Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g.,~     age, parity, transmission in previous pregnancies) and their exposure to vectors are~     different in regions where TcI is predominant versus regions where TcII (non-TcI) is~     predominant. To test these hypotheses, we propose to conduct a prospective study to enroll~     at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina.~     We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results~     are positive, we will identify infants who are congenitally infected by performing~     parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10~     months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi~     genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of~     congenitally infected newborns, and serological examinations on siblings. We will estimate~     the exposure to vectors in the household. In addition, we will measure prenatal outcomes~     among infected and uninfected infants with seropositive mothers, and the birth weight of~     their siblings. The specific aims of this study are: 1) To determine the rate of congenital~     transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers'~     characteristics and exposure to vectors in regions where TcI is predominant and regions~     where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and~     uninfected infants born to TcI and TcII seropositive women.~   "
96958|NCT01787955|"~     Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative~     treatment modality for periampullary tumor. High mortality rates after PPPD have been~     reduced down to 1%. However, postoperative morbidities are still reported around 10 to 20 %~     even in high volume centers.The delayed gastric emptying syndrome(DGE) is one of major~     complications after PPPD. Many randomized control studies reported that pylorus preserving~     method was not related to the occurence of DGE. Thus,we assumed that large amount of biliary~     and pancreatic juice might affect DGE.~      With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the~     investigators started the recruitment of patients with a periampullary tumors to this~     clinical trial from february 2013 with the study hypothesis that patients with Braun~     anastomosis had less DGE than those who only got conventional PPPD.~      The investigators have calculated the number of patients necessaries to have statistical~     significant differences in 60 patients with a rate DGE expected to be higher than 30%.~      The study include all the patients that usually arrive to our surgery department and who are~     indicated to PPPD for the curative treatment of periampullary tumor.~      The study is randomized, double blind where the investigators and the patients do not know~     if the patients are in the Braun anastomosis group or not, and prospectively analyzed. All~     the clinical and laboratory or radiographic finds relative to the occurrence of DGE are~     recorded.~   "
96959|NCT01787942|"~     Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development~     of dry eye symptoms, and is influenced to a significant degree by the anatomy and function~     of the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic~     reasons, may subtle differences in eyelid anatomy that pre-dispose them to having an~     abnormal tear lipid layer. Moreover, the changes in anatomy and contour of the eyelids~     following blepharoplasty introduce a whole new group of factors, such as an altered~     palpebral aperture and altered canthal fixation that can further change the eyelid's ability~     to maintain a healthy tear lipid layer, for better or for worse. Such changes in tear lipid~     layer can be detected with the aid of a newly acquired tear interferometer (LipiView,~     Tearscience Inc.), but has never been done in the context of blepharoplasty management. Due~     to the strong association between LLT and risk of dry eyes, we hope to investigate if there~     are significant differences in LLT and other objective dry eye parameters in two situations:~     1) patients considering blepharoplasty as compared to other patients not considering such~     procedures 2) patients before and after undergoing blepharoplasty. The results of these~     investigations can go towards establishing LLT as an important objective parameter to~     account for before and after blepharoplasty.~   "
96960|NCT01787929|"~     The purpose of this study was to identify the clinical relevance of cementless~     hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of~     cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the~     relevance of cementless hemiarthroplasties in displaced femoral neck fractures.~      150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented~     hemiarthroplasty. They will be followed during one year after the surgery, with a~     functionality assessment at 3 month and 12 month.~   "
96961|NCT01787916|"~     To our knowledge, no trial has specifically studied the effect of liraglutide combined with~     a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric~     model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of~     abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard~     euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this~     population.~      Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment~     will present improved glucose control with decreased HbA1c, decreased fasting and mean~     weekly glucose concentrations and glycemic excursions as well as increased insulin~     sensitivity compared to participants on placebo/insulin treatment. Participants with~     liraglutide/insulin treatment will also present improved endothelial function, lower body~     weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by~     visual analogue scales.~   "
96962|NCT01787903|"~     The purpose of this study is to determine what the effects are of real-time continuous~     glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus~     and impaired hypoglycemia awareness.~   "
96963|NCT01787877|"~     Stroke represents the third commonest cause of death after heart disease and all types of~     cancer combined, and is the leading cause of long-term permanent disability among adults.~     Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment~     for acute ischemic stroke but only a small fraction of patients are eligible for a~     thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its~     uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many~     patients from potentially beneficial treatment.~      For an appropriate triage and management of patients, it is essential to improve imaging~     techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently~     considered as an investigational technique, permits a quantitative determination of the~     cerebral perfusion within the brain. It helps distinguish salvageable ischemic penumbra from~     irreversibly infarcted core in acute stroke patients. This technique has therefore the~     potential to select patients who are most likely to benefit from thrombolysis with tPA, can~     be used to predict the benefit after thrombolysis and determine the suitability for other~     therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to~     identify possible persistent cerebral ischemia but also provide important information for~     rapid instigation of prophylactic strategies.~      The diagnosis and management of patients with ischemic stroke and TIA is challenging and is~     primarily based on clinical assessment in conjunction with neuroimaging. Development of~     specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude~     common stroke mimics such as migraine or epileptic seizures, identify patients at risk of~     disease, and help guide patient treatment by predicting complications following t-PA~     treatment would be of great value.~   "
96964|NCT01787864|"~     We propose a tissue sample collection study for patients at UNC who have undergone or will~     undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal~     adenocarcinoma as part of routine medical care.~      Purpose:~      To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and~     after ablative therapy.~      To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative~     therapy.~      To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in~     the cardia.~      To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict~     incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53,~     Ki67, cyclin D1, and cyclin A, will be assessed.~   "
96965|NCT01787851|"~     Patients with dilated cardiomyopathy who present for indwelling right heart catheterization~     will be enrolled and randomized to either control or triheptanoin oil for five days.~     Hemodynamics will be assess serially.~   "
96966|NCT01787838|"~     The purpose of this quality improvement project is to improve the immunization rates of an~     at-risk adult population seen in an ambulatory healthcare environment, through the use of~     targeted health education messages regarding pneumococcal immunization. Patients seen in an~     out-patient pre-surgical testing center will receive 1) a one-page written information sheet~     that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this~     message, provided by the clinical staff, during the patient's interview.~      At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory~     healthcare environment (a pre-surgical testing center) will receive a one page,~     gain-framed message that emphasizes the benefits of pneumococcal vaccinations. This~     educational material will be reviewed and reinforced by clinical staff during the assessment~     phase of the clinical visit. Among this group, there will be increased vaccination rate~     compared with at-risk adult patients who did not receive this communication (prospective vs~     retrospective data).~   "
96979|NCT01787643|"~     The purpose of this research study is to determine whether height-adjustable desks change~     sitting and standing time at work and away from work, engery expenditure, dietary intake,~     and body composition. Intermittent peroids of standing made possible by height-adjustable~     desks may help to impart long-term health benefits.~   "
96967|NCT01787812|"~     The California Joint Replacement Registry (CJRR) was created to meet the need for~     comprehensive, scientific assessment of devices, treatment protocols, surgical approaches,~     and patient factors influencing the results of hip and knee replacement surgeries.~     Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical~     information and direct feedback from patients about the outcomes of hip and knee replacement~     surgeries. It is one of only a small number of registries in the United States to do so.~      The CJRR's goals are to:~        -  Collect and report scientifically valid data on the results of hip and knee~          replacements performed in California, including device safety and effectiveness,~          post-operative complication and revision rates, and patient-reported outcomes; and~        -  Promote the use of performance information regarding hip and knee replacements to guide~          physician and patient decisions and to support programs for provider recognition and~          reward.~      Specifically the CJRR is designed to:~        -  Minimize burden on participants by using electronic data sources, rather than manual~          data entry or chart review.~        -  Compile reports assessing the outcomes associated with different devices and surgical~          techniques.~        -  Create benchmarking reports for physicians and hospitals that detail performance data~          and compare it to statewide averages.~        -  Transmit safety alerts on devices with short-term results that provoke concern.~        -  Shape a measurement and reporting system for total hip and total knee replacement~          surgeries.~      The CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business~     Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the~     day-to-day operations of the CJRR.~      CJRR's data elements are aligned with other major orthopedic registries. The CJRR is a~     member of the International Consortium of Orthopedic Registries (ICOR) and the International~     Society of Arthroscopic Registries (ISAR).~   "
96968|NCT01787799|"~     The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound~     (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System~     (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in~     length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by~     visual estimate).~   "
96969|NCT01787786|"~     The purpose of this study is to develop a predictive model that will allow optimized dosing~     of infliximab for individual patients~   "
96970|NCT01787773|"~     This is a prospective, multicenter single arm, nonrandomized study that will include 150~     patients at a maximum of 20 investigational sites. It is estimated that it may take 13~     months to complete enrollment. Follow-up will continue through 24 months post-implant or one~     month post-retrieval, whichever occurs first. It is required that filters be retrieved from~     at least 50 patients and the filter is permanent in at least 50 patients.~   "
96971|NCT01787760|"~     This study is to investigate whether novel soft contact lens optical designs can slow myopia~     progression.~   "
96972|NCT01787747|"~     To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of~     AVP-786 in healthy volunteers.~   "
96973|NCT01787721|"~     The purpose of this study is to determine if manipulation of the ankle improves some~     measurable characteristics of how a person walks. The investigators hypothesize that the~     ankle will be able to bend better after manipulation and thus improve walking speed and~     reduce differences between the two limbs.~   "
96974|NCT01787708|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. There are many treatment modalities available for vitiligo,~     however, none of them cure the disease. Visible red light has been shown to stimulates~     melanocyte migration and proliferation resulting in repigmentation of vitiligo patches.~     However, there are only a few studies published on the efficacy of red light in vitiligo.~     This is a prospective single-blind randomized clinical trial to assess efficacy of red light~     in the treatment of vitiligo.~   "
96975|NCT01787695|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. There are many treatment modalities available for vitiligo,~     however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to~     be useful for a variety of skin diseases. However, there are only a few studies published on~     the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical~     trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.~   "
96976|NCT01787682|"~     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic~     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,~     treatment response and survival. Loss of muscle protein is generally a central component of~     weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone~     density, independent of the severity of the disease state. The purpose of this~     cross-sectional study is to provide detailed insight in disease related gut function by~     obtaining information on gut permeability, digestion and absorption of glucose, fat and~     protein in CHF and COPD patients compared to matched healthy controls. This will provide~     required information that is necessary to implement new strategies to develop optimal~     nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to~     decreased gut function and absorption, leading to decreased anabolic response. Second, this~     decreased nutritional status is linked to reduced muscle functioning and possibly decreased~     cognition. In addition, we will examine the effect of aging on by comparing gut function~     digestion and absorption of the CHF and COPD aged matched healthy controls to a group of~     young healthy subjects.~   "
96977|NCT01787669|"~     The specific aim of the study is to test the following hypothesis:~      That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with~     diabetic macular oedema with no or incomplete response from one therapy is beneficial.~   "
96978|NCT01787656|"~     Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival~     are low. There is a current belief that this cancer starts in the fallopian tubes and~     progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian~     tubes and the uterus, there is a constant flow of mucus which has only one exit through the~     cervix and out the vagina. Proteins that are generated within the entire female reproductive~     system are trapped into this viscous fluid and eventually released as waste. When a routine~     PAP test is performed, a sample of this mucus is collected along with any cells, and~     preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile~     showing of the status of the cells in the female reproductive system. We have examined this~     fluid and found that it contains unique peptides/proteins that provide a diagnosis of~     ovarian cancer when compared against healthy controls. These markers will be initially~     refined using the comparison of ovarian cancer patients against those with benign adnexal~     masses that entered the clinic during the same time period.~      In this Phase II biomarker validation study we will further refine and validate these~     biomarkers using a new collection of samples from at least 200 ovarian cancer cases with~     epithelial ovarian cancer (endometroid and papillary serous histology, most common) and~     comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter~     the clinics during the same time period. Patient samples will be collected on their first~     visit to the gynecologic oncologist at a number of collaborating clinics. Final processing~     of all of the samples will be performed within the proteomics research facilities of the~     Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry)~     based on the refined set of makers statistically selected within the first aim. Biomarkers~     validated within this study will be compared with the well accepted CA-125 data for the~     patients. The research involves a three year validation and may allow detection of this~     cancer at a very early stage when the survival is as high as 90%. One aim examines a~     self-taken test that could allow its use in medically underrepresented and rural areas.~   "
96983|NCT01787591|"~     This study is conducted to investigate if vitamin E status in healthy individuals and~     individuals with metabolic syndrome can be improved by dairy fat. The investigators~     hypothesize that full-fat dairy will substantially increase the bioavailability of~     alpha-tocopherol, a form of vitamin E. The results of this study will contribute to the~     application of dairy fat as a simple and effective strategy for improving vitamin E status,~     which is partly due to poor vitamin E intake. By completing this study, the investigators~     anticipate developing new dietary recommendations to achieve adequate vitamin E status~     through the regular consumption of dairy fat paired with foods containing vitamin E.~   "
96984|NCT01787578|"~     The purpose of this study is to assess the safety, tolerance, pharmacokinetics, and~     pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male X-ALD~     patients.~   "
96985|NCT01787565|"~     The aim of this investigation is to determine whether the use of painPREMIER will~     significantly improve function in patients with low back pain in an occupational health~     clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of~     back pain and associated problems in order to treat them most effectively.~   "
96986|NCT01787552|"~     The purpose of this phase Ib/II clinical trial is to: a) evaluate the safety of the~     co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum~     tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the~     efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.~   "
96987|NCT01787539|"~     Taking into account the substantial doubts concerning the potential benefit of postoperative~     part in the perioperative chemotherapy regimen we designed a study assessing value of this~     approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive~     combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and~     better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX~     regimen will be tested in patients with locoregionally advanced gastric cancer with positive~     pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients~     will be randomized to the postoperative chemotherapy or to the follow-up arm.~   "
96988|NCT01787526|"~     2-3% of the population participates in blood donation programmes. Traditionally, safety~     issues in transfusion medicine have been concentrating on product and recipient safety.~     Extensive efforts including strict donor inclusion criteria and testing for important~     transmissible infections have substantially improved product quality. One of the most common~     risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular~     blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron.~     Although this has been known for at least 50 years, iron deficiency is not routinely~     assessed or treated in this population. Contributing factors include donation frequency,~     lower weight and female gender. Women have lower iron reserves and in premenopausal women,~     the daily required amount of iron is higher than in men. Besides anemia, iron deficiency may~     lead to fatigue and impaired cognitive and physical performance. Oral iron substitution is~     often associated with significant gastrointestinal side effects leading to poor compliance.~     Today, intravenous (iv.) iron preparations are well tolerated and allow the application of a~     large dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron~     deficiency intravenous iron is feasible and preferable to oral iron because of its high~     efficacy and optimal compliance with a similar safety profile that has been extensively~     studied in other populations than blood donors.~   "
96989|NCT01787513|"~     A randomised controlled trial comparing Internet based cognitive behavioural therapy for~     major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A~     vs. Internet based cognitive behavioural therapy for major depressive disorder plus a~     cognitive bias modification intervention (OxIGen) version B on symptoms of depression and~     negative interpretation bias.~   "
96990|NCT01787500|"~     The goal of this clinical research study is to find the highest tolerable dose of~     vemurafenib that can be given in combination with cetuximab and irinotecan to patients with~     advanced cancer. The safety of this drug combination will also be studied.~      Vemurafenib is designed to block BRAFV600 inside the cancer cells, which is involved in~     cancer cell growth.~      Cetuximab is designed to block proteins inside the cancer cell, which may prevent or slow~     the growth of cancer cells and leads to cell death.~      Irinotecan is designed to stop cancer cells from making new DNA (the genetic material of~     cells). If the cancer cells cannot make DNA, they cannot divide into new cells and may die.~   "
96991|NCT01787487|"~     The goal of this clinical research study is to learn if the combination of ruxolitinib and~     azacytidine can help to control myelofibrosis and myelodysplastic~     syndrome/myeloproliferative neoplasm.~      Ruxolitinib is designed to block a pathway that has been found to be overactive in human~     cancers and myelofibrosis.~      Azacytidine is designed to block certain proteins in cancer cells that stop the function of~     the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting genes may be~     able to work better.~   "
96992|NCT01787474|"~     The goal of this clinical research study is to learn about the safety and effects of giving~     special kinds of immune cells, called natural killer (NK) cells, with high dose chemotherapy~     to AML patients. Researchers want to learn the maximum tolerable number of NK cells that can~     be given. These NK cells may react against the leukemia cells, particularly when they are~     mismatched for certain HLA tissue type proteins.~      In addition to NK cells, you will receive cytarabine and fludarabine to try to kill any~     cancer cells and prevent rejection of the NK cells.~   "
96993|NCT01787461|"~     The study hypothesis is that Imedeen will show effects on skin health, when compared to~     placebo over a 6 month intervention period with respect to changes in skin appearance, skin~     density, moisture, and in fine lines and wrinkles.~   "
96994|NCT01787448|"~     This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its~     vehicle gel to cause sensitization after repeated topical application to healthy skin of~     human subjects under controlled conditions.~   "
96995|NCT01787435|"~     The purpose of this study is~        1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs)~          and the risk of asthma during childhood.~        2. To estimate the association between prenatal exposure to H2-receptor antagonists~          (H2RAs) and the risk of asthma during childhood.~   "
96996|NCT01787422|"~     This study is to determine if telemedicine visits provide similar quality and~     patient/physician satisfaction as traditional office visits in a college health population.~   "
97001|NCT01787357|"~     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on~     electrocardiogram results (recordings of the electrical activity of the heart) in healthy~     volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4~     times higher [1,200 mg] than the anticipated therapeutic dose of 300 mg). The safety and~     tolerability of canagliflozin will also be assessed.~   "
97002|NCT01787344|"~     To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South~     Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral~     palsy in children.~   "
97003|NCT01787331|"~     This study is being done to test an investigational drug called itraconazole in the~     treatment of prostate cancer.~   "
97004|NCT01787318|"~     This research study designed to look at how well adolescents' and young adults' blood sugars~     can be controlled with a closed loop artificial pancreas using a continuous glucose~     sensor, an insulin pump, and a computer program that automatically determines how much~     insulin to give based on the glucose level. The investigators will also study the effect of~     wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the~     ability of the closed loop system to control the blood sugar levels and to reduce the rise~     in glucose levels after meals.~   "
97005|NCT01787305|"~     The purpose of this study is to explore if certain commensals within the gut microbiota (the~     collection of all microbes that live inside the gut) correlate with autoantibodies in the~     autoimmune clotting disorder called antiphospholipid syndrome. The study hypothesis is that~     particular commensals induce the autoantibodies (immune molecules that bind to self~     structures) and thus correlate with the level of immune cells and antibodies that are~     self-reactive. Participants are patients with antiphospholipid syndrome and individuals who~     have tested positive on a prior blood test for anti-beta2-glycoprotein I antibodies or those~     that have tested negative for antiphospholipid antibodies in their blood, but had a clotting~     event or a health problem that puts them at risk to form blood clots.~   "
97006|NCT01787292|"~     The purpose of this research study is to test whether differing levels of physical fitness~     affects patterns of motor dexterity and brain activity that have been shown to differ due to~     aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.~      Participants will be healthy adults within the target age range of 60-85 for the study. The~     study will require multiple visits over 15 months. There will be about 64 people~     volunteering for this study.~   "
97007|NCT01787279|"~     This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to~     patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys~     180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during~     treatment and for 24 weeks of follow-up.~   "
97008|NCT01787266|"~     The purpose of this study is to:~        1. describe degree of symptoms and disability during and after pregnancy~        2. to examine if women with pelvic girdle pain are able to correctly mark their pain~          location on a pain drawing~        3. to examine the responsiveness of The Pelvic Girdle Questionnaire~   "
97009|NCT01787253|"~     Objective: This study aims elucidate the pathophysiological link between the environment in~     the colon (mainly the microbiota), the local immune system and activation of the enteric~     nervous system in patients with post-infectious IBS (PI-IBS) and microscopic colitis (MC)~     with special emphasis on microbial-mucosa interactions and evaluation of the effect on the~     immune activation/response as well as how afferent gut-brain signalling leads to abdominal~     discomfort.~      Method: The project is based on data from three cohorts of patients, one with PI-IBS and one~     with MC as well as a gender- and age-matched cohort of healthy individuals. Measurement of~     perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress~     using a barostat. The HIT (Human intestinal Tissue)-Chip array will be used to characterize~     the diversity, stability and functionality of the intestinal microbiota on mucosa level,~     giving a clue to the interactions with the host and insight to changes leading to the~     development of the two diseases.~      Immunohistochemistry and flowcytometry will be used to analyse the location, frequency and~     phenotype characteristics of lymphoid- and mast cells. Functional analysis of mucosal~     lymphocytes activated in vitro by products from the intestinal microbiota will be examined~     by cytokine production using the LuminexTM system. The Ussing chamber technique will allow~     investigation of the impact of the microbiota and its metabolites on intestinal barrier~     functions. In this method the sample has access to stressors under standard conditions.~   "
97010|NCT01787240|"~     We are doing this research study to find out if people who get better while taking a~     specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or~     SSRI) and people who get better while taking placebo (an inactive substance) have similar~     chemicals in their brains. Some participants may complete a procedure called Acute~     Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression.~     Some participants may also undergo a magnetic resonance-positron emission tomography~     (MR-PET) scan.~   "
97011|NCT01787227|"~     xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial~     DNA / RNA in clinical specimens (nasopharyngeal swabs).~      The objective of this study is to establish diagnostic accuracy of the xTAG RPP.~   "
97012|NCT01787214|"~     Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that~     may lead to a higher risk of developing heart disease. An important part of diabetes~     management involves eating a diet to prevent large swings in blood sugar levels. Walnuts~     contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of~     this study is to compare the effects of a walnut-free American Diabetes Association (ADA)~     diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and~     female adults with T2DM will participate in the study. Subjects will be randomized to~     consume an ADA diet with or without walnuts for 3 consecutive days every other week.~     Subjects must test their blood sugar twice daily and wear a continuous glucose monitor~     during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and~     will be recruited from the surrounding community using flyers and public service~     announcements. Consent will take place in the Department of Nutrition at Loma Linda~     University by the study investigators. In total, subject participation will last 5 weeks and~     all meals will be provided during the 3 study periods.~   "
97013|NCT01787188|"~     The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and~     effective for the treatment of osteoarthritis pain of the knee or hip.~   "
97015|NCT01787162|"~     Goal of the study is to assess the frequency of pulmonary hypertension in patients with~     chronic myeloproliferative diseases. In each patient an echocardiography at rest will be~     performed. In patients without musculoskeletal disease an exercise test (spiroergometry)~     will be performed. Patients with elevated SPAP at rest or with reduced exercise capacity~     (peak VO2 < 65%) a right heart catheterization (RHC) will be recommended. Also patients with~     advanced NYHA functional class (III or IV) or with typical PH findings in electrocardiogram~     will be advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6~     MWD will be performed.~      This work- up of patients allows clinical and hemodynamic evaluation.~   "
97016|NCT01787149|"~     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,~     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs~     versus DMARDs Alone in Patients with Rheumatoid Arthritis~   "
97017|NCT01787136|"~     Dextromethorphan added on methylphenidate for the patients with attention deficit~     hyperactivity disorder~   "
97018|NCT01787123|"~     This is a randomized, placebo-controlled, single-center clinical trial investigating the~     effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a~     preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving~     the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage (~     SAH).~      Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple~     lipid-soluble active agents that can cross the blood-brain barrier. It is a registered~     medication in several countries indicated for stroke and Alzheimer's disease. It contains~     several low molecular weight neuropeptides and free amino acids that possess neuroprotective~     and neurotrophic properties. It has been proven to arrest or mitigate several crucial steps~     along the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively~     investigated in patients suffering from Alzheimer's disease, brain trauma and ischemic~     stroke with promising clinical results. It's use in SAH patients has never been investigated~     and it is believed that it may play a role in improving clinical outcomes.~      Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid~     hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one~     of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of~     care (intervention group) or (2) to receive usual standard of care alone (control group).~     Permuted-block randomization will be carried out once the eligibility criteria have been~     fulfilled using a computer system with an allocation list of random order. Instructions on~     study arm allocation will be contained in sealed envelopes labeled with sequential study~     numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and~     randomization cannot be performed within this time period will be excluded. The reason being~     that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days~     after aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise~     before Cerebrolysin™ is administered there would be significant confounding of trial outcome~     measures . The timing of intervention is in keeping with several landmark clinical studies~     that have dealt with neuroprotective agents in subarachnoid hemorrhage.~      Patients in the intervention group will receive in a daily total dose of 30ml of intravenous~     Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every~     eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous~     infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride~     (NaCl) saline (100 ml) will be used as placebo for patients allocated to the control study~     group. The total duration of study medication or placebo administration will be 14 days.~      Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the~     preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap~     as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™~     solution will be performed by ward nursing staff . Subjects in both trial groups will~     receive identically wrapped preparations so that both the functional outcomes assessor and~     patient are blind to the study arm allocation.~      In addition to general demographic data, clinical data including the admission Glasgow Coma~     Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score~     and modified Rankin Score upon discharge, at three months and six months will be~     prospectively collected. The functional outcomes assessor will be an occupational therapist~     unaware of the subject's trial group allocation.~      Hypothesis: compared to patients receiving standard care for the management of aneurysmal~     subarachnoid hemorrhage alone (control), the additional administration of intravenous~     Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves~     functional outcome at six months after stroke.~   "
97019|NCT01787110|"~     The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI)~     is manifested in international treatment guidelines and established in prehospital and~     hospital clinical routine throughout the world.~      However, to date there is no conclusive evidence from adequately designed and powered trials~     supporting this practice. Existing data is conflicting and failing to clarify the role of~     supplemental oxygen in AMI.~      The DETO2X-AMI trial is designed to shed light on this important issue.~   "
97020|NCT01787097|"~     The purpose of the research (or knowledge gap this research is designed to fill) is to~     understand the science of how the combination therapy of 2 drugs (inhaled longacting~     beta-agonists(LABA) and inhaled corticosteroids (ICS), which are commonly used in chronic~     obstructive pulmonary disease (COPD) patients, is better than each drug alone. ICS and LABA~     both have antiinflammatory properties; that is, they dampen the inflammation in the cells of~     the airways in the lungs. The combination of LABA and ICS has also been shown to improve~     clinical effectiveness in asthma patients. The addition of a LABA to LOW doses of ICS has~     been shown to be more clinically beneficial in asthma than the use of HIGH doses of ICS~     alone. This has allowed a reduction in the total ICS dose and minimised the adverse side~     effects of inhaled corticosteroids. Recent evidence suggests that the use of combination~     therapy of LABA and ICS may also improve clinical effectiveness in COPD patients.~      Investigators will address this hypothesis by examining the inflammation cells of COPD~     direct from the site of disease (the airways) by looking at sputum/mucus. This research will~     build on the existing knowledge of the science of how these drugs work in asthma and COPD~     and allows us to understand the molecular science, which may support new future drug targets~     for patients with COPD, which are greatly needed.~   "
97021|NCT01787084|"~     Investigational study of Edwards Lifesciences, LLC's Edwards SAPIEN Transcatheter Heart~     Valve for non-femoral delivery, (or alternative access deliver) in patients with severe~     symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be~     inoperable for open aortic valve replacement and in whom existing co-morbidities would not~     preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed~     in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN~     device compare to inoperable patients undergoing alternative access TAVR with the Edwards~     SAPIEN device experience a reasonably similar incidence of 30 day adverse events?~   "
97022|NCT01787071|"~     Fluids are one of most common therapies used in critically ill patients. Fluids are the~     cornerstone of hemodynamic management. In overt bleeding, fluids are often given without~     guidance with specific haemodynamic monitoring. In other conditions when hypovolemia may be~     more subtle or when the response to fluids is more variable, fluids are often given in a~     more titrable way, monitoring their haemodynamic impact. This practice, called the fluid~     challenge technique has been proposed by Max Harry Weil more than 30 years ago [1].~      The fluid challenge has been used in several papers and studies assessing the response of~     patients to fluids. The way this practice is performed varies in terms of type of fluid,~     volume of fluid, rate of fluid administration, and clinical endpoints used.~      There is no data that describe how fluid challenges are administered in ICU's across the~     world. Understanding this will provide valuable information regarding current practice and~     would be a basis for improving current practice and future research.~      The way fluids are administered vary widely. Indications for fluids and monitoring of the~     effects are not standardized and may thus lead to heterogeneity in practice. In addition,~     several patients may fail to respond to fluids. The purpose of this observational study is~     to evaluate how fluids are administered and to identify the factors associated with a~     positive response to fluids. Better characterizing these practices and the patients who~     benefit from fluids would set the basis of further interventional trials trying to optimize~     fluid administration.~      What does this study involve?~        1. All patients enrolled in the study will receive standard clinical care~        2. Data will be collected in order to study how fluid challenges are performed in ICU's~        3. No extra tests will be performed for this study~        4. Only measurements and data available as part of clinical practice will be collected~   "
97023|NCT01787058|"~     This study will use longitudinal data collection to quantify the impact of a school-based~     water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism,~     diarrheal illness, and respiratory illness.~      Data will be collected from 100 intervention and 100 control schools across 4 regions in~     Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically~     ages 7-14). Research staff will ask school directors to provide written consent for pupil~     participation in place of parents, a procedure that has been approved by the Malian Ministry~     of Education. Research staff will approach selected pupils at school to request informed~     oral assent for participation. The informed assent process and data collection will be~     conducted by local trained enumerators in the child's preferred language of French or~     Bambara. Oral rather than written assent was chosen due to varied literacy capabilities and~     to limit paperwork that identifies participants.~      Data collection will take place at each school once every six to eight weeks during the~     duration of two school years. Research staff will conduct observations of school facilities,~     observations of handwashing behavior of children upon leaving latrines, and an interview~     with the school director about WASH conditions and school enrollment information. None of~     these school activities collect personal data or identifiers. Data collection with pupils~     will be done with the same pupils every 6-8 weeks and entails a 5-minute interview asking~     about recent absence and symptoms of diarrhea and respiratory illness.~      All data collection will occur at the school, will be conducted by trained local~     enumerators, and will be stored on password-protected mobile data collection devices. Data~     will be uploaded to a password-protected server and will not contain personal identifying~     information. Enumerators will maintain a separate form that links pupil IDs with names,~     which will be kept confidential. There are no direct benefits other than contribution to~     general knowledge that will inform future school WASH projects. There are no risks to~     participation other than a small amount of class time missed by pupils, and great efforts~     will be made to minimize time outside of class.~   "
97037|NCT01786876|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of [14C]~     SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study~     is to investigate how and how quickly SPD557 or its break down products are excreted by~     analysing blood, faeces and urine samples collected during the study.~   "
97038|NCT01786863|"~     This study is designed to investigate the frequency of Residual Neuromuscular Blockade~     (RNMB) in the pediatric population.~   "
97024|NCT01787045|"~     It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or~     multi organic failure are very susceptible to develop neuromuscular complications. That can~     be attributed to a hyper catabolic state, general inflammation and immobilization. This can~     leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have~     been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important~     functional squeals and impaired quality of life for months, years and in some cases~     irreversibly.~      To overcome these complications, early activation by physiotherapy becomes an important~     tool. This type of treatment has been show to be feasible, safe and improves the functional~     capacity of patients. In addition to a reduction in the duration of ICU and hospital stay~     and improved quality of life for patients.~      The objective of this study is to demonstrate that the early and active physical activity in~     patients with severe sepsis can limit the loss of muscle mass and complications related to~     this type of damage.~      Procedures: Patients or relatives will be asked to participate in the study. If a positive~     response is done, patients will be randomized in an intervention or control group.~      A baseline evaluation will be performed during the first day of study admission. That~     includes a physical exploration, electrophysiological studies, skeletal muscle~     histological/biochemical evaluations and monitoring of blood biomarkers and others clinical~     outcomes will be registered.~      Intervention will be divided in a morning and afternoon times, patient will be positioned in~     chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining~     manual mobilization for 20 minutes twice a day. Only for intervention group, additional~     cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and~     tolerated for patient. All vitals parameters will be strictly controlled before, during and~     after intervention.~      The same baseline evaluation will be repeated after day 7 and clinical outcomes will be~     registered until ICU discharge.~   "
97025|NCT01787032|"~     The primary objective of this trial is to investigate the relative bioavailability of a~     single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady~     state. The assessment of safety and tolerability of BI 113608 administered alone and upon~     co-administration will be an additional objective of this trial.~   "
97026|NCT01787019|"~     The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed~     to tube) feedings in premature infants results in earlier attainment of full oral feedings~     and/or discharge.~   "
97027|NCT01787006|"~     Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from~     chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall~     survival rates for this disease remain poor.~      During the last years the combination of cetuximab with standard chemotherapy or~     radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or~     head and neck cancer.~      The results obtained from theses studies were very encouraging and led to the initiation of~     active clinical research in esophageal cancer patients with antibody inhibition of the EGFR.~      The first data in this indication are encouraging showing that cetuximab can safely be added~     to chemoradiation for esophageal cancer patients with first hints of efficacy.~      Based on the experiences with cetuximab in colorectal cancer and in combination with~     radiotherapy in head and neck cancer, the aim of the present study is to evaluate the~     feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin~     and radiotherapy in patients with esophageal cancer and to assess if the overall survival~     rates can be increased by addition of an EGFR-targeted therapy.~   "
97028|NCT01786993|"~     This IDE study is a prospective, randomized, double-blind, multi-center clinical study to~     evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment~     with standard BiV pacing at 9 months.~      The study will be conducted at a maximum of 50 investigational centers located in the United~     States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization~     therapy device (CRT-D) system will be enrolled in the study.~   "
97029|NCT01786980|"~     Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after~     curative resection. Establishing an effective prognostic evaluation method is able to not~     only assess patients' prognosis but also guide the treatment. At the same time, it helps us~     to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and~     to provide the basis for the search for new effective intervention method.~      In order to establish an effective prognostic evaluation method, we select liver cancer~     patients undergoing curative resection in our hospital. We plan to employ various~     technologies such as gene chip, methylation chip and flow cytometry to carry out~     comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor~     microenvironment changes. By analyzing clinical information including pathological features,~     patients' response to treatment, relapse, metastasis and survival, we aim to obtain the~     important factors affecting liver cancer prognosis, survival, recurrence and metastasis in~     order to be able to find and establish the effective prognostic evaluation method.~   "
97030|NCT01786967|"~     Urge urinary incontinence, characterized by unpredictable and embarrassing large volume~     urine leakage, is a major health issue for elderly women, as it is incredibly common and~     significantly impairs quality of life. Although anticholinergic medications are the most~     common therapy, the investigators are unable to predict an individual's response to a~     particular drug in terms of both effectiveness and side effects. Through genetic evaluation,~     the investigators have the potential to personalize and optimize drug therapy for millions~     of elderly women suffering from urge incontinence.~   "
97031|NCT01786954|"~     The purpose of the study is to compare the measurement of pressure inside the eye using~     three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).~   "
97032|NCT01786941|"~     Elevated circulating levels of certain amino acids (the building blocks of protein) are~     strongly associated with insulin resistance. This study will investigate the metabolism of~     these amino acids in individuals with normal glucose metabolism compared to overweight or~     obese pre-diabetic individuals. The purpose of this study is to determine how elevated~     levels of the branched-chain amino acids may contribute to the development of insulin~     resistance and ultimately diabetes. An additional purpose is to determine whether exercise~     or gastric bypass (GBP) surgery intervention can correct aberrations in branched-chain amino~     acid metabolism as insulin sensitivity improves. This information will be used to further~     our understanding of the development of insulin resistance and type 2 diabetes in at-risk~     populations and potentially improve clinical treatment of such conditions.~   "
97033|NCT01786928|"~     The purpose of this study is to determine whether resistance exercise are effective in~     combating the decline in muscle strength during an exacerbation of Chronic Obstructive~     Pulmonary Disease (COPD).~   "
97034|NCT01786915|"~     The purpose of this study is to assess the study medication blood levels after~     administration of a repeat oral capsules (one capsule each day for seven days) of Bendavia~     at one of two dose levels. The effects of Bendavia on the volunteers will also be assessed.~   "
97039|NCT01786850|"~     Patients with unresectable pancreatic cancer in most of cases cannot benefit from~     percutaneous ablation modalities, due to high risk of procedure-related complications.~     Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a~     feasible treatment option in these patients. However, in other anatomical regions US-guided~     HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation,~     but the applicability of this latter technique to the treatment of pancreatic cancer is~     still unexplored. The aim of this study is to explore feasibility and clinical performance~     of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain~     palliation and local tumor control.~      As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate,~     non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no~     cases of pancreatic MRgFUS ablation have been reported.~   "
97040|NCT01786837|"~     The purpose of this study is to evaluate the effects of Functional Magnetic stimulation~     (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to~     non-neurological issues.~   "
97041|NCT01786824|"~     The general objective of this open, pilot study is to characterize biological parameters~     related to acute kidney injury among patients undergoing a programmed coronarography with~     injection of contrast material. The study focuses on two main factors that may influence~     acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate~     hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral~     L-carnitine treatment. We will also test for a potential interaction between these two~     factors.~   "
97042|NCT01786811|"~     The purpose of the study is to evaluate the impact of implementing a Serious Illness~     Conversation Guide to guide patient/family-clinician discussions and planning about~     end-of-life care decisions. The goal of the intervention is to improve achievement of~     patient care priorities and peacefulness at the end of life for patients with serious and~     life-threatening illness and their families. We hypothesize that patients whose physician is~     trained to use and adheres to the elements of the Serious Illness Conversation Guide will~     demonstrate enhanced consistency between documented key priorities and care received, and~     will experience greater peace in the final month of life; similarly, their families will~     experience higher satisfaction with care.~   "
97043|NCT01786798|"~     The objective of this study is to investigate the role of transvaginal ultrasound in~     detecting endometrial hyperplasia and endometrial cancer in women aged more than 35~     presenting with abnormal uterine bleeding.~   "
97044|NCT01786785|"~     Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top~     ten causes of death in children. Currently, caregivers lay the affected child flat in hopes~     of increasing blood flow to the brain and reducing the volume of the brain which is damaged.~     However, there are currently no techniques to measure brain blood flow at the child's~     bedside and indicate if this treatment is effective. We will probe brain blood volume,~     oxygen saturation, and flow with red light to determine the efficacy of this intervention.~   "
97045|NCT01786772|"~     To determine changes in quadriceps muscle function following the application of ice and~     compression to the knee.~   "
97046|NCT01786759|"~     The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought~     to be multifactorial, and proposed theories also include problems arising from lipid~     emulsions, leading us to explore alternative products available elsewhere.So we compare the~     different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic~     tolerance in preterm infant.~   "
97047|NCT01786746|"~     The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is~     effective in treating depressed Chinese Americans, b) to develop and test the effectiveness~     of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.~   "
97048|NCT01786733|"~     The purpose of this study is to compare the effectiveness of Behavioral Activation and~     Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts~     during inpatient care and can continue in an outpatient facility if the patients are~     discharged before 12 sessions has been completed.~   "
97049|NCT01786720|"~     The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease~     (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these~     following research questions:~        1. The percentage of patients prescribed triple therapy, and when they first started~          receiving triple therapy.~        2. For patients prescribed triple therapy, the time taken to triple therapy from initial~          diagnosis of COPD.~        3. The variation in treatment pathways.~        4. The factors associated with time taken to triple therapy.~   "
97050|NCT01786707|"~     A prospective, open labeled, randomized controlled clinical trial comparing the benefit of~     both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical~     treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical~     treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will~     be randomized into either the intervention group or the control group:~   "
97051|NCT01786694|"~     The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy~     in order to identify anastomotic leaks after rectal surgery.~   "
97052|NCT01786681|"~     The aim of this study was to investigate the effects of using positive pressure in the~     preoperative, intraoperative and postoperative morbidly obese individuals undergoing~     gastroplasty.~      It is believed that the application of these devices before, during or after surgery can~     help to improve the lungs and reduce pulmonary complications after surgery to reduce the~     stomach.~   "
97053|NCT01786668|"~     This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It~     is designed to obtain information on the efficacy and safety of 3 different doses of~     tofacitinib.~   "
97054|NCT01786655|"~     The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel~     prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection~     in combination with the commonly used local anesthetic, bupivacaine, and epinephrine.~      The investigators hypothesize that a minimal adverse effect threshold NeoSTX dose for~     subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml~     respectively, can be defined for awake, young adult healthy volunteer subjects. At the same~     time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.~   "
97057|NCT01786616|"~     Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to~     salmeterol in asthmatics. Data concerning formoterol are more controversial in literature.~     The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and~     homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term~     responsiveness to formoterol.~   "
97058|NCT01786603|"~     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons~     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and~     loss of muscle function. Motor neurons are responsible for sending signals to muscles in our~     bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is~     no cure for ALS.~      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means~     that the nervous system may be protected against weakening. It is known that rasagiline has~     possible neuroprotective characteristics, but the effectiveness of rasagiline for patients~     with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's~     disease.~      Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration~     (FDA) and is investigational. Investigational drugs are studied to find out if they are safe~     and effective in the treatment of diseases or conditions.~      By doing this study, researchers hope to learn if rasagiline is safe and slows disease~     progression in patients with ALS.~      Funding Source - FDA OOPD.~   "
97059|NCT01786590|"~     It is reported that more than 90,000 patients died of lung cancer and more than 20% of them~     were older than 80 years in North America. Therefore a less invasive but effective treatment~     is required for patients with lung cancer of advanced age, diminished pulmonary functions,~     and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and~     well-tolerated treatment for early stage lung cancer in medically inoperable patients. On~     the other hand, accurate mediastinal and hilar lymph node staging is one of the most~     important factors that determine the outcome and indications for SBRT. Endobronchial~     ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally~     invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a~     high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for~     high-risk patients with lung cancer to undergo minimally invasive treatment.~   "
97060|NCT01786577|"~     The purpose of the study is to examine specific neuroimaging predictors of memory and~     executive decline in older adults at various stages after total knee replacement surgery.~   "
97061|NCT01786564|"~     The purpose of this study is to determine if deficient sleep and/or disruption with the~     body's internal clock (circadian rhythms) are associated with diabetes risk. This study is~     being done to look at the possible relationships between sleep and risk of diabetes by~     examining sleep in the home and diabetes risk in the laboratory.~   "
97062|NCT01786551|"~     The purpose of this project is to investigate the effect of mineralocorticoid receptor (MR)~     blockade in healthy subjects on the systemic proinflammatory state after a meal high in fat~     and glucose.~      Subjects will include normal weight, healthy male subjects (BMI ≤ 25 kg/m2) between the age~     of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any~     other kind of diseases. After a 12h fast, subjects will be assigned to a combination of oral~     fat loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two~     week treatment with 50 mg eplerenone. After two weeks, subjects will receive the second~     OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the~     participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day.~     Standardization of sodium intake is necessary as variations in dietary sodium intake may~     affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of~     the study. Prior to OFLT/OGTT, and 2h, 4h thereafter we measure a parameter of vascular and~     systemic inflammation: IL-6~   "
97063|NCT01786538|"~     Regorafenib has been proved to improved survival in patients with metastatic colorectal~     cancer who have been failed to all of known standard chemotherapy (The CORRECT study). The~     phase Ib study of regorafenib plus FOLFOX or FOLFIRI was performed and the dose of~     regorafenib was fixed; 160 mg/day on days 4 to 10 (7 days per cycle when combined with~     FOLFOX or FOLFIRI). Regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who~     progressed after first-line irinotecan-based chemotherapy has not been studied yet, and~     because there have been unmet needs for the discovery of valid targeted agent combination~     for the second-line FOLFOX as above reasons, the investigators planned this study of~     regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after~     first-line irinotecan-based chemotherapy.~   "
97064|NCT01786525|"~     The main purpose of this research program is to reduce the burden of end-stage organ disease~     on individuals, families, healthcare systems, and society by increasing the availability of~     donor organs for transplantation. Consistent with this aim, the project further examines~     strategies to increase access to and reduce disparities - racial, economic, gender - in live~     donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of~     an innovative House Calls intervention developed by the principal investigator by including~     other minorities and socioeconomically disadvantaged patients and by adding a novel~     Patient-Centered Decision Support component. The main study hypothesis is that participants~     receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have~     a higher proportion of LDKT's by the 2-year study endpoint.~   "
97065|NCT01786512|"~     The primary objectives of this study are (i) to select an oral modified release (MR)~     formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects~     with HF and left ventricular systolic dysfunction and (ii) to characterize its~     pharmacokinetics (PK) over 20 weeks of treatment.~   "
97103|NCT01786018|"~     The purpose of this study is to evaluate progression free survival, transplant-related~     morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic~     GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated~     with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.~   "
97213|NCT01784666|"~     This study investigates the medication isradipine, which is currently approved by the FDA to~     treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or~     placebo (contains no active medication) will be used as an add-on to lithium, valproate,~     and/or atypical antipsychotics for individuals currently experiencing a major depressive~     episode. Our hypothesis is that isradipine will be superior to placebo in improving~     depressive symptoms.~   "
97066|NCT01786499|"~     Hypothesis: Relaxation Response training is an effective intervention in reducing the~     prevalence and severity of burnout and its components from baseline levels among physicians~     receiving the training intervention. The intervention is hypothesized to moderate the~     relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to~     cope with the demands of their workplace. This increased coping ability is hypothesized to~     reduce burnout.~      Physician practices are as unique as the individual practitioners and the environment in~     which they practice. Traditional instruction of relaxation or self-care techniques has~     required participants to travel to locations remote from the workplace. The time commitment~     required for this behavior is additive to the time required to learn the intervention and of~     itself may induce extra stress increasing the potential for burnout. This study proposes~     that bringing the intervention to the workplace will increase provider willingness to~     participate and diminish the stress introduced by deployment of the intervention. Since~     inpatient and outpatient medicine have different practice characteristics and demands on the~     time of the practitioners, this study will need to develop and test the logistics necessary~     to bring the training to the different physician populations.~   "
97067|NCT01786486|"~     The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to~     evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in~     subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or~     more years post implant.~   "
97068|NCT01786473|"~     The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel~     administered once daily (QD, morning dosing) compared to placebo administered once daily~     (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being~     confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment~     aims to restore testosterone levels to normal physiological range.~   "
97069|NCT01786460|"~     The purpose of this study is to use an investigational assay to assess levels of putative~     biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in~     a correlative analysis with data collected under a separate study of severe TBI.~   "
97070|NCT01786447|"~     The purpose of this study is to determine if specific brain injury biomarkers have utility~     as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be~     accomplished by examining the relationships between potential serum-based TBI biomarkers and~     clinical measures of injury severity, occurrence of complications, and outcome, in subjects~     with mild or moderate TBI as well as in orthopedic control subjects.~   "
97071|NCT01786434|"~     Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore~     routinely administered in most countries. In Norway, however, routine sedation is rare, and~     medication is normally given on demand, that is, if necessary during the procedure. The~     investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast~     onset of action, is better given before the procedure than during the procedure.~   "
97072|NCT01786421|"~     The purpose of this study is to determine the impact of alcohol consumption in diurnal~     triglyceridemia in a free living situation.~   "
97073|NCT01786408|"~     This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The~     TAP20-C device collects small amounts of blood from the forearm which can then be used for~     blood testing. The study will also involve collecting blood by fingerstick which is a common~     way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo~     Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the~     concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two~     different blood collection methods. Additional information will be collected about how the~     TAP20-C device performs.~   "
97074|NCT01786395|"~     This study is a multicenter trial performed in Japan, consisting of a comparative study~     period and a continuous administration period.~      Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will~     be verified in 52 weeks comparative study period by a placebo-controlled, double-masked~     study in patients with retinitis pigmentosa.~      The safety of same eye drops will also be examined in 52 weeks continuous administration~     period, in all the patients who completed the comparative study period.~   "
97075|NCT01786382|"~     The primary objectives of the study are to:~        -  Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK)~          profile of midazolam following a single oral dose in human subjects.~        -  Evaluate the potential effects of PPI-668 at steady state on the PK profile of~          omeprazole following a single oral dose in human subject~   "
97076|NCT01786369|"~     This is a screening study aimed at estimating the frequency of antipsychotic non-compliance~     in patients with a history of schizophrenia or other psychotic disorder admitted to an~     inpatient psychiatric unit. Levels of the antipsychotics risperidone, olanzapine,~     quetiapine, aripiprazole, and paliperidone will be drawn in patients presenting the~     emergency room who are acutely psychotic, require admission to an inpatient hospital, have a~     history of psychosis, and have previously been prescribed one of the study drugs. Levels~     will then be analyzed to determine the frequency and severity of non-compliance in this~     population.~   "
97099|NCT01786070|"~     The aim of this study is evaluation of the effect of administration nebulized budesonide~     after extubation. The specific objectives of our study are to determine whether multiple~     doses of nebulized budesonide are effective to reduce or prevent postextubation edema.~      In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who~     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in~     the study after obtaining a written informed consent from their parents or guardians.~      The investigators divide our patients randomly into two equal groups.~      -Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12~     hours; n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48~     hours after extubation. If patient have extubation criteria the investigators will extubate~     him and for 24 hours after, another anesthesiologist who is unaware about kind of~     medication, will evaluate the patients for severity of stridor. We will record the vital~     sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood~     pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before~     aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After~     extubation then the presence of stridor (heard with the aid of stethoscope) was recorded~     within 48 hr of extubation.~   "
97077|NCT01786356|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure~     that uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in~     today's small incision phacoemulsification surgery. Nowadays a multitude of microincision~     IOLs are available, many of them similar but of course with some differences in regard to~     the chemical composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 4 years.~   "
97078|NCT01786343|"~     The goal of this clinical research study is to compare how well 2 different dosing schedules~     of decitabine may help control AML.~      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause~     cancer cells to die.~   "
97079|NCT01786330|"~     This is a pilot study investigating the use of abdominal binders after cesarean sections.~     The researchers are testing whether elastic abdominal binders improve postoperative pain~     control and reduce postoperative blood loss. Blood loss and pain control are both concerns~     after giving birth. It is hoped that the use of an abdominal binder after giving birth will~     provide a non-pharmacologic way to to reduce blood loss and manage pain.~   "
97080|NCT01786317|"~     Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to~     3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution~     manometry to measure anorectal motility~   "
97081|NCT01786304|"~     Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence,~     although its mecanims of action remains poorly understood. The investigators hypothtized~     that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the~     investigators will collect biopsy samples from patients implanted for SNS, and assess~     whether SNS induces changes in ENS.~   "
97082|NCT01786291|"~     Positive airway pressure (PAP) therapy is generally offered to patients with obstructive~     sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by~     preventing apneas and therefore reducing cardiac and pulmonary morbidities. The~     investigators sought to verify this by assessing cardiac and pulmonary function during~     exercise.~   "
97083|NCT01786278|"~     The objective of the study is comparison of the efficacy and safety of palliative therapy~     with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia~     resulting from adenocarcinoma of the esophago-gastric junction.~   "
97084|NCT01786265|"~     The goal of this clinical research study is to learn if treatment with hormone therapy in~     combination with abiraterone acetate and prednisone for 8 months controls the disease better~     than treatment with standard hormone therapy alone.~      Abiraterone acetate is designed to decrease the production of testosterone (male sex~     hormones), which plays a role in causing prostate cancer to grow.~      Prednisone is commonly used to treat prostate cancer and is given along with abiraterone~     acetate treatment to help lower or prevent some side effects.~   "
97085|NCT01786252|"~     Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of~     assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is~     fertilized by sperm outside the body), ovarian stimulation (medications are used to~     stimulate egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected~     directly into the egg).~      Regardless of the ART procedure being performed, the newly fertilized embryo must still~     implant into the mothers endometrium (inner lining of uterus). This implantation process in~     humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine~     infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates~     but the cellular mechanism for this increase is unknown.~      Successful implantation requires the newly fertilized embryo and the endometrium develop in~     a synchronized manner. This coordinated development is accomplished, in part, by proteins~     secreted by the embryo which circulate throughout the maternal bloodstream and alert the~     maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred.~      One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which~     is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know~     that hCG production by the embryo alerts the ovary to continue producing progesterone, a~     hormone required for pregnancy. However, very little is known about the direct effect of hCG~     on the endometrium during early pregnancy in humans.~      Using animal models, hCG has been shown to induce specific changes in the endometrium,~     suggesting that embryo-derived hCG may be priming the endometrium in anticipation of~     implantation. The goal of this research study is to examine the direct effect of hCG on the~     human endometrium and see if this priming effect is also present in humans. Findings from~     this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially~     pregnancy rates.~   "
97086|NCT01786239|"~     This 16-week placebo-control study looks to investigate whether patients with schizophrenia~     for two years or less may benefit from omega-3 supplements.~   "
97087|NCT01786226|"~     Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and~     mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months~     follow-up period.~      The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in~     fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.~   "
97088|NCT01786213|"~     Colon cancer is the second most common cause of death among cancer-related deaths in~     Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy.~     To provide high quality in colonoscopy several quality parameters have been postulated in~     the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data~     suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a~     multitude of circumstances such as bowel cleanness. The facts that detection rates vary~     between colonoscopists suggests that leaning effects may also play a role. It is not known~     how ADR and other quality parameters evolve while trainees improve their skills in~     colonoscopy. The investigators postulate that a learning curve exists. The investigators~     therefore plan to evaluate chronologically the findings of trainee colonoscopists. A~     particular performance in detecting adenomas shall be calculated in relation to the amount~     of examinations performed.~   "
97090|NCT01786187|"~     Little is known about the symptom experience of persons having undergone surgery for lung~     cancer. What we do know is that symptoms are common and can become severe and lasting. The~     main purpose of this study is two-fold:~        1. To better understand the symptom experience of persons with lung cancer prior to~          surgery and for up to six weeks after returning home from the hospital.~        2. To examine the role of a light physical activity program in persons who are undergoing~          surgery for lung cancer for the treatment of a specific symptom.~      The goals of this study include:~        -  Collecting information about the participant's current and prior health history,~          symptoms, and health-related quality of life.~        -  Assessing our ability to recruit participants to the study.~        -  Assessing participant's level of participation.~        -  Evaluating the participant's satisfaction with the program.~      We expect that patients after undergoing surgery for lung cancer during the recovery process~     will experience multiple symptoms. We also expect to find that a light intensity physical~     activity program will be feasible, acceptable, and show a positive impact on symptoms such~     as cancer-related fatigue and confidence for cancer-related fatigue self-management.~      Information gained from this randomized controlled trial study will be used to refine the~     design of future larger-scale studies targeting symptoms such as cancer-related fatigue for~     the lung cancer population.~   "
97091|NCT01786174|"~     The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe~     and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
97092|NCT01786161|"~     Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected~     methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to~     optimize the dosing of vancomycin for this critically ill population. The most efficacious~     method of administering vancomycin is debated in the literature. Since vancomycin is~     associated with slow bactericidal activity, it is important to closely monitor serum~     concentrations so as to achieve early target serum concentration, particularly when treating~     aggressive S. aureus infections. One study has shown that vancomycin infused continuously~     may enable faster and more consistent achievement of a therapeutic serum concentration when~     compared to intermittent infusion. A faster achievement in the goal serum vancomycin~     concentration would be a protective factor for intensive care unit mortality in patients~     with MRSA infection.~      Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a~     vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this~     nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve~     target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram~     with a continuous infusion. The aim is to determine which of the two dosing nomogram is more~     efficient and safer for SICU patients.~   "
97093|NCT01786148|"~     The overall goal of this project is to use technology to improve adherence to antiretroviral~     therapy (ART)and increase access to ART adherence care for those HIV+ persons living in~     rural areas. The LIVE Network audio music program mobile application (app) is innovative,~     practical, portable, and could be rapidly scaled up to address the adherence self-management~     needs of rural groups nationwide. If successful, the impact on HIV care will be immense and~     could transform the delivery of HIV self-management and adherence education by overcoming~     barriers of geographic isolation, transportation, stigma and confidentiality in this~     vulnerable group.~   "
97094|NCT01786135|"~     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and~     tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin~     lymphoma (B-NHL)~   "
97095|NCT01786122|"~     AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for~     patients during treatment for gastrointestinal tumors, breast and non small cells lung~     cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect~     the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two~     parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in~     coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors,~     locally advanced or with metastatic disease, in adjuvant treatment, with Performance~     Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group~     will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a~     second phase in community facilities during the remaining 10 months. MEASUREMENTS: The~     primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by~     the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36)~     overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes~     walking and cardiopulmonary test), muscle strength and progression-free survival and~     overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment.~     ANALYSIS: We will compare between groups mean changes from baseline measurement of quality~     of life questionnaire (QOL) and other variables, on an intention to treat basis, using~     longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up.~     Cost / effectiveness and cost / incremental utility associated to the program wil be~     estimated.~   "
97096|NCT01786109|"~     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no~     effective and safe medications approved for the treatment of abdominal pain associated with~     bowel symptoms in IBS. This study will investigate the effects of an approved medication,~     Dronabinol, on the movement of food through the stomach and colon in subjects with a history~     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).~   "
97097|NCT01786096|"~     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and~     tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory~     B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage~     lymphoblastic lymphoma (B-LBL).~   "
97098|NCT01786083|"~     The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique~     (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically~     ill patients.~      And also to describe and evaluate the process carried out by nurses when implementing the~     PST as a useful tool for care for family caregivers.~   "
97100|NCT01786057|"~     Plantar fasciitis is one of the most common causes of heel pain. This study will be~     performed in the purpose of determination the effects of extracorporeal shock wave therapy~     of gastrosoleus trigger points in patients with plantar fasciitis~   "
97104|NCT01786005|"~     Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron,~     characterized by the rate-dependent increase in muscle tone and increased dry-core~     reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a~     frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be~     accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and~     spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the~     level of the lesion, the duration of its existence from the time before the disease, and~     possible plastic changes in axons and synapses on the affected level. There are two basic~     models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005).~     Cerebral model appears with the direct injury of the brain and is characterized by increased~     excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes~     and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite~     lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due~     to the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as~     well as expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral~     spasticity are extremely difficult corrected by standard medical clinic and physiotherapy~     methods. In this regard, in the world literature actively searched for addi-tional search~     correct this symptom. A new modern methods that could affect the syndrome of spasticity is~     rhythmic transcranial magnetic stimulation (Mori et al., 2009).~   "
97105|NCT01785992|"~     70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to~     grow and are likely to respond to hormone treatment. This type of treatment reduces the~     amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One~     type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from~     making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is~     not being controlled by one class of AI are switched to the other class of AI. The reason~     for this is that some cancer cells can become resistant to one class but are still sensitive~     to the other class. However, oestrogen can be made in the body by two pathways and AIs block~     only one of these pathways. A new drug called Irosustat can reduce the production of~     oestrogen in the body by blocking the second pathway. This study is investigating whether~     adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further~     reduce the amount of oestrogen in the body and therefore control the breast cancer better.~      27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic~     breast cancer that is not being controlled by their current AI treatment will be recruited~     in this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of~     Irosustat once daily in addition to the AI on which they progressed. Patients will receive~     Irosustat for as long as it controls their cancer or until they have side effects that stop~     them from taking treatment. Patients will be seen monthly for the first 6 months and every 3~     months thereafter. Participating patients will also be given the option to take part in the~     exploratory part of this study by donating tissue and blood samples.~   "
97106|NCT01785979|"~     This randomized clinical trial will address a complication related to recurrent episodes of~     malaria in endemic areas - hyper-reactive malarial splenomegaly. We aim to assess the~     efficacy of chloroquine after prednisone-induction therapy compared to standard treatment of~     chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive~     malarial splenomegaly.~   "
97107|NCT01785966|"~     CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an~     intervention including 1) checklists with assessment of daily goals during the~     multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of~     patients admitted to intensive care units (ICUs).~      The investigators also aim to describe participant ICUs in terms of the standards for~     intensive care units proposed by the Brazilian National Health Agency (ANVISA).~   "
97108|NCT01785953|"~     The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years),~     treated with conventional and experimental chemotherapy following allogeneic~     transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of~     Hematology, Molinette University Hospital. The purpose of data collection is to assess, with~     retrospective analysis, the clinical outcome divided by risk class and evaluated in patients~     who achieve complete remission after induction therapy and consolidation.~   "
97109|NCT01785940|"~     Total shoulder surgeries are associated with considerable postoperative pain which may~     prevent rehabilitation and early discharge from the hospital. Continuous interscalene blocks~     with home infusions are commonly performed for pain relief following total shoulder~     arthroplasties. We want to evaluate the time to readiness for discharge following~     interscalene blocks in patients undergoing total shoulder arthroplasties.~   "
97110|NCT01785927|"~     The inhaled route of delivery has always been associated with the considerable challenge of~     getting the drug to its target. The lungs are a highly complex organ designed to filter~     inspired air, with many different cell types contributing to their function. Furthermore,~     the lungs may change dramatically when afflicted by disease resulting in an internal~     environment that works against the drug reaching and interacting successfully with the~     target. For targets in the upper airways this will have lesser significance, but drug~     delivery to the deep lung may be impeded by changes such as mucus hyper-secretion or~     thickening or airway narrowing.~      In order to interpret toxicology findings it is necessary to reconcile test sensitivity,~     background biological variation, normal responses to inhaled materials and drug or~     medicine-specific adverse effects. Identification of adverse end-points is an area where~     better control data sets might help discern true adverse effects from a normal physiological~     lung response. The lung responds acutely to inhalation of irritant materials by~     hyper-secretion of mucus, chemokine release, inflammatory cell recruitment and cough and~     collectively these may be characterized as non-specific irritancy.~   "
97122|NCT01785771|"~     An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients~     with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks~     followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued~     treatment with ITCA 650 60 mcg/day~   "
97123|NCT01785758|"~     The purpose of this study is to determine whether sugammadex reverses a profound~     neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just~     as effectively and safely as it does in patients with normal renal function.~   "
97111|NCT01785914|"~     This study provides for the collection of a series composed by patients with newly diagnosed~     of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with~     retrospective investigation, through the review of paper and electronic records and data~     cards in large part already collected as part of study protocols GIMEMA or BFM or NILG~     approved by the Ethics Committee of Hospital. The purpose of data collection is to check~     with retrospective predictability of classical risk factors in relation to disease response,~     and overall survival of the event-free survival, to estimate the cumulative incidence of~     competitive events such as the emergence of disease, acute and chronic transplant, the~     transplant-related mortality and relapse of disease.~   "
97112|NCT01785901|"~     This is a multi-centre, cross-sectional study planned to be conducted in China. The study~     aims to observe about 1500 asthma patients who have already received budesonide/formoterol~     combination treatment by physicians' determination and whose medications are aligned with~     the package insert of budesonide/formoterol approved in China.~   "
97113|NCT01785888|"~     This is a non-interventional diagnostic, international, multicenter and non-comparative~     study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic~     disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be~     conducted in Japan and Europe and will assess the concordance of EGFR mutation status~     derived from tumour samples and blood based circulating free DNA. The data generated will~     inform the use of less-invasive sample types in diagnostic practice. The study also aims to~     assess the current status of EGFR mutation testing across Japan and Europe and gaps in~     currently available data including EGFR mutation frequency in particular populations and~     demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR~     mutation test process and methodology, utility of multiple sample types in the assessment of~     EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be~     used to drive improvements to the EGFR mutation testing process, ensuring that patients have~     access to testing and are treated appropriately on the basis of the molecular features of~     their disease.~   "
97114|NCT01785875|"~     This study is designed to describe the long-term safety and efficacy of IV administration of~     AMG 416 for the treatment of SHPT in subjects with CKD on hemodialysis.~   "
97115|NCT01785862|"~     The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low~     dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from~     acute sore throat pain.~   "
97116|NCT01785849|"~     This study is designed to assess the efficacy and safety of AMG 416 compared with placebo in~     the treatment of SHPT in CKD subjects receiving hemodialysis as assessed by the change from~     baseline in serum iPTH, cCa x P and phosphorus.~   "
97117|NCT01785836|"~     This study will assess the safety, tolerability, and efficacy of dapsone in subjects with~     acne vulgaris following 12 weeks of treatment.~   "
97118|NCT01785823|"~     We investigated the efficacy and the safety of the pharmacokinetic model-based~     patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after~     total intravenous anesthesia (TIVA).~   "
97119|NCT01785810|"~     RATIONALE: Successful allogeneic stem-cell transplantation is often limited by~     graft-versus-host disease (GVHD). Migration of donor cells into tissues plays a major role~     in GVHD. Drugs that block chemokine receptors such as CCR5, can potentially decrease the~     migration of donor cells into tissues. Blocking CCR5 after allogeneic stem-cell~     transplantation may therefore reduce the rates of GVHD.~      PURPOSE: This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention~     of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced~     intensity conditioning.~   "
97120|NCT01785797|"~     This is a prospective randomised-controlled multi-centre trial based in Hong Kong to~     determine whether temporary subdural drain placement after burr hole evacuation of a chronic~     subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or~     above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole~     operative drainage will be randomly allocated into one of two groups: (1) for~     intra-operative subdural drain placement (intervention group) or (2) not for drain placement~     (control group). Using web-based software block randomisation with an allocation ratio of~     1:1 will be conducted. Instructions to use or not to use a drain will be contained in a~     sealed envelopes labelled with sequential study numbers.~      Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the~     haematoma the patient's condition is unsafe for drain placement, the subject will be~     excluded from the study. Otherwise, randomisation will be performed at this juncture by the~     opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain~     into the subdural space according to a standard protocol and will be removed on the second~     post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain~     placement is unsafe will be excluded from the study. Drainage is undertaken passively by~     hanging the collection bag at the bedside in a dependent position. In addition to general~     demographic, clinical and radiological presentation data, potential risk factors for~     recurrence will be documented. Serial computed tomography brain scans will be arranged~     (before discharge, at four weeks and six months) and the occurence of significant subdural~     haematoma recurrence requiring repeat operative drainage at six months will be recorded.~     Other outcome measures to be determined at regular time intervals for a total follow-up~     period of six months (upon discharge, at four weeks and six months) include: functional~     performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added~     neurological deficit, death and other surgery-related complications. All outcomes will be~     documented by the trial investigators or by the responsible clinician. The data obtained~     will be analysed according to the principle of intention to treat.~      Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control),~     the additional placement of a subdural drain after evacuation (intervention) will reduce the~     risk of recurrence requiring repeat surgery.~   "
97121|NCT01785784|"~     This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and~     safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for~     Topical Application (rhGM-CSF Gel) on deep 2nd burn.~      There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized,~     reference controlled study, all the subjects were randomized into two groups, test group~     (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were~     enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases~     were enrolled in reference control group. In the test group, after the patients were~     enrolled in the group, clean the wound surface regularly and wash with normal saline, spread~     the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the~     drug product every two or one day according to the effusion. In the reference control group,~     after the patients were enrolled in the group, clean the wound surface regularly and wash~     with normal saline, bandaging with iodophor gauze, change the drug product every two or one~     day according to the effusion. Whole treatment were lasted till the wound surface was~     healing completely, if it is not recovered in 4 weeks, calculate and record the healing~     rate. The secondary part of the study was a multicenter, open study, to investigate the~     safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this~     part of the study.~   "
97124|NCT01785745|"~     It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of~     neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in~     comparison with traditional therapeutic exercise. The traditional exercise protocol contains~     mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and~     exercises against elastic band resistance. The neurocognitive exercise protocol contains ten~     exercises involving specific instruments (e.g., table inclined with a board with five~     concentric circles, sponges of various texture). Each subject, randomly assigned to either~     neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2),~     will be submitted to one-hour session for three times a week for five weeks. The outcome~     measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome~     score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at~     baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3)~     from the end of treatment.~   "
97125|NCT01785732|"~     Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based~     renal denervation causes substantial and sustained blood- pressure reduction in patients~     with resistant hypertension.~      The purpose of RENSYMPIS is to study the effects of renal denervation on:~        1. Cardiovascular function~        2. Metabolic factors~        3. Inflammatory and endocrine factors~        4. Coagulation~        5. Sleep~   "
97126|NCT01785719|"~     The purpose of this study is to investigate the effects of weight loss on ovarian~     morphology, metabolism, and body composition in overweight and obese women with polycystic~     ovary syndrome (PCOS).~   "
97127|NCT01785706|"~     The COPD Research Registry is a confidential database of individuals diagnosed with COPD or~     at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with~     the purpose of providing a mechanism for researchers to boost enrollment in clinical trials~     and other research studies. The COPD Foundation is working with National Jewish Health in~     Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest~     confidentiality of participant information.~   "
97128|NCT01785693|"~     The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the~     benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and~     clonidine in a single dose, performed before induction of general anaesthesia, on analgesia~     postoperatively assessed by morphine consumption.~      Applied to the patient at the beginning of general anesthesia, this technique could allow~     one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb~     vasodilation - to improve tissue perfusion downstream.~   "
97129|NCT01785680|"~     The long-term objective of this proposal is to develop and demonstrate an effective,~     integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and~     non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.~      Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community~     coverage and a greater individual recovery rate than standard care.~   "
97130|NCT01785667|"~     The objective of this study is to clarify the current diabetic status, including development~     of complications, in a nationwide cohort of type 1 diabetics, who were last examined~     together in a large study in 1995. These youngsters were originally participating in a~     nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators~     will try to establish risk factors for developing diabetic retinopathy. The investigators~     will have emphasis on retinal vessel geometry and the possibilities for early detection of~     reversible retinal changes, and prediction of other vascular complications.~   "
97131|NCT01785654|"~     Prospective, observational clinical multicentric study in ICU; during the period surrounding~     the orotracheal intubation.~   "
97132|NCT01785641|"~     To compare the efficacy of single versus combined antibiotic therapy for bacterial~     peritonitis in CAPD patients.~   "
97133|NCT01785628|"~     The project will investigate the effect of pharmacological and electric modulation of~     N-methyl-D-aspartate (NMDA) pathway on the cognitive flexibility and volitional movement~     preparation in patients with Parkinson's disease (PD).~   "
97134|NCT01785615|"~     Little is known regarding the association of individual components of the metabolic syndrome~     (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional~     markers in women with this syndrome. Less is known about adequate treatment as the~     pathological mechanism of this syndrome is not well understood.~      The purpose of this study is two fold;~        1. To determine basic differences in biochemical and cardiovascular structural markers in~          women with and those without MBS and their association with the individual components~          of MBS.~        2. To determine the impact of atorvastatin to lower the risk factors of Metabolic~          Syndrome. Atorvastatin is one of the most effective drugs approved by the United States~          Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to~          a class of drugs called statins and its role in primary prevention is still unclear.~          Thus this population seems to be an ideal group that may benefit from this~          intervention.~   "
97135|NCT01785602|"~     The purpose of this study is to determine whether QAW039 is safe and has beneficial effects~     in people who have moderate to severe atopic dermatitis (AD).~   "
97136|NCT01785589|"~     The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear~     medicine. The increased photon counting sensitivity of camera can be used to explore novel~     protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with~     high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this~     imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image~     resolution and simultaneous assessment of viability, all with an exam duration of~     approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m~     sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary~     angiography. The investigators report here the first validation of high-speed protocol with~     dual isotope for myocardial perfusion imaging using invasive coronary angiography as the~     standard of reference.~   "
97137|NCT01785576|"~     The purpose of this study is to determine whether a brief couple-based supportive~     intervention effectively assists patients and their partners coping with the challenges of~     head and neck cancer.~   "
97138|NCT01785563|"~     The purpose of this study is to determine if a new type of mechanical ventilation, or~     breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide~     additional support to infants who were born prematurely. Investigators are looking to~     determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces,~     will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale)~     dissolved in their blood as compared to prior to starting the study. This will be~     accomplished by enrolling infants who are stable on their current type of mechanical~     breathing that provides a constant air flow into the infant. This type of mechanical support~     helps keep the lungs inflated but does not help remove carbon dioxide. This study will~     change the type of mechanical support to a type of support called neurally adjusted~     ventilatory assist or NAVA. This type of mechanical support detects when the infant is~     breathing in by having electrical sensors on a feeding tube that is placed into the stomach~     through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle~     that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the~     attempt to breath, it provides additional air flow to make the effort of breathing easier.~     The ventilator will be attached to a tube or cannula that is placed into the infant's nose.~     After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the~     blood will be performed by taking a small amount of blood from the infant's heel.~   "
97139|NCT01785550|"~     Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease~     affecting motor neurons. Early diagnosis is essential for the success of clinical trials and~     objective biomarkers are needed for monitoring disease progression. Nerve and muscle~     ultrasound may provide this information.~      This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to~     identify and monitor disease progression in ALS.~   "
97140|NCT01785537|"~     The main aim of this multicentric 5-year follow-up study is to evaluate for the first time~     the long-term efficacy and safety (in terms of smoking-related serious diseases requiring~     hospitalization) of e-cigarette smoking, comparing its health effects with those of~     traditional cigarette smoking and mixed electronic and traditional cigarette smoking.~      The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality~     of life, and the reported adverse events according to current and past smoking habit.~      Finally, the study will also explore the long-term adherence to e-cigarette smoking and its~     efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.~   "
97141|NCT01785524|"~     The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and~     peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption~     of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of~     supervised exercise training at the limb ischemic threshold (SET) will produce a greater~     clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT]~     relative to a group with the same exercise training but supplemented with placebo .This~     study is essentially exploratory in nature and designed to provide us with information to~     adequately develop power and execute a larger study. We have previously seen benefits from~     nitrate supplementation on function in PAD.~   "
97142|NCT01785511|"~     Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO~     also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory~     and repair mechanisms. NO may also be a mediator in the release of the endogenous~     fibrinolytic factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via~     these actions it plays a very important role in protection of the vasculature from~     atherothrombosis and clinical sequelae such as myocardial infarction and stroke.~      Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a~     phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores~     of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released~     upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and~     nitroso-species are increased after standing in a UVA phototherapy cabinet and that local~     UVA exposure is associated with increased forearm arterial blood flow that is independent of~     skin temperature. The investigators have also demonstrated a fall in mean arterial blood~     pressure in subjects exposed UVA.~      Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The~     investigators hypothesise that some of this geographical variation may be explained by a~     diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4~     To further examine the potential beneficial effects of UVA exposure we will examine the~     effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial~     flow reserve. The investigators will correlate these measures with systemic nitrate, nitrite~     and nitroso-species content in healthy volunteers.~      HYPOTHESES~        1. UVA irradiation enhances coronary flow reserve in healthy volunteers.~        2. UVA irradiation suppresses platelet activation in healthy volunteers.~        3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy~          volunteers.~   "
97143|NCT01785498|"~     Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource~     development project. The goal of the project is to develop an implementation plan that would~     enable children with complex heart problems to lead healthy, active lives within their own~     community. The primary goal of the project is to promote physical activity, because the~     physical and mental health benefits of activity are very important for these children.~     Children with complex heart problems have a higher risk for obesity, diabetes, acquired~     heart disease and mental health problems than their healthy peers. The physical health~     benefits of physical activity are well known, but physical activity is also key for~     children's mental health. Physical activity enables children to socialize with peers and~     create bonds and friendships. Physical activity participation also directly elevates mood~     through the release of brain chemicals. Children with complex heart problems are also known~     to experience fear and anxiety related to physical activity. This project will also develop~     strategies to promote healthy eating and the prevention of physical activity-related~     injuries to these children and their families. Children with complex heart problems are at~     higher risk of overweight and obesity and face unique injury risks related to pacemakers or~     their medications.~      Extensive consultations with families and caregivers have identified needed supports for~     physical activity lifestyles, mental health, healthy eating and injury prevention for these~     children. The goal of the interviews was to understand the positive and negative influences~     on physical activity and healthy lifestyles for these children. Analyses of the interview~     content was used to develop a detailed, step-by-step implementation plan to provide the~     supports necessary for children with complex heart problems to lead active, healthy lives in~     their own community, with their family and friends. The implementation plan specifies~     changes to family education and counselling resources, clinical care routines, and~     communication among professionals and families.~      The clinical trial will evaluate the impact of implementing the family supports and changes~     to practice previously developed. Surveys will be completed by families attending the~     cardiac clinic before and after the changes to practice and additional resources are made~     available. Interviews will be utilized to gather additional feedback from professionals and~     families that receive counselling utilizing the supplementary materials.~   "
97155|NCT01785342|"~     The goal is to improve the efficiency of the diagnostic follow-up of patients with~     indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis~     that are measured in minimally invasive biospecimens are able to distinguish malignant from~     benign pulmonary nodules that are incidentally detected in high-risk smokers.~   "
97156|NCT01785329|"~     Primary Objective:~      To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553~     (REGN727) administered at 3 different injection sites in healthy subjects.~      Secondary Objectives:~        -  To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab~          SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and~          apolipoproteins.~        -  To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).~        -  To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553~          (REGN727).~   "
97144|NCT01785485|"~     This study is Phase II of a project by the University of Arizona Center for Integrative~     Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics~     (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the~     clinical and cost effectiveness (outcomes) of an integrative medicine professional practice~     model for adult primary care delivery (the University of Arizona Integrative Health Center -~     UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC.~     In addition, a fidelity evaluation will assess whether the practice model was implemented as~     planned.~      The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and~     staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient~     data from medical records abstractions, self-report assessments, clinic administrative and~     service utilization/encounter data, and health insurance claims data; and, 3) Conduct~     fidelity evaluation of the implementation of the UAIHC model as described in its business~     plan using patient- and staff-reported fidelity assessments, random chart audits, and~     abstracted clinic administrative data.~      Participants. 1) Participants from the clinic patient population for whom clinical and cost~     outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be~     collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected~     (n=14).~      Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic~     visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and~     biomarkers from medical records abstractions; patient reported outcomes and satisfaction~     questionnaires; clinic service encounter logs; and, cost data from health insurance claims~     information and clinic financial data. For fidelity evaluation, data will be collected~     monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually~     from then on. Patient data for fidelity will be gathered on a single randomized day of the~     week using a self-administered patient feedback questionnaire. For personnel, fidelity data~     will be collected at the same intervals using a self-administered provider perceptions~     questionnaire of inter-professional team and integrative medical care. Data from audits of~     randomly selected patient charts and administrative records will also be used.~   "
97145|NCT01785472|"~     This study will assess the efficacy and safety of multiple doses of LCZ696 compared to~     olmesartan in Asian patients with essential hypertension~   "
97146|NCT01785459|"~     Headache is a common chief complaint of patients presenting to the emergency department~     (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often~     a source of frustration for both patients and providers. By the time patients with benign~     headaches arrive in the emergency department, they have often failed non-invasive~     therapeutic attempts and providers are often left with few therapeutic options. Treatment of~     benign headache varies between providers, often including systemic medications with a~     multitude of possible side effects. In recent years, there has been preliminary~     investigation into anesthetic injections for the undifferentiated headache patient~     presenting to the emergency department. It has been proposed that these patients presenting~     with benign headache might benefit from this novel treatment.~      Patients that present to the Emergency Department with a diagnosis of benign or primary~     headache with serious or life-threatening causes of headache will be offered enrollment into~     the study.~      Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the~     paraspinal musculature of the cervical spine or the standard treatment with intravenous~     Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes~     after injection. At twenty minutes post-injection, the subject will be reevaluated for~     symptoms. The subject will then be eligible for discharge or standard treatment at the~     discretion of the treating physician.~      Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects~     will be monitored for immediate and post-discharge complications.~   "
97147|NCT01785446|"~     The purpose of this study is to:~        -  determine the effect of dexmedetomidine on cisatracurium infusion requirements and~          sufentanil consumption.~        -  analyze the cisatracurium infusion requirements and sufentanil consumption in different~          age groups.~   "
97148|NCT01785433|"~     The primary objective of this study is to assess and compare the pharmacokinetics (PK) of~     Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day),~     SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day)~     following repeat dosing for 7 days in subjects with COPD.~   "
97149|NCT01785420|"~     Background Information and Rationale:~      Trastuzumab is a humanized monoclonal antibody that acts extracellularly on the erbB-2~     receptor.Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the human~     epidermal growth factor receptor 2 (HER2/erbB-2),which has shown in both in vitro assays and~     in animals, to inhibit the proliferation of human tumour cells that overexpress erbB-2.~     Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated~     cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially~     exerted on erbB-2 overexpressing cancer cells compared with cancer cells that do not~     overexpress erbB-2. Trastuzumab has emerged as a widely accepted standard of care for~     erbB-2-positive disease. (Metastatic/ adjuvant/neoadjuvant.~      Our current hypothesis suggests that the cells which are disseminated at the time of surgery~     will encounter an inhospitable environment which will be anti-HER in nature. Therefore~     combining the above mentioned streams of thought, we would like to assess the effect of a~     short pre-operative course of Trastuzumab on breast cancer relapse. The study is proposed in~     HER2 positive patients with operable breast cancer.~      Objectives :~      Primary:~      The primary objective of the study is to see the effect of short duration of peri-operative~     Trastuzumab on disease-free survival in comparison in all patients~      Secondary:~      The safety of the pre-operative therapies including the early post operative morbidity~        1. Overall survival (OS) in all patients and in pathologically node positive patients.~        2. The level of circulating tumor cells (CTCs) in the peripheral blood assessed before~          starting pre-operative therapy and at the same time point in the control arm, level of~          CTCs 10 minutes prior to start of surgery, during surgery and 10 days after surgery on~          40 consecutive consenting patients (20 in each arm). The levels of circulating~          chromatin will also be estimated at the same time points as CTC for these 40 patients.~        3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2~          on 100 consecutive consenting patients (50 in each arm).9-11~      Study Design :~      This is phase 3, randomized Double blinded parallel group study of Trastuzumab in pre~     operative setting in operable breast cancer patients.~      Approximately 1000 patients with Women with HER2neu positive, T1/T2/T3 and N0/N1. clinical~     T4 and/or N2 disease who are considered operable by the treating surgeon with~     histopathological diagnosis on core biopsies, will be included in the study. Patients with~     T4 or N2 (locally advanced and large operable for neo-adjuvant chemotherapy) will not be~     included. All node positive patients will receive single injection of Depot Inj.~     Progesterone 500 mg deep IM 4 -14 days prior to surgery~      Patients will be stratified, before randomization for Tumor size, menopausal status, and~     affordability for Trastuzumab and centre of the study. These patients will then be~     randomized 1:1 to receive the following~      Intervention arm: .A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as~     a 90 minute intravenous infusion in 250 ml of normal saline, in the window period of 10-15 4~     to 14 days (both days inclusive) prior to the planned date of surgery.~      Control arm: A 90 minute intravenous infusion of saline as placebo~      All patients will thereafter receive standard post-operative adjuvant therapy as per local~     institutional practice including hormonal therapy, chemotherapy and radiation therapy.~   "
97150|NCT01785407|"~     Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia.~     However, absorption of OIS is often low and response is variable. To overcome this, large~     doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses~     should be low, while maximizing absorption. The prevailing serum hepcidin concentration~     (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based~     on limited data in humans, SHep can be increased by a single OIS dose but the duration of~     the increase is uncertain: it may be in the range of 24 to 96 hr. Also, there are few data~     on how the increase in SHep determines the absorption of further doses of oral iron. Is~     there a threshold SHep at which subsequent iron absorption is sharply reduced? Better~     understanding of this relationship would be valuable to design more effective and safer OIS~     regimens.~      Objectives: 1) Determine the duration and magnitude of the Fe induced Hepcidin rise form a~     single iron dose while determining its bioavailability and 2) Compare the bioavailability of~     a single dose to iron supplements consumed one after the other (two dosages).~   "
97151|NCT01785394|"~     The purpose of this study is to determine whether exhaled breath temperature, a surrogate~     marker of airway inflammation, rises during the pollen season in sensitized subjects with~     allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with~     respective allergens suppresses the seasonal increase of EBT. During the second year (2013)~     of the trial all patients will be treated with 5 grass allergen extract: carry over~     differences between the active and placebo arms from the previous year (2012) will be looked~     for.~   "
97152|NCT01785381|"~     Introduction: Hip fracture due to osteoporosis is associated with an extremely high~     mortality morbidity and loss of quality of life. The risk of future fracture after a first~     hip fracture is increased. Several studies reported that patients who suffered from a~     fracture are not optimally treated and do not receive osteoporosis treatment after the first~     fracture episode.~      Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic~     fracture patients and hip fracture patients.~   "
97153|NCT01785368|"~     The main objective of this study is to evaluate the impact of the implementation of referral~     guidelines for imaging exams requested by the emergency department on exam relevance. The~     latter is assessed via the rate of suspected diagnoses that are confirmed by the requested~     exam.~   "
97154|NCT01785355|"~     Several studies revealed a direct relationship between the severity of periodontal~     inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other~     source of inflammation but PDD, proper dental treatment of the disease decreased CRP to~     normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007)~     Moreover, a direct link between high levels of CRP and atherosclerotic complications has~     been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig~     W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999;~     Zimmermann J, et al. 1998).~   "
97158|NCT01785303|"~     The overall goal of this project is to determine the efficacy of a multidisciplinary~     treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.~      Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive~     Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with~     OSA and comorbid insomnia.~      Specific Aim 2: To determine if there are relative benefits in the sequence of treatment~     initiation.~      Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.~   "
97159|NCT01785290|"~     The aim of this study is to determine the effects of a low dosage of prophylactic~     haloperidol in patients with a high risk to develop delirium, defined by an expected ICU~     length of stay of >1 day. The investigators hypothesized that haloperidol prophylaxis in~     patients with a high risk for delirium reduces 28-day mortality, delirium and delirium~     related outcome.~      Two different dosages of haloperidol are used in this study to compare with placebo. A~     dosage of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in~     a three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the~     potential beneficial effects of haloperidol to the a priori risk to develop delirium, the~     PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable~     the investigators to determine the preventive efficacy of haloperidol in patient groups~     based on their risk to develop delirium.~   "
97160|NCT01785277|"~     The propose of the study is to validate in Mexico a spanish translation of the Spinal Cord~     Independence Measure (SCIM) Version III, in patients with spinal cord injury (SCI).~      Internal consistency, reproducibility and reliability will be addressed scoring the results~     of the translated version at two time frames and also of the same patients by different~     examiners (physicians, nurses and technicians).~   "
97161|NCT01785264|"~     To compare the end-results of three different methods of treatment of acute achilles tendon~     ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally,~     early mobilization has been reserved for patients treated surgically and this may have~     unintentionally skewed treatment results. The investigators have therefore designed a~     prospective randomized trial performed as collaboration between Akershus University Hospital~     (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad)~     and Drammen Hospital. The four institutions were chosen because of their geographical~     proximity and because they jointly have a substantial catchment area. Treatment is divided~     into three arms, and patients between 18 and 60 years of age sustaining first time achilles~     tendon ruptures will be invited to participate.~   "
97162|NCT01785251|"~     Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein~     Thrombosis (DVT) during the recovery period following surgery despite the availability of~     effective pharmacological and mechanical prophylactic methods. The use of calf muscle~     neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this~     patient group may be effective at preventing DVT. However, the haemodynamic effectiveness~     and comfort characteristics of NMES in post-THA patients immediately following surgery have~     yet to be established.~      The main objectives are:~        1. To establish if patients in the early post-operative period have tolerance for NMES.~        2. To determine if applying NMES to patients immediately post-THA increases venous outflow~          from the lower limb over resting conditions.~   "
97163|NCT01785238|"~     The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who~     have presented neonatal acute renal failure. The investigators hypothesize that signs of~     nephronic reduction would appear earlier in former preterm with neonatal acute renal failure~     than in control preterm infants.~   "
97164|NCT01785225|"~     Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are~     performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement~     or blood donation. The predominantly used venous for blood withdraw are in the cubital~     region because in this area venous are most superficial placed and most often visible for~     the human eye. However, when using the usual blind landmark and palpation method in this~     region, it often proves exceedingly difficult or even impossible to obtain peripheral venous~     access on patients who are obese, chronically ill, hypovolemic or intravenous drug users.~     Various studies have shown that the success rate for establishing a vascular access with~     ultrasound compared to blind landmark technique is higher in patients with difficult access.~     When ultrasound is used to establish intravascular access, the prerequisite sterile puncture~     area can be challenging to meet due to ultrasound gel on the area and the fact that the~     ultrasound transducer cannot be wiped clean with alcohol after being in contact with a~     patient's skin or blood. A strict sterile procedure is important to reduce complications~     related to infection.The traditional way of coping with this is by covering the transducer~     and the wire in a long sterile sheet and using sterile gel. The sheet must be tight with~     rubber band around the transducer and pulled tightly around the transducer foot to prevent~     artefacts from appearing on the screen. This is an expensive and time consuming method, and~     it still leaves the problem with gel in the puncture area.~      The investigators have developed a method by where all these problems are solved by using, a~     slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning~     technique~      The investigators hypothesize that it is possible to perform ultrasound-guided venous~     puncture with a sterile and dry puncture area and that puncture can be performed proximal~     and distal to the traditional puncture side.~      It is a procedure presenting study that serves to demonstrate the feasibility of the method~     in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.~   "
97165|NCT01785212|"~     The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic~     resection in our center. Recently a stapler-hepatectomy methods has been developed and~     approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this~     method is a potential shorter transection time compared to the CUSA technique. Thus the~     investigators will perform a randomized controlled trial including 20 patients in the~     stapler-group and 20 patients in the CUSA control group. Primary endpoint will be~     transection speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines~     concentration, T cell subsets, blood loss, morbidity, and a cost analysis.~   "
97166|NCT01785199|"~     Sleep is known to be a dynamic state of consciousness that is characterized by rapid~     fluctuations in autonomic activity as well as changes in body postures. Body postures during~     sleep influence the severity of sleep-disordered breathing because a supine position is~     associated with an increase in upper airway collapsibility and thus an increase in frequency~     and duration of snoring and apnea. Use of an adjustable bed to elevate patients' head might~     improve those conditions. The purpose of the present study is to determine whether use of an~     automatic adjustable bed is associated with reducing sleep-disordered breathing in patients~     with suspected obstructive sleep apnea (OSA) due to upper airway problems.~   "
97258|NCT01783990|"~     The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea~     (also called HU) in children with sickle cell disease could prevent organ damage, especially~     in the spleen and kidneys. There was also a chance that treatment could prevent painful~     crises, lung disease, stroke, and blood infection.~   "
97167|NCT01785186|"~     This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized,~     controlled clinical trial that will compare the efficacy and safety of four experimental~     four drug regimens with a standard control regimen in patients with smear positive,~     pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of~     the four experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given~     for 12 weeks. Thereafter, participants in the experimental arms will receive continuation~     phase treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All~     participants will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent~     INH‐related neuropathy. Interim analyses will be conducted during the trial for efficacy,~     with the aim of identifying experimental arms that perform below a pre‐specified efficacy~     threshold; these arms will then be stopped from further recruitment.~      Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee~     (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has~     stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on~     these arms not meeting the pre-specified gain in efficacy over control. Importantly, there~     was no safety concern that prompted stopping recruitment to these arms. They recommended~     that recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient~     evidence that these regimens could shorten treatment. Importantly, there was no evidence~     that either arm was inferior to standard treatment (the control arm) with regards to~     efficacy. There was, however, sufficient evidence that the other intervention arms HR35ZE~     and HR20ZM could shorten treatment to continue enrolling patients.~   "
97168|NCT01785173|"~     Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is~     one of the most frequently performed diagnostic procedures in Japan and Europe. The~     technique of using a cotton pledget soaked with lignocaine and decongestant is quite~     effective but does cause some discomfort during application of anesthetic agent to the nasal~     cavity. Hence, an effective method to deliver anesthetic agent, using a minimal dose of~     drugs, and at the same time maintain a good ﬁeld of vision during endoscopy are all very~     important.~      Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it~     around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance~     to deliver a gauze strip can confirm delivering it to at least the posterior end of a~     turbinate. We hypothesize that a simple endoscopic-guided gauze pledgetting method is more~     tolerable than the blind cotton-tippled applicator method to deliver a gauze strip for~     anesthetizing the nasal cavity.~   "
97169|NCT01785160|"~     The primary objective of this trial is to investigate effect of faldaprevir on steady state~     pharmacokinetics of raltegravir.~      The assessment of safety and tolerability will be an additional objective of this trial.~   "
97170|NCT01785147|"~     Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy~     and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by~     subject diary and confirmed by exhaled CO (abstinent < 10 ppm).~   "
97171|NCT01785134|"~     Obese patients have an increased risk for developing severe metabolic disorders. This risk~     can only partly be reduced by weight reduction. The investigators have in a pilot study~     investigated if removal of abdominal fat (visceral) in addition to weight loss has~     additional beneficial effects on the metabolic profile and weight loss. This study aims to~     further investigate if removal of abdominal fat (major omentum) leads to beneficial~     metabolic effects.~   "
97172|NCT01785121|"~     The study objectives are to determine the effectiveness of structured access to a Wii game~     computer compared to motivational support only in heart failure patients on exercise~     capacity and daily activity. Secondly, to determine the effectiveness of structured access~     to a Wii game computer compared to motivational support only in heart failure patients on~     the combined endpoint of death, readmission and quality of life.~      The following research questions will be addressed:~        -  What is the effectiveness of structured introduction and access to a Wii game computer~          in patients with heart failure to improve their exercise capacity compared to patients~          with heart failure in a control group who only receive motivational support?~        -  What is the effectiveness of structured introduction and access to a Wii game computer~          in patients with heart failure compared to patients with heart failure in a control~          group who only receive motivational support to increase their daily physical activity,~          decrease health care use and improve quality of life?~        -  What are experiences of heart failure patients and how is their exercise motivation~          when they are introduced and instructed to play with a Wii game computer?~   "
97173|NCT01785108|"~     The objectives of this study is to~        -  evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with~          Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently~          diagnosed Type 1 Diabetes~        -  evaluate how the above mentioned treatments influence the immune system of the subjects~          and interact with any viral infections~        -  evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd)~          plus Vitamin D on the immune system, viral infections, and on preservation of residual~          insulin secretion in recently diagnosed Type 1 Diabetes~   "
97174|NCT01785095|"~     The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy~     volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation~     program.~   "
97175|NCT01785082|"~     The purpose of this study is to investigate safety and efficacy of intravenously injected~     0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on~     patients with partial liver resection. The LiMAx-test is compared with an untreated control~     group and post-surgical management of both groups is investigated.~   "
97176|NCT01784250|"~     The aim of the study is to determine the efficacy of clonidine and propranolol for transient~     anxiety management and intra and postoperative pain in patients undergoing ambulatory~     surgery of third molar.~   "
97259|NCT01783977|"~     NOTE: This study has stopped enrolling new participants, and all study vaccinations for~     currently enrolled participants have been stopped.~      Currently, there are no vaccines approved for the prevention of HIV infection, but there are~     many clinical trials taking place that are studying experimental HIV vaccines. The purpose~     of this study is to evaluate the safety and tolerability of three different HIV vaccine~     schedules in healthy, HIV-uninfected adults.~   "
97260|NCT01783964|"~     This study is performed to measure the quantity of i.v. applied elacytarabine that leave the~     body, by which route and how fast.~   "
97177|NCT01784237|"~     A sniff test for nasal patency is a common method before ultrathin transnasal~     esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet~     there is no objective method to select an appropriate meatus insertion site (MIS) where~     tolerance and epistaxis rate can be improved.~      The investigators hypothesize that that an objective anterior rhinoscopy (to be more~     specific, the investigators term it anterior meatoscopy) method might be more effective~     than the subjective breathing-in method (sniff test) to select the appropriate meatus~     insertion site, thus reducing nasal bleeding and nasal discomfort.~      The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale~     (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events~     during nasal anesthesia and UT-EGD.~      The investigators will perform a prospective randomized-controlled trial to compare patient~     tolerability and adverse events during nasal anesthesia and endoscopy between the~     AM-selected and self-selected MIS. A total of 233 consecutive patients with epigastric~     discomfort (symptoms of non-ulcer dyspepsia) will be included in the study in a large~     tertiary referral hospital in Taiwan.~   "
97178|NCT01784224|"~     The main purpose of this study is to investigate voice production, speech intelligibility~     and routine physiologic parameters associated with the Blom low profile voice inner cannula~     and the Passy-Muir one-way tracheotomy tube speaking valves.~      Additionally, the purpose of this study is to investigate the effects (if any) associated~     with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube~     speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal~     complex during routine diagnostic modified barium swallowing evaluations.~   "
97179|NCT01784211|"~     The purpose of this study is to measure how much of the study drug or insulin glargine gets~     into the blood stream and how long it takes the body to get rid of it. The effect of~     exercise will also be evaluated.~      This study has two parts. In Part A, each participant will receive a daily injection of~     LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B.~     In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with~     or without exercise. Part B lasts about 6 days.~      Participants will remain on their regular physician-prescribed meal time insulin throughout~     the study.~   "
97180|NCT01784198|"~     Protein is an essential part of our diet. It is used to build muscle and body tissue, send~     signals throughout our body and to support the immune system. Dietary protein is even more~     crucial during pregnancy as it is needed for healthy growth and development of the baby.~     There is very minimal data available on how much additional protein is required during~     pregnancy. Current recommendations are based on older techniques such as nitrogen balance~     studies of non-pregnant adults and minimally based on pregnancy specific data. There is no~     scientific information regarding the amount of protein needed during different stages of~     pregnancy.~      The investigators hypothesize that the current recommendations of protein intake during~     pregnancy are underestimated.~      The goal of this study is to measure protein requirement in healthy pregnant women~     (19-35y)using a more quick and modern technique called the indicator amino acid oxidation~     technique (IAAO).~   "
97181|NCT01784185|"~     The study has been designed to evaluate the clinical application of the new virtual~     bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or~     enlarged lymph nodes. The software uses data from thorax CT scan and enables airway~     segmentation and reconstruction simultaneously with predefined mediastinal targets. The most~     suitable sites for transbronchial needle aspiration are displayed on the internal surface of~     the airways showed in VB mode.~      The diagnostic yield of the new system-assisted TBNA will be compared to the reference~     method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node~     enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods.~     Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA~     of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic~     material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to~     the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained~     with the two methods will be assessed and compared.~   "
97182|NCT01784172|"~     The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA）~     for simple female stress urinary incontinence.~   "
97183|NCT01785056|"~     The purpose of this research is to study the effects of Privigen (intravenous~     immunoglobulin) on the skin in patients with scleroderma. Approximately 24 subjects will~     take part in this investigator-initiated study at Georgetown University Hospital and Johns~     Hopkins Hospital. This study will last for one year (12 months). This research is being done~     because systemic sclerosis can cause severe, progressive organ involvement. The~     investigators hope this study treatment will improve the outcomes in this disease, including~     skin, muscle, joint, gastrointestinal, and lung involvement.~   "
97184|NCT01785043|"~     Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized,~     open-label, parallel-group and active controlled trial~   "
97185|NCT01785030|"~     Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during~     painful medical procedures. However, one of its effects is to also make veins appear larger~     and more visible. This is useful when there is a patient who needs to have an intravenous~     (IV) needle put in their skin to give them medicine or ﬂuids, but may have veins that are~     very hard to see or feel. The mechanism of this observed effect is not entirely clear. The~     purpose of this study is to use an ultrasound to directly measure whether there is an actual~     change size of veins or change in blood flow in healthy adult volunteers when you give them~     50% nitrous oxide, and see whether or not this change in size, or change in flow, is what~     causes the changes in visibility or palpability of the vein.~   "
97186|NCT01785017|"~     A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and~     implemented at Boston Children Hospital to decrease variations in clinical practice in~     critical asthma therapies for children. The primary aim is to determine whether a Critical~     Asthma SCAMP can improve clinical outcome.~   "
97261|NCT01783951|"~     The purpose of this study is to evaluate the antitumor effect and safety of clinical~     effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK)~     for advanced gastric cancer.~   "
97262|NCT01783938|"~     The purpose of this study is to evaluate the safety and efficacy of a sequential combination~     therapy of Nivolumab and Ipilimumab~   "
97187|NCT01785004|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (1 gram of omega-3 fatty acids) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study (VITAL Adiposity) is being conducted among~     participants in VITAL and will examine the effect of vitamin D or fish oil on changes in~     body composition and adiposity (baseline compared to 2 year, as measured by anthropometric~     indices, total and regional body fat and adipokines) and assess whether changes in~     cardiovascular risk factors (lipids, glucose tolerance, blood pressure) are mediated by~     these parameters. How achieved 25(OH)D levels are affected by body composition and body mass~     will also be assessed.~   "
97188|NCT01784991|"~     This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management~     protocol for the treatment of moderate to sever pain in the Emergency Department.~     Appropriate patients 60 years and older who present with a condition that causes moderate to~     severe pain, according to the attending physician's judgment, in which the physician would~     order the use of parenteral analgesia will be enrolled in one of two study arms, 1+1~     versus usual care group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg~     after 15 minutes if pain persists. Usual care group patients will have pain treated per the~     discretion of the attending physician. Respiratory status, vital signs, and pain scores will~     be monitor to assess the efficiency of pain control as well as the safety of pain medicine~     administration in terms of respiratory depression.~   "
97189|NCT01784978|"~     The objective of this study is to assess the progression-free survival, of patients who~     receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a~     first line treatment followed by everolimus when progression occurs.~   "
97190|NCT01784965|"~     The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a~     long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead~     to greater weight loss than will a calorie-restricted diet alone in subjects who are older~     (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been~     selected for study because they are at greatly increased risk to develop type 2 diabetes~     (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of~     liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse~     outcomes.~      There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic~     control in patients with manifest 2DM. However, there is relatively little information as to~     the potential utility of these compounds in nondiabetic individual at greatly increased risk~     of 2DM and CVD. This research proposal is aimed at providing some of this information by~     quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss,~     insulin secretion, insulin action, and multiple CVD risk factors in a very high risk~     group—older, overweight/obese, prediabetic individuals. Furthermore, by using specific~     methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it~     will be possible to gain new insights into the effects of GLP-1 on insulin secretion and~     insulin action.~   "
97191|NCT01784952|"~     We examined whether a substitution of whole grains and legumes for refined rice in a high~     carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of~     this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.~   "
97192|NCT01784939|"~     HFE(High iron FE)-related hereditary hemochromatosis has a highly variable penetrance. No~     phenotypic or genetic markers can predict the disease. The Iron Reabsorption Index (IRI),~     recently described by our group, correspond to the daily reabsorbed iron for a subject whose~     iron stock is stable and less than 50 µg / L.~      The IRI is constant over time, reflecting the importance of the underlying functional~     deficit.~      Hepcidin / ferritin (H / F) ratio may be an independent and constant over time marker of~     disease stage.No data are available on the validated values of this ratio.~      The goal of this project is to determine the intra-individual variations of the H / F ratio~     over time during maintenance therapy and to assess the correlation with the IRI.~   "
97193|NCT01784926|"~     In this prospective, randomized study The investigators will include 80 patients with late~     intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To~     obtain normal visual function, these patients needs surgery. Today, there are two different~     methods used for this condition; scleral suturing of the capsular complex or exchange of IOL~     to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages~     and dis-advantages for these two methods.~   "
97194|NCT01784913|"~     In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a~     therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability~     of UV1 as well as immunological response will be assessed. The purpose of this study is to~     select a biological dose of peptides for further clinical trials.~      Main treatment period is completed. Follow-up ongoing.~   "
97195|NCT01784900|"~     Treatment by association of complete surgical excision of the lesions and intraperitoneal~     immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis~   "
97196|NCT01784887|"~     Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment,~     quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in~     wound healing will be observed on a cellular, histomorphological and clinical level in the~     presence of a bioelectric dressing applied in conjunction with SOC.~   "
97212|NCT01784679|"~     HIBM is a severe progressive myopathy that typically presents in early adulthood as weakness~     in the distal muscles of the lower extremities and progresses proximally, leading to a loss~     of muscle strength and function, and ultimately a wheelchair-bound state. The rate of~     progression is gradual and variable over the course of 10-20 years or longer. There is a~     need to better understand the disease-specific features of HIBM to heighten disease~     awareness; facilitate early diagnosis; identify patients; expand knowledge of the clinical~     presentation, progression and variation of the disease; identify and validate biomarkers and~     other efficacy measures; inform on the design and interpretation of clinical studies of~     investigational products; and eventually to optimize patient management.~   "
97263|NCT01783925|"~     The objective of this PMS is to gain information about safety and efficacy in real practice~     as a regulatory commitment required by MFDS~   "
97197|NCT01784874|"~     The aim of this study is to generate data on immunogenicity and safety of Purified Vero~     Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the~     registration of VRVg in the USA.~      Primary Objectives:~        -  To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of~          subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at~          Day 42.~        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5~          IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.~      Secondary Objectives:~        -  To assess the clinical safety of VRVg each vaccine after each vaccine injection when~          administered in a pre-exposure schedule.~        -  To describe the immune response induced by each vaccine 21 days after two vaccinations~          (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of~          the primary vaccination series.~        -  To describe antibody persistence at 6 and 12 months after the first vaccination in all~          subjects, and at 18 and 24 months in a subset of subjects.~   "
97198|NCT01784861|"~     This study is to evaluate the combination of an investigational drug X-82 with everolimus in~     the treatment of pancreatic neuroendocrine tumors.~   "
97199|NCT01784848|"~     Phase 3, unicentric, randomized clinical trial, with allocation concealment and~     intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y~     Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal~     levels of blood pressure, decrease systemic arterial blood pressure and other risk factors~     for cardiovascular events compared to clinical treatments of patients with arterial~     hypertension.~   "
97200|NCT01784835|"~     The application of osteopathic manipulative treatment (OMT) in preterm infants has been~     demonstrated to be effective in reducing length of stay (LOS). The scope of the present~     study is to investigate the association between earlier exposure to OMT and reduction of LOS~     in premature infants~   "
97201|NCT01784822|"~     The Hybrid Graft study is a post-market observational study to collect data on the~     performance of the Hybrid Graft when used to reinforce or bridge the abdominal wall for the~     repair of ventral hernias.~   "
97202|NCT01784809|"~     The proposed study addresses a significant public health threat of Human immunodeficiency~     virus (HIV) and sexually transmitted infections (STIs) among drug involved women on~     probation, parole or other community supervision. This randomized controlled trial aims to~     test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug~     use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in~     increasing condom use and decreasing the incidence of sexually transmitted infections (STIs)~     among 420 drug-involved, female offenders in a large community court setting in New York~     City, compared to a non-media version of the same intervention (Traditional WORTH) and to a~     4-session Wellness Promotion condition.~   "
97203|NCT01784796|"~     The purpose of this study is to determine how a stress reduction program, called Mindfulness~     Based Stress Reduction (MBSR), compared to a health education program, improves well being~     and reduces the risk of heart disease in women Veterans.~   "
97204|NCT01784783|"~     The purpose of this study is to investigate the impacts of home-based couple HIV-testing and~     counseling and male partner education on partner HIV testing and other critical maternal and~     infant health outcomes during pregnancy and the postpartum period. Additionally, the study~     seeks to assess the cost-effectiveness of this approach.~      Involvement of men during the antenatal and postpartum period, including HIV testing of male~     partners, can have substantial benefits for women and infants. In observational studies,~     male participation in antenatal care has been associated with increased uptake of prevention~     of mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya~     found a significant HIV-free survival benefit for children of HIV-infected women whose male~     partners attended antenatal care where couple HIV testing was offered. In this study only~     31% of ~450 men invited for counseling and testing came to clinic, highlighting the~     challenges faced across sub-Saharan Africa when trying to access male partners of pregnant~     women.~      In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable~     because home-based counseling and testing is highly acceptable and the benefits of male~     participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and~     infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical~     transmission among these women, but efforts to engage men in antenatal care in Western Kenya~     have thus far achieved limited success. This intervention may achieve gains beyond~     prevention of maternal and infant HIV-1 acquisition through identification of HIV-infected~     men who would otherwise not learn their status or delay treatment, and by improving child~     health through targeted education of male partners. When administered in a home-based~     setting simple, established interventions such as the promotion of exclusive breastfeeding~     have been shown to be associated with significant reductions in child mortality. Home-based~     approaches also lend themselves to integration with targeted interventions such as promotion~     of HIV testing among male partners of at-risk pregnant women. Furthermore, a successful HIV~     testing program for male partners of pregnant women has potential to reach a large number of~     men who may be unaware of their HIV status or who are HIV-infected but not in care,~     providing linkages to treatment clinics and promoting prevention interventions, such as safe~     sex and voluntary male circumcision for those who are uninfected.~      In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be~     randomized to standard antenatal care or home-based partner education and HIV testing (HOPE)~     as part of routine pregnancy services. Women will be enrolled at the antenatal clinic in~     Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE~     Intervention, featuring home-based couple counseling and HIV testing as well as key~     educational messages concerning HIV prevention behaviors, facility delivery, exclusive~     breastfeeding, and post-partum family planning. Women in the control arm will be invited to~     bring their male partners to the antenatal clinic for voluntary clinic testing and~     counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and~     again with their male partner 6-months post-partum. These follow-up visits will include~     questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding~     and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the~     intervention will also be evaluated in order to inform future scale-up.~      First, the investigators hypothesize that successful implementation of HOPE will result in~     higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The~     investigators also hypothesize that there will be benefits to HIV-infected and~     HIV-uninfected women and their children who will have improved uptake of interventions to~     improve maternal and child health. Specifically, the investigators anticipate higher levels~     of facility delivery, optimal breastfeeding practices, and post-partum contraceptive use, as~     well as increased uptake of antiretroviral treatment for HIV+ women in the intervention arm,~     relative to the control arm. Second, the investigators hypothesize that greater than 85% of~     HIV-1-infected men identified through home-based partner education and testing (HOPE) will~     access care and treatment services, and, overall, more women in the HOPE arm will know their~     partners' status at each time point and more partners will be in care and treatment. Third,~     the investigators predict that uptake of counseling and testing and HIV prevalence among~     male partners and family members will be high enough to make this approach cost-effective~     from both payer and societal perspectives.~   "
97205|NCT01784770|"~     To collect retrospectively the efficacy and safety information of azithromycin IV on~     patients with Legionnaires' disease related to their appropriate use in daily practice.~   "
97206|NCT01784757|"~     A study to investigate which of two different tablet formulations of ODM-201 is best suited~     for use in the further development of the compound in the treatment of metastatic~     chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing~     the bioavailability study will be able to receive further treatment with the current capsule~     formulation of ODM-201 until progression of their disease with the safety and tolerability~     of ODM-201 being assessed throughout.~   "
97207|NCT01784744|"~     The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that~     clinical symptoms improve during fever. This fever induced amelioration of symptoms could be~     due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting~     change in the immune inflammatory system function associated with the infection or fever;~     and/or (3) and increase in the functionality of a previously dysfunctional Locus~     Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential~     direct effect an increased body temperature may have on autism symptomology. Parental~     reports have demonstrated that during febrile episodes children with ASD have improved~     social cognition and language skills, and decreased disruptive behaviors. In order to~     further explore the direct temperature effect, further investigation is needed, which the~     investigators propose below. The investigators propose to complete a one year double blind~     crossover study with 15 children with ASD between the ages of 5 and 17 years old. Five~     children with ASD will complete a control protocol prior to beginning the full protocol with~     10 additional ASD children. This will allow for any needed amendment of protocol parameters~     prior to completion of the full protocol.~   "
97208|NCT01784731|"~     Currently, office visits at general practitioners is free of charge for patients. However,~     public commissions and the Danish Economic Council have suggested to implement user charges~     for services that currently is free of charge. The aim of this study is to examine the~     consequences of introducing user charges for general practitioner services. Data for the~     project will be collected from patients who have an appointment with a general practitioner.~     Patients will be asked whether they are willing to pay a specified amount for the~     consultation that they have scheduled. After the consultation, the GP register diagnoses.~   "
97209|NCT01784718|"~     This is a single patient compassionate use protocol to determine whether Buphenyl~     (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.~   "
97210|NCT01784705|"~     Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective~     disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under~     debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate~     the neural networks of the human brain and improve cognitive performance in healthy~     subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this~     case the investigators will study the effect of transcranial bright light treatment via ear~     canals on depressive and anxiety symptoms in patients suffering from SAD in randomized~     controlled double-blind study design.~   "
97211|NCT01784692|"~     This will be a small study aimed at determining the effects of oral Immulina consumption on~     the immune system in elderly individuals.~   "
97214|NCT01784653|"~     The purpose of this study is to test the effects of a computerized, self-directed~     Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison~     to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and~     substance use. The investigators hypothesize that both iMET and MET will be more effective~     than TAU in engaging/retaining patients in treatment and in reducing substance use during a~     12-month follow-up period. The investigators also hypothesize that Self-directed iMET will~     be as effective as the clinician-guided MET in increasing treatment engagement and~     abstinence during the 12-months follow-up period.~   "
97215|NCT01784640|"~     This phase I trial studies the side effects and the best dose of Hsp90 inhibitor AUY922 when~     given together with pemetrexed disodium in treating patients with previously treated stage~     IV non-small cell lung cancer. Hsp90 inhibitor AUY922 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     pemetrexed disodium, work in different ways to stop the growth of tumor cell, either by~     killing the cells or stopping them from dividing. Giving Hsp90 inhibitor AUY922 together~     with pemetrexed disodium may kill more tumor cells~   "
97216|NCT01784627|"~     The goal of this project is to test the effectiveness of a computer-facilitated alcohol~     screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care~     patients in a multi-site, randomized comparative effectiveness trial. The investigators~     hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those~     receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups~     compared to Treatment As Usual (TAU).~   "
97217|NCT01784614|"~     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy~     Japanese participants. The study has four treatment periods. Participants will receive a~     single dose of LY2624803 or placebo in each treatment period.~   "
97218|NCT01784601|"~     Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy~     associated with interscalene block done under ultrasound guidance.~      Primary hypothesis:~      • There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an~     interscalene block.~      Secondary hypothesis~        -  The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done~          using ultrasound.~        -  The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local~          anaesthetic injected.~        -  The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of~          local anaesthetic injected.~   "
97219|NCT01784588|"~     The purpose of this research study is to compare the treatment device (Solyx) to a different~     mesh sling or control device (Obtryx II) for the treatment of symptoms for SUI. Safety~     information and patient outcomes will be collected for three (3) years and evaluated.~   "
97220|NCT01784575|"~     Numerous factors prevent consumers from making effective use of publicly reported~     information about the quality of health care, including limited recognition that quality of~     care varies between physicians, lack of awareness of the existing quality websites, limited~     internet access, and low health literacy and numeracy. In the proposed randomized controlled~     trial we will evaluate the impact of providing assistance for using and interpreting~     information about the quality of pediatric care on the Massachusetts Health Quality Partners~     Quality Insights website among a population of low income pregnant women. Results of the~     study will advance our understanding of effective strategies for overcoming barriers to~     using publicly reported information among vulnerable populations.~   "
97221|NCT01784562|"~     The aim of the study is to assess safety, tolerability and clinical effects of different~     doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension~     (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH~     trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.~   "
97222|NCT01784549|"~     -  The investigators hypothesized that NSCL patients receiving therapy based on their~          baseline tumor markers levels would attain higher response rates than patients in the~          control arm receiving non customized therapy.~        -  patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized~          therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard~          chemotherapy.~        -  The primary objective of this multicenter trial is to compare pathological complete~          response of all subjects randomized, by treatment arm.~        -  Secondary objectives are to compare all randomized subjects by treatment arm for:~          response rate, disease-free survival, overall survival, one, two and three year~          survival and safety profile.~      The study is expected to demonstrate both the feasibility of this approach and the logistic~     problems associated with a biomarker-driven therapeutic strategy in NSCLC.~   "
97223|NCT01784536|"~     The purpose of this study is to examine the effects of oritavancin on the in vivo activities~     of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail~     in an open label, single arm manner.~   "
97224|NCT01784523|"~     In this multi-center international study, our aim is to determine the effectiveness of HCQ~     for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients~     without systemic autoimmune diseases.~   "
97225|NCT01784510|"~     Randomized controlled trial comparing between two technique of laparoscopic sleeve~     gastrectomy for treatment of morbid obesity. In the first technique the investigators~     started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the~     distance was only 2 cm. The main primary outcome measure was weight loss.~   "
97226|NCT01784497|"~     Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver~     Transplantation~   "
97288|NCT01783600|"~     The objective of this clinical evaluation is to evaluate the immediate and long-term (up to~     12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective,~     non-randomised, controlled investigation for the treatment of patients with critical limb~     ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the~     level of the below-the-knee arteries.~   "
97303|NCT01783405|"~     The objective of this project is to establish the current prevalence of cardiovascular~     disease in adult subjects suffering from genetically diagnosed HF, and to know the impact~     that drug treatment has course in cardiovascular disease when compared with that of their~     affected parents with a much longer period of exposure to hypercholesterolemia~   "
97227|NCT01784484|"~     BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in~     chronic hepatitis C, however limited data are available in chronic hepatitis B and in non~     alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of~     fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are~     being followed up in the liver unit and to find associated factors with significant fibrosis~     and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan~     will be performed to all patients with abnormal liver enzymnes who attend the liver clinic.~     Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink~     consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be~     distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be~     higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and~     the same duration of disease. More over, we expect serum aspartate aminotransferase (AST)~     values will emerge as the most important independent predictive variable of fibrosis and not~     serum ALT. A significant correlations between soft drink and coffee consumption with the~     extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm~     that screening patients with elevated liver enzymes is beneficial and detect earlier the~     presence of liver fibrosis mainly in patients with NAFLD.~   "
97228|NCT01784471|"~     This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot~     symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects~     meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be~     treated with the Magic Foot™.~      If there is any significant improvement in ICG or foot symptoms as obtained from self~     evaluation questionnaire, a further 30 subjects will be enrolled.~   "
97229|NCT01784458|"~     -  Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal~          cavity~        -  many studies have proved IAP as a prognostic factor that elevated IAP influences~          hemodynamics and multiple organs dysfunction~        -  In previous studies, most of them was based on the septic patients of medical diseases.~          And it is rare about sepsis of surgical diseases such as traumatized or postoperative~          patients~        -  We hypothesized that intra-abdominal hypertension may affect clinical course such as~          length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of~          enteral feeding and mortality~        -  Our study was aimed to investigate prevalence of IAH and risk factors and to analyze~          clinical course and prognosis influenced by IAH in surgical patients with severe sepsis~   "
97230|NCT01784445|"~     Diclophenac potassium and ceftazidime are commercially available drugs that are used in~     various clinical situations. They are safe and known for years. Diclophenac potassium and~     Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis~     and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is~     currently standard treatment for prevention of (PEP) while ceftazidime is possible~     alternative treatment for patients with contraindications for nonsteroidal medicines. The~     aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.~   "
97231|NCT01784432|"~     Muscle performance is largely influenced by modulations in gene expressions of muscle~     tissue. In this context, low-level laser therapy has been used to improve muscle performance~     in experimental models and human researches. Thereby, the investigators examined modulations~     on global gene expression of muscle tissue influenced by exercise associated to low-level~     laser therapy.~   "
97232|NCT01784419|"~     This is a study of the short-term effects of ivacaftor on sweat chloride concentration and~     lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This~     new, first of its kind drug is approved for use only in CF patients with the G551D mutation~     in whom it safely confers considerable benefits. However, it is highly likely that CF~     patients with many other mutations can benefit similarly from this drug, some of whom can be~     identified by phenotype or genotype.~      We will enroll up to 30 CF subjects with clinical presentations in which there is one or~     more signs of residual CF channel function. The signs of residual function include: normal~     digestion, concentration of chloride in sweat between 55 and 85, or milder than expected CF~     disease in a CF patient with severe gene mutations. The primary outcome measure will be the~     difference in sweat chloride concentration measured in subjects on placebo and on ivacaftor.~     Secondary outcome measured will be lung function.~   "
97233|NCT01784406|"~     Women treated for gynaecological cancer perceive many difficulties in life on the personal,~     social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the~     hospital where the main purpose is to improve survival. However, the women are very nervous~     before follow-up visits and although they feel safe about them, they express that their~     needs of psychosocial care and self-management support are not fulfilled.~      The proposed study will test a person-centred intervention tailored the women's needs in a~     randomised controlled trial. The intervention will be based on the method Guided Self~     Determination (GSD), which has proved able to realize empowerment in practice in~     relationships between patients and healthcare professionals. GSD involves systematic use of~     condition-adjusted worksheets ('reflection sheets'), and advanced professional~     communication. Using reflection sheets filled out by each woman as the starting point for~     communication, problem solving will be tailored her personal needs. We expect that the~     intervention has the potential to support the women in better managing specific~     complications and difficulties related to concerns about recovery, body perception,~     fertility and establishment of intimate relations with their partner, all aspects important~     for the women's quality of life in the follow-up period after cancer diagnosis and~     treatment. The study will be the first to test GSD in cancer patients.~   "
97300|NCT01783444|"~     This study will assess the efficacy and tolerability of everolimus and capecitabine~     monotherapies compared to everolimus/exemestane combination in woman with ER + advanced~     breast cancer.~   "
97301|NCT01783431|"~     This study is for subjects with a type of skin cancer called melanoma. The main purpose of~     this study is to examine the safety of the study drug (Poly-ICLC) in patients with your~     disease. The study team would like to know about any side effects a patient may have when~     given the study drug. Another goal of the study is to determine if combining dendritic cells~     and the study drug can be possibly used as a vaccine for your disease.~   "
97302|NCT01783418|"~     The purpose of this study is to evaluate the effects of a mindfulness-based meditation~     intervention on quality of life, sleep and mood in adolescents with cancer compared to a~     control group.~   "
97234|NCT01784393|"~     Pain from bone metastases of breast cancer origin is treated with localized radiation.~     Modulating doses and schedules has shown little efficacy in improving results. Given the~     synergistic therapeutic effect reported for combined systemic chemotherapy with local~     radiation in anal, rectal, and head and neck malignancies, the investigators sought to~     evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation~     of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that~     regimens employing greater intensity radiation yield higher rates of pain relief,~     radiosensitization using a tumor targeted drug like Xeloda should improve the rate of~     complete pain relief as compared to radiosensitization with 5FU alone.~      Primary Objective:~      To determine the frequency and duration of pain relief and narcotic relief for the proposed~     regimen.~      Secondary Objective:~      To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer~     patients with bone metastases.~   "
97235|NCT01784380|"~     To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic~     indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）.~     Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as~     therapeutic effect indicatrixes of women with PCOS.~   "
97236|NCT01784367|"~     The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump~     driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid~     intubation and invasive mechanical ventilation in patients with acute respiratory failure~     retaining carbon dioxide due to the failure of their ventilatory muscle pump and not~     responding to prior non-invasive mask ventilation.~   "
97237|NCT01784354|"~     The use of acupressure will be compared to targeted Raynaud's education and will evaluate~     the` frequency, duration and pain of Raynaud's attacks.~   "
97238|NCT01784341|"~     The overall aim of this project is to compare sleep patterns and melatonin profiles in~     individuals with bipolar disorder during depression and after remission. The hypothesis is~     that sleep time, rest-activity cycles and melatonin onset will be delayed during depression~     and become less delayed after remission.~   "
97239|NCT01784328|"~     To compare the Peristeen Anal Irrigation System with conservative bowel management in a~     prospective study among spinal cord injured patients with lower motor neuron neurogenic~     bowel dysfunction.~   "
97240|NCT01784315|"~     This research is intended to study the efficacy of CQ alone for P.vivax infection and also~     to study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For~     this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since~     masking effect over one another was found when CQ is given with PQ. So the investigators are~     not sure whether the recurrence is due to resistance to CQ or CQ concentration in blood is~     below therapeutic level or it is due to PQ is in inadequate dose. From this study the~     investigators will get findings like may be CQ is still working for P.vivax or no longer~     working for P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which~     is not responding to CQ therapy, the investigators will go for second line treatment with~     ACT in a similar fashion as it is given for P. falciparum infection in Bhutan. And if the~     investigators find CQ is still working for P.vivax infection, the next level of study will~     be to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of~     bringing down the relapse rates in P. vivax infection.~   "
97241|NCT01784302|"~     This study seeks to address the question of whether antacids or multivitamins influence the~     pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise~     the dosing of raltegravir when co-administered with antacids or multivitamins.~   "
97242|NCT01784289|"~     White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies)~     through aberrant distribution (lipodystrophies), these 3 different disorders being~     paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of~     quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver~     and muscle insulin resistance, low-grade fat inflammation and immune alterations are not~     perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to~     assess different cytokines, especially interleukin 7, and metabolic parameters as well as~     fat mass distribution with DEXA and RMN, in different models of fat distribution, including~     normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue~     bank will be constituted at the same time to improve our knowledge in disorders linking fat~     mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model~     of insulin resistance.~   "
97243|NCT01784276|"~     Specific Aims Our study objective is to investigate if video peer modeling before the visit,~     plus immersive virtual reality during a preventive dental visit, reduces dental fear and~     uncooperative behaviors among children with ASD.~      SPECIFIC AIM: To pilot and test the feasibility and effectiveness of video peer modeling and~     immersive virtual reality in reducing dental fear among children with autism undergoing~     preventive dental visits.~      Methods: The investigators will enroll eighty (80) subjects aged 7-17 years with a known~     diagnosis of autism, who had a history of dental fear, per parental report.~      Study hypotheses:~      The primary hypotheses of interest are:~      (i) The mean change in the Venham Anxiety Score (VAS) over the 4 month period in children~     with ASD who receive the video intervention (Group B) is different from the mean change in~     the VAS over the 4-month period in children with ASD in the control group.~      (ii) The mean change in the VAS over the 4-month period in children with ASD who receive the~     immersive VR intervention (Group C) is different from the mean change in the VAS over the~     4-month period in children with ASD in the control group.~      (iii) The mean change in the VAS over the 4-month period in children with ASD who receive~     the video intervention plus the immersive VR intervention (Group D) is different from the~     mean change in the VAS over the 4-month period in children with ASD in the control group.~      The secondary hypothesis is:~      (i) The mean change in the Venham Behavior Score over the 4-month period in children with~     ASD in Group D is different from the mean change in the Venham Behavior Score over the~     4-month period in children with ASD in Group B or C.~   "
97244|NCT01784263|"~     The study is a randomized controlled trial to examine the efficacy of individual cognitive~     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with~     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last~     five years to the clinical needs of high-functioning youth with ASD.~   "
97245|NCT01784159|"~     Platelet activation is an important factor in the pathogenesis of microvascular thrombosis~     characteristic of infections. Microthrombosis may be related to the progression of~     dysfunction during sepsis. Several drugs were tested in order to directly regulate blood~     clotting. However, there is a lack of studies on aspirin use in sepsis. Observational~     studies have demonstrated a decreased morbidity and mortality of sepsis with previous use of~     aspirin. However, no prospective randomized studies regarding this intervention were done.~     The objectives of this study are to evaluate the impact of the use of aspirin in reducing~     organ dysfunction measured by SOFA score on the seventh day, and assess its effect on the~     duration of mechanical ventilation, ICU and hospital stay, as well as platelet activity,~     inflammatory and prothrombotic activity. Thus, adult patients with severe sepsis and / or~     septic shock with less than 48 hours will be randomly allocated into two groups. Group 1~     (ASA) will receive aspirin 200 mg and Group 2, placebo either once daily for 14 days. The~     inflammatory status and coagulation will be collected either in the D0 and D3, with~     measurements of interleukin 6, interleukin 10 and interleukin-8. The coagulation profile~     will be analyzed by measuring thrombin-antithrombin complex, thrombin time, d-dimer and~     tissue factor. The platelet activity will be evaluated by testing platelet function (PFA)~     and by measurement of urinary metabolites and thromboxane.~   "
97246|NCT01784146|"~     Objective: To assess the influence of nebulization with bronchodilators carried by the~     heliox coupled to PEP in the distribution of compartimental lung volumes in asmathic adults~     and to correlate with pulmonary function data. Methods: A controlled randomized trial~     involving 27 patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and~     oxygen. After the initial evaluation, it was placing 89 reflective markers attached to the~     surface of the trunk and images acquired by optoelectronic plethysmography (OEP) of six~     cameras. Three slow vital capacity maneuvers and quiet breathing regarded as phase control.~     After the control phase, all patients underwent nebulization with a distribution noninvasive~     system, semi-closed using 10 drops of Fenoterol Bromide and 20 drops of Ipratropium.~   "
97247|NCT01784133|"~     The purpose of this study is to evaluate th safety and efficacy of one-daily topical~     application of CLS001 low, mid and high dose compared to vehicle gel in subjects with~     papulopustular rosacea.~   "
97248|NCT01784120|"~     To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer~        1. Primary Purpose: response rate~        2. Secondary purpose: toxicity, progression-free survival, overall survival~   "
97249|NCT01784107|"~     Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of~     Belotecan and Ifosfamide.~      Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.~   "
97250|NCT01784094|"~     This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and~     no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation~     of CTMM with low back pain symptoms, disability, and functional measures. The investigators~     hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will~     be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively~     correlate with low back pain symptoms, disability and functional measures.~   "
97251|NCT01784081|"~     The main purpose of this study is to evaluate the acceptance by patients with metastatic~     pancreas cancer of integrating palliative care with usual cancer treatment. Palliative care~     intervention will involve use of pancreas cancer-specific decision aides (iPC3)about~     prognosis, treatment choices, and advance care planning for patients facing a treatment~     decision as well as symptom assessments. We hypothesize that palliative care consultations~     with iPC3 will be accepted, symptoms can be diminished, information can be received in a way~     that improves choices, and that the quality of care can be improved.~   "
97252|NCT01784068|"~     The main purpose of the study is to investigate whether nilotinib treatment can be safely~     suspended with no recurrence of CML in selected patients who responded optimally on this~     treatment~   "
97253|NCT01784055|"~     To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery~     System~   "
97254|NCT01784042|"~     The over-reaching goal of this study is to test the merit of combining dietary energy~     restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention~     strategy in overweight and obese women at high risk.~   "
97255|NCT01784029|"~     To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU~     weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of~     vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly~     Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by~     assessing change in 25(OH)D levels before and after 8 weeks of treatment.~      To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected~     musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black~     adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].~      Hypothesis 1: Increase in vitamin D level will be associated with improvement in~     musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist~     circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.~   "
97256|NCT01784016|"~     This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus~     nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and~     functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking~     relapse vulnerability.~      Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected~     concurrently in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers~     using a 3 Tesla MRI scanner configured to conduct fMRI and Positron Emission Tomography~     (PET).~      We will measure D3 receptor BP using radiolabeled [11C]-(+)-PHNO, which has a relatively~     higher affinity for D3 versus D2 receptors.~      We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers,~     there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.~   "
97257|NCT01784003|"~     The proposed study aims to characterize biological ankle joint function during walking and~     running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle~     joint torque and angle data will be collected from non-amputees while walking and running at~     multiple speeds and slopes. This data will be used to develop control parameters for a~     powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a~     powered prosthesis worn by people with below the knee amputations.~   "
97264|NCT01783912|"~     This study tests whether pre-cessation interventions known to be effective in the general~     population will increase acceptance of evidence-based treatment, engagement and compliance~     with that treatment and initial quitting success. One hundred and seventy two patients will~     be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to~     those diagnosed with persistent and serious mental illness. All participants will receive~     two group sessions (40 minutes each) modeled after Kicking Butts, a group-based quitting~     preparation program used for the past four years in two Milwaukee CSP programs run by~     Wisconsin Community Services. Individuals will then be randomly assigned to the experimental~     and control conditions (n=86 each). Experimental subjects will receive four evidence-based~     preparatory interventions (motivational interviewing, smoking reduction, practice quit~     attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~     Attention control subjects will also receive four individual sessions of the same duration.~     However their individual sessions' content will be a discussion of the personal relevance of~     the group material and will not include any of the preparatory interventions. Data will be~     collected via brief surveys taken pre-intervention, at the end of the last individual~     session, and three months later and from a database provided by the Wisconsin Tobacco Quit~     Line (WTQL).~   "
97265|NCT01783899|"~     The objective of this study is to assess the effectiveness of Hemospray in achieving initial~     hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.~   "
97266|NCT01783886|"~     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the~     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy~     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.~   "
97267|NCT01783873|"~     Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to~     induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular~     weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding~     phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new~     equipment will allow the realization of specific standardized bronchial challenges (BC) to~     occupational agents. Thus, we propose to study in more detail the cellular mechanisms~     involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled~     study.~   "
97268|NCT01783860|"~     One hundred patients with the diagnosis of posterior blepharitis based on history taking and~     proper physical examinations by two experienced ophthalmologists will include in the study.~      Patients will diagnose with posterior blepharitis if they score at least one in two symptoms~     (based on a subjective grading scale) and two signs (based on an objective grading scale) of~     posterior blepharitis according to study criteria. Patients will exclude if they have the~     following criteria: age< 12 years old,history of previous ocular or lacrimal~     surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic~     diseases with ocular involvement (except rosacea), history of usage of topical or systemic~     antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history~     of sensitivity to cyclines.~      Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the~     first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours~     for one month) in a double-blinded fashion. each patients in both treatment groups will~     accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes~     each in the treatment period. Symptoms and signs were recorded for each patient in two~     treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61~     after treatment.~   "
97269|NCT01783847|"~     The pathophysiology of Traumatic Optic Neuropathy (TON) is thought to be multifactorial, and~     some researchers have also postulated a primary and secondary mechanism of injury.TON is~     categorized as direct or indirect.In indirect TON cases, the injury to the axons is thought~     to be induced by shearing forces that are transmitted to the fibers or to the vascular~     supply of the nerve. Studies have shown that forces applied to the frontal bone and malar~     eminences are transferred and concentrated in the area near the optic canal. The tight~     adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also~     thought to contribute to this segment of the nerve being extremely susceptible to the~     deformative stresses of the skull bones. Such injury leads to ischemic injury to the axons~     of the retinal ganglion cells within the optic canal. At present, no studies validate a~     particular approach to the management of TON. There are three management lines for these~     patients that include 1)observation only;2)medical treatment with high or megadoses of~     methylprednisolone; and 3)surgical intervention. Generally no line precedes the others and~     additionally, medical or surgical interventions may result in serious side effects or~     complications. In 2005, the results of the Corticosteroid Randomization after Significant~     Head Injury (CRASH) trial raised concerns regarding the use of mega dose steroids in~     traumatic brain injury. This study was the largest randomized study that evaluated steroids~     in patients with traumatic brain injury and was stopped early due to the significantly~     increased risk of death in patients that received mega dose steroids at their 6-month~     follow-up when compared with the placebo group (25.7% vs 22.3%; Relative Risk 1.15~     Confidence Interval 1.07 to 1.24; p=0.0001). Although the etiology of the increased risk of~     death was not determined, the findings of this study should be taken into consideration when~     managing cases of TON with concurrent traumatic brain injury. Very recently it has been~     shown the cytokine hormone erythropoietin (EPO) that had been long known and used as a~     valuable agent to promote hematopoiesis has been protective in experimental models of~     mechanical trauma, neuroinflammation, cerebral and retinal ischemia, and even in a human~     stroke trial, and most notably in optic nerve transection. A double blind placebo-controlled~     multicenter trial on EPO add-on treatment in chronic schizophrenic men was performed.~     Treatment over 12 weeks with high-dose weekly (40,000 IU intravenously) EPO led to~     significant improvement of cognitive performance compared to placebo controls. Different~     studies have been performed on the effect of EPO on neuropathy in different studies. The~     investigators recently published our results on treating patients with TON with EPO and~     found it safe and effective. Patients were compared with a historical control group of~     patients who received no treatment for TON. A better visual recovery was found. The aim of~     this study is to determine the effectiveness of EPO on TON in a Multi- center clinical trial~     using a semi-experimental design.~   "
97270|NCT01783834|"~     To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for~     patients with previous treated non-small cell lung cancer~   "
97271|NCT01783821|"~     This study tested whether inhaled budesonide and formoterol were able to alleviate or~     prevent pulmonary injury when administered early in hospital course to the patients at risk~     for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses~     for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease~     (COPD), but the use of these two drugs is experimental for ARDS.~   "
97272|NCT01783808|"~     The purpose of this trial is to study the effects on exercise capacity, physical activity,~     inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used~     during physical activity, in patients with COPD who are normoxic at rest but hypoxemic~     during a six-min walk test.~      Our hypothesis is that if patients are able to use supplemental oxygen they will be more~     physically active and thereby improve health related quality of life.~   "
97273|NCT01783795|"~     This study will help the investigator determine whether certain genetic mutations, more than~     others, are a cause of more severe disease in Dent Disease.~   "
97274|NCT01783782|"~     The primary aim of this prospective, randomized and controlled study was to evaluate the~     effect of five bowel preparation regimens on small-bowel cleansing in a pediatric~     population. The secondary endpoints were to evaluate the safety and the effects of~     preparation on diagnostic yield of CE.~   "
97275|NCT01783769|"~     All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI)~     between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will~     look at the flow of staff people in and out of the operating room during surgeries and the~     effect that the number of people may have on the rate of infections in the surgical sites.~   "
97276|NCT01783756|"~     This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination~     of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+~     breast cancer with metastases in the brain who have progressed on trastuzumab.~      The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target~     different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has~     proven benefits in metastatic breast cancer may lead to improved clinical outcomes for~     participants with CNS metastasis.~      Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate~     response to the treatment, regular laboratory tests and echocardiogram or Multi Gated~     Acquisition Scan (MUGA) to assess cardiac activity~   "
97304|NCT01783392|"~     This clinical trial testing three different sites of transcutaneous electrical nerve~     stimulation for the treatment of overactive bladder (OAB).~   "
97277|NCT01783743|"~     To achieve the goal of trachoma control as mandated by the World Health Organization,~     countries must reduce the backlog of trichiasis surgery cases to less than 1/1,000 of their~     population. However, these cases reside in rural villages in trachoma endemic districts, and~     finding them to offer services is a challenge. Community Treatment Assistants (CTAs) are~     village residents who are trained to offer Mass Drug Administration (MDA) to their~     communities, and hence are in contact with most residents. A training guide and tool for~     screening for trachomatous trichiasis (TT) will be developed to train CTAs in rural Tanzania~     to identify cases in their communities and refer them to surgery. Compared to the current~     process by which CTAs passively screen for TT if cases complain, investigators hypothesize~     that the trained CTAs will identify twice the usual number of TT surgery cases during~     ongoing community antibiotic administrations for trachoma and will also miss fewer cases. If~     this simple system is effective, it can be implemented widely to screen communities for~     cases of TT.~      Thirty-six villages, for which a complete census is available, will be randomized on a 1:1~     basis to intervention (where the CTAs receive the enhanced training from the enhanced~     training team) and usual assessment (where the CTAs receive the usual instructions from the~     regular MDA team). In both sets of villages the CTAs will keep records of all cases they~     have screened as positive for TT.~      A Master TT grader will grade all screened cases of TT to determine the rate of true~     positivity. In addition, he will examine a random sample of residents who are screened as~     negative to detect potentially missed cases and estimate the total burden of trichiasis~     cases. The assessments of the Master TT grader will serve as the gold standard for~     calculations of sensitivity, specificity, and positive and negative predictive values of the~     enhanced training versus usual assessment methods.~   "
97278|NCT01783730|"~     This study was conducted to examine the safety profile and the effectiveness in daily~     clinical practice of adalimumab in rheumatoid arthritis participants showing rapid~     progression of structural damage of the joints, who had no prior history of treatment with~     disease-modifying anti-rheumatic drugs or biological agents.~   "
97279|NCT01783717|"~     The purpose of this study is to examine the effect of exenatide on body weight and glycemic~     control in subjects with obesity and/or diabetes mellitus due to hypothalamic damage.~   "
97280|NCT01783704|"~     Hip fracture is a common problem among older individuals. This year in the United States~     approximately 350,000 people aged 65 and older will break a hip. Despite improvements in~     therapy, hip fracture can still result in decreases in the strength of bone and muscle,~     making it difficult to walk and perform daily activities.~      Activity and exercise are believed to be of benefit for reducing disability in older adults,~     yet the majority of older adults do not participate in regular exercise and is not active.~     This is especially true for older adults following hip fracture after they complete the~     usual rehabilitation program.~      This study is being done to compare two 16-week supervised multi-part physical therapy~     programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want~     to test whether the interventions lead to improvements in a person's ability to walk on~     their own in the home and in the local community. With this knowledge the investigators hope~     to help a greater number of hip fracture patients enjoy a more complete recovery and~     improved overall health.~   "
97281|NCT01783691|"~     The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics~     of NKTT120 in adult patients with stable sickle cell disease.~   "
97282|NCT01783678|"~     This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV~     infection who are co-infected with HIV-1.~   "
97283|NCT01783665|"~     In addition to the typical motor and sensory impairments, individuals with multiple~     sclerosis (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive~     impairment occurs in 40 % - 70% of patients with MS. In addition, sleep problems in~     individuals with MS are very common, and approximately 50% of patients with MS have a~     diagnosable sleep disorder. The research believes that aerobic exercise improve cognitive~     function and improve sleep quality.~   "
97284|NCT01783652|"~     Objectives :~      The key objective of this study is to develop new interventions that addresses the diverse~     needs and circumstances of Hong Kong adolescents with depressive symptoms in community~     settings. Collaboration between medical professionals and social workers may prevent the~     occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in~     our adolescents.~      Methods :~      To address this intervention gap in the United States, Dr. Van Voorhees, a research~     collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a~     primary care internet-based depression prevention intervention (CATCH-IT, Competent~     Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal training). It~     has been observed clinically that the strategy could reduce depressed mood, increased social~     support and reduced depressive episodes at 12 month follow-up.~      The investigators now propose to study if an adaptation of the CATCH-IT website for Hong~     Kong Chinese adolescents may lead to significant reductions in depressed mood. In this pilot~     trial, the investigators propose to test the efficacy of the Adapted and Translated version~     of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive~     episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not~     developed depression yet.The case group will have access to the AT-CATCH website while the~     control group will only be allow to use the anti-smoking website.~      The investigators hypothesize that compared to youth in the control group, youth assigned to~     the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased~     alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group,~     youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through~     growth curve analysis and fewer depressed days over the study period.~   "
97285|NCT01783639|"~     The purpose of this study is to compare the safety and performance of WIRION™ EPD in~     patients undergoing carotid artery stenting to a performance goal based on an analysis of~     the results of previous US IDE carotid stenting with embolic protection studies~   "
97286|NCT01783626|"~     Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device,~     with respect to the hemodialyzer membrane removal characteristics. Different membrane~     prototypes configurations are proposed (3 versions in total), with the objective to modulate~     the hemodialyzer removal capacities (convective and adsorptive capacities).~      Materials(including heparin grafted specifications) as well as the sterilization process are~     identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical~     study is requested to document in vivo the different prototypes removal capacities with~     respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and~     collect data with regards to protein loss.~   "
97287|NCT01783613|"~     Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR.~     Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is~     increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all~     these alterations stimulated a chronic and bad regulated state of inflammation. For this~     porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in~     patients elder than two months old and randomized to received every day a dietetically~     supplement with DHA or placebo, will be done during 12 months. The trial has as a principal~     objective to proved if this long term supplementation could decrease in contrast with~     placebo.~   "
97289|NCT01783587|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it-such as~     the safest dose to use and the side effects it may cause.~      Afatinib has been studied in other clinical trials of participants with head and neck~     cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other~     research studies. This is the first clinical trial to study Afatinib in combination with~     Radiation Therapy.~      The purpose of this study is to determine the safest dose of Afatinib when given in~     combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy~     for head and neck cancer.~      Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by~     blocking multiple proteins known to play a role in the growth of cancer cells. Information~     from laboratory research studies suggests that this drug may help to make head and neck~     cancer cells more sensitive to Radiation Therapy.~      The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a~     chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the~     standard treatment if you have high risk disease. High risk disease means that without~     additional therapy, there is a high risk that the disease may return. In this study,~     participants with high-risk disease will receive Radiation Therapy and Docetaxel and~     Afatinib. Intermediate risk means that there is an intermediate risk that the disease may~     return. Radiation Therapy alone is the standard treatment approach for intermediate risk~     cancer. In this study, participants with intermediate risk disease will receive Radiation~     Therapy and Afatinib.~   "
97290|NCT01783574|"~     The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive~     symptoms in women with Major Depressive Disorder (MDD) and antidepressant~     partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women~     with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation~     improves fatigue and sexual dysfunction.~   "
97291|NCT01783561|"~     Premature infants are at risk of having pauses in breathing, or apneas, due to their~     immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the~     first day of life to prevent apneas. However, if they continue to have apneas, they may~     require a breathing tube to be placed in the trachea. There are risks to having a breathing~     tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it~     may decrease the need for a breathing tube. Some studies also suggest that caffeine may also~     improve heart function which may prevent low blood pressure if given early.~   "
97292|NCT01783548|"~     The purpose of this study is to evaluate the efficacy and safety of Beclomethasone~     dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).~   "
97293|NCT01783535|"~     The primary objective of this protocol is to evaluate the response rate of bilateral disease~     participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B)~     using upfront therapy with chemotherapy delivered directly to the eye. The main biology~     objective is to improve our understanding of the biology and tumorigenesis (how tumor~     develops) of retinoblastoma when biology specimens are available. As clinicians, the primary~     goal of the investigators for children with retinoblastoma is to provide optimal therapy~     using multiple treatment approaches [chemotherapy (into the vein and directly into membrane~     of eyeball), cryotherapy (freeze and destroy tumor), thermotherapy (laser or heat to destroy~     tumor), radiation therapy, and surgical removal of eye if needed) in an attempt to preserve~     the eye and vision whenever possible, while still curing the disease. Therefore, all~     children with non-metastatic retinoblastoma at St. Jude will be offered enrollment on this~     study.~      PRIMARY OBJECTIVE:~        -  To evaluate the response (complete + partial response) rate of bilateral disease~          participants who have at least one eye with advanced intraocular retinoblastoma~          (Stratum B) to two upfront courses of therapy consisting of subconjunctival carboplatin~          and systemic topotecan.~      SECONDARY OBJECTIVES:~        -  To evaluate the ocular survival of eyes and event-free survival of participants by~          strata.~        -  To prospectively analyze intraocular disease tissue for participants with at least one~          eye undergoing enucleation in order to identify the mechanism of RB1 bi-allelic~          inactivation. Participants may undergo upfront enucleation (due to advanced disease at~          diagnosis) or may receive enucleation due to progressive disease during protocol~          therapy.~   "
97294|NCT01783522|"~     This randomized phase II trial studies glutamine in preventing peripheral neuropathy in~     patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent~     peripheral neuropathy in patients receiving chemotherapy~   "
97295|NCT01783509|"~     The purpose of this study is to understand more about limb-girdle muscular dystrophy.~     Therefore, the investigators would like to track the following information collected once a~     year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle~     strength, motor function, routine examination, assessment of patient (or parent)~     understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all~     parts of your blood). By tracking this information, we hope to be able to understand more~     about the diagnosis, progression and natural history of this disorder.~   "
97296|NCT01783496|"~     The purpose of this study to evaluate treatment with the Thermage CPT system for facial and~     neck laxity.~   "
97297|NCT01783483|"~     The primary objective of this study is to evaluate sternal bone healing following a full~     median sternotomy versus standard of care for sternal closure with wire cerclage. Additional~     outcomes on post-operative pain and analgesic usage, patient function and quality of life,~     and complications will also be collected. A health economics study will also be conducted,~     in which cost and billing data will be collected from sites participating in this clinical~     study.~   "
97298|NCT01783470|"~     This study will test the hypothesis that human brown adipose tissue (BAT) can be activated~     using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared~     with cold exposure, which we have already shown can activate human BAT, as well as a placebo~     control.~   "
97299|NCT01783457|"~     Treatment delay in psychosis usually lead to slower recovery, an increase in associated~     comorbidity and greater deterioration in social and family life of patients. Previous~     studies indicate that an early intervention with guidelines for increasing adherence to~     treatment, disease awareness and condition management leads to better progression of the~     disorder and is therefore related to a better prognosis.~      Several studies have found that the rate of relapse is higher in patients with~     pharmacological treatment alone compared to those also receiving psychoeducation, who tend~     to improve their adherence to treatment and reduce toxic drugs dosage.~      Hypotheses:~        -  Individual psychoeducation will be effective as complementary therapy to~          pharmacological treatment in patients with a first psychotic episode, improving disease~          evolution.~        -  BDNF levels will increase more in the patients receiving individual therapy compared to~          those without it.~        -  Psychoeducation can be performed similarly in all participating centers if the~          therapists receive the same training and use the same psychoeducation material.~        -  The use of telemedicine for the follow-up of the patients will help improve the welfare~          work and therefore the disease evolution.~   "
97305|NCT01783379|"~     In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected~     cohort of patients with suspected or proven invasive fungal infections. Patients will~     receive micafungin for the period necessary to achieve clinical and / or mycological cure.~     An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3~     (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability.~     On non-PK days, trough samples will be taken to determine the time to steady state. All~     samples will be taken just prior to the morning dose of micafungin. All infusion rates will~     be according to the SPC label information. Patients are considered to be evaluable if at~     least the first PK curve has been completed. Two moments of PK analysis will enable us to~     determine whether there is an increase over time in exposure if steady state has not been~     reached.~   "
97306|NCT01783366|"~     we first examined whether use of tube exchange catheter during NGT insertion could increase~     the success rate on the first attempt of NGT insertion compared with conventional technique.~     We then addressed the question of whether the use of tube exchange catheter might decrease~     the possible occurrence of complication associated with YOON insertion.~   "
97307|NCT01783353|"~     Up to one-third of common warts can remain recalcitrant, an occurrence that has been~     attributed to impaired cell-mediated immunity. At present, no guidelines exist for the~     management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent,~     has shown promise in this regard. Previous studies documenting the efficacy of oral zinc~     used zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental~     zinc, which is over three times the recommended upper limit of 40 mg of elemental zinc per~     day. This raises concerns over safety and tolerability. In the Philippines, oral zinc is~     more widely available in chelated forms such as zinc gluconate, which have the benefit of~     improved absorption compared to non-chelated compounds such as zinc sulfate. This study will~     seek to determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will~     be efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the~     added benefits of increased safety, tolerability, and cost-effectiveness.~   "
97308|NCT01783340|"~     This study will assess the superior protective immunity of the combination of chloroquine~     and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a~     standard chloroquine prophylactic regimen.~   "
97309|NCT01783327|"~     The purpose of this study is to evaluate the use of a state-of the art internet~     psycho-educational program in clinical practice (Teens-Connect), compared to use of a~     standard and widely available internet diabetes program for youth (Planet D™) in a~     mixed-method randomized clinical trial design.~   "
97310|NCT01783314|"~     When someone has hepatitis C or some other condition that causes liver injury, he or she can~     develop a condition called liver fibrosis that over time, can cause the liver to stop~     working normally. Currently, the best way to determine the degree of fibrosis is to do a~     liver biopsy. The investigators hope to show that measuring the degree of liver fibrosis~     using an MRI with gadoxetate disodium is as good as or better than obtaining this~     information by performing a liver biopsy. Gadoxetate disodium is a contrast solution given~     through the veins that is considered safe, is approved for use by the Food and Drug~     Administration, and is already routinely given to patients with various forms of liver~     disease, including fibrosis.~   "
97311|NCT01783301|"~     The overall objectives of this trial are to:~        -  To explore the efficacy and safety of using either antral follicle count (AFC) or~          anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian~          stimulation for Assisted Reproductive Technology (ART).~        -  To assess the differences in both ovarian response and clinical pregnancy rate between~          subjects with different AFC and AMH levels undergoing ART.~   "
97312|NCT01783288|"~     The purpose of the study is to determine whether patients meet criteria for Postural~     Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are~     important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes~     of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands~     plasma volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and~     aldosterone are modified appropriately by changes in dietary sodium in Postural Tachycardia~     Syndrome and 3. whether patients with Postural Tachycardia Syndrome have improvements in~     their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.~   "
97313|NCT01783275|"~     It is known that obesity and/or physical inactivity greatly increase a person's risk of~     developing heart disease and other serious health problems. This is partly because diabetes~     is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also~     associated with high levels of triglycerides in the blood and tissues such as the liver~     (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause~     liver insulin resistance and impair the function of the liver and this impairment~     contributes to the development of diabetes.~      Studies have shown that both aerobic exercise and weight loss have beneficial results on~     insulin resistance. However, the cause of this benefit remains unclear. We know that both~     aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it~     is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby~     making it possible that the liver's response to insulin is also improved by weight loss~     and/or exercise training. An improved responsiveness of the liver to insulin could lower~     blood sugar levels after a meal and it could also lower morning blood sugar levels. However,~     very little is known about how exercise and/or weight loss improves liver function in people~     with type 2 diabetes.~      Hypothesis 1: Improved hepatic insulin sensitivity, as a result of either exercise training~     or weight loss, will increase the amount of glucose from an oral load that is taken up by~     the liver in subjects with DM. We also hypothesize that the amount of glucose taken up by~     the liver will be increased even further in response to exercise training plus weight loss~     compared to either treatment alone.~      Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise with weight~     loss will cause reductions in EGP during the fasted state, and will improve the suppression~     of EGP seen in response to hyperinsulinemia.~   "
97314|NCT01783262|"~     Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in~     patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.~   "
97315|NCT01783249|"~     That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and~     hematopoietic stem and progenitor cell mitochondrial function.~   "
97327|NCT01783093|"~     The purpose of this study is to evaluate patients with pulmonary hypertension and sickle~     cell disease who have had multiple echocardiograms. Previous studies have shown that an~     elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor~     of mortality. This initial data only examined an isolated TR jet velocity. It was presumed~     that the mortality was related to pulmonary hypertension.~      It is the aim of this study to retrospectively evaluate patients who have had multiple~     echocardiograms and to determine if patients who had either a normalization of their TR jet~     velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart~     catheterization had a similar mortality rate to those with persistently elevated TR jet~     velocity.~   "
97316|NCT01783236|"~     We will study the efficacy of FDA approved intravenous (IV) acetaminophen (Ofirmev, © 2011~     Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive~     thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to~     reduce the need for patient controlled analgesia and the total dose of opioids, which have~     serious side effects in thoracic surgery patients. We will compare the use of IV~     patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain.~     One group of subjects will receive IV acetaminophen every six hours beginning within 30~     minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the~     other group will receive IV placebo every six hours plus IV morphine PCA, a standard~     treatment for postoperative pain. We will determine if IV acetaminophen reduces~     post-operative morphine requirements (primary end point). We will also assess subject pain~     scores and post-operative complications associated with pain management as secondary end~     points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have~     lower total morphine consumptions compared to the placebo group.~   "
97317|NCT01783223|"~     This study is intended to evaluate the prevalence of chronically inebriated patients in the~     Emergeny Department (ED). Patients will be identified prospectively by screening all~     patients (24/7) presenting to the ED for one month. A running tally of all patients in the~     ED will be kept. Of these patients, any patient that is noted to have alcohol intoxication~     will be identified. The chart of that patient will be reviewed for details about the~     patient's alcohol use and for the patient's suitability for a sobering house, which is a~     place where intoxicated patients can go to await sobriety. The chart will also be reviewed~     for the number of previous visits for alcohol use to our hospital ever and in the last year.~   "
97318|NCT01783210|"~     The investigators evaluate if changing eating habits and introducing a correct lifestyle in~     women with BMI >25 Kg/m2 would improve unfavorable maternal-fetal outcomes associated with~     excessive weight gain (EWG) during pregnancy. To pursue these goals, eligible women are~     randomly assigned to no intervention (Control group) that receive only a simple nutritional~     booklet about lifestyle and healthy diet during pregnancy without explicit caloric~     restriction or the Therapeutic Lifestyle Changes Program (TLC group) that receive a caloric~     restriction (1500 Kcal/day divided in3 main meals and 3 snacks + 300 kcal/die for overweight~     or 200 kcal/die for obese women submitted to energy expenditure program) associated to a~     mild physical activity (30 minutes at least 3 days/week) The investigators use a tool that~     could easily and practically evaluate not only total GWG at term, but also changes in~     maternal body composition: the bioimpedance analyzer.~   "
97319|NCT01783197|"~     This research is being done because further research on selumetinib in combination with~     standard chemotherapy treatment is needed. Although the number of treatment options for~     patients with advanced non-small cell lung cancer has increased over the past decade,~     prognosis remains poor, and there is a need for additional therapeutic options.~   "
97320|NCT01783184|"~     The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is~     the subject of this observational study. 180 patients will be implanted with the Anaconda™~     Stent Graft System and will be followed-up annually for 5 years post-implant. The study will~     satisfy the requirements of the French National Authority for Health (Haute Autorité de~     santé) and the data collected will be used for reimbursement renewal.~   "
97321|NCT01783171|"~     This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt~     inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by~     surgery. Dinaciclib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
97322|NCT01783158|"~     Patients with HNSCC represent a high-risk group for the development of SESCC. Thus,~     esophagogastrofibroscopy should be performed to detect possible synchronous esophageal~     carcinomas in these patients.~      Although only two patients with synchronous primary carcinomas were found among the patients~     with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced~     endoscopic methods should be recommended after detection of HNSCC to exclude secondary~     esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an~     easy and inexpensive option and can be done in most of gastroenterology offices.~   "
97323|NCT01783145|"~     The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP)~     to follow-up patients with metastatic testicular cancer after completion of chemotherapy~     that resulted in complete remission.~   "
97324|NCT01783132|"~     To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS)~     controller treatment guided by exhaled NO measurement made at home with usual care asthma~     management with regard to asthma control (primary outcome), asthma-related quality of life,~     lung function, airway inflammation, medication use, and asthma events.~      To understand changes in patient behaviour triggered by daily FENO measurement at home, for~     example treatment adherence and voluntary allergen exposure.~   "
97325|NCT01783119|"~     The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel~     Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional~     treatment can have adverse effects and does not guarantee effectiveness in some patients~     requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a~     beneficial effect in different disease, and have an anti-inflammatory effect in UC patients.~     Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a~     period of three months, in the degree of inflammation in patients with mild UC based on Mayo~     scale and quantification of IL-6 in the colonic mucosa.~   "
97326|NCT01783106|"~     There is growing evidence that Crohn's disease may be caused by replication of bacteria,~     perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell).~     Laboratory studies show that a combination of antibiotics that can penetrate macrophages~     (such as ciprofloxacin and doxycycline) together with the anti-malarial drug~     hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps~     them to kill intracellular bacteria) is particularly effective at killing the E. coli within~     macrophages.~   "
97328|NCT01783080|"~     The investigators aimed to assess the ability of a modified version of Behavioral Activation~     for occupational and social improvement to produce change in: 1. social adjustment, 2. work~     functioning, 3. avoidance behavior and 4. behavioral activation.~   "
97329|NCT01783067|"~     Populations who consume non-fortified plant-based diets are at increased risk of iron and~     zinc deficiencies. The purpose of this randomized controlled study is to determine the~     absorption of iron and zinc from pearl millet biofortified with these two micronutrients.~     Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl~     millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron~     absorbed are measured with established stable isotope extrinsic labeling techniques and~     analyses of duplicate diets.~   "
97330|NCT01783054|"~     This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this~     research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and~     Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will~     have screening tests to determine if he or she is eligible to participate in this study.~   "
97331|NCT01783041|"~     Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early~     growth which places them at increased risk for developmental problems later in life. The~     micronutrient carnitine, which is present in breast milk and stored in the fetus late in~     pregnancy, has been shown to protect against brain injury in animal studies. Without~     supplementation, almost all preterm infants develop carnitine deficiency soon after birth.~     Thus it is important to determine if carnitine supplementation protects against brain injury~     and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that~     preterm infants supplemented early with L-carnitine while receiving parenteral nutrition~     will not develop carnitine deficiency and will have improved growth in the first two weeks~     of life and higher scores on developmental tests when compared to control infants who did~     not receive carnitine.~   "
97332|NCT01783028|"~     This study tests the hypothesis that community health workers providing home visits to~     provide education and support for self-management of asthma, assessment of the home for~     environmental triggers, resources for asthma control, and assistance in effective~     communication with medical providers over the course of one year would reduce asthma~     morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers~     among low income adults with not well controlled asthma.~   "
97333|NCT01783015|"~     The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly~     to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab~     or adalimumab plus methotrexate. This comparison will be performed for all subjects and~     separately for subjects who are anti-drug antibody positive for one of these medications.~     From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect~     of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of~     etanercept in these subjects will also be evaluated throughout the study.~   "
97334|NCT01783002|"~     The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and~     conventional SPECT-CT for the detection of abnormal parathyroid glands.~   "
97335|NCT01782989|"~     This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in~     the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).~   "
97336|NCT01782976|"~     The goal of this clinical research study is to learn if cilengitide given in combination~     with bevacizumab can help to control glioblastoma. The safety of this drug combination will~     also be studied.~      Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow~     or block the growth of cancer.~      Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or~     block the growth of cancer.~   "
97337|NCT01782963|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational combination of drugs. The purpose is to learn whether~     the combination of drugs works in treating a specific cancer. Investigational means that~     the combination of drugs is still being studied. It also means that research doctors are~     trying to find out more about it. Examples of what they want to learn about are the safest~     dose to use, the side effects it may cause, and if the combination of drugs works for~     treating different types of cancer.~   "
97338|NCT01782950|"~     Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are~     insufficient data correlating concentrations of anti-TB drugs with treatment response. We~     hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with~     inadequate TB treatment response to Mycobacterium tuberculosis.~   "
97339|NCT01782937|"~     This study is an open-label, non-controlled study to evaluate the efficacy and safety of~     KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma.~     Pharmacokinetics of KHK4827 will also be assessed.~   "
97340|NCT01782924|"~     This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in~     subjects with moderate to severe plaque psoriasis who have completed the preceding Study~     4827-002.~   "
97341|NCT01782911|"~     Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual~     irregularity and hyperandrogenism and is the most common cause of oligoovulatory~     infertility. Insulin resistance with resulting hyperinsulinemia is also common among women~     with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related~     cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic,~     anti-proliferative and pro-apoptotic properties, that has been shown to decrease~     proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent~     in PCOS patients. However, little is known about its potential beneficial effect on oocyte~     quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The~     present study evaluates effects of resveratrol on selected biochemical parameters and~     reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).~   "
97362|NCT01782638|"~     Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved~     gait in parkinsonian patients. However, sometimes the investigators observed a gait~     aggravation either with using high voltage and high frequencies, either because of~     suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to~     explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus~     due to a diffusion of the electric stimulation current to the fibbers going near STN area.~      The primary purpose of this study is to compare the effect of deep brain stimulation with~     high frequency versus low frequency on gait of patients whatever the electrodes placement~     (STN ou Forel fields) and whatever the medication condition (with or without treatment).~   "
97342|NCT01782898|"~     Seventy percent of surgeries performed in the United States are done in an outpatient~     setting.Pain Control after ambulatory surgery is very challenging because patients do not~     have access to fast and potent intravenous medications Pain after ambulatory surgery is~     poorly controlled in the United States with up to seventy five percent of patients having~     moderate to severe pain after ambulatory procedures. Postoperative pain have been associated~     with serious morbidity, including myocardial infarction and pulmonary embolism.~      The use of intraoperative opioids can result in an exaggerated response to pain~     (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids~     are commonly given intraoperative, not in response to pain, but in response to hyperdynamic~     cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to~     treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown~     to have central antihyperalgesic effects that might contribute to a reduction in~     postoperative pain. It is therefore conceivable that the use of intraoperative esmolol~     instead of opioids to avoid hyperdynamic states during surgery can result in lower~     postoperative pain. Since postoperative pain can substantially affect postoperative quality~     of recovery, it is also conceivable that the use of intraoperative esmolol might result in~     an improved postoperative quality of recovery to surgical patients.~      The main objective of the current study is to examine the effect of intraoperative esmolol~     on postoperative quality of recovery. A secondary objective is to examine the effect of~     esmolol on postoperative pain.~      Significance: Postoperative pain after ambulatory surgery has been shown to be poorly~     managed in The United States. The goal of this study is to investigate if a change in the~     intraoperative pharmacologic management of patients undergoing ambulatory surgery can~     improve their postoperative quality of recovery and pain.~      The research question is; does the use of intraoperative esmolol improve postoperative~     quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve~     postoperative pain after ambulatory surgery?~      The hypotheses of this study is; does the use of intraoperative esmolol improves~     postoperative quality of recovery after ambulatory surgery. The use of intraoperative~     esmolol reduces postoperative pain after ambulatory surgery.~   "
97343|NCT01782885|"~     The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular~     injection therapy is effective as an alternative treatment option in patients with mild knee~     osteoarthritis within a controlled randomized study compared to first line treatment~     acetaminophen. The investigators will evaluate patients outcome in level of pain, knee~     function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.~      The study will be complemented with in vitro experiments of human osteoarthritic cartilage~     explants culture (treated with PRP) for histological and gene expression assays.~      PRP intra-articular injections therapy is effective in patients with mild knee~     osteoarthritis by modifying the biochemical joint environment and cartilage regeneration~     capability.~   "
97344|NCT01782872|"~     The purpose of this study is to determine which medication(s) should be included in the~     interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in~     the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement).~     The ideal nerve block would reduce pain after shoulder surgery without causing a great deal~     of muscle weakness.~   "
97345|NCT01782859|"~     Studies have shown that surgery causes some reactions in your body consistent with~     inflammation. When the inflammation is extensive, it may affect different parts of the body~     including the lungs. Corticosteroids are commonly used to treat inflammation and are~     different from performance enhancing steroids associated with athletics. The purpose of this~     study is to determine the influence of low dose steroids given 3 times in a 24 hour period~     on thrombotic markers (markers that are associated with increased risks of clotting, a~     possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress~     response seen with surgery), and urine desmosine levels (a marker of lung injury) in a~     randomized placebo controlled trial patients undergoing total hip replacement.~   "
97346|NCT01782846|"~     Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®,~     Dafalgan-Codeine®) in the emergency unit.~      The efficacy (relief of pain) would be assessed 2 hours after administration of one of the~     two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain~     assessment score).~   "
97347|NCT01782833|"~     This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this~     study is observational in nature to collect the safety data after administrating the Pletaal~     SR capsule, from baseline to 16 weeks.~   "
97348|NCT01782820|"~     The aim of the present study is to compare the time course of a neuromuscular block in~     patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting~     several hours before surgery with patients receiving the drug immediately before induction~     of anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is~     the time from start of injection of rocuronium until recovery to a train of four ratio (TOF~     ratio) of 0.9.~   "
97349|NCT01782807|"~     The impact of Hysterectomy with preservation of the ovaries on ovarian function has long~     been controversial. studies have shown conflicting data regarding ovarian function after~     simple Hysterectomy.~      In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have~     preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the~     consequences regarding ovarian function have yet to be established.~      The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs.~     Hysterectomy combined with salpingectomy or fimbriectomy~   "
97350|NCT01782794|"~     The present study is conducted in order to assess the acceptability of Hepatitis B~     vaccination in French general population before and after reimbursement of the paediatric~     vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the~     others at year 1, 2 and 3 after reimbursement.~   "
97351|NCT01782781|"~     The aim of the study is to evaluate traditional analgesic therapy after abdominal~     hysterectomy with single infiltration of local anesthetics in the surgical area at the end~     of surgery.~   "
97352|NCT01782768|"~     Background: The efﬁciency of Neural respiratory drive (NRD)expressed by a ratio of~     ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD~     .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical~     symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is~     a good treatment to AECOPD patients.It is unknown the effects of different mode of~     noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation~     (PAV) and pressure-support ventilation (PSV) on the efﬁciency of Neural drive of AECOPD and~     which mode benefit the patients more.~      Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and~     proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of~     AECOPD~   "
97363|NCT01782625|"~     The investigators will simulate the conditions of a working, helmeted diver by using~     exercising, head out immersed subjects to test the following hypotheses:~        1. An algorithm can be developed which predicts cognitive performance in immersed~          exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's~          inspired partial pressures of oxygen and nitrogen (PIO2 and PIN2).~        2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide~          (PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at~          levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165~          fsw density of 6.8 g/l).~   "
97353|NCT01782755|"~     Probiotics are commercially available live bacteria thought to have health benefits when~     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found~     that in patients who receive probiotics, there is a 25% reduction in lung infection, known~     as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of~     developing any infection in the ICU. However, the studies reviewed were small and not well~     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large~     carefully performed study is done to evaluate the effects of probiotics in critically ill~     patients, a pilot trial is needed. The investigators plan to study the feasibility of such a~     trial in mechanically ventilated ICU patients in 11 ICUs in Ontario, investigating whether~     orally ingested L. rhamnosus GG (a common probiotic) prevents VAP and other infections. The~     4 goals of the pilot study will be to ensure that we can successfully enrol patients; follow~     the protocol faithfully; make sure patients don't receive additional probiotics, and~     estimate how much pneumonia exists in these patients. In a separate substudy, the~     investigators will evaluate the effects of probiotics on lower lung infiltration with~     potential harmful bacteria, stool bacteria, markers of immunity called cytokines, and~     markers of infection called endotoxin levels. The investigators plan to enroll 150 adults~     admitted to ICU and receiving mechanical ventilation. Following informed consent, patients~     will be randomized to either L. rhamnosus GG group or an identical placebo. Twice daily,~     patients will receive probiotics or placebo in a feeding tube. The investigators will record~     all infections and other important outcomes in the ICU. This study is very important in the~     ongoing search for more effective strategies to prevent serious infection during critical~     illness. Probiotics may be an easy-to-use, readily available, inexpensive approach to help~     future critically ill patients around the world.~   "
97354|NCT01782742|"~     Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic~     pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and~     removal. The study drug bexarotene is an FDA approved anti-cancer agent but is not~     approved for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced~     Aβ (harmful protein) in the brain in experimental models of Alzheimer's disease.~      This study aims to determine the safety and effect on abnormal proteins found in the brain~     (based on brain scans) of 300 mg of bexarotene administered for one month compared to~     placebo (inactive agent).~   "
97355|NCT01782729|"~     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in~     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very~     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic~     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease~     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in~     pediatric participants.~   "
97356|NCT01782716|"~     Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main~     objectives of this study is to calculate mortality probability by two different risk score~     system and to inquire effects of informing anesthesiologist and surgical team; of score of~     the patient; on length of hospitalization and intensive care and also on actualized~     mortality.~   "
97357|NCT01782703|"~     Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder~     of children, affecting 10-20% of children and 1-2% of adults.~      This skin disorder can be associated with unbearable itchiness and an increased~     susceptibility to skin infections. The cause of AD is currently poorly understood;~     therefore, there are no targeted treatment options at present. There have been recent~     studies in adults with AD that explain the cause and give us new routes to investigate~     treatment options, however no major studies in this arena have been done in children. We~     hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare~     them to adult AD.~      Hypothesis: The immune system worsens the skin barrier issues that are common in atopic~     dermatitis. We believe there are similar immune and skin abnormalities in adult versus~     pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic~     dermatitis can serve as surrogates for skin immune activation and will correlate with~     disease severity.~   "
97358|NCT01782690|"~     This observational study will evaluate the impact of rash on survival of patients with~     metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further,~     clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12~     months.~   "
97359|NCT01782677|"~     The primary aim of the study is to determine safety, tolerability and feasibility of~     bilateral carotid body resection in patients with systolic heart failure and peripheral~     chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of~     bilateral carotid body resection.~   "
97360|NCT01782664|"~     A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy~     of GSK2586184 in patients with chronic plaque psoriasis.~      There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this~     part of the study will be randomised, double-blind and placebo-controlled. Fifty-six~     subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg~     or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of~     the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood,~     and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all~     subjects will take 400 mg GSK2586184.~      In both Cohorts A and B, study medication will be administered orally (as tablets), twice~     daily, for up to 12 weeks.~      Each subject will have 7 out-patient visits: Screening; Baseline & Start of treatment; Week~     2; Week 4; Week 8; Week 12; and Follow-up (Week 16)~   "
97361|NCT01782651|"~     This study will describe the treatment paradigm used over recent years in the clinical~     management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in~     Hungary. This information will provide insight into real-world exposure and adherence to~     anti-HER2 therapy containing regimens, and improve understanding of the reasons for~     discontinuation of this therapy.~      This is a retrospective, descriptive, cohort study of approximately 180 female patients~     diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with,~     or who progressed to, metastatic disease between 01 September 2009 and 01 September 2010~     will be included. All patients will be followed until death, loss to follow-up or the end of~     the study period (30 September 2012). All data will be collected retrospectively from~     patient medical records.~      Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic~     breast cancer patients, including sites of metastases, the time from initial breast cancer~     diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of~     HER2 will be described. Further, descriptive statistics of the proportion of HER2+~     metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of~     different therapies, and the duration of therapies in the metastatic setting will be~     analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive~     statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic~     treatment pathway, time to treatment discontinuation and time to progression (TTP) on~     lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type~     and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine~     and, where relevant, after lapatinib+capecitabine will be performed.~   "
97396|NCT01782196|"~     Certain research and innovation projects require an assessment of the adhesive properties of~     adhesives, which cannot be established from in-vitro testing. The most valuable data for~     assessments of this type comes from adhesion and wear time studies involving application to~     living human skin on volunteers. The purpose of the study is to assess the safety and~     performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in~     a group of subjects with an ileostomy.~   "
97364|NCT01782612|"~     Postoperative recovery is always worrisome to the elder patients undergoing Total Hip~     Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic~     nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious~     papers suggested PNBs were commonly administered in conjunction with general anesthesia~     (GA), or the blocks were performed primarily for postoperative analgesia. Hardly any~     research has reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style~     for Total Hip Replacement (THR). The investigators compare peripheral nerve blocks to~     general anesthesia on elderly eld patients undergoing Total Hip Replacement (THR) by~     assessing the Postoperative Recovery and Delirium~   "
97365|NCT01782599|"~     The purpose of this study is to determine whether electronic cigarettes can reduce~     reactivity to smoking-related cues.~   "
97366|NCT01782586|"~     The purpose of this study is to determine if certain genes found in a kidney biopsy~     performed at one-year post transplant can predict which transplanted kidneys will have~     decreased kidney function within five years post transplant.~   "
97367|NCT01782573|"~     To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more~     effective on the reduction of surgical site microbial colonization and subsequent infection~     than is normal saline.~   "
97368|NCT01782560|"~     Noisy breathing is commonly caused by a floppy voicebox which is a condition called~     laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have~     suggested that it could be due to acid escaping from the stomach and spreading up the~     swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is~     therefore one of the most common reasons for infants to see Otolaryngologists at BC~     Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms~     including squeaky breathing, choking, difficulty feeding, failure to gain weight, and~     episodes of turning blue (due to lack of oxygen).~      At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia~     medication to reduce the amount of acid they make in their stomachs, in the hope that this~     will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed~     whether anti-reflux medication will benefit these children any more than doing nothing at~     all.~   "
97369|NCT01782547|"~     Hospitalization of youth with established diabetes is both costly and frequently~     preventable. Poor glycemic control is a risk factor for hospitalization and is also~     associated with adolescent age and lower socioeconomic status. This is a randomized,~     controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control~     with an intervention arm and usual care control arm matched for frequency of contacts. There~     will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the~     Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention~     will be implemented by a diabetes nurse educator and social worker, who will each have~     monthly contact with the adolescent and a parent/guardian through a telehealth~     (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth~     interventions have been utilized successfully in both adults and youth with diabetes. They~     facilitate frequent contact with the care team allowing barriers to adherence to be~     addressed, education to be reinforced, care plans to be updated, and diabetes-specific~     family support to be provided.~   "
97370|NCT01782534|"~     The relevant predictive hospital risk factors for 5-year mortality of patients with aortic~     dissection is untill unlear. The aim of this study is to collect the clinical data of 111~     hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically~     analyze the hospital risk factors related to 5-year mortality by univariate and multivariate~     binary logistic regression.~   "
97371|NCT01782521|"~     Orthodontic treatment is carried out by placing fixed attachments(brackets)on teeth with~     wires which run through them and create tooth movement. These metal brackets are bonded~     (glued) onto the tooth surface by a three step process. Firstly, a mild acid is used to~     roughen the tooth surface, secondly a free flowing glue (composite primer) is used to fill~     in the roughened pores and thirdly, the bracket is glued on to the tooth surface with a~     'composite' material which sets hard by exposure to a high intensity light.The success of~     this procedure is measured by bracket failure rates.~      The literature review suggests that the scientific evidence is not clear to indicate whether~     the use of a primer is absolutely essential to achieve acceptable bracket success rates in a~     clinical environment.~      The primary aim of the study is to find out if the rate of loss of orthodontic brackets is~     clinically acceptable when they are glued onto the tooth surface without the use of a primer~     as compared to brackets bonded with a primer over a 12 month study period. The investigators~     will also investigate the Bonding time,Type of bracket bond failure,length of treatment and~     Peer Assessment Rating scores (PAR)~      This RCT will be undertaken on consented NHS patients in 3 hospitals in Yorkshire region by~     multiple operators~      The results from this study will help improve our knowledge of the best approach to bonding~     metal brackets on teeth. If the bracket failure rate is similar in both groups, this would~     indicate that the use of a primer is not always necessary. For patients, this would mean~     lesser time required to place brackets at the start of orthodontic treatment. For clinicians~     and NHS purchasers the outcome will influence cost effectiveness (as the primer is the most~     expensive component in the bonding process) and provide a framework for future studies.~   "
97372|NCT01782508|"~     The purpose of this study is to compare the relapse free survival and overall survival of~     Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary~     tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit~     mutation. It is assumed that Gleevec may be more effective on relapse free survival as the~     adjuvant treatment compared with Interferon.~   "
97373|NCT01782495|"~     This is a study to evaluate chronic Hepatitis C Virus infection.~   "
97374|NCT01782482|"~     The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as~     compared to FRESHLOOK® COLORBLENDS contact lenses.~   "
97375|NCT01782469|"~     This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of~     adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable~     synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants~     with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from~     participants receiving adalimumab treatment who had not been treated with any other~     anti-tumor necrosis factor (anti-TNF) therapy in the past.~   "
97376|NCT01782456|"~     The objective of this study is to capture information on gastrointestinal tolerance (GI) of~     an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3~     to ≤ 10 years.~   "
97433|NCT01781715|"~     The purpose of this study is to determine outcomes (death, myocardial infarction, target~     vessel revascularization (TVR), non-target vessel revascularization (non-TVR),~     stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and~     multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous~     coronary intervention with Zotarolimus-eluting stents~   "
97377|NCT01782443|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug, Ziv-aflibercept, is being studied. It also means that~     the FDA has not yet approved Ziv-aflibercept for use in patients with your type of cancer.~      Every person has molecules in their bloodstream called vascular endothelial growth factors~     (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.~     Cancer tumors hijack this mechanism because they need new blod vessels and oxygen to grow.~     Ziv-aflibercept is an antibody. Antibodies are proteins that are produced naturally in our~     bodies and help to recognize foreign substances in our body. Ziv-aflibercept is a targeted~     therapy called a VEGF Trap, that traps (binds) these VEGFs and prevents the cancer from~     using them to grow.~      Though Ziv-aflibercept has not yet been FDA approved for the treatment of carcinoid tumors,~     it has recently been approved for patients with treatment-resistant colorectal cancer.~      In this research study, we will use Ziv-aflibercept in combination with standard octreotide~     therapy to see if it slows the growth or spread of your carcinoid tumor. Standard octreotide~     (sandostatin) therapy is currently approved for treating symptoms of carcinoid tumors, such~     as those caused by carcinoid syndrome. Carcinoid syndrome is caused by hormones and other~     substances released by carcinoid tumors into the bloodstream. One of these secreted~     substances is serotonin, one of the body's natural chemical messengers. When excess~     serotonin secreted by the carcinoid tumors reaches the body's tissues, it is thought to~     cause diarrhea and redness (flushing) of the face, chest or back. Excess serotonin may also~     cause changes in the structure of the heart valves, which can impair the heart's function.~     Octreotide works by binding to receptors found on carcinoid tumors and prevents the release~     of hormones from the tumor.~   "
97378|NCT01782430|"~     Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the~     intubation of hypoxemic patients.~   "
97379|NCT01782417|"~     Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to~     non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have~     a higher prevalence of arthritis-attributed activity limitations (primarily related to OA),~     are less likely to receive hip replacement independent of health care access, and are less~     likely to receive knee replacement. The study is conducted to develop and test a telephone~     delivered intervention for the management of OA in Hispanic adults. This study is conducted~     as a minority supplement to the Patient and Provider Interventions for Managing~     Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.~   "
97380|NCT01782404|"~     This a prospective, non-controlled, open, multi-center study evaluating the reduction of~     bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with~     chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated~     with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.~      The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short~     term reduction of bacteriuria in patients performing intermittent catheterization (IC).~   "
97381|NCT01782391|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in~     young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a~     memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory~     activity typically occuring during SWS has been implicated in the consolidation effect.~     Recent evidence in young healthy subjects suggest that the sleep-associated consolidation~     effect can be amplified by the application of a weak transcranial oscillatory electric~     current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients~     with amnestic mild cognitive impairments (MCI)- usually characterized by initial~     difficulties in hippocampus dependent memory functions - benefit from transcranial slow~     oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far.~     The primary aim of the present study is to investigate the influence of a weak slow~     oscillating brain stimulation (tSOS) on declarative memory consolidation applied during~     periods of nocturnal SWS in MCI patients.~   "
97382|NCT01782378|"~     The purpose of this study is to learn if an experimental treatment can help thinking~     ability, and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental~     treatment uses light-emitting diodes (LEDs), that are applied outside the skull, to the head~     using a helmet that is lined with near-infrared diodes. LEDs are also placed in the nostrils~     (one red diode: and one near-infrared diode), to possibly deliver photons to the deeper~     parts of the brain. A treatment takes about 30 minutes. The participants receive a series of~     LED treatments which take place as outpatient visits at the VA Boston Healthcare System,~     Jamaica Plain Campus. The LEDs contain red and near-infrared diodes. The FDA considers the~     LED device used here, to be a non-significant risk device. The LEDs do not produce heat.~   "
97383|NCT01782365|"~     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is~     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its~     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory~     representations. This impact of sleep on memory performance can be additionally enhanced by~     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the~     frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in~     young, healthy subjects. If patients with amnestic mild cognitive impairment (MCI)- usually~     characterized by initial difficulties in hippocampus dependent memory functions - benefit~     from transcranial slow oscillatory stimulation (tSOS) during sleep as well has not been~     studied so far. The primary goal of the study is therefore to investigate the impact of~     oscillating current stimulation (tSOS) during a daytime nap on declarative memory~     consolidation in MCI patients.~   "
97384|NCT01782352|"~     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in~     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence~     and/or progression of age-related macular degeneration (AMD).~   "
97393|NCT01782235|"~     Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by~     lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of~     glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and~     fatigue. One third of patients develop systemic features, the most severe being lymphomas.~      Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a~     pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell~     differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R~     antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate~     the efficacy of tocilizumab for the treatment of pSS.~   "
97394|NCT01782222|"~     This trial is being conducted to assess the effects of Rotigotine over Placebo on~     improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage~     idiopathic Parkinson´s Disease.~   "
97385|NCT01782339|"~     The treatment of germ cell tumours is considered to be one of the major successes in the~     area of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a~     durable remission rate of between 25% and 60% has been seen using further chemotherapy. In~     1999, researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination~     chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results~     from this study showed that 50% of patients with relapsed testicular cancer could be cured~     using this treatment. When we reviewed the individual patients it was clear that older~     patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that~     monitors cancer activity), did not do as well. In addition, patients whose original tumour~     started in their chest (mediastinal germ cell tumour) have tended to do badly if they~     relapse. We have been developing a study for patients who fulfil at least one of these~     criteria. The GAMIO study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin)~     has recently closed due to problems with high levels of toxicity from the irinotecan. GAMMA~     is a new study that will use paclitaxel instead of irinotecan and oxaliplatin instead of~     cisplatin. We expect that this treatment with oxaliplatin will be less damaging to the~     kidneys than cisplatin. Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have~     similar activity in relapsed patients in the phase II setting. We hope to improve on our~     previous results with this substitution and see if this will lead to an improvement in the~     cure rate of relapsed germ cell tumours with poor prognosis and reduce the side effects~     compared to our standard treatment. In addition, we do not expect any hearing damage and the~     treatment requires a shorter hospital stay.~   "
97386|NCT01782326|"~     This study will assess the efficacy, safety and tolerability of QVA149 in patients with~     moderate to very severe COPD.~   "
97387|NCT01782313|"~     This study is for patients who have been diagnosed with soft tissue sarcoma that has spread~     (metastasized) or that is not eligible for removal by surgery. The purpose of this study is~     to determine how soft tissue sarcomas respond to treatment with an investigational drug~     called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere~     with the growth of some types of tumors. The study will also evaluate how safe the study~     treatment is by observing how many and what kind of adverse events (side effects)~     participants experience.~   "
97388|NCT01782300|"~     Dengue viruses can cause dengue fever and other more severe forms of disease. This study~     will evaluate the safety and immune response to two doses of a dengue virus vaccine given 12~     months apart in healthy adults.~   "
97389|NCT01782287|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of brain metastases of lung cancer (BMLC) involves allogeneic~     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic~     lymphocytes (CTLs).~      TCs and TSCs are isolated from BMLC sample. Dendritic cells are isolated from peripheral~     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to~     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are~     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)~     administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort~     demonstrating efficiency continues the therapy, while cohort demonstrating no efficiency is~     transferred to active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to~     targeted regulation of therapeutic cell systems with specific properties, are detected in~     TSCs using complete transcriptome profiling of gene expression, proteome mapping and~     profiling of proteins, bioinformation and mathematical analysis and mathematical modeling of~     protein profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs~     regulation are detected, as well as protein ligands able to regulate reproductive and~     proliferative properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-based HSCs.~      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line~     therapy.~   "
97390|NCT01782274|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of brain metastases of breast cancer (BMBC) involves allogeneic~     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic~     lymphocytes (CTLs).~      TCs and TSCs are isolated from BMBC sample. Dendritic cells are isolated from peripheral~     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to~     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are~     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)~     administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort~     demonstrating efficiency continues the therapy, while cohort demonstrating no efficiency is~     transferred to active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to~     targeted regulation of therapeutic cell systems with specific properties, are detected in~     TSCs using complete transcriptome profiling of gene expression, proteome mapping and~     profiling of proteins, bioinformation and mathematical analysis and mathematical modeling of~     protein profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs~     regulation are detected, as well as protein ligands able to regulate reproductive and~     proliferative properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-based HSCs.~      Autologous HSCs, DV and CTLs are administered as in the first line therapy.~   "
97391|NCT01782261|"~     Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune~     cells in healthy subjects and patients with type 1 diabetes~   "
97392|NCT01782248|"~     The aim of this study is to characterize the deficit in critical components of personal~     identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD)~     and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a~     neuropsychology and multi-podal neuroimaging study.~      We posit that the alteration of some aspects of self-consciousness (autobiographical memory,~     nosognosia, metacognition) and social cognition (theory of mind and facial) results in~     personality changes in the patients, primarily due to the alteration of self-consciousness~     in AD and to social cognition in FTLD.~   "
97395|NCT01782209|"~     The objectives of this study is to establish the natural history of BK virus viremia and~     other possible opportunistic viral pathogens in renal transplants receipients.~   "
97434|NCT01781702|"~     A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap.~     for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients~   "
97397|NCT01782183|"~     Thermographic cameras are used to determine temperature and temperature differences.~     Attempts have been made to use the thermographic camera as a diagnostic tool in clinical~     practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast~     cancer. The camera absorbs infrared radiation which is discharged from the tissue and than~     translates it to a digital data or a photograph. The camera does not radiate and direct~     contact with the patient is not needed. The safety is similar to a regular optic camera. No~     study on thermographic characteristics of inflammation of organs has been published. The~     purpose of this study is to demonstrate and document these characteristics of inflammation.~     The correlation between the thermographic imaging and the clinical diagnosis, using routine~     methods, will be analyzed. The differences of thermographic imaging between an inflamed~     organ of a subject to a non inflamed same organ of a normal control will also be analyzed.~     The management of the patient will be by standard practice and will not be influenced by the~     thermographic camera image and the study outcome.~   "
97398|NCT01782170|"~     The purpose of this study is to explore the efficacy of Iocide oral rinse in a human~     clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse.~     Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed~     to determine the effect of the antimicrobial oral rinse on relative levels of biological~     markers of inflammation.~   "
97399|NCT01782157|"~     The world's population is aging and the resulting prevalence of chronic illnesses is a~     challenge that our society must address. The vision is to address this challenge by~     designing smart environment technologies that keep older adults functioning independently in~     their own homes as long as possible. Smart environments have been used as the basis of~     monitoring activities for residents with health conditions. However, there is currently a~     lack of large scale, longitudinal research to identify early markers of dementia and other~     health status changes and to predict functional decline. The objective of this project is to~     perform a 5-year longitudinal study of older adults performing daily activities in their own~     smart homes.~   "
97400|NCT01782144|"~     Obesity is a serious medical, social, and economic problem and is becoming even greater~     concern, as the prevalence of overweight and obese individuals has steadily increased over~     the years. Excessive body weight can have a profound influence on lower extremities,~     including pain, degenerative disease, and compromised quality of life. However, no study~     to-date has examined the effects of weight change on foot structure and function in~     individuals over time. The purpose of this study is to determine the effects of weight~     reduction on foot structure and function in obese adults. Improved understanding of the~     relationship between body weight and foot biomechanics is needed to promote health and~     healthier lifestyles.~   "
97401|NCT01782131|"~     The purpose of this study is to evaluate the safety and efficacy of posaconazole versus~     voriconazole in the treatment of adults and adolescents with invasive aspergillosis (IA).~   "
97402|NCT01782118|"~     Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux~     disease (GERD). However, they may be associated with an increased risk of gastrointestinal~     and respiratory tract infections.~      Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the~     risk of gastrointestinal and respiratory tract infections in children with GERD.~      Study design: Randomized, double-blind, placebo controlled trial.~   "
97403|NCT01782105|"~     The purpose of this study are:~        -  Assess the impact of an intervention to the adoption of healthy lifestyles among~          pregnant women at high risk of gestational diabetes mellitus on:~             -  weight gain in pregnancy~             -  the levels of maternal and fetal adipokines and~             -  glycemic control maternal and fetal.~        -  Determine whether the adoption of healthy lifestyles in pregnancy is associated with~          epigenetic changes that influence the levels of adipokines and glucose regulation~          during pregnancy and in newborns.~   "
97404|NCT01782092|"~     The purpose of this study (15-subject prospective case series) is to examine the effects of~     the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes~     Mellitus (aka adult-onset diabetes).~   "
97405|NCT01782079|"~     The aim of this study is to select the optimal conditions for quantification in the oral~     cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available~     dietary supplement and to assess its persistency after oral administration. Different sets~     of primers for L. brevis detection will be tested in real-time PCR reactions to find optimal~     amplification efficiency and target specificity. Primers ability in the identification of L.~     brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically~     free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on~     the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and~     saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning~     before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last~     tablet. The quantities of L. brevis DNA will be compared to the total number of bacteria~     present in the samples. The activity of the enzyme arginine deiminase, responsible for oral~     pH homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva~     samples before and after treatment, by HPLC measurements.~   "
97406|NCT01782066|"~     Invasive meningococcal disease is a worldwide problem with serious repercussions for those~     affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is~     prohibitive in many low-resource settings at home and abroad. By harnessing the special~     immunologic properties of the skin, a dose reduction may be achieved by intradermal~     administration of the vaccine. The cost savings associated with dose reduction will increase~     availability of the vaccine.~   "
97407|NCT01782053|"~     Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and~     Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette~     packs as well as nine new statements of smoking risks. This trial tests the effectiveness of~     the warnings proposed by the Food and Drug Administration by providing cigarettes with the~     proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In~     addition, the trial tests the effects of different warning label components.~   "
97462|NCT01781338|"~     Trial for the optimization of risk assessment and therapy success prediction in patients~     with early breast cancer by the use of biomarkers in advance to therapy decision-making to~     personalize therapies.~   "
97408|NCT01782040|"~     Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a~     woman's menstrual cycle. These symptoms occurring only during the luteal phase of the~     menstrual cycle that are of sufficient severity to interfere with some aspects of life of~     these women, reflecting also in interpersonal relationships, workplace and in their~     productivity. For these reasons, this research was conducted with the nursing staff of the~     Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to~     alleviate some of the symptoms of PMS.~   "
97409|NCT01782027|"~     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol~     administered intravenously in association with albumin, as a method to study reverse~     cholesterol transport (RCT) in people carrying mutations in genes known to affect high~     density lipoprotein (HDL) metabolism by analyzing changes in the tracer activity in total~     plasma, lipoproteins fractions and feces.~   "
97410|NCT01782014|"~     The purpose of this study is to determine which of the methods of colonoscopy viz. water~     insufflation or air insufflation or carbon dioxide insufflation is better in detecting the~     adenomas in colon and also which of these methods is best tolerated by patients.~      Hypothesis: the investigators hypothesize that in patients undergoing first time screening~     colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group~     randomized to the water method compared to those randomized to the air or CO2 insufflation~     methods~   "
97411|NCT01782001|"~     The purpose of this study was to determine whether young children receiving Vitamin A and~     Zinc supplements will have a lower incidence of symptomatic malaria than similar children~     receiving vitamin A supplements alone.~   "
97412|NCT01781988|"~     Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and~     thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance~     to platinum agents 、 gemcitabine and pemetrexed respectively.~      Tailored therapy using these molecular determinants suggested patient benefit in a~     previously reported phase 2 trial. Here, we designed a study for an individual patient~     analysis of prospectively accrued patients who were treated with the personalized therapy~     approach versus other standard approaches.~   "
97413|NCT01781975|"~     Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing~     ß cells. Although exogenous insulin is widely available, it is not possible for affected~     individuals to consistently achieve euglycemia with current technology, and thus they are at~     risk for devastating long-term complications. This phase II study is designed to evaluate~     the safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib~     is a first-in-class tyrosine kinase inhibitor.~      This study will explore the potential role of short-term therapy with imatinib to induce~     tolerance and possibly lead to a durable long-term remission of T1DM.~   "
97414|NCT01781962|"~     This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or~     Ocular Hypertension.~   "
97415|NCT01781949|"~     The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening~     methods, including a novel targeted strategy, in urban emergency department settings in the~     United States.~   "
97416|NCT01781936|"~     The purpose of this study is to determine the tolerability, safety, and benefits of an~     investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have~     posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical~     implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat~     non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology~     (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room.~     Initially, this was a 2-dose randomized pilot study. However, the study was modified to~     include only the 0.2 ug/day implant.~   "
97417|NCT01781923|"~     The goal of this study is to collect preliminary data on the efficacy of a cognitive~     remediation program in improving the neurocognitive deficits in children with chromosome~     22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a~     computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a~     Social Cognitive Training (SCT) program. The computer-based training program has shown~     encouraging results in improving learning deficits in individuals with schizophrenia and we~     now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ~     and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group~     intervention program based on cognitive enhancement therapy, which has been shown to improve~     social cognition and functionality in adults with schizophrenia. A preliminary study will be~     performed using this two-pronged approach, to establish the feasibility and gather~     preliminary data on neurocognition before and after the intervention in these children;~     these data would enable a larger randomized controlled study to assess the efficacy of this~     approach.~   "
97418|NCT01781910|"~     The purpose of this study is to determine if a dietary supplement containing branched chain~     amino acids will reduce the muscle soreness that sometimes occurs in the days following~     exercise.~   "
97419|NCT01781897|"~     The purpose of this study is to investigate the effect of electroacupuncture on functional~     constipation.~   "
97420|NCT01781884|"~     This study is a multicenter, randomized, double-masked, placebo-controlled clinical study.~     All groups will receive standard intensive diabetes treatment with insulin and life style~     management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or~     different dosage of GABA.~      GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was~     approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used~     as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has~     been recently shown that GABA can prevent and reverse the development of diabetes in type 1~     mice models. Participants will receive placebo or GABA for 52 weeks.~      The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks~     treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.~      To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in~     new onset subjects.~   "
97483|NCT01781065|"~     The purpose of this study is to evaluate the analgesic effect of transcranial direct current~     stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have~     chronic neuropathic pain.~   "
97421|NCT01781871|"~     Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant~     morbidity and mortality in both otherwise healthy adult population and in the~     immunocompromised patients. The incidence rate of invasive pneumococcal disease is~     considerably higher among organ transplant patients than in healthy individuals. Routine~     immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after~     the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide~     vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine~     has been shown to be more immunogenic and safe in some other subgroups of immunocompromised~     patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal~     conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal~     polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.~   "
97422|NCT01781858|"~     The course of both pulmonary embolism (PE) and one of its more relevant late complications,~     i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.~      Recent evidence has shown that the incidence of CTEPH is higher than previously believed,~     but this has not been confirmed by other studies. A clear link between PE and CTEPH has been~     questioned by some experts. A great number of patients affected by PE persistently have~     residual chronic thromboembolic material the meaning of which is a matter of debate. The~     evidence sustaining a link between chronic residual PE and subsequent PE recurrences or~     CTEPH is insufficient.~      Thus, a nationwide, multicentre, prospective cohort study was designed with the following~     aims:~        1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;~        2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first~          episode of acute PE;~        3. to evaluate whether a relation exists between chronic residual PE and CTEPH~        4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;~        5. to evaluate whether a relation exists between persistent right ventricular dysfunction~          and CTEPH;~        6. to evaluate whether a relation exists between persistent right ventricular dysfunction~          and PE recurrences.~      For each enrolling centre, consecutive outpatients or inpatients with an objectively~     diagnosed first acute PE episode are considered eligible.~   "
97423|NCT01781845|"~     Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be~     either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by~     ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed~     systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by~     measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave~     velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves~     as the reference standard.~   "
97424|NCT01781832|"~     Urinary bladder fibrosis is relatively uncommon in children. Traditionally, the presence of~     urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic~     testing. In this study we will use ARFI (acoustic radiation force impulse)-derived shear~     wave velocities to potentially identify any urinary bladder wall fibrosis.~   "
97425|NCT01781819|"~     Urine reflux (urine backing up into the kidneys) is common in the pediatric population and~     may be complicated by renal abnormalities, such as infection and scarring. Currently, urine~     reflux is detected using either voiding cystourethrogram or other procedures. A new~     technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave~     velocity imaging SVI) is performed using standard approved ultrasound machines and~     transducers bu the sound waves/impulses are produced in a different pattern. We hope to~     evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine~     reflux (urine backing up into the kidneys).~   "
97426|NCT01781806|"~     The purpose of this study is to evaluate the safety, acceptability and feasibility of~     delivery of PrEP or PEP as part of combination HIV prevention services for high-risk MSM and~     transgender women.~   "
97427|NCT01781793|"~     Exertional dyspnea is a major source of crippling distress and is the hallmark symptom of~     fibrotic interstitial lung disease (ILD). Due to the scientific community's poor~     understanding of the pathophysiological mechanisms of dyspnea there are no therapeutic~     interventions that consistently reduce dyspnea in this population. The investigators aim to~     determine the physiological mechanisms of exertional dyspnea in patients with fibrotic ILD~     and the impact of hyperoxia on exertional dyspnea and exercise endurance. This study will~     likely identify an important physiological mechanism of dyspnea in fibrotic ILD and may~     contribute to the development of effective therapies to reduce dyspnea in this population.~      The central hypothesis is that dyspnea in fibrotic ILD is primarily a result of an imbalance~     between the drive to breathe and the tidal volume response of the respiratory system (i.e.,~     neuromechanical uncoupling) and that experimental reduction of neuromechanical uncoupling~     via hyperoxic breathing will reduce exertional dyspnea and improve exercise endurance.~   "
97428|NCT01781780|"~     This is an experiment that will compare the effect of recommending breakfast consumption, or~     breakfast skipping, on body weight. Our objective is to determine if breakfast consumption~     recommendations can produce weight loss, and if that weight loss is dependent on typical~     breakfast eating habits.~   "
97429|NCT01781767|"~     This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2)~     mRNA expression as function of thyroid activity (TSH, T3 and Free T4).~   "
97430|NCT01781754|"~     Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin~     A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose~     levels, high free fatty acids and high oxidative stress.~      The investigators intend to learn about the changes in UCP2 along the process of reaching~     glycemic control.~   "
97431|NCT01781741|"~     This pilot clinical trial studies stereotactic body radiation therapy after surgery in~     treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation~     therapy may be able to send x-rays directly to the tumor and cause less damage to normal~     tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in~     patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after~     lymphadenectomy may kill any tumor cells that remain after surgery.~   "
97432|NCT01781728|"~     The investigators are looking to see if a certain dose of stereotactic body radiation~     therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or~     periampullary adenocarcinoma.~   "
97435|NCT01781689|"~     Stroke is the most common cause of motor function impairment. However, the functional~     impairment is not totally irreversible. Several mechanisms may involved in both the cortical~     and motor function recovery after onset of stroke, and most of them are related to changes~     of cortical perfusion and metabolism.~      Motor function recovery after stroke (especially middle cerebral artery territory lesion)~     frequently follow stereotypic pattern (brunnström stage).~      This study is designed to investigate the relationship between motor cortex~     oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar~     stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage~     after stroke.~   "
97436|NCT01781676|"~     This study was advocated by institute of Basic Research in Clinical Medicine,China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized specialized project~     for 'significant new formulation of net drugs'.~      Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart~     diswese、angina pectoris and stroke in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
97437|NCT01781663|"~     The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face~     Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will~     be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of~     subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group),~     versus a group of subjects treated with a petrolatum-based moisturizer (the control group).~     Safety will be determined by the number and severity of Adverse Events Device-Related.~   "
97438|NCT01781650|"~     Water-aided method for colonoscopy can be broadly subdivided into two major categories.~     Water Immersion (WI), characterized by suction removal of the infused water predominantly~     during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by~     suction removal of infused water predominantly during the insertion phase of colonoscopy.~     Several studies showed that WE significantly reduces pain compared to WI and colonoscopy~     with traditional air insufflation (AI), increases the number of unsedated procedures and~     adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial~     will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test~     the hypothesis that WAC (particularly WE) would significantly decrease pain score during~     colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.~   "
97439|NCT01781637|"~     The investigators will perform a double blind, placebo controlled clinical trial with Xolair~     (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut~     allergy. The investigators will determine if pretreatment with anti-IgE mAb~     (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer~     desensitization.~   "
97440|NCT01781624|"~     The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional~     supplement containing a new protein blend in healthy elderly subjects.~   "
97441|NCT01781611|"~     Dipyridamole, a medication extensively used in combination with aspirin for stroke~     prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit~     certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of~     lupus-related pathology in mice with lupus. The investigators are interested in~     investigating the efficacy of dipyridamole in preventing flares in patients with lupus and~     its impact on biomarkers of disease activity.~   "
97442|NCT01781598|"~     Description of logistics, learning curve and radiological results in 70 patients treated~     with patient specific instrumentation in total knee arthroplasty as a standard procedure~   "
97443|NCT01781585|"~     Hemodynamic instability occurs frequently during dialysis treatment and still remains as~     significant cause of patient mobility and mortality. Postoperative hemodynamic optimization~     has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased~     can lead to further structural and functional impairment owing to its deleterious effect on~     the compromised microcirculation and metabolism. This study was to compare the~     intra-cerebral pressure (ICP) and hemodynamic parameters between the sustained~     low-efficiency dialysis (SLED) and continuous veno-venous hemofiltration (CVVH) in post-~     brain tramatic patients.~   "
97444|NCT01781572|"~     In the phase Ib, the primary purpose is to establish the maximum tolerated dose~     (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally~     administered combination. Once the MTD(s)/RP2D have been determined for each tested~     schedule, additional patients will be enrolled in the phase II portion of the study at the~     RP2D on the chosen schedule in order to assess the anti-tumor activity of the combination in~     addition to continued evaluation of safety.~   "
97445|NCT01781559|"~     The objective is to demonstrate the effect of phenolic acids on endothelial function.~   "
97446|NCT01781546|"~     The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of~     bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with~     DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in~     patients at high risk of bleeding.~   "
97447|NCT01781533|"~     To investigate the performance of a software-algorithm based insulin therapy to control~     blood glucose in Type 1 diabetic patients.~   "
97448|NCT01781520|"~     The purpose of this study is to evaluate the antitumor effect and safety of clinical~     effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK)~     for unresectable locally advanced pancreatic cancer.~   "
97449|NCT01781507|"~     Primary Objective :~      To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized~     levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years~     old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.~      Secondary Objective:~      To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two~     weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who~     have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.~   "
97528|NCT01780480|"~     To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula~     (Fangji) based on differentiation of syndromes (Zhenghou) according to the theory of~     traditional Chinese medicine for improving the symptoms in the convalescent phase of~     ischemic stroke, and to establish the pharmacodynamic model of Zhenghou according to the~     results of this trial.~   "
97450|NCT01781494|"~     The goal of this study is to test the hypothesis that immediate elbow motion is safe after~     anterior submuscular ulnar nerve transposition, and will not result in disruption of the~     repaired flexor pronator origin, under which the nerve is placed. The advantages of~     immediate elbow motion after submuscular ulnar nerve transposition for performing activities~     of daily living and self-care are evident, however theoretical advantages include early~     gliding of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent~     traction neuritis, as well as improved blood flow and quicker, more complete, recovery of~     nerve function.~      A group of 44 consecutive patients that are determined to be candidates for anterior~     submuscular ulnar nerve transposition based on history, positive findings on physical~     examination, and confirmatory electrodiagnostic testing will be prospectively randomized to~     either immediate motion or long arm cast immobilization after surgery. All patients will be~     counseled about the two postoperative treatment options (immobilization followed by~     protected range of motion versus immediate range of motion), risks involved with each~     treatment protocol, postoperative follow-up and need for radiographs. If they choose not to~     participate, they will be treated by the same postoperative protocol currently used by the~     principal investigator: arm sling at rest for six weeks with intermittent active assisted~     range of motion exercises.~   "
97451|NCT01781481|"~     The investigators have recently developed a paediatric adaptation of the INTERMED tool to~     address the unique developmental and social contexts of children and youth. The Pediatric~     INTERMED adopts a life-chart methodology to structure and organize complex case material in~     time, colour-coding domains to facilitate identification of areas of high need and risk for~     each patient. The focus of the present study is to examine the characteristics and~     usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with~     Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children~     and parents will participate in a semi-structured structured interview with a clinical nurse~     who will then rate the 34-PIM items. To examine the construct validity of each of the~     Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care~     system) participants will complete questionnaires assessing social and psychological~     functioning, parent and family stress, quality of life and adaptive functioning. Information~     about disease status, and health care utilization will be obtained from medical chart~     review. It is hypothesized that greater case complexity will be predictive of more complex~     disease course/treatment, poorer quality of life, and increased health care utilization.~   "
97452|NCT01781468|"~     This randomized phase III trial studies armodafinil to see how well it works in reducing~     cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve~     fatigue in patients with high grade glioma.~   "
97453|NCT01781455|"~     This is an open label, single arm dose escalation study of BBI503 in adult patients with~     advanced solid tumors.~   "
97454|NCT01781442|"~     This is a post marketing surveillance which determines the safety profile of the product to~     Filipinos. This is a FDA requirement for registration.~   "
97455|NCT01781429|"~     This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and~     pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The~     study also seeks to demonstrate target modulation and early signs of clinical response in~     select patient populations.~   "
97456|NCT01781416|"~     This is a national, non interventional, prospective study performed in the general practice~     setting.~      The study has been designed :~        -  to assess the level of concordance between patients' cardiovascular risk perception and~          the cardiovascular risk evaluated by the physicians,~        -  and to evaluate the impact of patients' exposure to a medical information leaflet on~          patients' cardiovascular risk perception.~   "
97457|NCT01781403|"~     The investigators planned a phase I study of preoperative CRT with capecitabine plus~     temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of~     temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low~     expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in~     20~40% of colorectal cancer patients, and this proportion could be adequate for validation~     as its role of predictive biomarker, and 3) temozolomide can be additive or synergistic~     because radiotherapy is now essential in the treatment of rectal cancer.~   "
97458|NCT01781390|"~     This is a double blind, randomized, placebo controlled study that will enroll 225 subjects~     with de novo anterior myocardial infarction due to a lesion of the left anterior descending~     coronary artery undergoing PCI. Eligible subjects will be enrolled and undergo~     revascularization of the culprit LAD followed by an intracoronary (IC) delivery of the~     assigned treatment, infused into the stented culprit artery. The study will determine the~     safety and feasibility of the IC infusion of investigational MPCs in this patient~     population.~   "
97459|NCT01781377|"~     Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean~     section.~      Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor~     trigger zone and is used effectively for the prevention and treatment of nausea and~     vomiting. Propofol can antagonize Serotonin receptors in the area postremal and is~     associated to a reduced incidence of postoperative nausea and vomiting. Some studies have~     shown that propofol can prevent intraoperative nausea and vomiting during cesarean section.~      The control of risk factors and the pharmacological prophylaxis of nausea and vomiting~     reduces effectively their incidence.~      In this randomized, double blind, case-control study the efficacy of propofol alone,~     metoclopramide alone and in combination in controlling nausea and vomiting were compared. A~     risk factor control strategy was associated to each study group.~   "
97460|NCT01781364|"~     The purpose of this study is to reveal the specific effects of computer-aided cognitive~     training on course and rehabilitation in early onset schizophrenia~   "
97461|NCT01781351|"~     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim~     of our study is to quantify the stabilizing effect of different devices. Through the~     combined use of the 3D motion analysis and the surface electromyography, the influence of~     the devices with respect to a mechanical effect and to an influence on the neuromuscular~     control are examined. The tests will simulate situations with a higher risk of injury. In~     the experimental set-up, an element of surprise will be integrated in order to analyze any~     muscular compensation mechanisms.~   "
97463|NCT01781325|"~     Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to show patients~     how to reproduce at home the exercises prescribed by their physical therapist (PT) in~     clinic. The IBEHR can also record home exercise sessions for review by and feedback from the~     PT. The HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer~     of physical therapy exercise from clinic to home, increased adherence to the exercise~     prescription, and recording home exercise to assist PT decision making.~   "
97464|NCT01781312|"~     Recent studies have shown an increased gastrointestinal reactivity and increased intestinal~     permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the~     gastrointestinal immune system possibly by improvement of both the immunologic and the~     non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have~     an effect on IgAN. In this study the investigators will study the efficacy and safety of~     Lactobacillus reuteri.~   "
97465|NCT01781299|"~     The purpose of this study is to assess the relative performance and complication rates~     between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of~     these two treatment options.~   "
97466|NCT01781286|"~     The purpose of this study is to examine the effects of normal vs. protein-rich afternoon~     snacks on appetite control, satiety, and reward-driven eating (particularly in the evening)~     in young people. Indices of attention and mood will also be assessed.~      Study hypotheses include the following:~        1. The consumption of a high-protein, soy-rich afternoon snack will lead to significant~          improvements in appetite control and satiety, reductions in food motivation and reward,~          and will delay the drive to eat in normal to overweight young people.~        2. The consumption of a high-protein, soy-rich afternoon snack will lead to reduced~          unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal~          to overweight young people.~        3. The daily consumption of a high-protein, soy-rich afternoon snack will lead to~          significant improvements in afternoon alertness, concentration, fatigue, and well-being~          in normal to overweight young people.~   "
97467|NCT01781273|"~     This four-way, dose-response, crossover, double blind, placebo-controlled, randomised~     validation study investigates the responsiveness of MedDrive, a computed battery of~     neuropsychological tasks, to different doses of alcohol.~      The following hypothesis are tested:~        1. Measures from MedDrive are influenced by alcohol in a dose dependent way.~        2. Effects of alcohol on driving performances are correlated to measures from MedDrive in~          a dose dependent way.~        3. Within a group of healthy young drivers, MedDrive shows consistent results over~          repeated measures (ICC≥0.7).~        4. MedDrive models effects of alcohol on driving performances better than does the UFOV or~          the trial making task.~   "
97468|NCT01781260|"~     Recent occurrence of significant post-operative liver impairment at Nottingham University~     Hospitals NHS Trust has prompted investigation into whether interaction between general~     anaesthesia and prone positioning (lying face down) for surgery can influence liver~     function.~      Historical research has shown that the heart does not function as efficiently when an~     anaesthetised patient is placed in the prone position for surgery. The techniques used for~     anaesthetising and monitoring these patients have changed remarkably, since these studies~     were first performed.~      It is important to know accurately how the heart functions to enable better understanding of~     the changes in blood flow to the liver when in the prone position.~      Studies looking at blood flow to the liver when lying face down have been done before but~     are mainly reporting patients on the intensive care unit. These intensive care patients are~     different to those in theatre undergoing routine surgery. The intensive care patients are~     usually received in different types of drugs and monitored with several different types of~     monitor at the time. Perhaps most importantly is that they are placed face down on a soft~     air cushioned mattress and pillows rather than the rigid support used for surgical patients.~      This study will look at whether the function of the liver changes when a patient is~     anaesthetised and is then rolled onto their front. The function of the liver will be~     measured by looking how it clears a specific drug from the blood. Also this study will look~     at how accurate a particular type of heart monitor is when an anaesthetised patient is~     placed onto their front.~   "
97469|NCT01781247|"~     Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone~     experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to~     the traumatic experience of myocardial infarction (MI). PTSD is associated with impaired~     quality of life, social functioning, and high economic burden to the society. Posttraumatic~     stress attributable to MI has also been shown to be predictive of poor cardiovascular~     prognosis, whereby this link might relate to several atherothrombotic processes. Therefore~     the prevention of PTSD after MI is of high relevance. Guidelines have been published for~     early interventions to prevent the development of posttraumatic stress after different types~     of trauma but not in terms of acute MI as a traumatic event.~      The overarching aim of the planned trial is to test whether a minimal behavioral~     intervention performed shortly after acute MI in patients at a high risk to develop PTSD and~     in the setting of a coronary care unit reduces the development of posttraumatic stress.~      The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be~     at least 20% lower in the intervention group than in the control group, and that this effect~     will last up to 12 months after the intervention. The secondary hypothesis is that the~     intervention group will show better psychosocial functioning, and a more favourable~     cardiometabolic biomarker profile than the control group 3 and 12 month after the~     intervention.~   "
97470|NCT01781234|"~     This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers.~     Groups' (placebo vs. insulin) cognitive function and stress response will be compared.~   "
97471|NCT01781221|"~     The purpose of this study is to compare the regenerative results of using separately two~     different xenografts after two-step sinus floor elevation.~   "
97472|NCT01781208|"~     ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound~     guided needle biopsy of the liver of children.~   "
97577|NCT01779830|"~     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy~     people. The study has four treatment periods. Participants will receive a single dose of~     LY2624803, another sleeping pill, or placebo in each treatment period. The study will last~     approximately 1 month for each participant.~   "
97473|NCT01781195|"~     Prolonged-release low-dose Advagraf should better protect from CNI-side effects compared to~     standard immunosuppressive regiments while the rate of rejection is not increased and thus~     graft function is well maintained. We hypothesize that especially in high-MELD (MELD-score~     >20) recipients who have a decreased immune competence the prolonged-release low-dose~     Advagraf concept would better protect from side effects of immunosuppression (i.e.~     infection). Nevertheless, we assume that also patients with a MELD-score ≤20 will benefit~     from this concept in regard to lower infection rates and less side effects of~     immunosuppression.~   "
97474|NCT01781182|"~     Escalating resistance to antibiotics among disease-causing community bacteria increasingly~     threatens our ability to treat patients' infections. At the level of the physician-patient~     encounter, incentives at the patient level often take priority to society; this is often the~     case with antibiotic prescribing. Each patient level antibiotic treatment decision is based~     on how we value potential outcomes, including short-term benefits and risks and longer-term~     risks, including those related to future bacterial resistance to antibiotics. Unfortunately,~     antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a~     very small likelihood of benefit seems to outweigh an increased risk of future antibiotic~     resistance. While short-term effects of antibiotics on colonization with resistant bacteria~     have been demonstrated, the overall implications of each treatment for future individual,~     family and societal-level resistance remain difficult to quantify, and are often steeply~     discounted or ignored during decision-making. Knowledge regarding the longer-term effects of~     personal and household antibiotic use could better quantify these future resistance-related~     risks, and help guide antibiotic decision-making for physicians and patients.~      Infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the~     1st year of life, become important reservoirs of resistant organisms; this creates an~     opportunity to study colonization and resistance starting from a microbiological tabula~     rasa. In this proposal, we will use an observational cohort to following newborns'~     antibiotic exposure and longitudinal colonization with specific bacterial pathogens and~     related antibiotic resistance in the 1st year of life. Our hypothesis is that during the 1st~     year of life, infants with personal and household antibiotic exposure will have greater~     colonization with resistan organisms than infants without antibiotic exposure. This project~     will help us understand the development of bacteria that are resistant to antibiotics within~     the community, and help to inform judicious decision-making regarding antibiotic~     prescribing.~   "
97475|NCT01781169|"~     Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid~     Hormone and Insulin Resistance in Obese Chinese Males.~      Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight~     weeks to the obese males compared with the normal-weight males. Index measures were~     conducted at baseline and endpoint.~   "
97476|NCT01781156|"~     Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in~     end stage renal diseases(ESRD),however the majority of whom are in the absence of acute~     coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in~     those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To~     confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in~     hemodialysis patients for some time and observed the change of cardiac biomarkers of those~     patients.~   "
97477|NCT01781143|"~     The SOET project introduces a new strategy for routine follow-up of follicle growth during~     the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a~     learning instruction and demo, patients should be able to perform most of their vaginal~     echoes at home. The images can be sent to the medical center over the internet. These images~     are analyzed by the expert.~   "
97478|NCT01781130|"~     Background~      Present treatment strategies for trigger finger when conservative management including~     steroid injection was failed include percutaneous or open A1 pulley release, but some people~     showed prolonged swelling and delay of complete healing.~      We aimed to test the hypothesis that an improved outcome can be achieved by employing~     steroid injection simultaneously with percutaneous release compared with conventional~     percutaneous release alone~      Methods~      We designed a double-blind, randomized controlled trial.~      Inclusion criteria is the patient who has symptom of trigger finger warranted surgical~     release after sufficient time of conservative treatment.~      Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid~     arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5)~     Previous surgery history of finger 6); the patients who got steroid injection more than 4~     time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.~      After power analysis by a statistician, total 40 patients would be required for each group~     (percutaneous alone group versus percutaneous alone + steroid injection group).~      The surgery will be performed by outpatients clinic basis with local injection. Additional~     steroid injection will be given to half of patients after allocation with randomized~     selection by permutaed block randomization.~      Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary~     outcome will be proportion of patients with good response (defined as Perfect or much~     better as reported by patients).~      Follow-up will be conducted 3 weeks and 3 month after index procedure~   "
97479|NCT01781117|"~     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in~     symptomatic failure in more than one third of the patients. Storage symptoms are major~     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate~     (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and~     smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased~     after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients~     with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of~     the BPO by the medical or surgical treatment have not been fully investigated. If the~     elevated urinary NGF levels are reduced after successful surgical treatment of BPO,~     measurement of urinary NGF could be a useful objective tool to assess the therapeutic~     outcomes of the operation.~      The aims of this study are to measure the urinary NGF levels in patients with BPO and to~     compare the results between the patients with detrusor overactivity (DO) and without~     detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the~     Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of~     postoperative 3 months and 6 months, and compare changes between the two groups.~   "
97480|NCT01781104|"~     The purpose of this study is to evaluate safety and tolerability as well as the effects of~     RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other~     abdominal symptoms in patients with chronic constipation.~   "
97481|NCT01781091|"~     Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to~     extubation or death in ICU patients requiring mechanical ventilation measuring duration of~     mechanical ventilation in order to design a multicenter large trial.~   "
97482|NCT01781078|"~     The objective of the SAMURAI Clinical Study is to collect data to confirm the safety,~     performance and effectiveness of the ImageReady System for use in the Magnetic Resonance~     Imaging (MRI) environment when used in accordance with the Conditions of Use included in the~     Boston Scientific MRI Technical Guide~   "
97484|NCT01781052|"~     This prospective, non-interventional, multi-center study documents observational data on~     subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III~     with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The~     observation period for each subject covers a one year treatment period with inhaled~     Ventavis. For each subject, the investigator or a delegate collects data as defined in the~     case report form at an initial visit, routine follow-up visit at 6 months and final visit at~     12 months.~   "
97485|NCT01781039|"~     Understanding speech is essential for good communication. Individuals with hearing loss and~     poor speech discrimination often have little success with hearing aids because amplifying~     sound improves audibility, but not clarity of the speech signal. The purpose of this study~     is to determine the relative importance of the sensory cells of the inner ear and auditory~     neurons on speech discrimination performance in quiet and in noise. This information may be~     used as a predictor of hearing aid benefit. The investigators expect to find decreased~     speech understanding ability resulting from both loss of sensory cells and the loss of~     auditory neurons.~   "
97486|NCT01781026|"~     The purpose of this trial is to study the activity of vemurafenib in untreated melanoma~     brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations~     that are not amenable to stereotactic radiosurgery based on size, number of lesions or~     location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of~     central nervous system penetrance and to measure levels of vemurafenib in normal brain~     tissue and brain metastases in those in whom surgical management is feasible.~   "
97487|NCT01781013|"~     The specific aims of the proposed study are to:~        1. Develop the innovative depression care management technology, including the speech~          recognition technology for automated monitoring and patient prompts over time,~          automatic integration of the responses into the patient registry, and evidence-based~          decision-support algorithms for care actions;~        2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services~          (LAC-DHS) clinics to test the interventions;~        3. Use mixed-method evaluation to assess the extent of the implementation of the~          interventions, the acceptance to the providers and to the patients, and the impact on~          adoption of depression screening and treatment management over time, utilization, and~          cost of healthcare services, and patient health outcomes; and~        4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of~          the study will demonstrate which Comparative Effectiveness Research (CER) adoption~          strategies are successful and why, their comparative cost-effectiveness, as well as~          which strategies are successful under which circumstances to inform system-wide~          implementation of same.~      Hypotheses of the Proposed Study~      The following are the main hypotheses of the study:~        1. There will be statistically significant difference in the adoption of depression care~          screening and management over time among the three study groups.~           1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) >~          Usual Care (UC).~        2. There will be statistically significant difference in the depression symptom reduction,~          and better functional status, and quality of life among the three study groups.~           2.1. The difference between the TC and the SC will not be statistically significant,~          but both will be greater than the UC group.~        3. There will be statistically significant difference in the diabetes care process and~          outcomes among the three study groups.~           3.1. The difference between the TC and the SC will not be statistically significant,~          but both will be greater than the UC group.~        4. There will also be statistically significant differences in healthcare utilization~          among the three study groups, with least utilization in the TC group where the greatest~          level of technology is applied.~        5. Of the three groups compared, the TC group will be the most cost-effective approach for~          accelerating adoption of the CER depression care results.~   "
97488|NCT01781000|"~     The purpose of this study is to reveal the specific effects of computer-aided cognitive~     training on cerebral reorganization in schizophrenia~   "
97489|NCT01780987|"~     The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE~     subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as~     initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total~     treatment period is 24 weeks)~   "
97490|NCT01780974|"~     The primary aim of the pilot study is to provide data that can be used to better determine~     sample size for the design of a larger clinical trial. The pilot will evaluate the~     effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing~     Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment~     rate, safety, and compliance over the 12 month study period.~   "
97491|NCT01780961|"~     To create an esophageal cancer biospecimen repository that will collect, annotate, store and~     distribute human esophageal cancer biospecimens in a manner that embraces the highest~     ethical standards of human subject's research, that conforms to the best practices of~     biorepository science and that furthers basic, translational and clinical research in the~     understanding diagnosis and treatment of this disease.~   "
97492|NCT01780948|"~     Hypothesis : In renal transplantation recipient who received immunosuppressive drug~     certican and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase~     inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450~     subfamily 3A4 both, so investigator made the hypothesis that when patients received~     everolimus with atorvastatin will change area under the time concentration curve of~     everolimus.~   "
97493|NCT01780935|"~     This study will evaluate and compare two individualized ranibizumab treatment regimens in~     patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual~     function benefit, while aiming to avoid unnecessary intravitreal injections.~      The results will be used to generate further recommendations on functional and anatomical~     monitoring of the disease and timing of treatment administration for patients with~     neovascular AMD. In this context, the study will investigate the utility of optical~     coherence tomography (OCT) to aid retreatment decisions with ranibizumab.~   "
97494|NCT01780922|"~     The purpose of this study is to determine the effects of a single dose of cranberry beverage~     in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites,~     and antioxidative and anti-inflammatory activity.~   "
97503|NCT01780805|"~     This study involves completion of questionnaires, computer-based cognitive tasks and an~     alcohol drinking session. Participation in this study consists of an initial, in-person~     screening appointment, 4 brief daily appointments at the research office, an alcohol~     drinking session at a local bar and a follow-up appointment 1-3 days after the alcohol~     drinking session.~      Participants who are found to be eligible in the screening phase will then complete a daily~     appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on~     which they will not attend an appointment). Each appointment will last 20 minutes, on~     average and consist of a questionnaire and computer-based cognitive task. On the day of the~     fourth appointment, participants will complete an alcohol drinking session. The alcohol~     drinking session begins at 4pm and lasts until at least midnight.~      Participants in this study will be young adults between the ages of 21-25, who regularly~     drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two~     participants will complete this study.~   "
97495|NCT01780909|"~     Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as~     marker for the evaluation of the gastrointestinal transit. By collecting and analyzing both~     gastric and intestinal fluids on different time points, the transfer dissolution can be~     distracted. For this study stomach fluid and intestinal fluid will be collected after oral~     intake of a commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral~     tablet formulation), which is dissolved in a glas of 240mL water, in fasted or fed state.~     Four intake conditions will be tested on four different test days (with an intermediate~     period of at least 7 days).~        1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~          240mL water, in fasted state.~        2. intake of Gabbroral® oral tablet formulation in fed state.~        3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake~          of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL~          water.~        4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the~          intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~          240mL water.~      Conduct of the study~        -  The study consists of four testing days in the University Hospitals Leuven,~          Gasthuisberg campus.~        -  On each test day you come at the agreed time in fasting State to the Gastroenterology~          Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that~          you have eaten nothing for 12 hours for the investigation and only have been drinking~          water.~        -  A basic clinical anamnesis will be taken by a doctor to make sure that you are a~          healthy volunteer for our study. For making sure that you are HIV negative, you will~          undergo an HIV test. In case of a female volunteer, a pregnancy test will be taken in~          account to make sure you are not pregnant.~        -  Upon arrival at the hospital through the nose or the mouth two probes: one in the~          stomach and one in the gut. The position of both probes is controlled using fluoroscopy~          (x-ray).~        -  After a stabilisation period of ca. 20 min you will be asked for taking a single dose~          of Gabbroral® oral tablet formulation. On four different test days, with an~          intermediate period of at least 7 days, we will follow every one of following intake~          conditions:~             1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water, in fasted state.~             2. intake of Gabbroral® oral tablet formulation in fed state.~             3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the~               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water.~             4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the~               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water.~        -  After intake of the medicine at regular intervals, gastrointestinal fluids will be~          aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping~          is not permitted (after 2 hours you have the possibility to drink some water).~        -  After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam~          freely.~   "
97496|NCT01780896|"~     The purpose of this study is to evaluate visual and nonvisual topographic memory impairment~     and its relationship to vestibular function in humans. Topographic memory refers to the~     ability to remember current and past locations in topographic (navigational) space and to~     make and/or adjust to spatial transformations using such memories. Performance on each of~     these topographic memory tasks will be compared to performance on a set of comparable~     nontopographic memory tasks. Topographic impairments represent some of the earliest~     cognitive deficits observed in Alzheimer's Disease, and the brain areas involved in~     topographic memory are the first to show degenerative changes.~   "
97497|NCT01780883|"~     Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in~     central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed~     in autistic disorder suggest abnormalities in melatonin secretion.~      Several studies have reported a decrease in melatonin secretion in individuals with autism.~     Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin~     metabolite) was significantly negatively correlated with severity of autistic impairments in~     verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep~     problems and may play a role in the pathophysiology of autistic disorder.~      These data highlight the possible therapeutic interest of an oral administration of~     melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is~     to study the relation between the melatonin dose administered and its effect on severity of~     autistic impairments especially in verbal communication and play.~   "
97498|NCT01780870|"~     The main purpose of this study is to assess factors mediating the changes in insulin~     sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as~     well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.~      The investigators will also study the following:~        1. The impact of diet induced weight loss on hormones/adipokine levels~        2. The impact of diet induced weight loss on leptin tolerance~   "
97499|NCT01780857|"~     This study is being done to learn more about a less common type of psoriasis, called~     palmoplantar pustulosis (PPP). The majority of the current treatments used for this type of~     psoriasis have only a moderate effect on PPP. Thus, the investigators believe that PPP may~     be a different disease entity altogether, requiring different therapies. As such, the~     investigators hope to discover an immune signature for this condition.~      An immune signature is the unique way in which the combination of genes, cells, and~     proteins of the immune system work for each person. Because both psoriasis and the type of~     psoriasis patients have been diagnosed with, PPP, are conditions of abnormal immune system~     function, it is important to understand the overall function of the immune system in this~     condition (that is, find the immune signature). This study should help identify an immune~     system signature in people with PPP.~      The investigators have a laboratory technology which allows them to read the genetic~     signatures of a person's blood cells. Genes contain the instructions for making living~     things. Genes are contained in the cells' DNA (deoxyribonucleic acid). Most DNA is the same~     among humans, but the small differences people have in their DNA may explain why people~     develop different diseases. DNA and the genes it contains help produce RNA (ribonucleic~     acid), which in turn helps make proteins in people's cells. Differences in the types of~     proteins and the amount of those different proteins people's cells produce can affect a~     person's immune system.~      To help the investigators determine the immune signature in PPP, they will be examining~     the different genes, cells, and proteins that are active in patients with PPP versus~     patients who do not have the condition. The investigators will examine these genes, cells,~     and proteins in skin (through a skin sample) and in blood (through a blood draw). The goal~     is to develop new treatments for this skin condition. To do this, the investigators need to~     compare the skin and blood of patients with this particular type of psoriasis to the samples~     of healthy patients.~   "
97500|NCT01780844|"~     The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40~     monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.~     This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate~     mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care~     immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In~     addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus~     and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive~     regimen (basiliximab induction + tacrolimus + MMF + steroids).~   "
97501|NCT01780831|"~     This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (RAL) given to~     HIV-1-exposed newborn infants at risk of acquiring HIV-1 infection. (Pharmacokinetics are~     the various interactions between a drug and the body.) This study will also evaluate the~     appropriate dose of RAL to give to an infant to prevent the infant from getting HIV~     infection from its mother.~   "
97502|NCT01780818|"~     Water-aided method for colonoscopy can be broadly subdivided into two major categories.~     Water Immersion (WI), characterized by suction removal of the infused water predominantly~     during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by~     suction removal of infused water predominantly during the insertion phase of colonoscopy.~     Several studies showed that WE significantly reduces pain compared to WI and colonoscopy~     with traditional air insufflation (AI), increases the number of unsedated procedures and~     adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial~     will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test~     the hypothesis that WAC (particularly WE) would significantly decrease pain score during~     colonoscopy in average-risk screening patients. Several other secondary outcomes will also~     be analyzed.~   "
97504|NCT01780792|"~     Dance Dance Revolution (DDR) may offer an innovative and highly effective format for~     delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging~     and interactive video game that requires players to move their feet to targets while~     matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and~     cognitive training, is an ideal intervention for improving cognitive functioning in those~     with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly~     specific exercise intervention to improve mobility and cognition among individuals with MS.~   "
97505|NCT01780779|"~     The purpose of the study was to investigate whether functional MRI imaging (diffusion~     weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in~     children and young adults. All patients will be scanned before, during and after~     chemotherapy. The findings on MRI will be correlated with histological finding after~     surgery.~      Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.~      Third purpose : to try define prognostic factors, to investigate if there is a correlation~     between early treatment response and outcome.~   "
97506|NCT01780766|"~     Whole body MRI with diffusion weighted imaging is a useful imaging tool~        -  staging and diagnosis~        -  therapy monitoring All patients will be scanned before and during treatment. The~          findings on diffusion weighted imaging will be correlated to the golden standard~          (computer tomography and MRI (T1 and STIR)).~   "
97507|NCT01780753|"~     The weight of malaria falls most heavily on young children and pregnant women but studies of~     the safety of antimalarials in pregnancy and lactation are few. The only recommended~     medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria~     guidelines recommend its use in all patients with P.vivax infection in areas of low~     transmission, in the absence of contraindications. Primaquine is contraindicated in~     pregnancy. The postpartum period presents a key opportunity to definitively treat women who~     suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines~     allow for primaquine use during lactation but there are no studies to date quantifying~     primaquine excretion in breast milk and the dose that breastfed infants would be exposed to~     is unknown. The investigators propose to study the pharmacokinetics of primaquine in~     maternal and infant plasma and in breast milk during a 14 day radical treatment of P.vivax.~      Some inferences about the expected behavior of primaquine in lactation can be drawn from its~     known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in~     healthy subjects and malaria patients after single and multiple oral dosing. Peak~     concentrations are reached within 2-3 hours after dosing and the plasma elimination~     half-life is ~7 hours. It is extensively distributed in the tissue and largely metabolized~     to inert carboxyprimaquine, the major plasma metabolite, which undergoes further~     biotransformation to unknown metabolites that are probably more toxic than the parent~     compound. The identification of other metabolites in humans has been difficult to pursue~     because the expected aminophenol metabolites are unstable.~      No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A~     few studies have been done of other antimalarials during lactation and have shown low levels~     of drug in breast milk during treatment.~   "
97508|NCT01780740|"~     Patients with coronary artery disease are often prescribed drugs called statins because~     research has shown that, by lowering cholesterol, they reduce the risk of having a heart~     attack or other complications in the long-term. Experimental studies have suggested that~     statins may also have rapid anti-inflammatory, anti-oxidant and anti arrhythmic actions;~     however, whether these effects are of any benefit to patients remains to be proven. The~     purpose of STARR trial (Statin Therapy in Atrial Refractoriness and Reperfusion injury) is~     to evaluate whether a short course of a commonly used statin (atorvastatin, 80 mg once a~     day) decreases inflammation and stabilises electrical properties of the upper chamber of the~     heart in the post operative period of patients undergoing cardiac surgery on the heart-lung~     machine either for valve replacement and/or coronary artery bypass grafting. It will also~     examine whether this treatment can protect the heart from sustaining tissue damage when~     blood supply is restored after a period of ischaemia during the course of the surgery.In~     addition it will also explore the impact of this intervention on biology of the vessels used~     for bypass surgery and the fat tissue in the vicinity of the heart & blood vessels.~   "
97509|NCT01780727|"~     Elderly patients are the fastest growing surgical population and present with increased risk~     of postoperative cardiac problems, especially congestive heart failure. Diastolic~     dysfunction is common in the elderly population and increases the risk of major adverse~     cardiac events after surgery. This project will use dynamic measurements of diastolic~     filling pressures by echocardiography for goal-directed fluid and drug management during~     surgery to determine whether this reduces serious cardiac events related to diastolic~     dysfunction after surgery in this high-risk population.~   "
97510|NCT01780714|"~     The goal of this exploratory study is to evaluate the effect of a candidate modified risk~     tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and~     potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC).~     The subjective effects (urge to smoke and withdrawal symptoms) which are related to the use~     of this product will be explored. Initial information on safety and on some biological~     effects when using THS 2.1 will be collected. Human Smoking Topography (HST) will be~     explored.~   "
97511|NCT01780701|"~     A prostate cancer diagnosis starts a list of events that often leads to fast-moving~     treatment, thought by many to result in vast over-treatment of this disease. So, discovery~     of different diagnostic methods that allow clinicians to identify slow-growing from~     potentially fast-growing disease prior to or at the time of prostate biopsy could result in~     early and suitable treatment for men at greatest risk, while greatly decreasing the number~     of biopsies, surgical procedures, hormonal and chemotherapeutic treatments, cost, and~     patient worry, for those with more slow-growing disease.~   "
97512|NCT01780688|"~     The main goal of this exploratory study is to evaluate the pharmacokinetic profile of~     nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional~     cigarettes (CC).~   "
97513|NCT01780675|"~     Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard~     dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low.~     However, a clear relationship between radiation dose and damage to the hippocampal stem~     cells has not been established yet.~      This study is initiated to investigate the early and delayed neurotoxicity of PCI and to~     assess in a randomised design the benefits and risks of sparing the hippocampus in Small~     Cell Lung Cancer patients who receive PCI.~   "
97523|NCT01780545|"~     This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of~     Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense~     oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to~     docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma~     (UC) that are relapsed or refractory after receiving a platinum-containing regimen.~   "
97514|NCT01780662|"~     This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when~     given together with gemcitabine hydrochloride and to see how well they work in treating~     younger patients with Hodgkin lymphoma that has returned or does not respond to treatment.~     Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill~     them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more~     cancer cells.~   "
97515|NCT01780649|"~     Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic~     Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x~     magnification instead of 400x commonly used in ICSI. The purpose of this study is to~     evaluate the efficiency and the indications of IMSI through a multicentric randomised trial.~   "
97516|NCT01780636|"~     Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that~     presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying.~     The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown,~     but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous~     therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy,~     dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle.~     Unfortunately, responses to these treatments have been variable at best. Direct injection of~     botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating~     NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic~     nerve endings in the autonomic nervous system and has been used to weaken the puborectalis~     muscle in constipated patients.~      Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into~     the puborectalis muscle in women with NRPS. With use of this technique, we believe we will~     find that Botox injections decrease symptom severity and improve quality of life (QOL) in~     patients with NRPS.~      We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox~     injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox~     injection into the puborectalis muscle in patients with NRPS.~      All enrolled patients will receive ultrasound and EMG guided Botox injections at three~     points along the puborectalis muscle. Post-injection data will be obtained with a defecation~     diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional~     injections will be offered to patients who fail the initial treatment.~   "
97517|NCT01780623|"~     Cancer-related fatigue is one of the most common and distressing symptoms associated with a~     cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during~     treatment, and lasts for years after treatment in up to 35% of patients. Despite the~     long-term effects of cancer-related fatigue, the treatment options available are not always~     appropriate or helpful for all patients.Light therapy is an effective treatment for other~     disorders related to fatigue. The purpose of the study is to investigate the role of light~     therapy on quality of life, sleep patterns, and physical measures of immune function and~     stress hormones in individuals with post-treatment cancer-related fatigue.~   "
97518|NCT01780610|"~     There are two main cycle regimens used for endometrial preparation for frozen embryo~     transfer （FET) in women with irregular cycles: hormone replacement therapy cycles (HRT) in~     which the endometrium is artificially prepared by estrogen and progesterone hormones~     with/without a gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and~     ovulation induced cycles (OI) in which follicular development is supported with increasing~     doses of gonadotrophin hormones and ovulation is induced. At present, there is still no~     sufficient evidence that which kind of frozen embryo transfer cycle regimen to plan more~     advantage. The purpose of this study was to compare the pregnancy outcome of hormone~     replacement therapy cycles (HRT) and ovulation induced cycles (OI) in women with irregular~     cycles.~   "
97519|NCT01780597|"~     The main question to be asked in this study is what is the potential for human hearts that~     have been deemed unacceptable for transplant, to be explanted and re-animated in a~     controlled, external environment to be assessed? Furthermore would the reanimated hearts be~     able to undergo improvement in their function in this external environment.~      Ultimately this may lead to an increase the number of hearts available for transplantation.~   "
97520|NCT01780584|"~     Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill.~     This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary~     bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing~     Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation~     for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was~     known effective in maintaining T3 levels during pediatric cardiac surgery. This drug~     preparation however is not commonly used in many countries due to the relatively high costs~     and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3~     levels in pediatric patients has not been reported so far, although recent adult studies~     showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to~     determine if oral T3 supplementation could prevent the decline of serum T3 in children less~     than 2 years of age undergoing congenital heart surgery using CPB.~   "
97521|NCT01780571|"~     The purpose of this study is to determine whether continuouse positive airway pressure~     (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels~     of oxygen in the blood.~   "
97522|NCT01780558|"~     There are three main cycle regimens used for endometrial preparation for frozen embryo~     transfer（FET）: natural cycles (NC) with/without ovulation triggering, hormone replacement~     therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and~     progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down~     regulation, and ovulation induced cycles (OI) in which follicular development is supported~     with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there~     is still no sufficient evidence that which kind of FET cycle regimen to plan more advantage.~     The purpose of this study was to compare the pregnancy outcome of NC-FET to that of HRT-FET~     in women with regular cycles.~   "
97524|NCT01780532|"~     After locating the suspicious lesion/mass with standard of care mammography and/or~     ultrasound, a photoacoustic scan will be performed in the breast where the lesion is~     located. After the PA scan a biopsy will be performed, if clinically indicated (based on the~     mammogram and ultrasound only).~   "
97529|NCT01780467|"~     Use lay language.~      Many decisions involve the possibility of gaining or losing relative to the status quo. The~     loss aversion behaviour is a cognitive concept explaining that people are more sensitive to~     the possibility of losing objects or money than they are to the possibility of gaining the~     same objects or amounts of money.~      We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight~     this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary~     purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by~     comparing brain activity in parkinsonian patient with and without treatment with L Dopa,~     when they are exposed to mixed (gain/loss) gambles using money.~      The second purpose is to highlight the role of a dopamine depletion by comparing patient~     without treatment vs healthy paired control.~      2 groups :~        -  20 parkinsonian patients (tested two times : with and without treatment by L dopa)~        -  20 healthy paired control~      Description of the protocol for patients :~      J0 : Inclusion visit (duration : 4h):~        -  motor assessment (UPDRS)~        -  neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin~          scale, UPPS, MADRS, Hamilton, LARS).~      J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or~     without treatment) :~      Each acquisition was composed by an orientation sequence+ an anatomic sequence + a~     functional sequence.~      For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the~     MRI acquisitions.~   "
97530|NCT01780454|"~     This study will examine the safety and effectiveness of a combination kidney and bone marrow~     transplant from a haplo-identical related donor. An investigational medication and other~     treatments will be given prior to and after the transplant to help protect the transplanted~     kidney from being attacked by the body's immune system~   "
97531|NCT01780441|"~     The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous~     sclerosis complex (TSC) for a new study on early markers of autism. The study is looking for~     early signs for autism in a population (TSC) where autism is common. The goal of this~     project is to use behavioral testing, MRI and EEG techniques to identify children at risk~     for developing autism starting at 3 months of age and continuing until 36 months of age.~     Throughout the study, the investigators will recommend Early Intervention services for any~     child who shows early signs of autism.~   "
97532|NCT01780428|"~     This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of~     CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to~     severe pain following surgical removal of impacted third molar teeth.~      A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was~     included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also~     evaluated to placebo for the relief of pain.~   "
97533|NCT01780415|"~     The objective will focus on the characterization of DNA fragments present in Blastocoele~     fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic~     Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and~     -subsequently- Next Generation Sequencing and aCGH approaches will be used.~   "
97534|NCT01780402|"~     The purpose of this study is to test three hand feeding techniques that can be used to~     provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand~     feeding, and hand-under-hand feeding.~   "
97535|NCT01780389|"~     The current study examines the effects of milnacipran in patients who have chronic~     persistent knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for~     a pain-relieving effect.~   "
97536|NCT01780376|"~     Whole Body Vibration (WBV) applies thrust force in opposite direction to gravity to~     body.This mechanical stimulation induces reflex muscular activity. Tonic vibration reflex~     (TVR) is most commonly cited mechanism to explain WBV-induced reflex muscular activity~     (WBV-IRMA), although there is no conclusive evidence that TVR occurs. The bone myoregulation~     reflex is another neurologic mechanism used to explain the effects of vibration on muscular~     performance.~      Investigators hypothesized that latency of WBV-IRMA is different from latency of TVR.~     Primary aim of this study is to determine latency of WBV-IRMA. Secondary aim is to~     investigate whether WBV-IRMA is explained with TVR.~      Twenty healthy young adult men are planned to include in this study. Participants will stand~     upright with their knees locked during WBV. PowerPlate Pro5 will be used for WBV. WBV with~     high amplitude at 25,30,35,40,45 and 50 Hz will be applied. Surface electrodes will be~     placed on both the soleus muscles. To measure TVR latency, piezo-electric accelerometer will~     be placed on the achilles tendon and this achilles tendon will be stimulated with spring~     based mechanical reflex hammer. Our pilot study was showed that motor unit potentials (MUAP)~     occurred in a 1:1 response with vibration. After confirmation of this finding, WBV-IRMA~     latency will be measured in the present study. To measure WBV-IRMA latency, piezo-electric~     force sensor will be placed between heel and WBV platform. Exact moment of initial strike of~     heel when thrust force expressed by WBV begin to be transferred to body will be determined.~     The time between moment of the initial strike and corresponding MUAP is defined as WBV-IRMA~     latency. Piezo-electric stretch sensor will be placed between knee and malleol to simulate~     muscle spindle. The reflex muscle activity of soleus muscles will be measured by PowerLab~     (data acquisition system, ADInstruments, Australia) device.~      This project is planed to be completed in 1 months.~   "
97537|NCT01780363|"~     Background: Genetics is suggested to play a critical role in the development of Behçet's~     disease (BD). Shared phenotypic features requires an approach to the differential diagnosis~     from periodic febrile syndromes particularly from mevalonate kinase deficiency related~     diseases. We planned to study for evaluating the frequency of mutations and their clinical~     significance in mevalonate kinase gene in Turkish patients with Behçet's disease.~   "
97538|NCT01780350|"~     This study is attached to a comprehensive quality assurance/quality improvement (QA/QI)~     program conducted by the Office of the medical director, and is designed to contribute to~     generalizable knowledge to determine effectiveness and tolerability of an FDA approved~     Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS)~     system. The cohort will comprise a convenience sample of patients that are being treated by~     EMS for a hypotensive emergency.~   "
97539|NCT01780337|"~     In this pilot study the investigators will perform a double-blind randomized trial of~     intranasal oxytocin on measures of cardiac refractoriness, among individuals who are~     undergoing clinically indicated catheter ablation procedures for paroxysmal atrial~     fibrillation. The investigators seek to enroll 20 patients for this study, for the purpose~     of estimating effect sizes for a larger future study.~   "
97622|NCT01779245|"~     A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this~     may be due to a shift in substrate metabolism where there is an increase in the rate of fat~     oxidation. However, whether high-calcium intake can influence substrate metabolism during~     exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of~     high-calcium intake on substrate metabolism during exercise.~   "
97540|NCT01780324|"~     Primary Aim~      1. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC)~     Pain Scale score at the time of transurethral bladder catheterization for urine collection~     in children who do and do not receive intraurethral 2% lidocaine jelly prior to~     catheterization.~      Secondary Aims~        1. To assess gender differences in pain control during transurethral bladder~          catheterization with and without pain control using intraurethral 2% lidocaine jelly.~        2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.~           To assess parental impression of discomfort between intervention and control groups.~        3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.~        4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the~          time of TUBC for urine collection in children who do and do not receive intraurethral~          2% lidocaine jelly prior to catheterization.~   "
97541|NCT01780311|"~     A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs~     for outflow tract ventricular arrhythmias~   "
97542|NCT01780298|"~     Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway~     affecting approximately 10% of individuals aged 40 years or more with a smoking history. The~     disease is characterized by an increase in numbers of airway white blood cells (neutrophils,~     lymphocytes and monocytes). Stimulation of white blood cells results in the release of~     different agents of inflammation. Some of these agents give an indication of the presence or~     severity of a disease when measured.~      This case control study will be conducted at The Heart Lung Centre, London, UK. The study~     aims to determine biomarkers for the differentiation of subjects with COPD (GOLD Stage 1-2~     and who are current smokers with a ≥ 10 pack year smoking history) and three matched control~     groups: one of non-smoking subjects (never smoked), one of ex-smokers and one of current~     smokers. COPD subjects will be matched to the non-COPD subjects by gender, age and~     ethnicity.~      The study will include a range of physiological measurements including lung function,~     computerized tomography scans (CT scans), cardio pulmonary exercise test and computerized~     multichannel lung sounds analysis (Stethographics). In addition, lung inflammation will be~     assessed by cellular and molecular biomarkers using e.g. transcriptomics and proteomics~     technologies.~   "
97543|NCT01780285|"~     This study is prospective randomized trial enrolling at least 50 participants which compares~     efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e.~     with hiatal surface area (HSA) exceeding 20 sq.cm) types II and III hiatal hernias:~     partially absorbable lightweight mesh repair, and nitinol-framed lightweight~     polytetrafluoroethylene (PTFE) mesh repair. In the literature, mean rate of anatomical~     recurrence of giant hiatal hernias is 25 %, reaching 42 %. Polypropylene and composite PTFE~     meshes used most widely, result in unacceptable rates of long-term dysphagia (10-15 %) and~     oesophageal strictures. Own experience of the interventors of more than 400 repairs using~     partially absorbable lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of~     its fixation precluding contact of the mesh with the oesophagus, showed low recurrence rate~     for large hernias and a few cases of long-term dysphagia. For giant hiatal hernias, this~     technique provides acceptable results (20 % of recurrence) which correspond to the~     literature. Nevertheless, these results may be improved, probably by using of new type of~     prosthesis. Thus, in collaboration with Minnesota Medical Development, Inc., USA, the~     interventors created fundamentally new method of hiatal repair by using new prosthesis -~     Rebound HRD-Hiatus hernia. This prosthesis is heart-shaped lightweight PTFE mesh with~     peripheral nitinol frame. It is easily fixated to the crura posteriorly to the oesophagus~     completely covering hernia defect, and supports a strong framework of the hiatus, and,~     therefore, allows to save a principle a real tension-free repair. Mid-term results (mean~     follow-up period of 15 months) of 29 procedures showed no recurrences or oesophageal~     complications. Naturally, final conclusions regarding superiority of the new technique could~     be established by prospective randomized study. The hypothesis of the current trial is: new~     method of nitinol-framed lightweight PTFE mesh repair is more effective in terms of~     recurrence rate compared to sub-lay partially absorbable lightweight mesh repair, and is~     characterized by at least similar safety in terms of oesophageal complications. The~     long-term results (24 months post surgery for every patient) will be studied using symptom~     questionnaires, quality of life and satisfaction questionnaires, barium studies, endoscopic~     examinations, 24-hour pH testing, and analysis of possible reoperations.~   "
97544|NCT01780272|"~     This trial is conducted in Europe. The aim of this trial is to investigate the impact of low~     blood sugar during the night on sleep in subjects with type 2 diabetes.~   "
97545|NCT01780259|"~     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to~     the medication) of intranasally (through the nose) administered esketamine in healthy~     participants.~   "
97546|NCT01780246|"~     This study will test the safety and tolerability of ISIS-SMNRx administered into the spinal~     fluid as a single injection in patients with Spinal Muscular Atrophy, who previously~     participated in ISIS 396443-CS1~   "
97547|NCT01780233|"~     The objective of this study was to compare the rate of absorption and bioavailability of~     fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate~     injection 100 µg intravenously.~   "
97548|NCT01780220|"~     As there is no prospective data on the combination of abiraterone and salvage radiotherapy,~     the aim of this study is to further evaluate the safety profile of abiraterone acetate plus~     prednisone in patients with prostate cancer who are biochemically relapsing after surgery~     and undergo salvage radiotherapy with 6-months LH-RH agonist.~      The investigators hypothesize that the toxicity profile of both treatments should not~     potentiate each other. This study will also provide preliminary data on the efficacy of this~     combination.~   "
97549|NCT01780207|"~     The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant~     patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal~     hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function~     and arterial stiffness.~   "
97550|NCT01780194|"~     -  To determine the effect size of lumbar fusion measured by Oswestry Disability Index and~          compared with conservative treatment in patients with chronic low back pain.~        -  Meta-analysis using fixed effect model synthesis method.~        -  Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.~   "
97551|NCT01780181|"~     The purpose of this study is to observe the efficacy of chemotherapy combined with~     Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer,~     also to evaluate the adverse reaction and the reliability.~   "
97623|NCT01779232|"~     The purpose of this study is to determine whether pre-treatment with danazol for at least 4~     months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.~   "
97552|NCT01780168|"~     Background:~      - Inborn errors of metabolism (IEM) can affect how the body s immune system functions.~     People with IEM also have special dietary restrictions that may affect the function of their~     immune system. Researchers want to better understand how having an IEM may affect immune~     system function.~      Objectives:~      - To study the how having an IEM may affect immune system functioning.~      Eligibility:~        -  Individuals at least 2 years of age who have an IEM.~        -  Healthy volunteers at least 2 years of age.~      Design:~        -  Participants will come to the NIH Clinical Center for at least 1 evaluation. Depending~          on the level of participation, participants may return for additional visits. All~          participants (or their parents) must keep a detailed food diary for 3 days before the~          initial visit.~        -  At the study visit, participants will provide blood samples. Females of childbearing~          age will provide a urine sample.~        -  Participants will be offered the hepatitis A vaccination if not already given. If the~          visit occurs during flu season (roughly September through March), they will be offered~          a seasonal/H1N1 influenza vaccine.~        -  Children between 2 and 8 years of age may require booster shots depending on their~          history of vaccination.~        -  At a follow-up visit(s), participants will provide additional blood samples.~        -  Participants may return yearly for their flu vaccine.~   "
97553|NCT01780155|"~     Background:~      - Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of~     prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes,~     respectively. BPD is associated with receiving mechanical ventilation to treat respiratory~     distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor~     development of blood vessels in the eyes, and may lead to blindness. Because not all~     premature babies develop BPD or ROP, researchers want to study the genes that could be~     associated with these diseases. They will look at both premature infants and their parents~     to see if there is a genetic component to BPD and ROP.~      Objectives:~      - To study genes that may be associated with BPD and ROP.~      Eligibility:~        -  Premature babies born with a weight less than or equal to 1,250 grams.~        -  Parents of the premature babies.~      Design:~        -  Parents will answer questions about the mother s health and pregnancy.~        -  Delivery and medical information will be collected during the baby s hospitalization~          for the first month after birth.~        -  Parents will provide a saliva sample from the inside of the cheek.~        -  A saliva sample will also be collected from the baby within 28 days of birth. If the~          baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid~          samples will also be collected.~        -  Parents will have followup interviews about their child s health 6 months, 12 months,~          and yearly for up to 6 years after birth.~        -  This is a genetic study only. Treatment will not be provided as part of this study.~   "
97554|NCT01780142|"~     Background:~      - Asthma is a lung condition that causes difficulty breathing and decreased lung function.~     Some people with asthma have more severe disease symptoms. They may be less responsive to~     standard treatments such as steroids. Researchers want to compare severe asthmatics with~     mild or moderate asthmatics or people without asthma over a long period. This information~     may help identify new treatments for people whose asthma is not well controlled by standard~     medications.~      Objectives:~      - To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to~     study the progression and outcomes of the disease.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with asthma for at least 1~          year.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study will involve an initial visit to the NIH Clinical Center for all~          participants. Selected participants may be asked to return for repeat visits over a~          number of years. The test results from participants with asthma will be compared with~          those from the healthy volunteers.~        -  All participants will be screened with a physical exam and medical history.~        -  Participants may (but will not necessarily) have the following tests at each visit:~        -  Complete medical history and physical exam~        -  Blood, urine, sputum, and nasal cell samples~        -  Breath tests and heart and lung function tests~        -  Six-minute walk test to measure ability to exercise~        -  Imaging studies such as chest x-rays, bone density scans, and sinus scans~        -  Allergy skin testing~        -  Vocal cord exam~        -  Overnight sleep study~        -  Participants may remain on the study for as long as they are willing to participate and~          do not develop health problems that will interfere with the study.~   "
97555|NCT01780129|"~     HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac~     function, improves microcirculation, and increases blood pressure and pulse pressure, and~     improves blood perfusion of important organs; HW6's anti-shock activity comes from a~     combined multiple target pharmacological effects.~      Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock~     patient.~      This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin~     Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with~     traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with~     systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure~     stabilization, regardless the types of completed, on-going, or projected Standard of Care or~     surgery will be recruited to participant in the trial. A total of 120 patients with~     traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each~     type of shock, sixty patients each will be in test group and control group. Both adult males~     and females aged 18-80 years are eligible. The primary clinical endpoint is the time length~     (TL) between the start of HW6 administration to the onset of the first treatment success,~     that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour~     without the use of vasopressors. Several secondary endpoints and biomarkers will be~     measured.~      Efficacy data will be compared using group t-test or Wilcoxon log-rank test between~     treatment groups and placebo groups. Safety data will also be reported accordingly.~   "
97556|NCT01780116|"~     When compared with those in the control (usual care) group, participants in the AT group are~     expected to demonstrate significant improvements immediately and at three, six and 12 months~     after completion of the intervention in: level of medication adherence, readmission rate,~     mental status, insight into treatment, and level of functioning.~   "
97557|NCT01780103|"~     In this retrospective study the investigators will enroll newborns that were born between~     01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of~     Pyelectasis according to prenatal sonographic screening test.~      These babies underwent renal sonography at the age of 2-5 days according to the protocol and~     were invited to an additional renal sonographic screening test at the age of 1 month.~      The investigators will compare the results of the 2 examinations and the investigators will~     try to reach conclusions whether there is correspondence between the severity of the~     pyelectasis in the first and second sonographic tests and the outcome of these newborn~     babies~   "
97558|NCT01780090|"~     The proposed study will result in a software application compatible with the Apple iPad,~     iPhone and iPod Touch (hereafter termed iOS devices) which addresses several aspects of~     prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other~     communication disorders, using a developmentally appropriate, intuitive interface that~     requires little technical skill and which can be managed by educators and parents. The~     program will contain elements that aid in tracking and maintaining individual student~     progress records, and will be designed for use in the classroom, at home, and in other~     environments. This study's intended focus is on the feasibility and usability of the~     software application.~   "
97559|NCT01780077|"~     The purpose of this trial is to evaluate the safety and tolerability of multiple (3)~     intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy~     volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be~     evaluated visually, histologically, and by biomarker analysis.~   "
97560|NCT01780064|"~     The purpose of this study is to compare the effect of early individualized psychosocial~     assets versus a standard support on social inequalities in the rate of return to work~   "
97561|NCT01780051|"~     This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover~     study. The objective of the study is to compare the pharmacokinetic properties after~     co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration~     of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50~     healthy male volunteers.~   "
97562|NCT01780038|"~     Innovative strategies to reduce adult smoking prevalence include using genetic information~     to motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these~     interventions depends, in part, on smokers' interest and participation in genetic testing~     related to cessation and their understanding and use of the results (i.e., their genetic~     literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine~     receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it~     highly feasible to investigate smokers' interest in and use of genetic information about~     nicotine dependence. Therefore, the primary purpose of this study is to determine the impact~     of an intervention that provides smokers with an educational session about genetic~     contributions to smoking and nicotine dependence plus their genotype results for rs1051730~     on smoking cessation outcomes compared to those who receive only the educational session.~     Secondary purposes are to determine: (a) the impact of genetic education and knowing~     personal genotype results on genetic literacy outcomes and (b) the feasibility of~     recruitment and retention methods in a study addressing genotyping for nicotine dependence.~     Primary outcomes are cessation-related behaviors and cognitions indicating abstinence.~     Secondary outcomes are cognitions and emotions indicating genetic literacy. Knowledge gained~     from this study has the potential for clinical translation so that as genotyping becomes~     part of smoking cessation, health-care providers can understand and address factors~     influencing smokers' adaptation to genetically-informed cessation treatment. The study will~     use a longitudinal, repeated measures design (experimental, control; N=90; 45/group). All~     participants will receive a 90-minute educational session about genetic contributions for~     smoking and nicotine dependence and will donate a buccal swab sample for genotyping. The~     investigators will then randomize participants to two groups: those who receive genotyping~     results in a genetic counseling session (experimental) and those who do not (control).~     Follow-up data will be collected from both groups at baseline and weeks 2, 6, 10 after the~     experimental group receives genotyping results, with a brief follow-up and study termination~     occurring at week 12. Control group participants will be offered their genotyping results at~     the end of the study.~   "
97563|NCT01780025|"~     The purpose of this study is to measure objectively the coupling from direct acoustic~     cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked~     potentials.~   "
97564|NCT01780012|"~     Osteoporosis is a disease characterized by reduced bone mass and increased skeletal~     fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture~     is a powerful predictor of future fractures and about 50% of patients with a fragility~     fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007).~     Osteoporotic fractures are associated with an increased morbidity and mortality but also~     high financial costs. However, less than 20% of patients presenting a low trauma fracture~     receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The~     hypothesis of a lack of information and an under assessment of consequences by both patients~     and physicians has been raised to explain this gap between recommended care and usual~     practices.~      The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis~     prevention program, after a fragility fracture of the upper limb, to improve post-fracture~     management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50~     years old.~      This open randomized controlled trial aims to compare the BMD or osteoporosis treatment~     prescription rate at 6 months after inclusion between two groups: intervention receiving~     information on fracture and osteoporosis (oral and written), phone call reminders and~     written information to give to their family physician, and control receiving usual care~     without information.~   "
97565|NCT01779999|"~     Background: PICC-related thrombosis have shown a slightly different pattern of frequency and~     risk factors, compared with traditional CVC; because of the increasing diffusion of PICCs,~     they are becoming a somehow independent pathology, still under investigation; no~     pharmacological prevention has proved to be effective. Aim of this study is to estimate the~     cumulative incidence of thrombosis in a cohort of patients carrying a PICC-line CVC,~     monitored to allow an early detection and prevention of complications related to the~     presence of asymptomatic deep venous thrombosis, and to explore the role of several~     potential risk factors.~      Methods: in a prospective observational cohort we will enroll 150 consecutive patients~     having a PICC inserted by our team; clinical characteristics, comorbidities and main~     features of catheter positioning procedure will be registered; patients will be followed~     with clinical and echographic scheduled controls, weekly for the first month, then monthly;~     patients with PRDVT will be treated with LMWH and recontrolled weekly until removal of~     catheter~   "
97566|NCT01779986|"~     The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as~     evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and~     convention coronary angiogram results in patients who are scheduled for an ascending aorta~     aneurysm reparation surgery. These examens are standard of care before this surgery, so~     there is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS~     is a reliable screening test for CAD in patient undergoing heart surgery for other reason~     than CAD.~   "
97567|NCT01779973|"~     The goal of this project is to test the feasibility, acceptability, and preliminary efficacy~     of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate~     dependence. To that end, 10 opiate dependent subjects will be recruited through the~     University of Pennsylvania's Treatment Research Center, an outpatient substance abuse~     treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted~     as needed according to individual requirements).~   "
97568|NCT01779960|"~     Up to this moment, the majority of studies assessing the level of physical activity in daily~     life in patients with COPD are limited to a cross-sectional design, which does not take into~     account natural variation of physical activity in daily life due to differences in climatic~     conditions faced throughout the year. Preliminary evidences suggest that patients with COPD~     have different physical activity levels according to the seasons of the year. However, the~     limited current evidences do not allow us to know the magnitude of differences in the level~     of daily physical activity in patients with COPD when taking into account climatic changes~     resulting from different seasons of the year in cities and countries with contrasting~     climatic conditions. This gap observed in the literature does not allow us at this moment to~     know whether we should or not consider the season of the year as one of the main causes of~     variability while assessing physical activity in daily life in patients with COPD.~      The present project proposes to investigate the hypothesis that patients with COPD who live~     in a place with less marked decrease in temperature between summer and winter (Londrina,~     Brazil) have less variability in the level of physical activity in daily life through the~     year in comparison to patients who live in a place with more marked climatic variability~     during these seasons (Leuven, Belgium).~   "
97569|NCT01779947|"~     The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal~     Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the~     efficacy of each of the 2 active treatments is superior to that of the placebo.~   "
97570|NCT01779921|"~     This study is conducted globally. The aim of this study is to describe the treatment~     modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with~     factor VII (FVII) deficiency in addition to evaluate the presence (in already treated~     patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related~     thrombosis.~      Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use~     (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII~     (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation~     Registry (STER, NCT01269138). These patients can also have been treated with other~     haemostatics for systemic administration.~   "
97571|NCT01779908|"~     Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in~     130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants~     will have abdominal obesity and at least one factor associated with insulin resistance.~     Participants will be randomized by sex, BMI and age. The primary aim is to compare the~     effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin~     sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp).~     Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of~     glucose metabolism, the lipid profile, blood pressure and anthropometric measurements.~     Questionnaires on physical activity and sunlight exposure, and a food frequency~     questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and~     6 mo, changes in serum 25(OH)D will be correlated with changes in blood markers associated~     with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin,~     leptin, total and undercarboxylated osteocalcin].~      This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency~     plays a causal role in the pathogenesis of insulin resistance in humans; and (2) that~     vitamin D increases insulin sensitivity.~   "
97572|NCT01779895|"~     The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the~     quality of life in adult subjects suffering from perennial allergic rhinit.~   "
97573|NCT01779882|"~     The aim of this study is to test the hypothesis, that the order of application of Busulfan~     (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem~     cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.~   "
97574|NCT01779869|"~     The objective for this pilot study is to develop an optimized, clinically usable myocardial~     PET-MR perfusion protocol and to determine which of all data potentially available should be~     acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that~     high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion~     imaging, significantly decreasing examination time and patient radiation dose while~     maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.~      The primary outcome will be comparison of diagnostic accuracy of each combination of imaging~     to detect clinically significant coronary artery stenosis (≥70% diameter stenosis). The~     secondary outcome will be comparison of confidence for presence of disease among data sets.~   "
97575|NCT01779856|"~     The primary objective of this study is to estimate the proportion of hemodialysis patients~     experiencing clinically significant cardiac arrhythmias over a 6-month period using~     continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor~     (ICM) device.~   "
97576|NCT01779843|"~     This research study is a Phase I clinical trial. Phase I trials test the safety of an~     investigational drug or combination of drugs. Phase I studies also try to define the~     appropriate dose of the investigational drug to use for further studies. Investigational~     means that the combination of drugs is still being studied and that research doctors are~     trying to find out more about it. As part of this research study, you will take alisertib in~     combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for~     your cancer. However, cytarabine and idarubicin have both been approved by the FDA for~     treatment of AML. It also means that the FDA has not approved giving alisertib with~     idarubicin and cytarabine for use in patients, including patients with your type of cancer.~      Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat~     individuals diagnosed with AML. Alisertib has been used in laboratory studies and those~     studies suggest that alisertib may slow down the spread of your cancer. It does this by~     blocking certain substances needed by the cancer cells to spread. In this study, researchers~     would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in~     order to see if it can be given safely with chemotherapy in individuals with AML.~      The primary purpose of this research study is to determine the highest dose that alisertib~     can be given with idarubicin and cytarabine without severe or unmanageable side effects. The~     dose identified in this study will be used in future research studies.~   "
97578|NCT01779817|"~     1. MAIN OBJECTIVE :~           To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual~          development of the child from 6 to 9 years~        2. SECONDARY OBJECTIVES :~             1. To assess the consequences of a maternal hyperthyroïd during pregnancy on the~               capacities of attention, learning process and the degree of hyperactivity of the~               child from 6 to 9 years.~             2. To study if it exist differences of intellectual development, capacities of~               attention, learning process, and degree of hyperactivity in the child from 6 to 9~               years, born to hyperthyroid mother during pregnancy, according to:~                  -  the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid~                    versus disease of Basedow),~                  -  the use or not of a anti-thyroid treatment,~                  -  the rate of TSH néonatal (measured with the blotter by tracking with J3 at~                    all the new born ones).~   "
97579|NCT01779804|"~     Foot and ankle injuries account for nearly two million visits to Emergency Departments (EDs)~     in the United States and Canada each year. Of these injured patients, only 15% are diagnosed~     with actual fractures of the ankle. Due to such a small percentage, the Ottawa Ankle and~     Foot Rules (OFAR) were developed, which are a set of clinical decision-making guidelines~     that have been shown to be effective in diagnosing ankle and foot fractures. These rules are~     internationally accepted by the medical community, but are inconsistently applied.~      At Lehigh Valley Health Network (LVHN), the ED triage nurses are routinely trained in how to~     use the Ottawa Ankle and Foot Rules, but the rules are not always applied which may result~     in unnecessary X-rays. These guidelines are current network standard of care (usual,~     established care) that allow nurses to decide treatment for foot and ankle injury patients;~     in other words, whether to send these patients for an X-ray or not.~      The research staff is conducting this study in order to find out if using these~     nurse-directed guidelines--on a regular and consistent basis--can decrease the number of~     X-rays ordered, decrease patient waiting times/length of stay (LOS) and increase patient~     satisfaction with their care in the ED.~      STUDY PURPOSE:~      The two main goals of this study are to find out if use of the Ottawa Ankle and Foot Rules~     by triage nurses can decrease the amount of X-rays ordered in the ED, as well as LOS.~      Secondary study goals are to: 1) see how many X-rays are ordered by physicians and~     physicians' assistants after patients are evaluated by the Ottawa Ankle and Foot Rules as~     not having had a fracture; and 2) evaluate patient and provider satisfaction with the care~     provided both when the Ottawa Foot and Ankle Rules are used and when they are not.~   "
97580|NCT01779791|"~     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)~     administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).~   "
97581|NCT01779778|"~     The purpose of this research study is to determine the diurnal and nocturnal effects of~     Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.~   "
97582|NCT01779765|"~     This study objective is to assess the short and long term effects of partially hydrolyzed~     guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these~     patients.~   "
97583|NCT01779752|"~     In human, the cerebral cortex forms a network of vestibular cortical areas which functional~     role remains unknown. In patients with localised cortical lesions the investigator has~     previously demonstrated that the parieto-temporal cortex could regulate the inertial~     component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the~     temporo-occipital cortex would be associated with gain regulation of these VOR responses.~      The investigator's main purpose is to investigate the modalities of vestibular integration~     in these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using~     repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a~     transitory inhibition of one of these 2 cortical regions and register its effect on VOR~     responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate~     the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec.~     Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation,~     the investigator will record the subject's VOR responses. The VOR gain will be calculated~     and the time constant and phase will provide an estimation of the inertial component of the~     VOR responses. The healthy subjects recruited on the basis of inclusion criteria during~     medical examination will be divided into two groups of 20 subjects each depending of their~     sites of stimulation, temporo-parietal or temporo-occipital. Each subject will perform three~     experimental sessions (of 1h in average each) separated by at least one week and~     corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the~     vertex stimulation serving as the control session.~      The TMS paradigm is used in routine in hospital and research field and had very few negative~     consequences (mainly transitory and occasional headache).~   "
97584|NCT01779739|"~     This is a single center, double-blind, randomized controlled trial evaluating the change in~     sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants~     will be sexually active women who agree to randomization to having perineorrhaphy added to~     or excluded from their surgical repair. We hypothesize that sexual function will improve~     more significantly in women undergoing vaginal repair with perineorrhaphy.~   "
97585|NCT01779726|"~     Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease~     is an important prognostic factor as an advanced stage reduces the opportunity for surgical~     intervention and other curative treatment. In denmark, as in many other countries, a fast~     track evaluation for lung cancer has been introduced in 2008.~      When the general practitioners refer patients through the fast track, the majority of~     patients make their first visit to the Department of Pulmonary Medicine. After this visit,~     further investigation is initiated, which is often a CT scan of the chest and the upper~     abdomen. We dont know Whether this is the most appropriate organisation.~      The aim of this project is to evaluate the way lung cancer patients are examined through the~     fast track and the impact of chest CT before an evaluation by a chest physician.~      Investigators want to randomise all patients referred for the existing fast track to either~     direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order~     to test:~      A) Fast track performance measured by number of CT scans and chest physician specialist time~     per diagnosis, and whether there is a difference between the intervention and the control~     group.~   "
97597|NCT01779570|"~     Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and~     mortality worldwide. While viral replication can be suppressed by antiviral treatment,~     excessive inflammatory responses, which are increasingly recognized to contribute to severe~     influenza complications, remain unopposed. Macrolides have been used widely to treat~     community-acquired pneumonia, and shown to exert anti-inflammatory effects in other~     respiratory diseases, providing clinical benefits. In this randomized, open-label,~     multicenter study, we aim to investigate the anti-inflammatory effects of macrolide~     treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms~     and disease resolution will be studied. Such results may lead to the development of new~     therapeutic approaches against severe influenza infection, and provide better insights into~     disease pathogenesis.~   "
97586|NCT01779713|"~     Rational: The main danger with intracranial aneurism is its rupture conjugated with~     subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to~     neurological but also extra cerebral disorders. The major cause of morbidity and mortality~     when developing a SAH is the secondary development of a delayed cerebral ischemia~     consecutive to a prolonged vasospasm of cerebral arteries. The understanding of the~     pathophysiological mechanisms of SAH complication, such as vasospasm which is the more~     frequent, is essential.~      Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the~     subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a~     vasospasm could have a huge clinical impact leading to delayed neurological ischemic~     deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence~     are not well described.~      Disposing of well-established genetics and transcriptomics databases along with cerebral~     ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm~     occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology~     and elaborate an efficient and individualized therapeutic strategy to SAH acute phase in~     order to reduce the risk of vasospasm occurrence.~      Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a~     database grouping clinical and biological data 3) Look for genetic and transcriptomic early~     markers via genomic approaches 4) Correlate these different markers with vasospasm~     occurrence and clinical evolution of the patients~      Study: Patients inclusion will be done following their admission (D1) in the  unité de~     réanimation neurochirurgicale of Pitié-Salpètrière Hospital. After obtaining of the~     informed consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube~     for the transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and~     biological follow-up will be performed as usual.~      200 patients will be initially included during 2 to 3 years for the transcriptomic study of~     which 1/3 will develop vasospastic complication. The transcriptomic study will thus be~     performed by comparing patients developing or not developing this complication~      Expected Results: Unravel vasospasm early genetic markers.~   "
97587|NCT01779700|"~     This will be a single site safety and proof of concept study conducted at the Indiana~     University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective~     disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched~     placebo for duration of 8 weeks.~   "
97588|NCT01779687|"~     Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the~     increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma~     low-density lipoprotein (LDL) cholesterol levels and is used for prevention of~     artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the~     preferred antiretroviral agents in HIV patients with dyslipidemia because it has a~     beneficial lipid profile.~      Theoretically, no clinically relevant drug interaction is expected between atorvastatin and~     raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which~     could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to~     recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy~     volunteers is proposed.~   "
97589|NCT01779674|"~     This study´s aim is to collect scientific data about patients with atrial inflammation by~     two principles of sensors measuring congestive heart failure.~   "
97590|NCT01779661|"~     The objective of this research is to examine the effect of Infant Aquatics on the~     development of and neurodevelopment of preterm and near-term infants, using the GM as~     prognostic estimation of future development.~      Preterm infants, a continuously growing population, are at high risk for neurodevelopment~     impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly~     due to developmental brain injury. Infant Aquatics have been found to benefit and promote~     infant development. The support and sensory stimulation of the water may improve the~     development the sensory, motor, as well as, autonomic system of preterm infants.~      The study will compare intervention by Infant Aquatics to infant massage. The intervention~     in both methods will start at 36 weeks gestational age for 3 months and will consist of~     sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8~     and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland~     adaptive behavior scales.~   "
97591|NCT01779648|"~     Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of~     compression have been developed and used for prevention of deep vein thrombosis.~      There are still some controversies about the physiologic properties and clinical impact of~     numerous issues including the variety of the cuff length, inflation rate, compression~     sequence, compression-relaxation cycle rate, and pressure generation characteristics.~      This study is designed to compare clinical efficacies as well as venous hemodynamic~     improvements between Simultaneous bilateral compression with fixed venous refill time versus~     alternate compression with adjusted refill time~   "
97592|NCT01779635|"~     The investigators hypothesize that the use of heparin-grafted membrane versus conventional~     membrane in critically-ill patients with bleeding-risk undergoing continuous renal~     replacement therapy, will effectively prolong the circuit lifespan, without worsening of the~     systemic APTT or underlying bleeding risk.~   "
97593|NCT01779622|"~     To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin~     hormone secretion in healthy volunteers~   "
97594|NCT01779609|"~     The purpose of this study is to establish the effect of ET blockade on vascular adaptations~     during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET -~     blockade with exercise training leads to an acute increase of exercise induced blood flow~     when compared with exercise alone. We expect that this will lead to an optimization of~     vascular training effect in T2DM.~   "
97595|NCT01779596|"~     The purpose of this study is to establish the effect of ET blockade on the acute exercise~     induced blood flow and endothelial function in subjects with T2DM. We hypothesize that~     combining ET - blockade with exercise training leads to an acute increase of exercise~     induced blood flow when compared with exercise alone. We expect that this will lead to an~     optimization of vascular training effect in T2DM.~   "
97596|NCT01779583|"~     Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies~     (MVBs), and are released into the environment by fusion of the MVBs with the plasma~     membrane. It has been demonstrated that the content and function of exosomes depends on the~     originating cell and the conditions under which they are produced. Tumor exosome production,~     transfer and education of bone marrow cells supports tumor growth and metastasis.~      In this prospective translational study, preclinical and clinical phases have been designed.~     On the first step, the main goal is to characterize the molecular profile of gastric cancer~     derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a~     second step, the study will evaluate the prognostic and predictive value of gastric cancer~     exosomes levels in plasma and kinetics in a prospectively recruited cohort of advanced~     gastric cancer patients during first-line chemotherapy.~   "
97598|NCT01779557|"~     This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and~     Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.~   "
97599|NCT01779544|"~     Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as~     endurance, strength, stretching and information. Evidence concludes that it is not harmful~     to return to activity after lumbar disc surgery, and restrictions to activities after these~     operations are today more or less nonexistent. Some studies have shown that high intensity~     programs might be more effective, but they are probably more expensive. In recent years~     cognitive interventions have received more attention in rehabilitation programs after lumbar~     disc surgery. The cognitive approach is focused on providing patient knowledge to reduce~     uncertainty so that he or she can understand what is important after lumbar disc surgery so~     that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient~     to resume normal activities. Reviews ask for how much treatment are needed in a~     rehabilitation program after lumbar disc surgery.~      The study will be a randomized clinical trial. The study will compare two different~     post-operative rehabilitation programs (general information or general information +~     exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in~     exercise therapy group are supposed to continue with exercises 3 months.~      In this study the following hypothesis will be studied:~        1. Brief intervention, an educational model, alone after lumbar disc surgery do have the~          same effect on pain in legs and low back as brief intervention, an educational model,~          combined with exercise therapy.~        2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program,~          are being done by the patients.~   "
97600|NCT01779531|"~     Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer~     patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol~     neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete~     response(pCR) are randomly divided into the group treated with XT protocol and the group~     with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare~     the disease free survival(DFS) and overall survival(OS) of two subgroup.~   "
97601|NCT01779518|"~     This is a single arm, open-label study which will be opened at specific clinical sites at~     the request of an investigator for the treatment of individual subjects for whom there are~     no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD)~     with RBV; pegylated interferon may be added at the discretion of the investigator.~   "
97602|NCT01779505|"~     This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020)~     in various doses and dosing regimens in healthy adults at one center in the US. Subjects~     will be enrolled into 3 arms using a dose escalation scheme and randomized into one of two~     dosing regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to~     achieve 48 evaluable subjects enrolled), with study completion in 9-12 months.~   "
97603|NCT01779492|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.~   "
97604|NCT01779479|"~     Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes~     microtubules against cold-induced depolymerization as efficiently as docetaxel and was~     selected for development based on a better antiproliferative activity on resistant cell~     lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus~     prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients~     leading to registration of the compound. It showed a favorable toxicity profile with an~     interestingly low rate of alopecia. In the Genevieve study it will be compared against~     weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A~     head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison~     of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further~     development of this taxoid in breast cancer is reasonable.~   "
97605|NCT01779466|"~     This trial will investigate the relationship of sleep, daytime performance and nocturia in~     patients treated with Desmopressin or placebo. Male and Female patients will be administered~     Desmopressin or Placebo every day for 3 months.~   "
97606|NCT01779453|"~     This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering~     efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy~     of atorvastatin 10 mg.~   "
97607|NCT01779440|"~     Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five~     times higher than the rate of daily smoking in other young adults. Contrary to popular~     belief, smoking tobacco does not provide any benefit for mental illness symptom control.~     People with severe mental illnesses (SMI: schizophrenia and severe mood disorders) are~     dying, on average, 25 years earlier than those without SMI. Much of this early mortality is~     due to higher rates of heart and lung diseases, cancers, strokes, and diabetes.~      Cessation of smoking in these transition-age young adults can prevent cancer and increase~     life expectancy to that of non-smokers. Combination treatments are effective in this group~     and therefore key to improving outcomes, but few SMI smokers use them despite their interest~     in quitting. Motivational interventions for cessation increase interest in quitting, but~     public mental health clinicians do not deliver them, in part due to economic reasons. Thus~     cost effective methods to deliver motivational interventions to engage young smokers with~     SMI into treatment are needed.~      To address this gap, we have developed an electronic decision support system (EDSS) for~     smoking cessation that is specifically tailored for smokers with SMI, who tend to have~     cognitive deficits and limited computer experience. Similar to EDSSs developed for other~     health problems, this EDSS provides information and motivational exercises within an~     easy-to-use, web-based computer program that can be used with minimal or no staff~     assistance. Initial piloting of the EDSS in middle-aged SMI smokers showed excellent~     usability and promising efficacy. Pilot-testing among young patients suggested that the EDSS~     increased motivation to quit smoking and provided direction to adapt the format and content~     of the EDSS for young SMI smokers.~      The purpose of this proposal is to further develop the motivational decision support system~     and to test its ability to motivate young smokers with SMI to quit smoking with cessation~     treatment.~   "
97608|NCT01779427|"~     This is a research study to learn if a computer-based intervention that provides direct~     attention and metacognitive strategy development can improve attention, memory, and~     executive control in adolescents with moderate-to-severe TBI who are experiencing attention~     difficulties post injury.~   "
97619|NCT01779284|"~     The primary objective of this crossover trial is to compare the 3-month, mean 24-hour~     intraocular pressure (IOP) control and safety obtained with two popular fixed combinations~     in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will~     compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium~     chloride given once in the evening, versus the latanoprost/timolol fixed combination given~     in the evening. It is assumed that travoprost/timolol fixed combination will provide better~     quality of 24-hour pressure control.~   "
97620|NCT01779271|"~     Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3~     Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in~     patients with Acute upper respiratory infection.~   "
97609|NCT01779414|"~     This study looks to implement a novel intervention (STAT-ED) for children who screen~     positive to suicide ideation. The intervention looks to collect data from several different~     measures and then randomize participants into one of two groups: a control group where the~     participant will be set up with a mental health referral from a psychiatric social worker;~     or if randomized into the STAT-ED intervention, the adolescent and parent will receive a~     brief motivational interview, barrier reduction discussion, referral and limited case~     management by the study social worker to enhance outpatient mental health follow up after~     discharge from the ED.~      The hypothesis of the study is patients who are randomized into the STAT-ED intervention~     group will have a significantly higher rate of initiating mental health treatment and will~     attend more mental health treatment sessions in the two months after the ED visit compared~     with adolescents in the control group. Secondary aims of this study look to determine~     whether the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity;~     and evaluate predictors and mediators of mental health treatment engagement.~   "
97610|NCT01779401|"~     To identify the high-risk patients who might have in-stent thrombosis after PCI with~     thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic~     strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with~     the standard antiplatelet therapy.~   "
97611|NCT01779388|"~     Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy~     will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique~     needing validation. the primary aim of the study is to compare ENB to radiologically guided~     bronchoscopy, considered the standard comparator.~   "
97612|NCT01779375|"~     The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with~     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose~     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal~     of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following~     treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin~     glargine followed by metformin.~      The primary clinical question RISE will address is: Are improvements in ß-cell function~     following 12 months of active treatment maintained for 3 months following the withdrawal of~     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal~     of therapy, and whether biomarkers obtained in the fasting state predict parameters of~     ß-cell function, insulin sensitivity and glucose tolerance and the response to an~     intervention.~   "
97613|NCT01779362|"~     The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with~     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose~     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal~     of treatment. Adult participants (ages 20-65) will be randomized to one of the following~     treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive~     insulin treatment with basal insulin glargine followed by open-label metformin, (4) the~     glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.~      The primary clinical question RISE will address is: Are improvements in ß-cell function~     following 12 months of active treatment maintained for 3 months following the withdrawal of~     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal~     of therapy, and whether biomarkers obtained in the fasting state predict parameters of~     ß-cell function, insulin sensitivity and glucose tolerance and the response to an~     intervention.~   "
97614|NCT01779349|"~     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is~     invasive time consuming and requires expensive and complex set-up. In this study the~     investigators plan to evaluate an alternative technology that presumably is able to diagnose~     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow~     Vibration Analysis technology. The acoustic vibration sensor is a small device that records~     the vibration due to urine flow. The patient attaches the sensor to the penis using a~     disposable sensor patch for the duration of approximately one minute during one urination.~     The analysis is performed off-line and the results are compared to the results of a standard~     pressure flow study and to the standard free flowmetry test. The innovative technology for~     the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve~     complex setup.~   "
97615|NCT01779336|"~     Clinical study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid~     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting~     toxicity (ies) of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid~     tumors.~   "
97616|NCT01779323|"~     The hypothesis is men with stress urinary incontinence, including those following radical~     retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as~     measured by magnetic resonance imaging (MRI) that improves significantly following sling~     placement. The investigators theorize that the sling helps with primary hypermobility of~     this pathophysiologic cause of stress urinary incontinence.~   "
97617|NCT01779310|"~     There are guidelines on the management of AD in China, the evidence adopted in the~     guidelines are mostly from the trials conducted in other countries due to very limited~     Chinese data available for local systematic review. Therefore, more local evidence on~     dementia care is needed for the development of an evidence-based guideline appropriate for~     people living in China. Meanwhile, the inadequate implementation of the current AD~     guideline, which results in the low diagnostic rate and high diagnostic leakage, may bring~     about extra barriers for AD patients to access dementia care service in different areas~     nationwide. However, there is no data on the clinical pathway about how physicians follow~     the dementia guideline in the routine practice.~      Therefore, research is needed to learn clinical diagnostic process and treatment patterns of~     physicians to people with AD in routine practice and help address the low accurate rate of~     AD clinical diagnosis and low anti-dementia drug prescription in the real world and support~     guideline development.~   "
97618|NCT01779297|"~     The purpose of this study is to determine whether introducing the new weaning indexes can~     predict better than traditional ones?~   "
97621|NCT01779258|"~     The purpose of this study is to confirm that emollients play a major role in the maintenance~     therapy after clearing of inflammatory lesions and can reduce occurrence of flares in~     children with atopic dermatitis.~   "
97624|NCT01779219|"~     Background: The aim of the study was to assess the safety and effectiveness of stereotactic~     brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison~     with its frameless classic analogue based on a prospective randomized trial.~      Patients are prospectively randomized into a low-field iMRI group and a control group that~     undergo a frameless STx biopsy. The primary endpoints of the analysis are: postoperative~     complication rate and diagnostic yield, and the secondary endpoints: length of hospital stay~     and duration of operation.~   "
97625|NCT01779206|"~     Trial for the optimization of risk assessment and therapy success prediction in patients~     with early breast cancer by the use of biomarkers in advance to therapy decision-making to~     personalize therapies.~   "
97626|NCT01779193|"~     B streptococcal infection and the major cause of death before and after the baby is born. B~     streptococcus infection the way of the newborn, usually infection from the mother in~     childbirth, if the pregnant women during pregnancy early diagnosis B streptococcus~     infection, it can be effective in preventing the risk of neonatal infection. Department of~     Health in China has been since April 15, 2012, the Scholarship holder at all pregnant women~     in the 35-37 weeks of pregnancy comprehensive B streptococcus screening. Infection B~     Streptococcus pregnant women in the labor process, the use of prophylactic antibiotics can~     be effective in reducing neonatal B streptococcus infection, but the possibility of the~     fetus being infected for the condition of premature birth or early rupture of membranes are~     still unable to fully hedge. In this study, the 35 to 37 weeks gestation examination~     confirmed infected B Streptococcus pregnant women, oral lactobacillus capsules B~     streptococcus infection treatment efficacy and safety assessment of clinical research. To~     assess whether oral administration of lactic acid bacteria will affect vaginitis incidence.~   "
97627|NCT01779180|"~     INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A~     supplementation (NVAS) have been reported, and another four are underway to test whether~     NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim~     Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among~     low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU~     vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is~     local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong~     harmful effect of NVAS on atopy and wheezing was found (manuscript under review).~      Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS~     is associated with a higher risk of atopy and wheezing. The investigators therefore aim to~     conduct a similar follow-up study of participants in the first NVAS trial conducted in~     Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is~     associated with an increased risk of atopy and wheezing and other allergic symptoms as well~     as growth.~      METHODS~      Study population:~      From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited~     newborns when they came for BCG vaccination. Provided parental consent, they received an~     oral supplement of 50,000 IU vitamin A or placebo.~      Study design:~      This study will be a follow-up study of the cohort of children randomised to NVAS~     (intervention) or placebo (current policy) together with BCG vaccine at birth.~      Other exposures:~      The investigators will also investigate the effect of receiving an additional dose of~     measles vaccine and the timing of DTP vaccine on the development of atopy.~      Assessment of outcomes:~      The investigators will visit all children at the last known address. Height, weight and mid~     upper arm circumference will be measured. BCG scar will be examined and vaccination card~     details recorded by the field assistant. Children will be excluded from skin prick testing~     (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine~     medication. SPT will be performed using aero-allergens, food allergens and positive~     histamine and negative saline control. The mother or guardian will be interviewed by a local~     assistant. Symptoms of eczema and asthma as well as food allergy will be assessed.~      Statistical analysis:~      Effect of randomisation group and other factors on outcomes will be analysed in~     multivariable regression models. All analyses will be adjusted for skin prick tester. All~     analyses will be conducted stratified by sex.~   "
97628|NCT01779167|"~     The purpose of this study is to evaluate the efficacy and safety of daily alternating~     thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated~     Waldenstrom macroglobulunemia (WM). Thalidomide and lenalidomide are drugs that modulate the~     immune system and have been shown to bring about responses in subjects with WM. However,~     their use has been limited due to side effects. The investigators hypothesize that~     alternating doses of thalidomide and lenalidomide may alleviate the side effects while~     preserving the effectiveness of the therapies.~   "
97629|NCT01779154|"~     The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that~     does not involve medical interventions, but serves as a record of demographics,~     characteristics of disease and treatment, utilization patterns, quality improvement measures~     and clinical outcomes. The database is proposed so that epidemiologic research can be~     performed and current and accurate data can be obtained regarding practice patterns, age and~     gender distributions, efficacy of treatment, clinical outcomes and changes in quality of~     life.~   "
97630|NCT01779141|"~     Purpose:~      The aim of this observational study (registry) is to document the use of insulin pump~     therapy (CSII) and sensor augmented pump therapy (SAP) before, during and after pregnancy in~     women with Type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm~     REAL-Time and Paradigm Veo pumps in Poland.~      Objectives:~      To assess the benefits of CSII and SAP on the maternal glycemic control; To assess the~     prevalence of pregnancy complications (rates of preterm delivery, infant birth weight,~     neonatal care admissions) from preconception phase, throughout pregnancy, during delivery~     and after delivery during lactation phase (up to 6 weeks); To report and assess the~     potential benefits of SAP or CSII on neonatal outcomes~   "
97631|NCT01779128|"~     This research study is an imaging pilot study. Imaging pilot studies explore the potential~     benefit of one imaging approach compared to another clinically accepted approach. Such~     studies serve to understand how feasible an approach may be and whether it is worth pursuing~     in formal and larger clinical trials. Researchers of this study believe that simultaneous~     Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer~     additional imaging information to improve cancer detection.~      MRI and PET are two tests that allow us to take pictures of the body and look inside the~     body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body.~     The PET scanner makes pictures by using special dyes that light up inside the body. PET~     scans use radiation, similar to the radiation in a standard x-ray. We routinely use both~     tests to diagnose various types of cancer. As of now, the combination of PET and computed~     tomography (CT) has been considered a standard of care imaging approach for various cancers.~      Until recently, MRI and PET tests were done separately. Now there is a new type of test~     called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and~     PET tests at the same time. We would like to find out if the MR-PET scanner can produce~     better and clearer images (pictures) of tumors and information about them inside of the~     body.~      This new MR-PET scanner is approved by the US FDA. However, some of the computer programs~     that tell the machine how to acquire and combine the test results are new and experimental.~     Experimental means that some of the computer programs are not approved by the FDA. This~     means that they can only be used in research studies. The MR-PET scanner has been previously~     used in a few human participants.~   "
97632|NCT01779115|"~     A computerized registry of diabetes patients in a large health maintenance organization in~     Israel. The registry is aimed to be used by health professionals to identify diabetes~     patients and to follow the courses of their illnesses and risk factors.~   "
97633|NCT01779102|"~     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum~     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a~     positive test result will show as redness and/or induration at the injection site, while a~     negative test will leave no reactions.~      The aim of this study is to address if the size of induration and the sensitivity of C-Tb is~     influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is~     to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.~   "
97634|NCT01779089|"~     Diabetic kidney disease increases the risk of illness and death from heart disease in~     patients with Type 2 diabetes. Some blood pressure medications called ACE inhibitors and~     ARBs slow progression of kidney disease, but the dose that can be used is often limited by~     side effects that are experienced by patients. The most limiting side effects of the current~     treatments are lowering of the kidney function or blood pressure, and a rise in blood~     potassium levels. A safe and inexpensive medication that doesn't lower kidney function or~     blood pressure or raise serum potassium would be useful.~      Minocycline is a tetracycline antibiotic with recently appreciated protective properties. In~     a published journal article by Dr. Isermann, minocycline prevented the death of specialized~     kidney cells in mice. The kidneys of these mice did not develop diabetic kidney disease when~     seen under the microscope and the mice experienced only a little bit of protein loss in the~     urine. In a different published paper, the authors showed that minocycline also decreased~     kidney injury in a model of non-diabetic kidney disease. A related tetracycline antibiotic~     was shown to lower urine protein in diabetic patients. These data support a rationale for~     testing to see if minocycline is safe and helpful in patients with diabetic kidney disease.~     In this study, all patients will stay on their usual medications for the treatment of~     diabetic kidney disease. Patients will be given either minocycline (100 mg by mouth twice a~     day for 24 weeks) or placebo (an inactive capsule taken twice a day for 24 weeks).~     Minocycline or placebo will be assigned by a process called randomization, which is like a~     coin toss. Neither the patient nor the study team will know if the patient is taking placebo~     or minocycline until the end of the study. The study will assess minocycline safety and test~     to see if minocycline is helpful or not helpful for the treatment of diabetic kidney~     disease.~      This study was funded by the American Diabetes Association and is not supported by any~     pharmaceutical company.~   "
97635|NCT01779076|"~     Using a protective ventilation strategy during general anesthesia from pre-oxygenation to~     emergence and selecting patients without risk of a difficult airway or intubation, a lower~     fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the~     postoperative area of atelectasis without desaturations becoming more common.~   "
97636|NCT01779063|"~     Lymphedema is a chronic condition that causes physical and emotional challenges to breast~     cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis~     that can impair function, promote infection, and cause discomfort and emotional distress.~     Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and~     lifelong. Previous studies found that about half of breast cancer survivors with lymphedema~     do not complete self-care as directed. Feelings of being helpless to manage the condition, a~     desire to be normal, lack of noticeable results from self-care, and poor social/healthcare~     professional support are barriers to performing self-care on a regular basis. There is a~     need to develop and test interventions to promote effective self-care. Experts suggest the~     best self-care interventions should include patient perspectives and be available a readily~     accessible format. Technological advancements support use of innovative, creative~     approaches, such as Web-based multimedia interventions. Web-based interventions can be used~     in rural and urban settings. The investigators are proposing to develop a Web-based,~     multimedia intervention and a take home manual to support self-care in breast cancer~     survivors with lymphedema. The investigators plan to conduct focus groups with these~     survivors to determine the content and delivery format(s) and to help us identify breast~     cancer survivors with lymphedema for the video component. The investigators will then~     develop an intervention that will include self-care demonstrations and other supportive~     information to help patients to cope with the challenges of self-care. The focus groups will~     reconvene, review the intervention, and give us feedback on modifying and refining the~     intervention. After finalizing the intervention, The investigators will recruit more breast~     cancer survivors with lymphedema and provide one half of them an education booklet and the~     other half the Web-based intervention (or an alternative format such as DVD). Then, over 12~     months, the investigators will periodically assess and compare both groups on self-care~     behaviors, physical and emotional concerns, and other issues such as money spent on~     lymphedema treatment. The group that receives the education booklet will be given access to~     the Web-based intervention after the 12 month follow-up is done, but the investigators will~     not ask them to complete any more forms.~      This project builds upon the investigators prior work that has provided information about~     lymphedema self-care problems and the investigators previous experience in developing~     patient education videos and manuals. By providing accessible, detailed self-care~     instructions and a psychosocial component, this intervention has the potential to improve~     lymphedema self-care. If successful, this intervention can be offered to the larger national~     and international community of breast cancer survivors with lymphedema.~   "
97637|NCT01779050|"~     This phase II trial studies the efficacy of trastuzumab treatment in breast cancer patients~     with stage II-III human epidermal growth factor receptor 2 (HER2)-negative tumors and~     HER2-expressing bone marrow disseminated tumor cells. Administering targeted trastuzumab~     therapy to these patients may result in the elimination of HER2 expressing disseminated~     tumor cells and improved disease free survival.~   "
97638|NCT01779037|"~     IRF-PAI Functional Outcomes Data, including FIM instrument variables~   "
97738|NCT01777724|"~     The study will use a randomised controlled trial design to evaluate the effects of a~     combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress~     Control in comparison to a waitlist condition. The combined intervention will be evaluated~     with parents in Glasgow, United Kingdom, with a 3-8 year old child.~   "
97782|NCT01777139|"~     This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term~     safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy~     in adult Asian subjects with drug-resistant partial-onset seizures (POS).~   "
97639|NCT01779024|"~     Background:~      - Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes~     people feel hungry, and also is connected with the desire to drink alcohol. Researchers want~     to test ghrelin to see if it can be used to control alcohol cravings and use. They will~     compare doses of ghrelin with a placebo in people who drink heavily.~      Objectives:~      - To study the effects of ghrelin on alcohol craving and use.~      Eligibility:~        -  Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking~          treatment for alcohol use.~        -  Participants must on average have more than 20 drinks per week for men, and more than~          15 drinks per week for women.~      Design:~        -  Participants will have a screening visit, four 2-night study visits, and a follow-up~          visit.~        -  Participants will be screened with a physical exam and medical history. They will~          provide urine and breath samples for drug testing. They will also answer questions~          about mood and physical symptoms, and about alcohol and other cravings.~        -  At the study visits, participants will stay overnight at the National Institutes of~          Health clinical center. They will spend the night at the center, have tests on the next~          day, and go home on the following morning. At each visit, participants will receive a~          ghrelin or placebo infusion, and will complete a series of tasks.~        -  For the first and second study visits, participants will have tests of alcohol craving~          and use. They will be able to receive alcohol infusions through a computer program that~          tests response time and craving reactions. At the same time, they will have a ghrelin~          or a placebo infusion. Blood alcohol levels, reaction time, and craving will be~          studied.~        -  For the third and fourth study visits, participants will have a magnetic resonance~          imaging (MRI) study. They will have an initial MRI to provide a picture of the brain.~          They will then have a functional MRI during which they will respond to a computer test.~          The test will allow them to win points for snack food or alcohol. This test will look~          at the brain's response time and craving reactions.~        -  There will be a follow-up visit 1 week after the fourth study visit. Some of the tests~          from the screening visit will be repeated.~   "
97640|NCT01779011|"~     The prospective cohort study, SuTra2, assesses the functional and socio-economic status of~     patients who were operated on for a severe limb injury resulting in amputation or limb~     preservation 1 and 2 years after the 2010 Haiti earthquake.~   "
97641|NCT01778998|"~     One of the most recent advances in cataract surgery is microincisional phacoemulsification~     (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either~     bimanually or with a thin single coaxial hand-piece. The possible advantages are lower~     induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher~     resistance of the wound to deformation3 and a lower risk of complications such as iris~     prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome~     (IFIS). Additional factors that have to be taken into account are the construction and the~     position of the incision and the influence of the extraocular force on the wound~     morphology.4 Another effect that may influence the wound architecture is stromal hydration~     at the end of surgery.5 Wound architecture has recently been assessed6-9 using optical~     coherence tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing~     on corneal thickness and the incision angle. However, none of these studies observed the~     effect of the wound architecture on post-operative astigmatism. Furthermore, all~     observations in the past have been performed in the post-operative period only and~     information concerning the wound architecture intra-operatively is missing. A recently~     launched CE-marked intra-operative OCT allows observing the wound architecture~     intra-operatively.~      One aim of the study is to assess the influence of the intra-operative wound architecture~     using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to~     deformation of the wound and the surgically induced astigmatism in MICS and small incision~     cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged~     incision with a pre-cut should be assessed along the same line~   "
97642|NCT01778985|"~     This is a study to determine how vaginal estrogen cream given for several weeks before~     pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of~     the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will~     receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive~     surgery. At time of surgery, full thickness biopsies will be obtained from a standardized~     location at the top of vagina. The investigators will measure the thickness of the vaginal~     muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or~     degradation is affected by estrogen therapy. The results will provide important data to~     support a larger clinical trial to determine if preoperative and maintenance estrogen~     therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ~     prolapse.~   "
97643|NCT01778972|"~     Fall-related injuries are a major health problem in the growing older population. Most older~     people are not aware of that physical training can decrease the risk of falling. The aim of~     tha study is to investigate the effect of the Otago home exercise programme with and without~     motivational interviewing in community-dwelling people 75 years or older on frequence of~     falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of~     life, mortality and health-related costs.~   "
97644|NCT01778959|"~     Cataract surgery is one of the most frequently performed surgeries worldwide and~     complications are rare. However, there are factors that increase the risk of complications,~     such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a~     small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the~     use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers~     (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang~     and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for~     iris prolapse towards the phacoemulsification tip as well as towards the incisions and~     progressive intra-operative pupil constriction.~      Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it~     is of high importance to identify patients prior to surgery, who are treated with~     alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil~     dilation. Some methods, such as intracameral injection of phenylephrine is only sufficient~     in a few cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another~     pharmacological method is the use of atropine drops pre-operatively, but this method did not~     show to sufficiently reduce IFIS.4~      Different methods were shown to reduce intra-operative problems due to IFIS/small pupil~     size:~      The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called~     viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to~     viscodilate the pupil and by resting on the iris during the entire phacoemulsification~     procedure reduce the risk of iris prolapsing towards the incisions. This method is more~     dependent on a central phacoemulsification technique and low fluidic parameters to allow the~     OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil~     stretching with 2 instruments can be used additively.~      Another option to stabilize the pupil size is the use of mechanical pupil expansion devices,~     such as~        1. Iris retractors - these devices are routinely used to dilate the pupil~          intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are~          inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of~          overstretching is small.8~        2. Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil~          margin with an injector through the main incision. It eliminates the need of additional~          incisions and saves time.9~      Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract~     surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a~     viscoadaptive OVD.~   "
97739|NCT01777711|"~     This study explores among couples in which both members are obese how the use of mental~     contrasting along with implementation intentions influence intentions and behavior related~     to weight loss (eating healthy and exercise), actual weight loss, as well as potential~     reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in~     beliefs about weight loss, confidence in being able to eat healthy and diet).~   "
97792|NCT01777009|"~     Short and long term outcomes of total knee arthroplasty patients surgically exposed with~     patellar eversion are compared to those patients exposed by laterally retracting the~     patella. It was hypothesized that there would be no difference.~   "
97645|NCT01778946|"~     This study will ascertain whether nicotine is safe and tolerable in DS patients, help with~     dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning,~     and establish evidence for biological and behavioral correlates of nicotinic stimulation~     effects. The knowledge gained from the translational aspects of this project may also guide~     the application of new nicotinic drugs in DS and generate, for the first time, data on the~     importance of nicotinic receptor changes in the development of cognitive impairment in DS~     adults.~      Hypotheses:~        -  Transdermal nicotine treatment will be well tolerated out to one month by non-smoking~          DS patients without significant adverse effects.~        -  Nicotine will enhance cognitive performance by one month compared to baseline and~          post-treatment testing.~        -  Nicotine will enhance functioning detectable by clinician and/or informant ratings~          (pre-post).~   "
97646|NCT01778933|"~     According to the National Cancer Institute, an estimated 64,770 men and women will be~     diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this~     disease. Surgery remains one of the best options for patients presenting with operable Stage~     II or III cancers, however the five year survival rate for these candidates remains at a~     dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that~     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory~     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative~     margin through imaging during surgery it would be possible for the investigators to improve~     the rates of recurrence free patients and thus overall survival.~      Renal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of~     kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is~     expressed only in the proximal tubules of the kidneys, activated macrophages, and in the~     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A~     group well known to us in the Netherlands has completed a pilot study utilizing a~     folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in~     Mayo have subsequently performed this study on 20 more patients without any serious adverse~     events (personal communication). They report excellent sensitivity and specificity with this~     technique with only grade 1 side effects (allergic reaction). All side effects reversed when~     the injection was halted. Patients with a history of allergic reactions to insect bites~     should not participate (fluorescein is derived from the firefly insect, folate is an~     essential vitamin).~   "
97647|NCT01778920|"~     The goal of this study is to perform imaging of patient's tumors while the chest is open and~     the tumor is being removed.~      According to the World Health Organization, lung cancer is the most common cause of~     cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide~     annually as of 2004. Surgery remains the best option for patients presenting with operable~     Stage I or II cancers, however the five year survival rate for these candidates remains at a~     dismal 53% for Stage I and 32% for Stage II. The high rates of recurrence suggest that~     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory~     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative~     margin through imaging during surgery it would be possible for us to improve the rates of~     recurrence free patients and thus overall survival.~      Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85%~     of lung and pleural malignancies express folate receptor alpha (FRA). It is important to~     note that FRA is expressed only in the proximal tubules of the kidneys, activated~     macrophages, and in the choroidal plexus. Thus, the false positive detection rate is~     expected to be extremely low. A group well known to us in the Netherlands has completed a~     pilot study utilizing a folate-fluorescein isothiocyanate (folate-FITC) conjugate in 12~     patients with ovarian cancer. Another group of investigators in Mayo have subsequently~     performed this study on 20 more patients without any serious adverse events (personal~     communication). They report excellent sensitivity and specificity with this technique with~     only grade 1 side effects (allergic reaction). All side effects reversed when the injection~     was halted. Patients with a history of allergic reactions to insect bites should not~     participate (fluorescein is derived from the firefly insect, folate is an essential~     vitamin).~   "
97648|NCT01778907|"~     Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the~     national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are~     effective in reducing symptoms, especially in people with severe depression. To optimize~     treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal~     Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for~     antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype~     (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on~     pharmacogenetic information at the start of therapy can speed up the titration phase of~     antidepressants to establish an adequate maintenance dose. However, pharmacogenetic~     screening programs are expensive and evidence on effects and costs of such a program among~     elderly antidepressant starters from randomized controlled studies is lacking. The~     investigators will conduct a pragmatic randomized controlled trial to determine the effects~     and costs of pharmacogenetic screening information to optimize drug dosing in depressed~     elderly patients who start with nortriptyline or venlafaxine.~      Objective: The primary objective is to determine the effects of pharmacogenetic screening~     for CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate~     treatment. Secondary objectives include adverse drug reactions and cost-effectiveness~      Study design: pragmatic randomized controlled intervention study~   "
97649|NCT01778894|"~     According to the most recent information released by the American Heart Association, heart~     failure affects 5.8 million Americans and over 23 million people worldwide. In particular,~     diastolic heart failure (DHF) has emerged in approximately half of those suffering from~     heart disease and has become a major public health problem for many reasons, including the~     complexity of the disease, lack of effective drugs/therapies, requirement of invasive tests~     to diagnose and monitor DHF, and the absence of a suitable scientific model to study the~     disease. Scientists and physicians alike still do not fully understand what happens to the~     muscles in the heart (myocardium) patients who present with diastolic dysfunction or DHF.~     Therefore, the medical field is in need of an accurate model that can evaluate how diastolic~     dysfunction leads to heart failure and what happens at a cellular level as this disease~     emerges and progresses.~   "
97754|NCT01777516|"~     This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and~     its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic~     acid. The study consist of two parts of in-vitro study as follows;~        -  Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor~          and its active metabolite.~        -  Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor~          and its active metabolite and their effect on the pharmacodynamics of salicylic acid on~          platelet aggregation tests with the agonist of arachidonic acid.~   "
97650|NCT01778881|"~     Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth.~     It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the~     prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central,~     and psychosocial factors influence the disorder, which may predispose to pain in the~     masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and~     cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety,~     depression, and overall impairment of oral health. The aim of this study is to compare~     physical therapy interventions with dental treatment in pain, mandibular opening, sleep~     quality, anxiety, stress, depression, and oral health in individuals with bruxism.~   "
97651|NCT01778868|"~     Hormonal disruption is the inappropriate alteration of the hormonal system by chemical~     substances that are present in our environment. Some chemical substances are capable of~     replicating, enhancing or reducing the production, release, transport or action of natural~     hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic'~     endocrine disrupters such as pesticides and dioxins are considered responsible for~     infertility, cancer and thyroid problems. Recently, a number of additional chemical~     substances were stipulated to have endocrine disrupting capabilities. The industrial~     production of these substances in large quantities has led to an accumulation in our~     environment and thus possible negative consequences on human health.~      The aim of this study is to investigate the rol of these chemical substances in the~     occurence of overweight and obesity.~   "
97652|NCT01778855|"~     The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to~     compare key imaging measurements for serial changes in recanalization and reperfusion~     between hypothermia and normothermia treatment arms as intermediate outcomes of treatment~     effect. Secondary exploratory analyses include imaging of the neurovascular impact of~     reperfusion with hypothermia and tPA, including blood-brain barrier changes or permeability,~     hemorrhagic transformation, and infarct growth.~   "
97653|NCT01778842|"~     The elderly represent a growing segment of the coronary population treated by dual~     antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a~     higher risk of both ischemic events and bleeding complications than younger patients, with a~     subsequently higher rate of mortality.Recentprogress in antithrombotic treatment~     demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether~     this benefit is also present in the elderly remains a debated issue due to the lack of~     specific data in this sub-population. The present study was realized to provide specific~     data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly~     patients (≥75 years old) whereas the superiority in PR response of the latter should allows~     the Prasugrel therapy in elderly patients with the better clinical efficacy and~     therapeutical safety already showed compared with Clopidogrel.~   "
97654|NCT01778829|"~     The purpose of this study is to determine whether Nasal intermittent positive pressure~     ventilation (NIPPV) non synchronized is better than continuous positive airway pressure~     (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth~     weight infants at the NEOCOSUR Network.~   "
97655|NCT01778816|"~     Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types:~     open, percutaneous and conservative (non-operative) treatments.~      Comparing force torque measurements, muscle volume and clinical scores.~   "
97656|NCT01778803|"~     This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in~     combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with~     advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose~     Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the~     safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer~     activity of defactinib (VS-6063) when administered in combination with paclitaxel.~     Pharmacodynamic effects will also be examined in tumor biopsies.~   "
97657|NCT01778790|"~     The investigators will investigate in a sham controlled staggered onset design~     antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral~     branch of the main medial forebrain bundle (slMFB).~   "
97658|NCT01778777|"~     The primary safety objective is to demonstrate that severe device-related complication~     (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at~     a rate of less than 2%. Such adverse events include (but are not limited to) revisions due~     to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring~     surgical repair.~   "
97659|NCT01778764|"~     The investigators will learn from this study if the CyberKnife radiosurgery (CK RS)~     treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall~     survivals. The importance of this new knowledge will be to determine the treatment efficacy~     of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give~     data to support either the continuation or modification of the CK RS treatment of patients~     with brain metastases.~   "
97660|NCT01778751|"~     This study will determine whether Home Telehealth-based implementation of an evidence-based~     intervention targeting Veterans with persistent poorly-controlled diabetes can improve~     hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk,~     high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care)~     offers a feasible, sustainable, and generalizable approach to managing Veterans with~     persistent poorly-controlled diabetes, which can be implemented using only existing Home~     Telehealth services.~   "
97676|NCT01778543|"~     Background:~      - Uveal coloboma is a condition where the eye does not form normally. It occurs early in the~     fetus s development during pregnancy. It can lead to different kinds of eye problems,~     including blindness. Several genes have been linked to coloboma, but the cause of most cases~     is hard to find. Researchers want to study the genes of people who have coloboma and genes~     from their close, unaffected relatives (such as parents and siblings).~      Objectives:~      - To study the genes associated with uveal coloboma.~      Eligibility:~      - Individuals at least 1 years of age who either have uveal coloboma or are an unaffected~     relative (such as a parent or sibling).~      Design:~        -  Participants will have a physical exam and medical history. They will also have a full~          eye exam.~        -  Participants with uveal coloboma may have other exams, such as imaging studies and~          hearing assessments.~        -  All participants will also provide blood and cheek swab or saliva samples for genetic~          testing.~   "
97661|NCT01778738|"~     The Roux-en-Y gastric bypass operation combines restrictive and malabsorptive principles. It~     is the most commonly performed bariatric procedure worldwide (~ 50 %). Vertical (sleeve)~     gastrectomy on the other hand, is a purely restrictive procedure and has gained popularity~     and is now accepted as a valid procedure accounting for approximately five percent of the~     bariatric procedures performed worldwide.~      The remission rate of type 2 diabetes one to two years after bariatric surgery is~     approximately 70%. Some studies have indicate that the remission rate of type 2 diabetes is~     higher after gastric bypass than after sleeve gastrectomy. Other studies indicate a similar~     effect on the reduction in HbA1c.~      Weight reduction is comparable between gastric bypass and sleeve gastrectomy although some~     evidence suggets a larger weight loss following gastric bypass surgery. Larger weight loss~     can clearly contribute to somewhat greater improvement in glucose homeostasis after gastric~     bypass than after sleeve gastrectomy. Still, one might speculate that changes in gut~     hormones may contribute to higher remission rates of type 2 diabetes after gastric bypass~     than after sleeve gastrectomy.~      Improved β-cell function observed after gastric bypass surgery may be linked to higher~     postprandial levels of Glucagonlike peptide 1 as seen after gastric bypass surgery. Beta~     cell function has, to our knowledge, only been addressed in one previous study after sleeve~     gastrectomy, with the authors reporting an increased first-phase insulin secretion three~     days after the procedure. Although several studies have addressed changes in~     gastrointestinal hormones the incretin effect on insulin secretion after gastric bypass has~     been estimated in only a few studies. To the best of our knowledge the incretin effect on~     insulin secretion after sleeve gastrectomy remains unexplored.We are aware of four ongoing~     randomised controlled trials comparing the effect of gastric bypass and sleeve gastrectomy~     on several endpoints including weight and comorbidities (ClinicalTrial.gov identifiers:~     NCT00722995, NCT00356213, NCT00793143, and NCT00667706). However, these studies include both~     subjects with and with-out type 2 diabetes and are therefore not powered to detect~     between-group differences in HbA1c and beta-cell function in the diabetic patients.~      In conclusion, the effect of gastric bypass and sleeve gastrectomy on glycaemia is not fully~     elucidated. Moreover, the impact of altered beta-cell function post surgery needs to be~     explored. We hypothesise that greater improvement in beta-cell function after gastric bypass~     than after sleeve gastrectomy translates into better glycaemic control in subjects with type~     2 diabetes one year after surgery.~   "
97662|NCT01778725|"~     Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of~     the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus.~     Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before~     fulminant infection is developed. The aim of this study is to identify, as early as,~     possible signs of brain injury. S100B protein will be used as a marker for brain insult.~     S100b level were associated with the occurrence and size of stroke and brain trauma in~     adults and children. Moreover, S100B crosses the membrane and its level in women with~     preterm labor was associated with brain injury of preterm infant.~      The study question is whether the levels of S100B in women with early amniotic fluids~     breakdown are associated with future brain injury of the infant, as assessed by head~     ultrasound and neurological examination.~   "
97663|NCT01778712|"~     The aim of this study is to develop an intervention that will produce a sustained~     improvement in physical activity and chronic stress as a means to slow the menopause-related~     accumulation of visceral adipose tissue in mid-life women.~   "
97664|NCT01778699|"~     In a previous study the efficacy of Lb CD2 on interim covariates related to caries~     development was tested. So, it was decided to plan a new study on schoolchildren from the~     same area. The aim of the present research protocol was to evaluate the anticariogenic~     effect of probiotics daily used, on the caries development in children. The null hypothesis~     was that the probiotic Lb CD2 would not modify the caries risk of the children. Moreover,~     the study will be carried out to investigate the plaque acidogenicity in situ following the~     regular consumption of a probiotic product compared to a control group.~      Objective: To determine the effect of a regularly consumed probiotic on the development of~     new caries lesions.~      Study design: Double blind, placebo-controlled, longitudinal study, monocentric, national,~     in situ~   "
97665|NCT01778686|"~     The serotonin 2A (5-HT2A) receptor is the most abundant excitatory serotonin (5-HT,~     5-hydroxytryptamine) receptor in the human brain, and multiple positron emission tomography~     (PET) studies have investigated the 5-HT2A receptors in the human brain using antagonist~     radioligands. However, the currently available antagonist PET radioligands bind the total~     pool of 5-HT2A receptor receptors whereas a 5-HT2A receptor agonist binds the high-affinity~     subgroup of the receptors which are also G-protein coupled, and thus hypothesized to be the~     functional relevant population of receptors. At the Center for Integrated Molecular Brain~     Imaging (CIMBI), a novel agonist PET radioligands for brain imaging of 5-HT2A receptors was~     recently validated in animals (Ettrup et al. 2011, EJNMMI). In the human brain,~     [11C]Cimbi-36 was validated as a selective 5-HT2A receptor agonist PET radioligand through a~     blocking study with the 5-HT2A receptor antagonist pharmaceutical ketanserin. In this~     validation study, the biodistribution and kinetic modelling of [11C]Cimbi-36 binding in the~     human brain was also validated. With these studies, investigators will test the most~     promising of these, [11C]Cimbi-36, in clinical trials, where it will provide a novel method~     for detecting dysfunction in the 5-HT system. The specific aim of this clinical trial is:~      - To examine the effect of acute alterations in 5-HT levels on cerebral [11C]Cimbi-36~     binding in healthy volunteers who will be PET-scanned at baseline and after pharmacological~     or dietary interventions that either increase or decrease cerebral 5-HT levels.~      It is hypothesized that this novel agonist radioligand will provide both a more~     physiological relevant measure of the 5-HT2A receptors and also reflect levels of cerebral~     5-HT in humans, more specifically:~      BP will decrease after pindolol and selective serotonin reuptake inhibitor (SSRI) treatment~     and increase after acute tryptophan depletion (ATD). Placebo will leave binding potential~     (BP) unchanged.~   "
97666|NCT01778673|"~     Background: Although fractures of the distal radius are the most common skeletal injury, the~     utility of the available classification systems to predict fracture stability is limited. We~     studied if cortical comminution and intra-articular involvement can assess instability in~     fractures of the distal radius.~      Methods: A prospective multicenter study was conducted. Distal radius fractures in 417~     skeletally mature patients (428 fractures) were studied. Fractures were divided into~     osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and~     lateral plain radiographs determined if the fractures were minimally displaced or displaced.~     The fracture patterns were evaluated depending on the presence and the site of cortical~     comminution and intra-articular involvement according to a new classification system~     (Buttazzoni classification). Minimally displaced fractures were treated with cast~     immobilization. Displaced fractures underwent closed reduction with subsequent cast~     immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months.~     Displacement was classified as primary instability, secondary instability or late~     instability. Endpoints were union of the fracture or re-displacement. Results: Volarly~     comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni~     3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted~     (Buttazzoni 1) in 16 % of the cases. One third of the initially minimally displaced~     fractures did not maintain acceptable alignment. All initially displaced volarly comminuted~     fractures were unstable. In both initially displaced and minimally displaced fractures,~     cortical comminution and intra-articular involvement were predictive for primary, secondary~     and late instability.~      Conclusions: Cortical comminution and intra-articular involvement seem to be valuable~     instruments for assessing stability at initial presentation of distal radius fractures.~     Level of Evidence: Level I, prospective multicenter study. Prognostic study.~   "
97667|NCT01778660|"~     This study compares standard versus mnemonic counseling for the treatment of fecal~     incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women~     randomised to mnemonic counseling will higher recall of treatments, satisfaction with the~     physician visit and greater improvement in their quality of life when compared to women who~     received standard counseling.~   "
97668|NCT01778647|"~     Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food~     supplement in children with ADHD. No clear evidence for their role in this disorder is yet~     available.~      We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain~     significant results regarding this question.~   "
97669|NCT01778634|"~     The purpose of this study is to determine whether intravenous azithromycin is effective in~     eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks~     gestation.~   "
97670|NCT01778621|"~     Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims~     to compare assisted reproduction outcome between two groups of infertile PCOS patients~     underwent IVF, one group received acupuncture and other group without acupuncture.~   "
97671|NCT01778608|"~     Sedation is often administered to relieve anxiety and discomfort during uncomfortable~     procedures in elderly patients. Patient control of sedation offers many potential benefits~     for patients and healthcare professionals, including improved safety and patient~     satisfaction. The investigators overall goal is to develop a patient controlled intravenous~     sedation system that is effective but very safe for the patient, and requires minimal~     supervision by a doctor or nurse. To fulfill these criteria, a sedation system should~     incorporate fail-safe safety mechanisms. A key safety-critical component is a method of~     objectively assessing the degree of sedation of the patient, and of preventing him from~     self-administering unsafe doses of the sedative drug. The investigators have designed a new~     sedation system that uses a measure of the speed of response of the patient to a defined~     non-noxious stimulus to determine whether or not it is safe to allow him to self-administer~     further levels of sedation. Before being able to execute a volunteer study in order to~     determine a rational selection of optimal threshold response time, a feasibility test on the~     handset device is required.~   "
97672|NCT01778595|"~     Background:~      - Early detection of colon cancer can improve the chances of successful treatment for most~     people. This approach is especially important if blood is detected in the stool. However,~     much better stool sample tests are needed to find this cancer early. To improve the tests,~     researchers want to collect samples from people who are already being screened for colon~     cancer. This study will collect information and samples from older adults in Shanghai,~     China. These adults will be participating in screening tests for colon cancer.~      Objectives:~      - To collect samples and medical information for colon cancer screening from older adults in~     Shanghai, China.~      Eligibility:~        -  Adults between 50 and 74 years of age who are being screened for colon cancer.~        -  Participants will be recruited from two community health centers in Shanghai, China.~      Design:~        -  Participants will provide information on their medical history and factors related to~          colon cancer. They will respond to questions on use of medications, diet choices (such~          as eating red meat), bowel habits, and other factors.~        -  Participants will collect samples for study. These samples will be collected within 3~          days of the screening visit. Particpants will provide a urine sample and four stool~          samples. They will also use cotton swabs to collect samples from just inside the anus.~          The samples will be returned to the study doctors for research tests that may indicate~          who has colon cancer.~        -  Treatment will not be provided as part of this study.~   "
97673|NCT01778582|"~     Background:~      - Very few people with cancer participate in clinical trials. Some are uncertain about the~     treatment, or are afraid of being treated like a guinea pig. They may also feel that they~     have inadequate information about the trial. One possible way of encouraging people to sign~     up for clinical trials is to improve the informed consent process. Researchers want to~     understand how people read and understand informed consent documents.~      Objectives:~      - To study perspective taking, and to study how people understand the information and~     enrollment process for a clinical trial.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  This study will require one study visit.~        -  Participants will watch one of four movie clips. They will be asked to respond to the~          film by looking at it from the main character s perspective. They will then answer~          questions about how the clips made them feel.~        -  Participants will read a sample cancer clinical trial consent form on a computer. The~          computer will record their eye movements while they read the text. They will then be~          asked whether they remember the information in the consent form, and whether they would~          participate in the trial.~        -  No treatment will be provided as part of this study.~   "
97674|NCT01778569|"~     Background:~      - Cardiometabolic diseases are medical disorders that can occur together and affect the~     heart. They increase the risk of developing heart disease and diabetes. One disorder,~     psoriasis, is an inflammation that mostly affects the skin but can affect the entire body.~     Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited~     on the wall of arteries. This causes arteries to harden and become less flexible. Many cells~     that cause psoriasis also cause atherosclerosis. Researchers want to look at the~     relationship between cardiometabolic diseases and psoriasis.~      Objectives:~      - To study the relationship between psoriasis and cardiometabolic diseases.~      Eligibility:~      - Individuals at least 18 years of age who have psoriasis.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have up to seven outpatient visits over the 4 years. The first visit~          will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5,~          will be scheduled yearly for the next 3 years. If participants have a psoriasis flare~          with more severe symptoms, they may have an extra visit. Those who leave the study~          early will have a final visit with the full series of tests.~        -  At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and~          medical history. They will provide blood and urine samples, as well as optional tissue~          biopsies. They will also have heart function tests. Imaging studies, as well as~          optional photographs of affected areas, will be performed. These tests will also be~          performed at the final visit.~        -  At visits 3 and 4, participants will have a physical exam and medical history. They~          will also provide blood and urine samples, and have heart function tests.~   "
97675|NCT01778556|"~     Background:~      - Lipodystrophy is a condition where people do not have enough fat in the body. People with~     lipodystrophy can have problems such as diabetes or an enlarged liver. Researchers are~     looking at how leptin, a hormone produced by fat cells, can help people with these problems.~     Leptin helps control appetite and how the body stores food. Taking leptin can help people~     with lipodystrophy eat less food, which may help treat diabetes and other problems. To~     better understand how leptin works, researchers want to do an inpatient study on leptin~     treatment in people with lipodystrophy.~      Objectives:~      - To study how leptin treatment affects lipodystrophy.~      Eligibility:~      - Individuals between 14 and 70 years of age who have lipodystrophy.~      Design:~        -  All participants will have a 19-day stay at the National Institutes of Health Clinical~          Center. One group of participants will have tests for 5 days before starting to take~          leptin. They will then take leptin for 2 weeks, and have more tests. The other group of~          participants will have tests for 5 days while taking leptin. They will then take stop~          taking leptin for 2 weeks, and have more tests, and then they will start taking leptin~          again.~        -  Participants will have regular blood and urine tests during the visit. Some of the~          blood tests will look at insulin levels. Some will look at how the body metabolizes~          sugar and fat. Other tests will check hormone levels, especially of reproductive~          hormones.~        -  During the visit, participants will spend 3 separate days in a metabolic chamber, a~          special room that measures how many calories the body uses. Urine samples will be~          collected during these stays.~        -  Participants will also have several body imaging studies, including magnetic resonance~          imaging and a body composition scan.~        -  Physical activity will be tested with an exercise bicycle and an electronic activity~          monitor.~        -  Participants will be asked questions about hunger and comfort levels throughout the~          stay.~   "
97740|NCT01777698|"~     Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of~     patients with hepatocellular carcinoma are associated with cirrhosis.~      Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into~     the hepatic tumor where the principal artery is embolized.~      Bioelectrical impedance bases its evaluation in a model where the body is conformed by two~     different compartments: fat mass and fat free mass.~      Bioelectrical impedance is complemented by vectorial analysis, which is independent to the~     state of hydration and is helpful to monitor any changes in corporal composition. It can be~     used as a control for the interpretation of the bioelectrical impedance.~   "
97741|NCT01777685|"~     The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral~     administration.~   "
97677|NCT01778530|"~     Background:~      - Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is~     an experimental drug that blocks the growth of new blood vessels. It is being studied for~     possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be~     used to treat glioblastoma that has not responded to standard treatments.~      Objectives:~      - To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have glioblastoma that has not responded to~     standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and other tests will be used to study the~          tumor before the start of treatment.~        -  Participants will have 28-day (4-week) cycles of treatment.~        -  Participants will have TRC105 intravenously once a week. The first infusion will take~          about 4 hours. The length of time needed for the infusion may be slowly reduced if it~          is well tolerated.~        -  At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated~          before continuing TRC105.~        -  Participants will take TRC105 for as long as the tumor does not grow and the side~          effects are not too severe. They will have imaging studies at the end of every cycle to~          evaluate the tumor.~   "
97678|NCT01778517|"~     Background:~      - Functional movement disorder (FMD) is a form of conversion disorder (CD). CD is a disorder~     in which a person has neurological symptoms that do not have a neurological cause. These~     symptoms can include pain, weakness, dizziness, and fatigue. Some thoughts on CD suggest~     that it may come from feelings of anxiety that are converted into physical symptoms.~     Treatment for FMD usually involves stress reduction, family help, and regular doctor s~     appointments. Therapy interventions, however, have not been well studied. Researchers want~     to see if people with FMD get better with psychotherapy. They will study two different types~     of psychotherapy: group therapy and a self-help manual.~      Objectives:~      - To test two different types of therapy treatments for FMD.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have a psychological exam, and answer questions about their mood and symptoms.~        -  Participants will be separated into three groups. One group will have group therapy.~          Another will use a self-help workbook designed for people with FMD, and have individual~          therapy sessions. A third group will just have standard care. During the study,~          participants will continue to see their regular doctor.~        -  Group therapy participants will meet once a week for 6 months at the National~          Institutes of Health clinical center. There will be 8 to 10 people per group. Sessions~          will last 75 minutes. These sessions will work on methods for treating FMD.~        -  Self-help workbook participants will have six individual therapy sessions over 3 to 4~          months. They will use the workbooks to learn about and practice methods for treating~          FMD.~        -  All participants will be evaluated at 3, 6, and 12 months during the study.~        -  At the end of the study, participants will have a final follow-up session with exams~          and questions similar to the screening exam. They will return to the care of their~          regular doctor.~   "
97679|NCT01778504|"~     Background:~      - Many psychiatric, behavioral, and developmental disorders are genetic. This means that~     they tend to run in families. Some begin in childhood, while others do not appear until~     adulthood. Researchers want to look at people of all ages who have these disorders that~     started in childhood. They will also look at relatives of people with these disorders. This~     information will allow doctors to learn more about childhood behavioral problems and how~     they are inherited. It may also help doctors treat those disorders.~      Objectives:~      - To study the onset and treatment of childhood behavioral, psychiatric, and developmental~     disorders.~      Eligibility:~        -  Individuals of any age who have a psychiatric, autism spectrum, or developmental~          disorder, or other behavioral problems.~        -  Family members of individuals with the above disorders. This group may include parents,~          grandparents, siblings, aunts/uncles, cousins, and children.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine~          samples will be collected. Brain imaging scans will be performed to look at brain~          function. They may have a spinal tap to collect cerebrospinal fluid.~        -  Relatives will have a medical history and physical exam. They will also have a~          psychiatric history with tests of thinking, judgment, and behavior. Blood and urine~          samples will be collected. Brain imaging scans will be performed to look at brain~          function.~        -  A relative s exams may reveal a behavioral or other disorder. If so, he or she may~          re-enroll on the study as a person with the disorder.~   "
97680|NCT01778491|"~     Background:~      - Age-related macular degeneration (AMD) is a disease that blurs the sharp vision needed for~     activities such as reading, sewing, and driving. It affects the macula, the center of the~     retina at the back of the eye, which allows a person to see fine detail. Researchers want to~     collect medical histories, eye exam data, and genetic information that may be associated~     with AMD. They want to compare this information with information collected from people~     without AMD.~      Objectives:~      - To collect medical information and gene samples for researchers studying AMD.~      Eligibility:~        -  Individuals between and 60 and 90 years of age who have AMD in at least one eye.~        -  Individuals between and 60 and 90 years of age who have no AMD in either eye.~      Design:~        -  This study will involve one study visit. This study visit will last 6 to 8 hours.~        -  Participants will have the following tests and exams as part of their study visit:~        -  Full physical exam and medical history~        -  Full eye examination~        -  Laser scan of the eye~        -  Retina function test~        -  Vision sensitivity test~        -  Optional blood sample (for genetic study)~        -  No treatment will be provided as part of this study.~   "
97691|NCT01778348|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring~     lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections~     or the continuous insulin delivery using an insulin pump in order to keep blood glucose~     levels normal. We know that keeping blood sugars in the normal range will help prevent~     longterm diabetes-related complications involving the eyes, kidneys and heart. However,~     achieving treatment goals can be very difficult as the tighter we try to control blood~     glucose levels, the greater the risk to develop symptoms and signs of low glucose levels~     (hypoglycaemia). This is a particular problem at night and one solution is to develop a~     system whereby the amount of insulin injected is controlled by a computer and is very~     closely matched to the blood sugar levels on a continuous basis. This can be achieved by~     what is known as a closed-loop system where a small glucose sensor placed under the skin~     communicates with a computer containing an algorithm that drives an insulin pump. We have~     been testing such a system in Cambridge over the last five years in children and have found~     that this system is effective at maintaining tight glucose control and preventing nocturnal~     hypoglycaemia. More recently the system has been tested in real life conditions in the home~     setting for three weeks during a pilot single-centre study.~      The next step is to extend the evaluation of closed-loop over a prolonged period of three~     months. In the present study we are planning to study 24 young people aged 6-18 years on~     insulin pump therapy. During three months glucose will be controlled by the computer and~     during the other three months the subjects will make their own adjustments to the insulin~     therapy using real-time continuous glucose monitoring.~      We aim to determine the effect of the computer algorithm in keeping glucose levels between~     3.9 and 8 mmol/L (normal levels). Safety evaluation comprises assessment of the frequency of~     severe hypoglycaemic episodes. Participants' response to the use of the system in terms of~     lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We~     will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).~   "
97681|NCT01778478|"~     Background:~      - An interview called the Schedule for Affective Disorders and Schizophrenia for School Age~     Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems~     among children and younger teens. Both the child and a parent are asked questions about the~     child s behaviors and symptoms that might indicate such problems. Researchers want to see if~     the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two~     groups of young adults, including healthy volunteers and people with cancer, and their~     parents will participate in this study.~      Objectives:~        -  To see if the K-SADS-PL interview used for children and teens can also be used for~          young adults.~        -  To see whether information provided by parents will affect the rate of mental health~          problems found.~      Eligibility:~        -  Individuals aged 18-25 years who have cancer and are participating in research studies~          at the National Institutes of Health.~        -  Healthy volunteers aged 18-25 years.~        -  A parent of a young adult who is participating in this study.~      Design:~        -  This study requires one study visit that includes an interview and self-report~          questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will~          also be required.~        -  Young adult participants will be given the K-SADS-PL interview and four questionnaires~          that ask about mood, anxiety, distress, parental contact, and development during~          childhood. The K-SADS-PL interview will be video recorded or audio recorded.~        -  Parents will also be given the K-SADS-PL interview. This interview can be done in~          person or by phone, and will also be recorded.~        -  No treatment will be provided as part of this study.~   "
97682|NCT01778465|"~     Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma~     and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus~     surgeries and/or aspirin desensitization. However, these treatments have potential adverse~     effects.~      A theory has been postulated that decreasing the level of dietary salicylates may help in~     long-term control of disease. A current trial is in the works to evaluate the clinical~     outcomes of decreased salicylate, but measurements of biochemical markers of disease has not~     yet been done. The hypothesis is that decreased dietary salicylates will result in a~     decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which~     are typically elevated in this disease.~   "
97683|NCT01778452|"~     The aim of this study is to analyse genomics profile expression in endometrium under~     different endometrial priming for recipients.~   "
97684|NCT01778439|"~     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects~     with relapsed or refractory solid tumors. Study includes a dose escalation phase and~     expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,~     biomarkers, and efficacy.~   "
97685|NCT01778426|"~     Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over~     2 years following SCS implant.~      This study is requested by French Health Authorities for reimbursement renewal, to maintain~     reimbursement for SCS in approved indication in France.~   "
97686|NCT01778413|"~     The main objective is to determine the feasibility of maintaining virologic suppression on~     standard plasma viral load by dose reduction of ATRIPLA ®.~   "
97687|NCT01778400|"~     Ultrasound-guided ethanol ablation is an effective treatment modality for patients with~     cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly~     cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been~     reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26%~     (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to~     patients with incompletely resolved clinical problems after EA and the mean volume reduction~     ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both~     predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated~     the patients who were unsatisfactory after EA, to the best of our knowledge, no study to~     date has compared these two ablation techniques. Therefore investigators performed a~     prospective randomized study to compare single-session RF ablation and EA for treating~     predominantly cystic thyroid nodules.~   "
97688|NCT01778387|"~     The purpose of this prospective paper is to make a comparison between laparoscopic and~     opening approaches in ventral hernia repair, taking into account absence of recurrence in~     long - time (5 years), results centered at patient, especially satisfaction with~     expectations and improvement of normal physical activity, morbidity that particular form~     must include chronic pain, adjusted mortality through co-morbidities and, finally,~     prospective expenses, related to both effectiveness and utility~   "
97689|NCT01778374|"~     In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the~     Emergency Department, Mater Misericordiae University Hospital. We hypothesize that such a~     programme will be acceptable in an Irish setting. We also wish to study the factors that~     influence test completion or acceptance. We will utilise informative interactive video media~     via a touch-screen tablet device to provide pre-test counselling and then offer rapid~     minimally invasive testing with a cotton-bud type swab of the buccal mucosa. In doing so we~     will to determine absolute numbers of those attending the ED who consent to watching the~     interactive information video about rapid HIV test screening. We will describe the absolute~     number and proportion of those who watch the interactive video who subsequently proceed to~     have the rapid HIV test. The primary aim is to determine the cultural, gender and ethnic~     factors which influence the completion of such rapid HIV testing with the future objective~     of maximising test completion in this crucial public health area.~   "
97690|NCT01778361|"~     Despite the prevalence of osteopenia and osteoporosis in the HIV positive population,~     relatively little is known about the underlying pathology. This prospective cohort study~     aims to gain further understanding about a number of issues relating to low bone mineral~     density in HIV-infected subjects.~   "
97733|NCT01777789|"~     The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in~     middle-aged individuals with different levels of body fat. The ultimate goal of this~     research is to develop an early diagnostic tool for Alzheimer's disease.~   "
97734|NCT01777776|"~     To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered~     orally to patients with BRAF mutant melanoma.~   "
97793|NCT01776996|"~     This is an open-label protocol designed to provide continued access to maraviroc to only~     those subjects who have completed previous studies of maraviroc and continue to receive~     clinical benefit.~   "
97692|NCT01778335|"~     The purpose of the study is to understand whether a new treatment of stroke - endovascular~     clot removal - can be added to the current standard of care to improve patient outcomes.~      All patients will receive the best standard stroke treatment. This includes treating~     patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA~     does not work in some patients and others are not eligible to receive t-PA because they~     present too late for treatment (they woke up with their stroke symptoms or their stroke was~     not witnessed).~      During endovascular revascularization the blockage in the artery is removed with the use of~     devices called stentreivers and or by giving clot dissolving drug at the site of the~     blockage in the artery to restore blood flow. Stentrievers are devices that have been~     designed by different companies to remove blood clots from arteries.~      Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will~     participate in this study.~   "
97693|NCT01778322|"~     The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm~     Embolization System used to embolize intracranial aneurysms~   "
97694|NCT01778309|"~     In this investigation the investigators utilized NAC administration to foster GSH~     availability during an 8-day period following eccentric exercise-induced muscle damage in~     order to test our hypotheses: i) antioxidant supplementation does not disturb performance~     and adaptations induced by exercise-induced muscle injury and ii) redox status perturbations~     in skeletal muscle are pivotal for the regulation of muscle' inflammatory response and~     repair.~   "
97695|NCT01778296|"~     The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery~     because of its similar quality to the original. The dorsal digital island flap can be used~     for repairing the defect of adjacent finger, but the limited length of the pedicle precludes~     its use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal~     branch of the digital nerve can be used as an alternative to resolve this problem.~   "
97696|NCT01778283|"~     The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac~     index and cardiac output measured by saline dilution techniques compares with Acetate-based~     solution in online-hemodiafiltration~   "
97697|NCT01778270|"~     This study investigates if data about monitoring the drainage of pleural effusion can be~     collected by non invasive sensors (feasibility).~   "
97698|NCT01778257|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related~     death each year.~   "
97699|NCT01778244|"~     Almost all antipsychotics can induce dyslipidemia, but no treatment has been established.~     Metformin can improve lipid levels in obese patients. The investigators conducted a~     randomized, placebo-controlled study to test the efficacy of metformin for~     antipsychotic-induced dyslipidemia.~   "
97700|NCT01778231|"~     This study aims to investigate genetic and environmental determinants of macular pigment~     (MP) and assess the effects of lutein and zeaxanthin-rich supplements on macular pigment~     levels.~   "
97701|NCT01778218|"~     This study will assess the safety and tolerability of the investigational radiolabeled~     imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG).~     Additionally, the study will determine the specific times to best image the heart using a~     SPECT camera with the investigational imaging agent and compare the images to those taken~     while undergoing the standard rest and exercise/regadenoson testing previously performed to~     detect the presence and severity of Coronary Artery Disease (CAD).~   "
97702|NCT01778205|"~     The recent fall in birth and death rates has led to demographic changes such as low~     fertility and high life expectancy . The WHO reports the median age of the European~     population to be the highest in the world and predicts that the proportion of over-60s in~     will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of~     health and well-being in the ageing population. Longevity with a good quality of life is a~     consequence of the combination of an individual's genes, nutrition, environment, lifestyle~     and medical interventions. There is increasing evidence that research into healthy ageing~     needs to start with early life data to capture all traits and exposures experienced by an~     individual throughout life. Epigenetic imprinting occurs both in utero and during early~     postnatal development. Maternal environmental exposures, including nutritional status, may~     have a permanent effect on the developing foetus by influencing epigenetic profiles and~     leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine~     growth due to poor maternal nutrition during pregnancy increases risk in the offspring of~     developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later~     life. To understand the basic mechanisms and interactions through which the ageing phenotype~     develops, systems involved in key processes of early development must be considered as well~     as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a~     longitudinal study. In the first phase, blood is collected from pregnant women at <12, 15,~     24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle,~     habits and supplement use data are collected at 20 and 32 gestational weeks and on~     nutritional habits at <12GW and at birth. Placental vascular function is assessed at 20 and~     32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution~     and outcome are also recorded. The first phase investigates the association between~     gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy~     outcome. The second phase of the study follows up the children at 7.5 years of age. Growth,~     exercise and nutritional habits as well as environment and cognitive development are~     assessed. The aims are to investigate the association between gene-environment interactions~     associated with healthy development from early pregnancy until 7.5 years of age.~   "
97703|NCT01778192|"~     Adequate bowel cleansing is important for a completeness of colonoscopy and detection of~     colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and~     obscured mucosal visualization resulting in missed lesions.~      Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene~     glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium~     picosulphate with magnesium citrate (SPMC).~      There are rare reports that compare directly conventional polyethylene glycol (PEG) solution~     and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.~      The aim of this study is to compare the efficacy, safety, and tolerability of different~     regimens of SPMC and PEG solution.~   "
97704|NCT01778179|"~     To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy~     when used in the pre- and post-procedure phases for the treatment of solar lentigines on the~     back of the hands and in the prevention of post-inflammatory hyperpigmentation after~     cryotherapy.~   "
97735|NCT01777763|"~     The purpose of this study is to collect pharmacokinetic (PK) information related to how well~     posaconazole tablet is distributed in the body and to determine the safety of this new~     formulation. The study consists of a Phase 1B study that includes participants with~     neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia~     (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML~     or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant~     (HSCT).~   "
103962|NCT01696279|"~     To provide information about the safety and efficacy of lanthanum carbonate in children~     compared to standard treatment.~   "
97705|NCT01778166|"~     Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and~     suppressed immune function, which might be worsened by major elective surgery.Enteral~     nutrition has been emphasized for patients with GI malignancy during the perioperative~     period to accelerate bowel function recovery, and improve nitrogen balance and immune~     response while reducing postoperative complications and hospitalization time.Early enteral~     nutrition(EEN) can promote the postoperative recovery of GI function and has been considered~     to have other advantages such as the reduction of medical cost and maintenance of intestinal~     barrier function. Immunonutrition containing special compounds like omega-3-unsaturated~     fatty acids has been put forward to modulate the immune response and improve the immune~     function in patients with cancer, which may have an better effect on the immune system than~     standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition~     after a resectable GI malignancy surgery are scarce.~      The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN)~     is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune~     function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after~     laparoscopic GI surgery.~   "
97706|NCT01778153|"~     The purpose of this study is to compare the Equinox Personal Coaching exercise training~     method to self-directed exercise training in helping subjects become more fit. Men between~     30 and 44 years of age who exercise on a regular basis and are interested in receiving~     Equinox personal training will be invited to participate. The investigators will enroll 36~     subjects at University of California, Los Angeles (UCLA), the only site. The hypothesis of~     this study is that subjects randomized to the Personal Coaching Method will result in~     significantly greater lean mass accrual than those randomized to self-directed training over~     the 12 weeks of the study.~      Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either~     Coached training or self-training, which they will do for 12 weeks, then complete two End of~     Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean~     body mass measurements, and strength and aerobic performance tests, and will take place at~     Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.~   "
97707|NCT01778140|"~     The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with~     Patient-Specific reminders yields superior performance than that with~     Non-patient-specific reminders in preventing contrast-induced nephropathy.~   "
97708|NCT01778127|"~     Five year survival following a diagnosis of childhood cancer has reached 83%, making long~     term health outcomes among survivors an important concern. The growing population of~     survivors is at an increased risk of physical inactivity and associated adverse health~     outcomes. Regular physical activity is associated with better cardiovascular and~     musculoskeletal health. Despite the known benefits of physical activity, nearly half of all~     childhood cancer survivors do not meet recommended guidelines for physical activity.~      Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a~     rewards-based physical activity intervention delivered via an interactive website among~     young adolescent childhood cancer survivors, aged 11 through 14 years, will increase~     physical activity levels and improve cardiovascular and musculoskeletal health. The~     investigators also want to learn if this rewards-based intervention is effective. To achieve~     this goal the investigators have designed a three-arm prospective, randomized study with two~     reward-based intervention groups and a control group.~   "
97709|NCT01778114|"~     The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice~     are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in~     orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2~     supplements.~   "
97710|NCT01778101|"~     This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants~     with gastroesophageal reflux documented by 24hr pH impedance monitoring~   "
97711|NCT01778088|"~     The purpose of this study is to determine the recommended dosing of I-131-CLR1404, a~     radiolabeled therapy compound, for treating subjects with glioma.~      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the~     study will be conducted in three phases, dosimetric, therapy, and follow-up. In the~     dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole~     body imaging on on the day of infusion and on post-infusion days 2, 3, and 7 for assessment~     of biodistribution and tumor uptake of I-131-CLR1404. If normal and expected biodistribution~     are demonstrated, the subject will begin the therapy phase. In the therapy phase, the~     subjects will receive a dose based on body surface area and may receive additional doses if~     they meet dosing criteria. After the last treatment dose, subjects will enter the follow-up~     phase and will be followed monthly.~      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to~     injection of the dosimetric dose, and continuing for 14 days after the administration of the~     therapy dose.~   "
97712|NCT01778075|"~     The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET~     extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current~     marketed ULTRACET ER tablet, in healthy participants under fasted condition.~   "
97713|NCT01778062|"~     This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients~     with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.~   "
97714|NCT01778049|"~     The objective of the study is to investigate the efficacy, safety and tolerability of~     linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM~     patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The~     primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study~     is designed to show superiority of the combination of empagliflozin and linagliptin over~     empagliflozin alone.~   "
97715|NCT01778036|"~     The primary purpose of this study is to investigate if there is altered motor control of~     head and neck in chronic neck pain patients compared with healthy persons. In addition,~     associations between neck pain, motor control, disability and function, and clinical~     symptoms will be studied in patients following physiotherapy treatment in primary health~     care.~   "
97716|NCT01778023|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and~     safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature~     in Korea.~   "
106789|NCT01659138|"~     Primary Objective:~      To assess the efficacy of SAR339658~      Secondary Objective:~      To assess the safety of SAR339658~   "
97717|NCT01778010|"~     Treatment for cocaine dependence is characterized by high rates of relapse, yet the factors~     influencing the likelihood of relapse are poorly understood. Exposure to cocaine, stress and~     cocaine-related cues increase cocaine craving, and genetic polymorphisms in the dopamine D4~     receptor subtype (DRD4) influence the effects of cues and drug exposure on ratings of~     craving. However, craving does not robustly predict drug use or relapse. There are currently~     no data characterizing the interaction between DRD4 polymorphisms, cues and cocaine exposure~     on actual cocaine taking, i.e., cocaine self-administration. Incorporating measures of~     relapse into our established laboratory model is an important objective for medications~     development because models of cocaine self-administration have predictive validity in~     screening medications for cocaine dependence. Aim 1: Refine our cocaine self-administration~     procedures to include measures of relapse. The model is guided by hypotheses supported by~     pilot data: The likelihood of relapse and the quantity of cocaine self-administered~     following relapse will vary as a function of (1) the cost of cocaine, (2) the presence of~     contextual cues associated with cocaine-taking, and (3) noncontingent cocaine administration~     (i.e., 'priming'). Aim 2: Determine the influence of DRD4 polymorphisms on cue- and~     cocaine-induced relapse. Data with alcohol have demonstrated that individuals heterozygous~     or homozygous for 7 or more allele repeats (DRD4L) show increased cue- and alcohol-induced~     craving and greater relapse clinically than those with fewer than 7 allele repeats (DRD4 S).~     We hypothesize that cocaine-dependent DRD4 L volunteers will show greater cue- and~     prime-induced relapse compared to the DRD4 S group. Aim 3: Test the effects of modafinil on~     measures of cocaine relapse as a function of DRD4 polymorphisms. We hypothesize that~     modafinil will: (1) decrease the effect of both cues and a cocaine prime on the likelihood~     of relapse compared to placebo, (2) decrease the amount of cocaine self-administered if~     cocaine use is initiated, and (3) be more effective decreasing cue-and cocaine-induced~     relapse in the DRD4 L group than the DRD4 S group.~      This study will provide valuable information about the interaction between genetic~     variability, modafinil and environmental factors believed to increase cocaine relapse.~   "
97718|NCT01777997|"~     This study is being done with people who are infected with HIV, but do not show any signs of~     having HIV. They are also feeling well without taking HIV medication and have low or~     undetectable levels of the virus in the blood. The purpose of this study is to see if taking~     HIV medication (antiretroviral therapy [ART]) will reduce immune activation (a signal that~     the body is fighting an infection) in people who have HIV, but do not show symptoms. Also~     this study will help determine how safe the drug is and how well people react to the drug.~      For this study, the following antiretroviral therapy (ART) will be provided in the form of a~     single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir~     disoproxil fumarate (FTC/RPV/TDF). These drugs are combined as one tablet which is approved~     by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV~     medication provided is one of the recommended treatments for HIV, including people with low~     viral loads (how much HIV you have in your body) who are taking HIV drugs for the first~     time. The risks seen with this HIV medication are the same that one would encounter when~     taking these drugs outside of the study.~   "
97719|NCT01777984|"~     The purpose of this study is to determine the relationship among the body fat distribution,~     especially the visceral fat, in patients with age-related macular degeneration in comparison~     to patients with a normal fundus.~   "
97720|NCT01777971|"~     Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a~     frequent complication of cirrhosis that is associated with significant morbidity and poor~     quality of life. Large-volume ascites has been associated with impaired pulmonary function.~     In a previous study, the presence and severity of ascites were determined to be significant~     determinants of fatigue.~      In this study, we will determine whether large-volume ascites contributes to fatigue by~     assessing the response to drainage of ascites by means of a procedure called large-volume~     paracentesis. We hypothesize that treatment of ascites with a single large-volume~     paracentesis leads to decreased fatigue and improved quality of life and that this~     improvement is associated with improved sleep pattern.~      20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites~     fluid by large-volume paracenteses will be recruited for the study. All patients will~     undergo a complete clinical and physical examination for liver function, including blood~     tests. Hepatic encephalopathy, a change in mental status associated with liver dysfunction,~     will be assessed by obtaining historical data and by means of simple bedside~     neuropsychological examinations.~      Study visits will take place on two consecutive days, with each visit lasting approximately~     2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete~     standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a~     physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be~     performed 1 day after the procedure. Statistical analysis will then be performed to~     determine the effect of the paracentesis on the various clinical assessments.~   "
97721|NCT01777958|"~     This observational study will evaluate the efficacy, safety and patient reported quality of~     life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin~     (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally~     recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy.~     Additionally, information on selection criteria of breast cancer patients treated first-line~     with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and~     analyzed. Data will be collected from eligible patients for up to 20 months of treatment and~     24 months of follow-up.~   "
97722|NCT01777945|"~     This multicenter observational study will evaluate the efficacy and safety of Xeloda~     (capecitabine) in combination with docetaxel in first-line therapy in participants with~     HER2-negative metastatic breast cancer. Participants will be followed for approximately 6~     months of treatment.~   "
97723|NCT01777932|"~     This multicenter, single-arm observational study will evaluate the clinical benefits of~     Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients~     with metastatic breast cancer. Patients with metastatic breast cancer who have started~     Avastin treatment within 6 months prior to study start will also be eligible. Data will be~     collected from patients for up to 5 years.~   "
97736|NCT01777750|"~     The primary goal in the treatment of acute myocardial infarction is to reperfuse the~     ischemic myocardium to reduce infarct size. Animal data and human data suggest that~     whole-body cooling to temperatures below 35°C before revascularisation can additionally~     reduce infarct size and therefore improves outcome in these patients.~      The purpose of the study is to determine if a combined cooling strategy started in the~     out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.~   "
97737|NCT01777737|"~     First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which~     causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.~      Cotrimoxazole may improve the clinical course of the disease through eradication of~     Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of~     alveolar macrophages and producing alterations in the surfactant system which favours the~     persistent activation of the inflammatory response and the development of pulmonary~     fibrosis.~   "
98024|NCT01773993|"~     To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients~     related to their appropriate use in daily practice.~   "
97724|NCT01777919|"~     Glioblastoma multiform (GBM) is the most common malignant primary brain tumor in adults.~     Despite maximal treatment tumor relapse occurs regularly accompanied by unfavourable~     prognosis. Among other reasons, it is believed that this could be in part due to the~     existence of the so-called tumor stem cells (TSCs), a cellular subfraction within GBM which~     escape therapy by being highly resistant to irradiation and chemotherapy and thus~     constituting the source of tumor recurrence.~      GBM, like many other cancers, show a sub-population of aldehyde dehydrogenase (ALDH)~     overexpressing TSCs. More specifically, ALDH1A1, a cytoplasmatic isoform of ALDH, proved to~     be a novel stem cell marker in human GBM. In addition, ALDH1A1 has been shown to be a~     mediator for resistance of GBM to temozolomide (TMZ) and a reliable predictor of clinical~     outcome; prognosis of patients with a high level of ALDH1A1 expression was poor compared~     with that of patients with low levels. Consequently, ALDH1A1 may serve as a potential target~     to improve treatment of human GBM through inhibition of the enzyme.~      Disulfiram (DSF) has been used for more than sixty years in the treatment of chronic~     alcoholism because of the unpleasant symptoms it provokes after ethanol intake. The~     underlying mechanism is believed to be the accumulation of acetaldehyde in the blood, due to~     inhibition of the liver ALDHs. Actually, DSF is a strong inhibitor of ALDH1A1 and relatively~     non-toxic at therapeutic (for chronic alcoholism) doses that can penetrate the blood-brain~     barrier. In addition, DSF has been shown to be cytotoxic on GBM stem-like cells, inhibiting~     the growth of TMZ resistant GBM cells and blocking self-renewal by ~100% , while it has been~     identified as an inhibitor of human GBM stem cells in high-throughput chemical screens.~     Interestingly, a number of these actions were copper-dependent.~      In the current Phase II clinical trial, DSF/copper combination will be tested as an~     adjunctive and concurrent chemotherapy in the treatment of newly diagnosed GBM. According to~     our hypothesis, initiation of DSF chemotherapy after the resection of the tumor and before~     the introduction of the standard radio-chemotherapy will inhibit ALDH1A1 of GBM TSCs making~     them more susceptible to radio-chemotherapy and possibly reducing the recurrence rate of~     GBM. On the other hand, the addition of copper will probably enhance the cytotoxic effects~     of DSF possibly through augmentation of its pro-apoptotic and proteasomal inhibitory~     actions.~   "
97725|NCT01777906|"~     Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps.~     Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary~     medical management to prevent continued growth. More recently high dose topical nasal~     steroid sprays are used. It is thought that the higher dose will penetrate the sinus~     cavities at an increased dose and will allow for greater control of polyp growth. Safety~     studies have been performed which have shown no suppression of the pituitary axis with long~     term high dose topical steroid or changes in intraocular pressure. However, studies in~     efficacy are limited despite their widespread use. The objective of this study will be to~     compare the effectiveness of two topical nasal steroid sprays in patients with recurrent~     nasal polyps.~   "
97726|NCT01777893|"~     Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is~     mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been~     initiated to find out the most effective lifestyle-components (diet and physical activity)~     in the prevention of Type-2 diabetes. The project consists of a randomized~     lifestyle-intervention with the more specific aim to determine the preventative impact of a~     high-protein and low-GI diet in combination with moderate or high intensity physical~     activity compared with a moderate-protein and moderate GI diet in combination with the same~     activity levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children,~     young and older adults.~      The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain,~     Netherlands, UK) and Australia and New Zealand.~      A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children~     and adolescents aged 10—18 y) will be recruited. All adult participants are first treated by~     a low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and~     adolescents are treated separately with a conventional weight-reduction diet, with-out a~     specific aim for absolute weight loss.~      The adult participants are randomized into two different diet interventions and two exercise~     interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by~     weight-maintenance (prevention of relapse in reduced body weight) and by independent~     metabolic effects of diet and physical activity.~      The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3~     years (156 weeks) according to diet (high protein/low-GI versus moderate~     protein/moderate-GI, adjusted for physical activity), based on a 75 g oral glucose tolerance~     test and/or HbA1c.~      For children and adolescents:~      Change in insulin resistance at 2 years after randomization to high protein versus moderate~     protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as~     well as physiological improvement of health with respect to pre-diabetic characteristics.~      Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2~     diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity~     physical activity will be superior compared to moderate-intensity physical activity.~   "
97727|NCT01777867|"~     The aim of this study is to provide pilot data on the possible gastrointestinal predictors~     of respiratory hyper-responsiveness and how these relate to the clinical sub-types of~     gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.~   "
97728|NCT01777854|"~     The study aims to determine if treating pediatric patients (age 7-17) for four weeks with~     omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is~     that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance~     into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid~     irritation of the surgical wound (tonsil fossas).~      The study will be a prospective double blind randomized study. Participants will be invited~     to participate in the study by giving the study information at the preoperative assessment,~     when the decision is made to have a tonsillectomy performed. If the patient agrees to~     participate in the study, a written consent and child assent will be obtained and the~     patient will be randomly assigned to a treatment versus control group based on the randomly~     assigned participant number.~      The treatment group will then be given a four week course of omeprazole to be taken for the~     four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment~     form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as~     oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the~     postoperative visit or mailed in.~      The pain level and oral intake between the two groups to will be compared to determine if~     antireflux control helps decrease the postoperative pain after tonsillectomy.~   "
97729|NCT01777841|"~     The MC Health Connection Discovery trial is designed to determine if a new health~     information system that delviers interactive care plans (delivered by mobile) to patients~     can impact post-surgical recovery.~   "
97730|NCT01777828|"~     Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic~     bioprostheses through for the treatment of severe degenerative aortic stenosis~     Epidemiological data and the 1-year survival of aortic bioprostheses implanted by~     percutaneous.~   "
97731|NCT01777815|"~     The purpose of this study is to demonstrate the safety and performance of the NeoChord~     DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial~     neochordae in patients with mitral regurgitation.~   "
97732|NCT01777802|"~     Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and~     systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been~     identified, including low intratumor expression of antigens and elevated expression of~     inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce~     necrotic cell death and proinflammatory cytokine production. Stereotactic Body Radiotherapy~     (SBRT) which delivers conformal, tumor-ablating radiation dose may be an effective means of~     conditioning solid tumors favorable to the initiation of robust antitumoral immune~     responses.~   "
122323|NCT01454713|"~     Retrospective data collection of the use of Veritas in breast reconstruction surgery~   "
97742|NCT01777672|"~     Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes~     severe complications. There is no specific treatment for these patients. Impaired swallow~     response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed~     airway protection. Swallow response is initiated by sensory afferent fibers in the~     oropharynx and cerebral cortex reaching the central swallowing pattern generator (CPG) in~     the medulla oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal~     sensory afferent fibers through TRPV1 receptors and electrical stimuli might enhance the~     stimulation of the CPG and speed the swallow response. Long-term treatment of OD will~     improve clinical outcome of stroke patients. Aim: To assess the effect of TRPV1 agonists~     (capsaicin) and that of sensorial pharyngeal electrical stimulation (intrapharyngeal and~     transcutaneous) on VFS signs and swallow response at 3, 6 and 12 months after treatment in~     stroke patients with established OD. To compare the clinical effect of classical~     rehabilitation strategies with that of these new afferent sensorial neurostimulation~     strategies in terms of nutritional status parameters, incidence of aspiration pneumonia~     and/or low respiratory tract infection, quality of life, and mortality. Methods: Clinical~     screening of OD with the volume-viscosity swallow test and assessment by VFS and~     quantitative measurements of swallow response. Randomized controlled trial assessing the~     effect of standard rehabilitation with that of afferent sensorial neurostimulation~     strategies.~   "
97743|NCT01777659|"~     The investigators will test the hypothesis that transcutaneous electrical nerve stimulation~     (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution~     during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary~     Arterial Bypass Graft Surgery (CABG).~   "
97744|NCT01777646|"~     The study will evaluate the safety, tolerability and therapeutic effects of transplantation~     of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting~     neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).~   "
97745|NCT01777633|"~     Although DIPG is not curable, re-irradiation with a modest total dose and short treatment~     time provides good palliation of symptoms, improves quality of life, delays disease~     progression and has minimal and manageable toxicity.~      Treatment plan:~      At progression, full radiological and clinical documentation necessary including a~     neurological exam by a neurologist will be done. Progressive patients will be referred to~     radiotherapy.~      Radiation guidelines:~      30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed.~     Radiation will be done in standard accelerators and according to standard guidelines used in~     treatment for all brain tumor patients.~   "
97746|NCT01777620|"~     This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar~     lines and crow's feet lines).~   "
97747|NCT01777607|"~     The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with~     right ventricular failure.~   "
97748|NCT01777594|"~     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the~     third most common cause of death from cancer. Sorafenib is the only approved therapy for~     treatment of advanced HCC, and there is a need to identify more drugs that are beneficial~     for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in~     which an inactive non-toxic agent is administered to the patient and gets activated within~     the body at specific locations, resulting in a higher concentration of the cytotoxic form at~     a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of~     prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, but not by~     normal cells or blood vessels in normal tissue. It is believed that activation of the~     prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the~     activity and safety of G-202 in patients with hepatocellular carcinoma who have progressed~     after taking sorafenib. The study will evaluate clinical activity and safety of G-202~     administered by intravenous infusion on three consecutive days of a 28-day cycle.~   "
97749|NCT01777581|"~     This study investigates whether milnacipran reduces radicular pain (sciatica) in patients~     with lumbosacral disc disease.~   "
97750|NCT01777568|"~     Our primary objective is to develop a clinical pathway for care of patients having~     colorectal surgery at the Clinic. In particular, the investigators would like to determine~     what intraoperative concentration of oxygen is optimal in our patients.~   "
97751|NCT01777555|"~     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the~     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing~     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the~     clinic.~   "
97752|NCT01777542|"~     Investigators are recruiting children for a clinical trial using the medication recombinant~     human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children~     with Rett syndrome (RTT). While IGF-1 is approved by the Food & Drug Administration (FDA)~     for certain use in children, it is considered an investigational drug in this trial because~     it has not previously been used to treat RTT. Information from this study will help~     determine if IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of~     IGF-1 as a treatment for RTT.~   "
97753|NCT01777529|"~     Whether the lower immunogenicity of the mumps component obtained in clinical studies with~     the MMR in Brazil, due to the multidose presentation. Investigations were made on factors~     that could interfere with immunogenicity of mumps component, as the kits used for the~     immunoassay method, and potency of the vaccine, but no explanation was found. This study~     aimed to investigate the hypothesis that the lower immunogenicity of the mumps component of~     the MMR Bio-Manguinhos vaccine, is due to the multidose presentation.~      The Main objetctive is evaluate the immunogenicity of MMR after one dose in children 12 to~     23 months of life, comparing the performances multidose vial (10 doses per vial of vaccine~     produced in Bio-Manguinhos/Fiocruz through technology transfer from GlaxoSmithKline~     Laboratory - GSK) and single dose vial (1 dose per vial of vaccine produced by GSK).~   "
97755|NCT01777503|"~     The objective of this study is to compare reduced-dose prasugrel and standard dose~     clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS)~     and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial~     will be the one-year composite of (all-cause)death, myocardial infarction, stroke and~     re-hospitalization due to cardiovascular reasons or bleeding.~   "
97756|NCT01777490|"~     The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES),~     offered as a part of a randomized control trial to caregivers of Veterans referred to home~     and community-based long-term care. Of primary interest is to examine whether participating~     in HI-FIVES leads to clinically significant increases in days spent at home for Veterans~     compared to caregivers in usual care. The investigators aim, through the training, to~     decrease the number of days over 12 months post-intervention that Veterans spend in the~     emergency department, hospital, or nursing home. Days spent in these settings reduces the~     Veteran's quality of life and increases health care costs to the VA. The investigators also~     will evaluate whether caregivers in HI-FIVES have clinically significant reductions in~     depressive symptoms post-intervention compared to caregivers in usual care.~   "
97757|NCT01777477|"~     The purpose of this study is to evaluate the safety by defining the maximum tolerated dose~     (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy~     of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the~     treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic~     cancer will be assessed within a translational objective.~        -  Trial with medicinal product~   "
97758|NCT01777464|"~     In order to evaluate the effects a nasal provocation on the activation of different brain~     regions, the investigators want to set up a clinical trial investigating the short-term~     effects of a nasal histamine provocation in healthy volunteers and allergic patients while~     in supine position under the functional MRI device in order to visualize different brain~     regions.~   "
97759|NCT01777451|"~     Whole body MRI will be performed in patients with neurofibromatosis Type 1~      PURPOSE 1:~      To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or~     malignant peripheral nerve sheath tumors. All patients will be scanned two years after the~     baseline whole body MRI to investigate to investigate the changes of total tumor load.~      PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas~      PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath~     tumors and neurofibroma.~      PURPOSE 4 : correlation between histopathology of the surgically resected~     neurofibroma/malignant nerve sheath tumors and MRI findings~   "
97760|NCT01777438|"~     Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an~     allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy~     nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of~     life. Symptom control and overall satisfaction in patients undergoing subcutaneous~     immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been~     investigated so far.~   "
97761|NCT01777425|"~     State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS)~     provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and~     chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can~     alleviate symptoms associated with AR and RS, and most patients with RS benefit from~     endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR~     and CRS continue to experience bothersome symptoms despite adequate treatment. This group~     with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic~     challenge (3).~   "
97762|NCT01777412|"~     This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the~     tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for~     treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO)~     and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added~     to standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma~     exchange (if necessary). The primary outcomes are clinical changes in the Expanded~     Disability Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters~     and safety.~   "
97763|NCT01777386|"~     Tissue expansion methods have been recommended as a means of improving the clinical results~     with perforator flaps but in plastic surgery literature there are few clinical trials~     supporting this opinion. The purposes of this clinical study are to address the~     ''preexpanded perforator flap concept'' by demonstrating a case series of relevant~     reconstructive procedures and to evaluate the perforator vessel changes that happen during~     the expansion periods of various perforator flap donor sites.~   "
97764|NCT01777373|"~     The purpose of this study is to determine whether extension of the conducting airways into~     the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary~     Fibrosis, a disease wherein normal lung structures are destroyed and replaced by~     non-functional scar tissue.~   "
97765|NCT01777360|"~     To determine, from patients presenting severe asthma and an increase in bronchial smooth~     muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY~     should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations,~     and improve respiratory function~   "
97766|NCT01777347|"~     The purpose of this study is to determine whether nebulized hypertonic saline solution~     reduces the admission rate 48 hours after initial treatment in the emergency department,~     when compared to normal saline solution (control).~   "
97767|NCT01777334|"~     The purpose of this 24 week study is to evaluate the spirometric lung function effect~     (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg~     once daily along with safety assessments in subjects with COPD.~   "
97768|NCT01777321|"~     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK~     Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC)~     as compared to intramuscularly (IM) to people 50 years of age and older.~   "
97769|NCT01777308|"~     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a~     booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary~     vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and~     Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate~     the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.~      This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).~   "
97781|NCT01777152|"~     This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the~     efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care~     CHOP in patients with CD30-positive mature T-cell lymphomas.~   "
97770|NCT01777295|"~     This study aims to develop innovative immunological read-outs and new technologies in order~     to further characterise the early immune response and its kinetics as well as the adaptive~     immune responses to adjuvanted vaccines.~      This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults~     vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'~     Adjuvant System.~   "
97771|NCT01777282|"~     This study is designed to examine the long term safety and efficacy of weekly subcutaneously~     injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in~     Japanese subjects with type 2 diabetes mellitus.~   "
97772|NCT01777269|"~     This is an European double-blind, placebo controlled parallel group comparison of DUODART~     (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and~     placebo.~      PRIMARY OBJECTIVE:~      To assess the change in sexual function from baseline to 1 year in sexually active men with~     at least moderate BPH who are treated with DUODART, compared to men treated with placebo .~   "
97773|NCT01777256|"~     This is an adaptive, dose ranging, Phase II study to investigate the relationship between~     repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients~     with active systemic lupus erythematosus (SLE). This study will also investigate the safety~     and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses~     will be conducted. These are to monitor the pharmacodynamic effect and safety following 2~     weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184~     following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry~     criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive~     GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d,~     400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength~     will be administered orally up to 12 weeks.~      Subjects who complete the study will participate in the study for approximately 21 weeks.~   "
97774|NCT01777243|"~     The study will be conducted in two parts. The first (Part A) will be an open label single~     dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5~     milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose~     levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be~     administered at variable doses until the concentration of the serum amyloid P component~     monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions~     about these next dose levels will be made following safety review of the prior subjects'~     data; dose levels may be changed (increased and lowered) and dose levels may be repeated~     depending on the observed safety such that Part A extension study may be performed. In~     addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and~     circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to~     the highest well tolerated dose or the highest allowable dose. Subjects will be closely~     monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including~     organ volume, Elastography and Liver Biopsy if required.~      Part B will be a randomized partially blinded part with the principal objective of assessing~     the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of~     approximately 5 dose groups from Part A. The precise selection of numbers of subjects and~     dose levels will be informed by the results from Part A.~   "
97775|NCT01777230|"~     Objective of the study: To study the concordance of sentinel node (SN) localization between~     preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the~     intra-operative SN procedure for low stage cervical cancer.~      Background: The SN procedure for surgically treated cervical cancer is promising.~     Unfortunately, efficient and direct intra-operative SN localisation, without an extensive~     surgical exploration, remains a challenge even with combined use of patent blue dye en~     technetium-99m (99mTc). Preoperative imaging (= mapping) with 99mTc based SPECT-CT, which is~     increasingly adopted, has partly alleviated this problem. The investigators aim to~     investigate the feasibility of a new SN mapping modality, which visualises the (sentinel)~     lymph nodes using a Magnetic Resonance Imaging (MRI) technique (so called; Magnetic~     Resonance Lymphangiography), and compare it to SPECT-CT.~      Design: Prospective, feasibility type diagnostic study. 40 subjects targeted. Via vaginal~     speculum exam, a specific MRI contrast-agent will be intracervically injected. Subsequently,~     on a wide bore 1.5T MRI system multiplanar imaging is performed, followed by a blinded~     review (experienced radiologist) for bilateral SN localization. Standard care with a~     preoperative SPECT-CT (after intracervical 99mTc administration). A blinded nuclear medicine~     specialist will localize the SN on the SPECT-CT images. Open or (robot-assisted) laparoscopy~     performed for localization of the blue stained and/or 99mTc-hot SN. Excision of the SN with~     freeze sectioning and histological review. Statistical analysis with intrapatient testing~     for concordance of MR Lympangiography and SPECT-CT based SN localization against the~     reference standard: the intra-operative sentinel node procedure.~   "
97776|NCT01777217|"~     The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective~     in treating over-active bladder symptoms during radiation therapy of the prostate.~   "
97777|NCT01777204|"~     Gastrointestinal (GI) complications after renal transplantation are commonly reported as~     side effects of immunosuppressive agents. Despite this, motility disorders have been~     scantily studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors~     designed for a wide range of applications. In clinical practice, their non-invasive and~     radiation free features provide an excellent approach for monitoring of GI transit as~     alternative to scintigraphy and breath tests. The aim of this study is to examine GI transit~     and motility of solids in stable renal transplant recipients to determine the potential~     influence of immunosuppressive therapy on gastrointestinal parameters.~   "
97778|NCT01777191|"~     The purpose of this study is to evaluate the serum concentration of ixekizumab after~     administration using either prefilled syringe or auto-injector in participants with moderate~     to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety~     extension.~   "
97779|NCT01777178|"~     This study will compare acid-base changes during hemodialysis treatments with a standard~     dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that~     limit equilibration of the bicarbonate concentration in a patient's blood with that in the~     dialysate.~   "
97780|NCT01777165|"~     This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney~     injury in patients undergoing high risk cardiac surgery.~   "
97783|NCT01777126|"~     After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a~     delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is~     questionable if nutritional support by routine use of parenteral nutrition (PN) is~     justifiable.~      A non-randomized before-after trial was conducted. Patients treated with an elective regular~     radical cystectomy and without preoperative contra-indications for enteral nutrition were~     eligible. In the control group, PN was initiated immediately after the procedure and~     continued until resumption of diet. In the interventional group, an ONP was implemented. PN~     could be initiated if oral intake was still insufficient after five days. The primary end~     point was the postoperative length of stay.~   "
97784|NCT01777113|"~     Stroke is a global health-care problem that is common, serious and disabling. In most~     countries, stroke is second or third most common cause of death and one of the main causes~     of acquired adult disability. After stroke, patients remain at continued high risk for~     recurrent stroke as well as for myocardial infarction and cardiac death. After completion of~     conventional physical therapy, there are no empiric recommendations and few resources~     promoting regular exercise during the chronic stroke period.Interventions to improve~     cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many~     rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies~     based on neurodevelopmental principles such as the Bobath concept. These standard therapies~     are an insufficient stimulus to increase fitness levels after stroke.~   "
97785|NCT01777100|"~     The appropriate management of postoperative pain is recognized as an important clinical~     challenge with implications beyond humanitarian issues. Evidence shows that effective~     postoperative analgesia is associated with physiological benefits to the patient, shortened~     length of hospital stay and lower rates of in-hospital complications, such as pneumonia,~     delirium and persistent pain after surgery. However, despite the availability of several~     analgesic drugs and strategies the prevention and treatment of postoperative pain is often~     suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous~     infusion for anesthesia for several surgical procedures. Remifentanil has been extensively~     advocated as a means to provide quick patient awakening in the immediate postoperative~     period with a very low risk of respiratory depression. Yet it does not provide residual~     analgesia and postoperative pain is a major concern. In order to overcome this limitation,~     practicing anesthesiologists frequently give patients a single dose of Sufentanil, a long~     acting opioid, during the induction of anesthesia where Remifentanil will be used in~     continuous infusion. However the effectiveness of this strategy still lacks evidence from~     controlled clinical trials.~   "
97786|NCT01777087|"~     This study has two purposes: first, to locate and identify the brain activation (the areas~     of the brain) which respond to pain; and second, to look at how brain activation is~     influenced by a person's genetics (the traits they inherited from their parents). A Magnetic~     Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an~     x-ray, but based on different scientific principles) that will be used to determine which~     areas are active. The hypothesis is that the variation in brain activity between people can~     be partially explained by genetic differences. This study consists of an two pain tasks~     applied during a one time visit to the MRI suite. There are no followup visits.~   "
97787|NCT01777074|"~     The present study is conducted in order to assess the acceptability of Hepatitis B~     vaccination in French general practitioners and peadiatricians before and after~     reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are~     planned, first before reimbursement and after reimbursement.~   "
97788|NCT01777061|"~     When evaluating prostate cancer patients for recurrent disease, computed tomography (CT),~     and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph~     nodes, but are not specific as to whether the lymph nodes are malignant or benign.~      While positron emission tomography (PET) utilizing radioactive glucose (FDG) has~     revolutionized staging, restaging, and monitoring response to therapy in many prevalent~     cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma,~     findings with prostate cancer have proven less sensitive because prostate cancer has a lower~     avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the~     cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in~     detecting prostate cancer.~      This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in~     identifying recurrent prostate cancer.~   "
97789|NCT01777048|"~     The overarching aim of the proposed study is to assess whether omega-3 fatty acids~     supplementation can augment the effects of methylphenidate in children with ADHD. The~     investigators hypothesized that omega-3 fatty acids supplementation will be associated with~     improved ADHD symptoms.~   "
97790|NCT01777035|"~     To study all ICU patients with an independent baseline functional status , who experience a~     critical illness requiring intubation and mechanical ventilation evaluating long-term~     cognitive and executive function and long term cost effectiveness in survivors who required~     mechanical ventilation.~   "
97791|NCT01777022|"~     Rates of stillbirth in Scotland are among the highest in resource rich countries. The~     majority of stillbirths occur in normally formed infants, with (retrospective) evidence of~     placental insufficiency being the commonest clinical finding. Maternal perception of~     decreased fetal movements appears to be an early biomarker both of placental insufficiency~     and subsequent stillbirth.~      The study proposed here will test the hypothesis that rates of stillbirth will be reduced by~     introduction of a package of care consisting of strategies for increasing pregnant women's~     awareness of the need for prompt reporting of decreased fetal movements, followed by a~     management plan for identification of placental insufficiency with timely delivery in~     confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar~     package of care in Norway but the efficacy of this intervention (and possible adverse~     effects and implications for service delivery) have not been tested in a randomized trial.~      The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland~     and Ireland will be randomized to the timing of introduction of the care package. Outcomes~     (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's~     detailed routinely collected maternity data, allowing the investigators to robustly test the~     hypothesis. A nested qualitative study will examine the acceptability of the intervention to~     patients and health care providers and identify process issues (barriers to implementation).~   "
97794|NCT01776983|"~     Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected~     skin by Siascopy. Immunocompromised patients (for more than seven years) compared to~     immunocompetent patients.~        -  Trial in the field of transplantation / xenotransplantation~   "
97795|NCT01776970|"~     The clinical primary hypothesis is that there will be a difference between a Cannabis Sativa~     extract and placebo in their effect on spasticity in Motor Neuron Disease (MND) patients~     with signs of involvement of the upper motor neuron (UMN) resulting in disabling spasticity.~      Secondary goals of the study are to evidence of improvement in other symptoms (in particular~     pain), and to show favourable trends on functionality measures. Finally, cannabis based drug~     safety and tolerability will be studied through vital parameters (including weight and~     pulmonary function) measurement, and analyzing ALS function rating scale progression slope~     hopefully, showing a slowing of the functional values decrease, owing to cannabis~     neuroprotective effects)~   "
97796|NCT01776957|"~     The rate of repeat abortions will be lowest in those women who choose immediate insertion of~     an IUD post-abortion versus those who immediately choose oral contraceptive pills and those~     who indicate all other contraceptive choices including no contraception The provision by the~     health system of IUDs for immediate insertion will result in the lowest health system costs.~   "
97797|NCT01776944|"~     High prevalence of obesity in children has increased associated complications such as type 2~     diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that~     restricts caloric intake by estimating the resting and total daily energy~     expenditures.Estimation of energy needs is most commonly done using predictive equations.~     Reliable and valid energy requirements can be obtained using a traditional metabolic system,~     however this is an expensive option. Handheld indirect calorimeters may be a good~     alternative to measure energy needs. Several studies have been conducted to determine the~     validity and accuracy of handheld calorimeters in adults and health children, however, to~     the best of our knowledge, there are no such studies in the overweight and obese pediatric~     population.~      The purpose of this study is to validate a handheld indirect calorimeter against a~     traditional metabolic system in overweight and obese children.~      If handheld calorimeters can accurately measure resting energy expenditure in overweight and~     obese adolescents, dietitians will have an opportunity to tailor pediatric weight management~     interventions based on parameters that are unique to each individual.~   "
97798|NCT01776931|"~     Amino acids are building blocks of protein in our body. It is important that pregnant women~     eat adequate amount of protein/amino acids to ensure healthy growth and development of the~     fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat)~     and not much in plant foods such as wheat. Currently , it is not known how much lysine is~     needed to eat during pregnancy.~      Current Dietary Reference Intake recommendations for amino acid requirements are based on~     non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators~     knowledge, there is no scientific information regarding the amount of lysine needed at~     different stages of pregnancy.~      The investigators hypothesize that current recommendations for lysine intake in pregnant~     women are underestimated. The investigators also hypothesize that the lysine requirements~     will be greater during the later stages of pregnancy, compared to early stages.~      The purpose of this study is to determine lysine requirements in healthy pregnant women~     19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator~     amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks~     last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.~   "
97799|NCT01776918|"~     Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to~     disruptions in energy producing pathways in our body. Enough energy or calories must be~     given in the diet to ensure normal growth and development. Currently, energy needs for~     patients with metabolic and mitochondrial diseases are not measured, but is estimated using~     a mathematical equation based on healthy children. This may lead to under feeding or~     overfeeding of calories, and has negative nutritional implications.~      The clinical standard for measuring energy needs is the use of indirect calorimeter.The~     indirect calorimeter takes individualized measurements for each patient and therefore will~     enable dietitians and clinicians to provide sufficient calories in the diet to better manage~     the disease and promote normal growth and development.~      We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria)~     and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation~     etc.).~      The objective of this preliminary study is to measure resting energy expenditure in children~     living with metabolic and mitochondrial conditions and data obtained will be used to~     generate future hypothesis and will form a basis for future studies.~   "
97800|NCT01776905|"~     The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry~     (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of~     melanoma patients in vivo, in real time, and do so at detection limits at least one order of~     magnitude below the detection limits of currently existing ex vivo methods.~   "
97801|NCT01776892|"~     Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily~     activities. Treatment traditionally involves cutting out diseased tissue, however this can~     cause damage to important structures in the hand and results in large scars.~      Needle aponeurotomy and collagenase injections are newer treatments that are thought to be~     safer. These treatments allow quicker return to function. One drawback is that Dupuytren's~     deformity may return more quickly than when all diseased tissue is surgically cut out.~      This research study is designed to compare the effectiveness of needle aponeurotomy and~     collagenase injection for Dupuytren's disease. This study will determine which procedure~     gives the best results- either needle aponeurotomy, collagenase injection, or both~     procedures in combination. Participants will be evaluated to see how they do in the long~     term.~   "
97802|NCT01776879|"~     This study will examine speech intelligibility of early parkinson's disease (PD) patients,~     early PD patients and first degree relatives. The investigators hypothesis that advanced PD~     patients will present decreased speech intelligibility more than early PD patients. Speech~     intelligibility of first degree relatives will be normal.~   "
97803|NCT01776866|"~     The investigators hypothesized that dual-axis rotational coronary angiography was~     non-inferior to standard coronary angiography with respect to diagnosis of coronary artery~     disease.~   "
97804|NCT01776853|"~     The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS)~     who also report bloating are more likely to report clinically important gastrointestinal~     symptoms after consuming fructose or fructans than after consuming glucose. We will also use~     MRI imaging to investigate the mechanisms by which those symptoms might be caused.~      We will also study a parallel group of age and gender frequency matched healthy volunteers~     to provide descriptive statistics on a likely reference range for the healthy population.~      Irritable Bowel Syndrome (IBS) is a common chronic condition, the main features of which are~     pain in the abdomen, an erratic bowel habit and sometimes bloating. Recent research has~     found that certain carbohydrates (sugars) in the diet can cause symptoms such as discomfort,~     bloating and wind/gas in people with IBS. These sugars are not well digested in the small~     bowel. They move to the colon (large bowel) where bacteria act on them by fermentation,~     producing gas. Some of the gas is absorbed and breathed out through the lungs, where we can~     measure it. The rest is released as flatulence/ wind, or occasionally belching. People~     without IBS rarely get symptoms after consuming these sugars. We want to find out what is~     different in IBS sufferers.~      We will study fructose and fructans, sugars found in fruit, vegetables and wheat. Fructose~     draws water into the small bowel but fructans do not so we can compare effects on the small~     bowel and colon. Participants will attend three times, and on each occasion consume a drink~     containing either fructose, fructans, or glucose - a sugar that does not cause symptoms.~     Neither they nor the investigators present will know which drink is which. They will record~     their symptoms over the next 5 hours. We will observe how many report a clinically important~     increase in symptoms.~      To look at what is happening in the bowel we will use a technique called Magnetic Resonance~     Imaging (MRI). We want to see if more gas, or water, builds up in people with IBS than in~     healthy volunteers. We will also measure the amount of hydrogen released in the breath to~     see if this is could be a simple bedside test that agrees with the MRI findings~      Finding differences between the response of participants to fructose, fructans and glucose~     could change the way we advise patients, and could lead to the use of MRI as a test for IBS.~   "
97805|NCT01776840|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in~     combination with bendamustine and rituximab in patients 65 years of age or older with newly~     diagnosed mantle cell lymphoma.~   "
97806|NCT01776827|"~     To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular~     dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh at a University Hospital.~   "
97807|NCT01776814|"~     Chronic hepatitis B virus infection is an important cause of morbidity and mortality.~     Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B~     virus infection. In this study, the investigators will try to make comparison between~     Entecavir and Tenofovir and investigate the efficacy.~   "
97808|NCT01776801|"~     The purpose of this project is to determine during moderate rise of intracranial pressure~     (ICP) in awake patient, the change in autonomic function and its influence on cerebral and~     systemic haemodynamics.~   "
97809|NCT01776788|"~     The randomized, controlled trial is to investigate and evaluate the effects of short-term~     continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell~     function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2~     diabetic patients.~   "
97810|NCT01776775|"~     Postoperative seroma formation is one of the most common complications after ventral hernia~     repair with mesh. Although some seromas may not have clinical impact postoperative seroma~     formation often causes pain and discomfort and may even compromise wound healing. Abdominal~     binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are~     commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain~     and discomfort after operation. The primary aim of the present study is to investigate the~     effect of postoperative abdominal binders after laparoscopic incisional hernia repair on~     postoperative pain, discomfort and quality of life. Secondary, we register seroma formation.~     A randomized, controlled, investigator-blinded study supplemented with blinded statistical~     analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to~     abdominal binder or no abdominal binder (controls). The abdominal binder is worn from~     immediately after the operation and continuously for 7 days and nights. All patients have a~     standardized operation with standardized intra- and postoperative medication regimen.~     Endpoints measurements are clinically detectable seroma formation scored with seroma~     classification system buý S. Morales-Conde, pain scored with self-registrations with VAS,~     and quality of life scored with EQ-5D, recurrence and other complications are also~     registered. Patients are followed until 90 days after the operation.~   "
97811|NCT01776762|"~     Based on an established Follow-home-programme offered at discharge from hospital the aim of~     this study is to test a model of how nutritional intervention in elderly patients can be~     systematized and quality assured in the transition between sectors. Furthermore the aim is~     to demonstrate that this model has a positive effect on the functioning and well-being of~     the elderly patient.~      The purpose of the Follow-home-programme is to facilitate the transition of the elderly~     patient between hospital and private home in order to follow-up on any medical, nursing- or~     retraining-related intervention necessary to the rehabilitation of the patient. However this~     offer does not focus on nutrition in particular. This is a problem as many elderly patients~     are known to develop a poor nutritional status due to low appetite, disease etc. Our~     hypothesis is that adding a systematic nutritional focus to the Follow-home intervention~     programme will promote the rehabilitation of the elderly patient further.~      The nutritional intervention in our study will focus on improving energy- and protein intake~     and we will measure the effect on the patient's functional abilities, quality of life and~     rate of hospital readmissions. The intervention model will be based on individualized~     nutritional counselling by a registered dietician in the patients home.~   "
97812|NCT01776749|"~     Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of~     chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal~     Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients~     mostly have dominant leg pain, however a significant percentage of FBSS patients has a more~     pronounced back pain and are commonly excluded from SCS as it is often inadequate in~     relieving both the back and leg pain components. Recently some reports showed the benefit of~     subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been~     confirmed by a feasibility study performed by our group. The aim of the randomized~     controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for~     whom SCS gives an inadequate back pain relief.~      Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low~     back pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS~     alone.~   "
97825|NCT01776580|"~     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual~     dysfunction, and analyzing the association will be helpful to identify the indication of~     proper management. Therefore, the aim of this study is to identify the above associations by~     perineal sonography.~   "
107019|NCT01656096|"~     The purpose of this study is to examine the benefit of renal sympathetic denervation in~     patients with mild refractory hypertension~   "
97813|NCT01776736|"~     For AIS, the caring of patients with spinal deformities has a long and varied history.~     Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead~     to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the~     curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of~     orthoses treatment on patients and its poor compliance has been a well-recognised problem.~     Some orthotic research studies indicate that early intervention of spinal deformities is~     particularly desirable. Taking into consideration current clinical practices, if the curve~     is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity~     during the age of 10-16 at puberty, treatment is nothing more than just observation.~      This project aims to combine clinical experience with textile and materials sciences to~     research and develop a posture correction girdle for adolescents with early scoliosis. As a~     result, this will reduce the future likelihood of brace wear or surgery.~      In this study, the eligible subjects will be given tailor-made posture correction girdles to~     wear it 8 hours daily. Monitoring and observation will be provided during the six months~     girdling period. Data will be collected before and after the girdling by X-ray radiograph~     for analysis, in order to comparison the spine curvature condition. Locomotion of the~     subject with and without wearing the posture correction girdle will also be reference.~   "
97814|NCT01776723|"~     The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML)~     with a study drug [ruxolitinib] can improve outcomes of patients with CMML. The first step~     of the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has~     already been studied in a number of patients with different bone marrow diseases and is~     approved for the treatment of a disease called Myelofibrosis; however, it is not approved~     for treatment of CMML. It is given orally (by mouth). Most people tolerate it well but the~     tolerability has not been determined in patients with CMML. We will be testing different~     doses to determine how much of the medication people can tolerate (bear) before they develop~     side effects.~   "
97815|NCT01776710|"~     A primary therapeutic goal for patients with intermittent claudication (IC) is to regain~     lost physical function through exercise rehabilitation. Supervised exercise programmes can~     markedly improve walking capacity, but these are resource intensive, National Health Service~     provision is limited, and patients cite accessing services as a barrier to participation.~      Increasing walking activity via a structured education programme might be a pragmatic~     solution for improving walking capacity, health and wellbeing in patients with IC; however,~     further research is needed to substantiate this. Hence, the aim of this project is to~     develop a pragmatic education programme to increase walking in these patients and to collect~     data on its feasibility to inform the development of a definitive trial investigating~     clinical and cost effectiveness.~      Focus groups will be conducted to inform the development of the education programme.~     Programme components will be theoretically-underpinned and evidence-based. The development~     of the programme will be an iterative process involving pilot work, feedback, evaluation,~     and revision. The programme will then be assessed in a randomised controlled pilot study~     with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain~     preliminary data of its impact on important outcomes (daily steps/physical activity, walking~     capacity, quality of life, illness perceptions).~   "
97816|NCT01776697|"~     A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic~     characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as~     a pelubiprofen 90 mg) tablet QD in healthy subjects.~   "
97817|NCT01776684|"~     To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer~     harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR~     method.~   "
97818|NCT01776671|"~     Phantom limb pain (PLP) is a common disorder reported by the patients who undergo~     amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used.~     The purpose of this study is to evaluate the accuracy and efficacy achieved in using of~     extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and~     improving clinical outcomes postoperatively.~   "
97819|NCT01776658|"~     The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in~     patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability~     are also evaluated.~   "
97820|NCT01776645|"~     The purpose of this study is to determine whether compassion training will improve the~     physical and psychological well-being of patients with chronic pain. The investigators also~     want to determine whether any benefit of compassion training in the patients spreads to~     significant others with whom the patient has a close relationship.~   "
97821|NCT01776632|"~     The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas~     likely contributes to the high rates of cancer and other chronic diseases in this~     population. The goals of the current study, based largely upon the core principles of the~     Social Ecological Model, are to design, implement, and evaluate an innovative multi-level~     intervention promoting physical activity among churchgoing Latinas.~      The evidenced-based intervention targets three tiers of environmental influences (i.e.,~     church, immediate neighborhood surrounding the church, and community) on activity, as well~     as MVPA-related personal factors (i.e.., intra/interpersonal, cultural, and perceived~     environmental variables). The physical activity intervention will be compared with an~     attention-control condition providing health education on cancer prevention and control via~     screening.~      Sixteen churches will be randomly assigned to either the physical activity intervention or~     the attention-control condition. The primary aim of the study is to determine whether a~     multi-level intervention will increase MVPA among Latina churchgoers in the intervention~     condition relative to the attention-control condition.~   "
97822|NCT01776619|"~     Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young~     healthy volunteers toghether with food effect on relative bioavailability of solid~     formulation after single dose.~   "
97823|NCT01776606|"~     This study will evaluate the efficacy and safety of botulinum toxin type A compared to~     placebo control for the treatment of moderate to severe crow's feet lines.~   "
97824|NCT01776593|"~     To identify the bladder diary parameters that are best correlated to VSD.~   "
98040|NCT01773824|"~     To evaluate the effect of a continuous postal and web-based feedback and peer comparison~     system of individual antibiotic prescription rates on the prescription behaviour of primary~     care physicians in Switzerland.~   "
97826|NCT01776567|"~     The purpose of the trial is to directly compare the Cobalt Chromium platform~     everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform~     everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position~     with the heart blood vessel and extent of tissue coverage (at 6 months) using optical~     coherence tomography.~      Hypotheses:~        1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on~          stent apposition measured using OCT.~        2. Stent design and alloy composition have a direct influence on radial support and~          scaffold shrinkage.~   "
97827|NCT01776554|"~     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived~     influenza vaccine in children.~   "
97828|NCT01776541|"~     Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived~     Influenza Vaccine in Adult Subjects.~   "
97829|NCT01776528|"~     The purpose of this study is to determine the safety and tolerability of NGM282, both single~     dose and multiple doses, in normal healthy adult participants.~   "
97830|NCT01776515|"~     The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen~     SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.~   "
97831|NCT01776502|"~     The purpose of this study is to evaluate the evolution of the non specific symptoms for 116~     patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery.~     A clinical score predicting clinical improvement at one year will be created.~   "
97832|NCT01776489|"~     Food allergies represent an increasing health concern in the industrialized countries and~     especially affect pediatric patients. In this population adverse reactions against food~     compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical~     markers predicting disease severity and symptoms are missing to date.~      Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P),~     play an essential role in allergy. It was reported that asthmatic patients have higher S1P~     levels in bronchiallavage fluids after allergen challenge. First experimental studies~     revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in~     our recent mouse study that S1P homeostasis is pivotal for food allergy induction and~     effector cell response. Therefore, it is the aim of the presented pilot project to evaluate~     whether S1P serum titers are altered in food allergic children and if the S1P levels~     correlate with the outcome of anaphylaxis during double blind placebo controlled food~     challenges (DBPCFCs).~   "
97833|NCT01776476|"~     The purpose of this study is to find out if giving certain amino acids to critically injured~     patients can improve their condition or recovery, and lower their blood sugar and insulin~     needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in~     this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine.~     Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA)~     for intravenous use. However, it is approved by many countries in Europe, Asia and South~     America. Several studies suggest that giving glutamine has certain benefits in patients who~     need intensive care. In a study done at Emory University Medical Center using the same dose~     of glutamine, the number of hospital infections was lower in patients who had had cardiac,~     blood vessel or intestinal surgery compared to similar patients who received standard~     feedings without glutamine. No side effects were thought to be due to giving glutamine in~     that small study. This study is only being done at Vanderbilt University. The investigators~     plan to enroll 24 patients in the Trauma ICU over the next 12 months.~   "
97834|NCT01776463|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics~     (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.~   "
97835|NCT01776450|"~     To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of~     the clinical protocol through compassionate use.~   "
97836|NCT01776437|"~     This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on~     the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male~     subjects.~   "
97837|NCT01776424|"~     The primary purpose of this study is to evaluate whether treatment with rivaroxaban and~     aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks,~     stroke or cardiovascular death in patients with coronary or peripheral artery disease.~   "
97838|NCT01776411|"~     Phase I portion:~      To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma~     patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day)~     for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics.~      Phase II portion:~      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen~     determined in the phase I portion. The primary efficacy endpoint shall be objective response~     rate (ORR).~   "
97839|NCT01776398|"~     The purpose of this study is to obtain biologic materials from the blood, airways and/or~     urine of normal individuals and individuals with lung disease. The normal are used to~     establish a set of normal ranges for various parameters. These provide control information~     when compared to individuals with various pulmonary diseases, and will help in understanding~     of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that~     the pathologic morphological changes in the airway epithelium must be preceded by changes in~     the gene expression pattern of the airway epithelium and potentially in macrophages.~   "
97870|NCT01775995|"~     Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It~     is often refractory to treatment, with patients requiring long-term opioid therapy.~     Mindfulness meditation is a promising treatment for chronic pain, mental health and~     addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of~     care for CLBP, it may produce additive benefits. The goal of this randomized controlled~     trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral~     intervention to improve the health of adults with opioid-treated CLBP. This RCT will test~     the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual~     care), compared to those in a wait-list control group (usual care alone), will improve~     health-related quality of life (primary outcomes: pain severity and physical function) and~     reduce opioid medication use (secondary outcome). In addition, they will also decrease~     alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.~   "
132078|NCT01326390|"~     Impact on contrast dose or total volume of contrast required to effectively treat the~     targeted tumor.~   "
97840|NCT01776385|"~     Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early~     diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare~     distant metastases. There is now a sizable body of evidence that metastases could develop~     from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive~     and specific detection of CTC in blood is considered as a potentially relevant predictive~     biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has~     not yet been evaluated.~      Indeed, the main goal for preoperative detection of CTC is to identify patients with high~     risk of recurrence after surgery, in order to perform more adapted therapeutic strategy.~     Despite several studies reported about CTC detection, methodological aspects concerning~     sensitivity, specificity and reproducibility have prevented a clear appraisal of their~     clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic~     value of CTC in MPM by a double approach. In our setting, cytopathological analysis of~     circulating non hematological cells (CNHC), of epithelial origin, isolated according to~     their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic~     selection, identification and enumeration of circulating epithelial cells in peripheral~     blood (CellSearch method) is considered a promising approach.~   "
97841|NCT01776372|"~     The chest cavity contains a small amount of fluid (pleural effusion). In normal~     circumstances this fluid is kept in balance. When surgery is performed on the lung, there~     can be accumulation of more fluid due to many causes. In order to drain this additional~     amount of pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection~     procedure. The investigators are attempting to reduce the amount of pleural fluid production~     and formation by using a more balanced thoracic drainage system, which adjusts the amount of~     suction depending on the needs of the patient. That way, the amount of inflammation in the~     thoracic cage might be smaller, and hence less fluid will be formed. By this, the~     investigators are hoping that the chest tubes can be removed earlier, and the patients can~     be discharged faster and will potentially have a lower rate of re-admission to the hospital~     after surgery due to problems related to the fluid in the thoracic cage.~   "
97842|NCT01776359|"~     A four week intervention will take place with the participants. They will undergo 6 days a~     week of high intensity training. They will also be at a 40% energy deficiency. One group~     will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our~     thesis that the participants with the higher protein will retain more lean mass.~   "
97843|NCT01776346|"~     The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more~     effective targeted screening strategies and treatment options for Barrett's esophagus and~     esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a~     platform. Examples of analyses could include identifying genetic determinants and biomarkers~     that predict BE, progression of BE to EAC, as well as the response to therapies.~   "
97844|NCT01776333|"~     Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted~     patients.~   "
97845|NCT01776320|"~     A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of~     treatment. Patients with erectile problems will be given the approved drug Vitaros to treat~     their condition. They will be given forms and questionnaires to complete. The information~     collected will be used to assess the effectiveness, safety and the satisfaction levels with~     this drug.~   "
97846|NCT01776307|"~     This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab,~     panitumumab or capecitabine in patients with advanced colorectal cancer.~   "
97847|NCT01776294|"~     Student Investigator = Thakkallapalli Zeeshan Muzahid. The study aims to assess the~     prevalence of prehypertension among medical students of Andhra Medical College,~     Visakhapatnam, India and its association with other cardiovascular risk factors - overweight~     /obesity, diabetes, lipid profile.~   "
97848|NCT01776281|"~     - Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of~     deaths among premature and low birth weight LBW infants. Even if the infants are born in~     facilities, incidences of cold stress are possible due to insufficient resources, space and~     incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo~     Mother Care is a well-known intervention to address the issues related to preterm births,~     such as hypothermia, infection and prolong hospitalization.Besides significant outcome of~     KMC interventions for preterm infants, no interventional study has been found in literature~     in Pakistani context. Looking at the potential benefits of KMC in reducing the related~     complications of prematurity, the study aims to identify the effectiveness of KMC among~     preterm and LBW infants born in secondary hospital of Aga khan University hospitals.~      Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm~     and LBW infants as compared to the usual care.~      Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome~     among experimental and control group.~      Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of~     suspected infections during hospitalization.~      Hypothesis II Ha: There is a difference in length of stay among experimental group and~     control group.~      Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four~     weeks.~      Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and~     control after discharge from hospital.~   "
97856|NCT01776177|"~     The primary objective is to assess the clinical effectiveness of long-term omalizumab~     therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to~     compare the pre- and post-treatment clinical characteristics to identify and better~     understand the markers of response to omalizumab.~      To date, there are no established criteria for identifying 'response' to omalizumab therapy.~     Currently, the commonly accepted clinical criterion for omalizumab treatment response is the~     physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most~     clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week~     treatment period and lack the impact of long-term omalizumab therapy.~      Investigators propose multiple approach modules to better assess and identify 'response' and~     to define 'responders' to omalizumab and evaluate the long-term impact in a real-world~     clinical practice. Besides evaluating individual outcome variables, it is important to~     attempt the 'clustering of variables' to further investigate if any baseline clinical~     phenotypes are predictive of better response enabling us to refine the patient population~     who will gain most benefit from therapy.~   "
97849|NCT01776268|"~     Background:~      Infection in preterm infants is a common, costly, and devastating problem frequently causing~     death or sequelae for survivors. An immature immune system underlies the frequency and~     severity of infections in this vulnerable population. The mouth is the site where microbes~     first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva~     kill microbes and improve immune cell function. Low APP levels increase the risk of~     developing infection. Colostrum and human milk reduce the risk of infection. This protective~     effect of human milk may come from supplying or stimulating infant production of APPs. No~     prior investigation has determined the concentration of APPs in saliva or the effect of~     human milk/formula on the APP concentrations in saliva.~      Objective(s) and Hypothesis(es):~      The investigators objectives are to identify and serially determine the concentrations of~     key APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and~     specific mass spectroscopy methods. The investigators study is designed to test the~     hypotheses that (a) all saliva APPs increase over time, (b) APP concentrations are higher in~     colostrum as compared to human milk, and (c) APPs are increased in saliva of infants that~     receive colostrum orally compared to those that do not.~      Potential Impact:~      If increased saliva APP levels are associated with oral colostrum priming, this discovery~     would advance understanding of the immune properties of human milk and identify oral APPs as~     important immune elements and potential therapeutic targets in this vulnerable population.~     This knowledge has the potential to alter feeding practices and provide a safe, low cost~     means to improve immune function and significantly improve outcomes for preterm infants.~   "
97850|NCT01776255|"~     Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood~     intervention which addresses the growing problem of childhood obesity in American Indian~     communities. The study works with six rural and urban American Indian communities across the~     US to test the ability of the intervention to increase adoption of healthy lifestyles and to~     reduce the prevalence of obesity among preschool aged American Indian children and their~     primary caregivers - creating healthier children, healthier families and healthier~     communities. Our primary hypothesis is that children and their primary caregivers who~     receive the HCSF-2 intervention will have better obesity related outcomes than those who do~     not receive HCSF-2.~   "
97851|NCT01776242|"~     The overall objective of BOLD is to establish a large, community-based registry (at least~     5000 subjects) of patients aged 65 years and older presenting with new episodes of~     healthcare visits for back pain. BOLD's primary aim is to create an infrastructure that~     allows for the conduct of prospective, controlled studies comparing the effectiveness of~     diagnostic and treatment strategies for back pain in older adults.~   "
97852|NCT01776229|"~     Untreated trauma-related nightmares and sleep-related disorders are associated with chronic~     health problems, burdening both the suffering individual and the health-care system. The~     study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed~     children. It is the first randomized clinical trial with children, adapting an efficacious~     adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a~     mechanism in development and maintenance of secondary post-trauma psychopathology, medical~     problems and family dysfunction. Therefore, this treatment may prevent long-term secondary~     health and behavioral problems. It provides a viable healthcare option to Oklahomans,~     lessening long-term financial medical and behavioral health expenses. Scientific models~     currently view PTSD treatment as primary, often leaving nightmares untreated. That approach~     does not address the pernicious impact of trauma-nightmares in individuals with~     sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation~     of this therapy can advance the field's understanding of the development of trauma sequelae.~   "
97853|NCT01776216|"~     Hypertension and endothelial dysfunction are being increasingly recognized as key~     etiological factors in the development of atherosclerosis and subsequent cardiovascular~     disease (CVD). A substantial body of evidence indicates that treating patients with elevated~     blood pressure (BP) leads to marked reduction in the risk of stroke, myocardial infarction,~     heart failure, and renal failure. There is also accumulating evidence associating~     endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when~     required, to elevated BP and an increased risk of CVD.~      While there are more and more studies on how diet affects BP in healthy subjects, the impact~     of dairy consumption per se on both endothelial function and ambulatory BP has not been well~     characterized in patients with established essential hypertension. Therefore, the general~     objective of the study is to investigate in a single-blind randomized controlled study the~     impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild~     to moderate essential hypertension.~   "
97854|NCT01776203|"~     In this study, the investigators would like to see if giving medroxyprogesterone acetate for~     3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding,~     decrease the amount of nausea, bloating and cramping and increase patient satisfaction~   "
97855|NCT01776190|"~     The investigators are conducting an open-label clinical trial determining the effects of~     UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE)~     subjects indicates that this treatment is likely to be effective in treating cutaneous lupus~     with few side effects. The fact that most CLE patients are seen at dermatology clinics also~     increases the usefulness of this study because there is a large probability that~     phototherapy treatment will be accessible for many of the patients that stand to benefit~     from it.~   "
97869|NCT01776008|"~     This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or~     without goserelin acetate works in treating patients with stage II-III breast cancer.~     MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by~     the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more~     tumor cells.~   "
97935|NCT01775150|"~     We plan to integrate WHO educational material using mobile phone text messaging, target on~     pregnant women in remote rural areas in China. We hypothsized that text messaging can have~     major impact on reducing maternal and infant deaths in rural China because text messaging is~     accessible, acceptable, and affordable.~   "
98041|NCT01773811|"~     The current study proposes to directly measure how processing after participating in written~     disclosure about a traumatic life event affects physical and psychological outcomes.~   "
97857|NCT01776164|"~     Friedreich's ataxia is characterized by progressive alterations in the function of the~     cerebellum accompanied by an atrophy of the spinal cord. Although the genetic defect~     responsible for the disease has been identified more than 15 years ago, objective markers of~     the pathologic process (i.e., biomarkers) that would allow measuring the effects of~     potential therapies are still lacking. Moreover, it is still unclear how the malfunction of~     the cerebellum affects the rest of the brain, and understanding the connectivity and~     neurochemistry of the central nervous system might yield new insights in the understanding~     of the disease, in addition to providing potential markers.~      To address these needs, the investigators aim at utilizing the capabilities of Magnetic~     Resonance Imaging (MRI) and Spectroscopy (MRS). Using techniques called Diffusion Imaging,~     resting-state functional MRI, and Proton Spectroscopy (1H MRS), the investigators propose to~     determine the differences in the connectivity and neurochemistry of the spinal cord and the~     brain between patients affected by Friedreich's ataxia and healthy controls. The~     investigators plan on imaging both patients and control subjects using a 3T magnet, a system~     that although not yet available in all medical facilities, is becoming standard in most~     hospitals and clinics. The first aim is to scan patients already scanned last year (12-month~     follow-up). The second aim is to scan patients at an early stage of the disease.~   "
97858|NCT01776151|"~     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500~     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at~     reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350~     cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk~     of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart~     disease. In this study, the stiffness of arteries will be measured at study entry, months 4,~     8, 12, and annually thereafter, using a tonometer on the participant's forearm.~   "
97859|NCT01776138|"~     The purpose of this study is to create a registry of older patients undergoing surgical~     and/or medical treatment for bladder cancer. The registry will record side-effect and~     outcomes related to the treatment using different surveys and biological measures.~   "
97860|NCT01776125|"~     Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various~     types of nerves and, in addition, can affect the development of bones and skin. It occurs in~     1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and~     Schwannomatosis. NF1 is the focus of this study.~      NF1 is an extremely variable disorder which ranges from extremely mild cases in which the~     only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal~     neurofibromas, to more severe cases like disfigurement, scoliosis and learning disabilities.~     Scoliosis (abnormal curvature of the spine) is perhaps the most common bone deformity in NF1~     which usually appears in early childhood. There are two types: dystrophic and non-dystrophic~     scoliosis. Dystrophic scoliosis is usually associated with other bone deformities which are~     seen on x-ray and carries a poorer prognosis than non dystrophic scoliosis. There is~     evidence that genes other than the NF1 gene are responsible for the variable severity of~     cases. Recent studies have identified genetic markers for another condition called~     adolescent idiopathic scoliosis (scoliosis which presents in adolescent age group with no~     known cause). We believe that the same genetic markers may also be present in NF1 patients~     with scoliosis.~      Our objective is primarily to determine if the same genetic markers discovered in adolescent~     idiopathic scoliosis are also present in NF1 patients with scoliosis.~   "
97861|NCT01776112|"~     To explore: (a) if physical exercise (sports) combined with cognitive training leads to~     (superior) improvement of cognition in schizophrenia compared to sports or cognitive~     training alone (b) if a sports program alone or in combination with cognitive training has~     influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a~     placebo condition.~   "
97862|NCT01776099|"~     In animal models and retrospective studies, certain food components such as sugars and fiber~     have been detected as potential agents to influence development and progress of type 2~     diabetes.~      The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs.~     soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters~     in patients with long-term type 2 diabetes and intensive insulin treatment.~   "
97863|NCT01776086|"~     The purpose of this studying is to develop and characterize neuropsychological testing~     software for evaluating the prefrontal and temporal function of patients. As no software has~     been used for this purpose, this study will gather pilot data on the baseline performance of~     patients in a hospital setting that lack any neurological impairment. After creating this~     baseline, later experiments can be proposed to compare the performance in normal subjects~     with those who have neurologic injury or disease.~   "
97864|NCT01776073|"~     The purpose of this study is to measure the effect of introducing a patient navigator to~     guide high and moderate risk patients through the pre-waitlisting phases of the kidney~     transplant process. Patients identified as being at high and moderate risk of delay to~     waitlisting will be linked with a patient navigator, who will facilitate their completion of~     pre-waitlisting requirements. We believe that patients who are randomized to a patient~     navigator will be more likely to complete the pre-waitlisting process and will complete the~     process more quickly than high and moderate risk patients who do not receive additional~     assistance from a patient navigator.~   "
97865|NCT01776060|"~     The goal of this study is to enroll 100 participants with Primary Progressive Multiple~     Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and~     the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a~     biannual collection of a follow up questionnaire and blood/urine collection for a period of~     5 years.~   "
97866|NCT01776047|"~     Study Design : randomized, open label, single-dose, 2-way cross-over design~      Phase : Phase I~   "
97867|NCT01776034|"~     The objective of this study is to conduct a randomized controlled pilot study to examine the~     efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program~     in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program~     will help overweight and obese stroke survivors engaging in healthy behaviors, thereby~     improving health and function.~   "
97868|NCT01776021|"~     The purpose of this study is to compare the effects of a cranberry juice beverage on rates~     of Urinary tract infection (UTI) recurrence in women with a history of UTI.~   "
97871|NCT01775982|"~     To validate the French version of the CAM, a multicenter diagnostic study will be conducted.~     The principle of this study is identical to the study of Inouye which initially validated~     the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version)~     compared to the gold standard represented by the confused state of psychiatric diagnosis~     using the DSM.~      A representative sample of geriatric patients for whom a delirium is suspected, will be~     recruited in the various participating centers, patients will undergo two consecutive~     visits:~        -  A visit by a geriatrician, during which the confused state of the patient will be~          evaluated using the French version of the CAM.~        -  A visit by a psychiatrist during which the diagnosis of confusional state will be~          evaluated using the gold standard criteria of the DSM IV.~      These two evaluations will be conducted on the same day and blinded from each other.~      The order of these two procedures will be balanced within each center. This process will~     allow the calculation of diagnostic parameters of the CAM French version (validation~     competitive): sensitivity, specificity, positive and negative predictive values .~   "
97872|NCT01775969|"~     Outpatient antibiotics are frequently prescribed from the emergency department, and limited~     health literacy may impact compliance with recommended treatments. The investigators are~     looking to determine if patient preference for multimodality discharge instructions for~     outpatient antibiotic therapy varies by health literacy level, and if modality effected~     patient-reported antibiotic compliance and 72-hour antibiotic pick-up.~   "
97873|NCT01775956|"~     Septic shock remains the dominant cause of death in ICU's of the developed world with~     approximately 400,000 cases annually in the US and another 20,000 annually in Canada. While~     many retrospective and prospective reviews of septic shock patients have been undertaken~     worldwide, many key questions remain unanswered. These questions include the true incidence,~     associated morbidity and mortality of septic shock in North America, key factors associated~     with successful management and markers suggesting a high probability of a complicated~     clinical course. Part of the reason for the persistence of these questions, is the fact that~     previous and ongoing reviews of septic shock and severe sepsis have been either limited in~     number (typically <150) or biased by the need to be eligible for specific clinical trials~     (typically, non-eligible patients have not been followed and had data collected.~      We propose to examine specific questions within a temporally comprehensive cohort of septic~     shock patients by review of individual charts using a defined data-extraction template.~   "
97874|NCT01775943|"~     Lung cancer is the leading cause of cancer-related death worldwide and is well known to~     remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80%~     of all the cases of lung cancer.~      Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations~     within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset~     of NSCLC patients.~      Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for~     L858R in exon 21, which account for 85% of all clinically important mutations related to~     EGFR TKI sensitivity.~      Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered.~     G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame~     insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.~      However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR~     mutations are also observed. These rare mutations have not been fully described and data on~     their correlation with response to EGFR-TKIs are still unclear.~      Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients,~     which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon~     20, have some possibility of EGFR TKI sensitivity.~      Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR~     TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during~     the short period.~   "
97875|NCT01775930|"~     The goal of this clinical research study is learn if carfilzomib can help control kidney~     cancer. The safety of this drug will also be studied.~      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~   "
97876|NCT01775917|"~     During the recent decades the need for surgical evacuation of the uterus in early~     miscarriages and incomplete miscarriages has been questioned.~      It has been shown that an observational approach can be, in many cases, as good as an~     invasive one without increasing the incidence of uterine infections.~      it has been shown that misoprostol - prostaglandin E1 given for missed abortions is~     successful in emptying the uterus in 85% of cases without any need for surgical~     intervention. and during recent years many women prefer this approach than the surgical one~     .~      Many have tried using sonographic signs such as endometrial thickness, the presence of a~     gestational sac, and color doppler to differ between blood clots and a gestational residua~     in uterus, and to decide according to these signs wether there is a need for surgical~     evacuation or an expectant management could be used. but none of these methods have been~     proven to be completely efficient as predictors.~      In this study the investigators will examine whether the doppler indices in the uterine~     arteries can help to predict which gestational residua needs surgical evacuation of the~     uterus and which could be managed expectantly.~      The study hypothesis is that the resistance in uterine artery doppler will be lower in cases~     with intrauterine residua as opposed to high resistance in cases without residua.~   "
97877|NCT01775904|"~     The purpose of this study is to evaluate two different formulations of LY2886721. In~     addition, this study will determine how much of study drug (LY2886721) gets into the blood~     steam and how long the body takes to get rid of it after taking each formulation with or~     without a meal. Information about any side effects that may occur will also be collected.~     Each participant may be involved in the study for approximately 7 weeks.~      This study requires 4 periods. In each period, participants will receive LY2886721 as a~     tablet or capsule, with or without food and water. There is a 7 day washout between each~     period.~   "
97878|NCT01775891|"~     Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF~     could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with~     other class IC antiarrhythmic drugs.~   "
97936|NCT01775137|"~     The purpose of this extension study is to collect additional 48 weeks of safety data from~     patients taking TIP who have completed the core study CTBM100C2401. The purpose of~     collecting second year safety data through this study is to obtain long-term (2 years)~     safety data of TIP.~   "
97879|NCT01775878|"~     The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and~     will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa~     Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be~     randomly assigned to one of two treatment arms. The telemedicine group or the group~     receiving usual care (the control group).~      This study hopes to show the usefulness of this telemonitoring technology and more~     specifically, to assess whether this device improves markers of control of diabetes,~     glycemic control, and cardiovascular risk factors~   "
97880|NCT01775865|"~     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United~     States with older age being a primary risk factor. The number of adults greater than age 65~     years will almost double to 70 million by 2030, therefore identifying therapeutic strategies~     for treating or preventing age-related disorders in humans is of major biomedical~     importance. Cardiovascular aging, defined as a reduction in vascular and cardiac functions~     with normal aging, occurs even in the absence of CVD risk factors and overt CVD. A key~     feature of cardiovascular aging is stiffening of the large elastic central arteries such as~     the aorta (the large blood vessel that leaves the heart and supplies blood to the body).~     This is important because aortic stiffness directly contributes to clinical problems such as~     increased blood pressure, reduced blood flow to the heart muscle, and thickening of the~     heart muscle. Therefore, these clinical consequences are hypothesized to mediate a~     substantial proportion of the increase in CVD risk in older adults. However, effective drug~     treatments for aortic stiffness are not currently available and the biological reasons~     (mechanisms) involved in causing aortic stiffening remain undefined. In addition, the~     inability of smaller blood vessels to relax, impairment of the heart to relax during the~     filling phase of the heart cycle (i.e., diastole), and increased blood pressure variability~     (fluctuations in blood pressure through the day), have all been linked to aortic stiffness.~     Furthermore, chronic low-grade inflammation with advancing age has been proposed to be a~     common mechanistic link (i.e., biological reason) between these reductions in cardiovascular~     function in older adults. Therefore, the investigators propose that inflammation could be a~     novel therapeutic target to treat cardiovascular aging in older adults. Our central~     hypothesis is that inflammation mediates the age-related deterioration in cardiovascular~     functions observed with advancing age through the development of oxidative stress (i.e.,~     imbalance between cellular production of damaging oxygen free radicals vs. protective~     antioxidants). Our hypothesis predicts that chronic inhibition of inflammation with~     Salsalate, an FDA-approved anti-inflammatory drug similar to aspirin that is typically used~     to treat rheumatoid arthritis pain and known to inhibit the 'master' regulator of~     inflammation in the cell (i.e., nuclear factor kappa B), will improve cardiovascular~     function in older adults. In addition, the investigators hypothesize that the mechanism for~     the improvement in cardiovascular function during inhibition of inflammation will be by~     suppressing oxidative stress. To test our hypothesis, the investigators will randomize older~     healthy adults (age 50-79 years) to 3 g/day of salsalate or placebo (i.e., pill with~     inactive substance) pills for 4 weeks and have cardiovascular function measured at baseline~     and again after 4 weeks.~   "
97881|NCT01775852|"~     The purpose of this research study is to examine whether a one-day group workshop,~     integrating principles from Acceptance and Commitment Therapy with Migraine Education, will~     result in improvements in depressive symptoms and functioning impairment in patients with~     comorbid migraine and depression.~   "
97882|NCT01775839|"~     Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of~     co-administered drugs~   "
97883|NCT01775826|"~     The majority of the US population spends most of the day sitting and the we have new~     scientific evidence that this can contribute to poor health regardless of how much physical~     activity a person does. However, we do not measure sitting time very accurately and when we~     ask people to tell us how much they do, their answers are unreliable. Our study will use~     small sensors to objectively measure when people sit or do physical activity, and we will~     use sophisticated computational techniques to summarize these movement patterns.~   "
97884|NCT01775813|"~     The Health Influences of Puberty (HIP) Study is designed to explore the relationships~     between puberty and the onset of type 2 diabetes in adolescents. The results of this study~     will help us better understand how to prevent type 2 diabetes in these youth. Children go~     through many changes during puberty, including important hormonal and behavioral~     alterations. Among these changes, it has long been known that, during puberty, insulin does~     not work as well as it does before and after puberty. This is called physiologic insulin~     resistance. In healthy children, this does not cause diabetes or affect blood sugar in any~     way because the body is able to compensate by making more insulin. Indeed, this is thought~     to be an important part of the adolescent growth spurt. However, in some children with~     increased risk for developing type 2 diabetes due to obesity and genetics, the worsening~     insulin resistance of puberty cannot be compensated for and these youth get diabetes early.~     The investigators believe this is because type 2 diabetes is rarely, if ever, seen before~     puberty begins, and the peak of diabetes onset in adolescents occurs at the time of the~     worst insulin resistance. This specific research project has two goals: 1. To examine~     effects of obesity on how well the body's insulin works during puberty, and 2. To see if~     treatment of obese children during this critical period of puberty with a medication that~     improves insulin resistance (metformin) will help prevent early onset type 2 diabetes.~   "
97885|NCT01775800|"~     Many patients on hemodialysis experience high rates of symptom burden, such as pain,~     depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by~     modifying the usual guidelines used to manage patients on hemodialysis. For example, rather~     than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have~     treatment goals of less than 6.5, in order to reduce the number of pills they need to take~     and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone~     goals will also be modified, to see if these modifications help hemodialysis patients feel~     better.~   "
97886|NCT01775787|"~     This study will examine whether nicotine levels increase with electronic cigarettes. It will~     also examine whether electronic cigarettes alter lung function tests. The study will obtain~     preliminary data on the medical effects of electronic cigarettes, with two different~     nicotine flavors, tabacco and tabacco with menthol, which are available for over the counter~     purchase.~      The elctronic cigarettes and juice used in this study is available for purchase through the~     internet. An investigational new drug application (IND) is not needed for this study.~   "
97887|NCT01775774|"~     This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic~     Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute~     Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of~     hMSCs in patients with ARDS.~   "
97888|NCT01775761|"~     The purpose of this study is to investigate the effects of tafamidis on the intervals of the~     electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.~   "
97910|NCT01775475|"~     This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral~     chemotherapy works in treating patients with previously untreated stage III-IV human~     immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone,~     lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug (combination chemotherapy) may kill more cancer cells~   "
97889|NCT01775748|"~     The study will compare Concord grape juice to a beverage that contains no grape flavonoids,~     but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese~     participants over age 50 will be enrolled. Each participant will drink each beverage for 4~     weeks with a 2-week rest period between two beverage consumption periods. The order of~     beverages (grape juice first or placebo juice first) will be randomized. The investigators~     will use ultrasound to measure brachial artery flow-mediated dilation, a measure of~     endothelial vasodilator function. The investigators will also collect blood samples to~     further assess the cardiovascular effects of grape juice.~      The aim of the study is to determine whether Concord grape juice improves endothelial~     function in patients at risk who do not have cardiovascular disease and may provide~     information that would guide dietary recommendations. The results may also be used by the~     sponsor to substantiate claims and labeling of their product.~   "
97890|NCT01775735|"~     The primary objective of this study is to evaluate the safety and efficacy of occipital~     nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in~     the management of intractable chronic migraine, when used in conjunction with anti-migraine~     medications.~   "
97891|NCT01775722|"~     Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin.~     However, even though the pulsed dye laser is considered as the treatment of choice for Port~     wine stain Birthmark the degree of fading can remain variable and unpredictable after laser~     treatment.~   "
97892|NCT01775709|"~     Otitis media is the most common illness in children and 5% to 10% of their symptom cause by~     fluids in their middle ear . The OME can cause hearing loss included poor development of~     speech and poor communication.~      The surgical procedure is considered simple and relatively safe, but several complications~     may occur after Pressure Equalizing tube insertion. The most prevalent complications are~     otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of~     children with tube and is mainly due bacterial contamination of the middle ear either from~     external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of~     bacteria into the middle ear from the ear canal through the PE tubes, and this assumption is~     reinforced by the statistically significant association between the rate of otorrhea and the~     non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs~     to 56% in those who did not).~   "
97893|NCT01775696|"~     The main objective of this study is to investigate the central and peripheral inflammatory,~     as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early~     stages of AD by combining molecular imaging techniques with blood biomarker analyses. The~     early and preclinical stages of AD will be studied in the relatives of patients with PSEN1,~     PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will~     evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD~     progression. Inclusion of sporadic and familial forms of AD will aid in studying the~     chronology of pathological events. Clinical follow-ups will be conducted annually for two~     years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear~     in the early stages of the disease and to constitute new prognostic factors. I2ARs could~     also become therapeutic markers for the assessment of novel anti-amyloid treatments and may~     offer new insights to the development of Aβ-specific immunotherapy strategies.~   "
97894|NCT01775683|"~     Homeless men and women suffer more illness and sooner death compared to housed people. Among~     the homeless, there is a group that suffers more illness than others. This group is usually~     homeless for several months, makes up a smaller proportion of homeless people and uses more~     resources from emergency shelters than other homeless people. Some have asked if a~     difference in thinking skills explains how people who are homeless for a long time need more~     help in getting and keeping housing compared to other homeless persons.~      In this study, thinking skills that help a person plan and make decisions will be screened~     among those who have been homeless for a long time and those who were homeless for a short~     time. If there is a difference, then screening may change how future homeless people get the~     help they need.~   "
97895|NCT01775670|"~     The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints~     provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.~   "
97896|NCT01775657|"~     This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on~     the duration of pleural drainage after lung resection in patients with and without a~     pulmonary air leak on postoperative day 1.~      Patients undergoing pulmonary resection who fit the inclusion criteria will be identified~     pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to~     receive either the analogue system or the digital system. Both systems are approved for use~     in hospitals by Health Canada. There will be 88 patients in each air leak group.~      Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an~     improvement in primary outcomes.~   "
97897|NCT01775644|"~     This observastonal multicenter study will evaluate the differences of progression-free~     survival in defined subgroups of patients with metastatic colorectal cancer receiving~     Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data~     will be collected for up to 5 years.~   "
97898|NCT01775631|"~     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose~     of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma~   "
97911|NCT01775462|"~     This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male~     newborns in the first two weeks of life. All subjects will meet entry criteria including~     documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline~     evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study~     subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two~     cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy,~     and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most~     relevant preclinical model. Given the challenge of identifying families where the subject is~     yet to be born, it is expected that cohort size and time for recruitment will be variable.~   "
97937|NCT01775124|"~     The study will evaluate the efficacy and safety of two different dosing regimens of~     ranibizumab (either monthly injections or injections as-needed based on the stability of a~     patient's vision) in Chinese patients with wet AMD . This study is to provide long-term~     safety data in the treatment of Chinese patients with wet AMD.~   "
97899|NCT01775618|"~     Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to~     form blood clots is missing or not present in sufficient levels. Hemophilia A causes the~     clotting process to be slowed and the person experiences bleeds causing serious problems~     that could lead to disability. The current standard treatment for severe hemophilia A is~     infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from~     occuring. Due to the short half-life of FVIII, prophylaxis may require treatment as often as~     every other day.~      In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being~     evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects~     will receive open label treatment with long-acting rFVIII for approximately 6 months (or~     longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and~     dose intervals may be adapted to the subject's clinical need. A second group of patients~     will receive open label treatment with the same drug for 12 weeks on a regular schedule of~     2x/week. Patients will attend the treatment center for routine blood samples and will be~     required to keep an electronic diary.~      Subjects will be offered participation in an optional extension study to collect~     observations for at least an additional 50 exposure days.~   "
97900|NCT01775605|"~     Local infiltration with lidocaine prior to epidural placement for cesarean section, although~     brief, can be painful. This pain can lead to increased anxiety and distress, adversely~     affecting patient's overall experience. This study proposes to examine the application of~     Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.~      The primary objective of this study is to determine the effect of the Synera on maternal~     experience during epidural placement. The efficacy of Synera pain patch in reducing subject~     pain during skin infiltration with lidocaine prior to epidural placement in subjects~     presenting for scheduled cesarean section will be assessed.~   "
97901|NCT01775592|"~     Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the~     successful treatment of malaria, has been confirmed in Cambodia. There are few reports from~     neighbouring countries about delayed parasite rates. The investigators therefore aim to~     assess parasite clearance in malaria patients in central Vietnam when treated according to~     national standard guidelines.~   "
97902|NCT01775579|"~     We investigate the potential pharmacokinetic drug-drug interaction between metformin~     extended release and rosuvastatin in healthy male volunteers who receive metformin extended~     release alone, rosuvastatin alone, and both together in a 3 period repeatedly.~   "
97903|NCT01775566|"~     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the~     Eperisone HCl SR and Myonal in healthy Korean male adults.~   "
97904|NCT01775553|"~     The purpose of this study is to determine the safety and activity of the investigational~     drug known as carfilzomib in the treatment of multiple myeloma (MM) when it is given at~     doses above the usual dose after the standard dosing has become ineffective. The other~     purpose of this study is to understand what causes the multiple myeloma to become resistant~     to carfilzomib and whether this can be overcome in the laboratory.~   "
97905|NCT01775540|"~     This study was to evaluate the healing action on the eye surface of the artificial tear~     Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye~     disease leads to inflammation of the eye surface and treating dry eyes with artificial tears~     may lead to reduction in this inflammation and improvement of symptoms and signs.~   "
97906|NCT01775527|"~     IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it~     represents an important cause of end-stage kidney failure. This disease was described as a~     distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis~     remain still obscure. Clinical observations and immunisation studies indicate that IgAN~     represents a dysregulation of the immune system, rather than an intrinsic renal abnormality.~     Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the~     pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in~     systemic sites. The unusual characteristics featured by the IgA produced by these cells~     (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation~     characteristic of IgAN.~      Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant~     localization.~   "
97907|NCT01775514|"~     This non-interventional study will assess the occurrence rate of non-small cell lung cancer,~     colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the~     diagnostic methods and treatments used. Data will be collected over 36 months.~   "
97908|NCT01775501|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational combination of drugs to learn whether the drug~     combination works in treating a specific cancer. Investigational means that the modified~     FOLFOX and sorafenib combination is still being studied and that research doctors are trying~     find out more about it-such as the safest dose to use, the side effects it may cause, and if~     the combination is effective for treating different types of cancer. It also means that the~     FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in~     this study for liver cancer.~      FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and~     oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified~     slightly in this study. The FOLFOX combination is approved by the FDA and is a standard~     treatment of colorectal cancer. However, it is not approved for the treatment of liver~     cancer.~      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of~     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by~     slowing down and/or stopping the development of new cancer cells and new blood vessels. By~     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed~     that sorafenib prevents or slows down the growth of tumors.~      In this research study, sorafenib, the standard treatment, is being combined with modified~     FOLFOX, which has shown some antitumor activity in liver cancer.~   "
97909|NCT01775488|"~     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy~     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx~     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.~   "
97960|NCT01774825|"~     After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching~     placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms~   "
97912|NCT01775449|"~     Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal~     cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by~     acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy~     appearing with the repetition of chemotherapy cycles.~      To this date there is no effective therapy able to prevent and/or to treat these adverse~     drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to~     stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute~     oxaliplatin-induced hypersensitivity in animals.~      So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may~     prevent acute oxaliplatin-induced hypersensitivity in patients.~   "
97913|NCT01775436|"~     Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting~     co-morbidities to decrease suffering and increase quality of life (QOL). Left without~     advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may~     result in families being charged with neglect or court battles over treatment choices, unmet~     care or delivery of unnecessary or unwanted care, and non-relative caregivers being~     dismissed (e.g. gay partners). We hope to increase families' understandings of their family~     member's wishes for end-of-life care to decrease conflict through the FAmily-CEntered~     Advance (FACE) Care Planning intervention. We will also study communication, quality of~     life, and spiritual struggle. Families will be randomized into either the Control (N=96~     families) or the FACE Intervention (n=192 dyads). FACE families will meet with a~     trained/certified researcher for two 60-minute sessions scheduled one week apart: Session 1:~     The Respecting Choices Interview®; and Session 2: Completion of The Five Wishes©. Control~     families will also meet with a researcher for two 60-minute sessions scheduled one week~     apart: Session 1: Developmental History; and Session 2: Nutrition and Exercise.~     Questionnaires will be administered five times, Baseline and at 3, 6, 12 and 18 month~     post-intervention, for an average of 2 years.~      AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA~     and their surrogates over time, and the effect of the pattern of congruence development~     trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations,~     dialysis, ER visits).~      Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the~     pattern of congruence development.~      Hypothesis B: Different patterns of congruence development may have different effects on~     health care utilization.~      Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over~     time.~      AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE~     participants will increase or better maintain psychosocial QOL compared to Controls.~      AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify~     factors associated with disparities.~      Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate~     comparable to non Blacks, and at significantly greater rates compared to Controls.~   "
97914|NCT01775423|"~     This is an open label, single arm, dose escalation study of BBI608 in patients with advanced~     malignancies.~   "
97915|NCT01775410|"~     This is a prospective, multi-center, non-randomized single arm feasibility trial of the~     Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed~     with peripheral vascular disease of the lower extremities.The primary disease must be~     located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate~     to severe symptoms and warrant vascular intervention.~   "
97916|NCT01775397|"~     The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical~     cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive~     therapy.~   "
97917|NCT01775384|"~     Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the~     Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green~     tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced~     physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both~     traditional and metabolomics-based outcome measures.~   "
97918|NCT01775371|"~     Background: Inadequate pain management is common in the Emergency Department (ED). Optimal~     treatment of pain necessitates titration to effective dose due to the large inter-individual~     variability in opioid requirement. However nurse administered titration is difficult to~     provide in this setting due to high patient to nurse and physician ratios and multiple~     urgent competing patient demands. Patient controlled analgesia (PCA) lets ED patients~     actively participate in pain management by allowing self-titration to their desired level of~     pain relief. A tightly controlled randomized clinical trial (RCT) funded by NINR recently~     completed by the investigators group provides promising preliminary support for the efficacy~     and safety of PCA for patients with abdominal pain at a single ED with a dedicated research~     nurse and standard loading dose given to all patients. Objective: The overall objective is~     to provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness~     and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver~     the intervention to a broad group of ED patients with acute pain at multiple clinical~     centers. The primary hypothesis is that there will be a greater decline in pain over time~     and similar safety in patients randomized to receive PCA compared to patients receiving~     standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and~     provider acceptance, resource utilization and cost associated with PCA. Innovation: PCA~     represents a novel shift from the current provider-driven model of ED pain management to one~     in which the patient is an active participant. Few prior studies have evaluated ED PCA and~     no systematic evaluation of time and resources exists. Methodology: An RCT will be performed~     at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will~     be randomized to receive usual opioid analgesia determined by the provider or PCA (loading~     dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain~     intensity will be measured by a numerical rating scale recorded every half hour up to 2~     hours after initial opioid administration. Primary endpoints are rate of change in pain~     intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by~     the results of the preliminary study and incidence of adverse events. PCA will also be~     compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by~     patient satisfaction with pain management; RN assessment of time efficiency/ease of use and~     satisfaction with pain management; and physician satisfaction with pain management. Resource~     utilization and cost associated with implementation and use of PCA in the ED setting will be~     assessed by total RN time spent on pain management per patient; pharmacy preparation time~     per patient; material cost per patient and RN and MD training time necessary for PCA~     implementation. Significance: If PCA is demonstrated to be effective, safe, and associated~     with patient and provider acceptance and acceptable resource utilization, it has the~     potential to significantly improve ED pain management.~   "
97919|NCT01775358|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.~   "
97920|NCT01775345|"~     To determine that rehabilitation treatment for a partial meniscectomy is more efficient in~     the functional recovery of the knee. Set in the fewest possible sessions, what treatment has~     benefits that last beyond the physical and what is the best cost-effectiveness.~      It is expected that the combination of isotonic and isokinetic exercises in~     post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the~     current isotonic protocol.~   "
97921|NCT01775332|"~     The purpose of this research study is to determine the utility of educational materials~     designed to inform patients of their pituitary condition, in an effort to assist the~     patients, families, and staff deal with pituitary tumours and related conditions in the best~     way possible. We have developed a website, informational videos, and a brochure for~     pituitary tumour patients and their families. The primary outcome measures will be 1) the~     level of knowledge that patients have of their condition before and after reviewing the~     materials provided; and 2) ease of use and user satisfaction of the materials. We~     hypothesize that our informative multimedia educational package will not only improve the~     health literacy and self-efficacy of patients and their families, but will also improve~     quality of care.~   "
98043|NCT01773785|"~     The primary purpose of this study is to determine the effectiveness of SPI-1620 in~     combination with docetaxel in patients with advanced biliary cancer.~   "
97922|NCT01775319|"~     Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable~     isotope absorption studies in women of childbearing age consuming test meals prepared from~     either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two~     different extraction rates.~      Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat:~     stable isotope absorption studies in women of childbearing age, or men, consuming test meals~     prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or~     post-harvest fortified wheat extrinsically labeled immediately before consumption.~   "
97923|NCT01775306|"~     The aim of this study is to find out if data can be provided by external sensor technology~     which is suitable for controlling the therapy of patients with cardiac recompensation.~   "
97924|NCT01775293|"~     The aim of this study is to evaluate the efficacy and safety of the investigational device,~     RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.~      Study hypothesis~        -  level of significance: alpha=0.05( two-side)~        -  power of test: (power= 1-beta),power=0.08~        -  H0: P equals P0~        -  H1: P unequals P0~        -  The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the~          pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0=~          0.237)~   "
97925|NCT01775280|"~     The study enrolls patients with non-resectable or borderline resectable hepatocellular~     carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis.~     Patients are not a candidates for liver transplantation and have only limited extrahepatic~     disease. All patients are treated with radioembolization. Primary endpoint is the percentage~     of patients that can be downstaged to resectability.~      Secondary endpoints are radiologic response to radioembolization,tissue response to~     radiomembolization and systemic immune response and intra-tumoral T-cell response to~     radioembolization.~        -  Trial with radiotherapy~   "
97926|NCT01775267|"~     This randomized phase II trial compares how well associating liver partition with portal~     vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in~     treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for~     removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would~     traditionally be considered inoperable.~        -  Trial with surgical intervention~   "
97927|NCT01775254|"~     The overall purpose of this study is to describe the trajectory of early survivorship in~     individuals with colon cancer who undergo both surgical and medical management of colon~     cancer. The primary question is whether or not there is an interaction between type of~     surgery and changes in quality of life, sexual function, peripheral neuropathy, and demands~     of illness following curative resection and adjuvant chemotherapy.~   "
97928|NCT01775241|"~     It is the objective of this study to collect scientific data of sleep apnoea syndrome~     patients´ cardiac and respiratory function by additional sensors.~   "
97929|NCT01775228|"~     Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving~     physical recuperation and psychological adjustment. The high prevalence of postoperative~     depression in this population may threaten optimal recovery. Peer support over the recovery~     period has promise to mitigate this threat. The purpose of this study was to examine the~     effect of a professionally-guided telephone peer support intervention on recovery outcomes~     including depression, social support and health care resource utilization.~      In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an~     intervention (n=61) or usual care (n=124) group. Participants in the intervention group~     received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At~     hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck~     Depression Scale-II, social support was measured using the Shortened Social Support Scale~     and health care resource utilization was measured using items in the Postoperative Self~     Report of Recovery Questionnaire. Participants in the intervention group were also asked~     questions about their perceptions regarding peer support using the Peer Support Evaluation~     Inventory.~   "
97930|NCT01775215|"~     In patients with aortic stenosis the valve through which blood is pumped out of the main~     heart chamber is narrowed. This results in heart muscle working harder to open the valve so~     blood can circulate around the body. The muscle adapts to the increased pressure load to~     maintain efficiency. This can cause long-term muscle damage. To predict when this~     deterioration will require a valve replacement is difficult and untimely operation exposes~     patients to unnecessary risk.~      We aim to compare all validated techniques looking at different aspects of heart muscle~     strain in these patients. These will be a blood sample measuring a specific hormone (BNP)~     and enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying~     scarring and an exercise echocardiogram that measures heart muscle response and pressure~     changes across the valve. Tests will be performed at recruitment and either after one year~     or after valve replacement, which ever comes first.~      In comparing these different imaging techniques we aim to identify patients who will benefit~     from an early operation, those whose muscle is likely to recover back to normal and which~     patients it is safe to wait longer for the surgery, avoiding unnecessary risk.~      The results of the study will benefit patients as it will help doctors more accurately~     assess the timing of valve surgery and improve their prediction of long term heart muscle~     recovery. It may also increase convenience in clinical management by reducing unnecessary~     tests and hospital trips. This would translate into cost savings for the NHS.~   "
97931|NCT01775202|"~     This descriptive study aims to evalaute in a retrospective way the incidence of cogntive~     changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is~     based on chart reviews.~   "
97932|NCT01775189|"~     The main purpose of this study is to determine if oxycodone and naltrexone combination~     capsules (ALO-02) have the potential to be abused when they are crushed and snorted.~   "
97933|NCT01775176|"~     The purpose of the study is to test in 52 overweight and obese women with polycystic ovary~     syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary~     restriction or metformin in comparison to a control group receiving no intervention on the~     functions of the skeletal muscle and adipose tissue.~   "
97934|NCT01775163|"~     The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and~     spontaneous physical activity in a subset of 60 obese individuals enrolled in the main~     study. We aim to determine if changes in energy metabolism might explain why people don't~     lose the expected amount of weight in an exercise program.~   "
97938|NCT01775111|"~     The aim of this randomized, observer-blind, controlled intervention study with parallel~     groups is to study the effect of strength training (2x/week for 6 months) with and without~     additional dietary supplementation (protein-enriched) on muscle strength, function and mass,~     oxidative stress parameters and the immune system in elderly institutionalized persons.~      The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener~     Pensionistenwohnheime). After a pre-participation screening participants will be distributed~     randomly but stratified by sex and age to one of the 3 intervention groups (cognitive~     training, strength training, strength training + supplement).~      Study participants are eligible if they are male or female with an age over 65 years and if~     their cognitive status as well as their physical fitness level allows to participate at the~     strength training sessions. Exclusion criteria comprise chronic diseases which~     contraindicate the medical training therapy, serious cardiovascular disease, diabetic~     retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and~     also regular strength training during the last six months.~      Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary~     outcome measures comprise anthropometric data, functional performance tests, immunological~     and oxidative stress parameters. The change in muscle signaling pathways will be assessed~     from muscle biopsies.~   "
97939|NCT01775098|"~     The objectives of the present study are to determine if starting treatement of hyperuricemia~     with allopurinol during an acute gout crises has an impact on the duration or the severity~     of the crises~   "
97940|NCT01775085|"~     The purpose of this study is to compare two types of groups for breast cancer survivors: a~     Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to~     deal with the emotional burden of having gone through the cancer experience. Participation~     in groups offering support often helps cancer survivors cope with stressors of life after~     having had cancer by giving them a place to express their feelings. The Meaning-Centered~     Group is intended to teach breast cancer survivors how to maintain or even increase a sense~     of meaning and purpose in their lives after treatment for cancer. The Discussion Group is~     intended to help breast cancer survivors cope by giving them a place to get support from~     other breast cancer survivors.~      The goal of this study is to compare the benefits of these two types of group approaches for~     breast cancer survivors. The study is also testing the benefits and feasibility of~     conducting the groups virtually using a telephone and computer.~   "
97941|NCT01775072|"~     The purpose of this study is to determine whether certain genes in cancer may be abnormal.~     When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not~     inherited (passed down from parents) but happen after birth in the cancer itself. Most~     cancers have many mutations. Some of these mutations are important for the cancer cells to~     survive while others are not. The goal of this study is test cancer for certain mutations~     using leftover tumor tissue from a previous surgery or biopsy. Participants will also be~     asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample~     that contains normal genes for comparison.~      The purpose of Part B of this study is to:~      Understand how genetic changes in tumor effect the chance of responding to experimental~     cancer treatment. Understand how the genes in the tumor change overtime in response to~     targeted cancer treatment.~   "
97942|NCT01775059|"~     This is a multi-center, non-randomized, and interventional study in which subjects will use~     the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm®~     VEO™ insulin pump (Sensor augmented pump) for 15 days.~      The purpose of this study is to collect performance data on the Integrated sensor and~     infusion set for approximately 15 days, with the intention for each subject to wear 5 sets~     for 3 days each.~   "
97943|NCT01775046|"~     The objective of this study is to assess the benefits of endovascular technique in terms of~     efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the~     treatment of thoracic aortic disease, in a cohort of patients representative of the~     population treated under real-life conditions of use in France for up to 5 years.~   "
97944|NCT01775033|"~     The overall goal of this project is to develop and evaluate an organized, regional system of~     pediatric emergency care in rural western Pennsylvania.~   "
97945|NCT01775020|"~     Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is~     impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival~     at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective~     in pigs for increasing NO production, restoring gut function, and inhibiting an increase in~     pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged~     intravenous L-arginine supplementation could therefore be useful in septic ICU patients.~   "
97946|NCT01775007|"~     A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the~     viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis~     is that the instrument can measure the Brillouin light scattering spectra from the eye~     safely and effectively from human subjects.~   "
97947|NCT01774994|"~     Investigation of arginine and NO metabolism in healthy subjects is important as a reference~     for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate~     the changes during aging and gender-related differences. Although data on arginine~     metabolism exist in literature, data are limited to young healthy male subjects. Since~     patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are~     often elderly and also women, knowledge of arginine metabolism in these groups is needed.~   "
97948|NCT01774981|"~     The purpose of this two-part study is to investigate the safety, tolerability and efficacy~     of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic~     nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will~     evaluate Proteinuria.~   "
97949|NCT01774968|"~     The main purpose of this study is to compare the effectiveness of Human Regular U-500~     Insulin three times a day versus twice a day.~   "
98005|NCT01774240|"~     Delirium is a common yet under diagnosed condition in hospitalized patients, and the~     incidence have not previously been described in Danish cardiac surgery patients. The present~     study seeks to describe the incidence and duration of delirium in this group of patients,~     before and after the introduction of standardized screening tool and a guideline for~     treatment of delirium after cardiac surgery.~   "
147995|NCT01117194|"~     The purpose is to study the effect of rehabilitation robot on shoulder training for stroke~     patients.~   "
97950|NCT01774955|"~     This is a multicenter, prospective, observational investigation, focusing of antiplatelet~     treatment in patients with moderate to high risk acute coronary syndrome (TIMI risk score~     ≥3)subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable~     hospitals in Greece. Data concerning patients' demographic, clinical/procedural~     characteristics and contraindications/special warnings and precautions to P2Y12 inhibitors~     are collected during initial hospitalization. Study involves 3 follow-up visits after~     hospital discharge(Day 30, at 6 months and at 12 months) where data on major adverse cardiac~     events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or~     CABG), bleeding events(according to Bleeding Academic Research Consortium criteria)and~     adherence to antiplatelet treatment are collected.~      In patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with~     VerifyNow assay will be performed at Day 30~   "
97951|NCT01774942|"~     Gum disease and type 2 diabetes are common chronic diseases that affect each other. Diabetes~     is increasing, especially in Pakistan. People with diabetes have a greater risk for gum~     disease. Also, it is thought that that gum disease, a chronic infection, can be a source of~     systemic inflammation and may contribute to poorer diabetes control.~      The aims of this project are to study:~        1. Changes in sugar control in people with type 2 diabetes and severe gum disease after~          having all teeth removed and replaced with Straumann dental implants and full dentures~        2. Changes in certain inflammation markers seen with insulin resistance and other diseases~          and conditions more common in people with diabetes~        3. Retention of dental implants in people with type 2 diabetes.~      The study will recruit 30 patients with type 2 diabetes and severe gum disease from Dr. Amin~     Rahman's private practices in Pakistan. Their long-term sugar (HbA1c) must be 7.5% or more~     and the inflammatory marker, C-reactive protein (hsCRP) 1mg/dL or more. Consenting~     participants will first have an oral examination. Eligible patients will have impressions of~     the jaws and the color of their teeth and gums recorded. At the next visit, all teeth will~     be extracted and dentures provided. One week later, there will be a check-up visit. Three~     months after the teeth were removed, Straumann dental implants will be placed in the jaws.~     After one week, the patient will be checked again. After three months, the dentures will be~     adjusted to fit the implants. Follow-up visits will occur every three months until one year~     after the implants were placed, then every six months for the next five years, to check the~     health of the patients as well as their implants, the gums around them, and the dentures.~     Blood samples will be taken at each follow-up visit.~      Our hypotheses are that levels of HbA1c and hsCRP will:~        1. decrease after extraction of all teeth~        2. not increase after placement of dental implants~        3. not increase after prosthetic restoration with full dentures anchored on the dental~          implants.~   "
97952|NCT01774929|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in participants with moderate (medium level~     of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder,~     which is seen mostly in older persons, in which the joints become painful and stiff).~   "
97953|NCT01774916|"~     Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular~     malformations in which arteries and veins are directly connected through a complex web of~     abnormal arteries and veins instead of a normal capillary network. Arterial feeders and~     enlarged draining veins directly connect through arteriovenous fistulas that create the~     nidus. The natural history of AVMs is organized into a clinical staging system: during the~     first phase of quiescence, the arteriovenous malformation mimics a capillary malformation.~     After many years, the AVM may enlarge with loco-regional expansion and tissular destruction.~     At the ultimate stage, AVM may impact the heart function. They are considered non malignant~     but can expand and become a significant clinical risk when extensive. The management of~     these high flow AVM remains often problematic. Complete and large surgical excision of the~     nidus after hyperselective embolization is the only potential therapeutic solution but this,~     is often difficult if not impossible. There is no pathogenetic hypothesis for the~     development of these malformations. Histopathological examination (performed only on~     surgical resection specimen) is poor and does not provide sufficient evidence to assess the~     evolutivity or the severity of the MAV. Recent data hypothesize that these vascular~     malformations are associated with alterations of the vascular endothelium caused by genetic~     abnormalities involved in the control of angiogenesis and vascular homeostasis. The~     detection of these anomalies allows the search for cellular and genetic markers that might~     be useful to optimize the clinical classification, staging, predicting the evolution of~     these defects and some understanding of its pathophysiological mechanisms. To our knowledge,~     no studies to identify cellular markers / genetic and endothelial associated with the~     development of cutaneous AVMs have been published to date.~   "
97954|NCT01774903|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in severe (very serious, life threatening)~     chronic (lasting a long time) low back pain in Thai participants.~   "
97955|NCT01774890|"~     The remarkable improvement in survival of children with congenital disease has led to a~     continuously growing number of adults with congenital heart disease in the developed world.~     Many of these patients had had cardiac surgery at early age, the may live for many years~     with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any~     combination of the above. These past and ongoing cardiac insults often result in significant~     cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and~     prognostic value for these patients.~      Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of~     biomarkers are used. In the last decade, our group has focused on the natriuretic peptides~     as markers for heart disease in infants and children. This resulted in many studies and more~     than 25 publications in the medical literature. We believe that the newly discovered cardiac~     marker, ST2, will emerge as an important addition to cardiac evaluation in the coming~     years.The aim of this study is to measure ST2 levels in patients with congenital right heart~     disease and correlate ST2 levels to clinical status, imaging and prognosis.~   "
97956|NCT01774877|"~     Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in~     Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the~     meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as~     soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic~     disease affecting more than 20 million people in the world.It is one of the most common~     forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which~     originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory~     ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed~     to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.~   "
97957|NCT01774864|"~     Study Design : multi-center, double-blind, placebo-controlled, randomized,~      parallel group, fixed dose design~      Phase : Phase III~   "
97958|NCT01774851|"~     To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more~     effective than paclitaxel and trastuzumab alone~   "
97959|NCT01774838|"~     To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute~     coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and~     different markers of inflammation, oxidative stress and platelet activation will be assessed~     in patients with unstable angina.~   "
114601|NCT01556386|"~     This study is to find out distribution of genetic polymorphisms and genes related to the~     chemotherapeutic drugs of ALL.~   "
97961|NCT01774812|"~     Despite advances in treatment of conventional cardiovascular risk factors, patients with~     kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects~     approximately 2 million Canadians; however, this patient population remains grossly~     understudied due to the complex nature of the disease. The inadequacy of the literature to~     address the cardiovascular-related mortality rates in those with kidney disease reflects the~     urgent need for investigation of novel risk factors.~      One cardiovascular risk factor which has recently been validated is the clinical measurement~     of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the~     stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in~     concert with one another to control heart rate. CAT can be quantified computer analysis of~     heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording.~     Abnormal CAT, which occurs when the autonomic system does not control heart rate properly in~     response to physical demands or stress, is associated with risk of adverse cardiovascular~     events in both healthy and high risk populations. It has recently been shown that patients~     with severe kidney disease demonstrate significant CAT abnormalities, thus exaggerated~     susceptibility to cardiac death.~      Vitamin D (VD) deficiency is also common in this patient population due to the fact that the~     kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established~     cardiovascular risk factor on its own, it is possible that kidney disease patients~     experienced compounded risk due to the combination of VD deficiency and abnormal CAT.~     However, no study has ever investigated whether VD deficiency influences CAT in healthy or~     diseased populations. To our knowledge, this will be the first trial to ever examine the~     effect, if any, of different VD supplementation treatments (standard of care vs.~     combination) on CAT in a population burdened with overwhelming risk and incidence of~     cardiovascular and sudden cardiac death risk.~   "
97962|NCT01774799|"~     This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among~     360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes~     (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly~     (up to 12-months) regarding goals of care preferences, advance care planning, and treatments~     received. The primary outcome is decisions not to be hospitalized at 6 months.~   "
97963|NCT01774786|"~     This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm~     study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab,~     fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive~     metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be~     randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks~     (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg]~     intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine~     (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will~     continue to receive pertuzumab or placebo and trastuzumab until disease progression~     occurrence of unacceptable toxicity or withdrawal from the study for another reason.~   "
97964|NCT01774773|"~     E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a~     single-center, randomized, open-label, cross-over manner. This study will consist of 2~     phases including pre-randomization (before drug administration) and postrandomization (after~     drug administration).~   "
97965|NCT01774760|"~     The results of previous studies suggest further development of [18F]EF5 as a PET tracer for~     imaging hypoxia. This is a non-randomized prospective study to obtain information on~     reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT~     scans.~   "
97966|NCT01774747|"~     Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety,~     tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and~     in subjects with major depressive disorder~   "
97967|NCT01774734|"~     1. Chronic neck pain is common in general population.~             -  High health care source expenditure~             -  Multiple therapeutic approaches available with limited evidence~             -  Previous studies showed active strengthening exercise improved pain (VAS) and~               functional performance (NDI)~             -  Muscle strengthening exercise with biofeedback technique showed more long-lasting~               effect in patients with chronic neck pain~        2. The investigators hypothesize that daily use of the neck strength exerciser (NSE),~          combined biofeedback technique with muscle strengthening exercise posture adjustment,~          in addition to traditional physiotherapy, could have more long-lasting and prominent~          effect on pain and functional improvement in patients with chronic neck pain.~   "
97968|NCT01774721|"~     This is a multinational, multicenter, randomized, open-labeled, Phase 3 study comparing the~     efficacy and safety of treatment with Dacomitinib (PF-00299804) to treatment with gefitinib~     in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal~     growth factor receptor (EGFR) activating mutation (s). Analyses of primary objective~     (Progression Free Survival) will be done as defined in the protocol.~   "
97969|NCT01774708|"~     Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be~     measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare.~     Measurement will be done using only pressure-sensitive mats that lie underneath the mattress~     and never touch the patient. PHI information will be collected by Emory staff. This PHI will~     be restricted to: age at time of participation; medical conditions; and medications. The PHI~     will be stored in a locked file behind a locked door. Data management will provide a unique~     identifier for each participant linked to a name that will be kept separately from the~     aggregate data.~      The data collected from the bed sensor will be processed offline and separately from the PHI~     to do proof of concept evaluation for the use of machine learning technology to predict bed~     exits 1 to 5 minutes ahead of time.~   "
97970|NCT01774695|"~     Increased physical activity has in the investigators recent study been shown to improve~     symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long~     term effects of the investigators previous intervention in IBS patients to improve physical~     activity. The investigators aimed to assess the long term effects on IBS symptoms as well as~     quality of life, fatigue, depression and anxiety.~   "
97971|NCT01774682|"~     The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional~     parameters of patients perambulation.~   "
98006|NCT01774227|"~     -  Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma~          management and is very easy to learn and easy to perform.~        -  Recent advances in laser technology; the role of TSCPC is being expanded because it has~          benefits of noninvasive glaucoma procedure.~        -  The titration (pops), the fixed high-energy, and the fixed-low energy~          (slow-coagulation) are three energy delivery techniques.~        -  The present study would report on the outcome (efficacy and safety) of the~          slow-coagulation versus the titration method in treatment of refractory glaucoma with~          dark iris.~        -  The results would provide reliable evidences to supplement clinical judgment when~          making a decision in favor of each treatment method for glaucoma patients.~   "
97972|NCT01774669|"~     The patient study is a phase III trial designed as a single-blinded, randomised, controlled~     multi-centre trial with repeated measurement events (ME). Patients will be evaluated by a~     blinded assessor on five occasions: twice within two weeks at baseline before intervention~     start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2),~     and once after a two month follow-up period (FU). Figure 1 illustrates the study overview.~      The study focuses on the evaluation of the YouGrabber efficacy compared to conventional~     therapy in an outpatient setting.~      Research question: Do patients after stroke in the YouGrabber training group show higher~     postintervention performance in the Box and Block Test (BBT) compared to patients in the~     conventional therapy group? Hypothesis: H0: The investigators hypothesise that there will be~     no group differences after 16 training sessions or after the two month follow-up period.~      H1: The investigators hypothesise that there will be a group difference after the 16~     training sessions and after the two month follow-up period.~      Aim: The aim of the project is to design and implement a single-blinded, randomised~     controlled multi-centre trial comparing YouGrabber training and conventional therapy in~     patients after stroke.~      Patients will be randomly allocated to either the experimental group (EG) or the control~     group (CG) after the second ME (T0). Group allocation will be based on a computer-generated~     randomisation list (one for each centre, (MATLAB, 2007b, Mathworks Inc., USA) created by a~     researcher not involved into the study. Randomisation lists and corresponding token will be~     stored in the clinics' pharmacy. Patients will draw a token before the first therapy~     session. The token will be marked and stored until study finalisation in the pharmacy.~      Group allocation will remain concealed for the independent assessor until study~     finalisation. Patients and treating therapists will be reminded not to talk about patient's~     group allocation with other therapists or participants.~      Patients in both study groups (EG, CG) will receive the same amount of 16 sessions lasting~     for 45 minutes each. During each therapy appointment patients can decide to stop the~     training at any time.~      Patients allocated to EG will have the opportunity to participate in two semi-structured~     interviews to evaluate their expectations and experiences with the virtual reality therapy~     with YouGrabber.~      Treating therapists will have the opportunity to participate in one focus group meeting to~     evaluate their experiences with the virtual reality training, its advantages and~     disadvantages. Interview and focus group participation will be voluntary.~   "
97973|NCT01774656|"~     The purpose of this study is to determine the proportion of subjects who have sufficient~     improvement in ventricular function after undergoing a standardized Left Ventricular Assist~     Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of~     the LVAD within 18 months.~   "
97974|NCT01774643|"~     This is a feasibility study to perform image-guided liver biopsies in 25 patients who have~     pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the~     liver). This will contribute with samples for the bio-bank (bank of tumors) and develop~     xenografts (human tumors growing in mice) for further analysis of genes.~   "
97975|NCT01774630|"~     Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal~     translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth~     and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor~     (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing~     durable responses. However, requiring continuing IM indefinitely and the ability of IM to~     eradicate the CML clone was uncertain.~      In a small proportion of patients, IM can induce complete molecular response (CMR) defined~     by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The~     question whether or not these patients are cured and can discontinue drug therapy has been~     assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely~     discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed~     after IM discontinuation mainly did it in the first 6 months and responded to reintroduction~     of imatinib.~      Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved~     target specificity over imatinib. Its efficacy and safety in the treatment of patients who~     are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led~     to the registration in second and first line treatment of CML-CP patients. Nilotinib~     produces even faster and deeper responses with more occurrence of CMR than does Imatinib.~     Consequently, one can assume that a more potent drug such nilotinib could induce deeper and~     sustained CMR allowing longer period off treatment than IM.~      The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in~     molecular relapse after IM discontinuation and to provide an estimation about duration of~     CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years~     of stable CMR with nilotinib.~   "
97976|NCT01774617|"~     It is a cohort to evaluate the power of different diagnostic tests in predicting the~     prognosis of patients with severe liver disease.~      Patients with decompensated liver cirrhosis on the waiting list for liver transplantation~     will be evaluated with comparison of different diagnostic tests according to the MELD score~     (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium),~     indocyanine green clearance test, hepatic venous pressure gradient and transient~     elastography. All patients will be submitted to all the tests and prospectively followed for~     6 months, to establish mortality and complications related to liver disease in order to~     define the value of each method to predict outcomes.~   "
97977|NCT01774604|"~     The purpose of this study is to assess whether peri-procedural administration of rectal~     indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.~   "
97978|NCT01774591|"~     The purpose of the research is to evaluate the effect of azilsartan medoximil on blood~     pressure and urinary aldosterone levels in postmenopausal females.~   "
97979|NCT01774578|"~     The purpose of this study is to assess overall survival of anti-tumor immunization using~     HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed~     non-small cell lung cancer (NSCLC) that have been previously treated.~   "
97980|NCT01774565|"~     The main study objective is to compare conventional insulin therapy with automated~     closed-loop glucose control in achieving target glucose levels in hospitalised~     insulin-treated T2D subjects over 72 hours (phase 1) and inpatient hyperglycaemia requiring~     subcutaneous insulin therapy up to 15 days (phase 2).~      This is an open-label, two-arm, randomised, parallel design study in hospitalised~     insulin-treated T2D subjects (phase 1) and inpatient hyperglycaemia requiring subcutaneous~     insulin therapy (phase 2), during which target glucose levels will be controlled either by~     closed-loop system combined with (phase 1 only) once daily basal insulin injection or by~     conventional insulin therapy in random order.~   "
97981|NCT01774552|"~     Port-wine stain is a congenital, progressive vascular malformation of human skin involving~     post-capillary venules that occurs in an estimated 0.3% of children and can alter~     personality development and psychological in children.~   "
97982|NCT01774539|"~     Children who suffer fractures to the growth plates (physes) of their bones are at risk for~     premature growth arrest which can lead to long term complications. There is currently no~     technique to predict who is at risk of growth arrest following a physeal injury. The~     investigators aim to determine if diffusion MRI (an imaging method to analyze tissue~     properties) can effectively pick up differences between a healthy growth plate and an~     injured one. This would allow orthopaedics surgeons to predict which injuries are at a~     higher risk of growth arrest, so earlier interventions can be done in the orthopaedic~     clinic.~   "
98007|NCT01774214|"~     The purpose of this study is to determine which of two commonly used methods of manual~     pediatric fluid resuscitation (The Push-Pull Technique vs. the Disconnect-Reconnect~     Technique) allows for the most rapid administration of normal saline when this is urgently~     required.~   "
98042|NCT01773798|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic~     (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in~     subjects with type 1 diabetes.~   "
97983|NCT01774526|"~     Lung Cancer continues to be the major cause of cancer-related mortality in Singapore.~     Non-small cell lung cancer (NSCLC) accounts for 75% of lung cancers and adenocarcinoma is~     the most common histological subtype. Although cigarette-smoking is the main cause of lung~     cancer, more than a third afflicted in Singapore are never-smokers and 69% affect females.~     For the majority who present with advanced NSCLC, chemotherapy is the mainstay of treatment.~     Despite advances made with newer chemotherapeutic agents, it is apparent that the benefit of~     conventional chemotherapy has plateaued. Efforts toward developing novel treatments based on~     growing understanding of molecular oncology have yielded drugs that target vascular~     endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). They have~     expanded treatment options for patients with advanced NSCLC. However, monoclonal antibody to~     VEGF is contraindicated in patients with squamous cell carcinoma due to increased incidence~     of fatal hemoptysis. EGFR tyrosine kinase inhibitors (EGFR-TKI) appear promising but only~     40% of east-asian female never-smokers with lung adenocarcinoma harbour EGFR gene mutations.~     Estrogen, KRAS, BRAF, ERBE and other genetic mutations can confound response. Molecular data~     obtained from Caucasian and predominantly east-asian population may not apply to our~     multi-ethnic groups and our aim is to determine the molecular characteristics of our~     multi-ethnic asian phenotypes to better understand the process of carcinogenesis and~     treatment response as well as identify potential novel targets for future drug development.~     Paraffin-embedded tissues are recalled, and DNA is extracted for mutational analysis, which~     will be correlated to patient demographics, treatment and outcome.~   "
97984|NCT01774513|"~     The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle~     with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis~   "
97985|NCT01774500|"~     We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal~     ranges can rule out seizure recurrences and severe outcome, and allow early discharge from~     the emergency department~   "
97986|NCT01774487|"~     The purpose of this study is to determine whether pentoxifylline reduces liver damage in~     infants with biliary atresia.~   "
97987|NCT01774474|"~     Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the~     last few years, several new treatments have been tried to address the problem of CME after~     cataract surgery in diabetic and non-diabetic patients. The investigators will perform a~     large RCT with the aim to provide more definite evidence-based recommendations for clinical~     guidelines to prevent the occurrence of CME after cataract surgery in patients with and~     without diabetes mellitus (DM).~   "
97988|NCT01774461|"~     The aim of this study is to investigate the effect of remote ischemic preconditioning on~     biochemical and functional indices of cardiac function induced by a 30 km run in healthy~     trained long distance runners.~   "
97989|NCT01774448|"~     People with dementia forget things and have trouble concentrating. In addition, they and~     their caregivers can become depressed. This project will show whether Mindfulness-Based~     Cognitive Therapy (MBCT) can lessen depression, increase attention spans and improve quality~     of life for those affected by the disease and their caregivers.~      MBCT combines intensive training in mindfulness meditation with Cognitive Behavioural~     Therapy. Studies show the meditation component creates changes in areas of the brain~     associated with our ability to pay attention. This form of meditation can help those~     impacted by dementia become more aware of their depressive thinking, leading to improved~     ways of coping.~      The investigators predict that individuals in the early stages of dementia and their spousal~     caregivers will report fewer depression symptoms following the 8-week Mindfulness-Based~     Cognitive Therapy (MBCT) Program, as well as experience improvements in quality of life and~     daily mindfulness.~      If successful, MBCT could improve the quality of life in individuals with dementia and their~     caregivers, as well as may take pressure off the health care system by delaying~     institutionalization.~   "
97990|NCT01774435|"~     This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation~     durations of 6 months.~   "
97991|NCT01774422|"~     The patients affected by severe chronic respiratory failure can develop hypercapnic~     decompensation leading to coma and death in a few hours. At present, the main treatment is~     noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum~     of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation~     impossibility, invasive mechanical ventilation is proposed to patients, which is an~     aggressive therapy. Regularly, the patients undergo this aggressive therapy without having~     expressed their opinion. Indeed, a great majority of these patients with severe respiratory~     insufficiency did not anticipate directives in case of respiratory decompensation~     (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still~     uncertain but certainly alters quality of life (discomfort, loss of autonomy…). After~     complete, clear, loyal and adapted information, a majority of patient do not wish to go on~     these aggressive therapies. At the time of the decompensation, the patients are incapable to~     express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover~     device, such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the~     patient to improve his state of consciousness and so to find the conditions of spontaneous~     ventilation required for the noninvasive ventilation. The DECAP CO2 device can be used to~     stop quickly the hypercapnic narcosis and to collect the wills of the patient on the choice~     of possible aggressive therapies. It is in this last condition that we wish to estimate the~     DECAP CO2 device.~   "
98008|NCT01774201|"~     Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory~     dysfunction due to weakness in the respiratory musculature has been described in MS. This~     leads to increased morbidity and mortality in late stages of the disease. It is possible~     that respiratory dysfunction influence physical fitness in earlier stages as well. Walking~     disability and fatigue causes significant impact on health in patients with MS, even in~     earlier stages.~      The hypothesis is that there is a relationship between respiratory function, walking~     capacity and fatigue and that daily deep breathing exercise during two months will improve~     respiratory function, walking capacity and fatigue.~   "
98009|NCT01774188|"~     EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ~     blood perfusion the same time. The present study investigated the impact of Enhanced~     Extracorporeal Counterpulsation treatment on the intraocular pressure.~   "
115330|NCT01546545|"~     This study is designed to determine whether a person's sensitivity to their own insulin~     varies from the morning to the evening.~   "
97992|NCT01774409|"~     It is a non-randomized, multicentric, cohort study, combined with a biological sample~     collection, a retrospective clinical data collection and with a genetic and immunologic~     biomarkers study.~      The ProfiLER program aims to implement a personalized cancer medicine approach by proposing~     to establish the genetic and immunologic profile of the tumor for patients with an advanced~     malignant tumor, in order to define a map of genetic (for the pre-identified target genes)~     and immunologic profiles for all the studied types of cancer. This study will also allow~     adapting the therapeutic management of these patients, if needed, by giving them targeted~     therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the~     recommendations of the multidisciplinary molecular board.~      The genetic and immunologic profile of the tumor will be determined from archival or fresh~     collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The~     correlation between genetic profiles of the tumor, patients immunity status and~     retrospective clinical data (progression, tumor response, etc.) collected from the patient~     medical records will probably allow us to identify biomarkers with a potential predictive~     value and to determine if some genetic disorders are linked to immunity status alterations.~   "
97993|NCT01774396|"~     Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with~     Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female~     patients with loss of fatty tissue in hands.~   "
97994|NCT01774383|"~     The ERD and ERS patterns of coordination between the STN and cortical regions in the~     termination of volitional movement in PD patients.~   "
97995|NCT01774370|"~     This is a prospective, non-interventional, open-label, multi-centre study. It will provide~     additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical~     settings.~   "
97996|NCT01774357|"~     This is an observational registry study aiming to collect data on efficacy and safety of the~     single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up~     period is 24 months. All analyses on the data will be done post-hoc; the study does not~     intend to confirm any pre-specified hypotheses.~   "
97997|NCT01774344|"~     This clinical study evaluates the efficacy and safety of regorafenib in patients with~     advanced liver cancer who have progressed on sorafenib treatment.~      Approximately 560 patients who meet the entry criteria will be randomly assigned in a 2:1~     ratio to regorafenib or placebo (1/3 chance to receive placebo).~      Primary endpoint of the study is overall survival.~   "
97998|NCT01774331|"~     Primary:~      • Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™)~     using infusion nurse measured physical, quality of life (QOL), respiratory, and disability~     assessments.~      Secondary:~        -  Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes.~        -  Change in IVIg dose and timing effects measured outcomes.~        -  Change in patient status is reflected in measured outcomes.~        -  Assess the value to physicians from infusion nurse collected outcomes data.~        -  Identify types of patients by response to IVIg therapy (i.e. natural or poor~          responders).~        -  Change in response rate to IVIg therapy by disease state and demographics.~   "
97999|NCT01774318|"~     Due to the development of neonatal intensive care the number of surviving premature infants~     increased significantly. The immature brain undergoes a fair amount of external stimuli,~     which have a great impact on later cognitive development. Increasingly data show, that a~     delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury.~     Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of~     gestation onwards. But a few studies show, that also extremely premature infants already~     show cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a~     time-compressed, simplified EEG) and conventional EEG. This might resemble early~     sleep-wake-states and their presence correlates to the integrity of the central nervous~     system, although no clearly defined sleep states according to the classical definition can~     be identified. Complex EEG analysis needs the use of automated methods to exclude personal~     bias and to ensure gestational age specific data analysis. The newly developed NLEO~     algorithm was specially designed for EEG analysis of premature infants. Conventional EEG~     within this study will be analyzed visually and with the automated algorithm. In our~     research project we will study the emergence of Sleep-wake-cycling in extremely premature~     infants and its impact on their neurodevelopmental outcome prospectively. The different~     sleep and wake states will be derived from analysis of the conventional Video-EEG, aEEG and~     polysomnographic measurements. Visual analysis will include assessment of amplitudes and~     frequencies as well as the latencies and durations of EEG-Bursts and Interburst intervals.~     The automated NLEO-algorithm will be firstly used for comparison with above described visual~     analysis and secondly to find regions of interest involved in the organization of these~     early sleep states. The aim of this study is first to understand and analyze in detail the~     emergence of sleep-wake cycling including its disturbances in premature infants and to~     compare automated NLEO algorithm to conventional visual analysis methods. Secondly to~     correlate neurodevelopmental outcome to the emergence of sleep-wake-cycling.~   "
98000|NCT01774305|"~     Coughing during emergence from general anaesthesia may lead to dangerous effects including~     laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4%~     of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α~     adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic~     reflexes during emergence from anaesthesia.~      In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of~     surgery reduces coughing during extubation after thyroidectomy.~   "
98001|NCT01774292|"~     The purpose of the study is to determined whether the administration of alkalized 4%~     lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence~     of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous~     oxide as an anesthetic agent.~   "
98002|NCT01774279|"~     Anaplastic thyroid cancer has historically proven very difficult to research due to a~     combination of its rarity and the associated short survival period for those affected. In~     2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be~     the anaplastic subtype 1,2. For these patients average life expectancy is in the range of~     2-6 months with only a very small number surviving for more than one year. It is a highly~     aggressive form of cancer that is refractory to current treatment options. By collecting~     tissue and blood samples along with clinical data across the UK we will be able to~     accumulate numerically significant numbers of samples and data points which will facilitate~     research opportunities. Researchers will be encouraged to apply for access to the collected~     samples in order to try and establish the causal mechanisms for disease development,~     potential therapeutic targets and to relate clinical course and outcome with specific~     molecular defects. Due to the rarity it is not feasible for a single cancer centre or cancer~     network to accumulate sufficient samples for research in a meaningful timeframe hence the~     need for national collaboration in order to try and offer patients with this disease hope in~     the future.~      All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is~     expected to run for at least 5 years and all thyroid cancer clinicians will be encouraged to~     participate. Patients will be asked to donate surplus thyroid cancer tissue following~     routine biopsy procedures along with an optional blood sample.~      2. Objectives~      Primary Objectives The primary objective of this project is to establish a national~     anaplastic thyroid cancer tissue collection to help facilitate both basic and translational~     research opportunities.~      There is no direct research question that the project itself addresses at this stage. The~     research proposals that subsequently arise as a result of this project will be generated by~     accredited research parties from the UK and potentially internationally. These research~     proposals will be submitted to the National Anaplastic Thyroid Cancer Tissue Bank and~     Database Project (NATT) Steering Committee for assessment. As the volume of material~     collected per patient is expected to be of small volume, by virtue of the specimen~     comprising core biopsy or fine needle aspirate material, research proposals will need to be~     prioritised according to the potential benefits the proposed research offers. Priority will~     be given to projects that may lead to the identification of potential therapeutic targets.~     Each research proposal will require their own ethical approval and research and development~     assessments before commencing.~      The steering committee will be multidisciplinary and will include nationally respected~     researchers and thyroid cancer clinicians.~      Scientific Justification The long term objective is to try and address the current lack of~     understanding about the aetiology and progression of this disease and ultimately to develop~     new therapeutic interventions that may slow the rate of disease progression, improve quality~     of life and prolong what is currently a very short survival.~      Due to the short prognosis following diagnosis it is notoriously difficult to run~     interventional therapeutic clinical trials in this patient population. Patients usually~     present with locally advanced and metastatic disease and as a consequence are often of poor~     performance status making clinical trial participation very problematic. If potential~     therapeutic targets could be identified in vivo it would potentially open up new therapeutic~     avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment.~      This is a unique project within the setting of anaplastic thyroid cancer research.~   "
98003|NCT01774266|"~     In this proposal the investigators aim to develop a commercial kit to be used in primary~     screening and non-invasive triage for early detection of gastric cancer. This kit will be~     cost-effective and more accessible to the general population. In addition, the investigators~     would like to expand our current patent already submitted to INAPI (National Institute for~     Intellectual Property) and propose royalties to biomedical diagnostic companies for the use~     of our product at international level.~   "
98004|NCT01774253|"~     The purpose of this research study is to evaluate an investigational drug (Vismodegib) for~     Pontine Glioma that is growing or has come back (reoccurred). This study will look at the~     tumors response to the study drug, Vismodegib, and will also look at the safety and~     tolerability of Vismodegib.~      Vismodegib has been tested in multiple adult clinical trials and one pediatric trial.~     Laboratory testing in pontine gliomas suggests that this drug may be effective in treating~     this disease.~   "
98010|NCT01774175|"~     The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate~     about bowel preparation, patient's satisfaction, side effects to identify effectiveness of~     new bowel preparation drug.~   "
98011|NCT01774162|"~     Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many~     gastrointestinal conditions, including but not limited to, malignant and pre-malignant~     neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the~     gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions~     within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy~     method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that~     enables a small needle to be passed into the lesion of interest under ultrasound guidance,~     obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis~     of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in~     certain clinical circumstances, it is more desirable and sometimes necessary to obtain a~     core tissue biopsy for histology rather than the cellular material for cytology obtained~     with EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA~     compared to cytology. It is with these aims in mind that a new type of needle, the fine~     needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a~     comparison of these to methods has yet to be made, the aim of this study is to perform a~     direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle~     with the conventional EUS-FNA needle.~   "
98012|NCT01774149|"~     Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers~     a large amount of data on their disease. The study intends to see if giving advanced~     feedback on these data can improve their blood glucose management.~   "
98013|NCT01774136|"~     This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a~     Community-Integrated Management of Childhood Illness (C-IMCI) training for community~     caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of~     maternal, newborn and child health interventions within households in rural communities in~     Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two~     components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and~     supervisors, and (2) continuous support and supervision following the continuous quality~     improvement (CQI) framework, a low-technology approach to management and supervision of~     health programs. The primary objectives of the proposed evaluation are to measure the effect~     of the intervention on key outcomes, including early uptake of antenatal care, facility~     based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR~     testing in infants at 6 weeks. We will also examine the effects of the intervention on~     immunization uptake up to 12 months and knowledge and practices of CCGs and mothers~     pertaining to maternal, newborn and child health.~   "
98014|NCT01774123|"~     To evaluate the ability of different spectral domain optical coherence tomography (OCT)~     devices, as well as different acquisition and analysis packages, to detect disease~     progression in patients with multiple sclerosis with and without a history of optic neuritis~   "
98015|NCT01774110|"~     A. Specific Aims:~      1. There is one specific aim of this study. The aim is to evaluate the effectiveness of~     early standardized task-specific training (ESTT) in persons with acute stroke.~      B. Hypothesis:~      1. It is our hypothesis that subjects who receive ESTT will walk faster and more~     symmetrically than published reports of gait outcomes in persons with stroke.~   "
98016|NCT01774097|"~     The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells~     taken from a patient's bone marrow can be placed safely, via intramuscular injections, into~     their affected calf and lower thigh muscles and improve blood flow and/or peak walking time~     in patients experiencing pain associated with blocked blood vessels in the leg.~   "
98017|NCT01774084|"~     The purpose of this study is to determine whether preload of carbohydrate or water before~     elective hip replacement improve insulin sensitivity and or beta cell function in human.~   "
98018|NCT01774071|"~     The purpose of this study is to see if a new diagnostic research agent named~     89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long~     89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an~     antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached~     to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by~     a PET scanner. The results of this study may help researchers know whether~     89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have~     STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate~     cancer cells is that new therapies are being developed to target STEAP1 prostate cancer~     cells.~   "
98019|NCT01774058|"~     A prospective case-control study was performed to investigate the effect of iloprost on the~     intraoperative flow volume in diabetic and non-diabetic patients as well as the effect of~     peripheral neuropathy in patients with peripheral arterial occlusive disease (PAOD)~     undergoing arterial reconstruction (primary endpoint).~      100 patients undergoing femoral artery reconstruction or femorodistal bypass surgery were~     included. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow~     volume at the common femoral artery was assessed using a Doppler flowmeter (Sono TT FlowLab;~     ) before reconstruction, prior to the intraarterial application of 3000ng of iloprost and 5~     and 10 minutes afterwards. Peripheral resistance units (PRU) were calculated as a function~     of mean systemic arterial pressure (MAP) and flow volume (VF): PRU = MAP (mmHg) / VF~     (ml/min).~   "
98020|NCT01774045|"~     The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,~     find the effective adequate dose for the next stage of the study, and accumulate information~     of possible mechanism of its anti-depressive effect.~   "
98021|NCT01774032|"~     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic~     influenza vaccine in a Japanese elderly population aged 65 years and older.~   "
98022|NCT01774019|"~     The purpose of this study is to demonstrate that preoperative biliary drainage using~     self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in~     patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary~     cancer.~   "
98023|NCT01774006|"~     Prospective randomized comparison of two widely used in vitro culture system in human IVF~     treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media~     droplets using conventional petridish or in group culture using WOW (well of the well)~     petridish.~      Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and~     embryo quality~   "
98025|NCT01773980|"~     The goal of this project is to develop and pilot test an innovative approach for overcoming~     barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon.~     Many studies have shown that people with disabilities receive fewer indicated cancer~     screening services and are more likely to have poor cancer-related outcomes, such as late~     stage at diagnosis, compared to those without disabilities.~   "
98026|NCT01773967|"~     The investigators will study the efficacy and side effect profile of LGG, a probiotic, in~     pediatric patients with acute gastroenteritis.~   "
98027|NCT01773954|"~     To evaluate the visual outcome and number of injections required during an optical coherence~     tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment~     of subfoveal neovascular age-related macular degeneration (NVAMD).~   "
98028|NCT01773135|"~     The aim of this study is use of ACTH as a predictive marker in patients of threatened~     preterm labor .~   "
98029|NCT01773122|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in~     subjects with acne vulgaris following 28 days of dosing.~   "
98030|NCT01773109|"~     This Phase 2 study is designed to characterize the objective response rate (defined as~     complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to~     subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37~     eligible subjects will receive the investigational drug q3 weeks until they are no longer~     benefiting.~   "
98031|NCT01773096|"~     The purpose of this study is to determine whether the routine use of methylnaltrexone in the~     post-operative pediatric spinal fusion patient will decrease the incidence of constipation.~   "
98032|NCT01773928|"~     The purpose of this study is to determine if a Vero cell-derived trivalent seasonal~     influenza vaccine produced by the modified manufacturing process:~        1. induces immune responses comparable to that produced by the current manufacturing~          process~        2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza~          vaccine~        3. demonstrates consistency of immune response among three different lots.~   "
98033|NCT01773915|"~     Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the~     elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples~     have demonstrated to discriminate to some extend between AD and non-AD individuals based on~     the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins~     whose levels increase during the Braak Stages of AD that are accessible in other body fluids~     such as blood, urine or saliva. The detection of these proteins would allow performing~     simple tests in case its levels were confirmed to be associated with the AD pathology.~   "
98034|NCT01773902|"~     Although expressed breast milk is considered the optimal nutritional source for preterm~     infants, the macronutrient content is insufficient to enable optimal growth during neonatal~     intensive care. Optimal dose and optimal mode of administration (standardized or~     individualized) of enteral protein supplementation to very preterm infants have not been~     established.~      This study aims to compare the effects on weight gain of different modes of enteral protein~     supplementation.~   "
98035|NCT01773889|"~     This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin~     diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells~     (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial~     ovarian cancers, enhancing treatment efficacy.~   "
98036|NCT01773876|"~     Invasive Candida infections are burdened with a high mortality rate and is very common in~     intensive care units. This study aims to evaluate the efficacy of empirical treatment with~     micafungin in adult patients with suspected invasive candidiasis.~   "
98037|NCT01773863|"~     Community-acquired pneumonia is the most common infection leading to hospitalization in~     intensive care units and the most common cause of death associated with infection disease.~      Epidemiological studies have shown that respiratory tract infections are associated with an~     increased risk for the development of acute cardiovascular and cerebrovascular events.~      This link is further supported by studies indicating that influenza vaccination is~     associated with a reduced risk of hospitalization for pneumonia as well as heart disease and~     cerebrovascular disease.~      Data connecting acute respiratory tract infections and cardiovascular events stem almost~     exclusively from cross-sectional or retrospective studies. Thus the real incidence and the~     prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia~     and cardiovascular damage is still elusive.~      Inflammation plays a major role in the pathogenesis of coronary artery disease. The~     increased concentrations of proinflammatory cytokines together with the activation of~     coagulation, the down-regulation of anticoagulant mechanisms and the enhanced platelet~     aggregation may trigger atheroma's instability, plaque rupture and thrombus formation.~      Inflammation and coagulopathy are also considered universal host responses to infection in~     patients with severe sepsis. Thus far limited data are available on the changes in these~     high regulated systems, together with platelet activity in patients with CAP and their~     potential relationship with cardiovascular risk.~      This project will consist in a prospective multicenter study to investigate the incidence of~     major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP,~     its prognostic relevance and the potential relationship between enhanced cardiovascular risk~     and the activation of inflammation, coagulation and platelet aggregation in this setting.~   "
98038|NCT01773850|"~     The goal of the study is to compare the radiologist confidence level in evaluating patients~     with known breast lesions using a carbon nanotube x-ray based stationary breast~     tomosynthesis imaging device. The comparison will be made against conventional mammography~     acquired as a part of a standard clinical workup. One hundred patients who are to have a~     clinical surgical breast biopsy will be recruited for the study. A reader study will be~     performed to evaluate the ROC characteristics of the system.~   "
98039|NCT01773837|"~     Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional~     capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central~     nervous system stimulant that has traditionally been used in cancer patients to manage~     depression, opioid‐induced sedation, hypoactive delirium due to multiorgan failure, and~     cognitive disorder associated with brain tumors. Although there is evidence from prospective~     studies of the efficacy of this drug in cancer‐related fatigue, the only one randomised~     clinical trials gave non-conclusive results. In order to define the real efficacy of~     methylphenidate in this setting, the investigators designed a new clinical trial comparing~     methylphenidate and placebo in cancer‐related fatigue, assessed both by the verbal numeric~     scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for~     fatigue of the Functional Assessment of Cancer Therapy (FACT‐F). The investigators will~     include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin~     ≥ 9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted~     to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day.~     Assessment of response will be performed on day 3 and day 6 with ESAS and FACT‐F.~     Drug‐induced adverse events will be checked. The VNS of fatigue on day 6 will be consider~     the primary endpoint.~   "
98044|NCT01773772|"~     The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH)~     and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the~     investigators aim to discover whether or not giving 2 small doses of progesterone to early~     pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the~     information gathered in this study, the investigators may be able to learn more about how~     menstrual cycles are normally established in girls during puberty. Ultimately, if these~     normal processes can be understood, the investigators may be able to better understand~     abnormalities of puberty.~   "
98045|NCT01773759|"~     Ensuring that all children are fully immunized against vaccine-preventable diseases is a~     critical public health issue. Child care programs are critical targets for efforts to~     increase the proportion of infants and young children who are fully immunized. The primary~     objective of this proposal is to rigorously examine current state, local government, and~     child care providers' efforts and barriers to ensuring that all enrolled children are~     up-to-date for required immunizations and to evaluate strategies to improve immunization~     coverage in child care programs.~   "
98046|NCT01773746|"~     The most appropriate initial oxygen concentration for the resuscitation of the extremely low~     birth weight infant has not been established using large well designed, randomized, blinded,~     prospective trials and the level of oxygen utilized by practitioners in this situation is~     highly variable. This proposed trial will use targeted oxygen saturation levels over the~     first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the~     resuscitation of such infants, and will be large enough to evaluate short term outcomes of~     survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the~     long term outcome of survival without significant neurodevelopmental impairment at 2 years~     of age. Such information is urgently required to provide an evidence basis for the initial~     oxygen concentration for resuscitation of these very preterm infants.~   "
98047|NCT01773733|"~     The aim of this study is to summarize the data on efficacy and safety of Reduxine~     administration in the routine clinical practice according to the approved indications.~   "
98048|NCT01773720|"~     The aim of our study was to evaluate the reliability of uncalibrated cardiac index~     monitoring based on arterial waveform analysis in patients undergoing off-pump coronary~     artery bypass grafting.~   "
98049|NCT01773707|"~     The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.~      All subjects will receive close monitoring for development of AGT or T1DM. Subjects will~     receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess~     the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.~      The primary objective is to determine whether intervention with Abatacept will prevent or~     delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of~     patients with T1DM.~      Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of~     C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic~     outcomes.~   "
98050|NCT01773694|"~     Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is~     likely to decrease the risk of infection and bleeding. However, this has never been formally~     studied. Patient's routines are likely disrupted when they are asked to avoid wetting the~     area. The investigators will perform a controlled study to determine if avoidance of~     post-operative wetting is necessary.~   "
98051|NCT01773681|"~     The purpose of this study is to use magnetic resonance imaging (MRI) and high-resolution~     peripheral quantitative computed tomography (HR-pQCT) techniques to look at the damage and~     disease activity progression in the hand and wrist joints of patients with rheumatoid~     arthritis.~      The central hypothesis is that ongoing erosions and cartilage loss in rheumatoid arthritis~     are due to persistent inflammation, which is poorly detected by clinical examination and~     markers of systemic inflammation.~   "
98052|NCT01773668|"~     The purpose of this study is to collect performance data on the Integrated sensor and~     infusion set during 3 days of use and demonstrate performance adequacy of the integrated~     sensor and infusion set with glucose sensing and insulin delivery functionalities. The~     hypothesis of this study is that having the infusion of insulin in close proximity to the~     sensor does not interfere with the sensor accuracy. This study focuses on high bolus~     patients. A high bolus is defined as 12 units or more.~   "
98053|NCT01773655|"~     The goal of this protocol is to determine the prevalence of somatic and germline mutations~     in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus,~     primary uveal melanoma (UM), or metastatic UM seen at our institution.~   "
98054|NCT01773642|"~     With increased availability of antiretroviral therapy (ART) and improved care, increasing~     numbers of perinatally infected children are surviving into adolescence. While HIV care and~     treatment programs are expanding, growing challenge faced by health providers and caregivers~     is diagnosis disclosure to HIV infected children.~      The investigators propose a 4 year project to test the effectiveness of a~     cognitive-behavioural intervention that the investigators have designed to support~     developmentally appropriate disclosure to HIV infected children by their caregiver.~      The investigators hypothesize that the intervention will lead to increased disclosure rates~     and will over time improve health and mental health outcomes among caregivers and children~     in the intervention group compared to those receiving standard care. The findings of the~     study will inform Ugandan and other countries' national policies on pediatric HIV care and~     treatment.~   "
98055|NCT01773629|"~     The investigators will evaluate effects of introducing the care manager on:~        1. Patient receipt of timely diagnosis and initiation of treatment for major depression~          (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and~        2. Patient continuity of care for depression across the transition of care from pregnancy~          to postpartum (within 4 months postpartum).~   "
98066|NCT01773486|"~     This study will examine whether hesperidin, a major component of citrus fruits, affects how~     the body responds to insulin in healthy and obese people. Laboratory studies suggest that~     hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow.~     This study will see if hesperidin improves insulin resistance or insulin's effects on blood~     flow in people with insulin resistance.~      Healthy normal weight or overweight people between 21 and 65 years of age may be eligible~     for this study. Participants are randomly assigned to take hesperidin or a placebo (inactive~     dummy pill ) for a 4-week treatment phase.~   "
98056|NCT01773616|"~     The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE)~     remains a challenge, particularly when there is renal involvement (lupus nephritis). For the~     last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but~     they are associated with significant toxicity.~      Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus~     nephritis did not meet their primary end-points, there is accumulating data that suggests~     that B cell depletion with Rituximab may be efficacious in lupus disease refractory to~     conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to~     mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a~     renal response as the standard of care therapy comprising MMF and high dose oral~     corticosteroids.~      RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial~     that aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in~     treating a new flare of lupus nephritis and whether it has a long lasting steroid-sparing,~     beneficial effect with equal efficacy and greater safety than a conventional regimen of MMF~     and oral prednisolone. If successful, this trial has the potential to dramatically change~     the management of lupus nephritis.~   "
98057|NCT01773603|"~     Choosing the best embryo for transfer has become the major challenge in in vitro~     fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has~     added embryo development kinetics as another selection criterion.~      This study was designed to select for the top blastocyst to be replaced, while increasing~     the pregnancy chance, with the local legislation regulating the number of embryos to be~     transferred and to establish a morphokinetic standard to be used in our clinical setting.~   "
98058|NCT01773590|"~     The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and~     Th2 mediated inflammation) and virus infection in the development of asthma, as well as the~     risk and severity of acute exacerbations of asthma. Understanding these mechanisms should~     identify new approaches for novel therapies for the prevention of asthma development and for~     prevention/treatment of asthma exacerbations. Such treatment has potential to have a major~     impact on patient quality of life and to result in enormous reductions in health care costs.~      A human model will be used to identify dysregulated genes/proteins and determine~     relationships with disease outcomes. This study will compare lower airway responses between~     asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection~     (subjects will be infected with rhinovirus as part of the study). This will have the dual~     advantage of investigating mechanisms in the most natural model possible, as well as~     developing a better model for testing novel therapeutic approaches. The investigators will~     analyse the samples from both subject groups, to determine their relevance to the human~     disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the~     human model will be very strong candidates for immediate translation into human intervention~     studies.~      Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study.~     These subjects will be ineligible to enter the main study due to the presence of~     neutralizing antibody to RV16 (~50% of subjects otherwise suitable for the study). These~     subjects will meet all other inclusion/exclusion criteria for the main study. The 12~     participants will undergo tests including a single bronchoscopy, nasal sampling and blood~     tests allowing for optimisation of all sample processing techniques. They will not be~     infected with RV-16.~      In the main study the investigators will aim to study up to 15 healthy volunteers and 15~     volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a~     single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following~     infection with the virus participants will be required to attend for regular sample~     collection including 2 further bronchoscopies post-infection. Patients will be followed~     until convalescence 6 weeks post infection.~   "
98059|NCT01773577|"~     Goal: To evaluate the effects of Interoperable Health IT on provider work flow and work~     practices in the ambulatory care setting.~      Interoperable health IT can produce a reduction of barriers in the exchange of health~     information that can allow for more efficient, timely, and a higher quality of patient care.~     This study seeks to evaluate the effects of the implementation of interoperable health IT on~     the work flow of medical providers in the care environments in which they are implemented.~   "
98060|NCT01773564|"~     Intravascular devices in intensive care units are often associated to complications. The~     investigators estimate that 23.5% of catheters placed and used in intensive care are subject~     to at least one complication; the investigators goal is to demonstrate the effectiveness of~     the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of~     complications associated with intravascular catheters in intensive care.~   "
98061|NCT01773551|"~     The purpose of this research study is to investigate whether breast density measured by a~     safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can~     detect the decrease of breast density in subjects who receive tamoxifen when compared to~     patients who do not receive any drug. If decreased density can be reliably detected, it may~     help determine which subjects will benefit by taking tamoxifen or other chemoprevention~     drugs.~   "
98062|NCT01773538|"~     The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be~     used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with~     cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can~     serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the~     Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).~   "
98063|NCT01773525|"~     The purpose of this study is to test the use of a tool (NOTSSdk)to assess and provide~     feedback to trainee surgeons' non-technical skills. It focuses on two aspects: reliability~     of ratings of trainee surgeons using NOTSSdk; and the content and quality of feedback given~     to trainees based on observations using NOTSSdk.~   "
98064|NCT01773512|"~     -  The prediction of extent and risk profile of coronary atherosclerosis based on clinical~          evaluation and non-invasive techniques.~        -  Detailed analysis of plaque volume, plaque composition, risk plaque features and shear~          stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel~          reconstruction.~        -  Prediction of changes in coronary arteries based on changes in non-invasive~          examinations.~        -  Examination of WSS influence on atherosclerosis development and changes of WSS during~          lipid lowering therapy.~   "
98065|NCT01773499|"~     Skin and soft tissue infections represent a tremendous burden to the health care community~     with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in~     2005. A Cochrane review of cellulitis found that there is limited data to support any~     specific antibiotic or even a specific length of antibiotic therapy, and that outpatient~     therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility~     in differentiating cellulitis from abscess but its role in patients with cellulitis is not~     well developed. Although speculative, the investigators hypothesize that sonographic~     features of cellulitis are associated with clinical improvement and successful therapy~     following antibiotics for patients with cellulitis.~   "
98067|NCT01773473|"~     The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25~     (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with~     Type 2 diabetes mellitus (T2DM).~   "
98068|NCT01773460|"~     Everolimus will be given to patients with metastatic breast cancer who already has a~     progress taking Everolimus but with a change in the endocrine treatment.~   "
98069|NCT01773447|"~     The investigators hope to compare two different methods of closing skin wounds using~     sutures. One of these methods (the set-back technique) was recently described in 2010 and~     has been reported to be technically easier and reduces the chance of spitting sutures (deep~     sutures that are pushed to the surface of the skin as the wound heals). The other method~     (the vertical mattress technique) has been used for many years with good results. However,~     no controlled studies have been performed to clearly demonstrate a difference between the~     two methods. We hope to find differences in the height of the wound edges immediately after~     surgery(5 minutes following the procedure) as well as the appearance of the scar and~     symptoms associated with the scar 3 months after surgery.~   "
98070|NCT01773434|"~     This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects~     with solid tumors. Subjects may have any solid tumor without intracranial involvement or~     metastases that has failed standard chemotherapy.~      This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of~     this study to assess the tolerability and the safety profile of MORAb-004. Dose will~     escalate in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a~     4-week cycle with no intra-subject escalation. Individual participants may have additional~     cycles at the same dose until disease progression unless the participants meet the~     discontinuation criteria.~      2) Part 2 will comprise cohort expansions to further characterize the safety and~     tolerability of MORAb-004 and to assess preliminary efficacy and the~     pharmacokinetic/pharmacodynamic relationship of MORAb-004 in gastric cancer and~     hepatocellular carcinoma (HCC). Three dose levels will be expanded based on the safety~     profile that was obtained in the dose escalation portion of this study (Part 1): 4 mg/kg~     (administered on a weekly basis), 8 mg/kg (administered on a weekly basis) and 12 mg/kg~     (administered every OTHER week).~   "
98071|NCT01773421|"~     This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of~     MTD for BID Dosing).Part A will be initiated first, and Part B will be initiated after the~     PK results of Part A have been evaluated.~   "
98072|NCT01773408|"~     This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of~     escalating doses of RO5503781 as a single agent or in combination with cytarabine in~     participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in~     escalating doses as a single agent, and in Part 2, RO5503781 will be administered in~     combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with~     cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic~     profile of an optimized formulation of RO5503781 in combination with cytarabine will be~     assessed.~   "
98073|NCT01773395|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational intervention to learn whether the intervention, in this~     case, the GVAX vaccine, works in preventing your MDS or AML from relapsing after your~     allogeneic stem cell transplantation. Investigational means that the vaccine is still~     being studied and that research doctors are trying to find out more about it-such as the~     side effects it may cause, and if the vaccine is effective. It also means that the FDA has~     not yet approved the vaccine for your type of cancer.~      You are being asked to participate in this trial because you have advanced myelodysplastic~     syndrome (MDS) or acute myeloid leukemia (AML). Your doctor has determined that you are a~     candidate for an allogeneic stem cell transplant as treatment for your MDS/AML. Allogeneic~     stem cell transplantation is a standard treatment for MDS/AML. It can be effective because~     the cells from your donor (also known as the graft) could form a new immune system that can~     fight against the MDS/AML cells in your body. This is also known as the~     graft-versus-leukemia or GVL effect. In patients with advanced MDS or AML that is not in~     remission at the time of transplantation, as in your case, relapse remains the number one~     cause of transplant failure. As such, this clinical trial is designed to assess whether~     adding a leukemia vaccine early after transplantation could stimulate donor cells to fight~     your cancer and improve transplant outcomes.~      In recent years, researchers at the Dana-Farber Cancer Institute have discovered that GVAX,~     a vaccine made from the patient's own cancer cells engineered to produce a protein called~     GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.~     GM-CSF is a naturally occurring hormone in the body that helps the immune system fight~     infections and diseases. The GVAX vaccine is made in the laboratory by using a virus (called~     adenovirus, which has been modified so it cannot cause illness) to insert the GM-CSF gene~     into tumor cells. The cells are then irradiated, which prevents them from being able to~     grow, before being administered to patients in a series of vaccinations.~      A previous phase I clinical trial using this GVAX vaccine in patients with MDS/AML after~     allogeneic transplantation demonstrated that the GVAX vaccine is safe, and the survival~     outcomes were encouraging. The current randomized phase II study will investigate this~     vaccine further and gather more information to assess the activity.~      If you participate in this research study, you will be randomized to receive either GVAX~     vaccination or placebo (a saline solution) vaccination. Randomization means that you are put~     into a group by chance. It is like flipping a coin. There is a 50% chance that you will~     receive the GVAX vaccine and a 50% chance you will receive placebo. Neither you nor your~     transplant doctor(s) will know which you will be receiving.~      The primary goal of this trial is to assess if there will be a difference in the percentage~     of cancer free survivors in the vaccinated vs. placebo group at 18 months after transplant.~   "
98074|NCT01773382|"~     The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight~     reduction. The investigators hypothesized that benefits of weight loss may reduce~     proteinuria.~   "
98075|NCT01773369|"~     Early childhood injuries such as perinatal (around birth) stroke are devastating because the~     child lives with the problem for life, typically close to a normal lifespan. One~     'opportunity' presented by a brain injury early in life compared to later in adulthood is~     that the young brain is much more plastic (malleable) and receptive to interventions. This~     is particularly true for neural circuits that are still under development. We will test the~     hypothesis that early (<2 yr old), intensive leg training will improve walking more than no~     training or training at >2 yr old. We will further determine the changes induced by training~     in motor and sensory pathways.~   "
98076|NCT01773356|"~     The objective of this study is to test the effect of dihydrocapsiate on energy expenditure~     in women.~   "
98077|NCT01773343|"~     To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with~     1 versus 3 months intervals~   "
98078|NCT01773330|"~     This study is using a new technology known as high resolution manometry which is used to~     evaluate patients that have trouble swallowing or have chest pain that is not related to the~     heart. The investigator wants to learn how the different positions of the body, in a lying~     position, semi-recumbent, sitting position or standing up, and the amount of liquid affects~     the outcome of the test. This will help the investigator to determine a standardized~     protocol for patients with trouble swallowing.~   "
98093|NCT01773070|"~     A follow up study designed to obtain long term data on subjects who either achieved a~     sustained virologic response or did not achieve a sustained virologic response in an Abbott~     sponsored hepatitis C study.~   "
98094|NCT01773057|"~     The purpose of this study is to determine whether the computerized decision support system~     'NHGDoc' is effective in improving quality of primary care in terms of processes of care~     (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital~     admissions, mortality).~   "
98079|NCT01773317|"~     A prospective randomized controlled trial will be used to evaluate the efficacy of~     post-operative perturbation training. 80 patients who were regular participants in~     activities that involve cutting, pivoting, jumping, and lateral movements prior to injury~     who range in age from 14-40 at the time of injury are eligible. All eligible subjects must~     undergo anterior cruciate ligament reconstruction by a single surgeon using quadrupled~     hamstring autograft or soft tissue allograft and the designated preoperative and~     postoperative rehabilitation at University of Delaware Physical Therapy clinic. Using a~     prospective randomized design, 40 subjects who received University of Delaware Physical~     Therapy post-operative treatment protocol will be block randomized by sex to 40 patients who~     will receive 10 sessions of post-operative perturbation training in addition to standard~     agility and return to activity progression and forty who receive only standard agility and~     return to activity progression. Post-operative perturbation training will be initiated when~     the athlete is at least 8 weeks post-anterior cruciate ligament reconstruction, has full~     range of motion and achieves 80% quadriceps strength symmetry, the criteria we currently use~     for beginning return to activity progression.~   "
98080|NCT01773304|"~     The purpose of this randomized, controlled, cross over single meal study is to investigate~     the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for~     their intake. The results from this project will increase our knowledge about nutritional~     value of dairy proteins, which is necessary to decide whether dairy products can be~     recommended for prevention of weight related bone loss.~   "
98081|NCT01773291|"~     The purpose of this study is to determine the therapeutic effect of acupuncture on severe~     head injury under conventional treatment. A double-blind clinical trial is conducted up to 6~     weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.~   "
98082|NCT01773278|"~     Patients with biochemically confirmed SLOS are being treated with cholesterol~     supplementation and antioxidant medication. They are carefully monitored with visits to~     clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin~     levels, blood counts and liver and kidney function. On an annual basis, the patients undergo~     a series of tests under anesthesia, including electroretinogram (ERG), brainstem audiometry~     (ABR), and ophthalmologic exam under anesthesia to follow pigmentary retinopathy.~   "
98083|NCT01773252|"~     The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow~     Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to~     the results of transesophageal echocardiography (TEE).~      RLS intracardiac shunts are associated with a number of clinically important syndromes~     including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine~     headaches (particularly with aura), desaturation with obstructive sleep apnea, and~     decompression illness. From a research perspective, the detection of shunts in subjects with~     these types of syndromes is critical in helping to define the role of RLS in these disease~     processes. From a clinical perspective, shunt detection will be increasingly important in an~     era where interventional procedures for repairing cardiac defects are available for subjects~     determined to be at risk.~      The currently accepted reference standard for detection of an intra-cardiac patent foramen~     ovale/atrial septal defect (PFO/ASD) RLS is a transesophageal echocardiography (TEE), a~     procedure that is invasive, uncomfortable, and requires conscious sedation.~      Alternative options include transthoracic echocardiography (TTE) with injection of agitated~     saline (with and without Valsalva strain), a procedure that is far less sensitive than TEE~     due to the echocardiography imaging limitations seen in many adults.~      Finally, transcranial Doppler (TCD) with injection of agitated saline (with and without~     Valsalva strain) is a newer entrant into this arena that does not require sedation or any~     invasive instrumentation.~      The Cardiox Model 100 FDS utilizes an optical sensor positioned on the surface of the~     subject's skin at the scaphoid fossa of the ear. Next, a predetermined dose of an indicator~     dye, indocyanine green (ICG), is injected at a predetermined rate into a peripheral~     antecubital vein of the subject while the subject performs a breathing maneuver called a~     Valsalva maneuver. The exhalation by the subject into a mouthpiece connected to a pressure~     transducer via a flexible tubing extension, or its equivalent (ie, performing the Valsalva~     maneuver), is an essential step for all existing RLS detection methods. The Valsalva~     maneuver by the subject creates a pressure differential between the right and left sides of~     the heart. This Valsalva maneuver results in blood flow from the right side of the heart to~     the left side of the heart through an ASD, and/or causes a PFO, if present, to open, also~     allowing blood to flow directly from the right side to the left side of the heart without~     passing through the lungs (pulmonary vasculature) for oxygenation.~      The Earpads, including their fluorescence sensor arrays (FSA), are used to measure the~     relative concentration (ie, fluorescence signal level) of ICG dye in the bloodstream as a~     function of time. If a premature inflection or peak occurs in the ICG dye concentration~     level at a time point prior to the rise and fall of the concentration associated with the~     main bolus of indicator, then a RLS is present in the heart. The amplitude of this premature~     ICG dye-dilution curve (referred to as RLS-indicator dilution curve) is used to~     subsequently quantify the magnitude of the right-to-left shunt by ratiometrically comparing~     the amplitude of this RLS indicator dilution curve to the amplitude of the main indicator~     dilution curve associated with that portion of the injected ICG dye that follows the normal~     pathway from the right side of the heart, through the lungs, and into the left side of the~     heart (referred to as normal indicator dilution curve).~   "
98084|NCT01773239|"~     The purpose of this study is to test a new computerized training program as well as to find~     out whether the computer training might help people who have schizophrenia. The~     investigators will study the effects of the computer training on how people with~     schizophrenia think about social interaction and on their social skills. At completion of~     training, TARA subjects will show improvement on measures of social cognition compared to~     their baseline performance.~   "
98085|NCT01773226|"~     This prospective single-center study will evaluate the safety and tolerability of a single~     dose of APS(TM) treated patients with OA of the knee who have failed conservative OA~     therapy. The study will also evaluate efficacy by assessing patient pain and functionality.~   "
98086|NCT01773213|"~     In this randomized, double-blind clinical trial including patients with a neurogenic lower~     urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury~     Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor~     contraction during the ice-water-test is provoked by the ice water or the rapid filling.~   "
98087|NCT01773200|"~     Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate~     of mortality and morbidity. Severe definitive neurological impairment can concern up to 30%~     of patients in relation with elevated intracranial pressure, hemorrhage recurrence and~     symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible~     reduction of cerebral artery's diameter occurring between the 4th and the 14th day after~     bleeding. Physiopathology is not well understood, but could involve endothelium, trough~     endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with~     capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial~     role in cardiovascular disease and ischemic stroke. EPC have never been studied in~     aneurysmal subarachnoid hemorrhage.~      The primary objective of this study is to compare the number of circulating endothelial~     progenitor cells between patients with a good neurological outcome (defined as a glasgow~     outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale~     = 3, 4 or 5).~      Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10,~     14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and~     hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be~     measured one year after subarachnoid hemorrhage.~   "
98088|NCT01773187|"~     The primary hypothesis of the study is that treatment with pacritinib results in a greater~     proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to Week 24~     than treatment with BAT.~   "
98089|NCT01773174|"~     Study will assess PK/PD parameters and safety and tolerability of the study medication in~     this age group~   "
98090|NCT01773161|"~     Children with cerebral palsy are at an increased risk of having their hips move partially or~     completely out of joint. This can cause pain and restrict movement at the hip, making~     sitting in a wheelchair uncomfortable and make personal care difficult. This condition may~     be treated with surgery. Surgeons use x-rays taken before and after the surgery to determine~     whether or not the surgery has been successful. However, it is also important to know~     whether the surgery has improved life from the child or the caregiver's point of view. The~     investigators will also evaluate if waiting for surgery affects the child. This information~     will be added to results from a physical exam and an evaluation of the child's x-rays for a~     more complete picture of how this surgery impacts the lives of our patients. It is predicted~     that that the health-related quality of life of children with cerebral palsy will improve~     following surgery.~   "
98091|NCT01773148|"~     The goal of this study is to assess the safety and effectiveness of the AXERA Access System~     in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary~     Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or~     6F introducer sheath.~   "
98092|NCT01773083|"~     The purpose of this international multi-center double-blind randomized placebo-controlled~     trial is to determine the effect of nebulized heparin, compared to placebo, on the number of~     ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring~     mechanical ventilation.~   "
98095|NCT01773044|"~     Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine~     and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.~      Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II,~     scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each.~     Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg~     lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control~     group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol~     30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.~   "
98096|NCT01773031|"~     A prospective intra-individual study to compare the image quality of magnetic resonance (MR)~     pancreatography at 3.0 T and 1.5 T in patients with autoimmune pancreatitis.~   "
98097|NCT01773018|"~     Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of~     c-Met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity~     against c-Met kinase and its downstream signaling targets and inhibited tumor cell growth.~     This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary~     anti-tumor activity of HMPL-504 at single doses and multiple doses.~   "
98098|NCT01773005|"~     The objective of this study is to compare the effectiveness and of perioperative use of~     Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.~   "
98099|NCT01772992|"~     Men who have sex with men (MSM) continue to be the most heavily-impacted risk group in the~     US HIV epidemic. Studies suggest that the majority of incident HIV infections among MSM are~     attributable to sex with a main male sex partner. However, HIV prevention interventions that~     target male-male couples are lacking. Because of this, Couples HIV Voluntary Counseling and~     Testing (CVCT), an intervention that has been repeatedly shown to reduce HIV transmission~     within heterosexual couples, has been adapted to US MSM couples. Additionally, novel~     evidence demonstrates that antiretroviral therapy (ART) not only reduces morbidity and~     mortality among HIV-positive persons, but also serves to reduce the risk of HIV transmission~     to a negative partner by 96%. As adherence to ART is modifiable and levels of peer support~     have been shown to increase ART adherence, this current study proposes to use CVCT combined~     with dyadic adherence counseling (CVCTPlus) to improve linkage to care, retention in care,~     ART adherence, and viral suppression among male-male couples using a cohort of 350~     serodiscordant (one HIV(+) partner, one HIV(-) partner) couples in the greater Atlanta,~     Chicago, and Boston areas. Prospective couples (175 in each arm) will be followed for two~     years. At each visit, they will receive HIV testing, and both partners will complete a study~     survey measuring social and behavioral factors that may influence adherence, such as a~     couple's coping ability and their concordance of agreements regarding outside sex partners.~     Additionally, couples in the intervention arm will receive two additional sessions of~     Partner-STEPS.~   "
98100|NCT01772979|"~     This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer~     patients with BRCA mutation and BRCAness phenotype.~      The purpose of this study is to determine the feasibility in terms of objective response~     rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in~     patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer~     patients.~   "
98101|NCT01772966|"~     Eligible subjects with chronic neck pain will be randomly allocated to one of two~     intervention groups: real vs control spinal manipulation. They will receive three~     intervention sessions.~      H1: Chronic neck pain patients treated longitudinally over a series of three encounters in~     one week by random assignment to treatment group with either of the dual delivery procedures~     (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error~     rate of self-report of group allocation at exit interview.~      H2: Patients treated by the typical-control dual procedure over a typical sequence of~     encounters (3 times in one week) will show statistically significant improvement in clinical~     outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index~     (NDI), range of motion and pressure algometry; compared to those treated by the~     control-control dual procedure.~      H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no~     significant difference in self-report of group allocation or clinical outcome measures.~      A total of 372 subjects will be recruited.~   "
98102|NCT01772953|"~     This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a~     fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in~     children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing~     allogeneic hematopoietic cell transplantation (HCT). The primary hypothesis is that HCT with~     a preparative regimen consisting of treosulfan, fludarabine and low-dose TBI will result in~     overall survival (OS) comparable to historical rates observed with conventional~     myeloablative regimens in the pediatric population. The preparative regimen will result in~     adequate incidence of neutrophil and platelet engraftment, and acceptable rates of~     graft-versus-host disease (GVHD), relapse and survival. The pharmacokinetic (PK) profile of~     treosulfan in children will be comparable to that of adults previously studied.~   "
98103|NCT01772940|"~     In resource-limited setting, concerns remain regarding the emergence of virologic failure~     and high-level drug resistance mutations (DRM) during WHO recommended first-line~     antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI)~     based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study~     hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a~     NNRTI-based regimen with a low genetic barrier to resistance.~      The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment-~     naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP)~     each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine~     (3TC). The primary end point is the incidence of therapeutic (clinical and/or~     virologic)failure by study week 24.~   "
98228|NCT01771302|"~     This randomized clinical study investigates the efficiency of plasma rich in growth factors~     (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after~     the performance of lateral sinus floor elevation.~      The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone~     formation regardless the type of bone graft.~   "
122644|NCT01450527|"~     This is a prospective observational study done to know the etiology and outcomes of Acute~     Respiratory Distress Syndrome.~   "
98104|NCT01772927|"~     Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and~     lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral~     nutrition is not possible, insufficient or contra indicated. The product has been registered~     in 18 countries in Europe via a decentralized procedure that ended 15th December 2010.~      The present study want to evaluate the use of Numeta 13% as standard medical prescription in~     the NICU of the university of Liege. It is a prospective, monocentric, non-interventional,~     non comparative, open-labeled data collection of record keeping, nutritional intakes from~     the bags, additional intakes as well as blood and urine biochemical markers currently~     evaluated in the NICU.~      The data will be collected only in VLBWI < 1500 g receiving Numeta G13% from day of birth~     (day 1) until parenteral nutrition (PN) decreases below 20% of the targeted intakes 2 days~     in a row as a quality control of the new solution in clinical practice.~      Indication for PN and daily prescription will follow the protocol in use in the NICU on~     behalf of the investigators~   "
98105|NCT01772914|"~     The purpose of this study is to determine whether copeptin levels are affected by food~     intake.~   "
98106|NCT01772901|"~     The investigators will conduct a brief educational intervention to pregnant women who have~     not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal~     influenza vaccine.~   "
98107|NCT01772888|"~     Study aims: The primary aim is to determine whether chewing efficiency, determined by a~     two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.~   "
98108|NCT01772875|"~     In patients with advanced multiple sclerosis, permanent urinary catheters are often used to~     manage the urinary incontinence and bladder emptying problems. These catheters will lead to~     urinary tract infection, blocking of the catheter etc.. Especially infections with certain~     bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and~     pseudomonas can pose a problem for the hospital infection control and for the patient.~      This study wants to evaluate the potential role of regular bladder lavage with saline, a~     solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G (~     Braun)in the decontamination of these bladders and the prevention of clinically relevant~     urinary tract infections.~   "
98109|NCT01772862|"~     The purpose of this study is to determine whether early rehabilitation intervention~     including individualized physical training and social activities with a class mate at two~     weeks intervals at the ped.onc. center will increase children with cancer's level of~     physical performance~   "
98110|NCT01772849|"~     The purpose of this study is to determine whether early rehabilitation intervention~     including educational and social activities with a class mate at two weeks intervals at the~     ped.onc. center will increase children with cancer's level of education performance.~   "
98111|NCT01772836|"~     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem~     biapenem to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
98112|NCT01772823|"~     Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of~     acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all~     participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be~     assigned at the level of the site, which include Many Men, Many Voices (3MV) and~     Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral~     intervention offered at their respective site and then be provided with open label~     emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will~     be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV~     infected during the course of the study will be discontinued from the study agent and~     followed for an additional 24 weeks after the study visit at which HIV infection is~     confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or~     the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the~     Extension Phase to more closely monitor longer-term outcome of potential concerns.~   "
98113|NCT01772810|"~     This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation~     for the treatment of chronic spinal cord injury.~   "
98114|NCT01772797|"~     The primary purpose of the study is to estimate the maximum tolerated dose of the~     combination of LDK378 and AUY922. This study will assess the safety, tolerability,~     pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of~     LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.~   "
98115|NCT01772784|"~     Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from~     cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as~     tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether~     endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators~     will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.~   "
98116|NCT01772771|"~     The main goal of this study is to perform standardized testing of tumor tissue to learn~     which genes are mutated (have changed) to provide personalized cancer therapy options to~     patients at MD Anderson. Your doctor may be able to use testing information on your tumor to~     identify clinical trials that may be most relevant to you.~      Another goal of this laboratory research study is to learn how often different genes mutate~     in patients with different cancers. Researchers will also use the information learned from~     this study to develop a database of the different kinds of mutations in cancer-related~     genes.~      Researchers also hope to better understand how mutations in cancer-related genes may affect~     a patient's response to different therapies. Researchers can use this information to select~     specific therapies for future patients that are more likely to be effective.~   "
98129|NCT01772602|"~     The purpose of this registry is to (A) better describe the incidence and prevalence of~     Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors,~     such as environmental and occupational, that may be associated with the disease; (C) better~     outline key demographic factors (such as age, race or ethnicity, gender, and family history~     of individuals who are diagnosed with the disease) associated with the disease; and (D)~     better examine the connection between ALS and other motor neuron disorders that can be~     confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.~   "
98229|NCT01771289|"~     The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent~     chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.~   "
98117|NCT01772758|"~     Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated~     premature death. Oxidative stress has been observed in patients with CF and exercise~     intolerance has been shown to predict mortality in patients with CF, regardless of how~     healthy their lungs are. A critical barrier to improving the quality of life and longevity~     in patients with CF is our lack of knowledge regarding the different reasons why patients~     with CF cannot exercise to the level of their peers. We have collected preliminary data to~     support our central hypothesis that oxidative stress contributes to the impairment in blood~     vessel function at rest and during exercise which ultimately oxygen transport and delivery~     resulting in exercise intolerance. Exercise is therapeutic medicine for patients with CF and~     this investigation represents a major breakthrough in the approach to begin understanding~     the physiological mechanisms which contribute to exercise intolerance in these patients.~   "
98118|NCT01772745|"~     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery~     with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold~     standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was~     developed with the aim of reducing the invasiveness of conventional laparoscopy. In this~     study we aimed to compare results of SILS cholecystectomy and three port conventional~     laparoscopic (TPCL) cholecystectomy prospectively~   "
98119|NCT01772732|"~     The primary objective is to assess the safety and tolerability of multiple doses of~     Simotinib Hydrochloride in NSCLC patients. The secondary objective is to determine the~     pharmacokinetic (PK) profile and explore the preliminary anti-tumor activity.~   "
98120|NCT01772719|"~     The purpose of this study is to examine the effect of simvastatin and zoledronic acid on~     M-protein and/or free light chains when added to conventional chemotherapy for the treatment~     of multiple myeloma patients.~   "
98121|NCT01772706|"~     The purpose of the study is to assess in a randomized, double blind, controlled,~     multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in~     the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV~     head and neck carcinomas.~   "
98122|NCT01772693|"~     This is a feasibility study to evaluate the safety and initial effectiveness of unilateral~     ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from~     medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial~     system compared to a Sham Vim thalamotomy procedure.~      Data will be collected to establish the basic safety of this type of treatment as the basis~     for later studies that will evaluate its full clinical efficacy. The Sham treatment data~     will be used to evaluate placebo effect from treatment.~   "
98123|NCT01772680|"~     The primary aim of this study is to measure zinc status and related proteins in patients~     with Thalassemia who have or do not have diabetes. The secondary aim will be to explore the~     effect of zinc supplementation on glucose metabolism in patients with thalassemia.~   "
98124|NCT01772667|"~     There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise~     capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there~     are no data available regarding long-term effects of this multimodal program. The aim of~     this study is to investigate the long-term impact of a rehabilitation program 3 month after~     finishing on exercise capacity and physical activity.~   "
98125|NCT01772654|"~     This study will evaluate a type of Magnetic Resonance Imaging (MRI) sequence called arterial~     spin labeling (ASL). The investigators hope that ASL can better localize areas of the brain~     (lesions) that cause epilepsy. This type of MRI does not require contrast, does not use any~     radiation, and adds on 4 minutes to the routine MRI that is done for patients with epilepsy.~      The study hypothesis is that in patients with refractory epilepsy, Arterial Spin Labeling~     (ASL) MRI will show areas of abnormality in the brain to the same degree as single-photon~     emission computerized tomography (SPECT) and positron emission tomography (PET) studies.~   "
98126|NCT01772641|"~     This study has three main aims. Aim 1: To provide initial data on the efficacy of combined~     Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing~     abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To~     explore the possibility that SGR+VN will be particularly efficacious among smokers with~     higher background levels of Cue Reactivity (CR), as assessed at the start of the study,~     using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms~     underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy,~     cue-induced cravings) of treatment effects.~   "
98127|NCT01772628|"~     The main objective of the study was to develop a novel intervention method which could~     reduce the spread of Sexually Transmitted Infections (including HIV) and unwanted~     pregnancies by improving parent-child communication using schools as gateways.~      It was done in 22 public day and mixed secondary schools in both Kampala and Wakiso~     districts. The study employed a cluster randomized controlled trial experimental design.~     Eligible schools were purposively selected and stratified into urban, peri-urban and rural.~     The schools were then matched into pairs for potential confounding variables such as~     religion and gender. In total, 11 schools were randomly allocated to the intervention and an~     equal number of schools to the comparison arms of the study.~      A questionnaire was administered to students at baseline and post-intervention. This~     questionnaire was validated in test re-test on approximately 200 S1 students from 2 schools~     that did not participate in the intervention nor the comparison arm. A parents'/guardians'~     questionnaire was also administered both at baseline then at post intervention. This~     questionnaire was also pre-tested among approximately 200 parents of S1 students who~     participated in the test re-test. The results of the pre-test were used to finalize the~     questionnaire. To increase the extent to which questions were understood, the English~     versions of questionnaires were translated into one of the widely spoken local language~     Luganda.~   "
98128|NCT01772615|"~     Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one~     week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease~     activity among ulcerative colitis patients with disease flare-ups compared to placebo~     controls.~   "
98230|NCT01771276|"~     The purpose of this study is to help find out more about how the Primary Obesity Surgery~     Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to~     weight loss. In this study, USGI Medical wants to see if stomach emptying and~     gastro-intestinal hormone levels change after a POSE procedure with an increased (as~     compared to typical) number of anchors placed.~   "
98130|NCT01772589|"~     There have been considerable efforts to control rising health care costs. One of the more~     recent developments is the practice of reprocessing single use medical devices. This~     practice has been shown to provide considerable savings for health care payers. Medical~     devices have been reprocessed in a number of different medical fields including Orthopaedic~     Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from~     Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The~     reprocessed Precision saw blades are Health Canada approved and are available at Capital~     Health.~      Beyond the benefits to the environment and cost savings, the investigators do not know if~     the reprocessed saw blades work better, work worse or the same as non reprocessed saw~     blades. This study is designed to determine if the reprocessed saw blades used during a TKA~     work as well as a new saw blade.~   "
98131|NCT01772576|"~     The objective of this study is to gather data to establish the chronic safety, performance~     and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.~   "
98132|NCT01772563|"~     The primary objective of the present study is to investigate the influence of~     co-administration of itraconazole and volasertib on the pharmacokinetic profile of~     volasertib without co-administration of itraconazole. Secondary objectives are to~     investigate safety, tolerability and preliminary therapeutic effects following intravenous~     administration of volasertib.~   "
98133|NCT01772550|"~     The purpose of this study is to compare multidetector computed tomography (CT) image quality~     following peripheral venous high pressure injection of iodinated intravenous contrast media~     between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18~     GA non-fenestrated, intravenous catheter.~      In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly~     deliver contrast agent to an individual's circulatory system. The contrast allows for~     greater differentiation of tissues in images of the area of interest, affording a better~     opportunity to visually assess the area and hence make a more accurate diagnosis.~      CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to~     provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is~     required to achieve these high flow rates; however, often the patient does not have a vein~     that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is~     designed to deliver a higher flow rate than a conventional catheter of the same gauge by~     incorporating fenestrations (small openings) near the tip of the catheter that allow fluid~     to exit the catheter in addition to that which normally exits through the main opening at~     the tip of the catheter.~   "
98134|NCT01772537|"~     Alzheimer's disease represents a growing public health problem in developed countries.~     Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid,~     neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The~     effect of anesthetic agents on changes in these proteins in humans is not well~     characterized, but in-vitro evidence suggests that anesthetic agents can accelerate~     potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis~     in cultured cells and increasing amyloid levels in mice. Human data on the effect of~     anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients~     and showed a significant increase in tau levels after exposure to anesthetics. In this study~     we propose to measure CSF and serum biomarkers in a population of patients with normal CSF~     dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. We will also~     obtain preliminary data on whether changes in CSF levels of these proteins are associated~     with postoperative delirium or cognitive change.~   "
98135|NCT01772524|"~     The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single~     dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for~     24 weeks.~   "
98136|NCT01772511|"~     The purpose of this study is to assess patients' understanding of clinical trials and to~     help researchers understand which areas of the informed consent need better explanation for~     future cancer clinical trial patients.~   "
98137|NCT01772498|"~     This study is designed to take a first step toward testing the efficacy and acceptability of~     heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress~     in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides~     clients with real time feedback about their heart rate variability (HRV) as a means of~     teaching them how to breathe in a specific, therapeutic manner.~      More specifically, this study has been designed to test several hypothesises. Each~     hypothesis is based on the prediction that, in a sample of psychologically distressed PBT~     survivors, a course of 8 HRVB sessions will demonstrate:~        -  statistically significant reductions in levels of depression~        -  statistically significant reductions in levels of anxiety~        -  statistically significant increases in resting HRV~        -  that reductions in anxiety and depression will be significantly, negatively correlated~          with increases in resting HRV~        -  that the HRVB will be viewed as an acceptable intervention by the participants~      In addition to the hypothesises stated above, the study will also investigate in a discovery~     oriented manner if the HRVB intervention will have positive impacts on the participants:~        -  levels of sleep impairment~        -  levels of pain~   "
98138|NCT01772485|"~     This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based~     internet-deliverable cognitive training program, which specifically targets the treatment of~     core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity~     Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.~   "
98139|NCT01772472|"~     This 2-arm, randomized, open-label study will evaluate the efficacy and safety of~     trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive~     breast cancer who have residual tumor present in the breast or axillary lymph nodes~     following preoperative therapy. Eligible patients will be randomized to receive either~     trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14~     cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.~   "
98253|NCT01770977|"~     Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in~     experimental models and human researches. Now, the investigators used LEDT to increase~     muscle performance of professional athletes with high performance.~   "
98287|NCT01770535|"~     The purpose of the study is to understand why there are differences between individuals in~     the way they respond to paclitaxel chemotherapy.~   "
98140|NCT01772459|"~     Research has shown that questionnaires completed on the internet have the potential to~     provide more complete and honest data with fewer errors in a more efficient manner than~     questionnaires completed using the paper and pencil format. Despite the numerous advantages~     of internet-administered questionnaires, it is important to make sure that the internet~     questionnaires will yield comparable results to the well-established paper and pencil~     versions. No one has studied internet administration of scoliosis specific questionnaires in~     adolescents with scoliosis. The investigators will test whether the internet administration~     of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The~     investigators predict that the internet-administered questionnaire will provide the same~     reliability as the paper-administered questionnaires.~   "
98141|NCT01772446|"~     Introduction: The Spanish Society of Family and Community Medicine, started the Program of~     Preventive Activities and Health Promotion, which generates periodic recommendations of~     preventive methods based on scientific evidence. In the last update it has become evident~     the need of modifications to adapt the program to modern times and focuses on improving~     accessibility and offering more flexible responses to users of the program. In this sense,~     the mobile phone technology could be useful, specifically the messaging service to remind~     patients their appointments and increase attendance rates. Main objective Compare the~     percentage of patients in the intervention group compared with the control group who~     achieved a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study~     population: Patients with diabetes with or without hypertension or lipid metabolism~     disorder, over 18 years, belonging to the Public Health System of Basque Country (primary~     care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to~     detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between~     groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of~     Papps. Control group: Routine clinical practice. Statistical analysis: The relationship~     between the intervention received and the main variable (compliance with preventive~     activities at 12 months) were analyzed using a logistic regression model.~   "
98142|NCT01772433|"~     This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back~     pain in female athletes.~   "
98143|NCT01772420|"~     This phase II trial studies how well lenalidomide and eltrombopag olamine works in treating~     patients with symptomatic anemia in low or intermediate myelodysplastic syndrome.~     Lenalidomide may stimulate the immune system in different ways and stop cancer cells from~     growing. Eltrombopag olamine may increase the number of white blood cells and platelets~     found in bone marrow or peripheral blood. Giving lenalidomide and eltrombopag olamine may be~     an effective treatment for myelodysplastic syndrome.~   "
98144|NCT01772407|"~     The primary goal of this study is to compare in the long-term costs of laparoscopic or open~     right colectomy in patients sustaining a colon cancer controling for the carcinologic~     equivalence of the two surgical strategies. The secondary goals to compare long-term~     mortality, morbidity as well as quality of life of the two groups.The present study is an~     prospective multicentric observational trial taking into account the usual surgical strategy~     of every centers~   "
98145|NCT01772394|"~     Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive~     remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised~     training cognitive therapy which addresses the difficulties in flexibility and holistic~     processing that have been incriminated in AN. CRT has been found to improve AN's~     neuropsychological functioning and short term outcome. To our knowledge, no French speaking~     country has tested its effectiveness. Moreover, the question whether it is efficient for~     both anorexic restrictive and anorexic binge-purging patients remains unanswered.~      The aim of the present study is to determine if CRT in AN adolescents and young adults has a~     favourable impact on cognitive functioning and clinical status. We will also explore whether~     the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There~     will also be an Historical Control Group of patients, sixty, who received traditional~     medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN~     study).~   "
98146|NCT01772381|"~     Introduction: Babies born at term by elective caesarean section (CS) and before onset of~     labor are more likely to develop respiratory complications than babies born vaginally. In~     developing countries resources are scarce and it is difficult to provide expensive~     treatments as neonatal care.~      Aim of the Work: To assess the effect of prophylactic dexamethasone administration before~     elective cesarean section at term in reducing neonatal respiratory complications.~      Patients and methods: 600 women were included in the study and were planned to have elective~     caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before~     delivery. 300 patients were the control group.~      The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence~     of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome~     (RDS) and the need for mechanical ventilation.~   "
98147|NCT01772368|"~     The primary objective of this study is to evaluate the dose response, efficacy, and safety~     of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with~     a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol~     Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12~     years of age and older with persistent asthma.~   "
98148|NCT01772355|"~     Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure~     that provides a sufficient amount of tissue material for standard histological and~     immunohistochemical analysis and can be an alternative or supplement to fine needle~     aspiration biopsy~   "
98149|NCT01772342|"~     Many individuals with chronic lung disease have night time symptoms that disrupt their~     sleep. The purpose of this study is to determine the effects of an air purifying device~     (PureNight, Halo Innovations, Minneapolis, MN) on sleep disruptions measured by a sleep~     watch (actigraph) and individual perception of sleep quality.~   "
98254|NCT01770964|"~     The difference between active treatment and placebo in a clinical trial of an analgesic~     appears to depend on a variety of factors other than the actual efficacy of the drug itself,~     including various aspects of study design and conduct. One potential such factor is how~     information about the study is presented to research staff and patients. The purpose of this~     study is to examine the impact of different presentations of information on the difference~     between pregabalin and placebo observed in a clinical trial in patients with painful~     diabetic neuropathy.~   "
98150|NCT01772329|"~     The investigators propose a randomized controlled trial to evaluate the effects of treatment~     intended to reduce pain catastrophizing among patients reporting high pain catastrophizing~     prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an~     effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance~     physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor~     of PPP following total knee replacement is highly innovative and have potentially high~     impact for public health. Cognitive therapy is a well-tolerated modality among chronic pain~     patients with few if any side effects. Cognitive therapy (CT) represents an inexpensive~     method that could greatly reduce suffering and costly post-surgical pain management for high~     risk TKR patients.~   "
98151|NCT01772316|"~     This multicenter, open-label, single arm, long-term extension study will evaluate the safety~     and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe~     rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core~     study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly~     (for participants entering from WA22762) or every two weeks (for participants entering from~     NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.~   "
98152|NCT01772303|"~     This multicenter, prospective, open-label, outpatient study will assess the safety and~     efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100~     subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers,~     diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis~     and trauma wounds) of at least 4 weeks documentation.~   "
98153|NCT01772290|"~     This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of~     coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or~     an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of~     non-childbearing potential. Subjects will be randomized to receive multiple oral doses of~     vismodegib, alone or in combination with multiple oral doses of either rabeprazole,~     itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.~   "
98154|NCT01772277|"~     To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC)~     at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).~   "
98155|NCT01772264|"~     The most notable tolerability finding from these multiple dosing studies has been the~     occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this~     finding, the current four week study is designed to examine whether a slow titration regimen~     up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.~   "
98156|NCT01772251|"~     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism~     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current~     methods of insulin therapy for diabetic patients are multiple daily injection therapy and~     continuous subcutaneous insulin infusion with an external pump. This rout of administration~     may lead to hyperinsulinemia as insulin is administered in a non physiological way,~     targeting mainly extra hepatic tissues (muscle, fat).~      A method of providing insulin without the need for injections has been a goal in drug~     delivery.~      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on~     biochemistry and quantum theory of biochemical reactions. The carrier enables the absorption~     of proteins from the gastrointestinal tract in their full structure. Oshadi has also~     developed the Oshadi Icp - insulin, proinsulin and C-peptide in Oshadi carrier,~     administrated orally. This study was design in order to evaluate the safety and feasibility~     of multiple administration of Oshadi Icp~   "
98157|NCT01772238|"~     The objective of this study was to confirm if two formulations of amoxicillin and clavulanic~     acid (suspension) are bioequivalent.~      Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo~     Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg~     Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 35 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
98158|NCT01772225|"~     The aim of this observational study is to identify and quantify the humanistic and economic~     burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA~     NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data~     collection will be conducted through patient medical record abstraction and patient survey.~   "
98159|NCT01772212|"~     The objective of this study was to confirm if two formulations of terbinafine (tablets) are~     bioequivalent.~      Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product~     Lamisil® 250 mg (Novartis). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 30 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
98179|NCT01771952|"~     The purpose of this study is to determine how safe a knee injection called Synvisc-One® is~     in patients with a condition called chondromalacia patella and how well in works in treating~     the condition.~      Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called~     Runner's Knee, this condition often affects young, otherwise healthy individuals.~      Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of~     the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage~     normally glides effortlessly across the knee during bending of the joint. In some~     individuals, the cartilage on the undersurface of the knee cap becomes irritated and soft,~     resulting in pain. Potential treatments for this condition include rest, injections (numbing~     or anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening~     exercises which may help reduce pain.~      Other Treatments are being evaluated. This study is about Synvisc-One® an experimental~     device that has been approved by the Food and Drug Administration (FDA) for the treatment of~     pain in osteoarthritis (OA) of the knee in patients who have failed to respond to treatments~     that do not involve drugs or surgery and simple pain medication such as acetaminophen.~     Synvisc-One® is a gel-like substance that, when injected into a joint, acts to lubricate and~     cushion the joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found~     normally in joint fluid.~      Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia~     patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far,~     this drug/device has been given to over 10,000 people who have knee pain (due to~     osteoarthritis) and has been proven safe and effective in patients with moderate to severe~     pain due to knee joint osteoarthritis.~   "
98160|NCT01772199|"~     This is a randomized, parallel group, placebo-controlled study designed to assess whether~     GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple~     Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex~     (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects~     will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be~     managed with their current standard of care therapy (Copaxone or Avonex). The total~     treatment period is 48 weeks, including a standard 4 week titration period and 44 week~     maintenance treatment period (which could be adapted to a 5-week titration and 43 week~     maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up~     to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week).~     Subjects will be titrated to the maximum tolerated dose with the objective of titrating to~     the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of~     tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration~     following the end of treatment at Week 48 or early withdrawal, as appropriate.~   "
98161|NCT01772186|"~     Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms~     in people with Parkinson's disease (PD), and closely associates with postural instability~     and fall. Previous studies had shown that somatosensory stimulation could induce weight~     shift, and this is probably helpful for gait reinitiation. Therefore, the investogators~     propose a two-year project to develop a wearable device, the somatosensory stimulation~     system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG~     episodes detected. And the investigators test the effects of this SSS device on FOG, fall,~     and walking function.~      Methods: The first-year study is to build and validate this wearable SSS device. The~     customized device has sensor part and stimulator part; the former is an inertial sensor~     module to detect FOG episodes, and the latter is a microvibrator-embedded insole to~     facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are~     recruited and conduct FOG-provoking tasks during their medication OFF or late On state~     in a laboratory setting. The investigators test if the SSS device could facilitate lateral~     weight shift and help gait reinitiation, as well as the reliability. The second-year study~     is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its~     effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG,~     and randomly assign them into the experimental and control groups. Both groups wear the SSS~     device during the daytime for ten weeks, and the stimulator part is turned on during the~     first six weeks (intervention phase) only in the experimental group. The stimulator part is~     then kept off during the last four weeks (follow-up phase) in both groups. The effect of the~     SSS device is evaluated by the outcomes including FOG severity, fall and walking function,~     which are measured prior/after the intervention phase and after the follow-up phase.~      Clinical relevance: This project tempts to combine real-time gait analysis with~     somatosensory-induced postural readjustment, and using this novel approach to improve FOG~     and fall in people with PD. The results of this projects might also provide an objective,~     long-term assessment tool to measure the FOG phenomenon for clinical and research fields.~   "
98162|NCT01772173|"~     Diabetic complications are an important source of blindness and mortality among Veterans.~     Their occurrence is unpredictable because of the highly variable effect of factors such as~     weight, diet and exercise. Improved prediction of diabetes complications has the potential~     to improve the care for Veterans with diabetes, especially if this can be done without any~     extra effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are~     required to undergo annual retinal photography to screen for current diabetic retinopathy.~     The investigators have recently developed an automated, precise, fast, novel tool for~     measuring retinal vessels in these images. Manual measurement of retinal vessels has shown~     that these can predict future -not current- development of hypertension and also diabetic~     retinopathy. If the investigators can confirm that their tool can flag those Veterans at~     increased risk for developing these diabetes complications, this will allow earlier~     intervention and prevention. Because the tool only uses the images that are being taken~     anyway, there is no extra effort for either the Veteran or VA staff.~   "
98163|NCT01772160|"~     The purpose of this study is to collect data on the incidence, complications, economic~     burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.~   "
98164|NCT01772147|"~     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium~     bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and~     umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily~     with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function,~     COPD-related health status assessments and safety in COPD subjects.~   "
98165|NCT01772134|"~     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium~     bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily,~     umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg)~     twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on~     lung function, COPD-related health status assessments and safety in COPD subjects.~   "
98166|NCT01772121|"~     This study will define the substantial disease burden associated with viral hepatitis in~     India, and provide a foundation to understand the host and viral determinants of disease~     pathogenesis that may ultimately impact treatment decisions and outcome~   "
98167|NCT01772108|"~     This trial is a randomized study of the MitraClip device in heart failure patients with~     clinically significant functional mitral regurgitation. A hierarchical composite of~     all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at~     a lower rate with the use of the MitraClip device in addition to optimal standard medical~     therapy compared to optimal standard of care therapy alone.~   "
98180|NCT01771939|"~     The purpose of the study is to evaluate the difference in Early Treatment Diabetic~     Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2~     groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent~     phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM)~     peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5~     years.~   "
98181|NCT01771926|"~     The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle~     intervention in overweight and obese glucose intolerant adults. We will evaluate the effects~     of the consumption of potatoes (high or low resistant starch) vs. commonly consumed~     carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption~     alters markers of lipid metabolism and inflammation in the context of a lifestyle~     intervention program.~   "
98182|NCT01771913|"~     The purpose of this study is to investigate if there is a relationship between the take of~     fat grafts with and without ADSCs and the presence of specific surface markers on the cells~     of the stromal vascular fraction.~   "
98255|NCT01770951|"~     The objective of this retrospective trial is to assess safety and efficacy of eculizumab in~     aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.~   "
98168|NCT01772095|"~     In 1906, Dr. Alois Alzheimer first described the disease that later took his name. Today,~     100 years later, 24 million people worldwide suffer from Alzheimer's disease or other~     dementias.~      The term 'dementia' is clinical and is used to describe brain disorders that cause decline~     in mental functions, memory first and then speech, judging and overall behavior. Alzheimer's~     disease is by far the most common form of dementia, followed by vascular dementia, dementia~     with Lewy, the frontotemporal dementias etc.~      In Greece there are 141,000 patients with dementia. With increasing life expectancy, the~     figures are expected to increase dramatically in the future.~      Alzheimer's disease is the most common form of dementia, as well as 50-60% of patients with~     dementia suffer from this disease. The second most common type of dementia is vascular, ie~     that associated with cerebrovascular disease and is the 15-30% of all dementia cases and is~     most common between the ages of 60-70 years and is more common in men than women. It is~     estimated that 5% to 8% of people over 65 suffer from dementia, while in industrialized~     countries ranges at the following levels :15-25% over 85 and 32% over 90 years.~      Dementia is characterized by a slow onset and progressive course. The syndrome includes~     disorders in general intelligence, learning and memory, problem solving, perception,~     judgment, executive function, language and synergy of movement, but without impairment of~     consciousness.~      Alzheimer's disease is a neurodegenerative disorder with distinct clinical and~     histopathological features, although with variations from person to person.~      In its early stages it is sometimes difficult to diagnose cognitive impairment from normal~     aging of the brain. With the passage of time, the continuous decline in recent memory,~     fluency, ability for spatial orientation ultimately restricts the autonomy regarding basic~     activities of daily life such as managing finances. The anxiety and depression complicate~     diagnosis in early stages, but gradually decline with loss of sensitivity. Intermediate~     stages of the disease require increasingly supervision in daily self-care activities, such~     as personal hygiene and clothing. In the advanced stages are usually essential nursing care~     in institutional context.~      The severity of symptoms of the disease varies and is determined by premorbid factors such~     as education, gender, cultural background. Epidemiological studies have shown as protective~     factors against the onset of dementia, higher education, taking estrogen and~     anti-inflammatory drugs. On the other hand, age, family history of dementia, head injury,~     hypertension and Down syndrome are risk factors for developing the disease. Finally, some~     genetic factors appear to be protective, and other pressures to the disease.~   "
98169|NCT01772082|"~     Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated~     website to promote walking and physical activity. Primary outcome is 6-minute walk test~     distance. Intervention lasts 3 months.~   "
98170|NCT01772069|"~     Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though~     rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia~     can bring out the disability in daily life, the majority of previous reports only~     ascertained no significant association between the presence of fibromyalgia and the severity~     of SLE.~      It is necessary to make unremitting effort to reduce the mortality and life-threatening~     disease flare-up due to SLE disease itself. Additionally, we think that physicians need to~     pay more attention to improve health-related quality of life (HRQoL) in the patients with~     SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease~     duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the~     clinically important and constructive theme to investigate that which is the most important~     factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.~      The objective of this study is to evaluate the degree of contribution of fibromyalgia for~     reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with~     SLE.~   "
98171|NCT01772056|"~     The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term~     treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of~     AD, but not its efficacy and security to reduce or prevent relapses.~      Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate~     (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of~     an acute flare of AD with FP cream.~   "
98172|NCT01772043|"~     We will utilize the Cooperative International Neuromuscular Research Group (CINRG) network~     to collect and store tissue and blood from patients with Duchenne muscular dystrophy (DMD)~     with specific genetic mutations within the dystrophin gene that could be treated by~     antisense oligonucleotide (AO) drugs.~   "
98173|NCT01772030|"~     The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation~     after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary~     vein reconnection, specific sites of reconnection will be evaluated with left atrial~     intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated~     head-to-head with our current method of ICE-guided recordings from a conventional mapping~     catheter with high output pulmonary venous pacing.~   "
98174|NCT01772017|"~     To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating~     subjects with Obstructive Sleep Apnea (OSA) and snoring.~   "
98175|NCT01772004|"~     This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting~     programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in~     subjects with selected tumor indications. New recruitment is open for all active cohorts.~      Active cohorts: Escalation revised dosing regimen cohort.~      Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum),~     metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary),~     mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and~     ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell~     carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC),~     castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial~     carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal~     cell carcinoma (RCC, first line) and escalation phase .~   "
98176|NCT01771991|"~     The purpose of this study is to determine if topical superoxide dismutase is an effective~     treatment of radiation related neck fibrosis, and to determine the quality of life impact~     from radiation related fibrosis in the head and neck cancer patients at Sanford Health.~   "
98177|NCT01771978|"~     Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft~     (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary~     artery clamping. The aim of this study was to compare the preventive effects of diltiazem~     and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and~     oxidative stress during off-pump CABG surgery.~   "
98178|NCT01771965|"~     The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral~     (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans~     who call the Crisis Line but are resistant to behavioral health services.~   "
98256|NCT01770938|"~     Muscle performance is largely influenced by modulations in gene expressions of muscle~     tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle~     performance in experimental models and human researches. Thereby, the investigators examined~     modulations in gene expression of muscle tissue as well as biochemical, biomechanic and~     histologic adaptations influenced by exercise associated to LEDT.~   "
98183|NCT01771900|"~     The purpose of this feasibility study was to obtain pilot data, as the basis for a future,~     larger investigation, testing the impact of an innovative training camp intervention called~     HEART CAMP (Heart failure Exercise And Resistance Training CAMP) to teach HF patients how to~     exercise and self-manage exercise behavior over time. The study assessed the feasibility and~     adequacy of the intervention, the data collection plan, and the reliability and sensitivity~     of the outcome measures. The 6-month intervention was based on a training camp model to~     teach HF patients how to exercise in a fun, group-oriented atmosphere. Subjects interacted~     and exercised in small groups with an exercise physiologist and nurse to guide activities.~     The dosage of the intervention (frequency and amount of direct guidance from the exercise~     physiologist and nurse) decreased over the 6 months in order to increase subject's~     independence and promote long-term adherence to exercise. The intervention incorporated use~     of computerized data files to monitor exercise behavior, compare exercise performance to~     individualized goals and provide feedback as strategies to foster adherence and~     self-management of exercise behavior.~   "
98184|NCT01771887|"~     Diabetes mellitus is a disease of great frequency and is a major public health problem. In~     Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year~     2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications~     of this disease and the lack of studies at this level, it is appropriate to conduct a study~     that aims to evaluate the effects an education program for people with type 2 diabetes on~     their sense of self-efficacy and their ability to self-manage their disease to make them the~     most optimal therapeutic adherence possible. The design of this study is experimental type~     before / after randomization by diabetic patients. Education program delivered to the~     experimental group is the Accu-Chek Education Program of Roche. Membership will be~     assessed using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes~     Self-Care Activities Measure), which measures self-care behaviors. Self-efficacy is measured~     using the Diabetes Management Self-Efficacy Scale. And this before the intervention and 3~     months later. The sample will be 240 diabetic patients T2. Recruitment will be in outpatient~     diabetology a Hospital located in Beirut. Statistical analyzes used for descriptive~     variables are measures of central tendency, dispersion and frequency distribution. T-test~     and chi-square will be used to compare the socio-demographic characteristics of the 2~     groups, experimental and control. To test hypotheses and determine the difference in the~     results of the dependent variables of the 2 groups, analysis of variance and covariance are~     used. The data will be processed using SPSS version 14.0.~   "
98185|NCT01771874|"~     The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a~     dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and~     pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The study will~     provide further understanding of the dopaminergic regulation of mood.~   "
98186|NCT01771861|"~     The aim of the study is to establish the predictive properties of our trauma team activation~     protocol, and its individual criteria, and if possible to suggest changes that reduce over-~     and undertriage.~      The study will also give an overview of the frequency and type of emergency procedures at a~     university hospital trauma center, which can contribute to optimal resource use and indicate~     which type of surgical skills are necessary in our trauma emergency procedures.~   "
98187|NCT01771848|"~     The study is designed to establish the best dose to safely infect healthy individuals with~     Plasmodium falciparum sporozoites (PfSPZ) by injection.~      The goal of this study is to achieve infections in human volunteers with infection rates of~     100% and pre-patent periods of less than 12 days.~   "
98188|NCT01771835|"~     Measurement of the circulation in patients with diabetes mellitus and establish a link~     between retinal venous pressure (RVP) and endothelin (ET-1)levels.~   "
98189|NCT01771822|"~     This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to~     cause irritation after repeated topical application to the healthy skin of human subjects~     under controlled conditions.~   "
98190|NCT01771809|"~     Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will~     receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of~     the drug.~   "
98191|NCT01771796|"~     The purpose of this study is to determine the potential benefits resulting from a specific~     training on exercise tolerance and muscle function at the medium and long-time, as well as~     study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung~     cancer following resection surgery.~   "
98192|NCT01771783|"~     The primary objective is the characterization of the RAS peptide profiles after single and~     repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin~     receptor blocker in healthy volunteers.~      Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic~     profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood~     pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone~     concentrations. Fluid and sodium intake will be monitored using sodium concentration and~     total volume in 24h urine.~   "
98193|NCT01771770|"~     The hypothesis is that the pressure in the retinal veins increases from chronic lack of~     oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this~     hypothesis should be verified. At the same time the adaptation capacity of the blood~     circulation should be analyzed, and a relationship to mountain sickness should be found.~   "
98194|NCT01771757|"~     The hypothesis is that the pressure in the retinal veins increases under a short-term lack~     of oxygen and leads to a decreased blood circulation. On the basis of measurements in the~     hypobaric chamber this hypothesis should be verified.~   "
98195|NCT01771744|"~     This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass~     (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional~     laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric~     banding.~   "
98219|NCT01771419|"~     Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be~     associated with fewer complications and post-ERCP (Endoscopic retrograde~     cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access~     with cannulotome (CT-25 Cook Medical) with contrast injection even if results are~     conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop~     in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.~   "
98196|NCT01771731|"~     Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic~     pain in patients with sickle cell disease (SCD). As these patients will all be on chronic~     opioid analgesics, the investigators will also assess the possible synergistic affect~     between inhaled cannabis and opioids. The investigators will also assess the clinical safety~     of the concomitant use of cannabinoids and these opioids in patients with SCD by monitoring~     the short-term side effects associated with combined therapy. Finally, the investigators~     will evaluate the short-term effects of inhaled cannabis on markers of inflammation and~     disease progression in patients with SCD.~      Hypotheses are as follows:~        1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD.~        2. Inhaled cannabis will significantly alter the short-term side effects experienced by~          patients who take opioids for SCD.~        3. Inhaled cannabis will significantly alter markers of inflammation and disease~          progression in patients with SCD compared to placebo.~   "
98197|NCT01771718|"~     The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image~     in-vivo pigmented and non-pigmented human skin lesions for characterization of their~     morphologic and functional features. .~   "
98198|NCT01771705|"~     The purpose of this study is to compare two different ways of monitoring the immune system~     to determine how to manage the doses of anti-rejection medications.~   "
98199|NCT01771692|"~     Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a~     lot of research into the factors that can affect the speed of alignment of teeth but there~     has been very little research on how different techniques of wire attachment to the brace~     (ligation) can affect this.~      The randomised clinical trial of 100 patients aims to compare the speed of alignment of the~     lower (mandibular) front teeth (incisors) using two different techniques over a period of 12~     weeks. Both techniques use the conventional small elastic rings (modules) that are placed~     over each metal square (bracket) but they will be tied in a different configuration for each~     group. We will also observe any differences in the distances between the corresponding teeth~     either side of the lower jaw for each group and the bracket failure rates.~   "
98200|NCT01771679|"~     The purpose of this study is to determine whether a one-time injection of allogeneic~     mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the~     face.~   "
98201|NCT01771666|"~     To determine concordance between isosulfan blue (ISB) and indocyanine green (IC-GREEN™) in~     the identification of lymphatics and arm-draining nodes during nodal staging procedures in~     breast cancer.~   "
98202|NCT01771653|"~     The purpose of this observational study is to compare two approved treatment regimen(s)~     containing boceprevir and telaprevir, as part of standard of care for the treatment of~     hepatitis C.~   "
98203|NCT01771640|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival~     by several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
98204|NCT01771627|"~     This pilot clinical trial studies varenicline or nicotine patch in promoting smoking~     cessation among current smokers. Varenicline or nicotine patch may help people stop smoking~   "
98205|NCT01771614|"~     The effects of exercise on glucotoxicity will be determined in healthy subjects.~     Experimental hyperglycemia will be induced via a constant- or fluctuating-rate glucose~     infusion to establish different patterns of glycemic variability. The outcomes of~     hyperglycemia will be determined by measuring pancreatic endocrine function, insulin~     sensitivity, endothelial function, and oxidative stress.~   "
98206|NCT01771601|"~     Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The~     commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs.~     1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously~     to test for their relative sensitivity for low oxygen levels just after birth on term~     infants born by elective caesarean section. Reproducibility will be examined by replacements~     of the sensors six times the next day when the infant is stable and quiet. The Adult~     Somasensor (INVOS) will be used together with the OxyPrem sensor.~   "
98207|NCT01771588|"~     It it is hypothesized that the growth of preterm infants receiving a new human milk~     fortifier will be equal or superior to the growth of preterm infants receiving a currently~     marketed human milk fortifier with a lower protein content.~   "
98208|NCT01771575|"~     Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for~     Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World~     Health Organization recognizes TBI as one of the most significant health issues in~     developing countries. In the military, mild traumatic brain injury (mTBI) is one of the most~     frequent sequela of modern war. Dizziness and balance disorders are the most frequent~     sequela of mTBI and account for a significant degree of mTBI morbidity. At the current time,~     the best treatment modality for dizziness secondary to mTBI is vestibular rehabilitation~     (VR). While VR is effective, the therapy is time consuming, not universally successful, and~     results in incomplete recovery by many patients. Work needs to be done in an attempt to~     improve therapy outcomes. This project will study the use of neuromodulation (through~     stimulation of the tongue) as an adjuvant to improve the effectiveness of VR and reduce the~     time involved in VR. Given past work with variants on this minimal medical impact appliance,~     using the PoNS™ device to augment therapy may result in a significant improvement in VR~     outcomes. Given the enormous public health and military burden of mTBI, and given that~     dizziness is a major component often responsible for significant morbidity, this project has~     significant military and civilian impact and can be beneficial to those who suffer mTBI~     worldwide.~   "
98220|NCT01771406|"~     The aim of this study is to examine how effective CPAP treatment and treatment with~     nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in~     patients suffering from obstructive sleep apnea and hypertension.~   "
98257|NCT01770925|"~     non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to~     compare between capap and n-bipap~   "
98209|NCT01771562|"~     The advent of highly active antiretroviral treatment has resulted in the survival into~     adolescence of an increasing proportion of infants and children with perinatal HIV infection~     in Senegal. However, the transformation of HIV into a chronic disease needing lifelong~     antiretroviral treatment (ART) raises new challenges, among others related to a disturbance~     of glucose metabolism, lipid abnormalities, in addition to the potential effects on~     children's growth and puberty. Little is known on nutritional and metabolic changes in~     HIV-infected children on ART in Africa, while implementation of the latest WHO~     recommendations should eventually lead to an increase in the number of children on ART in~     this region. Moreover, bio-clinical evolution of untreated children is poorly documented in~     the African context. It therefore urgently needed to institute a cohort study to evaluate,~     in the long term, the impact of HIV infection and/or ART on nutritional and metabolic~     disorders and to characterize the risk factors of their occurrence in children and~     adolescents infected as they move through adolescent into adulthood.~   "
98210|NCT01771549|"~     This pilot study involves very frequent monitoring of breast cancer patient blood levels of~     hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of~     chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both~     biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are~     frequently elevated after experimental chemotherapy in animal models. Their behavior in~     humans has been inconsistent, with occasional elevations seen, usually within 30 days of~     therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced.~     A majority of patients greater than age 50 have elevations above the detection limit,~     compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have~     elevations above the detection limit. Moreover, augmented release of high sensitivity~     troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in~     patients with and without coronary artery disease. This improved sensitivity suggests the~     potential for detection and monitoring of cardiac damage after cancer chemotherapy. We~     hypothesized that this new generation of troponin assay would be associated with kinetic~     behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also~     with trastuzumab.~   "
98211|NCT01771536|"~     Despite several large clinical trials clearly establishing that coronary revascularization~     (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent~     myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable~     angina continue to believe that PCI is performed to improve these outcomes. Additionally,~     recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus~     there is a compelling need to share with patients the risks and benefits of PCI prior to~     treatment to reach an informed decision.~      This study is designed to answer the question of whether a decision aid can improve patient~     knowledge, decisional conflict and patient satisfaction with decision-making compared to~     usual care for the treatment of stable angina.~   "
98212|NCT01771523|"~     Background : The use of suction drains in thyroid surgery is common practice in order to~     avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that~     might compromise the patient's airway. The aim of this study to determine the effects of~     routine drainage compared to no drainage in thyroidectomy patients.~      Study Design : Total of 400 patients who undergoing total thyroidectomy or lobectomy for~     thyroidal disorders will be randomly allocated to be drained or not. Postoperative~     ultrasonographic (USG) neck examination will be performed for all patients on postoperative~     24th hour by the same ultrasonologist each time. Postoperative pain, complications and~     hospital stay will be recorded. The statistical analysis will be performed and p<0,05 will~     be accepted as an important statistical value (SPSS 16.0 for Windows).~   "
98213|NCT01771497|"~     The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment~     of breast cancer will allow for accurate tumor localization and tumor volume measurement,~     leading to improved surgical and radiation therapy outcomes.~   "
98214|NCT01771484|"~     The investigators will test to determine if an external Automated Abdominal Binder~     (non-commercial product) during high sodium diet improves orthostatic tolerance, compared to~     wearing the binder during a low sodium diet session.~   "
98215|NCT01771471|"~     This is a clinical study to collect safety and preliminary efficiency information on the use~     of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to~     treat low back pain.~   "
98216|NCT01771458|"~     SHIVA is a proof of concept randomized phase II trial which compares two treatment~     strategies for patients with refractory cancer.~      From a tumor biopsy, a molecular profile of the disease is established (mutations,~     amplifications, hormone receptor status). If a molecular abnormality is identified for which~     an approved targeted agent is available, patients are randomized randomized between two~     arms:~        -  Targeted therapy based on the molecular profile~        -  Conventional therapy based on investigator's choice.~      A cross-over is proposed at disease progression.~   "
98217|NCT01771445|"~     Aim: Evaluate the regulation of muscle derived Interleukin-6 (IL-6)during exercise and in~     particular whether it is regulated by the Interleukin-1 (IL-1) system.~      Rationale: It has been shown that IL-1 antagonism improves glycemia and insulin secretion in~     patients with type 2 Diabetes. However, IL-1 antagonism also decreases IL-6 levels. The~     effect if IL-6 on the glucose metabolism has been unclear in the past and subject to intense~     debate, with recent evidence indicating a beneficial role in regulating glucose metabolism.~     However little is known about regulation of muscle-induced IL-6 produced during exercise. It~     is therefore our aim to investigate whether exercise induced increases in IL-6 are dependent~     on the IL-1 system. If IL-1 antagonism does decrease IL-6 and along with it, the beneficial~     potential of IL-6, this may require additional medication like IL-6 substitution or~     dipeptidyl peptidase-IV (DPP-IV)antagonists.~      In addition, the investigators will assess the effect of IL-1 antagonism on insulin and~     Glucagon like peptide-1 (GLP-1) secretion as well as muscle soreness,fatigue and vascular~     function in response to an acute exercise bout.~   "
98218|NCT01771432|"~     Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney~     transplant recipients could be useful to prevent pyelonephritis in these patients.~   "
98270|NCT01770756|"~     The purpose of this study is to compare the effectiveness of two forms of self-care training~     on the overall health of adults with hypertension.~   "
124353|NCT01427972|"~     The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males~     and females with chronic kidney disease.~   "
98221|NCT01771393|"~     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.~     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for~     an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could~     detect and characterize chondral lesions the cartilage similarly to a multidetector CT~     (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or~     knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to~     detect cartilage lesions. Secondary endpoints will concern the depiction of the joint~     lesions, quality of the images, tolerability of the exams and inter- intra-operator~     reproducibility. After arthrography, patients will have a MDCT considered as the reference~     exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two~     trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis~     of cartilage lesion type between the two techniques will be evaluated by a kappa~     coefficient. The evaluation of diagnostic performance will be achieved by studying the~     sensitivity, specificity, negative predictive value and positive predictive value, and its~     likelihood ratio. Kappa test will be performed to evaluate the consistency of the depiction~     of the lesions. A Student t test will be performed for paired data if distributions are~     normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful,~     not painful) will be calculated for each technique and will be compared using the Chi2 test~     (or Fisher's exact test if the chi can not apply).~   "
98222|NCT01771380|"~     In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein~     (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free~     fraction that is biologically active. Polymorphisms in DBP are related to the serum level of~     25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the~     total serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we~     will calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and~     also measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we~     will relate total serum 25(OH)D as well as the free and biologically active (free-~     albumin-bound) 25(OH)D to the well established vitamin D effect marker serum parathyroid~     hormone as well as to the RNA expression in peripheral blood to evaluate the biological~     importance of the free versus the total fraction of 25(OH)D. We will invite 300 subjects~     from an ongoing vitamin D supplementation study to participate in the study which will be~     one visit only and include collection of blood samples.~   "
98223|NCT01771367|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigen-specific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5-year 30 million Euro project~     funded by the Innovative Medicines Initiative. The project involves a series of clinical~     studies using licensed vaccines as benchmarks to generate clinical data on inflammation and~     identify biomarkers that can be used to predict acceptable reactogenicity. The target is to~     identify biomarkers that can predict the occurrence of beneficial and detrimental effects in~     response to a vaccine. Such biomarkers could be used in future vaccine development programs~     to optimise selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalised use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     population. Forty-eight subjects will be randomised into three groups to receive: a) Fluad~     (n=20), b) Agrippal (n=20), c) saline placebo (n=8). Following a screening visit,~     participants will undergo a seven-day residential visit which will include immunisation and~     intensive monitoring of physiological (e.g. heart rate, oral temperature, blood pressure)~     metabolic and immune (innate and adaptive) parameters. This visit will be followed up by~     four outpatient visits with further monitoring and blood samples.~   "
98224|NCT01771354|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the~     Innovative Medicine Initiative. The project involves a series of clinical studies using~     licensed vaccines as benchmarks to generate clinical data on inflammation and identify~     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify~     biomarkers that can predict the occurrence of beneficial and detrimental effects in response~     to a vaccine. Such biomarkers could be used in future vaccine development programs to~     optimize selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalized use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     target population. Twenty four subjects will be randomised into two groups to receive: A)~     Engerix B vaccine (n = 20), B) Saline placebo (n = 4). Following a screening visit,~     participants will undergo two immunisations at month 0 and month 6. Each immunisation will~     occur during a seven day residential visit which will include immunization and intensive~     monitoring of physiological (e.g. heart rate, oral temperature, blood pressure) metabolic~     and immune (innate and adaptive) parameters. Both residential visits will be followed up by~     four outpatient visits with further monitoring and blood samples.~   "
98225|NCT01771341|"~     Neurally adjusted ventilatory support improved synchronization in the medical patient.~     However no data are available in the postoperative patient.~      This way the investigators designed a prospective randomized cross over trial to evaluate~     this issue in the abdominal post-operative patient.~   "
98226|NCT01771328|"~     The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH)~     renders the cortisol levels unphysiological, which may cause symptoms and long-term~     complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous~     hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This~     method was recently applied to treat a patient through a critical phase of puberty. This is~     a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective~     is to determine the effects of CSHI on metabolic parameters (androstenedione and~     17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH),~     cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary~     objectives are to determine effects on clinical status, body weight, blood pressure and~     other metabolic parameters, as well as on subjective health status (AddiQoL, SF36).~   "
98227|NCT01771315|"~     The aim of this study is to determine the effect of nurse led follow-up following total knee~     arthroplasty in regard to physical function, health related quality of life and~     self-efficacy.~   "
98271|NCT01770743|"~     The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine.~     The vaccine schedule and dose will also be assessed.~   "
130333|NCT01349465|"~     The purpose of this study is to investigate TMC435 for the treatment of chronic hepatitis C~     virus (HCV) infection.~   "
98231|NCT01771263|"~     In closed-loop controlled anesthesia, feedback from a measure of the clinical effect is used~     to continuously adjust drug infusion rates. Anesthetic drugs are delivered at a variable~     rate that is personalized to the individual patient. The aim is to provide greater~     hemodynamic and respiratory stability, more stable depth of anesthesia, the ability to~     predict recovery and to administer a lower total dose of drug. Previous work in closed-loop~     control of intravenous anesthesia has focused on the titration of propofol in response to a~     depth of hypnosis (DOH) measure derived from the electroencephalogram (EEG).~      The purpose of this pilot study is to evaluate iControl-RP, a system, which performs~     controlled delivery of both remifentanil and propofol infusions. iControl-RP allows either~     drug to be operated in any of 3 modes: closed-loop control based on feedback from an EEG~     measure supplied by NeuroSENSE (1); target-controlled infusion (TCI), based on~     previously-described pharmacokinetic (PK) and pharmacodynamic (PD) models; and conventional~     manual infusion, which require a weight-based dose setting.~      A pilot two-phase study will be undertaken in a group of adult patients under the direct and~     immediate supervision of an experienced anesthesiologist. In Phase 1 (involving 50 study~     subjects), propofol will be administered in closed-loop mode and a remifentanil infusion~     will be administered based on a TCI. The data collected in this phase will be used to tune~     the controller parameters, which are initially based on previously published PKPD data. The~     controller performance will then be evaluated in phase 2 (involving 100 study subjects), in~     which both propofol and remifentanil will be administered in closed loop mode. In both~     phases, cases will be selected from those receiving propofol and remifentanil as anesthetic~     agents for routine surgical procedures.~      The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia~     based on EEG feedback is clinically feasible. This pilot study will help us take a~     significant step towards a controlled trial in which the clinical benefit of this method of~     closed-loop control of anesthesia can be assessed.~   "
98232|NCT01771250|"~     This study has two parts. Each participant will receive a daily injection of LY2605541~     during one treatment period and a daily injection of insulin glargine during the other~     treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to~     look at how the body uses or stores fats while taking each study drug.~   "
98233|NCT01771237|"~     This exploratory study aims to design and test an HIV prevention intervention for young men~     who have sex with men (MSM) between the ages of 16-20 as this group comprises the US~     adolescent population most at-risk for HIV infection through sexual contact. To help develop~     the content and format of our intervention we will first conduct in-depth interviews with~     twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact~     between ages 16-20 (i.e., the target age of our intended intervention). We will then design~     a group-based primary intervention for young MSM between ages 16-20, relying on the~     information we gathered from these interviews, as well as consultation from an advisory~     board of young MSM and HIV prevention experts. Last, we will use an experimental design to~     compare our intervention to a control condition. We hypothesize that, relative to a control~     condition of sexual health education and risk reduction, participants in our intervention~     will demonstrate lower rates of HIV risk behavior, find participation more feasible, and~     endorse greater acceptability of our intervention.~   "
98234|NCT01771224|"~     Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause~     intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional~     treatment is not effective; therefore, alternative therapies may be effective specially in~     UC patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The~     increasing incidence and prevalence of UC and ineffective treatments in some patients,~     allows search coadjuvant therapies. Objective: Quantification of differences between~     patients with and without FA. Methods: In two groups of patients with UC is administered FA~     and placebo. We will measure the changes clinical, endoscopic and histological in both~     groups, before and after treatment.~   "
98235|NCT01771211|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     improve word-retrieval in Mild Cognitive Impairment (MCI).~   "
98236|NCT01771198|"~     The purpose of this study is to investigate the clinical efficacy of oral treatment with a~     statin, SIMVASTATIN 40mg, in a target population of patients with severe chronic~     rhinosinusitis resistant to surgery followed by conventional medical and surgical treatment.~   "
98237|NCT01771185|"~     Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for~     diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and~     glucose homeostasis occurs within days after surgery before significant weight loss is~     achieved. This observation has led to the notion that bypassing the upper gastrointestinal~     (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In~     fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently~     being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass~     surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies~     have shown that DJBS results in glycemic control in 87% of overweight and obese patients~     with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao~     Paulo before and after their surgical procedure. Washington University investigators will:~     1) provide technical support and guidance to the physicians performing the studies in~     Brazil, 2) process and analyze blood samples obtained from the study at the Washington~     University Center for Human Nutrition, and 3) be involved in analyzing the data and writing~     the final manuscripts. The effects of DJBS on the following clinical and metabolic~     parameters will be evaluated~   "
98238|NCT01771172|"~     To assess the defibrillation efficacy of a subcutaneous defibrillation system.~   "
98239|NCT01771159|"~     Spinal Cord Injured [SCI] patients typically cannot pee. Injury to the spinal cord~     disrupts the in-coming and out-going brain signals that coordinate bladder sensation and the~     emptying of bladder. SCI typically causes chronic retention of urine with uncontrolled~     leakage of urine. Some form of tube (catheter) is needed to drain the urine except with the~     mildest forms of SCI. Two types of tubes to drain the urine have been used for many years.~     These types are the urethral (inserted into the bladder through the opening usually used to~     empty the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder~     through the abdomen).~      Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick~     to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in~     24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10~     million per cubic centimeter in 48 hours which causes infection. Oral drugs and~     antibiotic-coated catheters delay this process by a week or two, but within a month 100% of~     patients have bacteria in their urine. Existing drugs cannot eliminate these microbial~     sanctuaries.~      The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is~     permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter~     is temporarily connected to the TBC that is easily replaceable in the clinic without~     anesthesia or special instruments. It locks to form a water-tight system. Many parts of the~     TBC are coated with an antibacterial substance that will delay the growth of bacteria. The~     TBC has been used with success in multiple animal studies.~      This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured~     patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit~     sites will be photographed monthly and tested periodically to document growth of any~     bacteria. Every three months, patients will complete satisfaction questionnaires and their~     urine will be tested for bacteria. Urine will also be tested as clinically indicated.~   "
98240|NCT01771146|"~     A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic~     pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)~   "
98241|NCT01771133|"~     The investigators propose to conduct a randomized controlled trial in 200 overweight/obese~     pregnant women and their offspring. The prenatal intervention will emphasize improving diet~     and physical activity. The lifestyle intervention will be delivered within an empowerment~     theoretical framework through a combination of group sessions, individual counseling, and by~     monitoring compliance to diet and physical activity to further tailor the intervention. The~     post-partum intervention sessions will include mothers and their offspring and will focus on~     breastfeeding, improving physical activity and quality of the diet and feeding practices~     through the first post-partum year. As part of routine prenatal care, participants in both~     the control and intervention arms will be given health-related advice. Since the majority of~     participants are expected to be eligible for the Women, Infants and Children (WIC) program,~     both groups will also receive assistance through WIC as per their routine policies. Our~     primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is~     infant BMI z-score at 12 months of age, and the investigators will also be evaluating~     several metabolic outcomes in mothers and infants.~   "
98242|NCT01771120|"~     An observational cross-sectional study will include 750 individuals of all ages, divided in~     4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients~     with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported~     diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory~     symptoms or diseases (n=300)~   "
98243|NCT01771107|"~     This pilot phase I/II trial studies the side effects and the best dose of brentuximab~     vedotin when given together with combination chemotherapy and to see how well they work in~     treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin~     lymphoma. Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in~     different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving brentuximab vedotin together with combination~     chemotherapy may kill more cancer cells.~   "
98244|NCT01771094|"~     The purpose of this study is to determine if water and diet soft drinks with different~     levels of sweeteners have the same effect on thirst.~   "
98245|NCT01771081|"~     POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with~     central involvement to assess the effectiveness of existing anti-vascular endothelial growth~     factor (anti-VEGF) treatment regimens.~   "
98246|NCT01771068|"~     The present study aims to examine the effectiveness of a parenting intervention, the Triple~     P Positive Parenting Program Level 3 discussion groups dealing with disobedience. Triple P~     is a system of interventions to support families and was developed at the University of~     Queensland in Australia in the 1980's. As few studies have tested the effectiveness of~     parenting programs in developing countries, the present study took place in a developing~     country, Panama.~      In a recent study carried out in Australia, this same intervention was found effective in~     reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam,~     Milne & Sanders, 2011).~   "
98247|NCT01771055|"~     The purpose of this study is to find if direct peritoneal resuscitation helps blood flow~     through important organs in a person's body after they have had a traumatic injury with~     massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot~     close the muscles and skin of a patient's belly, because of swelling. This study will also~     try to find if direct peritoneal resuscitation decreases tissue swelling and allows for~     quicker closure of of a patient's belly.~   "
98248|NCT01771042|"~     Elevated subconscious nervous system activity is a characteristic of the obese state and~     contributes importantly to the risk of heart disease and diabetes. This project will compare~     sympathetic nervous system activity and function in a group of obese persons with differing~     levels of sugar tolerance (normal, impaired and type 2 diabetic). Inter-relationships with~     insulin action, blood pressure, heart and kidney function will be determined before and~     after a 4-month weight loss and 3-month weight loss maintenance program.~      It is hypothesized that the transition from normal sugar tolerance to impaired sugar~     tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system~     dysfunction. Furthermore, that weight loss will favorably improve sympathetic function, with~     greatest benefits occurring in those subjects who are insulin resistant with high blood~     insulin concentration.~   "
98249|NCT01771029|"~     Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under~     routine conditions with native patient samples. The clinical validation is planned as a~     method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT).~     The study hypothesis is to show a highest correlation between the new product and the~     reference methods.~   "
98250|NCT01771016|"~     Retrospective analysis of requests of emergency hormonal contraception using pharmacy~     protocols registered in 2003 and 2006.~   "
98251|NCT01771003|"~     Partial Nephrectomy has become the standard treatment in patients with tumours <7cm (T1).~     Even though this is a nephron sparing surgery, there is still potential for acute kidney~     injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent~     acute kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning~     involves applying a blood pressure cuff and inflating and deflating several times~     immediately prior to surgery.~   "
98252|NCT01770990|"~     This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT)~     interventions for patients with mild to moderate depression. Both interventions consist of~     one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed~     cognitive-behavioral psychotherapist accompanied by the study of educational materials and~     the completion of regular monitoring questionnaires (total treatment duration: approximately~     3 months). Patients are randomized into one of two conditions: Patients in the condition~     Tel-PT including mail additionally receive a motivating letter from their psychotherapist~     after each telephone session, while patients in the condition Tel-PT without mail receive~     no further interventions. Patients refusing to be randomized are to be assigned to the~     condition Tel-PT without mail. This study takes place within a larger study evaluating a~     stepped care model for depression (01KQ1002B-TP7).~   "
98286|NCT01770548|"~     Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism~   "
98258|NCT01770912|"~     The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid~     injection is more efficacious than a placebo injection based on standard pain and physical~     measures that are recorded before and after treatment.~      All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical~     care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing~     followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this~     is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc~     (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A~     pregnancy test (urine test) will be conducted on all women of child-bearing age to verify~     that the patient is not pregnant before the rinsing procedure. The patient will fill out a~     short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.~   "
98259|NCT01770899|"~     The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair)~     given with other standard asthma medications and treatments in the treatment of children~     with status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond~     to standard intermittent treatments but requires a continuous medication to aid in~     breathing. While new medications have been used to better manage chronic asthma, acute~     asthma exacerbations continue to be a significant cause of hospitalization and even death in~     children. Oral montelukast is a very safe medication that is used to manage chronic asthma~     in children, but it has not been studied for use in status asthmaticus. If oral montelukast,~     given with other standard therapies, can reduce the treatment length associated with severe,~     acute asthma exacerbations in children, it could potentially improve both the morbidity and~     burden of pediatric asthma.~   "
98260|NCT01770886|"~     A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety,~     pharmacokinetic and pharmacodynamic data will be collected.~   "
98261|NCT01770873|"~     The purpose of this study is to test whether a violence prevention curriculum delivered by~     Big Brothers and Big Sisters staff and mentors can reduce violence involvement for~     assault-injured youth.~   "
98262|NCT01770860|"~     This two-week study will compare the healing of minor wounds when no bandage is applied~     against four different types of bandages.~      The study investigators will make five small wounds similar to scrapes (about a half-inch~     square) on the back of subjects who qualify to participate in the trial and have given~     informed consent. Four of the wounds will be covered by different bandages and one will be~     left uncovered. Participants will visit the clinic every day for 2 weeks or until all the~     wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the~     doctor will score the wounds, a picture will be taken of the wounds and new bandages will be~     applied.~      It is expected that some pain and itching will be experienced, because they are part of the~     normal wound healing process. Subjects will be asked about adverse events at each visit and~     will have the opportunity to discuss issues or concerns with the investigator or the doctor~     during the course of the trial. It is expected that the wounds will be completely healed~     within 14 days, but if not, the participant will need to return to the clinic for follow-up~     treatment until the wounds are completely healed.~      We will see if the different bandages help with the healing of the wounds during the study.~   "
98263|NCT01770847|"~     Diurnal variations in the cardiovascular system apparent in healthy individuals, are~     different in chronic kidney disease patients. Therefore, diurnal variations in arterial~     stiffness may also differ in chronic kidney disease patients. This study aims to identify~     and evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and~     compare them to those in age matched healthy controls.~   "
98264|NCT01770834|"~     This prospective, observational study will evaluate the efficacy, safety and tolerability of~     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid~     arthritis who have had an inadequate response or are intolerant to one or more conventional~     disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on~     RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24,~     and at 3 and 6 months after the last dose of study drug.~   "
98265|NCT01770821|"~     Patients with critical illness loose bodymass, mainly muscle. The purpose of the present~     study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich)~     have effect on the six minutes walking test (6MWT), muscle strength, body weight, body~     composition and quality of life after intensive care. This is a single center randomised~     controled study comprising patients ≥45 years of age staying 5 days or more in the intensive~     care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving~     the ICU.~   "
98266|NCT01770808|"~     Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered~     bowel habit, flatulence and bloating and can sometimes result from slower intestinal transit~     and other digestive irregularities.~      The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal~     and AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed~     gastrointestinal disorders.~   "
98267|NCT01770795|"~     To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated~     paclitaxel)and gemcitabine in untreated metastatic NSCLC patients~   "
98268|NCT01770782|"~     The objective of this study was to evaluate the effect of the orthodontic retainer on~     transverse maxillary dental and skeletal stability after SARME.~   "
98269|NCT01770769|"~     Clinical research during the last ten years has revealed that elderly patients with a~     displaced femoral neck fracture should be treated with arthroplasty instead of closed~     reduction of the fracture followed by internal fixation with pins or screws. Few clinical~     trials have addressed undisplaced or minimally displaced fractures of the femoral neck.~     These fractures have been associated with a good prognosis and likewise a good functional~     outcome. However, recent articles present far less favorable results, with high re-operation~     rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect~     comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and~     lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged~     70 years or older are minimally displaced or undisplaced. Hence the investigators call for a~     randomised controlled trial comparing pain, function, walking ability, quality of life,~     re-operation rates and complications after internal fixation versus hemiarthroplasty in~     patients aged 70 years and older.~   "
98272|NCT01770730|"~     The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB~     diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with~     increasing illness severity and more advanced immunosuppression, thus offering the greatest~     potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4~     cell count less than 200). However, in the context of high rates of empiric treatment and~     the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip~     test is unknown. This study will investigate the impact of the urine LAM strip test. The~     study hypothesis is that the urine LAM strip test, when combined with standard TB~     diagnostics (smear microscopy and culture) will significantly improve TB treatment-related~     outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected~     hospitalized patients when compared to standard TB diagnostics alone.~   "
98273|NCT01770717|"~     Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill~     patients. Pressure ulcers result in significant pain, changing quality of life, and often~     leading to significant morbidity and prolonged hospital stays, and ultimately increased the~     healthcare cost.~      According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital~     acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This~     survey also indicated that the highest rate of pressure ulcers is in the long term acute~     care population (22%).~   "
98274|NCT01770704|"~     The objective of the ambispective cohort study is to describe clinical management and~     clinical outcomes related to bipolar disorder in China, and establish the factors associated~     with different management patterns and clinical outcomes, provide psychiatrists with~     reliable and up-to-date information on the disease.~   "
98275|NCT01770691|"~     Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by~     loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing,~     running, lifting or walking. SUI cause women to avoid routine physical activities, thus~     detracting significantly from their quality of life.~      The purpose of this study is to evaluate the performance of new designs of the TIPI device,~     a conservative, disposable, treatment for temporary management of SUI.~   "
98276|NCT01770678|"~     Cerebral palsy remains a major cause of lifelong disability affecting approximately 2 per~     1,000 children. Of those about 30% have hemiplegic cerebral palsy (HPC),a unilateral~     impairment, which can often lead to major difficulties with manual dexterity and upper~     limb,functional ability and independence. Therapists employ a number of strategies in upper~     limb rehabilitation however they are poorly understood and their efficacy has been~     questioned. Constraint induced movement therapy (CIMT)has been found to be an effective~     intervention with HCP however its use in the preschool child within a national health~     service (NHS) setting has not been evaluated. The investigators aim is to compare CIMT using~     prolonged restraint with CIMT using brief manual restraint which may be standard practice~     and acts as the control. This age group has been targeted as there may be greatest neural~     plasticity (change)and minimal disruption to compulsory education. The investigators intend~     to recruit 60 patients from treatment databases of participating trusts. Patients will be~     randomised following baseline assessments which will include 2 upper limb assessments(The~     Assisting Hand Assessment and the Quality of Upper Extremity Skills Test) and a quality of~     life questionnaire (PedsQL Generic Core Scales and the Cerebral Palsy Module) for parents.~     The intervention period will be for 6 weeks offered intermittently (2week blocks) over 10~     weeks. Parents /guardians and possibly preschool workers will be expected to carry out a~     therapy guided programme. The amount of intervention and compliance will be recorded by~     parents/guardians and therapists. Assessments will be repeated at 10 weeks and 24 weeks from~     the beginning of the trial. The results of the trial will contribute to the evidence on the~     effectiveness of CIMT in the preschool child with HCP, and will also provide evidence on the~     implementation of CIMT delivery within the current NHS therapy services.~   "
98277|NCT01770665|"~     Testing Mayo Clinic cancer patients with the results being correlated with prior patient~     therapy, performance status, and extent of disease.~   "
98278|NCT01770652|"~     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the~     effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide~     metabolite following a single oral dose of 33mg/kg Ferriprox®.~   "
98279|NCT01770639|"~     The aim of this study is to investigate the clinical outcomes of surgical correction of foot~     deformity with the MFB in a larger group of patients with neurological impairment of the~     foot.~   "
98280|NCT01770626|"~     The study is designed to evaluate how the composition of a participant's body, diagnosed~     with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance~     analysis can predict the progression and outcomes of disease.~   "
98281|NCT01770613|"~     The purpose of this study is to assess the safety and tolerability of human allogeneic~     mesenchymal bone marrow cells (aMBMC) administered intravenously to subjects with ST Segment~     Elevation Myocardial Infarction (STEMI).~   "
98282|NCT01770600|"~     This study is dedicated to achieving a better understanding of how the brain processes~     information. Specifically, the investigators are studying cognitive function, thought~     process, and impulsivity in people with and without suicidal thoughts. You are being asked~     to participate in a research study to learn how the use of a medication, risperidone,~     improves your symptoms of depression. Specifically the investigators are studying the~     effectiveness of reducing the thought of suicide and other symptoms of severe depression.~     Risperidone is approved by FDA for the treatment of schizophrenia and bipolar mania, and~     clinical practice suggests that it might benefit patients with major depressive disorder.~     During clinical trials with 2607 patients, risperidone was proved to be safe. This is a~     pilot study to test a new indication of risperidone for treatment of severe depression. The~     study medication will be given in addition to usual psychiatric care.~   "
98283|NCT01770587|"~     An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal~     ideation.~   "
98284|NCT01770574|"~     The purpose of this study is to determine whether structural calcium ceramic bone graft~     substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone~     graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces~     postoperative pain.~      To groups of patients (age 5-16) will be compared. One group randomized to autologous bone~     graft and the other group randomized to calcium ceramic.~      The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported~     outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog~     scale and numerical range scale).~   "
98285|NCT01770561|"~     The purpose of this study is to collect performance data on the integrated sensor and~     infusion set during 3 days of use and demonstrate performance adequacy of the Integrated~     sensor and infusion set with glucose sensing and insulin delivery functionalities. The~     hypothesis of this study is that having the infusion of insulin in close proximity to the~     sensor does not interfere with the sensor accuracy.~   "
98288|NCT01770522|"~     It is well known that being overweight or obese increases the risk of health problems, and~     that many people find it difficult to maintain a healthy weight. Worryingly the rise in~     obesity is greater in women than in the male population. One possible reason for this is~     that some women gain too much weight during their pregnancy and find it difficult to lose~     this weight after the birth of their baby. For example, women who gain more weight than~     recommended during pregnancy have been shown to be more likely to carry excess that weight~     at 1 and 15 years after pregnancy, compared to women who gained the recommended amount of~     weight.~      There are currently no evidence-based guidelines in the UK for how weight should be managed~     during pregnancy. For these reasons, it is really important that we understand the factors~     affecting weight management before, during and after pregnancy.~      The aim of this research is therefore to find successful approaches to help women manage~     their weight before, during and after pregnancy. This will be completed by understanding the~     knowledge, attitudes, experiences and expectations of women during and after pregnancy and~     to identify the factors (e.g. diet, physical activity, poor social network etc.) which~     influence body weight. This will enable us to suggest better strategies for promoting~     healthy weight changes during and after pregnancy.~   "
98289|NCT01770509|"~     Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are~     common in patients older than 65 years and cause a significant morbidity.~      Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a~     mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural~     Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of~     venous stasis and post-erysipelas leg ulcers.~   "
98290|NCT01770496|"~     The objective of this study was to assess the relative effectiveness of reminder/recall~     strategies among children who live in an urban area targeting alternative age-specific~     milestones.~   "
98291|NCT01770483|"~     The purpose of this study is to investigate if nitazoxanide used in combination with~     interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic~     patients by improving their sustained viral response by more than 80%.Considering that the~     study is being conducted in a third world country like Pakistan, the standard treatment of~     hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in~     efficacy to peginterferon and also cost effective.~   "
98292|NCT01770470|"~     The purpose of the pilot study is to determine the impact of short-term administration of~     chitosan-containing chewing gum on phosphate levels in patients with elevated serum~     phosphate levels.~   "
98293|NCT01770457|"~     This study is designed to examine the early sequential cytokine responses during antibiotic~     therapy and resuscitation of septic shock in relation to clinical manifestations of disease.~      The specific objective is to obtain sequential serum samples from patients with septic~     shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc)~     in a rigorous manner and correlate these responses to administration of antibiotics,~     resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC,~     etc).~   "
98294|NCT01770444|"~     This study is to see whether the low-dose coronary computed tomographic angiography (CCTA)~     protocol is as safe and efficacious as conventional-dose protocol in early triage of acute~     chest pain.~   "
98295|NCT01770431|"~     To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and~     metastasis of hepatocarcinoma after radical hepatectomy.~   "
98296|NCT01770418|"~     The purpose of this research study is to compare the effects (good and bad) on subjects and~     their cancer using standard chemotherapy in combination with hypofractionated proton~     radiation therapy. Hypofractionation is a technique that delivers higher daily doses of~     radiation over a shorter period of time.~   "
98297|NCT01770405|"~     This study focuses on four different lesions: pancreatic cysts, lymph nodes near the~     gastrointestinal tract, pancreatic masses and GIST tumors.~      On one hand, the results obtained during previous studies are more advanced for the~     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser~     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have~     already been performed, and an interpretation criteria classification exists. On the other~     hand, results for pancreatic masses, Lymph nodes and GIST are less developed.~      the objectives of the study are to~        -  Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser~          Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas,~          lymph nodes, submucosal lesions of the GI tract~        -  Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of~          the pancreas, lymph nodes, submucosal lesions of the GI tract~   "
98298|NCT01770392|"~     To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters~     of nintedanib~   "
98299|NCT01770379|"~     This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)~     for subcutaneous self-administration in patients with active rheumatoid arthritis who are~     intolerant to or have had an inadequate response to anti-TNF-α agents.~   "
98300|NCT01770366|"~     Obesity affects over one-third of the US population, and is associated with serious medical~     problems like diabetes and heart disease. Weight loss surgery is the most effective~     treatment for obesity, but some weight loss surgery patients lose less weight than others,~     and some patients regain the weight they lost. Researchers have found that support groups~     help post-surgical patients lose more weight, but long-term support programs often aren't~     available or are difficult for patients to get to. Physical activity is also important for~     weight loss surgery patients, but most post-surgical support programs don't focus on helping~     patients exercise. Our pilot study will test an Internet-based weight loss surgery support~     program that patients can use from home, and will include new devices such as wireless~     weight scales and wireless pedometers to help patients track their weight loss and physical~     activity and share their progress with their clinicians over the Internet. If successful,~     our support intervention will help more patients successfully lose weight after surgery, and~     therefore will improve their long-term health.~   "
98301|NCT01770353|"~     This is a Phase I Pilot study to understand the biodistribution of MM-398 and to determine~     the feasibility of using Ferumoxytol as a tumor imaging agent.~   "
98362|NCT01769560|"~     This study will test whether a tailored, online educational intervention increases HPV~     vaccine uptake and intent among female college students.~   "
98302|NCT01770340|"~     Earlier studies were able to show that an improvement of the erectile function following a~     non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.~      The investigators evaluate the use of the implantation of the allogenic nerve graft Avance®~     in patients undergoing non nerve-sparing radical prostatectomy.~   "
98303|NCT01770327|"~     The purpose of this study is to determine if water and three different sugary beverages~     (milk, Orange juice and iced tea) have the same effect on thirst.~   "
98304|NCT01770314|"~     The purpose of this project is to test whether an online pain medication intervention is a~     feasible and effective way to increase opioid pain medication safety.~   "
98305|NCT01770301|"~     Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood~     vessels (a process called angiogenesis). This can reduce blood flow of the tumor and then~     decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the~     tumor from growing.~      In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the~     bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already~     benefits from a marketing authorization (MMA) for these various types of cancers.~      The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most~     frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication~     demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is~     ended.~      This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal~     since this tumors are very well vascularized.~      The ALIENOR study aims to explore the interest and the clinical benefit of associating~     bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords-~     stromal tumor treated beforehand by platinum chemotherapy~   "
98306|NCT01770288|"~     During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces~     high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is~     a marker to the increased protons concentration and acidosis.nevertheless, the increased~     level of protons in addition to the release of bradykinin causes pain during the exercise~     that limited the subject's performance. Therefore, it is assumed that the individual pain~     sensitivity might determine the subject's performance.~      Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance~     in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain~     during anaerobic exercise and its contribution to the subjects' performance (3) to assess~     the function of pain-related psychological factors in anaerobic performance.~   "
98307|NCT01770275|"~     Background. The aim of our study was to investigate the ability of the Seventh edition of~     the classification by the International Union Against Cancer (UICC) to identify patients at~     higher risk and to predict the overall survival in patients with esophageal carcinoma.~     Methods. Demographic and clinical data of 605 patients, who underwent esophagectomy for~     esophageal carcinoma between 1992 and 2009, were analyzed. Tumor stage and grade were~     classified according to the sixth and seventh editions of the UICC classification.~   "
98308|NCT01770262|"~     Lack in vitamin D reduces the absorption of calcium in the body, accelerates bone loss and~     may increase the risk of fractures due to osteoporosis. An algorithm that will allow~     immediate and non-invasive quantification of vitamin D levels will shorten the time of~     diagnosis, reduce lab costs and prevent hazards or discomfort to the patient associated with~     a blood test.~      The goal of the study is therefore to develop a non-invasive method for quantifying vitamin~     D levels in the body using spectroscopy.~      40 subjects will be recruited: 20 hospitalized patients in the rehabilitation department,~     diagnosed with osteoporosis and 20 healthy subjects. Spectroscopy will be used with visible~     light on the subject's skin and middle infrared (MIR) on the blood sample to find~     correlation with the chemical lab test results.~   "
98309|NCT01770249|"~     This study is to evaluate outcomes of a less invasive surgical procedure for the treatment~     of achalasia.~   "
98310|NCT01770236|"~     The purpose of this study is to compare postoperative pain control after minimally invasive~     coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic~     medicine injected in an area under the ribs) in the operating room and IV acetaminophen~     (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon~     pump attached to 2 small tubes near your procedure site that automatically delivers pain~     medicine).~   "
98311|NCT01770223|"~     This study is being done to find out if participants with insulin resistance and hepatitis C~     virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa~     (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV~     (triple therapy).~   "
98312|NCT01770210|"~     In western societies hypercholesterolemia is one of the major and independent factors that~     predispose to cardiovascular disease and death from them. According to the clinical study~     ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women,~     rates of hypercholesterolemia observed in a sample of urban population was 39% for men and~     37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52%~     for men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk~     of cardiovascular disease appears to be quite clear in the secondary prevention trials, the~     4S (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and~     LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the~     benefits of lowering LDL cholesterol in patients with coronary artery disease. Despite these~     remarkable results, studies were secondary prevention as a major shortcoming, the lack of~     patients with acute coronary events. This gap came to cover the study MIRACL (Myocardial~     Ischemia Reduction with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80~     mg was evaluated in 3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute~     coronary syndrome (myocardial infarction without Q-wave or unstable angina). Treatment was~     initiated during the acute phase after hospital admission and lasted for a period of 16~     weeks. Treatment with atorvastatin 80 mg / day increased the latency of the combined primary~     endpoint, defined as death from any cause, nonfatal myocardial infarction, resuscitated~     cardiac arrest, or angina with objective evidence of myocardial ischemia requiring admission~     to hospital, indicating a risk reduction of 16% (p = 0,048). This was mainly due to a 26%~     reduction in re-hospitalization for angina with objective evidence of myocardial ischemia.~     The other secondary endpoints were not statistically significant by themselves (total:~     placebo: 22.2%, Atorvastatin: 22.4%).~      Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence~     of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence~     of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and~     8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P~     <0,015) nationwide with the appearance episode (event) CV.~   "
98363|NCT01769547|"~     This is a single-arm, open label, two stage, phase II study of dovitinib in patients with~     advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to~     evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM~     using progression free survival (PFS).~   "
98313|NCT01770197|"~     The time window for intravenous recombinant tissue plasminogen activator treatment in~     ischemic stroke patients has been extended to 4.5h. Little is known about intravenous~     recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese~     stroke patients. This exploratory study was to describe the feasibility and outcome of~     treatment with intravenous recombinant tissue plasminogen activator in the expanded time~     window, and to offer suggestions for future clinical work in China.~   "
98314|NCT01770184|"~     Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10~     years which is in large part due to the cyclical relationship of chronic disease, poor~     health, and mild stroke which has gone largely unnoticed in the United States.~     Self-management intervention has been proven to be an effective intervention to increase~     healthy behaviors, improve overall health status, decrease healthcare utilization/cost,~     decrease depressive symptoms, and improve participation in people with a variety of chronic~     conditions; however, it has never be used with individuals with mild stroke. The critical~     next step and goal of this study is to evaluate if self-management intervention will improve~     health outcomes for persons with mild stroke. The overall hypothesis of this study is that~     self-management intervention will improve outcomes in the mild-stroke population.~   "
98315|NCT01770171|"~     Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11~     patients with advanced/recurrent endometrial cancers. All patients had multi-site disease~     and were heavily pretreated with a median of 3 prior chemotherapy regimens. All received~     bevacizumab combination therapy which was well-tolerated. Two patients had partial~     responses, 3 had stable disease, while 5 patients progressed. One subject was not assessable~     for response. The median progression-free interval was 5.4 months for the entire cohort and~     8.7 months for those who achieved clinical benefit (PR or SD). The authors concluded that~     Bevacizumab was well-tolerated and displayed promising anti-neoplastic activity in patients~     with endometrial cancer.The rationale for combining anti-angiogenic agents, including~     anti-VEGF antibodies, with cytotoxic chemotherapy stems from a number of preclinical studies~     showing additive and synergistic anti-tumour activity in a number of solid tumour types. By~     combining VEGF-targeting agents such as bevacizumab with conventional chemotherapies, it is~     hoped that these agents will act synergistically, thereby enhancing their anti-tumour~     efficacy and controlling disease progression.~      The addition of bevacizumab to chemotherapy has been shown to improve PFS and/or OS in a~     series of large, randomized Phase III clinical trials in a wide range of tumour types,~     including mCRC, non-squamous NSCLC, metastatic BC (mBC) and mRCC.~   "
98316|NCT01770158|"~     This is a non-interventional multi-center study (NIS) in adult patients with AML in first~     complete remission with measurable minimal residual disease (MRD). Patients are eligible~     when gene status was already determined for previous induction and consolidation therapy of~     AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to~     observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and~     interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to~     monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first~     complete remission. Therapy is administered for 10 treatment cycles as outlined in the~     Summary of Product Characteristics.~   "
98317|NCT01770145|"~     This study is designed to assess the effect of APOKYN treatment in rapid and reliable~     improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or~     unreliable onset of levodopa (L-dopa) action.~   "
98318|NCT01770132|"~     This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic~     therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating~     patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer~     sodium, that becomes active when it is exposed to a certain kind of light. When the drug is~     active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving photodynamic therapy together with~     gemcitabine hydrochloride may be effect in patients with pancreatic cancer.~   "
98319|NCT01770119|"~     Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed~     children. Currently, measles vaccine is not recommended in pediatric orthotopic liver~     transplant recipients, because it is a live-attenuated vaccine.~      We want to assess the influence of immunosuppression on immunity against measles in~     previously vaccinated children and to evaluate the induction of B cell and T cell response~     against measles elicited by vaccination in children at least 12 months after~     transplantation.~   "
98320|NCT01770106|"~     The aim of this study is to compare the effects of denosumab and a current standard~     treatment on cortical and trabecular microarchitecture at the radius and second metacarpal~     in rheumatoid arthritis (RA) patients with low bone mineral density using high resolution~     peripheral quantitative computed tomography (HR-pQCT) during a 6-month open-label randomized~     controlled study. Forty ambulatory Chinese females, who consent to receive alendronate as~     standard treatment subjective to the randomization, will be enrolled in this study. Subjects~     will be randomized to 2 arms receiving: 1) subcutaneous injection of denosumab 60mg~     (Prolia®) every 6 months (n=20), or 2) oral alendronate weekly (Fosamax® once weekly 70 mg,~     n=20). In addition, all patients will be given a daily calcium supplement (1500mg caltrate~     /day) and 1 multivitamin tablet per day. Efficacy and safety assessment will be performed at~     baseline, month 3 and month 6. aBMD of lumbar spine, total hip and non-dominant distal~     radius will be measured using dual-energy X-ray absorptiometry (DXA) and microarchitecture~     of bone is measured at the non-dominant distal radius and the second metacarpal bone of the~     non-dominant hand using HR-pQCT.~   "
98321|NCT01770093|"~     Several studies have been conducted throughout the world to evaluate patients' and parents'~     preferences regarding physicians' attire. Most studies have shown that the attire influences~     their feelings trust and confidence regarding their care. In most countries the preference~     is for formal attire. In other places a more casual attire is generally accepted. Israel is~     a country where casual dress is acceptable in most settings. Israeli physician's dress code~     has been discussed in the past, but has never been systematically studied. The aim of this~     study is to systematically examine the attitudes of parents of children who have been~     admitted to the pediatric ward towards physicians' attire.~   "
98364|NCT01769534|"~     The purpose of this study is to follow patients, who have small mucinous cysts in the~     pancreas, prospectively over a 5-year period.~   "
98322|NCT01770080|"~     Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use)~     compared to placebo in patients with episodic tension-type headache (ETTH).~      Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups~     design; Randomisation 1:1; First attack per patient will be evaluated for primary~     objectives, following attacks during study duration will be observed and documented.~      Study duration per patient: 10 weeks~   "
98323|NCT01770067|"~     Following previous positive experience with CITA-RNPT of infected pacemakers, we suggest~     that CITA-RNPT can be administered prophylactically to patients prior to replacement of~     CIED, immun-compromised patients, and others.~   "
98324|NCT01770054|"~     A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in~     Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the~     metabolic syndrome in adults aged 40 years or more living in this rural village of coastal~     Ecuador.~   "
98325|NCT01770041|"~     This observational study will assess the metabolic pathways of paracetamol that are utilised~     after liver resection.~   "
98326|NCT01770028|"~     The primary aim of the proposed study is to determine whether lifestyle interventions to~     prevent excessive gestational weight gain in overweight/obese pregnant women have positive~     ripple effects on untreated partners in the home. We hypothesize that partners of pregnant~     women randomized to the lifestyle intervention, relative to those of standard care, will~     have greater weight losses through 12-months. Secondary aims examine partner improvements in~     weight control behaviors, the home environment, and psychosocial parameters.~   "
98327|NCT01770015|"~     Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side,~     bronchial fungi colonization is commonly observed in ICU; therefore, the investigators~     propose to study the role of bronchial fungi colonization on the occurrence of VAP taking~     into account the immune status of the patient and the antibiotic and antifungal treatments~     he has received.~   "
98328|NCT01770002|"~     The investigators hypothesize that everting wound edges while suturing surgical sites will~     result in more aesthetic scars. Additionally, we also hypothesize that small to moderate~     wound irregularities present at 3 months will resolve by 6 months after surgery with no~     intervention~   "
98329|NCT01769989|"~     The purpose of this study is to determine if electrodermabrasion improves the cosmetic~     appearance of raise or bumpy scars or scars that are a different color or texture than the~     surrounding skin resulting from dermatologic surgery and whether it is as good as to the~     already used method of dermabrasion.~   "
98330|NCT01769976|"~     The aim of this study is to examine whether periodic fasting improves markers of diabetes~     risk and cardiovascular health, and will compare this to the effects observed with daily~     dieting by energy restriction, and also with no change in energy intake.~      It is hypothesized that periodic fasting, with or without weight loss, will be as effective~     as daily energy restriction to improve markers of metabolic health and energy metabolism.~   "
98331|NCT01769963|"~     The purpose of the study is to learn more about how advanced glycation end-products can~     affect insulin resistance, inflammation and blood vessel health in people with kidney~     disease.~   "
98332|NCT01769950|"~     Nodal involvement among patients with prostate cancer is known to be a poor prognostic~     factor. Traditionally, the presence or absence of nodal disease in patients with prostate~     cancer is ascertained with the use of anatomical imaging methods such as computed tomography~     (CT) and magnetic resonance imaging (MRI).~      However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather~     low, with reports placing the value to lie between 50-80%.~      Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline~     (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of~     prostate cancer disease burden in the primary, nodal and the metastatic areas.~      The investigators in this prospective trial intend to utilize Choline-PET among all newly~     diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal~     disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional~     imaging).~   "
98333|NCT01769937|"~     Systemic lupus erythematosus is a serious and potentially life-threatening condition with~     significant unmet medical need. The aim of this Investigator Initiated, single center,~     open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ)~     injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for~     non-responders after day 10 dose. The primary objective of this study is to evaluate whether~     the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity~     of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.~   "
98334|NCT01769924|"~     Studies of patients with established kidney disease, even when this is mild, appear to show~     that they are at high risk of heart failure, stroke and sudden cardiac death. This may be~     because kidney disease causes stiffening of the arteries in the body which means that the~     heart and brain are damaged by high blood pressure. By studying patients before and after~     the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find~     out for the first time in man the effect of an isolated reduction in kidney function on the~     structure and function of the cardiovascular system.~   "
98335|NCT01769911|"~     This clinical trial studies genetically modified peripheral blood stem cell transplant in~     treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy~     before a peripheral stem cell transplant stops the growth of cancer cells by stopping them~     from dividing or killing them. After treatment, stem cells are collected from the patient's~     blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone~     marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy and~     radiation therapy~   "
98336|NCT01769898|"~     The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with~     theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.~   "
98337|NCT01769885|"~     This clinical trial studies tivozanib before surgery in treating patients with localized~     kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth~     factors needed for cell growth.~   "
98338|NCT01769872|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     spinal cord injury~   "
98339|NCT01769859|"~     The primary goals of this work are: a) to establish a unique collection of mood disorder~     patients across the life cycle, including children, adults and geriatric patients, with~     well-defined medical co-morbidities and medication treatment outcomes at the University~     Hospitals Case Medical Center Department of Psychiatry; b) to establish a collection of~     nuclear families, including both mothers and fathers, of children diagnosed with mood~     disorders; c) to perform a systematic genetic analysis of the proposed sample repository to~     identify genes and genetic variants contributing to inter-patient variability in clinical~     phenotypes and treatment responses. Our primary hypothesis is that genetic variations may~     underlie individual variability in disease susceptibility, clinical phenotypes and treatment~     safety, tolerability, and effectiveness.~   "
98340|NCT01769846|"~     Advances in intensive care and mechanical ventilation (MV) in the past two decades have~     increased critically ill patient survival. However, some patients require prolonged MV (PMV)~     and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse~     effects of medications, and prolonged immobilization. Patients in the intensive care unit~     (ICU) are often confined to their beds, which results in inactivity, immobility, and severe~     osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol~     improves peripheral muscle strength, perceived functional status, duration of mechanical~     ventilation, ICU length of stay of the critically ill patient.~      The purpose of this study is to evaluate the effects of implementation an early mobilization~     protocol in critically ill patients in the Intensive Care Unit of the University Hospital of~     Santa Maria.~   "
98341|NCT01769833|"~     This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha~     vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg~     levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients~     who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.~   "
98342|NCT01769820|"~     This study builds on previous research which has provided compelling evidence that deficient~     activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding.~     This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use~     for other conditions, (eg to treat medical conditions such as asthma and rheumatoid~     arthritis in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as~     a result reduce menstrual blood loss.~      The study is in two stages, a 12 month workup stage and a 3 year, response adaptive,~     dose-finding randomised controlled trial. The first stage involves two workup clinical~     studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual~     Bleeding use of oral dexamethasone. They will also provide methodological data for a series~     of simulation studies to determine a robust adaptive trial design specification.~      Workup study 1: is unblinded, six patients will be given Dexamethasone (0.75mg twice daily)~     for 5 days during two consecutive menstrual cycles and will have an endometrial biopsy and~     MRI on two occasions (in a nontreated cycle, and the second of the cycles treated with~     Dexamethasone). Workup study 2; is a doubleblind crossover trial of 14 women -2 treatment~     blocks of two cycles each, with either placebo or Dexamethasone (0.75mg twice daily),~     randomised to order of treatments blocks - placebo then Dexamethasone, or vice-versa.~      Adaptive trial: 48 month double-blind, placebo controlled trial of 108 women to evaluate the~     effect of Dexamethasone across a range of doses with the aim of identifying the optimal dose~     to be studied in a subsequent Phase III trial.~      Participants will be randomised to receive one of 6 active doses or placebo over 3 menstrual~     cycles.~      All studies will involve asking participants to complete menstrual diaries and to carry out~     menstrual blood loss collections to objectively measure blood loss.~      The investigators' proposed approach is novel use of synthetic glucocorticoid to rescue~     luteal phase deficiency of cortisol, and thus improve endometrial vasculature and hence~     vasoconstriction when menses commences, and thus reduce menstrual bleeding.~   "
98343|NCT01769807|"~     Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have~     been described in severe obstructive sleep apnea (OSA), and are reverted by continuous~     positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on~     these biomarkers in mild-moderate OSA.~   "
98344|NCT01769794|"~     The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent~     Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot,~     and mouth disease (HFMD).~   "
98345|NCT01769781|"~     The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will~     be tested for the treatment of women with endometriosis recurrence compared with classical~     GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up~     will be the outcomes for establishing which medical treatment is the best in endometriosis~     recurrence treatment.~   "
98346|NCT01769768|"~     This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on~     the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive~     800mg daily of LDE225 and two separate doses of either bupropion or warfarin.~   "
98347|NCT01769755|"~     To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up~     to 5 total infusions in subjects with Crohn's disease who are refractory to one or more~     standard Crohn's disease therapies.~   "
98348|NCT01769742|"~     Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In~     surgical specialities and critical care early physiotherapy is a recognised way of~     preventing such infections, and reducing length of hospital stay (LOS), however prevention~     of this problem is less well studied in medical inpatients.~      The investigators propose a pilot study to assess the impact of introducing an early~     mobilisation strategy to general medical and respiratory wards at an acute Trust in the~     United Kingdom (UK). The investigators will recruit all new admissions to each of 2~     respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive~     extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual~     mobility, current mobility and actual activity levels will be studied by accelerometer and~     simple patient questionnaire in the first 48 hours of admission, and compared between~     groups. Incidence of HAP and total LOS will be recorded and compared between groups.~      The investigators hypotheses are that the physiotherapy intervention will increase activity~     levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the~     National Health Service (NHS), which the investigators will model using local tariff data.~      The investigators plan to use our data to power a larger randomised controlled study, or if~     the intervention is a marked success, such that a control group would be unethical, then a~     wider service development and evaluation programme.~   "
98373|NCT01769417|"~     This is a Phase 1, first time in human study enrolling approximately 33 healthy adult~     subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the~     safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single~     IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll~     sequentially. Subjects will be followed for safety from the time of Informed Consent through~     360 days post dose.~   "
98349|NCT01769729|"~     The overall aim of this program of research is to develop a collaborative psychotherapy for~     major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid~     chronic low back pain (CLBP).~      The purpose of the proposed project is to establish the feasibility and acceptability of a~     research design for an eventual large-scale randomized clinical trial which would test the~     efficacy of PEPP in comparison to a control condition (depression care management).~      To achieve the investigators specific aims, the investigators will conduct a pilot~     randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures~     used in care management) or care management.~   "
98350|NCT01769716|"~     This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic~     umbilical cord blood therapy for children with global developmental delay.~   "
98351|NCT01769703|"~     Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke.~      Background: Although aggressive antithrombotic therapy has been shown to reduce the number~     of new ischemic events following stroke/TIA, this has always been offset by an increase in~     the risk of hemorrhagic transformation. Dabigatran is much safer than previously tested~     antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique~     treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest~     group of cerebrovascular disease patients. A short-term intervention such as 30 days of~     dabigatran treatment has the potential for a very large impact from the population health~     perspective, given the number of patients who may be treated if a benefit can be~     demonstrated.~      Study design:~      This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes~     of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom~     onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose~     of dabigatran will be determined by age and renal function (patients >80 years old and/or~     with GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg~     BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with~     TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of~     </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient~     recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation.~     Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic~     transformation and new lesion development. The primary endpoint of of phase I is symptomatic~     hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE~     sequence), associated with clinical worsening (>/=4 point increase in National Institutes of~     Health Stroke Scale (NIHSS) score).~      If dabigatran can be used safely in this population, a second phase aimed at demonstrating~     the rate of new ischemic lesion development following TIA can be reduced with aggressive~     antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be~     employed. The investigators hypothesize that dabigatran therapy administered within 24 hours~     of symptom onset will reduce the rate of new ischemic lesions, relative to standard care,~     one week and 30 days after onset.~   "
98352|NCT01769690|"~     The study design is a within-subject randomized cross-over design to evaluate the effects of~     DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as~     measured by a virtual reality street-crossing simulator.~   "
98353|NCT01769677|"~     The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone~     bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release~     tablet.~   "
98354|NCT01769664|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to~     the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in~     the treatment of the inflamed lesions of acne vulgaris. Both the test and reference~     formulations will also be compared to a placebo formulation to test for superiority.~   "
98355|NCT01769651|"~     Accurately predicting the risk factors of patients' suffering a drug overdose plays a~     crucial role in effective prevention of drug overdose. In order to investigate possible risk~     factors for drug overdose, the NHS Fife Research & Development Office funded this project to~     be carried out by a group of researchers based in the University of St Andrews, in~     collaboration with the NHS Fife Addiction Services.~      To improve our understanding of drug misusers' risk of suffering a drug overdose, the~     investigators focus on the factors that are associated with the aspects of the addiction~     consultation process (e.g. verbal and non-verbal behaviours of clinicians and patients). The~     investigators are particularly interested in how clinicians recognize and manage patients'~     emotional concerns during consultations. Based on the empirical evidence in the area of~     patient-centred consultation, the investigators hypothesize that successful management of~     patient emotional distress is positively correlated with improved healthcare outcomes~     including patient's feeling more emotionally valued and satisfied with the consultation. The~     investigators also hypothesize, according to the research findings on the relationship~     between facial expressions and suicidal reattempt, that some non-verbal behaviours during~     consultation (e.g. patient's 'looking down' activity) are related to patient's risk of~     suffering a drug overdose.~      After obtaining informed consent from clinicians and patients, the investigators will video~     record a patient's first consultation session with a key worker within the NHS Fife Addition~     Services. The investigators expect to collect a minimum of 16 consultations (about eight~     clinicians with two patients per staff member) for this one-year pilot study. A validated~     coding scheme will be modified to code patients' expressions of emotional distress and~     clinicians' responses. Additional survey method will be also employed to collect demographic~     information and patient satisfaction. The investigators hope the findings of the study will~     improve our understanding of drug overdose risk factors and contribute to the development of~     drug overdose prevention programmes.~   "
98356|NCT01769638|"~     This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally~     disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's Viagra®~     (sildenafil) Film Coated Tablet (FCT) formulation (reference formulation) in healthy~     volunteers.~   "
98357|NCT01769625|"~     This is a biomarker study with the goal of measuring changes in proteins and gene~     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,~     or preventing disease.~      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in~     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act~     together to decrease breast cancer risk by their effect on certain biological indicators~     (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the~     breast.~   "
98358|NCT01769612|"~     The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in~     subjects with suspected CL in Tunisia.~   "
98359|NCT01769599|"~     there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two~     options up to day are using Grid laser treatment Vs. Avastin injections or a combination of~     both in this study we want to compare the two attitudes.~   "
98360|NCT01769586|"~     Patients who are undergoing colonoscopy and are not adequately sedated after initial~     standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to~     receive diphenhydramine vs. continued midazolam, and their level of sedation will be~     assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued~     administration of midazolam during colonoscopy in patients not achieving adequate sedation~     with standard doses of midazolam plus fentanyl.~   "
98361|NCT01769573|"~     This research study will test different doses of RG-HRV16 to find the minimum dose needed to~     give research subjects cold symptoms of at least moderate intensity. The study will also~     test the safety of RG-HRV16. This information will be used in future studies (for example,~     to test antiviral preparations, sprays that could protect from getting a cold or decrease~     cold symptoms or to understand more about how rhinovirus can lead to asthma worsening).~     RG-HRV16 is a common cold virus that has been made in a new way and has not been used in~     humans before.~   "
98365|NCT01769521|"~     Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour~     period, especially in the nocturnal period, may lead to insufficient perfusion pressure of~     the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior~     vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with~     progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced~     mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of~     glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has~     not been studied in a prospective manner and remains to be elucidated.~      The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation~     pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP~     fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device~     using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.~   "
98366|NCT01769508|"~     With improvements in response rate and survival seen for HER2 positive patients treated with~     HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting~     to increase antitumor effect shows promise. Patients with previously untreated localized~     HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients~     meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent~     chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in~     safety portion, the optimal dose of lapatinib will be determined.~   "
98367|NCT01769495|"~     Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic~     discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and~     fewer unplanned hospital admissions with no attendant increase in mortality.~      Patients 75 years of age and older will be randomized following discharge from the ED into~     two groups. The first will receive standard post ED care. The second will receive an~     appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and~     contact with the patient's primary physician to communicate the course of the patient's~     illness and to schedule subsequent follow-up with the patients regular medical provider.~      There will be two primary outcomes: The first will be a composite of morality and/or return~     to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data~     regarding resource utilization by patients will also be analyzed.~   "
98368|NCT01769482|"~     Current therapeutic options for a well-recognized group of patients with anginal symptoms—a~     positive exercise tolerance testing, SPECT or perfusion defect in MRI but angiographically~     normal coronary arteries—are limited. The condition, referred to as microvascular angina~     (MVA) or cardiac syndrome X, is not as benign as originally reported—patients presenting~     with unstable angina and nonobstructive atherosclerotic coronary artery disease have a 2%~     risk of death or myocardial infarction at 30 days of follow-up. It is more common in women~     in whom the first presentation of angina occurs either perimenopausally or postmenopausally.~     Aberrant flow-mediated coronary vasomotion is pivotal in the pathogenesis (systemic)~     impairment in endothelial function. Indeed, some centers use systemic assessments of~     vascular function in their diagnostic pathways for this group of women. It was recently~     suggested that endothelial dysfunction may lead to myocardial ischemia.~      In the present study, the investigators tested the hypothesis that udenafil offers dual~     benefits of improving vascular function and lessening ischemia in women with angina,~     perfusion defect in cardiac MRI, and normal coronary arteries.~   "
98369|NCT01769469|"~     This is a prospective observational cohort sub-study of subjects enrolled in ATN 110 or ATN~     113, which is a prospective interventional trial.~   "
98370|NCT01769456|"~     Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the~     ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine~     Trial Units (AMTUs). Assignment to behavioral intervention, which include Many Men, Many~     Voices (3MV) and Personalized Cognitive Counseling (PCC), will occur at the level of the~     site. Subjects will first complete the behavioral intervention offered at their respective~     site and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF)~     (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be~     collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV~     infected during the course of the study will be discontinued from the study agent and be~     followed for an additional 24 weeks after the study visit at which HIV infection is~     confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or~     the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the~     Extension Phase to more closely monitor longer-term outcome of potential concerns.~   "
98371|NCT01769443|"~     The primary objective is to evaluate the efficacy of desensitization therapy, which includes~     VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart~     transplantation.~   "
98372|NCT01769430|"~     The recent swine origin influenza pandemic (2009), new emergence of swine origin H3N2v, and~     delayed availability of vaccine for these agents highlight the need to test and optimize~     public health intervention strategies to reduce transmission of influenza. We will use a new~     technology for biological particle collection (U.S. Provisional Patent Application No.~     61/162,395, McDevitt et al., Aerosol Sci Technol 2013) to make fundamental observations on~     infectious respiratory droplets in a study of up to 200 naturally occurring seasonal~     influenza cases. We will collect respiratory droplets shed by participants while breathing~     normally, talking, and spontaneously coughing. We will characterize the size distribution of~     droplets containing infectious virus. We will use these basic data to examine the roles of~     large and small respiratory droplets and examine how the interaction of host factors and~     virus type impact the shedding of infectious respiratory droplets. Subjects will be~     recruited through a web based respiratory illness surveillance system, health clinics and~     advertisement in the campus community. Sitting in the collection booth will not create~     additional discomfort or risk for volunteers already suffering from influenza infection. We~     will recruit up to 1000 persons with symptoms of acute respiratory illness for screening~     with collection of nasopharyngeal swabs and questionnaire. From among those screened, we~     will recruit 250 to give exhaled breath samples, and ask 50 people with influenza to return~     for follow up exhaled breath samples on up to two subsequent days. We hypothesize that (1)~     fine aerosols (<5 microns in aerodynamic diameter) will contain more viral copies than~     coarse aerosol particles (>= 5 microns) (2) fine aerosols will contain culturable virus~     indicating that the fine aerosols are infectious, (3) aerosol shedding will correlate with~     virus load measured by swabs, (4) presence of active cough during sampling will be~     associated with increased aerosol shedding, (5) clinical symptoms and signs, including fever~     can be used to predict viral aerosol shedding.~   "
98374|NCT01769404|"~     This study has two parts. Each participant will receive a daily injection of LY2605541~     during one treatment period and a daily injection of insulin glargine during one treatment~     period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood~     sugar levels to see how the body recovers after each treatment.~   "
98375|NCT01769391|"~     The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy~     of paclitaxel and carboplatin is more effective to treat cancer than the standard~     chemotherapy of paclitaxel and carboplatin alone.~   "
98376|NCT01769378|"~     The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide~     compared to placebo in participants with type 2 diabetes who have inadequate glycemic~     control with sulfonylurea monotherapy.~   "
98377|NCT01769365|"~     To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day~     quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected~     patients were randomly assigned to a 7-day standard triple therapy (pantoprazole,~     clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and~     amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a~     further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and~     metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter~     pylori eradication rates between three groups.~   "
98378|NCT01769352|"~     The purpose of this study is to compare the change in visual acuity of patients with post~     surgical cystoid macular edema who will be treated with two different regimens.~   "
98379|NCT01769339|"~     The purpose of this study is to evaluate the efficacy and safety of miconazole plus~     hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast~     infection of the vulva).~   "
98380|NCT01769326|"~     The purpose of this research study is to compare different methods for training hand~     movement at home after stroke. This study involves research because it will test two~     experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to~     conventional hand and arm exercises. The MusicGlove is a glove that measures finger~     movements and allows its user to play a musical computer game using those movements. The RAE~     is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back~     and forth to exercise the arm.~   "
98381|NCT01769313|"~     This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized,~     prospective, single-center, multi-surgeon, investigator masked study to investigate whether~     the femtolaser cataract surgery causes any significant differences in the resulting Intra~     Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous~     curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the~     difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center~     of mass.~   "
98382|NCT01769300|"~     The specific aim of this cluster-randomized (site) comparative effectiveness research study~     is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS~     practices or clinics using an electronic health record (EHR), (3) have attention-deficit~     hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication~     for the first time in these practices, have superior clinical outcomes if their clinicians~     have access to an EHR-guided clinical decision support system (intervention group) than if~     their clinicians have no such access (control group).~   "
98383|NCT01769287|"~     The purpose of this study is to check if at 1 year after surgical ablation the electrical~     impulses that cause atrial fibrillation (AF) are still blocked from being able to get into~     the heart.~      Hypothesis Conduction block and ganglionic destruction are required for freedom from AF.~   "
98384|NCT01769274|"~     The purpose of this study is to evaluate the efficacy and safety of single doses of~     PF-05089771 against placebo in treatment of pain in patients with primary, inherited~     erythromelalgia.~   "
98385|NCT01769261|"~     Evolution of patient's health after hospital discharge is poorly documented. The~     investigators hypothesize that information of good quality on this concern might be~     accessible at a relatively low cost from patients, further referred to as sentinel patients,~     who would voluntary report their health evolution on a dedicated web site.~      The SENTIPAT study presents as a proof of concept study. It will collect patient's health~     evolution during a post-hospital discharge period of 45 days. The study presents as a~     randomized trial comparing patients' reports issued from two different methods in a patient~     population returning home after hospital discharge and having at disposal an internet access~     at home:~      in the  internet  arm, sentinel patients will be solicited to directly report their~     post-discharge health evolution on a website especially devoted for collecting these data~     while in the  telephone  arm, the same items will be collected through a telephone~     interview 45 days after hospital discharge. Investigations will focus on post-discharge~     adverse events and will include appearance/worsening of symptoms, healthcare resources~     utilization, quality of life, and patients' satisfaction.~   "
98386|NCT01769248|"~     Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers~     involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine~     needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes.~     This has traditionally been done with fine needle aspirate where a needle is inserted into~     the tumor and potentially malignant cells are extracted for microscopic analysis. More~     recently, a needle that allows a tissue biopsy for histologic analysis has been FDA~     approved.~      The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to~     provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle~     ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions~     requiring histology for diagnosis. However, there is currently only limited data from~     prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators~     propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA~     to EUS-FNB.~   "
98387|NCT01769235|"~     The objective of this study is to compare the safety and efficacy profiles of Taro~     Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya®~     (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior~     efficacy of the two active formulations over that of the vehicle in the treatment of acne~     vulgaris.~   "
98427|NCT01768715|"~     Patients with alcoholic hepatitis non-responsive to steroids have a poor prognosis. Recently~     a French-Belgian prospective study has obtained good results (acceptable survival with a low~     rate of alcohol recidivism).~      The hypothesis of the present study is that carefully selected Spanish patients with~     alcoholic hepatitis that do not respond to steroid therapy may have a good survival if they~     receive a liver transplant. The expected rate of alcohol recidivism in such a selected~     population will be low.~   "
98388|NCT01769222|"~     This pilot phase I/II trial studies the side effects and best of dose ipilimumab when given~     together with local radiation therapy and to see how well it works in treating patients with~     recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies,~     such as ipilimumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer~     cells. Giving monoclonal antibody therapy together with radiation therapy may be an~     effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer~   "
98389|NCT01769209|"~     This phase II trial studies how well giving bortezomib together with combination~     chemotherapy works in treating patients with relapsed or refractory acute lymphoblastic~     leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
98390|NCT01769196|"~     This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with~     idiopathic pulmonary fibrosis.~   "
98391|NCT01769183|"~     The purpose of this study is to determine the efficacy in the use of topical Squalamine~     Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting~     from proliferative diabetic retinopathy.~   "
98392|NCT01769170|"~     The purpose of this study is to compare the effectiveness of CMX001 to placebo for the~     prevention of CMV infection in stem cell transplant patient who do not have CMV before~     starting treatment with CMX001.~   "
98393|NCT01769157|"~     L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary~     excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine~     supplementation increased excretion of L-carnitine. The investigators hypothesized that~     supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality~     of life, and fatigue score in them. Therefore, the investigators planned to compare the~     efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.~   "
98394|NCT01769144|"~     This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA)~     and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.~   "
98395|NCT01769131|"~     An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for~     mobilization of the cervix during common gynecologic office procedures.~      The primary object is to determine the presence of a difference in pain perception between~     the two instruments.~      The secondary objective is to evaluate the differences in the frequency of bleeding, that~     requires treatment, after removal of the instrument and the need to use an alternative~     instruments.~   "
98396|NCT01769118|"~     Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm~     infant who get caffeine before stopping ventilation. The investigators hypothesis is that~     this stimulatory effect may be characterized by HRV analysis methods.~   "
98397|NCT01769105|"~     Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated~     thermal pulsation with the Lipiflow® system have been reported in several case reports. In~     one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However,~     treatment recommendations for lid hygiene according to the MGD-report consist of~     hyperthermia followed by lid massage and lid margin cleansing over several months. To the~     best of the investigators knowledge this is the first randomized prospective study to~     compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard~     lid hygiene regime.~      The investigators suggest that a single treatment with Lipiflow® is superior to a lid~     hygiene regime.~   "
98398|NCT01769092|"~     For many years, there has been interest in the question of whether a special diet of some~     sort could be used to help control epileptic seizures. The ketogenic diet has been used~     since the 1920s, but it is used only in children, and is nutritionally unbalanced. It is~     typically withdrawn after 3 years. The ketogenic diet unfortunately, offers no long-term~     solution to seizure control.~      Our preliminary research now suggests that there may be a healthy, long-term dietary~     approach to controlling seizures.~      Based on our animal work and published clinical studies the investigators hypothesize that a~     DHA dose of 3 g/day will reduce seizure frequency in patients with intractable seizures.~   "
98399|NCT01769079|"~     Chronic treatment of stable angina with nitrates long and short action is extremely~     frequent. In clinical practice the most commonly observed is a combination of anti-anginal~     agents, usually including nitrates fixed in an attempt to improve the quality of life of~     patients, which is not always met with success.~      Numerous questions and problems are seen with chronic use of oral nitrates. From a practical~     standpoint, some advocate the withdrawal of medication in stable patients, while many~     physicians still hesitate to withdraw the medication by the lack of definitive information~     about its consequences. In this sense there is a rationale for the attempted removal of~     nitrate fixed these patients, although evidence to support this action have not been~     adequately evaluated.~   "
98400|NCT01769066|"~     The aim of this study is to explore the Clinical Value of Sequential Gefitinib With~     Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.~   "
98401|NCT01769053|"~     In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was~     introduced, which is able to increase the variability of the respiratory pattern independent~     from the inspiratory effort. In experimental lung injury, variable PSV was found to improve~     gas exchange and decrease the inspiratory effort, while reducing alveolar edema and~     inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable~     PSV reduced peak airway pressure and respiratory system elastance in a variability dependent~     manner.In addition, preliminary observations suggest that variable PSV can reduce the work~     of breathing and improve patient comfort, but it is not known whether this new ventilatory~     strategy is able to speed the weaning from mechanical ventilation.~      Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction~     of pressure support and, therefore, a shorter weaning period than conventional PSV.~      The hypothesis of this study is that variable pressure support ventilation reduces the~     duration of mechanical ventilation to non-variable (conventional) pressure support~     ventilation.~   "
98428|NCT01768702|"~     Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to~     standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.~   "
98402|NCT01769040|"~     This investigational trial will be assessing the effect of rifaximin on pathophysiology and~     haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on~     several organs on marker level. The molecular and physiological effects of rifaximin will be~     explored.~      The investigators hypothesize that intestinal decontamination with rifaximin in patients~     with cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the~     following inflammatory response, prevent splanchnic vasodilatation and portal systemic~     contraction and thereby reduce the risk clinical complications to cirrhosis.~      If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement~     in liver haemodynamics, renal function and systemic dynamics, then these effects may~     contribute to the overall well-being of the patient and prevent complications to the~     underlying cirrhosis such as risk of infections, progression of disease, and admission to~     hospital.~   "
98403|NCT01769027|"~     An increasing body of evidence indicates that an immune basis might underline a number of~     pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had~     Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic~     streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric~     autoimmune neuropsychiatric disorders associated with streptococcal infections. More~     recently, several PANDAS variants have been described, including adult-onset variant. There~     are many evidences that OCD/tic symptoms could be due to an immunologic reaction against~     brain tissues following a streptococcal infection.~      The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to~     improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or~     azithromycin in case of penicillin allergy) is more effective than SSRI only.~      Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin~     (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment~     response is based on the lack of a Y-BOCS score improvement of at least 35%).~      Objectives:~        -  To determine the safety and efficacy of SSRI+AB compared to SSRI only.~        -  To test the safety and additional beneficial effects of high dose of IVIG on antibiotic~          prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.~      Study methodology:~        -  Participants will be screened to obtain medical history and other information at~          Neurologic and Psychiatric Sciences Department of Florence University Hospital and at~          Paris-est University.~        -  Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks~          (double-blind randomized trial)~        -  Patients who will not respond to AB will be admitted to the hospital to receive IVIG~          for 5 days, for 5 consecutive months.~        -  Follow-up visits will take place 3 and 6 months after the first evaluation, followed by~          6 months follow-ups for 3 additional years.~      Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional~     echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both~     before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG~     treatment.~   "
98404|NCT01769014|"~     It is the goal of this study adherence and quality of life in a population of people~     suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are~     influenced by treatment, support, social services, and residential treatment. The study~     population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.~   "
98405|NCT01769001|"~     Patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0~     mg/kg), to receive the same dose they had received in Phase 1/2 study PB-102-F01, and will~     continue to receive PRX-102 as an intravenous infusion every 2 weeks for 38 weeks.~   "
98406|NCT01768988|"~     This is a randomized, double blind controlled, parallel arms trial, aimed to assess the~     efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study~     include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing~     the presence of central sensitization and its potential reversion by Pregabalin; (3)~     assessing quality of life of patients treated with pregabalin in comparison to placebo; (4)~     to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5)~     to compare anxiety and depression in patients treated with pregabalin in comparison to~     placebo.~   "
98407|NCT01768975|"~     The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in~     subjects with moderate to severe pain associated with osteoarthritis of the knee following~     cessation of pain therapy.~   "
98408|NCT01768962|"~     To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2~     weeks of daily rectal use and after 2 weeks of daily vaginal use~   "
98409|NCT01768949|"~     The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring~     the right ventricle can predict the inefficacy and/or the unsafeness of recruitment~     maneuvers in patients suffering from acute respiratory distress syndrome~   "
98410|NCT01768936|"~     Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after~     initial operative focus elimination to investigate the PCT ratio's impact on decision-making~     for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic~     peritonitis.~   "
98411|NCT01768923|"~     To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011~     American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition~     of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints~     [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.~      To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis~   "
98412|NCT01768910|"~     The purpose of this study is to provide profound insight into the supraspinal neuronal~     mechanisms and networks responsible for lower urinary tract (LUT) control and to verify,~     amend or adjust neuronal circuitry models established from findings in healthy subjects in~     the context of neurogenic and non-neurogenic LUT dysfunction.~   "
98413|NCT01768897|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together~     with cytarabine and mitoxantrone hydrochloride in treating patients with relapsed or~     refractory acute myeloid leukemia. Drugs used in chemotherapy, such as CPI-613, cytarabine~     and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. CPI-613 may help cytarabine~     and mitoxantrone hydrochloride work better by making cancer cells more sensitive to the~     drugs~   "
98414|NCT01768884|"~     Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability~     of Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa~     Bronchiolitis is defined as an infection of the small airways. It is also the most common~     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the~     leading cause of global child mortality. NO has been shown to play a critical role in~     various biological functions, including the vasodilatation of smooth muscle,~     neurotransmission, regulation of wound healing and immune responses to infection such as~     microbicidal action directed toward various organisms. NO in the airways is considered to~     play a key role in the innate immune system in which the first-line of host defense against~     microbes is built.~      It has shown the beneficial effect of NO in different diseases with several options of doses~     and regimens - from newborn with primary pulmonary hypertension which showed improvement in~     oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult~     respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at~     18 and 36 ppm.~      In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part~     per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a~     wide variety of phyla including bacteria, viruses, helminthes and parasites.~      Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month~     old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment~     in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO~     intermittent inhalation treatment compared to standard treatment in 2-12 months old~     bronchiolitis subjects.~      Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2~     -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized~     into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition~     to standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the~     standard treatment for 5 days.~      Treatment administration: Treatment blindness will be kept by separating between unblinded~     team members (giving the actual treatment) and blinded team members, and by hiding the NO~     container and all study related equipment behind a curtain. Between study inhalations the~     subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO ,~     nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be~     continuously monitored.~      All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted~     on day 30 (+5) from day of admission to the department.~      End of study treatment (both groups) will be assessed by a blinded study physician base on~     clinical assessment. Subject improvement that will lead to end study treatment = clinical~     score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from~     the hospital.~   "
98415|NCT01768871|"~     The primary objective of this study is to evaluate the function of the knee after a total~     knee replacement with the VEGA system®.~   "
98416|NCT01768858|"~     The main purpose of this study is to assess patients` adherence attitudes (beliefs) to the~     maintenance therapy with a scheduled Adalimumab monotherapy or a combination therapy with~     methotrexate and to investigate whether there are correlations between such beliefs and~     adherence to maintenance treatment.~   "
98451|NCT01768403|"~     Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose~     of this study is to establish the proportion of patients on lipid-lowering pharmacological~     treatment reaching the LDL-C goals according to the Third Joint European Task Force~     guidelines in the survey population.~   "
98417|NCT01768845|"~     Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical~     cord that can restore the bone marrow) transplant can be a curative therapy for the~     treatment of hematologic malignancies (a disease of the bone marrow and lymph nodes). The~     source of cells used for the transplant comes from related (sibling) and in cases where~     there is no sibling match, from unrelated donors through the National Marrow Donor Program.~     The availability of a suitable donor can be a significant obstacle for patients who need a~     transplant but do not have a matched donor. Cord blood that has been harvested from an~     umbilical cord shortly after birth has a rich supply of cells needed for transplant. These~     stored cord bloods are now being used to transplant adults without a matched donor~      Advantages to using cord blood includes a readily available source of cells with no risk to~     the donor during the collection process, immediate source of cells in urgent situations (no~     lengthy donor work-up)and a reduction in infectious disease transmission to the recipient.~      One of the main disadvantages is the cord blood has a small number of cells needed for~     transplant. In an adult, usually two cords are needed and large recipients do not qualify~     because they need too many cells.~      This study will use two different preparative regimens (chemotherapy and radiation) followed~     by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the~     physician and is based on patient's age, disease and medical condition at the time of~     transplant.~      Multiple objectives for this study include disease-free and overall survival, treatment~     related mortality, rate of cells taking hold, and the incidence and severity of the~     transplant complication called graft versus host disease (GVHD).~   "
98418|NCT01768832|"~     Parkinson disease (PD) is characterized by substantial disability and reduced quality of~     life, both of which can be attributed in large part to difficulties with walking. Evidence~     suggests that exercise may be an important addition to traditional treatments, particularly~     with respect to addressing walking problems. In particular, dance and treadmill training~     have been individually shown to improve walking performance and quality of life. At present~     it is not clear whether dance or treadmill training have similar effects or if one is~     superior to the other. Furthermore, our understanding of the means by which these exercise~     interventions convey benefits is extremely limited. This study aims to address these~     knowledge gaps by directly comparing dance, treadmill training and stretching (control~     group). The primary area of interest is the effects on gait, with secondary measures of~     disease severity, balance, and quality of life. The investigators will determine not only~     the effects of the interventions on walking performance, but will also investigate the~     effects of the interventions on connections between different parts of the brain and on~     brain function during imagined walking tasks using functional magnetic resonance imaging~     (fMRI). Participants will be randomly assigned to dance, treadmill training, or a~     stretching/flexibility control group. Participants will be assessed over a period of 6~     months at 3 different time points. The investigators hypothesize that both dance and~     treadmill training will lead to improvements in forward walking, but that dance will result~     in greater improvements in backward walking compared to treadmill training. Furthermore, the~     investigators hypothesize that the tango and treadmill interventions will have different~     effects of brain function and brain connections. The investigators expect dance to enhance~     the activity and connections of particular brain regions and treadmill training to enhance~     activity and connections of different brain regions. The investigators do not expect changes~     in brain activity or connections in the control group.~   "
98419|NCT01768819|"~     Although some authors have observed favorable effects of group physical activity programs,~     others have reported that the individualized prescription of exercises may be jeopardized by~     programs that do not allow sufficient consideration of individual characteristics.~     Therefore, we aim to verify the effects of an elderly-specific multimodal physical activity~     program on physical parameters after one year of intervention.~   "
98420|NCT01768806|"~     This study is a large, multi-site, randomized controlled NIH trial that evaluates whether~     The P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY~     Project Home Consultation model coaches parents, through monthly home visits and the use of~     video feedback, to effectively interact with their young child with autism. The aims of the~     study are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that~     caregivers can be taught to interact in an engaging way with their child (with causing more~     stress), 3.) that the child then interacts better, improves his/her language, and has~     reduced severity of his or her autism.~   "
98421|NCT01768793|"~     This project will test a novel lifestyle intervention to help overweight and obese~     socioeconomically disadvantaged African American women achieve healthy weight control during~     and after pregnancy and improve the health of their offspring. The treatment will be given~     through an existing national home visiting program, Parents As Teachers (PAT), which will~     facilitate sustainability and nationwide dissemination, if effective. We hypothesize that~     compared with standard PAT monitoring and counseling (PAT), women randomized to the~     lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of~     Medicine recommendations for gestational weight gain.~   "
98422|NCT01768780|"~     Various methods are used to assess the level of anesthesia block after spinal anesthesia.~     Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting,~     but ice is limited by difficulties with management and transportation, and needle assessment~     has problems owing to the risk of pain, infection, and injury to the patient.~      Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more~     important in the surgical process, and assessing the pain block level is more feasible in~     practice than assessing the sensory nerve block level using the alcohol swab.~      Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate~     assessment of the pain block level. This has the advantage of continuous measurement of the~     block level, which can be used in a practical manner in conjunction with the surgical~     incision.~      Hence, the author compared the conventional method using the alcohol swab with the use of~     the peripheral nerve stimulator to determine which method is more practical in the~     measurement of spinal anesthesia block level.~   "
98423|NCT01768767|"~     This study is looking at the safety and efficacy of combined ketamine and lithium therapy~     for treating patients with bipolar depression who are taking a mood stabilizer that is not~     working for them.~   "
98424|NCT01768754|"~     A growing body of evidence suggests that in individuals with chronic lung disease their walk~     speed is related to their daily function and quality of life. It is possible to assess their~     usual (routine) and fast walking speeds by getting them to walk in a flat hallway.~      In individuals with chronic lung disease, we anticipate that their usual walk speed will be~     helpful in exercise prescription and use in multidimensional scoring systems. However, it is~     important to first determine the measurement properties of these two walk speeds.~   "
98425|NCT01768741|"~     The purpose of this study is to investigate the clinical value of laparoscopic liver~     resection in the treatment of hepatocellular carcinoma by assessing its Surgical and~     oncologic outcomes comparing with open liver resection.~   "
98426|NCT01768728|"~     The purpose of this study is to investigate the influence of the laparoscopic and open left~     hemihepatectomy on acute surgical trauma and stress response.~   "
98429|NCT01768689|"~     Adherence to tyrosine kinase inhibitors is associated with improved outcomes in chronic~     myeloid leukemia patients. Hence, improved adherence might improve CML patients' prognosis.~      Decreased adherence is a common problem in such patients, with non-adherence in up to 30% of~     patients in several studies. Recently, an emphasis has been placed on improving patient's~     adherence to tyrosine kinase inhibitors in these patients. However, there is no prospective~     high-quality evidence showing that adherence can be improved in these patients.~      Therefore, the investigators hypothesize that adherence-encouraging interventions improve~     adherence to tyrosine kinase inhibitors in chronic myeloid leukemia patients.~   "
98430|NCT01768676|"~     The purpose of this study is to determine whether avanafil will affect different aspects of~     sperm production.~   "
98431|NCT01768663|"~     The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin,~     itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with~     ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with~     ivacaftor on lung function.~   "
98432|NCT01768650|"~     This study seeks to compare two different behavioral treatments for pain in Veterans with a~     history of TBI. Both treatments involve educating the Veteran about pain, discussing the~     impact of pain, and different ways to manage it in hopes of decreasing pain and its impact~     on life. These approaches are called self-management approaches to pain. Both of these~     treatments are commonly used in pain clinics to treat pain in persons with back pain,~     headaches, and other types of chronic pain. The investigators will be delivering both~     treatments over the telephone to make the treatments accessible to Veterans wherever they~     live.~   "
98433|NCT01768637|"~     Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are~     more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor~     inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular~     events. Clinical practice guidelines are ambiguous about the use of these agents in Chronic~     Kidney Disease due to lack of controlled studies. The investigators hypothesize that~     patients with Chronic Kidney Disease compared with non-Chronic Kidney Disease have reduced~     platelet aggregation and poor platelet inhibitory response to aspirin. The aims are to 1)~     define the range of whole blood platelet aggregation in stages 3-5 Chronic Kidney Disease~     patients; 2) investigate whether patients with stages 4-5 Chronic Kidney Disease vs.~     non-Chronic Kidney Disease have lower platelet aggregation or impaired von Willebrand Factor~     activity; and 3) compare inhibition of platelet aggregation from baseline after 2 weeks of~     aspirin therapy and another 2 weeks of clopidogrel therapy added to aspirin in Chronic~     Kidney Disease vs. non-Chronic Kidney Disease patients. Accomplishing these aims will~     provide pilot data to power future studies of targeted anti-platelet agent treatments in~     Chronic Kidney Disease in order to improve cardiovascular outcomes.~   "
98434|NCT01768624|"~     The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up~     Study are to determine the proportions of patients, identified in the 2009 PINOT cohort~     that:~      (i)Made the transition to home dialysis, after an initial start on center-based dialysis.~      (ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed~     plans for conservative care.~      The hypotheses to be tested in the PINOT follow-up study are:~        1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not~          commence home dialysis within 3 years, and instead remain on centre-based~          haemodialysis; and,~        2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care~          commence dialysis within 3 years.~   "
98435|NCT01768611|"~     Cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of~     high extracellular glucose resulting in intracellular activation of deleterious biochemical~     pathways. Expression of GLUT-1, the major glucose transporter in mesangial cells, is~     increased and participates in the induction of diabetic nephropathy. Variants in the gene~     encoding GLUT-1 (SLC2A1) have been associated to this diabetic complication. The aim of this~     study was to test whether polymorphisms in SLC2A1 confer susceptibility to diabetic~     nephropathy in Brazilian type 1 diabetes patients.~   "
98436|NCT01768598|"~     Boys suffer a disproportionately large number of fractures compared to girls (55-60%). This~     study aims to determine why this is the case by identifying risk factors for wrist~     fractures. The increase in fracture during childhood and adolescence may be associated with~     1) risk-taking behaviour in boys, 2) obesity trends in boys during childhood and~     adolescence, and/or 3) impaired acquisition of bone strength during childhood and~     adolescence. Importantly from a knowledge translation perspective, modifiable factors such~     as behaviour, dietary habits or physical activity in boys may predict fracture.~      The investigators will measure 400 children (100 girls and 100 boys who have sustained a~     fracture; 100 same age and sex friends) across 4 years of growth. This study will assess~     risk behaviours, diet, physical activity, motor proficiency (i.e., balance and~     coordination), fat and muscle mass and bone strength to determine if there are, 1)~     differences in whether all or some of these factors predict fractures in boys compared with~     girls and, 2) whether these factors track forward similarly in boys compared with girls as~     children advance through the growth spurt.~   "
98437|NCT01768585|"~     This study investigates whether chronic heart rate reduction with ivabradine (Procoralan®,~     Servier, France) affects aortic compliance and endothelial function in patients with chronic~     stable coronary artery disease.~   "
98438|NCT01768572|"~     Primary Objective:~      To assess, in the same study, the safety of sarilumab and tocilizumab in patients with~     rheumatoid arthritis (RA) who are inadequate responders to or intolerant of tumor necrosis~     factor (TNF) antagonists.~   "
98439|NCT01768559|"~     Primary Objective:~      - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin~     (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not~     adequately controlled on insulin glargine ± metformin.~      Secondary Objectives:~      - To compare the treatments/regimens on:~        -  The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,~        -  Body weight,~        -  Self-Monitored Glucose profiles,~        -  Fasting Plasma Glucose (FPG),~        -  Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test~          (subset of participants),~        -  Daily doses of insulins,~        -  Safety and tolerability.~   "
99470|NCT01755104|"~     The purpose of the study is to evaluate the impact of the intake of a dietary supplement~     STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic~     syndrome.~   "
98440|NCT01768546|"~     Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases~     in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when~     the body becomes resistant to the hormone insulin. Insulin resistance results from weight~     gain and physical inactivity, making the vast majority of new cases of type 2 diabetes~     preventable with lifestyle changes.~      After the findings of the Diabetes Prevention Program were released in 2002, the high cost~     of the lifestyle program prevented it from becoming widely adopted throughout the U.S.~      The UnitedHealth Center for Health Reform and Modernization (CHRM) will evaluate the use and~     effectiveness of a scalable approach for providing lifestyle-based diabetes prevention~     intervention through Comcast's XFINITY Video-On-Demand (VOD) programming, with additional~     non-compulsory support from SparkPeopleTM (Cincinnati, Ohio), an interactive tracking and~     problem solving web portal. By design, this effort will engage adult television viewers and~     offer them education and resources to support their efforts to achieve levels of weight loss~     and physical activity which have previously shown to prevent the development of type 2~     diabetes. Specifically, we aim to evaluate:~        1. Viewing patterns and characteristics of consumers accessing a prevention program via~          VOD~        2. Effectiveness in terms of weight loss achieved~        3. Consumers' ratings of overall content~   "
98441|NCT01768533|"~     The goal of this study is to do formative research which will lead ultimately to the~     development of a computer-based system called Tailored Information for Diet and Exercise or~     TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in~     children. The system will be used by physicians and parents/primary care givers in pediatric~     primary care practices with the aim of improving parent-pediatrician interactions related to~     counseling and anticipatory guidance on energy balance behaviors. The aim of this study is~     to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent~     of the child in the waiting room and assesses topic areas related to energy balance~     behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors~     questionnaire (EBB-Q). This will require focus groups, cognitive testing of the~     questionnaire, and survey administration.~   "
98442|NCT01768520|"~     This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap.~     arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in~     patients with osteoarthritis of knee.~   "
98443|NCT01768507|"~     Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to~     evaluate the HO-1 stimulation of resveratrol in healthy humans.~   "
98444|NCT01768494|"~     Patients presenting to the emergency department (ED) currently face inacceptable delays in~     initial treatment, and long and costly hospital stays due to suboptimal initial triage.~     Accurate ED triage should focus not only on initial treatment priority, but also on~     prediction of medical risk and nursing needs to improve site of care decision and to~     simplify early discharge management. Herein, we propose a large prospective cohort study to~     optimize initial patient triage for (a) better determination of initial treatment priority,~     (b) overall risk and need for inhospital treatment and (c) early assessment of post-acute~     nursing needs.~   "
98445|NCT01768481|"~     Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary~     outcome is intima media thickness before and after intervention.~   "
98446|NCT01768468|"~     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet~     and Joins tablet in the treatment of osteoarthritis of the knee.~   "
98447|NCT01768455|"~     The objective of the study was to investigate the pharmacokinetic drug interaction between~     gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly~     and each alone.~   "
98448|NCT01768442|"~     The investigators' goal is to incorporate advanced imaging information into the treatment~     planning process and assess response in tumor, nodes and non-cancerous tissues in head and~     neck cancer patients during and after concurrent chemotherapy and radiation therapy~     (chemoRT) via biophysical, biochemical and vascular imaging using magnetic resonance imaging~     (MRI). The investigators will recruit 30 patients with locally advanced head and neck cancer~     into the study. All patients will obtain an advanced MRI study at three time points: 1)~     before the start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months~     following completion of chemoRT. MRI scans will include a) T1, T2 and T2* imaging, b)~     vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure~     images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic~     imaging. The subject's response (tumor, nodes and salivary and mucosal tissues) will be~     evaluated using clinical outcomes. Correlations will be generated between the parameters~     obtained from MR images and from clinical response assessments.~      The purpose of this study is to assess whether advanced MR imaging techniques can be used to~     determine tumor and node response (i) four weeks following initiation of concurrent chemoRT~     and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced~     MR imaging techniques can be used to predict early at-risk organ function (salivary gland~     and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation~     therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion~     of chemoRT in head and neck cancer.~   "
98449|NCT01768429|"~     The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself~     differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum~     inflammatory markers. Lipidomic profiles and gene expression will be used for thorough~     assessment of the possible clinical changes. The study will compare the effects of~     alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The~     results of this project will help to identify the optimal source of n-3 fatty acids, and~     reveal the significance of the components of fish other than fatty acids. These data will be~     useful both nationally and internationally, since highly controlled dietary interventions~     utilizing new methodology are scarce.~   "
98450|NCT01768416|"~     The purpose of this study is to use the BIS monitor to assess the degree of consciousness in~     pre-terminal palliative patients admitted to our palliative care unit and to ascertain if~     this tool provides a more accurate assessment of consciousness in this specific group of~     patients than clinical observation of consciousness and the use of sedation scales.~      We hypothesize that the measured BIS results provide a more accurate assessment of the~     patient's level of consciousness than routine clinical observation or the use of sedation~     scales.~   "
98452|NCT01768390|"~     AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride~     dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed~     orthodontic appliances (FOA).~      The null hypothesis is that neither incidence nor severity of lesions would differ from a~     control group using standard fluoride dentifrice.~      SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4~     Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000~     ppm fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for~     inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected~     duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their~     teeth during 2 minutes twice daily during the entire period of treatment. Before bonding,~     and after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the~     maxillary incisors, canines and premolars are taken. At debonding, remaining composite~     material on the surfaces is removed with a slow rotating carbide bur followed by polishing~     with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is~     thereafter exposed.~      The primary outcome measure is the incidence and severity of WSL as registered separately by~     two blinded experienced and calibrated clinicians according to a validated index. A random~     sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The~     intervention is indended run throughout the full duration of the orthodontic treatment,~     varying between 18 and 24 months.~   "
98453|NCT01768377|"~     The purpose of this study is to compare intubation with nerve block with intubation with~     sedation in awake patients in terms of efficacy, ease, and the rate of complications and~     physician satisfaction~   "
98454|NCT01768364|"~     Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents~     cystoscopically after stone surgery?~   "
98455|NCT01768351|"~     Current activated Vitamin D therapies are approved for treating secondary~     hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data~     in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several~     studies show that the benefits are greater with the newer vitamin D analog paricalcitol when~     compared with calcitriol. A large gap exists in our knowledge between epidemiological~     studies in human that demonstrate improved outcomes with vitamin D use and observations in~     preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the~     provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to~     determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in~     anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this~     effect not only reflects the hyperparathyroidism correction, but is also dependent on the~     direct effects of paricalcitol on erythroid progenitor cells.~   "
98456|NCT01768338|"~     The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see~     what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.~   "
98457|NCT01768325|"~     The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing~     it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious~     disorder.~      This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently~     approved by the U.S. Food and Drug Administration (FDA) for use.~   "
98458|NCT01768312|"~     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic~     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12~     weeks after treatment, each treatment group comparisons for evaluation of efficacy and~     safety in Moderate to Severe Dry Eye Disease.~      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),~     Non-anesthetic Schirmer test~   "
98459|NCT01768299|"~     A double-blind randomized controlled trial to compare a shorter interval between the~     administration of mifepristone and misoprostol (simultaneous administration compared to~     24hours from administration of mifepristone to receipt of the first dose of misoprostol) for~     termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that~     a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst~     reducing the duration of the procedure and in turn, the duration of hospitalization.~   "
98460|NCT01768286|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV)~     administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1~     hepatitis C virus (HCV) infection.~   "
98461|NCT01768273|"~     The purpose of this study is to determine the safety and tolerability of PA-824 when given~     with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a~     clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of~     midazolam, a known CYP3A substrate.~   "
98462|NCT01768260|"~     Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function~     by improving the blood perfusion of eyes. The present study aims to investigate the effect~     of EECP on Anterior Ischemic Optic Neuropathy.~   "
98463|NCT01768247|"~     A thin endometrium is one of the most difficult problems encountered in assisted~     reproduction every day practice Regarding the proliferative phase, several ways of treatment~     have been undertaken to circumvent thin endometrium trying to increase thickness with~     questionable results.~      The objective of the current study will be whether a daily dose of 150 IU (international~     units) of human chorionic gonadotropin (HCG) for seven days concomitant with estrogen~     administration in estrogen replacement cycles can increase the endometrial thickness and~     improve pregnancy outcome.~   "
98476|NCT01768078|"~     One useful effect of early intravitreal corticotherapy is to diminish inflammatory~     complications after endophthalmitis, which may cause, at least in part, serious~     complications (retinal detachment, macular edema) which are, more than the infection, causes~     of the complications seen after acute endophthalmitis.~   "
98477|NCT01768065|"~     This study will evaluate effectiveness and adherence of the nasal expiratory positive airway~     pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea~     Syndrome (OSAS). NEPAP is currently approved for use only in adults.~   "
98504|NCT01767714|"~     The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only])~     plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6~     CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus~     placebo.~   "
98464|NCT01768234|"~     There is a large body of evidence from adult populations suggesting cognition in adults is~     affected by hydration status. The few studies conducted in the global North in populations~     of schoolchildren indicate that drinking water has an impact on pupil performance on basic~     cognitive tasks. No studies assessing the impact of dehydration and cognition in~     schoolchildren have been carried out in the global South, where access to water is the~     poorest and dehydration prevalence is likely higher. This study will examine the effect of~     drinking supplementary water during the school day on hydration status and on cognitive test~     scores in schoolchildren in Mali, West Africa.~      The investigators hypothesize that providing supplemental water will result in a decrease in~     prevalence of dehydration in the study group and will result in an improved performance on~     cognitive test scores.~      Data will be collected from up to four purposively-selected schools in the Sikasso region of~     Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be~     eligible for recruitment. Research staff will explain the study to pupils at the school and~     individually request informed oral assent for participation. A waiver of parental consent~     for pupil interviews will be secured from the Ministry of Education. At each school, school~     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the~     pupil participants.~      Children that assent to participate in the study will be randomly allocated to the~     intervention or control group. Data collection will take place at each school over two days~     within a one-week period, with one study group tested on each of the two days. On the~     intervention testing day, all study participants will receive supplementary water. On the~     control testing day, no study participants will receive supplementary water. Testing~     procedures in both groups is identical and will include a five-minute interview, two~     cognitive testing sessions of 45 minutes each, and collection of two urine samples during~     the day. None of these activities collect personal data or identifiers, and the urine sample~     will not be stored.~      All data collection will occur at the school and will be conducted by trained local~     enumerators. There are no risks to participation other than a small amount of class time~     missed by pupils, and great efforts will be made to minimize time outside of class.~   "
98465|NCT01768221|"~     This one-arm pilot study will evaluate the feasibility and acceptability of Caregiver~     Outlook, a manualized chaplain-led intervention to improve the well-being of caregivers of~     seriously ill patients.~      Study Activities and Population Group:~      The investigators anticipate enrolling 36 informal caregivers (adults) through DUMC~     providers and/or self-referral. Potential subjects will be screened for study eligibility,~     consented if eligible and interested, and one week later administered a baseline survey by~     phone. Next, the chaplain-led intervention will be delivered by phone in three one-hour~     sessions, spanning a one month window. After session 3, subjects will receive a check-in~     phone call to briefly discuss their any additional thoughts, questions or concerns they may~     have. Sessions will be audio recorded. After intervention completion, follow-up surveys will~     be administered by phone at two points in time.~      Data Analysis and Risk/Safety Issues:~      This is a mixed-methods study involving qualitative thematic analysis and survey data,~     collected from the adult caregiver subjects. There are no known physical risks to~     participation, and the study team will work to ensure confidentiality and data~     safety/integrity.~   "
98466|NCT01768208|"~     This study is an open-label, cohort study to evaluate the potential mechanisms of~     Saxagliptin in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive~     metabolomic method, in combination with fingerprint analysis and target analysis. It is a~     sub-study of STUDY: D168L00008.~   "
98467|NCT01768195|"~     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg~     Positive lymphoma patients treated with rituximab-based immunochemotherapy.~   "
98468|NCT01768182|"~     Objective: HIV infected individuals present a cluster of conditions that activate or injure~     the vascular endothelium. The administration of folates may exert beneficial effects on~     endothelial function in different populations at risk for cardiovascular disease. The aim of~     the study was to determine the effects of 4 weeks folinic acid supplementation on forearm~     vascular responses during reactive hyperemia in HIV-infected people under antiretroviral~     therapy.~      Methods: This was a prospective, randomized, double-blind, placebo-controlled trial to~     compare the effects of 4 weeks daily ingestion of 5 mg folinic acid (n=15) or placebo~     (n=15). Participants had to be on anti-retroviral therapy for at least 6 months before~     enrollment, with undetectable viral load, and CD4 cell count > 200 cells/mm3. Vascular~     function was evaluated with venous occlusion plethysmography at baseline and after 4 weeks,~     for the determination of brachial artery reactive hyperemia, and after isosorbide dinitrate~     administration~   "
98469|NCT01768169|"~     Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low~     fat plant-based diet will contribute to decelerating further escalation of the epidemics~     of obesity, the (pre)metabolic syndrome, and T2DM in Taiwan.~   "
98470|NCT01768156|"~     HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may~     have an advantage over the CA-125 assay in that it is less frequently positive in patients~     with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of~     ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up~     period after treatment in metastatic ovarian cancer should be studied. It could be used in~     patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be~     compared with information provided by CA-125. The kinetics of HE4 values after treatment~     should be also analysed to determine the role that HE4 could play in the detection of~     recurrences during the follow-up of metastatic patients.~   "
98471|NCT01768143|"~     To measure competencies in propofol sedation for endoscopic procedures (NAPS)through~     development, test and validation of a reliable assessment tool in a simulator setting.~      Hypothesis: That the tool will demonstrate content and construct validity, ie. enable~     reliable measuring of necessary competencies of different levels in a reproducible way.~   "
98472|NCT01768130|"~     The study will investigate the test-retest variability of thermal thresholds in patients~     with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal~     roller delineated an area with cool sensory dysfunction on the painful site. In this area~     and in a contralateral area as a control, 5 sites were outlined, including the point of~     maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection~     threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory~     testing. Tests were repeated after a 4-6 weeks interval.~   "
98473|NCT01768117|"~     This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086~     vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6~     schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work~     directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086~     vaccine development program. The study will provide descriptive safety and immunogenicity~     data following vaccination of these individuals with bivalent rLP2086 vaccine.~   "
98474|NCT01768104|"~     The purpose of this study is to determine the efficacy and safety of endoscopic submucosal~     tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the~     treatment of upper gastrointestinal submucosal tumors.~   "
98475|NCT01768091|"~     The purpose of this study is to determine the efficacy and safety of peroral endoscopic~     myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.~   "
98478|NCT01768052|"~     The investigators plan to use optical brain imaging technology to observe patients with~     current major depression before, during, and after repetitive Transcranial Magnetic~     Stimulation (rTMS) clinical treatment. Clinical treatment involves 20-30 rTMS sessions over~     the course of 4-6 weeks.~      Our primary hypotheses are as follows:~        1. Primary Hypothesis: In patients with a positive response to rTMS, the investigators~          will observe an increase in the strength of connectivity as measured by fMRI among~          brain regions in the cognitive control network after 4 weeks of treatment.~        2. Secondary Hypothesis: Brain activation measured by functional Near-Infrared~          Spectroscopy(fNIRS) in the dorso-lateral prefrontal cortex (DLPFC) during rTMS will~          increase as the number of treatments increase. Detection of this increase in brain~          activity at the beginning of the treatment help researchers and physicians assess~          treatment response.~   "
98479|NCT01768039|"~     Two hundred and forty patients with multiple sclerosis who met the study criteria will be~     enrolled in this randomized double blind placebo-controlled clinical trial.~      They will randomly assigned to placebo or vitamin D treatment group. The total time of study~     is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU)~     vitamin D, while the other group will receive weekly placebo. The annual relapse rate and~     EDSS will be compared at baseline, month 6 and 12.~   "
98480|NCT01768026|"~     The objective of this study is to characterize the extent and severity of disease in~     subjects with DEB and the progression of disease over a timeframe relevant to interventional~     studies. The data from this study will be used to inform the study design and address~     statistical considerations of future treatment protocols.~   "
98481|NCT01768013|"~     The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in~     Japanese subjects with extensive psoriasis vulgaris.~   "
98482|NCT01768000|"~     The purpose of this study is to examine the effectiveness of family cognitive adaptation~     training, including its impact on functioning and caregiver burden. Families that receive~     the manual will be compared with a control group of families that will not receive the~     manual. The larger goal is to add to the tools family members have access to better support~     their family members with schizophrenia.~   "
98483|NCT01767987|"~     The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker~     release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).~   "
98484|NCT01767974|"~     Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be~     performed. The detection rates of EGFR mutation will be compared using paired samples.~   "
98485|NCT01767961|"~     This pilot clinical trial studies the modified barium swallow in measuring swallowing~     function after surgery in patients with oropharyngeal cancer who have undergone surgery. New~     diagnostic procedures, such as the modified barium swallow, may be effective in studying the~     side effects of cancer therapy in patients who received treatment for oropharyngeal cancer~   "
98486|NCT01767948|"~     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations~     change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic~     impairment.~   "
98487|NCT01767935|"~     This pilot clinical trial studies cryosurgery and radiation therapy in treating patients~     with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation~     therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink~     tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells~   "
98488|NCT01767922|"~     Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact~     and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived~     stress, physical and intellectual fatigue, pain perception, if present, and the impact on~     the quality of life of 70 subjects included with 60 that can be evaluated.~   "
98489|NCT01767909|"~     An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can~     arrest or reverse the disease at its earliest stages. The emotional and financial burden of~     AD to patients, family members, and society is enormous, and is predicted to grow~     exponentially as the median population age increases. Current FDA-approved therapies are~     modestly effective at best. This study will examine a novel therapeutic approach using~     intranasal insulin (INI) that has shown promise in short-term clinical trials. If~     successful, information gained from the study has the potential to move INI forward rapidly~     as a therapy for AD. The study will also provide evidence for the mechanisms through which~     INI may produce benefits by examining key cerebral spinal fluid (CSF) biomarkers and~     hippocampal/entorhinal atrophy. These results will have considerable clinical and scientific~     significance, and provide therapeutically-relevant knowledge about insulin's effects on AD~     pathophysiology. Growing evidence has shown that insulin carries out multiple functions in~     the brain, and that insulin dysregulation may contribute to AD pathogenesis.~      This study will examine the effects of intranasally-administered insulin on cognition,~     entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in~     amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12~     months of treatment with INI compared to placebo, subjects will improve performance on a~     global measure of cognition, on a memory composite and on daily function. In addition to the~     examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to~     examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4)~     allele carriage predict treatment response.~      In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months,~     following an open-label period of 6 months where all participants will be given active drug.~     The study uses insulin as a therapeutic agent and intranasal administration focusing on nose~     to brain transport as a mode of delivery.~   "
98490|NCT01767896|"~     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture~     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine~     (TIV) in elderly subjects.~   "
98501|NCT01767753|"~     Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in~     early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently~     during the nocturnal period than during the diurnal period in a group of medically-treated~     patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT~     effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the~     24-hour effect of SLT in untreated glaucoma patients.~      The purpose of this study is to assess the changes of IOP over a 24-hour period in patients~     with glaucoma undergoing SLT.~   "
98502|NCT01767740|"~     The primary objective of this study is to obtain safety data on the use of the ULTRABRAID~     PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS~     SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff repair.~   "
98505|NCT01767701|"~     The purpose of this study is to determine whether raltegravir is effective in preventing~     progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced~     MRI.~   "
98491|NCT01767883|"~     Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary~     care offices and primary care physicians are generally not familiar with treatment~     guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently~     associated with co-morbidities that make effective treatment difficult due to complexity of~     care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective,~     evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality~     improvement and other interventions such as CDS plus practice facilitation may be needed.~      Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based~     guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice~     guidelines that PCPs may use to enhance the care they provide to a difficult to manage~     segment of the healthcare population.~      Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE~     model of practice change, versus CDS alone. The study aims to analyze differences in~     promoting evidence-based care in primary care practices. Thirty-six practices will be~     recruited for this study. Patient inclusion criteria: adult patients with estimated~     Glomerular Filtration Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing~     over three or more months. A process evaluation will be conducted between the CDS practices~     with facilitation and the CDS only practices to assess clinical outcomes of CKD progression~     and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit~     ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to~     cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01~     mechanism starting on 07/01/2011 and ending on 06/30/2016.~   "
98492|NCT01767870|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal~     immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced~     colorectal neoplasia compared to colonoscopy.~   "
98493|NCT01767857|"~     The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix~     (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to~     standard therapy.~   "
98494|NCT01767844|"~     Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In~     healthy individuals, food supplementation with creatine (Cr) increases muscle size and~     improves physical function and quality of life. The aim of this study is to investigate~     whether RA patients may benefit similarly.~      50 participants will be given a food supplement to take for 12 weeks; this supplement will~     either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).~      Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness~     (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will~     be tested. In addition, quality of life questionnaires will be completed, disease activity~     will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be~     obtained, from those who volunteer to provide them, at baseline and post-treatment.~   "
98495|NCT01767831|"~     This study combines data collection and simulation-based education, and it will enroll up to~     36 adults with T1DM who already have experience with insulin pump therapy and some~     experience with a continuous glucose monitor (CGM). The study will first track participants~     for of a 3-day CGM-training period. The training period will be followed by a 1-week CGM~     monitoring and CGM data collection period. Following the 1-week CGM monitoring-only portion~     of the study, participants will begin the education intervention component of the study,~     referred to as Insight-Based Online Learning Using Simulation and Education for Diabetes~     (iBOLUSED). The education intervention component is 4 weeks in length. The intervention will~     involve daily diary data upload and daily simulation-based feedback based on the collected~     diary data. During the first week (and for up to 2 weeks) of the intervention, participants~     will view glycemic outcome data that represents the participant's hypo- and hyperglycemic~     risk throughout the day, based on the CGM data collected during the CGM monitoring period.~     In the next 2 weeks of the intervention, participants will have an opportunity to interact~     with the internet-based system using a simulation-based tool designed to provide insight to~     the participant regarding the different effects of modifications to insulin therapy.~     Throughout the educational intervention, participants will record diary data every day~     through the use of a diary component in the internet-based system. Diary entries include~     data on meals, physical activity, history of the insulin basal rate and insulin boluses~     given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if~     applicable, menstrual cycle and any physical illness. Participants will also upload data~     from the CGM via the Dexcom Data Manager 3 (DM3) software or the Dexcom Studio Software. Two~     assessments, one prior to the intervention period and one following the intervention, will~     be administered to gather relevant psychobehavioral information. Focus group sessions will~     be conducted at the end of the study, which will allow for the collection of information~     regarding the effectiveness of the Internet intervention and will provide insight for the~     design of future studies. Parallel recording of CGM, insulin, and behavioral data, as well~     as psychometric instruments, will produce a rich synchronized data set for each person that~     will facilitate the development of personalized behavioral profiles that will be employed to~     provide individualized feedback to educate participants. In particular, this study tests the~     use of collected diary data to educate participants by describing glucose profile~     information and presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones~     throughout the day, (2) insulin meal bolus information and associated glycemic outcome~     indices, and (3) basal rate information with associated glycemic outcome indices.~   "
98496|NCT01767818|"~     The primary objective of this study is to obtain detailed clinical information and biologic~     specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD.~     Because of the inherent difficulties of using clinical outcome measures to assess disease~     modification, the identification of biomarkers of PD is of paramount importance. The ideal~     PD biomarker would be one that is easily assayed in a convenient biological sample, varies~     proportionally with disease severity, is abnormal during the pre-symptomatic phase of the~     illness, and is unaffected by drugs or other interventions used to treat PD. The existence~     of a sensitive biomarker with these properties would enable much more effective disease~     modifying research that would likely be able to take advantage of smaller and potentially~     shorter trials.~   "
98497|NCT01767805|"~     The purpose of this study is to compare different culture conditions. The effect of the type~     of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5%~     versus 20%) will be evaluated on the embryo quality~   "
98498|NCT01767792|"~     To determine the hearing response rate at 24 weeks after treatment with bevacizumab for~     symptomatic vestibular schwannomas (VS) in children and young adults with NF2.~   "
98499|NCT01767779|"~     To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients~     that will develop infantile spasms/epilepsy in the near future and thus are appropriate~     candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop~     epilepsy, it would be useful to have a biomarker that could predict those patients destined~     to have epilepsy and thus identify those TSC patients most appropriate for an~     antiepileptogenic drug trial. A recent study suggests that treating TSC patients with an~     abnormal EEG prior to onset of infantile spasms with vigabatrin may improve neurological~     outcome, but the use of EEG as a reliable biomarker of future epilepsy has not been~     rigorously validated. In this specific aim, we will test the reliability of EEG in~     predicting future development of infantile spasms or epilepsy in TSC patients during the~     first year of life.~   "
98500|NCT01767766|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in~     patients with advanced hematologic malignancies.~   "
98503|NCT01767727|"~     Multiple finger defects are common in hand trauma and result in functional disability. These~     injuries are often complex and severe, and thus reconstructive alternatives are limited. In~     this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the~     digital artery, for reconstruction of multiple finger defects. At the final follow-up, we~     would evaluate the efficacy of this technique.~   "
98506|NCT01767688|"~     This study will investigate and compare the pharmacokinetics of a single 25-mg dose of~     MK-3102 in participants with moderate hepatic impairment and matched healthy participants.~     The primary hypothesis is that in participants with moderately impaired hepatic function,~     the area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar~     to that observed in healthy matched control participants following a single 25 mg oral dose~     of MK-3102. Specifically, the true ratio (moderately impaired hepatic function~     patients/healthy matched control subjects) of geometric means for AUC0-∞ is no greater than~     2.~   "
98507|NCT01767675|"~     The purpose of this study is to see if the investigators can improve the treatment of this~     type of cancer. They want to find out what effects, good and/or bad, giving heated~     chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has~     on the patient and this type of cancer.~      The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of~     chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to~     get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and~     Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary~     peritoneal cancer.~   "
98508|NCT01767662|"~     The purpose of this study is to determine effectiveness of parents' manipulation in newborn~     with talipes calcaneovalgus over observation group.~   "
98509|NCT01767649|"~     The purpose of this study is to identify molecules produced specifically by the cells from~     the chorionic membranes of the materno-fetal interface (the water bag) sign for the~     activation of preterm labor.~   "
98510|NCT01767636|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     kidney cancer that has spread to other places in the body (metastatic). Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking~     blood flow to the tumor.~   "
98511|NCT01767623|"~     This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the~     pharmacokinetics and safety of vemurafenib in patients with BRAF V600 mutation positive~     cancer. Patients will receive vemurafenib 960 mg (normal hepatic function) or 720 mg (severe~     hepatic impairment) orally twice daily on Days 1 to 20 (morning dose) and from Day 27~     onwards until disease progression or inacceptable toxicity occurs.~   "
98512|NCT01767610|"~     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to~     evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic~     characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized~     fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong~     Wae Pharm. through 3 period by separately or combinedly.~   "
98513|NCT01767597|"~     With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year,~     hepatitis B is currently a frequent and potentially severe disease in France, despite~     efforts towards prevention and effective care.~      In terms of prevention, France has very low immunization coverage (27.7%) and a high~     percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly~     explained by poor knowledge of hepatitis B infection in the general population and an~     underestimation of the health impact of hepatitis B by doctors and health officials. Until~     recently, there have been no national guidelines governing its implementation (which is~     variable depending on the structures where screening is performed) and an insufficient~     evaluation of screening practices. Thus, data on the severity of liver disease, indications~     for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized~     people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely,~     particularly to address the issue of people who do not come back and collect their results~     and to better adapt counselling, their usefulness to detect of hepatitis B virus has not~     been evaluated to date.~      The main objective of the Optiscreen B Study is to determine the benefit, if any, of using~     rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B.~     Individuals risk of HBV-infection will be randomized into 2 groups, one group for which~     screening will be performed by usual serological test and a second group for which screening~     will be based on rapid tests. Centers will be selected to represent a diverse range of~     health centers whose aims include screening, prevention and/or vaccination.~   "
98514|NCT01767584|"~     The objective of this study was to confirm if two formulations of cephalexin tablets are~     bioequivalent.~      Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1~     g Cephalexin; Eli Lilly). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-40~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
98515|NCT01767571|"~     The objective of this study was to confirm if two formulations of cephalexin suspension are~     bioequivalent.~      Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product~     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for~     Ceporex and 20 ml of suspension for Keflex® .~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
98516|NCT01767558|"~     PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post~     market clinical study conducted in Europe. The purpose of the study is to evaluate~     asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial~     fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.~   "
98548|NCT01767142|"~     Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a~     belt applicator. Applicator design and treatment parameters will be evaluated.~   "
98927|NCT01762202|"~     Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined~     with ofatumumab (FCO2) in previously untreated young patients with Chronic Lymphocytic~     Leukemia (CLL).~   "
98517|NCT01767545|"~     To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with~     bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is~     treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive~     bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with~     dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly~     intervals. The primary endpoint was BCVA at twelve months.~   "
98518|NCT01767532|"~     The objective of this study was to confirm if two formulations of cephalexin suspension are~     bioequivalent.~      Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product~     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
98519|NCT01767519|"~     A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with~     overactive bladder (OAB) and urinary incontinence.~   "
98520|NCT01767506|"~     Infection with C. Trachomatis has decreased substantially in trachoma endemic areas~     following repeated annual mass drug administration (MDA) with azithromycin, although not as~     rapidly as anticipated. The investigators propose to conduct a clinical trial in 52~     communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The~     investigators plan that all communities would have annual rounds of MDA if infection is~     greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a~     surveillance and treatment program to identify and treat new families and families who~     travel after mass treatment. Communities will have MDA stopped if infection is 1% or less,~     or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The~     proportion of communities that are able to stop mass treatment will be compared in the group~     of communities randomized to mass treatment plus the newcomer/traveler treatment program~     compared to the communities randomized to mass treatment alone after 24 months.~      At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty~     eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18~     months will be surveyed at 30 months. At risk of trachoma re-infection communities have C.~     trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month~     survey. Surveillance of communities for families that meet the newcomer or traveler status~     will extend 6 months beyond the 24 month survey to 30 months in the intervention communities~     only. A survey of sentinel children in the intervention and control communities at 30 months~     will be conducted to assess the level of trachoma and infection in all 38 communities at~     risk of trachoma re-emergence.~   "
98521|NCT01767493|"~     The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron~     emission tomography (PET) for assessment of demyelination in the patients with relapsing~     remitting multiple sclerosis.~   "
98522|NCT01767480|"~     Robot-assisted training (RT) devices developed to date have a significant impact on stroke~     rehabilitation. Several research groups have developed the robotic devices and examined~     their efficacy on improving upper limb function after stroke. All these robotic devices have~     been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific~     evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the~     impact on physiological responses is still lacking.~      This trial is to examine (1) the immediate effects of treatment intensity in RT on~     sensorimotor impairments and functional performance in patients with subacute stroke; (2)~     the long-term benefits of treatment intensity in RT by conducting a 6-month follow up~     evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the~     physiological markers of inflammation, oxidative stress, and erythrocyte deformability.~     These overall findings will help better understanding of the efficacy of RT on functional~     outcomes, brain and movement reorganization, and physiological markers.~   "
98523|NCT01767467|"~     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'~     vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will~     evaluate safety-related events and antibody and cellular immune responses to the study~     vaccine, as compared to placebo.~   "
98524|NCT01767454|"~     This is an open-label, multi-center, dose-finding Phase 1 study that will enroll subjects at~     least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations. The~     primary objective of the study is to describe the safety for the doublet therapy (dabrafenib~     and ipilimumab) and the triplet therapy (dabrafenib/trametinib and ipilimumab). Preliminary~     efficacy data will also be collected. Subjects will be assigned to receive either the~     doublet combination (dabrafenib and ipilimumab) or the triplet combination (dabrafenib,~     trametinib, and ipilimumab). Subjects will be enrolled to dose-finding cohorts in the~     doublet combination (dabrafenib + ipilimumab) in a sequential 3+3 fashion. Following~     establishment of a dose for the doublet combination, an expansion cohort will be opened. At~     the same time, enrollment to dose finding cohorts for the triplet combination (dabrafenib +~     trametinib + ipilimumab) will begin in a sequential 6+6 fashion. Enrollment into triplet~     cohorts will take priority when both the doublet expansion arm and the triplet dose-finding~     arm are open for enrollment at the same time. Approximately 9-24 subjects will be enrolled~     to the dose finding portion of the study. Approximately 30 subjects will be enrolled to~     doublet expansion cohort and 30 subjects will be enrolled in the triplet expansion cohort. A~     two-week run-in period without ipilimumab will be followed by 4 intravenous doses of~     ipilimumab at the recommended dose and schedule. Oral daily dosing of dabrafenib or~     dabrafenib + trametinib will continue from the two-week run-in, through combination with~     ipilimumab, and post-ipilimumab until no longer of clinical benefit, in the opinion of the~     treating physician, or until unacceptable AE or death~   "
98549|NCT01767129|"~     To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg~     dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of~     levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).~   "
99471|NCT01755091|"~     This is a proof of concept study to determine the safety and efficacy of dronabinol for the~     treatment of obstructive sleep apnea syndrome (OSA).~   "
98525|NCT01767441|"~     Bariatric surgery can lead to improvement or even resolution of type 2 diabetes Mellitus~     (T2DM) with the spectrum of responses depending also on operation procedures. However, many~     mechanisms of metabolic action of different surgical techniques still are unclear.~      The aim of this study is to provide a better understanding of the effects of three types of~     bariatric surgery (lap banding, gastric bypass and sleeve gastrectomy) on beta-cell function~     and incretin secretion. A mixed meal tolerance (MMT) test will be performed before and 1 and~     12 months after surgery to assess beta cell adequacy and glucagon-like-peptide-1~     (GLP1)/glucose-dependent insulinotropic polypeptide (GIP) bioavailability.~   "
98526|NCT01767428|"~     A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast~     release in fasted state.~   "
98527|NCT01767415|"~     The purpose of this study is to investigate whether stereotactic indigo carmine injection~     can safely increase the extent of tumor resection.~   "
98528|NCT01767402|"~     The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the~     GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy~     elderly population aged 18-45 years of age.~   "
98529|NCT01767389|"~     This study will assess the utilization patterns (adherence, source of the index antidiabetic~     agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1)~     receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors~     (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute~     pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors,~     separately, in comparison to other ADAs.~      The proposed study will help in understanding the treatment utilization patterns and the~     incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists.~     This study differs from previous observational studies by including both exenatide and~     liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).~      This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters)~     commercial health insurance database from 2005-2011.~   "
98530|NCT01767376|"~     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the~     meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of~     the two vaccines given separately in healthy adolescents and young adults.~   "
98531|NCT01767363|"~     This retrospective cohort study will assess the association of benign prostatic hyperplasia~     (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the~     occurrence of prostate cancer related mortality. This study will also assess a number of~     secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and~     all cause mortality.~   "
98532|NCT01767350|"~     The long-term success of solid organ transplantation is largely dependent on the efficacy of~     immunosuppressive medication. Unfortunately, for the most important agents the correct drug~     levels are difficult to attain, with potential severe consequences of drug under- or~     overexposure. In addition there is a large variation in dose requirements within and between~     different subjects. Clinical studies have demonstrated that a better control of drug~     exposure can improve outcome. A large set of patient characteristics appear important in~     determining dose requirements in adults, in particular genetic variation in genes involved~     in drug metabolism. In children relative dose requirements are increased compared to adults,~     but is not known why and the role of pharmacogenetic variation has not been described.~      Our study aims to describe relative dose requirements in children after solid organ~     transplantation with the help of clinical and laboratory data obtained during regular~     hospital visits (retrospective). In addition we will assess their genotype for genes~     involved in the metabolism of immunosuppressives.~   "
98533|NCT01767337|"~     This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of~     saline from the FLUGEN 101.2 investigational microneedle-based device.~   "
98534|NCT01767324|"~     The goal of this exploratory study is to select the optimal body site for intracutaneous~     delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.~   "
98535|NCT01767311|"~     This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study~     using a Bayesian design with response adaptive randomization across placebo or 5 active arms~     of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using~     a composite clinical score (ADCOMS). BAN2401-G000-201 is an 18-month study in which 3 dose~     levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of~     participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of~     participants. Participants will be from 2 clinical subgroups: mild cognitive impairment~     (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim~     analyses will be conducted to continually update randomization allocation on the basis of~     the primary clinical endpoint.~   "
98536|NCT01767298|"~     This study was conducted to compare the rate and extent of absorption of valsartan and~     hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose~     of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).~   "
98537|NCT01767285|"~     The investigators are examining if there is a difference in continuation rates of the~     etonogestrel contraceptive implant between women who have the device placed immediately~     after delivery, before leaving the hospital, and women who have the device placed at the~     routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio,~     for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks~     after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to~     complete a brief survey. The investigators hypothesize that continuation rates of Implanon~     will be higher in the immediate postpartum placement arm than in the delayed placement arm.~   "
98538|NCT01767272|"~     The present study was adopted to evaluate the pharmacokinetics and dose linearity of~     fexofenadine after oral administration.~   "
98539|NCT01767259|"~     This study was conducted to compare the rate and extent of absorption of valsartan and~     hydrochlorothiazide following oral administration as a fixed dose combination tablet and~     concomitant administration of the individual drugs under fasting conditions in healthy~     Egyptian subjects. The study was extended to investigate any potential reaction between VAL~     and HCT.~   "
100299|NCT01744275|"~     This a multi-center study to examine whether supplementation with omega 3 fatty acids will~     reduce seizure frequency in patients with epilepsy .~   "
98540|NCT01767246|"~     Patients who are diagnosed with Patellofemoral Pain Syndrome (PFS) and present to our clinic~     will be offered the opportunity to participate in the study. If they consent to be in this~     study they will randomized into 2 treatment groups. The experimental treatment group will be~     treated according to the novel PFS treatment algorithm. The control group will receive~     treatment that would be considered standard physical therapy care. To apply standard~     physical therapy care in a standardized manner the investigators are using a multimodal~     treatment approach that has been previously shown by Lowry to be beneficial in the treatment~     of PFS. Both groups of subjects will be seen 2 times per week for a maximum of 12 visits.~     Patients can be discharged early if they no longer report pain or impaired function on the~     Anterior Knee Pain scale.~      The purpose of this study is to see if patients with patellofemoral pain syndrome treated~     with the experimental Patellofemoral treatment algorithm experience significant improvements~     in function, pain and the number of treatment sessions compared with a previously researched~     multimodal approach to the treatment of patellofemoral pain.~      The secondary objective of this study is to examine results to determine if a full~     randomized controlled clinical trial of the PFS algorithm is justified.~      The investigators hypothesize that utilization of the Patellofemoral syndrome treatment~     algorithm with evaluation and treatment of patients diagnosed with PFS will lead to~     significant improvements in function, pain and the number of treatment sessions when~     compared to previously researched treatment of PFS.~   "
98541|NCT01767233|"~     Since the majority of patients with necrotizing pancreatitis will experience a leak from the~     pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid~     collections, it is reasonable to hypothesize that placement of a ductal stent may prevent~     some of the late complications and morbidity associated with pancreatic necrosis. This~     prospective, randomized, controlled multicenter trial investigates the role of early~     prophylactic ductal stenting in acute necrotizing pancreatitis.~      The purpose of the study is to determinate the safety and feasibility of early prophylactic~     pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of~     stay in hospital and in in-tensive care unit compared to the traditional treatment.~   "
98542|NCT01767220|"~     A significant portion of patients with cardiac diseases like coronary artery disease (CAD),~     dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC)~     develops ventricular tachycardia (VT). The standard ablation procedure is carried out from~     endocardial only. In 30% of patients treated this way a successful ablation is not possible.~     In these cases the scar areas are mostly located in the outer layer of the myocardium.~     Ablation is feasible only if the catheter is placed in the epicardial space to reach the~     surface of the heart muscle. In the past this type of ablation was performed as a second~     procedure in case of recurrent VTs after unsuccessful endocardial ablation.~      This prospective randomized trial compares the standard ablation procedure (endocardial~     ablation only) with a new strategy. This means in a single procedure the scar areas~     responsible for VT are marked and obliterated from endocardial as well as from epicardial.~     The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation~     only.~      40 patients will be enrolled. They will be randomized 1:1 in the study arms strategy 1~     which is standard endocardial ablation and strategy 2 which is endo- and epicardial~     ablation.~      At least 12 months are planned for enrollment. The study is closed if the patient last~     enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12~     months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted~     cardioverter defibrillator) interrogation.~      Both ablation strategies are well established and conducted with standard equipment. The~     methodology of this study does not contain any experimental approaches. The standard~     insurance coverage of the hospital is guaranteed for all enrolled patients.~   "
98543|NCT01767207|"~     Patients referred to pediatric rehabilitation services have often cognitive~     deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when~     designing treatment plans.~      Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a~     high risk of developing mental health problems. There is lack of knowledge about such~     comorbid mental disorders in the health service. There are also few validated instruments~     for assessing mental disorders among children and adolescents with cognitive deficits and ID~     both in Norway and abroad.~      The main aims of the current multicentre study are to:~      Investigate psychometric properties of different psychiatric instruments for children and~     adolescents. Investigate change and stability of symptoms over time. Investigate user~     satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in~     Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use~     information from parents, teachers and patients, in addition to clinician-rated measures.~     Patients will be assessed at intake and after six months. We have conducted a pilot study in~     the period from 2012 to 2013.~   "
98544|NCT01767194|"~     This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide~     with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that~     has returned or does not respond to treatment. Drugs used in chemotherapy, such as~     irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor~     cells and help kill them or carry tumor-killing substances to them. It is not yet known~     whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or~     dinutuximab is more effective in treating neuroblastoma.~   "
98545|NCT01767181|"~     EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to~     investigate the effects of 12 weeks of randomized timed light therapy or timed physical~     exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral~     circadian rhythms and cardiometabolic function in healthy night shift workers.~   "
98546|NCT01767168|"~     The purpose of this study is to test the hypothesis that a preoperative test of pain~     modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a~     risk score for the prediction of persistent pain will be developed from parameters available~     before surgery.~   "
98547|NCT01767155|"~     Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy~     and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with~     endometrial cancer resistant to platinum/taxane-based chemotherapy.~   "
98550|NCT01767116|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without~     cirrhosis.~   "
98551|NCT01767103|"~     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the~     effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide~     metabolite following a single oral dose of 33mg/kg Ferriprox®.~   "
98552|NCT01767090|"~     The main objective for this study is to assess the efficacy and dose-response relationship~     of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives~     are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response~     relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in~     reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.~   "
98553|NCT01767077|"~     Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on~     blood lipid profile, vascular function, insulin sensitivity, inflammation and gene~     expression. Overweight subjects will be randomized to one of 2 groups with different types~     of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).~   "
98554|NCT01767064|"~     Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists~     despite decades of intervention efforts. Negative outcomes of inappropriate antibiotics~     include increased costs of care, adverse drug reactions, and rising prevalence of~     antibiotic-resistant bacteria. To address this public health problem, we apply the~     principles of commitment and consistency in an effort to influence clinician decision-making~     through the implementation of a low-cost behavioral nudge in the form of a simple public~     commitment device. Clinicians were asked to post in their exam room a signed letter~     indicating their commitments to reducing inappropriate antibiotic use for ARIs. Our~     hypothesis is that clinicians displaying the poster-sized commitment letters will decrease~     their inappropriate antibiotic prescribing for ARIs as compared to clinicians in the control~     condition (with no posted letter).~   "
98555|NCT01767051|"~     Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous~     clinical presentation varying throughout life, from birth up to post-menopause. Although~     mostly known for its reproductive consequences, PCOS is associated with metabolic~     abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are~     considered to be at risk for early insulin resistance, leading to development of PCOS and~     metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are~     considered as states of low- and pro-inflammation associated with endothelial dysfunction.~     In addition, it has been shown that endothelial dysfunction develops from the first decade~     of life in response to genetic and environmental risk factors. Therefore, offspring of women~     with PCOS may be at increased risk for vascular disease later in life. Moreover, some~     evidence suggests that early life respiratory disease also contributes to later life~     cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a~     systematic follow up of children born form PCOS mothers has not been performed yet. the~     investigators propose a systematic evaluation of cardiometabolic and pulmonary health~     characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A~     saliva sample will be performed to determine the biochemical androgenic status of the~     children. Mothers of these children have undergone standardized phenotyping prior to~     conception; the investigators will therefore be able to correlate the metabolic status of~     the mother around the time of conception and the cardiometabolic and pulmonary health of~     their offspring.~   "
98556|NCT01767038|"~     Patients with retinal detachment do not always recover good visual function. Sometimes~     simple causes are responsible. Other causes can only be discovered thanks to high-resolution~     imaging provided by the latest generation of OCT.~      This study is possible thanks to surgical teams who have a strong recruitment potential,~     with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude~     FRIENDS) to define more strict intervention criteria. The principal objective of this study~     is to better define with regard to time:~        -  The onset of surgically curable or transient macular affections, and losses in visual~          acuity that can be qualified as explained~        -  But above all to better understand the relationships between anatomical analyses~          obtained using OCT and autofluorescence and functional analysis using visual acuity and~          microperimetry.~        -  In the near future, two techniques (OCT and microperimetry) will certainly become~          essential tools in the evaluation of macular function. Better understanding of these~          relationships is the first necessary step in any study concerning the therapeutic~          prevention of retinal lesions related to retinal detachment: This study will make it~          possible to define criteria for the evaluation of anatomical and functional recovery,~          their relationship with each other and finally their evolution over time. This is an~          essential first phase before possible therapies can be evaluated.~   "
98557|NCT01767025|"~     In this study, the influence of oxytocin on automatic imitation behaviour is investigated.~     Healthy adults will be administered with either oxytocin or a placebo, and will perform an~     imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the~     specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be~     presented.~   "
98558|NCT01767012|"~     Modern phacoemulsification techniques have made cataract surgery safe and efficient over the~     past several decades. Although the phacoemulsification procedure has improved greatly,~     cataract surgery still involves trauma. One of the surgical traumas during cataract surgery~     is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of~     the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous~     barrier (a measure of the uveal reaction) clinically presents as flare in the anterior~     chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may~     mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this~     flare and cell intensity in the anterior chamber was shown to be reached during the first~     two days after cataract surgery 4 and flare levels were back to the preoperative values~     about one year after cataract surgery. 5, 6 Influencing factors are surgical technique 7,~     perioperative treatment 8, IOL biomaterial and design 9 and host reaction to the IOL.~      In this study the otherwise same IOL concerning material and design, but one with a new~     surface modification will be compared to assess the influence on aqueous flare and cell~     intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a~     hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface~     and a novel modified surface.~      To assess the efficacy of the newly modified surface of the Polylens IOL compared to the~     same IOL without a modified surface concerning flare and cell intensity in the anterior~     chamber as well as cellular components on the IOL surface and lens epithelial out-growth~     from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and~     pseudoexfoliation syndrome, which typically have a higher incidence of post-operative~     intra-ocular inflammation.~   "
98559|NCT01766999|"~     Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic~     surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with~     large volumes of a solution which also contain local anesthetics. However local anesthetics,~     can also lead to a marked production of methemoglobin. New generation pulse oximeters are~     able to measure SpMetHb non-invasivly.~      The aim of this study is:~        1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at~          increased risk for methemoglobinemia.~        2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction~          employing tumescent anesthesia has been carried out.~   "
98560|NCT01766986|"~     Background: Owing to controversial staging and classification of adenocarcinoma of the~     oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach~     remains problematic.~      In a retrospective study, preoperative staging of AOG and the impact of preoperative~     misclassification on outcome were analysed. Methods: Data from patients with AOG were~     analysed from a prospectively collected database with regard to surgical treatment,~     preoperative and postoperative staging, and outcome.~   "
98561|NCT01766973|"~     Recent evidence suggests that chronic pain is associated with abnormal connectivity between~     brain regions associated with the processing of pain. We aim to test the diagnostic power of~     resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic~     back pain. Using new methods of image acquisition and analysis we aim to develop a~     computational method to correctly classify patients and matched control subjects.~   "
98562|NCT01766960|"~     One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD).~     NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people~     have this disease, the change in how the liver handles drugs and compounds in the body has~     not been studied. The purpose of this study is to investigate how advanced NAFLD changes the~     ability of the liver to handle both endogenous and exogenous compounds.~   "
98563|NCT01766947|"~     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous~     humor via the trabecular meshwork through the Schlemm's canal towards the systemic~     circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose~     of glaucoma management is to lower IOP in order to prevent progression of the optic~     neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering~     drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses~     despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating~     surgical procedure for the treatment of open angle glaucoma that allows the enhancement of~     the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular~     meshwork. DS was shown to achieve a good control on IOP over the long term.~      The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with~     Triggerfish in patients with POAG before and after DS.~   "
98564|NCT01766934|"~     Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy~     unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.~   "
98565|NCT01766921|"~     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived~     influenza vaccine in elderly subjects~   "
98566|NCT01766908|"~     This is an experimental research study for pregnant women between 23 and 37 weeks age of~     gestation who will be having a baby sooner than term. This study is to learn if waiting 20,~     40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her~     outcome and overall health. Benefit to the baby may come by increasing the amount of blood~     in the baby's body, reducing the need for possible transfusion later, and possible~     prevention of other complications caused by too little blood in the baby. Possible reduction~     of cerebral palsy may be realized by a longer interval for cord clamping.~   "
98567|NCT01766895|"~     The linkage between viral hepatitis and renal failure is complex. The current study aims to~     exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan~   "
98568|NCT01766882|"~     The purpose of this study to conduct a pilot, randomized trial in stable HD patients to~     evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight,~     combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure~     on hydration/volume status and blood pressure (BP) control.~   "
98569|NCT01766869|"~     The investigators' goal is to develop a non-selective and non-invasive procedure to identify~     aggressive tumors and simultaneously identify their exact location in Prostate cancer~     patients undergoing radical prostatectomy by combining multiparametric MRI and machine~     learning techniques. The combination of multi-parametric MRI and machine learning (validated~     using histopathology) can lead to increased sensitivity and specificity of cancer foci in~     the prostate, and help in isolating aggressive from indolent tumors. This increased~     sensitivity and specificity may eventually lead to: a) a reduction in the number of patients~     that undergo unnecessary treatment, and b) enhance current treatment options by enabling the~     use of focused therapies. The investigators will recruit 15 patients with prostate cancer~     that are currently scheduled to undergo radical prostatectomy into the study. All patients~     will obtain an advanced MRI study prior to the radical prostatectomy. MRI scans will include~     a) high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images~     using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using~     diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging.~     Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based~     on standard of care (Gleason grading system). Correlations will be generated between the~     parameters obtained from scans and from clinical assessments.~   "
98580|NCT01766726|"~     The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have~     increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated~     QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and~     c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction~     as a mechanism of improved plaque inflammation/vulnerability. Parameters of lipid and immune~     function will also be assessed in healthy control subjects, for comparison.~   "
98606|NCT01766375|"~     This study was a multi-center, open, randomized-control study on the effects and safety of~     idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on~     the overall survival rate and disease-free survival rate of acute myeloid leukemia patient~     in high-risk group over a period of 2 years.~   "
98570|NCT01766856|"~     This study will determine whether the likely success of closing a hole in the eardrum can be~     predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that~     connects the back of the nose with the middle ear. When a person goes up in an airplane and~     their ears pop or when one yawns and their ears pop, that is the Eustachian tube~     opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear~     the same as in the environment and keeping the middle ear free of fluid. It is thought that~     in children with middle-ear disease, the muscles that open the Eustachian tube do not work~     very well; this seems to get better in many children as they get older. It is thought that~     poor Eustachian tube function is the cause of failures when holes in the eardrum are patched~     and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to~     see whether it can be predicted, based on testing Eustachian tube function before surgery,~     whether patching the eardrum will be successful and whether fluid will come back in the ear~     after it is patched.~   "
98571|NCT01766843|"~     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler~     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.~   "
98572|NCT01766830|"~     Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the~     availability of good diagnostic capacities, undifferentiated febrile illnesses continue to~     be a thorny problem for travel physicians. In developing countries, the scarcity of skilled~     personnel and adequate laboratory facilities makes the differential diagnosis of fevers even~     more complex. Health care workers must often rely on syndrome-oriented empirical approaches~     to treatment and might overestimate or underestimate the likelihood of certain diseases. For~     instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of~     persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and~     major disability. These diseases are however rarely diagnosed at primary health care (PHC)~     level. The difficulty in establishing the cause of febrile illnesses has resulted in~     omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost~     and development of drug resistance.~      In resource-limited settings, clinical algorithms constitute a valuable aid to health~     workers, as they facilitate the therapeutic decision in the absence of good laboratory~     capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of~     NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain~     empirical. Besides, they rarely take into account local prevalence data, do not adequately~     represent the spectrum of patients and differential diagnosis at the primary care level and~     often have not been properly validated. The purpose of the study is to develop~     evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with~     persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia~     and Nepal.~   "
98573|NCT01766817|"~     The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once~     daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in~     forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary~     fibrosis (IPF).~   "
98574|NCT01766804|"~     The aim of the present study is to evaluate the ability a colostrum containing diet to limit~     gastrointestinal toxicity including chemotherapy induced inflammation in children treated~     for acute lymphoblastic leukemia.~   "
98575|NCT01766791|"~     A plethora of trials reported the positive effect of resistance exercise on functional and~     morphological parameters. Although a large amount of the studies used suboptimum devices and~     obsolete methods the results of these older studies were still considered as golden~     standard. The aim of the present study is thus to determine the proper effect of different~     resistance exercise protocols with and without adjuvant protein supplementation on~     functional and morphological muscle and body composition parameters in male untrained~     subjects 30-50 years old under special regard of modern medical imaging and segmentation~     technologies.~      Our general study hypothesis is that HIT-resistance exercise significantly impact relevant~     muscular parameters of the upper leg.~   "
98576|NCT01766778|"~     The purpose of this study is to observe change of HbA1c over time from baseline to month 12.~     The ultimate goal of this study is to provide a local reference value to the physicians &~     patients in the future when they consider initiating Vildagliptin and taking balance between~     efficacy, compliance, risk factors, convenience and medication cost.~   "
98577|NCT01766765|"~     Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time~     to AC is associated with worse survival. However, most clinical trials mandate that AC is~     still to commence within 6 to 8 weeks after surgery consideration for malnutrition,~     postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube~     for enteral nutrition is a common component of these procedures, as a result of superior~     postoperative organ function, decreased infection rates, and a greater likelihood to~     complete AC with enteral nutritional support.~      Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing~     morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital~     stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in~     reductions in total complications compared with traditional postoperative feeding practices~     and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube~     routine placement and combination with FTS is still being debated. Besides, there remains~     some controversy over the optimal combination of nutrients and duration and timing and~     routes of feed administration.~      The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN)~     following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and~     minimizes time to AC when compared with FTS with early oral nutrition (EON).~   "
98578|NCT01766752|"~     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic~     management in non-critically ill patients with type 2 diabetes at the general ward~   "
98579|NCT01766739|"~     The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different~     dose levels. The investigators want to find out what effects, good and/or bad, it has on the~     patient and the malignant pleural effusion. A malignant pleural effusion is a build up of~     fluid in the chest cavity cause by the cancer.~   "
98605|NCT01766388|"~     The primary goal of this study is to examine the efficacy and feasibility of a mifepristone~     combined with misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in~     Armenia.~   "
98581|NCT01766713|"~     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from~     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver~     disease that can lead to cirrhosis and liver-related mortality in persons who drink little~     or no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this~     spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation~     with or without fibrosis. The etiology of NASH is not completely understood, but it is often~     associated with obesity, type 2 diabetes, hyperlipidemia and insulin resistance.~     Lipotoxicity, insulin resistance and oxidative stress appear to be central to the~     pathogenesis of NASH. Currently, there is no FDA approved treatment for NAFLD/NASH. Weight~     loss and exercise are the recommended but often difficult maintain these lifestyle changes~     in the long term and therefore therapeutic agents have been investigated. Ezetimibe is an~     LDL lowering agent that works through inhibition of the fat absorption from the small~     intestine. In this study, we propose to treat 50 patients with NASH with either Ezetimibe or~     placebo for 24 weeks. After an initial evaluation for insulin sensitivity, MRI liver fat~     distribution and liver biopsy, patients will receive either 10 mg/day of Ezetimibe or~     placebo. Patients will be monitored at regular intervals for symptoms of liver disease, side~     effects of Ezetimibe and serum biochemical and metabolic indices. At the end of 24-weeks,~     patients will have a repeat medical evaluation, liver MRI and liver biopsy. Pre and post~     treatment MRI-derived liver fat content, liver histology and insulin sensitivity will be~     compared. The primary end point of successful therapy will be improvement in hepatic~     steatosis measured by MRI. Secondary end points will be improvement in insulin sensitivity,~     liver histology and liver biochemistry.~   "
98582|NCT01766700|"~     The no calorie drink study is looking for over 300 people to participate. The study is~     evaluating the effect of no calorie beverages on weight loss and weight maintained over time~     in people who drink diet beverages every day as compared to water only drinkers during the 1~     year study period.~   "
98583|NCT01766687|"~     The investigators have designed a randomized controlled trial to test whether increased~     water intake slows renal decline in patients with Stage-III Chronic Kidney Disease.~     Participants randomized to the hydration-intervention group will be asked to drink 1.0 to~     1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for~     one year. The investigators will calculate the change in kidney function (estimated~     glomerular filtration rate, measured every three months for 12 months), and compare renal~     decline between the intervention and control groups. The investigators hypothesize that~     increased water intake will slow renal decline.~   "
98584|NCT01766674|"~     This is a randomized, controlled trial among 100 total males and females with hyperkyphosis,~     aged 60 years and older, to determine the effects of an exercise intervention that includes~     high intensity spinal muscle strengthening exercises compared to a usual care waitlist~     group.~   "
98585|NCT01766661|"~     The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait~     procedure in comparison to the standard surgery for low rectal cancer. The investigators~     compare quality of life, faecal incontinence and recurrence of neoplasm in patients who~     received standard colo-anal anastomosis with protective ileostomy or two-staged~     Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.~   "
98586|NCT01766648|"~     To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in~     Closed Distal Femur Fractures in adults when compared to standard locking screw constructs.~      Fracture healing at 3 months will be assessed via x-ray and clinical assessment of the~     fracture.~      Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation~     between subjects treated with far cortical locking screw or standard locking screw fixation.~   "
98587|NCT01766622|"~     Background:~      - 18F-CP18 is a chemical designed for use in imaging studies. It is attracted to tumor cells~     that are being killed by cancer treatment. Researchers want to test it in imaging studies~     for people who are being treated with Birinapant. Birinapant is a drug used to treat~     advanced ovarian, fallopian tube, or peritoneal cancers. It works kills tumor cells that~     have not responded to earlier treatment. 18F-CP18 may help to monitor cancer treatments with~     this drug.~      Objectives:~      - To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with~     Birinapant.~      Eligibility:~      - Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian~     tube, or peritoneal cancer.~      Design:~        -  Participants will have a brief physical exam. They will also answer questions about~          their medical history and any current medications.~        -  Participants will receive a dose of 18F-CP18, followed by an imaging study. The study~          will involve a positron emission tomography/computed tomography (PET/CT) scan. The scan~          will last 40 minutes.~        -  There will be two more PET/CT scans 1 hour and 2 hours after taking 18F-CP18. These~          scans will look at how the tumor cells absorb and process 18F-CP18.~        -  This is a scanning study only. No treatment will be provided as part of this study.~   "
98588|NCT01766609|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. It has a major psychosocial impact on affected patients. There~     are many treatment modalities available for vitiligo, however, none of them cure the~     disease. Topical corticosteroids (CS) are the most effective monotherapy for localized~     vitiligo. Treatment with intralesional corticosteroids (ILCS) is commonly used in many~     dermatologic conditions. However, there are only a few studies published on the use of ILCS~     in vitiligo. This is a prospective double-blind randomized clinical trial to assess efficacy~     and safety of ILCS in the treatment of vitiligo. Four treatment sessions will be done over 4~     to 6 months. The investigators will compare intralesional triamcinolone acetonide (active~     treatment) to normal saline (placebo).~   "
98589|NCT01766596|"~     The aim of the study proposed in Dijon is above all to focus on the possible relationship~     between age-related ocular pathologies (AMD and glaucoma) and et les degenerative~     neurological and cardiac pathologies.~      The principal objective is to seek in subjects who have undergone cerebral MRI and~     echocardiography, associations between the thickness of postganglionic fibers measured by~     Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment~     (psycho-cognitive tests, circulation time, MRI signs). This association will be studied~     after taking into account the principal environmental (particularly dietary) and genetic~     risk factors.~   "
98590|NCT01766583|"~     This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy~     and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292~     and lenalidomide combination therapy. Subjects will be followed for disease progression and~     collection of second primary malignancy (SPM) events. This dose escalation will be followed~     by an exploratory expansion phase in 3 cohorts of 12 patients each.~   "
99472|NCT01755078|"~     The study is designed to compare sevelamer vs. calcium-based phosphate binder in~     hemodialysis patients to achieve full-scale of medical care, including reduction of~     atherosclerotic risk factors, reduction of vascular access reconstruction rate, and~     pharmacoeconomic analysis.~   "
98591|NCT01766570|"~     The purpose of this study is to measure the beneficial effects of an optimized berries~     extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that~     including a polyphenol rich berries extract in daily feeding will improve insulin~     sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory~     profile, and oxidative stress markers.~   "
98592|NCT01766557|"~     The objective of our study is to determine the effects of fish protein on insulin~     sensitivity in PCOS women with insulin resistance, and its mechanism of action on glucose~     and endocrine metabolism. Our working hypothesis is that dietary fish protein improves~     insulin sensitivity, glucose tolerance, and related plasma endocrine and lipid abnormalities~     in PCOS women by restoring secretory β-cell function and insulin signaling to the PI~     3-kinase activity/Akt pathway. We further hypothesize that fish protein will improve cycle~     regularity and ovarian function.~   "
98593|NCT01766544|"~     This is a report of a protocol developed to improve asthma and COPD care in a primary care~     setting. The study was approved by an Ethics Committee and support by the Canadian Thoracic~     Society through an unrestrictive grant from GlaxoSmithKline. However, the study could not be~     done and the investigators report why, discussing the difficulties to perform such study.~     This information should be very useful to investigators planning this sort of study.~   "
98594|NCT01766531|"~     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU~     assessing the evolution of body composition using bioelectrical impedance analysis.~   "
98595|NCT01766518|"~     Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients~   "
98596|NCT01766505|"~     The purpose of this study is to compare efficacy and safety of candesartan and losartan in~     hypertension with heart failure.~   "
98597|NCT01766492|"~     Quality of life data following SBRT for prostate cancer has been obtained in only a small~     numbers of patients. A prospective study using validated quality of life questionnaires is~     needed to determine outcomes after treatment with SBRT. Our study will be the first~     essential step in developing a better evidence base on the comparative risks and benefits of~     SBRT treatment with regards to quality of life assessment and outcomes.~   "
98598|NCT01766479|"~     Background: Although subjects with first-degree relatives (FDR) with a history of colorectal~     cancer (CRC) are at increased risk for CRC, compliance to screening colonoscopy is~     suboptimal. Computed tomographic colonography (CTC) has been recognized as an alternative~     for CRC screening in average risk subjects, but less information is available on its~     performance in FDRs.~      Aims: To prospectively assess the accuracy of CTC as a screening tool in FDRs using~     colonoscopy (OC) with segmental unblinding as reference standard.~      Methods: Consecutive patients admitted with CRC diagnosis (index case, IC) were~     prospectively evaluated. Following the systematic identification of ICs with inherited~     predispositions to CRC, ICs who agreed to contact their FDRs ≥40 years old were included.~     Available FDRs were invited to undergo non-cathartic CTC, with OC the following day.~     Sensitivity/specificity/PPV/NPV of CTC was assessed for detecting subjects with any lesion~     ≥6 mm, ≥10 mm, and for advanced neoplasia ≥6 mm.~   "
98599|NCT01766466|"~     To demonstrate that patients treated with cangrelor can be directly switched to oral~     ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a~     significant decrease in the extent of inhibition of platelet aggregation.~   "
98600|NCT01766453|"~     South Asians have one of the highest rates of heart disease of all populations and a unique~     and deleterious obesity phenotype of increased body fat and inner-abdominal compared to~     those of European background. We have subsequently identified that this unique phenotype~     accounts for much of the increased heart disease risk in South Asians, with the greater~     amounts of inner abdominal fat being particularly implicated. In addition, South Asians in~     Canada have substantially lower levels of leisure-time physical activity.~      At present, we do not know the answers to the following questions:~        1. Is a conventional (standard) physical activity program that has proven effective at~          reducing inner abdominal fat and heart disease risk factors in populations of European~          background be effective in South Asians?~        2. Is an alternative physical activity program commonly practiced by South Asians (such as~          bhangra dance) be effective at reducing inner abdominal fat and heart disease risk~          factors in South Asians? In this study, we will perform a randomized controlled trial~          of three conditions—gym-based standard exercise program (SE),bhangra dance exercise~          program (BE) and non-exercise control (NE).We will recruit 75 post-menopausal South~          Asian women with abdominal obesity and assign them randomly to one of the three groups~          (25 per group).~      We anticipate that both the SE and BE programs will be superior to the NE group in terms of~     reducing VAT and CVD risk factors. Such findings will demonstrate that exercise is an~     effective method that favourably modifies the obesity phenotype of excess VAT in South~     Asians, and should be central to health promotion and disease prevention strategies.~   "
98601|NCT01766440|"~     The purpose of this study is to determine if the calcitriol absorption in pediatric subjects~     is comparable to that in adults and adolescents, with no significant impact on~     calcium/phosphorus metabolism.~   "
98602|NCT01766427|"~     1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic~          Kidney Disease.~        2. To observe if different-time treatment having an impact on Hypertension Patients With~          Chronic Kidney Disease.~   "
98603|NCT01766414|"~     Excessive inflammation is associated with tissue damage caused by over-activation of the~     innate immune system. This can range from mild disease to extreme conditions, such as~     multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked~     contrast to adaptive immunity which is very sensitive to immune modulators such as steroids,~     the innate immune system cannot be sufficiently targeted by currently available~     anti-inflammatory drugs.~      The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human~     endotoxemia model can modulate the innate immune response.~      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,~     prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be~     sampled to determine the levels of markers of the innate immune response.~   "
98604|NCT01766401|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).~   "
130396|NCT01348854|"~     To determine if arcuate incisions performed with the iFS femtosecond laser are safe and~     effective in reducing corneal astigmatism.~   "
98607|NCT01766362|"~     The aim of this study is to show that PRPC performed in a single session using a Pascal~     laser leads to better management of the disease (better rate of regression of neovessels,~     lower risk of a loss of visual acuity in the long term related to macular edema), a saving~     of time and better comfort for both patient and doctor.~   "
98608|NCT01766349|"~     The purposes of this study are to investigate in patients with newly diagnosed esophageal~     cancer: 1)changes in pulmonary and respiratory muscle function, functional capacity and~     quality of life during and after RT or CCRT treatment; 2)the correlations between these~     changes; and 3)the impacts of these changes on the postoperative pulmonary complications~     following esophagectomy.~   "
98609|NCT01766336|"~     To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure,~     in Moderate to Severe AD patients with agitation and aggression.~   "
98610|NCT01766323|"~     Oral morphine is often utilized as a convenient and effective method of achieving palliation~     of pain in the terminally ill cancer patients. However, at effective doses, a majority of~     patients do experience an undue amount of excessive sleepiness. Given the generally low~     expected survival periods among this patient population, the fact that morphine causes the~     patient to spend a significant period of remaining life in sleep, is often unacceptable for~     the patients and their families. Given the proven benefits of modafinil in conditions~     characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the~     investigators designed a prospective placebo controlled randomized trial by the addition of~     modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after~     randomization.~   "
98611|NCT01766310|"~     The purpose of the present study was to determine whether folic acid supplementation could~     reduce plasma homocysteine in obese children and to determine the association between~     dietary folate, serum folate and homocysteine level through the randomized double blinded~     placebo controlled trial.~   "
98612|NCT01766297|"~     The purpose of this research study is to compare the effects (good and bad) on women and~     their cancer using proton radiation therapy.~      This study is being done to see if proton radiation therapy will prove to be beneficial for~     women with early stage breast cancer. A clinical study is necessary to compare the results~     (good or bad) of proton radiation therapy.~   "
98613|NCT01766284|"~     Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light~     scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the~     uterine cervix can differentiate between grades of pre-invasive and invasive cervical~     disease and cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT)~     system to detect pre-invasive cervical disease and cervical cancer.~   "
98614|NCT01766271|"~     The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the~     feasibility and logistics of incorporating genetic risk information (9p21)into standard~     Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in~     primary care at 2 Duke Clinics.~   "
98615|NCT01766258|"~     The primary objective of the study is to assess the efficacy, carbidopa dose response and~     safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment~     of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.~   "
98616|NCT01766245|"~     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence~     (assessment of the expected biological equivalence of two pharmaceutical drug products with~     identical active ingredient) between subcutaneous injections of semaglutide produced by two~     manufacturing processes.~   "
98617|NCT01766232|"~     Epiphora, or uncontrolled tearing of the eyes, represents a common presenting complaint of~     patients seen by ophthalmologists. Epiphora may be due to non-obstructive causes, such as~     tear hypersecretion or functional tear pump failure, or obstructive causes. Functional tear~     pump failure may result from malposition of the eyelids, such as an abnormal out-turning~     (ectropion) or in-turning (entropion) of the eyelid.~      Currently methods to diagnose partial nasolacrimal duct obstruction are purely qualitative~     in nature. Our research goal is to quantitatively measure the pressure generated during~     conventional probing and irrigation (P&I), and to measure the resistance to irrigation of~     the nasolacrimal drainage system.~      The investigators will measure the pressure generated during conventional P&I using a~     disposable in-line pressure transducer. In addition, the investigators will use a syringe~     pump to deliver a constant flow rate of saline through a nasolacrimal cannula and measure~     the steady state irrigation pressure using the in-line transducer and digital pressure~     monitor. Resistance can be directly calculated from the known flow rate and pressure~     measurements.~      The investigators will compare both the pressure generated during P&I and the lacrimal~     drainage resistance between patients with lacrimal drainage obstruction and controls~     patients with no obstruction (functional tear pump failure) as determined by clinical exam.~      Clinical applications for measuring lacrimal drainage resistance include quantifying partial~     nasolacrimal duct obstruction, guiding the choice of surgical procedure, and determining the~     success of lacrimal drainage procedures.~   "
98618|NCT01766219|"~     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with~     advanced or metastatic cholangiocarcinoma that cannot be removed by surgery.~     6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood~     flow to the tumor~   "
98619|NCT01766206|"~     A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure~     requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety~     evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving~     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.~   "
98652|NCT01765777|"~     The purpose of the research study entitled Efficacy of Osteopathic Manipulative Medicine~     (OMM) and Phototherapy for Patients with Chronic Lower Back Pain is to investigate the~     hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and~     phototherapy will provide greater pain relief for patients with chronic lower back pain, as~     compared with standard medical management or either treatment alone.~   "
98653|NCT01765764|"~     This study will evaluate the safety and efficacy of bimatoprost solution compared with~     vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).~   "
99473|NCT01755065|"~     The purpose of this study is to find a more accurate postoperative pain assessment for~     teenager patients. This is important because a patient should not have a very strong pain~     medication such as morphine if the pain is just mild.~   "
98620|NCT01766193|"~     The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary~     incontinence is high. Previous studies have shown that pregnancy and childbirth are risk~     factors for developing prolapse. There is a lack of studies that follow women several years~     after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie~     vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this~     study is to get more knowledge about pathology of prolapse and incontinence, to enable~     development of preventive strategies for these conditions.~      Aim of the study is to determine whether the prevalence of symptoms and performed surgery~     for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal~     delivery and cesarean section 15-20 years after their first delivery.~      The investigators identify women that delivered their first child at St. Olavs Hospital,~     Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7,~     PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor~     musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of~     prolapse performed.~   "
98621|NCT01766180|"~     The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone~     or in combination, are effective in the treatment of memory problems in adult patients with~     memory impairment. We also evaluate effects of these medications on blood flow to the brain~     and fitness, to find whether the possible improvement in memory is associated with the~     alterations in these parameters.~   "
98622|NCT01766167|"~     To conduct the following evaluations in Korean healthy male adult volunteers receiving a~     single and multiple doses of MP-424 tablets:~        -  Pharmacokinetics of MP-424 after a single and multiple doses.~        -  Safety and tolerability of single and multiple doses of MP-424.~   "
98623|NCT01766154|"~     The purpose of this study is to evaluate tirofiban concentration in the blood over a period~     of 24 hours after tirofiban administration. Subjects with varying degrees of renal~     insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be~     cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to~     a slower extent compared to people without kidney problems. By comparing the tirofiban~     concentration profile between subjects with healthy kidney function versus with impaired~     kidney function, a tirofiban dosing recommendation for subjects with impaired kidney~     function can be made.~      This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25~     µg/kg administered intravenously over a 3 min period) will be administered to subjects with~     normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30~     mL/min CrCl) renal impairment with non-dialysis-dependent renal insufficiency~   "
98624|NCT01766141|"~     It is expected that mechanical low back pain (LBP) is associated with inflammatory changes~     localized to the affected tissues. Could such changes be detected in cells involved in the~     inflammatory process in an in vitro model? The investigators wish to test such a model to~     compare inflammatory markers in acute and chronic LBP patients and also examine the effect~     of spinal manipulative treatment (SMT) on changing the level of selected key inflammatory~     markers. The investigators hypothesize that:~        1. Proinflammatory markers will be elevated while antinflammatory markers will be reduced~          in acute LBP patients relative to chronic back pain patients as well as in healthy~          study participants who have no LBP or any inflammatory conditions (controls).~        2. SMT will cause a reduction in the production of proinflammatory markers while~          anti-inflammatory markers will increase relative to baseline levels as well as relative~          to controls~   "
98625|NCT01766128|"~     The aim of this study is investigation of neuroprotective effect of zonisamide in early~     Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study~     criteria will be enrolled and randomized into two groups alternately based on their visit~     date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified~     Hoehn&Yahr and modified Schwab&England activities of daily living scale will be determined~     and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d~     for 12 months and the other group will be treated by placebo for the same time. Primary~     endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily~     activity or cause psychosocial embarrassment. The mentioned scores will be registered every~     2 months for both groups by blinded neurologist and also regular blood test will be~     performed to prevent drug adverse events.~   "
98626|NCT01766115|"~     To assess the safety and tolerability of the use of telaprevir in the setting of~     post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2.~      To assess the election rate of postexposure prophylaxis for HCV-related occupational~     exposures in HCW.~   "
98627|NCT01766102|"~     A breast biopsy in the operating room may be needed in up to 15% of patients with an~     abnormality on mammogram. When an abnormality is present but there is no palpable mass, the~     abnormality must be localized with a wire before going to the operating room. This technique~     is also used when a breast cancer is present but there is no mass, in order to perform a~     targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire~     is taken to the breast imaging department for a specimen x-ray to ensure that the targeted~     abnormality is present within the specimen. If the abnormality is close to the edge of the~     specimen, additional tissue is often removed.~      A newer method for evaluating the specimen is to perform imaging in the operating room.~     Portable digital mammography units are available for this purpose. The Biovision digital~     specimen mammography system is FDA-approved and currently in use in over 200 centers in the~     United States. Several studies have shown that intra-operative digital mammography is as~     accurate as standard specimen mammography and takes less time to perform. It may also~     decrease the chance of having to go back to the operating room to take more breast tissue~     after lumpectomy because of cancer cells near teh margin(s) of the specimen on final~     pathology. Having to go back to the operating room to take more tissue is called a~     re-excision.~      The purpose of this study is to compare standard specimen mammography to intra-operative~     specimen mammography to quantify potential operating room time savings and to determine if~     the use of intra-operative specimen mammography decreases re-excision rates. We aim to see~     if intra-operative specimen mammography is more efficient and if it decreases re-excision~     rates.~   "
98975|NCT01761578|"~     This prospective, multicentre, open labeled, single arm, first in man interventional~     investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the~     treatment of patients with single de novo lesion of a native coronary artery with mandatory~     balloon predilatation.~   "
98628|NCT01766089|"~     Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5~     % of pregnancies.~      Tracheal intubation in the women with severe pre-eclampsia is usually associated with~     exaggerated transient increases in blood pressure, heart rate and maternal plasma~     catecholamine concentrations. These changes may lead to maternal cerebral oedema,~     haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine~     blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of~     the haemodynamic responses to tracheal intubation in this unique group of patients is~     demanding for the best of both mother and foetus.~      The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the~     haemodynamic and catecholamine responses to laryngoscopy and tracheal intubation in severe~     pre-eclamptics during Cesarean delivery under general anesthesia. Unfortunately, the use of~     1 µg/kg doses are associated with more maternal hypotension and neonatal respiratory~     depression requiring resuscitation. Moreover, the use of preinduction remifentanil bolus of~     0.5 µg/kg followed by a continuous infusion at 0.15-0.2 µg/kg/min is associated with~     significant attenuation of the maternal stress response to tracheal intubation with variable~     degree of neonatal depression in non-pre-eclamptic women. Whereas, the use of infusion rates~     of 0.1 µg/kg/min or less is less likely to produce neonatal depression.~      In our previous study, we demonstrated that the preoperative administration of~     dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the~     maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane~     anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is~     associated with higher postoperative sedation scores.~   "
98629|NCT01766076|"~     We hypothesise that atorvastatin changes immune activation among HAART-treated adults with~     suboptimal cluster cell differentiation 4 (CD4) recovery by 25%~   "
98630|NCT01766063|"~     The study aims to investigate the relationship between sleep quality, quality of life,other~     disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.~   "
98631|NCT01766050|"~     The purpose of this study is to determine the effects of belatacept on the pharmacokinetics~     of caffeine, losartan, omeprazole, dextromethorphan and midazolam~   "
98632|NCT01766037|"~     This research study is being performed to find out if a new device, AspireAssist Aspiration~     Therapy System, can help people with obesity to lose weight without causing too many side~     effects.~   "
98633|NCT01766024|"~     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and~     tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®~     (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to~     demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability~     parameters after single subcutaneous injection. Each dtug will be administered to each~     volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least~     14 days.~   "
98634|NCT01766011|"~     The purpose of this study is to assess overall growth of preterm infants fed a reformulated~     preterm infant formula during hospitalization. All study products meet levels of nutrients~     for the infant population as specified in the Infant Formula Act and all subsequent~     amendments.~   "
98635|NCT01765998|"~     Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It~     includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be~     effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing~     enterocolitis,helicobacter pylori infections, etc.~   "
98636|NCT01765985|"~     Interferential current has shown promising results for treating psoriasis with a good~     tolerance. Prospective randomized studies versus placebo are required to confirm the~     interest of such an approach.~      The Main objective is to assess the efficacy of interferential current for treating~     palmoplantar psoriasis.~      Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on~     the nails, to study the potential side effects.~   "
98637|NCT01765972|"~     The primary purpose of this clinical trial is to evaluate the eye's response to three test~     soft contact lenses as well as no lens wear, with respect to Corneal Staining.~   "
98638|NCT01765959|"~     Auricular acupuncture and cognitive behavioral therapy in the context of insomnia and low~     dose dependence of benzodiazepine-like drugs and other sleep medicine with addiction risk~      INTRODUCTION: Insomnia is a common health problem in Sweden, which increases with age and is~     more prevalent among women.~      It is defined by unsatisfied sleep quality during more than a month's time. The main~     symptoms are difficulties falling- and/or maintaining sleep, involuntary awakenings during~     the night of early morning, day time sleepiness and decreased will for day time activity due~     to sleepiness. Insomnia is ranked to be the fifth most common cause of prescription of~     medicine at the outpatient clinics in general health care in Sweden. In 2008 a prevalence~     study was initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU).~     The study showed that 24% of the Swedish population suffered from sleep disorders. Sleeping~     disorders can go on for many years and can therefore entail significant personal suffering.~      Usually sleep medicine combined with general sleeping advices is the first-hand treatment~     for insomnia. However, according to SBU, first treatment should be non-pharmacological, for~     instance cognitive behavioral therapy (CBT). Despite this recommendation the prescribing of~     sleep medicine is still high.~      There are studies that suggest auricular acupuncture (AA) to be an effective method to treat~     insomnia. However more evidence is needed to draw firm conclusions.~      AIM: The aim of the study is to investigate if AA is as effective as CBT to treat insomnia~     for patients who have stopped using benzodiazepine-like sleep medicine.~      METHOD: This is a randomized controlled study (RTC) including patients suffering from~     insomnia, with a low dose dependence of benzodiazepine-like drugs. The patients will be~     recruited from primary care and from an out-patient clinic specialized in sleeping disorders~     and also by add in the local news paper. The respondents will be randomized to one of two~     groups; group I will receive AA twice a week for 4 weeks; group II will receive CBT once a~     week for six weeks. After three months there will be a long-time follow up in order to~     investigate a potential long-term effect.~   "
98639|NCT01765946|"~     Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased~     cardiovascular risk and reduced life expectancy, as compared to the general population.~     AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy~     homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging~     pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin)~     and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to~     describe the effects of the AMPK pathway on longevity genes and inflammation in the setting~     of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment~     with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The~     investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in~     peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte~     polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2,~     CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells.~     Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined.~     In the in vitro study the investigators will evaluate the effects of AMPK activation or~     inhibition on longevity gene and protein expression.~   "
98654|NCT01765751|"~     The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck~     Pain Clinical Trial is to examine the patient‐centered clinical and biomechanical outcomes,~     doctor treatment delivery, and believability characteristics of a commonly used chiropractic~     procedure for the treatment of neck- or neck-related arm pain or disability.~   "
98640|NCT01765933|"~     1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary~     supplements. It is also used within party pills, often in conjunction with alcohol and~     other drugs, and has been associated with untoward effects when abused at high dosages. To~     our knowledge, no studies have been conducted to determine the combined pharmacokinetic~     profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based~     solely on case reports would be problematic, in particular when accepting testimony from~     patients in uncontrolled environment, potentially under the influence of alcohol and other~     drugs. This is especially true in light of the fact that no prospective studies have shown~     these effects. Hence, the intent of the present study was to determine the pharmacokinetic~     profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This~     represents a typical dosage within one serving of many popular dietary supplements~     containing DMAA.~   "
98641|NCT01765920|"~     The purpose of this study is:~        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper~          respiratory tract infections in adult patients.~        -  to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment of~          acute upper respiratory tract infections in adult patients.~   "
98642|NCT01765907|"~     Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound~     (HIFU).~   "
98643|NCT01765894|"~     Project description~      Research project title:~      Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.~      Project description and objective~      Obesity is so widespread in Denmark that 47% of the population is classed as overweight~     (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).~      The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics~     are overweight) has led to many studies which look at different forms of exercise for this~     group, because weight loss may improve the diabetes and even defer the onset of the disorder~     and in doing so lower complications and increase long term survival.~      For people who do not have type 2 diabetes, the work-induced increased sympathetic activity~     will lead to suppressed insulin secretion and increased glucagon secretion. This increases~     the endogenous glucose production from the liver and thus maintains a normal concentration~     of blood sugar in a physical training situation where the demand for glucose has increased.~      The theory behind the project is that the mechanisms that help to increase glucose~     production in the liver during physical activity are weaker in type 2 diabetics, which can~     cause hypoglycaemia during and after physical exercise. In other words, we want to study the~     liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in~     relevant healthy control subjects.~      Previous studies have indicated that this type of mechanism is not intact in type 2~     diabetics; because the level of insulin does not fall as expected during or after physical~     training. However, there are no existing studies that measure the liver's glucose secretion~     using stable isotopes during prolonged moderate physical work. Measuring this will help to~     clarify our understanding of glucose homeostasis in type 2 diabetics.~      This study is very relevant, because it may be expected that the preferred form of physical~     exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies~     also show that this form of physical exercise delivers health gains in terms of an~     improvement in insulin sensitivity and a reduction in the level of insulin.~      The objective of this study is to determine if the level of blood glucose stays constant~     before, during and after physical training and to examine the liver's ability to secret~     glucose accordingly.~   "
98644|NCT01765881|"~     For about 10% of pregnancies, it is necessary to induce delivery for medical reasons.~     Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix.~     In France, dinoprostone is the own approved medication. It is in the form of gel or~     sustained release device whose effectiveness and side effects are comparable. The vaginal~     misoprostol has no marketing authorization in France, but is sometimes used. Some data in~     the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not~     lead to more complications, was at least as effective and seems to be cost-effective~     compared with dinoprostone. Misoprostol with this dose and route of administration is now~     recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG~     Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines~     on induction of labor). According to HAS, the investigators still lack data on large samples~     to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of~     cesarean section, and lower cost compared to dinoprostone.~      The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs.~     dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5%~     difference.~   "
98645|NCT01765868|"~     This is a open label, single center, single oral dose, study of PRT054021, in healthy~     subjects.~   "
98646|NCT01765855|"~     This is a open label, single center, single oral dose, study of PRT054021, in healthy~     subjects.~   "
98647|NCT01765842|"~     Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus~     Nephropathy Resistant to Conventional Treatments~   "
98648|NCT01765829|"~     The purpose of this study is to assess if patients who continue with antipsychotic treatment~     for 12 or more months show the same risk of relapse (measured by PANSS) that patients with~     the same medical condition who have followed a discontinuation treatment scheme based in the~     presence of prodromes.~      The candidates should accomplish the following criteria: first episode of non-affective~     psychosis who have followed antipsychotic treatment for 12 months and who have already shown~     remission criteria.~   "
98649|NCT01765816|"~     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The~     extent of reduction will be intensity dependent.~      As part of the Generation 100 study, this sub-study project will investigate the effect of~     exercise on blood volume, cardiopulmonary health and heart function in healthy aging.~     Objective is to determine the acute effect of one endurance training session on blood volume~     in healthy elderly. The working hypothesis is that one interval training session increases~     total blood volume by 10% in healthy elderly, and that there will be no change after~     moderate continuous training.~   "
98650|NCT01765803|"~     This study will investigate the possibility of using the drug thioridazine (also called~     Mellaril) to increase the number of certain types of cells moving from the bone marrow to~     the circulation in a group of healthy humans. The types of cells we hope to collect are~     called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better~     understand a number of diseases and suggest new strategies for therapy. Perhaps the most~     important potential application of human stem cells is the generation of cells and tissues~     that could be used for cell-based therapies, as a renewable source of replacement cells and~     tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns,~     heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.~   "
98651|NCT01765790|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in~     subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).~   "
98698|NCT01765179|"~     The purpose of the study is to determine if oral testosterone undecanoate is effective and~     safe in the treatment of low testosterone in men.~   "
98655|NCT01765738|"~     To determine whether antibiotic impregnated PICC catheters have a lower infection rate than~     a conventional PICC catheter in a tertiary care patient population. Secondary goals will be~     to determine if there is a difference between the two catheters with early and late~     infections, to determine the cost comparison including extra cost of treatment for a line~     related infection, to determine if there are any non-infectious related complication~     differences between the two catheters.~   "
98656|NCT01765725|"~     The aim of the study is to develop, carry out, evaluate and measure the effects of a new~     patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary~     healthcare.~      In an randomized controlled trial design the effects of the patient education program on~     coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of~     life, self- efficacy, and illness perception will be compared with treatment as usual.~      The results of the main project will lead to the elaboration of the final patient education~     program that can be implemented in primary health care, as well as development of a training~     program for future program-conductors.~   "
98657|NCT01765712|"~     The purpose of this research study is to investigate whether or not platelet rich plasma~     (PRP) may help to improve tendon healing and decrease post operative pain in patients~     undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar~     tendons as autografts.~   "
98658|NCT01765699|"~     Aim To identify through data analysis key patients, surgeon and operative dependent~     variables which will improve the performance of knee replacement for primary osteoarthritis~      Research Question~        1. Can the investigators identify association between outcomes and patients~          characteristics using existing (already collected) datasets~        2. What are the characteristics of patients with poor outcome after knee replacement~        3. What can be done to improve the outcome of patients at risk of poor results~   "
98659|NCT01765686|"~     Energy devices are used routinely during thyroid surgery to aid surgical dissection and to~     stop bleeding. The newer generation energy devices have several advantages over older~     machines. The two most commonly used newer generation energy devices are the Harmonic~     scalpel and the Small Jaw bipolar device. Currently there has been no randomized controlled~     trial that compares both devices side to side. We aim to compare the effectiveness of these~     two newer generation energy devices in thyroid surgery.~   "
98660|NCT01765673|"~     The purpose of this study is to develop a vibratory self-trainer for the treatment of~     dysphagia post-stroke.~      The aim is to identify the optimal stimulation characteristics for use with participants~     with swallowing problems including:~        -  Frequency of vibration~        -  Mode of vibration either continuous or pulsed~        -  Pressure of device against the neck~        -  Duration of vibration to allow a participant to initiate a swallow~   "
98661|NCT01765660|"~     The purpose of this study is to evaluate the utility of treating patients experiencing~     refractory chronic graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal~     stem cells from third-party donors. The objective was to evaluate the effect and safety of~     such treatment on refractory chronic graft-versus-host disease.~   "
98662|NCT01765647|"~     Celiac disease (CD) is an autoimmune disease of the small intestine caused by the~     consumption of gluten proteins from widely used food sources such as wheat, rye, and barley.~     Exposure of the small intestine to gluten causes an inflammatory response, leading to the~     destruction of intestine lining, often with severe symptoms including diarrhea, abdominal~     distention, fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong~     disease and the only treatment currently available is strict adherence to a life-time gluten~     free diet (GFD). However, adhering to this diet is difficult as gluten proteins are found in~     many food products. Therefore, the gluten-free diet has both lifestyle and financial~     implications for the individual and thus has been potential for impacting adversely on their~     quality of life.~      Various approaches are being studied to reduce the need for careful control of the diet for~     those with CD, including the use of antibodies such as IgY. IgY is produced from the egg~     yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal~     toxicity, for those without egg allergy, and offer low-cost, hygienic production of study~     product. Once the IgY antibody is put into capsule form, it is called AGY.~      Individuals with CD will be recruited only if they have a history of biopsy proven CD,~     currently follow a GFD but continue to have mild to moderate symptoms related to gluten~     exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at~     screening. Those enrolled will have a 2 week run-in period where diet and symptoms are~     recorded, and will then receive AGY capsules to take with meals over a 4 week period.~     Outcomes will be measured by examining lab test results including antibody levels, symptoms,~     and quality of life.~   "
98663|NCT01765634|"~     The purpose of this study is to evaluate the utility of treating patients experiencing~     refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem~     cells from third-party donors. The objective was to evaluate the effect and safety of such~     treatment on refractory acute graft-versus-host disease.~   "
98664|NCT01765621|"~     Leumit Health Services, an health maintenance organization operating in Israel, will~     incorporate a web-based, decision support system for handling drug-drug interactions and~     drug information, termed DDI+ reinforced with patient specific pharmacogenetic data. The~     investigators hypothesize that implementing such a system will reduce health-care~     expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).~   "
98665|NCT01765608|"~     This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with~     moderate to severe obstructive sleep apnea. Patients will be randomized to receive~     zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5~     month open extension part will follow when patients in the tablet groups will all receive~     zonisamide. Patients in the open CPAP group will continue with CPAP treatment.~      Study hypothesis:~      Controlled pharmacological weight reduction with Zonisamide will result in elimination of~     OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the~     mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further~     it is hypothesized that zonisamide has a direct pharmacological effect on respiratory~     control during sleep by its carbonic anhydrase inhibitory effects and this will result in a~     reduction of sleep disordered breathing.~   "
98976|NCT01761565|"~     Determine the plasma concentration profile after single and multiple dosing of Sufentanil~     NanoTabs~   "
98666|NCT01765595|"~     Leumit Health Services, an health maintenance organization operating in Israel, will~     incorporate a web-based, decision support system for handling drug-drug interactions and~     drug information, termed DDI+. the investigators hypothesize that implementing such a system~     will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging~     procedures).~   "
98667|NCT01765582|"~     This randomized, open-label, multicenter study will evaluate the efficacy and safety of~     FOLFOXIRI/Avastin (bevacizumab) regimens (concurrent and sequential) versus FOLFOX/Avastin~     in first-line in patients with metastatic colorectal cancer. Patients will be randomized to~     receive Avastin 5 mg/kg intravenously every 2 weeks with either concurrent or sequential~     FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance~     therapy with Avastin plus either leucovorin/5-fluorouracil or capecitabine until disease~     progression occurs. After disease progression, patients will receive treatment with a~     fluoropyrimidine-based chemotherapy plus Avastin.~   "
98668|NCT01765569|"~     This open-label, multi-center, three-period, one sequence study will investigate the effect~     of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable~     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a~     V600-activating mutation of BRAF without acceptable standard treatment options. Patients~     will receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin~     in Periods A and C. Eligible patients will have the option to continue treatment with~     vemurafenib as part of an extension study (NCT01739764). The anticipated time on study~     treatment is approximately 36 days.~   "
98669|NCT01765556|"~     This open-label, multi-center, three-period, one sequence study will investigate the effect~     of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable~     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a~     V600-activating mutation of BRAF without acceptable standard treatment options. Patients~     will receive a single dose of vemurafenib in Periods A and C and multiple doses of~     ketoconazole in Periods B and C. Eligible patients will have the option to continue~     treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time~     on study treatment is approximately 19 days.~   "
98670|NCT01765543|"~     This open-label, multi-center, three-period, one-sequence study will investigate the effect~     of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation~     positive metastatic melanoma or other malignant tumor type that harbors a V600-activating~     mutation of BRAF without acceptable standard treatment options. Eligible participants will~     have the option to continue treatment with vemurafenib as part of an extension study GO28399~     (NCT01739764).~   "
98671|NCT01765530|"~     The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear)~     for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators~     hypothesize that a protocol of routine ETT cleaning with endOclear may increase the ETT~     luminal volume measured at extubation compared to the current standard of care. The device~     may therefore be clinically useful by better maintaining the ETT original function.~   "
98672|NCT01765517|"~     Probiotics, which are believed to be health promoting live microorganisms, have been~     reported to influence circulating endotoxin levels. Ingestion of the live cultures may alter~     gut mircobiota in a beneficial manner to reduce inflammation; although their mechanism and~     influence to reduce inflammation in T2DM is not established for this disease state.~     Therefore, the aim of this study is to (1) characterize the beneficial effects of probiotics~     on circulating endotoxin levels and other biomarkers related to systemic low-grade~     inflammation in patients with T2DM; (2) Compare circulating endotoxin levels and~     inflammatory cytokine levels between patients treated with probiotics or placebo to examine~     the beneficial effects of probiotics on reducing the inflammatory status, through assessment~     of systemic markers (adipokines, endotoxin, cytokines); (3) to examine the effects of~     probiotics on gut microflora in order to understand the mechanism for such change in~     inflammatory status. To achieve this, 120 consenting adult Saudis, naïve or newly diagnosed~     T2DM patients without co-morbidities, will be enrolled in this clinical trial and randomized~     to receive twice-daily placebo or probiotics for 26 weeks in a double-blind manner. Glycemic~     inflammatory markers will be measured and fecal samples analysed, interventions will be done~     at baseline, 4, 8, 12 and 26 weeks. It is envisaged that probiotics will induce beneficial~     changes in gut mircobiota, reduce the systemic inflammatory state through altering systemic~     endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM~     subjects. This will have a fundamental impact on how we should treat the inflammatory~     component of T2DM, particularly once the results are verified in a larger cohort of~     patients, as this could have very dramatic effects on how we treat patients with T2DM.~     Reducing the pathogenesis of T2DM by dampening the inflammatory response, which may also~     impact on insulin resistance status and health of the individual, will have clear benefits.~     This could have profound effects on preventative T2DM management, as well as current T2DM~     care without excessive cost for the wider Saudi health economy.~   "
98673|NCT01765504|"~     Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative~     effectiveness trial the specific aims of this study are:~        1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing~          cardiac surgery in a multicenter study design.~        2. To demonstrate the feasibility of using a standard algorithm for treating rScO2~          desaturations during cardiac surgery in a multicenter study design.~   "
98674|NCT01765491|"~     Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient~     preparation and colonoscopy. The aim of the investigators study is to compare the efficacy~     and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in~     hospitalized patients undergoing colonoscopy.~      This is a single-center, prospective, endoscopist-blinded study in which hospitalized~     patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one~     gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The~     primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The~     investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa~     scale between arms. Secondary end points are patient compliance and tolerance.~   "
98675|NCT01765478|"~     HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a~     member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed~     in hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in~     multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR)~     signaling cascades and is an essential mediator not only in B-cell dependent but also in~     myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel~     therapeutic agent for the treatment of autoimmune diseases such as rheumatoid arthritis~     (RA).~      In view of the above, further development of HM71224 for the treatment of RA is warranted.~     In this first-in-man (FIM) study, a single and multiple dose escalation design will be~     employed, in which the primary objective is to evaluate the safety and tolerability of the~     compound. The biomarkers included as pharmacodynamic (PD) variables are chosen as they are~     indicators for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and~     pERK).~   "
98676|NCT01765465|"~     Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually~     manifested by the presence of abdominal symptoms following gallbladder removal. The~     pathogenesis of PCS has not been identified; therefore there is no consensus of medical~     treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric~     acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from~     patients with cholesterol gallstones, and to promote biliary lipid secretion.~      The purpose of this study is to determine whether Rowachol is useful in the prevention of~     PCS and symptoms change after laparoscopic cholecystectomy~   "
98677|NCT01765452|"~     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of~     Plavix with Astrix.~   "
98678|NCT01765439|"~     The aim of the study is to determine, whether administration of VSL#3 (Original De Simone~     formulation) probiotic preparation can alter the bile acid metabolism in patients with~     inflammatory bowel disease.~   "
98679|NCT01765426|"~     The purpose of this study is to compare the safety, tolerability and immunogenicity of~     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered~     intradermally in varied dosing schedules and via different methods of administration~     (conventional needle/syringe versus needle-free PharmaJet® injector).~   "
98680|NCT01765413|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the~     Innovative Medicine Initiative. The project involves a series of clinical studies using~     licensed vaccines as benchmarks to generate clinical data on inflammation and identify~     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify~     biomarkers that can predict the occurrence of beneficial and detrimental effects in response~     to a vaccine. Such biomarkers could be used in future vaccine development programs to~     optimize selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalized use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     target population. Forty eight subjects will be randomised into three groups to receive: A)~     Varicella zoster vaccine (n = 20), B) Yellow Fever vaccine (n = 20), C) Saline placebo (n =~     8). Following a screening visit, participants will undergo a seven day residential visit~     which will include immunization and intensive monitoring of physiological (e.g. heart rate,~     oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters.~     This visit will be followed up by four outpatient visits with further monitoring and blood~     samples.~   "
98681|NCT01765400|"~     The investigators aim to determine if patients with systolic heart failure treated with~     prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.~   "
98682|NCT01765387|"~     The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic~     exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled~     repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople~     are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed~     (control group) after complete a spinning session.~   "
98683|NCT01765374|"~     To detect by sonography relapse of disease activity prior to clinical symptoms in RA~     patients treated by rituximab.~   "
98684|NCT01765361|"~     Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also~     includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are~     partly independent of lesion formation and relapse activity , but represent the direct~     driver of clinical long-term disability and cognitive decline.~      Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor~     EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and~     numerical data which are closely correlated to the EDSS. As EP capture the functional~     integrity of the examined systems they represent a method unbiased for directional changes,~     while remaining specific for the neuronal function, and hence can measure deterioration, as~     well as improvement, a germane advantage to capture drug response.~      High-resolution electroencephalography (EEG) allow for explorative analysis of potential~     surrogate markers for cognitive decline.~      Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment~     effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense~     lesions as well as on the annualized relapse rate in a recent phase II trial in~     relapsing-remitting MS.~      The present study will investigate the effects of OCR on multimodal evoked potentials (EP),~     Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue~     will be explored.~   "
98685|NCT01765348|"~     Specific-language-impairment (SLI) is defined as a significant disorder in language~     development, which affects one's daily functioning, but not attributable to sensory,~     intellectual or neuropsychological deficit. Children with SLI make up one of the largest~     subgroups of students with special educational needs (SEN) in Hong Kong. Without appropriate~     intervention, SLI may persist into adolescence and lead to long-term literacy difficulties~     and social rejection, which were found to be associated with societal problems like~     unemployment and crime commitment. Among the language domains, syntax/grammar has been~     viewed as a core deficit in these children. Speech-Language-Pathologists (SLPs) often~     provide intervention on this aspect for them. However, very few intervention efficacy~     studies could be identified.~      Without pertinent research evidence, clinical-decision-making in treatment approach~     selection may be dubious. This study aims to evaluate the efficacy of two procedures for~     syntax intervention, namely the Sentence-Combining (SC) and Narrative-Based (NAR) procedures~     using a randomized-controlled-trial (RCT) design. These two procedures have been indicated~     to be effective in previous case reports and expert opinions. By using the rigorous study~     design of RCT, this study provides stronger evidence to support clinicians in determining~     the most effective treatment procedure. To achieve sufficient statistical power to detect~     the treatment difference, 52 children with SLI will be recruited and randomly assigned to~     one of the treatment groups. The primary outcome will be measured by a standardized language~     assessment. Intention-to-treat analysis will be employed. Pre- and post-treatment scores on~     the outcomes will be subject to analyses of covariance with the pre-treatment scores as the~     covariate.~   "
98928|NCT01762189|"~     Thirteen hospitals in China will participate in the study, which aims to provide data on~     serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates,~     and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.~      We hypothesize that the study can be value in identifying and implementing strategies for~     risk reduction.~   "
98686|NCT01765335|"~     HF represents a major burden in the developed world. Mortality and rehospitalization rates~     post-discharge in patients admitted with HF may be as high as 15%-30% within 60-90 days,~     respectively. Given that rehospitalization drives much of the cost associated with HF, there~     has been increased interest in predicting risk of rehospitalization as a means to control~     health care costs. These risk stratification models can serve as important clinical tools by~     helping to identify those patients who are at very high risk may be observed more closely or~     treated more intensively. The most important predictors for the combined endpoint of death~     or rehospitalization were admission serum creatinine concentration, systolic blood~     pressure,admission hemoglobin level, discharge use of ACE-Ior ARBS, and Pulmonary disease.~     Other independent predictors during hospitalization of readmission and mortality included~     low admission Kansas City Cardiomyopathy Questionnaire score, high BNP, hyponatremia,~     tachycardia, hypotension, absence of b-blocker therapy, and history of diabetes and~     arrhythmias. Nevertheless, both models fail to provide the treating physician a simple~     decision making tool for predicting which patient is stable enough to be discharged from the~     hospital without a high risk of readmission. The Non Invasive Cardiac System (NICaS,~     Israel), calculates the cardiac output by measuring impedance cardiography in a tetra-polar~     mode, derived from electrodes placed on both wrists or one wrist and the contra-lateral~     ankle. This simple to operate, non-invasive technique was validated in a few studies to be~     reliable in estimation of CO compared to traditional, invasive techniques in different~     settings including HF patients. A previous study demonstrated that parameters derived from~     this system showed a highly significant correlation to echo estimated EF and serum BNP in~     chronic HF patients and were equally able to predict complications in this population.~     Aim:To assess whether the NICaS system can identify high risk HF patient for readmission~     prior to their discharge compared to serum BNP measurement.~   "
98687|NCT01765322|"~     The purpose of this study is to determine whether laser-assisted zona thinning improve the~     implantation rate of the women of advanced age in the first IVF/ICSI cycles~   "
98688|NCT01765309|"~     Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin~     during breast reconstruction with tissue expanders results in decreased pain using a~     blinded, randomized, controlled trial.~   "
98689|NCT01765296|"~     -  6-week Efficacy Study The objective of this study is to prove the safety and~          non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and~          analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in~          patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The~          primary efficacy parameter is the difference from Baseline to Week 6 in the Western~          Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.~        -  Extended Safety Study The objective of the Extended Safety Study is to collect a total~          of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data,~          and an additional 18 weeks of safety data for those subjects who agree on the consent~          form to continue into the Extended Safety Study. Subjects will be administered CG100649~          2 mg only during 18 weeks of Extended Safety Study.~   "
98690|NCT01765283|"~     The purpose of this study is to assess the safety and to appraise the efficacy of one cycle~     of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in~     paediatric patients suffering from CN or UCD.~      The study duration: 12 months starting from the day of treatment: 6 months active~     surveillance and 6 months observation post-infusion.~   "
98691|NCT01765270|"~     Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular~     events (for example, heart attack) and the risk is related to one's overall control of blood~     glucose levels. In this study the investigators will measure the effects of saxagliptin,~     compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery.~     The investigators will use samples of the patients' blood and tissue to measure and evaluate~     indicators of the body's response to the treatment. This study is being done to evaluate the~     effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or~     controlling a person's blood glucose levels during and after CABG surgery will produce~     better clinical outcomes (for example, better heart health).~   "
98692|NCT01765257|"~     Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD)~     and/or in de novo patients, apathy is relatively frequent (estimated to 23%). However, the~     neuropathological bases of apathy are still unknown. However, recent data suggests that~     apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.~      Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the~     MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in~     Parkinson's disease.~      The primary outcome is to demonstrate a significant reduction of apathy using the Lille~     apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease,~     using a treatment by rasagiline.~   "
98693|NCT01765244|"~     Phase I- II clinical trial to evaluate the feasibility of the method and the absence of~     relevant side effects derived from product implant.~      HYPOTHESIS: Once designed the nanostructured artificial human corneas by the Tissue~     Engineering Group of the University of Granada, and after evaluating their suitable~     properties ex vivo and their in vivo utility by means of anterior lamellar keratoplasty in~     laboratory animals, it is necessary to proceed to clinical evaluation in human patients~     suffering from severe corneal pathology. The results obtained during pre-clinical study,~     both in laboratory and in experimental animals, suggest that nanostructured artificial human~     corneas could help to treat various corneal diseases that occur with any substance loss or~     serious structural alteration, with no relevant side effects.~   "
98694|NCT01765231|"~     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg~     Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.~   "
98695|NCT01765218|"~     We wish to see whether topiramate (an anti-epileptic agent) improves the outcome of babies~     with neonatal hypoxic encephalopathy who are receiving whole body cooling.~   "
98696|NCT01765205|"~     Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to~     screen for left-sided cardiac lesions. These studies have shown that the occurrence of~     critical congenital cardiac malformations among asymptomatic newborns is high; the technique~     of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple~     to operate(requires little time and can be done in the newborn nursery) and is cost~     effective; there is effective follow-up test (heart ultrasound) and available interventions~     have an effect on outcome for diagnosed newborns. The importance of this research project is~     to examine the overall helpfulness of measuring oximetry in newborn infants using somatic~     oximetry, as well ast to prepare for a population based study in the state of Florida.~   "
98697|NCT01765192|"~     This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast~     10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced~     expiratory volume in the first second (FEV1).~   "
98699|NCT01765166|"~     This Competing Renewal project continues the research and development of a parent-focused~     intervention, Parent Guide to SSGRIN, which parallels an established child-focused~     intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years],~     in order to teach and reinforce the same social skills and concepts within the home~     environment. A primary goal is to address questions of relative impact, longer-term~     treatment benefits, and differential treatment effects of the Parent Guide training on~     children's social skill development across settings and populations.~   "
98700|NCT01765153|"~     The objective of the study was to determine the efficacy of two forms of physical therapy~     training, one emphasizing precise, visually guided walking over obstacles and on targets~     (Precision Training), the other emphasizing mass practice of walking on a treadmill~     (Endurance Training). The hypothesis was that visually guided training (Precision) may be~     especially efficacious because it engages the motor cortex, whose input may facilitate~     improvements in functional walking. Participants are individuals with a chronic (≥7 months~     post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would~     preclude participation in an intensive training program. A randomized, single-blinded,~     cross-over design was used to randomly allocate participants to start with Precision or~     Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months,~     followed by a 2-month rest period, identified as Rest Period I. Participants then returned~     for 2-months of training in the other method, identified as Training Phase II, followed by~     another 2-month rest, Rest Period II. Measures of walking speed, distance, skill,~     confidence, as well as depression were obtained at least 3 times before any training, then~     monthly thereafter. Electrophysiological measures were taken before and after each phase of~     training and period of rest. Change scores were used to determine how each phase of training~     and rest influenced the scores (see below).~   "
98701|NCT01765140|"~     This is a continuing project to provide 3,4 diaminopyridine (DAP) under a treatment-use IND~     to patients with Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndrome~     (CMS).~   "
98702|NCT01765127|"~     This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine~     (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk~     Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to~     further investigate the safety profile of asenapine in clinical practice. The aim of this~     study is to proactively capture safety and drug utilisation data in the post-marketing phase~     of license approval of asenapine as prescribed to patients by general practitioners (GPs) in~     England. This data is obtained through the completion of questionnaires by GPs.~   "
98703|NCT01765114|"~     The aim of this study is therefore to investigate the efficacy of the PEG-formulation to~     reduce the frequency and duration of genital herpes recurrences, to assess its safety and~     tolerability and to investigate its effect on shedding.~   "
98704|NCT01765101|"~     Using double blind, randomized controlled design to study the immediate, short-term and~     intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles~     and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis,~     under the basis of International Classification Functioning, Disability and Health.~   "
98705|NCT01765088|"~     This study is being conducted to help determine whether the addition of~     Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ)~     in vivo and vitro, when given along with temozolomide during the monthly cycles that follow~     radiation, is able to delay tumor growth, shrink tumors, or impact how long people with~     newly diagnosed high-grade glioma.~   "
98706|NCT01765075|"~     The purpose of the study is to gather electrophysiological data using a multi-electrode~     mapping catheter during a clinically indicated cardiac ablation procedure for the treatment~     of persistent atrial fibrillation.~   "
98707|NCT01765062|"~     Many author have exposed the rapid and slow expansion, the diversity of activation and~     containment protocols and the follow-up time, justify the need for more studies to evaluate~     the effects to the ERM for the long-term.~   "
98708|NCT01765049|"~     Breast density change after short term use of aromatase inhibitor in postmenopausal ER~     positive breast cancer would predict endocrine responsiveness~   "
98709|NCT01765036|"~     Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor~     of the pancreas. Given its poor prognosis and the major therapeutic consequences, the~     discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted~     as the most sensitive imaging procedure for the detection and characterization of pancreatic~     tumors [1-3]. Nevertheless it remains difficult to differentiate, on morphological features,~     PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration~     (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis~     of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic~     adenocarcinoma (PA) remains low (30-70%) in the published prospective series [4]. So, in~     case of negative result, the choice between surgery and follow-up remains difficult.~     Additional criteria to get the decision are then warranted.~      The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in~     real time with imaging specific methods seems useful to improve their characterization [4-8]~     either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic~     EUS (CH-EUS).~      The aims of this prospective multicenter study is:~        1. to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for~          the diagnosis of PA;~        2. to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.~   "
98710|NCT01765023|"~     The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin~     and metformin single or co-administered in healthy volunteers~   "
98711|NCT01765010|"~     The purpose of this study is to compare the effect of inactive and active vitamin D on serum~     sclerostin and dickkopf1 levels.~   "
98929|NCT01762176|"~     To compare the effectiveness of two treatment strategies in early rheumatoid arthritis~     (ERA), namely the delayed usual care and early intensive care, in Hong Kong.~        -  The delayed usual care reflects the usual treatment practice in Hong Kong~        -  The early intensive care includes tight monitoring and immediate adjustment of therapy~   "
99016|NCT01761045|"~     The objective of this study is to confirm that Monosodium L-Glutamate (MSG) supplementation,~     both alone or in combination with Nucleic Acid (IMP), enhances satiety and decreases food~     intakes at the next meal in healthy female adults.~   "
98712|NCT01764997|"~     Primary Objective:~      To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to~     etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an~     inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity~     Score for 28 joints (DAS28).~      Secondary Objectives:~      To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab~     in combination with methotrexate (MTX).~      To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in~     combination with methotrexate (MTX).~      To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in~     patients with rheumatoid arthritis (RA).~   "
98713|NCT01764984|"~     Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an~     estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans~     will be affected by the disease. Despite the relative good track record of total knee~     replacement, it remains a biomedical device that can fail over time. A recent study looking~     at the current mechanisms of total knee replacement failures, listed polyethylene wear and~     osteolysis around implants. The material used for polyethylene insert as well as the~     conformity of articular surface of implants has been modified to decrease wear. While~     introducing modularity, the usage of metal backing in tibial base plates became obvious as~     it offered better stress distribution to the proximal tibial bone. However, it introduced~     other modes of failures. Micromotion has been demonstrated between the metal backing and the~     tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for~     revision. Factor influencing the surgeon's choice of implant include: reproductibility and~     longevity of results, technical difficulty of implantation, cost, and impact on bone stock.~     The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic~     bone biology. Studies have described a significant decrease in postoperative Bone mineral~     density (BMD), adjacent to the implants, after total knee replacement. No study, to our~     knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial~     base plate designs. Direct effect of changes in design on overall implant survival can be~     studied with randomized clinical trials isolating specific variables. No randomized clinical~     trial has looked at tibial insert stiffness and modularity, and it effect on bone density~     changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity~     as study variables, one would aim at randomizing an homogenous patient population undergoing~     total knee arthroplasty with implants of similar articular geometry designs with different~     tibial insert modularity and stiffness.~   "
98714|NCT01764971|"~     Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate~     to severe behavioral problems including learning difficulties, memory affection .These~     changes could be due to the presence of minute capillary dysfunction~   "
98715|NCT01764958|"~     The proposed research has the potential of contributing to the limited empirical literature~     on the relationship between maternal sensitivity and motor development of preterm infants.~     If indeed maternal attuned behaviors will be found to be associated with the quality of~     motor development, such a finding will support the effectiveness of physical therapy in~     guiding caregivers to attune their holding and touch of preterm infants.~      We hypothesize that mothers and infants' attunement during observed interaction will be~     related to the quality of preterm infants' spontaneous movements in the following ways:~     First, better maternal attunement to the infants needs, and in particular attunement of~     holding and touch will be associated with better quality of spontaneous movements of the~     infants. Second, more initiations and/or involvement of infants in interaction will be~     associated with better maternal attunement to the infant. Third, more initiations and/or~     involvement of infants in interaction will be associated with better quality of spontaneous~     movements and better achievements in developmental milestone. All hypotheses will be~     examined while controlling for maternal use of SSC method during hospitalization after birth~     and family demographic backgrounds.~   "
98716|NCT01764945|"~     The objective of the current study is to investigate the relative bioavailability of two~     different doses of BI 201335, administered as soft gelatine capsule in comparison to the~     equivalent doses of three different oral solution per dose of BI 201335.~   "
98717|NCT01764932|"~     In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will~     determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.~      Previous studies have drawn contradictory conclusions based the potential flaw assumption of~     100% success rate for correct epidural catheter placement in the thoracic region.~   "
98718|NCT01764919|"~     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic~     imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.~   "
98719|NCT01764906|"~     The purpose of this study is to evaluate the efficacy and safety of Novosis in~     posterolateral fusion~   "
98720|NCT01764893|"~     The null hypothesis for this study is that the combination of solifenacin and Percutaneous~     Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators~     anticipate a 20% improvement in patients receiving combination therapy as measured by the~     OAB-q (Overactive Bladder questionnaire) scores.~   "
98721|NCT01764880|"~     Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and~     participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating,~     among other activities, cell invasion associated with cancer metastasis, angiogenesis, and~     inflammation. The heparanase enzyme is a promising target for development of new anticancer~     drugs. HS and the structurally related heparin are present in most animal species. As an~     analogue of the natural substrate of heparanase HS, heparin is considered to be a potent~     inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced~     oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity~     and are strictly related to the anti-heparanase activity. In preclinical murine models~     SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models,~     with a significant reduction of subcutaneous growth of different multiple myeloma cell~     lines, when SST0001 was administered either alone or in combination with dexamethasone. The~     purpose of this study is to determine the safety and tolerability of escalating doses of~     SST0001 in the treatment of advanced refractory multiple myeloma.~   "
98722|NCT01764867|"~     The purpose of this study is to compare treatment outcomes between measurement based~     Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with~     major depressive disorder.~   "
98723|NCT01764854|"~     The purpose of this study is to determine if the study drug is safe, tolerable and active in~     reducing fluid overload/weight gain between dialysis sessions for patients with End Stage~     Renal Disease on Hemodialysis.~   "
98724|NCT01764841|"~     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of~     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days~     every other 28 days or for 14 days every other 14 days over 48 weeks.~   "
98725|NCT01764828|"~     This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety,~     tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in~     combination with gemcitabine in Asian patients with advanced or refractory solid~     tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single~     dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine~     and BAY86-9766.~      Safety evaluation will include adverse events assessment, vital signs, laboratory tests,~     12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination~     at various time points during the study.~   "
98726|NCT01764815|"~     The purpose of this study is to provide proof-of-concept that directional stimulation, in an~     intraoperative setting, is perceivable in a subject and is different from omnidirectional~     stimulation. The tests will be performed using a dedicated DBS lead connected to external~     neurostimulator.~   "
98727|NCT01764802|"~     This randomized phase II trial studies how well psychosexual intervention works in patients~     with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual~     and psychosocial function.~   "
98728|NCT01764789|"~     This pilot clinical trial studies stress reduction in improving quality of life in patients~     with recurrent gynecologic or breast cancer. Participating in a stress reduction program may~     help improve quality of life in patients with gynecologic or breast cancer.~   "
98729|NCT01764776|"~     This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects~     with impaired hepatic function and healthy subjects with normal hepatic function.~   "
98730|NCT01764763|"~     Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool~     to accurately assess ascending aorta disease. To date, several studies have reported that~     EAS is superior to TEE and surgical palpation~   "
98731|NCT01764750|"~     Surgical wound infections remain a serious problem despite aseptic techniques and the use of~     prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in~     high-risk patients receiving long segment instrumented spinal fusions for deformity~     correction and present potentially catastrophic consequences. Given this, the high cost of~     treatment, and a payer system unable to support such expenses, investigators must make every~     effort to find new cost-effective ways to prevent these complications.~      Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin~     into spinal surgery wounds immediately prior to wound closure. This method, known as~     intrasite application, is adapted from techniques used to prevent infection in joint~     replacement surgeries. The motivation for this practice is to maximize antibiotic~     concentration within the wound while minimizing systemic concentration and toxicity, (the~     inverse of the situation when using IV antibiotics). While the popularity of intrasite~     delivery has grown rapidly, this has occurred without prospective scientific evidence.~     Recently, three retrospective papers including nearly 2,500 treated patients, indicated that~     intrasite Vancomycin reduces wound infections without increasing adverse events[1-3].~     However, there are no published data on the dosing or pharmacokinetics of intrasite~     Vancomycin, let alone prospective trials of its efficacy and safety.~      The investigators propose to perform the first prospective trial of intrasite Vancomycin~     pharmacokinetics and safety. Study objectives will include standardizing application and~     dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal~     potency, and dose selection for use in future studies. This will be accomplished by~     enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized~     Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous~     blood and wound seroma fluid will be measured at regular intervals after surgery to~     establish pharmacokinetic parameters. Preliminary data regarding local and systemic adverse~     events including wound healing, fusion rate, and toxicity will be prospectively collected.~     The ultimate goal of this learning-phase study is to gather sufficient information regarding~     application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare~     for a Phase III efficacy trial.~   "
98732|NCT01764737|"~     The purpose of this study is to evaluate the safety and tolerability of IV administration of~     VX15/2503 in patients with multiple sclerosis. The escalation part of the study will~     determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is~     found.~   "
98733|NCT01764724|"~     Sodium-related claims on food labels should help people find lower sodium food choices;~     however consumer attitudes and understanding of such claims are unknown.~      The objective of this study was to evaluate: 1) the attitudes and understanding to different~     types of permitted sodium claims and 2) the effect of hypertension on responses to such~     claims.~   "
98734|NCT01764711|"~     This study is to determine different chemical levels in the blood during a low salt diet.~     This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)~   "
98735|NCT01764698|"~     Anxiety disorders are highly prevalent among those with substance use disorders, but the~     majority of addictions treatment centers provide little to no evidence-based treatment for~     anxiety disorders. Furthermore, tension reduction models suggest that treating anxiety~     should also improve substance use outcomes. This study is aimed at improving symptoms for~     people who have substance use and anxiety problems. The study is comparing regular Intensive~     Outpatient treatment for addiction to Intensive Outpatient treatment for addiction plus~     treatment for anxiety disorders. Clinicians at a community addictions clinic will~     participate by receiving training in delivering cognitive behavioral therapy for anxiety~     disorders and will deliver the treatment to the patient participants. They will also~     complete some questionnaires. Patient participants will be asked to complete a baseline~     assessment. Those who are eligible will be randomly assigned to one of the two treatment~     groups. Those who are assigned to addiction treatment as usual will continue their regular~     care at the Matrix Institute. Participants who are assigned to also receive the anxiety~     treatment will be asked to participate in 6, 90-min treatment sessions and an orientation~     session. All participants will be asked to complete post-treatment and follow-up~     assessments. The assessments should take approximately 1 hour, and the follow-up assessment~     will be completed 6 months after treatment is over. It is hypothesized that those who get~     the additional anxiety disorder treatment will show greater improvement in anxiety and~     substance use outcomes than those who get Intensive Outpatient Program without the anxiety~     disorder treatment.~   "
98748|NCT01764529|"~     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain~     and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused~     by an inherited gene mutation (alteration) called CCM1. There is a wide range of disease~     severity even among family members with this disease, though the natural history has not~     been clearly described for this particular population.~      This study will examine factors that influence disease severity through the collection of~     blood samples, detailed medical histories, physical and neurological exam, and magnetic~     resonance imaging (MRI) of the brain in medical records. The specific goals of this study~     are to:~        1. establish a registry/database of familial CCM cases with detailed clinical data,~        2. perform genetic testing on participant blood samples to identify other genes that may~          influence the development and hemorrhage of CCM lesions, and~        3. determine lesion growth during the study.~   "
98736|NCT01764685|"~     Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+~     individuals than in the general population. HD adversely affects health directly and reduces~     adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive~     impairment. Reduced drinking improves cognitive performance and adherence to ARTs.~     Medications approved in the United States to treat alcohol dependence have a small effect~     size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine,~     has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent~     individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy~     drinkers. The investigators propose to conduct a randomized, parallel-groups,~     placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce~     or stop their drinking. There are three primary hypotheses for this feasibility and~     proof-of-concept study. First, the investigators hypothesize that topiramate-treated~     patients will decrease the frequency of their HD more than placebo-treated patients. Second,~     based on scores from computerized neurocognitive assessments, the investigators hypothesize~     that topiramate and placebo groups will show similar performance on a battery of cognitive~     tests. Third, based on self-reported medication adherence, the investigators hypothesize~     that adherence to ARTs will be greater in the topiramate group than in the placebo group.~     These findings will provide preliminary data to support a more definitive trial of~     topiramate for the treatment of HD in HIV+ heavy drinkers.~   "
98737|NCT01764672|"~     The goal of the study is to use graph theory to examine how the organization of the~     functional brain network may be altered by the administration of methylphenidate. This~     effect is to be compared between methylphenidate intake and placebo intake, as well as~     between healthy adult males and adult males with a diagnosis of Attention Deficit~     Hyperactivity Disorder.~   "
98738|NCT01764659|"~     The primary objective is to study the feasibility and efficacy of individually optimized CE~     4D-CT for PDA in radiotherapy simulation.~   "
98739|NCT01764646|"~     RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and~     effective than standard radiation therapy in treating prostate cancer.~      PURPOSE: This protocol presents a randomised phase II study aiming to investigate the~     tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate~     cancer.~   "
98740|NCT01764633|"~     The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used~     in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of~     cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or~     coronary revascularization in subjects with clinically evident cardiovascular disease.~   "
98741|NCT01764620|"~     The purpose of this study is to investigate the effects of muscle fatigue in the scapular~     kinematics of overhead athletes with and without using a kinesio taping technique for~     facilitating lower trapezius function. The hypothesis is that the taping technique could~     compensate for the negative effects caused by muscle fatigue in the scapular kinematics of~     healthy overhead athletes.~   "
98742|NCT01764607|"~     Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in~     contrast to the general population with basal and squamous cell skin cancer. The use of~     immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase~     the risk of developing certain kinds of cancer. The purpose of this study is to find out how~     well Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal~     transplant patients.~   "
98743|NCT01764594|"~     To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.~   "
98744|NCT01764581|"~     ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing~     immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of~     immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression.~     The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of~     lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust~     immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse~     events~   "
98745|NCT01764568|"~     Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial~     adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This~     randomized control trial seeks to contribute to the body of evidence supporting psychosocial~     treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive~     remediation (CR) at treating the persistent positive and cognitive symptoms of~     schizophrenia. MCT is a therapy designed to improve patient awareness and insight into the~     cognitive biases that are frequently seen in schizophrenia; it has been associated with~     decreased psychopathology (specifically decreased positive symptoms) and improved~     psychosocial function. CR is a therapy designed to improve performance in a variety of~     neurocognitive functions such as attention, memory, and executive functioning; it has been~     associated with improved cognitive and psychosocial functioning. Both MCT and CR will be~     compared to treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al.,~     2011).~      Hypotheses:~        1. MCT will produce greater change in delusions (severity and conviction) than CR and TAU.~        2. CR and MCT will produce greater change in social/everyday functioning than TAU.~        3. CR will produce greater improvement in basic attention and memory measures relative to~          MCT and TAU.~        4. MCT will produce greater reduction on tasks measuring targeted reasoning biases~          relative to CR and TAU.~        5. CR will increase efficiency of functional networks on a working memory task relative to~          MCT and TAU.~        6. MCT will lead to a greater decrease in the neural response to evidence matches relative~          to CR and TAU.~   "
98746|NCT01764555|"~     This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients~     versus normal weight patients. Specifically the different metabolic pathways of~     acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and~     CYP2E1 (cytochrome P450 2E1) oxidation~   "
98747|NCT01764542|"~     The purpose of this study is to study development of dysplasia in the ileal mucosa among~     patients with Ulcerative Colitis and who previous have hade risk factors for developing~     cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.~   "
98749|NCT01764516|"~     This study was carried out with the purpose of evaluating zinc and selenium levels in serum~     of epileptic patients and compare with normal individuals.~   "
98750|NCT01764503|"~     Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors~     occurring in the small intestine. The symptoms are usually non specific or due to~     pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients~     during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a~     screening procedure in patients with Familial Adenomatous Polyposis (FAP).~      It has been demonstrated that ampullary adenomas have a malignant potential mimicking the~     adenoma-adenocarcinoma sequence already described in the colon. So, a complete removal is~     mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia~     (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the~     situation can be stable during several years leading to simple, annual or biannual~     surveillance. Historically, the treatment was surgical, associated with a high mortality and~     morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal~     resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients~     with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by~     laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation~     especially in case of en-bloc resection. This technique has been increasingly used in the~     last decade with very promising results. Nevertheless the long-term results have mainly been~     reported in retrospective monocentric series.~      We intended to evaluate, in the first large multicenter prospective study, the long-term~     results of endoscopic papillectomy.~   "
98751|NCT01764490|"~     Main objective: to observationally assess the efficacy of different antimicrobials in~     Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases.~      Specific objectives:~      Bacteraemic infections due to ESBL-producing Enterobacteriaceae:~        -  To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure~          rate and mortality than carbapenems after controlling for confounders, both as~          empirical and definitive therapy.~        -  To demonstrate that fluoroquinolones as definitive therapy are not associated with~          worse cure rate and mortality than carbapenems after controlling for confounders.~        -  To demonstrate that empirical cephalosporins in monotherapy are associated with worse~          cure rate and mortality than carbapenems after controlling for confounders in~          infections others than urinary tract infections.~        -  To demonstrate that the association of active aminoglycosides with cephalosporins or~          fluoroquinolines is not associated with worse cure rate and mortality than carbapenems~          after controlling for confounders.~        -  To demonstrate that combination empirical and definitive therapy is not associated with~          better cure rate than monotherapy after controlling for confounders.~        -  For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide~          adjusted estimations of their association with outcome variables in comparison with~          carbapenem monotherapy according to clinical situation and infection.~      Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae:~        -  To demonstrate that combination therapy is associated with worse cure rate and~          mortality than monotherapy after controlling for confounders.~        -  To show that carbapenems are associated with worse cure rate and mortality when used in~          infections other than urinary tract caused by isolates showing MIC <2 µg/mL for~          imipenem or meropenem in comparison to those caused by isolates with higher MIC, after~          controlling for confounders.~        -  To show that colistin used at a dose >6 million IU per day is associated with improved~          outcomes in comparison with lower dose, after controlling for confounders.~   "
98752|NCT01764477|"~     Laboratory studies suggest that the study drug may stop cancer cells from growing by~     affecting an interaction between proteins in the cells referred to as cAMP-response~     element-binding protein and ß-catenin.~      The purpose of this research study is to determine the highest safe dose of study drug that~     may be used when it is given together with a chemotherapy drug to patients with cancer of~     the pancreas.~   "
98753|NCT01764464|"~     Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)~   "
98754|NCT01764451|"~     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain~     and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs~     affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its~     contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of~     this barrier can cause disease. We will measure the permeability (leakiness) of the BBB~     using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI~     (DCEMRI). The purpose of this study is to look at whether statin medications change the~     permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are~     used to lower cholesterol levels and prevent heart attack and stroke. In addition, this~     medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This~     study will examine whether the permeability of the BBB changes following the administration~     of simvastatin for three months.~   "
98755|NCT01764438|"~     Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the~     initial staging workups of definite HCC patients with very early or early stage disease, but~     with no suspicious intrahepatic HCC lesions by liver dynamic CT.~   "
98756|NCT01764425|"~     Clinical trial to study the safety tolerability, pharmacokinetics, food effect and~     pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects~   "
98757|NCT01764412|"~     Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron~     stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.~      The interpretation of hepcidin dosage results requires to know the physiological variations~     of this hormone.~      This study investigate whether there are significant variations in the values of serum~     hepcidin rates during the menstrual cycle in order to make recommendations on the practical~     dosage determination of hepcidin in premenopausal women.~   "
98758|NCT01764399|"~     Older adults caring for others often neglect their own health. This research is being done~     to see if helping caregivers focus on their own needs can improve their health and ability~     to care for others~   "
98759|NCT01764386|"~     The purpose of this Phase 3b study is to assess the effects of combination therapy with~     naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle~     intervention (CLI) and in a manner consistent with its intended use after marketing~     approval, on body weight and cardiovascular risk factors compared to the effects of Usual~     Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or~     obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue~     treatment at Week 16. Subjects are to be discontinued from full participation if they do not~     lose at least 5% of their body weight relative to baseline and/or are experiencing sustained~     increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26,~     subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects~     assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment~     period).~   "
98760|NCT01764373|"~     This is an amendment to study posting NCT00970060. Based on preliminary results from that~     study is was determined there needs to be a follow-up exercise intervention study. This~     study has two additional aims than the original study. The objectives are to determine is a~     prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness~     positively impact people with diabetic neuropathy.~   "
99017|NCT01761032|"~     In the proposed study, the investigators will assess the brain's dopamine response to UVR~     light in individuals who use tanning beds both frequently and infrequently.~   "
98761|NCT01764360|"~     Kaposi sarcoma (KS) is an AIDS-related cancer and is the most commonly reported cancer in~     Zimbabwe. If it is found early on, it may be treatable with antiretroviral therapy (ARVs)~     alone and this will improve general well-being and ease of care. It may also be possible to~     avoid use of expensive chemotherapy if the KS is picked up early on in the course of the~     disease. Early KS is often overlooked or not recognized by health professionals. The purpose~     of the study is to learn more about if the level of medical care and treatment provided at~     primary care clinics in Zimbabwe will help people with AIDS-KS do better and maintain their~     health longer. This will be done by monitoring how KS is diagnosed and treated at the~     primary care clinics. Clinics will then have training in how to recognize and treat KS so~     that they can better identify and care for patients with the disease.~   "
98762|NCT01764347|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound~     (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with~     prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy~     may help find and diagnose prostate cancer~   "
98763|NCT01764334|"~     Background: In patients with acute non-ST elevation myocardial infarction (NSTEMI) coronary~     arteriography is usually recommended however visual interpretation of the coronary angiogram~     is subjective. A complementary diagnostic approach involves measuring the pressure drop~     across a coronary stenosis (fractional flow reserve, FFR) with a pressure-sensitive~     guidewire.~      Hypothesis: Routine FFR measurement is feasible in NSTEMI patients and has additive~     diagnostic, clinical and health economic utility, as compared to angiography-guided standard~     care.~      Design: A prospective multi-center randomized controlled trial in 350 NSTEMI patients with~     ≥1 coronary stenosis ≥30% severity (threshold for FFR measurement). Patients will be~     randomized immediately after coronary angiography to the FFR-guided group or~     angiography-guided group (FFR measured, not disclosed). All patients will then undergo FFR~     measurement in all vessels with a coronary stenosis ≥30% severity. FFR will be measured in~     culprit and non-culprit lesions in all patients. FFR will be disclosed to guide treatment in~     the FFR guided-group but not disclosed in the 'angiography-guided' group. In the FFR-guided~     group, an FFR>0.80 will be an indication for medical therapy whereas an FFR≤0.80 will be an~     indication for revascularization by percutaneous coronary intervention (PCI) or coronary~     artery bypass surgery (CABG), as appropriate. The primary endpoint is the between-group~     difference in the proportion of patients allocated to medical management compared to~     revascularization. A key secondary composite outcome is the occurrence of cardiac death or~     hospitalization for myocardial infarction or heart failure. Other secondary outcomes include~     quality of life, hospitalization for unstable angina, coronary revascularization or stroke,~     and healthcare costs. Exploratory analyses will also assess the relationships between FFR~     and angiographic lesion characteristics (severity, culprit status). The minimum and average~     follow-up periods for the primary analysis are 6 and 18 months respectively. A secondary~     analysis with longer term follow-up (minimum 3 years) is planned. Screen failures who gave~     informed consent will be entered into a registry.~      Importance: Our developmental clinical trial will address the feasibility of FFR measurement~     in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic~     outcomes.~   "
98764|NCT01764321|"~     This prospective, post marketing, observational, Noninterventional Study (NIS) is designed~     to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients~     treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF)~     inhibitor.~   "
98765|NCT01764308|"~     60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic.~     Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day~     for 24 weeks.~   "
98766|NCT01764295|"~     The purpose of this study is to evaluate the efficacy and safety of DWJ1276~   "
98767|NCT01764282|"~     The purpose of this study is to evaluate the effectiveness of reducing HIV transmission~     among sero-discordant couples by applying comprehensive intervention components.~   "
98768|NCT01764269|"~     In this study, the investigators will prospectively assess fever rates in 24-59 month old~     patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or~     live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive~     these vaccines as part of their routine care can enroll in this study if their parent has~     the ability to receive and send text messages. Children enrolled in this study will be~     observed for an eleven day period starting on the day of vaccine administration via a series~     text messages to their parents.~   "
98769|NCT01764256|"~     This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult~     volunteers to determine if it is safe and if the immune systems of healthy adults respond to~     this vaccine.~   "
98770|NCT01764243|"~     The objective of this study is to evaluate the safety and efficacy as assessed by the~     Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of~     MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate~     Alzheimer's disease.~   "
98771|NCT01764230|"~     Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent~     implications and among the most common is infertility as a result of irreversible gonadal~     damage. This project sets the primary target to verify the protective effect GnRH analogues~     administration to protect ovarian tissue during three different regimens of chemotherapy in~     patients with Hodgkin disease (HD) in reproductive age.~   "
98772|NCT01764217|"~     Observational study based on the routine clinical treatment and diagnostic course, to~     correlate imaging features with outcome objectives. Outcome will evaluated as clinical~     response to the standard treatment and as recurrence and survival in the follow up. The~     study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice~     can predict outcomes following standard treatment.~   "
98773|NCT01764204|"~     To highlight the incidence of adverse reactions of Qingkailing Injection.~   "
98774|NCT01764191|"~     This study has been designed to provide patients suspected of having cardiac sarcoidosis~     (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with~     currently available methods, therefore this project will allow access to 18F FDG PET/CT~     scanning, which may more accurately diagnose the presence of CS. This study will also~     provide additional data to further examine the effectiveness and safety profile of 18F FDG~     for this condition. Accurate and early detection is important to allow for better management~     of CS and improve patient care.~      The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with~     clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety~     and effectiveness of 18F-FDG PET/CT in this patient population~   "
98775|NCT01764178|"~     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan~     co-administration and Livalo fixed combination drug in healthy male subjects.~   "
98776|NCT01764165|"~     This research is being conducted to examine the effects of nasal insufflation of warm and~     humidified air through a small nasal cannula on sleep, breathing pulmonary function, and~     daytime exercise capability.~   "
98777|NCT01764152|"~     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised~     with laboratory-confirmed influenza through a network of hospitals in France~   "
98778|NCT01764139|"~     Vitamin D deficiency has long been linked to musculoskeletal pain, and many other chronic~     disease conditions. Vitamin D is a nutrient that functions as a hormone precursor, and~     wide-ranging health effects are supported by the presence of vitamin D receptors in several~     cell types and tissues of the body (eg, lymphocytes and monocytes, brain, heart, pancreas,~     intestine, and placenta).In addition to its essential role of maintaining bone health,~     hypovitaminosis D has been implicated in the development of serious conditions, including~     diabetes, various types of cancer, and cardiovascular diseases.~      Vitamin D is a unique prohormone that humans obtain in small amount from food, dietary~     supplements and largely by endogenous skin synthesis from 7-dehydrocholesterol with sunlight~     exposure. This endogenous synthesis produces the form vitamin D3 (cholecalciferol).Vitamin D~     deficiency and insufficiency are very common in the UK. Local audit at Chelmsford has shown~     severe deficiency of vitamin D among chronic pain patients.~      The major source of vitamin D synthesis relies on sunlight exposure which is likely to be~     affected by modern lifestyles, which increasingly involve working indoors during daylight~     hours. This may be particularly important when combined with residence in northern latitudes~     and a cloudy climate.The proposed pilot study aims to identify percentage of vitamin D~     deficiency among knee pain patients by investigating eligible patients' blood for '25~     hydroxy vitamin D'.~      English speaking patients whose knee pain has not been resolved following knee arthroscopy~     are eligible for the study. Study will be carried out at the Broomfield hospital chronic~     pain department.~      Duration will be around 6 months.~   "
98779|NCT01764126|"~     This is an observer-blind, randomised, vaccine-controlled, vaccine trial to determine the~     safety and immunogenicity of a pneumococcal protein vaccine. It will use an age step-down~     approach beginning with adults, then toddlers then infants, with data safety review at each~     stage before stepping down to the next age group. Adults and toddlers will receive the same~     dose of this three-protein (trivalent) vaccine (PcpA, PhtD, and PlyD1 proteins) at 50µg~     each. Infants will then be started at a low dose (10 µg), then medium dose (25µg) then high~     dose (50µg), with safety reviews at each stage before ascending to the next highest dose.~     Infants will also receive concomitant standard EPI childhood vaccines. Safety will be~     assessed by close monitoring beginning on the day of vaccination (day 0) and for the~     subsequent seven days, with recording of solicited and non-solicited adverse events.~     Immunogenicity will be assessed by specific antibody response to the three proteins. The~     study aims to recruit 280 study subjects across all age groups.~   "
98780|NCT01764113|"~     This study is designed to study the effect of a family based mindfulness training program~     with special focus on diet and nutrition on weight and cardiovascular risk markers in obese~     adolescents.~   "
98781|NCT01764100|"~     This is a bicentric, prospective, non randomized study. Pediatric and adult patients will be~     treated.~      Rationale: MSC have shown promising effects by reversal of severe therapy-resistant acute~     GvHD. As a common therapeutic line of action is not shared for steroid resistant GVHD, it is~     important to establish the toxicity and the feasibility of preparation and infusion of third~     party MSCs for acute steroid resistant GVHD and acute phases of chronic steroid resistant~     GVHD.~      A total of 10 patients (pediatric and adults) need to be enrolled in the study. Patients who~     present clinical signs of either acute or chronic steroid resistant GVHD will receive by~     intravenous infusion at least two fixed doses of mesenchymal stem cells with 5 to 7 days of~     interval one from the other, derived from HLA unrelated donor different from the HSC donor~     (third party donor) regardless of the rate of HLA mismatch.~      Primary objectives are to establish the feasibility and the toxicity of preparation and~     infusions of third party MSCs for the treatment of steroid resistant acute and acute phases~     of chronic grade II-IV GVHD.~      Secondary objectives are:~        1. To document the efficacy of MSC infusion in steroid resistant acute and acute phases of~          chronic GVHD grade II-IV.~        2. To document the rate of GVHD recurrence in MSCs infused patients.~        3. To document relapse of hematological malignancies post MSC infusions in patients~          undergoing MSCs treatment for steroid refractory GvHD.~        4. To document the overall survival of MSC infused patients for steroid refractory GvHD.~   "
98782|NCT01764087|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) of~     KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391~     in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer,~     respectively in Phase II.~   "
98783|NCT01764074|"~     Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of~     depression and (hypo)mania. These episodes are associated with poor functioning, worse~     course of illness, and high rates of suicidality. It is estimated that between 25 to 65% of~     individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by~     suicide. Sleep disturbance has been identified as a primary prodromal as well as causal~     symptom of mood episodes and recently, has been found to be associated with higher rates of~     suicidal ideation and behavior. Given the role that sleep may have in mood stability and~     suicidality in BD, it seems imperative to further understand the association of sleep and~     suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the~     primary aim of this study is to use an innovative home sleep monitoring device, or the~     Embla, to examine the association of sleep and suicidality in adult outpatients with BD. The~     Embla is unique in that it is a non-invasive device that can characterize sleep profiles by~     measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM)~     sleep. The study duration is five to six weeks such that patients wear the Embla device for~     Week 1, participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4,~     and then wear the Embla device for one more week (Week 5). This intervention consists of~     three, 60-min sessions and utilizes cognitive-behavioral therapy strategies (e.g.,~     psychoeducation, cognitive re-structuring, problem solving, behavioral activation) to~     improve sleep disturbance. The investigators expect that individuals at study entry with~     more sleep disturbance (as measured by the Embla) will report more suicidal ideation and~     behaviors. The investigators also hypothesize that from pre- to post-intervention,~     individuals will report less sleep disturbance as well as suicidal ideation and behaviors.~     Data from this research has immediate and practical implications for providers and their~     patients as it the first examination of sleep phenotypes and suicide in a high risk~     population as well as to explore the association of improvements in sleep with suicidality.~   "
98784|NCT01764061|"~     The purpose of this study is to validate that single units of RBCs collected by the~     Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red~     cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood~     cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using~     LN832 disposable sets for this intended use.~   "
98810|NCT01763723|"~     This studies was designed to investigate the importance of skin type and UV-exposure on side~     effects after exposure to an Intense Pulsed Light Home-use device.~      21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly~     IPL-exposures.~   "
99639|NCT01752907|"~     The purpose of this study is to determine if patient education can affect patient reported~     bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.~   "
98785|NCT01764048|"~     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for~     the mother to nurture the newborn child and establishing an appropriate mother-child~     bonding. Therefore, effective pain management is crucial. In this study we would like to~     compare between two pain relievers' administration protocols: (1) pain relievers'~     administration in fix protocol (type of medications, dose and intervals) or (2) pain~     relievers' administration following demand (the same type and doses, however, medications~     will be given only following patient's request).~      The primary outcome will be patient satisfaction, pain control and the necessity of~     additional medications (rescue doses).~      The protocols will be used for the first 48 hours following surgery.~   "
98786|NCT01764035|"~     The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS)~     meditation intervention for individuals with bipolar I disorder with insomnia (i.e.~     difficulties falling or staying asleep). The investigators will compare the Body Scan~     intervention with a 4-session brief supportive psychotherapy (SP) intervention. The~     investigators hypothesize that the Body Scan will improve objective sleep quantity and~     quality.~   "
98787|NCT01764022|"~     BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN:~     trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast~     cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the~     non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes~     pharmacokinetics assessment.~   "
98788|NCT01764009|"~     The objective of the present trial is:~        -  to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and~          recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in~          patients with advanced or metastatic melanoma.~        -  to determine the local and general safety of intramuscular electrotransferred Plasmid~          AMEP~        -  to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP~   "
98789|NCT01763996|"~     The purpose of this study is to assess the effect of febuxostat on coronary artery flow in~     patients with coronary artery disease.~   "
98790|NCT01763983|"~     High levels of psychological stress have been reported by 90% of patients with MS~     experiencing disease exacerbation, and approximately 39% of those with more stable disease~     course. These stress levels are comparable to patients with a clinical diagnosis of major~     depression. Cognitive dysfunction affects approximately 40% of community surveyed MS~     patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive~     Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also~     shown that exercise is beneficial to mood and cognitive function. Therefore the proposed~     study will test the comparative benefits of combining CBT and Exercise as an intervention~     for stress and cognitive dysfunction in MS subjects. The 2 active treatment conditions will~     be compared with a waitlist control condition.~      There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise,~     and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological~     features of stress and MS, especially working memory and executive functioning, improve~     following treatments, 3) to determine the extent to which neuropsychological factors are~     associated with successful treatment response and improved quality of life, and 4) to~     determine if combined CBT-Exercise confers greater benefits on measures of stress and~     neuropsychological functioning compared with Exercise alone.~      The study hypotheses are: 1) All active treatment conditions will lead to significantly~     greater improvement on measures of stress at post-treatment and follow-up compared to~     waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom~     reduction compared to all other conditions at post-treatment and follow-up assessments on~     measures of stress, 3) All active treatment conditions will lead to significant improvement~     in neuropsychological functioning (particularly measures of working memory and executive~     functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead~     to greater improvement in neuropsychological functioning compared to all other conditions at~     post-treatment.~      The study design allows for examination of the potential additive benefits of CBT and~     Exercise to usual therapy for patients, and its feasibility as a viable treatment model for~     MS outpatient clinics and community-based intervention programs. This study will shed light~     on the treatment of sub-threshold symptoms that are strikingly common in MS population, but~     often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This~     proposed study will also be the first to determine whether evidence-based non-medical~     treatments for stress and mood disturbances in MS reduce underlying cognitive substrates~     associated with the illness and known to be exacerbated by stress.~   "
98791|NCT01763970|"~     The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in~     the adult population. However, SBRT (stereotactic body radiation therapy) has a particularly~     strong rationale for application in pediatrics given that high biologically effective doses~     have been shown to increase control in histologies, such as sarcoma, which are common in the~     pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction~     in normal tissue dose surrounding the target lesion of interest may also be accomplished~     resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with~     limited metastases in lung and bone, are still considered to be a curable population with~     aggressive local therapy, SBRT could have a significant impact on outcomes in~     oligometastatic patients who may be otherwise unresectable (25-28).~   "
98792|NCT01763957|"~     The Investigators decided to examine whether the Paula method is more effective than Pelvic~     Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test~     in menopause women without an hormonal therapy. In addition to the pad test and two urinary~     incontinence questionnaires, we will use other assessment tools such as; quality of life and~     sexual function which have been found to correlate significantly with pad test results.~     These results may indicate that menopausal women with Stress Urinary Incontinence may be~     more successful controlling incontinence if they will practice the Paula method as compared~     to PFMT.~   "
98793|NCT01763944|"~     No treatments have been shown to slow prostate cancer progression after radical~     prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer~     growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary~     treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams~     carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome~     is PSA doubling time.~   "
98794|NCT01763931|"~     The purpose of this study is to learn what effects digoxin may have on human breast cancer~     tissue.~   "
98795|NCT01763918|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously~     once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change~     from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous~     familial hypercholesterolemia (HeFH).~   "
98796|NCT01763905|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab~     every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from~     baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults~     unable to tolerate an effective dose of a statin (HMG-CoA~     (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).~   "
98797|NCT01763892|"~     The aims of this study explore the relationships between cerebral vasospasm,~     apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that~     may either intensify or ameliorate secondary injury, for children with a traumatic brain~     injury. Exploring the apo-E genotype will help us know if injury response is altered in~     certain children and will aid in developing interventional approaches.~   "
98798|NCT01763879|"~     The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for~     thoracic surgery is associated with comparable oxygenation with volume controlled~     ventilation (VCV) with added benefits of decreasing airway pressures and shunt fraction. The~     later may improve the right ventricular (RV) function during OLV. We postulate that the use~     of PCV during OLV for thoracic surgery would preserve RV function than during VCV. After~     local ethics committee approval and informed consent, we will randomly allocate 28 patients~     scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14~     for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment~     maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative~     changes in the right ventricular function (peak systolic and diastolic tricuspid annular~     velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional~     area changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway~     pressures, compliance will be recorded.~   "
98799|NCT01763866|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab administered~     subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin,~     compared with placebo, on percent change from baseline in low-density lipoprotein~     cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.~   "
98800|NCT01763853|"~     The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress~     syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon~     that the intensivist must recognize early and treat promptly. Fluid challenge may have~     adverse side effects associated with fluid administration. The diffusion within the~     interstitial space may favor edema formation and cause cardiac dysfunction by volume~     overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial~     integrity, leading to enhanced alveolar edema and impaired gas exchange.~      Currently, two types of fluids are frequently used, crystalloids and colloids. Among~     colloids and compared to crystalloids, albumin has the theoretical advantage of causing~     greater volume expansion.~      We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary~     edema than a fluid resuscitation therapy with crystalloids.~      The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema~     fluid resorption, in 2 groups of patients: those treated with albumin and those treated with~     crystalloid.~   "
98801|NCT01763840|"~     The research protocol aims to compare the utility of contrast enhanced abdominal sonography~     with computerized tomography in the evaluation of children with blunt abdominal trauma.~     Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the~     trauma service with a CT scan of abdomen & pelvis already performed at the referring~     institution will be identified by the trauma service as eligible for inclusion.~      The ultrasounds will be performed by one of two Attending Radiologists involved in the~     study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ),~     which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been~     used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric~     abdominal and pelvic solid tumors. The contrast enhanced ultrasound will be performed by~     radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore~     Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital~     signs will be monitored for 30 minutes after the contrast agent is given and any adverse~     reactions will be recorded. Adverse reactions to Optison have occurred within this time~     frame in the literature. Subsequent medical care will be as indicated per the clinical~     practice guideline.~   "
98802|NCT01763827|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)~     monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on~     percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a~     10-year Framingham risk score of 10% or less.~   "
98803|NCT01763814|"~     Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of~     three groups, each group will use a different approach using the ultrasound to guide the~     femoral nerve block as part of their treatment for controlling pain post-operatively.~   "
98804|NCT01763801|"~     Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique~     to correctly position the catheter tip. The investigators sought to evaluate the superiority~     of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a~     more correct, safer and longer lasting device placement, with a lower incidence of~     complications and secondary misplacement.~   "
98805|NCT01763788|"~     The purpose of the Phase 1b portion of the study is to investigate how the body tolerates~     necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line~     treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose~     for the subsequent Phase 2 portion of the study.~      The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab~     in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV~     squamous NSCLC in a first-line setting.~   "
98806|NCT01763775|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B,~          BF-1256-B, and GBF-1257-B.~        4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.~        5. Study endpoints: DUT and the comparison device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~   "
98807|NCT01763762|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than pelvic floor muscle training with Transvaginal electrical stimulation in~     treating female stress incontinence.~   "
98808|NCT01763749|"~     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of~     Plavix with Astrix.~   "
98809|NCT01763736|"~     The objective of this research study is to assess the effects of music on patients'~     experience in the Intensive Care Unit (ICU). The hypothesis of this study is that patients~     who receive music therapy will report a reduction in negative recollections and experiences~     while on mechanical ventilation and will require fewer pharmacologic agents to maintain~     their sedation.~   "
105813|NCT01672151|"~     The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune~     Thrombocytopenic Purpura (RITP) and explore the further mechanism.~   "
98811|NCT01763710|"~     Nanomedicines are currently being developed in the treatment of cancer due to their~     pharmacological advantages over traditional formulations; they provide a shorter infusion~     time and lower risks of hypersensitivity reactions associated with commonly used solvents.~      Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought~     to exploit natural albumin pathways to enhance the selective uptake and accumulation of~     paclitaxel at the site of the tumour, thus reducing its diffusion to normal tissues.~      Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who~     have failed first-line treatment for metastatic disease and for whom standard,~     anthracycline-containing therapy is not indicated.~      SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid~     tumours. Expression of this protein could sensitize tumour cells to antitumor activity of~     Nab-paclitaxel, due to its union through albumin-binding to this protein.~      First-line clinical trials have been developed with different Nab-paclitaxel regimens and~     also in combination with different chemotherapies and trastuzumab, showing a high level of~     efficacy.~      Toxicity profile of Nab-paclitaxel is well characterized with significantly less~     haematological toxicities compared with conventional paclitaxel.~      Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than~     conventional paclitaxel-derived neuropathy, probably due to absence of Cremophor solvent, or~     due to paclitaxel itself.~      However there is still a lack of clinical and physiological characterisation of~     Nab-paclitaxel induced neuropathy.~      The current used tools for early detection and continuous evaluation of neurotoxicity are~     not optimal. Most used toxicity scales are limited, as they do not provide a detailed~     information of the severity of the neuropathy, its impact on quality of life, or~     physiopathology mechanisms.~      In addition, an inter-individual variability exists in terms of neurotoxicity predisposition~     when taxanes are used; it could be related to polymorphic differences in genes implicated in~     transport and metabolism of these drugs.~   "
98812|NCT01763697|"~     This study will investigate the effects of acute morphine administration on taste acuity and~     how much a person eats. It is hypothesized that there will be a dose dependent decrease in~     taste acuity and dose dependent increase in food intake associated with acute morphine~     administration. Knowledge from this study will impact the future of feeding behavior and~     obesity research in the general population. Results will also promote exploration of the~     long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing~     populations.~   "
98813|NCT01763684|"~     This study will compare alignment criteria in the Oxford Partial Knee using conventional~     instrumentation and Signature Custom Guides in order to determine if the use of the~     Signature Custom Guides results in a higher percentage of knees achieving optimal alignment.~     The study will also examine outcomes with high volume surgeons (>30 cases/year) and low~     volume surgeons (<10 cases/year).~   "
98814|NCT01763671|"~     The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to~     docetaxel.~      Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by~     numerous clinical trials but sometimes toxicities are difficult to manage.~      Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials~     in association with platinum in first ligne. Different clinical and preclinical data suggest~     that there could exist a synergy between paclitaxel and bevacizumab. This association is~     already used in metastatic breast cancer, it permits almost to double the response rate and~     progression free survival. In lung cancer, the association was evaluated by two~     retrospective studies which demonstrated a benefit with a favourable safety profile.~   "
98815|NCT01763658|"~     Oxidative stress occurs as a result of increased activity of free radical-producing enzymes,~     decreased activity of free radical-removing enzymes, and insufficient levels of~     antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane~     elasticity, increased cell fragility, and a shortened cellular life span results from~     oxidation of cell membrane lipids.~   "
98816|NCT01763645|"~     BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN:~     bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in~     inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The~     purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021~     compared to Avastin. Also study includes pharmacokinetics assessment.~   "
98817|NCT01763632|"~     Thirteen hospitals in China will participate in the study, which aims to provide data on~     transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and~     late-preterm neonates, and develop an hour-specific TcB nomogram.~      The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal~     hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up~     for hyperbilirubinemia in newborns.~   "
98818|NCT01763619|"~     This study will collect clinical and radiographic data on the Freedom Cervical Disc to~     monitor the device's safety and performance as part of a post-market evaluation.~   "
98819|NCT01763606|"~     Patients with cancer who develop stroke are at high risk for future strokes or other~     clotting events. These patients are routinely treated with medicines that thin their blood,~     including enoxaparin or aspirin. However, it is unclear which medicine is best and whether~     these medicines can be adequately studied in a clinical trial.~      The purpose of this Phase I/II study is to determine if a clinical trial of different blood~     thinners in patients with cancer and stroke is possible. In addition, the study aims to~     compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with~     cancer and recent stroke.~   "
98820|NCT01763593|"~     To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by~     Aurolab.~   "
98821|NCT01763580|"~     To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid~     with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.~   "
98822|NCT01763567|"~     The purpose of this study is to assess safety and device performance of the Medtronic~     Hospital Glucose Management System (HGMS) for up to 72-hours.~   "
98823|NCT01763554|"~     Review of the medical files of 69 patients with neuroendocrine tumours who were treated at~     the CCI from January/10 - July/12 with Lutetium-177 DOTA-TATE under Health Canada's Special~     Access Programme (SAP). Efficacy, safety, and other relevant data will be collected.~   "
98908|NCT01762449|"~     The primary intent of this study is to add to the body of knowledge on scleroderma patients~     with interstitial lung disease. While lung disease is recognized as the leading cause of~     death amongst patients with scleroderma, there is not a large body of literature describing~     the long-term morbidity and mortality rate of these scleroderma patients. For this reason,~     the investigators are following participants of the Scleroderma Lung Study (NCT00004563)~     after their participation in that study was concluded. In addition, the investigators will~     assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma~     Lung Study experienced progression of their scleroderma-related lung disease following the~     end of the study.~   "
139675|NCT01226602|"~     The purpose of this study is to determine if Ticagrelor increases the Adenosin induced~     coronary blood flow velocity.~   "
98824|NCT01763541|"~     There is gender dimorphism in cardiovascular risk, with men at higher risk than women.~     However, the fundamental basis for the protective effect of female sex remains unclear.~     Recent data implicate the natriuretic peptide (NP) system as an important determinant of~     blood pressure. Also, NP levels are twice as high in women of reproductive age than in men,~     and gonadal steroids are important determinants of circulating NPs. These are the marked,~     but poorly understood differences in the NP status between men and women. The investigators~     hypothesize that gonadal steroids regulate NP release, specifically that testosterone~     inhibits and estrogen activates the NP axis, leading to differences in both resting NP~     levels and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading.~     Understanding the basis for gender differences in NP function should provide important~     insights regarding mechanisms underlying hypertension in men versus women.~   "
98825|NCT01763528|"~     The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP~     among overweight and obese women.~   "
98826|NCT01763515|"~     Knee osteoarthritis is a common problem with the disease prevalence increasing with~     advancing age. This study will be performed in the purpose of determination the effects of~     laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.~   "
98827|NCT01763502|"~     Recent evidence shows that early childhood is a critical period for investments in human~     capital and that micronutrient deficiency and inadequate stimulation are major causes of~     impaired child development in poor countries. These findings have increased interest in~     promoting nutrition interventions and preschool participation during early childhood.~     Transfers to households linked to preschool participation have the potential to improve~     nutrition and cognitive outcomes in young children. Receipt of transfers may induce~     improvements in diet quality and greater preschool participation, enhancing both nutrition~     and stimulation. However, there is limited evidence on the impacts of such programs, all of~     it from Latin America. There is also no evidence on the relative impact of different~     transfer modalities linked to preschool participation.~      This study is a cluster-randomized controlled evaluation of a transfer program linked to~     preschool participation. The transfer program, administered by the World Food Programme,~     provides food or cash transfers to children aged 3-5 years enrolled in preschools at~     baseline. The preschools, operating in the Karamoja sub-region of Uganda, are supported by~     UNICEF and managed by District representatives of the Government of Uganda. The food~     transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar,~     totaling approximately 1200 calories per day per child and including 99% of iron~     requirements. Cash transfers equal the estimated value of the food basket if purchased in~     the market. Randomization into the food treatment, cash treatment or control was done across~     98 preschools, referred to as Early Childhood Development (ECD) centers. The intervention~     period was from February 2011 to May 2012 and included distribution of transfers on a~     six-to-eight-week cycle. A longitudinal (panel) survey of households with children aged 3-5~     years at baseline was conducted before exposure to the transfers and 18 months later. The~     randomized design of this effectiveness study and the panel nature of the data allow for a~     rigorous field trial in which impacts on nutrition and cognitive outcomes can be assessed~     and compared across modalities.~      We examine the impacts of the two transfer modalities, cash transfers or~     multiple-micronutrient-fortified food transfers, linked to preschool enrollment, on child~     nutrition and cognitive development. In addition, we explore potential mechanisms through~     intermediate impacts on food intake and participation in preschools.~      The key research objectives are to assess the following:~        1. Impacts on targeted groups: Assess the effects of cash or food transfers on nutrition~          and cognitive outcomes in children aged 3-5 years at baseline and explore pathways for~          these effects.~        2. Optimal program design: Assess the differential impacts of a program in which children~          are provided multiple-micronutrient-fortified food transfers linked to preschool~          enrollment compared with one in which they are given the equivalent value of cash~          transfers linked to preschool enrollment.~   "
98828|NCT01763489|"~     Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability~     of a surgery trial to improve the translation of research to practice.~      Objective: To evaluate the impact of the ASSIST tool on the interpretation of the~     applicability of randomized controlled trials (RCTs) in the field of digestive cancer~     surgery.~      Design: This study is a randomized controlled trial with two parallel arms. Participants:~     Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for~     international scientific journals of surgery (Annals of Surgery, Archives of Surgery,~     Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).~      Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case~     vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate~     the same case vignette with the representation of the external validity of the trial with~     ASSIST tool.~      Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they~     feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons~     and 4) intervention.~      Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been~     developed and evaluated. The inclusion of 130 participants (65 per arm) is required.~   "
98829|NCT01763476|"~     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience~     with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number~     of these patients could be helped through medication or surgery. In fact within the first~     year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90%~     have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA~     for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of~     cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to~     1-year primary patency rates up to 30%.~      The primary objective of this study is to compare the performance of atherectomy followed by~     a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo~     infrapopliteal lesions in a prospective, single-center, randomized clinical trial.~   "
98830|NCT01763463|"~     Pneumonia remains an important cause of morbidity and mortality in older adults with~     obstructive lung disease. Risk factors for pneumonia, including episodes associated with a~     hospital admission, have been extensively characterized in clinical trials and observational~     studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior~     COPD exacerbations, dyspnea , normal to low body mass index (<25), current smoking and~     certain co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has~     also been identified, as associated with an increased risk of pneumonia in patients with~     COPD.~      The primary objective of this study is to estimate the magnitude of known risk factors and~     the outcomes of pneumonia requiring hospitalization and the potential effect modification of~     these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as~     community-acquired pneumonia (CAP) resulting in hospitalization and/or death and~     hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary~     endpoint, CAP that did not result in hospitalization or death will be examined. As a~     secondary objective, we will describe characteristics for those patients who develop~     pneumonia requiring hospitalization compared to those with pneumonia not requiring~     admission.~      This study will use the General Practice Online Database (GOLD), formerly referred to as the~     General Practice research Database (GPRD), a primary care electronic medical record~     database.~      A new user cohort will be defined among patients with COPD who are 45 years and older in the~     United Kingdom. Patients will be considered a new user of ICS-containing medications if they~     had not received a prescription for an ICS-containing medication in the prior year. The~     comparator treatment group will be new users of long-acting bronchodilators (LABD),~     including long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one~     year washout period, all new users could not have either ICS-containing medications or LABD.~      Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the~     number of pneumonia events and the number of new users separately to examine the available~     precision based on the study design.~      Patients will be followed from the date of their first eligible prescription (Cohort Entry~     Date) until the earliest of the following: date of study end point (first pneumonia event of~     interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of~     transfer to a new practice, date of ICS initiation (among LABD new users), death or study~     end (end of available data). As part of the primary analysis, patients will be examined for~     their first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe~     CAP will be examined. Incidence rates of the pneumonia outcomes will be calculated as the~     number of patients experiencing an event divided by the person-years at risk.~      Multivariable analysis will be performed using Cox proportional hazard model with adjustment~     for confounders and medication exposure. To adjust for differences confounding by severity~     due to differences in prescribing between ICS-containing medications and LABD, propensity~     scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The~     propensity score will be estimated to model the probability of a patient receiving~     ICS-containing medication prescription versus receiving a LABD prescription given a~     patient's observed set of baseline covariates.~      Effect modification (statistical interaction) will be evaluated based on available theory~     and include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI~     ≥25, age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current~     smoking status, social deprivation quartiles). Additional interactions may be evaluated.~      To test proportionality of the hazard functions, model diagnostics will be performed.~      To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics~     of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess~     differences between treatments, clinical and patient characteristics will be compared using~     the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively.~     Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be~     considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs.~     HAP.~      Additional analysis or adjustments to the analytic or modeling strategy will be performed if~     the data warrants. A more detailed modeling strategy, including generation of the propensity~     scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a~     priori plan will be described in the final study report.~   "
98831|NCT01763450|"~     A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus~     Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously~     untreated unresectable liver metastases from colorectal cancer.~   "
98832|NCT01763437|"~     The investigators propose a study to investigate the role of tetracycline injection into~     chalazia versus observation alone. The investigators hypothesize tetracycline injection will~     result in a significant decrease in lesion size when compared to observation alone.~   "
98833|NCT01763424|"~     This study will determine if combination of topical calcipotriol and nicotinamide is more~     effective than calcipotriol alone in treatment of psoriasis.~   "
98834|NCT01763411|"~     This retrospective study comprised patients with cataract, corneal astigmatism, and~     motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular~     Lens was been implanted in the capsular bag. Three months postoperatively, distance,~     intermediate, and near visual acuities; spherical equivalent; residual refractive~     astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction~     and visual phenomena questionnaire was also been administered.~   "
98909|NCT01762436|"~     β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on~     sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent~     cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and~     atenolol on SNA and CAP in hypertensive patients.~   "
98835|NCT01763398|"~     The domestic standards of G-CSF permit the use of the G-CSF only when the ANC(absolute~     neutrophil count) drops to 1,000/uL or below. Therefore it is impossible to inject the G-CSF~     in order to prevent neutropenia. However, 'the 2006 Update of Recommendations for the Use of~     White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline(J ClinOncol~     2006; 24:3187-3205)' and the 'NCCN Guideline' have revealed that as a precaution, it is~     appropriate to inject the G-CSF to the non-Hodgkin's lymphoma patients with high-risk~     factors under the anticancer treatment of CHOP-21 Rituximab before the number of neutrophils~     decreases. Thus, it is intended to analyze the risk factors of febrile neutropenia in a~     high-risk group of non-Hodgkin's lymphoma patients with a neutropenic fever who receive the~     CHOP-like regimen and primary G-CSF prophylactic therapy every three weeks. (The definition~     of neutropenic fever is a fever over 38.3 degrees C or continuous fever lasting longer than~     1 hour over 38 degrees C with the number of neutrophil ≤ 500/uL or neutrophil ≤ 1,000/uL in~     case of expected decline to ≤ 500/uL within 48 hours.)~   "
98836|NCT01763385|"~     This project is aim to explore non-increased-intracranial-pressure symptomatic brain~     metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with~     Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are~     treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and~     continued to take Erlotinib till extracranial lesions progression. Control group are~     Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after~     radiotherapy until recurrence or termination for other reasons.~   "
98837|NCT01763372|"~     The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas~     release. To complete this aim, we will recruit patients who have undergone arthroscopic~     iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as~     their own control. To delineate the effects of arthroscopic surgery alone from those~     resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a~     second control group consisting of patients who have undergone arthroscopic surgery by Dr.~     Aoki without iliopsoas release.~      For both hips of each subject, we will:~        -  Quantify the muscle volume of the iliopsoas muscle with MRI.~        -  Quantify hip flexion strength with isokinetic dynamometry.~        -  Quantify patient function and satisfaction with functional outcome surveys.~      This data will allow us to test the following hypotheses:~        -  Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have~          decreased iliopsoas muscle volume and hip flexion strength.~        -  Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips~          undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and~          hip flexion strength.~        -  Patient function and satisfaction positively correlates to muscle bulk and strength.~   "
98838|NCT01763359|"~     The purpose of this prospective study is to compare hip adductor strength and obturator~     nerve palsy between acetabular fracture patients whose fracture was reduced and fixated~     using the modified Stoppa approach (subjects) and pelvic fracture patients (controls) using~     physical strength testing, radiographs, clinical assessment, and a validated functional~     outcome questionnaire. The investigators' research hypothesis is that there will be less~     strength and higher incidence of obturator nerve palsy in patients treated with the modified~     Stoppa approach (intervention) than in patients treated without the modified Stoppa approach~     (controls).~   "
98839|NCT01763346|"~     Weight loss achieved through gastric banding will be superior to treatment with metformin in~     preserving or restoring pancreatic beta cell function in people with prediabetes or mild~     type 2 diabetes.~   "
98840|NCT01763333|"~     To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability~     of BI 1026706~   "
98841|NCT01763320|"~     Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent~     stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment,~     however, the results of this trial, its inclusion criteria and its center selection received~     significant criticism and did not appear to reflect our experience, neither regarding~     natural history, nor treatment complications rate. As ICAS is the most common cause for~     stroke in Asian countries, we are hereby proposing a refined prospective randomized~     multicenter study in an Asian population with strictly defined patient and participating~     center inclusion criteria.~      The China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS)~     trial, is an ongoing, government-funded, prospective, multicenter randomized trial. It~     recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major~     intracranial artery. Patients with previous stroke related to perforator ischemia will not~     be included. Only high-volume center with a proven track record will enroll patients as~     determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy~     alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30~     days after enrollment or after any revascularization procedure of the qualifying lesion~     during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond~     30 days The CASSISS trial will be conducted in 8 sites in China with core imaging lab review~     at a North American site and aims to have a sample size of 380 subjects (stenting, 190;~     medical therapy, 190). Recruitment is expected to be finished by Dec, 2016. Patients will be~     followed for at least three years. The trial is scheduled to complete in 2019. In the~     proposed trial, certain shortcomings of SAMMPRIS including patient and participating center~     selection will be addressed. The present manuscript outlines the rationale and design of the~     study. We estimate that this trial will allow for a critical reappraisal of the role of~     intracranial stenting for selected patients in high volume centers.~   "
98842|NCT01763307|"~     Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic~     colorectal cancer patients.~      This study will prospectively accrue metastatic colorectal patients receiving EGFRI and~     treat with reconval cream half face versus placebo cream half face to study whether Vitamin~     k1 cream can prevent the typical skin eruption caused by EGFRI.~   "
98843|NCT01763294|"~     There is a continuous necessity for the search of new alternatives for safe, affordable and~     effective noninvasive therapies for patients that are not eligible for focal resective or~     palliative surgery. The transcranial direct current stimulation (tDCS) therapy has~     demonstrated to be safe, noninvasive, simple and effective with promising results in case~     series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a~     feasible and low cost method to modify cortical excitability in a non-invasive procedure.~     Its effects on cortical excitability seem to be similar to the effects induced by repetitive~     transcranial magnetic stimulation. The aim of this study is determine the safety and~     efficacy in the reduction of the number of seizures (>50%) and epileptiform activity in~     patients with refractory and multifocal epilepsy after different protocols of tDCS compared~     with placebo.~   "
98972|NCT01761617|"~     A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly~     minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are~     pain intensity and measure of disability; secondary outcomes are pain medication use,~     treatment adherence, and health-related quality of life.~   "
98844|NCT01763281|"~     The investigators have been developing new, non-invasive magnetic resonance imaging (MRI)~     techniques to image the small bowel. Building on those studies the investigators want to~     study, in healthy volunteers, the effects of stress on the water content of the small bowel~     following ingestion of fructose. This is important because in Irritable Bowel Syndrome~     (IBS), there seems to be a strong association of stress and anxiety with the severity of the~     disease. Many IBS patients complain of food intolerances and recent studies have suggested~     that food with high content of fructose can worsen symptoms of IBS. The investigators will~     carry out a study in which the investigators will induce a moderate state of stress in~     healthy volunteers using an injection of corticotrophin release hormone, feed them a drink~     containing fructose and image their bowel at intervals using MRI. Improving our~     understanding of the effects of stress and fructose on small bowel physiology will help us~     to understand better some aspects of the symptoms such as bloating, altered bowel habit and~     abdominal discomfort, experienced by the IBS patients and to guide therapy. The~     investigators hypothesize that the effect of CRH will cause significant decrease in small~     bowel water content (SBWC) and a faster small bowel transit with increased malabsorption~     following consumption of fructose.~   "
98845|NCT01763268|"~     Open-label, single-arm trial, Primary Objectives included:~        1. To assess the immunogenicity of TrivivacTM administered in healthy infants aged between~          9-14 months.~        2. To assess the safety (reactogenicity) of TrivivacTM administered in healthy infants~          aged between 9-14 months.~      The study will be done on healthy infants, 9-14 months of age. After enrolment, the infants~     will be given one dose of primary vaccination MMR (TrivivacTM),SEVAPHARMA BiogenetechLtd.~     study vaccines will be administered subcutaneously into the anterolateral aspect of right~     thigh.outer aspect of the upper arm. Subjects will be followed at approximately 6 weeks~     after primary vaccination to evaluate response to primary immunization of this vaccine.~     Blood sample will be collected from subjects at visit 1 (prior to immunization) and visit 2~     (6 weeksone month after completion of this first dose of immunization). The serum samples~     will be analysed for Anti-measles, Anti-mumps and Anti-rubella antibodies. Proportion of~     subjects achieving seroprotection and geometric mean titers of antibody against measles,~     mumps, rubella at 6 weeks after one dose vaccination of MMR vaccine at aged 9-14 months will~     be evaluated. Adverse reactions will be observed on each vaccination day (up to 30 minutes)~     and for 4 days (Day 0-3) after each dose. Adverse reactions will also be monitored for 30~     days following each vaccination. Serious adverse events will be monitored for the entire~     study duration.~   "
98846|NCT01763255|"~     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can~     involve brain and nervous system functions such as movement, learning, hearing, seeing, and~     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these~     problems occur as the baby grows in the womb, but they can happen at any time during the~     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem~     cells are known as a effective therapy.~      In this study the investigators evaluate the side effect of multiple intrathecal injection~     of bone marrow stem cell in patients with cerebral palsy.~   "
98847|NCT01763242|"~     Aims:~        1. To establish an electronic process for CKD anaemia management using monthly~          synchronized dosing of erythrocyte stimulating agents (ESA).~        2. To compare this electronic process with present anaemia management in the traditional~          outpatient setting.~        3. To monitor Hb targets and clinical endpoints of study groups to model a larger~          multicentre study focusing on these endpoints.~   "
98848|NCT01763229|"~     To test if transthoracic echocardiography is useful for correct positioning of central~     venous catheters in infants with congenital heart disease~   "
98849|NCT01763216|"~     Late-life depression levels are escalating, and include 24% of all tenants of Assisted~     Living (AL) settings. A promising, novel intervention is a computerized visual speed of~     processing training program known as Road Tour. Road Tour has been show to reduce depressive~     symptom levels and the risk of onset of clinical depression in community dwelling older~     adults. The investigators hypothesize that similar benefits will accrue to residents in AL~     settings.~      To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial~     (RCT) comparing Road Tour training to attention control using computerized crossword puzzles~     among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering~     with the investigators.~      The investigators hypothesize that Road Tour participants will have improved cognitive~     processing speed, lower levels of depressive symptoms, lower likelihood of the onset of~     clinical depression, less anxiety, lower levels of pain symptoms, and better health-related~     quality of life. These outcomes will be assessed at baseline, post-training, six months, and~     one year.~   "
98850|NCT01763203|"~     The purpose of this study is to test a newly-developed outpatient clinic and community-based~     care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and~     Chronic care model teams Early to End Disparities) for improving control of stroke risk~     factors among stroke patients in the Los Angeles County safety net, and to measure the~     costs of running such an intervention, relative to usual care.~   "
98851|NCT01763190|"~     Primary Objective:~      To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of~     SAR302503.~      Secondary Objective:~      To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild,~     moderate and severe renal impairment and in matched subjects with normal renal function.~   "
98852|NCT01763177|"~     Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat~     (POST). Oxygen nebulizer therapy increases humidity to the airway, especially~     post-extubation.~      Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.~   "
98925|NCT01762228|"~     This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive~     physiology) the effect on the deglutition of two therapeutic treatments with the duration of~     2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal~     dysphagia:~        1. Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels~          using a natural agonist administrated in the alimentary bolus.~        2. Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous~          electrical stimuli.~      Moreover, with an electroencephalographic study we will assess the effect of both treatments~     in the cortical neuroplasticity.~   "
98853|NCT01763164|"~     Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the~     efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks)~     in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61~     mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be~     performed at a central laboratory. Only those patients with Q61 mutation per central~     laboratory and meet all eligibility criteria will be randomized. A total of 393 patients~     will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified~     according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0~     versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This~     study will use an Interactive Response Technology (IRT). The primary end point of the study~     is progression-free survival. Key secondary end point is overall survival~   "
98854|NCT01763151|"~     With increasing demands of patients concerning refractive outcome after cataract surgery,~     toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more~     widely to cataract surgery. Originally toric IOLs were used mainly for patients with high~     degrees of astigmatism, especially after corneal surgical procedures such as penetrating~     keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers~     to correct lower amounts of astigmatism which are much more prevalent with about 30% having~     a corneal astigmatism of 0.75D or more in the cataract population. This should result in~     less spectacle dependence of patients due to the astigmatic correction.~      The alternative method to reduce corneal astigmatism as part of cataract surgery is to make~     incisions on the steeper axis of the cornea such as limbal relaxing incisions or an~     additional clear corneal incision opposite (OCCI) to the main cataract opening. These~     techniques are in use since more than 2 decades and are widely used in clinical routine. As~     with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential.~     The disadvantage of the incisional techniques is the variability of the effect between~     patients since it depends on factors such as the extent of scaring of the cuts after surgery~     as well as corneal thickness. The main advantage is the simplicity of the technique and the~     lower cost.~      Aim of this study is to compare toric IOL implantation and opposite clear corneal incision~     during cataract surgery to correct corneal astigmatism.~   "
98855|NCT01763138|"~     The purpose of this study is to determine the effect of an educational intervention on~     mothers knowledge, attitudes and practices for preventing childhood caries.~   "
98856|NCT01763125|"~     Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy~     people as controls. The blood samples will be collected systematically together with the~     corresponding clinical data. The biological samples, the clinical date together with~     prospective experimental date constitute the entity of the tumor bank.~   "
98857|NCT01763112|"~     Title of study / project: Influence of training with whole body vibration device on Quality~     of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle~     function in patients with pulmonal arterial hypertension (PAH). Background and rationale for~     the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is~     a few investigations evaluating the effects of the training with whole body vibration (wbv)~     in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and~     had positive effects on the neuromuscular system. Primary scientific question~     addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in~     QoL are to be evaluated.~   "
98858|NCT01763099|"~     The purpose of this study is to evaluate the utility of treating patients experiencing graft~     failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded~     BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined~     with cord blood. The first objective of this study was to evaluate the effect of such~     treatment on graft failure, and second object was to investigate the safety of such~     treatment.~   "
98859|NCT01763086|"~     The purpose of this study is to evaluate the utility of treating patients experiencing poor~     graft function after allogeneic hematopoietic stem cell transplantation with~     ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first~     objective was to evaluate the effect of such treatment on poor graft function, and second~     object was to investigate the safety of such treatment.~   "
98860|NCT01763073|"~     The objective of this study is to ascertain factors shaping medical students' pre-residency~     intention to provide abortion through an in-depth qualitative investigation into the context~     and experiences that shape intention to provide.~   "
98861|NCT01763060|"~     Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or~     circulatory failure show severe long term disability due to impaired lung -, cerebral-,~     cognitive function and impaired quality of life. This study investigates the long term~     outcome of all patients who are still alive three years after ECMO treatment for severe~     respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.~   "
98862|NCT01763047|"~     The objective of this study is to evaluate the performance of a novel multifocal lens~     system.~   "
98863|NCT01763034|"~     Contrast media induced nephropathy (CIN) is considered to be a serious complication in~     patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well~     understood. The probable one is the contrast media makes the afferent vessel in glomeruli~     constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that~     makes muscles become ischemic and adapt themselves to produce some cytokines for signaling~     the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic~     circulation and effect the afferent vessel in glomeruli to become more dilated and prevent~     CIN.~   "
98864|NCT01763021|"~     The purpose of this study is to assess the potential effects of rifampin on the~     pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy~     participants.~   "
98865|NCT01763008|"~     The purpose of this study is to assess the safety and effectiveness of doripenem treatment~     among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections,~     and complicated urinary tract infection.~   "
98926|NCT01762215|"~     This study examines the use of an online social media platform (PatientsLikeMe) to assist~     Veterans with epilepsy. The hypothesis is that the online social media platform,~     PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management~     skills for patients who engage in the website functions.~   "
98866|NCT01762995|"~     Human immune virus (HIV) infected subjects may take mineral supplements in combination with~     their antiretroviral medications. Calcium and Iron supplementations are commonly used and~     both of these have the potential to interact with Dolutegravir (DTG), this study will~     evaluate the potential of calcium and iron supplements to decrease DTG exposure. It will~     also evaluate two possible strategies for combined use; if an interaction is observed. The~     first strategy is a two hour separation. The second strategy involves the administration of~     DTG and the supplement with a meal since the presence of food modestly increases DTG~     exposure, and because mineral supplements can be administered with food.~      This is an open label, randomized, two cohort, four-period cross-over study in healthy~     volunteers. One cohort will examine the effects of calcium carbonate and the other cohort~     will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG.~     Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of~     four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg)~     administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a~     single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single~     dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous~     fumarate with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted~     conditions 2 hours prior to administration of a single dose of calcium carbonate or ferrous~     fumarate. There will be a washout period of at least 7 days between treatments. Safety~     evaluations and serial PK samples will be collected during each treatment period. A~     follow-up visit will occur 7-14 days after the last dose of study drug. This study will be~     conducted at one center in the United States, with healthy adult male and female subjects.~   "
98867|NCT01762982|"~     The aim of the study is to evaluate the irritation potential of benzalkonium chloride~     disinfectant spray when placed in contact with normal human skin.~   "
98868|NCT01762969|"~     The investigators will check the feasibility of using early molecular response for making~     treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib~     treatment. After 3 months of treatment their response will be assessed. If molecular~     response would be less the 10% (BCR-ABL1/ABL ISI >10%)imatinib therapy will be stopped and~     patients will start a different TKI (as nilotinib, dasatinib). The investigators will follow~     on lab and clinical outcomes.~   "
98869|NCT01762956|"~     The pelvic floor disorders are a major problem in our current society with manifestations of~     micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles~     training arouses interest due the few studies on this subject. Studies are being conducted~     with emphasis on the post-prostatectomy urinary disorders, however, not associated with~     radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain.~     At right, we do not know if the effect of radiation can trigger important anatomical changes~     that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary~     disorders. These issues motivate us to research, focusing on the evaluation of these muscles~     through magnetic nuclear resonance considering that radiation therapy has been increasingly~     used as a therapeutic option in the treatment of prostate cancer. The primary objective of~     this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS),~     anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy~     (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the~     severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of~     the changes occurred by the effect of radiation separately and jointly to the training of~     the pelvic floor muscles can help us to better understand some of the dysfunctions presented~     in this sample of patients as well as understanding the effect and the possible contribution~     of training of these muscles for treatment and/or prevention of these disorders.~   "
98870|NCT01762943|"~     Understanding the neural and biological mechanisms by which reproductive hormones influence~     mood is critically important for public health given that postpartum depression is the~     leading cause of morbidity and mortality associated with childbirth and has negative effects~     on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve~     our ability to identify the biological mechanisms underlying both the triggering of and~     susceptibility to depressive disorders in women; and will permit the prediction of those at~     risk for PPD and other reproductive-related mood disorders.~   "
98871|NCT01762930|"~     Background:~      Cholera is a public health problem globally and in Bangladesh and its prevention is~     important. Despite recent availability of an effective and affordable oral cholera vaccine~     (OCV), its field application remains a challenge and needs to be addressed in carefully~     conducted research studies.There is lack of information on temperature sensitivity and~     resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses~     of OCVs, one month apart, instead of currently recommended 14 days, to improve success of~     vaccination programme will be effective;also if one dose of the vaccine, instead of~     currently recommended two doses, would result in adequate immune response in population~     exposed to V. cholerae in an endemic country like Bangladesh.~      Objectives:~      To determine immunogenicity of Shanchol in adults. when:~        1. the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days,~          before putting back in cold box for administration in the field and compare them with~          the response when the vaccine is stored under currently recommended temperatures.~        2. two doses of the vaccine administered one month apart and compared vaccines~          administered at currently recommended interval of 14 days.~        3. a single dose is administered and compare them with responses after recommended two~          doses.~      Methods: The study will be conducted among adults living in the Mirpur community in urban~     Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses~     over a period of one year.~      Outcome measures/variables:~        1. Objective 1: safety and immunogenicity of vaccine in adults after its storage at three~          defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses~          and compare them with the findings when the vaccine is stored at currently recommended~          temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).~        2. Objective 2: compare vibriocidal responses following administration of two doses of the~          vaccine one month apart and compare them with vaccination 14 days apart over a period~          of one year, with study of the memory responses over a one year period as a secondary~          outcome.~        3. Objective 3: compare acute immune responses (vibriocidal antibody) following one and~          two doses of vaccine, and compare memory response as a secondary outcome measure, over~          a one year period.~      The above information is needed urgently for developing effective vaccination strategies for~     prevention and control of cholera in endemic countries.~   "
98872|NCT01762917|"~     Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising~     results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing~     bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high~     grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore~     fail to completely mix the test gases. The aim of our study is to evaluate the effect of~     adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group~     A), restriction (group B) and pulmonary healthy controls (group C).~   "
98873|NCT01762904|"~     Currently there are few options for skin antisepsis, commercially antiseptic triclosan is~     mainly used. To have more options, this study is necessary, where investigators will~     determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan~     in 70% isopropyl alcohol and choose the one with the best characteristics for skin~     antisepsis.~   "
98874|NCT01762891|"~     Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin~     are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of~     bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating~     pain and inflamation in these patients once interactions with coumadin are supposed to be~     lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI~     with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen~     and placebo.~   "
106790|NCT01659125|"~     The primary aim of this study is to learn about who is most likely to benefit from guided~     self-help (GSH) for obsessive-compulsive disorder (OCD).~   "
98875|NCT01762878|"~     GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta~     (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of~     inflammatory airway diseases. GSK2269557 has already been administered as a nebulized~     solution in single and repeat doses to humans and has been well tolerated across the range~     of doses used. The purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This~     study is the first administration of dry powder GSK2269557 in humans.~      Part A will consist of four treatment periods separated by at least 14 days wash out~     periods. In each treatment period there will be 12 subjects receiving GSK2269557 and 4~     subjects receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms~     (mcg), 500 mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be~     reviewed before each dose escalation. Part B will be a parallel group design conducted in a~     separate group of subjects from Part A. Nine subjects will receive repeat doses of~     GSK2269557 and 3 subjects will receive repeat doses of placebo for 14 days. The total daily~     dose will be the same as the dose that was well tolerated in Part A. The study duration,~     including screening and follow-up, is not expected to exceed 82 days for subjects in part A~     and 55 days for subjects in part B of the study.~   "
98876|NCT01762865|"~     The investigators hypothesized that acute bronchitis will be associated with various~     bacteria and viruses.~   "
98877|NCT01762852|"~     The main clinical study will be a randomized, double-blind, placebo-controlled, long term~     study involving a 100 week treatment period. The purpose of this study is to test for~     superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo~     plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this~     study is also to investigate the effect of initiating earlier treatment with belimumab~     compared to delayed treatment with current immunosuppressive treatment regimens. The study~     will also determine the pharmacokinetic (PK) profile of belimumab and further explore the~     mechanism of action of Belimumab as well as effects on quality of life. All subjects (on~     either active treatment or placebo) will receive background supportive therapy throughout~     the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi)~     and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins,~     diuretics, dietary salt restriction but excludes immunosuppressants (except low dose~     corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose~     of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such~     that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo.~     Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including,~     Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing~     frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by~     urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h),~     to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study~     treatment at any time during the study, eg for rescue therapy, will participate in follow-up~     visits every 12 weeks up to week 104. A subject will be regarded as having completed the~     main clinical study if they complete all phases of the main clinical study (screening,~     treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects~     who complete the main clinical study will therefore participate in the main clinical study~     for approximately 28 months. After the main clinical study, there will be a 5 year (long~     term) follow-up phase to assess long term outcomes.~   "
98878|NCT01762839|"~     The purpose of the study is to generate cardiac safety data using a supratherapeutic~     oritavancin dose of 1600 mg.~   "
98879|NCT01762826|"~     Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in~     non-obese pregnant women at high risk for gestational diabetes mellitus.~   "
98880|NCT01762813|"~     -  A prospective, observational study on clinical outcomes of surgical management of~          primary and metastatic colorectal cancer~        -  Prospective collection of tissues to explore potential biomarkers in blood and/or~          primary or secondary cancers and/or normal colon~   "
98881|NCT01762800|"~     The purpose of this study is to assess the control of COPD using a symptom and exacerbation~     risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese~     subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical~     practice in Japan.~   "
98882|NCT01762787|"~     The purpose of this study is to refine the cantharidin-induced blister assay in healthy~     volunteers as a model of inflammatory disease. The study is an experimental trial in healthy~     volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two~     anti-inflammatory treatments with different modes of action.~   "
98883|NCT01762774|"~     This study is the First Time in Human Study for GSK2256294 and will evaluate the safety,~     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral~     doses of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy~     adult male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects~     each and each subject will take part in four study periods. All subjects will receive~     placebo regimen and three dosing regimens of GSK2256294 in a specified sequence (planned~     doses 2 mg, 6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study~     period will be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks~     in Cohort 2. During each study period subjects will be in-house from Day -1 until the 48~     hours post dose assessments have been completed. Subjects will return to the unit as~     out-patients for remaining post-dose assessments. Subjects will then be followed for 7 to 14~     days in Cohort 1 and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort~     1 will be 98 days and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each~     recruit 15 subjects. For Cohorts 3 and 4, each subject will take part in one treatment~     period of 18 days (Day-1 to Day 17) with dosing from Day 1 to Day 14. Subjects will then be~     followed for 7 to 14 days. Total duration of the study for Cohort 3 and Cohort 4 will be 67~     days. Dose selection for Cohorts 3 and 4 will be based on the safety, PK profile and enzyme~     inhibition obtained in Cohorts 1 and 2. This study will also evaluate the evidence for a~     functional effect of soluble Epoxide Hydrolase (sEH) in a forearm blood flow (FBF) model.~   "
98919|NCT01762306|"~     Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number~     of patients, the diagnosis of its cause is performed via fractional curettage under local~     anesthesia such as paracervical nerve block or intravenous meperidine.~      Pain is one of a common adverse effect of this procedure and this topic should be concerned~     by a responsible doctor.~      NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain~     control and is as effective as coxib in acute pain management. Because of its cost, easy~     accessible and easy administration, Diclofenac Potassium was selected to be used in this~     study. Its onset of action is about 1 hour and only one dose of this drug do not cause any~     serious side effects.~      The hypothesis of this study is that Diclofenac Potassium has an additional effectiveness~     for acute pain control in patients undergoing fractional curettage under paracervical nerve~     block due to abnormal uterine bleeding Double blind randomised controlled trial was~     performed in this study with 45 patients included in each group.~   "
98884|NCT01762761|"~     This randomized, double-blind and open-label phase III study is aimed to determine the~     efficacy, tolerance and safety of eltrombopag in Chinese chronic primary immune~     thrombocytopenia (ITP) adult subjects. This study will be conducted in Chinese adult chronic~     ITP subjects who have not responded to or have relapsed after previous treatment for ITP,~     including first line therapy and /or splenectomy.~      The primary objective of this study is to determine the efficacy of oral eltrombopag as a~     thrombopoietic agent treating previously treated chronic Chinese ITP patients comparing with~     placebo. The secondary objective is to assess the safety and tolerability of eltrombopag~     when administered for 6 weeks to previously treated adult chronic ITP patients comparing~     with the placebo. In addition, the long-term efficacy and safety of eltrombopag treatment~     will be also evaluated in the 24-week extension open-label phase after the double-blind~     phase as one of other study objectives. If the subject benefits from the eltrombopag~     treatment based on investigator's discretion, the subject can continue eltrombopag treatment~     until the commercial launch of eltrombopag in China. Furthermore, to understand the~     pharmacokinetics (PK) profile of eltrombopag and to explore the relationship between the PK~     and pharmacodynamics (PD) (platelet response), a PK/PD analysis will be embedded in this~     phase III study and conducted in the same patient population participated this phase III~     study.~   "
98885|NCT01762748|"~     The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients~     in the waiting list for liver transplant.~   "
98886|NCT01762735|"~     Water injection colonoscopy has been a generally accepted method in training the beginners~     of colonoscopy for its low pain and less cecal intubation time, we would conduct this study~     to investigate more advantages of this method and make most use of it for beginners'~     training.~   "
98887|NCT01762722|"~     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the~     brain. It is similar to the device that measures the level of oxygen in the tip of the~     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the~     forehead that both emits and detects the amount of light absorbed. This study will determine~     how accurate the device is by comparing the displayed value on the monitor with blood~     samples taken simultaneously from the arterial blood in the wrist and venous blood in the~     neck. In order to test the device over a suitable range, the level of oxygen within the~     blood will be reduced in a controlled manner by reduction of the inspired oxygen~     concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study~     will be conducted in healthy volunteers.~   "
98888|NCT01762709|"~     The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery~     decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use~     of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the~     extravascular lung water content index (EVLWI). After local ethics committee approval and~     informed consent, we will randomly allocate 60 patients scheduled for elective VATS to~     ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1:~     2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to~     maintain normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will~     be recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and~     mortality will be recorded~   "
98889|NCT01762696|"~     The purpose of this study is to further develop and test the Momentary Self-Monitoring and~     Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual~     intervention to reduce marijuana use among primary care patients.~   "
98890|NCT01762683|"~     The purpose of this study is to improve the understanding of cellular mecanism involved in~     delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of~     myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of~     blood mononuclear cells, of leptine and of obese women sera to interfere with the transition~     of myometrial cells toward hyperplasia phenotype.~   "
98891|NCT01762670|"~     GoldenCare is a copper intravaginal device that may be useful for the treatment of~     symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although~     the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The~     study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to~     collect preliminary evidence of the safety and efficacy of GoldenCare.~   "
98892|NCT01762657|"~     The purpose of this study is to determine if oral Cyclosporine A and oral Lansoprazole are~     effective in rendering patients with existing type 1 diabetes, insulin independent. This~     two-arm study was designed to evaluate the safety and efficacy for insulin independence by~     utilizing the FDA-approved oral immune tolerance agent, Cyclosporine A, and the FDA-approved~     proton-pump inhibitor, Lansoprazole. Lansoprazole and other proton-pump inhibitors increase~     gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell~     formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).~      Studies with the immune tolerance agent, Cyclosporine A, previously demonstrated that among~     recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as~     67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.~     1988:17;318(11):663-70). Cyclosporine A protected the remaining beta cells from further~     autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was~     ultimately required by all patients. Therefore, this study proposes the usage of~     Cyclosporine A with a beta regeneration agent.~      Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for~     20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab~     Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor~     demonstrated reductions in daily insulin requirements by much as 75% within 3 months~     following four weeks of therapy among existing type 1 diabetes patients (Transition~     Therapeutics, March 5, 2007 http://www.transitiontherapeutics.com/media/archive.php Accessed~     January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing~     autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown~     to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth~     factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).~      Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune~     tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been~     successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.~     2007;1103:19-32). The distinctions and complexities of islets in man are far different than~     that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 Epub ahead of~     print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration~     agent are required to sustain insulin independence.~      Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to~     10-fold, this clinical trial utilizes the oral proton-pump inhibitor, Lansoprazole. This~     study will determine the safety and efficacy of Cyclosporine A used with and without~     Lansoprazole to determine the impact on insulin independence among patients with existing~     type 1 diabetes.~      Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole. The~     combination of the two therapies may render reductions in insulin requirements and have a~     greater impact on sustained insulin independence than previously reported with Cyclosporine~     A or gastrin alone among type 1 patients.A~      This 52-week study consists of two treatment arms designed to assess the safety and efficacy~     of achieving insulin independence using:~        -  Oral Lansoprazole/Oral Cyclosporine A~        -  Oral Placebo/Oral Placebo~      It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will~     safely render significantly more patients with existing type 1 diabetes, insulin independent~     and may serve as a novel and innovative treatment approach for patients with type 1 diabetes~     utilizing two FDA-approved therapies.~   "
98893|NCT01762644|"~     The purpose of this study is to determine if the combination of oral cyclosporine, an immune~     therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin~     independence among recent onset type 1 diabetes patients. This two-arm study is designed to~     evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved~     therapies among recent onset type 1 diabetes patients.~      One of the greatest new insights of today in the field of type 1 diabetes, is the~     understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is~     no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now~     considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan~     2103).~      More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some~     studies have demonstrated as high as a 57% insulin-free remission rate that was not~     sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988,~     Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors~     have shown the potential to increase beta cell mass by 40%, but among type 1 patients~     without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014).~      The usage of a beta cell regeneration agent such as omeprazole, in combination with an~     immune tolerance, like cyclosporine, provides both the potential ability to maintain and~     regenerate beta cells. This is a new paradigm for the treatment of new onset type 1~     diabetes.~      More than 60 human trials have been conducted among type 1 diabetes with a variety of~     different therapies aimed at preventing autoimmune attack on insulin-producing beta cells.~     None have been as effective as cyclosporine in both slowing the decline in beta cell mass~     and resulting in the potential for insulin-free remissions. (Canadian-European Randomized~     Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010).~      Because cyclosporine is known for its potential side-effects, most notably in the kidney,~     all previous studies among type 1 patients have carefully monitored kidney function.~     Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20~     months did not demonstrate renal or other side effects at the dosages that will be used in~     this trial (Assan 2002).~      The most effective initiating dosage for insulin independence in the cyclosporine trials was~     7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and~     will monitor kidney function and cyclosporine levels initially on a weekly basis. This study~     will use only those dosages of cyclosporine that have not demonstrated toxicity to the~     kidney or resulted in non-reversible side effects among more than 500 patients with recent~     onset type 1 diabetes treated with cyclosporine.~      Omeprazole has been shown to significantly increase gastrin levels which is associated with~     increased beta cells. Lansoprazole has also been shown to be safe among patients with new~     onset type 1 diabetes for one year with a trend toward increased beta cell mass among~     patients with higher gastrin levels.~      In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those~     randomized to receive a proton pump inhibitor had significantly increased gastrin levels,~     higher insulin levels and improved endocrine function by glucose tolerance testing and less~     pancreatic atrophy as measured by CT scans (Jang 2003).~      The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton~     pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its~     endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta~     cells was specifically noted to have likely been due to lack of usage of immune therapy to~     protect beta cells (Griffin 2014, Rigby 2014).~      Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the~     control group had a trend towards improved preservation of C-peptide with a suggestion of a~     decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental~     data). Glucose levels also trended lower than controls in the intervention arm with gastrin~     levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly~     forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006).~     REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy~     among type 1 patients (Griffin 2014, Rigby 2014).~      The combination of cyclosporine with a proton pump inhibitor has the potential to~     demonstrate maintenance and expansion of residual beta cells. This combination therapy~     provides the unique ability for patients to become insulin independent.~      For a request of references, please email info@perlebioscience.com~   "
98894|NCT01762631|"~     The purpose of this study is to determine if digital photography on a Smartphone and the~     Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a~     validation study; there is no hypothesis.~   "
98895|NCT01762618|"~     A randomized controlled trial designed to test the effectiveness of a psychological~     intervention based on group therapy for the caregivers of Alzheimer's disease patients. The~     intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy.~     This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group~     counseling, with an improvement in mood state, quality of life, perceived burden and a~     decrease in anxiety and depression. Two evaluations will be done: before the therapy~     sessions (basal) and when intervention is finished (final).~   "
98896|NCT01762605|"~     This study determines if patients with buckle fractures of the distal radius and/or ulna~     treated with supportive care only demonstrate non-inferior outcomes in regard to pain~     control during healing, functional outcome at the wrist joint, and parental satisfaction,~     when compared with patients treated with the standard treatment regimen of 3-4 weeks in a~     short arm cast.~   "
98897|NCT01762592|"~     Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine~     (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate~     cT1-renal masses.~   "
98920|NCT01762293|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study~     has shown that the toxicity is manageable.~      The purpose of this study is to determine whether Famitinib can improve progression free~     survival compared with placebo in patients with advanced colorectal cancer who failed in~     previous at least two lines of chemotherapy.~   "
98921|NCT01762280|"~     Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and~     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of~     Famitinib in patients with solid tumor~   "
98898|NCT01762579|"~     The aim of the investigators' study is to evaluate biochemical, immunological and~     histological characteristics of patients affected with the so-called gluten (or wheat)~     sensitivity who suffers from irritable bowel syndrome (IBS)-like symptoms.~      As it is not known what component of the cereals causes the symptoms in so called~     gluten-sensitive patients, the investigators prefer to speak of not-celiac wheat~     sensitivity (NCWS).~      NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop~     symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our~     research, we will select adult patients, both genders, affected with suspected NCWS (i.e.~     with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing~     negative for celiac disease [anti-tissue transglutaminase antibodies, anti-tTG, and~     anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1] and wheat allergy [serum~     specific IgE for wheat]). The patients will be recruited at the Department of Internal~     Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of~     the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms.~      At the time of the recruitment, the patients will be on GFD by at least one month and must~     be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg~     and other foods) could be prescribed in patients who are suspected to suffer from multiple~     food hypersensitivity. The patients will be randomized to undergo a double-blind~     placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days.~     Before and after the challenge, the investigators will evaluate gastrointestinal~     (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood~     sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and~     rectoscopy, with multiple biopsies), for the identification of possible markers~     (serological, biochemical, immunological, histological features, expression of cytokines and~     other constitutive mucosal proteins from peripheral blood mononuclear cells and mucosal~     lymphocytes) that may be of help to diagnose the condition of NCWS and to understand its~     pathogenesis.~   "
98899|NCT01762566|"~     Aim of the investigators' study is to evaluate one of the symptoms described by patients~     affected with the so-called not-celiac wheat sensitivity (NCWS). NCWS patients may be~     defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat~     consumption and improve on Gluten Free Diet (GFD). Among these, patients often report the~     appearance of bloating and abdominal pain, and, sometimes, swelling of fingers and face,~     shortly after ingestion of wheat. They also refer that swelling tends to last for some hours~     and then to disappear on GFD. To our knowledge, this disorder has never been investigated~     neither proved.~      For the investigators' research, the investigators selected adult patients, both genders,~     affected with NCWS. Diagnostic criteria include: 1) symptoms disappearance on GFD, 2)~     testing negative for celiac disease [anti-tTG and EMA, and with biopsy Marsh 0-1] and wheat~     allergy [serum specific IgE for wheat], 3) positive response to a double-blind~     placebo-controlled challenge (DBPC) with wheat or placebo.~      Patients will be recruited among subjects referring, as outpatients, to the Department of~     Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal~     Medicine of the University of Palermo, from January 2012 to October 2013. The investigators~     will include patients referring for functional dyspepsia and/or irritable bowel syndrome~     (IBS)-like symptoms. All recruited patients must report body's swelling immediately after~     wheat ingestion. In all recruited patients, NCWS diagnosis was posed during the previous~     years, according to the above mentioned criteria.~      Patients, all on GFD for at least 30 days, will undergo to another DBPC with wheat or~     placebo (xylose), performed by administering capsules coded as A or B containing wheat or~     xylose, respectively. Capsules A or B will be administered once, and then, after 1 week of~     washout, patients received the other capsules, given once too. Before and 2 hours after~     every challenge, patients will undergo a complete medical examination (measurement of body~     weight, height, body mass index [BMI], waist circumference, diameter of thighs, legs, arms,~     and fingers), and we will perform bioelectrical impedance analysis and collect blood~     sampling, for identification of possible markers (bioelectrical, immunologic, hormonal, etc)~     that may help to demonstrate and explain mechanisms of examined symptom.~   "
98900|NCT01762553|"~     The impact of HIV/AIDS is negatively influencing the affected families and their next~     generation. HIV is radiating through the extended families, shifting the life patterns not~     only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and~     other family members. To help PLHs and their family members, the TEA intervention has been~     developed, refined and piloted in the previous study. The goal of this study is to implement~     the TEA intervention in a full scale to determine its efficacy and the potential for~     enhancing HIV policy and programs that support HIV-affected families to cope with the~     challenges in China in responding to the global HIV epidemic.~   "
98901|NCT01762540|"~     The main purpose of the trial is to advance our knowledge on the possible mechanism~     underlying the catabolic effects of long-term treatment with glucocorticoid.~   "
98902|NCT01762527|"~     This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a~     library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure~     includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse~     effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as~     well as cineMR for intra-fractional motion (baseline and every week during RT). Patients~     receive standard non-adaptive RT in the first week. Delineations of the bladder on the~     Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and~     Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used~     for the first week of treatment. A margin of 5 mm for intra fractional movement is used.~   "
98903|NCT01762514|"~     RATIONALE~        -  Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.~        -  Radiotherapy may cause adverse effect such as xerostomia and mucositis.~        -  Amifostine has the ability of protecting the normal tissue but also has some side~          effects.~      PURPOSE~        -  This phase II trial is to study the protecting effect and safety of different~          Amifostine regimens in patients with nasopharyngeal carcinoma.~   "
98904|NCT01762501|"~     To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration~     once per day for 8 weeks in patients with grade I or grade II essential hypertension.~   "
98905|NCT01762488|"~     The purpose of this double-blind, randomized and sham controlled study is to investigate the~     blood pressure lowering effect of renal denervation by catheter based ablation in the renal~     arteries in patients with milder forms of treatment resistant hypertension. The effect on~     blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at~     baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises~     hemodynamic assessment by applanation tonometry and the cold pressor response.~   "
98906|NCT01762475|"~     The purpose of this study is to determine whether sildenafil (Viagra®) is effective in~     improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent~     symptoms at least 6 months after a traumatic brain injury (TBI).~   "
98907|NCT01762462|"~     Primary Objective:~      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of~     SAR302503.~      Secondary Objective:~      To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with~     mild and moderate and hepatic impairment and in matched subjects with normal hepatic~     function.~   "
98922|NCT01762267|"~     To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the~     metabolic side effects of corticosteroids medications use.~   "
107044|NCT01655771|"~     The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated~     by the body and to evaluate whether it is safe and well tolerated.~   "
98910|NCT01762423|"~     Body contouring surgery has a higher potential for postoperative pain and wound healing~     complications. The purpose of this study is to determine if pulsed electromagnetic field~     (PEMF) devices can reduce the pain and complications associated with this type of surgery.~      Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to~     decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in~     whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have~     been FDA approved for treatment of pain and edema (510(k) number: K070541). More recently,~     PEMF devices have been shown to decrease postoperative pain and narcotic use in breast~     augmentation patients. This study seeks to determine if PEMF will also cause similar effects~     in the more complex procedures performed on body contouring patients. The specific aims of~     this study are:~        1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain~          reduction in abdominal body contouring patients.~        2. Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain~          relievers in abdominal body contouring patients.~      PEMF devices have been shown to be effective in reduction of pain and pain medication use in~     breast augmentation patients. No literature has shown if PEMF is an effective adjunct to~     decrease pain or pain medication use in the abdominal body contouring patient. A decrease in~     pain would result in a better experience for patients and a reduction in pain medication may~     decrease complications associated with these medications. The PEMF therapy device being used~     in this study is a non-significant risk device because it is noninvasive and does not~     present a potential for serious risk to the health, safety, or welfare of a subject.~   "
98911|NCT01762410|"~     Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid~     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting~     toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors~   "
98912|NCT01762397|"~     The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation~     clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and~     food effect of PMK-S005 after oral administration in healthy male volunteers.~   "
98913|NCT01762384|"~     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms~     such as loss of control of the bowel or bladder, and may also cause problems with patient's~     sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure.~     Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery~     with mesh is developed in China for Asian Women.~      This study is designed to determine the effectiveness and safety of Modified total pelvic~     floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the~     treatment of uterine or vault prolapse Stage III-IV.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
98914|NCT01762371|"~     The primary hypothesis is that Khalifa's therapy has different acute effects in various~     organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These~     effects might indicate the pathway of the therapy.~   "
98915|NCT01762358|"~     The primary hypothesis is that Khalifa's therapy brings additional benefit compared to~     standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament~     (ACL).~   "
98916|NCT01762345|"~     This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device)~     by reduction in urine leakage in women with stress urinary incontinence (SUI).~   "
98917|NCT01762332|"~     In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain~     response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has~     been changed to NoL (Nociception Level) Index.~      The PRI is based on a non-linear combination of several pain-related physiological~     parameters into a one unique index (0-100).~      In this study we aim to validate the performance of the PRI by:~        1. investigating the patient's PRI response to surgical painful stimuli under different~          levels of analgesia:~             -  Investigating patient's PRI response to surgical painful stimuli under two~               different levels of Remifentanil Target Control Infusion (TCI) rates.~             -  Investigating patient's PRI response to standardized painful stimulus (Tetanic~               stimulus) with and without opioids.~        2. investigating the effect of beta-blockers on PRI performance in patients taking chronic~          beta-blocker treatment.~      The study is based on recording and analyzing the subject's physiological signals, while~     recording painful events, medication dosing and different clinical signs.~   "
98918|NCT01762319|"~     Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic~     procedure of this condition. Traditionally, fractional curettage is performed under local~     anesthesia such as paracervical nerve block or intravenous meperidine.~      Cervical dilatation using metal cervical dilator is a common method prior to perform~     fractional curettage. However, complication from this procedure can be occurred frequently,~     for example, uterine perforation, false tract formation and laceration of cervix.~      Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and~     gynecology. Misoprostol transforms cervical component causing cervical ripening. This is~     very helpful for transcervical procedure because cervical dilatation is usually omitted. It~     can be prescribed in many route and sublingual route is the most effectiveness. Moreover,~     WHO supports the use of misoprostol in obstetrics and gynecology practice.~      The hypothesis of this study is that Misoprostol 200 micrograms sublingually is effective~     for cervical ripening before performing fractional curettage in patients with abnormal~     uterine bleeding Double blind randomised controlled trial was performed using 26 patients~     in each group.~   "
98923|NCT01762254|"~     To compare the two surgical options in their short-term and long term outcomes in the~     management of early left-sided colorectal cancers. The hypothesis is that the incisionless~     approach will result in less postoperative pain and wound related complications.~   "
98924|NCT01762241|"~     The purpose of this study is to investigate the effect of 12 weeks systematically training~     using the Xbox Kinect system.~      Outcome measures are made on physical function, quality of life, fatigue and metabolic~     parameters.~   "
110009|NCT01616316|"~     Subfascial approach method in thyroidectomy maybe result in better quality of life than~     conventional approach method in thyroid disease patients~   "
98930|NCT01762163|"~     This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind~     adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and~     placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis~     syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks~     of treatment there will be an interim analysis.~   "
98931|NCT01762150|"~     The goal of this clinical research study is to learn the effectiveness of sorafenib combined~     with gemcitabine plus cisplatin in the treatment of patients with locally advanced or~     metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will~     also be studied.~   "
98932|NCT01762137|"~     In this study, patients with large anterior circulation IAs with neck and fundus~     morphologies amenable to either traditional endovascular treatments using coils or~     reconstruction with the flow diversion will be randomly assigned to either treatment~     technique.~   "
98933|NCT01762124|"~     The purpose of this early feasibility study is to determine how a new transcatheter~     pulmonary valve will move and perform once implanted in the right ventricular outflow tract.~   "
98934|NCT01762111|"~     The woman fertility decrease with the age and there is a closely link with the ovarian~     reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate~     the ovarian reserve with specific marker to have a better prediction of the response of the~     in vitro fertilization treatment and to have a better rate of pregnancy.~      Until now, a lot of clinical criteria (age, duration of the infertility, number of antral~     follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at~     the retrieval day) was suggested to help for the estimation of the ovarian reserve.~      Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best~     ovarian reserve marker, it corresponding the number of antral follicles, it is more~     sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian~     hormone can provide the weak responds at the stimulation and the reverse, the risk of~     excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate~     (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the~     anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to~     evaluate the quantity of available eggs in the ovaries, his role to determine the quality of~     these eggs still discussed.~      The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good~     indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian~     hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro~     Fertilization protocol.~   "
98935|NCT01762098|"~     Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis~     is asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have~     genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal~     white loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.~      Some studies showed that the endometritis could have an impact on the embryo implantation~     and could explain recurrent miscarriages or repeated embryo implantation failures.~      The goal of this study is to evaluate the frequency of the chronic endometritis in patients~     with recurrent miscarriages or repeated embryo implantation failures~   "
98936|NCT01762085|"~     Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic~     foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve~     pinching and entrapment. Historical risk of 25% annually has been reported to decrease by~     >80% to under 5% yearly. Since an open wound precedes the large majority (85%) of~     amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the~     current academic opinion that nerve decompression will not decrease ulcer recurrence risk.~     Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.~   "
98937|NCT01762072|"~     Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy)~     concentration. However, the combined effect of these nutrients on Hcy and ferritin, and~     C-reactive protein is limited and inconclusive. The objective was to examine the synergistic~     effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other~     biochemical markers. In a randomized controlled trial, thirty eligible subjects were~     randomly divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish~     oil, or 1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid~     (PL) fatty acids and biochemical markers were determined. we hypothesize that combination of~     vitamin B12 and fish oil have synergistic effect on lowering plasma concentrations of Hcy~     and ferritin.~   "
98938|NCT01762059|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improved glycemic control vs. usual in~     the outpatient environment.~   "
98939|NCT01762046|"~     The SUGAR-MGH investigators are studying the influence of inherited gene variants on the~     response to two commonly prescribed type 2 diabetes medications, metformin and glipizide.~     They hypothesize that variants in genes that are associated with type 2 diabetes or related~     traits may impact the effect of anti-diabetic medications. In addition, physiological~     responses to an insulin secretagogue or an insulin sensitizer may shed light on the~     mechanism of action of reported genetic associations.~   "
98940|NCT01762033|"~     This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™~     (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle),~     to subjects with refractory renal cell carcinoma (RCC) until the disease progresses.~     Subjects who have failed 3 prior treatments for RCC including vascular endothelial growth~     factor (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that~     cannot be surgically removed will be eligible for screening.~   "
98941|NCT01762020|"~     To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced~     by adjuvant radiation therapy in women with breast cancer.~   "
98942|NCT01762007|"~     Even successfully managed hypospadias without any complication, voiding problem could be~     developed due to the increased urethral resistance. The investigators are trying to analyze~     the effect of hypospadias operation on voiding function by checking the detrusor thickness~     and urinary nerve growth factor.~   "
99640|NCT01752894|"~     The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs.~     Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES~     implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement~     at 3 months~   "
98943|NCT01761994|"~     Continuous renal replacement therapy (CRRT) has been considered as an effective modality for~     renal replacement therapy in hemodynamically unstable patients within intensive care unit~     (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU~     patients often make it equivocal to use anticoagulation. This is a prospective randomized~     controlled study to show the difference in filter life span and adverse event between HF1000~     (nafamostat mesilate) group and M100 (heparin-free) group.~   "
98944|NCT01761981|"~     The purpose of this study is to create an institutional and population-based registry of~     Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological~     data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.~      This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in~     the population of HIBA in the Central Hospital, as well as the characteristics of clinical~     presentation and evolution.~   "
98945|NCT01761968|"~     This is a multicenter, open label, long-term study testing the long-term safety,~     tolerability and efficacy of Givinostat in patients with Polycythemia Vera, Essential~     Thrombocythemia, primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential~     Thrombocythemia Myelofibrosis following core protocols in chronic myeloproliferative~     neoplasms and/or patient-named compassionate use program (if regulated/allowed by the local~     regulations, e.g. for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a~     sperimentazione clinica published on G.U. n. 173 of 28 July 2003, and the following~     amendments). Patients will continue at their last tolerable dose and treatment schedule of~     Givinostat monotherapy. If patients previously received Givinostat in combination with other~     drugs during a core protocol or a compassionate use program (if regulated/allowed by the~     local regulations, e.g. for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a~     sperimentazione clinica published on G.U. n. 173 of 28 July 2003, and the following~     amendments), they will be treated at the last tolerable dose of the combination. Assessment~     of safety and efficacy will be performed at each quarterly visit and each visit will also~     include laboratory tests and ECG examination. During the visits the clinical benefit will be~     assessed by Investigator according to the revised European LeukemiaNet response criteria~     (for PV and ET) and EUMNET response criteria (for MF). The dose of Givinostat will be~     modified for protocol specified toxicities. The treatment may continue up to Marketing~     Authorization of Givinostat, currently planned in the next 5 years (note: only for Germany,~     this long-term study is initially limited up to 2 years of treatment). Patients may~     discontinue study treatment at any time and remain on study therapy as long as they derive~     clinical benefit. Safety will be monitored at each visit throughout the entire duration of~     the study. In case the approved label will not cover the whole study population, Givinostat~     will be provided by the Sponsor to those patients not fulfilling the criteria for the~     approved label of the drug that are still deriving benefit from Givinostat at the time of~     its commercial availability.~   "
98946|NCT01761955|"~     The purpose of this study is to evaluate the effects of regular low fat diary consumption on~     markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body~     composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance,~     blood pressure, insulin sensitivity and resting metabolic rate.~   "
98947|NCT01761942|"~     The purpose of this study is to determine whether omega -3 fatty acids are effective and~     safe in treating anorexia nervosa.~   "
98948|NCT01761929|"~     This is a prospective Phase II study.The purpose of this study is to monitor the side~     effects and treatment outcomes of delivering higher doses of radiation therapy to the~     tumour, while limiting the dose of radiation to the normal tissues. This will be done using~     a 5 day treatment schedule.~      The characteristics of patients whose disease remains confined to limited areas in the long~     term, compared with those who do not will also be described.~   "
98949|NCT01761916|"~     The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed~     scientifically. There are no reports in the literature and concrete enough to elucidate~     important issues, especially in the field of hypertension and pregnancy.~      Searches based on current evidence concentrate their focus on the diagnosis of hypertensive~     disorders and treatment of these diseases maternofetais repercussions. However, the~     prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia,~     the most effective treatment for the control of hypertensive crisis and metabolic and~     cardiovascular events after two years of termination of pregnancy require further~     clarification.~      The main idea for developing this research came from the clinical experience with the use of~     captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with~     severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of~     hypertensive crisis and keeping pressure levels. Following the technical standards of the~     institution and during his administration, there were reports of side effects such as dry~     cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved~     hindering control the use of hypotensive.~      Alternative therapy, clonidine began to be used in mothers with some restriction on the use~     of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not~     known yet is how long clonidine reduces high blood pressure and how long to leave stabilized~     compared to the use of captopril.~      There are no reports in the literature databases, no randomized clinical trials that prove~     the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this~     particular group of patients, even in comparison with other classes of antihypertensive~     drugs, especially captopril, to this purpose.~      The investigators' primary assumption is that clonidine has better effectiveness in~     decreasing the frequency of pressure peaks when compared with captopril.~   "
98950|NCT01761903|"~     In this study we are looking at primary focal dystonias, including dystonias of the limbs,~     eyes, jaw or face, neck, and vocal chords. This study will use magnet resonance imaging~     (MRI) to see how the brain reacts while resting and doing a finger-tapping task.~      The investigators will test the hypothesis that disturbances in functional connectivity~     within the motor, affective and cognitive basal ganglia networks in primary focal dystonia~     (PFD) underlie the motor and non-motor symptoms in this disorder.~   "
98951|NCT01761890|"~     The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored,~     prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with~     dasatinib. Patients will be followed for 5 years. This study will help the definition of~     guidelines for the treatment of CML patients in early phases.~      The primary objective of the study is to describe, in the clinical practice, the rate of~     events leading to permanent discontinuation after 2 years of treatment with dasatinib as~     frontline therapy in newly diagnosed CML patients.~   "
98952|NCT01761877|"~     This study has two purposes. One is to determine if daily sulindac decreases breast density;~     a risk factor for breast cancer development. The second is to determine whether sulindac~     reduces pain and stiffness associated with regular use of aromatase inhibitors given for the~     treatment of breast cancer.~   "
98973|NCT01761604|"~     The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily~     function and reduces quality of life. The sphenopalatine ganglion, located in the posterior~     part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking~     the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently~     in use to accomplish this are either cumbersome for the patient or invasive regarding the~     puncture of structures.~      The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator~     device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area.~     We are expecting that this new device will provide at least the same pain relief as the~     previously described approaches. However, this nasal applicator is intended to be an easy~     and non invasive method for office use.~   "
99846|NCT01750190|"~     The purpose of this study is to determine whether FG-4592 is safe and effective in the~     treatment of anemia in chronic kidney disease patients who are not on dialysis.~   "
98953|NCT01761864|"~     Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal~     anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal,~     cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in~     their risk of side effects. Opoid analgesics are sometimes used as an alternative for NSAIDs~     in patients with osteoarthritis. However, these drugs also can lead to serious adverse~     events. Simple analgesics are first line treatment in patients with osteoarthritis. NSAIDs~     and opoid analgesics should be avoided whenever possible.~      Farmaka (www.farmaka.be) is a non-profit organisation that operates a nationwide academic~     detailing service in Belgium since 2006. The academic detailing exists of face-to-face~     educational visits to general practitioners in their practice by a trained visitor with a~     medical science degree. The aim of these visits is to improve the quality of drug~     prescribing in primary care. Small scale experiments in the past showed that academic~     detailing can indeed improve prescribing behavior.~      The current study wants to examine if nationwide academic detailing on appropriate~     prescribing of analgesics for chronic pain in osteoarthritis results in a better GP's~     prescribing behavior.~      Another research question is whether physician-visitors have more influence on prescribing~     than non-physician visitors.~      It is also interesting to examine if the effect of a visit is larger if there exists a~     longstanding relationship between the academic detailer and the GP.~      About 4.000 general practices are located in a region where academic detailers of Farmaka~     are operational and have received a visit at least once before. All these practices will be~     divided into two study groups in a random manner.~      The first group of practices will belong to the treatment group. GP's from this group will~     be offered a face-to-face visit on appropriate prescribing of analgesics for chronic pain in~     osteoarthritis. The visits will take place between February and June 2013.~      The second group of practices will serve as a control group. GP's from these practices won't~     be offered any visit at all during the year 2013.~      Reimbursement data for all GP's are available by request from the Belgian Intermutualistic~     Agency (IMA). IMA data for 2013 will be available by the end of 2014. These data will allow~     comparison between the treatment and control group on the amound and type of prescriptions~     for analgesics in patients with chronic osteoarthritis pain.~      A comparison of the prescriptions of practices that participate in the study and the~     prescriptions of in practices that don't participate is also possible.~      The project is funded by the Federal Agency for Medicines and Health Products. We~     hypothesize that~        -  the academic detailing visits to GP practices on prescribing of analgesics for chronic~          pain in osteoarthritis will improve prescribing of analgesics by at least 5%~        -  the personal relation between the GP and the academic detailer, expressed as the number~          of previous visits, is an important effect modifier~   "
98954|NCT01761851|"~     Metabolic disorders and malnutrition are well known and have been reported in patients with~     chronic liver disease, but the relationship of energy metabolism and changes in nutritional~     status in patients on the waiting list for liver transplantation are unexplored. The aim of~     this study was to assess the resting energy expenditure (REE) of these patients, identifying~     the prevalence of hyper and hypometabolism. In addition, to assess if, malnutrition and~     clinical variables were associated with REE and metabolic disorders.~   "
98955|NCT01761838|"~     The purpose of this study is to compare changes in spinal stiffness and back muscle activity~     between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic~     participants. Additionally, the investigators wanted to compare the amount of lumbar~     degeneration between SMT responders, non-responders and asymptomatic participants. This~     study also determines if the presence of pain modifies post-SMT spinal stiffness and back~     muscle activity.~   "
98956|NCT01761825|"~     The purpose of this study is to determine whether Ivabradine is an effective treatment for~     postural tachycardia syndrome.~   "
98957|NCT01761812|"~     The purpose of this study is to determine the ability of several new MRI techniques (MR~     elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient~     diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients~     with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo~     MRI will also be conducted on the prostate specimen to obtain high resolution imaging~     correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators~     hypothesize that the addition of these three techniques will increase the accuracy,~     sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.~   "
98958|NCT01761799|"~     The primary research aim of this project is to test the effectiveness of a comprehensive,~     evidence-based vaccine promotion package implemented in the obstetric setting on increasing~     the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis~     vaccine.~   "
98959|NCT01761786|"~     Rationale: the use of antiplatelet drugs (i.e. clopidogrel, ticagrelor or prasugrel) is~     crucial in the treatment of patients undergoing percutaneous coronary intervention (PCI)~     with stent implantation to prevent atherothrombotic events. Ticagrelor and prasugrel are~     more effective in preventing atherothrombotic events, but with a higher risk of bleeding~     complications, compared to clopidogrel. Clopidogrel is converted into its active metabolite~     by CYP2C19. Carriers of the non functional CYP2C19*2 and *3 alleles have an impaired CYP2C19~     capacity, making clopidogrel less effective. For these subjects ticagrelor or prasugrel is~     an alternative.~      Objective: to assess the efficacy, safety and cost-effectiveness of the CYP2C19 genotype~     guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 and~     *3 allele and ticagrelor or prasugrel in carriers of a CYP2C19*2 and *3 allele in STEMI~     patients.~      Intervention: the intervention group will be genotyped for CYP2C19*2 and *3 allele variants~     within 48 hours after PCI. Carriers will receive either ticagrelor (90 mg twice daily) or~     prasugrel (10 mg once daily or 5 mg once daily if the patient is older than 75 years or has~     a body weight < 60 kg), according to local standards. Non-carriers will be treated with~     clopidogrel (75 mg once daily). The control group receives either ticagrelor or prasugrel,~     according to local standards at the same dosage as the CYP2C19*2 or *3 carriers in the~     intervention group. The antiplatelet drug will be continued for one year after PCI. The~     follow-up duration will be one year using follow-up questionnaires.~   "
98960|NCT01761773|"~     The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of~     cabozantinib in adult subjects with impaired renal function compared with healthy adult~     subjects. Another objective is to assess the safety and tolerability of cabozantinib in~     these adult subjects.~   "
98961|NCT01761760|"~     Investigators will be evaluating an online video-game-based smoking cessation intervention~     that will overcome barriers to treatment such as cost and sustainability. This videogame~     will be the first of its kind, based on an evidence-based intervention shown to promote~     smoking abstinence. The findings from this research will be of great public health~     significance because of the unprecedented reach and relatively low cost, as well as the~     potential for similar interventions to be developed for other health problems, such as~     alcohol or drug abuse and medication adherence for chronic illnesses~   "
98974|NCT01761591|"~     The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit~     and impact on resource utilization of percutaneous coronary interventions (PCI) with the~     Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS)~     implantable via direct stenting or after lesion pre-dilation, in patients with coronary~     lesions that are eligible for direct stenting and who are recruited and treated so as to~     reflect real-life routine practice.~   "
99950|NCT01749098|"~     To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal~     learning and memory, episodic memory and spatial working memory in healthy volunteers.~   "
98962|NCT01761747|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved ponatinib for use in patients, including people with your type of cancer.~      In order to participate on this study, it must first be determined whether or not a~     patient's lung or head and neck squamous cell cancer (SCC) has an alteration in FGFR kinase~     is made from an experimental test on your squamous cell cancer tissue sample. This~     experimental test is a genetic test or genotyping test, which is a method used to study~     a tumor's genes. The results are for research purposes only and are not considered genetic~     testing for the purpose of diagnosing medical conditions. Cancers develop as a result of~     changes that occur in human genetic material (DNA); these changes are called mutations or~     alterations. This experimental test gives no information about any of the genes in the~     normal cells of the patient's body, but it helps identify abnormal genes (like FGFR kinase~     mutations or alterations) usually found only in cancer cells. We will use this experimental~     test to determine whether or not a tumor contains a required alteration/mutation and thus~     may respond to ponatinib.~      Ponatinib is an investigational, oral anti-cancer drug designed to inhibit abnormal proteins~     found in cancer cells and may cause those cancer cells to die. In laboratory testing,~     ponatinib has been shown to inhibit a family of proteins called FGFR kinases, and this~     genetic alteration/mutation has been found in some squamous cell lung cancers. There is~     laboratory evidence that alterations/mutations in FGFR kinases in squamous cell lung cancers~     may be driving the growth of these tumors and that inhibiting these FGFR kinases with~     ponatinib may decrease or stop the growth of lung SCC.~      In this research study, we are looking to see if the study drug, ponatinib, can keep cancer~     from growing.~   "
98963|NCT01761734|"~     Influenza is an important and potentially preventable cause of morbidity and mortality, yet~     only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite~     influenza vaccination being widely recommended, effective, and safe. Influenza vaccination~     rates are even lower in racial/ethnic minority groups. In order to address the problem of~     low influenza vaccination rates in minority adults, we plan to build on the well-accepted~     practice of immunization recall-reminders and the emerging practice of using text message to~     pilot the feasibility of using text messaging to improve influenza vaccination coverage~     rates in a low health literacy, largely minority, publicly insured adult population.~   "
98964|NCT01761721|"~     The propose of this study is to describe recovery and experience of pain and health related~     quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial~     Cancer or Atypical Complex Hyperplasia.~   "
98965|NCT01761708|"~     Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired~     with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh~     technology have been developed for the specific indication of small ventral hernias; this~     technique is very attractive because the mesh can be introduced through a nearly invisible~     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the~     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No~     literature is available on the adequate size of mesh needed to repair a hernia defect of an~     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a~     large mesh device. Small hernias might benefit of repair with a small mesh device so no~     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size~     to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective~     cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes~     for the different sizes of hernia defects. The study was stopped prematurely because of the~     perception of an unacceptably high rate of mesh infection. This new study will~     retrospectively examine the incidence of mesh infection in all ventral hernias repaired with~     a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.~   "
98966|NCT01761695|"~     The investigators would like to propose a prospective longitudinal observational cohort~     study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan~     Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other~     retrospective analysis.~   "
98967|NCT01761682|"~     The investigators would like to propose a prospective longitudinal observational cohort~     study for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at~     Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other~     retrospective analysis.~   "
98968|NCT01761669|"~     Working hypothesis and aims: The aim of our study is to investigate whether vitamin D~     deficiency could cause increased thrombin generation and a hypercoagulable state healthy~     volunteers.~      Methods:~      In total 400 healthy volunteers are planned for inclusion in this trial. After signing an~     informed consent two blood samples will be obtained from each participant.~      Expected results: invastigator expect to find that volunteers with vitamin D deficiency will~     have thrombin generation curve compatible with hypercoagulable state and returning to normal~     after treatment with vitamin D~   "
98969|NCT01761656|"~     The purpose of this study is to determine whether preoperative loading dose atorvastatin can~     prevent perioperative myocardial infarction during angiography and main adverse cardiac~     events 1 month after operation in stable angina, unstable angina and acute non-ST-segment~     elevation myocardial infarction patients undergoing elective coronary angiography and PCI,~     and determine whether its mechanisms are associated with microcirculation resistance.~   "
98970|NCT01761643|"~     CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration~     project to determine if the use of a text-message based adherence intervention (iTAB)~     improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.~   "
98971|NCT01761630|"~     Asthma is a disease characterized by inflammation in the airways. The body naturally makes~     compounds that reduce inflammation. Unfortunately, for patients with severe asthma, the~     pathway these compounds use to reduce inflammation seems to be perturbed. Investigators have~     chosen to focus on the anti-inflammatory compounds called lipoxins and how they work through~     the ALX Axis, a name given to the ALX receptor pathway and its ligands. Work from the~     Brigham and Women's Hospital has suggested that in patients with severe asthma, the ALX axis~     may not work properly and therefore may not shut off inflammation as expected. Also, there~     is information to suggest that in some cases, steroids (prednisone and similar drugs), which~     are commonly used to treat asthma, may affect the ALX axis in a negative way, paradoxically~     making the inflammation worse instead of better.~      As part of the NIH Severe Asthma Research Program the Asthma Research Center's goal is to~     identify what causes the problems in the ALX axis in severe asthma. To do so, participants~     with severe asthma will be compared to participants with milder forms of asthma.~     Investigators will use samples taken directly from the lungs of people with asthma, as well~     as blood, urine and CT scans of the lungs to better understand how the ALX axis changes both~     before and after corticosteroid treatment and throughout a three year span. Participants~     will come into the Asthma Research Center to have the procedures done.~      Investigators expect participants will perform breathing tests and complete questionnaires~     and diaries. To better understand if corticosteroids negatively affect the ALX axis in~     severe asthma, researchers will take samples before and after a one time steroid injection~     equivalent to a prednisone treatment for asthma. Participants will perform two bronchoscopy~     procedures, before and after corticosteroid treatment, where biopsies and cells will be~     obtained from the participant's lungs. Investigators will use these samples to observe any~     changes that the corticosteroid may have on the ALX axis. At the end of the study,~     researchers at the Brigham and Women's Hospital expect to understand the ALX axis in such a~     way that will allow them to formulate new therapies and drug targets to treat people with~     asthma, especially severe asthma, more effectively.~      In Boston, this study will be run together by the Asthma Research Center at the Brigham and~     Women's Hospital (adults) and Boston Children's Hospital (children).~   "
140453|NCT01216371|"~     The aim ist to identify biomarkers in the blood, to indicate early response or early~     treatment resistance.~   "
98977|NCT01761552|"~     To demonstrate that the use of Sugammadex enables physicians to perform early extubation in~     the operating room in ASA 4 & 4E patients~      Primary endpoint:~      • Extubation in the operating room before transfer to the PACU or ICU versus keeping the~     patient intubated when transferred.~      Secondary endpoints:~      • Time to extubation - measure the difference in time from application of the surgical~     dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery,~     on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine~     practice at Hadassa hospital for ASA IV patients.)~   "
98978|NCT01761539|"~     Fluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is~     associated with necrosis. However, there is insufficient evidence to support whether~     resuscitation should be moderate or aggressive. In this study the investigators aim to~     compare the clinical outcome associated with these strategies in a clinical randomized~     fashion to determine the optimal treatment of acute pancreatitis.~   "
98979|NCT01761526|"~     To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese~     and Caucasian Female and Male Healthy Subjects.~   "
98980|NCT01761513|"~     A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of~     YH4808 after repeated Oral administration and Postprandial state in healthy volunteers~   "
98981|NCT01761500|"~     Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This~     study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol~     in Chinese children and adolescents with Non-Hodgkin's lymphoma.~   "
98982|NCT01761487|"~     There is an urgent need to control the current national outbreak of Carbapenem-resistent~     Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times~     higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%,~     respectively).~      In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial~     of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for~     Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the~     investigators have shown that the investigators' SDD regimen is effective for decolonization~     patients colonized with CRKP.~      The investigators' assumption is that a higher dose of polymyxin E together with gentamicin~     (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of~     drug inactivation in the gut, thereby reaching CRKP carriage eradication.~   "
98983|NCT01761474|"~     Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause~     abdominal pain and discomfort. Some clinical trials have indicated, using the visual~     analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of~     patients without complications, compared with air insufflation. However, differences in~     patient suffering between CO2 and air insufflation after ERCP depending on sedation~     protocols have not been reported. We therefore planned prospective, double-blind,~     randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation~     protocol.~   "
98984|NCT01761461|"~     The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to~     compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.~   "
98985|NCT01761448|"~     The object of this study is to determine the improvement obtained in long-term adherence to~     home-based rehabilitation programs (cardiac rehabilitation phase III) when following a~     guided exercise training prescription supervised by an innovative system specifically~     designed to optimize the training effects and maximize the patient´s security compared to~     the standard care given in each country for this kind of patients. The innovated Guided~     Exercise- (GEx)- System consists of a sensor that monitors vital parameters during exercise~     training sessions used in combination with software that provides feedback to the patient~     based on the training prescription provided by the doctor and the level exertion monitored.~     This main trial follows a pretrial in which the used ECG sensor was validated at hospital~     during rehabilitation phase II and the practicability of the vest with this integrated ECG~     sensor and the possibility of technical problems of this innovative GEx- system were tested~     in real-life of the patient during phase III at home (ID 11-094).~   "
98986|NCT01761435|"~     Randomized, multicenter, open label trial to compare safety and efficacy of two doses~     stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.~   "
98987|NCT01761422|"~     The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for~     myocardial inflammation.~   "
98988|NCT01761409|"~     Endometrial cancer is one of the most common gynecological cancers, and the incidence~     increasing in the world. However, there isn't any large sample data of endometrial cancer~     reported in China. Thus Endometrial cancer project of Guangdong province conduct a large~     multicentre clinical investigation about endometrial cancer.~   "
98989|NCT01761396|"~     This research is being done to compare two types of talk therapy to see which is most~     effective in helping school children with anxiety disorders. The investigators will compare~     usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered~     by the school mental health counselors to see if they help children with anxiety disorders~     to feel less scared or worried.~   "
98990|NCT01761383|"~     The purpose of this study is to determine whether the use of Nintendo Wii will help improve~     negative symptoms of Schizophrenia and quality of life of patients with chronic~     Schizophrenia.~   "
98991|NCT01761370|"~     The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in~     the treatment of patients with Non alcoholic Steatohepatitis (NASH).~   "
98992|NCT01761357|"~     The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G~     (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related~     quality of life measured by questionnaire called SF-36, six months after a transcatheter~     aortic valve replacement in older patients. During the comprehensive geriatric assessment~     realized before the valve implantation, the following data are recorded and their impact of~     the health related quality of life will also be analysed: comorbidity, age, depression,~     functional status, the cognitive impairment and malnutrition.~   "
99358|NCT01756573|"~     Effect of dexamethasone on prolonging upper extremity block is well known. But it not known~     if the effect comes from its local effect on the nerves or from its general analgesic~     effect. In this study we will compare the systemic effect to its local effect to find out if~     there is a difference or not.~   "
98993|NCT01761344|"~     Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and~     blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary~     hypertension. The overproduction of aldosteron might in some cases be due to unilateral~     hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these~     cases the adrenal can be removed and the patient cured of hypertension. The clinical~     evaluation of patients with confirmed primary hyperaldosteronism therefore includes~     selective sampling of blood from the adrenal veins to determine lateralization of~     overproduction. This is executed as an interventional radiological procedure.~      The adrenal vein sampling is challenging, and success is determined by measuring another~     adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample.~     By routine laboratory assays the procedure is evaluated after the patient has been~     discharged from the hospital. In the study a rapid assay of cortisol will be evaluated,~     allowing the radiologist to draw new samples during the same procedure if the first set of~     samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol~     is a useful tool to evaluate successful sampling, and that fewer patients will need a~     repeated procedure.~   "
98994|NCT01761331|"~     The purpose of this prospective randomized three armed, multi center study is to compare the~     effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with~     infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get~     individualized acupuncture in different points according to symptoms and group C will not~     get acupuncture. Parents (who register the infants crying) and the nurse they meet at the~     study CHC are blinded.~   "
98995|NCT01761318|"~     The most important cause of mortality amongst DM2 patients is cardiovascular disease. An~     early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction.~     Diastolic dysfunction is an independent predictor of mortality and has been shown to improve~     in patients on a low calorie diet. The improvement of diastolic function was associated with~     a reduction in triglyceride accumulation in the heart and liver. A relatively new widely~     prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a~     Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood~     pressure and body weight. Next to the induction of weight loss, which is potentially~     beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on~     the cardiovascular system. However, the effect of Liraglutide on cardiovascular function has~     not been investigated yet. The investigators hypothesize that treatment of DM2 patients with~     Liraglutide is associated with improvement of cardiovascular function and a reduction of~     triglyceride accumulation in end-organs.~   "
98996|NCT01761305|"~     Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in~     children. Recent reviews on bracing and exercise treatment have provided some evidence for~     effect of these interventions. The purpose of this study is to compare the effectiveness of~     night time bracing, scoliosis specific exercises and physical activity prescription in~     adolescents with idiopathic scoliosis.~   "
98997|NCT01761292|"~     This is a 2-part, phase 2 study to assess the effects of Givinostat on muscle histologic~     parameters and on clinical parameters in ambulant children with DMD. The safety,~     tolerability, and pharmacokinetics of Givinostat will also be assessed. All children treated~     in part 2 continue in the extension phase, for a maximum of an additional 12 months.~   "
98998|NCT01761279|"~     Current standard practice is to remove all colonic polyps found during colonoscopy as it has~     not been possible to distinguish between polyps with some malignant potential (adenomatous)~     and those with negligable malignant potential (non-adenomatous).~      Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish~     between these two types of polyps by examining minute surface details.~      i-Scan is a new digital enhancement method that aims to enhance surface details and may~     enable similar accurate distinction between adenomatous and non-adenomatous polyps.~      Hypothesis:~      High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo~     assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.~   "
98999|NCT01761266|"~     E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to~     compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic~     treatment in subjects with unresectable Hepatocellular Carcinoma (HCC).~   "
99000|NCT01761253|"~     This study will involve the evaluation of the cost profile of about approximately 241,000~     patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network~     AND 226,000 members of a large self insured union trust fund). We will test the hypothesis~     that as comorbidity scores exceed three-four, patients will have an exponential increase in~     average yearly cost with a parallel exponential increase in cost variability.~      We will examine the relationship between comorbidity and health insurance costs and~     variability in costs among patients enrolled in health plans.~   "
99001|NCT01761240|"~     This study is a Phase I, first in human, dose-escalation study of MORAb-066, an~     investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets~     TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell~     lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety,~     tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will~     identify the MTD when MORAb-066 is administered IV once weekly on a 28-day cycle.~   "
99002|NCT01761227|"~     Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen~     Tablets in patients with mild to moderate vascular dementia (VaD).~   "
99003|NCT01761214|"~     Bronchiectasis is a chronic disease arises from progressive airway inflammation and~     infection. It has been postulated that bacterial infection triggers intense airway~     inflammation leading to acute exacerbation of bronchiectasis. Antibiotics have been the most~     potent medications for the treatment of bronchiectasis, however, the sputum bacterial load~     and inflammatory indices at steady-state and exacerbation remain largely unknown. The~     investigation might shed light on the roles that antibiotics play in acute exacerbation of~     bronchiectasis and uncover the mechanisms on why a subgroup of individuals do not respond~     satisfactorily.~   "
99120|NCT01759693|"~     Platelets are blood cells that are important in coagulation of the blood. These cells have~     recently been shown to play a role in a number of other biologic processes, for example~     inflammation. In this study the investigators will determine the extent of platelet~     activation in people suffering from common chronic skin inflammation-urticaria and allergic~     dermatitis.~   "
99004|NCT01761201|"~     A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing~     levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients~     eligible for liver transplantation.~      Patients over 18 years of age on the waiting list for liver transplantation.~      Sample size: n=870 patients.~      HYPOTHESIS~      Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for~     liver transplantation, is safer and not less effective than isoniazid treatment begun after~     transplantation when liver function is stable.~   "
99005|NCT01761188|"~     -  Background:the ablation outcomes for the treatment of persistent atrial fibrillation~          are not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We~          found a new novel strategy for the modification of LA substrate during sinus rhythm~          based on our pilot study.~        -  Hypothesis: our new method may be more effective than conventional strategy.~        -  Objectives:The primary objective of this investigation is to compare the efficacy of~          two different AF ablation strategies in patients with persistent AF:Study Group: CPVI~          plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (~          STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines~          +CFE) .The secondary objectives of this investigation are to evaluate and compare the~          safety and procedural characteristics of both groups.~        -  Sample size: 220~        -  Time line: 2013 Q1-2014 Q2~   "
99006|NCT01761175|"~     The purpose of this study is to compare the rate of complete sensory block at 30 minutes~     following ultrasound-guided single injection infraclavicular block and ultrasound-guided~     double injection axillary block. The investigators research hypothesis is that both blocks~     will show comparable rates of complete sensory block at 30 minutes.~   "
99007|NCT01761162|"~     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI~     Pacemaker System when used under specific MRI conditions.~   "
99008|NCT01761149|"~     Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil~     (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however~     suggests that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus,~     the present study is designed as a proof of principle study and hypothesizes that higher~     dose of remifentanil may reduce postoperative pain in patients.~   "
99009|NCT01761136|"~     The objective of this study was to evaluate the safety and immunogenicity of Haemophilus~     influenzae type b vaccine in different injection site.~   "
99010|NCT01761123|"~     the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an~     adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using~     a radio controlled capsule. The secondary objective is to evaluate the immune response~     (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.~   "
99011|NCT01761110|"~     The main goal of this study is to pilot test the community-based buprenorphine treatment~     (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk~     behaviors. Two groups of participants will be followed for 60 days, with 3 research visits.~     One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group~     after the CBBT intervention (post-intervention). Data sources will include questionnaires,~     urine toxicology tests, and medical record data. We hypothesize that compared to the~     participants in the pre-intervention group, participants in the post-intervention group will~     be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk~     HIV risk behaviors.~   "
99012|NCT01761097|"~     Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of~     cancer at an early stage, as well as detection and removal of polyps through gold standard~     colonoscopy examination decreases mortality from the disease. However colonoscopy has a well~     documented miss rate, with some areas of the bowel difficult to visualise and neoplastic~     lesions potentially hidden behind folds in the colon.~      The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten~     mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled~     withdrawal and improving mucosal visualization. The cap easily attaches to the tip of~     current colonoscopes without modification. In this single centre, randomised controlled~     trial, the investigators aim to assess the performance of the current gold standard~     colonoscopic examination against the current gold standard colonoscopic examination with the~     Endocuff© attached to the colonoscope.~      The investigators aim to recruit 300 patients (150 in each group) who have previously been~     identified to have colonic polyps or cancers undergoing surveillance colonoscopy following~     NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on~     gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator~     guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or~     cancer will be invited to participate and those agreeing will be randomly allocated to one~     or other technique.~   "
99013|NCT01761084|"~     The long-term goal of our research team is to conduct a large multicentre study to evaluate~     whether tailored home exercise can prevent fractures in high-risk individuals. The proposed~     project will address the feasibility of such a trial, but will also evaluate the effect of~     exercise on quality of life, posture and many other outcomes important to individuals with~     vertebral fractures. Physiotherapists will conduct 6 home visits with participants to~     deliver the intervention (or social visit for controls) using a similar model to previous~     work by our team and others. The purpose of this pilot study is determining the feasibility~     of recruitment, retention and adherence of an international multicentre randomized~     controlled study evaluating the efficacy of thrice-weekly home exercise for one year among~     women with vertebral fracture. As secondary objectives, the investigators will examine the~     effects of exercise on function, balance, quality of life, pain, falls and fractures. The~     primary hypothesis is that the investigators will successfully recruit and retain the target~     sample, and achieve an adherence rate of 60%.~   "
99014|NCT01761071|"~     The investigators performed this study to investigate pain prevention of preoperative~     topical nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK)~     using time serial pain scoring.~   "
99015|NCT01761058|"~     The overall goal of this proposal is to better understand the basis of airway remodeling in~     severe asthma and how remodeling changes overtime. The investigators propose to study a well~     characterized cohort of individuals with severe asthma using a multidisciplinary~     state-of-the-art-approach.~   "
99018|NCT01761019|"~     Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective~     when used as monotherapy (without other oral medicines or creams) than are newer biologic~     injected drugs. However, these oral medications are also less expensive than biologic agents~     and may be safer for use in some patients. The purpose of this study is to determine if~     adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension~     (Taclonex topical suspension), will improve the severity of psoriasis in patients already on~     methotrexate or acitretin and to determine if adding this topical suspension will reduce the~     desire of such patients to switch to a biologic agent to treat their psoriasis.~   "
99019|NCT01761006|"~     The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes~     up during an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and~     whether the level of exhaled nitric oxide returns to normal in the weeks after an~     exacerbation.~   "
99020|NCT01760993|"~     The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80,~     100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.~   "
99021|NCT01760980|"~     The objective of this study is to assess the bioequivalence of the test product, Exemestane~     25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin®~     (exemestane) 25 mg tablets of Pharmacia & Upjohn Company, Division of Pfizer Inc., New York,~     United States of America in healthy male and postmenopausal female subjects, under fasting~     conditions~   "
99022|NCT01760967|"~     Background:~      Dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique~     sedative agent which causes less acute tolerance, drug addiction and withdrawal compared~     with gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU~     sedation in 2004 in Japan, and it has been used particularly for surgical ICU patients. In~     August 2010 dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.~      Recent evidence demonstrated that dexmedetomidine has organ protective effects including~     neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and~     anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct~     size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning~     effect against ischemic injury in hippocampal slices, and this result was considered an~     apoptosis suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine~     enhanced the spontaneous contractions of the ileum in peritonitis rats compared with~     propofol and midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced~     high mortality rates and the plasma cytokine concentrations, interleukin-6 and tumor~     necrosis factor alpha in endotoxemic rats.~      A meta-analysis has shown that perioperative alfa2-adrenergic agonists, including~     dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac~     surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine~     output, reduction in serum creatinine, and the suppression of diuretics in a randomized~     placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had~     improved 28-day mortality rates compared with septic patients receiving lorazepam in a~     sub-group analysis of MENDS randomized controlled trial.~      These positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys,~     gastrointestinal tract action, and an anti-inflammatory action, are expected to improve~     mortality in septic patients. However, large clinical research studies have not been~     conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU~     Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical~     outcome and has these organ protective effects on septic patients.~      Objective:~      To determine whether dexmedetomidine improves clinical outcome and has organ protective~     effects on septic patients.~   "
99023|NCT01760954|"~     A randomized study evaluating the continued safety and efficacy of elagolix in the~     management of moderate to severe endometriosis-associated pain in adult pre-menopausal~     female subjects.~   "
99024|NCT01760941|"~     This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400~     flat rate, same-day consultation, simulation, and delivery of a single fraction of~     palliative radiation therapy for patients with symptomatic bony metastatic disease who are~     currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy~     will utilize standard of care techniques.~   "
99025|NCT01760928|"~     A selection of asthma patients were followed during preparation to climb the Aconcagua~     mountain. The primary goal of this follow up was to optimize patients' asthma status. Also~     during expedition, these patients were daily consulted by a physician. All data obtained~     during preparation and expedition will now be retrospectively analyzed.~   "
99026|NCT01760915|"~     The overall goal of this proposal is to better understand the basis of structural airway~     changes in severe asthma and how asthma exacerbations may contribute to their progression~     over time. The investigators propose to study a well-characterized cohort of adult and~     pediatric subjects with asthma using a multidisciplinary state-of-the-art approach. We~     hypothesize that severe asthma exacerbations, in some patients, are associated with~     incomplete recovery and activation of airway inflammatory cells in a regional distribution.~     The end result is a more permanent and less reversible airway obstruction that is a~     prominent feature of severe asthma.~   "
99027|NCT01760902|"~     South Carolina has many gaps in health status of our citizens. Some of the biggest gaps are~     higher cancer rates among African Americans. The purpose of this study is to find people who~     have increased inflammation and study how well a community-based dietary and physical~     activity program works at reducing the risk of African Americans developing~     inflammation-related diseases.~   "
99028|NCT01760889|"~     The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or~     100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative~     Symptoms.~   "
99029|NCT01760876|"~     Since polymers have been identified as a possible cause of late complications of drug~     eluting stents, new stents are being designed to improve polymers' biocompatibility or to~     bond drugs on stents without polymers.~      Biolimus A9 is the therapeutic agent used in the BioFreedom drug coated stent. Biolimus A9~     is a proprietary semi-synthetic sirolimus derivative. It is highly lipophilic, rapidly~     absorbed in tissues, and able to reversibly inhibit growth factor-stimulated cell~     proliferation.~      In this study, we use intracoronary optical coherence tomography (OCT) to evaluate the~     BioFreedom Stents after implantation regarding endovascular healing over time as primary~     objective; and also to evaluate secondary OCT, angiographic and clinical outcomes at various~     specific time points.~   "
99030|NCT01760863|"~     The primary purpose of this study is to compare the re-infection rates in patients~     undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to~     those patients who received in-hospital perioperative antibiotic only. Patients will be~     monitored for re-infection following hospital discharge, defined as deep infection of the~     joint space/capsule that requires return to the operating room within 24-months of the~     re-implantation procedure.~   "
99031|NCT01760850|"~     This pilot clinical trial studies a breast and cervical cancer educational intervention for~     Latinas in Western New York. An outreach program may help minority cancer patients overcome~     problems that keep them from receiving cancer screening.~   "
99032|NCT01760837|"~     Based on the current knowledge, the investigators hypothesized that most children with milk~     allergy in Israel would be able to ingest baked milk products daily, thus benefiting from~     improved nutrition and dietary variety and protect them from accidental exposure to~     milk-containing products.~      Objective: The aim of our study is to examine the outcome of cow's milk allergic patients~     who incorporated baked milk products into their diets. In order to recruit a large~     population, a multicenter study across many hospital related allergy clinics in Israel will~     be conducted.~      Methods~      Participants The study protocol is essentially as described previously (12). Subjects will~     be recruited from the relevant allergy clinics involved in this project. The study will be~     approved by the local Institutional Review Board, and informed consent will be obtained.~      Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses~     or detectable serum milk-specific IgE, and had a history of an allergic reaction to milk~     within 6 months before study entry or milk-specific IgE levels or SPT responses greater than~     95% of predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L; if >2~     years old, a level >15 kUA/L; SPT mean wheal diameter, >8 mm.~      Exclusion criteria include a negative SPT response and an undetectable milk-specific IgE~     level; a history of anaphylaxis requiring intensive care unit hospitalization; unstable~     asthma or a history of intubation related to asthma; previously diagnosed milk-induced~     eosinophilic gastroenteropathy; a recent reaction (within 6 months) to a baked milk product;~     or pregnancy.~      Design~      Active group - Based on the results of the initial baked milk oral challenge, subjects will~     be categorized as baked milk reactive or baked milk tolerant (group I and II, respectively).~     Group I subjects will be instructed to completely avoid all forms of milk but will be~     offered a repeat challenge 6 or more months from the initial challenge. Group II subjects~     will be instructed to incorporate baked milk products daily into their diets and after 6 or~     more months will be offered challenges to baked cheese products (pizza). Similarly, after 6~     or more months, baked cheese-tolerant children will be offered challenges to unheated milk.~      The two groups will be followed at least 2 years and the outcome as well as other parameters~     (accidental exposure, use of medication, quality of life, appearance of related symptoms,~     ect) will be compared between the 2 groups.~      Baked milk - Each muffin (or the equivalent piece of cake) contains ~ 1.3 g of milk protein.~     The muffins/cake will be prepared according to instructed recipe and will be baked at 180~     degree C for 30 minutes. Baked milk-tolerant subjects will be instructed to ingest 1 to 3~     servings per day of store-bought baked milk products with milk listed as a minor ingredient~     (third or less) or home-baked products with an equivalent amount of milk protein.~      Baked cheese - Cheese pizza (Maadanot), will be baked at 2200 C for 13 minutes or longer.~     Baked cheese-tolerant subjects will be instructed to eat any brand of well-cooked cheese~     pizza 4 to 7 times weekly and limited to 1 daily serving.~      Unheated milk - Challenges will be performed with skim milk totaling 240 mL (or other~     product containing 8-10 g of unheated milk protein, such as yogurt).~      Follow-up allergy evaluations - Blood and serum samples will be collected for the~     measurement of IgE and IgG4 antibodies to milk, casein, and b-lactoglobulin by using UniCAP~     (Phadia, Uppsala, Sweden) as well as for T cell analyses. (This part is optional upon~     agreement of the parents).~      Un-blinded food challenges will be performed under a physician's supervision in the clinical~     research unit. Muffin and pizza will be administered in 4 equal portions over 1 hour.~     Unheated milk will be administered in gradually increasing doses. Subjects will be monitored~     throughout and for 2 to 4 hours after completion of the challenge. Challenges will be~     discontinued at the first objective sign of a reaction or due to convincing persistent~     subjective symptoms, and appropriate treatment will be initiated immediately.~   "
99033|NCT01760824|"~     Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major~     causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop~     peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori~     infection. The eradication rate of first line clarithromycin based therapy has fallen to~     below 80%. Both quadruple and sequential treatment regime has been proposed as the~     first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects~     between the two regime remained unknown. The aim of this clinical trial is to compare the~     efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus~     sequential therapy as empirical first and second line treatment.~   "
99034|NCT01760811|"~     To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment~     followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for~     advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501~     and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and~     cisplatin) with a similar stage of the disease.~   "
99035|NCT01760798|"~     Osteoporosis is characterized by decreased bone strength and it is prevalent among~     postmenopausal women but also occurs in men and women with underlying conditions or major~     risk factors associated with bone demineralization. Its chief clinical manifestations are~     vertebral and hip fractures, although fractures can occur at any skeletal site.The World~     Health Organization (WHO) operationally defines osteoporosis as a bone density that falls~     2.5 standard deviations (SD) below the mean for young healthy adults of the same gender—also~     referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young~     normal range (a T-score of >1 SD below the mean) are defined as having low bone density~     (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures,~     including hip fractures, among postmenopausal women occur in this group.~      Teriparatide is one of the most effective treatment options for osteoporosis. But the cost~     of teriparatide is prohibitively expensive and in countries like India with limited personal~     resources of the individuals, its not a feasible option in the majority of the patients with~     severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide~     therapy in an open label non inferiority trial and if successful, the investigators~     anticipate, the cost of treatment could be reduced considerably so that treatment becomes~     more affordable to a larger number of patients. Also with weekly therapy, number of multiple~     injections could be brought down.~   "
99036|NCT01760785|"~     Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or~     eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective~     lability following TBI. Observed clinically, the symptoms of poorly regulated affective~     expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an~     idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same~     natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for~     example. Instead, both symptoms and course appear more characteristic of the sustained~     affect lability often observed following TBI. This observation suggests that TBI survivors~     represent a patient group for whom treatment of neuropsychiatric symptoms following TBI may~     alleviate both TBI-related affect lability and also heavy ethanol use by treating the~     condition that is contextually related to excessive alcohol use.~      Based on this concept of consequently treating AA/D through the management of post-TBI~     affective lability, this study was conducted observing the efficacy of divalproex sodium on~     the severity of affective lability and AA/D in persons suffering from a moderate TBI.~     Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance~     abuse problems. This drug has also shown positive results as an alternate medication to~     benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the~     progression of withdrawal symptoms in patients.~   "
99037|NCT01760772|"~     Individuals with obesity have an increased risk for heart disease and diabetes. There are~     current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to~     treat diabetes. The investigators want to determine if targeting this hormone will also help~     people with high cholesterol and triglycerides. In this study, the investigators are looking~     at the role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.~   "
99038|NCT01760759|"~     In this study, investigators propose to randomize 165 human immunodeficiency virus positive~     patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care~     + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence~     reminders and contingency management. In this latter condition, patients will earn~     reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy~     medication ingestion. Primary outcomes will include viral loads and self-report measures of~     adherence, and effects will be evaluated both during the treatment period and throughout a~     one-year follow-up. Investigators hypothesize that the cell phone reminder condition will~     improve adherence relative to standard care, and the cell phone reminder plus contingency~     management condition will have the best outcomes. Results from this study may have~     widespread implications for the use of cell phones as a novel technology to improve initial~     adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human~     immunodeficiency virus strains to the community.~   "
99039|NCT01760746|"~     PDR is a leading cause of irreversible vision loss in North America. This disease is caused~     by the growth of abnormal blood vessels in the retina. These abnormal blood vessels can~     bleed inside the eye, causing a vitreous hemorrhage (VH). Sometimes when patients have this~     bleeding, a surgery called vitrectomy is required to remove the blood from within the eye.~     In order to reduce complications during the surgery, most retina surgeons will inject~     Avastin into the eye a few days before the surgery.~      Avastin (bevacizumab) is currently not approved by Health Canada to treat any ocular~     disease. Lucentis (ranibizumab) is approved by Health Canada as a treatment for age-related~     macular degeneration, diabetic macular edema, and retinal venous occlusive disease. While~     Avastin is not approved by Health Canada for the treatment of these diseases, the majority~     of retina specialists around the world are now using Avastin off-label to treat these~     diseases. That is because Avastin and Lucentis both tend to work equally well in these~     disease, but Avastin is significantly cheaper. While Avastin and Lucentis are generally~     regarded to be equal, there may be some differences between these two drugs that have not~     been discovered. The aim of this study is to look for these differences.~      Previous research by the investigators in this study has shown that injecting Avastin into~     eyes causes increased inflammatory proteins to develop inside the eye. This increase in~     these proteins was related to complications that developed after the vitrectomy surgery.~     Lucentis may be associated with less of an increase in inflammatory proteins (and less~     complications). The aim of this study will be to compare Avastin and Lucentis with respect~     to how they affect inflammatory proteins in the eye, as well as the rate of complications~     during surgery.~      Study participants will be divided into two arms (groups) of 30 subjects. Subjects will~     receive Avastin or Lucentis a few days before vitrectomy surgery. The assignment will be~     random and the study is double-masked. Masking is done so that the investigators can clearly~     determine any differences between the 2 drugs.~   "
99040|NCT01760733|"~     Kidney transplantation has been shown to provide improved survival even in patients older~     than 70 years of age. The purpose of the study is to determine whether kidney~     transplantation provides any improvement of health related quality of life (HRQOL) in~     patients over the age of 65 years. HRQOL wil be monitored using the Kidney Disease and~     Quality of Life (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the~     Norwegian transplant wait list and followed every 6 months until transplantation. Thereafter~     a new form will be completed after 10 weeks postv transplant, 6 months, 1 year, 3 years and~     5 years. In addition the study will explore the transplant candidates expectations in a~     qualitative study design and explore the relationship between pre-transplant comorbidity,~     HRQOL and survival.~   "
99041|NCT01760720|"~     Based on our previous success with the intervention pilot (R34MH083512), we conducted this~     randomized controlled trial (MMT CARE), which will integrate behavioral intervention~     components with a primarily pharmacological model of MMT. The intervention focuses on~     treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors~     among service providers, enhancing their communication skills, and improving their~     interactions with and support of their clients' behavior changes. Our goal is to bring a~     contextual change to support a protective environment for clients' motivation and capacity~     in order to reduce their HIV risk. The findings could benefit not only China but also the~     global community by effectively combining interventions for controlling the HIV epidemic.~   "
99042|NCT01760707|"~     The purpose of the study was to investigate the effects of training on the exercise~     capability, balance performance, and microcirculation. Furthermore, to search the possible~     underlying mechanisms.~   "
99043|NCT01760694|"~     To assess the ability of a combination of updated and approved modalities in the treatment~     of first line pancreatic cancer patients to increase the time to Progression Free Survival~   "
99044|NCT01760681|"~     The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison~     to a sham H-Coil rTMS in older patients with treatment-resistant major depressive~     disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute~     treatment phase will last four weeks. Treatment is administered daily, 5 days per week~     (i.e., 20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects~     achieve the pre-defined primary outcome criteria of remission (HDRS-24 score < 10 and 60%~     reduction in symptoms) they will continue with twice weekly treatment for two more weeks to~     ensure the durability of the remission. Subjects who do not achieve remission will exit the~     study after the acute treatment phase of four weeks. The blind will not be broken to~     subjects until the completion of the study~   "
99045|NCT01760668|"~     The study aim is:~        1. To examine aortic tissue by light microscopy~        2. To examine aortic tissue by electron microscopy~        3. To study changes in the epigenome and transcriptome of the X chromosome specific to~          aortic tissue.~        4. To examine aortic tissue using biochemistry including proteomics.~        5. To establish the karyotype of fibroblasts with standard chromosome examination on 10~          meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering~          the X and Y chromosome. Using the latter 200 meta-phases will be examined.~      30 controls who did not die from aortic dissection or dilation will be recruited from The~     Department of Forensic Medicine at Aarhus University Hospital.~      The investigators will subject samples of aortic tissue from women undergoing prophylactic~     aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of~     examinations (except karyotyping). Lastly the investigators will compare the results from~     the three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).~   "
99046|NCT01760655|"~     This clinical trial studies reduced-intensity conditioning before donor stem cell transplant~     in treating patients with high-risk hematologic malignancies. Giving low-doses of~     chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the~     growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the~     donor's T cells (donor lymphocyte infusion) after the transplant may help increase this~     effect.~   "
99047|NCT01760642|"~     Identification and evaluation of endogenous markers for the assessment of CYP3A activity in~     female subjects using metabolomics~   "
99048|NCT01760629|"~     Whole body cooling improves survival with normal neurological outcome after neonatal~     encephalopathy in high-income countries. However, cooling equipments used in the high-income~     countries are expensive and unsuitable for wider use in low and middle-income countries~     (LMIC). We had previously conducted a randomised controlled trial of whole body cooling~     using phase changing material in south India. Although cooling was provided, there were wide~     temperature fluctuations.~      Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in~     administering effective and stable whole body cooling in encephalopathic infants.~      Methods: After informed parental consent (and ethical approvals), we will administer 72~     hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic~     infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras~     Medical College, over a six month period. To induce cooling, the infants will be kept on the~     cooling mattress. Temperature will be continuously measured for 80 hours using a rectal~     probe connected to a digital data logger.~      The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for~     which the temperature remains between 33 to 340C during the intended cooling period.~   "
99049|NCT01760616|"~     To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression~     of hepatocarcinoma after non-radical hepatectomy.~   "
99050|NCT01760603|"~     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous~     fascia fixation procedure is developed in China for vaginal apex fixation with native~     tissue.~      This study is designed to determine the effectiveness and safety of ischia spinous fascia~     fixation procedure for the treatment of pelvic organ prolapse stage III.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
99051|NCT01760590|"~     The purpose of this research is to compare the effects of two commonly used, safe, thoracic~     spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in~     individuals with nontraumatic cervical pain. The immediate effects of thoracic spine~     mobilization have been shown to facilitate greater range of motion increases in the cervical~     spine and greater pain decreases within a treatment session and on follow-up visits. There~     is no research utilizing pain threshold perception as an objective outcome of these~     treatments. Only one study compared the two treatment techniques and concluded that future~     research should be completed which includes manual therapy for the thoracic spine. (Cleland~     2007)~   "
99052|NCT01760577|"~     The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A~     versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle~     osteoarthritis.~   "
99053|NCT01760564|"~     To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type~     C patients.~   "
99054|NCT01760551|"~     The American Medical Association's (AMA) Guides to the Evaluation of Permanent Impairment is~     used to rate loss of function and determine compensation and ability to work after injury or~     illness. The AMA Guides are used by many different systems to determine compensable levels~     of impairment. However, there are few studies that evaluate reliability or construct~     validity. (1) In the professional community there exists considerable controversy regarding~     the accuracy and usefulness of the AMA Guides. (2,3) Commentaries have noted that the AMA~     Guides do not provide a valid, reliable, evidence-based system for the rating of~     impairments. (4) Some have argued that the impairment ratings do not reflect an individual's~     actual loss of function and quality of life (QOL). The AMA guides 5th edition was based on~     loss of range of motion (ROM). The new 6th edition of the AMA guides is based on diagnosis~     and inclusion of functional outcomes assessments in the determination of impairment ratings.~     (5) In the orthopaedic literature the use of patient-derived, objective outcome measures has~     substantially expanded QOL instruments are categorized as general health or as~     condition-specific questionnaires. The Medical Outcomes Study 36-Item Short Form (SF-36) is~     a general health-based survey of quality of life. It has been validated and is used widely~     across medical disciplines. (6) The SF-36 was constructed to survey health status in the~     Medical Outcomes Study. It was designed for use in clinical practice and research, health~     policy evaluations, and general population surveys. The SF-36 was constructed for~     self-administration by persons 14 years of age and older, and for administration by a~     trained interviewer in person or by telephone. (7) The SF-36 is perhaps the most widely used~     health-related quality of life (HRQoL) survey instrument in the world today. It is comprised~     of 36 items that assess eight health concepts: physical functioning, role limitations caused~     by physical health problems, role limitations caused by emotional problems, social~     functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.~     Physical and mental health summary scores are also derived from the eight RAND-36 scales.~     (8) The aim of this study is to determine the amount of correlation between the by~     orthopaedic surgeon objectively calculated percentage of impairment scored by the American~     Medical Association guides to the evaluation of permanent impairment and the by patient~     subjectively indicated health-related quality of life scored by the SF-36.~      Hypotheses: Because of and inclusion of functional outcomes assessments in the determination~     of impairment ratings the AMA guide 6th edition will have a better correlation with the~     SF-36. The 6th edition of the AMA guide is based on diagnosis en yield lower impairment~     percentages than the AMA guide 5th edition that is based on loss of ROM. The SF-36 will have~     better correlation with the impairment ratings for lower extremities injuries than for upper~     extremities because it is less valid for the upper extremities.~   "
99055|NCT01760538|"~     The purpose of the study was to investigate the changes on heart rate variability, exercise~     capacity, activities of daily living, and quality of life after aerobic exercise training in~     cardiac transplant recipients.~   "
99056|NCT01760525|"~     This is a first in human phase I study of single agent CGM097 in patients with advanced~     solid tumors who have progressed despite standard therapy or for whom no standard therapy~     exists. The tumor must be characterized by p53wt status. The study consists of a dose~     escalation part where patients will receive escalating doses of CGM097, and a dose expansion~     part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended~     Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation~     from an adaptive Bayesian logistic regression model (BLRM).~   "
99057|NCT01760512|"~     The purpose of this study is to gather clinical and economic evidence on the use of robotics~     for bariatric surgery (gastric bypass).~      This monocentric, randomized, single blind, controlled study will evaluate post-operative~     pain, quality of life and appetite, post-operative complication incidence. It will also~     provide information on direct and indirect costs of surgery.~   "
99058|NCT01760499|"~     The main purpose of this study is to find out more about how PV-10 works in melanoma tumors.~     Researchers also want to find out if there are changes in the body's immune cells (cells~     that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors~     and circulating in the blood.~   "
99059|NCT01760486|"~     The investigators have shown that adding an internet behavioral weight loss program to a~     statewide campaign improves weight loss outcomes. However, our follow-up data suggest that~     once the intervention is stopped, participants begin to experience weight regain. Thus, the~     purpose of this project is extend this line of work and pilot test health coaches and~     monetary incentives for weight loss maintenance. The investigators hypothesize that coaching~     and incentives will improve longer-term weight outcomes.~   "
99060|NCT01760473|"~     The study is designed to compare the abuse liabilities of intranasal buprenorphine and~     buprenorphine/naloxone in individuals who are physically dependent on sublingual~     buprenorphine. The investigators hypothesize that the abuse liability of~     buprenorphine/naloxone is lower than that of buprenorphine alone.~   "
99061|NCT01760460|"~     This study will evaluate the effects of anacetrapib (MK-0859) on low-density~     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with~     dyslipidemia when added to an existing statin-modifying therapy.~   "
99062|NCT01760447|"~     The purpose of this study is to assess the safety and efficacy of the addition of~     sitagliptin (administered as MK-0431A XR) compared with the addition of placebo to therapy~     with extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus~     (T2DM) in pediatric participants with inadequate glycemic control on metformin therapy~     (alone or in combination with insulin). The primary hypothesis is that the addition of~     sitagliptin reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of~     treatment.~   "
99063|NCT01760434|"~     Evaluate the long-term outcomes following operative and nonoperative treatment of childhood~     scoliosis.~   "
99064|NCT01760421|"~     Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation~     of thyroid gland and destroys thyroid tissue.~      Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of~     several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid~     arthritis(RA) for more than one century.~      The purpose of this study is to evaluate whether hydroxychloroquine is effective in~     treatment of Hashimoto's thyroiditis.~   "
99164|NCT01759121|"~     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic~     efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL~     endpoint management function for severe non-proliferative diabetic retinopathy.~   "
99065|NCT01760408|"~     The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based~     registry for nutrition care launched in early 2011, initially focusing on the home~     parenteral nutrition (HPN) patient population. The purpose of Sustain is to collect~     information regarding the patients and populations who require HPN in the United States,~     measure outcomes associated with HPN, allow institutional benchmarking against the aggregate~     data, and publish the findings to improve the quality of care for patients receiving HPN.~     The registry is open to all sites (hospital and home based) who care for new or existing HPN~     patients.~   "
99066|NCT01760395|"~     Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable~     complication rates, thousands of patients worldwide suffer from inguinal hernia surgery~     complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives~     reports from surgical complications. In this study, the database of FPIC is used to compare~     the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.~   "
99067|NCT01760382|"~     Myocardial infarction (MI) outcomes strictly depend on the time to reponed the~     infarct-related coronary artery. Networks have been activated in the last years in many~     countries to achieve fast track access of patients with ST-elevation MI to hospital with h24~     primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have~     been formally activated in Piedmont. The aim of our registry is to monitor the activity of~     the STEMI network in the large suburban area of Novara (population of about 800.000~     subjects).~   "
99068|NCT01760369|"~     The purpose of this study is to determine whether head rotation in prone positon affects~     regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.~   "
99069|NCT01760356|"~     To search for suitable pharmacodynamic biomarkers, i.e., with high specificity for~     calcineurin inhibition and most affected by inter-individual variability, our works aimed at~     exploring the pharmacodynamics of CNI, the strength and variability of signal translation~     along the calcineurin pathway, as well as the steps where sources of internal (genetic) or~     external variability are the most influential.~      In order to achieve this, we assessed simultaneously NFAT1 translocation into the nucleus of~     peripheral blood mononuclear cells (PBMC) (NFTA1 being the main NAFT isoform in resting and~     activated lymphocytes), the intracellular expression of IL-2 in CD3+, CD4+ and CD8+ T cell~     subsets and the membrane expression of CD25 (IL-2Rα), a surface marker of T cells~     activation, in T cells at large. A non-interventional clinical trial was set up in healthy~     volunteers, patients registered on a liver transplantation waiting list (WLP) and liver~     transplant recipients (LTR). A different question was addressed in each group: The healthy~     volunteer study (n=35): explored TAC PD along the calcineurin pathway by exposing PBMC~     ex-vivo; modelled signal translation along this cascade; examined the interindividual~     variability of TAC PD parameters; and investigated the sources of the variability observed~     and their contribution at each step of the calcineurin pathway. Furthermore, it allowed us~     to evaluate the analytical variability of our techniques as well as the intra-individual~     variability of TAC PD parameters. WLP (n=19) were enrolled to confirm in patients with liver~     diseases the results obtained in healthy volunteers, as well as to test the potential~     influence of their initial disease on the ex-vivo pharmacodynamics of TAC. The aims of the~     transversal study of LTR on CNI (n=80) were to further explore the interindividual~     variability in the PD of CNI in realistic clinical conditions, i.e. in situations of~     residual PD activities under tacrolimus or cyclosporine exposure, and the potential~     pharmacogenetic (PG) sources of such variability. The (still small) group of liver~     transplant patients (n=9) enrolled immediately before transplantation and followed-up with~     serial monitoring along the first year post-transplantation was intended to explore the~     relationships between CNI PD and clinical responses.~   "
99070|NCT01760343|"~     A new formulation of Berinert (CSL830) is being investigated for the management of~     hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single~     1500 IU dose of the new formulation of Berinert. This study will also look at the~     pharmacokinetics of CSL830 relative to Berinert currently on the market.~   "
99071|NCT01760330|"~     This project is being used to assess the utility of intravenous acetaminophen in the~     pediatric population undergoing palate repairs. This study is a prospective randomized~     double blinded placebo controlled study. The investigators will have two arms, one group of~     patients will receive intravenous acetaminophen and one group that will receive a placebo at~     a total of four doses over 24 hours. The results of this study may affect the intraoperative~     anesthetic management as well as post-operative surgical management of this specific patient~     population. The goal is to determine the benefit of adding a non-opioid analgesic and~     hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia~     care unit as well as during the post-operative stay.~   "
99072|NCT01760317|"~     The purpose of this study is to compare two different approaches (midline and parasagittal)~     during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of~     concordant pressure paresthesia occurring during the LESI in determining outcome.~      The investigators are planning to include 100 patients, undergoing LESI for radicular low~     back pain. This will be single-blinded randomized study. Every patient will receive the same~     medication we would use regardless of participating in the study. The patients will be~     randomly assigned to one of two groups, based on the approach:~        -  Group I (50 patients) - will get LESI using midline (MIL) approach.~        -  Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.~   "
99073|NCT01760304|"~     To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart~     function at rest by decreasing lung hyperinflation in patients with COPD (Chronic~     Obstructive Pulmonary Disease).~   "
99074|NCT01760291|"~     To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure~     Technology~   "
99075|NCT01760278|"~     1. Culture conditions of developing embryos are highly controlled in the Embryoscope and~          are monitored by Time-lapse videography to produce 3D images at different stages.This~          cannot be done under conventional culture conditions.~        2. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the~          Embryoscope,through latest software.~        3. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.~   "
99076|NCT01760265|"~     Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic~     disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to~     homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma~     cholesterol and triglycerides.~      As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia~     predispose to the premature development of atherosclerosis.~      However among this population there is heterogeneity in development of cardiovascular~     complications and the determinants remain unclear actually.~      The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis,~     and identify its determinants.~   "
99390|NCT01756157|"~     The primary objectives of the study are to evaluate the safety, tolerability, and efficacy~     of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by~     subcutaneous (SC) injection to prevent angioedema attacks.~   "
99077|NCT01760252|"~     The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than~     other combinations used to treat earlier stage pancreatic cancer patients with resectable~     (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma.~     For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along~     with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by~     the FDA, their combination is investigational. The purpose of this study is to evaluate the~     effects of CAPOXIRI (good and bad) on you and your cancer.~   "
99078|NCT01760239|"~     The goal of this project is to improve detection and management of elevated blood pressure~     in adolescents. It (a) uses electronic health record (EHR) technology to deliver~     patient-specific clinical decision support (CDS) to providers at the point of care, (b)~     assesses the impact of this intervention on identification and clinical care of hypertension~     in adolescents, and (c) assesses the impact of the intervention on costs of care.~   "
99079|NCT01760226|"~     The subject is invited to take part in this research study because s/he has been diagnosed~     with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or~     Post-transplant Lymphoproliferative Disorder (PTLD).~      In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists~     are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R,~     utilizes two major new strategies. First, the treatment approach utilizes continuous~     infusion of chemotherapy over four days, instead of being administered over minutes or~     hours. Secondly, the doses of some medications involved are increased or decreased based on~     how the drugs affect the subject's ability to produce blood cells, which is used as a~     measure of how rapidly the body is processing drugs.~      Using this approach in adults, researchers have shown improved cure rates in these cancers.~     Additionally, the harmful effects experienced by patients has been mild, with mucositis,~     severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing~     method has never been used in children, and the effectiveness and side effects of this new~     method are unknown in children.~      The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment~     of children with mature B-cell cancers, and to see if we can maintain cure rates (as has~     been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in~     children.~   "
99080|NCT01760213|"~     The goal of the project is to overcome some of the common barriers to treatment amongst~     recent survivors of traumatic events, by combining the world of evidence-based intervention~     with that of modern Internet technology. Specifically, it aims to test the feasibility and~     effectiveness of an Internet delivery of early-intervention trauma-focused cognitive~     behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the~     course of the study the following objectives will be achieved:~        1. The development of an Internet-based Virtual Reality intervention for preventing PTSD~          among patients who have recently experienced a traumatic event.~        2. The evaluation of the feasibility of administering this intervention, and~        3. The evaluation of the efficacy of this Internet based intervention in the prevention of~          PTSD in recent trauma survivors.~   "
99081|NCT01760200|"~     Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting~     stent (DES), but clinical results of different studies about DEB are not consistent.~      Thus, we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery~     disease (CAD).~   "
99082|NCT01760187|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and~     multiple ascending dose (MAD) study of orally administered lomitapide in healthy male~     Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to~     evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.~   "
99083|NCT01760174|"~     This study compares the effect on postoperative pain of bolus administration of ropivacaine~     in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural~     catheters following open gynecologic surgery.The study is double blind. The hypothesis is~     that the effect of the two modes of pain treatment are equal.~   "
99084|NCT01760161|"~     To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative~     pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain~     after the bilateral dual transversus abdominis plane block.~   "
99085|NCT01760148|"~     The purpose of this study is to validate the first round HCV early dynamics discovery within~     a larger population.~   "
99086|NCT01760135|"~     After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic~     aspects.~   "
99087|NCT01760122|"~     This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD,~     Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient~     evidences for the listed of the studied drug.~   "
99088|NCT01760109|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory~     and urinary tract acute bacterial infection.~   "
99089|NCT01760096|"~     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is~     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in~     patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of~     another bone marrow failure syndromes~   "
99109|NCT01759836|"~     Biochemical recurrence develops in approximately 30-40% of men with locally advanced~     prostate cancer who undergo radical prostatectomy. To date, the effect of statins on~     prostate cancer recurrence has been investigated in several retrospective studies with~     inconsistent results. The purpose of this study is to determine the impact of statin on~     biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.~   "
99110|NCT01759823|"~     The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.~   "
99165|NCT01759108|"~     Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and~     clinical studies have demonstrated an increase in saliva volume following rebamipide~     administration.We thus hypothesize that rebamipide may be efficacious in the treatment of~     dry mouth symptoms related to Sjőgren's syndrome.We will recruit SS patients in a randomized~     placebo-controlled trial for 12 weeks. The main outcome measure that will concern us is~     patient-assessed improvement of dry mouth symptoms and increase in salivary secretion Safety~     and efficacy was assessed at each visit.~   "
99090|NCT01760083|"~     CTOs are common among patients with angina, and are detected in around 20% of patients~     undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of~     PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target~     lesions is the lack of evidence-based medical data on treatment indications, and the~     continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.~      Patients with a CTO represent patients with stable coronary artery disease. The COURAGE~     trial comparing PCI with optimal medical therapy in stable coronary disease did not show a~     difference in mortality or myocardial infarction between the two treatment options. However,~     CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of~     PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether~     PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic~     burden has never been tested in a randomized controlled trial.~      While there is compelling evidence from registry studies of a clinical and prognostic~     benefit following successful PCI of CTO compared with PCI failure, there has been no~     randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal~     medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely~     related to the extent of residual ischaemia and that PCI is more effective in reducing~     residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective~     data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or~     severe (>20%) ischaemia.~      Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to~     OMT alone in improving health status at 12-month follow-up, and will be noninferior with~     respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients~     with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with~     evidence of ischemia and viability in the territory subtended by the CTO~   "
99091|NCT01760070|"~     By combining injection and dissection capability together, O-type Hybrid knife could~     possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal~     neoplasms.~   "
99092|NCT01760057|"~     The proposed study is designed to develop and test the effectiveness of a novel web-based~     HIV intervention to motivate HIV testing among men who have sex with men (MSM). The~     intervention arm includes the delivery of videos tailored to the reasons MSM have for not~     getting tested for HIV, as well as HIV testing motivational messages sent via mobile-phone~     text messaging, e-mail or instant messaging. The intervention and assessments will be guided~     by the Information-Motivation-Behavioral skills model, the Health Belief Model and the~     Stages of Change theory. The control intervention will be a health promotion message~     (similar in content to other Peruvian websites) with an invitation for free HIV testing.~     Testing will be offered at the Via Libre and Epicentro clinic, and at a mobile unit whose~     location will be determined based on participants' demand. The outcomes evaluated will be~     intention to get tested and actual HIV testing among MSM of each of the trial arms.~   "
99093|NCT01760044|"~     Investigators are conducting research about oxygen levels in the body and whether it is~     possible to use a device to measure oxygen in the body's tissues noninvasively, without~     blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to~     know how this device compares to standard measurements using blood from a catheter. This may~     help treat patients who may not be getting enough oxygen to their body.~   "
99094|NCT01760031|"~     Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney~     injury in patients undergoing elective coronary angiography. This study was designed to~     acquire long-term data of initially randomized patients in the RenPro Trial.~   "
99095|NCT01760018|"~     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely~     used, and there are many clinical trials comparing these on various aspects of anesthesia.~     However, there have not been studies comparing the quality of recovery from the different~     methods of general anesthesia. In this study, the investigators compare the functional~     recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40~     questionnaire.~   "
99096|NCT01760005|"~     The purpose of this study is to assess the safety, tolerability, biomarker and cognitive~     efficacy of gantenerumab and solanezumab in subjects who are known to have an Alzheimer's~     disease-causing mutation by determining if treatment with the study drug improves cognitive~     outcomes and disease-related biomarkers.~   "
99097|NCT01759992|"~     The global loss of muscle mass and strength associated with aging is a cause of functional~     impairment and disability, particularly in the older elderly (>80 years). Respiratory~     function can be severely compromised if there is a decrease of respiratory (RM) strength~     complicated by the presence of comorbidities and physical immobility. In this context, the~     need for supportive services involves the need for long-term care and consequently the~     institutionalization.~      Previous studies have shown that the increase of RM strength has positive healthy effects,~     such as the increase in functional capacity, the decrease in RM fatigue, the decrease of~     dyspnoea and the improvement of quality of life, both in healthy people and patients.~     Therefore, specific RM training may be regarded as a beneficial alternative to improve RM~     function, and thus prevent physical and clinical deterioration in this frail population.~      Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle~     strength and endurance, exercise capacity and quality of life in an elderly population, who~     are unable to engage in general exercise conditioning.~   "
99098|NCT01759979|"~     Very large bile duct stones are difficult to remove. The prefered method involves an~     endoscopic procedure known as endoscopic retrograde cholangiopancreatography (ERCP)performed~     using a special side viewing endoscope. In the past small baskets passed through the scope~     into the bile duct have been used to remove most stones using mechanical force.~      Recently very small scopes known as cholangioscope have been introduced through the side~     viewing endoscope directly into the bile duct. These cholangioscopes may be used to guide~     laser therapy of bile duct stones. The investigators suspect that stone destruction using~     cholangioscopy guided laser stone destruction may enable bile duct stones to be removed more~     quickly and safely when added to the mechanical techniques.~   "
99099|NCT01759966|"~     The purpose of this prospective study is to investigate denervation (ie. surgical cutting of~     autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant~     recipients. More specifically, we focus on:~        1. The physiological consequences of denervation, in particular its consequences for~          clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and~          exercise capacity. We hypothesize that denervation has negative consequences for all~          these factors.~        2. The pathological consequences of denervation and reinnervation, in particular its~          association to acute rejection and coronary artery disease (cardiac allograft~          vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection~          and development of CAV~        3. Donor and recipient factors associated with the reinnervation process. We hypothesize~          that characteristics of the surgical procedure (such as aorta cross-clamp time) as well~          as the rehabilitation process of the recipient (such as physical activity) impacts on~          the reinnervation process.~   "
99100|NCT01759953|"~     Background: Physicians´ lack of knowledge contributes to underuse of insulin and poor~     glycemic control in adults with diabetes mellitus (DM). Traditional continuing medical~     education have limited efficacy, so new approaches are required.~      Objective: We report the design of a trial to assess the educational efficacy of~     InsuOnline©, a game for education of primary care physicians (PCPs) on initiation and~     adjustment of insulin for the treatment of DM, which was designed to be: a) educationally~     adequate; and b) self-motivating and attractive.~      Methods: A multidisciplinary team, with endocrinologists, experts in medical education, and~     programmers, was assembled for design and development of InsuOnline©, a serious game which~     includes game elements and a well-defined, evidence-based curriculum of topics on insulin~     therapy. The first step of our study will be usability and playability tests, with PCPs and~     medical students, playing the game on a desktop. After that and further adjusts, we will~     perform an unblinded randomized controlled trial, with PCPs who work in the city of~     Londrina, to assess the educational validity of the game. A group of 64 PCPs will play~     InsuOnline© on the web, and the control group, of 64 PCPs, will underwent traditional~     teaching activities (lecture and group discussion). Knowledge on how to initiate and adjust~     insulin will be assessed by a web-based multiple-choice questionnaire, and attitudes~     regarding diabetes/insulin will be assessed by Diabetes Attitude Scale 3, at 3 time points:~     before, immediately after, and 6 months after the intervention. Subjects´ general~     impressions on the interventions will also be assessed by free-text questions. Software logs~     will be reviewed.~   "
99101|NCT01759940|"~     Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed~     to offer advantages over general anesthesia in terms of monitoring neurological function~     during cross-clamping of the carotid artery since, in conscious patients, speech,~     cerebration, and motor power provide early measures of inadequate cerebral perfusion. Some~     studies also claim lower shunting requirements, lower cardiovascular morbidity, and shorter~     hospital stay.~      Traditionally, the common methods of cervical plexus block are termed 'deep' or~     'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of~     identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local~     anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either~     as separate injections or as a single injection. The superficial block incorporates a~     variety of procedures. The simplest is a s.c. infiltration of local anesthetic along the~     posterior border of sternocleidomastoid muscle by either the surgeon or the anesthetist.~      An 'intermediate' block is one where the injecting needle pierces the investing fascia of~     the neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral)~     fascia. It is also possible to use a 'combined block', consisting of a deep injection and a~     superficial or intermediate injection.~      Practitioners may prefer one block to another, but no consensus exists on the efficacy of~     one block when compared with another. However, it has been suggested that complications of~     the technique are related to the deep injection and not the superficial (or intermediate)~     injection. These complications include intrathecal or intravascular injection, respiratory~     problems related to phrenic nerve paralysis, or local anaesthetic toxicity.~      In this study the Influence of the concentration of the local anesthetic ropivacaine on the~     quality of the intermediate cervical plexus block for carotid endarterectomy will be~     evaluated. For this purpose two different concentrations of ropivacaine will be compared~     (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional~     needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record~     the frequency of the most common side effects as well as the patient satisfaction with a~     standardized questionnaire.~   "
99102|NCT01759927|"~     The primary aim of this study is to investigate if and how a physical activity counselor can~     offer an added value in exercise promotion in physically inactive employees. We will explore~     if the physical activity counselor in the workplace setting can motivate sedentary employees~     to engage into systematic participation in sports and/or exercise by means of a short term~     coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching~     process.~   "
99103|NCT01759914|"~     Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid~     pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated~     IOP may eventually cause damage to the nerve of the eye and potential impairment of vision.~      The use of certain drugs has been identified as a risk factor for raised IOP, including~     various forms of administration of corticosteroids. Corticosteroids can also lead to~     cataract, which is clouding of the lens in the eye that can affect vision.~      In this research study, we would like to find out whether the use of corticosteroids in our~     dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow~     them to be more closely monitored than others. It is important to identify those patients~     who have a corticosteroid-induced pressure rise early enough to prevent them from permanent~     glaucomatous visual loss.~   "
99104|NCT01759901|"~     Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as~     Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery.~     However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to~     post-operative liver dysfunction.~      The investigators hypothesize that liver resection without the use of vascular inflow~     occlusion (Pringle maneuver) is associated with lower postoperative complications rate.~      The aim of this study is to evaluate whether elective open liver resection without vascular~     inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical~     complications in patient with hepatocellular carcinoma.~      Eligible patients undergoing liver resection in the Prince of Wales Hospital will be~     recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.~   "
99105|NCT01759888|"~     The primary objective of this protocol is to access the utility of 18F-DTBZ PET imaging as~     an in vivo biomarker to monitor neurodegeneration of both PD mouse models and PD patients.~     Secondary, the investigators will analyze progression rate of genetic-proving PARK8 and~     PARK6 patients who have homogeneous phenotype and genotype by 18F-DTBZ PET imaging.~   "
99106|NCT01759875|"~     The goal of this study is to evaluate the ability of a natural supplement (betaine~     hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The~     investigators predict that betaine hydrochloride will increase the absorption of atazanavir~     in volunteers pre-treated with proton-pump inhibitors (PPIs).~   "
99107|NCT01759862|"~     The aim of this study is to evaluate whether peri-transplant administration of a drug named~     aminophylline to children undergoing a kidney transplant from deceased donors improves early~     graft function and also projects on long term graft function.~   "
99108|NCT01759849|"~     To examine the effect of blocking signaling through the β-chain on viability, activation and~     differentiation of eosinophils and their progenitors collected from sputum, blood and bone~     marrow samples collected pre and post-allergen challenge from mild atopic asthmatic~     subjects.~   "
99166|NCT01759095|"~     The purpose of this study is to determine the benefit of patients using a multidrug blister~     packs after discharged from an university hospital to their homes.~   "
99111|NCT01759810|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of glioblastoma multiforme (GBM) involves allogeneic haploidentical~     hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic lymphocytes (CTLs).~      TCs and TSCs are isolated from GBM sample. Dendritic cells are isolated from peripheral~     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to~     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are~     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)~     administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort~     demonstrating efficiency continues the therapy, while cohort demonstrating no efficiency is~     transferred to active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to~     targeted regulation of therapeutic cell systems with specific properties, are detected in~     TSCs using complete transcriptome profiling of gene expression, proteome mapping and~     profiling of proteins, bioinformation and mathematical analysis and mathematical modeling of~     protein profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs~     regulation are detected, as well as protein ligands able to regulate reproductive and~     proliferative properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-modified HSCs.~      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line~     therapy.~   "
99112|NCT01759797|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival~     by several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
99113|NCT01759784|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival~     by several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
99114|NCT01759771|"~     Vitamin D promotes the differentiation of prostate cancer cells and maintains the~     differentiated phenotype of prostate epithelial cells. The results of the investigators'~     clinical studies indicate that vitamin D3 supplementation results in a decrease of positive~     cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators~     hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at~     4000 international units per day (intervention group) will show an improvement in the number~     of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of~     undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran~     subjects taking placebo (control group).~   "
99115|NCT01759758|"~     The investigators are conducting a randomized clinical trial comparing two types of splints~     for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet~     inclusion criteria will be randomized to either Group A or B. Group A will be treated with~     the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded~     thermoplastic hand-based splint. The thermoplastic splint will provide support of the~     metacarpal but does not immobilize the patient's wrist or interphalangeal joints.~      Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made~     thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated~     better than the other and will the compliance be different between the two groups?~   "
99116|NCT01759745|"~     Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions~     of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and~     situation specific modulations of their symptoms. So called sensory tricks are actions~     that minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing~     air, and applying pressure to the periocular or temple region. (Weiner 1984) Many patients~     describe that other tasks/situations are exacerbate their symptoms specifically under bright~     fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns~     differ between BEB patients and control during rest, reading and talking.~      In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze~     shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects~     emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988)~     However, little is known about various task and emotion specific influences on symptoms of~     BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car).~      Differences in emotion and gaze related blink patterns between patients and controls will~     contribute to the understanding of the pathophysiology of BEB. This might offer new~     therapeutic options, e.g. symptom modulation.~      The investigators hypothesize that blink patterns, measured by duration and frequency of~     pupillary occlusion differ between patients and control, when performing gaze shifts and~     emotion related blink patterns, measured by duration and frequency of pupillary occlusion~     differ between patients and controls.~      The aim of this pilot trial is to assess differences in gaze evoked and emotion related~     blink patterns between patients and controls. These differences might contribute to the~     understanding of the pathophysiology of BEB.~   "
99117|NCT01759732|"~     Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body~     irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting~     of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion~     of CD3 cells may contribute to prevent developing severe acute graft versus host disease~     (GVHD) in haploidentical transplantation.~      Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell~     transplantation with fixed dose of T cells after in vitro T cell depletion using CD3~     monoclonal antibody for children with acquired severe aplastic anemia~   "
99118|NCT01759719|"~     Recent reports have described cases of novel thin-strut coronary stent longitudinal~     deformation during or after deployment and a biomechanical analysis have suggested increased~     susceptibility for such a complication for the platinum chromium (PtCr) coronary stent~     platforms . This analysis aims to assess the incidence of longitudinal stent deformation for~     PtCr stents in a large single centre all-comers population using quantitative angiographic~     analysis (QCA).~   "
99119|NCT01759706|"~     The purpose of this study is to assess the adherence to an enhanced recovery after surgery~     (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in~     patients undergoing pancreaticoduodenectomy (PD).~   "
99121|NCT01759680|"~     Tiredness, lack of motivation and low compliance can be observed in nursing home residents~     during the practice of physical activity. Because exercises should not be too vigorous,~     whole body vibration could potentially be an effective alternative.~      The objective of this randomized controlled trial is to assess the impact of 3-month~     training by whole body vibration on the risk of falls among nursing home residents.~      Patients were randomized into two groups: the whole body vibration group which received 3~     training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz~     intensity and a control group with normal daily life for the whole study period.~      The impact of this training on the risk of falls was assessed blindly by three tests: the~     Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk~     performed with a tri-axial accelerometer.~   "
99122|NCT01759667|"~     Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in~     obese patients. This loss is a result of several factors that go beyond the simple~     anatomical abnormality of the gastrointestinal tract and may be the product of post-op~     energy expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis~     (DIT) are important components of energy expenditure and possible changes in them can~     perform an important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously,~     we conducted a cross-sectional study where we measured the RQ and DIT in pre and post-op~     RYGB patients, which was published in the Surgery of Obesity and Related Diseases (SOARD)~     journal. The objective of this study is to perform a prospective analysis of these same~     variables (RQ and DIT), evaluating them in the same patients, when pre and postoperatively.~   "
99123|NCT01759654|"~     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and~     elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by~     intramuscular injection into the upper arm. Safety outcomes included immediate reactions at~     the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited~     adverse events for 28 days, and serious adverse events. Sera prepared from blood samples~     will be collected from each subject immediately prior to, and 28 days after vaccination.~     Anti-hemagglutinin (HA) antibody titers will be determined using the WHO hemagglutination~     inhibition reference technique. The central laboratory who is responsible for antibody~     titrations will not be aware of the background of blood samples (e.g., pre- or post-serum),~     it is also called observer-blinded. All participates will be followed, either by clinical~     visit or by telephone contact, for 8 weeks after the vaccination for safety reasons.~   "
99124|NCT01759641|"~     The aim of the present work was to analyze the short-term variability of SO2 during~     hemodialysis in sessions with and without hypotension to correlate the SO2 variability to~     hemodynamic instability.~   "
99125|NCT01759628|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver~     function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and~     anthropometric measurements (body mass index and waist circumference)in subjects with~     non-alcoholic fatty liver disease.~   "
99126|NCT01759615|"~     This research is being conducted in preterm newborns with 'in utero' growth restriction due~     to inadequate blood flow from the mother to the baby. These deprived babies adapt to the not~     so conducive uterine environment by certain adjustments in blood supply to internal organs~     thereby permitting as best as possible blood flow to brain heart etc., which are the vital~     organs and whose adequate functioning is required for survival. In this bargain the gut~     (intestines) gets poor blood supply and hence its appropriate functioning is jeopardized. In~     the past such babies (after birth) were not fed for days together which compromised their~     growth even further. Premature growth restricted' babies are at increased risk of further~     growth faltering if not fed in time as also to a condition called 'Necrotising~     enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal~     distension, blood in stools and inability to feed for much longer duration thereby further~     affecting growth. This study is evaluating a feeding schedule of early versus late~     initiation of feeding to arrive at the best time to feed such doubly jeopardized premature~     growth restricted babies to avert the above mentioned consequences.~      No study has been conducted in India to confirm the aforementioned fact and hence this study~     has been planned. The information learned from this study will help us to feed these small~     premature as well as growth restricted babies with AREDF better which will go a long way in~     the care of such preterm growth restricted newborns.~   "
99127|NCT01759602|"~     The overall objective is to evaluate the tolerability/safety and preliminary efficacy of~     CINRYZE® (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic~     neuritis and/or transverse myelitis in NMO and NMOSD.~      Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units~     intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.~      Secondary Objectives:~        -  To determine the frequency of adverse events with CINRYZE in this patient population.~        -  To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status~          Scale and Low Contrast Visual Acuity).~        -  To compare the change in MRI lesion size and extent following a course of CINRYZE.~   "
99128|NCT01759589|"~     To compare the effectiveness of three different anesthetic regimens (propofol,~     remifentanil-propofol and sevoflurane in ECT.~   "
99129|NCT01759576|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin~     (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal~     kidney function and non-diabetic volunteers with varying degrees of kidney impairment~     (including volunteers with end-stage renal disease requiring hemodialysis).~   "
99130|NCT01759563|"~     Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide~     targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to~     obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without~     delaying the procedure of valve implantation.~   "
99178|NCT01758939|"~     Retrospective prospective cohort study aimed at Assessing the predictors to the response to~     the antiviral combined therapy with pegylated Interferon (Both types: Alfa 2 A and Alfa 2 B)~     in hepatitis C virus infected Egyptian patients.~   "
99179|NCT01758926|"~     The study aims to:~        1. To determine the relationship between inflammatory activities and epithelial gaps in~          IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.~        2. To demonstrated the alteration of local barrier function in IBD using CLE.~   "
99131|NCT01759550|"~     The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol~     Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and~     gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic~     value of using LigaSure in gastric surgeries will be appraised.~      In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or~     gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis~     controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All~     subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or~     placation) procedure at Durham Regional Hospital will be recruited.~      Data Analysis will be performed using the data collected in the software program titled~     MetaBar at Duke University Medical Center. Categorical variables will be summarized as~     proportions for each category; continuous measures will be summarized by mean and standard~     deviation or median and range as appropriated for the data distribution. Procedure-related~     risks are those typically associated with gastric procedures and general anesthesia~     including intra-operative bleeding, infection, and injury to surrounding organs and~     structures. Device related risks include those normally associated with the use of~     electrosurgery including intra-operative bleeding, unintended tissue burns, electrical~     shock, and electrical stimulation of muscles and nerves.~   "
99132|NCT01759537|"~     The purpose of this study is to test two standard of care techniques of placing dental~     implants, and to compare how people's bones and gums respond to two different depths at~     which implants are placed.~   "
99133|NCT01759524|"~     Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is~     predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone~     produces analgesia. When administered centrally its effects are predominantly due to its~     alpha 2 activity. When administered peripherally it prolongs the analgesia through its~     vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another~     possibility is that it prolongs analgesia of peripheral nerve blocks due to a~     hyperpolarisation current .Clonidine has been used successfully both for upper and lower~     limb blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A~     major concern with the lower limb blocks is the risk of falls associated with prolonged~     motor blockade during early mobilisation. Clonidine has been shown to intensify and prolong~     the motor blockade produced by long acting local anaesthetics. Lidocaine when used in~     combination with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses~     of clonidine are associated with longer analgesia but with more side effects. Clonidine in a~     dose of 90 mcg administered with local anaesthetics can produce analgesia for up to 10 hrs~     with minimal side effects. The aim of this study is to compare lidocaine 2% + clonidine~     1.5mcg/kg with bupivacaine alone in terms of block selectivity for combined sciatic~     -saphenous nerve block in patients under going semi elective foot/ankle procedures.~   "
99134|NCT01759511|"~     This study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in~     participants with Idiopathic Pulmonary Fibrosis (IPF) who had previously participated in~     Gilead clinical trial AB0024-201.~   "
99135|NCT01759498|"~     Since hydrogen therapy in humans seems to be beneficial for treating inflammation,~     ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects~     of exogenously administered hydrogen as an element of instant management of sport-related~     soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main~     aim of the present study will be to examine the effects of two-week hydrogen-rich oral and~     topical administration on the inflammation, recovery and functional abilities in competitive~     male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from~     February to June) subjects (36 professional athletes) will be recruited and examined by~     certified sports medicine specialist in the out-patient clinics of the Center for Health,~     Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury~     was sustained. The subjects will be allocated to a double-blind design to three randomly~     assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will~     receive traditional treatment protocol after the soft-tissue injury, consisting of RICE~     protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first~     experimental group will follow the above procedures with additional administration of oral~     hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in~     the second experimental group will follow the procedures of first experimental group with~     additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout~     the study. Participants will be evaluated at the beginning of the study (e.g. at the time of~     the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive~     protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and~     walking, c) degree of joint swelling, d) passive joint flexibility, and, e) subjective~     side-effects. The investigators expect that the administration of hydrogen will~     significantly improve inflammation outcomes (e.g. decrease in serum C-reactive protein) as~     compared to the placebo, with topical hydrogen administration will additionally improve~     post-injury recovery outcomes (e.g. pain intensity, degree of swelling). These results could~     support the hypothesis that hydrogen-rich intervention may be included as an element of~     immediate treatment for sport-related soft tissue injuries.~   "
99136|NCT01759485|"~     Background: Despite improvements in medications, treatment delivery and rehabilitation,~     schizophrenia outcomes remain suboptimal. There are a proportion of 30-40%~     treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin~     D is a neuro-active steroid that acts on brain development, leading to alterations in brain~     neurochemistry and adult brain function. Early deficiencies have been linked with~     neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been~     associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease,~     depression and cognitive decline. Ecological studies support a potential role for vitamin D~     in schizophrenia. These data include studies that have explored the association between~     schizophrenia and winter/spring birth and also the apparent increased incidence and~     prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of~     vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia~     patients, and the relation of disease severity to serum vitamin D levels. Methods: the~     investigators will use a prospective, interventional, longitudinal, double blinded,~     placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated~     chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly~     assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or~     oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical~     severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive~     (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will~     be supplemented with vitamin D after the 8 weeks period, and then will be assessed again~     with the same protocol of vitamin D treated patients. All participants will be assessed~     again after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way~     ANOVA with repeated measures for comparison of vitamin D and control groups. The~     investigators will apply intention to treat and LOCF.~   "
99137|NCT01759472|"~     To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of~     anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in~     a specific sensitive to leukotriene population of asthma.~      Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in~     leukotriene-sensitive group than leukotriene-insensitive group.~   "
99181|NCT01758900|"~     Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small~     intestine.Initial reports indicated that CO2 was effective during the colonoscopy~     ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy)~     examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.~   "
99138|NCT01759459|"~     The purpose of this study is to compare the pain level felt by patients when receiving~     placement of a peripheral intravenous catheter (IV line) following the administration of a~     local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and~     bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the~     pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine~     itself may cause pain upon administration. To help counter this discomfort, pharmacies can~     buffer the lidocaine using sodium bicarbonate, which increases the pH to a neutral value,~     resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia~     with peripheral IV placement, particularly in patients with a lidocaine allergy, as it~     contains benzyl alcohol which acts as a local anesthetic.~      There are minimal reports from the literature that directly compare patient reported pain of~     all three agents to one another, although studies do exist that have compared buffered~     lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To~     address this comparison gap, the following research questions need to be asked: which~     anesthetic agent is the superior premedication for reducing the amount of pain upon~     administration of the local anesthetic itself and for the pain associated with the~     peripheral insertion of the catheter? The hypothesis of the investigators is that there is~     not a significant difference in the degree of pain scales between the anesthetic agents to~     justify the pharmacoeconomic costs associated with compounding buffered lidocaine.~      The primary outcome measured in this study will be the level of pain reported by the patient~     upon administration of the local anesthetic and upon insertion of the peripheral intravenous~     catheter. A secondary outcome includes a pharmacoeconomic analysis that will look~     specifically at the cost-savings of using one agent over the other and will take into~     account the daily time allocated to pharmacy technicians and pharmacists for compounding and~     verifying buffered lidocaine.~   "
99139|NCT01759446|"~     To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and~     acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when~     crushed and administered intranasally to non dependent, recreational opioid users.~   "
99140|NCT01759433|"~     The reference intervals for Sonoclot Analysis may be different between Chinese and American.~     So far, no reference interval has been established in Chinese for Sonoclot Analysis. This~     study is going to establish the first Chinese reference intervals for Sonoclot Analysis and~     test whether they are different from American reference intervals.~   "
99141|NCT01759420|"~     The purpose of this study is to assess the use of the medication ondansetron (zofran) in the~     emergency department. There are studies of the ability of ondansetron to cause a~     prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer~     patients, but not on emergency department patients. This is an observational study where~     patients that are going to receive the anti-nausea medicine ondansetron in the emergency~     department will have an EKG performed every 2 minutes for 20 minutes to determine if the QT~     interval prolongs and returns to normal in that time period. Any serious outcomes will be~     reported. There is expected to be no adverse outcomes from this routinely used medication.~   "
99142|NCT01759407|"~     The purpose of this study is to prospectively compare post-operative pain relief in~     pediatric patients undergoing traumatic femur fracture repair who have received either a~     femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic~     for analgesia.~   "
99143|NCT01759394|"~     A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the~     Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation~     Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount~     of free base) to healthy subjects Receiving a low-fat Meal.~   "
99144|NCT01759381|"~     The purpose of this study is to evaluate the outcome of incisional negative pressure wound~     therapy in preventing surgical site infections and wound complications (dehiscence) in~     high-risk patients undergoing complex spinal surgery.~   "
99145|NCT01759368|"~     In the study benefits of using mobile phone assisted remote patient monitoring including~     self-measurements of blood pressure, heart rate and weight as well as monitoring of personal~     health status are investigated in the care of heart failure patients.~   "
99146|NCT01759355|"~     This is a two arm, single center feasibility study of 20 patients with non-metastatic~     cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals.~     Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after~     treatment.~   "
99147|NCT01759342|"~     This protocol was designed to assess if when subjects with CF are admitted to the hospital~     for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity~     aerobic, resistance, flexibility and balance exercises) was superior to our usual care~     intervention (30 min/day of self selected mode and intensity of exercise) in improving~     aerobic capacity, muscle strength/power, flexibility and balance.~   "
99148|NCT01759329|"~     Epidemiological studies have indicated a positive health impact of coffee. Nevertheless,~     intervention studies testing the effect of daily coffee consumption over a longer period are~     lacking so far. Moreover, there is a lack of knowledge about the properties of different~     coffees and their influence on weight development. Therefore, we tested the effect of two~     coffees differing in their alkyl pyridine content over a period of 3 months on weight~     development.~   "
99149|NCT01759316|"~     Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory~     distress and lung injury caused by mechanical ventilation.~   "
99150|NCT01759303|"~     The purpose of this study is to determine the 4-month Progression-Free Survival (PFS), with~     demonstrated increase in tumor doubling time, of eligible subjects treated with pazopanib~     according to RECIST version 1.1 guidelines.~   "
99151|NCT01759290|"~     ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:~        -  Provide ongoing post-market surveillance for documentation of safety, performance and~          clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily~          percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU,~          on-label use).~        -  To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or~          overlapping use (bailout, optimization of long lesion treatment) for the treatment of~          patients with ischemic heart disease caused by de novo native coronary artery lesion(s)~        -  Collect additional information (e.g. acute success) to evaluate handling and~          implantation of Absorb BVS by physicians under a wide range of commercial use~          conditions and following routine clinical practice.~   "
99180|NCT01758913|"~     Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been~     used for years. Previous studies indicated that ibuprofen has similar effect on ductal~     closure as indomethacin but has less adverse effects on renal function, cerebral blood flow~     and mesenteric blood flow.1-7 There are, however, very few studies being done specifically~     on extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature~     kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We~     hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be~     different between indomethacin and ibuprofen.~   "
99152|NCT01759277|"~     Patients typically experience moderate-to-severe pain following knee arthroplasty that is~     usually treated with a combination of oral and intravenous analgesics and enhanced by~     continuous peripheral nerve blocks. There are currently two locations to place a perineural~     catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an~     adductor canal catheter. Both have been demonstrated to be effective following knee~     arthroplasty. However, it remains unknown if one location is superior to the other; or, more~     accurately, what the relative benefits are to each technique.~      While femoral CPNB has many benefits, one of the challenges of using this technique is that~     there is a decrease in quadriceps muscle strength which can be a limiting factor for~     rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis.~     This block may lessen block-induced quadriceps weakness following knee arthroplasty compared~     with a femoral infusion.~      The investigators hypothesize that compared with femoral perineural local anesthetic~     infusion, an adductor canal infusion is associated with a shorter time until four discharge~     criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3)~     ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting~     position without another's assistance.~   "
99153|NCT01759264|"~     The objective of this observational study was to assess changes in fecal calprotectin levels~     and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's~     Disease who were treated with adalimumab.~   "
99154|NCT01759251|"~     The purposes of this international post-marketing observational program is to investigate~     effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of~     vestibular vertigo after treatment discontinuation in population of Russia and Ukraine~     outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory~     analyses of results from both participating countries may be expected to provide insights~     about the subjective circumstances of vestibular vertigo patients in a wider than usual~     range of gender, underlying ICD-10 diagnosis, national and cultural situations.~   "
99155|NCT01759238|"~     This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in~     oligometastatic patients neither being progressive nor resectable after chemotherapy.~   "
99156|NCT01759225|"~     A computerized registry of cardiovascular disease patients in a large health maintenance~     organization in Israel. The registry is aimed to be used by health professionals to identify~     cardiovascular disease patients and to follow the courses of their illnesses and risk~     factors.~   "
99157|NCT01759212|"~     The aim of the study is to investigate safety and efficacy of intramyocardial implantation~     of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy~     undergoing left ventricular assist device implantation.~   "
99158|NCT01759199|"~     The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker~     of exercise tolerance evolution during a pulmonary rehabilitation program in people with all~     stages of severity of Chronic Obstructive Pulmonary Disease (COPD).~   "
99159|NCT01759186|"~     The investigators will study the biologic and chemical differences that cause the greater~     incidence, and severity of asthma in women as compared to men. Severe asthma affects boys~     more than girls, while severe asthma in adults is predominantly a disease of women. The~     investigators aim to identify the processes that occur in the body that are behind the onset~     of severe asthma in young women during the teenage years, and the resolution of severe~     asthma in boys. To further evaluate gender influences on asthma, asthmatic women at~     different stages of their menstrual cycle (period) will be also studied. The investigators~     aim to use biomarkers to develop testing procedures that will identify different types or~     characteristics of asthma in men and women; and to follow patients over time to uncover~     relevant clinical outcomes of biomarkers. The investigators anticipate that they will 1)~     develop clinically relevant tests to identify unique types or characteristics of asthma and~     severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and~     3) identify the reasons for why adult women are affected more than men with severe asthma.~   "
99160|NCT01759173|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide~     both a noninvasive and portable measure of brain function. The ERPs provide excellent~     temporal information, but spatial resolution for ERPs has traditionally been limited.~     However, by using high-density electroencephalograph (EEG) recording spatial resolution for~     ERPs is improved significantly. The paradigm for the current study will combine~     neurophysiological knowledge with mathematical signal processing and pattern recognition~     methods (BNA™) to temporally and spatially map brain function, connectivity and~     synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~   "
99161|NCT01759160|"~     To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider~     plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with~     much more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean~     arterial pressure, systemic vascular resistance , central venous return or stroke volume~     would be observed.~   "
99162|NCT01759147|"~     There are many surgical methods available for the treatment of patients with~     acromioclavicular dislocations. No single method has yet proven to be superior to the~     others.~      The purpose of this study is to evaluate the clinical outcome and complications associated~     with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a~     single transclavicle transcoracoid bone tunnel. The implantation is performed using an~     endobutton system that augments the repair with fibrewires.~      The investigators will prospecitvely follow 30 patients enrolled in the study.~      The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will~     result in good clinical outcome and few complications.~   "
99163|NCT01759134|"~     The objective of this study is to compare the post-discharge growth of preterm infants fed~     with 2 different post discharge formulas.~   "
100236|NCT01745094|"~     The purpose of this study is to evaluate the safety and efficacy of concomitant use of~     mirabegron in patients with overactive bladder under treatment with solifenacin.~   "
99167|NCT01759082|"~     Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with~     moving erythrocytes to visualize perfusion in the microcirculatory system.~      The new device to be used in this study have been adapted specifically for the application,~     facilitating its use in clinic. It has been designed to take a standard white light image of~     the area under inspection simultaneously with the perfusion image to facilitate clinical~     assessment.~      Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin~     found in approximately 0.3% of children. They are commonly found on the face and neck and~     may cause serious psychological consequences.~      Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is~     very effective in PWS in closing the blood vessels and diminishing therefore the redness of~     the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.~      Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical~     inspection and digital photography.~      By measuring the activity and intensity of the microcirculation present in and under the~     skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser~     (PDL) treatment for port-wine stains.~   "
99168|NCT01759069|"~     An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The~     overall success rate for this treatment is high; 97% of the treated teeth are retained in~     the oral cavity after 8 years (Salehrabi & Rotstein, 2004). However, there are teeth that~     have a persistent granuloma because of various reasons and need endodontic retreatment or~     apical surgery. Overall results in literature for an endodontic retreatment show a success~     rate of 77%-89% (Ng, Mann, & Gulabivala, 2008; Salehrabi & Rotstein, 2010), the results of~     apical surgery are more or less similar (von Arx, 2005). Which of the two methods is~     preferred for failed root canal treatments is dependant on a variety of reasons. (For~     example an amount of gutta-percha outside the apex of the root is better corrected by apical~     surgery. Persistent infection as a result of insufficient gutta-percha amounts in a treated~     root is best treated with an endodontic retreatment.) The overall results in apical surgery~     have increased the past years due to better preparation of the apical end of the root by the~     use of an ultrasonic device (de Lange, Putters, Baas, & van Ingen, 2007) and new materials~     that are used for filling of the rootend e.g. MTA (von Arx, Hanni, & Jensen, 2010)~      Objective of the study:~      The objective of this study is to assess whether or not apical surgery that is carried out~     with the help of a microscope has a higher success rate than apical surgery without the use~     of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi,~     & Weinstein, 2009).~   "
99169|NCT01759056|"~     The purpose of this study is to evaluate the safety and tolerability as well as the~     pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with~     active ulcerative colitis.~   "
99170|NCT01759043|"~     The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using~     a single guiding catheter for left and right coronary angiography and intervention in~     patients with ST elevation myocardial infarction (STEMI) can reduce procedure time,~     fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional~     approach which first underwent coronary angiography with diagnostic catheter followed by~     guiding catheter selection for intervention.~   "
99171|NCT01759030|"~     The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is~     equivalent to MabThera when used in combination with methotrexate for the treatment of~     patient with rheumatoid arthritis~   "
99172|NCT01759017|"~     The costs and potential complications (side effects) of therapies currently used to treat~     Crohn's disease could be reduced if a non-invasive test existed that determined which~     therapies benefit patients and which do not. A non-invasive test is a test that does not~     involve cutting or entering the skin. Currently, once therapies are prescribed, doctors rely~     solely on clinical parameters to gauge whether the therapies are helpful. This includes~     evaluation of overall general well-being, abdominal pain, and number of liquid stools per~     day. There is no established and reliable non-invasive test that can predict whether a~     person is responding to therapy early in the course of treatment when these evaluations may~     be inconclusive.~      During this research study we will look for changes in sugar metabolism on low-dose PET/CT~     before and 2 weeks after the first infusion of infliximab therapy. This is to find out if~     these changes can predict clinical response and steroid-free remission at two, six and 12~     months, in patients with Crohn's disease.~   "
99173|NCT01759004|"~     The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is~     a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle~     strength between women with lipedema and women with obesity. The secondary aim is to~     investigate whether there is a difference in physical fitness between women with lipedema~     and women with obesity.~   "
99174|NCT01758991|"~     In the acute phase of stroke, dysphagia (difficulty/inability to swallow) is a common~     problem that can have serious consequences such as aspiration pneumonia, increased lenght of~     hospitalisation, and death. It would be interesting to enhance the therapeutic effect of~     swallowing retraining by means on non-invasive brain stimulation such as transcranial direct~     current stimulation (tDCS).~      Hypothesis: during the acute phase of stroke, applying tDCS over the brain during the~     revalidation and/or supervised feeding improves dysphagia significantly when compared to~     sham tDCS.~   "
99175|NCT01758978|"~     The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone~     bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release~     tablet.~   "
99176|NCT01758965|"~     The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment~     to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors~   "
99177|NCT01758952|"~     Stroke is an important cause of perioperative morbidity and mortality, particularly in~     patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to~     be high (2.2-5.2%). However, little is known regarding perioperative stroke following other~     types of surgery including general, urological, orthopedic, thoracic and gynecological~     procedures. We therefore propose to undertake a multicenter, observational cohort study, to~     determine the current incidence of, the risk factors for, and outcome associated with~     perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.~   "
101674|NCT01726257|"~     The objective of this study is to assess the safety and effectiveness of the Endologix~     Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).~   "
99182|NCT01758887|"~     -  Would be there any difference in dopamine synthesis between remitted clinical high risk~          subjects for psychosis and healthy control?~        -  What would happen to dopamine synthesis after antipsychotic discontinuation in clinical~          high risk subjects for psychosis?~        -  What about the dopamine synthesis in recurred clinical high risk subjects for psychosis~          after the discontinuation?~   "
99183|NCT01758874|"~     PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The~     investigators hypothesize that reducing blood viscosity (through controlled phlebotomy),~     thereby increasing the deformability of red blood cells, should reduce the flow resistance~     and improve tissue perfusion leading to improved clinical function and a reduction in~     symptoms.~      Preliminary data demonstrates that phlebotomy causes a measurable change in blood viscosity~     as measured by the home-made rheologic method.~      To evaluate the effectiveness of changes in blood viscosity, obtained through controlled~     phlebotomy, as a therapy to improve functional status associated with atherosclerotic~     ischemic limbs in pre-amputation patients.~   "
99184|NCT01758861|"~     Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary~     bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection~     against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the~     present study was to investigate the effect of a single preoperative bolus of EPO on the~     incidence of AKI following complex valvular heart surgery in a randomized, controlled and~     double-blind trial.~   "
99185|NCT01758848|"~     Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge~     incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age.~     The elderly is increasing with time, so the people who suffering from overactive bladder is~     also increasing. Research related to overactive bladder in the field of physical therapy is~     remained needed. The purposes of this study are to investigate the application of physical~     therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle~     contraction for urgency inhibition, including the urodynamic study and clinical study.~      There are three stages in this study. In the first stage, we are going to develop a specific~     health-related quality of life questionnaire for urinary incontinence in Taiwan version. One~     hundred and fifty women with urinary incontinence and fifty healthy women without lower~     urinary tract symptom will be recruited in the first year to investigate the reliability and~     validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold~     standard for validity. Fifty women with urgency will be recruited in the second stage to~     test the effect of muscle active contraction strategies to inhibit detrusor pressure and~     urgency. The three muscle active contraction strategies include pelvic floor muscle strong~     contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic~     contraction. The outcome variables including detrusor pressure of the urodynamic parameter~     and self-reported urgency score. Simultaneous image record by abdominal ultrasound during~     the urodynamic examination will be used to ensure the accuracy of muscle action. The~     predictors of success of strategy from the result of the second year will be used to~     stratify the patients in the third stage. Eighty women with urgency will be recruited in the~     final stage to examine the clinical effect of strategy for urgency inhibition.~   "
99186|NCT01758835|"~     PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress~     negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable~     splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks~     and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections.~     Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in~     follow up-visits 6 and 12 weeks and 1 and 2 year.~   "
99187|NCT01758822|"~     The purpose of this study is to evaluate the role of endotracheal suction on the occurrence~     of meconium aspiration syndrome in depressed meconium stained babies. Meconium aspiration~     syndrome (MAS) is believed to result from aspiration of meconium and consequent chemical~     pneumonitis. Meconium can be aspirated into the lungs in the womb as well. Meconium in the~     distal airways is not accessible to endotracheal (ET) suction which clears only the~     windpipe. Furthermore there is growing evidence in support of asphyxia-hypoxia-acidosis in~     the causation of lung disease. Moreover, in the absence of a clear role of ET suction in~     depressed meconium stained newborns, critical time could be lost in assessment, intubation~     and ET suction (range: 30 seconds to 1 min) which might delay the definitive step of~     ventilation for resuscitation of such babies that can potentially affect the outcome~     adversely.The utility or futility of endotracheal suction in preventing MAS in depressed~     meconium stained neonates has not been systematically studied and there is inadequate~     information in literature in favor or against this practice.Thus this study is an attempt to~     evaluate the effect of endotracheal suction on the occurrence of MAS in depressed full term~     neonates born through meconium stained amniotic fluid (MSAF).~   "
99188|NCT01758809|"~     The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is~     a better alternative pain control modality than the conventional intravenous patient~     controlled analgesia.~   "
99189|NCT01758796|"~     The purpose of the study is to find the optimal treatment for ER-Stress positive Weber-B~     unimallaolar ankle fractures.~   "
99190|NCT01758783|"~     Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral~     nutrition support on nutritional status, immunologic function and intestinal permeability of~     patients with chronic radiation intestinal injury.~      Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group~     and glutamine-enriched TPN group. The patients were administered total parenteral nutrition~     for at least four weeks (two weeks pre-operation and two weeks post-operation). The~     nutritional status, immunologic function, plasma concentration of glutamine and intestinal~     permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2~     weeks post-operation. Nutrition status was determined the plasma concentrations of~     hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were~     measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to~     CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal~     permeability was detected by the urinal ratio of lactulose and mannitol.~   "
99191|NCT01758770|"~     1. To determine the prevalences of osteoporotic fracture in elderly Chinese population.~        2. To determine the prevalences of osteoporosis in elderly Chinese population using QCT~          BMD measurement.~        3. To investigate the difference in the prevalences of osteoporosis between cities and~          urban-rural area in China.~        4. To investigate the association of body composition with osteoporosis~        5. To investigate the prevalence of liver steatosis in China~        6. To investigate the application of QCT fat measurement~   "
99192|NCT01758757|"~     Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with~     conventional 20, 23, and 25-gauge vitrectomy were compared.~   "
99193|NCT01758744|"~     An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®)~     in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive~     Pulmonary Disease (COPD)~   "
99194|NCT01758731|"~     This is a research study that plans to learn more about the safety and tolerability of an~     investigational drug called Olaparib, in combination with radiation therapy and cetuximab.~      Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a~     feasible, biologically-based alternative to standard chemoradiation, with acceptable~     toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year~     smoking history.~   "
99195|NCT01758718|"~     Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale~     of superficial punctate keratopathy and score of wearing glasses to correct refractive~     errors were measured.~   "
99196|NCT01758705|"~     The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the~     HRQoL, work productivity and activity impairment in patients with psoriasis using~     adalimumab.~   "
99197|NCT01758692|"~     People with a spinal cord injury (SCI) have limited ability to move and feel sensation below~     the level of the SCI. Doctors and researchers have tests which determine the level of~     function and sensation, this test was developed by the American Spinal Cord Injury~     Association (ASIA) and has been modified over the years to improve use and sensitivity. Most~     recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test~     does not include the evaluation of autonomic nervous system (ANS) impairment. However,~     people with SCI do have impairment of the ANS and this may adversely affect how organ~     systems in the body function. Specifically, ANS impairment tends to result in changes in~     heart rate and blood pressure that may relate to the level of the SCI, but this is not fully~     understood. In this investigation we hope to develop simple tests which will allow doctors~     and scientist the ability to measure the amount of ANS impairment to the cardiovascular~     system, specifically the heart. The first part of the study will be to determine the heart~     rate response to several tests (administration of drugs and physical challenges) which will~     change heart rate. These tests will be given to people with and without SCI and the heart~     rate response will be compared between people with and without SCI. The bigger the~     difference in the heart rate response to these test between people with and without SCI the~     greater degree of ANS impairment in the people with SCI. Once this heart rate difference is~     determined, several simple tests (deep breathing, saliva test, Valsalva) will be performed~     in people with and without SCI to again compare the heart rate response. The second part of~     this study will be to determine if the heart rate responses to the first set of tests~     (administration of drugs and physical challenges) can predict the heart rate response to~     these simple tests (deep breathing, saliva test, Valsalva). The aim of this study is to~     develop a simple battery of tests which can be easily used by doctors and scientists to~     determine the degree of ANS impairment to the heart in persons with SCI.~   "
99198|NCT01758679|"~     This clinical trial is designed to provide one kind of modalities for preventing the~     recurrence and metastasis of PLC. If the expected therapeutic efficacy is achieved, it shall~     contribute actively to boosting the therapeutic level of PLC, prolonging its recurrent time~     and enhancing its overall survival. And it may also raise the clinical recognition of this~     technology, promote its clinical applications and generate excellent social reputations and~     economic returns.~   "
99199|NCT01758666|"~     At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so~     on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX,~     the survival rate can reach about 60%, so the HD-MTX is the most important component in~     patients of osteosarcoma.~      Studies have shown that, MTX efficacy and adverse reactions were associated with blood~     concentration level and duration, selecting the right time and dose to give CF is the~     critical point.~   "
99200|NCT01758653|"~     The purpose of this biorepository is to collect blood from patients at the time of CO~     poisoning and at follow-up visits months to years later. These samples can be used in the~     future to learn more about how CO damages the heart and brain and whether blood tests could~     predict which patients will have problems after CO poisoning.~   "
99201|NCT01758640|"~     A prospective, randomized, longitudinal, open label, parallel group clinical trial was~     designed to compare the proportions of failure to reach INR target 2.5-3.5 with either:~     small dose warfarin (<5 mg/day) or phenindione (<100 mg/day), in high-risk pregnant and~     non-pregnant patients with bileaflet mechanical heart valve prosthesis.~   "
99202|NCT01758627|"~     In patients with advanced heart failure (HF), systemic congestion is the main indication for~     hospitalization. Recent evidence has highlighted the role of fluid retention in the~     pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney~     disease, diuretic resistance, and progression of renal dysfunction often coexist in patients~     with HF and persistent volume overload. This clinical presentation represents the most~     extreme feature of the cardio-renal syndrome. However, available therapeutic options for~     this ominous condition are scarce and limited. Indeed, there are no data from randomized~     control trials using pharmacological interventions that support the beneficial effect on~     survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative~     therapeutic option for reducing volume overload in patients with refractory HF. Current~     literature suggests that it has potential advantages over standard medical treatment~     particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD)~     has been preferred as an additional resource for the treatment of advanced congestive heart~     failure (CHF) compared with hemodialysis because it can provide a more physiological and~     continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical~     functional class and hemodynamic parameters and reduced hospitalization rates in patients~     with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample~     size, prospective observational design with no control group, or inclusion of patients with~     end-stage renal failure. Therefore, well-designed prospective randomized controlled studies~     are mandatory to confirm the effects of PD in these patients.~   "
99203|NCT01758614|"~     The recently published Carotid Occlusion Surgery Study (COSS) failed to show a benefit of~     extracranial-intracranial (EC-IC) bypass surgery over medical therapy in patients with~     symptomatic hemodynamically significant carotid occlusion. Since then on, different~     controversies have been raised on several aspects including the study population,~     qualifications of surgeons and hemodynamic evaluation.~      In COSS protocol, the primary inclusion population is the patient demonstrating occlusion of~     unilateral ICA while the contralateral ICA less than 50% stenosis. Because of the enrollment~     problems, in the final result report, 18% patients suffered from contralateral ICA stenosis~     more than 50%. As we known, COSS utilized oxygen extraction fraction (OEF) ratio by PET as~     the criterion of hemodynamic evaluation. Bilateral ICAs lesion will disturbed the ratio even~     the identifying the subgroup of patients with hemodynamic insufficiency.~      As an interventional trial, the COSS should ensure the certification for the experienced~     surgeons. While for expanding the number of centers and enhancing recruitment, COSS made~     some concessions on the surgeons training and certification. The 15% postoperative event~     rate is not the best that can be achieved according to recent surgical technical~     development.~      The cerebral hemodynamic insufficiency has been considered as the primary pathophysiological~     factor for patients with ICA or MCA occlusion. For these patients, antiplatelet therapy is~     not likely to prevent hemodynamic stroke.EC-IC bypass surgery probably will be the possible~     effective therapy.~      These underlying assumptions deserved further exploration and more strict research.So the~     CMOSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery~     with medical therapy in patients with symptomatic hemodynamically significant carotid~     occlusion.~   "
99204|NCT01758601|"~     The investigators performed this study to evaluate the efficacy of regular ingestion of~     white fish to reduce cardiovascular risk factors in patients with the metabolic syndrome,~     compared to a diet with no fish or seafood at all.~   "
143090|NCT01181687|"~     The purpose of this study is to establish reliability and validity of the Norwegian version~     of the Comfort behavioral scale.~   "
99205|NCT01758588|"~     The purpose of this study is to look at the effectiveness of giving patients who have been~     newly diagnosed with untreated early stage primary myelofibrosis (PMF) a study drug called~     PEGINTRON (also known as pegylated interferon alfa 2b). This intervention will be compared~     to the widely employed watch and wait (best supportive care) approach for early stage PMF,~     in which patients are followed closely and treatment initiated only if the disease~     progresses.~   "
99206|NCT01758575|"~     Single center, non-randomized, interventional pilot study with feasibility analysis after~     enrollment of 20 patients. Adult patients with advanced solid tumors, for whom standard~     palliative treatment with targeted agents as monotherapy is indicated, including~     antiangiogenic tyrosine kinase inhibitors, EGFR inhibitors, mTOR inhibitors, BRAF inhibitors~     and ipilimumab.After feasibility analysis in the first twenty patients, twenty more patients~     will be included in each of the five drug cohorts. Biopsies will be performed to determine~     possible immunohistochemical and histopathological changes in normal tissue, possible~     immunomodulatory changes as expressed by Tcell phenotyping and cytokine profiling and to~     compare tissue (phospho) proteomic and kinase activity profiles before and during therapy~     and also at the development of toxicity.The main objective of this pilot study is to~     determine the biological impact of treatment with targeted agents at the systemic and local~     tissue level in relation to toxicity.~   "
99207|NCT01758562|"~     Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with~     allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis~     due to their treatment.~      70 patients will be randomized in the intervention (Caphosol) or in the standard~     (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary~     endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence~     of pain measured with the NRS-scale (Numeric Rating Scale).~        -  Trial with medical device~   "
99208|NCT01758549|"~     1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of~          the bile duct as well as to manage leaks which occurs following laparoscopic~          gallbladder removal.~        2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and~          results in considerable suffering and cost.~        3. Patients with acute pancreatitis are treated with fluids.~        4. Our aim is to assess whether prophylactic treatment with aggressive intravenous~          hydration prevents ERCP pancreatitis.~        5. In a blinded fashion patients will be randomized to aggressive intravenous versus~          moderate hydration during and aftere ERCP for standard clinical indications.~      Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects~     against ERCP pancreatitis.~   "
99209|NCT01758536|"~     The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving~     neural function and life quality in patients with acute ischemic stroke in China.~   "
99210|NCT01758523|"~     This study will examine the safety and potential benefit of the medication dutasteride to~     help men reduce or stop drinking alcohol.~   "
99211|NCT01758510|"~     The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone~     Marrow Derived stem cells(HYNR-CS-Allo inj), through intrathecal delivery for the~     treatment in patients with amyotrophic lateral sclerosis(ALS).~      This study is an open label, dose up and down study using the 3+3 design to assess the~     safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells(HYNR-CS-Allo inj)~   "
99212|NCT01758497|"~     Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in~     patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the~     efficacy of FICB for this indication. Therefore the objective of this study was to assess~     the analgesic benefit of FICB for post-operative pain management in THA.~      Methods After IRB approval and informed consent, patients having THA at our center in the~     period 2010-2011 were recruited. Eligible patients were adults, ASA physical status I-III,~     and BMI <30) with no contraindication to study procedures. In the PACU, all patients~     received morphine sulfate IVPCA; patients reporting pain > 3 on the NRS-11 despite IVPCA~     were randomized by the method of sealed envelopes to receive US guided injections of 30ml~     0.5% ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca.~      The primary outcome variable was opioid analgesic consumption during the first 24 h~     postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of~     sensory blockade.~   "
99213|NCT01758484|"~     This pilot clinical trial studies supportive care for patients with hematological~     malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality~     of life in this patient population.~   "
99214|NCT01758471|"~     This study is aimed to investigate the effect of acarbose on intestinal microbiome and~     incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.~   "
99215|NCT01758458|"~     This phase I/II trial studies the side effects and best way to give laboratory treated~     autologous T cells together with aldesleukin and to see how well it works in treating~     patients with merkel cell carcinoma that has spread from the primary site (place where it~     started) to other places in the body. Biological therapies, such as cellular adoptive~     immunotherapy, may stimulate the immune system in different ways and stop tumor cells from~     growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving~     cellular adoptive immunotherapy with aldesleukin may be a better treatment for metastatic~     merkel cell carcinoma.~   "
99216|NCT01758445|"~     The purpose of this study is to look at the rates of acute and long term adverse events of~     postoperative proton radiotherapy for complex loco-regional irradiation in women with~     loco-regionally advanced breast cancer. This study specifically includes longitudinal follow~     up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15~     years following proton therapy(PT).~   "
99217|NCT01758432|"~     The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of~     several blood thinner drugs on laboratory tests. The study also is evaluating the blood~     levels of PRT064445 given at different doses.~   "
99300|NCT01757340|"~     The purpose of this study is to determine whether consuming additional leucine during~     calorie restriction induced weight loss has beneficial or harmful effects on multi-organ~     (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut~     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal~     women.~   "
146950|NCT01130948|"~     This study investigates the effect of altitude exposure on sleep, breathing and psychomotor~     performance in healthy subjects.~   "
99218|NCT01758419|"~     Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose~     delivered to each region of the heart in left-sided breast cancer therapy, which allows~     greater sparing of the heart from doses associated with increased complications. However,~     heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The~     damage of the myocytes may lead to not only myocardial perfusion defects, but also in~     functional deterioration, or even in biomarkers. In this study, we will monitor~     cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect~     patterns, and cardiac functional parameters, in order to delineate of RT-related effects and~     clinical impacts.~      Objective: The pilot study aims to investigate the correlation of post-tomotherapy~     cardiovascular effects with myocardial perfusion and cardiac functional studies.~      Methods: The study plans to enroll female breast cancer patients who will undergo local RT~     after their surgery. Patients will receive global risk scoring assessment (Framingham Risk~     Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial~     perfusion image (MPI) at the time points of before and after RT. The results of MPI will be~     analyzed in qualitative visual interpretation of perfusion patterns, and functional~     quantitative data for cardiac functional parameters as well. The patients will be regular~     followed-up in CV OPD. The association between baseline and follow-up MPI, biomarker and~     clinical presentation will be further investigated.~   "
99219|NCT01758406|"~     This study is a prospective, randomized, double blind , controlled trial to assess the~     efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients~     with ischemic heart failure.~   "
99220|NCT01758393|"~     This is a randomized, open-label, single-center clinical trial to compare the efficacy and~     safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related~     Disease. Patients will be followed for three months to measure the primary outcome and~     secondary outcomes.~   "
99221|NCT01758380|"~     To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in~     Muslim patients with type 2 diabetes fasting during Ramadan.~   "
99222|NCT01758367|"~     Decitabine can up-regulate a series of immune associated proteins, including cancer testis~     antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and~     adhesion molecules, which suggests a potential benefit for a following adoptive T cell~     therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T~     cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be~     reduced by treatment of decitabine.~   "
99223|NCT01758354|"~     The purpose of this study is to test the feasibility of a newborn screen assay for Pompe~     disease~   "
99224|NCT01758341|"~     Biliary obstruction is importantly influencing quality of life and survival of patients~     suffering from primary or secondary bile duct malignancies. The aim of this retrospective~     data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM~     EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures~     performed in Austria so far will be analyzed with regard to feasibility and safety of the~     technique. Therefore, the following parameters will be assessed: (among others) technical~     failures during the RFA procedure, complications during the RFA procedure, hospital stay,~     adverse events during hospital stay and until first clinical control after discharge (an~     expected average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results~     of this study should help to better understand important aspects of biliary RFA which may~     positively influence future applications of this method.~   "
99225|NCT01758328|"~     The purpose of this study is to test the safety of specialized white cells from the donor at~     different doses. They are called WT1 sensitized T cells. They have been grown in the lab and~     are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. The~     multiple myeloma cells make and express this protein. The investigators want to learn~     whether the WT1 sensitized T cells will attach to the protein and kill the myeloma cells.~     The investigators want to find out what effects, good and/or bad, it has on the patient and~     multiple myeloma.~   "
99226|NCT01758315|"~     The purpose of the Proactive Reduction of Outpatient Malpractice: Increasing Safety,~     Efficiency, and Satisfaction (PROMISES) project is to assemble a high-level Massachusetts~     consortium to test the impact of powerful quality improvement techniques to accomplish~     innovations and improvements in high risk ambulatory malpractice areas. We will target~     problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test~     ordering and results management 3) follow-up and referral management.~   "
99227|NCT01758302|"~     This one time pilot laboratory study focuses on examining the relationship between different~     types of physical tasks and taste perception of high and low-calorie foods among hungry~     individuals.~   "
99228|NCT01758289|"~     This study was designed to evaluate the effectiveness, safety, and impact on quality of life~     when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on~     hemodialysis who are at risk of developing secondary hyperparathyroidism associated with~     stage V chronic kidney disease.~   "
99229|NCT01758276|"~     This will be a retrospective study. Details on all women who delivered in McGill University~     between 2001-2007 will be retrieved anonymously from the MOND database (McGill University~     Obstetrics and Neonatal database). Women will be divided to 2 groups according to their~     smoking status in pregnancy. Obstetric complications will be recorded in both groups.~   "
99230|NCT01758263|"~     This is a retrospective data analysis of patients with high blood pressure (hypertension)~     who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a~     minimum of 6 month to treat hypertension. These patients will be identified from a large~     medical claims database. This study tests the hypothesis (alternative, higher or lower) that~     average patient monthly health care administrative cost changes after switching from~     metoprolol to nebivolol.~   "
99244|NCT01758081|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and~     will examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma~     hCAP18 levels.~   "
99231|NCT01758250|"~     In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal~     Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical~     Coherence Tomography (OCT) will be used to assess differences in microvascular function and~     density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous~     involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and~     vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD)~     compared to healthy subjects. The microvascular changes will be compared to overall~     treatment response in patients with scleroderma and chronic GVHD as assessments will be made~     before and after the patients start treatment for their diseases and determine if these~     imaging techniques provide valuable and reproducible data when assessing a patient's~     response to treatment for those diseases. In addition, the application of Acoustic Radiation~     Force Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and~     morphea will be evaluated.~      The investigators hypothesize that the vascular and dermal structures are altered in~     patients with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that~     imaging modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural~     alterations and can be used to 1) detect early disease activity, 2) quantify and assess~     response to therapy and 3) quantify and correlate with overall disease activity.~   "
99232|NCT01758237|"~     To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the~     post operative visual symptoms experienced by some patients. The investigators hypothesize~     that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia,~     due to avoidance of the prismatic effect produced by the tear film than those covered.~   "
99233|NCT01758224|"~     Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect~     motor pathways and cause muscle weakness. Respiratory complications due to respiratory~     muscle weakness are common in the terminal stages of MS and contribute to mortality in these~     patients. Respiratory muscle weakness may also impair the performance of coughing and~     aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic~     stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through~     nerve activation. Over the last few years, the study investigators have demonstrated~     efficacy of FMS technology for stimulating respiratory muscles in animal models, able-bodied~     subjects [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will~     investigate the efficacy of using FMS technique for respiratory muscle conditioning in~     patients with MS. Furthermore, the investigators will also compare expiration related~     outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.~      Hypotheses~        1. FMS conditioning of the expiratory muscles can generate significant expiratory flows~          and pressures in patients with MS.~        2. FMS conditioning of expiratory muscles is more effective compared to resistive~          expiratory muscle training (REMT) in patients with MS.~   "
99234|NCT01758211|"~     Little is known about the effect of fMRI navigation in the intracranial arteriovenous~     malformation surgery. The investigators aim to perform a multicenter prospective randomized~     single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain~     arteriovenous malformation surgery.~   "
99235|NCT01758198|"~     The purpose of this study is to compare the clinical efficacy including joint damage~     progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.~   "
99236|NCT01758185|"~     The objective of this study was to evaluate the safety and immunogenicity of one inactivated~     split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.~   "
99237|NCT01758172|"~     From postoperative patients having undergone pancreaticoduodenectomy;~        1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6%~          Voluven~        2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory~          parameters of the patient~        3. To compare the safety of the 2 intravenous colloids in the patient population~   "
99238|NCT01758159|"~     Complementary feeding diet in developing countries cannot meet iron requirements of infants~     and young children. Iron supplementation is mostly used to treat iron deficiency whereas~     iron fortification is cost-effective strategy to control iron deficiency in developing~     countries. However, a recent study showed that iron fortification imposed negative impact on~     gut microbiota by increasing colonization of gut pathogen over beneficial bacteria. Gut~     microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal~     mucosal barrier function and pathogen displacement. Iron is essential for growth and~     virulence of most gut pathogens and so iron supplementation might have similar negative~     impact on gut microbiota composition. Therefore, nutrition interventions would not be~     justified by assessing micronutrient status alone ignoring any possible deterioration of gut~     microbiota. The investigators hypothesized that optimizing the nutrient intake from locally~     available foods according to complementary feeding recommendation (CFR) can improve the iron~     status of these children while maintaining healthy gut microbiota composition.~      A randomized, placebo-controlled, community-based, intervention trial will be conducted in~     Ayeyarwady division of Myanmar where childhood undernutrition is prevalent. The aim of this~     study is to compare the effect of optimized CFR to iron supplementation on iron status and~     gut microbiota composition of 1-2years old Myanmar children. Cluster randomization will be~     done at the village level to randomly allocate the villages into CFR or non-CFR villages.~     Individual randomization will be done to randomly assign each child into iron or placebo~     syrup so that individual children will receive one of 4 treatment groups (CFR, Fe, CFR + Fe,~     and Control) for a period of 24 weeks. Based on expected between-groups difference of~     hemoglobin 5g/L, at 80% power, 5% level of significance, 15% drop-out rate; after taking~     into account the cluster effect; required sample will be 109 per group (total = 436). A~     sub-sample of 15 children from each group will be randomly selected for gut microbiota~     assessment (total = 60). Blood samples for iron status and stool samples for gut microbiota~     assessment will be collected at baseline and endline. Anthropometric measurements, usual~     intake of iron and infectious disease morbidity will also be assessed.~   "
99239|NCT01758146|"~     To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase~     inhibitors in postmenopausal patients with early breast cancer in terms of:~      i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall~     survival~   "
99240|NCT01758133|"~     The aim of this study is to determine whether medical clown activity enables relaxation of~     mothers of premature infants, and as a result increases their breast milk production.~   "
99241|NCT01758120|"~     Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone~     alone in patients with advanced-stage IgA nephropathy.~   "
99242|NCT01758107|"~     Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and~     Calcineurin inhibitor withdrawal.~   "
99243|NCT01758094|"~     The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with~     insulin resistance and influence of testosterone treatment on this cytokine in patients with~     idiopathic hypogonadotropic hypogonadism.~   "
99283|NCT01757561|"~     the purpose of this study is to investigate whether propofol and sevoflurane have difference~     effect on cerebral oxygenation .~   "
99245|NCT01758068|"~     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits~     even more vulnerability to the environment due to poor self regulatory heat mechanisms,~     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight~     as water loss from their skin during the first week of life. Many strategies have been~     utilized by neonatologists to decrease this water loss. Edible coconut oil application on~     the skin acts as a non permeable barrier and can help in achieving this. Hence the~     investigators decided to undertake this study to objectively assess the reduction in water~     loss from skin after oil application.~   "
99246|NCT01758055|"~     The purpose of this study is evaluating the safety of endobronchial transplantation of~     autologous mesenchymal stem cells derived bone marrow in patients with emphysema.~   "
99247|NCT01758042|"~     The main purpose of this study is to examine the outcome of a combined bone marrow and~     kidney transplant from a partially matched related (haploidentical or haplo) donor. This~     is a pilot study, you are being asked to participate because you have a blood disorder and~     kidney disease. The aim of the combined transplant is to treat both your underlying blood~     disorder and kidney disease. We expect to have about 10 people participate in this study.~      Additionally, because the same person who is donating the kidney will also be donating the~     bone marrow, there may be a smaller chance of kidney rejection and less need for long-term~     use of anti-rejection drugs.~      Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to~     prepare a subject's body for bone marrow transplant. This is associated with a high risk for~     serious complications, even in subjects without kidney disease. This therapy can be toxic to~     the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that~     standard therapy may be associated with a higher risk of a complication called graft versus~     host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently,~     less intense chemotherapy and radiation regimens have been employed (these are called~     reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have~     allowed older and less healthy patients to undergo bone marrow transplant. In this study, a~     reduced intensity regimen of chemotherapy and radiation will be used with the intent of~     producing fewer toxicities than standard therapy.~      Typical therapy following a standard kidney transplant includes multiple lifelong~     medications that aim to prevent the recipient's body from attacking or rejecting the donated~     kidney. These are called immunosuppressant drugs and they work by quieting the recipient's~     immune system to allow the donated kidney to function properly. One goal in our study is to~     decrease the duration you will need to be on immunosuppressant drugs following your kidney~     transplant as the bone marrow transplant will provide you with the donor's immune system~     which should not attack the donor kidney.~   "
99248|NCT01758029|"~     This study will be conducted as a prospective, single-center (multiple clinics), single-arm~     open phase IV study.~      the study will follow hypogonadal patients, and aimed to confirm the hypothesis that~     testosterone undecanoate improves the patient satisfaction and quality of life, with~     parallel improvement in their spouses's quality of life and satisfaction. Each~     patient/spouse will serve as his own control.~   "
99249|NCT01758016|"~     Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome~     . The risk for vascular complications including: Intra uterine growth restriction (20%),~     hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly~     greater than those in background populations. The risk of developing vascular complications~     in diabetes pregnancies although is correlated with the severity and length of the disease~     is not fully understood. Enhanced oxidation has been suggested to be the underlying~     abnormality responsible for some of the complications of diabetes.~      Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best~     understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells.~     Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue~     damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the~     release of heme iron.~      The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles~     denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%,~     48% and 36%, respectively. In the western world. A total of five independent longitudinal~     studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold~     increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to~     determine whether HP genotype plays important role in development of vascular complications~     in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing~     gestational diabetes (GDM)~   "
99250|NCT01758003|"~     The primary aim of this research is to examine physical activity in a healthy population~     aged over 40 years old.~      Subsidiary aims of this research are:~        1. To establish normative values for physical activity levels, exercise capacity, quality~          of life and readiness to change physical activity behaviour (stages of change,~          self-efficacy, decisional balance and processes of change) in a healthy population~          age-matched to a population with bronchiectasis.~        2. To explore physical activity levels, exercise capacity and quality of life in a healthy~          population age-matched to a population with bronchiectasis.~        3. To explore readiness to change physical activity behaviour (stages of change,~          self-efficacy, processes of change and decisional balance) in a healthy population~          compared to a population with bronchiectasis.~   "
99251|NCT01757990|"~     The aim of the present investigation was to evaluate the effect of stevioside and~     rebaudioside on several variables related to caries development. Two approaches were~     performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in~     vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside~     on plaque-pH.~   "
99252|NCT01757977|"~     The investigators have performed a number of studies on novel airway devices. In this~     randomized controlled trial he investigators would like to compare the performance of a new~     double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard~     double lumen tube.~   "
99253|NCT01757964|"~     In this study, the investigators want to see if Bacteriotherapy (also referred to as stool~     transplantation) improves the symptoms and decreases inflammation in children with~     Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative~     Colitis. Additionally, researchers want to learn whether this experimental therapy delays~     the need for starting additional medications to treat pediatric IBD.~   "
99254|NCT01757951|"~     A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures~     are treated by both medial and lateral osteosynthesis, sometimes accompanied by~     osteosynthesis of the posterior malleolus. There is significant evidence that fractures of~     the lateral malleolus can be treated conservatively if the medial side is stable. However,~     there isn't a single study comparing standard bi- or trimalleolar fixation with only medial~     side osteosynthesis and postoperative immobilization with a cast.~   "
99284|NCT01757548|"~     The purpose of this study is to determine whether high ligation of spermatic vein by open~     operation and microsurgery for patients with are effective in the treatment of varicocele~     and to determine which surgical option is better.~   "
99255|NCT01757938|"~     Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in~     sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme~     on HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and~     feasibility studies have demonstrated that AMC programmes can be effectively delivered to~     hyperendemic communities, such as those in SSA. Despite these recommendations, the potential~     effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit~     undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal~     surgical training limit uptake in low-income countries. Training and implementation by~     non-physician health providers is dampened by a need to perform approximately 100 procedures~     to achieve satisfactory operative time and adverse effect rates. The investigators performed~     a randomised controlled effectiveness study to compare the shang ring (SR) with standard~     forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally~     trained surgeon in Mbarara, western Uganda.~   "
99256|NCT01757925|"~     Recently, researchers have been interested in the use of game play, mechanics and psychology~     for health-related engagement and behavior change. While initial studies have shown some~     increases in health knowledge and/or behavior through gaming, there remains concern that the~     vehicle for change is associated with a perceived sedentary behavior (6).~      More recently, commercially available gaming devices are able to directly promote physical~     activity through a new set of kinetic controllers added to the gaming experience. UHG~     plans to evaluate the most recent of these kinetic controller technologies in the context of~     a second iteration of JOIN (described above) to be implemented among a pilot group of~     overweight and/or obese children whose BMI percentile is above the 85th.~      This study will evaluate the effect of a commercial controller-free Exercise Gaming and~     Entertainment Experience (EGEE) on physical activity levels in the context of a weight~     management program in approximately 70 children ages 6 to12. The study will compare the~     differences in physical activity levels over 16 weeks in two groups of children.~   "
99257|NCT01757912|"~     The endotracheal tube secures free airway in patients undergoing surgical procedures or~     mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs~     to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A~     cuff pressure in excess of the target range is associated with a risk of tracheal injury,~     whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of~     subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is~     unknown whether the cuff pressure changes following changes in body position of the patient.~     The objective of this study is to investigate to which extent - if any - cuff pressures~     change after body position changes of the patient.~   "
99258|NCT01757899|"~     The purpose of this study is to investigate the effects of prolonged low-dose~     methylprednisolone infusion on pulmonary function (LIS and ventilation-free days), extra~     pulmonary organ function (PMODS score), inflammatory markers - RCP (Reactive C Protein), IL6~     (Interleukine 6), TNFα (Tumor Necrosis Factor), IL8 (Interleukine 8), IL10 (Interleukine 10)~     and length of Pediatric Intensive Care Unit (PICU) stay in early ALI/ARDS in children.~   "
99259|NCT01757886|"~     The prognostic value of inflammatory markers in acute coronary syndrome has been extensively~     demonstrated, however it is still unknown whether there is an association between~     circulating and local (thrombus) inflammatory molecules, and the subset of molecules that~     provide better prognostic information in patients with ST-elevation acute coronary syndrome.~   "
99260|NCT01757873|"~     This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety~     and efficacy for a period of 6 weeks.~   "
99261|NCT01757860|"~     Study Phase: Phase 1~      Primary Objective:~      • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in~     healthy subjects~      Secondary Objectives:~        -  To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single~          oral doses of CARD-024~        -  To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin~          activity (PRA) and blood pressure (BP), biological markers of activity, following~          ascending single oral doses of CARD-024~   "
99262|NCT01757847|"~     This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group~     intervention to an active control group in a sample of 154 overweight or obese binge eating~     Veterans who have completed the VA's national behavioral weight management program (MOVE!).~     This study anticipates that the ACT intervention will reduce binge eating and distress while~     improving functioning and maintenance of weight loss.~   "
99263|NCT01757834|"~     Shear wave ultrasound elastography is a new technique of finding the softness or hardness in~     tissue by applying a push generated by the machine. This technique will help in diagnosing~     malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.~   "
99264|NCT01757821|"~     The goal of stroke rehabilitation is to restore function to the weak side of the body.~     However, this is often a difficult task to accomplish due to not only to damage from the~     stroke, but from increased excitability in the non-stroke side of the brain that inhibits~     the stroke side from functioning optimally. Repetitive transcranial magnetic stimulation~     (rTMS) is a non-invasive form of brain stimulation that can enhance excitability in the~     stroke side when applied at a low-frequency on the non-stroke side. By inhibiting the~     inhibition (i.e. disinhibition), rTMS promotes adaptive brain reorganization following~     stroke. Previous research in healthy individuals demonstrates enhanced effects of~     low-frequency rTMS when it is preceded by high-frequency (excitatory) rTMS stimulation known~     as priming. Our lab previously demonstrated the safety of 6-Hz priming with low-frequency~     rTMS in both adults and children with chronic stroke. However, it is currently unknown~     whether or not the addition of priming stimulation to low-frequency rTMS enhances~     excitability in the stroke hemisphere. Our study will examine three rTMS interventions in~     twelve adults (at least 18 years): 1.) 10 minutes of real priming followed by 10 minutes of~     low-frequency rTMS, 2.) 10 minutes of fake priming followed by 10 minutes of low-frequency~     rTMS, 3.) 20 minutes of low-frequency rTMS only. Participants will receive all three~     interventions in randomized order. Each week, participants will complete two pretest and 3~     posttest sessions consisting of behavioral measures of weak upper extremity function and~     cortical excitability in addition to receiving one rTMS intervention. Following each week of~     testing and treatment, subjects will take a one week rest break before crossing-over to~     receive another intervention. We hypothesize the following: 1.) Primed rTMS will result in~     significantly reduced inhibition and significantly increased excitation on the stroke side~     vs. fake primed rTMS or low-frequency rTMS given alone and 2.) Primed rTMS will result in~     greater improvements of paretic hand function. This study is innovative in that it intends~     to compare primed and unprimed rTMS in the stroke brain that could acknowledge a more~     effective delivery method of rTMS to potentially yield greater rehabilitative outcomes.~   "
99285|NCT01757535|"~     This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de~     novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or~     chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/~     Complete remission with incomplete blood count recovery (CRi) following induction with or~     without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a~     hypomethylating agent will be excluded from the study.~   "
99265|NCT01757808|"~     The purpose of this study is to assess the safety of ranolazine in people with pulmonary~     arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies:~     ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or~     iloprost. The primary objective is:~        -  To estimate the effect of ranolazine administration on acute hemodynamics.~        -  To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after~          12 weeks of therapy~        -  To assess changes in right ventricular function after 12 weeks of therapy.~   "
99266|NCT01757795|"~     Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics~     of escalating single doses and multiple doses of SP-8203~   "
99267|NCT01757782|"~     The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary~     Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns~     and to study risk factors of MAS developing into PPHN.~   "
99268|NCT01757769|"~     The purpose of this study is to confirm in a larger population in Europe the effectiveness~     and safety observed with silodosin in previous clinical trials.~   "
99269|NCT01757756|"~     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple~     oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight~     and obese subjects.~   "
99270|NCT01757743|"~     This project will evaluate fluid balance and oedema formation in children with the same~     congenital heart disease (Atrial Septal Defect) who will either go through heart surgery~     with the use of Cardio Pulmonary Bypass and hypothermia or through interventional~     catheterization. The investigators will measure interstitial colloid osmotic pressure,~     distribution of proteins and cytokines. The study hypothesis is that Oedema developed~     during heart surgery is caused by reduced colloid osmotic pressure gradient through the~     capillary membrane.~   "
99271|NCT01757730|"~     Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of~     soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid~     in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound~     vibration via a speaker placed outside the scan room which is connecting plastic drum via a~     plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft~     tissues such as liver, heart, kidneys, breast etc.~   "
99272|NCT01757717|"~     The purpose of this study is to see if using a form of imaging during surgery helps the~     doctors to guide the placement of radiation catheters more accurately.~      This method, called image-guided surgical navigation may allow the doctors to deliver~     radiation to the tumor that the patient needs and decrease the amount of radiation delivered~     to the nearby areas.~   "
99273|NCT01757704|"~     The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery.~     It consists of two main elements namely, opening of both pleura after the patient is on CPB~     (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to~     ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the~     CPB. The aim of this study is to analyze in a randomized manner two groups of patients to~     establish if one or both components are of primary importance for the effectiveness of the~     de-airing technique.~   "
99274|NCT01757691|"~     To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with~     suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment~   "
99275|NCT01757678|"~     To determine the diagnostic performance of FFRCT by coronary computed tomographic~     angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the~     presence of a hemodynamically significant coronary lesion, using direct measurement of~     fractional flow reserve (FFR) during cardiac catheterization as a reference standard.~   "
99276|NCT01757665|"~     The objective of this trial is to confirm that the modifications to tissue processing, valve~     sterilization and packaging do not raise any new questions of safety and effectiveness in~     subjects who require replacement of their native or prosthetic aortic or mitral valve.~   "
99277|NCT01757639|"~     This phase I trial studies the side effects and best dose of ipilimumab and how well it~     works in treating patients with high-risk myelodysplastic syndrome or acute myeloid leukemia~     that has come back or no longer responds to treatment. Monoclonal antibodies, such as~     ipilimumab, may interfere with the ability of cancer cells to grow and spread.~   "
99278|NCT01757626|"~     The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8)~     combined with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for~     treating neuroblastoma.~   "
99279|NCT01757613|"~     In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated~     with respect to safety and efficacy in order to identify the optimal concentration in the~     topical formulation.~      The main objective of the trial is to determine the optimal concentration of the active~     agent in the topical formulation as quantified by the change of the number of skin~     alterations in pre-defined areas in a time period from inclusion in the trial until the end~     of treatment (3 months) or prior complete healing.~   "
99280|NCT01757600|"~     To evaluate the correlations between anatomical and functional changes studied with~     microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of~     idiopathic macular hole (MH).~   "
99281|NCT01757587|"~     The main objective is to show that the addition of Galvus versus placebo in patients with~     type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin~     properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.~      The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c~     less than 7%) after 3 months of treatment with Galvus or placebo~   "
99282|NCT01757574|"~     The objectives of this study are to determine the safety, tolerability and preliminary~     efficacy of alemtuzumab for infusion for the treatment of CIDP. Eligible subjects will be~     treated with alemtuzumab at the beginning of the study and then followed for three years.~     During the three year period, subjects will under go monthly safety evaluations consisting~     of blood and urine testing, symptom surveys and examination. Detailed neurological testing~     including nerve conduction testing, Rasch-built Overall Disability Scale (CIDP/RODS) and~     Overall Neuropathy Limitations Scale (ONLS) assessments will be performed every six months~     for three years.~      The study will also investigate and compare the responsiveness of the outcome measures being~     used.~   "
99286|NCT01757522|"~     Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right~     ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary~     vascular resistances and pressure load. This can be prevented by modifying ventilator~     settings, using vasopressors or inotropes or even by prone positionning.But to do so, right~     ventricular dysfonction has to be detected. Echocardiography has emerged as a first line~     tool to diagnose right heart failure. Recently, strain analysis showed promising results to~     detect early right ventricle abnormalities in other settings such as pulmonary hypertension~     or scleroderma. We therefore decided to determine whether 2D strain could help detect early~     right ventricular dysfunction in ARDS.~   "
99287|NCT01757509|"~     The aim of this study is to investigate if set dancing is beneficial and feasible for those~     with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that:~        -  Participants will be able to partake fully in the intervention without reporting~          adverse events.~        -  There will be evidence of gains in functional exercise tolerance, balance, motor~          performance and quality of life in those with Parkinson's disease who participate in~          eight weeks of set dancing classes compared to a control group.~   "
99288|NCT01757496|"~     RSV bronchiolitis in children is still associated with significant morbidity and mortality.~     RSV infection results in increased mucus production, edema and inflammation at the lower~     airways and impaired mucociliary clearance. Infants and children under the age of 1 year are~     particularly vulnerable to complications such as atelectasis and secondary bacterial~     infection. These children often need non-invasive or invasive ventilation. Atelectasis is~     common in these children because of smaller airways and decreased cough strength. There is~     still much uncertainty about the treatment of RSV. Treatment consists primarily of~     supportive therapy such as tube feeding and additional respiratory support if necessary.~     There is also limited evidence about the use of nebulizers with beta-agonists and/or~     hypertonic saline.~      The cough assist is a mechanical in- and exsufflator used primarily in patients with~     neuromuscular diseases to augment cough capacity. In these patients, it was demonstrated~     that the use of assisted cough resulted in a significant decrease in the number of~     respiratory infections. Moreover, there is evidence that when used in the case of an acute~     respiratory deterioration such a massive atelectasis, the atelectasis can be corrected and~     intubation can be avoided. The aim of this study is to investigate if the use of the~     CoughAssist device in children with RSV bronchiolitis is associated with a better~     respiratory outcome.~   "
99289|NCT01757483|"~     This study is designed to evaluate the effectiveness of the current ticagrelor risk~     minimisation strategy in Canada through a prescriber knowledge and understanding (KAU)~     survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug~     interactions) and ASA dosage.~   "
99290|NCT01757470|"~     Effectiveness of risk minimisation interventions for vandetanib in Canada~   "
99291|NCT01757457|"~     Intracoronary abciximab administration during primary percutaneous coronary intervention~     (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was~     to assess whether abciximab administration route could influence its anti-inflammatory~     effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an~     intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of~     inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.~   "
99292|NCT01757444|"~     In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could~     offer potential advantages over fixed level pressure support, in particular, in patients~     with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an~     innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency~     while delivering the correct level of ventilation each user requires, whatever their body~     position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the~     initial titration of therapy, while providing long term comfort and assuring therapy~     compliance. However, studies on the physiologic and clinical effects have not yet been~     performed. The aim of our singled-blind randomised multicentre controlled trial is to~     prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the~     AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange,~     symptoms, body composition, level of physical activity and health-related quality of life in~     OHS patients.~   "
99293|NCT01757431|"~     Protocol is intended to characterize the overall safety and tolerability of eculizumab in~     this population.~   "
99294|NCT01757418|"~     The purpose of this study is to determine whether intravenous immune globulin is safe and~     effective in the acute treatment of pain crises in sickle cell disease.~      Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development~     (OOPD)~   "
99295|NCT01757405|"~     The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a~     six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.~   "
99296|NCT01757392|"~     The primary objective of this study is to determine the safety of Candin® (Candida albicans~     Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common~     warts (Verruca vulgaris).~   "
99297|NCT01757379|"~     The purpose of the study is to evaluate the bioavailability of acetate, propionate and~     butyrate in healthy humans using a stable isotope technology.~      In addition the level of acetate, propionate and butyrate production from inulin will be~     determined using the principle of isotope dilution.~   "
99298|NCT01757366|"~     Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in~     Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3~     in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.~   "
99299|NCT01757353|"~     The goal of this research study is to compare three harm reduction approaches for at-risk~     college student drinkers. One approach provides generic risk-related information after an~     initial interview/questionnaire assessment session. A second approach uses an established~     motivational interviewing framework (Brief Alcohol Screening and Intervention for College~     Students; BASICS) that provides personalized feedback in a follow-up session. A third~     approach also uses BASICS, but tests the utility of a personality-informed module for this~     approach that is informed by the social investment hypothesis.~   "
101708|NCT01725802|"~     In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD~     solution (ND0612) on the safety and PK profile of LD will be examined.~   "
99301|NCT01757327|"~     This randomized phase II trial studies the effects of erismodegib (LDE225) on disseminated~     tumor cells (DTCs) in patients with stage III-III estrogen receptor (ER)-negative and human~     epidermal growth factor receptor 2 (HER2)-negative breast cancer. The presence of DTCs after~     completing treatment for breast cancer may be linked to recurrence of the disease. LDE225~     may eliminate DTCs in bone marrow and reduce the risk of recurrence.~   "
99302|NCT01757314|"~     When surgery is performed under general anesthesia, a catheter is placed in a vein to~     administer drugs and saline. During major operations, an additional catheter is placed in an~     artery in order to measure the blood pressure closely and withdraw blood samples at frequent~     intervals for various laboratory tests. This arterial catheter is usually placed by feeling~     the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This~     procedure, at times, leads to delays and failures due to an inability to feel the arterial~     pulsation well either due to the patients' anatomy or the anesthetic effect. This study will~     determine whether training Anesthesiology Residents in the use of ultrasound technology and~     its application in identifying an artery can prevent the problems associated with the~     conventional palpation technique. Our finding will lead to better and safer anesthetic~     management of patients presenting for a major surgical procedure. Furthermore, the finding~     will help us in introducing the education and training of ultrasound-guided arterial~     catheter placement in our Residency Program.~      The investigators propose to follow anesthesia residents over a course of 3 years assessing~     their skill level for both palpation and ultrasound technique.~   "
99303|NCT01757301|"~     Pain is the most common presenting symptom in medical outpatients, and depression and~     anxiety are the two most common mental disorders. All three conditions are often~     inadequately treated and result in substantial disability, reduced health-related quality of~     life, and increased health care costs and utilization. Additionally, pain, anxiety, and~     depression (PAD) are frequently comorbid with one another and have reciprocal negative~     effects on treatment response and additive effects on adverse health outcomes. The PAD triad~     is especially burdensome in Veterans, with their high prevalence of chronic pain,~     depression, PTSD, and other anxiety disorders. The Comprehensive vs. Assisted Management of~     Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial~     designed to test the relative effectiveness of a lower-resource vs. a higher-resource~     enhancement of usual primary care in the management of Veterans suffering from with pain~     plus comorbid anxiety and/or depression.~   "
99304|NCT01757288|"~     The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and~     carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no~     published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The~     investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel~     (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component~     using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily~     radiation or paclitaxel with with carboplatin concurrent with daily radiation.~   "
99305|NCT01757275|"~     To describe the rate of clinically significant rebleeding during 72 hours continuous i.v.~     infusion of high dose esomeprazole Na in patients in China with primary successful~     endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in~   "
99306|NCT01757262|"~     Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12~     Receptor Inhibition Effects of Ticagrelor and Clopidogrel~   "
99307|NCT01757249|"~     Endometriosis is a hormone dependent disease of women, in which endometrial tissue (the~     cells which line the uterus or womb) are found outside the uterus (womb). Some women with~     endometriosis may be infertile. However, treatments for infertility such as in vitro~     fertilization (IVF) or IVF with intracytoplasmic sperm injection (IVF-ICSI) appear to be~     less successful, i.e. the pregnancy rates are lower, for women with endometriosis than for~     women who may be infertile for other reasons.~      Since endometriosis is hormone dependent, it has been suggested that suppressing the~     activity of hormones produced by the ovaries (which affect endometrial growth) may~     inactivate endometriosis and so increase the chances of pregnancy. Recently it has been~     proposed that taking the oral contraceptive pill (OCP) for 6 to 8 weeks before IVF or~     IVF-ICSI treatment could be used for this purpose.~      For our study, which is a randomised controlled trial, women with endometriosis meeting the~     study criteria planning to undergo IVF or IVF-ICSI at the Oxford Fertility Unit will be~     recruited. Study participants will be randomised into 2 arms: experimental group and control~     group. The experimental group will be instructed to complete an 8 week course of OCP before~     beginning standard IVF treatment. The control group do not take any study medication before~     beginning standard IVF treatment. The IVF or IVF-ICSI treatment for both groups is not~     altered by participation in the study.~      The aim of the study will be to determine if pretreatment with OCP improves IVF or IVF-ICSI~     success rates, such as live birth and pregnancy rates, in patients who suffer from~     endometriosis. The study is funded by the Oxford Fertility Unit.~   "
99308|NCT01757236|"~     The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination~     therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive~     prosthetic hip joint infection with a one-stage surgical treatment.~   "
99309|NCT01757223|"~     The proposed Phase I/II clinical trial will be used to determine the safety and toxicity of~     direct administration of the vector AdVEGF-All6A+ to the ischemic myocardium and to generate~     preliminary evidence regarding whether direct administration of AdVEGF-All6A+ to the~     ischemic myocardium will induce growth of collateral blood vessels and improve cardiac~     function. This is a three-part, multinational/multi-center, placebo controlled study.~   "
99330|NCT01756950|"~     The purpose of this study is to assess in healthy subjects the safety, tolerability,~     pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal~     antibody against influenza A viruses.~   "
99331|NCT01756937|"~     Efficacy and safety of Imotun capsule in osteoarthritis of the knee~   "
99332|NCT01756924|"~     To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe~     as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic~     joint or spacer infections~   "
99415|NCT01755832|"~     The purpose of this study is to investigate the effects of heated pool group exercises for~     patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue,~     stiffness and ability to carry out daily activities).~   "
99310|NCT01757210|"~     Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting~     that cancer patients experience after treatment. Aprepitant has been well-studied in adults,~     but not in children. Data from adult studies has shown aprepitant to be safe. It has also~     been shown to be effective in lessening the amount of nausea and vomiting that adult~     patients experience. Because aprepitant has been shown to be safe and effective, the~     investigators have been using it in pediatric patients at this hospital as standard of care.~     The investigators will be surveying patients already receiving aprepitant for prevention of~     chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they~     experience. The investigators will also be surveying these patients to determine what their~     appetite is like and if they experience any disruptions in activities of daily living. The~     investigators are also going to be assessing any side effects these patients experience from~     receiving aprepitant.~   "
99311|NCT01757197|"~     The purpose of this study is to determine if Tocilizumab is a safe and effective treatment~     for steroid-refractory acute graft versus host disease.~   "
99312|NCT01757184|"~     This Phase 3 study will evaluate the efficacy and safety of 1 mg/kg IV infusions of SBC-102~     (sebelipase alfa) administered every other week in patients with late onset lysosomal acid~     lipase (LAL) deficiency (cholesteryl ester storage disease).~      Late onset LAL Deficiency is an underappreciated cause of cirrhosis, liver failure and~     dyslipidemia. There is currently no standard treatment for LAL Deficiency other than~     supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option~     for LAL Deficiency patients.~   "
99313|NCT01757171|"~     Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard~     administration dose and schedule. This application is a non-labeled indication for~     cabazitaxel and will inform future drug development in gastroesophageal malignancies, where~     docetaxel remains an approved first line agent, but is not routinely used due to excessive~     toxicity and marginal efficacy.~      At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel~     in refractory gastric cancer, with preferential activity in one or more gastric cancer~     subtypes~   "
99314|NCT01757158|"~     The primary curative treatment of lung cancer patients is surgery, chemotherapy and/or~     radiation therapy (either or all depending on the extent of disease). Surgical resection~     usually requires removal of a lobe of the lung (lobectomy). There are, however, some~     patients who are unable to have a lobectomy. There are several reasons why a patient should~     not have a lobectomy including prior operations in the same area of the lung or poor lung~     functions. Sub-lobe operations (less than a full lobectomy), are alternatives for these~     patients. Types of sub-lobe operations include wedge resection or segmentectomy.~      However, a randomized trial in early stage lung cancer patients that compared lobectomy~     versus wedge resection showed worse local control of cancer with wedge resection. Therefore,~     localized disease wedge resection is considered an inadequate operation. This inadequacy can~     be compensated if radiation seeds are added to the site of wedge resection. Iodine-125~     (I-125) is the most commonly used radiation seed for this purpose. I-125, however,~     unfortunately has a relatively long half life (time taken for activity to become half) of 2~     months. Therefore, the patient is technically 'radioactive' for an average of 6 months to 1~     year. This can seriously compromise quality of life.~      Cesium-131 is another radiation seed that may more effectively treat lung cancer patients.~     Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy~     to I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients~     who receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as~     compared to 180 days (6 months) with I-125. The objective of this study is the use Cs-131~     radiation seeds in lung cancer patients who are planning to undergo a wedge resection for~     localized disease and follow the patients for cancer control and toxicity. These results~     will be compared to pre-existing data for I-125 treatment outcomes in lung cancer patients~     who have had a wedge resection for localized disease.~   "
99315|NCT01757145|"~     The purpose of this study is to determine whether Eltrombopag may shorten time to platelet~     engraftment after allogeneic cord blood transplantation.~   "
99316|NCT01757132|"~     The objective of the PAS-01 study is to assess the safety of the intraocular as measured by~     the cumulative incidence of patients who within 5 years after implantation experience~     persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best~     corrected distance visual acuity >2 lines from pre-surgery baseline level).~      The study will test the null hypothesis that the percentage of patients who experience~     persistent vision-impairing corneal edema is >17% against the alternative that the~     percentage is <17%. The null hypothesis will be rejected if the upper bound of the two-sided~     95% confidence integral for the observed percentage is <17%.~   "
99317|NCT01757119|"~     The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount~     of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous~     sulphate) in women with iron deficiency anaemia.~   "
99318|NCT01757106|"~     Purpose of this study is to test whether xenon application during off-pump-coronary artery~     bypass (OPCAB)-surgery is safe and feasible.~   "
99319|NCT01757093|"~     The purpose of this study is to compare the oxygen consumption and energy expenditure during~     the spontaneous breathing trial.~   "
99320|NCT01757080|"~     OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise~     test in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of~     40 elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50~     ±5.85 years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional~     status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C),~     high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The~     significance level was set at p<0.05.~   "
99333|NCT01756911|"~     Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm~     Repair.~      The objectives of the study is to determine the efficacy, safety and performance of the MFM~     and its delivery system in patients at high surgical risk presenting with a type II, III~     thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation,~     according to the Crawford classification.~   "
99334|NCT01756898|"~     The purpose of this research study is to gather scientific information about the~     effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult~     subjects with atopic dermatitis.~   "
99344|NCT01756768|"~     This will be an open-label, single-center study to evaluate the mass-balance and~     pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single~     oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991.~     Subjects will be checked in to the research unit from approximately 12 hours prior to dosing~     and remain in house until greater than 90% of the administered radioactivity is collected~     from bodily excreta or until less than 1% of the administered radioactivity is recovered~     from excreta on consecutive days. This study will investigate the extent of involvement of~     the renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the~     compound's major metabolites.~   "
99321|NCT01757067|"~     Premature ventricular contractions (PVC) are a very common irregular heart beat~     (arrhythmias) even in patients without heart disease. Frequent PVCs are thought to occur in~     about 1-4% of the general population. Many patients with PVCs complain about skipping of~     their heart (palpitations), shortness of breath and feeling tired. In some patients PVCs may~     also result in weakening of the heart muscle (heart failure), which might be reversible with~     suppression of the PVCs.~      A common way to get rid of PVCs is an ablation procedure during which a small area of heart~     muscle that creates the PVCs is cauterized, so that it can no longer cause PVCs. This has~     been performed for many years and is an overall safe and effective procedure to eliminate~     PVCs. In the ablation, a catheter with an electrode at its tip is guided with moving X-rays~     (fluoroscopy) displayed on a video screen to the exact site inside the heart where cells~     give off the electrical signals that stimulate the abnormal heart rhythm. Radiofrequency~     energy (similar to microwave heat) is transmitted from the catheter tip to the area. This~     destroys carefully selected heart muscle cells in a very small area (about 1/5 of an inch)~     and can stop the area from creating the extra impulses that cause the extra heartbeats.~     Additionally, some medications have the ability to suppress PVCs (antiarrhythmic~     medications). PVC ablation and antiarrhythmic medications have both been used to treat~     patients with PVC's and a reduced heart function. The heart function is referred to as~     ejection fraction (measured by cardiac ultrasound (echocardiogram). In this study it will be~     required the ejection fraction will be less than less than or equal to 45% (with 55% or more~     being normal).~      If enrolled in the study there is a 50/50 chance (like a coin toss and referred to as~     randomization) that the patient will either continue on the best currently available medical~     treatment for a weak heart muscle (as determined by the doctor) or will undergo a PVC~     catheter ablation (with a possible second ablation or antiarrhythmic medication, if the~     first ablation was not a success).~      All patients in the study will continue to take the best possible medications for the heart~     muscle weakness. If the patient is randomized to not undergo the ablation they will be~     monitored and at the end of 6 months of participation may choose to have the PVC ablation.~     If a deterioration may occur patients in the control group can have an ablation earlier.~   "
99322|NCT01757054|"~     The main hypothesis of this study is that there will be a significant increase of~     Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy~     humans following daily consumption of a probiotic supplement containing these specific~     strains of probiotic bacteria.~   "
99323|NCT01757041|"~     Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide.~     Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal~     sepsis (EOS, in <7 days of life) in sSA. In other regions, maternal carriage is associated~     with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes~     (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on~     maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with~     important consequences for public health interventions.~      Through investigation of maternal carriage and perinatal outcomes at three different sites:~     rural, semi-rural and urban, this study will provide a comprehensive description of the~     burden of GBS in coastal Kenya, informing public health policy and driving forward~     interventions. Risk factors for maternal colonisation and invasive neonatal disease will be~     assessed, including through retrospective immunological investigation of cord blood in~     neonates subsequently identified as having invasive GBS disease or other adverse perinatal~     outcomes, compared to those without.~      GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis),~     and these isolates will be compared to existing archived neonatal isolates from~     investigation of neonatal sepsis in KDH (Kilifi District Hospital). This is important so~     that we know the prevalent sub-types causing neonatal disease in Kenya, those which are~     carried by mothers, and therefore whether maternal GBS carriage correlates with a high risk~     of perinatal disease. GBS vaccines in development are type-specific and this will inform~     their use in sSA.~      Stillbirths will also be investigated, in individual cases, through additional detailed~     microbiological and other laboratory investigations to make an assessment of the~     contribution of GBS to stillbirths in Kenya.~   "
99324|NCT01757028|"~     Improving maternal and infant mortality are key priorities in Kenya and internationally.~     This study aims to establish a hospital-based surveillance system for pregnant women so that~     the contribution of risk factors (HIV and other infections, maternal nutrition, sepsis,~     malaria and anaemia) to maternal and infant morbidity and mortality can be accurately~     assessed. All mothers who are admitted to Kilifi District Hospital will be invited to enrol~     in the study. Routine clinical data from maternal admissions for delivery will be~     systematically collected using a standardised admissions procedure. Analysis will be carried~     out for the risk factor effects of HIV, maternal nutrition, malaria infection, bacterial~     infection, and anaemia on maternal and infant outcomes after adjusting for other factors~     (mode of delivery, age, and parity etc). Subsequent morbidity and survival of mothers and~     infants, and the later consequences to children's health will be monitored through the~     Kilifi epi-DSS. Samples for research purposes will be collected for detailed future studies~     of particular pathogens and risk factors, such as malaria parasite strain, bacterial species~     and HIV-induced immunological impairment. This will be the first prospective study in~     sub-Saharan Africa (sSA) to assess the effect of these risk factors on both maternal and~     infant health together, and that considers both short and long term outcomes. Information~     generated by the study will be used by the maternity department in a rolling audit that will~     help improve care. The study will therefore improve care of new mothers and infants~     attending the Kilifi District Hospital as well as informing health planning so that future~     interventions for maternal and child health are targeted more effectively.~   "
99325|NCT01757015|"~     This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.)~     via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status~     and is well tolerated compared to placebo in symptomatic COPD patients with moderate to~     severe airflow limitation who are already receiving maintenance therapy with inhaled~     fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.)~     via multi-dose dry powder inhaler (MDDPI).~   "
99326|NCT01757002|"~     The purpose of this study is to evaluate the Puff City web-based behavioral intervention of~     asthma management program in a clinical setting. This study also examines and evaluates the~     cost and efficiency of patient eligibility determination methods, patient recruitment, study~     monitoring (compliance with study regimen, participant retention and follow-up), and the~     collection of clinical endpoints.~   "
99327|NCT01756989|"~     The purpose of this study is to determine whether initial local irradiation with topotecan~     and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective~     in the treatment of pediatric diffuse brainstem tumor.~   "
99328|NCT01756976|"~     This study is intended to provide additional performance data of the OrthoPAT Advance in~     routine orthopedic surgery.~   "
99329|NCT01756963|"~     In addition to a genetic susceptibility, the immune system and the intestinal microbiota,~     diet is hypothesized to be an important factor in the onset and progression of Inflammatory~     Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute~     to targeted interventions improving disease burden and healthcare costs for these patients.~     However, well-designed studies exploring the role of diet in the development of~     exacerbations are hardly available.~      The investigators hypothesize that differences in dietary patterns affects the intestinal~     microbiota composition and thereby contributes to the development of exacerbations in IBD.~      Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence~     is unknown since simple noninvasive screening tools have not been validated for IBD. The~     investigators hypothesize that malnutrition is frequently present in IBD patients and~     associated with dietary intake and disease characteristics.~   "
99335|NCT01756885|"~     Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke~     following diagnosis and treatment. With medical advances in cancer care yielding a growing~     constituency of cancer survivors, addressing nicotine dependence in this population is a~     priority. While PHS guidelines recommend acute treatment durations with approved medications~     for tobacco use, extending the duration of treatment beyond the standard treatment duration~     significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to~     abstinence following a lapse. Varenicline may be particularly effective for cancer patients~     given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer~     patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks~     placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize~     that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed~     abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in~     the extended therapy group versus the standard therapy group, and there will be no~     significant differences between groups in terms of severe side effects, and 3) Improved~     affect and reduced cognitive impairment will mediate the effect of extended therapy on quit~     rates.~   "
99336|NCT01756872|"~     The purpose of this study is to find out more about tests used to estimate the number of~     eggs a woman has remaining in her ovaries (her 'ovarian reserve'). It is thought that women~     who have a greater number of eggs or ovarian reserve may have a better chance of successful~     in vitro Fertilisation (IVF) treatment than those who have a smaller number of eggs.~     Accurately predicting the likely outcomes of IVF would be of great benefit for counselling~     patients before they go through expensive and demanding treatments such as IVF and IVF with~     Intracytoplasmic sperm injection (IVFICSI).~      Over the past two decades, many endocrine and ultrasound markers have been designed and are~     now used as indicators of ovarian reserve. A number of screening tests are utilized to~     measure these markers, either by ultrasound scanning techniques or taking blood samples.~     However it is not yet known which, if any, best predict the outcome of IVF treatment. We~     would like to investigate these various measures of ovarian reserve to determine which are~     most accurate, particularly for predicting live birth rates, as up to now only poor to~     moderate quality evidence has been available for this outcome.~      This will be a prospective cohort study of 300 women who already intend to undergo~     IVF/IVF-ICSI treatment. Study participants will have one extra blood sample and ultrasound~     examination, for the purposes of measuring markers of their ovarian reserve, at the start of~     their IVF/IVFICSI treatment cycle. No other interventions will be required and their~     treatment cycle will not be affected by their participation in the study.~   "
99337|NCT01756859|"~     Death from chronic liver disease has doubled in the UK over the last decade. This is largely~     due to the rise in liver disease from excess alcohol consumption, obesity related fatty~     liver disease and hepatitis B & C infections. The current 'liver tests' only identify liver~     injury when the damage is at an advanced stage. They neither estimate the degree of injury~     accurately nor help judge prognosis. The complications from chronic liver disease result~     mainly from raised pressures within the liver. We currently measure this pressure by passing~     a long catheter through the jugular vein in the neck into the liver. This invasive test does~     carry a small yet significant risk of complications and is not available outside specialised~     liver centres. Raised pressure within the liver is also associated with changes in the~     microorganisms within the gut. This leads to increased infective complications among~     patients with liver cirrhosis.~      We aim to noninvasively measure the pressures within the liver using Magnetic Resonance~     Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver~     pressure measurements as part of their routine clinical assessment. The participants will~     attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also~     collect blood, urine and stool samples from them.~      The diagnostic accuracy of the quantitative MRI techniques will be validated against the~     pressures obtained via the invasive test. The quantitative MRI techniques will also~     correlated with biomarkers of liver injury obtained from blood and urine samples. The stool~     sample obtained will be used to characterise the gut microorganisms in these patients.~   "
99338|NCT01756846|"~     Aim of this study is to quantify the impact of the use of the HEART risk score on patient~     outcome and on costs in patients with chest pain presenting at the emergency room, as~     compared to not using the score.~   "
99339|NCT01756833|"~     The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by~     at least 40%) the increase in greatest transverse diameter of small abdominal aortic~     aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in~     comparison to a placebo-treated control group.~   "
99340|NCT01756820|"~     The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel~     Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®,~     Stryker) are equally effective and safe surgical options for the treatment of primary Carpal~     Tunnel Syndrome.~   "
99341|NCT01756807|"~     Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical~     Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic~     extension Study)~   "
99342|NCT01756794|"~     The purpose of this study is to validate a strategy of identification of patients for early~     liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is~     very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J~     Med 2011) that liver transplantation may be an option in very carefully selected patients~     who did not respond to medical treatment. This selection process deserves to be confirmed in~     a population of greater size. We hypothesized that patients selected with this process would~     have a same alcohol relapse rate after liver transplantation than patients transplanted for~     alcoholic cirrhosis and selected using a 6-month sobriety period~   "
99343|NCT01756781|"~     This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of~     midazolam in adult healthy women of non-childbearing potential when administered alone and~     when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be~     randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in~     treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period~     2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam~     in treatment period 1, and following a washout period of no less than 14 days they will~     receive midazolam alone in treatment period 2.~   "
99345|NCT01756755|"~     Despite maintaining adequate mean arterial pressure and central venous oxygen saturation,~     the mortality is still high in severe sepsis and septic shock. Previous studies have~     demonstrated that derangements in microvascular flow play a role in sepsis-induced multiple~     organ dysfunction and death. Lipopolysaccharide (LPS) or endotoxin is a specific ligand for~     Toll-like receptor 4 (TLR4), it can induce the following reactions including excessive~     immune and inflammatory responses , oxidative stress , capillary leakage, endothelial~     damage, impaired arteriolar and venular vasoregulation, and activation of the coagulation~     cascade 8. Subsequently, these reactions can lead to microcirculatory dysfunction. Polymyxin~     B adsorber hemoperfusion (PMX) have been proved to reduce mortality of severe sepsis and~     septic shock. Since 1994 to 2007, more than 60,000 patients have received this treatment. In~     a systematic review, the results show that PMX therapy was associated with significantly~     lower mortality risk (risk ratio, 0.53; 95% CI, 0.43 to 0.65). In a prospective,~     multicenter, randomized controlled trial (Early Use of Polymyxin B Hemoperfusion in~     Abdominal Sepsis [EUPHAS]), the results show that SOFA scores improved in the polymyxin B~     group, and 28-day mortality was 32% in the polymyxin B group and 53% in the conventional~     therapy group.~      The investigators hypothesize that polymyxin B hemoperfusion can decrease blood endotoxin~     level and reduce endotoxin-related microcirculatory dysfunction. The purpose of this~     prospective, multicenter, randomized, controlled, open study is to investigate the effect of~     polymyxin B hemoperfusion on the sublingual microcirculation in patient with proven or~     suspected gram-negative bacteria severe sepsis and septic shock. The mean arterial pressure,~     dose of vasopressors and inotropics, SOFA score, PaO2/FiO2 ratio, and 28-day mortality will~     be investigated.~   "
99346|NCT01756742|"~     Pleural effusion and the complexity of diagnosis and treatment make planning and delivering~     care challenging. Respiratory physiotherapy is recommended, and should be applied during the~     first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of~     a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a~     University Hospital.~   "
99347|NCT01756729|"~     This is a non-randomized, concurrent control study, designed to confirm that the efficacy of~     the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings~     following approval is comparable to that of BSC chemotherapy patients. The device is a~     portable, battery operated device that was approved for the treatment of adult patients (22~     years of age or older) with histologically-confirmed glioblastoma multiforme (GBM),~     following histologically- or radiologically-confirmed recurrence in the supra-tentorial~     region of the brain after receiving chemotherapy. The device is intended to be used as a~     monotherapy, and is intended as an alternative to standard medical therapy for GBM after~     surgical and radiation options have been exhausted.~   "
99348|NCT01756716|"~     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and~     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and~     Moderately Decreased GFR~   "
99349|NCT01756703|"~     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and~     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria~   "
99350|NCT01756690|"~     A certain molecule floating in the blood may represent a risk of lung injury after a~     transfusion. We are determining whether detection of this molecule on a simple blood~     clotting test will predict the development of lung injury due to transfusion in bleeding~     patients with chronic liver disease.~   "
99351|NCT01756664|"~     - The use of sunscreen on the first day after fractional ablative skin resurfacing may~     reduce the risk of post-inflammatory hyperpigmentation~   "
99352|NCT01756651|"~     The purpose of this study is to assess the safety and efficacy of intranasally-administrated~     fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of~     a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the~     urine, urinary complaints or any other problems with the urinary bladder). The current~     standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra~     to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is~     used to reduce pain that occurs during and after the above procedure.~   "
99353|NCT01756638|"~     The purpose of this study is to investigate safety and efficacy of abiraterone in~     participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not~     received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).~   "
99354|NCT01756625|"~     PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective~     cohort study and with independent investigators. The purpose is to compare PFS in real life~     with PFS clinical trials and to determine factors impacting efficacy and compliance to~     cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.~   "
99355|NCT01756612|"~     This prospective, multicenter, observational study will evaluate the impact of comorbidity~     factors on the hemoglobin level in participants with chronic kidney disease who are not on~     dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera).~     Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin~     beta treatment.~   "
99356|NCT01756599|"~     Regular advances in cancer treatment have dramatically improved the prognosis of children~     and adolescents with acute leukemia (AL), raising with a great acuity the problem of the~     late physical side effects, social integration, quality of life of the patients and their~     family as well as identification of the determinants of these outcomes. Large nationwide and~     international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the~     study of childhood cancers occurrence. In addition, the national registries (French,~     European) of childhood cancers are designed to evaluate incidence and mortality, but not to~     produce individual detailed data on the follow-up and outcome of these children. Answering~     these questions supposes a comprehensive multidisciplinary approach resting on prospective~     cohorts of cancer survivors, specifically exploring the outcome of these children. These~     cohorts allow to identify prognostic factors of the health condition and social integration,~     and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS),~     which remains the most important study, only concerns the North-American populations and~     rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004~     could answer some of these questions, but the representativeness and the size of the~     population (study initially limited to two areas PACA-Corsica and Lorraine) remain~     insufficient to study uncommon events. Similar approaches are conducted in Europe trough the~     broad collaborative Pancare network, to which the LEA program is associated.~   "
99357|NCT01756586|"~     Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on~     lower extremity blocks. The study would evaluate that point.~   "
99445|NCT01755429|"~     This protocol is intended to formally collect data on the treatment of aHUS with eculizumab~     in Japanese patients.~   "
99359|NCT01756560|"~     Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic~     nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using~     it in lower extremity blocks will prolong the analgesia to provide better outpatient pain~     relief after surgery at home.~   "
99360|NCT01756547|"~     Study to assess the efficacy and safety of oral potassium citrate on the Prevention of~     nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo~     controlled trial.~   "
99361|NCT01756534|"~     This single-blind prospective randomized study was designed to assess the efficacy and~     safety of the use of Surgicel® compared to the use of conventional surgical procedures~     (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery~   "
99362|NCT01756521|"~     The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in~     healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this~     study, moxifloxacin 400mg and 800mg will be used, to get information on effect of~     moxifloxacin on QT/QTc interval.~   "
99363|NCT01756508|"~     Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.~   "
99364|NCT01756495|"~     This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy~     adult subjects. The purpose of this study is to characterize the effect of orally~     administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac~     repolarization as measured by the corrected QT interval (QTc) duration, compared with~     placebo and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a~     mild QTc interval prolongation; therefore, it will serve as a positive control to validate~     the ability of this study to detect a change in the QTc interval. All subjects will~     participate in 4 study periods separated by a minimum washout period of 5 days. Each subject~     will receive one of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5~     days, B = Losmapimod 20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D =~     Losmapimod matched placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study~     periods in a randomized, cross-over fashion. Subjects will be assigned to one of four~     treatment sequences following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit~     will occur 10 to 14 days after end of Period 4~   "
99365|NCT01756482|"~     This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a~     strain of Respiratory Syncytial Virus.~   "
99366|NCT01756469|"~     The main study objective is to investigate whether female sex workers (FSWs) at drop-in~     centers in Mombasa, Kenya, who report harmful or hazardous alcohol intake and participate in~     a brief alcohol intervention (vs. those who participate in a nutrition intervention in the~     control group), will reduce their alcohol use and incidence of STIs, HIV, and sexual~     violence, as well as increase their condom use.~   "
99367|NCT01756456|"~     This study is aimed at assessing the safety and the efficacy of two dose regimens of~     recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for~     inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)~     neurotrophic keratitis~   "
99368|NCT01756443|"~     Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of~     ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a~     better safety profile as the injection of local anaesthetic is performed under direct~     vision. This has allowed a reduction of the amount of local anaesthetic injected as compared~     to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with~     saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various~     combinations of local anaesthetics have been used to provide optimal blockade . A mixture of~     lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset~     of blockade, but of a consistently shorter duration compared to a long acting local~     anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and~     bupivacaine provides similar onset but a longer duration of sensory block compared to the~     same dose and volume of local anaesthetic mixed in advance.~   "
99369|NCT01756430|"~     The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus~     Carvedilol IR in Patients With Essential Hypertension~   "
99370|NCT01756417|"~     The purpose of this study is to investigate whether there is a drug-drug interaction between~     multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety~     and tolerability of canagliflozin will also be assessed.~   "
99371|NCT01756404|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of~     canagliflozin (JNJ-28431754) in healthy obese volunteers.~   "
99372|NCT01756391|"~     Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14~     million missed school days per year, and is the number one cause of school absences in~     America. Elementary school children spend 6 to 10 hours a day in school, and most of that~     time is spent in one classroom. The goals of this project are to provide an understanding of~     exposure risk factors specific to the classroom. This is critical, because the classroom~     environment could potentially be considered as an effective target for prevention of~     inner-city asthma morbidity by reducing exposures to many symptomatic children through an~     intervention in the school classrooms.~   "
99373|NCT01756378|"~     we tested the effect of adding the mobilization with movement to the traditional physical~     therapy program on pain, ROM and functional disability in patients with knee OA.~      study hypothesis: there will be no significant difference between traditional physical~     therapy program and the mobilization with movement plus the traditional physical therapy~     program on pain, ROM and functional disability in patients with knee OA~   "
99374|NCT01756365|"~     The study  Autologous cultured corneal epithelium (CECA) for the treatment of unilateral~     corneal lesions associated with limbal stem cell deficiency is the first clinical trial of~     this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives~     to produce a reconstructed tissue with the therapeutical aim of treatment of unilateral~     limbal stem cell deficiency (only one eye is affected by the limbal stem cell deficiency).~     The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the~     CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.~   "
110502|NCT01609855|"~     The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at~     time of caecal intubation, increases the adenoma detection rate.~   "
99375|NCT01756352|"~     Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET~     will predict durable benefit in patients receiving anti-angiogenic benefit for presumed~     recurrent GBM (i.e. progression-free survival and overall survival). We have defined one~     primary specific aim, for which we expect to obtain definitive results, and two secondary~     aims, under which we plan to generate preliminary data to support a future, larger project.~   "
99376|NCT01756339|"~     This study will evaluate the safety and efficacy of an experimental antibiotic,~     solithromycin, in the treatment of adult patients with community-acquired pneumonia.~   "
99377|NCT01756326|"~     Fracture healing is a complex physiological process caused by interaction of cellular~     elements, cytokines and signaling proteins, which results in the formation of new bone~     (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other~     factors, 10% of all fractures will eventually fail to unite.~      Non-union fractures are defined as fractures that are at least six to nine months old and in~     which there have been no signs of healing for the last three months. Various causes have~     been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions,~     including poor fracture stabilization, local infection and failure of the osteoblastic cells~     to multiply. Currently the treatment of choice for non-unions, particularly atrophic~     non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing,~     plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces~     good results but requires an invasive surgery of several hours under general anesthesia and~     a few days of hospitalization. Because of this, major complications have been reported in up~     to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).~      This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary~     population of autologous osteoblastic cells, in the treatment of hypotrophic non-union~     fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority~     design.~   "
99378|NCT01756313|"~     The objectives of this study is to investigate if pre-treating the skin with an ablative~     fractional laser that creates small micropores in the skin:~        1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.~        2. Decreases the required incubation time of MAL when performing photo dynamic therapy.~   "
99379|NCT01756300|"~     The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility~     study to evaluate the safety and effectiveness of the investigational multi-electrode~     ablation catheter and integrated ablation system to treat resistant hypertension.~   "
99380|NCT01756287|"~     To assess whether Chinese ocular exercise is effective in altering distant and near visual~     acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the~     possibility of slowing myopia progression in teenager through a weak but long-term effect.~   "
99381|NCT01756274|"~     The purpose of this study was to evaluate the performance of three Bayer Blood Glucose~     Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were~     'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a~     tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with~     capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000~     instrument).~   "
99382|NCT01756261|"~     The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL).~     The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of~     National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at~     baseline and at the 6 and 12 months after start of EYLEA treatment.~   "
99383|NCT01756248|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received EYLEA for Age-Related~     Macular Degeneration (AMD).~      The objective of this study is to assess safety and effectiveness of EYLEA using in real~     clinical practice.~      A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational~     period. An annual follow-up survey will be conducted for 5 years at the longest after~     standard observational period.~   "
99384|NCT01756235|"~     Physical activity has positive impacts upon pain, disease activity and functional status in~     patients with rheumatoid arthritis (RA). Additionally, it may decrease the augmented~     cardiovascular risk in this patient population. Despite these apparent benefits of physical~     activity in RA, very little is known about physical activity in patients on biologic~     therapy. It could be hypothesized that improved control of RA signs and symptoms, better~     physical function and inhibition of structural damage all make the ground for an increased~     physical activity in patients treated with biologic agents after inadequate response to~     conventional Disease Modifying Antirheumatic Drugs (DMARDs).~      Adalimumab is the biologic agent which demonstrated unsurpassed efficacy in improving~     physical function, as well as short- and long-term work productivity outcomes in patients~     with RA. Therefore, adalimumab is a good candidate biologic agent to evaluate the impact on~     physical activity in RA.~   "
99385|NCT01756222|"~     The purpose of this registry is to gather information on patients with bicuspid aortic valve~     disease.~   "
99386|NCT01756209|"~     Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or~     acetaminophen for the acute treatment of primary migraine in children in or out prophylactic~     treatment with magnesium.~      Methods: The study had been approved by the Researchers Ethics Committee of the~     Pugliese-Ciaccio Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and~     the children ranging from the ages of 5 to 18 years with at least four attack/month of~     primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain~     intensity at the moment of admission to the study (start of the study) and every month up to~     18 months later (end of the study).~   "
99387|NCT01756196|"~     Many systemic reactions occur commonly after spinal steroid injections, especially in~     patients, and may be associated with underlying disease, such as hypertension and diabetes~     mellitus, as well as steroid dose and repetition of spinal steroid injection.~   "
99388|NCT01756183|"~     Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the~     Patients with Unresectable Gastric Cancer~   "
99389|NCT01756170|"~     This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II~     b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater~     toxicities but similar survival rate as those treated by radiotherapy alone.~   "
110503|NCT01609842|"~     Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure~     performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant~     therapy following PCI with stent placement and is generally recommended for up to 1 year~     following the procedure. Despite the evidence supporting clopidogrel use, studies both~     outside and within the VA suggest that poor adherence to clopidogrel is common. However,~     prior interventions targeting non-adherence have not specifically focused on clopidogrel~     adherence among PCI patients.~      There are many potential reasons for early clopidogrel discontinuation that involve patient~     and healthcare system factors. Patients reported the following reasons for discontinuing~     clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding~     the intended treatment duration; 2) conflicting recommendations about intended duration; 3)~     cost of the medication; and 4) patients' own decision to stop. In contrast, patients who~     continued to take clopidogrel reported the following as helpful: 1) communication such as~     letters from their physician; and 2) receiving specific instructions on clopidogrel use.~     These findings suggest that there are specific interventions that can be implemented to~     improve clopidogrel adherence.~      Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists~     and use interactive voice response (IVR) technology have improved medication adherence. IVR~     technology is a computer-based telephone system which initiates calls, receives calls,~     provides information, and collects data from users. IVR is currently a mainstay in the VA~     where patients frequently interact with these automated systems to get clinic appointments~     and/or refill prescriptions. IVR as part of multi-modal interventions have been well~     received by patients, increased adherence to medications (e.g., statins), and improved~     clinical outcomes (e.g., blood pressure, diabetes symptoms, health status). In addition, the~     investigators have successfully used IVR as part of a multi-modal, multi-site intervention~     including pharmacists to improve blood pressure levels among hypertensive patients.~     Accordingly, the investigators have designed the intervention to improve clopidogrel~     adherence that builds on the investigators' prior work and other successful adherence~     interventions from the literature.~      The investigators propose a hybrid effectiveness-implementation study of a multi-faceted~     intervention to improve clopidogrel adherence at VA PCI centers. The investigators will use~     the VA's Cardiovascular Assessment Reporting and Tracking (CART-CL), a uniform cath lab~     procedure reporting tool at all VA cath labs. The intervention consists of 4 components: a)~     an alert from CART-CL will be sent to an inpatient pharmacist prior to discharge that a~     patient has received a stent; b) a pharmacist will bring clopidogrel to the patient's~     bedside prior to hospital discharge as well as educate the patient on the importance of and~     adherence to clopidogrel following PCI; c) interactive voice response (IVR) calls will be~     made to patients prior to the time of clopidogrel refill to remind patients and to~     facilitate refills during follow-up; and d) a Patient Aligned Care Team (PACT) member will~     contact patients who delay filling clopidogrel.~   "
99391|NCT01756144|"~     When there is a bone defect, bone transport is used to bridge the defect. Frequently, the~     bone in the docking site (where the transported bone comes together) doesn't heal.~      The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing,~     in order to find new techniques to treat non-union of long bones.~      The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous~     bone grafting in stimulating bone healing in the docking site.~   "
99392|NCT01756131|"~     A single dose escalation study to determine the safety, tolerability, and pharmacokinetic~     profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral~     (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and~     follow-up evaluations for a minimum of 12 weeks following the injection.~   "
99393|NCT01756118|"~     Primary objectives:~        -  To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D)~          of BEZ235 when administered twice daily (BID) as a single agent in patients with~          relapsed or refractory acute leukemia~        -  To determine the dose-limiting toxicity (DLT)~      Secondary objectives:~        -  Assess the safety and tolerability of daily oral administration of BEZ235 with a BID~          schedule~        -  To describe preliminary anti-leukemic activity of BEZ235 in patients with acute~          leukemia~        -  To correlate changes in pharmacodynamic biomarkers with basic pharmacokinetic data~      Exploratory objectives:~        -  To assess pre-treatment phosphatidylinositol 3-kinase (PI3K) pathway-related genes in~          blast cells and all other malignant cells derived from blood or bone marrow.~        -  To assess the pharmacodynamic changes in components of the PI3K-protein kinase B~          (AKT)-mTOR pathway in bone marrow following treatment as potential predictive~          biomarkers of pharmacodynamic (PD) activity of BEZ235 in association with clinical~          responses.~        -  To identify potential resistance mechanisms and biomarkers that may correlate with~          efficacy and response from blood and bone marrow samples pre-and post-treatment in case~          of resistance~   "
99394|NCT01756105|"~     Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading~     to fetal and maternal complications which may be prevented by reaching very strict glycaemia~     targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence~     is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because~     criteria of screening have been strengthened after the results of last studies. Usual~     treatment is diet and in case of failure insulin therapy with multiple injections which may~     lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some~     studies have shown the comparable effect of metformin and insulin in about 50% of GD obese~     patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and~     fetus and baby of metformin. In case of metformin failure, insulin will be added in order to~     obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby~     umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress~     compared between insulin and metformin alone treated patients.~   "
99395|NCT01756092|"~     The investigators will assess changes in breast appearance, graft retention and quality of~     life over one year in patients who have received direct autologous adipose tissue injection~     for the treatment of objectionable post-surgical breast deformities. These patients have~     undergone the resection of breast tissue to treat either benign or malignant breast disease.~   "
99396|NCT01756079|"~     This study is being done to find out if the addition of boceprevir to standard of care (SOC)~     treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for~     participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not~     successfully treated by previous SOC. All participants will receive treatment with SOC alone~     for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional~     weeks of combined treatment.~   "
99397|NCT01756066|"~     To test the uptake of four different cost sharing discounts for enrolling in the Weight~     Watchers weight loss program as well as outcomes (program attendance and weight loss) over~     12 months.~   "
99398|NCT01756053|"~     This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089~     (an experimental medication not approved by the FDA) when administered as 40mg oral once~     daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive~     deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit~     attempt (~4 days). The key cognitive domains include: working memory, sustained attention,~     and response inhibition.~   "
99399|NCT01756040|"~     Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency~     characterized by increased intestinal permeability, affects approximately 7 to 10% of~     infants <1500 g birthweight, and typically occurs within 7 to 14 days of birth. Mortality is~     as high as 30-50%. Prematurity is the greatest risk factor for the development of NEC due to~     the physiological immaturity of the gastrointestinal tract and altered or abnormal gut~     microbiota. Several studies have demonstrated that the initiation of an intense systemic and~     local inflammatory cascade leads to intestinal necrosis. The human intestine is lined by a~     single layer of cells exquisitely responsive to multiple stimuli and is populated by a~     complex climax community of microbial partners. Under normal circumstances, these intestinal~     cells form a tight but selective barrier to friends and foes: microbes and most~     environmental substances are held at bay, but nutrients are absorbed efficiently. Epithelial~     barrier integrity is itself dynamic and matures over time starting soon after birth, though~     the mechanisms regulating dynamic permeability are poorly understood. Low birth weight,~     prematurity, and early postnatal age are associated with a leaky gut. Although intestinal~     permeability is higher at birth in preterm than term infants, there is usually rapid~     maturation of the intestinal barrier over the first few days of life in both populations.~     The investigators hypothesize that increased levels of measures of intestinal permeability~     (serum zonulin, urine lactulose/rhamnose (LA/Rh), and fecal alpha1- antitrypsin will~     identify infants at high risk for NEC. The purpose of the study is to determine whether~     measurement of intestinal permeability in serum will correlate with other markers of~     intestinal barrier leakiness measured in urine (LA/Rh) and stool (alpha-1 antitrypsin. If~     there is good correlation, then zonulin or serum rhamnose may be a useful measure to~     identify preterm babies at risk for NEC.~   "
99400|NCT01756027|"~     Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy~     treatments on the cheeks, depending on their assigned study group. Follow-up visits will~     occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60~     min post-treatment, and at each follow-up visit.~   "
99401|NCT01756014|"~     The investigators will evaluate the determinants of cerebral impairment in patients with~     non-ischemic heart failure compared to controls, and its relation to cognitive function.~     They hypothesize that patients with heart failure have impaired brain perfusion and~     hemodynamic factors are associated with cognitive dysfunction.~   "
99402|NCT01756001|"~     This randomized control trial will explore interventions to promote medication adherence~     using a novel electronic device that can track daily pill use. 500 subjects will be~     randomized into 4 arms of the experiment. In addition to a control arm, our three arms will~     be: reminders, financial incentives, and reminders and financial incentives.~   "
99403|NCT01755988|"~     The number of people with heart failure is increasing in the western world. Mainly due to~     better treatment of myocardial infarctions and ageing of the population. The amount of~     health care workers is unfortunately not increasing. We want to investigate how two~     electronic devices (a website and an interactive web-based platform) influence the~     self-care, quality of life, hospitalizations and mortality by delivering care from a~     distance. We also want to investigate if a higher quality of care is delivered despite of~     less frequent visits to a nurse and/or doctor. The study takes place in the Netherlands and~     is a randomized trial. Patients with heart failure, registered by an outpatient heart~     failure clinic or general practitioner can take part. They will be randomized to 3 groups:~     group 1 receives standard care, group 2 receives standard care with the website, group 3~     receives an adjusted care pathway, with both the website and the interactive web-based~     platform connected to a telemonitoring system. In this group all routine consultations with~     heart failure nurses and general practitioner will be substituted by this device.~   "
99404|NCT01755975|"~     The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well~     or they may only work for a short period of time. This is why new treatments are being~     tested.~      This study will test a new combination of two drugs that are already approved by the Food~     and Drug Administration for treatment of certain kinds of blood cancers. These drugs are~     romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma~     or multiple myeloma. However, while these drugs are routinely used alone, this is the first~     time they will be tested together. The mechanism of action of both drugs is not well~     understood but both have been shown to to be effective by themselves in lymphoma and~     multiple myeloma.~   "
99405|NCT01755962|"~     This project is prompted by the urgent public health need to identify novel strategies to~     prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of~     CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern.~     Therefore, finding optimal intervention strategies to combat these growing epidemics is~     imperative.~   "
99406|NCT01755949|"~     Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the~     rise in CRP which occurs following atrial fibrillation ablation~   "
99407|NCT01755936|"~     Aortic stenosis is the most common adult valvular heart disease in the western world. Heart~     failure and sudden cardiac death are complications associated with aortic stenosis. In~     symptomatic individuals, valve replacement is often the only effective treatment. However,~     there are no good markers to identify patients who may benefit from early surgery before~     symptoms developed. The purpose of the study is to test the hypothesis that the presence~     heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome~     in patients with aortic stenosis, and thus may be helpful in identifying patients for early~     valve replacement.~   "
99408|NCT01755923|"~     Gefitinib, the first EGFR-tyrosine kinase inhibitor (TKI) in the world was examined as~     monotherapy in two phase Ⅱ studies called IDEAL trials. Response rate with doses of 250mg~     and 500mg/day were similar, ranging from 10% to 18%. Posterior analysis demonstrated that~     patients with EGFR mutation had an improved response rate (RR) to gefitinib compared to~     wild-type patients (46% versus 10%). The early trials that evaluated EGFR-TKIs for the~     second- and third-line settings of advanced NSCLC did not select patients on the basis of~     any EGFR marker. The IEESSA Survival Evaluation in Lung Cancer (ISEL) trial evaluated the~     role of second-line gefitinib 250mg/day in 1692 patients with advanced NSCLC. Patients with~     EGFR mutations had higher RR than patients without (37.5% versus 2.6%). From the above~     results, the response rate in patients without EGFR gene mutation was obviously different~     (10% versus 2.6%). The methods used for detecting EGFR gene mutation was different, which~     might contribute to the difference of response rates. In IDEAL trial, EGFR gene mutation was~     detected by sequencing. But in ISEL trial, EGFR gene mutation was detected by ARMS. As we~     know, ARMS was more sensitive than sequencing in detecting EGFR gene mutation. That is to~     say, in IDEAL trials some EGFR mutant patients were misdiagnosed as wild-type patients, so~     the response rate was higher. Recently, Wu Yi-Long et al reported that relative abundance of~     EGFR mutations predicted benefit form gefitinib treatment for advanced non small cell lung~     cancer. The study cohort was all Chinese. In this study, the objective response rate in~     patients without EGFR mutation detected by ARMS was 16.1%, which was significantly higher~     than the response rate of docetaxel. But in 2012 American society of clinical oncology~     (ASCO) annual meeting, the Tailor study in which Italian NSCLC patients were enrolled~     demonstrated a clear superiority of docetaxel over erlotinib as second line treatment for~     patients without EGFR mutations in exons 19 or 21. So we wonder if the racial difference is~     the determinant factor. So the purpose of this trial is to compare the efficacy and safety~     of gefitinib with docetaxel as second-line therapy for advanced or metastatic Chinese NSCLC~     patients with wild-type EGFR.~   "
99409|NCT01755910|"~     The Left thoracic paravertebral block have a different effect on heart's autonomic nervous~     system, as measured with Heart Rate Variability, compared to Right interscalene block~   "
99410|NCT01755897|"~     We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant~     chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival~     (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical~     cancer patients with risk factors.~   "
99411|NCT01755884|"~     The aim of the study is to induce tolerance to wheat in wheat allergic children via oral~     desensitization therapy. The hypothesis is that oral administration of wheat with increasing~     dosing will increase the individual threshold for allergic reactivity to wheat protein (i.e.~     desensitization) and even result in no reactivity (i.e. full tolerance). Along with this,~     the risk for severe allergic reaction to wheat protein is minimized and the diet of patients~     can partly or completely be normalized. In addition to clinical measures, the immunological~     mechanisms of desensitization therapy are studied in detail at cellular and molecular level.~   "
99412|NCT01755871|"~     The purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of~     action of fingolimod in patients with Relapsing remitting multiple Sclerosis to collect data~     on biomarkers after initiation of fingolimod treatment.~   "
99413|NCT01755858|"~     The primary objective of this trial is to assess the effects of Bendavia on renal blood flow~     and renal function in atherosclerotic renal artery stenosis (ARAS), compared with placebo in~     patients with ARAS who receive one dose of study drug infused 30 minutes before and 3 hours~     after percutaneous transluminal angioplasty of the renal artery (PTRA).~   "
99414|NCT01755845|"~     The purpose of this study is to determine the efficacy and safety of consolidation~     chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical~     hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage~     cervical cancer.~   "
99416|NCT01755819|"~     Background:~      Failure of graft incorporation and tunnel widening (TW) after anterior cruciate ligament~     (ACL) reconstruction has been frequently reported in the literature. The etiology of TW is~     still not fully understood.~      Patients and Methods:~      This is a prospective randomized study including 60 patients, conducted in a Level I trauma~     center in Innsbruck, Austria. The study protocol was approved by the hospital ethics~     committee. This study is planned and conducted following the Consolidated Standards on~     Reporting Trials (CONSORT) guidelines. Aperture fixation is performed using BioComposite~     interference screws (Arthrex, Naples, FL). Extracortical fixation is performed using the ACL~     Tightrope (Arthrex, Naples, FL). TW is measured on CT scan postoperative, after 6 and 24~     months. Clinical outcome is determined at 1, 2 after reconstruction, IKDC with KOOS~     Knee-related QoL subscale, Lysholm, Tegner Activity scores, hop tests and KT-1000~     measurements are performed.~      Hypothesis:~      The purpose of this randomized controlled trail is to determine the influence of two~     different fixation methods on TW and clinical outcome after anatomic ACL reconstruction~     using hamstring graft in young and active patients.~   "
99417|NCT01755806|"~     This study seeks to compare aortic dimension changes during cardiac cycle in patients with~     and without aortic valve calcification and to evaluate its correlation with aortic valve~     calcium score in former group.~   "
99418|NCT01755780|"~     The Left interscalene block has a different effect on heart's autonomic nervous system,~     compared to Right interscalene block. This effect is evident on the occurrence of~     bradycardia and hypotension during shoulder surgery in the beach chair position~   "
99419|NCT01755767|"~     The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating~     patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already~     been treated once with another therapy.~   "
99420|NCT01755754|"~     A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to~     assess the functionality of female condoms with a silicone elastomer vaginal ring.~   "
99421|NCT01755741|"~     This trial will assess the potential impact of a vaginal ring on condom use by comparing the~     performance (total clinical failure, clinical slippage, and clinical breakage) of a standard~     male lubricated latex condom when the female partner is wearing the vaginal ring and when~     the female partner is not wearing the vaginal ring.~   "
99422|NCT01755728|"~     There is a report that acetaminophen may have a role in pharmacological closure of PDA~     (Patent arterial duct) in preterm infants.~      The investigators conducted this open label non randomized and non control study to try to~     support that report.~   "
99423|NCT01755715|"~     The main objective of this study is to compare, in a randomised, controlled and prospective~     fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days)~     versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception~     one year after abortion.~   "
99424|NCT01755702|"~     This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and~     an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.~   "
99425|NCT01755689|"~     The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'~     meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to~     MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with~     Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix~     co-administered with Boostrix.~   "
99426|NCT01755676|"~     The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of~     Obesity in adults.~   "
99427|NCT01755663|"~     Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.~   "
99428|NCT01755650|"~     The purpose of this study is to investigate the safety and potential effectiveness of the~     imaging compound 18F FPM for finding sites of malignancies.~   "
99429|NCT01755637|"~     The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole~     tablet formulations manufactured under the different granulation processes in healthy~     Chinese adult males.~   "
99430|NCT01755624|"~     The study is a prospective, randomly controlled phase II trial, designed to test the~     efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the~     treatment of NSCLC patients with controlled systemic disease, following optimal standard~     local treatment for 1-5 brain metastases (BM). The device is an experimental, portable,~     battery operated device for chronic administration of alternating electric fields (termed~     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated~     electrode arrays.~   "
99431|NCT01755611|"~     The aim of the study is to compare the bioavailability of two medications containing 100 mg~     of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a~     registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a~     registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is~     randomized, open, cross-over with two single administrations with two periods and two~     sequences with a wash-out period of 7 days between the periods. Subjects in the study will~     be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33,~     0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0~     hours after medication administration in each period. Plasma minocycline levels will be~     determined by HPLC method with UV detection with previously validated method. Minocycline~     concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3~     software. The log transformed pharmacokinetics parameters of test and reference medications~     will be compared calculating ratios and 90% confidence intervals. Any adverse event will be~     reported.~   "
99432|NCT01755598|"~     The purpose of this study is to evaluate the protective efficacy of two doses of GSK~     Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy~     will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because~     pulmonary TB occurs frequently in these countries and age range. In addition, the safety and~     immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of~     volunteers.~   "
99467|NCT01755143|"~     The purpose of this study is to test the safety and effectiveness of the Medtronic~     CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI~     pacemaker and undergo an MRI scan.~   "
99433|NCT01755585|"~     Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell~     proliferation, induce cell death and suppress tumor growth. To improve the treatment~     outcome, in terms of both locoregional control and survival, the concurrent use of~     chemotherapy during radiation therapy (CCRT) is now the standard treatment for various~     malignancies, especially locally advanced cancers. Among the drugs used to enhance RT~     effect, 5-fluorouracil (5-FU) is one of the most commonly used chemotherapeutic agents of~     CCRT.~      In the past, RT was solely used as a local treatment and its effect was estimated by local~     effect model. However, growing evidence shows that irradiation has direct DNA~     damage-dependent effects as well as sending signals to neighboring cells. Recently, we~     reported that abdominal irradiation could significantly modulate the systemic~     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the~     daily treatment dose for target treatment in an experimental rat model. Additionally, the~     results from a clinical investigation showed that colorectal cancer patients with lower AUC~     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these~     lines of evidence support the importance and necessity to search for the mediators~     responsible for the unexpected effect of local RT on systemic pharmacokinetics of~     chemotherapeutic agents, such as 5-FU.~      In the present study, the investigators investigated whether the phenomena and mechanism of~     RT-PK is a fact for different anticancer drugs in human.~   "
99434|NCT01755572|"~     Purpose:~      The purpose of this study is to further study the mechanism by which liraglutide, a~     relatively new anti-hyperglycemic medication, might lower blood pressure in patients with~     Type 2 diabetes and high blood pressure.~   "
99435|NCT01755559|"~     Study treatments:~        -  Artemether-lumefantrine~        -  Artesunate-amodiaquine~        -  Dihydroartemisinin-piperaquine~      Location:~      Maradi, Niger~      Principal Objective:~      To measure the clinical and parasitological efficacy of the three artemisinin combination~     therapies over a period of 42 days from the start of treatment and with polymerase chain~     reaction assay (PCR) adjustment.~      Secondary objectives:~        -  To determine the blood concentration of the non-artemisinin component of the treatment~          (lumefantrine, desethylamodiaquine or piperaquine) at day 7~        -  To assess the incidence of adverse events during the follow-up period;~        -  To measure speed of parasite clearance~      Methods:~      In vivo non comparative study as for WHO standardised protocol. The study also measure the~     concentration of the non-artemisinin component.~      Target population:~      Children under 5 years of age consulting the integrated health centres of Andoumé and~     Dix-sept portes in Maradi.~      Sample size:~      221 patients per study treatment; 663 patients in total.~      Treatment allocation:~      Random.~      Outcomes:~        -  Early treatment failure,~        -  Late clinical failure,~        -  Late parasitological failure,~        -  Adequate clinical and parasitological response.~      Analysis:~        -  Cumulative success or failure rate (Kaplan-Meier analysis).~        -  Proportions of early treatment failures, late clinical failures, late parasitological~          failures, and adequate clinical and parasitological response (called also Per-protocol~          analysis).~   "
99436|NCT01755546|"~     The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic~     efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous~     around-the-clock opioid analgesia for an extended period of time.~   "
99437|NCT01755533|"~     The goals of this study are to develop a middle school substance use prevention curriculum~     for underserved rural youth and evaluate its efficacy compared to the existing,~     multicultural curriculum. In addition, we are studying how the curricula get taught by the~     teachers.~      Hypothesis 1: When compared to students in the control condition, students in the treatment~     conditions will report less substance use, more conservative norms, less positive~     expectations about substance use outcomes, and better life and communication skills.~      Hypothesis 2: When compared to students in the control condition, students in the researcher~     adaptation condition will report less substance use, more conservative norms, less positive~     expectations, and better life and communication skills.~      Hypothesis 3: When compared to students in the control condition, students in the teacher~     adaptation condition will report less substance use, more conservative norms, less positive~     expectations, and better life and communication skills.~      Hypothesis 4: Researcher adaptation will have a greater impact on substance use, norms, and~     expectations than teacher adaptation.~   "
99438|NCT01755520|"~     The primary objective of this study ist to test the hypothesis that ticagrelor is superior~     to Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in~     patients undergoing artery bypass operation.~      The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial~     infarction, recurent revascularisation, and stroke at twelve month after coronary artery~     bypass operation.~   "
99439|NCT01755507|"~     Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of~     Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of~     PSC.~   "
99440|NCT01755494|"~     The primary objective of this study is to assess the pharmacokinetic parameters of~     saxagliptin and metformin in healthy male Chinese subjects.~   "
99441|NCT01755481|"~     To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei~     strain F19 or Whey Protein Concentrate.~   "
99442|NCT01755468|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a pilot randomized controlled trial to determine whether~     intermittent intensive insulin therapy is an effective therapeutic strategy that can~     preserve pancreatic beta-cell function and maintain glycemic control early in the course of~     type 2 diabetes.~   "
99443|NCT01755455|"~     This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks~     increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic~     anemia.~   "
99444|NCT01755442|"~     This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to~     evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in~     subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone,~     metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione~     (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.~   "
99446|NCT01755416|"~     Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control~     system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic~     excursions than insulin mono-therapy.~      Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition~     of Liraglutide compared to insulin mono-therapy.~      Study Design: This is a randomized open labeled crossover design trial comparing adjuvant~     Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for~     insulin delivery.~   "
99447|NCT01755403|"~     o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic~     Chagas Disease to get information to optimize drug doses.~   "
99448|NCT01755390|"~     Primary Objective:~      - To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of~     XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4~     consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each~     5-week treatment cycle).~      Secondary Objectives :~        -  To define the safety profile of the drug~        -  To establish the recommended dose and time interval for future Phase II trials~        -  To determine the pharmacokinetic (PK) profile of XRP6258 in man~        -  To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose~          (following Protocol Amendment No. 2)~        -  To look for evidence of antitumor activity~   "
99449|NCT01755377|"~     Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic~     countries because migration of people infected with T. cruzi. Current methods for diagnosis~     of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce~     severe side-effects, and their effectiveness cannot be properly evaluated. Reliable~     biomarkers for prognosis, early diagnosis and effectiveness of treatment will be~     investigated.~   "
99450|NCT01755364|"~     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy~     subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive~     one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged~     equal to or over 3 years old and less than 9 years old will received two doses of vaccine~     (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days).~     Safety outcomes included immediate reactions at the time of vaccination, solicited local and~     systemic reactions within 7 days after each vaccination, unsolicited adverse events observed~     since first vaccination to 28 days after the last dose of vaccination, and serious adverse~     events during the observation. Sera prepared from blood samples will be collected from each~     subject immediately prior to, and 4 weeks after each vaccination. Anti-hemagglutinin (HA)~     antibody titers will be determined using the WHO hemagglutination inhibition reference~     technique. The central laboratory who is responsible for antibody titrations will not be~     aware of the background of blood samples (e.g., pre- or post-serum), it is also called~     observer-blinded. All subjects will be followed, either by clinical visit or by telephone~     contact, for 8 weeks after the last vaccination for safety reasons.~   "
99451|NCT01755351|"~     An effective treatment adherence was a key to make the treatment success, some reports had~     shown that psychologicl factors impact patients adherence seriously,however, in China, the~     researches were only limited to depression and diabetes,diabetes distress was neglected.~     Some western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we~     hypothesized that: 1.perhaps our present depression-oriented health education was inadequate~     to promote patients' adherence, diabetes distress might played a more important part than~     depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes~     distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and~     depresion was conducted.~      Objectives: to explore the relationship of diabetes-related distress and depression，and to~     compare the influence of diabetes distress and depression on treatment adherence in Chinese~     type 2 diabetes .~      Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class~     hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised~     Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.~   "
99452|NCT01755338|"~     The purpose of this study is to investigate if methylprednisolone is effective in reducing~     the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.~   "
99453|NCT01755325|"~     It is an open-label, randomized, double blind, placebo-controlled parallel-group,~     multi-center study to evaluate the efficacy and safety of Compound realgar formula~     Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone~     in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous~     leukemia in the chronic phase (CML-CP).~   "
99454|NCT01755312|"~     This study to evaluates how a med reminder affects the patient's ability to take medications~     as prescribed~   "
99455|NCT01755299|"~     The line of 5-hour Energy® products are available over-the-counter as energy supplements.~     The appeal of these products involves ease of use, low caloric value, and the absence of~     sugar to prevent a crash later in the day. The definitive efficacy and potency of the~     products is unknown due to the lack of evidence-based clinical reports. It is suspected that~     the efficacy related to these products is due to the caffeine content, which was reported as~     138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this~     randomized, double-blind, placebo controlled, four way crossover study is to evaluate the~     efficacy of 5-hour Energy®, 5-Hour Energy Decaf®, caffeine, and placebo for perceived~     energy and wakefulness.~   "
99456|NCT01755286|"~     The purpose of this study is to describe the safety and tolerability of two dose levels of~     OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with~     bilateral middle ear effusion who require tympanostomy tube placement.~   "
99468|NCT01755130|"~     The goal of this clinical research study is to learn if an imaging device called the Laser~     Optoacoustic and Ultrasonic Imaging System Assembly (LOUISA-3D) is effective in detecting~     and monitoring changes in breast tumors.~   "
99469|NCT01755117|"~     Total Knee Replacement can be performed under the combination of posterior lumbar plexus~     block plus sciatic nerve block. The investigators can have the same outcome by performing~     instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically~     under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve~     block.~   "
110794|NCT01606033|"~     This study aims to assess anxiety/depression and life quality of patients included in~     clinical trials versus patients treated in a standard way.~   "
99457|NCT01755273|"~     Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas,~     proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was~     followed by complicated reconstructions. Therefore, PD causes change of physiological~     functions, containing insufficiency of exocrine and endocrine pancreatic function,~     malabsorption of nutrients, impairment of gut peristalsis, and hepatic steatosis . On the~     other hand, DM may also resolve after PD in cases with pancreatic ductal adenocarcinoma.~     From the study of bariatric operation, resolution of DM may occur even before body weight~     loss. Postulated mechanism of resolution of DM after bariatric operation included foregut~     and hind gut theory. Actually, both hindgut and foregut effects on sugar control are~     achieved to some extent after pancreaticoduodenectomy. First, most of the duodenum is~     routinely removed in PD and there will be no food passage through duodenum (foregut theory)~     after PD. Second, proximal 10 cm of jejunum will be removed in PD and another 30~ 40 cm-~     long jejunum will be brought up for pancreatic and biliary anastomosis, which will make the~     last enteral anastomosis (gastrojejunostomy or duodenojejunostomy) be created at site about~     50-60 cm distal to Treitz ligament. Therefore, food will directly pass into distal jejunum~     (hindgut theory). In our preliminary study, 35% patients have resolution of diabetes after~     PD, especially for ones with new-onset DM. Further, a prospective randomized clinical trial~     will be conducted to address if modified distal gastro-/duodeno-jejunostomy results in a~     higher proportion of diabetes remission compared with standard PD.~   "
99458|NCT01755260|"~     The aim of this study is to compare the closure rate of pancreatic fistula (PF) after~     pancreaticoduodenectomy (PD) under various types of nutrition.~   "
99459|NCT01755247|"~     This is a 3 day study to assess safety and tolerability of a new topical gel product,~     NVN1000 with and without the application of a commercially available moisturizer in~     approximately 15 healthy subjects. The test product will be applied to the forehead of~     healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer~     applied to the same area 15 minutes after the test gel was applied and one group of subjects~     will be treated with the gel vehicle which does not contain the active product. The~     hypothesis is that the application of moisturizer will not effect safety or local~     tolerability.~   "
99460|NCT01755234|"~     80% of 25 million American who undergo surgery describe moderate to severe pain. The use of~     multimodal analgesic techniques can attenuate patient's postoperative pain and several~     different medication have been found to be effective. Pain can significantly affect~     patient's quality of recovery after surgery. Volatile anesthetics can increase sensitivity~     to pain at the low concentrations present on emergence from anesthesia. Propofol may have~     analgesic effect at sedative doses. The effects of propofol,when used for anesthesia~     maintenance, on postoperative pain have demonstrated controversial results with some~     investigators showing a potential benefit whereas others have not shown any benefit.~     Propofol for maintenance of anesthesia has been advocated as an strategy for high risk~     patients even though it has shown controversial results on reduction of Post operative~     nausea and vomiting. A comparison of propofol vs.volatile anesthetic in regards to the time~     required by patients to meet discharge criteria has also shown conflicting results.The QOR~     40 is a validated instrument that has been specifically developed to evaluate patients~     recovery after anesthesia and surgery.~      The purpose of this study is to compare the effects of maintenance of anesthesia with two~     agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery~      Significance: the results of this study can lead to the discovery of an anesthesia technique~     that is associated with a better recovery for patients after ambulatory surgery.~      Research question is: do patients anesthetized with propofol have a better quality of~     recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The~     hypothesis: patients anesthetized with propofol will have better quality of recovery than~     patients anesthetized with Sevoflurane after ambulatory surgery.~   "
99461|NCT01755221|"~     The purpose of this research study is to better understand whether information obtained from~     a pH probe can help physicians predict whether a patient will respond to the medication that~     is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals~     who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. Subjects~     who agree to participate in this study will have a small flexible tube (about the width of a~     piece of cooked spaghetti) placed in their throat. This tube measures the pH in the throat~     over a period of 24 hours and helps physicians study the relationship between pH level, LPR~     symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if~     certain symptoms or characteristics can help them predict if the PPI medication will be~     effective for each patient. After probe removal, subjects will receive compensation. They~     will return to the clinic at their regularly scheduled follow-up visit with the physician, 8~     to 12 weeks after starting the PPI medication. At that time, subjects can choose to~     participate in an optional probe placement.~   "
99462|NCT01755208|"~     This pilot clinical trial studies light-scattering spectroscopy in finding disease in~     patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering~     spectroscopy, may help find and diagnose breast cancer~   "
99463|NCT01755195|"~     Background:~      - Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in~     tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar~     drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see~     if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not~     responded to earlier treatments.~      Objectives:~      - To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded~     to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have soft tissue sarcomas that have not responded~     to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies and other tests will be used to study the tumor~          before the start of treatment.~        -  Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The~          tablets should be taken whole on an empty stomach.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take cabozantinib for as long as the tumor does not~          become worse and the side effects are not too severe.~   "
99464|NCT01755182|"~     The purpose of this study is to verify if adding a locoregional treatment of liver~     metastasis (with trans-arterial embolization-TAE) to medical treatments of proven efficacy~     can prolong the progression free survival of patients affected by neuroendocrine tumors~     (NET) with inoperable liver metastases~   "
99465|NCT01755169|"~     This study is designed to select the most tolerable dose of oral ketamine for children with~     chronic pain. Children will be given either placebo or one of three dosages of oral ketamine~     for 2 weeks. The dosage that is most tolerable will be selected for further study.~   "
99466|NCT01755156|"~     The purpose of this study is to assess the safety and efficacy of MK-3102 compared to~     placebo in participants with inadequate glycemic control on metformin monotherapy. The~     primary hypothesis is that after 24 weeks, the addition of treatment with MK-3102 provides~     greater reduction in hemoglobin A1c (A1C) than placebo.~   "
99474|NCT01755052|"~     SILVER-AMI is a research study of older persons who are admitted to the hospital with a~     heart attack. Patients will be interviewed in the hospital and again 6 months later. The~     researchers will also collect detailed medical record information to understand the effect~     of heart attacks on older persons.~      The research team at Yale University will use this information to develop a risk model that~     can be used to help doctors predict recovery. The goal of the study is to help older people~     in the future make well-informed decisions about their health care during a heart attack.~   "
99475|NCT01755039|"~     The purpose of the study is to determine the frequency and management of respiratory~     incidence in patients with invasive out-of-hospital ventilation, either living at home for~     elderly people allay to a weaning centre or at home. Further, the mortality and the~     frequency of hospital admission will be analyzed.~   "
99476|NCT01755026|"~     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater~     (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an~     antibiotic before surgery. The antibiotic is intended to prevent infection from the~     surgery.It is unknown what the best dose for large women is for the usual medicine used for~     this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the~     skin will be biopsied at the time the incision is made and at the time the cut is stitched~     or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched~     closed after the delivery. Blood tests will be done at the start and end of surgery to test~     the antibiotic level. A blood sample will be taken from the umbilical cord after the baby~     has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will~     be tested for the antibiotic level.These tests will be used to find out if the usual dose of~     medicine is enough or if more medicine is needed to prevent infection in large women~     undergoing c-sections.~   "
99477|NCT01755013|"~     Successful palliation of biliary obstruction is the main goal for reducing morbidity and~     mortality in patients with biliary disease and biliary obstruction related to~     cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a~     30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time~     the quality of life following surgery is only improved in a minority. At present endoscopic~     insertion of a plastic or metal stent is the method of choice to relieve obstructive~     jaundice without the high morbidity and mortality associated with surgery. But this relief~     is unfortunately temporary since stents tend to become obstructed and the fact that~     effective biliary drainage in the proximal lesion is challenging.~      Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets~     neoplastic cells. This therapy involves the intravenous administration of a photosensitizing~     agent followed by activation of the agent by illumination with non-thermal light of a~     specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis.~     A randomized controlled trial study by Ortner et all confirmed the significant advantage of~     PDT with regard to relief of jaundice, quality of life, and survival.~      In photodynamic therapy (PDT) the uniform distribution of externally applied light is~     desirable but often difficult to achieve. An optical fiber tip producing cylindrical or~     lateral light emission can facilitate the application of laser energy by direct implantation~     of the tip into solid tumors. However, currently used FDA approved glass diffusers used in~     standard of care PDT might break in the bile ducts causing injury since they are not meant~     to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need~     to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser~     for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer~     plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used~     via a choledochoscope. We aim to add to the clinical evidence by conducting an open label~     observational study trial using this fiber optic diffuser during photo dynamic therapy in~     the bile ducts.~   "
99478|NCT01755000|"~     The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac~     Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those~     with blood cancers). Additionally, the researchers will learn if the USCOM gives additional~     information about patients' conditions when their blood pressures drop and they are treated~     with intravenous fluids.~   "
99479|NCT01754987|"~     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment~     with sorafenib versus treatment with sorafenib alone in subjects with metastatic~     hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the~     concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to~     assess overall tumor response rate and evaluate disease progression~   "
99480|NCT01754974|"~     The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda~     plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared~     to therapy with Peginterferon alfa-2a plus Ribavirin.~   "
99481|NCT01754961|"~     Chronic liver diseases are associated with inflammation. The investigators postulate that~     Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin~     D replacement in patients with Hepatitis C infection and Vitamin D deficiency.~   "
99482|NCT01754948|"~     Background Ambient airborne particulate material (PM) is defined according the aerodynamic~     diameter into coarse, fine, and ultrafine or nano sized particles ranging between 2.5-10~     µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect~     on respiratory health in children, mainly by environmental monitoring of coarse and fine~     particles. Biological assessment of individual exposure to nano sized particles in~     correlation to adverse health effect was not previously studied.~      Hypothesis individual exposure to nano sized particles in children is associated with~     reduction in forced expiratory volume at one second.~   "
99483|NCT01754935|"~     The current study is designed to evaluate the safety and efficacy, including MRI imaging,~     across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have~     had an inadequate response to disease-modifying antirheumatic drugs (DMARDs).~   "
99484|NCT01754922|"~     Following deployment to Operations Enduring and Iraqi Freedom and Operation New Dawn~     (OEF/OIF/OND), Veterans report breathing problems, difficulty exercising and other symptoms.~     These symptoms may be related to deployment exposures, such as regional dust and sand, smoke~     from burning trash, and local industry. Studies have reported poor air quality, but very~     little is known about the effect that exposure to this polluted air may have on Veterans'~     short- and long-term health. Investigators will determine whether deployment-related~     exposures have affected respiratory and nervous system function in these Veterans - data~     that may then be used to guide rehabilitation. Ultimately, the investigators' long-term goal~     is to prevent the development of chronic respiratory conditions in this group of OEF/OIF/OND~     Veterans.~   "
99650|NCT01752764|"~     The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from~     a salad. Therefore we designed the current study to show an increase in relative absorption~     (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.~   "
99485|NCT01754909|"~     This project will test the effect of enalapril to mitigate the lung damage that can occur as~     a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands~     of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of~     lung radiation injury in laboratory animals show that with enalapril, investigators can~     significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved~     and in common use for treatment of hypertension, kidney disease, and heart failure. These~     studies will advance that work to human use. Successful mitigation of lung radiation damage~     will improve the quality of life in Veterans and non-Veterans who are treated for lung~     cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.~   "
99486|NCT01754896|"~     Prior to implementation of new colorectal cancer (CRC) screening technology (fecal~     immunochemical test - FIT) in Ontario, there is a need for a laboratory and field assessment~     to validate and optimize its use in the Ontario climate and conditions (e.g., large~     geographic area) and to determine whether adjustments to the current structure of the~     ColonCancerCheck (CCC) Program would be required.~      This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to~     evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is~     a field assessment to evaluate the effect of different distribution and return methods and~     pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18~     months to complete, with patients being recruited through family physicians in patient~     enrollment model (PEM) family practices across the province of Ontario.~      This Clinical Trials registration relates to Phase 2 of the study.~   "
99487|NCT01754883|"~     The purpose of this study is to explore the effectiveness of adding lithium carbonate~     (lithium) to treatment for combat-related post traumatic stress disorder in combat veterans.~     The goal of this study is to establish that lithium is a practical and tolerable treatment~     option for veterans with combat posttraumatic stress disorder.~   "
99488|NCT01754870|"~     CLL/SLL is an incurable disease with conventional chemotherapy, and there are limited~     treatment options available for patients who have become refractory to fludarabine- and~     alkylating-agent based regimens. Bendamustine is a recently FDA-approved agent with~     significant activity in CLL/SLL, including significant activity in the setting of~     fludarabine-refractory disease. However, durations of remission following~     bendamustine/rituximab combination therapy tend to be short in patients with heavily~     pre-treated disease or who have already received rituximab.~      The incorporation of a maintenance therapy to overcome the shorter remission durations in~     this population is a reasonable and feasible option. In considering potential options for~     treatment of CLL/SLL as a maintenance strategy following induction chemotherapy,~     lenalidomide and rituximab are appealing options based on their convenient dosing schedules~     and recent evidence of acceptable toxicity and promising efficacy in combination therapy.~   "
99489|NCT01754857|"~     The investigators propose a treatment strategy where patients are treated with induction~     chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by~     initiation of maintenance rituximab and lenalidomide among patients achieving an objective~     response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The~     goal of maintenance therapy will be to capitalize on the cytoreduction following induction~     chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in~     order to allow for improved PFS in this population.~   "
99490|NCT01754844|"~     This is a First in Human study to assess the safety and tolerability of AZD7624, following~     inhaled administration of single ascending doses in healthy male volunteers and female~     volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug)~     and pharmacodynamic (what the drug does to the body) parameters will be also assessed as~     secondary objectives.~   "
99491|NCT01754831|"~     The specific aim of the study is to determine the excess urinary fluoride and its time~     course after administration of an application of Premier Enamel Pro Varnish to the teeth of~     12-15 month old infants. From these data the investigators can estimate the bioavailable~     (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride~     concentration that will allow an estimate of the margin of safety of the procedure.~   "
99492|NCT01754818|"~     The purpose of this study is to assess the study medication blood levels after~     administration of a single oral capsule of Bendavia at one of three dose levels. The effects~     of Bendavia on the volunteers will also be assessed.~   "
99493|NCT01754805|"~     A drug interaction study to evaluate the effect of ASP015K (twice daily) on the~     pharmacokinetics (PK) of once weekly oral methotrexate (MTX).~   "
99494|NCT01754792|"~     The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism~     parameters, and evaluate its effect on oxidative stress and endothelial function in~     diabetic, impaired and normal fasting glucose subjects.~      This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design.~     Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or~     normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.~   "
99495|NCT01754779|"~     The investigators will examine in two studies whether citric acid or potassium citrate can~     reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.~   "
99496|NCT01754766|"~     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic~     conjunctivitis.~   "
99504|NCT01754662|"~     Diabetes is an increasingly common condition affecting millions of people world wide. The~     cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is~     known that food containing compounds called polyphenols can reduce the risk of heart disease~     risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa~     (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these~     foods in the diets of people with diabetes. It has also been shown that soy isoflavones and~     cocoa polyphenols can improve the mood in certain groups of patients.~      What is not known is whether there is any extra benefit of combining soy protein and~     isoflavones with cocoa.~      The aim of the study is to look at the modification of cardiovascular risk by soy and/or~     cocoa in patients with type 2 diabetes, alone or in combination.~   "
99738|NCT01751607|"~     This prospective study aims to examine the association of specific genetic variants (single~     nucleotide polymorphisms) located on chromosome 1, 4 and 16, with presence of non-pulmonary~     vein triggers (NPVT) as well as ablation-outcome in AF patients~   "
99497|NCT01754753|"~     The National Institute for Health Research commissioned this research with the following~     research question: What is the relative effectiveness and cost effectiveness of home based~     support programmes in improving the mental wellbeing of older people living in their own~     homes?~      The project will evaluate whether telephone friendship groups, delivered by the voluntary~     sector over the telephone, can improve the mental wellbeing of older people aged 75 or over.~      The research will also:~        1. Identify the psychosocial and environmental factors, as well as implementation issues~          that may mediate or modify the effectiveness of the intervention using qualitative~          methods. This will include examining: 1.1. Assess voluntary sector readiness to take~          forward new forms of services; 1.2. The best modes of delivery of telephone~          support/friendship; 1.3. Assess how volunteers (facilitators) can be supported and~          retained; and, 1.4. The extent to which fidelity of the intervention is maintained~          within and across the participating organisations.~        2. Determine if there is any lasting impact upon mental wellbeing by repeat measurement~          with all participants 12 months following baseline measurement~        3. Examine whether there is any significant improvement on the physical dimension of the~          SF-36 at 6 months and 12 months, following baseline measure, for the intervention arm~          compared with usual care.~        4. Measure the extent of use of health and social care, and community facilities by~          participants over time to determine whether the intervention is cost effective compared~          with usual care.~   "
99498|NCT01754740|"~     Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome~     (BMS) treated with amitriptyline before and after the use of antixerostomic topical~     medication.~      Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS~     diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study~     Group: 19 patients whom received topical medication of urea 10% and Control Group: 19~     patients whom received placebo to apply at the oral cavity 3-4 times per day, during three~     months. The patients were evaluated before and after the above treatment. Finally, data were~     statistically analyzed.~      It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho~     et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing~     concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the~     absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et~     al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have~     several sensory losses even in taste and smell function, recently described (Siqueira et~     al., 2006a; Siqueira et al., 2006b; Siviero et al., 2011).~   "
99499|NCT01754727|"~     Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to~     the health care system as well as the whole society. The introduction of biologic therapy,~     though allowing for superior clinical and work productivity outcomes, has significantly~     increased direct medical costs of AS. Therefore it is important to weight the benefits~     against the costs to gain a basis for decisions on health care resource allocation.~      Due to differences in the health care systems, health insurance and general country~     settings, health economic data cannot be generalized across countries. Such data is~     generally lacking in Central and Eastern European countries, especially in the field of~     rheumatology. This study will evaluate selected health care resource utilization and~     productivity losses in patients with AS during and before the treatment with adalimumab in~     clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance,~     hospitalizations and sick leave, which could be influenced by relatively short-term~     adalimumab therapy, will be taken into account, and in relation to treatment response. There~     is no published data on the impact of adalimumab therapy on hospitalizations and outpatient~     attendance in patients with AS. Further, data on health care resource utilization and sick~     leave before and during adalimumab therapy could be translated into financial cost estimates~     (potential cost savings) by each participating country, based on their own country specific~     cost per resource.~   "
99500|NCT01754714|"~     Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty~     Liver Disease and non-treated matched healthy volunteers as control group~   "
99501|NCT01754701|"~     The purpose of this study is to determine whether iron therapy given to iron-deficient~     Ugandan children with moderate-to-severe anemia and clinical malaria is better absorbed and~     incorporated into red blood cells if it is given concurrently with antimalarial treatment on~     Day 0 (immediate group) or 4 weeks after antimalarial treatment on Day 28 (delayed group).~     Use of iron stable isotopes 57Fe and 58Fe will permit measurement of red blood cell iron~     incorporation on Day 0 and Day 28 in all children. The investigators hypothesize that red~     cell iron incorporation at the time of initial supplement administration will be greater in~     children receiving delayed vs. immediate iron (Aim 1), and children in the delayed group~     will also have greater hematological recovery on Day 56 than children in the immediate group~     (Aim 2).~   "
99502|NCT01754688|"~     The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction)~     scoring method adapted for the developing world (BIND II, developed by our team for use by~     health care workers), with additional modifications for community use (the community BIND,~     C-BIND), will improve the ability to identify infants with ABE and to distinguish ABE from~     other common causes of neonatal morbidity and mortality compared to currently available~     survey tools.~   "
99503|NCT01754675|"~     Watching football matches could cause increased blood pressure and heart rate induced by~     catecholamines and thus increase the incidence of cardiovascular events. However, no studies~     have evaluated the responses of blood pressure and heart rate in soccer spectators.~      This study evaluates the hemodynamic response in Brazilian soccer fans suffering from~     coronary artery disease during a dispute over a game of your favorite team.~   "
99505|NCT01754649|"~     To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled~     randomized clinical trial)to facilitate the insertion of copper-IUD and the~     levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical~     stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects~     of the misoprostol. The hypothesis is that misoprostol may be better than placebo.~   "
99651|NCT01752751|"~     A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used~     in non-radiation oncology clinical settings to predict how older adults tolerate cancer~     treatments. The investigators think this same tool (referred to as the CGA) can be used in a~     radiation oncology clinic to predict for poor treatment tolerance.~   "
99506|NCT01754636|"~     Background: Inadequate representation of elderly cancer patients in randomized clinical~     trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding~     benefit-risk balance of cancer treatment in elderly, especially chemotherapy.~      Hypothesis: The eligibility criteria explain only a part of the under-representation of~     elderly patients in trials. We make the assumptions that 1) Among the eligible, the~     invitation to participate in a trial and inclusion are inversely related to age, 2) Among~     the eligible, there are patients, practitioner, or organization factors that would explain~     the non inclusion of elderly patients.~      Objectives:~      1) To assess, in elderly patients with colorectal cancer, the proportions of patients:~        1. eligible at least to one RCT~        2. invited to participate~        3. included 2)~      a) Compare proportions among elderly patients to those of the comparator group of young~     subjects (age ≥ 18 and <65 years) (added by amendment n°3 - 02/2014) b)To identify factors~     associated with the non-invitation and the non-inclusion in RCT.~      Material and methods:~      Study design: A multicentric prospective cohort survey Population: all patients aged 18~     years or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of~     the participating centers.~      Data collection:~        -  At baseline: Patient characteristics (including SOCIO-demographic, oncologic and~          geriatric data) will be collected. Organization factors (e.g. clinical research team)~          will be collected.~        -  Follow-up: the patient will be followed for potential invitation and inclusion in one~          RCT. Reasons of non-invitation or non-inclusion will be assessed.~      Number of subjects needed: 696 Number of centers : 7 (added by amendment n°3 - 02/2014)~      Ethical aspects: each patient will give his oral informed consent. The International Review~     Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.~   "
99507|NCT01754623|"~     The purpose of this study is to find out if a program of intensive chemotherapy with~     gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation~     aimed at participant's tumor followed by more chemotherapy can increase the chances that the~     participant's pancreatic tumor can be removed completely.~   "
99508|NCT01754610|"~     Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the~     National Institute on Drug Abuse's intervention development model by testing a new family,~     skills-based intervention involving pre-post evaluation of families participating in~     multi-family groups. The purpose of this study is to gather practice-based evidence on the~     effectiveness of the manualized treatment, on the dynamics involved in the group format, and~     on implementation fidelity and feasibility. Analyses will involve initial exploration of the~     following hypotheses: 1) Families will show a significant increase in the constructive use~     of family coping skills and in general family functioning. 2) The target child will show a~     reduction in trauma-related symptoms and behavior problems. 3) Families will engage and~     participate in the treatment. 4) Providers will implement SFCR with fidelity.~      Other outcomes of interest are the process measures that will be collected to monitor~     participation in the groups, cultural sensitivity and acceptability, clinician competence,~     and intervention integrity.~   "
99509|NCT01754597|"~     The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical~     and echocardiographic monitoring. In the case of treatment for breast cancer, surgery~     requiring general anesthesia may follow chemotherapy. Although a possible interaction~     between general anesthetics and anthracyclines on systolic function is only rarely~     mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were~     observed in patients treated or previously treated with anthracyclines. The determination of~     concentration of BNP is a diagnostic tool used in the detection of heart failure and acute~     coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines~     and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value,~     the BNP assay might thus allow to highlight a possible subclinical deficiency. To our~     knowledge, there is very little data regarding a possible synergism between cardiotoxic~     anthracyclines and anesthetic agents.~   "
99510|NCT01754584|"~     The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory~     epithelium, the mucous blanket, and the mucus-producing glands, is an important defense~     component of the respiratory system. Therefore, it is important to maintain intact inner~     respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the~     development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable~     and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes.~     However, the feasibility of use as a scaffold for respiratory epithelial cells remained~     unexplored. The aim of the study is to investigate the effect of hyaluronan including~     concentrations and molecular weight on the mucociliary differentiation of human respiratory~     epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of~     HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials~     for respiratory tissue engineering and tissue-engineered trachea in the future.~   "
99511|NCT01754571|"~     According to the definition from International Headache Society, medication overuse headache~     (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month~     (depending on what kind of painkillers being used), for more than 3 months, which results in~     the deterioration of headache. The treatments of MOH include preventive medication of~     headache and withdrawal of the overused painkillers. Other than the simple oral advice, some~     researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed~     the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior~     therapy (CBT), psychological therapy, hypnosis and physical treatment are effective.~     Researches also point out CBT is effective on withdrawing medication in patients with MOH~     (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct~     therapy to preventive medication to reduce the relapse rate of medication overuse.~      The purpose of this study is to confirm the effect of CBT in patients with MOH. The target~     is to reduce the frequency of headache and use of painkillers. Patients could benefit from~     the education and relaxation training during CBT to cope with headache and reduce the use of~     painkillers.~      The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial~     Hospital. They will be separated into two groups, 30 in control group and the other 30 in~     the experimental group. Education of MOH, relaxation and cognitive restructuring would be~     included in the four weeks training program. The training program is under the supervision~     of a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen~     Catholic University. The control group will accept four weeks telephone interview to confirm~     their headache diary including the frequency of headache and use of painkillers. The~     frequency of headache and medication use will be used for analyzing the effect of CBT.~   "
99521|NCT01754441|"~     Spinal muscular atrophy is a genetically based disease that affects motor neurons in the~     spinal cord and leads to muscle wasting and weakness. The gene found to be responsible for~     the underlying disease is called the SMN or survival motor neuron gene. Individuals with SMA~     are either missing a copy of the gene or have a mutation in the gene. Although the gene has~     been identified, how it actually causes the motor neurons to die and leads to muscle wasting~     and weakness is not completely understood. The investigators have found that skin cells from~     children with SMA tend to be more susceptible to cell death when exposed to cell death~     inducing agents. In this protocol, The investigators wish to study the mechanisms by which~     these cells die when exposed to these agents and how this may be related to the gene defect~     and the disease.~   "
99522|NCT01754428|"~     The purpose of this study is to collect clinical outcome and nasal viral load information.~   "
99523|NCT01754415|"~     The aim of this study is to evaluate the effect of hydraulic resistance circuit training for~     elderly people with chronic illness.~   "
99512|NCT01754558|"~     During the last decade numerous new procedures have been presented regarding surgical~     treatment of urinary stress incontinence (1,2). Development of the midurethral tape~     procedure (TVT) changed the surgical procedure dramatically both regarding the extent of the~     surgical procedure and also decreased the morbidity remarkably. The success rate of the TVT~     procedure has been proven to be high (1,2 ). However, the development of the TOT/TVT-O~     procedures disclosed a new fixation point and further decreased the risk of bladder injury~     (1,2). Since the introduction of trans-obturator slings several mini-slings have been~     introduced in order to reduce the need of perforation of the skin and muscles (3,4,5).~     Although some systems seem promising (5) others have disclosed a long learning curve, pain~     problems following the procedure and lower success rates, compared to the traditional sling~     procedures. None of these mini-slings have been adjustable.~      Recently the Ajust system for treatment of stress urinary incontinence was introduced. The~     system is a single incision sling procedure and consists of an adjustable Polypropylene mesh~     sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective~     cure rate was 82%, but there is a lack of information regarding adverse events and~     durability of treatment success. Our preliminary experiences suggest, that the procedure has~     a rapid learning curve, low pain scores postoperatively and a 94% cure rate at 3 months~     follow-up (personal observation). Recently, several abstracts have indicated that the cure~     rate obtained by Ajust is comparable to TVT or TVT-O (10-12).~      The purpose of the present study is (primary outcome):~      To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal~     regarding subjective cure rate (cure is defined as subjectively not incontinent at all),~     i.e. the study is designed as a non-inferiority study. The study is performed as a~     randomised controlled trial without blinding. The study is powered to detect a 9% difference~     between the two groups. The subjective cure rate is based on ICIQ measurement~      Secondary outcome:~        -  To test the hypothesis that Ajust is associated with a significantly lower~          postoperative pain perception.~        -  To test the hypothesis that antibiotic treatment is not necessary~   "
99513|NCT01754545|"~     Congenital thrombotic thrombocytopenic purpura (TTP), also called Upshaw-Schulman Syndrome~     or hereditary or familial TTP is a rare, but severe disease. The purpose of this study is to~     determine how infusions of plasma to patients with congenital TTP correlate with symptoms~     and signs of activity of the disease, and to determine why some patients need more frequent~     infusions of plasma than others to prevent acute attacks of the disease.~   "
99514|NCT01754532|"~     The importance of stress as a possible deteriorating factor for schizophrenic patients is~     well documented. However, this notion is based on subjective experience and retrospective~     psychological analysis.~      A novel method of measuring cortisol using hair has a proven correlation to subjective~     stress in non-clinical as well as psychiatric clinical populations.~      This pilot study will attempt to assess the use of cortisol hair level, as a marker of~     stress, to predict clinical deterioration in schizophrenic patients.~   "
99515|NCT01754519|"~     This phase II trial studies how well radiation therapy works in treating post-menopausal~     women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy~     x rays to kill tumor cells. This may be an effective treatment for breast cancer.~   "
99516|NCT01754506|"~     The purpose of this study is to test the efficacy of an oral, nutrient intervention~     containing the bioactive components of fish oil to promote healing of chronic venous leg~     ulcers (CVLU). If this systemic, nutrient intervention is found to alter the~     microenvironment of CVLU, the science of wound healing and care of patients with CVLU will~     be vastly improved.~   "
99517|NCT01754493|"~     This study will evaluate the efficacy of duloxetine in reducing depressive symptoms,~     abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of~     outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.~   "
99518|NCT01754480|"~     This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in~     patients undergoing open surgical procedures where bleeding may be present on parenchymous~     tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to~     demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized~     cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage~     of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with~     the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to~     assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study,~     patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.~   "
99519|NCT01754467|"~     Sedentary behavior is associated with an increased risk of mortality and many health~     conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic~     syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity~     (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed~     that individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent~     experimental findings also suggests that breaking up prolonged bouts of sedentary behavior~     (≥ 20 minutes) with either light or moderate intensity activity for 2 minutes reduces~     postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity~     activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health~     consequences of sedentary behavior. The purpose of this study is to develop a smartphone~     application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in~     prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will~     be refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work~     in conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary~     behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will~     trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at~     least 2 minutes. Following the development, testing, and refining of the application, a~     sample of 10 sedentary adults with type 2 diabetes will be recruited to participate in a one~     month trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is~     the first study to design and examine the acceptability of a smartphone application that~     will target interrupting sedentary behavior with NEAT using objectively measured sedentary~     time in a diabetic population.~   "
99520|NCT01754454|"~     Allogenic haemopoietic stem cell transplantation (allo-HSCT) is the treatment for many~     malignant and non-malignant hematologic disorders. Acute graft-versus-host disease (aGVHD)~     is a serious life-threatening complication after allo-HSCT. The outcome for patients with~     aGVHD is poor and overall survival is low. Acute graft-versus-host disease (GVHD), as the~     major complication of allogeneic peripheral blood stem cell transplantation(PBSCT), limits~     the application of this curative therapy. Mesenchymal stem cells (MSCs) are multipotent stem~     cells, which are able to modulate immune response in vitro and in vivo, and have~     possibilities of treating diseases caused by immune dysregulation such as aGVHD. MSCs~     obtained from umbilical cord (UC) have similar immunosuppressive properties as bone~     marrow-MSCs. In addition, UC-derived MSCs can be used for off-the-shelf use and are obtained~     without any harm to donors than bone marrow-MSCs. Therefore, the investigators designed this~     study to evaluate the safety and efficacy of UC-derived MSCs in patients with aGVHD.~   "
99524|NCT01754402|"~     This study is designed as a phase I-II, open label, dose finding study.~      Study treatment will be as follows, in 28 day cycles:~        -  Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days~        -  Bendamustine: once intravenously (IV) dosing on day 1, every 28 days~        -  Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.~      After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per~     investigator discretion. After completing 12 cycles of treatment, patients will proceed to~     the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28~     days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.~   "
99525|NCT01754389|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not yet approved bortezomib to treat or prevent~     graft-versus-host disease. Bortezomib is approved by the FDA to treat other human~     malignancies.~      Bortezomib is a drug that has an anti-cancer effect that involves inhibiting cell growth and~     causing cell death. This drug has been used in other research studies, and information from~     thos other research studies suggests that bortezomib may help to lower the risk of GVHD~     after allogeneic stem cell transplantation in patients who have matched unrelated, unmatched~     related or unrelated donors in this research study.~      Allogeneic stem cell transplantation is a procedure in which selected blood cells taken from~     your sibling or unrelated donor are given to you. Lower doses of chemotherapy drugs are~     given before the donor cells are infused in a process known as reduced-intensity~     conditioning. Stem cell transplant destroys cancer in two ways: The conditioning regimen~     destroys cancer cells and teh immune cells from the donor can recognize cancer cells and~     kill them.~      A common problem after stem cell transplant is graft-versus-host disease (GVHD). The word~     graft refers to the donor blood cells that you will receive during your transplant. The~     word host refers to the person (in this case, you) receiving the cells. GVHD is a~     complication of transplantation where the donor graft attacks and damages some of your~     tissues. GVHD can cause skin rash, intestinal problems such as nausea, vomiting or diarrhea.~     GVHD may also damage your liver and cause hepatitis or jaundice. GVHD may also increase your~     risk of infection.~      After stem cell transplant, all patients receive prophylactic medications against GVHD. In~     this research study we are studying the safety and effectiveness of preventing GVHD using~     bortezomib treatment in combination with other drugs versus standard of care prophylaxis~     (tacrolimus + methotrexate). If you take part in this study, there is a 33% chance you will~     receive any one of the following GVHD prevention treatments:~        -  tacrolimus + methotrexate (standard of care GVHD prophylaxis)~        -  bortezomib + tacrolimus + methotrexate~        -  bortezomib + sirolimus + tacrolimus Sirolimus, tacrolimus and methotrexate are drugs~          that suppress the immune system to try to prevent GVHD.~   "
99526|NCT01754376|"~     This research study is a Phase II clinical trial of an investigational combination of drugs~     (vemurafenib and aldesleukin) to learn whether the combination works in treating a specific~     cancer. While both vemurafenib and aldesleukin are approved by the FDA for the treatment of~     metastatic melanoma, the FDA has not yet approved the combination of vemurafenib and~     aldesleukin.~      Researchers have found that a large number of melanoma cells have mutations in the BRAF~     gene. It has been shown that vemurafenib blocks the effects of these mutations in the BRAF~     gene, and, as a result, may help to prevent cancer growth.~      Aldesleukin, also referred to as IL-2, is an immunotherapy drug administered via IV infusion~     that increases the growth of key cells within the immune system that are responsible for~     targeting cancer cells. Activating more of these key cells, called T-lymphocytes and~     natural-killer cells, leads to increased cancer cell death.~      The BRAF gene is located on a larger pathway called the MAPK pathway. Studies have shown~     that when a BRAF inhibitor, like vemurafenib is used to block the MAPK pathway, melanocytes,~     or cancer cells express more proteins on their surfaces, making them easier for~     T-lymphocytes and natural killer cells to recognize and kill them. This suggests that~     combining BRAF-targeted therapy with aldesleukin, which activates more of these white blood~     cells, can lead to an increase in the death of cancer cells.~      In this research study, we are looking to see whether the combination of vemurafenib, a~     BRAF-inhibitor combined with aldesleukin, an immunotherapy drug, work together to produce a~     better health outcome in people with metastatic melanoma.~   "
99527|NCT01754363|"~     This post-marketing investigation will evaluate the long term (up to 15 years) survivorship~     of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint~     disease. Data from Subjects who receive one of four knee configurations will be pooled to~     establish a contemporary dataset.~   "
99528|NCT01754350|"~     Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is~     important for the generation of ATP, supply of anabolic substrates and defense against~     reactive oxygen species in tumor cells. In preclinical models, restricting glucose~     availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor~     growth.~      Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic~     diet and transient fasting can enhance the efficacy of reirradiation in patients with~     recurrent glioblastoma.~   "
99529|NCT01754337|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a~     24-hours in-patient study with standardized conditions in adults and adolescents with type 1~     diabetes.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating glucose levels in adults and adolescents with type 1 diabetes compared to~     single-hormone closed-loop strategy, which in turn is more effective than the conventional~     pump therapy.~   "
99530|NCT01754324|"~     The chronic use of opiate medications during pregnancy is a major public health challenge.~     Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly~     referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability,~     high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and~     unstable body temperature. Many infants may be treated by supportive (non-pharmacological)~     therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other~     comfort care. However, some infants continue to show severe symptoms of withdrawal despite~     these interventions. In these cases, infants may be treated with medications~     (pharmacological therapy). Although it has been several decades since the first descriptions~     of NAS, there still remains limited information with regards to the most effective~     treatment. We hypothesize that medical treatment protocols of NAS with methadone can be~     optimized by better understanding what the body does to the drug (the population-based~     pharmacokinetics of methadone).~   "
99544|NCT01754142|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the~     marketing approval properly~   "
99600|NCT01753414|"~     Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung~     cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer~     but higher and possibly more effective doses of radiation than standard radiation. This~     technique may be able to send x-rays directly to the tumor and cause less damage to normal~     tissue. It is not yet known whether stereotactic body radiation therapy is more effective~     than surgery in treating non-small cell lung cancer.~      Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy~     of SBRT is comparable to that of standard surgical interventions for patients with T1N0~     non-small cell lung cancer.~   "
99531|NCT01754311|"~     Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The~     two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis~     /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM~     in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1~     proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic.~      Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its~     rapid evolution is partly attributed to the failure of the immune system that regulates~     viral replication and expression.~      It has recently been shown that different versions of Single Nucleotide (human leukocyte~     antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced~     the severity of infection with hepatitis C and effectiveness of treatment.~      By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single~     nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT~     genotype was statistically more frequent in the group TSP / HAM than in asymptomatic~     patients (80% versus 20%) and was associated with HTLV-1 proviral load higher.~      We propose a broader group of patients in our population and Afro-Caribbean, to confirm the~     results of the latter study was conducted in a predominantly Latin American population.~   "
99532|NCT01754298|"~     The purpose of this study is to compare the functional, clinical and radiographic outcomes~     associated with trans-articular drilling versus retro-articular drilling, two commonly~     employed techniques of operative treatment for stable forms of juvenile osteochondritis~     dissecans (JOCD) lesions. This study also aims to better define the natural history of this~     condition in its most commonly identified pathological state (as a stable lesion) following~     surgical intervention by determining the rate of radiographic healing and any need for~     secondary surgery.~   "
99533|NCT01754285|"~     This is a phase II, multicenter, double-blind, double-dummy, parallel-group,~     placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest~     cancer who are undergoing breast surgery with axillary lymphnode dissection.~      Recruited patients will be randomly assigned to one of the following treatment groups:~     Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.~      Mode of administration is single intramuscular (IM) injection so the treatments arms are as~     follows:~      Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2~     injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg~      The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.~   "
99534|NCT01754272|"~     This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to~     acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who~     have participated in the VELOUR study.~      These samples will be analysed to find proteins or markers which represent how an individual~     may be responding to treatment. The identification of these markers may help provide~     personalised and more effective treatment programs for patients with similar conditions in~     the future.~   "
99535|NCT01754259|"~     Coronary vascular dysfunction is highly prevalent among patients with known or suspected~     Coronary Artery Disease (CAD)1, increases the severity of inducible myocardial ischemia~     (beyond the effects of upstream coronary obstruction)2, and identifies patients at high risk~     for serious adverse events, including cardiac death1, 3-5. Diabetic patients without known~     CAD with impaired coronary vascular function show a risk of cardiac death comparable to, and~     possibly higher, than that for non-diabetic patients with known CAD10. In the setting of~     increased oxygen demand, coronary vasodilator dysfunction can upset the supply-demand~     relationship and lead to myocardial ischemia, subclinical left ventricular dysfunction~     (diastolic and systolic), and symptoms.~      The significance of microvascular coronary dysfunction is increasingly recognized as~     invasive and non-invasive (PET) methods of quantifying CFR become available.~      Importantly, current treatment strategies for obstructive CAD, such as percutaneous coronary~     intervention with angioplasty and stenting, are not helpful in microvascular disease.~     Similarly, mortality-altering treatments for systolic heart failure, such as angiotensin~     converting enzyme inhibitors, have not been beneficial in treating diastolic dysfunction.~   "
99536|NCT01754246|"~     The purpose of this study is to assess treatment for facial skin toning and removal of~     epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser~   "
99537|NCT01754233|"~     The purpose of this study is to assess treatment for facial dermal and epidermal pigmented~     lesions using the 755nm Alexandrite laser.~   "
99538|NCT01754220|"~     Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment~     of chronic cough and this could be made objective by measuring cough threshold before and~     after two weeks of treatment.~   "
99539|NCT01754207|"~     The purpose of this study is to collect further data on the safety and efficacy of removing~     unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.~   "
99540|NCT01754194|"~     Study objectives:~        1. generate local clinical, health-related quality-of-life and health economic data to~          evaluate the benefits of two types of minimally invasive weight-loss surgery~        2. support multi-disciplinary bariatric sites in Germany by providing structured procedure~          guidelines and training, therefore facilitating procedural adoption, increasing safety~          and shortening the learning curve for weight-loss surgery.~   "
99541|NCT01754181|"~     The main objective is to assess if the Diabeloop algorithm provides better glycemic control~     than a manual usual algorithm of patients with type 1 diabetes treated by insulin pump~     during meals, and during activity qualified moderate to severe by the patients.~      The study will be conducted in 18 patients. The investigation centers are: CHSF (for~     Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for~     Diabeloop algorithm test during meals.~   "
99542|NCT01754168|"~     The investigators propose to study persons with Parkinson Disease (PD) with detailed~     clinical, cognitive and imaging at the time of study entry and repeat these assessments 2~     years later. The study looks at how changes in activity of the neurotransmitter~     acetylcholine relates to changes in cognitive function and to see if there is presence or~     build up of amyloid protein.~   "
99543|NCT01754155|"~     The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome~     measures to evaluate early, post-operative implant stability, post-operative implant~     fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin~     E stabilized polyethylene.~   "
99545|NCT01754129|"~     In patients with advanced levodopa-responsive Parkinson's Disease and severe motor~     fluctuations despite optimized treatment with conventional oral Parkinson's Disease~     medications, treatment with Duodopa represents an alternative treatment option to improve~     motor, non-motor performance and overall quality of life. These benefits have been obtained~     in short and mid-term trials (mainly up to 2 years). Data on long-term effectiveness (5~     years of treatment or more) and safety are not available. Also data concerning the benefit~     of Duodopa on cognitive function, axial symptoms and disability have to be confirmed. Recent~     data on deep brain stimulation (DBS), the alternative option treatment in advanced~     Parkinson's Disease patients, showed that after 5 years from the implant, a worsening of~     axial symptoms (gait and balance) and after 1 to 3 years of speech could occur. Moreover, it~     has never been assessed if the benefit on motor and non-motor symptoms in patients treated~     with DUODOPA could be influenced by age and duration of the disease, as already shown for~     DBS implanted patients. This study should clarify the missing information on long-term~     benefit of Duodopa (up to 7 years) especially focusing on motor fluctuations and disability.~   "
99546|NCT01754116|"~     This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult~     subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg~     intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This~     study will evaluate LAP formulations of GSK1265744 with different particle sizes.~      Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400~     mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um~     by intramuscular injection. Samples for determination of GSK1265744 concentrations will be~     collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording~     and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects~     will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last~     day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A~     enzymes.~      The subjects will undergo follow-up evaluations for a minimum of 12 weeks.~   "
99547|NCT01754103|"~     Brain plasticity of cortical activity caused by repetitive tactile stimulation could have a~     progressive development that was from primary parietal areas, passing over parieto-occipital~     areas and came secondary to primary occipital areas. This process allows to understand the~     existence of neurons in the brain and specific areas for certain functions independent of~     the type of stimulation is performed.~      By performing repetitive tactile stimulation over a period of 3 months,using a tactile~     stimulator, our group will try to prove several that repetitive tactile stimulation can~     create cross-modality and improve recognition and localization of patterns in blind people.~   "
99548|NCT01754090|"~     The purpose of this study is to test whether an online multi session alcohol intervention~     improves treatment effect compared to single session screening with feedback only.~      All participants in the trial received a single session screening procedure including~     individualized normative feedback (usual care). Additionally, half of the participants~     received a simple online booklet about the effects of alcohol. The other half received an~     online multi session follow up program.~   "
99549|NCT01754077|"~     The purpose of the proposed research is to evaluate the Thirty Million Words (TMW)~     Intervention through a randomized, controlled pilot study. The primary goal of the~     intervention is to enrich the early language learning environment of children from~     low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult~     word input and conversational turn taking. The investigators hypothesize that receiving the~     TMW intervention will result in changes in parent behaviors.~   "
99550|NCT01754064|"~     SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of~     patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management~     (CRM) products. This registry will be conducted in the United States (US).~      The primary purpose of the registry is to evaluate and publish acute and long-term~     performance of market-released SJM CRM products by analyzing product survival probabilities.~     Product status and any related adverse events will be collected to measure survival~     probabilities.~   "
99551|NCT01754051|"~     This study is a prospective, multi-center registry of patients with intracranial aneurysms~     who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3~     months post-procedure for the study.~   "
99552|NCT01754038|"~     This registry will perform prospective surveillance of participants attending collaborating~     Integrative Medicine clinic sites for clinical services. All decisions about medication use,~     treatments, visit frequency, assessment of tolerance, and other aspects of patient~     management will be left to the clinical providers' discretion. We will attempt to follow the~     participants in the PRIMIER Registry for up to 2 years.~      Essential data elements that capture patient-reported outcomes and measures of clinical~     activity will be obtained at approximately 2-month intervals for the first 6 months, then~     every 6 months through the end of year 2.~   "
99553|NCT01754025|"~     Lung cancer is a common malignancy that is associated with cigarette smoking but can also~     affect individuals who never smoked. It is not well understood whether there are hereditary~     risk factors that influence the risk of lung cancer.~      It has been recently found that a small number of families have an inherited (passed from~     parent to child) change in one of their genes that may contribute to an increased tendency~     to develop lung cancers, even in never smokers. In some lung cancer patients this gene,~     called EGFR, contains a DNA change known as an inherited EGFR mutation. Early data~     indicate that these inherited EGFR mutations may be associated with an increased risk of~     lung cancer.~      So far, only a small number of families have been found to carry inherited EGFR mutations.~     For this reason the risk of lung cancer associated with inherited EGFR mutations is not well~     understood. Understanding the risk may help investigators find ways of detecting lung cancer~     sooner or reducing the risk of developing lung cancer.~      It was recently discovered that lung cancer patients who are found to carry one rare EGFR~     mutation in their cancer cells, called T790M, have an increased risk of carrying an~     inherited EGFR mutation in their normal cells as well. This represents a new strategy for~     finding individuals and families carrying inherited EGFR mutations.~      This research study is designed to find cancer patients whose tumors have this EGFR~     mutation, T790M, to find out if they also have an inherited EGFR mutation. Subjects will not~     have to undergo a biopsy to participate in this research study. Investigators will collect a~     saliva specimen from patients with a T790M in their cancer to find out if they also have an~     inherited EGFR mutation.~      Study participants found or known to carry an inherited EGFR mutation will have the option~     of offering their close relative the opportunity to also participate in this study. Close~     relatives can consider testing to see if they also carry the inherited mutation in their~     normal cells. Once investigators have identified individuals and relatives that carry~     inherited EGFR mutations in their genes, investigators will then try to understand the risk~     of lung cancer and other cancers. Individuals with inherited EGFR mutations will also have~     the opportunity to participate in future studies related to cancer and other diseases.~      This study is being funded in part by the Conquer Cancer Foundation of ASCO and the Bonnie~     J. Addario Lung Cancer Foundation.~   "
99598|NCT01753440|"~     The aim of the present study is to investigate safety and efficacy of intramyocardial~     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy~     at the time of coronary artery bypass grafting.~   "
110977|NCT01603641|"~     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the~     treatment of pediatric lower limb spasticity.~   "
99554|NCT01754012|"~     NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving~     nutritionists, bio-gerontologists, immunologists and molecular biologists from the most~     prestigious institutions in Europe, 5 large food industries, 8 traditional food companies~     and 1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13~     European countries and the European Confederation the food and drink industry. NU-AGE aims~     are: 1. to counteract the physical/cognitive decline occurring in the elderly as a~     consequence of the progressive alteration of different organs/systems (immune and~     cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored~     whole diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet,~     half control) from 5 different EU regions; 2. to assess the effect of the newly designed~     food pyramid specific for 65+ EU citizens on the different organs/systems using a large set~     of biomarkers related to nutrition and aging, with particular attention to the low grade,~     chronic, systemic inflammatory status named inflammageing, a major risk factor for common~     age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high~     throughput omics to identify cellular/molecular targets/mechanisms responsible for whole~     diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual~     variability on the response to diet; 5. to adopt an integrative comprehensive approach~     (systems biology) to analyze the whole set of data. The results of dietary intervention will~     be used to develop elderly-tailored prototypes of functional foods and to improve~     traditional foods. The research activity will be accompanied and followed by a strong~     activity of dissemination and industrial exploitation to support EU strategies on~     nutritional recommendations, thus contributing to the implementation of legislation related~     to nutritional and health claims for elderly in Europe.~   "
99555|NCT01753999|"~     The goal of the study is to examine the possible underlying causes of sleep apnea (a~     disorder in which there are problems with breathing during sleep) in World Trade Center~     Responders. The study will look at the relationship between sleep apnea and various nose and~     throat conditions. Specifically, the study will look at upper airway disease (problems with~     the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow~     through the nose). Subjects will have a physical exam and answer questions about nasal~     symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be~     performed on the subjects and markers of inflammation will be measured in the lavage fluid.~     Rhinomanometry (measuring the airflow through the nose) will also be performed to measure~     the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea~     monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment~     methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure)~     device. This device blows air into a mask worn by the patient during sleep. The two~     treatment methods that will be tested are the fixed pressure CPAP (pressure is constant~     during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be~     randomly assigned to one treatment method for one month then crossed to the other treatment~     method for the next month. The investigators will determine if patients with certain nasal~     conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.~   "
99556|NCT01753986|"~     The investigators hypothesize that individuals receiving the brief substance use~     intervention will have better substance use and intimate partner violence outcomes than~     individuals receiving the general health improvement intervention. All participants receive~     standard batterer intervention.~   "
99557|NCT01753973|"~     Metabolic syndrome (MS) is characterized by a series of metabolic and hemodynamic parameters~     such as hypertension (hypertension), abdominal obesity, dyslipidemia, abnormal glucose~     metabolism and insulin resistance, resulting in increased cardiovascular morbidity and~     mortality and the risk for developing type 2 diabetes mellitus (T2DM). Metabolic syndrome is~     a common event after renal transplantation. The prevalence of MS increases post-transplant~     with weight gain. In renal transplant recipients, the SM is associated with CVD, diabetes~     after transplantation, worsening renal function and graft loss. Immunosuppressant~     medications have primary effect on the pathophysiology of MS. Several studies have evaluated~     the prevalence and impact of metabolic syndrome in renal transplant recipients as obesity,~     hypertension, dyslipidemia and use of immunosuppressants. The objectives of this study are~     to determine whether the determination of the metabolic syndrome at 6 months predicts this~     same condition at 12 months, determine the prevalence of metabolic syndrome at 12 months, to~     assess the prevalence of obesity and overweight in this population and to assess the~     prevalence of diabetes mellitus after renal transplantation. Patients who meet the inclusion~     criteria and did not meet the exclusion criteria will be invited to participate in the~     study, signing the Instrument of Consent (IC) and informed about the objectives and~     procedures of the study to be performed, with age between 18 and 60 years, both sexes, renal~     transplant recipients Renal Transplant Unit, Hospital das Clinicas, FMUSP living donor or~     deceased and use of immunosuppressive regimen consisting of tacrolimus, mycophenolate sodium~     and prednisone. Sampling will be conducted laboratory tests, filling out questionnaires on~     quality of life and anthropometric measures.~   "
99558|NCT01753960|"~     The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin~     Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making~     algorithm in the operating room.~   "
99559|NCT01753947|"~     Training on simulated models in a surgical skills laboratory has been shown to improve~     technical performance in the operating room. Currently described simulation-based curricula~     consist of trainees practicing the same tasks until expert proficiency is reached. It has~     yet to be investigated whether individualized deliberate practice, where curricula tasks~     vary depending on prior levels of technical proficiency, would translate to the operating~     room.~      This randomized controlled trial effectively demonstrates that deliberate practice on a~     virtual reality simulator results in an improvement in technical skills in a real clinical~     situation. This enhances the feasibility of implementing simulation-based curricula into~     residency training programs, and consequently has the potential to improve patient safety.~   "
99560|NCT01753934|"~     About the Study: This research study is being conducted to see if diabetic ketoacidosis has~     any impact on learning, behavior and development in children with Type 1 diabetes mellitus.~     If there is an impact, is it transient or persistent? Sixty to 80 children between the ages~     of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a~     non-sedated MRI scan of the head performed. The investigators will compare this to a control~     group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.~     The children with Type 1 diabetes mellitus will not have any changes made to their current~     diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood~     glucose values as required by your doctor and bring their meter(s) for downloading to each~     visit. The children with Type 1 diabetes mellitus should also tell your doctor about the~     frequency of severe low and high blood glucose values.~   "
99561|NCT01753921|"~     This is a research study to understand how diabetic ketoacidosis may affect the brain and~     learning and to see if these changes are transient or permanent. The investigators hope to~     learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing~     a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™~     (NNS), learning, talking, behavior, or development. The investigators will compare those~     results from those with diabetes mellitus to those age and gendered matched healthy~     controls. Possible subjects in this study have diabetes mellitus and are between the ages of~     10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less~     than 17 years old.~   "
99562|NCT01753908|"~     This randomized pilot trial studies broccoli sprout extract in treating patients with breast~     cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of~     certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract~     may help determine if it can enter breast tumor cells and how it affects certain biomarkers.~   "
99563|NCT01753895|"~     Blood pressure (BP) measurement is one of the most commonly performed screening tests in the~     clinical setting. Its accuracy is vital to the early diagnosis and effective management of~     hypertension, as emphasized by hypertension management guidelines. For most protocols being~     conducted in a clinical research setting, obtaining single or serial blood pressure~     reading(s) is often performed as a safety assessment, especially if the individual is~     participating in a study that requires a blood draw and/or the administration of a research~     drug, vaccine or device. It is imperative that the blood pressure data truly reflect the~     response, if any, the study participant experiences in relation to the research procedures~     and interventions.~   "
99564|NCT01753882|"~     The primary goal of the proposed clinical trial is to investigate the combined effects of~     walking training and monoaminergic agents (SSRIs and TIZ) on motor function of individuals~     in sub-acute (2-7 mo) human motor incomplete Spinal Cord Injury (SCI), with a primary~     emphasis on improvement in locomotor capability. We hypothesize that the use of these drugs~     applied early following SCI may facilitate independent stepping ability, and its combination~     with intensive stepping training will result in improved locomotor recovery following~     incomplete SCI. Loss of descending control via norepinephrine inputs following spinal cord~     injury can impair normal sensorimotor function through depressing motor excitability and~     impairing walking capacity. Replacing these inputs with drugs can alter the excitability and~     assist with reorganization of locomotor circuits. Assessment of single-dose administration~     of these agents has been tested in patients with motor incomplete spinal cord injury; only~     limited changes in walking performance have been noted. The resultant onset of weakness and~     increase in involuntary reflexes following motor incomplete SCI may partly be a result of~     damage to descending pathways to the spinal cord that control the release of serotonin. In~     models of SCI, for example, application of agents that simulate serotonin has been shown to~     change voluntary motor behaviors, including improvement of walking recovery. In humans~     following neurological injury, the effects of 5HT agents are unclear. Few previous reports~     indicate improved motor function following administration of agents which enhance the~     available serotonin in the brain, although some data suggests that increased serotonin may~     be beneficial. In this application, we propose to study the effects of clinically used~     agents that increase or decrease intrinsic serotonin activity in the brain on strength and~     walking ability following human motor incomplete SCI. Using detailed electrophysiological~     recordings, and biomechanical and behavioral measures, we will determine the effects of~     single or chronic doses of these drugs on voluntary and involuntary motor behaviors during~     clinical measures and walking measures. The novelty of this proposed research is the~     expectation that agents that increase serotonin activity may increase abnormal reflexes in~     SCI, but simultaneously help to facilitate motor and walking recovery. Despite potential~     improvements in voluntary function, the use of pharmacological agents that may enhance~     spastic motor behaviors following SCI is in marked contrast to the way in which drugs are~     typically used in the clinical setting.~   "
99565|NCT01753869|"~     Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF)~     with 80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway~     clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists~     use different techniques to help clear mucus from the lungs of patients with CF. Inhaled~     medications and airways clearance techniques (ACTs) are central to a CF patient's daily~     treatment and are often coordinated.~      Burden of treatment is a common reason for non-adherence in this patient group, and~     streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy~     to an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in~     the research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the~     daily regimen. A study to show whether the timing of HTS around ACT is significant, can~     better inform patients and potentially allow more flexibility around their treatment~     regimen.~      Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function~     compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be~     a suitable tool therefore, to assess intervention strategies aimed at airways clearance in~     CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS~     inhalation as measured by LCI.~      It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during~     HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment~     of a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment~     session options on the first day and the reverse on the second day.~      The primary objective of this study is to compare the change in LCI (a measure of lung~     function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs~     during HTS inhalation in adult CF patients.~      LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)~   "
99566|NCT01753856|"~     The purpose of this study is to determine how teriparatide or denosumab affects the bone of~     postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone~     biopsy sample taken from the iliac crest (upper part of the pelvis).~   "
99567|NCT01753843|"~     RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early~     cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm~     (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants~     (n.a.p.i.) at 37 weeks of post conceptional age~   "
99568|NCT01753830|"~     The purpose of the study is to determine whether a single intra-articular injection of~     Durolane is superior to a single injection of PBS for the relief of joint pain in patients~     with osteoarthritis of the knee.~   "
99569|NCT01753817|"~     Radial artery occlusion may occur after performance of coronary catheterization via the~     radial artery (transradial approach). In some cases it may be desirable to insert large (7F)~     catheters via the radial artery, however the impact of increased catheter size on subsequent~     radial artery patency is unclear. We hypothesize that radial artery occlusion following 7F~     catheterization is rare and occurs in < 5% of the cases.~   "
99570|NCT01753804|"~     To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to~     help inform the design of future studies, to capture biomarkers of safety and disease~     progression and to provide comparative data for the development of rare exons for which~     formal controlled trials are not feasible.~   "
99571|NCT01753791|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     PF-06473871 in normal healthy adults.~   "
99572|NCT01753778|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III Device for temporary relief of pain.~   "
99573|NCT01753765|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III device for temporary relief of or reduction in pain due~     to occipital neuralgia.~   "
103729|NCT01699373|"~     A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with~     manual palpation to identify landmarks for performance of spinal anaesthesia.~   "
99574|NCT01753752|"~     In the elderly population, dry eye syndrome is a highly prevalent ocular disease. One~     mainstay of therapy for patients suffering from dry eye syndrome is the use of topically~     administered lubricants. One of the main disadvantages of the formulations currently~     available for the treatment of DES is the short residency time on the ocular surface, which~     increases the need for a frequent instillation of the lubricant.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Based on theoretical considerations and animal~     experiments, the new chitosan derivative may show an increased adhesion to mucins of the~     ocular surface and may therefore considerably increase the residence on the ocular surface.~     This, in turn, would limit the need for frequent treatment and decrease the burden for the~     patients.~      It has been shown in recent Phase I studies that chitosan-N-acetylcysteine eye drops are~     safe and well tolerated after single and repeated instillation. The current study seeks to~     investigate the ocular residency time after a single dose and after 5 day b.i.d. treatment.~     For this purpose 2 cohorts are planned: In Cohort I, chitosan-N-acetylcysteine eye drops~     will be instilled once in one randomly chosen eye, whereas the fellow eye will receive~     placebo. Measurements of tear film thickness will be performed with optical coherence~     tomography (OCT) before instillation and 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10~     hours, 12 hours and 24 hours after instillation. In addition, ocular scattering of the tear~     film will be assessed with an Optical Quality Analysis System (OQAS) at the same timepoints.~     Determination of break up time (BUT) will be performed before and after instillation of the~     eye drops.~      In Cohort II, chitosan-N-acetylcysteine eye drops will be instilled once daily in one eye~     and b.i.d. in the fellow eye on five consecutive days. Measurements of tear film thickness~     with OCT and OQAS will be performed every study day before the morning instillation and the~     day after the last instillation. Additionally, patients will be asked to answer the ocular~     surface disease index (OSDI©) on day 1 and day 6. BUT will be determined before and after~     instillation of the eye drops.~   "
99575|NCT01753739|"~     This study will examine dose ranging characteristics of bepotastine besilate nasal spray~     compared to placebo nasal spray in 600 male or female subjects 12 years of age and older~     with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic~     sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.~   "
99576|NCT01753726|"~     Physical therapists have traditionally included various forms of manual therapy among the~     therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the~     effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.~   "
99577|NCT01753713|"~     This phase II trial studies how well dovitinib works in treating patients with recurrent or~     progressive glioblastoma. Dovitinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth~   "
99578|NCT01753700|"~     The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk~     on bloodlipid profile~   "
99579|NCT01753687|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory~     response of the ocular surface. Common symptoms include ocular discomfort, visual impairment~     and instability of the tear film with potential damage to the ocular surface.~      The rationale of the present study is to compare signs as assessed with new methods such as~     measurement of tear film thickness, tear film osmolarity and scattering of the tear film~     with well established methods for assessment of the severity of DES (Break up time, staining~     of the cornea with fluorescein). Additionally, impression cytology and determination of tear~     cytokines/chemokines will be performed to obtain information about inflammatory processes on~     the ocular surface.~   "
99580|NCT01753674|"~     Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance~     and plasma glucose in individuals classified with metabolic syndrome.~   "
99581|NCT01753661|"~     The purpose of the proposed exploratory research protocol is to investigate the feasibility~     and efficacy of Project ASPIRE, a parent-directed intervention aiming to increase parental~     skills and enrich children's early language environments and ultimately improve child~     outcomes in children with hearing loss from low-income backgrounds.~   "
99582|NCT01753648|"~     Recently, a new and sophisticated method for assessment of retinal blood flow and retinal~     blood flow velocity profiles has become available. This technique is based on the~     combination of measurement of retinal vessel calibers with bidirectional Fourier domain~     optical coherence tomography (FDOCT). The valid measurement of retinal blood flow is of~     significant importance, because it is known that major ophthalmic diseases, such as~     hypertensive retinopathy, are associated with alterations in blood flow.~      Hypertensive retinopathy is the most common manifestation of arterial hypertension in the~     eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by~     vasospasms and increased vascular tone. Further in the disease process, focal arteriolar~     narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous~     studies have shown that blood flow in the extraocular vessels and in the choroid is~     compromised in patients with arterial hypertension. However, data on the impact of arterial~     hypertension on retinal blood flow and retinal blood flow velocities are lacking.~      The present study sets out to compare total retinal blood flow and retinal velocity profiles~     in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular~     perfusion pressure will be calculated based on measurements of blood pressure and~     intraocular pressure to allow for calculation of vascular resistance. In addition, velocity~     profiles at arterio-venous crossings will be measured. It is hypothesized that these~     velocity profiles are considerably modified in patients with stage 2 and 3 hypertensive~     retinopathy compared to healthy controls because of pronounced arterio-venous compression.~   "
99583|NCT01753635|"~     The purpose of this study is to compare the performance of the Baska mask supraglottic~     airway device with a single use laryngeal mask device (LMA) in low-risk female patients.~      The investigators have performed a number of studies on novel airway devices, including 3~     studies on the Baska mask. This trial will compare some performance characteristics of the~     studied devices, including airway seal pressures, insertion success rates, device use~     difficulty scores. Additional performance and device safety data will be accumulated.~      The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement~     attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask~     vs LMA.~   "
99584|NCT01753622|"~     Obesity and overweight have become an epidemic in the world and its prevalence between~     pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also~     associated with depression disorders and its serious complications during this period.~   "
99585|NCT01753609|"~     The study will assess the safety and performance of an intragastric auto-inflating and~     degradable balloon~   "
99599|NCT01753427|"~     The objective of the study is to assess patient's perception with stable state COPD on~     symptom variability and to describe how symptom variability impacts daily quality of life in~     Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3~     hospitals in China where most of COPD patients are diagnosed and treated.~   "
99671|NCT01752491|"~     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate~     (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma~     multiforme (GBM).~   "
99586|NCT01753596|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for~     the patients reaching from ocular discomfort in its simplest form up to visual impairment~     and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES~     is a common disease, especially in the elderly population, affecting up to 20% of adults~     aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect~     on tear film thickness and the corneal residence time are lacking.~      Recently, a new objective method for assessment of tear film thickness by optical coherence~     tomography has been developed. The present study aims to investigate the corneal residence~     time of an established topical lubricant compared to placebo in patients with DES and~     healthy controls.~   "
99587|NCT01753583|"~     Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical~     practice. The current study seeks to investigate whether high-resolution OCT is suitable for~     imaging of these corneal lesions. The present study has the character of a pilot study and~     the results are intended to be used to develop a standardized protocol for imaging and~     analysis of these corneal lesions. Based on this protocol, further studies investigating the~     pathophysiology of corneal lesions or evaluating therapeutic success can be planned.~   "
99588|NCT01753570|"~     This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients~     with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment~     before.~   "
99589|NCT01753557|"~     This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in~     patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after~     previous treatment.~   "
99590|NCT01753544|"~     We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic~     submucosal dissection of gastric neoplasia.~   "
99591|NCT01753531|"~     The clinical performance of the Ultra Influenza A&B Test will be demonstrated during a~     clinical trial in which prospectively collected nasal swabs are used in identifying subjects~     who are infected with the influenza virus strain type A or type B. The Ultra Influenza A&B~     Test qualitative results will be compared to Gold Standard viral culture with Direct~     Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from~     symptomatic subjects. The Ultra Influenza A&B Test will be performed at Clinical Laboratory~     Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses,~     physician assistants, medical assistants, etc.). For viral culture testing with DFA~     confirmation testing, nasal swab specimen testing will be performed by a designated~     reference laboratory.~   "
99592|NCT01753518|"~     Currently, the way doctors close the skin during cesarean section is different between~     surgeons and there is little evidence to support the use of one kind of closure over the~     other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable~     suture (or stitch), placed within the top layer of skin. At other institutions, a metal~     staple is often used to close the skin.~      There is a new technique that uses special absorbable staples just beneath the skin. This~     technology may be equal to, or possibly better than, current skin closure techniques.~     However, there is currently little data to show how it compares. The purpose of this study~     is to compare the absorbable staple to the currently used absorbable suture. The data from~     this study will then be used to help determine the best technique for skin closure.~   "
99593|NCT01753505|"~     The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector~     coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary~     artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary~     artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed~     noninvasively with similar accuracy of coronary angiography using MDCTA. Early detection and~     intervention of CAD may provide survival benefit in renal transplant recipients.~   "
99594|NCT01753492|"~     Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma.~     Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to~     prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular~     blebs, and increased risk to infection, blebitis and endophthalmitis.~      Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant~     (Ologen), has become available for glaucoma surgery.Although a few studies on filtering~     surgery with Ologen implantation have been performed, there is yet no conclusive evidence on~     effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.~      This is a prospective intervention pilot study to determine the degree of intraocular~     pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to~     trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of~     the two procedures will be compared.~      The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than~     trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.~   "
99595|NCT01753479|"~     Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to~     adenocarcinoma patients.~   "
99596|NCT01753466|"~     The investigators are conducting a six-week randomized controlled pilot trial to assess the~     feasibility and safety of increased water intake in patients with chronic kidney disease.The~     investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration~     rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8~     mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in~     a 2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized~     to the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day~     (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks.~     Participants in the control group will be advised to consume their usual amount of fluid.~      The investigators hypothesize that patients will be able to increase and maintain a higher~     fluid intake with stable blood chemistry, particularly serum sodium.~   "
99597|NCT01753453|"~     The primary objective of this study is to evaluate tumor cell mobilization (TCM) with~     non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with~     multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).~      Second objectives are to evaluate survival and disease status of G-CSF alone compared with~     GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to~     mobilize stem cells for autologous transplantation.~   "
99601|NCT01753401|"~     This Phase 4 study is being performed to examine the effects of Acthar for the indicated use~     of treatment of SLE. This study will enroll patients with steroid-dependent, persistently~     active SLE with arthritic and/or cutaneous involvement. The study will involve two phases: a~     double-blind phase, to provide placebo-controlled safety, efficacy, and pharmacodynamic~     data, and an optional open-label phase, to examine the prolonged effects of Acthar~     maintenance.~   "
99602|NCT01753388|"~     The purpose of this study is to assess the safety and performance of the Penumbra Liberty~     Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial~     aneurysms.~   "
99603|NCT01753375|"~     Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical~     cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing~     relapses and disease progression, prospective randomized control trials are nevertheless~     necessary to confirm these statements and to determine the most efficacious, safe, and the~     minimum required doses. This hypothesis is going to be tested through a randomized triple~     blinded controlled trial in which after randomization, one group of patients will receive~     vitamin D and second group will receive placebo. Both groups are going to be followed in a~     similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D~     levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the~     beginning and end of trial.The number of relapses and the physical disability will be~     calculated through the Expanded disability status scale (EDSS).~   "
99604|NCT01753362|"~     The purpose of this study is to examine the effects of liraglutide (a drug used to treat~     type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in~     addition to insulin.~   "
99605|NCT01753349|"~     The purpose of the study is to document long-term response in real-life practice after~     injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia~     (Long-term clinical and pharmaco-economic data).~   "
99606|NCT01753336|"~     The purpose of the protocol is to assess the long term safety of repeat treatment cycles of~     Dysport 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an~     extension study to study A-TL-52120-169 (hereafter referred to as Study 169).~   "
99607|NCT01753323|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400~     mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)~   "
99608|NCT01753310|"~     The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution~     compared with placebo for the treatment of Cervical Dystonia.~   "
99609|NCT01753297|"~     The purpose of this study is to assess the benefit of immediate hormonal treatment after~     Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To~     reach this target, the trial will compare a group of patients treated with triptorelin at 8~     weeks after the surgery and for a duration of 9 months (3 injections) versus another group~     (called active surveillance group) who will be not receiving triptorelin. Both groups will~     be followed every 3 months to monitor any sign of disease progression during a minimum of 36~     months~   "
99610|NCT01753284|"~     First episode psychosis patients often experiences treatment delay. This reduces their~     prospects for recovery and makes unnecessary burdens for them and their carers. A better~     understanding of help seeking intentions is required, and has not been explored in a county~     like Nordland, Norway, with long distances and challenging access to health services. The~     purpose of this study is to explore the process of help seeking, including how patients and~     their careers discover and understand the psychotic symptoms. Research exploring the impact~     on families mainly focuses on parents` experiences, and there are less studies focusing on~     experiences and needs of siblings. This study will therefore explore siblings` experiences~     separate from their parents. Methods will be qualitative interviews with patients, their~     carers and siblings. Analysis will be influenced by Grounded theory.~   "
99611|NCT01753271|"~     Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic~     spinal manipulation in addition to shoulder mobilization and exercise for improving range of~     motion, pain, physical function and fear avoidance beliefs in patients with subacromial~     shoulder impingement.~      Hypotheses It is hypothesized that those subjects who receive spinal manipulation in~     addition to shoulder mobilization and exercise will achieve greater improvements in range of~     motion, pain, function and fear avoidance beliefs at two weeks following treatment~     conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the~     subjects who did not receive the spinal manipulation.~   "
99612|NCT01753258|"~     The focus of this pilot study is to determine if a woman who experiences pain during sexual~     intercourse has a higher risk of complications during labor and delivery secondary to pelvic~     floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is~     unclear whether women with prepartum dyspareunia experience an improvement following vaginal~     delivery. While physicians may expect that vaginal birth improves dyspareunia due to the~     stretching effect on pelvic floor, to date, there is insufficient evidence to support this~     claim. The Investigators plan to prospectively study 200 patients at our Institution,~     collect information regarding birth and follow them, via questionnaires, regarding their~     dyspareunia postpartum.~   "
99613|NCT01753245|"~     It has been reported in various epidemiological studies that patients with~     moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an~     increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2~     diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial~     dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could~     explain the higher prevalence of cardiovascular disease and mortality observed in this~     population. Existing evidence showing improvement in psoriasis after correcting some~     factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate~     markers of cardiovascular risk with different modalities of psoriasis treatment suggest a~     biological interaction between the two diseases beyond mere epidemiological association.~     Recently published results support this hypothesis and suggest that the link between~     psoriasis and cardiovascular disease could be the existence of an inflammatory state in~     different organs, including skin, joints, adipose and hepatic tissue, and vascular~     endothelium (16). Patients with MetS have an increased risk of developing T2DM and~     cardiovascular disease. This syndrome is characterized by the association of an adipose~     tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new~     mechanism participating in the development of MetS has been added: the Wnt signaling~     pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with~     metabolic abnormalities that predispose to cardiovascular disease, the development of~     moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and~     response to treatment with anti-TNF-alpha.~      This study aims to describe the cardiovascular risk factors of a Spanish population of~     patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic~     arthritis,treated with anti-TNF under routine clinical practice conditions. Possible~     differences in efficacy relative to the presence or absence of criteria of metabolic~     syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory~     activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment~     during the first year.~   "
99614|NCT01753232|"~     Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a~     patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and~     then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole~     blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The~     MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with~     plasma which is cleaned by filtration. This study comprises the recording of safety and~     efficacy data from patients treated either with the DALI or MONET-system over a period of 2~     years.~   "
99615|NCT01753219|"~     The objective of this study is to evaluate chronic pain and sexual dysfunction after~     inguinal hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no~     mesh fixation (Onstep). The study hypothesis is that a smaller proportions of patients~     operated without mesh fixation (Onstep) will have chronic pain that impairs daily function.~   "
99616|NCT01753206|"~     Study Objectives The study is to identify prevalence, demography and clinical~     characteristics of patients with resistant hypertension among hypertensive patients who have~     been treated in general hospitals in Korea from Jan 2012 to Jun 2012.~        -  Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the~          boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg~          (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or~          chronic renal disease) despite triple antihypertensive therapy at optimal dose may be~          diagnosed as resistant hypertension. Antihypertensive medications used include~          diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has~          reached the target value but quadruple or more of antihypertensives are used.~        -  Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to~          140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or~          less with the administration of antihypertensives at optimal dose may be diagnosed as~          controlled hypertension.~   "
99617|NCT01753193|"~     The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with~     moderate to severe active systemic lupus erythematosus~   "
99618|NCT01753180|"~     A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study,~     evaluating acute intra-coronary injected collagenase prior to routine standard-of-care~     percutaneous revascularization procedures in subjects with chronic total coronary artery~     occlusions (CTOs).~   "
99619|NCT01753167|"~     This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess~     the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in~     cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive~     donor, with use of a preemptive approach for prevention of CMV disease. Participants will be~     randomized into two treatment groups: active or placebo control; both arms will be followed~     preemptively. The study has a planned enrollment of approximately 120 participants (60~     active and 60 placebo).~   "
99620|NCT01753154|"~     To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in~     comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients~     using the APD cycler sleep•safe.~   "
99621|NCT01753141|"~     The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused~     on helping people manage their anxiety while quitting smoking. The study involves coming in~     to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2,~     month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50~     for their full participation as well as receive 6 weeks of free nicotine replacement~     patches.~   "
99622|NCT01753128|"~     Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease~     (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic~     antidepressant improves NERD patient's symptoms remains unknown~      Aim of this randomized controlled trial study is to determine the efficacy of imipramine,~     which could increase esophageal pain thresholds in healthy volunteers, in comparison with~     placebo for treatment patients with esophageal hypersensitivity or functional heartburn~     evaluated by improvement of specific-symptom score and quality of life~   "
99623|NCT01753115|"~     The purpose of this clinical trial is to determine whether there is any effect on the~     antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of~     BioThrax® (Anthrax Vaccine Adsorbed or AVA).~      This study will be conducted in the United States (US) in 154 healthy male and female~     volunteer subjects ages 18 to 45.~      The duration of study participation for each subject will be approximately 76 days~     (approximately 2.5 months)~   "
99624|NCT01753102|"~     Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing~     17ß-estradiol.~      The estradiol in estradiol vaginal tablet is chemically and biologically identical to the~     endogenous human estradiol and is therefore classified as a human estrogen.~      The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's~     Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is~     approved and marketed in the US.~   "
99634|NCT01752972|"~     Patients of arsenical keratosis may be treated with spirulina. Is this improvement related~     to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To~     understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls~     (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally~     for 12 weeks. Skin extracts will be collected both before and after supplementation from the~     palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.~   "
99635|NCT01752959|"~     In this prospective randomized study we aimed to compare the effects of esmolol and~     remifentanil on intraoperative bleeding surgical field conditions in nasal surgery~   "
99636|NCT01752946|"~     The purpose of this study is get to know what and how Shuxuening injection in hospital~     results in adverse events or adverse drug reactions from a cohort event monitoring.~   "
99637|NCT01752933|"~     A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced~     hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a~     Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at~     16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease~     control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC~     after failure of prior sorafenib.~   "
99625|NCT01753089|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     investigational melanoma vaccines. Phase I studies also try to define the appropriate dose~     of the investigational vaccine, in this case WDVAX, to use for further studies.~     Investigational means that the vaccine is still being studied and that research doctors~     are trying to find out more about it. It also means that the FDA has not yet approved WDVAX~     for any use in patients, including people with Melanoma.~      The purpose of this study is to determine if it is possible to make a vaccine against~     melanoma by using your own melanoma tumor cells and combining them with other proteins which~     activate the immune system. We hope that by combining the cells and the proteins in this way~     that the vaccine will cause your own immune system to react against your melanoma tumor~     cells. The purpose of this study is also to determine the safest way to give this vaccine~     with the least amount of side effects.~      Each vaccine will contain your own tumor cells which have been killed by a freezing and~     thawing process which destroys the cells but keeps the proteins from the melanoma cells.~     This is called a tumor lysate Your tumor lysate is combined with other proteins which~     activate the immune system. The other proteins are called GM-CSF and CpG. All of this is~     held together to form a tablet or scaffold which is about the size of a regular aspirin~     tablet. The material that holds the protein together is called PLGA. PLGA is the same~     material that doctors use for dissolvable stitches If you have ever had a problem with~     these types of stitches in the past, be sure to let your study doctor know about this.~   "
99626|NCT01753076|"~     This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel~     group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249)~     compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a~     screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive~     IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of~     48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of~     approximately 294 eligible subjects will be randomised from approximately 37 centers~     worldwide. The primary objective is to assess the effect of ozanezumab on the physical~     function and survival of ALS subjects over a treatment period of 48 weeks. Function will be~     measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives~     include the evaluation of other clinical outcomes associated with ALS (respiratory function,~     muscle strength, progression free survival and overall survival) in support of the primary~     objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics~     (ozanezumab and riluzole) will also be assessed.~   "
99627|NCT01753063|"~     As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task~     Force, this project will target patient and family expectations across the domains of~     nutrition, physical activity and behavior change/family support as a means of patient~     engagement and retention in pediatric weight management. This will be a prospective,~     non-randomized, uncontrolled, single-arm trial for children between 2 and 18 years of age~     and a parent/guardian, who are starting a pediatric weight management program/clinic in one~     of the participating centers. The parent/guardian and child if 12 years of age or older~     receive a survey at the first visit, which asks about their expectations and goals for the~     visit. This information will then be used as part of clinical care to tailor treatment.~     After 3 months, the parent/guardian and adolescent, if applicable, will receive a follow up~     survey asking about their progress in these areas.~   "
99628|NCT01753050|"~     Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery~     reduces morbidity and length of hospital stay. This quality improvement is design to~     evaluate the implementation of an intraoperative goal-directed therapy, using a pulse~     contour analysis monitor to optimize the stroke volume, in patients undergoing~     redo-hip-surgery. The primary combined endpoints will be the incidence of postoperative~     complications and the secondary endpoints will be the decrease of hospital length of stay,~     length of ICU stay and hospital postoperative mortality.~   "
99629|NCT01753037|"~     The hypothesis of this study is that DHEA administration to increase male hormone in healthy~     normal-weight young women to levels present in women with Polycystic Ovary Syndrome will~     cause an inflammatory response in white blood cells in the fasting state, and in response to~     glucose ingestion.~   "
99630|NCT01753024|"~     Malnutrition is a frequent problem in critically ill patients that is associated with~     detrimental clinical outcomes. To provide adequate nutritional support, current studies~     focused mostly on the choice of delivery timing, formula selection and the route of~     administration, little attention was paid to malnutrition related to exocrine pancreatic~     insufficiency (EPI).~      In fact, malnutrition is also a major consequence of pancreatic exocrine insufficiency and~     pancreatic damage is commonly observed in critically ill patients without prior pancreatic~     diseases. Hence, EPI associated malnutrition should be concerned due to the high prevalence~     of pancreatic damage in critically ill patients.~      The aims of this study is to evaluate the incidence of EPI in critically ill adult patients~     and explore its potential risk factors. Moreover, the efficacy of pancreatic enzyme~     supplementation therapy on malnutrition in ICU patients with specific clinical~     characteristics will be investigated.~   "
99631|NCT01753011|"~     This is a prospective, observational, multicenter study of women with surgically-correctable~     stress urinary incontinence who undergo a TOT-sling operative procedure.~   "
99632|NCT01752998|"~     Individuals will be recruited by posted advertisements in the waiting rooms of the PCP~     offices and by physician referral. After an initial phone screen, research staff will meet~     with interested individuals in their PCP offices for informed consent, baseline interview~     and randomization. Participants will be randomized into a Health Education study arm, and~     receive 7 individual sessions on general health education, or an Intervention study arm, and~     receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS)~     intervention.~   "
99633|NCT01752985|"~     The purpose of this study is to determine whether BMS-813160 will reduce the amount of~     protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease~   "
99638|NCT01752920|"~     This is an open-label, Phase 1/2, dose escalation and signal finding study of ARQ 087~     administered to subjects with advanced solid tumors with FGFR genetic alterations, including~     intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusion. The study is designed to~     explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary~     efficacy of ARQ 087 and to define a RP2D of ARQ 087.~   "
99641|NCT01752881|"~     The purpose of this study is to evaluate the antibody response to each of the three~     influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by~     hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and~     elderly subjects in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96).~   "
99642|NCT01752868|"~     The purpose of this study is to determine if a combination of 10 nutritional supplements~     provide health benefits that are consistent with protection against age-related disease. All~     supplements have been shown in previous studies to have health benefits when administered~     alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will~     provide beneficial changes in healthy related measures.~   "
99643|NCT01752855|"~     A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed~     to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed~     new adalimumab formulation.~   "
99644|NCT01752842|"~     This study will test whether lowering the delivery of excess fats to the heart in persons~     with type-2 diabetes mellitus improves heart muscle function. The investigators will also~     test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic~     heart disease.~   "
99645|NCT01752829|"~     The laparoscopic adjustable gastric band (LAGB) is a safe and effective surgical~     intervention for chronically obese patients who have exhausted all non-surgical weight loss~     treatments. Numerous published studies have confirmed both the safety and efficacy of the~     LAGB and its beneficial impact on obesity-associated conditions, such as type 2 diabetes,~     joint and back pain and hypertension. The A.M.I. Protector Band is a modification of an~     existing gastric band (the A.M.I. Soft Gastric Band) which has been in use since 2001 and~     which has been shown to be both safe and effective. The specific design modification is in~     the form of a section of mesh, which provides support to the gastric pouch and which further~     restricts food portion sizes. The expectation is that this will deliver optimal weight loss~     whilst having the maximum possible impact on obesity-associated conditions such as type 2~     diabetes and hypertension. In the longer term, there is also the possibility that the~     Protector Band will reduce the incidence of band complications such as slippage and~     dilatation (or stretching) of the gastric pouch. In this study we will recruit approximately~     200 patients who will then undergo surgical implantation of the A.M.I. Protector Band. The~     study participants will then be followed for a period of 3-years, during which time we will~     record weight loss, changes in co-morbid conditions such as diabetes and the incidence of~     band complications, including slippage and pouch dilatation.~   "
99646|NCT01752816|"~     In healthy young subjects a single bout of strength training following endurance training~     has been shown to improve markers for aerobic capacity in muscle compared to a single bout~     of endurance training alone. The present project tests the hypothesis: 12 weeks of training~     with sessions of endurance training followed by strength training is superior to endurance~     training alone for health participants 50-65 years of age. The outcome measures are maximal~     oxygen uptake and knee-extension strength.~   "
99647|NCT01752803|"~     Background: The connection between gut health and diabetes status is increasingly~     recognized. Gut microbiota composition in diabetic differs from non-diabetic individuals.~     Interestingly, the level of glucose tolerance was associated with specific microbiota that~     was rarely found in healthy individuals. Probiotics is one of the functional foods believed~     to mediate their health promoting activities through modulating the composition of the gut~     health. Ingestion of probiotics has been shown not only to influence gut microbiota~     composition but also the secretion of the gut hormones and insulin resistance in animal~     models with limited trials in human. Supplementation with probiotic has also been shown not~     only affect glucose homeostasis, but improved other diabetes related comorbidities such as~     obesity, hypertension, and hyperlipidemia.~      Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial~     (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant~     therapy to improve glucose homeostasis through modulating gut microbiota composition and gut~     hormones secretion in individuals with type 2 diabetes. We hypothesized that the probiotic~     supplementations will improve blood glucose control as well as other diabetes related~     co-morbidities in individuals with type 2 diabetes.~      Methodology: This is a double blind randomized parallel group control trial with 3 months~     probiotic supplementation or placebo. After screening the eligible subjects will be~     selected. Then, after consent taking, subjects will be randomly assigned to either receive~     probiotic or supplement for 3 months. Measurements of blood parameters including glycemic~     control related parameters, lipid profile, renal profile, and liver function tests as well~     as three day diet recall, and anthropometry measurements will take place at baseline, after~     6 weeks and after 12 months.~      Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose~     homeostasis and gut health as compared to the placebo and eventually will beneficially~     affect other diabetes related conditions. This study would provide avenue to identify the~     possibility of probiotic supplementations as an adjuvant therapy in the management of type 2~     diabetes.~   "
99648|NCT01752790|"~     Crohn's disease (CD) is an incurable debilitating disorder affecting an increasing number of~     children. The etiology remains elusive, but a genetically determined aberrant immune~     response against microbiota appears to be responsible. TNFα plays a pivotal role in the~     cytokine cascade of the inflammatory process and mediates multiple processes central to the~     pathogenesis of CD. The natural history of pediatric CD is characterized by recurrent~     flare-ups that severely impair patients growth, pubertal development and nutritional status.~     Epidemiological observations have shown that the course of CD, despite conventional~     treatment, inevitably progresses to the development of severe complications and surgery.~     Infliximab is the most widely used biological agent in moderate-to-severe pediatric CD. At~     present biologics are used after the failure of conventional drugs (step-up approach) and~     represent the peak of the CD therapeutic pyramid. The early use of biologics (top-down~     approach) has been demonstrated to be effective in adults with CD. The project aims at~     evaluating if a top-down approach may achieve mucosal healing before irreversible tissue~     damage present in late CD and thus alter the natural course of the disease, compared to the~     conventional approach. The study can also add information about the safety of infliximab~     used as first-line therapy and may add data on the benefit and costs of a reversal of the~     traditional therapeutic pyramid in pediatric CD, guiding the clinician in deciding in whom,~     when and how to introduce early aggressive treatment in daily practice.~   "
99649|NCT01752777|"~     Prevention strategies that aim to test and treat people for HIV infection are undermined by~     HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study~     will test a theory-based behavioral intervention to reduce HIV infectiousness by~     simultaneously improving HIV treatment adherence and reducing sexually transmitted~     co-infections in people living with HIV-AIDS who use alcohol and other drugs. The~     intervention is delivered in a single office-based counseling session followed by 4 cell~     phone delivered counseling sessions in a model that will be ready for immediate~     dissemination to case management and clinical services for people living with HIV/AIDS in~     resource constrained settings.~   "
99652|NCT01752738|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms~     governing their intestinal uptake and metabolism, however, are currently unknown. The~     investigators aim to explore these transport characteristics in depth. Therefore, colonic~     biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to~     available data of healthy controls. Insights in the mechanisms controlling intestinal~     transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it~     might lead to novel therapeutic targets in the treatment of chronic kidney disease.~   "
99653|NCT01752725|"~     The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified~     thermofu-sion and dissection instrument BiCision® in comparison with the long established~     Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy~     (LASH).~   "
99654|NCT01752712|"~     A significant proportion of people with schizophrenia are characterized by impaired ability~     to socially engage with others, which may reflect social aversion secondary to defeatist~     beliefs; decreased motivation for social interactions; and/or impairment in the normal~     reinforcement value of social interactions. These impairments in social function have been~     shown to be associated with social skill deficits; and decreased ability to identify and~     remember emotional facial expressions and empathize with the emotional status of others.~     Unfortunately, pharmacological interventions have limited benefits for impaired social~     function, whereas psychosocial interventions provide only partial benefit for this critical~     aspect of the illness. The development of an effective intervention for functional outcomes~     remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST)~     uses corrective feedback and reinforcement provided by successful interactions to challenge~     and reduce defeatist performance beliefs that contribute to low drive and interfere with~     social functioning. CBSST has been shown to have modest effects on social function in people~     with schizophrenia. Oxytocin plays a critical role in the regulation of normal social~     affiliative behavior; it is hypothesized to enhance social affiliation through the reduction~     of anxiety or social risk aversion; the enhancement of motivation for prosocial approach~     behavior; and/or increased modulation of the salience and processing of social cues. People~     with schizophrenia have decreased oxytocin levels, which are associated with an impaired~     ability to identify facial emotions and decreased prosocial behaviors. The study will be~     comprised of three phases: 1) 2-week Evaluation Phase; 2) 24-week Double-blind Treatment~     Phase; and 3) 3-month Follow-up Phase.~   "
99655|NCT01752699|"~     Neuropathic pain is a common condition and affecting 40 to 70% of the general population.~     Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment.~     Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose~     methadone in post-herpetic neuralgia patients who remained refractory after first and second~     line treatment for post-herpetic neuralgia (PHN) and had indication for the association of~     an opioid agent to their current drug regimen.~   "
99656|NCT01752686|"~     This study is designed to investigate the efficacy of carboplatin, as a post-operative~     adjuvant chemotherapy for triple negative breast cancer patients who have pathologic~     residual cancer after the preoperative chemotherapy.~   "
99657|NCT01752673|"~     Medical reasoning is a form of inquiry that examines the thought processes involved in~     making medical decisions. When physicians are faced with patients' symptoms or signs, their~     thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper~     and more analytic process to reach a diagnosis. The second pathway is less prone to biases~     and errors. This study explores whether the use of an interactive visual display of~     probabilities of pulmonary embolism generated from positive or negative test results will~     increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.~   "
99658|NCT01752660|"~     In the last decade physical exercise has become an accepted and integrated part of~     rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated~     whether the most severely disabled patients can tolerate and benefit from exercise therapy.~     The purpose of this study is therefore to evaluate the feasibility of endurance training in~     severely disabled patients with MS.~   "
99659|NCT01752647|"~     This prospective cohort trial was planned to assess the feasibility of establishing a lung~     cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic~     patients with at least a 30 pack-year history of cigarette smoking.~   "
99660|NCT01752634|"~     This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the~     registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self~     administration in subjects with active PsA despite current or previous NSAID, DMARD and/or~     anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be~     collected during the post Week 52 period of the study.~   "
99661|NCT01752621|"~     Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.~   "
99662|NCT01752608|"~     The primary objective of this study is to evaluate the safety and efficacy of an electronic~     cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting~     of a mood monitoring handheld computer application in the treatment of patients with mild to~     moderate major depressive disorder.~   "
99672|NCT01752478|"~     The purpose of this study to is to determine the incidence of post-operative ptosis in~     patients undergoing vitreoretinal surgery. An additional purpose is to identify~     pre-operative and intra-operative factors which correlate to the development of~     post-operative ptosis in vitreoretinal surgery cases.~   "
99682|NCT01752348|"~     The investigators hypothesize that the investigators can detect protein-sparing effects of~     administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an~     acute inflammatory disease. The investigators use the infusion of endotoxin, US standard~     reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate~     the effect on protein metabolism using different tracers and the investigators can measure~     the various intracellular signaling pathways of selected muscle and adipose tissue.~   "
99663|NCT01752595|"~     Auditory motor-coupling has been shown to induce neural-entrainment that can synchronize~     walking-pace with sonic tempo. The extent to which acoustical-motor entrainment can induce~     longer-term changes to physical activity behaviours remains unclear.~      Cardiac rehabilitation is essential and is associated with irrefutable mortality benefits~     for patients following an acute cardiac event. Randomized clinical trials have demonstrated~     a 25-50% improvement in survival as compared to controls; however, as many as 50% of~     patients will dropout of such programs prior to completion, which undermines these morbidity~     and mortality benefits (37; 54). Research exploring ways to improve compliance to such~     programs has suggested that the incorporation of music and other such holistic,~     patient-centered interventions into a rehabilitation/exercise program is associated with~     improved motivation, endurance and satisfaction amongst cardiac rehabilitation participants.~     The MAINTAIN study has been designed to conduct a feasibility evaluation on the effects of a~     preference-based music intervention on adherence to the cardiac rehabilitation program at~     Toronto Rehabilitation Institute. The primary objective of the trial is to evaluate the~     feasibility of the implementation of such a protocol within the context of the program.~      This is a two-arm, block 2:1 randomized trial. 35 patients participating in cardiac~     rehabilitation at Toronto Rehabilitation: Cardiac Rehabilitation and Secondary Prevention~     Program will be recruited and participants will be randomized into: 1) control (standard,~     usual care); and, 2) music intervention. The randomization process employed will be a~     blocked 2:1 strategy, whereby subjects are randomized to the music treatment arms 2:1. All~     those patients randomized into arm 2 will be equally randomized into either (2)~     preference-based music intervention, (3) preference-based music enhanced with RAS. The~     primary outcome measure will be weekly physical activity over a 3 month duration as measured~     using tri-axial accelerometers. We will also analyze the impact of a preference-based music~     intervention based on audio playlist utilization, self-reported sitting times~     ,exercise-times, on-site attendance to the cardiac rehabilitation program (attendance), peak~     oxygen uptake (VO2) (stress-test), and self-efficacy levels (self-efficacy questionnaires).~     These measures will be collected and analyzed throughout the course of the intervention (3~     months).~   "
99664|NCT01752582|"~     The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in~     terms of the extent of neointima formation at 3 months after implantation using OCT.~      This is a prospective, single center, randomized, open-label, non-inferiority study, which~     will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned~     undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority~     was met, superiority test will be planned.~   "
99665|NCT01752569|"~     Cancer is a leading cause of death in individuals living with human immunodeficiency virus~     (HIV), and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS is caused~     when individuals become infected with both HIV and another virus, Human herpesvirus-8~     (HHV-8). Laboratory studies have shown that HHV-8 can stimulate biological pathways within~     KS lesions which promotes their growth. Selumetinib targets these pathways and may therefore~     be a useful new therapy for KS. Phase I of this trial aims to identify the best dose for the~     use of selumetinib and investigate the effects of selumetinib treatment on the anti-viral~     treatment HIV patients receive to control HIV infection. Phase II of this trial will~     investigate how well selumetinib works as a treatment for KS at the best dose determined in~     phase I.~   "
99666|NCT01752556|"~     Primary objectives:~      The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against~     polysomnography (PSG) using the Epworth scale;~      Secondary Objective:~        1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth~          Scale and EuroQol 5D.~        2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2)~          adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry~          determinations. Design: prospective, randomized, controlled, open, parallel of~          non-inferiority. 440 patients will be randomized to diagnose and follow treatment based~          on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical~          analysis: We will compare the change in the Epworth scale between both arms of~          treatment through analysis of covariance. The premise of non-inferiority is -2 at the~          lower limit of 95% IC. Secondary variables will be analyzed using differences in~          independent means (or non-parametric equivalent) or Chi2 for dichotomous variables.~          Cost-effectiveness: costs generated by one and another method will be evaluated against~          the effectiveness of the primary variable using Bayesian techniques~   "
99667|NCT01752543|"~     The purpose of the present study is to evaluate the effects of a blockade of the vasopressin~     system and central hemodynamic system in heart failure (HF) patients during physical~     exercise. The significance of the vasopressin system during physical exercise is unclear. If~     vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to~     intervene against activation of the V1A-receptor might be expected to improve HF symptoms~     and possibly outcome.~      The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz~     catheter. Echocardiography will be performed at rest and during submaximal working capacity~     before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo.~     Cardiac output will be measured by thermodilution. The exercise test will be performed at 50~     % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The~     exercise test will be performed on a supine multistage bicycle.~   "
99668|NCT01752530|"~     The purpose of this study is to determine the effect of computer program C8 on specific~     cognitive functions, symptoms and functional outcome compared to treatment as usual in~     children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training.~     In addition, it will be investigated, whether younger children benefit more from training~     than older children.~   "
99669|NCT01752517|"~     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and~     etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC~     still relapse and 2-year survival is less than 10%. There is no standard treatment~     recommendation for this group of patients who failed to second-line therapy and had good~     performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer,~     i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC~     patients. Recently, a retrospective study showed the overall response rate was 30%, the~     median progression free survival (PFS) was 6.5 months, and the median overall survival was~     10.4 months in advanced combined SCLC patients treated with first-line regimen of~     vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration~     and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used~     as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this~     clinical trial is designed to prospectively investigate the efficacy and safety of NI~     regimen in refractory or recurrent ED-SCLC patients in our center.~   "
99670|NCT01752504|"~     The proposed study seeks to continue the implementation of Connect to Protect® (C2P), a~     community mobilization intervention, which entails developing coalitions to plan for and~     bring about structural changes for purposes of reducing HIV incidence and prevalence among~     youth in targeted communities at five ATN sites.~   "
99673|NCT01752465|"~     Antipsychotic medications frequently cause metabolic side-effects, such as abdominal~     obesity, high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all~     of which can lead to what is known as the Metabolic Syndrome and serious long-term~     cardiovascular health problems. Therefore, it is important that metabolic issues be~     addressed as part of a holistic approach to the mental health treatment of these patients.~      As with the general population, improving metabolic health involves lifestyle changes -~     i.e., addressing daily habits regarding eating, physical exercise, stress and sleep~     management, and lifestyle habits such as smoking. However, there is growing recognition in~     the medical field that education is not enough for people to create meaningful and sustained~     lifestyle change. The emerging field of Integrative Health Coaching addresses this issue and~     provides a clinical framework for helping people successfully develop and achieve~     personalized lifestyle goals. The investigators have therefore decided to investigate~     whether health coaching techniques may have benefit in addressing metabolic health issues in~     people with psychosis disorders. The intent is to complement usual psychiatric and medical~     care, and also promote patient engagement in managing one's overall health.~      This study will investigate whether Integrative Health Coaching is a useful clinical tool to~     facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with~     psychosis disorders.~   "
99674|NCT01752452|"~     Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient~     treated with external fixation.~   "
99675|NCT01752439|"~     The purpose of the study is to evaluate the efficacy of the transcranial direct current~     stimulation of the primary motor cortex (M1) in patients affected by refractory chronic~     migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and~     medication-overuse headache (coded as 8.1) with migraine as primary headache.~   "
99676|NCT01752426|"~     The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect~     the life cycle of blood-cancer cells. Cancer cells will be labeled with heavy water to~     learn about their birth rates and death rates.~      Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells~     that help cells live and grow. The study drug is designed to inhibit or block the activity~     of a type of kinase that helps blood-cancer cells live and grow. By blocking the activity of~     this specific kinase, it is possible that the study drug may kill the cancer cells or stop~     them from growing.~      Heavy water (2H2O) is a special type of water that is designed to help researchers learn how~     quickly cancer cells in the body reproduce.~   "
99677|NCT01752413|"~     The purpose of this study is to determine (1) the role of ferritin testing to screen for~     iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron~     replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of~     blood centers to routinely distribute oral iron replacement therapy to donors.~   "
99678|NCT01752400|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied and that research doctors are trying~     to find out more about it-such as the safest dose to use, the side effects it may cause and~     if the drug is effective for treating your type of cancer. It also means that the FDA has~     not yet approved the drug for your type of cancer or for any use outside of research~     studies.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the ALK gene. This mutated gene helps cancer cells grow. There is a drug (crizotinib)~     that has been approved by the FDA for the treatment of people with NSCLC who have mutations~     in the ALK gene. Most people respond to crizotinib initially. Over time, however, patients~     may stop responding (become resistant) to crizotinib because of additional changes in the~     ALK gene that makes crizotinib ineffective.~      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This~     drug has been used in other research studies. Information from those other research studies~     suggests that AUY922 may be effective in killing cancer cells that have become resistant to~     drugs like crizotinib. Only participants with changes in the ALK gene will be allowed to~     participate in this study.~      The purpose of this study is to test the safety of AUY922 and determine how well AUY922~     treats participants with advanced, ALK-positive NSCLC.~   "
99679|NCT01752387|"~     The purpose of this study is to compare the surgical treatment for sportsman's hernia in our~     department to the current literature. Our hypothesis is that combined solution for the two~     major problems that cause pain in this syndrome - repair the weakness in the posterior wall~     of the inguinal canal with tension free technique (mesh repair) and reducing the muscle~     strain on the abdominal wall by cutting, partially, the tendon of the external oblique~     muscle, will shorten the time to return to full physical activity in soccer players.~   "
99680|NCT01752374|"~     We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3~     antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea~     and vomiting after laparoscpic abdominal surgery.~      This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in~     the prevention of PONV for laparoscopic surgery in patients receiving PCA IV.~   "
99681|NCT01752361|"~     The purpose of this study is to describe gastrointestinal (GI) motility in patients~     suffering from severe Ulcerative Colitis (UC) and to compare these results with similar~     results from a study on healthy subjects.~      Both studies are done with the use of Motilis 3D-Transit system which consists of a small~     electronic capsule ingested and detected by a receiver carried by the patient. Position and~     orientation of the capsule are interpreted by dedicated computer software and transit times,~     progression velocity and contraction frequencies can be revealed.~      The study is mainly descriptive and is designed to test and evaluate the usefulness of the~     Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe~     inflammation.~      Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a~     whole during severe illness.~      We expect to include 20 patients suffering from severe UC admitted to Hospital with the~     purpose of getting medical treatment. We do not expect any drop out, but in case of drop out~     a new patient will be included.~   "
99725|NCT01751789|"~     The purpose of this study is to determine whether, for individuals in inpatient opioid~     detoxification, linking to outpatient Suboxone treatment increases treatment adherence and~     reduces relapse to illicit opioid use.~   "
99683|NCT01752335|"~     The purpose of this study is to determine whether tocilizumab changes the cardiovascular~     risk factors on patients with arthritis rheumatoid.~      Study hypothesis: the IL-6 contributes to increase the cardiovascular risk factors of~     patients with rheumatoid arthritis because it produces systemic effects as increasing weight~     and atherogenic body fat, changing energy homeostasis and inducing the adipokines production~     and the insulin resistence.~   "
99684|NCT01752322|"~     The purpose of this trial is to investigate the efficacy and safety of lidocaine 5%~     medicated plaster in localized chronic post-operative neuropathic pain in comparison to~     placebo plaster.~   "
99685|NCT01752309|"~     Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by~     synovial membrane inflammation, possibly leading to destruction of joints. To start early~     with a combination therapy results in a better outcome for patients. Using ultrasonography~     it is possible to detect clinically and radiographically absent synovitis and erosions.~     However, it is unclear whether or not these findings have predictive value in these patients~     regarding disease activity or radiographical progression.~   "
99686|NCT01752296|"~     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal~     recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage~     diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes~     of and finding a treatment for the physical aspects of the various diseases. Less attention~     has been paid to the psychological or emotional toll of these diseases, whether they are~     direct symptoms of the diseases themselves or reactions to living with a chronic progressive~     disease.~      It is well established in the health psychology literature, however, that the interaction~     between our physical health and our psychological health is bidirectional; that is, just as~     our physical health affects us emotionally (e.g. chronic pain can contribute to depression),~     so can our psychological health affect us physically (e.g. anxiety can contribute to~     feelings of chest pain). It is thus critically important to pay attention to the emotional~     and psychological symptoms associated with all lysosomal storage diseases, including~     Morquio, and expand our treatment standard of care to include mental health treatment, if~     necessary.~      The first step in understanding and treating psychological conditions in Morquio disease is~     determining the natural occurrence of psychological symptoms in this population in~     comparison with non-medical populations. As little has been done in this regard, a pilot~     study documenting the occurrence rate of psychological issues and overall quality of life in~     patients with Morquio is the first item in order and will be the focus of this study.~      Approximately 20 patients with Morquio disease will be invited to participate, recruited~     through Emory's Lysosomal Storage Disease Center, as well as through attendance at Morquio~     support groups and relevant regional, national and/or international meetings. Once~     consented, patients will be asked to complete three different self-report questionnaires,~     including the Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report~     (ASR) or Older Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health~     Questionnaire (SF-36), and the Brief Pain Inventory (BPI). Group aggregate data only will be~     reported; individual questionnaire content and results will be held confidential, except as~     in accordance with Georgia law relating to reporting of child or elder abuse, suicidal~     and/or homicidal intent. Completion of these questionnaires will complete subjects'~     participation in this pilot study.~   "
99687|NCT01752283|"~     The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy~     under hypnosis in comparison to general anesthesia~   "
99688|NCT01752270|"~     Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to~     affect more than 5% of the population and is associated with chronically elevated serum~     androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative~     impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive~     disease during pregnancy,and preterm birth,which is partially related with the~     hyperandrogenic environment.Diane-35 has been proved to be the most effective~     anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive~     effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro~     fertilization/Intracytoplasmic sperm injection.~   "
99689|NCT01752257|"~     The purpose of this pilot study is to determine the prevalence of markers of chronic and~     cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma~     tumor microenvironment. The study is based around four cornerstone features of the~     pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen~     species), HIF-1 and VEGF, which the investigators term the HRHV axis. Patients with~     in-transit melanoma (AJCC Stage IIIB or IIIC) (1) will be administered the hypoxia marker~     drug, EF5, 24 hr prior to isolated limb infusion (ILI) or hyperthermic isolated limb~     perfusion (HILP). Tumor biopsies will be performed just prior to ILI or HILP, at the 30~     minute time point during ILI (or 60 minute time point during HILP), AND 24 hours after ILI~     or HILP. Tissues obtained will be snap frozen and subsequently analyzed for EF5 binding.~     Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that~     depict the HRHV axis will also be examined. The association of the markers with the presence~     of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study~     will be used to establish the prevalence of markers of the HRHV axis in melanoma. This~     information will be crucial for future human trials in which the HRHV axis is~     therapeutically targeted.~   "
99690|NCT01752244|"~     Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin~     resistance. Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin~     D. Although analogues of vitamin D3 have extensively been used in the treatment of various~     chronic inflammatory diseases, to our knowledge, no such research is conducted in regards~     with obesity. The aim of this double blind clinical trial study is to investigate whether~     alphacalcidol treatment in obese subjects can affect the insulin resistance. Moreover, we~     will evaluate the pathways of Vitamin D receptor (VDR), Peroxisome proliferator-activated~     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α~     (PGC1α) gene expressions which may lead to insulin resistance following treatment with~     either alphacalcidol or placebo.~   "
99691|NCT01752231|"~     This pilot clinical trial studies dynamic contrast enhanced (DCE)-magnetic resonance imaging~     (MRI) in diagnosing cancer. New diagnostic procedures, such as DCE-MRI may help find and~     diagnose cancer~   "
99692|NCT01752218|"~     The purpose of this open, prospective study is to address the effectiveness and precision of~     the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after~     femtolaser-assisted cataract surgery.~   "
99693|NCT01752205|"~     The purpose of this study is to test the safety and effectiveness of erlotinib and~     chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous~     cancer .~   "
99726|NCT01751776|"~     To evaluate the safety and tolerability of multiple doses of BI 655064 administered~     subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To~     explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI~     655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess~     clinical effect of BI 655064 in RA patients with prior inadequate response to methotrexate~     (MTX) after 12 weeks of treatment~   "
99694|NCT01752192|"~     The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and~     technologies so that all types of heart disease patients, regardless of degree of severity,~     can be offered individual, customized and coordinated tele-rehabilitation across sectors.~     The project is innovative, breaking new ground in relation to existing national and~     international research projects in the area. The Teledi@log consortium sees its major task~     as developing and testing scenarios which can lead to a more coherent rehabilitation for~     heart patients in areas such as patient training, organization across the boundaries of the~     health system and using tele-rehabilitation technology. The Teledi@log consortium seeks to~     develop new tele-rehabilitation concepts which bring the patient closer to the health system~     and thereby promote the heart patient's rehabilitation, giving the patient and their~     families a more active role via new tele-rehabilitation technologies.The hypothesis of the~     study is that heart patients participating in a telerehabilitation program will have a~     higher quality of life compared to heart patients following traditional rehabilitation~     activities.~   "
99695|NCT01752179|"~     Kinesio taping is a novel method which recently has emerged as a viable option to treat of~     various musculoskeletal and neuromuscular deficits. The application of tape to injured soft~     tissues and joints provides support and protection for these structures. Many different~     techniques are used for injury prevention, treatment, rehabilitation, proprioception and~     sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A~     trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are~     also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot,~     associated with a taut band of a skeletal muscle that is painful on compression or stretch,~     and that can give rise to a typical referred pain pattern as well as autonomic phenomena.~     The use of tape along muscle to unload affected soft tissue seems to be effective in the~     treatment of trigger points by inhibiting overactive muscle, changing the orientation of~     fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of~     Kinesio taping application on trigger point of piriformis muscle.~   "
99696|NCT01752166|"~     The purpose of this study is to validate clinical performance (i.e. estimated sensitivity~     and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture~     results and/or known Candida positive status of prospectively collected and contrived (i.e.~     Candida-spiked) clinical specimens.~   "
99697|NCT01752153|"~     A wide spectrum of immune abnormalities has been described by numerous studies involving~     β-thalassemic patients with multiple transfusions. The abnormalities observed are both~     quantitative and functional, and concern several components of the immune response.~     Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert~     multiple biological effects, including antioxidant and free radical scavenging abilities.~     Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn),~     have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as~     hepatoprotective agents. Silymarin is already being used clinically for treatment of liver~     diseases.It is considered safe and well-tolerated, with reported adverse events similar to~     placebo. Several studies have also reported immunomodulatory actions of silymarin. It~     increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10~     secretions by stimulated lymphocytes in a dose-dependent manner. It has been shown that in~     vitro treatment of peripheral blood mononuclear cells with silymarin causes restoration of~     the thiol status and increases in T cell proliferation and activation. Because reactive~     oxygen species and iron overload play important roles in the pathophysiology of thalassemia,~     silymarin may be an effective therapy due to its antioxidant, immunomodulatory,~     cytoprotective and iron chelating activities. The present study designed to investigate the~     therapeutic activity of orally administered silymarin for treatment of β-thalassemia major,~     a well-known and prevalent disease in Iran, which is associated with oxidative stress, iron~     overload and immune abnormalities.~   "
99698|NCT01752140|"~     In this study, the investigators aim to determine if the Vienna nomogram increases the~     detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study~     comparing the Vienna nomogram with a 10-core biopsy protocol.~   "
99699|NCT01752127|"~     The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott~     Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although~     these are thought to be superior in effect and stability compared to ZES and EES of previous~     generation, there are few clinical data regarding the high risk groups of diabetes patients~     or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer~     study (23% diabetes), the investigators could not know the outcome in high risk patients~     such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate~     the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small~     vessels lesion patients.~   "
99700|NCT01752114|"~     This study is intended to determine the positive predictive value (PPV) and negative~     predictive value (NPV) of the multiprotein classifier based on the observed study prevalence~     of Non-Small Cell Lung Cancer (NSCLC) in the study participants.~   "
99701|NCT01752101|"~     The primary objective is to identify a panel of plasma and/or serum proteins that~     differentiates the absence or presence of lung malignancy in samples obtained from subjects~     enrolled in this IRB/EC approved study with pulmonary nodules.~   "
99702|NCT01752088|"~     This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of~     arthroscopic repair of subscapularis tears~   "
99703|NCT01752075|"~     The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients~     treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in~     a real-world setting (versus a clinical trial).~   "
99704|NCT01752062|"~     The objective of this study is to acquire more information about what we are doing during~     pregnancy in CML patients, in order to possibly establish in the future a consensus on the~     management of patients receiving TKIs who wants to father a child or become/are pregnant.~   "
99780|NCT01751061|"~     Deciding about prolonged life support for critically ill patients can be very difficult.~     Therefore, the investigators are doing a study to see if an internet-based decision aid can~     improve the quality of decision making for substitute decision makers of patients who are in~     the intensive care unit (ICU).~   "
110978|NCT01603628|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in~     pediatric patients with lower limb spasticity.~   "
99705|NCT01752049|"~     Hereditary hemorrhagic telangiectasia (HHT) is a hereditary vascular condition characterized~     by the development of abnormal connections between arteries and veins throughout the body,~     called vascular malformations. These abnormal blood vessels are referred to as arteriovenous~     malformations (AVM) if they are large and telangiectasias if they are small. Telangiectasias~     develop due to irregular growth of blood vessels.~      Anti-angiogenic therapy, such as the drug Apo-Timop, curbs the growth of new blood vessels.~     Apo-Timop is included in a class of medications called beta-blockers. Anti-angiogenic~     therapies exert their beneficial effects in a number of ways: by disabling the agents that~     activate and promote cell growth, or by directly blocking the growing blood vessel cells.~      The investigators think that anti-angiogenic therapy may lead to the shrinking of~     telangiectasia in people with HHT. The investigators hope that this study will provide us~     with proof of this concept and might lead to the development and study of anti-angiogenic~     therapies to help improve the lives of individuals with vascular malformations.~   "
99706|NCT01752036|"~     Although it is being increasingly used off protocol, there is minimal data regarding the~     efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of~     metastatic lesions to the spine. The primary objective of this study is to evaluate~     radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared~     to the expected rate following conventional radiation therapy.~   "
99707|NCT01752023|"~     Response rates.~      Changes in tumor blood flow.~   "
99708|NCT01752010|"~     The primary objective of this preliminary study is to compare the Tennant BioModulator with~     Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for~     the management of chronic pain among injured service members. The secondary objective is to~     investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder~     (PTSD) symptoms, or depression.~   "
99709|NCT01751997|"~     This study will compare the clinical outcomes of transplants from~     family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated~     donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings~        1. Primary objectives: Overall survival of FMT may be similar to that of MUT~        2. Secondary objectives:~           i. Comparison of disease-free survival, relapse, non-relapse mortality, immune~          reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host~          disease between FMT and MUT.~           ii. Investigation of possible biomarkers related with above events after~          transplantation~   "
99710|NCT01751984|"~     This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in~     subjects with hypercholesterolemia and a history of statin intolerance.~   "
99711|NCT01751971|"~     This study seeks to employ advanced methods to estimate the individual factors contributing~     to sleep apnea from standard recordings made during routine clinical sleep studies. This~     study focuses on breathing control or loop gain as one of the factors contributing to~     sleep apnea. Increased levels of oxygen in the air is known to make breathing more stable by~     lowering loop gain. Here, our goal is to use a new method capable of detecting a reduction~     in loop gain with oxygen. The investigators also aim to test whether a high loop gain~     measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen~     therapy.~   "
99712|NCT01751958|"~     Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring~     during lumbar ESI~   "
99713|NCT01751945|"~     The purpose of this study is to determine whether an integrated EmONC package (community~     mobilization, training of community-based health care providers and a maternal and neonatal~     health pack) reduce perinatal and neonatal mortality.~   "
99714|NCT01751932|"~     The purpose of this study is to assess the accuracy of two continuous glucose monitoring~     devices (the Dexcom G4 Platinum and Medtronic Enlite systems) in patients with type 1~     diabetes mellitus.~   "
99715|NCT01751919|"~     1. Investigational Product~             1. Imatinib mesylate tablet 400 mg~             2. Glivec film-coated tablet 100 mg (Comparator)~        2. Expected target disease~             1. chronic myeloid leukemia~             2. Gastrointestinal stromal tumors~        3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover~          study~             1. 36 healthy subjects, 2 groups (18 subjects/group)~             2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))~             3. wash-out period : 14 days~        4. Evaluation on pharmacokinetics(PKs) and safety~             1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2~             2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test~        5. Statistical method~             1. Demography Characteristics~             2. Pharmacokinetic parameters~             3. Safety data~   "
99716|NCT01751906|"~     The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the~     pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular~     Scaffold (BVS).~      The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics)~     sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial~     designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB~     III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials~     will evaluate the safety and effectiveness of Absorb BVS.~   "
99717|NCT01751893|"~     The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly~     occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants~     special attention because it is the most common dose-limiting toxicity. this study is~     designed to test the effectiveness of a henna treatment protocol in the management of~     capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar~     erythrodysesthesia.~   "
99727|NCT01751763|"~     Radical hepatic resection represents one of the treatment options offering a prospect for~     cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of~     these radical resection actually turned out to be non-radical in nature. For these~     patients who actually received non-radical resection, their by year survival rates were much~     lower than those who received radical hepatectomy. In this prospective, non-interventional,~     multi-center study, we are planning to observe the patient characteristics of Hepatocellular~     carcinoma (HCC) patients who have residual disease after resection with curative intent, as~     well as treatment pattern, safety and effectiveness of sorafenib for these patients.~   "
110979|NCT01603615|"~     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the~     treatment of pediatric upper limb spasticity.~   "
99718|NCT01751880|"~     Gastric cancer is a major health issue and one of the most common malignance in Korea. With~     the popularization of cancer screenings and increasing the average lifespan, the number of~     gastric cancer patients is increased. In the past, most of the research were concerned with~     survival and recovery after cancer surgery. However, as the medical technology had been~     developed and recovery rate and survival rate of cancer patients had risen, the patients~     wanted to return to a daily life and desire for participation for leisure. In other words,~     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as~     like prior to cancer surgery.~      There are many reports on the effect of the exercise program after cancer surgery. In~     addition, exercise program was associated with improving the QOL and functional recovery,~     decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.~      However, the subject patients of previous studies were Western people. Therefore, The~     results were not disclosed whether the exercise program suited to the body characteristics~     of Korean people. Furthermore there was no exercise program studies for the gastric cancer~     patients.~      Medical service for cancer patients care should include not only diagnosis, treatment as~     like surgery but efforts on enhancing the quality of life. In other words, post-management~     education and management program as like exercise program are necessary for the cancer~     patients after surgery. So, the research about how to practice the exercise program and how~     to evaluate the effect on the recovery is needed.~   "
99719|NCT01751867|"~     The purpose of this study is to evaluate the effectiveness and safety of decitabine in the~     treatment of myelodysplastic syndrome (name of a group of conditions that occur when the~     blood-forming cells in the bone marrow are damaged) in Chinese patients.~   "
99720|NCT01751854|"~     The information derived from this study will be critical to establishing appropriate~     rehabilitative interventions post-stroke. In particular, traditional use of pharmacological~     agents to alter motor function post-stroke is directed primarily at reducing the positive~     signs following upper motor neuron lesion, in particular spasticity, or enhanced,~     velocity-dependent stretch reflex responses to imposed stretch. While pharmacological~     management of spasticity certainly suppresses clinical and quantitative measures of~     hypertonia, there is little improvement in functional performance. In contrast, preliminary~     data on the administration of 5HT agents following neurological injury indicates an increase~     in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic~     motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to~     maximize function following stroke despite potential, short-term increases in spastic motor~     activity may improve therapeutic intervention strategies. The general objective of this~     study is therefore to:~        1. quantify the effects of short-term SSRI administration on voluntary and spastic motor~          behaviors in individuals with chronic spastic hemiparesis,~        2. identify the changes in impairments and functional recovery of walking ability during~          BWSTT with the presence or absence of SSRIs.~   "
99721|NCT01751841|"~     Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally~     invasive spine surgery~   "
99722|NCT01751828|"~     The long-term goal is to determine if decreased blood flow to the brain (cerebral~     hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD).~     Studies in younger adult report that successful antidepressant treatment is associated with~     increases in cerebral blood flow, with no change in blood flow being observed in~     nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to~     antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD~     is characterized by cerebral hypoperfusion and it does have predictive power to identify~     individuals who will poorly respond to conventional antidepressants, this would support the~     study of interventions that improve cerebral perfusion and may improve antidepressant~     outcomes.~      As an initial step in this research, this pilot study will utilize MRI to examine if resting~     blood flow deficits predict and persist with antidepressant nonremission in an elderly~     population. The rationale for this proposal is that it will guide the design and power~     requirements of a larger, definitive trial examining the relationship between cerebral~     perfusion and depression outcomes. Importantly, support for this mechanism being linked to~     LLD would also support studies examining the antidepressant efficacy of drugs that may~     improve cerebral perfusion.~      The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting,~     scanning, and treating depressed elders; and b) to acquire preliminary data for competitive~     grant submissions.~      SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals~     who do and do not remit to a 8-week course of sertraline.~   "
99723|NCT01751815|"~     Background:~      Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric~     Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used~     successfully to treat pain of various origins, but few good-quality studies have evaluated~     its role in treating pain and anxiety during colonoscopy.~      Objective:~      To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the~     consumption of sedatives/analgesics during colonoscopy.~      Design:~      Prospective, randomized, placebo-controlled study.~      Subjects:~      One hundred and twenty eight consecutive patients undergoing first-time elective day-case~     colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.~      Interventions:~      Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before~     colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension,~     including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS~     group, a non-conductive plastic film will be placed between the acupoint and the electrode~     so that no current will be transmitted. Acu-TENS and placebo-TENS will be continued~     throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a~     patient-controlled syringe pump, will be used for sedation/analgesia in both groups.~      Outcome measures:~      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary~     outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation~     rate/time, and episodes of hypotension/desaturation.~   "
99724|NCT01751802|"~     The purpose of this research study is to gather scientific information about the~     effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of~     self-injurious behaviors when compared with the effectiveness and safety of placebo~     (inactive substance) in subjects with Lesch-Nyhan Disease.~   "
99728|NCT01751750|"~     The objectives of this study are the following: 1) to confirm that the administration of~     grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and~     urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined~     administration of grape juice, resveratrol, and grape seed polyphenol extract result in a~     similar plasma and urinary metabolic profile in adults with tendencies toward metabolic~     syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory~     effects of the combined administration of grape juice, resveratrol, and grape seed~     polyphenol extract.~   "
99729|NCT01751737|"~     This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for~     prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI~     guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.~   "
99730|NCT01751724|"~     Most premature infants require mechanical ventilation for prolonged periods of time and a~     significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a~     stimulant of the respiratory center and has been used for the treatment of Apnea of~     Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from~     mechanical ventilation by starting therapy shortly before extubation. Recently the use of~     Caffeine in ventilated infants has been initiated earlier because of the reported reduction~     in BPD. However there is paucity of data supporting this practice.~      Because protracted mechanical ventilation and supplemental oxygen increase the risk of~     developing BPD, a therapy that would facilitate the reduction of the respiratory support and~     shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of~     early Caffeine initiation and administration during the course of mechanical ventilation in~     preterm infants by means of a randomized placebo-controlled trial.~      Hypothesis:~      The primary hypothesis of this study is that early use of caffeine in mechanically~     ventilated preterm infants will reduce the time to first elective extubation and~     secondarily, that this will reduce the total duration of mechanical ventilation and oxygen~     supplementation, and reduce the incidence and severity of BPD.~      Objective:~      The objective of this trial is to evaluate the effects of early caffeine use during~     mechanical ventilation on the time to first elective extubation, total duration of~     mechanical ventilation and oxygen supplementation, and the incidence of BPD.~      Study Design:~      This will be a single-center prospective, randomized, double-blind, placebo controlled~     clinical trial.~      Population:~      Premature neonates born between 23 and 30 completed weeks of gestation, who require~     mechanical ventilation within the first 5 days of life will be enrolled. Infants with major~     congenital anomalies or small for gestational age will be excluded.~      Methods:~      Infants will be randomized within the first 5 days to receive a study drug consisting of~     either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline).~     Infants will continue to receive the study drug until the first elective extubation.~   "
99731|NCT01751698|"~     Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks~     support to construct an adaptive intervention that utilizes two efficacious interventions~     (JASP-EMT and CORE- DTT) that have shown promise for optimizing the number of unique~     socially communicative and spontaneously spoken words in minimally verbal children with ASD.~     The study utilizes a novel sequential multiple assignment-randomized trial to evaluate and~     construct an optimal adaptive intervention. A total of 192 minimally verbal school aged~     children with an Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across~     four sites, University of California Los Angeles, University of Rochester, Vanderbilt~     University and Weill Cornell Medical Center with methodological and statistical support from~     University of Michigan.~   "
99732|NCT01751685|"~     We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or~     older with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal~     muscle strengthening exercises compared to a usual care control group. The study will be~     conducted in five waves,with 10 participants in the exercise intervention and 10~     participants in the control group in each wave.~   "
99733|NCT01751672|"~     The purposes of this study are to: 1) implement a high fidelity Screening, Brief~     Intervention and Referral to Treatment (SBIRT) protocol with computerized screening~     technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized~     controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more~     specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3)~     conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of~     focus groups and structured interviews to assess implementation barriers and workforce~     attitudinal shifts; and 4) provide an excellent clinical research training environment for~     undergraduate and graduate students from Lincoln University.~   "
99734|NCT01751659|"~     This is a three phase study designed to examine clinician behaviors with regard to~     recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human~     Immunodeficiency Virus (HIV) prevention strategy, and to identify knowledge-related and~     attitudinal factors associated with these behaviors. Each phase consists of the following:~      Phase 1: Semi-structured face-to-face or telephone interviews of ATN-affiliated clinicians.~     Approximately 10 clinicians will be interviewed.~      Phase 2: Development of a new theory-based survey instrument and cognitive interview testing~     of this survey. Approximately five clinicians (of those who participated in Phase 1) will be~     interviewed.~      Phase 3: Administration of the newly developed survey to ATN-affiliated clinicians.~     Approximately 60 clinicians will be interviewed.~   "
99735|NCT01751646|"~     This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of~     adolescents and young adults with HIV infection in the ATN who are currently being treated~     with cART that includes TDF as one component of the regimen that includes at least three~     Food and Drug Administration (FDA)-approved ARVs for at least 180 days.~   "
99736|NCT01751633|"~     Thoracolumbar fractures are the most common spinal fractures with an average annual~     incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO~     type A3 (burst fractures). Although patients with burst fractures report a reduced quality~     of life and chronic pain, there is no clear evidence whether surgical or conservative~     treatment offer better functional and back-pain related outcomes. The indications for the~     selection of an ideal treatment for these fractures without neurological deficits remain~     controversial. The purpose of this study is to evaluate whether patients with thoracolumbar~     fractures without neurological deficit being surgically treated show faster recovery and~     better improvement of function than patients being conservatively treated.~   "
99737|NCT01751620|"~     The proposed study is a two-group randomized repeated measures design that will examine the~     efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting~     Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU~     sites across the United States. Youth will be randomized into one of two study arms; Project~     ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison~     condition. Both arms consist of two individual sessions followed by six group sessions and a~     final individual session which is expected to take approximately nine weeks after which~     youth will have four follow-up visits at the following time points:~        -  post intervention (immediately after the last session);~        -  3 months post the last session;~        -  6 months post the last session; and~        -  12 months post the last session. The trial will be repeated in up to three waves.~   "
99739|NCT01751594|"~     The proposed research study aims to conduct a culturally-based secondary prevention~     intervention targeted toward HIV-positive Black young men who have sex with men (B-YMSM) to~     explore (1) feasibility and acceptability (Trial 1 and Trial 2) and (2) evidence of~     potential efficacy (Trial 2). The primary outcomes will be health promotion behaviors (i.e.,~     treatment adherence, sexual risk reduction, reduction in substance use behaviors, and HIV~     status disclosure). Psychosocial factors (i.e. self-esteem, critical consciousness, and~     socio-political awareness) will be examined as secondary outcomes.~   "
99740|NCT01751581|"~     Each 4-day period will follow the same protocol. Basically, for the entire study, we will~     prepare all of the subject's food and will require him or her to eat all of the food that we~     give at the times we tell them to eat. The subject will arrive at the hospital on the~     evening of day 1, and become inpatients. On day 2, the subject will be permitted to leave~     the hospital campus under the supervision of the research staff. On day 3, they will be~     required to stay in a small room called a metabolic chamber for 24 hours. This room measures~     how many calories you burn in one day. On day 4, we will measure the subject's energy~     expenditure in response to a breakfast meal. They will be given breakfast and the number of~     calories that they burn after that meal will be measured over a 6-hour period. Then the~     subject will be discharged at the end of the test. The 2 study periods will differ only in~     bedtimes and wakeup times. During one period, the subject will go to bed at 1 am and wake up~     at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.~   "
99741|NCT01751568|"~     People who are infected with HIV and tuberculosis (TB) need to receive medications that~     treat both diseases safely and effectively. This study will enroll children infected with~     HIV and TB and evaluate the safety and tolerance of an antiretroviral (ARV) treatment~     regimen for HIV that contains raltegravir when administered with a TB treatment regimen that~     includes rifampicin. Study researchers will also determine the most effective dose of~     raltegravir for children when it is taken with rifampicin.~   "
99742|NCT01751555|"~     This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and~     safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human~     immunodeficiency virus-1 and hepatitis B virus coinfection.~   "
99743|NCT01751542|"~     Randomized clinical trial comparing standard residential substance abuse treatment to~     standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance~     use.~   "
99744|NCT01751529|"~     This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced~     ultrasound when used to evaluate renal lesions in two different populations; patients with~     known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom~     their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort~     2).~   "
99745|NCT01751516|"~     This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal~     cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before~     and after surgery.~   "
99746|NCT01751503|"~     Foot drop deformity is a life limiting condition characterized by loss of ankle dorsiflexion~     and eversion. Main condition leading to drop foot condition include irrecoverable muscle and~     nerve injuries, poliomyelitis, drug poisoning, strokes, cerebral palsy, Charcot - Marie -~     Tooth disease, meningomyelocele, club foot, Friedreich's ataxia and Leprosy (1-4).~      Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical~     restoration of functional dorsiflexion of a permanently paralyzed foot (1, 4-10). Two~     methods of rerouting the posterior tibialis tendon have been reported, one through the~     interosseous membrane i.e. Interosseous route (7, 10) and second subcutaneously around the~     medial side of tibia i.e. Extramembranous or circumtibial route (11-13). Both these~     techniques have been widely described in literature (4-16) and are being extensively used in~     surgical management of foot drop. The selection of technique depends on surgeon choice and~     patient factors.~      There is a clinical equipoise with regards to these two techniques of Tibialis posterior~     tendon transfer and through our study we aim to compare the clinical and functional outcomes~     of these two techniques. There are no studies in literature which compare the clinical and~     functional outcomes with regards to both these methods. Although there are many studies to~     demonstrate the functional and clinical effectiveness of the respective procedures, there is~     a paucity of clinical trials comparing these two surgical techniques with regards to~     clinical and functional outcomes. Furthermore there are no head to head clinical trials to~     compare the outcomes with regards to these two methods of Tibialis Posterior tendon transfer~     (Medline search dated 03/03/ 2012)~      we propose to compare the clinical and functional outcomes with regards to the two~     techniques i.e extra membranous and Interosseous technique of Tibialis Posterior tendon~     transfer performed in patients with foot drop as a result of nerve palsy.~      Through our prospective randomized trial we aim to answer the research question, whether one~     method has any superior outcome over the other?~   "
99747|NCT01751490|"~     We will conduct a randomised clinical trial with the primary aim of determining whether~     surgical intervention followed by physiotherapy rehabilitation improves pain and disability~     outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic~     shoulder instability associated with bony/capsulolabral damage. The results of this study~     will have direct and immediate impact on clinical decision making by establishing~     definitively if patients presenting with joint damage associated with atraumatic shoulder~     instability should be referred for surgery before commencing physiotherapy rehabilitation.~     The results of this study may also result in significant cost savings to the National Health~     Service if surgical intervention for atraumatic shoulder instability does not result in~     greater improvement than physiotherapy alone.~   "
99748|NCT01751477|"~     Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies~     in preterm neonates and a leading cause of death and morbidity.~      The pathogenesis of NEC remains largely unclear, but it is widely considered as a~     multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and~     intestinal ischemia have been proposed as major risk factors.~      Probiotics may prevent NEC by improving the maturity and function of the gut mucosal~     barrier, modulating the immune system, promoting colonization of the gut with beneficial~     organisms and preventing colonization by pathogens.~      A variety of clinical trials have evaluated the effect of different probiotic preparations~     on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a~     benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of~     practice.~      The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in~     reducing the incidence of NEC after implementation in clinical routine in preterm (< 34~     weeks gestational age) very low birth weight infants compared to a historical cohort.~   "
99749|NCT01751464|"~     This is a feasibility study of a WrapAround Case Management Program for Youth Injured by~     Violence. Youth (aged 10-24) who have been injured by violence and visit the emergency~     department will be offered a support worker who will provide WrapAround Case Management.~     This study is designed to assess the feasibility of recruitment, enrollment and follow-up.~   "
99750|NCT01751451|"~     In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug~     abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients~     with metastatic castration-resistant prostate cancer who have received prior docetaxel~     (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone~     to treat patients with metastatic castration-resistant prostate cancer who have not received~     prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly~     injection, is FDA approved for the treatment of patients with advanced prostate cancer. The~     purpose of this study is to evaluate abiraterone acetate and prednisone in combination with~     degarelix as a possible treatment for PSA recurrent prostate cancer as compared to~     abiraterone acetate alone and degarelix alone. This will be the first time these drugs will~     be used together.~   "
99751|NCT01751438|"~     The goal of this clinical research study is to learn if treatment with standard systemic~     therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery~     or radiation therapy is more effective at controlling prostate cancer than standard systemic~     therapy alone. The safety of this treatment combination will also be studied.~   "
99752|NCT01751425|"~     This is a 2 part study. The goal of the first part of this clinical research study is to~     find the highest tolerable dose of ruxolitinib that can be given with a TKI that you are~     already taking (such as gleevec, sprycel, or nilotinib) as part of your standard of care~     treatment. The goal of the second part of this study is to learn if this drug combination~     can help to control CML. Although you have a good response to therapy, the disease is still~     detectable at low levels (this is called minimal residual disease). Researchers believe~     that eliminating all detectable evidence of disease may decrease the chances that the~     leukemia will ever come back. The safety of the drug combination will also be studied in~     both parts.~      Ruxolitinib is designed to block a protein called Jak2 that may help keep some leukemia~     cells alive even with TKI therapy. Blocking this protein may cause the cells to die.~   "
99753|NCT01751412|"~     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical~     to do this type of research on a larger scale in the future. The pilot part of this study is~     to assess the possibility of using proton radiation to treat lymphomas. Proton radiation is~     used for many other types of malignancies, but its use for the treatment of lymphoma has~     been limited. The treatment is still being studied as research doctors are trying to find~     out more about its use in the treatment of different types of lymphoma. Proton beam~     radiation therapy is an FDA approved radiation delivery system.~      Patients are being asked to participate in this research study if they have lymphoma in the~     center of their chest, near their heart. Conventional radiation therapy with photons is used~     as standard treatment for many patients with lymphoma. In this research study investigators~     are looking at another type of radiation called proton radiation, which is known to spare~     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the~     area requiring radiation but delivers no dose beyond the region requiring treatment. This~     may reduce side effects that patients would normally experience with conventional radiation~     therapy or other means of delivering proton radiation therapy.~      In this research study, investigators are evaluating the effectiveness of using proton~     radiation delivered to reduce side effects associated with radiation treatment.~   "
99754|NCT01751399|"~     The primary purpose of this study is to help answer the following research questions:~        -  To evaluate how much of the study drug (LY2605541) is in the blood of participants with~          varying degrees of liver impairment compared to those with normal liver function~        -  To assess the safety of LY2605541 and any side effects that might be associated with it~   "
99755|NCT01751386|"~     Background:~      - Baclofen is a drug used to control muscle stiffness in people with neurological diseases.~     Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce~     anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if~     baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.~      Objectives:~      - To see if baclofen is safe and helpful for people who have alcoholism and high anxiety~     levels.~      Eligibility:~        -  Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and~          anxiety issues.~        -  Participants must not be taking anti-anxiety medication.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tests of alcohol dependency and anxiety levels will also be~          given.~        -  Participants will be divided into two groups. One group will take baclofen. The other~          group will have a placebo.~        -  About 1 week after the screening visit, participants will have a study visit. They will~          answer questions about their behavior and mood. They will then start to take either~          baclofen or a placebo. Participants will take the study drug three times a day, every~          day.~        -  After 1 week on the study drug, participants will have an overnight stay at the~          National Institutes of Health. They will have blood tests and answer questions about~          mood and behavior. They will also have tests that involve choosing to drink alcohol and~          answering more questions about cravings.~        -  Participants will stop taking their study drug over a 3-day period.~        -  A final follow-up visit will be required 1 week after the overnight study visit.~          Participants will receive information about other alcohol abuse treatment programs.~   "
99756|NCT01751373|"~     Within the first year after stroke, approximately 38% of stroke survivors experience an~     increased resistance to movement, also called spasticity. One type of treatment that is~     approved for stroke survivors in Canada that could reduce spasticity is the injection of~     Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is~     limited evidence to show that BTX administration leads to functional improvements. This may~     occur because the outcomes aren't sensitive enough to detect change, some people may have~     better responses to BTX, or because BTX hasn't been paired with the right exercises to~     improve function. The aims of this research are: i) to determine if there is a way of~     improving the markers that measure change in response to treatment; and ii) to identify the~     ideal type of exercise that should be paired with BTX to allow the drug to have it greatest~     effect.~      There are two primary research questions: a) What are the measures that will indicate~     whether a person with post-stroke spasticity will benefit from BTX therapy? It is~     hypothesized that EMG latency and amplitude, for those who best respond to BTX, will differ~     from those who demonstrate a weaker response to BTX; b)What is the ideal training approach~     for improving muscle function in stroke survivors receiving BTX injections? It is~     hypothesized that a training protocol that focuses on optimizing specific muscle activation~     patterns will demonstrate better outcomes than a training program designed to improve~     function.~   "
99757|NCT01751360|"~     To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.~   "
99805|NCT01750736|"~     Manual therapy and exercise have shown to be beneficial for people with neck pain, however~     it is not clear how outcomes following a general exercise program compare to specific~     exercises intended to augment a specific manual/hands-on intervention. This study will~     compare outcomes following manual therapy and a specific exercise program with manual~     therapy and a general exercise program.~   "
99758|NCT01751347|"~     The use of local anesthetics has become an important aspect of pain management in surgical~     settings and is currently recommended in pain management guidelines.~      Elective outpatient hand surgeries, such as carpal tunnel or trigger finger release, cause~     minimum tissue disruption and are short in duration. As a result, these local anesthetic~     agents are a major component in post-operative pain control. The most commonly used local~     anesthetic agents are Lidocaine and Bupivacaine. Lidocaine acts faster (within 2-5 minutes~     of injection) and for this reason is often favored in outpatient setting for pre-incisional~     injection. However its effects only last up to 2 hours, without epinephrine, and 3 hours,~     with epinephrine. On the other hand, Bupivacaine, has a slower onset of action (about 5-10~     minutes after injection) but its effects last much longer, for about 4-8 hours. The delay in~     onset of action makes it a less popular option as a primary source of local anesthesia in~     outpatient hand surgery.~      Given the longer duration of anesthesia offered by Bupivacaine, the investigators believe~     that by giving it pre-operatively in elective outpatient hand surgeries will offer more~     effective post operative pain control compared to using Lidocaine only. There is limited~     published data confirming the effectiveness of use of pre-operative Bupivicaine in improved~     postoperative pain control and decreased consumption of narcotics. Therefore, the aim in~     this study is to compare the postoperative pain experienced by patients undergoing either~     elective carpal tunnel release or trigger finger release as well as their use of pain~     medications when the incision site is infiltrated preemptively with Lidocaine versus~     Bupivacaine.~      The investigators believe that adequate post surgical pain control is essential for~     patients' full functional recovery. Poorly controlled post surgical pain increases incidence~     of surgery related complications and thus increased health care costs. It can also reduce~     patients' mobility, delay their return to full function,. If poorly controlled, post~     surgical pain may progress to chronic pain and rarely complex regional pain syndromes may~     ensue.~   "
99759|NCT01751334|"~     The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its~     variability was investigated in this study in order to determine whether a certain landmark~     could be employed as a reference axis for the proximal tibia after rotating platform mobile~     bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).~   "
99760|NCT01751321|"~     Glucose Variability With DPP-4 Inhibition~   "
99761|NCT01751308|"~     Primary Objectives:~      Phase 1 Part:~      To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of~     cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid~     tumors including tumors of the central nervous system.~      Phase 2 Part:~      To determine the objective response rate (complete and partial response) and the duration of~     response to cabazitaxel as a single agent in participants with recurrent or refractory high~     grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).~      Secondary Objectives:~      Phase 1 Part:~      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or~     refractory solid tumors including tumors of the central nervous system.~      To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with~     recurrent or refractory solid tumors including tumors of the central nervous system.~      To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in~     participants with recurrent or refractory solid tumors including tumors of the central~     nervous system.~      Phase 2 Part:~      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or~     refractory HGG or DIPG.~      To estimate progression free survival in participants with recurrent or refractory HGG or~     DIPG.~      To estimate overall survival in participants with recurrent or refractory HGG or DIPG.~      To characterize the plasma PK profile of cabazitaxel in participants with recurrent or~     refractory HGG or DIPG.~   "
99762|NCT01751295|"~     The purpose of this study is to evaluate the effect of statin on the coronary~     microcirculation dysfunction measured after percutaneous coronary intervention.~   "
99763|NCT01751282|"~     The purpose of this study is to determine the effectiveness of Autologous Bone~     Marrow-Derived Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.~   "
99764|NCT01751269|"~     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem~     biapenem to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
99765|NCT01751256|"~     The purpose of this study is to determine wether wound infiltration brings additional~     analgesia effect after cesarean section with optimal standard postoperative analgesia~   "
99766|NCT01751243|"~     Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre,~     prospective, of cohort of patients who will receive different doses of allo-depleted~     lymphocytes .~      This project joins in this pioneering worldwide initiative with its own technology based on~     the use of proteasome inhibitors in vitro, which advantages are, over other methods~     described, the continuing viability of regulatory T cells and the use of a product to~     generate allo-depletion that, contrary to those reported by other research groups, it does~     not pose problems from the point of view of its use or toxicity as we employ a drug widely~     used clinically by intravenous administration.~   "
99767|NCT01751230|"~     The purpose of this study is to help women lose the weight they gained during their~     pregnancy using a SmartPhone app the investigators have developed called E-Moms. The~     investigators hypothesize that the moms given the app to use during the study will lose more~     weight than the moms who do not use the app.~   "
99768|NCT01751217|"~     The current proposal is a randomized clinical trial testing the efficacy of Functional~     Family Therapy (FFT) administered by video teleconference (FFT-V) in the homes of substance~     abusing adolescents. In the proposed investigation, FFT-V will be compared with FFT~     administered face-to-face in the family home as well as to a services-as-usual (SAU)~     condition. The overarching objective of the study is to examine the degree to which an~     empirically based model of substance abuse treatment such as FFT can be effectively~     administered via video teleconferencing to adolescents and families living in rural and~     remote areas who would be otherwise unlikely to access treatment. The specific aims of the~     proposed study are to (1) evaluate the efficacy of FFT-V compared to FFT and SAU in reducing~     adolescent drug use, HIV risk behavior, delinquency, and recidivism, (2) evaluate the~     efficacy of FFT-V compared to FFT in establishing functional levels of therapeutic alliance~     formation, treatment attendance, retention, and satisfaction with treatment, (3) evaluate~     the efficacy of FFT-V compared to FFT and SAU in impacting core mechanisms of change in~     adolescent behavior including improved levels of family functioning and adolescent~     association with substance using peers, and (4) conduct a preliminary cost-effectiveness~     analysis to derive initial estimates of the relative costs of each treatment modality per~     outcome unit.~   "
99769|NCT01751204|"~     The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion~     water.~   "
99806|NCT01750723|"~     In this study the investigators will research the hypothesis that the drug Acetazolamide~     induce headache and dilation of cerebral arteries and increase the cerebral blood flow in~     the areas of the brain supplied by these arteries.~   "
110980|NCT01603602|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in~     pediatric patients with upper limb spasticity.~   "
99770|NCT01751191|"~     Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with~     non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in~     those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values~     or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus~     appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity~     hampers risk stratification and diminishes the cost-effectiveness of assessing the~     hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding~     since in this scenario the risk of rebleeding and of other portal hypertension related~     complications is very high, which calls for early institution of effective therapy.~      Baseline HVPG bears prognostic significance with regards to risk of developing varices,~     decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have~     investigated whether adding data from baseline HVPG may improve the sensitivity of the~     criteria defining a good or poor hemodynamic response.~      Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria~     defining a good or poor hemodynamic response.~      Objective: Exploring the prognostic value of basal HVPG that better discriminate those~     non-responders who do not re-bleed under prophylactic treatment with NSBBs.~      Methods: Observational cohort study. Training set: patients from two longitudinal studies~     conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to~     assess the prognostic value of HVPG changes during continuous therapy with NSBBs for~     preventing variceal rebleeding. Validation set for chronic hemodynamic response: patients~     from two longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the~     Hospital de Sant Pau of Barcelona to assess the prognostic value of HVPG changes during~     continuous therapy with NSBBs for preventing variceal rebleeding; a third cohort composed of~     patients undergoing acute hemodynamic response to intravenous propranolol will be studied.~      All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months,~     and every 6 months thereafter in the original studies.~      End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal~     hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver~     transplantation.~      Ethical aspects: All patients have given their written informed consent to use their data in~     the original studies.~   "
99771|NCT01751178|"~     The aim of this study is to compare subject gingival health after 6 weeks of twice daily use~     of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.~   "
99772|NCT01751165|"~     The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals'~     HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults~     aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals~     longer than two months is not known.~   "
99773|NCT01751152|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active~     Crohn's disease.~   "
99774|NCT01751139|"~     The purpose of this study is to estimate the incidence of dengue infection in children and~     adults in geographically distinct locations of Brazil.~   "
99775|NCT01751126|"~     The objective of this study is to compare the efficacy of two different dosing regimen of~     NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of~     the formulation) administered four times a day in patients with severe vernal~     keratoconjunctivitis after 4 months of treatment.~   "
99776|NCT01751113|"~     The purpose of this study is to evaluate the effects on lung function of a combination of~     ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the~     individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice~     daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over~     design with a 2-week wash-out period between each 4-week consecutive treatment period. The~     aim is to support the rationale for triple combination therapy by demonstrating that~     treatment with both ADOAIR and tiotropium can potentially produce improved, clinically~     relevant effects compared with either treatment alone.~      This study will utilize a range of lung function measures in order to fully assess the~     benefits of triple therapy. The primary endpoint will be based on airways conductance~     measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28).~     Secondary endpoints will include lung function measures based on plethysmography and~     spirometry. The lung function measures will be supported by measurement of the use of relief~     salbutamol .~   "
99777|NCT01751100|"~     The purpose of this study is to see if offering a general health screening tailored towards~     high-risk groups (African immigrants, injection drug users (IDUs), and minority men who have~     sex with men (MSM)) will increase human immunodeficiency virus (HIV) testing, counseling,~     and linkage acceptance rates in community pharmacies.~   "
99778|NCT01751087|"~     The purpose of this research study is to compare three different ways of opening a woman's~     cervix before her second-trimester surgical abortion.~        -  Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open~          the cervix~        -  Osmotic dilators plus mifepristone, a medicine that is swallowed~        -  Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum~      Hypotheses:~        -  adding buccal misoprostol 3 hours preoperatively will significantly improve dilation~          compared to laminaria alone, making procedures faster, easier and safer.~        -  adding oral mifepristone at the time of laminaria placement will confer a similar~          benefit.~        -  the efficacy of adjunctive misoprostol and mifepristone will be influenced by~          gestational age, with women later in gestation having increased efficacy from these~          agents.~        -  significantly more patients who receive adjunctive misoprostol or mifepristone will~          have adequate initial dilation, fewer will require manual dilation or additional~          cervical preparation and there will be fewer complications in these arms, although~          complication rates will be low and we will only be able to detect relatively large~          differences.~        -  patients will prefer to have the procedure done as quickly as possible with as little~          discomfort as possible, that cervical ripening with adjunctive misoprostol will be~          associated with more cramping than osmotic dilators alone and that mifepristone will be~          well tolerated and may not cause more cramping or other side effects than osmotic~          dilators alone.~   "
99779|NCT01751074|"~     The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low~     and it would be helpful to quantify this risk in man in order to guide prescribing~     physicians. The primary aims of this study are to estimate the potential effects of repeat~     doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability.~     Two part approaches are planned for this study. Part A of the study will examine the effects~     of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian~     descent. Based on whether a significant increase in Rosuvastatin exposure is observed in~     Caucasians in Part A, a decision will be made regarding whether to proceed with a~     conditional Part B to examine this effect in healthy volunteers of Far-East Asian descent.~      In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1~     day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling~     period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with~     24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all~     subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1~     day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2)~     while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day~     15 will be analyzed for both Rosuvastatin and Darapladib concentrations.~      Subjects will be required to return to the unit approximately 10 to 14 days following the~     last dose of study medication for a clinic visit for assessments and then will return again~     at 35 ±7 days following the last dose for the final follow-up visit of the study. The~     duration of each subject's participation in the study from screening to follow-up will be~     approximately three months.~      Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will~     be enrolled in Part B (if conducted) to complete dosing and all assessments.~   "
99781|NCT01751048|"~     Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant)~     leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant)~     leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult~     subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the~     safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine~     following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of~     GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the~     immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody~     responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3~     at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about~     18 months.~   "
99782|NCT01751035|"~     Adolescents receiving RRFT and their caregivers will report significantly fewer substance~     use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and~     follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents~     receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk~     and protective factors for substance use and abuse at the individual level (e.g., coping)~     and at each level of an adolescent's ecology (e.g., increased number of positive family~     activities, reduced family conflict, reduced number of peers who use drugs, improved school~     attendance, increased involvement in pro-social community activities) during treatment and~     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will~     experience less PTSD symptoms (per youth and caregiver reports) during treatment and~     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report~     engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during~     treatment and follow-up than control adolescents who receive TAU. Changes during treatment~     in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth~     relationship) and parenting practices (monitoring) will mediate changes in substance use.~     Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.~   "
99783|NCT01751022|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain~     Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant~     procedure. This study will also assess the interactions of the Attain Performa leads with~     the entire Medtronic CRT-D system.~   "
99784|NCT01751009|"~     This study tried to prove that children given food supplements containing vitamin A would~     have better liver vitamin A stores than children given food supplements without vitamin A~     over a 5 month period.~   "
99785|NCT01750996|"~     The goal of the Strongest Families Finland Canada project is to help parents develop skills~     to strengthen their families and reduce disruptive behavior in their 4 year old children.~   "
99786|NCT01750983|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to~     patients with advanced cancer. The safety of these drugs will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~   "
99787|NCT01750970|"~     To confirm the benefit of endoscopic resection under fluorescence and blue light of high~     grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection~     recommended nowadays can be deleted.~   "
99788|NCT01750957|"~     This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the~     safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with~     fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523~     or placebo orally daily for 12 weeks.~   "
99789|NCT01750944|"~     The main objective of this study is to evaluate the concordance of the variation in systolic~     pressure indices measured at the toe and ankle after a walking test in healthy volunteers.~   "
99790|NCT01750931|"~     It is a randomized, balanced, open label, crossover, two period, two treatment, two~     sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured~     by Savipharm J.S.Cc, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH &~     Co. KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy, adult, human male~     subjects under fed condition. It is a pivotal study to demonstrate the bioequivalence of~     Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg~     tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein,~     Germany, in healthy adult human male subjects under fed condition.~      This study will enroll 28 healthy adult human male subjects~   "
99791|NCT01750918|"~     This is an open-label, four-part Phase I/II study to investigate the safety,~     pharmacokinetics, pharmacodynamics and clinical activity of trametinib (GSK1120212) and~     dabrafenib (GSK2118436) when administered in combination with the anti-EGFR antibody~     panitumumab in subjects with BRAF-mutation V600E positive colorectal cancer (CRC) and in~     subjects with CRC with secondary resistance to prior anti-EGFR therapy. Part 1 of the study~     will consist of dose-escalation cohorts, following a 3 + 3 enrollment scheme. Part 2 of the~     study will consist of expansion cohorts to investigate safety and clinical activity of~     dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination~     with panitumumab. Part 3 of the study will be a randomized Phase II study comparing dosing~     with dabrafenib in combination with panitumumab and trametinib plus dabrafenib in~     combination with panitumumab as compared to the chemotherapy comparator (a regimen of~     leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX), leucovorin calcium, fluorouracil,~     irinotecan hydrochloride (FOLFIRI) or irinotecan with or without panitumumab or~     bevacizumab). Subjects will be assigned to treatment groups in a randomized fashion to~     compare safety and clinical activity. Part 4 of the study will investigate the~     trametinib/panitumumab combination, including dose escalation and subsequent cohort~     expansion in two patient populations: 1) BRAF-mutation V600E positive CRC and 2) subjects~     with CRC who developed secondary resistance to prior anti-EGFR therapy. The objective of~     Part 4 is to identify the recommended Phase 2 dose/regimen for trametinib dosed in~     combination with panitumumab in dose escalation and to identify an initial signal of~     clinical activity in expansion cohorts.~   "
111346|NCT01598844|"~     The purpose of this registry is to observe longterm performance and safety of the JenaValve~     TAVI system, in routine medical and everyday conditions.~   "
99792|NCT01750905|"~     The most promising chimeric natriuretic peptide designed and studied by our group has been~     CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal~     volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can~     not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel~     anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.~   "
99793|NCT01750892|"~     This study is looking at ways to help young people with chronic health conditions take~     better care of their health and find an adult doctor.~   "
99794|NCT01750879|"~     The unifying objective of this project is to determine whether peanut oral immunotherapy (PN~     OIT) induced clinical tolerance in the context of food allergy is significantly associated~     with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is~     thought to be inducible in the gut-associated lymphoid compartment and associated with~     immunological tolerance.~      The hypothesis of the study is that the induction of Treg cells will be associated with~     clinical tolerance.~      The investigators will measure the change from baseline of induced Treg cells as a frequency~     of total CD4 T cells during active treatment and compare that between participants who~     achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined~     below) and those who do not (Treatment Failure Group).~   "
99795|NCT01750866|"~     Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in~     patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this~     study is to better understand the response and toxicity of cabazitaxel of elderly men (age~     75 years and older) with advanced prostate cancer who have progressed during or after~     treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous~     (through a vein) infusion plus prednisone by mouth twice daily, and following the~     chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF).~     G-CSF will help the body produce more white blood cells, which should help decrease the risk~     of getting an infection while being treated with cabazitaxel.~   "
99796|NCT01750853|"~     The purpose of this study is to investigate the safety and tolerability of LY3045697 after a~     single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups)~     of 9 participants each will participate in 3 dosing periods. These participants will receive~     placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and~     participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and~     placebo by the end of both periods.~   "
99797|NCT01750840|"~     The purpose of this clinical registry is to capture data on an ongoing basis from a~     population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.~   "
99798|NCT01750827|"~     This will be an open-label, single dose, single period study. Approximately 14 subjects will~     receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.~     This study will evaluate whether SB-659032 has an effect on platelet function as determined~     by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK~     analysis and measurement of Lp-PLA2 activity will also be collected~   "
99799|NCT01750814|"~     The primary objective is to demonstrate the immunological non-inferiority between GC3102C~     and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy~     adults~   "
99800|NCT01750801|"~     Characterization of green propolis and development of mouthwash containing propolis to~     control plaque and gingivitis. A Phase I.~   "
99801|NCT01750788|"~     This is an international observational study in patients with non-valvular atrial~     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent~     stroke or non-central nervous system systemic embolism.~   "
99802|NCT01750775|"~     The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin~     capsule for sinus bradycardia complicated with ventricular premature beats.~   "
99803|NCT01750762|"~     This research is a Phase I clinical trial. Phase I clinical trials test the safety of an~     investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved lenalidomide for your type of cancer.~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, this study will~     determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved~     by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in~     combination with dexamethasone for patients with multiple myeloma (MM) who have received at~     least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in~     a variety of cancer conditions. In this case it is considered experimental.~      There are some participants with multiple myeloma or lymphoma who have had very long~     remissions after a bone marrow/stem cell transplantation from another person. This is~     believed to be the effect of the donor's immune system reaction against the recipient's~     multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it~     might be able to potentiate that reaction. This study is being done to determine if the use~     of lenalidomide is safe in transplant participants and if it can facilitate an immune~     reaction resulting in regression of the myeloma or lymphoma.~      During this study you will be evaluated for side effects from the treatment with~     lenalidomide (including graft versus host disease) and for response of the myeloma to the~     treatment. There will be two groups of participants in the study. The first group will be~     treated at a relatively low dose of lenalidomide. If this is found to be safe then the~     second group will be treated at a higher dose~   "
99804|NCT01750749|"~     Chronic venous leg ulcers (CVU) represent a medical problem associated with significant~     morbidity, increased work absenteeism and earlier retirement as a consequence of disability.~     This strongly affects the patient's quality of life and has a significant economic impact on~     healthcare systems.~      Reports of studies with animal models show that treatment with bone marrow-derived stem~     cells has a beneficial effect in healing chronic skin wounds.~      The purpose of this pilot study is to determine the safety and feasibility of cell therapy~     with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous~     leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot~     study will be used to refine the clinical protocol procedures of a subsequent randomized~     study.~      Patients with venous legs ulcers meeting eligibility criteria and providing appropriate~     written informed consent will be enrolled for study participation. Enrolled patients will~     receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care~     (SOC) treatment.~      During follow up, adverse events will be assessed by ulcer clinical examination.~     Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing~     (reduction of the ulcer area) and pain reduction over a six-month period.~   "
99951|NCT01749085|"~     The study aims to determine what effect a high fat meal will have on the drug exposure of~     PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4)~     inhibitor on drug exposure of PF-04449913.~   "
99807|NCT01750710|"~     This exploratory cross-sectional study proposes, firstly, to objectify in a population of~     Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording~     of electrical parameters and upper limb muscle strength of the thigh and in a second step,~     to seek a relationship between the measured parameters.~   "
99808|NCT01750697|"~     This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the~     safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with~     severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).~     Participants will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously~     (IV) on Days 1, 8, 15 and 22.~   "
99809|NCT01750684|"~     To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses~     over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).~   "
99810|NCT01750671|"~     It is established that the surviving patients after a stay in the ICU are characterized by~     frequent malnutrition and morbidity and mortality. The main goal of this work is to study~     the relationship between nutritional statuses during ICU hospitalization, whatever its~     determinants, and quality of life, morbidity and mortality at one year.~      The hypothesis of the study is that the presence of under nutrition is responsible for a 10%~     increase in crude mortality at one year (which would be respectively 30% for malnourished~     patients and 20% for non-malnourished patients).~   "
99811|NCT01750658|"~     ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200~     patients during a COPD exacerbation.~   "
99812|NCT01750645|"~     Overactive bladder is defined as a syndrome composed of urgency, increased urinary~     frequency, and sometimes urinary incontinence; its etiology may be characterized as~     neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality~     of life and one of the available treatments is the injection of Botulinum Toxin. This study~     aims to review the efficacy and safety of type-A Botulinum Toxin in the management of~     Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL~     and LILACS, and the controlled randomized clinical trials were chosen to review with the~     CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the~     intervention for relieving the symptoms (urgency, frequency and urgency incontinence),~     adverse events to treatment, change in quality of life and urodynamic measures.~   "
99813|NCT01750632|"~     Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed~     testicular tissue is examined for presence of sperm and cryopreserved in small pieces for~     fertility treatment and scientific purposes. Prior to operation blood samples are frozen in~     a biobank.~   "
99814|NCT01750619|"~     To evaluate clinical outcome for patients receiving treatment of suspected premalignant and~     malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome~     is curative endoscopic resection. Secondary outcomes include resection technique utilized,~     rates of en bloc resection and adverse event rates, including infection, bleeding,~     perforation and death, and one-year survival rates.~   "
99815|NCT01750606|"~     Retrospective study to comply with FDA's post-market surveillance order. The purpose of the~     study is to contact patients who have received a Biomet metal-on-metal product as their~     primary total hip arthroplasty device. Patients who have not been revised prior to contact~     will be asked to submit to a blood draw, clinical exam and MRI.~   "
99816|NCT01750593|"~     Thyroid nodules are common problems and although > 95% are stated to be benign, they may~     cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with~     their function, size and localization. Especially for these nodules, patients undergo~     surgery and face up with the problems associated with surgical complications although they~     are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal~     tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign~     thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators~     decided to use this method in our patients having nodules like previously mentioned and see~     the efficacy and safety of the technique.~   "
99817|NCT01750580|"~     To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and~     identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with~     ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.~   "
99818|NCT01750567|"~     Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated~     medication. More recently metformin has been shown to act against carcinomas by two~     mechanisms: 1) an indirect, insulin‐dependent mechanism which sensitizes tissues to insulin,~     inhibits hepatic gluconeogenesis, and stimulates uptake of glucose in muscle, thereby~     reducing fasting blood glucose and circulating levels of insulin, lowering the pro survival~     activity of the insulin/INSR axis, and 2) a direct, insulin‐independent mechanism which~     activates the AMP‐activated protein kinase (AMPK) pathway and leads to inhibition of the~     mTOR pathway. Given the investigators preliminary published data on insulin and mTOR~     inhibition[1] metformin is an attractive candidate for a pilot clinical trial in CLL~     patients.~   "
99819|NCT01750554|"~     The investigators are proposing to continue investigation to improve the accuracy of the~     SpHb (continuous hemoglobin monitoring device) by administering an intermediate acting~     digital nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in~     patients undergoing spine surgery. Bupivacaine is FDA approved and in routine use.~   "
99820|NCT01750541|"~     The aim of this study is to compare the efficacy of haloperidol and valproate in management~     of people with agitation in emergency department~   "
99821|NCT01750528|"~     1. Our hypotheses on the relationship between periodontitis and AS are as follows;~             -  The prevalence of periodontitis is higher in AS patients group than that of non-AS~               control group~             -  Anti-TNF-α therapy would favorably affect the disease course of periodontitis.~        2. Based on our hypotheses, the specific objectives of the present proposal are as~          follows;~             -  The primary objective is to compare the prevalence rate of periodontitis between~               AS patient group and non-AS group.~             -  The secondary objectives will be:~                  -  To observe the carriage rate of P. gingivalis in AS and non-AS groups~                  -  To identify clinical parameters associated with the severity of periodontitis~                    in AS group.~                  -  To compare the progression of periodontitis at weeks 12 and 24 between AS and~                    non-AS groups or between AS patients with and without anti-TNF-α treatment~   "
99822|NCT01750515|"~     Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related~     quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin).~      Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will~     undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant~     immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline~     characteristics(17,18,19). Patients will be randomized into intervention and control groups,~     30 patients each.In the Intervention group each patient will receive an acupuncture~     treatment once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol~     will be individualized for each patient according to TCM diagnosis. This treatment protocol~     is acceptable and has been published(20,21,22).In the control group patients will receive~     standard treatment alone, with no other intervention.~      Data collection: after 12 weeks patients will again undergo Serologic screening for~     hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient~     Ultrasound Elastography (FibroScan) in order to detect changes from baseline and group~     differences.~      Inclusion criteria: adult patients with a confirmed HCV infection~      Exclusion criteria:~      Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason~     Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled~     diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection~     Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1~     year Study Location: Ziv medical center, division of liver disease, Israel~   "
99823|NCT01750502|"~     Macrophage migration inhibitory factor (MIF) is a pleiotropic cytokine that promote the~     inflammatory response.In animal studies, it has been found that MIF is released in the~     ischaemic heart, promoting glucose uptake and protecting the heart from~     ischaemia-reperfusion injury.The MIF concentration, influenced by age and myocardial~     ischemia, have different impact on myocardial functional recovery after ischemia.Therefore,~     the purpose of this experiment is to study the clinical significance of MIF in patients with~     coronary heart disease.~   "
99824|NCT01750489|"~     The objective of the project is to better understand the causes of exercise limitation,~     dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators~     aim to explore the mutual interaction of neurohumoral activation and exercise limitation~     thereby focussing on differential effects of the peripheral muscle and the diaphragm.~      Eventually the findings might influence treatment modalities. If sympathetic activation~     contributes to exercise limitation then drugs influencing the autonomic nervous system would~     be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an~     alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to~     improve dyspnea and exercise capacity.~   "
99825|NCT01750476|"~     The investigators are conducting a research study to understand how cells responsible for~     fighting infection (immune cells) are affected by hormonal contraceptive use. The~     investigators hypothesize that progestin-containing hormonal contraceptives (i.e.,~     Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators~     will collect blood and genital tract samples from women before and after their initiation of~     a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).~   "
99826|NCT01750463|"~     This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive~     Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin~     concentration in critically ill children.~   "
99827|NCT01750450|"~     The investigators will generate pressure-flow loops and pressure-volume loops from aortic~     and left ventricular pressure waveforms and Doppler (desc. aorta) flow waveforms and compare~     left ventricular to arterial pressure-flow and pressure-volume loops as well as to cardiac~     power from the USCOM 1A device. The goal of this study is to test the hypothesis that~     non-invasive estimates of cardiac pressure-volume work (derived from ultrasound-based~     measurements) correlate with invasive estimates.~   "
99828|NCT01750437|"~     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to~     investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive~     reflux disease(NERD)~   "
99829|NCT01750424|"~     The purpose of this study is to assess scar-formation and wound healing following the use of~     autologous fat grafting in facial reconstruction patients. Patients who have undergone~     facial reconstruction in the last 3 months will be randomized into two groups, one receiving~     fat grafting and one not receiving any intervention. These patients will continue to~     follow-up in our clinic for one year, with 3-D images taken at each follow-up visit to~     assess scar formation and wound healing. Assessment of the scar will be undertaken by both~     healthcare personnel as well as general lay public. We hypothesize that patients undergoing~     fat grafting to the wound site will achieve a more aesthetically appealing result, with less~     scarring and improved wound healing as judged by both the general public and healthcare~     professionals.~   "
99830|NCT01750411|"~     The mission of SARP is to improve the understanding of severe asthma through the integrated~     study of the effect of genetics on the clinical and biological features of asthma and to~     investigate how these change over time. The ultimate goal of these efforts is to promote~     better treatments for severe asthma.~   "
99831|NCT01750398|"~     The purpose of this study is to determine the safety and clinical effects of alternating~     androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer~     as first line hormonal therapy, to assess the effect of alternating therapy on quality of~     life and metabolic changes associated with androgen-deprivation therapy.~   "
99832|NCT01750385|"~     Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia~     because it is safer and more effective than traditional Heller's myotomy. However, the issue~     of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore,~     we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin~     levels in order to preliminary observe whether antibiotic prophylaxis is needed.~   "
99845|NCT01750203|"~     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects~     who have wounds that show clinical signs of infection, as well as from Subjects who have~     wounds that do not show clinical signs of infection. Swab samples will be collected from~     acute and chronic wounds of different etiologies and these will be analysed for bacteria~     types and markers of infection.~   "
111347|NCT01598831|"~     The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis~     can decrease mortality.~   "
99833|NCT01750372|"~     Standardized outcome measures can be used to document patient health outcomes and improve~     treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous~     instruments have been developed, existing measures of O&P outcomes have serious shortcomings~     including limited evidence that the scores are responsive to clinical changes.~      The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using~     modern measurement methods to be a brief, precise and flexible measure of mobility for~     persons with lower limb amputation (LLA). The investigators propose the following objectives~     to achieve this goal.~      Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower~     limb loss~      Key objective 2: study health profiles of lower limb prosthetic users~      Key objective 3: validate the measure in a longitudinal study of people receiving~     replacement prosthetic limbs~      Key objective 4: study longitudinal health patterns of persons with lower limb amputation~   "
99834|NCT01750359|"~     Antidepressants generally do not lead to an immediate relief of symptoms. Most people will~     not see a significant improvement for at least 4 weeks. Studies have generally shown that~     the full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this~     timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated~     from this perennial herb. It possesses a variety of pharmacological activities, including~     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has~     been found to possess antidepressant action in various animal models of depression. Chronic~     administration of curcumin has been reported to exert antidepressant-like action in~     olfactory bulbectomy model of depression in rats. Although the mechanism of the~     antidepressant effect of curcumin is not fully understood, it is hypothesized that it acts~     through inhibiting the monoamine oxidase enzyme and modulating the release of serotonin and~     dopamine.In randomized, double-blind, placebo-controlled study 40 patients will be~     randomized to receive either 500 mg/day of curcumin or placebo together with antidepressants~     for 6 weeks.~   "
99835|NCT01750346|"~     Background:~      - Blepharospasm is caused by excessive contraction of the muscles that close the eye. One~     treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT,~     acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream.~     AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles.~     Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original~     dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to~     see if it can be a more effective treatment.~      Objectives:~      - To see if AH-8 cream can improve the symptoms of blepharospasm.~      Eligibility:~      - Individuals at least 18 years of age who have blepharospasm that is severe enough to~     require treatment.~      Design:~        -  This study will involve up to eight study visits.~        -  Participants will be screened with a physical exam and medical history. They will~          answer questions about their symptoms. They will also have a blink test to see how~          severe the blepharospasm is. At this visit, participants will receive one of three~          types of cream. One cream will have a low dose of AH-8, one will have a higher dose of~          AH-8, and the other will be a placebo (no AH-8).~        -  One month later, participants will have a followup visit, with tests similar to the~          first visit. They will also receive more of the cream.~        -  One month later, participants will have another visit with the same tests. They will be~          videotaped at this visit to study their facial movements. Those who have responded to~          the treatment will continue to use the cream. Those who have not responded will be~          offered the chance to have BoNT injections, and will stop taking the cream.~        -  One month later, participants who had BoNT injections will have a final visit to check~          for possible side effects. Those who continued to take the cream will continue on the~          study.~        -  The fifth and sixth visits will involve the same tests as before. At the seventh visit,~          remaining participants will be offered the chance to have BoNT injections, and will~          stop taking the cream.~        -  The final visit will check for any side effects from the cream or the injections.~   "
99836|NCT01750333|"~     The aim of this study is to explore whether and how high circulating levels of endothelin-1~     (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad)~     production, release and vascular activity~   "
99837|NCT01750307|"~     Brief summary~      The aim of the study is to provide preliminary data on the relationship of Essential Fatty~     Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural~     functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This~     main aim will be achieved in two ways. First the investigators will measure the relationship~     of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the~     potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and~     behavioural measures in ADHD cases will be investigated. We will evaluate the extent to~     which changes in neuronal activity and cognitive performance are related to behavioural and~     functional measures over time. This is to be carried out by conducting a randomised~     controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and~     Cognitive Effects in Adult Neurodevelopment).~      The study design will be a 6-month double blind placebo control study with a group of 80~     adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive~     EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA~     dietary supplementation and placebo groups will be randomly allocated and blind to both the~     investigator and participants. In addition a sample of 30 controls will take part in~     baseline levels of assessment and be used for case-control comparisons to investigate the~     links between EFA blood levels and cognitive-electrophysiological function at one time~     point.~      The study design will enable preliminary data to address the following hypotheses:~        1. Changes in cognitive and electrophysiological function (neuronal activity) will be~          found following supplementation with dietary EFAs.~        2. Changes in cognition and/or brain activity will be related to blood levels of EFAs.~        3. Changes in cognitive performance and electrophysiological parameters will correlate~          with behavioural function, affective regulation or functional impairments.~        4. At baseline, case-control differences in EFA blood-levels will be found which will be~          linked to cognitive and electrophysiological function.~   "
99838|NCT01750294|"~     It is estimated that in the United States there are approximately 8 million individuals with~     moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an~     important role in the pathogenesis of hypertension in patients with CKD. For this pilot~     study, the investigators hypothesize that administration of chlorthalidone among patients~     with moderate to severe CKD will improve blood pressure (BP).~   "
99839|NCT01750281|"~     The purpose of this study is to treat patients with locally advanced or metastatic NSCLC~     with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60~     mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will~     also help us to understand the tolerability profile of the different dosing regimens in~     these patients~   "
99840|NCT01750268|"~     The goal of the proposed project is to improve the treatment of veterans with co-occurring~     traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and~     coinvestigators will conduct a pilot controlled clinical trial of topiramate for the~     treatment of these co-occurring disorders.~   "
99841|NCT01750255|"~     This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve~     compliance and adherence rate, associated with greater effectiveness and safety of drug~     therapy to help achieve therapeutic goals, and finally to improving the quality of life of~     patients.~   "
99842|NCT01750242|"~     To evaluate DBS device settings and match with the features of the DBS care management~     software.~   "
99843|NCT01750229|"~     The purpose of this study is to evaluate the role of frequency settings on spinal cord~     stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).~   "
99844|NCT01750216|"~     This observational study will evaluate the predictive value of rapid virological response~     (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage~     of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated~     on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be~     followed for 48 weeks of treatment and up to 24 weeks of follow-up.~   "
99847|NCT01750177|"~     The purpose is to investigate the effect of sedentary screen time activities on food intake~     and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The~     investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes~     increases subjective appetite and food intake at the next meal. Food intake will be measured~     immediately following screen-time exposure, and subjective appetite measured throughout the~     study period at 0, 15, 30, 45 and 75 minutes.~   "
99848|NCT01750164|"~     This study will use tissue or body fluid acquired during standard procedures that are part~     of the patient's care for their cancer, such as surgery to remove tumor tissue or needle~     withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into~     immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The~     tissue will then be extracted and either frozen, embedded in paraffin, or used for~     engraftment into another generation of mice. The second generation mice will be separated~     into groups and given various treatments.~      Tissue from the participants and from the mouse established tumors, in which the mice have~     either received treatment or have not received treatment, will be used to evaluate the~     levels of various genes that assist in regulating cell growth and cell death. The tumor~     tissue from participants and mice will also be tested for random changes in the genetic~     material and compared to the participant's blood to determine if any of the changes in the~     genetic material correlate with better engraftment of the patient tissue in the mice. It is~     anticipated that 10-30% will have successful engraftment of tumor tissue~   "
99849|NCT01750151|"~     The purpose of this experiment is to investigate the effect of video game playing for 30~     minutes on food intake and subjective appetite. The investigators hypothesize that video~     game playing will affect food intake in children. Food intake will be measured at 30 minutes~     following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg~     Sucralose® in 250ml of water) beverage with or without video game playing. Subjective~     appetite will be measured at 0, 20, 35 and 65 minutes.~   "
99850|NCT01750138|"~     The gastrointestinal tract has many functions; it provides nutrition, produces hormones,~     performs a barrier function, maintains a stable gastrointestinal micro flora and plays an~     important role in the inflammatory process as it is the largest producer of cytokines~     (proteins associated with inflammation). This gut function is impaired after colorectal~     (bowel) surgery. There is evidence to suggest that impaired gut function is associated with~     increased complications. Hence if gut function is preserved, it should equate with better~     outcomes. As a result, there has been increasing interest in treatments called Gut Specific~     Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine,~     a conditionally essential amino acid and preferred fuel source for intestinal cells.~     Research has shown that glutamine promotes cell growth, increases clearance of harmful~     organisms from the blood, and reduces the surgical stress response. In other words,~     glutamine has a favourable influence on gut function.~      Recent studies from our unit using intravenous glutamine in critically ill patients have~     shown an early return of gut function, which in turn is associated with attenuation of the~     inflammatory response and improved outcomes. It is not known whether oral glutamine is~     associated with a similar outcome. A recent pilot study at our unit suggests an association~     between oral glutamine and early return of gut function. The aim of this research is to~     determine if giving oral glutamine results in an early return of gut function and whether~     this is associated with an attenuation of the systemic inflammatory response.~   "
99851|NCT01750125|"~     The investigators hypothesize that performance of fast-Fourier transformation on the raw~     Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave~     Doppler trace visualized on modern echocardiography machines, and that this will allow for~     the measurement and recording of vascular flow waveforms~   "
99852|NCT01750112|"~     This is a prospective, open, non-comparative and baseline-controlled study to evaluate~     efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum~     deformity.~      Each subject participating in the study will be treated with approximately 50-150 ml of~     Macrolane VRF20. The amount of study product used will be individually determined in order~     to achieve an optimal correction of the deformity in each subject.~   "
99853|NCT01750099|"~     This study divides patients into two groups when they ask for medicine to help relieve the~     pain of contractions. One group will be selected to receive an epidural and another group~     will be selected to receive both a spinal dose and an epidural. The investigators will then~     measure how long it takes to deliver the baby. The investigators think that the group that~     has the combination spinal and epidural will have a faster labor.~   "
99854|NCT01750086|"~     The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis~     medications when combined with teriparatide.~   "
99855|NCT01750073|"~     This phase II trial studies the side effects and how well giving paclitaxel and~     cyclophosphamide with or without trastuzumab before surgery works in treating patients with~     previously untreated stage I-III breast cancer. Drugs used in chemotherapy, such as~     paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such~     as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving combination chemotherapy with or without trastuzumab before~     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be~     removed~   "
99856|NCT01750060|"~     This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence~     design. A total of 54 eligible subjects will receive three total treatments; one with~     intravenous (IV) infusion and two with the Study System. Each subject will be randomly~     assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate),~     Study System Treatment B (170 mcAmp), and one of three additional Study System treatments~     (140 mcAmp or 200 mcAmp or 230 mcAmp) ~   "
99896|NCT01749800|"~     The overall goal of the proposed project is: (1) to perform a preliminary study to determine~     optimal galvanic vestibular stimulation (GVS) settings based on performance of one cognitive~     test of attention, and (2) to gather preliminary evidence of the effects of GVS in~     combination with computer-based attention training and motor training performed using a~     robotic system designed for rehabilitation, in a small cohort of TBI survivors (20~     subjects).~   "
99857|NCT01750047|"~     Object: Every person's pain perception and possible postoperative pain is different. As the~     investigators know, they are affected by many factors. However, the investigators don't know~     whether the smoking factors, alcohol factors, surgery type, education background, etc. will~     affect individual pain perception and possible postoperative pain in Chinese population.~     This study was conducted to investigate the power of these possible affect factors. Method:~     Patients receiving elective surgery under general anesthesia were recruited into this study.~     The investigators measured their preoperative pressure pain threshold (PPT) and pressure~     pain tolerance (PTO)and also investigated the patient's personal information of smoking~     factors, alcohol factors, surgery type, education background, etc. In addition, we~     retrospectively investigated the visual analog scale (VAS) during patient-controlled~     analgesia (PCA) treatment 0 to 48 h after operation as well as the PCA press frequency and~     drug consumption of those patients who received PCA administration.~   "
99858|NCT01750034|"~     The purpose of this study is to better understand how to best care for burn wounds.~   "
99859|NCT01750021|"~     Obesity has become a global epidemic, and treating and preventing obesity appears to be one~     of the world's greatest challenges. The disorder is associated with a wide range of~     metabolic and hormonal changes, including the development of insulin resistance, changes in~     adipose tissue function, increased levels of blood lipids, cardiovascular disease and~     obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue,~     altered fat storage capacity and increased exchange of lipids between adipose tissue and~     blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to~     play a central role in the regulation of adipose tissue, the size of adipocytes and other~     metabolic conditions.~      The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for~     the body's energy storages. The central role of the liver in energy supply, fat storage and~     normalization of blood values implies the importance of investigating the interaction~     between adipose tissue and liver to increase knowledge about the morbidity of obesity.~     Central obesity and insulin resistance are clear risk factors for the development of fatty~     liver, but the importance of diet is unclear. The common perception is that fatty liver~     condition can be improved by a reduction in dietary fat and cholesterols, but the~     relationship is unclear, and contradictory findings occur in epidemiological studies. It is~     therefore necessary to better understand the impact of the different macro-nutrients.~      The purpose of this study is to determine whether two weight reducing diets with equal~     calorie levels that contain high or low fat differentially affects the adipose tissue~     function, distribution of body fat, as well as tissue, blood and urine levels of~     inflammatory markers, lipids, vitamins, hormones and other substances that may be related to~     metabolically health.~   "
99860|NCT01750008|"~     The purpose of this study is to compare the outcomes of two uterine-conserving treatment~     alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global~     fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard~     step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating~     laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have~     equal access to valuable imaging information and to plan treatment accordingly. By~     randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one~     treatment or the other following the LUS is eliminated.~   "
99861|NCT01749995|"~     A Comprehensive Geriatric Assessment (CGA) has become a fundamental aid in the evaluation~     and treatment planning of older cancer patients. Systematic reviews of trials of geriatric~     assessments have shown effectiveness when interventions are implemented. Although CGA is a~     fundamental tool in the care of the geriatric patient, the integration and application of~     this tool in oncologic practice are still in evolution. Cognition is one of the domains~     examined within a CGA. Studies have noted that up to 25% to 50% of older patients had~     cognitive abnormalities that warranted further evaluation. Cognitive dysfunctions can~     influence the ability to weigh the risks and benefits of cancer therapy, to comply with the~     suggested treatment plan, and to recognize the symptoms of toxicity that need medical~     attention. Recently, the Freund Clock Drawing Test (CDT) has been proposed as a quick and~     simple screening tool to assess cognitive dysfunction. A retrospective analysis on 105~     cancer patients at the General Hospital Groeninge showed that a cut-off score of ≤ 4 for the~     CDT has a good AUC, sensitivity and specificity.~      Aims~        1. To validate the Clock Drawing Test as a screening tool to identify elderly cancer~          patients in need of a more in-depth cognitive evaluation within a comprehensive~          geriatric assessment (CGA)~        2. Further registration of data in a database coupled to the Cancer Registry in the~          General Hospital Groeninge as set up by the PROGERCAN study~   "
99862|NCT01749982|"~     Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking~     water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L.~     Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart~     disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies~     on one-carbon metabolism and involves two methylation steps; both utilize~     S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins~     including folate and B12 for the recruitment and transfer of methyl groups, but other~     nutrients, including choline and betaine, also contribute to the methyl pool. Our recent~     findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As~     concentrations in drinking water show that plasma choline and betaine concentrations are~     positively associated with As methylation. These findings suggest that choline and/or~     betaine may play an important role in As methylation and elimination and that simple~     interventions may have therapeutic potential for the many populations at risk for As-induced~     health effects.~      The investigators aim to recruit and follow 60 participants for this pilot study which will~     allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor~     participants for any potential side effects, 3) identify any difficulties that might be~     encountered in daily follow-up, and 4) generate preliminary data regarding the effects of~     choline and/or betaine supplementation on arsenic methylation.~   "
99897|NCT01749787|"~     The purpose of this study is to determine the safety and tolerability of PRTX-100 when~     various doses are given 5 times at weekly intervals to patients with active rheumatoid~     arthritis that are taking methotrexate or leflunomide. The drug is administered in a~     physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid~     arthritis by suppressing the immune responses.~      PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this~     study, cohorts of patients with active RA will receive sequentially higher doses of~     PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not~     attain low RA disease activity, by a commonly used measure, will leave the study at 3 months~     after their first dose of study drug.~   "
100003|NCT01748149|"~     This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a~     recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory~     gliomas containing the BRAFV600E or BRAF Ins T mutation.~   "
99863|NCT01749969|"~     Primary Objectives:~        -  To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and~          dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.~        -  Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity~          (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using~          International Myeloma Working Group (IMWG) criteria.~      Secondary Objectives:~        -  To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in~          combination with LD in relapsed or refractory multiple myeloma. The severity, frequency~          and incidence of all toxicities will be assessed.~        -  To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in~          combination with LD and the PK of lenalidomide in combination with SAR650984 and~          dexamethasone.~        -  To assess the relationship between clinical (adverse event [AE] and/or tumor response)~          effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic~          (correlative laboratory) results.~        -  For the dose expansion phase, estimate the activity (ORR) using IMWG defined response~          criteria of SAR650984 (isatuximab) plus LD.~        -  To describe progression-free survival (PFS) in patients treated with this combination.~   "
99864|NCT01749956|"~     The purpose of this Phase II study will be to investigate the antiangiogenic agent,~     aflibercept, in combination with chemoradiation as preoperative treatment for patients with~     stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.~   "
99865|NCT01749943|"~     Evaluate a method of testing the strength of five key lower limb muscle groups using a~     hand-held strength gauge (dynamometer).~   "
99866|NCT01749930|"~     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),~     the primary objective is to demonstrate that the mean IOP reduction after 3 months of~     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice~     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to~     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of~     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will~     be conducted at the end of Visit 6 (3 months) where all participants will receive~     BOL-303259-X QD for an additional 3 months.~   "
99867|NCT01749917|"~     The investigators conducted an intervention based in proprioceptive exercises and balance~     tasks. The investigators also carried out a brief intervention in manual dexterity.~      The study hypothesis is that a brief intervention in upper extremities and a exercise~     program can increase functionality in Parkinson.~   "
99868|NCT01749904|"~     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),~     the primary objective is to demonstrate that the mean IOP reduction after 3 months of~     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice~     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to~     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of~     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will~     be conducted at the end of Visit 6 (3 months) where all participants will receive~     BOL-303259-X QD for an additional 9 months.~   "
99869|NCT01749891|"~     The general objective of this study is to evaluate the safety and efficacy of ophthalmic~     intravitreal injections of ALG-1001 in human subjects with wet age-related macular~     degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous~     animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema~     patients.~   "
99870|NCT01749878|"~     Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind~     study of the safety, tolerability, and bioeffect of REGN1500~   "
99871|NCT01749865|"~     This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who~     underwent radical resection will be included. The patients will be randomized to group A~     (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer~     treatment after resection of HCC, and the randomize ratio will be 1:1.~   "
99872|NCT01749852|"~     The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body~     weight/ body fat in the overweight and obese adult population.~   "
99873|NCT01748864|"~     A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in~     normal volunteers. Study will determine biodistribution and excretion of the radioactive~     drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal~     volunteers.~   "
99874|NCT01748851|"~     The purpose of this study is to identify the non-inferiority of the combination therapy of~     Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic~     acid and Oxaliplatin in patients with advanced gastric cancer.~   "
99875|NCT01748838|"~     The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules~     taken orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat~     lung inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1~     assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will~     include several dosages. During the single-dose part of the study, following a 14-day~     washout period, two cohorts will be assessed for potential effects on tolerability when fed~     at the time of dosing. For both parts of the study, blood samples will be collected for PK~     assay validation.~   "
99898|NCT01749774|"~     The purpose of this study is to determine the feasibility and effect of a program including~     information, counseling and an individualized physical activity program on physical and~     psychological health during and after chemotherapy in patients with testicular cancer. It is~     hypothesized that the patients are able to complete the intervention with individual~     adjustments.~   "
99899|NCT01749761|"~     It is very common for hemodialysis patients to have problems with low blood pressure while~     on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated~     with an increased risk of death and hospitalizations. It might be possible to minimize or~     even prevent these low blood pressure episodes with a software that can be added to the~     dialysis machine which detects the patient's changes in blood pressure and automatically~     slows down how much fluid is being removed from the person.~      The investigators hypothesize that a blood pressure guided biofeedback system (called~     BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on~     hemodialysis.~   "
99876|NCT01748825|"~     BACKGROUND:~        -  Wee1 is a tyrosine kinase involved in the phosphorylation and inactivation of~          cyclindependent kinase 1 (CDK1/CDC2)-bound cyclin B, resulting in G2 cell cycle arrest~          in response to DNA damage to allow time for DNA repair. Recent preclinical data~          additionally implicates Wee1 in maintenance of genomic integrity during S phase.~        -  AZD1775 (MK-1775) is a selective inhibitor of Wee1 kinase. Recent preclinical model~          data additionally show single agent anti-tumor activity in multiple cancer cell lines~          and tumor xenografts.~        -  Preliminary data show AZD1775 (MK-1775) is tolerable at lower doses in combination with~          chemotherapeutic agents. We propose to demonstrate single-agent activity for AZD1775~          (MK-1775).~      PRIMARY OBJECTIVE:~        -  To establish the safety and tolerability of single-agent AZD1775 (MK-1775) in patients~          with refractory solid tumors~        -  To determine the pharmacokinetics of AZD1775 (MK-1775) in patients with refractory~          solid tumors~      SECONDARY OBJECTIVES:~        -  To determine the effect of AZD1775 (MK-1775) on markers of DNA damage and apoptosis in~          tumor tissue and circulating tumor cells~        -  To evaluate the antitumor activity of AZD1775 (MK-1775) in patients with refractory~          solid tumors~      ELIGIBILITY:~        -  Patients must have histologically confirmed solid tumors for which all standard therapy~          known to prolong survival have failed, or for which standard therapies do not exist.~        -  No major surgery, radiation, or chemotherapy within 4 weeks prior to entering the study~        -  Adequate organ function~      Study Design:~        -  This study will follow a traditional 3+3 design.~        -  In Cohort A starting at dose level 1, AZD1775 (MK-1775) will be administered orally,~          BID, for 5 doses (D1-3) during each cycle. Starting at dose level 2 and onwards,~          AZD1775 (MK-1775) will be administered orally, BID, for 5 doses for the first 2 weeks~          of each cycle (D1-3 and 8- 10). Each cycle is 21 days ( 1 day for scheduling).~        -  Once MTD is established, 6 additional patients will be enrolled at the MTD to further~          evaluate that dose for PK and PD endpoints.~        -  A further expansion cohort of 6 additional patients with documented tumors harboring~          BRCA-1 or -2 mutations will lso be enrolled at the MTD to further explore the safety of~          the agent and obtain preliminary evidence of activity in this patient population.~        -  Based on preliminary evidence of drug activity in an alternative once-daily dosing~          schedule, patients without a documented BRCA mutation will be accrued to a once-daily~          dosing schedule Cohort B, for up to two dose levels, with mandatory paired tumor~          biopsies at the maximum tolerated single daily dose, to further evaluate PD endpoints.~          AZD1775 (MK-1775) will be administered orally once daily for 5 days (D1-5 and 8-12)~          during weeks 1 and 2 of each 21-day cycle ( 1 day for scheduling).~        -  During the escalation phase, tumor biopsies will be optional and will be evaluated for~          pharmacodynamic (PD) studies for evidence of DNA damage, repair, and apoptosis (H2AX,~          pNbs1, ERCC1, and caspase 3). During the expansion phase, once MTD is reached,~          mandatory paired tumor biopsies will be pursued in the 6 additional patients enrolled~          at the MTD to further evaluate PD endpoints.~      <TAB>~   "
99877|NCT01748812|"~     Background:~        -  Hypophosphatemia is a condition where a person has low levels of phosphorus in the~          blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and~          teeth problems. One cause of the condition is having too much fibroblast growth factor~          23 (FGF23). FGF23 is a hormone that causes the kidney to get rid of phosphorus in the~          urine. It can also prevent the body from making vitamin D, which helps the body absorb~          phosphorus in food.~        -  Many people with low blood phosphorus take high doses of phosphorus and calcium~          medications. However, one side effect of these drugs is increased blood levels of~          parathyroid hormone (PTH). The drug cinacalcet can help lower PTH levels, which may~          decrease the amount of phosphorus lost in the urine and increase the phosphorus levels~          in the blood. Researchers want to see if cinacalcet can help blood phosphorus and~          decrease the amount of phosphorus supplements that people need to take.~      Objectives:~      - To see if cinacalcet can be a safe and effective treatment for people with low phosphorus~     conditions due to high FGF23.~      Eligibility:~      - Individuals between 18 and 70 years of age who have different forms of hypophosphatemic~     rickets and tumor-induced hypophosphatemia~      Design:~        -  Participants will have up to 25 study visits over about 28 weeks.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Up to three more lab visits for blood and urine tests will be required before~          treatment. Imaging studies of the bones, spine, and kidneys will be performed.~        -  Participants will have a 3-night hospital stay to start treatment. They will take~          cinacalcet once a day. Treatment will be monitored with frequent blood tests and~          imaging studies.~        -  Participants will continue to take cinacalcet once a day for 3 weeks. They will have~          regular study visits to monitor the treatment.~        -  There will be up to two other overnight hospital stays (1 to 3 nights) to adjust~          cinacalcet doses. The dose will increase until the maximum dose is reached, or side~          effects develop.~        -  After the end of the cinacalcet study, participants will have several more followup~          visits to monitor the effects of treatment.~   "
99878|NCT01748799|"~     The purpose of this study is to to demonstrate the feasibility and tolerability of the use~     of Sativex in cannabis dependent individuals and to assess the effects of fixed or self~     titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal~     spray) on withdrawal symptoms, craving scores and cannabis consumption during the study~     period.~   "
99879|NCT01748786|"~     The purpose of this study is to compare an online 12-module intervention designed to improve~     emotion regulation and social relations via mindfulness training with a 12-module program~     that provides information about health behaviors to individuals with fibromyalgia. The~     mindfulness training program is expected to produce greater day-to-day improvements than the~     education condition in individuals' efficacy for coping with pain and stress, positive and~     negative affect, and positive engagement in social relations assessed via online diaries~     completed each evening during the intervention period.~   "
99880|NCT01748773|"~     This single arm, open-label study will evaluate the safety and efficacy of the combination~     oxaliplatin, capecitabine and Herceptin (trastuzumab) and chemoradiotherapy in the adjuvant~     setting in patients with curatively resected HER2-positive gastric or gastro-esophageal~     junction cancer. Patients will receive Herceptin 8 mg/kg intravenously (iv) on Day 1 of~     Cycle 1 and 6 mg/kg iv on Day 1 of every following 3-week cycle, with oxaliplatin 100 mg/m2~     iv on Day 1 of Cycles 1-3 and capecitabine 850 mg/m2 orally twice daily on Days 1-14 of~     Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a~     total dose of 45 Gy divided into 25 doses on 5 treatment days each week for 5 weeks starting~     Day 22 of Cycle 3. Anticipated time on study treatment is 1 year.~   "
99881|NCT01748760|"~     This study is to develop an adjunctive intervention for acutely suicidal adolescents who~     have been admitted to a psychiatric inpatient unit. The study intervention is comprised of:~     1) two to three individual sessions delivered in an inpatient setting or immediately upon~     discharge; 2) one family session; 3) six months of follow-up phone interventions. The~     investigators hypothesize that those who receive the study intervention will have lower~     rates of suicide events and greater decreases in suicidal ideation after six months.~   "
99882|NCT01748747|"~     This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with~     stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help~     the body build an effective immune response to kill tumor cell tumor cells. Biological~     therapies, such as resiquimod, may stimulate the immune system in different ways and stop~     tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and~     resiquimod are more effective when given together or separately~   "
99883|NCT01748734|"~     The purpose of this study is to learn about treatment of depression in people who have any~     type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting~     patient's thoughts and behaviors. People who are depressed tend to have more negative or~     pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By~     encouraging patients to develop more balanced views, symptoms of depression begin to improve~   "
99884|NCT01748721|"~     This phase I trial studies the side effects and best dose of MORAb-004 in treating young~     patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such~     as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
99900|NCT01749748|"~     To delineate if the chemical composition (lipid and water) in the presumably normal breast~     of the high risk women is different from those of the low risk group.~   "
100004|NCT01748136|"~     That computed tomography (CT) screening of HIV-seropositive heavy smokers will detect early~     stage lung cancer at significantly higher rates than what is currently being observed.~   "
99885|NCT01748708|"~     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression that~     is resistant to common modalities of treatment, such as antidepressant medication. Although~     treatment with ECT has benefited many individuals with treatment resistant depression (rates~     as high as 50-75%), its more widespread use is hindered by the social stigma associated with~     the treatment, as well as by its significant cognitive side effects. Moreover, ECT cannot be~     precisely targeted, since it produces a widespread activation of the brain surface, in turn,~     affecting many different functional areas. Magnetic seizure therapy (MST) is currently being~     investigated as an alternative to ECT, as it is more focused to one area of the brain.~     Rather than applying electrical stimuli to induce a seizure, as is done in ECT, MST uses~     repetitive magnetic stimulation to produce the seizure. Preliminary research suggests that~     MST can result in therapeutic effects comparable to those produced by ECT, but without the~     negative side effects on cognition. The proposed study is a randomized, controlled trial, in~     which the efficacy and side effect profile of MST will be compared to those of ECT. If~     successful, the results of this study may lead to increased treatment availability and~     accessibility, as well as lessen the substantial health care costs associated with treatment~     resistant depression.~   "
99886|NCT01748695|"~     The purpose of this study is to investigate whether V158866 is safe and effective for the~     treatment of neuropathic pain due to spinal cord injury.~   "
99887|NCT01748682|"~     Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the~     reduction of comorbidities associated with surgical act, such as decreased visceral fat,~     liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to~     be employed in this period need to be defined more clearly. As there is no description of~     comparative studies on diet of normal consistency, using solids and liquids, there are~     doubts as to the real need for consistency liquid diet in preoperative bariatric surgery.~     The lack of robust evidence has made nutrition professionals adopt different procedures.~     There is still a belief that these patients are unable to lose weight in the preoperative~     period, the ongoing history of previous attempts without success.~   "
99888|NCT01748669|"~     Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated~     with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body~     arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed~     controls and healthy volunteers will be included for comparison.~   "
99889|NCT01748656|"~     Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive~     positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of~     automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a~     pre-determined ideal tidal volume or ideal ventilation. However algorithms used to~     achieve these ideal targets are different among different commercialized devices and the~     relative efficacy from an algorithm compared to another remains unknown. The main objective~     is this study is to compare two commercialized NIPPV that have this option~   "
99890|NCT01748643|"~     The purpose of this study is to investigate if a deep neuromuscular block with a continuous~     infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with~     reversal of neuromuscular blockade with sugammadex results in improved surgical conditions~     for the surgeon and/or improved post-operative respiratory function for the patients as~     compared to a standard technique with an intubation dose of rocuronium and top-ups as needed~     to maintain a neuromuscular blockade with a TOF count of 1-2 and reversal of neuromuscular~     blockade with neostigmine/glycopyrrolate.~      Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium~     and reversal with sugammadex or neostigmine/glycopyrolate on cerebral tissue oxygenation.~   "
99891|NCT01748630|"~     Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam~     for sedation during the early postoperative period in children who underwent scoliosis~     surgery.~      Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a~     tertiary care center. In this study, 42 patients (American Society of Anesthesiology~     physical status I and II) who underwent scoliosis surgery were divided into 2 groups~     according to sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18~     years) requiring mechanical ventilation underwent a continuous infusion of either~     dexmedetomidine (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ;~     starting dose, 0.1 mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of~     sedation was assessed using the Richmond Agitation Sedation Scale (RASS). Quality of pain~     relief was measured using the Numeric Visual Analog Scale (NVAS). During the arousal~     assessment, delirium was determined in patients in the RASS range of -2 to +1 using the~     Confusion Assessment Method for the ICU (CAM-ICU). Fentanyl consumption, incidence of~     delirium, NVAS scores, and hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h~     in the ICU.~   "
99892|NCT01748617|"~     This study will be a randomized, double-blind, crossover intervention to investigate the~     health effects of acute ingestion of pomegranate juice when consumed with a high fat meal.~     After one week of controlled dietary intervention, subjects will consume a high fat morning~     meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After~     consumption of the breakfast meal, subjects will be assessed for endothelial function and~     postprandial meal response.~   "
99893|NCT01749839|"~     Past PRP therapy is not sufficient for some part of patients.In this clinical research, The~     integrated application of PRP with extracellurar matrix and some type of stem cell~     technique.~   "
99894|NCT01749826|"~     The PI is interested in learning how the immune system and the inflammation process is~     effected by acute and chronic opioid exposure. Preliminary evidence in animal models show~     that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid~     exposure causes increased inflammatory responses, as measured by local cytokine release at~     the site of injury. Translating these findings to humans will lead to important new~     mechanistic knowledge that may ultimately improve our ability to treat pain.~   "
99895|NCT01749813|"~     This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical~     remission in pediatric and adult patients with Crohn's disease.~   "
100181|NCT01745809|"~     The purpose of this research study is to collect lung tissue and fluid from two groups of~     people: those who have severe asthma, and those who do not. These samples will then be~     tested in a laboratory to identify differences in the lung tissue cells and fluids that may~     exist between these two groups of people.~   "
99901|NCT01749735|"~     The aim of this study is to compare the effect of transcranial direct current stimulation~     and functional upper extremity task training to functional upper extremity task task~     training alone. The functional upper extremity task training takes uses the Armeo Spring~     robotic arm to support the limb while playing functional task games on the computer.~      Specific Aims:~        1. To demonstrate that tDCS combined with upper extremity functional task training in a~          virtual environment is more effective than functional task training in a virtual~          environment with sham tDCS.~        2. To compare cortico-excitatory changes following training with tDCS vs. sham~          stimulation, using paired- and single-pulse transcranial magnetic stimulation as a tool~          to measure cortical excitability.~   "
99902|NCT01749722|"~     To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy~   "
99903|NCT01749709|"~     Clinical study including 60 subjects to investigate the effect of daily music listening on~     stress parameters during the acute phase of stroke and on recovery. 20 subjects listen to~     instrumentala music, 20 listen to music with lyrics and 20 are controls. Outcome measures in~     the acute phase are levels of physiological stress parameters (cortisol, endorphin,~     oxytocin). Outcome measures in the recovery phase are cognitive capabilities and mood~     measured with standard clinical tests. Follow-up time is 6 months.~   "
99904|NCT01749696|"~     The aim of our study is to investigate the alterations in connective tissue of vaginal wall~     in patients with and without pelvic organ prolapse (POP).~   "
99905|NCT01749683|"~     The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to~     study and compare short/long term change of myocardial perfusion abnormality and cardiac~     outcome in diabetic patients after nonfatal MI (heart attack), who are treated with~     different glucose control agents.~   "
99906|NCT01749670|"~     There is accumulating evidence that genetic expression plays a role in autism spectrum~     disorder, but the regulation of such genes is poorly understood. Small RNA particles, called~     microRNA (miRNA), have the ability to alter gene expression. These particles can be packaged~     and released from brain cells into the blood. Changes in miRNA may contribute to the~     patterns observed in autism spectrum disorder.~      The purpose of this study is to identify small RNA particles that regulate gene expression~     in autism spectrum disorder. The goal is to identify miRNA expression patterns which may~     improve our understanding and diagnosis of autism spectrum disorder.~   "
99907|NCT01749657|"~     The lack of high quality evidence to guide conservative care for patients with posterior~     tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous~     orthotic devices are available to avoid a costly and debilitating surgery but no consensus~     on which to use has been made. The current study aims to link biomechanical testing of~     selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12~     weeks.~   "
99908|NCT01749644|"~     Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis~     (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to~     eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin~     which is given every other month.. Inhalation of Tobramycin was proven as an effective~     treatment that improves the respiratory function and reduces the concentration of bacteria~     in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and~     therefore adherence is a major problem. The effect of switching from inhalation treatment to~     inhaler treatment on patient's adherence and quality of life has not been studied.~   "
99909|NCT01749631|"~     The purpose of this study was to record the effectiveness of sevoflurane for intubation in~     Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards~     to the rate of intubation success.~   "
99910|NCT01749618|"~     Rheumatologists treating patients with seronegative arthritis will be randomized to treat~     their patients to a target or to treat their patients under their usual standard of care.~     All physicians will perform an initial chart audit. Following the initial chart audit, all~     physicians in the treat-to-target group will receive accredited educational training. Six~     months after the initial chart audit, all physicians will perform a repeat audit to see if~     patients are assessed more systematically and treated to a target of low disease state.~   "
99911|NCT01749605|"~     Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of~     nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.~   "
99912|NCT01749592|"~     -  As the left and right hemisphere are specialized for different auditory tasks, the~          proposed study aims at demonstrating different consequences of right or left-sided~          deafness for the affected individual.~        -  Furthermore, the question should be answered if auditory deficits and plastic changes~          can be partially reversed by cochlear implantation of the deaf ear.~        -  Multicenter, prospective, open, non-randomized clinical trial with 5 patients with~          right-sided and 5 patients with left-sided sensineural deafness.~        -  Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG~        -  Comparison of pre-operative investigations with 10 healthy subjects (age and gender~          matched control group)~        -  Cochlea implantation~        -  Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization~          Audiometry, PET, EEG, Questionnaires~        -  Trial with medical device~   "
99913|NCT01749579|"~     Sixty patients who refer to the emergency ward and need any painful procedure in the ward~     are randomized into 2 groups. One group is sedated before the procedure using~     propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation.~     The two groups will be compared regarding recovery time and other parameters described~     below.~   "
99928|NCT01749384|"~     This phase I trial studies the side effects of and best dose of tivantinib when given~     together with bevacizumab in treating patients with solid tumors that have spread to other~     areas of the body or cannot be removed by surgery. Tivantinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells.~     Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving~     tivantinib together with bevacizumab may work better in treating tumor cells.~   "
100377|NCT01743261|"~     The aim of this study was to compare the cost/utility ratio of a management model of~     integrated, graded, intensive rehabilitation (GIR) versus usual care (UC) for patients with~     acquired Severe Brain Injury (SBI).~   "
99914|NCT01749566|"~     Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are~     used by a person before they are exposed to HIV in order to decrease his or her chance of~     getting infected. In this study, we will investigate a new PrEP strategy in women using a~     drug called maraviroc, a medicine used in the treatment of HIV infection called a CCR5~     antagonist. We hypothesize that maraviroc could be a particularly good drug for PrEP because~     it achieves high concentrations in the genital tract in women and decreases the number of~     HIV-susceptible cells in the genital tract, and thus could potentially be dosed in more~     favorable ways than the current PrEP drugs.~      In order to further evaluate this PrEP strategy, we plan to measure the amount of maraviroc~     in the blood and genital tract of HIV-negative healthy female volunteers before, during, and~     after they are given maraviroc dosed either in the standard (twice a day) or reduced (once a~     day) dose for 7 days compared with women who are not given maraviroc. We will also study~     immune cells from the blood and genital tract from these women to see if maravoric has an~     effect on these cells that would prevent them from becoming infected with HIV.~   "
99915|NCT01749553|"~     To Determine whether an eight-week posterior shoulder stretch was effective in increasing~     dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a~     group of overhead athletes identified as having tightness of their posterior shoulder~     structures.~   "
99916|NCT01749540|"~     The purpose of this study is to evaluate the effects of ACE-536 in patients with~     beta-thalassemia.~   "
99917|NCT01749527|"~     We hypothesised that in women with stress urinary incontinence, the severity of leakage on a~     24 hour pad test was affected by activity.~   "
99918|NCT01749514|"~     The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with~     low or intermediate-1 risk MDS.~   "
99919|NCT01749501|"~     Those infants who received the muscle relaxation in combination with the vagolytic (reduce~     vagus nerve impulses) and pain medication will have reduced time to successful intubation~     (placement of tube into the lungs), a decrease in the number of attempts, and better~     intubation conditions reported by the practitioner. The objectives of the study include: 1.)~     Does the medication protocol outlined in this study provide optimal intubation conditions?~     (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.)~     Does the addition of a muscle relaxant prior to intubation contribute to less attempts and~     achieving successful intubation as opposed to neonates who do not receive the muscle~     relaxant.~   "
99920|NCT01749488|"~     The main objective of this study is to evaluate the impact of the intervention of a~     dietician on the energy balance accumulated over seven days of intensive care.~      Energy balance is defined as the difference between the target recommended energy and total~     calorie intake actually received.~      This is a randomized-cluster study; participating centers are randomized into experimental~     and control groups.~   "
99921|NCT01749475|"~     Most of the reports on hypnosis in the literature have focused on pain control during minor~     operations. With this study we aimed to evaluate the role of hypnosis on sedation for~     transesophageal echocardiography and compare it with commonly used sedative midazolam.~   "
99922|NCT01749462|"~     The purpose of the investigation is to confirm the ADR development and the contributing~     factors possibly having an impact on the safety under the post-marketing actual use of Oxis~     9 mcg Turbuhaler.~   "
99923|NCT01749449|"~     The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15%~     vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial~     thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%;~     28days) in overweight individuals. We hypothesize that HP will elicit more favorable body~     composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of~     change will be greatest in those consuming HP meals more frequently.~   "
99924|NCT01749436|"~     General anesthesia results in the development of atelectasis in the dependent areas of the~     lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures,~     pneumoperitoneum increases already present atelectasis.~      Several methods have been suggested to reduce the impact of atelectasis during surgery.~     However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are~     available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and~     easy to use tool that as yet to be studied in the intraoperative setting.~      This observational study will aim to clarify the role of lung ultrasound imaging during~     laparoscopic surgery for the diagnostic and monitoring of atelectasis.~      This study is designed to:~        -  Demonstrate a link between the lung ultrasound aeration score, the partial pressure of~          oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the~          oxygenation index.~        -  In the event of intraoperative desaturation, study the impact of positive~          end-expiratory pressure (PEEP) and/or increase of FiO2 on the aeration score.~        -  Study the impact of pain on diaphragmatic function and the aeration score.~      Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes~     associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia~     and changes occurring during the stay in the recovery room.~   "
99925|NCT01749423|"~     This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in~     patients with Chronic Migraine.~   "
99926|NCT01749410|"~     This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA~     in Chronic Migraine patients who have received a minimum of 7 treatment cycles.~   "
99927|NCT01749397|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or~     fallopian tube cancer that has spread to other places in the body. Veliparib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving veliparib together with floxuridine may kill more tumor cells.~   "
99937|NCT01749267|"~     The objective of this study was to analyze the radiographic density of digital subtraction~     radiographs after SMART restoration with partial caries removal in primary molars at 6 and~     12 months.~   "
106328|NCT01665417|"~     This study is designed to compare the efficacy and safety of first-line icotinib treatment~     and first-line chemotherapy followed by maintenance treatment with icotinib.~   "
99929|NCT01749371|"~     A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E~     short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn~     injury and, in the process, decrease the secondary consequences of burn injury, including~     lung injury and impaired wound healing. This may improve the quality of life of the burn~     patient by preventing pathophysiology that may result from oxidative stress and may reduce~     hospital stay. Our research will lay the foundation for the future development of effective,~     safe, and economic therapeutic interventions to treat burn injury-associated metabolic~     abnormalities. Also, it will provide the basis for the development of supplemental~     regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very~     reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a~     simple vitamin that is abundant and approved for clinical use, and b) the subjects will be~     monitored consistently for the minimal increased tendency to bleed.~   "
99930|NCT01749358|"~     This study is about rehabilitation of arm function after a stroke. The investigators are~     testing the dosage of therapy that is needed for meaningful recovery of arm and hand~     function. Dosage of therapy refers to the amount of time (in this case, the total number of~     hours) that a person participates in treatment. The investigators hope to learn how much~     therapy time is needed in order for change to occur in arm and hand function after a person~     has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or~     hand at least 6 months ago.~   "
99931|NCT01749345|"~     This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and~     300 African-American) who will be recruited from two primary care sites to determine how~     social determinants of health impact diabetes outcomes. The first aim is to investigate the~     role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim~     is to investigate the influence of community and neighborhood characteristics on diabetes~     care processes and outcomes. Finally, we will examine the contribution of social~     determinants of health to ethnic differences in diabetes care processes and outcomes.~     Clinical and metabolic measures will be abstracted from the electronic medical records.~     Outcome variables include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of~     life.~   "
99932|NCT01749332|"~     The purpose of this study is to draw blood from vessels near the liver in patients~     undergoing liver surgery. This will be performed in both patients with cancer in order to~     learn more about circulating tumor cells, proteins and DNA mutations in the blood.~      The blood in patients with colorectal cancer with liver metastases will be compared to blood~     taken from patients that do not have cancer that do not have cancer.~      Inclusion of patients with benign pathology will allow for the establishment of normal~     values which currently do not exist. We will then study whether tumor mutations can be used~     to predict recurrence and survival patterns.~   "
99933|NCT01749319|"~     The primary objective of this study is to characterize baclofen pharmacokinetics following~     oral and intravenous administration in patients who are on chronic oral baclofen therapy.~     The secondary objective is to determine the safety profile of an IV baclofen formulation.~      This study is a randomized crossover study with two treatment arms. All subjects will~     receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether~     the oral or intravenous form is given on the first study day will be randomized in a 1:1~     manner.~      The pharmacokinetic and tolerability information gained from this study will support the~     development of further studies to assess the use of IV baclofen to prevent or treat baclofen~     withdrawal syndrome.~   "
99934|NCT01749306|"~     The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment~     of patients with epidermolysis bullosa who have wounds that are not healing.~      It is hypothesized that ABH001 may initiate and continue wound healing in patients with~     epidermolysis bullosa.~   "
99935|NCT01749293|"~     Allogeneic stem cell transplantation is a potentially curative treatment for patients with~     many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of~     relapse). This process requires a suitable donor. The best case scenario involves an Human~     Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always~     available. Donor registries can provide another source for matched unrelated donors, but~     this may take valuable time delaying treatment for the transplant recipient. Donor~     availability remains a significant barrier to the use of allogeneic (from a donor) stem cell~     transplant. This issue disproportionately affects patients of minority backgrounds. Novel~     strategies to improve outcomes using alternative donors are desperately needed.~      Haploidentical transplants are an alternative which provides a readily available donor in~     the form of a partially HLA matched family member. This provides for more potential donors~     and the donors can be selected based on other factors that can play a role in transplant~     success (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques~     have greatly improved success rates with haploidentical transplants although disease relapse~     has remained as issue.~      This trial aims to provide an alternative transplant option for patients with hematologic~     malignancies who require bone marrow transplantation but lack an HLA identical donor. The~     investigational component of this study is the combination of the Fludarabine/ Busulfan/~     Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with~     post-transplant Cyclophosphamide.~   "
99936|NCT01749280|"~     The aorta is the main blood vessel that comes out of the heart and distributes blood to the~     whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as~     it passes through the abdomen. These 'abdominal aortic aneurysms' often occur without~     symptoms and can burst or rupture without warning. This usually leads to death and~     represents the thirteenth commonest cause of death in the United Kingdom. In this study, we~     are looking at a new technique that can look at the aortic aneurysm using magnetic resonance~     imaging; a technique that does not require x-rays or radiation. We have recently shown that,~     using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots'~     of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are~     therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh~     that will invite all patients who are under surveillance because of an aneurysm. We will~     image these patients using this novel technique and see if we can identify which patients~     burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die.~     This will be important to establish as it will potentially lead to a new way of managing~     people that could ultimately save lives. This is particularly timely as national screening~     and surveillance programmes are currently being launched.~   "
99938|NCT01749254|"~     Cardiovascular disease is the leading cause of death in Scotland and the Western World.~     Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic~     plaques are urgently needed to help risk stratification, to identify patients for intensive~     therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug~     interventions. Using positron emission tomography, we have recently shown that sodium~     18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and~     rupture. Here we wish to characterise coronary atherosclerotic plaque using~     128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium~     18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in~     80 patients with stable and unstable coronary artery disease. This has the potential to~     provide an innovative and highly valuable translational model with which to test novel~     therapeutic interventions targeted at reducing atheroma and plaque rupture. This could have~     major implications for the future treatment of cardiovascular disease.~   "
99939|NCT01749241|"~     Inflammation occurs after any type of incisional surgery. This study will evaluate the~     efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative~     inflammation after routine eyelid surgery.~   "
99940|NCT01749228|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy, adult human subjects.~   "
99941|NCT01749215|"~     The goal of this project is to improve the treatment of veterans with co-occurring alcohol~     dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will~     conduct a controlled clinical trial of topiramate for the treatment of these co-occurring~     disorders.~   "
99942|NCT01749202|"~     The purpose of this study is to assess the effect of stearidonic acid when used as a food~     ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in~     men and women.~   "
99943|NCT01749189|"~     This study will investigate the effects of a soy/dairy protein blend on muscle growth and~     strength. In sports nutrition and in aging it is important to have healthy muscles. This can~     be achieved with exercise and nutrition. Consumption of protein following resistance~     exercise can promote healthy muscle growth and help improve strength. Young healthy men will~     be studied during a 12 week resistance exercise training program and be given protein~     supplements every day during the study. The hypothesis is that a blend of soy, whey and~     casein will induce a greater muscle gain and strength increase than the control.~   "
99944|NCT01749176|"~     Randomized controlled trial testing the efficacy of a text messaging intervention in a low~     income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will~     address barriers to participation in health education classes, increasing adherence to~     treatment and medications and improving diabetes self management behaviors and skills. Two~     community clinic organizations that provide services to a large proportion of Latino~     patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms:~     standard diabetes management care (control) only or text messaging and standard care.~     Comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes.~      Intervention: Standard Care and Text Messaging. All participants will receive standard~     diabetes care provided by primary care providers at the clinic. Of the 100 that are~     randomized to the intervention arm will be given instructions on how the text messaging~     component will be addressed throughout the duration of the study.~   "
99945|NCT01749163|"~     Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion~     augment insulin secretion from the pancreas to help maintain glycemic control. Studies in~     vitro and in vivo have shown that these incretin hormones also have functional effects in~     other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate~     insulin secretion in a glucose-dependent manner, however the glucose-dependency of their~     extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp~     methodology during euglycemic and hyperglycemic conditions we will test the hypothesis that~     extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.~   "
99946|NCT01749150|"~     This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability,~     pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with~     Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian~     origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus~     ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys~     180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment~     duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated~     cirrhosis.~   "
99947|NCT01749137|"~     The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight~     loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and~     ambulatory blood pressure in obese patients. The study is designed to evaluate the efficacy~     and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be~     administered subcutaneously in a blinded fashion.~   "
99948|NCT01749124|"~     This is a pilot study for a novel, automated telephone system called My Coach Connect. The~     purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool~     while engaging clients and providers in discussion groups and surveys to better understand~     how this tool impacts the care provided and their overall experience in healthcare. Clients~     will use this tool to leave voice messages and survey answers which their providers will~     have access to by logging in to a secure website. Providers will also be able to indicate~     using the website whether they found a particular narrative helpful or not. Providers will~     have access to audio recordings of the voice responses, transcribed text of the responses,~     as well as word clouds generated from the text. Word clouds are a method of displaying the~     content of text such that words that are used more frequently are displayed in a larger size~     than words used less frequently. Clients will call in to the system approximately twice a~     week for a period of four months.~   "
99949|NCT01749111|"~     The purpose of this study is to determine whether cyclophosphamide post bone marrow~     transplant increases the rate of patients alive, in remission and without immunosuppression,~     one year after transplant, when compared with the combination of methotrexate and~     calcineurin inhibitor~   "
99952|NCT01749072|"~     In the National Comprehensive Cancer Network (NCCN) guideline for NSCLC, epidermal growth~     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is recommended as the third-line~     treatment for EGFR gene mutation negative NSCLC patients who failed to the first-line~     platinum doublet chemotherapy [i.e. paclitaxel-carboplatin (PC) or gemcitabine-cisplatin~     (GP)] and the second-line chemotherapy with docetaxel or pemetrexed. But as we know, if~     patients had no EGFR gene mutation, EGFR-TKI treatment is not effective. The overall~     survival is short and the objective response rate is low. As for EGFR gene wild type~     patients with good performance status, besides EGFR-TKI treatment, other first generation~     cytotoxic drugs i.e. vinorelbine or ifosfamide maybe an alternative treatment. So the~     purpose of this clinical trial is to compare the effectiveness and safety of~     vinorelbine-ifosfamide with gefitinib in advanced or metastatic EGFR gene mutation negative~     NSCLC patients.~   "
99953|NCT01749059|"~     The purpose of this study is to evaluate the impact of implementing a universal pulse~     oximeter screening as a way to detect critical congenital heart disease in otherwise~     well-appearing newborns.~   "
99954|NCT01749046|"~     The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is~     effictive and safe in patients with epilepsy with partial seizures~   "
99955|NCT01749033|"~     A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under~     general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It~     is similar to an endotracheal tube (a breathing tube) but is less invasive. It is also~     placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the~     patient is not adequately ventilating. Unfortunately, an LMA may lead to complications~     similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous~     studies have examined several variables that may affect how often complications occur; these~     variables include giving anti-inflammatory medications and inflating the LMA to different~     pressures (the working end of the LMA, which rests in the patient's throat, has a cuff~     that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE~     on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3~     placement techniques - the traditional placement technique, a slightly different traditional~     placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of~     this study is that a new LMA insertion technique will have no difference in postoperative~     pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.~   "
99956|NCT01749020|"~     The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on~     insulin sensitivity in normal weight and overweight adults.~   "
99957|NCT01749007|"~     The purpose of this project is to gather pilot data related to exploring relationships~     between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or~     behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency~     Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to~     Veterans with HIV/AIDS.~   "
99958|NCT01748994|"~     The body shape of obese women varies between having the majority of fat either above the~     waist (apple shape) or below the waist (pear shape). The study will investigate what~     restricts: apple-shaped women from being pear-shaped at the cellular level. Since pear~     shaped women tend to have better health, this study will open the door to future research in~     regulating body shape and thus improving health.~   "
99959|NCT01748981|"~     The purpose of the study is to investigate the change in pulmonary function and exercise~     capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect~     of training on aerobic capacity, muscular strength, morbidity and survival. Physical~     activity level by accelerometers, body composition by DXA and quality of life will also be~     reported.~   "
99960|NCT01748968|"~     The purpose of this project is to gather pilot data related to risk factors associated with~     suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency~     Syndrome (AIDS) and to develop an educational and interventional tool and instructional~     guide that can be utilized by local and national providers to increase understanding~     regarding suicide risk assessment. There are no hypotheses associated with this qualitative~     pilot study.~   "
99961|NCT01748955|"~     This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of~     two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward~     processing in depressed patients who have attempted suicide or are currently experiencing~     suicidal thoughts.~   "
99962|NCT01748942|"~     This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry~     mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain~     and dry mouth caused by surgery.~   "
99963|NCT01748929|"~     Women of reproductive age are considered a high-risk group for worm infections by the World~     Health Organization. Maternal infection and anemia contribute to infant malnutrition by~     affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no~     study has investigated the health benefits of postpartum deworming to infants or mothers. A~     randomized controlled trial will be conducted in Peru to investigate the effectiveness of~     integrating deworming into routine postpartum care. The primary measure of effect will be~     infant weight gain between birth and six months of age. Other infant and maternal health~     indicators will also be ascertained.~   "
99964|NCT01748916|"~     The goal of this study is to determine if papaya fruits are an exceptionally good food~     source for carotenoids in humans, particularly when compared more common carotenoid sources~     like carrots and tomatoes. This objective will be accomplished by quantitation of the~     immediate post-prandial plasma concentrations of parent carotenoids and vitamin A~     metabolites from subjects who consumed a meal containing fresh papaya, tomato, and carrot.~   "
99965|NCT01748903|"~     The purpose of this prospective registry is to collect real world, post-marketing data on~     the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the~     embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients~     (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with~     intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A~     post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical~     endpoints will be performed.~   "
106791|NCT01659112|"~     The purpose of the study is to determine the effects of the addition of core stabilization~     exercises to a traditional upper extremity rehabilitation program in upper extremity~     injuries.~   "
99966|NCT01748890|"~     Prostate cancer is the most common cancer and the second-leading cause of cancer death~     amongst men in the United States. Sonoelastography is an imaging technology predicated on~     reproducible differences in the backscattered ultrasound signal produced by compression of~     tissues of varying stiffness. It permits measurement of the elastic properties of tissue.~     These measurements can be transposed onto conventional anatomic ultrasound images, producing~     a colorized overlay that allows direct visualization of the anatomic distribution of tissue~     stiffness. In this study, we aim to determine whether prostate biopsies planned with~     sonoelastographic guidance would be more likely than random prostate biopsies to intersect~     with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies~     planned with sonoelastographic guidance would be more likely than random prostate biopsies~     to yield histopathology representative of the final Gleason Score obtained at pathologic~     assessment of the resected prostate.~   "
99967|NCT01748877|"~     The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is~     effective in reducing pain levels in patients with post-herpetic neuralgia.~   "
99968|NCT01748604|"~     The purpose of this multicenter randomised controlled study is to determine whether manual~     lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression~     (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy~     (DLT) in patients with lymphedema~   "
99969|NCT01748591|"~     A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.~   "
99970|NCT01748578|"~     This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular~     administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of~     EBI-005 will be assessed.~   "
99971|NCT01748565|"~     The purpose of this study is to identify biological markers that might predict premature~     infants who are at a higher risk for developing BPD, and to correlate the presence of these~     markers with infant symptoms and lung function in the first year after discharge from the~     hospital.~   "
99972|NCT01748552|"~     The aim of this trial is to evaluate the safety of the study drug in healthy participants~     and participants with diabetes. It will investigate how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of it. Information about any side~     effects that may occur will also be collected.~      The study consists of two parts. Part A will study healthy participants in up to 3 dosing~     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3~     dosing periods over approximately 6 weeks.~   "
99973|NCT01748539|"~     This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with~     moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled,~     parallel group study. Pharmacokinetics of KHK4827 will also be assessed.~   "
99974|NCT01748526|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of~     canagliflozin (JNJ-28431754) in healthy Indian volunteers.~   "
99975|NCT01748513|"~     Preoperative venous return stability and euvolemia is essential in management of morbidly~     obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on~     preoperative management, are rare and not in consensus.The aim of this study was to evaluate~     preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on~     hemodynamics, stroke volume and level of venous return to the heart.~   "
99976|NCT01748500|"~     The main objectives of this trial are:~        1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in~          men with metastatic CRPC who have not received prior chemotherapy.~        2. To evaluate archival prostate cancer tissue of men included in the clinical trial for~          evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.~        3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.~   "
99977|NCT01748487|"~     The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone~     intravitreal implant) 0.7 mg administered immediately after phacoemulsification and~     intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of~     post-surgical macular edema (ME).~      Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of~     cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on~     the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months~     (visit 4).~      BCVA, IOP and SD-OCT will be performed at each visit.~   "
99978|NCT01748474|"~     In a randomized, sham-controlled trial the investigators will test whether supplemental~     oxygen given during cardiopulmonary exercise testing will improve exercise performance and~     physiological parameters in patients with pulmonary arterial or chronic thromboembolic~     pulmonary hypertension.~   "
99979|NCT01748461|"~     The purpose of the present study is to evaluate the short-term and long-term effects of a~     cycle ergometer program on physical activity and physical fitness in elderly (65+).~     Therefore, physical activity, physical fitness and functionality are measured at baseline,~     after 10 weeks (after the intervention period), after 6 months and after 1 year.~      Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer~     program) will also be evaluated. What is the best (coaching) approach for long-term~     adherence (physical activity)?~   "
99980|NCT01748448|"~     To assess whether vitamin D supplementation after surgery of a first cutaneous malignant~     melanoma protects against relapse of the disease.~   "
99981|NCT01748435|"~     Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of~     patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit~     protheses and mobilise. Current treatment options are limited and existing painkillers have~     significant side effects. Nevertheless there is some evidence that pre-emptive analgesia~     (pain relief provided prior to the surgery) has additional benefits after the surgery~     (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is~     applied directly onto the skin. It works by desensitising to pain receptors in the skin~     (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in~     other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for~     pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot,~     randomised controlled study of 30 patients undergoing lower limb amputation who will have~     Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks~     post-operatively with regular assessment of pain scores, quality of life and wound healing.~   "
99982|NCT01748422|"~     Arteriovenous fistulae are artificial connections between the artery and vein in the arm~     which allow needles to be inserted for haemodialysising patients wit kidney failure.~     Occasionally severe debilitating pain can arise from these fistulae for which no cause can~     be found. Such pain can be very difficult to treat. Many commonly used used painkillers are~     known to cause significant side effects in patients with renal failure (drowsiness,~     confusion etc.~      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied~     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.~     It therefore should not have the systemic side effects of other drugs. It has been~     demonstrated to be beneficial in other painful conditions for example post-shingles pain and~     nerve pain from HIV. It has never been used for critical ischaemia before.~      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal~     failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful~     AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change~     in their pain scores.~   "
99983|NCT01748409|"~     The aim of the study is to evaluate the autonomic failure in Parkinson's disease by~     clinical, electrophysiological and neuropathological examination.~   "
99984|NCT01748396|"~     Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and~     mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and~     arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently~     identified phosphaturic hormone that has been reported to be associated with the development~     of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.~      While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased~     FGF-23 levels have been reported with vitamin D administration. The purpose of this study~     was to investigate the effect of calcium carbonate when used in conjunction with calcitriol~     on FGF-23.~   "
99985|NCT01748383|"~     The purpose of this study is to test the hypothesis that the intracoronary transplantation~     of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular~     contractile function and will reduce the combined end points after the primary STEMI~     (mortality, recurrent myocardial infarction, angina, heart failure, stroke).~   "
99986|NCT01748370|"~     Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of~     younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as~     well as with increased mortality. There is evidence showing a relationship of TT with~     vitamin D in men. We aim at evaluating the effect of vitamin D supplementation on TT and~     metabolic parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D~     weekly in a 12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0~     ng/ml and 25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT~     ≥3.0 ng/ml and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe~     therapeutic approach improving TT levels as well as metabolic parameters in hypogonadal men.~     Further the effects of vitamin D on androgens will be evaluated in eugonadal men.~   "
99987|NCT01748357|"~     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.~     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis~     require advanced and expensive diagnostic methods that restrict their availability in~     resource limited countries where the burden of tuberculosis is highest. The development of~     rapid point of care diagnostics is required.~      Published data confirm that trained African giant-pouched rats are able to identify M.~     tuberculosis cultures through olfactory recognition. A first trial using an electronic nose~     reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in~     June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the~     recognition of tuberculosis remains unknown.~      This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a~     potential for further development and fine tuning. A technical prototypic device of Siemens~     is used for pattern detection.~      The study is comparing 3 groups of patients:~        -  patients with confirmed active pulmonary tuberculosis (n=20)~        -  patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial~          carcinoma) (n=20)~        -  healthy volunteers that do not work in the hospital or visit the hospital regularly~          Detailed data for all study subjects will be collected for this trial in order to~          eliminate confounding factors. Furthermore, detailed data of the surroundings of the~          patient, the surroundings of the technical device and of the operator will be captured.~      Hypothesis:~      The pattern of exhaled volatile organic compounds allows the detection of pulmonary~     tuberculosis~   "
99988|NCT01748344|"~     The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic~     rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled~     conditions.~   "
99989|NCT01748331|"~     The purpose of this study is to determine the effect of fluid restriction and the~     neurohormonal mechanisms in the development of hyponatremia in patients with congestive~     heart failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a~     larger increase in plasma sodium than standard treatment in patients with decompensated~     heart failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal~     change is greater in patients treated with strict fluid restriction versus standard~     treatment.~   "
99990|NCT01748318|"~     In a time of emerging bacteria that are resistant to antibiotics, honey offers an~     alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics.~     We will be evaluating the effectiveness of a locally produced New Mexico Honey against the~     standard of care Bactrim antibiotic on Community Acquired MRSA.~   "
99991|NCT01748305|"~     Patients with newly diagnosed gestational diabetes will be recruited. The control group with~     get routine diet and exercise counseling. The intervention group will be instructed to get~     moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with~     supervision in order to be instructed how hard to work. All participants will keep an~     exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is~     glucose control, specifically the need for medication in treatment of their diabetes. The~     hypothesis is that moderate or greater intensity exercise will better control glucose and~     lead to less need for medication management.~   "
100887|NCT01736618|"~     The purpose of the S-ICD Post Approval Study is to document long term safety and~     effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and~     Q-TRAK electrode in a commercial clinical setting.~   "
99992|NCT01748292|"~     TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be~     randomized 1:2 to monthly (control arm) or treat and extend protocol (comparator arm)~     respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections~     (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN)~     treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients~     with wet age-related macular degeneration (AMD). Subjects treated in a treat and extend~     protocol receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week~     8, if a subject has achieved a dry macula; signs of active exudation have resolved will~     begin a Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry~     macular is maintained). At the beginning of the 104-week endpoint subjects initially~     randomized to the TREX cohort will transition to PRN re-treatment when there is no exudative~     disease activity at the 12-week interval.~   "
99993|NCT01748279|"~     Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients~     possibly as a result of an anti-inflammatory effect.~      Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of~     patients with COPD.~      A controlled, parallel group study to compare the effects of Atorvastatin in comparison to~     placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD~     in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD,~     serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial~     lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB~     specimens will be processed for histology, immunohistochemistry and microarray analysis.~   "
99994|NCT01748266|"~     Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB)~     have been thought to be at the origin of organ dysfunction. Though, few studies correlated~     microvascular alterations with outcome. Investigators aimed at firstly describing~     microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS~     parameters with intensive care length of stay and organ dysfunction.~   "
99995|NCT01748253|"~     Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to~     hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive~     effect of long-acting ARB-CCB tablet between morning administration and bedtime~     administration.~   "
99996|NCT01748240|"~     Azacytidine (AZA) is the current standard of care for frontline patient treated with~     high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will~     never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in~     MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this~     agents have shown more responses based on phase I/II data. In the present study, we will use~     the combination of these two drugs to try to create a synergetic effect and generate a~     response for patients who experienced treatment failure after AZA.~      All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of~     28 days. Study Design~   "
99997|NCT01748227|"~     The overall purpose of this pilot study is to conduct a formative evaluation of~     (veteran)peer delivery of a chronic pain self-management program to veterans with chronic~     musculoskeletal pain.~      Our specific aims are as follows:~      Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran~     peers to implement a self-management program for chronic pain.~      Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management~     program.~      Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the~     results, and plan next steps.~   "
99998|NCT01748214|"~     Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory~     support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal~     cannula: >1 L/min flow - HFNC). While there have been small descriptive studies of noise~     exposure in infants on NCPAP, there have been no comparative trials done comparing noise~     exposure in infants undergoing both NCPAP and HFNC.~      Objective: Using a cross-over model determine noise exposure levels in infants exposed to~     similar levels of respiratory support provided by NCPAP and HFNC.~   "
99999|NCT01748201|"~     Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that~     affects about one in every ten thousand people. Hemarthrosis, which you can begin in~     childhood, promptly leads to degenerative changes of the articular cartilage which culminate~     in deformity and degenerative changes early, known as hemophilic arthropathy, which is the~     most common complication of hemophilia. Aside administration of clotting factor, treatment~     should address the degenerative changes already present in patients joints. Our objective is~     to evaluate the effectiveness of articular washing followed by infiltration with~     corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as~     the previous level of hemophilia patients, in relation to pain relief, and improved function~     and quality of life.~   "
100000|NCT01748188|"~     The purpose of this study is to determine whether dexketoprofen administered by~     phonophoresis or iontophoresis is more effective in the treatment of subacromial syndrome~     that the conventional therapy with ultrasounds.~   "
100001|NCT01748175|"~     The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical~     centers that encompass a multidisciplinary partnerships between asthma clinician-scientists~     and scientists with expertise in immunology, pulmonary physiology, molecular genetics,~     molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly~     recruit volunteers with asthma for an observational longitudinal follow-up study. However,~     centers will also conduct specific mechanistic research projects at each participating~     institution. The University of Pittsburgh's SARP III study will determine the molecular and~     clinical stability of asthma phenotypes over time.~   "
100002|NCT01748162|"~     Presently children who experience recurring croup symptoms receive a variety of treatments.~     This is because it is not clear which treatments may be best. Some children are given~     inhaled steroids (similar to what children with asthma use). Others are carefully watched~     and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and~     should episodes of croup recur they are treated with a short course of oral steroids. The~     purpose of our study is to compare two safe and clinically appropriate methods for treating~     recurrent croup, daily inhaled steroids versus observation with oral steroids on an as~     needed basis, to see if either is useful in preventing future episodes of croup.~   "
100005|NCT01748123|"~     -  Clinical equipoise exists with respect to the important question, What is the best~          initial diuretic for the treatment of Hypertension? A pragmatic comparative~          effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide could~          help inform decision making for this common problem.~        -  The investigators aim to harness both the power of bioinformatics (using web-based~          data-capture and electronic health records) and of online media (through collaboration)~          in order to facilitate such a CER in usual-care settings. This process may also~          provide a foundation for testing a wealth of important clinical questions which~          commonly arise in the delivery of contemporary healthcare and would otherwise be left~          unanswered.~        -  To this end the investigators are developing a website, EBMtrialcentral, where eligible~          physicians can go online and join their collaborative network. Physicians can then~          enroll eligible patients in this study. These will include under-served urban patients.~          Clinical information will be entered online (using a secure database housed at Johns~          Hopkins), patient consent will be obtained electronically and treatment recommendations~          will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral~          Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone~          over 8 weeks and compare their effects on BP measured with a 24 hour monitor.~        -  The investigators' primary hypothesis is that non-blinded, random, parallel allocation~          of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a~          clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP~          from baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4~          weeks) in newly hypertensive patients followed in a usual-care clinic setting over 8~          weeks. They will also analyze differences in side-effects or safety (serum~          electrolytes) between these two medications.~   "
100006|NCT01748110|"~     The goal of the study is to assess the impact of a health intervention, involving both diet~     and exercise modification, on outcomes following radical prostatectomy for the treatment of~     clinically localized prostate cancer. The specific urological outcomes expected to be~     improved are accelerated and/or improved recovery of erectile function (EF), as well as~     urinary continence, both very commonly affected by this surgery. Furthermore, as~     demonstrated by changes in responses to various questionnaires, an improvement in overall~     health-related quality of life is expected. Finally, an improvement in patients~     participating in the intervention groups in physical parameters, including body mass index~     (BMI), blood pressure (BP), and metabolic parameters, including serum glucose and~     cholesterol levels, is expected.~   "
100007|NCT01748097|"~     The investigators use bicarbonate injected to an intravenous line and the changes in the~     exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding~     tissue~   "
100008|NCT01748084|"~     The purpose of this study is to determine whether rituximab is effective in the treatment of~     articular symptoms that occur in systemic sclerosis related polyarthritis~   "
100009|NCT01748071|"~     Purpose: This study aimed to find a quick and timely way to investigate the individual~     variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries.~     Methods: 120 female patients receiving elective surgery under general anesthesia were~     recruited into this study. At the time of routine intravenous anesthetic induction we~     observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend~     index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular~     system.~   "
100010|NCT01748058|"~     The aim of this study is to evaluate the efficacy and feasibility of active video gaming~     with regard to the promotion of physical activity and motor learning in children with~     cancer. Experienced fatigue, body mass index and the development of metabolic risk factors~     during treatment are also examined.~   "
100011|NCT01748045|"~     The aim of this study is to determine if inhaled nitric oxide will improve short and long~     term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36~     weeks and who require breathing support with high flow nasal cannula, nasal continuous~     positive airway pressure, or nasal intermittent positive pressure will be randomized to~     receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol~     until all respiratory support has been discontinued. Infants will be followed to evaluate~     safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.~   "
100012|NCT01748032|"~     The purpose of this study is to examine the effects of the alternative uses training (AUT)~     and word association training (WAT) on cognitive functions and mood symptoms in late-life~     depression (LLD).~      The hypotheses are:~        1. post-training cognitive performance will be superior to pre-training cognitive~          performance~        2. post-training depressive symptomatology will be less severe as compared with~          pre-training clinical severity and~        3. AUT group will show better post-training cognitive performance and improved mood~          symptoms when compared with the WAT group.~   "
100013|NCT01748019|"~     ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex,~     inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and~     an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan~     and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor~     activity has been also noted in platinum resistant ovarian cell xenografts and in~     topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and~     the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical~     trials.~   "
100014|NCT01748006|"~     The relationship between the activation of the vasopressin system and central hemodynamics~     in heart failure (including right and left heart filling pressures and cardiac output) is~     not clear. The investigators intend to examine the correlation between levels of copeptin~     and vasopressin and the central hemodynamic system in patients with advanced (class III or~     IV) heart failure. The investigators also aim to examine the relationship of selected~     cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in~     patients with decompensated heart failure.~      The study population will consist of 30 patients admitted to the Department of Cardiology at~     Copenhagen University Hospital. Only patients for whom the attending cardiologist has~     already decided upon right heart catheterization for clinical/treatment reasons will be~     recruited for the study.~   "
100015|NCT01747993|"~     Catheter-associated urinary infections are the most common hospital-acquired infections and~     can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the~     failure of early catheter removal has been studied in elderly women hospitalized for an~     acute condition and experiencing acute urinary retention: 448 women 75-year old or more~     without an anatomical or neurological cause of urinary retention will be randomized to a 6~     days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the~     third dose of tamsulosin and the need to replace another catheter within 72 hours will~     define a failed attempt.~   "
100921|NCT01736176|"~     The primary objective of this study is to evaluate change in non-motor symptoms from~     baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.~   "
100016|NCT01747980|"~     Absorption of therapeutic proteins taken orally has remained the major hurdle for treatment~     in humans. The proteins are generally degraded by enzymes in the stomach and intestine and~     the intestine lining that prevents absorption into the circulation. Administration of~     PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier~     vehicle, may help overcome many of these hurdles. The plant cell wall protects the protein~     from degradation in its transport through the upper GI and allows release in the lower~     intestine. Studies in animals have shown that prGCD delivered in this way can be found in~     the blood stream in an active form.~   "
100017|NCT01747967|"~     There is currently no imaging technique allowing to directly visualize and measure~     pancreatic beta-cell mass. Consequently, the best parameter to estimate this mass is the~     insulin (and its C-peptide byproduct) that residual beta cells are able to produce. This~     insulin secretion is measured during a meal test, before and at different times after~     drinking a standardized quantity of nutrients. However, this test is cumbersome (lasting 3~     h, with blood samples taken every 30 minutes) and it holds poor sensitivity, probably~     insufficient to detect very few residual beta cells. Nevertheless, these few residual cells~     can improve glycemic control and can be instrumental for the clinical efficacy of immune~     and/or regenerative therapies.~      We hypothesize that residual beta cells may not only represent the remaining insulin~     secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T~     lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may~     thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may~     therefore provide simple and sensitive immune surrogate markers of residual insulin~     secretion. Other surrogate markers may be obtained by measuring urinary C peptide or~     residual secretion of the counter-regulatory hormone glucagon.~      The main objectives of this study are:~        1. To evaluate the correlation between beta-cell-reactive T-cell responses and residual~          insulin secretion.~        2. To evaluate the correlation between the residual insulin secretion measured by serum C~          peptide and by urinary C peptide.~        3. To evaluate the correlation between the residual insulin and glucagon secretion.~   "
100018|NCT01747954|"~     The hypothesis of this study is that respiratory physiotherapy can promote improvement in~     respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is~     more effective in improving respiratory mechanics in childrens and does not alter the~     hemodynamic proved safe~   "
100019|NCT01747941|"~     The study is designed to test safety tolerability and PK of single oral ascending doses of~     PF-06305591,~   "
100020|NCT01747928|"~     Usability testing of the dual-chambered syringe in conjunction with the proposed patient~     instructions for use.~   "
100021|NCT01747915|"~     The study is designed to evaluate the safety, tolerability and efficacy of two doses of~     pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized~     Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of~     pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC~     seizure frequency and that pregabalin will be safe and well tolerated.~   "
100022|NCT01747902|"~     The long head of biceps brachii tendon has been known to be a pain generator and a common~     cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps~     tenotomy and tenodesis have been shown to produce comparable results, but there is no~     consensus to date due to a lack of level I evidence. The aim of this prospective,~     randomized, clinical trial is to compare subjective patient-reported outcomes and objective~     clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the~     long head of the biceps brachii.~   "
100023|NCT01747889|"~     This study is designed to compare the Thopaz chest tube drainage system to the traditional~     collection chamber system. The Thopaz system is already in clinical use in the United States~     and throughout the world. As such, this study is not evaluating safety or efficacy of this~     system both of which have already been demonstrated. This study's primary aim is to~     determine whether the use of a digital chest drainage system compared with a traditional~     system affects duration of chest drainage and length of hospital stay.~      Furthermore, we aim to determine whether the use of a digital chest drainage system compared~     with a traditional system increases the total distance of ambulation in the first 48 hours~     after thoracic surgery and affects overall patient satisfaction in the peri-operative~     period.~      Finally, we want to determine whether the aforementioned outcomes relative to the chest tube~     drainage systems differ in different parts of the world.~   "
100024|NCT01747876|"~     LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo~     activity in both tumor models.~      The primary purpose of this study is to determine the maximum tolerated dose (MTD) and/or~     recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose~     to be used in future studies. This study will also assess the safety, tolerability, PK and~     preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.~   "
100025|NCT01747863|"~     A multicenter observational pilot study will be conducted to determine the natural history~     of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who~     are not qualified for therapeutic hypothermia. The intervention includes: neurologic~     examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge~     home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at~     before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary~     outcome is the percentage of mild NE infants with evidence of brain injury defined by the~     presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the~     neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological~     exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at~     discharge home, death and long-term outcome.~   "
100077|NCT01747278|"~     Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis~     carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD)~     treated with high-dose glucocorticoids and immunosuppressive agents.~      Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12~     weeks.~   "
100078|NCT01747252|"~     This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC)~     containing resveratrol compared with a reference. RGC will be administered as single oral~     dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total~     conjugates will be analyzed.~   "
100026|NCT01747850|"~     The purpose of this study is assess Sativex as a treatment for Cannabis dependence.~     Initially a pilot study will be conducted in five subjects seeking treatment for cannabis~     dependence to ensure that our planned self-titration regimen is appropriate using Sativex.~     This phase will be open label, with no placebo control. Then, there will be a twelve-week,~     double-blind, placebo-controlled study in male and female subjects seeking treatment for~     cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy~     (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined~     Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects~     will have to come daily to the centre to assess usage of medication. Following the~     medication phase, participants will have a follow-up weekly for another four weeks and then~     monthly until the 6 month follow up visit after the target quit date. The investigators are~     planning to enroll 45 subjects over the two-year period.~   "
100027|NCT01747837|"~     The objective of this trial is to determine the efficacy and safety of adjunctive~     catheter-based renal sympathetic denervation (RSDN) in the primary prevention of ICD therapy~     in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD~     for either i) secondary prevention, or ii) primary prevention + inducible VT by programmed~     ventricular stimulation at the time of ICD implantation. These patients will be randomized~     to ICD alone or ICD + RSDN.~   "
100028|NCT01747824|"~     The purpose of this project is to determine the levels of stress biomarkers associated with~     severe pain, agitation from intoxication or psychosis, and excited delirium at various~     levels of the disease in order to compare them to pre-clinical models of law enforcement~     encounters. We hypothesize that the serum catecholamines and markers of metabolic acidosis~     will worsen with the duration and severity of agitation among agitated patients and will not~     worsen among patients with severe pain who are not agitated.~      Specific Aims~        -  To assess the prevalence of patients undergoing treatment for agitation from any cause~          requiring restraint or sedation.~        -  To assess the prevalence of excited delirium in the emergency department.~        -  To determine the difference in serum total catecholamines, serum dopamine, serum~          epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial~          pressure, mortality, and disposition among patients with agitation requiring restraint,~          including excited delirium and patients with severe pain from extremity fractures.~        -  To describe changes in stress biomarkers among patients with changing levels of~          agitation as determined by the Altered Mental Status scale.~   "
100029|NCT01747811|"~     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury~     in our society. Patients with post-concussion syndrome have been shown to have deficits on~     tests of short term memory, divided attention, multi-tasking, information processing speed,~     and reaction time, as well as alteration in mood and emotional functioning. Many patients~     have other vague complaints including fatigue, dizziness, irritability, sleep disturbances,~     and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in~     patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with~     mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer~     outcome, while resolution of the sleep disturbance is associated with improvement in~     cognitive functioning.~      Despite recent evidence of the correlation between sleep quality and recovery from traumatic~     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,~     there have been virtually no direct studies of the causal effects of sleep on recovery~     following mTBI. However, it is quite likely that sleep plays a critical role in recovery~     following brain injury.~      A particularly promising non-pharmacologic approach that shows potential in~     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright~     light therapy. For the proposed investigation, we hypothesize that bright light therapy may~     be helpful in improving the sleep of patients with a recent history of mTBI and may also~     have other mood elevating effects, both of which should promote positive treatment outcome~     in these individuals. Bright light therapy may increase the likelihood that they will~     recover more quickly, benefit more extensively from other forms of therapy, and build~     emotional and cognitive resilience.~   "
100030|NCT01747798|"~     This pilot clinical trial studies auranofin in treating patients with epithelial ovarian,~     primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin,~     may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube~     cancer.~   "
100031|NCT01747785|"~     This study is being done to study how well the heart contracts and relaxes during exercise.~     In addition to traditional measures of heart function, we will use a new computer program~     that may improve understanding of why people feel shortness of breath or fatigue.~   "
100032|NCT01747772|"~     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate~     quantitative measurements that can be used to stage liver fibrosis in patients with chronic~     liver disease.~        1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver~          disease who will undergo nonfocal liver biopsy as part of their routine clinical care.~        2. To assess the sensitivity and specificity of sonoelastography for the detection and~          staging of liver fibrosis~   "
100033|NCT01747759|"~     The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted~     education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there~     is lack of validated booklet containing evidence based informations.~      Our aim is to assess the impact of an evidence based education pre-operative booklet on~     patient's knowledge and beliefs. The secondary objectives are to assess the impact of the~     booklet on patient's satisfaction on the information received, the length of stay in~     orthopedic surgery and the transfer rate to rehabilitation wards.~      To show a difference of 2 points on the knowledge score (range 0-10) between the two groups,~     with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations~     will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge~     and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative~     data will be compared between groups by the Kruskal-Wallis and qualitative parameters via~     Fisher exact test.~      The study protocol was approved by the local Ethic Committee.~   "
100034|NCT01747746|"~     The purpose of this study is to determine that a new drug called Rivaroxaban® is effective~     in preventing patients from forming clots after their heart rhythm has been reset by the~     cardiologist with an electrical device.~   "
100035|NCT01747733|"~     Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic~     retrograde cholangiopancreatography). However, assessment of the level of sedation during~     these procedures is not investigated in detail.~      The purpose of this study is to compare different sedation scales and bispectral index~     during sedation in endoscopic procedures in order to find the best suited assessment method~     for sedation under these conditions.~   "
100036|NCT01747720|"~     There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized~     controlled trials would provide definitive evidence about this effect. However, trials with~     breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has~     been advocated to accelerate progress in the identification of interventions that could~     prevent breast cancer. Mammographic breast density is one of the strongest breast cancer~     risk indicators and is already used as a surrogate outcome in several breast cancer~     prevention trials. The aim of this double-blind randomized controlled trial is to determine~     whether daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period~     of 1 year reduces breast density in premenopausal women compared to placebo. A total of 376~     women (94 per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces~     breast density would provide strong support for the idea that vitamin D can be a safe and~     inexpensive approach for the prevention of breast cancer.~   "
100037|NCT01747707|"~     The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with~     the PFS being around 6 months and overall survival time being 13 months in Japanese and~     Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would~     further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil).~     This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel,~     cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and~     gastroesophageal junction cancer.~   "
100038|NCT01747694|"~     COPD patients often suffer from dyspnea and exercise intolerance which lower their quality~     of life.The aim of this proposed study is to examine the effectiveness of multi-respiratory~     muscle training on respiratory function of COPD patients.~   "
100039|NCT01747681|"~     Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee~     arthroscopies focal chondral or osteochondral defects were found in 19% of the patients~     (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute~     traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral~     bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an~     angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the~     bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or~     hyaline-like cartilage. The microfracture technique causes little damage to the subchondral~     bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The~     quality of the repair tissue after these bone marrow stimulating techniques depends on~     various factors including the species and age of the individual, the size and localization~     of the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and~     the postoperative rehabilitation protocol. Microfracture has been used in small traumatic~     defects in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic~     lesions in older patients (Miller 2004, Steadman 2007). The purpose of the present study was~     to investigate the long-term clinical outcome 10 to 14 years after microfracture of~     articular cartilage defects in the knee and possible predictors of good and poor outcomes.~   "
100040|NCT01747668|"~     To investigate the impact of nutrient supplementation during lactation on levels in breast~     milk.~   "
100041|NCT01747655|"~     Patients with advanced Parkinson's Disease experience a range in the severity of their motor~     fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate~     the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced~     stage of the disease whose motor fluctuations have become troublesome and complicate~     management with oral therapy. The aim of this post-marketing observational study is to~     assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's~     Disease participants characterised by either 2-4 hours of off time or 2 hours of~     non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease~     Rating Scale Total Score in the best on state of at least 40 points at baseline.~   "
100042|NCT01747642|"~     Oncoxin in combination with Surafenib is safe and results in improved survival in patients~     with hepatocellular carcinoma (HCC)~   "
100043|NCT01747629|"~     The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax®~     versus placebo in subjects with persistent asthma.~   "
100044|NCT01747616|"~     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the~     elderly population. One mainstay of therapy for patients suffering from DES is the use of~     topically administered lubricants. However, despite many efforts, no ideal formulation has~     yet been found.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with~     favourable biological properties such as high biocompatibility and low toxicity.~     Additionally, the new formulation comprises N-acetylcysteine, which has been used in~     ophthalmology because of its mucolytic properties for several years. Based on theoretical~     considerations, one can hypothesize that the new chitosan derivative may show an increased~     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in~     reducing the symptoms associated with DES. We have recently shown in a phase I trial that~     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young~     healthy subjects.~      However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine~     in subjects wearing contact lenses. This is of special interest because the tear film is~     critical to successful contact lens wear. Disturbances of the quantity or quality of the~     tear film results in intolerance of contact lens wear and possible damage to the ocular~     surface. This trial seeks to investigate the local tolerability and possible ocular~     discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .~   "
100079|NCT01747239|"~     Ovarian cancer patients are considered platinum refractory if their disease worsens during~     primary platinum treatment or if they have no effect of the treatment. This constitutes a~     major therapeutic problem and new treatment approaches are highly needed.~      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both~     tumors it has effect in patients refractory to taxotere. Consequently, it could be~     anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.~   "
100505|NCT01741597|"~     This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance~     imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to~     the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's~     response to treatment~   "
100045|NCT01747603|"~     This pilot study will examine the feasibility of conducting a large randomized clinical~     trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing~     complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational~     age. 1) Study Process: Success will be achieved if 80% of a target population of 100~     subjects is met within the first 6 months of recruitment being initiated. 2) Study~     Resources: Success will be achieved if 80% of follow up appointments are scheduled in a~     timely manner and if specialized LPTB physicians in the intervention complete assessments~     75% of the time in the allocated time frame and 3) Scientific: 95% data completeness on data~     collection forms will be identified as success~      A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a~     programme and standardized follow-up and guidelines for the care of LPTB infants after~     discharge from hospital do not exist. Until recently, the incorrect assumption has been that~     these infants are healthy and have limited risks compared to term infants.~      The study's main question, in addition to assessing the feasibility of this pilot, is: Do~     differences exist in short-tem clinical and developmental outcomes among LPTB infants~     enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when~     compared to infants randomized to current pragmatic management? A RCT will provide evidence~     for the development of guidelines for the follow-up of LPTB infants in the first 6 months of~     life to reduce complications, readmissions and developmental problems.~      The results of this study can be generalized to tertiary care and community hospitals and~     the general population.~   "
100046|NCT01747590|"~     The primary goal of this double-blind, placebo-controlled, within-subjects functional~     neuroimaging study is to examine the extent to which the hypnotic zolpidem decreases brain~     activity in regions of the brain known to process emotional information. Although zolpidem~     is an effective sleep-aid, its ability to engender anti-anxiety effects is equivocal, yet~     promising. Zolpidem's activity during tasks that engage anxiety-related processes in the~     brain will be compared to that of the known anxiolytic drug alprazolam, a positive~     comparator caffeine, and placebo. A secondary goal of this study is to compare the~     subjective drug effects, or how individuals feel, following the interventions. These~     measures will be used to determine the existence of brain-behavior relationships, thus~     demonstrating that imaging is an important tool for informing us about how drugs produce~     their effects in the brain.~   "
100047|NCT01747577|"~     The purpose of this study is to demonstrate superiority of the solifenacin succinate~     (treatment) over the placebo (control) based on the change from the baseline in the mean~     number of urgency episodes per 24 hours after 2 weeks.~   "
100048|NCT01747564|"~     The purpose of this study is to evaluate safety and absorption, distribution and elimination~     of mirabegron after oral administration to Chinese subjects.~   "
100049|NCT01747551|"~     This research study is a Phase II clinical trial to test the safety and effectiveness of the~     investigational drug Ziv-aflibercept in combination with mFOLFOX6 compared to mFOLFOX6~     alone. The drugs used in mFOLFOX6 include Fluorouracil (5-FU), Leucovorin and Oxaliplatin.~      In patients with esophagogastric cancer, mFOLFOX6 has been used in both clinical trials and~     standard of care. Investigational means that the FDA has not yet approved this combination~     for the treatment of esophagogastric cancer.~      Every person has molecules in their bloodstream called vascular endothelial growth factors~     (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.~     Cancer tumors hijack this mechanism because they need new blood vessels and oxygen to grow.~     Ziv-aflibercept is an antibody, a targeted therapy called a VEGF Trap, that traps~     (binds) these VEGFs and prevents the cancer from using them to grow. Ziv-aflibercept has~     recently been approved by the FDA for patients with treatment-resistant colorectal cancer.~     Patients who received standard 5-fluoruracil based chemotherapy pus ziv-aflibercept lived~     significantly longer than those patients who received standard 5-fluoruracil alone.~      In this research study, investigators will see if adding ziv-aflibercept to standard~     chemotherapy (mFOLFOX6) works better than mFOLFOX6 chemotherapy alone in patients with~     metastatic or unresectable esophagogastric cancer.~   "
100050|NCT01747538|"~     The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of~     recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently~     controlled with systemic treatment.~   "
100051|NCT01747525|"~     The primary objective of this study is to characterize coronary artery blockages as~     determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.~   "
100052|NCT01747512|"~     Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc~     Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with~     ten patients using this imaging agent showed that it was safe and produced images with the~     same pattern as generator produced Pertechnetate. This study is now being done in larger~     numbers of patients to again show that the imaging pattern of both agents is the same, and~     to again demonstrate its safety.~   "
100053|NCT01747499|"~     The purpose of this phase I/II study is to define the maximum tolerated dose of 5-AzaC and~     the effect on grade II-IV GvHD when given after matched unrelated donor transplant (MUD).~   "
100054|NCT01747486|"~     This is a randomized, open-label, parallel group study to determine the optimal dose of~     CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing~     tandem TCR Zeta and 4-1 BB co-stimulatory domains) of the two dose levels being assessed~     (1-5x10e8 vs. 1-5x10e7 CART-19 cells). This trial will be conducted in two stages.~   "
100055|NCT01747473|"~     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse~     subject population during severe signal interference over a specified saturation range.~   "
100056|NCT01747460|"~     To determine accuracy specifications of the Pulse oximeter.~   "
100057|NCT01747447|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among a sub-cohort of 770 participants in~     VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs.~     placebo on skeletal health and body composition.~   "
108940|NCT01630304|"~     The purpose of this study is to determine whether weekly text-messages improve retention in~     care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).~   "
100058|NCT01746693|"~     Amblyopia is a developmental condition that is characterized by reduced vision of the eye~     due to the presence of a sensory impediment during visual development, such as strabismus~     (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life.~     Recent studies in humans and animals point towards a cortical locus for the processing~     deficit in amblyopia, revealing sensory deficits at the signal cell level. If changes in~     retinal neuronal function are also present, is unknown.~      Like in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon~     has been measured by different study groups with non invasive techniques in the brain and~     retina. It has been shown in previous studies that stimulating the retina with diffuse~     luminant flickering light increases retinal vessel diameter and blood flow. However, it is~     unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the~     introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly~     access the vascular response in the brain to visual stimuli.~      Therefore, the aim of the present study is to investigate the effect of luminant flickering~     light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also,~     oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment~     of retinal function. Additionally, a high resolution image of the visual pathway will be~     taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are~     present.~   "
100059|NCT01746680|"~     The aims of this study are to assess the efficacy and safety of tacrolimus in patients with~     active rheumatoid arthritis(RA). EULAR(European League Against Rheumatism) response at week~     24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.~   "
100060|NCT01746667|"~     The current study aims at comparing the efficacy of exposure in vivo and exposure via~     virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will~     be randomized to either one of the active conditions or to a waiting-list condition.~     Participants on the waiting-list will be offered either exposure in vivo of in virtual~     reality after a waiting period of five weeks. Levels of psychopathology will be assessed at~     pre- and post-treatment as well as three and 12 months after treatment.~   "
100061|NCT01746654|"~     The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe~     and well tolerated in healthy volunteers and in chronic kidney diseases patients on~     dialysis, (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus~     aureus) in humans.~   "
100062|NCT01746641|"~     The purpose of this study was to compare remifentanil and propofol for sedation of patients~     during endoscopic gastrointestinal procedures.~   "
100063|NCT01746628|"~     When having certain types of outpatient surgery inside the uterine cavity some women~     experience heavy bleeding. The only method presently available for controlling such~     bleeding, short of removing the uterus, involves the placement of a balloon pressure device~     inside the uterine cavity. The pressure along with the patient's own natural clotting~     ability will generally stop the bleeding. However, this treatment usually requires at least~     a 24 hour stay in the hospital. The investigators are researching the use of a compound~     (FloSeal) already approved for use in other areas of the human body, as a method of~     controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and~     therefore is not yet an FDA approved indication for its safe use to control bleeding from~     the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal~     has on the uterine cavity.~      Twenty individuals will be included in this study at Northwest Hospital Center. All twenty~     individuals will be treated in the same fashion except ten of the participants will randomly~     be assigned to receive FloSeal and ten will not.~      Study participants are individuals currently scheduled to have a hysterectomy procedure,~     which involves surgically removing the uterus from the body for a previously determined~     standard of care treatment for a non- cancerous medical problem. Before performing the~     hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine~     cavity the following will be done. Once under anesthesia the uterine cavity will be~     subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the~     lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have~     FloSeal placed into their uterine cavity. The study participants will not know whether they~     received FloSeal or not. A balloon pressure device will then be placed into the uterine~     cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the~     balloon device will be removed. The hysterectomy will then be completed appropriately using~     standard methods and techniques. The uterus, once removed will be evaluated pathologically~     to determine the effects of the FloSeal upon the tissues of the cavity in those so treated~     and compared to the same analysis in those individuals who did not receive FloSeal. The~     pathologist will not know which patients received or did not receive FloSeal.~      This use of FloSeal is not currently an FDA approved use of the compound. The goal of this~     study is to obtain FDA approval for use in this situation.~   "
100064|NCT01746615|"~     Assessment of retinal vessel calibers combined with bidirectional Fourier domain optical~     coherence tomography (FDOCT) for measurement of retinal blood velocities is a new and~     sophisticated method for assessing retinal blood flow in humans. The valid measurement of~     retinal blood flow is of significant importance, because it is known that major ophthalmic~     diseases are associated with alterations in blood flow.~      As such, retinal vascular occlusive diseases represent a major cause of visual impairment~     and blindness. The prevalence of the disease is between 0.7 and 1.6%. Compression of the~     retinal veins at arterio-venous (AV) crossings plays an important role in the development of~     branch retinal vein occlusion (BRVO). The mechanical narrowing of the vessel lumen is~     supposed to be the mechanism behind this fact. The present study should elucidate how BRVO~     influences retinal blood flow at retinal vessel crossings in comparison to healthy control~     subjects. Retinal blood flow at retinal bifurcations will also be assessed. In addition, a~     fundus image will be taken to assess retinal oxygen saturation.~      For the first time we use a combination of a dynamic vessel analyzer (DVA) with~     bidirectional Fourier domain optical coherence tomography (FDOCT) to assess retinal blood~     flow. Whereas the DVA provides information concerning retinal vessel caliber, FDOCT provides~     laser Doppler information in addition to conventional optical coherence tomography, allowing~     the observation of blood flow dynamics simultaneously.~      In the present study we hypothesize that the DVA in combination with FDOCT is a suitable new~     tool for the assessment of blood flow in healthy subjects and in patients with BRVO.~   "
100065|NCT01747434|"~     Acute patients in Denmark are often admitted to Emergency Departments by their General~     Practitioner with a presumptive diagnosis.~      The aim of this study is to evaluate the diagnostic value of the pre-admission presumptive~     diagnosis and to assess if the presumptive diagnosis could be replaced by a number of~     symptom-based groups.~   "
100066|NCT01747421|"~     In Emergency Departments patients admitted with chest pain may suffer from non-significant~     to lifethreatening conditions.~      The aim of the present study is to develop and validate a referral model in chest pain~     patients which divide the patients with non- significant ECG changes into high risk and low~     risk groups for acute coronary syndrome.~   "
100193|NCT01745653|"~     Thus study consists of evaluating the effect of low level therapy on pain induced by~     insertion of an orthodontic device (the quadhelix). Each day during the first seven days~     post procedure, the level of pain will be reported on an analogic visual scale.~      As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will~     also be daily registered.~   "
100067|NCT01747408|"~     The proposed study was set up to evaluate the tolerability and safety of 25% human albumin~     (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500~     people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one~     third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been~     identified as the most important reason for neurological deterioration. CV may be due to~     multiple molecular mechanisms. The use of a neuroprotective agent with various actions,~     likes HA, would be important for prevention of CV and improved clinical outcome in patients~     with SAH. The proposed open-label, dose-escalation study will have important public health~     implications by providing necessary information for a definitive phase III clinical trial~     regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a~     maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA~     (0.625, 1.25, 1.875, and 2.5 g/kg) administered daily for seven days will be evaluated. The~     lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety~     threshold was defined based on data from previous studies. The Data and Safety Monitoring~     Board approved or disapproved advancing to the next higher HA dosage based on the evaluation~     of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and~     tolerability of the HA dosages and the functional outcome. The primary tolerability outcome~     was defined as the subject's ability to receive the full allocated dose of HA without~     incurring frank CHF that requires termination of treatment. Secondary safety outcomes were~     serious adverse events (including neurological and medical complications, and anaphylactic~     reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus,~     and seizures after treatment. The three-month functional outcome determined, by Glasgow~     Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact~     Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The~     timeline of the study is three years.~   "
100068|NCT01747395|"~     The investigators hypothesize that aerobic exercise training associated with respiratory~     muscle training will cause additional benefits compared to isolated exercise training or~     respiratory training in chronic heart failure patients.~   "
100069|NCT01747382|"~     Recent clinical studies have demonstrated that catheter-based renal sympathetic nerve~     ablation is safe and effective in treating patients with resistant hypertension. However,~     there is limited data on its safety and efficacy in patients with Chronic Kidney Disease.~      The investigators hypothesize that catheter-based renal sympathetic nerve ablation is safe~     and effective in the treatment of resistant hypertension in patients with Chronic Kidney~     Disease.~   "
100070|NCT01747369|"~     The aim of this study is to estimate the burden of disease due to pneumococci, other~     bacteria and viruses in the African meningitis belt. In a defined population of a sanitary~     district in northern Togo, during the period 2010 to 2013, the investigators enroll patients~     of all age with suspected pneumonia requiring hospitalisation or suspected bacterial~     meningitis. Patients are evaluated by bacteriology and molecular biology techniques on~     blood, cerebro-spinal fluid, nasal aspirates and by chest X-ray.~   "
100071|NCT01747356|"~     Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used~     in treating patients with coronary artery disease (CAD). The State Food and Drug~     Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent~     system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM~     patients and FDA has approved diabetic coronary lesion as a indication for using Resolute~     stent. Here the investigators set out a multicenter, non-inferiority study: the efficacy and~     safety of RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes~     (RESOLUTE-DIABETES CHINA) in purpose of identifying the efficacy and safety in Asia CAD~     correlated with diabetic population.~   "
100072|NCT01747343|"~     The investigators are interested in determining those procedures that prove to be most~     efficient and effective in facilitating continence (i.e., dry pants or the absence of~     soiled undergarments), appropriate eliminations (i.e., voids/stools in toilet), and~     independent requests/initiations to use the toilet. To assess the effectiveness of toilet~     training methods (procedures), data on toileting skills (in addition to each skill in a~     given child's curriculum) are collected across the school day (7:30 am-5:45 pm) by the~     classroom teachers. The primary dependent variables (toileting skills) are continence (i.e.,~     absence of soiled undergarments), appropriate eliminations (i.e., the number of voids/stools~     made in the toilet), and independent/self requests (i.e., communication by the child with an~     adult to use the toilet). The toileting procedures are implemented by classroom teachers~     (undergraduate practicum students) and implementation is monitored by classroom supervisors~     (graduate teaching assistants). Procedural effectiveness is evaluated on a daily basis by~     the graduate teaching assistants and on an at-least-weekly basis by faculty supervisors.~   "
100073|NCT01747330|"~     The purpose of this study is to evaluate the safety and tolerability of Creon micro in~     children younger than four years with pancreatic exocrine insufficiency.~   "
100074|NCT01747317|"~     Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for~     determining the physiologic significance of coronary artery disease (CAD), which will help~     physicians in clinical decision-making and decrease the medical cost, but its ability to~     identify patients with ischemia has not been adequately examined to date.~   "
100075|NCT01747304|"~     DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in~     osteoporosis patients. They provide detailed bone imaging in a low radiation setting.~     Hologic manufactures scanners that are able to perform high definition instant vertebral~     fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine~     fractures instantly and reliably at the same time they are having their yearly BMD. We wish~     to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the~     scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the~     femur in patients at risk for these debilitating fractures. In this proof of concept study,~     we propose to examine whether DXA scanners can provide a sensitive low radiation screening~     method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at~     risk.~   "
100076|NCT01747291|"~     Osteoporosis is a disease characterized by increased bone fragility and deteriorating bone~     micro-architecture. The main consequence of osteoporosis is low-trauma fractures, most often~     of the hip, spine and wrist. Recently, another type of low-trauma fracture, atypical femur~     fractures (AFFs), have received much attention. Little is known of the cause of these~     debilitating fractures; however, they have been associated with long term bisphosphonate~     use. What we currently know about AFFs is based on case reports or small case series, or~     studies using administrative databases or secondary analyses of bisphosphonate trials. While~     these reports provide some preliminary information on the relationship between long term~     bisphosphonate exposure and AFFs, detailed clinical data are absent. As we have established~     a network of specialists across southern Ontario our group is in a position to collect~     meaningful information on a larger group of patients who have experienced these debilitating~     fractures into a centralized AFF registry.~   "
100080|NCT01747226|"~     Bad breath or halitosis is caused by specific gases originating from the mouth or the~     expired air. In most cases the pathology lies within the mouth and in this case receives the~     name pathologic halitosis of oral cause or oral malodor. The aim of this study is to~     evaluate the immediate (masking) and long term (therapeutic) effect of commercially~     available mouth rinses in the treatment of oral malodor. For this volunteers with oral~     malodor detected by organoleptic evaluation and confirmed by the increase level of sulphur~     compounds in their breath (VSC) will be asked to use a designated mouthwash. The breath~     parameters will be assessed at baseline and 15' after the first rinse (15 ml, during 1~     minute) and over night at the end of a period of 3 weeks during which the volunteers rinsed~     twice a day (15 ml, 1 minute) with the assigned mouthwash. The short and long term effect of~     a stannous fluoride/amine fluoride/zinc rinse; a chlorhexidine/cetylpyridinium chloride/zinc~     product and a negative control(fluoride rinse and/or water) will be compared.~   "
100081|NCT01747213|"~     Background:~      - Alzheimer s disease (AD) is a brain disease that impairs memory, cognitive abilities and~     the ability to function independently. It is the most common cause of dementia in older~     people. It is caused by abnormal proteins in the brain that affect how neurons communicate~     with each other. Researchers are looking for drugs that can slow down the disease or treat~     its symptoms. One drug, called bisnorcymserine (BNC), may help improve brain function and~     symptoms in people with AD. BNC is designed to block a chemical that affects how neurons~     communicate with each other. Researchers want to see how BNC works in healthy older~     volunteers.~      Objectives:~      - To look at how the body processes bisnorcymserine taken by mouth and how safe it is for~     healthy older volunteers.~      Eligibility:~      - Healthy volunteers at least 55 years of age.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood and~          urine tests.~        -  Within 3 weeks from the screening visit, participants will come to the National~          Institute on Aging clinical unit for a 2-night stay. On the morning of the second day,~          they will take either a BNC capsule or a placebo. They will not know which tablet they~          are taking.~        -  Blood samples will be collected frequently throughout the second and third days of the~          study visit. The last blood sample will be collected about 32 hours after taking the~          study capsule. Participants will have heart function tests and other exams during the~          visit. Once the tests are done, they will leave the clinical center.~        -  Participants will have a final follow-up visit about 1 week after leaving the clinical~          center.~   "
100082|NCT01747200|"~     Background:~      - The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record~     these rhythms. When people identify the picture of a familiar object shown on a computer~     screen, the communication between certain regions of the brain increases. An EEG can detect~     these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these~     brain waves by slightly changing the brain s rhythms. Researchers want to see if changing~     brain rhythms with TMS interferes with the ability to identify pictures of familiar objects.~     This study will provide more information about how TMS can affect brain waves and behavior.~      Objectives:~      - To see if TMS can interfere with the brain s ability to identify pictures of familiar~     objects.~      Eligibility:~      - Healthy volunteers between 18 and 70 years of age.~      Design:~        -  This study requires two visits to the clinical center. The first visit will last about~          2 hours. The second visit will last about 4 hours.~        -  Participants will be screened with a physical exam and medical history.~        -  At the first visit, participants will have an object recognition test. Participants~          will look at pictures of several objects on a computer screen. They will then have to~          state whether the objects they see on the screen are familiar. The object recognition~          test will be done along with TMS.~        -  At the second visit, participants will have an EEG while taking the object recognition~          test. Brain waves will be monitored during the test. They will then repeat the test~          while having repetitive TMS to study its effect on object recognition. The participants~          will then take the object recognition test alone for a final time. This will make sure~          that TMS effects (if any) on the ability to identify familiar object images are no~          longer present.~   "
100083|NCT01747187|"~     Septic shock is a major cause of death in intensive care. Septic shock is often dominated by~     profound changes in organ functions, of which cardiac failure is one of the most severe. In~     septic shock, biological markers of cardiac stress are often elevated. It is not known to~     what extent this indicates structural damage to the heart, or in what way they correlate to~     echocardiographic signs of heart failure.~      Here, cardiac failure in ICU patients with septic shock is studied, using biological markers~     of cardiac stress, inflammatory parameters and echocardiography.~      Investigators hypothesize that biomarkers of cardiac stress correlate with echocardiographic~     signs of heart failure, and that they can predict an increased risk of death.~   "
100084|NCT01747174|"~     The purpose of this study is to determine whether intra-coronary adenosine or sodium~     nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if~     unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary~     Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO)~     parameters and infarct size as measured with cardiac MRI, compared with standard treatment~     following thrombus aspiration in patients presenting with ST-elevation myocardial infarction~     (STEMI).~   "
100085|NCT01747161|"~     In this study we will investigate the efficacy and safety of infiltration of the vestibulum~     vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia.~     In literature covering this subject we find that the prevalence of this condition is between~     10 and 15%. Especially young, sexually active women suffer from this problem and some of~     them are not capable of having sexual relations with their partner because of this burning~     pain.~      The most probable explanation for the physiopathological mechanism is an increase of nerve~     endings in the epithelium of the vestibulum, with an increase and activation of pain~     receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a~     higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain~     and a lower capacity of relaxation.~      Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells.~     That way it can decrease the increased tension of the pelvic floor muscles Botox also~     inhibits the pain receptors in the vestibulum.~      Patients will be recruited through the gynecology consultations. Every patient with~     localized provoked vulvodynia that has tried previous treatments (pelvic floor muscle~     therapy, antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If~     positive and there are no underlying diseases, the patient will be invited to participate in~     the study and after oral and written informed consent, will be included in the study~     population. Every 6 weeks there will be given injections with 50 units of botulin toxin, on~     6 different spots in the vestibulum. 50 % of the subjects will receive physiological water~     instead of Botox (control population). After 3 sessions, we will assess if there is any~     difference in provoked pain in treated patients vs. placebos through Q-tip testing.~   "
100116|NCT01746758|"~     The study hypothesis is that managed referral of patients at community level (from drug~     stores) increases uptake of reproductive health (RH) services at dispensary and health~     centre levels.~      The intervention is currently being implemented in 2 districts (Magu and Sengerema) in~     Mwanza Region on the northwest shore of Lake Victoria. It is nested within the IntHEC~     Community Randomised Trial which aims to evaluate the impact of a complex RH intervention on~     the uptake and integration of reproductive health services in 2 Regions in Tanzania (Mwanza~     and Iringa) and Niger (Say and Aguie) respectively. 18 wards per region were stratified~     according to geographical and economic criteria and randomly assigned to intervention or~     comparison wards. The SMS intervention is being implemented in 9 intervention wards in~     Mwanza Region only. 9 wards are followed for comparison.~   "
100086|NCT01747148|"~     Background:~      - Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu~     causes only a mild illness, but some people can become seriously ill or even die from it.~     Currently, some pills and inhaled powders can be used to treat the flu, but they only make~     flu symptoms end about a day sooner. More treatment choices for the flu are needed,~     especially for those who become seriously ill. Researchers want to test a new drug,~     AVI-7100, that might keep a person who takes it from having a more serious case of the flu.~      Objectives:~      - To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.~      Eligibility:~      - Healthy volunteers of normal weight between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. A heart function test will also be performed.~        -  Participants will have either AVI-7100 or a placebo infusion. They will not know which~          infusion they have. . Participants will stay at the clinical center for a total of 8~          hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after~          the end of the infusion~        -  Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood~          and urine samples will be collected. A heart function test will also be performed.~        -  There will be a second part of the study that is separate from the first one.~          Additional people will receive either AVI-7100 or placebo to test their reactions to a~          specific dose.~   "
100087|NCT01747135|"~     Background:~      - Hydroxypropyl beta cyclodextrin (HPBCD) is being tested for a disease called Niemann-Pick~     disease type C1 (NPC1). NPC1 is a genetic disorder that results in gradual loss of nervous~     system function. Cholesterol and other fats have trouble moving out of the brain cells,~     which makes the cells work poorly and leads to symptoms. There is no treatment currently~     approved in the US for NPC1. Researchers want to test if it is safe to use HPBCD for NPC1.~     They want to see if it can help brain cells process cholesterol better.~      Objectives:~      - To test the safety and effectiveness of HPBCD for NPC1.~      Eligibility:~      - Individuals between 2 and 25 years of age who have been diagnosed with NPC1 and who have~     not already received HPBCD in an attempt to treat NPC1.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples for screening. They will also have neurological tests,~          including tests of hearing, speech and movement.~        -  Participants will have a lumbar puncture (also called a spinal tap) every month to~          deliver the drug to the spinal fluid that surrounds the brain. The length of the trial~          will be determined by the safety and efficacy information that is obtained.~        -  Treatment will be monitored with frequent blood and urine tests, cerebral spinal fluid~          tests, hearing and neurological exams.~   "
100088|NCT01747122|"~     The investigators plan to compare epidurals versus wound catheters for effects on pain~     relief and recovery following open liver surgery.~   "
100089|NCT01747109|"~     Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure~     after crash induction remains a critical event.~      The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is~     more efficient than the face mask for preoxygenation before orotracheal intubation after~     crash induction in acute hypoxemic respiratory failure~   "
100090|NCT01747096|"~     Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in~     Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in~     routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).~      Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected~     results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy~     octreoscan ®, with a potential impact on the therapeutic management of patients.~   "
100091|NCT01747083|"~     This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl~     sustained release) 50/1000mg(25/500mg x 2tablets)~   "
100092|NCT01747070|"~     The objective of this study is to evaluate the efficacy of transcranial direct current~     stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing~     pain, improving functional capacity and functioning of the neuro-immune-endocrine system in~     patients with chronic pain due to knee osteoarthritis.~   "
100093|NCT01747057|"~     Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will~     improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious~     effects of fluid overload.~   "
100094|NCT01747044|"~     Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men.~     In France, the prevalence is 1.6% according to a French study conducted in 2009 and~     published in 2011 by Serge Perrot et al.~      The definition of fibromyalgia was recently amended with particular consideration of~     cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR~     classification. Several factors are in favor of a malfunction of the central modulation of~     pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious~     inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse~     noxious inhibitory controls) are altered with less pain inhibition than controls.~     Dysfunction of the central pain modulation is widely described in the literature and~     contributes to pain complained of fibromyalgia.~      According to the Recommendations of the European League Against Rheumatism (EULAR) 2006,~     antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an~     antidepressant known and used in major depressive disorder according to its marketing~     authorization but is also part of the molecules used in the treatment of chronic neuropathic~     pain and fibromyalgia according to the recommendations of the EULAR. A review included five~     double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo~     over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of~     participants treated for each dose of milnacipran on the criteria of at least 30% pain~     relief Impression and global change. Substantial improvement with milnacipran compared to~     placebo has been shown.~      To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug~     treatment has not been shown.~      This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be~     predictive of the efficacy of milnacipran.~   "
100095|NCT01747031|"~     The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance~     of iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of~     significant obstructive coronary artery disease, defined by invasive fractiona flow reserve~     (FFR) as the reference standard.~   "
100117|NCT01746745|"~     This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy~     participants to study how the body absorbs and removes LY2940680 from the blood. This study~     is for research purposes only and is not intended to treat any medical condition.~   "
100194|NCT01745640|"~     The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide~     and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or~     translocation (4;14)~   "
100195|NCT01745627|"~     Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign~     pigmented and vascular lesions and scars~   "
100096|NCT01747018|"~     Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for~     increasing the rate of cure in bone and soft-tissue regeneration, although there are very~     few clinical studies regarding the treatment of articular cartilage damage. Therefore, our~     study proposes non-surgical intervention for patients with articular cartilage damage and~     who are experiencing knee pain caused by this damage.~      This study was conducted as a single medical center. It was an uncontrolled, prospective~     clinical trial, and the study subjects included 44 patients who were suffering from early~     osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and~     were included in the study irregardless their sex. PRP was injected twice intraarticulary~     within an interval of four weeks. The pain scores and functional scores were compared two~     months, four months, and six months following the second injection was completed, using the~     VAS, the Lysholm knee scale, and the Cincinnati knee rating system.~   "
100097|NCT01747005|"~     The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on~     inflammatory response after abdominal hysterectomy.~   "
100098|NCT01746992|"~     T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the~     patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and~     predisone)is less than 30%.High dose intensive chemotherapy doesn`t demonstrate better~     response. At present, there is no standardized treatment protocol for this kind of lymphoma.~      Between 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data~     on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the~     Northern Region of England and Scotland,which is a rare and aggressive type of peripheral~     T-cell lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine,~     etoposide/methotrexate)-ASCT was piloted for patients eligible for intensive~     treatment,followed by auto-stem cell transplantation.Five-years PFS and OS were 52% and 60%~     respectively, significantly improved compared with the historical group treated with~     anthracycline-based chemotherapy. The encouraged results were extended to the peripherial T~     cell lymphoma-non specified(PTCL-nos).~      Past studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin~     in vitro based on its high concentration in tumor cells. Clinical data also presented~     equivalent even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The~     aim of our study is to compare the response and survival rate of CTOP/ITE/MTX~     (cyclophosphamide, vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin,~     etoposide/methotrexate) with those of CHOP regimen,looking forward to its superiority in~     efficacy and safety for the de novo young patients with T cell lymphoma.~   "
100099|NCT01746979|"~     This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in~     combination with TH-302 compared to gemcitabine in combination with placebo in subjects with~     locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects~     will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until~     there is evidence of progressive disease, intolerable toxicity, or the subject discontinues~     from the trial for other reasons (for example, withdrawal of consent). The primary efficacy~     endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the~     primary and secondary endpoints will be reached when 508 events (deaths) will be reported.~     No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB)~     will provide periodic evaluations of the unblinded safety data to ensure subject safety and~     the validity and scientific merit of the study. A total of 660 subjects will be enrolled.~   "
100100|NCT01746966|"~     1. Investigate Gleno-Humeral Joint (GHJ) by anterior approach:~           A - Measurement of GHJ thickness at 3 points and average value calculation on body~          supine position and with arm supinated, maximal externally rotated with elbow angle 90~          degrees~             -  By longitudinal access with transducer position laterally to coracoids along to~               the GHJ line, located as diagonal form lower to forward and lateral direction with~               demonstration the joint cartilage posteriorly and subscapular tendon anteriorly~               (Fig.4)~             -  By transversal access with 90 degrees to longitudinal and at 3 points: upper with~               coracoids visualization, middle and lower (Fig.5-7).~           B - Measurement of rotator interval with assessment of width and higher.~        2. Comparison of the data with results of classic values have been received by posterior~          and inferior (axillar) approach.~        3. Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy~          controls~   "
100101|NCT01746953|"~     We will evaluate the effect of red blood cell (RBC) transfusion on fatal and non fatal~     events according to baseline risk of death in an international cohort of trauma patients~     (CRASH-2 trial). The following outcomes will be considered: death from all causes, death due~     to bleeding, death due to multiorgan failure, death due to vascular occlusive events and non~     vascular occlusive events. Non fatal outcomes include: myocardial infarction, stroke, deep~     vein thrombosis and pulmonary embolism.~   "
100102|NCT01746940|"~     This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and~     efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through~     accessible mucous membranes of the nasal cavities.~   "
100103|NCT01746927|"~     This investigation was designed to assess if the the position of esophageal entrance would~     detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized,~     paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).~   "
100104|NCT01746914|"~     72 hours after lung transplantation, patients undergo a positron emission tomography (PET)~     scan and a computed tomography (CT) scan in order to analyse lung function and morphology.~      Aim of the study is to analyse complications onset (in particular primary graft~     dysfunction), and evaluate 90 days mortality after lung transplantation.~   "
100105|NCT01746901|"~     The main purpose of this study is to determine if oxycodone and naltrexone combination~     capsules (ALO-02) have the potential to be abused.~   "
100118|NCT01746732|"~     The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives~     (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones~     found in the blood will be measured and compared when taken alone and when taken with~     evaceptrapib. Each woman will participate in two study periods. Information about any side~     effects that may occur will also be collected.~   "
100506|NCT01741584|"~     The aim of the study is to investigate whether exercise improves cognitive and motor~     functions in Parkinson's disease. To test this hypothesis, the researchers study general~     brain functions in subjects with PD during a 6-months exercise program.~   "
100106|NCT01746888|"~     Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in~     the Emergency Department do not currently exist. These patients often have atypical~     presentations which can complicate diagnosis and treatment. The development of an~     antimicrobial stewardship program for Emergency Department older adult patients can~     ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This~     research study involves data collection from enrolled subjects and treating physicians. The~     data will be collected using a patient interview which will be answered directly by the~     patient or caregiver. Additional surveys will be administered to the Emergency Department~     treating physician and subsequent physician. Additional data will be abstracted from the~     Emergency Department chart and from additional charts that often accompanies the patient to~     the Emergency Department. A physician adjudication process will occur if there is~     disagreement in diagnosis between the treating Emergency Department physician and succeeding~     physician.~   "
100107|NCT01746875|"~     The purpose of this study is to determine treatment effects in patients with retinal pigment~     epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with~     newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to~     either treatment or observation. The treatment group will first be given injections with~     anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any~     effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed~     for a period of 2 years. It is hypothesized that treatment stops the progression of the~     disease and stabilizes the vision in this subgroup of patients with AMD.~   "
100108|NCT01746862|"~     This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group~     controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects~     will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose,~     for 12 months (12 months of treatment in the test group, and 6 months of no treatment and~     then 6 months of treatment in the control group).~   "
100109|NCT01746849|"~     The purpose of this study is to help determine if palifermin and leuprolide acetate can help~     the immune system recover faster following a stem cell transplant. Blood stem cells are very~     young blood cells that grow in the body to become red or white blood cells or platelets. The~     transplant uses stem cells in the blood from another person. The donor can be a family~     member or a volunteer donor. This is called an allogeneic stem cell transplant.~      The investigators want to see if palifermin and leuprolide acetate can help the immune~     system recover faster after an allogenic transplant because experiments have shown they may~     be able to do this.~   "
100110|NCT01746836|"~     The goal of this clinical research study is to learn if ponatinib can help to control CML in~     chronic phase. The safety of this drug will also be studied.~      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein~     responsible for causing CML. This may cause the cancer cells to die.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the~     location of the clot, this could cause a heart attack, a stroke, severe damage to other~     tissue, or death. A blood clot may occur within 2 weeks after you start taking the drug.~     About 25% (1 in 4) of patients taking the drug form an abnormal clot. Blood clots can occur~     in patients that do not have other known risk factors for forming clots. If you develop a~     blood clot, you will need to stop taking ponatinib. In some cases, emergency surgery could~     be needed to remove the clot and restore blood flow.~   "
100111|NCT01746823|"~     There is currently no medication for containing KC, nor any adequate biomarkers to predict~     the disease. Furthermore, there is considerable confusion in the field regarding the~     pathophysiology of the disease and involvement of inflammation. To that end, this study is~     designed to address some of these questions by determining the proteomic profiles of KC~     patients with different clinical grades. This relatively large cohort study is expected to~     yield significant information regarding the molecules that are deregulated during~     progression of KC and may provide a framework to assign diagnostic biomarkers and~     therapeutic intervention points.~   "
100112|NCT01746810|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy when given together with ablation therapy in treating patients with non-small cell~     lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a~     high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave~     ablation kills tumor cells by heating them to several degrees above normal body temperature.~     Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Giving ablation therapy together with stereotactic body~     radiation therapy may kill more tumor cells.~   "
100113|NCT01746797|"~     This study assesses risk factors for depressive relapse in women undergoing fertility~     treatment with histories of major depressive disorder (MDD) or bipolar disorder. The study~     is focused on the acute risk factors of depressive relapse.~      The investigators hypothesize that risk for depressive relapse will be greater among women~     who stop antidepressants compared to those who continue treatment with these agents.~   "
100114|NCT01746784|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR~     function and inflammation in adult cystic fibrosis subjects who are homozygous for the~     F508del-CFTR mutation.~   "
100115|NCT01746771|"~     [Phase I] The main objective of this study is to evaluate the safety, tolerability and~     determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and~     Trastuzumab~      [Phase II] The main objective of this study is to evaluate anticancer activity through~     determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and~     Trastuzumab in patients with HER-2 positive advanced gastric cancer~   "
100119|NCT01746719|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy, adult human subjects.~   "
100276|NCT01744574|"~     Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing~     impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in~     Project I we are proposing a double-blind randomized controlled trial to assess the role of~     exogenous progesterone on impulsivity and smoking cessation in a sample of males and females~     who are motivated to quit smoking.~   "
100120|NCT01746706|"~     Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently~     considered to be a priority for research, as disease modifying therapies are being~     evaluated. Many studies focus on the functional and morphological assessment of the~     hippocampal formation. However, neurofibrillary tangles, associated with cognitive deficits,~     initially affect the anterior subhippocampal cortex (transentorhinal, entorhinal and~     perirhinal cortex) before reaching the hippocampus. Studies from our group have tried to~     investigate if the assessment of subhippocampal regions using cognitive tools and~     neuroimaging techniques could contribute to the diagnosis of AD at a very early stage.~      In a previous project, the investigators included 40 patients with single domain amnestic~     MCI (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI~     patients with a profile of subhippocampal dysfunction (impaired performance on a visual~     recognition memory task) display other clinical as well as imaging profiles of patients with~     early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently~     under way. Preliminary data indicates that evaluating the subhippocampal region using visual~     recognition tasks is highly predictive of AD over 6 years.~      The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer~     (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that~     define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach~     will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can~     contribute to the early diagnosis of AD.~   "
100121|NCT01746602|"~     Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of~     dry eye syndrome with all known consequences such as ocular discomfort and epithelial~     keratitis. Given that thinning of the tear film appears to be a risk factor for the~     development or the aggravation of dry eye syndrome, the current study seeks to investigate~     whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs~     in healthy subjects.~      For this purpose, tear film thickness will be measured at baseline and after single~     instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of~     20 subjects will receive no drug and will serve as a second control. Drug effects on tear~     film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear~     film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol~     without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity~     (Genteal HA, Hylo-Comod, Thealoz).~   "
100122|NCT01746589|"~     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic~     LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight®~     Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of~     contrast sensitivity and improvement of postoperative visual acuity results.~   "
100123|NCT01746576|"~     The purpose of this study is to determine whether analysis of near infrared absorbance~     signals that occur at different frequencies might provide information about the difference~     in oxygen saturation between arterial and venous blood.~   "
100124|NCT01746563|"~     To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal~     photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral~     proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA),~     mean change in central retinal thickness (CRT) as measured by time-domain optic coherence~     tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).~   "
100125|NCT01746550|"~     The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent~     in the treatment of superficial femoral artery and proximal popliteal artery blockages in~     Japanese patients.~   "
100126|NCT01746537|"~     A prospective, observational, case series investigating the feasibility of utilizing OCT~     scans of the anterior chamber of eyes with uveitis.~   "
100127|NCT01746524|"~     This post-marketing investigation will evaluate the functional knee performance of Subjects~     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one~     of four contemporary knee configurations will be pooled to establish a contemporary dataset.~      The primary objective of this study is to evaluate the pre-operative (approximately -90 to~     -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative~     functional performance improvement for the Attune™ primary, cemented TKA system as measured~     by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score~     (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant~     configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining~     rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and~     posterior stabilized rotating platform (Attune™ PS RP).~   "
100128|NCT01746511|"~     The purpose of this study is to find out if giving glycerin suppositories will help decrease~     the length of time premature infants need phototherapy.~      The investigators hypothesize that glycerin suppositories (initiated along with~     phototherapy) will have no effect on reducing duration of phototherapy in premature infants~     with jaundice.~   "
100129|NCT01746498|"~     The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham~     transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal~     cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer~     disease (AD).~      Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable~     AD according to the criteria of the National Institute of Neurological and Communicative~     Disorders and Stroke Alzheimer Disease and Related Disorders Association [NINCDS-ADRDA] were~     included in this study) were randomly classified into one of three groups (eleven for each~     group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal~     tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10~     consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE),~     psychometric assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult~     Intelligent scale) were assessed before, after 10th sessions, and then after 1 and 2 month.~     Cortical excitability was assessed in both hemispheres before and after the end of sessions.~     Neurophysiological evaluations included resting and active motor threshold (rMT and aMT),~     and cortical silent period (CSP).~      At the time of recruitment, none of the patients taking antidepressants, or neuroleptic,~     sedative-hypnotic drugs for at least two weeks before the assessment. All participants or~     their caregivers will give informed consent before participation in the test and after full~     explanation of the study protocol.~      Outcome: The real group received (anodal and cathodal) tDCS are expected to have more~     improvement on cognitive functions compared to sham tDCS group. tDCS is considered new~     adjuvant non pharmacological therapeutic tool for management of AD patients with mild to~     moderate degree dementia.~   "
100130|NCT01746485|"~     To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers~   "
100179|NCT01745835|"~     comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in~     two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy~     preparation.~   "
100131|NCT01746472|"~     Effective evidence-based interventions exist for smoking cessation delivered over the~     Internet, but consumer acceptance and adherence remains low. Scalable and efficient~     mechanisms to disseminate these interventions online are needed, and existing online social~     networks provide a potential mechanism. This is a proposal for a randomized, factorial trial~     of the dissemination of an evidence-based intervention through the massive Facebook social~     network, with the goal of determining intervention characteristics that drive viral spread.~   "
100132|NCT01746459|"~     Currently, the health care that people receive is approximately 20 years behind up-to-date~     research findings. Developing ways to narrow the gap between evidence and practice is an~     important research focus in continuing care facilities, especially when one considers that~     the demand for these facilities is estimated to increase ten-fold in the next 25 years. In~     Alberta, there are an estimated 27,400 healthcare aides working in the continuing care~     sector. Developing reminders targeting these care providers will increase the likelihood~     that the significant resources invested to promote the uptake of research findings will lead~     to sustained practice change and, ultimately, improved client outcomes. The purpose of the~     START project (Sustaining Transfers through Affordable Research Translation) is to help~     bridge this gap between research and practice in supportive living and long-term care~     facilities by studying the effectiveness of reminder interventions to support the~     sustainability of a research-based mobility innovation. In particular, the project will~     evaluate the frequency and intensity of reminders that maintain the daily practice of~     healthcare aides to carry out a mobility innovation with clients in 24 supportive living and~     long-term care facilities. We will compare monthly versus every three month reminders, and~     we will compare paper-based reminders (like a sticker on a chart) and reminders provided by~     a healthcare aide peer. Using interviews, questionnaires and observations, the START project~     will also evaluate the processes that inhibit or promote the uptake of the mobility~     innovation by healthcare aides in their daily practice. In building this bridge between~     research evidence and practice, we will work closely with stakeholders at all levels of~     healthcare delivery (e.g. healthcare aides, facility leaders, policy makers and researchers)~     throughout the study. We expect our collaboration to contribute to sustainable innovations~     in the continuing care sector and, in particular, to the sustained use of an affordable~     mobility innovation in supportive living and long-term care settings.~   "
100133|NCT01746446|"~     The purpose of the study is to test a new model of care for patients with an ongoing or~     significant medical condition.~   "
100134|NCT01746433|"~     The main objective of this study is to compare the percentage of patients that successfully~     pass from a laying position to a sitting position in less than 10 seconds between study~     arms:~        -  experimental arm: these patients will use the ERGONOME device to help them sit up~        -  standard arm: these patients will use traditional hanging triangle bar to help them sit~          up~   "
100135|NCT01746420|"~     The purpose of this study is to determine whether recombinant human platelet-derived growth~     factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis~     elbow).~   "
100136|NCT01746407|"~     Procure blood specimens from individuals presenting to the emergency department (ED) with~     signs and /or symptoms of systemic infection or sepsis. The samples will be used for~     research and development activities related to sepsis, infections, etc.~   "
100137|NCT01746394|"~     The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the~     enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150~     African American women in their early second trimester of pregnancy. The control arm,~     Parents as Teachers, is an evidence-based approach to increase parental knowledge of child~     development and improve parenting practices. The experimental arm, Parents as Teachers~     Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical~     activity components specifically designed for the gestational and postnatal periods. Both~     arms of the intervention will be implemented by community-based, trained Parent Educators.~     The comparative effectiveness of the two intervention arms on weight status, dietary intake,~     and health behaviors of mothers and their infants will be assessed. The Delta Healthy~     Sprouts Project will determine if a novel, scalable, lifestyle intervention can improve the~     health of African American women and their children at high-risk for obesity and chronic~     disease.~   "
100138|NCT01746381|"~     Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients~     with ALS with worsening symptoms or deteriorating respiratory function, and has been~     recommended by the American Academy of Neurology (AAN) practice parameter for ALS.~      This study will compare the current standard BiST mode of ventilation with the new iVAPS~     mode. The main study hypothesis is that the iVAPS mode, initiated in a single daytime trial,~     will result in a reduction of the number of respiratory therapist interventions and changes~     in ventilator settings as compared with the standard BiST mode. This will be assessed over a~     period of one year. In addition this study will test whether the iVAPS mode is superior to~     BiST mode with respect to: comfort and ease of use; improvement in nighttime and daytime~     symptoms of hypoventilation; compliance (hours used per day); physiologic parameters~     (daytime and overnight oxygen saturation and transcutaneous CO2 level).~   "
100139|NCT01746368|"~     Objectives: The objectives of the pilot study were to (1) test the feasibility of~     recruitment, randomization, and retention; (2) test the feasibility of a standardized~     Nurse-Supported Advance Care Planning Intervention; (3) evaluate the feasibility of the~     assessment process and data collection procedures; (4) evaluate the Veterans' satisfaction~     with the intervention and their Advance Directive decisions; and (5) evaluate preliminary~     effects of the Nurse-Supported Advance Care Planning Intervention.~      Research Design: This was a prospective, randomized, controlled, unblinded pilot study.~     Alabama Veterans who received care through the Tuscaloosa VA Medical Center were randomized~     to either the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual in a 2:1~     ratio respectively. Data related to recruitment, randomization, and retention; study~     completion by subjects; completeness of data collection; Veterans' satisfaction; and~     preliminary effects of the intervention were collected, analyzed, and evaluated. The length~     of the study was one year.~      Methods: The setting for the study was Tuscaloosa VA Medical Center care sites. A~     convenience sample of fifty subjects was recruited from Tuscaloosa VA outpatient clinics~     including Selma, residential settings, Home Based Primary Care, and the Mobile Health Unit.~     The level of care of subjects was all-inclusive, excepting current Hospice or Palliative~     Care. Selection procedures included self-referral and referral by Tuscaloosa VA Medical~     Center staff. Entry requirements were the meeting of all inclusion criteria and verification~     of no exclusion criteria. The Nurse-Supported Advance Care Planning Intervention was a~     manualized education, support, and guidance session provided by a Registered Nurse that~     included information about risks, benefits, and alternatives of specific choices. The~     Care-as-Usual was a session with the social worker who explained what the Advance Directive~     is, and guided the Veteran regarding the process of completing the Advance Directive~     document, without providing information about risks, benefits, and alternatives of specific~     choices. Study enrollment period was six months. The primary study outcome measure was~     Advance Directive completion rate. This pilot was not a hypothesis testing study. The~     underlying hypothesis of the eventual full study is that the Nurse-Supported Advance Care~     Planning Intervention is associated with Advance Directive completion rates at least~     comparable to that of the As-Usual care.~      Significance: This study supports the Veterans Health Administration (VHA) mission to~     provide Veteran-centered care. It provides important information needed to plan a full study~     of the effectiveness of a specific Nurse-Supported Advance Care Planning Intervention to~     facilitate Advance Directive completion by rural Alabama Veterans.~   "
100196|NCT01745614|"~     The objective of this study was to confirm if two formulations of nimesulide tablets are~     bioequivalent.~      Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference~     product Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage~     was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-40~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
100140|NCT01746355|"~     Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and~     treatment, between specialist not have consensus about the pathophysiology. It is possible~     consider this entitie a potential neuropathic cause without pathological signs. It knows the~     repetitive transcranial magnetic presents good results in the treatment of chronic pain~     coditions. The aim this study is evaluated the thresholds and excitability cortical in~     patients with AFP and verify the patterns of improvement in pain for patients undergoing~     rTMS compared to controls, as well as the therapeutic response to neuromodulation~     procedures. This enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions)~     and evaluated through questionnaires (EDOF clinical record, McGill Pain Questionnaire,~     Visual Analogue Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4~     questionnaire, SF -36, brief pain inventory). At the end of the data will be statistically~     analyzed and expressed as mean and standard deviation, and analyzed by Student's t test,~     analysis of variance (ANOVA), Tukey-Kramer and Pearson correlation. The level of~     significance is 5%. The results will be published in journals indexed in the area both~     nationally and internationally and presented at conferences and scientific meetings.~   "
100141|NCT01746342|"~     Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse~     effects on daily functioning and quality of life. The investigators found in a recent study~     that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in~     multiple sclerosis (MS) patients. There was also a significant relationship between OSAH and~     higher fatigue scores in MS patients. Preliminary work from the investigators in this group~     of subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and~     other symptoms in some MS patients. However, it is now necessary to systemically test the~     effect of OSAH treatment in a randomized, controlled study, to be sure that it really does~     improve fatigue and other symptoms. The best treatment for OSAH in the general population is~     continuous positive airway pressure (CPAP). This treatment has been well tolerated by most~     MS patients who have used the device at the investigators' center. This project will~     therefore be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The~     effects of six months of CPAP treatment on fatigue as well as sleep quality, somnolence,~     pain, disability, and quality of life will be studied.~   "
100142|NCT01746329|"~     In the present study, muscle perfusion will be studied before and after an oral glucose~     challenge following a fasting period.~   "
100143|NCT01746303|"~     The aim of this study is to determine the efficacy of 6 months' dietary supplementation with~     omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older~     adults. The effects of each of these interventions alone will also be assessed in order to~     determine whether the combined treatment confers synergistic or additive benefit relative to~     the effect of each therapy.~   "
100144|NCT01746290|"~     Sudden cardiac arrest occurs when someone's heart stops beating unexpectedly. Each year,~     more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve~     survival: Call 911,start chest compressions and apply a defibrillator. Together, these~     actions can increase survival by up to 800%. The problem is that bystanders to cardiac~     arrest only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3~     of every 100 cardiac arrest cases. There are many people in the community who are trained~     and willing to provide help for cardiac arrest victims such as off-duty paramedics, fire~     fighters, nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of~     these people is nearby, but unaware of the emergency. The PulsePoint smartphone application~     enables these people to be notified by the local emergency 911 service when there is a~     cardiac arrest near to them. It can be freely downloaded to several common types of~     smartphones. When there is a cardiac arrest emergency, all nearby PulsePoint users are sent~     an alert from the 911 service. When the phones receive the alert, they ring, vibrate and~     display a text message saying CPR NEEDED. The user's current location and the exact~     location of the cardiac arrest are then displayed on a map. Nearby public access AEDs are~     also indicated on the map. The smartphone users can then go to provide chest compressions~     and use an AED while paramedics are on their way. A video at www.pulsepoint.org shows how~     this works. The objective of the investigators is to measure whether the PulsePoint~     smartphone application increases bystander CPR or AED use for victims of cardiac arrest~     outside the hospital. This project will happen in the City of Toronto. The investigators~     have a plan to get as many people as possible to download the application, focusing on~     health care professionals who know CPR. The investigators will set up a webpage that helps~     people download the software to their phone. The investigators will randomize 911 calls to~     have a PulsePoint alert sent or not. The investigators will use statistical analysis to~     measure whether sending an alert to a smartphone increases the chances of bystander~     resuscitation.~   "
100145|NCT01746277|"~     There are two different treatment modes for NSCLC patients who failed to epidermal growth~     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI.~     One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by~     EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So~     this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two~     different treatment modes.~   "
100146|NCT01746264|"~     Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents~     have a high prevalence of Vitamin D deficiency as well as evidence of endothelial~     dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with~     Vitamin D would lead to improvement in endothelial dysfunction.~   "
100147|NCT01746251|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness~     of an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is still being studied. It also means that the FDA has~     not yet approved afatinib for use in patients.~      In this research study the investigators are looking to see if taking afatinib after surgery~     works better when taken over a short period of time, compared to a long period of time.~   "
100148|NCT01746238|"~     The main purpose of this study is to test the safety, tolerability, maximum tolerated dose,~     and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy.~      Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to~     subjects with sarcoma who are enrolled in this research study and may only be administered~     under the direction of doctors who are investigators in this research study.~      This study is being done because sarcomas can recur after surgical resection (surgery for~     removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the~     same location as the original tumor or in distant sites such as the lung. Thus better~     treatments are needed.~      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug, combination of drugs, or combination of drugs with radiation. Phase~     I studies also try to define the appropriate dose of the investigational drug to use for~     further studies. Investigational means that the combination of drugs and radiation is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type~     of cancer.~   "
100149|NCT01746225|"~     Longer first line chemotherapy duration has recently been associated with a modest, but~     significant improvement in overall survival and a clinically meaningful and statistically~     significant improvement in progression-free survival, in metastatic breast cancer patients.~     Prolonging chemotherapy until disease progression, however, must be weighed against the~     detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the~     tolerability of prolonged chemotherapy administration strategy by studying alternative~     treatment schedules, while preserving and possibly improving treatment efficacy in this~     disease setting.~      The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®),~     represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an~     attempt to reduce the toxicity associated with standard taxane administration (caused by the~     use of chemical solvents) while increasing antitumor efficacy.~      The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged~     chemotherapy administration strategy. Each of three arms will be compared to a historical~     reference of seven-month median progression-free survival (PFS) based on the most recent~     trial with docetaxel as control arm to determine whether any of the three arms are worthy of~     further investigation.~   "
100150|NCT01746212|"~     The purpose of this study is to report the radiographic, clinical, and functional outcomes~     of a consecutive series of patients diagnosed with single or bilateral degenerative disc~     disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion~     (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for~     bony fusion and instrumentation.~      Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery [a~     surgical procedure that joins two or more lumbar vertebrae (small bones of the spine)~     together into one solid bony structure by approaching the spine through the abdomen (front~     of the body) and placing a bone graft in between the vertebral bodies where the disc usually~     lies], are invited to participate in an orthopaedic research study.~      This study will compare patients that have been treated with an anterior lumbar interbody~     fusion using InQu Bone Graft Extender & Substitute to published data for a stand alone~     spinal fusion surgery, where InFuse bone graft is placed between the transverse processes~     [small bony projections off the right and left side of each bone in your spine] of the~     affected vertebrae.~      X-rays, daily activities, and how patients are doing will be evaluated at specific time~     points during this study.~      The hypothesis of this study is that patients diagnosed with degenerative disc disease~     treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision~     through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented~     fixation have comparable radiographic (x-rays), functional (daily activities), and clinical~     (how the patient is doing) outcomes when compared to published data for use of InFuse in~     stand-alone fusion.~   "
100151|NCT01746199|"~     Given the resistance emergence of malaria in pregnant women receiving intermittent~     preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this~     infection among pregnant women infected by HIV it is urgent to seek a more effective~     alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually~     administered daily as a prophylactic mean to opportunistic infections for HIV infected~     patients, showed encouraging results in preventing malaria in pregnant women. However, these~     results must be confirmed by randomized trials, particularly in pregnant women.~      The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM),~     administered once daily with IPT-SP (3 curative doses spaced one month) on placental~     parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) >~     350 cells/mm3.~      The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP~     for placental parasitaemia. This might be due to the higher plasma concentration of~     cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could~     be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell~     count. In this study, the investigators will also test the hypothesis that the strains of~     Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps~     resistance markers.~   "
100152|NCT01746186|"~     The purpose of this study if to determine the specific contributions of energy intake and~     energy expenditure to changes in body weight and fat.~   "
100153|NCT01746173|"~     The current standard of care for the frontline treatment of peripheral T-cell lymphomas~     (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT).~     However, many patients are unable to get to ASCT or relapse after ASCT, with a poor~     prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and~     melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We~     therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and~     report the results of a phase 2 study of this regimen in patients with PTCL.~   "
100154|NCT01746160|"~     The aim of the study is to describe the changes found in C1 dental implants through their~     early healing period.~      Patients requiring a standard installation of one or two implants in the maxilla, without~     any need for bone augmentation, will be frequently followed for 90 days. In every meeting~     the implants' ISQ values (values denoting the implant stability as being measured by a~     dedicated, commercially available, appliance called 'Osstell').~      The implants' measured ISQ values will be used to describe the changes that may be found in~     the implants' stability through their healing period.~      At the end of the study the patients will be referred to their treating doctor for the~     completion of implants' restoration (i.e. crown).~   "
100155|NCT01746147|"~     The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic~     change of LPI occurrence during conditioning and at identifying LPI-predictive~     peri-transplant parameters. Further points of interest are the improvement of systemic iron~     overload (SIO) diagnostics and the correlation of different SIO parameters with outcome~     after transplantation. The results of this trial will help to design prospective~     interventional studies addressing therapeutic options in patients at risk for SIO-associated~     toxicity during allogeneic stem-cell transplantation (allo-SCT).~   "
100156|NCT01746134|"~     This study is a disease-based registry designed to follow patients with a DSM-IV-TR~     (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of~     schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care~     settings for up to 5 years. The registry seeks to describe the course of disease in~     schizophrenia, including cognitive function and negative symptoms, its treatment, and its~     burden of disease for participants, caregivers, clinicians, and society as a whole.~   "
100157|NCT01746121|"~     Amelogenesis Imperfecta (AI) are a heterogeneous group of rare genetic diseases transmitted~     according to various mode of inheritance (X-linked, autosomal dominant, autosomal recessive)~     affecting the formation/mineralization of tooth enamel. These diseases exist in isolation~     with clinical manifestations limited to the oral cavity or may be associated to other~     symptoms in syndromes. Many different genes (AMELX, ENAM, ENAMELYSIN or MMP20, KLK4, DLX3,~     FAM83H, FAM20A WDR72…) coding for enamel matrix proteins, enamel matrix degrading proteins,~     proteins involved in hydroxyapatite formation and growth and mineralization processes have~     been discovered responsible for the clinical phenotypes (hypoplastic, hypomineralized,~     hypomature) encountered in AI.~      Genes involved in enamel formation but not yet identified in association with any form of AI~     include: AMELY, AMELOBLASTIN, TUFTELIN, AMELOTIN, A Pin protein, ODAM (Odontogenic~     ameloblast associated).~      In this research protocol the investigators explore the phenotype including the enamel~     ultrastructure and the genotype of a cohort of patients presenting AI.~   "
100158|NCT01746108|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of~     GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having~     asplenia, splenic dysfunction or complement deficiencies.~      In addition, this study will include an age-matched control group of healthy children aged~     24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in~     the at-risk population to that of the general, healthy population one month after each~     pneumococcal vaccination.~   "
100159|NCT01746095|"~     The purpose of this study is to determine whether AeroVanc treatment is safe and effective~     in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis~     patients.~   "
100160|NCT01746082|"~     This is a Phase II open-label study in approximately 200, and up to 240, healthy males and~     non-pregnant females, aged 18 years and older. This study is designed to assess the safety,~     reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated~     influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age~     (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120)~     subjects >/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as~     15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be~     approximately 7 months.~   "
100161|NCT01746069|"~     Smoking remains a major risk factor for chronic diseases and is a real problem for health~     systems. The use of emerging technologies, such as mobile phone , may have a important role~     in smoking cessation programs through sending reinforcement messages when patients quits~     smoking.~      Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation~     program including health advice provided by a doctor and sending support messages to mobile~     phone of patients.~      Methods: Study design: Randomized single blind clinical trial. Study population: Patients~     over 18 who are willing to start a smoking cessation program, who have mobile phone, who are~     able to receive and send messages, and who have a score greater than 5 or equal to 5 on the~     Richmond scale.~      Sample size: 160 patients per arm to detect a difference in the percentage of smoking~     cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental~     group: Health advice and support messages to mobile phone patients.~      Control group: Health advice. Assessment of the primary endpoint: At 6 months~     (positive/negative coximetry test).~      Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry~     test) will be performed using logistic regression.~   "
100162|NCT01746056|"~     The goal of this study is to determine the safety and efficacy of the occlusive heat patch~     for the treatment of verrucae (warts).~   "
100163|NCT01746043|"~     The goal of this clinical research study is to compare armodafinil and minocycline when~     given alone or in combination to learn which is better for controlling side effects of~     chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack~     of appetite, and drowsiness).~      Armodafinil is designed to prevent excessive sleepiness.~      Minocycline is an antibiotic, which may help to reduce multiple symptoms.~      In this study, you may receive a placebo. A placebo is not a drug. It looks like the study~     drug but is not designed to treat any disease or illness. It is designed to be compared with~     a study drug to learn if the study drug has any real effect.~   "
100164|NCT01746030|"~     This study will evaluate the prevalence of geriatric syndromes in older adults with multiple~     myeloma, examine relationships between baseline geriatrics syndromes and initial treatment~     selection, and examine risk of functional decline.~      Relationship between baseline geriatric questionnaires and initial treatment selection in~     older adults with newly diagnosed multiple myeloma.~      Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and~     6 months.~      Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6~     months of follow-up in older adults with newly diagnosed multiple myeloma.~   "
100165|NCT01746017|"~     The aim of this trial is to evaluate the safety of the study drug in healthy people and~     people with diabetes. It will investigate how much of the study drug gets into the blood~     stream and how long it takes the body to get rid of it. Information about any side effects~     that may occur will also be collected.~      The study consists of two parts. Part A will study healthy participants in up to 4 dosing~     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3~     dosing periods over approximately 5 weeks.~   "
100166|NCT01746004|"~     This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299~     monohydrate in healthy participants. The study will determine how the body eliminates the~     radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or~     postmenopausal females, or sterile males. This study is approximately 8 to 15 days.~   "
100180|NCT01745822|"~     Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In~     Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of~     perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma,~     even if her infant receive specific immunoglobulin and vaccine.~      The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in~     HBV infected pregnant women and therefore reduce the risk of perinatal transmission/~     Pregnant women participating in this study will receive tenofovir or placebo during the last~     trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be~     compared between the two groups.~      The results of the study will help define policy to manage HBV infected pregnant women to~     prevent perinatal transmission.~   "
100167|NCT01745991|"~     The investigators plan to invite all children in the UK with biliary atresia, treated at the~     three national centres (Birmingham, Kings College and Leeds), over a three year period to~     take part in a randomised control study. The investigators aim to determine the~     effectiveness of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing~     intra-abdominal adhesions (scar tissue) and the morbidity caused by these adhesions in~     children treated with a Kasai hepatoportoenterostomy. Adhesions are common, if not~     invariable, after any abdominal surgery. They cause intra-abdominal organs to become stuck~     to each other and the abdominal wall. This means they are no longer completely free to slide~     over each other. In particular patients have a lifetime risk that the bowel can become~     kinked or twisted leading to complications such as bowel obstruction. Adhesions also make~     repeat abdominal operations more difficult. The adhesions have to be divided in order to~     separate the organs from each other and the abdominal wall. This can lead to blood loss and~     increases the risk of damage to these organs. Anti-adhesive agents have been created to~     reduce the severity of these adhesions, but there is little in the medical literature to~     evaluate their effectiveness, particularly in children. Biliary atresia is an obliterative~     obstruction of the bile ducts that occurs in infants. Initially they are treated by an~     abdominal operation called a Kasai portoenterostomy to restore bile flow from the liver to~     the intestines. However approximately 40% of these children will go on to require a liver~     transplant operation in the first two years of life. If CoSeal® Surgical Sealant is~     effective this could reduce the patients lifetime risk of complications from abdominal~     adhesions and also facilitate repeat abdominal operations for these children, in particular~     for those who go on to require a liver transplant.~   "
100168|NCT01745978|"~     The aim of the present study was to compare the efficacy and safety of the knob-tipped knife~     and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.~   "
100169|NCT01745965|"~     Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone~     receptors(ER and/or PR) breast cancer (HEr2+/HR+).~      A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic~     agent mertansine DM1)was tested with endocrine therapy and without against a standard arm~     with trastuzumab and endocrine therapy.~   "
100170|NCT01745952|"~     The investigators will treat patients with fully characterized refractory unifocal~     neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic~     stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the~     epileptogenic focus will reduce seizure frequency compared with sham rTMS.~   "
100171|NCT01745939|"~     The purpose of this study is to understand how different physical therapy interventions~     affect the use of certain abdominal muscles in patients with low back pain.~   "
100172|NCT01745926|"~     Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs~     in cardiac arrest patients and is fundamental for the neurological outcome and survival of~     these individuals. Unfortunately, the quality of CPR may be inadequate due largely to~     ineffective chest compressions resulting from rescuer fatigue and interruptions in~     compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund,~     Sweden), introduced in 2002, is the most extensively tested and applied automated~     alternative to manual CPR for in-hospital care of cardiac arrest patients and during~     ambulance transfer; the feasibility of application of this device in helicopter emergency~     medical service (HEMS) operations, however, has never been addressed. The objective of this~     project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2~     mechanical chest compression device to answer the question: What is the feasibility and~     efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR~     during HEMS rescue operations and transport?~   "
100173|NCT01745913|"~     The purpose of this study is compare the efficacy of haplo-cord transplant (investigational~     arm) with that of a more commonly used procedure in which only the cells contained in one or~     two umbilical cords are infused (standard arm).~      We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast~     engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus~     host disease, low frequency of delayed opportunistic infections, reduced transfusion~     requirements, shortened length of hospital stay and promising long term outcomes. We also~     hypothesize that umbilical cord blood selection can prioritize matching and better matched~     donors can be identified rapidly for most subjects.~   "
100174|NCT01745900|"~     Comparison of noninvasive glucose measurement performance versus standard invasive reference~     measurements.~   "
100175|NCT01745887|"~     This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled,~     parallel-group study designed to evaluate the safety and biological activity of two doses of~     EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye~     Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9~     centers located in the United States (US). Subjects will be enrolled in two groups or~     cohorts. The first enrollment group will consist of 33 subjects.~   "
100176|NCT01745874|"~     The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is~     superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of~     rectal cancer.~   "
100177|NCT01745861|"~     The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent~     reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this~     figure is more than double the highest previous estimated incidence. In the majority of~     patients the condition is mild, but about 25% of patients suffer a severe attack and between~     30 and 50% of these patients dies. The usual cause of death is multiple organ failure~     secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic~     inflammatory response syndrome (SIRS).~      Studies with omega-3 fish oil have shown to control inflammatory process and improve the~     outcome especially in hyperinflammatory conditions.~      This research will look at the effects of supplementing omega-3 fish oil to patients with~     severe acute pancreatitis (severe inflammation of the pancreas).~      Patients with severe acute pancreatitis will be prospectively and blindly randomised into~     either a study group who will receive (Lipidem, lipid emulsion contains essential fatty~     acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion~     contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical~     care will be provided to all patients as per the national management guidelines. Each~     patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit~     for discharge by their own medical team or for a maximum of SEVEN days.~      The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish~     oil could improve the clinical outcome in patients with severe acute pancreatitis.~   "
100178|NCT01745848|"~     Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease~     surrogate markers of bone metabolism and early cardiovascular disease in individuals with~     moderate to severe airflow obstruction and a chronic bronchitis phenotype.~   "
100182|NCT01745796|"~     Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its~     increasing resistance to antibiotics requires the development of new strategies for~     prevention and control, demanding a better understanding of the modes of transmission and~     evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation,~     the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination~     (endogenous, crossed transmission between patients, or environmental origin) of varying~     importance, mainly depending on the endemic situation of the place of study.~      The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of~     molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative~     techniques, the investigators wish to study the impact of the mode of contamination on the~     outcome of ICU patients, intubated and ventilated for more than 72 hours.~   "
100183|NCT01745783|"~     This is a phase I / II for the evaluation of the safety and feasibility of intravenous~     infusion of mesenchymal cells from autologous bone marrow in patients with Multiple~     Sclerosis.~      Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and~     safe and can be effective in treating patients suffering from multiple sclerosis.~   "
100184|NCT01745770|"~     The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID~     2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis~   "
100185|NCT01745757|"~     Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first-~     and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS~     in the individual studies currently reported. In Europe, EMEA has maintained its indication~     associated with weekly paclitaxel in first line metastatic breast cancer and more recently~     with capecitabine based on RIBBON 1 trial's results.~      The identification of patient subsets that receive the most clinical benefit would enable~     more specific treatment administration of bevacizumab and allow patients unlikely to benefit~     the opportunity to seek other treatment modalities. Unfortunately, despite efforts to~     identify patient subsets with a differential benefit from bevacizumab, no validated~     biomarkers have been defined.~      The Avastin cohort is a unique opportunity to investigate various biological and imaging~     parameters which could be related to clinical benefit of the combination of bevacizumab and~     weekly paclitaxel in first line MBC in a homogeneously treated population in French cancer~     centers. This trial will gather the expertise of several translational research platforms of~     different cancer centers from the UNICANCER consortium.~   "
100186|NCT01745744|"~     Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups~     controlled by two levels of dose to assess the safety and feasibility of the infusion of~     mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic~     patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.~   "
100187|NCT01745731|"~     This is a randomized controlled trial in which the safety and feasibility of cell therapy~     medicinal product shall be measured by comparing the variables of the response after~     treatment compared to baseline prior to implementation. Secondarily the results obtained are~     compared with each of the study groups.~      Patients will receive concomitant basic pharmacological treatment for maintaining liver~     function.~      All patients will be equally medically treated. The hypothetic test is to propose~     mononuclear cells from the bone marrow infused in the territory hepatic portal remaining~     segments (II and III) to be performed while contralateral portal embolization provides~     progenitor cells hepatic regenerative capacity that would shorten the time of liver~     regeneration and increase residual volume, facilitating the realization of an extended~     hepatectomy with greater assurance of maintaining proper residual function and adequate~     surgical margins.~   "
100188|NCT01745718|"~     The investigators will evaluate the accuracy of performing cytological imprints of targeted~     biopsies when diagnosing prostate cancer.~      It is useful to know whether the biopsy is cancer or not, in order to know when to stop~     sampling and when to continue.~      The strategy is used in other types of cancer, e.g lung, breast etc~   "
100189|NCT01745705|"~     Cervical spine manipulation (CSM) is utilized by many health care practitioners in the~     management of patients with neck pain and headache. How CSM works is not understood however,~     most researchers agree that there is likely a combination of mechanical, neurophysiological~     and placebo effects. This study will test for possible neurophysiological effects by~     examining for changes in a person's ability to reposition their head and neck in space, and~     maintain their balance following CSM.~   "
100190|NCT01745692|"~     Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood~     clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to~     restore the blood supply and limit the damage, resulting in an increased proportion of~     people making a recovery to independence after stroke. However, drug treatment only succeed~     in restoring blood flow in a minority of people with clots in the larger arteries (10-25%~     depending on the size of the blood vessel) and these people also have the most severe~     strokes and highest risk of death or dependence as a result of the stroke. Current best~     treatment is therefore least effective in the group with the most severe strokes. Devices~     that can be fed through the blood vessels to either remove or break up the blood clot in the~     brain vessels can open this type of large artery blockage. However, using these devices is a~     highly skilled procedure and it takes some time both to set up the necessary facilities~     (including anaesthetic, nurses and medical support) and to reach the blockage. The extra~     time that is required to use these devices may mean that brain tissue is already~     irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be~     harmed by opening the artery. There are no completed clinical trials comparing the outcome~     in people treated with standard stroke treatment and those treated with devices. PISTE is a~     randomised, controlled trial to test whether additional mechanical thrombectomy device~     treatment improves functional outcome in patients with large artery occlusion who are given~     IV thrombolytic drug treatment as standard care.~   "
100191|NCT01745679|"~     The aim of the study is to describe the concentrations of Ceftriaxone at the steady state,~     in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in~     this population. Additionally, we aimed to detect adverse effect, especially neurological~     trouble related to Ceftriaxone toxicity.~   "
100192|NCT01745666|"~     The aim of the study is to evaluate the best stress exam to unmask long QT in patient with~     KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.~   "
100197|NCT01745601|"~     The objective of this study was to confirm if two formulations of escitalopram tablets are~     bioequivalent.~      Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg~     escitalopram; Lundbeck). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, male adults between 18-50 years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
100198|NCT01745588|"~     The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces~     the number of myeloma cells in the bones, and to see what is the best way to use~     pomalidomide in patients with myeloma. To do this, the investigators want to compare two~     types of treatment using pomalidomde. This is a randomized trial which means that the~     decision as to which treatment the patient will receive will be made by a computer, much~     like flipping a coin.~      All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone~     (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell~     transplant followed by pomalidomide (Group 1). The other half of the patients will continue~     to receive ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2).~      At the end of the study, the two groups will be compared to see if there is a difference in~     disease outcome.~   "
100199|NCT01745575|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
100200|NCT01745562|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
100201|NCT01745549|"~     During the last years, even more little needles are used for the injection of sub cutaneous~     insulin, for the diabetes therapy.~      The aim of this study is to evaluate the non inferiority of a new needle, smaller than~     another needle, in terms of hematic levels od fructosamine, an indicator of glycemic~     control.~   "
100202|NCT01745536|"~     This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.~   "
100203|NCT01745523|"~     This study is aimed to evaluate the use of Hydroxypropyl Cellulose (HPC) as substitute for~     the traditional protein supplement (Synthetic Serum Substitute; SSS) and Trehalose as~     substitute for the most widely used sugar (Sucrose) in the vitrification solutions employed~     for oocyte vitrification.~   "
100204|NCT01745510|"~     -  The purpose of this study is to determine whether docosahexaenoic acid is effective in~          the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm~          neonates < 1500 g at birth who are starting enteral feeding.~        -  if NEC is prevented, this study will measure whether hospital stay is also reduced in~          neonates who receive Docosahexaenoic acid (DHA)~   "
100205|NCT01745497|"~     Autism Spectrum Disorders (ASD) are characterized by difficulties in language, social~     communication, and repetitive and restricted behaviors. ASD affects as many as 1 in 90-150~     children. Sleep issues/insomnia is very common in children with ASD (50-80%). Insomnia has a~     negative impact on both the developmental and behavioral function of the child and the~     quality of life for the family. Causes of insomnia in children with ASD are multifactorial~     and can be difficult to treat effectively. Low iron stores, as manifest by low serum~     ferritin levels, is also common in children with ASD. Both insomnia and low iron stores are~     associated with Restless Legs Syndrome (RLS) and Periodic Limb Movement of Sleep (PLMS).~     Children with ASD often have difficulty communicating symptoms or tolerating Polysomnography~     (Sleep Study). This makes establishing a diagnosis of RLS or PLMS very difficult in children~     with ASD.~   "
100206|NCT01745484|"~     Overall objective of the study is to compare the use of SPECT in radiotherapy treatment~     planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer~     patients~   "
100207|NCT01745471|"~     The purpose of this study is to collect data to help understand why some women develop~     Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.~   "
100208|NCT01745458|"~     This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts~     platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma~     biomarkers.~   "
100209|NCT01745445|"~     This trial aims to evaluate the efficacy and safety between radiotherapy alone and~     concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.~   "
100210|NCT01745432|"~     Adhesions are the most frequent complication of abdominopelvic surgery. They are internal~     scar tissues which form as a result of surgery which may abnormally join together what were~     once separate tissues and organs.~      This study will assess the safety and usability of anti-adhesion agent (gel) when used after~     laparoscopic surgery.~      The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse~     events in ADBLOCK and surgery only group) assessed at 28 days~   "
100234|NCT01745120|"~     This is a non-randomized, open label, multi-site, single-dose, Phase 1/2 study in up to 18~     subjects (including at least 3 adolescents between 12 and 17 years of age, inclusive) with~     beta-thalassemia major. The study will evaluate the safety and efficacy of autologous~     hematopoietic stem cell transplantation (HSCT) using LentiGlobin® BB305 Drug Product~     [autologous CD34+ hematopoietic stem cells transduced with LentiGlobin® BB305 Lentiviral~     Vector encoding the human β-A(T87Q)-globin gene].~   "
100211|NCT01745419|"~     Chronic obstructive pulmonary disease (COPD) is a common disease in smokers. COPD has a~     slowly deteriorating course, punctuated by exacerbations- acute events characterized by~     increasing shortness of breath and putrid sputum. Exacerbations of COPD may be precipitated~     by several factors, most commonly infections.~      Exacerbation frequency generally increases with declining lung function. However, some~     patients with COPD consistently experience a higher rate of exacerbations than others~     despite similar severity of COPD. This has led researchers to postulate the existence of a~     distinct subgroup of frequent exacerbators . Recent work has also brought attention to a~     subset of patients who experience remarkably few exacerbations despite significantly~     impaired lung function. Careful characterization of both of these extreme subgroups of COPD~     may offer additional insights into why certain patients are prone to frequent exacerbations~     while others remain relatively protected.~      Haptoglobin (Hp) is a protein produced predominately by the liver . In humans two types of~     genes for Hp exist (1 and 2) with possible combinations of these two genes- 1-1, 1-2, or~     2-2. The Hp 2 gene is believed to have arisen from the Hp 1 gene in human evolution.~     Subsequently the prevalence of the Hp 2 allele has spread throughout the world, probably as~     a result of its ability to provide a selective advantage against infectious disease. The Hp~     1-2 combination is a very common one. In most western countries, the prevalence of the Hp~     genotypes is 16% Hp 1-1, 36% Hp 2-2 and 48% Hp 2-1.~      The Hp gene form has been shown to be associated with disease. Specifically, Hp phenotypes~     have been found to affect propensity to atherosclerosis in Diabetic individuals. There have~     been several studies suggesting that the Hp 2-2 phenotype is associated with a protection~     against infectious complications.~      In view of the importance of respiratory infections on COPD exacerbations, and of the gained~     knowledge of Haptoglobin subtypes on propensity to infection, we propose to investigate~     whether Haptoglobin subtypes are in correlation with the frequent exacerbator phenotype of~     COPD. We postulate that, since people with Hp 1-1 are more prone to infection, the frequency~     of the Hp 1-1 phenotype will be higher in frequent exacerbators of COPD than in non-~     exacerbators.~      To test our hypothesis we propose to determine Hp phenotype in two groups of COPD patients:~     one with frequent exacerbations and one with no exacerbations, and compare the relative~     frequency of the 1-1 phenotype in the two groups.~   "
100212|NCT01745406|"~     When a patient is admitted to the ICU this often happens so suddenly that this can create a~     significant amount of stress and anxiety for family members for several reasons. Firstly,~     the family does not have a pre existing relationship with the ICU team. Secondly, the~     urgency of the situation and the technic it requires is often such that minimal information~     can be given to family members. And finally, as a result of the unpredictability of each~     patient's condition, it can be difficult to predict outcome for family members. Together,~     these factors compound the stress and anxiety of family members. This anxiety is natural and~     it is important for health caregivers to be able to offer the best support possible. A high~     quality communication provided by structured information given by physicians and nurses as~     well could improve support to the families and lead to greater satisfaction.~      Giving information to families during meetings is crucial at 3 moments: at the first day~     when the patient is admitted, at day 3, weekly and each time important news is given~     (surgery, deterioration in condition, end-of-life).~      The purpose of this project is to evaluate if the involvement of nurses during those~     meetings could improve quality in communication which is assessed by mixed methods. Families~     and healthcare workers satisfaction will be assessed by qualitative methodology. Family~     peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using~     validated scales.~      Training of healthcare workers will be done by role play. Information to the families is~     delivered using a framework for physicians and nurses. All the meetings of the study will be~     audited by a psychologist.~   "
100213|NCT01745393|"~     The study's primary aim is to test the hypothesis that an intervention integrating pediatric~     clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result~     in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and~     reported cigarettes exposed/day than a clinic-level quality improvement plus attention~     control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to~     CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate~     among parents.~   "
100214|NCT01745380|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for~     inducing pulpal anesthesia of the maxillary teeth in adults.~   "
100215|NCT01745367|"~     This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study~     for subjects with locally recurrent or metastatic triple negative breast cancer.~      Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or~     placebo and weekly paclitaxel.~      Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance~     score (0 vs 1) and line of treatment (first vs second).~      All subjects will be evaluated for progression free survival and overall survival as well as~     safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in~     study. This study will determine whether tivozanib hydrocholoride combined with weekly~     paclitaxel improves clinical outcomes in patients with triple negative breast cancer.~   "
100216|NCT01745354|"~     For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using~     cells from a healthy donor represents potentially curative treatment. In these individuals,~     cure is possible because transplantation of healthy donor immune cells can fight the~     lymphoma in the patient. The goal of this work is to test a strategy that activates the~     healthy donor immune cells so that they more effectively fight lymphoma and can result in an~     increased cure rate for these patients. Our group has previously studied CpG, an immune~     activating medication, in patients with lymphoma and demonstrated modest anti-tumor~     responses. We now have a more potent form of CpG which we intend to test to see if it will~     better activate the donor immune cells and result in shrinkage of tumor throughout the~     entire body, not just at the injected site.~   "
100217|NCT01745341|"~     The purpose of this study is to determine if apnea (the stopping of breathing) occurs in~     patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery~   "
100218|NCT01745328|"~     Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection~     (RUTI).~   "
100219|NCT01745315|"~     There are many instruments with different energy modalities or with different properties~     that are available for use in total laparoscopic hysterectomy. The aim of the present study~     is to compare three of these instruments that are present in our clinic - HALO PKS Cutting~     Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect~     to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative~     complications, return of gastrointestinal activity and hospitalization time.~   "
100220|NCT01745302|"~     The investigators performed a randomized, double-blind controlled, prospective study method~     on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the~     efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The~     investigators plan to involve 404 cases for observation in 3 years (202 cases for each~     group), expecting that integrated TCM combined with targeted therapy has a better efficacy~     on prolonging progression-free survival time, overall survival, improving QOL of patients~     than that of targeted therapy.~   "
100221|NCT01745289|"~     The LATTE study is an extension study to the now closed Arimidex, Tamoxifen Alone or in~     combination (ATAC) trail that took place 10 years ago. LATTE aims to collect long term~     follow-up information since the conclusion of ATAC, and for at least another 5 years,~     regarding: Additional efficacy data (first local recurrence, first distant recurrence),~     Additional safety data (ischaemic cardiac and cerebrovascular event, fractures), and Cause~     specific mortality and new primary cancers.~      The LATTE study will pick up where ATAC left off to follow a number of post-menopausal women~     with breast cancer who were randomised to receive either anastrozole or tamoxifen in the~     ATAC Trial and not known to have died or withdrawn consent before April 1st 2009. Since ATAC~     was a nationwide study, the women of LATTE will also reside and receive their follow-up care~     in various areas of the country. There will not be any vulnerable groups participating in~     this study.~      Patient interaction will consist on in person interviews at designated follow-up times~     and/or telephone interviews. Data will be collected at point of contact, whether that is in~     person at the clinic site or over the telephone. Telephone interviews will be completed in~     LATTE study offices. Topics of focus for data collection consists of: whether or not there~     is a suspected recurrence, new breast primary tumour, new other primary tumour, ischaemic~     cardiac event, cerebrovascular event, or a serious fracture. Since the follow-up questions~     are short in detail, respondent burden time should be less than 1 hour in most cases.~   "
100222|NCT01745276|"~     The purpose of this study is to evaluate the relative osseomechanical strength of a novel~     coated pin/screw in a clinical model.~   "
100223|NCT01745263|"~     The European population is aging rapidly which poses a challenge on the individual, the~     European societies, and health care systems. Among the most promising public health~     interventions that may extend healthy life expectancy at older age are vitamin D, marine~     omega-3 fatty acids and physical exercise. However, their individual and combined effects~     have yet to be confirmed in a clinical trial.~      The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The~     specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home~     exercise program will prevent disease at older age.~      To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are~     70 years and older, an age when chronic diseases increase substantially. The DO-HEALTH~     seniors will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin,~     Innsbruck and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple~     home exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period.~     This will allow to test the individual and the combined benefit of the interventions in the~     prevention of 5 primary endpoints: the risk of incident non-vertebral fractures; the risk of~     functional decline; the risk of blood pressure increase; the risk of cognitive decline; and~     the rate of any infection. Key secondary endpoints include risk of hip fracture, rate of~     falls, pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral~     health, quality of life, and life-expectancy.~      All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate~     the effect of the interventions at the cellular level of multi-organ function. DO-HEALTH~     will further evaluate reasons why or why not seniors adhere to the 3 interventions, and will~     assess their cost-benefit in a health economic model based on documented health care~     utilization and observed incidence of chronic disease.~      website DO-HEALTH: http://do-health.eu/wordpress/ website EC:~     http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do-health_en.html~   "
100224|NCT01745250|"~     The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and~     Juvederm Ultra smile~   "
100225|NCT01745237|"~     The primary objective of this study was to determine the ability of cardiac magnetic~     resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were~     to undergo CMR in addition to routine clinical evaluation.~   "
100226|NCT01745224|"~     This proof of concept study will be conducted to assess the aesthetic improvement in~     refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q~     Switched Nd: YAG Laser vs. Alex TriVantage~   "
100227|NCT01745211|"~     Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm~     Alexandrite laser.~   "
100228|NCT01745198|"~     In a retrospective analysis of data from 1100 patients, disease-delaying effects of~     Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current~     study is to expand the retrospective study dataset by prospectively collecting additional~     biomarker and imaging data.~   "
100229|NCT01745185|"~     This study is a prospective active comparator study to assess the immune response elicited~     by human recombinant agalsidase therapy in subjects who are switching from agalsidase alfa~     to agalsidase beta with Fabry disease. Fabry disease is an X-linked lysosomal storage~     disorder, due to deficient alpha-galactosidase A activity. The progressive accumulation of~     globotriaosylceramide (GL-3) in the lysosomes of the vascular endothelial cells of multiple~     organ systems like the kidneys, heart, skin, and brain, leads to a microvascular disease. In~     Fabry disease, nephropathy dominates and renal function impairment occurs as a result of~     accumulation of GL-3 in renal cells~   "
100230|NCT01745172|"~     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body~     removal in patients with high blood pressure (hypertension) resistant to medical treatment.~     Patients with high blood pressure are at significant risk of medical complications including~     stroke and heart disease. The principle research question is whether removal of the carotid~     body will lead to an improvement in the blood pressure of this patient group.~   "
100231|NCT01745159|"~     To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend~     remission time to relapse and reduce the incidence of disease exacerbation (DE) in~     paediatric patients over a period of 6 months.~   "
100232|NCT01745146|"~     The present study addresses problematic anger and irritability in community dwelling persons~     with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment~     approach called Anger Self-Management Training (ASMT), compared to a treatment offering~     supportive therapy focused on personal readjustment and education, the PRE (Personal~     Readjustment and Education). The project is a 3-center randomized controlled trial employing~     equivalent therapist time and therapeutic structure in the delivery of treatment options.~     The overall aim is to evaluate the relative response rate and correlates of treatment~     response for the ASMT as compared to the PRE.~   "
100233|NCT01745133|"~     The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam~     may help maintain the therapeutic benefit that is achieved with OLUX-E™ Foam in the~     treatment of moderate plaque psoriasis.~      OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation.~     SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by~     the FDA for treating plaque psoriasis.~   "
100235|NCT01745107|"~     The purpose of this study is to determine the efficacy of preventive intensity modulated~     radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous~     cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.~   "
100237|NCT01745081|"~     Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and~     intensive care settings. More recent data indicate that hypertonic saline may be as~     effective or more effective than mannitol for this purpose, with possible fewer side~     effects.~      This study compares both agents in favoring cerebral relaxation during elective~     supratentorial procedures for tumor resection.~      Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer~     side effects than 20% mannitol.~   "
100238|NCT01745068|"~     During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will~     experience at least one fracture due to bone fragility (FF). Evidence is growing regarding~     prevention programs' effectiveness to prevent falls, but prevention of fractures through~     fall prevention programs has enjoyed limited success. Falls prevention programs and~     post-fracture screening programs leading to pharmacological treatment are very different~     strategies, with a shared ultimate goal. Coordination between those who repair fractures and~     those who manage the patient to prevent the next fracture is critical. The overarching aim~     of this proposal is to generate evidence-based knowledge about the effectiveness and~     cost-effectiveness of an integrated FF prevention program, as well as a portrait of the~     barriers and facilitating factors for such programs. More specifically, the objectives are:~     1) to combine existing fall prevention and post-fracture management programs in the province~     of Quebec into integrated FF prevention programs; 2) to compare the performance of these~     integrated programs to control sites, using a pragmatic study design; 3) to identify~     barriers as well as factors that improve effectiveness across different implementation~     milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec~     regions where integrated FF prevention programs are neither adequately nor successfully~     implemented. Drawing upon the literature on integrated healthcare, fall and fracture~     prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent~     fracture by at least 30% in the population of interest. The proposed team is poised to~     develop new interdisciplinary collaborations among healthcare practitioners and decision~     makers involved in the prevention of FFs. The program is built upon existing healthcare and~     structures and programs and in turn, will truly measure the effectiveness of an integrated~     FF prevention program. The results will ultimately lead to improvements in the existing~     knowledge base, address policy-relevant and health systems problems, and assist in the~     design and implementation of FFs prevention programs.~   "
100239|NCT01745055|"~     This study was designed to estimate the effects of methotrexate (MTX) on the~     pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis~     (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term~     safety and tolerability of co-administration of CP-690,550 and MTX.~   "
100240|NCT01745042|"~     The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and~     symptomatic profiles in postmenopausal women.~   "
100241|NCT01745029|"~     The purpose of this study is to describe gastrointestinal (GI) motility in patients~     suffering from severe Ulcerative Colitis (UC) and to compare these results with similar~     results obtained in remission.~      The study is done with the use of Motilis 3D-Transit system which consists of a small~     electronic capsule ingested and detected by a receiver carried by the patient. Position and~     orientation of the capsule are interpreted by dedicated computer software and transit times,~     progression velocity and contraction frequencies can be revealed.~      The study is mainly descriptive and is designed to test and evaluate the usefulness of the~     Motilis 3D Transit system in UC patients and to tell investigators more about GI motility~     during and after severe inflammation.~      Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal~     canal as a whole during and after severe illness.~      The investigators expect to include 20 patients suffering from severe UC admitted to~     Hospital with the purpose of getting medical treatment. The investigators do not expect any~     drop out, but in case of drop out a new patient will be included.~   "
100242|NCT01745016|"~     Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle~     buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine~     the effectiveness of beta-alanine supplementation. The physical working capacity test has~     been used to show significant increases in physical working capacities following~     supplementation. The physical working capacity tests were originally developed by Moritani~     et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is~     hypothesized that beta-alanine will increase physical working capacity at heart rate~     threshold, thereby signifying a delay in fatigue.~   "
100243|NCT01745003|"~     The main goal of this Collaborative Proposal is to investigate biochemical, functional, and~     structural neuroimaging changes following non-invasive brain stimulation in patients with~     chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities~     which focus on central mechanisms provide modest relief for these patients raises the~     possibility that the cause for the chronicity of this debilitating disorder may lie within~     the brain itself. We propose that changes in the cortical milieu may result from prolonged~     experience of pain and suffering. Our previous results suggest changes in excitatory~     neurotransmitter levels, connectivity between multiple brain networks, and cortical~     thickness coincide within central neural loci related to pain perception and modulation in~     FM. Interestingly, modulation of cortical activity can be achieved noninvasively by a novel~     tool, transcranial direct current stimulation (tDCS), which has been reported to produce~     lasting therapeutic effects in chronic pain, especially FM. We propose to study the~     long-term effects of tDCS application on multiple levels of the central nervous system in FM~     patients. This project has significant clinical relevance and has the support of~     collaborators from University of Michigan and Harvard University~   "
100244|NCT01744990|"~     The aim of this study is to identify, based on standardized food provocation tests, which~     nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts~     (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators~     postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E~     level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of~     other food allergies or a history of a severe previous reaction~   "
100245|NCT01744977|"~     The purpose of the overall study is to improve medication use rates among veterans by~     looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve~     patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their~     medications based on how often they refilled their medications in the last 12 months.~      The investigators will test an innovative adherence packaging relative to usual care. The~     primary hypothesis is that veterans who receive the intervention will have greater~     improvement in their medication adherence as measured by pill refill at 6 and 12 months of~     follow up as compared to the control group.~   "
100246|NCT01744964|"~     The aims of this study were to assess the effects of the dopamine agonist apomorphine on~     experimental pain models in healthy subjects and to explore the possible association between~     these effects and a common polymorphism within the dopamine transporter gene.~   "
112133|NCT01588535|"~     This study is to assess the reliability and validity of the FAECC scale to evaluate pain~     associated with acute otitis media in children aged 2 months to 5 years.~   "
100247|NCT01744951|"~     This study seeks to pilot a manualized adoption-specific intervention aimed at providing a~     preventive intervention for families adopting children ages 5-14 years where family~     reunification has been terminated and the family is moving toward adoption or who have~     adopted children from foster care in the last three years. This work will fill a major gap~     in services to children and families and is developed to improve mental health and family~     functioning of children adopted from foster care, as well as decrease adoption disruptions.~     President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA),~     along with subsequent Congressional initiatives, have provided incentives to States and~     subsidies for adopting older children with a resultant increase in rates of adoption from~     foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The~     mean age at adoption from foster care is now 6 years old. These older children have~     histories of physical and sexual abuse, neglect, and multiple placements, all factors that~     predict behavior problems over time. To address this gap in our knowledge of providing care~     for this vulnerable group, we have developed a manualized adoption-specific intervention for~     families adopting children from foster care. Because adoptive children generally enter homes~     with stable, well-functioning parents, interventions may be particularly effective in~     helping the children adjust and their parents learn to understand and manage children with~     difficult past histories.~      The aim of this current pilot trial is to test this intervention designed to improve the~     outcomes for children adopted from foster care through a randomized trial. Our hypothesis is~     that this manualized adoption-specific intervention will be more effective than care as~     usual in improving child mental health and family functioning outcomes; specifically,~     families and children who have been randomized to the manualized adoption-specific~     intervention will show better outcomes on the post-treatment measures and the 3 month~     follow-up than on the pre-treatment measures than the care as usual families and children.~   "
100248|NCT01744938|"~     Patients with the lower malignant obstructive jaundice planned to do the~     pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without~     preoperative biliary drainage), both groups has the similar surgical morbidity, no~     statistics significance.~   "
100249|NCT01744925|"~     This study is designed to evaluate the safety and efficacy of icotinib at routine dose and~     higher dose as second-line treatment in non-small cell lung cancer patients with epidermal~     growth factor receptor of wild type.~   "
100250|NCT01744912|"~     The purpose of this study is to determine whether ublituximab in combination with~     lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies~     who have relapsed or are refractory after CD20 directed antibody therapy~   "
100251|NCT01744899|"~     The purpose of this study was to examine the effect of prolonged sitting duration and three~     different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve~     root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure~     under the ischial tuberosities during the three sitting postures were assessed and~     correlated with the SOL H-reflex amplitude.~   "
100252|NCT01744886|"~     One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has~     been discussed in multiple studies. Literature shows different ventilation strategies and~     possible hypoxemia has been attributed to several issues.~      Port-access cardiac surgical procedures (key hole surgery including mitral valve repair or~     prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a~     combination of these) require the use of OLV as well. Its effect on oxygen saturation has~     not been studied previously.~      The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and~     patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV~     during port-access in comparison to oxygen saturation throughout OLV during lateral~     decubitus thoracotomies.~   "
100253|NCT01744873|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult human subjects.~   "
100254|NCT01744860|"~     This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house~     methods used in molecular laboratories for the assessment of the BRAF mutation status in~     melanoma tumor samples. No patients will be enrolled in this study. Data will be collected~     for approximately 6 months.~   "
100255|NCT01744847|"~     In patients with pancreatic duct cannulation initially by chance, double guide wire~     technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the~     similar success rates. The incidence of post-procedure pancreatitis was similar in the two~     groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.~   "
100256|NCT01744834|"~     Overall goal of this study is to scrutinize the relation of learning behavior and related~     brain activity to the development of alcohol use disorder (AUD).~      The researchers aim is to characterise a representative sample (200 men at age 18) with~     regard to learning parameters and their respective neural correlates which are thought to be~     indicators for the risk to develop an alcohol use disorder.~      As part of a large multi-center study on alcohol dependency (in Dresden & Berlin, Germany)~     the researchers will characterize the sample and then prospectively assess alcohol~     consumption and development of AUDs over a period of three years.~      Among other hypotheses it is expected that increased activation of striatal and prefrontal~     brain regions by the Pavlovian-to-instrumental transfer process is related to increased risk~     of developing an AUD.~   "
100257|NCT01744821|"~     The purpose of this research is to study Vitamin D3 replacement for patients at high risk of~     developing ovarian, fallopian tube, or peritoneal cancer, and see if the Vitamin D3~     replacement may be able to prevent the cancer.~      This study is being done because in the United States ovarian cancer is the leading cause of~     death among women with gynecologic cancer. Women with BRCA mutations, a personal history of~     breast cancer, and a family history of breast and ovarian cancer are at high risk of~     developing ovarian, fallopian, and primary peritoneal cancer. Novel treatments other than~     surgery which can decrease the risk of developing ovarian, fallopian tube, and primary~     peritoneal cancer are important. Vitamin D has been shown to reduce the risk of developing~     bladder, breast, colon, endometrial, esophageal, gallbladder, gastric, lung, pancreatic,~     prostate, rectal, renal, vulvar and Hodgkin and non-Hodgkin lymphoma, and it may play a role~     in the prevention of ovarian cancer.~   "
100258|NCT01744808|"~     To investigate whether there is a food-effect with oral administration with EB-1020 as well~     as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.~   "
100259|NCT01744795|"~     Minimal invasive monitoring systems of central hemodynamics are gaining increasing~     popularity. The present study investigates the precision of the esophageal doppler (CardioQ)~     derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC~     TD) for measuring CO during steady state and with induced hemodynamic changes in patients~     scheduled for elective cardiac surgery.~   "
100507|NCT01741571|"~     Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques~     have not been well studied. The investigators will conduct a randomized study comparing the~     diagnostic yield and specimen quality of EBUS-FNA performed with and without suction~     applied.~   "
100260|NCT01744782|"~     This is a long-term, open-label study of the safety, tolerability and effectiveness of RP103~     in cystinosis patients who are naïve to any form of cysteamine treatment. Subjects will~     receive RP103 treatment for at least 12 months. US subjects will transition to the~     commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study~     participation and upon approval by the Brazilian regulatory authorities, subjects will be~     eligible to transition to a post study drug supply program, and continue to receive the drug~     at no personal cost.~   "
100261|NCT01744769|"~     1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant~          number of them experience severe hypothyroidism in preparation for radioactive iodine~          (RAI) therapy after total thyroidectomy.~        2. Because the function of thyroid hormone is closely linked with lipid and glucose~          metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy~          may induce the changes of metabolic parameters.~        3. We investigate the effects of thyroid hormone withdrawal on metabolic and~          cardiovascular parameters during radioactive iodine therapy in differentiated thyroid~          cancer.~   "
100262|NCT01744756|"~     A study to research whether subconjunctival bevacizumab injection may potentially suppress~     neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.~   "
100263|NCT01744743|"~     To assess the effect of universal preconception hypothyroidism for maternal pregnancy~     outcome, and 0-3yrs offspring neurocognitive ability and IQ score.~   "
100264|NCT01744730|"~     The purpose of this study is to better understand how clindamycin works in children who fall~     in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height).~     The results of the study will help better understand if children in higher BMI ranges~     process the medication differently and whether dosing should be adjusted in these children.~   "
100265|NCT01744717|"~     Pain is an unpleasant and important stress factor, and a potentially harmful experience for~     critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t~     report their own pain. Behavioral indicators have been proved as useful and reliable for~     detecting and measuring pain in these patients, and have been the basis for constructing~     scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care~     Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .~      The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in~     Spain, showing good validity and reliability.~      The objective of this Spanish multicentre study is to test the validity and reliability of~     the ESCID scale in a large sample of critically ill patients with medical and postsurgical~     pathology for the detection and measurement of pain.~   "
100266|NCT01744704|"~     The primary objective of this study is to assess the safety and tolerability of single and~     multiple ascending doses of rhNGF when administered as eye drops in healthy subjects.~   "
100267|NCT01744691|"~     An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase~     Inhibitor PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic Lymphocytic~     Leukemia or Small Lymphocytic Lymphoma with 17p Deletion~   "
100268|NCT01744678|"~     The purpose of this study is to validate the acceptability, operational feasibility and~     efficacy of a combined fatigue countermeasure comprised of shorter-wavelength light and~     exercise during operational Orbit 1 night shifts to improve alertness and performance of~     flight mission controllers.~      Specifically, the investigators will:~        1. Feasibility. Test the feasibility of developing a break room containing fatigue~          countermeasures (shorter-wavelength light and exercise equipment) to be used by flight~          mission controllers during Orbit 1 night shifts, and the feasibility to schedule~          regular breaks during the Orbit 1 shift so that flight mission controllers have the~          opportunity to use the fatigue countermeasures break room.~        2. Acceptability. Test the acceptability of the use of the fatigue countermeasures break~          room evaluating when and how the room is used by flight mission controllers, as~          measured on End-of-Shift Productivity Questionnaire.~        3. Test the hypothesis that alertness and performance will be impaired in flight mission~          controllers during Orbit 1 operational night shifts as compared to flight mission~          controllers working a non-console day shift.~        4. Test the hypothesis that alertness and performance of flight mission controllers who~          exercise and are exposed to shorter wavelength light during the Orbit 1 night shift~          will be significantly more alert and have better mood, performance (e.g., less PVT~          lapses, increased productivity) than those same mission controllers working Orbit 1~          night shifts without exposure to the shorter wavelength light and exercise.~        5. Test the acceptability, operational feasibility and efficacy of implementing an~          anonymous sleep disorders screening for flight controllers, evaluated by number of~          visitors to the screening web site and the number of completed assessments.~   "
100269|NCT01744665|"~     To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in~     patients who achieve MR4.5~   "
100270|NCT01744652|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of dasatinib and crizotinib that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~      Dasatinib is designed to block certain proteins from causing cancer cells to grow out of~     control. This may cause the cancer cells to die.~      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause~     the cancer cells to die.~   "
100271|NCT01744639|"~     Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional~     assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric~     Hepatic Encephalopathy Score and Critical Flicker Frequency.~   "
100272|NCT01744626|"~     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine~     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated~     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the~     combination of CC-292 and Rituximab in subjects with CLL.~   "
100273|NCT01744613|"~     Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular~     procedures. The clinical significance of an inadequate response to clopidogrel following~     percutaneous coronary interventions has been recently recognized.This study was designed to~     investigate platelet responsiveness to Clopidogrel following endovascular therapy of~     peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine~     the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing~     outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel~     antiplatelet therapy.~   "
100274|NCT01744600|"~     The study is a cluster randomised control trial, which aims to investigate the effectiveness~     of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in~     older adults with dementia. In particular, the study aims to identify the main components of~     music therapy that are key in achieving this. The study will also explore carers'~     perceptions of music therapy, and investigate whether carers become more attentive to~     patients' needs and more able to manage patients' BPSD as a result of the music therapy~     programme.~   "
100275|NCT01744587|"~     The purpose of this study is to investigate the EBV reactivation rate in post-radiation and~     remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the~     observational correlation between EBV reactivation and clinical outcome.~   "
100277|NCT01744561|"~     Physical activity and exercise have become an accepted and valued component of Cystic~     Fibrosis care. Regular physical activity and exercise can slow the rate of decline of~     pulmonary function, improve physical fitness, and enhance quality of life. However,~     motivating people to be more active is challenging. Supervised exercise programs are~     expensive and labor intensive, and adherence falls off significantly once supervision ends.~     Unsupervised or partially supervised programs are less costly and more flexible, but~     compliance can be more problematic. The primary objective of this study is to evaluate the~     effects of a 12-months partially supervised exercise intervention along with regular~     motivation on forced expiratory volume in 1 second (FEV1) in a large international group of~     cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as~     well as levels of anxiety and depression, and control of blood sugar. A total of 292~     patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be~     recruited. Following baseline assessments (2 visits) patients will be randomized into an~     intervention and a control group. Thereafter, they will be seen every 3 months for~     assessments in their centre for one year (4 follow-up visits). Along with individual~     counseling to increase vigorous physical activity by at least 3 hours per week on each~     clinic visit, the intervention group will document daily exercise and inactivity time and~     will receive a step counter and they will record their progress with a web-based program.~     They will also receive monthly phone calls from the study staff. After 6 months, they will~     continue with the step counter and web-based program for a further 6 months. The control~     group will receive access to this intervention after 12 months of standardized care. Should~     this relatively simple program prove successful, this will be made available on a wider~     scale internationally.~   "
100278|NCT01744548|"~     This study aims to evaluate the feasibility, acceptability and efficacy of transdiagnostic~     Cognitive Behavioural Therapy (tCBT) in comparison to delayed-treatment for depression and~     anxiety in older people. CBT is a form of 'talking therapy' that has been recommended by the~     National Institute of Clinical Excellence for the treatment of mood disorders. While~     traditional disorder-specific CBT has been found to be effective at alleviating individual~     mood disorders, it may be less effective when multiple mood disorders are present (i.e. when~     there is psychological comorbidity). tCBT is a form of CBT that targets cognitive and~     behavioural processes common to a range of mood disorders. Consequently, it may be better~     placed to address comorbidity than traditional CBT, both in terms of clinical and~     cost-effectiveness.~      There is growing evidence that tCBT has beneficial effects on both depression and anxiety in~     working-age people. However, the potential benefits of this approach have not yet been~     examined in older people (in whom psychological comorbidity is a frequent problem).~     Therefore, this study will aim to recruit 22 older people who are experiencing symptoms of~     depression and anxiety from community mental health teams within the South London and~     Maudsley National Health Service Trust. Participants will be randomly allocated to receive~     either tCBT plus treatment-as-usual (TAU) or 7-week delayed tCBT plus TAU. tCBT will be~     delivered on an individual basis in 12 sessions, each lasting 1 hour, over 14 weeks. It will~     be delivered in outpatient clinics or within the participants residence, depending on~     mobility issues. A number of outcome measures will be used to evaluate the feasibility,~     acceptability and efficacy of tCBT, including ratings on mood questionnaires, rates of~     dropout and reasons for dropout. Outcome measures will be collected before the tCBT~     intervention starts (week 0/baseline), midway through the intervention (after the 6th tCBT~     session/week 7), at the end of the intervention (after the final tCBT session/week 14) and~     at 7-week follow-up (week 21) .~      The main hypotheses are:~      i. It will be feasible to adapt and establish a tCBT intervention for older people with~     comorbid depressive and anxiety disorders.~      ii. The tCBT intervention will be acceptable to older people with comorbid depressive and~     anxiety disorders.~      iii. The tCBT intervention will significantly reduce depression and anxiety symptoms~     relative to a delayed-treatment control condition.~   "
100279|NCT01744535|"~     The aim of this study is to implement an exploratory pilot trial of My Meal Mate (MMM), a~     smartphone application developed to facilitate weight loss, assessing its feasibility and~     acceptability. Overweight and obese adults will be recruited from large employers within the~     local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision~     based on randomizing 45 people to each arm. Participants will be randomized to one of three~     groups. The researchers have developed a smartphone application for weight loss called My~     Meal Mate (MMM) which incorporates a large branded food and drink database. MMM was~     developed using focus group data collected from potential system users and by benchmarking~     with similar commercially available diet tracking applications. One group will receive a~     smartphone with the MMM app downloaded on it, one group will receive access to an online~     food diary and one group will be given a paper food diary. Participants will be asked to set~     a goal for weight loss and self-monitor their food intake and activity using their allocated~     study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and~     at 6 months. Feasibility and acceptability outcomes will be assessed.~   "
100280|NCT01744522|"~     The purpose of this study is to investigate, whether leech therapy for the treatment of~     postherpetic pain improves pain and sensory function.~      Therefore 20 patients with PHN undergoing leech therapy at the investigators outpatient~     clinic will be included in this observational trial.~   "
100281|NCT01744509|"~     In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2~     (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program~     (primary outcome measure).~      Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography~     and optical colonoscopy. In this study the reference standard is represented by the~     segmental unblinded colonoscopy (the unblinding is based on results of both capsule~     endoscopy and Ct colonography) The investigators also evaluated the tolerability of PCC2 as~     compared to optical colonoscopy (OC) and CT-colonography (CTC).~   "
100282|NCT01744496|"~     This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic~     Pain associated with Parkinson's Disease among patients with advanced stages of the disease.~   "
100283|NCT01744483|"~     Researchers are looking at three different types of breathing tubes to see if any of them~     are better at preventing pneumonia than the others. Two of the tubes have design features to~     prevent leakage of fluids from the mouth and throat into the lungs. This is importance,~     since leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube~     is the standard tube used at most hospitals.~      The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs~     will reduce the risk of developing pneumonia, compared to the standard tube. The study will~     also look at the safety of the modified breathing tubes, compared to the standard tube.~      This study is a small, pilot study that will determine if it is possible to perform a~     larger study that will provide more certain results.~   "
100284|NCT01744470|"~     This prospective, interventional, open label, randomized, multicenter study was designed to~     determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after~     transplantation. Randomized patients are to be stable with their tacrolimus daily dose~     required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility~     assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction~     of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their~     usual dose. The benefit/risk ratio will include the assessment of renal function,~     histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data~     (metabolic and infectious diseases).~   "
100297|NCT01744301|"~     The purpose of this study is~        1. to estimate the incidence of seizure in the general population and stratified by~          epilepsy status~        2. To estimate the relative risk of seizure associated with use of proton pump inhibitors~          and histamine 2 receptor antagonist and stratified by epilepsy status~   "
100285|NCT01744457|"~     Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged~     45 and older. Although several clinical tests for the diagnosis and monitoring of DES are~     available, currently no gold standard for the assessment of DES exists. It has, however,~     been hypothesized that the assessment of tear film osmolarity may be a new and promising~     approach of an objective and non-invasive method for diagnosis and monitoring of treatment~     success.~      Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA)~     for the assessment of tear film osmolarity has been introduced. This instrument allows for~     the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data~     about reproducibility are yet available. Consequently, the current study sets out to~     investigate the short time reproducibility of tear film osmolarity measurements using the~     TearLab® instrument.~   "
100286|NCT01744444|"~     Different treatment trials have been published in acquired nystagmus in the last decade;~     gabapentin and memantine have been found to be efficient in treating pendular nystagmus in~     Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude,~     frequency and on visual acuity. None of the trials measured a functional visual score or~     oscillopsia score.~      The aim of our study is to evaluate the effect of gabapentin and memantine on the mean~     velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual~     acuity and vision-specific health-related quality of life score, in 10 patients with~     multiple sclerosis. The primary object is to find out the best variable to evaluate the~     efficiency of nystagmus treatment and the secondary, to compare the efficiency of both~     gabapentin and memantine in a common population of patients.~   "
100287|NCT01744431|"~     Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill~     patients~      Traditional coagulation tests do not assess the whole coagulation system. Thrombin~     generation assays measure the ability of plasma sample to generate thrombin following in~     vitro activation of coagulation. In contrast to the classical clotting assays, thrombin~     generation reflects and integrates all pro and anticoagulant reactions that regulate the~     formation and inhibition of thrombin.~      The aim of our study is to investigate whether thrombin generation would be able to predict~     a hypercoagulable state in acute ill patients admitted in the internal medical departments~     and how it correlates with the Padua prediction score, a score that could assists the risk~     for venous thromboembolism in hospitalized medical patients.~      In total 300 patients are planned for inclusion in this trial. After signing an informed~     consent a blood sample will be obtained from each participant. We will measure the thrombin~     generation over time in plasma assessed by the calibrated automated thrombogram (CAT).~   "
100288|NCT01744418|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in~     the creation of vascular access for dialysis.~   "
100289|NCT01744405|"~     The investigators propose to study the transfer of nifurtimox into breastmilk of lactating~     women who receive the drug for the treatment of Chagas disease.~      Breastmilk and blood samples will be obtained from these patients at pre-specified times~     after they take the clinically indicated medication, and the concentrations in both matrices~     will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into~     breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by~     these women to nifurtimox. This study will help clarify safety of continuing breastfeeding~     while receiving treatment with nifurtimox for Chagas disease.~   "
100290|NCT01744392|"~     The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25~     individuals among veterans with cardiovascular disease risk factors including Hypertension~     (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the~     hospital-based primary care clinics associated with Durham VAMC. The investigators will~     examine veteran's perception and ease of using an innovative tool to help improve medication~     adherence to cardiovascular medications. This study aims to focus on patients with multiple~     chronic conditions and their caregivers to address 1) appropriate use of medications~     2)maximize patient self-care and care by families and other caregivers 3) make available a~     tool for medication management 4) managing complex regimens, and 5) addressing health~     literacy.~   "
100291|NCT01744379|"~     This study will explore the safety, tolerability, and serum uric acid lowering effect of~     lesinurad in healthy Japanese males to allow comparison with the Western population.~   "
100292|NCT01744366|"~     One month degarelix/comparator treatment for prostate cancer in Chinese population~   "
100293|NCT01744353|"~     The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which~     consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and~     abraxane. Each of these drugs are currently used in pancreatic cancer.~      The experimental part of the study is combining these drugs together in FOLFOX-A.~   "
100294|NCT01744340|"~     The purpose of this study is to determine if the full dose of eribulin mesylate can be~     safely given with the full dose of cetuximab. The activity of the combination of eribulin~     mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be~     assessed.~   "
100295|NCT01744327|"~     TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance~     of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the~     importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal~     molecules in psoriasis is important because the development of new drugs directed against~     relevant signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious~     treatment principle. However, despite the dramatic progress in therapeutic options during~     the last decade, there is still a fraction of patients that are insufficiently treated with~     the currently available therapies. TL1A has been claimed to be the next important target for~     development of biologics in the field of chronic inflammation.~   "
100296|NCT01744314|"~     Patients who present to our institution with a traumatic injury to their elbow who need~     operative management will be randomized to one of two groups; a treatment arm and a control~     arm. The treatment arm will receive a three-week postoperative course of indomethacin while~     the control group will not. We will follow both groups to assess whether or not indomethacin~     prophylaxis affects the rate of heterotopic ossification.~   "
100298|NCT01744288|"~     Study to see if platelet transfusion stop or lessen the effect of the drug on platelets~   "
100300|NCT01744262|"~     Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the~     past decade and has widely replaced conventional open prostatectomy in many institutions due~     to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay.~     However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation,~     which leads to increased intraocular pressure (IOP). In particular, robot-assisted~     laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position~     and often prolonged insufflation times, which is known to effect the increase in IOP during~     surgery and may result in ophthalmic complications such as postoperative vision loss (POVL).~     The majority of patients undergoing RALRP is old aged and often present with comorbidities.~     Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient~     vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having~     undiagnosed glaucoma is also increased, and therefore methods to prevent such complications~     are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have~     been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous~     humour outflow to some extent. Among these agents, propofol has been reported to be more~     effective than other inhalational anesthetics in decreasing IOP. The goal of this~     prospective, randomized controlled trial is to compare the effect of propofol and~     sevoflurane on IOP in patients undergoing RALRP in the steep Trendelenburg position with~     carbon dioxide pneumoperitoneum.~   "
100301|NCT01744249|"~     The purpose of this study is to determine if Axitinib prolongs progression-free survival of~     patients with advanced well differentiated neuroendocrine carcinomas of non-pancreatic~     origin compared to placebo.~   "
100302|NCT01744236|"~     The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1~     receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal~     systems in patients with Type 2 Diabetes Mellitus.~   "
100303|NCT01744223|"~     This study will evaluate patients with blood cell cancers who are going to have an~     allogeneic (donor) blood stem cell transplant from a partially matched relative. The~     research study will test whether immune cells, called T cells, which come from the donor~     relative and are specially grown in the laboratory and then given back to the patient along~     with the stem cell transplant (T cell addback), can help the immune system recover faster~     after the transplant. As a safety measure, these T cells have been programmed with a~     self-destruct switch so that if, after they have been given to the patient, the T cells~     start to react against the tissues (called graft versus host disease, GVHD), the T cells~     can be destroyed.~   "
100304|NCT01744210|"~     Historically, transthoracic Doppler echocardiography has been unable to provide~     interpretable data of blood flow within the lung parenchyma because of air attenuation of~     Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek~     Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary~     blood flow (PPBF) signals. The ability to non-invasively collect information regarding the~     pulmonary aspect of the cardio-pulmonary system may provide valuable information and new~     insights into the structural and functional characteristics of the lung parenchyma and~     vasculature in health and disease states.~   "
100305|NCT01744197|"~     Synera, which is a heated topical patch containing both lidocaine and tetracaine, is~     intended to reduce the pain associated with venipuncture and superficial dermatologic~     procedures by numbing the skin. This study will test the effectiveness of the Synera~     lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia~     in adult oncology patients undergoing venipuncture as part of their care, for treatment or~     diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study~     hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be~     observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a~     0-10 VAS~   "
100306|NCT01744184|"~     This study aims to determine whether Entonox (gas and air) is at least as good as~     intravenous midazolam in providing analgesia and sedation during gastroscopy. Entonox is~     used as an adjunct in lower gastrointestinal procedures but is not routinely used in~     gastroscopy, and there is only one similar published study to date, which was performed in~     children. The main advantage of Entonox over midazolam is the quick recovery time following~     withdrawal of the agent, which enables patients to return to independent normal life. The~     investigators would like to be able to offer Entonox to patients as an option for sedation~     during gastroscopy, this study is being conducted to determine if it is a safe and feasible~     option.~   "
100307|NCT01744171|"~     This phase I trial studies the side effects and best dose of vaccine therapy in treating~     patients with stage III-IV melanoma that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or~     antigens may help the body build an effective immune response to kill tumor cells.~   "
100308|NCT01744158|"~     Abnormal limb and trunk movements are seen in many children with cerebral palsy. Recognizing~     the difference between types of these movements is not well understood. This study aims to~     describe how common are these movements in children recruited from a population-based sample~     of children identified on a cerebral palsy register, and to explore associations with motor~     abilities. It is hoped this will lead to improved understanding and recognition of movement~     disorders in CP, to allow clinicians to choose appropriate treatments. We hypothesise that~     the underlying prevalence of dyskinesia is higher than that previously identified through~     conventional motor descriptions in cerebral palsy populations in Australia, and may approach~     20%.~   "
100309|NCT01744145|"~     The mortality rate and quality of life is effected in patients with pneumonia, especially in~     the older population.~      The end point of this study is to improve quality of life by and interventional exercise and~     education. Patients will be randomized at admission and enrolled into the study. They will~     be assessed with various performance and quality of life indicators before, during and after~     the study, and exercise tolerance will be assessed throughout and after.~   "
100378|NCT01743248|"~     The surgery of a vestibular schwannoma induces balance disorders which have a an impact on~     the patient's daily life and disrupt their quality of life.~      But the balance disorders don't seem to be the only ones factors that impaired the patient's~     quality of life. It has been alrealdy shown that emotional and psychological factors are~     also related to patient's quality of life.~      This study evaluates the relationship between the balance control compensation and these~     factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.~   "
100310|NCT01744132|"~     The goal of this project is to implement a Collaborative Translational Research Center (TRC)~     Network Study which aims to assure optimal two-way communication between ophthalmologists~     and their patients' primary care physicians (PCP). The Collaborative TRC Network Study will~     have 2 objectives:~        -  To design and develop common research protocols to develop a 4-year retrospective~          database (2007-2010) that compiles electronic billing and medical chart information~          that can be used to study individual-level, clinical-level and system-level factors~          that impact access to and quality of vision care;~        -  To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary~          measureable quality indicator, and its relationship to the patients' demographics,~          ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other~          ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP)~          communication.~      By enhancing communication and strengthening the clinical information exchanged between PCPs~     and eye care professionals, this Collaborative TRC Network study will help to overcome~     barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.~   "
100311|NCT01744119|"~     The purpose of this observational Post-Market Surveillance Registry is to gather post-market~     data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the~     repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients~     suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24,~     36, 48 and 60 months post-implantation.~   "
100312|NCT01744106|"~     This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in~     children for the temporary relief of nasal congestion due to the common cold, an indication~     described under 21 CFR 341.80(b)(1).~   "
100313|NCT01744093|"~     In the context of improved survival from HIV infection itself, chronic obstructive pulmonary~     disease (COPD); a form of lung disease that includes emphysema, which makes breathing~     difficult) is emerging as an important cause of morbidity and perhaps ultimately mortality~     in this population. HIV-infected patients are at increased risk of chronic obstructive~     pulmonary disease, likely due to multiple factors, including an increased presence of~     smoking, chronic inflammation and progression of immunodeficiency, oxidant stress (excessive~     levels of natural chemicals called oxidants and free radicals that can damage tissue), and~     respiratory infections. While natural history data on COPD are limited in the era of potent~     antiretroviral therapy, earlier data suggest that the course of emphysema may be accelerated~     in this population. Our preliminary data suggest that several matrix metalloproteinases~     (MMPs) derived from alveolar macrophages (a type of immune cell found in the lungs) have an~     increased cellular response in HIV-infected smokers, which could contribute to accelerated~     emphysema. Matrix metalloproteinases are enzymes that break down the structural support of~     tissues, including the airways in the lung.~      Based on these observations, the investigators hypothesize that pharmacologic inhibition of~     matrix metalloproteinases by doxycycline will favorably modify the natural history of~     chronic obstructive pulmonary disease in HIV-infected patients. To test this hypothesis, the~     investigators propose conducting a proof of concept pilot study as a prelude to a possible~     phase II randomized, placebo-controlled trial (testing safety and efficacy in a larger~     population controlled with a sugar pill) of doxycycline for COPD in HIV-infected patients~     should the proof of concept be successful. Our research team is lead by a~     pulmonologist/researcher with expertise in HIV-associated COPD and an infectious diseases~     specialist/clinical trials expert.~   "
100314|NCT01744080|"~     The purpose of this prospective randomized controlled trial is to compare post-operative~     outcome between participants undergoing expedited surgery compared to those proceeding~     through a 'typical' wait time process. A secondary purpose is to evaluate the progression of~     rotator cuff tear size from the time of initial consult to the time of surgery.~   "
100315|NCT01744067|"~     Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary~     supplements containing omega-3 fatty acids are also commercially available. Some studies~     have described beneficial effects from omega-3 fatty acids, among them are~     anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive~     and lipid-modulating effects. Other studies have not confirmed these findings. This study~     will investigate the effects of omega-3 fatty acids on renal function and cardiovascular~     risk markers in renal transplant recipients.~   "
100316|NCT01744054|"~     The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a~     useful tool in individualizing patient care after the radioembolization procedure. The~     information from a PET/MR or PET/CT scan would allow for early evaluation of the technical~     success of the procedure.~   "
100317|NCT01744041|"~     Perinatal depression is a major public health problem, affecting 15% of women during~     pregnancy through the postpartum period, with adverse consequences for the mother, the~     fetus, the infant, and the family. Despite increasing evidence of the importance of this~     critical risk interval, little research has investigated the effects of depression treatment~     during pregnancy on infant outcomes. The purpose of this study is to test the feasibility,~     acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the~     mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with~     the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad~     will be better than treatment as usual in reducing depressive symptoms, improving~     psychosocial functioning,increasing parenting self-efficacy, improving infant emotional~     development, and enhancing mother-infant relationship quality.~   "
100318|NCT01744028|"~     The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system~     using a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in~     preventing hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations~     in a COPD population at high risk of exacerbation, compared to those managed by usual care.~   "
100319|NCT01744015|"~     1. (Primary) To compare the effectiveness of a patient guided choice of care using a~          patient decision support tool to clinical guided care within a novel care process for~          non-specific low back pain.~           (We hypothesize that the patient guided choice model will demonstrate significant~          improvements when compared to the clinician guided care approach)~        2. (Secondary) To qualitatively investigate which components of the patient choice~          educational methods were most effective for informed decision making among patients who~          participate in the patient guided choice of care approach (We hypothesize that dialogue~          method of patient guided choice will be identified as most useful)~   "
100320|NCT01744002|"~     The objective of this study is to investigate whether treatment directed at the neck and~     shoulder is more beneficial than treatment directed solely at the shoulder; for patients~     with shoulder impingement syndrome.~      (The hypothesis is that patients who receive neck mobilization will improve at a more~     significant rate than those who do not receive neck mobilization)~   "
101362|NCT01730352|"~     The purpose of this study is to determine whether eradication of Helicobacter pylori~     infection is effective in the improvement of platelet counts in children and adolescents~     with chronic ITP.~   "
100321|NCT01743989|"~     This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation~     treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months~     after starting the Treatment-Free Remission (TFR) phase of the study.~      Rationale:~      CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment,~     and who have failed to achieve the molecular response threshold for treatment cessation~     (≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal~     duration of consolidation treatment with nilotinib to ensure the highest rate of patients~     remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore~     aims to assess the potential impact of a longer duration of consolidation treatment with~     nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months~     of treatment-free remission.~   "
100322|NCT01743976|"~     Based on laboratory studies, donepezil will improve pain relief more than placebo in~     patients with chronic neuropathic pain who are currently taking gabapentin or pregabalin.~   "
100323|NCT01743963|"~     Using glucocorticoid induced diabetes (GID) we will conduct a small feasibility randomized~     intervention trial to improve GID management for veterans who are prescribed chronic~     glucocorticoids. Approximately 20 primary care providers (caring for approximately 100~     veterans on chronic steroids) will receive decisional support (automatically-derived orders~     for hemoglobin A1C, to be co-signed by providers). Approximately 20 providers (caring for~     100 veterans) who did not receive decisional support will serve as the control population.~     We will measure the time from randomization until the provider signs an order for hemoglobin~     A1C for both groups. The trial will be conducted at the VA's Eastern Colorado Health Care~     System (ECHCS) and will last approximately 6 months. After the completion of the trial for~     each provider, we will conduct a brief interview and survey of the participating providers~     to assess the acceptability of decisional support interventions to manage GID [protocol,~     page 1-2]. No patient data (PHI) will be collected by the providers.~   "
100324|NCT01743950|"~     To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27~     fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until~     time of progression in patients with recurrent high grade gliomas (grade III and grade IV).~     Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior~     exposure to bevacizumab.~   "
100325|NCT01743937|"~     Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary~     artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial~     infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a~     thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among~     patients with acute coronary syndromes (with or without ST-segment elevation) and those~     receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine,~     prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing~     percutaneous coronary intervention. Although prasugrel significantly reduced recurrent~     myocardial infarction, bleeding rates were increased and no improvement in cardiac or~     all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial~     demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over~     clopidogrel, an endpoint not previously met by any other antiplatelet agent against an~     active comparator. Based on the reproducible adverse events seen in the DISPERSE,~     DISPERSE-2, and PLATO trials, an adenosine-mediated effect of ticagrelor is proposed.~      Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces~     pharmacologic ischemic preconditioning, an undescribed potential off-label property of~     ticagrelor that could represent a plausible mechanism for its effects on cardiovascular~     mortality.~   "
100326|NCT01743924|"~     The aim of this study was to determine the absorption of isothiocyanates (ITC) after~     ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary~     biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate~     of these ITC was studied comparing to the uncooked vegetable.~   "
100327|NCT01743911|"~     Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In~     addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has~     been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic~     function in hypertensive rats, despite any difference in blood pressure levels. Also, left~     ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients.~     However, it is unknown if these effects exists in humans with resistant hypertension.~     Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil)~     for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.~   "
100328|NCT01743898|"~     The ability to explain bleeding or clotting complications in patients treated with~     rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests~     perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of~     coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding~     abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic~     reference range for peak and trough coagulation tests in patients taking FDA approved doses~     of rivaroxaban and to determine which tests may be most clinically useful for monitoring~     rivaroxaban.~   "
100329|NCT01743885|"~     There is no effective treatment for hemangioma regardless of immediate severity. That is in~     this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of~     proliferation of several months (very scary for parents) and regression over several years.~     The natural history is peppered with local complications (ulcers) and aesthetic and~     psychological sequelae (sometimes major for the child and the family). The effects of~     acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by~     two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and~     propranolol have been used for many years for the treatment of hypertension and congenital~     heart disease, including infants, with few side effects. The effects of acebutolol and~     propranolol were immediately visible with reduced volume and skin whitening of the~     hemangioma. In a preliminary study, acebutolol was administered to 20 patients in~     Montpellier with big regression of hemangiomas. The aim of the study was to compare the~     clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the~     proliferative phase of infantile hemangioma in infants.~   "
113056|NCT01576367|"~     This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS~     patients that completed the CACZ885D2307 study~   "
100330|NCT01743872|"~     Iodinated contrast is the current gold standard for infrainguinal angiography imaging in~     patients without renal insufficiency and has also been used with intravascular Optical~     Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as~     carotid arteries. The current debate in the literature for iOCT medium is between iodinated~     contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower~     extremity occlusive disease interventions.~      The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is~     feasible and will produce at least the same quality of imaging as that obtained with~     contrast or dextran without causing the problems of volume overload and renal toxicity seen~     with the two latter mediums.~      Primary Outcomes Measured~        -  Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length~          segment.~        -  Quantitative: Calculations of the area and diameter of each segment will be measured to~          determine if index of refraction has any effect between the three mediums to be tested.~      The investigators expect to find little difference between all three iOCT mediums and hope~     to conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower~     extremity arterial system.~   "
100331|NCT01743859|"~     The primary objective of this study is to determine the complete remission/complete~     remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory~     acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.~   "
100332|NCT01743846|"~     Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic~     variables achieved by a PICCO monitor.~      Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the~     accuracy of CNAP.~   "
100333|NCT01743833|"~     Shoulder impingement has been identified as the most common cause of shoulder pain in the~     adult general population. Sometimes therapeutic pushing on the middle part of the back~     (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do~     not known what causes the decreased shoulder pain. It could be that the therapeutic pushing~     makes things move better. It may be that the person getting their back treatment thinks they~     are better or the physical therapist who provides the manual treatment thinks it works.~   "
100334|NCT01743820|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low~     single-dose primaquine for gametocidal activity against P.falciparum among adult~     glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.~   "
100335|NCT01743807|"~     This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed~     and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who~     are in morphologic remission but are positive for Minimum Residual Disease (MRD). GNKG168 is~     a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an~     effective anti-tumor immune response as they are able to stimulate both innate and adaptive~     immune responses. There will be two strata i.e patients who have received hematopoietic stem~     cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be~     administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed~     by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to~     determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients.~   "
100336|NCT01743794|"~     Introduction : Spine surgery is responsible for intense postoperative pain that can be~     treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia).~     Continuous wound infiltration is an efficient and simple technique with few adverse effects~     yet very few studies have investigated its potential use in spine surgery. Our randomised,~     controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration~     after major spine surgery.~      Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a~     multiholes catheter under muscular layers. Patients are randomised in two groups : The~     treated group receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by~     8 mL/h continuous infusion during 48 hours) and the control group receives saline solution~     (0.9%). In addition, all patients receive patient-controlled intra-venous morphine~     analgesia. The investigators hypothesize that the treated group will consume morphine less~     than the control group.~   "
100337|NCT01743781|"~     1. To evaluate a educational intervention promoting acceptance of comprehensive eye~          examination in rural Guangdong.~        2. To evaluate the impact of acceptance of comprehensive eye examination in rural~          Guangdong.~   "
100338|NCT01743768|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need~     for novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product~     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the~     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).~      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic~     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and~     thereby reduces key features of allergic airway inflammation. DNAzymes are generated~     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)~     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by~     use of any living organism including cell culture or bacteria. The molecules are highly~     water-soluble and will be applied as solution directly in their synthesized form.~      This proof-of-concept study will evaluate the safety, tolerability, efficacy,~     pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male~     patients with mild asthma.~   "
100339|NCT01743755|"~     The present study is designed to investigate the beneficial effects of adjunctive~     dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally~     aiming at assessing what patients benefit from dexamethasone treatment mostly. A large~     multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with~     placebo in 600 patients and with predefined subgroup analyses planned.~   "
100340|NCT01743742|"~     To study the role of single high dose vitamin E and vitamin C in hypoxic ischemic~     encephalopathy in newborns, in reduction of morbidity and adverse neurodevelopmental~     sequelae.~   "
100341|NCT01743729|"~     The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic~     solution compared to placebo in the treatment of dry eye.~   "
100342|NCT01743716|"~     This study aims to examine the relationship between mood and brain activity in adolescent~     girls in order to better understand the genetic and neural predictors of adolescent~     depression. The participants in this study will be healthy female adolescents aged 12-14 and~     their mothers. They will participate for a total of six months. Adolescent participants will~     have three study sessions at McLean Hospital, and during two of them, their mothers will~     also have assessments. Adolescent assessments will include interviews, questionnaires,~     computer tasks, and collection of a saliva sample for genetic analyses. Their second study~     visit will include an fMRI scan. Parent assessments will include an interview,~     questionnaires, and a computer task.~   "
100343|NCT01743703|"~     The diagnosis of abuse in children relies heavily on the presence of skeletal and~     extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And~     the investigators have to complete the skeletal survey with either bone-scan or CT scan or~     whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the~     evaluation of skeletal and extraskeletal lesions in children with cancer or infectious~     diseases. Thus, whole-body MRI would allowed to have total picture of children without~     ionising radiation exposure.~   "
100344|NCT01743690|"~     The aim is to investigate the effect of probiotic bacteria on symptoms and clinical~     manifestations in patients with oral lichen planus (OLP).~      The hypothesis is that probiotic bacteria can favor an oral environment that reduces the~     risk of symptomatic candidal and bacterial infection in OLP.~      The negative influence of improper oral hygiene on OLP is established and overgrowth of~     Candida is a common problem. Nystatin is the only topical antifungal that does not interact~     with other drugs and to which the majority of the candida species are susceptible.~     Symptomatic treatment with fluocinolone is initiated in patients without candidal infection.~     Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of~     pathogens e.g. candida. Different probiotic species have been shown to produce antifungal~     substances and reduce the growth of candida albicans in vitro. The probiotic strain~     Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly~     in a randomized clinical study.~      The study is planned as a blinded, randomized controlled study with four parallel arms. 120~     OLP patients with symptoms form the mucous membranes are included in the study and will~     receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of~     candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo~     group (B) by randomization. The groups will be encouraged to take three tablets per day~     (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the~     probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline~     mouth wash will be taken at baseline, after the treatment period and at follow-up visits at~     8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical~     manifestations and symptoms associated to OLP will be recorded.~   "
100345|NCT01743677|"~     ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine~     whether intensive monitoring of QT interval in target patient populations is required during~     later stages of development. The current study is designed to ascertain whether CP-690,550~     is associated with QTc prolongation.~   "
100346|NCT01743664|"~     Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most~     relevant is the experience of distress related to the disease, that can lead to the~     development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies~     on the efficacy of psychological treatments in MS in spite of its relevance for patients'~     quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement~     Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective~     treatment (together with Cognitive Behavioural Therapy) for PTSD according to international~     guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated~     symptoms of anxiety and depression and Quality of Life. The study design is a randomized~     clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and~     the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in~     the experimental group and 30 in the control group).The psychological assessment will be~     performed in both groups with the same timing and tools: at baseline (T0), after treatment~     (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to~     treatment) with the CAPS and the administration of self reports: Trauma Antecedent~     Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression~     Scale and Functional Assessment of Multiple Sclerosis. The experimental group will undergo~     10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic~     events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and~     comparing the scores of the experimental and the control groups. Primary outcome measures~     will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and~     Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores~     for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up~     (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome~     measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0,~     T1 and T2. The statistical procedure applied will be a repeated measures analysis of~     covariance both on the primary outcome continuous measures and on the secondary ones.~   "
100347|NCT01743651|"~     This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled,~     parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS~     patients with spasticity.~      Eligible subjects will be removed from anti-spasticity mediations for at least one week and~     then begin study drug treatment with daily doses increasing up to the target dose which will~     then be maintained for at least 12 weeks. A down-titration will then occur over two weeks~     with the final study visit occuring at 19 weeks from start of achieving the target dose or~     22 weeks from the Study Visit 1.~   "
100348|NCT01743638|"~     The purpose of this study is to see if MR-guided laser ablation can effectively treat~     prostate tumor recurrences.~   "
100349|NCT01743625|"~     The purpose of this study is to show the effectiveness of COV155 compared to placebo in~     subjects with acute moderate to severe pain following bunionectomy surgery.~   "
100350|NCT01743612|"~     The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of~     the hand with Laser speckle contrast imaging discriminate between patients with systemic~     sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.~   "
100351|NCT01743599|"~     Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction~     is registered with a validated questionaire (International Index of Erectile Function-15).~     Concentration, total number of sperm and motility is determined in freshly delivered~     ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly~     higher rate of retrograde ejaculation than healthy controls.~   "
100352|NCT01743586|"~     The purpose for the 1st phase of this study are to exam longitudinal changes and the impact~     of various treatments on the respiratory muscle function, and the relations with dyspnea,~     functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival~     status (control group). The 2nd phase of this study will investigate the potential~     beneficial effects of chest physiotherapy in the same patient population (intervention~     group).~   "
100389|NCT01743105|"~     The main objective of this study is to evaluate the inter-rater reproducibility of~     diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on~     the first measure) in patients experiencing acute respiratory distress emergencies.~   "
100508|NCT01741558|"~     Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce~     the inflammatory profile in acute ischemic disease and reduce the area of ischemia.~     Methotrexate is a drug that has shown promise in ischemic disease in animal studies.~   "
100353|NCT01743573|"~     This study wants to prove that Yoga Training can improve physical Fitness, immunity, and~     quality of Life of in Breast Cancer Survivors. In summary, our findings show potential~     benefits of yoga for people with cancer in improvements of psychological health. Because of~     the small number of studies having been conducted and the methodological limitations, the~     results should be regarded as preliminary and treated with caution. Our preliminary findings~     also provide practitioners with important information that yoga may be a possible adjunctive~     therapy for cancer patients to help manage psychological distress and to improve quality of~     life.~   "
100354|NCT01743560|"~     Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily~     p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen~     receptor positive breast cancer who have previous experienced recurrence or progression on~     non-steroidal aromatase inhibitor (NSAI) therapy.~   "
100355|NCT01743547|"~     This is a pilot study to establish the feasibility of an eight-week yoga intervention and to~     estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary~     peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent~     cancer.~   "
100356|NCT01743534|"~     The insanities, priority of public health in 2008, have significant prevalency in Limousin,~     region in the ageing demography (1/3 of the population is more than 60 years old against~     1/5th of average in France). To prevent the lack of therapeutic solutions, for these~     evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.~      The insanities deprive gradually the individual of their autonomy, their personality and~     their identity. The help of an institution is sometimes inevitable. In the middle of this~     stressful environment, the patient affected by severe insanity, need marks.~      The aspect of their old objects, significant for them, has to be prioritized because the~     institutional universe, often depersonalized doesn't mean anything for them. In front of~     repeated failures, they're hurt in their self respect.~      The prevention of the undernutrition, comes by a preservation of praxis and pleasure at~     table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular,~     divided) and can be destabilizing for the mentally ill person.~   "
100357|NCT01743521|"~     To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin,~     Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.~   "
100358|NCT01743508|"~     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per~     women. It is estimated that 56 percent of all pregnancies are unintended and the~     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and~     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and~     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units~     in Uganda due to unsafe abortion is reported and considered high in international~     comparison. Studies have revealed that trained midlevel providers can deliver safe post~     abortion care for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1~     analogue misoprostol has been shown to be an effective tool in the treatment of incomplete~     abortions. This option is so far under-used in developing countries, especially outside the~     larger hospitals and private clinics. One significant limiting factor in providing safe post~     abortion care is the lack of providers. So far technical training has been mainly limited to~     physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion~     will support task shifting in places where doctors are costly and scarce. By evaluating the~     effectiveness of mid-level providers (midwives); conducting MVA and administering~     misoprostol treatment of incomplete abortion the project is attempting to contribute to the~     reduction of maternal mortality and morbidity and safeguard high quality of post-abortion~     care.~      Women with incomplete abortion will be randomly allocated to undergo a clinical assessment~     and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy~     as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that~     there are no significant differences in effectiveness and safety between manual vacuum~     aspiration and misoprostol treatment of incomplete abortion provided by physicians and~     midwife.~      The involvement of midlevel providers in treatment of incomplete abortion has previously not~     been systematically evaluated in African health care setting.~   "
100359|NCT01743495|"~     The Johns Hopkins School of Nursing offers this research study which aims to learn more~     about whether services that help with medications, muscle strengthening, pain management and~     changes to houses can help improve older adults' ability to, walk, and take care of~     themselves while saving costs by reducing hospitalizations and nursing home admissions.~   "
100360|NCT01743482|"~     This is an open label, single arm, single center, phase 2 study with the use of the~     antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell~     tumors who are not cured following first or subsequent chemotherapy lines for metastatic~     disease, followed by eventual surgery.~   "
100361|NCT01743469|"~     This is an exploratory proof of concept study to determine the clinical activity of~     tasquinimod in patients with advanced or metastatic hepatocellular carcinoma (Cohort H),~     ovarian carcinoma (Cohort O), renal cell carcinoma (Cohort R) and gastric carcinoma (Cohort~     G) who have progressed after standard therapies.~   "
100362|NCT01743456|"~     Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with~     increased morbidity and mortality. The pathophysiology of POCD is only poorly understood.~     Causes include hypoperfusion, microemboli and the systemic inflammatory response, which~     result in a reduction of cerebral oxygen delivery.~      Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen~     saturation (rSO2).~      The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of~     anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number~     between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely~     low.~      The investigators demonstrated recently that inappropriately high levels of anaesthesia may~     be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard~     et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has~     an effect on postoperative cognitive function in patients undergoing cardiac surgery is~     unknown.~      The investigators hypothesize that the incidence of POCD in elderly patients (> 65 years~     old) at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2~     (interventions when rSO2 drops below 15% of baseline reading) when compared with current~     practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and~     blinded rSO2 measurements).~   "
100363|NCT01743443|"~     To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients~     with progressive lower stage keratoconus.~   "
100452|NCT01742286|"~     The purpose of this study is to estimate the maximum tolerated dose and/or recommended dose~     for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor~     activity and characterize single and multiple-dose pharmacokinetics when administered orally~     to pediatric patients with ALK-activated tumors, with and without food.~   "
108941|NCT01630291|"~     The purpose of this study is to investigate whether electrical stimulation of the nerve~     innervating the tear gland results in tear production in subjects with severe Dry Eye.~   "
100364|NCT01743430|"~     Study 1: Background and Purpose—This study were to set up the telerehabilitation program for~     standing balance training, and to examine the training effects on balance and daily~     activities in subjects with subacute stroke.The null hypothesis included telerehabilitation~     balance training were not significantly different from conventional balance training in~     subjects with subacute stroke.~      Study 2: The purpose of this study was to investigate the effects of telerehabilitation with~     group therapy on balance and daily activities in subjects with stroke living in long-term~     care facilities (LTC).The null hypothesis would be telerehabilitation balance training were~     not significantly different from conventional balance training in subjects with subacute~     stroke.~      study 3:To investigate whether a four-week tele-rehabilitation program can result in~     significant improvements in physical function and quality of life for subjects with chronic~     stroke living in long-term care facilities.~      Study 4: To compare the effects of a home-based telerehabilitation (Tele) with intelligent~     agent systems and a conventional in-home physical therapy (home PT) for subjects with~     stroke.~   "
100365|NCT01743417|"~     Brain training exercises will be provided to children who survived an episode of severe~     malaria. These children will be given assessments for cognition, behaviour and executive~     functions before and after the brain training exercises.~   "
100366|NCT01743404|"~     The purpose of this study is to investigate the anti-atherosclerotic effect of long-term~     anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical~     atherosclerosis of carotid arteries.~   "
100367|NCT01743391|"~     By randomizing sub-fertile women to either control or office-hysteroscopy in the circle~     prior to IVF or ICSI (intracytoplasmatic sperm injection~      ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases~     pregnancy rates in the intervention group.~   "
100368|NCT01743378|"~     A Prospective double-blinded randomized clinical trial to test the effect of transversus~     abdominis plane block on postoperative pain and opoid consumption after abdominal~     hysterectomy.~      Two groups of each 24 patients. All patients are given general anesthesia. The patients are~     randomized to have a ultrasound guided bilateral transversus abdominis plane block with~     either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided~     with a PCA for self administration of morphine.~      Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24~     hours postoperatively as well as the total consumption of morphine after 24 hours.~   "
100369|NCT01743365|"~     The purpose of this study is to evaluate the efficacy and safety of the combination of~     Cisplatin,5-Fluorouracil(5FU) and Afatinib as first-line therapy in patients with advanced~     gastric or gastroesophageal junction cancer. The study will include 55 patients in all. The~     patients will receive open-label Cisplatin intravenous 75mg/m2 on Day 1, 5FU 750mg/m2 at~     24-hour intravenous infusion on Days 1-4, and Afatinib 40mg per os on Days 3-5, 8-12, 15-19.~      The administration of Afatinib will start on Day 3 of each therapy cycle with an~     administration interval on each weekend (Weekday on, Weekend off) for 21 days.~     Instructions are given on the dose reduction scheme in the presence of toxicity. The~     administration of the combination Cisplatin-5FU-Afatinib will be continued until disease~     progression, appearance of significant toxicity, completion of 6 treatment cycles, or~     withdrawal of consent. At completion of 6 cycles of the combination, in the absence of~     disease progression, the administration of Afatinib as maintenance monotherapy will be~     continued until disease progression, appearance of significant toxicity, or withdrawal of~     consent at the weekday on-weekend off schedule. Imaging will be applied once every 8 weeks,~     and once every 12 weeks in the Afatinib maintenance therapy phase.~   "
100370|NCT01743352|"~     The aim is to compare a new technique for assessing mechanical properties of large arteries:~     the Ultrafast echo with the reference technique, the echotracking. This will be done by~     studying in parallel hypertensive patients and controls with both techniques and this will~     revisit old concepts of increased stiffness in hypertensive arteries.~   "
100371|NCT01743339|"~     The primary purpose of this study is to test whether and how cognitive-behavioral therapy~     for insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly~     improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms.~     The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on~     symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and~     to assess the role of neurobiological processes and sleep architecture in mediating~     treatment outcomes.~   "
100372|NCT01743326|"~     Rationale: the facet joints are an important pain generator in chronic neck pain. The~     beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been~     described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated~     Disorders. In patients with degenerative neck complaints a positive effect has been~     described in observational studies. Given this positive effect performing a RCT of RFD in~     this patient population is indicated.~      Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic~     degenerative neck pain.~      Study design: prospective, randomized, double blinded clinical trial. Study population:~     patients older than 25 years, referred to the University Pain Center of Maastricht and the~     Pain Center of Amphia hospital Breda, with chronic axial neck pain.~      Intervention: patients with at least 3 months of neck pain without radiation to the arm~     (only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD +~     local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial~     branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml~     (0.25%). The second group (local anesthesia-group=control group) will only receive the~     application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference~     between the two groups is the RF-denervation of the medial branches.~      Main study parameters/endpoints: the primary research question is to evaluate the extent of~     pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group)~     compared with the local anesthesia-group(control group.~      Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression~     of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient~     Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression~     scale (HADS), and Neck Disability Index (NDI, Dutch version).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will~     undergo a physical examination before and 6 weeks after the intervention, by an independent~     third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each~     of these time points the patients will receive questionnaires to fill out. A puncture of a~     blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the~     needle is needed. Should accidental intravascular injection of local anesthetic occur, the~     dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does~     not pose clinical problems. The dura can be punctured; as a consequence contrast will flow~     in the cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In~     theory a lesion of the nerve root is possible, but the needles are designed to avoid this,~     this complication has not been seen since more than 10 years. Up till now, a transient pain~     is occasionally described after the RF treatment. No hypesthesia or motor complications were~     reported. Since the risks of RF treatment are reported low and more related to needle~     placement there is no difference in risk and burden between the two treatment groups.~   "
100373|NCT01743313|"~     Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and~     changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol~     levels) are examined. Persistent postoperative pain is examined as secondary outcome.~   "
100374|NCT01743300|"~     In this prospective pharmacokinetic we investigate the following topics:~        -  The influence of grapefruit juice and orange juice on the steady-state pharmacokinetics~          of sunitinib in cancer patients~        -  The influence of sunitinib on the pharmacokinetics of midazolam in cancer patients~        -  The relationship between Cytochrome-P450-3A4 (CYP3A4) phenotype, as assessed using the~          midazolam clearance test, and the steady-state pharmacokinetics of sunitinib in cancer~          patients~        -  The effect of grapefruit juice and orange juice on CYP3A4 metabolism~   "
100375|NCT01743287|"~     The purpose of this study is to evaluate efficacy and safety of Imotun capsule in~     osteoarthritis of the knee~   "
100376|NCT01743274|"~     Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional~     images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT~     uses a near-infra-red light source to obtain images of the interior walls of the coronary~     arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess~     placement and response to stenting. - To date, no study has evaluated whether optical~     coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention~     (PCI) and stenting.~      The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided~     angioplasty would provide useful clinical information beyond that obtained by angiography,~     and whether this information would subsequently modify physician behavior and treatment~     choices. In particular, we will evaluate the impact of changes in procedural strategy~     resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after~     angioplasty and stent implantation of a lesion responsible for non-ST segment elevation~     acute coronary syndromes.~   "
100379|NCT01743235|"~     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety~     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive~     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.~      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in~     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory~     mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured~     within 24 hours after each sexual activity. The following hypotheses will be tested:~      Lybridos, as compared to placebo, will significantly increase the number of satisfying~     sexual events.~      The number of satisfying sexual events will not differ significantly between subjects~     treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg~     buspirone alone.~      Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.~      Sexual desire/arousal will not differ significantly between subjects treated with placebo~     and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.~      Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase~     the number of satisfying sexual events and sexual desire/arousal.~   "
100380|NCT01743222|"~     The objective is to determine the safety, tolerability and feasibility of the inguinal~     intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)~   "
100381|NCT01743209|"~     The main objective of the study is to describe the french population of individuals with~     paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed.~     The secondary objectives are the description of social demographic profiles, the personal~     and family histories,psychiatric co-morbidities, the side effects of androgen antagonists~     treatment. This study, the first of its kind in France, may allow to better understand the~     social demographic and clinical profile of sexual offenders with paraphilias treated with~     androgen antagonists.~      To be included, the subject must have committed a sexual offense and must present a~     diagnosis of paraphilia with an indication of treatment with androgen antagonists.~     Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder~     characterized by sexually arousing fantasies, needs or recurrent and intense sexual~     behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of~     oneself or partner, (3) children or other persons without their consent, occurring during a~     period of at least six months (Criterion A). This disorder is responsible for sexual~     behavior which is clinically significant disturbances in social, occupational or other~     important areas of functioning (Criterion B).~      The inclusion of approximately 200 subjects is expected in this study. The inclusion period~     will last for 12 months.~      Data will be codified and only a few investigators will have access to these data. The~     statistical analyse will use the usual descriptive parameters: mean, standard deviation,~     median, interquartile range and range for quantitative variables, frequencies and cumulative~     frequencies (if applicable) for qualitative variables.~   "
100382|NCT01743196|"~     The purpose of this study is to determine if there is a difference in the short term~     response in serum folate after a single dose of folic acid in normal weight and obese women~     of childbearing age.~   "
100383|NCT01743183|"~     This study aims to evaluate pulmonary function and respiratory muscle strength in a group of~     elderly women with hypertension before and after a respiratory muscle training.~   "
100384|NCT01743170|"~     The proportion of hypertensive patients achieving adequate blood pressure control meeting~     guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive~     medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure~     controlled.~      The objectives of this study are:~        1. To test the feasibility of telemonitoring of blood pressure in Flemish general~          practices.~        2. To investigate in a randomized fashion whether telemonitoring enabled self-measurement~          of blood pressure leads to faster blood pressure control than self-measurement without~          the telemonitoring information.~        3. The secondary endpoints include various blood pressure indexes, adverse effects, a~          simple assessment of quality of life, adherence, a log of technical problems, and cost~          effectiveness (EQ-5D-5L).~   "
100385|NCT01743157|"~     A phase I-II study of treatment of metastatic melanoma using induction therapy with~     Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).~   "
100386|NCT01743144|"~     Rationale:~      Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis,~     in which rapid recovery with safe airway after extubation is crucial. Sevoflurane is~     considered the inhaled anesthetic of choice in such procedures, however it has been reported~     that emergence agitation (EA) is a frequent complication in 30-80% of children receiving~     sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the~     incidence of EA in children was not adequately investigated.~      Objective:~      To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4)~     infusion on the incidence of sevoflurane-induced EA in children undergoing~     adenotonsillectomy.~      Study population and sample size:~      Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under~     sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance~     difference of 40% in the incidence of agitation between two groups, with a power of 80% and~     alpha error of 5%.~      Study design:~      A double blind, randomized, placebo controlled study.~      Method:~      In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a~     continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be~     iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end~     of surgery. Post operative emergence agitation will be assessed by using the Pediatric~     Anesthesia Emergence Delirium scale.~      Possible risks:~      Drug side effects such as facial warmth, flushing, dry mouth, and malaise.~      Outcome parameters:~      The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric~     Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue~     analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative~     complications~      Statistical analysis plan:~      Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as~     appropriate. The possible relationship between EA and pain scores will be evaluated with the~     use of Spearman's rank correlation coefficient~      Time plan:~      6-9 months.~   "
100387|NCT01743131|"~     This is a phase II multi-center, randomized, double blind, placebo-controlled trial.~      The investigators are doing this study to see if a new drug, abatacept, can be used together~     with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better~     protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.~      Funding Source - FDA OOPD~   "
100388|NCT01743118|"~     The current most important topical treatments for psoriasis are vitamin D3 analogues and/or~     corticosteroids. The possibility of another effective treatment for psoriasis could be based~     on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.~      The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic~     efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical~     Vitamin-D analogue ointment in a psoriasis plaque test.~   "
100390|NCT01743092|"~     Research specific to women's gambling treatment needs is limited but suggests a critical~     need for women sensitive options and reduced barriers to access. This pilot will test the~     effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination~     with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be~     recruited through flyers, on-line and newspaper ads and randomly assigned to one of two~     groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing~     gambling behaviours, personal history and mood states prior to and after the 12 week study.~     Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b)~     will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable~     additions to current treatments, of special importance to reduce barriers for women. The~     study will contribute to best practices in developing web-based treatments.~   "
100391|NCT01743079|"~     The purpose of this study is to evaluate the efficacy and safety of telbivudine and~     lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in~     highly viraemic mothers.~   "
100392|NCT01743066|"~     To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know~     the levels of vitamin E in patients chronically exposed to high concentration of arsenic and~     if changes are found, what happens when supplemented with vitamin E. The buccal cells and~     serum of patients will be collected for the estimation of vitamin E both before and after~     supplementation with vitamin E. Similar samples will be collected from similar number of~     arsenic exposed controls and healthy volunteers for comparison.~   "
100393|NCT01743053|"~     This is a prospective, randomised, open label, controlled pilot study to evaluate the safety~     and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for~     the management of chronic leg ulcers associated with venous insufficiency. Outcome will be~     compared between study participants receiving standard care (debridement, compression~     therapy) and participants receiving ReCell in addition to standard care.~   "
100394|NCT01743040|"~     This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the~     performance of the CADence device in detecting the existence of clinically significant~     coronary artery disease.~   "
100395|NCT01743027|"~     The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular~     itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge~     (CAC) model.~   "
100396|NCT01743014|"~     The purpose of this study is to determine whether the combination with ramipril and~     clopidogrel leads to further improvement of endothelial function, reduction of oxidative~     stress and reduction of vascular inflammation, compared with ramipril monotherapy, in~     patients with Diabetes Mellitus type 2 and diabetic nephropathy.~   "
100397|NCT01743001|"~     Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects~     with Eisenmenger Syndrome.~   "
100398|NCT01742988|"~     This is a phase I, open-label, dose-escalation study of CUDC-907 in patients with refractory~     or relapsed lymphoma or multiple myeloma. CUDC-907 is a multi-targeted agent designed to~     inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC). The study is~     designed to assess the safety, including the maximum tolerated dose, biologically effective~     dose, the pharmacokinetics, and the anti-cancer activity of CUDC-907.~   "
100399|NCT01742975|"~     A randomized prospective simple-blind interventional study evaluating the efficacy of the~     synthetic adhesive solution Ifabond, in patients undergoing breast cancer surgery. The~     main objective of this study is to determine if the application of Ifabond, in addition to~     the conventional method of breast surgery, reduces the postoperative seroma formation. The~     secondary objective is to assess quality of life immediately after surgery, and the need for~     needle aspiration of the axilla, when using Ifabond.~   "
100400|NCT01742962|"~     The purpose of this exploratory data collection is to strengthen our knowledge of some of~     the rarer distresses following surgical removal of the prostate. In general these are:~        -  Side effects related to sexuality, including:~        -  Altered perception of orgasm,~        -  Orgasm associated pain,~        -  Penile shortening and deformity.~        -  Side effects related to urinary incontinence.~        -  Urinary tract infection after operation.~        -  Influence of distress on sexual quality of life.~        -  Influence of distress on the patient´s sex drive.~      In addition information on a range of demographics and information on the patient´s erectile~     function will be collected.~   "
100401|NCT01742949|"~     This study aims to investigate the benefits of using first line heated humidification. The~     primary objective of this research is to determine the effect of high levels of~     humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it~     is possible to predict which patients benefit the most (i.e. be more adherent with therapy)~     from high levels of humidification delivered by ThermoSmart.~   "
100402|NCT01742936|"~     The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and~     compare obtained results versus standard laboratory coagulation parameters prothrombin time~     (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results~     will also be examined. A total of 100 pediatric patients undergoing spinal surgery or~     cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be~     obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck®~     device. If the two results are comparable, this could have immediate clinical application~     and impact in the operating room as POCT results are available within 2-3 minutes compared~     to 1-2 hours for standard laboratory samples.~   "
100403|NCT01742923|"~     Patients with hypertension have an increased risk of stroke and myocardial infarction.~     However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs~     frequently within this patient group. The purpose of this study is to investigate whether a~     complex tailored intervention in a hospital setting will lead to increased medication~     adherence and fewer cardiovascular events when compared to a usual care group. Interventions~     focus on motivational interviewing, medication review and telephone follow up.~   "
100467|NCT01742091|"~     The purpose of this study is to assess the safety and side effects of multiple doses of~     LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)~     and intravenously (directly into a vein). The study will also test how long it takes the~     study drug to get into the body, how long it takes the body to get rid of it, the overall~     effect of the study drug on the body, and whether antibodies to the study drug are formed.~   "
100404|NCT01742910|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide. In the UK, more than half of people who are over 65 have some cataract~     development in one or both eyes. The only treatment that can restore functional visual~     ability is cataract surgery where the opacified crystalline lens is removed by~     phacoemulsification and an artificial intraocular lens is implanted. It is estimated that~     around 10 million cataract operations are performed around the world each year. Cataract~     operations are generally very successful, with a low risk of serious complications. The most~     common risk is developing a condition called posterior capsule opacification (PCO), which~     causes impaired vision to return.~      During the past two decades, cataract surgery underwent tremendous change and modernisation~     resulting in today's small incision phacoemulsification surgery and a safe technique with a~     short rehabilitation time for the patient. The most frequent long-term complication of~     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,~     refinements in surgical technique and modifications in IOL design and material have led to a~     decrease in the incidence of PCO.~      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial~     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule~     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic~     towards the end of the production process, also called multipiece designs.~      For several reasons such as better ease of use with injector systems and higher efficiency~     in the production process, companies have developed IOLs with open-loop haptics out of one~     block of material, also called single-piece designs. In the case of such single-piece IOLs,~     the haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the~     thick haptics maybe an incomplete closure of the capsule at the optic rim with a reduced~     bending effect of the posterior capsule around the posterior optic edge. Additionally, the~     posterior sharp edge is often discontinuous in the region of the haptic-optic junctions.~     These locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting~     in PCO. Nowadays a multitude of different single piece IOLS are available, many of them~     similar but of course with some differences in regard to the chemical composition of the~     acrylic material and the IOL design.~      The purpose of this study is to compare the intensity of posterior capsule opacification~     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)~     with different design of the sharp posterior edge within a follow up period of three years.~   "
100405|NCT01742897|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic~     system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin~     so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is~     seen mostly in older persons, in which the joints become painful and stiff) participants~     with moderate to severe pain.~   "
100406|NCT01742884|"~     The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome~     exposed to controlled adverse environmental conditions.~   "
100407|NCT01742871|"~     Bleeding under vitamin K antagonists are a major iatrogenic causes of hospitalization,~     subject to a fatal outcome in more than one third of cases, mortality is particularly high~     in cases of serious bleeding, including intracerebral hemorrhage. If the INR measured in~     these patients are often away from the higher value of the target range, a significant~     proportion of bleeding were observed for INR between 2 and 3. The study captures the~     components of the nutritional status of patients on oral anticoagulants, including any~     micronutrient deficiencies, to determine whether nutritional status is an independent risk~     factor for bleeding~   "
100408|NCT01742858|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response~     in three age groups.~   "
100409|NCT01742845|"~     The aim of this prospective, randomised, controlled study is to compare the efficacy of~     ultrasound-guided intermediate cervical block to superficial block for carotid~     endarterectomy.~      Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75~     mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed:~     superficial cervical block (Control group) or, ultrasound guided intermediate cervical block~     (Echo group). Main outcome is cervical block success, defined by surgery performed under~     regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of~     conversion to general anaesthesia, total dose of supplemental topical lidocaine and~     block-related complications.~   "
100410|NCT01742832|"~     The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the~     treatment of major depressive disorder versus citalopram. Doctors want to determine if~     vilazodone is effective for the treatment of major depressive disorder in those who have not~     responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of~     anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and~     citalopram have been approved for the treatment of major depressive disorder. This research~     is being done because the researchers want to find out if vilazodone works in reducing the~     symptoms of depression significantly more than a generic SSRI.~   "
100411|NCT01742819|"~     Glaucoma is one of the leading causes of blindness in the world. The key to prevention of~     visual loss from glaucoma is early detection of the disease or its progression and timely~     treatment. The proposed study will investigate the role of various tests in improving~     detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of~     vision (visual field examination) remains the current standard for detection of progression~     in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced~     glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields.~     The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat~     imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging~     of the central retina (the innermost sensitive tissue lining the inside of the eye), called~     macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The~     macula aids in detailed central vision. Since the macular retinal neural cells are the last~     ones to be affected in glaucoma, measurement of macular retinal thickness could provide~     significant information with regard to the course of glaucoma. In the proposed study,~     glaucoma patients will be tested and followed with various measurements done with newer~     versions of optical coherence tomography (OCT) imaging and visual field machines. The~     patients will undergo repeat imaging and visual field testing every 6 months over the course~     of 5 years. Rates of change will be estimated. We will explore if changes in various outcome~     measures derived from imaging are correlated with the corresponding visual field changes in~     glaucoma, and whether the former can be used as an alternative method for detecting~     simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research~     is that macular OCT parameters are valid structural measures that can be used especially in~     advanced disease to follow the course of glaucoma.~   "
100412|NCT01742806|"~     This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate~     reduce and shortens time until drain removal after minimally invasive surgery for early~     gastric cancer.~   "
100413|NCT01742793|"~     The study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients~     with myeloma) will have an acceptable toxicity profile and that in combination will have~     sufficient activity in the target population (including those previously refractory to HDACi~     monotherapy) to warrant further investigation.~   "
100414|NCT01742780|"~     The purpose of this study is to determine if there is one method of identifying the proximal~     humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4~     methods being evaluated.~   "
100468|NCT01742078|"~     The purpose of this study is to determine if a single dose of LY2541546 has any side effects~     on the body and to determine how long and how much LY2541546 stays in the bloodstream of the~     body.~   "
100509|NCT01741545|"~     The primary objective for this study is to evaluate the proportion of subjects who achieve~     SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects~     with Genotype(GT)-1b, -4 and GT-2, -3~   "
100415|NCT01742767|"~     Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced~     and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth~     factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of~     a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and~     often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on~     Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing~     chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable~     toxicity profiles and generally with an excellent patient compliance.~   "
100416|NCT01742754|"~     Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders~     marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to~     work by shifting the recipient's microbiota toward a eubiotic microbial community that~     resists colonization by pathogenic organisms or decreases its inherent inflammatory~     properties. Several studies now report its efficacy in treatment of severe Clostridium~     difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met~     with some success. This is corroborated by several lines of evidence suggesting dysbiosis~     plays an important role in UC pathogenesis. While a recent study using FMT in patients with~     irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years,~     the extent to which the microbiota is alterable in UC is not known. Indeed, there may be~     particular genetic or immunologic factors in UC leading to selection pressure preventing a~     change in the microbiota. As an initial step into investigating the potential efficacy of~     stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the~     feasibility and stability of transplanted microbiota in a series of 10 patients with mild to~     moderate UC.~   "
100417|NCT01742741|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a~     hospital based clinical research center.~   "
100418|NCT01742728|"~     we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers,~     cytokines, and periodontitis through community-based study held in the Goto city, Japan.~   "
100419|NCT01742715|"~     To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three~     commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS~     network algorithm.~   "
100420|NCT01742702|"~     The aim of the present study was to examine the haemodynamic changes in primary and~     secondary hypertension with a non-invasive haemodynamic measurement protocol utilizing~     radial pulse wave analysis and whole-body impedance cardiography in both supine position and~     during head-up tilt.~   "
100421|NCT01742689|"~     In this study we will compare pain intensity and side effects at different time points after~     the intranasal administration of desmopressin or placebo in patients with acute renal colic~     pain.~   "
100422|NCT01742676|"~     The purpose of this study is to evaluate and compare the safety and efficacy of two drugs~     (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.~   "
100423|NCT01742663|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation~     Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.~      Both the test and reference formulations will also be compared to a placebo formulation to~     test for superiority.~   "
100424|NCT01742650|"~     The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA~     Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of~     suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or~     older) with AO/OTA Weber C type fractures operated within a week after trauma are~     consecutively included into the study. The tibiofibular transfixation is randomly performed~     either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the~     tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is~     assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the~     injury.~   "
100425|NCT01742637|"~     The objective of this study is to evaluate the therapeutic equivalence and safety of~     Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo®~     (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the~     treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test~     and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.~   "
100426|NCT01742624|"~     To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release~     Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy~     and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney~     recipients 1 month after kidney transplantation.~   "
100427|NCT01742611|"~     This is a multi-center, open-labeled, non-comparative study to examine the safety and~     efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with~     hyperphosphatemia not on dialysis.~   "
100428|NCT01742598|"~     The purpose of this study is to assess the safety and performance of the 23mm Portico~     Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe~     symptomatic aortic stenosis~   "
100429|NCT01742585|"~     This is a randomized, double blind, placebo-controlled multi-center study to examine the~     efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not~     on dialysis.~   "
100453|NCT01742273|"~     Patients on hemodialysis (HD) exhibit an immensely increased cardiovascular mortality~     associated with extensive vascular calcification (VC). In the past years the development of~     VC was discovered to be actively regulated and as being influenced by inhibitors of~     calcification (e.g. matrix-Gla-protein, fetuin-A). MGP is produced by vascular smooth muscle~     cells and needs post-translational modification by vitamin K dependent gamma-carboxylation~     to be fully active. Based on the demonstration of increased PIVKA-II levels, about 97% of~     all HD patients exhibit insufficient carboxylation activity. We therefore aim in this~     randomized, controlled study to retard the progress of coronary and aortal calcification as~     assessed by thoracic multislice-CT by the thrice weekly administration of 5 mg vitamin K1~     (phylloquinone) to a total of 348 HD patients over a period of 18 months.~   "
100430|NCT01742572|"~     Several studies have shown differences in health-related outcomes by dietary pattern. These~     patterns have included those participants following vegan (no meat, poultry, fish, dairy, or~     eggs), vegetarian (no meat, poultry, or fish), pesco- vegetarian (no meat or poultry),~     semi-vegetarian (red meat and poultry ≥ 1 time/month and < 1 time/week), or omnivorous~     diets. These studies have shown that of these dietary patterns, vegans have the lowest BMIs,~     lowest prevalence of Type 2 diabetes, and lowest amount of weight gain over 5 years. In~     addition, vegetarians have significantly better metabolic risk factors as compared to~     non-vegetarians. While these initial observational studies have shown benefits to consuming~     more plant-based diets, there have been no randomized trials examining the differences in~     health outcomes among these dietary patterns. To begin exploring this research area, the~     investigators will conduct a pilot study which will randomize participants to one of the 5~     dietary approaches. Participants (n=75) in the NEW DIETs Study will be recruited to follow~     their randomly assigned diet for 8 weeks and attend weekly sessions to learn about nutrition~     and cooking.~   "
100431|NCT01742559|"~     Anesthesia of the soft and hard tissues in the maxilla may require up to five injections.~     Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues~     after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques~     during subgingival scaling and root planning (SRP).~   "
100432|NCT01742546|"~     To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical~     nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome~     in upper trapezius muscle measured by mean change between pre and post treatment of pressure~     pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet~     usage of acetaminophen in both groups.~   "
100433|NCT01742533|"~     Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum~     gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important~     physical and psychological consequences/impact in those patients.~      Premature ovarian failure (POF) is currently managed by non-physiological sex steroid~     regimens which are inadequate at optimizing uterine characteristics.~      Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells~     (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance~     angiogenesis, suggesting the novel and promising therapeutic strategy for POF.~      In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with~     Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure.~     Participants will be followed for an expected average of 48 weeks.~   "
100434|NCT01742520|"~     The purpose of this study is to determine the effect of sucrose 24% for pain prevention on~     preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to~     painful procedure,do not impair neurodevelopmental outcomes of preterm infants~   "
100435|NCT01742507|"~     Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical~     coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as~     part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS),~     except that it can provide much higher resolution of coronary cross sectional images than~     IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained~     full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has~     been shown to be safe in clinical settings and has been used in over 300 patients without~     complication at Queen Mary Hospital.~      In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents~     (ZES) and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and~     specific post-intervention re-study intervals.~      The investigators objective is to investigate the clinical impact and OCT difference on~     early stent healing and late lumen loss between the two new-generation limus-eluting-stents~     - Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating~     polymer.~   "
100436|NCT01742494|"~     Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to~     laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical~     modifications have been proposed but have not yet been tested in randomized trials.~   "
100437|NCT01742481|"~     The proposed study is part of a career development award. The first two phases of research~     involve collaborating with adult survivors of childhood cancer representing both sexes and~     three ethnic/racial groups (African American, Hispanic, and White). THe collaboration will~     focus upon developing educational material that is helpful in teaching survivors about~     health risks related to cancer treatments and about survivorship care. The third phase is a~     randomized controlled trial that will randomly (like a flip of coin)place survivors into one~     of two groups. One group will meet in -person with a group leader three times, once each~     week over three weeks. The other group will receive an information packet that contains~     websites, books, and resources similar to content provided in-person within a group format~     to the other group. The goal is to help adult survivors get involved in specialized~     healthcare so they can remain healthy. This involves getting a copy of their medical record~     to understand what treatments they received and working with health providers to get an~     individualized survivorship care plan.~   "
100438|NCT01742468|"~     The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA~     supplemented products (sausage, tomato spread, milk beverage) on disease activity,~     inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.~   "
100439|NCT01742455|"~     Concerning the promotion of peripheral collateral growth, clinical studies investigating new~     therapeutic strategies have used imprecise assessment methods and therefore determined only~     weak endpoints. In contrast to the coronary circulation, there is currently no gold~     standard available to document successful promotion of collateral growth in patients~     suffering from peripheral artery disease. Therefore, the purpose of this study is to~     evaluate a new invasive method to quantify arterial collateral flow in the lower extremity~     in patients undergoing elective coronary angiography.~   "
100466|NCT01742104|"~     The study aims to evaluate the quality of life (QoL) of patients affected by Primary~     Open-Angle Glaucoma (POAG), using 2 QoL questionnaires:~        1. Glaucoma Symptom Scale (GSS) and~        2. National Eye Institute Visual Function Questionnaire (NEI-VFQ -25). The study will be~          conducted on patients with well known diagnosis of POAG (transversal phase) and on~          patients with first diagnosis of POAG (longitudinal phase).~   "
100440|NCT01742442|"~     About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric~     problems may influence the course of cancer and its treatment. The present study is a~     prospective observational study. Age related problems will be assessed by clinical frailty~     indicators covering areas that are recommended in geriatric oncology. The aim is to describe~     the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of~     age, to investigate the predictive/prognostic impact of these indicators on cancer and~     treatment related morbidity and mortality, and to investigate the association between~     clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory~     response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI),~     Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300~     with 30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration~     with several external national and international centres~   "
100441|NCT01742429|"~     To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for~     resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.~   "
100442|NCT01742416|"~     Arterial cannulation is a commonly performed invasive procedure in the operation room, the~     emergency department, and in the intensive care unit. The indications include the need for~     continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated~     blood sampling for laboratory evaluation. This procedure can be challenging even in the best~     of hands. Traditionally, the artery is located by feeling the pulse of the patient. The~     pulse may, however be weak or absent in patients with hypotension, edema, obesity or local~     thrombosis due to previous arterial cannulation in the same location. Furthermore, the~     catheter may not be passed successfully into the artery, despite apparent good blood return~     on initial puncture, or hematoma and spasms of the artery may develop after failed attempts,~     thus making further attempts even more difficult. While ultrasound (US) is being used with~     increasing frequency for central venous access, fewer clinicians are familiar with US-guided~     arterial catheterization. The aim of this study is to investigate if ultrasound facilitates~     arterial cannulation in children ≤24 months compared with the palpation method and to~     investigate the potential extra costs/savings of introducing the method. This study~     hypothesizes that the ultrasound method will facilitate arterial cannulation in small~     children compared with the palpation method.~   "
100443|NCT01742403|"~     This study is investigating measurement of prostate motion during radiotherapy using the~     implanted gold markers. If motion is greater than 3mm then the beam will be stopped and~     position corrected (gating).~   "
100444|NCT01742390|"~     This trial designed to investigate the effect of switching to aripiprazole from risperidone~     or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in~     adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.~   "
100445|NCT01742377|"~     The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in~     dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in~     normal volunteers.~   "
100446|NCT01742364|"~     The study is designed to test the hypothesis that BCG administration via jet injector will~     produce a comparable immune response and that there will be no significant differences in~     safety or reactogenicity between BCG administration via jet injector and needle and syringe.~      The primary objectives of this study are to...~        1. Compare the safety and reactogenicity of BCG administered intradermally by a jet~          injector device in adults and infants, to BCG administered intradermally by needle and~          syringe;~        2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet~          injector device to infants vaccinated with BCG via needle and syringe.~   "
100447|NCT01742351|"~     The aim of the study is to test the feasibility and acceptability of internet-based~     Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The~     idea is to treat residual depressive symptoms as well as using psychoeducation to improve~     their prognosis. Each participant will have a personal therapist that will provide guidance~     and support throughout the treatment.~   "
100448|NCT01742338|"~     COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused~     by long-term smoking. COPD can get worse, making people sick enough to need hospitalization.~     Corticosteroids are very effective and are almost always used, but nobody knows the right~     dose. High doses may work better but could cause more side effects than low doses. Typical~     treatment lengths last at least one week. This study will be comparing two common regimens:~     either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high~     dose). It is unknown which regimen works better..~   "
100449|NCT01742325|"~     Specific aims:~      Control group(2010/1~2011/6)： Aim 1: Describe the patterns of fatigue, sleep disturbance,~     and pain in children with cancer from perspectives of children and their parents over the~     course of one cycle (five days) of inpatient chemotherapy (CXT).~      Aim 2: Determine, at various time points (during they are hospitalization various four~     times), the associations between fatigue, sleep disturbance, and pain over the course of~     four cycles (there are five days in each cycle) of CTX in children with cancer.~      Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance,~     pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported~     uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with~     cancer.~      Intervention group(2011/7~2012/12)： Aim 4: To test an intervention program (two 20-minute~     sessions of walking around the nurse's station daily, five days a cycle) to reduce the~     symptoms of fatigue and pain and increase quality of sleep.~   "
100450|NCT01742312|"~     Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an~     operation to remove the tumour. Chemotherapy has several effects upon the body, including~     effects upon the systems that control the creation and breakdown of muscle. We aim to review~     these effects by recording changes in the amount of exercise patients are able to undertake~     after chemotherapy and reviewing changes in muscle mass.~   "
100451|NCT01742299|"~     The purpose of this study is to allow continued use of imatinib in patients who are on~     imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs~     (CD&MA) study and are benefiting from the treatment as judged by the investigator.~   "
101915|NCT01723098|"~     The main aim of this study was to analysed the security of a supervised exercise program on~     maternal cardiovascular system and assess the positive effects of this program on maternal~     cardiovascular function and structure~   "
100454|NCT01742260|"~     Formal study hypothesis:~      Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will~     result in the patient producing their own bone to fill the void which will reduce the risk~     of infection and resorption, lead to a better cosmetic result and obviate any long term~     consequence of having a synthetic material in vivo.~      Introduction:~      There are several reasons that parts of the skull may need to be removed:~        -  After trauma to relieve brain swelling~        -  During brain surgery (for brain cancer)~        -  After trauma where the bone is so badly fractured/fragmented it needs to be removed.~      In all but the last case the bone flap is temporarily stored in a freezer and once the brain~     swelling has subsided it is reinserted. This procedure is called autologous cranioplasty;~     autologous, because it originally came from the patient and cranioplasty, referring to the~     repair. Although this is a straightforward procedure, there are a number of complications~     including infection and bone resorption that can occur.~      This study:~      Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a~     ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to~     lead to healing of skull defects. In the present study, it is proposed to add stromal cells~     from a suitable donor to medical grade ceramic granules, place them in between specially~     moulded plastic scaffolds and insert the sandwich into the skull. Both the ceramic and~     plastic materials are medical grade and commonly used in reconstructive surgery, the ceramic~     for packing into bony defects due to trauma or removal of cancer and the polymer in bony~     reconstruction. Both materials are approved by the TGA. They are designed to dissolve away~     over time as the body's own blood vessels and cells populate the sandwich and create the~     patient's new bone. It has been proven that without the encouragement of the cells and~     temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone~     resorption/infection and metal plate infection using traditional methods, it would seem~     prudent to provide a construct that will allow controlled replacement with the patient's own~     bone, thus negating any adverse long-term complications with synthetic materials that remain~     for life.~   "
100455|NCT01742247|"~     Assessment of needs of moisturizers after various laser treatments~   "
100456|NCT01742234|"~     An organ transplant is frequently the best option and, in some cases, the only option to~     save the lives of transplant recipients. Receiving an organ from a living donor eliminates~     the need to wait for a deceased donor, an option that many transplant recipients do not~     survive. However, donating an organ presents health concerns to the donor as well. This~     study will use surveys to evaluate the understanding of risk and psychological pressure that~     living organ donors felt when making the decision to donate. It will also compare~     participants' answers across geographic, racial and socio-economic backgrounds.~   "
100457|NCT01742221|"~     This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of~     HemaMax in healthy male and female volunteers.~   "
100458|NCT01742208|"~     This Phase 2 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and efficacy of LX4211 following daily oral administration for 29 days in patients~     with type 1 diabetes mellitus (T1DM).~   "
100459|NCT01742195|"~     The aim of this study is to determine if the insertion of the linear endobronchial~     ultrasound bronchoscope is more comfortable for patients when done through the nose compared~     to its insertion through the mouth. Our hypothesis is that nasal insertion is more~     comfortable.~   "
100460|NCT01742182|"~     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of~     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not~     well understood, and treatment options remain limited. The proposed research will examine~     markers of the circadian system, sleepiness and sleep quality in PD patients and healthy~     controls. Further, the project will examine effects of bright light exposure on circadin~     function, sleep and alertness in PD.~   "
100461|NCT01742169|"~     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)~     screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy, beginning at~     age 50 and continuing until age 75. Despite this recommendation, rates of CRC screening~     remain inadequate and large disparities exist. Screening rates are lower among Black and~     Hispanic populations, in areas with high poverty rates, among individuals with low~     education, and for those who utilize Medicaid or lack health insurance. This study will~     determine the effectiveness of a multifaceted intervention to increase the number of~     patients who have never been screened for CRC and are cared for at a community health center~     (CHC) that complete a fecal immunochemical test (FIT) within 6 months of randomization to an~     intervention group compared to patients in a usual care group. We believe that the proposed~     intervention will improve the CRC screening rate in a cost-effective and sustainable way,~     ultimately leading to a reduction in the high rate of CRC.~      Aim 1: To conduct a randomized controlled trial to determine if a multifaceted intervention~     increases the proportion of patients who complete a FOBT within 6-months of randomization.~      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of~     never-screened patients who complete FOBT within 6 months of randomization.~      Aim 2: Assess the costs of the intervention and the costs per additional initial screening~     compared to patients who receive usual care.~   "
100462|NCT01742156|"~     Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non~     invasive methods documented in the literature as early signs of coronary artery disease. We~     wish to study the sensitivity and specificity of both signs by conducting a single blind~     study involving patients with documented presence or absence of coronary artery disease via~     angiogram.~   "
100463|NCT01742143|"~     The purpose of this 1 year study is to see if the ICCAN program is working, and to compare~     the ICCAN program to the standard hospital services provided in New York City hospitals,~     like meeting with a Social Worker or a Patient Navigator (a person who provides personal~     hospital guidance).~   "
100464|NCT01742130|"~     The purpose of this study is to determine whether hydration with sodium bicarbonate is more~     effective than hydration with sodium chloride to prevent contrast nephropathy in patients~     undergoing primary coronary intervention for acute ST elevation myocardial infarction.~   "
100465|NCT01742117|"~     Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration~     (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary~     stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some~     studies have suggested that patients who have a certain genetic liver enzyme abnormality~     (known as cytochrome P450 2C19 [CYP2C19] *2 or *3 allele) may have a reduced ability to~     activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is~     thought that perhaps people who have a coronary stent procedure may have this genetic liver~     enzyme abnormality. There is a research genetic test available to determine whether or not~     someone has this genetic liver enzyme abnormality. Ticagrelor, is a newer anti-platelet drug~     that is not dependent on the CYP2C19 liver enzyme for its activation and hence in poor~     clopidogrel metabolizers, alternative drugs like Ticagrelor have been recommended for use as~     an anti-platelet agent after PCI. The purpose of this study is to determine if genetic~     testing can identify the best anti-platelet therapy, for patients who undergo a coronary~     stent placement and do not activate clopidogrel very well.~   "
100469|NCT01742065|"~     Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC)~     screening according to guidelines set by the federal government. CRC is 90% curable with~     timely detection and appropriate treatment of precancerous polyps; increased screening could~     reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal~     education, low income, low access to health care, recent immigrants or Hispanics, are the~     same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs).~     The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is~     exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages~     and target rates. Our results will provide valuable information on how to use electronic~     health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose~     patient populations have disproportionately low CRC screening rates.~      This project, in conjunction with the research team, will use an advisory panel to direct~     the research activities. The advisory panel will be made up of clinicians, leaders,~     researchers, and patients. The panel and team will guide the development of materials, the~     outreach to patients, and the research protocol to best reach FQHC patients who are due for~     colorectal cancer screening.~      This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's,~     and Phase II is rolling out the intervention to between 20-30 clinics.~   "
100470|NCT01742052|"~     The primary objectives of the study are:~        -  To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a~          period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on~          MRI parameters~        -  To evaluate the safety and tolerability of three oral doses of MT-1303 compared to~          placebo given for a period of 24 weeks in subjects with RRMS.~   "
100471|NCT01742039|"~     The primary aim of this study is to determine the safest and most effective therapeutic~     strategy to decrease the incidence of postoperative atrial fibrillation following cardiac~     surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to~     evaluate the length of hospital stay associated with each treatment strategy.~   "
100472|NCT01742026|"~     ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION~   "
100473|NCT01742013|"~     GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino~     acids, peptides, nucleobases, and carbohydrates. This product is approved for improving~     liver function. Also, it has been prescribed for lots of diseases such as menopausal~     disorders, atopic dermatitis, skin cares as well as fatigue for long time. Although its~     action mechanism and clinical effectiveness are not still clear, there are reports which say~     a strong probability of its clinical effectiveness in the chronic fatigue patients.~      This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta~     hydrolysate) in the chronic fatigue patients through a randomized controlled tial.~   "
100474|NCT01742000|"~     The purpose of this study is to investigate the anti-atherosclerotic action of natural drug~     Karinat based on phytoestrogen-rich botanicals in postmenopausal women.~   "
100475|NCT01741987|"~     The purpose of this project is to determine the effectiveness of an eyewash osmoprotective~     lubricant comparing to castor oil containing and non-osmoprotective lubricants in different~     types of DTS and post refractive surgery patients.~   "
100476|NCT01741974|"~     The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric~     action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal~     women.~   "
100477|NCT01741961|"~     Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are~     retrospectively examined.~   "
100478|NCT01741948|"~     There have been reports in the medical literature demonstrating a link between the~     development of provoked vestibulodynia (PVD), a sexual pain disorder, and hormonal~     contraceptive (HC) use. The purpose of this pilot study is to assess the prevalence of HCs~     induced PVD among a HC naïve population, to evaluate which of the components of the HCs are~     associated with a higher risk of the development of PVD, and to evaluate which clinical and~     genetic factors predispose the patient to HCs induced PVD. Assessments will be made through~     patient questionnaires, physical examinations, and blood tests. Microarray techniques will~     be employed to characterize, on a global level, the gene expression profiles of women who~     develop PVD in comparison to those who do not develop PVD. Patients will be followed for a~     year. Results will be used to develop a larger clinical trial.~   "
100479|NCT01741935|"~     An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and~     monitor the progression of a patient's COPD.~      Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current~     knowledge about the disease limits the investigators ability to cure or interfere with the~     progression of the disease. COPD is often characterized by exacerbating infections requiring~     emergency care.~      The project aims to examine whether disease progression of COPD can be better controlled by~     continuously monitoring the patient's physical activity, along with the assessment of~     pulmonary symptoms and lung function. A key question is: can investigators find indicators~     that provides support for early intervention before severe symptoms arise.~      The patient carries a smartphone that records physical activity real-time, daily lung~     function measures, lung disease related symptoms, and use of medication.~      The experimental phase, the first part of the project, covers 25 COPD patients followed up~     to 12 weeks where the primary objective is to examine and verify both new investigational~     methodology and technology.~   "
100480|NCT01741922|"~     The goal is to investigate in patients with high blood pressure, BP, namely, those with~     systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90~     mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA,~     whether changing the time they take the drug (same dose) to bedtime (from taking it at some~     point during the active part of the day) produces a drop in their blood pressure (mean~     systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among~     non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in~     their night BP when the drug is taken in the evening.~   "
100481|NCT01741909|"~     Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The~     investigators believe that intravenous therapy is prolonged more that necessary and that~     oral therapy can be used much earlier in the course of the disease. The investigators plan~     to check if that statement is true and intervene in order to shorten the intravenous~     therapy.~   "
100482|NCT01741896|"~     Computated tomography (CT) is an invaluable medical resource for both physicians and~     surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an~     incredibly powerful means of imaging the human body, there are possible complications to the~     use of contrast including a hypersensitive response and contract induced nephropathy (CIN).~     The latter will typically occur 48-72 hours after administration.~      One recent meta - analysis of serum creatinine levels following contrast enhanced CT found~     6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 %~     had a persisting reduced renal function, with a small minority needing renal replacement~     therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of~     contrast given.~      The mechanism of injury to the kidney is not definitively established, but is thought most~     likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free~     radicals causing direct damage to the kidney and also direct tubular damage.~      Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced~     transient ischaemia at another site could buffer the impact of the contrast medium's~     effects. This was first demonstrated during cardiac angiograms, with those patients whom~     received multiple balloon inflations in the coronary arteries were found to have a lower~     incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised~     that any ischaemia temporarily induced could be nephroprotective. This can be at a point of~     extremity, rather than involving central organs, such as the arm, with ischaemia induced by~     the use of a blood pressure cuff, inflated to above systolic blood pressure levels.~      No studies have been found in the literature attempting to demonstrate this effect in~     relation to contrast CT studies. Consequently, a randomised control clinical trial of~     patients to assess the effectiveness of remote ischaemic preconditioning is proposed.~      Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs~     involving IV contrast is nephroprotective.~   "
100483|NCT01741883|"~     The purpose of this study is to evaluate a side effect prevention training (SEPT) that~     optimizes patients' response expectations before the start of adjuvant endocrine treatment~     (AET) to prevent nocebo side effects and enhance quality of life during longer term drug~     intake.~   "
100484|NCT01741870|"~     To examine the effectiveness of a need-based nutritional intervention strategy in~     improving the nutritional and physical functional status of nursing home elderly.~   "
100485|NCT01741857|"~     This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived~     mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory~     systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments.~     The underlying hypothesis is that the active SLE condition is caused by an abnormal immune~     homeostasis that can be restored by MSCT.~   "
100486|NCT01741844|"~     The purpose of this study is to assess the safety data of etravirine in a natural clinical~     practice.~   "
100487|NCT01741831|"~     The purpose of this study is to assess the safety data of darunavir in a natural clinical~     practice.~   "
100488|NCT01741818|"~     The purpose of this study is to determine the cutoff point for IVC collapsibility index (by~     Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP~     measures less than 8 cmH2o.~   "
100489|NCT01741805|"~     Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is~     defined in the literature as asthma not controlled by medication. In recent years it has~     become known that severe asthma is a variable disease and has subtypes relating to the age~     of onset, type of inflammation and allergy, obesity, etc.~      Our aim is to characterize the phenotypes of severe asthma population in our clinic and~     compare the prevalent phenotypes to the phenotypes described before.~   "
100490|NCT01741792|"~     The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab~     is effective and safe in the treatment of patients with relapsed/refractory diffuse large~     B-cell lymphoma (DLBCL).~   "
100491|NCT01741779|"~     Obesity is a major risk factor for premature arterial abnormalities including high blood~     pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle~     modifications is associated with a decrease in large artery (aorta) stiffness. However,~     along with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration~     results in similar increases in muscle mass and strength than those observed after~     resistance exercise and is feasible for special populations such as the obese and the~     elderly.~      The investigators hypothesis is that weight loss via diet combined with whole body vibration~     training would additively reduce arterial stiffness and blood pressure in obese women. The~     investigators also hypothesize that the improved arterial function with weight loss would be~     associated with beneficial changes in the main mechanisms involved in BP regulation.~   "
100492|NCT01741766|"~     Hypertension is a major risk factor for cardiovascular disease. Hypertension and abdominal~     obesity are associated with dysfunction of the main mechanisms of cardiovascular regulation,~     the autonomic nervous system and the vascular endothelium. Increased sympathetic activity~     and endothelial dysfunction are associated with increased arterial stiffness, which is an~     independent risk factor for the development of hypertension and other cardiovascular~     diseases. The recommended intervention for controlling BP in pre- and stage 1- hypertensive~     individuals is lifestyle modifications such as exercise, and not drug therapy.Although~     aerobic and resistance exercise has been shown to be beneficial for the cardiovascular~     system, special populations such as the elderly and obese may have physical and/or~     musculoskeletal limitations which may limit their participation in these exercise~     modalities.~      Stretching is a form of exercise that is widely recommended for injury prevention. Among the~     benefits of stretching are an increased flexibility, enhanced muscular coordination, stress~     relief, improved range of motion and an improved posture. Previous studies have shown~     stretching training to increase arterial compliance and acutely increase sympathetic nerve~     activity. In addition, low flexibility levels have been found to be associated with arterial~     stiffness. Given that stretching of skeletal muscle causes an increase in sympathetic nerve~     activity; repetitive stimulation of sympathetic activity induced by habitual stretching,~     might chronically reduce resting sympathetic activity. The reduction in sympathetic activity~     might result in a decrease of arterial stiffness and blood pressure.~      The investigators hypothesis is that 8 weeks of stretching training would reduce arterial~     stiffness, blood pressure and sympathetic activity in obese women. The investigators also~     hypothesize that the improved arterial function with stretching would be associated with~     increases in flexibility levels.~   "
100501|NCT01741649|"~     Many solutions are used for cleaning the skin of a patient previous to a surgery. Although~     the efficacy of clorhexidine has been proved in other surgical procedures, there is only a~     retrospective study in cesarean section (they report no benefit of one solution over the~     other). The investigators would like to evaluate the difference in surgical site infection~     in patients after cesarean section comparing preparation of the skin with clorhexidine~     versus povidone.~   "
100502|NCT01741636|"~     Survivorship Care Planning may improve overall well-being and quality of life of colorectal~     and lung cancer survivors~   "
100503|NCT01741623|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult human subjects.~   "
100504|NCT01741610|"~     This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's~     solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access~     line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for~     caesarean section.~   "
100493|NCT01741753|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug, in this case an investigational drug combined with standard drug~     therapy. Phase I studies also try to define the appropriate dose of the investigational drug~     to use for further studies. Investigational means that the drug is still being studied and~     taht research doctors are trying to find out more about it. It also means that the FDA has~     not approved the drug for use in patients, including people with your type of cancer.~      BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to~     better outcomes in many types of cancer.~      Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and~     works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone~     acetate, individuals must also take a glucocorticoid such as prednisone.~      Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel,~     after which treatment with the combination of abiraterone and prednisone has been shown to~     be effective. Evidence has shown an interaction between the pathways through which BKM120~     and abiraterone act on cancer. Therefore, it is thought that the treatment of~     castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone~     plus prednisone. The purpose of this study is to determine a safe dose for the combination~     of daily oral BKM120, abiraterone acetate, and prednisone in patients with~     castrate-resistant metastatic prostate cancer who have received prior treatment with~     docetaxel.~   "
100494|NCT01741740|"~     There are only little data on the risk of chronic complaints (pain and discomfort) following~     open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and~     secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly~     recurrence. The setup was a retrospective two-centre study including patients ≥18 years~     undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs.~     The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes~     patients were examined by a consultant in patients home), pain, discomfort, work, and~     leisure activities. We analysed 295 consecutive patients through a non-validated structured~     questionnaire.~   "
100495|NCT01741727|"~     A study of ABT-414 in subjects with solid tumors.~   "
100496|NCT01741714|"~     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for~     migraine. If the method proves to be effective, it will provide a new non-pharmacological~     treatment option for migraine. This is especially important since some migraineurs do not~     tolerate acute and/or prophylactic medicine, due to side effects or contraindications due to~     comorbidity of other diseases while others do not have effect. Thus, alternative treatment~     options are warranted. The applied methodology of the study will aim towards the highest~     possible research standards. This international study is a collaboration between Akershus~     University Hospital, University of Oslo (UiO), Norway and Macquarie University, Australia.~     The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine.~     By increasing the methodological quality of the investigators research to a very high level,~     the investigators see the method to work as a guide to increase the quality of chiropractic~     research in the future, as previous randomized clinical trials (RCTs) of migraine used~     methodology showing room for improvement.~   "
100497|NCT01741701|"~     The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective~     treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and~     complete two safety follow-up phone calls over a 4 month period.~   "
100498|NCT01741688|"~     This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in~     routine clinical practice in participants with moderate to severe rheumatoid arthritis.~     Eligible participants initiated on tocilizumab treatment in accordance with the local label~     were followed for 6 months.~   "
100499|NCT01741675|"~     ABSTRACT The purpose of the study is to investigate if a monetary incentive can increase the~     response rate for vulnerable children and youth in a postal survey. A secondary purpose is~     to test if monetary incentive has an effect on the content of answers in a postal survey.~     The study is a randomized controlled trial where participants will be randomly allocated to~     receive a questionnaire together with a €15 voucher for a supermarket or to only receive a~     questionnaire. Data are taken from an intervention study aiming at creating network for~     different groups of vulnerable children and youth aged 8-23 years. The questionnaire survey~     in the present study is a follow up survey of the original study which are performed 1-2½~     years after the participant have left the study. Recruitment to the original study is still~     ongoing and the investigators expect the total participation to be around 250. In the~     primary analysis the investigators will estimate the relative risk (RR) to assess whether~     there is a difference between group allocation and questionnaire response rate. The~     investigators will adjust for age in the analysis. In the secondary analyses the~     investigators will test whether scores on the five SDQ scales are different between group~     allocations. The investigators will adjust for the covariates age and gender, since the~     scores may depend on age and gender (4).~   "
100500|NCT01741662|"~     The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders~     and psychocognitive impairments in adolescents surviving childhood leukemia .~      The second objective is to explore the complex relationships between psycocognitive~     development and soiciodemodemographics data, main characteristics of leukemia, treatments,~     side-effects, quality of life and characteristics of proxyies environment.~      3. Materials and Methods The LEA study is based on the constitution of a multi-centric~     prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,~     Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are~     inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980~     (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in~     complete remission and at month 48 for the ALL not grafted in first complete remission.~      The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients~     12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of~     people which corresponds to the Marseille and Nice centers). Patients from this two centers~     are the patients with the more important length of survey, allowing us to produce a not~     biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by~     the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically~     dedicated to the psychological follow-up of children suffering from cancer.~   "
100510|NCT01741532|"~     A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of~     18 months of treatment with deferiprone versus placebo in patients with PKAN.~      This investigator-initiated trial is funded by the European Commission's Seventh Framework~     Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON~     consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA OOPD (Dr.~     Elliott Vichinsky)~   "
100511|NCT01741519|"~     The study will compare the pharmacokinetics (PK), safety and tolerability of long-term~     infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of~     blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic~     cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR)~     and adverse events (AEs).~   "
100512|NCT01741506|"~     The purpose of the study is:~      To estimate patients with lung cancers who will undergo surgery total haemostatic /~     thrombotic capacity pre, per-and postoperatively.~      To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH)~     affects the patient's potential hypercoagulability.~      To investigate whether there are differences in patients who will undergo Video Assisted~     Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.~   "
100513|NCT01741493|"~     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose~     study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and~     multiple dose study in healthy volunteers.~   "
100514|NCT01741480|"~     The study will begin in 2013 whereby patients having an early warning system (EWS) alert~     will be randomized to be seen by the rapid response team (RRT) for triage versus usual care.~     A RRT is usually made up of a nurse and/or a physician who respond to a requested activation~     of the RRT (called an ACT). The intervention will occur as follows:~        1. Real-time monitoring of the eight general hospital wards (GHWs)((10100, 10200,~          11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. Through multiple~          past collaborative efforts and studies involving interventions at BJH, informatics~          personnel have already demonstrated that they can accomplish this task using their~          computing and algorithmic resources. The prediction tool (PT) employed is a validated~          PT aimed at identifying any form of clinical deterioration occurring on a GHW requiring~          ICU transfer or leading to patient death.~        2. Patients meeting the prediction criteria for an increased risk of clinical~          deterioration will be identified on the GHWs. An automated text message will be~          generated that provides the patient's name, their room number, the date and time of the~          message, and text indicating that they meet the criteria for risk of deterioration.~          Messages will only be generated for patients assigned to the intervention group.~        3. The EWS text message will be sent to the on-call RRT nurse's phone. These are phones~          that are transferred from one RRT nurse to the other as changes of shift occur. It is~          their primary means of communicating with the hospital.~        4. The RRT nurse for the intervention patients will go into the flagged patient's room~          within 10 to 15 minutes of receiving the message and perform a clinical assessment.~          Based on the RRT nurse's assessment either no additional action need occur or he/she~          will call either the physician on duty or activate an ACT as well as apply the four~          D's, which was internally established at Barnes-Jewish Hospital (BJH) for treatment of~          patients on GHWs identified to have impending clinical deterioration. The four D's~          refer to the following: Discuss level of care, Drugs for treatment (e.g., antibiotics),~          Diagnostics (lab tests, cultures), and Damage control (e.g., use of intravenous fluids,~          oxygen).~   "
100515|NCT01741467|"~     This study will investigate whether real-time continuous glucose monitoring can be used as a~     tool for behavior change in people with pre-diabetes.~   "
100516|NCT01741454|"~     The purpose of this study is to determine whether combination therapy with Tolterodine ER~     and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent~     symptoms.~      The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will~     provided added benefits in reducing stent symptoms in patients who have had unilateral~     placement of a ureteral stent.~      The investigators hypothesize that combination therapy with tamsulosin and tolterodine ER~     will yield greater symptom relief than tamsulosin alone.~   "
100517|NCT01741441|"~     After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux~     symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and~     inability to belch occurring after surgery have been associated with mixed (acid and weakly~     acid) (MR) or weakly acidic reflux (WAR). To date, few studies have evaluated functional~     outcome after LTF in patients with MR or WAR, with the majority reporting only short-term~     results.~      It has been shown that delayed gastric emptying (DGE) might also be an important factor for~     abdominal distension and adverse outcome after LTF.9,10 However, the correlation between~     poor long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in~     patients with MR or WAR is poorly investigated.~   "
100518|NCT01741428|"~     Early interventions to promote physical activity, dietary lifestyle changes and optimal~     medication for cardiovascular risk factor reduction in over 3 years follow-up. A randomized~     Clinical Trial.~   "
100519|NCT01741415|"~     Despite recent advances in substance abuse interventions, a large percentage of clients~     entering residential treatment for substance use will drop out of treatment prematurely, and~     of the remaining, many will relapse soon after treatment completion. Previous research~     indicates that an individual's ability to withstand psychological distress is a key factor~     necessary to maintain drug and alcohol abstinence and to remain in substance use treatment~     without absconding. In previous work, Dr. Bornovalova developed a specific distress~     tolerance treatment called Skills for Improving Distress Intolerance (SIDI). This~     intervention features skills training in behavioral and acceptance strategies and~     intentional clinical exposure to emotional distress. SIDI was developed and piloted with a~     sample of urban drug users seeking treatment in a residential facility. Individuals~     receiving SIDI exhibited greater improvement in distress tolerance than those in two~     comparison groups (receiving treatment-as-usual and supportive counseling).~      Current study. The investigators received NIDA funding to conduct a randomized clinical~     trial with 325 clients entering a residential substance use treatment facility. Study~     participants will be randomized into two treatment groups: (1) those receiving SIDI and (2)~     those receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions~     over a period of 4 months. Then, the investigators will follow clients for one year to~     examine treatment retention and abstinence.~   "
100530|NCT01741272|"~     The primary objective of this study is to determine if early active range of motion after~     mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6~     weeks and 3 months after surgery. The secondary objective of this study is to determine if~     early mobilization improves disease-specific quality of life and promotes earlier return to~     work/function.~      Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of~     range of motion, improved disease specific quality of life and earlier return to~     work/function if allowed to begin early active range of motion compared to subjects who are~     immobilized in a sling for 6 weeks.~   "
100520|NCT01741402|"~     The objective of this work was to compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults.~     It is a prospective, single blinded, randomized clinical trial performed at Center of~     Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São~     Paulo University. Thirty-two older adults are randomly in control and experimental group, 16~     each one. The study includes only participants scoring at least 24 in the Mini-Mental State~     Examination to rule out effects of dementia; without the presence of depression, according~     to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the~     Berg Balance Scale (EBB ≥ 41).~   "
100521|NCT01741389|"~     The main aim is to examine the influence of daylight and melatonin on the temporal~     variations of hemostatic factors with key roles in the hemostatic process and its~     regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by~     comparing subjects with tetraplegia with able-bodied control subjects.~   "
100522|NCT01741376|"~     The purpose of this study is to examine the role of progesterone (a hormone found in both~     men and women) on stopping cocaine use. The study will examine whether the medication, in~     combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal~     symptoms, impulsivity and stress.~   "
100523|NCT01741363|"~     1. The abundant results from this trial will be helpful for assessing the feasibility of~          increasing stool sampling and shortening screening interval in population setting for~          lower and upper gastrointestinal tract lesions, their long-term effects, and the~          respective cost-effectiveness.~        2. The study will evaluate the value of population-based screen and treatment for H.~          pylori infection when the HPSA is combined with the FIT.~   "
100524|NCT01741350|"~     To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention~     designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by~     comparing risk-behavior outcomes of four weekly intervention sessions with a~     time-and-attention-matched control condition.~   "
100525|NCT01741337|"~     The aim of this clinical trial is to evaluate the effect of an early treatment of~     sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following~     coronary artery bypass graft surgery or other coronary reperfusion.~   "
100526|NCT01741324|"~     Vitamin D has a range of biological effects of public health relevance. Vitamin D status is~     assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L~     indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish~     children are significantly below recommendations, little is known of their vitamin D status.~     The investigators have recently found inadequate vitamin D status in pre-school children~     living in northern Sweden, especially in dark-skinned children and during the winter months~     despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and~     40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The~     aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to~     ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location~     (northern or southern Sweden). Furthermore the investigators will examine if vitamin D~     status affects on health markers as bone density, blood pressure, serum lipids, fatty acids,~     inflammatory and immunological markers and mental wellbeing.~      Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be~     recruited to this trial during November-December 2012. They will be randomized to a vitamin~     D supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three~     months. The randomization will be stratified according to skin color (light or dark)~     according to a method using visual inspection and interviews of parents/guardians. The~     investigators will use a 2×2×2 factorial design to investigate the effects of two different~     doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in~     northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference~     between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha =~     0.05). With an estimated dropout of 10%, a total of 220 children will be included.~      At baseline, the participants will undergo blood sampling for S-25(OH)D and other~     biomarkers, blood pressure and anthropometrical measurements, including bone densitometry~     and body composition using air displacement pletysmography, and the parents will answer a~     questionnaire on behavioral and emotional problems in the participating child using the~     Child Behavior Checklist. These measurements will be repeated at follow-up in February-March~     2013.~   "
100527|NCT01741311|"~     This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original~     HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART~     (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness~     trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use~     practices or sexual risk behavior.~   "
100528|NCT01741298|"~     The metabolic syndrome is increasingly being recognized as a major threat to good health -~     especially cardiovascular health - and its frequency appears to be increasing in relation to~     the current epidemic of obesity. The objective of this study is to determine whether a~     program of enhanced lifestyle intervention can, compared to standard care, reduce the~     frequency and severity of the metabolic syndrome as assessed by clinical, metabolic,~     inflammatory and vascular outcome measures. EC will consist of a 17-session structured,~     lifestyle intervention plan, directed at achieving weight reduction and increasing physical~     activity change through education, behavior modification and stress management, and~     conducted in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a~     Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in~     breaking through barriers in working with socioeconomically disadvantaged members of~     minority groups. All participants will have baseline, 6-monthly and 1-year assessments. This~     project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic~     Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may~     contribute to the progression or amelioration of atherosclerotic processes underlying the~     pathogenesis of coronary heart disease (CHD).~   "
100529|NCT01741285|"~     We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in~     improving small airways dysfunction, especially in ex-smokers and smokers with asthma.~      To investigate this, we will perform a study comparing the efficacy of extra-fine particle~     HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone~     (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in~     ex-smokers and smokers with asthma.~      Study design: This study will be an open-label, randomised, three-way cross-over, two-center~     study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for~     two weeks:~   "
100531|NCT01741259|"~     The purpose of this study is to determine if epidural meperidine administered by~     patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled~     bolus.~   "
110171|NCT01614184|"~     The study goal is to develop a new method of intraoperative lymphatic mapping with~     fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.~   "
100532|NCT01741246|"~     Investigators hypothesize that chronic primary headaches are accompanied by a discrete~     pattern of brain metabolism and activity involving brain structures related to the~     development of acute exacerbations as well as pain modulation. Such structures include the~     brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain~     imaging.~   "
100533|NCT01741233|"~     The overall purpose of the study is to investigate whether there is a relationship between~     26 different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B~     (UV-B) irradiation of the skin and vitamin D status.~      The hypothesis is that vitamin D status are influated by different genetic genotypes in the~     vitamin D pathway.~   "
100534|NCT01741220|"~     The aim of this study is to identify factors influencing work engagement and wellbeing in~     German-speaking intensive-care providers and anesthesiologists.~   "
100535|NCT01741207|"~     We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet~     activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous~     coronary intervention.~   "
100536|NCT01741194|"~     This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of~     daily living, resource utilization, quality of life, pharmacokinetic measures and safety~     among participants with mild to moderate Alzheimer's Disease.~   "
100537|NCT01741181|"~     Background and Objectives :~      The presence of vitamin D deficiency in patients with type 2 diabetes mellitus (T2DM) is~     associated with an increased risk of cardiovascular disease (CVD). We aim to see whether~     supplementation of vitamin D in these patients helps to improve the endothelial function~     (EF) a surrogate marker of CVD risk.~      Hypothesis: Vitamin D supplementation in patients with T2DM and low serum 25(OH) D~     concentrations (<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units~     (30% improvement over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and~     CD45dim CD34+/KDR.~      The investigators will test this hypothesis by comparing 2 groups of T2DM patients~     randomized to placebo or vitamin D3 for 16 weeks.~      Methods:~      This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit~     60 T2DM patients with vitamin D deficiency or insufficiency. Out of these 60 patients , 30~     patients will be started on vitamin D supplementation and 30 patients will be given a~     matched placebo. Endothelial function (EF) will be checked before and after supplementation~     to see a change in EF.~      Significance of Project:~      If this study shows a significant improvement of EF, it would justify larger scale studies~     to show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin~     D supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk.~   "
100538|NCT01741168|"~     Braces have been used o treat stable (not requiring surgery) burst fractures with much~     success. Recently questions have been raised in regards to the importance of the brace. Some~     studies have results that suggest a brace is not important in having a good outcome.~     However, this has never been proven. This study is being conducted to see whether or not~     wearing a brace is important to having a good outcome.~   "
100539|NCT01741155|"~     The purpose of this study is to estimate and compare the objective response rate of SPI-1620~     administered in combination with docetaxel in patients with NSCLC and to determine the~     safety of SPI-1620 when administered in combination with docetaxel.~   "
100540|NCT01741142|"~     The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.~   "
100541|NCT01741129|"~     The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation~     (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant~     treatment in preterm infants.~   "
100542|NCT01741116|"~     The aim of this study is to evaluate efficacy and safety of Dovitinib(TKI258) in patients~     with castration resistant prostate cancer after failure of docetaxel-based chemotherapy.~     Further correlative study for metabolic response using PET image and change in serum~     fibroblast growth factor 23(FGF23) will be conducted.~   "
100543|NCT01741103|"~     The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose~     concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal~     glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood~     glucose concentrations) and indices of oxidation stress in the plasma of these subjects.~   "
100544|NCT01741090|"~     Background & Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to~     differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study~     was done in humans with alcoholic liver cirrhosis. The researchers investigated the~     anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.~      Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and~     maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients~     received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic~     tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected~     two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in~     each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth~     factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were~     measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in~     patients' histology Aim :~      The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow~     derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver~     cirrhosis.~   "
100545|NCT01741077|"~     The purpose of this cross-sectional study was to examine whether or not physical changes or~     adaptations occur in response pregnancy or to the higher intakes of folic acid from~     supplementation typically consumed during the reproductive period.~   "
100546|NCT01741064|"~     The purpose of the study is to evaluate the long term vascular morbidity and mortality in~     kidney transplant recipients based on one year post transplant levels of intact parathyroid~     hormone.~   "
100547|NCT01741051|"~     The purpose of this study is to use an air filter intervention to evaluate the relationship~     between particulate matter air pollution exposure during pregnancy and fetal growth. We~     hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major~     reductions in home indoor concentrations of particulate matter and 2) pregnant women whose~     exposures to particulate matter are reduced by this intervention will give birth to children~     with greater mean body weight for gestational age.~   "
100548|NCT01741038|"~     This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body)~     cancer vaccine step which combines killing a single metastatic tumor lesion by use of~     cryoablation in order to cause the release of tumor-specific markers to the immune system~     and then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an~     adjuvant in order to modulate the immune response and educate the immune system to kill~     other tumor cells where ever they reside in the body.~   "
100549|NCT01741025|"~     The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint~     pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative~     management of the SI joint~   "
100550|NCT01741012|"~     Cervical neoplasia is increased in women with SLE most likely due to cervical infection with~     human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.~     Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients~     (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can~     prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies~     have been done on the use of this vaccine in SLE. The investigators hypothesize that~     Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in~     patients with mild to moderate and minimally active or inactive SLE and measure how well~     they make protective antibodies after receiving the vaccine. In other words this will check~     how well the vaccine works in SLE.~   "
100551|NCT01740999|"~     The operational and favored standard therapy for the treatment of osteoarthritis in the~     distal interphalangeal joint is the arthrodesis, in which a titanium screw is used.~     Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low~     loss of function. But restrictions are reported in fine motor skills.~      The operation with silicone arthroplasty is similar. As an implant, a silicone joint is~     used, which has been sufficiently tested at the metacarpophalangeal joint and~     interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal~     interphalangeal joint and the resulting improved fine motor skills.~   "
100552|NCT01740986|"~     Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial~     Asthma Patients~   "
100553|NCT01740973|"~     Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain,~     especially around the umbilical port is dominating the first postoperative week. Single~     Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative~     incisional pain and improve cosmetic results, but results are not convincing and the risk of~     formation of an umbilical trocar-site hernia is not properly investigated.~      This study aimed to investigate the risk of umbilical trocar-site hernia formation after~     SILC vs. conventional 4-port laparoscopic cholesystectomy.~      Methods This is a cohort registry study with prospective questionnaire and clinical~     follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients~     having a conventional laparoscopic cholecystectomy (consecutively from one month before and~     after SILC. They are matched for age, gender, date of operation, and surgeons skills~     (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site~     hernia formation (operation for a umbilical hernia or clinical hernia).~      The H0 hypothesis is that there is not difference between SILC and conventional.~      Exclusion criteria are: death, operation for acute cholecystitis. The included patients will~     be sent a questionnaire asking for operation for a hernia in the area, suspicion of a~     hernia, and perioperative data that we do not have in the database. Futhermore those~     patients who suspect a hernia will be invited to aclinical exam by a medic to state the~     diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or~     discomfort.~   "
100554|NCT01740960|"~     The results of phase I Namisol® study (Klumpers et al. Br J Clin Pharmacol, 2012), implicate~     that Namisol® may have a favorable PK and PD characteristics and is safe to use in people.~     However, the study included only young adults with a mean age of 21.4 years. In a previous~     THC study, subjects age has been associated with treatment response and tolerance of adverse~     reactions. This association was not supported by Lane et al. and Volicer et al.~      There is concern about the safety and tolerability of THC in the elderly population. This is~     because, elderly persons in general have higher risk of adverse drug reactions due to a~     combination of physiological factors such as decreasing in lean body mass, the reduction of~     renal and hepatic clearance, and medical comorbidity which can lead to polypharmacy and~     drug-drug interactions. Therefore, data from the phase I trial cannot be translated directly~     to an elderly (and likely more vulnerable) population. This makes it important to evaluate~     the safety and tolerability profiles of different Namisol® doses in the elderly. In our~     study in progress Delta-THC in Behavioral Disturbances in Dementia, the Namisol® doses of~     0,75 mg and 1,5 mg are, until now, well tolerated by elderly subjects. These doses are,~     however, very low in comparison with the doses used in phase I study with young adults (5~     mg, 6,5 mg and 8 mg). The current study on the safety and tolerability of relatively high~     doses of Namisol® will help us in the future to provide broad advice on the therapeutic~     index and safety profile of Namisol® in the elderly population.~   "
100555|NCT01740947|"~     The primary objectives of this randomized clinical trial are to evaluate if perioperative~     SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as~     other infectious complications. By reduction of septic complications long-term oncological~     outcome might simultaneously improve.~   "
100556|NCT01740934|"~     This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled,~     parallel-group study followed by an eight-week open-label extension to evaluate the safety,~     tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to~     evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild~     to moderate rosacea.~   "
100620|NCT01740102|"~     Objectives: Despite utilization of available means for cardioprotection during cardiac~     surgery, myocardial injury still occurs. Further improvement of cardioprotection is~     therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive~     method. Laboratory research has shown promising results regarding myocardial survival during~     open heart surgery, but the clinical value of RIPC is still largely unknown. The~     investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces~     the incidence of postoperative atrial fibrillation (POAF).~   "
110416|NCT01610986|"~     The purpose of this study is to determine whether glucose-fructose intake during training~     increases lactate transport and oxidation and improve endurance performance.~   "
100557|NCT01740921|"~     Some gut hormones, called incretins, stimulate insulin production in order to control sugar~     levels but also activate brain centres and signal to stop eating. Current administration of~     incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the~     skin) injection and has been routinely available for diabetic patients for more than 4~     years. It is an effective treatment for the lowering of blood glucose with an average weight~     loss of about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests~     that incretins based treatments may also have beneficial effects on blood vessel function.~     However, it is not known whether this effect is by direct action on the blood vessel~     independent of an improvement of latent inflammation which is typically associated with~     weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this~     study is to determine whether the incretin-based diabetes treatment with the GLP-1~     (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the~     actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It~     will determine whether the improvement in blood vessel function is independent of the effect~     of weight loss and changes in inflammation. This by the study of vascular function before~     and after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with~     1) participants randomized to hypo-caloric diet to achieve a similar weight loss than with~     Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive~     assessment of blood vessel function, body fat distribution and metabolic profile at baseline~     and at the end of the treatment phase will be combined with assessments of inflammation~     markers in blood and in fat tissue biopsies.~   "
100558|NCT01740908|"~     This is an observational research study whose purposes are to see the effects of repeated~     hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral~     circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres~     absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than~     air at sea level. In this research, the concentration of oxygen will be twice the level of~     oxygen at sea level.~   "
100559|NCT01740895|"~     To assess the clinical value of iFR to characterize, without concomitant administration of~     hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as~     determined with fractional flow reserve (FFR)~   "
100560|NCT01740882|"~     Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to~     ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent~     recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method~     is unclear.~      In Denmark the investigators have a nationwide database that records 80% of all ventral~     hernia repairs. The investigators combine data from the Danish Hernia Database, the National~     Patient Registry, and prospective questionnaire and clinical follow-up in order to get the~     true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort.~      Purpose The purpose of this national prospective kohort study is to compare the risk of~     developing recurrence of incisional hernia after laparoscopic incisional hernia repair with~     either absorbable or non-absorbable tacks, and to investigate possible. late complaints in~     terms of pain and discomfort after the two mesh fixation devices.~      The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks~     and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered~     physical examination.~      Material and Method Register-based cohort study of perioperative entry of patient data and~     prospective questionnaire follow-up and depending on the answer to any. clinical trial.~      Follow-up is done by searching the Danish Hernia Database and the National Patient Register~     (to ensure data completeness) and distribution of patient questionnaire as reoperation for~     hernia recurrence is an underestimate of the true recurrence risk.~      Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2~     groups supplemented with multivariate Cox regression analysis. Using non-parametric~     statistics. P <0.05 considered statistically significant.~   "
100561|NCT01740869|"~     The purpose of this study is to determine whether the plasticity of autologous intrathecal~     hematopoietic cells would improve the neurologic and the social skills of pediatric patients~     with autism spectrum disorders.~   "
100562|NCT01740856|"~     Reducing the rest time after diagnostic cardiac catheterization for three hours does not~     increase the complications concerning to the procedure, compared to the rest of five hours.~   "
100563|NCT01740843|"~     In this study the effect of tDCS intensity on motor performance and corticospinal (CS)~     excitability is evaluated. The investigators expect that a positive relationship between~     current intensity and motor performance/CS excitability.~   "
100564|NCT01740830|"~     The current study investigates the effects of tDCS in patients with multiple sclerosis (MS).~     The investigators hypothesize that anodal tDCS will increase motor performance in patients~     with MS.~   "
100565|NCT01740817|"~     The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like~     receptor 4 (TLR4) signaling in human subjects~   "
100566|NCT01740804|"~     Primary endpoint To observe the dynamic changes of CTC during the process of platinum based~     chemotherapy in advanced NSCLC.~      To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and~     PFS).~      Secondary endpoint To study the relationship between CTC and overall survival. To study the~     molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.~   "
100567|NCT01740791|"~     The goal of this study is to assess the safety, tolerability, antiviral activity and~     pharmacokinetics of GS-5816 in HCV treatment naïve subjects with genotypes 1-6.~   "
100568|NCT01740778|"~     To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to~     other common, commercially available lancing systems. Subjects will test the devices at a~     depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini~     blood glucose meter using OneTouch® Ultra® blood glucose test strips from either the~     fingertip or alternate site testing.~   "
100569|NCT01740765|"~     This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on~     energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition~     Research Institute (UNC NRI).~   "
100570|NCT01740752|"~     Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment~     research study between the University of North Carolina (UNC) Eating Disorders Program and~     the UNC Department of Psychology and is funded by the National Institute of Mental Health.~     The study examines two comprehensive treatments as couples face the challenges of anorexia~     nervosa (AN). The program helps patients with AN and their partners address AN symptoms and~     unique stresses that AN places on the romantic relationship.~   "
100621|NCT01740089|"~     The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0~     μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin~     in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.~   "
100571|NCT01740739|"~     The objective of this study is to explore the relationship between the ClearView scan~     results and a variety of cardiovascular risk indicators such as the Coronary Calcium Score,~     Framingham Risk Factors, Reynolds Risk Score, and biomarkers of inflammation. The ClearView~     device is a bio-electrographic tool that may assist medical professionals in rapid~     assessment of the systemic origin of the patient's presenting symptom(s). The ClearView is a~     potentially valuable resource that may benefit a physician's office by offering expedited~     differentiation capabilities. The subsequent results have the potential to include more data~     that would allow rapid patient diagnosis, triage, and treatment; optimized precious resource~     expenditure (nursing, physician, etc.); lower costs to facility, patient and insurance~     company; and decreased office wait time.~   "
100572|NCT01740726|"~     This study focuses on treating adolescents with depression. The study has two main purposes.~     The first is to compare a new form of therapy for depression called Behavioral Activation~     (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more~     involved in activities they find enjoyable, which can reduce symptoms of depression.~     Research shows that both BA and fluoxetine work to reduce depressive symptoms in~     adolescents. However, unlike previous research, this study examines how well the two~     treatment options work in comparison to each other. Participants in the study are randomized~     to receive treatment with either BA or fluoxetine for 18 weeks.~      The second aim of the study is to examine the brain functions of adolescents in both~     treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans~     before and after treatment. The data from these scans will be used to compare the brains of~     participants in the BA condition with those in the fluoxetine condition. Also, the scans may~     show possible differences between participants' brains before and after treatment. These~     data may help scientists determine the ideal form of depression treatment for different~     types of people.~   "
100573|NCT01740713|"~     Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been~     authorised in Europe in 1999 for the treatment of iron overload in patients with~     beta-thalassaemia major when DFO is contraindicated or inadequate. Despite a wide experience~     of DFP there are limited experimental data available on DFP in children and no~     pharmacokinetic data in children under 6 years of age. On the basis of the existing data in~     adults and adolescent, in the DEEP-1 trial a pharmacokinetic bridging model was developed to~     support the dose selection in children aged less than 6 years affected by transfusion~     dependent haemoglobinopathies. The study consisted of two phases, namely an experimental~     phase, during which patients received a single dose and a modeling phase, during which PK~     data obtained after single dose in patients < 6 years of age were analysed in conjunction~     with historical PK data in adults and older children and adolescents. The model-based~     analysis of the data obtained after single dose enabled the assessment of the dosing regimen~     required for the purpose of accurate pharmacokinetic bridging. The ratio between the~     predicted systemic exposure parameters (AUC and Cmax) in the target population and reference~     group were used as basis for recommendation of the dose in the target population.~   "
100574|NCT01740700|"~     The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical~     experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the~     treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).~   "
100575|NCT01740687|"~     The purpose of the post approval study is to evaluate the effectiveness and safety of the~     Essure System when a NovaSure Endometrial Ablation procedure is performed following a~     successful Essure Confirmation Test.~   "
100576|NCT01740674|"~     One of the biggest challenges of conducting research where the investigators follow people~     over a long period of time is keeping the participants involved. One of way that~     investigators may be able to improve participant involvement in research is to give~     participants the opportunity to complete their questionnaires online.~      Here's how the investigators think the Internet data collection system will help to keep~     participants involved and ultimately help to answer important questions about the effects of~     nutrition during pregnancy:~        1. It will allow investigators to present complicated questionnaires in a way that doesn't~          confuse participants. For example, instead of telling participants to skip the~          remainder of a question if they answered no to the first part of the question, the ePRO~          system does the skipping for them. The result is less confusion, fewer questions to~          read, and less of the participant's time.~        2. It provides a convenient way for participants to keep track of where to find the~          questionnaire, and how much they have already completed. Participants sometimes don't~          have time to answer all of the investigator's questions in one sitting. The ePRO system~          keeps track of how much participants have already done and it's ready to keep going~          whenever the participant has time. It also avoids the common problem of losing the~          questionnaires to the household paperwork pile, or worse to the recycling bin.~        3. It provides timely reminders to participants. Study participants, and especially new~          moms, are busy and they forget to complete the questionnaires. The ePRO system can~          provide timely reminders encouraging participants to respond.~        4. It helps participants complete the questionnaires accurately. The ePRO system has an~          automatic error detection ability that will alert participants to any questions they~          missed or completed incorrectly.~      Finding ways to keep participants involved in research is something that all researchers are~     concerned about, and ultimately it's a concern for all Canadians because the results of~     research are often used to make decisions about health care and the kinds of programs that~     governments provide. Losing any participant from the study reduces the ability of policy~     makers to take the best decisions and choices about what health services to fund with~     limited dollars. What the investigators propose is a study to determine whether Internet~     data entry really will keep participants involved in a longitudinal study. Previous studies~     have shown that the internet can be a useful tool for getting people to sign up for research~     and at least one small study showed that using Internet data entry can actually save money.~     But no researchers have actually tested whether it really does a better job than paper based~     questionnaires in terms of keeping participants involved.~      In order to answer this question, the investigators will randomly assign the current Alberta~     Pregnancy Outcomes and Nutrition study participants to either continue receiving the~     paper-based questionnaire or to start receiving the web-based surveys. The investigators~     will follow participants over three assessment occasions (over a period of 18 months) and~     observe any differences between the groups in their involvement. Because the investigators~     are randomly assigning participants to the two groups, differences in involvement will tell~     them about usefulness of Internet data entry as a participant retention tool.~   "
100577|NCT01740661|"~     The purpose of this study is to determine the immediate effects of cryotherapy on the lower~     extremity biomechanics during running.~   "
100578|NCT01740648|"~     This phase I trial studies the side effects and best dose of trametinib when given together~     with fluorouracil and radiation therapy before surgery in treating patients with stage~     II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     trametinib together with fluorouracil and radiation therapy before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed~   "
100622|NCT01740076|"~     To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid~     levels, inflammation and menopausal symptoms in postmenopausal women.~   "
100922|NCT01736163|"~     The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen~     and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour~     based on historical diagnostic whole body scan (DxWBS) records.~   "
100579|NCT01740635|"~     Many older adults have difficulty walking. A wheelchair can improve their participation but~     older adults typically receive little wheelchair training. Structured training programs are~     effective but rely on multiple 1:1 sessions with a skilled clinician. EPIC WheelS combines 2~     brief training sessions and a 4-week home training program delivered using a portable~     computer tablet and monitored by an expert trainer. This study investigates the feasibility~     and potential for using EPIC WheelS with older adult novice wheelchair users in Vancouver~     and Winnipeg, measuring the impact on wheelchair skill, safety and confidence compared to a~     control group receiving only cognitive training.~      Hypotheses: The investigators expect that the feasibility outcomes will be sufficiently~     robust to support conducting a subsequent multi-site RCT. The investigators also expect the~     EPIC WheelS training program will have a significant treatment effect with improvement in~     wheelchair mobility, compared to a control group.~   "
100580|NCT01740622|"~     Aim~      To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to~     injury hazards and subsequent injury-related medical claims for their children.~      Hypothesis~      H1: The investigators anticipate, based on our recently completed trial, that the~     installation of multiple, passive safety devices in the homes of children 6- to 36-month old~     children of CCHMC non-contract employees randomized to the intervention group will reduce~     childhood injuries and medical claims by 50% compared to children of CCHMC non-contract~     employees who do not receive the home safety program.~      H2: Cincinnati Children's Hospital Medical Center Employees whose children are randomized to~     the intervention will have 30% less lost work days compared to employees whose children are~     assigned control group.~   "
100581|NCT01740609|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     immunogenicity of single escalating doses PF-06342674.~   "
100582|NCT01740596|"~     Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the~     safety and efficacy of the C-Pulse® System (C-Pulse).~      The purpose of the study is to determine whether the use of the C-Pulse as a treatment for~     patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such~     that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the~     device in the United States.~   "
100583|NCT01740583|"~     The purpose of this study is to test the safety and device performance of the Mitralign~     system (MPAS) to treat functional mitral valve regurgitation.~   "
100584|NCT01740570|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn~     if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be~     studied in both parts.~      Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell~     division.~   "
100585|NCT01740557|"~     The goal of this clinical research study is to learn the side effects of T-cells injected~     with CXCR2 and NGFR when given in combination with chemotherapy (cyclophosphamide and~     fludarabine) and aldesleukin to patients with metastatic melanoma in an attempt to allow~     them to better localize the tumor. The safety of this combination will also be studied.~   "
100586|NCT01740544|"~     Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex~     (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well~     as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann &~     Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to~     poorer test performance.~   "
100587|NCT01740531|"~     To evaluate the efficacy and safety of S 303 treated red blood cells (RBCs) in subjects who~     require chronic transfusion support due to thalassemia major.~   "
100588|NCT01740518|"~     The purpose of this study is to compare two regimens of low volume (2L) polyethylene~     glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in~     out-patients~   "
100589|NCT01740505|"~     This study will compare three different exercise programs in older adults who report~     difficulty walking and will determine if the programs improve walking.~   "
100590|NCT01740492|"~     This study aims to address both the management and evaluation of pain. The primary aim of~     this study is to determine the efficacy of low dose ketamine in adults with moderate to~     severe pain in the emergency department as compared with parenteral opioids alone. Another~     aim is to examine the safety of low dose ketamine compared to opioids alone.~      The investigators hypothesize that low dose ketamine will result in more effective pain~     control than morphine alone and will not be associated with an increase in adverse events.~   "
100591|NCT01740479|"~     To determine whether, on a background of optimal medical therapy, including ticagrelor,~     opening of all suitable narrowings or blockages found at the time of primary PCI for an~     acute heart attack is better than treating only the culprit lesion in patients with~     multi-vessel disease.~   "
100592|NCT01740466|"~     Epidemiological study about eye discomfort complaints, comorbidities and diagnosis at a~     Brazil`s ophthalmological public care service~   "
100593|NCT01740453|"~     Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic~     dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h).~     The investigators hypothesized that continuous interscalene block would prolonged~     ventilatory impairment~   "
100594|NCT01740440|"~     Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical~     Research)~   "
100595|NCT01740427|"~     The study is designed to compare the clinical benefit following treatment with letrozole in~     combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal~     women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti~     cancer therapies for their advanced/metastatic disease.~   "
100675|NCT01739387|"~     This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose~     inhaler) and a breath activated device (BAI). Patient handling will be assessed using~     assessment criteria which detail the correct handling steps for each inhaler.~   "
100676|NCT01739374|"~     Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long~     lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse~     effects. This study looks at the potential benefit of mesh size reduction regarding avoiding~     operative complications.~   "
100596|NCT01740414|"~     Opioid drugs increase glial cell activation which may be related to the abuse liability of~     opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators~     decrease the positive rewarding aspect of opioids in laboratory animals. Ibudilast (MN-166,~     formerly AV411) is a compound that inhibits the activation of glia. Recent preclinical~     studies demonstrate that while ibudilast increases the analgesic effects of opioids, it~     decreases the rewarding effects of such drugs. It has also been shown that ibudilast~     suppresses morphine-induced release of dopamine, a primary neurotransmitter involved in the~     rewarding and reinforcing effects of abused drugs. Additionally, we recently found that~     ibudilast decreases subjective symptoms of opioid withdrawal in opioid dependent humans~     during detoxification.~      Therefore, the primary aim of this 6-7 week inpatient study is to investigate the ability of~     MN-166 to dose-dependently alter the reinforcing, analgesic, subjective, performance, and~     physiological effects of oxycodone, a commonly abused prescription opioid.~      This study includes a 10-day morphine taper phase, followed by two study phases~     (approximately 18 days each) with daily active ibudilast and placebo administration,~     respectively. After the detoxification phase, participants are randomized to receive placebo~     or MN-166, and then be stabilized on the medication. Thereafter, participants will complete~     laboratory sessions. Subsequently, during Phase 2, participants will cross over to the other~     treatment arm, stabilize, and complete laboratory sessions.~   "
100597|NCT01740401|"~     The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and~     Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The~     investigators expect to see an increase in response rate of the combination over Anti-CTLA-4~     alone and estimate a response rate of approximately 20 % in the proposed population.~   "
100598|NCT01740388|"~     To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6%~     (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial~     conjunctivitis.~   "
100599|NCT01740375|"~     To investigate the role of esophagectomy in complete responders to preoperative~     chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to~     either observation or esophagectomy after concurrent chemoradiotherapy.~   "
100600|NCT01740362|"~     A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or~     severe renal impairment, who do not require hemodialysis, compared to healthy controls.~   "
100601|NCT01740349|"~     This prospective pilot study of 30 pediatric subjects, that are indicated for standard~     colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic~     System and the PillCam Colon Capsule in comparison to standard colonoscopy.~      This study aims~        1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with~          standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.~        2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.~   "
100602|NCT01740336|"~     This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate~     the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in~     patients with locally recurrent or metastatic breast cancer.~   "
100603|NCT01740323|"~     The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding~     in patients receiving XRT for their breast cancer after having completed chemotherapy.~     Patients who have received prior chemotherapy will be eligible, because we have found that~     this enriched population is at particular risk for exhibiting increased NF-kB DNA binding~     following XRT.~   "
100604|NCT01740310|"~     The purpose of study will be to test two vaccine education strategies to learn how they~     impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during~     pregnancy after participating in the intervention. The education strategies will be based on~     the elaboration likelihood model (ELM). This model is based on experimental psychology and~     has been previously used to increase breast cancer screening rates. These education~     strategies will be delivered through routine prenatal care visits to black/African-American~     women in Atlanta.~   "
100605|NCT01740297|"~     Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination~     with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of~     talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone. Talimogene~     laherparepvec will be administered by intratumor injection, and ipilimumab will be~     administered by intravenous infusion for a total of 4 infusions. Subjects will be treated~     with talimogene laherparepvec until complete response, all injectable tumors have~     disappeared, disease progression per a modified Immune-Related Response Criteria (irRC), or~     intolerance of study treatment.~   "
100606|NCT01740284|"~     Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment~     related adverse events when initiating treatment.~      The majority are local allergic reactions within the mouth and/or throat, and most of these~     reactions are mild or moderate. It is anticipated that intake of antihistamine before~     initiation of Grazax treatment would most likely reduce the discomfort associated with~     initiation of Grazax treatment. So this trial was to investigate if administration of~     antihistamine prior to initiation of Grazax treatment results in a reduction of subjects~     reporting local allergic reactions.~   "
100607|NCT01740271|"~     Epirubicin is a common chemotherapy medication used in the treatment of breast cancer.~     However, chemotherapy dosing is calculated based on people's height and weight, which may~     not be the most accurate way. The purpose of this study is to see if epirubicin dosing based~     on people's genetic profiles is better than the usual methods.~   "
100608|NCT01740258|"~     Studies which have separately studied bevacizumab for recurrent gliomas and bevacizumab for~     newly-diagnosed glioma have shown good results and the regimens have been well-tolerated by~     patients. This study seeks to investigate the use of bevacizumab with the standard therapy~     (radiation therapy and temozolomide) in newly diagnosed patients, followed by bevacizumab~     and temozolomide with the continuation of bevacizumab following progression. Two critical~     questions remain- the role of bevacizumab maintenance and bevacizumab at the time of~     progression in a patient previously treated with bevacizumab at the time of initial~     diagnosis.~   "
100923|NCT01736150|"~     The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum~     phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients~     on dialysis.~   "
100609|NCT01740245|"~     Treatments for the macroscopic or pathologic lesions caused by HPV infection can be~     classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments~     generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce~     the risk of local infections.~      The aim of this study is to compare the efficacy and safety of polyhexamethylene~     biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the~     post recovery regimen after surgical treatment of cervical lesions.~      Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to~     receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal~     suppositories, or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM~     vaginal suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6~     weeks.~   "
100610|NCT01740232|"~     Meniscus does not always heal when sutured. The investigators will make small holes in the~     meniscus before repair to promote more bleeding. The investigators expect that will help the~     meniscus to heal better.~   "
100611|NCT01740219|"~     This research study aims to develop an organizational-level intervention to enable~     communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to~     address cancer disparities among Latinos. The investigators partner with faith-based~     organizations, since they play a highly prominent role in Latino community life. This~     three-phase study will: (1) improve understanding of the organizational infrastructure,~     skills and resources required by Latino churches to implement EBIs for cancer control, (2)~     develop a capacity-building intervention; and (3) test the intervention's effectiveness in a~     randomized trial.~   "
100612|NCT01740206|"~     Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity~     disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be~     randomized to one of two groups: stimulant medication administered on the day of surgery or~     stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology~     will be at the discretion of the attending anesthesiologist, but the endpoint will be a~     bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia.~     Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and~     the incidence of hypotension, bradycardia, or administration of medications will be compared~     between the two groups.~   "
100613|NCT01740193|"~     The purpose of this research study is to find the best way to decrease pain in children~     right after surgery whom have had their hernia fixed. Right now, there are two different~     ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is~     better than the other. The method used is often chosen by which one the doctor has more~     experience using. The Investigator plans to find out if one of the methods is more effective~     and/or safer than the other method.~      The results of this study will help learn how to best control pain in children having~     surgery for hernia repair.~   "
100614|NCT01740180|"~     The primary objective of this study is to collect information about how CLIPPERS patients~     are currently being treated in France.~   "
100615|NCT01740167|"~     1. The positive outcomes reported by participants in experimental group after two weeks of~          interventions will be significantly better than before interventions.~        2. The positive outcomes reported by participants in experimental group will be~          significantly better than those in control group after two weeks of providing~          prevention model interventions.~        3. The positive outcomes reported by participants in experimental group will be~          significantly better than those in control group after six months of providing~          prevention model interventions.~   "
100616|NCT01740154|"~     The purpose of this research study is to determine how sunitinib (sunitinib malate) causes~     fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their~     levels of fatigue every two weeks while they are participating in this research study. The~     questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of~     physical measurements for fatigue will be performed before the first dose of sunitinib and~     again (4) weeks later to see if there are any changes in physical level of fatigues~   "
100617|NCT01740141|"~     The aim of the study is to find out if the timing of brachial plexus block, before or after~     surgery, has an impact of the extent of acute postoperative surgical pain or the incidence~     and severity of long-lasting (chronic) pain after surgery.~      This is a prospective, randomized, double blind study in patients with radial fractures~     undergoing surgery with volar plate. The patients will be followed up for 6 months after~     surgery.~   "
100618|NCT01740128|"~     Many people with spinal cord injury (SCI) retain at least some movement below their injury,~     but their muscles often have a 'mind of their own'. Typical exercise programs focus on~     keeping muscles strong and flexible, but don't usually focus on helping patients control~     their muscles. The investigators' exercise research study will compare two different~     programs with the specific goal of improving conscious control of patients' muscles below~     the injury. This study focuses on those with 'chronic' SCI - the injury occurred at least~     one year prior to enrolling.~      This is a single center study taking place in the Bronx, NY.~      The first phase of the study will be observational - the investigators will analyze which~     nerve connections might remain partially intact through the injury (even if the nerves~     aren't consciously controlled). Participants with all severity of SCI may participate in~     this first phase.~      The second phase of the study will involve people who retain at least slight ability to move~     their legs and the ability to move the arms against gravity. Each person will undergo two~     different exercise rehabilitation strategies: weight-supported treadmill training; and~     balance training combined with skilled arm or hand exercises.~      The investigators will compare the effects of these exercise programs on a variety of~     outcomes, including gait speed, balance, strength, and muscle activation in response to~     brain stimulation.~      The investigators hypothesize that participants with chronic SCI undergoing combined~     balance/arm/hand training will show improved outcomes when compared to traditional gait or~     balance training.~   "
100619|NCT01740115|"~     The purpose of this study is to expand and continue a cohort of HIV-infected adults to~     establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current~     substance dependence or ever injection drug use that have a spectrum of alcohol use; and to~     determine the effect of alcohol consumption on changes in bone health prospectively in the~     Cohort.~   "
114709|NCT01554709|"~     The objective of the study is to collect additional information related to the safety and~     performance of the CardioGard Cannula during bypass procedures.~   "
100623|NCT01740063|"~     This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with~     influenza-like illness (ILI). Subjects will enter the study based on listed~     inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza~     virus (IFV).~      Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose~     group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or~     a placebo group.~      The modified intent to treat (mITT) analysis set will include subjects with confirmed~     influenza as documented by qPCR or TCID50. The full analysis set will be used for activity~     analysis and will include all randomized subjects with baseline and treatment data. Per~     protocol, the safety analysis sets are described below in statistical methods.~      A subpopulation of 60 participants will also have additional PK and Immunogenicity blood~     samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all~     study visits.~   "
100624|NCT01740050|"~     While exposure to an obesogenic environment has increased for almost every individual in~     western society, not everyone is equally susceptible to overeating and not everyone becomes~     obese. Teasing apart the physiological underpinnings of those individual seemingly~     protective- differences may contribute to the development of successful preventive measures~     and treatment. Neuroimaging studies started to deliver important insights into the~     neuroanatomical determination of individual eating behavior. However, food intake is not~     only determined by the brain, but is orchestrated by an interaction of peripheral hormones~     with neural circuits and decision-making processes. This interactive axis is also referred~     to as the gut-brain axis. While individual aspects of the axis have been studied~     extensively, detailed insight in the interaction of gut and brain in the regulation of food~     intake is lacking.~      Objective: The current study aims to investigate the effect of a) caloric restriction (very~     low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic~     adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction~     and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on~     gut-brain interactions to find an optimal balance for weight loss and long-term sustained~     weight maintenance.~   "
100625|NCT01740037|"~     Rationale: The treatment of patients with atrial fibrillation is often inadequate due to~     poor guideline adherence. An integrated chronic care program (ICCP) at a specialized~     AF-clinic was found to be superior to usual care provided by a cardiologist in terms of~     cardiovascular hospitalizations and cardiovascular mortality.~      Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of~     cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of~     life and guideline adherence.~      Objectives: primary objective is to show that an ICCP reduces cardiovascular~     hospitalizations and mortality. The secondary objectives include cost-effectiveness,~     guideline adherence, quality of life, patient knowledge and patient compliance in~     medication.~      Study design: randomized controlled trial with two study arms: usual care provided by~     cardiologists (control) versus ICCP at a specialized AF-clinic (intervention) in 9 hospitals~     in the Netherlands. In total 1716 patients with newly diagnosed AF will be included. Total~     duration of the study is 4,5 years and total mean follow-up will be 2,4 years. Data~     collected at inclusion, after 3, 6, 12 months and every year thereafter.~      Study population: Patients older than 18 year with newly diagnosed AF.~      Intervention: treatment through an ICCP at specialized AF clinics, consisting of a nurse~     specialist, cardiologist-supervisor and a guidelines-based information-communication~     technology (ICT) decision support program and a web-based patient centered medication~     management tool and tailored telemonitoring.~   "
100626|NCT01740024|"~     The primary objective of this clinical trial is to quantify the loss of in vivo biological~     potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the~     native allergenic extract (N).~   "
100627|NCT01740011|"~     The primary objective of the present trial is to investigate, the mean operative time and to~     study the frequency and intensity of postoperative shoulder tip pain in patients undergoing~     laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal®~     compared with standard pressure CO2 insufflation systems. The primary hypothesis is that~     patients operated with AirSeal® have a shorter mean operative time and decreased frequency~     and intensity of postoperative shoulder tip pain compared with patients undergoing surgery~     with standard pressure CO2 insufflation systems.~      It is the secondary objective of the trial to evaluate immunologic and anaesthesiological~     aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair~     by observing the immune responses and volume of mechanical ventilation of the two groups~     through measuring various immunologic factors and ventilation volume/CO2 elimination volume.~     Surgical side effects will also be measured as secondary objective.~   "
100628|NCT01739998|"~     Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from~     fish oil) on different inflammatory markers in obese subjects with dietary intervention for~     weight lost.~   "
100629|NCT01739985|"~     The purpose of this study is to evaluate the benefit of addition of droperidol to~     prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative~     vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is~     correlated to the number of molecules or specific procedures used.~   "
100630|NCT01739972|"~     Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an~     improvement of cognitive function, and an increase in sense of well-being/ quality of life~     equivalently compared with L-T4.~   "
100631|NCT01739959|"~     The investigators examined the hypothesis that serum lactate is raised in early necrotizing~     fasciitis to a much greater extent than in other differential diagnoses, such as severe~     cellulitis, and therefore provides a diagnostic indicator.~   "
100632|NCT01739946|"~     The goal of this study is to compare protein markers in the urine of patients with and~     without overactive bladder (OAB) and InterStim®.~   "
100690|NCT01739192|"~     The research proposed in this application will determine the initial efficacy, safety and~     tolerability of a novel drug combination, bupropion and naltrexone, as a pharmacotherapy for~     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted. The~     proposed study is innovative and important because it will provide the impetus for the~     conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of~     bupropion-naltrexone combinations for managing cocaine dependence.~   "
100633|NCT01739933|"~     Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of~     brain dysfunction that is an independent predictor of increased risk of dying, length of~     stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed~     sedative medications—the GABA-ergic benzodiazepines—worsen this brain organ dysfunction. The~     available alternative sedation regimens, the shorter acting GABA-ergic propofol, and the~     alpha2 agonist, dexmedetomidine, have both been shown to be superior to benzodiazepines, and~     yet are different with regard to their effects on innate immunity, bacterial clearance,~     apoptosis, cognition and delirium. The MENDS II study will compare propofol and~     dexmedetomidine, and determine the best sedative medication to reduce delirium and improve~     survival and long-term brain function in our most vulnerable patients— the ventilated septic~     patient.~   "
100634|NCT01739920|"~     The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI)~     eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the~     standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any~     intraocular surgical procedure.~   "
100635|NCT01739907|"~     Iron deficiency and vitamin D deficiencies are common in menstruating women. The present~     assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron~     pyrophosphate) or with iron and vitamin D3 in iron deficient women on:~        -  Iron metabolism~        -  Biomarkers of bone remodelling~        -  Cardiovascular risk indexes~   "
100636|NCT01739894|"~     This is a single arm phase 2 trial evaluating the efficacy and tolerability of~     intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer~     patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty~     patients will be recruited into the study for an estimated period of two years. Paclitaxel~     will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving~     standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14.~     The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy~     will improve treatment efficacy.~   "
100637|NCT01739881|"~     The study aims to determine if there are defining EBUS and confocal endoscopy features as~     well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses~     from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar~     gas VOC from patients with lung cancer will be compared against exhaled breath VOC for~     signature compounds that may complement CT in screening the population at risk.~   "
100638|NCT01739868|"~     The main objective of the study is to understand the pathophysiological mechanisms involved~     in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2~     diabetes risk in the population of patients with pre-diabetes.~   "
100639|NCT01739855|"~     Bariatric surgery leads to rapid weight loss in female and male patients. Less data are~     available about its impact on bone metabolism.~      The aim of this study is the investigation of changes in bone mineral density,bone~     histomorphometric changes, serum bone turnover markers and changes in body fat and muscle~     composition in patients after laparoscopic gastric bypass surgery.~   "
100640|NCT01739842|"~     This study is designed to test whether treatment with kudzu extract will increase the rate~     at which alcohol enters the brain as measured by rapid proton magnetic resonance~     spectroscopy (1H-MRS).~   "
100641|NCT01739829|"~     The purpose of this study is to establish the safety and efficacy of xenotransplantation of~     DIABECELL® in patients with established type 1 diabetes mellitus~   "
100642|NCT01739816|"~     Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to~     patients on ≥4 prescribed drugs taken over ≥3 months.~      Aims:~      To evaluate first experiences shortly after implementation, missed pharmaceutical care~     issues and barriers to implementation on pharmacist's level as well as patient's acceptance~     through qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary~     Care and to evaluate economic, clinical and humanistic outcomes in a subsequent randomized~     controlled trial.~   "
100643|NCT01739803|"~     There is a critical gap in the knowledge on how to implement effective interventions for~     renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and~     clinical outcomes. The objectives of this project were to address this gap through: (1)~     designing, implementing, and evaluating a patient-specific behavioral contract intervention~     to improve RTRs' IST adherence rates (contracts are written, signed agreements between the~     RTR and healthcare provider in which the RTR agrees to be adherent to IST according to~     mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs'~     health-related quality of life (HQoL) and healthcare utilizations and costs. The primary~     hypothesis was that at one year post trial enrollment, RTRs who establish behavioral~     contracts with healthcare professionals will be more adherent than those who do not~     establish behavioral contracts and subsequently will have greater HQoL and lower healthcare~     utilizations and costs. Once it is better understood how to implement effective IST~     adherence intervention programs, clinicians will have a valuable tool to promote therapeutic~     success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued~     the following Specific Aims: (1) determine the effectiveness of an IST adherence~     contract-based intervention on IST adherence; (2) determine the relationship between IST~     adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST~     adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the~     Specific Aims, a randomized controlled trial of the patient-specific behavioral~     contract-based intervention was conducted, and data regarding adherence, HQoL, and~     healthcare utilizations/costs were collected over a 12-month period for each RTR study~     participant and analyzed. This project will promote healthy lives, increase well-being, and~     reduce burden of illness and disparity among adult RTRs by providing data regarding an~     adherence intervention and the impact of IST adherence and the behavioral contract~     intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new~     knowledge will provide critical steps toward optimizing RTRs' graft maintenance,~     productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity,~     mortality, and healthcare costs.~   "
100644|NCT01739790|"~     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is~     widely prescribed for patients with chronic obstructive lung disease (COPD), particularly~     for those who have accompanying symptoms of chronic cough and sputum production. Compared to~     placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in~     patients with COPD and chronic bronchitis.~   "
100645|NCT01739777|"~     The purpose of this study is to determine the safety and clinical effectiveness of umbilical~     cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.~   "
100700|NCT01739062|"~     The preferred method for early detection of prostate cancer (PCa) in older men with family~     history is the Prostate Specific Antigen test (PSA test), although the method is imprecise.~     It produces a high number of false-positive results and increases the risk of over-diagnosis~     and over-treatment. Yet, an increasing number of men get the PSA test as part of~     unsystematic screening. Genetic risk assessment may be a better way to identify men with low~     risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can~     reduce the number of patients who get a PSA test as part of unsystematic screening.~   "
100646|NCT01739764|"~     This open-label, multicenter, non-randomized study will provide continued access to~     vemurafenib for eligible patients with BRAF V600 mutation-positive malignancy, who were~     previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the~     protocol's criteria for disease progression, or are treated beyond progression and are still~     deriving clinical benefit (as assessed by investigator), and may therefore potentially~     benefit from continued treatment with vemurafenib. Patients will receive treatment with~     vemurafenib 960 mg orally twice daily or, if the dose was reduced in an antecedent protocol,~     the dose of the last visit of the antecedent study (minimum 480 mg orally twice daily).~     Treatment will continue until progression of disease or as long as the patient is deriving~     clinical benefit, as judged by the investigator, or until unacceptable toxicity occurs.~   "
100647|NCT01739751|"~     Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice~     is not good enough to increase the physical activity level. The aim of the study is to~     determine the effects of pedometers in the physical level in COPD patients.~   "
100648|NCT01739738|"~     The purpose of the study is to investigate the impact of ureteral stents on the functioning~     of ureteral peristalsis (normal contractions in the ureteral organ muscle).~   "
100649|NCT01739725|"~     The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and~     comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting~     the kidney and the bladder) to ultimately improve patient comfort and decrease the need for~     painkillers.~   "
100650|NCT01739712|"~     Sleep intervention for youth with diabetes~   "
100651|NCT01739699|"~     This is a prospective randomized double blinded trial study involving 128 patients~     undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by~     the sealed envelope technique. The anesthesiologist and nurses who will be administering the~     placebo or intravenous acetaminophen will be blinded to the group in which patients are~     assigned.~      The following general perioperative data will be recorded: patient information/preoperative~     data, procedural information, postoperative information, and overall satisfaction of pain~     management at 24 hours after surgery.~      Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will~     require no opioids in the first 24 hour postoperative period. With the use of intravenous~     acetaminophen, it is hypothesized that the number of patients that do not require opioids in~     the first 24 hours after surgery will double.~   "
100652|NCT01739686|"~     Chronic heart failure is an important public health problem as it is a leading cause of~     disability, hospitalization, death, and costs. People who live with advanced chronic heart~     failure suffer from numerous symptoms that affect their daily lives. The investigators are~     conducting a randomized clinical trial to evaluate a symptom management and psychosocial~     care intervention to improve health status (symptom burden, functioning, and quality of~     life). The results will be directly relevant to patients and families who suffer with this~     illness, as well as to providers, payers, and other researchers.~   "
100653|NCT01739673|"~     This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application~     (also often referred to as corneal collagen crosslinking) as a method to enhance treatment~     of infectious keratitis.~   "
100654|NCT01739660|"~     This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase~     administered to hemodialysis patients.~      A single dose of pegloticase will be administered intravenously to male or female~     hemodialysis patients (N = 12) starting 3 hour prior to dialysis.~      The study consists of a Screening Period, a Treatment Period, and Follow up Period.~   "
100655|NCT01739647|"~     This is a single dose study in healthy male and female (of non-child bearing potential)~     volunteers, to assess the safety, effects on the body, and blood and urine drug levels of~     AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease~   "
100656|NCT01739634|"~     Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some~     cases life threatening. Findings in such patients include volume depletion, renal~     insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care,~     reduced quality of life, and treatment delays. Not all patients benefit from conventional~     anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have~     water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb~     the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we~     will investigate if starting 1 g CASAD three times a day will ameliorate the severity of~     diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in~     some cases life threatening. Findings in such patients include volume depletion, renal~     insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will~     reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.~   "
100657|NCT01739621|"~     To further determine the safety and efficacy of Proellex in premenopausal women with uterine~     fibroids who have previously completed study ZPV-200.~   "
100658|NCT01739608|"~     The objectives of this multicenter, randomized trial is to assess the participation rate~     achievable through two different screening strategies (Computed Tomographic Colonography-CTC~     and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced~     adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for~     CTC screening will be also assessed. The trial involves 10 Italian centers located in the~     Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for~     recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family~     history or hereditary syndromes; personal history of inflammatory bowel disease; patients~     screened by colonoscopy or FOBT within 2 years; severe disease.~   "
100659|NCT01739595|"~     The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and~     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism~     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with~     placebo. Subjects must not have previously been treated with testosterone products within~     the last 6 months.~   "
100660|NCT01739582|"~     To determine the safety profile of Androxal in men with secondary hypogonadism.~   "
100924|NCT01736137|"~     The purpose of this study is to assess functional capacity, quality of life and functioning~     of the autonomic nervous system in heart failure patients on beta-blocker treatment. The~     study hypothesis is that subjects who walk less distance, have lower quality of life and~     reduced heart rate variability during the six minute walk test.~   "
100661|NCT01739569|"~     The aim of this study is to investigate the impact of increased availability of healthy food~     and drink during working hours on reaction time and well-being in physicians and nursing~     staff.~      Hospital medical staff often works long and hectic hours, without adequate meal or rest~     breaks in order to provide 24-hour care. This is a concern, as not only the staff's~     well-being is important to the individual welfare, but it is also vital to the quality and~     safety of the care their patients receive. The investigators believe that by focusing on~     physicians and nursing staffs nutrition the investigators will see a positive effect on~     staff performance and well-being - and thus ultimately possibly on patient safety.~      Hypothesis: The provision of healthy lunch and snack meal during working hours for a period~     of 4 weeks will improve reaction time and well-being compared to habitual diet in~     physicians, nurses and nursing assistants.~   "
100662|NCT01739556|"~     Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after~     primary percutaneous coronary intervention (PPCI), aimed at protecting against stent~     thrombosis and increased mortality. Recent aggregometric assays have shown that up to one~     third of acute coronary syndrome patients treated with clopidogrel have incomplete~     inhibition of adenosine diphosphate(ADP)-induced platelet aggregation while the number of~     patients treated with aspirin who have incomplete inhibition of thromboxane A2-induced~     platelet aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has~     been associated with an increased rate of ischemic events after PCI. However, recent large~     trials did not show a clinical benefit of TPR-guided therapy modification in acute coronary~     syndrome patients treated by PCI.~      On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation~     Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized,~     parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet~     therapy modification is superior to standard antiplatelet regimen among intermediate to~     high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with~     control arm, interventional study arm will have similar rates of non-coronary artery bypass~     graft surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI)~     patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing~     PPCI will be randomly allocated to treatment modification or standard treatment. Low~     responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel~     will receive 180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after~     PPCI.~   "
100663|NCT01739543|"~     A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.~   "
100664|NCT01739530|"~     Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques~     including cell harvesting from lipoaspirates obtained from healthy donors, expansion of~     adipose tissue derived stem cells, and differentiation into pure and immature adipocytes.~     This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL~     and followed for 8 weeks according to the clinical trial protocol.~   "
100665|NCT01739517|"~     This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high~     in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition~     dependent patients with short gut syndrome.~   "
100666|NCT01739504|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly~     to affected joints.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Osteoarthritis.~   "
100667|NCT01739491|"~     The purpose of this study is to assess safety and effectiveness of extended bendamustine in~     the treatment of chronic lymphocytic leukemia (CLL).~   "
100668|NCT01739478|"~     The aim of this study is to compare the effect of packing and non-packing on the healing~     rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost~     effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no~     difference in time to healing and non-packing is shown to be safe, acceptable to the patient~     and cost effective, this approach may become more widely accepted.~   "
100669|NCT01739465|"~     The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic~     therapy for inoperable cholangiocarcinoma~   "
100670|NCT01739452|"~     Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of~     patients with MDS. The information will be collected retrospectively from diagnosis of MDS,~     until the date of December 31, 2011.~   "
100671|NCT01739439|"~     This phase I trial studies the side effects and best dose of radiosurgery boost following~     chemoradiation in treating patients with locally advanced pancreatic cancer that may or may~     not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and~     radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to~     save the part of the body where the cancer started~   "
100672|NCT01739426|"~     The primary objective of this study is to evaluation the success of endoscopic treatment of~     Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of~     swallowing function at 12 months post-surgery.~   "
100673|NCT01739413|"~     Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It~     is unclear, however, whether the preoperative metabolic status of the surgical patient plays~     a role in the degree of this hyperglycemic response. For instance, the presence of low~     insulin sensitivity before surgery could predispose the individual to an altered metabolic~     response after surgery. In this case, it would be appropriate to identify adequate~     interventions that attenuate the response to surgical stress and facilitate the recovery~     process.~      The aims of this research projects are the following:~        1. To determine the extent in which epidural local anesthetics, initiated before surgery~          and continued after surgery, improves insulin secretion in patients with preoperative~          low insulin sensitivity.~        2. To understand which measures of postoperative recovery are sensitive to the restoration~          of insulin secretion in this particular group of patients~   "
100674|NCT01739400|"~     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used~     for treatment of Eisenmenger syndrome.~   "
100677|NCT01739361|"~     Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia,~     hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free~     hemoglobin in these patient population has been associated with poor outcomes, including an~     association with an increased risk of death. Acetaminophen may have a protective effect in~     these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose~     of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults~     with severe sepsis and detectable cell-free hemoglobin.~      The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation,~     as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis~     and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The~     secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin~     treated with acetaminophen will have better clinical outcomes, including decreased incidence~     of acute kidney injury and lower rates of hospital mortality, compared to those who receive~     placebo.~   "
100678|NCT01739348|"~     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is~     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo~     administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study~     hypotheses for Part I are that at least one verubecestat dose is superior to placebo at 78~     weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment~     Scale Cognitive Subscale (ADAS-Cog) score and that at least one verubecestat dose is~     superior to placebo at 78 weeks of treatment with respect to change from Baseline in~     Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score.~     The first approximately 400 participants entering Part I of the study are identified as the~     Safety Cohort. Participants who complete Part I of the study may choose to participate in~     Part II, which is a long term double-blind extension to assess efficacy and safety of~     verubecestat administered for up to an additional 260 weeks.~   "
100679|NCT01739335|"~     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left~     untreated or under-treated, it can become a chronic condition associated with significant~     distress, depression, aggression, family disruption, and substance abuse. There is also~     accumulating evidence that combat-related PTSD is associated with an increased risk of~     morbidity and mortality. For the welfare of returning Veterans with PTSD and their families,~     it is critical that this disorder is promptly identified and effectively treated.~     Considerable advances that have been made in the assessment and treatment of PTSD in recent~     years; however, psychopharmacological treatments have been shown to be largely ineffective~     for Veterans with PTSD.~      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -~     pharmacological manipulation of the body's major stress system (the~     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is~     a glucocorticoid receptor (GR) antagonist with peripheral and central nervous system~     effects, making it a compound of interest in the treatment of stress related disorders.~     There is abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought~     to underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.~     Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and~     lead to clinically meaningful improvement in symptoms and cognition. There is preliminary~     evidence that short-term mifepristone treatment has sustained beneficial effects on mood,~     cognition and sleep disturbance in some neuropsychiatric conditions (major depression,~     bipolar disorder, primary insomnia). That there can be sustained clinical and~     neuropsychological effects of mifepristone and normalization of basal HPA axis activity~     after drug discontinuation in these disorders, has led to the view that mifepristone's~     actions include recalibration of a dysregulated HPA axis. Accordingly, the investigators~     propose to study the effects of mifepristone in Veterans with chronic PTSD to determine if~     it is efficacious in improving PTSD symptoms and associated clinical outcomes. To better~     understand the mechanism of action of mifepristone the investigators propose to assess the~     effects of mifepristone on HPA axis activity and their relationship to treatment outcome and~     clinical response.~      To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site,~     double-blind, placebo controlled trial of mifepristone in Veteran outpatients with~     military-related PTSD through the VA's Cooperative Clinical Trial Award program. The~     investigators propose to enroll 90 unmedicated male Veterans with military related PTSD at~     four VA sites (Salisbury, NC, Bronx, NY, Durham, NC, and San Diego, CA). Eligible Veterans~     will be randomly assigned in parallel groups to treatment with 600 mg/day mifepristone or~     placebo for one week and followed for up to three months. In this initial trial the~     investigators propose to study the effects of mifepristone in Veterans with PTSD as~     monotherapy, rather than as an adjunctive treatment, in order to better detect a signal if~     there is one.~      The investigators will also describe the effects of mifepristone on several other clinical~     parameters including PTSD symptomology, depression severity, sleep quality, and functional~     impairment. Several measures of neuroendocrine functioning will also be obtained to explore~     the relationship of plasma cortisol and adrenocorticotropic hormone (ACTH) levels to~     clinical response and the time to addition of rescue medications.~   "
100680|NCT01739322|"~     The objective of this study is to determine the biologic activity of a Platanus acerifolia~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
100681|NCT01739309|"~     The purpose of this study is to estimate the disease control rate with LY2835219 for~     relapsed or refractory mantle cell lymphoma.~   "
100682|NCT01739296|"~     This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar~     strapping in knee osteoarthritis treatment.~   "
100683|NCT01739283|"~     Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and~     hypoglycemia in type 1 diabetes.~   "
100684|NCT01739270|"~     Adding dexamethasone to local anesthetic will significantly prolong duration of brachial~     plexus anesthesia and analgesia.~   "
100685|NCT01739257|"~     The effect of medical humanities on medical student bias and clinical management is unclear.~     This study characterized medical student attitudes toward obese individuals and whether~     reading a play employing empathic characters can modulate negative reactions.~   "
100686|NCT01739244|"~     The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local~     tolerability and intraocular pressure lowering effect of three different doses of SYL040012~     in subjects with ocular hypertension or open-angle glaucoma.~   "
100687|NCT01739231|"~     This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527).~     ACE527 is a live attenuated vaccine that is being made to prevent disease from~     enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children~     living in developing countries and in travelers to those countries. This research study is~     also testing an investigational adjuvant called dmLT. An adjuvant is something that is added~     to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A~     aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe,~     tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine~     by itself or the vaccine combined with teh adjuvant prevents diarrheal disease when~     challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part~     A, and they will be required to stay in the research facility for several nights for the~     first dose, but will not be required to stay overnight for the second and third doses.~     Participants will be assigned to receive either the vaccine alone, the vaccine with~     adjuvant, or placebo by mouth. Study procedures include: stool samples, blood samples, and~     documentation of side effects. Participants will be involved in study related procedures for~     about 8 months.~      Interested volunteers from Part A will along with volunteers who were never vaccinated in~     Part A will return to participate in Part B. These volunteers will be required to stay~     overnight in the research facility for several nights after challenge, after which they will~     be treated with antibiotics and sent home. Study procedures include stool samples, blood~     samples, and documentation of infection with ETEC H10407. If the vaccine with/without~     adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine~     with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.~   "
100688|NCT01739218|"~     This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant~     Avastin (bevacizumab) in participants with initially unresectable, FIGO stage IIIC/IV~     ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of~     carboplatin plus paclitaxel with or without Avastin 15 milligrams per kilogram (mg/kg)~     intravenously every 3 weeks in Cycles 1 to 3 before surgery. All participants will receive~     Avastin 15 mg/kg intravenously every 3 weeks for Cycles 6 to 26. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs, for up to a maximum~     of 26 cycles.~   "
100689|NCT01739205|"~     The major objective of this project is to determine if compared to Standard Care (SC), a~     Community Approach to Lifestyle Modification for Diabetes (CALM-D) program including diet,~     exercise and coping skills training, can decrease depression, weight and HbA1c and improve~     medication adherence in low income, primarily Black and Latino/Hispanic, depressed,~     overweight, Type 2 diabetic patients seen in a large, comprehensive, community health~     center. Type 2 diabetes is a major risk factor for coronary heart disease (CHD). Obesity,~     poor glycemic control, depression, low socioeconomic status (SES) and being a member of a~     racial/ethnic minority group all increase this risk.~      The project will compare 100 CALM-D and 100 SC participants. Following 3 run-in sessions~     assessment sessions to determine eligibility, given to both SC and CALM-D participants, SC~     patients will be treated in accordance with ADA Clinical Practice Guidelines (2005) and also~     assessed by project staff at baseline, 6 months and 1 year. The CALM-D participants will~     receive 2 individual stress management and lifestyle sessions followed by 2 weekly group~     sessions. Then 4 bi-weekly sessions will be followed by 9 monthly sessions for a total of 17~     sessions. Secondary objectives of the project are to determine if compared to SC, CALM-D can~     improve glucose tolerance to challenge, insulin resistance, oxidative stress, inflammation,~     procoagulation, lipid profile, endothelial function resting blood pressure, cardiac and~     vascular function, cardiac morphology, psychosocial functioning and health quality of life.~     As many of the participants will already have been prescribed aspirin, statins, oral~     hypoglycemics and other medications, an important objective of the project will be to assess~     the extent to which improved adherence to medications - a goal of the CALM-D program - can~     account for improved intervention effects.~   "
101142|NCT01733277|"~     The primary objective of this study is to identify osteoarthritis (OA) structural changes,~     as assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the~     PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee~     experiencing moderate to severe pain (VAS ≥ 40 mm).~   "
100691|NCT01739179|"~     Ventriculoperitoneal shunting (VPS) was first described at the beginning of the 20th century~     as a diversionary procedure in patients with a hydrocephalus. After the introduction of~     silastic catheters in the 1970's this method became the treatment of choice for children and~     adults with communicating hydrocephalus. The average patient necessitating VPS will undergo~     at least two shunt revisions every three years, with some patients requiring more than~     twenty revisions within the first year. Therefore, any technical improvement with a positive~     impact on the revision rate not only benefits the patient through a reduction of the~     surgical burden but may also have economic advantages.~      Distal shunt failures - either due to improper placement or secondary dislocation of the~     distal catheter out of the peritoneal cavity - have been reported in 10-30% of cases.~     Catheter placement in obese patients and in patients with adhesions owing to previous~     abdominal surgery remains challenging. Most neurosurgeons will carry out a mini-laparotomy~     to allow for the placement of the distal catheter end within the peritoneal cavity, which~     rarely requires the help of a general or visceral surgeon.~      An alternative to laparotomy is the laparoscopic placement of the peritoneal catheter in~     VPS. Retrospective series have since shown the safety of this procedure and suggested an~     advantage of laparoscopic VPS in terms of operation duration, length of hospital stay and~     the rate of distal (and thus potentially overall) shunt dysfunction.~      The evidence concerning the effect of laparoscopic surgery for VPS placement is so far based~     on non-randomized studies, in which a selection bias may have influenced the outcomes.~   "
100692|NCT01739166|"~     Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and~     Policy Program (MEDTAPP), the Child Health Excellence Center - a University-Practice-Public~     Partnership (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target~     areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity;~     and 3) lead screening. These topics represent critical public health issues for Ohio's~     children.~      The study is based on strong evidence that interventions are needed to improve practice in~     the target areas and that achieving these goals represents fundamental improvements in child~     health care that would reduce morbidity and costs. The approach for the study involves a~     trained Practice Facilitator (PF) working with multiple pediatric and family medicine~     practices to create change tailored to individual practice preferences and methods of~     operation.~      Our overall hypothesis is that a university-community consortium, utilizing evidence-based~     methods (involving education plus a facilitated, practice-tailored approach) will increase~     the rates of targeted services in primary care practices.~   "
100693|NCT01739153|"~     The main objective of the current study is to examine whether a high intake of regular-fat~     cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of~     either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on~     fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin~     sensitivity is investigated.~      To do this, a randomized crossover intervention study with 3x14 days full diet periods~     (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between~     the diet periods there will be at least 14 days of wash-out where the subjects eat their~     habitual diets. Fasting blood samples will be drawn before and after the diet periods, and~     also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total~     feces is collected the last 5 days of each diet period.~   "
100694|NCT01739140|"~     This is a study to better understand how a yoga intervention helps improve symptoms in~     people with chronic low back pain. This study will be a 12-week intervention of about 24~     participants with chronic low back pain where all individuals will receive weekly yoga~     classes and instructions for home practice. The purpose of this study is to collect~     feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH~     study.~   "
100695|NCT01739127|"~     The purpose of this study is to compare abdominal weight gain and fat distribution in people~     taking aripiprazole versus risperidone or quetiapine, to people not taking any of these~     antipsychotic medications.~   "
100696|NCT01739114|"~     To determine if respiratory support at birth guided by RFM decreases BPD.~   "
100697|NCT01739101|"~     Many women and men are at risk for sexual transmitted infections and unwanted pregnancies~     and have unrealistic family planning intentions and insufficient knowledge of health~     promoting lifestyle prior to conception. Without sufficient support from the health care~     system this can lead to negative consequences. The aim of our study was to investigate if~     the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge~     of reproduction and particularly knowledge of folic acid intake prior to pregnancy.~     Secondary aims were to evaluate the influence on women's family planning and to further~     explore how women experienced the Reproductive Life Plan-based counselling.~   "
100698|NCT01739088|"~     In 2012, infants having surgery for congenital heart disease have a high survival. The~     investigators are now focused on improving how sick these infants become after surgery~     (short term outcomes) and their later neurodevelopment (long term outcomes). During heart~     surgery, cardiopulmonary bypass (CPB; the heart-lung machine) takes over heart function~     while the surgeon repairs the heart disease. During this surgery there are periods of time~     when the amount of blood going to the heart and brain is lower than usual, called~     ischemia. Once the surgery is finished the blood going to the heart and brain is increased~     to normal again, called reperfusion. This ischemia-reperfusion can cause injury to the~     heart, brain, and other organs, affecting the short and long term outcomes in these infants.~     Adult studies have shown that a short time of ischemia to the legs for 5-10 minutes [the~     legs are not damaged by a short time of ischemia, unlike the heart or brain], before severe~     ischemia to another distant vulnerable vital organ [like the heart or brain], can protect~     this other vital organ from ischemia-reperfusion injury. This is called remote ischemic~     preconditioning (RIPC). Our objective is to test whether RIPC before heart surgery can~     improve the recovery of the heart and brain after heart surgery in newborn babies with~     congenital heart disease. The investigators will test whether RIPC will result in lower peak~     lactate and troponin levels on the day after heart surgery. Lactate levels are a marker for~     how much the different tissues of the body suffer from ischemia-reperfusion injury. Troponin~     is released from damaged heart during ischemia-reperfusion. In our trial infants will be~     randomized to RIPC or control. This means each baby has an equal chance of being in one~     group or the other. The intervention group will have RIPC before surgery; the control~     group will not. The investigators hope this trial will lead to a larger study to test if~     RIPC results in fewer days on a breathing machine after surgery, lower mortality, and higher~     scores on neurodevelopmental tests at 2 years of age.~   "
100699|NCT01739075|"~     The purpose of this study is to determine whether a novel non-invasive method to estimate~     coronary blood flow (FFRct) is applicable to evaluate the functional significance of~     coronary stenoses in non-culprit vessels in a population of patients with recent STEMI~     (ST-elevation myocardial infarction) and multivessel disease. The diagnostic performance and~     reproducibility of FFRct as well as the qualitative and quantitative correlation between~     FFRct and the regional coronary blood flow will be examined.~   "
100701|NCT01739049|"~     Malaysia has increasing challenges in lifestyle related diseases, which is related to eating~     habits and disorders. According to the National Health & Morbidity Survey in 2011; it was~     reported the prevalence of obesity is 15.1% in 2011; or 2.5 million of the population,; an~     increase of 7/9% when compared to the 14% prevalence in 2006. Binge eating is a symptom~     described in various eating disorders. It is an under-diagnosed medical condition closely~     linked to higher body mass index (BMI) or obesity as well as personality psychopathology,~     psychiatric and psychological disturbances. Meta-analysis has demonstrated that extremely~     strict restriction in dietary calorie and fat intake is needed to achieve meaningful weight~     loss. Appetite and satiety are influenced by extremely complex central and gut-related~     hormonal systems which modulate the regulation of food intake Centrally acting hormones~     include Neuropeptide Y (NPY), agouti gene-related peptide, orexin which are~     appetite-stimulating, melanocortins and alpha-melanocortin-stimulating hormone which promote~     satiety.~      Gut-related peptides include ghrelin secreted by the stomach and the duodenum has orexigenic~     (appetite stimulating) effect; leptin secreted by adipose tissue has anorexic (appetite~     inhibiting) effect, cholecystokinin, glucagon-like peptide-1 (GLP-1) secreted by the~     proximal gastrointestinal tract which has slight anorexic effect, and peptide YY (PYY).~      Appetite and obesity have also been commonly related to stress and may influence~     binge-eating episodes. Previous studies have demonstrated that high stress hormone cortisol~     is associated with increased appetite and cravings, with preference for high carbohydrate~     content, thus leading to weight gain.~      In the previous study performed by our group on 738 normal subjects who were staffs of the~     Ministry of Health, Putrajaya, we found a prevalence of 19% binge eating behaviour, 83% of~     whom were either obese or overweight.~      GLP-1 analogue used for the treatment of type 2 diabetes and is also shown to produce and~     maintain weight loss. Liraglutide, which provides a supra physiological amount of GLP-1 may~     cause appetite inhibition thus may benefit in reducing binge eating. The aim of this study~     is to closely observe the extensive profile of neuropeptide Y, ghrelin, leptin and GLP-1,~     influenced by a standard meal in binge eaters in comparison to non-binge eating controls. In~     addition, we aim to determine the association between binging and the respective~     appetite-related hormones and also cortisol. Finally we will also be assessing the efficacy~     of novel hormonal treatment of Liraglutide in reducing binge eating.~   "
100702|NCT01739036|"~     This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the~     safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost~     vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged~     between 18 and 45 years.~      To determine the efficacy of each of two combinations of heterologous prime-boost~     immunisation strategies:~        1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS~        2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1~      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology~     and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility~     in Southampton, UK. The malaria challenge will take place at the insectary at Imperial~     College (Infection and Immunity Section) in London, UK.~   "
100703|NCT01739023|"~     The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC)~     transplantation in subjects with subacute SCI.~      For humans with subacute SCI, we hypothesize that axons might show improved function if~     myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation~     may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic~     effects.~   "
100704|NCT01739010|"~     The purpose of this study is to investigate the long term outcome of patients who receive~     hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia~     has been used for certain patients with spinal cord injury for the past two years. This~     study will collect data from vital signs and examinations while the patient is in the~     hospital and also when they follow up as an outpatient after they are discharged or go to a~     rehabilitation center. This data will then be analyzed and compared only to historically~     published data from previous studies. The aim of this investigation is to determine if~     intravascular hypothermia results in a beneficial outcome for patients with spinal cord~     injury.~   "
100705|NCT01738997|"~     Although balloon dilatation is the primary treatment for benign dysphagia, information about~     the optimal inflation time is lacking. The aim of the current pilot study was to compare 10~     seconds inflation time, with 2 minutes inflation time, regarding the efficacy~   "
100706|NCT01738984|"~     This Phase II Small Business Technology Transfer(STTR) project will develop and test the~     effectiveness of an interactive web program optimized for use on a Internet connected~     television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women~     with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos~     demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together~     exercise videos personalized to their fitness level, form of exercise, and the choice to~     actively exercise with her baby or alone. The primary health goal of the MomZing Program is~     to increase home-based Moderate to Vigorous Physical Activity (MPVA) minutes per week in new~     mothers and to maintain their exercise increases over time as their baby grows.~      The investigators hypothesize that women that use the MomZing Program will have greater~     increases in physical activity and fewer will return to cigarette smoking or alcohol use,~     compared to women who use a standard mommy and me exercise DVD.~   "
100707|NCT01738971|"~     Pharmacists do not provide immediate contraception to women after emergency contraception~     (EC); they can only give advice on local contraceptive services.~      The investigators wish to establish the following 2 pharmacy- based interventions in NHS~     Lothian, designed to increase uptake of effective contraception as soon as possible, after~     EC~        1. Pharmacists would provide one packet of progestogen-only pills, giving women one month~          to arrange an appointment with contraceptive services.~        2. Rapid access to a family planning clinic upon presentation of the empty EC packet.~          Women would be seen as a 'walk-in' and contraception provided.~      If feasible, these interventions could reduce unintended pregnancies.~      Participating pharmacies will be randomised to provide one of the interventions, or standard~     care (verbal/written advice on local contraceptive services).~      Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to~     participate in the study that will involve them consenting to contact by telephone 6-8 weeks~     after EC by the researcher, to evaluate the interventions in terms of :~      (i) determine women's experiences/ views of the interventions and control. (ii) determine if~     women have commenced effective contraception and if not , reasons why.~      A subset of 12 women will also be invited for in-depth interview to collect more detailed~     qualitative data on their EC experience.~      The investigators also wish to (iii) explore pharmacists views on the interventions~      Data from this pilot will enable the investigators to determine whether a larger multisite~     study is feasible. The aims of a larger study being to determine if either of the two~     interventions being tested result in an increased proportion of women using effective~     ongoing contraception compared to the control.~   "
101258|NCT01731730|"~     The objectives of this proof of concept study are to evaluate the safety and preventive~     analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in~     patients undergoing unilateral total knee arthroplasty.~   "
100708|NCT01738958|"~     Clinical trials in children and adults have suggested that daily consumption of probiotic~     lactic acid bacteria can reduce caries risk and caries development in primary teeth in~     preschool and stop root caries in the elderly. However, it is not known whether probiotic~     bacteria can affect the increased porosity in young permanent teeth in children and~     adolescents with many cavities.~      It can be difficult to measure the increased porosity of the enamel by tooth decay, but this~     can be done using quantitative laser fluorescence (QLF). The method is based on visible~     light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of~     red and green color tones and the dominant color of the enamel is green. Increased porosity~     of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of~     the mineral can be quantified by means of a corresponding software.~      The purpose of this study is to investigate the effect of a daily supplement of probiotic~     lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis~     is that the mineral content will not differ from baseline in either the test group or the~     placebo group.~   "
100709|NCT01738945|"~     In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most~     prevalent underlying disease of people in developed countries. A wide range of studies have~     been carried out, from various points of view, to understand the progress of renal~     dysfunction in diabetic nephropathy.~      Fibroblast growth factor 23 (FGF-23) is a primary regulator of renal phosphate excretion.~     FGF23 is inversely associated with the GFR, a relationship underlying a fundamental~     mechanism for maintaining serum phosphate constancy during CKD progression. Such an~     adaptation may have deleterious trade-offs because, independently of serum phosphate, high~     FGF23 signals a high risk of death in ESRD patients. Some studies showed that there is~     relationship between FGF-23 levels and proteinuria in CKD patients.~      There is no data about the effects of calcium channel blocker on FGF23 levels in diabetic~     patients with proteinuria. The aim of this study was to find out whether the beneficial~     effects of calcium channel blocker in diabetic proteinuria has any relation with the~     alteration of FGF-23 levels. The investigators searched for the effects of calcium channel~     blocker amlodipine on the clinical and laboratory parameters of diabetic patients with~     proteinuria.~      The investigators registered the study 'The effect of renin angiotensin system Blockage~     (RAS), calcium channel blocker and combined drugs on TWEAK, PTX3 and FMD levels in Diabetic~     Proteinuric Patients with Hypertension' (ClinicalTrials.gov Identifier:NCT00921570). The~     investigators will use the samples of the some patients for this study. The investigators~     also registered the study 'FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric~     Patients' (ClinicalTrials.gov Identifier: NCT01703234). The investigators will combine these~     two registered studies (NCT00921570 and NCT01703234) in one study.~   "
100710|NCT01738932|"~     The purpose of the study is to investigate the possible association between low levels of~     MBL and the development of endometriosis~   "
100711|NCT01738919|"~     Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the~     distal phalanx, with or without fracture.~      Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is~     controversial. There are to our knowledge no randomized controlled trials comparing~     splinting and surgical treatment with extension block technique.~      The aim of this study is to compare splinting and surgical extension block fixation of~     mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative~     treatment with splinting is comparable to surgical treatment concerning functional outcome,~     and may even reduce the complication rates.~      The original protocol was designed to include participants with non-subluxated and~     subluxated mallet finger fractures. However this study only included participants with~     non-subluxated fingers.~   "
100712|NCT01738906|"~     Rationale~      It has been shown in several studies that alcohol increases subsequent food intake. However,~     moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the~     Western world, where palatable food is highly available, food reward may play an important~     role in food intake. Alcohol consumption is known to stimulate neurotransmitters important~     for food reward and may therefore stimulate the reward response on a subsequent meal. This~     may lead to higher food consumption than when no alcohol is consumed. It is hypothesized~     that the reward response of food or beverages can already be generated when food or~     beverages are sensed in the mouth, because oral nutrient sensing is known to induce a~     satiety response (i.e. the cephalic phase response). Moreover, taste buds directly signal~     brain areas closely connected to the reward areas in the brain.~      Primary objective~        -  To determine whether moderate alcohol consumption influences subsequent food reward, as~          measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood~          parameters related to reward.~      Secondary objectives~        -  To determine whether food reward is different when food is consumed than when food is~          sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking',~          and salivary and blood parameters related to food reward.~        -  To determine whether moderate alcohol consumption influences subsequent food reward~          differently when food is consumed than when food is sensed in the mouth, as measured by~          questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters~          related to food reward.~   "
100713|NCT01738893|"~     The objective of this study was to confirm if two formulations of gabapentin (capsules) are~     bioequivalent.~      Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product~     Nerotin® 300 mg (Pfizer). One capsule was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-55~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug~     concentrations in blood.~   "
100714|NCT01738880|"~     In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to~     reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported~     to cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to~     insufficient fluid replacement for perioperative loss can also result in metabolic acidosis~     by lactic acid accumulation. However, the guideline for perioperative fluid management has~     not been yet established. The investigators hypothesized that intraoperative fluid~     management according to SVV(Stroke Volume Variation)could reduce perioperative metabolic~     acidosis compared to those by CVP(Central Venous Pressure). Therefore, the study is trying~     to determine if intraoperative fluid administration based on SVV could reduce metabolic~     acidosis when compared with CVP in patients undergoing craniotomy due to brain tumor who~     receive 0.9% normal saline as main fluid regimen.~   "
100814|NCT01737567|"~     Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of~     chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band~     imaging enables endoscopists to accurately describe the pit pattern of adenomas. By~     comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any~     comparable advantage to using one or the other for lesion detection and assessment.~   "
100715|NCT01738867|"~     A total of at least 48 healthy subjects with a history of social drinking will be recruited~     into this single-centre, randomized, double-blind, cross-over study. Subjects will be~     genetically stratified to result in equal numbers of A118G 'AA' homozygotes (n=24) and A118G~     'G' carriers (n=24).~      Subjects will participate in all three treatment periods and will be randomized to receive~     each of the following for 5 days: Treatment A: Placebo, Treatment B: Naltrexone (NTX) 50 mg~     once daily (25 mg once daily for the first two days) and Treatment C: GSK1521498 10 mg once~     daily. A washout period will be of at least 14 days between treatments. Subjects will return~     for a follow-up visit 7-10 days after the final treatment session washout period has been~     completed.~      Subjects will attend the clinical research unit on days 1, 2, 3, 4 and 5 to monitor safety~     and tolerability for both drugs. Subjects will attend the clinical unit on days 4 and 5 for~     a two day assessment, using a series of pharmacodynamic measurements known to be sensitive~     to the effects of GSK1521498 and/or NTX: Functional brain response to alcohol and food cues;~     plasma cortisol; hedonic and consummatory eating behaviors; subjective response to an~     ethanol challenge; experimental pain threshold; and cognitive tests of attention bias~     towards alcohol and food cues.~   "
100716|NCT01738854|"~     The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway~     with modification. The parameters about airway sealing such as oropharyngeal leak pressure~     (OLP) and leakage volume are important markers of efficacy and safety when using the~     supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal~     mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at~     various intracuff pressure in children.~   "
100717|NCT01738841|"~     This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in~     routine practice in children aged 12 months to 12 years living in the Philippines.~   "
100718|NCT01738828|"~     The GLOBAL study is an international multi-center, prospective study designed to enroll up~     to 10,000 consecutive eligible subjects who are clinically referred for coronary CT~     angiography for assessment of suspected coronary artery disease (CAD).~      The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in~     patients phenotyped using advanced imaging modalities of atherosclerosis.~   "
100719|NCT01738815|"~     The goal of this study is to test whether the drug valproic acid can cause changes in~     bladder tumors that might inhibit their growth.~   "
100720|NCT01738802|"~     This study is evaluating the impact of antioxidant supplements on blood sugar control and~     cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2~     diabetes. The investigators hypothesize that daily supplementation with a multiple~     micronutrient formulation containing dietary and endogenous antioxidants in combination with~     usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.~   "
100721|NCT01738789|"~     An adnexal mass is the most common indication for gynaecological surgery . Pre operative~     characterization is crucial and a scoring system would be useful to standardize the imaging~     report and thus, improve patient management. Recently, our center developed the first MR~     scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and~     reproducible (1). Our objectives are to perform an external prospective validation of this~     scoring system, to evaluate its potential impact on therapeutic strategy and to test its~     reproducibility.~      This is a prospective large multicenter study. All patients with a sonographically~     indeterminate adnexal mass referred for MR imaging will be consecutively included in each~     center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior~     and one junior radiologists independently analyze the different MR criteria to characterize~     adnexal masses. The MR report will be issued as standard and the patient will be managed~     accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The~     classification will be compared to the reference standard as defined below. The~     reproducibility of the classification will be tested between the junior and the senior~     radiologist. After anonymisation, images will be analyzed by another senior radiologist of~     another center blinded from any clinical or ultrasonographical data and correlated with the~     reference standard.~      Reference standard: Reference standard will be surgical procedure with histology or standard~     clinical follow-up depending on most appropriate routine practice.~      Sample size: The sample size was computed to ensure a power of at least 90% (with a~     two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would~     have a different PPV. It would thus be necessary to have at least 569 patients classified as~     SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and~     assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up,~     1340 patients will be included in this study to insure a probability of at least 95% to~     obtain the aforementioned number of patients in each score category. The inclusion period~     will last 18 months (extension for a period of 12 months) and monitoring will continue for 2~     years.~      Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system~     for Adnexal Masses. Radiology 2013, May;267(2):432-43.~   "
100722|NCT01738776|"~     Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the~     low BMI per se that increases risk of hip fracture or if specific micro-nutrients~     contribute. The investigators want to elucidate this aspect in a case control study studying~     micronutrients in serum and bone turnover markers of hip fracture patients compared with~     controls of the same age.~   "
100723|NCT01738763|"~     The purpose of this study was to assess the acute effects of increasing doses of pinitol on~     glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after~     consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.~   "
100724|NCT01738750|"~     This protocol examines choice where it pertains to choosing between two standard methods for~     appendectomy, laparoscopic or open procedures, and the affect that cost of the~     appendectomy has upon choice.~      Children admitted with a diagnosis of uncomplicated appendicitis will be consented to~     participate in a study in which the patient can choose between laparoscopic or open~     appendectomy procedures. Those that agree to review a consent form will be randomly placed~     into one of two groups. The two groups consist of one in which the consent form includes~     cost information for each operative procedure in the comparison between the procedures,~     and the other group receives a consent form that does not include cost information for each~     operative procedure. Both groups also view a short, group specific, computerized~     presentation that describes each procedure.~      The hypothesis is that those patients given a choice between two similar surgical procedures~     and are provided with cost information will more often choose the less expensive surgical~     procedure than those that do not have information related to the cost of the surgical~     procedures.~   "
100746|NCT01738464|"~     This research study seeks to provide more insight as to how the microbiome affects or is~     affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC),~     Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms~     (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often~     related and are poorly understood, and treatment is often not helpful. The goal of this~     study is to explain pelvic pain characteristics and causes by studying microbiomes of~     healthy people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major~     depression.~   "
100725|NCT01738737|"~     Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by~     2030 the prevalence of symptomatic OA could reach 30% of the population above 60 years. It~     is associated with significant morbidity being one of the most common causes of joint pain,~     functional disability and compromised quality of life. This randomised controlled trial will~     investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as~     monotherapy and in combination, on pain, quality of life, function, mobility, knee range of~     motion (KROM) and hamstring length in participants with knee OA.~      This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA~     and will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching~     exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch,~     LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will~     be three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide~     laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the~     monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of~     seven exercises completed over 24 sessions. The control group will receive a booklet.~      The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included~     quality of life assessed by Western Ontario and McMaster Universities Arthritis Index~     (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG),~     KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The~     statistical method will follow the principles of per-protocol analysis.~   "
100726|NCT01738724|"~     The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma~     volume and its associated symptoms to the same extent as gonadotropin releasing hormone~     (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs~     already in use.~   "
100727|NCT01738711|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease of unknown cause~     for which there is no effective medical treatment. The main symptoms are increasing~     breathlessness and cough which can significantly impact on quality of life (QOL) often~     leading to anxiety and depression. The focus of disease management is shifting from~     pharmacological attempts to reduce disease progression to managing symptoms and a more~     holistic approach. Cognitive behavioural therapy (CBT) is increasingly used to treat anxiety~     and depression in chronic disease. Our investigators aim to determine whether CBT can reduce~     anxiety and depression related to symptoms and improve QOL in patients with IPF. This study~     will compare CBT intervention (Group 1) against standard treatment (Group 2). Patients will~     be recruited from a specialist IPF clinic - all patients attending with IPF who suffer from~     anxiety will be eligible to participate in the study. The study aims to recruit 30 patients~     (15 in each group). Patients will be randomly allocated into each group using an envelope~     concealment system. At entry a baseline visit will be conducted with information gathered~     regarding disease severity, hospital admissions, medication, symptoms (subjective and~     objective), quality of life and anxiety and depression using questionnaires and routine~     clinical tests. Patients will then receive CBT intervention (Group 1) or no intervention~     (Group 2). Patients receiving CBT will undergo a maximum of 6 (minimum of 2) individual~     therapy sessions. Follow up visits for both groups will be conducted at 3, 6, 9 and 12~     months with the same information gathered as at the baseline visit.~   "
100728|NCT01738698|"~     The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg~     are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).~   "
100729|NCT01738685|"~     Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy~     (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated~     with physical and emotional concerns. I propose to evaluate the feasibility and preliminary~     effectiveness of a behavioral intervention to facilitate problem identification, provide~     education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the~     intervention intends to empower women to engage in better self-care and seek out resources~     they need, which, in turn, will lead to better symptom management.~   "
100730|NCT01738672|"~     Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor~     epidural anesthesia rate by 15%.~      Specific Aim: To determine if nitrous oxide can be an effective alternative technique for~     the provision of labor analgesia at Magee-Womens Hospital.~   "
100731|NCT01738659|"~     The aim of the study was to verify the effects of moderate versus low sodium intake on~     pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue~     Doppler imaging in patients suffering from compensated heart failure.~   "
100732|NCT01738646|"~     It has been shown that bevacizumab has significant anti-tumor activity in patients with~     recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against~     malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics.~     Patients will be treated with a combination of bevacizumab and vorinostat.~   "
100733|NCT01738633|"~     Background: A recent systematic review showed that patients undergoing esophagectomy for~     cancer had scores of physical function, vitality and performance of health in general~     significantly lower than those obtained from the reference population. The analysis of the~     quality of life at six months follow-up showed that the total score and physical function~     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea~     and diarrhea were worse six months after esophagectomy. The objective of this study is~     therefore to assess the impact of esophageal resections for cancer on the quality of life of~     patients and to improve it through simple interventions of post operative care.~      The study is divided into two steps.~      This is step 2.~      At hospital discharge, patients will be randomized into 4 groups receiving respectively:~     nutritional and respirology counseling; nutritional counseling alone; respirology counseling~     alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at~     1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea),~     AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.~   "
100778|NCT01738035|"~     The objective of the study is to evaluate efficacy and safety of two different doses of~     NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of~     developing end-stage renal disease, under rigorous blood pressure control with an~     angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker~     (ARB).~   "
100734|NCT01738620|"~     Background: A recent systematic review showed that patients undergoing esophagectomy for~     cancer had scores of physical function, vitality and performance of health in general~     significantly lower than those obtained from the reference population. The analysis of the~     quality of life at six months follow-up showed that the total score and physical function~     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea~     and diarrhea were worse six months after esophagectomy. The objective of this study is~     therefore to assess the impact of esophageal resections for cancer on the quality of life of~     patients and to improve it through simple interventions of post operative care.~      The study is divided into two steps.~      This is step 1.~      Patients will be randomized into four groups receiving respectively: psychological~     counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders~     during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake~     rhythm disorders during ICU stay alone; or standard care. The primary end point are the~     items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score~     of the PSQI.~   "
100735|NCT01738607|"~     The primary aim of this study was to compare the effects of supplementation with one of~     three dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on~     fecal incontinence (FI), symptom intolerance, and quality of life in community-living~     individuals who have incontinence of loose or liquid feces. A secondary aim was to explore~     the possible mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool~     consistency, water-holding capacity or gel formation).~   "
100736|NCT01738594|"~     This randomized phase I trial studies the side effects and the best dose of carfilzomib when~     given together with or without romidepsin in treating patients with stage IA-IVB cutaneous~     T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib~     alone is more effective than when given together with romidepsin.~   "
100737|NCT01738581|"~     This study is exploring a new experimental procedure in dystonia called repetitive~     transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of~     the study is to determine whether repetitive TMS is effective as a treatment to reduce~     symptoms in dystonia as demonstrated by improved motor performance.~   "
100738|NCT01738568|"~     Aging is associated with a loss of brain function and conditions such as dementia and~     Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the~     progression of age related degenerative diseases. Aerobic exercise training can increase~     brain volumes and is associated with decreased risk for degenerative brain conditions.~     However, little is know about the changes that occur to brain metabolism with aerobic~     training and aging.~   "
100739|NCT01738555|"~     This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who~     received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited~     from it. This study will examine the safety and efficacy of the investigational HIV drug,~     amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and~     lopinavir/ritonavir for 36 weeks.~      Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg~     twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir~     (400 mg/100 mg twice daily) for additional 36 weeks.~   "
100740|NCT01738542|"~     A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind~     was performed in 30 male patients (50-60 years old) with Intermittent Claudication~     (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6~     months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a~     period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h)~     during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice~     daily/four weeks and 125 mg twice daily/eight weeks) or control group.~   "
100741|NCT01738529|"~     A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy~     (CLE) together with standard white light colonoscopy including inter- and intra-observation~     of patients with Crohn's disease.~   "
100742|NCT01738516|"~     Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes)~     allow for better analysis of local and global activity of the cerebral cortex, as compared~     with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the~     first clinical service in France equipped with such a system.~      Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential~     information (in the form of connectivity graphs) on cortical networks, either~     dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or~     spike-waves) and during seizures.~      So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling~     et al., 2010). However, since each method is highly sensitive to the type of model that is~     assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al.,~     2006), none of them has yet demonstrated its effectiveness.~   "
100743|NCT01738503|"~     This is an open-label study in treatment seeking opioid-dependent subjects for safety,~     tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of~     subcutaneous injections of depot buprenorphine after induction and stabilization of~     treatment seeking subjects onto Subutex.~   "
100744|NCT01738490|"~     The overall aim of the study is to investigate the Ponto wide implant considering; initial~     implant stability, stability over time, skin reaction and long term success when loaded at 3~     weeks post surgery. Patients' quality of life improvements following implantation will also~     be surveyed.~      More specifically the primary objective of this clinical study is to test the hypothesis~        -  The new Ponto wide diameter implant offers increased implant stability measured as ISQ~          (implant stability quotient) compared to the previous generation Ponto implant.~      And the secondary objective is to~        -  Investigate when in time implant stability is the lowest as the initial mechanical~          stability is gradually replaced by biological stability~   "
100745|NCT01738477|"~     The purpose of this follow-up study is to evaluate the persistence of antibodies against all~     the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to~     assess immunogenicity and safety of another dose of Boostrix, administered in this study.~     This protocol posting deals with objectives and outcome measures of the extension phase. The~     objectives and outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00109330).~   "
100747|NCT01738451|"~     This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and~     Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT~     interval [QTc] duration) as compared with placebo in subjects with V600 BRAF~     mutation-positive tumors.~      Each part of the study will consist of screening (14 days prior to the start of the study~     treatment), treatment and follow-up period (14 days).~      In Part 1 in Cohort 1 six subjects will receive GSK2118436 225 mg twice a day (BID) on study~     days 1 to 7 and a single 225 milligram (mg) dose on morning of Day 8. Based on the safety~     data of subjects in Cohort 1 subjects will be enrolled in Cohort 2 and the dose of~     GSK2118436 will be escalated to 300 mg BID. If the 225 mg dose of GSK2118436 is not well~     tolerated in Cohort 1 (i.e., 2 or more dose-limiting toxicities [DLTs]), then Cohort 2 of~     Part 1 will not be initiated and a dose of 150 mg BID of GSK2118436 will be administered in~     Part 2 of the study. In Cohort 2 six subjects will receive GSK2118436 300 mg BID on Study~     Days 1 to 7 and a single 300 mg dose on the morning of Day 8. Based on the safety data of~     subjects in Cohort 2 subjects will be enrolled in Part 2. If the 300 mg BID dose level of~     GSK2118436 is not well tolerated, then the highest tolerated dose will be selected for Part~     2 of the study.~      In Part 1 of the study the decision to proceed to the next cohort or Part 2 of the study~     will be based on the safety data of at least 6 evaluable subjects (<=1 DLTs during the 14~     days following the first dose of GSK2118436).~      In Part 2 of the study eligible subjects will receive a single dose of GSK2118436/placebo (4~     capsules of 75 mg/highest tolerated dose) orally on the first 2 days of the study followed~     by 2 doses daily for 6 days and a single dose on the 9th day. There will be 1 day when a~     placebo will be given.~      In both the parts of the study serial blood samples for pharmacokinetic (PK) analysis for~     GSK2118436 and its metabolites (GSK2285403, GSK2298683 and GSK2167542) will be obtained at~     the same time points on the first and last day of dosing (2nd day of dosing also included~     for Part 2). Safety electrocardiogram (ECG)s will be performed at several timepoints during~     the study. In Part 2 Holter ECG monitoring will be performed for 24 hours on the 1st, 2nd~     and 9th days of dosing.~   "
100748|NCT01738438|"~     In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in~     metastatic breast cancer. Data suggest that MET expression and activation are important for~     initiation and progression of triple-negative breast cancer (TNBC). We evaluated the~     efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases,~     including MET and VEGFR2, in patients with metastatic TNBC.~   "
100749|NCT01738425|"~     The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I~     clinical study are to evaluate the safety and tolerability of five (5) single and four (4)~     multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the~     pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80~     healthy, 18-50 years old male and female subjects. Moreover, the effect of food on the~     pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed~     with an integrated, adaptive approach which allows the evaluation of single and multiples~     doses of GIC-1001 in a progressive, overlapped fashion.~   "
100750|NCT01738412|"~     The purpose of this study is the validation of an Electroencephalograph based algorithm for~     detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.~   "
100751|NCT01738399|"~     The purpose of the study is to investigate the long-term (24 weeks) effects of coffee~     consumption on insulin sensitivity in insulin resistant individuals.~   "
100752|NCT01738386|"~     Background:~      - Frontotemporal dementia (FTD) is the second most common cause of early-onset dementia.~     Alzheimer s disease is the most common. Alzheimer s disease happens most often in the~     elderly, but FTD typically appears between 40 and 60 years of age. It also has a strong~     genetic component: Up to 40% of FTD cases are linked to positive family histories. Earlier~     diagnoses and genetic tests mean that people with FTD will spend more years in earlier~     stages of disease, aware that they have it. However, few studies have looked at the personal~     experiences or coping styles of people with FTD. Researchers want to interview people with~     FTD and their caregivers to understand their experiences with the disease. This information~     will help create better treatments and therapies for those affected by FTD.~      Objectives:~      - To study the experiences of persons with FTD and their primary caregivers.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with FTD.~        -  Primary caregivers (spouse or partner at least 18 years of age) of individuals who have~          been diagnosed with FTD.~      Design:~        -  Before FTD participants are recruited, a pilot study will test the interview questions.~          This pilot study will be given to people with Alzheimer s disease and their caregivers.~          It will study how well people with dementia understand the interview questions.~        -  FTD study participants will be recruited through dementia care centers.~        -  All participants will have in-person interviews. These interviews will take up to 1~          hour.~        -  Participants with FTD will answer questions about their experience with the disease.~          They will talk about their mental abilities, challenges, and coping strategies.~        -  Caregivers will answer questions about their experience in caring for someone with FTD.~          They will talk about their challenges and coping strategies. They will also talk about~          the person with FTD, and how aware they believe that the person is of the dementia~          symptoms.~        -  All participants will receive a small gift card as compensation for their time.~        -  No treatment will be provided as part of this study.~   "
100753|NCT01738373|"~     The aim of this registry is to provide information, in day-to-day practice, on Plerixafor~     prescription modalities in France, over a 13-month period in order to address the health~     authorities' request.~   "
100754|NCT01738360|"~     Primary objectives :~        -  To investigate the safety and the tolerability of ATO by IV infusions to patients with~          SLE,~        -  To determine the maximum tolerated dose of ATO.~      Secondary objectives :~        -  Evaluation of the clinical and biological response of the SLE to ATO,~        -  Time of relapse in case of positive response,~        -  Determination of the efficacy,~        -  Pharmacokinetic study of ATO.~   "
100755|NCT01738347|"~     To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the~     Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and~     participants with relapsing and remitting multiple sclerosis.~   "
100756|NCT01738334|"~     Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional~     subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an~     improvement of these deficits, and reduces symptoms of anxiety and depression. However, the~     studies that demonstrated these improvements did not use a control group, nor controlled the~     use of medication. In the present study the investigators will examine the effects of the~     mindfulness practices (same protocol of 8 weekly sessions used in the study that showed~     positive effects in this disorder) in the performance of adult patients and healthy people~     (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by~     validated questionnaires before and after treatment/standby.~   "
100757|NCT01738321|"~     To date, there are no data in the literature regarding changes in the intracuff pressure~     during prolonged surgical procedures. It is possible that the pressure will increase over~     time related to gas expansion during equilibration to body temperature. If this is the case,~     these patients may be at risk for tracheal damage. This is a prospective study to evaluate~     the changes in intracuff pressure over time during prolonged surgical procedures.~   "
100758|NCT01738308|"~     The goal of this study is to assess the benefits of Healing Touch, an energy based therapy~     on post-operative discomfort and the rate of recovery in children. The aims of this study~     are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence~     agitation/ emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's~     departure criteria, 6.) maladaptive behaviors 2 weeks following surgery & 7)readmissions for~     complications 2 weeks following surgery.~      This is a triple blinded randomized controlled trial with three parallel groups. 240~     subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care,~     the usual care plus a post-operative Healing Touch treatment, or the usual post-operative~     care plus a sham Healing Touch treatment done by an untrained research assistant. The~     participants & parents, the evaluators, and the principle investigator will be blinded to~     study group assignment.~   "
100759|NCT01738295|"~     The present proposal investigates the role of the cholinergic system (the neurotransmitter~     acetylcholine) in improving vision and visual attention. Vision results from a complex~     processing of particular stimuli of the visual field. Attention enhances and prolongs the~     neural representations of visual input in the visual cortex. It has recently been shown that~     attention in the visual cortex depends on cholinergic mechanisms. The action of~     acetylcholine in the visual cortex consists in enhancement of the responsiveness to~     thalamocortical inputs, depression of local neuronal connections or extrastriate feedback~     projections and induction of gamma synchronisation. The investigators hypothesize that these~     effects are associated with long-term changes in functional connectivity in the visual~     cortex, visual attention and visual learning (improvement of the visual capacities).~      In the present proposal, the investigators will test whether the administration of donepezil~     (Aricept, 5mg), a drug that increases the level of acetylcholine in the brain, will enhances~     the perceptual-cognitive abilities of young adult subjects. Perceptual-cognitive performance~     will be assessed in a multiple object tracking (MOT) task in a 3D automatic virtual~     environment. MOT is a task where observers are asked to maintain attentional focus on a~     limited number of preselected subgroup of elements in a dynamic scene. Multifocal~     attentional mechanisms are necessary to process the information. The task will be tested~     five time at one week interval to test whether donepezil and training improved the task~     performance of the subject, i.e. lead to perceptual learning. This study could help~     establish an intervention procedure to improve visual performance of subjects that need it.~   "
100760|NCT01738282|"~     The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo~     on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol~     dependent patients receiving Brenda therapy sessions.~   "
100761|NCT01738269|"~     Aim of this study is to provide specimens for establishing reference values of HE4 in an~     apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of~     Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to~     population of subjects who have signs and symptoms of various benign and malignant diseases,~     including ovarian cancer. This reference range will also be compared to the levels of HE4 in~     individual subjects who have been diagnosed with ovarian cancer and are being followed~     longitudinally for recurrence or progression of their disease.~   "
100762|NCT01738256|"~     The purpose of this study is to examine the effectiveness and applicability of different~     interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as~     psychological and physiological health variables are assessed. The interventions are based~     on the principles of cognitive behavioural therapy, and delivered either face-to-face, via~     mobile phone application, or Internet.~   "
100763|NCT01738243|"~     Thyroid eye disease (TED) is an autoimmune disease that affects the eye area. The disease~     presents with a variety of physical findings, including bulging of the eyes (proptosis),~     upper and lower eyelid retraction, and swelling/inflammation of the eye itself.~      The disease passes through two phases: active and inactive. The active phase lasts between~     18 and 24 months. During this phase, TED signs and symptoms generally worsen and then often~     improve. The inactive phase follows, during which the signs and symptoms of TED cease to~     improve and usually stabilize.~      Lid retraction is a cardinal sign of TED. In addition to potentially causing cornea damage~     due to improper lid closure, lid retraction is also very troublesome for patients due to its~     cosmetic appearance. The precise pathophysiology of lid retraction is poorly understood, but~     a leading hypothesis is that it occurs due to scarring and fibrosis in the muscles that lift~     the eyelid.~      Currently, the definitive treatment for lid retraction is surgery, which can be used to~     lengthen the lid itself or remove inflamed tissue from behind the eye, thus causing the eye~     to bulge less. In cases when patients first present to their physician with corneal~     ulceration or compression of the optic nerve, surgery may be performed immediately. However,~     in most instances, surgical procedures are delayed until the active stage of the disease has~     passed. Thus, most patients must endure the cosmetic and irritant symptoms of TED for up to~     two years.~      Hyaluronic Acid Gels (HAG) have been FDA approved for the treatment of facial rhytids~     (wrinkles). They are injected under the skin and work by increasing volume. Recently, some~     smaller retrospective research studies have shown that HAG is also effective in correcting~     upper and lower eyelid retraction in TED. Hence, HAG may be for patients with active stage~     TED. It is also thought that if employed early in active phase disease, HAG may also help to~     decrease the severity of associated symptoms and reduce the need for surgery.~      The purpose of the current investigation is to define the clinical utility of HAG correction~     of upper eyelid in active TED in terms of anatomic (lid position), quantitative (corneal dry~     eye signs) and qualitative effects (symptom severity and thyroid related quality of life).~   "
100764|NCT01738217|"~     This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess~     the faisability and the capabilities of fluorescence imaging in hepatic surgery, and~     specially to help the surgeon while performing liver surgery.~      This study will be performed on patient intended to undergo a liver cancer surgery.It will~     contain three steps, assessing the following items:~        -  Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical~          surgical conditions and validate the data obtained in the preclinical phase,~        -  Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic~          lesions,~        -  Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding~          per-hepatectomy.~           3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the~          third step.~      Patients will be followed during 4 weeks after the surgery.~   "
100765|NCT01738204|"~     In order to learn more about women's health issues that occur over the lifespan, the Women's~     Health Study: from Adolescence to Adulthood is building a biorepository and database. The~     biorepository collects, processes and stores samples (such as urine, saliva, blood, cells,~     tissue and peritoneal fluid) until they are needed for research. The database contains~     de-identified information about our study participants. The biorepository and database are~     being created to serve as a resource for researchers from Boston Children's Hospital,~     Brigham and Women's Hospital and outside institutions.~   "
100766|NCT01738191|"~     The purpose of this study is to determine the safety and effectiveness of a drug called~     atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine~     (ATM) is an approved drug currently on the market for the treatment of attention deficit. It~     works to increase the amount of norepinephrine (a chemical in the brain that helps keep us~     awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration~     (FDA) to be used in the treatment of PD.~   "
100779|NCT01738022|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Models to study~     mechanisms of airway collapse have been proposed. However, these models have not been tested~     in the human upper airway. Gas density and viscosity are different gas properties that~     influence upper airway collapse and are variables of different models. In this study,~     subjects will breathe gas mixtures of different densities and viscosities for brief periods~     of time in order to test those models.~   "
100767|NCT01738178|"~     Parkinson's disease is a common neurodegenerative disorder in which patients experience~     progressive motor disability and many disabling non-motor symptoms. Recent studies have~     consistently found that people who do not use caffeine are at higher risk of developing~     Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.~      In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the~     motor manifestations of disease. There have been other lines of evidence that have suggested~     caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg~     BID vs matching placebo for motor and non-motor aspects of disease. This will be in three~     stages. In the first six-month stage, medications will be held constant, to see whether~     caffeine does have motor benefits. Then we will perform a four-year extension stage to~     define if the effects of caffeine persist (or even magnify), and to see if caffeine helps~     reduce dose of other PD meds and/or prevents their side effects. Finally, we will finish~     with a six-month stage in which we will place all patients on caffeine - this will allow us~     to assess caffeine's use in later disease, but more importantly, will assess whether early~     use of caffeine produces long term changes beyond its immediate effects.~   "
100768|NCT01738165|"~     The purpose of this pilot study is to collect data on the safety and effectiveness of the~     KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.~   "
100769|NCT01738152|"~     The purpose of this study is to see whether it is feasible to conduct a study to determine~     if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.~      This study aims to look at whether or not HyaloGYN® is effective in women with a history of~     hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen~     deprivation following their breast and endometrial cancer treatment.~   "
100770|NCT01738139|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ipilimumab and imatinib that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Imatinib is designed to bind to certain proteins on the tumor cells, which may prevent the~     cells from growing.~   "
100771|NCT01738126|"~     This K01 application is designed to prepare the applicant with the skills necessary to~     establish an independent research program on pain--related processing in the cerebellum.~     Although pain studies using functional imaging in humans consistently find cerebellar~     activation, the role of this structure during pain is unknown. In such studies, speculation~     regarding the cerebellum's function during a painful event is often influenced by its~     reputation as a coordinator of motor function, though animal studies have indicated that it~     may also modulate the neural encoding of noxious stimuli. The candidate has published work~     that indicates a functional dichotomy in the way the cerebellum responds to experimental~     pain in healthy subjects and neuropathic pain patients. This suggests that the cerebellum~     has been overlooked as a potential pain processing area, and research into this area could~     lend invaluable insight into the basic physiological circuitry involved with pain and its~     modulation.~      The hypothesis of this project is that the cerebellum serves as an integrator of aversive~     stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience~     that distinguishes the perception of pain from the appreciation of innocuous sensory~     stimulation. A human trigeminal model of experimental pain will be used, as all the~     pain--‐related circuitry involved can be imaged along with the cerebellum at the same time.~     The specific aims are (1) to map cerebellar activations related to sensory coding of noxious~     stimuli and to correlate functional activity with anatomical connectivity using functional~     magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish~     between pain and its anticipation based on cerebellar responses and connectivity; and (3) to~     determine whether physical pain and aversive images engage similar circuitry in the~     cerebellum. To accomplish these aims, the candidate will need to expand his background in~     fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become~     proficient in DTI analysis, and learn the white matter connectivity to and from the~     cerebellum. The research environment at McLean Hospital and the other affiliates of the~     Harvard Medical School system will provide the candidate with the resources to reach his~     aims within 4 years.~   "
100772|NCT01738113|"~     The Ilizarov external fixator is an external skeletal fixator that is used to stabilize or~     lengthen the limb bones. Bone lengthen bone occurs through mechanical distraction on the~     long axis of the bone, thus the method of lengthening is called distraction osteogenesis.~     This method has been shown successful. Unfortunately, it has also been associated with a~     substantial number of complications.~      Muscle shortening and persistent weakness are among the most common complications seen in~     this procedure. Muscle shortening usually occurs in strong muscle groups such as the planter~     flexor muscles, as a result of strength imbalance between the opposing muscle groups.~     Shortening may persist for more than a year after the removal of the fixator and may require~     surgical intervention. Fortunately, muscular shortening can be prevented by splinting and~     physiotherapy in the form of stretching and strengthening exercise and functional training.~      The use of different exercises in rehabilitation can help accomplishing different~     therapeutic goals. Thus, the choice to use one or the other should depend on the desired~     treatment goals. Weight bearing (CKC) and non weight bearing (OKC) exercise has been~     incorporated into rehabilitation; however, the effects of these two types of exercises~     particularly on muscle flexibility and mechanics have never been studied systematically.~      Therefore, the purpose of this is to compare the effects of OKC and the CKC exercise on~     muscle strength, architecture and flexibility.~      General Hypothesis:~      The use of open kinetic or closed kinetic chain exercises will have no different effects on~     muscle function or internal organization during tibial distraction osteogenesis by~     Ilizarov's method Specific hypotheses~        1. There will be no difference between the effects of OKC and CKC on muscle flexibility.~        2. There will be no difference between the effect of OKC and CKC exercises on muscle~          strength.~        3. There will be no difference between the effect of OKC and CKC on the internal~          organization of muscle specifically the pennation angle, muscle thickness and fiber~          length.~        4. There will be no difference between the overall of OKC and CKC exercise on the~          functional performance of patients.~   "
100773|NCT01738100|"~     A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint~     trial. Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be~     randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After~     emergent coronary angiography, patients who have thrombolysis in myocardial infarction~     (TIMI) flow grade <2 in coronary angiogram will be randomized again, to either bolus~     intracoronary injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be~     stratified by infarct location (anterior vs. non-anterior), and morphine use for pain~     control before study enroll (for only intracoronary morphine).~   "
100774|NCT01738087|"~     The study is aimed to assess the dose proportional total systemic exposure (when the~     administration is without the activated charcoal) to B17MP (active metabolite of BDP) and~     its lung bioavailability (when the administration is with the activated charcoal) after~     single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.~      At the same time, the study will assess if the lung deposition and the total systemic~     exposure to Formoterol is affected by increasing doses of BDP.~   "
100775|NCT01738074|"~     Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe~     rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus~     genetic reassortment vaccine.~   "
100776|NCT01738061|"~     The study was aimed to evaluate the effectiveness of a multidimensional worksite~     intervention program to reduce the severity of metabolic disorders in older workers in~     Taiwan.~   "
100777|NCT01738048|"~     A cross sectional study to determine the prevalence of persistent pain after reconstructive~     surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated~     with mastectomy without reconstruction.~   "
100780|NCT01738009|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Some studies have~     shown that there is progressive narrowing of the pharyngeal airway across breaths during~     expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause~     of PEN is unknown. The investigators will test if lung volumes and low respiratory drive~     play a role in PEN.~   "
100781|NCT01737996|"~     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics~     of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with~     faldaprevir in healthy male and female subjects.~   "
100782|NCT01737983|"~     The purpose of this study is to evaluate in patients with cystic fibrosis the effect of~     Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of~     both upper respiratory and gastrointestinal tracts.~   "
100783|NCT01737970|"~     This research proposal concerns a study to monitor the effects of chemotherapy on breast~     cancer tumour and peritumour stromal cells using ultrasound (US) elastography (also known as~     strain imaging).~      Many cancer treatments currently being developed are targeted; that is they exploit~     particular biological processes in specific cancer cell types to disrupt tumour growth.~     Being able to monitor the efficacy of these typically high-cost drug therapies is essential~     both for the best patient outcome as well as offering economical benefits to the health care~     system and much needed insight into future drug development.~      Ultrasound provides a relatively inexpensive, non-invasive means for imaging cancers, and~     has been used widely in breast cancer diagnosis for many years. Its role in therapy~     monitoring has been suggested but has not been well explored. The purpose of this proposal~     is to explore this potential in more depth.~      It has been identified that significant interaction takes place between tumour and stroma~     through all stages of tumour growth; this complex relationship is an ongoing topic of~     research. Fibrotic changes occur during tumour growth and are also a quintessential process~     of healing. Indeed, fibrosis is a common after effect to chemotherapy in many forms of~     cancer. Elastography is an established imaging technique (based on ultrasound or MRI) which~     can estimate the relative stiffness of tissues in vivo and is thus well-suited to monitor~     these particular biological processes.~      This elucidates the main hypothesis of this project: fibrosis, cancer cell necrosis and~     inflammation may all contribute to a measurable response in elastography. These changes to~     the tissue composition can be imaged over a course of a patient's treatment to assess the~     response to chemo/hormonal therapy.~      The ultimate project goals are to develop a clinical tool (based on ultrasound elastography)~     to improve treatment management in addition to offering a better biological understanding of~     tumour/stroma behaviour.~   "
100784|NCT01737957|"~     To determine the safety and efficacy of a single session of low-fluence panretinal~     photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of~     low-fluence PRP will be safe regarding the progression of macular edema and the presence of~     adverse events, and will efficiently induce regression of neovascularization.~   "
100785|NCT01737944|"~     Pharmacokinetics (PK) study~   "
100786|NCT01737931|"~     To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines~     for application site reaction (ASR) after administration of SPM 962 in healthy subjects~   "
100787|NCT01737918|"~     Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We~     repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if~     solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments~     (PUL) need to be repaired.~   "
100788|NCT01737905|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single~     dose study in 24 pediatric patients (4-11 years old) with asthma.~      The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2)~     Study Visits. All study subjects must be properly consented, under adult supervision, and~     screened against the inclusion and exclusion criteria, at the Screening Visit.~   "
100789|NCT01737892|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled~     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous~     epinephrine, in healthy male and female adult volunteers. The current study is designed to~     complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004~     PK. Safety of E004 will also be evaluated.~   "
100790|NCT01737879|"~     The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can~     be converted to epoetin alfa by using a predefined conversion table while achieving a stable~     hemoglobin.~   "
100791|NCT01737866|"~     A phase 1, open-label study in subjects with normal renal function and subjects with various~     degrees of renal insufficiency, including patients with end-stage renal disease (ESRD)~     requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423~     in subjects with various degrees of renal insufficiency, including patients with end-stage~     renal disease requiring hemodialysis.~   "
100792|NCT01737853|"~     The objective of this phase IV clinical multi-center trial will be to compare the efficacy~     and safety of Ganforti® versus Krytantek®, using a cross-over design during a six month~     period (including a one-month wash-in period) in POAG and OH patients.~   "
100793|NCT01737840|"~     The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine~     in treating patients presented with dyspepsia to the emergency department.~      The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating~     patients presented with dyspepsia to the emergency department.~   "
100794|NCT01737827|"~     This study is to find out if INC280 is safe and has beneficial effects in patients with~     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.~   "
100795|NCT01737814|"~     The purpose of this study is to evaluate whether MST-188 can reduce the duration of~     vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also~     evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a~     recurrence of VOC. Additionally, this study will compare the development of acute chest~     syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.~   "
100796|NCT01737801|"~     Time to perform lung function test after chest physiotherapy in cystic fibrosis.~      The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital~     capacity).~   "
100797|NCT01737788|"~     The aim of this study was to evaluate the effect of cervical occlusion versus no cervical~     occlusion in women with cervical cerclages.~   "
100798|NCT01737775|"~     Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative~     respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies~     have been published. The aim of this prospective study is to compare the achievement of~     diaphragmatic function depending on the type of surgery (abdominal and head and neck~     surgery).~   "
100799|NCT01737762|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      This research is being done to compare the efficacy of HP802-247 plus compression therapy~     against Vehicle plus compression therapy in achieving complete wound closure over the~     16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.~      At least 250 subjects will participate. The study is going to be conducted in approximately~     50 sites in the United States and Canada.~   "
100800|NCT01737749|"~     The primary objective of the study is to check the ability of Neurokeeper's algorithm system~     to detect and monitor changes in cerebral electrophysiological parameters as compared to~     clinical evaluation in patients undergoing cardiac surgery.~      The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations~     as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control,~     single center study.~      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.~   "
100801|NCT01737736|"~     The primary objective of the study is to validate an EEG base algorithm system to detect and~     monitor changes in cerebral electrophysiological parameters as compared to clinical~     evaluation in patients undergoing Carotid Endarterectomy.~      The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection,~     time from clinical deterioration to algorithm asymmetry detection Thi study is a~     prospective, open label, single arm, self control, single center study.~      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.~   "
100802|NCT01737723|"~     The purpose of this study is Collecting data for an Electroencephalograph based algorithm~     for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.~   "
100803|NCT01737710|"~     Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with~     severe itching. People who have atopic dermatitis often have complications from skin~     infections; these can include eczema herpeticum after herpes simplex virus infection or~     eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from~     skin infections and may therefore respond differently to vaccinations.~      A new flu vaccine which is injected into the skin instead of into muscle has recently been~     approved by the Food and Drug Administration for vaccination of the general population~     including patients with atopic dermatitis. This new vaccine has been shown to work as well~     as the vaccine which is injected into muscle when tested in people without atopic~     dermatitis. The main purpose of this study is to compare how people with atopic dermatitis~     respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis.~     The second purpose is to look at how people with atopic dermatitis respond to the new~     vaccine which is injected into the skin compared to the vaccine which is injected into~     muscle.~   "
100804|NCT01737697|"~     Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo~     control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 -~     6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).~      Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more~     effective than placebo control (alternative hypotheses) in maintaining normokalemic levels~     (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between~     each ZS dose and respective placebo controls (null hypotheses).~   "
100805|NCT01737684|"~     This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618)~     administered to participants with moderate hepatic insufficiency and healthy participants~     matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild~     hepatic insufficiency.~   "
100806|NCT01737671|"~     The goal of this clinical research study is to learn if it is safe to receive methotrexate~     through the fourth ventricle of the brain in patients with brain tumors.~      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their~     growth and spread throughout the body. This may cause the cancer cells to die.~   "
100807|NCT01737658|"~     Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.~   "
100808|NCT01737645|"~     This study is to determine if there is a rise in eye pressure, when patients are placed in a~     position where the head is lower than the rest of the body during long surgeries.~   "
100809|NCT01737632|"~     The fundamental objective of this study is to compare the effectiveness of an intensive~     in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted~     residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to~     delineate the mechanisms of change for each treatment. The study targets dually- diagnosed~     adolescent drug abusers recommended for residential treatment.~   "
100810|NCT01737619|"~     The goal of this clinical research study is to compare positron emission tomography/computed~     tomography (PET/CT) scans and sentinel lymph node mapping in finding lymph nodes that have~     endometrial cancer.~   "
100811|NCT01737606|"~     The new technical of ultrasonic exploration of this project purpose to validate the~     measurement of cerebral pulsatility by a new way called Fast Cerebral Pulsatility Imaging~     (FCPI).This will somehow determine the natural history of cerebral pulsatility during~     development adult to old age~   "
100812|NCT01737593|"~     Emergence agitation (EA) occurs in up to 67% of pediatric patients after anesthesia for~     bilateral myringotomy tubes (BMT, ear tubes). The goal of this study is to find out~     whether acetaminophen given well before surgery can decrease pain and therefore, decrease~     emergence agitation better than acetaminophen given shortly before or during surgery. EA can~     be dangerous for the patient because it may be hard to monitor their vital signs during an~     important phase of recovery, they may injure themselves, may require the presence of extra~     staff, and it can be very distressing to the parents. Causes of EA are not well understood,~     but it can be worsened by pain. 70% of patients undergoing BMT experience pain that needs~     treatment. Intranasal fentanyl, a strong analgesic, has been shown to decrease EA, but often~     ends up in dose-dependent nausea and vomiting. In previous studies and in common practice,~     acetaminophen is given either 30 minutes before induction of anesthesia or immediately after~     induction. The peak analgesic effect of acetaminophen is 60-120 minutes. Since the procedure~     is generally completed in 5-10 minutes, the therapeutic effect of acetaminophen may not be~     present upon emergence from anesthesia.~      The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to~     emergence can decrease EA in patients undergoing BMT. Patients would be randomized to one of~     three groups: Control will receive acetaminophen rectally while under anesthesia (standard~     practice), Group 1 will receive acetaminophen 10 mg/kg at 60-120 minutes prior to surgery,~     Group 2 will receive acetaminophen 20 mg/kg at 60-120 minutes prior to surgery. All groups~     would also receive a dose of intranasal fentanyl during the surgery, which is standard~     practice. Patients would be observed in the recovery room at various time points for~     evidence of EA and pain.~   "
100813|NCT01737580|"~     The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper)~     resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors~     65-75 years of age.~   "
100815|NCT01737554|"~     Catheter occlusion and dysfunction are common complications of central venous access device~     (CVAD) use in children with cancer and hematologic disorders. These events can lead to~     interruption of therapy and may require device removal and replacement. Attempts to clear~     occlusion can cause device fracture.~      There is a clear link between catheter occlusion and other serious complications including~     bloodstream infection and intravascular thrombosis.~      There is evidence that catheter occlusion or dysfunction may be preceded by subclinical~     catheter narrowing, which could be detected by accurate measurement of catheter resistance.~      This study aims to observe and describe the feasibility and results of catheter resistance~     monitoring (CRM) over time with the aim of prospectively identifying patients at high risk~     of catheter occlusion.~      If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity~     for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection~     or thrombosis.~   "
100816|NCT01737541|"~     This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will~     be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment~     with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral~     hemorrhage.~   "
100817|NCT01737528|"~     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world~     outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by~     The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT~     Registry is designed to monitor the safety and efficacy of this new procedure for the~     treatment of aortic stenosis.~   "
100818|NCT01737515|"~     Despite advances in surgical technique, preoperative patient evaluation and post-operative~     care, elective colorectal surgery carries a risk of mortality of approximately 2% and a~     morbidity rate ranging from 20-40%. Risk prediction is important for two reasons: it informs~     decision-making in individual cases before surgery (part of informed consent) and allows the~     comparison of actual outcome with predicted outcome. A number of scoring systems for~     assessing risk of death after surgery have been developed. They vary from simple scores~     based on a few variables to highly complex mathematical models requiring detailed data~     input. Recently, the Association Française de Chirurgie conducted a multicentre study to~     develop and validate a 4-item predictive score of mortality after colorectal resection which~     has good predictive value and is simple to use.~      Although many surgeons associate obesity with adverse outcomes, recent large, well-designed~     studies have been unable to show that obesity (defined as Body Mass Index (BMI) >30) is an~     independent risk factor for major morbidity or mortality after general abdominal surgery.~     Recently abdominal obesity (waist measurement >102cm in men and >88cm in women) has been~     shown to have better correlation with cardiovascular disease than BMI and is strongly~     associated with a clustering of risk factors for cardiovascular disease and diabetes~     (insulin resistance, hyperglycaemia, hypertension, dyslipidaemia and abdominal obesity)~     known as the metabolic syndrome. Waist circumference and waist/hip ratio are measures of~     abdominal obesity that correlate with the amount of intra-abdominal rather than subcutaneous~     or general body fat and may be a better measure of the risk of intra-operative complications~     and post-operative morbidity following abdominal surgery than BMI.~      The study will be prospective and multicentred, with 28 participating units in Belgium,~     France, Switzerland and Sweden. The coordinating centre will be UCL St Luc. The study will~     start on 1st September 2008 and will aim to include a minimum of 1000 patients. Consecutive~     patients undergoing elective colorectal resectional surgery for cancer or diverticulitis~     will be included. In addition to normal preoperative assessment, waist and hip circumference~     will be measured before surgery and specific data will be collected on intra and~     post-operative complications and mortality. Data will be recorded using an encrypted,~     anonymous database using variables carefully selected to assess short and long term~     outcomes. The study will be the first of its kind to investigate abdominal obesity as a~     predictive risk factor for colorectal surgery and will also be one of the biggest~     prospective studies of morbidity after colorectal surgery.~      The aims of the study are a) to assess if waist measurement or waist/hip ratio is a better~     predictive risk factor for complications or mortality after colorectal surgery than BMI, and~     b) if this measurement adds accuracy to the AFC score in risk prediction.~   "
100819|NCT01737502|"~     This phase I/II trial studies the side effects and best dose of auranofin when given~     together with sirolimus and to see how well it works in treating patients with lung cancer~     that has spread or other places in the body and cannot be cured or controlled by treatment~     or has come back after a period of time during which the cancer could not be detected.~     Auranofin and sirolimus may stop or slow the growth of lung cancer.~   "
100820|NCT01737489|"~     The purpose of this study is to determine if aural rehabilitation adds measurable benefit~     and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the~     study is designed to compare the efficacy of a commercially available aural rehabilitation~     program (LACE) and an electronic program which takes advantage of a traditional form of~     auditory training (NOOK) for cochlear implant users.~   "
100821|NCT01737476|"~     The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in~     treating attention deficit disorder in adults.~   "
100822|NCT01737463|"~     Endoscopic snare papillectomy (ESP) is an efficient treatment for benign tumors of the~     duodenal major papilla. But post-ESP pancreatitis is the most common and serious~     complication. Since one prospective randomized controlled trial showed that pancreatic duct~     stent placement reduced post-ESP pancreatitis, almost physicians have tried to place the~     pancreatic duct stent after EPS.~      The aim of this prospective, randomized, multicenter trial is to compare the rates of~     post-ESP pancreatitis in patients who did or did not prophylactic pancreatic duct stent~     placement. Consecutive patients who were to undergo ESP were to randomized to pancreatic~     duct stent placement group (stent group) after endoscopic snare papillectomy or to no~     pancreatic duct stent placement group (no stent group).~   "
100823|NCT01737450|"~     The aim of this study is to determine the activity, to assess the safety and tolerance of~     BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under~     platin and cetuximab-based chemotherapy.~   "
100824|NCT01737437|"~     A previous study demonstrated topical lidocaine spray on the larynx and the trachea is~     effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In~     clinical practice, blind oropharyngeal application of lidocaine without aiding direct~     laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and~     trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to~     correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during~     spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on~     direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.~   "
100825|NCT01737424|"~     To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in~     healthy male subjects~   "
100826|NCT01737411|"~     The purpose of this study is to determine if pelvic surgery can improve urge urinary~     incontinence in women more than standard medical treatment.~   "
100827|NCT01737398|"~     The purpose of this study is to evaluate the efficacy and safety of IONIS-TTR Rx given for~     65 weeks in patients with Familial Amyloid Polyneuropathy~   "
101288|NCT01731327|"~     This study will explore the drug behavior and safety following single doses of tofacitinib~     modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.~   "
100828|NCT01737385|"~     This study examines the microcirculation of the caput humeri after proximal humeral~     fracturation using O2C light probes.~      During the operation the blood circulation is measured at four points (tuberculum majus,~     tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes~     are a none-invasive technique of measuring blood flow, velocity and oxygen concentration.~     The data is analysed in respect to the fracture type according to the classification of~     Neer.~      Valuable additional information for the correct treatment and prognosis of humeral fractures~     is expected.~   "
100829|NCT01737372|"~     This study will look at the blood and cerebrospinal fluid of consented participants who~     either have early stage multiple sclerosis (clinically isolated syndrome) or who have later~     stage (secondary progressive multiple sclerosis), or participants who do not have any~     neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group~     differences.~   "
100830|NCT01737359|"~     This is a double-blind Phase 2a study to test the safety and efficacy of an investigational~     HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once~     daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently~     failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be~     randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice~     daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine~     300 mg twice daily.~      The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300~     mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug,~     but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who~     received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to~     enroll in the 36-week open-label study.~   "
100831|NCT01737346|"~     The combination therapy of temozolomide and radiation has been established as the standard~     therapy for the initial treatment of glioblastoma. However, the prognosis for patients with~     recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is~     no efficient and standard care at the time of recurrence or progression following~     temozolomide administration. Recently, many clinicians have reassessed the efficacy of~     second-line chemotherapeutic agents such as nitrosoureas for the treatment of~     recurrent/refractory glioblastoma. It is very important that the effect of the agent is~     sustained and the adverse effect is reduced to preserve the quality of life in recurrent~     settings. We have realized that the clinical features of Korean patients are very different~     from those of foreign patients. Therefore, it is mandatory to develop the new strategy for~     the treatment of Korean patients. We modify the PCV chemotherapy in the dose and~     administration schedule of CCNU and procarbazine to reduce the side effect, especially~     hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU~     and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of~     vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC~     chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the~     first multicenter trial for glioblastoma patients in Korea.~   "
100832|NCT01737333|"~     Collection of data from different sites regardless of whether they use standard or tailored~     protocols for the application of high concentration iodinated contrast agents to assess if~     the individually patient-adapted protocols result in a similar diagnostic image quality.~   "
100833|NCT01737320|"~     The investigators plan an open label randomized controlled trial to compare short-course~     antibiotic therapy (<=7 days) versus longer treatment (>7 days). The investigators will~     include hospitalized patients with gram-negative bacteremia. The investigators primary~     objective is to investigate the safety and efficacy of short-course antibiotics.~   "
100834|NCT01737307|"~     The purpose of this study was to investigate the effect of Fluoride varnish and Casein~     Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and~     salivary characteristics in patients under chemotherapy.~   "
100835|NCT01737294|"~     This non-interventional study will evaluate the efficacy, tolerability, health related~     quality of life and use of health resources associated with QUTENZA treatment when QUTENZA~     is used in standard clinical practice.~      The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into~     subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic~     back pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic~     pain; and 'other' neuropathies.~   "
100836|NCT01737281|"~     Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates~     of smoking-related morbidities compared to the general Veteran population. Smoking cessation~     treatment delivery in the VA typically depends on a visit from a health care provider. In~     this study, investigators will use information within the electronic medical record to~     identify all smokers with a mental health diagnosis at a VA health care facility and~     proactively reach out to enroll them in an intensive tobacco cessation treatment program.~     This approach could be generalized to other behaviors and provides a novel method to improve~     the health of an entire population of patients.~   "
100837|NCT01737268|"~     FK949E will be administered to elderly bipolar disorder patients with major depressive~     episode for 52 weeks. Its safety, efficacy, and plasma concentration change will be~     evaluated in an open-label manner.~   "
100838|NCT01737255|"~     This study is aimed at exploring the use of whole body MRI for early cancer detection in~     TP53 mutation carriers and population controls, with the hypothesis that more cancers will~     be detected in the TP53 mutation carrier group. A secondary end-point will be the number of~     incidental findings detected and subsequent investigations required. A series of~     questionnaires will be used to assess the psychological impact of screening on both the~     study and control group.~   "
100839|NCT01737242|"~     The UKGPCS was set up to find genetic alterations which occur in patients who have prostate~     cancer.~      A man's risk of developing prostate cancer increases if he has a first-degree relative~     (father or brother) who was diagnosed with prostate cancer at a young age. This is why we~     are looking for men who are affected at a young age or who have a family history of prostate~     cancer, since it is more probable that these prostate cancers are due to an inherited~     genetic cause rather than an environmental cause.~      We also ask all men who come to the Royal Marsden Hospital to be treated for prostate cancer~     if they would like to take part in the study so that we can also look to see if we find~     genetic alterations in older men, and those who do not have a family history of prostate~     cancer.~   "
100840|NCT01737229|"~     TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of~     RD94 in patients needing endodontic care, medical device class III.~      SPONSOR:~      SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33~     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91~      Reference protocol: 09/001~      PRODUCT NAME: Biodentine™ (RD94)~      MEDICAL DEVICE:~      Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application :~     one single time~      DEVELOPMENTAL PHASE: not applicable (medical device class III)~   "
100841|NCT01737216|"~     Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients~     with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination~     with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain~     in the lumbar spine and total hip.~   "
100842|NCT01737203|"~     The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without~     water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under~     fasted conditions.~   "
100843|NCT01737190|"~     The aim of the study is to examine the effects of two different levels of PEEP on subsequent~     standard recruitment maneuver.~   "
100844|NCT01737177|"~     This is a prospective, multicenter phase II trial designed to evaluate the safety and~     activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients~     with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a~     maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to~     24) for those responding to the induction.~   "
100845|NCT01737164|"~     Aging is a major risk factor for the development of type 2 diabetes (T2DM). Approximately~     50% of subjects aged ≥65 have diabetes or impaired glucose tolerance, a pre-diabetic state.~     Purpose: In the proposed study, the investigators will test the hypotheses that the decrease~     in fat oxidation that occurs in muscle from older human subjects is secondary to an~     age-mediated reduction in AMPK signaling, in vivo, and that upregulating AMPK signaling~     through exercise training will result in (and correlate with) increased fat oxidation,~     reduced intramyocellular lipids, and improved insulin action.~   "
100846|NCT01737151|"~     This clinical trial studies stereotactic body radiation therapy in treating patients with~     low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
100847|NCT01737138|"~     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with~     chronic kidney disease and resistant hypertension~   "
100848|NCT01737125|"~     The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes~     all the gravity, forecast and complexity of ankle fracture treatment. It's classically~     described and known by radiological point of view, but in static incidence and from~     anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our~     study will use high spatial-resolution MRI acquisition to obtain the best possible~     definition of DTFJ but especially it will be associated with MRI acquisition in movement,~     using typical fast sequences  TrueFISP  and FLASH which will allow a precise modelling~     of joint physiological movements and biomechanics on healthy subjects by a not invasive~     method. This analysis will be made on a simple movement of flexion and extension, the other~     possible movements of the ankle being blocked what corresponds to the clinical situation of~     an osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed~     ® It will be associated aneffort test  with the reproduction of subjected joint of a load~     with MRI joint movement control This test will be made with an ankle fixed to 90 ° of~     flexion what reproduces the post-operative clinical situationThe meditative data will be~     associated with an anatomical biomechanical study of ankles presenting a syndesmosis injury~     repaired according to the classic protocol using in our department, by comparing them with~     the data of the literature to optimize techniques repair of this joint. Indeed there is not~     gold standard surgical technique Main PurposeTo understand, observe, analyze and quantify~     the joint movement during a simple movement of ankle extension and flexion, and during a~     simulation of axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose -~     Modelling the DTFJ- Modify the post-operative care with hypothesis that load does not lead~     abnormal movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition).~     - Validate our technique of repair of this joint by comparing the data MRI with anatomical~     mechanical tests~   "
100849|NCT01737112|"~     This is an open-label SPECT/CT (single photon emission computed tomography / computed~     tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in~     evaluation of lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight of~     99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion~     of lung cancer. Visual and semiquantitative method will be used to assess the whole-body~     planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.~   "
100850|NCT01737099|"~     The purpose of this study is to investigate the efficacy and safety of DHA-O to lower~     elevated triglyceride levels in healthy adults with hypertriglyceridemia.~   "
100851|NCT01737086|"~     Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration~     due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc~     depletion in infants, and zinc is recommended by the World Health Organization in the~     treatment of acute gastroenteritis in infants and children. However, the efficacy of zinc~     supplementation to children with acute gastroenteritis in more affluent settings is unclear.~     Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several~     studies to shorten the duration of diarrhoea by about 24 hours, and also to attenuate~     symptom severity. If probiotics are given within 60 hours from onset of symptoms the~     duration can be reduced even more. Lactobacillus reuteri (L. reuteri) has been shown to~     reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In~     these studies L. reuteri was proven to have clinical effect on diarrhoea of both bacterial~     and viral (rotavirus) origin. In humans, L. reuteri strain DSM 17938 has recently been shown~     to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children~     with acute gastroenteritis treated in hospital.~      The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM~     17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing~     the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or~     moderate dehydration when introduced early (within 48 hours) after the start of~     gastroenteritis associated diarrhoea in an out-patient setting.~      A prospective, randomized, double blind, controlled study with parallel groups will be~     performed. Assuming a difference of 25% between groups in the primary outcome of prevalence~     of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an~     attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71~     subjects in each arm.~      Parents contacting the health care telephone enquiry agency, the primary care emergency~     unit, the paediatric emergency unit, all at the Umeå University Hospital or the well-baby~     care centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed~     that they may participate in the present study and they will be given contact information to~     the research nurse for this activity. A home visit by study personnel will then be done for~     evaluation of eligibility, information, collection of informed consent and delivery of study~     product.~      Data collection points will be at the recruitment visit in the patient's home, and by~     telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be~     referred to the primary health care facility or the outpatient clinic of the Department of~     Paediatrics, Umeå University Hospital.~   "
100872|NCT01736813|"~     The surface molecule CCR5 is found on tumor cells within liver metastases of colorectal~     cancer. Inhibition of this molecule leads to a reduction in growth signals for tumor cells~     and subsequent slowed or halted tumor growth. The agent for the inhibition of CCR5 has~     already received FDA approval for treatment of HIV and has shown little side effects and~     toxicities even on long term treatment. Therefore CCR5-inhibition has the potential of~     providing non-toxic tumor growth inhibition.~   "
100852|NCT01737073|"~     This study will enroll Veterans with chronic pain who have been receiving opioid medications~     (like methadone, percocet, oxycontin) on a regular basis for at least 3 months to treat~     their pain. The purpose of this study is to understand if two automated interventions that~     are delivered by phone can improve the safe and effective use of opioid medications and the~     physical functioning of Veterans with chronic pain who take opioid medications. One~     intervention, opioid monitoring, will include monthly automated calls to the enrolled~     Veteran to ask questions about their use of the opioid medications, pain relief, side~     effects, effect of pain on physical activity and mood and satisfaction with pain care. The~     other intervention, skills training, includes learning pain management skills using~     automated calls and a self-help book with weekly feedback calls from a nurse. Veterans who~     are enrolled in this study will be randomly assigned (by chance, like a flip of a coin) to~     receive either opioid monitoring only, self-management only, self-management plus opioid~     monitoring or a weekly automated phone call with wellness tips. Everyone enrolled in the~     study will complete questionnaires about their pain and other pain-related information at~     the beginning of the trial, after the interventions are completed 12 weeks later, and 3 and~     6 months after treatment ends.~   "
100853|NCT01737060|"~     To investigate the assumption that reversed shoulder prosthetic replacement will give a~     better functional outcome compared to open reduction and internal fixation with an angular~     stable plate in displaced proximal humeral fractures.~   "
100854|NCT01737047|"~     The purpose of this study is to identify medical conditions that may cause particular~     problems to individuals receiving care for HIV infection over the age of 50. In addition, as~     the effects and potentially the side effects, of HIV medication may change with age, this~     study will also investigate the association between age and differing effects of~     antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in~     blood.~      Results from this study may inform future HIV treatment guidelines on how we monitor~     individuals with HIV infection. The results may also assist in the design of future studies~     for the treatment of diseases associated with ageing.~   "
100855|NCT01737034|"~     The catch-up fat phenomenon is an evolutionary conserved physiological response to a~     starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis,~     reduced body protein regain and an increase in fat mass above basal level during refeeding.~     Clinically, it characterises weight cycling in overweight patients which is associated with~     increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance,~     inflammation). In this project, the physiological, cellular and molecular mechanisms of this~     phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that~     refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat~     phenomenon and its sequelae. This translational research will provide comprehensive insights~     into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.~   "
100856|NCT01737021|"~     1. Evaluate the feasibility and acceptability of an information based intervention~          delivered to parents following their child's admission to paediatric intensive care;~        2. Evaluate the feasibility and acceptability of the study design and procedures;~        3. Explore the effects of the intervention on parent and child psychological outcomes 3-6~          months post discharge from PICU;~        4. Explore the effects of parental stress experienced during PICU admission on the~          effectiveness of the intervention;~        5. To provide data that, combined with results from other studies, could inform the sample~          size for a future multi-site RCT.~   "
100857|NCT01737008|"~     This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without~     chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck~     (SCCHN).~      Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a~     receptor called the epidermal growth factor receptor (EGFR). By blocking signals for cancer~     cells to grow, it is believed to stop or slow the growth of tumor cells.~      The dose escalation phase will find the best dose as well as determine the safety of~     dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion~     phase will further test the best dose determined in the dose escalation phase for response~     rate.~   "
100858|NCT01736995|"~     Research has provided support for the efficacy of cognitive-behavioral and family~     interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related~     problems. Despite support for these interventions, substantial heterogeneity in treatment~     outcomes and high relapse rates has been consistently found across studies. Such variability~     highlights the need for innovative strategies to broaden the impact and strengthen the~     durability of effects of adolescent substance abuse treatments. Over the past two decades,~     research has shown the positive effects of contingency management (CM) methods on reductions~     in substance use and other problem behaviors. When combined with evidence-based practices,~     emerging research suggests that CM integration may also be effective for adolescent~     substance abusers. The proposed Stage II efficacy trial examines the integration of CM with~     two empirically-supported interventions: group MET/CBT and FFT. By comparing two~     intervention modalities (group vs. family, the study provides a unique opportunity to~     examine the robustness of the effects of CM across established adolescent treatments, and to~     compare change mechanisms that may account for treatment outcomes. In the proposed research,~     substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group~     MET/CBT. Random assignment will also be used to determine whether or not youth will receive~     a CM condition that provides incentives for abstinence (i.e., clean urine screens) and~     treatment participation. The primary aim of the study is to examine the efficacy of an~     integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT~     and FFT, compared to these treatments without CM on drug abuse abstinence (a) during~     treatment (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e.,~     durability of effects). A second aim of the study is to evaluate the effects of CM on~     hypothesized mediators of the intervention effects in the MET/CBT and the FFT conditions.~     The investigators anticipate that the CM conditions, compared to the nonCM conditions, are~     more likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend~     and participate in treatment, and to complete homework assignments. The investigators will~     also examine the effects of the interventions on HIV-risk behaviors and expect that CM will~     demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.~   "
100873|NCT01736800|"~     The specific purpose of this study is to obtain data on safety and efficacy of combination~     chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid~     tumors. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and~     will receive 8 cycles of chemotherapy. The primary endpoint is the determinant median~     overall survival and progression-free survival of this regimen, time to progression of the~     brain metastases, and assessment of toxicity levels in this regimen.~   "
100874|NCT01736787|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of~     immunity. The investigators measured promotion of immunity parameters , including~     Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH,~     MCHC, PLT), and monitored their blood pressure.~   "
101289|NCT01731314|"~     This study investigates the learning and memory of pain.~   "
100859|NCT01736982|"~     Smoking cessation services are an unmet need among the homeless, who smoke at rates more~     than 3 times the national estimate; successful interventions in this underserved population~     have the potential for improving individual and public health. Contingency management (CM)~     is a behavioral intervention with efficacy in a number of substance use disorder~     populations, including smokers. However, no known studies have evaluated the effect of CM in~     homeless smokers. The investigators plan to examine smoking-related outcomes in homeless~     treatment-seeking smokers (N = 70) randomized to standard care smoking cessation~     (transdermal nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO]~     monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM)~     conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT~     use continuing through week 8. Participants in both conditions will meet with study staff up~     to twice daily on weekdays for biochemical verification of smoking status. Participants in~     the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤~     4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The~     investigators expect that participants randomized to CM will have better outcomes compared~     to those in standard care.~   "
100860|NCT01736969|"~     The purpose of this study is to determine whether a developmental formulation is~     substantially equivalent to the predicate device in the treatment of hypertrophic and keloid~     scars.~   "
100861|NCT01736956|"~     For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve~     fetal growth of left heart structures and thus improve potential for biventricular repair~     strategies after birth.~   "
100862|NCT01736943|"~     The purpose of this study is to determine whether bortezomib in combination with~     doxil/lipodox is effective in the treatment of Acute Myeloid Leukemia.~   "
100863|NCT01736930|"~     The purpose of this study is to evaluate an overnight system that will turn off the insulin~     pump automatically if the system predicts that a low blood sugar is likely. The study system~     includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic~     MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low~     blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous~     glucose monitor, (2) using a computer program on a laptop to predict what will happen to the~     glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the~     computer program predicts that low blood sugar will occur. We have tested this system~     overnight in the hospital and are ready to test the system in the home environment to learn~     more about how well it will work and to make sure that the blood sugar does not go too high~     when the pump shuts off.~      This study has several phases and will take about a month or a little more for a patient to~     complete. Patients will use the study system for about 5 days at home to show that the~     patient is able to use it correctly. After that, the patient will be asked to use the study~     system each night for an additional 3-4 weeks. During this time, the system will be active~     for two-thirds of the nights and not active for one-third of the nights. When the system is~     active and predicts that your blood sugar will become low, the insulin pump will shut off~     for up to 2 hours.~      The study will include 2 clinical centers in the United States.~   "
100864|NCT01736917|"~     The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV~     fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone~     will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and~     vomiting, compared to the results of our prior study of aprepitant. This study will be the~     first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin.~     This will be a single arm, phase II study. The investigators propose to utilize intravenous~     (IV) fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is~     anticipated that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for~     2-5 days after therapy. This study will test the value of fosaprepitant in this patient~     population.~   "
100865|NCT01736904|"~     The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in~     the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of~     wXELIRI is not less than FOLFIRI with tolerable toxicity.~   "
100866|NCT01736891|"~     The objective of this study is to evaluate the efficacy, tolerability, and safety of~     rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.~   "
100867|NCT01736878|"~     The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo~     in subjects with locally advanced medullary thyroid cancer (MTC). The primary study~     objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group~     with the placebo treatment group in patients with advanced MTC.~   "
100868|NCT01736865|"~     This research study in adults with established type 2 diabetes will test whether daily~     vitamin D supplementation affects how the body processes glucose (sugar).~   "
100869|NCT01736852|"~     The CRB study is designed to study the safety and effectiveness of the Cook Cervical~     Ripening Balloon (CRB) for the induction of labor in term and near-term patients with~     premature rupture of membranes (PROM).~   "
100870|NCT01736839|"~     In cystic fibrosis, there is a critical need for better predictors of treatment response.~     The investigators have identified a panel of white blood cell biomarkers which can be~     directly measured as a blood test in subjects with cystic fibrosis. These biomarkers predict~     reduction of airway inflammation and infection more accurately than lung function testing,~     in patients receiving intravenous antibiotic therapy. In the current study, we hypothesize~     that this panel of gene biomarkers which can be readily measured from peripheral blood will~     sensitively predict changes in inflammation when patients receive inhaled antibiotic~     therapy, specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study~     will have blood drawn before and after a month of inhaled Cayston, in order to test whether~     genes predict response to Cayston therapy more robustly than do standard measures such as~     lung function tests.~   "
100871|NCT01736826|"~     The primary objective of this study is to demonstrate that plasma concentrations of~     nucleosomes and free DNA differ between three groups:~        1. pregnant patients with complications typical of placental insufficiency or venous~          thrombosis (group P),~        2. healthy women (Group T1) and~        3. healthy pregnant women (Group T2).~   "
100886|NCT01736631|"~     We are doing this study to find out how well cognitive behavioural therapy for social phobia~     works in people with bipolar disorder, who also have social phobia.~   "
100875|NCT01736774|"~     The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache~     but other various frequent intermittent headache types (i.e. migraine and tension-type~     headache) in the elderly population. There has been no trial to date which has investigated~     the effectiveness of physiotherapy treatment specifically for older persons with various~     types of headache with associated neck pain and cervical musculoskeletal impairment. Thus,~     the purpose of study investigate the efficacy of physiotherapy treatment for older persons~     who have headache concomitant with neck pain and musculoskeletal impairment~   "
100876|NCT01736761|"~     For patients who are starting to take antiretroviral medication (to treat HIV) for the first~     time, there are now a variety of different medicines which may be taken together as a~     combination in order to form an effective treatment which suppresses the virus for prolonged~     periods of time. Currently, national guidelines recommend the use of two different drugs of~     one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as~     nukes) with a third drug from one of two other types (either a nonnucleoside reverse~     transcriptase inhibitor, known as an NNRTI or nonnuke, or a protease inhibitor, known as a~     PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are~     given in combination with a small dose of a second PI, ritonavir, which has the effect of~     boosting the levels of the active PI in the bloodstream.~      The investigators know from both research studies and patient experience in clinic that a~     combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing~     the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above.~     In this study, the investigators will observe the combination of two licensed antiretroviral~     medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus~     when given to patients who are commencing treatment for HIV infection for the first time.~     Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe,~     and are currently in standard clinical use.~      The study will monitor this treatment over the first 48 weeks. The investigators will also~     examine the levels of both drugs in the bloodstream during the first 4 weeks of starting~     this regimen, to confirm that they remain at levels which the investigators know to be~     effective against the virus.~   "
100877|NCT01736748|"~     The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and~     adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity,~     hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to~     promote physical activity and reduce sedentary time to improve childrens' cardiometabolic~     profile. To do so, the intervention relies on gathering data on mobility and physical~     activity using wearable sensors. These data provide a detailed picture of real-life~     conditions and physical activity levels, improving the health care professional's ability to~     tailor counseling. The investigators are presently in the implementation phase of this~     intervention.~   "
100878|NCT01736735|"~     This is a placebo-controlled study to determine the effect of CLP in heart failure subjects~     with fluid overload.~   "
100879|NCT01736722|"~     The Methodist Hospital Neurological Institute is conducting a clinical trial for patients~     suffering from Metastatic brain tumors. The objective for this study is to evaluate the~     safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance~     for the treatment of brain metastasis.~      Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure~     proper placement of the laser within the tumor. The tumor will then be heated by the laser~     and monitored by study physicians through the real-time MRI to see and control temperatures~     in the tissue. One in place, the thermal laser will then surgically remove the lesions.~     After the procedure, post treatment MR images will thenbe acquired for the determination of~     the effective treatment region.~   "
100880|NCT01736709|"~     The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013~     trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy~     adults aged 18-60 years old, and 60 healthy older people aged > 60 years.~   "
100881|NCT01736696|"~     This study was conducted in subjects with psoriasis to evaluate drug activity in this~     patient population by analysis of changes in psoriatic lesion biopsy characteristics. This~     subject population was selected to evaluate potentially relevant biological activity of~     CP-690,550 as well as assessing safety and pharmacokinetics.~   "
100882|NCT01736683|"~     The primary objective of this study is to determine a safe, tolerable and effective dose of~     sotatercept that results in the greatest frequency of improvement of anemia in patients~     diagnosed with low- or intermediate-1 risk MDS or non-proliferative chronic myelomonocytic~     leukemia (CMML).~   "
100883|NCT01736670|"~     Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available~     in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the~     relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.~     Unlike more potent steroid products, T Spray has no time limitations on its use; therefore,~     it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis,~     and contact dermatitis.~      In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas~     of the body. Its optional nozzle directs application of the medication to precise areas~     without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions~     on the scalp, back, intertriginous folds, large areas, or areas that require precise~     application would benefit from the T Spray formulation. In the time since the introduction~     of T Spray to dermatology, other topical corticosteroids have entered the market, but T~     Spray remains the only mid-potency corticosteroid available in a spray formulation.~      In a recently published open-label, non-comparator study involving 42 patients with chronic~     steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days.~     Improvement of lesions after one week of treatment was experienced by 85% of patients, and~     95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of~     patients reported an anti-pruritic cooling effect which was experienced upon application.~   "
100884|NCT01736657|"~     The purpose of this study is to evaluate the performance of the Spectra Optia system red~     blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants~     with sickle cell disease.~   "
100885|NCT01736644|"~     This study will compare the clinical outcomes for patients undergoing a total knee~     replacement using a bipolar sealer, the Aquamantys® System, as compared to standard~     electrocautery. Total blood loss during the hospital stay and knee mobility and discharge~     factors will be analyzed.~   "
100888|NCT01736605|"~     In this study we propose to explore the efficacy of massage therapy combined with meditation~     in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients~     will be randomized into 2 groups. The first group will consist of massage therapy on 3~     consecutive days starting on the 1st day after surgery. The second group will consist of~     massage therapy combined with meditation for 3 consecutive days starting on the 1st day~     after surgery. The effect of massage and massage combined with meditation on stress,~     anxiety, relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood~     and energy level will be evaluated by using three different surveys.~   "
100889|NCT01736592|"~     The purpose of the study is to examine the long term safety of an experimental gene transfer~     agent, SAR422459, designed to treat Stargardt Macular Degeneration.~   "
100890|NCT01736579|"~     The purpose of this long-term study is to provide additional evidence of safety and efficacy~     of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase~     3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg~     or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.~     Participants and investigators will be blinded to dose unless otherwise notified by the~     sponsor.~   "
100891|NCT01736566|"~     The MedSeq™ Project seeks to explore the impact of incorporating information from a~     patient's whole genome sequence into the practice of clinical medicine. In the extension~     phase of MedSeq we are attempting increase our participant diversity by increasing targeted~     enrollment of African/African American patient participants.~   "
100892|NCT01736553|"~     Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong~     preclinical evidence suggests that effective therapy must be delivered as early as possible~     to prevent progression of the disease. The primary study objective will be to identify~     prognostic and surrogate biomarkers of disease progression that will facilitate the~     execution of therapeutic SMA clinical trials in infants.~   "
100893|NCT01736540|"~     Iron, one of the most common elements in nature and the most abundant transition metal in~     the body, is readily capable of accepting and donating electrons. This capability makes iron~     a useful component of various, essential biochemical processes. Despite the essential role~     of iron, the excess of iron is toxic to the human body. It is critical for the human body to~     maintain iron balance, since humans have no physiologic mechanism for actively removing iron~     from the body.~      The development of iron overload occurs when iron intake exceeds the body's capacity to~     safely store the iron in the liver, which is the primary store for iron. Long-term~     transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is~     currently the most frequent cause of secondary iron overload.~      The mounting evidence regarding the mortality and morbidity due to chronic iron overload in~     transfusion dependent anaemias has led to the establishment of guidelines that aim the~     improvement of patient outcomes. Further prospective studies are warranted in order to~     assess the impact of iron overload in patients with acquired anaemias.~      In this study, non-invasive R2- and T2*-MRI techniques were applied to the liver and the~     heart, respectively, to complement the primary variable (serum ferritin) assessed in~     patients with various transfusion-dependent anaemias. The main objective of this study was~     to assess the prevalence and severity of cardiac and liver siderosis in patients with~     transfusional siderosis. This study was also aim to establish possible correlations between~     cardiac and liver iron levels with clinical effects in patients with different~     transfusion-dependent anaemias. Patients were eligible for enrollment irrespective of~     receiving chelation therapy or not (and irrespective of the chelating agent used).~   "
100894|NCT01736527|"~     To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical~     instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.~   "
100895|NCT01736514|"~     This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design~     study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive~     febuxostat, or allopurinol for subjects with gout.~   "
100896|NCT01736501|"~     A 10 minute baseline survey will be administered to parents of healthy newborn infants while~     in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25~     minute survey 3-24 months later. We will measure parents' attitudes and preferences related~     to genome screening of newborns. The specific aims of this study are:~        1. To investigate whether parents' opinions regarding genome screening of newborns change~          between the first 48 hours post-partum and 3-24 months post-partum.~           a. We hypothesize that there will not be significant differences between interest in~          genome screening results in the 48 hours post-partum compared to 3-24 months~          post-partum.~        2. To determine whether seeing hypothetical genome screening results affects parents'~          decisions regarding whether they would want genome screening for their newborn.~             1. We expect many parents to state initially (in the 48 hours post-partum) that they~               would elect to have genome screening for their newborn if it were available. In~               the follow-up survey, half of study participants will receive hypothetical~               scenarios in which they will need to struggle with the probabilistic and ambiguous~               nature of the information that could be derived from genome sequencing. We will~               examine whether this alters their preferences. We will also explore whether~               parents who receive hypothetical genome screening results scenarios are more~               likely to alter their preferences than parents who do not receive hypothetical~               scenarios.~   "
100897|NCT01736488|"~     The purpose of this study is to evaluate the antihypertensive efficacy and changes of~     neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response~     during exercise in essential hypertensive patients.~   "
100898|NCT01736475|"~     To assess efficacy and safety, including immunogenicity of BAX 855 administered as~     prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously~     treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK)~     parameters of BAX 855.~   "
100899|NCT01736462|"~     The objective of this study is to evaluate the effect on corneal endothelial cell density~     (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered~     QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.~   "
101363|NCT01730339|"~     The study will compare how well PF-06473871 works versus placebo in reducing skin scarring~     after scar revision surgery of existing breast scars. The study will also evaluate the~     safety of PF-06473871 in healthy adult subjects.~   "
100900|NCT01736449|"~     A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the~     surface of the cornea. Frequently, these pterygia will recur even after surgical resection.~     Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use~     of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this~     study is to compare the effects of wound healing and recurrence rates in postoperative~     bevacizumab versus pterygium excision alone.~   "
100901|NCT01736436|"~     It has been shown in preclinical experiments with bone marrow from patients with~     myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is~     expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients.~      APG101 might, therefore, be a valuable addition to current treatments of low- or~     intermediate MDS patients suffering from anaemia.~      Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic~     Scoring Scale (WPSS) can be included in this study.~      Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6~     months follow up phase.~      Primary objective of the trial is safety and tolerability of APG101; secondary objectives~     are~        -  Hematologic, cytologic and cytogenetic response rate using modified International~          Working Group (IWG) response criteria~        -  Incidence and time to leukemic progression at 37 weeks~        -  OS (Overall survival) at 37 weeks~   "
100902|NCT01736423|"~     To evaluate the efficacy and safety of YM060 once daily for female patients with~     diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52~     weeks).~   "
100903|NCT01736410|"~     To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in~     first-line HER2-positive advanced gastric cancer.~   "
100904|NCT01736397|"~     The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and~     effective treatment for the management of serum phosphorus levels and iron deficiency in~     anemic chronic kidney disease (CKD) subjects not on dialysis. Total length of treatment is~     approximately 12 weeks.~   "
100905|NCT01736384|"~     There is a variability in weight loss after gastric bypass surgery for obesity despite a~     standardised surgical procedure. This study aims to investigate if genetic markers can~     predict outcome after gastric by-pass surgery in treatment of obesity. The investigators~     will also study if adenovirus infection can influence the outcome after surgery. In a~     subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid~     and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as~     well as liver biopsies and whole blood are stored in a biobank. The same tissues will be~     collected from non-obese controls undergoing gallbladder surgery.~   "
100906|NCT01736371|"~     The aim in this study was to quantify the difference in cisatracurium and sufentanil~     consumption, and its recovery period, when patients are under balanced general anesthesia~     with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed~     loop computer control infusion. Investigators further investigated this effect on its~     recovery period and sufentanyl consumption.~   "
100907|NCT01736358|"~     Despite an overall reduction in the perioperative complication rate, post operative pain~     management after ureteroscopic removal of stones (URS) remains a major factor delaying~     discharge of patients. The investigators hypothesize that perioperative usage of intranasal~     ketorolac will provide a reduction in post operative opioid requirements, better post~     operative pain control, higher anesthesia satisfaction and faster recovery.~   "
100908|NCT01736345|"~     The overall goal of the proposed research is to evaluate psychosocial and behavioral~     outcomes (i.e.risks and benefits) of an innovative and efficient delivery model for genetic~     testing, telephone communication, as an alternative to in-person communication of genetic~     testing results to inform guidelines regarding the delivery of genetic information in~     clinical medicine.~   "
100909|NCT01736332|"~     Background:~      - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as~     poppy seeds) may cause a positive screening drug test. This might look like someone used~     illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are~     studying how the body handles chemicals that may test like illegal drugs and for how long~     they may be detected in the body. Blood, saliva, and urine samples will be collected. This~     study may help improve the effectiveness and accuracy of drug tests.~      Objectives:~      - To see how the body handles chemicals that may produce positive screening tests and how~     additional testing can eliminate positive drug tests from over-the-counter drugs and food.~      Eligibility:~      - Healthy volunteers between 18 and 65 years of age.~      Design:~        -  Participants are screened with a physical exam, medical history, laboratory tests, and~          ECG.~        -  This study involves an overnight stay on a secure research unit and 2 days of tests.~        -  On the first day, participants will take Vicks VapoInhaler (two inhalations in each~          nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing~          poppy seeds twice (at about 9 a.m. and 5 p.m.).~        -  On the morning of the second day, participants will take the Vicks VapoInhaler just~          once. They will be discharged around 5 p.m.~        -  On both days, participants will provide blood and saliva samples several times~          throughout the day. All of their urine will be collected during the 2 study days.~   "
100910|NCT01736319|"~     Background:~      - Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria.~     ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is~     becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of~     Cambodia, but not yet in other parts of the country. This has been shown by treating~     patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours,~     and calculating the rate of parasite clearance. The parasite clearance rate in response to~     ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance.~     Researchers want to study how effective ACTs are in different regions of Cambodia. This~     study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has~     become.~      Objectives:~      - To compare the prevalence of ACT-resistant malaria in western, northern and eastern~     Cambodia.~      Eligibility:~      - Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum~     malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.~      Design:~        -  Participants will be recruited from clinics and hospitals in three Cambodian provinces.~        -  Participants will be informed about the study and their consent to participate in the~          study will be obtained.~        -  A venous blood sample will be obtained from patients before treatment and used for~          laboratory experiments to measure parasite and patient factors that might affect the~          parasite clearance rate.~        -  Participants with malaria will be treated with dihydroartemisinin-piperaquine~          (DHA-PPQ), the standard first-line treatment for malaria in Cambodia.~        -  Treatment will be monitored with frequent blood samples obtained from a finger prick.~          The amount of malaria parasites in each blood sample will be counted and followed until~          they are no longer detectable.~        -  Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood~          samples will be taken at each visit to see if the parasites reappear after treatment~          with ACT.~   "
100911|NCT01736306|"~     Background:~      - At present, women do not have very accurate tests to inform of them of their personal risk~     of developing breast cancer. More information on the changes associated with both benign and~     cancerous breast lesions will help develop better risk information. Researchers have been~     looking at cells found in breast milk to study genetic changes related to breast cancer.~     However, most of these cell samples have been collected from white women. A new study wants~     to collect breast milk samples from African American women for further research. Comparing~     the results of genetic tests will help improve understanding of breast cancer risk in all~     women.~      Objectives:~      - To study genetic changes related to breast lesions, including breast cancer, in African~     American women.~      Eligibility:~      - African American women at least 18 years of age who are nursing a baby and who either have~     had or are being considered for a breast biopsy.~      Design:~        -  Participants will be screened with personal health questions.~        -  Participants will receive a box with sterile bottles for milk collection. They will~          collect two breast milk samples, one from each breast. They will also fill out a~          questionnaire about their medical history.~        -  The box with the samples and the questionnaire will be returned to the clinical center~          for study.~        -  After the box is returned, participants will be asked to provide a copy of the biopsy~          report for any breast biopsies they have had.~        -  There will be a followup phone call every year. Participants will provide health~          history information. This information will include whether they have been diagnosed~          with breast cancer in the previous year.~   "
100912|NCT01736293|"~     Background:~      - The ABCA4 gene contains a blueprint for the ABCA4 protein. When this protein is absent or~     faulty (such as in Stargardt s disease), waste material from dead cells collects in the eye.~     The waste material may cause other cells in the eye to die. This can lead to the loss of~     vision. Researchers want to look at blood and skin samples from people with ABCA4 gene~     mutations to study related eye diseases.~      Objectives:~      - To study eye diseases that are related to mutations in the ABCA4 gene.~      Eligibility:~      - Individuals at least 12 years of age who have ABCA4 gene mutations.~      Design:~        -  The study requires seven visits to the National Eye Institute clinic over 5 years. In~          the first year, there will be three visits. After the first year, participants will~          have one visit a year for 4 more years.~        -  Participants will be screened with a physical exam, full eye exam, and medical history.~          The eye exam will check eye pressure, light and color sensitivity, and retina function.~        -  Participants will provide a blood sample and a skin tissue sample for study.~        -  No treatment will be provided as part of this study.~   "
100913|NCT01736280|"~     Background:~      - Some research studies focus on digestive disorders, such as nutritional, gastrointestinal,~     and liver disorders. Researchers want to examine and treat people with digestive disorders~     in order to learn more about these disorders. They also want to study how digestive~     disorders run in some families. To do so, they will provide standard care to people with~     digestive disorders. They will also look at relatives of people with digestive disorders,~     such as parents, children, and siblings.~      Objectives:~        -  To examine and treat people with digestive disorders.~        -  To evaluate people with digestive disorders for research studies.~      Eligibility:~        -  Individuals of any age who have digestive disorders.~        -  Individuals at least 2 years of age who are first-degree relatives of the people with~          digestive disorders.~      Design:~        -  Participants will have at least one outpatient visit to the National Institutes of~          Health. The visit will last about 2 hours.~        -  All participants will be screened with a physical exam and medical history. They will~          also provide different samples for study. Samples may include blood, urine, and stool~          samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may~          be collected from adult participants.~        -  Participants with digestive disorders may be able to receive treatment through this~          study.~   "
100914|NCT01736267|"~     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)~     can improve hearing in persons who are deaf in both ears and are not candidates for cochlear~     implants.~   "
100915|NCT01736254|"~     The purpose of this study is to measure how much of the study drug (evacetrapib) gets into~     the blood stream and how long it takes the body to get rid of it when given with~     gemfibrozil. Each participant will receive gemfibrozil alone, evacetrapib alone, and both~     drugs in combination. There is no washout period between doses. The safety of both of the~     study drugs given together will be evaluated. Information about any side effects that may~     occur will also be collected. This study will last approximately 36 days.~   "
100916|NCT01736241|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3053102 in healthy participants. The study will also investigate how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it.~     Information about any side effects that may occur will also be collected. The study is~     expected to last approximately 8 weeks for each participant (up to 4 weeks from the~     screening visit to the administration of study drug and an additional 4 weeks of follow up).~   "
100917|NCT01736228|"~     The purpose of this study is to establish the efficacy and safety of xenotransplantation of~     DIABECELL [immunoprotected (alginate-encapsulated) porcine islets] in patients with~     established type 1 diabetes mellitus~   "
100918|NCT01736215|"~     The purpose of this observational study is to evaluate the predictors of response to~     erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in~     bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads~     in the body until it kills) related anemia (decreased number of red blood cells), receiving~     chemotherapy (treatment of cancer using drugs).~   "
100919|NCT01736202|"~     The development of type 2 diabetes is based on a combination of insulin resistance and beta~     cell dysfunction. In the last years, elevated FFA were recognized as a key players in the~     pathogenesis of insulin resistance and type 2 diabetes.~      The study compares the acute effects of an oral lipid bolus on insulin sensitivity and~     hepatic glucose metabolism in healthy humans.~   "
100920|NCT01736189|"~     In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab~     (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for~     effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other~     measures, as well as safety in terms of the incidence and pattern of occurrence of adverse~     drug reactions.~   "
100925|NCT01736124|"~     Computerized cognitive training (CCT) is an intervention has improved cognitive functioning~     in the elderly with and without cognitive impairment. The investigators will study the~     effect of a CCT program over an active control, classic computerized games. The outcomes~     will be memory and executive functions/attention, diabetes elf-management and adherence to~     medications, and glycemic and blood pressure control. Non-demented elderly Veterans with~     diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J.~     Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio~     of the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which~     the Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention~     and MyHeatheVet will collaborate in disseminating results to encourage implementation~     throughout the VA~   "
100926|NCT01736111|"~     Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled~     in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive~     usual medical care, printed materials, and educational text messages. The INTERVENTION group~     will also receive personalized coaching and feedback, as well as peer support, via text~     message.~      The investigators hypothesize that compared to those in the Control group, patients in the~     Intervention group will lose more weight and demonstrate more favorable changes in fruit and~     vegetable intake, exercise, and social support for weight loss.~   "
100927|NCT01736098|"~     The focus of this randomized clinical trial study is an examination of the effects of~     maintaining energy balance at different energy fluxes. It will address the primary question:~     Are there increased health benefits related to body composition and metabolic function~     associated with maintaining energy balance at a high energy flux as compared to a low energy~     flux?~   "
100928|NCT01736085|"~     The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling~     condition) randomized trial to test the provision of nicotine patches to help smokers~     calling a telephone quitline. The study assesses one factor related to nicotine patches with~     3 levels: sending patches directly from the Helpline, providing vouchers that can be~     redeemed for patches, and usual care. A second factor is counseling plus materials versus~     materials only. This proposed study has the following specific aims:~        1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for~          smokers who do not have access to free nicotine replacement therapy (NRT)~        2. To demonstrate that sending patches directly from a quitline would outperform sending~          vouchers for free NRT, since the vouchers impose an additional barrier to those who~          want to quit~        3. To determine the effect of telephone counseling in the context of nicotine patch~          distribution and if any interaction effects exist between counseling and patch~          conditions~   "
100929|NCT01736072|"~     The purpose of this study is to compare two different surgical procedures for the treatment~     of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR~     study is for participants with cancer of the rectum for whom a laparoscopic operation~     (sometimes called keyhole surgery) has been recommended by their surgeon.~      In the past most rectal cancers were removed using open surgery. Open surgery involves a~     large cut down the middle of the patient's abdomen to allow the surgeon to see and take out~     the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal~     cancers was as good as open surgery for curing cancer.~      There is now another option to remove rectal cancers, which involves using a robotic system~     with laparoscopic surgery. This type of surgery is called robotic-assisted laparoscopic~     surgery and is now becoming widely used by surgeons to remove cancers including the rectum,~     as well as for other non-cancer operations.~      In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic~     control unit a few feet away from the patient. Using the robotic control unit, the surgeon~     can see a clear video image of the patient's abdomen and the operation site. The surgeon can~     perform the operation from the robotic control unit by controlling the movement of a set of~     robotic surgical instruments, guided by the video camera.~      Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation~     through a few small cuts in the abdomen. The camera of the robotic system provides a 3D~     high-definition magnified view of the operation site and the robotic system is also able to~     translate the movements of the surgeon's hands into small precise movements inside the~     patient's body.~      We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at~     removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted~     laparoscopic surgery is used as standard of care in rectal cancer patients at University of~     California, Irvine Medical Center). We also want to investigate whether using~     robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation~     needs to be converted to an open operation, and see whether using a robotic system can also~     shorten the length of time patients need to stay in hospital and if it reduces the number of~     complications patients may have during and after their operation.~   "
100930|NCT01736059|"~     This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem~     cells from bone marrow into the eye as treatment for patients who are irreversibly blind~     from various retinal conditions.~   "
100931|NCT01736046|"~     The investigators will be assessing the efficacy of a Model Based Iterative Reconstruction~     algorithm (MBIR) as a noise reduction tool in computed tomographic (CT) examinations for~     Crohn's Disease. MBIR is computer adapted mathematical calculation technique that generates~     CT images with less picture degradation (noise) than traditional computer reconstruction~     techniques such as FBP (Filtered Back Projection) and ASIR (Adaptive Statistical Iterative~     Reconstruction), for enteric Crohn's Disease findings.~      The research involves collection of data from subjects standard of care diagnostic CT scan~     and from a research low radiation dose scan performed immediately following their diagnostic~     scan. We will determine the impact on image quality, interpretability, and Crohn's Disease~     findings of the low dose scan compared to the standard of care scan.~      FBP, MBIR, and ASIR are post processing tools that do not alter the scan acquisition itself.~   "
100932|NCT01736033|"~     The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy~     and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate~     hyperplasia patients, and suggest guidelines of the combination therapy.~   "
100933|NCT01736020|"~     This preclinical phase 1 development study in healthy volunteers seeks to identify if low~     doses of commonly used non-triggering anesthetic agents might have clinical utility for~     modulating emotional memory processing and to understand the nature of the brain mechanisms~     of drug action. Optimally, a drug, dose and brain mechanism of action will be identified~     that will form the foundation for future use in clinical studies of patients with PTSD.~   "
100934|NCT01736007|"~     Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting~     in hair loss of the scalp, and in severe cases of the entire body. AA is the second most~     common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused~     narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin~     diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser~     for treatment of patch type AA of the scalp will be examined. We anticipate the excimer~     laser will be safe and a feasible option for patients with patch type AA. The excimer laser~     may represent a novel treatment for childhood AA and no comparison or large studies~     currently exist in the literature.~      Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe~     treatment for patch type alopecia areata of the scalp in children.~   "
100935|NCT01735994|"~     Given the cost of treating eating disorders and the substantial morbidity and mortality~     associated with these disorders, prevention of eating disorders has considerable public~     health significance. Female athletes represent an important population for prevention due to~     their risk for the Female Athlete Triad, which includes inadequate energy intake, irregular~     or cessation of menses, and osteoporosis. The proposed randomized controlled trial will~     provide important information regarding the efficacy, acceptability, and feasibility of~     implementing a brief eating disorder prevention and healthy living program within an~     existing social system of female athletes.~   "
100936|NCT01735981|"~     To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise~     modality to improve gait and balance in individuals with Huntington's disease.~   "
100937|NCT01735968|"~     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase~     2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.~   "
100938|NCT01735955|"~     The purpose of this study is to allow continued use of nilotinib in patients who are on~     nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs~     (CD&MA) study and are benefiting from the treatment as judged by the investigator~   "
100939|NCT01735942|"~     The purpose of this study is to find out the effectiveness of ingenol mebutate compared to~     cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.~   "
100940|NCT01735929|"~     The purpose of this study is to find out the effectiveness of ultrasound treatment and~     liposuction combined on skin tightening around the neck.~   "
100941|NCT01735916|"~     This study is looking at whether the electrical treatment provided by a special type of~     pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's~     heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are~     electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body~     more efficiently.~      The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug~     Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump~     blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly~     less inefficient hearts will be observed to see if the electrical pacing treatment is better~     than not getting the treatment. This study is being conducted to support FDA approval of~     this type of pacemaker for people whose heart failure is less inefficient.~   "
100942|NCT01735903|"~     The purpose of this study is to measure the effect of nerve decompression on the recovery of~     the treated nerves. To obtain objective data during surgery of the treated nerves' via~     electrical signals and muscle power when stimulated. Also, to monitor muscle strength,~     balance/gait and blood flow in the lower extremity before and after surgery.~   "
100943|NCT01735890|"~     The objectives of this study are:~        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge~          10/160mg after a single oral administration in healthy male volunteers~        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis~          Exforge 10/160mg after a single oral administration in healthy male volunteers~   "
100944|NCT01735877|"~     Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the~     environment contra lateral to a cerebral lesion, can be a major source of functional~     handicap after stroke. The currently available treatments for unilateral neglect are~     scanning training, visual cuing approaches, limb activation strategies, visual imagery,~     tactile stimulation, prisms and sustained attention training.Mirror therapy improves the~     hand function in sub-acute stroke.~      Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke~     patients with unilateral neglect.~   "
100945|NCT01735864|"~     The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat~     psoriasis has been proven effective in our previous study. This study aims to evaluate the~     efficacy and safety of INEO ointment, and further determine the optimal concentration of~     INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of~     indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.~   "
100946|NCT01735851|"~     Pain following abdominal surgery is managed with the use of thoracic epidural analgesia~     (TEA) where the epidural is inserted in the spine at the level of scapula The risks due to~     TEA include difficulty with insertion, failure in up to 40% of patient in the perioperative~     period, fall in blood pressure and a rare devastating complication of paralysis either due~     to bleeding or infection. Injury to spinal cord is also a feared complication. Therefore~     alternative techniques need to be evaluated. Paravertebral block (PVB) has been documented~     to provide pain relief following abdominal surgery using an earlier technique which posed~     the risk of puncture of the covering to the lung (pleura) resulting in pneumothorax. The~     current technique involves the use of curled catheters inserted using ultrasonography to lie~     outside the pleura where the nerves travel thus reducing the chances of pneumothorax and~     catheter migration. Objective of the current study is to compare the efficacy and safety of~     bilateral PVB with TEA. Patients undergoing bowel surgery will be randomized to receive~     thoracic epidural analgesia or bilateral thoracic paravertebral blocks. Pain scores during~     rest and coughing, failure and complication rates will be compared between the two groups.~      Objective:~      The objective of the investigators is to determine whether ultrasound (US)-guided bilateral~     thoracic paravertebral blocks (PVB) using curled catheter provides effective post-operative~     analgesia as compared to thoracic epidural analgesia in patients undergoing open abdominal~     bowel surgeries.~      The primary outcome of this study will be the pain scores over the first 24 hours following~     open bowel surgeries.~      Secondary outcomes include~        1. Analgesic consumption in the perioperative period,~        2. Block related data (block performance time, success rate, extent of sensory block,~          complications)~        3. Hemodynamic parameter every 6 hourly~        4. Incidence of side effects like nausea and pruritus scores, time to return of bowel~          activity~      Hypothesis~      Null Hypothesis: Primary.~      Paravertebral blocks provide equal analgesia in the early postoperative period (first 24~     hours of surgery) as compared to thoracic epidural analgesia in patients undergoing bowel~     surgeries by laparotomy.~      Secondary~        1. The analgesic consumption between PVB and TEA is not different during the first 24~          hours following surgery~        2. The block performance time, success rate and extent of sensory block with PVB are not~          different from that of TEA.~        3. Side effects and complications following bilateral PVB are not different from those~          occurring after TEA~   "
100971|NCT01735526|"~     Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of~     absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently~     detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be~     hypothesized that these changes might be due to an occult intersitial lung disease~     associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative~     conditioning regimens or any combination of these. To test this hypothesis, we will~     simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO and~     estimate the changes of membrane diffusing capacity (DM) and pulmonary capillary volume (Vc)~     by the DLNO/DLCO ratio. As we hypothesize that GHVD should be intuitively absent amongst~     autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio~     showed by the latter group with those of subjects undergoing allo-HSCT.~   "
100972|NCT01735513|"~     Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve~     implantation by the use of an embolic protection device.~   "
100947|NCT01735838|"~     Summary Rationale: Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and~     implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected~     patients with systolic heart failure, ameliorating both morbidity and mortality. However,~     with current selection criteria and implant technique, about 20 to 30 % of patients remain~     non-responders. Non-responders might be due to failing selection criteria or methodology in~     casu echocardiography. Moreover, the definition of response to CRT is unequivocal and there~     is a need for a simple and reproducible measure of response with low inter- and~     intra-observer variability.~      Primary objectives: This study evaluates the correlation between intrathoracic blood volume~     (ITBV) measured by contrast enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI),~     as well as the feasibility to use intrathoracic blood volume as a predictor for response to~     CRT.~      Study design: a prospective nonrandomized pilot study Study population: patients with heart~     failure New York Heart Association (NYHA) class III or IV, a left ventricular ejection~     fraction equal to or less than 35% and a QRS-duration equal to or more than 0.12 seconds who~     are referred to our centre for implantation of a CRT-P or CRT-D device.~      Intervention: No specific intervention will be performed. Main study parameters: correlation~     between intrathoracic bloodvolume measured by CEUS and MRI, correlation between LVEF~     measured by CEUS and by standard 2D ultrasound (biplane methods of discs), change in~     intrathoracic blood volume as a response to CRT.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: at baseline a clinical examination, laboratory analysis, cardiopulmonary~     exercise testing, echocardiography and cardiac magnetic resonance imaging will be performed.~     All of these examinations will be repeated at 3-months follow-up except for the cardiac~     magnetic resonance imaging. All examinations, except for the MRI, are part of the standard~     workup in our hospital for patients undergoing implantation of a CRT device. Data needed for~     the purpose of this study, will be acquired by offline image analysis with dedicated~     software.~   "
100948|NCT01735825|"~     The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy~     using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug~     eluting stents releasing everolimus.~   "
100949|NCT01735812|"~     The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure~     medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a~     percutaneous lap-assisted approach.~   "
100950|NCT01735799|"~     Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which~     revolve around insulin resistance, it is tempting to examine the specific liver profile of~     women with PCOD. Furthermore, it would be of great importance if lean women who suffer from~     PCOD would be revealed to shere cardiovascular risks with their more overweight peers.~      Patients - women who will be diagnosed with PCOD following their initial referal to our~     fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due~     to either unexplained or male factor infertility.~      Workup - history for menstrual pattern; Clinical evaluation for features of~     hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase~     hormonal profile for validation of the diagnosis and for ruling out other pathologies which~     may cause anovulation.~      Liver profiling - The following blood tests will be used for the biochemical profiling:~     fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH,~     alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin~     ratio.~      FibroScan® will be used to measure liver stiffness.~   "
100951|NCT01735786|"~     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment~     techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common~     complication following EMR. Several endoscopic hemostasis methods are currently in use.~     EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was~     previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic~     application remains unknown. This study has been designed to observe the effect of~     rebleeding prevention after EMR.~   "
100952|NCT01735773|"~     The investigators aimed to study the effect of prohepcidin levels on hematologic parameters~     and inflammatory markers in non-diabetic uremic patients. The investigators selected three~     groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4~     chronic kidney disease. A control group was formed from healthy volunteers also. Each group~     has been planned to be formed of about 25 patients. Diabetic patients were excluded.~     Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine~     biochemical analysis including hematological ones.~   "
100953|NCT01735760|"~     Anesthesiologists get a course on localizing the cricothyroid membrane on a human using~     ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either~     palpation or ultrasonography, in a randomised fashion, is tested.~   "
100954|NCT01735747|"~     In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin,~     vincristine (TNV) as the replacement of high-dose methotrexate to combine with concurrent~     chemoradiotherapy. Our objective was to assess our treatment strategies' availability based~     on response rates, progression-free survival (PFS), median PFS, and toxicity.~   "
100955|NCT01735734|"~     The purpose of this observational study is to ascertain the effects of cutaneous air cooling~     on vessel diameter within Capillary Malformations (CM).~   "
100956|NCT01735721|"~     The aim of this study was the radiographic and clinical comparison of Algipore with~     decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique~     using piezoelectric instruments.~   "
100957|NCT01735708|"~     The purpose of this study is to determine whether participation in the study intervention,~     which involves collaboration between the study interventionist and the participant's primary~     care physician, will reduce symptoms of pain and depression in HIV+ patients.~   "
100958|NCT01735695|"~     The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic~     fluid samples will be tested for meconium with a new assay. The results will be correlated~     with other laboratory tests.~   "
100959|NCT01735682|"~     It is hypothesized that whole body vibration exercise group will have significantly more~     improvement in physical functioning and reduction in fall incidence among institutionalized~     elderly, compared with conventional exercise group and control group.~   "
100960|NCT01735669|"~     Objectives: The objective is to demonstrate the superiority of remifentanil versus nitrous~     oxide as adjuvant analgesic treatment to increase the chances of success of external~     cephalic version in the management of non-cephalic presentation in women with singleton~     pregnancy at term. Another objective is to compare their safety, tolerability and~     acceptability.~      Methodology: single-center clinical trial, randomized, open, parallel-group and sequential~     design, with active comparator. Pragmatic approach. Sequential design of O'Brien-Fleming~     with two interim analysis. Analysis by intention to treat. Comparison of the rate of~     successful version, referred to analgesic effect, safety, caesarean rates and acceptability~     rate of the procedure for pregnant women.~   "
100961|NCT01735656|"~     Percutaneous coronary intervention (PCI) for the treatment of coronary bifurcation lesion~     (BL) remains a challenging task. The DK-crush have been established as a safe and~     efficacious dual-stenting technique, which can effectively improve the success rate of final~     kissing balloon inflation (FKBI) and reduce long-term major adverse cardiac events (MACE).~     However, in the clinical real world, especially when the bifurcation angle was relatively~     small, the DK-crush still has several limitations, such as kissing unsatisfied (KUS),~     relatively complex wiring or rewiring technique, incomplete stent coverage in the distal~     side of the side-branch ostium and near the carina, severe stent deformation or evenly acute~     stent destruction. Our observational study showed that the DK-culotte was also a safe and~     feasible dual-stenting technique and was equal to DK-crush in terms of improving FKBI and~     MACE. Nonetheless, there remain no studies for head-to-head comparison of clinical outcomes~     between the two approaches. We, thereby, carry out a multicentre, non-inferior, randomized~     and controlled trial to compare DK-culotte stenting versus DK-crush stenting in the~     treatment of true BL.~   "
100962|NCT01735643|"~     Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes~     mellitus is increasing. Although in early phases the disease might be successfully treated~     by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic~     medication a highly motivational system with low inhibition threshold is needed. Therefore,~     the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12~     weeks is able to improve HbA1c and weight in patients with type 2 diabetes.~   "
100963|NCT01735630|"~     The primary purpose of this study is to determine whether ELND005 is effective in treating~     symptoms of agitation and aggression in patients with Alzheimer's disease~   "
100964|NCT01735617|"~     The purpose of this study is to gather safety and effectiveness information about a new~     formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called~     congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone~     cortisol, which is released in the body following a regular daily pattern. The objective of~     the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream~     once Chronocort® is taken and what affects it has on other hormones in the body. Since~     Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is~     hoped that patients with CAH will be treated more effectively to manage their disease.~   "
100965|NCT01735604|"~     RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may~     make the body build an immune response to kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is resistant or refractory to~     chemotherapy.~   "
100966|NCT01735591|"~     The aim of this study was to evaluate the impact of the administration of probiotics on~     outcomes of patients qualified for liver transplantation, both in the pre-transplant period~     and in the early postoperative period.~   "
100967|NCT01735578|"~     Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in~     the newborn intensive care unit and represents a significant cause of morbidity and~     mortality in infants born prematurely. Among possible risk factors, a strong association~     between elective RBC transfusions in premature infants with anemia and the subsequent~     development of NEC has been consistently observed (6-11). However, a significant (and~     increasing) number of VLBW infants with anemia are managed with erythropoiesis stimulating~     agents (such as Epo) and iron and do not receive RBC transfusions during their hospital~     stay. The present study proposes to study this particular group of VLBW infants that remain~     with low (<28 %) hematocrit while receiving full enteral feedings.~      The investigators hypothesize that significant anemia in VLBW infants will be associated~     with a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (<0.75) as measured by NIRS,~     and that nasogastric feedings (NGF) in those particular patients will lead to further~     decreased splanchnic oxygenation. The investigators further postulate that CSOR values will~     be significantly lower among VLBW that develop NEC as compared to infants that do not.~   "
100968|NCT01735565|"~     This is a prospective observational study to determine the point after bone marrow~     transplant in adults and children at which the neutrophils derived from the transplanted~     stem cells are competent to form functional neutrophil extracellular traps (NETs).~     Furthermore, given the importance of platelet function for NET formation, we also plan to~     examine platelet activation and function as well as the platelet transcriptome using the~     same clinical samples.~   "
100969|NCT01735552|"~     Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading~     cause of morbidity and mortality among premature infants. NEC is the most common~     life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit,~     affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently~     interest has intensified regarding the possible association between elective red blood~     cell (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On~     a physiological basis, a few explanations for transfusion-associated NEC have been proposed:~     1) the physiological impact of anemia that can initiate a cascade of events leading to~     ischemic-hypoxemic mucosal gut injury predisposing to NEC [10]; and 2) increased splanchnic~     blood flow following RBC transfusion leading to reperfusion injury of gut mucosa.~      Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for~     in the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated~     by current clinical guidelines for treatment of anemia, and prospectively assess for~     clinical signs and symptoms of NEC following each transfusion event.~      Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood~     samples will be assessed in vitro for neutrophil extracellular traps (NET) formation.~      Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated~     with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases~     splanchnic oxygenation. We postulate that the CSOR will be low (<0.75) at baseline~     measurement in infants with hemodynamically significant anemia, and that RBC transfusion~     will temporarily increase intestinal perfusion in that particular group of babies.~      B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can~     predict the development of NEC in VLBW infants. We hypothesize that overall~     cerebro-splanchnic oxygenation ratio (CSOR) values will be significantly lower among very~     low birth weight (VLBW) infants that develop NEC, when compared to CSOR values obtained in~     infants that do not develop NEC following RBC transfusion.~   "
100970|NCT01735539|"~     The investigators plan to measure changes in muscle protein metabolism in response to~     feeding, comparing between a single large essential amino acid (EAA) feed (the normal~     building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min~     intervals. The investigators will perform this study in healthy older (65-75y) and younger~     (18-28) men. The investigators will also explore how feeding affects muscle blood flow as~     this is important in the delivery of the nutrients we eat to the muscle where they are used.~      The investigators plan to supplement the feed with arginine, a safe and widely found~     non-essential amino acid, to explore if this can improve muscle blood flow.~   "
100973|NCT01735500|"~     A prospective Study, aiming to understand and analyse the key role of the novel High~     Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated~     coronary angiography without receiving any additional intervention. The peri-procedural~     elevation of the hsTnT indicates some other factors being responsible for the elevation of~     the hsTnT in absence of an acute coronary syndrome, such as physiological components or~     micro-injuries. A one year follow-up has been collected.~   "
100974|NCT01735487|"~     The aim of the present study is to compare cognitive scores (attention, executive function~     and working memory) of different e-Cigarette strength with usual cigarettes.~   "
100975|NCT01735474|"~     The main objective of this study is to evaluate the effectiveness of different manual~     techniques included traditionally on respiratory physical therapy~   "
100976|NCT01735461|"~     Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is~     common, particularly among Crohn's patients who had a small bowel resection. This patient~     population experiences a lifetime occurrence of kidney stone formation as high as 25%~     accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in~     the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an~     attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary~     oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium.~     This study's primary objective is to scientifically define an appropriate range of calcium~     supplementation that reduce the level of oxalate found in the urine of patients living with~     inflammatory bowel disease.~   "
100977|NCT01735448|"~     Aim: To identify barriers and facilitators in the uptake of smoking cessation~     pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held~     health priorities and barriers to research in Aboriginal Australians from the perspectives~     of:~        -  Aboriginal smokers and ex/non-smokers~        -  Aboriginal Healthcare workers~        -  Consultants/general practitioners, and~        -  Key stakeholders in Aboriginal health~      Focus groups, one-on-one interviews and surveys will be conducted to provide information at~     the 'grass-roots' level including examinations into perceived differences in locally held~     beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs,~     to assist implementation of future tobacco cessation/prevention interventions and treatment~     of smoking related illnesses. This information can be used to improve the health of~     Aboriginal people by identifying inadequacies in current practices and highlighting what~     these are through the eyes of community members, healthcare workers, consultants/general~     practitioners and key stakeholders. We also intend on examining any facilitators that are~     identified as positive and working aspects of current initiatives e.g. community~     infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.~   "
100978|NCT01735435|"~     The aim of this study to assess the impact of nutritional support guided by repeated~     measurements of REE in geriatric patients following surgery for hip fractures.~      Our hypothesis is that tight caloric control will reduce the risk of significant~     postoperative complications in geriatric patients following surgery for hip fractures.~      Study Design :Prospective, Single center, Randomized, Unblinded study. Study~     Population:geriatric patients following surgery for hip fractures.~   "
100979|NCT01735422|"~     This is a single center, open-label, randomized, parallel group, dose finding study to~     evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®),~     compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given~     subcutaneously, in inducing ovulation in infertile women undergoing stimulation of~     follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).~   "
100980|NCT01735409|"~     This is a single center, non-randomized phase IIa study to determine the tolerance and~     safety of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced~     nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been~     infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE~     V4.0 and RECIST 1.1 respectively.~   "
100981|NCT01735396|"~     This is a pilot study of abiraterone acetate in African American/Black patients with~     castration-resistant prostate cancer. The primary objective is to determine the correlation~     between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥~     30%) in African American patients with castration-resistant prostate cancer treated with~     abiraterone acetate. Patients will receive abiraterone acetate until the time of disease~     progression, in the absence of prohibitive toxicities. Patients will be followed for disease~     progression and survival.~   "
100982|NCT01735383|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy, adult human subjects.~   "
100983|NCT01735370|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy, adult human subjects.~   "
100984|NCT01735357|"~     The purpose of this study was to determine whether supplementation with oils enriched with~     long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial~     and vascular function.~   "
100985|NCT01735344|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, male and female human subjects.~   "
100986|NCT01735331|"~     The aim of this study is determine vascular endothelial growth factor levels and~     angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients~     who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels~     will be measured by immunohistochemical staining methods due to office hysteroscopic~     endometrial biopsy after the menstruation at follicular phase of menstrual cycle.~   "
100987|NCT01735318|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, male and female human subjects.~   "
100988|NCT01735305|"~     Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients~     with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy~     are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to~     demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD~     patients, and to explore predictors of ischemic or bleeding events in such cohort.Patients~     above 18 years old who were diagnosed as CAD and received antiplatelet therapy were~     prospectively enrolled in this national wide, non-intervention registry. All medications and~     laboratory tests were physician discretion.~   "
100989|NCT01735292|"~     The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to~     have their ventilator placed on a timer which at a specific time in the future stops the~     ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to~     be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration~     Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes~     during the use of the timer with the regular ventilator. In addition, we will evaluate~     whether the timer stops the ventilator and switches to CPAP at the designated time.~   "
100990|NCT01735279|"~     Nicotine dependence may prolong the exposure to toxic substances that cause various~     diseases. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated~     Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the~     modulation of dopaminergic neurotransmission. In its deficiency is detected a~     hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system,~     involved on the context of nicotine dependence. Treatment using dietary supplementation with~     omega-3 shows improvements in several diseases, including mood disorders such as anxiety and~     depression. The investigators hypothesis is that supplementation with these fatty acids can~     restore the levels of omega-3 and could decrease nicotine dependence. The investigators~     objective is to investigate a possible association between increased serum levels of omega-3~     and the reduction in nicotine dependence.~   "
100991|NCT01735266|"~     In most of situation, left colon (especially SD junction) is considered the most difficult~     part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and~     patients may feel pain or uncomfortable. It is suggested more than half of the whole time~     for scope insertion should be used in left colon. Many methods, such as water immersion,~     abdominal palpation, have been used to facilitate insertion in left colon.~      Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing~     medication used, pain experienced during colonoscopy, increasing the success rate of cecum~     intubation and adenoma detection rate in sedated and unsedated patients undergoing screening~     colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents~     lengthening and distension of the colon during colonoscopy. This will facilitate the~     colonoscopy in average or difficult colonoscopy. However, it is not known whether the~     benefits of water exchange method of colonoscopy was mainly due to its effect on the left~     colon.~      We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect~     regarding the maximal pain score and mean pain score in unsedated patients compared with~     whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion~     time compared with WWE. Here we performed a prospective, randomized controlled study to~     investigate the efficacies of whole-colon water exchange, left-colon water exchange and air~     methods of colonoscopy on pain score and insertion time in unsedated outpatients.~   "
100992|NCT01735253|"~     Surgical treatment for type 2 diabetes has been taken note especially in less obese or non~     obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater~     than that of the obese.~      We are trying to do a prospective observational study for the evaluation of the effect of~     duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.~      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with~     viceral obesity, insulin use less than 10 years and the patients understanding the~     hypothesis of this study, risks, expecting effects and agreeing this study.~      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some~     anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.~      We will compare the clinical factors at each time.~   "
100993|NCT01735240|"~     The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic~     profile when administered with ketoconazole. Subjects will be treated first with AZD5069~     only followed by a washout period before starting with the combined treatment (both~     ketoconazole and AZD5069).~   "
100994|NCT01735227|"~     In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect~     , the investigators designed a clinical randomized controlled trials of omeprazole and~     pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have~     taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly~     divided into omeprazole and pantoprazole groups . On the day of admission , all patients~     taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of~     clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,~     pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (~     before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days ,~     each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet~     aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical~     adverse events ( including death , myocardial infarction , and any revascularization , stent~     thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding~     events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1~     year follow-up results , and further explore the optimal combination of dual anti-platelet~     and joint PPIs course of treatment , appropriate dosage and the best time to provide~     reasonable for clinical programs to create a personalized treatment system , improve the~     patient's quality of life .~   "
100995|NCT01735214|"~     This study is a prospective, observational study of changing from any IOP-lowering treatment~     to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary~     Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications~     lies with the physician according to their standard practice.~   "
100996|NCT01735201|"~     This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice~     daily compared to vehicle for the treatment of moderate to severe facial erythema associated~     with rosacea.~   "
100997|NCT01735188|"~     Primary objective:~      Characterize the natural history of MoCD type A in terms of survival~      Secondary objectives:~        1. Evaluate blood and urine for biochemical markers~        2. Evaluate head circumference, seizure activity and neurologic outcomes~        3. To evaluate brain MRI~        4. Compare blood and urine analysis, head circumference, seizure activity and neurologic~          outcomes to MRI findings~   "
100998|NCT01735175|"~     The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to~     the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy~     in breast cancer patients.~   "
100999|NCT01735162|"~     Acute kidney injury (AKI) is a common clinical event with severe consequences. In the~     pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence~     suggests that children are dying not just with AKI, but from AKI. Unfortunately, the~     treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of~     kidney injury that change only when significant damage has already occurred has rendered~     potential therapies ineffective. For this reason, identification of new markers of AKI that~     change early in the course of injury is paramount. While new AKI biomarkers have been~     identified, their performance in the general PICU population is variable. The investigators~     recently proposed the concept of 'renal angina' as a way to risk stratify patients in the~     ICU for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina~     in PICU patients alone and in combination with urinary biomarkers for AKI prediction. The~     investigators hypothesize that renal angina will increase the predictive precision of~     urinary biomarkers for AKI.~   "
101000|NCT01735149|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.~     The investigators measured improvement of blood lipids parameters , including Total~     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.~   "
101001|NCT01735136|"~     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of~     Helicobacter pylori infection. The investigators measured improvement of Helicobacter pylori~     infection parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and~     monitored their blood pressure.~   "
101002|NCT01735123|"~     The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by~     which an extensively hydrolyzed casein formula is able to protect children at risk for type~     1 diabetes (T1D) from beta-cell autoimmunity.~   "
101003|NCT01735110|"~     The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus~     TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.~   "
101004|NCT01735097|"~     Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer~     arsenical keratosis~   "
101005|NCT01735084|"~     HYPOTHESES:~        1. That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls~          having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody~          levels, lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36~          months of age.~        2. That infants receiving PCV13 as a booster at 13 months of age, compared to controls~          having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes~          3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation~          at 18 and 36 months of age.~   "
101006|NCT01735071|"~     This study is aimed at assessing the efficacy and the safety of the combination of~     bevacizumab and trabectedin with or without carboplatin in adult women with epithelial~     ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or~     second) platinum-containing regimen. According to the Bryant and Day design the primary~     endpoints will be the proportion of progression-free patients at 6 months for the efficacy,~     and the proportion of patients with severe toxicity for the safety at the same time-point.~   "
101007|NCT01735058|"~     This study will be performed to examine the effect of ultrasound-guided subacromial sodium~     hyaluronate injection in patients with impingement syndrome without rotator cuff complete~     tear.~   "
101008|NCT01735045|"~     This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft~     contact lenses when used as a daily wear contact lens for the correction of myopia.~   "
101009|NCT01735032|"~     Epilepsy is the most common chronic neurological disorder in the world, affecting more than~     50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to~     all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal.~     Patients with drug-resistant focal epilepsy suffer from an increased risk of death,~     primarily due to seizure-related fatalities, in comparison with the general population. The~     only therapeutic option for this form of epilepsy is the surgical removal of the region of~     the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the~     precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients.~      Today the gold standard for localizing the EZ and validating a non-invasive technique for~     localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or~     SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral~     depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic~     Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose)~     and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the~     pre-surgical localization of the EZ has already been shown, no wide-scale study has examined~     the cumulative contribution of these three techniques.~   "
101010|NCT01735019|"~     In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough~     during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid~     leakage. Previous reports demonstrated that administration of remifentanil during anesthetic~     emergence could reduce the incidence and severity of cough during anesthetic emergence.~     Therefore, the objective of this study is to determine EC95 of remifentanil for preventing~     cough during anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal~     approach.~   "
101081|NCT01734096|"~     The purpose of this study is to determine whether in pre-hypertensive states such as white~     coat hypertension or obesity related hypertension, renal function is more sensitive to~     orthostatic stress.~   "
101011|NCT01735006|"~     This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine~     manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to~     demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18~     years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity~     and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference~     of safety and immunogenicity among different lots. Approximately 6000 study subjects will be~     enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV)~     vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a~     0-1-6 month schedule.~   "
101012|NCT01734993|"~     This multicenter, open-label, single arm, interventional, long-term extension (LTE) study~     will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French~     participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE~     study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed~     the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having~     improvement in disease activity score based on 28-joint count [DAS28] of greater than [>]~     1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156~     weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available,~     whichever occurs first.~   "
101013|NCT01734980|"~     Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial~     ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples~     when no suction is applied.~   "
101014|NCT01734967|"~     Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of~     patients being alive at five years. EUS (endoscopic ultra sound) is an established,~     sensitive diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS~     enables guided fine needle aspiration (FNA), which is currently recommended as the~     first-line procedure whenever a pathological diagnosis is required. However, EUS-FNA as a~     sampling method has its drawbacks, due to a relatively low negative predictive value.~     Confocal laser endomicroscopy has emerged in recent years as a novel method that enables in~     vivo microscopic analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy~     has gone beyond the superficial luminal indications with the development of a new~     microprobe, i.e. a flexible laser probe (nCLE) that can pass through a 19-gauge needle.~     Combined with EUS, descriptive criteria for the diagnosis of pancreatic cystic neoplasm has~     been developed in a multicentre trial. However, only a limited number of cases of solid~     pancreatic masses have been described with nCLE.~      Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or~     liver metastases identified during EUS procedures performed for pancreatic cancer staging~     (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The~     hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions~     resulting in more accurate diagnosis. XX patients were included all presenting with a~     clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During~     the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS~     guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data~     was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for~     cytology smears to enable a final pathological diagnosis. Correlations between the nCLE~     images and the conventional pathology were identified.~   "
101015|NCT01734954|"~     The purpose of this study is to evaluate the latency period (timing between the injection of~     the local anesthetic and the onset of complete sensory nerve block) of two approaches for~     ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of~     the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is~     injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned~     nerve. Our main hypothesis is that the first approach will decrease the latency period, and~     probably, will increase the success rate of the nerve block as well as patient satisfaction.~   "
101016|NCT01734941|"~     The primary objective of this study is to evaluate and compare the safety and efficacy of~     Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.~      Evaluation of the safety and tolerability of treatment with TSO in the target population~     across the dose range being tested is considered a primary objective, while the primary~     efficacy objective will be assessed via the change from baseline in the Aberrant Behavior~     Checklist (ABC) subscale scores.~      Dose response will be considered a primary objective as well.~      Secondary assessments of efficacy will be assessed via:~      • The change from baseline in the Clinical Global Impression scale (CGI-I)~   "
101017|NCT01734928|"~     The purpose of this study is to compare the efficacy of the combination of Pomalidomide,~     Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients~     with relapsed/refractory multiple myeloma. This study will also assess how safe the~     combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of~     Bortezomib and Dexamethasone~   "
101018|NCT01734915|"~     The purpose of this research study is to determine if the EGFR mutation can be detected in~     CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the~     bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of~     patients with cancer. This is an experimental device. Using this device, the investigators~     will test participants' blood to try and find CTCs with the EGFR mutation and compare them~     with the results from the biopsy your doctor has recommended. The long-term goal of this~     research is to develop a way to test for the EGFR mutation that is less invasive than a~     tumor biopsy.~   "
101019|NCT01734902|"~     The objective of the current trial is to establish the bioequivalence of 2 hyoscine~     butylbromide dose forms following oral administration.~   "
101020|NCT01734889|"~     The purpose of this study is to verify that pediatric patients, especially those who are not~     old enough to swallow capsules, accept the taste and palatability of a new suspension.~   "
101021|NCT01734876|"~     The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality~     of Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and~     chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or~     only Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10~     weeks was the intervention period , followed by a follow-up period. Outcome measures were~     salivary cortisol concentration measured at seven occasions of which two were immediately~     before, after and 30 minutes after intervention. Diurnal salivary cortisol was calculated~     based on four timepoints of sampling per 24 hour period.~   "
101082|NCT01734083|"~     The whole body vibration exercise group will have significantly more improvement in~     mobility, muscle strength, balance, balance confidence, and cognitive function with a lower~     fall rate than the control group.~   "
101919|NCT01723046|"~     The purpose of this pilot study is to investigate the clinical effects of a new upper limb~     robot assisted therapy device that is linked to a virtual therapy environment in patients~     with stroke.~   "
101022|NCT01734863|"~     Local recurrence after surgical resection is a complex phenomenon. An important predictive~     factor is the response to chemotherapy. Central site of disease may be a second independent~     predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at~     surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free~     Survival [EFS] of 47% after 10 years. Patients with good histological response (< 10% viable~     tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.~      However, further studies are necessary to determine the merit of adjuvant radiation for~     high-risk patients (poor responders). Taking into consideration that the toxicity and~     morbidity of combined surgery and radiation is greater than either alone and must be closely~     monitored.~   "
101023|NCT01734850|"~     This is an early phase research study looking at whether an experimental gene transfer,~     LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the~     effects of HIV without the use of antiretroviral drugs.~      Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2~     active parts:~        1. Removing a protein named CCR5 from bone marrow and white blood cells~        2. Producing a protein named C46 on bone marrow and white blood cells~   "
101024|NCT01734837|"~     Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute~     appendicitis. Although the surgical technique of laparoscopic appendectomy has been well~     established, some controversy exists regarding the closure of the appendiceal stump. The~     available methods for stump closure are currently: pre-knotted loops (Roeder Loops or~     Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation~     Clip. The design of the DS-Clip is characterized by two parallel shanks.~      The aim of this study is to collect data of a large number of patients treated with the~     product in real-life clinical routine.~   "
101025|NCT01734824|"~     The etiology of bone marrow edema (BME) is still uncertain. Several studies report~     therapeutic success with antiresorptive drugs.~      This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME~   "
101026|NCT01734811|"~     The purpose of the study is to evaluate the efficacy of a biological vaccine to prevent~     episodes of bronchospasm, induced by recurrent respiratory tract infections, in children,~     compared with a placebo group.~   "
101027|NCT01734798|"~     Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local~     recurrence is still the major cause of failure together with distant metastasis.~     postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the~     overall survival. Adjuvant chemotherapy has also improved the survival in different studies.~     This study is performed to test the efficacy and toxicity of adding the two modalities~     together compared to each modality alone.~   "
101028|NCT01734785|"~     This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM~     patients on 16 wks linagliptin treatment and metformin background therapy.~   "
101029|NCT01734772|"~     To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and~     ticagrelor under steady state conditions; to investigate the effect of staggered~     administration of ticagrelor loading dose on dabigatran exposure (in Part II)~   "
101030|NCT01734759|"~     The purpose of this study is to see if a medication taste test influences the prescribing~     habits of pediatric prescribers at Mayo Clinic.~   "
101031|NCT01734746|"~     As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of~     sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph~     node or sentinel node. If the sentinel node does not contain cancer, there is a high~     likelihood that the cancer has not spread to other lymph nodes. This means that, at least~     theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity.~     The sentinel node technique has been proven to be effective in different cancers such as~     breast cancer and malignant melanoma. In gynaecological tumors it has been shown to be~     effective in vulvar cancer. Currently sentinel node studies are done for cervix and uterine~     cancer.~      The present study determines whether or not a sentinel node procedure in patients with~     ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.~   "
101032|NCT01734733|"~     To assess the safety of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed~     over the duration of the study, by monitoring the occurrence of adverse events and serious~     adverse events, including clinical and laboratory evidence of xenogeneic infection in~     transplant recipients and their partners/close contacts. Subsequent safety follow-up will~     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.~      To assess the clinical effects of NTCELL [immunoprotected (alginate-encapsulated) choroid~     plexus cells] in patients with Parkinson's disease. This will be quantified by testing the~     secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).~   "
101033|NCT01734720|"~     The aims of this study were to~        1. investigate what measures were taken when common bile duct stones (CBDS) were found~          intraoperatively in Sweden during the period May 2005 to December 2009 by using data~          from this population-based nationwide registry, and~        2. analyze the outcome in terms of complications and success rates of bile duct clearance~          in relation to various stone sizes and interventions used. In order to further~          characterize the natural course of CBDS of various sizes, particular interest was~          focused on patients with positive findings where no peroperative measures to clear the~          bile ducts were taken or planned postoperatively.~   "
101034|NCT01734707|"~     This study was designed to estimate the effect of two-year treatment with time-released~     garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded~     placebo-controlled randomized clinical trial.~   "
101035|NCT01734694|"~     For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of~     vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have~     waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a~     clinical concern. This may be due to various reasons, including new dosing recommendations~     as well as an increased prevalence of risk factors associated with vancomycin induced~     nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney~     damage from vancomycin use.~   "
101943|NCT01722734|"~     A randomized controlled trial was conducted to assess the effectiveness of text reminders~     sent to ACT users through an automated text messaging system short-message-system.~      Study hypothesis: text message reminders increase adherence~   "
101036|NCT01734681|"~     Prostate cancer that has returned after local treatment usually responds to hormone blocking~     treatment, but most patients eventually experience disease progression. Further chemotherapy~     does not normally lead to a cure or dramatic improvement in the disease and there is a need~     to identify new drugs that are beneficial for these patients without unacceptable side~     effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is~     administered to the patient and gets activated within the body at specific locations,~     resulting in a higher concentration of the cytotoxic form at a tumour location whilst~     avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have~     many general side effects because it is converted to a cell toxin only at the tumour or~     other specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen~     (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most~     solid tumours, but not by normal cells or blood vessels in normal tissue. It is believed~     that activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly~     prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with~     castration-resistant prostate cancer (CRPC), which means the cancer has progressed after~     hormone blocking treatment, but who have not yet received chemotherapy and who have no or~     only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of~     G-202 administered on three consecutive days of a 28-day cycle.~   "
101037|NCT01734668|"~     The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA~     with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of~     age.~   "
101038|NCT01734655|"~     The Specific Aim of this supplemental project is to evaluate the Mindful Eating~     Questionnaire (MEQ) to determine if it is a valid instrument for pregnant women. During this~     project, the MEQ will be qualitatively evaluated in a sample of pregnant women who are~     similar in age, ethnicity, education, and marital status to the women targeted for~     recruitment in the parent study. The qualitative evaluation will include a focus group with~     10 participants followed by 30 individual cognitive interviews. Comments from the interviews~     will be summarized and analyzed systematically for each of the 28 questions of the MEQ and~     the interviewer will use findings from initial interviews to inform subsequent interviews.~     Content validity will be evaluated based on responses from the focus group and cognitive~     interviews, and MEQ items will be evaluated for comprehension, retrieval, judgment, and~     response. Strengths, weaknesses, relevance, comprehensiveness, and interpretations will be~     reported for each of the MEQ questions. We will also have some of the more traditional~     validation parameters (the inclusion of other questionnaires) in the study to collect data~     on convergent and discriminant validity. The resulting publication will provide readers with~     a thorough report on the utility and appropriateness of using the MEQ to quantify mindful~     eating in pregnant women.~   "
101039|NCT01734642|"~     A medication error is a failure in the treatment process that leads to, or has the potential~     to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in~     hospital. They can occur in different phases of the therapeutic process (prescribing,~     distribution, administration and monitoring) and have significant impact on morbidity and~     mortality. Prescribing faults and prescription errors are major problem among medication~     errors .Prescription errors account for 70 % of medication errors that could potentially~     result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7~     % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm~     arises from a medication error it is potentially preventable. The medication errors project~     was devised to analyze and limit through educational audit and other tools, as much as~     possible, damages due to the therapeutic process. The project will include 5 phases.~     Preliminary phase: organizational meetings. Phase I: Patient monitoring: a monitor in~     collaboration with health professionals of involved units will review all patient charts and~     will register all adverse drug reactions(ADRs). All ADRs will be introduced by the monitor~     in a database. Health professional will be invited to send the reports of observed ADRs.~     Evaluation of ADRs : a panel of experts will evaluate if the ADRs are due to medication~     errors or not. Phase II :educational audits directed to health professionals will be~     organized. Tools to reduce the medication errors will be proposed. Phase III: the same~     procedure of the first phase. Final phase (IV): analysis of data with publication of a~     scientific article.~   "
101040|NCT01734629|"~     Several studies show an association between chronic obstructive pulmonary disease (COPD) and~     coronary artery disease (CAD). Besides risk factors such as smoking, both are associated~     with physical inactivity, advanced age and systemic inflammation The use of coronary~     computed tomography (CCT) with multiple detectors is a diagnostic method for coronary~     disease, describing the anatomy and severity of arterial obstruction. One way of estimating~     the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD~     and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung~     function.~      The aim of this observational study is to establish the correlation between the CCS and lung~     function. It will also correlate the presence of irreversible airway obstruction with~     significant coronary lesions.~      Patients over 40 years referred to CCT who agree to participate in the study will perform a~     spirometry with bronchodilator and collect a blood sample to measure serum markers of~     inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP),~     tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the~     general population and in subgroups: smokers, former smokers and nonsmokers.~      One year after the CCT patients will be contacted by the investigators and accessed for~     emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory~     events.~      The investigators hypothesis is that reduced lung function is independently associated with~     elevated CCS and is, also a risk factor for increased hospital admission and coronary~     events.~      The concomitant assessment of lung function and CCS can contribute knowledge about the~     epidemiological association between pulmonary disease and CAD. This can also add to evidence~     for the use of spirometry as a marker of cardiovascular risk.~   "
101083|NCT01734070|"~     The goal of this study is to examine if chronic cherry consumption will decrease lipid~     peroxidation and serum concentration of inflammatory markers in human subjects with elevated~     serum C reactive protein (CRP), and to examine the relationship between serum concentrations~     of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce~     serum concentration of inflammatory markers, including CRP, inflammatory cytokines and~     adhesion molecules.~   "
101084|NCT01734057|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Rituximab for the treatment of adults with primary immune~     thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.~   "
102120|NCT01720420|"~     AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium~     with Locator attachment and related Overdenture on 4 NobelReplace implants with conical~     connection (CC) in the mandible/maxilla.~   "
101041|NCT01734616|"~     With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70%~     of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require~     strength, keep the body balanced and continue activity for a prolonged period, which~     together may contribute to a loss of independence and an increased risk of falls. The cause~     of some of this muscle loss with ageing appears to be a reduction in muscle building in~     response to food. The known decreased limb blood flow in ageing muscle may go some way to~     explain this as there may be less nutrient delivery to the muscles. The investigators want~     to test if the known decrease in limb blood flow with age is matched with a decrease in the~     proportion of blood being delivered directly to the muscles, rather than fat and connective~     tissue. If so the investigators expect to see an improvement in the ability of muscles to~     maintain themselves via better capture of amino acids into protein. The investigators also~     want to test if 20 weeks resistance exercise training or drinking a cocktail of mixture of~     high flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood~     flow to older muscles and help reduce muscle wasting.~   "
101042|NCT01734603|"~     Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with~     claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to~     patients with PAD have recently been proved effective and defined in many guidelines.~     Supervised walking training on treadmill is recommended. Usually patients walk up to a mild~     or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then~     stop until pain completely subsides and walk again .~      The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by~     alternating short sequences of intensive training and active recovery (without rest).~   "
101043|NCT01734590|"~     Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.~      The main objective is to identify one or two flour compositions in a carbohydrate-based food~     that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative~     absorption of exogenous glucose compared to the control.~   "
101044|NCT01734577|"~     Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of~     musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine~     for a neurophysiological effect.~   "
101045|NCT01734564|"~     In this phase II study, patients with solid tumors will receive treatment with hiltonol and~     autologous dendritic cells.~   "
101046|NCT01734551|"~     The purpose of this study is to compare two different medicines to treat babies with opiate~     withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a~     non-opiate. Morphine is a narcotic medicine, with is included in most pain killers.~     Clonidine is another drug, but is different from morphine. It is also used for babies, and~     even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study~     is to see if one may be better than the other.~   "
101047|NCT01734538|"~     The biological membranes that surround a cell and its organelles are important to the~     overall function of the cell. Fatty acids are the main structural components of a membrane,~     and the presence of certain fatty acids can alter a membrane's characteristics, which~     subsequently alters its function. Two fatty acids that are of particular interest to~     researchers are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3~     fatty acids have unique unsaturated structures, and their incorporation into biological~     membranes appears to elicit potent physiological effects. The body is unable to~     intrinsically synthesize these important fatty acids, so they must be obtained from the diet~     or through supplementation.~      EPA and DHA supplementation has been reported to provide numerous positive health benefits,~     including decreased blood pressure and an improved blood lipid profile. Recent research in~     our laboratory has demonstrated in young men that resting metabolic rate was increased~     following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization~     was also increased and carbohydrate use was decreased both at rest and during a 1 hr~     moderate exercise challenge. These findings have positive implications for people who are~     interested in losing weight, but it not known whether these effects occur in older adults.~     With age, body composition changes (increase in fat mass and decrease in lean mass) occur~     which may negatively affect general health, particularly normal physical functioning and~     quality of living of the older adult. The potential role of omega 3 fatty acids to increase~     fat oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass~     in the older adult. Research has suggested that omega 3 fatty acids may elicit an additional~     therapeutic role by reducing joint pain.~      Another aspect of aging is a loss in lean body mass, which is associated with an attenuation~     of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and~     insulin). The weakened anabolic response is considered to be partly due to defects in the~     anabolic signaling cascade in the muscle. Research in older adults has reported an increase~     in muscle protein signaling with EPA and DHA supplementation in response to a nutritional~     challenge. However it is unknown whether the increase in protein signaling results in an~     eventual increase in lean body mass. The physical functioning of older adults is not only~     influenced by body composition changes, but also age-related neuronal changes that affect~     the velocity of axonal conduction and influence the ability of the muscle to generate torque~     and the rate at which the torque is developed. Muscular strength and functional capacity~     increases have been reported with chronic resistance exercise in a cohort of older women~     supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical~     strength in older adults with previously low EPA and DHA consumption, independent of~     exercise, is currently unknown.~      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3~     supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling~     older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease~     in resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in~     resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and~     during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength~     and physical function.~   "
101048|NCT01734525|"~     This is a prospective study aimed at testing a strategy of early initiation of an antifungal~     agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis.~     Score system have been developed to identify groups at very high risk for the development of~     candidemia/invasive candidiasis in the ICU. These scoring system have used clinical~     information with or without data on Candida colonization, and have shown reasonable~     correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of~     1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The~     incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at~     higher risk for candidemia, and despite the fact that these tests may give false-positive~     results, their negative predictive value could be of great help. Likewise, analyzing the~     kinetics of these biomarkers in patients with candidemia/invasive candidiasis would help to~     define their usefulness in monitoring treatment.~      Therefore, the objectives of this study are:~        1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop~          invasive candidiasis/candidemia;~        2. To evaluate the kinetics of positive biomarkers after initiation of antifungal therapy~          in patients with candidemia;~        3. To test the strategy of early discontinuation of antifungal therapy based on repeatedly~          negative blood cultures and 1,3 beta-D-glucan in the serum.~   "
101049|NCT01734512|"~     This is an open label study of everolimus in children with recurrent or progressive~     low-grade glioma.~   "
101050|NCT01734499|"~     This study is proposed to assess long-term Quality of Life issues in breast cancer survivors~     by measuring the impact on the quality of life made by the structured Change Cycle Work~     Shop coping class as compared to current local standard of care programs. It has been shown~     that breast cancer treatment can have long-term bio-psychosocial consequences. Specific~     evidence-based interventions are needed to address Quality of Life concerns in order to~     improve the overall outcome of breast cancer and its treatment beyond the focus on mortality~     rate.~   "
101051|NCT01734486|"~     This trial is conducted in Europe. The aim of the trial is to evaluate growth response of~     two somatropin dose regimens in girls with Turner Syndrome.~   "
101052|NCT01734473|"~     Weight loss commonly occurs in patients with COPD, negatively influencing their quality of~     life, treatment response and survival. Loss of muscle protein is generally a central~     component of this weight loss and independently increases mortality. This study will provide~     relevant clinical information in regards to the anabolic properties of specific dietary~     substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a~     hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic~     than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and~     healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal~     only enhances the protein anabolic response in COPD patients and healthy older adults when~     carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient~     protein anabolic response to a hydrolyzed casein-based protein meal than healthy older~     adults.~      A fifth study day was added to measure protein requirements of included individuals to be~     able to interpret their response to the other interventions on the other study days, and to~     test the hypothesis that subjects with lower protein requirements respond less to~     intervention with leucine and/or carbohydrates. For the 5th additional test day we will~     first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study~     days (and signed the re-contact form) to come back for this extra test day. We will~     (pre-)screen these subjects by phone for eligibility and check for changes in their recent~     medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion~     criteria are still met, these subjects will be asked to provide a written re-consent. If~     necessary, we will recruit new subjects who will complete only one of the four test days~     (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is~     provided) and the additional 5th study day.~   "
101085|NCT01734044|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune~     thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.~   "
101053|NCT01734460|"~     Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with~     serious neurocognitive, metabolic and cardiovascular consequences that has a significant~     impact on public health. Evidence indicates that the physiologic changes occurring during~     pregnancy, particularly during the third trimester, increase the risk of those women to~     develop SDB. As in the general population, SDB during pregnancy is more frequent among obese~     women. In the light of the increasing prevalence of obesity among females of reproductive~     age, SDB may thus have an increasingly significant impact on women's and children's health~     by contributing to the adverse maternal and fetal outcomes associated with maternal obesity.~      Only a limited amount of data is available on the consequences of maternal SDB during~     pregnancy. Even less information is available on the effect of maternal SDB on fetal growth~     and development. The current proposal is designed to specifically explore the effect of~     maternal SDB on fetal growth.~      It has been suggested that fetal growth as reflected in birth weight is a strong correlate~     for conditions occurring in the intrauterine environment with potential long lasting~     influence on a child's health.~      Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the~     metabolic alterations associated with maternal SDB will affect fetal growth.~      Using a variety of methods and a multidisciplinary approach, we will explore the following~     objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that~     may underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3~     years of life) effect of maternal SDB on a child's growth.~      The results of this study will make an important contribution to the fields of women and~     children's health. It will provide better insight into the mechanisms by which disrupted~     maternal sleep affects fetal growth.~      We expect that the findings from our study will enable the defining of a new treatable~     clinical entity or syndrome: the infant of the gestational SDB mother, for which early~     diagnosis and intervention might be of major importance to the newborn infant.~   "
101054|NCT01734447|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety of~     long-term growth hormone treatment in growth-retarded children with intrauterine growth~     retardation (IUGR) enrolled in trial GHRETARD/F/1/F.~   "
101055|NCT01734434|"~     This study will collect information regarding the factors that might influence access of~     pregnant women to the local healthcare system. The main visits of the study will be~     screening & enrollment, delivery and 90 day infant follow-up. Data will be collected mainly~     from questionnaires administered to pregnant women at these visits. The questionnaires~     contain the following standard questions which will be asked at each visit, in addition to~     some visit-specific questions related to delivery and health status of infants up to 90 days~     of age. The standard questions will be related to the following aspects:~        -  Logistics of transportation to the study site (type, time it takes, cost incurred)~        -  Accessibility to a telephone/cell phone~        -  Provisions of alternative child care during site visits if there are other children~          under the subject's care~   "
101056|NCT01734421|"~     AIM: To assess the efficacy of an intervention based on the specific design and~     implementation of a mobile application (APP) in order to reduce the prevalence of smoking~     consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical~     trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat~     analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18~     to 30 years consulting for any reason to PHCC and who provided written informed consent to~     participate in the trial.~      INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline~     smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME~     MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of~     less or iqual 10 parts per million in each control.~      RESULTS: The application of a smoking cessation intervention with a mobile APPs application~     will improve the smoking cessation success rate in smokers, besides of their intention or~     not to give up smoking at baseline.~   "
101057|NCT01734408|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children~     caused by viruses that belong to the enterovirus genus of the picornavirus family. Although~     most HFMD cases do not result in serious complications, outbreaks of HFMD caused by~     enterovirus 71 (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused~     by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The phase II study of inactivated vaccine (vero cell) against EV71 has completed last month~     in Jiangsu Province in China. The data from the phase II study suggested that the~     inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for~     healthy Chinese children and infants. But the antibody titer against EV71 was found~     decreased significantly at month 8 compared to that at day 56. Considering the similar~     dynamic trend had also been found in the antibody against poliovirus induced by polio~     vaccines, and whose immunization schedule contains a booster dose administrated at 1 to 1.5~     year after the first 3 doses of fundamental immunity. In order to find a better immunization~     schedule for children, the investigators decided to perform this booster immunity trial~     among these children who had received two doses of EV71 vaccines (around one year after the~     fundamental immunity). The investigators do the recruitment among these children who had~     participated in the previous phase II trial and received EV71 vaccines, and randomize them~     in a ratio of 2:1 to receive either a booster dose of EV71 vaccines or placebo.~   "
101058|NCT01734395|"~     The purpose of this study is to demonstrate that the change of attention measure is~     correlated with the changes of caregiver's burden after treatment with galantamine.~   "
101059|NCT01734382|"~     PART1 Participants in Part 1 (Run-in-Phase) of study will receive Tocilizumab (TCZ)~     (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2~     weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during~     part 1 may be eligible to move into Part 2 of the study.~      PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics,~     pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose~     frequency in participants with adequately controlled systemic juvenile idiopathic arthritis~     who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing, that~     has since resolved. Participants will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg~     intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an~     event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4~     weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.~   "
101086|NCT01734018|"~     This multicenter, prospective, observational study will evaluate the efficacy and safety of~     Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive~     or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys~     according to standard of care and the summary od product characteristics/local labelling~     will be followed for the duration of treatment and up to 2 years of follow-up.~   "
102137|NCT01720199|"~     This is a field study aiming to evaluate a school-based prevention intervention, Diario~     della Salute (DDS).~   "
101060|NCT01734369|"~     Background:~        -  Myositis is a rare disease in which the body s immune cells attack the muscle tissue.~          It can cause muscle weakness, swelling, and pain. It can develop in people with no~          history of muscle problems. Environmental exposures may determine who develops~          myositis. Genes may also affect development of the disease.~        -  Some people who serve in the military develop myositis. However, other military~          personnel do not. Researchers want to compare military personnel with and without~          myositis. They will look for common factors that might have led to the disease.~      Objectives:~      - To study environmental risk factors for myositis in military personnel.~      Eligibility:~        -  Military personnel who developed myositis during their period of service.~        -  Healthy military personnel who do not have myositis or another autoimmune disease.~      Design:~        -  Participants will have a physical exam and medical history.~        -  Participants will fill out forms about environmental exposures, particularly while in~          the military. The questions will ask about past infections, vaccines and medications,~          and personal habits. They will also ask about participants occupations during military~          service and their deployments.~        -  Participants will also provide blood samples for study.~        -  No treatment will be provided as part of this study.~   "
101061|NCT01734356|"~     The recent developments of research on iPS (induced pluripotent stem) cells lead to the~     establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells~     with genetic and cellular characteristics of the donors. These cells represent a biological~     material more readily available to identify the pathophysiological mechanisms involved in~     the diseases of BrS or ERS patients, which will lead to the identification of genetic~     markers.~   "
101062|NCT01734343|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure~     that uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in~     today's small incision phacoemulsification surgery. Nowadays a multitude of microincision~     IOLs are available, many of them similar but of course with some differences in regard to~     the chemical composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 3 years.~   "
101063|NCT01734330|"~     Background: Pharmacological strategies to improve smoking cessation have been largely~     studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in~     tobacco cessation has not yet been demonstrated.~      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine~     replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52~     weeks.~      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334~     patients. Analysis will follow intention-to-treat principle.~      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year~     before randomization will be included.~      All of them will receive nicotine replacement therapy with patches and gum. They will be~     randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first~     six weeks of the treatment. Every two weeks all of the patients will be evaluated by a~     physician in order to access any adverse effects from the nicotine replacement.~      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.~     Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco~     cessation, relapses episodes and abstinence maintenance.~   "
101064|NCT01734317|"~     Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or~     the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or~     superficial deep-partial-thickness. The subject will be assessed once a week for a maximum~     of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex~     Transfer Ag will be used as wound contact layer and gauze rolls and compression as second~     dressing.~   "
101065|NCT01734304|"~     The aim of this study is to determine the feasibility and safety of an autologous DC~     immunotherapy in patients with AML of non-favorable risk profile.~   "
101066|NCT01734291|"~     The purpose of this study is to examine the effectiveness of brief multifamily~     psychoeducation to relieve the psychological distress of families of patients with chronic~     major depression and to improve their family functioning.~   "
101067|NCT01734278|"~     The purpose of this observational study is to evaluate the use and short term safety of~     Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United~     Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by~     the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the~     manufacturer of Sycrest.~   "
101068|NCT01734265|"~     The primary objective of this study is to evaluate the safety and tolerance of a rush build~     up administration of Depigoid forte pollen and the first maintenance dose administered 4~     weeks later.~   "
101087|NCT01734005|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The~     investigators measured decrement of body fat parameters , including Body Fat Mass, Percent~     Body Fat, weight and BMI(body mass index), and monitored their blood pressure.~   "
101088|NCT01733992|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     R348 eye drops in patients with dry eye disease.~   "
101089|NCT01733979|"~     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia.~     The investigators measured Improvement of Anemia parameters , including hemoglobin,~     transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.~   "
101069|NCT01734252|"~     Critically ill patients with high risk for thrombosis or tromboembolic events with the~     presence of heparin resistance, treated at the Department for General and Surgical Critical~     Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study~     when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion~     criteria and is recruited for the study, the patient will be randomized either to Group A or~     Group H.~      All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60~     sec (Pathromtin® SL) within 6 to 8 hours.~      Randomisation Group A:~      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,~     he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be~     given and adjusted until the target aPTT-range is achieved.~      Randomisation Group H - Standard therapy:~      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,~     he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary~     increased. Hereby the maximum heparin dose is 1.500 IU per hour.~      Therapy failure Group H:~      Primary target failure at Visit 3 (6-8 hours):~      If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will~     switch to Group A and will start with T1 (Baseline) and will follow the visits according to~     Group A until the final Visit 9 (T1 / day 30).~      Maintenance failure after Visit 3:~      Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until~     day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to~     be changed to Argatroban.~      The patient will start with T1 (Baseline) and will follow the visits according to Group A~     until the final Visit 9 (day 30) counting from the Baseline of Group A.~      Therapy failure Group A:~      If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain~     the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further~     study period, the patient automatically drops out of the study.~      The same is effective for patients who switched to the Group A after a therapy failure in~     Group H.~      General:~      Two hours after starting the Baseline investigations, patient's parameters in-cluding blood~     collections will be measured for the second time (T2). Additional measurements will be made~     at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and~     on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30~     days after inclusion in the study, a final investigation is planned (T9).~   "
101070|NCT01734239|"~     The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in~     participants from the Russian population who are 50 years of age and older or 2 to 49 years~     of age and at increased risk for pneumococcal disease~   "
101071|NCT01734226|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of~     Constipation. The investigators measured Improvement of Constipation parameters , including~     Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool~     amounts per defecation, and monitored their blood pressure.~   "
101072|NCT01734213|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on~     improvement of Cognitive Function. The investigators measured improvement of Cognitive~     Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and~     BCRS, and monitored their blood pressure.~   "
101073|NCT01734200|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on~     improvement of Memory Function. The investigators measured decrement of improvement of~     Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their~     blood pressure.~   "
101074|NCT01734187|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of~     body fat. The investigators measured decrement of body fat parameters , including abdominal~     fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their~     blood pressure.~   "
101075|NCT01734174|"~     Echocardiography is an ultrasound-based imaging technique which can be performed through the~     esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are~     performed routinely as a monitoring and diagnostic tool at different times in the course of~     one cardiac surgery. The purpose of the study is to compare these two methods of~     echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely~     performed simultaneously. The study will also compare the echocardiography data to a third~     technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.~   "
101076|NCT01734161|"~     Patients who present for scheduled (non-emergent) cesarean section will be given either~     intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal~     anesthetic. The investigators will then compare the incidence of nausea and vomiting and the~     use of rescue anti-nausea medications in both groups. Our hypothesis is that patients~     receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section~     will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours~     following surgery.~   "
101077|NCT01734148|"~     Sleep is a biological process essential for health. Being hospitalized can exacerbate common~     sleep difficulties in children. Factors that contribute to sleep disturbances during~     hospitalization include environmental, physiological, and psychological factors. Although~     sleep interventions exist for healthy children in the community, interventions aimed at~     hospitalized children need to be developed and piloted with rigorous evaluative methods. The~     primary purpose of this study is to examine the feasibility and acceptability of the RELAX~     TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons~     will be made to examine sleep outcomes between the intervention group and the control group~     including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of~     nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety~     levels and the development of post-hospital maladaptive behaviours.~   "
101078|NCT01734135|"~     This proposal examines use of a clinical reminder to the primary provider of patient with a~     high B type natriuretic peptide but no prior imaging.~      Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve~     Heart Failure Management in Patients with High BNP Values and Unknown LVEF.~   "
101079|NCT01734122|"~     The purpose of this study is to determine the changes in quality of life and degree of~     tremor for patients with essential tremor or Parkinsonian tremor who are treated by~     stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed~     Description below for more information.~   "
101080|NCT01734109|"~     Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and~     promotes granulation tissue and angiogenesis. Despite these known means for facilitation of~     wound management, further research is needed to examine whether this modality is superior to~     other currently used options, thus defining clear indications for and benefits of NPWT. This~     would also help establish the role of combination therapy, using NPWT with simultaneous~     irrigation or other forms of dressings. This study aims to compare treatment efficacy of~     NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of~     care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is~     comparison of reduction of wound volume between the three treatment arms; and secondary~     endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.~   "
101090|NCT01733966|"~     The primary outcome measure is to compare efficacy of an association of~     Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid~     during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among~     Adults in clinical and biological cure.~      The cure rate will be evaluated at the second visit (14 days after the inclusion visit)~   "
101091|NCT01733953|"~     Adult survivors of childhood cancer are at high risk of developing cardiovascular disease.~     Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause~     damage to the surface of the artery wall called the endothelial layer, leading to the~     induction of atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase~     inhibitors, or statins, improve endothelial function independent of cholesterol-lowering. In~     addition, statins have been shown to reduce arterial stiffness and slow arterial thickening.~     Despite strong evidence supporting the vascular benefits of statins in many different~     patient populations, these medications have never been studied in cancer survivors.~     Therefore, the overall objective of this study is to evaluate the effects of statin therapy~     on vascular health in young adult survivors of childhood cancer.~      Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic~     leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized,~     double-blind (participants and investigators), placebo-controlled pilot clinical trial~     comparing the effects of atorvastatin versus placebo on endothelial function and other~     measures of vascular health.~      Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit~     artery endothelial function in young adult survivors of childhood cancer. The investigators~     hypothesize that, compared to placebo, atorvastatin will significantly increase brachial~     artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and~     non-Hodgkin's lymphoma.~   "
101092|NCT01733940|"~     Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in~     intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can~     decrease the catheters colonization, closely related to infection thereof.~      Objective: To determine the efficacy of the dressing Tegaderm CHG dressings versus~     Tegaderm IV dressings in reducing the risk of colonization of central intravascular~     catheters in the intensive care unit (ICU).~      Methods: Randomized controlled trial with blinding professional who reviews the main~     outcome. The study included patients over 18 years, indicating the central intravascular~     catheter implantation in the ICU or in the operating room, prior informed consent. Excluding~     subjects with positive blood culture at the time of catheter implantation.~      The estimated sample size is 398 patients, with a confidence level of 95% and a statistical~     power of 80%. The study protocol was approved by the ethics committee of the hospital.~      Be made prospectively followed subjects from study entry until catheter removal collecting~     information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site~     and removal, reason for withdrawal and microbiological information.~      For statistical analysis, a model is adjusted multivariate logistic regression, determining~     the interaction of variables with the likelihood ratio test and confusion by switching~     between the crude and adjusted effect greater than 10%.~      Results and conclusions: The recruitment has started in November 2012 and is scheduled for~     completion in March 2013. This study will determine whether these new dressings are~     effective in our environment.~   "
101093|NCT01733927|"~     The purpose of this study, conducted in Santiago-Chile, was to:~        1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when~          compared to ELISA;~        2. Track the number of people in the study who returned for their ELISA test HIV results;~          and~        3. Analyze the perception among participants of the use of OQA compared to ELISA testing~          for HIV screening.~   "
101094|NCT01733914|"~     According to traditional Chinese medical theories, a variety of acupuncture formulas can~     treat diseases such as pain. For example, stimulating acupoints either local or distal to~     the pain site has been proposed under some conditions. We hypothesize that stimulating~     acupoints contralateral to the pain site can successfully treat chronic shoulder pain.~   "
101095|NCT01733901|"~     To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and~     the recurrence rate of a composite of cardiovascular event(including angina, myocardial~     infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting)~     in patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce~     the risk factors for coronary heart disease.~   "
101096|NCT01733888|"~     Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride~     during the tooth development.~      The present study is planned to evaluate the efficacy of Resin Infiltration technique in~     improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin~     infiltration is a novel method that has shown its efficacy in improving the esthetics of~     White spot lesions (WSLs) per say and post orthodontics WSLs in different both in-situ and~     in-vivo studies. The Resin Infiltration technique is also known to stop the progression of~     caries in non cavitated lesions in both, smooth surface and interproximal lesions.~      Therefore, the following trial will be conducted to assess the esthetic improvement of~     fluorosed permanent anterior teeth after resin infiltration and compare it with standard~     bleaching procedure and a combination of bleaching and Resin infiltration therapy in~     children with damaged teeth by fluorosis.~   "
101097|NCT01733875|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral~     dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy~     subjects~   "
101098|NCT01733862|"~     This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City~     (administrative district), Japan, where RV vaccines have been introduced since November 2011~     and financial support for vaccination costs by Nagoya city, Japan have been implemented from~     October 2012.~   "
101099|NCT01733849|"~     This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the~     primary care settings of both Bulgaria and Latvia in children less than 5 years of age.~   "
101100|NCT01733836|"~     To determine whether the use of metformin in patients with low-risk prostate cancer can~     delay progression to clinically significant prostate cancer.~   "
101141|NCT01733290|"~     This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients~     with dysfunctional voiding. The results of this study can provide further information for~     patient selection and therapeutic duration.~   "
101101|NCT01733823|"~     P16 negative cancers continue to have a dismal prognosis despite advances in the treatment~     of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and~     nimorazole has been shown to improve local control. The purpose of the study i to~     investigate the level of co-morbidity and performance status (PS) that allows the~     combination of all of the above means of treatment intensification~   "
101102|NCT01733810|"~     The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on~     the production of inflammatory cytokines that lead to reflux esophagitis.~   "
101103|NCT01733797|"~     The trial will compare exercises using Therabite® versus wooden spatulas to prevent or~     relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.~   "
101104|NCT01733784|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Some studies have~     shown that there is progressive narrowing of the pharyngeal airway across breaths during~     expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The~     investigators will assess the viscoelastic properties of the pharyngeal airway and its role~     in PEN.~   "
101105|NCT01733771|"~     This study evaluates the effects of complementary medicine (CAM) treatments on patient~     reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such~     as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators~     compare outcomes between two groups: Standard of care (treatments that are provided commonly~     in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both~     quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea,~     wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.~   "
101106|NCT01733758|"~     This study is designed to examine the efficacy and safety of 2 dose levels of weekly~     subcutaneously injected albiglutide compared with placebo and an open label reference arm of~     daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes~     mellitus.~   "
101107|NCT01733745|"~     The purpose of this study was to assess the efficacy of the SYSTANE® family of products~     (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on~     meibomian gland functionality in subjects with lipid deficiency related to evaporative dry~     eye as compared to the standard of care warm compresses.~   "
101108|NCT01733732|"~     The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to~     improve comfort in subjects with dry eyes.~   "
101109|NCT01733719|"~     LAY SUMMARY~      A type of gullet cancer (oesophageal adenocarcinoma) has become the 5th commonest UK cause~     of cancer death. Unfortunately, by the time patients have symptoms, the cancer is often~     incurable. People with Barrett's oesophagus (change of gullet lining occurring in some with~     acid reflux) at risk of this cancer can have regular check-ups, involving examination~     through an endoscope (an instrument inserted by mouth, under mild sedation if required). A~     small proportion of people with Barrett's develop further changes (which might become~     cancer) in the gullet lining; if they do, it is important to remove the affected tissue~     before cancer develops, or when it is at an early stage.~      There are several ways of removing this tissue but the investigators do not know which is~     best. The standard treatment is surgery, but there is a small risk of dying from the~     operation, and patients often suffer complications affecting them for a year or more~     afterwards. Two endoscopic treatments do not involve surgery. Both involve removing visible~     abnormalities by a technique called endoscopic resection, followed by cauterising the~     remaining Barrett's gullet lining by 1 of 2 techniques. One is recommended by the National~     Institute for Health and Clinical Excellence, but it is expensive and less widely available~     than the second. No-one has compared these treatments with each other, nor with surgery, in~     randomised trials (the most reliable way of deciding which is best). Patient groups say they~     would prefer to avoid surgery if the alternative works, and have encouraged us to do trials.~      This feasibility study is a vital step towards two trials: (a) a trial to compare the two~     non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will~     help us find out whether it will be possible to enroll and retain enough patients by using~     several centres, and to identify/resolve any other potential barriers to recruitment and~     retention, including exploring viewpoints of patients and surgeons.~   "
101110|NCT01733706|"~     The aim of this study is the evaluation of early smoking reduction or cessation by means of~     no nicotine electronic cigarette added to standard counselling.~   "
101111|NCT01733693|"~     The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two~     types of opioid addiction treatment, on the ability to think and reason among people~     addicted to opiates, and who are either HIV negative or HIV positive; and (2) investigate~     whether HIV infection changes the way opioid treatment affects the ability to think and~     reason. The investigators hypothesize that there will be (1) significant improvement in~     thinking and reasoning ability after starting buprenorphine treatment compared to methadone~     treatment, among participants with and without HIV at 2 and 4 months compared to baseline;~     and (2) HIV positive participants will demonstrate significant improvement in thinking and~     reasoning ability at 2 and 4 months compared to baseline, but that their thinking and~     reasoning ability will still be lower than HIV negative participants.~   "
101112|NCT01733680|"~     The investigators are proposing to test a medication derived from our prior studies of the~     gene SLC9A9. This one gene makes NHE proteins that control how we learn and remember items,~     which is impaired in ADHD and may cause an inability to plan, prioritize,~     self-monitor,inhibit, initiate, self-correct, or control one's behavior. The investigators~     now propose to investigate the therapeutic utility of an NHE inhibitor, amiloride~     hydrochloride, for the treatment of attention deficit hyperactivity disorder (ADHD) in~     medication-naïve adults with ADHD.~   "
101113|NCT01733667|"~     The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack~     after FESS.~   "
101114|NCT01733654|"~     The purpose of the study is to explore the efficacy of 6 weeks treatment of an~     investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with~     major depression.~   "
101115|NCT01733641|"~     Healthy volunteers without concussion, currently participating in non-or-limited contact~     sports teams at Emory University will undergo Display Enhanced Testing for Concussion and~     mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and~     day 90. Prior to enrollment participants will be allocated to the test-retest arm or the~     exercise arm.~   "
101116|NCT01733628|"~     GEI-BEV-2011-02 is a multicenter, post-authorization observational with prospective~     follow-up (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or~     metastatic colorectal cancer. The hypertension will be evaluated as a predictor of efficacy~     of bevacizumab associated with chemotherapy, in terms of progression-free survival (Main~     endpoint).~      The duration of the study will be approximately 42 months.~   "
101117|NCT01733615|"~     The purpose of this study is to find out more about some of the unusual chemicals (called~     oligosaccharides) that can occur naturally as a result of processes in the body. Researchers~     want to look at how these chemicals change with time and how they change between different~     patients with MPSIVA. These unusual chemicals were recently discovered in the urine from~     patients with MPSIVA. The investigators would like to study these chemicals before a~     specific enzyme replacement therapy is used. If the investigators understand how these~     chemicals change, the investigators may be able to use them to monitor this condition in the~     near future as well as help doctors know whether certain therapies work well in their~     patients.~   "
101118|NCT01733602|"~     The primary aim for the study is to determine whether transcranial direct current~     stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims~     are to determine whether tDCS combined with CT causes larger transferable improvements on~     non-trained tasks (i.e., generalisation effects) and whether these generalisation effects~     are maintained over time (i.e., maintenance effects).~      Specific hypotheses are:~        1. CT combined with active tDCS will produce greater training gains on CT tasks compared~          to a similar control group receiving CT with sham tDCS.~        2. CT combined with active tDCS will produce greater generalisation effects on non-trained~          cognitive tasks compared to CT with sham tDCS.~        3. The cognitive improvements gained by patients from both interventions will be~          maintained over 1 month follow-up.~   "
101119|NCT01733589|"~     Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the~     local control of tumors, especially the squamous cell carcinomas. Preclinical models have~     shown that Endostar may transiently normalize the tumor vasculature to make it more~     efficient for oxygen delivery, thereby providing a window of opportunity for enhanced~     sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and~     efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT~     regimen in patients with unresectable stage III NSCLC.~   "
101120|NCT01733576|"~     This project will use a new form of non-invasive brain stimulation called high-definition~     transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form~     of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for~     more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of~     the brain important for learning and memory will improve verbal learning and memory compared~     to sham HD-tDCS.~   "
101121|NCT01733563|"~     The objective of this study is to investigate the impact of sugar sweetened beverages on the~     fat metabolism of healthy young men. It is well known that consumption of beverages~     sweetened with fructose is associated with different health risks such as type 2 diabetes.~     The present study has been designed to dissect differences in the metabolic pathways of~     fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose~     diets. During a period of seven weeks subjects will consume either fructose, glucose or~     sucrose sweetened beverages or continue their usual drinking habits. During these seven~     weeks there will be different metabolic investigations using stable isotope tracers. First,~     the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid~     synthesis will be measured. During all examinations there will also be substrate- and~     energy-utilization measurements by indirect calorimetry, blood analysis and morphometric~     measurements. Based on the literature main hypotheses are: Fructose enhances de novo~     lipogenesis postprandially and also in the fasting state significantly more than glucose by~     enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via~     downregulation of oxidative enzymes.~   "
101122|NCT01733550|"~     The purpose of this study is to compare glaucoma patients' own I Care measurements by the~     standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.~   "
101123|NCT01733537|"~     The purpose of this study is to determine whether providing motorcycle taxi drivers with a~     free reflective fluorescent vest will result in increased use of reflective or fluorescent~     clothing compared to education about wearing reflective or fluorescent clothing alone.~   "
101124|NCT01733524|"~     The investigators' long-term goal is to discover novel, inexpensive and feasible strategies~     to improve the management and well-being of youth with T1DM. The specific objective of this~     proposal is to quantify the impact of responsible pet ownership on the glycemic control and~     health related quality of life in youth with T1DM.~   "
101125|NCT01733511|"~     Emergency departments are established in 20 hospitals in Denmark in order to improve the~     quality for the acute patients.~      A group of acute patients which require timely assessment and plan from a specialist is~     patients with abdominal pain.~      the aim of the present study is to evaluate whether the admission of the group of patients~     to emergency departments reduces the time to doctor, specialist and plan compared to the~     traditional admission to a surgical acute ward.~   "
101126|NCT01733485|"~     Asthma is an inflammatory disease, which means it causes swelling in the lungs to cause~     shortness of breath and/or wheezing. There are several asthma medications that help to~     reduce this problem.~      The objective of this research study is to characterize the presence of electrophilic fatty~     acids in the bronchial airway of subjects with controlled asthma at baseline and after~     treatment with Aspirin, Indomethacin, or no treatment at all. The presence of electrophilic~     fatty acids may indicate inflammation. Aspirin and Indomethacin are known to respectively~     increase and inhibit the formation of electrophilic fatty acids. By gaining a better~     understanding of how electrophilic fatty acids work and how they respond to different~     treatment, researchers hope to be able to find better ways to lessen airway inflammation in~     asthma in the future.~   "
101127|NCT01733472|"~     The purpose of this study is to determine whether general anaesthesia or regional~     anaesthesia is best for patients undergoing Total Hip Arthroplasty.~   "
101128|NCT01733459|"~     This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with~     6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in~     improving reproductive parameters and to evaluate the safety of DLBS3233 in women with~     polycystic ovary syndrome compared with metformin, as an active control.~   "
101129|NCT01733446|"~     The investigators data reveal an important new observation regarding the recovery of~     breathing during emergence from general anesthesia: respiration resumes as a prolonged~     abdominal expiration event.~      The present study aims to further clarify the physiology of recovery of breathing with the~     addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of~     two different recovery paradigms.~   "
101130|NCT01733433|"~     The main goal of this study is to evaluate the effect of taping on postural control during~     dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the~     study. Several questionnaires regarding anthropometric data, medical history, activity level~     and functional status will be filled in by the participants. Postural control will be~     measured using a force plate and an optoelectronic system to capture lower limb kinematics.~     Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they~     have to maintain their balance for 10 seconds after landing. 5 good trials of each movement~     will be captured. Subjects with CAI will perform these exercises with and without tape.~     Hypothesis is that subjects with CAI that tape will enhance postural control.~   "
101131|NCT01733420|"~     A clinical trial to evaluate and compare three different products used for endodontic~     treatment (taking the infected nerve out of the teeth) of primary teeth.~      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the~     former iodoform product.~   "
101132|NCT01733407|"~     In hereditary sensory and autonomic neuropathy type 1 (HSAN1) the investigators recently~     discovered the accumulation of two neurotoxic sphingolipids. It appears that these lipids~     arise as the mutant enzyme has a reduced affinity for its normal preferred substrate~     L-serine. The investigators now plan to perform a two year study of L-serine supplementation~     to correct the biochemistry and neurological disease in humans with HSAN1. In the course the~     investigators will also establish correlations between an existing neurological rating scale~     of sensory neuropathy and intraepidermal nerve fiber density.~      Funding Source - FDA OOPD~   "
101133|NCT01733394|"~     The United States Food and Drug Administration (FDA) has specific rules which generic drug~     companies must follow to get a generic copy of a seizure medication approved. Currently, FDA~     approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and~     who take just one dose of the generic drug followed by a series of blood tests. Some people~     with epilepsy and their physicians have complained about side effects or loss of seizure~     control when taking generic drugs, but no one knows if these complaints are truly because of~     problems with the generic drugs.~      This research is to determine whether several different generic versions and the brand~     version of the medication lamotrigine perform in a similar way when given to people with~     epilepsy.~      The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be~     tested are approved by the FDA for the treatment of seizures.~   "
101134|NCT01733381|"~     Aerobic exercise impacts bodily processes implicated in the pathophysiology of major~     depression. Consistent with these effects, aerobic exercise in general, and running in~     particular, has been repeatedly shown to have both immediate mood elevating and longer-term~     antidepressant effects. To the investigators' knowledge, all studies of running as a~     therapeutic intervention for mood have had subjects run in standard running shoes, despite~     increasing evidence that running barefoot or in shoes with minimal effect on foot strike~     (i.e. minimally shod) leads to marked changes in how people run in ways that might have~     physiological effects of relevance to health. Thus, nothing is currently known about~     differences in effects on depression-relevant physiological or emotional functioning between~     running either barefoot or minimally-shod vs. running in standard running shoes (hereafter~     called shoed). The current pilot study is designed to begin addressing these issues by~     examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic~     nervous system (ANS) functioning and mood state.~   "
101135|NCT01733368|"~     Optimization and evolution of the patient will be evaluated over 6 months after the implant.~   "
101136|NCT01733355|"~     [F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the~     human brain.~   "
101137|NCT01733342|"~     To compare the performance of domestic chemoport and imported chemoport~   "
101138|NCT01733329|"~     Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in~     women with risk factors for uterine atony decreases the need for additional uterotonic~     medications, uterine atony and postpartum hemorrhage.~      Design: randomized, double-blinded, placebo-controlled trial.~   "
101139|NCT01733316|"~     The purpose of this study is to gather information about the effectiveness (how well it~     works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103,~     compared to the already-approved drug cystinosis patients are taking called Cystagon®.~      In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of~     Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active~     ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon®~     does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood~     tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell~     (WBC) cystine after taking study drug. WBC cystine is a laboratory test used to find out if~     cysteamine bitartrate is reducing cystine levels in the body. The second test is~     pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the~     drug.~      RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from~     the stomach, RP103 is designed to be absorbed from the small intestine. This may make the~     effects of the drug last longer, so that it can be taken twice a day instead of four times a~     day like Cystagon®.~      Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study~     participants who experience bad breath with Cystagon® will be asked if they would like to~     participate in an optional halitosis substudy to investigate this issue by collecting some~     extra PK blood samples.~   "
101140|NCT01733303|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury or mortality. Identifying the~     factors related to falls occurring within this population is essential for the development~     of effective regimes for fall prevention. Studies have shown that muscle quality and good~     posture alignments are critical for balance control in older adults. People are diagnosed~     with osteoporosis often combining with muscles weakness, and increased spine kyphosis~     leading vertebral, fractures and poor balance control, even falls. Therefore, improving~     muscle quality, strengthening weak muscles and correcting postural alignment are essential~     elements for fracture and fall prevention in older adults with osteoporosis. The long-term~     objectives of this work are to prevent fracture and fall in older adults with osteoporosis~     by improving the function of degenerative muscles using exercise training.~   "
101143|NCT01732198|"~     Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with~     Prevnar 13® over a 28 day period following the injection compared to a single booster of~     ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.~      Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single~     booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of~     ActHIB® co-administered with Prevnar 13®.~      Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®~     following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to~     the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28~     days following injection.~   "
101144|NCT01732185|"~     The aim of this study is to identify genetic abnormalities and molecular pathways associated~     with the occurrence of CCAM.~   "
101145|NCT01732172|"~     Men following after proven and treated urethritis, looking for signs of chronic genital~     inflammatory syndrome with oxidative stress.~      This group of patients will be compared to a control group with no urethritis and no history~     of urogenital infection. Monocentric, prospective trial.~      Duration of study : one year~   "
101146|NCT01732159|"~     The purpose of this study is to evaluate the impact of a check list on the rate of late~     cancellation, i.e. the day before or the day of the ambulatory surgery.~   "
101147|NCT01732146|"~     The purpose of this study is to determine the efficacy of high dose Erythropoietin to~     improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.~   "
101148|NCT01732133|"~     Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric~     measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could~     help to detect hypotension.~   "
101149|NCT01732120|"~     The purpose of this research study is to compare the effects on kidney function after~     performing the removal of a kidney tumor with or without clamping the blood vessels during~     surgery.~   "
101150|NCT01732107|"~     This trial will assess the 6-month complete response rate and toxicity profile of oral~     dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3~     mutations or over-expression who are ineligible for or refusing cystectomy.~   "
101151|NCT01732094|"~     The purpose of the present study is to examine the level of ovarian response and the~     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with~     150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.~   "
101152|NCT01733238|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study~     is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to~     characterize anti-tumor activity and collect safety data on patients with relapsed or~     refractory lymphoma.~   "
101153|NCT01733212|"~     SPECIFIC AIMS~        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional~          anesthesia~        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in~          the ginger and placebo groups.~        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups~        -  Quantify patient satisfaction of the ginger and placebo groups~        -  Assess patient expectation of ginger on post-op day three~   "
101154|NCT01733199|"~     This study is composed of a main study and an ancillary one. The objective of the main study~     is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the~     predictive factors for developing a behavioural addiction (BA) secondarily to the~     dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in~     patients with Parkinson's disease.~      3 particular profiles of patients will be established:~        -  BA- : no secondary behavioural addiction~        -  BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome~        -  BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome~      We wish in particular:~        -  To differentiate, among the BA+ subjects, those for who is a DDS from those for who we~          can evoke a side effect of the dopaminergic treatment~        -  To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities~          causing the occurrence of the BA.~        -  To clarify the possible relationship between the dosage and the pharmacodynamics of the~          treatment (especially that of pramipexole) in one hand, and the developing of BA in the~          other hand.~        -  Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability~          (related to the dopamine system), originally from the occurrence of the BA.~      This study has several levels of evaluation, we chose describe the methodology of the study~     in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.~      The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary~     study centered on the pharmacokinetic of the pramipexole (in its immediate release form).~   "
101155|NCT01733186|"~     The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is~     safe and effective in the treatment of articular cartilage defects of the knee as a result~     of ageing, trauma, or degenerative diseases.~   "
101156|NCT01733173|"~     The purpose of this study is to better understand why some children with cancer have~     difficulty speaking after brain surgery. Difficulty speaking may be due to known~     complications to the language centers in the brain. These language centers may be located in~     slightly different places in different people. This study will study which areas may be~     damaged.~   "
101157|NCT01733160|"~     This observational registry will characterize contemporary stroke prevention in Canadian~     adults with atrial fibrillation, and provide clarity in understanding physician preferences~     for the various oral anticoagulants available in the Canadian marketplace. This study will~     determine the patient profiles of those selected for the various therapies available in~     Canada and provide an understanding of the factors involved in drug selection and~     management.~   "
101158|NCT01733147|"~     Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus~     subjects downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to~     anti-inflammatory pathway?~   "
101219|NCT01732354|"~     The investigators aim to clarify the issue of adequate duration of consolidation period of~     Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a~     balance between durable HBeAg seroconversion and avoiding long-term inevitable serological~     or virological recurrence.~   "
101159|NCT01733134|"~     Patients being hospitalized for acute heart failure and already receiving standard therapy~     will be randomized to receive either tolvaptan or placebo, based on the level of copeptin~     measured in their bloodstream. Patients with high copeptin levels will be able to~     participate in the trial, patients with low levels will be excluded. Patients being admitted~     to the observation unit for acute heart failure and already receiving standard therapy will~     be randomized to receive either tolvaptan or placebo without consideration of the copeptin~     level. The hypothesis is that patients receiving tolvaptan will have better improvement of~     shortness of breath than those receiving placebo, within 9 hours of drug administration.~   "
101160|NCT01733121|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854~     (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily~     for the treatment of Tardive Dyskinesia (TD) symptoms.~   "
101161|NCT01733108|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie,~     how the drug affects the body) of a single dose of glyburide.~   "
101162|NCT01733095|"~     Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension~     and is present in approximately 5% of cirrhotic patients. Treatment options include~     prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.~      This study investigates the safety and efficacy of ambrisentan in portopulmonary~     hypertension.~   "
101163|NCT01733082|"~     The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry~     collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,~     fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be~     solicited at selected gestational time points. Structural and functional birth defects~     identified in the perinatal period through one year of life will be collected and~     classified.~      This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk~     Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all~     mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.~   "
101164|NCT01733069|"~     The objectives of this study are to establish the performance characteristics of the AC2~     (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the~     TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and~     reproducibility of the AC2 Assay on the PANTHER System.~   "
101165|NCT01733056|"~     Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients~     receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD~     Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto~        1. Problem of Interest We are proposing to study the effectiveness of vaccines in people~          who are taking drugs that affect the immune system. There are many populations of~          people who have chronic medical conditions that require them to have long-term~          treatment with immunosuppressive medications (drugs that decrease the function of the~          immune system). Examples of these patients include organ transplant recipients,~          patients with immune cell cancers such as leukemia and lymphoma, patients with~          inflammatory disorders such as lupus or scleroderma, and patients with skin conditions~          requiring steroid-based creams, ointments, pills, or injections. Patients who are~          taking these medications should receive appropriate vaccinations such as tetanus~          boosters, influenza vaccines, and pneumonia vaccines. The effectiveness of vaccinations~          depends in large part on a strong response to the vaccine by the immune system. Drugs~          that decrease immune system function therefore, may also decrease the effectiveness of~          vaccines.~        2. How the Problem of Interest will be studied~      We plan to give three different groups of participants influenza vaccinations and measure~     each participant's immune system response through blood tests. The three groups will be:~        1. Healthy people taking no immunosuppressive medications~        2. Patients with skin conditions requiring treatment with azathioprine and currently~          taking no other immunosuppressive agents~        3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis~          factor-alpha) and currently taking no other immunosuppressive medications.~      All participants will be between 18 - 89 years old and will not have had influenza~     vaccination within the previous six months. We will administer the vaccination on day 0. We~     will take blood samples on days 0, 7, and 28 following vaccination. We will use these blood~     samples to measure the amount of antibodies produced to the vaccine and the response of~     specific immune system cells known as B-lymphocytes. Using statistical methods, we will~     compare these findings between the three groups of participants to determine if differences~     in response to the vaccination exist.~      3. How the research will advance scientific knowledge and/or human health To our knowledge~     there is no scientific data available regarding the effectiveness of vaccinations in~     patients receiving only one specific immunosuppressive medication. We will also be using new~     techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This~     research could potentially help guide vaccination strategies for people requiring~     immunosuppressive medications and prevent infectious disease in these populations as well as~     the general population.~   "
101166|NCT01733043|"~     The objective of this study is to determine the effect of dexmedetomidine infusion on the~     Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep~     apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with~     obstructive sleep apnea (OSA).~   "
101167|NCT01733030|"~     PROJECT SUMMARY:~      PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life~     threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults.~     One core symptom of PTSD is intense psychological distress in the presence of stimuli that~     resemble one or more aspects of the trauma experience (DSM-IV). This phenomenon referred~     to as stimulus generalization has received surprisingly little empirical testing in the~     context of clinical anxiety in general, and PTSD more specifically. The current proposal~     represents the first effort to study the neurobiology and pharmacology of this PTSD-relevant~     learning phenomenon across those with and without PTSD. The objective of this particular~     proposal is to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms~     associated with generalization of conditioned fear and 2) examine the pharmacologic~     modifiability of levels of generalization using a partial agonist at the NMDA receptor~     complex (D-cycloserine) shown to increase discrimination of CS+ (danger cue) and CS- (safety~     cue) in animal studies.~   "
101168|NCT01733017|"~     The purpose of is to test the effects of a 6-month nutrition intervention of dietary sodium~     reduction combined with supplementation of lycopene and omega-3 fatty acids on heart failure~     symptoms, health-related quality of life, and time to heart failure rehospitalization or~     all-cause death.~   "
101169|NCT01733004|"~     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3~     design, evaluating MM-141 at varying dose levels and frequencies.~   "
101170|NCT01732991|"~     The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the~     treatment of benign prostatic hypertrophy (BPH) as recommended.~      The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The~     underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal~     effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced~     ultrasound the necrosis.~   "
101220|NCT01732341|"~     This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system~     (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent~     is not worse than the Vision stent.~   "
101171|NCT01732978|"~     The crying baby is a sound signal including information relating to this individual identity~     or related to its physiological or motivational state.~      The objective of the study is to determine the implementation of the recognition of~     individual tone of the baby by his parents and acoustic modulation of the baby based on~     parental response.~      The detailed study of the acoustic structure of crying and analysis of parental perception~     will determine the dynamics during the first weeks of life of this recognition, and the~     influence of factors such as parental presence, or breastfeeding .~      For this study is organized in three stages: first, the recording of the baby's crying~     Secondly, a listening test parental soundtracks and third analysis of the acoustic structure~     of crying and parental response.~   "
101172|NCT01732965|"~     To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B~     is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.~   "
101173|NCT01732952|"~     This cross-sectional, non-interventional, and observational study will assess the lipid~     profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients~     achieving treatment to goal according to national and international lipid management~     guidelines) during a single visit to their physicians on an outpatient basis in 6~     representative geo-economic regions in China: Northeast, North, East, South, Southwest, and~     Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching~     hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community~     hospitals/health centers). The investigators will primarily be cardiologists,~     endocrinologists, neurologists, gerontologists, internists, or other physicians who are~     representative of the general population of physicians managing patients with dyslipidemia~     and/or at high risk for cardiovascular events likely to be treated with lipid-modifying~     drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease~     and cardiovascular treatments will be documented in a single visit through patient clinical~     examination and chart review.~      DYSIS-China is part of a string of epidemiological studies that share the same master~     protocol, which has been conducted in different countries mainly in Europe and Canada. The~     analysis of the pooled studies including overall data and cross-country comparisons is the~     subject of a distinct protocol.~   "
101174|NCT01732939|"~     The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for~     invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines~     plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.~   "
101175|NCT01732926|"~     This study will evaluate the the addition of idelalisib to bendamustine/rituximab on~     progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin~     lymphoma (iNHL).~   "
101176|NCT01732913|"~     This study is to evaluate the effect of the addition of idelalisib (GS-1101) to rituximab on~     progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin~     lymphoma (iNHL).~   "
101177|NCT01732900|"~     The purpose of this study is to determine the performance of a genetic assay, GemART, in~     cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in~     vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as~     measured by the implantation rate of embryos transferred.~   "
101178|NCT01732887|"~     In this study we are testing computer-based brain fitness exercises. The games are designed~     to improve people's cognitive abilities brain functions, like memory, concentration, and~     ability to do two things at once. We are testing whether this cognitive training brain~     exercises will improve understanding of spoken sentences speech comprehension in people who~     use cochlear implant and/or hearing aids. We predict that cognitive training will improve~     speech comprehension in cochlear implant and/or hearing aid users.~   "
101179|NCT01732874|"~     The purpose of this research study is to find out whether preterm infants are receiving~     enough of the essential and long chain fatty acids important for brain development and~     immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids~     and different milk sources have different compositions. We would like to evaluate lactating~     mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of~     their blood and breastmilk samples after they have been supplemented with a currently used~     fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM)~     Nutritional Lipid) The DHA supplement is available over the counter.~      The information learned from this research study may benefit other mothers and babies in the~     future. The information could help make sure premature babies are receiving the right~     nutrients they need for appropriate growth and development.~   "
101180|NCT01732861|"~     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine~     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated~     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the~     combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).~   "
101181|NCT01732848|"~     The purpose of this study is to determine the rate of kidney or heart impairment, if any, in~     subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials~   "
101182|NCT01732835|"~     This investigation is a prospective, non-randomized, multi-center trial to evaluate the~     extended safety and performance of the HAART model 300 annuloplasty ring when used to~     surgically repair the aortic valve using a 3-D intra-annular mounting frame.~   "
101183|NCT01732822|"~     The purpose of this study is to compare the effects of ticagrelor and clopidogrel in~     patients with Peripheral Artery Disease.~   "
101184|NCT01732809|"~     The purpose of this study is to assess the fields of effect (FE) of ABO and ONA at the same~     labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.~   "
101185|NCT01732796|"~     The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically~     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.~   "
101245|NCT01731899|"~     Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is~     a new antidepressant with sleep-promoting properties. The objective of this study include~     the assessment of agomelatine therapy in patients with depression and fibromyalgia both on~     the severity of depressive symptomatology and sleep quality.~   "
102671|NCT01713205|"~     The purpose of this study is to evaluate a clinically and economically most effective~     diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample~     of severe trauma patients.~   "
101186|NCT01732783|"~     This is a multicenter, observational prospective cohort study in France and Germany.~     Treatment centres with a focus on treating subjects with mCRC will be prospectively defined~     for potential inclusion in the study. Eligible subjects will be enrolled and have~     retrospective data collected from Baseline up to the point of enrolment. All subsequent~     chemotherapy cycles and Vectibix® doses will be recorded prospectively. Each subject will~     have data collected until approximately 30 days after the end of Vectibix® treatment, death,~     withdrawal of consent, loss to follow-up or up to 12 months from the first dose of~     Vectibix®, whichever occurs first.~   "
101187|NCT01732770|"~     This study will compare the effectiveness of denosumab treatment every 6 months with once~     yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.~   "
101188|NCT01732757|"~     This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™~     (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular~     itching associated with allergic conjunctivitis.~   "
101189|NCT01732744|"~     To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of~     complete denture biofilm, comparing it with two products available on the market (sodium~     hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were~     instructed to brush their dentures after meals and once a day, for a period of 07 days,~     immerse them in the following solutions: A - Control: Physiological solution(20 minutes). B~     - Polident alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor~     bean-based solution(20 minutes). The participants immersed their dentures in each of the~     solutions, according to a randomized sequence. For biofilm quantification, before (Baseline)~     and after the use of each product, the internal surfaces of maxillary complete dentures were~     revealed (1% neutral red), photographed and the stained biofilm was quantified with the aid~     of software (Image Tool 3.0). After concluding measurements of the areas (total and~     biofilm), the percentage of surface covered by biofilm of the complete denture was~     calculated .~   "
101190|NCT01732731|"~     The purpose of this project is to examine if early exposure to intensive, short-term~     locomotor treadmill training (LT) in young children with neuromotor impairment will help~     develop walking skills earlier, decrease the amount of outside assistance needed (such as a~     walker or crutches) as compared to children with neuromotor impairment who receive~     traditional physical therapy intervention.~   "
101191|NCT01732718|"~     The purpose of this research study is to learn about the effect of the drug, atorvastatin,~     on blood vessels in patients with sickle cell disease.~      The primary hypothesis is that endothelial dysfunction is an important contributor to the~     pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will~     improve endothelial dysfunction, decrease levels of sFLT-1, and decrease albuminuria in SCD~     patients.~      Participants will be individuals with sickle cell disease, age 18 to 60, who have some~     degree of albuminuria. A total of 19 subjects, males and females, will be enrolled. The~     study is made up of Screening, Treatment, and Follow Up phases and has a cross-over design.~     After patients are screened for eligibility, they will be randomized to receive atorvastatin~     or placebo in the initial six-week treatment period. When that is complete, there will be a~     four-week washout period before they begin another six-week treatment period. In the second~     treatment period, they cross-over to the other treatment arm. Four weeks after the end of~     the second treatment period, follow-up safety assessments will be done.~   "
101192|NCT01732705|"~     The purpose of this study is to determine the effect of High Intensity Interval Training~     (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.~   "
101193|NCT01732692|"~     To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5~     colon segments prior to colonoscopy.~   "
101194|NCT01732679|"~     A descriptive study of the stroke rehabilitation content in specialized clinics in seven~     countries: procedures for admission to rehabilitation, services available and provided to~     patients, as well as duration of the stay and discharge routines. An observational study of~     changes in regard to the physical function, quality of life and psycho-social factors in~     stroke patients before and after specialized rehabilitation~   "
101195|NCT01732666|"~     Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is~     defined as paradoxically lowering the threshold of pain after the exposure of opioid.~     Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery.~     However, OIH was reported to occur after surgery when large amount of remifentanil was~     administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic.~     Nefopam has been reported to have analgesic and anti-hyperalgesic effect.~      The investigators hypothesized that nefopam administration could prevent OIH or reduce the~     severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam~     on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.~   "
101196|NCT01732653|"~     The proposed randomized controlled trial will evaluate the effects of treadmill training~     augmented with virtual reality on fall risk.~      300 older adults with a history of falls will be recruited to participate in this study.~     This will include older adults (n=100), patients with mild cognitive impairment (MCI)~     (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly~     assigned to the intervention group (treadmill training with virtual reality) or to the~     active-control group (treadmill training without virtual reality). Each person will~     participate in a training program set in an outpatient setting 3 times per week for 6 weeks.~     Assessments will take place before, after, and 1 month and 6 months after the completion of~     the training.~   "
101221|NCT01732328|"~     Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium~     intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and~     maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate~     the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of~     lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and~     neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus~     vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth~     parameters are assessed by standard ultrasound techniques at mid and late gestation.~     Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months~     postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months~     postpartum.~   "
101197|NCT01732640|"~     Trial Objectives:~      The objective is to investigate the efficacy and safety of afatinib with induction~     chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III~     or IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx.~      Primary Objective Phase I The primary objective of the phase I portion of the trial is to~     determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral~     afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21~     days as an induction regimen.~      Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to~     estimate the objective tumor response rate and toxicity with induction therapy in patients~     treated on the afatinib dose determined in Phase I.~      Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall~     response to entire treatment after completion of CRT, 2) progression-free survival (PFS)~     rate at 2 years, and 3) overall survival (OS) at 2 years.~   "
101198|NCT01732627|"~     Primary objectives:~        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,~          measured by serum bactericidal assay using human complement (hSBA) and baby rabbit~          complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune®~          - A/C/Y/W-135.~        -  To describe the safety profile of a single dose of MenACYW conjugate vaccine or~          Menomune® - A/C/Y/W-135.~   "
101199|NCT01732614|"~     This trial seeks to prove that sub-lethal laser power levels are as effective and less~     damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of~     diabetic patients with a disease duration of 20 or more years and is one of the most~     frequent causes of vision loss in this population. The Early Treatment Diabetic Retinopathy~     Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment~     of clinically significant macular edema, reducing the incidence of vision loss by~     approximately 50% at 3 years' follow-up.~   "
101200|NCT01732601|"~     This study will identify the effectiveness of an intensive treatment program for teens who~     are at high risk for harming themselves.~   "
101201|NCT01732588|"~     The purpose of this study is to determine the bioavailability of nanoparticulate OZ439~     delivered to the proximal small bowel (PSB) via the Enterion™ capsule relative to oral OZ439~     suspension (current powder in bottle [PIB]) and oral nanoparticulate OZ439.~      The study will also characterise the plasma concentration time profile of OZ439 when~     delivered via Enterion capsule to the PSB in comparison with OZ439 PIB formulation delivered~     orally and nanoparticulate OZ439 delivered orally Safety and tolerability of OZ439~     formulations will be determined following delivery to the PSB and administered orally~   "
101202|NCT01732575|"~     This RCT study addresses the topic of improving the possibilities for people with severe~     mental illness (SMI) to be engaged in meaningful daily occupations at community-based~     activity (CBA) centers. Meaningful occupation, which includes not only work-related~     activities, but also leisure, household and social activities, is assumed to generate health~     and wellbeing. It is well established that there is a relationship between satisfaction with~     daily occupations and well-being.~      A Swedish mental health care reform stated that the social services should provide~     meaningful daily occupations to people with SMI. However, evaluations of the effects of the~     reform conclude that the target group's needs for meaningful daily occupation have not been~     met.~      Thus, on the basis of governmental reports and evaluations, there is an urgent need for~     improving the quality of the activities and support offered at CBA centers. Therefore, the~     overarching aim of this project is to develop and implement an intervention method for~     improving the activities offered and support given at CBA centers, and evaluate the outcomes~     of that intervention.~      Specific aims~        -  Developing and implementing an intervention that means reorganization of CBA centers in~          such a way that they become enriched with characteristics that have been identified as~          rewarding and meaningful in previous research.~        -  Evaluating the outcome of that intervention on:~             -  the unit level, i.e., in terms of changes in the characteristics of the CBA~               centers,~             -  the individual level, in terms of changes among the consumers regarding~               satisfaction with the activities at the CBA center, perceived control, social~               interaction, quality of life, etc.~      Cluster randomization is used. Day centers are randomized to either giving the new~     intervention (enrichment) or continuing with care as usual during the study period,~     which is 14 months. This means that all participants in a day center get the type care their~     specific day center offers during the study period.~   "
101203|NCT01732562|"~     Patients from the Joint Replacement Institute scheduled to undergo primary total knee~     replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC),~     University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative~     measures and demographic information and a cost analysis will be explored at the PAC for~     each patient. Patients will be randomized with the treatment group receiving access to a~     web-based, e-learning intervention. Postoperatively all patients will be asked to complete~     questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.~      Objectives~      The first primary objective is to compare the effect of two methods of providing patient~     education on expectations of surgical outcome in total knee replacement (TKR) patients.~      The second objective is to compare the effect of two methods of providing patient education~     on satisfaction with surgical outcome in TKR patients.~      The intervention of interest is an e-learning education program that spans both the~     preoperative and postoperative time period. The control condition will be the current method~     of patient education provided at the hospital study site.~      Hypothesis: Objective One~      More change in patient expectations will occur between preoperative and one year~     postoperative in the e-learning educational intervention group.~      Hypothesis: Objective Two~      More change in patient satisfaction will occur between preoperative and one year~     postoperative in the e-learning educational intervention group.~   "
101204|NCT01732549|"~     The purpose of this study is to confirm that tasquinimod used as maintenance therapy is~     active and tolerable in patients with metastatic castrate-resistant prostate cancer not~     progressing after a first chemotherapy with docetaxel.~   "
101205|NCT01732536|"~     The purpose of the study is to determine whether a steroid-eluting sinus implant is~     effective in improving chronic sinusitis symptoms in patients who experience recurrent~     blockage of the sinuses by polyps sometime after sinus surgery.~   "
101222|NCT01732315|"~     This protocol describes a study about vaccination uptake among adolescents. The purpose of~     the study is to determine whether parents who receive email reminders will be more likely to~     obtain Tdap (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus),~     meningococcal, and influenza vaccines for their adolescent children than parents who do not~     receive email reminders.~   "
101223|NCT01732302|"~     The purpose of this study is to determine whether an educational intervention given towards~     health care providers working in primary health care centers can reduce inappropriate~     prescribing in the elderly patient and thus reduce number and length of drug-related~     hospitalizations as well as number of emergency department visits in this patient group.~   "
111348|NCT01598818|"~     The aim of this study is to test the efficacy of the First-Sight refractive kit designed to~     provide refractive correction of simple hyperopia, myopia and astigmatism with~     autorefraction.~   "
101206|NCT01732523|"~     Atherosclerosis is a chronic, systemic and progressive disease affecting different arterial~     blood vessels in the body. Atherosclerotic lesions silently progress from small plaques to~     severe stenosis and may remain asymptomatic for years. Unstable plaques and stenosis (also~     called vulnerable plaques), however, are prone to rupture leading to myocardial infarction,~     or stroke. The proliferation of the small arteries that are distributed to the outer and~     middle coats of the larger blood vessels (vasa vasorum) and within the atherosclerotic~     plaques (neovascularization) are inherently linked with the atherosclerotic plaque~     development, plaque inflammation and vulnerability. By injecting ultrasound contrast agents~     (microbubbles) into the blood stream, it is possible to detect this microcirculation of the~     vessel wall and the neovascularization within the atherosclerotic plaque using a~     contrast-enhanced ultrasound (CEUS) imaging technique. Particularly, CEUS of the carotid~     artery has been introduced as a non-invasive technique to improve detection of carotid~     atherosclerosis and to evaluate the presence of carotid plaque neovascularization which has~     emerged as a new marker for plaque vulnerability. The project investigates the predictive~     value of the detection of carotid plaque neovascularization on CEUS imaging in patients with~     asymptomatic carotid artery stenosis regarding the progression of the carotid~     atherosclerotic lesion and future vascular events including myocardial infarction, stroke or~     vascular intervention. The investigators hypothesize that neovascularization within the~     carotid lesion will significantly be more pronounced in patients with progressive carotid~     lesions and in patients suffering future vascular events during. The project will support~     the concept that intraplaque neovascularization is associated with plaque instability and~     vulnerability and therefore, the use of CEUS may provide an additional non-invasive, simple,~     safe, and reliable imaging modality to risk stratify individuals. The identification of~     vulnerable that are at increased risk of rupture by identification of intraplaque~     neovascularization is expected to improve the prediction of future vascular events and thus~     allow for better treatment selection. It will help the clinician to further risk stratify~     carotid stenosis. Particularly, it will help to identify unstable carotid stenosis that may~     already benefit from invasive therapy as carotid thromboendarterectomy and stenting.~   "
101207|NCT01732510|"~     This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),~     pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe~     atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum~     tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to~     determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define~     safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.~     The study was terminated early due to business reasons on 08 May 2014; final results from an~     analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,~     immunogenicity) are summarized.~   "
101208|NCT01732497|"~     The purpose of this study is to evaluate hair reduction in the underarms in patients treated~     with the miraDry System.~   "
101209|NCT01732484|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide. In the UK, more than half of people who are over 65 have some cataract~     development in one or both eyes. The only treatment that can restore functional visual~     ability is cataract surgery where the opacified crystalline lens is removed by~     phacoemulsification and an artificial intraocular lens is implanted. It is estimated that~     around 10 million cataract operations are performed around the world each year. Cataract~     operations are generally very successful, with a low risk of serious complications. The most~     common risk is developing a condition called posterior capsule opacification (PCO), which~     causes impaired vision to return.~      During the past two decades, cataract surgery underwent tremendous change and modernisation~     resulting in today's small incision phacoemulsification surgery and a safe technique with a~     short rehabilitation time for the patient. The most frequent long-term complication of~     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,~     refinements in surgical technique and modifications in IOL design and material have led to a~     decrease in the incidence of PCO.~      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial~     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule~     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic~     towards the end of the production process, also called multipiece designs.~      For several reasons such as better ease of use with injector systems and higher efficiency~     in the production process, companies have developed IOLs with open-loop haptics out of one~     block of material, also called single-piece designs. In the case of such single-piece IOLs,~     the haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the~     thick haptics maybe an incomplete closure of the capsule at the optic rim with a reduced~     bending effect of the posterior capsule around the posterior optic edge. Additionally, the~     posterior sharp edge is often discontinuous in the region of the haptic-optic junctions.~     These locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting~     in PCO. Nowadays a multitude of different single piece IOLS are available, many of them~     similar but of course with some differences in regard to the chemical composition of the~     acrylic material and the IOL design.~      The purpose of this study is to compare the intensity of posterior capsule opacification~     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)~     over a period of 3 years.~   "
101210|NCT01732471|"~     This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of~     response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years~     who have phenylketonuria and with elevated blood phenylalanine level of greater than or~     equal to 450 micromole per liter.~   "
101211|NCT01732458|"~     The purpose of this study is to determine the appropriate dosing regimen of aprepitant for~     the prevention of post-operative nausea and vomiting in pediatric participants birth to 17~     years.~   "
101212|NCT01732445|"~     This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in~     treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause~     the body to make more red blood cells. They are used to treat anemia in patients with~     myelofibrosis.~   "
101213|NCT01732432|"~     The purpose of this study is to determine whether a relationship exists between a previously~     established diagnosis of endometriosis and the consecutive risk of developing a clear cell~     or endometrioid ovarian carcinoma. All histopathological records since 1980 with these~     diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed.~     Cancer registry data will be assessed to investigate differences in survival of women with~     endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without~     previous diagnosis of endometriosis.~   "
101214|NCT01732419|"~     Physical exercise training appears effective for low to moderate patients assigned to~     cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical~     activity levels often drop after attending the last supervised rehabilitation session.~      This study will compare home based physical exercise training including telemonitoring with~     regular centre based physical exercise training. Main outcome measures are the change in~     physical activity and the change in physical fitness (peak Oxygen uptake) after the initial~     rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are~     cost-effectiveness, training adherence, health-related quality of life and patient~     satisfaction.~   "
101215|NCT01732406|"~     The investigators hypothesize that treatment of acromegaly will be associated with an~     improvement in quality of life compared to active acromegaly. At the same time, they will~     also be studying the effects of different acromegaly treatments on the quality of life.~   "
101216|NCT01732393|"~     The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of~     and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.~   "
101217|NCT01732380|"~     The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus~     radiotherapy in subjects with inoperable esophageal cancer.~   "
101218|NCT01732367|"~     This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir~     monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B~     patients with Undetectable Hepatitis B Virus DNA~   "
101224|NCT01732289|"~     Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped~     conditions for the elderly. Many factors including genetics, diet, diseases, drugs,~     socioeconomic factors and environmental variables were considered to be related to the~     development of presbyacusis. Evidences have shown that genetic factors play an important~     role on presbyacusis. However, which genes or their genotypes are associated with~     presbycusis remain unknown.~      The aim of this project was to evaluate the association between the genotype of candidate~     genes and presbyacusis by cross-section and case-control study. In the first stage, the~     investigators plan to select 700 healthy subjects older than 50 with symmetric,~     sensorineural hearing loss. The subjects will receive basic otologic examination, pure tone~     audiometry, questionnaire, and genotype analysis. Because gender and age would affect~     hearing loss significantly, The investigators will convert the hearing level of all subjects~     into a gender and age independent Z-score according to ISO 7029 standard. And, The~     investigators define subjects within higher 30 % of Z-score as the presbyacusis group, and~     subjects within lower 30% of Z-score as the control group. Finally, The investigators~     perform Chi square analysis to test the association between genotype of candidate genes or~     their combinations in both groups, and calculate the odds ratio for presbyacusis between~     different genotype of candidate genes. Further more, we will evaluate the effect of genotype~     of candidate genes, environment factors, and gene-environmental interaction on the severity~     of presbyacusis by multivariate logistic regression.~      In the second stage, The investigators wish to know the pattern of genotype and hearing~     level in the high risk families, according to results from the first stage, by description~     and case-control study. The investigators will perform t-test to evaluate the difference of~     Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes,~     environment factors, and gene-environmental interaction on hearing level in high risk~     families by multivariate logistic regression.~   "
101225|NCT01732276|"~     Breast cancer is a heterogeneous disease and can be classified into several distinctive~     subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER),~     progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2)~     overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its~     aggressive clinical behavior and insensitivity toward available targeted treatment~     strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to~     chemotherapy,early relapse with metastatic disease is common and the prognosis is poor.~     Development Of novel treatment strategies is,therefore,needed and the study of other~     potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.~      Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that~     encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the~     HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR~     regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and~     serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies~     including TNBC.Gene expression profiling and immunohistochemical studies have indicated that~     40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this~     subgroup,but EGFR mutation was rare in TNBC.~      By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC~     has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one~     or more limitations including:1) the study population had received heavily pretreatment;~     2)the enrolled patients included several subgroups of breast cancer; 3)the expression of~     EGFR was not clear in the enrolled patients.~      Here, the investigators launch a prospective clinical trial, and about 50 patients with~     triple-negative,EGFR positive metastatic breast cancer that have received at least second~     line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity~     and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in~     the metastatic TNBC.~   "
101226|NCT01732263|"~     The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is~     absorbed by the body and how long it takes to be eliminated from the body in healthy~     subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared~     with subjects with healthy normal liver function.~   "
101227|NCT01732250|"~     The purpose of this study is to determine whether the addition of meropenem to colistin is~     better than colistin alone in the treatment of clinically significant infections caused by~     multi-drug resistant bacteria~   "
101228|NCT01732237|"~     The purpose of the study is to investigate the pharmacokinetics (what the body does to the~     medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single~     oral dose of 100 micrograms under fasted conditions in healthy male participants.~   "
101229|NCT01732224|"~     The relevant data will be prospectively collected included patient demographics, clinical,~     all laboratory variables including virological tests, genotyping by direct sequencing,~     abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy~     (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not~     evident whether the underlying liver disease was chronic based on clinical, biochemical,~     radiological investigations, and upper GI endoscopy. Severity of the liver disease will be~     assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD)~     score.~   "
101230|NCT01732211|"~     The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in~     subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care~     therapies.~   "
101231|NCT01732081|"~     It is estimated that 350-400 million people worldwide are chronically infected with~     hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of~     chronic HBV infection and are responsible of about 500,000 deaths each year. Although some~     predictive factors of the outcome of chronic HBV infection were reported, it remains needed~     to more precisely determine the factors which are associated with the outcome in~     non-selected patients. Indeed, these factors should help to identify patients who are likely~     to have a better or worse evolution of their chronic HBV infection over time and thus, to~     adapt their clinical management and monitoring.Therefore, our purpose is to constitute a~     real-life cohort of non-selected patients to create a database of epidemiological,~     clinical, biological, virological and therapeutic parameters, in order to determine factors~     associated with the outcome of chronic HBV infection.~   "
101232|NCT01732068|"~     The purpose of the present study is to examine the level of ovarian response and the~     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with~     150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.~   "
101242|NCT01731938|"~     This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in~     patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be~     present. The purpose of this study is to demonstrate that FS Grifols is not inferior to~     commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time~     to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for~     study teams to become familiar with the application of FS Grifols and a Primary Part (II) to~     assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be~     randomized in a 1:1 ratio to either FS Grifols or Surgicel.~   "
101243|NCT01731925|"~     Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of~     subjects with neuroendocrine tumors.~   "
101244|NCT01731912|"~     This pilot clinical trial studies how well degarelix acetate before and during radiation~     therapy works in treating patients with prostate cancer. Androgens can cause the growth of~     prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens~     made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Giving degarelix acetate together with radiation therapy may work better in treating~     prostate cancer.~   "
101233|NCT01732055|"~     Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy~     (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for~     Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH)~     Perinatal Psychiatry Program.~      Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a~     depressive episode, and their partners.~      Methods: Women and their identified partners will complete a diagnostic interview, complete~     measures of depressive symptom severity at baseline, and be randomized to treatment with~     PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the~     UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one~     of a number of antidepressant medications, tailored to the individual, although some women~     may opt against medication altogether and still be eligible to enroll). Women randomized to~     PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week~     period, along with one refresher session at or around 6 weeks postpartum. Women and partners~     will be assessed for change in depressive symptoms and relationship satisfaction during~     pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.~      Hypothesis: The investigators anticipate notable improvement in both groups similar in~     magnitude, however it is hypothesized that couples participating in PA-IPT will have higher~     relationship satisfaction post-treatment (controlling for baseline satisfaction) than those~     receiving TAU.~   "
101234|NCT01732042|"~     Determinate the standard values of the retinal venous pressure in a cohort of healthy~     subjects.~   "
101235|NCT01732029|"~     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation~     (SpO2). In developing countries, pulse oximeters are rare because of expense and electricity~     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone~     (which are widely available in developing countries) to compute and analyze information from~     a pulse oximeter sensor. To further reduce costs, we have developed an oximeter sensor~     (AudioOx) that plugs into the audio jack of a standard cell phone. This study aims to~     calibrate the AudioOx by exposing 30 healthy adult volunteers to various altitudes in UBC's~     hypoxia chamber.~   "
101236|NCT01732016|"~     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation~     (SpO2). In developing countries, pulse oximeters are rare because of expense and electricity~     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone~     (widely available in developing countries) to compute and analyze information from a pulse~     oximeter sensor. To further reduce costs, we use the integrated flashlight of a cell phone's~     camera to extract SpO2 (Camera Oximeter), eliminating the need for external hardware. This~     study aims to calibrate the Camera Oximeter by exposing 30 healthy adult volunteers to~     various altitudes in UBC's hypoxia chamber.~   "
101237|NCT01732003|"~     The biological membranes that surround a cell and its organelles are vital to the overall~     function of the cell. Fatty acids are the main structural component of membranes, and the~     presence of specific fatty acids can alter a membrane's characteristics, which subsequently~     alters function. Two fatty acids that are of particular interest to researchers are~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These omega-3 fatty acids have~     unique unsaturated structures, and their incorporation into biological membranes appear to~     elicit potent physiological effects. The body is unable to intrinsically synthesize these~     important fatty acids, so they must be obtained from the diet or through supplementation.~      Compared to research investigating other body tissues, the effect of EPA and DHA on skeletal~     muscle membranes and cellular function has received little attention. Of the studies done,~     EPA and DHA supplementation consistently results in increased EPA, DHA, and total omega-3~     fatty acid content in the skeletal muscle membranes of rodents. One study has also~     demonstrated this effect in humans. These studies, however, have been limited to whole~     muscle measurements, yet cells contain numerous subcellular membranes with diverse~     functions. Two membranes of key importance to the metabolic function of a skeletal muscle~     cell are the membrane that surrounds the cell (plasma membrane), and the membrane that~     surrounds the mitochondria.~      The plasma and mitochondrial membranes are responsible for taking up nutrients and~     converting them into useable energy for the muscle. Recent findings suggest that~     physiological changes in these processes may occur following EPA and DHA supplementation. At~     rest and during exercise, there is potential for a shift in substrate selection that favors~     fat utilization following EPA and DHA supplementation. Several membrane proteins are~     responsible for transporting fat into the cell and mitochondria. The presence of EPA and DHA~     within membranes has the potential to affect the membrane integration and function of~     proteins. The investigators aim to determine whether fat utilization increases following EPA~     and DHA supplementation, and if there is a concurrent change in the concentrations of fat~     transport proteins within plasma and mitochondrial membranes. Supplementation with EPA and~     DHA may also affect oxygen consumption, an important process in energy production that is~     regulated by mitochondrial membrane proteins. Evidence from human and rodent studies shows a~     decrease in whole body oxygen consumption following supplementation. The investigators aim~     to examine these changes directly by measuring mitochondrial respiration following EPA and~     DHA supplementation.~      Therefore, the primary purpose of this study is to examine how plasma and mitochondrial~     membrane fatty acid composition change individually in response to EPA and DHA~     supplementation in humans. The secondary purpose of this study is to examine functional~     metabolic changes that occur in skeletal muscle in response to EPA and DHA supplementation,~     and to investigate correlational relationships between these changes and any compositional~     alterations in plasma and mitochondrial membranes. The investigators hypothesize that~     supplementation with EPA and DHA will alter fuel selection at rest and during exercise, and~     this will correspond to an increase in the concentration of membrane fatty acid transport~     proteins, and that these changes will correlate to an increase in the EPA, DHA, and total~     omega-3 content of plasma and mitochondrial membranes.~   "
101238|NCT01731990|"~     This study is designed to assess the safety, tolerability and efficacy of ACZ885 on the leg~     artery structure and physical activity in patients with atherosclerotic peripheral artery~     disease and leg pain from walking.~   "
101239|NCT01731977|"~     The onset of Psychosis forces family members to bear a heavy burden of care. The mental~     well-being of the family is so complicated that it is important to relieve their~     psychological stresses. Although family psychoeducation has been established as an~     evidence-based practice especially for schizophrenia, few studies have primarily intended to~     reduce the distress of the family due to the burden of care. MacFarlane's multifamily~     psychoeducation is one of the representative models of a group setting, which is based on~     the behavioral therapeutic approach. In such psychological interventions, it has been~     emphasized to focus on the strengths that a person originally has for coping with~     difficulties. The intervention of mainly drawing the strengths from the family might empower~     them and lighten their psychological burden.~      The first 2-5 years from the onset of psychosis is regarded as the critical period to~     improve the prognosis, so the intervention including more recent-onset psychotic patients~     might be of use. With regard to a setting of the psychoeducational intervention, a~     homogeneous group one can make the program better fitted for their problems. The present~     study aims to examine if the strength-based family psychoeducaiton for youth psychosis in a~     group setting in addition to the treatment as usual would be more effective for alleviating~     the psychological distresses of the family than the treatment as usual alone. Moreover, its~     impact on the family of recent-onset psychosis is explored as the subgroup.~   "
101240|NCT01731964|"~     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in~     patients with bilateral moderate to profound central vision impairment due to end-stage~     age-related macular degeneration.~   "
101241|NCT01731951|"~     This pilot clinical trial studies how well imetelstat sodium works in treating patients with~     primary or secondary myelofibrosis and other myeloid malignancies. Imetelstat sodium may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth~   "
101246|NCT01731886|"~     The study is being done to compare the combination of lenalidomide and dexamethasone~     followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and~     dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison~     will include how the subjects respond to each study treatment combination, and what side~     effects are caused by each combination.~   "
101247|NCT01731873|"~     The purpose of this research study is to identify factors and genes (the nucleic acid~     material that determines the makeup of the human body) that may be associated with how~     patients respond to pain medication, like morphine, which are called opioids. Though these~     pain medicines are used everyday, some patients have bad reactions from their use, like~     breathing problems, sedation, etc. It is not possible to completely predict which pain~     medicine is 'right' for a child. The investigators want to study factors that may be~     associated with pain sensitivity, pain medicine requirements after surgery and their~     side-effects. The investigators expect that the information obtained in this research study~     will help us to develop effective, safer, and tailored treatment options in the future.~   "
101248|NCT01731860|"~     A standard PET/CT scanner is comprised of two different machines: An X-ray computed~     tomography scanner (CT), which gives information about your anatomy, and a Positron Emission~     Tomography scanner (PET) that provides information about how the body functions. Both of~     these work together to make the final images for doctors to review. As part of this research~     study the investigators would like to test a new scanner technology by evaluating the~     quality of the images obtained using this new PET system.~      The scanner the investigators would use is able to do both types of examination, the~     standard PET/CT and the additional research PET. The new PET system adds a second scanner~     ring to the standard PET/CT. This allows the patient to stay on the same imaging table for~     both studies. Being in this study does not change how the standard PET/CT will be done.~   "
101249|NCT01731847|"~     The investigators aimed to evaluate effects of combined NMES, FEES and traditional~     swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.~   "
101250|NCT01731834|"~     There may be pain and / or stress with vibrocompression. There may be pain and / or stress~     with the aspiration of secretions.~   "
101251|NCT01731821|"~     Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study~     is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named nonstented~     stump-closed pancreaticojejunostomy in pancreatoduodenectomy, which could provide a~     feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.~   "
101252|NCT01731808|"~     The purpose of the study is to evaluate the feasibility and effectiveness of a physician~     directed nurse managed earlier outpatient counselling intervention for patients with~     diabetic foot ulceration.~      For the purpose effectiveness is defined in two ways.1) as a reduction in hospital~     readmissions for complication for foot ulcers such as amputation or increased severity of~     the ulcer and 2) reduction in amputations, readmission rates. Selected covariates~     (self-efficacy,self-management, social support and depression) will be included to estimate~     predictors for readmission and amputation.~   "
101253|NCT01731795|"~     BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the~     acute respiratory distress syndrome (ARDS). Great interest remains in the use of~     corticosteroids for the salvage of patients with severe acute lung injury in the early phase~     of their disease process, a situation that that has not been evaluated in most published~     trials. Dexamethasone has never been evaluated in ARDS in a randomized controlled fashion.~      HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with~     intravenous dexamethasone of patients with established ARDS might change the pulmonary and~     systemic inflammatory response and thereby will increase the number of ventilator-free days~     and will decrease the extremely high overall mortality. Our goal is to examine the effects~     of dexamethasone on length of duration of mechanical ventilation (assessed by number of~     ventilator-free days) and on mortality, in patients admitted into a network of Spanish~     intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.~   "
101254|NCT01731782|"~     Patients experience pain after surgery mostly from their abdominal wounds, even when those~     wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases~     stress response and might improve the outcome of the surgery. Local anesthesia (which is a~     numbing agent given directly at the site of pain via a needle) is given to decrease the pain~     that is felt after surgery and decrease the need for strong pain medications which can have~     negative side effects.~      One promising way to give local pain medication is called the transversus abdominis plane~     or TAP block. This method works by directly blocking the nerves in the abdomen that are the~     cause of the pain patients feel in their incision after surgery. This is done by injecting a~     numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located~     that cause pain.~      In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling~     in a particular nerve.~      Patients will be randomized (like a flip of a coin) to receive either a normal saline~     injection or the bupivacaine injection.~      The purpose of this study will be to prove the effectiveness of local anesthetic given via a~     TAP block in improving postoperative pain, decreasing the use of pain medications,~     decreasing postoperative nausea and vomiting and improve surgical outcomes such as hospital~     length of stay in laparoscopic colorectal surgery.~   "
101255|NCT01731769|"~     Axillary dissection is the standard treatment for breast cancer patients with positive~     nodes. However, seroma formation after axillary dissection remains the most common early~     complication to breast cancer surgery. It can delay the initiation of adjuvant therapy,~     predispose to wound infection, delay wound healing and has also been linked to arm~     lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is~     effective in complex wound failures following axillary dissection and groin dissection, we~     use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed~     to evaluate the efficacy, safety and economics benefits of early VAC application on~     postoperative complications and wound healing after extensive axillary dissection in~     comparison to conventional suction drain.~   "
101256|NCT01731756|"~     Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,~     double-blind, placebo-control trial~   "
101257|NCT01731743|"~     The purpose of the study is to evaluate the far, intermediate and near visual acuities with~     a trifocal IOL.~   "
101259|NCT01731717|"~     The main aim of the project is the implementation and evaluation of a stepped care model~     (SCM) for patients with depression with 6 treatment options of varying intensity and~     setting, including innovative technologies (e-mental health, telephone-based psychotherapy).~     Within this complex intervention, patients are treated by a multiprofessional network of~     health care providers in Hamburg, Germany. The study compares the SCM condition~     (intervention group) to a control group receiving treatment as usual (cluster randomization~     on the level of participating general practitioners). It is expected that the SCM condition~     will show better results regarding reduction of mental symptoms, improvement of quality of~     life, more efficient access to care and better cost-benefit ratio.~   "
101260|NCT01731704|"~     This is randomized study of neurocognitive outcomes in patients with five or more brain~     metastases treated with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK)~     system, or whole-brain radiation therapy (WBRT). The primary aim of this study is to compare~     the change in neurocognitive function outcome between baseline and 6 months in WBRT versus~     SRS treatment groups.~   "
101261|NCT01731691|"~     Our primary objective is to further characterize the mechanism by which alpha-1PI regulates~     CD4 counts.~      HIV-1 infected patients will be initiated on PROLASTIN®-C (Alpha-1 Proteinase Inhibitor~     [Human], Grifols Biotherapeutics Inc.) or placebo. Uninfected volunteers will be untreated~     and will be monitored for comparison.~   "
101262|NCT01731678|"~     Major depression (or MDD) in adolescents is a major public health problem. MDD affects~     approximately 15% of adolescents; it is associated with impairment in social, family, and~     academic functioning, and it is a major risk factor for suicide - a leading cause of death~     in adolescents . Unfortunately, there is a paucity of treatment options for this age group.~     Selective serotonin reuptake inhibitors (SSRIs) are the only class of medications approved~     for treating MDD in adolescents, but rates of remission following treatment with SSRIs are~     only 30 to 45 percent. Cognitive behavior therapy is associated with similar remission rates~     and access is limited. Most adolescents will require more than one therapeutic intervention~     in order to achieve full symptom control. Collectively, there is overwhelming evidence that~     additional treatment options are urgently needed to improve outcomes for teens with MDD. One~     novel treatment for adolescent MDD is repetitive transcranial magnetic stimulation (rTMS).~     Studies in children have been limited (a total of 23 cases). This is surprising given the~     evidence suggesting younger adult subjects with MDD respond better to rTMS (56% response~     rate) than older subjects. This limited experience with rTMS for adolescent MDD represents a~     substantial gap in the knowledge, recently recognized in publications calling for further~     study of rTMS in adolescent depression. Most importantly, the mechanism of action of rTMS in~     adolescent MDD is not well understood. The objective of this application is to develop an~     understanding of the brain alterations associated with the positive clinical changes that~     occur with rTMS in adolescent MDD. Such knowledge will provide the basis for pursuing rTMS~     for adolescent MDD as a rational therapeutic technique.~      Specific Aim: To compare the effect of rTMS on DLPFC glutamate concentration in adolescent~     MDD. The investigators hypothesize an increase (normalization to controls) in DLPFC~     glutamate after three weeks of rTMS. Furthermore, the change in glutamate concentration will~     correlate with a change in MDD symptoms.~   "
101263|NCT01731665|"~     The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics~     and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul,~     Korea.~   "
101264|NCT01731652|"~     This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients~     with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.~   "
101265|NCT01731639|"~     A new technique based on the motile sperm organelle morphology examination (MSOME) at a~     magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both~     shape and chromatin content, which is the most important sperm organelle in influencing~     intracytoplasmic sperm injection (ICSI) outcomes.~   "
101266|NCT01731613|"~     This clinical trial will compare how the individualized and fortified human milk feeding~     will help a premature infant grow.~   "
101267|NCT01731600|"~     This trial is conducted globally. The aim of the trial is to investigate safety, efficacy~     and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003~     (N8-GP) in children with severe haemophilia A who have undergone treatment with previous~     factor VIII (FVIII) products.~   "
101268|NCT01731587|"~     Phase Ib study investigating whether liposome BLP25 mucin-1 (MUC1) peptide-specific~     immunotherapy (L-BLP25) administered as weekly subcutaneous doses over 8 weeks following a~     single dose of intravenous cyclophosphamide (CPA) induces a reproducible cytokine pattern~     measured in the serum of unresected Stage III non-small cell lung cancer (NSCLC) subjects~     after first-line chemo-radiation therapy.~   "
101269|NCT01731574|"~     This trial will investigate the potential drug-drug interaction between dapivirine vaginal~     Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of~     co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,~     HIV-negative women.~   "
101270|NCT01731561|"~     The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA~     and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis:~     prospective, multicenter, controlled, randomized comparative study of two rituximab~     regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.~   "
101271|NCT01731548|"~     We hypothesized that the local control for both arms were not statistically significant,~     when irradiation to the post-induction chemotherapy tumor volume is compared with~     irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation~     will be omitted for both arms.~   "
101272|NCT01731535|"~     Dose and duration of bisphosphonate therapy will increase the likelihood that patients~     experience delayed healing of non-union fractures.~   "
101273|NCT01731522|"~     The purpose of this study is to examine the influence of two Eating Frequency prescriptions,~     meal (energy intake occurring during three meals per day) and grazing (energy intake~     occurring every two to three hours per day), on consumption during an ad libitum meal~     consumed at the end of the day, overall daily energy intake, and ratio of energy intake to~     energy expenditure. It is hypothesized that the grazing condition will produce lower~     consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio~     of energy intake to energy expenditure than the meal condition.~   "
101290|NCT01731301|"~     1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD~          undergoing hemodialysis.~        2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease~          (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with~          peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.~        3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis~          can achieve rapid virologic response (RVR), extended virologic response (eRVR) and~          sustained virologic response (SVR) when treated with peginterferon alfa-2b, the~          maximally tolerated dose of ribavirin and boceprevir.~   "
101274|NCT01731509|"~     Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in~     those cases with severe forms where there are extremely reduced lung volumes, liver~     herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal~     occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal~     pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal~     pulmonary response followed FETO can be used to predict outcome and is dependent on the size~     of the fetal lung prior to the procedure.~      We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe~     form of CDH will have a better fetal pulmonary response and higher chance of surviving.~   "
101275|NCT01731496|"~     The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls~     and boys starting at age 11, although it can be offered as young as 9 years of age. This is~     a 3-dose series and many adolescents do not complete it after getting the first dose. This~     study will study how effective it will be to send reminders to parents to schedule an~     appointment when their child is due for the next dose of HPV. Parents can chose whether they~     would like a phone call or text message reminder. This study will determine if the reminders~     work, and if one method is better than another (phone message vs. text message).~   "
101276|NCT01731483|"~     the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP~     activation in invasive staphylococcal and streptococcal infections.~   "
101277|NCT01731470|"~     Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic~     disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that~     dramatically affects quality of life.~      Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats)~     have demonstrated normalization of urinary frequency indicating that LP may be a potent~     protectant of the bladder mucosa against inflammation and irritation. Intravesical LP has so~     far demonstrated an excellent safety profile and minimal toxicity at concentrations of 2~     mg/ml. Thus, we hypothesize that intravesical instillation of LP may form a molecular film~     on bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally~     invasive treatment option to alleviating symptoms.~   "
101278|NCT01731457|"~     The aims of this study are:~        1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria~          deceased donor before transplantation~        2. assessment of efficacy of kidney ischemia injury decreasing~        3. assessment of influence of kidney ischemia injury decreasing on its function after~          transplantation For the purpose of this research one hundred kidney will be retrieved~          from deceased donors (standard and expanded criteria deceased donors) for~          transplantation. All kidneys before transplantation will be stored in machine perfusion~          in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single~          kidney in self-contained perfusion system.~      For the kidney allograft assessment will be used measurements performed during machine~     perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and~     ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.~      For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor~     (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein~     (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1),~     neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.~      Every time from pair of retrieved kidneys each kidney will be randomise for one of the~     group:~        -  group 1) - 50 kidneys - examined group - cured with etanercept (ENBREL) in the first~          hour of perfusion by adding drug to perfusion fluid,~        -  group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers~          will be measured in perfusion fluid by kidney two times (in the first and fourth hour~          of perfusion) for assessment of efficacy kidney ischemia injury decreasing.~      Results of measurements of kidney ischemia injury before transplantation, parameters during~     machine perfusion in hypothermia and donor parameters will be correlated with kidney~     allograft function post transplantation.~      Immediate, delayed and slow graft function, primary non-function, kidney function assessed~     by creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6~     and 12 months post transplantation and kidney graft survival 6 and 12 months post~     transplantation will be analysed.~   "
101279|NCT01731444|"~     The standard of care for treatment of burn injury is to inject a solution of epinephrine~     under the skin of the injured site in order to reduce blood loss during skin grafting. This~     solution of epinephrine has been shown to have effects on the body outside the donor site.~     Some people have increases in heart rate and blood pressure. We will study the effect of a~     phenylephrine solution in place of an epinephrine solution to control blood loss. We think~     that phenylephrine will help decrease blood loss and not change blood pressure or heart~     rate.~      The injured area will be injected under the skin and a skin graft will be taken in the same~     way as we usually do. The only change will be the use of phenylephrine in the solution~     instead of epinephrine.~      Our goal is to find whether or not phenylephrine or epinephrine solution results in a~     reduction of blood loss without affecting the rest of the body.~   "
101280|NCT01731431|"~     This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the~     treatment of gestational diabetes.~   "
101281|NCT01731418|"~     The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is~     an effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder~     (PTSD) and depression and for the improvement of daily functioning in Iranian women who have~     experienced intimate partner violence (IPV). In addition, the study seeks to investigate~     whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within~     their marriage.~   "
101282|NCT01731405|"~     The purpose of this study is to determine the potential efficacy of three revised Medication~     Guide layouts to increase consumers' comprehension~   "
101283|NCT01731392|"~     To investigate the effect of milk-based formulas on infections and immune functions in~     healthy children.~   "
101284|NCT01731379|"~     Investigation of application possibilities of optical spectroscopy within the field of~     surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the~     possibility to specifically differentiate between different (human) tissues. The hypothesis~     is that incorporation of this technique into existing medical devices (e.g. medical blade)~     would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during~     surgery can lead to decreased postoperative morbidity rates.~   "
101285|NCT01731366|"~     Objective: To identify how specific changes of the whole grain content in the diet affect~     the host-gut microbiome interactions with implications for metabolic health .~      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting~     of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60~     participants will be included.~      Intervention: low vs. high whole grain intake.~   "
101286|NCT01731353|"~     The objective of this registry is to broaden the knowledge on epidemiology, diagnostic~     procedures and clinical course of emerging invasive fungal infections.~   "
101287|NCT01731340|"~     The overarching aim of this randomized clinical trial is to estimate the effect of dietary~     intake of calcium as compared to supplemental calcium on the vascular system and markers of~     vascular and bone health in postmenopausal women.~   "
101291|NCT01731288|"~     The main purpose of this study is to assess conception, pregnancy, childbirth, and pain~     experiences among women who have been diagnosed with vulvodynia. Specifically, this study~     aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates~     of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3)~     potential difficulties experienced while attempting to become pregnant and during~     pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to~     manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.~      Very little research has examined pregnancy/childbirth experiences among women with~     vulvodynia, or the natural history of vulvodynia. As such this is a preliminary~     investigation that will provide descriptive information regarding many of the proposed~     research questions. Based on the clinical experience of the investigators, it is expected~     that women with vulvodynia will report lower rates of pregnancy and higher levels of fear~     about pregnancy and childbirth in comparison to women without such pain. It is also expected~     that women with vulvodynia will report more difficulties becoming pregnant as compared to~     women without such pain, and that women with vulvodynia will report more elective nonvaginal~     births in comparison to vaginal births.~   "
101292|NCT01731275|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single~     ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.~   "
101293|NCT01731262|"~     Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not~     been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial~     angiogenesis is the most important cause of RA synovitis and joint destruction. Our study~     was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of~     fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.~   "
101294|NCT01731249|"~     The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of~     300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior~     to the birch pollen season and continuing over the birch pollen season compared with placebo~     for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.~   "
101295|NCT01731236|"~     The principal goal for the study is to examine the role gut flora plays in modulating~     metabolism of dietary carnitine and choline in humans.~   "
101296|NCT01731223|"~     The aim of this study is to analyze if group treatment is effective to treat insomnia in~     primary healthcare.~   "
101297|NCT01731210|"~     The LENEA study is an international, prospective, open label, non-randomized multicenter~     clinical research study designed to assess the safety and effectiveness of the NANO LV lead~     system.~   "
101298|NCT01731197|"~     Proteins are known to be more satiating than the other macronutrients; however, the type and~     amount of protein needed to induce a significant effect on satiety (fullness between meals)~     is sometimes difficult to determine. In this study, 2 differentially processed isolated soy~     proteins will be tested for satiety using subjective visual analogue scales. The amount of~     food consumed following intake of the isolated soy proteins will be measured 3 hours after~     consuming the proteins. The hypothesis is that differentially processed isolated soy~     proteins will show unique satiety responses.~   "
101299|NCT01731184|"~     Administration of midazolam with morphine in patients with severe acute pain is a routine~     practice in the management of pre- and post-operative patients but has not been evaluated in~     pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam~     in the pre-hospital management of traumatic patients with severe acute pain.~      In a multicenter prospective randomized double-blind placebo-controlled trial, the~     investigators would like to compare the analgesic effect and safety of the intravenous~     morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and~     placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a~     validated numeric rating scale (NRS).~      The primary outcome will be the proportion of patients with a pain score less than or equal~     to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the~     treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose~     required until obtaining a pain score less than or equal to 3.~   "
101300|NCT01731171|"~     The purpose of this study is to determine if taking a probiotic supplement versus a placebo~     will lower rates of relapse and improve the clinical course among participants who have been~     hospitalized for mania. Relapse and clinical course are measured by time to~     re-hospitalizations, new mood episodes, and changes in mood-related symptoms.~   "
101301|NCT01731158|"~     This will be a prospective, open label, randomized multicenter phase-II study to evaluate~     progression free survival (PFS) in 2nd line treatment in patients with locally advanced or~     metastatic clear-cell renal cell cancer (cc-RCC) receiving everolimus (arm A) in comparison~     to a tyrosine-kinase inhibitor (TKI) (arm B). Following 2nd line treatment, patients will be~     switched to a TKI in arm A and everolimus in arm B. All patients will receive bevacizumab as~     standardized first-line treatment.~      Another key element of the study is the analysis of predictive biomarkers, which will be~     performed in serum and tumor tissue, respectively. Serum samples will be collected at~     prespecified timepoints throughout the study and analysed by SELDI-TOF-MS and DIGE.~     Candidate proteins are thought to predict therapeutic outcome and candidates are subject for~     target validation by Western Blot or ELISA. In addition, formalin-fixed paraffin-embedded~     (FFPE) tumor tissue will be collected prospectively and analysed for micro RNA (miRNA).~     Candidate miRNAs that predict therapeutic outcome will be validated by quantitative RT-PCR.~     Furthermore, circulating tumor cells (CTCs) will be generated from blood drawings during~     routine visits. The primary objective is to correlate the marker profile defined from the~     FFPE tissue with the profile obtained from CTCs in order to validate expression based~     markers ant their change during different treatment lines.~   "
101302|NCT01731145|"~     The purpose of this study is to record and measure tremor using portable six-axis (tri-axial~     accelerometer and tri-axial gyroscope) motion sensing system.~   "
101303|NCT01731132|"~     Knowledge about the impact on quality of life of women initiating IUD in the Spanish~     population at baseline and after 12 months of use.~   "
101358|NCT01730404|"~     Phase IIa study in COPD patients aimed to evaluate the safety, tolerability~     ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in~     blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor)~     after 28-days of daily inhaled dosing.~   "
101304|NCT01731119|"~     The overarching purpose of this pilot study is to collect preliminary data regarding the~     variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic~     naive children and adolescents in order to inform decisions about including a lurasidone arm~     in a future large scale trial of different approaches to minimize antipsychotic associated~     weight gain in the pediatric population. In adults, lurasidone appears to cause minimal~     weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,~     or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic~     exposure.~   "
101305|NCT01731106|"~     Brief Summary Cerebral Autoregulation is a well known physiological response to blood~     pressure changes to maintain the cerebral perfusion. The critically ill patients are~     submitted to different situations that can impair the cerebral autoregulation as sepsis,~     sedation drugs and mechanical ventilation.~      The delirium on ICU has been described as a bad prognosis factor, increasing the mortality~     and length of stay. The physiopathology of delirium has been related to cerebral perfusion.~     The delirium has been related to long term cognitive impairment.~      Material and Methods:~      This is a physiological prospective study that will be done in a 14 bed medical-surgical~     ICU. The investigators will enroll 100 ventilated patients, septic and non-septic. The~     investigators will measure cerebral autoregulation every 48-72 hours from admission on ICU.~     Neurological biomarkers (Neurological Specific Enolase, S100 beta and Vascular Endothelial~     Growing Factor) will be done at inclusion, 72 hours and 7 days. Clinical data, delirium~     presence, analytic data and ventilatory parameters will be registered every day.~      At hospital discharge, a psychologist will do a cognitive evaluation using specific tests.~     The cognitive evaluation will be repeated at 3, 6 and 12 months.~      Anticipate results:~      Some items like mechanical ventilation, sepsis and sedation can impair cerebral~     autoregulation. The impairment of cerebral autoregulation is related to delirium in ICU and~     long cognitive impairment.~   "
101306|NCT01731093|"~     The purpose of this study is to determine the safety, bioavailability, and effectiveness of~     an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in~     the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium~     is a very powerful antioxidant that could prove useful in reducing the harmful effects of~     oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent~     work has demonstrated that the specific type of selenium compound greatly influences it's~     ability to enhance brain health and prevent Alzheimer changes in mouse models of this~     disease.~      This study will enroll 24 participants and will allow us to test the hypotheses that~     yeast-selenium supplementation is safe in the elderly, and that our specific formulation~     reduces brain oxidative stress.~   "
101307|NCT01731080|"~     Quantification and preferential sites of arterial wall calcification within the coronary and~     lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type~     2 diabetics and Chronic Kidney disease.~   "
101308|NCT01731067|"~     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes~     and transporters in vivo. It consists of the administration of probe substances metabolised~     by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by~     the determination of a metabolic ratio or the evaluation of the plasmatic or urinary~     concentrations of the probe substances. The administration of a cocktail containing several~     probe substances allows the simultaneous evaluation of the activity of several cytochromes~     and P-gp in a single test.~      The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs~     for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling~     and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion,~     flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous~     phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.~      The modulation of the activity of cytochromes or P-gp will be evaluated by the~     administration of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin)~     of the metabolic pathways or the P-gp mediated transport.~   "
101309|NCT01731054|"~     The primary objectives of the study are as follows: To develop and optimize a renal~     functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted~     Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial~     Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal~     functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus~     nephritis (LN) participants.~      The secondary objectives of this study are as follows: Explore whether renal functional MRI~     techniques discriminate between renal inflammatory activity and damage in lupus nephritis~     (LN); To examine whether renal functional MRI measurements correlate with laboratory~     features of renal involvement and renal function in participants with lupus nephritis (LN).~   "
101310|NCT01731041|"~     Platelets are parts of your blood that stick together to help form a clot. The stickier your~     platelets are, the greater your chance of having a heart attack. A clot in the wrong place~     can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking~     together and it helps people from having a heart attack. The American College of Cardiology~     has recommended a combination of aspirin and Brilinta as one of the best treatments for the~     prevention of heart attacks, and death in patients who have had a heart attack or coronary~     stents. However, it is unknown if Brilinta may improve its work to keep platelets from~     sticking together giving a loading dose in patients already treated with Brilinta. A loading~     dose is a one-time increased dose of the same drug. The purpose of this study is to~     demonstrate whether the platelets of patients treated with Brilinta become less sticky when~     Brilinta is re-loaded.~   "
101311|NCT01731028|"~     The purpose of this study is to investigate the long-term treatment with Zomacton® for~     pituitary short stature in children with insufficient growth hormone production and/or short~     stature caused by Turner's syndrome.~   "
101312|NCT01731015|"~     The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as~     an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to~     allow an effect size estimate to power future studies.~   "
101313|NCT01731002|"~     Double-masked, randomized, multi-center, dose-response, active-controlled~     parallel-comparison of Netarsudil (AR-13324) to latanoprost~   "
111349|NCT01598805|"~     Now, after a cluster randomized controlled trial, eAlerts providing evidence-based~     guidelines on venous thromboembolism prophylaxis will be rolled out and evaluated~     hospital-widely.~   "
101314|NCT01730989|"~     Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night~     sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality~     of life. The gradual decline of oestrogen from peri-menopause results in altered function of~     many neurotransmitters, such as dopamine, melatonin and neuropeptides including~     beta-endorphins, which modulate the function of the hypothalamus and are involved in body~     thermoregulation.~      In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2~     receptors is effective in relieving hot flushes and in reducing the accompanying~     psychological symptoms.~      The use of hormone replacement therapy, which is generally prescribed in the case of~     moderate or severe symptoms, is limited due to real contraindications or simply the woman's~     refusal to take the therapy, despite the presence of symptoms requiring its use.~      A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,~     the absorption of which is increased by the presence of Lactobacillus sporogenes, and~     Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at~     reducing vasomotor symptoms.~      To potentiate the effect of E on the most frequent symptoms in menopause, it was considered~     rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste~     tree, acting on both hot flushes and psychological symptoms and a new food supplement was~     developed: Estromineral Serena Plus (ESP).~      Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste~     tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.~   "
101315|NCT01730976|"~     We will study whether taking vitamin D improves asthma control and spirometric values in~     elderly asthmatics.~   "
101316|NCT01730963|"~     This multi-reader multi-case study was designed to evaluate the performance of SureCALL®~     Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).~   "
101317|NCT01730950|"~     This randomized phase II trial studies how well bevacizumab with or without radiation~     therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such~     as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It~     is not yet know whether bevacizumab is more effective with or without radiation therapy in~     treating patients with recurrent glioblastoma~   "
101318|NCT01730937|"~     This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation~     therapy to see how well they work compared to sorafenib tosylate alone in treating patients~     with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send~     the radiation dose directly to the tumor and cause less damage to normal tissue. Giving~     sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor~     cells.~   "
101319|NCT01730924|"~     The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation~     is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation~     catheter to deliver targeted burns on the inner surface of the heart. The aim of this~     approach is to cause electrical isolation of the pulmonary veins. The purpose of this study~     is to evaluate whether the information which can be derived from the latest catheter~     technologies - on the degree of contact force between the catheter and the heart - affects~     the time to perform the procedure, or the outcomes as a result of it. Patients undergoing~     pulmonary vein isolation will be randomised to having their procedure performed with the~     contact force information available to the operator, or not available. The time taken to~     achieve pulmonary vein isolation is the primary end-point of the study.~   "
101320|NCT01730911|"~     Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of~     women in the US report using them. Women must often wait for their menses to start, or for~     results of screening for sexually transmitted infections (STIs), before their doctors will~     place IUDs for them. This is not the case with other birth control methods. Researchers know~     that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on~     the same day of a doctor's visit. In the investigators clinical practice, the investigators~     often place IUDs on the same day of a woman's visit, but outcomes have not been formally~     assessed.~      Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A~     and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know~     if women who have IUDs placed at any time during their menstrual cycle have different~     experiences regarding the following, compared to those who have IUDS placed during the first~     7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming~     pregnant more often during that first cycle (window pregnancy).~      Women who come to their provider seeking an IUD for birth control will be asked to~     participate in this study. The investigators will ask them to keep track of their bleeding~     and cramping for three subsequent months to see if patterns differ according to the day in~     their menstrual cycle that the device was inserted. They will be randomly assigned either to~     record this information on paper, or to send in the information by responding to daily text~     messages.~      The investigators want to know if women who have an IUD placed at any time during the~     menstrual cycle have different outcomes compared to those who have IUDs placed during the~     first 7 days of their cycle. If the investigators have this information, the investigators~     can make recommendations to physicians, help counsel patients, and potentially expand access~     to IUDs.~   "
101321|NCT01730898|"~     This study will evaluate the absorption of lutein when consumed in different oil blends.~   "
101322|NCT01730885|"~     Due to continuing technological progress and better understanding of the needs for glucose~     monitoring, the performance requirements of blood glucose meters, primarily regarding their~     accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion~     was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters~     in the point-of-care testing setting by asking for fulfilment of higher requirements.~   "
101323|NCT01730872|"~     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival~     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to~     treatment with a proven ocular anti-inflammatory medication,~      Prednisolone, assessed by the following measures:~      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival~     redness~   "
101324|NCT01730859|"~     Both taping and balance exercises have effects on dynamic balance, so this study compared~     ankle taping and balance exercise on postural stability indices in healthy women. we~     hypothesized that both balance exercise and taping would increase stability indices but the~     effects of balance exercise was more greater than taping.~   "
101325|NCT01730846|"~     The purpose of this study is to examine whether doxazosin will attenuate the ability of~     stress to precipitate smoking lapse behavior in treatment seeking daily smokers.~     Participants will participate in a smoking cessation attempt after the laboratory sessions.~   "
101326|NCT01730833|"~     This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel~     albumin-stabilized nanoparticle formulation work in treating patients with human epidermal~     growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies,~     such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel~     albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or~     stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel~     albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.~   "
101327|NCT01730820|"~     The perioperative hemodynamic management aims to ensure organ perfusion pressure and an~     oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic~     agonist widely used during anesthesia for arterial pressure control.~      Several questions on phenylephrine global and regional hemodynamics effects remain~     unresolved.~      The investigators assume that Phenylephrine may decrease cardiac output by increasing the~     afterload, while most likely could also make an increase or a stability of cardiac output by~     action on the venous return. The investigators propose an observational study assessing the~     influence of preload dependence, defined by the values of pulse pressure variation, on the~     effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.~      The aim of the investigators work is to improve the understanding of phenylephrine action, a~     daily use therapeutic action, to improve the patients care.~   "
101328|NCT01730794|"~     The purpose of this study is to compare a specific mode of artificial ventilation (help from~     a breathing machine) with other modes. This specific mode is called Neurally Adjusted~     Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from~     the diaphragm (breathing muscle) to help patients breathe. The investigators believe that~     using these signals, NAVA can determine the exact timing for patients' spontaneous breathing~     effort and delivers the artificial breath at the same time (in synchrony) with their own~     breath. Other modes (breathing methods) may cause asynchrony between the patient and the~     ventilator while delivering artificial breaths because of the way they operate. Asyncrony~     between patient and ventilator is a risk factor for increasing the length of artificial~     ventilation and number of related complications. The investigators would like to find out if~     NAVA performs better in establishing synchrony between patient and ventilator and as a~     result decreasing time for artificial ventilation and increasing better outcomes.~   "
101329|NCT01730781|"~     The aim of the present study is to assess the availability of cannabinoid receptors (CB1R)~     in the human brain. CB1R are present in everyone's brain, regardless of whether or not~     someone has used cannabis. The investigators will image brain cannabinoid receptors using~     Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals~     and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3)~     prodrome of psychotic illness and 4) individuals with a family history of alcoholism, using~     the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the~     number and distribution of CB1R in these conditions. It is likely that the list of~     conditions will be expanded after the collection of pilot data and as new data on~     cannabinoids receptor function and psychiatric disorders becomes available.~      Those in the cannabis us disorder arm of the study will have a PET scan on at least three~     occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and~     a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4~     weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most~     schizophrenia patients may get scanned just once, a subgroup of patients may get scanned~     more than once. For example to tease out the effects of medications, unmedicated patients~     may get scanned while unmedicated and again after treatment with antipsychotic medications.~     Similarly prodromes may get scanned while in the prodromal stage off medications, on~     medications and after conversion to schizophrenia.~   "
101330|NCT01730768|"~     This is a study in chronic stable Schizophrenia with the purpose to answer the question of~     whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well~     defined chronic stable patient population treated with antipsychotics as standard of care,~     and thus to support the future development of AQW051 for the treatment of cognitive~     impairment associated with Schizophrenia (CIAS).~   "
101331|NCT01730755|"~     Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in~     the VHL gene. Currently, there are no therapies that have proven effective for CP. Recent~     studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the~     activity of JAK2 (Janus kinase 2). In mouse models, inhibition of JAK2 reverses the CP~     phenotype. Therefore, the investigators hypothesize that JAK2 inhibition may have~     significant clinical benefits for CP patients.~   "
101332|NCT01730742|"~     The study proposes to investigate whether sleep deprivation will affect a variety of~     measures, including hormones, immune system functioning, and behaviors related to food~     intake and hunger. It is predicted that sleep deprivation will affect circulating neutrophil~     activity, and do so via affects on DNA methylation. It is also predicted that sleep~     deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is~     predicted that sleep deprivation will increase participants' tendencies to pick larger~     portions of food, and also increase their tendency to purchase foods that are more caloric~     in a mock supermarket scenario.~   "
101333|NCT01730729|"~     Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that~     elevated levels of the hormone prolactin might be associated with an increased risk of~     breast cancer. Cabergoline has been shown to lower prolactin levels in the blood.~      The purpose of this study is to evaluate the effectiveness of cabergoline in treating~     metastatic breast cancer disease in those who test positive for the prolactin receptor.~   "
101334|NCT01730716|"~     The study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe)~     dose of human spinal derived neural stem cell transplantation for the treatment of~     Amyotrophic Lateral Sclerosis (ALS).~   "
101359|NCT01730391|"~     This study aims to provide an estimate of the proportion of suspected cases of bacterial~     meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines~     and Vietnam.~   "
101360|NCT01730378|"~     This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean~     subjects. A second group of subjects will receive FluarixTM vaccine as control.~   "
101335|NCT01730703|"~     The purpose of this interview study is to learn why adults would join a walking program.~     This study involves interviews with persons who are 65 years of age or older. The interview~     takes approximately 25 minutes. A total of 132 people will be enrolled. This study will~     examine the utility or value of various potential features of an incentive-based walking~     program. These data will enable us to monitor and improve upon enrollment of incentive-based~     walking programs.~   "
101336|NCT01730690|"~     Major changes in the epidemiological characteristics of bacterial meningitis have been~     observed as a result of changes in behaviour, human interventions (use of antibiotics,~     prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic~     outbreaks.~      The objective of this study is to identify the determinants of in-hospital mortality of~     bacterial meningitis in adults.~      Hypothesis : the standardized data collection concerning cases of bacterial meningitis in~     adults with telephone follow-up would allow analysis of the determinants of mortality and~     neurosensory sequelae, description of the psychosocial impact and proposal of new treatment~     strategies.~   "
101337|NCT01730677|"~     The investigators address the clinical efficacy of continuing lapatinib treatment combined~     with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared~     with vinorelbine alone in HER2 positive metastatic breast cancer patients.~   "
101338|NCT01730664|"~     Rationale:~      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real~     challenge as failure in response to treatment and serious side-effects are frequently~     encountered. New, more effective drugs with less side effects are therefore urgently needed~     to solve this problem. Although several new drugs against TB are in the pipeline, physicians~     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.~     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.~      Objective:~      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a~     standard dose (2000mg) of ertapenem in TB patients. This clinical trial will provide~     important information on PK of ertapenem in TB patients for future studies. Data can be used~     for limited sampling strategies for ertapenem based on a pharmacokinetic population model~     constructed from the full PK curves of the patients.~      Study design:~      A prospective pharmacokinetic study.~      Study population: 12 TB patients.~      Intervention: Single dose of 2000mg in a 30 minutes intravenous infusion.~      Main study parameters/endpoints:~      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of~     the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most~     likely the best predictive parameters for efficacy of ertapenem treatment and will be~     calculated for a range of M tuberculosis isolates.~   "
101339|NCT01730651|"~     This phase II study of high dose intensity modulated radiation therapy in the cervical~     cancer with metastatic lymphadenopathies at initial diagnosis~   "
101340|NCT01730638|"~     The aim of this study is to optimize pretargeting parameters using pharmacokinetic and~     imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288~     peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at~     least one abnormal lesion~   "
101341|NCT01730625|"~     The development of easily disseminated and efficacious treatment of psychiatric disorder is~     an important goal for translational neuroscience research. To that end, Attention Bias~     Modification Treatment (ABMT), a novel intervention targeting threat-related attention~     biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined~     whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has~     examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the~     treatment of choice for anxiety disorders. Studying this question in youth is particularly~     important given that the onset of most anxiety disorders is during childhood, and early~     interventions may reduce long-term affliction. The current study is the first randomized~     control trial designed to examine the augmenting effects of ABMT on CBT among clinically~     anxious youth.~      The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape~     anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic~     tool. During training, the target location is systematically manipulated to increase the~     proportion of targets appearing at the location opposite the patient's bias. For example, in~     a training protocol intended to reduce threat bias, targets would appear more frequently at~     locations of neutral than threat stimuli.~      Although CBT is an effective treatment for anxiety disorders, combining it with other~     treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two~     interventions targeting different aspects of anxiety and therefore could potentially~     complement one another. While CBT modifies explicit and voluntary attention through verbal~     intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT,~     the integration of the two treatments can have few significant benefits: First, it will~     combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce~     the number of patients who respond poorly to CBT or do not respond at all. Second,~     computer-based training of attention may be more acceptable than traditional in-person~     therapy formats for some children and adolescents and can raise the cooperation in therapy.~     Finally, the CBT setting and the therapist presence can help to insure that ABMT is~     delivered consistently~      The current study was designed to examine the ABMT augmentation effects on CBT for children~     with anxiety disorders. This study is the first randomized control trial in clinically~     anxious youth. Participants were randomly assigned to one of three conditions: 1. Training~     condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT~     alone). We hypothesize that participants in the training condition will show the greatest~     improvement in anxiety symptoms.~   "
101342|NCT01730612|"~     Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68~     Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast~     carcinoma.~      Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to~     standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the~     development of immunization against TF2 or complex TF2-IMP-288;~   "
101343|NCT01730599|"~     This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic~     mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat~     kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between~     genetic mutations in the known genes and their influence on disease manifestation over few~     years of follow up~   "
101344|NCT01730586|"~     The goal of this clinical research study is to learn if abraxane can help to control~     colorectal and/or small bowel cancer. The safety of this drug will also be studied.~      Abraxane is designed to block cancer cells from dividing, which may cause them to die.~   "
101345|NCT01730573|"~     Primary objective of this study is to prospectively compare and evaluate efficacy as well as~     note side effects of the interscalene block and combined suprascapular and axillary nerve~     block for ambulatory arthroscopic rotator cuff repair.~   "
101361|NCT01730365|"~     Investigation of application possibilities of optical spectroscopy within the field of~     oncology. Optical spectroscopy enables the possibility to specifically differentiate between~     different (human) tissues. The hypothesis is that incorporation of this technique into~     existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of~     these devices. The purpose is to improve and speed up the diagnostics and therapy of the~     malignancies.~   "
101346|NCT01730560|"~     Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often~     cause problems with reading and visual exploration which impact on patients' quality of~     life. Apart from the substitutive method that uses prisms directly placed on glasses, two~     main rehabilitative methods have been explored previously: one restorative and one~     compensatory. The most effective methods seem to be based on compensatory training paradigms~     that target eye movements. They rely on voluntary mass-practice that induces changes in~     exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies~     using this method have shown changes in visual scanning patterns but with only a marginal~     profit in terms of functional benefit.~      In the present study, the investigators developed a new approach to the compensatory visual~     field training based solely on a bottom-up mechanism. It does not require the patients'~     ability to voluntarily maintain attention oriented to the affected field, which may be~     difficult for brain-damaged patients. As previously reported in other pathological contexts~     (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing~     voluntary and conscious implication of the patient can produce improvements by a more~     automatic process.~      The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by~     hemianopic patients to automatically improve targeted eye movements into their blind visual~     field; and 2) that this will lead to behavioural improvements on ecologically valid tests of~     visual search.~   "
101347|NCT01730547|"~     The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal~     stromal cells as treatment for Multiple Sclerosis.~   "
101348|NCT01730534|"~     This study is being carried out to determine the effect of dapagliflozin on cardiovacular~     outcomes when added to current background therapy in patients with type 2 diabetes with~     either established cardiovacular disease or cardiovascular risk factors.~   "
101349|NCT01730521|"~     Iron metabolism may undergo changes during exercise, with reductions in classical iron~     status markers due to a variety of postulated mechanism which include hemodilution,~     increased iron loss, hemolysis and increased iron storage in muscles. Furthermore, it has~     been reported that vigorous training increases hepcidin, a central regulatory peptide in~     iron metabolism. This increase has been ascribed to the presence of subclinical~     inflammation. Increased hepcidin levels may reduce iron bioavailability and iron~     incorporation in erythrocytes.~      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be~     generally healthy, with no history of blood donation in the last 6 months, should weigh less~     than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should~     have familiarity to sports and running, but not currently (i.e. in the past 3 months)~     training for more than 1h per week on average.~      The aim of this study is to measure an iron bioavailability during a resting and an exercise~     phase lasting approx. 14 days with training sessions on alternate days. Subjects will~     participate in both restign and exercising protocols and act as their own controls during~     the study. Iron bioavailability will be measured via the incorporation of stable isotopic~     labels 14 days after administration. To control for changes in blood volume during the~     course of the study, blood volume of the participating subjects will be measured before and~     after the exercise phase with the CO-rebreathing method.~      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase~     will allow determine if the increased level of hepcidin seen in in exercise will induce a~     lower iron bioavailability and iron incorporation during exercise.~   "
101350|NCT01730508|"~     This multicenter, prospective, observational study will evaluate the use in clinical~     practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese patients~     with HBeAg negative chronic hepatitis B. Patients receiving Pegasys according to the local~     label will be followed for the duration of their treatment and for one year after cessation~     of treatment.~   "
101351|NCT01730495|"~     The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic~     encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell~     depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis~     factor-alpha inhibition using Etanercept as weekly subcutaneous injections.~   "
101352|NCT01730482|"~     This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the~     contribution of metabolism and urinary excretion to its overall elimination as part of the~     continuing assessment of the safety and effectiveness of the drug.~      This is a Phase 1, single-site, open-label, single dose study of the absorption, metabolism~     and excretion of radiolabeled AT1001 in healthy male subjects between 30 and 55 years of~     age, inclusive. Six subjects will be dosed, with the goal of having at least 4 subjects~     complete the study through follow-up. All subjects will be screened within 28 days before~     admission to the Clinical Unit. Subjects will be confined to the clinical unit for 10 days~     after dosing and will return to the clinic for a follow-up visit 28 days after dosing.~      Each subject will receive a single oral dose of AT1001 as an aqueous solution containing 150~     mg [14C] AT1001 (1 μCi). Blood, duodenal bile, expired air, urine, and feces samples will be~     collected at specified time points after dosing throughout the period of confinement at the~     study site. Safety will be assessed throughout the study by monitoring clinical laboratory~     tests, ECGs, physical examinations, vital signs, and adverse events. The total duration of~     the study for each subject is approximately 8 weeks.~   "
101353|NCT01730469|"~     This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single~     dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects~     with normal renal function and to subjects with mild, moderate, and severe renal impairment.~   "
101354|NCT01730456|"~     This multicenter, open-label, single arm, long-term extension study will evaluate the safety~     and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe~     rheumatoid arthritis who completed the WA19926 core study. Patients will receive~     RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.~   "
101355|NCT01730443|"~     Blood samples will be drawn on traumatic brain injury patients who are participating in the~     ProTECT III study.~   "
101356|NCT01730430|"~     To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing~     patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.~     The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity~     and 60% specificity.~   "
101357|NCT01730417|"~     The goal of this proposal is to produce and test high specific activity Ultratrace~     iobenguane I 123 in normal human volunteers.~   "
101364|NCT01730326|"~     Patients with acute migraine attack make up the majority of patients consulting the~     emergency services due to headache. The aim of treatment in the emergency service is to~     achieve a minimum level of undesirable side effects and to quickly relieve the pain which~     will not repeat after discharge from the emergency service. Ideal drug treatment~     contraindication should be at a minimum level and not trigger migraine. Paracetamol and~     Nonsteroidal anti-inflammatory drugs are often used in the treatment of migraine headache.~      Although narcotic analgesics provide effective and rapid analgesia, they have such side~     effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the~     production of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic~     efficacy of these drugs has been one of the topics of interest to researchers. Especially~     intravenous form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory~     drugs, and it is a drug with a wide safety margin and less incidence of side effects. The~     effectiveness of the Intravenous form of paracetamol and whether it can be an alternative to~     other analgesics is one of the major research topics today, and more study is needed on this~     subject.~      Both drugs are often used in emergency services to treat headache caused by acute migraine~     attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with~     paracetamol in the treatment of the headache caused by acute migraine attack.~   "
101365|NCT01730313|"~     Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged~     5-15 years and characterized by head nodding, progressively worsening seizures, and~     cognitive impairment. To date, the cause of NS remains unclear. A recent assessment by the~     Uganda Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in~     Kitgum District in northern Uganda documented that the nodding episodes themselves resulted~     from atonic seizures, and that the children also exhibit multiple different seizure types,~     both clinically and electrographically. The investigation also found that there was~     significantly greater sero-positivity for onchocerciasis among children with NS compared~     with control children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine)~     among both cases and controls. Vitamin B6 is involved in neurotransmission and has been an~     effective treatment of seizures for certain rare type of epileptic syndrome. Children with~     nodding syndrome in Kitgum have been episodically treated with multivitamins, ivermectin,~     and anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and~     valproate, but the possible beneficial or harmful effects of any of these medications for~     nodding syndrome has not been systematically assessed, and reports from parents and~     guardians about apparent effectiveness are varied.~      The investigators propose a randomized blinded four group clinical trial with crossover~     design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6)~     and treatment with currently used conventional anti-epileptics including phenytoin and~     sodium valproate, among children with nodding syndrome.~   "
101366|NCT01730300|"~     The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing~     Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine~     bleeding. The patients were asked urogenital distress inventory (UDI) (which includes;~     irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact~     questionnaire (IIQ) (which includes; physical activity, travel, social/relationships,~     emotional health)questionnaires in the day of application LNR-IUD and six months later this~     procedure. Statistical analyse will be performed to evaluate the changes in this time~     period.~   "
101367|NCT01730287|"~     Deep carious lesions will encounter the dentist with the challenge of selecting a treatment~     method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional~     restorative treatments suggest complete removal of the caries in one visit which could cause~     pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root~     Canal Therapy (RCT).~      Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the~     possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp~     Capping (IPC), in this technique only the central infected part of the caries is removed in~     first visit and the rest of the caries will be lined by a suitable material to suppress the~     remained cariogenic biomass and seal the cavity. This will help the pulp to defend and~     survive. After a period, the cavity is re-opened and the rest of the caries which is darker,~     harder and with less bacteria will be removed and the tooth is restored permanently.The aim~     of this study was to compare the effect of different lining materials in clinical and~     radiographical symptoms in stepwise excavation without re-enter after one year.~   "
101368|NCT01730274|"~     Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional~     connectivity level in higher order cognition networks known to interact with the cerebellum.~     Furthermore, to correlate the connectivity level of these networks with the~     neuropsychological performance and functional outcome of the patients.~      The investigator's hypothesis is that the functional connectivity of various cognition~     networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging~     can be impaired after cerebellar tumor surgery and can be correlated with the~     neuropsychological performance. The effect of surgery on the cognition networks and the~     neuropsychological performance is dependent on the tumor location within the cerebellum.~     Such a correlation seems feasible as functional connectivity analysis could be correlated~     with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore,~     investigators were able to depict the maturation of the functional connectivity networks in~     parallel to the neurocognitive development in childhood~   "
101369|NCT01730261|"~     This study will examine the feasibility of online delivery of emotional regulation training~     to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional~     dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions~     twice a week for 12 weeks, delivered online in group modality. Attendance and compliance~     will be tracked, and outcomes will be monitored using online data collection methods.~     Treatment satisfaction and participant subjective experience will also be assessed.~   "
101435|NCT01729403|"~     This single-center, randomized, double-blind, placebo-controlled study will evaluate the~     effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who~     are inadequately controlled on metformin monotherapy. Patients will be randomized to receive~     either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their~     existing dose and regimen of metformin.~   "
122611|NCT01450969|"~     The PREFER Trial primary objective of the trial is to show how much radiation attenuation is~     provided by XPF in absolute and relative terms.~   "
101370|NCT01730248|"~     The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of~     INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated~     dose and or the Recommended Phase II dose of the combination guided by the Bayesian dose~     escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US~     and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical~     experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the~     pathway has been observed in MF models and may contribute to the pathogenesis of the~     disease.~   "
101371|NCT01730235|"~     The last mile of the medication use system requires tools to help patients comply with~     medication administration rules and monitor for side effects. Personal health records (PHR)~     and emerging user-adopted communication tools promise to change the landscape of medication~     management. The overarching goal of the MyMediHealth project is to investigate ways in which~     PHRs and supported applications can improve the safety and quality of medication delivery.~     Preliminary work in this area by a team of parents, patients and school/clinic health~     providers created a vision for MyMediHealth, a next-generation medication management system.~     MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to~     ensure safe and effective medication delivery. This vision featured just-in-time medication~     reminders to children with special health care needs, two-way communication to log when~     doses have been administered or when side effects have occurred, and mechanisms to warn~     caregivers about side effects and drug interactions. However, much of this work was done~     using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be~     carried out without significant changes in processes and policies, the purpose of this~     proposed study is to evaluate the impact of medication management tools such as MyMediHealth~     on medication adherence for children with chronic illnesses. Specifically, the investigators~     hypothesize that compared with usual practice, children using mymedihealth will have~     improved medication adherence and will report improved (decreased) asthma symptoms.~   "
101372|NCT01730222|"~     Four-drug combo yielded a statistically significant improvement in progression-free survival~     and overall survival compared to gemcitabine in patients with advanced pancreatic~     adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with~     pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and~     platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored.~      The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination~     with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the~     feasibility and the activity of the PAXG regimen in patients with stage III and IV~     pancreatic cancer.~   "
101373|NCT01730209|"~     Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in~     over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in~     up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian~     target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein~     complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal~     cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies~     suggests that mTOR inhibitors improve learning and development in patients with TSC.~   "
101374|NCT01730196|"~     Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation~     of the GLB program compared with a health education intervention.~   "
101375|NCT01730183|"~     This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate~     the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal~     cord injury patients.~   "
101376|NCT01730170|"~     Epilepsy is one of the most common neurological disorders affecting women of childbearing~     age. Poor pregnancy outcomes are increased in these women and their children. The proposed~     studies will increase our knowledge on multiple levels to improve care and reduce adverse~     outcomes in these mothers and children. An overall goal of this study is to establish the~     relationship between antiepileptic drug exposure and outcomes in the mother and child as~     well as describe and explain the variability in antiepileptic drug exposure and response.~   "
101377|NCT01730157|"~     This pilot clinical trial studies radioembolization and ipilimumab in treating patients with~     uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the~     blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal~     antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving radioembolization together with ipilimumab~     may kill more tumor cells in patients with uveal melanoma~   "
101378|NCT01730144|"~     Background:~      - One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus.~     Researchers want to better under how the live vaccine interacts with the body s immune~     system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt~     water) nasal spray. They will then look at blood and nasal cell samples to see how the~     vaccine affects these cells immune response.~      Objectives:~      - To look at immune changes in nasal and blood cells in people who receive live flu vaccine.~      Eligibility:~      - Healthy volunteers between 18 and 49 years of age.~      Design:~        -  Participants will have five outpatient visits for this study. Each visit will last up~          to 2 hours.~        -  At the first visit, participants will have a physical exam and medical history. They~          will give blood and urine samples. Nasal cell samples will also be collected.~        -  A week later, participants will have either the nasal spray flu vaccine or a saline~          spray. They will know which spray they will receive. Blood samples will be collected.~        -  Two days after the vaccination, they will have another physical exam. Blood and nasal~          cell samples will be collected.~        -  At the final two visits (1 week and 1 month after the vaccination), more blood samples~          will be collected.~        -  Those who had the saline spray will be able to have the actual vaccine spray at the~          last study visit.~        -  The ratio of participants who receive vaccine to those who receive saline will be 4:1.~   "
101507|NCT01728454|"~     The primary objective of this study is to determine the safety and efficacy of two oral~     doses of Proellex administered to premenopausal women with pelvic pain associated with~     endometriosis confirmed within the last seven years and using prescription analgesics for~     symptomatic pain.~   "
101379|NCT01730131|"~     Background:~      - Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain.~     It is caused by JC virus. Many people have this virus in their bodies all their life, but it~     is usually kept in check by their immune system. If the immune system does not work right~     because of a disease or medication, the virus becomes active and can damage cells in the~     brain. Not much is known about PML or how it affects the immune system. Researchers want to~     study people with PML to better understand the natural history of the disease.~      Objectives:~      - To study the natural history of PML.~      Eligibility:~      - Individuals at least 2 years of age who have PML.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies.~        -  Participants will have several visits to the National Institutes of Health Clinical~          Center. There will be an initial visit, monthly visits for the next 6 months, a~          12-month visit, and possible visits afterward.~        -  At the initial visit, participants will give blood, urine, and spinal fluid samples.~          They will also have neurological tests and imaging studies of the brain.~        -  For the next five visits, participants will give blood and urine samples. They will~          also have neurological tests and imaging studies of the brain.~        -  The 6-month and 12-month visits will repeat the tests from the initial visit.~        -  Other optional procedures include bone marrow samples and skin biopsies. Additional~          blood tests and imaging studies may be performed.~        -  Treatment will not be provided as part of this study.~   "
101380|NCT01730118|"~     Background:~      - HER2/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in~     several other types of cancers such as colon, prostate and non-small cell lung. Tumors that~     overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates,~     and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to~     stimulate the immune system to recognize HER2. The vaccine, called AdHER2/neu dendritic cell~     vaccine, is custom-made using an individual s own immune cells. These cells will be~     collected and used to produce the vaccine.~      Objectives:~      - To test the safety and effectiveness of AdHER2 vaccination.~      Eligibility:~      - Individuals at least 18 years of age who have HER2-expressing tumors.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will have an apheresis procedure to collect immune cells to create the~          vaccine.~        -  Participants will receive four doses of the vaccine at study Weeks 0, 4, 8, and 24.~        -  Participants will be monitored with physical exams, frequent blood tests and imaging~          studies....~   "
101381|NCT01730105|"~     Background:~      - Researchers are studying how metabolism and hormone levels change in response to mild~     changes in environmental temperature. Changes in metabolism may lessen with time because of~     hormonal adaptations. If this increase in metabolism continues for a longer period, mild~     cold exposure may cause weight loss. It is unclear whether exposure to a warmer temperature~     may cause opposite changes in metabolism. Researchers want to see if longer exposure (1~     month) to different temperatures can affect how the body uses energy.~      Objectives:~      - To test changes in energy metabolism in response to different room temperatures.~      Eligibility:~      - Healthy men between 18 and 40 years of age.~      Design:~        -  The entire study will last for 4 months. It will involve a screening visit and a~          4-month inpatient stay at the National Institutes of Health Clinical Center. The~          inpatient stay will be in a private room at the Metabolic Clinical Research unit. Study~          participants will be required to stay in the Metabolic Clinical Research unit during~          the night, but are free to leave during the day.~        -  At the screening visit, participants will have a physical exam and medical history.~          Blood samples will be collected. A heart function test and diet questionnaire will also~          be given.~        -  During the first month, the temperature of the private room will be set at to 75.2~          degrees F. This will allow the body to become used to the testing environment.~        -  During the second month, the temperature will be set to either a cool (66.2 degrees F)~          or a warm (80.6 degrees F) temperature.~        -  During the third month, the temperature will return to 75.2 degrees F.~        -  During the fourth month, the temperature will be altered to the opposite temperature to~          the one set in the second month.~        -  Throughout stay, participants will have daily temperature monitoring and will keep a~          food diary. Once a week, they will collect all of their urine for 24 hours. Once a~          month, they will spend 24 hours in a metabolic suite to study their metabolism rate.~        -  Throughout stay, the food will be provided as part of the study.~        -  During the first and third month (75.2 degrees F) the participants will be allowed to~          leave the Metabolic Clinical Research unit during the weekends, while during the second~          and forth month (66.2 or 80.6 degrees F), the participants will be allowed to spend one~          weekend out of the Metabolic Clinical Research unit.~        -  Other tests, such as body scans, fat tissue samples, and imaging studies, will be~          performed as needed.~   "
101382|NCT01730092|"~     Background:~      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a~     rare disorder. Some people have disease-associated PAH and some have PAH from an unknown~     cause. Researchers want to follow the natural history of all PAH patients to understand how~     PAH progresses in order to discover targets for future research into new treatments. To~     further identify treatment targets, they will compare healthy volunteers to patients with~     PAH.~      Objectives:~      - To study the natural history of PAH.~      Eligibility:~        -  Individuals at least 18 years of age who have PAH.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants with PAH will have periodic visits to the National Institutes of Health~          Clinical Center. After the first visit, they will return in 6 months and then yearly or~          every other year for as long as the study continues.~        -  The first visit will take up to 3 days. It will involve the following tests:~        -  Physical exam and medical history~        -  Blood and urine samples~        -  Heart and lung function tests and imaging studies~        -  Six-minute walk test~        -  Questions about exercise and physical activity~        -  Healthy volunteers will have only one visit to the Clinical Center, during which they~          will undergo screening tests, and complete many of the same tests as patients with PAH~   "
101383|NCT01730079|"~     Background:~      - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light~     to study brain function while allowing for movement. To look at blood flow in the brain,~     NIRS uses a low-power light source with detectors that see how the light changes as it~     passes through brain tissue. Brain blood flow can indicate which parts of the brain are~     active during different tasks. Researchers want to study children with attention deficit~     hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to~     compare the blood flow in the brain of children with ADHD and ASD with that of typically~     developing children.~      Objectives:~        -  To see how well NIRS can detect changes in brain blood flow during tests of thinking~          and memory in children.~        -  To compare blood flow in the brains of typically developing children and those with~          ADHD or ASD.~      Eligibility:~      - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric~     diagnoses.~      Design:~        -  Participants will be screened for eligibility. Those who are taking stimulant~          medication for ADHD or ASD will need to stop taking it for 3 days before the study~          visit.~        -  After participating in a screening assessment, all participants will have one study~          visit. At this visit, they will have be asked to complete two tasks during a NIRS scan.~          For both tasks, they will react to images on a computer screen. This visit will last~          about 2 hours.~        -  This is a testing study only. No blood or other samples will be needed for this study.~   "
101384|NCT01730066|"~     Surgery in the mouth and oropharynx is performed in an area colonised by bacteria~     non-pathogenic and pathogenic.~      Antibiotics are used regularly resulting in disturbances in the intestinal microbiological~     flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout~     the hospital stay for these difficult cases represent a risk of development of resistant~     strains.~      Most of the patients have cancer diagnoses and have radiation therapy before surgery. This~     increases the risk of the patients having pathogenic bacteria normally present in the lower~     GI-tract.~      The investigators have shown for ICU patients that treatment with probiotics reduces the~     number of emerging enteral bacteria in the oropharynx and now the investigators will perform~     an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.~      Patients will preoperatively gurgle a suspension of probiotics and then swallow the~     preparation.~      Postoperatively the probiotics is given enterally and a eventually by mouth again.~      Cultures will be taken from the oropharynx and tracheal secretions and the results will be~     compared~   "
101385|NCT01730053|"~     To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab~     (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia~     at high cardiovascular (CV) risk.~   "
101386|NCT01730040|"~     This is a randomized, double-blind, active-comparator, parallel-group study in patients at~     high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial~     hypercholesterolemia (heFH).~   "
101387|NCT01730027|"~     This randomised, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids~     and when co-administered with montelukast in patients with inadequately-controlled asthma.~     Patients will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.~   "
101388|NCT01730014|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous~     NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes~   "
101389|NCT01730001|"~     This study looks at advanced airway management in critically ill or injured patients treated~     by physician manned emergency medical services, comparing early (on-scene) intubation to~     late (emergency department) intubation.~   "
101390|NCT01729988|"~     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body~     removal in patients with high blood pressure (hypertension) resistant to medical treatment.~     Patients with high blood pressure are at significant risk of medical complications including~     stroke and heart disease. The principle research question is whether removal of the carotid~     body will lead to an improvement in the blood pressure of this patient group.~   "
101391|NCT01729975|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
101392|NCT01729962|"~     The primary purpose of this comparative clinical study is to collect clinical data to~     demonstrate the equivalence of the investigational device to the predicate device for~     measurements of the eye. The secondary purpose is to evaluate any adverse events that occur~     during the clinical study.~   "
101393|NCT01729949|"~     1. The primary objective is to determine the effect of fruit polyphenols on postprandial~          lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat~          breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and~          macro-/micro-nutrient matched control beverage (acute, Part 1).~        2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks~          (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and~          macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and~          markers of oxidative stress; and 2) to assess the effects of these beverages on~          meal-related changes in metabolic and oxidative stress measures after 8 weeks daily~          consumption.~   "
101394|NCT01729936|"~     Primary care centres are a key setting to treat people with overweight and moderate obesity.~     There is growing evidence that sitting for a long time is negatively associated with~     people's health. Interventions with the aim of reducing daily time of sedentary activities~     can be an effective strategy to increase daily energy expenditure. To improve the~     effectiveness of programmes promoting physical activity in primary care we need some clear~     action protocols that can be easily integrated in the daily routines of primary care~     professionals.~      Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary~     care intervention to reduce diary hours of sitting time in overweight and obese sedentary~     patients, as well as to increase their weekly caloric spend.~      Methods. The design of the study is a simple randomized controlled trial. Ten primary care~     centers will be invited to participate and will be randomized into control (CG) and~     intervention group (IG). Each professional will randomly invite to participate voluntarily~     moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25~     and 65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200~     individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be~     included in the study to know the feasibility of the intervention among them.~      The main dependent variable (sitting times) will be measured with an ActivPAL during first~     and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of~     the intervention. Other variables included in the study: number of steps walked, subjective~     level of physical activity, weight, height, BMI, skinfolds, waist circumference,~     triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood~     pressure and quality of life related to health. A descriptive analysis of all variables and~     a multivariate analysis to assess differences among intervention and control group will be~     undertaken. Multivariate analysis will be carried out to assess time changes of dependent~     variables. All the analysis will be done under the intention to treat principle.~   "
101395|NCT01729923|"~     This phase II trial studies how well capecitabine and celecoxib with or without radiation~     therapy works in treating patients with colorectal cancer that is newly diagnosed or has~     been previously treated with fluorouracil, and has spread to other parts of the body~     (metastatic). Drugs used in chemotherapy, such as capecitabine, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving capecitabine and celecoxib together with radiation therapy may kill more tumor cells.~   "
101508|NCT01728441|"~     Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to~     paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the~     femoropopliteal artery.~   "
101509|NCT01728428|"~     To determine the clinical manifestation, diagnosis and treatment options of primary~     hemifacial spasm in Chinese outpatient subjects~   "
101396|NCT01729910|"~     Child overweight has become one of today's most important public health concerns. Engaged~     and skilled parenting that models, values, and encourages healthy eating habits and a~     physically active lifestyle can play a key role in childhood overweight prevention and~     reduction. Primary care providers are well positioned to intervene with children and their~     parents, but face many barriers in addressing child overweight. A child overweight treatment~     approach is proposed for the primary care setting to facilitate parents' active involvement~     and self-efficacy in promoting healthy eating habits and physical activity for their~     children. We will test the following hypotheses: Hypothesis I (primary hypothesis): Children~     assigned to the intervention group will improve more in weight status (measured by BMI~     percentile) than children in the control group. Hypothesis II: Primary care providers~     assigned to the intervention group will improve more in their competence in addressing child~     overweight than the providers in the control group. Hypothesis III: After the intervention,~     parents in the intervention group will have more involvement and self-efficacy in promoting~     healthy weight for their children than parents in the control group. Hypothesis IV: Compared~     to the control group, the intervention group will improve more in family diet and eating,~     physical activity behaviors, as well as parental attitude and beliefs. Eighty children five~     to eleven years old who are overweight or obese will be recruited from two pediatric and two~     family practice clinics in southern Appalachia. Children will be randomly assigned to~     intervention and control groups based on clinic affiliation. Parents of children in the~     intervention group will participate in four clinic-based group sessions using the NIH We~     Can! curriculum moderated by a trained clinic provider, two individual brief motivational~     interviewing visits with their clinic provider, and four follow-up phone calls with the~     project coordinator or registered dietician. Parenting behaviors and attitudes, and family~     eating and activity habits, and children's weight status will be assessed at baseline, at~     the completion of the intervention, and at six months after the intervention. Changes in the~     assessments will be compared between treatment and control groups. Changes in provider and~     parent attitudes and perceptions about this treatment approach,adherence to the program, and~     estimates of associated time will be measured.~   "
101397|NCT01729897|"~     The study is designed to explore and compare the efficacy and safety of etomidate and~     propofol with or without analgesic for painless gastroscopy, and to provide more reliant~     support for implementation and promotion of comfort care.~   "
101398|NCT01729884|"~     This phase II trial studies how well vaccine therapy works in treating patients with stage~     IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body~     build an effective immune response to kill tumor cells.~   "
101399|NCT01729871|"~     The purpose of this exploratory study is to evaluate the safety of rivaroxaban and~     uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial~     fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major~     bleeding events.~   "
101400|NCT01729858|"~     The purpose of this research study is to identify reasons that cause an all-ceramic bridge~     to fracture which include the thickness of the bridge material, the type of bridge material~     and the bite force of the person. This all-ceramic bridge will be compared to a~     metal-ceramic bridge. The investigators are conducting this study so we can make bridges~     which can withstand forces in the mouth which tend to break them.~      The overall objective of this research is to analyze how properties of ceramic materials and~     different forces in the mouth interact with each other to affect the longevity of these~     bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting~     substrate, core thickness, connector height, wear, loading orientation, and maximum~     clenching force.~   "
101401|NCT01729845|"~     This phase I/II trial studies the side effects and best dose of decitabine followed by~     mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in~     treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has~     returned after a period of improvement or does not respond to treatment. Drugs used in~     chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more cancer cells.~   "
101402|NCT01729832|"~     Many hospitals, including the Ohio State University Medical Center, will take pictures of~     the blood vessels in a patient's abdomen before they decide to perform a breast~     reconstruction using the patient's own tissue. These pictures are called computed tomography~     (CT) angiograms and are like a map of each patient's anatomy. However, no study has been~     reported that determined how accurate these pictures are at showing the surgeon where all of~     the blood vessels were located. This study will try to determine if these pictures are~     missing any blood vessels that are found during surgery and if the pictures show the correct~     location of the vessels~   "
101403|NCT01729819|"~     The purpose of the study is to investigate the efficacy of combining tolterodine and~     desmopressin compared with tolterodine monotherapy in the treatment of women with overactive~     bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment~   "
101404|NCT01729806|"~     This partially randomized phase I trial studies the side effects and best dose of ipilimumab~     when given together with rituximab in treating patients with B-cell lymphoma that has~     returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and~     rituximab, may interfere with the ability of cancer cells to grow and spread.~   "
101405|NCT01729793|"~     The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a~     digestive enzyme dietary supplement product, on markers indicative of inflammation after a~     meal. The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha),~     interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein~     (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count~     (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times~     0 and 4 hours post-meal. In addition, a questionaire on Gastrointestinal symptoms will be~     administered 4 hours post-meal. The study hypothesis is that some or all of these potential~     markers of inflammation will increase following the meal, and the amount of increase in~     inflammation will be attenuated when a digestive enzyme is consumed with the meal compared~     to the placebo. In addition, it is hypothesized that levels of gastric discomfort as~     assessed by the questionaire will be reduced with the digestive enzyme compared to the~     placebo.~   "
101406|NCT01729780|"~     12% of patients suffering from an acute crornary syndrome will develop long lasting anxiety~     symptoms. The object of this study is to lessen or prevent these symptoms by the use of~     neurofeed back (EEG-NF).~   "
101436|NCT01729390|"~     The purpose of this research is to determine whether varying the energy density and portion~     size of the main course will affect meal energy intake after consumption of a first course~     that has previously been shown to enhance satiety. It is hypothesized that increasing either~     the energy density or portion size of the main course will increase meal energy intake after~     consumption of the first course. It is also hypothesized that compared to when a first~     course is consumed, not consuming a first course will increase meal energy intake.~   "
101510|NCT01728415|"~     The purpose of this study is to evaluate the effects of high intensity interval training~     compared to moderate exercise training and a control group on exercise capacity and quality~     of life in patients with end stage renal disease on hemodialysis.~   "
101407|NCT01729767|"~     Meniere's disease is a chronic illness that affects a substantial number of patients every~     year worldwide. The disease is characterized by intermittent episodes of vertigo lasting~     from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural~     pressure. It has recently been suggested that viral etiologies specially Herpes virus might~     be the underlying reason. The investigators study is a randomized, double- blinded~     placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective~     is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease~     specially their vertigo attacks. Inclusion criteria would be patient's willingness to~     participate in the study and follow ups, being 18 years old or older, having at least 2~     vertigos per month each at least 20 min, interfering with function, and not on medication~     for Meniere's disease for at least 3 months before the trial. They should not have any~     history of allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic~     enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing~     or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2~     different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take~     the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a~     day for the last 10 days. Patients will report changes in their symptoms 10 days after~     initiating the drug and in 1, 3, 6 month intervals.~   "
101408|NCT01729754|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of~     tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe~     plaque psoriasis.~   "
101409|NCT01729741|"~     Thyroidectomy is one of the most commonly performed operations in general surgery. Available~     data seem to suggest an association between no-drain usage and a shorter duration of~     hospital stay. Seung et al found that the (following thyroidectomy) time to discharge after~     thyroidectomy was significantly shorter in the no drain group compared to the drain group.~     Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported~     the incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%.~     Tahsin et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of~     an hematoma enlarging and obstructing the airway and causing difficulty in breathing,~     prompts many surgeons to use drains routinely after any type of thyroid surgery. The main~     reason is to drain off a possible postoperative hemorrhage, which may compress the airway~     and produce respiratory fail~   "
101410|NCT01729728|"~     To find out if a drug called tapentadol administered by mouth safely relieves pain in~     children. Look at the amount of tapentadol in the blood after a single oral dose.~      Tapentadol oral solution for children is still being tested and is not yet registered.~     Tapentadol tablets are effective in treating both acute and chronic pain in adults. This~     trial will help to understand how tapentadol oral solution works in children.~   "
101411|NCT01729715|"~     The investigators are conducting a randomized trial of behavioral treatments for young~     children with insomnia. The investigators are comparing the improvement in sleep patterns~     after families are given access to Internet sleep instructions compared to DVD sleep~     instructions.~   "
101412|NCT01729702|"~     The primary purpose of this study is to demonstrate that changes in plasma levels of~     circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise~     correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise~     ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)~   "
101413|NCT01729689|"~     This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in~     patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral~     therapy may reduce anxiety and improve the well-being and quality of life of patients who~     have stage IV non-small cell lung cancer and their caregivers.~   "
101414|NCT01729676|"~     French epidemiological data have shown a heterogeneous distribution of the risk of mortality~     from prostate cancer according to region. The main objective is to describe the distribution~     of prostate cancer stages when first line hormonal therapy is introduced (overall and by~     region).~   "
101415|NCT01729663|"~     Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,~     allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon~     alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous~     melanoma patients. This study has been approved by ANMAT ( Administración Nacional de~     Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).~      The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma~     de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).~      Study population include a total of 108 patients (72 patients will receive CSF470 vaccine~     and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.~      CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then~     one dose every two months for the first year and them every three months for the second~     year.~      Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,~     not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first~     day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.~      IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for~     four weeks and then 5 MU (3t/w) for 23 months.~      Both treatments will also compare quality of life (QOL) and study a possible correlation in~     the CSF470 vaccine arm between the induced immune response and clinical outcome~   "
101437|NCT01729377|"~     The purpose of the proposed study is to examine the phenomenon of suicidality in old age and~     its unique characteristics. This will be performed through observing the multigenerational~     aging family from the life-course perspective, which enables the researchers to address life~     transitions, including crises leading to suicidal tendencies.~   "
101438|NCT01729364|"~     Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients~     postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen~     demand.~   "
101439|NCT01729351|"~     To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF~     HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK,~     specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK~     primary care asthma population of current smokers.~   "
101416|NCT01729650|"~     The aim is to evaluate the effectiveness of an intervention based on a program of physical~     activity and diet coordinated between primary care teams (PCT) and Mental Health Centres~     (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist~     circumference in patients with severe mental disorder diagnoses. To assess changes in~     cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized~     clinical trial with a control group, of one year of follow-up, carried out in four MHC~     Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18~     - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with~     antipsychotic medication and a low level of PA. 240 patients will be selected in each group~     (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:~     group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8~     sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of~     PA (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,~     cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED~     questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.~     Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for~     repeated measures to adjust for differences attributable to the effect of the intervention~     for potential confounders: pharmacological treatment, care level of intervention and mental~     state.~   "
101417|NCT01729637|"~     In order to minimize mechanical stress the investigators propose to implement EVLP procedure~     with a ventilation monitoring guided by the analysis of the Paw-t shape.~   "
101418|NCT01729624|"~     A qualitative study using interviews with patients who have antineutrophil cytoplasm~     antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure~   "
101419|NCT01729611|"~     Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary~     vascular resistance that can lead to right heart failure and death. Several diseases are~     known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the~     context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival~     of the connective tissue or liver disease.~      Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for~     screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less~     than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing~     need to identify methodologies that can accurately and non-invasively recognize the presence~     of PAH in patients with scleroderma and cirrhosis.~      Hypothesis:~        1. To measure endothelial function and exhaled gases in patients with scleroderma and~          cirrhosis. To assess whether they correlate with the presence or the development of~          PAH.~        2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis~          identifies patients who will develop PAH and in those already diagnosed PAH predicts~          response to PAH-specific therapies.~   "
101420|NCT01729598|"~     The purpose of this study is to evaluate the safety of administration and effects of~     valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects.~     Clusterin mutations have recently been identified as a risk factor for the development of~     Alzheimer's Disease and changes in clusterin expression are seen in the elderly who develop~     Alzheimer's disease irrespective of whether they carry these genetic mutations or not.~     Valproic acid may prevent or reverse these changes.~      Fourteen subjects with normal memory and thinking will participate in this study. Ten of~     these subjects will receive valproic acid and 4 will receive a placebo capsule with no~     active medicine. Participants will take study medication or placebo for 28 days and be~     followed for a total 35 days in this trial.~   "
101421|NCT01729585|"~     The purpose of this study is to describe the effects of massage therapy on quality of life~     (QOL) in youth and young adults (ages 8 to 21 years) with cystic fibrosis (CF).~   "
101422|NCT01729572|"~     Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing~     remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia~     outcome remains very limited, mainly due to very poor adherence to medications by the~     patients. This study aims to find, whether the add-on of remote monitoring of medication~     compliance via tele-medicine, to routine out-patient clinic care, can improve patients~     adherence and reduce the risk of relapse.~   "
101423|NCT01729559|"~     The rate of venous thromboembolic events in trauma patients at high risk for deep vein~     thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours~     will be equivalent or less than a similar group of patients given a standard every 12 hour~     dose of low molecular weight heparin.~   "
101424|NCT01729546|"~     In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and~     several POCT (point-of-care testing) devices against two laboratory methods will be~     performed. This evaluation will be performed according to ISO (International Organization~     for Standardization) 15197 System Accuracy.~   "
101425|NCT01729533|"~     The (motile sperm organelle morphology examination) MSOME allows the detection of sperm~     vacuoles that seems to be related to sperm DNA damage.~      The investigators hypothesized that couples with unexplained infertility could benefit from~     the injection of spermatozoa selected under high-magnification (x6600)~   "
101440|NCT01729338|"~     The primary purpose of this study is to estimate the overall response rate (ORR), defined as~     partial response (PR) or better at any time during induction therapy. The success of the~     therapy will be determined by ORR with strong consideration given to the secondary endpoints~     of tolerability, duration of response, and quality of life (QOL).~      All patients will be treated with the same experimental regimen. Several novel features are~     being explored: the substitution of cyclophosphamide for melphalan; once weekly AND~     subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and~     alternating bortezomib and lenalidomide in maintenance.~      The investigators hypothesize that this regimen will prove to be tolerable and effective in~     inducing and maintaining remission in a patient population that is historically very~     difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer~     comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies~     like autologous stem-cell transplantation (ASCT). In short, the investigators view this as~     the Multiple Myeloma trial for non-trial candidates.~   "
102672|NCT01713192|"~     The purpose of this registry is to obtain perioperative data in patients undergoing cardiac~     surgery and find out relations between the data and investigate several causes affecting~     postoperative complications.~   "
101426|NCT01729520|"~     Background:~      In the early phase after a total knee arthroplasty (TKA), patients experience multi-level~     weakness in the operated leg, which is caused primarily by reduced central nervous system~     (CNS) activation failure of the muscles - especially the knee extensors. This considerable~     loss of muscle strength relates to reduced functional performance. Early-commenced,~     progressive strength training of the knee extensors of the operated leg therefore seems~     rational. However, the concern is that this type of early-commenced, intense physical~     rehabilitation exacerbates post-operative symptoms, such as knee joint pain.~      The investigators have recently reported that early-commenced physical rehabilitation,~     including progressive strength training of the knee extensors of the operated leg seems~     feasible after TKA. The classic exercise-physiology literature emphasizes loading and~     repetitions performed to contraction failure - among others - as important variables for~     muscle hypertrophy and strength gains. It is currently not known how loading and repetitions~     performed to contraction failure during knee extensions with the operated leg, influences~     post-operative knee joint pain in patients with TKA.~      Purpose and hypothesis:~      The purpose of this study is to investigate how loading and repetitions to contraction~     failure influence knee joint pain during knee extensions with the operated leg early after~     TKA.~      The hypothesis is that knee pain increases with increasing loading and fatigue.~      Methods:~      Fifteen patients with a unilateral TKA, operated between 1 to 2 weeks prior to the first~     investigation, will be included. The participants are investigated twice. During the first~     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a~     load that can be lifted exactly 10 times) will be determined for unilateral (operated leg)~     knee extension. At the second investigation, at least 72 hours later, the patients will~     perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a~     randomized order, estimated from their 10 RM test at the first investigation. Time under~     tension (contraction velocity) and range of knee joint motion for each repetition will be~     controlled for. During the concentric phase of each repetition, the patients rate their knee~     joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a~     short break, the patients perform 1 set of knee extension with a relative loading of 10 RM~     until of contraction failure. As for the loading effect described above, they rate their~     knee joint pain during the concentric phase of each repetition.~   "
101427|NCT01729507|"~     As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial~     direct current stimulation (tDCS) significantly increases the cessation rate compared to~     treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after~     completion of the smoke-free programme in combination with tDCS.~      Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum~     treatment group compared to the sham tDCS group.~      tDCS is suitable for use in larger groups (8-12 people).~   "
101428|NCT01729494|"~     The study purpose is to determine the safety and efficacy of a belatacept-based~     immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit~     antithymocyte globulin induction and early glucocorticoid withdrawal (CSWD) and a~     belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit~     antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant~     recipients.~      The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab~     induction, MMF/MPA, and early glucocorticoid withdrawal (Group A) in renal transplant~     recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin~     induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of~     graft loss, patient death, or reduced renal function at 12 months as compared to a~     tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and~     early glucocorticoid withdrawal in renal transplant recipients (Group C).~   "
101429|NCT01729481|"~     In the current study it is examined whether patients with good risk factors (age <75 years,~     total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with~     gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of~     treatment have a comparable outcome as patients who receive FOLFIRINOX.~   "
101430|NCT01729468|"~     The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given~     bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous~     pregnant women selected as high-risk by the presence of a bilateral uterine artery notch~     and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6~     weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.~   "
101431|NCT01729455|"~     The purpose of this registry is to collect additional information regarding the side effects~     and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults~     with active systemic lupus erythematosus (SLE). Information will be collected on serious~     events that are not that common or may only be seen with long-term treatment. These events~     include death, cancers, serious infections and other infections of interest, and serious~     mental health problems. Information on the effectiveness of BENLYSTA will also be collected.~   "
101432|NCT01729442|"~     Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for~     prostate cancer that is currently assessed in two indications: as a first-line treatment~     (either total or focal) for patients who are not eligible for surgery and as a salvage~     treatment of local recurrences after radiotherapy.~      It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess~     the position and volume of tissue destruction at the end of prostate HIFU ablation. This can~     provide live feedback regarding the amount of residual non ablated tissue after HIFU~     treatment, which could allow immediate re-treatment in case of unsatisfactory result.~      CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco,~     Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is~     necessary to wait 20 to 30 minutes before re-treating the patient.~      Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can~     quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than~     undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the~     purpose of this study is to evaluate the accuracy of SWUE in depicting the position and~     volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound~     (HIFU) ablation.~      The present study is an exploratory, monocentric, prospective, descriptive study. Three~     groups of 10 patients with prostate cancer will be evaluated: patients referred for~     first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation~     (focal treatment) and patients referred for salvage HIFU after radiotherapy.~      SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation~     (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and~     D0 SWUE.~      The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured~     by SWUE and CEUS.~      The secondary endpoints are:~        -  The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0~          and D+1,~        -  Adverse events related to SWUE.~      The study will last 40 months.~   "
101433|NCT01729429|"~     This randomized controlled trial is designed to evaluate whether a behavioral intervention~     that includes three components: 1) reminder letters and education materials delivered before~     the clinic visit, 2) telephone recalls after the visit for those who originally decline the~     vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1~     and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls~     attending four Parkland primary care clinics in Dallas county.~      Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the~     Intervention group than those in the General Adolescent Vaccine Brochure group.~      Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among~     patients in the Intervention group who initially declined the vaccine than those in the~     General Adolescent Vaccine Brochure group who initially declined.~      Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among~     the Intervention group than those in the General Adolescent Vaccine Brochure group.~   "
101434|NCT01729416|"~     The purpose of this study is to determine if screening colonoscopy performed on adults with~     the water exchange method, as opposed to the air method, will have a higher adenoma~     detection rate.~   "
101441|NCT01729325|"~     Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and~     are often exposed to multiple traumatic events and situations in which they are forced to~     engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to~     reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other~     mental disorders as a result of traumatic experiences. The effective prevention of mental~     disorders as a result of war deployment is expected to facilitate reintegration in civil~     life after deployment and reduce uncontrolled violence.~   "
101442|NCT01729312|"~     To make reading this consent form easier, the word you refers to you or your child (if a~     minor) throughout the consent form. This research is being done to study the effects of an~     eighteen-session strengthening program and to see if there is a relationship between the~     female athletes improving their landing techniques which has been proven to decrease~     anterior cruciate ligament injuries.~      You have been asked to take part in a research study because you are a female athlete~     involved in a sport that has an increased anterior cruciate ligament injury rate. The~     purpose of this research study is to find out if an eighteen-session strengthening program~     will decrease your anterior cruciate ligament injury rate.~      There will be approximately ninety-four (94) people in this research study at Henry Ford~     Health System (HFHS).~   "
101443|NCT01729299|"~     To determine the role of nutrient status on ghrelin regulation of insulin secretion. We~     hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the~     gut,) have differential effects on β-cell function in the fed state. We will compare insulin~     secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed~     meal protocol in subjects receiving ghrelin or saline. We will also determine the role of~     ghrelin-stimulated GLP-1 levels in this process using the GLP-1 receptor (GLP-1R) antagonist~     Exendin(9-39) (Ex-9).~   "
101444|NCT01729286|"~     The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy~     (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in~     subjects with diabetes mellitus and without significantly compromised arterial circulation.~   "
101445|NCT01729273|"~     The purpose of this study is to assess exercise performance in 20 healthy children 10-19~     years of age with a body mass index greater than 85th percentile and to evaluate the effect~     of dietary and exercise intervention over 12 weeks.~   "
101446|NCT01729260|"~     The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be~     safely given to people with malignant brain tumors in combination with the current standard~     of care (temozolomide) without causing severe side effects. We also want to find out if MBZ~     can slow the growth of the brain tumor. The study doctors have found that MBZ is effective~     against malignant brain tumors in the laboratory and animal models of brain tumors.~   "
101447|NCT01729247|"~     Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.~      Secondary objectives: Evaluate the ability of physicians to correctly assess airway~     inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement).~     Estimate the cost consequences of changes in asthma management following FeNO determinations~      Number of participants: Approximately 40 to 50 subjects will participate in the study during~     an (approximately) 8-12 week study enrollment period.~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be~     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®~     User Manual (February, 2011).~      Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4)~     FeNO has been measured and seen by the Physician/Health Care Practitioner.~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan (CIP) from the time that informed~     consent has been provided and during the study period~      Criteria for evaluation: This is an observational, pilot study and there are currently no~     plans for a formal statistical analysis. Information gained from this study may be used to~     design subsequent studies in subjects with asthma. Data collected will be summarized in a~     clinical study report but will not be subject to formal hypothesis testing~   "
101448|NCT01729234|"~     Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular~     function in healthy volunteers with particular emphasis on age-related alterations.~   "
101449|NCT01729221|"~     Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C~     virus infected patients after stem cell therapy.~   "
101450|NCT01729208|"~     The purpose of this study is to determine whether a new type of soft contact lens with a~     unique optical design (dual focus) is effective at slowing the progression of myopia~     (near-sightedness) in children.~   "
101451|NCT01729195|"~     This single-center randomized trial evaluates the efficacy and safety of a new bone screw~     (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber~     C-type ankle fractures. The comparison is made to subjects treated by conventional metal~     screw fixation of the syndesmosis. The primary objective is to show that the antibiotic~     releasing bioabsorbable screw is at least as good as the routinely used metal screw in~     prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The~     secondary objective is to show that the clinical outcome of the ankle fracture treatment is~     equal between patients treated by the antibiotic releasing bioabsorbable screw and the~     conventional metal screw.~   "
101452|NCT01729182|"~     The purpose of this investigation is to collect following data in patients given Nexium~     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence~     of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).~   "
101469|NCT01728961|"~     The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way~     artemether/lumefantrine (AL) works in children who are co-infected with both HIV and~     malaria. The brand of AL used in this study is Coartem® Dispersible. This study will compare~     the blood levels of AL in co-infected children who already take NVP prescribed by their~     doctor with the co-infected children who do not take anti HIV medicines because they do not~     meet national guidelines to start them. The study will also assess the safety of using both~     medications (AL and NVP) in children.~   "
102555|NCT01714726|"~     The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared~     to placebo. Investigational product will be administered as intravenous infusion in~     double-blind period, and as a subcutaneous injection in open-label period~   "
101453|NCT01729169|"~     Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has~     proved effective and cardiac biopsies have a very low sensitivity.~     18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of~     fasting has previously been demonstrated to have reasonable accuracy, however, in some~     patients physiological FDG uptake in the cardiac region hampers correct identification of~     sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue~     Nal3-octreotide (NOC) and gallium Ga 68-labeled~     1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study~     whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing~     cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting~     with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.~   "
101454|NCT01729156|"~     Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.~     Whereas there is general agreement that the blood glucose lowering effect of metformin~     results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug~     lowers blood triglyceride concentration. There are indications that it enhances hepatic free~     fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion~     as very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily~     accessible for sampling in humans and data on the clinical effects of metformin in the liver~     are therefore lacking. This may change due to the increasing use of the positron emission~     tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a~     fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.~      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic~     lipid metabolism in patients with newly diagnosed type 2 diabetes.~      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving~     either metformin or placebo. A control group of BMI and age-matched healthy controls will~     receive metformin for 3 months.~      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing~     hepatic fatty acid oxidation~   "
101455|NCT01729143|"~     As obesity rates worldwide continue to increase, there is a focus on identifying active food~     ingredients which increase metabolic rate which can be used as a dietary supplement in the~     treatment of overweight and obesity. Promising animal and cell studies have suggested a role~     for black pepper and an active component of black pepper, piperine, in energy expenditure.~     However, the effects of black pepper have not been determined in humans. The investigators~     hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one~     day) will result in an elevation in 24-h resting energy expenditure when contrasted to a~     control day (no black pepper, same diet intake).~   "
101456|NCT01729130|"~     Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do~     not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is~     a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular~     disease (CVD). These biomarkers also can become additional outcome measures for an~     intervention such as pancreatic/kidney transplant. If biological markers show an improvement~     with an intervention before anthropometric changes occur, intermediate outcomes can be an~     encouraging finding for practitioners. This study will focus on the central question of~     adipose tissue dysfunction as mediator of metabolic complications of positive energy~     balance, independent of body fat content and distribution. This study will address the~     question of effect of hyperglycemia on adipose tissue function independent of body fat mass.~     This project will take advantage of unique expertise of our investigators to perform~     detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney~     transplant. The results of the proposed study will provide support to the novel approach of~     identifying adipose tissue dysfunction, rather than obesity and fat distribution, as~     predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain~     necessary preliminary data for future grant submissions to support our central hypothesis~     and develop stronger interactions within and outside The University of Texas Medical Branch~     (UTMB) with clinical investigators in the area of DM and its complications.~   "
101457|NCT01729117|"~     Background and Rationale Research studies have shown that patients with type 2 diabetes~     (T2DM) who lose weight have better glucose control and less risk for heart disease. It has~     been difficult to achieve these results in a non-research setting. Meal replacements (MR)~     are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a~     weight loss program by reducing decision-making and facilitating target caloric intake. The~     University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal~     Clinic has demonstrated acceptability and success of MRs in conjunction with a structured~     lifestyle modification program in achieving weight loss in underserved Hispanic T2DM~     patients.~      Objectives Our short-term objective is to determine the efficacy, safety and feasibility of~     a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification~     program in a clinic setting. Our longer-term goal is to acquire data for sample size and~     power estimates for a larger NIH- or other funded prospective, randomized trial.~      Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated~     with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The~     SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive~     MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1~     consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month~     transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of~     a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600~     calories/day for women and 1800 to 2000 calories/day for men. Individual and group~     educational, support and counseling visits will be components of all 3 phases of the study.~      Outcomes Efficacy of the program will be determined by weight, waist measurement and waist~     to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9~     and 12 months. These are all measurements that are done routinely in these patients. Safety~     will be determined by monitoring of adverse events.~      Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to~     determine if there is evidence that the intervention improves outcomes and is safe.~   "
101458|NCT01729104|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     carfilzomib that can be given in combination with lenalidomide and rituximab to patients~     with relapsed or refractory B-cell non-hodgkin lymphoma.~      The goal of Part 2 of this study is to learn if the drug combination can help to control~     B-cell non-hodgkin lymphoma.~      The safety of this drug combination will be studied in both parts.~      Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer~     cells to die. It is also designed to cause the immune system to attack cancer cells.~   "
102673|NCT01713179|"~     Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties~     that are also found in mucolytic agents.1 Ambroxol has been used for decades for the~     treatment of respiratory disorders associated with excessive mucus, including chronic~     inflammatory pulmonary conditions, bronchitis, and pneumonia.2,3 The drug changes the~     biophysical properties of secretions by degrading the mucin polymers, deoxyribonucleic acid,~     fibrin in airway secretions, and by generally decreasing viscosity.4 In addition, ambroxol~     increases cyclic nucleotide (cAMP or cGMP),5 which can theoretically increase tear~     secretion.6 Many systemic medications, such as antihistamines, antidepressants, diuretics,~     acne drugs, and certain blood pressure medicines can cause or exacerbate a dry eye.7,8 On~     the other hand, several topical medications, including mucolytics such as ambroxol and~     bromhexine, may be used to treat tear-deficient dry eyes by promoting lacrimal gland~     function.9 However, the effects of mucoactive agents on the tear film have not been~     investigated systemically, and mucoactive agents may have a disturbing effect on the tear~     film because they modify mucin.10,11 The tear film is composed of 3 unique layers, including~     the outermost lipid layer, the middle aqueous layer, and the innermost mucus layer; this~     structure enables it to perform many functions.12 The lipid layer acts as a barrier to~     prevent tear film evaporation, and the aqueous layer supplies oxygen and important nutrients~     to the cornea.13 The mucin layer, secreted mostly by conjunctival goblet cells, coats the~     corneal surface rendering it hydrophilic, and anchors the tear film to the corneal~     surface.14 Deficiencies in the amount of tear production or alteration in tear composition~     can lead to ocular surface disease.15 Although many studies have focused on~     aqueous-deficient dry eye syndrome,16-18 the effect of mucin layer defects on the tear film~     has not been thoroughly studied. Furthermore, very few reports have determined the effects~     of oral mucolytic agents on the tear film and ocular surfaces, although a study has reported~     that filamentary keratopathy was treated with debridement of filaments and application of~     topical mucolytic agents such as acetylcysteine eyedrops. In the present study, we~     investigated the effects of oral ambroxol on tear film and ocular surface.~      Reference~        1. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical~          update. Expert Opin Drug Metab Toxicol 2008;4:1119-1129.~        2. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care~          2007;52:859-865.~        3. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care~          2007;52:1176-1193.~        4. Gupta PR. Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in~          chronic obstructive airway diseases. Lung India 2010;27:46-48.~        5. Anfossi G, Russo I, Massucco P, et al. Adenosine increase human platelet levels of cGMP~          through nitric oxide: possible role in its antiaggregating effect. Thromb Res~          2002;105:71-78.~        6. Gilbard JP, Rossi SR, Heyda KG, et al. Stimulation of tear secretion by topical agents~          that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci 1990;31:1381-1388.~        7. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol~          2009;3:405-412.~        8. Terry MA. Dry eye in the elderly. Drugs Aging 2001;18:101-107.~        9. Calonge M. The treatment of dry eye. Surv Ophthalmol 2001;45:227-239.~       10. Yamada T, Takemura Y, Niisato N, et al. Action of N-acylated ambroxol derivatives on~          secretion of chloride ions in human airway epithelia. Biochem Biophys Res Commun~          2009;380:586-590.~       11. Hasegawa I, Niisato N, Iwasaki Y, et al. Ambroxol-induced modification of ion transport~          in human airway Calu-3 epithelia. Biochem Biophys Res Commun 2006;343:475-482.~       12. Antti H, Tuulikki S, Matej O. Human tear fluid lipidome: from composition to function.~          PLoS One 2011;6:e19553.~       13. Ohashi Y, Dogru M, Tsubota K. Laboratory findings in tear fluid analysis. Clin Chim~          Acta 2006;396:17-28.~       14. Davidson HJ, Kuonen VJ. The tear film and ocular mucins. Vet Ophthalmol 2004;7:71-77.~       15. Bhavsar AS, Bhavsar SG, Jain SM. A review on recent advances in dry eye: pathogenesis~          and management. Oman J Ophthalmol 2011;4:50-56.~       16. Patel S, Farrell J, Blades KJ, et al. The value of a phenol red impregnated thread for~          differentiating between the aqueous and non-aqueous deficient dry eye. Ophthalmic~          Physiol Opt 1998;18:471-476.~       17. Lin H, Li W, Dong N, et al. Changes in corneal epithelial layer inflammatory cells in~          aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2010;51:122-128.~       18. Yokoi N, Yamada H, Mizukusa Y, et al. Rheology of tear film lipid layer spread in~          normal and aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2008;49:5319-5324.~   "
101459|NCT01729091|"~     The goal of this clinical research study is to find the highest tolerable dose of immune~     cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell~     transplant to patients with myeloma. Researchers want to learn if adding NK cells will help~     make the stem cell transplant more effective in treating the disease. The safety of this~     treatment will also be studied.~      NK cells may kill myeloma cells that remain in your body after your last chemotherapy~     treatment. The NK cells are separated from the umbilical cord blood sample. These separated~     NK cells will then be grown (manipulated) in the lab to increase the number of NK cells~     that can be given to you by vein.~      Lenalidomide (Revlimid) is designed to block a protein that plays a role in cell function~     and growth, which may cause cancer cells to die.~      Melphalan is designed to attach to the DNA (genetic material) of cells, which may cause~     cancer cells to die. It is commonly used in stem cell transplantation.~   "
101460|NCT01729078|"~     Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre~     diabetes subjects. Subjects will be randomized to either high fat (olive oil~     supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.~     Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by~     magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting~     dietary intervention.~   "
101461|NCT01729065|"~     This study will determine whether patients who receive regular physical therapy immediately~     following a modified neck dissection surgery will report decreased shoulder disability,~     decreased pain, improved or maintained shoulder range of motion and strength, and improved~     quality of life than those who receive only home instruction.~   "
101462|NCT01729052|"~     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.~     However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant~     adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is~     appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are~     minimal.~      The objective of this multicentre, double-blinded, randomized, controlled trial is to~     investigate whether acupuncture can be a supplementary to the ordinary treatment in children~     undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of~     parental attitudes and expectations on the outcomes will be explored.~      Two hundred and eighty patients will be included and randomized into two groups~        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during~          anaesthesia and standard treatment~        2. Control group: standard treatment~      The primary endpoints in the intervention study are nausea, retching, vomiting and pain~     during 24 hours postoperatively. The effect of acupuncture will be studied with regard to~     any association with possible factors of predisposition to PONV, as well as with other~     factors registered during the study. Adverse events from acupuncture will be registered.~      The objective of the self-report questionnaires is to~        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and~          postoperatively~        -  compare data of the outcomes from the intervention trial with data from the~          questionnaires, in order to find any correlation between parental beliefs, attitudes~          and expectations, and the effect of the acupuncture treatment~   "
101463|NCT01729039|"~     The purpose of this study is to determine whether vestibular exercises provide added benefit~     to balance rehabilitation in older adults with dizziness and normal vestibular function.~   "
101464|NCT01729026|"~     The purpose of this study is to provide preliminary data on the feasibility and impact of~     adopting a dog from an animal shelter as a supplement to usual care in Veterans with~     Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.~   "
101465|NCT01729013|"~     Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin~     D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues.~     The capacity for vitamin D storage in adipose tissue is not known, nor the importance of~     such storage which may potentially be of vital importance when intake or solar exposure is~     limited. In the present study we will include 76 subjects who have participated in an~     intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of~     type 2 diabetes, and who have completed the study after 5 years or who have been excluded~     because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any~     extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a~     considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D~     during the following year without vitamin D substitution, which will be measured in the~     present study. If our hypothesis is correct, that vitamin D can be stored in significant~     amounts when the supply is abundant; current advice on vitamin D supplementation mainly~     during winter should be changed to year around in order to build up sufficient stores for~     the months without sufficient sun light.~   "
101466|NCT01729000|"~     The purpose of this study is to compare the additional use of gloves (with handwashing~     before and after gloving) for all patient contact while infants have intravenous (central or~     peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational~     age will be randomized after birth to either a handwashing-gloving group or handwashing only~     group. The primary outcome will be the incidence of invasive infections (bacterial or~     fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm~     morbidities, mortality, and hospital costs.~   "
101467|NCT01728987|"~     The study will examine the role of adipose tissue in vitamin D physiology, particularly its~     role as a depot. the study is randomized double blind and placebo controlled.~   "
101468|NCT01728974|"~     In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms~     that lead to airway closure are not completely understood. While the airway of some people~     narrows and airflow decreases during inspiration due to increasing inspiratory effort,~     others maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may~     protect against airway narrowing that occurs due to increasing inspiratory effort. To test~     this hypothesis, the investigators will initially measure airway neuromuscular reflex and~     inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal~     anesthesia to observe the effects on inspiratory flow.~   "
101709|NCT01725789|"~     This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic~     anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective~     measures (Hb and iron parameters).~      Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.~   "
101470|NCT01728948|"~     This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65~     years, no prior systemic treatment, determined to be candidates for systemic therapy by the~     investigator. The treatment with Sorafenib should comply with the recommendations written in~     the local product information. The primary endpoint is overall survival. The secondary~     endpoints including other effectiveness points, safety and patients characteristics. With~     120 completed patients, if the observed survival rate at 12 months is 60%, the width of a~     95% confidence interval will be approximately 18%.~   "
101471|NCT01728935|"~     Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B~     virus (HBV) in various multiple-centre trials, with no cases of resistance encountered.~     However, its efficacy and resistance profile in the Asian population, which constitute the~     majority of chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside~     analogues, TDF has been associated with relatively high rates of hepatitis B surface antigen~     (HBsAg) seroclearance. It would be interested to see if this could be reproduced. The~     investigators plan to report the serologic and virologic results of our 140 nucleoside~     analogue-experienced patients who were commenced on TDF.~   "
101472|NCT01728922|"~     The primary purpose of this study is to assess the immune response to vitamin D~     supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and~     patients with clinically isolated syndrome compared to placebo. Secondary endpoints include~     (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and~     evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used~   "
101473|NCT01728909|"~     The purpose of the study is to examine the effects of intranasal oxytocin administration on~     social cognition in patients receiving methadone maintenance treatment (MMT), examine the~     effects of intranasal oxytocin administration on opioid craving and on the subjective~     effects of methadone, and examine the effects of intranasal oxytocin administration on~     implicit preferences for drug-related and social stimuli in patients receiving MMT.~      Hypothesis 1: Patients will perform better on measures of social cognition (including affect~     recognition and recognition of sarcasm) after administration of oxytocin compared with~     placebo.~      Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective~     effects of methadone after administration of oxytocin compared with placebo.~      Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli~     and decreased implicit preferences for drug related stimuli after administration of oxytocin~     compared with placebo.~   "
101474|NCT01728896|"~     The first step in treating patients with acute pancreatitis is to provide pain relief and~     intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel~     better food and fluids by mouth are restarted. This is done to rest the pancreas which is~     the organ that has been inflamed.~      In some patients when food by mouth restarts they have pain and as a consequence they have a~     longer stay in hospital. It is thought that patients who have little pain and are within 24~     hours of admission to hospital do well if they control their own food intake. This is in~     contrast to the usual treatment where the treating team advise when eating should restart.~   "
101475|NCT01728883|"~     The purpose of this study is to determine the effect of enhancements to the myVisionTrack®~     in regards to patient compliance and test-retest variability. Additionally, the ability of~     myVisionTrack® to detect changes in vision function will be evaluated.~   "
101476|NCT01728870|"~     The purpose of this study is to assess the efficacy and tolerability of a novel dietary~     intervention for early CD based on partial enteral nutrition, and to compare it to the gold~     standard but difficult to implement dietary intervention- Exclusive enteral nutrition with~     Modulen .~   "
101477|NCT01728857|"~     Evaluate the effects of tissue optimization before and during cryolipolysis procedures on~     the outcome of non-invasive fat reduction using the ZELTIQ System.~   "
101478|NCT01728831|"~     This proposal aims to provide some objective, non-invasively achieved, physiologically~     relevant data in order to provide some rational basis for decision-making for transfusion in~     sTBI. Specifically this proposal is an observational study of transfusion and brain tissue~     saturation in sTBI patients. The results will illustrate to what degree brain tissue~     oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision~     of whether transfusion might be helpful.~   "
101479|NCT01728818|"~     Single-agent gemcitabine is currently still regarded as one international standard of care~     for patients with advanced pancreatic cancer (Burris 1997 [4]). The oral EGFR tyrosine~     kinase inhibitor erlotinib received EMEA-approval for the treatment of patients with~     metastatic pancreatic cancer in January 2007.~      In the pivotal phase III trial, the combination of gemcitabine plus erlotinib was associated~     with a statistically significant prolongation of OS (compared to single-agent gemcitabine),~     however, the absolute survival benefit was - for the overall study population - clinically~     moderate (median OS: 6.24 vs 5.91 months, 1-year OS rate: 23% vs 17%; HR = 0.82, p=0.038)~     (Moore 2007 [19]).~      The recently presented FOLFIRINOX regimen shows enhanced activity in metastatic pancreatic~     cancer patients. This regimen is, however, limited to patients with good performance status~     (ECOG 0-1), no major comorbidity, age <75 years, and bilirubin <1.5 ULN (Conroy 2011 [6]).~     The majority of pancreatic cancer patients will therefore not be treated with this regimen.~      Accordingly, novel treatment concepts are urgently needed in pancreatic cancer and~     pre-clinical data indicate an important role of the EGFR1/erbB2 receptor signalling in the~     pathogenesis of pancreatic adenocarcinoma (Yeh 2007 [24]). A recent publication (Larbouret~     2010 [16]) indicates that the combination of cetuximab and trastuzumab induced superior~     antitumour activity in human pancreatic carcinoma xenografts compared to gemcitabine alone~     (see also Larbouret 2007 [15]). Furthermore, synergistic antitumour activity was observed~     when monoclonal antibodies directed against the EGFR1 and erbB2 were combined (Ben-Kasus~     2009 [3]). Based on these data, there is a good rationale to further investigate the~     combined inhibition of the erbB family in pancreatic cancer patients.~      Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is~     applied orally. The purpose of the present trial is to investigate the erbB family~     inhibition by afatinib in patients with metastatic pancreatic cancer.~      In the planned trial, afatinib will be applied at the dose (40 mg/day) that was chosen for~     the randomised phase III trial (LUX 5 study) that investigates afatinib plus weekly~     paclitaxel (80mg/m2).~      Presently there is also a phase I study ongoing that investigates the combination of~     afatinib with gemcitabine (ClinicalTrials.gov Identifier: NCT01251653 U10-2249-02 ).~     Possibly the data will be available once the study is ready to start. Otherwise a~     modification of the regimen will be planned once the respective data will be available.~      In this trial, we integrate a translational project which may allow the identification of~     patients that primarily benefit from this novel treatment approach. The availability of~     tumour tissue- and blood samples from each patient is therefore an important inclusion~     criterion.~      A 2:1 randomisation is chosen favouring the experimental arm since a large body of data is~     available on gemcitabine alone and since sufficient efficacy and toxicity data shall be~     gained in the experimental arm. In addition, the patients' motivation to take part in the~     trial will be greatly enhanced by a greater chance to receive the experimental agent.~   "
101480|NCT01728805|"~     The purpose of this study is to compare the progression free survival of KW-0761 versus~     vorinostat for subjects with relapsed or refractory CTCL.~   "
101481|NCT01728792|"~     This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine~     Candidate (TDV) previously referred to as DENVax of various dosing schedules via~     subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free~     injector (PharmaJet Stratis™).~   "
101482|NCT01728779|"~     Patients with metastatic lesions of the lung, liver, or bone will be candidates for~     treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion~     site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral~     therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same~     Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~   "
101483|NCT01728766|"~     Data collected from this study will provide information on the breast milk zinc~     concentration, maternal and infant zinc status, and transfer of zinc from mothers breast~     milk to infants during first six months of life.~   "
101484|NCT01728753|"~     This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age~     diagnosed with uncomplicated influenza.~   "
101485|NCT01728740|"~     To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose~     combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).~   "
101505|NCT01728480|"~     This phase I trial studies the side effects and best dose of entolimod in treating patients~     with stage III-IV or recurrent head and neck cancer. Biological therapies, such as~     entolimod, may stimulate the immune system in different ways and stop tumor cells from~     growing. Entolimod may also prevent side effects caused by chemotherapy with cisplatin and~     radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used~     in chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving entolimod~     together with cisplatin and radiation therapy may kill more tumor cells~   "
101486|NCT01728727|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end~     stage liver disease. However, lack of donors, surgical complications, rejection, and high~     cost are serious problems.~      Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate~     into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical~     cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater~     overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived~     from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose~     homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver~     cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety~     and efficacy of hUC-MSC treatment for these patients.~   "
101487|NCT01728714|"~     Prospective study to evaluate the impact of an educational programme about diabetes,~     comparing to normal clinical practice, on treatment compliance and disease control of people~     with type 2 diabetes followed in the primary care units in Portugal.~   "
101488|NCT01728701|"~     The purpose of the study is to determine the safety and tolerability of ID administration of~     PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called~     PfSPZ-CVac).~   "
101489|NCT01728688|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end~     stage liver disease. However, lack of donors, surgical complications, rejection, and high~     cost are serious problems.~      In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from~     patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and~     autologous PBSC transplantation can significantly improve liver synthetic function. But~     further studied was needed to confirm the safety and efficacy of PBSC transplantation. In~     this study, a prospective, randomized, parallel clinical study was designed. The patients~     with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via~     hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for~     these patients.~   "
101490|NCT01728675|"~     The purpose of the present investigation is to compare the responses and adaptations of~     young and elderly individuals to repeated eccentric exercise in regards to muscle function~     and redox homeostasis in a side-by-side comparison.~   "
101491|NCT01728662|"~     This study will test that hypothesis that endoscopic lung volume reduction therapy performed~     using emphysematous lung sealant treatment can be improved using smaller doses delivered to~     more a larger number of treatment sites.~   "
101492|NCT01728649|"~     The purpose of this study is to determine whether reducing a patients body temperature (mild~     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury~     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a~     significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).This will be achieved by comparing patients that have undergone~     hypothermia to those that have not.~   "
101493|NCT01728636|"~     The purpose of this study is to determine if tranexamic acid reduces perioperative blood~     loss and red blood cell transfusion during high risk spine surgery.~   "
101494|NCT01728623|"~     This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally~     administered once daily (QD) in subjects with advanced thyroid cancer.~   "
101495|NCT01728610|"~     The purpose of this study is to analyse the effect of a probiotic supplement on functional~     intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).~   "
101496|NCT01728597|"~     One of the main problems in cardiac magnetic resonance (MR) investigations is the strong~     dependence of the achieved image quality on optimal settings of sequence parameters and~     anatomical and physiological situations and it is well known that the diagnostic impact of~     cardiac MR investigations crucially depends on the adaption of imaging protocols to~     patients' state and ability to cooperate.~      The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3~     Tesla cardiac MR investigation protocols without application of contrast agent as well as~     the acquisition of normal values for new cardiac MR images techniques:~        -  normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of~          normal values of magnetic relaxation times (sequence- and protocol dependent),~        -  normal cardiac function: systolic and diastolic function (sequence- and protocol~          dependent),~        -  coronary artery imaging: feasibility to evaluate length, diameter and blood flow~          (sequence- and protocol dependent),~        -  normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D~          blood flow imaging and evaluation techniques (sequence- and protocol dependent).~   "
101497|NCT01728584|"~     The purpose of this pilot study is to compare the use of deep or standard neuromuscular~     blockade (NMB) in combination with low or standard insufflation pressure in participants~     undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the~     injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow~     visualization of and access to the surgical field. The primary hypothesis of the study is~     that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical~     conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the~     participant remains hospitalized for at least 48 hours following the surgery (or at least 24~     hours following the surgery, if local practice does not allow 48 hours of hospitalization~     post surgery). On Day 8, a follow-up visit/contact including all participants occurs.~   "
101498|NCT01728571|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses.~      This ancillary study is being conducted among participants in VITAL and will examine whether~     vitamin D or fish oil improves respiratory symptoms or reduces the risk of lung infections~     or reduces the decline of pulmonary function.~   "
101499|NCT01728558|"~     The Use of sedative drugs in intensive care is widespread. A cohort study conducted in~     Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the~     first 48 hours of mechanical ventilation which was independently linked to prolonged~     ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of~     lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009)~     supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens~     ventilation time and attenuates delirium when compared to midazolam and propofol.~      The investigators confirmed in a pilot study the feasibility, efficacy and safety of a~     process of care known as Early Goal Directed Sedation (EGDS) that delivers:~        1. Early randomization after intubation or arrival in the ICU (intubated).~        2. Early Adequate analgesia after randomization.~        3. Goal directed sedation titrated to achieve light sedation.~        4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of~          benzodiazepines.~      The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when~     compared to standard care sedation in critically ill patients.~      The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care~     sedation, reduces 90-day all-cause mortality in critically ill patients who require~     mechanical ventilation.~   "
101500|NCT01728545|"~     The goal of this study is to collect blood samples from the umbilical cords of newborn~     babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord~     Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is~     part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported~     program to assist in the collection of cord blood. Cord blood will be made available to~     patients through The National Marrow Donor Program (NMDP). These samples may then be offered~     to MD Anderson and other institutions for patients who need a bone marrow transplant and do~     not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood~     units to these institutions around the world according to established bone marrow transplant~     donor criteria, for a fee to cover costs.~      Cord blood samples that are collected and then do not meet the clinical requirements for~     patient use may also be used at MD Anderson or other institutions either for research or for~     quality purposes to improve cord blood banking procedures. If not suitable for patient use~     or for research purposes, the cord blood unit may be thrown away.~   "
101501|NCT01728532|"~     TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical~     tolerance of PA0903 as root canal sealer~      SPONSOR:~      SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33~     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91~      Reference protocol: 11/001~      PRODUCT NAME: PA0903~      MEDICAL DEVICE:~      Class III: Root canal sealer Dose: not applicable Application : one single time~      DEVELOPMENTAL PHASE: not applicable (medical device class III)~   "
101502|NCT01728519|"~     Birch pollen allergic patients are currently treated by subcutaneous injections of pollen~     extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush~     immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital~     environment due to the risk of potential anaphylactic reactions. The aim of this study is to~     test the new product AllerT expected to show widely reduced side effects. AllerT will be~     injected via two different routes, subcutaneous versus intradermal. The primary endpoint of~     the study is the local and systemic safety of repeated injections of the product. Since~     AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic~     symptoms, we will also evaluate the potential efficacy of the approach using a nasal~     provocation test (NPT) with birch pollen~   "
101503|NCT01728506|"~     The purpose of this study is to test the effectiveness of a behavioral weight loss and~     exercise intervention delivered via the internet at different cancer centers in New England.~     The investigators hypothesize that participants will lose 7% of their body weight. The~     research is being done because many women who are treated for breast cancer are overweight~     and treatment for breast cancer is often accompanied by weight gain. Individuals who are~     overweight may be more likely to have their breast cancer come back. Also women who exercise~     at least three hours a week seem to have less chance of their cancer coming back. The~     investigators hope to identify an effective weight loss and exercise intervention for breast~     cancer survivors that can be easily accessed by many people.~      This study is designed to determine the feasibility of conducting a distantly~     delivered-weight loss and exercise intervention for patients who have been treated for~     breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based~     behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer~     survivors in three New England locations.~      Participants will be recruited from three New England Cancer Centers - the Vermont Cancer~     Center, Norris Cotton Cancer Center at Dartmouth University and the University of~     Massachusetts Cancer Center. Participants from each center will undergo baseline assessments~     that include diet assessment, body measurements (height, weight, etc), a physical activity~     assessment and be asked to complete a series of questionnaires.~      Patients that meet the minimum requirements will be enrolled on the study. They will~     participate in weekly on-line chats about behavioral and diet modifications led by a~     qualified facilitator. Participants will also engage in increasing amounts of aerobic~     activity (typically walking) throughout the course of the intervention. The intervention~     lasts 6 months. At the end of those 6 months, participants will have the same assessments~     that were collected at baseline. Following the collection of those assessments, participants~     will have completed the study.~   "
101504|NCT01728493|"~     Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused~     by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99%~     predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal~     hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:~        1. independent of the level of blood pressure, hypertension due to autonomous aldosterone~          secretion causes more cardiovascular damage than essential hypertension;~        2. PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid~          receptor antagonists (MRA) in case of BAH.~      Although previously presumed a rare condition (prevalence <1%), PA is now estimated to~     affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as~     the amount of cardiovascular damage and the available specific treatment, the question is~     raised whether screening of PA should be introduced in Dutch general practice. To answer~     this important question, several issues with regard to PA need to be elucidated:~        1. International studies report a prevalence of PA in general practice of 6-13%.~          Prevalence in the Dutch population is still unknown;~        2. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of~          hypertension (mean eight years), data on characteristics of early diagnosed PA are~          lacking. Proof of early cardiovascular damage would strengthen the case of screening~          for PA and needs to be studied;~        3. Consequently, the diagnostic delay has lead to lack of data on optimal treatment in~          early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a~          regimen of antihypertensive drugs is advised, and only if hypertension is refractory~          for >6 months patients are referred. It is unknown if hypertension is resistant to~          therapy in the initial phase of PA. If not, this would also argue for early biochemical~          screening for PA, because even if blood pressure is controlled, the detrimental effect~          of aldosterone itself will go on unopposed. It is therefore required to study the~          response to antihypertensive drugs (not MRA) in these patients.~   "
101506|NCT01728467|"~     This study builds on data that high-density lipoprotein (HDL) has a number of potentially~     beneficial effects including directly modulating glucose metabolism through multiple~     mechanisms. The primary objective of this study is to determine the effects of RVX000222 on~     postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or~     impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test~     (OGTT).~   "
101511|NCT01728402|"~     The cause of blood and bone marrow cancers is poorly understood; however, most research~     focuses on how cancer cells grow and develop. Because the causes of these cancers are~     unknown, current treatments may be unnecessarily harsh and often do not provide a cure.~     Identifying the causes of blood cancers would allow for the development of treatments that~     are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we~     will look for specific cancer cell abnormalities that are responsible for cancer cell~     growth. We will then look to see if drugs that can reverse these abnormalities can kill~     cancer cells.~   "
101512|NCT01728389|"~     The purpose of the study is to evaluate efficacy and safety of direct intrabone~     transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched~     sibling donors in patients with myeloid and lymphoid malignancies.~   "
101513|NCT01728376|"~     The intent of this study is to describe the safety and efficacy of daptomycin versus~     standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by~     Staphylococcus aureus (S. aureus).~   "
101514|NCT01728363|"~     Multiple center, open-label, PK study~   "
101515|NCT01728350|"~     The purpose of this project is to determine if participating in volunteer activity improves~     the psychological well-being of individuals with traumatic brain injury (TBI).~   "
101516|NCT01728337|"~     this study was proposed to provide more scientific and objective data on the clinical and~     aesthetic effects of these two toxins (Dysport and Xeomin).~   "
101517|NCT01728324|"~     The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI~     207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically~     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.~   "
101518|NCT01728311|"~     The purpose of this study is to determine the safety, tolerability and the pharmacokinetics~     of BAY1082439~   "
101519|NCT01728298|"~     The primary objective of the trial is to evaluate the dose-response relationship with~     regards to change in immunological parameters and safety for SLITone ULTRA house dust mite~     mix in adult subjects with moderate to severe HDM allergic rhinitis.~   "
101520|NCT01728285|"~     Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic~     diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment~     of allergic rhinitis, which has to be taken daily by patients. This study was aimed to~     establish if a device with the characteristics of a mechanical dispenser (Memozax®) could~     improve adherence to treatment in subjects with hay fever due to allergy to grass~   "
101521|NCT01728272|"~     Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the~     absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump~     surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.~   "
101522|NCT01728259|"~     This phase I trial studies the side effects and best dose of pomalidomide and bortezomib~     when given together with dexamethasone in treating patients with amyloid light-chain~     amyloidosis or light chain deposition disease. Biological therapies, such as pomalidomide,~     may stimulate the immune system in different ways and stop abnormal cells from growing.~     Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for~     cell growth. Giving pomalidomide and bortezomib together with dexamethasone may be an~     effective treatment for amyloid light-chain amyloidosis or light chain deposition disease~   "
101523|NCT01728246|"~     The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life~     (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to~     another medication) in Filipino participants with chronic (lasting a long time)~     osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become~     painful and stiff).~   "
101524|NCT01728233|"~     Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily~     on regional lymph-node involvement. Despite the fact that cure can be obtained in patients~     with low metastatic load (pN1) by monotherapy, combination therapy is required for more~     advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not~     very effective so far and the few chances for cure are solely dependent on multimodality~     treatment, either with surgery or radiation. Based on the observation that the epidermal~     growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming~     similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been~     investigated with promising early results at Istituto Tumori Milan and University of Texas~     MD Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor~     dacomitinib for advanced or metastatic penile SCC.~   "
101525|NCT01728220|"~     This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming~     clinical study characterizing the pharmacodynamic effects of pulsed iNO using the~     combination product, inhaled nitric oxide/INOpulse DS-C vs. placebo in subjects with World~     Health Organization (WHO) Group 3 pulmonary hypertension (PH) associated with Chronic~     Obstructive Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).~   "
101526|NCT01728207|"~     IMMU-114 will be studied at different dose schedules and dose levels in order to assess the~     highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the~     skin). IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest.~     This is considered one cycle. Treatment cycles will be repeated until toxicity or worsening~     of disease.~   "
101527|NCT01728194|"~     This study may help identify how abnormalities in brain systems that control the ability to~     ignore irrelevant information may contribute to the development of depression in older~     adults.~   "
101555|NCT01727830|"~     Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution~     with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate~     reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination~     of FBG and FXIII.~      In blood of 12 volunteers the following measurements are performed at baseline and 60%~     dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation~     factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational~     thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in~     concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements~     and determination of factor concentrations are again performed.~        -  Trial with medical device~   "
101528|NCT01728181|"~     The current trial A Phase I/II study of Erlotinib +/- Tivozanib as initial treatment for~     Metastatic Non-small Cell Lung Cancer assigned by VeriStrat® Serum Proteomic Evaluation~     will begin by evaluating toxicity for the combination of Tivozanib and Erlotinib to~     determine a phase II dose. The phase II portion of the study will seek to duplicate the~     finding of the BEER trial in a selected population of patients with NSCLC with a VeriStrat®~     Good signature using two oral agents with Tivozanib substituted for bevacizumab. Phase II~     will be designed as a selection-based randomized trial. Patients with VeriStrat® Good~     signature will be assigned to EGFR inhibitor therapy with a randomization to Erlotinib~     plus/minus Tivozanib. Patients with VeriStrat® Poor signature will be assigned to standard~     of care. Standard-of-care chemotherapy as first treatment at the discretion of patient and~     physician will be evaluated for response to treatment, survival and repeat VeriStrat®~     signature.~   "
101529|NCT01728168|"~     The objective of the study is to assess the prevalence of a sensitization to proteins from~     legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material~     (lupin) in atopic and healthy subjects.~   "
101530|NCT01728155|"~     The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study),~     groups together in a single protocol the treatment of all patients with non high risk~     neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk.~     These two separate cohorts are included in one single protocol to enable patient data from~     these two groups to be entered into a common database, as the current prognostic~     classifications determining treatment may evolve further with subsequent more detailed~     molecular analysis of the tumours.~      1. LOW RISK STUDY~      The Low Risk Study is proposed in order to:~        -  minimise the amount of treatment (chemotherapy and surgery) for all appropriate low~          risk patients, who in previous studies have been shown to have an excellent long-term~          outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall~          survival was greater than 97%(H. Rubie, JCO).~        -  improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a~          SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental~          chromosomal change (SCA)) by electively treating these patients with chemotherapy~          despite the absence of symptoms.~           2) INTERMEDIATE RISK STUDY~      The Intermediate Risk Study is proposed in order to:~        -  reduce the amount of chemotherapy for differentiating histology INRG (International~          Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in~          previous SIOPEN study have been shown to have an excellent long-term outcome;~        -  increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for~          poorly differentiated or undifferentiated histology INRG stage L2 NB or~          ganglioneuroblastoma nodular patients in order to improve the EFS registered in the~          previous SIOPEN study;~        -  improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related~          oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1~          NB patients with the introduction of adjuvant treatment;~        -  maintain the very good results obtained in previous SIOPEN study for INRG stage M~          infants with a moderate treatment.~      NEONATAL SUPRARENAL MASSES~      The incidence of suprarenal tumours/masses has increased in the last decade due to the~     expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and~     early infancy care. The differential diagnosis of these masses ranges from benign (adrenal~     haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on~     perinatal suprarenal masses, although based on a relatively large literature, is scattered~     amongst studies on very few cases with no methodical approach and often short follow up.~     Therefore, the optimal management of these masses has not been clearly defined.~     Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases.~     The SIOPEN Group, based on their results in the first multicenter European Trial for infants~     with neuroblastoma (INES) and the world-wide experience provided in the literature, is~     launching this European surveillance study (Multi-centre, non-blinded, one armed prospective~     trial) for these masses. Treatment: Observation~   "
101531|NCT01728142|"~     The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,~     portable, and field-hardened NeuroCognitive Assessment Tool. The purpose of this study is~     to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological~     Assessment Metrics (ANAM) battery currently used by the military after concussion. The~     primary hypothesis is that the DANA Brief exam will be more sensitive for detecting~     continued impaired cognitive performance than the ANAM during recovery after a concussion.~   "
101532|NCT01728129|"~     The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE~     cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive~     for detecting impaired cognitive performance than the MACE cognitive score in the setting of~     a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary~     purpose of this study is to examine a serial performance on the DANA Rapid exam in those~     subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam~     will show improvements in performance during the recovery period after concussion.~   "
101533|NCT01728116|"~     To determine if the EndoBarrier safely and effectively improves glycemic control in obese~     subjects with type 2 diabetes~   "
101534|NCT01728103|"~     The objective of this study is to obtain female first-catch urine, vaginal, cervical and~     endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and~     TIGRIS® Systems.~   "
101535|NCT01728090|"~     The aim of the study was to assess the effectiveness of a hand-washing programme using hand~     sanitizer in the prevention of school absenteeism due to upper respiratory infections.~     Students in intervention classrooms used hand sanitizers at schools and a programme~     educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers~     in elementary school will reduce absenteeism due to upper respiratory infections.~   "
101536|NCT01728077|"~     N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of~     Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life~     and to explore the direct medical resource use for BRV (for subjects entering N01372 from a~     study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of~     200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.~   "
101537|NCT01728064|"~     The purpose of this study is to examine the effects of EPI-743 on visual function and~     neurologic function in patients with Friedreich's ataxia.~   "
101538|NCT01728051|"~     The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted~     in the same patient population as well as using the same melphalan dosing as proposed in~     this study. This expanded access protocol will provide an experimental alternative treatment~     option for both physicians and patients until the Delcath CS-PHP System receives marketing~     approval.~   "
101539|NCT01728038|"~     An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED)~     annually. Up to 50% of these parental smokers are from low-income, racially/ethnically~     diverse households in which a variety of tobacco-related disparities (TRD) exist for both~     the parents and their children. The PED is an ideal setting in which to address these~     disparities, which include differences in tobacco use, pediatric second hand smoke exposure~     (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team~     has conducted the only two small-scale randomized control trials (RCTs) investigating the~     efficacy of providing smoking cessation counseling to parents in the PED setting. This~     previous research indicates that parental smokers who visit the PED are aware of the~     pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this~     setting, and show trends towards quitting.~      Parents with children who have a SHSe-related illness will have higher prolonged abstinence~     and point prevalence cessation rates, higher motivation to quit, greater number of quit~     attempts, and lower child SHSe compared to those parents who have a child with a~     non-SHSe-related illness at baseline.~   "
101540|NCT01728025|"~     The purpose of this study is to determine whether ranolazine will reduce the risk of~     arrhythmic events in patients with long QT syndrome type 3.~   "
101541|NCT01728012|"~     Mineral metabolism disturbances occur early during the course of chronic kidney disease and~     eventually affect most patients. For how long such disturbances persist after a successful~     renal transplantation is mainly unknown. This study will investigate the prevalence of such~     disturbances in patients more than 10 years following a successful renal transplantation.~     The patients will be recruited from an existing registry in Norway.~   "
101556|NCT01727817|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of~     a hospital based clinical research center.~   "
101557|NCT01727804|"~     The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without~     fluoride, in prevention of occlusal caries in the primary dentition.~   "
101710|NCT01725776|"~     The purpose of this study is to investigate the concentration-effect relationship of inhaled~     milrinone after prophylactic administration in cardiac surgical patients with preoperative~     pulmonary hypertension undergoing cardiopulmonary bypass.~   "
101542|NCT01727999|"~     Introduction:~      Ineffective platelet production has been proven to play a role in the etiology of Immune~     Thrombocytopenia (ITP) in addition to increased platelet destruction. The second-generation~     thrombopoietin (TPO) mimetics have shown good efficacy in boosting platelet counts in the~     great majority of patients with chronic ITP in several clinical trials.1, 2 Nevertheless,~     about 20% of patients with ITP fail to respond to the TPO mimetic treatment. Those~     treatment-resistant patients are un-characterized and the reasons for the lack of response~     have not been studied. The identification of predictive blood biomarkers of patients'~     response to treatment will be useful in reducing both cost and potential side effects; and~     it will be of equal importance and interest to investigate the molecular mechanisms~     underlying the patients' heterogeneous responses to TPO mimetic treatment.~      Specific Aims:~        1. To identify blood classifier genes which correlate with patients' response to TPO~          mimetic treatment.~        2. To compare the blood gene expression changes in responders and non-responders after TPO~          mimetic treatment and explore the possible molecular mechanisms accounting for the~          non-responsiveness to the treatment.~   "
101543|NCT01727986|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical~     response to RoActemra/Actemra in the core study will be eligible to receive~     RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment~     is 104 weeks.~   "
101544|NCT01727973|"~     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50~     mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy~     (GO).~   "
101545|NCT01727960|"~     Neck and shoulder pain (NSP) is fairly common among high school students in Korea.~     Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an~     inappropriate static position for a prolonged period of time. We suspect that proper~     education and posture correction for Korean adolescents may decrease the prevalence or~     severity of NSP. Although several studies have focused on the etiology of NSP during~     adolescence, few studies have addressed the management or prevention of NSP in adolescents,~     despite its high prevalence in this age group. The aims of this prospective study was to~     identify the effects of education, in terms of recognition of this issue and posture~     correction, on prevalence and severity of NSP in Korean adolescents~   "
101546|NCT01727947|"~     Current research on sperm morphology has been directed towards the dysmorphisms of the sperm~     head. A new technique based on the motile sperm organelle morphology examination (MSOME)~     allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are~     specific sperm alterations observed under high magnification, and their presence has been~     related to increased DNA fragmentation and denaturation.~   "
101547|NCT01727934|"~     The purpose of this open-label study is to assess the safety, antiviral activity, and~     pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over~     5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of~     12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV~     genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.~   "
101548|NCT01727921|"~     Background:~      EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with~     pancreatic mass with high specificity, specificity and accuracy. However FNA with small~     needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this~     limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore~     needles were frequently used. However there was no comparative study of the efficacy and~     accuracy between 22 and 25 gauge ProCore needle yet.~      Aim:~      To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore~     needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not~     inferior to 22 gauge ProCore needle.)~   "
101549|NCT01727908|"~     The purpose of this study is to determine whether staining of the gastric mucosa increases~     the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in~     first degree relatives of individuals with familial gastric cancer.~   "
101550|NCT01727895|"~     The purpose of this study is to test wether orally administered Beta-glucan has systemic~     effects in humans.~   "
101551|NCT01727882|"~     The purpose of this study is to investigate whether automated telephony may be used for~     daily assessments of paroled offenders, and whether a brief intervention based on these~     daily assessments may result in a more positive development compared to daily assessments~     only.~   "
101552|NCT01727869|"~     This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in~     combination with erlotinib or cetuximab administered to patients with certain types of~     cancer.~   "
101553|NCT01727856|"~     Rehabilitation exercise conducted at home following injury improves clinical and functional~     outcomes. Optimum compliance with prescribed exercise regimens requires regular patient~     instruction, performance assessment, monitoring and general encouragement from healthcare~     staff. Exercise at home though convenient for patients is not conducive for provision of the~     professional support needed to maximize prescribed regimen effectiveness.~      Software in development by Reflexion Health Inc. along with the Naval Medical Center San~     Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during~     at-home rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware~     platform for the designed software package tentatively called, Reflexion. Kinect® contains~     a marker-less/controller-less motion tracking camera. The final Reflexion software will rely~     on a Rehabilitation Measurement Tool (RMT) to detect cardinal plane skeletal joint~     movement and its velocity utilizing the embedded Kinect® camera while also providing patient~     visual feedback via an avatar on a television screen.~      In this observational minimal risk study, RMT/Kinect® functional reliability and usability~     will be assessed. Twenty healthy subjects will physically set-up and turn-on the~     hardware/software system; receive exercise directions from the RMT; then conduct a series of~     knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair.~      An initial limited data set, obtained by Reflexion Health, provided validity and reliability~     measures. Eighteen degrees of absolute difference was detected between manual goniometry and~     Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise.~     Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A~     correctable systematic bias toward underestimation by the RMT will allow for future more~     accurate estimations of joint positioning improving face validity.~      RMT functional reliability and general usability will be expressed in this study utilizing~     descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect®~     camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software~     errors and failure will tallied and measured to ascertain RMT reliability.~      User-RMT interaction quality will be evaluated with video recordings of each set-up and~     exercise session. Specifically, usability measures will include: need for additional~     assistance setting-up or operating the RMT; number of attempts required by the subject to~     interact with a specific feature: time spent on specific elements during the session.~     Participant feedback will be elicited post-session using two scaled questionnaires: System~     Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide~     software modifications needed prior to implementation of future clinical studies within the~     NMCSD population.~   "
101554|NCT01727843|"~     Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of~     fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple~     studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty.~     However, concerns about the prothrombotic side effects of systemic administration of TA has~     hindered the widespread adoption of this medication in orthopaedic patients due to their~     high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism~     Topical application of tranexamic acid has been proposed as a way to mitigate the potential~     prothrombotic effects of TA. Topical application of TA has been demonstrated to be~     beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal~     following topical application, minimizing its potential systemic thromboembolic side~     effects. TA has been used topically in total knee arthroplasty, with significant reductions~     in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in~     hip fracture surgery is limited, and there are no studies examining topical use of TA in hip~     fracture surgery. Our study question is: Does topical tranexamic acid decrease blood loss~     following hemiarthroplasty of the hip for femoral neck fractures?~   "
101558|NCT01727791|"~     This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in~     healthy lactating women. The objectives are to determine whether pregabalin is secreted in~     breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other~     objectives are to estimate potential infant exposure to pregabalin if administered to~     lactating women and to characterize the safety and tolerability of pregabalin in lactating~     women.~   "
101559|NCT01727778|"~     Primary~      - To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.)~     infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma.~      Secondary~        -  To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein,~          serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin,~          C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies.~        -  To evaluate the duration of response and the progression free survival.~   "
101560|NCT01727765|"~     This is a pilot study which will assess the feasibility of a follow on main study. This~     study will examine the impact of inspiratory muscle training on quality of life, rescue drug~     medication usage, and other markers of asthma in adult asthmatics in the UK.~   "
101561|NCT01727752|"~     A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous~     Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication~     caused by Lumbar Stenosis~   "
101562|NCT01727739|"~     Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings~     autograft may contribute to failure of the graft and/or present technical challenges~     secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be~     made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing~     the biomechanical properties of the graft construct. The purpose of this investigation is to~     examine the tibial tunnel widening relationship between bioabsorbable interference screws~     composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws~     composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized~     as tibial fixation devices.~      Specifically the study has the following objectives: 1) To quantify the extent of tibial~     tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous~     quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium~     phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel~     widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation~     devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is~     hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with~     a reduction in tibial tunnel widening around the implant but rather between the implant and~     articular surface, compared to the PLLA alone screw. It is also hypothesized that there will~     be no effect of observed tunnel widening on clinical outcomes or graft failure rates.~   "
101563|NCT01727726|"~     To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy~     to an assigned open label antidepressant therapy (ADT) in the proposed subject population~     with MDD.~   "
101564|NCT01727713|"~     The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing~     Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
101565|NCT01727700|"~     The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole~     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
101566|NCT01727687|"~     As society ages, a large amount of human factors related research has been carried out into~     the subject of the safety of the elderly in their daily lives. However, most research~     focuses on the general elderly population and there is a serious lack of research into~     elderly sufferers of Parkinson's disease (PD), who receive a substantial amount of attention~     in medical circles. In the investigators previous study, the investigators have found that~     patient with PD had decreased ability to cross the road as compared to age/gender matched~     control subjects. Hence, this research proposed several training programs to enhance the~     safety of crossing road, including safe place finding，roadside search，time gap and~     perception of other's intentions. The investigators will compare the parameters of crossing~     road ability before and after training programs in patients with PD and control subjects.~      The results of this research will clarify the correlation between medical scale test~     indicators and movement safety for patients with PD. The effects of training programs will~     be provided for further safety management and design concepts to improve the lives of this~     disease group.~   "
101567|NCT01727674|"~     According to the statistics released by the Department of Health,Executive Yuan in~     2005,depression, cancer and AIDS will become the three main diseases of the 21st century.The~     prevalence of depression is 5.8% for males and 9.5% for women in the worldwide total~     population each year.Depression ranks second next to cardiovascular disease and impacts on~     social and economic burdens.From the perspectives of prevalence,suicide rate,loss of~     workforce,family burden,co-morbidities and health care expenses,the issues related to caring~     for patients with depression should not be overlooked.Communication is often neglected while~     exploring the issues of caring for depressed patients,which can consequently affect their~     family,work performance,social interaction,and even leads to a risk of suicide.Therefore,in~     order to enhance their psychological adjustment and health management,it is particularly~     important to achieve effective communications.~   "
101568|NCT01727661|"~     The purpose of this study is to compare the differences of~        1. cardiopulmonary fitness~        2. lung function~        3. muscular oxygen saturation~        4. quality of life between type 1 diabetes mellitus and healthy adults.~   "
101569|NCT01727648|"~     The findings of this project will contribute to the understanding of a comprehensive probe~     for investigation of the effects of monotherapy versus combination rehabilitation~     intervention after stroke, including the topics of possible underlying mechanisms of motor~     recovery as well as the beneficial and adverse effects of intense rehabilitation therapy,~     prognostic factors of the outcomes, and clinimetric properties of the instruments. The~     overall findings of this project will be significant in the era of knowledge translation and~     guide the development of innovative and effective interventions for individualized stroke~     rehabilitation.~   "
101577|NCT01727544|"~     The primary objective of this study is to measure objective, functional outcomes of patients~     undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.~   "
101578|NCT01727531|"~     This research is being done to determine if a short course of Chloroquine (five weeks)~     before, during and after whole brain radiation therapy (WBRT) will improve the overall~     survival of subjects being treated for brain metastases.~   "
101579|NCT01727518|"~     The Austrian LEAD study is the first investigation initiated in Austria that aims to~     investigate the prevalence and the natural history of COPD in a reference population of~     Austria.~   "
101570|NCT01727635|"~     Aims and objectives: This study aims to examine the effects of the body-mind-spirit group~     therapy on marital close relationships, sleeping quality, depression, quality of life,~     meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and~     partners.~      Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast~     cancer survivors will be recruited from outpatient department of surgical at hospital. The~     partners will be invited to participate in this study through the survivors. The 120 dyad~     survivors and spouse will be randomly assigned into an experimental group or a control~     group. Survivors and spouse partners in an experimental group will receive 2 months time~     body-mind-spirit group therapy while those in a control will receive usual care in the same~     period of time. The outcome measures include Experiences in close relationships scale, Moss~     sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life~     questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points~     include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12~     months after the end of intervention for the maintenance effect. Univariate analyses will be~     performed to explore the basic characteristics of participants. The hierarchical linear~     model will be used to test the hypothesis the improvement is higher in intervention group~     than the control group in the effects of marital close relationships, sleeping quality,~     depression, meaning of life, quality of life, and salivary cortisol levels in metastatic~     breast cancer survivors and partners.~   "
101571|NCT01727622|"~     The purpose of this study is to determine the value of Arterial Spin Labeling (ASL) MRI, a~     measure of blood flow to the brain, in Mild Cognitive Impairment (MCI) and compare it to~     existing measures. In particular, the investigators will compare ASL MRI to Positron~     Emission Tomography (PET/CT), which measures brain metabolism reflecting how well cells in a~     patient's brain are functioning. In addition, the investigators will assess the relationship~     of these measures to specific protein levels associated with Alzheimer's Disease in the~     patient's cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) obtained~     by lumbar puncture. By comparing the information that is available from these procedures to~     the patient's performance on cognitive tests, the investigators hope to learn which~     procedures most accurately reflect and assist in determination of the potential causes of~     cognitive difficulties that arise with MCI, and thus, which are most useful in the clinical~     setting. In particular, PET scans have been found to be very useful in diagnosis of MCI and~     Alzheimer's Disease, but the investigators want to find out if they can get the same, or~     better, information from an ASL MRI scan, which is less expensive and easier to acquire.~   "
101572|NCT01727609|"~     Survival of preterm infants has increased greatly over the years, so a major aim now is to~     improve the long term outlook for these babies and to avoid serious complications. The way~     babies are fed in early life affects short and long-term health and survival.~      Because the bowels of preterm infants have not matured, they cannot digest large volumes of~     milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip~     while the amount of milk given is gradually increased over time. Increasing the amount of~     milk rapidly may increase the risk of gut complications. Increasing the amount of milk given~     more slowly means that intravenous nutrition is needed for longer; there is an associated~     risk of infection proportional to the time the intravenous line is present in the~     bloodstream of these infants. Despite the importance of milk feeding preterm infants, there~     have been few studies to inform how best to balance these risks, and what the best way to~     increase feeds in these infants is - this study sets out to address this missing~     information.~      The study will compare two different speeds of milk feed increase, one 'faster' and one~     'slower', both within rates currently used in United Kingdom neonatal units. The study aims~     to find out if either speed of milk feed increase gives better outcomes for the infants.~     Investigators will measure a variety of outcomes, such as survival without disability,~     infection, bowel problems, growth and long-term physical and mental development, as well as~     the impact on families and the National Health Service, including costs.~      The study is being led by an established team of researchers who have run similar studies~     before, and uses an established network of neonatal units that have taken part in previous~     studies.~   "
101573|NCT01727596|"~     Background: Taping has been used for more than 20 years for patellofemoral pain syndrome~     (PFPS) but the effectiveness is still controversial.~      Purpose: This prospective study was conducted to investigate the effect and predictors of~     effectiveness of taping in treating PFPS.~      Study design: Prospective cohort study Methods: One hundred consecutive patients with the~     diagnosis of PFPS were included in the study. Factors including sex, age, body mass index~     (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and~     pre-taping pain score were measured. One well-trained therapist applied adhesive tape to~     each patient by McConnell approach. Before and after taping, patients completed a visual~     analog pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test~     was used for the difference of the VAS score measured before and after taping. Patients with~     improvement of more than 1 point in VAS score after taping were considered responsible, and~     others were non-responsible. The results were analyzed by logistic regression.~   "
101574|NCT01727583|"~     This pilot study is aimed at assessing the acute effect of several combinations of lipids~     differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1~     secretion in healthy subjects.~   "
101575|NCT01727570|"~     To determine the impact of nutritional supplementation with whey protein on postoperative~     functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized~     that, compared with a control group receiving nutrition counselling only, patients receiving~     nutritional counselling along with preoperative and postoperative nutritional supplements~     will have a significantly improved change in functional walking capacity from baseline to 8~     weeks after surgery.~   "
101576|NCT01727557|"~     This study is being done to compare the two anesthesia techniques which are commonly used in~     the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local~     anesthesia means that, your doctor will inject numbing medication directly into the tissue~     or part of your body where the surgery will be done. In this case, the numbing medication~     will be injected directly into the area where your fistula will be made. In regional~     anesthesia, the numbing medication will be injected around the nerve (part of the body that~     gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to~     compare the three month success rates of AV fistulae created by the two anesthesia~     techniques.~   "
101580|NCT01727505|"~     Preterm infants undergoing mechanical ventilation often present with respiratory instability~     which leads to fluctuations in ventilation and oxygenation. In conventional modes of~     mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate~     and a constant peak inspiratory pressure.~      We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated~     preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by~     decrease in tidal volume. This is due to a reduction in respiratory system compliance and~     increase in airway resistance.~      Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the~     exhaled tidal volume of each ventilator breath and automatically adjusts the peak~     inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume~     Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours~     in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease~     the duration of episodes of hypoxemia when compared to conventional mechanical ventilation~     during routine clinical conditions and over longer periods of time.~      The objective of the study is to evaluate the effects of Volume Guarantee on the duration,~     severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants~     who present with frequent hypoxemia episodes in comparison to conventional ventilation over~     two periods of 24 hours each and under routine clinical conditions.~   "
101581|NCT01727492|"~     The current study is a dubble-blinde placebo-controlled cross-over study verifying the~     preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced~     tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein~     which should be taken 1h before leisure noise above 100dB for at least 30 minutes.~   "
101582|NCT01727479|"~     Investigate the acute effect of ribose supplementation on performance and recovery in~     athletes.~   "
101583|NCT01727466|"~     Children with high-functioning autism spectrum disorders (ASD) are at high risk for~     developing significant anxiety symptoms. Cognitive behavior therapies (CBT) are frequently~     used for children with anxiety symptoms with good success. The purpose of the current study~     was to examine the efficacy of a family-focused group CBT program (Facing Your Fears [FYF])~     compared to Treatment As Usual (TAU). Participants were randomized to either active~     treatment or TAU. It was hypothesized that children who completed the active treatment would~     demonstrate improvement in their anxiety symptoms relative to children in TAU.~   "
101584|NCT01727453|"~     SUMMARY~      1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized~     use.~      1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant~     Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.~      1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with~     antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with~     anticoagulation criteria and who have had an episode of gastrointestinal bleeding.~      1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr.~     Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr.~     Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive~     Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant~     Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax:~     (34) 93 291 92 78.~      E-mail: cvillanueva@santpau.es. 1.5. Centers that are planned for the trial: Service~     Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.~      1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor:~     Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret,~     167. 08025 Barcelona. Tel: (34) 93 291 9140.~      1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main~     objective: To compare the incidence of gastrointestinal rebleeding and safety of oral~     anticoagulation versus low molecular weight heparin in patients who have had an acute~     gastrointestinal bleeding and have indication for anticoagulation.~      1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study~     disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration:~     Incidence of gastrointestinal bleeding.~      1.14. Study population and total number of patients: 20 patients were required in each group~     (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and~     10% beta.~      1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 -~     July 2013~   "
101585|NCT01727440|"~     The goal of this study is to enroll 250 participants that have joined the MURDOCK Study~     Horizon 1.5 (Duke IRB Pro00011196) with a current or prior diagnosis of severe acne AND~     current or prior treatment with oral isotretinoin. All 250 participants will answer a 5-page~     questionnaire designed to collect information on the diagnosis of severe acne and response~     to oral isotretinoin treatment. The aim is to identify genetic predictors of severe acne~     vulgaris and the outcome of oral isotretinoin treatment.~   "
101586|NCT01727427|"~     The same initial and long-term anticoagulation is suggested for unsuspected pulmonary~     embolism as for patients with symptomatic embolism. Based on these indications, cancer~     patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months~     or until the disease is active, which in most cases would mean indefinite treatment. In~     fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing,~     leaving doubts over the need for (indefinite) anticoagulation which exposes these patients~     to an increased risk of major bleeding events. Concerns over the need for anticoagulant~     treatment may especially hold for pulmonary embolism of the distal pulmonary tree since~     segmental and sub-segmental PE seem to have a more benign course than more proximal~     embolism.~      The scope of this study is to evaluate the current treatment approaches for unsuspected~     pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of~     cancer patients.~   "
101587|NCT01727414|"~     This study evaluates how children with Attention Deficit Disorder without Hyperactivity~     (ADD) respond to medication, and if their response is different from children who have~     problems with both hyperactivity and inattention. In order to do this, children ages 7-11~     whose primary difficulty is with attention problems and who have never been on behavioral or~     psychiatric medications are being recruited. Once enrolled, children will try one week each~     of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit,~     Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly~     assigned to one of six possible medication dose and placebo titration schedules, but the~     study doctor, family, and teacher will not know which dose (if any) children are receiving~     for a given week. Each week, behavioral and side effect ratings will be completed by both~     the child's parent and teacher, and the family will meet with the study doctor for a~     physical examination and to discuss how each week went. Some children will also have~     neuropsychological testing to determine how methylphenidate influences their working memory,~     sustained attention, and ability to inhibit (stop) inappropriate responses.~      All data will be analyzed to decide which medication dose the child responded to best and~     further recommendations for treatment will be given. Ultimately, this study aims to improve~     understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant~     medications by~        -  determining whether these children experience a diminished response to methylphenidate~          compared to children with both hyperactivity and inattention~        -  determining whether certain genetic and environmental factors play a role in this~          response.~      Findings from this study will be used to help streamline the identification of the most~     effective doses of medication for children with ADHD-Primarily Inattentive Type.~   "
101623|NCT01726920|"~     The purpose of this study is to determine whether a fixed-dose combination of naratriptan~     2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute~     treatment of migraine.~   "
102674|NCT01713166|"~     The purpose of this study is to compare the effects of crystalloid and colloid, which are~     used for pump priming solution, on the microcirculatory alterations during cardiac surgery.~   "
101588|NCT01727401|"~     Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous~     thromboembolism in high risk medical patients. A relevant proportion of these patients have~     renal insufficiency and/or thrombocytopenia which represent independent risk factors for~     bleeding. The risk of bleeding may be increased when fondaparinux is administered to~     patients with a reduced renal function and/or low platelet count. A lower dose of~     fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined~     by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no~     clinical studies that have specifically evaluated prophylaxis with fondaparinux in~     acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this~     study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients~     with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL~     and 30,000/uL.~   "
101589|NCT01727388|"~     Digital rectal examination is an act clinically performed daily by physicians and surgeons.~     It remains the key diagnostic test and directs the therapeutic management of cancer of the~     lower and middle rectum. It can be done in two main positions: lateral decubitus, and~     supine.~      However, no randomized study in colorectal surgery is not interested in evaluating the best~     position to perform a full rectal exam.~   "
101590|NCT01727375|"~     The purpose of this multicenter randomised controlled trial is to investigate if circadian~     light at the patients bedside (using Philips HealWell system, CE marked)significantly~     reduces prevalence of delirium in mechanically ventilated intensive care unit patients.~   "
101591|NCT01727362|"~     The aim of this trial is to investigate the effectiveness of acupuncture on quality of life~     in patients with breast cancer receiving chemotherapy compared to routine care.~   "
101592|NCT01727349|"~     Considering its epidemic-like development worldwide, associated with modifications in~     lifestyle, as well as its enormous social and economic weight, the prevention of type II~     diabetes is certain to be a central concern of health systems within the developed countries~     in the decades to come. However, while simple obesity concerns the entire population, type 2~     diabetes affects only one sub-population at high genetic risk. To be effective and realistic~     in economic terms, efforts at prevention must be thus targeted towards these subjects at~     high risk. The key issue involves identifying such subjects early enough so that a strategy~     of effective prevention can be organized in good time.~      Until now, efforts have been concentrated on individuals at risk for diabetes readily~     identifiable within the general population, typically subjects in the second half of~     adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive~     lifestyle and dietary measures are proposed but are constrictive and difficult to maintain~     over time, and the results, although they may be significant, remain disappointing, with~     mere postponement of an outcome which at this stage appears inevitable. The reason is~     ascribable to excessively tardy intervention, when the pathogenic process has already been~     ongoing for some ten years and the endocrine function of the pancreas is probably already~     irreparably impaired.~      The alternative thus is earlier intervention, in childhood, adolescence or early adulthood.~     The problem is to identify individuals at high risk of becoming diabetic at a time when they~     are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The~     familial character of type 2 diabetes is now well established, and future diabetic subjects~     are themselves above all the children of diabetic subjects. However, the prevalence of the~     disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive~     tools are needed to combat diabetes in these high-risk families.~      We propose to create a risk equation using an algorithm to reliably predict children most~     likely to develop diabetes later in life.~      The algorithm will include 3 classes of data:~        -  The genotype stemming from the genetic characterization of individuals and those their~          parents;~        -  Environmental data concerning childhood, especially eating habits and physical~          activity;~        -  Data of the mother who was eventually diabetic during pregnancy.~      From a methodological standpoint, it would be rather difficult to take blood samples from~     children and wait some 50 years to determine whether or not they develop diabetes. To~     circumvent this difficulty, we will recruit subjects in families with a history of type II~     diabetes:~        -  Parents alive, including at least one type 2 diabetic subject~        -  Adult children (aged over 35 years), some of whom are already presenting type II~          diabetes, and healthy brothers and sisters, who form the control population. Test will~          be done to determine whether healthy subjects are really safe from the risk of diabetes~          (HbA1c measurement and glucose load test).~      The Descendence study will include 500 families at risk involving about 3000 subjects (1000~     subjects with diabetes and 2000 healthy subjects). It is expected to answer the following~     question: for a child born in such families at risk, what is the probability of developing~     diabetes later in life, so that early preventive action may be taken~   "
101593|NCT01727336|"~     The purpose of Part 1 of this study is to evaluate the safety and tolerability of~     dalantercept in combination with axitinib in patients with advanced renal cell carcinoma~     (RCC) to determine the recommended dose level of dalantercept in combination with axitinib~     for Part 2.~      The purpose of Part 2 of this study is to determine whether treatment with dalantercept in~     combination with axitinib prolongs progression free survival (PFS) compared to axitinib~     alone in patients with advanced renal cell carcinoma (RCC).~   "
101594|NCT01727310|"~     Left valvular heart disease has become one of the most common heart disease in Western~     countries. This disease evolve over many years and are characterized by a long phase where~     the patient is asymptomatic.~      it is characterized by discomfort LV filling may worsen and lead typically to a pressure~     increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable~     and may occur at the stage of diastolic or systolic dysfunction.~      Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing~     that it is often very difficult to know if the patient is actually symptomatic. The onset of~     symptoms sign an intolerance to the increase in LV filling pressures and LA , causing~     pulmonary hypertension .~      Therefore, the study of the level of LV and LA filling pressures , if possible by a~     noninvasive method, would identify patients apparently asymptomatic even though their~     condition is advanced.~      Pressures filling pressures can be explored by two methods:~        -  cardiac catheterization, which is a direct and invasive measurement method~        -  echocardiography, which is an indirect measurement method which has the advantage of~          being non-invasive The goal of this research is to compare the two methods.~   "
101595|NCT01727297|"~     This study is to determine, through continuous monitoring with the Reveal implantable~     cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be~     at high risk for having AF and to understand how physicians manage these patients after AF~     has been detected. This study will also seek to identify what patient characteristics are~     most predictive of developing AF.~   "
101596|NCT01727284|"~     The purpose of this research is to see if MR-guided cryoablation can effectively treat~     prostate tumor recurrences.~   "
101597|NCT01727271|"~     This study will compare monotherapy with tenofovir to sequential therapy with pegylated~     interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with~     pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic~     hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be~     be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3~     treatment arms.~   "
101598|NCT01727258|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of~     subjects, and check for sensitive teeth.~      During the first 2 weeks, participants will brush their teeth two times a day with the~     fluoride toothpaste provided.~      Then, if they qualify to continue in the study, participants will be assigned to a treatment~     group. All the groups will get toothpaste currently sold on the market, and one group will~     get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal~     chance of being assigned to any one of the three groups.~      For the next 4 weeks, subjects will use their assigned products according to the directions~     provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they~     understand the directions. They will also have supervised use of the product at Visit 2.~      We will see if the mouthwash helps to reduce tooth sensitivity during the study.~   "
101599|NCT01727245|"~     We want to asses the role of adipose tissue for metabolic complications to obesity before~     and after weight loss (surgery).~   "
101600|NCT01727232|"~     The aim of this large French multicentric retrospective study was to compare the efficacy~     and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's~     immune thrombocytopenia .~   "
101601|NCT01727219|"~     The frequency of depression in COPD patients are substantial and early detection and~     prevention of depression is critical.~      Recently, COPD assessment test (CAT) was developed and validated to assess the impact of~     COPD on patients' quality of life.~      In this prospective study, we will investigate the predictive utility of CAT for predicting~     depression in COPD patients.~   "
101672|NCT01726283|"~     This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical~     and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas~     that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia~     that will be undergoing laser vision correction.~   "
101602|NCT01727206|"~     The study we propose is a pilot phase II, interventional, treatment, open-label, single-arm,~     efficacy/safety clinical trial of a 6-month treatment with tocilizumab (8 mg/kg once~     monthly) in adult patients with extraskeletal Erdheim-Chester disease (ECD). Efficacy will~     be assessed as the effect of the treatment on the size of the measurable lesions, as~     evaluated by bidimensional measurements, and by the impact of the treatment on symptom~     control and on patient quality of life. Safety of the treatment will be determined by the~     analysis of adverse events and of the relevant safety laboratory parameters.~      Secondary objectives of the study will be:~        1. to better characterize the mechanisms underlying such disease and the possible response~          to the treatment. In particular: i) we will investigate the immunophenotypic and~          histomorphologic features of ECD histiocytes; ii) we will gather gene expression data~          from peripheral blood immune cells to better characterize their functional status, to~          define their transcriptional fingerprints and their possible modulation as a result of~          tocilizumab treatment; iii) we will assess the production of soluble mediators and the~          expression of activation molecules by monocytes derived from ECD patients, as well as~          after stimulation with selected inflammatory cytokines; iv) we will investigate the ex~          vivo and in vitro impact of tocilizumab treatment on those markers, for possible use as~          a predictor or indicator of response to treatment.~        2. to investigate the metabolic pattern in ECD patients before and after tocilizumab~          treatment as evaluated by fluoro-d-glucose positron emission tomography (FDG-PET) and~          to verify if it can be an indicator of ECD activity.~   "
101603|NCT01727193|"~     This is a randomized controlled clinical study. The investigators screen of eligible~     patients, randomized divide into the following two groups: corticosteroids + azathioprine~     group, corticosteroids + leflunomide group. The investigators treat the enrolled patients,~     estimate efficacy and observed the side effects according to the requirements of program.~     The investigators establish a clinical database for recording patients date and statistical~     analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis~     patients in the different group prove that what kind of treatment can improve the cure rate.~     The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and~     kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when~     the investigators apply these therapy in the treatment of different clinical types of MG.~   "
101604|NCT01727180|"~     We believe that knowing characteristics of uremic pruritus is the foundation to investigate~     its pathophysiology and offer better skin care for patients with chronic kidney disease. We~     therefore conducted this cross-sectional study to evaluate the characteristics of uraemic~     pruritus.~   "
101605|NCT01727167|"~     This study will test if inhalation of Carbon Monoxide (CO) will increase the numbers of~     mitochondria in heart muscle. Mitochondria are the small components of muscle and other~     cells that convert fuel and oxygen to the easily usable forms of energy (ATP) that power all~     cell's activities. Adequate numbers of healthy mitochondria are essential to heart cell~     function. From animal and other studies we have reason to believe that breathing small~     amounts of CO will signal the body to increase the numbers of mitochondria in heart cells.~     We propose to test this theory in heart valve surgery patients by examining a small sample~     of heart tissue (from the right atrial appendage) that is routinely cut out during the~     preparation of the patient for cardio-pulmonary bypass and that would otherwise be discarded~     by the surgeon. Muscle samples from two groups of subjects will be compared. One group will~     breath CO and the other group will breath room air. If CO is effective, we should notice an~     increase in the numbers of mitochondria in the group that was exposed to CO compared to the~     group that breathed room air.~   "
101606|NCT01727154|"~     The purpose of this study is to evaluate the immune response induced by sipuleucel-T~     (Provenge®).~   "
101607|NCT01727141|"~     This study will assess the efficacy, safety and tolerability of QVA149 in patients with~     moderate to severe airflow limitation.~   "
101608|NCT01727128|"~     To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in~     subjects with mild, moderate and severe hepatic impairment~   "
101609|NCT01727115|"~     The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in~     efficacy than NUTRAMIGEN®~   "
101610|NCT01727089|"~     This randomized phase II trial studies how well bevacizumab with or without anti-endoglin~     monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has~     spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab~     and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by~     targeting certain cells.~   "
101611|NCT01727076|"~     This phase I trial studies the side effects and best dose of recombinant interleukin-15 in~     treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck~     cancer that has spread to other places in the body and usually cannot be cured or controlled~     with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made~     naturally in the body and when made in the laboratory may help stimulate the immune system~     in different ways and stop tumor cells from growing.~   "
101612|NCT01727063|"~     Patients with advanced coronary artery disease usually undergo incomplete myocardial~     revascularization due to the extension and diffuseness of the disease, with very poor distal~     arterial beds unsuitable for direct revascularization.~      This study was designed to test the hypothesis that direct, intramyocardial injection of~     autologous bone marrow cells may further improve myocardial perfusion in patients undergoing~     incomplete bypass surgery.~   "
101669|NCT01726322|"~     Primary Objective :~      To determine whether pre-treatment levels of anti-mullerian hormone predicts ovarian~     follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and~     chemotherapy induced amenorrhea (CIA).~      Secondary Objective~        -  To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant~          chemotherapy regimens.~        -  To assess the correlation between CIA and depletion of ovarian follicular reserve.~        -  To partly externally validate preceding studies of anti-mullerian hormone levels in~          patients receiving neo-adjuvant/ adjuvant chemotherapy for breast cancer.~        -  To determine the efficacy of GNRH agonists in preservation of ovarian follicles in~          premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast~          cancer. Administration of GNRH agonists is dependent on the treating oncologist's~          judgment of the patient's case and practices and is not to be influenced by study~          participation.~   "
101613|NCT01727050|"~     Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for~     the repair of primary unilateral inguinal hernia. Previous studies showed that patients~     underwent TEP have less post-operative pain and earlier return to normal activities.~     However, chronic pain is still a major issue affecting quality of life after TEP with a~     reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of~     mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable~     pain had been reported. Recently several clinical trials showed that mesh fixation with~     fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma.~     A spraying device for application of FS laparoscopically is now available which can achieve~     mesh fixation by using fewer amounts of FS.~      In this study, the investigators aim to compare the effectiveness of using fibrin spray for~     mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized~     controlled trial by allocating patients in two study arm in random manner. The treatment~     group will have the mesh fixed by fibrin sealant spray, whereas the control group will have~     conventional mechanical staples for fixation. Operative procedures and post-operative~     management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month~     after operation to evaluate the operative results and the incidence of chronic pain. Any~     complications related to the mesh and operation will also be recorded.~   "
101614|NCT01727037|"~     Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy~     (surgery to resect these bullae), however this is a major surgery with significant potential~     morbidity and long hospital stays. Many patients are not well enough to have this surgery,~     or may not wish to have it. A less invasive means of attempting to shrink the size of the~     bullae is to directly inject the patients' own blood into the bullae (we believe that this~     can lead to an inflammatory reaction leading to gradual scarring and volume loss). This can~     be performed bronchoscopically in a 20-30 minute procedure using conscious sedation~     (avoiding general anaesthesia).~      The aim of this study is to assess the effects on lung function, quality of life measures,~     functional measures and CT measured lung volumes of bronchoscopic intrabullous blood~     instillation in patients with bullous emphysema.~   "
101615|NCT01727024|"~     This study compared the correct use of and patient preference for two drug delivery systems~     (inhalers) in patients with COPD~   "
101616|NCT01727011|"~     Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept~     whose validity is being assessed on its non-inferiority in terms of local control compared~     to whole breast irradiation. At least eight phase III trials attempting to answer this~     question and thus provide a sufficient level of evidence to make this concept a new standard~     of care for sub-groups of patients well defined (1).~      However, without waiting for the final results of these randomized trials (which will not be~     fully valid with a drop of at least ten years), the American societies (ASTRO) and European~     (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups~     according to the risk to the patient in terms of local recurrence after IPAS. And are~     defined by the ESTRO:~        -  The low-risk group (suitable for ASTRO)~        -  The intermediate-risk group (cautionary in ASTRO)~        -  The high-risk group (not suitable for ASTRO) (2.3). Therefore, it is possible to~          propose to a patient a randomized clinical tria IPAS, to subject it belongs to the~          group low risk. The results of phase II trials as a long-term analysis of the matched~          team of William Beaumont Hospital (4) and the phase III trial using intra-operative~          radiation photons in low energy X whose results were recently published (5) confirm the~          value of this new therapeutic concept for post-operative breast cancer at low risk of~          local recurrence.~      In France, the therapists were quickly directed to a sub-population for which the IPAS could~     represent a real improvement in the therapeutic management in significantly reducing the~     number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6).~     Several French phase II trials were started specifically targeting the female population~     aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation~     électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high~     dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged~     into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green~     Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9).~      On a technical level, two main approaches are used (10):~        -  Irradiation intraoperative electron or low-energy photons,~        -  Radiation after surgery The advantage of intraoperative irradiation is the optimal~          reduction of total processing time radio-surgery because the patient is irradiated~          during the lumpectomy. However, 15-20% of these patients receive partial breast~          irradiation, as histo-prognostic criteria provided in the histologically final report,~          confirm the non-adapted indication of IPAS (5).~      In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS~     but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days~     separated by at least 6 hours).~   "
101617|NCT01726998|"~     The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted~     locomotor training on motor recovery of lower extremities and walking ability compared with~     the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.~      72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered~     within 6 months were enrolled and randomly assigned into 2 groups. The subjects with~     congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk~     independently before stroke attack were excluded.~      Two groups received 30 minutes conventional gait training including Neurodevelopmental~     Treatment (NDT) basically. The robotic assisted locomotor training group received additional~     robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland)~     daily for 4 weeks, and the conventional gait training group received additional daily~     conventional gait training with NDT for the same periods. The independent walking~     ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer~     assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each~     lower extremity muscles were assessed before, during (2weeks) and after training. And the~     independent walking ability were followed until 3 months.~   "
101618|NCT01726985|"~     Heart failure is the leading cause of hospitalizations and readmissions in the United States~     and is a tremendous economic strain on our healthcare system. There is currently, based on~     national averages, a 30% readmission rate and 10% mortality rate within 3 months of being~     hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers~     such as BNP to guide inpatient heart failure management. Our own CCF retrospective study~     showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L,~     and discharging patients with serum sodium above 135 reduces readmission rates~     significantly. The purpose of this study is to prospectively use the above mentioned goals~     in the treatment of heart failure in order to reduce heart failure readmission and mortality~     rates.~   "
101619|NCT01726972|"~     The proposed study aims to objectively assess 2-year clinical and radiographic results for~     the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This~     retrospective radiographic review will provide evidence for equivalence or superiority in~     curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is~     utilized in conjunction with cement at the glenoid.~   "
101620|NCT01726959|"~     The objective of this study is to identify genetic predictors of individual methotrexate~     (MTX) response in patients with rheumatic diseases by determining genetic and metabolomic~     factors related to nutrient metabolism and drug transport.~      The development of better genetic predictors of individual MTX treatment response would~     provide invaluable prognostic information prior to initiating treatment, which would allow~     more appropriate choice of therapy, decreased adverse events, and more efficient~     dose-escalation of the drug, with ultimate benefits of improved effectiveness and~     tolerability rates in patients being treated with MTX for autoimmune diseases.~      Despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic~     autoimmune diseases since 1951, MTX's efficacy and safety profile limit its use: MTX is~     discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability.~     Upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite~     prophylactic measures such as the co-administration of folic acid. The causes of primary~     failure, secondary failure, and adverse events of MTX may be related to genetic variation of~     dihydrofolate reductase (DHFR) and other genes involved in folate metabolism, one-carbon~     transfer, and drug transport. The purpose of this study is to identify genetic variations~     involved in methotrexate response so that we may better understand the pharmacodynamics of~     MTX metabolism in patients with rheumatic diseases.~   "
101621|NCT01726946|"~     A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135~     in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C~   "
101622|NCT01726933|"~     The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to~     active control and placebo in patients with moderate to severe chronic plaque psoriasis~   "
101624|NCT01726907|"~     Traditional transcervical incision of the upper neck is a safe and effective approach for~     resection of the submandibular gland (SMG). However, external scar at the highly visible~     area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic~     scar or keloid. Recently, the investigators reported our surgical technique of~     'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed~     excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our~     previous feasibility study of robot-assisted SMG resection, the investigators proposed that~     robot-assisted technique may overcome the limitations of endoscopic instruments with rigid~     and straight nature without articulation and surgical view of two-dimension. In addition,~     the ergonomically designed operating system was more convenient for the surgeon considering~     the frequent collision of the endoscopic instruments and reversed hand-eye coordination in~     endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the~     two techniques has not been reported in the literature.~      In this study, the investigators made a prospective comparative study of robot-assisted~     versus endoscope-assisted SMG resection to determine whether robot-assisted technique has~     benefits regarding early surgical outcomes.~   "
101625|NCT01726894|"~     To determine the adverse events and genito-urinary side-effect profile of focal therapy to~     treat localised low to intermediate risk prostate cancer using irreversible electroporation~     (Nanoknife™).~   "
101626|NCT01726881|"~     People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to~     80% of the patients will develop chronic pain called central pain and describe the pain~     as: burning, stabbing, or like electricity. Central pain mechanism is unknown and~     therefore treatment is currently not effective.~      It is hypothesized that chronic pain is associated with impaired function of the systems~     regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury~     patients. Presence of such a connection, between the regulating system dysfunction and~     central pain, will help both predicting the risk of central pain and develop a treatment.~      The current research objective is to make several sensory measurements which will measure~     the functioning mechanisms of regulation and control of the pain. These measurements are~     accepted throughout the world and are based on psychophysical assessment of patients. these~     Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients~     demonstrate impairment in the regulation of pain. Finding such a link between central pain~     and impaired regulation could shed light on the mechanism of central pain. In addition,~     these measurements are designed to assess whether fresh spinal cord injury patients that~     have not yet developed central pain demonstrate impairment in the regulation of pain~     immediately after the injury. By repeated assessments of pain regulation capabilities, which~     will be made to fresh Spinal Cord Injury patients during the first months of injury, and~     comparing the results of these measurements between those who will develop center pain and~     those who will not, we could identify indicators for predicting the risk of central pain.~     Another goal of the study is to investigate the efficacy of central pain treatment, using a~     TENS, when the parameters of the TENS treatment will be built according to the level of~     functioning of the regulating systems of the individual.~   "
101627|NCT01726868|"~     The aim of this study is to evaluate efficacy and safety of blood purification therapy on~     renal dysfunction by cholesterol crystal embolism.~   "
101628|NCT01726855|"~     The purpose of this study was to report a new method of flexor tendon repair in zone II with~     combined standard modified Kessler technique and vascularized finger dorsal fascial flap~     pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to~     finger volar for placement of a mechanical barrier between flexor digitorum superficialis~     /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair~     in zone II with this new technique were compared with those of 32 patients (Group B) with~     flexor tendon repair in zone II with standard modified Kessler technique. This new technique~     may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.~   "
101629|NCT01726842|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus.~   "
101630|NCT01726829|"~     This is a randomized prospective single blind trial to evaluate blood glucose control~     overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP)~     system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana,~     Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each~     subject will participate in four consecutive over nights under closed-loop with MDLAP, and~     four additional over nights under regular sensor augmented pump therapy at home with a~     washout period of 10 ± 3 days between arms.~   "
101631|NCT01726816|"~     This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre~     trial.~        -  Screening period (4 week)~        -  Double blind treatment period (16 weeks)~   "
101632|NCT01726803|"~     Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped~     care approach with initial treatment of education and advice to remain active. Referral to~     physical therapy is considered only when patients fail to recover after a few weeks. Recent~     research has led to the identification a subgroup of patients likely to experience rapid,~     pronounced, and sustained decreases in disability and pain with a brief manipulation and~     exercise intervention, suggesting it may be more cost-effective to manage this sub-group~     with early referral to physical therapy instead of the usual care approach. The integration~     of this evidence into routine practice has not been evaluated. We will assess the outcomes~     of integrating this evidence into the management of patients with low back pain. The study~     is a randomized trial, comparing management with early manipulation with the current care~     process model. Patients fitting the inclusion criteria will be randomized into one of two~     groups. One group will be managed with the current care process model. The other group will~     be managed consistent with the decision rule recommending early referral for a brief~     manipulation and exercise intervention during the first 4 weeks. Patients will be followed~     over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct~     medical costs. The study will examine the costs and effectiveness of integrating the~     alternative care model into practice.~   "
101633|NCT01726790|"~     To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection~   "
101670|NCT01726309|"~     Primary Objective:~      Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and~     the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.~      Secondary Objectives:~      Correlation of SNP profile with indicators of tumour response parameters, such as~     radiological response, duration of response, time to progression (TTP), overall survival~     (OS) time, incidence of non-dermatological adverse events.~   "
101671|NCT01726296|"~     This clinical trial studies adherence to survivorship care guidelines in health care~     providers for non-small cell lung cancer or colorectal cancer survivor care. The completion~     of an educational intervention by health care providers may increase compliance and~     adherence to National Comprehensive Cancer Network guidelines for survivorship care.~   "
101673|NCT01726270|"~     Multicenter trial conducted in Pharmacy retail centers~   "
101634|NCT01726777|"~     Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low~     vitamin D levels are associated with increased diabetes risk and that vitamin D may protect~     against diabetes by reducing chronic inflammation and improving insulin sensitivity and~     insulin secretion. However, no studies have been able to show that vitamin D actually~     reduces post-prandial blood glucose levels, the most clinically relevant marker of diabetes.~     Previously the investigators have shown that cheddar cheese and low-fat cheese can be~     fortified with high levels of vitamin D and that this cheese is at least as a effective as~     vitamin D supplements in raising blood vitamin D levels.~      The main purpose of this study is to see whether vitamin D enriched cheese can improve oral~     glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g~     sugar) in people who have low vitamin D levels and are at risk for developing T2D.~      Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin~     secretion, markers of inflammation, blood cholesterol levels, and safety markers such as~     urinary calcium excretion.~   "
101635|NCT01726764|"~     The goal of the study is to examine the difference of the pharmacokinetics of metformin with~     and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives~     include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose~     tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile~     following this possible interaction.~   "
101636|NCT01726751|"~     To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a~     4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design,~     active stimulation is compared to a period without stimulation, with an ensuing tailing~     stimulation period, twice as long. Patients recorded average pain level, pain attacks,~     number of diarrheas and global quality of life. At the end of the study patients can choose~     to retain their SCS stimulation system or have it removed.~      The outcome of the present trial will show whether SCS is a useful treatment of IBS. The~     long-term follow-up will show the continuous amelioration of SCS over at least six months.~   "
101637|NCT01726738|"~     This phase II study in 20 patients with BRAFV600E mutant, unresectable stage III/IV melanoma~     is designed to explore the mechanisms by which tumors acquire resistance to the combination~     of a BRAF inhibitor (dabrafenib) and MEK inhibitor (trametinib). Tissue will be collected at~     baseline and at progression. Markers of resistance will be explored by performing near~     kinome-wide profiling on tumor samples, and in patients who co-enroll in institutional~     protocol LCCC1108, by sequencing tumors using NextGen DNA sequencing technology. Overall~     response rate and duration to this combination will also be assessed.~   "
101638|NCT01726725|"~     Patients are chosen to participate in this study because they will undergo a particular type~     of brain surgery to treat their hemifacial spasm. This surgery is called microvascular~     decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by~     one or more blood vessels and this contact produces the facial twitches. The investigators~     do not know why a blood vessel that touches the facial nerve produces facial twitches. The~     investigators are interested in investigating this during your surgery. A total of 25~     participants are expected to participate in this study.~   "
101639|NCT01726712|"~     The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and~     culturally sensitive intervention designed to capitalize on organic yet underutilized social~     support networks in the lives of young black men who have sex with men (YBMSM) who have been~     recently diagnosed with HIV. The intervention has been developed with input from clients and~     their support network members, case managers, social workers, HIV primary care providers and~     pastoral care at a Federally Qualified Health Center. The goal of the intervention is to~     improve retention in care for newly diagnosed YBMSM who present for their first HIV primary~     care clinic appointment.~   "
101640|NCT01726699|"~     Study the genetic traits of cancerous tissues and to help improve cancer treatment by~     developing tumor models for studying new cancer drugs.~   "
101641|NCT01726686|"~     The purpose of this study is to evaluate the effect on postoperative pain and function by~     adding intraarticular continuous infusion pump with local anesthetic after total knee~     arthroplasty where local infiltration analgesia has already been given.~   "
101642|NCT01726673|"~     The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct~     Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy~     lead to a greater functional recovery in upper limb mobility after stroke than that provided~     by robotic arm therapy alone.~   "
101643|NCT01726660|"~     The purpose of this study is to determine if tailoring multiple sessions of upper extremity~     robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming;~     active range of motion vs. functional practice)can optimize therapeutic results and lead to~     greater functional returns in arm mobility after stroke.~   "
101644|NCT01726647|"~     Objectives:~      The primary objective of this clinical trial is to characterize metabolic signatures~     associated with abdominal fat distribution in 40 women with different BMI 29-40 and~     different abdominal distribution of fat (visceral vs. sub-cutaneous fat).~      No intervention with a product is planned. The subjects will be given one high fat meal with~     commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to~     test the post-prandial metabolic response.~   "
101645|NCT01726634|"~     Evaluate if the elastic tapping application on the scapular region can interferer~     immediately on the performance during the upper limb closed kinetic chain test on jiu jitsu~     practitioners.~   "
101646|NCT01726621|"~     This six center international study will include two United Kingdom National Health Service~     centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The~     objective of the study is to evaluate subject acceptance of the a new insulin pump and~     transmitter together with the accompanying training materials. Descriptive data from~     participant questionnaires and device uploads will be evaluated.~      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of~     age upwards, who currently use an insulin pump in the management of their type 1 or type 2~     diabetes, will be invited to participate. Each subject will be trained on the study device~     and then use it for approximately six weeks. During this time there will be three in-clinic~     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of~     this period, they will revert back to their original insulin pump and complete a~     questionnaire on the study pump training materials, features and usability.~   "
101647|NCT01726608|"~     The purpose of the study is to investigate if a technique called Simplicity III®~     Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain.~     Currently there are a variety of treatments for managing this pain but there is still some~     doubt as to which treatments are the most effective. Simplicity III® is one such treatment~     for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical~     current to generate heat around the tip of the needle placed close to the nerves that supply~     the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and~     improves pain.~      The traditional method used to treat this type of pain uses multiple injections to target~     the nerves supplying the joint. This method is however both time consuming and the results~     are variable depending upon the number of injections. Therefore a new electrode, called the~     Simplicity III®, was developed to allow the treatment to be undertaken using fewer~     injections. Although this treatment has received formal approval, undergone conformity~     assessment and is available in certain specialist NHS centres for clinical use, there is~     presently limited evidence with regards to its clinical efficacy. We wish to test the~     effectiveness of this new device in treating sacroiliac joint pain. The best way to prove~     the clinical effectiveness is to compare Simplicity III® against an identical procedure~     where the electrode is not switched on and neither the patient nor the doctor is aware~     whether it was switched on. Once pain has been assessed at 3 months, those patients not~     receiving active treatment and remaining in pain will be offered the active treatment.~   "
101648|NCT01726595|"~     The investigators hypothesize that doctors and nurses can undergo a brief period of training~     and then use ultrasound to accurately measure blood flow in a forearm artery after a brief~     period when this flow is interrupted with a blood pressure cuff, a measurement the~     investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood~     vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood~     vessel function. When measured by experienced ultrasound experts, low reactive hyperemia~     strongly predicts death in critically ill patients with infection (severe sepsis).~      The investigators are conducting this study to determine if doctors and nurses, without~     specific pre-existing expertise in ultrasound, can be trained to make these measurements~     accurately. If so, the investigators will prove that these measurements can be applied~     reliably in real-world practice.~      The investigators also hypothesize that reactive hyperemia predict the outcomes of illness~     not just in patients with severe infection, but in other critically ill patients as well.~      Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff~     occlusion is linked with other abnormalities of blood, previously identified in critically~     ill patients. For example, red blood cells from patients with severe sepsis have been shown~     to be stiffer than normal, so they are less able to flow along the small blood vessel~     passages of the body. Red blood cells become stiffer when there is a certain type of stress~     in the body known as oxidative stress.~      If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative~     stress are linked, the investigators hope to develop new treatments that reduce oxidative~     stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia.~     Improvements in reactive hyperemia indicate improvements in small blood vessel function.~     Better small blood vessel function means better delivery of oxygen throughout the body. The~     investigators believe that this will improve outcomes for critically ill patients.~   "
101649|NCT01726582|"~     See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm~     :~      In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is~     cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular~     profiling). The results of the test are used by the doctor to recommend therapy~     (chemotherapy and radiation therapy) that the patient will receive before having surgery to~     remove the adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is~     removed is tested again. The results of that test are used to guide the choice of therapy~     after surgery.~      The chemotherapy drugs and the radiation therapy used in this clinical trial are already~     approved for treatment of pancreas cancer. This trial is intended to establish which~     treatment is best for a specific patient, based on test results from that patient's actual~     adenocarcinoma. In the past, the decision as to which treatment the patient will receive was~     not based on testing of the actual adenocarcinoma.~      Hypothesis: Resectability rate, overall survival rate and progression-free survival will be~     superior in patients with adenocarcinoma of the pancreas who receive targeted personalized~     therapy, as compared to historical data of patients who received standard therapy.~   "
101650|NCT01726569|"~     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma~          patients.~        2. Investigate the effect of educational intervention affect the degree of satisfaction in~          glaucoma patients.~        3. Investigate the effect factors of postoperative satisfaction.~   "
101651|NCT01726556|"~     Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for~     undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument~     designed for the same purpose which is claimed to be more user-friendly. The two devices~     have not been compared in a head-to-head trial in published literature. The investigators~     attempt to conduct a randomised comparative trial between the two devices.~   "
101652|NCT01726543|"~     It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep~     Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a~     Randomised, Prospective Study.~   "
101653|NCT01726530|"~     Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually~     applied but there is no perfect choice. It depends on physician's skill and situation. The~     best regimen is patient-controlled analgesia, but it requires an expensive equipment.~     Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release~     fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.~      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may~     provide good analgesia for 72 hours.~   "
101654|NCT01726517|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin~     (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1~     hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants~     who had previously received a regimen containing a protease inhibitor for the treatment of~     HCV.~   "
101655|NCT01726504|"~     The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe~     functional constipation compared with sham acupuncture, used as placebo; the secondary~     purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.~   "
101656|NCT01726491|"~     The investigators are trying to understand the role of DNA (deoxyribonucleic acid)~     methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a~     normal chemical process in the body that modifies DNA. By studying this, the investigators~     hope to better understand the causes of insulin resistance.~   "
101657|NCT01726478|"~     The purpose of the study was to determine whether 2.5 international units of oxytocin gives~     adequate uterine tone and is safe as compared to 10 international units of oxytocin~     following caesarean section delivery at Mulago hospital.~   "
101658|NCT01726465|"~     This is a prospective double-blind randomized phase II clinical trial, with two groups of~     intervention (one with administration of N-acetylcysteine and the other with administration~     of methylprednisolone), and one group of placebo. The purpose of this study is to~     investigate the role of N-acetylcysteine and Methylprednisolone in the modulation of warm~     ischemia of the liver during hepatic resection. In fact to avoid massive blood loss in liver~     surgery, continuous or intermittent vascular clamping of the hepatic hilum ('Pringle~     maneuver') is generally used with good results. However, as a consequence, ischemia and~     subsequent reperfusion result in complex metabolic, immunological, and microvascular~     changes, which together might contribute to hepatocellular damage and dysfunction. This~     phenomenon, known as ischemia-reperfusion (IR) injury of the liver, is a complex multi-path~     process leading to the activation of some inflammatory pathways. Any patient candidate to~     liver resection will be enrolled in the study based on the aforementioned criteria. The~     primary objective of the study is to assess the real efficacy of Methylprednisolone and~     N-acetylcysteine in reducing the secondary damage from ischemia reperfusion injury in liver~     resection and in reducing inflammatory response. Secondary objective of the study is whether~     the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative~     liver failure, improvement of postoperative liver function, and reduction of blood~     components transfusions. The randomization will be done the day before the operation. The~     drugs will be prepared in a blind fashion by the hospital pharmacy. The hospital pharmacy~     will provide to each patient a drip to make bolus of about an hour before the start of the~     liver resection and a syringe pump for an infusion of approximately 6 hours. If the patient~     is enrolled and randomized in the placebo arm, he/she will receive 250 ml of glucose 5% plus~     the infusion of 100 ml of glucose 5% If the patient is randomized in the Methylprednisolone~     arm, he/she will receive a dose of 500 mg in 250 ml of glucose 5% plus 100 mg of glucose 5%.~     If the patient is randomized in the N-acetylcysteine arm, he/she will receive a dose of 150~     mg/kg in 250 ml of glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml glucose 5%.~     Systematic sampling of liver function tests will be done the day before the operation, at~     the end of the operation, as well as in postoperative day 1, 3, 5 and 7.~   "
101659|NCT01726452|"~     Primary Objective:~      To evaluate one, two and three year survival of patients treated with resection plus~     neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.~      Secondary Objective(s):~      To evaluate the effect of both neoadjuvant regimens on clinical and pathological response~     rate (in particular relief of dysphagia, improvement in health related quality of life~     (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression~     grade, node-positivity, post-operative pathology, disease-free survival, time to treatment~     failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).~      Exploratory Objective(s):~      Translational Research: The collection of blood and tissue samples for storage in the bio~     bank for future research.~   "
101660|NCT01726439|"~     To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of~     Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy,~     de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B~     (CHB) patients who are naive to NUC at enrollment to this study~   "
101661|NCT01726426|"~     The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not~     known. This can be evaluated by administering probiotics. Thirty patients from an arsenic~     affected area will be provided two probiotics capsules per day orally for 12 weeks and stool~     samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.~     Similar number of arsenic exposed controls and healthy volunteers from the same area will be~     included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may~     be modulated by probiotics in arsenicosis patients.~   "
101662|NCT01726413|"~     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent~     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,~     and costs from a public health perspective. Painful diabetic neuropathy affects~     approximately 16% of patients with diabetes. Pharmacological agents used in the management~     of painful DPN mainly include tricyclic antidepressants, selective serotonin and~     norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available~     treatment options do not give total relief, are not effective in all patients, and only~     about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are~     required for the treatment of DPN. The primary outcome measures will be the change from~     baseline to end of treatment in the mean 24-hour average pain intensity.~   "
101663|NCT01726400|"~     The standard treatment of chronic hepatitis C infection is pegylated interferon alpha~     combined with ribavirin. Anaemia is a common complication occurring in up to 30% of~     subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose~     reductions, reducing the likelihood of sustained viral response. Recent data shows that~     interferon alpha may increase hepcidin (a key iron regulator) production, resulting in~     impaired iron availability for production of red blood cells. In this study, we will~     evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon~     containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and~     readily available oral hepcidin inhibitors could be trialled to potentially reduce the~     impact of interferon alpha induced anaemia.~   "
101664|NCT01726387|"~     Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very~     often these conditions remain undiscovered and/or untreated.~      In order to ease this urgent health care problem in the future, the investigators conduct a~     cluster-randomized controlled trial, implementing a tandem working cooperation between a~     nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its~     own practise.~      The CA's task is to enhance the patients abilities to engage in a better self-management of~     their psychological symptoms and complaints, to enhance self-efficacy and empower the~     patients to tackle problems of daily living.~   "
101665|NCT01726374|"~     High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP~     (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the~     40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles~     of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these~     patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more~     chemotherapy cycles on a population basis.~      If a single cycle of BEP at the dose used in advanced disease had a similar high rate of~     relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the~     overall burden of chemotherapy and healthcare resource usage and would be likely to lead to~     a change in practice globally.~   "
101666|NCT01726361|"~     The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care~     compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home~     placement.~   "
101667|NCT01726348|"~     The purpose of this study is to assess the safety and effectiveness of darunavir for the~     treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.~   "
101668|NCT01726335|"~     The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting~     risperidone when switching from oral antipsychotics in participants with schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self).~   "
101675|NCT01726244|"~     One of the most cost effective intervention is to avoid unnecessary hospitalizations in the~     national health system. These unnecessary admissions are increasing for several years,~     reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or~     heart failure at two months of hospital discharge. There is scientific evidence suggesting~     that a multidisciplinary intervention consisting in controling disease and stress associated~     with disease, and modifying eating habits could reduce the number of hospitalizations due to~     disease decompensation.~      The main objective of the study is to assess the rate of readmissions at year of~     multidisciplinary intervention in patients with COPD and / or heart failure.~      We will select 144 patients who will be randomized to two groups (control and intervention~     group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months~     and 12 months of hospital discharge).~      Patients assigned to the intervention group will be receive three educational sessions (one~     of them will be imparted by nursing, another by the nutritionist and the last one by the~     psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer~     monitoring by the nutritionist).~      Patients assigned to the control group will receive usual care in clinical practice.~   "
101676|NCT01726231|"~     In laparoscopy, over %50 of the all complications occur during establishment of the~     pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance~     between the abdominal wall and the intrabdominal structures. Elevation of the anterior~     abdominal wall is recommended for the access to peritoneal cavity in literatures however the~     benefit exactly has not proved. This study aimed to determine the distance from anterior~     abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to~     represent this distance -on the average- generate the safe range whether or not and compare~     with this distance and patient's age, BMI and parity.~   "
101677|NCT01726218|"~     It is well known that the motor area of one hemisphere of the brain (motor cortex) controls~     the movement of the opposite of the body. However, it is not clear whether as the movement~     becomes more complicated, the motor cortex of both hemispheres of the brain are involved.~     Currently the role of the motor cortex on the same side of the body (referred to as~     ipsilateral motor cortex) in hand performance remains controversial. The investigators~     demonstrated previously in healthy subjects that transiently lowering the activity of~     ipsilateral motor cortex improved the performance of the opposite hand. What is not know are~     the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation~     (TMS) is a device that allows the non- invasive stimulation of the brain. When brain is~     stimulated repetitively at a very low rate and low intensity for about 15 minutes, the~     stimulated brain area becomes less active. This effect lasts 10 minutes and is called a~     transient artificial lesion as it mimicks the effects of transiently interfering with the~     function of the stimulated brain area. In the present study the investigators will conduct~     experiments using repetitive TMS to downregulate the activity of the motor area as in~     previous experiments and measures its effect on activity of motor cortex of both~     hemispheres. The investigators will study healthy subjects. It would be important to~     understand the effects in more detail for the design of treatment strategies in patients~     after stroke, which will be a topic of future studies.~   "
101678|NCT01726205|"~     The purpose of this study is to assess the efficacy of pregabalin or pregabalin and~     continuous wound infusion versus placebo for analgesia following thoracotomy~   "
101679|NCT01726192|"~     The purpose of this study is to assess the efficacy of the hydrolocalization technique for~     placement of femoral perineural catheters in comparison with stimulating catheters. A non~     inferiority trial.~   "
101680|NCT01726179|"~     the goal of the project is to investigate the clinical efficacy of management of early~     caries lesions by resin infiltration and to further scrutinize the patient stress~     experiences.~   "
101681|NCT01726166|"~     Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up~     to 10%. It is more frequent in male and preterm newborn infants and can lead to significant~     problems in infants including blood infections, kidney infections, and kidney scarring which~     can affect how the kidneys work later in life.~      Analysis of collected urine for the presence of bacteria or fungus is the only way to make a~     certain UTI diagnosis. Urine culture results may take 24 to 48 hours to become available.~     Sterile collection of urine can be achieved in newborn infants by urinary catheterization~     (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration~     (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean~     catch' where urine is collected into a sterile bottle as the baby urinates during~     preparation for UC. The main advantage of SPA is that it bypasses the bacteria that normally~     resides in the urethral opening, thus minimizing the risk of contamination. Some studies~     have suggested that SPA is better than UC for collecting urine in a sterile fashion in the~     neonate due to the difficulty of doing sterile UC in small infants resulting in more~     contaminated samples (also called a false-positive urine culture); there are some problems~     with the way these studies were done so there is still no clear best choice. UC is commonly~     used in many Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be~     done by the nursing staff, and generally has a higher chance of obtaining urine. SPA is a~     simple and safe alternative and, although some studies suggest that it is more painful than~     UC, it it performed more quickly. The reported success rate for SPA is variable, but is~     greatly increased when an ultrasound confirms urine in the bladder before doing the SPA. The~     question remains: what is the best method for sterile collection of urine in newborns and~     young infants? In this study, the investigators will try to answer this question by~     collecting urine from infants admitted to our NICU using either ultrasound guided SPA or UC~     and then comparing the contamination rates between these two methods.~      The investigators hypothesize that SPA will result in less contamination of urine samples.~      The investigators also hypothesize that there will be more success in obtaining an adequate~     urine sample (0.5 ml) by SPA, SPA will be quicker to perform, and that there will be no~     difference in associated complication rates between SPA and UC.~   "
101682|NCT01726153|"~     The purpose of this study is to evaluate the efficacy of an online intervention in~     increasing condom use among HIV+ gay males.~   "
101683|NCT01726140|"~     The aim of study is to evaluate whether the application of a continuous positive airway~     pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia~     and re-intubation rate.~   "
101719|NCT01725659|"~     PURPOSE. After stroke many patients are unable to engage in normal upper limb functional~     activities, which may restrict them from participation in meaningful life roles. For many,~     conventional rehabilitation does not restore upper limb function to a useful level. The~     purpose of this research is to investigate the benefits of three promising motor learning~     interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning~     (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).~   "
101720|NCT01725646|"~     1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients~        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients~   "
102675|NCT01713153|"~     This is a large, community-based, cluster-randomized trial to compare routine prophylactic~     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly~     during the third stage of labor~   "
101684|NCT01726127|"~     The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups~     fruits and vegetables daily. However, at current intake levels, fruit consumption will have~     to improve by more than 100% and vegetable intake by 50% to meet this recommendation.~     Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes~     are not considered. It is possible that improved fruit and vegetable intake will have~     beneficial health effects. For example, higher intakes of fruits and vegetables, and~     particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.),~     are associated with lower rates of many degenerative diseases, including some cancers, yet~     this group of vegetables may continue to be under-consumed due to their strong flavors. A~     supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc.~     Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift~     estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from~     breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16).~     In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts),~     Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen~     metabolites in healthy premenopausal women will be compared over an eight-week period. The~     investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio~     as compared to daily consumption of a combination of Brussels sprouts and broccoli or a~     placebo, suggesting reduced breast cancer risk.~      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,~     lutein and lycopene with dietary carotenoid intake as measured by a food frequency~     questionnaire and body composition will be evaluated in healthy premenopausal women.~     Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues~     and their concentration in human blood reflects dietary intake of carotenoid-rich foods.~     Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual~     status, but are inversely associated with body fatness. Thus, serum carotenoid~     concentrations may serve as a functional marker for chronic disease risk associated with~     excess body fat.~   "
101685|NCT01726114|"~     The purpose of this study is to compare glucose measurements from the C8 MediSensors~     non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow~     Springs Instrument(YSI) blood glucose analyzer.~   "
101686|NCT01726088|"~     The purpose of this study is to determine if modafinil is more effective than placebo in the~     treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been~     deployed to Iraq or Afghanistan.~   "
101687|NCT01726075|"~     To assess whether neuroprotective drugs administered topically (somatostatin and~     brimonidine) are able to prevent or arrest the development and progression of~     neurodegenerative changes~   "
101688|NCT01726062|"~     A randomized, controlled, parallel group design will be used to test whether a Secondhand~     Smoke Exposure program initiated in the hospital and completed in the home using~     motivational interviewing plus motivational incentives (MI+) is more effective than~     Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.~   "
101689|NCT01726049|"~     Aim of the study is to investigate whether Sildenafil treatment results in a reduction of~     pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of~     exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF)~     with pulmonary hypertension ( PH).~   "
101690|NCT01726036|"~     The purpose of this study is to compare two commonly used circumcision clamps (Gomco and~     Mogen) to see which results in less neonatal pain.~   "
101691|NCT01726023|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus~     Metronidazole compared to Meropenem for treating hospitalized patients with complicated~     intra-abdominal infections.~   "
101692|NCT01726010|"~     The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy~     Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the~     upper gastrointestinal tract.~   "
101693|NCT01725997|"~     The study aims to answer if surgery with hook plate for acute dislocation of the~     acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to~     conservative treatment.~   "
101694|NCT01725984|"~     A single-center retrospective chart review of AdVance and AdVance XP subject data, combined~     with prospective follow-up of the same subjects to confirm continence, adverse event, and~     quality of life status. This study includes patients previously implanted with an AdVance or~     AdVance XP male sling.~   "
101695|NCT01725971|"~     Silicosis is a chronic and incurable occupational disease that can progress independent of~     the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may~     help to improve our understanding of the changes in lung mechanics, as well as in the~     detection of these changes.~      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory~     impedance and evaluated the diagnostic use of the FOT in these patients. For this, the~     investigators used spirometry to classify airway obstruction, which resulted in four~     categories: control, patients with normal exam, mild obstruction, and moderate-to-severe~     obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the~     resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the~     mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was~     evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic~     potential was evaluated by investigating the area under the receiver operating~     characteristic curve (AUC).~   "
101696|NCT01725958|"~     Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional~     Supplement Combination on Body Weight Management over a 90-day period~   "
101697|NCT01725945|"~     Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot~     study aims to provide effect size estimates and justification, clinical trial and~     intervention feasibility data, and procedural materials for a full-scale randomized~     controlled trial that will determine the efficacy and mechanisms of action of the Dietary~     Approaches to Stop Hypertension (DASH)—a recommended dietary pattern based on proven~     cardiovascular benefits—as adjunct therapy to standard care for adults with uncontrolled~     asthma.~   "
101698|NCT01725932|"~     While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression~     in West, only limited amount of research has been conducted to find assess its effectiveness~     in low and middle income countries. We have developed culturally sensitive CBT during the~     last few years in Pakistan. Pakistan has high rates of depression. And there is currently a~     need to develop and test evidence based treatments which are culturally sensitive and cost~     effective. IN this project we will be assessing the effectiveness of a culturally sensitive~     CBT based self help intervention for depression in Pakistan against care as usual, using a~     randomized controlled design.~   "
101748|NCT01725282|"~     In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major~     depressive disorder patients with lack of response to existing antidepressants, with the aim~     of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose~     groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.~   "
101699|NCT01725919|"~     Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for~     residual motor disability in chronic stroke. Its effectiveness is believed to be due, at~     least in part, to the therapy's ability to aid the brain in rewiring itself. For example,~     CI therapy produces increases in the amount of grey matter (the parts of the brain where~     neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier~     et al., 2008). The cellular and molecular mechanisms that are responsible for this increase~     in grey matter volume are not known, however. Thus, it is unclear how the therapy helps~     brains rewire themselves. This study aims to better understand the timecourse and~     cellular/molecular nature of brain changes during CI therapy. Because there is currently no~     way to directly measure cellular/molecular changes in the brain noninvasively, this study~     will infer what is happening on a microstructural level using new MRI techniques (three~     dimensional pictures of the brain). For example, by charting the timecourse of grey matter~     changes during CI therapy, and cross-comparing this to what is known about the timecourses~     of different cellular/molecular processes, the investigators can gain a greater~     understanding of what cellular processes may be responsible for increases in grey matter.~     The investigators will gain additional information about which cellular processes are~     important for rehabilitation-induced improvement by measuring larger-scale changes (e.g.,~     amount of blood flow through different brain areas) that accompany cellular changes. The~     investigators are hopeful that by better understanding how CI therapy can change the brain,~     the effectiveness of rehabilitation can be improved upon. For example, insight into the~     mechanisms of rehabilitation-induced brain change may suggest particular drug targets to~     increase brain plasticity. This study will help us better understand how the brain repairs~     itself after injury.~   "
101700|NCT01725906|"~     We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs.~     empiric therapy in the third line therapy. Factors affecting the eradication rates,~     including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be~     assessed.~   "
101701|NCT01725893|"~     Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the~     treatment of choice and many methods have been proposed. The purpose of this study is to~     evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor~     tendons.~   "
101702|NCT01725880|"~     The purpose of this study is to determine the long term safety and preliminary efficacy of~     intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord~     trauma.~   "
101703|NCT01725867|"~     the purpose of this study is to compare the effect of physical therapy (PT) program and oral~     appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).~   "
101704|NCT01725854|"~     The purposes of this study are to evaluate the acceptability and utility of a mind-body~     intervention on a convenience sample of Soldiers (n=120) who have screened positive through~     RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the~     effectiveness of this Relaxation Response (RR) intervention designed to decrease the~     physiological and psychosocial effects of stress and trauma. The study aims to enhance the~     psychological health of Soldiers with a RR intervention designed to promote self-awareness~     of physiological responses to stress and the ability to increase relaxation responses.~   "
101705|NCT01725841|"~     Resistance to broad-spectrum cephalosporins through the acquisition and expression of~     Extended-Spectrum β-lactamase (ESBL) among Enterobacteriacea is increasing. The clinical~     implications of ESBLs are extremely serious and sensitive diagnostic methods are urgently~     needed to guide therapy, monitor resistance development and implement intervention~     strategies. Conventionally, detection of expression of ESBLs was based on reduction of~     ceftazidime of cefotaxime MICs by ≥ 3 two fold dilutions in the presence of clavulanic acid.~     However, the use of the above method was limited to cover only some of the bacterial~     species, including predominantly E. coli and Klebsiella spp., or tested strains which were~     all transconjugants generated in vitro. ESBLs are now reported in a growing number of genera~     other than E. coli or Klebsiella spp., and Serratia marcescens.~      Carbapenems, including ertapenem, imipenem and meropenem, are the drugs of choice used for~     severe ESBL-producing bacterial infections. Failure to detect ESBL at the presence of AmpC~     β-lactamase might result in an important clinical concern because 4th generation~     cephalosporins, which are stable to AmpC β-lactamase, is not a drug of choice for severe~     infections caused by ESBLs-producing isolates. Fluoroquinolone-resistance in ESBL-producing~     Enterobacteriacea is common. In this study, the investigators will use isolates of~     Enterobacteriacea collected from different hospitals (isolates offered by the Taiwan~     Surveillance of Antimicrobial Resistance [TSAR] program) to investigate the susceptibility~     of ertapenem and five other antimicrobial agents against ESBLs-producing Enterobacteriacea.~   "
101706|NCT01725828|"~     Routine surgery requires artificial breathing through the placement of a plastic tube into~     the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen~     to the patients during surgery. Difficulties during insertion of this tube may lead to~     serious complications and during this life-threatening crisis the only way to provide oxygen~     to the patient is by the help of a procedure called cricothyrodotomy (CTY).~      CTY is a live saving procedure that involves an incision on the patient neck at a very~     precise location called Cricothyroid Membrane (CTM). The current method of identifying this~     location is by palpation of neck cartilages by the operator. The incorrect identification of~     the CTM could lead to many complications. In certain patients such as obese or distorted~     neck features would make the identification of CTM difficult. Ultrasound (US) has improved~     the success rate of many anesthesia procedures .Its use has been described for~     identification of neck structures however, this technique of localization has not been~     validated against the gold standard which is the use of CT scan. The purpose of our study is~     to determine the precision of identifying the CTM using the US versus the conventional~     finger palpation when compared to the gold standard.~   "
101707|NCT01725815|"~     Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and~     also challenges in effectively managing these health problems. There is an urgent need to~     develop self-management strategies that allow persons with SMI to more effectively manage~     their chronic medical illnesses.~      In general populations, peer-led disease self-management interventions have been~     demonstrated to be feasible, effective, scalable, and to lead to sustainable improvements in~     self-management and health outcomes. With funding from an R34 intervention development grant~     from NIMH, the study team has developed and piloted a modified version of the most widely~     tested and used peer-led self management program, the Chronic Disease Self-Management~     Program (CDSMP), for persons with serious mental illness. Two pilot tests of this~     intervention, the Health and Recovery Peer (HARP) program, demonstrated that the program can~     be implemented with high engagement, retention, and program fidelity, and can result in~     effect sizes across a range of outcomes comparable to or greater than those seen in general~     medical populations.~      This application proposes to conduct a fully-powered, multisite trial of the HARP program. A~     total of 400 individuals with serious mental illnesses and one or more chronic medical~     condition will be recruited from three diverse community mental health clinics in the~     Atlanta metro region and randomized to the HARP program or usual care. For individuals in~     the HARP program, two peer educators with SMI and one or more chronic medical condition will~     lead a six-session, six-week manualized intervention, which helps participants become more~     effective managers of their chronic illnesses. Follow-up interviews and chart reviews at 3~     months, 6 months and one year will assess changes in clinical outcomes, improvement in~     generic and disease-specific measures of illness self-management, and quality of care.~     During the final phase of the study, a dissemination strategy building on the CDSMP training~     infrastructure will allow program participants to lead HARP groups.~      If successful, this study will establish the first fully peer-led, evidence-based~     intervention for improving physical self-management in this vulnerable population.~   "
101711|NCT01725763|"~     Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by~     pathological elevation of mean pulmonary arterial pressure (mPAP) >/= 25 mmHg at rest. mPAP~     < 20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as~     borderline PH diagnosed by right heart catheterization. Based on the etiology, PH is~     assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an~     important prognostic and therapy-deciding criterion.~      Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate~     elevated mean pulmonary arterial pressure from period of existence of a vortical motion of~     blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector~     field, particle trace and streamline representations and can be analysed with respect to~     vortex related measures (geometry of center, vortex formation, vorticity, propagation~     dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation~     scans represent promising techniques for PH characterization.~      Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in~     the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2.~     investigate the hemodynamic state of borderline PH compared to normal mPAP and manifest PH~     by non-contrast CMR.~   "
101712|NCT01725750|"~     This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing~     Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month~     follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white~     light treatment will report significant reductions in fatigue compared to individuals~     receiving dim red light treatment for the same duration of time, and that these treatment~     effects will be maintained one month after treatment completion.~   "
101713|NCT01725737|"~     Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity~     Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current~     medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.~     We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This~     study will also help us to understand the mechanism of ADHD and give a way to develop new~     drug and also a more possible way to treat ADHD children under 6 years old.~   "
101714|NCT01725724|"~     The purpose of this study is to compare the infection rate in patients receiving/not~     receiving their own blood, collected during surgery, during and after orthopedic surgery.~      The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative~     infection.~   "
101715|NCT01725711|"~     Patients with transfemoral amputations (TFA) frequently experience problems related to the~     use of socket-suspended prostheses 1-3. These problems increase with short or deformed~     stumps 4. The potential for improvement is substantial. Based on the very good long-term~     results with osseointegrated titanium implants for edentulous patients 5, osseointegrated~     hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8,~     the clinical development of osseointegrated prostheses for TFA started in 1990, in~     Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a~     prospective clinical trial began.~      The hypothesis is that the treatment will improve quality of life.~   "
101716|NCT01725698|"~     This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4,~     BMP-2, and implant in treating critical-sized bone defect.~      In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone~     will suffer a healing disturbance. In treating these conditions, the conventional method~     were vascularised bone grafting and bone transport. But the existing methods of treatment~     have many weaknesses Vascularized bone graft is a procedure with a high level of difficulty.~     Hence not every orthopaedic surgeon were able to perform it. It also takes more operating~     time and its failure rate is also quite high.~      Meanwhile, external fixation which is applied with bone transport, was being often~     complained by the patient in terms of cosmetic and psychologically.~      According to diamond concept of bone healing, there are four main factors that influence the~     bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive~     factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical~     component (implant). The potency of each component in fracture healing with/out bone defect~     has been proved in many studies. The combined effect of these components is often studied as~     well, but not in critical-sized bone defect.~   "
101717|NCT01725685|"~     This will be a randomized, double-blind, single-dose, three-period balanced crossover study~     in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment~     sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg~     and FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to~     10 days between the periods.~      The study will include a Screening period (28 days prior to first dose), Treatment period (3~     single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7~     to 14 days post last dose).~      The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed~     timepoints.~   "
101718|NCT01725672|"~     This is a an open-label, randomized, single dose, four-way crossover, multi-stage study~     enrolling 20 healthy adult male and female subjects per part. This study consists of two~     separate parts (Part A and B) with each part comprising four treatment periods. Each subject~     will participate in all four treatment periods per part; Subjects may not enrol in both~     Parts A and B.~      This study is being conducted to compare the pharmacokinetics (PK) of two extended release~     fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses,~     500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single~     dose and compared with the commercially available formulations of metformin extended release~     (XR) (GLUCOPHAGE ™ Sustained Release [SR]) and glimepiride immediate release (IR) (AMARYL~     ™).~      Part A of study will evaluate the bioavailability of a formulation comprising a film coated~     tablet containing release controlling polymers; and Part B will evaluate the bioavailability~     of a formulation comprising a tablet coated with release controlling polymers.~      In each part there will be 4 treatment periods. During each period, subjects will be~     randomized sequentially to receive a single dose of a reference treatment of 500 mg~     metformin XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg~     glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR;~     and an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR.Serial PK sampling~     for up to 36 hours and safety assessments will be performed. Each period will be separated~     by a washout period of at least 5 days and a follow-up visit will occur 14 days after the~     last dose of study drug.~   "
101721|NCT01725633|"~     This study is being done to examine the safety and feasibility of a supervised progressive~     exercise program in women diagnosed with metastatic breast cancer. Previous research among~     women with metastatic breast cancer has shown that some of the treatments commonly used in~     this population may have an adverse impact on physical fitness levels leading to feelings of~     fatigue and poor quality of life. Supervised exercise training has been shown to reduce some~     of these side-effects in women with early-stage breast cancer receiving common cancer~     treatments. However, it is not known if supervised exercise training is a safe and feasible~     intervention in women with metastatic breast cancer. This study is designed to find out if~     supervised exercise training is safe as the patients undergo treatments for metastatic~     breast cancer.~   "
101722|NCT01725620|"~     To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,~     Enbrel® 25mg.~   "
101723|NCT01725607|"~     We designed a study to determine whether a single dose of dexmedetomidine or thoracic~     epidural anesthesia combined with general anesthesia would provide hemodynamic stability,~     reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep~     quality in patients after thoracic surgery.~   "
101724|NCT01725594|"~     This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple~     ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses~     (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a~     high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.~   "
101725|NCT01725581|"~     The purpose of this study is to show that a new assessment tool for pelvic examination is~     valid and reliable.~   "
101726|NCT01725568|"~     The BioMonitor is an implantable cardiac monitor used to automatically detect and record~     episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial~     fibrillation. The study will be conducted to support regulatory approvals outside of Europe.~     This BioMonitor Master study is designed to investigate the clinical efficacy and safety of~     the BioMonitor.~   "
101727|NCT01725555|"~     This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect~     of food on the bioavailability of AXL1717 including patients with advanced malignant tumors~   "
101728|NCT01725542|"~     Evaluation of efficacy and tolerance to a QUadruple therapy with Asunaprevir , Daclatasvir,~     Ribavirin and pegylated Interferon alpha-2a, in HIV-HCV genotype 1 or 4 coinfected patients~     previously null responders to a standard Pegylated Interferon -Ribavirin regimen.~      The proportion of patients presenting cirrhosis (defined by a METAVIR F4 score on liver~     biopsy and/or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all of~     the patients included~   "
101729|NCT01725529|"~     The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as~     part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV)~     in patients with genotype 1 Hepatitis C virus (HCV) infection.~   "
101730|NCT01725516|"~     The purpose of this study is to determine whether myofascial release technique are effective~     in the treatment of low back pain due to lumbar disc herniation.~   "
101731|NCT01725503|"~     The goal of the present study is to quantify the rate of synthesis of creatine in healthy~     controls and endurance trained subjects. In addition, the effect of oral creatine supplement~     for seven days on creatine kinetics will be examined.~      Ten healthy controls (age 20-35 years) and ten endurance trained subjects will be recruited~     by advertisement. Endurance trained subjects will be recruited from health clubs. They will~     be screened for absence of any chronic disease (history, physical examination, CBC,~     metabolic and liver panel, urinalysis). A DEXA measurement will be done to quantify whole~     body skeletal muscle mass.~      For five (5) days prior to the study, they will be placed on a creatine-free (essentially~     meat-free) diet. Dietary compliance will be ensured by repeated communication with the~     subject, by nurse coordinator and the CRU Nutritionist. Subject will maintain daily record~     of the food intake for validation. On the last day, i.e. 24 hours prior to the tracer study,~     subject will collect the 24 hours urine sample and bring it to the CRU on the day of the~     study.~   "
101732|NCT01725490|"~     Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon~     and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients~     to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs~     (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal~     and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage~     and cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide,~     which is widely used for treating diabetes mellitus, has recently been suggested to have a~     suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant~     safety issues in long term use. The investigators devised a double-blind randomized~     controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in~     non-diabetic FAP patients.~   "
101733|NCT01725477|"~     1. Methylene blue in laparoscopy use for tubal patency assessment~        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and~          fertility.~        3. tubal washing after Methylene blue administration could be effective in pregnancy rate~          after operation.~   "
101734|NCT01725464|"~     During early postoperative after lung resection surgery, patients without oxygen~     supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen~     mask or cannular. In this study the investigators want to the sudy the effect of oxygen~     supplementation via oxygen cannular during the first 120 minutes after surgery~   "
101735|NCT01725451|"~     This study will evaluate the effect of deodorant and antiperspirant use and the presence of~     underarm hair on the absorption of testosterone. Each participant in this study will receive~     6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.~     There is a minimum one day washout period between each dose. This study will last~     approximately 24 days not including screening. Screening is required within 30 days prior to~     the start of the study.~   "
101749|NCT01725269|"~     The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16~     weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the~     intermediate / long-term safety of AIR001 in subjects who have completed the AIR001-CS05~     study. Assessments to evaluate the effectiveness of the study drug will include measurements~     of exercise ability and evaluations of PAH disease symptoms.~   "
101736|NCT01725438|"~     The objective of this project is to develop a non-invasive prenatal diagnostic test for~     trisomy 21 which is reliable, sensitive and cost-effective, and thus, offers an alternative~     to the currently employed invasive diagnostic tests amniocentesis and chorionic villus~     sampling.~      Current prenatal screening methods (blood markers and ultrasound) for trisomy 21 (Down~     syndrome) detect about 90 % of cases and have a false positive rate of > 90 %. The results~     of these tests are expressed in risks for trisomy 21, the threshold being in France at~     1/250. Women exhibiting a higher risk are offered to undergo invasive diagnostic testing,~     either by amniocentesis or chorionic villus sampling. However, these invasive diagnostic~     methods are associated with a considerable risk of miscarriage (1-3 %), and thus underline~     the importance to develop a safe and non-invasive prenatal diagnostic test for trisomy 21.~     The investigators have planned to assess the clinical impact of a non-invasive prenatal~     method to detect Trisomy 21 through genetic analysis of circulating trophoblastic cells.~   "
101737|NCT01725425|"~     The purpose of this study is to investigate whether different portion sizes will effect~     overall mood.~   "
101738|NCT01725412|"~     Thiamine is a key component in the creation of physiologic anti-inflammatory mediators.~     Serum thiamine stores have been found to be deficient in diabetic patients. Thiamine~     deficiency may be a key pathological mechanism of inflammation that results in diabetic~     kidney and retinal injury. The investigators hypothesize that the repletion of a patient's~     thiamine by oral supplementation may result in reduced inflammation, and therefore reduced~     kidney injury.~   "
101739|NCT01725399|"~     Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery~     and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting,~     a medicine called ondansetron (Zofran), is in dire national shortage. Consequently,~     non-pharmacological methods of prevention and treatment for post-operative nausea and~     vomiting have increased import. Following emergence from general anesthesia, children often~     request food and drink. There have been no studies to date that definitively determine the~     optimal first food or drink choice for these children. This study proposes to randomize~     children to either water or juice first intake following surgery. The investigators expect~     to find that children who consume glucose are less likely to vomit than those who first~     receive water.~   "
101740|NCT01725386|"~     This observational study will evaluate the routine clinical use and the safety and efficacy~     of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer.~     Eligible participants will be followed for up to 24 months.~   "
101741|NCT01725373|"~     In patients with unprotected left main disease (ULMD), angioplasty is emerging as an~     alternative technique. The investigators aimed to determine the rate of major cardiovascular~     events in patients treated by angioplasty for ULMD in a real world registry.~   "
101742|NCT01725360|"~     Control of airway inflammation is the cornerstone of asthma management. The aim of the~     present pilot study was to assess whether, and in which magnitude, a leukotriene receptor~     antagonist (LTRA) added to a basic treatment of inhaled corticosteroids (ICS) + long-acting~     betamimetics (LABA) might improve airway hyperresponsiveness and inflammation in~     well-controlled patients with asthma.~   "
101743|NCT01725347|"~     The Validation of a Digital Diet Method project is very innovative because it links three~     methods to address the gap in measuring food intake of HS preschool children. Data~     collection is based on EMA theory; participant burden is low, and the Food Image App~     decreases participant and staff burden even further. Data management and analysis are~     semi-automated and relies on advanced computer algorithms. A strength of this approach is~     its semi-automation, which allows us to leverage the strengths of human operators and~     computer automation.~   "
101744|NCT01725334|"~     Schizophrenia is a complex, challenging, and heterogeneous psychiatric condition, affecting~     up to 0.5% of the population and responsible for nearly 2% of all Canadian health-care~     expenditure. Much of the morbidity of the illness is related to its negative symptoms,~     including amotivation, asociality, anhedonia and flattened emotional affect, which lead to~     functional impairment and withdrawal from social and occupational domains. In contrast to~     positive symptoms, such as hallucinations and delusions, there are currently no effective~     treatments for negative symptoms, which experts recognize are largely responsible for the~     long-term disability of a majority of patients with schizophrenia. Advances in neuroscience~     have allowed a greater understanding of negative symptoms and have identified key structures~     and circuits believed to generate and maintain them. Here, we propose the application of a~     targeted therapy, deep brain stimulation, to alter the circuits driving negative symptoms.~   "
101745|NCT01725321|"~     Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the~     missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in~     the right side colon have been suggested to be the cause for interval cancer that developed~     after a prior negative colonoscopy.~      Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been~     developed to improve colonic polyp detection. However, it remains controversial whether the~     previous version of NBI helps to improve colonic polyp detection. The new generation~     colonoscope is equipped with high definition and improved narrow band imaging (NBI) which~     gives at least twice the viewable distance and contrast. The images obtained are far~     brighter with better resolution than the previous version. It however remains to be~     determined whether this enhanced imaging technique could help to improve colonic polyps~     detection.~      Hypothesis:~      The new generation NBI increases the detection rate of proximal serrated polyps and reduces~     the missed rate of all colorectal polyps.~      Aims:~        -  To determine whether the new generation NBI improve the detection rate of proximal~          serrated polyps.~        -  To determine whether the new generation NBI improve the detection rate of all~          colorectal adenoma and polyps.~        -  To determine whether the new generation NBI reduce the miss rate of colorectal adenoma~          and polyps.~   "
101746|NCT01725308|"~     In period I, the treatment effect of FK949E was compared with that of placebo in a blind~     manner in bipolar disorder patients with major depressive episodes. In period II, the~     long-term safety and efficacy of FK949E was evaluated.~   "
101747|NCT01725295|"~     Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have~     found that our patients seem to benefit from a soft tissue physical therapy called~     neurostructural integration therapy (NST). The purpose of this study was to compare NST to~     hydrotherapy which is already used to manage fibromyalgia symptoms.~   "
101750|NCT01725256|"~     The purpose of this study is to evaluate the safety and effectiveness of an~     investigational/experimental drug called AIR001.~      To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in~     the lungs and the function of the heart. This will be done by monitoring changes in~     Pulmonary Vascular Resistance (PVR); from Baseline/Day 1 (start of study drug) to Week 16 of~     the study. PVR measures the resistance to flow in the blood vessels of the lungs. The study~     will include other assessments to evaluate the effect of the study drug on PAH, including~     measurements of exercise ability and evaluations of PAH disease symptoms.~   "
101751|NCT01725243|"~     In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national~     clinical guidelines on important women's health issues, recommended that a bolus of~     carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of~     oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to~     oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the~     recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be~     used to achieve the same degree of uterine contractility with less side effects. So far, the~     ideal dose to be used in cesarean sections for labouring women who have failure to progress~     in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not~     descending the birth canal) has not been determined. This study is designed to determine the~     minimum carbetocin dose required during cesarean delivery for 'failure to progress' to~     achieve the best effect.~   "
101752|NCT01725230|"~     A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered~     alone or in combination with Fostamatinib.~   "
101753|NCT01725217|"~     To evaluate the immune response and safety following a single dose of Novartis Meningococcal~     ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.~   "
101754|NCT01725204|"~     Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors~     (TKI). However, a few patients will be cured with TKIs alone, and thus need continued~     life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate~     is higher with second generation TKIs compared with imatinib. Some experience with drug~     discontinuation in CMR has been derived from a few small studies, most notably the French~     STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log~     reduction in molecular response) can stop imatinib without relapse, indicating possible~     cure. To increase the non-relapse rate is of major importance. To achieve a permanent cure~     without stem cell transplantation is presently the most relevant goal of clinical studies in~     CML.~      The investigators hypothesize that to significantly increase cure rates in CML, therapy~     should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second~     generation TKIs may have a more profound effect on the stem cell pool as compared to~     imatinib. This is assessed in our current randomized study with a reduction in leukemic stem~     cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent~     immunomodulatory and antiproliferative mode of action, and has also activity in stem cells.~     Pegylated IFN in combination with imatinib results in improved therapy responses as compared~     to imatinib monotherapy. This advantage may translate into higher cure rates.~      Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and~     induces immunological effects that are different from those of IFN. Both of these drugs may~     have immunological adverse-effects when used as a monotherapy. However, immunological~     adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib~     and pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in~     a clinical study.~   "
101755|NCT01725191|"~     This phase I trial studies the side effects and best dose of tivantinib in treating younger~     patients with solid tumors that have returned after a period of improvement or have not~     responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
101756|NCT01725178|"~     Train The Brain is aimed at assessing the efficacy of cognitive and physical training in~     slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).~   "
101757|NCT01725165|"~     The goal of this clinical research study is to learn if surgery or radiation after~     chemotherapy can help to control NSCLC. The safety of this treatment will also be studied.~   "
101758|NCT01725152|"~     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,~     crossover study to investigate ganaxolone treatment in children with fragile x syndrome~     (FXS). Up to 60 subjects (ages 6-17 yrs) will be randomized to receive either ganaxolone or~     placebo for 6 weeks and then cross over to the opposite treatment for another 6 weeks. The~     aim of the study is assess the safety, tolerability and efficacy of ganaxolone for treatment~     of anxiety and attention in subjects with FXS. The hypothesis is that ganaxolone treatment~     compared to placebo will improve anxiety and attention as measured by the several~     neuropsychological and psychometric tests.~   "
101759|NCT01725139|"~     This is a dose escalation/dose finding, double-blind, placebo-controlled, parallel study of~     GSK2126458 in subjects with IPF. The study is designed to explore a number of doses of~     GSK2126458 for engagement of pharmacology after short term dosing. It is anticipated that~     approximately 24 subjects will be enrolled in this study. Actual number of cohorts in this~     study could vary up to a maximum of 6 cohorts (n=4/cohort; 3 on active and 1 on placebo).~      Each cohort will consist of four subjects who will be randomised to receive GSK2126458~     (three subjects) or placebo (one subject) for approximately 8 days (7 to 10 days). On Day 1~     they will receive their first dose of GSK2126458 (or placebo) and safety, tolerability and~     PK/PD in the blood will be measured for up to 8 hours post-dose. Subjects will then be~     discharged from the site with study drug until the last day of dosing. They will also~     receive hand held spirometers and instructions on action to be taken in case of~     deterioration in pulmonary function or any other adverse events (AEs). On the last day of~     dosing they will return to the site for a repeat of the Day 1 procedures.~      A bronchoalveolar lavage (BAL) and [18F]-fluoro-deoxyglucose (FDG)- positron emission~     tomography / computed tomography (PET/CT) scan will be conducted twice during the study;~     once, at least 2 days before dosing commences and again during the course of the dosing~     period.~      After the final subject in each cohort has completed dosing, a dose escalation meeting will~     take place. Safety and tolerability and PK data will be reviewed during this meeting and~     decisions made may include but are not limited to: escalate the dose, decrease the dose or~     repeat the same dose in the next cohort; stop the study.~   "
101784|NCT01724814|"~     Study Design:~      Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with~     Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1~     diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes~   "
102193|NCT01719458|"~     In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24~     obese individuals and 24 individually matched healthy control subjects and determine~     Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.~   "
101760|NCT01725126|"~     This study is the first administration of GSK2890457 in humans. The study will be conducted~     in 3 parts: - Part A (conducted at a single investigative site) will determine the safety~     and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well~     as evaluating the potential for a pharmacokinetic interaction with metformin. Part A~     consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at~     multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects~     with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B~     consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and~     Follow-up periods. - Part C (conducted at multiple sites) will determine safety,~     tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C~     consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and~     Follow-up periods.~   "
101761|NCT01725113|"~     The purpose of this non-inferiority study is to compare the safety and effectiveness of a~     mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol~     in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)~     parathyroid hormone targets.~   "
101762|NCT01725100|"~     This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study~     with incomplete wash-out in subjects with solid tumors to determine the relative~     bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared~     with standard reference formulation trametinib.~      Approximately 18 subjects will be randomized to receive either a single dose of Treatment A~     (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single~     dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B)~     followed by a 7 day incomplete wash-out period, then a single dose of the other treatment.~      Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1~     followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety~     assessments, including assessment of AEs, clinical laboratory (hematology and clinical~     chemistry) and vital signs, will be made throughout the study.~      After a subject completes the study, he or she may be eligible to enter study MEK114375, an~     open-label rollover study of trametinib (no wash-out period or follow-up visit required) and~     continue receiving trametinib. For those subjects who wish to discontinue or complete the~     current study and choose not enter the rollover study, a follow-up visit should be performed~     within 21 days after receiving the last dose of study treatment.~   "
101763|NCT01725087|"~     The purpose of this trial is to evaluate the safety and efficacy of once daily orally~     administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with~     moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days~     screening period followed by a 2-week titration period and 12-week maintenance double-blind~     treatment period and a 10-14 day safety follow up period. Patients who are eligible for the~     double-blind treatment period will be randomized to one of the following treatment groups:~     GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.~   "
101764|NCT01725074|"~     This randomized controlled trial (RCT) will examine a case management program for patients~     suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail~     consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3)~     standard care. The main objectives are to evaluate how case management and social~     interaction alone compared to standard medical care affect the primary and secondary~     outcomes: physical health, quality of life, loneliness, depression, self-efficacy, outcome~     expectancies, social support, health locus of control, lifestyle behavior, social network,~     vulnerability, intention, severity, health worries and cognitive functions.~   "
101765|NCT01725061|"~     Acute lung injury (ALI) is an often deadly form of respiratory failure caused by~     inflammation. The widespread injury to the lungs involves a build-up of fluid in the lungs~     that results in damage to the lungs and a decreased ability of the lungs to function~     properly. There is currently no specific treatment for ALI; and of the 200,000 cases~     reported in the US yearly, about 40% will die.~      Some patients may have other conditions that could change the risk of developing ALI. For~     example, it has been reported that patients who have septic shock have a lower chance of~     developing ALI if they also have diabetes mellitus (diabetes). Septic shock is a type of~     infection that causes overwhelming inflammation to occur throughout the body; it increases~     the chances that a person will develop ALI.~      The reason diabetics are less likely to develop ALI is unclear and deserves further~     investigation. The investigators believe that it may be explained by differences in the way~     certain cells that are involved in inflammation function in the lungs. The investigators~     plan on looking at the relationship between the wide-spread inflammation that occurs within~     the bodies of diabetic and non-diabetic patients with an increased chance of developing ALI~     [sepsis].~      To study this relationship, we will identify patients who fit the requirements of the study.~     The investigators will obtain blood samples and lung washings from these patients. The lung~     washings will be obtained by injecting clean salt water into the lungs through a tube and~     then pulling the water back out. When the sterile water is removed, some cells from the~     lungs also are removed and they can then be used for further lab studies. Determining how~     diabetes may change a patient's chance of developing ALI may uncover useful information that~     may help prevent or treat ALI in all patients at risk.~   "
101766|NCT01725048|"~     This is a pilot study to test the hypothesis that the antidepressants mirtazapine and~     citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.~   "
101767|NCT01725035|"~     Nonalcoholic Fatty Liver Disease (NAFLD) is becoming the most common cause of liver disease~     in pediatrics, but little is known about its pathophysiology in children. While studies in~     obese adults with hepatic steatosis have described an increased hepatic de novo lipogenesis~     (DNL) depending on the diet, there are no studies exploring the mechanisms by which excess~     hepatic triglycerides increases in obese youths, thus explaining the accompanying~     dyslipidemia and the metabolic syndrome. The central hypothesis of this study is that~     hepatic conversion of carbohydrates to lipid (DNL) is enhanced and associated with~     accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese~     youths with hepatic steatosis. The overall goal is to examine whether hepatic DNL is~     increased in obese youths with steatosis compared to matched controls without steatosis.~      Hypotheses: Hepatic conversion of carbohydrates to lipid (DNL) is enhanced and is associated~     with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese~     youths with hepatic steatosis.~   "
101785|NCT01724801|"~     EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this~     clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine~     Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient~     with EGFR-mutant non-small cell lung cancer.~   "
102849|NCT01710865|"~     The purpose of this study is to assess the effectiveness of a new hydrophilic sealant~     (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials~     (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.~   "
101768|NCT01725022|"~     The primary goal with this study is to document whether patients can maintain their normal~     bowel microbiota by staying at home compared to those who live at home but are treated in~     clinic, and those who are treated in the hospital. In addition, the investigators would~     predict that the quality of life will be higher for those patients treated at the medical~     home compared to those that stay at the hospital. The investigators also predict that the~     costs associated with this approach will be significantly lower compared to hospitalized~     patients. Finally, the investigators propose that the treatment related morbidities and~     mortality will not be different between the two groups.~   "
101769|NCT01725009|"~     To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute~     intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male~     subjects~   "
101770|NCT01724996|"~     To determine the significance of a simple bedside clinical test (chest wall tenderness) to~     exclude myocardial ischemia in different demographic groups.~   "
101771|NCT01724983|"~     Ketamine may improve recovery from bariatric surgery.~   "
101772|NCT01724970|"~     Obese people pose specific problems as far as the management of airway during surgery. The~     study aims to compare efficacy and safety of two LMA devices.~   "
101773|NCT01724957|"~     The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict~     significance of SB ostial stenosis after main vessel stenting in coronary bifurcation~     lesions.~   "
101774|NCT01724944|"~     The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian~     cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.~      Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic~     lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications~     rate), progression free interval, overall survival, recurrence pattern.~   "
101775|NCT01724931|"~     The purpose of this study is to determine whether aminopterin is effective in the treatment~     of rheumatoid arthritis (RA).~   "
101776|NCT01724918|"~     The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a~     new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram)~     rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those~     doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG~     (electrocardiogram), a test which checks for problems with the electrical activity of the~     heart.~   "
101777|NCT01724905|"~     Individuals with intellectual developmental disabilities (IDD) have obesity rates that~     exceed those in the general population, consume energy dense diets, and perform very little~     physical activity (PA). Overweight and obesity are independent risk factors for chronic~     disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the~     general population and those with IDD.~      The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged~     meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and~     vegetables (F/V) per week. The investigators will compare participants who use the SLDm with~     participants who use a reduced energy and fat diet with meal plans, based off of the current~     American Dietetic Association recommended car for weight reduction plan.~   "
101778|NCT01724892|"~     Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).~     Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has~     numerous serious complications, especially glaucoma. Loteprednol, a new generation of~     corticosteroid has less potency than dexamethasone and was proposed to has less side effect~     regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to~     compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after~     PRK and risk of glaucoma.~   "
101779|NCT01724879|"~     The current standard treatment approach for young patients with Positive Acute Lymphoblastic~     Leukemia (Ph+ALL) is the combination of a chemotherapy protocol employing four to five~     cytotoxic agents typically used for ALL together with imatinib. It is recommended to propose~     allogeneic Standard Induction and Consolidation Therapy (SCT) to all eligible patients with~     a suitable donor and to continue imatinib with or without additional therapy in patients not~     undergoing SCT.~      This protocol is a study for newly diagnosed Philadelphia chromosome positive acute~     lymphoblastic leukemia in patients aged 18 to 55 years.~      The objective of this strategy is to improve the overall results in the treatment of adult~     ALL with the addition of specific molecules to the common chemotherapeutic schedule.~   "
101780|NCT01724866|"~     The purpose of this study is to assess the effect of test doses of HM10460A on the duration~     of severe neutropenia (DSN) during Cycle 1 in patients with breast cancer who are candidates~     for adjuvant or neoadjuvant chemotherapy.~   "
101781|NCT01724853|"~     The main objective of the study is the evaluation of the outcomes following treatment for~     TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of~     the International Classification of Functioning, Disability and Health (ICF). Secondary aims~     are the analysis of the determinants of patient satisfaction with the treatment result, the~     evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),~     which has not yet been established in TMC OA patients, as well as the economic impact~     associated with TMC OA.~   "
101782|NCT01724840|"~     Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the~     use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and~     successfully used in TMC OA surgery and therefore represents an acceptable alternative for~     avoiding possible donor-site morbidity. However, there are no randomised controlled trials~     (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared.~     Only with an RCT design it is possible to gain evidence about the advantages of one~     treatment method over another. The main objective of the study is the comparison between two~     surgical techniques for TMC OA: The resection interposition suspension arthroplasty using a~     part of the flexor carpi radialis tendon as interpositional material and using the~     GraftJacket as interpositional material.~   "
101783|NCT01724827|"~     The main purpose of this trial is to determine which material, between ceramic and~     composite, is best to manufacture dental inlays and onlays in the treatment of moderate~     dental substance losses, generally due to dental caries. Restorations will be done using~     direct Computer Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to~     determine which factors influence the success of these restorations.~   "
101786|NCT01724788|"~     Primary Objective:~        -  To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral~          formulation in patients with chronic renal failure undergoing peritoneal dialysis.~      Secondary Objectives:~        -  To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral~          formulation and 250 mg IV formulation~        -  To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special)~          oral formulation and 250 mg IV formulation~   "
101787|NCT01724775|"~     In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in~     which the same principle of TME in rectal cancer has been applied to the colon. More and~     more surgeons pay attention to the rationality of this surgical approach. However, the~     clinical application researches are still few, in particular the prospective controlled~     study is still none. This clinical trial will compare the CME group and non-CME group to~     evaluate the outcome and safety of CME for apply in clinic.~   "
101788|NCT01724762|"~     This study's general objective was to evaluate the efficacy of nursing orientation to reduce~     the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific~     objectives included: the development and validation of an informative manual concerning bed~     bath; correlation of physiological variables (systolic and diastolic blood pressure and~     heart and respiratory rate) with the patients' state anxiety; correlation of antecedent~     variables (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety,~     depression, prior hospitalization, prior experience with bed baths, the patients' preference~     for a female or male professional to perform the bath, pain, fear, and embarrassment) with~     the patients' state anxiety.~   "
101789|NCT01724749|"~     The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular~     molecular calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron~     emission tomography (PET) computed tomography (CT) in a prospective cohort of healthy~     control subjects and subjects with cardiovascular disease.~   "
101790|NCT01724736|"~     This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie~     beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the~     Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones~     (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and~     satiety.~   "
101791|NCT01724723|"~     Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB~     patients, especially in those with viral hepatitis. A previous study revealed the risk of~     HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA~     level than those with low HBV DNA level. Based on these findings, we thus hypothesize that~     the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by~     concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective~     randomized clinical study to assess the reduction of HATT risk by using entecavir in TB~     patients with high baseline serum HBV DNA level, and to evaluate the risk of other~     treatment-related adverse events in two hospitals.~   "
101792|NCT01724710|"~     Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is~     major reason leading to chronic wound healing.~      The investigators's previous animal experiments have confirmed that OLED can promote burn~     wound healing and fibroblast proliferation in normal Wistar rat.~      In order to find the time point and dosage of the effective light therapy. The investigators~     further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast~     proliferation mechanisms.~      Expect clinical application of light therapy in the future is more accurate and effective.~   "
101793|NCT01724697|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end~     stage liver disease. However, lack of donors, surgical complications, rejection, and high~     cost are serious problems.~      stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte;~     Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common~     source of SCs for clinical applications.Previous study showed that bone marrow derived stem~     cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental~     liver failure and contribute to liver regeneration. In this study, the patients with~     HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via~     hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for~     these patients.~   "
101794|NCT01724684|"~     Recent studies have demonstrated the promising potential that telehealth has in management~     of chronic disease. For COPD patients, implementation of telehealth reduced readmissions,~     emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of~     delivering healthcare to remote, resource-deprived areas is not lacking in evidence of~     benefit; however, the situation about its more widespread use for monitoring purposes is~     much less clear. To date, most of the studies dealing with telehealth in COPD were conducted~     in countries covering vast territories. Therefore, it needs to be investigated whether~     telehealth conveys similar advantages for COPD patients in a small island country.~   "
101795|NCT01724671|"~     To compare the time to pathogen eradication, and the relationship to the time to clinical~     improvement, between ceftaroline and case-matched vancomycin treated controls in the~     treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus~     aureus (MRSA).~   "
101796|NCT01724658|"~     Additional testosterone undecanoate can improve female sexual function in postmenopausal~     women which one aspects of quality of life. The dose adjustment can reduce incidence of~     adverse effects and low cost of treatment with effective outcome.~   "
101797|NCT01724645|"~     This trial is being conducted to look for following changes when Korean traditional diets is~     taken in subjects with hypertension and type 2 diabetes:~      To evaluate the improvement of the controlling fasting blood glucose and glycated~     hemoglobin.~      To assess the controlling blood pressure and heart rate.~      To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High~     Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.~      To evaluate the influence on Gamma-Glutamyl Transpeptidase.~      To evaluate the influence on Cardiovascular risk factor.~      To evaluate the influence on valsava score, breathing score and upright score.~   "
101798|NCT01724632|"~     The purpose of this study is to compare three methods of delivering behavioral weight loss~     treatment.Participants are randomly assigned to one of three 18-month weight loss treatments~     (group, individual, or smartphone treatment). Participants who are assigned to group~     treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6~     months, and then monthly for the final 6 months. Participants who are assigned to individual~     treatment will attend one-on-one sessions with a weight loss counselor every month for 18~     months. Participants who are assigned to smartphone treatment will use a smartphone to learn~     and practice weight loss skills. They will also attend one-on-one sessions with a weight~     loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6,~     12, and 18 months.~   "
101799|NCT01724619|"~     Prostate cancer represents a significant health problem in the United States. This year~     179,000 men in the United States will be diagnosed with prostate carcinoma and approximately~     25% of them will die of the disease. In addition, the incidence and mortality of prostate~     carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA)~     levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless,~     there is a significant false negative and false positive diagnosis since PSA levels elevate~     in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications~     and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels~     within the normal range, thus confounding the diagnosis based on the PSA screening test.~     Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided~     prostate biopsy are logistically difficult and insensitive. These are further complicated by~     equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or~     normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer~     related structures at a cellular level would enhance our understanding of the~     pathophysiology of prostate cancer and would contribute to the detection, localization and~     quantification of the disease and its metastases. This information will be invaluable in~     selecting the appropriate treatment regimen.~      This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate~     if this radiotracer can differentiate primary prostate cancer in the prostate gland from~     normal prostate gland itself. More specifically, we will study the distribution kinetics of~     [F-18]FMDHT in normal healthy humans and in patients with prostate cancer.~      As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an~     outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A.~      Based on our and others data, we hypothesize that:~        1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood~          flow pattern and will clear rapidly from tissues with no AR.~        2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.~        3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions~          compared to surrounding normal prostate.~      In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human'~     biodistribution study in subjects with and without prostate cancer.~   "
101800|NCT01724606|"~     Sorafenib is a new type of anti-cancer drug. It belongs to a new class of medications known~     as tyrosine kinase inhibitors. Sorafenib is thought to work against cancer in many ways. It~     helps decrease blood supply to the tumor. It also blocks some proteins that help the tumor~     cells to grow. Sorafenib is approved by the Food and Drug administration (FDA) for~     treatment for other cancers like liver and kidney cancer. Sorafenib has also been studied in~     the treatment of breast cancer that has spread but is not specifically approved for the~     treatment of breast cancer. It has been studied both as a single agent and also in~     combination with other anti-cancer therapies for breast cancer. In laboratory models and in~     some patients with other cancers, sorafenib has been studied in tumors in the brain.~      In this study, sorafenib will be given together with whole brain radiation therapy (WBRT).~     Overall this research study is designed to answer 2 main questions:~        1. What dose of sorafenib should be used together with WBRT?~        2. What are the side effects of sorafenib and WBRT when given together?~   "
101801|NCT01724593|"~     Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and~     preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW~     is associated with increased mortality and length of stay, and negatively impacts long-term~     functional outcomes and quality of life in affected patients and their caregivers. While~     delayed mobilization adversely affects clinical outcomes, early rehabilitation in the~     critically ill adult population is safe, feasible, cost effective, results in more~     ventilator free-days and better functional outcomes at hospital discharge. In contrast,~     there is a paucity of this research in pediatrics. Our research suggests that immobilization~     is common in critically ill children, and rehabilitation is delayed particularly in the~     sickest children who are arguably at highest risk of morbidity. It is unclear however,~     whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has~     been demonstrated in adults. Our objectives of this study are to evaluate if immobilization~     and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to~     functional recovery in critically ill children. The investigators hypothesize that the~     following factors may influence functional recovery and morbidity in critically ill~     children:~        -  Pre-morbid condition~        -  Age~        -  Time-to-initiation of acute rehabilitation~        -  Critical illness disease severity~   "
101802|NCT01724580|"~     The Requesting Physician/Investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the expanded access program.~   "
101803|NCT01724567|"~     The purpose of the study is to make a head-to-head comparison of weight loss and interval~     training as methods of secondary prevention in overweight patients with ischemic heart~     disease.~   "
101804|NCT01724554|"~     The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal~     Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or~     Proliferative Diabetic Retinopathy (PDR).~   "
101805|NCT01724528|"~     The purpose of this study is to determine whether febuxostat is superior to allopurinol in~     the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at~     intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo~     chemotherapy~   "
101806|NCT01724515|"~     The purpose of this study is determine if you have too much fat in your body that it will~     decrease the conversion of food energy into energy that your body can use.~   "
101807|NCT01724502|"~     The purpose of this study is to determine whether insulin resistance is accompanied by~     exercise resistance. Investigators will use mass spectrometry and proteomics analysis to~     test the hypothesis is that a bout of exercise that increases mitochondrial protein~     abundance in lean, healthy individuals is less effective in insulin resistant patients.~   "
101916|NCT01723085|"~     Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian~     surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other~     surgeries. We seek to investigate the hormone variations before and after an open~     myomectomy.~      Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels~     in a few months~   "
102850|NCT01710852|"~     The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF~     (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF~   "
101808|NCT01724489|"~     Obesity is an important risk factor for osteoporosis and fractures. With the growing~     prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this~     population is of importance to public health. Growth hormone (GH) is a critical mediator of~     bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an~     important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of~     bone loss in obesity. The development of novel imaging techniques provides an opportunity to~     investigate the effects of GH on skeletal structure and strength, which will provide~     insights into the pathogenesis of obesity related bone loss. Understanding the~     pathophysiology of bone loss in obesity may help identify new treatment targets for this~     important complication. The investigator hypothesizes that low-dose GH administration for 18~     months will improve skeletal health.~   "
101809|NCT01724476|"~     The investigators propose to conduct a randomized Sequential Parallel Design for~     Double-Blind Phase fixed dose, 4-month trial of folate plus B12 as add-on therapy in 200~     Ethiopian subjects with schizophrenia with stable residual positive or negative symptoms.~   "
101810|NCT01724463|"~     Thousands of children die from Sepsis following routine infections. Many of these deaths can~     be prevented with earlier recognition and focused management. No tools are currently~     available to recognize the signs of early sepsis in children. The investigators have~     developed a electronic health record-based tool that will recognize children with sepsis~     early and trigger an alert to their hospital caregivers. The caregivers will be prompted to~     launch a focused management bundle that can stabilize these children, prevent further~     deterioration and reduce their chances of sepsis related complications and death. The~     proposed study will test the validity and effectiveness of this electronic tool in reducing~     sepsis mortality rates.~   "
101811|NCT01724450|"~     The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after~     chemotherapy in breast cancer.~   "
101812|NCT01724437|"~     The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein~     isolation using a standard approach compared to application of an additional acute~     procedural endpoint of unexcitability along the ablation line.~   "
101813|NCT01724424|"~     Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation,~     mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria~     and both it and its metabolites have potent antioxidant and anti-inflammatory activity,~     preventing organ dysfunction in a rat model of sepsis. The investigators propose a study in~     healthy volunteers to assess the tolerability and pharmacokinetics of exogenous melatonin~     and its major metabolites and to relate these doses to ex vivo anti-inflammatory and~     antioxidant activities. Groups of healthy subjects will receive increasing sequential doses~     of oral melatonin in an open label dose escalation study. Ex vivo inflammatory responses,~     oxidative stress and mitochondrial function at concentrations of melatonin identified in the~     dose escalation study will be determined following exposure of whole blood to an~     inflammatory insult. This will provide crucial information to inform a subsequent phase II~     clinical trial of melatonin in patients with sepsis.~   "
101814|NCT01724411|"~     The proposed study will address the effect of developed novel food products through~     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability~     and gut health using in vivo studies and validating new in vivo approaches.~      Specifically in this protocol we will address, in a short human intervention study the~     effect of a potentially satiating product on appetite, appetite biomarkers, particularly the~     influence on gut microbiota, tolerance and safety of the products in healthy obese and~     overweight volunteers in free living conditions.~   "
101815|NCT01724398|"~     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells.~     Although liver transplantation provides an option to cure patients suffering with LF, lack~     of donors, postoperative complications, especially rejection, and high cost limit its~     application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs)~     the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured~     liver, and effectively rescue experimental liver failure and contribute to liver~     regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin,~     it helps the liver regeneration and functional recovery and make UC-MSC differentiation into~     hepatocyte like cells, and exert immunomodulatory function. In this study, safety and~     efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined~     with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will~     be evaluated.~   "
101816|NCT01724385|"~     To evaluate the efficacy of intravitreal bevacizumab injections for treatment of~     proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after~     previous full panretinal photocoagulation (PRP).~   "
101817|NCT01724372|"~     This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with~     the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at~     risk for developing psychosis.~      Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better~     tolerated and will lead to greater improvement in symptoms at the end of 6 months of~     treatment.~   "
101818|NCT01724359|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,~     once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from~     Argentina and Colombia that previously failed treatment with other antipsychotic agents.~   "
101819|NCT01724346|"~     An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic~     Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA~     (PCI-32765 versus Chlorambucil)~   "
101844|NCT01724021|"~     This multi-center, open-label, randomized study will evaluate the participant preference~     with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in~     participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's~     lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)~     on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,~     followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive~     MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8~     cycles of standard chemotherapy (according to local country practice) with 8 cycles of~     MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.~   "
101820|NCT01724333|"~     Assessment of oral and dental problems is seldom routine in clinical oncology, despite the~     potential negative impact of these problems on nutritional status, social function and~     quality of life (QoL). A brief, assessment tool for oral/dental health and related~     QoL-issues to improve symptom management has been requested. The present study will be~     conducted on behalf of and with support from the European Organisation for Research and~     Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV,~     the final step, in the development of an international, symptom specific questionnaire~     module, focusing on oral and dental problems in relation to cancer and its treatment. Phase~     I-III of this stepwise development process was conducted from 2008 to 2011, as an~     international collaboration and conducted according to the guidelines for module development~     set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an~     international field testing and validation study as described in this project description.~      The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item~     scales (pain/discomfort, xerostomia, eating and information) and three single items related~     to use of dentures and future worries. The aim of the present study is to conduct phase IV;~     an international field study to confirm the psychometric properties of the QLQ-OH17~   "
101821|NCT01724320|"~     The purpose of this study is to determine the recommended dose (RD) for further phase II~     studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced~     solid tumors~   "
101822|NCT01724307|"~     The purpose of this study is to evaluate if stimulating the nerve involved with airway~     constriction, while undergoing procedures that are known to cause asthma exacerbations,~     decreases the level of asthma attack experienced.~   "
101823|NCT01724294|"~     This multicenter, observational study will evaluate the correlation between clinical and~     biological factors and International Prognostic Index (IPI) as prognostic factors in~     patients with diffuse large B-cell lymphoma receiving first-line treatment with~     MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients~     receiving treatment according to standard of care and local guidelines will be followed for~     the duration of treatment (approximately 8 months) and during 1 year of follow-up.~   "
101824|NCT01724281|"~     The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd~     trimester of normal width and asymetry of lateral brain ventricles~   "
101825|NCT01724268|"~     Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of~     adding one of the available anti TNF in the treatment of methotrexate inadequate responder~     rheumatoid arthritis patient.~      Hypothesis:~      Methotrexate + Prednisolone vs. Methotrexate + anti TNF~   "
101826|NCT01724255|"~     The medical literature does not provide sufficient information or recommendation regarding~     the optimal time to remove the staples and the bandage after a cesarean section. The goal of~     this study is to compare 5 groups of patients:~        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1~        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4~        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1~        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7~        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7~      Since there is no definite protocol for staple and dressing removal, we will adapt the above~     protocol each for a 3-4 month period of time. Patients will be contacted to either return~     for a follow up visit or to answer a telephone survey.~   "
101827|NCT01724242|"~     There does not appear to be a consensus regarding the treatment of vaginal dryness in women~     who have a contraindication to the use of estrogen products. DHEA, when used locally, may~     improve the symptoms of vaginal dryness due to its chemical properties.~   "
101828|NCT01724229|"~     The purpose of this evaluation is to observe the performance of two (2) different skin care~     treatment protocols on the skin:~      #1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2~     Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.~      The scientific evidence supports using these types of skin care products to keep the skin~     healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are~     preferred over soap and water and can be applied on all areas of the skin. The Moisture~     Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The~     Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock~     itch, and ring worm to relieve itching, soreness, and irritation.~   "
101829|NCT01724216|"~     The purpose of the study is to collect in vivo human image data to demonstrate neurological~     magnetic resonance imaging (MRI) of subjects using short pulse sequences.~   "
101830|NCT01724203|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week~     probiotic supplementation on the incidence and duration of infectious episodes in infants~     aged 6 to 12 months.~   "
101831|NCT01724190|"~     The purpose of this study is to determine if supplementation with Vitamin D in children and~     adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter~     the honeymoon period.~   "
101832|NCT01724177|"~     To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma~     (ATL) who have previously received chemotherapy for ATL.~   "
101833|NCT01724164|"~     The purpose of this proposal is 1) to compare the relative effects of the robotic~     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare~     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and~     the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will~     potentially influence the functional outcomes after interventions.~   "
101845|NCT01724008|"~     A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site~     study in subjects with at least two sensitive teeth to compare the efficacy of a test~     dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity~   "
101846|NCT01723995|"~     This study aims to evaluate the effect of low-level laser in pain relief and tissue repair~     in mothers with nipple trauma during breastfeeding, compared to a control group.~   "
101847|NCT01723982|"~     This trial investigates the effects of FE 200440 compared to placebo on implantation rate in~     women undergoing IVF/ICSI treatment~   "
101917|NCT01723072|"~     This study will assess the impact of omalizumab on the quality of life improvement when~     added to the standard therapy in refractory patients suffering from chronic spontaneous~     urticaria and angioedema.~   "
101834|NCT01724151|"~     The proposes of this study are~        1. To understand the physical activities of patients with cognitive impairment in Taiwan~          and construct the validity and reliability of the physical activity questionnaire and~          actigram in this population.~        2. To understand the relation between brain structure (brain tractography and resting~          state functional MRI) and cognitive and physical functions of patients with cognitive~          impairment, the capability of activity and social engagement (including quality of~          life).~        3. To understand the efficacy of exercise on the brain structure (brain tractography and~          resting state functional MRI), cognitive and physical functions, the capability of~          activity and social engagement (including quality of life) of the patients with~          cognitive impairment.~      The study aims to establish the data base of physical activity of patients with cognitive~     impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on~     physical function, physical activity and social engagements to provide an optimized design~     of exercise program for patients with cognitive impairment in the future.~   "
101835|NCT01724138|"~     To characterize the PK of deferasirox in pediatric β-thalassemia major patients aged from 2~     to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.~   "
101836|NCT01724125|"~     Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by~     shifting the ownership and locus of health records from being scattered across multiple~     providers to an approach that is longitudinal and patient-centered. Given the complex health~     needs and the fragmentation of care for persons with serious mental illnesses, these~     individuals could derive particular benefit from a PHR. However, there are currently no~     established PHRs developed for use in this population.~      In order to fill this gap, the investigators propose to develop, test, and disseminate a~     Personal Health Record for persons with serious mental illnesses and one or more comorbid~     medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health~     record which was developed in partnership with medical consumers and is in wide use in a~     number of communities in the United States and abroad.~   "
101837|NCT01724112|"~     This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)~     once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.~   "
101838|NCT01724099|"~     The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a~     superior reduction compared to those taking the placebo.~   "
101839|NCT01724086|"~     The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and~     low-dose ritonavir, administered together with and without ribavirin and of TMC647055,~     TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a~     limited number of patients with chronic hepatitis C virus (HCV) infection.~   "
101840|NCT01724073|"~     A food-to-food fortification strategy has been designed based on traditional foods of~     Burkina Faso to fight against micronutrient deficiencies in young children. Leafy vegetable~     sauces were formulated to improve their micronutrient contents and bioavailability. This~     efficacy study was designed to assess the effects of the regular consumption (one meal per~     day, 6 days per week) of these leafy-vegetable sauces enriched or not with liver on iron,~     zinc and vitamin A status, growth and morbidity of young children from poor urban districts~     of Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432~     12-15 month-old children will be recruited and randomly assigned to one of the four~     following arms: three intervention groups, the two first receiving leafy vegetable sauce,~     the third one receiving one meal made of the fortified Misola gruel. In these three arms,~     blood samples will be collected at the beginning and at the end of the study. The fourth arm~     is an external control group and will not receive any food. In this fourth arm, blood~     samples will be collected only at the end of the study. Biochemical indicators of~     micronutrient status will be determined, and anthropometric data will be collected in all~     children. Morbidity will also be assessed in children of intervention groups.~   "
101841|NCT01724060|"~     Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden~     both for patients and health systems alike. The surgical and medical treatments available~     for these conditions have improved significantly in the last two decades. The investigators~     do not however know how these treatments compare to each other and how they act in the body~     to cause weight loss and diabetes improvements. The studies of this experiment are~     complementary to each other. They aim to answer related questions and will allow us to study~     how these treatments work and eventually develop safer and more effective therapies for~     obesity and diabetes.~   "
101842|NCT01724047|"~     The primary goal of this study is to identify efficacious and cost effective intervention~     strategies that can improve academic and psychological outcomes for children with ASD, and~     can be feasibly be implemented at fidelity by school personnel in under served elementary~     schools. Two simultaneous interventions will occur.~      In intervention 1, students with ASD in inclusion classrooms will be randomized to the~     Playground Intervention or a waitlist control group. In the Playground Intervention,~     UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to~     increase peer engagement on the yard.~      In intervention 2, students in special day classes will be randomized to the 'Schedule Tools~     Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention,~     UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the~     classrooms.~      In both interventions, the conditions are: 1) Immediate treatment, where the training will~     begin immediately after baseline measures are completed. 2) Wait-list treatment, where the~     training will begin the follow school year.~   "
101843|NCT01724034|"~     Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean~     adult patients. In this randomized trial, standardized lung ultrasound will be performed~     daily asssociated with standardized interventions aiming to decrease the total time in~     mechanical ventilation.~   "
101861|NCT01723800|"~     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when~     given together with carboplatin and pemetrexed disodium in treating patients with stage IV~     non-small cell lung cancer. PI3K inhibitor BKM120 and pemetrexed disodium may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120,~     carboplatin, and pemetrexed disodium together may kill more tumor cells~   "
101848|NCT01723969|"~     The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a~     European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this~     screening platform is to provide quick access to new drugs to patients by offering a new~     structure for clinical trials.~      Currently some of the most challenging clinical questions arise from the molecular~     sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways~     in the patients.~      A major problem for trials in this personalized medicine is that the low frequency of the~     different mutations requires a high effort for screening and identifying the patients.~      The EORTC CRC screening platform will hopefully offer a feasible and efficient way to~     characterize the patients on the molecular basis of their tumors and allow to offer them~     rapid and preferential participation in clinical studies with new drugs targeted to their~     specific pathway alterations.~   "
101849|NCT01723956|"~     To compare the efficacy of cryotherapy and large loop excision of the transformation zone~     (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia~     (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.~      Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV~     positive women in South Africa~   "
101850|NCT01723943|"~     This randomized clinical trial studies educational counseling in improving communication and~     quality of life in spouses and breast cancer patients. An outpatient education and behavior~     skills training program may help spouses and patients with breast cancer communicate better~     and improve quality of life. It is not yet known whether educational counseling is more~     effective than an educational booklet in improving communication and quality of life.~   "
101851|NCT01723930|"~     Get a better understanding of the pathophysiological processes of acute respiratory failure~     following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.~      Demonstrate that there is a relationship between increased transpulmonary gradients of~     inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance~     on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery~     under cardiopulmonary bypass.~   "
101852|NCT01723917|"~     The purpose of this study is to evaluate the safety and efficacy of a soy based dietary~     supplement (phytoSERM) for hot flashes and age associated memory loss.~   "
101853|NCT01723904|"~     This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low~     doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)~     who have insufficient response to L-dopa and low doses dopamine receptor agonists.~   "
101854|NCT01723891|"~     Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01~     after oral administration for one day in healthy male volunteer.~   "
101855|NCT01723878|"~     This observational study will evaluate the patterns of disease progression in patients with~     locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating~     mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed~     for up to 12 months after progression of disease.~   "
101856|NCT01723865|"~     This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients~     with heart failure having an ICD-CRT implanted.~      Study purpose The purpose of this study is to test the hypothesis that the monitoring of~     specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical~     course of patients with heart failure.~      Study design This is a prospective observational study, comparing clinical course of~     patients with heart failure having an ICD-CRT implanted, followed or not by remote~     monitoring. This study will include 870 subjects with ICD and CRT-D, and followed by a~     remote monitoring system (with or without weight and pressure external sensors) or followed~     by conventional ambulatory visits.~      Primary endpoints The primary endpoint of this study is to document no superiority of~     unplanned hospital access for cardiac reasons (included access to the emergency units ) or~     death for cardiovascular causes in remote monitoring group (with or without weight and~     pressure external sensors) compared to conventional follow-up (usual care group).~   "
101857|NCT01723852|"~     The study is a randomized, controlled, double blinded study evaluating the effect of~     recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2~     years of age, on growth, bone development, neurologic and cognitive development, frequence~     of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2~     years of age.~   "
101858|NCT01723839|"~     In previously-untreated subjects with CLL, fludarabine and rituximab with or without~     cyclophosphamide (FR or FCR) produces complete responses (CR) of 40-80%. The major~     complication of FCR has been grade 3/4 neutropenia which was reduced using a lower dose of~     fludarabine and cyclophosphamide (FCR-Lite) The objective of this study is to evaluate the~     minimal residual disease (MRD) complete response rate (using the 2008 IWCLL guidelines)~     after 4 cycles of FCR-Lite plus lenalidomide in subjects with previously untreated CLL.~     Lenalidomide is active in frontline treatment of CLL as well as in patients with refractory~     disease. MRD has been demonstrated to be a sensitive surrogate marker for progression-free~     survival. If patients are MRD negative complete responders (CR) they will stop at 4 cycles~     of FCR-Lite followed by the lenalidomide consolidation/maintenance arm of the study. If they~     have a MRD positive CR or partial response (PR) they will continue with 2 additional cycles~     of FCR-Lite plus lenalidomide followed by lenalidomide consolidation/maintenance. They will~     be re-tested for MRD after the 6th cycle of FCR-Lite and after 6 and 12 months of~     lenalidomide monotherapy If they have no response (NR) or progressive disease (PD) following~     4 cycles of FCR-Lite plus lenalidomide they will be removed from the study.~   "
101859|NCT01723826|"~     This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term~     safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's~     disease who have participated in and completed the treatment period of the Phase II Study~     ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study~     ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time~     on study treatment is 144 weeks.~   "
101860|NCT01723813|"~     The purpose of this study is to determine whether the intravenous and/or GM-CT-01~     administration can correct Tumor Infiltrating Lymphocytes (TIL) anergy and induce a more~     efficient and long-lasting anti-tumoral immune response following peptide vaccination.~   "
101862|NCT01723787|"~     Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often~     catastrophic developmental consequences, is known in some patients to have many different~     genetic, metabolic and structural etiologies. However, for most patients IIS is the only~     presenting clinical feature and the specific cause is unknown. Only two FDA approved~     pharmacologic treatments for IIS exist, Adrenocorticotropic hormone (ACTH) and vigabatrin.~     While vigabatrin may be the treatment of choice for Tuberous Sclerosis as a cause for IS,~     ACTH is the treatment of choice for all others. Unfortunately, a substantial number of~     patients may still not respond to ACTH and there is no a priori way that suggests which~     patients may be responders. This has led to the following key questions:~      Can novel genetic analyses determine known genetic causes of IS with greater efficiency~     (more timely and cost-effective)? Can novel genetic analyses determine previously unknown~     disease modifying genes that predispose individuals to develop IS? Can novel genetic~     analyses elaborate genes and gene polymorphisms that favor ACTH responsiveness? Do these~     polymorphisms suggest strategies to improve ACTH responsiveness?~   "
101863|NCT01723774|"~     A Phase II study to investigate the potential utility of PD 0332991 in the treatment of~     early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to~     investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the~     pathologic complete response rate when compared to the historical control of single agent~     aromatase inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to~     historical control.~   "
101864|NCT01723761|"~     It is a clinical, observational study to evaluate the correlations among arrhythmias,~     climatic variables and air pollution in patients with pacemaker and implantable~     defibrillator (ICD), followed by remote monitoring.~      Purpose of the Study: The purpose of this study is to test the hypothesis that changes in~     climatic variables, such as temperature, pressure and humidity, and changes of particulate~     matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),~     sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of~     supraventricular and ventricular arrhythmias.~      Objectives: The aim of this study is to determine whether changes in variables conditions~     affect the electrical stability of the myocardium in patients with pacemakers and ICDs.~      Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber~     pacemaker, ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology~     centers of the Veneto region will be included.~   "
101865|NCT01723748|"~     The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often~     results in a concomitant suppression of the insulin secretion, which might lead to~     clinically significant glucose intolerance. Secondly, the traditional evaluation of disease~     activity by measuring circulating levels of GH and total IGF-I is not reliable enough~      Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:~        -  Glucose intolerance despite normalized insulin sensitivity~        -  Modified peripheral GH activity in peripheral target organs assessed on molecular~          endpoints~   "
101866|NCT01723735|"~     Primary Objective:~      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either~     alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol~     (LDL-C).~      Secondary Objectives:~        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top~          of ezetimibe or fenofibrate, based on other lipid parameters.~        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top~          of ezetimibe or fenofibrate.~   "
101867|NCT01723722|"~     This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs~     for the difference in the length of treatment. This is a randomized, open-label comparison~     of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium~     (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.~   "
101868|NCT01723709|"~     The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis~     into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort~     study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire~     administered by a trained study coordinator which is designed to collect information on the~     participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic~     explanations for response to treatment, progression of the disease, and biomarker~     validation.~   "
101869|NCT01723696|"~     Vitamin C supplementation (500 mg per day) given to pregnant women who can not quit smoking~     will improve the pulmonary function tests in their offspring measured at 3 months of age.~   "
101870|NCT01723683|"~     There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD~     since the development of Surfactant therapy. A policy of intubation with surfactant~     administration and mechanical ventilation has become a standard therapy of infants at high~     risk of RDS. However, initial stabilization with CPAP and, if necessary, given rescue~     surfactant therapy has remained the standard therapy for preterm infants. Evidence reveals~     similar results with regard to mortality and neonatal morbidity between the above two~     strategies. The investigators intend to develop a method of minimally invasive surfactant~     therapy followed by early CPAP (MISTCPAP) in preterm Infants with high risk of RDS for~     improving the outcomes and reducing the incidence of BPD.~   "
101871|NCT01723670|"~     To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up~     to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive~     impairment.~   "
101872|NCT01723657|"~     The AML-03 regimen investigates the addition of G-CSF priming to both induction and~     consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793)~     refines risk-stratification based on biological characterization also the AML-03 trial~     incorporates novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™~     in vivo purging in autografts, extends unrelated volunteers donors for allotransplants in~     high-risk patients, and introduces reduced intensity conditioning in patients with elder age~     (more than 50 years old).~      The aims of these modifications are to analyse eficacy and toxicity of this induction and~     consolidation therapy and to analyse the disease free survival in patients who achieved~     complete response following a risk adjusted therapy.~   "
101904|NCT01723241|"~     This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when~     applied to the skin of healthy volunteers.~   "
101873|NCT01723644|"~     CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial~     including adult patients admitted in the emergency department with community-acquired~     pneumonia. The objective of this clinical trial is to compare two strategies: clinical~     reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with~     community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is~     systematically started in the emergency department. The continuation, the discontinuation or~     the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and~     Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is~     diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and~     to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to~     evaluate the possibility to stop the current antibiotherapy based on criteria for clinical~     stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart~     rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg,~     Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm,~     initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship~     based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the~     clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all~     persistently sick and hospitalized patients in who antibiotic are withheld. The PCT~     algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately~     life-threatening disease. If the algorithm is overruled and antibiotics are given, an early~     discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on~     PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are~     reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs~     defined above.~   "
101874|NCT01723631|"~     The objective of this project is to characterize the response TRAP positive patients with~     Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in~     order to develop a second time as a diagnostic tool in this disease. We plan to analyze the~     response TRAP over a hundred patients with various clinical stages SEP (relapsing,~     progressive forms) and compared to healthy controls,~   "
101875|NCT01723618|"~     The purpose of the study is to determine the plasma levels of CRD007 in patients with~     abdominal aortic aneurysms after the administration of single doses of tablets containing~     10, 25 and 40 mg CRD007.~   "
101876|NCT01723605|"~     Two types of uterine repair described during cesarean section, the investigators will try to~     compare between the two techniques.~   "
101877|NCT01723592|"~     The aim of this study is the improvement of the vaginal flora by at least two grades of the~     Nugent scale after application of oral probiotics.~   "
101878|NCT01723579|"~     This study will investigate the efficacy and safety of the monophasic~      combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in~      healthy fertile Indian women.~   "
101879|NCT01723566|"~     Understanding the clinical practice of treatment of cardiac rhythm disorders all over the~     world and understanding the clinical outcomes of the treatment with its cardiac rhythm~     products in real world patient population is essential for Medtronic to be able to~     effectively develop new products and adjust existing products. In addition Medtronic is~     committed to monitor the safety of its products throughout the entire life cycle to ensure~     maximum product reliability.~      The Panorama 2 registry will enable Medtronic to increase data collection of clinical~     practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in~     various regions across the world and on product reliability of its CRDM devices.~   "
101880|NCT01723553|"~     The study is designed to assess the demographic, clinical and imaging associations with the~     presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that~     cognitive and functional performance will be poorer in atypical Alzheimer's subjects with~     microbleeds compared to those without microbleeds.~   "
101881|NCT01723540|"~     Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and~     therefore we investigate here the contributions of UsD in early recovery.~   "
101882|NCT01723527|"~     More Americans are arrested for drug offenses than for any other crime. In 2009, over~     294,000 arrests were made for possession of cocaine or heroin. Incarceration does not~     address the root problems and is frequently followed by relapse and re-arrest after release.~     In the case of opiate-dependent adults arrested for possession of heroin, one potentially~     effective alternative is to divert offenders to methadone maintenance treatment (MMT) as an~     alternative to adjudication of their case. MMT is an effective treatment for heroin~     dependence, and appears very effective for criminal offenders. However, cocaine use is~     common in MMT patients, including those with recent criminal justice involvement, and MMT~     alone is ineffective in addressing cocaine use. Continued cocaine use carries a substantial~     health burden and necessarily entails continued criminal activity. Thus, treatment for~     diverted opiate-dependent offenders should be designed to address cocaine use as well as~     opiate use. A Stage 1 Behavior Therapy Development project is planned over 2 years to adapt,~     manualize and pilot test the Therapeutic Workplace intervention for adults charged with~     heroin possession and offered diversion to methadone maintenance treatment as an alternative~     to adjudication of their case. The Therapeutic Workplace is a novel, employment-based~     contingency management intervention that has been very effective in promoting cocaine~     abstinence in adults who use cocaine persistently during methadone treatment. In the~     Therapeutic Workplace, participants are hired in a model workplace and required to provide~     drug-free urine samples to work and to earn maximum pay. Once we develop and manualize the~     adapted version of the Therapeutic Workplace for adults arrested for heroin possession, a~     pilot test will be conducted. Individuals identified by the State Attorney's office as~     candidates for diversion will be assessed for study eligibility. Given the high rates of~     injection drug use and injection-related transmission of HIV in Baltimore, this study will~     be restricted to injection drug users to evaluate the potential utility of this intervention~     in reducing HIV risk. Eligible individuals will be offered methadone maintenance in lieu of~     prosecution and will be required to remain in methadone treatment for 90 days. All~     participants will receive standard MMT, independent of whether they decide to participate in~     the pilot study. After beginning MMT, participants will be invited to enroll in the pilot~     study and randomly assigned to two study groups. Participants assigned to the Usual Care~     Diversion group will receive the standard MMT. Participants assigned to the Therapeutic~     Workplace Enhanced Diversion group will receive the standard MMT and the Therapeutic~     Workplace intervention. The data from this pilot study will serve as the foundation for a~     full-scaled randomized controlled trial. Overall, the Therapeutic Workplace could serve as a~     novel and ideal intervention for many heroin dependent adults involved in the criminal~     justice system. The use of MMT in lieu of adjudication in combination with the Therapeutic~     Workplace could increase drug abstinence and employment and decrease HIV risk and criminal~     activity in this refractory high-risk population.~   "
101883|NCT01723514|"~     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated~     in healthy subjects and migraine patients. As part of the secondary objectives, this study~     will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple~     SC doses in healthy subjects and migraine patients, as well as to characterize the effect of~     AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in~     healthy subjects and migraine patients.~   "
101884|NCT01723501|"~     Purpose of this study is determine if skin application of chlorhexidine at birth would~     reduce infection in infants weighing <1500 g at birth.~   "
101885|NCT01723488|"~     [F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the~     human brain.~   "
101886|NCT01723475|"~     This is the first study where BAY2010112 is given to humans. Patients with castration~     resistant prostate cancer will be treated. Every patient will receive drug treatment, there~     is no placebo group. Patients will receive different dosages of BAY2010112 to determine the~     safety, tolerability and maximum tolerated dose (MTD) of BAY2010112.~      The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112.~      BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous~     infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which~     the patient cannot tolerate, occur or if the patient decides to exit treatment.~   "
101887|NCT01723462|"~     Clinical pharmacy has played a role in Emergency Departments (ED). The presence of~     pharmacists have been shown to reduce medication errors and improve the medication history~     taken at admission. In Denmark a recent study revealed that clinical pharmacists identified~     medication problems in 25% of all admission to the ED, of which 47 % were considered to be~     serious.~      However, the pharmacist recommendations are of little value if they are not acknowledged or~     followed by the physicians.~      The aim of the present study was to analyze how often and under which circumstances the~     physicians made use of pharmaceutical recommendations in an ED with a mixed patient~     population with special attention to those recommendations, which were of significant or~     disastrous importance.~   "
101888|NCT01723449|"~     In Demark acutely admitted patients are supposed to stay in the Emergency Department (ED)~     bed ward if the anticipated duration of stay is less than 48 hours.~      However, it is not a trivial matter to estimate duration of stay for emergency patients. a~     number of factors affect this, eg. social background, disease, hospital organisation.~      The aim of this study is to analyse whom are the best among the health staff to predict the~     length of stay: ED nurses, admitting doctors og the specialist, and to analyse if a number~     of variables can be used to improve the prediction.~   "
101889|NCT01723436|"~     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The~     result is decision fatigue, in which subsequent decisions are altered toward the status quo.~     Surrogates are at risk for decision fatigue yet it has not been studied. We propose a~     randomized study in the outpatient setting in surrogates and patients at high risk for~     needing to make complex decisions, in an effort to determine the impact of decision fatigue~     on surrogate self-control and subsequent choices.~   "
101890|NCT01723423|"~     The MROC Study seeks to evaluate and compare from the patient's point of view the leading~     options for breast reconstruction after mastectomy. This study will help patients,~     physicians, payers and policy makers better understand the various surgeries available for~     breast reconstruction. Although many women choose reconstruction, the number of options as~     well as their pros and cons can make decision making difficult and stressful. From this~     research, we hope to learn more about what works best for patients undergoing these~     operations.~   "
101891|NCT01723410|"~     UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with~     internet access, are not pregnant, planning to become pregnant, or currently breastfeeding~     (if female), to participate in a study investigating whether real-world experiences alter~     the brain and body. This study takes place over an eight week period and involves providing~     the names of 8 close friends or family members, completing a neuroimaging session, providing~     blood and saliva (for genetic analysis), and a 6-week period in which participants login~     twice a week to complete online questionnaires. Compensation is up to $210 for those who~     complete all aspects of the study. Please email realworld.ucla@gmail.com for more~     information.~   "
101892|NCT01723397|"~     The objectives of this protocol are:~        1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal~          challenge with antigen, and~        2. to show that inhibition of the immediate response to nasal challenge with antigen by~          Nasaleze inhibits subsequent inflammatory events.~   "
101893|NCT01723384|"~     Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using~     and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in~     reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone~     is inexpensive and has few toxicities but the standard daily regimen for naltrexone is~     problematic as patients forget to take the medication. Given the challenges in daily dosing,~     alternate regimen schedules have been proposed to increase efficacy and expand the~     population that may benefit from this pharmacologic agent. One approach is intermittent~     targeted administration of naltrexone, whereby individuals take the medication as-needed in~     anticipation of substance use or during periods of craving. Administration of naltrexone~     prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone~     has shown efficacy in reducing heavy alcohol use. However, there have been no studies~     assessing intermittent targeted dosing of naltrexone among methamphetamine-using and~     binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those~     who abuse more than one substance are urgently needed. The aims of this study are to~     determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among~     non-dependent methamphetamine-using and binge-drinking MSM.~   "
101894|NCT01723371|"~     This study will determine the safety and feasibility of using a β-blocker (in this case~     carvedilol) in the treatment of pediatric patients with Left Heart Failure (LHF) in children~     with Pulmonary Arterial Hypertension (PAH). Carvedilol affects the nervous system, the same~     system that is highly activated in response to stress in patients with PAH. Each patient is~     administered a dosage of carvedilol, according to their weight. This dosage is increased~     incrementally over the span of the study, if the patient responds well to the drug. The~     study will determine whether the potential adverse side effects of carvedilol outweigh the~     possible positive results in reducing LHF. The hypothesis of this study predicts that~     carvedilol will have positive effects in treating LHF, similar to their use in treatment of~     Right Heart Failure (RHF). This is a single-centered pilot study. Each patient will be~     studied for approximately 31 weeks.~   "
101895|NCT01723358|"~     The goal of this study is to obtain data that well help inform the feasibility and design of~     a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES)~     technique in improving the swallowing function of young infants presenting with severe~     dysphagia.~   "
101905|NCT01723228|"~     This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,~     parallel-group study to evaluate the effect of rasagiline on cognitive function in adults~     with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).~   "
101918|NCT01723059|"~     Traditionally, H pylori infection has been treated with conventional triple therapy. This~     includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14~     days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy~     which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of~     clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We~     hypothesize that H. pylori resistance pattern and treatment response rates observed in~     Europe will not be predictive of resistance patterns and response rates in the United~     States.~   "
101896|NCT01723345|"~     Percutaneous coronary intervention (PCI) has become the most common form of coronary~     revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks~     including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It~     is estimated that approximately 25% of patients undergoing PCI have significant~     postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations~     and approximately 50% of patients have significant post-procedural troponin elevations.~     Initially, it was felt these elevations were simple enzyme leaks with no long-term~     implications.~      Now, several studies have demonstrated that periprocedural infarction is associated with~     short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment~     with antiplatelets such as aspirin and clopidogrel play an important role in reducing~     cardiovascular events (CV events) following PCI.~      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve~     response to aspirin and clopidogrel in low-response patients.~      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement~     [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term~     (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in~     patients undergoing elective PCI. Eighty patients planed to do elective PCI will be~     categorized into two groups. The first group will be received standard regimen for PCI~     (aspirin, clopidogrel, and heparin) and the second group will be treated with standard~     regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial~     was short-term (within 30-days) and long-term (after one year) incidence of MACE (death,~     myocardial infarction, or unplanned revascularization).~   "
101897|NCT01723332|"~     Transition is the planned movement of teens with chronic conditions from child-centered to~     adult-oriented healthcare. National bodies have published detailed guidelines about the~     importance of helping teens move to adult healthcare. However, there is no research~     regarding how to best organize and deliver Congenital Heart Disease (CHD) transition~     programs. Data is urgently needed. Therefore, the aim of this program is to develop research~     evidence that will better prepare health care providers to improve how they can help~     adolescents with transition.~      This project will determine whether a nurse-led transition intervention program is better at~     preparing teens with CHD to independently manage their medical care, compared to the care~     that is currently provided. The most important finding of this study will be whether or not~     these teens subsequently attend the adult cardiology clinic that specializes in CHD~     problems, and the timing of when they attend.~      Hypothesis: A transition intervention in combination with usual care, improved time to first~     Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.~   "
101898|NCT01723319|"~     Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil~     deep brain TMS in subjects with ADHD.~      Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients~     will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.~      Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding:~     The treatment administrator and the study personnel and patients will be masked to the~     treatment being administrated.~      The study group will receive active dTMS treatment and the control group will receive an~     inactive, sham treatment~   "
101899|NCT01723306|"~     T cells can penetrate virtually every biologic space and have the power to dispose of normal~     or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous~     remis-sions of cancer. However, T cells are easily tolerized to self or tumor antigens and~     immune surveillance has manifestly failed in every cancer that is clinically apparent. It~     is the goal of these studies to supply the specificities and affinities to patient T cells~     without regard for their endogenous T cell receptor repertoire, directed by~     antibody-defined recognition to kill malignant cells based on their expression of antigen.~     We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors~     to yield designer T cells from normal patient cells. This extends the approach of~     Anderson, Rosenberg and co-workers to introduce or augment expression of genes in patients'~     T cells in a therapeutic setting.~      Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified~     T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and~     cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore~     becomes of paramount interest to extend these studies to a human system of widespread~     clinical relevance to explore the clinical potential of this new technology. The target~     antigen for these studies is carcinoembryonic antigen (CEA) which is predominantly expressed~     on tumors of the colon and rectum, breast, pancreas and other sites.~   "
101900|NCT01723293|"~     The purpose of this study was to examine the behavior of the fetal heart rate in response to~     different intensities of acute maternal exercise in training and non-training pregnant women~   "
101901|NCT01723280|"~     Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and~     after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer~     diagnosis at a long-term follow-up.~      Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention~     of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI~     trial, found no difference in frequency of surgical site infection. In fact, long-term~     mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80%~     oxygen, and this appeared to be statistically significant in patients undergoing cancer~     surgery, but not in non-cancer patients.~      At this point, no convincing mechanism explains the observed increased mortality after~     hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.~      Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase~     the frequency of patients with a subsequent, new or recurrent, cancer.~   "
101902|NCT01723267|"~     Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte~     maturation and subsequent egg collection is largely based on follicle size. An accurate~     assessment of follicle size and appropriate timing of HCG result in retrieval of more mature~     oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the~     capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,~     identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute~     dimensions. These measurements include the largest diameters in three orthogonal planes, the~     mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter~     (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of~     this automated technique of follicle measurement vs. standard 2D technology on the timing of~     oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D~     assessment will increase the rate of mature oocyte collection, and eventually will improve~     other treatment outcomes such as fertilization rate.~   "
101903|NCT01723254|"~     The purpose of this study is to assess the safety and tolerability of different doses of~     PF-06444753 and PF-06444752 in subjects with allergic rhinitis.~   "
101906|NCT01723215|"~     Military deployment to combat zones involves exposure to trauma at a higher than average~     rate and therefore presents a unique opportunity to study predisposing factors to~     posttraumatic stress reactions and test strategies designed to prevent and ameliorate~     posttraumatic symptoms. Decades of scientific research on the origins of resilience and~     vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing~     and protective factors. All these factors however, offer limited opportunity for systematic~     pre-deployment prevention efforts. Considering the magnitude of psychological adjustment~     difficulties encountered by combat personnel in deployment and the limited access to~     existing evidence-based therapies for PTSD, the development and testing of a novel~     evidence-based and theory-driven prevention protocol for these problems is of considerable~     significance. The current study translates cognitive-neuroscience knowledge and attention~     bias modification research into a novel computerized training tool that could be easily~     delivered to soldiers during different stages of the deployment cycle. If proved efficacious~     in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's~     resilience training program. Thus, we propose a longitudinal double-blind randomized~     controlled study of ABMT in soldiers. We will assess attention bias and symptoms before~     deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8~     Placebo training sessions, or no training. Following 6 months of deployment to combat zone~     symptoms will be assessed again.~   "
101907|NCT01723202|"~     This randomized phase II trial studies how well dabrafenib works with or without trametinib~     in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether dabrafenib is more effective when given with or without trametinib in treating~     thyroid cancer~   "
101908|NCT01723189|"~     40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of~     stroke show a respiratory pattern characterized by central apnoeas and/or periodic~     breathing.~      Clinical studies conducted in patients with hearth failure and central apnoeas have~     demonstrated the pathogenetic central role of hypersensitivity of central and peripheral~     chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity~     of sympathetic nervous system.~      The joint study of chemoreflexes and baroreflexes in patients with central apneas during the~     acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in~     literature, that should supply useful elements to clarify the pathogenesis and the clinical~     and prognostic significance of these disorders.~      Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in~     patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than~     patients with ischemic stroke not accompanied by respiratory problems and compared with~     healthy controls.~   "
101909|NCT01723176|"~     Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent~     to that of echocardiography technicians/cardiologists for the purpose of determining~     etiology (reason) of cardiopulmonary failure.~   "
101910|NCT01723163|"~     The primary goal of the current study is to evaluate the effectiveness of a combined~     tele-health and contingency management (CM) intervention that investigators are calling~     Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a~     two-group design in which 300 Veteran smokers will be randomized to either:~      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines~     guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for~     access to nicotine replacement (NRT), and intensive behavioral therapy through mobile~     contingency management.~      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide~     controls for therapist, medication, time and attention effects. The tele-health intervention~     provides the same guideline based cognitive-behavioral smoking cessation telephone~     counseling (TC), and tele-medicine clinic for access to NRT as in the ART intervention.~   "
101911|NCT01723150|"~     Background: Klebsiella pneumoniae liver abscess is the most common etiology of liver abscess~     in Singapore and much of Asia, and its incidence is increasing. Current management includes~     prolonged intravenous antibiotic therapy, but there is limited evidence to guide oral~     conversion. The implicated K1/K2 capsule strain of Klebsiella pneumoniae is almost~     universally susceptible to ciprofloxacin, an antibiotic with high oral bioavailability. Our~     primary aim is to compare the efficacy of early (<1 week) step-down to oral antibiotics, to~     continuing 4 weeks of intravenous antibiotics, in patients with Klebsiella liver abscess.~      Methods/Design: The study is designed as a multi-centre randomised open-label active~     comparator-controlled non-inferiority trial, with a non-inferiority margin of 12%. Eligible~     participants will be inpatients over the age of 21 with a CT or ultrasound scan suggestive~     of a liver abscess, and Klebsiella pneumoniae isolated from abscess fluid or blood.~     Randomisation into intervention or active control arms will be performed with a 1:1~     allocation ratio. Participants randomised to the active control arm will receive IV~     ceftriaxone 2 grams daily to complete a total of 4 weeks of IV antibiotics. Participants~     randomised to the intervention arm will be immediately converted to oral ciprofloxacin 750mg~     twice daily. At week 4, all participants will have abdominal imaging and be assessed for~     clinical response (CRP <20 mg/l, absence of fever, plus scan showing that the maximal~     diameter of the abscess has reduced). If criteria are met, antibiotics are stopped; if not,~     oral antibiotics are continued, with reassessment for clinical response fortnightly. If~     criteria for clinical response are met by week 12, the primary endpoint of clinical cure is~     met. A cost analysis will be performed to assess the cost saving of early conversion to oral~     antibiotics, and a quality-of-life analysis will be performed to assess if treatment with~     oral antibiotics is less burdensome than prolonged IV antibiotics.~      Discussion: Our results would help inform local and international practice guidelines~     regarding the optimal antibiotic management of Klebsiella liver abscess. A finding of~     non-inferiority may translate to the wider adoption of a more cost-effective strategy that~     reduces hospital length of stay and improves patient-centered outcomes and satisfaction.~   "
101912|NCT01723137|"~     Patient reported pain, stress, and anxiety measures have been found to be inter-related, but~     it is not known if they are all associated with receiving opiate medications. The objective~     of this study is to determine if patients' degree of reported pain, stress, or anxiety is~     associated with receiving opiate pain medications in the emergency department or at~     discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are~     eligible to participate in the study. Consenting patients complete Visual Analog Scales~     describing their perceived pain, stress, and anxiety from enrollment until discharge.~     Demographic data and administration of pain medication is also recorded. Visual Analog Scale~     scores among patients who received an opioid pain medicine in the emergency department and~     at discharge will be compared to those who did not.~   "
101913|NCT01723124|"~     The purpose of this research is to evaluate whether repeating a screening Molecular Breast~     Imaging (MBI) study two years after an initial screening MBI study further improves breast~     cancer detection in women with dense breast tissue.~   "
101914|NCT01723111|"~     -  Dialysis modality may influence the oxidative stress and proinflammatory cytokines in~          ESRD patients.~        -  Dialysis modality may affect hepcidin~        -  Dialysis modality may influence iron and ESA requirements.~   "
101920|NCT01723033|"~     Comparison of the neurophysiological response of OCD and PTSD patients (both considered~     anxiety syndromes) in error processing. The patients will perform three computerized tasks~     while a net of electrodes (for EEG measurement) will be placed on their head. This data will~     then be compared to a previously collected healthy control sample.~   "
101921|NCT01723020|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 232 in~     subjects with advanced solid tumors or multiple myeloma~   "
101922|NCT01723007|"~     The study was designed to answer the primary question: the consumption of one apple three~     times daily between meals reduces serum levels of cholesterol above 240 mg/dL in overweight~     women? The second and important hypothesis was designed for evaluate the reduction in body~     weight by intakes of fruits. Therefore, the increased consumption of apples could displace~     the consumption of other foods and promoting satiety and input significant reduction in body~     weight compared to other fruit (Pear) of similar nutritional composition or food (cookies)~     made from oats with fiber and total calories similar to those observed in these fruits. To~     demonstrate the effectiveness of these supplements we used a clinical trial with three arms~     (apple, pear and oatmeal cookies).~   "
101923|NCT01722994|"~     Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of~     punch biopsy sites. The reason these are often preferred is because patients do not have to~     pay for another visit to get the suture material removed. Also patients are not~     inconvenienced into returning to the office for suture removal1. However, the absorbable~     suture material currently used by most Dermatologists is very expensive.~      In order to evaluate ways to reduce costs for patients, we will compare a less expensive~     suture material (chromic gut) with one of the absorbable suture materials currently used in~     clinical practice (PDS).~      Patients who are eligible and choose to participate in the study will undergo a punch biopsy~     and a suture will be used to close the skin. The type of suture received by the patient will~     be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive~     chromic gut suture.~      After one weeks time, the patient will return to clinic and their dermatologist will~     evaluate the biopsy site for redness, wound infection, wound opening, and scar formation.~     The patients will be given a questionnaire evaluating their satisfaction with the cosmetic~     outcome and any pain caused by the suture materials. If the suture came out before the~     visit, the patient will be asked to report on what day the suture fell out. The patients~     will return two more times over the next two weeks to receive the same questionnaire and~     evaluation by their dermatologist.~   "
101924|NCT01722981|"~     Percutaneous tracheostomy is routinely performed in most intensive care units in the~     world.Several studies have shown that the procedure is safe and economically efficient in~     comparison to open surgical operation in the operating room.~      In our institution as in a number of institutions in the country, it is acceptable to~     perform the operation by placing the tube on a high position near the vocal cords by direct~     laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by~     palpation of the neck.~      Using technological aids, such as direct sonography and bronchoscopy in real time may~     significantly reduce the rate of complications as a result of performing percutaneous~     tracheostomy.~      So far, no systematic comparison has been made among the three methods.~   "
101925|NCT01722968|"~     To explore molecular biomarkers and/or gene expression signatures that predict response to~     bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative~     metastatic breast cancer (MBC).~   "
101926|NCT01722955|"~     The aim of the study is to compare effect of pre-warmed intravenous fluids on the early~     outcomes in ambulatory patients undergoing monitored anesthesia care.~   "
101927|NCT01722942|"~     The primary objective is to compare the efficacy of the treatment using implantable~     cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in~     the primary prevention of all-cause mortality in high-risk patients with Chagas~     cardiomyopathy and non-sustained ventricular tachycardia (NSVT).~   "
101928|NCT01722929|"~     The aim of this study is to assess the role of skin sensors in obtaining reliable and~     accurate serial measurements of skin parameters in the context of cutaneous skin wound~     healing.~   "
101929|NCT01722916|"~     The purpose of this study is to find how much hyaluronidase should be used when receiving~     injections of fillers.~   "
101930|NCT01722903|"~     Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.~     About 90% of CRC related deaths are due to metastatic spread—mostly to the liver and lungs.~     With adequate multidisciplinary patient selection, CRC liver and lung metastasectomy~     significantly improves survival and offers the best chance for a cure. However, patients~     with limited lung or liver metastases are clinically underserved and poorly scientifically~     studied. The individual indication for resection and the decision making for adjuvant~     systemic therapies remains a challenge. More sensitive techniques to detect occult disease~     are needed for metastatic CRC (mCRC) patients, and perioperative analysis of circulating~     tumor cells (CTCs) may provide an outstanding opportunity to develop such innovative~     methods. We hypothesize that CTCs are enriched during CRC liver and/or lung metastasectomy,~     and that they can be isolated and characterized in an attempt to identify novel therapeutic~     targets.~      CTCs are believed to be causing metastasis and may provide a non-invasive alternative to~     organ biopsies for the detection, characterization and monitoring of solid cancers. CTC~     numbers have been shown to be a strong predictor of Progression Free Survival and Overall~     Survival for mCRC patients. The CellSearch system (Veridex LLC, Ratinas, NJ, USA) currently~     is the only FDA approved test for the evaluation of CTC numbers in metastatic breast,~     prostate and colorectal cancer. However, the rarity of CTCs in the blood leads to limited~     capture efficiency and the CellSearch system fixes cells, preventing further molecular~     characterization of CTCs by functional assays and primary cell culture. In this protocol the~     CellSearch system will be compared to a new technology, called the Flexible Micro Spring~     Array (FMSA) device, developed by Dr. Zheng, Department of Bioengineering, Penn State~     University, University Park. This novel approach enables size-exclusion based filtration for~     viable CTC enrichment. The FMSA device is inexpensive, works rapidly, and retains viable~     CTCs for further biological study. Using both the CellSearch system and the FMSA device, we~     will determine the kinetics of CTC shedding into circulation, develop an effective system~     for isolation, enumeration, and further enrichment CTCs, and use this system to find~     characteristics of different CTC populations.~   "
101931|NCT01722890|"~     Primary Objective:~      The primary aim of the study is:~      1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict~     Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with~     HER2-positive locally advanced or metastatic breast cancer.~      Secondary Objective:~      The secondary aims of the study are:~        1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics~          of DCR patients to identify any possible correlation between the tumour's biological~          and cytogenetic characteristics and the degree of clinical response to trastuzumab;~        2. To produce data in preparation for further translational studies on HER2-positive~          breast cancer.~   "
101932|NCT01722877|"~     Several studies have shown that stenting of the femoropopliteal artery in the lower leg~     leads to improved overall results compared to balloon angioplasty alone. However, scar~     tissue development can occur within the stent, a process called restenosis. Treatment of~     these in-stent restenotic lesions has a high procedural success rate but recurrence of scar~     tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis~     in the lower leg arteries but mixed results have been noted. In this study we hypothesize~     that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad)~     can lead to a high rate of acute procedural success with low intraprocedural complications~     and an acceptable recurrence rate of restenosis at 6-month follow-up.~   "
101933|NCT01722864|"~     A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or~     moderate to severe chronic low back pain.~   "
101934|NCT01722851|"~     To identify a panel of circulating miRNA markers which could help identify those breast~     cancer patients who are most likely to respond well to neoadjuvant and adjuvant~     chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into~     risk categories which would further guide their management. Similarly, the investigators aim~     to identify a panel of circulating miRNA markers which could monitor patient's response to~     chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show~     significant changes in expression level in good-responders whilst little or no change would~     be observed in miRNA expression in non-responders.~   "
101935|NCT01722838|"~     B-ME is a research intervention study designed to address the needs of African American men~     who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention~     is to decrease HIV risk behaviors among African American MSM using an intervention developed~     by and for African American MSM.~      The hypothesis guiding this study is: that participants who complete B-ME intervention will~     report greater reductions in sexual risk behaviors than the standard of care comparison~     group.~   "
101936|NCT01722825|"~     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in~     Japanese participants with advanced cancer or cancer that has spread to other parts of the~     body.~   "
101937|NCT01722812|"~     The purpose of this exploratory study is to investigate the clinical efficacy of~     cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis~   "
101938|NCT01722799|"~     Significant lesions in small coronary arteries are frequently found (35%-50%) in patients~     with coronary artery disease. Independently of the type of coronary angioplasty the~     restenosis and the need for repeat revascularization remains the main limitation,~     representing a challenging problem even in the DES (drug eluting stent) era. Recently has~     been developed drug eluting balloons (DEBs), which have been successfully tested in small~     series on in-stent restenosis, but few evidence is available in the context of small vessels~     disease.~      The current study has been designed to know, in one hand, the clinical efficacy of the Drug~     elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the~     cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE~     INTEGRITY) in patients with de novo lesions in small vessels.~   "
101939|NCT01722786|"~     Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as~     Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need~     urgent interventions/operations that cannot wait are included in this registry, or during~     emergency operations.~   "
101940|NCT01722773|"~     The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic~     obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has~     yielded variable effects on survival, quality of life and dyspnea. The investigators~     hypothesized that use of NPPV in stable COPD might result in improvement in quality of life~     and dyspnea.~   "
101941|NCT01722760|"~     Children born prematurely are of greater risk of developing chronic lung disease~     (Bronchopulmonary Dysplasia).~      With an increase in the amount of premature children, we expect an increasing number of~     children with BPD.~      Today we do not have many ways of predicting or treating this condition, and the children~     are usually in hospital for several months after birth. Many are dismissed with home oxygen.~     Children with BPD are typically often re-submitted to hospital with respiratory disease the~     first couple of years, and some of them have problems throughout childhood and into~     adulthood.~      Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary~     Disease (COPD).~      The condition as well as the treatment (steroids), are associated with great risk of adverse~     effects as Cerebral Palsy, blindness, deafness and mental retardation.~      The investigators wish to find a safe way to identify the children in greater risk of~     developing BPD, who could therefore benefit from a more intensive treatment.An early~     diagnosis would increase the possibility of predicting the prognosis.~      Other studies have proven a connection between both low vitamin A and D and high exhaled~     nitrogen oxide (NO) with lung disease.~      With this trial the investigators wish to make a reference material for NO and vitamins A~     and D in infants admitted to the neonatal department at two hospitals in Denmark, both with~     and without treatment with nasal Continuous Positive Airway Pressure.~      The investigators furthermore wish to describe an eventual connection between BPD and these~     factors by examining a large group of children on 7 specific occasions within the first two~     months of life and at a one year follow up.~   "
101942|NCT01722747|"~     BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a~     tobacco-control intervention geared towards school teachers in Bihar, India. This cluster~     randomized trial aims to promote tobacco use cessation among teachers and increase tobacco~     policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role~     models for youth and key opinion leaders related to community norms, they represent an~     important group for tobacco control. Teachers in Bihar also have reported high rates of~     tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of~     teachers in the eastern region of India (which includes Bihar) use some form of tobacco,~     compared to the national average of 29%. This study aims to reduce these numbers through~     discussion groups with teachers, individual cessation counseling, educational materials, and~     a tobacco policy workgroup in each intervention school. This study is a collaboration~     between US researchers and researchers at the Healis-Sekhsaria Institute for Public Health,~     Mumbai India.~   "
112978|NCT01577381|"~     The purpose of this study is to determine the efficacy, safety and tolerability of multiple~     doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular~     Degeneration.~   "
101944|NCT01722721|"~     physicians in the Emergency Department spend their time on interviewing and examining~     patients, file documentation, communication with colleagues about the patients.~      Introduction of IT technology aims to reduce the administrative workload. However it is the~     impression that more and more time are used behind the PC rather than at the side of the~     patient.~      The aim of this study is to describe how the time is distributed between different task for~     an ED physician, and to analyse whether there are differences in time distribution if the~     physician is working in the outpatient area versus admission area of the ED.~   "
101945|NCT01722708|"~     Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk~     pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.~     Clindamycin and metronidazole given orally are both acceptable treatments in these cases.~     The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole~     for the treatment of abnormal vaginal flora in high risk pregnancies. For this purpose,~     pregnant women who are considered high risk for preterm labor and were diagnosed with~     abnormal vaginal flora will be randomly treated either with clindamycin or metronidazole.~     Eradication of the abnormal flora and adverse effects will be monitored and compared~   "
101946|NCT01722695|"~     The purpose of the study is to show equivalent performance of the Revaclear dialyzer when~     compared to a dialyzer with larger membrane surface area.~      Study design: open, randomized, cross-over, multicentric, controlled prospective~      Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on~     patient needs~      Patients/sample size: 30 adult chronic hemodialysis patients~      Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions)~     with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.~      Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal~     of urea, phosphate, creatinine and ß2-microglobulin; albumin loss~      Primary variable: dialysis dose Kt/V urea~      Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and~     ß2-microglobulin~      Safety variable: albumin loss, blood count~   "
101947|NCT01722682|"~     The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for~     pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better~     site than liver (currently the location of choice for this procedure) thanks to its~     potential capacity to favor islet engraftment. To address our hypothesis we propose herein a~     randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D~     patients.~   "
101948|NCT01722669|"~     The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a~     single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase.~     Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with~     evidence of antiphospholipid antibodies~   "
101949|NCT01722656|"~     This study will evaluate the use of intravitreal aflibercept (anti-VEGF therapy) in patients~     with a type of macular degeneration known as vascularized pigment epithelial detachment.~     Previous studies have shown a generally poor outcome in treating this difficult to treat~     form of wet macular degeneration. More recently, multiple pilot studies have shown positive~     benefits to using anti-VEGF therapy. This study will evaluate the safety and efficacy of~     treating vascularize pigment epithelial detachment associated with wet macular degeneration~     with intravitreal aflibercept injection.~   "
101950|NCT01722643|"~     The overall goal of this project is to develop a novel family friendly intervention that~     will help teens with poor metabolic control of their type 1 diabetes increase and sustain~     daily self monitoring of blood glucose and lower HbA1c. This is important because poor~     metabolic control has long-term health implications. This project will provide important~     information regarding new effective ways to improve outcomes among teens with poorly~     controlled type 1 diabetes.~      Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and~     maintain glucose control, and (2) improve decision making (improve executive function and~     reduce delay discounting), which will predict treatment outcome.~   "
101951|NCT01722630|"~     Aim of this study was to investigate the cardiac and renal responses to the administration~     of different amount of crystalloids, with and without dopamine, during gynaecological~     laparoscopic surgery.~   "
101952|NCT01722617|"~     Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and~     joint swelling as well as thickening synovial (pannus) lesions that are responsible of~     osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity~     interspersed with remissions.~      The effectiveness of treatment is based on the proportion of patients who achieve a certain~     degree of improvement over the initial level of various parameters such as response criteria~     ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response~     criteria are now well validated but do not fully take into account the improvement of the~     patient's condition. In contrast, there is no questionnaire to identify the proportion of~     patients whose RA worsened between the medical visits. Such a questionnaire is necessary to~     detect flares outbreaks in daily practice and in randomized clinical trials, follow-up~     studies or longitudinal studies after drugs marketing to detect a reversal of disease~     activity.~      Both STPR group and OMERACT group have each developed such a new self-administered~     questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.~      The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA~     patients using the methodology advocated by the OMERACT in terms of validity (truth),~     discriminating power (discrimination) and feasibility~   "
101953|NCT01722604|"~     The main purpose of this prospective study is to demonstrate the therapeutic equivalence of~     topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic~     suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.~   "
101954|NCT01722591|"~     A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the~     Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended~     for percutaneous access and closure of the left ventricular apex in conjunction with~     transapical Transcatheter Aortic Valve Implantation (TAVI).~   "
102072|NCT01721044|"~     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is~     superior to placebo in the treatment of participants with moderately to severely active~     Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor~     (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic~     drugs (cDMARDs).~   "
101955|NCT01722578|"~     Hepatic encephalopathy (HE) is a potentially reversible functional disorder of the brain~     with neurological and psychiatric symptoms. HE occurs in up to 70% of patients with~     cirrhosis at some time during the course of disease. The chief neurotoxin implicated in the~     development of HE is ammonia. An important aim of treatment of HE is the reduction of the~     ammonia in the body by lowering the amount of ammonia produced and increasing its~     detoxification. Enteric production of ammonia can be decreased by non-absorbable~     disaccharides such as lactulose and antibiotics such as rifaximin. L-ornithine- L-aspartate~     (LOLA), the salt of the natural amino acids ornithine and aspartate acts through the~     mechanism of substrate activation to detoxify ammonia. In clinical trials, LOLA has shown a~     statistically significant effect with respect to reduction in HE grade, reduction of blood~     ammonia concentration and positive effects on psychomotor function in patients of cirrhosis~     with minimal HE and overt chronic Grade I HE, as compared to placebo. However, there is lack~     of data on the efficacy of LOLA in patients with overt acute hepatic encephalopathy which is~     one of the major causes of hospital admissions and resource utilization in decompensated~     cirrhotics. Each admission for HE causes a major financial loss to the family and financial~     burden on the society. Any drug which decreases the hospital stay by rapidly improving HE,~     will clearly lead to decreased hospital costs to the individual and the society as a whole.~     Hence, such a trial is a national priority. The investigators hypothesize that LOLA, if~     added to the standard treatment of overt acute HE (i.e lactulose), may lead to a faster~     recovery and decrease in hospital stay of these patients. In this prospective, randomized,~     placebo controlled trial, the investigators aim to evaluate the efficacy of intravenous~     L-ornithine, L-aspartate in reversal of overt acute hepatic encephalopathy in patients with~     liver cirrhosis.~   "
101956|NCT01722565|"~     Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the~     many prevention and treatment techniques that have been described. Since the introduction of~     laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia~     remains a surgical problem of considerable importance, requiring significant consumption of~     public health and economic resources, and representing a major alteration of the quality of~     life of these patients.~      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in~     elective surgery for laparoscopic abdominoperineal resection.~      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.~     Control group: Rectal neoplasms undergoing elective surgery for laparoscopic~     abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for~     laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and~     poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of~     65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28~     patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number~     will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal~     CT will be performed at 12 months along with another clinical evaluation.~   "
101957|NCT01722552|"~     The CATS project is designed to increase understanding of interventions that are feasible~     and effective in helping injection drug users (IDU) or other patients at high risk of poor~     medication adherence who are HIV-positive to maintain a high ART adherence. The study will~     involve: assessing the feasibility and acceptability of using real-time feedback, a wireless~     technology-updated adaptation of an approach the investigators found to be feasible and~     effective in China, to promote ART adherence among Chinese patients, including IDU;~     generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and~     HIV viral load; and identifying the factors that explain how real-time feedback influences~     intervention success or failure.~      The specific aims of the study are:~      SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless~     technology-updated adaptation of an approach we found to be feasible and effective in China,~     to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT~     of the real-time feedback intervention among Chinese patients in order to assess its~     feasibility and acceptability in this population.~      SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count,~     and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of~     effect sizes on these important endpoints.~      SA3: Describe the factors that explain how real-time feedback influences intervention~     success or failure. The investigators will use a quantitative-qualitative mixed-methods~     research approach to explore how the intervention influences the experience of adherence~     support in this patient population.~   "
101958|NCT01722539|"~     Considering the facts that: (i) IPT of malaria provides substantial protection against~     anaemia and malaria in school children (ii); SP resistance has no significant impact on the~     prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators~     hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,~     reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and~     school performance in school-aged children of Congo.~   "
101959|NCT01722526|"~     To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM~     in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose~     administration.~   "
101960|NCT01722513|"~     The aim of this prospective, randomized, controlled study is to investigate the effect of~     pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population~     of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary~     angiography, and evaluate the influence of such potential benefit on short-term outcome.~   "
101961|NCT01722500|"~     The primary aim of the International Study of Childhood Obesity, Lifestyle and the~     Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and~     obesity in a large multi-national study of 10 year-old children, and to investigate the~     influence of behavioral settings and physical, social and policy environments on the~     observed relationships within each country.~   "
101962|NCT01722487|"~     A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase~     Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive~     Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.~   "
101992|NCT01722097|"~     The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.~     Patients are allocated to either deep neuromuscular blockade and low intra-abdominal~     pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12~     mmHg).~      Primary hypothesis:~      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative~     pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).~   "
102116|NCT01720472|"~     The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional~     Review Board Pro00011196) to specifically target and enroll 1,000 participants across age~     groups and other demographic categories in order to develop a diverse cohort with specific~     physical and cognitive performance data paired with biological samples.~   "
101963|NCT01722474|"~     The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational~     device under development for the non-invasive assessment of arterial stiffness. The ASI~     Device is considerably smaller and more cost effective than its commercially available~     counterparts. As the device is readily portable, it is intended to be targeted for use in~     the community (or at home), as opposed to within the hospital or clinic setting only.~     However, as the device is still under development, it is not known whether it is capable of~     determining arterial stiffness with the same sensitivity and consistency as those already in~     commercial use. An added variable is the fact the sensor for the ASI Device is located on~     the fingertip.~      Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic~     purposes. The ASI Device has not been tested against other instruments capable of providing~     similar measurements. Therefore, a clinical trial to compare the ASI Device against similar~     devices is necessary. The study will compare measurements of arterial stiffness and other~     central haemodynamic parameters obtained with the ASI Device against similar measurements~     from devices that have already been approved for this purpose by Health Canada/United States~     Food and Drug Administration (FDA).~   "
101964|NCT01722461|"~     This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled~     will be randomly assigned to receive either active treatments for axillary hyperhidrosis~     with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System~     but with the energy settings on the device set to deliver no ultrasound energy. Subjects~     will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every~     one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days~     apart.~      Subjects and study personnel conducting efficacy measures will be blinded to the assigned~     treatment groups. The study hypothesis is that subjects in the active treatment group will~     have a greater reduction in underarm sweating compared to those in the sham group as~     measured by a quality of life questionnaire.~      All subjects will undergo follow-up assessments at 14 days and 30 days from the date of~     their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of~     their second study treatment. Subjects in the active treatment group will also undergo~     follow-up assessments at 9 months and 12 months from the date of their second study~     treatment.~   "
101965|NCT01722448|"~     The investigators want to find out whether a choline supplement can protect muscle health in~     young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense~     set of arm exercise and have a common genetic profile, will be asked to use a choline~     supplement for three weeks and a placebo for three weeks. Before the begin of the~     supplementation study and after 3 and 6 weeks the investigators will test response to the~     exercise challenge and ask that all consumed foods are recorded.~   "
101966|NCT01722435|"~     Only limited information on the process of completing long-term opiate substitution~     treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from~     scientific studies is scarce, there are only few studies with respect to treatment~     completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al.~     (2004) or Nordt & Stohler (2006) show an estimated rate of 10% of patients per year who~     terminate OST by means of tapering the substitution agent or changing into withdrawal~     treatment in specialized clinics. It is state of the art that an indication for termination~     of OST has to be based on a common agreement between the patient and the doctor.~     Furthermore, the patient should live in a stable social situation and the state of health~     had markedly improved. Finally, the patient has to be free of (illegal) drug use for at~     least 6 months and the individual aims of treatment should have been reached (Vader et al.~     2003).~      The main objective of the prospective and explorative study is the systematic description of~     the process of termination of OST. With a comparison between patients who complete OST~     regularly and patients who terminate treatment prematurely (or are still in treatment)~     predictors of positive termination of OST can be identified.~      Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2~     specialized clinics who might be able to terminate OST during the next 12 months from the~     doctors' perspective can take part in the study. In addition to baseline examination further~     assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires~     include state of health, well-being, social situation as well as drug and alcohol use.~     Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on~     infections and other disorders, clinical characteristics, dosage process and drug use~     (measured by urine samples).~      Patients who will be successful in completing OST during the observational period will be~     compared with the remaining cases.~      Finally, a 6-month follow-up is planned in order to investigate the stability and~     maintenance of the situation at month 12.~   "
101967|NCT01722422|"~     Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with~     septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion~     and oxygenation and may reduce the organ failure occurences. To date, only scarce data are~     available. Side effects are not well described. Therefore we designed a randomized clinical~     trial in order to assess the early administration of hypertonic saline and oxygen in the~     very early beginning of septic shock.~   "
101968|NCT01722409|"~     The investigators designed a double-blind, randomized placebo-controlled study to determine~     the effects of dexmedetomidine on the recovery characteristics of patients who were~     scheduled to undergo endovascular coil embolization.~   "
101969|NCT01722396|"~     Previous studies of vitamin D supplementation have suggested there may be differences in~     response between individuals. This study is an open label study of vitamin D supplementation~     in patients with active or latent tuberculosis in which active disease patients take~     100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for~     relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex~     vivo markers of vitamin D response. Latent patients will only be studied for vitamin D~     response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells~     will be related to polymorphisms in the DBP gene, and that this may relate to clinical~     response in terms of post supplementation vitamin D level.~   "
101970|NCT01722383|"~     Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated~     with significant morbidity and mortality. People at highest risk from progressive CKD are~     defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the~     presence of significant albuminuria/proteinuria. Accurate mapping of the bio-clinical~     determinants of this group will enable improved risk stratification and direct the~     development of better targeted management for people with CKD. To address these requirements~     we have established the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling~     a cohort of patients at high risk from progressive CKD and compiling a comprehensive and~     detailed bio-clinical phenotype, including vascular and oral health phenotyping, at~     enrolment and on subsequent follow-up.~   "
102117|NCT01720459|"~     The purpose of this study is to determine whether micronized trans-resveratrol improves~     clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,~     markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).~   "
101971|NCT01722370|"~     Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels,~     because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15~     hours per day, and has established indications and benefits in COPD. However, the~     indications for and benefits from ambulatory oxygen supplementation (oxygen just when~     walking or exercising) are less well understood, in part due to heterogeneity of previous~     study designs, and lack of long term follow up. This is a pilot study of supplementary~     ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring~     their degree of systemic inflammation pre and post oxygen supplementation, and measuring~     changes in gene expression in muscles by means of microarray profiling. Secondly, our study~     will utilise follow up of clinical parameters including home activity monitoring to~     ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our~     hypothesis is that exertional hypoxia results in muscle dysfunction and this could be~     prevented by oxygenation.~   "
101972|NCT01722357|"~     The purpose of the study is to address 3 main sets of questions in the bariatric surgery~     population. 1) Does bariatric surgery, without any other intervention, lead to increased~     physical activity and improved physical fitness? 2) Does wearing a pedometer lead to~     increased physical activity in obese individuals prior to and/or after bariatric surgery?~     Does the increased activity result in improvements in physical fitness? 3) Does physical~     activity counseling increase physical activity prior to and or/after bariatric surgery? Does~     the increased activity result in improvements in physical fitness? The overall goal of the~     study is to determine the impact of bariatric surgery on physical activity and assess the~     utility of additional interventions to help postoperative patients adopt a more active~     lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus~     exercise counseling before and for the first 6 months after bariatric surgery. In an~     extension of the primary study, from 1 to 5 years after surgery, all patients receive~     exercise counseling. Physiological measures will be assessed to determine whether bariatric~     surgery and/or improved physical activity levels result in improved physical fitness.~   "
101973|NCT01722344|"~     The purpose of this study is to investigate the efficacy of IPS in Denmark and compare~     effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and~     work-related social skills training vs. 3. standard intervention, among individuals with~     severe mental illness.~   "
101974|NCT01722331|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of~     subcutaneous MK-3222, followed by an optional long-term safety extension study, in~     participants with moderate-to-severe chronic plaque psoriasis.~   "
101975|NCT01722318|"~     This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in~     patients with IBS-C.~   "
101976|NCT01722305|"~     This phase I trial studies the side effects and best dose of pomalidomide when given~     together with dexamethasone in treating patients with primary central nervous system~     lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or~     intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may~     stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, stopping them from dividing, or by stopping them from spreading. Giving~     pomalidomide together with dexamethasone may kill more cancer cells.~   "
101977|NCT01722292|"~     The purpose of this study is to find a recommended dose of LY2940680 that can be safely~     given in combination with etoposide and carboplatin followed by LY2940680 alone in~     participants with extensive-disease small cell lung cancer. The study will also compare~     progression-free survival in participants who are administered etoposide, carboplatin and~     LY2940680 followed by LY2940680 alone versus etoposide, carboplatin, and placebo followed by~     placebo alone.~   "
101978|NCT01722279|"~     The primary purpose of this study is to examine the breadth, nature, and factors affecting~     the long term changes in physical and psychological health and quality of life (QOL)~     following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey),~     postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes.~     Archival data available from patient medical records will also be gathered.~   "
101979|NCT01722266|"~     Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting,~     postprandial and the overall mean glucose concentrations.~      Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of~     weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to~     and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide~     daily. In addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and~     <40 mg/dl will also be compared.~      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and~     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose~     concentrations will be measured as areas under the curve for the data obtained from the meal~     challenge.~      Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment~     with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in~     patients with type 1 diabetes decreases postprandial glucagon concentrations and increases~     postprandial C-peptide concentrations.~      Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following~     a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide~     daily.~      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric~     emptying.~      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and~     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.~   "
101980|NCT01722253|"~     The purpose of this study is to determine whether electroacupuncture is a effective tool to~     the postoperative analgesia~   "
102000|NCT01721993|"~     THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the~     safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in~     healthy postmenopausal women. The study is expected to identify a safe dose that can be~     further tested in subsequent multiple dose studies comparing the safety, PK and~     pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).~   "
102194|NCT01719445|"~     The Primary Aim of the project is to modify the RFPM for adolescents and to address the~     concerns identified by the reviewers of the first grant application. We will then test the~     RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.~   "
101981|NCT01722240|"~     The control of glucose homeostasis in subjects with type 1 diabetes is fragile since~     exogenous insulin cannot compensate for changing requirements and is not precise either in~     terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near~     total absence of insulin secretion, the physiological post prandial inhibition of glucagon~     secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a~     need for therapies beyond insulin that can further improve glycemic control and reduce~     fluctuations in glucose in these subjects. The investigators have recently shown that~     Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours,~     when added to insulin in subjects with well controlled type 1 diabetes reduces mean and~     standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide~     concentrations did not alter following Liraglutide, it is likely that the suppression of~     glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists~     are well established in subjects with type 2 diabetes, however, these have not been studied~     prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed~     this study to investigate the central hypothesis that in patients with type 1 diabetes,~     Liraglutide has a glucose lowering effect. A major secondary objective of this study is to~     elucidate the mechanisms responsible for its glucose lowering effects and those involved in~     reducing the insulin dose. The specific aims of this proposal are:~      Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c,~     fasting, postprandial and the overall mean glucose concentrations while decreasing the dose~     of insulin required.~      Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard~     deviation of weekly blood glucose concentrations as recorded by continuous glucose~     monitoring and the dose of insulin required prior to and following 52 weeks of treatment~     with 1.2 mg of liraglutide daily.~      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and~     after 52 weeks of treatment with 1.2 mg of liraglutide daily.~      Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal~     and postprandial glucagon concentrations and increases basal and postprandial C-peptide~     concentrations.~      Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations~     following a test meal before and after 52 weeks of treatment with 1.2 mg of liraglutide~     daily.~      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric~     emptying.~      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and~     after treatment with 1.2 mg of daily subcutaneous liraglutide.~   "
101982|NCT01722227|"~     This is the first prospective randomized double-blind placebo-controlled study to~     investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels~     and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the~     preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of~     the drug are consistent with a sustained duration of action. The current gold standard for~     management of type 1 diabetes is based on insulin replacement with novel analogs with~     specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump~     therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.~     This study will also investigate the effect of liraglutide on suppression of glucagon~     secretion during meal challenges. This is of particular importance since, in the absence of~     insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by~     the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall~     pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will~     allow us to determine the rapidity, consistency, and sustainability of any response to~     liraglutide.~   "
101983|NCT01722214|"~     This study is a double-blinded randomized multicenter placebo controlled trial to determine~     the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in~     patients with moderate to severe psoriasis.~   "
101984|NCT01722201|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult human subjects.~   "
101985|NCT01722188|"~     This is a prospective, multi-center, actively monitored, long term data collection registry.~     Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a~     compatible market released cardia rhythm management (CRM) implantable pulse generator is~     eligible for enrollment into the registry.~   "
101986|NCT01722175|"~     This randomized phase II trial compares how well associating liver partition with portal~     vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in~     treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for~     removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would~     traditionally be considered inoperable.~   "
101987|NCT01722162|"~     This randomized phase II trial studies how giving a drug called levocetirizine to patients~     with colorectal cancer affects their tumor response to capecitabine and bevacizumab.~     Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA~     synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that~     blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels~     that feed them. Patients with colorectal cancer can develop a resistance to the effects of~     bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving~     bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective~     treatment for refractory colorectal cancer.~   "
101988|NCT01722149|"~     MPM patients are not eligible for surgical procedures like decortication or~     pleuro-pneumectomy and have a median survival of 12 months with palliative chemotherapy.~     Therefore, new therapeutic approaches are of crucial need in this clinical situation. This~     is a phase I trial for patients with malignant pleural mesothelioma with pleural effusion~     testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific~     re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21~     days before transfer from peripheral blood. CD8 positive T cells will be isolated and~     re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP~     which serves as target structure in MPM.~        -  Trial with immunomodulatory product / biological~   "
101989|NCT01722136|"~     The overall goal is to determine whether any energy expenditure compensation in response to~     16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose~     intervention in older women, and to begin to investigate underlying physiological mechanisms~     that influence energy expenditure changes in older women.~   "
101990|NCT01722123|"~     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The~     result is decision fatigue, in which subsequent decisions are altered toward the status quo.~     Patients are at risk for decision fatigue yet it has not been studied. The Investigator~     proposes a randomized study in the outpatient setting in patients at high risk for needing~     to make complex decisions, in an effort to determine the impact of decision fatigue on~     participant self-control and subsequent choices.~   "
101991|NCT01722110|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, male and female human subjects.~   "
102011|NCT01721850|"~     The study is conducted to examine the safety and efficacy of a new infant formula and its~     effects on the gastrointestinal tolerance in infants suffering from colic.~      Primary hypothesis to be tested is: an infant formula with optimized composition improves~     colicky symptoms compared to a standard formula.~   "
101993|NCT01722084|"~     Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe~     abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on~     unidirectional interventions aiming at a single determinant of adolescents´ sexual and~     reproductive health. However, evidence exists that a complex health problem should be~     addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to~     develop a comprehensive approach to promote adolescents' sexual health.~      The CERCA study will conduct an implementation based on the hypothesis that a comprehensive~     strategy of community-embedded interventions helps to improve the sexual health of~     adolescents. We will test this hypothesis and describe the development, implementation and~     testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca~     (Ecuador) and Managua (Nicaragua).~      The research methodology has been designed based on the methodological frameworks of action~     research, community based participatory research and intervention mapping.~      The interventions are complex addressing different target groups (adolescents, parents,~     authorities and health providers) and focussing on various behaviours that are related to~     communication about sexuality, information seeking, access to health care and safe sexual~     intercourse.~      For the evaluation of effectiveness a randomised and non-randomised controlled study was~     developed for respectively Managua and the two other cities. Furthermore a process~     evaluation is conducted.~      This research will result in a framework that will contribute to the planning of~     interventions that are effective and responsive to adolescents' sexual health needs.~   "
101994|NCT01722071|"~     The proposed study will investigate the effects of intranasal oxytocin administration on~     neural activity associated with social and non-social motivation.~   "
101995|NCT01722058|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the colon. The current endoscopes used to look at the colon are very good,~     but if the area doesn't look different to the naked eye, then the endoscope can't improve on~     that. We are looking at using special fluorescent stains in addition to special endoscopes~     designed to see abnormal areas that are not obvious to the naked eye. Currently specialized~     microscopes and fluorescent stains are used in clinical laboratories but it takes several~     days of processing to get results. It may be very helpful to look for areas to sample for~     abnormal tissue during the endoscopy procedure.~      You are being asked to let us spray a fluorescent peptides into your right colon. Peptides~     are small chains of amino acids (the building blocks that make up proteins) linked together.~     Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the~     one used by your eye doctor).~      We have prepared this special fluorescent peptide to target and bind to any abnormal areas~     if present, and glow when a special light is used. In this study, we will apply the~     special fluorescent peptide by a spray catheter to your right colon to asses for safety. The~     colonoscope used in this study is the usual colonoscope used and is not able to see the~     fluorescence.~      This is a phase 1 study. This means that this is the first time we have used this kind of~     fluorescent peptide in people. The Food and Drug Administration (FDA) has not approved~     this agent, but is allowing us to test it in this study. The goal of this study is to see if~     there are any side effects from using the peptide. We have used a similar peptide that we've~     developed for the esophagus in over 40 patients without any side effects.~      This is the first test of this agent, so it won't be used to change how colonoscopy is done.~   "
101996|NCT01722045|"~     This is a phase 4, open-label, single arm, multicenter, clinical study in patients with~     neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept~     Injection (IAI) administered over 2 years , and to provide clinical information from the~     first year in the trial evaluating the adverse effects, if any, on the corneal endothelium~     following administration of IAI.~   "
101997|NCT01722032|"~     Background: Many unhealthy dietary and physical activity habits that foster the development~     of obesity are established by the age of five. Presently, approximately 70 percent of~     children in the United States are currently enrolled in early childcare facilities, making~     this an ideal setting to implement and evaluate childhood obesity prevention efforts. We~     describe here the methods for conducting an obesity prevention intervention randomized trial~     in the child care setting.~      Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income,~     ethnically diverse child care centers located throughout Miami-Dade County, FL is currently~     being conducted over two years (2010-present) to test the efficacy of an intervention that~     poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy~     Children (HC2) program includes a curriculum focusing specifically on healthy food choices,~     increased exercise, and role modeling. The program targets food policy changes throughout~     the school, and via the child, caregiver, and teacher. Major outcome measures include child~     body mass index percentile and z score, fruit and vegetable and other nutritious food~     intake, and amount of physical activity.~      Discussion: Although few attempts have been made to prevent obesity during the first years~     of life, this period may represent the best opportunity for obesity prevention. Findings~     from this investigation should inform both the fields of childhood obesity prevention and~     early childhood research about the effects of an obesity prevention program housed in the~     childcare setting. (H1) A child care center-based obesity prevention intervention program~     that includes a teacher and parent nutritional gatekeeper and role modeling program will be~     more effective in maintaining BMI in 3-5 year olds compared to a control group.~      (H2) Role modeling (teacher and parent) will be identified as a significant mediator in~     preventing obesity among intervention children versus controls.~      (H3) A child care center-based multi-level obesity prevention intervention program will~     improve child nutrition (increased consumption of fruits and vegetables, decreased~     consumption of sweetened beverages) and increase physical activity level compared to a~     control group.~   "
101998|NCT01722019|"~     Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open~     crossectomy and stripping. The two most performed techniques for endovenous ablation are the~     endovenous laser ablation and the radiofrequency ablation. According to the trial of~     Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in~     more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in~     observational studies. The aim of this study is to compare radiofrequency ablation with the~     VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new~     fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point~     necroses of the vessel wall and on consequence results in lesser side effects from wall~     perforations such as pain, haematoma,…~   "
101999|NCT01722006|"~     Classical conditioning is widely used to study motivational properties of addictive drugs in~     animals, but has rarely been used in humans. Here, we are establishing a procedure suitable~     for studying the neurobiology and individual determinants of classical conditioning in~     humans. Healthy volunteers are randomly assigned to four groups that received~     methamphetamine or placebo in the presence of distinctive environmental cues under paired or~     unpaired conditions. During each session, subjects perform tasks known to activate the~     ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive~     context, consisting of a screen background image of a beach or of mountains, accompanied by~     corresponding sounds. Separate groups of subjects carry out the tasks under high or low~     reward conditions. Within each of the two reward conditions, one group (paired), receives~     methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts,~     while the other (unpaired) receives drug or placebo unrelated to context. A fifth group~     (paired) perform the tasks with contextual cues but in the absence of monetary incentives.~     Before and after conditioning, participants carry out a series of forced choice tasks, and~     change of preference over time was analyzed.~   "
102012|NCT01721837|"~     Non-interventional, observational study of physicians' use of Dabigatran etexilate for~     stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment~   "
102001|NCT01721980|"~     The purpose of this study is to evaluate the safety and tolerability after multiple~     ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to~     placebo.~      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and~     urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related~     parameters in the blood and stool samples (pharmacodynamics) will be characterized compared~     to placebo.~      Also, the effect of the compound on glucose tolerance will be explored as well as the~     potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.~   "
102002|NCT01721967|"~     The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic~     Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical~     therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for~     the treatment of angina in a novel patient population (adult patient population with~     hypertrophic cardiomyopathy).~   "
102003|NCT01721954|"~     This study is a randomized, multi-center study that will compare the efficacy and safety of~     selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard~     chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients~     with non-resectable liver metastases from primary colorectal carcinoma.~      Treatment with the biologic agent bevacizumab, if part of the standard of care at~     participating institutions, is allowed within this study at the discretion of the~     Investigator.~   "
102004|NCT01721941|"~     The primary objective of this phase I dose escalation study is to determine the maximum~     tolerated dose of TH-302 when administered with doxorubicin via trans-arterial~     chemo-embolization (TACE) in patients with hepatocellular carcinoma (HCC) who are not~     transplant candidates and have unresectable disease. HCC is the second leading cause of~     worldwide cancer death and is generally incurable without liver transplant. TACE can convert~     about 40% of these patients to transplant candidates. Additionally, in non-transplant HCC~     patients, TACE confers statistical improvements in overall survival. Selective HCC arterial~     catheterization during TACE allows for the delivery of concentrated drugs to the liver tumor~     but the optimal TACE chemotherapy regimen has not yet been determined. TH-302 is a hypoxia~     inducible agent that can be activated in the hypoxic environment induced by TACE.~   "
102005|NCT01721928|"~     The main purpose of the NORIDES study is to investigate the effect of pharmacological~     thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients,~     and how it is affected by presence of acute kidney injury (AKI) and treatment with~     hemodialysis. The main objective is to compare the prophylactic effect of dalteparin in~     intensive care unit (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis)~     with a control group of ICU patients with normal kidney function. Our main hypothesis is~     that CiCa-dialysis reduces dalteparin effect, and that patients undergoing CiCa-dialysis do~     not achieve adequate prophylaxis against venous thromboembolism (VTE). The primary endpoint~     is development of DVT during ICU stay, the secondary endpoint inadequate heparin effect~     measured in blood samples.~   "
102006|NCT01721915|"~     Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria.~     PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility.~     New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD)~     supplementation significantly improved glucose metabolism and fertility. However, the~     efficacy of vitD administration shows individual variability indicating endogenous~     influences on pharmacological effects.~      A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC)~     associated with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already~     been known to be associated with insulin resistance.~      Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS~     and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD~     related genetic determinants adjusted for environmental factors.~      Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To~     generate the hypothesis that changes in metabolic and endocrine parameters following vitD~     treatment are associated with vitD related gene variants.~      Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, [25(OH)D]) levels <30~     ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled~     trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD~     related genetic variants. In addition, 150 non-PCOS women with 25(OH)D <30 ng/ml will be~     treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24~     weeks and investigated for metabolic and endocrine parameters as well as vitD related~     genetic variants. The response to vitD supplementation in both groups will be analysed~     according to genotype profiles.~      Significance: VitD might be a new therapeutic option without major side effects for PCOS~     patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window~     for therapy modulation in PCOS and other metabolic diseases.~   "
102007|NCT01721902|"~     The primary objective of this study is to demonstrate the feasibility and safety of~     intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells~     at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic~     cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow~     stem cells will be assessed.~      The investigators hypothesize that collection of a sufficient number of CD133+ cells through~     bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial~     injection of high purity cells following completion of CABG, will be feasible without~     significant adverse clinical consequences.~   "
102008|NCT01721889|"~     The primary objective of this pilot study is to determine the precision of post-operative~     radiostereometric measurements for the assessment of lumbar spinal fusion. This study will~     also determine the potential for RSA as a more precise and accurate means for assessment of~     lumbar spinal fusion and diagnosis of pseudarthrosis.~   "
102009|NCT01721876|"~     To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib +~     subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated~     acute myeloid leukaemia, ineligible for intensive remission induction therapy~   "
102010|NCT01721863|"~     Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological~     mechanisms of AF include abnormal electrical conduction in atrium and sympathovagal~     imbalance with increased vagal tone. Patients with AF have poor exercise capacity that may~     contribute to decreased atrial effective refractory period, and decreased cardiac output and~     heart rate reserve, and may result in poor quality of life. Poor endothelial function had~     been noted in patients with AF, associated with increased risks of cerebrovascular and~     cardiovascular disease. Exercise training has been noted to improve exercise capacity and~     quality of life in patients with AF only in some studies. Endothelial function can be~     improved by exercise training in patients with cardiovascular disease, but no report in~     patients with AF. Evidence of exercise training is still needed in patients with AF. The~     purpose of this study is to investigate the effect of exercise training on~        1. endothelial function~        2. heart rate variability~        3. exercise capacity~        4. quality of life.~   "
102013|NCT01721824|"~     The aim of the present study, is to evaluate the effect of a supported employment~     intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or~     education, when offered to people with onset mood or anxiety disorders who are not likely to~     be able to return to work within three month.~      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and~     more people returning to work or education, compared to treatment as usual.~   "
102014|NCT01721811|"~     The aim of the study is to investigate how the retina adapts to different metabolic~     challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or~     diets as well as transient changes in the content of oxygen and glucose in the blood.~   "
102015|NCT01721798|"~     This study will inform international medical guidelines as to whether the Levonorgestrel~     intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive~     method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for~     HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and~     acceptable, the introduction of this method to HIV positive women in developing countries~     could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and~     confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.~   "
102016|NCT01721785|"~     The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI~     and gadofosveset-enhanced MRI for the management of rectal cancer patients.~   "
102017|NCT01721772|"~     The purpose of this study is to compare the clinical benefit, as measured by overall~     survival, of nivolumab with that of. dacarbazine in patients with previously untreated,~     unresectable, or metastatic melanoma~   "
102018|NCT01721759|"~     The purpose of the study is to assess the objective response rate (change in tumor size from~     baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer~     treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens~   "
102019|NCT01721746|"~     The purpose of the study is to compare the response rate and overall survival of patients~     taking BMS-936558 to those taking study physician's choice of either Dacarbazine or~     Carboplatin and Paclitaxel~   "
102020|NCT01721733|"~     The purpose of this study is to evaluate the effects of EPI-743 in children with Leigh~     syndrome on disease severity, neuromuscular function, respiratory function, disease~     morbidity and mortality and disease associated biomarkers.~   "
102021|NCT01721720|"~     Background:~      - Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable~     of all neuropsychiatric disorders. It causes problems with attention and impulse control.~     However, the genetic component of ADHD has not been fully studied, including how genes~     interact with the environment. Researchers want to study children and adults who have ADHD.~     They will look at how genetic, brain structure, and environmental factors affect ADHD in~     children and adults.~      Objectives:~      - To study genetic, brain structure, and environmental factors in ADHD in children and~     adults.~      Eligibility:~      - Individuals at least 3 years of age who have ADHD.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be interviewed about their ADHD. They will also complete behavior and~          psychological tests. Parents or guardians will complete the tests along with~          participants under 18 years of age.~        -  Participants will provide saliva or blood samples.~        -  Participants will also have imaging studies of the brain.~        -  Participants under 25 years of age will return once a year to repeat the tests. Those~          over 25 years of age will have only the one set of tests. Those who are starting~          stimulant drugs and who are receiving behavioral treatment for the first time will also~          have another set of tests 12 weeks after the start of treatment.~   "
102022|NCT01721707|"~     This study is a double-masked, randomized, parallel group study in patients with open angle~     glaucoma or ocular hypertension.~      The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50~     mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in~     reducing IOP~   "
102023|NCT01721694|"~     To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5%~     Loteprednol eye drops for the treatment of ocular inflammation and infection associated~     bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the~     individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).~   "
102024|NCT01721681|"~     The primary objective of the study is to assess the efficacy of FACTOR X in the prevention~     of bleeding when given as routine prophylaxis over 12 months.~      The secondary objectives of the study are:~        1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg.~        2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26~          weeks).~   "
102025|NCT01721668|"~     Improving arm and hand function after stroke has been difficult to achieve within the~     rehabilitation service provided in the acute stage often due to the limited resource in~     health care. While spontaneous recovery plateaus after 6 months, the prolonged disability~     affects quality of life and social participation in stroke survivors. This study is aimed at~     improving chronic motor impairment arm and hand impairment by providing the intervention~     with intensive training schedule. This study will compare two types of rehabilitation~     intervention using a randomized controlled trial. Measurements also will be taken on various~     brain functions non-invasively to help discover how each of the intervention strategies~     works differently to repair the brain.~   "
102040|NCT01721473|"~     Cigarette smoking is more prevalent among Veterans (27%) than the general U.S. population~     (21%). Smoking is common among people who use marijuana or caffeine heavily, and the use of~     menthol cigarettes is becoming increasingly common, affecting approximately 9% of the~     Veteran population. Recent research by the group and others indicates that heavy marijuana~     or caffeine use, or the use of predominantly menthol cigarettes, can alter brain nicotinic~     acetylcholine receptor (nAChR) densities. For the proposed study, brain imaging with PET~     scanning will be used to determine nicotine receptor densities in Veteran cigarette smokers~     with and without heavy marijuana or caffeine use, and in menthol and non-menthol Veteran~     smokers. Results of the proposed research may have implications for improving treatments for~     Veterans who smoke cigarettes and who have specific drug use co-morbidities or who use~     menthol cigarettes.~   "
102986|NCT01709149|"~     The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357~     when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic~     Lateral Sclerosis (ALS).~   "
102026|NCT01721655|"~     Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major~     complication of premature birth and is associated with a significant increased risk of~     complications including death. Diuretics have been used for decades in babies with BPD and~     are considered a standard of care. Patients receive electrolyte supplementation to replace~     the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics~     at removing extra fluid, but it is different from chlorothiazide and furosemide because~     instead of removing potassium, it actually can increase potassium levels in our body.~     Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,~     reduce the electrolyte supplementation needed. However, studies have suggested that preterm~     babies aren´t developed enough to appropriately respond to spironolactone. Also, one study~     has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on~     whether or not patients receive electrolyte supplementation. This study will examine whether~     there is a difference in the amount of electrolyte supplementation between patients~     receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators~     hypothesize there will be no difference in the amount of electrolyte supplementation between~     the two groups.~   "
102027|NCT01721642|"~     A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and~     Closure Device for accessing and closing the left ventricular apex during and after~     Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made~     post-procedure, at 30 days and 90 days as well as longer term follow-up.~   "
102028|NCT01721629|"~     The aim of this study is to investigate two different strategies for the withdrawal of CPAP~     in preterm infants born before 32 weeks of gestation.~   "
102029|NCT01721616|"~     Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as~     the most frequent post-cesarean delivery complication. This increased morbidity translates~     into extended post-partum antibiotic use and prolongation of hospital stay with the~     subsequent increase in health care expenses. The current regimen recommended by the American~     College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation~     cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been~     associated with an increased risk of endometritis in post-cesarean section patients.~     Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely~     covers Ureaplasma and would be an excellent second antibiotic for cesarean section~     chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard~     chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section~     endometritis.~   "
102030|NCT01721603|"~     The purpose of this study is to test the safety and find out what effects, good and/or bad,~     dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife~     radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and~     brain metastases (tumors that have spread to the brain).~   "
102031|NCT01721590|"~     Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent~     reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this~     prospective randomized study,all patients in control group will receive blank placebo ,all~     patients in test group will receive tongxinluo.All patients will be followed up for one~     year.~   "
102032|NCT01721577|"~     This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the~     safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent~     formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas~     (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic~     oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A~     treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28~     days during cycle 5). The following cycle will not be started until the treatment~     continuation criteria are fulfilled. Concomitant supportive therapies will be allowed.~   "
102033|NCT01721564|"~     6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in~     pulmonary microvascular endothelial function.~   "
102034|NCT01721551|"~     The purpose of the current study is to investigate whether changes in patients' sleep~     quality and quantity will be followed by improvements in parameters related to physical and~     mental fatigue in patients receiving hemodialysis therapy.~      More specific, the current project will investigate the effect of a 9 months intradialytic~     exercise training in aspects related to fatigue, quality of life and depression.~   "
102035|NCT01721538|"~     SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary~     prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with~     two arms. The therapy arm is participating in a comprehensive weight reducing program,~     whereas the control group takes part in a lecture on healthy nutrition. The primary study~     objective is to assess the efficacy of non-drug therapeutic weight reduction in the~     secondary prevention of stroke. Secondary objectives are functional outcome, cognitive~     status, post stroke depression, and health-related quality of life.~   "
102036|NCT01721525|"~     This study seeks to develop a new induction chemotherapy regimen which is a combination of~     two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which~     means that the primary goal is to establish the recommended dose of an investigational drug~     when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of~     the investigational drug.~   "
102037|NCT01721512|"~     Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,~     Indonesia~   "
102038|NCT01721499|"~     This is a study of treatment approaches aimed to improve self-control and decrease stress~     and unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.~      High levels of stress may make it harder to maintain self-control, especially when trying to~     control our unhealthy behaviors. Training on improving self control and decreasing stress~     may help decrease unhealthy behaviors. The goal of this new training program will be to~     decrease a subject's unhealthy behavior by helping them better manage their stress and~     improve their self control over unhealthy habits.~   "
102039|NCT01721486|"~     The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain~     control in children undergoing tonsillectomy with or without adenoidectomy.~   "
102987|NCT01709136|"~     Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant~     recipients.~   "
102041|NCT01721460|"~     The purpose of this research study is to find out whether dexmedetomidine changes brain cell~     activity in the subthalamic nucleus (STN).~      In order to find whether dexmedetomidine is optimal for sedation during Deep brain~     stimulation surgery, we will measure the electrical activity in the STN during Deep brain~     stimulation surgery, and measure how this activity is changed during administration of~     Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and~     pattern in the STN.~   "
102042|NCT01721447|"~     The investigators intend to determine if using Optison echocardiography contrast increases~     sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal~     echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of~     echo contrast.~   "
102043|NCT01721434|"~     Levosimendan is a relatively new drug that improves cardiac contractility in patients with~     heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial~     contractile proteins. Recent data from our lab showed that levosimendan improves~     contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in~     vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of~     disorders associated with impaired respiratory muscle function, such as mechanically~     ventilated patients.We hypothesize that levosimendan could improve respiratory muscle~     function in mechanically ventilated patients commencing a CPAP trial.~   "
102044|NCT01721421|"~     Design: Prospective randomised cross-over study. Fifty-two eligible patients will be~     randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and~     following a washout period of 4 weeks, switch to the alternative treatment time for an~     additional 24 weeks.~      Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours~     thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from~     baseline in outcome measures over a total 12-month period.~      Primary outcome measure~      1]Serum albumin~      Secondary outcome measures Nutritional status~        1. Malnutrition-inflammation score~        2. Dietary intake~        3. Hand-Grip strength~        4. Energy expenditure~      Quality of life~        1. Patient reported quality of life and~        2. time to recovery from dialysis~      Serum biomarkers~        1. BNP~        2. Troponin~        3. MCP-1~      Others 24- hour Ambulatory blood pressure 24-hour accelerometer~      Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on~     haemodialysis treatment Duration: Fifty-six weeks~   "
102045|NCT01721408|"~     This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin~     in hospitalized patients with a complicated intra-abdominal infection.~   "
102046|NCT01721395|"~     Cough is a frequent symptom in children and infants and is one of the most common reasons~     parents visit a healthcare provider for their child. The US Food and Drug Administration has~     issued a warning that over-the-counter cough and cold medicines including antihistamines,~     decongestants, anti-tussives, and expectorants should not be administered to children~     younger than 2 years of age due not only to lack of proven efficacy, but also because of~     important safety concerns. Honey, another method of soothing cough cannot be used in~     children <1 year due to concerns for infantile botulism. A preparation from agave syrup has~     been created to address the need for an infant cough syrup. Although no studies have~     formally evaluated the use of agave nectar for nocturnal cough associated with Upper~     Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide~     some relief from cough in children.~   "
102047|NCT01721382|"~     This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes~     but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose~     regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),~     will be performed at baseline and again ~4 weeks after treatment with study drug. We will~     also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before~     each time the MMTT/OGTT are performed. Several hormones that may affect the way the body~     regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will~     assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine~     has on the hormones measured during the OGTT and MMTT.~   "
102048|NCT01721369|"~     The SYNCAT study intention is to study the level of adherence of the centers in Cataluña tu~     the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact~     that following them can have in the prognosis of these patients.~   "
102049|NCT01721356|"~     Emotional Intelligence (EI) is defined as the ability to accurately perceive and identify~     emotions in oneself and others, understand and use emotions to enhance cognitive processes,~     and effectively manage one's own emotions as well as those of others. Two major approaches~     to the construct of emotional intelligence have emerged. These two approaches can be broadly~     defined as the Trait and Ability Approaches. The Trait Approach, which is typically assessed~     via self-report measures such as that Bar-On Emotional Quotient Inventory, appears to be~     strongly related to existing models of personality and coping. The other major approach to~     EI follows an Ability Model, assuming that EI is similar to but distinct from other types of~     cognitive intelligence, and involves measurement of a variety of skills and abilities~     related to emotional processing. An understanding of the neurobiological substrate of~     emotional intelligence is beginning to emerge. One influential theory that is particularly~     relevant to the neurobiology of emotional intelligence is the somatic marker hypothesis,~     yet there still remains a limited understanding of the neurobiological basis of EI. The~     proposed investigation will attempt to provide the most comprehensive study to date~     examining the behavioral, psychological, functional, and brain structural correlates of EI.~     The proposed study will use neuroimaging techniques to examine the relationship between~     current measures of EI, behavioral expression of emotionally competent capacities, brain~     functional responses, and structural cerebral organization.~      The specific questions to be addressed and their associated hypotheses are:~        1. The two major approaches to EI (i.e., Trait vs. Ability) will show only modest, though~          significant positive correlations with one another.~        2. EI Trait measures will be highly correlated with measures of personality but weakly~          correlated with specific skills such as facial affect identification, emotional~          decision-making, and affectively based judgments, whereas EI Ability measures will~          correlate more highly with specific emotional skill measures.~        3. During functional MRI affective challenge tasks, EI scores will be negatively~          correlated with activity within the Somatic Marker Circuitry suggested by Damasio and~          colleagues (i.e., ventromedial prefrontal cortex, amygdala, insular cortex), as~          suggested by the neural efficiency hypothesis.~   "
102050|NCT01721343|"~     This randomized clinical trial studies collaborative targeted case management in improving~     functional status in patients with stage III-IV cancer. Collaborative targeted case~     management may improve functional status and preserve performance in patients with advanced~     cancer~   "
102071|NCT01721057|"~     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily~     (QD) is superior to placebo in the treatment of participants with moderately to severely~     active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at~     least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate~     response] participants) and who have not received a biologic disease-modifying antirheumatic~     drug (DMARD).~   "
102051|NCT01721330|"~     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective~     in treating ADHD in adults. Medications that increase dopamine are often effective~     treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases~     dopamine in the brain. The investigators predict that naltrexone as a monotherapy will be~     effective for ADHD symptoms in adults with ADHD.~      The investigators also plan to assess the effects of naltrexone on dopamine as measured by~     changes in serum prolactin. The investigators predict that naltrexone will increase dopamine~     as indexed by decreases in serum prolactin. This study will be a six-week, double-blind,~     placebo-controlled pilot study with adults 18-55 years of age with ADHD.~   "
102052|NCT01721317|"~     This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy,~     safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892)~     compared with placebo in adult subjects with partial-onset seizures (POS). This randomized,~     double-blind, placebo-controlled, parallel-group, multicenter study will compare~     ezogabine/retigabine IR (investigator-selected daily doses of 600 milligram (mg)/day, 750~     mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day) with placebo. Study drug will be taken three~     times a day (TID) in equally or unequally divided doses.~      The study design includes up to a 10-week (wk) Screening (≤2 wks)/Baseline (8 wks) Phase, a~     Titration Phase (2 wks), Dose-Optimization Phase (8 wks), Maintenance Phase (8 wks), and~     Taper/Follow-Up Phase (3 wks). The total duration of the study for each subject will be~     approximately 31 wks, and at minimum approximately 27 wks if subjects provide reliable~     28-day retrospective seizure data.~      Approximately 280 subjects will be screened with approximately 208 subjects randomly~     assigned to 1 of 2 treatment groups in a 2:1 ratio (ezogabine/retigabine IR, or placebo).~      Subjects will be instructed to start investigational product (IP) the day after the baseline~     visit. During the first week of the Titration Phase, subjects will be taking 300 mg/day (100~     mg TID). During the second week, subjects will be taking 450 mg/day (150 mg/day TID).~      At the beginning of the Dose-Optimization Phase (3rd week of study drug) subjects will take~     600 mg/day (200 mg TID) for one week. Thereafter during the Dose-Optimization Phase,~     subjects will continue to increase their daily dose by 150 mg per week until they have~     achieved their optimal tolerated dose. During this phase, the investigator may choose to~     have the subject stay on his/her designated dose for another week before attempting a dose~     increase until reaching a dose of 1200 mg/day. In addition, in the context of tolerability~     issues, the subject may be reduced to the preceding dose level for one week before~     attempting to increase the dose again at the next scheduled time point until the subject~     reaches optimal dose. Subjects unable to tolerate a minimum of 600 mg/day will be~     discontinued from the study.~      The Maintenance Phase will begin at Week 10 (Visit 8) and will last 8 weeks. During the~     Maintenance Phase, subjects will remain on the daily TID dose achieved at the end of the~     Dose-Optimization Phase.~      Seizure type and frequency will be monitored throughout the study via a Seizure Calendar and~     will be evaluated at each study visit. Subjects will be instructed to complete the daily~     Seizure Calendar during each phase of the study.~   "
102053|NCT01721304|"~     The purpose of this study is to determine if using a computer survey about preferences for~     treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient~     satisfaction with clinical care and decision making. This study is a two-part study. The~     first pilot tests the computerized tool to ensure it is understood by patients, then the~     second part is a randomized study (computerized tool versus usual care) to see if~     improvements are made in satisfaction and if there are reductions in decision regret.~   "
102054|NCT01721291|"~     Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties~     because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to~     provide relief from breathlessness. However, current inhalers are inefficient as they~     deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways.~      In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive~     tracer to track them. We will take images of the lungs to see if the fine-mist droplets~     reach the deep airways, and assess if this improves the breathing capacity in our patients.~     Our research may allow the development of new, more efficient inhalers to improve treatment~     for patients with COPD.~   "
102055|NCT01721278|"~     Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring~     function. Many different implants can be used in artificial hip joints.~     Hydroxyapatiteceramic (HAC) coating has become a well established The JRI Furlong® HAC~     femoral stem is one such implant with good long term survivorship. The femoral implant has~     been used since 1985 and published findings have shown a 97.4% survivorship at a mean of 17~     years follow up in patients. The Furlong Evolution® design is based on the tried and tested~     Furlong HAC but with some modifications.~      This is a 10 year multicentre clinical surveillance study, which aims to assess the~     clinical, functional and radiological performance of the Furlong Evolution® Hip stem in~     human patients.~   "
102056|NCT01721265|"~     All subjects in this study have previously been in an Idenix HCV study and received study~     drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study~     will not be enrolled in this study.~      In this study, researchers will try to find answers to these questions:~        -  How much (if any) hepatitis C virus is in your blood after stopping your Idenix study~          drug?~        -  Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or~          similar drugs?~   "
102057|NCT01721252|"~     The aim of this study is to determine prospectively the value of a recently identified~     proteomic signature in identifying those patients with lung cancer, who are likely to~     benefit from and respond favourably to erlotinib therapy.~      This is a prospective study of serum proteomics as a predictor of response to erlotinib~     therapy.~   "
102058|NCT01721239|"~     In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units.~     There is evidence to former intensive care patients have a significant symptom burden that~     affect recovery, function and activity for up to several years after admission to the~     intensive care unit. For the individual patient involves the low quality of life, delayed~     recovery, prolonged illness and healing process, and increased mortality. It requires that~     health professionals should provide support so patients quicker return to their usual life.~     Follow-up interviews with the staff after hospitalization in ICU have been shown to support~     the patient and identify individual needs and symptoms that can lead to more realistic~     expectations and increased well-being after admission in ICU. Follow-up in Denmark is being~     inconsistent in both the number of hospitals that offer this service, and in the offered~     type of service. Follow-up interviews with and without diaries suggest to improve physical~     and mental well-being and health, with limited scientific evidence of the efficacy of these~     interventions. We will investigate the effect of a standardized follow-up program after~     admission to the intensive care unit, consisting of written information, patient photos~     taken during hospitalization and three follow-up calls compared with standard care~     (discharge without follow-up).~      During a clinical study conducted in several intensive care units in Denmark examined~     whether follow-up calls can improve patients' well-being and health, as well as the meaning~     of the follow-up program has on the patient's everyday life in the first year after~     hospitalization in the ICU.~      The investigation contribute knowledge to the international research by revealing symptom~     burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in~     order to be able to target rehabilitation efforts and improved the quality of life. It will~     be innovative to use the results from a clinical study as a foundation for a database, and~     the method can serve as a precedent for evidence-based introduction of guidelines, database~     registration and create the groundwork for future research in intensive care. This study is~     expected to be profitable to society by preventing frequent readmissions, reduce medication~     costs and fewer referrals to specialists and have a positive effect on retention to the~     labor market. This will provide overall better use of society's expenses.~   "
102059|NCT01721226|"~     The purpose of this study is to determine whether an intervention (CARE+ Corrections)~     delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and~     recently -released ex-detainees in the community can improve linkage to community HIV care~     and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral~     suppression following community re-entry.~   "
102060|NCT01721213|"~     As part of a European post-marketing commitment, GSK will conduct a survey of physicians'~     and patients' understanding of the significant risks associated with Trobalt™ (retigabine),~     as described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of~     the surveys is to evaluate the effectiveness of the educational plan as specified in the~     European Risk Management Plan (RMP).~      The objectives of this study are to assess patients' and prescribers' understanding and~     knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey~     instrument.~      This is a cross sectional survey of:~        1. 250 patients recruited from across the following countries (United Kingdom, Sweden,~          Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany~          who are currently using or have filled a prescription for Trobalt™ at least once in the~          last 3 months.~        2. 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the~          last 3 months, and who were on the list to which a letter containing the Physician's~          Guide for Trobalt™ was distributed from across the following countries (United Kingdom,~          Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the~          neurologists will have prescribed Trobalt™. The survey will also aim to include up to~          100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™.~      Patients eligible for the survey will be asked to take the survey online or via a telephone~     interview if the latter is preferred. Neurologists will be invited to take the survey~     online.~      The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark,~     United Kingdom, Switzerland and Sweden) and an additional three countries with launch in~     2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The~     selection of countries includes Switzerland, which is not part of the European Union.~     However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale~     for surveying the first five countries to launch is so that any issues identified from these~     countries regarding the effectiveness of the Physician's Guide and PIL in communicating the~     risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised~     in a timely manner. In addition, these countries are likely to provide the greatest number~     of neurologists with experience of prescribing Trobalt™, and their patients.~      The primary outcome of the survey is the proportion of patients/neurologists providing~     correct responses to a series of questions concerning the significant risks associated with~     Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the~     Physician's Guide.~   "
102061|NCT01721200|"~     This study is a randomized controlled trial designed to examine the efficacy of an~     educational decision support tool for patients with rheumatoid arthritis who continue to~     have active disease despite use of traditional disease modifying drugs. The study will take~     place at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by~     the treating physician and those providing consent will be randomized to usual care versus~     use of the decision support tool.~   "
102062|NCT01721187|"~     Using fMRI, this study will explore the neural correlates of satiety when individuals make~     decisions about food. The investigators will also examine individual differences in satiety~     effects.~   "
102063|NCT01721174|"~     Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile~     duct cancers, and its development can hinder the use of chemotherapy, decrease patient~     quality of life, and decrease survival. To relieve obstructive jaundice as a result of the~     obstruction, endoscopic stent placement is usually required. The use self-expandable metal~     stents (SEMSs) have been shown to result in a longer patency times as compared with plastic~     stents. However, despite improvements in materials and stent design, stent obstruction still~     occurs in 13% to 44% of the patients. Tumor in-growth is the most common mechanism of stent~     obstruction.~      Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described~     in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.~     The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening~     of the bile duct lumen. The procedure has the potential of reducing the rate of stent~     obstruction after SEMS and also prolonging survival. The safety profile appears to be~     comparable that of placement of SEMS alone without added complications (<10%). The aim of~     the current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS~     alone in a randomized controlled trial.We hypothesize that the application of EBRFA can~     reduce recurrent biliary obstruction after SEMS.~   "
102064|NCT01721161|"~     The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with~     their first episode of unilateral acute optic neuritis (AON). The secondary objective of~     this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in~     this study population.~   "
102065|NCT01721148|"~     There is a great need for new therapies for carcinomas that have progressed on or not~     responded to current therapy. There are no approved Met targeted agents in standard clinical~     use. In the population of subjects with advanced carcinomas that are unresponsive to~     standard of care, and based on the relatively safe, reversible and monitorable toxicity~     profile of ASLAN002 in non clinical studies, the potential for benefit from ASLAN002~     outweighs the potential risks for toxicity.~      The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects~     with advanced or metastatic solid tumours, as well as to define the overall safety profile~     of ASLAN002.~   "
102066|NCT01721135|"~     This study is a randomized, placebo controlled, four way crossover, in which the the effect~     of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course~     of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin~     400mg (single dose) with a weeks washout prior to starting the next course. Key assessments~     include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by~     blood pressure, heart rate, clinical laboratory safety tests and collection of adverse~     events .~   "
102067|NCT01721109|"~     This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)~     single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive~     adolescents. Safety, tolerability, and efficacy will also be evaluated through Week 48.~      A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive~     EVG/COBI/FTC/TDF as follows:~        -  Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state~          PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15~          and at least 4 participants 15 to < 18 years of age.~        -  Part B: Following confirmation of EVG exposure in at least 12 participants from Part A,~          34 to 38 participants in addition to those enrolled in Part A will be enrolled to~          evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.~   "
102068|NCT01721096|"~     The objectives of the PMS are to observe the frequency, type, and degree of device~     deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to~     collect information on evaluation of the efficacy and safety for reevaluation.~   "
102069|NCT01721083|"~     This study is designed to compare two different styles of intramuscular injection (Bunch~     versus Z-Track)during flu vaccination with the following outcome measures as basis for~     comparison: perceive pain, redness, medication leakage, other complications within 72 hours~     in healthy adult volunteer subjects.~   "
102070|NCT01721070|"~     Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following~     sublingual administration of sufentanil NanoTab.~   "
123191|NCT01443208|"~     To evaluate the pharmacokinetics and safety of single dose and multiple doses of~     desvenlafaxine in Korean healthy subjects and compare to westerners.~   "
102073|NCT01721031|"~     Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is~     defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may~     cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve~     block (DPNB) was applied for penile surgery including circumcision and some anterior urethra~     surgery. The investigators hypothesize that DPNB relive CRBD for male patients with~     indwelling urinary catheter under general anesthesia.~   "
102074|NCT01721018|"~     HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the~     RL1 gene which encodes the protein ICP34.5.~      Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and~     peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed~     to asbestos, although it typically occurs decades after exposure (10-40 years later).~     Malignant pleural mesothelioma forms plaques that are distributed on the surface of the~     pleural space in the lung. Approximately 30% of patients require an indwelling pleural~     catheter for drainage of pleural effusions. In this patient group, the indwelling catheter~     may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.~      This study seeks to evaluate the safety and biological effects of single and multiple~     administrations of HSV1716 in the treatment of malignant pleural mesothelioma.~   "
102075|NCT01721005|"~     The aim of this study is to evaluate the feasibility of patient education on feeling the own~     pulse irregularity in the elderly population of Lieto.~      Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like~     palpitation and discomfort but especially in elderly population there's significant quantity~     of persons who don't feel any symptoms and fail to seek for medical care for stroke~     prevention.~      The main objectives in this study are to find out the prevalence of AF in the elderly~     population of Lieto, to assess the feasibility and reability of patient education on feeling~     one's pulse irregularity and the affect to the quality of life of the participating subjects~     and monitoring the possible increased burden to the public health care system.~      The study contains two office visits with specified learning session and long-term~     phone-call follow-up.~   "
102076|NCT01720992|"~     Background: Shamshuipo District has the highest proportion of low income families, and a~     relatively large percentage of single parents, elderly, new immigrants among all districts~     in Hong Kong (Census and Statistics Department, 2011). In addition to provide these families~     substantial support, a campaign to enhance their family well-being is needed.~      Aim: This project is conducted to enhance their family relationship as well as family~     happiness, health and harmony (3Hs) among families in the Shamshuipo District, through a~     community-based intervention programme combined with a planning tool (booklet).~      Methods: This project adopts a cluster-randomized controlled design, with the application of~     positive psychology concepts as a theoretical framework. A community-based participatory~     (CBP) approach, which is an effective way to engage public health researchers and community~     members (NGOs, other major stakeholders, and participants), will be used. Both quantitative~     and qualitative methods will be used in the evaluation of major outcomes (participants'~     family relationship and 3Hs) at different time points throughout the project. Process~     evaluation will be performed to evaluate the process of each component of the project.~      Procedure: This project will be conducted in three phases.~      Phase 1 includes planning, implementation, and evaluation of a training programme for social~     workers from the 30 participating NGOs. The social workers will be equipped with the~     knowledge and skills of the application of positive psychology as well as logic model. This~     phase also includes the launching event to arouse public awareness of the project.~      Phase 2 includes designing, delivering, and evaluating 30 community-based intervention~     programmes. A planning tool (designed as a booklet) will be distributed to participants of~     the intervention group in the form of 'homework assignment' immediate after the intervention~     programme; whereas participants of the control group will receive the booklet upon the~     completion of the three months follow-up questionnaire assessment. This phase also contains~     focus group interviews among participants to collect their experiences, feelings and changes~     in families after attending the intervention programme. Focus groups among social workers~     will be conducted afterwards to explore their barriers and facilitators in programme~     implementation; as well as their personal and/or collective growth in conducting the~     project. In-depth interview among community stakeholders will be held to explore the social~     impact of the CBPR project, and collect their suggestions for future implementation.~      Phase 3 is a dissimilation phase that the Positive Family Education Booklet and Positive~     Family Practice Manual will be released. A practice wisdom forum for social workers and~     other major stakeholders will also be organized to share their experiences in conducting the~     community-based programmes.~      Primary hypothesis: Families participated in a community-based programme and received a~     toolkit (intervention group) have higher scores in their family relationship and family 3Hs~     than families who participated in a community-based programme only (control group).~      Secondary hypotheses: (1) Participants' attitudes towards and intention of practising the~     suggested behaviours will be increased immediately after their participation in the~     community-based intervention programme; (2) Participants' attitudes towards, their~     intention, as well as frequency of practising the suggested behaviours will remain higher at~     6 weeks and 3 months after the intervention compared to the corresponding figures of~     pre-intervention (baseline); (3) Participants' scores of family relationship and 3Hs will be~     significantly higher at 6 weeks and 3 months after their participation in the intervention.~   "
102077|NCT01720979|"~     Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature~     suggests a pivotal role for attentional functioning in neurocognitive and behavioural~     consequences of paediatric TBI. Limitations of traditional neuropsychological measures of~     attentional functioning have interfered with identification of the effect of paediatric TBI~     on attentional networks so far. Moreover, the associations between attentional networks,~     learning abilities, academic performance and behavioural and emotional problems following~     paediatric TBI are yet to be explored.~   "
102078|NCT01720966|"~     Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion~     formation might be reduced by laparoscopic surgery, however sound evidence is lacking.~     Colorectal surgery would be a good clinical model to investigate adhesion formation between~     open and laparoscopic surgery because of the adhesion formation propensity of colorectal~     surgery. However, a randomized controlled study to provide direct evidence is unlikely~     because of large numbers of patients needed for such a trial and the difficulty to check for~     adhesion formation at second surgery. Therefore we investigate adhesion formation after~     laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.~      Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic~     versus open surgery for colorectal malignancies during liver resection for colorectal~     metastases.~      Study design: The study is designed as a prospective observational cohort study.~      Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for~     intended liver resection or radio frequency ablation for liver metastases of a colorectal~     malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.~      Main study parameters/endpoints:~        -  Primary endpoint is incidence of adhesions to the ventral abdominal wall around the~          site of the original incision.~        -  Secondary endpoints are episodes of bowel obstruction between index surgery and liver~          surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of~          adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative~          complications: enterotomy, seromuscular injury, inadvertent organ injury during~          adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: This study is an observational study. The existence of adhesions will be~     assessed during laparotomy or laparoscopy for the treatment of liver metastases. The~     laparotomy is indicated for medical treatment and should not be enlarged solely for the~     assessment of adhesions nor will the operating time be influenced for this purpose.~      Adhesions and peroperative complications have to be scored by the operating surgeon during~     or directly after surgery. The postoperative complications have to be scored during the~     postoperative course by the doctors on the ward. These assessments do not interfere with the~     treatment of the patients.~   "
102079|NCT01720953|"~     Purpose:~      Borderline personality disorder (BPD) is a complex psychiatric disease of uncertain~     aetiology and pathogenesis. A key mechanism of disease susceptibility and treatment response~     could be epigenetic changes in DNA methylation patterns. However, no study has yet~     demonstrated that psychotherapy can exert its therapeutic effect through epigenetic~     mechanisms. The main aim of this study is to analyze the promoter methylation pattern of~     genes considered to be related to the development and psychopathology of BPD, in particular~     the brain-derived neurotrophic factor (BDNF) and glucocorticoid receptor genes, and the~     effects of mentalization based treatment (MBT) on changes. Associations to changes in BDNF~     serum levels and salivary cortisol levels, as well as key components of BPD aetiology and~     core treatment targets in MBT, will also be investigated. Should epigenetic mechanisms have~     importance for BPD pathology and effects of treatment, there is potential use of DNA~     methylation patterns as valid biomarker measures of diagnosis, prognosis, and treatment~     response.~      Hypothesis:~      The formation and maintenance of symptoms in BPD is mediated through neuropsychiatric~     mechanisms that can be affected through psychological treatment. Specifically, aberrant~     epigenetic regulation of neuropsychiatric genes related to behavioural control and affect~     regulation, as well as BDNF and cortisol levels, is ameliorated by therapeutic processes.~      Method:~      Fifty female patients diagnosed with BPD will undergo a year of intensive MBT that is~     designed to target domains of BPD pathology. The patients will be assessed at baseline and~     every 6 months over the treatment period. Matched healthy control subjects will be assessed~     at 6 month intervals to compare changes in DNA methylation, BDNF serum levels, salivary~     cortisol levels, and neuropsychological test performance. To link components of the~     neuropsychiatric mechanisms underlying the onset of illness, course, and response to~     treatment, patients will undergo assessment of clinical symptoms, comorbidity patterns and~     psychosocial impairment. Patients and control subjects will at baseline undergo assessment~     for childhood trauma, self-harm, suicidal behavior, early maladaptive schemas, and~     personality traits, and within the 1-year study period also undergo continuous assessment~     for changes in symptoms of dissociation, depression, and personality dysfunction.~   "
102080|NCT01720940|"~     This study is being carried out to find out whether there is reduction in vancomycin-induced~     kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous~     infusion.~      This study will recruit 220 subjects from 2 hospitals over a period of 3 years.~      Participants are invited if they have an infection that requires prolonged vancomycin~     therapy (> more than 10 days).~   "
102081|NCT01720927|"~     GABHS are common etiological agents for acute pharyngitis. However, local data is limited~     and large scale surveillance studies have not been done. This study aims to evaluate the~     disease burden in the community due to GABHS.~      In this study, patients presenting with signs of acute pharyngitis will be evaluated.~     Patients with fulfilling the inclusion criteria will be tested for Rapid Antigen Detection~     test (RADT)~   "
102118|NCT01720446|"~     This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and~     other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is~     event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the~     accrual of major adverse cardiovascular events (MACE) in this trial and the remaining~     research programme. The incidence of MACE will be monitored throughout the trial which will~     be terminated according to plan when pre-specified stopping criteria are met.~   "
102082|NCT01720914|"~     In this prospective, multicenter observational study we assess the diagnostic validity of~     the following standard screening instruments for delirium regarding sedation, analgesia and~     ventilator status in critically ill patients:~        -  Confusion Assessment Method for the ICU (CAM-ICU)~        -  Intensive Care Delirium Screening Checklist (ICDSC)~        -  Nursing-Delirium-Screening-Scale (Nu-DESC)~      The definite delirium diagnosis (definite in terms of reference standard) is made according~     to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition,~     text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is~     the Gold Standard to diagnose delirium.~      Primary research question: Does sedation, ventilator status and analgesia influence the~     sensitivity of delirium screening tools (DST)?~   "
102083|NCT01720901|"~     To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients~     who progressed after gefitinib therapy.~   "
102084|NCT01720888|"~     Despite the recent advances in medical and surgical treatment, heart failure resulting from~     ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality.~     Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV)~     cavity with documented poor LV function as a result of severe coronary artery disease (CAD).~     LV remodelling which is inevitable after an infarct has been postulated to contribute~     largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is~     the goal for the treatment in patients with severe CAD. Cell therapy represents a novel~     therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A~     type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone~     marrow.This study aims to test the differentiation potential and therapeutic capacity of MSC~     from severe CAD patients after intracoronary implantation in an ischemic myocardial~     environment in Malaysian population.~   "
102085|NCT01720875|"~     Bortezomib is an established treatment in multiple myeloma; it is common practice in the UK~     to administer bortezomib with dexamethasone. This practice is based on data that supports~     improved response rates with this combination.~      Recent trial data indicates that the addition of vorinostat to bortezomib treatment~     overcomes treatment resistance to bortezomib. As such this current trial is designed to~     investigate the efficacy, safety and tolerability of combination treatment with vorinostat,~     bortezomib and dexamethasone in patients with relapsed and relapsed refractory myeloma.~      A comparison of this Phase II trial with the pivotal Phase III trial conducted by MSD (using~     the labelled bortezomib indication without dexamethasone) will address the impact of~     dexamethasone in regards to tolerability and additional efficacy in myeloma patients.~   "
102086|NCT01720862|"~     This research is being done to look at the association between migraine and obesity.~   "
102087|NCT01720849|"~     The aim of the study is to assess improvement in visual evoked potential, cognition,~     fatigue, micturation and walking impairment under 3 months of Fampyra treatment~   "
102088|NCT01720836|"~     All subjects will receive the vaccine subcutaneously every 3 weeks x 3 and then every 3~     months for 3 years. The rationale for using Poly-ICLC as an adjuvant are two ongoing trials~     at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one~     as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and~     the other in subjects with advanced colonic adenomas at risk for developing colon cancer.~     The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials.~     There has been no toxicity observed and the vaccine is highly immunogenic in early disease.~     In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.~   "
102089|NCT01720823|"~     It is often clinically impossible to differentiate children with an isolated snoring from~     those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based~     polysomnography. This expensive examination is poorly accessible due to appointments delays~     at hospital.~      Our study is designed to compare the characteristics of a home polysomnography versus~     standard polysomnography for the diagnosis of pediatric OSA.~   "
102090|NCT01720810|"~     This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and~     similar neurological disorder through obtaining longitudinal clinical and neuropsychological~     data. The long term goal is to have a well-characterized subject population to contribute to~     our understanding of the natural history, diagnosis and ultimate treatment of cognitive~     impairment in patients with PD and similar disorders.~   "
102091|NCT01720797|"~     The purpose of this research study is to assess the clinical effectiveness of the procedure~     of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth~     movement in patients undergoing orthodontic treatment. Accelerated tooth movement means~     that using the PROPEL™ device may help complete your treatment with braces on one side of~     your mouth sooner than would be expected if the device were not to be used.~   "
102092|NCT01720784|"~     Studies report that dietary fiber intake is inversely correlated with body weight gain.~     Previously, we have shown alginate fiber supplementation increases weight loss, which we~     ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One~     property of importance to appetite is the ability of alginate to gel in the acidic~     environment of the stomach. We hypothesize that the alginate will decrease the feeling of~     hunger and lower food consumption compared to control.~      Here we test three different beverages in a double-blinded crossover design, in which 24~     participants will be randomly assigned to the sequence of the test days separated by at~     least 5 days.~      On each test day appetite sensation as well as blood glucose and insulin will be measured~     over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta~     Bolognese will be served, and energy intake calculated. The participants will also rate~     gastrointestinal confort.~   "
102093|NCT01720771|"~     The aim of the prospective project is to investigate effect of daily probiotic supplements~     on dental caries development in preschool children living in a low socioeconomic immigrant~     area in souithern Sweden. The study design is a randomised controlled trial with two~     parallell arms. The intervention is one probiotic tablet or placebo once daily. The null~     hypothesis is that the caries experience and increment will not differ betwwen the two~     groups.~   "
102415|NCT01716559|"~     This observational, prospective, multicenter study will evaluate the treatment response rate~     and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy.~     In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be~     collected for 16 weeks.~   "
102094|NCT01720758|"~     The presence of a specific mutation in the gene known as B-RAF has been found in patients~     who have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be~     ascertained in peripheral blood samples of patients who have this disease and in a group of~     patients who have a similar chronic lymphoproliferative conditions such as splenic marginal~     lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis~     of Hairy Cell Leukemia and determine whether patients are in remission.~   "
102095|NCT01720745|"~     ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into~     the needle that has an air column. The needle is not flushed with any liquid prior to~     passing into the desired solid lesion. Suction is applied when the needle is within the~     lesion leading to aspiration of tissue into the needle. This is the standard technique and~     some have done with and without the stylet. There are some data that favor non use of a~     stylet.~      WET SCTION TECHNIQUE:~      Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the~     column of air with saline. The needle is now passed into the desired lesion. Suction is~     applied at maximal strength and needle moved back and forth within the lesion to obtain as~     aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves~     into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a~     stylet and or flushing air into the needle with a syringe.~      HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during~     fine needle biopsy may be significantly improved by filling the column of the needle with a~     less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the~     expansion of air within the needle. Replacing the air with sterile saline may thus improve~     the suction transferred to the needle tip by ensuring that the full volume of the vacuum~     syringe is transferred to the distal tip of the needle. This effect would be most pronounced~     in larger gauge needles which would have a larger internal volume. An additional benefit of~     filling the needle with saline prior to aspiration is the speed of the pressure transfer.~     The theory is that the air in the needle may absorb some of the force of the sudden~     application of vacuum. A column of saline in the needle may increase the velocity of the~     pressure transfer providing more tissue and less blood.~   "
102096|NCT01720732|"~     Evaluation of a short version of Narrative Exposure Therapy~   "
102097|NCT01720719|"~     The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E~     300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high~     LDL-C and non-alcoholic fatty liver disease.~   "
102098|NCT01720706|"~     This is a clinical research study designed to determine the safety and efficacy of the~     application of a unique interstitial radio frequency thermal therapy for the treatment of~     large tumours in the kidney or liver. The novel device offers patients a more effective~     therapy than conventional RFA and for patients with large tumours fewer number of treatments~     and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will~     be determined by a combination of biopsy and contrast enhanced CT imaging.~      The study will assess if novel device can produce lesions in the liver or kidney in a~     controlled and predictable manner and with sufficient size to effectively manage disease~     progression in the organ. The extent of lesion size at a delivered power setting and~     treatment time will be measured with post-treatment CT or MRI and biopsy as measures of~     tissue response~   "
102099|NCT01720693|"~     Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the~     standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent~     studies, partial nephrectomy provides equivalent oncologic, and superior functional,~     outcomes compared with the standard radical nephrectomy over the short and long term (2, 3).~     Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve~     hilar clamping, which creates the desired bloodless operative field, allowing for more~     precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to~     ischemic kidney injury which can compromise the functional outcomes of the remaining~     kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving~     partial renal arterial clamping, with the goal of completely eliminating surgical ischemia~     to the renal remnant.~   "
102100|NCT01720680|"~     -  Title: Open-label, prospective exploratory study to assess the effects of the~          AlphaCore® device on central and peripheral airway dimensions in patients with COPD.~        -  Indication: COPD patients~        -  Study Design: Open-label, prospective design~        -  Study Phase: II~        -  Test treatment duration: 1 day~        -  Test treatment: AlphaCore® device~        -  Dosage regimen: 1 session of stimulation during 90 seconds~        -  Patient number: up to 10 evaluable patients with COPD~        -  Patient age: ≥ 18 years~        -  Sex: male or female~        -  Primary objective: The evaluation of the effect of the AlphaCore® device on central and~          peripheral airway dimensions with Computational Fluid Dynamics (CFD).~        -  Secondary objectives: The assessment of the effect of the AlphaCore® device on lung~          function (spirometry, diffusion and resistance) and on patient reported outcomes~          (PRO`s).~   "
102101|NCT01720667|"~     A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants.~     Current treatments for the brain damaging complication of neonatal seizures are~     unsatisfactory.~      Monitoring for seizure detection will be tested at five (5) US sites and one (1)~     international site using the internet.~   "
102102|NCT01720654|"~     Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent~     gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for~     use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner~     management with heterosexual patients, but note the absence of evidence necessary to make an~     equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess~     the impact of EPT on partner notification, treatment, and STI re-infection among MSM are~     critical to the development of evidence-based partner management guidelines.~      Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea~     and chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests~     that frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual~     networks may be a factor contributing to the persistently high incidence of HIV infection~     among MSM in the region. The investigators propose a pilot evaluation of the effect of EPT~     on partner notification and treatment among MSM in Peru diagnosed with gonorrhea or~     chlamydia at any anatomic site.~      Specific Aim 1: To explore the social norms and structural factors influencing partner~     notification and treatment among MSM in Peru.~      Specific Aim 2: To determine the effect of EPT on anticipated and actual partner~     notification among MSM diagnosed with gonorrhea or chlamydia infection.~      Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial~     re-infection among MSM randomized to receive EPT compared with standard partner notification~     counseling.~      The proposed study will provide pilot data on the use of EPT with MSM diagnosed with~     gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT~     as an STI control method among MSM in Latin America.~   "
102119|NCT01720433|"~     Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as~     causes of post-operative morbidity. This prospective, double-blind, randomized controlled~     trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by~     implementing a simple intra-operative technique.~      Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or~     laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be~     randomized to either the current standard (control group) or to receive an intervention to~     remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the~     end of the operation, by placing the patient in the Trendelenburg position and utilising a~     pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of~     60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of~     the procedure by passive decompression via the open operative ports.~   "
102103|NCT01720641|"~     The goal of the proposed research is to assess new strategies for partner management and~     sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who~     have sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated~     within the core risk group of MSM. STI infection and re-infection are central to the~     continuation of the HIV epidemic among MSM in Peru. Development of improved strategies for~     partner notification and treatment will reduce the incidence and prevalence of STIs and~     ultimately reduce the incidence of HIV infection in this population. The first phase of this~     study used qualitative methods to explore attitudes and practices related to partner~     notification among MSM in Lima, Peru. Findings from the qualitative research were used to~     develop a quantitative survey instrument to assess partner notification decision-making~     processes and practices among MSM in Peru recently diagnosed with HIV or syphilis infection.~     Data from both quantitative and qualitative phases of the study have been used to develop a~     partner notification for MSM in Peru. Investigators plan to implement and assess the impact~     of the intervention on rates of partner notification following a diagnosis of syphilis among~     MSM in Lima, Peru. The investigators hypothesize that participants randomized to receive one~     or more partner notification tools will report a higher frequency of partner notification.~   "
102104|NCT01720628|"~     Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial~     dysfunction plays a prominent role in the pathogenesis of the disease, we considered~     angiogenic cytokines as an interesting target for investigation in BD. The aim of this study~     was to investigate the possible role of angiogenin, vascular endothelial growth factor~     (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.~      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were~     included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by~     using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.~   "
102105|NCT01720615|"~     The objective of the present investigation is to analyze EEG and auditory evoked potentials~     at the transition from consciousness to unconsciousness and vice versa. A set of~     electroencephalographic and auditory evoked potential parameters should be identified that~     allows separation of consciousness from unconsciousness (reflected by~     responsiveness/unresponsiveness to command). The study is based on data of 80 patients~     undergoing general anesthesia with remifentanil and either sevoflurane or propofol.~   "
102106|NCT01720602|"~     This pilot clinical trial studies vorinostat in treating patients with stage IV breast~     cancer receiving hormone therapy. Vorinostat may help hormone therapy work better by making~     tumor cells more sensitive to the drug.~   "
102107|NCT01720589|"~     The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich~     in medium chain triglycerides on energy expenditure and food intake in overweight and obese~     children.~   "
102108|NCT01720576|"~     This is a study to assess the safety and tolerability of subcutaneously administered~     REGN1033 (SAR391786) in healthy volunteers.~   "
102109|NCT01720563|"~     Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were~     betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization~     (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was~     higher than the 8-11% reported in the Western populations and was related to oral submucous~     fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in~     patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with~     cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in~     stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced~     myelosuppression. It also improved the Quality of Life, especially in fatigue, among~     advanced cancer patients. This study will be investigated the effect of PG2 Injection in~     relieving the adverse events of concurrent chemoradiotherapy, such as fatigue,~     myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and~     chemotherapy in treatment of patients with advanced pharyngeal or laryngeal SCCHN.~   "
102110|NCT01720550|"~     The objective of this study is to conduct a trial in the spirit of providing as much as~     possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and~     safety of different doses of PG2 treatment for relieving fatigue among advanced cancer~     patients who are under standard palliative care (SPC) at hospice setting and have no further~     curative options available. Patient's fatigue status, to be measured by the Brief Fatigue~     Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement~     response rate among patients between two study arms will then be compared as the basis for~     efficacy evaluation at the end of the first treatment cycle, and will be the primary~     endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores~     change from baseline among patients within and between cycles will be included in the~     secondary efficacy endpoints, and will be compared between two study arms. Patients' quality~     of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be~     also measured by 11 questions (SS11) from EORTC(European Organization) for Research and~     Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints~     include Karnofsky performance scores, and weight change and its related c-reactive protein~     level of the patients.~   "
102111|NCT01720537|"~     This study is to evaluate the safety, tolerability and immunogenicity of single, ascending~     or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to~     hypercholesterolemic subjects when added on to a daily statin dose.~   "
102112|NCT01720524|"~     This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide~     treatment and reduce the failure rate of available treatments for persistent pulmonary~     hypertension of the newborn.~   "
102113|NCT01720511|"~     This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and~     insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The~     safety and tolerability of purple rice is similar to white or brown rice, but contains the~     purple elements common to other foods like grapes.~   "
102114|NCT01720498|"~     To find out the effect site concentration of remifentanil for preventing QTc interval~     prolongation during intubation under propofol-remifentanil anesthesia in elderly patients~   "
102115|NCT01720485|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of Moderate - Severe Persistent Allergic~     Rhinitis in Adults.~   "
102121|NCT01720407|"~     Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on~     photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to~     Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although~     surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10~     mm) excision for a localized tumor on the face.~      Several studies have shown that imiquimod, activating local immunity by interferon~     production, induced LM or MLM regression and could also decrease the frequency of relapses.~      The principal aim of our project is to study the effect of imiquimod versus vehicle in~     pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the~     first surgical procedure, and the frequency of short and medium term recurrence of LM.~     Furthermore, the improvement in patient quality of life could also be significant.~   "
102122|NCT01720394|"~     The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter~     for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not~     greater than 6) compared to medical treatment using a dinoprostone~     slow-release-vaginal-insert.~   "
102123|NCT01720381|"~     The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose~     levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the~     Gem 3000, the reference standard for Erasme University Hospital.~   "
102124|NCT01720368|"~     The investigators believe that patients with Crohn's disease are able to report details of~     their own medical history accurately and record changes in clinical status effectively over~     time. Using an internet-based database the investigators will ask patients to report their~     own disease history, and the investigators will compare their reports to the medical record.~   "
102125|NCT01720355|"~     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse~     subject population during severe signal interference over a specified saturation range.~   "
102126|NCT01720342|"~     The EASE Enable study is intended to collect additional data on the clinical outcomes of the~     Medtronic Enable® Aortic Bioprosthesis in real world patients.~   "
102127|NCT01720329|"~     The goal of this study is to assess the feasibility of randomizing residents of long-term~     care facilities to either probiotics or placebo to assess whether probiotics can reduce~     influenza and other viral laboratory confirmed respiratory infection.~   "
102128|NCT01720316|"~     The purpose of this study is to assess the efficacy of oral glycine as an augmentation~     strategy in two psychotic patients with a triplication (4 copies) of the gene glycine~     decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical~     trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg,~     administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week~     period of no treatment will occur between treatment arms. A 6-week period of open-label~     glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow~     the double-blind placebo-controlled clinical trial. Prior to the double-blind~     placebo-controlled clinical trial and at the end of the open-label glycine trial, the~     following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI~     (3T), steady-state visual evoked potentials, and EEG. Positive, negative, and affective~     symptoms and neurocognitive function as well as plasma levels of large neutral and large and~     small neutral and excitatory amino acids and psychotropic drug levels will be assessed~     periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a~     glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder~     (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital~     Pharmacy.~      Because the results of the double-blind placebo-controlled and open-label glycine treatment~     arms showed substantial clinical benefit to the participants, the study has been extended to~     include six months of chronic open-label glycine in order to determine 1) whether the~     clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are~     lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for~     this extension will be provided by Letco Medical.~      The investigators hypothesize that mutation carriers will have reduced endogenous brain~     glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine~     administration will increase brain glycine in the two carriers, but to a lesser extent than~     in non-carrier family members and controls.~      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs~     modulated by NMDA in mutation carriers compared with non-carrier family members and~     controls.~      The investigators hypothesize that glycine, but not placebo, will improve positive, negative~     and affective symptoms as well as neurocognitive function.~      The investigators also hypothesize that open-label glycine will improve clinical and~     cognitive functioning, will partially normalize decreased baseline glycine and GABA and~     increased glutamate and glutamine, and will partially normalize magnocellular pathway~     activation and abnormal evoked potentials.~   "
102129|NCT01720303|"~     This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug~     (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not~     adequately controlled on the current OAD therapy.~   "
102130|NCT01720290|"~     This trial is conducted in Asia. The aim of this trial is to compare repaglinide and~     metformin administered alone or in combination in subjects with type 2 diabetes.~   "
102131|NCT01720277|"~     The purpose of this pilot evaluation is to help determine the feasibility and power needed~     to prospectively evaluate relative effectiveness of high dose influenza vaccine in~     preventing influenza mortality and hospitalization in a nursing home population in the U.S.,~     compared to the standard dose influenza vaccine.~   "
102132|NCT01720264|"~     The main purpose of this trial is to assess the efficacy and safety of sitagliptin in~     enhancing engraftment following umbilical cord blood transplantation (recovery of blood~     counts after transplant).~   "
102133|NCT01720251|"~     The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal~     treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic~     rhinoconjunctivitis during the following birch pollen season~   "
102134|NCT01720238|"~     Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased,~     patients who had been chronically infected with HBV, especially those with liver cirrhosis~     cause great burden on public health care. In view of economic development level, drug~     availability and lack of independent health economics evidence, the investigators are still~     unable to give specific guidelines for HBV related compensated liver cirrhosis in China.~     Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of~     two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through~     this prospective, open-label, multicenter and nonrandomized study.~   "
102135|NCT01720225|"~     The goal of this clinical research study is to compare how two different drugs, decitabine~     and azacitidine, when given on a shorter than standard dosing schedule can help to control~     MDS. The safety of the drugs will also be studied.~      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause~     cancer cells to die.~      Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the~     function of the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting~     genes may be able to work better. This could cause the cancer cells to die.~   "
102136|NCT01720212|"~     To evaluate the safety and plasma concentration change of YM178 after single- and~     repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.~   "
102138|NCT01720186|"~     This is a pilot study, single-center, prospective, open-label, to assess the acceptability~     and performance of the experimental medical device (SPI) used during an imaging examination~     (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its~     own control, since the imaging examination will be synchronized simultaneously with the two~     systems: tested Medical Device (SPI) and reference Medical Device(RPM).~   "
102139|NCT01720173|"~     This phase II trial studies the side effects and how well dalantercept works in treating~     patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that~     has returned. Dalantercept may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Dalantercept may also stop the growth of tumor cells by~     blocking blood flow to the tumor.~   "
102140|NCT01720160|"~     The purpose of this research study is to show whether the Neo system is safe and works in~     people with heart failure. The study is currently in long-term follow up.~   "
102141|NCT01720147|"~     Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone~     marrow failure (BMF), congenital abnormalities and a predisposition to malignancy.~   "
102142|NCT01720134|"~     Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high~     cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive~     Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher~     than the 1% after natural conception, related to the number of embryos transferred, and~     preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh~     ART cycles are reimbursed for female patients younger than 43 with a Belgian insurance~     number since July 2003, but only if a limited number of embryos is transferred depending on~     female age and cycle rank. Although this policy has resulted in a significant reduction in~     the MPR after ART in Belgium from 24 % to 13 %, available data are cycle based and it is~     unknown if the cumulative delivery rate per patient is affected by this legislation. The aim~     of this study was to test the hypothesis that Belgian ART legislation since 2003, coupling~     lab reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when~     compared to the situation before 2003.~   "
102143|NCT01720121|"~     This study is randomized clinical trial to verify the effect of nursing guidelines for~     patients undergoing left cardiac catheterization on an outpatient basis. Comparing three~     approaches to direct guidelines about the procedure:~        -  printed,~        -  digital video disc (DVD)~        -  conventional guidelines provide by nursing team~   "
102144|NCT01720108|"~     In this study the investigators want to look at whether using aspirin instead of rivaroxaban~     (after initial treatment with rivaroxaban) works as well at preventing blood clots while~     also reducing risk of bleeding and is more cost effective in patients who have either a~     total hip replacement or total knee replacement.~   "
102145|NCT01720095|"~     The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to~     antipsychotic medications will it help maintain or improve cognitve functioning.~   "
102146|NCT01720082|"~     Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women~     affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this~     subgroup is high. Since the dissemination of single access surgery (no-scars surgery)~     ameliorated outcome has been supposed in these patients regarding post-operative pain,~     hospital stay and cosmetics results, and keeping the same safety as LA. This randomized~     controlled study is supposed to give answers to these questions.~   "
102147|NCT01720069|"~     To evaluate the clinical efficacy, safety, tolerability and dose-response relationship,~     using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice~     daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe~     persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global~     Initiative for Asthma (GINA) guidelines 2011.~   "
102148|NCT01720056|"~     Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard~     treatment is yet to be clarified. This randomized clinical pilot study will compare the~     effects of two local treatments for preventing keloid recurrence after surgical removal;~     steroid and verapamil.~      Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal~     treatment efficacy as steroid injection.~   "
102149|NCT01720043|"~     To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours~     after infusion in patients with multiple myeloma~   "
102150|NCT01720030|"~     We hypothesise that levosimendan will have a positive influence on renal function during~     acute kidney injury in adult intensive care patients.~   "
102151|NCT01720017|"~     The overall purpose of this study is to assess the impact of preclinical airway manikin~     training using the Airtraq Avant and Wireless Monitor System under simulated difficult~     airway conditions (c-collar and swollen tongue) on the clinical learning curve of using the~     device/system in airways with predictors for difficult intubation.~      The investigators hypothesize that the clinical learning curve in airways with predictors~     for difficult intubation will be shorter for study subjects (operators) who undergo~     preclinical manikin training under simulated difficult airway conditions compared to Study~     subjects (operators) who do not receive this training. The clinical learning curve is~     characterized by procedure times and first attempt success rates on successive uses of the~     Airtraq Avant and Wireless Monitor System in patients with at least one predictor for~     difficult intubation.~   "
102152|NCT01720004|"~     The investigators designed a pilot randomized controlled trial to assess the feasibility and~     acceptability of repeated hands-and-knees positioning during labour. The objectives were 1)~     to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol~     by participants and care providers, 3) to obtain women's views about their experiences using~     the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the~     sample size calculation for a large trial.~   "
102153|NCT01719991|"~     The purpose of this study is to implement a pragmatic intervention in four (4) family~     medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients~     with chronic diseases.~   "
102298|NCT01718080|"~     Our goal is to investigate how hormones that control blood sugar, hunger, and stomach~     emptying change with puberty and being overweight. These substances change with a meal.~        -  For this, we need to compare lean and overweight children.~        -  We need to study them before and during puberty.~        -  All children in the study will be tested before and after a liquid meal.~   "
102154|NCT01719978|"~     Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used~     as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical~     efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more~     dangerous LA, especially in patients with increased cardiovascular risk. There is scarce~     clinical data about the safety of the use of hyaluronidase in dental procedures.~      This study aimed to compare hemodynamic and electrocardiographic variables during a dental~     surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in~     healthy subjects.~   "
102155|NCT01719965|"~     A popular form of community engagement is for the researchers to interact with a Community~     Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border~     for many years and has been informally engaging with the community for its healthcare and~     research initiatives, especially in the area of ethics and consent. In January 2009,~     community engagement was formalised with the establishment of the Tak Province Border~     Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the~     investigators have not come across any set up of similar nature involving mobile and~     unstable populations residing along a porous border.~      Three years on, SMRU questions if the T-CAB has been successful and if the current T-CAB~     model is the best model for this community. In order to evaluate the T-CAB, first an~     evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,~     then the evaluation will be carried out.~   "
102156|NCT01719952|"~     A double-blinded randomised control trial conducted in the Department of Obstetrics and~     Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC)~     for two years duration from January 1st, 2012 till December 31st, 2013.~      The aim of the study is to compare the haemodynamic and cardiovascular effects between~     intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective~     Lower Segment Caesarean Section (EL LSCS).~      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly~     safe and has similar efficacy in comparison to a single injection of oxytocin.~   "
102157|NCT01719926|"~     Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are~     recruited to the stroma of both the primary tumor and metastasis. Recent preclinical~     research has shown that in response to platinum-based chemotherapy, MSCs secrete two~     specific platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of~     chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and~     the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the~     COX-1 pathway. COX inhibitors, including indomethacin. This phase 1 study explores the~     safety of combining indomethacin with platinum containing chemotherapy.~   "
102158|NCT01719913|"~     Objective: To identify how specific changes of the gluten content in the diet affect the~     host-gut microbiome interactions with implications for metabolic health.~      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting~     of two 8-week interventions periods, separated by a 6-week wash-out period. A total number~     of 60 participants will be included.~      Intervention: low vs high gluten intake.~   "
102159|NCT01719900|"~     The recent dramatic increase in obesity has been linked to a reduction of dietary fibre~     intake. We hypothesized that supplementing the diet of overweight and obesity adults with~     pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.~     Other metabolic health improvements may include improved glucose control and reduced~     inflammatory markers.~   "
102160|NCT01719887|"~     Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures.~     These fractures have historically been treated mainly conservatively with good results.~     Recent development in fracture treatment and findings that certain fracture types are more~     prone to non-union and bracing-related functional problems of adjacent joints are somewhat~     common have caused increasing interest in treating these fractures surgically. Return to~     activities is also considered to be quicker among surgically treated patients.~      The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical~     treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who~     are willing to participate in the study after informed consent are randomly assigned to two~     different treatment methods:~        1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking~          plate.~        2. Conservative treatment with functional bracing~      The randomization is done using blocked randomization (block sizes are not known by the~     enrolling or assigning phycisian) and stratification is done according to fracture type~     (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no~     palsy).~      Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up~     visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation~     forms and clinical and radiological assessments are made. The physiotherapist doing~     objective functional measurements is blinded to treatment method. Both study groups receive~     physiotherapy after the initial treatment.~   "
102161|NCT01719874|"~     The purpose of this study is to determine the safety and efficacy of TCN-032 given to~     healthy adult volunteers that have been inoculated with the influenza A virus~   "
102162|NCT01719861|"~     Intrapatient dose escalation of desipramine. Start at 75 mg daily. Increase by 75 mg weekly~     to maximum of 450 mg daily. Taper desipramine upon disease progression, unacceptable~     toxicity or patient withdrawal from study.~   "
102163|NCT01719848|"~     Failure of advanced airway security has been reported that it could lead lethal complication~     such as brain hypoxic damage. There have been controversial reports for the airway~     assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated~     diagnostic validity of pre-existing airway assessment tests and scoring system using a gray~     zone approach in patients undergoing general anesthesia required endotracheal intubation.~   "
102164|NCT01719835|"~     This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental~     arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will~     be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.~   "
102315|NCT01717859|"~     The purpose of this research study is to determine if a change in inflammation or baseline~     inflammation seen on the ultrasound is a good indicator of how rheumatoid arthritis patients~     respond to TCZ 4mg/kg and whether early prediction of dose escalation is possible by~     utilizing ultrasound inflammatory measures.~   "
102165|NCT01719822|"~     Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD),~     who perform regular physical activity, have improved health and wellbeing compared with~     those who do little exercise. The purpose of the study is to evaluate whether the use of a~     simple pedometer (step counter) to set targets for daily physical activity can encourage~     COPD patients referred for an 8-week pulmonary exercise based programme (PR) to be more~     active. The investigators also want to know whether the use of pedometers during PR can~     improve adherence, self-management and outcome in COPD.~   "
102166|NCT01719809|"~     This is a prospective, observational, single-center study. Patients with at least 3 months~     of experience using topical medications for glaucoma and who state that they administer~     their own eye drops will be recruited. Subjects will be videotaped instilling a sterile~     artificial eye drop, will be identified at the time of a regularly scheduled exam. If the~     patient can get a drop onto the eye and also not touch their lids or ocular surface with the~     eye drop bottle, the subject will be thanked but not enrolled. All other patients who agree~     to participate will be enrolled. Upon completion of videotaped instillation of an eye drop,~     each enrolled patient will be shown a video demonstrating an instillation technique and will~     be given an instructional handout highlighting a proper drop instillation technique. If~     necessary, an instillation technique will be demonstrated to them by an investigator or~     trained personnel.~      A patient will be identified as properly instilling a drop if they satisfy the following~     criteia:~      They are able to instill one (and only one) drop to the ocular surface or lower fornix~     without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.~      All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the~     investigator or trained personnel would direct the patient to instill an eye drop into the~     study eye.Additionally, the short glaucoma self-efficacy questionnaire will be~     re-administered.~      All of the video-recordings of participants' eye drop instillation techniques will be~     reviewed and assessed using a standard checklist. Their ability to administer an eye drop~     after training will be compared to baseline.~   "
102167|NCT01719796|"~     Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment.~     Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The~     investigators hypothesized bilateral continuous transverse abdominal plan block would reduce~     ventilatory impairment following abdominal surgery.~   "
102168|NCT01719783|"~     To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133~     (H5N2) in healthy adults.~   "
102169|NCT01719770|"~     Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers~     are in use, together with analgesia and sedation, during the cooling process in many centers~     to prevent shivering. Since neuromuscular blockers are accused to be associated with various~     side effects causing serious harm and/or leading to prolong ICU stay. So economical use~     seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic~     activity. Therefore, post hypoxic seizures might remain undetected.~      Aim of this study is to investigate if a continuous application of neuromuscular blockers is~     necessary to prevent shivering and thereby avoid the counter regulation to achieve the~     target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.~      A single center (university hospital) study. Randomized, double blinded, double dummy study~     design. Eligible are all adult patients after successful resuscitation due to cardiac arrest~     of presumed cardiac origin.~      All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed~     cardiopulmonary origin will be included.~      Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with~     known or clinically apparent pregnancy, patients who reach our hospital with a body~     temperature below 35°C, patients with known allergic reactions against rocuronium, patients~     with a history of myasthenia gravis, patients with obvious intoxication, wards of the~     state/prisoners and patients with known epileptic disease will be excluded.~      Primary outcome:~      Shivering episodes will be scored with the Shivering Assessment Scale.~      Secondary outcome:~      Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and~     total energy needed during the cooling period will be compared between the two groups.~      Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum~     levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.~      Train-of-four will be performed to assess the depth of relaxation. Sedation will be~     monitored via bispectral index; measurement of metabolic activity will be evaluated using~     indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities.~     Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.~   "
102170|NCT01719757|"~     The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to~     Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under~     conditions of daily practice.~   "
102171|NCT01719744|"~     This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue~     sarcoma. This study will help to understand how well ENMD-2076 works and how safe and~     tolerable the drug is in this patient population.~   "
102172|NCT01719731|"~     Recent research suggests that BPD is a common, serious but treatable disorder with a better~     than previously recognized prognosis. Despite these findings, many patients with BPD are not~     given the borderline diagnosis by the mental health professionals treating them. It is also~     true that many newly diagnosed borderline patients are not provided with up-to-date~     information on the disorder even though psychoeducation has been found to be a useful form~     of treatment for other serious psychiatric illnesses.~      The investigators have conducted a preliminary randomized trial of psychoeducation for BPD~     that found that those provided with immediate psychoeducation had a significantly greater~     reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than~     those with delayed psychoeducation.~      However, both instruction and assessment of change over time were conducted in person by~     paraprofessionals. The importance of the current study is that it will allow the~     investigators to develop and test the efficacy of an internet-based program of~     psychoeducation for BPD that will be both cost efficient and easy to disseminate widely,~     particularly to underserved populations.~   "
102173|NCT01719718|"~     A multicenter prospective randomized controlled trial comparing closure versus non-closure~     of the hernia defect between 2 and 5 cm in width using a tissue separating mesh~     (Physiomesh™) in laparoscopic ventral hernia repair.~   "
102195|NCT01719432|"~     Studies have shown that different percentages of body fat can alter the way drugs are~     distributed in the body. This study will use blood samples taken at different time points~     for patients taking Neupogen to determine if higher body weights affect drug exposure. The~     information gathered from this study will help understand if patients with higher body~     weights need a different dosing plan.~      Patients in this study will have blood draws once before they take Neupogen and 6 times~     after they take the Neuopen (for a total of 24 hours). These patients will be in the~     hospital already and will not need to make additional trips back to have blood drawn. A~     total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and~     15 matched, non-obese patients will be enrolled into this study.~   "
102196|NCT01719419|"~     The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the~     taste for fat in humans.~   "
102174|NCT01719705|"~     Post-cesarean pain management is essential for early mobilization of the mother so that she~     becomes able to care of her newborn. There choices for postoperative analgesia include~     spinal, systemic, or both opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local~     anesthetic infiltrations of the wound, or transverse abdominis plane blocks, which are~     determined by drug availability, regional and individual preferences, resource limitations~     and financial considerations. The use of opioids is associated with adverse effects such as~     nausea, pruritus, sedation, and occasionally respiratory depression.~      Pregabalin is an anticonvulsant drug structurally related to the inhibitory neurotransmitter~     gamma amino butyric acid, that exerts its action by binding to the α-2-δ subunit of the~     voltage-dependent calcium channel. It reduces the release of the excitatory~     neurotransmitters and inhibits the hyperalgesia and central sensitization.~      A recent meta-analysis demonstrated that pregabalin reduce the postoperative 24 hours~     cumulative opioid consumption and opioid-related adverse effects namely, vomiting and visual~     disturbances after surgery. Compared with the use of pregabalin doses lower than 300 mg, the~     use of doses higher than 300 mg even reduced opioid consumption by 35%.~      It is not known if pregabalin is excreted in human milk. There is a case report on the~     extensive excretion of pregabalin in breast milk, but with low measured concentrations in~     infant as a consequence of maternal exposure during breast feeding. Food and Drug~     Administration recommends to discontinue nursing or to discontinue pregabalin in nursing~     mothers. Pre-delivery single exposure to pregabalin is expected to be safe for the newborns.~      Up to the authors' best knowledge, this is the first clinical study on the efficacy and~     safety of the administration of pregabalin before cesarean delivery.~      We hypothesis that the preoperative administration of a single dose of pregabalin will~     improve the quality of postoperative analgesia after cesarean delivery.~      This placebo-controlled study aims to compare the effects of preoperative administrations of~     single oral doses of pregabalin 150 mg and 300 mg on the postoperative pain scores,~     cumulative patient controlled morphine consumptions, neonatal Apgar and neurologic and~     adaptive capacity scores (NACS), and maternal and neonatal adverse effects in parturients~     scheduled to elective Cesarean delivery under spinal anesthesia.~   "
102175|NCT01719692|"~     A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows~     low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this~     study is to compare the efficacy and tolerability of two different regimens of low doses~     rituximab for the treatment of adult patients with ITP.~   "
102176|NCT01719679|"~     The provision of adolescent vaccination in a school setting will be feasible and acceptable~     to parents as evidenced by the number and percentage of students immunized within each~     school compared to those in schools without a program. The likelihood of vaccination for~     diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal~     conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools~     with a comprehensive school-based immunization program will be significantly higher than~     that of students enrolled in schools without a school-based immunization program.~   "
102177|NCT01719666|"~     The investigators hypothesis is lateral retinaculum release has no effect on treatment of~     Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.~   "
102178|NCT01719653|"~     The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and~     SUPREP to see which preparation cleanses the colon best and which preparation is best~     tolerated.~   "
102179|NCT01719640|"~     Central nervous system (CNS) injury leads to morbidity in patients, which has few good~     rehabilitation measures. Mesenchymal stem cells seem to have regenerative and~     tissue-repairing capabilities. The investigators design this study to infuse mesenchymal~     stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy~     by recording the change of nervous system scores, trying to prove the effect of MSC in~     rehabilitate CNS injury.~   "
102180|NCT01719627|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will assess the~     potential of MVC as a on demand pre-exposure prophylaxis, within a strategy for the~     prevention of HIV infection in men who have sex with men (MSM).~   "
102181|NCT01719614|"~     The purpose of the study is to evaluate the effect of steady-state (constant concentration~     of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin~     is absorbed in the body, distributed within the body, and removed from the body) of a single~     dose of metformin, over time, in healthy adult participants.~   "
102182|NCT01719601|"~     The purpose of this study is to evaluate the safety and effectiveness of immediate release~     tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among~     Filipino patients.~   "
102183|NCT01719588|"~     The purpose of this study is to evaluate the safety and effectiveness of prolonged release~     tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among~     Filipino patients.~   "
102184|NCT01719575|"~     The purpose of this study is to compare the effects of Motilitone and placebo on gastric~     volumes, gastric emptying, small bowel transit and colon transit in female and male healthy~     volunteers.~   "
102185|NCT01719562|"~     This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage~     in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help~     doctors predict whether patients will have heart damage caused by chemotherapy in patients~     with cancer receiving chemotherapy.~   "
102186|NCT01719549|"~     This is a single-center, prospective, single-arm, open-label phase II study~   "
102187|NCT01719536|"~     The purpose of this study is to compare icotinib with induction and maintenance chemotherapy~     in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with~     EGFR mutation.~   "
102188|NCT01719523|"~     The purpose of this study is to examine the effects of EPI-743 on tic severity in adults~     with Tourette syndrome.~   "
102189|NCT01719510|"~     The main objective of this study : Demonstrate that GBS (group B streptococci) ST-17~     colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS~     non-ST-17.~      Secondary objectives:Determine:~        -  The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant~          women.~        -  The frequency of colonization of neonates by GBS ST-17 at birth.~        -  The preferential site of colonization in the mother (rectum, vagina, breast milk).~        -  The kinetics of colonization after birth in the newborn.~        -  The sensitivity and specificity of different GBS detection methods (conventional~          phenotypic versus molecular) in the different types of samples from the mother and the~          newborn.~   "
102190|NCT01719497|"~     The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging~     agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics~     and binding characteristics.~   "
102191|NCT01719484|"~     To examine the influence of obesity on brain activation during food cue, stress, and neutral~     relaxing conditions~   "
102192|NCT01719471|"~     To examine the influence of current daily tobacco smoking on brain activation during stress,~     tobacco cue, and neutral relaxing conditions~   "
102197|NCT01719406|"~     Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a~     condition that can adversely affect the pregnant woman, her developing fetus and future~     events for both. To reduce GDM risk, we will develop and implement an in-person team and~     web-based nutrition and exercise program for women, beginning in their first trimester. A~     scripted, peer-led, 20-week educational program, tailored for pregnant women working in~     teams (5 women/team), will be developed and implemented among pregnant employees and/or~     their spouses. Each weekly thirty minute session will focus on achieving 30-minutes of~     moderate daily physical activity with nutrition targets of five servings of fruits and~     vegetables, 3 servings of whole grains and lower fat food choices. Diet, exercise and lab~     assessments will occur before enrollment during the first trimester, each subsequent~     trimester and 12 weeks after delivery. In addition to exercise and diet survey results, we~     will assess fasting glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood~     pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each~     trimester and at 12 weeks post delivery, as well as gestational birth age, Apgar score,~     delivery mode and infant birth weight, and weekly health thermometer self-ratings during the~     assessment period.~   "
102198|NCT01719393|"~     Our hypothesis is that radial arterial pulse may reflect the severity and airway function in~     asthmatics. The aims of this study are to investigate the pulse spectrim of the radial~     artery in adult asthmatics, and evaluate its correlation with airy inflammation an lung~     funtion in asthmatics.~   "
102199|NCT01719380|"~     This study will assess the safety and efficacy of LGX818 when combined with cetuximab or~     combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer~   "
102200|NCT01719367|"~     Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming~     increasingly prevalent in the Western world. The number of people with AF in the United~     States is projected to roughly double by the year 2050, to an estimated 6-12 million. For~     many patients with AF, rate control with atrioventricular (AV) node blockers is a widely~     accepted therapeutic strategy. These agents control heart rate, thus preventing symptoms and~     systolic heart failure associated with tachycardia due to a rapid ventricular response to~     AF. Beta-blockers are widely accepted as first line agents for rate control in AF,~     especially when patients have concomitant hypertension (HTN), coronary artery disease,~     cardiomyopathies, or heart failure (HF). As a class, beta-blockers are among the most~     commonly prescribed cardiovascular medications.~      Among patients with AF treated with beta-blockers, the heart rate (HR) response varies~     substantially. Sometimes, adequate rate control can be achieved by titration of the~     beta-blocker dose; but frequently, additional AV nodal blockers and/or digoxin are~     necessary. In some cases, adequate rate control cannot be achieved even with the~     simultaneous use of multiple AV nodal blockers, necessitating mechanical ablation of the AV~     node and permanent pacemaker implantation.~      Patient-specific variables that influence the response to beta-blockers include comorbid~     conditions, weight, age, and level of physical activity. Ethnic differences in the response~     to beta-blockers for the treatment of HTN and HF are well-described. However, the~     contribution of genetic variants to beta-blocker efficacy in AF is unknown. We propose to~     study, using a candidate gene approach, the effect of genetic variants on heart rate~     response to beta-blockade in patients with AF.~   "
102201|NCT01719354|"~     This is a trial to examine the effects of aftercare for mental health patients in community~     health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric~     hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two~     groups: intervention group (community health center, primary care) or control group~     (Community mental health centers of District Psychiatric Service, specialist care).~      The project's primary objective is to investigate the effect of community services on~     patients' functional capacity and user satisfaction after discharge. Secondly, the number of~     treatment days and readmissions to mental health care will be examined. The project will~     also compare costs of hospitalization, in psychiatric hospital and community health center~     respectively. Data will be collected from community health records, medical records and~     patient systems in psychiatric hospital, community mental health centers of District~     Psychiatric Service (DPS) and questionnaires filled out by patients.~   "
102202|NCT01719341|"~     Allogeneic haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy~     for patients with both haematological and some non-haematological disorders. However, one of~     the major limiting factors for transplantation is the inability to identify a suitable~     HLA-matched donor. Development of an cost-effective and clinically efficacious alternative~     to HLA-identical sibling or unrelated donor transplantation would significantly expand the~     availability of allogeneic HSCT to patients in Singapore. Preliminary results indicate that~     the use of high dose post-transplant cyclophosphamide (Cy) for graft versus host disease~     (GVHD) prophylaxis in haplo-identical allogeneic HSCT is associated a low incidence of GVHD~     and low treatment related toxicity. We propose a phase II clinical trial to assess the~     efficacy of a haplo-identical allogeneic transplantation protocol using high dose~     post-transplant Cy for the treatment of patients with haematological disorders. A~     non-myeloablative protocol (Fludarabine-low dose cyclophosphamide-TBI) will be used for~     patients with bone marrow failure syndromes and indolent lymphoid disease. In view of the~     higher relapse risk of patients with myeloid malignancies, these patients will be treated~     with a reduced intensity conditioning regimen (Fludarabine-Busulphan). The primary end-point~     of the study will be overall survival at one year. Economic cost of the haplo-identical~     transplantation, as well as treatment timelines will be recorded and compared will other~     forms of unrelated donor allogeneic transplantation (umbilical cord blood transplantation~     and unrelated HLA-matched adult donor). Immunological reconstitution of patients following~     haplo-transplantation will be analysed and data will be utilized to guide future~     immunotherapy strategies post-transplantation.~      One year survival after non-myeloablative haploidentical stem cell transplantation is not~     inferior to that observed after non-myeloablative volunteer unrelated donor or unrelated~     cord blood haematopoietic stem cell transplantation.~   "
102203|NCT01719328|"~     The purpose of this study is to examine the immediate and cumulative effects of yoga on~     stress and mood among young adult college students attending an 8-week program in Vinyasa~     yoga.~   "
102204|NCT01719315|"~     The goal of this project is to examine the neurophysiology of hypersomnia during sleep and~     wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,~     and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to~     determine if this decreases daytime sleepiness in these patients. The primary study~     hypotheses are that individuals with hypersomnolence will have reduced slow wave activity~     (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain~     regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent~     patients will increase SWA during sleep, reduce theta/alpha activity during wake, and~     improve subjective sleepiness.~   "
102316|NCT01717846|"~     This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related~     genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.~   "
102205|NCT01719302|"~     Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients~     with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine~     kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.~      The Phase I component of this study is designed to determine the maximum tolerated dose of~     pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to~     determine the overall response rate of the combination of docetaxel, gemcitabine and~     pazopanib prior to surgical resection in patients with soft tissue sarcoma.~   "
102206|NCT01719289|"~     Background: depression during pregnancy is an important problem for public health. It has~     direct consequences for the affected woman, her children and family, and is a strong~     predictor of post-partum depression. In developing countries depression during pregnancy is~     highly common, and usually unrecognized and untreated.~      Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by~     nurse assistants in the management of pregnant women with depression in primary care clinics~     that adopt the Family Health Strategy in Sao Paulo, Brazil.~      Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with~     depression attending pre-natal care in 12 Primary Care Units with Family Health Program,~     covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a~     stepped-care approach and is delivered by health professionals working at the primary care~     unit responsible by the care of the women. All women from the intervention group receive a~     program based on psycho-education and problem solving techniques, delivered by a nurse~     assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2~     after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the~     beginning of the sessions. Women with severe depression are referred to the family doctor~     and are assessed for the need of antidepressant medication. The control group receives~     routine care. The primary outcome is remission of depressive symptoms 4-months after the~     inclusion in the study. Secondary outcomes include remission of depressive symptoms at 6~     months after delivery. Women are also assessed for socioeconomic and household~     characteristics, social support and obstetric complications. The effectiveness and~     cost-effectiveness of the intervention will be assessed with intention-to-treat analysis,~     using the clinical outcome and the assessment of quality of life (EQ-5D) four months after~     inclusion in the trial.~   "
102207|NCT01719276|"~     The purpose of this study is to compare the efficacy of graded activity program and~     supervised exercise on pain, functional disability, quality of life, global perceived~     effect, return to work, physical activity, physical capacity and strength of the lower limbs~     in patients with chronic non-specific low back pain~   "
102208|NCT01719263|"~     This study is designed to demonstrate safety and efficacy in patients with severe upper lobe~     predominant emphysema. For validity of the study, the results will be compared to patients~     that receive optimal medical therapy.~   "
102209|NCT01719250|"~     This pilot clinical trial studies how well buparlisib works in treating patients with~     non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to~     previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
102210|NCT01719237|"~     A double blinded randomized controlled trial comparing the onset and duration of the Onset~     and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local~     anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic~     (Ropivacaine-Chloroprocaine Mixture).~   "
102211|NCT01719224|"~     The investigators hypothesized that sleeping in a 45 degrees elevated body position~     decreases the likelihood of upper airway vulnerability to collapse. Furthermore, the~     investigators want to elucidate the anatomical and physiological risk factors that~     contribute in the upper airway obstruction in post-partum patients.~   "
102212|NCT01719211|"~     The investigators have successfully identified two novel genetic loci for MVP on chromosomes~     11 and 13 and are searching for altered genes in these regions. This requires recruiting~     large families who may have MVP linked to these or other chromosomes; and obtaining DNA~     samples from 1,000-1,500 individually affected patients to study the relation between DNA~     markers throughout the genome and MVP. It is our expectation that the results of this study~     will lead to the discovery of gene(s) responsible for MVP. This will lead to improved~     understanding of the disease and, in turn, improved ability to treat and prevent progression~     in genetically susceptible individuals.~   "
102213|NCT01719198|"~     The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the~     assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin~     level, which could mean the role of fecal calprotectin as a screening marker for colon~     adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker~     for screening in this study.~   "
102214|NCT01719185|"~     This is a pilot study designed to test the hypothesis that the combination of phentermine~     and B12 will result in significantly greater weight loss among obese patients compared to~     phentermine alone.~   "
102215|NCT01719172|"~     The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when~     used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would~     be used.~   "
102216|NCT01719159|"~     This is a is a small scale open phase two interventional study to assess long-term~     stabilising effects of on neurological symptoms by regular intrathecal administered~     monoclonal antibodies in progressive multiple sclerosis.~   "
102217|NCT01719146|"~     The purpose of this study is to prospectively collect data on doses of Erythropoietic~     Stimulating Agents and Intravenous Iron, and the markers of erythropoietic activity and iron~     status. These data will be used to derive mathematical models which will subsequently guide~     dosing of both agents, such that a desired therapeutic outcome is achieved in every patient,~     while minimizing patient exposure to both agents.~   "
102218|NCT01719133|"~     Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the~     major birch allergen bet v 1, in subjects allergic to birch pollen.~   "
102219|NCT01719120|"~     The aim of this study is to develop an Internet-based self-help therapy program for insomnia~     in Chinese language, and to conduct a randomized waiting-list controlled trial on the~     efficacy of Internet-based self-help therapy for insomnia.~   "
102220|NCT01719107|"~     The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency~     and severity in children of 5-16 years old and with diagnosis of FAP.~   "
102233|NCT01718938|"~     This is a multicenter, randomized, double-blind, incomplete block, three period fixed~     sequence crossover, multicenter, placebo-controlled study. The study will assess three oral~     doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three~     periods of 1-week duration each, with a 1-week washout period between treatment periods, in~     subjects with diabetic or idiopathic gastroparesis.~      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic~     gastroparesis by assessing changes in gastric emptying.~   "
102221|NCT01719094|"~     Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,~     occurring at a significantly younger age than in the general population. The increased~     incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and~     mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,~     understanding of the mechanisms by which cancer treatment could influence the occurrence of~     latent cardiovascular events is unavailable. Our group and others have established~     independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in~     middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,~     cardiac death, and congestive heart failure. The goal of this application is to show that~     childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health~     have increased aortic stiffness, when compared to healthy adolescent and young adult age~     mate. Studies are designed to determine if MRI measures of cardiovascular function differ~     between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and~     adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25).~     The investigators propose that MRI markers responsible for cardiovascular events represent~     new clinical indicators that could be targeted to treat asymptomatic cardiovascular~     diseases.~   "
102222|NCT01719081|"~     This project involves the assessment of the efficacy of two different image guided~     techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).~     Intra-articular injection of local anesthetics and steroids is performed to relieve pain~     originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for~     this procedure but there is a growing interest in use of ultrasound (US) for this procedure.~     US avoids radiation exposure to the patient and the health care team (HCT) and is less~     expensive. We aim to compare procedural efficacy related outcomes for SIJ injections~     performed using these image-guided modalities.~   "
102223|NCT01719068|"~     This is a pilot study that aims to develop a lung cancer screening program for workers in~     British Columbia, Canada exposed to asbestos who are at risk of developing lung~     cancer/pleural mesothelioma. This is high risk population is at of respiratory system~     diseases as a result of their occupational exposures. Additionally, knowledge garnered from~     this study will allow us to develop other studies that will further our understanding of~     asbestos related lung cancer and mesothelioma.~   "
102224|NCT01719055|"~     To compile characteristics of real-world clinical outcomes for Boston Scientific~     commercially approved neurostimulation systems for pain in routine clinical practice, when~     used according to the applicable Directions for Use~      - and -~      To evaluate the economic value and technical performance of Boston Scientific commercially~     approved neurostimulation systems for pain in routine clinical practice~   "
102225|NCT01719042|"~     The purpose of this study is to improve tolerance of treatment of pulmonary Mycobacterium~     avium Complex disease via the use of therapeutic drug monitoring and the addition of~     anti-nausea medication or dietary supplements to the patients' daily drug regimen. The aims~     of this study are to use (1) Zofran® (Ondansetron 8mg), an anti-nausea medication or (2) a~     dietary supplement to decrease medication related gastrointestinal side effects of~     medications used to treat Mycobacterium avium Complex.~   "
102226|NCT01719029|"~     A better understanding of the optimal diet for women with gestational diabetes is~     fundamental to the management of this rapidly growing problem in pregnancy. Careful~     comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in~     complex carbohydrate but lower in fat is critical in order to determine which diet results~     in a more favorable maternal 24-hour glucose, lipid, and inflammatory profile, all of which~     directly effect optimal fetal growth and may influence the future health of the offspring.~   "
102227|NCT01719016|"~     Diagnosis of relative contributions of large artery blockages and microvascular blockages is~     very much needed in the treatment of coronary artery disease. In order to achieve this, two~     novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings~     and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with~     pressure and flow readings, are being investigated.~   "
102228|NCT01719003|"~     This study will investigate the efficacy and safety of two doses (high and low) of~     empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in~     patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of~     empagliflozin + metformin versus each individual component after 24 weeks of treatment.~   "
102229|NCT01718990|"~     Drug discovery can take many years especially since most studies to measure effectiveness~     depend on clinical outcomes like pulmonary function tests and hospitalizations.~      This is an observational study designed to collect information, blood, and bronchoalveolar~     lavage fluid in people who have IPF and those who do not. The people who have IPF will be~     followed for 12 months to collect more biological samples and record clinically relevant~     information.~      The goal of this study is to identify new molecular markers that are measurable and reliable~     in people who have IPF. It is hoped that these markers can be used in future drug studies to~     significantly speed up the process of finding drugs that help.~   "
102230|NCT01718977|"~     This study aims to determine whether body weight-supported treadmill training (BWSTT) has~     beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of~     cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).~      After SCI, the primary cause of illness and death is CVD. Currently, preventative measures~     focus around increasing physical activity- especially through the use of ACET. However,~     ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated~     that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular~     health in individuals with SCI.~      The studies primary outcome measure is aortic pulse wave velocity (aPWV) which has been~     shown to have prognostic value for CVD above and beyond that of other risk factors. It is~     hypothesised that through large muscle mass involvement and postural challenge, the physical~     stimuli of BWSTT will reduce aPWV and lower CVD risk in individuals with SCI.~   "
102231|NCT01718964|"~     To investigate the effects of cortisol on heroin craving and stress reaction in heroin~     addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single~     administration of study medication Study hypothesis:Cortisol has an inhibiting effect on~     heroin craving and stress reactivity in opioid dependent subjects.~   "
102232|NCT01718951|"~     To compare the efficacy of golimumab with pamidronate in the treatment of axial~     spondyloarthropathy~   "
102234|NCT01718925|"~     The burden of chronic disease is continuing to rise. Even though patients may be in~     remission or have quiescent disease, several studies have confirmed that symptoms, such as~     e.g., fatigue, is troublesome.~      The primary aim of this study is to investigate whether or not there might be an association~     between levels of vitamin D and the subjective experience of fatigue in conditions, such as~     inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel~     syndrome.~      Secondary aims is to study both the co-occurence and influence of pain, depression and~     anxiety.~   "
102235|NCT01718912|"~     Many physically handicapped patients at the dental department, Toronto Rehabilitation~     Institute(TRI) have considerable gingival inflammation and breath odour because of the~     inability to effectively handle a toothbrush. These patients have considerable periodontal~     disease. There is a concern that these pathogens may have a detrimental effect on wound~     healing in other areas of the body.~      Hypothesis: Patients attending the dental department at TRI that are treated with the~     antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial~     decrease in periodontal disease as measured by bleeding points and pocket depth when~     compared to the group that continues to use their regular oral hygiene methods (control~     group).~   "
102236|NCT01718899|"~     The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer~     vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent~     and in combination with lenalidomide.~   "
102237|NCT01718886|"~     The objective of this study is to evaluate the initial safety and preliminary effectiveness~     of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27~     - 35 kg/m^2~   "
102238|NCT01718873|"~     The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy~     compared to giving bevacizumab at the same time as chemotherapy improves patient overall~     response to treatment.~   "
102239|NCT01718860|"~     The investigators evaluate the assumption that postoperative residual curarization is~     associated with impaired gas exchange upon post anesthesia care unit arrival and longer~     hospital length of stay. Additionally, the investigators also evaluate the assumption the~     use of neostigmine reversal of residual neuromuscular block is associated with an increased~     incidence of postoperative pulmonary complications and intensive care unit admission.~   "
102240|NCT01718847|"~     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the~     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line~     monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR~     tyrosine kinase inhibitors (TKIs).~   "
102241|NCT01718834|"~     Description: A randomized Placebo-controlled study to evaluate safety and efficacy of Cenv3~     peptide vaccine in normal volunteers. This study is designed to test safety of 3 consecutive~     monthly escalating doses of the immunogen ( 0.324 mg, 0.648 and 3.240 mg / 70 kgm body~     weight) in 40 healthy male subjects (15,15 and10 subjects respectively) plus 10 subjects on~     placebo. Bioavailability of Cenv3 will be tested throughout the duration of the experiment.~     In the study hyperimmune state will be achieved via 3 subcutaneous injections (0.648 mg~     each), once every 4 weeks. A placebo treated healthy subjects ( n= 10) will serve as~     controls. Chronic HCV patients ( n=50) who did not respond to IFN + RBV combined therapy~     will be recruited to test therapeutic efficacy of the compound via 6 consecutive injections~     ( 0.648 mg each ) every 2 weeks. ( NB : this group of patients has been already recruited in~     the first part of this project where evaluation of the compound is currently underway).~     Immunized healthy volunteers will be followed for a year compared with placebo group, where~     all biochemical, hematological, immunological and allergic parameters are recorded. Treated~     CHC patients will be evaluated for virological, hematological, biochemical and immunological~     states at the end of treatment.~      Subject : Cenv3 potential prophylactic and therapeutic immunogens in healthy volunteers and~     against chronic HCV infection respectively.~   "
102242|NCT01718821|"~     Pain is one of the most common symptoms associated with cancer. The approach to pain~     management compresses routine pain assessments, utilizes both pharmacologic and~     nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer~     pain can be well controlled in the vast majority of patients if the algorithms of pain~     control are systematically applied, carefully monitored, and tailored to the needs of the~     individual patient.This study is aimed to assess the current pain managements in upper~     gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression~     on the enrolled patients would also be assessed.~   "
102243|NCT01718808|"~     OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront~     cetuximab treatment delivered as monotherapy or as part of a combination treatment with~     capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral~     oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic~     colorectal cancer (mCRC).~   "
102244|NCT01718795|"~     During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.~     Ventilation may be inefficient or with too high pressures result in stomach inflation and~     aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal~     tube, a basically skilled rescuer may ventilate more efficient and also safer. No~     prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation~     during CPR. Thus, this study intends to compare ventilation with laryngeal tube and~     bag-valve mask performed by paramedics during CPR.~   "
102245|NCT01718782|"~     The purpose of this study is determine safety and efficiency of mechanical ventilation in~     children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA~     Supreme). The main interest is leakage pressure of oropharynx and stomach. The null~     hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The~     alternative hypothesis is that there is a difference in leakage pressure.~   "
102279|NCT01718327|"~     For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is~     considered as the reference treatment in first line chemotherapy. However, the outcomes of~     these patients remain limited and therefore more effective drugs are warranted. The context~     of the disease and current data on sunitinib suggest that sunitinib may have activity in~     patients with advanced non resectable cholangiocarcinoma.~      Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity~     of sunitinib in such a patient population.~   "
102246|NCT01718769|"~     Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to~     weight loss or insufficient weight gain, is related to an increase in morbidity and~     mortality and exposes the child to medical complications. In addition, obesity is also~     related to complications during hospitalization and complications in general, and therefore~     early identification of these children is extremely important. Studies show that~     malnutrition is frequent among children upon hospitalization, where the risk of pediatric~     nutritional deterioration increases, even in the presence of mild stress factors. This risk~     is frequent mainly among children that arrive at the hospital with an initial poor~     nutritional status. Improving the nutritional status as part of the standard of care already~     at the ambulatory setting might improve the prognosis of children when ill. In Israel,~     nutritional screening in not conducted among children since there is no proper validated~     screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for~     pediatric nutritional risk which is designed to be used by nurses, and to compare it to a~     complete nutritional assessment conducted by a dietician in Clalit Health Care Services~     clinics. In addition, the investigators wish to examine the effects of using a screening~     tool for nutritional risk on the medical staff's attention to the nutritional status; this~     is measured by the collection of nutritional status-related data and their recording in the~     patient file.~      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric~     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3~     questions with a summary score, according to which the nutritional risk level shall be~     determined. These children shall also undergo a complete dietician assessment in order to~     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the~     beginning of the research and after 6 months in order to estimate the change in medical~     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to~     nutritional status- related tests and recording of anthropometric measurements.~      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using~     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi~     square test.~   "
102247|NCT01718756|"~     Perioperative continuous infusion of lornoxicam would be an effective and safe regimen to~     reduce the patient controlled morphine consumption after orthopaedic surgery.~      After ethical approval, 96 patients scheduled for elective orthopaedic fracture surgery~     under general anaesthesia were randomly allocated to receive placebo, 12-hourly iv~     lornoxicam 16 mg or lornoxicam 16 mg followed with continuous infusion of 1.3 mg/hr., for 48~     hours after surgery (n=32 per group). Anaesthesia was induced with propofol, sufentanil and~     rocuronium, and was maintained with 0.5-1 minimum alveolar concentration sevoflurane,~     sufentanil and rocuronium. Postoperative patient controlled morphine analgesia was used.~     Changes in heart rate, mean blood pressure and sevoflurane minimum alveolar concentration,~     visual analogue pain scores, and cumulative patient controlled morphine consumptions and~     blood loss for 48 hours, platelet functions, bone non-union and the presence of adverse~     effects were recorded.~   "
102248|NCT01718743|"~     The goal of this clinical research study is to learn if the combination of MLN9708 and~     Revlimid (also called lenalidomide or CC-5013) can help to control MM as maintenance~     treatment after an autologous stem cell transplant.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease or~     prevent the growth of cancer cells.~      MLN9708 is designed to block a protein that plays a role in cell function and growth. This~     may cause cancer cells to die.~   "
102249|NCT01718730|"~     The purpose of this study is to learn if measures of brain activity are different in~     children and adolescents with depression who are in different stages of treatment. This is~     important because it may identify a biological marker for depression that could one day be~     used to identify depressed children who would benefit from certain treatments (medications~     for example), or to monitor how well treatments are working. Brain activity measures(known~     as cortical excitability and inhibition) will be collected by Transcranial Magnetic~     Stimulation (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation~     technology which can make parts of the brain work without putting any wires or chemicals~     into the body. Measurements will take place over one 3-hour visit. This study does not~     provide any form of treatment.~      *There is an optional portion of the study that uses a brain scan to gather measures of~     brain structure and brain chemicals. The brain scan is called magnetic resonance and~     spectroscopy (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and~     brain chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.~   "
102250|NCT01718717|"~     Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce~     the occurrence of AF if it is continued for six postoperative days instead of just three.~   "
102251|NCT01718704|"~     The purpose of this study is to evaluate whether using penile vibratory stimulation with the~     Viberect handheld device can help the recovery of erections and urinary control after~     radical prostatectomy.~   "
102252|NCT01718691|"~     The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day~     consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip~     infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma~     where hematopoietic stem cell transplantation is not indicated.~   "
102253|NCT01718678|"~     The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment~     of fatigue and Quality of Life of MS patients.~   "
102254|NCT01718652|"~     The purpose of this study is to determine how a single dose of cyclosporin affects the~     pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin~     (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in~     healthy volunteers.~   "
102255|NCT01718639|"~     This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical~     trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in~     postprandial heartburn.~      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in~     terms of efficacy for postprandial heartburn treatment.~   "
102256|NCT01718626|"~     Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to~     concomitant S1+Docetaxel in the safety and clinical efficiency.~      Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance~     treatment for advanced gastric cancer.~   "
102257|NCT01718613|"~     Although arginine vasopressin has been used as an additional drug in refractory shock in~     worldwide clinical practice, there are no prospective studies using it as a first choice~     therapy in patients with cancer and septic shock.~      The aim of this study is assess if the use of arginine vasopressin would be more effective~     on treatment of septic shock in cancer patients than norepinephrine, decreasing the~     composite end point of mortality and organ failure in 28 days.~   "
102280|NCT01718314|"~     Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it~     enables the doctor to do minor operative procedures. Although it causes little discomfort,~     sometimes it may be disturbing for the patient. This pain is usually perceived during the~     passage of the instrument through the cervix (neck of the womb). The investigators would~     like to minimize this pain by two drugs: Misoprotol and lidocaine~   "
102258|NCT01718600|"~     Microembolization is commonly associated with carotid artery stenting (CAS), but our~     understanding of subclinical microembolization is superficial. Through collaborative effects~     of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope~     to better understand the clinical significance and long-term cognitive effects of~     microemboli. This proposal may change our current clinical practice by providing a better~     outcome measure for carotid interventions and improving outcomes of CAS procedures through~     risk factor stratification. Our central hypothesis is that development of subclinical~     microemboli is associated with decline in cognitive function following CAS and that the risk~     of development of microemboli themselves is associated with patient- and procedure-related~     factors. We hope that this prospective study will help to clarify these important issues in~     the era of rapidly evolving percutaneous interventions.~   "
102259|NCT01718587|"~     The current treatment methods of liver cirrhosis are limited ,including antiviral~     therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive~     therapy especially the regularly intravenous infusions of plasma or albumin are combined in~     the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem~     cell with self and directed differentiation capacity can effectively rescue experimental~     liver failure and contribute to liver regeneration, which suggests the feasibility of stem~     cell transplantation therapy. In this study, the safety and efficacy of umbilical cord~     mesenchyma stem cell transplantation through interventional procedures and classical therapy~     in patients liver cirrhosis will be evaluated and compared.~   "
102260|NCT01718574|"~     The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a~     sense of empowerment, coping, quality of life and reducing distress for patients with~     cancer.~   "
102261|NCT01718561|"~     In general anesthetic the patient is deprived of his awareness and ability to breathe. It is~     therefore one of the most important tasks in anesthesia to ensure the patient's airway and~     breathing. It has been shown both in Denmark and internationally that failed management of~     the patient's airway is the main anesthesia-related cause of death and brain damage.~     Therefore, it is very important and highly prioritized among anesthesia personal, to be able~     to identify patients with a difficult airway. The aim of The DIFFICAIR Trial is to reduce~     the incidence of UNEXPECTED difficult airway management by optimizing assessment of the~     patient's airway before anesthesia. There is an international consensus on the importance of~     proper identification of patients with a difficult airway prior to anesthesia. Enabling~     optimal preparation and thus reducing mortality and complications. The DIFFICAIR Trial is a~     nationwide multicentre trial with approx. 70,000 patients. 28 of the country's anesthesia~     departments is randomized either to airway assessment based on the physicians' clinical~     judgment (current practice) or to use an objective risk score for airway evaluations~     including anatomical conditions known to be associated with difficult airway management.~     Data from The Danish Anesthesia Database is used to compare the success rates of the two~     methods. We hope that by using a systematic airway assessment we may reduce the number of~     unexpected difficult airway managements and thereby reducing the associated complications~     and death. Based on data we will contribute to a national recommendation for airway~     assessment before anesthesia.~   "
102262|NCT01718548|"~     Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many~     years for treatment of a variety of conditions. The aim of this study is to evaluate the~     effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on~     cardiopulmonary fitness and cognitive functioning in young, healthy physical education~     students.~   "
102263|NCT01718535|"~     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a~     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3~     and *17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed~     to demonstrate the concordance (positive and negative percent agreement) by comparing the~     Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the~     concordance between three different sample transport embodiments provided to laboratories~     for use in transporting the reagent tubes with collected buccal sample swab to the~     laboratory.~   "
102264|NCT01718522|"~     The purpose of this registry is to collect the real life data on Sensor Augmented pump~     therapy usage in type 1 DM patients treated with Medtronic Insulin pumps and countinuous~     glucose monitoring systems in Germany.~   "
102265|NCT01718509|"~     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with~     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating~     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as~     days during which at least 1 binge episode occurs) per week as assessed by clinical~     interview based on subject diary~   "
102266|NCT01718496|"~     The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea~     and exercise tolerance in COPD patients.~   "
102267|NCT01718483|"~     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with~     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating~     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as~     days during which at least 1 binge episode occurs) per week as assessed by clinical~     interview based on subject diary~   "
102268|NCT01718470|"~     Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes~     that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more~     favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge~     from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after~     insertion of a ProSeal LMA to replace the endotracheal tube (ETT).~   "
102281|NCT01718301|"~     The primary objective of this study is to evaluate the safety and efficacy of a Response~     Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination~     with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1~     infected patients that failed to previous HCV therapy.~   "
102282|NCT01718288|"~     Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients~     with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery~     both in patients for which it is only possible medical therapy~   "
114214|NCT01561209|"~     The objective of this prospective randomized and controlled study is to evaluate the~     efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck~     pain.~   "
102269|NCT01718457|"~     Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated~     by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause~     further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with~     weight loss as an alternative to bariatric surgery for patients who are not interested or~     not qualified for surgery. The aim of this study is to assess the efficacy and safety of the~     Endobarrier Diabesity patients in Israel.~      This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8%~     and above and a BMI of 30 kg/m2 or above.~      Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these~     medications.~      The cohort will be followed for two years during which the patients will be monitored for~     diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid~     profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and~     change in plasma gut peptide levels. The Endobarrier will be explanted after one year,~     however the monitoring of the patients will continue for another year.~   "
102270|NCT01718444|"~     Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility~     treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However,~     some preliminary data suggest that skipping PIES could result in a higher live birth rate.~     The investigators are performing the first randomized controlled trial to find out if~     skipping the use of progestin during fertility treatment of anovulatory PCOS women is~     associated with improved pregnancy and live birth rates compared to the traditional approach~     of using progestin prior to use of clomiphene citrate.~   "
102271|NCT01718431|"~     This study aims at investigating the impact of colonic fermentation of intrinsic~     indigestible carbohydrates in cereal whole kernels after three days consumption, on~     metabolic variables and cognition. The study is performed in healthy, normal to slightly~     over-weight test subjects.~   "
102272|NCT01718418|"~     The purpose of the study is to evaluate food factors related to colonically derived~     regulation of glucose metabolism (and related parameters) and satiety using a semi-acute~     meal study in healthy subjects as experimental model.~   "
102273|NCT01718405|"~     Studies have shown that an acute bout of aerobic exercise positively effects cognition,~     mainly executive functioning; however the effect is not observed among all people and it is~     not clear whether only aerobic exercise can produce this effect or possibly also resistant~     exercise. The main purpose of our study is to examine whether genetic variation is a~     moderator of this effect and whether resistant exercise is comparable to aerobic exercise in~     improving cognition following a single bout of exercise.~   "
102274|NCT01718392|"~     the purpose of this study is to investigate the development of insulin resistance in~     multiple sclerosis patients + explaining the effects of a combined training programme on~     insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients~   "
102275|NCT01718379|"~     The goal of the present study is to assess, through a randomized phase II trial, the~     efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,~     ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5~     abnormality.~      Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4~     months. Responders will be eligible for maintenance treatment with cycles identical to the~     first cycles, until relapse occurs or until unacceptable toxicity.~   "
102276|NCT01718366|"~     Determinate safety and response rate of the association Deferasirox -Vitamine D -~     Azacitidine in treatment of high risk MDS~      Deferasirox Exjade:~      The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is~     scheduled during the phase I, with 5 additional patients per group.~      The maximal tolerated dose of Deferasirox will be required for the phase II of the study.~      The first dose will be assigned according to the ferritin level of the patient at time of~     inclusion:~      5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin~     is ≥1000ng/ml) in Group 2~      Group 1 : Ferritin 300 to 1000ng /ml:~        -  cohort 1 : 5 mg/kg/d~        -  cohort 2 : 10mg/kg/d~        -  cohort 3 : 15 mg/kg/d~      Group 2 : Ferritin > 1000ng /ml:~        -  cohort 1 : 10 mg/kg/d~        -  cohort 2 : 15mg/kg/d~        -  cohort 3 : 20 mg/kg/d~           5 patients will be treated by cohort. In absence of toxicity (extra-hematological~          toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included~          in the next cohort.~      Deferasirox will be administrated once daily during all the study period. Uvedose will be~     administrated once weekly during all the study period (100.000 UI P.O).~      Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each~     cycles(One cycle is 28 days)~      During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine~      Patients will be received 6 cycles of treatment (except if progression, unacceptable~     toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done~     to evaluate the efficacy of the treatment.~      No dose modification of deferasirox will be done after 3 cycles of treatment except in case~     of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with~     the same dose of Deferasirox until progression .~   "
102277|NCT01718353|"~     Primary Objectives:~        -  To explore the benefit of an early switch from docetaxel/prednisone to cabazitaxel/~          prednisone in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who do~          not achieve ≥30% prostate-specific antigen (PSA) decline from baseline by cycle 4 with~          the initial docetaxel treatment.~        -  To evaluate the circulating tumor cells (CTCs) with clinical response/resistance to~          docetaxel or cabazitaxel treatment.~      Secondary Objectives:~        -  To assess efficacy and safety of the two treatment strategies, switch from~          cabazitaxel/prednisone to docetaxel/prednisone and docetaxel/prednisone to~          cabazitaxel/prednisone.~        -  To evaluate efficacy in patients receiving initial taxane treatment before the switch~          and efficacy under the alternate taxane after the switch within each initial treatment~          group.~      To explore:~        -  Ribonucleic acid (RNA) sequencing on CTCs to assess for tubulin mutations and androgen~          receptors (AR) isoforms.~        -  Deoxyribonucleic acid (DNA) sequencing on CTCs to validate RNA sequencing results.~        -  To measure PSA response (≥30% and ≥50% reduction in PSA from baseline) in patients who~          have been previously treated with a high potency AR-targeted agent (AR signaling~          inhibitor or CYP 17 inhibitor).~   "
102278|NCT01718340|"~     The prevalence of insulin resistance is increased in women with recurrent miscarriage~     compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only~     implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical~     complications during pregnancy.An elevated free androgen index appears to be a prognostic~     factor for a subsequent miscarriage in women with recurrent miscarriage.~      There is insufficient evidence to evaluate the effect of metformin supplementation in~     pregnancy to prevent a miscarriage in women with recurrent miscarriage.~   "
102283|NCT01718275|"~     The purpose of this study is to determine the feasibility of non-operative management of~     early appendicitis in children. We hypothesize that non-operative management of early~     appendicitis in children with antibiotics alone will be successful in 80% of children at 1~     year follow-up.~   "
114614|NCT01556204|"~     The objective of this study is to conduct a prospective randomized controlled trial of~     robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.~   "
102284|NCT01718262|"~     The purpose of the study is to measure the blood levels of the medicine called ropivacaine~     (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not~     the subject of this study, but the investigators are studying how much of the drug can be~     found in the patient's blood, known as the blood level, of this medicine. Too much~     ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve~     catheter is removed, local anesthetic toxicity is no longer a potential problem. However,~     there is little data on what ropivacaine blood levels are after having the catheter in for a~     long period of time(up to one month).~   "
102285|NCT01718249|"~     Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest~     that deep brain stimulation of the thalamic-tegmental reticular system could improve~     consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this~     protocol is to study the effects of deep brain stimulation on conscious behavior, using a~     patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised~     (CRS-R) as clinical assessment criterion.~   "
102286|NCT01718236|"~     The project aims to introduce into clinical practice for Caesarean section conducted under~     general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal~     of neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same~     efficiency and confirm the safety of the procedure for both mother and newborn compared with~     older procedure.~   "
102287|NCT01718223|"~     This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in~     treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy~     uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active~     when it is exposed to light. When the drug is active, tumor cells are killed. Giving~     photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
102288|NCT01718210|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may~     improve the embryo implantation in patients experiencing recurrent implantation failure in~     IVF cycles.~   "
102289|NCT01718197|"~     The mission of SARP is to improve the understanding of severe asthma through integrated~     study of its clinical and biological features and to evaluate their changes over time. The~     ultimate goal of these efforts is to promote better treatments for severe asthma.~   "
102290|NCT01718184|"~     A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric~     intraocular lens in pseudophakic patients for correcting refractive errors following corneal~     transplantation~   "
102291|NCT01718171|"~     Although the presence of SIRS has been described in patients with appendicitis, its~     progressive response related and together with progression of symptomatology from the onset~     of symptoms to diagnostic has not been characterized. Continuation of the systemic~     inflammation in patients with injury and infectious processes may result in multiple organ~     dysfunction and ultimately failure. As with any acute inflammatory condition, the patients'~     systemic inflammatory response to appendicitis will progress and become more intense with~     the passing of time. The purpose of this study is to characterize the systemic inflammatory~     response to appendicitis from the beginning of symptoms to diagnostic in patients with~     appendicitis submitted to emergency surgery.~   "
102292|NCT01718158|"~     The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,~     given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective~     as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in~     subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received~     any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment~     with Pegylated Interferon Alfa + Ribavirin~   "
102293|NCT01718145|"~     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032~     combination therapy in Japanese subject.~      The purpose of this study is to compare the anti-viral activity of the co-administration of~     Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese~     Hepatitis C virus (HCV) subjects~   "
102294|NCT01718132|"~     Aim of this prospective study was to assess the quality of postoperative care in a~     postoperative anaesthesia care unit (PACU) using postoperative pain, nausea and vomiting as~     well as their reduction as quality markers. So far, only sparse data related to this topic~     are available and there are currently no established quality markers of a PACU service.~   "
102295|NCT01718119|"~     The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and~     Ovidrel for inducting final follicular maturation and early luteinization in women~     undergoing ovulation induction for assisted reproduction treatment~   "
102296|NCT01718106|"~     Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long~     coronary stenoses but this strategy is expensive and the response to overlapping DES has not~     been extensively studied. The recent availability of bioabsorbable polymer DES could allow~     treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer~     in the vessel wall, even in case of overlapping stents.~      Thus we planned to evaluate which of the 2 strategies, namely using a single long~     biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in~     treating long coronary stenoses.~      The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients~     with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be~     randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will~     be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril~     Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by~     2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study~     will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month~     overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis~     and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by~     6-month control coronary angiography and late lumen loss in the stented vessel will be~     measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara,~     Italy)~   "
102297|NCT01718093|"~     The purpose of this study is to see if the use of metformin and sitagliptin used in~     conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.~   "
102299|NCT01718067|"~     Mechanical devices to increase the individual's bronchial hygiene are commonly used to~     assist patients with chronic retention of secretions. VAKÜM technology has been recently~     developed with the aim to improve the respiratory condition in hypersecretive patients~     suffering from chronic respiratory diseases.~      The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients~     with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.~      Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die),~     and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred~     to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind~     multicentre randomized trial with consecutive recruitment. Following a preliminary run-in~     period, group comparison will be made between Intervention group using VAKÜM system (Free~     Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group~     using manual ELTGOL alone over 10 daily sessions.~      Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of~     life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale),~     sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory~     air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary~     outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point~     (SD 5) group difference change in the primary outcome at the end of the study period as~     significant at the 0.05 level, at least 42 patients per group are needed. The minimum target~     sample size will be then fixed at 50 patients per group.~      An higher and faster significant reduction of the perceived dyspnea is supposed in the~     Intervention group. Additional benefits among the secondary outcomes are also hypothesised~     in the same group.~   "
102300|NCT01718054|"~     Sickle cell disease (SCD) is the most common inherited disorder worldwide affecting 300,000~     births annually, most occuring in sub-Saharan Africa (SSA) where poor detection and care~     result in high childhood mortality, malnutrition, illness and disability in survivors. SCD~     is caused by abnormal haemoglobin, the compound in red blood cells(RBC) that carries oxygen.~     Much of the disability in SCD may be caused by vascular damage from the breakdown of damaged~     RBC. Research in high-income countries has led to some effective therapies but these are~     currently costly and complex. The investigators will test two different formulations of an~     affordable, ready-to-use supplementary food (RUSF) specifically tailored for children with~     SCD. As well as containing energy, protein, essential fats, vitamins and minerals, the~     vascular RUSF (RUSFv) will be fortified with the amino-acids arginine and citrulline and be~     delivered with a daily chloroquine dose to create a novel nutraceutical intervention.~     Arginine is converted to nitric oxide which is essential for vascular health. Arginine~     levels are low in SCD because the arginine-degrading enzyme, arginase, is released from~     RBCs. The investigators propose that by supplying additional arginine (and citrulline which~     converts to arginine) and suppressing arginase activity (an action of chloroquine) the~     investigators can improve vascular function. Our study will test this theory, and if~     provision of RUSF improves growth in children with SCD.~   "
102301|NCT01718041|"~     This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients~     with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a~     single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6~     months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary~     endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.~   "
102302|NCT01718028|"~     The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a~     day for 30 days to increase non-invasive tear film break up time over baseline, compared to~     a saline control, in dry eye subjects with lipid deficiency.~   "
102303|NCT01718015|"~     Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP)~     remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism.~     The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for~     development and regeneration of the nervous system. In earlier studies reduced~     concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle~     and skin biopsies have been found in patients with DP.~      Purpose: Our purpose is to determine the concentration and biological activity of~     Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163~     (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and~     Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with~     diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy~     control subjects. We will furthermore relate the findings to peripheral nerve function. In~     addition the composition of the cerebrospinal fluid will be analyzed using mass~     spectrometry.~      Hypothesis: We hypothesize that DP develops due to reduced concentration and biological~     activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and~     BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients~     without damage to the nervous system and healthy control subjects.~      Methods: Study subjects consists of patients from Department of Neurology and Department of~     Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital,~     Denmark, who are having a lumbar puncture performed.~   "
102304|NCT01718002|"~     The care of the oral cavity is an important way to prevent local and systemic infections.~     This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for~     patients undergoing chemotherapy. The methodological design used was quasi-experimental~     before-after intervention. The sample consisted of 23 subjects who performed the technique~     of oral hygiene before and after watching an educational video. To do so was given a kit~     with a toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product~     to mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric~     test t Student paired.~   "
102305|NCT01717989|"~     To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and~     during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy~     [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement~     for all dialysis services. Specifically, to describe CMS ESRD PPS quality performance~     measures for dialysis centers over time.~   "
102317|NCT01717833|"~     The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for~     muscle weakness following critical illness. The investigators hypothesized that NEMS~     combined with exercise rehabilitation will have a beneficial role in restoration of muscle~     strength~   "
102318|NCT01717820|"~     The purpose of the study is to provide whole-grape powder or a placebo as a supplement to~     postmenopausal women for 12 weeks to determine the effects on body composition and bone~     formation.It is hypothesized that 12 weeks of supplementation with whole-grape powder will~     decrease body fat via resveratrol's positive effects on metabolism and negative effects on~     fat cells.~   "
102306|NCT01717976|"~     The Veterans' Health Administration (VHA) is committed to improving primary care through the~     implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care~     coordination are among the primary goals of PACTs; however, there remain many unanswered~     questions about how best to use the limited time of PACT team members, such as nurse care~     managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led~     telephone support program for Veterans who have been treated recently in the emergency~     department (ED) and are at high risk for repeat visits. The program's goals are to reduce~     the need for future ED use and improve satisfaction among Veterans by providing information~     and support related to the ED visit, enhancing chronic disease management and educating~     Veterans and family members about PACT and other VA and community services. If proven~     effective, this program could improve health and healthcare for a large, vulnerable group of~     Veterans and be cost saving for VHA.~   "
102307|NCT01717963|"~     Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse,~     overdose and overdose death. This risk is elevated even further following discharge from~     treatment or correctional institutions where patients have been detoxified. At the moment,~     state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake~     of opioid medications like methadone or buprenorphine. Recently, a medication containing the~     blocking agent naltrexone was approved in the US; this does not maintain dependence but~     instead blocks heroin and other opioids for 28 days after intramuscular administration. This~     study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension~     (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge~     from a treatment or correctional facility to participating catchment regions in Norway. The~     main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the~     proportion of biological samples negative for opioids, retention, self-reported use of~     alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week~     period where participants can receive the study medication of their choice. After the end of~     the study, data from national registry databases can be collected for a further 12 months on~     outcomes such as recidivism, mortality and morbidity.~   "
102308|NCT01717950|"~     Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic~     cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1~     has protected animals from infection in challenge studies. This study will evaluate the~     safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers~     when co-administered with different concentrations of the immunostimulant GLA-AF.~   "
102309|NCT01717937|"~     The purpose of this study is to determine whether phase variance optical coherence~     tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing~     technology, can be used to generate angiographic images of the retinochoroidal vasculature~     that are comparable to those produced by fluorescein angiography (FA), the current gold~     standard diagnostic test.~   "
102310|NCT01717924|"~     The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled~     trial comparing primary surgery versus primary chemotherapy followed by surgery in patients~     with a resectable signet ring cell gastric adenocarcinoma~   "
102311|NCT01717911|"~     We have found that a 6-month course of insulin therapy after a short-term intensive insulin~     therapy could shorten the period of hyperglycemia to preserve ß-cell function and further~     improve long-term glycemic control in recently diagnosed type 2 diabetes with severe~     hyperglycemia (>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus~     hypothesized that a 6-month course of basal insulin therapy could also help to preserve~     ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300~     mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin~     therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the~     diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with~     better ß-cell function reservation. We skip a short-term intensive admission course of~     insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe~     hyperglycemia.~   "
102312|NCT01717898|"~     There will be two parts to this clinical research study. The purpose of each part is:~        -  Phase 1: This part of the study will determine what dose of BEZ235 is safe to give with~          a standard dose of abiraterone acetate and prednisone by administering different doses~          of BEZ235. This will help to find out what effects, good and/or bad, this combination~          has on CRPC.~        -  Phase 2: This part of the study will measure the treatment effect of the combination of~          BEZ235 and abiraterone acetate/prednisone on CRPC.~   "
102313|NCT01717885|"~     The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa.~     Malaria is one of the most important infectious diseases in the world. Uganda reports among~     the highest transmission intensities in the world. Children and pregnant women are the most~     vulnerable populations. HIV is also reported at high rates for these populations. If malaria~     and HIV require treatment at the same time, there is a high risk for drug-drug interactions.~     This study will:~        1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r),~          nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of~          antimalarial medications (specifically artemether-lumefantrine, AL) during the~          treatment for uncomplicated malaria in HIV-infected children and pregnant women, and~        2. Evaluate the impact of age and pregnancy on the PK exposure of AL.~   "
102314|NCT01717872|"~     To compare the laryngoscopy view using two standard clinical devices, the Macintosh and~     Miller laryngoscopy blades, in infants between one day and two years of age.~      Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in~     pediatric clinical practice in some institutions especially in infants. The anatomy of~     infant airway has traditionally been considered to lend itself to advantages of the Miller~     blade. Some argue that the Miller blade offers a superior view of the laryngeal inlet~     because it lifts the epiglottis. However, others use the Miller blade to expose the larynx~     without lifting the epiglottis, supposedly to avoid traumatizing it. Despite the~     long-standing use of these blades, more than 50 years, no systematic study has ever compared~     the laryngoscopy views of the Miller and Macintosh blades in infants.~   "
102416|NCT01716546|"~     Investigators propose to study the effect of panitumumab when combined with an active~     regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients~     with advanced cancer of the stomach.~   "
102319|NCT01717807|"~     The EGFR is one of the most frequently overexpressed proteins in various cancers including~     lung cancer, and is related to tumor progression and resistance to most treatments.~      New treatment strategies targeting EGFR have been developed: although much work remains to~     be done, erlotinib has already established itself as part of the therapeutic armamentarium~     against cancer(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ.~     Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)~      Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could~     aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.~      Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant~     tumor burden before the initiation of therapy with EGFR inhibitors.~      The purposes of the study are:~        1. To adjust an optimal treatment for patients with tumors that have high expression of~          EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during~          pretreatment work-up; as well as to follow up after treatment response.~        2. To recognize patients with advanced pancreatic cancer responding to treatment with~          erlotinib and to distinguish them from non-responders.~   "
102320|NCT01717794|"~     This prospective randomized pilot study is aimed to verify if the operative time of a TLH~     with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using~     Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and~     bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .~      Secondary endpoints of this comparison are incidence of intra- or postoperative~     complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or~     other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS),~     days of hospitalization and costs for the health care system.~   "
102321|NCT01717781|"~     This prospective randomized pilot study is aimed to verify if the operative time of a LRH~     with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm)~     and for advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to~     neoadjuvant chemotherapy with complete clinical response could be reduced using Thunderbeat~     (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar~     technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .~      Secondary endpoints of this comparison are incidence of intra- or postoperative~     complications, estimated blood loss, postoperative pain, days of hospitalization and costs~     for the health care system.~   "
102322|NCT01717768|"~     Low testosterone is a condition that occurs when the body is unable to produce sufficient~     quantities of testosterone. The medical name for low testosterone is hypogonadism.~     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of~     energy and mood swings. The goal of testosterone replacement therapy is to return~     testosterone levels to the normal range and relieve symptoms.~      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone~     provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within~     the normal range in hypogonadal men. This will be determined by blood sampling at specified~     times during the study. The study is also intended to evaluate the tolerability of TSX-002,~     which will be taken orally twice per day for 15 days. In addition, the study is intended to~     determine a dosing regimen(s) that achieves testosterone levels within the normal range.~     Related Outcome Measures will be reported for Parts 1, 2, and 4.~      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal~     on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be~     reported for Part 3.~   "
102323|NCT01717755|"~     Rationale: Recently our study group reported the results of the Basilar Artery International~     Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic~     basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we~     continue to lack a proven treatment modality for patients with an acute BAO and that current~     clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial~     thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute~     symptomatic BAO is challenged by our data. The BASICS registry was observational and has all~     the limitations of a non-randomised study. Interpretation of results is hampered by the lack~     of a standard treatment protocol for all patients who entered the study.~      Objective: Evaluate the efficacy and safety of IAT in addition to best medical management~     (BMM) in patients with basilar artery occlusion.~      Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.~      Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar~     occlusion.~      Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.~     IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part~     of BMM, IVT should be started within 4.5 hours of estimated time of BAO.~      Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin~     Score (mRS - functional scale) of 0-3.~   "
102324|NCT01717742|"~     Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural~     empyema) around the lungs in children. The incidence of pleural empyema in children has~     increased significantly in the last 10 years.~      Short term morbidity for this condition is substantial, but unlike in adults, the long term~     outcome of this condition for children in developed countries is favourable. Inserting a~     chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down~     organized pus has been shown to be an effective therapy for reducing the duration of~     illness. However, this treatment is still suboptimal and prolonged hospitalization is~     common. Recent data from adults suggests that adding an additional medicine (DNase) to~     decrease the viscosity (thickness) of the fluid improves drainage and leads to better~     patient outcomes; however, there are no published studies on children.~      This is a multi-centre randomized controlled trial comparing the time to discharge from~     hospital after chest drain insertion in previously well children who present with pleural~     empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest~     drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone.~     Other outcomes related to effectiveness, safety and cost will be assessed as well.~   "
102325|NCT01717729|"~     To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and~     percutaneous iodine-125 (125I) seeds implantation results in better survival compared with~     use of RFA alone in patients with hepatocellular carcinoma.~   "
126413|NCT01401075|"~     Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM®~     Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.~   "
102326|NCT01717716|"~     The purpose is to determine the effect of sugars in solution on food intake and subjective~     appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food~     intake after all sugars-containing solutions will be decreased in comparison to the control~     solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and~     sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55,~     sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30,~     45, 60 and 90 minutes.~   "
102327|NCT01717703|"~     The purpose of this experiment was to describe the effect of consuming 350 ml of 1%~     chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food~     intake when compared to cola, a fruit drink and a water control in normal weight and~     overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk~     will increase meal time satiation to a greater extent than other sugars-sweetened~     commercially available beverages. Food intake will be measured 60 minutes after the~     consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.~   "
102328|NCT01717690|"~     The purpose of this study is to determine whether daily bathing with 2% chlorhexidine~     gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of~     colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus~     (MRSA).~      Investigators postulate that daily bathing with CHG significantly reduces incidence of~     colonization of hospitalized patients with MRSA.~   "
102329|NCT01717677|"~     4arms preference based Study to compare four therapy options in prostate cancer with low or~     early intermediate risk~   "
102330|NCT01717664|"~     The investigators hypothesize that Mycobacterium avium paratuberculosis positive Relapsing~     Remitting MS subjects will have a greater response to Interferon beta-1a therapy plus~     RHB-104 than from Interferon beta-1a alone.~   "
102331|NCT01717651|"~     This study is being done to help determine whether patients with severe sepsis (overwhelming~     inflammation in the body as a result of an infection) lose muscle and become weak more~     rapidly than patients with other severe illnesses. Weakness and muscle loss that develops~     after a severe illness is a serious problem. Patients who develop weakness and have a~     decrease in muscle size often have to stay in the hospital longer and have a higher chance~     of dying. At the current time, it is not clear whether certain severe illnesses are more~     likely to cause weakness and muscle loss. This study will be done to measure the changes in~     muscle size and strength as a result of each patient's illness~   "
102332|NCT01717638|"~     It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second~     extension study is to explore the bactericidal antibody persistence in 4-year-old children~     after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV~     NZ administered to toddlers as part of their respective vaccination courses in study~     V72P12E1.~      In addition, this study will characterize the antibody response to a fifth dose boost in all~     children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age~     (in parent study V72P12, NCT00721396), and only in a subset of children who received a~     three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).~     Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ~     administered at approximately 4 years of age in all children who received a two catch-up~     doses of rMenB+OMV NZ as toddlers in study V72P12E1.~      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2~     months apart to healthy naïve children at 4 years of age will be assessed.~   "
102333|NCT01717625|"~     This study is multicentered, prospective, randomized, opened, parallel, intervention study.~      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the~     prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational~     age.~      The investigators evaluate the first effectiveness through the morbidity and mortality of~     bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness~     through the oxygen index, the usage of mechanical ventilator about taking medicine after 2~     Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial~     lavage fluid.~   "
102334|NCT01717612|"~     Though histoacryl injection is now regarded as treatment of choice in the control of gastric~     variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer~     bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On~     the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding~     gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were~     between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without~     inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been~     reported.~   "
102335|NCT01717599|"~     Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are~     potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only~     one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD~     (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore~     the investigators must need large scaled randomized control study including of SOD.~   "
102336|NCT01717586|"~     The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters~     and collect preliminary safety data for pravastatin when used as a prophylactic daily~     treatment in pregnant women at high risk of preeclampsia.~   "
102348|NCT01717430|"~     Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used~     for the treatment of chronic neck, low back, and leg pain. These injections may have several~     side effects, including suppression of the body's adrenal glands to produce steroids~     (adrenal suppression) and negative effects on metabolism (weight gain, increased blood~     pressure, and high blood sugar levels).~      The purpose of this study is to determine the time course and predictors of adrenal~     suppression and the metabolic effects of corticosteroid injections for chronic pain.~      The investigators hypothesize normalization of adrenal function to occur within three weeks~     of injection in most individuals. An increased frequency of injections is predicted to lead~     to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to~     increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic~     individuals.~   "
102417|NCT01716533|"~     This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and~     2) explore the difference in immune response between the patients with CDI recurrence and~     those with a sustained clinical response.~   "
102337|NCT01717573|"~     During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The~     mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus~     formation and vascular spasm. No reflow is associated with risk factors such as prolonged~     duration of ischaemia, heavy thrombus burden, persistent ST elevation and long stent length.~     ACTIVE HYPOTHESIS: once normal antegrade flow has been re-established with initial~     aspiration thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared~     with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to~     permit the beneficial effects of normalized coronary blood flow and anti-thrombotic~     therapies will reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In~     consecutive STEMI patients with risk factors for no reflow and who have given informed~     consent, when normal flow has been established (TIMI 3) by initial aspiration thrombectomy~     and/or balloon angioplasty, participants will be randomized to deferred stenting or usual~     care with direct stenting. All patients will receive dual anti-platelet therapy. Patients~     who are randomized to deferred stenting will receive intravenous glycoprotein IIbIIIa~     inhibitor and anti-coagulation with low molecular weight heparin. Patients who are screened~     and not eligible to be randomized will be prospectively entered into a registry. Study~     assessments for feasibility, safety and efficacy will be prospectively performed. An~     independent clinical event committee will review all serious adverse events. Study endpoints~     will be subject to core laboratory analyses. The study is intended to inform the design of a~     larger multicentre clinical trial.~   "
102338|NCT01717560|"~     The purpose of this study is to examine the feasibility, safety, and effectiveness of~     treating persons who are actively using illicit drugs for hepatitis C using a collaborative,~     multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and~     minimizing barriers to treatment we can enable drug users to receive effective treatment for~     hepatitis C.~   "
102339|NCT01717547|"~     The aims of this research study are to 1) assess the acceptability and feasibility of~     conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs~     Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on~     Veteran's mental health.~   "
102340|NCT01717534|"~     The purpose of the planned study is to investigate the effect of heat-treated lactobacilli~     on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,~     placebo-controlled study.~   "
102341|NCT01717521|"~     Researchers at the UW are doing this study to find out if a commonly used anesthetic affects~     patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy~     under general anesthesia.~      The investigators will administer routine anesthesia care including Ketamine, a commonly~     used anesthetic, during the patients surgery. During the patients surgery, the investigators~     will monitor the patients level of pain relief using the PhysioDoloris monitor, which~     monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is~     completely non-invasive and collects data from the EKG monitor.~   "
102342|NCT01717508|"~     The goal of the study is to examine how cognitive behavioral therapy (CBT), a common~     treatment for adolescent depression, affects brain functioning. Depressed adolescents will~     complete an initial assessment consisting of an interview, questionnaires, computer tasks,~     and an EEG recording. EEG (electroencephalography) measures brain activity by recording the~     electrical activity along the scalp caused by the firing of neurons within the brain. They~     will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes~     long and held once a week for 12 weeks. Before their third therapy session, participants~     will complete a computer task while EEG data are recorded. After completing the treatment,~     the participants will complete a final assessment, which will include questionnaires,~     computer tasks, and an EEG recording. They will also complete follow-up assessments over the~     phone 1, 3, and 6 months after completing the treatment.~      This study will also include healthy control participants. They will complete an initial~     assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording.~     Three weeks later, they will return to complete a behavioral task while EEG data are~     recorded. Twelve weeks after the initial assessment, they will complete a final assessment,~     which will include questionnaires, computer tasks, and an EEG recording.~   "
102343|NCT01717495|"~     This is a large prospective registry of patients submitted to cardiac electronic devices~     implantation designed to investigate the incidence, risk factors and prognostic of~     thromboembolic complications associated with transvenous lead implantation.~   "
102344|NCT01717482|"~     The purpose of this study is to learn whether it is better to receive the drug Metformin~     with standard of care for lung cancer or just standard of care.~   "
102345|NCT01717469|"~     Previous experimental and clinical studies have consistently suggested that right~     ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however,~     is required, and cannot be reduced in many patients with atrioventricular block. The~     SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional~     right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.~   "
102346|NCT01717456|"~     In previous studies at a university referral center the investigators demonstrated that a~     multicomponent conservative treatment for fecal incontinence was effective. The treatment~     combines patient education with medical management of diarrhea and constipation plus~     behavioral training. The purpose of this study is to determine whether this treatment is~     effective when delivered by home health care nurses to frail elderly patients.~   "
102347|NCT01717443|"~     The purpose of this study is to examine the prevalence, incidence and genotype of anogenital~     HPV infections in women before and after renal transplantation. With this information the~     investigators can determine the value of vaccination in patients waiting for renal~     transplantation in the future.~   "
102362|NCT01717248|"~     The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic~     kidney disease.~   "
102418|NCT01716520|"~     The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI~     in individual patients using a cross-over design. This is a multicenter, randomized,~     double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of~     UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment~     once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period.~     There will be a 5-7 day run-in period prior to randomization.~   "
102349|NCT01717417|"~     Maxillary canines are the second-most frequently impacted teeth in the dental arch after the~     third molars. The suspicion of a maxilary canine impaction raises with the absence of the~     permanent canine in the arch after the normal period of eruption, and has to be confirmed by~     a clinical evaluation of the patient and a radiographic assessment.~      The approaches to the management of impacted canines are many, but the preferred approach~     typically involves surgical exposure and guided orthodontic eruption.~      The initial mechanical eruption can be achieved in several ways, but an important~     distinction has to be done according to the anchorage method. The aim of this study is~     comparing Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using~     the quantification of canines and molars displacement as the main parameter.~      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic~     anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the~     need for it at large, and is subsequently removed after use.~      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with~     1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area~     between the first premolar and first molar, on the buccal or labial side according to the~     canine position and teeth position.~      For the evaluation of the canines and molar displacement, two CBCT will be required: the~     first one before the beginning of the traction (T0), the second one after three months (T1).~     Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,~     Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of~     interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,~     through the identification of 5 at least landmark points, will allow the overlap of the two~     masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment~     positions will be evident and the measurement of the displacement possible.~   "
102350|NCT01717404|"~     To understand if Mexiletine will restores normal colonic motility in a patient with~     irritable bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.~   "
102351|NCT01717391|"~     [F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan~     to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone~     marrow will help maintain blood counts. This would impact chemotherapy administration.~   "
102352|NCT01717378|"~     The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides~     recruitment services and facilitates the enrollment of research participants into UCSF~     clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and~     affiliated institutions and will address the common problems that investigators encounter in~     the recruitment process.~      Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA~     regulations for ensuring human subject rights, participant privacy, and data security into~     the recruitment workflow and data collection/extraction methods. Recruitment Services,~     therefore, requests approval to implement these processes systematically for all studies~     that have already obtained CHR approval to begin recruitment activities.~   "
102353|NCT01717365|"~     Data for the study will be collected from therapist across the world. The therapists will~     share data they have already compiled from their caseload. Data will be stripped of all~     personal identifiers and personal health information. The TWU SCOPE research team has no~     contact with clients whose assessment data is being shared for secondary analysis or~     clinical data repository. For educational and training purposes clients can be videotaped by~     the therapist who will obtain consent and/or assent from the client. Not every client will~     be videotaped. The subjects from the data shared by the therapists are from the ages of~     0-21, both male and female, and of any ethnicity. The total amount of data collected from~     all participating therapists will be 500 pieces.~   "
102354|NCT01717352|"~     The present study will test the effectiveness of two different approaches for preparing~     overweight/obese individuals for weight loss: 1)providing important information about weight~     control, including dispelling common myths; or 2) developing a consistent sleep and eating~     routine to prepare for the challenges of a weight control intervention.~   "
102355|NCT01717339|"~     Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development~     of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but~     given the association between OSA and obesity, adipose-derived hormones (adipokines) are~     likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown~     to be associated with deleterious effects on vascular function resulting in impaired~     endothelial function. This proposal is directed at investigating the molecular mechanisms of~     endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction~     associated with OSA is a result of molecular alterations within endothelial cells. As a part~     of these studies we will look at NO signaling pathways in adipose tissue and microvessels~     from normal and OSA subjects.~   "
102356|NCT01717326|"~     This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with~     elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained~     Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the~     treatment arms.~   "
102357|NCT01717313|"~     The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102),~     dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and~     exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin~     compared with placebo provides greater reduction in hemoglobin A1c (A1C).~   "
102358|NCT01717300|"~     This study will evaluate the effects of 2 different dose levels of anacetrapib on~     low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)~     in participants with hypercholesterolemia when added to an existing statin-modifying~     therapy.~   "
102359|NCT01717287|"~     This multicenter, open-label, noncomparative study evaluates two oral formulations of~     raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other~     antiretroviral agents for safety, tolerability, and antiretroviral activity in~     treatment-naive or treatment-experienced Russian children and adolescents infected with~     human immunodeficiency virus-1 (HIV-1).~      As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for~     the treatment of HIV-1 infection in pediatric patients in the United States (US), this study~     is designed to gain local treatment experience on the use~      of raltegravir in the pediatric HIV-infected population in Russia.~   "
102360|NCT01717274|"~     Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow~     for the best surgical view and to reduce risk while in surgery.~      Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body.~     The investigators would like to determine if hot saline irrigation (HSI) compared to room~     temperature saline irrigation (RTSI) can control bleeding during FESS.~      The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding~     during FESS.~   "
102361|NCT01717261|"~     The purpose of this study is to determine if partial breast irradiation administered in a~     single preoperative fraction is tolerable.~   "
102363|NCT01717235|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the~     clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in~     each period. After maintaining at least 10 hours of overnight fast Test or Reference product~     was administered orally (as per the randomization schedule) to each subject with about 240~     mL of water at ambient temperature in each period by trained study personnel.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples~     were collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00,~     9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study~     period with a washout period of 7 days between the dosing of two periods. Subjects were~     continuously monitored for well being i.e., blood pressure, radial pulse and oral~     temperature before check-in, prior to drug administration and at regular intervals post dose~     in each period. The concentration of Ropinirole in plasma samples obtained from study~     subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical~     analyses were performed on obtained drug concentration data, using appropriate software.~   "
102364|NCT01717222|"~     Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall~     stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and~     intravenous administration of lignocaine has been used. But it is not clear from the~     existing literature which form of administration is more effective for pain relief. Hence~     this study has been undertaken with the following hypothesis : Intravenous lignocaine is~     superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the~     stress response in laparoscopic cholecystectomy.~   "
102365|NCT01717209|"~     Research study evaluating the individual and combined effects of inhaled medications, nitric~     oxide and prostacyclin, on the function of the right heart after surgery for either heart~     transplant or for left ventricular assist device (LVAD) placement. The investigators hope to~     learn if these two medications, when given together after surgery, improve right heart~     function by lowering blood vessel pressures in the lungs. The investigators hope to learn if~     the combined effects of these two medications are better than either medication used alone.~     Participants were selected as a possible participant in this study because right heart~     problems are common during and after surgery for heart transplant and for LVAD placement. In~     addition, the inhaled medication, nitric oxide, is always given during and after these two~     types of surgeries at Stanford to help improve how the right heart functions.~   "
102366|NCT01717196|"~     BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic~     masses. Different needle diameters and the use of stylet are not associated with differences~     in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction~     (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare~     EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different~     aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and~     complications.~      METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo;~     Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was~     performed by five experienced echo-endoscopist. The needle system was in all cases the 22~     gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume~     aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no~     aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples~     were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the~     slides, the material was fixed in formalin for cyto-histological evaluation. The~     cyto-pathologist was always blinded as to which aspiration was used for which specimen.~     After EUS-FNA the patients were monitored for at least six hour to detect immediately~     post-procedural complication and were followed up during the 30 days post-procedure in order~     to detect late complications.~   "
102367|NCT01717183|"~     The main purpose of this trial is to demonstrate that the new dressing is more effective~     than the current dressing in the local treatment of chronic foot ulcers in diabetic~     patients.~   "
102368|NCT01717170|"~     In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity~     of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with~     non-infectious intermediate, posterior, or panuveitis.~   "
102369|NCT01717157|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability~     of 4 new formulations of fentanyl transdermal patch in healthy participants after a single~     application for 72 hours.~   "
102370|NCT01717144|"~     Parkinson's disease (PD) has considerable impact on motor, psychological and social~     activities and significantly affects the quality of life of patients and their families. To~     improve the medical care of PD patients, the investigator have developed an educational~     program specific to PD.~      The principal aim of this study is to evaluate the therapeutic education Program, comparing~     the quality of life of PD patients with or without the educational program after six month~     and one year follow-up.~      The secondary aims are to evaluate the evolution of motor and psychological states in these~     2 groups of patients and to compare the medical costs.~      This is a monocentric, comparative, prospective randomised study. The investigators will~     evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients~     with a traditional medical care. Quality of life of PD patients is evaluated using a~     specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and~     psychological states were assessed with UPDRS and HAD Scales. The educational program~     consisted of both individual and collective educational consultations.~      The investigators supposed that the therapeutic education program will improve the quality~     of life of PD patients. The supposition that this improvement will correlate with the motor~     and psychological states.~   "
102411|NCT01716611|"~     The purpose of the study is to investigate the efficacy and safety for the management of~     hyponatremia and ascites in patients with liver cirrhosis.~   "
102412|NCT01716598|"~     Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve~     trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve~     targeted lung denervation and potentially improve breathing and quality of life for patients~     suffering from COPD.~      Use of the IPS System will be technically feasible in accessing the target treatment~     location and delivering RF energy to the target treatment location.~   "
102419|NCT01716507|"~     This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical~     instrumentation for retinal detachment repair.~   "
102371|NCT01717131|"~     Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the~     hypothesis that omission of additional axillary dissection in case of positive sentinel node~     has a limited impact on overall survival and relapse free survival. However, these data are~     not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in~     case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of~     inclusions and the predefined non inferiority margin was found to be too large (5%~     difference at 5 years for primary endpoint).~      Prospective randomized trial is then urgently mandatory before omission of axillary node~     dissection becomes a usual practice without a sufficient scientific level of proof. Indeed,~     in several reviews, the rate of omission of axillary node dissection in case of~     micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.~      The omission of axillary node dissection in case of positive sentinel node may have strong~     practical impacts on patients but also on medical and economical aspects: in avoiding a~     prolonged hospitalisation, secondary morbidities due to axillary dissection requiring~     secondary care and their costs, as well as costs for secondary axillary dissection (14 to~     25% in case of positive sentinel node) and finally shortening surgery duration.~      The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of~     Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel~     Lymph Node in Invasive Breast Cancer~   "
102372|NCT01717118|"~     In September 2009 the National Vaccination Council approved the policy for anti-HPV~     vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the~     following justification:~        -  Antibody induction due to the vaccine is greater than that produced by natural exposure~          to the virus~        -  Immune response in girls 9 to 11 years of age is similar to the response obtained after~          three doses in women 16 to 26 years of age~        -  The third dose will be administered at the time when maximum protection is required,~          near the onset of sexual activity Thus the National Institute of Public Health was~          commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV~          vaccine to determine non-inferiority of the extended scheme in 9-year-old girls~          compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this~          end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age~          groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who~          are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity~          levels that are not lower than those of adult women who have been administered the~          traditional scheme (0-1/2-6).~      The main objectives are to monitor the levels of immunity induced by vaccination against HPV~     with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60~     months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination~     against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months),~     traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of~     the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study~     design is to create a sentinel cohort of women vaccinated against HPV in the following~     comparison groups:~        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent~          vaccine (0-6-60)~        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent~          vaccine and the third dose with bivalent (0-6-60)~        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV~          vaccine (0-2-6)~        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent~          HPV vaccine (0-2-6)~        -  Women of nine years with extended vaccination scheme with three doses of bivalent~          vaccine (0-6-60)~        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine~          and the third tetravalent dose~        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)~        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine~          (0-1-6)~        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV~          vaccine (0-1-6)~        -  To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15~          years, who have not been vaccinated against HPV, will be invited , in order to make the~          monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post~          dose 0 in vaccinated groups~   "
102373|NCT01717105|"~     The present study has been designed in order to characterize the incidence of patients with~     advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR)~     positive mutations and their clinical management in Galicia.~   "
102374|NCT01717092|"~     Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable~     morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors~     are not well documented in Chinese population. We conducted a prospective, long-term,~     follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an~     acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with~     unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography~     and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary~     angiography. CTPH was considered to be present if systolic and mean pulmonary-artery~     pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure~     was normal; and there was angiographic evidence of disease.~   "
102375|NCT01717079|"~     Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder~     characterized by a resistance to maintaining body weight at or above a minimally normal~     weight for age and height, an intense fear of weight gain or being fat even though~     underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance~     in the experience of body weight or shape. Body weight and shape dissatisfaction is linked~     to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the~     inferior parietal cortex is involved in body image perception and less activated in patients~     with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS)~     is used to modulate cortical excitability, and particularly to increase excitability with~     high-frequency rTMS. The aim of this study was to investigate the effect of excitatory~     high-frequency rTMS over the hypoactive inferior parietal cortex of 54 patients with AN.~      This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000~     ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10~     sessions in two weeks) versus placebo rTMS.~      Assessments will be performed before rTMS and after the last rTMS session (immediately~     after, at 15 days and three months). The principal criteria for judgement is a body image~     satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement~     are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating~     Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety~     rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition~     analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels~     (biomarker for eating disorders recently described).~      Inferior parietal cortex rTMS could not only improve body image perception, but also help in~     the treatment of eating disorders, allowing weight gain with a decreased anxiety and~     improving patients' quality of life. Also positive results could have direct therapeutic~     implications with the possibility to complete regular rTMS sessions, or to implant~     extradural electrodes for chronic parietal cortex stimulation.~   "
102376|NCT01717066|"~     Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the~     efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of~     postoperative recurrence of liver cancer,respectively~   "
102377|NCT01717053|"~     The addition of abiraterone acetate to standard treatment of radiotherapy and short-term~     androgen deprivation will increase the frequency of undetectable PSA.~   "
102378|NCT01717040|"~     The primary objective is to test the hypothesis that adjunctive pioglitazone is more~     effective than placebo for the relief of acute depressive symptoms resulting from bipolar~     disorder. The secondary objectives are to determine potential moderators and mediators of~     antidepressant efficacy.~   "
102379|NCT01717027|"~     To estimate the pharmacokinetics and relative bioavailability of oxycodone after~     administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions~     and after chewing under fasted conditions in healthy volunteers~   "
102380|NCT01717014|"~     The purpose of this research study is to evaluate the safety and feasibility of the Radial~     Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires~     relating to the function of the device.~   "
114710|NCT01554696|"~     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to~     severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).~   "
102381|NCT01717001|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Previously, most experimental~     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested~     the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers~     that permit error due to undesired motions between markers and the underlying bone. More~     recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.~      ConforMIS has attempted to follow a clearly different path than the major orthopaedic~     companies. They have chosen to offer patients a personalized knee implant based off of each~     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will~     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding~     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze~     the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25~     patients implanted with a traditional TKA design to determine if there are any kinematic~     differences between these TKA designs.~   "
102382|NCT01716988|"~     A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment~     success in ICU patients compared with non-ICU patients. It is known that in critically ill~     patients, alterations in function of various organs and body systems can influence the~     pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic~     parameters of micafungin in critically ill patients are most likely different, but this has~     not been specifically studied.~      The pharmacokinetic parameters of micafungin in critically ill patients will be established~     and plasma concentrations of micafungin will be correlated with disease severity.~   "
102383|NCT01716975|"~     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances~     the cognitive abilities of subjects with Schizophrenia who are also taking stable~     antipsychotic therapy.~   "
102384|NCT01716962|"~     Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in~     response to volume load.Low tidal volume and high PEEP exerts contrast effect on the~     prediction of fluid responsiveness, the aim of this study is to compare the relative~     predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and~     pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress~     syndrome ventilated with various PEEP levels or various tidal volumes.~   "
102385|NCT01716949|"~     This trial examines the feasibility, effectiveness and safety of a combination of~     radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and~     Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally~     advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local~     recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively~     improved tumor regression allowing less aggressive surgery in primary locally advanced~     rectal cancer and a higher rate of curative resections in heavily pretreated locally~     recurrent rectal cancers.~      Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of~     radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates,~     and toxicity. It is planned to include a total number of 59 patients over a period of 2.5~     years.~   "
102386|NCT01716936|"~     The purpose of this study is to determine the safety profile and probable benefit of the~     Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity~     associated with thoracic insufficiency syndrome.~   "
102387|NCT01716923|"~     The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per~     the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and~     evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC~     transfusion support for acute anemia.~   "
102388|NCT01716910|"~     This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week~     clinical trial on healthy volunteers. Following a two week run-in-period, subjects were~     randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a~     3-week wash-out period before the second treatment period, followed by a another wash-out~     period. Volunteers completed questionnaires for each period on overall health and well~     being, stool frequency and consistency and gastrointestinal symptoms. The subjects were~     asked to collect fecal samples for investigation of microbiological and microbial~     metabolites before and after three treatment periods. The primary objective of the study is~     tan increase in fecal butyrate concentration. Secondary objectives are changes in microbiota~     composition and short-chain fatty acids.~   "
102389|NCT01716897|"~     This study will be a single-center, open-label, randomized, 3-treatment crossover study of~     single oral doses of an API-capsule formulation of E2609 under fasted conditions and a~     tablet formulation administered under fed and fasted conditions in healthy subjects.~   "
102390|NCT01716884|"~     1. Registration~        2. Performing in three stages~        3. Major aim: Much more and standard reperfusion therapy in STEMI patients~   "
102391|NCT01716871|"~     Introduction: The military population is at high-risk for injury with by painful sprains,~     especially of the ankle. The referenced treatment method for pain is the cryotherapy,~     consisting in applying cold-packs to the injured ankle several times a day. However, another~     pain treatment has been developed and is commonly used by high-level sports teams and~     rheumatologists but its efficacy has never been assessed within a military population, i.e.~     the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.~      Research design: This study was carried out on a French multicenter basis, the study~     consisting in a randomized controlled superiority trial and open-label prospective analysis~     in the treatment of 40-year-old military patients or younger suffering from acute ankle~     sprains. Two groups were made: patients were treated either by neurocryostimulation or by~     the referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six~     supervised 30 minute-sessions within a period of three consecutive days.~      Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity~     resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we~     theorized that the total consumption of paracetamol and the number of days of temporary~     inaptitude and of work exemption were lower in patients treated by neurocryostimulation.~      Outcomes:~      For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning~     and at the end of session 20 minutes later after a four-step walk.~   "
102392|NCT01716858|"~     Accumulating evidence suggests a role of oxidative stress in the pathophysiology of~     schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived~     from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels~     sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation~     of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II~     detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as~     the electrophilic responsive element or antioxidant responsive element. Recently, we~     reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor~     antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a~     hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of~     this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects~     in patients with schizophrenia.~   "
102393|NCT01716845|"~     This study will prospectively enroll approximately 660 children, at least 18 months and less~     than 5 years of age, who have been referred to a pediatric developmental evaluation centers.~     Enrolled children will have blood drawn for RNA gene expression analysis and undergo a~     clinical evaluation to determine the presence or absence of a diagnosis of ASD.~      The sequential co-primary objectives of this study are:~        -  To develop an algorithm to classify blood RNA gene expression patterns to maximize~          agreement between the classification and a clinical assessment of presence or absence~          of Autism Spectrum Disorders (ASD).~        -  To prospectively assess the clinical sensitivity and specificity of the blood RNA gene~          expression classification algorithm (the SDX-002 test) in children referred to a~          developmental evaluation clinic for a possible developmental disorder.~   "
102394|NCT01716832|"~     The effectiveness of a mindfulness walking program is tested in subjects with a high level~     of subjectively perceived stress.~   "
102395|NCT01716819|"~     R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular~     remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin~     aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to~     confirm the hypothesis that RAAS is associated with an early remodelling and implicated in~     the transition to cardiac failure in abdominal obesity.~   "
102396|NCT01716806|"~     This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy~     and safety of brentuximab vedotin as a single-agent (Part A) and in combination with~     dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of~     HL in adults age 60 and above.~   "
102397|NCT01716793|"~     In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50~     years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination~     of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in~     continuous infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10~     mg/m2, 3 days) was administered instead of daunorubicin, the complete remission (CR) rate in~     adults up to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate~     appearing in 50% of patients, the phase II AML-99 trial includes intermediate~     dose-cytarabine during induction and risk-adapted post remission treatment based on the~     improvement in prognostic characterization of AML and the implementation of novel~     transplantation techniques.~   "
102398|NCT01716780|"~     This study is looking at treating cancer pain in head and neck cancer. Patients are asked in~     outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with~     a pain score of 4 and above are randomised into the study.~      Patients are allocated to continue with their current care (control group) or to be reviewed~     by the pain/palliative care team (intervention group). At baseline questionnaires are~     completed on level of pain, type of pain, quality of life and anxiety/depression.~     Information is also collected on the analgesia they've used in the past month and basic~     health economics (GP/hospital visits related to pain management and treatment).~      Follow up in the trial is for 3 months and consists of questionnaires as above and further~     collection of information on analgesic usage and health economics.~   "
102399|NCT01716767|"~     Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the~     musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here~     the investigators examine - in a double-blind randomized controlled cross-over trial - the~     acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain~     symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.~   "
102400|NCT01716754|"~     This study will assess the effect on asthma control of different dose levels and regimens of~     QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2~     agonist medication. Safety will also be assessed. Comparison will be to placebo and~     omalizumab. Information from this study will inform the design of future studies.~   "
102401|NCT01716741|"~     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all~     patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to~     identify groups of patient who are of high clinical suspicion for undiagnosed Gaucher~     disease. A group of potential participants will be identified through the PDR. Detailed~     records will be requested to further narrow to ideal participants based upon previously~     existing diagnoses and symptoms. Participants will be invited to partake in the study via a~     letter from their Partners care provider with supporting study details. Study participants~     will be evaluated in a one-time visit. A complete family and medical history will be~     collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All~     participants will be notified of their disease status via letter and phone call from the~     study staff. If the study participant is diagnosed with GD through this evaluation, proper~     follow-up recommendations and referrals will be provided. Our intent is to determine if~     existing patient data can successfully be utilized to aid in the identification of patients~     with rare genetic disease.~   "
102413|NCT01716585|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and~     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as~     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected~     treatment-naïve adults.~   "
102414|NCT01716572|"~     The researchers will investigate whether erythromycin infusion is better than gastric lavage~     prior to emergency endoscopy to improve the quality of examination in patients with upper~     gastrointestinal bleeding.~   "
102402|NCT01716728|"~     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all~     patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to~     identify groups of patient who are of high clinical suspicion for undiagnosed lysosomal acid~     lipase deficiency. A group of potential participants will be identified through the PDR.~     Detailed records will be requested to further narrow to ideal participants based upon~     previously existing diagnoses and symptoms. Participants will be invited to partake in the~     study via a letter from their Partners care provider with supporting study details. Study~     participants will be evaluated in a one-time visit. A complete family and medical history~     will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn.~     All participants will be notified of their disease status via letter and phone call from the~     study staff. If the study participant is diagnosed with LALD through this evaluation, proper~     follow-up recommendations and referrals will be provided. Our intent is to determine if~     existing patient data can successfully be utilized to aid in the identification of patients~     with rare genetic disease.~   "
102403|NCT01716715|"~     This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel~     works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube,~     or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as paclitaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. It is not yet known whether~     cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent~     or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.~   "
102404|NCT01716702|"~     Background: Prostate cancer (PCa) is the most common cancer for men. When treated early~     enough it is typically curable. However, common treatments, such as radical prostatectomy~     and radiation therapy, often result in significant negative outcomes with regard to sexual,~     psychological and social function. Both men and partners have identified the need for more~     information and support to address sexual health concerns after treatment. However, very few~     sexual rehabilitation interventions have been developed and rigorously assessed.~      Purpose: The investigators propose to develop and pilot test a new program to meet the~     sexual health needs of men with PCa and their partners using an online, professionally~     facilitated education/support program. The goals of the program are to improve sexual~     function, intimacy and mood for men and their partners after treatment for localized PCa.~     The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian~     platform for professionally facilitated support group programs.~      What Participants Can Expect: A total of 24 men and their female partners (48 individuals)~     will be recruited and assigned to one of two groups. The first group will participate in the~     program immediately; the second group will be offered the program after a 5-month delay. The~     decision about which group will start immediately and which later will be made randomly (by~     chance). Both groups of men and partners will be asked to complete questionnaires three~     times and, at the end of the program, to provide the researchers feedback about how~     satisfied they were with the program, the changes they made, things they learned as a result~     of the program, and suggestions for improving the program. Participants must have access to~     a computer, an Internet connection and be willing to attend online, chat room meetings each~     week for 1.5 hours for 6 weeks.~      Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult~     to access. The investigators hope to improve access to sexual health care through this~     study.~   "
102405|NCT01716689|"~     This is a single arm phase II clinical study to evaluate the efficacy and safety of~     metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced~     sarcomas.~   "
102406|NCT01716676|"~     In recent years medicine has been enhanced by the incorporation of technological innovations~     from areas as diverse as cell biology, biochemistry, genetics, biophysics and~     bioengineering. One of the few exceptions in this rapid process of implementing~     technological advances occurs in clinical medicine, where its penetration is much less~     effective than in other scientific and professional fields, or even in everyday life.~     Attempts to tackle this problem have given rise to various initiatives in the US and Europe,~     including Spain.~      There is a surprising paucity of telemedicine systems in clinical practice, especially with~     respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea~     (OSA), where protocols are urgently needed to alleviate this healthcare problem represented~     by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In~     others words, the growing awareness of sleep disorders, especially OSA, has not been~     accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these~     diseases.~      CPAP therapy compliance is not always appropriate. Helping patients during the first two~     months usually determines compliance. Therefore, the development of strategies to support~     the patient during the first weeks is essential. However, this collides with reality,~     where it is difficult to properly care all patients because of congested sleep units. It is~     therefore necessary to implement new and imaginative control schemes especially at the~     beginning of the treatment. Patients' follow-up performed by telemedicine technology is an~     option that aims to substitute the face-to-face visits or at least reduce them considerably.~     In a future context, the idea is that the professional in charge of CPAP patients monitoring~     has on his/her agenda face-to-face visits and televisits (at distance) and information which~     patient will provide through online questionnaires with a certain frequency.~      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA~     patients monitored by telemedicine techniques (website and televisits) is similar to that~     achieved by standard monitoring but more cost-effective. The study design is a multicenter~     randomized trial with parallel groups and blind final evaluation after CPAP treatment~     following two different strategies: one through conventional monitoring in the hospital~     (face-to-face visiting) and another by telemedicine monitoring (non-contact visiting and~     website).~   "
102407|NCT01716663|"~     This is a prospective, multicenter, non-randomized observational study of subjects 18 years~     and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal~     Atrial Fibrillation (AF).~   "
102408|NCT01716650|"~     To assess the pain scores before and after saphenous nerve block placement in patients with~     degenerative joint disease of the ankle~   "
102409|NCT01716637|"~     While the cause of AD is still unknown, evidence suggests it develops because of a complex~     series of events in the brain that occur over time. Two pathways possibly involved in~     development of AD are inflammation and oxidative stress. Scientists have linked chronic~     inflammatory events in the brain with the onset and progression of Alzheimer's Disease.~     Oxidative stress has also been implicated in the pathogenesis of a number of neurological~     disorders including Alzheimer's Disease.~      Etanercept (Enbrel®) is an approved drug for the treatment of several forms of arthritis~     when administered by injection. Some research suggests that etanercept, when administered by~     injection into the tissues close to the spinal column (perispinally), may modulate certain~     aspects of the immune system and provide some beneficial effect for people with Alzheimer's~     disease. Studies suggest that supplementation with specific nutrients may also have a~     positive effect in support of cognitive function.~      This study will be conducted at one research office with volunteers who have been diagnosed~     with mild to moderate Alzheimer's disease. Each qualifying participant will be randomly~     assigned to receive an etanercept injection plus nutritional supplements for 6 weeks~     followed by a crossover and a washout period of 4 weeks to then receiving nutritional~     supplements alone or vice versa for another 6 weeks.~      Participants will undergo blood and urine safety assessments at the beginning and end of~     each 6 week treatment period. During 4 of the 6 weekly visits in the treatment period with~     the injections, you will complete the cognitive tests twice; once before and once 2 hours~     after the injection. During 4 of the 6 weekly visits in the treatment period without the~     injections, you will also complete the cognitive tests twice; once before and once 2 hours~     after being asked to lie down onto a table for 5 minutes. You will be allowed to continue~     your standard of care for Alzheimer's disease throughout your participation in the study.~   "
102410|NCT01716624|"~     The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy~     for children with neurogenic bladder due to spina bifida and compare results with standard~     oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain~     or improve bladder storage function without side effects associated with oxybutynin use.~   "
102420|NCT01716494|"~     The overall goal of this proposal is to better understand the basis of airway remodeling in~     severe asthma and how remodeling changes over time. The investigators propose to study a~     well-characterized cohort of adult and pediatric subjects with severe asthma using a~     multidisciplinary state-of-the-art approach.~   "
102421|NCT01716481|"~     The objectives of this study was to test hypothesis that ischemic stroke patients having~     moderate to severe persistent neurologic deficit will have better outcomes with intravenous~     transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum~     that is obtained at acute phase of stroke than patients receiving standard treatment.~   "
102422|NCT01716468|"~     The purpose of this study is to determine the safety and tolerability of a modified low~     carbohydrate diet, determine if quality of life is improved and to determine if the diet has~     any effect on tumor growth (size or spread) and or to determine if there is any effect on~     progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.~   "
102423|NCT01716455|"~     Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of~     chronic iron overload in patients with transfusion-dependent hereditary and acquired~     anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184~     (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and~     elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal~     disease (ESRD) degrees of impaired renal function. The results of this study will~     characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult~     subjects with various degrees of renal impairment, and these data will be compared to~     healthy adult and elderly subjects.~   "
102424|NCT01716442|"~     Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS)~     on the basis of favorable clinical observations. Yet the long-term effect on maintaining~     remission or the likelihood of becoming rituximab-dependent is unclear and the information~     on the safety profile of rituximab is limited. This trial was designed to investigate the~     safety and efficacy of Rituximab in children with refractory NS.~   "
102425|NCT01716429|"~     This study will be a 6-month intervention that is examining how different dietary approached~     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting~     pregnancy, particularly by measuring changes in weight. Participants will be randomly~     assigned to following one of two dietary approaches for weight loss: 1) a low-calorie~     approach to weight loss (reducing caloric intake by approximately 500 calories per day) or~     2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any~     animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods,~     such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be~     low-glycemic index, which means the consumer will be asked to favor foods that don't cause a~     quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast).~     Participants will receive counseling and supporting materials on the dietary approach the~     participants are assigned to follow. Both diets are safe and have shown to be effective ways~     to assist with achieving a healthy weight. The investigators hypothesize that both groups~     will see improvements in weight and fertility with possible greater improvements seen among~     participants in the vegan group.~   "
102426|NCT01716416|"~     This phase I trial studies the side effects and best dose of pazopanib hydrochloride~     (pazopanib) when given together with cetuximab in treating patients with incurable recurrent~     or metastatic head and neck cancer. Pazopanib may stop the growth of cancer by blocking~     blood flow to the tumor. Pazopanib may also block some of the enzymes needed for cell~     growth. Cetuximab is a monoclonal antibody that blocks the ability of some tumor cells to~     grow and spread. Giving pazopanib with cetuximab may provide a more effective treatment for~     patients with advanced head and neck cancer.~   "
102427|NCT01716403|"~     The risk of severe anemia is increased in patients treated by tri-therapy compared to~     patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain~     unexplored but could also depend on the global exposure of telaprevir. The trough~     concentration or AUC of telaprevir could therefore be a predictive factor of the onset of~     anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of~     telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve~     tolerance and SVR.~   "
102428|NCT01716390|"~     To determine the effect of investigational products on serum LDL cholesterol.~   "
102429|NCT01716377|"~     Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine~     administration in reducing acute and chronic musculoskeletal pain in individuals presenting~     to the ED for evaluation after motor vehicle collision.~      Participants: Participants will consist of 60 patients between the ages of 18-50 who present~     to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain~     score > 6 will be screened for further eligibility.~      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60~     high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of~     venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed~     during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6~     weeks, 4 months, and 6 months post-MVC.~   "
102442|NCT01716208|"~     It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have~     low levels of complement. Several drugs have been approved by the Food and Drug~     Administration (FDA) for use in this cancer. However, these drugs are often used as~     combination therapies which means two or more drugs are part of the treatment. Many people,~     especially elderly patients, cannot put up with the use of multiple drugs because of the~     side effects.~      The main purpose of this study is to see if patients respond to therapy with human plasma~     (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to~     find out if this therapy will increase chances of getting rid of leukemia. This study will~     also look at the levels of complement in your blood. The levels of complement may allow~     better understanding of whether increasing the levels of complement by giving FFP may help~     control leukemia.~   "
102443|NCT01716195|"~     The purpose of this study is to determine whether human papillomavirus (HPV)-positive head~     and neck cancer can be treated with a less aggressive regimen of radiation therapy and~     chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy~     (carboplatin/paclitaxel).~   "
126414|NCT01401062|"~     The purpose of this study is to test safety of combining fresolimumab and local radiotherapy~     and to see if the combination can achieve tumor regression.~   "
102430|NCT01716364|"~     Patients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not~     cured with conventional therapy and new approaches are needed. For the last 15 years we have~     investigated the potential of using a patient's own T cells (a type of white blood cell~     [WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell~     culture and animal models of AML and MM. Over the last 5 years we have been preparing to~     treat patients as part of a Phase I (first in human) clinical trial.~      The trial treatment involves collecting the patient's own WBCs from the blood by a standard~     well established and safe process called apheresis. The cells are then cultured in a~     specialized laboratory (under Good Manufacturing Practice conditions, similar to standards~     under which pharmaceuticals are produced) over 12 days to convert the cells to specialized~     tumor-attacking T cells. Early in that culture process the cells are exposed to a virus~     (that is modified so that it cannot infect or replicate outside the special culture~     conditions) that contains a special gene. Via the virus, this gene inserts into the~     patient's T cells in culture and gets incorporated into the T cell's genetic machinery. As~     the T cells replicate, the new gene produces a protein receptor that becomes part of the~     patient's T cells. This protein receptor on the T cells has the capacity to specifically~     recognize and bind to a protein on the leukemia or myeloma cells called the Lewis Y~     antigen.~      After the modified T cells are infused into the patient, they home into the bone marrow~     (this tracking is monitored by special radiological techniques) where the new protein~     receptor on the T cell surface can recognize and bind to the cancer cells (which express~     Lewis Y). Once bound onto the cancer cells, the T cells get activated and subsequently~     replicate and kill the cancer cells. The novelty of this approach is that the T-cells will~     only kill cells that have the Lewis Y on their surface - the cancer cells. Moreover, because~     there are few normal cells in a person's body that carry Lewis Y, this treatment is likely~     to only have minor side effects.~      This gene therapy trial is unique and although the primary purpose is to test the safety of~     this approach, patients will be monitored closely for anti-tumor responses. As the trial~     progresses, the dose of T cells infused will increase, in the hope that this will result in~     a better and stronger immune response to the leukemia or myeloma.~   "
102431|NCT01716351|"~     Psychosocial risks are significant in the management of patients with cardiovascular disease~     and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled,~     clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly~     reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of~     life in ICD patients. The specialized, real-time data, collected by the device provides a~     unique look at the electrophysiological parameters of each patient's heart.~   "
102432|NCT01716338|"~     Glyburide is a medication that has been safely used for several decades to treat non-insulin~     dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at~     the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically~     and cognitively. The investigators are hopeful that the results of this study will provide~     the necessary foundation to evaluate this medication's use on a larger scale to determine~     the feasibility of using glyburide in soldiers either prophylactically or for the treatment~     of brain injury.~   "
102433|NCT01716325|"~     The purpose of the study is to establish and clinically evaluate a new approach to treating~     obesity by using information and communication technologies (ICT). A mobile environment and~     organizational interventions to improve the process of an integrated treatment of people~     with obesity will be identified, developed, introduced and clinically evaluated.~   "
102434|NCT01716312|"~     Background:~        -  Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the~          body's immune system mistakenly attacks healthy tissue resulting in inflammation and~          tissue damage. SLE can involve almost any organ and its symptoms can range in severity~          from mild to life-threatening; symptoms also vary from person to person. Current~          treatments for lupus are not effective for some people. Medications used to treat lupus~          can have serious side effects.~        -  Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to~          prevent allergic reactions by reducing some antibodies in the blood. These antibodies~          are also present in some people with Lupus. Researchers want to see if omalizumab is a~          safe and effective treatment for people with Lupus.~      Objectives:~      - To test the safety of omalizumab for people with lupus.~      Eligibility:~      - Individuals at least 18 years of age who have moderately active Lupus even with standard~     treatments.~      Design:~        -  Subject screening will take place at the NIH Clinical Center and will include a medical~          history, a physical exam, blood and urine laboratory tests, an assessment of Lupus~          disease activity. Some participants may require some additional testing. All eligible~          persons who are interested in enrolling will be asked to come back to the NIH within 2~          weeks to begin the study.~        -  The study will be conducted in three phases, with a total of 15 study visits over 38~          weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits.~          During each visit the participants will be monitored by doing a physical exam,~          assessment of their lupus disease activity, review of any treatment related side~          effects, blood and urine testing.~        -  For the first phase, participants will have infusions (under their skin) of either~          omalizumab or a placebo. They will have an overnight hospital stay for the first~          infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety~          measures are good they will return in 2 weeks and receive the second dose. They will~          then get three more doses every 4 weeks which will be given during outpatient visits to~          the NIH.~        -  In the second phase, which begins at the 16th week of the study, all participants will~          receive omalizumab. This means that subjects who had been getting omalizumab will~          continue receiving it and subjects who had been receiving the placebo will now begin~          getting omalizumab. They will have an overnight hospital stay for this infusion and~          will return in 2 weeks for a safety monitor visit. If subjects safety measures are good~          they will return in 2 weeks and receive the next dose. They will then get three more~          doses every 4 weeks which will be given during outpatient visits to the NIH.~        -  The third phase will be a final series of visits which will take place at week 32 and~          week 36. During these visits subjects will have a physical exam which includes disease~          activity assessment, blood and urine tests. No medication will be given during these~          visits.~        -  All subjects will be given information, instruction and medications for possible~          allergic reactions to omalizumab.~        -  Throughout the study other tests and procedures will be performed as needed.~   "
102435|NCT01716299|"~     The primary objective of the study is to assess whether an improved MSF HIV diagnostic~     algorithm which includes a simple and easy to perform confirmation test has significantly~     better positive predictive value than WHO recommended RDT testing algorithms that do not~     include confirmatory testing.~   "
102436|NCT01716286|"~     The aim of the current study was to investigate the effect of a low fat meal in comparison~     to a low fat meal dosed with the fatfree essence of olive oil.~   "
102437|NCT01716273|"~     How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating~     wounds compared with standard treatment?~   "
102438|NCT01716260|"~     This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for~     Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients~     with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for~     28 days so as to study the efficacy of CQ alone.~      This study will assess whether CQ is still effective against P.vivax or whether there are~     resistant P.vivax strains in Bhutan.~   "
102439|NCT01716247|"~     The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM)~     will be able to detect smaller/earlier breast cancers as well as breast MRI can.~   "
102440|NCT01716234|"~     The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and~     tolerability of oral posaconazole in immunocompromised children with neutropenia or expected~     neutropenia.~   "
102441|NCT01716221|"~     The purpose of this study is to document the clinical effects of bupropion and citalopram in~     a single subject with Friedreich Ataxia.~   "
102444|NCT01716182|"~     This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a~     Multicenter, Randomized, Prospective format. This study compares two spinal fusion~     procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF).~     Enrollment period will be approximately 12-18 months; each Principal Investigator/Study~     Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7~     subject visits to the study center from screening through the final follow-up visit.~   "
102445|NCT01716169|"~     The purpose of this study is to test the effectiveness of Helicoll (a collagen wound~     dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis~     bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.~   "
102446|NCT01716156|"~     This study will compare two different durations of treatment with grazoprevir (MK-5172) in~     combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible~     interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic~     hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination~     therapy.~   "
102447|NCT01716143|"~     The purpose of this study is to determine whether left atrium substrate based ablation plus~     circumferential is effective in the treatment of persistent and long-standing atrial~     fibrillation.~   "
102448|NCT01716130|"~     To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine~     administrators in the United States. Patients completed 2 surveys, one immediately~     post-vaccination and one seven days later, that documented demographics and assessed their~     injection pain, injection anxiety, speed of injection, overall satisfaction, and preference~     for next year's vaccine. Vaccine administrators completed one survey assessing ease of~     vaccine preparation and administration, time required to administer, and safety/risk of~     needle stick injury for patient and administrator.~   "
102449|NCT01716117|"~     This clinical research study is designed to determine safety and effectiveness of the~     Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide~     neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall~     of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If~     left untreated, the bulge may continue to grow larger and ultimately the vessel may break~     open (rupture), resulting in serious bleeding into or around the brain. The information~     collected from this study will be used to evaluate how well patients do when treated with~     the Surpass System both immediately after treatment of an aneurysm and over a long period of~     time (5 years).~   "
102450|NCT01716104|"~     The purpose of this study is:~        -  To assess safety of Afalaza drug within 12 months in patients with symptoms of benign~          prostatic hyperplasia and risk of progression.~        -  To assess efficiency of Afalaza drug within 12 months in patients with symptoms of~          benign prostatic hyperplasia and risk of progression.~   "
102451|NCT01716091|"~     The investigators hypotheised that irrigating the abdominal cavity with saline at the time~     of cesarean delivery will increase Gastrointestinal System Disfunction without maternal~     infectious morbidity(especially febril morbidity).~   "
102452|NCT01716078|"~     The purpose of this study is to determine the conducting ability of distal extremity nerves~     after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed~     at a more proximal location in the upper extremity.~   "
102453|NCT01716065|"~     The purpose of the study is to determine whether the type of anesthesia during breast cancer~     surgery has any impact on the way a patient's immune system functions for a brief period~     after surgery. If the investigators find that one type of anesthesia versus the other is~     more beneficial to a patient's immune system, then the investigators may use this~     information to design a larger study to exam the effect of anesthesia better.~   "
102454|NCT01716052|"~     The purpose of this study is to determine in a randomized trial whether it is possible to~     decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a~     scripted, supportive text informing patients about mammography.~   "
102455|NCT01716039|"~     Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate~     interaction in subjects with moderately to severely active ulcerative colitis.~   "
102456|NCT01716026|"~     The purpose of this protocol is to determine wether the initial protocol in the treatment of~     subfoveal choroidal neovascularization associated to High Myopia with bevacizumab~     intravitreal injections is more effective when using 3 doses vs using 1 single dose in the~     load period~   "
102457|NCT01716013|"~     To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in~     terms of cosmesis (appearance) of the repaired wound when these devices are used for closure~     of surgical and traumatic wounds .~      To demonstrate safety of BondEase™.~   "
102458|NCT01716000|"~     This study will compare two investigational techniques for measuring how vaginal gels spread~     and coat the vagina. This study will also explore the experiences and opinions of women~     using this vaginal gel. We want to understand how the characteristics of a gel, such as a~     gel's thickness or consistency, affect how the gel spreads and feels in the body. We hope to~     use the information we learn from this study to develop future vaginal gels that could be~     combined with medications and used to slow down or stop the spread of sexually transmitted~     infections.~   "
102459|NCT01715987|"~     Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney~     toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients.~     Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono~     infected Asian patients receiving TDF treatment.~   "
102460|NCT01715974|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     treatment with G-CSF, a growth factor working on stem cells, may improve the pregnancy rate~     and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.~   "
102461|NCT01715961|"~     This clinical trial is a multicentric prospective study to assess the clinical and~     prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell~     lymphoma.~   "
102472|NCT01715818|"~     This randomized, double-blind, placebo-controlled, parallel group, multicenter study will~     evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable~     cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive~     either aleglitazar 150 mcg orally daily or matching placebo.~   "
102473|NCT01715805|"~     The objective of this study is to evaluate the efficacy, safety and tolerability of~     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD~   "
102474|NCT01715792|"~     This study aims to assess the risk of solid organ transplant (SOT) rejection following~     vaccination with Pandemrix™ and/ or seasonal influenza vaccination.~   "
127587|NCT01385527|"~     The purpose of this study is to evaluate whether participation in an Internet-based~     intervention helps improve atopic dermatitis treatment outcomes.~   "
102462|NCT01715948|"~     People with single-sided deafness (SSD) have significant hearing loss in one ear and normal~     or near normal hearing in the other ear. Those living with SSD experience several~     communication difficulties, particularly when listening to speech in the presence of~     background noise. This problem is worse in situations where the noise is on the side of the~     good ear and the speech is on the side of the poor ear.~      The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS)~     hearing aid are two intervention methods designed to improve hearing in people who have~     significant hearing loss in one ear only. The BAHD is a surgically implanted device which~     also includes an external processor; sounds from the poor ear are transmitted to the good~     ear through skull vibrations. The CROS does not involve surgery; instead a hearing aid is~     fitted behind each ear, and the sounds on the side of the poor ear are wirelessly~     transmitted to the good ear.~      The majority of previous studies comparing the BAHD to the CROS have used older CROS models~     with basic technology and a wire along the neck to send sounds from the poor ear to the good~     ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the~     BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on~     speech perception scores when listening to speech in quiet and in noise. The research will~     also investigate participants' reported benefits with each device during everyday~     situations. In order to compare the BAHD and CROS, individuals who already have been~     implanted with a BAHD will be given a trial period with a new wireless digital CROS hearing~     aid.~      The research hypothesis states that the CROS hearing aid will be as equally beneficial or~     greater than the BAHD in improving hearing and participant benefit. If the findings support~     the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better~     alternative, more individuals with SSD may choose to avoid surgery and decide to receive a~     CROS hearing aid instead.~   "
102463|NCT01715935|"~     Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma~      An open-label, exploratory, single-arm, multicenter trial.~      Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest~     period prior to nephrectomy.~      Two to four weeks after surgery, everolimus will be reintroduced only for metastatic~     patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or~     other stopping rules are met.~   "
102464|NCT01715922|"~     The aim of the trial is to demonstrate that in a sub-Saharan African setting, the~     association of:~        1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100~          mg/kg/j) as induction therapy~        2. lumbar punctures to control intracranial pressure~      can decrease mortality rate below 35% at 10 weeks.~      This is a non-randomized open label pilot study, with standardized management of~     cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients~     will be enrolled.~   "
102465|NCT01715909|"~     This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the~     pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised~     children, less than (<) 13 years of age, with confirmed influenza infection. Participants~     will be randomized to receive either the standard dose or triple dose of oseltamivir orally~     daily for a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized~     to the standard dose arm only.~   "
102466|NCT01715896|"~     The primary objectives of this study is to explore the efficacy of mavrilimumab compared~     with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe~     active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional~     disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor~     (TNF) agents (excluding golimumab) for efficacy or safety reasons.~   "
102467|NCT01715883|"~     This is a Phase IIA observational nonrandomized pilot investigation to evaluate the safety~     and efficacy of Sodium Nitrite administration for the reduction of PGD in patients~     undergoing lung transplant. The study will enroll 8 subjects, undergoing lung transplant at~     the University of Pittsburgh Medical Center (UPMC).~   "
102468|NCT01715870|"~     The study population will be selected from the Epidemiological study on the prevalence of~     Age related Macular Degeneration in Portugal (Protocol N. CC-01-2009) where retinal~     photographic grading (current gold standard for AMD assessment) was performed to confirm AMD~     diagnostic. This study provides a population-based sample in which precise and contemporary~     information on the frequency of nutritional and lifestyle risk factors will be collected,~     enabling to evaluate whether the separate and/or joint effects of these factors, if found~     significant, are likely to have a major public health impact in terms of AMD.~   "
102469|NCT01715857|"~     Until recently, there was a lack of understanding and consensus among Chinese~     anesthesiologists how they should practice general anesthesia with volatile anesthetics,~     since there was no standard of inhalation practice. In August 2011, the Anesthesiology~     branch of the Chinese Medical Association launched the first version of Chinese Consensus of~     Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the~     practice in China.~      The proposed registry is aimed to evaluate the current inhalation practice one year after~     the Consensus has been released, and related patient outcome. This registry evaluated~     sevoflurane anesthesia, including screening, induction, maintenance, emergence, and~     follow-up within 24 hours post-operation.~   "
102470|NCT01715844|"~     In people who develop asthma after the age of 12 and who are also overweigh, there can be an~     increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when~     compared to normal weight asthmatics. Certain factors are more abundant in the blood of~     individuals who are obese. One such factor is derived from the metabolism of an amino acid~     found in your diet, which is known as L-arginine (Amino acids are most commonly known as the~     building blocks of proteins, the same as the proteins found in food). This factor is called~     asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to~     the health of subjects with asthma. The balance between L-arginine and ADMA plays an~     important role in producing nitric oxide (NO) in the airways. NO is normally produced in the~     lung and plays a major role in maintaining airways open and functioning normally. Our~     research has shown that in subjects with asthma who are overweight and developed asthma~     later in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels.~     We are asking participants in this study to take L-citrulline, which is converted to~     L-arginine by your body, as a supplement for a period of one week. We anticipate that~     L-citrulline will restore NO levels in the airways, by increasing the ratio of L-arginine to~     ADMA~   "
102471|NCT01715831|"~     This multicenter, open-label, single-arm extension study will evaluate the long-term safety~     of tocilizumab (RoActemra/Actemra) in participants with Rheumatoid Arthritis (RA).~     Participants who have completed the MA21488 (NCT00810199) core study and the ML21530~     (NCT00754572) study and who could benefit from the study drug, according to the opinion of~     the investigator, will receive 8 milligram per kilogram (mg/kg) of intravenous (IV)~     tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.~   "
102556|NCT01714713|"~     This study is being conducted to further investigate the safety of prolonged exposure to~     EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic~     who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.~   "
102475|NCT01715779|"~     The objective of this observational study is to characterize long-term (5 years post event)~     clinical outcomes in patients who experienced a thromboembolic event (TEE) during~     participation in the GSK ENABLE clinical trials.~      Patients eligible for the study are patient who experienced a TEE during participation in~     the ENABLE trials. Each included patient will be followed for a period of 5 years from the~     date of their first TEE. Demographic and clinical characteristics will be collected for the~     index date (time of TEE) and every sixth month during the follow-up period, information will~     be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation,~     evaluation for liver transplant and result of evaluation, and liver transplantation.~      All information will collected by medical record review.~   "
102476|NCT01715766|"~     The purpose of the study is to learn about the causes of different types of pain that can~     occur in people who have had an amputation. By gathering information through blood tests,~     photographs, a nerve test, and questionnaires, we hope to de-code how each individual's~     special characteristics affect the type and amount of pain they experience in their~     amputated limb.~   "
102477|NCT01715753|"~     The purpose of the trial is to assess the effects of weight loss on functional status and~     lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight~     reduction intervention. Participants will be randomized into one of two study arms: Weight~     Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%;~     or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight~     loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g~     of high quality protein will be achieved three times a day by subjects in this group,~     predominantly all from animal sources and 60-70% of animal protein from beef. Subject~     criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate~     functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)~   "
102478|NCT01715740|"~     Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at~     some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly~     affect the quality of life. Some patient with chronic urticaria who had poor response to~     antihistamine may need second line medication. In United States, up to 54% chronic~     urticarial patient use oral corticosteroid to control. However, long-term use of oral~     steroids still needs to consider the impact of its side effects. Therefore, patients may~     seek for alternative medicine as an adjuvant therapy.~      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of~     chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical~     trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible~     mechanisms.~   "
102479|NCT01715727|"~     The hypothesis of the study is that the dopaminergic cell death located in the basal ganglia~     of the brain in patients with Parkinson's Disease can be detected by diffusion Magnetic~     Resonance Imaging, specifically by diffusion kurtosis imaging. The preliminary result was~     published in Radiology 2011. The current study proposed to investigate the following issues:~        -  validation of diagnostic sensitivity and specificity~        -  differential diagnosis capability between PD and PD+ syndrome~        -  prognosis capability~      In the first year, patients with Parkinson's disease will be recruited from the outpatient~     clinics of movement disorders in ChangGung memorial hospital Linkou, Taiwan. The diffusion~     parameters in basal ganglia will be compared with a group of healthy controls. In the second~     year, patients with progressive supranuclear palsy and patients with multiple system atrophy~     will be recruited for assessment of differential diagnosis. The patients with Parkinson's~     Disease will return for assessment of disease severity and in the third year, for the~     outcome evaluation.~   "
102480|NCT01715714|"~     Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are~     at risk for postoperative complications after surgery. The StaRT-CABG trial is the first~     large-scale (2,630 patients) that will investigate whether an additional treatment with~     statins (lipid-lowering medication) in high doses before CABG surgery can reduce the~     incidence of major post-surgery complications including death, myocardial infarction and~     stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in~     Germany and is expected to provide relevant clinical data on the efficacy of this novel~     treatment in order to optimize the care for all patients undergoing CABG.~   "
102481|NCT01715701|"~     This study is designed to assess:~        -  The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to~          intercostal nerve blockade performed at the end of surgery on the intensity of~          postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as~          their primary analgesic modality.~        -  The incidence of chronic pain at 6 months following video-assisted thoracic surgery.~        -  The impact of preoperative multilevel paravertebral nerve blockade on patients' quality~          of life at 6 months following surgery compared to intercostal nerve blockade and to a~          control group using PCA alone.~      Hypothesis:~        1. The basic hypothesis of this study is that preoperative thoracic multilevel~          paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the~          end of surgery will provide superior postoperative analgesia and lower opioid~          consumption compared to PCA alone during the first 24 hours following surgery.~        2. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence~          of chronic pain at 6 months following surgery.~        3. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel~          intercostal nerve blockade performed at the end of surgery will shorten the length of~          stay in the intermediate intensive care unit and shorten the hospital stay.~        4. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel~          intercostal nerve blockade performed at the end of surgery will reduce postoperative~          pulmonary complications.~   "
102482|NCT01715688|"~     This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with~     alkalinized lidocaine on the:~        -  incidence of coughing during emergence of general anesthesia~        -  time needed for emergence following a desflurane-based anesthesia~        -  incidence of sore throat after extubation.~      The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with~     alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control~     group following a desflurane-based anesthesia.~   "
102483|NCT01715675|"~     Rationale: Plant stanols are well known for their effects on lowering intestinal cholesterol~     absorption ultimately resulting in 10-15% reduced serum LDL cholesterol concentrations in~     humans. In addition we have also shown that serum triacylglycerol (TG) concentrations may be~     lowered in subjects with elevated baseline concentrations. Till now, there is little~     evidence for plant stanol effects other than improving lipid profiles. However, we have very~     recently found strong indications in ex vivo models using isolated human peripheral~     mononuclear blood cells (PBMCs) from healthy volunteers that plant stanols have the capacity~     to improve immune function. More into detail, plant stanols shifted the differentiation of~     naive T-cells into the Th1 direction by activating a specific receptor present on the~     Antigen presenting cells (APCs) and T-cells. This effect might ultimately be helpful in~     situations in which the Th1/Th2 cell balance is disturbed into a Th2 over-responsiveness. By~     activating the Th1 response, the disturbed balance may be restored. This is for example a~     possibility in the treatment or prevention of asthma, food allergies or HIV in susceptible~     subjects. In addition, very recently (MEC 08-3-051) in a pilot study we also showed these ex~     vivo Th1 stimulating effects of plant stanols specifically in PBMCs isolated from asthma~     patients, as said, a condition characterized by a Th2 dominant immune response.~      Objective: The major research objective is to prove that the consumption of plant stanol~     ester enriched yogurts can improve immune function in vivo in asthma patients.~      Study design: A double-blind randomized placebo-controlled human intervention study in which~     90 patients with clinically proven asthma will participate: 45 in the intervention group~     receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt~     without added plant stanols. At the end of the run-in period as well as at the end of the~     experimental period blood will be sampled to isolate PBMCs. These cells are used to evaluate~     effects on cytokine production, phagocytic capacity of neutrophils, and the activity of NK~     cells. In addition, the golden standard to show improvements in immune function is by~     showing an elevated Immunoglobulin response to a vaccine. Therefore, during the experimental~     period all subjects receive a vaccination against Hepatitis A Virus. After 1, 2, 3, and 4~     weeks blood will be sampled to monitor specific immunoglobulin titers to HAV.~      Study population: 90 people with clinically proven asthma, who are not carrier of hepatitis~     A, B or C and have not been vaccinated against hepatitis A in the past. Also, these~     participants do not have any other immune-related pathology Main study parameters/endpoints:~     primary: Specific anti-HAV antibody titers after vaccination; secondary: Phagocytic capacity~     of neutrophils; NK-cell activity; Th1 and Th2 cytokine production profiles by PHA stimulated~     PMBCs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the study, 9 blood samples (each 20 or 50 mL) will be taken. Total time~     investment for the subjects will be 160 min. Occasionally, a heamatoma or bruise can occur~     during venipuncture. After the vaccination a heamatoma or a sore arm can occur. These side~     effects should disappear within 4-5 days. Other common side effects related to the~     vaccination are headache, loss of appetite, and fatigue, which usually will disappear within~     24 hours.~      The results of this study will show whether consumption of plant stanol enriched yogurts is~     able to restore the disturbed th1/Th2 balance in asthma patients. Ultimately, this is~     expected to reduce asthmatic exacerbations, as the Th2 dominant immune response seems causal~     to asthmatic symptoms, however these clinical improvements are not verified in this~     relatively short term intervention study.~   "
129739|NCT01357239|"~     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective~     in treating the behavioral symptoms of Fragile X Syndrome.~   "
102484|NCT01715662|"~     This is a pilot randomized controlled trial to assess the feasibility of a home-based~     Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a~     lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee~     amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will~     receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming~     technology. The control arm will receive cognitive computer games and exercises using Wii~     Big Brain Academy Degree program. Both groups will receive the intervention for 40-minute~     sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of~     in-clinic group (n=3) training and individualized in-home training. Outcome measurements~     will be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after~     the end of treatment.~      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical~     hypothesis is that participants in the Wii.n.Walk intervention group will experience an~     improvement in walking capacity compared to the control group. The secondary clinical~     hypothesis is that participants in the Wii.n.Walk group will experience an improvement in~     balance confidence, physical activity, number of steps taken per day, walking while talking,~     lower limb functioning, and locomotor capabilities.~   "
102485|NCT01715649|"~     Telehealth remote patient monitoring is a means of using communications technology - such as~     telephones, computers, and the Internet - to connect patients remotely with their healthcare~     team from their homes. The investigators hope to learn more about improving healthy~     behaviors and blood glucose among persons with diabetes using telehealth remote patient~     monitoring technology to connect directly with nurse care coordinators.~      The purpose of this study is to evaluate a process for improving blood glucose and healthy~     behaviors among people with type 2 diabetes using telehealth remote patient monitoring~     technology with nurse care coordinators. Some of the people in this study will work with a~     nurse care coordinator who will review your blood glucose weekly and call you at home every~     month for 3 months, while some of the people in this study will simply receive their normal~     care. At the end of the study, every participant will be asked questions about how they feel~     about their health care.~   "
102486|NCT01715636|"~     This study aims to describe the safety, tolerability and adherence to the coformulated~     anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex~     with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical~     intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive~     NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.~     Three or two anti-HIV drugs are administered for 28-days depending on the severity of the~     the assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.~     Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since~     2006.~      This is a multi site, prospective, open-label, non-randomised trial. Participants will be~     MSM who present at the various recruitment sites requesting NPEP. Initially, 50 eligible~     participants will be assigned to receive eviplera 25mg once daily taken with food for~     28-days according to established Australian guidelines for the use of 3-drug NPEP. There~     will be 7 visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim~     analysis demonstrates acceptable safety, it is proposed to seek ethics approval to increase~     the samples size to 100 patients to gain more accurate information on regimen completion~     rate and on-drug adherence.~      The primary study objectives are:~        1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF~        2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF~        3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using~          FTC-RPV-TDF~   "
102487|NCT01715623|"~     The investigators previously showed that both antibody class switching (from IgM to IgG, IgA~     or IgE) and antibody secretion are controlled by a polymorphic 3' regulatory region (3'RR)~     of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on~     the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B~     allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk~     factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since~     the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its~     genetic polymorphism might influence not only the occurrence of immunopathologic processes~     involving class-switched antibody deregulated production but also the severity of such~     diseases or the time course of their progression. We wish to focus on two conditions~     involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities,~     and on the other hand a disease involving pathogenic IgA and for which the prognosis is~     currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura~     (HSP).~      Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to~     focus on homogeneous groups of patients and we thus wish to concentrate on two groups of~     patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms~     and severe food allergies related to peanut allergens sensitization. These groups will be~     built by considering multiple clinical criteria (clinical history, severity of the~     manifestations, positive skin tests, and positive oral provocation tests for peanut~     allergens…) and biological criteria authenticating the mechanisms of the disease (high~     specific serum IgE, demonstration of specific basophil activation by the allergen…).~      In parallel to the study in patients, we will include a large cohort of healthy controls~     (400 individuals), in order to be able to decipher whether correlations can be seen between:~        -  IgH 3'RR genotypes~        -  The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which~          are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory)~          and IgE (highly pro-inflammatory and responsible for hypersensitivities)~        -  IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as~          correlated with varying levels of IgG and IgE production in normal individuals).~   "
102488|NCT01715610|"~     This study aims to look at the necessity for prescribing antibiotics post-drainage of~     peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with~     two arms - patients receiving placebo versus those receiving a seven day course of oral~     Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is~     resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will~     be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be~     phoned after 7 days to assess if their symptoms have resolved via an over the phone~     questionnaire. Anaerobic and aerobic cultures will be obtained.~   "
102489|NCT01715597|"~     The investigators want to know whether the intravenous ascorbic acid would reduce the blood~     loss during laparoscopic myoma surgery. The investigators randomized patients into~     intravenous ascorbic acid group and placebo group and examined the blood loss in both~     groups.~   "
102490|NCT01715584|"~     It is controversial whether or not patients whose Renin Angiotensin System is blocked for~     the treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.~      The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System~     causes altered dose response under general anaesthesia in a dose dependant manner. The~     investigators wish to look for altered responses across the usual anaesthetic dosing range~     as measured by blood pressure and heart responses.~   "
102491|NCT01715571|"~     The primary objective of this study is to assess the safety, acceptability, and satisfaction~     of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary~     objective is to demonstrate subjective physiological response (erection, rigidity, orgasm)~     after four weeks of frequent device use and the satisfaction of penile erection and sexual~     intercourse with partner.~   "
102492|NCT01715558|"~     The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by~     RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes~     in bradycardia target population.~   "
102493|NCT01715545|"~     The purpose of this study is to explore a method to identify the viability of day-3 poor~     quality embryos~   "
102494|NCT01715532|"~     Primary Outcome Measures:~      - To compare the progression free survival(PFS) in patients with unresectable hepatocellular~     carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without~     Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3~     family.~      Secondary Outcome Measures:~      - To compare the overall survival(OS), objective response rate(ORR), and side effects of~     treating HCC with TACE plus Huachansu or TACE alone.~      Exploratory Outcome Measures:~      - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase~     α3 family.~   "
102495|NCT01715519|"~     The purpose of this study is to determine whether vilazodone is effective in the treatmen of~     Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.~   "
102496|NCT01715506|"~     This is a single-blinded controlled cluster-randomized intervention trial recruiting staff~     from 24 NHs in three counties in the region of Western Norway, randomly selected from the~     total NH population in the region. A cluster is defined as a working ward of a larger NH,~     without shared facilities or staff. The 24 NHs are randomized into two groups, for~     intervention (12) and control (12). One department in each is selected for intervention and~     data collection will take place also in one department in each of the NHs in the control~     group. Hence the analyzed units (clusters) are NH departments. The educational intervention~     (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly~     guidance for six months. A seven-month educational intervention will be performed, and due~     to ethical issues the control group will receive the same intervention after the second~     follow-up. Effects will be measured on resident and care staff level at baseline before~     randomization, after the intervention (7 months) and at follow-up (7 months later) of the~     intervention group.~   "
102497|NCT01715493|"~     The aim of this study was to assess the effectiveness for small airway inflammation of 4~     weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.~   "
102498|NCT01715480|"~     The overall purpose of this study is to obtain a better understanding of the biological~     response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have~     been put through a blending process. This study will use commercially available fresh~     broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This~     product can also be purchased at some local grocery stores in the produce section. It is~     believed that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the~     regulation of defense against oxidative stress. The detrimental accelerated breakdown of~     sickle cell disease (SCD) red blood cells (SS RBC) is partially due to reduced~     anti-oxidative capacity. Previous analysis of SS RBC microRNAs revealed that a reduced level~     of NRF2, the master regulator of anti-oxidative stress capacity, contributes to reduced~     resistance to oxidative stress and increased hemolysis; NRF2 also induces fetal hemoglobin~     (HbF), which is known to prevent SS RBC sickling.~      First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out~     how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF~     expression, and microRNA expression of red cells.~      Second, a pilot clinical trial will be conducted to determine the safety and physiological~     effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb~     SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for~     changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood~     cells.~   "
102499|NCT01715467|"~     This observational study will prospectively collect data on treatment options,~     patient/investigator satisfaction, requirement for retreatment or additional treatment, and~     long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle~     aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide~     additional health economics and utilization data.~   "
102500|NCT01715441|"~     The aim of this multicenter randomized phase II trial is to determine the efficacy of~     sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib~     monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure~     of all active drugs known to be effective.~   "
102501|NCT01715428|"~     Incretin-based therapies have shown significant effects beyond those on glucose metabolism.~     We aim in the present study to evaluate the effects of liraglutide on several~     cardio-metabolic risk markers.~   "
102502|NCT01715415|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and~     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as~     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected~     treatment-experienced adults.~   "
102503|NCT01715402|"~     The aim of this study is to reduce the length of stay after liver surgery by taking account~     of objective quantitative clinical variables, subjective qualitative clinical variables and~     non clinical variables.~   "
102504|NCT01715389|"~     This pilot intervention study will test the feasibility and acceptability and explore the~     outcomes of a primary care-based shared decision making (SDM) electronic medical record~     (EMR)-based portal that provides education, elicits and tracks patients/families' treatment~     concerns and goals, assesses symptoms and asthma control over time, and provides decision~     support to clinicians and families.~   "
102505|NCT01715376|"~     Compared with standardized western medical drug therapy, this study is mainly about whether~     the combination of standardized western medical drug therapy and Chinese medical continued~     treatment, can further decrease the rate of cardiovascular events for stable angina patients~     and change the condition of angina.~   "
102506|NCT01715363|"~     The purpose of this study is to analyze the clinical tolerance of immediate preoperative~     chemotherapy in terms of toxicity and perioperative morbidity and mortality~   "
102507|NCT01715350|"~     The investigators intend to perform exploratory evaluation of the treatment effectiveness~     and safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to~     moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose~     with placebo control for the efficacy and safety to explore the clinically optimal dose of~     PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.~   "
102508|NCT01715337|"~     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy~     in patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to~     show a potential change in muscle fibre composition and in the amount of capillaries in~     quadriceps muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes~     standardised exercise training, e.g. cycling and strength training for major muscle groups.~   "
102509|NCT01715324|"~     In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually~     taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization~     protocols are constantly under review in order to improve the recruitment of the follicles,~     which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the~     ultimate aim of increasing the live birth rate.~      The addition of growth hormone, which is a biological hormone that can be synthetically~     produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been~     suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth~     hormone has been shown, in animal and human studies, to be important in the recruitment of~     follicles.However, to date, only a limited number of clinical studies have been performed in~     order to assess whether the addition of growth hormone can improve the probability of~     pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total~     number of patients analysed in these studies was small it has not been possible to determine~     whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a~     woman is given growth hormone therapy as a supplement during her treatment.~      This goal of this study is to determine the effectiveness of using growth hormone therapy as~     a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization~     protocol.~   "
102510|NCT01715311|"~     This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication~     only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have~     not received maintenance COPD medication for at least 12 months prior to entry (described~     hereafter as maintenance naïve, see inclusion criteria).~   "
102511|NCT01715298|"~     The study serves to determine whether the treatment of patients with stable, symptomatic~     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is~     efficient and safe. The efficacy and safety of the drug will be tested against a placebo~     treatment. The primary criterion to assess efficacy will be the difference between the~     serial lung function measurements of patients who have been treated for 12 weeks with NVA237~     versus those that have received placebo treatment for 12 weeks. A serial lung function~     measurement (FEV1 testing) will be conducted and the area under the curve will be the~     measure for the ability to breathe.~   "
102512|NCT01715285|"~     The purpose of this study is to determine if newly diagnosed (within previous 3 months)~     participants with metastatic (spread of cancer cells from one part of the body to another )~     hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit~     from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation~     therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).~   "
102513|NCT01715272|"~     This study is designed to assess the difference between the performance of a new enema~     (TF037) against Fleet enema in distal bowel cleansing.~   "
102514|NCT01715259|"~     The purpose of this study is to determine the pharmacokinetic (how the drug concentrations~     change over time) profile of abiraterone acetate 1000 mg when administered as a single dose~     in male participants with impaired renal function compared to individuals with normal renal~     function.~   "
102515|NCT01715246|"~     The primary objective of this clinical study is to show that infants fed a standard starter~     infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants~     fed a standard starter infant formula without HMOs.~   "
102516|NCT01715233|"~     To estimate and compare the response rates in patients treated with mDCF based on~     methylation status of CHFR.~   "
102517|NCT01715220|"~     ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from~     suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate~     its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving~     acute pain of suspected biliary tract origin.~      Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during~     ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal~     experience and small case reports. Nitroglycerin effect is a result of the nitric oxide~     component of the medication which acts as a smooth muscle relaxant in vascular, bronchial,~     esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The~     typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently,~     in a metered spray form. In a case series reported by Hassel (1993), positive response times~     ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual~     nitroglycerin is most commonly used for treatment of chest pain related to insufficient~     cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms.~     Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment~     blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This~     study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the~     initial treatment of acute pain from suspected symptomatic cholelithiasis~   "
102527|NCT01715090|"~     The main objective of the study is to determine whether an intensive web-based titration~     system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective~     in improving glycaemic control in patients with diabetes mellitus type 2 using a basal~     insulin, compared to standard care.~   "
102528|NCT01715077|"~     Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3~     weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for~     functional characteristics.~   "
115052|NCT01550198|"~     The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring~     results in an earlier detection of circulatory failure in newborn infants~   "
102518|NCT01715207|"~     Marfan syndrome (MFS) is an inherited disorder of connective tissue with morbidity and~     mortality from aortic dilatation and dissection. The current standard of care is~     beta-blocker (BB) treatment and therapeutic target is heart rate. The degree of aortic~     dilatation and response to BB vary in adults with MFS. However, aortic stiffness is often~     present, and can be a predictor of aortic dilatation and cardiovascular complications.~     Aortic stiffness is a logical therapeutic target in adults with MFS.~      Transforming growth factor beta(TGF-beta) mediates disease pathogenesis in MFS and~     contributes to aortic stiffness. Cross-talk between TGF-beta system and renin-angiotensin~     system (RAS) has been demonstrated. The angiotensin receptor blocker (ARB), losartan,~     inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. In a~     small cohort study, the use of ARB therapy (losartan or irbesartan) significantly slowed the~     rate of progressive aortic dilatation in patients with MFS, after BB therapy had failed to~     prevent aortic root dilatation. In another study, angiotensin converting enzyme inhibitor,~     perindopril, reduced both aortic stiffness and aortic root diameter in patients with MFS~     taking standard BB therapy. Renin inhibitor, aliskiren, has not been studied to reduce~     aortic stiffness and attenuate aortic dilatation in patients with MFS.~      This trial is a randomized, open-label trial of 32 patients with Marfan syndrome, treated~     with 6 months of aliskiren vs. negative controls in patients with MFS under atenolol~     treatment. MRI for aortic pulsed wave velocity (PWV) and distensibility, measurements of~     central BP (CBP) and augmentation index (AIx) will be performed at the beginning and end of~     treatment. A blood drawn for serum markers of TGF-beta, extracellular matrix turnover and~     inflammation will also be performed at 0 and 6 months. We plan to determine whether~     aliskiren decreases aortic stiffness significantly more than negative controls in patients~     with MFS under atenolol treatment.~   "
102519|NCT01715194|"~     We hypothesize that the use of telemedicine combined with support interventions by short~     messages, telephone calls and ambulatory visits to control CPAP treatment during the first~     month improves adherence and reduces unresolved side effects of therapy.~      The primary objective of an OSAS treatment program is to successfully implement indicated~     CPAP in the highest possible proportion of patients in order to lower the proportion of~     untreated OSAS in the population. On an individual basis, it has been shown that a longer~     duration of CPAP use is associated with better outcomes in terms of daytime functioning and~     in the control of metabolic and blood pressure effects of CPAP. For our study, we have~     therefore decided to use 2 co-primary endpoints, taking into account both aspects of~     adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.~     Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.~     We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive~     impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of~     treatment.~   "
102520|NCT01715181|"~     Older adults with Alzheimer's disease and other forms of dementia frequently develop~     challenging neuropsychiatric symptoms (NPS) as a result of their illness.~     Non-pharmacological strategies to manage these symptoms such as music, exercise, and~     participating in pleasant social events have been demonstrated to be safe and effective~     strategies to reduce these behavioral symptoms. Our project, Volunteers Adding Life in~     Dementia (VALID), will design and implement a volunteer-led program to reduce behavioral~     symptoms and improve the quality of life of older adults with dementia who are residing in~     long-term care facilities.~   "
102521|NCT01715168|"~     The purpose of this study is to find the answers to the following research question(s):~      1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same~     way in the body as the approved drug?~      ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to~     prove. All people who participate in this study will receive the research study medication~     (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).~      The study drug being tested in this study works the same as the FDA (government) approved~     drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being~     delivered (given to the patient).~   "
102522|NCT01715155|"~     The purpose of this study is to evaluate the incidence rate of progression of disease, to~     describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in~     the clinical practice in Bulgaria.~   "
102523|NCT01715142|"~     Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease with conventional~     treatments having little impact on disease course. Novel approaches are urgently needed to~     address inherent resistance to the current therapies and to identify new drugs or~     combinations that will have a high chance of success in pancreatic cancer patients. This~     proof-of-concept trial is studying the dynamic tumor response after the administration of~     a short course of gemcitabine and nab-paclitaxel (Abraxane) (a) during a window interval (4~     weeks= 1 cycle) before surgery in resectable pancreatic cancer (cohort 1 = 21 patients) and~     (b) during at least 8 weeks (2 cycles) in locally advanced or metastatic pancreatic cancer~     (cohort 2 = 10 patients).~   "
102524|NCT01715129|"~     Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when~     administered by subcutaneous route.~   "
102525|NCT01715116|"~     The purpose of this study is to determine whether Enhanced device programming to reduce~     therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and~     inappropriate)) is safe for patients implanted with an Implantable~     Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of~     Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii)~     quality of life and distress.~   "
102526|NCT01715103|"~     Current knowledge on mucosa, especially genitals in women, however, remain inadequate,~     especially regarding defense mechanisms and possibilities for a vaccine to induce an active~     immune response at mucosal front door of the most pathogens. Induction of mucosal immune~     response has emerged as a research priority research prophylactic vaccine.The development of~     strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of~     specific and innate immune mechanisms involved in this transmission.~      MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of~     cervicovaginal samples of women infected or not infected with HIV-1. We also assess~     tolerance samples taken by cytobrush and cervicovaginal washings, efficiency and~     reproducibility of the sample by cytobrush and cervicovaginal lavage for transcriptomic~     analysis, measurement of cytokines by Luminex technology, quantification of IgG and IgA. In~     blood we will determine the phenotype of B cells and Tfh cell frequency (T follicular~     helper) and quantification of serum immunoglobulins and will perform a transcriptomic~     analysis of blood cells. Finally we will make correlations with the observed responses at~     the genital mucosa.~      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1~     and 20 healthy women recruited from two centers in France and will include a screening visit~     and two visits M0 and M1 during which mucous and blood samples will be performed.~      The results of the study will capitalize skills in biology mucosa, using powerful tools to~     assess mucosal immunological parameters.~   "
102529|NCT01715064|"~     In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third~     leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with~     feelings of anxiety and depression associated with the disease and associated treatments.~     Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this~     population, but the impact of single bouts of exercise and related psychological or~     neurological changes have never been studied. The primary objective of the proposed study is~     to examine the effect of an acute bout of exercise on neurophysiological and psychological~     indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.~     Participants will be randomly assigned to the intervention (60 min exercise) or control (60~     min of television) and will undergo a brief neurological test (cortical silent period) and~     psychological questionnaires before and after their group assignment.~   "
102530|NCT01715051|"~     The primary objective of this study is to collect pilot data on the efficacy of D-serine,~     relative to placebo, as a cocaine dependence treatment. Secondary objectives include~     evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults~     and 2. tolerability.~   "
102531|NCT01715038|"~     The program effectiveness study aims to assess the effect of a lipid-based nutrition~     supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for~     improving maternal nutritional status during pregnancy and lactation (LNS only), and~     preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.~   "
102532|NCT01715025|"~     Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined~     oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral~     contraceptive for 3 cycles during which they will collect all menstrual blood and send all~     used sanitary protection to the laboratory at the University of Sydney for estimation of~     blood loss by the alkaline haematin method.~      Hypothesis:~      An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling~     HMB in the majority of women without structural pelvic pathology.~      Main outcome:~      The primary efficacy end-point will be the proportion of women with a reduction of menstrual~     blood loss ≥ 50% from baseline.~   "
102533|NCT01715012|"~     This study is a randomized, double blind, placebo controlled trial at a single site. The~     primary objective is to evaluate the safety of ACCS in diabetic subjects with deep burns.~     The secondary objectives of this study are to (1) evaluate efficacy of ACCS in healing burns~     and (2) evaluate whether treatment with ACCS results in less scarring, in subjects with~     diabetes separately comparing healing of the skin graft and the skin graft donor site using~     ACCS plus a burn dressing versus placebo and a burn dressing.~   "
102534|NCT01714999|"~     Following a recent publication by the authors [1], there is no standardized treatment regime~     for the treatment of lacerations of the olecranon or prepatellar bursa, although primary~     bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland.~     The aim of this study is to prospectively follow patients who suffered from an acute~     traumatic laceration of the OB or PB treated, according to the local standards, either by~     bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).~      [1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and~     Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury~     (2012)~   "
102535|NCT01714986|"~     The investigators want to try the psycho educational method The Affect School with Script~     Analysis and the physiotherapeutic mind-body therapy Basal Body Awareness Therapy in~     patients with diabetes, high HbA1c and psychological symptoms, in order to improve~     psychological health- with the primary outcome reduced depression. Secondary outcomes are~     improved improved glycemic control and self-image, and reduced alexithymia and anxiety.~   "
102536|NCT01714973|"~     The objective of this study is to evaluate the safety and efficacy of ACCS in treating~     radiation burns of the skin in patients undergoing treatments for breast cancer and to~     compare ACCS treated burns with those treated with saline placebo controls.~   "
102537|NCT01714960|"~     -  To assess the safety and tolerability of repeat dose topical administration of~          MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and~          glaucoma subjects (stage 2).~        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its~          metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030~          Ophthalmic Solution.~   "
102538|NCT01714947|"~     This is a 2-part, open-label study in 4 to 6 evaluable patients with advanced solid tumors~     or lymphomas. This study is intended to provide a quantitative characterization of the mass~     balance, routes of metabolism, and excretion pathways of alisertib.~   "
102539|NCT01714934|"~     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult~     to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is~     a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were~     described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar~     lavage (BAL) is a routine investigation technique in interstitial lung diseases. The~     presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible~     role for gastric microaspirations in the pathogenesis of the disease.~   "
102540|NCT01714921|"~     Examination of application and efficacy of Smart Shock algorithm in ICD patients~   "
102541|NCT01714908|"~     Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile~     in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating~     mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus~     cis-platin with concurrent radiotherapy.~   "
102553|NCT01714752|"~     Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health~     issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been~     shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures~     elevated only at exercise (normal at rest).~      Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as~     a memory of chronic elevation of filling pressures. We believe that it is possible to~     improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure~     (LVEDP).~   "
102612|NCT01713972|"~     This phase I trial studies the side effects and best dose of dabrafenib and pazopanib~     hydrochloride when given together in treating patients with advanced malignant tumors.~     Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth~   "
102542|NCT01714895|"~     Achieving near-normoglycaemia has been established as the main objective for most patients~     with diabetes. However, it is well known that intensification of treatment is associated~     with an increase in the frequency of hypoglycemia, especially in the context of insulin~     therapy. The burden of hypoglycemia in terms of psychological implications, morbidity and~     even mortality, explains why it has been defined as the main limiting factor to achievement~     of good metabolic control.~      Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in~     hypoglycemia detection/prevention, allowing theoretically for safer intensification of~     therapy in diabetic patients. However, accuracy of CGM devices, especially in the~     hypoglycemic range, raises some concerns. In fact, commercially available CGM devices~     estimate plasma glucose from measurements in the interstitial fluid and not in plasma.~     However, the relationship between plasma and interstitial glucose is not fully understood,~     especially under dynamic conditions, and this may explain the poor CGM performance during~     rapid changes in blood glucose and hypoglycemia.~      In this project, the relationship between plasma and interstitial glucose will be evaluated~     under conditions of normal glucose concentrations and hypoglycemia. Experiments will be~     performed to assess the role, if any, of different plasma insulin concentrations on the~     accuracy of CGM.~      All the information obtained may be relevant to the improvement of the ability of CGM~     devices to detect hypoglycemia and hypoglycemic risk.~   "
102543|NCT01714882|"~     The investigators are trying to determine stress management strategies in couples undergoing~     In Vitro Fertilization (IVF).~   "
102544|NCT01714869|"~     The purpose of this study is to find out how effective and feasible an 8-week course of~     Swedish massage is, for reducing pain and increasing function in adults who are VA~     healthcare users, with osteoarthritis (OA) of the knee.~   "
102545|NCT01714856|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the~     clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in~     each period. After maintaining at least 10 hours of overnight fast Test or Reference product~     was administered orally (as per the randomization schedule) to each subject with about 240~     mL of water at ambient temperature in each period by trained study personnel after consuming~     the whole standardized high fat non-veg breakfast.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples~     were collected at 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00,~     10.50, 11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each~     study period with a washout period of 7 days between the dosing of two periods. Subjects~     were continuously monitored for well being i.e., blood pressure, radial pulse and oral~     temperature before check-in, prior to drug administration and at regular intervals post dose~     in each period. The concentration of Ropinirole in plasma samples obtained from study~     subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical~     analyses were performed on obtained drug concentration data, using appropriate software.~   "
102546|NCT01714843|"~     This study is to investigate the efficacy, safety, and plasma concentration change of~     ASP0456 in patients with constipation-predominant irritable bowel syndrome.~   "
102547|NCT01714830|"~     Chronic pelvic pain (CPP) can affect both sexes and lasts at least for 3 months. CPP in~     women could be due to endometrioses, ovarian cyst, colitis, etc, making the correct~     diagnosis important (1-3). The most prevalent reason for CPP in men is non-bacterial chronic~     prostatitis and in many cases they are considered equivalent to each other (4).~      Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be~     associated with other symptoms such as dysuria, myalgia, arthralgia, chronic fatigue,~     burning sensation in the urethra, abdominal, urine frequency, and pain after ejaculation~     (4-6). Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is devided into two~     groups: III A Type (inflammatory) and III B (Non-inflammatory). The difference between the~     two groups is the presence of leukocytes in prostatic secretions after prostate massage,~     urine and semen (7,8).~      In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent~     because many patients do not consider their symptoms as disease, while 6.3% of people may~     show symptoms (9-11).~      One of the most important challenges in the treatment of chronic prostatitis / chronic~     pelvic pain syndrome, is that its etiology is obscure and it is known as a multi-factorial~     syndrome. The proposed explanations are infection, psychological reasons, autoimmunity and~     neuro-myospasm. Hypotheses about endothelial cells defect and cardio vascular disease have~     also been proposed, upon which the new therapies have been based.~      In duplex mapping study of prostatic vessels in two groups of healthy and chronic~     non-bacterial prostatitis people, it was shown that there was a significant reduction in~     systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis, and~     there was a direct association between pain and blood flow intensity, suggesting chronic~     ischemia as a possible cause for pain (13). Pain in prostate without significant infection~     is the hallmark of chronic prostatitis / chronic pelvic pain syndrome (5). In physical exam,~     prostate or pelvic tenderness may be observed in half of the patients.~      The diagnosis of chronic prostatitis / chronic pelvic pain syndrome is challenging. No~     specific lab test exists for its detection. Prostate specific antigen (PSA) level, which is~     typically increased in acute infection, is usually normal in this condition. The diagnostic~     approach in these patients is based on ruling out other curable causes such as benign~     prostatic hyperplasia or bladder cancer (14-20).~      NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is used to evaluate symptom severity and~     response to treatment in these patients. A reduction of 4-6 points in the score is~     considered significant response to the treatment (21).~      There is no first line treatment for patients of chronic pelvic pain syndrome. The use of~     anti-bacterial, alpha-blockers or anti-inflammatory drug is logical. However, if the patient~     does not respond, further administration is not helpful. In non-responders, combination of~     drugs or other non-medical methods should be considered (23-26).~      As discussed earlier, blood flow reduction, ischemia and disorders in endothelium of vessels~     may cause pain in these patients and methods to improve blow flow may help(13,27). One of~     these methods is extracorporeal shockwave therapy (ESWT) which is typically used for~     tendonitis, acceleration in bone reunion and wound healing, improvement in muscle movements~     through a reduction in passive muscular tonus, increasing muscular range of motion after~     cerebrovascular accident (CVA), treatment of Peyronie's disease and erectile dysfunction~     (28-30).~      Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular~     stiffness, indexes of increased blood flow, vasodilation and reactive vascular hyperemia,~     using Endo-PAT ® 2000-Machine. They showed that endothelial disorder and stiffness along~     with the risk of cardiovascular disorders are increased in CP/CPPS (31).~      The use of ESWT for the treatment of CP/CPPS has been evaluated in a few studies. In a~     double-blind randomized control trial, Zimmermann et al placed 60 patients with chronic~     pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one~     of them in 4 sessions with a frequency of 3000 per session. The treatment group showed~     superior results in terms of symptom improvement(32).~      In another study, Zimmermann et al followed 34 patients with chronic pelvic pain syndrome,~     after one, four and twelve weeks post ESWT in terms of quality of life and pain reduction.~     They showed that this method is useful and without any complications (33).~      Considering the promising results of the cited articles along with the paucity of data in~     this regard we decided to perform a double-blind sham-controlled study to evaluate the~     effectiveness of ESWT in CP/CPPS.~   "
102548|NCT01714817|"~     The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when~     used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)~   "
102549|NCT01714804|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a~     retrospective comparison to a historical patient cohort.~   "
102550|NCT01714791|"~     The purpose of this study is to determine the short and long term effects of osteopathic~     treatment on pulmonary function, pain and quality of life in patients after coronary artery~     bypass graft (CABG) surgery. The study is a randomized controlled trial.~   "
102551|NCT01714778|"~     Electronic cigarettes or e-cigarettes (EC) may have a potential public health benefit as a~     safer alternative to smoking and possibly also as an aid in tobacco dependence treatment.~     However, there are concerns about their safety and whether they can deliver nicotine~     consistently and in doses necessary for such effects.~      To be able to consider the safety of ECs and their potential in harm reduction, data are~     needed comparing the exposure to the potential toxicant, acrolein, in smokers of~     conventional cigarettes, users of EC, and people who use both products at the same time.~      To accurately assess EC nicotine delivery, data are needed from people who use them~     regularly, as there is some evidence of higher and faster nicotine absorption in experienced~     users compared with naïve users who try them once in an artificial laboratory setting.~      This study will provide information on both of these issues. Forty smokers will be given EC~     to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of~     acrolein and nicotine will be measured before and after 4 weeks of EC use.~   "
102552|NCT01714765|"~     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This~     is very difficult to treat and almost all patients will die of their disease within 3 years.~      Sunitinib has become standard therapy for untreated patients with metastatic clear cell~     renal (kidney) cancer. It targets a growth factor known as VEGF which is important in~     treating renal cancer. Although the results with this drug are impressive, patients develop~     resistance to the drug, relapse and die of renal cancer. It is currently standard practice~     is to treat patients with everolimus when resistance to sunitinib occurs; this is associated~     with clear clinical benefit. However the median time to progression with everolimus is 4.9~     months in previously treated patients, therefore further improvement in treating patients is~     required. The optimal way of achieving this is to increase the efficacy of everolimus by~     adding agents which directly target the cause of resistance to sunitinib.~      Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such~     as activation of downstream signalling molecules, cell proliferation and survival. Combining~     dovitinib and everolimus is very attractive.~      This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib~     and everolimus in clear call renal cancer, which can then be taken into a randomised phase~     II study.~      A maximum of 30 patients will be recruited into this multi centre national trial.~      Expansion Cohort:~      The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and~     Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing~     a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib~     300mg), where 2 patients experienced a DLT.~      A total of 7 assessable patients will be recruited during the expansion phase at the MTD~     (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability,~     efficacy, PK and biological end points.~      Assessable patients for the expansion cohort are defined as being on the study for a minimum~     of 6 weeks. Any patients enrolled who are not assessable will be replaced.~   "
102554|NCT01714739|"~     To assess the safety and tolerability and preliminary anti-tumor activity of~     lirilumab/BMS-986015 given in combination with nivolumab/BMS-936558 and to identify dose~     limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in~     subjects with advanced (metastatic and/or unresectable) solid tumors.~   "
102557|NCT01714700|"~     Background: The interactive effects of resistance training and dietary protein on hormonal~     responses in overweight or obese adults are not clear and remain controversial.~     Investigators tested the effect of an isocaloric high-protein diet on body composition,~     ghrelin, and metabolic and hormonal parameters during a 12-week resistance training program~     in untrained overweight healthy young men.~      Methodology: Investigators randomized 18 healthy young males to a standard diet (ST group)~     or an isocaloric high protein diet (HP group). Subjects in both groups participated in a 12~     week-resistance exercise program. Investigators measured body composition, lipid profile,~     homeostatic model assessment of insulin resistance (HOMA-IR) indices, total ghrelin, and~     exercise related hormones at baseline and 12 weeks.~   "
102558|NCT01714687|"~     This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis~     (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.~   "
102559|NCT01714674|"~     Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac~     injury. Previous research has shown that type 2 diabetic patients may experience large~     increments in cTnT levels over the subsequent hours following a single bout of~     moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac~     ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent~     evidence indicates that ingestion of dietary nitrates dramatically increases the~     bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion~     injury.~      The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT~     levels following exercise in type 2 diabetic patients.~   "
102560|NCT01714661|"~     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances~     the cognitive abilities of subjects with Schizophrenia who are also taking stable~     antipsychotic therapy.~   "
102561|NCT01714648|"~     Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for~     IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using~     GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.~   "
102562|NCT01714635|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS~     Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide~     statistically better distance-corrected near visual acuity compared to the monofocal control~     lens. Complication and adverse event rates associated with each Multifocal IOL will be~     within the ISO SPE rate for posterior chamber IOLs.~   "
102563|NCT01714622|"~     Gastric cancer is still one of the most common malignance in Korea. Because of the~     popularity of regular check ups, early detection of gastric cancer has increased,~     consequently, the survival of the patients also has increased. In this reason, the interest~     of outcomes after gastrectomy for gastric cancer move survival only to quality of life of~     these patients.~      Although the definition of metabolic syndrome is various, but it is normally accepted as a~     state that insulin resistance or glucose intolerance combined with hypertension or~     hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the~     treatment is modification of life style, weight loss and medication. However, in most of the~     patients metabolic syndrome is considered not curable disease. Recent studies have shown~     that some bariatric surgery offers not only control the overweight but also metabolic~     syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal~     bypass itself seemed to play an important role to improve metabolic syndrome over just~     decreased weight.~      For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is~     varied subtotal and total gastrectomy according to the location of tumor. Also,~     reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after~     subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation~     for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this~     operation could lead similar effect of bariatric surgery. Already, there have been several~     retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for~     gastric cancer but no prospective study about this subject yet in Korea.~      The purpose of this study is that evaluating the degree of improvement of metabolic syndrome~     after gastrectomy for gastric cancer, and analyze the differences between the type of~     operation.~   "
102564|NCT01714609|"~     Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate)~     liver cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of~     cancer cells and prevents the formation of new blood vessels that would otherwise help the~     cancer spread.~      Studies in experimental animals have shown that sorafenib may also lower portal vein~     pressure (the pressure of the blood passing from the intestine through the liver.) This~     study seeks to determine if sorafenib lowers the blood pressure in liver blood vessels~     (portal vein pressure) in patients with cirrhosis who have high portal vein pressure. The~     study will also obtain information whether sorafenib is safe in this patient population.~      Half of the patients will be given sorafenib and half will be given a placebo (a pill~     without any medicine in it.) This allows a comparison of the reactions of people who take~     sorafenib to those who do not.~   "
102565|NCT01714596|"~     The goal of this study is to evaluate the effect of treatment of post-op wound infection in~     long bones after fracture fixation or joint fusion and either: (Group 1) operative~     debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and~     IV antibiotics for 6 weeks.~      Primary Hypothesis: The rate of treatment failure by one year in Group 1 will be~     non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that~     require surgery >2 weeks after initial debridement, infection recurrence, infection with a~     new pathogen, joint erosion, implant failure, medical problems related to the treatment~     administration which necessitates a switch from one arm to the other.~   "
102566|NCT01714583|"~     The objective of this study is to evaluate the association between positive end-expiratory~     pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with~     acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid~     and Catheter Treatment Trial (FACTT) fluid protocols.~   "
102567|NCT01714570|"~     Neutropenia is very common in patients received hematopoietic stem cell transplantation,~     with median duration of about 14 days. In 2010 update, IDSA recommended~     Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of~     high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after~     hematopoietic stem cell transplantation is very limited.~      The current study will evaluate the efficacy of piperacillin/tazobactam compared with~     imipenem/cilastatin for febrile neutropenia after transplantation.~   "
102611|NCT01713985|"~     Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.~     Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the~     left side. Group B will receive Thermage on the right side of the face and neck and~     Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.~     Study images will be obtained pre-treatment, immediately post-treatment, and at each~     follow-up visit.~   "
102568|NCT01714557|"~     Neutropenia is very common in patients received hematopoietic stem cell transplantation,~     with median duration of about 14 days. Almost all neutropenia will suffer from febrile~     without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in~     neutropenia patients of high risks, while in China, major pathogens possess high resistance~     to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate~     prophylaxis regimen.~      The current study will evaluate the three different regimen:~        1. No prophylaxic antibiotic~        2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas~          activity.~        3. Piperacillin/tazobactam as prophylaxis for neutropenia patients.~          Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas~          antibiotics.~   "
102569|NCT01714544|"~     The purpose of this study is to determine whether Cloderm Cream is effective for topical~     treatment of moderate psoriasis over 28 days.~   "
102570|NCT01714531|"~     The majority of trauma survivors experience prolonged and profound physical and psychosocial~     disability, with up to 50% unable to return to productive employment. The Centers for~     Disease Control (CDC) estimates that more than 1 million of these individuals experience a~     mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.~     Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that~     can lead to vocational and social disability. Long-term cognitive deficits include problems~     with memory and attention, and most importantly executive functioning. Depressive and~     post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with~     cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The~     investigators have found that 55% of trauma patients with mild TBI have profound cognitive~     impairments in executive functioning at one-year survival. Executive functioning is defined~     as a cognitive domain that controls the execution of complex activities of daily living~     essential for purposeful, goal directed behaviors. Deficits in executive functioning are~     the most disabling of all cognitive impairments and affect a person's ability to manage~     effectively in one's personal and professional life. Current literature shows that deficits~     in executive functioning contribute to reduced quality of life, difficulty in returning to~     work, and persistent psychological distress in various medical and surgical populations.~     Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment~     and functional disability in patients with TBI. The overall goal of cognitive rehabilitation~     is not only to improve a person's ability to process and interpret information but to~     increase self-confidence and self-efficacy for coping with emotional distress. Despite~     evidence supporting the use of cognitive rehabilitation, few studies have systematically~     addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators~     propose to conduct a three-group randomized controlled trial to determine the efficacy of~     Goal Management Training (GMT), a structured manual-based intervention targeting executive~     functions that impact a person's ability to carry out daily tasks. The investigators~     hypothesize that telephone-based GMT will improve cognitive functioning, functional status,~     and psychological health in trauma survivors with mild TBI. Emerging research suggests that~     telephone rehabilitation is a feasible and effective alternative (with much broader~     applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited~     access to rehabilitation services due to financial constraints and mobility and geographic~     restrictions that render clinic-based rehabilitation impractical. This clinical trial will~     recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.~     Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2)~     telephone-based attention-control; or (3) usual care. Primary outcomes will include observed~     and self-reported executive functioning and self-reported functional status as measured by a~     battery of standardized and previously validated cognitive tests and instruments, including~     the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and~     the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and~     PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist -~     Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after~     hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital~     discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate~     evidenced-based cognitive strategies to a trauma population that has difficulty returning to~     productive life both inside and outside the home due to profound functional and~     psychological disability. Findings from this study will support future research to improve~     the cognitive, functional and psychological health of patients following major trauma~     through innovative rehabilitation interventions and delivery methods.~   "
102571|NCT01714518|"~     The purpose of this study is to assess efficiency and safety of cryobiopsy compared to~     video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases~     (ILD). To that end, this non-interventional study prospectively collects data from patients~     undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic~     approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to~     VATS if this procedure is reasonable. The information gained by this study will help to~     assess the significance of cryobiopsy in contrast to VATS in this particular disease group.~   "
102572|NCT01714505|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of~     a hospital based clinical research center. The principal goal is to validate a smart~     phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of~     CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger~     home-based trials of CTR.~   "
102573|NCT01714492|"~     Utilize previously developed mathematical model to determine in vivo knee mechanics~     (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior~     Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several~     hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA~     will experience polyethylene bearing rotation at 10 years post-operative, similar to their~     previous evaluations at six months, two years and five years.~   "
102574|NCT01714479|"~     Warfighters often experience physical overload, as the uniform and associated gear that they~     carry burdens them with substantial loads. The loads increase energy expenditure to levels~     that exceed a Warfighter's typical energy intake. The typical assault load is approximately~     25 kg, although loads as high as 55 kg are often carried, which when combined with extreme~     energy expenditures can degrade health and performance, and increase the risk of injury.~     Branched-chain amino acid (leucine) supplementation may confer protection against the~     negative effects of operational stress by stimulating muscle protein synthesis and reducing~     degradation. This study will determine if leucine-enriched nutrition supplementation confers~     protection against the negative consequences of sustained load carriage exercise, and~     explore the mechanisms by which leucine might impart protection.~   "
102575|NCT01714466|"~     A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel~     cleansing solution (MOVIPREP®)~   "
102576|NCT01714440|"~     The major aim of this research study is to investigate the relationship between genetic~     variation in DNA (inherited code material in the cells of the body) and factors affecting~     transplant outcomes, like the drugs people receive or the way their immune systems work, for~     example. To do this, investigators will collect blood samples from participants. Genetic~     material will be separated from each blood sample and analyzed, looking for genetic~     variation.~   "
102577|NCT01714427|"~     The purpose of this study is to investigate the local and systemic inflammatory response and~     haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to~     determine the feasibility of imaging techniques to quantify lung inflammation in an adapted~     human endotoxin instillation model.~      The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.~   "
102578|NCT01714414|"~     A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained~     virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine~     in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of~     treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory~     Coast.~   "
102579|NCT01714401|"~     Patients of the ICU's often require bronchodialtatory treatment due to bronchospazm caused~     by conditions like : ARDS, COPD or asthma. The β2 adreneregic drugs are one of the most~     commonly used for this purpose. However it is known that they may cause tachycardia and may~     have substantial proarrhythmic effect. The investigators' aim is to estimate the influence~     of nebulized bronchodilatatory drugs on selected electrophysiological parameters, whose~     changes are generally recognized as potentially increasing the risk of ventricular and~     supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and~     ipratropium bromide~   "
102589|NCT01714271|"~     This family environment-focused health behavior change intervention is being carried out by~     extensively trained community health workers (promotores) familiar with the community in~     East Los Angeles. The hypothesis being tested is that home environment-focused health~     behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart~     disease. The community health workers will provide most of the health promotion counseling.~     The promotores will provide up to 16 counseling sessions to a designated adult family member~     without diabetes. The sessions will focus on improving the home environment in order to~     reduce television viewing, increase fruit and vegetable intake, decrease intake of refined~     carbohydrates, prompt more frequent monitoring of body weight and increase daily physical~     activity. The lifestyle change goals will be tailored to the families' capacity for change~     and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov~     messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of~     daily moderate physical activity.~   "
130970|NCT01340157|"~     The present study is designed to assess the impact of concomitant food intake on the~     relative bioavailability of a single oral fexinidazole tablet administration.~   "
102580|NCT01714388|"~     Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general~     anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.~     Registration for anesthesia includes bolus dose and continuous infusion, in ICU only~     infusion regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in~     rapid onset and offset of clinical effect, which makes this drug almost ideal in many~     situations. Unfortunately, its vagomimetic influence on cardiac activity may result in~     decrease of heart rate. It may be hypothesized that patients with parasympathetic~     predominance may be prone to more intense parasympathomimetic effect of this opioid. An~     optimal method for assessment of autonomic nervous system activity and assessment of~     influence of RMFNT on that activity is Heart Rate Variability (HRV) analysis.~     Parasympathetic predominance is expressed as high frequency (HF) power and HF/(LF+HF)~     (LF-low frequency) ratio in frequency domain and Root Mean Square of the Successive~     Difference (RMSSD), the number of pairs of successive NNs that differ by more than 50 ms~     (NN50), the proportion of NN50 divided by total number of NNs (pNN50) in time domain. The~     aim of this study is to verify the hypothesis that patients with predominance of~     parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV based on 5~     minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will be~     analyzed. The occurrence of heart rate decrease will be than compared between patients with~     sympathetic and parasympathetic predominance measured prior to drug injection.~   "
102581|NCT01714375|"~     The goal of this study is to determine whether daily assessment and feedback of workers'~     noise exposures leads to more effective use of hearing protection and prevention of~     noise-induced hearing loss.~   "
102582|NCT01714362|"~     Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This~     phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac~     features of this reflex include hypotension, dysrhythmias, atrioventricular block. These~     cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.~     Patients with existing cardiovascular disease are in risk of complications. Cardiovascular~     system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic~     activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5~     minutes electrocardiography has been found useful for prediction of hypotension and~     bradycardia during induction of general anaesthesia and during spinal block. The aim of this~     study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV~     analysis for ANS activity assessment, measured prior to the ophthalmic surgery.~   "
102583|NCT01714349|"~     Nerve Transfer surgery can provide improved hand function following cervical spinal cord~     injuries~   "
102584|NCT01714336|"~     Does tranexamic acid improve the perioperative care of those patients treated surgically for~     hip fracture by decreasing the proportion of patients requiring transfusion and decreasing~     total perioperative bleeding.~   "
102585|NCT01714323|"~     Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public~     Health Service Smoking Cessation Guideline recommends offering effective treatment to~     smokers in all health care settings, including hospitals. Nearly 4 million smokers are~     hospitalized each year, and hospital admission offers a teachable moment for intervention.~     Hospital-initiated smoking cessation intervention is effective, but only if contact~     continues for more than 1 month after discharge. The challenge is to translate this research~     into clinical practice by identifying an evidence-based cost-effective model that U.S.~     hospitals can adopt. The major barrier is sustaining contact after discharge. This project~     tests an innovative strategy to streamline the delivery and maximize the uptake of~     post-discharge smoking interventions.~      Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use~     of evidence-based tobacco treatment (counseling and medication) after hospital discharge,~     thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco~     abstinence.~      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll~     1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All~     subjects will receive a brief in-hospital smoking intervention and be randomly assigned at~     discharge to either Standard Care (passive referral to their state quitline) or Extended~     Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved~     medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and~     refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive~     Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR~     aims to encourage medication adherence and enhance counseling efficiency by identifying~     smokers who need post-discharge support. Immediate transfer of a patient from automated IVR~     call to live telephone counselor will facilitate a successful connection to counseling.~      Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention~     effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month~     follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment~     utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine~     the intervention's effect on hospital readmissions and mortality in the 6 months after~     discharge.~   "
102586|NCT01714310|"~     This project will characterize children and adolescents with severe mood dysregulation (SMD)~     and conduct a pilot study of combination pharmacotherapy as a basis for future intervention~     trials.~      Eligible participants assessed for SMD will have 4 weeks open titration with~     lisdexamfetamine (LDX) to optimal dose, followed by double-blind randomization to fluoxetine~     (N=25) or placebo (N=25) in combination with optimized LDX for an additional 8 weeks.~     Participants will be monitored for clinical response and adverse events.~      Specific aims are:~      #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive~     functioning, and a potential bio-signature derived from electroencephalography (EEG).~      Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison~     to non-SMD individuals in our pre-existing database on patterns of a) psychiatric~     comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2)~     that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with~     SMD.~      #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant~     followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI)~     therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability~     of the proposed combination treatment as a basis for future clinical investigations.~      Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global~     Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident~     after open-label LDX titration; 2) that participants randomized to fluoxetine will~     demonstrate additional significant improvement in CGI-I-SMD scores and other secondary~     measures in comparison to participants randomized to placebo; 3) that combination LDX and~     SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with~     treatment.~   "
102587|NCT01714297|"~     The purpose of this study is to determine if there are differences in clinical events, i.e~     bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight~     Heparin) is initiated before or after surgery.~   "
102588|NCT01714284|"~     This is a multicenter randomized controlled clinical trial evaluating the impact of a~     structured non pharmacological intervention consisting in intensive weight reduction~     (qualitative and quantitative changes in diet associated with physical exercise) compared to~     an intervention based on a simple informative counseling about the utility of weight loss~     for clinical control of psoriatic disease.~   "
102610|NCT01713998|"~     Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on~     the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study~     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up~     visit.~   "
102590|NCT01714258|"~     The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and~     pulmonary artery thermodilution , are both invasive methods, requiring the use of central~     venous catheter and Swan-Ganz catheter, respectively.~      With the aim to reduce the risks for the patient, a big research effort has been made to~     investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the~     effectiveness of a non invasive method to estimate CO in mechanically ventilated~     patients.The method is based on prolonged expiration, and relies on measurement of gas~     concentrations and flow rate. Investigators designed, realized, and characterized a system~     to induce passive prolonged expirations when connected to the patient circuit.~      CO is then calculated using an algorithm based a modified version of the Fick equation and~     the results are compared with the ones obtained by thermodilution.~      Several advantages can be introduced by the prolonged expiration technique: non-invasive~     measurement, easy implementation, independency from operator ability among others.~   "
102591|NCT01714245|"~     The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser~     formulated with surfactants and preserved with sodium hypochlorite, is effective at~     decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or~     eczema.~   "
102592|NCT01714232|"~     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose~     Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from~     other manufacturers. All meter BG results were compared with plasma results obtained with a~     reference laboratory glucose method (YSI Glucose Analyzer).~   "
102593|NCT01714219|"~     Incontinence is one of the most common complications of radical prostatectomy. The~     continence rate is not significantly improved even by robot-assisted laparoscopic~     prostatectomy (RALP). However, some reports suggested that posterior reconstruction (PR)~     behind vesicourethral anastomosis could improve early recovery of continence during open,~     laparoscopic or robot-assisted radical prostatectomy.~      But, recent prospective studies reported no benefit of PR after RALP, which was the opposite~     result of those of previous studies. However the PR techniques used in these prospective~     studies seem to be quite different from the previous techniques. They seem to have used~     single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the~     Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional~     reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder~     neck.~      Our group identified this anatomic structure as the posterior counterpart of the detrusor~     apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more~     appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the~     key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step~     reconstruction between MDFR and PDA could be enough for PR. We previously investigated~     whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would~     improve continence recovery compared with the standard RALP technique without PR. And our~     retrospective study demonstrated that this new PR technique during RALP significantly~     shortens the time to the recovery of continence compared with the standard technique, which~     does not incorporate PR (Int J Urol, 2012;19:683-7).~      Thus, we plan to validate this result by a well-designed, prospective, randomized controlled~     study.~   "
102594|NCT01714206|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of~     digoxin. The safety and tolerability of canagliflozin will also be assessed in healthy~     volunteers.~   "
102595|NCT01714193|"~     The purpose of this study is to investigate whether there is a drug-drug interaction between~     multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive~     containing ethinyl estradiol and levonorgestrel. The safety and tolerability of~     canagliflozin will also be assessed in healthy volunteers.~   "
102596|NCT01714180|"~     Studies have shown that different percentages of body fat can alter the way drugs are~     distributed in the body. This study will use blood samples taken at different time points~     for patients taking acyclovir to determine if higher body weights affect drug exposure. The~     information gathered from this study will help understand if patients with higher body~     weights need a different dosing plan.~      Patients receiving acyclovir as standard of care will be enrolled into this study. They will~     have blood draws once before they take acyclovir and 10 times after they take the acyclovir~     (over a total of 12 hours). These patients will be in the hospital already and will not need~     to make additional trips back to have blood drawn. A total of about 4—5 tablespoons of blood~     will be drawn for this study. 7 obese patients and 7 matched, non—obese patients will be~     enrolled into this study.~   "
102597|NCT01714167|"~     Stroke is one of the leading causes of disability in the world, and stem cell -~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow~     mesenchymal stem cells in patients with chronic stroke.~   "
102598|NCT01714154|"~     This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate~     the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with~     ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy~     controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in~     Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10~     days in Period 2, with a washout phase of at least 9 days between treatments.~   "
102599|NCT01714141|"~     This pilot study's main goal is to develop and preliminarily test a technology-based~     intervention to improve asthma medication adherence in urban African American emerging~     adults (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will~     show improvements in motivation to adhere to asthma medications and self-reported adherence~     compared to the comparison condition at 1- and 3- month follow up.~   "
102600|NCT01714128|"~     A significant number of all invasive breast cancers are hormone sensitive and may be~     candidates for treatment with hormonal therapy.~      This project will assess the ability and usefulness of imaging hormone-receptor status in~     breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol~     (FES), an estrogen analogue in patients who are scheduled to be treated with hormonal~     therapy given in combination with a selective allosteric inhibitor of AKT protein kinase~     (MK2206) .~   "
102601|NCT01714115|"~     This is a single patient investigative treatment study. The patient was diagnosed with a~     retinal tumor in one eye. In the last 2 years, the patient has been treated with all~     available and conventional therapies, including intraocular injections of Avastin and~     Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and~     caused an eventual decline in central vision. Aflibercept has been shown to be effective~     against the growth of new vessels, secondary to macular degeneration. This study proposes~     that it may also be more effective in treating this particular patient and case. The study~     treatment plan is for 6 months initially, with the intention to continue treatment.~   "
102602|NCT01714102|"~     Metabolic syndrome is a serious health condition that affects about 35 percent of adults and~     places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related~     to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity,~     being overweight, physical inactivity and genetic factors. In recent decades, the prevalence~     has increased dramatically in the United States. Lifestyle interventions including dietary~     modification, physical activity and weight loss form the basis of treatment for these~     patients. However, research has shown that even when people are able to incorporate these~     changes, they often revert back to their usual lifestyle resulting in weight gain and~     continued risk for diabetes and heart disease.~      Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has~     been found to reverse some of the features of the metabolic syndrome (insulin resistance,~     high triglycerides, high blood pressure) in rodents. These improvements occurred without~     weight loss, and were proven to be a direct result of resveratrol ingestion. Other studies~     reveal improvement in cardiovascular health, tumor suppression, and longevity. However,~     there are few studies investigating these beneficial effects in humans. Investigators~     propose to prove that resveratrol, administered to subjects with the metabolic syndrome,~     under controlled conditions of weight stability, common diet, and strict compliance with the~     study drug, will improve the symptoms of the metabolic syndrome, thereby decreasing the~     chance of developing diabetes or heart disease.~   "
102603|NCT01714089|"~     The purpose of this study is to determine whether RNS60 is effective in the treatment of~     RR-MS compared to interferon beta-1a.~   "
102604|NCT01714076|"~     Observational cohort study in children hospitalized for acute bronchiolitis. Patients are~     nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of~     co-infections in this group.~   "
102605|NCT01714063|"~     The primary objective of this study is to determine ex vivo the amount of fluticasone~     deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC~     mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation~     maneuver.~   "
102606|NCT01714050|"~     Major depression is a highly prevalent, chronic, and debilitating mental health problem with~     significant social cost that poses a tremendous economic burden. Winter seasonal affective~     disorder (SAD) is a subtype of recurrent major depression involving substantial depressive~     symptoms that adversely affect the family and workplace for about 5 months of each year~     during most years, beginning in young adulthood. This clinical trial is relevant to this~     public health challenge in seeking to develop and test a time-limited (i.e., acute treatment~     completed in a discrete period vs. daily treatment every fall/winter indefinitely),~     palatable cognitive-behavioral treatment with effects that endure beyond the cessation of~     acute treatment to prevent the annual recurrence of depression in SAD.~      Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light~     therapy on depression recurrence status, symptom severity, and remission status during the~     next winter season (i.e., the next wholly new winter season after the initial winter of~     treatment completion), which we argue to be the most important time point for evaluating~     clinical outcomes following SAD intervention.~      Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less~     severe symptoms, and a higher proportion of remissions than light therapy in the next~     winter. The study is designed to detect a clinically important difference between CBT and~     light therapy in depressive episode recurrences during the next winter, the primary~     endpoint, in an intent-to-treat analysis.~      Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission~     status at post-treatment (treatment endpoint).~      Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.~   "
102607|NCT01714037|"~     Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in~     combination with standard of care chemotherapy for the first- and second-line treatment of~     advanced NSCLC.~   "
102608|NCT01714024|"~     The purpose of this research study is to compare the healing differences of two metals~     (trabecular vs. standard titanium) that are used for dental implants. In addition;~     investigators will be examine these differences in the gene expression profiles in subjects~     with three conditions associated with delayed healing: diabetes and osteoporosis.~      The study will last at least 11 weeks consisting of 6 appointments. All visits will be~     carried out at the GO Health Center within the UNC School of Dentistry. Visits will last~     between 30 minutes to 3 hours depending on the particular visit.~      The visits will consist of: Obtaining consent, doing a health history, measuring vital~     signs, doing dental exams of the teeth and gums, collecting samples of saliva dental~     radiographs (X-rays), a teeth cleaning, having 4 temporary mini test cylinders placed in~     areas of the lower jaw where teeth are missing and implant surgery to place up to four~     permanent implants.~   "
102609|NCT01714011|"~     Introduction:~      Schizophrenia is a serious mental illness. For majority of patients it is a lifetime~     condition,characterized by intermittent episodes of hospitalization due to relapse or acute~     symptom exacerbation. The nature and course of the disorder impose significant social and~     economic burden. Relapse is costly, with hospitalization accounting for a substantial~     portion of healthcare expenses. Second generation antipsychotic side effect such as~     metabolic syndrome and diabetes mellitus will contribute additional costs to the treatment.~      Many studies have since then provided convincing evidence for a high risk of diabetes and~     other glucose abnormalities, metabolic syndrome and mortality due to elevated cardiovascular~     risk in patients with schizophrenia.~      However many studies has shown the effectiveness and safety of aripiprazole and~     ziprazidone.In one of the study, aripiprazole showed improvement of negative schizophrenic~     symptoms by 25% and 50% of functioning level from baseline. In term of safety,~     antipsychotics considered to have a safer metabolic profile were amisulpride, ziprasidone~     and aripiprazole.~      Study objectives:~        -  To investigate the safety and efficacy of ziprazidone versus aripiprazole in the~          treatment of schizophrenia patients with metabolic syndrome and diabetes mellitus.~        -  To investigate the reversibility of metabolic syndrome and diabetes parameters~          following the treatment with ziprazidone versus aripiprazole.~      Hypotheses:~      * The proportion of reversibility of metabolic syndrome and diabetes parameters is higher~     following the treatment of ziprazidone than aripiprazole.~   "
102927|NCT01709825|"~     The purpose of this study is to determine if daily consumption of a probiotic in the period~     before, during and after academic exams will help maintain digestive and immune health and~     quality of life of undergraduate students.~   "
102613|NCT01713959|"~     Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two~     treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at~     7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days~     post-treatment #2.~   "
102614|NCT01713946|"~     This study will evaluate the efficacy and safety of two trough-ranges of everolimus given as~     adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory~     partial-onset seizures.~      The study consists of 4 phases for each patient [Baseline phase: From Screening Week -8 (V1)~     to randomization visit at Week 0 (V2)], Core phase, from randomization at Week 0 (V2) to~     Week 18 (V11)], Extension phase from Week 18 (V11) until 48 weeks after the last patient has~     completed the core phase, and Post Extension Phase [after the end of the Extension phase~     until August 31, 2017].~   "
102615|NCT01713933|"~     This study is an evaluation of the Ulthera® System used to treat the upper arms for~     improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm~     treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.~   "
102616|NCT01713920|"~     A majority of Korean doctors tend to add other antihypertensive rather than to titrate the~     same drug.~      However, we try to induce doctors to titrate the Sevikar than to add other antihypertensive~     if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As~     above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to~     other prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.~      It is important to evaluate BP lowering efficacy of Sevikar through the titration step in~     patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the~     efficacy of Sevikar by titration in patients who are not controlled their BP with low dose~     of Sevikar.~   "
102617|NCT01713907|"~     Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on~     the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study~     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up~     visit.~   "
102618|NCT01713894|"~     The purpose of this study is to assess in a pilot randomized controlled trial the following~     PICOT question: In parents facing extreme premature delivery, does the use of an existing~     validated visual decision aid as compared to standard counseling, reduce the primary outcome~     of parental decisional conflict? Furthermore, is such a decision aid understood and~     applicable across differing populations of different ethnic backgrounds and social classes?~   "
102619|NCT01713881|"~     This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and~     were found to have a tubular adenoma between the years of 2004-2008. We will compare the~     rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp~     registry (tracking system) in 2006. Each group will be composed of up to 500 subjects~     consecutively identified from all the patients who underwent colonoscopy and were found to~     have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).~   "
102620|NCT01713868|"~     The goal of this proposal is to address serious and ongoing challenges related to adherence~     to public health recommendations known to reduce the risk of SIDS. Adherence has reached a~     plateau at an unacceptably low level both in the overall US population and especially in~     Black infants leading to a halt in the decline in infant mortality and a widening in the~     racial disparity in infant mortality. The current proposal is a collaborative effort that~     will capitalize on the extensive experience of the investigators in studying barriers to~     adherence to safe sleep practices to develop two complementary, culturally competent,~     intervention strategies and to test the effectiveness of each strategy as well as both~     strategies in combination. Innovative aspects of the Social Media and Risk-reduction~     Training of Infant Care Practices (SMART) study include its: 1) unique collaboration of~     leaders in the field; 2) leveraging of the currently operational infant care practices study~     infrastructure and hospitals; 3) use of two complementary interventions with the potential~     for synergistic impact; 4) use of social marketing strategies;5) use of mobile technology~     (mHealth) to deliver messages; and 6) collaboration with community resources and expertise.~     The SMART study will have four arms in which 16 hospitals are randomly assigned to one of~     the following study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth~     messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe~     Sleep Nursery Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education~     and Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited~     (100/hospital), with 400 in each study group. The primary aim is to assess the effectiveness~     of the interventions aimed at promoting safe sleep practices compared with the breastfeeding~     control interventions. The secondary aim is to assess potential mediating factors that may~     explain the intervention effects on infant care practices and that may inform areas for~     future improved intervention approaches. With the successful completion of the SMART study,~     effectiveness data will have been provided for two interventions to improve adherence to~     safe sleep practices that are practical to disseminate nationally in multiple diverse~     settings.~   "
102621|NCT01713855|"~     The purpose of this study is to determine how children with a history of severe, chronic~     Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to~     vaccines. Eligible patients are previously or currently enrolled in a study entitled Open~     Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura~     in Children and Adolescents and have decided to obtain an inactivated influenza~     vaccination. These patients will be invited to provide one blood sample prior to vaccination~     and a second sample following vaccination to quantify immune response to vaccination.~   "
102622|NCT01713842|"~     Phase 1:~      Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation~     is performed using PMR-AS.~      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting~     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale~     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)~     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).~      At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.~      Phase 2:~      All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3~     months. Two arms are possible according to the PMR-AS. Either the classical GC treatment~     (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .~   "
102623|NCT01713829|"~     The purpose of this study is to determine the extent to which consuming a cranberry beverage~     modifies immune function, specifically related to γδ T cells and other innate immune cells.~     It is hypothesized that cranberry components will interact with immune cells to activate~     signaling pathways that enhance cell function. Enhanced immune cell function should result~     in reduced number, duration, and severity of cold and flu symptoms.~   "
102624|NCT01713816|"~     Antioxidants are important for having a good memory and for smart thinking when people get~     old, and that is important for everyone's quality of life. This research will find out if~     normal aging and Alzheimer's disease use up brain antioxidants. It will develop a new~     imaging tool that can help doctors to stop cognitive decline.~   "
116636|NCT01529359|"~     The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane~     Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).~   "
102625|NCT01713803|"~     This is a randomized, double blind, placebo controlled study in opioid dependent subjects.~     Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo,~     with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as~     follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal~     scale (COWS), subject-rated assessments, and a urine drug screen.~   "
102626|NCT01713790|"~     This study aims to examine long term effects in the training gain stage of the falls~     management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical~     functional performance after mechanical SR-WBV, dance therapy and strength training~     intervention in a frail elderly population.~   "
102627|NCT01713777|"~     The United States Food and Drug Administration (FDA) has specific rules generic drug~     companies must follow to get a generic copy of a seizure medication approved. Currently, the~     FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy~     and who take just one dose of the generic drug followed by a series of blood tests. Some~     people with epilepsy and their physicians have complained about side effects or loss of~     seizure control when taking generic drugs, but no one knows if these complaints are truly~     because of problems with the generic drugs.~      When the FDA tests generic copies of lamotrigine (LTG), the blood levels measured after~     volunteers receive the generic lamotrigine tablets are allowed to fall within a specific~     range. This research will test whether two different manufacturer's generic lamotrigine,~     that fall in different parts of that range, perform in a similar way when given to people~     with epilepsy every day over a several week period. The two products will be called GENERIC~     A and GENERIC B.~      The generic forms of the study drug lamotrigine to be tested in this study are approved by~     the FDA for the treatment of seizures.~   "
102628|NCT01713764|"~     The study is a small pilot, designed to provide data regarding the feasibility and~     acceptability of conducting such a study on a larger scale. The present study is a~     randomized controlled clinical trial comparing two mindfulness-based lifestyle modification~     programs to help people manage diabetes and lose weight, one using on a low-carbohydrate~     diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes~     Association (ADA). Intervention content will include information about nutrition~     (carbohydrate restriction or American Diabetes Association recommended diet) and emotion~     regulation and mindful eating strategies.~   "
102629|NCT01713751|"~     The aim of this study is to determine the surgical site infection rate and patient~     satisfaction for subcuticular versus interrupted mattress suture in closure of skin at~     Cesarean delivery in obese patients.~   "
102630|NCT01713738|"~     The purpose of the study is to evaluate the safety and efficacy of rituximab in children~     ages 18 months to 18 years, who have severe, chronic ITP. Eligible patients with either~     primary or secondary ITP are treated with rituximab once a week for 4 doses, and then~     followed for up to one year. Response is defined as having a platelet count greater than or~     equal to 50,000/mL on four consecutive weekly measures beginning anytime in weeks 9 - 12.~   "
102631|NCT01713725|"~     Chronic urticaria can be defined as the occurrence of widespread daily or almost daily~     wheals for at least 6 weeks, which may be accompanied by angioedema. While the wheals are~     transient, the resolution of angioedema is slower than wheals and could take up to 72 hours.~     The natural course of chronic urticaria is self-limited, with spontaneous remissions and~     occasional relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval):~     0.4-0.8) prevalence in a population study. It has a great impact on patients' quality of~     life. In a recent national survey on patients attending Allergy Department, chronic~     urticaria was the disease with greater impact on mental quality of life out of all allergic~     diseases.~      In spite of the high morbidity of this disease and the impact in quality of life, there is~     no available treatment. Last guidelines recommend initiating treatment with antihistamine~     and if there is no response to increase the dose off-label up to four-fold; systemic~     corticosteroids are also recommended in short tapering and if no response, the only~     treatment with clinical evidence to be employed is cyclosporine. As additional data, the~     treatment cost of this disease has been calculated in 2047$/year.~      In past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE)~     antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale~     for this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the~     high affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of~     mast cells and basophils so that immunoglobulin G cross linking of the alpha subunit and~     basophil degranulation is prevented.The hypothesis the investigators are working on is that~     monoclonal IgE antibody Omalizumab could be effective in controlling chronic urticaria~     symptoms in patients non respondent to conventional therapy. The investigators hypothesize~     that Omalizumab is able to revert the basophil or mast cell activation present in chronic~     urticaria.~   "
102632|NCT01713712|"~     The purpose of this study is to evaluate the effect of access to nutrition services on~     pregnancy outcomes in the obese urban population. There are many studies that have shown~     that obesity has a negative impact on pregnancy. However, currently there are only a few~     small studies that specifically look at ease of access to nutrition services in an obese~     urban population and the effect this has on maternal weight gain and pregnancy outcomes.~     This study will compare two groups of pregnant women with a BMI of 30 or greater. The~     investigators hypothesize that access to nutritional services will lead to decreased weight~     gain during pregnancy and improved pregnancy outcomes.~   "
102633|NCT01713699|"~     The purpose of this study is to determine whether the quantitative detection of circulating~     tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard~     qualitative method - cytology both in the cerebrospinal fluid of patients, clinically~     suspected for leptomeningeal metastases.~   "
102634|NCT01713686|"~     This is prospective, multi-center clinical trial. Enrolled subjects will receive one~     Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days~     following treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit.~   "
102635|NCT01713673|"~     Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or~     Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™~     treatment will have a greater reduction in axillary sweating compared to subjects receiving~     Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at~     7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will~     be completed to compare the amount of axillary sweating compared to baseline.~   "
102636|NCT01713660|"~     The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract~     surgery.~   "
102637|NCT01713647|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid~     losartan metabolite & Hydrochlorothiazide in plasma and calculation of the bioequivalence~     parameters from those measurements followed by ANOVA and 90% confidence interval statistical~     evaluation.~   "
102638|NCT01713634|"~     Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a~     condition that affects millions of men and women on Earth each year. Many countermeasures to~     bone loss have been proposed, and many have been evaluated to some degree. To date, those~     showing potential have focused on either exercise or pharmacological interventions, but none~     have targeted dietary intake alone as a factor to predict or minimize bone loss during~     spaceflight. The investigators proposed to document how the ratio of acid precursors to base~     precursors in the diet is related to directional changes in markers of bone resorption and~     formation during flight and recovery from flight. There is a high likelihood for success in~     predicting the extent of bone loss from dietary intake patterns of astronauts during~     spaceflight, given that this concept is strongly anchored in data obtained from ground-based~     experiments in our laboratory and others. The notion of manipulating diet to minimize bone~     loss could also have significant social and economic impacts for NASA and for the general~     public - especially given the increasing trends for diets that are high in animal protein~     and low in fruits and vegetables. The results of the proposed experiments will lead to~     development of a dietary countermeasure for bone loss consisting of a balanced diet with no~     associated risks for side effects that might be present with pharmaceuticals or supplements,~     no requirement for payload mass, and no additional crew time necessary during flight.~   "
102639|NCT01713621|"~     This study aims to investigate the concentration dependent effects of OZ439 on the clearance~     of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum~     inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD~     (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based~     dosing. The adaptive investigation of a range of doses will provide the best chance of~     accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth~     dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal~     concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be~     confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on~     parasitaemia will be investigated.~   "
102640|NCT01713608|"~     A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration~     of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:~        -  To determine the safety and tolerability of ascending doses of OZ439 OD for three days.~        -  To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.~        -  To identify the maximum tolerated dose of OZ439 administered.~   "
102641|NCT01713595|"~     To determine if an inhaled hypertonic saline solution has any effect on lung function in~     patients with acute respiratory distress syndrome (ARDS).~   "
102642|NCT01713582|"~     The primary purpose of this study is to determine the recommended dose (RD) of~     OTX015/MK-8628 for further phase II studies, in participants with acute leukemias (acute~     myeloid leukemia [AML; de novo and secondary to a myelodysplastic syndrome] or acute~     lymphoblastic leukemia [ALL]) or hematologic malignancies (diffuse large B cell lymphoma~     [DLBCL] or multiple myeloma [MM]).~   "
102643|NCT01713569|"~     Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical~     facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound~     exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48~     hours post-treatment, on the day of their rhytidectomy. Study images will be obtained~     pretreatment, immediately post-treatment, and at the follow-up visit.~   "
102644|NCT01713556|"~     The purpose of this study is to test whether propranolol, when given during a re-evocation~     of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that~     memory.~   "
102645|NCT01713543|"~     Background: Falls are the leading cause of injury among older adults in Singapore, but falls~     among the elderly can be preventable and the risks are predictable. Translating this~     understanding of falls etiology into an integrated clinical and public health program that~     is accessible to the elderly is a critical health services delivery challenge.~      Hypothesis: An evidence-based program of screening, risk modification and physical therapy~     delivered in a community setting will reduce recurrent falls incidence among a high-risk~     group of elderly recently discharged to the community.~      Methodology: This randomized controlled trial targets patients seen at Emergency Department~     (ED) for a fall or fall-related injuries who are at least 65 years old and will be~     discharged to home. Upon signing the informed consent form, the participants will be~     followed up for nine months from the baseline assessment during which the participants are~     randomized into either a control or the intervention group. The participants in the~     intervention group will be provided with a multifactorial program of screening, risk~     modification and physical therapy focused on progressive strength, balance, and gait~     training either as an individualized program or a group setting in the community for the~     first three months from the date of randomization. The number of recurrent falls will be~     monitored via a falls prevention diary maintained by (or for) each participant.~   "
102646|NCT01713530|"~     This trial is conducted in Africa, Europe and the United States of America (USA).~      The aim of the trial is to compare the difference in change in glycosylated haemoglobin~     (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs~     (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.~   "
102647|NCT01713517|"~     The purpose of the study is to determine whether long lasting insecticidal nets and indoor~     residual insecticide spraying, alone or in combination, are effective for controlling~     insecticide resistant anopheles mosquitoes for malaria prevention.~   "
102648|NCT01713504|"~     The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative~     and more accessible compared to those that we have already thanks to a proteomic approach.~     This will help the investigators to diagnose the this disease.~   "
102658|NCT01713374|"~     The purpose of this study is to determine whether interventions aimed at increasing~     sympathetic tone modify endothelial function measures as assessed by the measurement of~     flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the~     three interventions under study will increase FMC while causing a blunting in FMD.~      Further, the investigators plan to study the circadian variability of FMC and FMD. The~     investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in~     the early hours.~   "
103359|NCT01704196|"~     The objective of this study is to evaluate the safety and efficacy of Nepicastat in~     improving the number of subjects that achieve abstinence from cocaine and reducing cocaine~     use in subjects with cocaine dependence.~   "
102649|NCT01713491|"~     At the acute stage of cerebral ischaemia, the only effective drug that increases the~     proportion of patients who survive without dependency is thrombolytic therapy by intravenous~     (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice~     with similar results than in trials, in various places of the world including Europe and~     Japan.~      Stroke and dementia are closely related. About one patient in ten has dementia before a~     first-ever stroke, and more than one in three has dementia after a recurrent stroke.~     Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing~     cognitive impairment without dementia is associated with a higher rate of~     institutionalisation within 3 years. In many patients cognitive impairment is due to the~     summation of the effects of vascular and Alzheimer lesions of the brain.~      More and more patients nowadays who are eligible for rt-PA are already known as demented at~     admission. A retrospective study conducted in a cohort of patients with dementia who had an~     ischaemic stroke and were treated by rtPA suggested that there is no increased risk of~     cerebral bleeding and death as compared with non demented patients. However, pre-existing~     cognitive impairment is possibly associated with (i) an increased risk of bleeding in~     patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect~     of rt-PA on the brain tissue.~      Japanese patients differ from European patients by a higher risk of spontaneous intracranial~     haemorrhage, and a higher proportion of patients with small-vessel diseases.~      The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke~     patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as~     a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive~     impairment or dementia. The secondary objectives are to determine whether (i) they have an~     increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients~     who have a poor outcome is lower than expected from the placebo group of randomised trials~     for patients with a similar range of baseline severity, and (iii) the influence of the~     cognitive state on outcome differs between Japanese and European patients.~   "
102650|NCT01713478|"~     The prevalence of hepatic cirrhosis in Romania is very high, with a 10-year mortality of~     34-66%. Upward trend of mortality is observed. It is known that cirrhosis is associated with~     cardiac abnormalities. These can induce several complications of cirrhosis, and increase~     postoperative mortality. Therefore, it is a major public health issue and research in this~     field should be a priority.~      Few studies evaluated the cardiac function in cirrhotic patients, using only conventional~     echocardiography. However, this allows only the late diagnosis of cardiac dysfunction, which~     might be already irreversible. Consequently, description of new parameters, which could~     detect early dysfunction, becomes essential. There is no study designed to estimate~     intrinsic myocardial properties in cirrhosis. New methods (Tissue Doppler and~     Speckle-tracking echocardiography) could be essential to detect early cardiac dysfunction.~     The exact role of biological markers in the diagnosis of cardiac dysfunction remains to be~     clarified. Impaired cardiac function coupled with augmented vascular function could be the~     model for cirrhotic patients. This type of ventriculo-arterial interaction has never been~     described.~      The main objectives of our project are:~        1. to investigate the mechanisms which lead to cardiac dysfunction;~        2. to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;~        3. to describe the type of ventriculo-arterial interaction;~        4. the association between biological markers and echo parameters.~   "
102651|NCT01713465|"~     The objective of the proposed study is to design and evaluate a touch screen computer based~     multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse~     Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study~     objective is to improve metabolic syndrome related knowledge, attitude and practices among~     individuals using the proposed interactive, bilingual computer based educational program.~   "
102652|NCT01713452|"~     Stoma closure has been associated with a high rate of surgical site infection (SSI). The~     rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than~     expected for a clean-contaminated operative classification. The ideal stoma site closure~     technique is still debated in the current literature. The aim of this study was to compare~     the rate of SSI following two different stoma closure techniques, primary closure versus a~     skin approximating purse string closure, in a multi-center randomized controlled trial. The~     investigators hypothesize that purse string closure technique will have a lower rate of SSI~     than primary closure technique.~   "
102653|NCT01713439|"~     The patient's have neuroblastoma that has come back, or not gone away. The cancer is harder~     to treat now. The investigators would like the patient's to be in this research study to~     determine the safety and dosage of special cells that may make the patient's own immune~     system fight the cancer. To do this the investigators will put two special genes into~     neuroblastoma cancer cells that have been grown in the lab. The genes put in make the cancer~     cells produce lymphotactin, a natural substance that attracts immune system cells to the~     cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some~     of these cells will then be put into the patient's body. Studies of cancers in animals and~     in cancer cells that are grown in laboratories suggest that substances like lymphotactin and~     IL-2 do help the body kill cancer cells. A treatment similar to this has been used in twelve~     children previously and similar treatments are being used in adults with other cancers. This~     is a research study. The investigators do not know the best amount of special cells to use,~     so different children will get different numbers of cells.~      The purpose of this study is to learn the side effects and safe dosage of these special~     cells. Participation in this study will last for 15 years.~   "
102654|NCT01713426|"~     This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in~     patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of~     these treatments and the duration of the study will be about 10 weeks (assuming that from~     screening to treatment allocation takes 2 weeks). Participants will be asked to complete~     questionnaires about various aspects relating to their condition throughout the study.~      This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve~     Injury or Non Diabetic peripheral polyneuropathy.~   "
102655|NCT01713413|"~     The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long~     term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,~     the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.~      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard~     to the blood oxygenation during exercise testing. Given that the endurance time is very~     sensitive for little changes in exercise capacity, this test will be used to show the~     difference between the Oxymizer® and a conventional nasal cannula regarding exercise~     duration at 70% of peak Watt and oxygenation.~      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and~     heart rate.~   "
102656|NCT01713400|"~     To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell~     (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30~     post-hematopoietic cell transplantation (HCT).~   "
102657|NCT01713387|"~     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus~     S-1 combination therapy in patients with biliary tract cancer undergoing resection without~     major hepatectomy~   "
102659|NCT01713361|"~     The purpose of this study is:~        -  To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of~          bleeding and VTE, in patients undergoing total knee arthroplasty.~        -  To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less~          than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.~   "
102660|NCT01713348|"~     To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic~     control by;~        1. regularly checking and understanding Continuous Glucose data & trend arrows at times~          other than the standard pre-meal bolus calculation test times and~        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care~          Professional (HCP) and adjusting behaviours & therapy from interpretation of the~          Continuous Glucose profiles.~   "
102661|NCT01713335|"~     The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.~     Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide~     bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess~     Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be~     included: Healthy smoker subjects, stable COPD patients and COPD patients with acute~     exacerbation. Kallicrein levels in sputum will be compared in these groups.~   "
102662|NCT01713322|"~     Immunization procedures are a common source of iatrogenic pain for infants. A recently~     developed clinical practice guideline, led by Taddio et al., created evidence-based~     strategies for management of immunization pain. User-friendly educational tools outlining~     these strategies were made. The goal of cluster randomized controlled trial is to assess~     whether these educational materials increase utilization of pain-relieving strategies by~     parents during infant immunizations.~   "
102663|NCT01713309|"~     This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically~     ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a~     prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients~     with acute respiratory failure requiring intubation. In this substudy, the investigators~     evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.~   "
102664|NCT01713296|"~     Investigators propose to study the single agent activity of pazopanib in a Phase II trial of~     patients with relapsed or refractory small cell lung cancer. Because these patients have~     very limited treatment options, use of an investigational agent in this patient population~     is supported by current National Comprehensive Cancer Network guidelines. Using correlative~     biologic studies to evaluate the anti angiogenic activity of pazopanib in the absence of~     concomitant chemotherapy will allow us to delineate the responses due to this drug and the~     effect on angiogenesis.~      Pazopanib dose has been determined to 800 mg once daily per the initial recommended dose~     approved by FDA and EMA, as monotherapy in advanced Renal Cell Carcinoma~   "
102665|NCT01713283|"~     This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir~     (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus~     (HCV) infection.~   "
102666|NCT01713270|"~     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with~     drug-resistant hypertension and symptomatic atrial fibrillation.~   "
102667|NCT01713257|"~     This study intends to investigate the clinical outcomes of a new immunoenhancing formula~     which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU~     patients.The study design is multicenter, double-blind randomized controlled study with 3~     periods of Screening, Run-in and Randomization period.~      Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine~     free in medical-surgical ICU patients.~      Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free~     formula.~   "
102668|NCT01713244|"~     RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of~     use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the~     small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely~     accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian~     countries. But the effectiveness of hepatectomy was depressed because of the high recurrence~     rate. The spreading of the cancer cell along the portal vein or the hepatic vein system~     during the operation account for the tumor recurrence. Using RFA to ablate and block the~     small vessels around the tumor before resection will reduce the spreading of the cancer~     cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower~     recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose~     of this study was to prospectively compare the effects of RFA assisted hepatectomy with~     hepatectomy alone for the treatment of advanced HCC.~   "
102669|NCT01713231|"~     -  Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher~          than currently prescribed doses has a beneficial effect on the skeleton of young~          patients with osteogenesis imperfecta (OI).~        -  Specific Aims: 1. To determine whether 12 months of high-dose vitamin D~          supplementation, compared to standard-dose vitamin D supplementation, increases areal~          bone mineral density z-scores at the lumbar spine. 2. To examine the effectiveness of~          high-dose vitamin D supplementation to increase trabecular and cortical bone mineral~          density at the radius. 3. To examine whether high-dose vitamin D supplementation has an~          effect on physiological determinants of bone mass (parathyroid hormone, activity of~          bone metabolism, muscle function).~        -  Background: In a preliminary cross-sectional study of 282 OI patients we observed an~          inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels~          and a positive relationship between circulating levels of 25-hydroxyvitamin D and~          lumbar spine areal bone mineral density z-scores. This suggested that high-dose vitamin~          D supplementation would have a beneficial effect on bone density. Most OI patients~          currently receive oral vitamin D supplementation of 400 International Units per day,~          but doses of 2000 International Units per day are safe and have been shown to be~          beneficial in studies on healthy adolescents.~        -  Study Design: This is a parallel-group double-blind randomized controlled trial of 12~          months duration on 60 children and adolescents aged 6 to 19 years with a clinical~          diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3~          at a dose of 2000 international units per day ('high-dose group'). The other group of~          30 participants will be randomized to receive vitamin D3 at a dose of 400 international~          units per day ('standard-dose group'). Randomization will be stratified according to~          pubertal status and bisphosphonate treatment status.~        -  Clinical Relevance: The proposed study aims at direct improvements in the care of OI~          patients. If a simple and low-cost 'intervention' such as high-dose vitamin D~          supplementation can be shown to be effective in relieving some of the disease burden~          associated with OI, the benefit to OI patients worldwide would be substantial.~   "
102670|NCT01713218|"~     Pancreatic ductal adenocarcinoma (PDAC) has one of the worst prognoses of all human cancers~     and is considered as a sanctuary, resistant to most of the drugs used. Identification of new~     molecular targets involved in its pathogenesis is urgently needed and required both proper~     and innovative efficacy assessment.~      This proof-of-concept trial is studying the dynamic tumor response after the~     administration of a short course (4 weeks) neoadjuvant combination of gemcitabine and a~     Hedgehog inhibitor (Vismodegib) before surgery in patients with operable pancreatic cancer.~   "
102676|NCT01713140|"~     Background:~      Progressive strength training is a training modality used in rehabilitation after total knee~     arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be~     present in the operated leg after TKA, which relates to reduced central nervous system (CNS)~     activation of the muscle. As increased CNS activation occurs during strength training when~     muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this~     also is the case after TKA. The clinical implication is that repetitions performed to~     contraction failure during strength training, may help reduce CNS activation deficits of the~     quadriceps muscle after TKA.~      Purpose:~      The aim of this study is to investigate CNS activation of the quadriceps muscle during~     strength training performed with repetitions to contraction failure after TKA.~      Method:~      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),~     semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions~     performed in a knee extension machine until contraction failure. The relative loading will~     be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is~     defined a minimum of 3 days before the day where the EMG-data are recorded. The primary~     outcomes will be normalized EMG amplitude and median power frequency for each 10th (10%,~     20%, 30% failure, etc.) of the set to failure.~      Hypothesis:~      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,~     the EMG amplitude will increase while the median power frequency will decrease during a~     strength training set performed to contraction failure after TKA.~   "
102677|NCT01713127|"~     The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during~     ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants~   "
102678|NCT01713114|"~     The primary objective of this study is to assess the acute effects of different meals on~     satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings~     of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate~     or meal skipping conditions.~   "
102679|NCT01713101|"~     This study is to see whether the early intravenous administration of tranexamic acid~     improves the outcome of acute upper gastrointestinal bleeding.~   "
102680|NCT01713088|"~     To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth~     offending and out-of-home placement in a large, ethnically diverse, urban U.K. sample than~     an equally comprehensive management protocol; to determine whether MST leads to broader~     improvements in youth sociality and in mediators believed to be responsible for change in~     MST.~   "
102681|NCT01713075|"~     The purpose of the investigation is to confirm the safety and efficacy in long-term use of~     Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the~     post-marketing actual use.~   "
102682|NCT01713062|"~     The purpose of this randomised prospective multicenter longterm study is to evaluate the~     survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked~     polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip~     Arthroplasty.~   "
102683|NCT01713049|"~     The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious~     lesions on mammograms and ultrasound.~   "
102684|NCT01713036|"~     This is a Phase 1, open-label, single centered trial to evaluate the mass balance,~     bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or~     metastatic solid tumors.~   "
102685|NCT01713023|"~     -  BACKGROUND: Individuals with diabetes report innate preference for sweet foods,~          possibly due to genetic variants. In addition, studies have shown that ingestion of~          fructose promotes lower postprandial blood glucose, compared to glucose. However,~          excessive intake may increase triglycerides, uric acid and oxidative stress, due to~          oxidative priority.~        -  AIMS: To investigate the influence of fructose and glucose and taste receptor, type 1,~          member 2 (TAS1R2) in glucose, triglycerides, uremia, oxidative stress, feelings related~          to food intake and palatability of individuals with type 1 diabetes.~        -  METHODS: The trial is a single-blind, two-way crossover (1-week washout) study in 30~          subjects with type 1 diabetes. Blood samples were collected before and 2-hours after~          the participants receive 75g of fructose or 75g of glucose dissolved in 200 ml water.~          Capillary blood glucose were assessed at 30, 90, 120, and 180 minutes to determine~          glucose, and visual analogue scales for measurement of appetite sensation were assessed~          at 70, 120, and 190 minutes.~        -  PURPOSE: The research proposal adds knowledge about the TAS1R2 (Ile191Val) polymorphism~          and around the most suitable monosaccharide for individuals with diabetes type 1.~   "
102686|NCT01713010|"~     The purpose of this study is to evaluate physiological variables to the decision about the~     appropriate time to discontinuation of mechanical ventilation in patients with traumatic~     brain injury. It is expected that these variables are effective in predicting the outcome of~     weaning from mechanical ventilation.~   "
102687|NCT01712997|"~     Previous studies suggest that combinations of existing therapies may be effective for~     pulmonary arterial hypertension (PAH). However, all of these studies are sequential~     combination therapy, for example, by adding sildenafil to previously prescribed bosentan.~     This kind of therapy model is not enough for PAH patients, especially those with New York~     Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the~     investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin~     analog, with the endothelin receptor antagonist bosentan in treatment naive patients with~     PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline~     in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters,~     and time to clinical worsening.~   "
102736|NCT01712347|"~     This multicenter observational study will evaluate the efficacy and safety of first-line~     bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in~     participants with metastatic colorectal cancer (mCRC). Participants for whom the treating~     physician has decided to initiate first-line fluoropyrimidine based chemotherapy in~     combination with bevacizumab will be observed for approximately 4 years.~   "
102846|NCT01710904|"~     This non-interventional, observational study is set up on request of the Belgian~     reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief~     and constipation in daily clinical practice in Belgium compared to the previous analgesic~     treatment with prolonged release oxycodone. Only patients eligible for Targinact®~     reimbursement in Belgium are included.~   "
102688|NCT01712984|"~     The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent~     influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)~     containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent~     influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)~     vaccines in producing protection against four strains of influenza virus.~      Primary Objective:~        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination~          inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is~          non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28~          days post-vaccination.~      Secondary Objectives:~        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by~          HAI GMTs and seroconversion rates) that is superior to the response induced by the~          TIV-ID that does not contain the corresponding B strain.~        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.~        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64~          years), race, ethnicity, gender, previous vaccination status, and baseline~          seropositivity status.~        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.~      Observational Objectives:~        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or~          Grade 3 solicited systemic reactions combined~        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3~          solicited injection site reactions combined.~   "
102689|NCT01712971|"~     The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or~     peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an~     important factor that determines the occurrence of postoperative complications. Therefore,~     any significant reduction of intra-operative blood loss will benefit the peri-operative~     course.~   "
102690|NCT01712958|"~     Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of~     cancer-related death in the world. Despite potentially curative surgery and the use of~     modern adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor~     relapse or metastatic disease. Currently, aside from post-operative pathological staging,~     early follow up of the patients does not include a specific test or any other evaluation~     that could predict disease recurrence. Therefore, exploring and identifying novel biomarkers~     of CRC's following diagnosis of the primary tumor may help us in identifying patients at~     high risk for recurrence.~      Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being~     evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular.~     It has been established, although not completely, that miRNAs have a role in initiation and~     progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the~     expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As~     miRNAs are well documented to regulate critical molecules in signaling pathways, their~     regulation of tumor relevant pathways may also serve to further sub-classify patients into~     drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are~     available as a non-invasive diagnostic method, their application as biomarkers is of special~     interest.~      In this study the investigators aim to quantify miRNA levels in human colon and rectal~     tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of~     patients, the investigators aim to identify specific, relevant miRNAs that may serve as~     biomarkers to stratify CRC patients according to their clinical characteristics such as~     disease stage, specific treatment, prognosis and disease recurrence.~   "
102691|NCT01712945|"~     The purpose of this study is to test a novel strategy to prevent the clinical problem of~     secondary autoimmunity following alemtuzumab treatment of multiple sclerosis.~      The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that~     promotes thymic T cell regeneration (Palifermin, Kepivance®).~   "
102692|NCT01712919|"~     The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation~     against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity~     and efficacy of this new regimen.~   "
102693|NCT01712906|"~     Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which~     occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland~     suppurative swelling and pain with fever. The pathological changes and harm caused by mumps~     was not only confined to the parotid gland, on the contrary, the social harm caused by~     serious complications cannot be ignored. As mumps is a vaccine-preventable infectious~     disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13~     genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain~     of MuV in China was the F genotype. The commonly used vaccine strains represented only a~     small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to~     type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed~     of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A~     strain, which was the first separation and preparation of the attenuated mumps viruses in~     China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition,~     the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is~     much safer to use. The preliminary test results showed that the vaccine possessed good~     immunogenicity and good antigenic cross-reactivity. The application of this vaccine will~     provide more effective means to prevent and control of mumps epidemic.~   "
102694|NCT01712893|"~     The present study is a randomized open-label -phase III study that aims to compare the~     efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application~     of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast~     cancer.~   "
102695|NCT01712880|"~     The purpose of this study is to determine the success rate of two treatments for infection~     after total hip replacement: single stage arthroplasty exchange (your surgeon will take out~     your original implants and replace them with a complete new set) compared to irrigation and~     debridement with modular exchange (your surgeon will clean your implants with a surgical~     solution and take out the plastic liner and replace it with a new one - the rest of your hip~     implants will stay in place). The goal is to see if one is better than the other for the~     treatment of hip infection after a total hip replacement. A successful treatment means that~     you did not have to have another surgery on your hip for an infection-related reason.~   "
102696|NCT01712867|"~     The primary objective is to determine the efficacy of phytosterol esters of omega-3~     (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in~     hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.~   "
102847|NCT01710891|"~     Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard~     laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be~     randomized to have their first intubation attempt done using either standard laryngoscopy or~     the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating~     physician.~   "
102697|NCT01712854|"~     The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate~     (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using~     Optoelectronic Plethysmography (OEP). This study is unique as it will be the first~     randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol~     fumarate dihydrate as the intervention which will evaluate the effects on ventilatory~     mechanics through the use of OEP. The investigators plan to demonstrate that~     budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be~     detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in~     the short term on exercise capacity during a constant load exercise test. The changes in~     ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will~     provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled~     setting also demonstrating the utility of OEP in evaluating of the effects of a medical~     treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD).~        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and~          post exercise spirometry and evaluate exercise dynamic hyperinflation before and after~          treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate~          dihydrate will decrease dynamic hyperinflation as measured by OEP.~        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,~          specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical~          breathing as measured by OEP.~        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state~          exercise and exercise capacity before and after treatment. Our secondary hypothesis is~          that decreases in dynamic hyperinflation during exercise will lead to improvements in~          dyspnea with exercise, and allow for increases in exercise capacity.~        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at~          steady state vs. Borg at end exercise.~   "
102698|NCT01712841|"~     Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in~     developed countries and is often discussed in terms of the dry and the wet forms. The~     wet form of AMD is the more advanced form of the disease and is responsible for 80% of the~     legal blindness in AMD. Treatment options include a promising class of biologics called~     anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.~     These therapies can slow further vision loss, but cannot achieve recovery of lost vision.~     The wet form of AMD is always preceded by the dry form. Therefore, it is reasonable to~     expect that the early detection and treatment of the dry form may help reduce vision loss~     or progression to the more damaging wet form. Unfortunately, symptoms appear only in~     advanced stages of the dry form. As light sensitive cells in the macula breakdown in a~     process called geographic atrophy, the patient may notice blurred central vision.~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,~     except that OCT measures the intensity of reflected light rather than acoustical waves.~      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow~     differ within three severity groupings of non-exudative age-related macular degeneration~     (NEAMD).~   "
102699|NCT01712828|"~     To find out if the blood level of lenalidomide can be changed when a drug that prevents~     p-glycoprotein (a protein naturally present in the body that helps carry substances across~     cell membranes that is found in many parts of the body like the intestines, liver, and~     kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The~     study is also trying to find out if blood level of temsirolimus can be changed when a~     subject takes lenalidomide together with temsirolimus.~   "
102700|NCT01712815|"~     This phase I trial studies the side effects of positron emission tomography (PET)/computed~     tomography (CT) in evaluating response to chemotherapy in patients with breast cancer.~     Comparing results of diagnostic procedures done before, during, and after chemotherapy may~     help doctors predict a patient's response to treatment and help plan the best treatment.~   "
102701|NCT01712802|"~     To establish evidence based guidelines for denture adhesives (powder and cream), multicenter~     cross over randomized clinical trial will be carried out.~      The null hypotheses are that there are no difference on improvement from baseline to post~     application of two adhesives powder and cream, in terms of general satisfaction, oral~     related quality of life, masticatory function and oral conditions.~   "
102702|NCT01712789|"~     The primary purpose of the study is to evaluate the safety and efficacy and to generate PK~     and biomarker data for the combination of pomalidomide and low-dose dexamethasone in~     patients with refractory or relapsed and refractory multiple myeloma.~      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment~     phase and a Follow-up phase which starts within 28 days of discontinuation from study~     treatment, every 3 months for up to 5 years.~      In addition, the collection of steady-state PK data from a large population will enable~     robust population PK and assess Pomalidomide exposure response analyses.~      The exploratory objectives of the study are to investigate potential markers predictive of~     POM response or resistance and pharmacodynamic markers.~   "
102703|NCT01712776|"~     To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in~     decreasing the pain of venipuncture (blood draw)~   "
102704|NCT01712763|"~     The long acting GnRH antagonist degarelix will be tested for the treatment of women with~     endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom~     disappearance and disease free time during follow-up will be the outcomes for establishing~     which medical treatment is the best in endometriosis recurrence treatment.~   "
102705|NCT01712750|"~     Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will~     be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a~     non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to~     determine whether changes in VOT measurements occur in patients during cardiac surgery.~   "
102706|NCT01712737|"~     No studies have reported the effect of pre-meal snacking on raisins compared to other~     commonly consumed snacks on energy intake in children. Therefore, the objective of the~     current study was to examine appetite and energy intake following consumption of ad libitum~     snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on~     appetite and food intake 30 min later in 8 - 11 y old normal weight children. The~     investigators hypothesized that raisins would lower subsequent energy intake in children and~     reduce hunger.~   "
102707|NCT01712724|"~     Both aerobic training (AT) and resistance/strength training (RT) have the potential to~     improve recovery after stroke. Research conducted in chronic disease and healthy populations~     suggest that AT and RT combination therapy may produce synergistic and superior effects~     along cognition and mobility domains, when compared to AT alone. However, the effects of a~     combined training approach (AT+RT) compared to AT alone has not been investigated in people~     post-stroke.~   "
102708|NCT01712711|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat~     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)~     index, and anthropometric measurements (body mass index and waist circumference)in diabetic~     subjects with non-alcoholic fatty liver disease.~   "
102709|NCT01712698|"~     Acute changes in axial diffusivity will correlate with the severity of injury in patients~     that suffer an acute spinal cord injury.~   "
102710|NCT01712685|"~     Background:~      - The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor~     tissue show up more clearly during scans. Researchers want to see how well it works for~     scans for people who have kidney cancer.~      Objectives:~      - To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney~     cancer.~      Eligibility:~      - Adults at least 18 years of age with kidney cancer that will be treated with surgery.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have two positron emission tomography (PET) scans of their kidneys.~          They will have the scans before and after receiving an injection of 18F-VM4-037. The~          scans will take about 2 hours to complete.~        -  About 3 weeks after the PET scans, participants will provide tumor tissue samples from~          their kidneys.~        -  This is a scanning study only. Treatment will not be provided as part of this study.~   "
102711|NCT01712672|"~     Background:~      - Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health~     and diseases such as gingivitis, cavities and periodontal disease. Researchers who study~     plaque know that many different types of oral bacteria stick to each other in test-tube~     experiments. However, it is not clear if these interactions occur in natural dental plaque.~     By studying how bacteria interact, researchers can better understand how bacteria come~     together and grow to form plaque.~      Objectives:~      - To look at how bacteria interact with one another to form dental plaque.~      Eligibility:~      - Healthy nonsmoking volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and dental exam. They will also~          have dental impressions taken for a stent (a device similar to Invisalign(SqrRoot)~          braces).~        -  Participants will wear the stent for up to 8 hours a day on selected study visit days.~          It will contain enamel chips made from sterilized human teeth. The mouth bacteria will~          stick to the chips and grow. Chips will be taken out of the stent twice during these~          study visit days.~        -  Participants will have other study visits to provide saliva and plaque samples. They~          will also have gum swabs to collect bacteria.~        -  Some participants may have a second set of study visits. At these visits, they will~          chew gum to increase their saliva production. Afterwards, they will wear the stent with~          the enamel chips for 4 hours. Samples from the stent will be taken once on these study~          visit days.~   "
102712|NCT01712659|"~     Background:~        -  The human T-cell leukemia virus 1 (HTLV-1 causes adult T-cell leukemia (ATL). Infection~          does not immediately cause ATL, but it can develop over time. ATL is a rare and~          aggressive type of cancer that disrupts the body s ability to control the HTLV-1 virus.~          It also affects the growth and reproduction of cells infected with the virus.~        -  Ruxolitinib is a drug that has been approved to treat bone marrow disorders. It can~          interfere with the proteins that are important to the development and growth of ATL~          cells. Drugs like ruxolitinib may be able to interrupt important activity in ATL cells.~          Researchers want to see if ruxolitinib can be a safe and effective treatment for ATL.~      Objectives:~      - To test the safety and effectiveness of ruxolitinib for adult T-cell leukemia.~      Eligibility:~      - Individuals at least 18 years of age who have ATL caused by HTLV-1.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will take ruxolitinib twice a day for 28 days. They will have blood tests~          on days 1, 14, and 28. These tests will look at the levels of HTLV-1 in the blood.~          Participants will have a final blood test about 2 weeks later. Treatment will also be~          monitored with imaging studies.~        -  Participants who have a partial response during treatment may be able to start taking~          ruxolitinib again after the final blood test. They will continue to take ruxolitinib~          for as long as it is effective and the side effects are not severe.~        -  Participants who have a full response during treatment will take ruxolitinib for 56~          more days, and then stop treatment. If ATL returns, they may restart treatment and~          continue it for as long as it is effective.~   "
102713|NCT01712646|"~     Background:~      - Oxytocin is a chemical that the brain normally produces. It plays an important part in the~     way humans and other animals act in social and emotional situations. Adults with~     schizophrenia have been studied to see if oxytocin can reduce some symptoms of~     schizophrenia, such as hearing voices, feeling suspicious, and not feeling interested in~     daily life. These studies show that oxytocin may help. However, it has not been studied in~     children who develop schizophrenia. Researchers want to see if oxytocin, given as a nasal~     spray, is safe and can reduce schizophrenia symptoms in children.~      Objectives:~      - To see if an oxytocin nasal spray can reduce schizophrenia symptoms in children.~      Eligibility:~      - Children above 10 years of age who have childhood-onset schizophrenia, and have~     schizophrenia symptoms in spite of taking medication.~      Design:~        -  This study will last 4 weeks. Participants will stay in the hospital for the entire~          period of the study. Participants may also have an extra 2 weeks of study medication~          and 1 week of testing immediately following the initial 4 weeks.~        -  Participants will be screened with a physical exam and medical and psychiatric history.~          They will provide blood and urine samples, and have imaging studies of the brain. They~          will also have tests to look at their social and emotional functioning. These tests~          will take 1 week to perform.~        -  Participants will have either oxytocin or placebo nasal spray twice daily for 2 weeks.~        -  At the end of the 2-week period with nasal spray, there will be 1 week with no nasal~          spray. All the tests of week 1 will be repeated.~        -  The optional extra 3 weeks (2 weeks with oxytocin and one week for testing) will be~          similar to the second, third, and fourth weeks of the study. All participants will have~          oxytocin during this period.~   "
102714|NCT01712633|"~     Background:~      - Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series~     of pictures that can be used to look at how the brain processes information. It is used to~     study problems with thinking, language, and movement, among other things. Researchers are~     working to develop new and better fMRI techniques. To test these techniques, they want to~     perform fMRI scans on healthy volunteers.~      Objectives:~      - To test different fMRI techniques in healthy volunteers.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have fMRI scans of the brain. During these scans, they will be asked~          to perform simple tasks. These tasks may involve language, thinking, or motor skills.~          The scanning sessions will last up to 2 hours.~        -  Participants may be asked to return for additional fMRI scans over several years.~   "
102737|NCT01712334|"~     This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate~     the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid~     nebulizer system in patients with cystic fibrosis. Patients who have been receiving~     Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme~     once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will~     then be randomized to receive in a crossover design Pulmozyme once daily for two treatment~     periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated~     time on study treatment is 6 weeks.~   "
102738|NCT01712321|"~     The purpose of this study is to determine whether Vilazodone is effective in the treatment~     of symptoms of Social Anxiety Disorder among adults.~   "
102739|NCT01712308|"~     The goal of this clinical research study is to learn if sotatercept can help to control~     MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.~   "
102848|NCT01710878|"~     Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal~     and occlusive disease of the abdominal aorta.~   "
102715|NCT01712620|"~     Background:~      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a~     rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably~     high. Lung blood vessel function can be harmed by progressive injuries, such as~     inflammation, leading to worsening of the disease. A drug called spironolactone has been~     known to improve blood vessel function and reduce inflammation. Some people with PAH take~     spironolactone to help treat fluid retention. However, its effect on inflammation and blood~     vessel function in patients withPAH is not known. Researchers want to see if spironolactone~     can help these conditions in people with PAH.~      Objectives:~      - To test the effectiveness of spironolactone in treating pulmonary arterial hypertension.~      Eligibility:~      - Individuals at least 18 years of age with pulmonary arterial hypertension.~      Design:~        -  This study will last for 24 weeks. Participants will be screened with a physical exam~          and medical history. Blood and urine samples will be collected.~        -  Participants will take either spironolactone or a placebo. They will take their study~          drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests.~        -  In Week 8, participants who have had no reaction to the treatment will receive a higher~          dose of the drug or placebo.~        -  In Week 12, participants will have a study visit with heart and lung function tests.~          They will also have a 6-minute walk test, and provide blood and urine samples.~        -  After additional study visits for blood samples, participants will have a final visit~          in Week 24. The tests from Week 12 will be repeated at this visit.~   "
102716|NCT01712607|"~     Background and Objectives: All modern surgical procedures require a high level of cognitive~     and psychomotor skills achieved using different training methods, but could be influenced by~     fatigue and other psychological factors. We evaluate the effect of warm-up exercises on~     operative laparoscopic performances in gynecologic laparoscopic procedures.~      Methods: The surgical team operates on a consecutive series of 20 patients and perform~     laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to~     be operated on without warm-up exercises and group B to be operated on after a short-term~     warm-up. All patients are operated on by the same surgical team. The full-time records of~     the operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded~     and assessed by 2 independent observers using the generic OSATS rating scale. A training~     module using the Lap Sim simulator was designed for the warm-up.~   "
102717|NCT01712594|"~     Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor~     glucose readings when making their insulin dosage decisions. Designing a computerized system~     that mimics the way insulin is produced naturally in a person who does not have type 1~     diabetes holds many challenges; all of which cannot be addressed in just one study. The~     purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a~     system designed to automatically infuse the correct insulin dose during the hours that the~     patient is sleeping.~      The system consists of an insulin pump that provides insulin to the patient through an~     infusion set. A sensor inserted just under the patient's skin measures glucose levels and a~     transmitter sends this information to the pump. To enable the sensor to register the glucose~     information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times~     a day. In the commercially released system, the physician would recommend the continuous~     background (basal) insulin rates and the patient would be required to make decisions~     regarding extra insulin (bolus) for meals or as a response to high glucose levels.~      In the Closed Loop System, a mobile control system is added to these devices. This consists~     of an Android phone, a closed loop algorithm and a translator. This system is designed to~     translate the sensor information and direct the pump to provide the required dosage of~     insulin automatically without requiring input from the patient.~      Reliable calibration has proved challenging, and so it is important that the system function~     safely, even when calibration is inaccurate. In this study, a calibration error will be~     introduced under very controlled circumstances. This testing will identify if the system can~     maintain acceptable overnight glucose levels, regardless of whether or not calibration is~     ideal.~   "
102718|NCT01712581|"~     T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial~     tissue content (water, fibrosis, iron).~      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in~     healthy volunters aged 18-69 years using 1.5T clinical MRI.~   "
102719|NCT01712568|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the~     clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in~     each period. After maintaining at least 10 hours of overnight fast Test or Reference product~     was administered orally (as per the randomization schedule) to each subject with about 240~     mL of water at ambient temperature in each period by trained study personnel.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples~     were collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00,~     9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study~     period with a washout period of 7 days between the dosing of two periods. Subjects were~     continuously monitored for well being i.e., blood pressure, radial pulse and oral~     temperature before check-in, prior to drug administration and at regular intervals post dose~     in each period. The concentration of Ropinirole in plasma samples obtained from study~     subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical~     analyses were performed on obtained drug concentration data, using appropriate software.~   "
102720|NCT01712555|"~     After people lose an eye, for whatever reason, they often experience fat atrophy of the~     tissues in the orbit. This leads to a sunken appearance that is often not correctable by a~     cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/~     invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own~     disadvantages. This study seeks to demonstrate an improvement in the retention of injected~     autologous fat by mixing in autologous PRP (platelet rich plasma).~   "
102721|NCT01712542|"~     Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma~     patients.~   "
102722|NCT01712529|"~     The purpose of this study is to evaluate the effect of supervised physical exercise on~     endothelial function and number of endothelial progenitor cells (EPCs) in patients with~     systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise~     on endothelium derived growth factor (VEGF) levels, disease activity, quality of life,~     fatigue, perceived exertion and cardiopulmonary exercise test variables.~   "
102723|NCT01712516|"~     This study will assess the efficacy, safety and tolerability of indacaterol~     maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.~   "
102756|NCT01712087|"~     This post-approval study will primarily evaluate the long-term safety of the MedStream~     Programmable Infusion System when used in combination with Baclofen for the treatment of~     severe spasticity. A secondary objective, to assess long-term effectiveness, based on the~     observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm~     Scores over the 36-month follow-up period will also be described.~   "
102724|NCT01712503|"~     This is a randomised controlled trial that formally compares intra-ocular lenses, which can~     be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is~     the newer toric lens which can correct astgimatism.~      The null hypothesis is that both intra-ocular lenses give the same visual outcome in~     cataract surgery. The alternative hypothesis is that the toric lens, provides a better~     unaided (without glasses) vision, by correcting the participant's astigmatism.~      It has been decided to conduct a randomised controlled trial of the two lenses, as although~     the toric lenses are endorsed by many case series (which show a reduction in astigmatism),~     they have not been formally compared to the standard lens. An RCT will enable the formal~     comparison.~      It is expected that this trial will take approximately a year to conduct: six months of~     recruitment and six months of follow-up. A further six months will be required to analyse~     the data and prepare a manuscript for publication.~      The investigators do not plan to conduct an interim analysis or report as this is a~     short-trial (six months follow-up) using two alternative lens that are CE marked and already~     widely used.~      Participants who have both cataract and astigmatism will be identified from the~     GP/optometrist referral letter. They will be seen in specially designated clinics for this~     research study, which will run alongside the routine cataract 'one' stop clinics at St~     Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be~     part of the study to have all the necessary examination done in one visit and for those who~     decline participation to be seen in the regular cataract clinic. Potential participants will~     be sent the research trial information (appendix A) with their appointment letter.~      After introducing himself the researcher (who is also a senior cataract surgeon at Western~     Sussex Hospital Trust), will check if potential participants have had the opportunity to~     read the trial information that they were sent, or give participants a further copy as~     required. The key points of the trial will be re-iterated by the researcher and they will be~     invited to ask any questions about the trialThe researcher will check that the potential~     participant has read and understood the participant information leaflet. They will answer~     any questions that the potential participant has and will then take signed consent from~     those willing to participate.~      Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with~     bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the~     participant prefers, after consultation with the researcher or surgeon, to have operated~     first. The participant will be allocated a unique study reference number.~      Patients who decline to take part in the trial will be offered cataract surgery as per usual~     WSHT/NHS procedure.~   "
102725|NCT01712490|"~     This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of~     comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin~     (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated~     A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and~     dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)~   "
102726|NCT01712477|"~     This is a prospective randomized controlled pilot study in traumatic brain injury (TBI)~     patients who are sedated with either propofol or midazolam to compare the cytokine response~     and neuropsychological outcomes with and without elevated blood alcohol levels.~      Sedation is part of the standard treatment in patients with a TBI and has been proposed as a~     neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam~     and propofol, are not standardized and it is unclear whether sedation has a significant~     impact on recovery and outcome. A review of propofol versus midazolam in mechanically~     ventilated patients shows evidence that both provide effective sedation but there is lack of~     data to support one sedative over the other.~      Cytokines are released in response to tissue injury and act to generate a variety of~     physiologic responses. The cytokine elevation has been correlated with the extent of tissue~     injury. This study will compare the cytokine distribution patterns at specific posttraumatic~     time points in patients with a TBI sedated with either propofol or midazolam. Additional~     analysis will compare the cytokine response in patients whom had elevated blood alcohol~     levels with those with normal levels. Neuropsychological testing will also be performed to~     determine the extent of brain injury and recovery.~   "
102727|NCT01712464|"~     This study aims to examine the modulation of neuronal and behavioural parameters of social~     reinforcement learning.~   "
102728|NCT01712451|"~     Dose ranging study~   "
102729|NCT01712438|"~     Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated~     patients with severe Hemophilia A.~   "
102730|NCT01712425|"~     The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1~     proteome into one chimaeric protein. This gene has been inserted into 2 leading~     non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63)~     and a modified vaccinia virus Ankara (MVA) to construct the ChAdV63.HIVconsv and~     MVA.HIVconsv HIV-1 candidate vaccines. The present study is named ChAd-MVA.HIVconsv-BCN01~     and it is a phase I, multicenter primary/booster therapeutic vaccination study to evaluate~     the safety and immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered~     intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected~     individuals with early viral suppression 6 months after initiation of~     Tenofovir/Emtricitabine plus Raltegravir.~   "
102731|NCT01712412|"~     The objectives of this study are to determine the safety and efficacy of IW-9179~     administered to patients with functional dyspepsia (FD).~   "
102732|NCT01712399|"~     A clinical study to investigate the safety of mavrilimumab, an antibody being developed for~     the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that~     affects the joints.~   "
102733|NCT01712386|"~     Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced~     exercise capacity. This is because their lungs are damaged and because of increased work of~     breathing. In some patients, exercise capacity is reduced to such a level that even simple~     activities of daily living, such as washing and dressing, may impose a challenge.~      Recent findings in healthy young people suggest that increasing the amount of nitrate in our~     diet in the form of beetroot juice can improve the ability to exercise. Studies involving~     cycling have shown that less oxygen is needed to perform the same level of exercise after~     taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be~     converted in the body to nitric oxide (NO), a substance which increases blood flow and may~     affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is~     that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to~     complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of~     this study to see if such effects could be seen in COPD patients. If this is indeed the~     case, then it may suggest that a period of dietary supplementation of a relatively cheap,~     widely available, and natural food product may improve the ability of patients to undergo~     everyday tasks and ultimately improve their quality of life.~      To help investigators understand the effects of dietary nitrate supplementation on the~     ability to exercise in COPD patients, the investigators will recruit 15 people with mild to~     moderate disease. They will complete a series of undemanding exercise tests on three~     separate occasions. On one occasion they will have had a course of nitrate rich beetroot~     juice leading up to the tests, and on the other occasion they will have had a course of~     beetroot juice with the nitrate removed. The investigators will monitor blood pressure,~     levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the~     tests which will allow us to assess any effects that may have occurred as a result of~     increased nitrate intake.~   "
102734|NCT01712373|"~     The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of~     fatigue and Quality of Life of MS patients.~   "
102735|NCT01712360|"~     This study is being done to see how the body is affected when a study drug is applied to~     both feet if the subject has athlete's foot or to both feet and the groin area if the~     subject has both athlete's foot and jock itch. Safety of the drug and how well the drug~     works will also be measured.~   "
102830|NCT01711125|"~     To explore the effectiveness and biobehavioural basis of baclofen in improving treatment~     outcomes for alcohol dependence in people with alcoholic cirrhosis in a double-blind~     randomised placebo-controlled trial.~   "
102740|NCT01712295|"~     Plantar warts on the sole of the foot are among the most common warts seen in podiatry~     clinics. Some patients are readily cured by simple standard of care treatments that include~     wart debridement (trimming or excision) and application of 17% salicylate (commercially~     known as Compound W)or by other treatments that may be painful and affect mobility. No~     treatment is consistently effective and most patients fail treatment multiple times.~      Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that~     may improve the activity of salicylate in wart treatment by improving the ability to~     penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may~     improve cures of common foot plantar warts in subjects who also be receiving other~     standard-of-care treatment.~   "
102741|NCT01712282|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of the optimal dose of physical activity in stroke patients immediately after~     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation~     as well as the optimal dose of physical rehabilitation is of great importance for many~     patients, their relatives as well as of a great socioeconomic importance.~      The purpose of the project is to investigate feasibility of treadmill training on a~     weight-bearing treadmill in the acute phase after admission after an ischemic stroke.~     Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and~     whether it changes with treadmill training.~   "
102742|NCT01712269|"~     The central aim of this research project is to determine how the ever-growing problem of~     obesity in the western world contributes to the pathophysiology of obstructive sleep apnea~     (OSA). To complete this aim, the investigators will determine the impact of obesity on the~     mechanisms underlying OSA. This will be achieved by making physiological measurements of 4~     physiological traits known to cause OSA as well as the patients sleep apnea severity, before~     and after weight-loss surgery (i.e. bariatric surgery).~   "
102743|NCT01712256|"~     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced~     immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV~     immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.~      All patients participating in this trial have previously received the vacc-4x vaccine in~     order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The~     primary objective of this study is to evaluate if a re-boost with Vacc-4x could further~     reduce the amount of HIV-1 virus and increase the immune response.~   "
102744|NCT01712243|"~     The purpose of this study is to determine whether specific wavelengths of light at night can~     be used to improve mobile balance while simultaneously not increasing alertness.~   "
102745|NCT01712230|"~     This study is designed to determine whether a reduction in hormones (such as occurs during~     menopause) causes a decrease in calories burned during physical activity. This study will~     also determine whether a reduction in hormones decreases calories burned while sleeping,~     resting, and eating and whether an exercise intervention can prevent this.~   "
102746|NCT01712217|"~     The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in~     Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.~   "
102747|NCT01712204|"~     Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to~     mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the~     inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis~     of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β~     inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target~     for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis~     with good safety record and very few contraindications to the co-morbidities commonly among~     gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in~     clinical trials. The favorable product profile of AC-201 overall provides a strong rationale~     for investigating its clinical utility as prophylaxis against flares when initiating ULT.~   "
102748|NCT01712191|"~     This is a prospective, multi-center, open label, non-randomized study, evaluating the~     treating of medial meniscus deficiency with the NUsurface Meniscus Implant.~   "
102749|NCT01712178|"~     A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for~     pharmacodynamics, pharmacokinetics, and safety.~   "
102750|NCT01712165|"~     The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk~     product) over a 12-week period increases red blood cell folate concentrations in women of~     childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)~     milk.~   "
102751|NCT01712152|"~     Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet~     muscles, but they may develop a poor heart function due to the involvement of the heart~     muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only~     after the heart has already become weaker. Cardiac magnetic resonance tomography can detect~     myocardial fibrosis already at preserved heart function and may facilitate early therapy. In~     our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests,~     EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to~     assess the extent of cardiac affection and its association with the clinical development.~   "
102752|NCT01712139|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.~   "
102753|NCT01712126|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions~   "
102754|NCT01712113|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan 300 mg Tablets under fasted conditions~   "
102755|NCT01712100|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan 300 mg Tablets under fed conditions.~   "
102757|NCT01712074|"~     This study will evaluate safety and efficacy of PF-05212377 in subjects with~     mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable~     dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment~     period is considered the minimum length necessary to reliably evaluate the effect~     PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week~     washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.~   "
102758|NCT01712061|"~     The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects~     with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a~     surrogate for improved glomerular filtration.~   "
102759|NCT01712048|"~     The aim of this study is to compare the efficacy and safety of two standard methods of~     polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection~     (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal~     polyps.~   "
102760|NCT01712035|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic~     white Americans. Neovascular AMD is an advanced form of macular degeneration that~     historically has accounted for the majority of vision loss related to AMD. The presence of~     choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.~     Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying~     fibroblasts from the choroid perforating Bruch's membrane with extension either above or~     below the retinal pigment epithelium. These neovascular complexes are associated with~     hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and~     vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular~     endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of~     choroidal neovascularization and to reduce vascular permeability.~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,~     except that OCT measures the intensity of reflected light rather than acoustical waves.~      This observational study will use OCT technology to study and compare the retinal and~     choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment~     naïve group and active treatment group.~      The purpose of this study is to assess the utility of OCT angiography in the evaluation of~     NVAMD.~   "
102761|NCT01712022|"~     Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of~     the study is to evaluate the accuracy and repeatability of the epithelial thickness~     measurement. Consented subjects will undergo a series of cornea measurements using optical~     coherence tomography (OCT) that will be used for analysis.~   "
102762|NCT01712009|"~     The primary objective of the study is to estimate the difference in bone pain between breast~     cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic~     intervention, prophylactic naproxen, or prophylactic loratadine.~   "
102763|NCT01711996|"~     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be~     related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction~     (UPJO) patients. We are trying to analyze whether it is related with the grade of renal~     injury in UPJO patients.~   "
102764|NCT01711983|"~     The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and~     efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum~     atrial septal defects (ASDs). The data obtained in this study will evaluate this next~     generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®~     Septal Occluder.~   "
102765|NCT01711970|"~     This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the~     safety and tolerability of the combination of intravenous administration of VB-111 and~     paclitaxel in patients with platinum resistant ovarian cancer.~   "
102766|NCT01711957|"~     Recent experimental and clinical studies have shown that platelets play a critical role in~     liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious~     condition in liver transplantation (LT) recipients, was shown to be associated with~     postoperative morbidity and mortality after partial hepatectomy.~      The investigators aim at evaluating whether postoperative low platelet counts are indicators~     of short- and long-term outcomes after liver transplantation.~   "
102767|NCT01711944|"~     Parents of children newly diagnosed with cancer experience depression and anxiety,~     especially in the first several months of treatment. Bright IDEAS, an 8-session~     problem-solving skills training (PSST) program has been used in studies with more than 900~     mothers including more than 125 monolingual Spanish-speaking mothers. It has been shown to~     significantly decrease mothers' distress and to particularly benefit Latina immigrants. This~     past spring, the NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program~     and has included it in the National Registry of Evidence-based Programs and Practices. To~     date, Bright IDEAS has been available to mothers at only a few cancer centers with specially~     trained personnel. This proposal is designed to bring Bright IDEAS on-line to make it~     available to mothers and fathers 24/7 anywhere with Internet access. The investigators will~     carefully analyze acceptability and use to gain insight into the most promising ways of~     disseminating interventions like Bright IDEAS using Internet, Internet II, and other~     emerging technologies.~   "
102768|NCT01711931|"~     The purpose of this study is to compare the efficacy and safety of everolimus- and~     biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.~      The null hypothesis to be rejected is that there is no significant difference with regard to~     lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR~     at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting~     bioresorbable vascular scaffold stents.~   "
102769|NCT01711918|"~     To provide oral domperidone to patients between the ages of 18 and 60 years of age,~     according to the investigator's judgment, a prokinetic effect is needed for the relief of~     severe gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying~     scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal~     pain. We will recruit patients for two years and the patients will be given domperidone for~     up to two years.~   "
102770|NCT01711905|"~     The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per~     day for 12 weeks can be used to normalize vitamin d-Status~   "
102771|NCT01711892|"~     Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced~     Prostate Cancer (PC).~      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease~     in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk~     of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.~      Numerous studies have shown an association between physical activity, physical capacity and~     quality of life in cancer patients and recent epidemiological research suggest that regular,~     moderate-intensity physical activity may have a positive effect on survival in men with~     prostate cancer.~      Within exercise physiology there is new evidence pointing to recreational soccer as a unique~     form of intermittent exercise that effectively stimulates aerobic and anaerobic energy~     delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular~     adaptations of importance for health.~      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per~     week will improve the health profile of PC patients receiving ADT treatment.~   "
102772|NCT01711879|"~     This 52 week study will assess the use of intravitreal aflibercept injections in patients~     with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.~      The investigators hypothesize that the neovascularization of the iris and angle present in~     neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept~     injection alone and result in increased comfort and preservation of visual field as compared~     to current standard of care utilizing pan-retinal photocoagulation. The advantages to~     intravitreal aflibercept injection use could include resolution of NVI/NVA~     (neovascularization of the iris/neovascularization of the angle) leading to quicker pain~     relief and quicker lowering of IOP (intraocular pressure).~   "
102773|NCT01711866|"~     The purpose of this study is to assess the safety and feasibility of switching subjects with~     advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess~     the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects~     switched from previous treatment with either Pramipexole or Ropinirole.~   "
102774|NCT01711853|"~     The study to be conducted is a prospective, open label trial. It is designed to evaluate the~     pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran~     etexilate in patients with chronic kidney disease.~   "
102775|NCT01711840|"~     The purpose of the investigation is to confirm the safety of patients receiving Symbicort~     Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing~     actual use.~   "
102776|NCT01711827|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of prednisolone after single dose administration of prednisone. This study~     will also assess the safety and tolerability of isavuconazole alone and in combination with~     prednisone.~   "
102777|NCT01711814|"~     The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in~     subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA~     study.~   "
102778|NCT01711801|"~     This randomized, Investigator/Subject-blind, adaptive single-ascending-dose,~     placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics~     (including the effect of food), and pharmacodynamics of RO5545965 following oral~     administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts~     to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive~     2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout~     period of approximately 2 weeks between treatment periods.~   "
102779|NCT01711788|"~     The purpose of this study is to determine if the method of intrabone infusion of hematologic~     stem cells can increase and accelerate hematopoietic reconstitution after umbilical cord~     blood transplantation in pediatric patients.~   "
102780|NCT01711775|"~     This single-center, non-randomized, open-label study will assess the pharmacokinetics of~     aleglitazar after administration of single and multiple oral doses in healthy Chinese~     volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated~     oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening~     and a 2-week follow-up, is up to 8 weeks.~   "
102781|NCT01711762|"~     This open-label, non-randomized study will assess the absorption, metabolism, and excretion~     of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a~     single dose of [14C]-GDC-0973.~   "
102782|NCT01711749|"~     This is an open-label, randomized, two treatment, two sequences, two periods crossover~     study, using a crossover 2x2 design, where each subject will be randomly assigned to~     reference or test formulation, in order to evaluate if both formulations are bioequivalent.~   "
102783|NCT01711736|"~     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of~     the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed~     vaccine Fluarix® (TIV) in young children 6 to 35 months of age.~   "
102784|NCT01711723|"~     In accordance with the recently revised FDA draft renal impairment guidance (March 2010)~     which advises the conduct of renal impairment study in drugs that are not predominately~     eliminated through the renal route, the proposed study will be conducted to formally assess~     the pharmacokinetics (PK) of darapladib in severely renally impaired subjects.~      In this is an open-label, non-randomized study eight subjects with severe renal impairment~     will be recruited along with 8 healthy control subjects matched to the severe renal~     impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or~     minus 10 years).~      All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10~     consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and~     tolerability will be evaluated.~      All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check~     out of the clinic on Day 2 after all assessments are complete, but must return to the clinic~     each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic~     again on the evening of Day 9. After the last dose of the study drug, there will be a~     follow-up period which will include 2 visits (Day 20-24 and Day 38-52). The total study~     duration for each subject including the screening, treatment and follow-up periods will be~     approximately 11 weeks.~   "
102785|NCT01711710|"~     The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled~     Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or~     augmentation~   "
102786|NCT01711697|"~     This phase I trial studies the best dose of radiation therapy in treating patients with~     locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation~     therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as~     stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly~     to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been~     shown to provide excellent results when used in early stage lung cancer, but has not yet~     been applied to patients with more advanced disease.~   "
102787|NCT01711684|"~     Melanoma is a life-threatening cancer which poses a significant health burden, especially~     when metastatic or spreading to areas other than the original tumor growth. Although various~     treatment options are currently available for melanoma, melanomas that have metastasized~     widely to the skin pose a significant clinical challenge as the available therapies have~     limited effect. This study proposes the use of a topically applied compound named~     diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma~     patients whose diseases have spread widely throughout the skin. DPCP works by having a~     patient's own immune system, which is usually used to fight infections, attack cancerous~     cells. This compound has commonly been used to treat other conditions such as warts and hair~     loss throughout the world for many years and is known to cause limited side effects.~     Altering a patient's own immune system through topical treatments has also been shown to~     benefit patients with other cancers that have metastasized to skin such as breast cancer. In~     this study, the investigators will use DPCP to treat cutaneous metastases of various cancers~     including melanoma. Our overall intention is to get a better understanding of effective~     immune responses in the skin that may mediate metastatic cancer regression or cure.~   "
102788|NCT01711671|"~     A study to evaluate the safety, efficacy and bone changes with combination therapy of~     intravenous (IV) infused DKN-01 and lenalidomide/dexamethasone, versus lenalidomide and~     dexamethasone in relapsed or refractory multiple myeloma (MM) patients~   "
102789|NCT01711658|"~     PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of~     radiation therapy plus cisplatin in patients who have head and neck cancer that is not~     related to the HPV virus.~   "
102790|NCT01711645|"~     Monitoring immune response and longevity in serum and milk after Tdap administration to~     postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just~     delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at~     Vanderbilt University Medical Center. The enrollment period will be fifteen months. The~     duration is over two years of observation.~   "
102791|NCT01711632|"~     The purpose of this study is to find out what effects, good and/or bad, treatment with~     vemurafenib (also known as Zelboraf™) has on the patient and on leukemia. Specifically, the~     researchers want to know how well vemurafenib eliminates leukemia from the blood.~   "
102792|NCT01711619|"~     The purpose of this study is to compare the effectiveness of peripheral nerve stimulation~     utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management~     (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery~     Syndrome (FBSS).~   "
102793|NCT01711606|"~     This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to~     evaluate characteristics, management and patient and caregiver-related outcomes the quality~     of life of Families and patients with FXS and to collect epidemiological and health economic~     data.~        -  EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X~          syndrome~        -  Characterisation of the phenotype of FXS patients~        -  Description of patient characteristics (demographics, family history, comorbidity,~          education, working situations, care situations, insurance status)~        -  Documentation of therapeutic interventions~        -  Recording and assessment of psychosocial parameters (possibly also inclusion of family~          members, carers)~        -  quality of life of the carer and if possible the patient~        -  Health economic parameters and consumption of resources~   "
102794|NCT01711593|"~     Despite advances in medications, allergic diseases, including allergic asthma continue to~     rise in prevalence. For this reason, there is a need for a better understanding of the~     mechanisms of allergic diseases and novel insights into modulating allergic inflammation.~     The investigators hypothesize that much remains to be learned about the behavior of T~     effector and T regulatory cells in allergic disease. Furthermore, the investigators~     hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these~     mechanisms may provide insights into novel therapeutic strategies to control allergic~     diseases. The investigators will investigate the capacity for T cell tolerance induction in~     allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The~     investigators will assess whether in vitro generated it-DCs have the capacity to induce~     antigen-specific T regulatory cells and suppress allergen-specific T effector cell function~     in vitro.~      Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes~     in the airways that occur during exposure to allergen. For this investigation, the route of~     administration will be topical application of the titrated allergen to a bronchoscopically~     isolated subsegment of one lobe of one lung. The dose of biologic will be determined from~     prior skin-prick testing.~   "
102795|NCT01711580|"~     Patients with a high grade glioma have an increasing overall survival and progression free~     survival after initial treatment. Because of a better performance status these patients are~     more often eligible for re-treatment with for example radiotherapy. However, to date only a~     few prospective studies on re-irradiation of gliomas exist and very little is known about~     the effects of re-irradiation on quality of life and cognition. This trial is designed to~     longitudinally establish the effects of re-irradiation on quality of life, cognition and~     physical performance in patients with a high grade glioma. Based on the currently available~     information the investigators hypothesize that quality of life after re-irradiation can be~     kept stable until further tumour progression.~   "
102831|NCT01711112|"~     Based on the previous clinical experience in other cancers, and considering the absence of~     current standard salvage regimens, the single agent docetaxel is selected as the regimen for~     this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe~     myelosuppression observed in other cancer trials warrants further study in urothelial~     cancer. The objective of the study is to evaluate the safety and activity of weekly~     docetaxel given as salvage therapy for advanced urothelial cancer.~   "
102796|NCT01711567|"~     Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic~     hepatitis B patients. However, about 20% of patients showed partial virologic response after~     2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients).~     Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there~     is no cross resistance between the two drugs. Therefore it is assumed that tenofovir would~     be effective in the treatment of chronic hepatitis B patients who shows partial virologic~     response (detectable HBV DNA by real time PCR after 12 months of treatment) despite~     treatment with entecavir. In this study, we will compare the efficacy of switching to~     tenofovir with continuing entecavir in patients who shows partial virologic response to~     entecavir.~   "
102797|NCT01711554|"~     This phase I trial studies the side effects and best dose of lenalidomide when given~     together with dinutuximab with or without isotretinoin in treating younger patients with~     neuroblastoma that does not respond to treatment or that has come back. Drugs used in~     chemotherapy, such as lenalidomide and isotretinoin, work in different wants to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may interfere with~     the ability of tumor cells to grow and spread. Giving more than one drug (combination~     chemotherapy) together with dinutuximab therapy may kill more tumor cells.~   "
102798|NCT01711541|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     veliparib when given together with combination chemotherapy and to see how well they work in~     treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as~     docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether combination chemotherapy is more~     effective when given with or without veliparib in treating head and neck cancer.~   "
102799|NCT01711528|"~     This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when~     given together with dexamethasone in treating patients with multiple myeloma that has~     returned after a period of improvement. Dinaciclib and bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer~     cells.~   "
102800|NCT01711515|"~     This phase I trial studies the side effects and best dose of ipilimumab when given after~     chemoradiation therapy in treating patients with cervical cancer that has spread to nearby~     tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to~     kill tumor cells and shrink tumors. Monoclonal antibodies, such as ipilimumab, may find~     tumor cells and help carry tumor-killing substances to them. Giving ipilimumab together with~     chemoradiation therapy may be a better way treat cervical cancer.~   "
102801|NCT01711502|"~     This is a multicenter, national, retrospective chart-review study that will be based on the~     collection of data from electronical or paper-based medical records with available data on~     female patients diagnosed with metastatic brest cancer . The main purpose of this study is~     to provide accurate, evidence based description on the incidence of progression of~     metastatic breast cancer and its clinical management.~   "
102802|NCT01711489|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration.~     Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.~   "
102803|NCT01711476|"~     The objective of this study is to investigate the effects of two isocaloric maintenance~     diets with different meal timing distribution on insulin resistance hyperandrogenism and~     cytochrome P450c17 alpha activity in lean PCOS women.~      The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist~     in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high~     calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to~     OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.~   "
102804|NCT01711463|"~     In this study, fluticasone furoate (FF) and vilanterol (VI) in different dose combinations~     (50/25mcg, 100/25mcg and 200/25mcg) will be administered from a single dry powder device to~     evaluate the PD, PK, safety and tolerability of the combination in healthy Chinese subjects.~     The information gathered will be used as a support of the clinical development program of~     the fixed dose combination of FF/VI inhalation powder in Chinese population.~   "
102805|NCT01711450|"~     This study is aimed at assessing whether performing a paravertebral block (a type of~     regional pain relief) can reduce the pain and anxiety patients experience during~     radiological procedures on the liver.~   "
102806|NCT01711437|"~     THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT~     BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN.~      THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING~   "
102807|NCT01711424|"~     This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine~     clinical setting. Treatment decisions are made by the physician and reflect the physician's~     current standard of care.~   "
102808|NCT01711411|"~     The study will measure the incidence of moderate and severe adverse events (AEs) associated~     with PrePex procedures, including both procedural and post-procedure events, and all~     device-related incidents such as dislodgment. To assure complete ascertainment of AEs,~     study-specific forms will be used to collect standardized data from the circumcision visit~     and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will~     revert to routine practice (two follow-up visits) for the remaining 375 cases.~   "
102832|NCT01711099|"~     Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial~     Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial~     ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina~     pectoris.~   "
102809|NCT01711398|"~     The experimental plan will consist in:~      The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the~     optimal and recommended dose of IPP-204106N using a Bayesian with memory design with~     combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of~     three patients. The Bayesian methodology allows updating information as the trial progresses~     and stopping the trial as soon as the information obtained is deemed to be sufficient.~     Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I~     clinical trial with N6L will be used to inform the prior distribution in the present study.~      The decisional part, according to the results of the phase I portion of the study, will~     define the optimal dose recommended for the phase IIa portion of the study.~      The phase IIa portion of the study will confirm the optimal dose, and is designed to~     evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient~     population treated at the recommended dose of IPP-204106N.~   "
102810|NCT01711385|"~     In an ongoing study new dental patients are screened to determine their risk of having~     undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and~     signs of gum disease. Investigators further seek to assess if a post-identification~     intervention leads to a greater likelihood of study participants identified as potentially~     pre-diabetic or diabetic visiting their physician regarding their screening blood test~     results, and to improved health outcomes.~   "
102811|NCT01711372|"~     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and~     provide little information about accessory movements in response to a stimulus. One in ten~     children, ages 5 to 17, has been diagnosed with ADHD.~      Tests such as the Conners' Rating Scale require subjective responses from parents and~     teachers, making coordination difficult. The computerized Conners' Continuous Performance~     Test (CPT) provides objective data in regards to inattention and impulsive patterns of~     response. However, it does not provide data regarding accessory movements such as~     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the~     exam has a reading disorder, it will impair his or her ability to respond accurately and it~     will increase response time. The T.O.V.A. is another computer based test used as a~     diagnostic aid for ADHD, which uses a microswitch to record responses. It does utilize~     auditory and visual stimuli, which removes the reading level limitation. However, it is~     unable to measure to measure accessory movements that may be contributing to reaction time~     and errors of omission and commission.~      Because of these limitations, a new company called CogCubed has created a new game based on~     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are~     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact~     with one another. CogCubed is providing the data for this study. The game will be played in~     a 30 minute sessions by subjects ages 6-17. Subjects recruited to play the game will be~     those with ADHD and those without, matched by gender and age. Those with comorbidities of~     developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and~     substance use disorders will be excluded, as well as any physiological disability that~     affects upper limb movement and/or coordination. Informed consent will be obtained from~     parents and patient prior to administering the game. Parents will fill out a Conner's Brief~     Rating Scale and a Conner's Brief Rating Scale, Teacher's version will also be supplied to~     be filled out at school.~      The hypothesis is that by analyzing data generated from this new gaming platform named~     Sifteo for which a game was created, which uses auditory and visual stimuli and distracters,~     the investigators expect that they will be able to provide a more accurate profile of~     impulsivity and inattention. The investigators expect that inattention will have more errors~     of omission and less tilt movements than control and impulsivity will be represented as more~     commission and greater tilting movements than control. This trial builds on the previous~     results of our phase 1 trials used to create the predictive algorithms to analyze the data~     and predict the likelihood of ADHD diagnosis based on patterns of game play behavior.~   "
102812|NCT01711359|"~     The purpose of this study is to determine whether baricitinib therapy alone is noninferior~     to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid~     arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other~     conventional or biologic disease-modifying antirheumatic drugs (DMARDs).~   "
102813|NCT01711346|"~     The objective of this study is to assess the post-infusion viability of S-303 Red Blood~     Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs~     prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to~     conventional untreated RBCs stored for 35 days.~   "
102814|NCT01711333|"~     This study is to evaluate symptomatic changes and safety before and after the administration~     of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with~     peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).~   "
102815|NCT01711320|"~     In this study, investigators hypothesized that the plasma concentration of metformin and its~     glucose-lowering action would be affected by omeprazole, probably by altering the expression~     or function of OCTs in the liver, its primary target organ, as well as in the kidney.~   "
102816|NCT01711307|"~     The proposed trial is a multi-centre prospective randomized controlled trial comparing~     outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or~     with open operative tendon repair. All patients will undergo accelerated functional~     rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.~   "
102817|NCT01711294|"~     To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic~     cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard~     diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of~     mucinous (pre-malignant) and non-mucinous cysts.~   "
102818|NCT01711281|"~     Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major~     cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for~     synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters,~     physical capacity and quality of life. A continuous measurement of the left-ventricular~     volume would provide information about heart performance and could be used for both heart~     failure monitoring and optimization of CRT-therapy.~   "
102819|NCT01711268|"~     Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is~     50mg, but many patients require a dose decrease due to side-effects. Drug levels of~     sunitinib vary approximately 10-fold between patients.~      This study will measure blood levels of sunitinib and its metabolite, and correlate these~     with side-effects and the response to the treatment. The study aims to establish whether~     blood levels change with time, and see how useful blood levels are for monitoring patients~     treated with sunitinib.~   "
102820|NCT01711255|"~     Recent research in multiple sclerosis (MS) have suggested that altered coagulation and~     vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic~     method of analyzing clot formation. This instrument will be used to compare coagulation in~     individuals with MS to healthy controls. A 24-hour dietary recall and food frequency~     questionnaire will help determine whether coagulation is modified by fish consumption.~   "
102821|NCT01711242|"~     The objective of the trial is to compare disease-free survival between adjuvant XELOX alone~     vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer~     patients with D2 dissection.~   "
102822|NCT01711229|"~     Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain.~     It is found in many pain medicines that people take after having surgery. Narcotics are~     other drugs also used for pain (examples of narcotics are morphine and related pain~     medications). Medical science knows for a fact that acetaminophen works well when taken with~     narcotics for moderate to severe pain. Recently, acetaminophen has become available in an~     intravenous (IV) form called Ofirmev®. The IV form means that acetaminophen can be given~     into a vein. The benefits of getting medicine from an IV include:~        -  making the medicine work quickly~        -  less medicine having to pass through the liver to be changed into a form that your body~          can process The investigators know that acetaminophen is helpful for pain relief at the~          time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient~          surgery for pain control when patients go home. The patient's surgeon uses it to~          control pain after surgery at home in the form of Lortab or Percocet (Lortab and~          Percocet also have a narcotic medicine that mixes with acetaminophen). Also, currently~          at Surgicare, some anesthesiologists give intravenous acetaminophen while the patient~          is waiting to go to surgery. The investigators currently do not give any patient~          acetaminophen by mouth BEFORE surgery. However, since the addition of the IV form to~          the drug market, there has been interest to see if the oral form is just as good or~          better in reducing pain after surgery. This is why we are asking patients to join our~          study. The goal of this study is to find out if the oral form (by mouth) or the IV form~          (given into a vein) of acetaminophen controls pain after surgery better.~   "
102823|NCT01711216|"~     Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan~     and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for~     management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,~     dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,~     infertility due to luteal insufficiency, as well as part of hormone replacement therapy.~     There are limited data regarding dydrogesterone's role in achieving cycle regularization~     from post-marketing settings. There is need to assess the persistence of dydrogesterone~     therapy in a post-marketing setting after cessation of treatment and whether the~     persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this~     observational program, the goal is to observe the possible implications of such treatment in~     terms of treatment length and response pattern.~   "
102824|NCT01711203|"~     Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a~     multimodal strengthening program, for patients under the age of 21, who have spondylolysis~     and/or spondylolisthesis.~      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in~     children and adolescents presenting with low back pain.~      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with~     functional performance test measures, exercise logs, adherence scale for patient and parent~     perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry~     Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will~     be randomized into two groups: bracing and a general strengthening program vs. bracing and a~     Pilates/motor learning program combined with a general strengthening program.~      This study will begin with an initial examination and continue with treatment sessions~     2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing~     the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome~     measures.~   "
102825|NCT01711190|"~     The aim of this project:~        1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and~          intracameral administration of bevacizumab.~        2. Medium-term follow up (6 months) of the induced corneal astigmatism.~        3. Investigating correlations between postoperative astigmatism, particularly with the~          postoperative IOP.~   "
102826|NCT01711177|"~     Glaucoma is the second leading cause of blindness among seniors in Canada. It is often~     associated with an elevated intraocular pressure (IOP), but its exact mechanism is still~     largely unknown. Some studies have shown a link between glaucoma and changes in the amount~     of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular~     veins among three different groups using a spectrophotometer. This instrument is linked to a~     camera and can measure the quantity of oxygen in the veins using different characteristics~     of the blood inside.~      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and~     patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost~     0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.~     Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten~     patients will be recruited into each group for a total of 30 patients in this study. All~     patients for the suspected or diagnosed groups will be recruited from the Jewish General~     Hospital. Subsequently all testing will be done at the École d'optométrie, Université de~     Montréal~   "
102827|NCT01711164|"~     Viral hepatitis is a serious world health problem affecting over 1 billion people worldwide.~     Presently the lack of highly effective treatments results in many patients requiring liver~     transplantation or death. The investigators have defined the role of a unique molecule FGL2~     and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human~     hepatitis. The studies proposed in the present proposal will test the hypothesis that~     measuring levels of fgl2 in plasma will identify individuals that will go on to develop~     chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with~     both acute and chronic disease to develop an appropriate immune response and clear the~     virus. The studies will provide rationale for generation of new therapies to improve the~     treatment of patients with acute and chronic viral hepatitis by targeting fgl2.~   "
102828|NCT01711151|"~     1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how~          this varies between subgroups of ILD.~        2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered~          breathing within ILD patient population.~        3. To assess the economic impact of ILD.~        4. To understand how self-aware ILD patients are regarding their treatment/management.~        5. To compare the demographic details, including smoking status and occupational history,~          of patients with interstitial lung disease~   "
102829|NCT01711138|"~     The purpose of this study is to evaluate if changes to the built environment influence~     physical activity and active transport to school in children and youth.~   "
102833|NCT01711086|"~     Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers~     with stable asthma aged 8-18 years. Participants will perform lung function as part of the~     routine follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry~     powder inhaler) or with the Inspiromatic (an active, breath synchronized innovative~     inhaler). 3-60 days later participants will receive the same drug through the other inhaler.~      Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the~     blood, vital signs and side effects will be recorded.~   "
102834|NCT01711073|"~     A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in~     patients with chronic liver disease.~   "
102835|NCT01711060|"~     Increasing cesarean rate in France is worrying. Different methods are described for ripening~     labor : the use of prostaglandins is described but maybe dangerous for patients with scarred~     uterus and is not recommended.~      Intracervical balloon is an efficient alternative methods which as already been tested for~     unfavorable cervix ripening on nulliparous women.~      But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score~     <4).~      The investigators propose a prospective randomised trial comparing cervix ripening with~     intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin~     (reference method).~      The investigators expect to demonstrate what it's a safe method to increase vaginal delivery~     for women with previous cesarean section who need an induction of labour.~   "
102836|NCT01711047|"~     The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly~     defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation~     in addition to pulmonary vein isolation and linear ablations improves single procedural~     success rate over a 12 month follow up period.~   "
102837|NCT01711034|"~     The primary objective of this study is to determine the safe and tolerable dose level of~     OPB-111077 for patients with advanced cancer.~   "
102838|NCT01711021|"~     This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the~     treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.~   "
102839|NCT01711008|"~     Both regular exercise and breakfast consumption have well known health benefits. Consuming~     breakfast prior to morning exercise may influence appetite, mood and cognitive function~     later in the day. The purpose of this study is to test whether the amount of food consumed~     at breakfast prior to exercise influences these parameters in active women.~   "
102840|NCT01710995|"~     The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder~     and Losec 20mg capsules in healthy volunteers under fasting conditions.~   "
102841|NCT01710982|"~     A study to evaluate the safety of TZP-101 in comparison with placebo when administered~     post-operatively in patients who have undergone partial bowel resection.~   "
102842|NCT01710969|"~     The planned study will randomly assign aggressive children to one of two versions of the~     Coping Power child component. The two versions of Coping Power will either deliver the child~     component of the program in the usual small group format (Group Coping Power: GCP) or in a~     newly-developed individual format (Individual Coping Power: ICP). By providing a direct~     comparison of two different formats of the same intervention, the planned study's design~     will fill a critical gap in our current understanding of the relative effectiveness of group~     vs. individual programs. Further, this study will allow for examination of the specific~     factors that influence relative effectiveness of these two formats, important information~     with broad implications for program development, training of clinicians, and intervention~     implementation.~   "
102843|NCT01710943|"~     The proposed study involves developing and evaluating an interactive, web-based CBT~     intervention for OEF/OIF Veterans with hazardous or problematic substance use and PTSD~     symptoms (PTSD or subsyndromal PTSD). The intervention will address the special culture and~     experiences of the investigators targeted population (OEF/OIF Veterans). The web-based CBT~     intervention includes 24 modules, to be used across 24 sessions targeting OEF/OIF Veterans~     with hazardous or problematic substance use and PTSD symptoms. The investigators ask~     participants to complete 2 sessions per week (one module per session) for 12 weeks. The~     first 18 modules to be completed across 18 sessions (9 weeks) are considered core modules~     relevant to all Veterans in the target population. These modules are designed to reduce~     posttraumatic stress symptoms as well as reduce and prevent the escalation of problematic~     substance use. The remaining 6 module topics are considered optional and are used based on~     the interest and clinical need of various sub-groups of VA patients. The study includes~     initial input as well as feedback on a beta version from experts who have worked with~     OEF/OIF veterans with PTSD and substance abuse problems as well as input/feedback from the~     target population (the Veterans themselves). In addition to presenting content grounded in~     evidence-based CBT interventions, the program also employs state of the art technologies to~     deliver module content grounded in evidence-based learning principles, including~     Computer-Assisted Instruction, Computer Simulation and other interactive exercises.~   "
102844|NCT01710930|"~     The main objective of this study is to determine if a doubling of serum TARC (compared to~     baseline) is associated with the occurrence of exacerbations of ABPA.~      The secondary objectives of the study are :~        1. To investigate if induced sputum eosinophils count (compared to baseline) is associated~          with the occurrence of exacerbations.~        2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence~          of exacerbations.~        3. To investigate if activation of circulating T cells (compared to a baseline) is~          associated with the occurrence of exacerbations.~        4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline)~          is associated with the occurrence of exacerbations.~        5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE~          measured at baseline, may be associated with the radiological stage of the disease~          (ABPA-S, ABPA-CB, ABPA-ORF).~        6. To investigate if there is a link between fungal exposure at home (visually assessed by~          the contamination level and the proportion of positive samples for Asp. f) and the~          frequency of exacerbations.~        7. To establish if some of the clinical, functional or biological data studied are~          associated with the frequency of exacerbations.~   "
102845|NCT01710917|"~     This non-interventional, observational study evaluates the efficacy of Targinact with regard~     to quality of life in daily clinical practice in Belgium compared to the previous analgesic~     treatment.~   "
102851|NCT01710839|"~     To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease~     the total number of intravitreal injections in a year for ischemic central retinal vein~     occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to~     standard of care~   "
102852|NCT01710826|"~     To assess in healthy adult subjects:~        -  The tolerability and safety of ascending repeated oral doses of Genz-682452.~        -  The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.~        -  The pharmacodynamics of Genz-682452 after ascending repeated oral doses.~   "
102853|NCT01710813|"~     To collect uniform and meaningful data on patients with Pompe disease who experience~     anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic~     immune complex-mediated reactions following treatment with alglucosidase alfa.~   "
102854|NCT01710800|"~     The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on~     the total number of reflux episodes in the distal esophagus measured by impedance in~     patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH~     testing. In addition to changing the acidity of the refluxate, the investigators hypothesize~     that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.~   "
102855|NCT01710787|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and~     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.~   "
102856|NCT01710774|"~     This study will investigate whether telemedicine follow-up care for people with~     diabetes-related foot ulcers in municipal primary health care in collaboration with~     specialist health care is an equivalent alternative to traditional outpatient clinical~     follow-up in specialist health care (noninferiority trial) in relation to healing time.~   "
102857|NCT01710761|"~     Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance~   "
102858|NCT01710748|"~     This study is a prospective, randomized controlled, single blind, two-arm, multicenter~     clinical evaluation.~      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of~     the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)~     Polymer-Based Everolimus-Eluting Stent.~      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent~     implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based~     Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as~     the primary imaging modality.~   "
102859|NCT01710735|"~     In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will~     explore muscle contractility characteristics, the occurrence of post-intervention muscle~     soreness and the effect of dry needling on muscle contractile characteristics and clinical~     outcomes.~   "
102860|NCT01710722|"~     The purpose of this study is to compare three treatments to see which causes the most weight~     loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.~   "
102861|NCT01710709|"~     This will be an open-label uncontrolled trial to evaluate the safety and tolerability of~     aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar~     I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo~     subjects not participating in Trial 31-08-250.~   "
102862|NCT01710696|"~     This trial is conducted in Europe. The aim of the trial is to induce normal pubertal~     development in girls with Turner Syndrome in accordance with that of their peers and their~     individual state psychosocial maturation.~   "
102863|NCT01710683|"~     After lumbar discectomy 1st postoperative day high intensity exercise training reduced~     hospital stay, pain and sick leave without side effects in the two year follow-up period.~   "
102864|NCT01710670|"~     To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects~     of Ethanol~   "
102865|NCT01710657|"~     The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of~     orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and~     Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary~     generalization.~   "
102866|NCT01710644|"~     The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to~     Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine~     Pancreatic Insufficiency due to Cystic Fibrosis~   "
102867|NCT01710631|"~     A six-month study to determine the safety and efficacy with an additional open-label~     extension to determine the long-term safety of eszopiclone in the treatment of adult~     subjects with primary insomnia.~   "
102868|NCT01710618|"~     The purpose of the study is to elucidate the different proteins that may appear on the~     injured end of the sciatic nerve and compare it to the other end of the cut nerve, which~     is uninjured. By comparing the normal versus traumatized ends of the cut sciatic~     nerve, the investigators hope to identify proteins that may be specifically related to pain.~     For instance, if the non-traumatized end of the nerve has none of Protein X but the~     traumatized end of the nerve has a lot of Protein X, then Protein X would be a protein that~     the investigators will want to study further and see if it plays any role in the sensation~     of pain.~      Other studies have shown that there are specific pain-related proteins and they may be~     increased or decreased after traumatic injury. If the investigators are able to identify~     specific proteins that are related to pain, then that may eventually lead to the development~     of medications that will block those proteins and decrease the sensation of pain.~   "
102869|NCT01710605|"~     The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking~     into account circulating tumor cells (CTC) to determine the kind of first line treatment for~     metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of~     treatment will be decided by clinicians, taking into account the criteria usually used in~     this setting. In the CTC arm, the type of treatment will be decided by CTC count:~     hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main~     medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the~     progression-free survival: 994 patients are needed, and will be accrued in French cancer~     centers. Secondary clinical objectives are to compare toxicity, quality of life and overall~     survival between the two arms. The medico-economic study will compare cost per~     progression-free life years gained of the two strategies. The financial impact of~     centralized (one platform) vs decentralized (several platforms) CTC testing will be~     evaluated.~   "
102870|NCT01710592|"~     Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced~     gastro-oesophageal cancer, their role, however, in the management of this disease remains~     unclear. Furthermore it is unclear whether this disease is optimally treated with a~     combination of two or three cytotoxic drugs. This trial aims to determine whether the~     combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal~     phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the~     comparator arm for this evaluation.~      Primary Objective:~      Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is~     comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation~     in advanced gastro-oesophageal cancer.~      Secondary Objective:~      To examine the effect of treatment on time to progression, progression free survival,~     overall survival, quality of life, and the associated toxicity from treatment.~   "
102871|NCT01710579|"~     Ano-rectal manometry is indicative in patients with either fecal incontinence or~     constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure~     variations are measured circumferentially along the anal canal. It may allow a better~     understanding of anorectal disorders by displaying anal pressure asymmetry and it could be~     useful to assess the functional anatomy of the pelvic floor better than conventional~     manometry.~   "
102872|NCT01710566|"~     This community-based cluster Randomised Control Trial will assess the feasibility, cost,~     risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as~     prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be~     conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program~     to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective~     in preventing PPH when introduced in community-based settings.~   "
102873|NCT01710553|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to~     demonstrate the bioequivalence of Metformin 1000 mg tablets manufactured by Savipharm J.S.C,~     Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male~     subjects under fasting condition~   "
102874|NCT01710540|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to~     demonstrate the bioequivalence of Metformin 850 mg tablets manufactured by Savipharm J.S.C,~     Vietnam and Glucophage® 850 mg tablets of Merck Sante, France, in healthy adult human male~     subjects under fasting condition.~   "
102875|NCT01710527|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study.~      To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm~     J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male~     subjects under fasting condition and to monitor the safety of the study subjects.~   "
102876|NCT01710514|"~     The purposes of the study are to verify sufficient supplementation of luteal hormone after~     administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to~     determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing~     fertility treatment with IVF-ET (a fresh embryo transfer).~   "
102877|NCT01710501|"~     This is a study designed to compare the safety and efficacy of 3 different doses of~     grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin~     (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC).~     Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and~     RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of~     treatment with Peg-IFN and RBV.~   "
102878|NCT01710488|"~     The primary objective of the study is to determine the percentage of patients with~     therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two~     treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be~     evaluated on the basis of a score determined in relation to the signs-symptoms of acute~     exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)~   "
102879|NCT01710462|"~     This superiority phase III study to compare the combination of Pantoprazole and Domperidone~     with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The~     hypothesis is that combination of the two medication at the unique capsule is better to the~     patients because decrease the quantity of times the patients need to take medicines during~     the day.~   "
102880|NCT01710449|"~     An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal~     controls. Each subject will receive PFP as a contrast agent to visualize the airway and~     alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen~     mixtures.~   "
102881|NCT01710436|"~     This study is a prospective, observational study to estimate the relationship between dosage~     of clopidogrel and platelet aggregation in Chinese with different genotype. The~     investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary~     intervention (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as~     clinical outcome.~   "
102882|NCT01710423|"~     This study aims to test the effectiveness of a community-located, peer mentored intervention~     to improve home food preparation practices in families with young children.~   "
102883|NCT01710410|"~     The purpose of this study is to determine the effectiveness of transcranial direct current~     stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine~     dependent smokers.~   "
102911|NCT01710033|"~     This was a Phase 1 dose escalation study to evaluate the safety, tolerability and~     pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In~     Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts~     of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded~     cohort in Stage 2.~   "
102912|NCT01710020|"~     There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered~     approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the~     drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a~     second period (Period 2) will be conducted. In Period 2, a single dose of drug will be~     administered approximately 4 hours prior to hemodialysis.~   "
102884|NCT01710397|"~     One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS~     in resource-constrained settings is the failure of ART-eligible patients to complete the~     steps required to initiate treatment. The high rate of loss to care of patients who are~     treatment-eligible at HIV diagnosis may be due in part to the large number of steps required~     between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs).~     In South Africa, these steps usually require approximately four clinic visits over a period~     of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses~     among those eligible for ART is to simplify and condense the steps required for starting~     treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and~     tuberculosis (TB) diagnosis are available. These technologies can be combined with changes~     to clinic schedules to allow all steps required for ART initiation under South African~     guidelines (lab tests, physical exam, education) to take place on the day the patient~     presents for an HIV test.~      This study is a randomized strategy evaluation of the feasibility, effectiveness, and~     cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults~     who come to a South African clinic for an HIV test, consent to study participation, and are~     eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those~     who are assigned to rapid ART initiation will have the possibility of receiving their first~     dose of ARVs as early as the same day, while those who are assigned to standard care will~     follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive~     pregnant women, which has recently become the standard of care in South Africa, will also be~     assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a~     retrospective comparison group. The primary study outcome for non-pregnant adults will be~     remaining alive, in care and virally suppressed 10 months after having a positive HIV test~     at the study site or making a first HIV-related visit. The primary study outcome for~     pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid~     initiation strategy will be assessed as the cost per patient achieving the primary outcome~     for each population.~   "
102885|NCT01710384|"~     To test the effect on premature infants of a one-time course of betamethasone administered~     in weeks 34-36 of gestation.~   "
102886|NCT01710371|"~     To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late~     type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control~     subjects. These subjects will also be evaluated for beta-cell function as measured by the~     insulin and C-peptide response to a challenge with intravenous arginine under basal and~     glucose enhanced conditions.~   "
102887|NCT01710358|"~     The purpose of this study is to determine whether baricitinib is superior to placebo in the~     treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who~     have had an inadequate response to methotrexate (MTX) treatment.~   "
102888|NCT01710345|"~     This is a dose-finding study to determine if the sublingual administration of the Sufentanil~     NanoTab is safe and effective in the treatment of post-operative pain.~   "
102889|NCT01710332|"~     A preliminary study to determine the safety and efficacy of intravitreal aflibercept~     injection in patients with persistent central serous chorioretinopathy.~   "
102890|NCT01710319|"~     The purpose of this research study is to investigate the differences in natural killer (NK)~     blood cells, a type of white blood cell that fights infection in the body, among different~     types of patients that have lung surgery. The four different groups of patients are:~        -  smokers with lung cancer~        -  smokers without lung cancer~        -  non-smokers with lung cancer~        -  non-smokers without lung cancer.~   "
102891|NCT01710306|"~     Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA~     users. While PTSD is prevalent in this group, most women don't access or complete needed~     treatment. This study will investigate OEF/OIF/OND RNG female war Veterans' perceptions,~     preferences, barriers and facilitators to accessing VA mental health (MH) and evidence-based~     PTSD psychotherapy. This information will be used to revise an existing web-based screen~     that educates participants about their unique post-deployment MH conditions. This~     web-interface will then be used to randomly assign women who screen positive for PTSD to~     either 1) a concierge nurse case manager who uses shared decision-making to engage Veterans~     in EBP or 2) usual outreach to determine what engagement approach women prefer. The~     investigators' findings will provide VA leaders with key information to understand and~     improve access to RNG PTSD treatment.~   "
102892|NCT01710293|"~     Many missed and delayed cancer diagnoses result from breakdowns in communication and~     coordination of abnormal findings suspicious for cancer, which often first emerge in the~     primary care setting. Delays in the follow-up of abnormal test results persist despite the~     reliable delivery of test results through the electronic health record.~      This intervention is the final study in a three-phase project that will develop and test an~     innovative automated surveillance intervention to improve timely diagnosis and follow-up of~     five common cancers in primary care practice.~      The investigators hypothesize that the median time in days from diagnostic clue to follow-up~     action (e.g. time to colonoscopy examination after am abnormal colon-related test) will be~     significantly less in the intervention arm than in usual care. The investigators also~     hypothesize that the proportion of patients receiving appropriate and timely follow-up care~     will be significantly higher in the intervention arm than in usual care.~   "
102893|NCT01710280|"~     The purpose of this study is to determine whether high-fat meals rich in palmitic acid in~     the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting~     triacylglycerol concentrations.~   "
102894|NCT01710267|"~     Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied~     for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA~     is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and~     for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.~      This is an explorative laboratory study to evaluate the intra-individual variability of RXA~     conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.~   "
102895|NCT01710254|"~     Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a~     need for research to elucidate the prevalence of ischemic cardiomyopathy in patients~     diagnosed with AF. The objective of this study is to demonstrate the utility of MRI in~     assessment of coronary artery disease. The specific objective is to demonstrate~     sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and~     adenosine (90% /80%) in an AF population using the time-efficient vasodilator regadenoson~     that requires only a single intravenous (IV).~   "
102913|NCT01710007|"~     1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its~     active compound, pitavastatin has recently been approved by US FDA for indications of~     primary hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic~     properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does~     not depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and~     safety of 1PC002 administered for 12 weeks is non-inferior to atorvastatin.~   "
116637|NCT01529346|"~     The objective of this study is to evaluate the overall pain relief of a single dose of~     PF-05089771 against placebo following third molar extraction.~   "
102896|NCT01710228|"~     This study is being done to determine the difference between natalizumab therapy followed by~     two different withdrawal strategies using Glatiramer Acetate (GA) treatment paradigms in~     preventing clinical relapses and other markers of disease activity in patients diagnosed~     with Multiple Sclerosis (MS).~      We hypothesize that GA plus corticosteroids versus GA alone will prevent or reduce the~     re-occurrence of MS disease activity after discontinuation of natalizumab over a 12 month~     period. We further hypothesize that natalizumab therapy followed by GA treatment allows the~     reconstitution of the peripheral and CNS immune homeostasis.~      Primary objective:~      The primary endpoint will be the annualized relapse rate over the post randomization months~     as well as estimates of change over the natalizumab therapy period over the entire 12~     months.~      Secondary objectives:~      To determine if and how long it takes for restoration of immune homeostasis under GA therapy~     following discontinuation of natalizumab.~   "
102897|NCT01710215|"~     Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death~     can be reduced by screening. However, there is uncertainty as to which screening strategy is~     most clinically and cost-effective from a population perspective where the aim is to~     optimize completion of the entire screening process continuum. Modeling studies suggest~     benefits and harms of colonoscopy and stool blood test strategies are similar, but generally~     assume 100% participation and subsequent clinically appropriate follow up--something never~     achieved in clinical practice. Comparative effectiveness studies of testing strategies,~     including comparisons of specific tests and approaches to optimizing effective test use, are~     necessary. Safety-net health systems care for populations at increased risk for adverse CRC~     outcomes, such as the uninsured and minorities, and have more limited resources. Therefore,~     safety-nets must resolve the uncertainty regarding the most effective screening strategy.~     The investigators will conduct a system-level, randomized comparative effectiveness trial of~     the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients~     age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net~     health system. The three strategies studied will be: 1) Fecal immunochemical testing, with~     annual mailed invitation outreach (including a test kit), and a centralized process to~     promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual~     mailed invitation outreach, and a centralized process to promote participation and complete~     clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening~     offered at primary care visits. The primary measure of benefit will be an outcome measure~     that summarizes patient-specific effective screening successes. The primary measure of harm~     will be screening non-participation. The primary measure of cost will be cost per-patient~     effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a~     FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with~     screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care~     and b) the Colo strategy vs. Usual Care for CRC screening.~   "
102898|NCT01710202|"~     The current study will test the causal relationship between elevated levels of cortisol and~     the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to~     environmental threat. The investigators predict that carriers of the short allele of the~     serotonin transporter gene who have elevated cortisol levels will be most sensitive to~     threatening environments, whereas carriers of the long allele who do not have elevated~     cortisol (placebo subjects) will be least sensitive.~   "
102899|NCT01710189|"~     Many viral infections of global importance, including HIV, are transmitted across the~     mucosal surface of the genital tract. As immunity against these infections is likely to be~     primarily mediated by antibodies in mucosal secretions, developing techniques to increase~     the levels and persistence of antiviral antibody on mucosal surfaces may enhance the~     protection against a number of important infections. Preclinical studies have anatomically~     targeted vaccine antigens to sites where genital tract immunity is induced. This response is~     likely due to the ability of regional lymph Preclinical studies have anatomically targeted~     vaccine antigens to sites where genital tract immunity is induced. This response is likely~     due to the ability of regional lymph nodes to pattern the cell surface markers of~     responding vaccine specific lymphocytes with homing markers. In contrast, injecting a~     distant muscle (such as in the arm) which shares no anatomical relationship with the vagina,~     may not pattern cells with homing markers for the genital tract. Direct injection of~     inguinal lymph nodes is impractical in humans but intramuscular injection into the thigh~     will target antigens to the deep inguinal lymph nodes shared in common with the~     cervix/vagina.~      This study will be a Phase IV randomised, single centre, open label, laboratory assessment~     blinded exploratory trial to assess mucosal immunogenicity following three targeted~     intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2~     groups immunised in right deltoid or right anterolateral thigh.~      Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There~     will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood~     samples and cervicovaginal secretions will be taken prior to each immunisation for~     immunological measures. In addition, blood samples will be taken at each immunisation and~     follow up visit for measurement of peripheral blood mononuclear cells.~      The study is funded by ADITEC, which is a collaborative research programme that aims to~     accelerate the development of novel and powerful immunisation technologies for the next~     generation of human vaccines.~   "
102900|NCT01710176|"~     This is a randomized Phase III clinical trial in the setting of localized high-risk soft~     tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with~     epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy~     tailored to the specific histology within the family of adult STS. Chemotherapy will be~     administered for 3 cycles. There will be five histological groups (representing 80% of STS),~     as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS),~     synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated~     pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be,~     respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide~     plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included~     and registered, but treated only by standard chemotherapy. Patients who have already~     undergone definitive surgery will receive treatment post-operatively and patients needing a~     re-excision after inadequate surgery will be treated as patients in the two groups, but of~     course will not be evaluable for response. A centralized pathological review will be~     performed. Radiological response will be evaluated according to RECIST and to Choi criteria.~     Pathological response will also be recorded.~      The endpoint will be disease-free survival (DFS) and, secondarily, overall survival (OS) of~     patients receiving standard chemotherapy versus those receiving histotype-tailored~     chemotherapy. Additional aims will be to compare the probability of response of standard vs~     histotype-tailored chemotherapy and to determine the radiological and pathological response~     with standard chemotherapy vs tailored chemotherapy in each different histological group.~     Another aim will be to validate the response (both radiological and pathological) to~     preoperative chemotherapy as a surrogate endpoint for DFS and OS.~      Three hundred patients will be randomized over a 3-years period, from a pool of 400-450~     registered patients.~      Translational research will be performed. Areas of research will include identification and~     validation of the potential predictive markers for each histological subgroups.~      The study is designed to verify the statistical hypothesis that histotype-tailored approach~     is associated, overall, with a 30% reduction in the hazard of relapse. However, in each~     different histological group, the effect of histotype-tailored chemotherapy, as compared to~     standard chemotherapy, can be different. To address this weakness an orthogonal study of~     response to chemotherapy as a surrogate of DFS and OS has been introduced into the trial.~     This study intends to extensively investigate the response (radiological and pathological)~     to preoperative chemotherapy and to validate it as a surrogate endpoint by showing that it~     correlates with disease free survival and overall survival.~   "
102901|NCT01710163|"~     The purpose of this study is to determine whether Bipolar I Disorder refractory treatment~     with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The~     investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and~     tolerability in maintenance treatment.~   "
102902|NCT01710150|"~     The purpose is to compare long term occurrence of atrial arrhythmias including atrial~     fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in~     patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation~     alone versus CTI ablation combined with pulmonary vein isolation (PVI).~   "
102914|NCT01709994|"~     The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg /~     day) reduces the risk of cardiovascular disease in patients with chronic kidney disease~     (stage 3 or 4).~   "
102926|NCT01709838|"~     To assess the efficacy of deferasirox in patients with non-transfusion dependent thalassemia~     based on change in liver iron concentration from baseline after 52 weeks of treatment. To~     provide further assessment of the long-term efficacy and safety of deferasirox in NTDT~     patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260~     weeks.~   "
102903|NCT01710137|"~     Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral~     therapy (HAART) has greatly improved survival rates and changed the leading causes of death,~     from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use~     among individuals with HIV/AIDS are very high and varenicline may be particularly~     efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this~     trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking~     cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The~     investigators hypothesize that 1) varenicline and counseling will significantly increase~     end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo~     and counseling; 2) quality of life will be rated higher in the varenicline and counseling~     group versus the placebo and counseling group, and there will be no significant differences~     between treatment arms in terms of the frequency of severe varenicline-related side effects;~     and 3) improved affect and reduced cognitive impairment will mediate the effect of~     varenicline therapy on quit rates.~   "
102904|NCT01710124|"~     The prevalence of overweight and obesity among older adults has reached an all-time high,~     which puts this age group at high risk for associated comorbidities such as type 2 diabetes,~     cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and~     economic uncertainty, many middle-aged and older Americans tried to save on their food~     purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,~     mail, and increasingly online, are one of several promotional tools that supermarkets and~     warehouse clubs use to promote sales. It is estimated that nationally 27% of households are~     frequent grocery coupon users who shop at a variety of retailers. Despite the increasing~     popularity of grocery coupons, little is known about the extent to which they may promote~     obesogenic home food environments and eating behaviors. Many coupons advertise the purchase~     of large quantities of prepackaged and processed foods and often reward shoppers by adding~     'free' products if they purchase certain quantities. Availability and easy accessibility of~     large portions of energy dense foods in the home has been shown to promote increased intake.~     The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary~     intake, weight status, and home food availability among middle-aged and older adults. A~     second aim of this study is to test, in a randomized-controlled trial, the effects of~     incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in~     dietary intake, body mass index/waist circumference, home food availability, and grocery~     coupon use among frequent coupon users and non-coupon users.~   "
102905|NCT01710111|"~     The ways in which influenza is transmitted between people are uncertain; for example, we do~     not know if large droplets or fine particles (aerosols) matter most; both are produced by~     coughing and sneezing. This means we cannot say what precautions work best in real life.~     Improving our understanding is vital to allow the development of guidelines and policies to~     help reduce the transmission of both pandemic and seasonal flu.~      The aim of this study is to explore how influenza is spread, specifically by looking at the~     importance of spread via small particles (aerosols/droplet nuclei) that are carried in~     respiratory sprays e.g. produced by coughing and sneezing.~      The primary objective of this study is:~      To estimate the contribution of aerosols/droplet nuclei to influenza transmission by~     determining the secondary attack rate (SAR) of influenza in Recipients randomised to a~     control arm (no intervention - allowing all modes of transmission) compared to Recipients~     randomised to an intervention arm (face shield and hand hygiene - allowing only transmission~     by aerosols/droplet nuclei) when both groups of Recipients are exposed to Donor volunteers~     infected with influenza via intranasal drops.~      The hypothesis is that:~      The SAR will be lower in Recipients exposed only to aerosols/droplet nuclei (intervention~     arm) compared to those exposed to all modes of transmission (the control arm):~     aerosols/droplet nuclei, droplet spray (larger respiratory droplets) and transmission~     through contact.~   "
102906|NCT01710098|"~     How are testosterone levels of patients with prostate cancer under treatment with Firmagon®~     changing.~      Former studies showed a quick fall of testosterone levels after start of therapy with~     Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this~     in a normal outpatient urologist setting. Furthermore data is collected to prove the~     adherence to the German S3-Guideline for the treatment of prostate cancer.~   "
102907|NCT01710085|"~     Endometrial and cervical cancers are one of the most common malignancies seen in females.~     Identification of recurrent disease in early phases of treatment carries a primary~     importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI)~     is a new technique recently started to be performed in body imaging and has potential~     ability to detect recurrent disease. The aim of this study is to investigate the diagnostic~     impact of DWI in detection of recurrent disease in patients treated with curative surgery in~     endometrial and cervical cancer.~   "
102908|NCT01710072|"~     Hypothesis: aspirin attenuates inflammation in cerebral aneurysms and hence reduces the~     incidence of rupture. This effect can be monitored using the signal generated by macrophages~     (inflammatory biomarker) in ferumoxytol-enhanced MRI.~      Study aims:~      1. Determine if daily aspirin intake (for three months) would obliterate/reduce~     ferumoxytol-enhanced MRI signal changes generated by macrophages in cerebral aneurysm wall.~     Fifteen patients with cerebral aneurysms > 7 mm will be selected to enroll in this pilot~     study. 10 patients will be imaged at base line with ferumoxytol-enhanced MRI. Following~     that, they will take aspirin 81 mg daily and then re-imaged again at three months. This~     group will be compared to a control group of 5 patients where they will have the imagings~     studies performed at base line and at three months but will NOT take aspirin.~   "
102909|NCT01710059|"~     This study has two main goals. The first goal is to test whether a mobile phone intervention~     can increase adherence to daily inhaled steroid medications in African American adolescents~     prescribed this type of medication by his/her asthma doctor. The second goal is to use a~     mobile phone intervention to better understand real life patterns of use of quick-relief~     (beta2-adrenergic agonist) asthma medication in this population.~   "
102910|NCT01710046|"~     There are cells in the skin and blood of humans with chronic moderate to severe plaque~     psoriasis with specific activities that may determine the effectiveness of treatment. These~     activities may be described by obtaining samples of skin and blood and analyzing them using~     a variety of tests.~   "
116638|NCT01529333|"~     The purpose and objective of this study is to evaluate the safety and efficacy of the MET V~     System for the treatment of individuals with mixed hearing loss.~   "
102915|NCT01709981|"~     Peri-procedural inflammation is associated with increased rates of post-procedural~     myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves~     associated with increased risk of later MI and death. Statins suppress both inflammatory~     markers and MI rates during and after PCI, but ≥ 40% of PCI patients go statin-untreated,~     due in part to side effects such as myalgia. Moreover, because their mechanism of action~     relies on post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a~     time frame that is not always feasible. The investigators propose a novel alternative~     approach to reduce inflammation during PCI employing colchicine, an anti-inflammatory~     medication used frequently in gout and pericarditis. Colchicine may be particularly~     applicable to the PCI setting due to its rapid onset of action and excellent side-effect~     profile at low doses, as well as its known mechanisms of action. However, data on colchicine~     use in patients with coronary disease is extremely limited, and no studies to date have~     evaluated the use of colchicine in patients undergoing PCI. The investigators aim to~     characterize a potential mechanism of benefit in patients undergoing PCI by evaluating the~     effects of colchicine on soluble and leukocyte surface markers after PCI. The investigators~     also aim to determine the effects of colchicine on peri-procedural myonecrosis and MI.~     Accordingly, the investigators propose a prospective randomized study to characterize the~     effect of colchicine on inflammation and peri-procedural myocnecrosis. Patients referred for~     possible PCI will be randomized in a double-blinded fashion to placebo or colchicine (1.2mg~     1 to 2 hours before PCI, followed by 0.6mg 1 hour later). The primary endpoint will be~     post-procedural interleukin-6 level. Secondary endpoints will include other relevant soluble~     and leukocyte-associated inflammatory markers and rates of peri-procedural myonecrosis and~     MI. Sample size needed is 200 patients undergoing PCI. 400 patients will likely be needed to~     be enrolled to reach 200 PCIs given that no more than 50% of patients enrolled may undergo~     diagnostic only procedure (without PCI).~   "
102916|NCT01709968|"~     Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at~     rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential~     benefits in trials of magnesium. This is a single center, prospective, randomized, double~     blind, placebo controlled clinical trial that aims to investigate the effect of treatment~     with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &~     Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and~     severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce~     the number and severity of NLC; an improvement in the quality of life and quality of sleep~     may ensue.~   "
102917|NCT01709955|"~     The purpose of this study is to determine if the herb, Glucomannan, is an effective~     non-pharmacological appetite suppressant for overweight or Class I obese patients. The study~     design will not include any other lifestyle changes which enhance weight loss in order to~     completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.~   "
102918|NCT01709942|"~     In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in~     a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian~     hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.~   "
102919|NCT01709929|"~     This trial is conducted in North America. The aim of this trial is to evaluate the safety of~     insulin detemir for the treatment of diabetes.~   "
102920|NCT01709916|"~     Glaucoma is one of the leading causes of blindness in the west. The disease caused by high~     intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss~     of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of~     the therapy it is common to measure the intra ocular pressure at different times of the day.~     Most ophthalmologists admit the patient for one day at which intra ocular pressure is~     measured at different times. This method does not mimic the patient daily routine and may~     not reflect the true diurnal fluctuations.~      For this reason some ophthalmologists measure the intra ocular pressure at different times~     and at different days. It is not known if both methods give similar diurnal curves.~   "
102921|NCT01709903|"~     To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50~     µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours~     15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients~     with moderate to severe COPD~   "
102922|NCT01709890|"~     Patients under sedation not uncommonly develop upper airway obstruction or other respiratory~     complications and no airway device is available to provide reliable maintenance of the~     airway at present. I believe the YO2(R)airway catheter can improve the maintenance of patent~     airway in most sedated patients and improve O2 delivery to the airway. In addition it may~     also greatly facilitate the monitoring of expired CO2, which is widely recognised as the~     most important monitor of adequacy of breathing, yet frequently impossible to perform~     satisfactorily in sedated patients at the moment.~   "
102923|NCT01709877|"~     Its main objective is to evaluate the clinical outcome (including patient reported outcomes)~     and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic~     Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled~     prospective clinical trial (RCT) on specific operations performed (on a random allocation~     basis) by either the traditional multi-port laparoscopic approach or the Single Port-~     ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion~     criteria will be randomised over a three year period to have the operation by either of the~     two approaches.~   "
102924|NCT01709864|"~     The study serves to determine whether the treatment of patients with stable, symptomatic~     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is~     efficient and safe. The efficacy and safety of the drug will be tested against a placebo~     treatment.~      The primary criterion to assess efficacy will be the difference between the serial lung~     function measurements of patients who have been treated for 12 weeks with NVA237 versus~     those that have received placebo treatment for 12 weeks. A serial lung function measurement~     (FEV1 testing) will be conducted and the area under the curve will be the measure for the~     ability to breathe.~   "
102925|NCT01709851|"~     Over the last years, a number of systems for continuous subcutaneous glucose monitoring have~     been marketed and are routinely used in patients with diabetes to obtain more detailed~     information about 24-hour glucose profiles.~      In the hospital, numerous factors influencing glycemic control and possibly leading to~     glucose excursions out of the desired range exist, e.g. interventions for which the patient~     has to remain fasting or medications such as corticosteroids or vasopressors. A reliable~     continuous glucose signal could help to observe levels of glycaemia not only at defined~     time-points but continuously, making it possible for physicians and nursing staff to better~     adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-~     or hyperglycaemia.~      In the hospital setting, vascular access is granted in the majority of patients and could as~     well be used as an alternative site for continuous glucose monitoring.~      The aim of the present study is to assess accuracy of the glucose data obtained by means of~     an intravascular microdialysis-based CGM system against venous blood glucose reference~     measurements.~   "
102928|NCT01709812|"~     A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label~     study in RRMS patients to assess the impact of an individualized patient support program~     (PSP) on treatment satisfaction and to evaluate whether this individualized support improves~     satisfaction and with it adherence to medication compared to standard care.~   "
102929|NCT01709799|"~     The purpose of this research study is to help scientists and health care providers learn~     more about preventing dementia and brain disease in older adults. There is an urgent need to~     develop strategies to prevent or slow down memory loss and brain function decline in the~     elderly.~      In this study, the investigators hope to learn how physical exercise and a brain training~     program work together to improve thinking and memory in older adults. Specifically, these~     aims include:~        -  Learning whether physical activities (like biking or treadmill walking or Wii Fit~          games) will help improve the benefits of a brain training program. Based on preliminary~          results and that in the literature, the investigators anticipate greater cognitive~          benefits in the Exercise + Cognitive training groups than the Cognitive Training alone~          group.~        -  To determine whether the benefits of adding exercise will occur quickly or develop more~          gradually over time. The investigators suspect that a major benefit of exercise~          pre-dosing will occur by the 12th week of the program.~        -  To examine whether Wii-Fit exercise games cause similar effects on brain training as~          traditional exercise programs such as biking or walking. Although several recent~          studies have raised questions about the true aerobic benefit of exergames such as~          Wii-Fit Plus, other evidence suggests that these weaker aerobic benefits may be offset~          by the greater novelty and interest level afforded by exergames.~   "
102930|NCT01709786|"~     This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in~     patients with suspected hemorrhage. These methods will be compared with standard laboratory~     measurements.~   "
102931|NCT01709773|"~     This is a pilot cohort study of women undergoing focal ablation for high-grade cervical~     intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.~     The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting~     inclusion criteria were recruited for enrollment into the pilot study of focal treatment.~     Upon enrollment, they underwent focal ablational treatment rather than standard ablational~     treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess~     safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be~     calculated.~   "
102932|NCT01709760|"~     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,~     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with~     Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis~   "
102933|NCT01709747|"~     The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride~     administered by intrathecal delivery.~   "
102934|NCT01709734|"~     A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration~     resistant prostate cancer (CRPC) patients.~   "
102935|NCT01709721|"~     The purpose of this study is to determine the safety and efficacy of hydromorphone~     hydrochloride by intrathecal administration using a programmable implantable pump.~   "
102936|NCT01709708|"~     Migraine imposes a substantial burden on patients in terms of diminished daily functioning,~     quality of life, and financial loss. Pain severity and duration correlates with reduced~     measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG)~     has been implicated in a variety of cephalalgias. This has been well represented in the~     literature dating back over a century. Access to this structure can be gained via a small~     area of mucosa just posterior and superior to the tail of the middle turbinate on the~     lateral nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG~     using local anesthetics relieves pain. Unfortunately, many current interventions are~     cumbersome, invasive, and expensive. The purpose of this study is to evaluate the efficacy~     of the Tx360™, a new nasal applicator device, in the treatment of head and face pain and to~     examine the economic implications. The Tx360™ is a single use device designed to deliver a~     topical local anesthetic to the specific area of mucosa associated with the SPG. A total of~     42 study participants will be accepted into this double-blind placebo-controlled study. 28~     will receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the~     Tx360™ while 14 will receive a placebo of saline substituted for the Marcaine. Both patient~     sets will also be given a piece of lemon hard candy as a taste distractor. Participants must~     have a chronic migraine history with over 15 symptomatic days per month over the past three~     months. The treatment plan consists of six weeks of treatment, two times per week. Short and~     longer term assessments will be retrieved and analyzed as detailed in the Study Design.~   "
102937|NCT01709695|"~     This study proposes to evaluate the effects of guanfacine extended release on brain~     activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD~     subjects randomized to placebo treatment.~      This study also proposes to collect DNA on study participants, to examine the genetic~     underpinning of the observed fMRI activation profiles at baseline and in response to~     treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other~     related targets) for genetic biomarkers in association with the fMRI findings of this study.~   "
102938|NCT01709682|"~     The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy~     (control) in patients with previous failed PVI ablation for paroxysmal AF.~   "
102939|NCT01709669|"~     Overall, the investigators aim to recruit 150 subjects during their hospitalization for an~     acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels~     of gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline~     information about health behaviors critical to cardiac health, and obtain baseline measures~     of symptoms and function. Finally, the investigators will repeat assessments of biomarkers,~     behavior, and function at 6 months to allow us to assess the impact of gratitude and~     optimism on these outcomes; the investigators will also have an objective measure of~     physical activity via accelerometer (step counter) at 6 months.~      Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks~     after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     reductions in levels of biomarkers associated with negative heart health between 2 weeks and~     6 months.~      Specific Aim #2 (*primary aim*): To assess the association between gratitude/optimism 2~     weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS~     prognosis at 6 months.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome~     measure), and greater improvements in self-reported adherence to health behaviors (activity,~     diet, and medication) between 2 weeks and 6 months.~      Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and~     non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     improvements in depression, health-related quality of life, function, cardiac symptoms, and~     possibly readmissions, between 2 weeks and 6 months.~   "
116639|NCT01529320|"~     Determine the mean time to itch relief from the start of treatment with topic~     methylprednisolone aceponate.~   "
102940|NCT01709656|"~     The investigators will recruit active ankylosing spondylitis patients for injection~     treatment of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine~     controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)~     and sera before and after the treatment of 24 weeks to test the gene expression profiles and~     study related pathogenesis of AS~   "
102941|NCT01709643|"~     The major research objective is to assess the potential of Proton Magnetic Resonance~     Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single~     meal. Furthermore we aim to investigate whether the addition of protein to a high fat~     breakfast results in a reduced postprandial accumulation of lipids when compared to a high~     fat breakfast alone.~   "
102942|NCT01709630|"~     Determine significant correlations between maternal serum magnesium levels, and maternal and~     neonatal outcomes.~   "
102943|NCT01709617|"~     Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO)~     during exercise delays the onset of fatigue and improves exercise performance by maintaining~     high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the~     preferential CHO source found in sports drinks. However, during the intestinal absorption of~     large amounts of glucose (>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may~     become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an~     effort to evade this limitation, research has suggested using multiple transportable~     carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are~     combinations of simple sugars that use different intestinal transporters during the~     absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity~     for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO~     oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to~     provide exogenous fuel during and following prolonged exercise.~   "
102944|NCT01709604|"~     Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with~     respiratory failure. Accumulating evidence suggested that continuous venovenous~     hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction.~     The investigators hypothesized that CVVH might restore multiple organ function and reduce~     the high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study~     would be carried out.~   "
102945|NCT01709591|"~     The purpose of the study is to determine if targeted prenatal educational program on womens'~     perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative~     to the control group.~   "
102946|NCT01709578|"~     Primary Objective:~      To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is~     effective for:~        -  reduction of signs and symptoms at Week 24 and~        -  improvement of physical function at Week 12~      in patients with active rheumatoid arthritis (RA) who are inadequate responders or~     intolerant to tumor necrosis factor alpha (TNF-α) antagonists.~      Secondary Objectives:~      The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to~     DMARD therapy, in patients with active RA who are inadequate responders or intolerant to~     TNF-α antagonists, for:~        -  Reduction of signs and symptoms at 12 weeks.~        -  Improvement in physical function at Week 24.~        -  Improvement in disease activity score as measured by other American College of~          Rheumatology derived components at Weeks 12 and 24.~        -  Improvement in quality of life as measured by patient reported outcomes (PROs) at~          intermediate visits and Week 24.~      To assess the safety of sarilumab in this population.~      To assess the exposure of sarilumab added to DMARD therapy in this population.~   "
102947|NCT01709565|"~     The purpose of this study is to compare lactate clearance in patients with severe sepsis and~     septic shock according to the presence of hepatic dysfunction.~   "
102948|NCT01709552|"~     The purpose of this study is to target co-occurring problems of substance use and intimate~     partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for~     Substance use and partner Abuse for Females in the Emergency Room). This project will~     develop and test the computer-based intervention, examining primary outcomes of substance~     use and utilization of relationship safety resources.~   "
102949|NCT01709539|"~     The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum,~     DC) in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious~     illness but who have no organ-specific symptoms will be referred to the DC for further~     investigation after preliminary assessment in primary care. The overall purpose of the study~     is to evaluate whether the DC meets its target time for diagnosing cancer. In addition, we~     will evaluate secondary issues, such as survival, to determine whether this pilot project~     merits extension to other parts of southern Sweden.~   "
102950|NCT01709526|"~     The aims of this six month follow-up study are which treatment components will correlate or~     which clinical treatments interventions contribute adolescent inpatients recovering in the~     psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents~     aged 13 to 18 years, with major depression and conduct disorders, and between those with and~     without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients~     recovered?~   "
102951|NCT01709513|"~     This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,~     multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus~     ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high~     CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the~     population selected in the study is a truly statin intolerant population by assessing~     skeletal muscle-related adverse events.~   "
102952|NCT01709500|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study~     alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia~     (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).~   "
102953|NCT01709487|"~     First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal~     chemotherapy (HIPEC) after optimal debulking.~   "
102954|NCT01709474|"~     The primary objective of this study is to evaluate the effects of 18 weeks of high-dose~     vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune~     function, glucose homeostasis, and bone metabolism in children with systemic lupus~     erythematosus (SLE) and serum 25-hydroxyvitamin D [25(OH)D] levels ≤20 ng/mL.~   "
102955|NCT01708499|"~     Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits~     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,~     immediately post-treatment, and at each follow-up visit.~   "
102956|NCT01708486|"~     Patients' satisfaction with their asthma medication devices is usually decided by using~     properly designed questionnaires. These questionnaires are to be used to evaluate patients'~     opinion, which is considered very important for the selection of a device.~      The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed~     to assess the patient opinion regarding the satisfaction and usability of the inhalers~     irrespectively of the drug used. It consists of 10 question each with 5 possible responses~     on a 5-point Likert scale scored from 5 to 1, respectively. The total score can range~     between 10 and 50. The higher the score, the higher the feeling of patient satisfaction from~     the inhaler.~   "
102957|NCT01708473|"~     This study will compare the effectiveness of two pain medications for reducing discomfort~     during an Ultherapy treatment.~   "
102958|NCT01708460|"~     Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to~     one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90~     and 180 days post-treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit.~   "
102959|NCT01708447|"~     This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for~     reducing discomfort associated with Ultherapy™ treatment.~   "
102960|NCT01708434|"~     Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30~     subjects will be enrolled. Study photos will be obtained prior to study treatment,~     immediately following study treatment, and at each post-treatment follow-up visit. Follow-up~     visits will occur at 90 and 180 days post-treatment.~   "
102961|NCT01708421|"~     The purpose of this study is to examine the phenotypic and genotypic characteristics and~     their associations with symptom clusters experienced during treatment for childhood~     leukemia.~   "
102962|NCT01709461|"~     the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects~     who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.~   "
102963|NCT01709448|"~     The purpose of this study is to determine whether a model can be created to predict the~     progression of early anal cancer precursor lesions in HIV using potential predictors such~     as: HIV treatment history, smoking history, sexual history, human papillomavirus viral load,~     human papillomavirus protein expression, and cell markers associated with progression of~     HPV-related lesions.~   "
102964|NCT01709435|"~     This phase I trial studies the side effects and best dose of cabozantinib S-malate in~     treating younger patients with solid tumors that have come back or no longer respond to~     treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
102965|NCT01709422|"~     The purpose of this study is to compare efficacy and safety of combination of propofol and~     midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP~   "
102966|NCT01709409|"~     The purpose of this study is to see if a medication called Curosurf can reduce the length of~     time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,~     stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a~     medication that is already used in other countries around the world but not yet in Canada.~      Babies born under 32 weeks of gestation frequently need respiratory support after birth,~     including being placed on a breathing machine or respirator. The most common reason is~     Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant,~     a soapy like substance that helps the air sacs open and close. Our current standard~     treatment is a surfactant called BLES. Curosurf contains more active ingredient per volume~     therefore the amount is smaller. The investigators hypothesize that babies who receive~     Curosurf will be able to be removed from the ventilator sooner.~      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the~     investigators will monitor their progress during their Neonatal Intensive Care Unit~     admission.~      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra~     tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this~     study.~   "
102967|NCT01709396|"~     Acute myeloid leukemia (AML) is a rapidly fatal malignancy of the bone marrow. It can be~     treated with chemotherapy alone, in some cases, but in the majority of cases, the only~     treatment that can cure the disease is an allogeneic stem cell transplant, with a cure rate~     of 30-40%. In another subset, the disease is less responsive to chemotherapy and in these~     aggressive forms, its cure rate is no better than 20% beyond 2 years, and is usually rapidly~     fatal within 6 months.~      Therefore, for this most aggressive form of the disease, modifications to the transplant~     protocol are required in order to try to improve on these poor results. There are a number~     of areas within the transplant protocol on which modifications can be made in order to~     achieve these goals. These include: higher doses of chemotherapy and or radiation;~     alterations of the new bone marrow graft; and alterations of the immune suppression,~     enhancing the graft vs. leukemia effect. By focusing on one or more of these components, one~     might be able to enhance the anti-leukemic aspect of the treatment resulting in a more~     successful outcome.~      One aspect the investigators, in Ottawa, have focused on is the initial intensive~     conditioning regimen, specifically the radiation component. It is the investigators belief~     that in the most resistant disease it is important to use the highest tolerable~     anti-leukemic treatment upfront, specifically, enhancing the radiation component of the~     initial conditioning regimen. Previous studies have suggested that higher doses of radiation~     might be more effective at eliminating the disease, however, toxicity and logistics of~     delivering the radiation have limited its use. Technical advances in the delivery of~     radiation have now permitted the safer use of high doses of radiation.~      Through modifications to the transplant procedure, the investigators believe that they can~     deliver higher doses of radiation safely and this will translate into improved outcomes in~     this high-risk subgroup of patients with AML.~      Study Objectives~      The goal of this study is to determine if a total dose of 18Gy ED-TBI followed by an~     alloHSCT for patients with refractory AML will result in an improved progression-free~     survival.~   "
102968|NCT01709383|"~     This study tests whether weak electrical stimulation of the brain is effective in improving~     language or reading difficulties occurring after a brain injury or stroke.~   "
102969|NCT01709370|"~     This is a phase II study evaluating the efficacy and safety of the pre-operative use of~     letrozole plus PD 0332991 (combination therapy)~   "
102970|NCT01709357|"~     The purpose of this study was to investigate the short and medium-term effects of three~     manual techniques on cervical range of motion and pressure pain sensitivity in subjects with~     mechanical stress, presenting latent trigger point of upper trapezius muscle.~   "
102985|NCT01709162|"~     The purpose of the study is to determine whether additional doses of ipilimumab have a~     positive effect on survival in the treatment of advanced melanoma that has progressed after~     successful initial treatment with ipilimumab.~   "
102971|NCT01709344|"~     Older adults who are treated for cancer are at risk of developing disabilities due to the~     symptoms of cancer and the side effects of treatment. Disability occurs when a person has~     trouble performing the activities he or she needs to do in everyday life. For example,~     fatigue and pain can make it difficult for an older adult to do housework, leisure, or~     volunteer activities. Disability makes it harder for older adults to stay active and be~     productive members of the community, and it can increase the costs of healthcare.~      Current approaches to cancer rehabilitation focus on using exercise, education, and social~     support to reduce cancer treatment side effects. These are important strategies to reduce~     disability, yet some side effects persist despite best efforts to resolve them. To fully~     reduce disability, people often need to adapt their activities or the environments in which~     they are performed.~      The goal of this study is to test an occupational therapy (OT) intervention that teaches~     activity planning skills to foster survivors' ability to adapt activities, routines, and~     environments in order to minimize disability. The project targets adults over the age of 65~     who are experiencing disability during or after cancer treatment. The project has two~     stages. First, twelve older adult cancer survivors will individually participate in the~     community-based intervention. After they have completed the program the investigators will~     revise the intervention to emphasize what they found most effective and helpful, and to~     eliminate aspects of the intervention that are perceived as unhelpful or redundant. The~     research question for this first stage of the project is, To what degree is it feasible for~     survivors to enroll in the study, complete the six-week intervention, and complete the three~     outcome assessments? In the second stage of the project, the investigators will test the~     revised intervention, comparing it to conventional care. The research question for the~     second stage of the project is, Do the people receiving the intervention have higher~     activity levels, greater behavioral activation, lower levels of disability, and better~     quality of life compared to those people who receive traditional cancer care? The~     intervention is appropriate for people who have been diagnosed with any type of cancer. It~     is designed to focus on whatever activities are most important to each participant. The~     novelty of the proposed intervention lies in the combination of the OT strategies of~     activity and environmental adaptation with explicit training in activity planning to teach~     survivors to find creative ways to engage in valued activities (e.g., taking care of one's~     home and family members, and participating in leisure, community, social and work~     activities). If the intervention is effective in reducing disability, it will give us~     another tool to reduce the impact of cancer on the daily lives of cancer survivors.~   "
102972|NCT01709331|"~     This study will assess if corifollitropin alfa (MK-8962), when administered in combination~     with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who~     remain azoospermic after treatment with hCG alone.~      Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase~     in testicular volume from Day 1 to Week 52 is greater than one.~   "
102973|NCT01709318|"~     The study is designed to the evaluate ovulation inhibition, vaginal bleeding, and~     pharmacokinetics associated with three different doses of two next generation vaginal rings~     (NGRs), identifying at least one whose control of menstrual cycles is not inferior to that~     of NuvaRing®.~   "
102974|NCT01709305|"~     To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus~     metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes~     Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic~     agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary~     hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in~     hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or~     (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of~     participants receiving glimepiride added to sitagliptin and metformin combination. The study~     would be declared successful if at least one of the three primary hypotheses was met.~   "
102975|NCT01709292|"~     The goal of this clinical research study is to learn about how vemurafenib may affect~     certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be~     related to your reaction to the study drug. The safety of this drug will also be studied.~      Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and~     cancer growth. By blocking this mutation, the drug may kill the cancer cells with the~     mutation and/or stop the tumor from growing.~   "
102976|NCT01709279|"~     Mesenchymal stem cells have capability to differentiate into myocardium, vascular~     endothelial cell, vascular smooth muscle cell and will be useful for heart regeneration.~     Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow~     tissue. In this trial, eligible ischemic heart failure patients will be proceeded~     intracoronary administration of autologous adipose tissue derived stromal cells by cardiac~     catheterization.~   "
102977|NCT01709266|"~     Background:~      The incidence of gastrointestinal infections is very high. In Western countries at least 30%~     of the population suffers from at least one food-borne infection per year. Mostly because of~     the problem of antibiotic resistance, more emphasis is put on prevention of infections. One~     of the possibilities is to strengthen human resistance to gut infections by consumption of~     probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus~     Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a~     probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the~     duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed~     synergistic effects compared with administration of solely S. boulardii or a mixture of L.~     helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S.~     boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced~     diarrhea in humans.~      Aim:~      To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli~     (ETEC).~      Study design:~      The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with~     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs~     placebo on several infection markers in response to an ETEC challenge is investigated.~     Participants will be randomly assigned to the probiotic or placebo group (n=30 per group).~     Subjects will be instructed to maintain their usual pattern of physical activity and their~     habitual food intake, but to standardize their dietary calcium intake. After an adaptation~     period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC~     vaccine (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and~     after infection, a diary will be kept to record all food and drinks consumption (2x2 days)~     to assess the habitual dietary intake, as well as for daily recording of bowel habits and~     frequency and severity of gastrointestinal complaints. The following biological samples will~     be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces.~     Blood is sampled for immune response analyses and the fecal samples are collected to~     quantify several infection- and immune system markers, to determine probiotic excretion, and~     to verify dietary calcium intake.~      Study population:~      Healthy males of 20-55 yrs of age.~      Interventions:~      Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU;~     twice daily) or placebo (capsules with carrier material powder of identical appearance)~      Primary outcomes:~      Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day).~      Secondary outcomes:~      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal~     complaints, relative fecal wet weight.~      Tertiary outcomes:~      sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens~     in the endogenous microbiota.~   "
102978|NCT01709253|"~     Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma~   "
102979|NCT01709240|"~     The purpose of this study is to assess the safety and performance of the BioWeld1 System~     procedure for surgical incision closure of the skin in women scheduled for elective~     C-section procedure.~   "
102980|NCT01709227|"~     Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and~     associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to~     attain negative fluid balance due to AKI induced oliguria, but have not been compared~     prospectively. The investigators will prospectively compare outcomes of infants with~     oliguria after CPB randomized to PD vs. furosemide with the hypothesis that infants~     receiving PD have superior outcomes.~   "
102981|NCT01709214|"~     The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to~     placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the~     knee. This study includes a maximum 21 day Screening Period followed by a 15-week~     Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are~     eligible for the Double-blind Treatment Period will be randomized to one of following~     treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range~     (200, 300 or 400 mcg), oxycodone CR (Controlled Release) dose range (10, 20, 30, 40 or 50~     mg) or placebo.~   "
102982|NCT01709201|"~     The investigators goal is to pilot a substance use-related brief intervention (BI) for youth~     with chronic medical conditions, obtaining preliminary evidence of feasibility,~     acceptability and impacts of the approach for reducing substance use among this group.~   "
102983|NCT01709188|"~     The purpose of this project is to determine if the Musical Dual Task Training program~     improves attention control that influences measures of gait performances under dual tasking,~     balance, fear of falling, and behavioral disturbance in patients with mild to moderate~     dementia. This Musical Dual Task Training protocol is structured with musical content and~     patients are required to do musical tasks including singing and playing instruments~     contingent on visual or auditory cues while walking. This paradigm is designed to include~     music making because it involves great demands on attention and memory that might elicit~     experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to~     strengthen brain networking for attention control that consequently may improve the gait~     performances in patients with dementia, as indicated by reducing dual task cost on gait.~   "
102984|NCT01709175|"~     The purpose of this study is to compare once-a-week vs. twice-a-week strength training in~     survivors of breast and gynecologic cancer to determine which is the optimal exercise~     prescription.~   "
102988|NCT01709123|"~     6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces~     the devastating complications that result from poorly controlled diabetes. However, for many~     patients, achievement of tight glucose control is difficult with current regimens. Trivalent~     chromium, the form found in foods and dietary supplements, is believed to be safe. Our~     preliminary studies have reported that chromium supplementation inhibits the increase in~     pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and~     IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,~     animal studies have shown that chromium niacinate supplementation lowered blood levels of~     glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines~     are proteins that are secreted by monocytes and other cells in response to various stimuli,~     such as infection. Some of the cytokines are known to regulate insulin sensitivity and~     elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,~     chromium supplementation may increase insulin sensitivity and glycemic control in diabetic~     patients, and may prevent the development of cardiovascular disease in diabetic patients.~     Given the enormous public health cost of diabetes, the prospect of being able to use a~     relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in~     achieving normal blood glucose level merits further study.~      We will examine the effects of placebo and chromium niacinate supplementation on the fasting~     glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic~     patients. We will determine these above parameters at baseline and after the 1, 2 and 3~     months of supplementation in diabetic patients. The long-term objective is to explore the~     efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the~     development of cardiovascular disease (CVD), and improve the life expectancy in diabetic~     population.~      Chromium supplements are widely used by the public and are available in many stores, such as~     Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace~     metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an~     essential vitamin for our body. This study plans to use chromium niacinate, a complex of~     chromium and niacin. Chromium niacinate is considered a nutrient.~   "
102989|NCT01709110|"~     The primary purpose of participation in this study is to answer whether teriparatide is~     superior to risedronate in reducing the occurrence of new vertebral fractures during 24~     months of therapy.~   "
102990|NCT01709097|"~     Background:~      Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ~     transplant. Patients need to take their prescribed medications and attend their appointments~     with the doctor.~      Based on previous studies in other European countries, the cost of non-compliance after~     organ transplantation in Sweden is >SEK 35 million/year.~      Patients who lose their graft both lose quality of life and have decreased expected~     survival; moreover, retransplantation may be hampered by new HLA antibodies.~      Question:~      The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed~     medication regimen in renal transplant patients.~      Methods and materials:~      All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given~     information about the study and will then be asked to participate. Participants will be~     randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included~     patients will be closely monitored for 1 year regarding intake of prescribed medications.~      Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each~     occasion when the patient takes medications from the dispenser. It has a SIM card and text~     messaging capabilities.~      Addoz Portal™ is a web-based application that makes it possible to monitor and analyse~     medication intake. Each event in the medication dispenser is registered in the portal, which~     communicates with the care provider/support person by text message, e-mail or telephone.~      Significance of the study:~      In the future it may be possible to improve compliance in transplant patients. In~     particular, patients will feel secure since they will receive confirmation through the~     portal that they are taking their medications safely and accurately.~   "
102991|NCT01709084|"~     The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to~     standard treatment) in terms of the percentage of patients who have plasma human~     immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per~     mL after 48 weeks of randomized treatment with tenofovir disoproxil~     fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).~   "
102992|NCT01709071|"~     A new inactivated polio vaccine based on attenuated poliovirus strains was developed to~     transfer the technology to manufacturers in low- and middle-income countries. This vaccine~     was produced in different dosages and in different formulations. In healthy adults the~     safety of the highest dose was comparable to that of the existing inactivated polio vaccine.~     The purpose of this trial is to determine the safety of the different dosages and~     formulations of the vaccine in infants. The second goal of this study is to analyse the~     immune response after three doses in infants.~   "
102993|NCT01709058|"~     This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of~     back pain in subjects aged 65 or older. In particular, the intramuscular injection~     technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect~     to intradiscal infiltration/intraforaminal technique, will be used.~   "
102994|NCT01709045|"~     The possibility to identify the risk of rupture of a carotid plaque will have tremendous~     impact in clinical decision making. A vulnerable plaque is considered to have a large lipid~     rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells,~     intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to~     validate imaging of plaque vulnerability with histology. Previous studies have evaluated the~     use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation~     between imaging and histology and/or clinical characteristics. However, they have focused on~     single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography~     (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small~     cohorts~      The primary goal of this study is to investigate whether there is a correlation between~     neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic~     contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the~     correlation between the volume of the LRNC as determined by dual-energy CT and histology.~      Secondly, the investigators will investigate the correlation between the volume of the LRNC,~     the fibrous cap status and the volume of the calcifications determined by MRI versus~     histology, the correlation between number of microembolisms and fibrous cap status and the~     correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.~      The imaging parameters showing good correlation with plaque vulnerability characteristics~     can be used for further analysis in assessing the vulnerable plaque~   "
102995|NCT01709032|"~     We hypothesize that the combination treatment with deferasirox and deferiprone will be well~     tolerated and will result in significant improvement in cardiac and liver iron levels.~   "
103031|NCT01708564|"~     This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose~     levels. The results will help identify the most optimal doses to take forward to the Phase~     2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with~     rhFVIIa.~   "
102996|NCT01709019|"~     Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is~     anticipated that some of the randomized study subjects may not complete the study; subjects~     who withdraw or are discontinued, will not be replaced. Randomization will be stratified by~     age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons~     in each age group equally across treatment groups.~      Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine~     on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A~     rescue dose of the licensed TIV will be provided to subjects in all groups except the~     placebo group on Day 28, the placebo group will receive saline. For each subject, study~     follow-up will span approximately one year from the first immunization (on Day 0) for all~     subjects.~   "
102997|NCT01709006|"~     It is currently estimated that above 50% of new cancer cases are diagnosed in the elderly~     population[1]. With the increased life expectancy in the industrialised countries, the~     incidence of head and neck cancers has significantly increased in the last decade with rates~     estimated between 24-40% in patients over 70 years old [2-4]. It is estimated that with the~     improvement in quality of life and treatment modulation, the incidence will continue to rise~     in the coming years. Because the current available prospective studies often exclude~     patients above 65 or 70 years old, the data and guidelines on head and neck treatment for~     these patients population remain limited.~      Treatment of elderly patients with advanced stage III-IV oropharyngeal squamous carcinoma~     with intensity modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a~     dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions to the first~     disease-free lymphatic relay bilaterally as well as a combination Cisplatin chemotherapy at~     a reduced dose.~   "
102998|NCT01708993|"~     The purpose of this study is to find out if giving reolysin in combination with docetaxel or~     pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed~     alone.~   "
102999|NCT01708980|"~     Background:~      In the early phase after a total knee replacement (TKA), patients experience multi-level~     weakness in the operated leg, which is caused primarily by reduced central (CNS) activation~     failure of the muscles - especially the knee extensors. This considerable loss of muscle~     strength relates to reduced functional performance. The investigators recently reported that~     early-commenced physiotherapy, including progressive strength training performed in~     machines, seems feasible after TKA. The question is, if neuromuscular activity of the~     muscles in the operated leg, elicited during strength training in machines, can be reached~     during strength training in more simple forms? Many clinicians are faced with the problem of~     not having strength training equipment at their institution, or having to prescribe simple~     strength training exercises for home-based training.~      Purpose and hypothesis:~      The purpose of this study is to determine which strength training exercises that activate~     the muscles in the operated leg the most after TKA. The hypothesis is that strength training~     exercises performed in machines is more effective compared to strength training performed in~     more simple forms (using elastic bands or own body weight, etc.).~      Participants and methods:~      Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first~     investigation, will be included. The participants are investigated twice. During the first~     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a~     load that can be lifted exactly 10 times) will be determined for all the exercises. At least~     72 hours later, the participants will undergo an electromyographic analysis, which~     determines the neuromuscular activity of the thigh muscles in the operated leg.~      Ethical issues:~      From a pilot study, the investigators found that strength training exercises commenced early~     after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain.~     None of the financial supporters, or any of the authors, have any potential conflicts of~     interest with regard to the study.~   "
103000|NCT01708967|"~     This study designed for compare efficacy of following two anesthetic method for transnasal~     endoscopy~        -  Catheter-free method~        -  Catheter-insertion method~   "
103001|NCT01708954|"~     This randomized phase II trial studies how well giving erlotinib hydrochloride and~     cabozantinib-s-malate alone or in combination works as second or third line therapy in~     treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and~     cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together~     with cabozantinib-s-malate is more effective than erlotinib hydrochloride or~     cabozantinib-s-malate alone in treating non-small cell lung cancer.~   "
103002|NCT01708941|"~     This randomized phase II trial studies how well ipilimumab with or without high-dose~     recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that~     cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor~     growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the~     growth of tumor cells. It is not yet known whether ipilimumab is more effective with or~     without high-dose recombinant interferon alfa-2b in treating melanoma.~   "
103003|NCT01708928|"~     Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the~     lower two thirds of the face and neck. Subjects will be equally grouped into those with a~     history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or~     rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following~     treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at~     each follow-up visit.~   "
103004|NCT01708915|"~     The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide~     ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of~     acute low back pain.~   "
103005|NCT01708902|"~     Reduced factorial design study with 24 week randomized treatment of initial combination~     therapy with linagliptin and metformin in T2DM patients~   "
103006|NCT01708889|"~     The purpose of this study is to determine the effect of renal impairment on pharmacokinetics~     (PK) of BMS-914143.~   "
103007|NCT01708876|"~     Preliminary studies have supported the background efficacy of local standard anti-malarial~     medications in the treatment of uncomplicated knowlesi malaria, however this has not been~     tested systematically and there are no current WHO treatment guidelines for this infection.~     There are both health cost benefits to a more rapidly acting agent, and due to difficulties~     with microscopic identification there may be more effective treatment for all malaria~     species if an aligned treatment guideline could be supported. In addition, no therapeutic~     efficacy monitoring of current first line anti-malarials used for the treatment of P. vivax~     malaria have been conducted in Malaysia.~      The investigators aim to test whether the fixed combination of artesunate-mefloquine is~     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.~     knowlesi and P. vivax infection in both adults and children in this region.~   "
103222|NCT01705990|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly~     in prime-boost regimens in HIV-uninfected, healthy adult volunteers.~   "
103008|NCT01708863|"~     Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that~     consists of multiple obstructions to flow through the left heart and aorta, as well as~     hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol~     starting within days of birth. Stage I of this process is the Norwood reconstruction (within~     the first few days of life), Stage II (usually required within 3-8 months) involves creation~     of a direct connection between the patient's superior vena cava and the pulmonary arterial~     confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan~     circulation (typically within the first 2-4 years). This single ventricle approach~     requires the right ventricle to perform as the only circulatory pump for the entire body.~      Our long-term goal is to develop regenerative strategies to strengthen and augment the right~     ventricular muscle of the single-ventricle heart following surgical palliation in HLHS~     patients. To determine the safety and feasibility of a cell-based therapeutic intervention~     at the Stage II surgery, we aim to document the natural history of post-surgical care in~     HLHS patients having undergone standard of care with protocol specific follow-up over the~     course of a 6-month period.~      This prospective study will document the natural history in patients with HLHS after planned~     Stage II surgical palliation with a focus on cardiovascular parameters within 6 months~     following surgery in 10-20 patients.~   "
103009|NCT01708850|"~     Patients with cancer and an upper extremity DVT associated with a central venous catheter~     (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates~     with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes~     including bleeding and recurrent venous thromboembolism.~      The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT~     secondary to central venous catheters in patients with active malignancy is an effective~     therapy as quantified by the success of catheter preservation. Prolonged line salvage rate~     without recurrence of UEDVT will improve the management of cancer patients who develop an~     upper extremity deep venous thrombosis in the setting of a central venous catheter.~   "
103010|NCT01708837|"~     The purpose of this study is to investigate whether the depth of anesthesia with propofol~     affects the incidence of early postoperative cognitive dysfunction~   "
103011|NCT01708824|"~     Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong~     Kong. A recent report concluded physical activity (PA) protects against colon cancer and~     foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of~     lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is~     largely unknown.~      Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural~     interventions for CRC survivors intended to improve cancer outcome and designed to (1)~     increase PA levels and (2) reduce consumption of a Western diet.~      The investigators hypothesize that the proposed interventions are (1) efficacious in~     changing the two targeted behaviours; and (2) acceptable to CRC survivors.~      Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors~     within 12 months of completion of cancer treatment and without evidence of~     persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after~     informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted~     behaviours prescribed over 12 months. Primary outcome measure is whether the target levels~     of PA and dietary intake could be met at the end of intervention. Secondary outcome measures~     include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and~     determinants of compliance; (3) facilitators and barriers to behavioural change; (4)~     measurement of theoretical constructs underlying PA and dietary interventions; (5) possible~     health benefits and side effects (PA-associated injury and nutritional deficiency) arising~     from the interventions. Outcome will be assessed at baseline, 6 months into intervention and~     then at 0, 6 and 12 months post-intervention.~      Impact - If proven feasible, our intervention programme would pave way for a large~     randomized controlled trial testing the effect of PA and diet on the treatment outcome of~     CRC.~   "
103012|NCT01708811|"~     Hyponatremia during labour has been associated with prolonged labour, and increased~     incidence of instrumental delivery and emergency caesarean section. Sodium influx in~     myometral cells are involved in contractility,and and influence of hyponatraemia on~     contractility can be suspected.~   "
103013|NCT01708798|"~     Doxorubicin and other anthracyclines are commonly used to treat breast cancer and other~     types of cancer. Unfortunately, they can cause heart muscle damage, resulting in scarring,~     abnormal contraction and relaxation, and heart failure symptoms. This side effect occurs~     more frequently at higher doses, and limits the total dose that can be given to cancer~     patients. Eplerenone is an oral medication that prevents or reverses heart damage in other~     disease states, and is commonly used to treat heart failure. This study will investigate the~     use of eplerenone to protect the heart from these harmful side effects of doxorubicin.~      Few therapies have been shown to prevent heart damage in patients receiving anthracyclines.~     Small studies have suggested that other heart failure medications (ACE inhibitors,~     beta-blockers) may reduce the incidence of cardiac toxicity, but eplerenone and other drugs~     in its class (aldosterone antagonists) have not previously been studied. Eplerenone inhibits~     enzyme pathways that cause scarring of the heart, and animal studies suggest that~     anthracyclines cause damage through these same pathways.~      This study aims to investigate whether eplerenone protects the heart from the harmful~     effects of doxorubicin chemotherapy. Specifically, it will measure the effect that~     eplerenone has on heart muscle relaxation. It will randomly assign women undergoing~     chemotherapy with doxorubicin to one of two groups: one group will receive eplerenone, and~     the other group will receive placebo (sugar) pills. The subjects will not know which type of~     pills they are taking. Heart muscle relaxation will be measured at baseline, after~     completion of chemotherapy (8-12 weeks), and after 6 months. There will also be various~     blood tests measured in the study subjects, to determine whether there might be certain~     blood tests that identify patients at particularly high risk of heart toxicity after~     doxorubicin therapy.~   "
103014|NCT01708785|"~     The purpose of this study is to optimize an obesity treatment program targeting overweight~     8-12 year old children using Cue Exposure Training.~   "
103015|NCT01708772|"~     A total of ninety patients (52men and 38women) were included in the study. Forty five~     patients developed septic complication during ICU stay (sepsis group). Forty five patients~     were critically ill without evidence of infectious organism (SIRS group). At admission,~     Patients data include clinical status; SOFA score; central venous pressure; laboratory~     analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The~     attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as~     long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.~   "
103016|NCT01708759|"~     One hundred eighty critically ill African adult intensive care patients divided into two~     groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic~     critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and~     SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.~   "
103045|NCT01708291|"~     This project will measure baseline stress among a group of youth in foster and kinship care.~     The investigators will implement a pilot program to target stress reduction by using an~     evidence-based group therapy technique teaching mindfulness skills. The investigators~     hypothesize that the mindfulness skills will help youth to reduce stress, which will be~     measured using psychological and physiological techniques.~   "
103267|NCT01705405|"~     Visualize surgical needles inserted in the prostate, under the ultrasound modality.~   "
131090|NCT01339559|"~     This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and~     single arm study of brivaracetam (BRV).~   "
103017|NCT01708746|"~     This is a prospective, single-institution observational study to be conducted at 4 clinics~     within the Southern California Permanente Medical Group. Pregnant women who present for~     prenatal genetic counseling at the designated clinics and who meet study eligibility~     criteria will be offered the option of the verifi® prenatal test by a trained, licensed and~     certified genetic counselor (GC) . Women who elect the verifi® prenatal test will have a~     blood sample drawn by peripheral venipuncture that will be sent to the Verinata Health~     CAP-accredited clinical laboratory (Redwood City, CA). Results will be reported to the~     ordering health care provider by the laboratory within 8-10 business days and will be shared~     with the subject by their provider. Subject care and decision-making following NIPT result~     will be clinically managed by the provider with his/her subject and is not dictated by the~     study protocol. All eligible women who provide informed consent, whether they elect or~     decline NIPT will be asked to complete a short questionnaire on their views of prenatal~     testing. The uptake of invasive prenatal procedures (CVS and/or amniocentesis) by the total~     prospective cohort will be collected through review of electronic medical records (EMR). A~     historical cohort with matched demographic and pre-test indications to the prospective~     cohort will be identified from the EMR for comparison in the primary analysis.~   "
103018|NCT01708733|"~     The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on~     HCV Carrier With Abnormal Liver Function.~   "
103019|NCT01708720|"~     The purpose of this trial is to determine whether the new inactivated polio vaccine that is~     based on attenuated poliovirus strains is safe and to evaluate the immune response in~     healthy adults.~   "
103020|NCT01708707|"~     The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost~     effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence~     Syndrome (NAS).~   "
103021|NCT01708694|"~     The purpose of this study is to determine the effect of a slowly digesting starch on gut~     bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with~     pre-diabetes.~   "
103022|NCT01708681|"~     Despite numerous studies of meal components in humans, little is still known about how~     different meals influence on metabolism. The purpose of this study is to a gain knowledge of~     how a balanced test meal with either lean seafood (example:cod) or meat as the main protein~     source will:~        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)~        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at~          end of intervention period)~        3. affect gut microbiota composition~   "
103023|NCT01708668|"~     Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent~     epidural injections appear to reduce the incidence of maternal intra-partum fever compared~     to continuous epidural infusion during labor analgesia. However, the optimal combination of~     bolus volume and administrating interval has not yet been compared. The purpose of this~     prospective, randomized, double-blind trial was to determine how intermittent epidural bolus~     reduced the incidence of maternal intra-partum fever compared with continuous epidural~     infusion during labor.~   "
103024|NCT01708655|"~     The investigators hypothesize that measurement of beta adrenergic induced sweat rate using~     an evaporimeter can accurately and reliably determine different levels of CFTR dysfunction~     within a spectrum of patients expressing various degrees of cystic fibrosis disease.~      The investigators overall goal is to determine whether the evaporimeter technique of~     measuring beta-adrenergic induced sweat rate is capable of accurately and reliably~     identifying different levels of CFTR dysfunction, as a prerequisite before advancing this~     technique as biomarker assay into clinical trials.~   "
103025|NCT01708642|"~     The purpose of this study is to evaluate the effect of intraoperative administration of~     low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.~   "
103026|NCT01708629|"~     The purpose of this study is to assess the safety and efficacy of brodalumab at two~     different doses compared with placebo in participants with moderate to severe plaque~     psoriasis.~      A second purpose of this study is to assess the safety and efficacy brodalumab at two~     different doses compared with ustekinumab in participants with moderate to severe plaque~     psoriasis.~      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens~     of brodalumab.~   "
103027|NCT01708616|"~     This single-center, randomized, double-blind, two-period crossover study will evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of~     multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers.~     Subjects will be randomized to one of 4 treatment sequences of two periods to receive~     multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or~     multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone~     placebo, with a washout period of approximately 3 weeks between treatment periods.~     Anticipated time on study is up to 12 weeks (from screening through study completion).~   "
103028|NCT01708603|"~     The purpose of this study is to assess the safety and efficacy of brodalumab at two~     different doses compared with placebo in participants with moderate to severe plaque~     psoriasis.~      A second purpose of this study is to assess the safety and efficacy brodalumab at two~     different doses compared with ustekinumab in participants with moderate to severe plaque~     psoriasis.~      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens~     of brodalumab.~   "
103029|NCT01708590|"~     The purpose of this study is to assess the safety and efficacy of brodalumab taken every two~     weeks at two different doses in participants with moderate to severe plaque psoriasis.~      A second purpose of this study is to assess the safety and efficacy when brodalumab is~     replaced with placebo in some participants compared with the participants who are still~     receiving the brodalumab.~   "
103030|NCT01708577|"~     The purpose of the study is to evaluate the feasibility of a new wearable computerised~     system designed for an ongoing monitoring of sportsmen under real-life conditions. This~     system consists of different sensors and Bluetooth Transmitters interconnected by wires and~     integrated in the textile of a T-shirt. Several physiologic parameters including~     bioimpedance should be investigated under conditions relevant for an intensive physical~     activity, like high body temperature or partial dehydration. This system has to be tested~     under laboratory and natural/open air conditions, the obtained evaluations compared with~     standardised established diagnostic methods.~   "
103032|NCT01708551|"~     Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in~     Groups A, B or C will undergo axillary punch biopsies during the course of the trial to~     determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm~     and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups~     A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will~     receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm~     treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J).~     Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same~     energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square;~     Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180~     days post-treatment #2.~   "
103033|NCT01708538|"~     The corneal collagen cross-linking treatment has been used with increasing success to treat~     corneal dystrophies such as keratoconus. Recent advances have allowed different techniques~     for performing this cross-linking treatment. This study investigates the effects of corneal~     cross-linking using different surgical techniques.~   "
103034|NCT01708525|"~     Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in~     tissue treated with the Ulthera® System compared to control tissue.~   "
103035|NCT01708512|"~     All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained~     pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled~     subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.~   "
103036|NCT01708408|"~     The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a~     large-scale community registry and biorepository that can be used as a vehicle for future~     health services, epidemiologic, clinical trials and other omics-related research.~   "
103037|NCT01708395|"~     The investigators believe that patients with ulcerative colitis are able to report details~     of their own medical history accurately and record changes in clinical status effectively~     over time. Using an internet-based database the investigators will ask patients to report~     their own disease history, and the investigators will compare their reports to the medical~     record.~   "
103038|NCT01708382|"~     Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on~     the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will~     be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.~   "
103039|NCT01708369|"~     The purpose of this study is to determine if alcohol is able the affect the body's ability~     to eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that~     drinking alcohol may reduce the body's ability to break down these two medications along~     with many others.This could affect the amount of drug in the blood which could impact how~     well these drugs work and whether patients have side effects.~   "
103040|NCT01708356|"~     Introduction: Cycling is currently promoted at the municipal, provincial and national level~     as a form of active transportation that increases physical activity while at the same time~     reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.~     While at a population level the health benefits of exercise via cycling are estimated to~     substantially exceed any health impacts related to air pollution exposure and injuries from~     traffic accidents , cyclists are known to experience elevated exposures to traffic-related~     air pollutants. Combined with exposure to elevated concentrations of air pollutants,~     cyclists also are subject to substantially increased inhaled doses due to their level of~     exertion and consequently increased inhalation rate. Therefore, given that cyclists~     experience exposures to relatively high concentrations of traffic-related air pollutants and~     that their inhalation of these pollutants is increased, it is important to evaluate the~     potential health impacts of this scenario. Research on the potential health impacts related~     to exercise (cycling) and urban air pollution exposure can help inform public communication~     strategies related to air quality and its health impacts. In addition, as our previous work~     suggests substantial variability in air pollution exposures to cyclists that is related to~     the route type and the levels of traffic along cycling routes, there is potential for~     transportation planners to promote increased cycling by enhancing infrastructure while at~     the same time developing routes that also minimize exposure to air pollution. The cyclist~     population is also interested in information regarding the air pollution exposures and~     potential health impacts related to cycling.~      The objective of this study is to investigate the relationship between traffic-related air~     pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.~     Specifically, the investigators propose to:~        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,~          ultrafine particulate, black carbon) while cycling along two different bicycle routes~          in the city of Vancouver;~        2. estimate the pollutant dose received by each cyclist, and relate this to the health~          effects observed; and~        3. determine if there is a change in lung function, endothelial function, and C-reactive~          protein level related to the level of air pollution exposure and dose~   "
103041|NCT01708343|"~     To test the hypothesis that the effect of either multiple deep intramuscular stimulation~     therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep~     intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a~     placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I~     for improving pain relief, sleep quality, and physical and mental state of the patient.~   "
103042|NCT01708330|"~     When a patient requires a manual vacuum aspiration (MVA), whether for an undesired~     pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional~     experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of~     an invasive and often painful procedure. Minimizing the pain during this procedure must not~     be overlooked. There have been no randomized controlled trials evaluating pain control~     during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an~     elective abortion or other office procedures.~      Women being treated at the Women & Infants Triage who have experienced a first trimester~     missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and~     are being treated with an outpatient manual vacuum aspiration will be asked to enroll in~     this study. Those who wish to participate will be randomly assigned to treatment with~     lidocaine gel or a placebo gel applied to the cervix during their procedure.~      The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.~   "
103043|NCT01708317|"~     The purpose of this study is to determine if an Audio-enhanced Computer-Assisted~     Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in~     youth visiting a pediatric ED~   "
103044|NCT01708304|"~     The University of Washington's Northwest Research Group on Aging is partnering with Area~     Agencies on Aging (AAA) in Washington and Oregon to complete this translational~     investigation of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an~     evidence-based program with demonstrated efficacy in helping older adults with dementia~     maintain physical function and remain physically and mentally healthy. This study asks two~     questions: 1) Can AAA partners successfully translate and implement RDAD, and 2) Is AAA~     implementation of RDAD effective in producing desired outcomes among agencies, providers,~     and older adults with dementia and their family members. This study is being conducted in~     Washington and Oregon states.~   "
103046|NCT01708278|"~     Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung~     parenchyma and airways, which is the third-leading cause of death in the USA. Current~     therapies for COPD are only partially effective and may also have side effects. Although~     increasing evidence indicates that quercetin supplementation may be beneficial in treating~     COPD, key methodological issues have not been resolved. The overall objective of this study~     is to determine the dosage of quercetin supplementation, bioavailability of quercetin,~     safety, dose-response relationship and appropriate biomarkers which reflect clinical~     outcomes in patients with COPD that is necessary for conducting large clinical trials in~     this patient population.~   "
103047|NCT01708265|"~     The purpose of this study is to compare early mitral valve repair versus a watchful waiting~     strategy in asymptomatic patients with severe organic mitral valve regurgitation and~     preserved left ventricular function.~   "
103048|NCT01708252|"~     Up to 10 subjects will be enrolled. All subjects will receive an increased density~     UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the~     face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images~     will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.~   "
103049|NCT01708239|"~     In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant~     patients, sequential diagnostic strategies based on 1) the assessment of clinical~     probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well~     validated.~      Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the~     management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score,~     has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule~     was derived and internally validated. A prospective validation of this rule is now~     warranted, and we plan to use it in our prospective study.~      The second step used in the diagnostic strategy including non-pregnant patients is D-dimer~     measurement. The test has been widely validated in non-pregnant patients and, in association~     with a non-high clinical probability, it allows to safely rule out DVT.~      As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and~     it is less useful in pregnant women. Data from the literature clearly suggest that the usual~     cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual~     cut-off has never been prospectively validated in pregnant women with suspected DVT, we~     would like to use it in our study.~      Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However,~     this test is not always available. Therefore, a strategy in which the association of~     clinical probability assessment and D-dimer measurement would allow to safely rule out DVT~     in a significant proportion of patients without performing a complete CUS, would be of great~     help in everyday clinical practice and would probably be cost-effective.~      Therefore, we plan a prospective study to assess the safety of a sequential diagnostic~     strategy based on the assessment of clinical probability with the LEFt rule, D-dimer~     measurement and complete CUS in pregnant women with suspected DVT.~   "
103050|NCT01708226|"~     Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues~     significant concurrent and long-term risk to affected youth. Although empirically supported~     psychosocial and pharmacological treatments for OCD exist, many children and their families~     are not able to adequately access these treatments or derive only partial benefit from them.~     Such findings highlight the importance of developing more effective treatment options which~     have the potential to be widely accessible to OCD youth.~      The investigators are proposing to test a computerized attention modification program, AMP,~     in six youth with OCD in an open case series to gather information regarding protocol~     acceptability, feasibility and preliminary efficacy. This phase includes the development and~     refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP~     parameters for use with children.~      Following ascertainment of study eligibility, participants will undergo a baseline~     assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention~     bias assessment, and self report questionnaires. Study participants will then receive 12~     sessions of AMP treatment over the course of three weeks. All youngsters and their families~     will be reassessed at treatment endpoint (week 4). Participation will take a total of about~     24 hours over the course of six weeks. Participants who are treatment responders may be~     asked to return approximately 3 months after completing treatment for a follow-up~     assessment.~      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to~     administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom~     severity.~   "
103051|NCT01708213|"~     The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as~     determined by clinical assessment of treatment sites and routine tracking of adverse events.~   "
103052|NCT01708200|"~     This study will compare the effectiveness of a psychoeducational memory program versus a~     computerized memory program in individuals with mental illness. Although improvements are~     expected with both form of interventions, we do not know which will provide maximal benefit~     in this population.~   "
103053|NCT01708187|"~     Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all~     flexor tendon repairs adhesions are one of the more common challenges after surgery.~     Peroneal tendon gliding is key to their function as effective plantar flexors and evertors~     of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory~     reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that~     allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon~     with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons~     utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane~     (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved~     Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that~     amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears,~     and adhesions.~   "
103054|NCT01708174|"~     This Phase II study evaluates the safety and efficacy of LDE225 in adult and pediatric~     patients with Hh-pathway activated, relapsed MB.~   "
103055|NCT01708161|"~     This is a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part is to~     estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the~     combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the~     clinical efficacy and to further assess the safety of the combination in selected patient~     populations. Patients will be treated until progression of disease, unacceptable toxicity~     develops, or withdrawal of informed consent, whichever occurs first. All patients will be~     followed up. At a minimum, patients must complete the safety follow-up assessments 30 days~     after the last dose of the study treatment.~   "
103056|NCT01708148|"~     The aim of this study is the improvement of the penile linked neovaginal flora in~     male-to-female transsexuals after application of oral probiotics.~   "
103086|NCT01707758|"~     The primary objective is to develop a rapid in vitro screening assay for detection of~     pancreatic cancer biomarkers in blood of patients with pancreatic cancer.~   "
103087|NCT01707745|"~     Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In~     retinopathy of prematurity (ROP).~      Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.~   "
103057|NCT01708135|"~     This current study aims to evaluate the efficacy of engagement modules in preparing patients~     for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app~     (Android and Apple compatible) has been created that will assist in both educating and~     engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to~     create a cost-effective, smartphone-based platform that serves to not only efficiently~     educate but to also verify competence and keep our patients engaged during the lengthy~     pre-bariatric surgery process.~   "
103058|NCT01708122|"~     The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl~     spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into~     the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or~     any other problems with the urinary bladder). The current standard practice is to use~     Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease~     pain. In this study, an additional medicine (fentanyl) is used to reduce pain that occurs~     during and after the above procedure.~   "
103059|NCT01708109|"~     The purpose is to study natural process of gallstones in common bile duct, stones less than~     or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The~     second outcome is to study side-effects of gallstones removed with surgery.~   "
103060|NCT01708096|"~     The aim of the study is to develop new strategies in treatment of continuous increasing~     number of patients with type 2 diabetes by understanding how bariatric surgery cures or~     improves this condition.~   "
103061|NCT01708083|"~     Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing~     laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).~      Are there any difference in polymorphids and/or mRNA expression in genes significant for~     developing obesity, between normal weight and obese individuals, with or without diabetes~     typ 2 .~      Are there any difference in polymorphids and/or mRNA expression in different types of fat~     tissue~   "
103062|NCT01708070|"~     Although depressive and anxious symptoms are common in asthma patients and are associated~     with worse clinical and resource utilization outcomes, there have been no studies focusing~     on the particular challenges of improving asthma self-management in this population. The~     investigators hypothesize that a tailored intervention to improve asthma self-management in~     patients with a known history of depressive and anxious symptoms will be effective in~     improving asthma-related quality of life.~   "
103063|NCT01708057|"~     This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the~     bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active~     comparator.~   "
103064|NCT01708044|"~     To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with~     type 1 diabetes on postprandial plasma glucose concentrations~   "
103065|NCT01708031|"~     Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological~     Signal~      The objective of this study is to induce and measure the human stress level through~     computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and~     skin temperature). Studies suggested that mental arithmetic task is one of the efficient~     stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved~     in to computerized version. The protocol will be tested with normal subjects and multiple~     physiological signals will be acquired simultaneously. The questionnaire about the subject~     experience will be obtained in order to strengthen the stress induction. The normal~     volunteer subjects will be invited for the participation this study. The physiological~     signal will be analyzed using suitable algorithm based on the characteristics of each~     signals. The multiple signal based stress level assessment system will be developed by~     training and testing the acquired data.~   "
103066|NCT01708018|"~     This study will be the first scientific approach to investigate physical and psychological~     effects of the passive hydrotherapy-method WATSU (WaterShiatsu) on women and their unborn~     children at the third trimester of pregnancy. Potential therapeutic benefits of the method~     shall be evaluated.~      It is being hypothesized that WATSU is related to measurable changes in everyday stress~     perception, psychological wellbeing, quality of life, pregnancy-related low back pain, tonus~     of the uterus, amount of amniotic fluid, spontaneous course of breech presentations,~     prospects of external cephalic versions.~      Participants in the intervention-group will be treated twice with WATSU (60 minutes per~     treatment, standardized sequence) in the >36th week of pregnancy. There will not be any~     sham-intervention in the control-group. Both groups will be examined by ultrasound (prior~     and after the treatments plus on day 8 of the trial) and answer questionnaires (prior and~     after the treatments plus once a week until birth).~   "
103067|NCT01708005|"~     The purpose of this study is to compare the effect after 12 weeks of the oral intake of~     Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive~     performance in Trial Making Test score part B (this test evaluate executive functions of~     mental flexibility) in older adults with Mild Cognitive Impairment (MCI).~   "
103068|NCT01707992|"~     This is a multinational, multicenter, randomized, double-blind, parallel-group,~     placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and~     tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2mg/day in~     subjects with RRMS.~   "
103069|NCT01707979|"~     The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR~     and impedance.~   "
103070|NCT01707966|"~     The main objective of this multicenter, randomized, double-blind, placebo-controlled phase~     III trial is to assess the impact of maintenance orteronel on disease progression and hence~     on quality of life in patients with metastatic castration-resistant prostate cancer who have~     achieved at lease disease stabilization after first line chemotherapy with docetaxel.~   "
103071|NCT01707953|"~     The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on~     reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip~     arthroplasty.~   "
103072|NCT01707940|"~     This trial investigates the influence of oral ketoconazole on the pharmacokinetics and~     safety of BI 144807.~   "
103073|NCT01707927|"~     Comparing two biological valves in a prospective randomized study. Mosaic Ultra and~     Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by~     patients with the same annulus measured by a hegar dilatator.~   "
103074|NCT01707914|"~     Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and~     cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous~     animal studies from us and other investigators, anthocyanins have been shown to ameliorate~     dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study~     was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on~     levels of biomarkers related to antioxidant status in young adults with features of fatty~     liver disease.~   "
103075|NCT01707901|"~     A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal~     pain hypersensitivity in patients with gastric reflux disease~   "
103076|NCT01707888|"~     Surgery may be the best treatment choice for early stage non-small cell lung cancer. And~     VATS major lung resection have been preferred as a standard radical procedure for early~     stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS~     major lung resection for lung cancer as a real-world study in china.~   "
103077|NCT01707875|"~     Fetal brain asymmetry is considered a normal developmental processes. The size and shape of~     the lateral ventricles are interdependence with the brain parenchyma. Abnormal development~     of the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral~     ventricle measurement is one of the most frequently used sonographic tool for the evaluation~     of brain development. It is easier to evaluate and measure the distal cerebral ventricle,~     and therefore data concerning the normal range of asymmetry and the normal progress of the~     asymmetry are limited.~      The objective of the study is to follow up the incidental finding of fetal ventricle brain~     asymmetry between 19-30 weeks of pregnancy.~   "
103078|NCT01707862|"~     Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle~     tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least~     70 cases. Most are individual case reports. Surgical experience is not much. However,~     different opinion of surgical strategies remain controversial. The purpose of this report is~     to describe our experience of surgical management for the IVL with intracardiac extension.~   "
103079|NCT01707849|"~     Background:~      Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients,~     associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20%~     of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and~     graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of~     HCV-infected LT recipients is shorter than that of uninfected LT patients.~      New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk~     of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence.~     Moreover new directly-acting antiviral agents have increased efficacy of interferon-based~     treatment but their use in LT recipients may be limited by side effects.~      Hypothesis:~      Use of individualized immunosuppressive regimen and early personalized anti-viral treatment~     based on recipient and viral factors would improve outcome of HCV infected liver transplant~     recipients.~      Objectives:~        1. To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to~          reduce hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK~          score) at one year post-transplant.~        2. To identify viral and recipient factors associated with liver fibrosis progression~          using ultra-deep pyrosequencing (UDPS).~   "
103080|NCT01707836|"~     This study will analyze DNA samples to determine associations between maternal and offspring~     genetic factors and pediatric brain tumor development in children with Neurofibromatosis~     Type 1. Participating families (mother, father, child) will be asked to complete a short~     questionnaire and provide DNA samples (either saliva or blood). The information gained from~     your participation may one day help doctors develop strategies to reduce brain tumor risk in~     individuals with NF1. Please note: there is no therapy associated with this study.~   "
103081|NCT01707823|"~     This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with~     stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients~     with cancer in the laboratory may help doctors learn more about changes in biomarkers that~     occur during treatment with acetylsalicylic acid~   "
103082|NCT01707810|"~     METHODS: Patients were submitted to conventional (n=15) or piggyback (n=17) liver~     transplantation (LTx). Free hepatic vein pressure (FHVP) and the central venous pressure~     (CVP) measurements were performed after graft reperfusion. Postoperative (PO) serum~     creatinine (Cr) was measured, acute renal failure (ARF) was defined as Cr > or = 2,0mg/dL~     and PO renal function was analyzed by modificated RIFLE-AKIN. PO overall Cr was calculated~     by area under the curve (AUC) of Cr vs. time. on the first week.~   "
103083|NCT01707797|"~     The study aims to develop a questionnaire that can be used to help uncover a child's risk of~     developing dental caries (also known as tooth decay or a cavity). The aim is to develop a~     practical and easily-scored risk tool that a primary medical care provider can use to help~     find young children with the highest risk for developing cavities.~   "
103084|NCT01707784|"~     The objective of the study is to investigate the effect of stress on glucose tolerance~     during pregnancy.~      The main objectives of the study are to investigate if various measures of stress (stressful~     life events, the perceived level of stress and the cortisol or copeptin concentrations)~     differ between pregnant women with and without gestational diabetes during the end of the~     second/beginning of the third trimester when presenting for their routine glucose tolerance~     testing.~      Secondary objectives are the link between these different stress measures and the routinely~     measured fasting and stimulated glucose levels during the oral glucose tolerance test.~   "
103085|NCT01707771|"~     Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its~     Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a~     hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as~     well as insulin sensitivity after interventions.~      Summary Background Data: Very few prospective uncontrolled studies have investigated the~     effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled~     studies had as primary goal the changes in HDL-cholesterol after gastric bypass.~      Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were~     enrolled.~      Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions~     and medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).~   "
103088|NCT01707732|"~     Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a~     common medical condition encountered during hospitalization in a medical environment. The~     use of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has~     reduced more than 50% relative risk of thromboembolic complications.However, while obesity~     defined by a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous~     thrombotic events, data on obese patients are limited. In fact, less than 20% of patients~     included in the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most~     studies specific to the obese population comes from a series of bariatric surgery patients~     or orthopedic surgery. The main results of this series show regarding the obese population a~     decrease of the anti-Xa activity during the administration of a standard dose of enoxaparin~     (40 mg / d). However, no specific recommendation in this population has not been published~     to date and therefore,the dosages currently used are the same regardless of the patient's~     weight. In this context, the use in obese patients hospitalized in a medical environment a~     stronger dosage of enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day,~     could get rates anti-Xa activity levels more consistent with the treatment required, and~     thus reduce the risk for thromboembolic complications in these patients~   "
103089|NCT01707719|"~     High lipid peroxidation and altered antioxidant defenses have been frequently reported in~     Alzheimer's disease patients.~      The purpose of this study is to investigate susceptibility to photo-oxidation of isolated~     erythrocyte membranes, in patients affected by Alzheimer's disease and age- and sex-matched,~     non demented subjects.~   "
103090|NCT01707706|"~     The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment~     on residual insomnia in major depressive patients.~   "
103091|NCT01707693|"~     Making physical activity an integral part of daily life is imperative to the health and~     well-being of our nation's older adults. However, no intervention strategy to encourage~     daily physical activity for older adults, especially older women, has been effective. This~     feasibility study will test a multi-tailored motivational intervention to increase usual~     lifestyle physical activity of older sedentary women to reduce their coronary heart disease~     risks.~   "
103092|NCT01707680|"~     The purpose of this study is to determine whether the use of different sedatives affect the~     weaning process from mechanical ventilation in intensive care patients.~   "
103093|NCT01707667|"~     To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor~     activity in subjects that are chronically constipated.~   "
103094|NCT01707654|"~     A combination of soft tissue and digital nerve defects in the finger results in sensory loss~     of the finger pulp. Reconstruction of these combined injuries is difficult. When the~     neurocutaneous defect is associated with wound infection, reconstructive alternatives are~     more limited. From July 2008 to May 2010, a retrospective study was conducted with 9~     consecutive postinfection patients who had the neurocutaneous defect of the finger following~     trauma. The purpose of this retrospective study is to report repair of the complicated~     infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of~     this technique.~   "
103095|NCT01707641|"~     Oral mucositis is a debilitating side effect for oncology patients and there is a clear need~     for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a~     potential new alternative for the prevention of grade III and IV mucositis. The main~     endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the~     incidence of grade III and IV mucositis as well as increase the percentage of patients who~     will complete the radio-chemotherapy treatment.~   "
103096|NCT01707628|"~     The purpose of this study is to compare the number of responders to vaccination with the~     influenza virus vaccine at different time points after last dose of rituximab in patients~     with lymphoma. Secondly to study the immune-response to vaccination with influenza virus~     vaccine, after treatment with rituximab in relation to the reconstitution of~     immune-function.~   "
103097|NCT01707615|"~     The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical~     use~   "
103098|NCT01707602|"~     The project aims to evaluate the impact of skin routes of immunization (transcutaneous and~     intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza~     vaccination in adults (18-45 years old).~   "
103099|NCT01707589|"~     the investigators are assessing a non-invasive monitor based on dynamic light scattering~     that measures pulse rate and respiration rate. The monitor also will be equipped with a~     temperature sensor and a motion sensor. This monitor will allow multi-parametric~     measurements in neonates in a simple and noninvasive manner.~   "
103100|NCT01707576|"~     The primary purpose is to estimate the prevalence of depression and subsyndromal states~     among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for~     they are another way of tracking this suffering, as they host many troubled teens at once~     for health problems and accidents sometimes iterative, reflecting their risk behaviour.~      Secondary purposes are to assess the feasibility and desirability of a post-emergency~     medical consultation for adolescents who scored high on a self-administered questionnaire,~     and to assess the impact of this approach by later monitoring.~   "
103101|NCT01707563|"~     Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in~     the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter~     familial clinical expressivity is extremely variable. The underlying mechanisms for~     variability are not understood. An interesting mechanism is that the expression level of the~     wild type and/or mutated allele may play a role in the determination of variability.~      Principal objective: To evaluate in Marfan patients, if FBN1 expression level (non-mutated~     or mutated allele) modulates the clinical expression of the disease.~      Judgment criteria : Correlation allelic expression level-phenotype Perspectives : To search~     the predictive factors of severity in order to ameliorate precocity of taking care.~   "
103102|NCT01707550|"~     This observational survey study will capture all renal transplant patients in Serbia who are~     currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive~     protocol.~   "
103103|NCT01707537|"~     To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine~     in Healthy Adult Men~   "
116640|NCT01529307|"~     This study will assess safety, tolerability, maximum tolerated dose or recommended dose for~     expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.~   "
103104|NCT01707524|"~     The aim of this study is to measure radiation exposure during coronary angiography (CA) with~     a trans-radial approach (TRA), specifically comparing access via the left versus right~     radial artery in patients with suggested clinical predictors of TRA failure/difficult. These~     predictors include age >70, female gender, height <64 inches, and history of~     hypertension.The study also aims to determine difficulties encountered during left or right~     radial access in this specific patient population. A secondary aim is to compare the results~     of enrolled patients with a registry of patients where femoral access was obtained.~      Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the~     United States annually. There is a growing trend to perform procedures utilizing the TRA due~     to recent data demonstrating decreased bleeding and access-site complications compared to~     the femoral approach. However, the TRA approach is also know to be associated with greater~     radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization~     may be difficult in certain populations because of anatomic considerations. Though~     traditionally completed via canalization of the right radial artery (RRA) due to feasibility~     with room setup, left radial artery (LRA) access may be superior due to the shorter distance~     needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian~     artery. Given the benefits of the TRA, it is important to determine how left versus right~     radial artery access affects parameters of radiation exposure in addition to procedural~     difficulty.~      This study will be a prospective, randomized study of patients with suggested predictors of~     TRA failure/difficulty referred for coronary angiography. Patients referred for coronary~     angiography using the trans-radial approach will be randomly assigned to obtain arterial~     access via the right or left radial artery. A registry of patients referred for coronary~     angiography using the trans-femoral approach will be compiled. The primary outcome measure~     will be radiation exposure as measured by dose area product output from the coronary~     angiography system. Secondary measures will include the total fluoroscopy time, total dose~     of radiation, number of catheters used, and incidence of subclavian tortuosity. In addition,~     procedural complications and success rates will also be evaluated.~   "
103105|NCT01707511|"~     Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value~     of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between~     Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery.~     Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal~     pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference~     were also investigated.~   "
103106|NCT01707498|"~     This is multi-center prospective randomized trial evaluating the effectiveness of a new~     brain-computer interface for communication of quadriplegic patients in a clinical context.~     This performance of this will compared to traditional assistive technology (scanning system)~     and to performance of a healthy volunteer population.~   "
103107|NCT01707485|"~     This study will investigate the feasibility of testing whether a 5-day course of antibiotics~     is as effective as a 10-day course for the treatment of uncomplicated community-acquired~     pneumonia (CAP) in children. To accomplish this, previously well children aged 1-10 years~     who present to McMaster Children's Hospital (MCH) emergency department (ED) with CAP will,~     if they consent, be randomly chosen to be given either a 5 day or 10 day course of~     amoxicillin. Neither the child, the child's caregiver, nor the researchers will know whether~     the child is in the 5- or 10-day antibiotic group. Once the child has received the~     medication and for two weeks after that, caregivers of children will be asked to complete a~     daily symptom diary for their child, and will come to MCH at the end of the two week period~     (between day 14-18) to be assessed by one of the researchers. This information will then be~     used to compare both groups of children to determine if a 5 days of treatment is~     non-inferior to 10 days. The investigators hypothesize that running such a trial is~     feasible.~   "
103108|NCT01707472|"~     This is an open label, exploratory study of simtuzumab (GS-6624) in adults infected with~     HIV, hepatitis C virus (HCV), or co-HIV/HCV with histological evidence of liver fibrosis.~     Participants will receive simtuzumab 700 mg intravenously every 2 weeks for a total of 24~     weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects~     only).~   "
103109|NCT01707459|"~     This prospective, multicentre, observational study aims to test pre-operative platelet~     function when taking anti-platelet medications. The investigators are using a simple bedside~     blood test called Thromboelastography (TEG) and Platelet Mapping Assay (PMA). The~     investigators will then follow the patient throughout their hospital stay for any major~     cardiac complications (MACE) after surgery (peri-operative). The investigators hope to~     determine if there is an association between how well platelets were inhibited by these~     drugs before surgery and MACE during the perioperative period, 30 day, and one year~     follow-up. Also, the response of various people to anti-platelet medications and their~     chances of getting a major adverse cardiac outcome are determined by their genetic makeup.~     The investigators will try to determine if certain genes are associated with higher cardiac~     risk.~      Hypothesis: In patients who had percutaneous coronary intervention (PCI) and are undergoing~     non-cardiac surgery (NCS) major adverse cardiac events (MACE) are associated with inadequate~     platelet inhibition.~   "
103110|NCT01707446|"~     Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a~     serious complication that results in prolonged length of stay, increased health care costs~     and is associated with higher death rates. The exact cause involved in the development of~     delirium after cardiac surgery is unclear. The latest advancement in near-infrared~     spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain~     injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac~     surgery, recording oxygenation in real time allowing the clinical team the opportunity to~     intervene early to prevent ischemia and possibly preventing untoward events. Adverse events~     followed include, but are not limited to, stroke, (transient ischemic attacks), heart~     attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure,~     pneumonia, cause of death for 30-days after surgery (all cause mortality).~      Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in~     lower delirium rates after complex cardiac surgery.~   "
103111|NCT01707433|"~     BACKGROUND/OBJECTIVE: Quantitative urine screening for mucopolysaccharides (MPS) has been~     the primary method for detecting mucopolysaccharidoses in children. This method may not be~     sufficiently sensitive and may miss some patients with arylsulfatase B (ARSB) deficiency.~     Investigators propose to identify patients retrospectively and prospectively who carry a~     diagnosis of spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral proximal~     femoral epiphyseal dysplasia, or bilateral Legg-Calve-Perthes. For these patients,~     investigators will perform enzyme testing on a blood sample which will identify MPS VI or~     IVA.~      Patients who have an earlier diagnosis of MPS are likely to have better health outcomes with~     medical management. Therefore, it is important to determine effective diagnostic methods.~     Investigators believe that bilateral hip involvement should alert the clinician to the~     possibility of MPS VI and further examination. The purpose of this study is to test the~     hypothesis that the correct diagnoses of two MPS storage disorders are delayed in patients~     with bilateral proximal femoral epiphyseal dysplasia and normal quantitative urine MPS~     studies.~   "
103112|NCT01707420|"~     The typical post-operative course for children following surgical removal of their tonsils~     and adenoids can be challenging, especially for pain control. First line medications for~     pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal~     anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their~     effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down~     the body's response to pain and decreases opioid use post-operatively. The purpose of this~     study is to see if a single preoperative dose will reduce post-operative pain scores and the~     amount of analgesic used.~   "
103113|NCT01707407|"~     1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp~          inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects.~        2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor~          ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in~          healthy male subjects.~        3. To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and~          the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp~          inhibitor ketoconazole in healthy male subjects.~      Part 2~      1) To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer~     carbamazepine compared with pomalidomide alone in healthy male volunteers.~      Secondary Objectives~      1) To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with~     ketoconazole, fluvoxamine and/or carbamazepine.~      In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered~     with ketoconazole, fluvoxamine and/or carbamazepine.~   "
103114|NCT01707394|"~     CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this~     study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for~     thrombosis~   "
103115|NCT01707381|"~     This clinical investigation is being performed to compare the effect of BOL-303259-X dosed~     once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular~     pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or~     ocular hypertension (OHT).~   "
103116|NCT01707368|"~     The purpose of this observational study is to document the course of disease and relapse~     management during treatment with Daivobet® Gel under consideration of patient`s individual~     application habits under daily use conditions.~   "
103117|NCT01707355|"~     The poster is effective in improving the level of knowledge regarding dental trauma of~     primary and secondary schools teachers in Hong Kong.~      A cluster randomized controlled trial was conducted in mid May 2011,to test the level of~     knowledge regarding dental trauma with two groups, the intervention group with posters and~     control group without posters. A questionnaire is used to test the level of knowledge.~   "
103118|NCT01707342|"~     The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics~     (what the body does to the medication) of simeprevir (TMC435) after administration of single~     oral doses of 50 mg and 150 mg when administered together with a single intravenous (IV)~     dose of 100 microgram [3H]-TMC435 in healthy male participants.~   "
103119|NCT01707329|"~     This phase II randomised, double blind, placebo controlled, multicentre trial is designed to~     assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy~     alone in patients who have progressed after benefiting from previous second or third-line~     icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell~     lung cancer.~   "
103120|NCT01707316|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754~     (canagliflozin) and its main metabolites (break-down products) following 2 different doses~     of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin~     will also be assessed.~   "
103121|NCT01707303|"~     This is a randomized, controlled, pilot study of two separate Cohorts of patients from the~     intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical~     therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50~     patients and randomize to receive either two physical therapy sessions per day or usual~     care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be~     mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength~     assessments and the short physical performance battery (SPPB). Study subjects will have~     blood for cytokine analysis through their first week of study.~   "
103122|NCT01707290|"~     The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in~     subjects with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and~     113 (NCT01685801).~   "
103123|NCT01707277|"~     Previous studies have evaluated the effects of inspiratory muscle training in patiens with~     heart failure and reduced ejection fraction; nevertheless,no evidence endorse the~     therapeutic role of inspiratory muscle training in patients with heart failure and preserved~     ejection fraction. The investigators sought to evaluate whether 12-week inspiratory muscle~     training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test),~     as well as left ventricular diastolic function, serum biomarkers and quality of life~     (Minnesota Living With Heart Failure Questionnaire) in patients with heart failure with~     preserved ejection fraction and non-reduced inspiratory muscle strength.~   "
103124|NCT01707264|"~     Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30~     subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and~     pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.~   "
103125|NCT01707251|"~     Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours~     morphine requirement using IV PCA in patients after laparoscopic bariatric surgery.~     Secondary objective is to determine if it decreases respiratory depression measured using~     RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and~     pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare~     incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary~     retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity~     in ibuprofen and control groups.~   "
103126|NCT01707238|"~     The purpose of this study is to compare the subjective performance for handling of two daily~     disposable contact lenses, stenfilcon A and etafilcon A.~   "
103127|NCT01707225|"~     The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI~     bleeding in patients with a left ventricular assist device (LVAD). Patients undergoing~     implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of~     gastrointestinal bleeding. This is a significantly associated morbidity and can threaten a~     patient's life as well as their ability to undergo eventual heart transplantation secondary~     to both general health/strength and the potential development of antibodies to blood~     products that would make future transfusions and transplantations more difficult.~      If this research finds that use of octreotide LAR can decrease the incidence of~     gastrointestinal bleeding in this patient population, it will revolutionize the manner in~     which these patients are managed. The finding of reduced GI bleeding would allow the patient~     to have less exposure to blood products, reduce hospitalizations, and ensure that subsequent~     transplant planning not be delayed. This would not only be of great benefit to the patient,~     but would significantly decrease health-care costs through preventive measures.~      The goal of this project is to study whether the regular administration of monthly~     octreotide LAR is safe and if it will decrease the incidence of gastrointestinal bleeding in~     patients undergoing implantation of non-pulsatile, continuous flow left ventricular assist~     devices (LVAD).~   "
103128|NCT01707212|"~     There are numerous pain management strategies available for the management of infant~     immunization pain. The majority of infants, however do not benefit from these interventions,~     which causes them to suffer pain unnecessarily. This study will assess the impact of~     educating parents about pain management strategies on their knowledge and behaviour~     regarding pain management during routine 2-month infant immunization injections.~   "
103129|NCT01707199|"~     In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium~     falciparum resistance to chloroquine. In 2003 the high failure rate of chloroquine against~     falciparum malaria led the national malaria treatment programme to switch its recommended~     first line drug treatment for uncomplicated Plasmodium falciparum malaria to~     artemisinin-based combination therapy (ACT) in the form of~     Artesunate/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7~     days).~      For operational reasons, prior to recent studies (manuscript in preparation) there have been~     no molecular data on P. falciparum SP resistance markers from within the borders of~     Afghanistan. These studies have revealed early evidence of increasing SP resistance~     (resistance polymorphisms with double DHFR & triple DHPS mutations). The aim of this study~     is to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the~     AS+SP combination in this province, along with molecular studies of isolates from recruited~     patients.~   "
103130|NCT01707186|"~     PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the~     mid-1990s; the task was first developed as a simple measure of how a person was coping with~     his or her experience of illness. This is an international, multicentre study to evaluate~     the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages~     of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford,~     Limoges, Montreal and Queensland. The study will recruit 200 patients in total.~      In addition to the procedures for the patient's routine clinical visit, the patients will be~     invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be~     asked to attend 3 times over 24 weeks~   "
103131|NCT01707173|"~     This is a research study of African American parents/caregivers of newborns. The purpose of~     this research study is to learn what type of educational materials about infant safety and~     safe infant sleep are most effective and acceptable to parents and caregivers. The~     investigators will compare the responses of parents who receive enhanced materials to the~     responses of parents who receive the ordinary materials that are currently in use.~   "
103132|NCT01707160|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin~     30/70 PreMix in healthy volunteers.~   "
103133|NCT01707147|"~     The aim of this study is to monitor safety and efficacy of treatment with linagliptin in~     Korean patients with type 2 diabetes mellitus in routine clinical settings.~   "
103134|NCT01707134|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile~     of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.~   "
103135|NCT01707121|"~     Over the last decades different life style factors have been established as risk factors for~     various diseases. The obesity pandemic displays a good example of a disease where great~     effort is undertaken to characterize risk factors associated with obesity (1). Smoking is~     another life style risk factor established since several decades, and where primary~     prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at~     the University of Gothenburg recognized PA as a factor of importance early on and thus~     included PA related questions in the work up of studies with large cohorts (4-6). A 4-level~     scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used~     extensively since then. With this background it is of interest to record physical activity~     one year and one month prior to certain types of elective surgery and to study the~     relationship of PA to surgical complications and recovery is of interest.~      The aim of this study is to investigate whether a higher physical activity prior to a~     surgical procedure reduces hospital stay, sick leave and the complication rate.~      A secondary aim is to investigate the effect of preoperative physical activity on the rate~     of resumption of QoL and normal physical function.~   "
103136|NCT01707108|"~     The aim of the present study is to evaluate the 1-year and 3-year survival and success of~     MIS® C1 implants with a length of 10-15mm.~      Specific Aims~        1. To study 1-year and 3-year implant survival rate C1 implants~        2. To study 1-year and 3-year implant bone level changes of C1 implants~   "
103162|NCT01706770|"~     The primary objective of thes study is to confirm that the ocular response to the Test~     lenses are similar to those of the Control lenses when used in a 1 week planned replacement,~     daily wear modality over a 1-month period.~   "
103175|NCT01706601|"~     Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population.~     This means that many patients are referred to surgical specialist reception with diagnosis~     hemorrhoidal disease. The aim of this study is to describe population of patients with~     hemorrhoidal disease that are referred to a specialised colorectal unit and to determine~     what treatment they are given at a general practitioner as well as in colorectal unit.~   "
103137|NCT01707095|"~     Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive~     coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent~     to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to~     the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653]~     In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar~     site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic~     cholecystectomy. Our benchtop research compared bundling of the camera cord with the active~     electrode cord versus unbundling of the camera cord with the active electrode cord and found~     a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL,~     Robinson, TN, et al. Surg Endosc (2012) Epub.]~      This study plans to compare thermal injury which occurs during two commonly used operating~     room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode~     cords. And second, laparoscopic cholecystectomy with unbundled camera/active electrode~     cords. The primary outcome is the incidence of thermal injury at the skin adjacent to the~     camera port site (the umbilical port) that will be diagnosed by histology.~   "
103138|NCT01707082|"~     Part A of the study will test the safety, the amount of drug in the body, and effects of the~     drug in the body after multiple doses. This will be conducted in healthy overweight adults.~     Part B of the study will test the effects of multiple doses of the investigational drug on~     the amount of midazolam, an approved drug, in healthy adults.~   "
103139|NCT01707069|"~     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is~     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is~     tolerated and how research participants respond to the vaccine in various doses.~     CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not approved for use by~     the United States Food and Drug Administration (FDA) but is available in research studies~     like this one. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to~     humans.~      The purpose of this study is to evaluate the safety of an investigational vaccine intended~     to treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the~     material that cells use to provide instructions to make proteins. The DNA carries the~     information necessary to make a special protein which is a combination of a protein found in~     all cells, LAMP (lysosomal associated membrane protein), and the protein from Japanese red~     cedar that causes the allergy known as Cry J2. This vaccine is intended to help re-educate~     the immune system with respect to how it will respond to naturally occurring red cedar~     allergen and eliminate the allergic symptoms. Another purpose of this study will be to~     document the immune response to the vaccine~      Subjects that are eligible to participate in this study will be assigned by whether they are~     sensitive or non sensitive to CryJ2 or Mountain Cedar and chance (like flipping a coin) to~     one of 3 study vaccine groups:~      Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive~     four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram~     doses of the study vaccine.~      The study vaccine is administered as an intramuscular injection. Enrolled subjects will~     receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their~     study vaccine assignment. Participants who are not allergic to Japanese red cedar will be~     assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain~     Cedar will have an equal chance of being assigned to Group 2 or 3.~      There will be between 18 to 30 men and women participating in the study at one location.~     Your participation in this study will last approximately 72 days.~   "
103140|NCT01707056|"~     The purpose of this study is to evaluate whether taking thyroid hormone medication with~     beverages other than water, decreases absorption of the medication by the intestine.~     Specifically we are interested in whether coffee, coffee with milk, or black tea affects how~     thyroid medication is absorbed by the body. Previous studies have suggested that taking~     thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given~     that many patients take their thyroid medicine with beverages other than water, and~     specifically with coffee or tea, understanding whether and how much coffee or tea may~     decrease thyroid hormone absorption is important for clinical practice.~      This study will help determine the safest and most effective way for adults to take their~     thyroid medication and will guide medical practitioners in how to counsel their patients~     when they prescribe thyroid hormone.~   "
103141|NCT01707043|"~     This is an open label, investigator-blinded, cross over, prospective, single center study of~     subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone~     dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone~     dipropionate 0.064%) Topical Suspension will each be applied topically once daily.~      The primary objective is to assess the patient preference for Taclonex® (calcipotriene~     0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp®~     (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the~     treatment of plaque psoriasis.~      The secondary objective is to assess the efficacy for Taclonex® (calcipotriene 0.005% and~     betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene~     0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque~     psoriasis.~   "
103142|NCT01707030|"~     Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous~     for them than it is for a non-infected person. In this VA study, such individuals will be~     screened and given feedback on their drinking using an Internet-based program which has been~     shown to reduce drinking in other populations. The research team will evaluate whether the~     program helps Veterans drink less over time and thereby improve their health.~   "
103143|NCT01707017|"~     The purpose of this study is to compare the impact of high- and low-intensity resistance~     exercise on force-velocity characteristics, muscle mass and inflammatory processes in older~     adults. As all training protocols are designed to end with maximal effort, effects are~     expected to be similar between groups.~   "
103144|NCT01707004|"~     This phase II trial studies how well decitabine and total-body irradiation followed by donor~     bone marrow transplant and cyclophosphamide works in treating patients with relapsed or~     refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a~     donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving decitabine~     and total-body irradiation before the transplant together with high-dose cyclophosphamide,~     tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.~   "
103145|NCT01706991|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus. All tests and observations will be done at a single~     visit over the course of approximately 30 minutes.~   "
103174|NCT01706614|"~     Investigation of biochemical and genetic markers in liver disease that might have an~     influence on the course of the disease~   "
103176|NCT01706588|"~     This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in~     approximately 75 patients undergoing surgical removal of an impacted lower third molar.~   "
103146|NCT01706978|"~     This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff~     repair; soft tissue and bone trephination. Trephination is a procedure that involves~     making small perforations either in the torn tendon near its edge, or in the bone that the~     tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in~     the shoulder. Trephination is a new technique that is used in addition to the standard~     method of repairing the rotator cuff tendon.~      This study will help to determine whether this technique improves the speed of healing, the~     strength and the re-tear rate of the repair. You are being asked to take part in this study~     because you have a tear of the rotator cuff that requires surgical treatment. A total of 90~     participants will participate in this study.~   "
103147|NCT01706965|"~     Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with~     schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical~     response to Kuvan treatment including negative symptom and cognitive deficits, evaluate~     safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of~     changes in plasma Kuvan levels and efficacy outcomes.~   "
103148|NCT01706952|"~     The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4%~     versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.~   "
103149|NCT01706939|"~     This trial aims to directly compare a reduced radiation dose to the standard of care in~     HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two~     groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are~     non-inferior to standard dose CRT.~   "
103150|NCT01706926|"~     The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of~     mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with~     moderate-to-severe adult onset Rheumatoid Arthritis (RA).~   "
103151|NCT01706913|"~     This is a randomized, controlled study to compare patients evaluated and managed by internal~     medicine hospitalists alone versus patients who are additionally evaluated by a~     dermatologist when they are admitted to the hospital, aiming to demonstrate that hospital~     admissions for cellulitis that involve early dermatology consultation will reduce hospital~     length of stay, readmission rates, prevalence of pseudocellulitis, cost, and antibiotic~     usage. The hypothesis of this study is that obtaining inpatient dermatology consultations,~     within 24 hours of a patient being admitted to the hospital for cellulitis, will reduce the~     length of stay, readmission rate, cost, and antibiotic usage of the patient‟s admission as~     well as properly evaluate and diagnose patients with pseudocellulitis. The primary objective~     will be to measure the difference in the length of stay for patients who are randomized to a~     dermatology consultation within 24 hours of hospital admission (active arm) versus being~     managed by an internal medicine hospitalist alone, as is the standard of care (control arm).~     The length of stay for each arm will be assessed once the study has been completed. The~     secondary endpoint will be to measure readmission rates for cellulitis after patients are~     discharged from the hospital. An additional endpoint will be to determine if antibiotic~     usage differs between patients randomized to a dermatology consultation and those not.~     Exploratory analyses will assess the percentage of patients with a concomitant known~     predisposing factor for recurrent cellulitis such as lymphedema, leg ulceration, tinea~     pedis, or onychomycosis, as well as the association of fever >100.5 F and a history of a~     prior episode of cellulitis.~   "
103152|NCT01706900|"~     Incubator temperature is one of the most precious variables in IVF labs. When the IVF~     started, almost all incubator temperatures were set at 37 degrees which mimic in vivo~     conditions. Some authors speculated that gametes and early embryos might need low~     temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37~     degree or slightly lower 36.5 degree and extensively investigate to find which is better to~     crucially introduce a solid evidence through this RCT.~   "
103153|NCT01706887|"~     Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt~     retention by the kidney. The study address the consequence of a frequent genetic variation~     leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to~     excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute~     a genetic predisposition to (or protection against) salt-sensitive hypertension.~   "
103154|NCT01706874|"~     The purpose of this study is to assess the impact of an intervention (scaled every 06 months~     associated with the use of mouthwash with essential oils (toothpaste and Listerine® 2 times~     / day containing polymer Triclosan (Colgate Total®)) on the activity of rheumatoid arthritis~   "
103155|NCT01706861|"~     The objective of the study is to actively gather additional information on safety, device~     performance and possible emergent risks following the use of Celotres in a post-market~     setting when used to reduce the recurrence rate, volume, appearance and/or symptoms~     associated with keloid scarring in subjects undergoing surgical excision of keloids as~     compared to the scientific literature.~   "
103156|NCT01706848|"~     The objective of the study is to actively gather additional information on safety, device~     performance and possible emergent risks following the use of Celotres in a post-market~     setting when used to improve wound healing and the resulting scar consequences following~     suturing of a wound.~   "
103157|NCT01706835|"~     This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin~     administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with~     advanced solid tumors.~   "
103158|NCT01706822|"~     To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or~     anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary~     endpoints.~   "
103159|NCT01706809|"~     The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF~     and others ability to predict time to recidive and progressions free survival.~   "
103160|NCT01706796|"~     The primary purpose of this study is to estimate the relative bioavailability and food~     effect of PF-06273340 tablets.~   "
103161|NCT01706783|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, availability and distribution in the body of once-weekly long-acting growth~     hormone (NNC0195-0092) compared to once daily Norditropin NordiFlex® in adults with growth~     hormone deficiency (GHD).~   "
116641|NCT01529294|"~     This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone~     in subjects with mild or moderate hepatic impairment comparatively to healthy matched~     subjects~   "
103163|NCT01706757|"~     The ability to walk is one of the fundamental attributes of human beings. However, with~     advancing age this ability is modified by a combination of physiological and pathological~     aging.These changes mainly involve an irregularity of the pitch, reducing the length of the~     stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti,~     Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that~     20-30% of heathly older fall each year and state that one of these falls, 25% result in~     injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear~     of falling exists in many older people even before a drop in effective (Recommandation of~     HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year~     with a fall and this association increases rapidly with advancing age in both sexes. It is~     therefore important in terms of public health, learn to recognize the gait disturbance, to~     prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess~     the risk of falling. Some are comprehensive but time-consuming and are generally discarded~     in favour of other simpler tests (test of Tinetti or get up and go test). However, the~     listing of these lacks precision, particularly in terms of duration single timer.To overcome~     these biases, innovative technology solutions seem to be a good way. In this study, the~     investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted~     Navigation Guide), to obtain more reliable and accurate measurements of parameters such as~     walking speed and direction. Thus, the investigators set the main objective, to compare a~     standard evaluation of the process to a technology assessment, in participants aged 65 to 86~     years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the~     elderly, develop an index of walking and test the feasibility of detecting a weakness of the~     knee joint by ANG undetected at clinic.~   "
103164|NCT01706744|"~     The main goal is to investigate the following topics:~        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge~          to Verdal Municipality, be equally effective in preventing aggravation of disease and~          loss of function for patients over 60 years that have been hospitalized in Levanger~          hospital?~        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital~          is not located in the same Municipality, comparable to the cost by direct discharge to~          the Municipality of Verdal, for patients over 60 years that have been hospitalized in~          Levanger hospital?~        3. Which issues are considered important by patients and health personnel during~          discharge, arrival and follow up in the Municipality, to ensure an optimal interaction~          between the involved units.~   "
103165|NCT01706731|"~     This research is to study the effectiveness of cognitive behavioral therapy-CBT and~     Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive~     and Buddhist concepts are related. This randomized controlled trial is to study the elderly~     participants who suffer major depressive disorder according to DSM-IV. The subjects will be~     divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per~     week for 6 weeks in addition to usual treatment. The control group will receive treatment as~     usual and general conversation (non-CBT) with monks. Pretreatment factors (such as~     attachment style, interpersonal factors) of both therapist monks and patient participants~     will be studied.~   "
103166|NCT01706718|"~     Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and~     could therefore be an important dietary component in the management of hypertension and~     cardiovascular disease, however consumption is relatively low. We evaluated the effects of~     beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and~     blood pressure response in healthy men.~   "
103167|NCT01706705|"~     The goal of this clinical research study is to learn if computed tomography (CT) and~     magnetic resonance imaging (MRI) images can better help to plan internal radiation~     treatment.~   "
103168|NCT01706692|"~     The purpose of this study is to evaluate the long-term course of patients with psoriasis and~     psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric~     acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A~     patient will be included at first initiation of the treatment and will remain in the~     registry for 5 years, regardless of subsequent therapy.~      The registry will also evaluate safety clinical outcomes and health related quality of life.~   "
103169|NCT01706679|"~     To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101~     treatment on Fridericia's corrected QT interval (QTcF).~   "
103170|NCT01706666|"~     This randomized phase II trial studies how well giving bortezomib with or without~     combination chemotherapy works as consolidation therapy in patients with newly diagnosed~     multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them~     from dividing. It is not yet known whether giving bortezomib is more effective with or~     without combination chemotherapy in the post transplant setting.~   "
103171|NCT01706653|"~     The purpose of this study is to determine whether consumption of the active product affects~     postprandial changes in metabolic indices, in comparison to the control product.~   "
103172|NCT01706640|"~     This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage,~     Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re-~     Operative procedures.~      Objective of this study is to assess current practice pattern and best practice sharing of~     usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous~     reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence,~     severity and extent of post surgical adhesion enforcement of suture lines in lung resection~     procedures (3) From this data to document and generate a real life experience on the use of~     Coseal in cardio vascular and thoracic surgery.~      Number of expected patient enrollment is 750 from 20 participating sites.~   "
103173|NCT01706627|"~     Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for~     reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo~     controlled trials have been conducted. This study evaluates the effect of melatonin in~     improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer~     patients. This is a multi-center, randomized, double-blind, placebo controlled trial~     conducted in patients with histologically proven advanced non small cell lung, breast, head~     and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment~     scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or~     matched placebo. The patients are required to take the studied drugs at night (after 21.00~     pm) on the first day of chemotherapy and continue daily for six months. Standard treatment~     is chemotherapy according to each center's standard protocol. Study endpoints are QOL~     (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and~     survival.~   "
103177|NCT01706575|"~     This open-label, single-arm, multicenter study will evaluate the efficacy and safety of~     adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in~     participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA~     suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg~     decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg~     subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will~     be a further 48 weeks, during which the participants will continue their NA treatment.~   "
103178|NCT01706562|"~     The purpose of this study is to investigate the overall success rate of itraconazole~     intravenous treatment for a period of more than 7 days.~   "
103179|NCT01706549|"~     Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical~     examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The~     aims of the study are:~        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons~          for the pain.~        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.~        3. to reveal the impact of pain on quality of life.~   "
103180|NCT01706536|"~     This is a randomized, double-blind, placebo-controlled, parallel arm study. The study~     population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to~     severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.~   "
103181|NCT01706523|"~     This is an open-label extension protocol that will provide necessary data on the safety,~     tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.~   "
103182|NCT01706510|"~     Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients~     with stable coronary artery disease.~   "
103183|NCT01706497|"~     The postoperative period after congenital heart surgery in children can be a very critical~     episode, where it is of utmost importance to closely monitor the circulation in these~     patients. Invasive hemodynamic monitoring tools available in the adult population, are often~     not suitable to use in small children.~      The Fore-Sight(TM) is a non-invasive monitor for brain tissue oxygenation (SctO2), by~     projecting harmless near-infrared light trough the skin, skull, and brain via a disposable~     sensor that is applied on the forehead of patients. In many centres, the Fore-Sight (TM) is~     part of the routine monitoring of children during cardio-pulmonary bypass for congenital~     heart surgery. Although the monitor has not been tested for this purpose, it is often~     continued in the postoperative phase in the intensive care unit (ICU), where it is used to~     monitor the hemodynamic situation of the patient.~      The purpose of the present study is to examine and validate the use of the Fore-Sight~     monitor for hemodynamic monitoring of children in the postoperative phase after cardiac~     surgery.~      The study hypothesis is whether SctO2 desaturations are predictive for future hemodynamic~     deterioration of the patient, and whether these SctO2 desaturations are predictive for the~     outcome of these patients.~   "
103184|NCT01706484|"~     The purpose of this trial is to determine whether 2 different dosages of a herbal extract~     (240 and 480 mg/day) are more effective than placebo in the treatment of patients with~     chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5~     and Visit 6.~   "
103185|NCT01706471|"~     Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft~     survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute~     rejection episodes of cadaveric allograft recipients. Although marked progression has been~     made in initial survival rates, long-term kidney graft survival has yet to show such~     encouraging results. Because CNIs are associated with adverse effects, particularly~     nephrotoxicity, which contribute to declining organ function and eventual graft loss. In~     kidney transplants, progressive allograft dysfunction has been shown to develop in as many~     as 94% of patients by 1 year.~      Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be~     balanced against the maintenance of adequate immunosuppression.~      Certican allows CNI dose reduction then provides renal function improvement and current PSI~     strategy point out that early intervention is important in managing the risk of CAN before~     it develops in both de novo and maintenance renal transplant recipients.~      To demonstrate Certican early introduction after 1 month provides better renal function with~     no change of efficacy compared to standard regimen, and also prevent delayed wound healing.~   "
103186|NCT01706458|"~     This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic~     acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded~     to previous treatment with hormones and has spread to other places in the body. Vaccines may~     help the body build an effective immune response to kill tumor cells. It is not yet known~     whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in~     treating prostate cancer.~   "
103187|NCT01706445|"~     To study the effects of an 8-week combined inspiratory muscle training and exercise~     (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal~     inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)~     (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in~     children with Cystic Fibrosis (CF) (secondary outcomes).~   "
103188|NCT01706432|"~     This pilot clinical trial studies hypofractionated image guided radiation therapy in~     treating patients with stage IV breast cancer. Radiation therapy uses high energy x rays to~     kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells~   "
103197|NCT01706315|"~     This will be a randomized, placebo-controlled, single blind study to investigate the safety,~     tolerability and pharmacokinetic (PK) profile of GSK2140944 following repeat oral doses in~     healthy adult subjects. The study will include a Screening period (40 days), Treatment~     period (16 days) and a Follow-up period (26 to 30 days). A single dose will be administered~     on Day 1 for characterization of single dose PK, followed by twice-daily (BID) or~     thrice-daily (TID) dosing on Days 3 to 16. Subjects may only be randomized to one cohort per~     the randomization schedule. Up to 6 cohorts will be enrolled using a sequential panel.~     Subjects in Cohort 1 will receive GSK2140944 (6) and placebo (2). Subsequent cohorts will~     enroll 16 subjects such that 12 subjects will receive GSK2140944 and 4 subjects will receive~     placebo, per dose level according to the randomization schedule. Dose escalations are~     planned to run in successive weeks. Cohort 2 may begin dosing once subjects in Cohort 1 have~     completed 7 days of BID dosing, PK data is reviewed and safety data from at least 6 subjects~     is available. Each subsequent dose escalation will commence only when GSK2140944 safety data~     and available PK data of at least 12 subjects dosed at the previous dose level have been~     reviewed. The number of cohorts may be reduced or expanded if needed. The first planned dose~     is 400 milligram (mg) BID but may be modified based upon emergent PK, safety and~     tolerability data from ongoing clinical study BTZ115198 evaluating single and repeat~     intravenous (IV) doses of GSK2140944. The projected dose for Cohort 2 is 800 mg BID, Cohort~     3 is 1500 mg BID, Cohort 4 is 2300 mg BID or 1500 mg TID and Cohort 5 and cohort 6 will be~     decided later. The planned maximum dose is 2500 mg TID but may be modified based upon~     emergent safety, tolerability and PK data. Doses of GSK2140944 or placebo will be~     administered following a moderate fat meal.~   "
103189|NCT01706419|"~     Rice fortification has been shown to be safe and effective in improving micronutrient status~     in many studies around the world. However, most studies have been done in Latin America,~     Africa and India. There are no studies available from Cambodia. Moreover, there is no data~     available on whether fortified rice can reduce the prevalence of anemia in school children~     in Cambodia, nor whether there will be additional benefits, such as better learning~     capability of school children or fewer days missed due to better health. To inform WFP,~     Cambodian policy and the public on the potential benefits of fortified rice on health and~     development for Cambodian school children, an intervention study will be conducted in~     Kampung Speu province during the 2012 - 2013 school year. The study will be conducted by~     IRD, PATH and WFP. Sixteen schools will be selected to receive either the normal rice~     provided by the WFP school meal program, or fortified rice instead of normal rice. Three (3)~     different types of fortified rice will be tested, to identify the best type of fortified~     rice. In addition, 4 schools with no school meal program will be selected to serve as~     control. School attendance and morbidity will be followed in all children in the~     participating schools over the whole school year. Biochemical indicators of micronutrient~     status will be determined in a subgroup of children (25% of the children), which requires~     collection of blood, urine and stool samples.~   "
103190|NCT01706406|"~     The purpose of this study is to pilot test and determine the efficacy of a psychoeducational~     intervention (PED) we recently piloted in a group format for women with acquired sexual~     arousal disorder (FSAD).~      HYPOTHESES:~        1. - Compared to baseline measures, the PED will result in significant improvement in~          self-report measures of: (a) subjective sexual arousal; (b) perception of genital~          arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual~          distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of~          life.~        2. - It is unknown what effect the PED will have on actual physiological sexual arousal.~        3. - The group format will be a feasible and cost-effective method of delivering~          empirically supported treatment to women with sexual arousal difficulties and will~          contribute towards meeting the needs for sexual health care for women on the clinic~          wait-list at the BC Centre for Sexual Medicine.~   "
103191|NCT01706393|"~     The purpose of this study is to evaluate the effect of probiotics to improve the intestinal~     microbiome in malignancy patients who get pelvic/abdominal radiotherapy.~   "
103192|NCT01706380|"~     The present study, in an out-patient setting for substance use treatment in adolescents,~     examines the effect on treatment retention of a mobile telephone follow-up technique~     (interactive voice response), with or without personal feedback. Subjects in treatment for~     substance use disorders will be followed by automated mobile telephone contact with~     questions about psychiatric symptoms and substance use, and the investigators hypothesize~     that this technique, including a personal feedback reporting back to the client whether his~     or her status is changing in one way or another, may increase the treatment retention,~     possibly by means of an intensified treatment contact.~   "
103193|NCT01706367|"~     This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three~     dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85~     years. The main goal of the study is to determine how safe and well-tolerated the vaccine~     is. In addition, the study aims to assess the immune response to the C difficile vaccine.~   "
103194|NCT01706354|"~     End stage renal failure (ESRF)describes an irreversible loss in renal function. The majority~     of these patients will opt for haemodialysis (HD)as their chosen method of renal replacement~     therapy (RRT). Arteriovenous fistulae (AVF) are the optimal method of achieving vascular~     access to permit HD. AVF are created with a small surgical procdure to join the artery and~     vein together. Over the next 6- 8weeks after surgery the AVF should grow (mature) into a~     vessel suitable for needles to be inserted for dialysis. Unfortunately however, around 24% -~     35% of AVF fail at an early stage. Some anaesthetic techniques can influence intraoperative~     blood flow and venous diameter, factors which are associated with fistula success. There~     remains no conclusive evidence that any particular anaesthetic technique can significantly~     influence long term surgical outcome. This study aims to investigate whether a regional,~     compared to local, anaesthetic technique can affect fistula patency.~   "
103195|NCT01706341|"~     The purpose of this study is to investigate the effect of administering a small dose of~     glucose on the pregnant women and their neonates during cesarean section. We investigate the~     safety and efficacy of use of a glucose-containing solution for the pregnant women and the~     neonates.~   "
103196|NCT01706328|"~     This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week~     parallel group study evaluating the effects of once daily in the morning treatment of FF/VI~     Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on~     lung function in COPD subjects.~      Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to~     evaluate the subject's adherence with study treatment, study procedures and assessment of~     disease stability.~      At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the~     Randomization Criteria will be randomized to double-blind study medication (12-week~     treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or~     Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be~     available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will~     take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each~     evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded~     study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will~     return to the clinic at the end of the treatment period.~      A follow-up phone contact will be performed approximately 7 days after the last clinic~     visit. The overall study duration (Screening to Follow-up) for each subject is approximately~     15 weeks.~   "
103198|NCT01706302|"~     The study will assess the burden of RSV-attributable general practice consultations,~     hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.~   "
103199|NCT01706289|"~     Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in~     subjects with type 2 diabetes mellitus~   "
103200|NCT01706276|"~     Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin~     concentrations through compared with laboratory measurement during major hepatic surgery,~     and to determine the source of discordance between two methods.~   "
103201|NCT01706263|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever~     the reason, poor compliance translates to decreased efficacy and increased frustration on~     the part of the user.~      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the~     counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.~   "
103202|NCT01706250|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever~     the reason, poor compliance translates to decreased efficacy and increased frustration on~     the part of the user.~      The current study will evaluate and compare the efficacy and tolerability of 2~     over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne:~     MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner~     Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and~     Revitalizing Toner.~   "
103203|NCT01706237|"~     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic~     LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed~     of visual recovery results indicate that the visual recovery in the first 4 hours after the~     LASIK procedure show the most variability. A patient's ability to drive after their LASIK~     procedure would potentially alleviate a challenge that patients often face in taking~     additional time off work or simply finding a ride to there LASIK procedure.~   "
103204|NCT01706224|"~     This study aims to determine the sero-prevalence of anti-pertussis antibodies among~     healthcare professionals at hospital centres in Spain.~   "
103205|NCT01706211|"~     At least 30% of patients initially treated with sulphonylureas for NIDOM will have a poor~     response, and in the remaining 70% the subsequent failure rate is approximately 4% to 5% per~     year. BRL 49653C has a different mechanism of action to the sulphonylureas, and therefore~     the effects on fasting plasma glucose and Hb A1c are expected to be additive. Since~     circulatory insulin levels should decrease, and plasma glucose should be regulated, these~     combinations are also anticipated to slow both the progression of diabetic complications and~     delay the need for exogenous insulin.~      The proposed study is intended primarily to determine the effectiveness of BRL 49653C by~     measure of glucose homeostasis as determined by Hb A1c and fasting plasma glucose, when~     added to sulphonylurea therapy (sulphonylureas are limited to: glibenclamide, glipazide and~     gliclazide). In addition, the clinical safety of BRL 49653C will be assessed in this patient~     population. The starting doses have been selected based on dose response studies examining~     safety, tolerability and efficacy in the U.S.A.~   "
103206|NCT01706198|"~     This study is designed to compare the effectiveness and safety of Fluticasone~     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg~     Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol~     ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with~     the existing asthma maintenance therapy over twelve months in subjects diagnosed with~     asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the~     eligibility criteria are randomised and will enter a 12 month treatment period.~   "
103207|NCT01706185|"~     This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1,~     LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically~     demonstrated bladder cancer.~   "
103208|NCT01706172|"~     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be~     quite long lasting and debilitating. Dextrose injection with a small needle has been notably~     helpful in preliminary studies in reducing pain and improving jaw function. This randomized~     trial will compare dextrose injection with sterile water injection for~     temporomandibular(jaw) dysfunction, also known as TMD.~   "
103209|NCT01706159|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of~     recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active~     ulcerative colitis (UC).~   "
103210|NCT01706146|"~     Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects~     an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,~     and premature death. For those with AF and other stroke risk factors, chronic~     anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if~     the AF is infrequent or short-lived. This standard of care is based partly on our inability~     to rapidly recognize and respond to AF recurrences which can often be brief and~     asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even~     during prolonged periods of sinus rhythm where the risk of stroke is presumably low.~      Recent advances in device technology and drug therapy, however, have the potential to change~     the way the investigators manage AF. The use of a small leadless subcutaneous implantable~     cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)~     provides the ability to remotely and continuously evaluate a patient for AF recurrences,~     even episodes that are brief and asymptomatic. In addition, release of unique oral thrombin~     inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])~     allows for rapid onset anticoagulation within minutes to hours of a single oral dose.~     Together, these advances allow for continuous AF monitoring with targeted anticoagulation~     only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage~     while still protecting against stroke.~      The aim of this pilot study is to assess the feasibility of intermittent anticoagulation~     with a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable~     cardiac monitor (Reveal XT) with remote data transmission capabilities.~   "
103211|NCT01706133|"~     -Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative~     impacts on the health of elderly over 70 years ?~   "
104148|NCT01693861|"~     Observational, non randomized study aimed at measuring the effect of chemotherapy in the~     urinary concentrations of physiological modified nucleosides in 30 patients with metastatic~     colorectal cancer.~   "
103212|NCT01706120|"~     The addition of bevacizumab to first-line chemotherapy has been shown to improve progression~     free survival for patients with ovarian cancer. The purpose of this study is to explore the~     potential role of clinical and biologic factors in identifying those patients who benefit~     most from this combined therapy in terms of progression free and overall survival.~   "
103213|NCT01706107|"~     The primary objective of the study is to evaluate the impact of early treatment with Tysabri~     in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL)~     as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary~     objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS~     participants over 2 years on the following: annualized relapse rate (ARR), Expanded~     Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol~     5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual~     analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2~     years.~   "
103214|NCT01706094|"~     A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute~     ischemic stroke could be to place the patient in a 'lying flat' rather than upright head~     position. Given uncertainty over the balance of potential modest benefits and risks, and~     variability regarding the ideal head position policy for patients with acute ischemic stroke~     around the world, reliable randomized evidence is required to standardize clinical practice.~      The main objectives of this pilot phase clinical trial are to determine the feasibility,~     safety and potential efficacy of a large-scale cluster randomized clinical trial to assess~     whether a simple nursing care policy - 'lying flat head position' - provides beneficial~     effects as compared to the standard upright head position in patients with acute ischemic~     stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean~     cerebral blood flow velocity in the flat down compared to the upright head position, as~     assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior~     circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down~     head position improves neurological status at 7 days and disability at 90 days.~   "
103215|NCT01706081|"~     This study is being done because women have arm swelling for more than 6 months despite~     wrapping and other treatments. This swelling is called lymphedema. It is the back up of~     lymph system fluid that causes swelling in the arm. The swelling can just happen, but more~     commonly it is caused when lymph nodes are removed during cancer surgery. It can develop~     right after breast cancer treatment or weeks, months or even years later. In our preliminary~     research, the investigators found that more than 1/3 of the 33 patients showed at least a~     30% reduction in lymphedema following acupuncture treatment and there were no serious~     adverse events during the treatment or 6 month followup.~      This study will include a larger group of patients. Patients will be assigned to one of two~     groups, and results of the groups will be compared to see if acupuncture can reduce~     lymphedema and whether the effect lasts after acupuncture treatment is completed.~   "
103216|NCT01706068|"~     Background:~      The importance of ischemic ECG changes including St segment elevation, ST segment depression~     or T wave inversion that indicate myocardial ischemia are well established and require~     appropriate investigation and treatment.~      However, there is an abundance of clinical situation, with apparently ischemic ECG change~     not indicate traditionally coronary artery related ischemia and therefore require prompt~     recognition and treatment of underlying condition, that may be serious and life-threatened.~     For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte~     abnormalities, intracranial hemorrhage and hypothermia.~      Together with them, an ECG ST segment changes may appeared in abdominal serious illness such~     as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various~     vasoactive and toxic for myocardium substances released, the cause of ST segment changes in~     cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma~     rennin activity resulted by distension of the gallbladder.~      The certain proportion of the patients with ECG changes actually didn't have coronary artery~     disease(9,15) or other acute cardiac condition and therefore require treatment of the~     underlie illness only without spend the time for cardiac investigation or special~     treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with~     abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or~     unnecessary cardiac catheterization.~      In the medical literature the investigators found some case reports and works about the ECG~     changes in acute biliary disease in patient with knowing cardiac disease and without it, but~     actually incidence of ECG changes that suggest but not represent an acute coronary illness~     isn't knowing.~      Therefore this is necessary to investigate actually incidence of ECG changes that mimic~     acute coronary syndrome in acute cholecystitis and acute biliary disease and determined~     clinical and laboratory characteristics that helps to differentiate this patients.~   "
103217|NCT01706055|"~     This will be prospective, multicentre, observational study. Patients who will initiate~     treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0)~     i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient~     demographics, medical history data, safety parameters, presence of flu-like symptoms and~     measures to prevent or treat these symptoms will be collected.~   "
103218|NCT01706042|"~     Dietary prevention strategies are increasingly recognized as essential to combat the current~     epidemic of obesity and related metabolic disorders. The purpose of the present study was to~     evaluate the potential effects of legumes in relation to cardiometabolic risk markers and~     appetite regulating hormones.~   "
103219|NCT01706029|"~     Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the~     priority domain of improvement for the patients instead a good control of the inflammatory~     disease by treatments, even biotherapeutics .~      Some studies show that less than 50 % of the patients is satisfied by the care of the pain,~     whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a~     complex and multifactorial subjective phenomenon requiring a multidimensional evaluation,~     while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain~     in a single dimension that is the pain intensity.~      So, the investigators do not arrange explanation for this observed dichotomy between the~     improvement of the clinical and biological inflammatory criteria of the RA and on the other~     hand the persistence of pain.~      On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the~     physiopathology of RA and probably in the pain processing according to recent data of the~     literature.~      The aim of this study is:~        -  to assess the multidimensional origin of the pain in RA patients by means of~          questionnaires~        -  to look for a possible correlation between the serum level of cytokines and pain.~   "
103220|NCT01706016|"~     Demonstrate the effectiveness of laser in the treatment of cancerous lesions by~     determinating with histological analysis of the specimen the percentage of tumor cells~     remaining in the area treated by the laser~   "
103221|NCT01706003|"~     Patients will be randomly assigned to receive their follow-up care via telemedicine or~     in-office visits.~   "
103223|NCT01705977|"~     The purpose of this study is to further enhance the existing knowledge regarding the side~     effects of belimumab when given with other lupus medicines to adults with active systemic~     lupus erythematosus (SLE). This study mainly focuses on collecting information on serious~     events that are not that common or may only be seen with long-term treatment. These events~     include death, serious infections and other infections of interest, cancers, serious mental~     health problems, including depression and suicide, and serious infusion and hypersensitivity~     reactions. This study is being done to help understand if treatment with belimumab increases~     the risk for these types of events. This study will also see if patients receiving belimumab~     with other lupus medicines can reduce their use of steroids, such as prednisone, over 1~     year.~   "
103224|NCT01705964|"~     Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled~     bronchodilators (β2 agonists) for children with severe asthma exacerbation.~      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2~     agonists) for children with severe asthma exacerbation.~      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose~     of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects~     20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly~     by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23~     gauge one inch needle.~      In addition to the study intervention, the standardized treatment pathway based on the~     current asthma guidelines in use at the investigator's center will be utilized. This pathway~     includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The~     duration and dosages of these other interventions will be administered at the discretion of~     the treating provider.~   "
103225|NCT01705951|"~     This project is prompted by the urgent public health need to identify novel strategies to~     prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data~     that suggests cessation of smoking results in rapid amelioration of endothelial function.~     The higher prevalence of CVD and metabolic syndrome in smokers have become major health care~     concerns. Therefore, finding optimal intervention strategies to combat these growing~     epidemics is imperative. We are investigating the efficacy of resistance training to~     ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance~     in four groups: presence or absence of resistance training with or without cessation~     treatment + nicotine replacement.~      The investigators hypothesize that resistance training will improve cardiovascular function~     in smokers; however, the responses will be better in those who also stop smoking. In~     addition, resistance training will decrease smoking, however, the effects of counseling and~     nicotine replacement alone or counseling and nicotine replacement in conjunction with~     resistance training will be better than resistance training alone.~   "
103226|NCT01705938|"~     This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,~     escalating, single-dose, study designed to evaluate the safety, tolerability,~     pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333~     tablets.~   "
103227|NCT01705925|"~     The purpose of the study is to provide comprehensive follow-up in patients with Long QT~     Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and~     effective management and treatment options.~   "
103228|NCT01705912|"~     The purpose of this study is to assess effects of a home exercise program, supervised by~     assistant nurses with the aim of preventing falls.~      Community living persons 65 years of age or older having a risk of falling were invited to~     participate. Participants were randomized to either training or control.~      The training program was individually designed by a physiotherapist and the 5-month program~     performance was supervised in the partcipants home by eight home visits from an assistant~     nurse.~      All participants received a visit from an occupational therapist who assessed the home and,~     if necessary, gave advice.~   "
103229|NCT01705899|"~     Islet transplantation can provide physiologic insulin replacement to patients with type 1~     diabetes without the complications associated with whole pancreas transplantation. The~     purpose of this study is to achieve insulin-independence in patients with type 1 diabetes,~     thereby eliminating the need for exogenous insulin injections to maintain normal glucose~     levels, ameliorating severe hypoglycemia and potentially decreasing the development of~     diabetes-related complications. This study will investigate islet transplantation in~     subjects who have preserved renal function and subjects who have undergone cadaveric renal~     transplantation, since the latter subjects are already on immunosuppression.~      This is a single center, prospective trial of islet transplantation in subjects receiving~     islets alone or islets after kidney transplant. This is a phase I study investigating the~     use of islet transplantation for the treatment of type 1 diabetes. Subjects will be eligible~     for an islet transplant if they meet all of the inclusion criteria and none of the exclusion~     criteria outlined in the protocol. In brief, the aims of this study are to establish an~     islet transplant program at the Ohio State University, determine the safety of islet~     transplantation in islet alone and kidney transplant recipients, determine whether islet~     transplantation will reduce the frequency of severe hypoglycemic events, determine whether a~     novel steroid-free immunosuppressive protocol will prevent rejection in islet transplants~     and to achieve insulin independence at one year after the final islet transplant.~   "
103230|NCT01705886|"~     The purpose of this study is to document and compare the surgical and after surgery costs,~     recovery time, and outcomes of two procedure types:~        -  Robotic assisted surgery replacing one compartment of the knee~        -  Manual (robot is not used) surgery replacing all three compartments of the knee (total~          knee replacement)~      The hypothesis is that robot assisted partial knee replacement is cost effective and~     provides clinical outcomes that are equivalent to a manual total knee replacement.~   "
103231|NCT01705873|"~     The objective of this study is to evaluate changes in Framingham score (from low to~     moderate, from moderate to high) based on changes in lipid profile and other parameters from~     baseline to 48 weeks of HAART in naïve patients or patients in second line of treatment,~     considering LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased~     Framingham score in patients treated with LPV/r as second line treatment and in patients~     treated with LPV/r or EFV regimen as first line treatments.~   "
103310|NCT01704833|"~     The main objective of this study is to determine the preliminary efficacy of~     Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) relative to standard care in the~     treatment of persecutory delusions in patients diagnosed with schizophrenia or~     schizoaffective Disorder.~   "
103232|NCT01705860|"~     The present study will evaluate the long term effects on scar formation for~     dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white~     petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small,~     experimental, cutaneous wound to evaluate both time to complete wound closure and quality of~     the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.~   "
103233|NCT01705847|"~     This study is to determine the appropriate dosing regimen of GS-9820 in subjects with~     lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study~     evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of~     GS-9820.~   "
103234|NCT01705834|"~     This study will investigate if an electronic dataglove can be used to measure joint~     stiffness in patients with Rheumatoid Arthritis.~   "
103235|NCT01705821|"~     This study is designed to measure forces applied using standard surgical instruments at the~     skull base during resection of skull base lesions. This data will be useful for optimizing~     an active canula robot for assisting in skull base surgery. We hypothesize that through~     measurement of forces generated during routine endoscopic skull base surgery we will be able~     to optimize the canulas of an active canula robot for skull base surgery.~   "
103236|NCT01705808|"~     Severe sepsis and septic shock are life threatening medical emergencies and are among the~     most significant challenges in critical care. Case reports and case series suggest that~     plasma-derived protein C concentrate may improve the outcome of patients with acquired~     protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway~     in modulating overwhelming inflammation and preventing coagulation derangements, two key~     mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience~     collected through these studies shows that PC is safe, in that it is not associated with~     bleeding or severe allergic complications,and possibly useful, at least to improve the~     coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes~     from case series or case reports or an underpowered randomized controlled study. A~     randomized clinical trial, adequately powered for mortality or clinically relevant outcome,~     is necessary to confirm PC efficacy.The aim of this study is to demonstrate that Protein C~     zymogen has clinically relevant implications in terms of reduction of thromboembolic events,~     30 days mortality, length of intensive care and hospital stay, time on mechanical~     ventilation, length of ICU and hospital stay. The study will also confirm that there is no~     bleeding concern with the use of Protein C concentrates.The study drug will be administered~     in the Intensive Care Unit for 72 hours and the patients observed till ICU discharge.~     Telephone followup will be performed at 30 days and at one year.~   "
103237|NCT01705795|"~     Randomized, placebo-controlled, double-blind study evaluating the effect of~     anti-IL-5-therapy in patients with bullous pemphigoid. The primary study objective is to~     determine the efficacy of an anti-IL-5 monoclonal antibody therapy, administered as 750mg~     mepolizumab, in patients with bullous pemphigoid.~   "
103238|NCT01705782|"~     The purpose of the study is to investigate the metabolic effects during acute inflammation~     with and without the nutritional supplement of amino acids.~      E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.~      The study is an interventional randomized placebo study including 8 healthy male subjects.~     Each subject participates 3 times (different days) and are given one of following~     interventions:~        -  Placebo (NaCl)~        -  Endotoxin, US standard reference E.Coli + Placebo (NaCl)~        -  Endotoxin, US standard reference E.Coli + Amino acids (intravenously)~      It is our hypothesis that the nutritional intervention during acute inflammation plays an~     important role in lipid and protein metabolism.~   "
103239|NCT01705769|"~     This project aims to assess the efficacy of three options under consideration in India for~     home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a~     multi-center randomized controlled trial to determine the efficacy of two~     community-supported home-based regimes using centrally or locally produced Ready to Use~     Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management,~     compared with an augmented home-prepared foods regimen. The trial will enroll 911 children~     with uncomplicated SAM and will have enough statistical power to detect a 15% or greater~     difference in recovery rates between either one of the intervention groups compared with~     comparison group.~   "
103240|NCT01705756|"~     FMF is the most common periodic fever with a worldwide patient population estimated as~     150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established~     therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot~     tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful~     attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive~     amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to~     underlie the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β~     related burst of inflammation.~      The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response~     to the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last~     few years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also~     in children ,however, no controlled study has thoroughly evaluated the efficacy and safety~     of this treatment.~      Study outline:~      The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000~     patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist,~     Kineret (Anakinra), on the frequency of FMF attacks in patients that, despite maximum~     tolerable dose of colchicine, present with more than one attack per month.~      The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients~     will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4~     months.~   "
103241|NCT01705743|"~     In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide~     on cerebral electrical activity, the investigators determined the MAC of sevoflurane~     combined with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the~     subjects (MACie) in middle aged subjects.~   "
103242|NCT01705730|"~     This observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid~     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the~     licensed label will be followed for 6 months.~   "
116677|NCT01528826|"~     The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus~     oxaliplatin in pretreated metastatic triple-negative breast cancer.~   "
103243|NCT01705717|"~     This retrospective, observational study will assess the real world treatment out comes in~     the management of patients with chronic hepatitis C. No prospective ass essment or procedure~     with patients during this study will be conducted. Data wil l be collected from patient~     medical records of the year 2000-2011.~   "
103244|NCT01705704|"~     This retrospective study will evaluate the association of biomarkers and the treatment~     response of patients with chronic hepatitis B, who have completed therapy with Pegasys~     (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from~     patients will be used; no actual patients are involved.~   "
103245|NCT01705691|"~     NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel~     followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with~     HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in~     the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary~     aim of the study is to determine the pathologic complete response (ypCR) in breast and~     axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include~     determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after~     eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year~     recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant~     regimens.~   "
103246|NCT01705678|"~     There is some evidence that dietary supplementation with fish oil has health benefits,~     especially in respect of some of the known risk factors for cardiovascular (heart) disease~     such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable~     to validate alternative sustainable sources of the important omega−3 fatty acid components.~     It has been suggested that oil from krill, which are small marine crustaceans, may be as~     effective or possibly more beneficial than fish oil, and may provide a more effective and~     beneficial supplement. Dietary management of cardiovascular health parameters (such as blood~     lipids)is becoming more and more important as the rising trends in obesity nationally and~     worldwide are leading to escalating incidence of diabetes and heart disease. The~     investigators propose to use some specific novel lipid measurements of cardiovascular risk~     to test this possibility in a group of men who, although generally healthy, show some risk~     factors in terms of their weight and metabolic profile.This pilot study will provide~     preliminary data to show whether krill oil has similar or different effects from fish oil on~     the cardiovascular health of overweight but otherwise healthy men, and in particular will~     provide detailed information on alterations in novel lipid markers of cardiovascular~     disease, which may be a better diagnostic tool than classical lipid measurements (e.g. serum~     cholesterol). The investigators have been developing and validating new techniques to~     measure emerging lipid markers of cardiovascular risk accurately and will continue to~     develop and investigate these techniques during the course of this project. The~     investigators hypothesise that krill oil will be more efficacious in reducing markers of~     risk relating to cardiovascular disease.~   "
103247|NCT01705665|"~     This study was initiated on the preliminary premise that a thrombus whose formation was~     triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue~     factor initiated thrombus), may evolve differently than the one evolving at the site of a~     recently implanted stent (foreign body triggered). Consequently, the thrombus composition of~     a de novo clot could differ from the other one, extracted during the occurrence of a~     subacute thrombosis, regarding the number of various cells, the amount of fibrin and~     platelet aggregates and the relationship among these components. In addition, it seems~     relevant to evaluate the numbers and the distribution of the local monocytes, once these~     cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1])~     and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident~     macrophages). Such a distinction, if eventually found, may reveal the mechanisms of~     thrombosis within coronary arteries, and may have clinical implications.~   "
103248|NCT01705652|"~     The purpose of the study is to (1) to determine the rate of PSA decline (the number~     declining). Tissue will be obtained for ancillary studies and (2) to determine the number of~     patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with~     standard radiation therapy. The Secondary Objective is to confirm the tolerability of this~     regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of~     Nexrutine®. Molecular response is defined as changes in the molecular pathways.~   "
103249|NCT01705639|"~     The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants~     of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3~     months:~        -  OGTT~        -  questionnaires about sleep and activity~        -  Actigraph~        -  Anthropometry~        -  Blood pressure~   "
103250|NCT01705626|"~     The purpose of this study is to determine the prevalence of patients with a polyneuropathy~     of undetermined etiology based on the normal results of laboratory data (CRP, glucose,~     electrolytes, urea,transaminases, TSH, immunoglobulins, vitamin B12, RF, ANA, antibodies~     against Lyme borrelia) no anamnesis for carcinoma, no continuous alcohol consumption; no~     light-chain-amyloidosis; no anamnesis for heavy metal exposure.~   "
103251|NCT01705613|"~     The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian~     children and adolescents, submitted to methylphenidate immediate-release treatment for~     Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale~     (HUI) will be completed by the patient and/or family, in two moments of an observation study~     with immediate-release methylphenidate: at the baseline and 6th month of treatment in the~     follow-up. The results provides information to calculate the utility measure and determine~     the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the~     treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation~     with 10,000 random trials.~      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose~     of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be~     evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by~     parents and patients (if >12 years old only) at baseline and 6th month. The period for~     inclusion of new patients comprises from 01/01/2011 to 31/12/2013.~   "
103357|NCT01704222|"~     Direct DNA amplification, viral isolation and specific antibody measurement in saliva from~     children attending nursery in France Sample collection will be done by the pediatrician the~     nurse, or one of the authorized investigators of the study.~   "
103252|NCT01705600|"~     The primary goal of this study is to examine the effects of limiting complaints on pain and~     pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of~     central sensitization (CS).~      The study will be performed on individuals who have LBP and are in a state of CS. CS is~     classified as a type of pain which has the following dominant features: pain that is~     disproportionate to the nature or extent of injury/pathology; disproportionate,~     non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing~     factors; strong association with maladaptive psychological factors~      ; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been~     demonstrated to have discriminative validity for diagnosing CS.~   "
103253|NCT01705587|"~     This open label comparison study examines the hypothesis that teriparatide given immediately~     following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will~     enhance healing and improve bone mineral density compared to delayed treatment (after six~     months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or~     for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition~     will have greater quality of life measures and less pain compared to those with delayed or~     no therapy.~   "
103254|NCT01705574|"~     This study will evaluate the safety, efficacy, and tolerability of a regimen containing~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)~     fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV) plus~     emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) in HIV-1 infected,~     antiretroviral treatment-naive adult women.~      This study will consist of two phases: Double-Blinded Treatment Phase (48 weeks) and~     Open-Label Extension (OLE) Phase (48 weeks).~      After 48 weeks of blinded treatment, participants will continue to take blinded study drug~     for 12 weeks and return for an Unblinding Visit at Week 60. Participants who are~     virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the~     option to enter the OLE Phase.~   "
103255|NCT01705561|"~     -  Assess the attitudes and feelings of premenopausal Latin American women towards the~          risk of loss their fertility by adjuvant chemotherapy.~        -  Correlate the attitudes with other variables including age at diagnosis, already having~          children, number of children, level of instruction, marital status, frequency of~          menstrual cycle.~   "
103256|NCT01705548|"~     This phase I trial studies the side effects and best dose of hypofractionated radiosurgery~     in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving fractionated~     stereotactic radiosurgery may kill more tumor cells~   "
103257|NCT01705535|"~     Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects~     2-12% of the adult population. It is a hidden problem - less than one third of the affected~     persons discuss the problem with their doctor. The condition has a negative effect on~     quality of life. It is associated with shame and limitation in social life, leisure,~     occupational and sexual activities.~      Pelvic floor muscle exercises with or without the use of biofeedback has been recommended~     and used for the treatment of fecal incontinence over the last decades. Several uncontrolled~     trials and some controlled trials have shown a positive effect of this training, but most of~     the trials are small and/or have methodological problems. Therefore there is to day still a~     lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of~     fecal incontinence.~      The aim of this study is to compare the effect of an individual physiotherapeutic supervised~     pelvic floor muscle training program with a control physiotherapeutic treatment (massage of~     the neck and back). Both treatments will be given parallel with standard information and~     guidance given by a nurse specialized in anal incontinence issues.~      Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and~     guidance by a specialized nurse, provides better effect to reducing fecal incontinence than~     control treatment and standard advice alone.~   "
103258|NCT01705522|"~     The investigators intend to assess the role of several biomarkers in the prediction of~     relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive~     score will be derived in order to assess the relapse risk at 1 year.~   "
103259|NCT01705509|"~     This is a proof of concept trial using ranolazine, a medication, in patients with known~     Coronary Artery Disease and reduced left ventricular function, EF < 40%. We propose that~     ranolazine therapy will result in demonstrative improvements in cardiac function that can be~     objectively assessed using the parameters measured with CPET. We propose that demonstrative~     improvement in CPET parameters on ranolazine will translate into improved patient outcomes~     for this patient population.~   "
103260|NCT01705496|"~     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic~     imaging agent for the detection of prosthetic joint infections in patients.~   "
103261|NCT01705483|"~     The purpose of this study is to determine the safety and tolerability and pharmacokinetics~     of ASP9853 combined with docetaxel or with paclitaxel in subjects with advanced~     non-hematologic malignancies.~   "
103262|NCT01705470|"~     The study Objective is to assess the clinical and echocardiographic changes of patients with~     systolic dysfunction receiving blood transfusion, with or without prior treatment with~     furosemide~   "
103263|NCT01705457|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor~     expression.~   "
103264|NCT01705444|"~     Acute urinary retention is considered one of the most common problems in the older age,~     especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary~     retention using the Foley catheter still causes problems at the level of patient movement~     and the daily exercises. However, with the emergence of a new device, the spanner,~     investigators believe that many of the above mentioned problems can be resolved. This tool~     may provide more freedom for the patient.~   "
103265|NCT01705431|"~     The purpose of the On Track intervention is to address a need raised by a day-treatment~     school in Lane County: Support for students transitioning from the day-treatment school~     (Lane School) to their district middle schools. Eligible students are currently attending~     Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and~     are preparing to transition to their district schools.~   "
103266|NCT01705418|"~     Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up~   "
103268|NCT01705392|"~     The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard~     chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to~     evaluate the predictive value of a set biomarkers associated with vascular endothelial~     growth factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing~     acquired resistance to treatment with bevacizumab and escape mechanisms caused by other~     angiogenic growth factors than VEGF. Finally, we want to analyze safety and influence on~     outcome variables by primary prevention of bevacizumab induced hypertension by low dose beta~     blockers in comparison with an ACE inhibitor.~   "
103269|NCT01705379|"~     A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure~     requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety~     evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving~     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.~   "
103270|NCT01705366|"~     The objective of this study is to document the demographic and clinical characteristics and~     the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.~      The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the~     knee joint has 10 year implant survival and clinical outcomes that are equivalent to other~     knee replacement systems.~   "
103271|NCT01705353|"~     The purpose of this study is to measure the presence of HMGB-1 and other proteins in the~     blood across five time points after stroke, and to determine if their presence correlates~     with rate of stroke recovery.~   "
103272|NCT01705340|"~     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 and~     lapatinib ditosylate when given together with trastuzumab in treating patients with locally~     advanced or metastatic human epidermal growth factor receptor-2 (HER2)-positive breast,~     gastric, or gastroesophageal cancer that cannot be removed by surgery. Akt inhibitor MK2206~     and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for tumor growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving Akt~     inhibitor MK2206 and lapatinib ditosylate together with trastuzumab may kill more tumor~     cells.~   "
103273|NCT01705327|"~     This is an observational, multi-center study to assess clinical features and biologic~     biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The~     primary objective of this study is to discover clinical and biologic markers of PD for use~     in clinical trials of disease-modifying therapies.~   "
103274|NCT01705314|"~     The goal of this study is to assess the effectiveness of vitamin D in reducing~     laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract~     infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha~     Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly~     vitamin D supplements or placebo. Participants who develop acute respiratory infection over~     a 12-month period, will be tested for influenza, the co-primary outcome, and other~     respiratory viruses, the other co-primary outcome, by RT-PCR.~   "
103275|NCT01705301|"~     In this study, the investigators will monitor extracellular neurotransmitter levels using a~     probe that is able to perform real time electrochemical detection during deep brain~     stimulation surgery. The overall question this study is designed to answer is: Are there~     neurotransmitters released during deep brain stimulation?~   "
103276|NCT01705288|"~     Over 600,000 hysterectomies are performed annually in the United States. Despite increasing~     use of less invasive approaches, the majority of hysterectomies are still performed via~     traditional laparotomy, which can be associated with generally slower recovery and longer~     lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize~     post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as~     possible following surgery.~   "
103277|NCT01705275|"~     A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity~     in healthy male adult volunteers.~   "
103278|NCT01705262|"~     The purpose of this study is to determine whether Moviprep or Phosphoral is the best method~     of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.~   "
103279|NCT01705249|"~     This study is conducted in Europe. The aim of this study is to investigate the bleeding~     profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg~     norethisterone acetate (NETA)).~   "
103280|NCT01705236|"~     This is a 3-year, prospective, multi-center, open-label study to describe the long term~     changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment~     with Fingolimod. It is designed to longitudinally study the degeneration of retinal axons by~     measuring change in RNFL thickness by latest OCT-technology. Correlations of OCT findings~     with available MRI data and clinical findings may enhance our understanding of the~     relationship between CNS inflammation, tissue injury, regeneration and neurological deficit~     in the context of fingolimod therapy.~   "
103281|NCT01705223|"~     This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by~     recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high~     risk of HIV infection. In addition, the effect of different intervals of the prime-boost~     will be studied.~   "
103282|NCT01705210|"~     The exact neuronal mechanism underlying the cognitive decline associated with diabetes~     mellitus type 2 (DM2) still remains to be elucidated. Multi-parametric functional MRI can~     potentially provide functional, micro-structural, micro-vascular, and metabolic information~     on the affected brain at an earlier stage than does conventional structural MRI. The overall~     aim of the current proposal is to obtain a better understanding in the neuronal mechanisms~     that underlie cognitive decline in DM2 and the putative prediabetic condition the metabolic~     syndrome (MetS).~   "
103283|NCT01705197|"~     The objective of this study is to evaluate the safety and efficacy of Avanafil in the~     treatment of erectile dysfunction with moderate to severe in subjects. And, this is to~     additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg~     and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in~     subjects.~   "
103358|NCT01704209|"~     The purpose of this study is to find out if autologous (your own) fibroblast injections are~     effective for the treatment of acne scars and wrinkles.~   "
103284|NCT01705184|"~     At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with~     platinum eventually associated with bevacizumab. A new treatment begins at progression.~      In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could~     be administered according to a stop and go strategy respecting therapeutic breaks between~     sequences of identical treatment. During these therapeutic breaks, a treatment of~     maintenance is possibly better than an absence of treatment. These plans benefit to the~     patients in terms of efficiency but also in terms of toxicity, in particular neurological.~      The question is to know if this strategy is feasible in lung cancer.~   "
103285|NCT01705171|"~     In this study we will investigate the expression of the fructose transport protein GLUT5 in~     the small intestine in patients with functional GI disoders and fructose intolerance~     compared to matched healthy controls.~   "
103286|NCT01705158|"~     The purpose of this study is to determine the efficacy and the safety of the association of~     carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive~     to platin.~   "
103287|NCT01705145|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and~     pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through~     5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in~     at least 1 allele.~      Part A is designed to evaluate the safety and PK of multiple-dose administration of~     ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part~     B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2~     through 5 years of age.~   "
103288|NCT01705132|"~     The purpose of the study is to determine if there are certain laboratory tests that can be~     performed to detect substances or features in a child's urine that can be used to measure~     the progress of Alport kidney disease and the effects of treatment. These tests and their~     results could be of use to measure responses to new treatments in future clinical trials.~   "
103289|NCT01705119|"~     The purpose of this study is to investigate how changing from a supine to upright position~     affects gas exchange for patients with hypoxemic respiratory failure.~      The research question is: will oxygen saturation and/or partial pressure of oxygen in the~     blood change when a patient with hypoxemic respiratory failure moves from a supine to~     upright position?~   "
103290|NCT01705106|"~     This clinical trial studies capecitabine and celecoxib in treating patients with solid~     malignancies that are metastatic or cannot be removed by surgery. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     capecitabine and celecoxib together may be an effective treatment for solid malignancies.~   "
103291|NCT01705093|"~     The prevalence of childhood obesity has been increasing over the past couple of decades.~     Similar to adults, overweight and obesity in young children and adolescents is associated~     with an increased number of cardiovascular risk factors including dyslipidemia,~     hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies~     suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape~     products, tea, citrus fruits, and strawberries are protective against the development of~     cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins,~     flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro~     studies have observed that these isolated compounds, as well as strawberry extracts have the~     potential to affect outcomes of cardiovascular health, including vascular reactivity,~     cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead~     to improvements in select measures of cardiovascular function in overweight and obese~     adolescent males.~   "
103292|NCT01705080|"~     The purpose of this post market clinical investigation is to further evaluate the safety and~     performance of the EnligHTN™ Renal Denervation System in the treatment of patients with~     uncontrolled hypertension.~   "
103293|NCT01705067|"~     Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with~     degenerative knee disease requiring primary total knee replacement.~   "
103294|NCT01705054|"~     The purpose of this study is describe the frequency of chest pain and how chest pain impacts~     patients' quality of life in the outpatients with chronic coronary artery disease in~     contemporary cardiology practice settings.~   "
103295|NCT01705041|"~     The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase~     test with the standard of care test used in an HIV clinic at the Hospital for Tropical~     Diseases in Ho Chi Minh City, Vietnam.~   "
103296|NCT01705015|"~     The aims of this 3-year randomized, single-blinded clinical trial are to compare the effect~     of high and low feedback about performance on the bedside exercise device in heart or liver~     transplantation recipients during the hospitalization immediately after transplantation. The~     hypotheses of the study are heart/liver transplantation recipients who have high feedback~     about performance on the bedside exercise device will progressively increase their level of~     exercise over the course of their hospitalization, more independent in ambulation level,~     better walking speed and 6-minute walk test at discharge, and better cardiorespiratory~     fitness at 4-8 weeks after transplantation than those who receive low feedback. The adult~     patients who newly receive heart or liver transplantation at National Taiwan University~     Hospital will be evaluated for eligibility of the study in the acute postoperative period.~     The study will be conducted in both the intensive care unit and ward environments. The study~     subjects will be randomized to either high or low feedback about performance on the bedside~     exercise device which uses hand/foot pedals that record exerted forces against adjustable~     resistances, measure repetitions of upper and lower extremity cycling movements, and give~     feedback about performance via a wireless internet connection. The study will also monitor~     the amount of daily movement activity of all subjects in this trial by using triaxial~     accelerometers, and the activity recognition algorithms developed by engineers and computer~     scientists at University of California Los Angeles. The outcome measures include level of~     independence for walking, walking speed, 6-minute walk test, and cardiopulmonary exercise~     testing by the blinded observers. The study expects to enroll at least 50 heart~     transplantation recipients and 60 liver transplantation recipients in 3 years. The results~     of this study will offer much insight into activity levels of heart or liver transplantation~     recipients during early postoperative period. Besides, heart transplantation recipients will~     receive routine phase I cardiac rehabilitation program by the physical therapists during the~     study but not liver transplantation recipients. We might be able to evaluate the interaction~     effects of routine physical therapy and UCFit exercise among our study subjects. Our data~     will also provide insight into just how active or inactive transplantation recipients may be~     and help generate ideas of organ transplantation rehabilitation program to increase their~     fitness-related activity prior to discharge.~   "
103308|NCT01704859|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,874 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and~     will examine whether vitamin D or fish oil will (1) reduce incident total fractures and (2)~     reduce incident hip and non-vertebral fractures.~   "
103297|NCT01705002|"~     This is a Phase I, multi-center, Dose-Escalating, Safety Study of an Intravenously~     Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in~     Cancer Patients with Solid Tumors. The study comprised of:~      Escalated cohorts A-H: 27 male or female participants, ages 18-80, BMI 18-36 diagnosed with~     inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have~     failed to respond to standard therapy or for whom no standard therapy is available. Eligible~     subjects will be assigned, successively in order of accrual, to one of eight cohorts, to~     receive escalating doses of intravenously infused PROMITIL. PROMITIL will be administered as~     an intravenous infusion. Dose escalation will only proceed in the absence of dose-limiting~     toxicity (DLT). For this purpose, each cohort will only begin its first cycle of PROMITIL~     when the cohort preceding it has successfully completed its first 4-week cycle without any~     signs of DLT.~      Expanded cohort: 17 adult patients with metastatic CRC. The purpose of this expanded cohort~     is to further evaluate the safety of Promitil and to search for signs of antitumor activity~     of Promitil in this specific patient population.~      Combination Cohort (Promitil concomitantly with Capecitabine): 23 adult patients with~     metastatic CRC.~   "
103298|NCT01704989|"~     A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk~     factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for~     approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this~     region an ideal setting for studying patients with this condition. Despite associated high~     morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge~     for the clinician. Topical medical therapy is less effective than for primary open angle~     glaucoma and patients often require early surgical therapy, with associated risks. Selective~     laser trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative~     glaucoma, although the evidence for this is presently lacking. The aim of the current study~     is to provide the first controlled-trial evidence for the effectiveness of SLT, compared to~     topical therapy, in the management of pseudoexfoliative glaucoma.~   "
103299|NCT01704976|"~     This randomized controlled study aims to examine long term effects in the skilling up phase~     over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance~     therapy intervention in a frail elderly population.~   "
103300|NCT01704963|"~     The purpose of this study is to evaluate the safety and tolerability of Bruton's Tyrosine~     Kinase (Btk) Inhibitor PCI-32765 in Japanese patients with recurrent mature B-cell~     neoplasms.~   "
103301|NCT01704950|"~     The aim of this study is to provide data and the guidelines for the use of IDRT SL in small~     wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of~     this product as a one stage procedure.~   "
103302|NCT01704937|"~     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool~     transplant from a healthy individual to a C. difficile-infected recipient, and has long~     been a successful approach to recurrent/refractory C. difficile. The purpose of this project~     is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can~     be used repeatedly, particularly in those who do not have a healthy intimate partner or~     other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention~     enema, or by the nasogastric route. This study will evaluate the safety and secondarily the~     efficacy of a frozen inoculum administered by nasogastric tube vs administered by~     colonoscope.~      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via~     either:~        -  colonoscopy~        -  NGT~      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,~     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.~     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a~     normal bowel status for the individual. Secondary efficacy endpoints include weight,~     subjective well-being and relative clinical improvement per standardized questionnaire, and~     subject qualitative assessment of, and satisfaction with, the transplant procedures.~     Subjects will be monitored for clinical safety by history and standard exams and the~     follow-up questionnaire as well as followed closely by phone and in person.~   "
103303|NCT01704924|"~     This study aims to assess the quality of wound healing in abdominal scars with and without~     the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved~     wound healing with less swelling, bruising, and inflammation, as well as less potential for~     infection, seroma, and dehiscence.~   "
103304|NCT01704911|"~     The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the~     transradial coronary intervention (TRI) in comparison with the transfemoral coronary~     intervention (TFI).~   "
103305|NCT01704898|"~     The primary objective of this study is to determine the average bioequivalence of a generic~     efavirenz 600 mg tablet (test formulation)compared with Stocrin(R) 600 mg tablets (Reference~     formulation).The study is designed as an open label, randomized, crossover, 2-treatments,~     2-period, 2-sequence, single dose pharmacokinetic study conducted in healthy volunteers.~     Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or~     Stocrin(R) 600 tablets (Reference formulation)on study day 1 (period 1). Subjects will~     undergo a 24 hour intensive pharmacokinetic evaluation after ingesting a single dose of~     either the Test or Reference formulation. Subjects will provide additional pharmacokinetic~     samples 36, 48, 72, 120 and 192 hours postdose, respectively. Subjects will complete a wash~     out period from day 8 to day 28 during wich no study drug will be ingested. On day 29~     subjects will ingest either the Test or the Reference formulation (opposite to the~     formulation received on period 1). All subjects undergo another 24 hour intensive~     pharmacokinetic evaluation and pharmacokinetics samples on days 36, 48, 72, 120, 192 pos~     dose, respectively. Adverse events and and concomitant medication will be documented~     throughout the study.~   "
103306|NCT01704885|"~     The goal of this study is to determine whether a brief (three 20-30 minute session)~     cognitive-behavioral play intervention will improve coping skills and adjustment for~     siblings of children diagnosed with cancer.~   "
103307|NCT01704872|"~     The purpose of this study is to assess the safety, pharmacokinetic and activity profiles of~     the ch14.18 antibody produced in cells of hamster origin (ch14.18/CHO).~   "
103309|NCT01704846|"~     The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg~     BI 201335 NA soft gelatine capsules.~   "
131401|NCT01335321|"~     The purpose of this study is to evaluate if the investigators can achieve better early~     outcomes adding triamcinolone to the viscosupplementation procedure.~   "
103311|NCT01704820|"~     Colonoscopy is the gold standard screening test for colorectal cancer. Removal of~     pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over~     50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon~     cancers, it provides only limited protection from cancer in the proximal (right side) colon.~     Our goal is to determine if additional pre-cancerous colon polyps can be identified by~     looking at the right side of the colon in retroflexion. During retroflexion the tip of the~     colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds.~     If additional polyps can be identified in this manner colonoscopy will become a more~     efficient method of screening for colon cancer.~      In order to evaluate how effective right colon retroflexion is at detecting polyps in the~     proximal colon we plan on performing a randomized, controlled trial. Patients undergoing~     screening or follow up colonoscopy will be invited to participate in the study. Those~     patients who agree to participate will be randomized into one of two groups once the~     colonoscope is fully inserted. Group one will have the right side of their colon examined~     for polyps with the endoscope looking forward (traditional form of examination) followed by~     repeat examination of the right side of the colon with the colonosocpe in retroflexion~     (looking backwards). Polyps seen during each section of the exam will be removed and manner~     in which the polyps were found/ removed will be recorded. Following the two exams of the~     right side of the colon the colonoscopy will be completed in the usual manner. The duration~     of each portion of colonoscopy will be recorded. After the procedure is completed the~     physician performing the colonoscopy will rate difficulty of the procedure and confidence~     with quality of the examination. Pathology results for each polyp will be recorded once~     available. There will be no study related follow up after the pathology results are~     recorded.~   "
103312|NCT01704807|"~     Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo~     foot inserts on the duration of chiropractic correction of spinal fixations and muscle~     imbalances using applied kinesiology techniques.~   "
103313|NCT01704794|"~     The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum~     bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione~     reductase in patients with sickle cell disease and to determine if there is any improvement~     in the quality of life of the patients.~   "
103314|NCT01704781|"~     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced~     immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV~     immunotherapy and the primary objective is to strengthen the immune system's response to HIV~     p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is~     anticipated that the effect of Vacc-4x might be enhanced.~   "
103315|NCT01704768|"~     The prevention and treatment of obesity and mental health disorders in adolescence are two~     major public health problems in the United States today. To address the increasing incidence~     and adverse health outcomes associated with both obesity and mental health problems, a~     theory-based 15 session intervention program entitled COPE (Creating Opportunities for~     Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions & Exercise), will~     be delivered within high school health classes in order to improve the physical and mental~     health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).~   "
103316|NCT01704755|"~     The purpose of this study is to evaluate the safety and efficacy of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with~     ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated~     cirrhosis.~   "
103317|NCT01704742|"~     This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's~     lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses~     like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma~     Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will~     let the resesarchers look at their medical record, follow their normal cancer care, and have~     blood drawn to look at different proteins and viruses. Researchers would also like to look~     at part of the original tumor that was taken out of each patient. Some of these samples will~     be stored at Kenyatta National Hospital and research will be done on them later. This study~     does not involve any change in treatment, but only allows the study team to follow how a~     patient in Kenya with lymphoma is treated.~   "
103318|NCT01704729|"~     Phase I: Focus groups on different designs of adjustable glasses and standard glasses~     (August-September 2012) Phase II: Two-month randomized trial comparing four groups:~     (September 2012 - August 2013)~   "
103319|NCT01704716|"~     This is a randomised study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk~     neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non~     amplified > 12 months at diagnosis).~      The protocol consists of a rapid, dose intensive induction chemotherapy (R3 randomisation -~     Rapid COJEC vs modified N7), peripheral blood stem cell harvest, attempted complete excision~     of the primary tumour, myeloablative therapy (BuMel) followed by peripheral blood stem cell~     rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomisation -~     isotretinoin and ch14.18/CHO, with or without aldesleukin (IL-2).~      In the induction phase, all patients with stage 4 neuroblastoma and those with stage 4s~     MYCN-amplified neuroblastoma will be randomised (R3) to Rapid COJEC or modified N7;~     localised patients receive Rapid COJEC (Rapid COJEC is given with G-CSF support based on the~     results of the R0 randomisation running between 2002 and 2005).~      Following induction treatment peripheral blood stem cell harvest (PBSCH) will be performed~     and complete excision of the primary tumour will be attempted.~      Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the~     end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.~      After Rapid COJEC induction, localised patients will proceed to consolidation. Patients aged~     12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without~     segmental chromosomal alterations (SCA) are thought to have a good prognosis and will stop~     treatment after induction therapy and surgery to the primary tumour.~      Consolidation consists of BuMel MAT (following the results of the R1 randomisation) followed~     by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary~     tumour.~      During the immunotherapy phase, patients will be randomised (R4) to immunotherapy with~     isotretinoin (13-cis-RA) and ch14.18/CHO, with or without aldesleukin (IL-2).~   "
103320|NCT01704703|"~     Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with~     next generation high sensitivity genotyping of patients with stage IV colorectal cancer~     refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected~     with highly sensitive techniques.~   "
103321|NCT01704690|"~     Esophageal cancer is one of the common malignant disease, especially in China. The annual~     incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The~     prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at~     diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%.~     Though some patients received surgical treatment, disease will recurrent and metastasis in~     nearly 90% of the patients.~      In past decades, there isn't much improvement of the outcome and survival of advanced~     esophageal cancer due to the lack of effective chemotherapy agents. The traditional~     chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results~     in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus~     cisplatin regiment is another promising treatment of esophageal cancer and have been proved~     effective in many studies. One of our previous study showed paclitaxel and cisplatin~     treatment resulted in encouraging response rate with manageable side-effects in 131 patients~     of advanced esophageal cancer.~      However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For~     example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity~     reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and~     neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of~     them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney~     disease which cause varying damages of renal function and limit the use of cisplatin in~     these patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in~     the combination chemotherapy treatment.~      Therefore, the investigators designed this randomized clinical trial in which a novel~     combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in~     compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and~     toxicity. The investigators hope this study will provide some clues for the treatment of~     esophageal cancer patients.~   "
131416|NCT01335126|"~     The purpose of this study is to evaluate the performance between two emulsion-type~     artificial tears.~   "
103322|NCT01704677|"~     During the past 25-30 years, surgery with total disc replacement (TDR) has become an option~     for a selection of patients with chronic low back pain (LBP) traditionally treated~     conservatively or operated on with spinal fusion. Randomized trials comparing TDR with~     fusion have found the clinical outcome of TDR at least equivalent to that of fusion, and the~     only study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that~     TDR is significantly more effective than multidisciplinary rehabilitation (REHAB) after 2~     years. However, the long-term effects of TDR in terms of clinical results, costs,~     reoperation- and revision rate, degenerative changes and prognostic factors have not been~     investigated in high quality prospective trials. This is very much required since TDR~     surgery is offered a great number of patients world wide, and is associated with high~     complexity and risk of serious complications and difficult revision. Hence, the overall aim~     of the present study is to evaluate the long term (eight years follow-up) effect of The~     Norwegian TDR study where TDR surgery were compared to modern multidisciplinary~     rehabilitation in patients with chronic low back pain and localized degenerative disc~     changes.~   "
103323|NCT01704664|"~     Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity~     and may improve quality of their life. Patients with gastric cancer will be divided into~     four groups depending on the type of artificial nutrition. Group I (enteral feeding) and II~     (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional~     therapy during the postoperative period, group III (oral arginine) and IV (parenteral~     immunonurition) patients will be treated nutritionally both prior to and after the surgery.~     The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and~     bactericidal activity of blood platelets will be determined before and after nutritional~     therapy.~   "
103324|NCT01704651|"~     This study is designed to determine whether an oral perioperative medication (alvimopan--a~     selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian~     cancer.~   "
103325|NCT01704638|"~     The investigators will compare plasma kinetics of two marker drugs in individuals with~     different genetic variations in the MDR1-gene. The hypothesis is that one group will have~     higher exposure than the other.~   "
103326|NCT01704625|"~     PURPOSE The purpose of this research is to determine whether osteopathic manipulative~     therapy (OMT) is a useful adjunct in evaluation and treatment of headaches.~      PROCEDURES If a practitioner determines that a patient has a significant headache he/she may~     order tests. He/ She may give the patient medications to treat the headache.~      The investigators will also ask permission to evaluate and treat the headache using~     osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation~     and treatment will be performed by an emergency medicine resident. Osteopathic evaluation~     and OMT is not standard of care for this condition. The investigators also may call the~     patient in 7 days to see how they are doing.~      The investigators wish to see if emergency medicine physicians can use osteopathic~     evaluation and OMT to reliably treat headaches. The results of the examination and treatment~     will be recorded, but will not be used to change treatment or to change additional tests.~     The investigators wish to see whether in the future they can use OMT in certain cases~     instead of or in conjunction with medications. The investigators plan on asking 50 patients~     to participate.~   "
103327|NCT01704612|"~     Diabete animal studies demonstrated a longer period recovery after local anesthetic~     injection (perineural administration). No clinical study demonstrated a prolonged nerve~     block duration in diabete type 2 patients after peripheral nerve block. The investigators~     hypothesized that block recovery is delayed in diabetic patients.~   "
103328|NCT01704599|"~     Vitamins modulating homocysteine affect both TNF-alpha, vascular endothelial growth factor,~     and theoretically enhance the anti-inflammatory version of NOS thus hopefully increasing the~     efficacy and reducing the chance of some toxicities of adalimumab as determined by blood~     testing and EKGs.~   "
103329|NCT01704586|"~     Thyroid nodules are a common clinical problem. Epidemiologic studies have shown the~     prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living~     in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as~     Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid~     cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary~     and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany,~     approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased~     from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be~     continuing. Recurrence-free survival is generally excellent and depends on the risk group.~      The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question~     regarding the initial management of DTC still needs to be resolved even after decades of~     radioiodine use. American Thyroid Association directions for future research addressing~     these questions include:~        -  Better understanding of the long-term risks of radioiodine use;~        -  Improved risk stratification;~      Randomized controlled trials are still missing in which RRIA has proven its worth as a safe~     and very effective treatment that results in an improved life expectancy and a reduced~     recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade~     is rated mainly on expert level, based on non-randomized retrospective observation~     studies. Although RRIA in Europe is established as adjuvant standard treatment for all~     patients with DTC, except those with stage T1a, it remains to be shown throughout if it is~     beneficial for low risk and medium risk patients without metastases (M0), also known as~     stage I patients according to UICC/AJCC classification, accounting for 40-90% of all~     patients.~      Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an~     average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not~     insignificant. The question is whether or not the condition after remnant ablation justifies~     such an increased risk of a secondary malignancy. The probability of causation for a~     pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA~     or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though~     radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still~     unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of~     life may be affected by adjuvant use of I-131.~      Study Hypothesis:~      The I-124 study arm may have considerable benefits for the patient included in the study.~     These include~        -  enhanced tumour and risk stratification,~        -  avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were~          classified with low risk tumour (MACIS or AMES scoring) or stage I disease~          (UICC-AJCC TNM staging system), and,~        -  improved quality of life at the same or better morbidity and mortality rates in the~          I-124 arm.~      Environmental and hospital staff related benefits include prevention or saving of I-131~     exposure.~      This study is designed to compare effectiveness of treatments following and evaluating~     guideline recommendations in two assignment arms.~   "
103330|NCT01704573|"~     This positron emission tomography (PET) study examines the effects of 24 hours abstinence~     from smoking on return to availability of neuronal nicotinic receptors in slow and fast~     metabolizers of nicotine.~   "
103331|NCT01704560|"~     Well-informed potential subjects are presumably better able to make autonomous decisions~     about the risks and benefits of participating in a research study than those in possession~     of less information. In actuality, prior research into consent understanding suggests that~     longer forms offering exhaustive information may inhibit rather than promote understanding.~     Moreover, technical wording in tools used to measure parent understanding of research~     permission may also lead to inhibition of understanding. This study will test the hypothesis~     that, among parents of potential subjects for greater-than-minimal-risk research, two~     modified and simplified subset of questions from the Deaconess Informed Consent~     Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice,~     will increase subject understanding of the nature and risks of the research. The study will~     enroll the parents of 40 potential neonatal research subjects with an interim analysis of~     data at 20 subjects. Subjects will review a sham research permission form and will be~     randomized 1:1 to complete one of the two modified comprehension tests in addition to the~     DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in~     order to qualitatively describe their opinions of each test. A subset of parents who have~     received the written form will also undergo a cognitive interview about the form. A similar~     subset will also be given an open-ended survey about a proposed permission form cover sheet.~     The primary outcome will be the correlation of scores between the DICCT and modified~     comprehension tests, following the sham informed consent process.~   "
103332|NCT01704547|"~     The study is designed to assess the accuracy of patient breast reproducibly using the~     revised BCID. This study would provide data for target verification and quality assurance to~     eventually allow treatment of breast cancer patients for either a TBB or accelerated partial~     breast irradiation. The BCID is a low-risk device similar to immobilization devices used~     routinely in radiotherapy for other disease sites.~   "
103333|NCT01704534|"~     The purpose of this study is to determine whether ustekinumab is effective in the treatment~     of moderate to severe hidradenitis suppurativa.~   "
103334|NCT01704521|"~     This study will examine viral dynamic responses in subjects with chronic hepatitis C and~     hemophilia when treated with pegylated interferon + ribavirin and telaprevir.~   "
103335|NCT01704508|"~     Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine~     and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin~     derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended~     for the treatment of malaria in Africa. However, artemisinin resistance appears to be~     developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently~     conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and~     availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there~     is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown~     to be efficacious and well tolerated in several African countries and is therefore such an~     option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and~     dihydroartemisinin-piperaquine is therefore needed.~      Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria~     will be informed of the study. If accepting and the child fulfil the inclusion criteria, the~     child will be randomised to treatment with either AL or DP. The treatment will be given~     supervised at the health centre in the morning and the evening on day 0, day 1, and day 2.~      At each visit and in the morning on day 3, the child will be examined, the mother asked for~     any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood~     sample will be taken for examination of malaria parasites. On day 0 samples for measurement~     of antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a~     subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number~     of leucocytes will also be taken.~      After having finished the treatment the children will be followed on day 7 and then once a~     week until day 42. At each visit the condition of the child will be examined and a~     bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper~     bloodsample will be collected for measurement of the drug concentration of if the child has~     recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will~     be examined.~      The result of the two treatments will be evaluated by comparing the number of children with~     recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections).~     This will be presented as adequate clinical and parasitological response rates PCR-corrected~     and PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and~     till day 42 will be compared. The concentration of the antimalarial drug in the blood~     samples taken at the visit before the re-parasitaemia will be capered to the concentrations~     in children without re-parasitaemia.~      Assuming a 20% loss to follow up a total of 346 children should be included. For the~     children included, health care and medications at Bandim Health Centre will be free during~     the study period but no other gifts or payments will be made.~      Results will be presented to the staff at the Bandim health centre and the ministry of~     Health and will be published in an international peer reviewed journal.~   "
103336|NCT01704495|"~     The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of~     AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)~     and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma~   "
103337|NCT01704482|"~     We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal~     dysfunction in patients with rheumatic valvular heart disease undergoing single valve~     replacement.~   "
103338|NCT01704469|"~     Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive~     sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but~     conflicting. Previous clinical studies mostly used experimental or non-standardized surgical~     stimuli to assess OIH. We therefore sought to certify a presence of OIH using a~     standardized, clinical pain stimuli in cancer patients receiving opioid therapy and~     opioid-naive patients.~   "
103339|NCT01704456|"~     This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment~     of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive~     Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with~     provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either~     eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week~     apart. The purpose of this study is to determine whether the 8-session MBCT intervention for~     PVD is more efficacious than an 8-session CBT intervention for decreasing women's pain~     intensity, sexual distress, catastrophizing and hypervigilance towards pain.~   "
103340|NCT01704443|"~     This study aims to test the efficacy of a 4-session intervention (Group psychoeducational~     treatment) using a randomized study design. Participants will be randomized in to 'immediate~     treatment' or 'waitlist control'. Women in the wait-list condition will receive the~     4-session IMPROVED treatment, just as women randomized to the experimental group, after the~     end of their wait-list period.~   "
103341|NCT01704430|"~     Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass)~     are at an increased risk of having abnormal inflammation in their body after surgery. Such~     inflammation can contribute to slower recovery from surgery, an increased risk of infection,~     an increased risk of damage to organs other than the heart, and a more complicated course.~      Prior research has suggested that using an oral protein supplement made of glutamine (an~     essential amino acid normally found in your body) can reduce the risk of inflammation,~     infection and the length of stay in hospital in patients who have suffered major trauma or a~     burn injury. The investigators believe reducing such inflammation after heart surgery may~     help promote recovery and reduce the risk of adverse events and complications.~      The purpose of this preliminary study is to see if oral glutamine supplementation after~     heart surgery is practical, and contributes to a reduction in inflammation. The oral~     glutamine proposed in this study is based on what has been previously studied and what is~     considered safe.~   "
103342|NCT01704417|"~     This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise~     on blood glucose in subjects with type 1 diabetes, who are treated with either insulin~     degludec (IDeg) or insulin glargine (IGlar).~   "
103343|NCT01704404|"~     This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects~     with Chronic Obstructive Pulmonary Disease (COPD).~   "
103344|NCT01704391|"~     Open elective abdominal aortic surgery is a high risk procedure involving clamping of the~     aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)~     causing lower limb ischaemia.~      These patients are often regarded as one entity in postoperative study settings. However,~     previous studies indicate that risk profiles, inflammatory activity, and haemodynamic~     capacity may differ between these groups. The first aim of this study was to evaluate~     postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising~     that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute~     dialysis than did patients with AOD.~      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)~     following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful~     in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of~     inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory~     response to aortic cross clamping may per se induce a rise in NGAL despite intact renal~     function. Therefore NGAL may not be a reliable marker of AKI after AAS.~      The second aim of this study is to describe the changes in NGAL after AAS in patients with~     and without postoperative dialysis-dependent AKI.~   "
103345|NCT01704378|"~     This trial is conducted in Europe. The aim of this trial investigate the the long-term~     safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.~   "
103346|NCT01704365|"~     The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein~     nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing~     potential.~   "
103347|NCT01704352|"~     Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases.~     Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive~     behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not~     been introduced to patients with bipolar disorder. The aim is to compare cognitive~     behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The~     investigators hypothesize that cognitive behavioral therapy will improve quality of sleep,~     stabilize minor mood variations and prevent new mood episodes in euthymic patients with~     bipolar disorder and insomnia.~   "
103348|NCT01704339|"~     Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being~     delivered to the tissues. It normally affects the hands and feet and can be very~     debilitating. It is particularly common and difficult to treat in patients with end stage~     renal failure~      Patients with renal failure are often high risk of any operative intervention which might~     help the pain. Often the only treatment options are painkillers. Unfortunately however, the~     commonly used painkillers, for example morphine, are known to cause worse side effects in~     patients with renal failure (drowsiness, confusion etc.~      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied~     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.~     It therefore should not have the systemic side effects of other drugs. It has been~     demonstrated to be beneficial in other painful conditions for example post-shingles pain and~     nerve pain from HIV. It has never been used for critical ischaemia before.~      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal~     failure and painful ischaemia. We will recruit 20 patients with painful ischaemia and treat~     them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain~     scores.~   "
103349|NCT01704326|"~     This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee~     System and is intended to evaluate the safety and effectiveness of the new device.~   "
103350|NCT01704313|"~     Patients with end-stage renal failure require dialysis to remove toxins from their blood.~     Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an~     AVF requires a short (~1hr) surgical procedure to join the artery and vein together.~      There are limited potential sites for fistula creation. Generally it is preferrable to~     utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude~     subsequent use of the wrist should the initial fistula fail. The small diameter of artery~     and vein at the wrist requires precise surgical technique.~      There are two potential techniques in common use for creating the arterio-venous anastomosis~     (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst~     there are theoretical advantages to the interrupted technique, it is uncertain if these~     translate clinically into better success of creating the fistula. The aim of this study is~     therefore to compare the clinical success of the two techniques.~   "
103351|NCT01704300|"~     The association between obesity and cardiovascular disease (CVD) has mostly been studied~     using broad endpoints or have focused on cause-specific mortality. The investigators aim to~     compare the effect of body mass index (BMI) on different types of initial presentation of~     CVD.~   "
103352|NCT01704287|"~     This study is being done to compare survival using pembrolizumab (MK-3475) or standard~     chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior~     therapy.~      Participants will be randomized to receive either low dose pembrolizumab, higher dose~     pembrolizumab or Investigator-choice chemotherapy. The pembrolizumab dose will be blinded to~     Investigators and participants. With Amendment 03, all ongoing pembrolizumab participants~     will be treated with open-label, fixed dose pembrolizumab 200 mg every 3 weeks (Q3W),~     instead of weight-based dosing of pembrolizumab.~      The randomization to either pembrolizumab or Investigator choice chemotherapy will be~     conducted in open-label fashion. The four standard chemotherapy choices are carboplatin +~     paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. Participants on standard~     chemotherapy who experience disease progression may be eligible to crossover to treatment~     with pembrolizumab provided they meet protocol-specified requirements for crossover.~     Crossover participants will be treated with open-label, fixed dose pembrolizumab 200 mg Q3W.~   "
103353|NCT01704274|"~     Prostate cancer is the most commonly diagnosed cancer in men in Canada. Over 30% of men over~     the age of fifty have histological evidence of prostate cancer on biopsy. Despite the stage~     migration afforded by early detection with serum prostate specific antigen (PSA) testing and~     an apparent trend toward improved survival over the past several years, prostate cancer~     remains a significant cause of morbidity and mortality. Biochemical failure after primary~     therapy (surgery or radiation) remains a significant health care burden and strategies to~     delay clinical prostate cancer progression and prolong the interval from treatment failure~     to systemic therapy would be of significant clinical benefit for those men suffering from a~     finding of PSA recurrence.~      PSA is widely accepted as the most useful prognostic marker of prostate cancer progression,~     particularly after primary therapy with radical surgery or radiation. 5 Despite improved~     cancer control rates with definitive management of early stage prostate cancer, a PSA~     recurrence is unfortunately a common occurrence (25-50%) in most large case series.~      Microenvironmental factors have been demonstrated to play a pivotal role in the selection of~     neoplastic cell subpopulations expressing more malignant phenotypes and contributing to the~     progression of localized and metastatic disease. Very low levels of O2 (< 10 mmHg) has been~     well described in many solid tumours (including prostate cancer) and the extent of hypoxia~     has been demonstrated to represent an independent marker of a poor prognosis for patients~     with various types of cancers. Tumour hypoxia contributes to numerous adaptive phenotypes~     including increased invasion and metastasis, as well as evasion of immune cell surveillance~     increased resistance to radiotherapy and chemotherapy. Although cellular adaptive responses~     to hypoxia are likely mediated by various mechanisms, our previous preclinical studies~     suggest that decreased nitric oxide (NO)-dependent signalling plays a significant role in~     this progression of a malignant phenotype.~   "
103354|NCT01704261|"~     This study will examine the safety and efficacy of the addition of omarigliptin in~     participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and~     glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with~     omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition~     of placebo.~   "
103355|NCT01704248|"~     To investigate if the Eye Drop Guide more effective than carefully instructed routine~     technique for chronic glaucoma patients to self-instill eye drops.~      And what factors are associated with the failure of self-instillation eye drops with the Eye~     Drop Guide?~   "
103356|NCT01704235|"~     The purpose of this protocol is to understand the extent of symptom perception and~     preventive care-seeking among Vietnamese American women and their impact on cervical cancer~     screening from the perspectives and experiences of key informants including primary health~     care providers and Vietnamese American women (VAW, foreign-born and United States-born).~     With this information, the investigators can better understand how to promote cervical~     cancer screening in the Vietnamese community.~   "
103360|NCT01704183|"~     The purpose of this study is to study the effect of fingolimod on cardiac autonomic~     regulation in patients with relapse-remitting multiple sclerosis.~      This will be done by measuring heart rate variability from the 24-hour Holter recording and~     myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.~      The fingolimod treatment is prescribed according to the accepted drug label.~   "
103361|NCT01704170|"~     This study is a prospective, multi-center trial wherein each included subject will receive~     the experimental externally focused ultrasound renal denervation therapy. It will be~     conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and~     have signed the informed consent form. Safety is the primary endpoint of this study and will~     be assessed by incidence and evaluation of any serious adverse effects associated with the~     investigational procedure through the 52-week evaluation. Clinical utility is the secondary~     endpoint of this study and will be evaluated by assessing pre and post therapy systolic and~     diastolic blood pressure.~   "
103362|NCT01704157|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III device for temporary relief of pain.~   "
103363|NCT01704144|"~     Efavirenz is an essential component of HIV treatment in children aged 3 years or older on~     anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during~     anti-TB treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the~     drug metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of~     efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between~     the HIV and anti-TB drugs also vary between individuals based on genetic factors. This study~     will investigate the effects of anti-TB treatment, as well as drug-gene interactions on the~     blood concentrations of efavirenz in children with HIV and TB infections. Such data could~     enhance optimization of efavirenz dosage or selection of alternate regimens in some~     children.~   "
103364|NCT01704131|"~     Levosimendan is a drug used in patients with heart failure and has several advantages over~     other heart failure drugs. A lot of research has been done with Levosimendan in Adults, and~     the way the body handles the drug (pharmacokinetics) and responds to the drug~     (pharmacodynamics) are well established. But, in children this information is lacking~     despite the fact that Levosimendan is increasingly used in children of all ages. The~     investigators aim to describe which Levosimendan dose leads to which drug levels in children~     of different ages.~   "
103365|NCT01704118|"~     Objective of this prospective, randomized and controlled study is to compare the~     performances of recently-released size 1 I-gel and size 1 PLMA proven to be superior to~     classical LMA with prospective studies. In this study, primer endpoint was value of airway~     leak pressure and secondary insertion time, insertion success and conditions, initial airway~     quality, hemodynamic parameters, fiberoptic view and complications will be assessed.~   "
103366|NCT01704105|"~     The purpose of this study is to measure the independent and combined effects of~     interventions that improve sanitation, water quality, handwashing, and nutrition on child~     health and development in the first years of life.~   "
103367|NCT01704092|"~     The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in~     the setting of off-pump coronary bypass procedure and can provide benefits to cardiac~     function and cognitive performance on the ground of the dexmedetomidine's characteristics.~   "
103368|NCT01704079|"~     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact~     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and~     tolerability of CTAP101 will also be evaluated~   "
103369|NCT01704066|"~     The original American-European Consensus Conference (AECC) definition of Acute Respiratory~     Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on~     frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR~     using this definition among intensivists and radiologists.~      As a result, the newly published Berlin definition of ARDS specified that the CXR criterion~     should include bilateral opacities consistent with pulmonary edema not fully explained by~     effusions, lobar/lung collapse, or nodules/masses on CXR.~      In order to improve inter-observer agreement, the panel have also developed a set of CXRs~     judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.~      The objective of this study is to investigate the impact of this training set on~     inter-observer reliability in applying the radiographic definition for ARDS.~   "
103370|NCT01704053|"~     The purpose of this study is determine whether point of care coagulation testing is able to~     map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used~     as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer~     (Multiplate).~   "
103371|NCT01704040|"~     The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy~     (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants~     before and after intranasal (into the nose) inoculation with human rhinovirus type 16~     (HRV-16).~   "
103372|NCT01704027|"~     The purpose of this study is to evaluate the incidence of urinary and rectal acute side~     effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous~     integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with~     high risk localized prostate cancer~   "
103373|NCT01704014|"~     Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during~     cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator~     muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS.~     However the prevalence of IFIS in Korean population is not reported. The purpose of this~     study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris~     anatomical change in Korean patients taking α1-ARA.~   "
103374|NCT01704001|"~     To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in~     patients with Disseminated Intravascular Coagulation.~      To investigate the safety of ART-123 in patients with Disseminated Intravascular~     Coagulation.~   "
103375|NCT01703988|"~     This study will test the safety, tolerability, and pharmacokinetics of escalating doses of~     ISIS-SMNRx administered into the spinal fluid either two or three times over the duration of~     the trial, in patients with Spinal Muscular Atrophy.~   "
116821|NCT01526915|"~     The main objective of our study is to assess, after tooth extraction, the efficacity of PRF~     in the prevention of healing delay and of jawbone osteochemonecrosis induced by~     bisphosphonates~   "
103376|NCT01703975|"~     Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of~     medical health care providers. However, training costs are considerable and may be optimized~     using interventions to improve learning. The aim of this study is to compare the effects of~     training in pairs versus training alone on an VR ultrasound simulator.~      Methods: 30 medical students in their final year are randomized to either training in pairs~     or training alone. All participants are trained for two hours. Subsequently, all students~     are assessed on ultrasound performance on real patients in an ambulatory setting.~     Performance is assessed using a rating scale that has been validated in a previous study by~     two blinded assessors.~   "
103377|NCT01703962|"~     The recurrent mutation IDH1Arg132His leads to the cellular accumulation of~     D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost~     specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.~      The main objective is to identify the patients with IDH1 mutated glioma by three~     complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA),~     biochemical (2-HG dosage in the urine of patients) and radiological (2-HG~   "
103378|NCT01703949|"~     This pilot clinical trial studies brentuximab vedotin in treating patients with CD30+~     lymphoma has come base after a period of improvement or does not respond to treatment.~     Biological therapies, such as brentuximab vedotin, may stimulate the immune system in~     different ways and stop cancer cells from growing.~   "
103379|NCT01703936|"~     This project is an evaluation of an agricultural training and resettlement program for~     high-risk young adults in Liberia, especially poorly integrated male ex-combatants. The~     primary aim is to see to what extent an intensive economic and life skills intervention can~     rehabilitate high-risk individuals and reduce aggression and armed violence.~   "
103380|NCT01703923|"~     The purpose of this study is to determine the antitussive effect size and dose response of~     FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability~     of FP01 lozenges in subjects with chronic cough.~   "
103381|NCT01703910|"~     The purpose of this study is to assess the feasibility of selecting personalized therapies~     for colon cancer patients who have failed standard treatments, using a new methodology based~     on the determination of a profile of chemosensitivity by comprehensive genetic expression~     analysis from tumor samples.~   "
103382|NCT01703897|"~     The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in~     obese patients before and during anesthesia.~   "
103383|NCT01703884|"~     The program's overall objective is to assess the impact of a package of interventions aimed~     at reducing malaria-related mortality and morbidity in pregnant women and newborns by~     ensuring access to a package of interventions designed to optimise the detection and~     treatment of malaria during pregnancy as well as improving the early detection and treatment~     of malaria during the third trimester.~   "
103384|NCT01702883|"~     The purpose of this study is to evaluate whether participation in an Internet-based~     intervention helps improve medication use.~   "
103385|NCT01702870|"~     A prospective observational study to determine the effectiveness of magnetic resonance (MR)~     imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.~   "
103386|NCT01702857|"~     This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV~     vaccine in a predominantly dengue-primed adult population. The study is designed to afford a~     first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine~     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or~     AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate~     vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of~     purified virus antigen per each of the four DENV types. Additionally, the study will~     evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus~     antigen per each of the four DENV types. The control group will receive a saline placebo.~     All experimental vaccinations will be administered according to a 2-dose schedule, 28 days~     apart. There is a parallel FTiH study that is conducted in the United States in a~     dengue-naive population using the same investigational vaccines.~   "
103387|NCT01702844|"~     The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel~     for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small~     cell lung cancer (NSCLC)~   "
103388|NCT01702831|"~     A number of strategies have been proposed to improve the outcome of ASCT. The three main~     strategies are to incorporate novel agents into the induction regimen, using maintenance~     therapy following ASCT and the final strategy is to enhance conditioning regimens.~      Investigators would like to explore all these three strategies in this study: Investigators~     propose to take patients who have had standard novel agent (bortezomib) based induction~     regimens into this study and then use a dose-adjusted combination of busulfan and melphalan~     as conditioning regimen and finally Investigators would like to incorporate lenalidomide~     maintenance post ASCT until disease progression.~   "
103389|NCT01702818|"~     Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone~     activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although~     DHEA is a precursor of testosterone it has other actions including involvement in the stress~     system. It is also linked to mood. This study focuses on measures of childhood stress,~     current mood and salivary and nail stress hormones, in women with and without HSDD. We~     hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress~     response system involving the brain, pituitary and adrenal glands where DHEA is produced.~   "
103390|NCT01702805|"~     The objective of the TOP trial is to determine whether higher hemoglobin thresholds for~     transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the~     primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months~     of age, using standardized assessments by Bayley.~   "
103391|NCT01702792|"~     This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to~     determine the ability to generate human hybridomas from lymph nodes draining an autologous~     tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific~     antibodies.~   "
103392|NCT01702779|"~     This is a prospective, randomized clinical multicentric study in ICU (Intensive Care~     University)during weaning from mechanical ventilation.~   "
103393|NCT01702766|"~     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common~     nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be~     defined as infections which develop more than 48 hours after admission and they are not~     present or incubating on admission~      This study is a prospective, randomized, double blind, placebo- controlled parallel study in~     children hospitalized at Children's hospital Zagreb.~      The study will investigate the effect of supplementation with the probiotic strain~     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and~     respiratory infections.~      The test product is a sachet containing 1 gram of powder. The test product will contain~     minimum 1 billion CFU (colony forming units) probiotic per serving.~      The placebo product is an identical product except for the absence of probiotics.~      The study includes an intervention period lasting the length of the hospital stay.~      The study product will be consumed daily in the morning together with breakfast.~      The consumption of the study products will be taken under the surveillance of the physician.~      Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of~     infections will be analyzed based on the information recorded in the CRF.~   "
103394|NCT01702753|"~     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common~     infections (gastrointestinal and respiratory) in healthy children who attend day care centre~      This study is a prospective, randomized, double blind, placebo- controlled parallel study in~     healthy children attending day care centers.~      The study will investigate the effect of supplementation with the probiotic strain~     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and~     respiratory infections and absence from day care due to infections.~      The test product is a sachet containing 1 gram of powder. The test product will contain~     minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product~     is an identical product except for the absence of probiotics.~      The study includes 3 months (90 days) of intervention period. The study product will be~     consumed daily in the evening together with a meal.~      The consumption of the study products will be taken under the surveillance of the parents.~      During the entire intervention period the subjects are not allowed to consume any probiotic~     products other than the study products supplied to them by the study personnel.~      Data on infections will be recorded in a diary, filled in and administered by the parents~     and diary recorded by referring physician (on-call log).~      All infections are to be diagnosed by the local physician. The incidence of infections will~     be analyzed based on the information recorded in the diaries (parent's & physician's).~   "
103395|NCT01702740|"~     The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the~     action of a drug in the body over a period of time) of multiple intravenous (IV)~     administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and~     systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the~     pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of~     action), immune response, and clinical response.~   "
103396|NCT01702727|"~     The study aims to determine whether 30 minutes of treatment playing an interactive computer~     game weekly for 6 weeks, improves visual acuity. The game has been specially configured to~     ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses~     which manipulate the image seen by each eye in order to provide more information to the~     amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM~     technology, play the computer game but without the I-BiTTM technology, or watch a DVD using~     the I-BiTTM technology.~   "
103397|NCT01702714|"~     This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an~     expansion cohort will determine the recommended Phase II dose and schedule to investigate~     safety, tolerability, and activity of RO5083945 in combination with cisplatin and~     gemcitabine or carboplatin and paclitaxel in patients with advanced or recurrent non-small~     cell lung cancer of squamous histology who have not received prior chemotherapy for the~     metastatic disease. Cohorts of patients will receive escalating doses of RO5083945 in~     combination with up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel.~     Anticipated time on study treatment is until disease progression or unacceptable toxicity~     occurs.~   "
103398|NCT01702701|"~     This study will compare response to treatment of Eosinophilic Esophagitis with montelukast~     vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally~     effective in treating symptoms and histology of EoE when compared to fluticasone. The study~     will be conducted at multiple sites with Medical College of Wisconsin as the coordinating~     site. After identification and recruitment all patients will be randomized (provider~     blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid.~     Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire.~     They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.~   "
103399|NCT01702688|"~     Thank you for your interest in our Blood Pressure Research Study. The American Heart~     Association is sponsoring us to investigate why patients develop high blood pressure,~     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our~     research program. The first part is a screening visit. At this visit you will be given a~     brief physical exam and will be asked questions concerning your medical history. During the~     same visit you will have your blood drawn for routine screening and genetic testing. You~     will also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, we will perform physiological tests after you~     are placed on a low salt diet and again after you are placed on a higher salt diet. If you~     are on blood pressure medication, it may be necessary to discontinue taking your present~     medication for up to three months before beginning the study. Patients discontinuing their~     current blood pressure medication may be placed on a different blood pressure medication~     during this 'washout' period if necessary to maintain blood pressure at pre-study levels.~      Once your blood pressure medications are discontinued, you will be closely monitored. If you~     do not own a home blood pressure monitor, we will provide one for you to use during the~     study so that you can keep a daily record of your blood pressure readings. We will ask you~     to call us every three days to report your blood pressure readings. After you have stopped~     taking your medication, dietitians at the hospital will make you low salt meals to eat at~     home for about seven days. On the last day of the low salt diet, you will be asked to begin~     a 24-hour urine collection that you will bring with you when you are admitted to the~     hospital that evening. That morning, you will be required to come to the Center for Clinical~     Investigations (CCI) at Brigham and Women's Hospital for a one-hour test to check if your~     body is in the correct salt balance.~      You will return that evening to the CCI where you will be admitted for your study that will~     occur the next morning. On the morning of your low salt study, we will collect some blood~     samples. We will also take ultrasound pictures of your heart to see how salt and hormones~     affect the way your heart and blood vessels functions. These tests will last approximately 5~     hours and you will be discharged around 2:00 PM. For the next 5-7 days, you will be placed~     on a liberal salt diet. During this diet period, you will eat all your own food, but we will~     give you some supplements to add to your meals. After 5-7 days on your liberal salt diet, on~     the morning of your second admission to the hospital, you will be asked to begin a final~     24-hour urine collection. That morning, you will again be required to come to the CCI for a~     blood test, and you will return later that evening to the inpatient CCI where you will be~     admitted for your final overnight study. The same study that was done for the low salt diet~     will be repeated for the liberal salt study. You will be discharged at around 2:00 p.m.~     These studies will help to determine if you are salt-sensitive. In addition, we hope to~     learn more about the hormones that regulate your blood pressure and the genes responsible~     for regulating those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. We can also provide clinically relevant~     information to you.~   "
103400|NCT01702675|"~     The purpose of this study is evaluate the safety and tolerability parameters regarding the~     new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and~     multiple doses of the new drug.~   "
103401|NCT01703871|"~     Office Hysteroscopy is associated with a level of anxiety that could condition tolerability~     of the procedure by the patient.~      The aim of this study is to evaluate the impact of music on anxiety state, expected and~     received pain by patients during office hysteroscopy.~   "
103402|NCT01703858|"~     The objective of the trial is to investigate the relative bioavailability, influence of~     pantoprazole coadministration and food effect of different oral formulations of BI 113608 in~     healthy male subjects~   "
103403|NCT01703845|"~     The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol~     fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3~     weeks once daily treatment in Japanese patients with COPD.~   "
103404|NCT01703832|"~     The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an~     experimental stress test called the Trier Social Stress Test~   "
103405|NCT01703819|"~     The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an~     experimental stress test called the Trier Social Stress Test~   "
103963|NCT01696266|"~     This study is conducted in Europe. The aim of the study is to gather information about~     hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus.~     The study is both retrospective and prospective.~   "
103406|NCT01703806|"~     The timing of surgical intervention in asymptomatic patients with severe degenerative mitral~     regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in~     prospective, observational studies, whereas a watchful waiting strategy seemed to be safe~     and effective in the other prospective study. The consensus guidelines for the performance~     of early surgery in asymptomatic patients with severe MR are different, reflecting~     controversy. Clinical outcome in asymptomatic patients with MR is poorly defined and it is~     important to identify high-risk patients in whom early surgery may be warranted. Thus, the~     investigators try to compare long-term outcomes of early surgery with those of a~     conventional-treatment strategy in a large prospective cohort of asymptomatic patients with~     severe degenerative MR using a propensity analysis, and to identify high-risk subgroups to~     whom early surgery is more beneficial.~   "
103407|NCT01703793|"~     The purpose of this study is to determine if two test products are safe and effective in the~     treatment of seborrheic dermatitis.~   "
103408|NCT01703780|"~     Hypertension is still one of the major preventable risk factor for cardiovascular as well as~     cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and~     renal impairment. Despite knowledge on hypertension and the availability of effective~     antihypertensive medications have progressed dramatically in recent years, the rate of~     uncontrolled hypertension ( reached 90%) remains high in China[1]. Among those with~     uncontrolled hypertension，it has been reported that 8.9% in all individuals with~     hypertension, and 12.8% in the hypertensive drug-treated population[2] are attributed to~     resistant hypertension. Resistant hypertension has been defined by AHA as high blood~     pressure (BP) in spite of appropriate lifestyle interventions and treatment of three or more~     different types of antihypertensive drugs at optimal dose, including at least one~     diuretics[3,4] or achieving adequate BP control with optimal doses of 4 or more~     antihypertensive drugs.~      At present, not many specifically designed prospective researches concerning resistant~     hypertension are available. The prevalence of resistant hypertension is not well established~     and most knowledge about resistant hypertension derives from cross-sectional analyses and~     clinical trials. The patients with resistant hypertension have been expected to have server~     target damage, and worse prognosis than those who are non-resistant, but not well~     established either in the literature[2].~      The purpose of this study is to determine the prevalence of resistant hypertension~     ascertained with systemic investigation and optimal treatment with antihypertensive drugs in~     community populations and clinic as well as the prognosis among patients with resistant~     hypertension compared with those who are non-resistant.~   "
103409|NCT01703767|"~     The purpose of this study is to investigate Gulf War 1 Veteran (GW1V) patient perceptions~     of, and satisfaction with, their VA primary care treatment, and physician effectiveness in~     delivering improved point of service, in the Primary Care Clinics at the Veterans~     Administration (VA) Salt Lake City Health Care System.~   "
103410|NCT01703754|"~     Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with~     accessible lesions.~      Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time~     point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with~     chemotherapy (palifosfamide) is safe and efficacious.~   "
103411|NCT01703741|"~     This is a multicenter extension trial in adult hypogonadal males. The purpose of this study~     is to evaluate the safety of testosterone gel delivered using an applicator over an extended~     period of time.~   "
103412|NCT01703728|"~     Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian~     stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe~     the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age~     treated with HP-hMG.~   "
103413|NCT01703715|"~     Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended~     length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration.~     One of the biggest problems for many people with regard to getting a drink is easy,~     independent access - if they can't reach the jug/cup without a struggle then they often will~     go thirsty and potentially become dehydrated.~      The purpose of this study is to investigate the impact of dehydration on outcome in patients~     65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour,~     independently accessible fluids on reducing dehydration as well as improving patient~     experience.~      We hypothesise that patients who are dehydration will take longer to recover from illness~     and stay in hospital for longer periods.~   "
103414|NCT01703702|"~     This study is designed to determine the effectiveness of florbetapir (18F) in changing~     patient management and to evaluate the association between scan status and cognitive~     decline.~   "
103415|NCT01703689|"~     Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality~     indicators is not well-established.~      The main objective: The main purpose of the IQUARE study was to examine the impact of two~     types of audit and feedback interventions on NH quality indicators and on residents~     dependence levels in a 18-month follow-up.~      Study hypothesis: We hypothesised that audit and feedback associated to educational and~     professional supportive interventions are more efficacy in improving NH quality indicators~     than audit and feedback only.~      Secondary objectives: Investigate the impact of the interventions on~        1. Residents:~             -  Functional decline rate~             -  Drug prescriptions (quantity and quality)~             -  Prevalence of adverse health outcomes (e.g., falls)~        2. NHs:~             -  Planning and implementation of therapeutic measures~   "
103429|NCT01703507|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with whole brain radiation therapy or stereotactic radiosurgery in treating patients with~     melanoma with brain metastases. Monoclonal antibodies, such as ipilimumab, can block tumor~     growth in different ways. Some block the ability of the tumor to grow and spread. Others~     find Tumor cells and help kill them or carry tumor-killing substances to them. Radiation~     therapy, such uses high-energy x-rays and other types of radiation to kill tumor cells.~     Giving radiation therapy in different ways may kill more tumor cells. Giving ipilimumab~     together with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor~     cells.~   "
103891|NCT01697215|"~     To evaluate the ability of the SonarMed AirWave to provide clinicians with information that~     enables them to confirm continuous proper placement of the endotracheal tube. This initial~     study is prospective, observational, looking at CXR results, and comparing those to AirWave~     system output data.~   "
103416|NCT01703676|"~     This study will elucidate how the parental origin of the X-chromosome influences health~     status as well as metabolic fate in Klinefelter patients. Epigenetics and~     transcriptome-research will be directly linked to the metabolic and inflammatory pattern of~     actual patients to improve care for them. The Klinefelter Syndrome is one of the most common~     genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly~     active and disturbs a normal male development. Testosterone deficiency in form of primary~     hypogonadism is a common feature in these men. Such a condition promotes clinically relevant~     metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2~     (insulin resis-tance), cardiovascular disease as well as infertility. However, the variety~     of pathologies is pro-nounced between patients and low testosterone concentrations cannot~     fully explain the wide scope of pathologies in these men. Some patients become clinically~     obvious during puberty and adoles-cence, some in their thirties or later and all exhibit a~     huge variation in phenotype. Switching on and off of specific genes on the X-chromosome is~     differential, depending on the origin either from the maternal or paternal side. Hence, an~     influence on the clinical picture is hypothesised. Thus, key targets are clarification of~     the parental origin of the supernumerary X chromosome and elucidation of methylation and~     expression profile of pivotal X-chromosomal genes. These will be related to clinically~     relevant metabolic and inflammatory patterns as well as fertility to identify individual~     risks as well as treatment strategies for Klinefelter patients.~   "
103417|NCT01703663|"~     Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP)~     therapy on sleep apnea severity among patients with recent ischemic stroke.~      Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea,~     as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a~     control night.~      Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation~     with nasal EPAP therapy compared with a control night.~   "
103418|NCT01703650|"~     The purpose of this study is~        1. to determine whether the perfusion parameters in the normal pancreas and the pancreas~          cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT~        2. to determine whether initial perfusion parameters as well as perfusion parameter change~          in pancreas adenocarcinoma before and after chemotherapy are different between~          chemotherapy response group (CR, PR according to RECIST 1.1) and non response group~          (SD, PD according to RECIST 1.1).~   "
103419|NCT01703637|"~     The purpose of this study is to explore the differences in efficacy and safety of~     sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating~     type 2 diabetes mellitus.~   "
103420|NCT01703624|"~     This is an investigation of the beneficial effects, tolerability and safety of a range of~     single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female~     patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a~     long term and progressive disease of the lungs, generally caused by cigarette smoking, but~     other factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful~     in dilating the constricted airways of such patients, with a duration of action variously~     described as being between 12 and 24 hours.~      This study will investigate how well tolerated and safe this medication is at a range of~     doses. It will also help in the selection of a suitable dose for larger and repeat dose~     studies, based on measures of lung response. It will also help to determine how often the~     medication should be given; twice daily, or once daily.~      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of~     age. Patients will be medically assessed before participation to ensure their suitability.~     The study will take place in one centre in the UK over five sessions; at each session one~     dose (2 puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple~     inhaler device. Neither staff nor patients will know which dose, or if placebo, is being~     taken. Lung function will be measured for up to 26 hours after the administration of each~     dose using standard spirometry equipment. Blood samples will be taken over a 24-hour period~     to check the blood levels of GB. There will be a period of about a week between each dosing~     session. Patients will be medically reviewed after the study to confirm that no untoward~     effects are present.~   "
103421|NCT01703611|"~     A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians~     in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).~   "
103422|NCT01703598|"~     The purpose of this study is to determine whether performing deep brain stimulation surgery~     for Parkinson's disease using intraoperative imaging and frameless stereotaxis is~     noninferior to using frame-based stereotaxy and microelectrode recording.~   "
103423|NCT01703585|"~     This is a feasibility study to look for genetic alterations in tissue and blood samples that~     may be useful in determining what treatments may be useful in the patient's cancer care.~   "
103424|NCT01703572|"~     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects~     with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase~     and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,~     biomarkers, and efficacy.~   "
103425|NCT01703559|"~     Night vision complaints such as glare, starburst and halo are often a result of peripheral~     corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic~     conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light~     scatter in dim light situations.~   "
103426|NCT01703546|"~     The purpose of this research study is to evaluate whether combining laparoscopic adjustable~     gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks~     in the large curve of the stomach with stitches) to lap-band surgery alone will result in a~     greater loss of excess weight over time. We anticipate that the average percent of excess~     body weight loss for study subjects will exceed 29% at 12 months.~   "
103427|NCT01703533|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Rett Syndrome in adolescent and adult females.~   "
103428|NCT01703520|"~     The objective of this study is to investigate the potential association between finasteride~     (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden,~     Finland, and Norway from data in national registries. The primary hypothesis of this study~     is that the previously reported increased incidence of male breast cancer among finasteride~     users is explained by confounding factors.~   "
103430|NCT01703494|"~     There has been an alarming increase in the incidence and severity of Clostridium difficile~     infection (CDI) in North America over the past decade. Relapsing infection is a common~     problem in patients treated for CDI, often requiring prolonged and expensive courses of oral~     vancomycin with limited alternative treatment options. This study will determine if fecal~     microbiota transplantation, which involves administering fecal flora from a healthy stool~     donor to a patient with relapsing CDI, is an effective and safe treatment.~   "
103431|NCT01703481|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the~     body does to a drug), and pharmacodynamics (study of what a drug does to the body) of~     JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in~     adult participants with advanced or refractory solid tumors or lymphoma.~   "
103432|NCT01703468|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Oxcarbazepine Suspension 600 mg under fed conditions~   "
103433|NCT01703455|"~     This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in~     patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be~     conducted with the primary aim to determine the response rate (CR+PR) according to the~     RECIST criteria. Response rate according to CHOI criteria, correlation between CHOI criteria~     and outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary~     objectives.~   "
103434|NCT01703442|"~     A single-center prospective observational study. This study examines urine flow and~     haemodynamic parameters during abdominal surgery and analyses the association to~     postoperative renal function and markers and to postoperative clinical outcome.~      Primary hypothesis:~      • Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are~     phases of temporary anuria.~      Secondary hypothesis:~        -  Perioperative anuric phases are directly associated to the postoperative increase of~          NGAL (neutrophil gelatinase-associated lipocalin) and creatinine~        -  Perioperative renal dysfunction is directly associated to postoperative complications~          and functional recovery of patients~        -  A response of urine flow to a standardized postoperative diuretic bolus can identify~          patients who benefit from a pharmaceutical fluid mobilization~        -  Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the~          methods for the measurement of stroke volume of the heart differ~   "
103435|NCT01703429|"~     This is a prospective, observational study designed to describe disease progression, symptom~     change, quality of life, diet and lifestyle habits, and frequency of adverse events among~     patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM).~     In addition to describing the patterns of CAM use, this study will also identify and~     describe the positive deviants, those individuals with the highest quality of life and least~     amount of disease activity. Positive deviants will be compared to controls in order to~     describe medication, diet, and lifestyle patterns associated with a lack of MS disease~     progression and high quality of life.~   "
103436|NCT01703416|"~     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily~     clinical practice the possible correlation between patient perception of the ability to~     perform morning activities and the physician's assessment during a regular physical exam in~     patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.~   "
103437|NCT01703403|"~     Low back pain is a common health issue in elderly population. According to the statistics,~     more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain~     includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain,~     spondylolisthesis…etc. In addition to drugs and surgery, physical therapy is an alternative~     choice for conservative treatment. Therefore, in this study, the investigators propose to~     analyze the physical examination, diagnostic methods, X ray, physical therapy records,~     physical therapy methods and clinical outcomes in patients with the diagnosis including~     lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at~     National Taiwan University Hospital and received rehabilitation at the Physical Therapy~     Center in recent ten years.~   "
103438|NCT01703390|"~     This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene~     expression status suggests better clinical results from historical experience in metastatic~     colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or~     FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%.~     Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1~     treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and~     cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated~     with 6 cycles of one of the following regimens chosen for optimization based on patient~     characteristics (primary treatment phase). Patients with ERCC-1 < 1.7 relative gene~     expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6~     in combination with Cetuximab. Patients with ERCC-1 gene expression > 1.7 relative gene~     expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with~     FOLFIRI in combination with Cetuximab.~   "
103439|NCT01703377|"~     A major advantage of understanding a neural control scheme is able to simultaneously perform~     multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of~     motor redundancy. The present study aims to investigate this hypothesis further by examining~     the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural~     control when the arms performing targeting task simultaneously in standing. Subjects~     (Younger group: 20~35 years old; Elder group: 60~85 years old) will execute a targeting task~     with and without an additional ball-balancing task in standing with free joint motions and~     with restricted joint motions. The investigators expect to recruit 50 subjects for each~     group. Analyses of joint configuration variance on the stability of the center of mass (COM)~     position and the hand path will be performed using the UCM method of variance analysis. This~     method partitions joint configuration variance into one component consistent with the use of~     motor abundance and a component that leads to COM position or hand path variability.~     Furthermore, the differences between the younger group and the elder group will be~     evaluated.~   "
103730|NCT01699360|"~     The aim of this study is to evaluate the potential of endogenous cortisol and cortisone~     metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal~     transplant recipients. If the blood concentrations of immunosuppressants can be predicted~     successfully, this new probe may take place of current drug monitoring post transplantation.~   "
103440|NCT01703364|"~     This is a trial in patients with previously untreated CLL. Eligible patients will receive~     Lenalidomide with a backbone of Fludarabine and Rituximab for 6 therapy cycles. Lenalidomide~     will be increased by dose steps of 5 mg every cycle in the absence of limiting toxicity. If~     limiting toxicity ensues the patients will be treated with last tolerable dose for the~     remainder of the 6 treatment cycles.~      The first 5 patients will start with dose level 5 mg Lenalidomide and further escalating~     dose. After the fifth patient is included in the study, enrolment will be interrupted until~     this patient has finished his first treatment cycle. A safety board will evaluate the~     toxicities of the first 5 patients. If there are more than 2 patients experiencing a dose~     limiting toxicity (DLT) in the first treatment cycle, the starting dose will not be~     escalated and further 5 patients will be enrolled with a starting dose of 5 mg Lenalidomide.~     If only 2 or less patients experience a DLT in the first treatment cycle, the next 5~     patients will start the treatment with 10 mg Lenalidomide.~      The rational for the higher starting doses stems from the lack of tumor lysis or tumor flare~     toxicity in this combination on the one hand and from the observation that the very slow~     escalation from 2,5 mg on led to a lack of efficacy in monotherapy trials due to early~     progression in a relevant number of cases. The increase of the Lenalidomide dosage should~     result in an increased efficacy especially at the beginning and a higher cumulative dose of~     Lenalidomide.~      The identification of patients intolerant to Lenalidomide by immunophenotyping of the T~     cells for validation is also part of this trial, because intolerance seems to be not dose~     dependent but may be caused by T cell activation. Therefore, early identification of~     patients intolerant to this form of modern immunochemotherapy and establishing efficient~     Lenalidomide based combination therapy is an important part of improvement of current CLL~     treatment.~   "
103441|NCT01703351|"~     Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy~     and it has reduced the operative morbidities and mortalities. However, thoracoscopic~     lobectomy also results in operative acute pain and the incidence of chronic pain after~     thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,~     torque at trocar and working window by operator, and compression of intercostal nerves have~     been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous~     patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,~     sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic~     delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the~     effective dose of analgesics could not deliver to patients. In contrast to IV PCA,~     continuous paravertebral infusion of local anesthetics thorough catheter below the parietal~     pleura might reduce the side effects of IV PCA and control the operative pain effectively.~     In this study, we investigate the effectiveness of continuous paravertebral infusion of~     local anesthetics thorough catheter below the parietal pleura for 60 hours after operation~     competed to IV PCA.~   "
103442|NCT01703338|"~     Lumbar fusion has been widely used for spinal disorders when conservative treatment has~     failed. However, a number of studies have reported that the rate of re-operation is high for~     lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at~     the surgery site can cause weakness and pain. After fusion, the range of motion is~     constrained at the fused spine and might facilitate compensative movement of the adjacent~     levels and increase degeneration rate of the spine.~      Evidence has shown that core muscles play an important role to stabilize and support the~     spine. Whether core stability exercise can enhance spinal stability after lumbar fusion~     surgery remains unclear. Therefore, the overall goal of this proposed research is to~     investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators~     will explore this issue hierarchically and systematically in 3-year duration.~   "
103443|NCT01703325|"~     Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects~     both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a~     defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,~     discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of~     psoriatic nails is using topical high- potent steroids however topical steroids are limited~     their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of~     such a treatment can lead to skin atrophy and report in the case of Disappearing digits.~     Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory~     results without any serious permanent adverse effects. At present, there is no comparison~     study between intralesional steroid and ultrapotent topical steroid for the treatment of~     psoriatic nails.~      The purpose of the study is to evaluate the efficacy and safety of intralesional~     triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.~   "
103444|NCT01703312|"~     This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with~     allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen~     that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1)~     at 12 weeks compared to baseline will be evaluated.~   "
103445|NCT01703299|"~     The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more~     common due to the increased prevalence in the hospital and community of extended spectrum~     β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are~     resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure~     towards emergence of strains which are also resistant to carbapenems, placing patients in a~     catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of~     emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake~     preventive measures to preserve their effectiveness. The aim of the study is to evaluate and~     describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.~   "
103446|NCT01703286|"~     The general aim of the present study is to investigate the impact of 4 weeks treatment with~     linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the~     current trial this effect of linagliptin treatment on endothelial function will be compared~     against both the sulfonylurea glimepiride and against placebo, which has not been tested in~     a trial before; as also is the case for other DPP-4 inhibitors.~      Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second~     most used oral antidiabetic drug class.~   "
103484|NCT01702571|"~     This two-cohort, open-label, multicenter study will assess the safety, efficacy and~     tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced~     breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and~     chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general~     participant population; Cohort 2 will include only Asian participants.~   "
103485|NCT01702558|"~     This multicenter study will assess the maximum tolerated dose of capecitabine in combination~     with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive~     LA/mGC using a Phase I design, followed by a randomized, open-label Phase II study to~     explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with~     Kadcyla alone in mBC. The anticipated time on study treatment is until disease progression,~     intolerable toxicity, or withdrawal of consent.~   "
103447|NCT01703273|"~     While adolescents with obesity and extreme obesity are at increased risk for health~     complications, especially adolescents with extreme obesity rarely seek medical care, and~     sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the~     lack of adequate treatment options.~      In this multicenter study, we aim to test a new, low key group intervention focusing on~     improving compliance and psychosocial functioning. The study is a subproject of the Medical~     and psychosocial implications of adolescent extreme obesity - acceptance and effects of~     structured care, short: Youth with Extreme obesity Study (YES), which aims at improving~     the medical care and social support structures for youth with obesity and extreme obesity in~     Germany.~      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years~     (initially up to 21 years) are eligible to participate. Participants will be asked to~     complete a series of questionnaires on their general health, psychosocial situation and~     wellbeing, and will be offered a thorough medical evaluation. Individuals who complete the~     baseline evaluations will be invited to participate in 6 group sessions over a 3 months~     period. Group assignment to the psycho-social intervention vs. routine care group will be at~     random, like throwing a dice. After 6 months, participants will complete further~     questionnaires to evaluate the effects of the interventions on quality of life and~     psycho-social functionning.~      The study will show the acceptance and effectiveness of a new intervention focusing on~     improving compliance and psychosocial functioning in adolescents with extreme obesity, and~     thereby inform the development of new treatment and support options for these adolescents.~     If interested, participants are invited to participate in additional components of YES, and~     to receive medical care and psycho-social support.~   "
103448|NCT01703260|"~     The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy~     on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.~   "
103449|NCT01703247|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, PVI plus linear~     lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding~     persistent AF. Results were assessed after follow-up of at least 3 years with the use of an~     implanted monitoring device (IMD).~   "
103450|NCT01703234|"~     There is no data about the effects of Renin angiotensin system blockage (RAS) on FGF23 and~     ADMA levels in diabetic patients with proteinuria. The aim of this study was to find out~     whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with~     the alteration of ADMA and FGF-23 levels. We searched for the effects of ACE inhibitor~     ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.~   "
103451|NCT01703221|"~     The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as~     monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up~     to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks:~     1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated~     hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in~     participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in~     participants treated with sitagliptin 50 mg daily.~   "
103452|NCT01703208|"~     The purpose of this study is to evaluate the cardiovascular (CV) safety profile of~     omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is~     that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo~     and active comparators across the omarigliptin program with regard to the risk of developing~     a confirmed event in the primary CV composite endpoint.~   "
103453|NCT01703195|"~     The goal of this clinical research study is to learn if a type of MRI scan called diffusion~     weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want~     to learn if DWI can predict how tumors will respond to radiation therapy.~   "
103454|NCT01703182|"~     TCOM is a multicentre prospective cohort study in patients undergoing lower limb~     amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb~     for 20 to 30 minutes before their surgery and will be followed up until 6 months after their~     surgery. The purpose of the TCOM study is to determine the ability of oxygen and carbon~     dioxide measurements in the legs of patients undergoing lower limb amputation to predict~     wound healing complications and to determine an optimum cutoff value for both oxygen and~     carbon dioxide levels beyond which healing complications are likely to occur and a closer~     amputation level is indicated.~   "
103455|NCT01703169|"~     The investigators hypothesis is that eltrombopag given to patients with moderate to very~     severe aplastic anemia will result in an increase in platelet counts. The investigators~     hypothesize that in patients with moderate to very severe aplastic anemia, treatment with~     eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer~     bleeding events. The investigators hypothesize that in patients with moderate to very severe~     aplastic anemia, eltrombopag will have an acceptable toxicity rate <3%, at doses that result~     in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag~     levels in peripheral blood will correlate with improved platelet counts.~   "
103456|NCT01703156|"~     A large number of patients are diagnosed with low risk ACS, and these individuals are at~     significant cardiovascular risk. Though guidelines recommend stress testing to manage low~     risk ACS patients, evidence supporting this recommendation is not based on trials examining~     this population. A well-designed, randomized trial is warranted to determine if stress~     testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the~     investigators hypothesize, healthcare expenditures could be reduced and patients may not be~     exposed to the harms associated with more invasive cardiac testing such as coronary~     angiography.~   "
103457|NCT01703143|"~     To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with~     focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and~     safe minimally invasive technique for control of seizures in such patients.~   "
103458|NCT01703130|"~     Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder~     surgery. However, patients can experience complications such as blurred vision, hoarseness~     and shortness of breath with the standard volumes of local anesthetic used in contemporary~     practice. Patients with respiratory diseases are precluded because of the potential effects~     on respiration. However, they are then exposed to the risks of general anesthesia and opioid~     medications which can also have detrimental effects on respiration. Ultrasound guided ISB~     can reduce the local anesthetic volume required to produce anesthesia for shoulder surgery;~     this may reduce the complications from ISB to allow patients previously unable to benefit to~     have this technique, such as patients with obesity and respiratory disease. In order to do~     so the investigators will use an up-down methodology to find the minimum volume of local~     anesthetic to provide sufficient anesthesia for shoulder surgery.~   "
103892|NCT01697202|"~     To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and~     which factors that may influence the fatigue.~   "
103459|NCT01703117|"~     Cognitive aging is a major source of disability in an increasingly aging population. The~     paucity of effective treatments for cognitive aging disorders, and most importantly in~     Alzheimer's disease instigates a need for further research into novel therapeutic~     possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its~     prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric~     disorders and in particular in Alzheimer's disease has been shown to cause significant~     cerebral damage. Early effective therapeutic intervention in Alzheimer's disease is critical~     in order to prevent or at least retard neuropathological progression that will lead to~     widespread irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a~     glutamate modulator agent that is a proven safe medication and has not yet been used in~     cognitive aging disorders, will be tested in mild Alzheimer's disease patients. Cognitive~     functional changes along with two established in vivo biomarkers, namely, Magnetic Resonance~     Spectroscopy (MRS) and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will~     be evaluated.~   "
103460|NCT01703104|"~     The primary objective is to determine if there is a significant increase in the haematocrit~     value of patients on Jobelyn and standard therapy compared to those on standard therapy~     alone.~   "
103461|NCT01703091|"~     The purpose of this study is to evaluate the effects of ramucirumab in combination with~     docetaxel in participants with Stage IV non-small cell lung cancer who have had disease~     progression during or after one prior first-line platinum-based chemotherapy with or without~     maintenance therapy for advanced/metastatic disease.~   "
103462|NCT01703078|"~     The purpose of this study is to determine if the new ingenol derivative gels are as safe as~     and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for~     two consecutive days.~   "
103463|NCT01703065|"~     This pilot clinical trial studies cabozantinib in treating men with castration-resistant~     prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
103464|NCT01703052|"~     This study is designed to investigate the safety, tolerability and pharmacokinetics of~     inhaled CHF 6001 after single and multiple doses in healthy volunteers.~   "
103465|NCT01703039|"~     The investigators are doing a research study to find out if riluzole, when taken along with~     a standard antidepressant (sertraline) can help people with major depression.~      This research study will compare riluzole + sertraline to placebo + sertraline. The~     investigators hypothesize that adding riluzole will lead to a better antidepressant~     response, in less time, then sertraline alone.~   "
103466|NCT01703026|"~     Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to~     detect pancreatic cancer at an earlier stage, to improve current method of T staging and~     assessment of surgical resectability and also to distinguish between benign and malignant~     pancreatic masses. All these will translate into better clinical outcome, and also avoid~     unnecessary surgery in situations of unresectable cancers.~   "
103467|NCT01703013|"~     The pathophysiology of the adrenal insufficiency of patients with critical diseases remains~     unclear. In a prior exploratory study investigating patients with exacerbation of chronic~     obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant~     correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the~     adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to~     demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level~     (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in~     inflammatory lung diseases (patients with COPD and pneumonia).~   "
103468|NCT01703000|"~     NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting~     Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of~     Atherosclerotic Lesion(s)~   "
103469|NCT01702987|"~     It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function~     and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment~     of PCr recovery kinetics in patients using statins. The investigators propose a pilot study~     to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a~     parallel arm study to either ubiquinol or placebo over 4 weeks.~   "
103470|NCT01702974|"~     The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to~     treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms~     and decreased inflammation.~   "
103471|NCT01702961|"~     High-dose chemotherapy followed by autologous (the patient's own) peripheral blood~     (circulating blood) stem cell (cells that divide to form white cells, red cells and cells~     that help clot) transplantation is a conventional treatment for patients with lymphoma~     (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse~     (recurrence of disease). For patients who did not have a complete response after traditional~     chemotherapy, the chance is high that the tumor will return even after high-dose~     chemotherapy. To improve the response and decrease the chance of relapse, doctors have used~     rituximab, an antibody that kills lymphoma cells, both before and after transplantation.~     These doctors have reported that more patients had control of the tumor for an extended~     period of time using rituximab with high-dose chemotherapy with autologous stem cell~     transplantation. How widely this is applicable is not known.~      The purpose of this clinical research trial is to confirm that there is a good control of~     tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional~     stem cell transplantation.~   "
103486|NCT01702545|"~     The current state of knowledge on the concentration of drugs and their metabolites in the~     individual human body is not satisfying concerning the question about behavior of drugs in~     the human body, taking into account individual patient factors such as age, weight and organ~     dysfunctions.~      This projects deals with the question of drug levels in the blood of hospitalized patients.~      The aim of this study is to extend the knowledge about the behavior of drugs in the human~     body significantly, for the safety and benefit of future patients. This also includes to~     establish a relationship between drug levels in patients and the desired and undesired~     effects of a drug.~      As a result, the future perspective is to find the optimal dose for the individual patient~     by measuring the blood concentration of a drug.~   "
104149|NCT01693848|"~     Observational, non randomized study aimed at measuring the effect of surgical resection of~     metastasis in the urinary concentrations of physiological modified nucleosides in 45~     patients with metastatic colorectal cancer.~   "
103472|NCT01702948|"~     Background:~      - Nicotine addiction often makes it difficult to stop smoking. Researchers want to~     understand the areas of the brain that are important in nicotine addiction. They will use a~     type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look~     at part of the brain that may be involved in nicotine addiction. They will see how these~     areas affect brain function, thinking, and decision making. For this study, rTMS will first~     be tested on nonsmokers, then smokers will be recruited at a later time.~      Objectives:~      - To study areas of the brain involved in nicotine addiction.~      Eligibility:~      - Individuals at least 18 years of age who do not smoke.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          provide a urine sample.~        -  There will be four study sessions. The first session will involve a magnetic resonance~          imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.~        -  The first MRI scan will take a baseline picture of the brain. Participants will also~          practice the tasks for the other three sessions in a mock scanner.~        -  At the next three visits, participants will have rTMS and MRI scans. Two visits will~          involve rTMS; the other visit will involve mock rTMS with no actual magnetic~          stimulation. During the MRI scans, participants will perform tasks that involve~          decision making.~   "
103473|NCT01702935|"~     Background:~      - Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means~     that the ovaries are not able to function at a level appropriate for a woman's age.~     Previously, it was thought that women had only a fixed number of eggs that were lost each~     month until none were left at menopause. However, recently, stem cells have been found in~     the ovaries of adult women. These stem cells may be able to make new eggs. Studying these~     cells may help women with POI in the future. Researchers want to collect ovarian tissue from~     women with POI to investigate ovarian stem cells.~      Objectives:~      - To collect ovarian tissue from women with primary ovarian insufficiency.~      Eligibility:~      - Women between 18 and 50 years of age with primary ovarian insufficiency.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have a full gynecological exam. They will provide blood and urine samples.~        -  Participants will donate ovarian tissue for study. It will be collected through~          outpatient surgery. The surgery will take either half of an ovary or a full ovary.~        -  Treatment will not be provided as part of this study.~   "
103474|NCT01702922|"~     Background:~      - Serious illnesses like cancer can cause high levels of stress in a family. When a child is~     diagnosed with cancer, parents face numerous stressors, each of which can strain~     relationships. Many parents struggle to effectively cope with the changes in parenting roles~     that often accompany treatment of childhood cancer. How parents cope with this stress can~     influence whether the relationship is strengthened or weakened. Stress levels can also~     affect the care of the child who has cancer. Researchers want to better understand the~     critical time points and events during the child s treatment when the relationship becomes~     most stressed and/or strengthened.~      Objectives:~      - To study how stress affects the relationship between parents who have a child with cancer.~      Eligibility:~        -  Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer.~        -  Participants must have been in a partnership at the time the child was diagnosed with~          cancer. At least one of the parents must be a biological or legal parent of the child.~      Design:~        -  Participants will fill out a questionnaire either online or by paper and pencil. It~          will take about 20 minutes to complete. The questions ask about the experience of~          dealing with a child s cancer diagnosis and how it affects participants relationship~          with their spouse/partner.~        -  Some participants will also have an in-depth interview. It will last about an hour. It~          will ask further questions about the cancer diagnosis and treatment and its effect on~          the relationship.~        -  Treatment will not be provided as part of this study.~   "
103475|NCT01702909|"~     The purpose of this study is to determine whether Interleukin-2 at the dose and schedule~     used in this study will help increase tumor shrinkage.~   "
103476|NCT01702896|"~     The purpose of this study is to determine whether Interleukin-2 at the dose and schedule~     used in this study will help to increase tumor shrinkage~   "
103477|NCT01702662|"~     Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in~     chemotherapy/radiotherapy oral mucositis.~      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule~     treatment in mice showed a significant beneficial effect on the endoscopic severity of~     DSS-induced colitis in mice.~      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill~     treatment in healthy volunteers.~   "
103478|NCT01702649|"~     RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat~     bacterial infections, including those due to multi-drug resistant bacteria.~   "
103479|NCT01702636|"~     The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have~     contrast extravasation on computed tomography angiography, the spot sign, have lower rates~     of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset,~     compared to placebo.~   "
103480|NCT01702623|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Oxcarbazepine Suspension 600 mg under fasted conditions.~   "
103481|NCT01702610|"~     Patients with GBM, who were deemed ineligible for any active protocols at our centre,~     received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with~     conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty~     five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated~     with a median KPS of 90 (range 50-100). Four patients had multicentric disease at~     presentation. Eight patients had biopsy only while the rest had a near total resection~     (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median~     survival was 14.4 months.~   "
103482|NCT01702597|"~     The aim of this bicentric, biphasic, randomized, controlled study is to compare of the~     current gold standard functional treatment to functional treatment plus WBV in patients with~     acute unilateral unstable inversion ankle sprains over a period of 12 months~   "
103483|NCT01702584|"~     Prospective registry study to evaluate safety and efficacy of stent assisted embolization of~     intracranial aneurysm.~   "
116822|NCT01526902|"~     This study is designed to compare the relative performance related to subjective and~     objective vision between two multifocal soft contact lenses.~   "
103487|NCT01702532|"~     Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of~     this study is to investigate the craving relief efficacy of nicotine mouth film by comparing~     mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving~     model. The cues used to provoke a craving episode will be the sight and smell of a lit~     cigarette and the manipulations required to light a cigarette. The smokers will be denied~     access to cigarettes for 4 hours prior to the provoked craving session in order to~     precipitate nicotine withdrawal and an increase level of cigarette craving.~   "
103488|NCT01702519|"~     Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an~     alternative supplier delivers the same nicotine blood profile as that of the currently~     approved NTS with a polyisobutylene adhesive from the current supplier.~   "
103489|NCT01702506|"~     Evaluation of the potential effect that the administration of food or antacid medication may~     have in the oral absorption of dacomitinib relative to the administration of dacomitinib in~     absence of food or antacid medication~   "
103490|NCT01702493|"~     This is an open-label, randomized, controlled, single center study to assess the safety,~     variability in exposure, and relative bioavailability of new oral formulations of SRT2104.~     This is a two part study and each part consists of screening (within 21 days of the first~     scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after~     the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their~     order of their doses will be randomized. Each subject will receive one formulation as a 500~     milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in~     the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK)~     sampling will be done pre and post each scheduled dosing session. After all 4 dosing~     sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s)~     will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part~     2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the~     completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2,~     and whether the selected formulation(s) is to be administered in the fed or fasted state for~     Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be~     obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be~     administered after a standard meal to assess the effect of food on the bioavailability of~     SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A~     single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected~     formulation(s) from Part 1 will be administered to assess the safety and PK profile of this~     dose level. The total duration will be approximately 4 weeks. Part 2C: The selected~     formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7~     consecutive days, to assess the safety and tolerability and characterize the PK profile of~     repeat dosing. The total duration will be approximately 5 weeks.~   "
103491|NCT01702480|"~     This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK]~     Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study~     investigating the PK profile of four different doses of GSK2981710. Eight subjects will~     receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning~     and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each~     period. Each subject will complete a total of four dosing sessions and 4 days of PK~     assessments in 2 weeks. The Part 1 PK data will be used for dose selection and~     pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive,~     an additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses)~     to increase confidence. A subject's total participation in Part 1 of the study will last a~     maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may~     be screened for eligibility and enrolled for Part 2.~      Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover~     design with 14-day treatment periods investigating the efficacy (cognitive performance) and~     tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710~     selected from Part 1. Part 2 of the study will include the Screening period, two Baseline~     assessments (6-8 days before each Treatment period) and two 14-day treatment periods~     separated by a minimum 7-day washout period and follow-up visit of 3 to 5 days.~     Approximately 50 to 80 subjects will be randomized to either GSK2981710 or placebo. The PD~     assessments will be performed on 6 occasions for each subject: at 2 baselines (6 to 8 days~     before Day 1 of each treatment period), post-dose on the Day 1 of each treatment period to~     assess acute effects and on Day 15 of each treatment period (which is the day after the~     final dose) to assess chronic effects. A subject's total participation in Part 2 of the~     study will last approximately up to 12 weeks including screening.~   "
103492|NCT01702467|"~     The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and~     plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a~     randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose~     design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each~     potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.~   "
103493|NCT01702454|"~     The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'~     investigational vaccine GSK2321138A in children who previously participated in study 115345~     (FLU D-QIV-004 PRI) (NCT01439360).~   "
103494|NCT01702441|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous~     injections daily for 28 days in patients with diabetic macular edema (DME).~   "
103495|NCT01702428|"~     The purpose of this study is to evaluate consistency in terms of the immune response to~     three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target~     potencies, and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is~     approved for use in the United States (US).~   "
103496|NCT01702415|"~     Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.~      Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF);~     they have an increased rate of bone fractures in comparison to the general population. CF~     patients start to lose bone density in adolescence/early adulthood due to an imbalance in~     bone breakdown and formation. Predicted survival for patients with CF has increased from 16~     years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities~     associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous~     bisphophosphonates are known to increase bone density in CF; the current licensed oral~     preparations require daily or weekly dosing which are difficult to maintain. Zoledronate,~     which is licensed for use, is administered intravenously once a year which should be easier~     to administer. The current evidence relates to its use in other disease groups e.g.~     glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain~     its efficacy in cystic fibrosis.~   "
103497|NCT01702402|"~     The proposed operations research study is designed to evaluate a package of family planning~     services and related behavior change interventions aimed at addressing the unmet need for~     family planning in postpartum women, integrated with an ongoing maternal and newborn health~     program, and to assess the program's impact (1) on knowledge of healthy fertility practices,~     (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum~     birth spacing, and (4) to examine the feasibility and sustainability of the proposed~     integrated service delivery approach. The study will have a quasi-experimental design, with~     evaluation primarily through household surveys in four intervention unions and four~     comparison unions (unions are lowest local government entities with an average population of~     about 20,000) in rural Sylhet District, Bangladesh.~   "
103574|NCT01701401|"~     The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without~     ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic~     genotype 1 HCV infection.~   "
103498|NCT01702389|"~     Remifentanil is a rapid-acting opioid which has been widely used in pain treatment during~     surgery for the last 15 years 1. Remifentanil is rapidly eliminated (minutes) from the body~     after end of infusion, and this makes it easily manageable compared to other opioids.~     However, there are both experimental and clinical studies indicating that remifentanil,~     after end of infusion, triggers increased pain sensation and increased opioid consumption~     post-operatively. Increased post-operative opioid consumption should be avoided due to the~     adverse effects of these drugs (nausea/vomiting, pruritus, dizziness, fatigue and reduced~     respiratory rate). Thus, it's important to investigate relevant strategies to avoid the~     increased pain sensation (opioid-induced hyperalgesia = hypersensitivity to pain stimuli)~     after end of infusion of remifentanil after surgery. Several experimental and clinical~     trials have been conducted in this field. Ketamine has been shown to block this effect, but~     its adverse effect profile (i.a. hallucinations) makes it not suitable in normal clinical~     use. In a study of healthy volunteers, it has been demonstrated that parecoxib (a COX-2~     selective NSAID) can prevent remifentanil-induced hyperalgesia. Our group has previously~     shown that a relatively COX-1 selective NSAID (ketorolac) can prevent hyperalgesia in an~     experimental pain model.~      This is of interest since NSAIDs are frequently administered as premedication before~     surgery. There are several disadvantages associated with the use of COX-2 inhibitors, e.g.~     the risk of myocardial infarction after long-term use (> 1 year), and potentially reduced~     bone healing after orthopedic surgery. However, this has not been shown with short-term use~     (days/week). The disadvantages associated with the use of e.g. ketorolac (a COX-1 inhibitor)~     are i.a. increased bleeding tendency, which is unfavourable for the surgeon, and increased~     risk of gastric ulcer. Therefore, it is of interest to investigate other ways of preventing~     opioid-induced hyperalgesia. In a recent animal study it has been shown that gradual dose~     reduction of remifentanil (vs. abrupt withdrawal of a relatively high remifentanil dose) can~     prevent the development of hyperalgesia after end of infusion. In this study we will i.a.~     investigate whether this is also the case in humans. In this new model, the study~     participants will get remifentanil infusion with two different dose reduction regimes:~     gradual reduction or abrupt withdrawal.~   "
103499|NCT01702376|"~     This will be a randomized, placebo-controlled, single, oral dose, four-way Williams~     crossover study design in healthy male and female subjects. The study consists of screening~     (28 days), treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the~     total duration of study participation for each subject will be approximately 9 weeks. Each~     subject will participate in 4 dosing sessions separated by a minimum 7-day washout period.~     All subjects will receive single doses of retosiban 100 mg, (treatment A) retosiban 800 mg~     (Treatment B), moxifloxacin 400 mg (Treatment C) and placebo (Treatment D) in one of the~     four treatment sequences (ABDC, BCAD, CDBA, DACB) following a Williams design Twelve-lead~     ECGs and continuous Holter monitoring, clinical laboratory safety tests, vital sign~     measurements, physical examinations, adverse event reports, and pharmacokinetic samples will~     be collected throughout the study. In each study period, cardiac conduction will be measured~     using a 24-hour continuous 12-lead Holter monitor from the morning of Day 1 (dosing) until~     the morning of Day 2.~   "
103500|NCT01702363|"~     The objective of this study is to evaluate the safety and tolerability of GSK573719~     Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.~   "
103501|NCT01702350|"~     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that~     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with~     tRNA and is currently in development for the treatment of hospital acquired Gramnegative~     infections.~   "
103502|NCT01702337|"~     This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and~     the quadrivalent HPV vaccine (HPV-2).~   "
103503|NCT01702324|"~     The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on~     plaque Psoriasis Vulgaris.~      The study will include subjects at plaque stage from 5-20% body area involvement. A total of~     30 subjects will be treated with cream application on affected areas twice daily for three~     weeks.The efficacy of the preparation will be documented by PASI score, Global physician~     assessment and photos.~   "
103504|NCT01702311|"~     Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of~     diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting~     information on BG levels at different time points during the day in order to assess glycemic~     control and to guide insulin adjustment/correction doses. Although POC testing provides~     insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of~     insulin supplements that may result in increased frequency of hypoglycemia and is expensive~     with an estimated annual cost in hospitals of several hundreds of millions of dollars in the~     U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin~     supplementation (correction doses) at bedtime in improving glycemic control and in~     preventing hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of~     250 non-ICU medical and surgical patients treated with basal bolus regimen will undergo POC~     testing before meals and bedtime (standard of care) and half of the patients will receive~     insulin correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol,~     while the other half will be followed without insulin supplementation at bedtime except for~     extreme hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University~     Hospital and Grady Memorial Hospital.~   "
103505|NCT01702298|"~     The purpose of this study is to examine the safety and tolerability of sitagliptin 100~     mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus~     with inadequate glycemic control on metformin.~   "
103506|NCT01702285|"~     The main purpose of this study is to determine the safety and tolerability of orally~     administered CUDC-101 in cancer patients, and to determine a dose for further testing. This~     study will also determine how well CUDC-101 is absorbed into the blood after being given~     orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and~     study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has~     been administered to cancer patients as an intravenous (IV) infusion in other research~     studies, but has not been studied when given orally.~   "
103507|NCT01702272|"~     The objective of this study is to test individual donor samples (IDSs) with the~     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue~     Assay in the clinical setting.~   "
103508|NCT01702259|"~     The purpose of this study is to determine whether the application of green diode low level~     laser light therapy is effective in reducing the appearance of cellulite in the thighs and~     buttocks.~   "
103509|NCT01702246|"~     The purpose of this study is to determine whether simvastatin is effective in reducing the~     frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell~     disease.~   "
103510|NCT01702233|"~     To evaluate functional, clinical, and subjective parameters in patients with rotator cuff~     syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections~     and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active~     treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany,~     Belgium and Spain.~      Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and~     175 of them received at least one dosage of treatment~   "
103511|NCT01702220|"~     The overall goals of the proposed research study are to: (1) examine quantitative outcomes~     in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community~     Care, an information and referral intervention that represents care in a real-world~     community-service environment, and (2) evaluate implementation feasibility, which includes~     training community providers; examining program reach, engagement, acceptability, and~     barriers-facilitators; and preparing practical tools for replicating the program.~   "
103512|NCT01702207|"~     Current standard prophylactic immunosuppression in renal transplantation includes~     tacrolimus, a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been~     available as a twice daily formulation marketed as Prograf® since 1997. It has recently~     become available in an extended release formulation called Advagraf®, which is dosed once~     daily. Advagraf® has been demonstrated to be therapeutically equivalent to Prograf® in the~     renal transplant maintenance population, and as a result it has been is approved as an~     alternative to the twice daily formulation in these patients. There is an evolving and~     expanding positive clinical experience with Advagraf® in kidney transplantation and it has~     shown to be preferred by many patients, due to the diminished dosing frequency. In clinical~     trials, Advagraf® has been shown to have other potential benefits over Prograf® such as less~     inter and intra-patient variability, improved cardiovascular profiles, and improved kidney~     function. Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as~     well as a lower Cmax or 'peak' concentration. The purpose of this study is to convert~     stabilized renal transplant patients currently receiving Prograf® to Advagraf®, to~     investigate these potential therapeutic benefits.~      The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the~     Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general~     population. Surrogate markers are widely used in clinical trials to shorten follow-up~     durations. In this study, the investigators will use the Framingham Risk Score and Reynold's~     Risk Score to quantify changes in estimated cardiovascular risk. The investigators also~     intend to examine novel inflammatory markers to investigate cardiovascular risk.~      The investigators hypothesize that the more consistent drug exposure and lower Cmax noted~     with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers~     of inflammation in kidney transplant recipients.~   "
103513|NCT01702194|"~     The purpose of this study is to determine TD-1211 is processed by the body.~   "
103514|NCT01702181|"~     The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in~     adult subjects with atopic dermatitis~   "
103515|NCT01702168|"~     Aim: To identify, assess, and address organizational context and provider-level barriers and~     facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods~     approach in a diverse community mental health center (CMHC), Massachusetts General Hospital~     Chelsea Health Clinic (MGH Chelsea).~      Hypothesis: Anticipated barriers may include, but are not limited to, organizational~     climate, heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and~     provider motivation to learn EBT.~   "
103516|NCT01702155|"~     The purpose of this study is to determine the safety and efficacy of DFP-10917 given via~     continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).~   "
103517|NCT01702142|"~     A team of researchers from the University of Wisconsin-Madison College of Engineering and~     Oregon Health & Science University will test whether clinician training and the use of~     organizational change strategies are sufficient for disseminating an evidence-based practice~     (EBP), or if changes to both organizational systems and payer policy results in greater EBP~     use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based~     practices could provide a contribution to dissemination and implementation science. This~     study will employ an intervention that was developed through the Robert Wood Johnson~     Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization~     partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs~     such as medication-assisted treatment for substance abuse disorders. The resulting AR~     Framework of payer and organizational change strategies will be tested against its ability~     to increase the use of the addiction medication buprenorphine as compared to organizational~     change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or~     opioid-based pain medications for non-medical use. Buprenorphine has experienced low~     adoption rates and is not a standard part of addiction treatment. In Ohio, the location of~     the study, deaths to due to accidental overdoses of opioids has increased by 304% over the~     past decade and surpassed auto accidents as the leading cause of accidental deaths in 2006.~     Ohio was selected for the study because of the public health significance of opioid abuse~     and because each county in Ohio acts as a stand-alone payer, offering 48 unique eligible~     payer environments. This trial will develop a deeper understanding of the role payers and~     treatment organizations play in implementing and disseminating EBPs and will focus on the~     public health issue of rising opioid abuse.~   "
103518|NCT01702129|"~     Background: Site-specific delivery of anti-cancer therapeutics is paramount for both~     reducing nonspecific toxicities and increasing efficacy of chemotherapeutic agents. Due to~     their small molecular size and nonspecific mechanisms of action, most conventional~     chemotherapies result in significant toxicities that limit the effectiveness of treatment~     and reduce the overall quality of life for cancer patients. Encapsulation of these toxic~     agents inside lipid-based carrier systems (so-called liposomes) results in passive targeting~     of the compounds to solid tumors. The preferential delivery of liposomal drugs to solid~     tumors is mostly due to altered barrier-properties of tumor-associated vessels. This results~     in both an improved delivery and at the same time a significantly milder toxicity profile.~     Recently, the specificity of delivery was further increased by attaching monoclonal~     antibodies or antibody fragments to the surface of liposomes (=immunoliposomes,~     antibody-linked nanoparticles). Antibody-coated immunoliposomes attach more selectively to~     antigens expressed on the target cells and they are internalized more efficiently.~     Furthermore, there is evidence that drug resistance, a major challenge in cancer treatment,~     may be overcome by such delivery systems. A logical and accessible target, such as EGFR, is~     overexpressed on a variety of primary human cancer cells and it is involved in signaling~     pathways that contribute both to tumor initiation and tumor progression. Recently, the~     investigators have tested immunoliposomes against the epidermal growth factor receptor~     (EGFR) in a preclinical setting. Based on the preclinical results we have initiated this~     phase I clinical trial.~      Study hypothesis: The investigators hypothesize that anti-EGFR-immunoliposomes selectively~     deliver cytotoxic compounds to EGFR-overexpressing tumors cells. Specific delivery is~     supposed to increase efficacy while reducing side-effects of the compound. The primary~     objective of this phase 1 trial is the determination of the maximum tolerated dose (MTD) for~     future phase 2 trials of this nanoparticle.~   "
103519|NCT01702116|"~     This is a study that compares two types of surgery for rectal cancer. There are two~     procedures that can be used during this surgery, conventional abdominal resection (APR) and~     extended (or extralevator) APR. The investigators are doing this research to see whether the~     extralevator APR increases the likelihood that the edge of the tissue that is removed will~     be more likely to be free from cancer cells compared with the conventional APR surgery. At~     this time there is no evidence that one type of procedure is better at this than the other.~     The objective of this research is to determine whether extralevator APR is more likely to~     have clean margins (free of cancer) compared to the standard APR surgery.~   "
103520|NCT01702103|"~     Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the~     relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week~     8 from baseline of Total Nasal Symptom Scores (TNSS).~   "
103521|NCT01702090|"~     The purpose of this study is to provide early access to TMC114 administered with low-dose~     ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have~     not received previous HIV treatment or have received early treatment without TMC114~     regimens.~   "
103584|NCT01701271|"~     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named~     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.~   "
103902|NCT01697072|"~     This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of~     epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated~     advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma~   "
103522|NCT01702077|"~     The aim of this study is to train patients with tic disorders to control activity in a~     region of their brain that has been associated with the urge to tic. Patients will be given~     direct feedback regarding activity in this brain area while they are undergoing functional~     magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the~     region during these feedback sessions. In separate sessions, patients will be given sham~     feedback based on the brain patterns of a prior subject rather than their own brain~     patterns. Our primary hypothesis is that the biofeedback training will reduce their tic~     symptoms more than the sham feedback.~   "
103523|NCT01702064|"~     This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination~     with nilotinib in patients with chronic myeloid leukemia (CML).~   "
103524|NCT01702051|"~     Islet autotransplantation (IAT) is a therapeutic approach used to prevent pancreatogenic~     diabetes or to reduce the severity of diabetes after a major pancreatectomy. Total~     pancreatectomy with IAT is being used almost exclusively for treatment of chronic~     pancreatitis. More recently, indications other than chronic pancreatitis have been reported~     including IAT after extended pancreatectomy performed for the resection of benign tumors of~     the mid-segment of the pancreas or IAT after total pancreatectomy for severe abdominal~     trauma In this study, we study our experience with IAT for the treatment of a broader~     population of patients undergoing pancreatic surgery including subjects with technically~     unfeasible or high risk pancreatic anastomosis during partial pancreatectomy and subjects~     undergoing completion pancreatectomy because of anastomosis leakage after~     pancreatoduodenectomy for nonmalignant or malignant diseases.~   "
103525|NCT01702038|"~     The purpose of this study is to determine how B cell subsets and autoantibodies are related~     to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus~     (SLE).~   "
103526|NCT01702025|"~     In low oxygen environments, such as altitude, some adults may become ill and suffer from~     acute mountain sickness. Further, all adults will find that exercising becomes much more~     difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of~     this investigation is to study the effects of two drugs that may help people adjust to~     high-altitude quickly, prevent them from becoming ill and improve their exercise~     performance. The drugs are Methazolamide and Aminophylline.~   "
103527|NCT01702012|"~     A 12 month multi-center randomization controlled study. Participants will be randomized to~     either a lifestyle education program or a meal replacement regimen with Almased, after an~     initial examination of eligibility criteria.~      Primary outcome-HbA1c~   "
103528|NCT01701999|"~     Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate~     safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine~     A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the~     pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing~     antibody levels for botulinum toxin types A and B in healthy subjects who were previously~     immunized with the PBT for occupational protection and who receive the rBV A/B. Subjects~     with titers of the neutralizing antibodies against the toxins would be candidates for plasma~     donation for BabyBIG production.~   "
103529|NCT01701986|"~     The goal of this clinical research study is to find the highest tolerable dose of~     gemcitabine (out of 6 possible doses) that can be given in combination with busulfan and~     clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if~     this combination can help to control lymphoma. The safety of this treatment will also be~     studied.~      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer~     cells to die. It is commonly used in stem cell transplants.~      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may~     cause the cancer cells to die.~   "
103530|NCT01701973|"~     This study tests the following hypotheses:~      Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the~     currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone~     (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone~     releasing hormone (GHRH).~      Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition~     will result in an increase in endothelium-dependent vasodilation mediated by GH and~     independent from GLP-1 in healthy lean adults.~      This study promises to provide novel data regarding how this increasingly used class of~     anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation.~     Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study~     may evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with~     obesity and pre-diabetes.~   "
103531|NCT01701960|"~     1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal~     mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and~     visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.~     However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is~     also used. This latter dose theoretically should have a lesser effect on cardiac stimulation~     which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa~     has excellent absorbing ability which is great for the application of drugs but there is~     concern for systemic absorption and side effects. Potential serious side effects can occur~     with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side~     effects occur mainly through the absorption of epinephrine. It is the goal of this study to~     see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field~     with a decrease in hemodynamic side effects.~   "
103532|NCT01701947|"~     The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement~     coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the~     opinion of the treating physician, the benefits of administering selectively the missing~     factor outweigh the potential risks associated with the administration of fresh-frozen~     plasma.~   "
103533|NCT01701934|"~     The purpose of this study is to determine whether roflumilast can improve metabolic profile~     and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).~   "
103534|NCT01701921|"~     The purpose of this study is to determine whether pregabalin is effective in the treatment~     of acute postoperative pain after cardiac surgery if administered before the surgery.~   "
131626|NCT01332383|"~     To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on~     Japanese patients with migraine headache in clinical setting~   "
103535|NCT01701908|"~     Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according~     to the population under examination and the criteria used to define pulmonary complications.~     There is no univocal definition of PPCs. Usually physicians associate atelectasis,~     respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the~     evaluation of risk factors has become difficult.~      The endpoint of this study is to determine the actual incidence of respiratory postoperative~     complications in patients undergoing general anesthesia for major abdominal surgery (general~     surgery, gynecology, urology).~      This is an observational, descriptive, prospective, multicentric study. Investigators are~     going to enroll all the patients matching the inclusion criteria and follow them until~     discharge (clinical phase). Then they will be followed up until one year later.~   "
103536|NCT01701895|"~     The purpose of this research study is to evaluate how easy it is for female HIV- positive~     subjects taking Complera to comply with the dietary requirement using a food diary in the~     short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association~     between calorie intake and virologic suppression. A secondary goal of the study is to~     evaluate subjects' attitudes towards contraception.~   "
103537|NCT01701882|"~     The purpose of the study is to investigate the benefits of switching away from efavirenz~     (which patients are taking in combination with Kivexa® or as part of the combination pill,~     Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty~     with sleeping}, bad dreams etc). The investigators in this study will investigate the effect~     of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and~     rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new~     component of the combination.~      Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination~     with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical~     studies, where patients were starting HIV treatment for the first time.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness,~     your viral load and CD4 counts, when you switch treatment to~     tenofovir/emtricitabine/rilpivirine.~   "
103538|NCT01701869|"~     Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and~     the only one of the common causes that is still rising. The main effects of the disease are~     the destruction and inflammation of lung tissue rendering breathing difficult. COPD has~     significant effects on the quality of life of sufferers and the disease is predicted to be~     the fifth most common cause of disability in the world by 2020. Patients with COPD are prone~     to periods of worsening disease symptoms, known as exacerbations, which are often caused by~     viral and bacterial infections of the lung and current vaccines appear to have little~     efficacy in limiting these exacerbations. The loss of lung function caused by infectious~     exacerbations is irreversible and patients who frequently exacerbate experience more rapid~     disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species~     that colonises the airways and causes exacerbations in COPD. With the development of more~     sensitive molecular techniques it has been possible to ascertain that it is the acquisition~     of new strains of NTHi that correlate strongly with exacerbations. However, not all patients~     with COPD have NTHi in their lungs and the question remains as to why some COPD patients are~     susceptible to such infections. This study aims to answer this question by comparing the~     airways of COPD patients who are colonized by NTHi and those who are not to analyse whether~     the levels of protective antibodies in the lungs and the function of the immune cells in the~     NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity~     with areas of lung damage ascertained by high resolution computed tomography. The aim of~     this research is to better understand this apparent deficiency in airway immunity as this is~     likely to impact on vaccine efficacy in COPD.~   "
103539|NCT01701856|"~     Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young~     adults affecting approximately 1 in 1.000 people in western countries. The clinical~     manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at~     onset with acute episodes of neurological dysfunction, followed by periods of partial or~     complete remission and clinical stability in between relapses. This relapsing-remitting~     phase (RR-MS) of the disease is usually followed by progressive clinical disability~     (secondary progressive phase, SP-MS).~      At present, there is no cure for MS. Based on the pathological concept that~     neuroinflammation is the common element leading or contributing to neurodegenerative~     changes, immune interventions have been introduced into clinical practice such as~     Natalizumab (Tysabri), a humanized monoclonal antibody. Natalizumab (Tysabri) is indicated~     as a disease-modifying monotherapy of highly active relapsing MS. The associated risks,~     especially progressive multifocal leukoencephalopathy, necessitate active monitoring of~     patients and a continuous discussion of optimum use of this drug. In clinical practice, the~     question how to manage patients on natalizumab at a higher risk for progressive multifocal~     leukoencephalopathy remains unresolved.~      This prospective, controlled (comparison to the period prior to natalizumab treatment),~     single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of~     natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple~     sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In~     particular, to evaluating if interferon beta-1b treatment may be able to overcome the~     recurrence of significant clinical and radiological disease activity after natalizumab~     cessation and may keep disease activity better under control as compared to the time prior~     to natalizumab.~      The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS)~     being treated at least for 12 months with natalizumab and having decided to stop natalizumab~     treatment and to de-escalate their therapy to a first line treatment with interferon~     beta-1b. They will be treated during 12 months with interferon-beta 1b 250 mcg given~     subcutaneously every other day. A 12-month follow-up period with the same treatment is~     planned.~   "
103540|NCT01701843|"~     The purpose of this exploratory study is to investigate the clinical efficacy of study drug~     (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right~     comparison study in male/female subjects with mastocytosis, in a prospective,~     double-blinded, randomised, single centre setting.~   "
103541|NCT01701830|"~     The aim of the study is to evaluate whether a low level of serum omentin-1 is associated~     with carotid atherosclerosis and mediated by inflammation.~   "
103542|NCT01701817|"~     The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is~     a multicenter, prospective outpatient disease registry to evaluate the utilization of~     target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct~     thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will~     permit the collection and analysis of post-approval observational data needed for evaluating~     the outcomes associated with these new agents when used in broader patient populations~     outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly~     diagnosed atrial fibrillation (AF) as well as those who have been recently started on a~     target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II~     registries will offer a broad and contemporary view of AF therapy.~   "
103543|NCT01701804|"~     The purpose of this study is to investigate the effect of a non-surgical integrative package~     consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture,~     acupuncture on failed back surgery syndrome through means of a prospective case series.~   "
104008|NCT01695681|"~     The purpose of this study is to determine the prevalence of previously undiagnosed coeliac~     disease based on a health survey from Tromsø, Norway. Moreover, the health impact of~     undiagnosed coeliac disease will be examined.~   "
103544|NCT01701791|"~     Background: In Italy, several recent studies found that a large percentage of patients~     attending Primary Care (PC) clinics meet criteria for at least one common mental disorder,~     as they show high rates of depression, anxiety, and co-morbid anxiety and depression. These~     patients may experience significant functional impairment and suffer from unexplained~     somatic symptoms, and often remain undetected and untreated. Consistent evidence for the~     effectiveness of organized care programs for depression, by improving quality of care and~     treatment adherence, is now available. Fundamental elements of these programs include~     algorithms to prompt the proper and timely implementation of evidence-based treatments,~     structured outcome assessment and systematic outreach. Telemedicine tools may represent a~     valuable strategy for improving depression outcomes in PC.~      Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect~     patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care~     support program developed in conjunction with the PC-based assessment for patients suffering~     from depression, as based on two main objectives: 2a.To support GP decisions with treatment~     algorithms and improve the quality of GP and mental health service collaboration; 2b.To~     improve patient compliance and treatment adherence by using appropriate telecommunication~     tools and technologically advanced tools to conduct systematic routine assessment. Although~     much of this system will be computer-based, live telephonic and in-person contacts will also~     be included as needed.~      Study Design: The study is a randomized controlled trial, involving four PC group clinics~     (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental~     protocol; the other two will serve as controls.~      The study will compare two different conditions:~        -  Group 1 (experimental): GPs will use a Computer Decision Support System with treatment~          algorithms and advice and supervision from a consultant psychiatrist. Patients will~          receive reminders via mobile texting or automatic mobile (or landline) phone calls to~          improve adherence to the treatment prescribed.~        -  Group 2 (control): GPs will provide TAU, will make their own decisions and will~          therefore not use the CDSS. Patients will not receive any reminders. All enrolled~          patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months:~          the IDS-SR score will be used as a primary endpoint.~   "
103545|NCT01701778|"~     The purpose of this study is to compare the effects of caudal dexmedetomidine with~     intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower~     abdominal surgeries.~   "
103546|NCT01701765|"~     An increasing number of severely ill patients require long-term care in non-hospital~     Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed~     longitudinal studies on fairly larger samples of residents have provided important~     information about this population. The PERDOVE study is the first study carried out in Italy~     aimed at obtaining comprehensive data about the course and outcome of patients living in~     RFs, and test whether discharge to independent accommodations is a real option for many~     patients. The major aims are three: (1) to describe the sociodemographic, clinical, and~     treatment-related characteristics of patients treated in RFs during an index period in 2010;~     (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;~     and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each~     individual patient. The primary endpoint was discharge within one year as a measure of good~     outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging~     to the St John of God Order, located in Northern Italy. The first step involves the~     evaluation of all RFs with a Structure Schedule, which assesses the following areas:~     logistics structure, general organization: internal rules, meals, clothing and personal~     hygiene; staff and users' characteristics and meetings, documentation system and evaluation~     activities; rehabilitative activities provided inside the RF itself. In the second step a~     research assistant completed a standardised assessment of each resident with the manager and~     staff; clinical diagnoses were made by treating clinicians. A number of standardised~     instruments were administered. At one year follow-up, changes in clinical and life~     conditions of the patients were evaluated and selected rating scales were administered~     again. For patients discharged to the community or to other RFs, a research assistant~     contacted the patient's psychiatrist and asked him/her to fill out the follow-up~     documentation. With regard to residents' discharge, investigators hypothesised that the~     likelihood of community discharge would be associated both with the level of social support~     outside the facilities, and with the degree of patients' psychological and social~     impairment.~   "
103547|NCT01701752|"~     This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated~     with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,~     subjects that are more representative of the target population. Both formulations will be~     administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)~     vaccine.~   "
103548|NCT01701739|"~     This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and~     safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers.~     In period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will~     receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on~     study treatment is one month.~   "
103549|NCT01701726|"~     This is a large scale, open-label, multicenter, randomized controlled clinical trial with~     four parallel arms. This trial aims to evaluate the effectiveness of affected meridian~     acupuncture for patients with mild hypertension,with respect to decreasing their blood~     pressure, safety of acupuncture ,and improving their quality of life as well.~   "
103550|NCT01701713|"~     The purpose of this study is to determine the safety of transcranial direct current~     stimulation in aphasia therapy in acute and post-acute stroke.~   "
103551|NCT01701700|"~     Over 1 million people in the UK suffer from untreatable visual impairment, many of them~     elderly. The major complaint of visually impaired people is their inability to carry out~     simple tasks, especially those involving reading. It is known that this activity limitation~     is a major cause of depression in an older population, and it is reflected in reduced~     quality of life. Low vision clinics, mostly based within hospital ophthalmology departments,~     dispense optical magnifiers to allow patients to carry out these tasks again, but these~     devices do have limitations (unusual posture, short working distance, monocular viewing).~     Although electronic magnifiers have been around since the 1960s, they were initially very~     large and expensive. Recent advances in technology have brought about an explosion in the~     number and range of portable and moderately-priced aids, which can be used binocularly, in a~     natural working position: these are currently not available through the NHS. Evidence is~     needed as to whether these portable hand-held electronic magnifiers could offer a~     significant benefit to the majority of patients, and therefore whether they should be~     routinely dispensed in low vision clinics.~      The proposed study is a two-arm randomised crossover trial with existing users of optical~     magnifiers being assigned to use a hand-held electronic magnifier in addition to their~     existing devices for 2 months. Reading and task performance will be measured with the aid,~     and compared to the performance with optical aids, and the patient will be asked to report~     on the comparisons between the aids.~   "
103597|NCT01701102|"~     Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in~     ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic~     (a medication that, when injected around nerves, blocks nerve conduction, resulting in~     numbness and weakness) used in the spine, but too low a dose can result in an incomplete~     block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of~     fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this~     study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with~     fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.~   "
104826|NCT01685021|"~     This is an open-label, multicentre study to characterize the safety and preliminary efficacy~     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell~     acute lymphoblastic leukemia (B-ALL)~   "
103552|NCT01701687|"~     Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to~     correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an~     inert dye which is purely extracted from the blood by liver cells, and is hence an excellent~     marker of both liver cell function and overall liver blood flow. There is little data for~     either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to~     establish the accuracy of these liver biomarkers in predicting important liver related~     outcomes (death, transplantation and hospital readmission with cirrhosis related~     consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we~     will assess whether the serial measurement of biomarkers has any impact on alcohol~     abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital~     inpatients with decompensated alcoholic liver disease will undergo baseline biomarker~     measurement, routine blood and urine tests and qualitative questionnaires. These will be~     measured during their initial hospital admission (0 months) with subsequent repeat~     measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be~     in the region of 30-40 minutes to complete these investigations. The end of the study for~     individual patients will be patient death, liver transplantation or 6 month from study~     enrolment; whichever occurs first.~   "
103553|NCT01701674|"~     Purpose of this Pilot Study: The investigators want to study the safety, side effects, and~     benefits of TILs when they are given with the drug ipilimumab. Ipilimumab is a type of~     immunotherapy - a drug that is used to boost the ability of the immune system to fight~     cancer, infection, and other diseases.~   "
103554|NCT01701661|"~     Randomized controlled trial, a method used to implement the random allocation sequence is~     numbered containers.~      The aim of the study is to compare compression therapy with compression stockings and~     surgery eliminating superficial venous reflux in patients with duplex ultrasound verified~     superficial venous reflux without skin changes or ulceration.~   "
103555|NCT01701648|"~     Vitiligo is an acquired skin disease that significantly impacts the quality of life of~     patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but~     the results are variable.~      This single center, single blind clinical trial comparing another treatment and also no~     treatment was designed to assess the efficacy of autologous monocyte transplantation in~     monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo.~     Patients will receive the two interventions, melanocyte suspension and monolayer on amniotic~     membrane and will provide an untreated area as a control.~   "
103556|NCT01701635|"~     A culturally-relevant, theoretically and empirically sound, patient-centered, standardized~     disclosure intervention that can be integrated into routine clinical pediatric HIV care has~     potential to prevent transmission and improve the welfare of children and their caregivers~     in Ghana and other resource-limited settings. Results from this project will also further an~     understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis~     is that several key barriers to disclosure of HIV status can be modified and the process of~     disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian~     concept.~   "
103557|NCT01701622|"~     Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood~     pressure) and overall cardiovascular disease risk in several studies. The relationship has~     even been noted to be independent of metabolic syndrome and kidney function. It has been~     repeatedly noted that hyperuricemia was an independent risk factor of death in those at high~     cardiovascular disease risk. A recent review concluded that there is strong evidence that~     hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.~      Although this correlation of hypertension and hyperuricemia is known, there has only been~     one published study that has evaluated if lowering the uric acid would reduce the blood~     pressure. The authors concluded that in newly diagnosed hypertensive adolescents,~     allopurinol decreased the blood pressure. Despite this, further evaluation of this~     therapeutic approach has not been studied.~      The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood~     pressure lowering effects superior to allopurinol in patients diagnosed with gout.~   "
103558|NCT01701609|"~     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia~     improving functional outcome. But most of the studies have involved participants who are in~     average in their mid 30s, and little is known about the efficacy of CRT in adolescents with~     early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in~     improving cognitive performance and functional outcome in adolescents with EOS. We expect to~     find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.~   "
103559|NCT01701596|"~     This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in~     nondilatable calcified lesion complicated by coronary dissection during percutaneous~     coronary intervention (PCI) procedure.~   "
103560|NCT01701583|"~     This study looks at changes in cell proteins in people with chronic hives treated with~     omalizumab.~   "
103561|NCT01701570|"~     The investigators plan to learn more about how different levels of exercise feel to people~     with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team~     will also look at what causes exercise to feel harder or easier to people with and without~     Type 2 Diabetes. The investigators will also compare the potential benefits of supervised~     exercise training to that of diabetes education/blood sugar monitoring.~   "
103562|NCT01701557|"~     Randomized trial to determine if the volume of fluid administration in pediatric patients~     with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of~     treatment~   "
103598|NCT01701089|"~     This open-label, multiple dose, parallel group study will assess the monoamine oxidase in~     the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients~     with Alzheimer disease and in healthy volunteers. Patients and volunteers will receive~     multiple doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.~   "
103652|NCT01700374|"~     The purpose of this study is to determine how difficult life-events that women experienced~     during their childhood might affect their babies.~      Women who are asked to participate in this study will fill out forms about their physical~     and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress~     responses measured and have their baby's development and stress responses assessed.~   "
103563|NCT01701544|"~     We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving~     cognitive deficits in PD patients referred and eligible for conventional DBS treatment for~     coexisting motor impairments. Six patients with PD with both motor fluctuations and~     cognitive impairments (including but not restricted to deficits in attention and working~     memory) will have bilateral electrodes implanted to ensure that superficial contacts lie in~     the conventional motor GPi target, while the deepest electrical contacts lie in the NBM-~     (see figure 1). We will place electrodes using our conventional image guided, stereotactic~     frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2~     groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or~     switched off separated by a 1 month washout period, following which the patient will cross~     over to have the opposite condition for a further 3 months- see timeline. At the end of the~     crossover period, all patients will be invited for continued follow up with stimulation~     switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients~     will be given the option of receiving additional conventional stimulation to the motor GPi,~     through the higher contacts of each electrode, at the end of the crossover period.~   "
103564|NCT01701531|"~     The objective of this study is to measure the change in hemoglobin levels after the~     administration of an amino acid based, RBC precursor formulation.~   "
103565|NCT01701518|"~     To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected~     at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for~     idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as~     demonstrated by a gain in vision and decreased in retinal thickness and volume.~   "
103566|NCT01701505|"~     The purpose of this study is to assess the efficacy and safety of intranasally administered~     Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.~   "
103567|NCT01701492|"~     This is an observational study to collect information by use of performance-based measures~     and survey questionnaires. It does not include interventions aimed at altering patient~     outcome.~      Advances in pediatric hematopoietic stem cell transplantation (SCT) have resulted in~     improved survival and prompted increased attention to the potential adverse late effects of~     this procedure. Survivors of SCT are thought to be at risk for neurocognitive deficits as a~     result of their exposure to a number of potentially neurotoxic agents. Prior studies done by~     our group and others have demonstrated generally stable cognitive function in the first 5~     years following transplant, with little evidence of significant declines. However, there has~     been almost no research to date on the status of very long-term (> 5 years post-transplant)~     survivors. In this study, we will evaluate a large sample of long-term survivors of~     allogeneic SCT using measures of intelligence, academic achievement, and specific cognitive~     functions such as attention, working memory and processing speed. We will also obtain~     measures of behavioral functioning and quality of life. We will examine how this group of~     survivors are functioning relative to normative expectations, and in comparison to community~     controls without a history of serious illness, matched on age, gender, race/ethnicity, and~     socioeconomic status. We will also examine the relationship between cognitive function and~     psychosocial function and quality of life in this population.~   "
103568|NCT01701479|"~     The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination~     with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and~     young people with primary refractory or relapsed neuroblastoma without intravenous morphine.~   "
103569|NCT01701466|"~     The purpose of this study is to determine whether NeoVIDERM is effective at preventing~     radiation dermatitis in patients receiving external beam radiation therapy to the head and~     neck or breast areas.~   "
103570|NCT01701453|"~     1. Objective To test the safety of 6 month-duration of DAPT compared to conventional~          12-month-or-longer duration after second-generation DES implantation in patients with~          acute coronary syndrome.~        2. Hypothesis A 6-month duration of DAPT is non-inferior to a conventional~          12-month-or-longer duration of DAPT at preventing the occurrence of major adverse~          cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES~          implantation in patients with ACS~   "
103571|NCT01701440|"~     In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and~     improve contour and cosmesis.~   "
103572|NCT01701427|"~     Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper~     structures as well as the skin. Whether this is one combined pain syndrome, where for~     instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain~     conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical~     stimulation in deeper tissues in the groin and recording the skin sensory function, this~     hypothesis will be tested~   "
103573|NCT01701414|"~     The purpose of this study is to determine if ultrasound guided femoral nerve blocks~     (localized anesthesia in the upper thigh) provide effective pain relief in adult patients~     with hip fractures in the emergency department and to determine if femoral nerve blocks can~     then be used to reduce the use of injected analgesia (anesthesia), therefore also causing~     fewer adverse effects associated with injected analgesia (such as bruising at the site of~     injection).~      100 patients with hip fractures will be enrolled in the study. Patients will be randomly~     assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care~     (SC), which is injected analgesia alone.~      Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine~     (a local anesthetic of long duration) injected into the front of the thigh, at the site of~     pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so~     that no neither the patient or the treating physician knows to which group the patient was~     randomized. All blocks will be performed in the emergency department by an emergency~     physician trained in the use of ultrasound and ultrasound guided nerve blocks.~      Subjects will be asked to rate their pain on a numeric pain scale both before and after~     intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is~     in the ER still). Additional data to be collected includes demographics, vital signs, and~     course of treatment resulting from the ED visit.~      Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly~     decrease or eliminate the need for narcotics.~   "
105205|NCT01680094|"~     The purpose of this study is to assess the safety and ability of panobinostat to re-activate~     HIV transcription in latently infected CD4+ T-cells among HIV-infected patients on stable~     antiretroviral therapy~   "
103575|NCT01701388|"~     This study seeks to test the safety and efficacy of the Esko device in SCI population and in~     populations with similar neurological weakness to the SCI population. The device can~     currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as~     follows:~        -  Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance~          while wearing the device as noted by subject's ability to safely achieve standing~          balance for 30 sec without loss of balance.~        -  Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to~          safely ambulate 10 meters to be assessed using the 10 meter walk test.~        -  Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift~          in both static and dynamic activities as determined by a trained physical therapist.~        -  Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with~          training of the device as noted by subjective questionnaires that will be assessed~          following each training session.~   "
103576|NCT01701375|"~     1.1 Primary Objectives~        -  To determine the feasibility, tolerability, and toxicities of administering the~          selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and~          Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk~          myelodysplasias (MDS), including primary refractory disease~        -  To determine the direct cytotoxic effects of single agent PD 0332991 on malignant~          blasts~        -  To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential~          combination with ara-C and Mitoxantrone~        -  To determine if the timed sequential combination of PD 0332991 with ara-C and~          mitoxantrone can induce clinical responses in adults with relapsed or refractory acute~          leukemias and high-risk MDS~      1.2 Secondary Objectives:~        -  To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell~          populations in vivo~        -  To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest~          malignant cells in the G 1 phase of cell cycle, followed by synchronized release of~          those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced~          ara-C cytotoxicity~   "
103577|NCT01701362|"~     This study is designed to investigate if pregabalin is effective in treating neuropathic~     (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event~     such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement,~     hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.~   "
103578|NCT01701349|"~     This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin~     given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with~     chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC).~     The primary objective of the study is to determine overall survival. A maximum of 300~     subjects will be recruited from approximately 75 multinational sites of which approximately~     35 will be located in the United States.~   "
103579|NCT01701336|"~     The purpose of this study is to determine whether administration of recombinant IMPs~     Ad6NSmut and MVA-NSmut (experimental vaccines for hepatitis C) in HCV chronically infected~     patients in combination with the standard Interferon/ribavirin therapy is safe and induces~     an immunological response.~   "
103580|NCT01701323|"~     This pilot clinical trial studies infusion of laboratory-grown donor cord blood cells~     following combination chemotherapy in treating younger patients with acute myeloid leukemia~     that has returned or that does not respond to treatment. Chemotherapy drugs work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy~     infection-fighting cells, increasing the risk of infection. The infusion of laboratory-grown~     cord blood cells may be able to replace blood-forming cells that were destroyed by~     chemotherapy. This may decrease the risk of infection following chemotherapy, and allow for~     more chemotherapy to be given so that more cancer cells are killed.~   "
103581|NCT01701310|"~     116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia~     will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric~     carboxymaltose (intervention).~      It is hypothesized that intravenous iron supplementation is more efficacious than oral iron~     therapy.~   "
103582|NCT01701297|"~     Research question: Do oral probiotics in patients with cirrhosis and ascites reduce~     intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to~     antibiotics or placebo?~      This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of~     healthy bacteria for the intestines) compared to an antibiotic or placebo in preventing~     infection developing in the abdominal fluid (ascites) that collects in patients with~     advanced liver disease (cirrhosis). Patients already having had infection will be excluded~     from the study. Clear inclusion and exclusion criteria will be met and patients will be~     monitored throughout the study to examine whether they have required more hospitalisations,~     their rate infection in abdominal fluid or elsewhere and the level of liver function.~   "
103583|NCT01701284|"~     Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is~     associated with high rates of depression and anxiety among its sufferers, and cancer~     patients with depression usually have worse treatment outcomes and long-term survival.~     Surprisingly, many cancer patients with depression do not receive treatment for their~     depression, perhaps because treatments for cancer-related depression are usually adapted~     from those used in non-cancer populations and may not be suitable for cancer patients.~     Moreover, cancer patients with depression are more likely to have a long latency of~     anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and~     an increased susceptibility for systemic side effects. Repetitive transcranial magnetic~     stimulation (rTMS) is a new treatment modality for depression that affects the brain~     directly with no systemic side effects and poses no potential for drug-drug interactions.~     rTMS therapy was recently cleared by the FDA as an antidepressant treatment for~     treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array~     of additional psychiatric indications. This randomized, open label, two-arm, pilot study~     will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS~     (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study~     hypotheses are that rTMS will significantly reduce symptoms of depression and that~     right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of~     severe anxiety.~   "
103585|NCT01701258|"~     Severe childhood adversity, including childhood sexual abuse (CSA), explains 32-44% of~     psychiatric disorders and is associated with substantially increased risks for depression~     and substance abuse later in life. However, 20-40% of adults with a history of CSA report~     little to no consequences. The neurobiological underpinnings associated with adaptive~     (resilience) and maladaptive consequences of CSA remain largely unknown. The goal of this~     study is to investigate brain pathways within adult females (with a history of CSA that~     occurred between the ages of 5-9) with and without a current diagnosis of major depressive~     disorder (MDD). We hypothesize that the CSA/MDD participants will be characterized by (1)~     reduced reward responsiveness and prefrontal cortex activity, but increased cortisol levels,~     (2) reduced dopamine activity, and (3) reduced dopamine transporter binding. The~     over-arching purpose of the study is to (1) identify individuals at risk for psychopathology~     and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted~     therapeutic interventions.~      This study involves 4 sessions, described below.~      Session 1 (SCID Session) The first session takes place at the Center for Depression,~     Anxiety, and Stress Research (CDASR) or Neuroimaging Center (both at McLean Hospital) and~     involves consenting, a clinical evaluation, a series of questionnaires, and a medical~     assessment.~      Session 2 or 3 (fMRI Session) The third session takes place at the Neuroimaging Center.~     Using a double-blind design, participants will be administered either amisulpride (50 mg) or~     placebo. Participants will complete the Monetary Incentive Delay (MID) task during~     functional magnetic resonance imaging (fMRI) and the Probabilistic Stimulus Selection Task~     (PSST) afterwards.~      Session 2 or 3 (PET Session) This session takes place at Massachusetts General Hospital. 9~     mCi of [11C] altropane will be injected by a trained nuclear medicine technician and~     positron emission tomography (PET) scanning will begin. Prior to the PET scan, a blood serum~     pregnancy test will be administered for females.~      Session 4 (ERP Session) The fourth session takes place at the CDASR and involves an~     electroencephalography (EEG) recording, the Probabilistic Reward Task (PRT), and collecting~     saliva samples to assess cortisol levels.~   "
103586|NCT01701245|"~     Subjects enrolled into this 10 week study will for the first two weeks document the number~     of cluster headaches and the means of treating (medication) of these attacks. Subjects will~     then be randomized to into either two groups. The first group is continuing with standard of~     care and the second group is treatment with the investigational device (GammaCore) for a~     period of 4 weeks. After this 4 week period, all subjects will treat with the GammaCore for~     another 4 week period. It is hypothesized the the treatment group will have a reduction in~     mean cluster headaches per week by 50% compared to the standard of care group.~   "
103587|NCT01701232|"~     This international multi-center, randomized, controlled, open-label study will investigate~     the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (NN: rituximab, CJSC~     Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a~     monotherapy of patients with indolent non-Hodgkin's lymphoma.~      Patients will be randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week~     for 4 weeks or MabThera at the same regimen.~   "
103588|NCT01701219|"~     This is a study of safety and efficacy of ceftaroline fosamil in Subjects with~     Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA)~     Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.~   "
103589|NCT01701206|"~     This study seeks to determine whether social networking technologies can be used to increase~     HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply~     a diffusion of innovations style intervention to social media to increase HIV testing.~   "
103590|NCT01701193|"~     The purpose of this study is to determine whether an amino acid is an effective treatment to~     prevent abdominal/pelvic scar tissue.~   "
103591|NCT01701180|"~     Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin~     has prosocial effects. However, the neural substrates of these effects are still unclear.~     The investigators hypothesized that a single dose administration of oxytocin should increase~     empathogenic and affiliative responses and that these effects are mediated by an increased~     insula activity.~   "
103592|NCT01701167|"~     The purpose of this study will evaluate new technologies that have been included in the new~     PCA-9000A PET/CT System.~   "
103593|NCT01701154|"~     The purpose of the study is to determine if respiratory muscle strength training will be~     beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe~     disease.~   "
103594|NCT01701141|"~     Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to~     modulate behavior as a function of rewards. However, the neurobiology of anhedonia and~     reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a~     critical role in goal-directed behavior and reinforcement learning, DA dysregulation might~     play an important role. In fact, several lines of evidence suggest that down-regulation of~     DA transmission might characterize depression vulnerability and the emergence of depressive~     symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We~     hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward~     learning in the probabilistic reward task, and abnormal functional magnetic resonance~     imaging (fMRI) activation in dorsal and ventral striatal regions during an instrumental~     learning task.~      This study will include three sessions.~      The first will take place at Massachusetts General Hospital or at McLean Hospital's Center~     for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain~     the study; (b) collect written informed consent, and (c) assess the subject's eligibility.~      Following this, another session (either second or third in order) will take place at the MGH~     PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward~     task designed to measure reward learning and sensitivity to reward. The radioactive tracer~     utilized is 11C-altropane.~      Another session (either second or third in order) will take place at the McLean Hospital~     Neuroimaging Center. Participants will complete an instrumental learning task while in the~     fMRI, followed by a social reinforcement learning task and an implicit learning serial~     reaction time task upon completion of the scan. In the instrumental learning task,~     participants have the opportunity to earn money but need to learn, by trial and error,~     stimulus-outcome associations. The social reinforcement learning task is designed to~     investigate whether learning deficits in MDD are specific to learning from monetary~     incentives or whether the learning deficits are more global and are affected when learning~     from social rewards and punishments. Participants will also complete an implicit learning~     serial reaction time task, designed to exclude the possibility of global learning deficits~     in MDD.~   "
103595|NCT01701128|"~     The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and~     without a strengthening component, on functional mobility, gait and quality of life in~     patients with Parkinson's disease (PD). The rationale for a study of this type stems from~     the hypothesis that treadmill training may act as an external pacemaker and enhance some~     properties of gait. There is a need for larger scale randomized controlled trials comparing~     the effects of treadmill training to control groups that receive similar amounts of~     attention. To date, no study has combined TT and muscle strengthening, likely the optimal~     form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of~     72 one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill~     training will considerably improve walking parameters and the well being of people with PD.~   "
103596|NCT01701115|"~     The purpose of this study is to determine if a decrease in the standard volume of local~     anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate~     anesthesia for the procedure and decrease the amount of time until you are ready for~     discharge from the hospital.~   "
117349|NCT01520012|"~     The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808~     100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.~   "
103599|NCT01701076|"~     Almost all patients with multiple myeloma who survive initial treatment will eventually~     relapse and require further therapy.~      Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large~     randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months~     for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior~     therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone~     until disease progression is therefore considered a standard therapy for second line~     treatment in multiple myeloma patients. However, only a relatively low rate of high quality~     response (CR, complete response and VGPR, very good partial response) is achieved. High~     quality responses are associated with with improved progression-free survival and overall~     survival [4].~      Trial: The aim of this trial is to improve high quality response rates for patients with~     relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be~     achieved by the addition a third anti-myeloma drug (bendamustine) to the established~     backbone of lenalidomide/ dexamethasone.~      Treatment regimen:~        -  Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide~          25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.~        -  Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg /~          20mg (for patients > 75 years) d 1, 8, 15, 22.~      Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is~     mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe~     neutropenia.~      The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this~     aim is achieved, the treatment of bendamustine in combination with the established~     lenalidomide/ dexamethasone regimen will be considered promising.~      Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.~   "
103600|NCT01701063|"~     The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a~     carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a~     telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.~   "
103601|NCT01701050|"~     Utilizing CellSearch® technology, the ability to both enumerate and reliably and~     reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict~     endocrine sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has~     been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been~     constructed that can be calculated for each patient using the CTC enumeration and marker~     results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2~     negative metastatic breast cancer patients before the initiation of a new endocrine therapy~     for the identification of patients that will progress rapidly.~   "
103602|NCT01701037|"~     This phase II trial studies how well giving dabrafenib alone and in combination with~     trametinib before surgery works in treating patients with advanced melanoma that can be~     removed by surgery. Studying samples of tumor tissue in the laboratory from patients~     receiving dabrafenib and trametinib may help doctors learn more about the effects of these~     drugs on cells and help identify biomarkers that determine which patients will respond to~     these drugs best.~   "
103603|NCT01701024|"~     The primary objective of this study is to compare the efficacy and safety and tolerability~     of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.~   "
103604|NCT01701011|"~     Background of the study:~      Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman~     and her partner. Most stressful for the couple is waiting for the result of the treatment,~     the period after the embryotransfer until the pregnancy test or menstruation and an~     unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples~     during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp~     copingintervention has been developed based on the stress theory of Lazarus for women to use~     at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal.~     Research has demonstrated that using this copingstyle can have a positive impact in health~     related circumstances.~   "
103605|NCT01700998|"~     Acute renal failure (ARF) is a serious and common complication in hospitalized patients,~     occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common~     disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60%~     in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and~     patients with mild hypomagnesemia do not need treatment, only the correction of the~     underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is~     associated, in humans, with acute renal failure. To date, there is no study that~     demonstrated a benefit of maintain normal levels of magnesium in the incidence of ARF in~     critically ill patients. Thus, we suggest that a treatment aimed to maintain normal~     magnesium levels during ICU stay can decrease the incidence of ARF. We will perform a~     randomized clinical trial that will include all patients admitted to an ICU that, develop~     hypomagnesemia. It will be excluded from the study: patients younger than 18 years,~     participants from other studies, pregnant women, patients with creatinine greater than or~     equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological~     studies, patients weighing less than 40kg, suffering from advanced malignant disease, with~     severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), with a diagnosis~     of Torsades de Pointes or symptomatic hypomagnesemia prior to randomization. Patients~     included in the study will be randomized to one of the following groups: placebo (saline~     solution 0.9%) or 50% Magnesium Sulfate. Patients will receive an administration of 48 mEq~     Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate of 10.4 ml / hr.~     Therapy will be continued for 3 days, and repeated during ICU stay to maintain magnesium~     levels in the normal range. Placebo group will receive exactly the same infusion only with~     saline administration. The therapy will be discontinued if the patient has hypermagnesemia~     or signs of magnesium intoxication. The main outcome measurement will be the occurrence of~     ARF during ICU stay.~   "
103606|NCT01700985|"~     Corticosteroids are one of the mainstays of treatment for subjects with~     corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to~     determine and compare the efficacy and safety of a formulation of 122-0551 versus the~     corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for~     14 consecutive days.~   "
103607|NCT01700972|"~     The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45~     minutes after radiotracer injection, for both rest and stress studies. We hypothesize that~     early imaging 10 minutes after radiotracer injection provides high image quality and~     diagnostic accuracy comparable to 30-45 minutes MPI.~   "
103608|NCT01700959|"~     Primary objective:~        1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult~          survivors of childhood cancer.~      Secondary objectives:~        1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in~          long-term childhood cancer survivors.~        2. To investigate whether improvement in sleep onset latency due to melatonin treatment is~          associated with neurocognitive improvement in long-term childhood cancer survivors.~      This study is a randomized double-blind placebo controlled trial of time release melatonin~     for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning~     and/or difficulty falling asleep.~   "
103637|NCT01700569|"~     O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced~     by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al~     published regimen. In preclinical models, it has been demonstrated that MGMT methylation~     (which is silencing the DNA repair process) is achievable by folic acid. About half of the~     patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer~     prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic~     acid in combination with temozolomide and radiotherapy of operated GBM.~   "
103609|NCT01700946|"~     The overall objective of this protocol is to improve the cure rate of relapsed precursor~     B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma.~      This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or~     lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive~     different therapy. Treatment will consist of chemotherapy for SR participants, and~     chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse.~     Induction therapy consists of three blocks of chemotherapy. The first block is a novel~     immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical~     natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total~     duration of approximately 2 years. HR participants will be candidates for HSCT and will~     proceed to transplant once a suitable donor is found and their minimal residual disease~     (MRD) is negative.~   "
103610|NCT01700933|"~     Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability.~     The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a~     well-documented effect on pain and function in patients with osteoarthritis of the hip. It~     is sought an optimal dose of exercise, in which this study will help to investigate.~      We hypothesize that an exercise program designed to have a high number of repetitions will~     benefit the outcome of the training in a more positive way than a low-repetition based~     program.~   "
103611|NCT01700920|"~     The purpose of this study is to analyze the safety and feasibility of direct administration~     intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of~     patients with femoral osteonecrosis.~   "
103612|NCT01700907|"~     Various issues had been pointed out when undergoing the anesthesia for elderly patients with~     sevoflurane, such as delayed emergence, post-operative trouble with swallowing.~      Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the~     better emergence, along with the recent progress on optimization of delivered amount of~     anesthesia.~      The purpose of this study is to compare the time to emergence in long elderly patient cases~     with desflurane or sevoflurane, with the recently developed drug-delivery optimization~     system Aisys® (GE Healthcare Japan).~   "
103613|NCT01700894|"~     African American (AA) women have the lowest physical activity (PA) levels, which contributes~     to substantial disparities in cardiovascular health and depressive symptoms. There is a need~     to examine ways to promote PA that are appealing, applicable to clinical practice, and~     cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's~     Walking Program (WWP), consisting of a lifestyle PA prescription and group visit delivery~     model, with or without tailored telephone contacts between group visits for increasing~     adherence to PA and improving health outcomes. Two telephone contact strategies will be~     compared against a no-telephone control condition: a person-administered contact strategy~     using brief motivational interviewing and an automated contact strategy using a telephone~     computer-linked system. Group visits and telephone contacts are designed to increase~     adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over~     baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and~     longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered~     telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone~     contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic~     fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in~     one's ability to be physically active) and outcome expectations (expected benefits to being~     more active); and (2) to compare cost-effectiveness of the three telephone treatment~     conditions in relation to adherence to lifestyle PA and health outcomes.~      The investigators will randomly assignment of the order of administering the three~     conditions to six community health care sites. These six sites are similar with respect to~     race, socioeconomic status, and residential mobility. The study will include 288 sedentary~     AA women aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease~     (CVD); no history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP <~     160/100.~      Initial screening will occur in person or over the phone. Further screening at the data~     collection site with an advanced practice nurse will include blood work for glucose and~     lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all~     women who are eligible will: be given questionnaires on physical activity, health and~     factors that influence their physical activity; have their height, weight, waist~     circumference measured; and do a two minute step test. All three treatment group will attend~     5 group visits every 5 weeks during adoption (first 24 weeks) and 1 booster group visit~     during maintenance (week 36). The group visit consists of brief individual time with a staff~     member followed by a group visit with motivational videotapes. All treatment groups will~     self-monitor their physical activity with accelerometers and enter their step data into a~     voice response system.~      The groups receiving the automated telephone contact strategy and the group receiving the~     person telephone contact strategy will have the same number and spacing of the telephone~     contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks~     between group visits during adoption and two telephone contacts [weeks 28, 43] during~     maintenance). Using motivational interviewing, a nurse will tailor the telephone discussion~     to the person telephone contact group to match the participant's needs, experiences,~     barriers, motivation, and confidence. Women in the automated telephone contact group will~     receive an automated call with feedback on their progress based on the information they~     reported into the ATCL system. The automated telephone contact system will deliver feedback~     on progress, problem solving, goal-setting, and support. All information will be delivered~     in the voice of one of our staff members. The third treatment group will receive no~     telephone contacts between group visits.~      Potential risks exist for women who have medical problems, which contraindicate physical~     exercise. Additional risks associated with the walking program include safety and injury.~     There are potential risks of infection at the site of the one time finger blood withdrawal.~     Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body~     composition and blood pressure and fewer symptoms. The subjects will be given a physical~     activity prescription that should benefit them through life and decrease their risk for CVD.~      Women will be recruited throughout the West and South side of Chicago. They will give verbal~     consent at the screening questionnaire and sign an informed consent at the time of the~     screening history and physical. They will be told that participation is voluntary, they may~     decline or withdraw at will at any time, and all results will be held strictly confidential.~   "
103614|NCT01700881|"~     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a~     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a~     control supplement or a placebo. The principal measure is pain as measured by Visual Analog~     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,~     respectively. The study duration is 36 weeks.~      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified~     as triggers improves mood, using the Center for Epidemiologic Studies Depression~     Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).~   "
103615|NCT01700868|"~     This study aims to test hypotheses that are potentially important to diabetes management,~     with practical implications for reducing the medical, personal, and economic costs of the~     disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are~     significantly greater than those achievable with current diet recommendations, reductions in~     medication use among many intervention-group participants, beneficial changes in body weight~     and serum lipid concentrations, and a demonstration of the acceptability of the intervention~     diet. Progress toward these goals could refine dietary guidance for individuals with~     diabetes, increase treatment expectations, and reduce the massive burden the disease~     currently imposes.~      The study further attempts to translate a dietary intervention studied in a clinical~     research setting to a medical practice. This will contribute to developing a model for~     diabetes care that can be used widely.~   "
103616|NCT01700855|"~     The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in~     patients undergoing selective nasal sinus surgery and mammaplasty.~   "
103617|NCT01700842|"~     Approximately 3,000 of clinically significant isolates of different species from respective~     respective sources in geographically distinct Russian cities will be collected and tested on~     ceftaroline and other antimicrobials.~   "
103618|NCT01700829|"~     This study is designed to compare the effectiveness of two medications, Ketamine and~     Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.~      The first drug, Ketamine, is an experimental antidepressant that early studies have shown~     may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam,~     the comparison drug, is not thought to reduce depression or suicidal thoughts.~   "
103619|NCT01700816|"~     The purpose of this study is to find out if using bright light sessions during bone marrow~     transplant can prevent people from developing confusion also known as delirium.~   "
103620|NCT01700803|"~     The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by~     Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section~     wound infections & compare side effects of both agents.~   "
103621|NCT01700790|"~     The object of this study is to evaluate the pharmacokinetic interactions, short term safety~     and efficacy of standard dose lopinavir/ritonavir 200mg/50 (two tablets twice daily) given~     with ritonavir 100 mg three tablets twice daily given in combination with rifampin in~     HIV-infected persons with tuberculosis~   "
103622|NCT01700777|"~     A randomized control trial of HABIT-ILE therapy compared with regular / conventional~     intervention (same amount of hours). The protocols have been developed on the basis of~     bimanual therapy (HABIT) developed at Columbia University.~   "
103623|NCT01700751|"~     This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab~     vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem~     cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or~     myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and~     methotrexate may result in a significant reduction of graft versus host disease in these~     patients.~   "
103638|NCT01700556|"~     The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease~     patients through the integration of services and the use of new TECHnologies in order to~     also improving the quality of life of their family caregivers.~   "
104150|NCT01693835|"~     Observational, non randomized study aimed at measuring the circadian rhythms in the urinary~     concentrations of physiological modified nucleosides in 30 patients with metastatic~     colorectal cancer and in 30 age and sex-matched healthy subjects.~   "
103624|NCT01700738|"~     MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with~     conventional treatment of obesity.~      SECONDARY OBJECTIVES~        -  Compare the effects of the placement of a gastric band with conventional treatment of~          obesity on quality of life, body composition and parameters of the metabolic syndrome.~        -  Identify predictors of good answer to the ring to determine the best future~          indications.~        -  Study of the gastric tolerance.~      INCLUSION CRITERIA~        1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is~          greater than IMCZ-score > 4 DP> 8 kg~        2. Obesity common non-syndromic.~        3. Medical decision of surgical placement of laparoscopic gastric banding.~        4. Adolescent and family who understand and accept the need for medical and surgical~          follow long term.~        5. Adolescent and family who fully understood the oral and written information explaining~          the study and the need for prolonged follow-up.~        6. Obtention of oral and written consent of the adolescent and the parents.~        7. Parents and adolescents affiliated with the social security system.~      NONINCLUSION CRITERIA~        1. Intellectual Deficit.~        2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.~        3. Obesity with severe binge eating.~        4. Pregnancy or wishes of pregnancy in the following year.~        5. Non accession adolescent and / or family in the process of medical care before~          inclusion.~        6. Predictable post surgical monitoring difficulties.~        7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.~        8. Participation in a clinical study evaluating a treatment during the 2 years of the~          study.~      EXCLUSION CRITERIA~        1. Anesthetic contre indication for placement of a gastric laparoscopic.~        2. IMC> 50 kg/m2 the day of inclusion.~      STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient~     and his family. Patients will then be enrolled and randomized. Patients in group A (surgery~     group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in~     group B start conventional monitoring dietary medical and physical. For both groups~     follow-up visits will occur every 3 months for 2 years.~   "
103625|NCT01700725|"~     The purpose of this study is to determine whether nasal irrigation with Xylitol or saline~     are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated~     with Gulf War Illness.~   "
103626|NCT01700712|"~     The increasing interest in probiotic lactobacilli in health maintenance has raised the~     question of potential risks. One possible side effect could be an increased acidogenicity in~     dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli~     on plaque lactic acid (LA) production in vitro and in vivo.~      Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM~     17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over~     trial. The concentration of LA in supragingival plaque samples was determined at baseline~     and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were~     estimated with chair-side methods.~   "
103627|NCT01700699|"~     -  Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer~          (DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors~          (TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC~          (MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists~          of a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of~          BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be~          responsible of the frequent defeats of this treatment. A therapeutic strategy based~          upon BRAF inhibitors in tumors bearing subclonal BRAFV600E could be initially~          successful hitting the tumor cells expressing the oncogene, and after the initial tumor~          growth arrest and/or shrinkage, the oncogene negative cells insensitive or less~          sensitive to the treatment, could restart the growth of the tumor causing the~          progression of the disease and the escape from the clinical response.~        -  Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors~          in the treatment of MRR-DTC.~        -  Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by~          pyrosequencing or other quantitative assay. If available, synchronous metastases and~          post-therapy metachronous metastases will be analyzed as well. The clinical response~          will be determined according to RECIST, and the association with the percentage of~          BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference~          of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases,~          primary tumors and post-therapy metachronous metastases, and between responsive and~          resistant synchronous tumor lesions.~   "
103628|NCT01700686|"~     The overall purpose is to explore the link between the gut and the bones by investigating~     meal stimulated changes in the blood level of a number of hormones and markers related to~     intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric~     bypass). The hormones will be measured in blood samples taken before and after surgery. The~     results are compared with changes in body weight and body composition as measured by DEXA~     scanning.~   "
103629|NCT01700673|"~     To determine the impact of maintenance therapy in patients with MDS/AML in remission.~   "
103630|NCT01700660|"~     Major liver surgery often requires the surgeon to temporarily halt the afferent blood flow~     in order to prevent excessive blood loss. However, this predisposes the liver to a~     detrimental inflammatory response once the circulation is restored. Altogether, the effects~     that result from this temporary withdrawal of blood are known as ischemia and reperfusion~     (I/R) injury, and the extent to which this occurs determines the functional outcome of the~     liver after surgery.~      Recently, it has become clear that (over)activation of the immune system forms the mainstay~     of I/R injury in the liver. More importantly, it has been shown in animal models that~     self-antigens, which are normal cellular constituents that become immunogenic mediators~     following their release from dying cells, are involved in the earliest stages of I/R injury~     of the liver. Clinical data on the release self-antigens in I/R injury are however scarce to~     date. Therefore, the aim of this study is to investigate the release of self-antigens in~     patients that undergo a major liver resection with or without withdrawal of the liver's~     blood flow. Also, the results will be correlated to genes involved in the inflammatory~     response as well as clinical parameters for liver damage and function.~   "
103639|NCT01700543|"~     This post market clinical follow-up study is designed to confirm safety and performance of~     the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.~      The safety of the implant will be evaluated by monitoring the frequency and incidence of all~     kinds of adverse events.~      The performance will be determined by analyzing the implant survival, overall pain and~     functional performances (based on Constant & Murley score and ASES score), subject quality~     of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis,~     component migration) of study subjects who received the Sidus Stem-Free Shoulder.~      The Sidus Stem-Free Shoulder is not approved for use in the US.~   "
103640|NCT01700530|"~     Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic~     syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk~     factors. We also examined if statins impacted exercise response for mitochondrial content in~     muscle or aerobic fitness.~   "
131926|NCT01328418|"~     The purpose of this study is to determine whether lengthening of both the tibiae and femora~     in achondroplastic patients is safe and provides reproducible outcome.~   "
103631|NCT01700647|"~     It is possible to test a sample of breath from a patient, run it through a machine, and find~     out certain diseases in the patient without needing to do Xrays. It is sort of like~     abreathalyser.In the future it is hoped this type of testing will be common, and allow~     certain conditions to be picked up early. One of these conditions is Cancer of the Larynx~     (voice box). It is not in wide use yet however a study has shown it is very effective in~     detecting Larynx cancer.~      This breath test has detected cancers at a stage when they CAN be seen on Xrays or looking~     in with cameras. However the larger the cancer ultimately the worse it is for the patient.~     It would therefore be much better to have the breath test find patients with cancers at a~     much smaller size. It is interesting that the cancers which the breath test HAVE found all~     have the same breath test signal, regardless of size. This means even smaller cancers may~     have the same signal. These small cancers are only 1-2 mm thick, and when found at this size~     almost all can be cured. We want to find a group of patients who have these early cancers~     and compare it to breath test result in patients who have large obvious cancers. These~     patients will be compared to other patients who have are negative for larynx cancer who also~     have a breath test. We want to prove that their breath test will be negative.~      You have been referred either because you have symptoms (such as cough or hoarse voice) and~     need a scope to look into the airways, OR your specialist has identified a spot on the~     larynx which needs a biopsy (sample) and then possible treatment, The spot may or may not be~     cancer- that is why the biopsy is needed. After that the correct treatment would be~     considered depending on the result, that is, whether it is a cancer or not. If possible we~     would like to take a test of your breath before the biopsy. Alternatively we can take a~     breath test 2 weeks after a biopsy.~      In summary this study is trying to show whether the breath test is the same in patients who~     have large cancers as patients with small cancers invisible on XRay and only found with~     careful magnification by scopes looking in. If we can show these findings it will~     demonstrate great potential for the breath test to find many more cancers which are truly~     curable.~   "
103632|NCT01700634|"~     The aim of this project is to investigate fMRI ability to identify pain central~     sensitization in chronic knee OA. Patients with high and low central sensitization and~     healthy control subjects will be included. Central sensitization will be clinically defined~     based on the evidence of regional spread of pain (spreading sensitization) and increased~     pain response to repeated stimulation (temporal summation). Operatively, a patient will be~     assigned to high sensitization group when showing (i) clinical evidence of pain or altered~     sensations spread beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical~     sites around the knee showing a pressure pain threshold below 4 kg/cm2 (tender points),~     (iii) pain score of 4 points or more in a 11-point scale during 4 kg/cm2 pressure~     stimulation on the anterior/medial surface of the tibial bone (the site selected for the~     fMRI experiment) and (iv) increase of at least 1 point in a 11-point scale after 10 repeated~     pressure stimulation on the tenderest point around the knee.~      A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain~     response to direct pressure stimulation on the painful knee, which will reflect the~     combination of peripheral and central sensitization; (ii) brain response to pressure~     stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia),~     which will mostly reflect central sensitization mediated at the spinal cord level, and (iii)~     brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar~     forearm), which will reflect central sensitization occurring in the brain and involving the~     highest-level pain modulatory mechanisms. An additional evaluation is proposed using~     resting-state fMRI to assess potential alterations in baseline brain functional~     organization.~   "
103633|NCT01700621|"~     The investigators aim to establish the non-inferiority of concomitant administration of~     measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of~     measles seroconversion rates. The primary study hypothesis is the measles seroconversion~     rate as defined by the percentage of children seroconverting to measles with a measles serum~     antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant~     administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained~     when measles-rubella vaccine is given alone in children 9 months of age who have received a~     primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second~     at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination~     sample.~   "
103634|NCT01700608|"~     Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell~     (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The~     'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may~     be more efficient and cost-effective, but the timing of administration and criteria for~     patient selection are still under investigation. We collected the data of lymphoma and~     myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy +~     G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of~     hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt,~     according to the attending physician choice. The primary endpoint was the assessment of the~     rate of patients who were able to collect >=2 x 10^6 CD34+/kg.~   "
103635|NCT01700595|"~     Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental~     effects on functional, physical and psychological development of children. Perforator flaps~     have already been shown to be reliable options for the reconstruction of contractures but~     there have been no reports demonstrating the value of preexpanded perforator flaps of~     dorsolateral trunk region in treatment of extensive contractures and scars of pediatric~     patients. The purpose of this study is to demonstrate these techniques by a case series~     formed of pediatric patients with broad scars and contractures of anterior chest wall,~     axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated~     by preexpanded perforator flaps are presented. By this means, clinical experience on~     intercostal artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap,~     circumflex scapular artery perforator (CSAP) flap and lumbar artery perforator flap was~     shared. Flaps as large as 20,5x10,5 cm in size could be successfully transferred in~     pediatric patients. Broad scar tissues were resurfaced with broad flaps carrying similar~     characteristics with the uninjured anterior chest wall and neck skin in six of our patients.~     In one patient with partial necrosis, full thickness skin graft was used for the residual~     defect. The mean duration of postoperative (after flap transfer) follow-ups was 17,2 months.~     The preexpanded TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options~     for the treatment of scars and contractures of anterior chest wall, axilla, neck and breast~     in pediatric patients.~   "
103636|NCT01700582|"~     The French National Cancer Institute (INCa) support a 28 hospital platforms network for~     molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers~     in order to speed up access of French cancer patients to targeted therapies (commercially~     available or through clinical trials).~      The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical~     and molecular characteristics of these patients and their tumors and to assess the impact of~     these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response~     rate, progression free and overall survival).~   "
103641|NCT01700517|"~     Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries~     performed per year in the United States, with a 673% increase estimated until 2030.~     Functional and pain management improvement is expected in 90% of patients, with 85% of them~     satisfied after the procedure.~      Immediate postoperatory pain control is an important aspect to be considered. Patients~     submitted to TKA endure pain with variations between 40-80 (according to analog visual scale~     -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in~     the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients~     submitted to TKA during this period of time. Therefore adequate pain management allows an~     earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization~     period.~      A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2~     anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics~     injections and decrease use of opioids given of potential collateral effects. Peripheral~     blockings are associated to the smallest rate of collateral effects and complications when~     compared to the spinal anesthesia and analgesia controlled by the patients. Studies~     comparing the effects of the femoral and sciatic-femoral blocking guided by ultrasonography~     for the analgesia control after TKA were not found.~      The objective of this article is to evaluate the effect of femoral and sciatic-femoral block~     using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients~     submitted to TKA, opioid consumption and complications associated to anesthesics procedures.~   "
103642|NCT01700504|"~     The effect of axillary lavage with a gentamicin solution before wound closure will reduce~     the drainage volume and subsequently day of drainage removal.~   "
103643|NCT01700491|"~     Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior~     to epidural analgesia in terms of the main complication of hypotension.~   "
103644|NCT01700478|"~     This study was done to determine if the use of a combination of preoperative rectal~     misoprostol 400µg used with intraoperative perivascular vasopressin is better than~     perivascular vasopressin used alone to decrease bleeding at myomectomy.~   "
103645|NCT01700465|"~     Machine learning techniques and algorithms originally developed for use in the field of~     robotics can be applied to continuous, noninvasive physiological waveform data to discover~     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate~     acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict~     cardiovascular collapse well ahead of any clinically significant changes in standard vital~     signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be~     used to monitor volume loss during hemodialysis, as well as predict intradialytic~     hypotension, well before it occurs.~   "
103646|NCT01700452|"~     Early detection of lung cancer and early removal of the cancer nodules facilitates the~     diagnosis and treatment. However, not all nodules are malignant. Currently the standard~     method to diagnose lung cancer is to remove any suspicious nodules from the lung in a~     surgical procedure.~      This study is being conducted to evaluate the performance of a laboratory test to detect~     changes in lung cells that might be an early indicator of lung cancer. The test uses mucus~     (sputum) which is collected in a non-invasive method. This study will compare the results of~     the lung biopsy with the laboratory test to determine if the test can detect cancer or the~     lack of cancer.~      The laboratory test will not be shared with the treating physician or the patient as the~     current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be~     enrolled in the study. There is one visit involved and includes the collection of a sputum~     specimen by coughing into a cup. The medical records of patients who are negative for cancer~     by biopsy will be reviewed for 2 years to detect any changes in diagnosis.~   "
103647|NCT01700439|"~     The purpose of the clinical study is to prove that the heart valve device is safe,~     effective, and performs as intended.~   "
103648|NCT01700426|"~     The study addresses treatment of iron deficiency, the most common nutritional deficiency~     that infants and young children encounter. With the knowledge that iron deficiency may~     irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are~     offering free screening blood draws at Children's Hospital Colorado to older babies and~     toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15~     micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be~     invited to continue in the intervention portion of the study, where they will receive iron~     supplements as well as vitamin E (or placebo) for an eight week treatment period. The~     rationale for the study is to test whether addition of Vitamin E, an antioxidant and~     anti-inflammatory agent, improves the treatment response to supplemental iron.~   "
103649|NCT01700413|"~     While several studies have been reported with increasing doses of daunorubicin in the first~     line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with~     idarubicin as initial treatment of AML.~      As idarubicin is the most common treatment used for AML, it is needed to find the optimal~     dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination~     improves the outcomes of current treatments for AML.~      The aim of this dose-finding study is to find the optimal dose for the combination of~     idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and~     improve survival of patients with primary acute myeloid leukemia. This could be a~     significant advance in a field where treatment outcomes have stabilized in the last 15~     years. This study will be the basis for further prospective, randomized, multicenter trial~     comparing idarubicin maximum tolerated dose, compared to standard treatment with idarubicin~     and cytarabine, including raising both arms in G-CSF. The dose of 12 mg/m2 will be~     administered as control arm in this future randomized study, which will investigate the~     benefit of enhanced dose identified as optimal in this phase II pilot study.~   "
103650|NCT01700400|"~     The purpose of this study is to determine whether the investigational study drug everolimus~     may be used to increase the effectiveness of chemotherapy treatment for patients with~     advanced lung cancer.~   "
103651|NCT01700387|"~     The purpose of this study is to evaluate sustained tolerability, quality of life, and change~     in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs.~     OnabotulinumtoxinA and daily placebo (Group A vs. Group B).~   "
104472|NCT01689636|"~     Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of~     the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four~     subjects with known or suspected ovarian cancer.~   "
103653|NCT01700361|"~     This study will examine whether measurement of pelvic floor muscle sEMG activity is~     responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual~     arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be~     monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will~     also be required to provide subjective ratings of sexual arousal before and after each film.~     If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have~     important clinical and research implications by providing a greater understanding of the~     mechanisms involved in sexual arousal and for providing a relatively easy method of~     assessing sexual arousal in a clinical or research setting.~   "
103654|NCT01700348|"~     In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual~     Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and~     who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No~     Intervention group and will be given no test products or instruction other than to change~     none of their typical at home oral hygiene habits.~      The aim of this study is to investigate how an AF and MTB oral hygiene intervention will~     affect a population of irregular flossers using the residual protein concentration method as~     an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the~     Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices~   "
103655|NCT01700335|"~     The purpose of this study is to investigate tolerability when SyB L-1101 is administered~     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to~     determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the~     recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be~     investigated.~   "
103656|NCT01700322|"~     Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical~     outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group~     has shown that it can be improved by platelet inhibition using clopidogrel. However,~     clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial~     effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective~     anti-platelet therapy is able to prevent/improve not only thrombotic events but also~     endothelial dysfunction, with potential positive impact on clinical outcome in patients~     undergoing coronary artery stenting, is an important hypothesis that needs to be further~     investigated. To date, evidence regarding ancillary (non-platelet-dependent) effects of~     antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and~     their beneficial effects in patients with acute coronary syndromes, have been clearly~     demonstrated in multicentric trials, it remains to be shown whether these drugs also protect~     endothelial function. Interestingly, some authors suggest that the mortality benefit~     observed in the PLATO study is at least in part independent of direct antiplatelet effects.~     No study, to date, has tested the effects of prasugrel and/or ticagrelor on endothelial~     function. With the present trial, the investigators plan to test the effect of clopidogrel,~     prasugrel and ticagrelor on endothelial function before and up to 4 weeks after coronary~     artery stenting. This study will provide important pathophysiologic insight on the~     relationship between platelet aggregation and endothelial function, two parameters that have~     been shown to influence patients' prognosis.~   "
103657|NCT01700309|"~     The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen~     as one of the most important public health threats because of the significant impact of~     chronic conditions associated with obesity. Obesity during adolescence is a strong precursor~     of obesity and related morbidity in adulthood.~      Interventions aimed directly at reducing weight or preventing increase in weight shows~     limited results on long term effects and it is shown that increase in activity has more~     impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an~     appropriate measure of therapeutic interventions for growing children. The hypothesis of~     this study is that focusing on increasing meaningful physical activity through individual~     tailored counselling will have positive effects on the adolescents' fitness (health) and~     quality of life. Thus, the overall purpose of the study is to examine the extent to which a~     web-based intervention influences physical activity, fitness and quality of life in~     over-weight and obese adolescents Further, the aim is to explore and describe how~     adolescents experience being over-weight and obese, what they perceive as meaningful~     physical activity and finally how adolescents experience lifestyle changes as demanded in~     the intervention study.~   "
103658|NCT01700296|"~     Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is~     like any other with a chronic illness not only affected by the physical discomfort the~     illness gives. For COPD patients that is: accelerated loss of lung function, conditioning~     and increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months~     later.~      Patients are also characterized by various psychological factors such as reduced quality of~     life, depression, etc.~      Therefore, everywhere in the country newly diagnosed COPD patients are offered~     rehabilitation in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a~     week with physical exercise, smoking cessation, medication, nutrition education and~     psychosocial support and patient education based on the National Health Service and~     international recommendations.~      In the literature, the effect of rehabilitation on quality of life was measured using a~     questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function~     has been measured using a walk test, but there are no studies which look at the effect on~     inflammation lungs.~      It is important for COPD patients is to prevent exacerbations of the disease, which~     sometimes requires hospitalization and sometimes treated by their own doctor. It has been~     proven that inflammation in the lungs is associated with disease severity and exacerbation~     frequency, and therefore we would like to investigate whether both rehabilitation, close~     monitoring of patients with time in the pulmonary clinic every 3 months, and instruction in~     self-administration of medication (antibiotics and corticosteroids) have an effect on~     especially inflammation in the lungs, number of exacerbations, mortality, lung function and~     walking capacity.~   "
103703|NCT01699711|"~     Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to~     modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid~     beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse~     models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP~     functions is a therapeutic approach to improve cognitive performance and decelerate AD~     (Alzheimer's disease) like progression.~   "
103659|NCT01700283|"~     The aims of this four-year study are to~        1. Explore exercise behavior, exercise barriers, and identify the significant factors for~          exercise behavior in colorectal cancer survivors.~        2. Explore the relationships among fatigue, muscle strength, and metabolomics and further~          examine the possible biomarkers from muscle strength and metabolomics for fatigue.~        3. Develop a clinical guidelines of home-based fatigue management and exercise program and~          test its effect on decreasing fatigue for patients with colorectal cancer after surgery~          in Taiwan.~   "
103660|NCT01700270|"~     This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI)~     study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in~     patients with advanced solid tumors, excluding breast cancer. The purpose of this study is~     to evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib~     when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The~     study will consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase.~     The DDI test will be conducted in the PK phase. The DDI test will assess the steady state PK~     profile of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor,~     fluvoxamine (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase~     patients may continue to receive treatment with TKI258 until disease progression (assessed~     by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for~     any other reason.~   "
103661|NCT01700257|"~     Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is~     asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and~     already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals~     has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung~     cancer deaths are not prevented with LDCT screening alone.~   "
103662|NCT01700244|"~     An evaluation of a safety and performance of a new cardiac pacemaker~   "
103663|NCT01700231|"~     Introduction Liver resection is considered the only curative treatment option for mCRC~     patients without extrahepatic disease and is accepted practice. Despite substantial~     improvements in surgical techniques, postoperative morbidity and mortality remain an~     important concern after major resections. Complications of liver resection, although rare,~     include liver failure and acute kidney injury as indicated by oliguria and increased serum~     creatinine. The underlying pathophysiological pathways of post-operative renal alteration~     following liver resection is an increase in portal venous pressure, based on observations in~     animal models or small cohorts. The corpus of data is derived from patients with liver~     cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot~     distinguish between metabolic changes, portal hypertension and impaired liver function in~     the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a~     potent model to evaluate the impact of portal hypertension on the kidney despite stable~     liver function.~      The most significant factor determining morbidity and mortality following hepatectomy is the~     ability of the remnant liver to regenerate. In this context, several growth factors were~     shown to regulate the highly orchestrated process of liver regeneration (LR).~      Hypothesis The investigators will therefore test the hypothesis that liver resection leads~     to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal~     impairment, correlating with the quantity of resected liver.~      Furthermore, the investigators will examine the relationship between postoperative liver~     regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based~     on the preclinical data the investigators hypothesize that a circulating growth factor~     levels will be associated with delayed liver regeneration, an increased incidence of~     postoperative liver dysfunction and concomitant worse clinical outcome.~   "
103664|NCT01700218|"~     The purpose of the study is to test a new medical device for optimizing treatment of heart~     failure and compare its effect on outcome of patients with a recent hospitalization for~     worsening heart failure~   "
103665|NCT01700205|"~     The overarching goal of the research we propose here is to conduct a randomized clinical~     trial to specify the physiologic and behavioral mechanisms by which infant-formula~     composition affects all aspects of energy balance and growth during the first years of life.~   "
103666|NCT01700192|"~     The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in~     the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis~     (AR/ARC) in children and adults.~      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,~     results in significant reduction in the average total combined rhinitis score (TCRS).~   "
103667|NCT01700179|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks~     of treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.~   "
103668|NCT01700166|"~     The specific aims of this study are:~        1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with~          perinatal arterial ischemic stroke (AIS).~        2. To determine if late functional outcome, physiologic response, and anatomic findings~          are changed following hUCB infusion in children with perinatal AIS.~   "
103669|NCT01700153|"~     Cerebral Palsy (CP) is a major cause of impairments in child population. This disease~     justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised~     by robotics.~      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot~     allows the patient to perform active, passive, or assisted exercises.~      This therapy is designed to promote motor development in children with CP. Its finality is~     to improve patients' quality of life and participation.~      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP~     but none RCT has been done.~      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in~     children with cerebral palsy by evaluating the 3 fields of the ICF (International~     Classification of Functioning, Disability and Health) and performing a prospective~     randomized controlled single blind trial. Therefore, all patients will benefit from a~     classical rehabilitation as a basis. Furthermore, patients of the control and experimental~     groups will receive a supplement of classical rehabilitation and robotic-assisted therapy,~     respectively.~   "
103670|NCT01700140|"~     The purpose of this study is to explore the dose response of SyB D-0701 for preventing~     nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in~     cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation)~     alone.~   "
103704|NCT01699698|"~     Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis~     to screen UICC stage II pancreatic ductal adenocarcinoma patients.~   "
103705|NCT01699685|"~     The study purpose is to evaluate the effect of QAB149~        -  NVA237 vs. QAB149 on static lung hyperinflation.~   "
104040|NCT01695265|"~     Using the FEELBREATHE®, a nasal ventilatory restriction device, during an exercise test in~     treadmill, produce physiological changes in patients with Chronic Obstructive Pulmonary~     Disease (COPD).~      These changes may improve strength and endurance of the inspiratory muscles and improve~     exercise tolerance in these patients.~   "
103671|NCT01700127|"~     This will be a randomized study with the primary objective of assessing the impact of~     withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.~      Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14~     weeks. The subjects will be randomized into one of the two study arms. In one of the group~     caregivers will be advised to breastfeed immediately prior to and after each dose of the~     vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30~     minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and~     Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The~     enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.~   "
103672|NCT01700114|"~     The purpose of this study is to collect data to describe the real-world use and safety and~     effectiveness of MelaFind® in a post-approval clinical setting.~   "
103673|NCT01700101|"~     We have added objectives 4-6 to our updated study:~      Study Objective 1: To determine whether the distribution of MelaFind scores is different for~     different patients with multiple nevi, and whether such distributions can be utilized to~     identify signature lesions for a given patient.~      Study Objective 2: To investigate whether distributions of quantitative ABCD parameters~     differ among patients and whether these qABCD parameters identify signature lesions.~      Study Objective 3: To determine the feasibility of defining and using relative thresholds to~     improve the specificity of MelaFind without sacrificing its high sensitivity.~      Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for~     different patient and lesion characteristics.~      Study Objective 5: To identify patient and lesion characteristics that result in the highest~     variability of MelaFind scores for a given lesion.~      Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual~     threshold for lesions to be considered for biopsy to rule out melanoma on patients with~     multiple nevi.~   "
103674|NCT01700088|"~     At our institute,during the first 2 hour postoperative, we used to give supplement oxygen~     via face mask in patient having lung resection surgery. After then if the patient is fine,~     we'll replace the face mask with nasal cannular untie the next morning. We hypothesized that~     oxygen mask can be replace by nasal cannular without any hypoxia.~   "
103675|NCT01700075|"~     Study the mechanisms of atherosclerosis based on a comparative study of physical and~     chemical properties of lipid tissues at various localization with subsequent development of~     concept of treatment and prevention.~   "
103676|NCT01700062|"~     aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or~     standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer~     undergoing surgery~   "
103677|NCT01700049|"~     The purpose of this study is to investigate the safety and effectiveness of oral vismodegib~     therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC).~     The term 'histologic subtype' refers to how the cells and tumor tissue looks under the~     microscope. Three different 'histologic subtypes' of basal cell skin cancer~     (infiltrative/morpheaform, nodular and superficial) will be examined in this study.~   "
103678|NCT01700036|"~     This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha~     1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor [Human]) for~     the treatment of steroid refractory GVHD.~      For bone marrow transplant patients, the most common, serious complication is Graft vs Host~     Disease (GVHD), which at its most severe is a life-threatening, complication and a~     significant cause of treatment related death, following stem cell transplantation. GVHD is a~     major obstacle to the overall success of transplant treatment, a strategy that would~     otherwise provide the possibility of a cure for patients with blood cancers or severe blood~     disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves~     the interaction of the recipient's (the host's) cells and tissues with the donor's immune~     system cells that see the host tissues as foreign, and attack the host's cells resulting in~     tissue and organ damage.~      The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to~     steroid therapy, the complication is nearly always fatal, either from organ damage or~     opportunistic infection as a consequence of high dose, steroid treatments.~      There is currently no known effective therapy for patients with acute graft vs host disease~     that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming~     majority of these patients may ultimately die from infection. The incidence of acute GvHD~     that requires intervention, is higher for unrelated donor transplants, the most common~     treatment option available, and therefore, these patients are at higher risk for treatment~     related complications from GVHD. Approximately 20,000 unrelated donor transplants are~     performed each year. The magnitude of this problem then is significant for patients who~     otherwise might be cured of their blood cancer or disease.~   "
103679|NCT01700023|"~     The purpose of the study is two-fold:~        1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute~          heart failure with leg-edema.~        2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure~          measurement in patients hospitalized for acute heart failure.~   "
103680|NCT01700010|"~     This study will involve subjects who have advanced urothelial cancer who are platinum~     refractory (platinum based chemotherapies that are not effective in treating the cancer),~     and who are over-expressing EGFR and/or HER2, or do not over-express EGFR and HER2. Genetic~     expression is a process that takes inherited information in genes (like DNA sequence), and~     from that information makes a specific functional product (sometimes called a gene product)~     such as RNA (ribonucleic acid) or protein. Normal tissue cells have a particular genetic~     expression, which changes when they turn into cancer. EGFR and HER2 are involved in the~     process by which normal cells are transformed into cancer cells.~      The main purpose of the study is to look at the proportion of subjects, who over-express~     EGFR and/or HER2, who do not progress (cancer gets worse) after 16 weeks of study treatment~     with daily lapatinib and weekly paclitaxel. The study will also look at the safety and~     effectiveness of this therapy in all subjects.~      Another part of this study will look at blood and tissue samples. Blood samples will be~     collected to see how many cells express EGFR and HER2 before study treatment and at the time~     the cancer gets worse. Tumor tissue will be analyzed to look at the expression of certain~     genes in advanced urothelial cancer. Some gene expression tests can reveal how cancer cells~     are different from normal cells and the results might lead to more accurate diagnosis and~     treatment.~   "
103706|NCT01699672|"~     The main aim of the current study is to investigate whether the addition of a~     standardized,group-based educational program to the information provided by health care~     personnel improves cancer patients' knowledge level about their disease, planned treatment~     and common side-effects of the treatment.~      Secondary aims are to investigate if the addition of the educational program increases the~     likelihood of completing treatment as planned, reduces level of anxiety, reduces the~     frequency of serious side effects, increases patient reported health related quality of~     life, and increases the degree of patient satisfaction with respect to how they have~     received the information before, during and after treatment.~   "
103681|NCT01699997|"~     Background: A large body of research has shown that Oxytocin (OXT) is an important prosocial~     peptide and there is also initial evidence that the central OXT system is altered in several~     mental disorders that are characterized by severe social disturbances and deficits, such as~     anxiety disorders with prominent social dysfunction (e.g., schizophrenia), mood disorders~     and borderline personality disorder. OXT may reduce psychotic symptoms and may diminish~     certain social cognition deficits that are not improved by current antipsychotic~     medications.~      Aims: The project has two main aims, listed below:~        1. To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with~          schizophrenia in association with second-generation antipsychotics (SGA);~        2. To use an Emotional Priming Paradigm task to assess pre- and post-treatment change in~          the patients general cognitive and emotional status.~      Study Design: Randomized, double-blind, placebo-controlled, cross over design. Materials and~     methods: Patients involved in the study will be recruited in six centres in the north of~     Italy. Each subject (aged 18-45, with a duration of the disorder no longer than 10 years)~     will be enrolled after a screening phase. 80 patients will be randomly assigned to either 40~     IU OXT once daily or vehicle placebo, in addition to their pre-study antipsychotic~     medication regimen: all reasonable attempts maintain the same SGA dosages throughout the~     study will be made. The study ratio is 1:1. The total study duration for each individual~     subject will be approximately 8 months, which includes an up to 7-day screening period, a~     baseline randomization visit, and a four month long cross-over treatment period. Subjects~     will be trained by researchers about the self-administration of intranasal OXT. A~     trustworthy caregiver will be trained as well. Each patient will receive every morning a SMS~     text message on his mobile phone as a reminder for OXT administration.~      Before starting the treatment, all patients will be assessed with standardized assessment~     instruments and will undergo an in depth neuropsychological assessment; additional~     evaluations, including safety evaluations, will be performed at 4 and 8 month follow-ups.~      The primary outcome measure will be the negative score in the Positive and Negative Syndrome~     Scale (PANSS) performed at 2,4,6 and 8 months since the start of the treatment.~   "
103682|NCT01699984|"~     This prospective observational cohort study aims at studying functional and clinical~     outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of~     God Order in Northern Italy during an index period of 4 months. Other areas assessed include~     variables that help or hinder the discharge of patients with sufficient residential autonomy~     and the predictive ability of clinicians compared with the evaluation of selective~     indicators of outcome (clinical and instrumental).~      Patients are followed from the first day of hospitalization until discharge or up to 3~     months and 1 day after the date of admission (long-term care patients).~      At admission a Patient Form including social, demographic and clinical informations and a~     series of standardized assessment tools is completed with the help of clinicians, nurses and~     caregivers (when available).~      For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms~     is performed and adverse events occurred during hospitalization are monitored, as well as~     the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at~     discharge (or after 3 months for long-term care patients) and at 6 months follow-up of~     with a standardized telephone interview to assess clinical and functional status and~     possible changes in the residential status of the patient.~   "
103683|NCT01699971|"~     The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain~     postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of~     life, recovery from surgery and frequency of recurrencies in the three groups~   "
103684|NCT01699958|"~     The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect~     of the healthy Living Study, a brief outpatient problem-solving intervention to promote~     healthy eating and activity habits in adolescents.~   "
103685|NCT01699945|"~     The goal of this study is to generate unique information to guide improvements on~     interventions to reduce maternal and newborn mortality as well as prevent stillbirths.~      The objective of this study is to determine the burden, timing, and causes of maternal~     deaths, stillbirths and neonatal deaths.~      This will be an observational study where data will be collected retrospectively in the~     context of the ongoing study in Haryana, India.~      Women of reproductive age living in the study area have already been enumerated for the~     parent studies. Active surveillance is being conducted for identifying pregnancies and~     deaths among women of reproductive age in the population through 3 monthly home visitations.~      Verbal autopsies will be conducted for all deaths of women in the reproductive age,~     including those who died in pregnancy, childbirth and up to 42-60 days after childbirth.~     Verbal autopsy interviews will also be conducted for all stillbirths.~   "
103686|NCT01699932|"~     Primary Objective:~      -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of~     HbA1c reduction, during 24-week treatment period in patients with inadequately controlled~     type 2 diabetes mellitus.~      Secondary Objective:~      To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:~        -  Percentage of patients reaching HbA1c <7%~        -  Percentage of patients reaching HbA1c <6.5%.~        -  Fasting Plasma Glucose (FPG)~        -  Safety and tolerability~   "
103687|NCT01699919|"~     The primary objectives of this study are to analyse the effect of perioperative systemic~     infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and~     perioperative levels of inflammatory mediators in patients undergoing elective open~     abdominal surgeries.~      The secondary parameters which will be observed during the study are the time to passage of~     flatus and stools postoperatively.~   "
103688|NCT01699906|"~     Breast cancer is one of the most frequently seen cancers in the United States. It occurs at~     all ages but is particularly common in post menopausal women. Obesity increases the risk of~     breast cancer and colon cancer among others, and when cancer develops increases the risk of~     spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are~     also seen with obesity. Animal experiments have shown the inflammation in fat tissue~     increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower~     estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of~     other cancers in the body. Weight reduction in obesity has been shown in epidemiology~     studies to lower the risk of colon cancer and in obese women to lower the risk of breast~     cancer. However, how that occurs and how much weight loss is necessary is not known. In~     mice, calorie restriction in obese animals has been shown to reduce inflammation in fat~     tissue and the breast. In other studies, calorie reduction has been shown to lower the~     development of cancer. In addition, we really do not know what starts the whole inflammation~     process. One good possibility is that immune factors that tend to reduce inflammation are~     less in obesity. We have shown this in the colon and this also has been suggested as~     occurring in fat stores.~   "
103689|NCT01699893|"~     The purpose of this study is to assess the determinants of immunologic variance within the~     general healthy population.~   "
103707|NCT01699659|"~     Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as~     protocols described in the Allergy literature.~   "
103690|NCT01699880|"~     Tracheal intubation of critically ill patients is associated in the intensive care unit~     (ICU) with significant complications and morbidity. Patient desaturation is one of the most~     common complications that may lead to cardiac arrest despite pre-intubation oxygenation.~     Preoxygenation can be improved by the use of non-invasive ventilation, but this technique~     can be cumbersome to implement in the context of urgent intubation and more importantly it~     does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a~     technique that has been shown to improve patient oxygenation in the context of acute~     hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the~     setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this~     study is to compare pre- and per-intubation (during intubation) oxygenation with either a~     conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high~     flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).~   "
103691|NCT01699867|"~     This multi-center, prospective, open label study analyzed specimens from fifty subjects at~     two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in~     accordance with the inclusion and exclusion criteria. The study period per subject was the~     time it took to assess the ex vivo breast tissue sample using the study device. Image review~     was conducted after surgery and compared to the margin status findings in the post-operative~     pathology report.~   "
103692|NCT01699854|"~     In the present study the investigators intend to investigate analgesic and sensory effects~     of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory~     abnormalities in the skin.~   "
103693|NCT01699841|"~     The purpose of this study is to understand how breast milk may protect infants from~     infection and promote favorable immunological, growth and development outcomes. By following~     mothers and their infants, we will evaluate the important interactions between infant immune~     responses and infectious disease events in relation to breast milk composition and feeding~     patterns. Our aim is to identify a set of predictive factors corresponding to healthy early~     infant growth and development in this setting in Northern Tanzania.~   "
103694|NCT01699828|"~     The objective of the present study is to use positron emission tomography brain imaging to~     investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin~     partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that~     clinically relevant doses of buspirone will occupy the D3 receptor.~   "
103695|NCT01699815|"~     The purpose of the study is to examine the effects of timing of administration of~     intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by~     postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present~     for a scheduled total hip replacement under general anesthesia will be randomized into one~     of two arms: 1) the pre-closure group will receive the first dose administered upon onset of~     skin closure, 2) the preemptive group will receive the first dose administered within 60~     minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24~     hours.~   "
103696|NCT01699802|"~     The purpose is to investigate how the adsorptive capacity of the active carbon filter to~     carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled~     anaesthetic agent.~      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of~     adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon~     dioxide.~   "
103697|NCT01699789|"~     CPIC is a community initiative and research study funded by the NIH. CPIC was developed and~     is being run by community and academic partners in Los Angeles underserved communities of~     color. CPIC compares two ways of supporting diverse health and social programs in~     under-resourced communities to improve their services to depressed clients. One approach is~     time-limited expert technical assistance coupled with culturally-competent community~     outreach to individual programs, on how to use quality improvement toolkits for depression~     that have already been proven to be effective or helpful in primary care settings, but~     adapted for this study for use in diverse community-based programs in underserved~     communities. The other approach brings different types of agencies and members in a~     community together in a 4 to 6-month planning process, to fit the same depression quality~     improvement programs to the needs and strengths of the community and to develop a network of~     programs serving the community to support clients with depression together. The study is~     designed to determine the added value of community engagement and planning over and above~     what might be offered through a community-oriented, disease management company. Both~     intervention models are based on the same quality improvement toolkits that support team~     leadership, care management, Cognitive Behavioral Therapy, medication management, and~     patient education and activation. Investigators hypothesized that the community engagement~     approach would increase agency and clinician participation in evidence-based trainings and~     improve client mental health-related quality of life. In addition, during the design phase,~     community participants prioritized adding as outcomes indicators of social determinants of~     mental health, including physical functioning, risk factors for homelessness and employment.~     Investigators hypothesized by activating community agencies that can address health and~     social services needs to engage depressed clients, these outcomes would also be improved~     more in the collaboration condition. Investigators also hypothesized that the collaboration~     approach would increase use of services.~   "
103698|NCT01699776|"~     It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in~     patients with heart failure, especially in the presence of atrial fibrillation (AF). It is~     the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical~     outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart~     failure was compared.~      Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with~     preserved left ventricular systolic function were treated with digoxin and ivabradine for 3~     months, according to a randomization cross-over design.~      Collected data Medical history, physical examination, laboratory (including proBNP and serum~     digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi,~     e/e1 ratio).~   "
103699|NCT01699763|"~     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose~     Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from~     other companies. All meter BG results were compared with plasma results obtained with a~     reference laboratory glucose method (YSI Glucose Analyzer).~   "
103700|NCT01699750|"~     The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and~     visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses~     when used in conjunction with two contact lens care systems.~   "
103701|NCT01699737|"~     The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to~     assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients~     either treated with metformin or treatment-naïve.~   "
103702|NCT01699724|"~     The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and~     without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition~     with water in Healthy Japanese Subjects~   "
103708|NCT01699646|"~     Hypothesis:~      STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia~     and reduce the number of newborns with metabolic acidosis.~      Primary endpoint:~      1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery~     < 7.05 and standard base excess <-10.~      Secondary endpoints:~        1. Number of intervention (VE and caesarean section) in the two groups~        2. Number of pH measurements in the two groups~        3. Number of neonates admitted to the neonatal department because of suspected asphyxia in~          the two groups~      The aim of fetal surveillance is to identify those fetuses at risk for developing damage in~     newborn to term or long term damage caused by lack of oxygen during birth process.~     Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is~     believed to be caused by lack of oxygen during birth. These can be avoided if the~     investigators intervene actively in the birth before damage occurs.~      CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine~     contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method~     of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in~     CTG interpretation may therefore lead to increase in the number of deliveries with vacuum~     suction and caesarean section. Interpretation of CTG can be improved by analyzing the~     acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis~     shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and~     requires repeated measurements if the abnormal heart rate pattern persists. This method is~     the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.~      The problem seems to be partially alleviated by using a newly developed method for fetal~     surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG~     (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes~     a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The~     technique is easy to use, since it only requires one electrode on the fetal scalp that is~     placed in the same way as in ordinary CTG registration.~   "
103709|NCT01699633|"~     Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for~     treatment of HIV in children younger than 3 years old who have tuberculosis (TB)~     coinfection. However, there is very limited data on the drug-drug interactions between~     rifampin and nevirapine in children of this age group. The purpose of this study is to~     determine the effect of rifampin-containing anti-TB treatment on the blood levels of~     nevirapine in young children with HIV and TB coinfection. Also, the study will find out~     whether checking the genetic makeup of a child could help to determine the appropriate dose~     of nevirapine in the setting of concomitant anti-TB treatment.~   "
103710|NCT01699620|"~     The study compares two different operative techniques for placement of the Cochlear Bi300~     implant to be used for bone anchored hearing aid. The operative techniques to be compared~     are~        -  Dermatome technique with soft tissue reduction~        -  Linear incision with minimal or no soft tissue reduction~      The hypothesis is that the operative techniques are comparable with regard to implant~     stability, soft tissue healing and loss of sensibility around the implant.~      To evaluate the evolution of implant stability during the early healing period after~     implantation, which is the most critical period for osseointegrated implants, in particular~     when early loading protocols are used.~      To compare soft tissue healing around Baha implants placed according to the recommended~     surgical technique with skin transplant and Baha implants without performing skin reduction.~      To compare the loss of sensibility of the skin around the Baha implant (some loss of~     cutaneous sensibility nerves in the transplant procedure) between the two surgical~     procedures.~      While the study focuses on the early healing period (3 months), long-term safety data will~     also be collected after 6 months and 1-year.~      The study will also evaluate the change in health status produced by the surgical~     intervention.~   "
103711|NCT01699607|"~     A research study designed to examine amphetamine-induced dopamine release using the PET~     imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute~     withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty~     healthy nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2~     [11C]PHNO PET scans. On the study day subjects will participate in two [11C]PHNO scans~     (ideally, the two PET scans will be carried out in the same day). Three hours before the~     second PET scan, amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will~     occur at 10-21 days of smoking abstinence.~   "
103712|NCT01699594|"~     Exposure to allergens changes the way the airway responds to some stimuli (methacholine).~     The investigators will look at whether or not exposure to allergens changes the way the~     airway responds to a different stimuli (mannitol) and compare that with the known stimuli~     (methacholine).~   "
103713|NCT01699581|"~     Nestle Impact has shown efficacy in multiple surgical trials in relation to improving~     hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will~     be taken orally three times a day beginning on the morning following stem cell transplant~     and will continue until the day of hospital discharge.~   "
103714|NCT01699568|"~     Objectives: To compare the stability of implant surface treated by dual acid etching~     (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after~     installation.~      Methods: it will be a clinical study with individuals with missing teeth requiring~     rehabilitation with dental implants in the maxilla and that fulfill the study inclusion~     criteria. The research sites will be randomized into two groups: the control group patient's~     sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant~     Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque~     Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability~     of the implants will be made over 16 weeks, through resonance frequency analysis with~     Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using~     descriptive statistics and comparative.~   "
103715|NCT01699555|"~     The purpose of this study is to assess the safety and tolerability of single ascending doses~     of GNbAC1 in healthy male subjects.~   "
103716|NCT01699542|"~     The purpose of this of this study is to compare the safety and effectiveness of temporary~     indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of~     refractory anastomotic esophageal strictures~   "
103717|NCT01699529|"~     This is a prospective, single-arm, non-randomized and open label feasibility study. The~     study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal~     denervation in patients with uncontrolled hypertension.~   "
103726|NCT01699412|"~     The purpose of this study is to perform a randomized, double-blind, clinical trial comparing~     the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of~     chronic graft-versus-host disease.~   "
103727|NCT01699399|"~     This prospective, randomized controlled trial compares traditional air insufflation with~     water immersion and water exchange in patients undergoing colonoscopy using on demand~     sedation. We test the hypothesis that compared with air insufflation the proportion of~     patients who require on demand sedation during colonoscopy will be significantly lowered by~     water immersion and water exchange, and water exchange will produce the greatest reduction~   "
103718|NCT01699516|"~     Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after~     allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still~     lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound~     sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal~     GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively~     evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011.~     Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group.~     Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal~     volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control~     group. All patients were evaluated with both standard transabdominal ultrasonography (US)~     and CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of~     symptoms. Standard US revealed non-specific bowel wall thickening, and simultaneous~     involvement of multiple intestinal segments in 9/14 patients. CEUS showed three distinct~     patterns of microcirculation changes that correlated with GVHD activity. These findings were~     not observed in the control group. Moreover, CEUS findings correlated with treatment~     response and predicted flare of intestinal symptoms. CEUS is a non-invasive, easily~     reproducible bed-side tool to detect and monitor intestinal GVHD.~   "
103719|NCT01699503|"~     The purpose of the study is to conduct a randomized clinical trial assessing the harms and~     benefits of screening for dementia, compared to no screening for dementia, among 4,000 older~     adults, cared for in typical, primary care practices.~   "
103720|NCT01699490|"~     The purpose of this study is to identify evidence-based guidelines for treating major~     depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients.~     To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of~     adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2)~     clarify the shared biological mechanisms between mood, immune and metabolism homeostasis~   "
103721|NCT01699477|"~     The aim of this study is to asses the efficacy and the clinical safety of the transcranial~     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec~     Ltd. for functional neurosurgery. The treatments to be conducted in this study are~     non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in~     specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this~     study will be used to evaluate the basic safety aspects of this new treatment technology and~     will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.~   "
103722|NCT01699464|"~     A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or~     timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.~   "
103723|NCT01699451|"~     This study is intended to obtain clinical information and establish a repository of DNA,~     RNA, peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and~     related neurodegenerative motor neuron diseases, people with a family history of these~     conditions, and healthy people with no family history of these disorders. The samples will~     be used in future research to learn about how these disorders affect people, what causes~     these conditions, and how the investigators can tell when someone has this kind of disease.~     Future research may also include the generation of stem cells from stored blood cell and~     skin cell samples. Participants will not be paid for taking part in this study.~   "
103724|NCT01699438|"~     Irritable bowel syndrome (IBS) is a condition characterised by abdominal pain or discomfort~     in combination with altered bowel function (stool frequency and/or stool consistency),~     currently defined by the Rome III criteria. The current IBS definition specifies that there~     are no structural or biochemical abnormalities to account for the symptoms but there is~     growing evidence that in at least a subset of IBS patients, a discrete immune activation~     might be a key pathogenetic factor. The condition is prone to develop after a~     gastroenteritis, post-infectious IBS, and increased numbers of lymphocytes, mast cells and~     pro-inflammatory cytokines like Interleukin (IL)-1β, IL-6, Tumor necrosis factor (TNF)-α and~     a general increase in mucosal cellularity have been reported. Despite this, the efficacy of~     anti-inflammatory agents has been poorly investigated.~      This will be a randomised, double blind, placebo-controlled, parallel-group, multi-centre~     study that aims to include a total of 200 subjects with irritable bowel syndrome (IBS). All~     subjects will be randomised to receive either 3x800 mg of mesalazine (Asacol®) or~     corresponding placebo once daily for a total treatment duration of 8 weeks. Males and~     females aged 18 to 70 years who already are diagnosed with IBS based on the Rome III~     diagnostic criteria and with a symptom intensity of at least moderate level; defined as an~     IBS Severity Scoring System (IBS-SSS) score of ≥175 at both Screening (Visit 1, Day -21±2)~     and Baseline (Visit 2, Day 0) will be eligible to enter the study.~      Primary aim:~      To assess the effect of mesalazine (Asacol®) treatment compared to placebo on global IBS~     symptoms: A treatment responder will be defined by answering the satisfactory relief of~     IBS-symptoms question yes at the end of at least 4 out of of 8 treatment weeks.~      Secondary aims:~      To assess mesalazine (Asacol®) treatment compared to placebo regarding:~        1. Levels of inflammatory mediators in the rectal mucosa (e.g. neutrophil mediators,~          eosinophilic mediators, mast cell activity mediators and cytokines) measured by a new~          diagnostic tool, the Mucosal Patch Technology (MPT) by means of Enzyme-Linked~          Immunosorbent Assays (ELISA)~        2. Effects on number of immune cells (count per high power field) and cytokine content~          (immunohistochemistry) in mucosal biopsies~        3. Calprotectin levels in faeces (mg/kg)~        4. Individual IBS symptom parameters derived from a symptom diary and also measured by~          IBS-SSS~   "
103725|NCT01699425|"~     The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure~     rates comparable to those obtained by retropubic suburethral tape, becoming the first line~     treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not~     exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In~     addition it is commonly performed under general or regional anesthesia1-3. The~     single-incision mini-slings (SIMS) were developed to reduce the risk of complications by~     avoiding the blind passage of the trocars through the obturator space. In addition, the use~     of SIMS could enable surgeons to perform the procedure truly under local anesthesia.~      Different devices for SIMS procedure are available. However, the evidence about their~     efficacy is controversial4-7. The main limitation of these devices could be the~     predetermined length of the mesh and the weakness on its fixation. The design of the SIMS~     Ajust® allows adjusting the length of the sling to each individual woman and provides a~     robust fixation into the obturator membrane. Recent prospective studies on the efficacy and~     safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines~     advise to use SIMS in the context of research studies10.~      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is~     non-inferior to that of a standard TOT, as well as to compare the comorbidity of both~     procedures. Owing to the new appearance and fast evolution of these procedures, randomized~     comparative studies with SIMS are required in order to determine its place in the treatment~     of SUI.~   "
103728|NCT01699386|"~     Effects on weight will be monitored in healthy infant subjects consuming assigned infant~     formulas.~   "
103731|NCT01699347|"~     Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head~     and neck region.~      The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood~     tests.~      The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up~     will be of short term - till 30 days post injection and long term - follow-up wil be till 2~     years.~   "
103732|NCT01699334|"~     The purpose of this study is to examine the effect of an educational video on intensity of~     neck pain, disability, illness perceptions and work ability following acute whiplash trauma~     caused by motor vehicle accidents.~   "
103733|NCT01699321|"~     Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop~     research study will test the effectiveness of a program aimed at increasing physical~     activity among African American men. Approximately 14 barbershops and 560 shop customers~     within Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this~     research study. If FITShop is effective, we will share our results throughout North Carolina~     and nationally.~   "
103734|NCT01699308|"~     The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter~     structural integrity (DTI) of persons with mild to severe TBI with and without Growth~     Hormone deficiency during cognitive tasks; and to examine changes in cognitive and motor~     performance, EEG/fMRI and white matter integrity associated with growth hormone treatment~     for twelve months using an open-label design in persons with GH deficiency/insufficiency~     following mild to severe TBI. To meet this aim, we are in the process of screening 40~     persons with mild to severe TBI, ages 18-55, who are at least six months post injury. After~     screening, 10 persons with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH~     injections titrated to bring their GH levels into the normal range over the course of twelve~     months. Treatment will be initiated using rhGH (Genotropin). Subjects with TBI and GHD will~     be assessed at baseline, 6 months, and 12 months with EEG, fMRI and DTI, and~     neuropsychological measures. 5 persons with TBI who do not have GHD will be assessed at~     baseline and at 12 months with EEG, fMRI and DTI, and neuropsychological measures.~   "
103735|NCT01699295|"~     There is currently considerable interest in both improving academic achievement (No Child~     Left Behind) and reducing the rates of obesity and its associated negative health~     consequences in elementary school students. Increased physical activity (PA) offers a~     potential intervention to address both issues. Evidence is available which suggests an~     association of PA with both academic achievement and obesity, and an association between~     obesity and academic achievement.~      To provide increased PA while maintaining academic instruction time, we developed a program~     we call Physical Activity Across the Curriculum (PAAC) in which regular classroom teachers~     were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)~     for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between~     students in elementary schools that participate in academic lessons taught through MVPA~     (PAAC) to students that do not (CON).~   "
103736|NCT01699282|"~     To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital~     of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed~     since January 2009, a therapeutic education to use oral anticoagulants, in collaboration~     with the functional rehabilitation center Durtol. All patients under VKA, are formed by~     nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the~     therapeutic impact of two methods of comprehensive education, one conventional and performed~     by nurses service, less elaborate, relying solely on the book Information from The National~     Security Agency of Medicines and Health Products, the other based on more detailed documents~     created by a multidisciplinary group. Various studies show that the effect of therapeutic~     education is observed only during the first six months and then disappears.~      This study is the first French study evaluating the impact of a comprehensive education to~     oral anticoagulation according to the latest recommendations of the National Security Agency~     of Medicines and Health Products and the French National Health Authority.~   "
103737|NCT01699269|"~     This study will examine the use of a variation of standard magnetic resonance imaging (MRI)~     called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter~     infiltration of high grade brain tumors. Organized architecture is destroyed once brain~     tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic~     (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary~     outcome is to find if a correlation exists between GA (generalized anisotropy) and the~     infiltration percentage of stereotactic peritumoral biopsies.~   "
103738|NCT01699256|"~     The aim of this study is to evaluate whether an enhanced strategy of implementation of the~     new guideline will lower the number of patients getting referred to secondary care spine~     centres compared to a normal implementation strategy.~   "
103739|NCT01699243|"~     Machine learning techniques and algorithms originally developed for use in the field of~     robotics can be applied to continuous, noninvasive physiological waveform data to discover~     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict~     cardiovascular collapse well ahead of any clinically significant changes in standard vital~     signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss~     volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same~     methods can be used to predict functional hypovolemia during regional anesthesia for labor~     or fetal intervention.~   "
103740|NCT01699230|"~     To show the existence of a atrial cardiomyocytes membranes modification in omega-3~     supplemented patients with coronary atherosclerosis.~   "
103741|NCT01699217|"~     The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML~     patients treated frontline with NIL. Patients will be followed for 5 years. This study will~     help the definition of guidelines for the treatment of CML patients in early CP.~   "
103742|NCT01699204|"~     This experiment is designed to test the hypothesis that oxidative stress is responsible for~     changes in airway responsiveness in humans exposed to diesel exhaust.~   "
103770|NCT01698827|"~     Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available~     in the market, however durability is variable. In a prospective randomized study, five~     commercial devices available in the market will be tested in 20 consecutive patients each.~     Tube performance will be observed during 6 months and durability will be assessed by~     Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design~     and material will influence outcome.~   "
103743|NCT01699191|"~     Probiotics play an important role in preventing overgrowth of potentially pathogenic~     bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of~     probiotics have been previously studied in adult patients with IBS. Clinical studies show~     that patients meeting the criteria for diagnosis for IBS have greater probability for being~     affected by celiac desease if compared to controls without IBS. Since one of the causes~     attributed to the onset of IBS is the modified flora gut, it is interesting to determine the~     beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease~     patients. The goal of the present study is to determine whether oral administration of a~     probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei,~     Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and~     Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would~     improve symptoms of adult celiac patients with IBS.~   "
103744|NCT01699178|"~     The purpose of this one year extension (follow-up) study is to gather additional safety data~     in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase~     III study CLAR-09007.~   "
103745|NCT01699165|"~     The purpose of this study is to assess the effect of reducing exposure to allergens in~     patients with hay fever by means of a nasal filter.~   "
103746|NCT01699152|"~     This is a multi-center, open-label, dose escalation study.~   "
103747|NCT01699139|"~     Supine positioning was reported to increase upper airway collapsibility, apnea frequency and~     duration. Positional therapy, designed to minimize supine sleep, was reported to be~     beneficial in the general sleep apnea population. As supine sleep is very common in stroke~     patients, positional therapy might also have therapeutic effects. Given differences between~     stroke patients with sleep apnea and the general sleep apnea patient, such as rolling~     ability, body mass index and daytime sleepiness, positional therapy results in the general~     population may not be applicable to the stroke patient.~      The effects of positional therapy in ischemic stroke patients with OSA have not been~     well-investigated. We therefore performed a pilot randomized, controlled, cross-over study~     to test the following hypotheses: (1) positional therapy reduces the amount of nocturnal~     supine positioning in patients with subacute ischemic stroke, and (2) severity of sleep~     apnea improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The~     tolerability of positional therapy over a 3-month period in patients with ischemic stroke~     was also evaluated.~   "
103748|NCT01699126|"~     study Hypothesis: We hypothesize that CPAP could effectively improve the endothelial~     dysfunction by anti-inflammatory effect in patients of OSA,and compare to the effect of~     statin.~   "
103749|NCT01699113|"~     The primary objectives are to find out in healthy subjects if:~        -  YF476 prevents the ECL-cell hyperplasia induced by repeated doses of rabeprazole - a~          proton pump inhibitor;~        -  YF476 also prevents rebound hyperacidity after stopping rabeprazole; and~        -  YF476 by itself causes neither ECL-cell hyperplasia after repeated doses nor rebound~          hyperacidity after stopping YF476.~      The secondary objectives are to:~        -  assess the safety and tolerability of YF476, alone and in combination with rabeprazole;~        -  compare the effects of YF476, alone and in combination with rabeprazole, on serum~          gastrin and plasma CgA and SST;~        -  assess if there is a pharmacokinetic interaction between YF476 and rabeprazole;~        -  assess the pharmacokinetics of repeat doses of YF476 by itself; and~        -  study the metabolism of YF476.~   "
103750|NCT01699100|"~     The purpose of this study was to determine if insoles with removable pegs could effectively~     reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for~     guidance of peg removal.~   "
103751|NCT01699074|"~     The study is a Phase-I like double blind randomized placebo controlled crossover design~     trial. The objective is to assess the dose response relationship on glycemic and vascular~     effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in~     individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2~     Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:~     as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will~     be recruited for the study.~   "
103752|NCT01699061|"~     The purpose of this study is to determine the effects of tivantinib on the QTc interval in~     patients with solid tumors~   "
103753|NCT01699048|"~     Minimally invasive revascularization of the left anterior descending artery followed by~     stent implantation versus percutaneous coronary intervention or coronary artery bypass in~     patients with multi-vessel coronary disease~   "
103754|NCT01699035|"~     Survey of survivor perspective on critical elements that either facilitate or inhibit return~     to work after a stroke. Critical elements are queried in areas of finances, stroke~     impairments, interpersonal support, therapeutic support, organization influences, work or~     job specific issues and psychological issues.~   "
103755|NCT01699022|"~     Cyclofem® is a monthly injectable contraceptive containing 25 mg of MPA and 5 mg of~     estradiol cypionate (E2C), a long acting ester of estradiol. The current study will assess~     the steady-state pharmacokinetics and pharmacodynamics of MPA and E2 after administration of~     Cyclofem® and will provide critical information to determine similar bioavailability of~     Cyclofem to Lunelle in women residing in the USA.~   "
103756|NCT01699009|"~     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,~     vegan diet improves pain more effectively than a control supplement or a placebo. The~     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in~     migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,~     plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using~     the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck~     Depression Inventory II (BDI-II).~   "
103757|NCT01698996|"~     Adult patients presenting to the emergency department with superficial cutaneous abscesses~     will be randomized after incision and drainage to standard care with wound packing or no~     packing to determine if there is a difference in the proportion of complications between the~     two groups.~   "
103771|NCT01698814|"~     The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic~     solution in subjects 2 years of age and older with asymptomatic eyes when administered once~     daily in both eyes for up to 6 weeks.~   "
103772|NCT01698801|"~     To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in~     Japanese subjects with previously untreated multiple myeloma.~   "
103758|NCT01698983|"~     Gluococorticoids are commonly prescribed to treat a number of diseases including the~     majority of inflammatory diseases. Despite considerable inter-personal variability in~     responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the~     risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to~     determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of~     this study is to perform a whole blood ex vivo stimulation assay to interrogate known~     glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid~     sensitivity and compare the results between severe and non-severe asthmatics.~   "
103759|NCT01698970|"~     A double-blind, multicentre, stratified by centre, randomised, parallel study with two~     groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of~     probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic~     lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56)~     or control product (N=56) during one year.~   "
103760|NCT01698957|"~     The purpose of this study is to detect if adding resistance to maternal blood flow from the~     arm will help increase the blood flow through the uterine arteries to the placenta and the~     baby.~   "
103761|NCT01698944|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     growth hormone on left ventricle morphology and function (systolic and diastolic).~   "
103762|NCT01698931|"~     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of~     repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2~     diabetes.~   "
103763|NCT01698918|"~     The purpose of this study is to find out if combining everolimus with letrozole is safe and~     has beneficial effects in postmenopausal women who have estrogen positive HER2 negative~     locally advanced or metastatic breast cancer. Additionally, this study aims to find out if~     everolimus plus exemestane is safe and has beneficial effects in women with estrogen~     positive locally advanced or metastatic breast cancer after treatment with everolimus plus~     letrozole. This study will also aim to find out if a mouth rinse can help reduce the~     severity of oral stomatitis, a common side effect of everolimus. This part of the study will~     be conducted only in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution~     is commercially available.~   "
103764|NCT01698905|"~     A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in~     chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib~     (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for~     at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at~     least 3 years and have very small amount of leukemia cells remaining after the nilotinib~     (Tasigna) treatment will qualify for the study.~   "
103765|NCT01698892|"~     Bronchoscopy is a technique which currently allows the investigation of many respiratory~     diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic~     procedures.~      Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication~     before endoscopy, but practices concerning the use of sedation further to the completion of~     the endoscopy are very heterogeneous.~      We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to~     I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy~   "
103766|NCT01698879|"~     Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with~     altered ripening capacity. Due to excessive proliferation, the blasts displace normal~     hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate~     extramedullary tissues.~      Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all~     patients and 15% lower when considering only patients over 65 years. Modifications to the~     standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of~     ara-C or adding a third drug.~      Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a~     cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to~     CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ®~     selectively transports the cytotoxic agent calicheamicin into leukemic cells and~     hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the~     pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of~     the antibody anti-CD33 and its internalization by the cell, after which binds to and damages~     the DNA.~      Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse,~     for patients older than 60 years non-candidates for other intensive treatment modalities.~      Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the~     conventional therapy, it is logical to conduct a phase II trial exploring the role of~     Mylotarg ® in the early stages of treatment of AML.~      Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined~     with induction chemotherapy. The aim was to improve the CR rate reached with the latter and~     reduce relapse after achieving greater leukemic cytoreduction.~      Recent data from the HOVON group support that the administration of G-CSF before and during~     induction chemotherapy decreases the incidence of relapse in patients with AML, particularly~     those considered to have intermediate risk.~      Everything mentioned above justifies to investigate the combination of GO combined with~     chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of~     sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is~     effective and presents an acceptable toxicity it should be investigated.~   "
103767|NCT01698866|"~     The purpose of this study is to assess the seroconversion rate and the cellular immune~     response after vaccination against hepatitis B virus in patients with lymphoproliferative~     syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of~     treatment criteria.~   "
103768|NCT01698853|"~     Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally~     thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is~     organ hypoperfusion.~      Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde~     perfusion. However,whether the arterial oxygenation status from different parts of the body~     are the same in the condition of retrograde perfusion have not been studied.~      The present study is aimed to determine if there is difference in the arterial oxygenation~     between peripheral arterial and aortic root during the period of retrograde perfusion.In~     addition, the impact of artificial ventilation on the difference of arterial oxygenation~     will also be investigated.~   "
103769|NCT01698840|"~     Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation~     at birth. However, few data are available related to follow-up of infants receiving these~     formulas who were 28-34 weeks gestation at birth.~      Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead~     to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less~     than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).~   "
103838|NCT01697943|"~     The purpose of this study is to find out more about differences of the quality of life in~     patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y~     reconstruction. To find a better reconstruction for patients who received total gastrectomy.~   "
103773|NCT01698788|"~     This study is undertaken to determine effect of sustained release dexamethasone~     implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with~     diabetic macular edema~      Diabetic macular edema constitute important cause of visual impairment in patients with~     diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .~     Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,~     Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections~     macular edema persists as a consequence overlying taut posterior hyaloid membrane which~     needs to be removed by vitrectomy. Visual improvement after vitrectomy is related to the~     duration of edema, as well as the extent of intraretinal lipid and vascular~     nonperfusion.Even after surgery some patients might need repeat intravitreal bevacizumab or~     triamcinolone injections to take care of residual macular edema.Intravitreal Triamcinolone~     Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness~     and improve the visual acuity. However, recurrence of macular edema in patients who receive~     intravitreal TA is a major concern because of its short half life . In search for the ideal~     corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System~     (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed~     which has generated new interest in this molecule. It is a sustained release intravitreal~     implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug~     Administration) for treatment of macular edema in retinal vein occlusions. The present study~     introduces a novel concept of using intraoperative Ozurdex ® implant during taut posterior~     hyaloid removal and its effect in improving the surgical outcome~   "
103774|NCT01698775|"~     The purpose of this study is to evaluate the efficacy and safety of MK-3102 in participants~     with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end~     stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of~     the study is that MK-3102 compared to placebo produces greater reduction in glycosylated~     hemoglobin (A1C) after 24 weeks.~   "
103775|NCT01698762|"~     The goal of this research study is to compare a booklet and a DVD for patients with knee~     osteoarthritis, osteoporosis, or rheumatoid arthritis.~   "
103776|NCT01698749|"~     This study is undertaken to determine the effect of intravitreal long acting dexamethasone~     implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is~     important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser~     photocoagulation is the standard of care in its management. Several adjuncts including~     intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal~     anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.~     Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to~     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular~     edema in patients who receive intravitreal TA is a major concern as the patients need~     multiple repeat injections because of its short half life. A more potent steroid,~     dexamethasone has also been tried as an alternative to TA for macular edema; however, its~     short half life of only 3 hours prevents its clinical application. In search for the ideal~     corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System~     (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.~     Promising results have been shown in certain patients with retinal vein occlusions, uveitis~     receiving this intravitreal drug delivery system with improvement in visual acuity. The~     present study introduces a novel concept of using Ozurdex ® implant in patients with~     diabetic macular edema.~   "
103777|NCT01698736|"~     -  Recipient desensitization protocols were shown to enable successful living donor kidney~          transplantation across major ABO blood group barriers. For extracorporeal depletion of~          circulating ABO antibodies plasmapheresis or ABO blood group specific immunoadsorption~          (IA) are most commonly used.~        -  The efficiency of semiselective non-antigen specific IA in ABO-incompatible~          transplantation is currently not well established. One potential drawback of~          semiselective adsorbers could be an incomplete elimination of IgM.~        -  This randomized controlled crossover trial was designed to clarify whether membrane~          filtration, as an adjunct to semiselective IA, can substantially enhance elimination of~          IgM.~   "
103778|NCT01698723|"~     The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by~     an acute and rapid deterioration of liver function in a patient with previously~     well-compensated liver disease owing to the effects of a precipitating event. In this~     condition two insults act simultaneously, one being the preexisting liver injury (chronic~     liver disease) and the other acute injury which is responsible for the acute decompensation.~     HEV being a major factor responsible for this clinical entity and has a very high mortality~     rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can~     be an important drug in the treatment of these patients. Therefore the present study is~     designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.~   "
103779|NCT01698710|"~     This research study is a pilot study. In this pilot study we are testing the safety of a~     procedure. Investigational means that the Albumin bound paclitaxel (Abraxane) is still~     being studied and that research doctors are trying to find out more about it. It also means~     that the FDA has not approved Abraxane injection for your type of medical condition.~     Treatment of pancreatic cysts often requires follow-up imaging studies and surgical~     resection of the cysts. As part of standard medical care, you will be undergoing a~     diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to~     evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will~     undergo the injection of the drug into the cyst cavity if your cyst is thought to be~     cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.~   "
103780|NCT01698697|"~     This trial is conducted in Africa. The aim of this trial is to determine if a new~     formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a~     marketed insulin aspart formulation (U100).~   "
103781|NCT01698684|"~     The objectives of this study are to examine the therapeutic effects of two doses of avanafil~     after dosing in men with erectile dysfunction~   "
103782|NCT01698671|"~     The purpose of the study is to assess the performance and safety of the InterGard Synergy~     vascular graft.~   "
103783|NCT01698658|"~     This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with~     breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may~     help find and diagnose breast cancer.~   "
103784|NCT01698645|"~     National multicenter, prospective, observational study in cancer patients with chronic~     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic~     condition by a specialist in the treatment of cancer pain conditions.~      • Study objectives include assessment of early treatment satisfaction.~   "
119328|NCT01493960|"~     The purpose of this study is to determine if Kappaproct is effective in the treatment of~     chronic active ulcerative colitis patients not responding to available therapy.~   "
103785|NCT01698632|"~     The purpose of this study is to learn more about the appearance and behavior of~     benign-looking adnexal masses.~        -  Benign-looking means that when viewed here by ultrasound it has the appearance of~          looking not harmful or not malignant.~        -  Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the~          uterus (or where the uterus used to be if you previously had a hysterectomy). The~          adnexa includes, but is not limited to, the ovaries and the fallopian tubes.~        -  Masses refers to a variety of structures, including but not limited to:~             -  ovarian cysts that are fluid filled sacs within or attached to an ovary~             -  ovarian tumors that can be solid tissue or a combination of cysts and solid tissue~             -  hydrosalpinges that are fluid collections in the fallopian tube~      Many women have what appear to be benign adnexal masses. Many times, removal of the masses~     with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these~     masses could be cancer. There is not much information available for doctors to know how and~     when to follow these masses, or which ones will become cancer.~      This study will combine information from centers all around the world regarding the behavior~     of all types of benign adnexal masses. The aim of this study is to develop decision tools~     for doctors to know the best way to treat these masses in order to improve the detection of~     ovarian cancer while at the same time reduce the number of unnecessary operations.~   "
103786|NCT01698619|"~     We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac~     Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration,~     Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount~     Aconcagua.~   "
103787|NCT01698606|"~     In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim~     of phase 2 of the project is to investigate whether a community-based, 12-month intervention~     for overweight and obese preschool children 2-6 years of age and their families will be~     effective in reducing the participants' degree of overweight (BMI z-score) and in improving~     quality of life.~      In the final phase (phase 3), participating children will be randomized to either receiving~     a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6~     months later (control or wait list arm), in order to generate more robust effectiveness~     data. Participants will receive an additional free 6-month YMCA membership while~     participating in the study.~   "
103788|NCT01698593|"~     No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without~     epinephrine, but no one knows how the epinephrine affects the duration of the block. We also~     don't know how long the pain part of the block lasts, which is what counts.~      The goal of the study is to determine the duration of action of bupivacaine digital nerve~     blocks (with and without epinephrine) on finger temperature and the sensory modalities of~     pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be~     injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12~     hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain,~     the Semmes Weinstein monofilament test to measure light touch and pressure and a body~     surface thermometer to measure finger temperature. The time for the finger to return to~     normal sensation and temperature will be measured.~   "
103789|NCT01698580|"~     This study is a clinical trial designed to evaluate the effectiveness of a multifactorial~     falls prevention program in reducing the rate of falls.~      A multifactorial falls prevention program consisting of an individualized medical management~     of the modifiable risk factors, a progressive on-site body balance exercise plus a~     home-based exercise program, an educational/behavioral intervention and a fall prevention~     booklet will reduce the number of falls and fall rates when compared with usual care.~   "
103790|NCT01698567|"~     The purpose of this study is to discern whether supplementation of Antithrombin III will~     decrease coagulation and inflammation associated with cardiopulmonary bypass in infants~     undergoing cardiac surgery.~   "
103791|NCT01698554|"~     This study will evaluate the safety and efficacy of bimatoprost solution formulation A~     compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash~     hypotrichosis (inadequate eyelashes).~   "
103792|NCT01698541|"~     Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as~     comparator, in elderly (>60 yr) renal transplant recipients~   "
103793|NCT01698528|"~     The purpose of this study is to determine if using a diabetes management technology system,~     including a tablet computer, to track diabetes care and communicate with a clinician coach~     (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and~     safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management~     technology system with a clinician coach helps more individuals starting basal insulin~     achieve better glycemic control with less hypoglycemia compared with standard clinical~     practice at Joslin Diabetes Center.~   "
103794|NCT01698515|"~     The objective of this study is to evaluate the effect of Tumor Necrosis Factor (TNF)~     inhibition on oral parameters in patients with RA and to examine changes in levels of~     proinflammatory cytokines in serum, gingival crevicular fluid (GCF), and saliva at an early~     time point (6-8 wk) and a later time point (14-16 wk) after the initiation of therapy in~     relation to concomitant assessment of Rheumatoid arthritis (RA) and oral clinical variables.~      The purposes of the study are to:~        1. Determine if oral periodontal parameters are affected by TNF inhibition;~        2. Examine relationships between periodontal variables and RA variables with TNF~          inhibition;~        3. Determine if there may be potential early response markers of clinical RA response seen~          using ultrasensitive analysis of oral or serum cytokines.~   "
103839|NCT01697930|"~     This is a Phase I study. This study is the first time that a new experimental drug called~     18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed~     to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its~     injected. PET scanners are one of the kinds of scanners you normally find in a hospital~     radiology department. The researchers have found that tumors in animals absorb F-Glutamine.~     The researchers believe that scans with F-Glutamine might be able to find tumors in~     patients.~      This first in-human study is being done to see how long F-Glutamine lasts in the blood, when~     it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in~     the body. If the results of this trial are good, then the study doctors plan to use~     F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors~     compared to the standard types of scans that doctors use.~   "
103795|NCT01698502|"~     It is well known that continuous physical exercise leads to a number of changes in the body.~     Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases.~     Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity~     in primarily in muscle, but also in the liver increase.~      Also endocrine glands adapts according to the level of physical activity. It is known that~     in healthy, younger people the insulin secretion from the pancreas after administration of~     sugar consumed orally or given directly into a vein, is significantly lower in trained~     individuals compared with untrained. This change does, however, not only apply to glucose,~     as also stimulation by the amino acid arginine, shows the same pattern.~      It seems plausible that the endocrine glands/cells adapts to the level of physical training,~     but this has not yet been investigated.~      The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is~     called incretin hormones. They stimulate the glucose dependant insulin secretion in the~     pancreas and affect hunger/satiety. Whether the incretin production and thus their~     concentration in the blood is regulated by physical training is unknown.~      Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin~     sensitivity. As a consequence their (type 2 diabetics, at least early in their disease~     course) meal stimulated insulin release is greater than in healthy, normal weight~     individuals. This in spite of the fact that the incretin effect is reduced in obese people~     and patients with type 2 diabetes compared to healthy, normal weight.~      Whether physical training affects both the secretion of incretins and the incretin effect~     has not yet been studied.~      The purpose of this study is to investigate whether incretin hormones in physical~     well-trained young men have a changed effect on insulin secretion from the pancreas compared~     to untrained young men. A difference may indicate that the body's endocrine glands adapts to~     training mode.~      The investigators hypothesis is that incretin hormones have a decreased effect on the~     glucose dependant insulin release in physically trained persons and thus results in a lower~     insulin release at any given plasma glucose level.~   "
103796|NCT01698489|"~     Closer examination of granular lipid data in a large population offers numerous~     opportunities to generate new knowledge, ranging from studies examining concordance between~     commonly used lipid parameters to phenotypic characterization of rare or extreme disorders~     of lipid metabolism, opening possibilities to better personalize future treatment of~     abnormal blood lipids.~      STUDY POPULATION:~      The Very Large Database of Lipids (VLDL) includes adults and children who were clinically~     referred for a Vertical Auto Profile (VAP).~      LIPID MEASUREMENTS:~      The VAP test (Atherotech, Birmingham, Alabama, USA) directly measures cholesterol~     concentrations of low density lipoprotein, very low density lipoprotein, intermediate~     density lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a).~     Triglycerides in the database are directly measured using the Abbott ARCHITECT C‐8000 system~     (Abbott Park, Illinois, USA). Lipid distributions in the database closely match those from~     the population-representative National Health and Nutrition Examination Survey (NHANES)~     2007-2008.~      STUDY PROCEDURES:~      This database was investigator-initiated. Only de-identified data reach the investigational~     site. The first data harvest was in 2011, and encompassed 1,350,908 samples. The second~     harvest is underway; thus far, an updated database suited to assess seasonal variation has~     been established with 2,859,333 samples. The master database is housed at The Johns Hopkins~     Hospital in Baltimore, Maryland, and maintained by Drs. Jones and Martin. Only electronic~     data, and not biospecimens, are sent to Hopkins. The academic investigators have~     unrestricted access to study data, take responsibility for the accuracy of analyses, and~     have authority over manuscript preparation and submission.~      VARIABLES:~      The variables currently in the VLDL database are testing date, age, sex, low density~     lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density~     lipoprotein, their subfractions, lipoprotein(a), and LDL pattern. From these primary~     variables, many additional variables were derived for inclusion in the master database~     (e.g., non-HDL-C, Friedewald LDL-C, TC/HDL-C, etc.). Other analytes measured by validated~     assays in subsets of the VLDL database include apoB, apoA1, hsCRP, homocysteine, uric acid,~     insulin, hemoglobin A1c, 25-hydroxy vitamin D, cystatin C, Lp-PLA2, TSH, free T3 and T4,~     pro-BNP, direct bilirubin, CPK, creatinine and other components of the comprehensive~     metabolic panel, magnesium, and phosphate.~      DATABASE ORGANIZATION:~      In the current database, each record represents a unique patient. The 1st available VAP test~     for each patient is included. To meet the needs of a variety of research questions, we are~     prospectively planning to organize harvest 2 data into 3-year interval datasets (i.e., VLDL~     2006-2008, 2009-2011, VLDL 2012-2014, etc), a summation dataset (first VAP test for each~     patient), serial lab dataset (patients who have had repeated testing), and ancillary~     datasets (subsets of patients with coexisting data on other measures such as~     apolipoproteins, vitamin D, hs-CRP, TSH/T4, etc).~      INDIVIDUAL STUDIES:~      Individual VLDL studies will be based on a priori hypotheses or aims with statistical~     analysis plans (SAPs) peer-reviewed prior to execution. In the expandable Detailed~     Description section below, the VLDL investigators will periodically register individual~     studies and update their status on clinicaltrials.gov.~   "
103797|NCT01698476|"~     The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate~     together with standard anti-tuberculosis treatment to significantly improve clinical~     recovery among patients with untreated, active pulmonary tuberculosis.~   "
103798|NCT01698463|"~     Falls and fractures are a leading cause of death and disability in the older adult~     population. The consequences of falls and fractures contribute substantially to health care~     costs and can have a significant negative impact on the quality of life of the individual.~     Exercise has been studied as an option to reduce fracture risk and prevent falls though~     improving balance and muscle strength. The prevention of falls is important, as a history of~     falls is strongly predictive of suffering another. Those who are at a high risk of fracture~     or falling require a patient specific assessment and individualized exercise prescription~     that is tailored to their needs. This kind of program may not be typically available within~     the community and at a low cost. These individuals may experience difficulty when trying to~     engage in exercise due to barriers such as a lack of transportation, and a lack of~     knowledge. As the first point of contact with the health care system for many family doctors~     are in the ideal position to deliver exercise advice to their patients. However, a lack of~     time and specialized skills in prescribing exercise make this difficult for many of them. As~     a result, family health teams who provide interdisciplinary patient centered care are~     becoming popular. In this model the care is shared and provided by the most appropriate team~     member (e.g. doctor, nurse, exercise specialist). Additionally, many exercise interventions~     do not include a behavior change aspect, which may be an important component when trying to~     get individuals to engage in a new health behavior like exercise. Therefore the purpose of~     this project is to assess the feasibility of implementing a tailored exercise program to~     those at high risk of falls or fractures over the age of 65 in a primary care setting using~     an interdisciplinary model of care that is based on a health behaviour change model.~   "
103799|NCT01698450|"~     The aim of this study is to asses the efficacy and the clinical safety of the transcranial~     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec~     Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to~     be conducted in this study are non-invasive, i.e. without opening the skull, and will create~     microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The~     data obtained in this study will be used to evaluate the basic safety aspects of this new~     treatment technology and will serve as a basis for the clinical introduction of MR-guided~     ultrasound neurosurgery.~   "
103800|NCT01698437|"~     Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal~     ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the~     target organ. The physician then identifies a target volume in the MR images and delineates~     the treatment contours on the images. Therapy planning software calculates the parameters~     required to effectively treat the defined target volume. During the treatment an ultrasound~     transducer generates and focuses ultrasound energy to a focal point, called a sonication.~     The sonication raises the tissue temperature within a well-defined region to a degree, which~     causes thermal coagulation. MR images acquired during sonication provide a quantitative,~     real-time temperature map of the target area to confirm the location of the sonication and~     the size of the coagulated region. The sonication process is repeated at multiple adjacent~     points to cover the entire prescribed treatment volume.~   "
103801|NCT01698424|"~     Our goal is to develop and test a new imaging technique to help scientists study sarcopenia,~     the process by which muscle becomes weaker with age. This imaging technique uses Positron~     Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle~     to synthesize new protein. This ability to build new muscle protein is known as the Protein~     Synthesis Rate, and is thought to decline as people age and to contribute to muscle~     weakening. We are researching this technique in order to develop a tool to help scientists~     and physicians better understand how muscle ages and how it changes based on some stimulus,~     such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our~     research is successful, it will provide a new method for scientists and physicians to test~     the effectiveness of new drugs and other treatments for muscle weakness. The study will look~     for healthy woman between the ages of 65 and 80.~   "
103802|NCT01698411|"~     Several epidemiological studies in large cohorts suggest a strong association between sleep~     duration, complaint of insomnia and risk of hypertension.These findings suggest an important~     role of sleep quality in development of hypertension. Principal limitations of these studies~     are the cross-sectional study design, self-report sleep duration and poor measurement of~     blood pressure. The investigators propose to study an insomniac population with complete~     evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement~     of hypertension.~   "
103803|NCT01698398|"~     The purpose of the study is to examine the relationship between working capacity (peak~     oxygen consumption) and pump speed of continuous flow left ventricular assist devices~     (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak~     oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.~      The study population will consist of severe heart failure patients with CF-LVADs treated at~     The Heart Centre of Copenhagen University Hospital Rigshospitalet.~   "
103804|NCT01698385|"~     OVERALL OBJECTIVES:~        1. To assess the efficacy of a diet and exercise intervention before and/or during~          pregnancy in the prevention of GDM and its fetal complications in women with high~          diabetes risk.~        2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention~          of GDM from a socio-economic point of view. To find out whether the intervention can be~          used to reduce health care costs due to GDM and T2DM.~        3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention~          in the reduction of T2DM incidence among women with prior GDM and their offspring~      STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM~     or BMI >30 kg/m2. N= 250 + 250.~      Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30~     kg/m2. N= 250 + 250~      METHOD The Finnish multi-center randomized controlled intervention trial started in the~     maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia~     Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited.~     Half of the subjects are randomized into the intervention group and the other half act as~     controls receiving only standard antenatal care in addition to the laboratory tests taken~     and questionnaires administered by the RADIEL study.~      The active intervention arm of the study will be carried out in a structured, standardized~     manner by diabetes nurses and nutritionists specifically trained for their tasks. The~     intervention includes:~        1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well~          as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling~          on diet and exercise, setting of specific goals, follow-up of achievements, laboratory~          tests and measurements~        2. Structured group visits to nutritionist at the moment of enrollment in the study, at~          the beginning of pregnancy as well as at 6 and 12 months post partum. Additional~          individual visits are booked if needed.~        3. Services of physical activity advisors are provided by the study subjects' cities of~          residence free of charge to all who wish to receive extra counseling on exercise. If~          exercise goals are not met, study subjects book an appointment with the physical~          activity advisor.~      LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or~     limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A~     minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate~     intensity exercise (Borg 11-15). Daily household and/or transportation physical activity.~     3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber,~     low-fat dairy, vegetable fats; and use of plate model. Total energy intake: 1600-1800~     kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.~      MEASUREMENTS of maternal variables:~      AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:~      (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT,~     fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background~     questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1).~     Exercise diaries daily for one week.~      PREGNANCY At the end of each trimester: (1) The same tests and measurements as in~     pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D~     questionnaire, EDPS (=Edinburgh post-partum depression scale) questionnaire for screening~     mood disorders at H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at~     H10-13 and H34-36.~      POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same~     follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post~     partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits.~     (5) Food and exercise diaries at 12 months post partum.~      MEASUREMENTS of child's variables at birth~      (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery,~     Apgar scores, any perinatal complications, operations, need of neonatal intensive care and~     length of hospital. (3) Laboratory tests from cord blood.~      TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800~     subjects had been recruited to the study. Intervention will continue until 2014 (including~     pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts~     starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis~     starts in autumn of 2013 and results will be reported from 2014 onwards in international~     peer-reviewed journals.~   "
103805|NCT01698372|"~     This study will test the effectiveness of negative pressure wound therapy (using the VAC~     Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary~     Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention~     may decrease the incidence of wound infection and non-infectious wound complications. It may~     decrease wound discomfort and improve mobility and functional recovery of the leg.~   "
103806|NCT01698359|"~     Muscle-invasive bladder cancer affects over 3,000 new patients in the UK each year and~     radiotherapy comprises a key part of the treatment pathway for many of them. Bladder~     radiotherapy in the UK involves delivery of radiation to the entire bladder volume and aims~     to deliver a high dose to the bladder while sparing nearby healthy organs (e.g. the bowel).~     Unfortunately, large variations in bladder shape and volume are observed throughout~     treatment that compromise the probability of a positive outcome for the patient, either by~     increasing the risk of side-effects or by reducing the likelihood of adequately treating the~     disease.~      In recent years, the implementation of 'adaptive' bladder radiotherapy strategies has~     increased. These techniques allow modification of the treatment based on the observed~     variations in bladder shape and volume. However, these strategies often rely on daily X-ray~     imaging of the patient prior to treatment, which is time-consuming and associated with a~     small risk of inducing a cancer in the patient.~      This study will evaluate the potential of a commercially available ultrasound probe for use~     as an alternative to X-ray scanning during treatment for these patients. The study will also~     aim to compare the likelihood of reducing side-effects and successfully treating the disease~     for the different adaptive strategies that are used around the world.~   "
103807|NCT01698346|"~     Despite good vaccination coverage, included in national immunization programs in developed~     countries, the number of reported pertussis cases is rising, also in very young infants.~     Current immunization strategies fail to protect infants too young to be immunized with the~     licensed vaccine. Different strategies are possible to close the gap of susceptibility~     between the loss of maternal antibodies and protection by vaccination. The main aim of the~     present study is to measure the influence of an adult pertussis booster in pregnant women,~     on the titer and duration of maternal antibodies in their infants. Early humoral immunity~     will be assessed and the influence on vaccine response of the infant measured. The present~     study offers the opportunity to have new insights in neonatal immunological mechanisms~     against pertussis and a better understanding in strategies to protect infants against~     pertussis.~   "
103808|NCT01698333|"~     Adrenal suppression effects of corticosteroids are among the most important safety concerns~     for this group of products. This study is designed to determine the adrenal effects of the~     investigational formulation of 122-0551 and characterize the steady state pharmacokinetics~     of the formulation.~   "
103809|NCT01698320|"~     The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks~     during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period~     followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®~     device performance through the life of the device during the study.~   "
103810|NCT01698307|"~     Assess if the implementation of an enhanced treatment algorithm will improve the management~     Crohn's Disease compared to a conventional Step-care approach.~   "
103811|NCT01698294|"~     This randomized clinical trial studies biomarkers in post-menopausal women receiving~     flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants~     receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.~   "
103812|NCT01698281|"~     This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard~     single agent cytotoxic chemotherapy (SSCC) as measured by the median time of~     progression-free survival (PFS) in patients with chemotherapy refractory triple negative~     (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.~   "
103813|NCT01698268|"~     Study measures the difference in pain after hernia &/or hydrocele repair based on site of~     local anesthesia injection.~   "
103814|NCT01698255|"~     This randomized pilot study will test the feasibility of a behavioral intervention for late~     life depression. Enrolled participants will receive 9 weeks of a specialized form of~     psychotherapy we call ENGAGE or standard of care psychotherapy. ENGAGE is a stepped care~     psychotherapy based on what is currently known about older adults' response to depression~     interventions. Stepped care is a model of treatment that starts with the minimum effective~     therapeutic techniques first, and then based on how well people respond to treatment,~     additional therapeutic techniques are added until individuals recover from their depression.~     The treatment components of ENGAGE were selected to match the most common problems seen in~     older adults with depression. They include instructing the participant in basic problem~     solving techniques and encouraging re-engagement in rewarding activities.~      Participants will be depressed, older adult clients of Westchester Jewish Community Services~     or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry.~     In addition to receiving therapy, study participants will also undergo research assessments~     at the beginning of the study and then at weeks 6 and 9.~   "
103815|NCT01698242|"~     The purpose of this study is to test whether a culturally sensitive self-management (SM)~     intervention, compared to an education only control, will reduce all-cause hospital days in~     patients with mild to moderate heart failure and household income less than $30,000 per~     year.~   "
103816|NCT01698229|"~     The purpose of this study is to obtain cerebrospinal fluid from healthy children already~     undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy~     controls when compared to children with late infantile neuronal ceroid lipofuscinosis~     (LINCL), a fatal neurodegenerative disease.~   "
103817|NCT01698216|"~     The aim of this study is observation of effectiveness and side effect of patients with~     schizophrenia who will switch the antipsychotics from risperidone long acting injection to~     paliperidone palmitate.~   "
103840|NCT01697917|"~     The purpose of this study is to find out more about differences of the quality of life in~     patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of~     esophagogastric junction. To find a better reconstruction for patients who received total~     gastrectomy.~   "
103852|NCT01697722|"~     This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of~     asthma management in patients with evidence of persistent asthma following an increase in~     asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)~     using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised~     metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS~     plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone~     propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and~     BAIs.~   "
103818|NCT01698203|"~     Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is~     contraindicated in certain patients. An alternative is continuous wound catheter analgesia.~     We will investigate whether ropivacaine, administered through a wound catheter placed by the~     surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult~     patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be~     randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%~     ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or~     saline at the same scheme of administration. Patients will also benefit from~     patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),~     paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary~     endpoints will be pain intensity on a visual analog scale at rest and on coughing and side~     effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the~     nurses and caring staff involved in this study will be blinded. Solutions of saline and~     ropivacaine will be prepared identically by the central pharmacy, without any possible~     identification of the product.~   "
103819|NCT01698190|"~     The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is~     more efficacious and cost-effective than the other while maintaining diagnostic accuracy in~     the setting of solid gastrointestinal lesions.~   "
103820|NCT01698177|"~     Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The~     Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the~     U.S each year related to the flu. Public health campaigns advocate widespread vaccination~     for the flu, and especially for high risk people. People with cancer are high risk, with an~     increased risk of developing complications from the flu, such as pneumonia, bronchitis, or~     worsening of other medical conditions. As part of their vaccination campaign, the CDC~     strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly,~     Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients~     for vaccination prior to discharge. While physicians or patients can opt not to vaccinate,~     the default is to proceed. Surgical oncologists have several concerns about vaccinating~     their patients after major surgical procedures. Patients with cancer have impaired immunity,~     and the ability of our patients to mount an effective immune response to the vaccine is~     unclear. Conversely, due to their immunocompromised state, our patients may be more~     susceptible to complications from the vaccine, such as influenza-like-illness (ILI), or have~     higher rates of postoperative complications due to the additional immune challenge of the~     vaccine. Previous studies have evaluated the flu vaccine in patients receiving chemotherapy,~     or after organ transplantation, but the combination of cancer and major surgery remains~     unstudied.~      This is a collaborative study with Infectious Diseases and Microbiology to evaluate the~     response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue~     sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon~     cancers). Patients will be randomly selected to receive the vaccine either 2 weeks~     preoperatively or postoperatively at the time of discharge. Serum antibody response, rates~     of ILI and post-op complications will be analyzed. The long term goal of this study is~     two-fold: to determine the optimal time to vaccinate this group of patients in relation to~     their surgery, and to improve compliance with vaccination.~   "
103821|NCT01698164|"~     This study is to evaluate the benefit/risk of hormone replacement treatment among early~     menopausal women in China. This is a multi-centre, random, prospective study.~   "
103822|NCT01698151|"~     This is an observational study in primary care aiming to validate biomarkers for chronic~     obstructive pulmonary disease (COPD).~   "
103823|NCT01698138|"~     This study is a double blind, randomized, placebo controlled trial to explore the effect of~     early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord~     injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20~     patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30~     ml NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the~     same procedure. The treatment will be repeated after three months. All included patients~     will be evaluated with urodynamic examinations. Follow-up is 12 months after the first~     treatment. The primary endpoint of the study is development of NDO.~   "
103824|NCT01698125|"~     The purpose of this study is to study aspects of autonomic cardiovascular control and the~     level of stress hormones and inflammatory markers in saliva or serum, in elderly patients~     exposed to elective, major abdominal surgery, with or without postoperative delirium, to~     explore the hypothesis that delirium may be the result of aberrant stress responses.~   "
103825|NCT01698112|"~     This project is a clinical intervention trial that will determine the role of a functional~     food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People~     with pre-diabetes have high blood glucose levels since their cells do not respond to insulin~     as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have~     increased risk for heart and kidney diseases. Although the long-term complications~     associated with type 2 diabetes are well-recognized, clinicians and researchers are now~     realizing that some long-term damage to the body, especially the heart and circulatory~     system, may already be occurring during pre-diabetes. Consequently, clinicians are~     recognizing that glucose control, through diet, exercise and, if necessary, medications, is~     as important for people with pre-diabetes as it is for people with type 2 diabetes.~      Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs.~     A possible treatment that could be added to the standard treatments is intake of flaxseed.~     Few studies have looked at the effect of flaxseed intake on glucose control and those that~     have enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's~     affect on controlling blood glucose in people with pre-diabetes. Therefore, more research is~     needed to determine if flaxseed is an effective means of controlling glucose levels in~     people with pre-diabetes.~      This study will help determine whether or not eating modest amounts of flaxseed every day~     will improve blood glucose and insulin levels in overweight or obese men and postmenopausal~     women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of~     inflammation they are experiencing.~      If flaxseed consumption does help control blood glucose levels in people with pre-diabetes~     and reduce the degree of inflammation they are experiencing, it may help prevent or delay~     their progression to type 2 diabetes.~   "
103826|NCT01698099|"~     Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated~     appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in~     discriminating between perforated and simple/no appendicitis.~      Methods:~      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to~     August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin~     levels to detect perforated appendicitis.~   "
103851|NCT01697735|"~     Statins are cholesterol-lowering medications that are often prescribed for patients with~     high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many~     patients whose hyperlipemia are not well controlled. If investigators are simply doubling~     the statins, that only 6% of the benefit can be received. And it often has significant side~     effects in elder patients. Several studies have suggested that the use of berberine can~     effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly,~     and the side effects are seldom, the price of berberine is very cheap. The purpose of this~     study is to observe the therapeutic effects of combination of statins and berberine on the~     patients with hyperlipemia whose level of the lipid are not well controlled when only using~     statins.~   "
103889|NCT01697241|"~     The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis~     postpone time to hip replacement surgery following participation in a patient education and~     supervised exercise program when compared to patients receiving patient education alone.~   "
103827|NCT01698086|"~     Impaired standing balance, fatigue and abnormal eye movements are common problems in persons~     with MS. These complaints are related to advanced disability and decreased quality of life~     for persons with MS. Researchers from the University of Colorado and the Rocky Mountain~     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and~     published a research study that showed an exercise program consisting of balance and eye~     movement training, referred to as a vestibular rehabilitation program, was very effective in~     improving self-reported fatigue and standing balance in persons with MS. This initial study~     was the first to have proven that this type of exercise program is able to improve both of~     these potentially devastating complaints.~      The investigators from this initial study have partnered with other well-established~     researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain~     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of~     the effect of vestibular rehabilitation for persons with MS. Using the findings from the~     initial study, the investigators propose to conduct a larger study specifically identifying~     persons with MS who have brain lesion involvement in areas that control balance and eye~     movements. Primarily, the current study will determine if those individuals who have~     involvement in these areas of the brain improve more in balance and fatigue compared to~     those who do not following participation in a vestibular rehabilitation program.~     Additionally, the investigators will test if study participants who have abnormal eye~     movement control, will improve their eye movement control following the training program.~     For persons with MS, impaired eye movements can lead to a considerable decline in health~     status, further illustrating the importance of the research plan to study this important~     factor.~      The investigators believe that greater improvements in balance and fatigue are possible from~     a longer treatment, and that participants who have brain lesion involvement in areas that~     help control balance and eye movements will benefit greater than those who do not. This~     information is important to determine who is more likely to benefit from a vestibular~     rehabilitation program. Additionally, the researchers will be able to measure changes in eye~     movement control, providing valuable insight into the reasons for the program's~     effectiveness.~   "
103828|NCT01698073|"~     Youth who participate in the Circle of Life (COL) program will report less sexual risk~     taking behavior compared to youth who do not receive the program.~   "
103829|NCT01698060|"~     The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted~     adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a~     radio controlled capsule. The secondary objective is to evaluate the immune response~     (cellular and humoral) of two doses of ND1.1 oral vaccine.~   "
103830|NCT01698047|"~     The purpose of this study is to build a scientific evidence base for the training and~     delivery of a depressive symptoms education program, developed by local community members,~     called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy~     and is designed to be delivered as a psycho-educational class by non-professionals to~     improve mood. Depressive symptoms are common, especially in low-income, minority~     communities. Depressive symptoms that don't meet DSM-IV criteria for Major Depression still~     carry a significant amount of disability. Interventions that address sub-threshold~     depressive symptoms have been noted to result in a decreased likelihood of depression and~     diminished use of mental health services. Few interventions using a health education /~     health promotion focus are designed to be delivered by non-professionals to address~     individuals with mild to moderate depressive symptoms in low income, minority communities.~     This project will take place in the Centinela Valley, which roughly corresponds to Service~     Planning Area (SPA) 6 or South Los Angeles (SLA). This single-blind, randomized trial will~     utilize a wait-list control design where half of the participants enrolled in the study will~     be randomized to the Resiliency Class (7 sessions) and half will go to a wait-list control~     condition where they will receive 2 case management calls and referrals to social services.~     We propose to screen 1500 clients to detect about 450 participants with depressive symptoms~     (endorsed one item on the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency~     class and 200 in the wait-list control condition. Primary outcomes measures will include~     depressive symptoms, function, and measures of resiliency. We will assess these measures at~     baseline and at 3 months after completion of the Resiliency Class or wait-list condition.~     After the completion of the first round of classes, we will conduct a preliminary analysis~     of the impact of the resiliency classes versus the wait-list control case management calls~     on depressive symptoms. If the resiliency classes improve depressive symptoms more than the~     wait-list control, we will offer wait-list controls access to the resiliency classes and~     then disseminate the resiliency class through trainings.~      We hypothesize that the resiliency classes will lead to greater reductions in client~     depressive symptoms than the wait-list case management calls in the randomized trial of this~     project.~   "
103831|NCT01698034|"~     This study tested whether getting youth engaged in helping others (volunteering) would~     benefit youth's physical health. 106 predominantly minority and low socioeconomic status~     (SES) youth were randomized to either volunteer weekly with elementary school children in~     after school programs or to a wait-list control group. The investigators hypothesized that~     cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total~     cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after~     baseline) in the volunteer group compared to the control group. The investigators also~     hypothesized that the intervention might work through pathways such as reducing negative~     mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).~   "
103832|NCT01698021|"~     The new assay of troponins T (highly sensitive troponins) detects concentrations much lower~     than before. Few data are currently available on their kinetics during acute coronary~     syndrome, especially in regard to the correlation with CK MB. The aim of the present study~     is to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to~     correlate it with the concentration of CK MB, and possibly to evaluate their prognostic~     value with respect to infarct size .~   "
103833|NCT01698008|"~     Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are~     between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in~     the study. Subjects will be randomized to two groups - iPhone versus standard of care and~     seen in our clinic at an initial/baseline and three month clinical visit. The control group~     will e-mail, fax, or call their blood glucose log results once a month for an insulin~     regimen adjustment through verbal communication with a certified diabetic educator once a~     month as is already implemented at the Diabetes Center. This group will be compared to the~     intervention group who will submit their blood glucose log results through an iPhone mobile~     application, called Diabetes Doctor, once a month for an insulin regimen adjustment by a~     physician with a text message response. The two groups will have their HbA1c, hypoglycemic~     events, blood glucose dispersion compliance, quality of life, usability and satisfaction~     with the use of a mobile application will be assessed at each visit with surveys.~   "
103834|NCT01697995|"~     The objectives of this study are to determine the:~        1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to~          Exercise stress MPI in predicting a significant CAD.~        2. Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting~          adverse short-term and long-term clinical outcomes after the index test.~   "
103835|NCT01697982|"~     Hope is important to palliative home care patients. Our research team has developed a Living~     with Hope Program that has been found to increase hope and quality of life in older persons~     with advanced cancer.~      The investigators want to know if this program increases hope and quality of life for all~     palliative home care patients (all ages, all diagnosis). Thirty palliative home care~     patients and their care partners will participate in this pilot study to evaluate the study~     procedures and the living with hope program.~   "
103836|NCT01697969|"~     The purpose of this study is to descriptively evaluate the corneal structures of allergic~     conjunctivitis patients.~   "
103837|NCT01697956|"~     The purpose of this study is to compare the effect of 6 weeks of treatment with~     beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as~     assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and~     tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic~     rhinitis.~   "
103841|NCT01697904|"~     Preterm infants are born with immature lungs and often require help with breathing shortly~     after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery~     of high oxygen concentrations leads to the production of free radicals that can injure many~     organ systems. Term and near-term newborns deprived of oxygen during or prior to birth~     respond as well or better to resuscitation with room air (21% oxygen) compared to 100%~     oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm~     infants with lung disease.Purpose of the study is to investigate if preterm neonates where~     resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations~     (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the~     oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to~     infants where resuscitation is initiated with pure oxygen and titrated for targeted~     saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest~     included need for other delivery room resuscitation measures, respiratory support and~     ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival~     to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.~   "
103842|NCT01697891|"~     Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation~     completion, can improve radiation-induced dysphagia and associated symptoms in head and neck~     cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory~     response of swallowing musculature to radiation, consequently a reduction in muscle~     fibrosis.~      Primary study objective: To evaluate the effectiveness of ALTENS in relieving~     radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this~     primary study endpoint.~   "
103843|NCT01697878|"~     The investigators propose to compare two different treatments, continuous positive airway~     pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep~     apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE~     hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with~     desaturation and the investigators expect that post-operative CPAP treatment in the PACU~     will significantly improve the AHI and therefore improve patient safety in the PACU. The~     investigators also hypothesize that subjects with OSA have a greater decrease in oxygen~     saturation in response to opioid administration by patient-controlled opioid analgesia~     (PCA).~   "
103844|NCT01697865|"~     The overall objective of this study is to compare the clinical benefit and safety of two~     different surgical techniques of primary reverse total shoulder arthroplasty for the~     treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated~     teres minor dysfunction. The first surgical technique includes a concomitant latissimus and~     teres major transfer (transfer group) and the second technique does not include a~     concomitant latissimus and teres major transfer (control group).~   "
103845|NCT01697852|"~     The study is a cluster randomised trial to compare the effectiveness of indoor residual~     spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the~     effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary~     outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years,~     measured in cross sectional surveys. Secondary outcomes include relative population density~     for each mosquito vector species, malaria transmission as measured by entomological~     inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers~     including kdr, and user acceptability of LLINs compared with IRS.~      Findings from this study are expected to inform decision making so that resource utilization~     can be optimised.~   "
103846|NCT01697839|"~     This is a prospective study investigating the relationship between vitamin D and peripheral~     neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or~     thalidomide. The study consists of a screening period of up to 14 days, followed by a single~     assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic~     pain, and markers of depression. Patient charts will also be utilized to assess the~     frequency of skeletal-related events.~   "
103847|NCT01697826|"~     Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and~     tolerability of 2 different vaginal formulations containing 200mg clotrimazole and~     clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically~     diagnosed to have infective vaginitis.~   "
103848|NCT01697800|"~     Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year~     survival estimates of approximately 50%, and is associated with a high rate of systemic~     immune impairment as well as evasion of a tumor specific immune response. Preclinical and~     clinical data have shown that PDE5 inhibitors (tadalafil) can be used to augment immune~     function in HNSCC patients through inhibition of the cancer-induced myeloid derived~     suppressor cells (MDSCs).~      A multi site phase II, randomized, prospective, biomarker endpoint trial to determine~     optimum timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with~     conventional therapy for HNSCC.~      40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or~     placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing~     until 90 days after completion of conventional therapy. Tumor-specific T cell responses will~     be assessed using HNSCC cell lines, in blood collected before initiation of~     tadalafil/placebo and at 60 and 90 days after completion of conventional therapy. Number and~     function of MDSC and Treg cells will be assessed before and at 60 and 90 days after~     completion of conventional therapy. Prevnar 13® vaccine will be administered 10-14 days~     after commencing tadalafil/placebo (before conventional therapy begins) and again at 60 days~     after completion of conventional therapy. Vaccine-specific responses assessed at 60 and 90~     days post-conventional therapy will be used to measure the ability of tadalafil to augment~     immune response to vaccine.~   "
103849|NCT01697787|"~     This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of~     Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy~     positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the~     Rapid Diagnosis Tests (RDTs) compared to the microscopy.~   "
103850|NCT01697761|"~     The purpose of this study is to determine whether acupuncture or moxibustion therapies are~     effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the~     content of Inflammatory factors and Neurotransmitter before and after acupuncture and~     moxibustion therapy.~   "
103853|NCT01697709|"~     Despite a benign public perception, marijuana use disorders represent a significant public~     health problem. The development of safe and effective pharmacotherapies for marijuana~     dependence is an important unmet public health need. Quetiapine, an effective atypical~     antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1,~     and adrenergic receptors, is a promising treatment for substance use disorders. In animal~     models, quetiapine blocks the enhancement of reward by cocaine, which is likely due to its~     actions on both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine~     have shown benefit for the treatment of alcohol and cocaine use disorders.~      Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis,~     mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana~     withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the~     treatment of marijuana dependence conducted by our research group determined that quetiapine~     was well-tolerated and associated with reductions in marijuana use indicating that it is a~     promising agent deserving of further study in marijuana-dependent outpatients.~      The proposed research project is a randomized double-blind placebo-controlled clinical trial~     to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a~     12-week period. All participants will receive Medical Management, a medication adherence~     focused psychosocial intervention that facilitates compliance with study medication and~     other study procedures, promotes abstinence from marijuana and other substances, and~     encourages mutual-support group attendance. All participants will receive voucher incentives~     for compliance with study visit attendance, returning study medication bottles, and~     completing other study procedures, with the objective of achieving a highly compliant~     sample. The goal of this phase II clinical trial is to build on our promising open-label~     pilot study results and examine the efficacy of quetiapine on participants' marijuana~     consumption under placebo-controlled double-blind conditions using an abstinence-initiation~     model, where participants will be using marijuana regularly at study entry, reduce their~     use, and then achieve abstinence. The specific aims of the projects are to determine whether~     quetiapine is superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.~   "
103854|NCT01697696|"~     The purpose of the study is to provide long term safety data of NVA237. This study will~     assess the safety and tolerability of a single dose strength of NVA237.~   "
103855|NCT01697683|"~     This study will add to the current knowledge and literature on the ability of an oral~     lactobacilli preparation to return the vaginal flora to a normal state in pregnant women.~     The results will potentially serve as the basis for a multi-centre Phase III randomized~     clinical trial to determine the efficacy of this treatment in preventing preterm birth.~   "
103856|NCT01697670|"~     Objectives:~      Primary: The primary study objective is to determine a clinical response as assessed by the~     Mayo score to low dose PDT in patients with moderate to severe active distal UC.~      Secondary: The secondary study objectives are to assess the effect on inflammation and the~     safety and tolerability of low dose PDT in patients with moderate to severe active distal~     UC.~      This is a multicenter, open phase II study that will enroll a maximum of 20 eligible~     patients with moderate to severe active distal UC. The first 10 eligible patients, the first~     cohort, will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no~     clinical response is observed in the first 7 eligible patients, the study will be stopped~     due to lack of efficacy. If at least 1 clinical response is observed in the first 7~     patients, the first cohort will be completed to a total of 10 eligible patients~        -  Trial with medicinal product~   "
103857|NCT01697657|"~     This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to~     investigate whether insulin detemir combined with insulin aspart compared to NPH insulin~     combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst~     maintaining the same degree of glycaemic control subjects with type 1 diabetes.~   "
103858|NCT01697644|"~     This trial is conducted in Europe. The aim of this trial is to assess and compare the~     efficacy and safety of two dose levels of somatropin over a long period (till final height~     is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial~     trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).~   "
103859|NCT01697631|"~     This this trial is conducted in Europe. The aim of this trial is to compare glycaemic~     control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp)~     in patients previously treated with conventional Biphasic Human Insulin 30/70.~   "
103860|NCT01697618|"~     This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics,~     pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.~   "
103861|NCT01697605|"~     This study will evaluate safety and tolerability to determine the Maximum tolerated dose~     (MTD) and/or Recommended dose (RD).~   "
103862|NCT01697592|"~     This study will examine the safety and efficacy of the addition of omarigliptin in Japanese~     participants with type 2 diabetes mellitus who have inadequate glycemic control on~     diet/exercise therapy and oral antihyperglycemic agent monotherapy.~   "
103863|NCT01697579|"~     The purpose of this study is to determine the appropriate dosing regimen of fosaprepitant,~     when administered with ondansetron (with or without dexamethasone), for the prevention of~     CINV in children from birth to <17 years of age (changed to birth to <12 years of age in~     Amendment 04). Fosaprepitant is a prodrug to aprepitant. All participants who complete the~     randomized Cycle 1 may elect to receive open-label fosaprepitant during optional Cycles 2-6.~   "
103864|NCT01697566|"~     The goal of this clinical research study is to learn about the effects of metformin and/or a~     program called lifestyle intervention on the endometrium (inner lining of the uterus) in~     post-menopausal women who are also obese (both are risk factors for endometrial cancer).~     Researchers also want to learn how insulin levels will be affected by metformin, diet and/or~     exercise.~      Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a~     condition in which the body makes insulin but does not use it properly. It is often referred~     to as pre-diabetes. Many people with insulin resistance have high levels of both sugar and~     insulin in their blood at the same time, which have been reported in patients with~     endometrial cancer.~      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to~     be compared with a study drug to learn if the study drug has any real effect.~      Lifestyle intervention is made up of a series of in-person sessions where you meet with a~     coach to discuss strategies for losing weight and ways to increase physical activity. It~     also consists of materials designed to help you lose weight and will offer opportunities for~     supervised exercise.~   "
103890|NCT01697228|"~     The investigators are conducting a prospective cross-over study to evaluate the effects of~     vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in~     microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to~     see a significant improvement in glycemic control and a reduction of serum pro-inflammatory~     markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who~     are treated with vitamin D.~   "
133574|NCT01306578|"~     Comparing whether intravenous immune globulin or plasma exchange is superior in treating~     mechanically ventilated children with Guillain Barre syndrome.~   "
103865|NCT01697553|"~     The growth of the elderly population is associated with the autonomy failure and the~     increase of dependence problems. Fall incidents are the third cause of chronic disablement~     in older persons and are one of the major risk factors for entering in dependence.~      The recent progress in home technologies and medical care are opportunities to search how to~     apply these tools to reduce and prevent falling at home.~      The purpose of this study is to evaluate the cost effectiveness of simple home automation~     pack coupled to teleassistance service for preventing home falls in frail elderly~     population.~      1200 patients will be enrolled and randmosied within two arms:~        -  home with automation pack coupled to teleassistance service~        -  home without this technology~   "
103866|NCT01697540|"~     1. Written informed consent must be obtained before any study specific procedures are~          undertaken.~        2. The process of the experiment (brief describe) The patients must come back for follow~          during 4 to 12 weeks after starting the new therapy. The investigators will follow the~          patients' lipid profile and any side effects and stop the observation till 36 months~          after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride,~          cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The~          patients' chart and all data will be delinked to protect the patients' right and~          privacy.~   "
103867|NCT01697527|"~     This phase II trial will examine whether genetically reprogramming a patient's disease~     fighting white blood cells may build an immune response to kill cancer cells that express~     the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell~     transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein~     and may help to stimulate the engineered immune response to tumor cells.~   "
103868|NCT01697514|"~     The purpose of this study is to find a recommended dose level of LY2940680 that can be~     safely given to children with medulloblastoma or rhabdomyosarcoma that has returned or~     doesn't respond to initial treatment. The study will also explore the changes in a cancer~     marker levels. Finally, the study will help document any antitumor activity.~   "
103869|NCT01697501|"~     This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with~     HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the~     predecessor ML18253 study. The study consists of a single visit where eligible patients will~     undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.~   "
103870|NCT01697488|"~     This observational study will evaluate the safety, efficacy, quality of life and~     predictive/selection factors for Avastin (bevacizumab) in combination with~     carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian~     tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be~     collected during up to 15 months of treatment and 12 months of follow-up. A second~     recruitment phase has been opened to focus on patients >/= 70 years.~   "
103871|NCT01697475|"~     This study examined the impact of using a motivational mobile text messaging intervention to~     increase step count among older community-dwelling African Americans. Secondary aims were to~     study the effects of text messaging on self-reported leisure time exercise behavior.~      Hypothesis:~      Participants in the motivational mobile text messaging group will have an increase step~     count after 6-weeks.~   "
103872|NCT01697462|"~     This prospective observational study will evaluate the safety and efficacy of Xeloda~     (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer.~     Patients will be followed until disease progression or unacceptable toxicity occurs.~   "
103873|NCT01697449|"~     This prospective observational study will evaluate the safety and efficacy of Avastin~     (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from~     patients receiving Avastin in combination with chemotherapy according to registered~     indication in routine clinical practice.~   "
103874|NCT01697436|"~     This four-period, single-center, open-label, single-dose, randomized, cross-over study will~     assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to~     a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four~     sequences in which they will receive the treatment under fed and under fasted conditions.~   "
103875|NCT01697423|"~     The incidence of cartilage pathology has grown due to the ageing population, and the~     increase in sports participation and its associated trauma. The aim of the treatment of~     symptomatic osteoarthritis consists in reducing pain and improving the knee function in~     order to limit the sport, professional and social negative impact in the youngest patients.~      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti~     inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular~     injections are proposed.~      Intra articular injections of hyaluronic acid are recommended by the American College of~     Rheumatology and the European League against Rheumatism for the treatment of knee~     osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the~     duration of clinical improvement which does not exceed 6 months.~      The articular cartilage has a limited capacity for self-repair due to the low mitotic~     activity of chondrocytes and its avascularity.~      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and~     the cytokines, liberated by platelet degranulation. The influence of these growth factors in~     the cartilage repair is being widely investigated in vivo and in vitro. These factors could~     stimulate the chondral reparation via a neovascularization, a collagen synthesis and an~     activation of the chondrocytes.~      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance~     articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the~     treatment of knee osteoarthritis resisting the oral drugs.~      Material and methods: We intend to conduct a comparative, monocentric prospective~     randomized, double-blind study on 80 patients with symptomatic knee osteoarthritis to~     compare the results of 2 intra articular treatment: platelet-rich plasma and hyaluronic~     acid.~   "
103876|NCT01697410|"~     The purpose of this study is to evaluate the efficacy of terlipressin for treating septic~     shock.~   "
103877|NCT01697397|"~     A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity~     in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI~     pain and asymptomatic subjects without IBS and GI pain.~   "
103878|NCT01697384|"~     Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant~     (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer~     during 52 weeks of treatment with the implant. After consultation w/ FDA, design was~     modified to eliminate the Lupron arm and continued the study as an open-label non-randomized~     study.~      Primary endpoint was testosterone suppression, as assessed by the percent of patients whose~     testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment~     with an implant.~   "
104514|NCT01689090|"~     The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins~     affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are~     studied using the Dynamic Vessel Analyzer.~   "
103879|NCT01697371|"~     Local control of hepatic metastases appears to be a major determinant of overall survival.~     However, many patients are not suitable for resection due to medical or surgical reasons.~     Therefore, there is an important role for a treatment that can provide the equivalent of~     tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an~     ablative regimen of highly focused external beam radiotherapy that targets one or more~     discrete extracranial lesions. Published reports using SBRT to treat liver metastases have~     shown actuarial local control rates ranging from 50-100% with higher doses associated with~     better local control.~      In patients with metastatic liver disease, aggressive local therapy using modern~     radiotherapy techniques are promising and project to have a substantial role in the~     treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage~     of proton therapy may lead to improved clinical outcomes with less morbidity, however, there~     is no clinical data to confirm this assertion. We thus propose a phase I study to determine~     the feasibility and safety of stereotactic body proton therapy in patients with liver~     metastases followed by a phase II study to determine the efficacy of such treatment on local~     control.~   "
103880|NCT01697358|"~     The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS)~     using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management~     (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed~     back surgery syndrome (FBSS).~   "
103881|NCT01697345|"~     It is well documented that women who have breast cancer may experience a decrease in quality~     of life and sexual functioning due to side effects from adjuvant endocrine therapy,~     typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant~     urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This~     treatment can impair sexual functioning and cause a decreased sexual health quality of life.~      At the present time, there are no Food and Drug Administration (FDA) approved medications~     for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment~     options is concerning because the number of women diagnosed with breast cancer continues to~     increase; their longevity, also, continues to increase with the use of newer adjuvant~     chemotherapies. Local health care practitioners have observed that the benefits of vaginal~     testosterone for sexual health in breast cancer survivors are similar to the benefits of~     vaginal estrogen in women without breast cancer.~      The purpose of this study is to evaluate the impact of using a daily compounded vaginal~     testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of~     vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and~     sexual functioning.~   "
103882|NCT01697332|"~     The overall objectives of our study are to determine the capabilities of hyperpolarized~     129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease~     and its progression in COPD. We hypothesize that measurement of alveolar surface area,~     septal thickness, and capillary transit time measured with hyperpolarized 129Xe will~     correlate better with quality of life measures in COPD subjects than traditional diagnostic~     measures such as spirometry and Computed Tomography.~   "
103883|NCT01697319|"~     The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a~     patient population that has limited ambulation, in a period of up to 144 weeks.~   "
103884|NCT01697306|"~     To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and~     intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was~     to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive~     (NMIBC) patients treated with BCG or gemcitabine.~   "
103885|NCT01697293|"~     This phase I/II trial studies the side effects and the best dose of triciribine phosphate~     when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to~     see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine~     phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and~     cyclophosphamide may be a better treatment for breast cancer.~   "
103886|NCT01697280|"~     This study aims to assess if pictorial messages promoting routine immunization during~     supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can~     improve immunization rates. A cluster randomized trial design in low literature populations~     will be used.~   "
103887|NCT01697267|"~     Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody~     (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its~     effect wears off and the disease can return. This occurs in at least half of patients within~     2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that~     repeating rituximab every six months stops the disease returning and is safe.~      The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and~     whether it works better than the older treatments, azathioprine or methotrexate. It will~     also tell us how long patients remain well after the repeated rituximab treatments are~     stopped, and if repeated rituximab is safe. We should also learn useful information about~     the effects of rituximab on quality of life and economic measures. The trial results will~     help decide the best treatment for future patients who have their vasculitis initially~     treated with rituximab.~      RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come~     back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we~     anticipate that most will respond well. If their disease is under reasonable control after~     four months, further treatment with either rituximab (a single dose ever four months for two~     years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and~     azathioprine groups will then be compared. Patients will be in the trial for four years.~      The study has been designed by members of the European Vasculitis Study group (EUVAS) and~     the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30~     hospitals in Europe, the USA, Australia and Mexico.~      RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health~     and by Roche/Genentech.~   "
103888|NCT01697254|"~     This CARRA Registry study will create a foundational database for rheumatic diseases of~     childhood using a novel informatics infrastructure developed as part of the larger clinical~     project. The creation of a CARRA-wide informatics infrastructure will enable efficient,~     observational, disease-related data capture across all CARRA sites for pediatric rheumatic~     diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more~     data intensive registries for observational studies, comparative effectiveness research,~     pharmaceutical clinical trials and translational research.~   "
121127|NCT01470469|"~     This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years~     with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and~     ECGs.~   "
103893|NCT01697189|"~     The general aim of the study is to promote safe, economic, and environmental-friendly~     driving among long-haul truck drivers. To do this, the investigators will conduct an on-road~     study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel~     consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at~     the wheel. The educational intervention is designed to be employed by occupational health~     care professionals in the future. This solution clearly facilitates the implementation of~     the intervention into practice if it turns out to be effective.~      The investigators specified research questions are the following:~        -  Do truck driver sleepiness and stress at the wheel reach levels that affect driving~          behaviour, fuel consumption and carbon emissions?~        -  What are the sources of sub-optimal arousal at the wheel in truck drivers?~        -  Can truck driver sleepiness be mitigated by an educational intervention, and if yes,~          does it improve driving behaviour and decrease fuel consumption and carbon emissions as~          well?~   "
103894|NCT01697176|"~     This is an observational study of lone Coronary Artery Bypass Grafting procedures with~     endoscopic vein graft harvesting using best harvesting practices.~   "
103895|NCT01697163|"~     This study is based on the following hypothesis De novo resistance to EGFR-TKI in EGFR~     mutation positive patients is related with mutations in EGFR downstream genes.~      Investigators will prospectively collect genomic DNA and clinical data regarding treatment~     outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will~     sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification~     and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification,~     and protein over expression as predictive markers of treatment outcomes, investigators~     analyzed the association of treatment outcomes with the presence of genetic alteration or~     protein over expression. Investigators will attempt to identify biomarkers that are able to~     predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.~   "
103896|NCT01697150|"~     Automated closed-loop control (CLC) of blood glucose, known as artificial pancreas (AP)~     can have tremendous impact on the health and lives of people with type 1 diabetes (T1DM).~     The investigators inter-institutional and international research team has been on the~     forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative~     in 2006. Thus far, the investigators have conducted three closed-loop control clinical~     trials (totaling 60 subjects with T1DM), which demonstrated significantly more time in an~     acceptable target blood glucose range during CLC, and significantly fewer hypoglycemic~     events during CLC compared to open loop. The investigators overall objective is to~     sequentially test, validate, obtain regulatory approval for, and deploy at home, a~     closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety~     Supervision Module (SSM) and a Hypoglycemia Mitigation Module (HMM). The SSM will monitor~     the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent~     hypoglycemia and will also monitor the integrity of continuous glucose monitor (CGM) data~     for signal sensor deviations or loss of sensitivity. The HMM will be responsible for the~     optimal regulation of postprandial hyperglycemic excursions through correction boluses.~      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and~     (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who~     are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local~     hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for~     validation that remote system monitoring can successfully occur. During the study, study~     subject will be responsible for. operating the CTR system with nursing and technicians~     available~   "
103897|NCT01697137|"~     The number of persons on the national solid organ waiting list continues to increase while~     the number of donated organs has failed to keep pace. In some portions of northeastern Ohio~     the donation rate is as low as 32%. There is a positive association between discussing organ~     donation with a primary care physician and signing a donor card. However, such discussions~     are rare. The investigators propose a blinded randomized controlled trial to evaluate the~     effectiveness of two interventions: 1) showing a donation video to patients in primary care~     settings waiting to see their physician and 2) cueing of primary care providers to have~     donation discussions with their patients. The study will be conducted throughout Cuyahoga~     County in at least 10 ambulatory clinics associated with a single county medical system.~     Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize~     that patients exposed to the interventions will be 1) more likely to consent to donate~     organs, 2) more likely to have donation discussions with their primary care providers, and~     3) equally satisfied with the time spent with their doctor compared to patients who are not~     exposed to the interventions.~   "
103898|NCT01697124|"~     The Children in Action (CIA) program was a five month physical activity intervention. This~     intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start~     centers. After baseline assessment, centers were matched by ethnicity and for number of~     participants and randomly assigned to either the intervention or the control condition. A~     total of 224 preschool children were randomly selected across the four centers. To evaluate~     the efficacy of the CIA intervention, the change in physical activity, gross motor skills~     and weight during the awake time and used mixed effect time-series regression models was~     compared. Observations did not show a statistical difference between intervention and~     control groups in physical activity level during the awake time, gross motor development or~     weight status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum~     among preschool children attending Head Start Centers but that an increased dose and/or~     longer intervention duration will be required to impact gross motor skills, weight status~     and physical activity levels during this critical early childhood development stage.~   "
103899|NCT01697111|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study~     (24-week treatment-comparison phase) with an open-label reference arm of active comparator~     (dienogest) followed by 28-week long-term treatment phase.~      The primary objective of this study is to confirm the superiority of BAY86-5300 when~     administered with an extended flexible regimen for the treatment of endometriosis-associated~     pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.~      The secondary objective is to investigate the long-term safety of BAY86-5300 in patients~     treated with an extended flexible regimen for one year, and the bleeding pattern of~     BAY86-5300 when administered with an extended flexible regimen compared to dienogest.~   "
103900|NCT01697098|"~     The investigators sought to determine whether the incidence of neonatal respiratory distress~     syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of~     dexamethasone.~   "
103901|NCT01697085|"~     Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous~     membranes~   "
123740|NCT01436019|"~     The purpose of this study is to analyze the frequency of the formation of antibodies against~     three different anti-TNF biologic agents used for the therapy of juvenile idiopathic~     arthritis.~   "
103903|NCT01697059|"~     Several recent studies have examined the feasibility and benefits of nonoperative treatment~     of perforated appendicitis in children. One such study showed a trend toward longer~     operative times for patients randomized to immediate appendectomy, but no overall advantage.~     In another larger study, the costs of delayed appendectomy for perforated appendicitis were~     higher - in part related to readmissions in the interval (6-8 weeks). Nevertheless, these~     and other studies have demonstrated the safety of delaying appendectomy for perforated~     appendicitis.~      Emergency appendectomy is a well-established approach, and postoperative recovery in~     children is fast. Nevertheless, from the onset of symptoms through the hospital stay and the~     postoperative recovery, appendicitis causes a disruption of a family's normal routine~     (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation,~     patients have to wait until an operating room becomes available, or elective operations have~     to be placed on hold to accommodate the emergency operation. Each year, more than 250~     children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery,~     or about one emergency add-on operation per working day. If an initial trial of antibiotics~     is safe for the treatment of appendicitis, converting an emergency operation into an~     elective, scheduled outpatient procedure may reduce stress and disruption of routine for~     patients and their families - and may allow better operating room planning for health care~     professionals and hospitals.~      The investigators hypothesize that initial antibiotic treatment of acute (non-perforated)~     appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of~     treating the disease and results in greater patient and family satisfaction.~      This pilot study aims to establish the safety and feasibility of treating acute appendicitis~     with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their~     families will be offered the possibility of initial nonoperative treatment and subsequent~     outpatient elective appendectomy in a nonrandomized, single arm study.~   "
103904|NCT01697046|"~     This will be a pilot, open label study involving 65 participants. All participants will be~     followed until seroconversion or until the last enrolled participant completes one year of~     follow-up, whichever happens first. Participant study number will be given at the screening~     visit, prior to inclusion in the study.~      The chosen intervention and study regimen are based on the dynamics of viral infection and~     the pharmacokinetics of the study drugs. In order to inhibit reverse transcription~     nucleoside and nucleotide analogues need to be phosphorylated intracellularly. On the other~     hand, available data indicate that it takes approximately 10 hours between exposure and HIV~     viral integration, offering a window of opportunity for Raltegravir to block integration and~     thus prevent infection, given that this drug does not need to be metabolized to exert its~     effect. The intervention will be maintained for 4 weeks following exposure, in accordance~     with Brazilian and CDC guidelines for PEP.~   "
103905|NCT01697020|"~     The primary objective of this study is to determine whether the test product, mercaptopurine~     oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are~     bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared~     after administration of a single dose of each of the two formulations, under fasting~     conditions. The secondary objective is to assess the safety and tolerability of the test~     product, mercaptopurine oral 100 mg/5 mL suspension.~   "
103906|NCT01697007|"~     Electroporation will increase the efficiency of DNA priming in terms of immune responses and~     will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine~     concentration will reduce the number of shots necessary to deliver the full dose and induce~     comparable immune responses as with lower DNA vaccine concentrations.~   "
103907|NCT01696994|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for ovarian cancer.~     The ovarian cancer screening tests are part of a trial that addresses the screening of four~     cancer sites, each with their own results record: prostate (NCT00002540), lung~     (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).~   "
103908|NCT01696981|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for colorectal~     cancer.~   "
103909|NCT01696968|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for lung cancer.~   "
103910|NCT01696955|"~     This randomized phase II trial studies how well cetuximab with or without tivantinib works~     in treating patients with head and neck cancer that has come back (recurrent), has spread to~     other places in the body (metastatic), or cannot be removed by surgery. Monoclonal~     antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and~     spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. It is not yet known whether cetuximab is more effective with or without~     tivantinib in treating patients with head and neck cancer.~   "
103911|NCT01696942|"~     Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates~     compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy~     for Crohn's disease.~        1. To evaluate the difference in clinical recurrence rates between certolizumab and~          mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following~          ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI).~        2. To compare the endoscopic recurrence rates at one year following surgery between~          patients treated with certolizumab and mesalamine.~        3. To compare medication side-effects and tolerance of therapy, including the need to~          interrupt therapy due to side-effects, the incidence of opportunistic infections, and a~          general assessment of each patient's health and well-being using the short-form 36~          (SF-36).~   "
103924|NCT01696773|"~     Eating a diet rich in tomatoes has been associated with decreased risk for a variety of~     diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of~     pigments called carotenoids), which has been associated with the decreased risk of disease~     in those consuming tomato products; however, tomatoes also contain flavonoids, which may~     also have health promoting effects. The Tangerine tomato, a unique tomato variety, contains~     lycopene in a different form that in red tomatoes and this contributes to their~     characteristic orange color. This orange lycopene is more similar to the most common form~     of lycopene found in the blood and tissue of people who eat a tomato-rich diet, and may be~     more easily absorbed by the body.~      The objectives of this study are to determine if carotenoids and flavonoids from Tangerine~     tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating~     Tangerine versus red tomatoes impacts markers of inflammation (response to harmful~     substances by the body).~   "
104221|NCT01692899|"~     To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy~     in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated~     factors, and retention rates of possible second-line tumor necrosis factor α inhibitors~     (TNFi).~   "
103912|NCT01696929|"~     This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy~     of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients~     with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a~     recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the~     immunoglobulin (Ig) gamma-1 subclass. Tocilizumab is formulated as a concentrate for~     solution for infusion, and will be administered by intravenous infusion.~      The investigators propose an 8-week trial to determine the safety, tolerability, and~     effectiveness of tocilizumab, given in addition to antipsychotic medications, in 10 stable~     outpatients with schizophrenia. The investigators hypothesize that tocilizumab will be~     associated with clinically significant improvement in cognition and total psychotic symptoms~     over the course of the trial. Tocilizumab is administered as an intravenous infusion every 4~     weeks. Following a screening evaluation, participants will receive two infusions of~     tocilizumab, one at baseline and another at week 4 of the study. The investigators will~     measure changes in cognitive function and symptoms over an 8-week period. Complementing~     previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a~     proof-of-concept study that targeting specific cytokines is a viable treatment for~     schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical~     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for~     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,~     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.~      Data presented in 2008 showed the effectiveness of tocilizumab in combination therapy with~     methotrexate for rheumatoid arthritis treatment. In further studies, it was effective and~     generally well tolerated when administered either as monotherapy or in combination with~     conventional disease-modifying antirheumatic drugs in adult patients with moderate to severe~     rheumatoid arthritis.~   "
103913|NCT01696916|"~     The aim of this study is to investigate the development of partial pressure of carbon~     dioxide during the 6-min walking test and during night in Chronic Obstructive Pulmonary~     Disease (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide,~     oxygen saturation and the heart rate are registered by a device called Sentec during the~     mentioned periods. In addition a measurement of activity is realised by an activity monitor~     (Sensewear).~   "
103914|NCT01696903|"~     Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the~     bile system or the duodenum that is associated with a high rate of complications. The study~     wants to investigate whether a new technique to reconstruct the joint between the pancreatic~     gland and the short bowel can reduce the rate of severe complications after this complex~     surgical procedure.~   "
103915|NCT01696890|"~     The aim of this study is to evaluate this model of telemonitoring-assisted close supervision~     and interaction between first and second line health professionals versus a model of~     telemonitoring without this integrated approach.~   "
103916|NCT01696877|"~     This research is being done to see if an investigational prostate cancer vaccine, called~     GVAX, can safely be given together with a single intravenous injection of a drug called~     cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands~     who have also received standard hormonal therapy.~   "
103917|NCT01696864|"~     The objective of this study is to examine monitored rehabilitation therapy over the internet~     to improve upper limb function for stroke patients. Home rehabilitation for stroke patients~     will avoid the burden of arrival to the health facilities, making it easier on them and~     improve their quality of life and the lives of their caregivers. To achieve this goal the~     investigators will examine the effectiveness and feasibility of home rehabilitation system~     of upper limb, consisting of ergonomic accessories (hand and arm tutors).~      The quantitative indices will be based on the quantitative clinical measures that are used~     in regular evaluations of stroke patients and function and range of motion indices as~     received from the system.~   "
103918|NCT01696851|"~     People with Spinal cord injury with tetraplegia suffer from respiratory problem due to~     weakness of the muscles and because the autonomic system dysfunction.~      Exercise is one way of preserving and improving physical fitness and directly and indirectly~     reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects~     with spinal cord injury with tetraplegia have limited options for exercise: table tennis,~     gym, pool and more. Because of the nature of the injury which includes the sympathetic~     failure, they can not easily get the desired pulse to improve physical fitness.~      Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could~     not participate in wheelchair basketball. The game combines short, quick races with~     different aerobic capabilities. Previous studies have shown that participants in wheelchair~     rugby Improve anaerobic power, oxygen consumption, physical fitness and daily functioning.~     Wheelchair rugby improves self-confidence and as a result it affects other areas of life.~     Another study examined sense of self-efficacy, saw improvement in this index for rugby~     players in a wheelchair at high levels.~      In the present study the investigators aim to examine whether regular participation in~     wheelchair Rugby for a season has more impact than other routine exercise (table tennis,~     gym, swimming).~   "
103919|NCT01696838|"~     The purpose of this study is to determine whether acupuncture or moxibustion therapies are~     effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate~     the efficacy by functional magnetic resonance imaging.~   "
103920|NCT01696825|"~     The purpose of this study is to determine which of three delivery systems of vaginal~     diazepam have the best systemic absorption, measured by serum diazepam levels. The three~     delivery systems are: moistened tablet, suppository or cream. Additionally the study will~     compare the side effects and absorption of vaginal diazepam with oral diazepam. Vaginal~     diazepam is used off-label vaginally to relax pelvic floor muscles and reduce pelvic pain~     caused from pelvic floor dysfunction.~   "
103921|NCT01696812|"~     The objectives of this study are (1) to compare the clinical outcome in correlation with the~     electrode positions estimated by web-based image fusion of the preoperative MRI and the~     postoperative brain CT taken at a stable period after surgery using mutual information~     technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and~     (2) to examine whether the documentation of the electrode position by using mutual~     information technique at a stable period after unilateral or bilateral STN stimulation~     provides useful information for the postoperative programming.~   "
103922|NCT01696799|"~     To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in~     subjects with interdigital tinea pedis aged 12 years to less than 18 years.~   "
103923|NCT01696786|"~     The specific aim of this study is to further develop methods of oocyte cryopreservation and~     evaluate their impact on reproductive outcomes.~   "
103957|NCT01696344|"~     This prospective study aims to investigate if termination of atrial fibrillation (AF) after~     pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in~     long-standing persistent (LSP) AF, is enough to ensure long-term success.~   "
104252|NCT01692496|"~     Soft tissue and bone sarcomas are rare malignant tumors, which encompasses a large family of~     more than 50 histologically distinct tumor subtypes, all of which share a putative~     mesenchymal origin. In the case of soft tissue sarcomas (STS) surgical excision is the~     mainstay of treatment, but despite curative surgery, around half of patients develop distant~     metastases and die from disease. Few therapeutic approaches are currently available to~     patients with unresectable, locally advanced, or metastatic STS and only anthracyclines,~     ifosfamide and trabectedin have shown activity, with response rates of 20-40% in previously~     untreated patients. Recent and ongoing trials have investigated a variety of combination~     chemotherapeutic regimens (variously employing ifosfamide, doxorubicin, gemcitabine,~     temozolomide, vincristine, cisplatin, and dacarbazine, among others) as well as targeted~     therapies, which in some cases have yielded improvements in response rate but which have had~     little impact on survival. No other medical option is currently available, and the median~     survival of patients with soft-tissue sarcoma with non-resectable metastases is around 12-15~     months, and approximately 8 months after second line chemotherapy.~      Liposarcomas are STS which account for at least 20% of all STS in adults. They can be~     further classified into 3 histologically and biologically different subtypes:~     well-differentiated liposarcoma/dedifferentiated liposarcoma (ALT-WD), myxoid or round cell~     liposarcoma and pleomorphic liposarcoma.~      ALT-WD liposarcomas are locally aggressive rarely metastasizing tumors characterized by ring~     or giant marker chromosomes on the cytogenetic analysis and by amplification of the 12q13-21~     region on FISH (MDM2, CDK4 and HMGIC). They account for about 40% iv of liposarcomas with a~     5 year OS around 80%. In a series of WD/DD treated with several regimens response rate was~     12.5% OS 15 months and median PFS 3.6 months(95 CI: 3.3-5.9) Mixoid /round cell liposarcoma~     accounts for 45-50% of all liposarcomas. They tend to metastasize to unusual soft tissue and~     bone locations. High histologic grade with more than 5% of round cell component is~     associated with a 5-year OS of 50% approximately. They are characterized by~     t(23;16)(q13-14;p11) which leads to the fusion of CHOP and TLS genes Pleomorphic liposarcoma~     accounts for approximately 5-10% of all liposarcomas, characterized by high grade features~     with frequent and early lung metastasis and cytogenetically by high chromosome counts and~     complex structural rearrangements.~      VEGF is expressed in many STS in which increased expression is associated with higher grade~     and worse prognosis.~      Pazopanib is an oral angiogenesis inhibitor that targets mainly VEGFR, PDGFR and c-kit.~     Recently the results of a phase II trial of pazopanib in STS have been published. It was a~     four-cohort 2-stages study. The liposarcoma stratum was closed after the first stage because~     of a PFS at 12 weeks of 17% (3 out of 17 patients did not progressed after 12 weeks). After~     central pathologic review, 2 other patients initially classified as other STS were found to~     have liposarcoma with stable disease at 12 weeks (5/19: 26% PFS12w), thus fulfilling~     criteria for cohort expansion. Phase II study had been completed and in phase III study~     patients with liposarcomas were excluded so therefore data on the liposarcoma cohort are~     inconclusive.~      Furthermore the positive results of the phase III study PALETTE have been recently~     communicated, encouraging this treatment in other sarcomas: progression-free survival (PFS)~     per independent review was significantly prolonged with pazopanib (median: 4.6 vs 1.5~     months; HR=0.31, 95% CI 0.24-0.40; P<0.0001). The interim analysis for overall survival~     shows a statistically non-significant improvement of pazopanib vs placebo (median: 11.9 vs~     10.4 months, HR=0.83, 95% CI 0.62-1.09).~      Soluble factors associated with efficacy and toxicity of pazopanib in these patients had~     been also reported. Decreases in VEGFR2 and increase in PlGF were both associated with~     toxicity (HTA and TSH elevation) and poorer prognosis.~   "
103925|NCT01696760|"~     This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and~     pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic~     compression devices in preventing deep vein thrombosis in patients with pelvic and lower~     extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also~     known as sequential compression devices and are inflatable compression sleeves that are~     placed around patient's legs to reduce the risk of clot formation deep vein thrombosis.~     Pneumatic compression devices are made of a soft material that wraps around the lower leg~     and periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized~     patients wear these as a preventive measure. Pneumatic compression devices alone are not~     sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin~     and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in~     patients with musculoskeletal tumors which have determined whether one drug is better than~     another. The knowledge gained from this study will determine whether aspirin and pneumatic~     compression devices is the same or better than enoxaparin and pneumatic compression devices~     in preventing deep vein thrombosis in this patient population and may result in fewer wound~     and bleeding complications~   "
103926|NCT01696747|"~     To expand a registry of patients for the study of the epidemiology, etiology, and degree of~     morbidity associated with gastroparesis.~   "
103927|NCT01696734|"~     The goal of this clinical research study is to learn if domperidone can help to control~     chronic GI disorders. The safety of this drug will also be studied.~      Domperidone is designed to stimulate contraction of the stomach to increase its ability to~     empty itself of the food.~   "
103928|NCT01696721|"~     In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better~     results in treating patients with cancer, both because there is better control of where in~     the body the radiation is directed and because it is associated with less severe long term~     side effects. However, there is limited published data demonstrating these results. The goal~     of the Pediatric Proton Consortium Registry (PPCR) is to enroll children treated with proton~     radiation in the United States in order to describe the population that currently receives~     protons and better evaluate its benefits over other therapies. The data collected from this~     study will help facilitate research on proton beam radiation therapy and allow for~     collaborative research. The PPCR will collect demographic and clinical data that many~     centers that deliver proton radiation therapy already collect in routine operations.~   "
103929|NCT01696708|"~     The purpose of this project is to study brain energy profile evolution at different stages~     of the Huntington disease.~   "
103930|NCT01696695|"~     This observational study will evaluate the efficacy and safety of different capecitabine~     based chemotherapies, alone or in combination with other therapies, as first line treatment~     of metastatic colorectal cancer in participants during everyday clinical practice.~   "
103931|NCT01696682|"~     The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize~     anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this~     random-controlled research, and investigate the leakage ratio from different widths of~     gastric conduit formed during the operation.~   "
103932|NCT01696669|"~     Tumors of the Ewing sarcoma family (ES) affect children, adolescents and young adults. The~     reported incidence is 0.6 cases per million inhabitants every year. The peak incidence~     occurs between 10 and 20 years and it is rarely diagnosed beyond 30. The ES is a severe~     disease with a progression-free survival after 5 years of 60% in cases without metastasis~     and deadly in the majority of patients presenting metastasis. The ES is considered a~     systemic disease because, despite receiving an adequate local treatment, over 90% of~     patients deaths occur due to disseminated disease. Combined therapy of surgery, radiotherapy~     and chemotherapy has led to an improvement in the prognosis, achieving a survival of about~     60% in most series~      The MSKCC P6 protocol was developed for the treatment of high risk ES. In 2003, Kolb et al.~     reported the MSKCC experience after a 4-years follow-up of 68 patients who had been included~     from 1990 to 2001. Following the MSKCC P6 protocol, a survival rate of 82% was achieved in~     patients without metastasis, superior to the achieved with less intensive protocols.~     Following the guidelines of the MSKCC P6 protocol, in 2002 we modified the treatment~     schedule to create the modified P6 protocol (MP6). GEIS intends to develop MP6 as a clinical~     trial, which could provide the following potential advantages about current treatments:~        1. Lower total dose of alkylating agents.~        2. Early cardioprotection with dexrazoxane.~        3. Radiotherapy adjusted to the initial response.~        4. Pilot trial with the combination of Gemcitabine + Docetaxel for high-risk patients.~   "
103933|NCT01696656|"~     Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with~     significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition~     as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and~     symptom-relieving agents may be required. Prescriptional pattern of these drugs will be~     analyzed in a clinical cohort.~   "
103934|NCT01696643|"~     The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945~     for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for~     chronic non-cancer pain.~   "
103935|NCT01696630|"~     This is a monocentric study in 2 steps: A safety part to assess the feasibility of using~     Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment~     of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly~     allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be~     enrolled and followed over 45 days.~   "
103936|NCT01696617|"~     The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole~     of standard antidepressants would be associated with improved depression response in Major~     depressive disorder, especially in Quality of life.~      The investigators compare the mean changes in the quality of life between before add-on and~     8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of~     aripiprazole.~   "
103958|NCT01696331|"~     Text message reminders will improve adherence to lab tests in adolescent liver transplant~     recipients.~   "
103959|NCT01696318|"~     Develop and evaluate a model of organization and management in the management of patients~     with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity,~     physical inactivity, dyslipidemia and family history) in primary care aimed at the~     compliance, control and treatment effectiveness.~   "
103937|NCT01696604|"~     This study is the first administration of GSK2849466 in humans. This will be a single~     centre, randomized, double-blind, placebo-controlled study, to investigate the safety,~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as~     single and repeat oral doses up to 14 days to healthy male subjects. Part A will be a~     randomized placebo controlled and 4-way crossover study. It will include two cohorts of 8~     subjects each. In each cohort there will be 4 study periods each approximately of 1 week~     including 6 days of washout. Each subject will receive a total of 3 active doses as~     ascending single oral dose of GSK2849466 and 1 placebo dose during the course of their~     participation in the study. The first (bridging dose) dose provided to subjects in Cohort~     2 will be the same as the last dose provided to subjects in Cohort 1. The single doses of~     GSK2849466 planned in Part A of this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in~     Cohort 1 and 0.3, 1, 3, and 10 mg in Cohort 2. In cohorts 1 and 2 all available safety,~     tolerability, and PK data will be reviewed prior to each dose escalation. The dosing~     schedule in Part A may be adjusted to expand a cohort or to add an additional cohort(s) in~     order to further evaluate additional doses or repeat evaluation of a dose level already~     studied. Part B will be a randomized placebo controlled, parallel group study. It will~     include three cohorts of 12 subjects each. Each subject will receive repeat doses of~     GSK2849466 over 14 days. The doses chosen for Part B will be based on the safety,~     tolerability, and PK data from Part A. Subjects in Cohort 4 (and/or an another cohort [s] as~     determined based on Part A PK data) will be dosed in the fasted state on Days 1 and 14 and~     in the fed state on Day 7 when subjects will receive a standard meal 30 minutes prior to~     dosing. Part B will provide sufficient safety and tolerability data to bridge to longer~     duration studies. The study duration, including screening and follow-up, is not expected to~     exceed 70 days for subjects in the study.~   "
103938|NCT01696591|"~     The purpose of the study is to determine the long-term safety and exploratory efficacy of~     NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the~     Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I.~     Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects~     with comparable demographics and disease characteristics as the treatment group will be~     enrolled into a control group, followed-up for 3 months, and compared for various disease~     progression indicators with the treatment group.~      The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of~     the Alzheimer's type.~   "
103939|NCT01696578|"~     This study will measure the effects of biofeedback supported cognitive behavioral therapy~     (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in~     Kosovo. The investigators aim to restore physical and psychosocial functioning of the~     victims of torture and massive violence with available rehabilitation practice and integrate~     them into the community. It is also our objective to build local knowledge and expertise to~     apply measurement principles and CBT methods in the Balkan region.~   "
103940|NCT01696565|"~     The objectives of this Phase I/II study are:~        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced~          malignancy receiving chemotherapy and to define a Study Dose for Phase II.~        2. To evaluate the hematopoietic and immunological responses after administering of PG2.~          Primarily to study the biological response of PG2, defined as WBC count in this study,~          and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.~   "
103941|NCT01696552|"~     A Prospective, randomized, clinical controlled study comparing conventional knee~     arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care,~     Materialise) using the Vanguard Total Knee System (Biomet)~   "
103942|NCT01696539|"~     The purpose of this study is to determine whether sustainable daily physical activity is~     effective in improving biological indicators of health and self-reported quality of life in~     men with prostate cancer.~   "
103943|NCT01696526|"~     The aim of this study is to investigate the bioavailability of conventional and vitamin D~     fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.~   "
103944|NCT01696513|"~     The primary objective of this study is to determine whether the use of standard treatment in~     conjunction with suction will improve acne scars compared to a standard treatment alone.~   "
103945|NCT01696500|"~     Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were~     confirmed based on the investigators national diagnostic criteria. Patients who meet all~     inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01~     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy~     of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be~     evaluated the disease evaluation score et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by 20 days after the start of the study treatment.~   "
103946|NCT01696487|"~     The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),~     cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and~     treatment options are limited. Fructose overconsumption has been associated with gut~     permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced~     intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment~     of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers~     of intestinal damage, inflammation, iron/copper homeostasis and histological/molecular~     analysis of intestinal biopsies. Findings in volunteers will be compared with liver patients~     undergoing study procedures without fructose challenge. Translational in vitro experiments~     will explore cellular responses to fructose and endotoxin. This project should provide novel~     insights into dietary induced alterations of the gut integrity in progression of NAFLD to~     NASH.~   "
103947|NCT01696474|"~     This multicenter, phase II, open label study will enroll patients with chronic cold~     agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm~     iv on days 1, 4, 8, 11.~   "
103948|NCT01696461|"~     This is a Phase II, open-label, two strata, multicenter, prospective study of~     plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological~     malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor~     for this purpose.~   "
103960|NCT01696305|"~     This study is a randomized, double-blind, active controlled phase 3 trial in the patients~     with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the~     patient with the past history of thyroid surgery).~      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)~     or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in~     detecting esophageal dysmotility at 6 weeks after study intervention and will be followed~     for 12weeks.~      During the study, both the patients and the observer for the primary and secondary efficacy~     evaluation will be masked.~      Non-inferiority of the test device (Hyalobarrier) compared to the reference device~     (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal~     esophageal transit.~   "
103961|NCT01696292|"~     This study aims to shed light on the theoretical concept of mental flexibility and its~     manifestation in adolescents following frontal lobe damage, and to develop a test battery~     for young Hebrew speakers.~   "
103949|NCT01696448|"~     Though medical treatment has been effective in the treatment of cardiometabolic diseases~     (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders~     continues to be high. Many reasons are responsible, but lifestyle changes, including an~     increased prevalence of obesity and the metabolic syndrome, are significant for this cause.~     Diagnosis and treatment of obese patients with hypertension requires that health care~     providers address the issues of hypertension, glucose intolerance, body weight and~     dyslipidemia. A sedentary lifestyle and poor cardiorespiratory fitness are not only~     associated with the (cardio) metabolic syndrome but could actually be considered features of~     the metabolic syndrome. These issues are significant in the health of certain individuals,~     who experience greater difficulty in treated BP control, experience increased hypertensive~     and diabetic complications, and have higher levels of obesity.~      In this study, the investigators will evaluate the efficacy of the nutritional supplements~     berberine, alpha-lipoic acid, and picrorhiza (CAR-191) when consumed 30 minutes before~     meals, on appetite suppression, body composition and weight control. Additionally, the~     investigators will evaluate the effects of this combination of nutraceuticals on the~     mechanistic effects of oxidation, inflammation, and vascular function in a high-risk~     population with the metabolic syndrome.~      Primary Objective To assess the comparative effect of a combination (known as CAR-191) of~     berberine (200 mg), alpha-lipoic acid (150 mg), and picrorhiza (100 mg) three times a day,~     compared to placebo three times a day, on parameters relate to appetite suppression, weight~     control and body composition in a high risk population with the metabolic syndrome.~      Secondary Co-objectives~      To evaluate the effects of CAR-191 versus placebo on changes in:~        -  Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound~        -  Biomarkers including IL-6, HOMA-IR, HbA1C, hsCRP, adiponectin, plasma/urine~          isoprostanes, PAI-1, TNFα-II, aldosterone, and glutathione redox ratio~        -  Urinary protein excretion~        -  Clinical chemistry including plasma glucose, blood urea nitrogen, creatinine, total~          bilirubin, uric acid, transaminases (SGOT/AST, SGPT/ALT), alkaline phosphatase,~          C-reactive protein, and lipoproteins~   "
103950|NCT01696435|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and~     will examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome,~     2) yields better mood scores over time, compared to placebo.~   "
103951|NCT01696422|"~     This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical~     trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized~     dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao~     Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited~     and divided into two steps: Step A (with no previous exposure to dengue) and Step B (with~     and without previous exposure to dengue). In step A the participants will be assigned to~     receive either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced~     and formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B~     participants will be assigned to receive either the lyophilized vaccine, or the placebo.~     Both vaccine formulations (lyophilized and liquid) are composed of the same attenuated~     viruses: rDEN1∆30, rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20~     volunteers will have received the liquid formulation (NIH), 210 the lyophilized formulation~     (Butantan), and 70 will have received the placebo. All participants included in both steps~     will be followed by a period of five years after their inclusion in the study. The study~     hypothesis is that the investigational lyophilized dengue vaccine manufactured by Butantan~     Institute is safe and confers balanced immune response, after one dose of 1000PFU, to all~     for vaccine viruses.~   "
103952|NCT01696409|"~     Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in~     adults in the United States. Vitamin D deficiency has been connected to many chronic health~     diseases. The goal of this innovative research is to identify how vitamin D is able to have~     such wide ranging health benefits. This study will determine which genes are turned on and~     turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3~     per day. Results should provide important new insights about the health benefits of vitamin~     D for adults.~   "
103953|NCT01696396|"~     This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study~     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of~     subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all~     screening assessments and meeting all eligibility criteria, subjects will be randomized to~     receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of~     subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the~     double blind period, subjects will enter an open-label period during which all subjects will~     receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail~     to achieve minimal improvement, or experience disease worsening after initial response are~     eligible to enter the open-label period early beginning at week 12 or after. Subjects that~     complete the open-label period or early terminate from the study will enter the 2 year~     safety follow up period.~   "
103954|NCT01696383|"~     The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost~     0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in~     Russian glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular~     pressure (IOP) is uncontrolled while on their current treatment.~   "
103955|NCT01696370|"~     Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes~     breathlessness, chest pain and fatigue. There are few treatments available. The~     investigators have recently shown that a drug called perhexiline reduced symptoms and~     improved exercise capacity in patients with HCM. This change appears to be driven by~     alterations in myocardial energy metabolism. The aim of this trial is to test a similar~     drug, trimetazidine, in a group of symptomatic patients with non-obstructive HCM.~      HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function~     and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.~   "
103956|NCT01696357|"~     This study will examine an innovative strategy to monitor asthma symptoms by using existing~     technology to develop a non-invasive device for monitoring asthma symptoms in adolescents.~     Using an iPod as a platform, and current sound data analysis techniques, a prototype device~     will be developed that will directly monitor the chosen parameters of asthma symptoms,~     including wheezing, coughing and activity levels. This small non-invasive device will be~     continuously carried by or placed in close proximity to the adolescent on a daily basis. It~     is hypothesized that such a device would be acceptable to adolescents and would lend~     accuracy and objectivity to symptom assessment; something that existing monitoring~     strategies have yet to achieve. It will also stimulate the adolescents' partnership in~     asthma self-monitoring and ultimately lead to effective asthma management.~   "
103964|NCT01696253|"~     Over the past 30 years much has been learned about the molecular genetics and natural~     history of familial forms of hematuria. However, enhanced understanding of these conditions~     has yet to generate effective therapies for Alport syndrome(AS), the form of familial~     hematuria associated with end-stage renal disease. Males with AS inevitably develop~     end-stage kidney failure, with a 50% likelihood of dialysis or kidney transplantation by age~     25 years. There is no proven treatment for AS, although studies in animals have suggested~     several promising potential therapies. Pharmacological or biological treatments that might~     delay or prevent the development of kidney failure exist, but need to be evaluated through~     clinical trials. Researchers interested in implementing clinical trials in AS will face~     several challenges, the foremost of which is the relative rarity of the disease,~     necessitating aggressive efforts to identify and recruit potential subjects for multi-center~     collaborative clinical trials. The Alport Syndrome Research Collaborative (ARC) was~     established in 2009 as a partnership of the Alport Syndrome Treatments and Outcomes Registry~     (ASTOR), the European Alport Registry and centers of AS research in Canada, China and France~     with the objective of testing potential treatments to delay or prevent terminal renal~     failure in people with AS. In this feasibility study the five ARC centers will interrogate~     existing AS registries and databases, and monitor accrual of new AS cases over an 18-month~     period, in order to quantify subjects in the disease categories of interest. As part of this~     project we will examine the utility of urinary uromodulin excretion as a marker of kidney~     injury and potential trial endpoint in AS clinical trials. Our goals are to (1) demonstrate~     that participating centers have access to sufficient numbers of males and females with AS to~     populate adequately-powered clinical trials focused on two clinical targets,~     microalbuminuria and overt proteinuria, and (2) to test the hypothesis that in males with AS~     urinary uromodulin excretion decreases as albuminuria and proteinuria increase and that~     uromodulin offers an independent and insightful measure of renal fibrosis and response to~     therapy.~   "
103965|NCT01696240|"~     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5~     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with~     mild pulmonary hypertension.~   "
103966|NCT01696227|"~     Background:~      Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children.~     Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure,~     pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has~     not shown improvement of the risk of these diseases, and contributes to the growing public~     health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the~     bowel. In an effort to reduce the number of UTIs, investigators want to exchange the~     bacteria living in our bowels for a more harmless variety.~      Hypothesis and specific aims:~      Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the~     bowel bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing~     frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary~     tract problems that require use of catheters to empty their bladders.~      Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species,~     Enterococcus species, and Klebsiella species to live in the same environment with the~     probiotic bacteria to see how the numbers of each bacteria change.~      Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge~     them to live in the same environment as the probiotic bacteria.~      Potential Impact:~      This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless~     bacteria and reduces the use of antibiotics overall in the community.~   "
103967|NCT01696214|"~     The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of~     implementing the provisional design of the full scale TOM trial (e.g., the six month~     treatment period, the impact of the smoking cessation intervention).~      There is no active hypothesis for the Vanguard Protocol.~   "
103968|NCT01696201|"~     Due to physical and physiological changes that occur in pregnant women, depression is very~     common during this period. Recent research findings indicate that antenatal maternal mood~     state impacts on babies health. Nowadays, many researchers are focussed on examining the~     effects of physical exercise on foetal and maternal outcomes.~      The main aim of this study was to assess the effectiveness of a supervised exercise program~     consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises~     (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the~     prevention and treatment of depression in pregnant women. Additionally, the other purpose of~     the study was to analyze the effects of depression and physical exercise on outcomes.~      Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a~     better mood state than pregnant women who are sedentary, without having any negative effect~     on outcomes.~   "
103969|NCT01696188|"~     This is a randomized, double-blinded, prospective study designed to compare two approaches~     (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing~     an interscalene nerve block and catheter for pain control after open shoulder surgery. Both~     approaches have been used successfully but neither has been proven to be superior. Our~     endpoints are pain scores, time for block placement, and catheter dislodgements. We~     hypothesized that patients with the out-of-plane approach would have decreased pain and~     fewer catheter dislodgements.~   "
103970|NCT01696175|"~     Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for~     lactate levels and ScvO2. Children instrumented with arterial and central venous catheters~     are included within the first 12 hours after admittance.~   "
103971|NCT01696162|"~     This is a clinical research trial to evaluate the efficacy of delivering exercise therapy~     for knee pain via the Internet utilizing an algorithm designed to adjust a home exercise~     program based on user input. The investigators hypothesize that exercise therapy can be~     delivered safely and effectively with increased participant satisfaction compared to the~     current standard.~   "
103972|NCT01696149|"~     The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous~     electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic~     skin response (SSR) and skin temperature.~   "
103973|NCT01696136|"~     The MYSTIC_PAF trial investigates the differences between treatment with a single-tip~     catheter against a multielectrode catheter in cardiac ablation procedures in patients with~     paroxysmal atrial fibrillation.~   "
103974|NCT01696123|"~     Current therapeutic approaches for the treatment of neurodegenerative diseases like~     Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients~     but do not mitigate the insidious loss of neuronal cells. In this trial the investigators~     will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild~     to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from~     Treatment with Rivastigmine.~   "
104253|NCT01692483|"~     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in~     male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC)~     who have received prior chemotherapy containing a taxane.~   "
103975|NCT01696110|"~     The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three~     antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or~     unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.~      All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of~     the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.~   "
103976|NCT01696097|"~     The purpose of this study is to determine if the source of dietary protein (pork or~     chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high~     blood pressure.~   "
103977|NCT01696084|"~     To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients~     (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint~     will be overall survival.~   "
103978|NCT01696071|"~     Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks~     treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg~     tiotropium administered twice daily (morning and evening). In addition compare the 24 hours~     pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium~     administered twice daily in pharmacokinetic sub-investigation.~   "
103979|NCT01696058|"~     The overall objective of this study is to assess efficacy and safety of 12 weeks, once~     daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat®~     Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to~     tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.~   "
103980|NCT01696045|"~     The purpose of the study is to comply with the Pediatric Investigation Plan requirements of~     Ipilimumab~   "
103981|NCT01696032|"~     A 2-part, Phase 1-2 controlled, open-label, randomized study in patients with~     platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and~     carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In~     Part 2, patients will be randomized to receive the dose identified in Part 1 plus~     carboplatin or one of three treatment of choice at the discretion of the investigator. The~     treatment of choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.~   "
103982|NCT01696019|"~     A pilot randomized clinical trial was conducted in a random sample of 120 non-demented~     Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the~     effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no~     intervention with respect to change in cognition and whole brain volume determined by~     repeated neuropsychological batteries and MRI scans. Aims included determining the~     feasibility of recruiting and retaining a random sample of people age 60+ for such a trial~     as well as collection of preliminary data on the efficacy of the interventions. The~     long-term goal of this research program is to determine whether sustained physical and/or~     mental exercise interventions are efficacious in delaying the onset of dementia and to~     understand the role and mechanisms of brain growth in this process.~   "
103983|NCT01696006|"~     The purpose of this study is to determine whether coronary perfusion computed tomography is~     effective in the treatment of coronary artery disease.~   "
103984|NCT01695993|"~     216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who~     expect to have nausea, will be entered. Participants will be randomized to one of three~     study arms: Arm 1: Version 1 handout; Arm 2: Version 1 handout + Version 1 relaxation MP3 +~     acupressure bands; Arm 3: Version 2 handout + Version 2 relaxation MP3 + acupressure bands.~      Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in~     controlling chemotherapy-induced nausea~   "
103985|NCT01695980|"~     The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with~     modified retractor is used compared to use of an endotracheal tube (ETT) and non modified~     retractor is used.~   "
103986|NCT01695967|"~     patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method~     to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and~     tonsillectomy. It will compare the amount of nasal congestion for each group with the idea~     that it will be less if treated with turbinate cauterization. Assessments from baseline to 6~     months post procedure will be compared between the two groups.~   "
103987|NCT01695954|"~     The main goal of this study is to determine how taking efavirenz affects the levels of~     pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir~     with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to~     see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are~     taken together and to see how taking pitavastatin affects the levels in the blood of~     darunavir.~   "
103988|NCT01695941|"~     This phase I trial studies the side effects and best dose of alisertib and bortezomib when~     given together with rituximab in treating patients with mantle cell lymphoma or B-cell low~     grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or~     does not respond to treatment (refractory). Alisertib and bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving~     alisertib and bortezomib together with rituximab may be a better treatment for relapsed or~     refractory mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma.~   "
103989|NCT01695928|"~     The low-energy extracorporal shockwave is a scientifically approved method to activate~     respectively increase bone-turnover processes especially in orthopedic medicine. The aim of~     this clinical study is to apply this effect in orthodontic dentistry and evaluate the~     orthodontic tooth movement respectively miniscrew stability clinically.~      This randomized clinical study is carried out in orthodontic patients undergoing space~     closure therapy at the university clinic of dentistry. During this period the tooth movement~     rate as well as the miniscrew stability are evaluated consecutively chairside.~   "
103990|NCT01695915|"~     The purpose of the study is to determine the diurnal variation of rectal diameter in healthy~     and constipated children using transabdominal ultrasound.~   "
104056|NCT01695057|"~     This pilot clinical trial studies vorinostat before surgery in treating patients with~     triple-negative breast cancer. Vorinostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving enzyme inhibitor therapy before surgery~     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed~   "
103991|NCT01695902|"~     The primary objective of this study was to compare the efficacy of Test Product (Levosert)~     vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual~     blood loss volume in women with menorrhagia.~      The secondary objectives includes physical and gynaecological examinations, vital signs,~     clinical laboratory tests including hemoglobin and ferritin measurements, body weight and~     spontaneously reported adverse events were analysed and compared between Levosert and~     Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after~     various periods of time. The residual amounts of LNG in the devices were finally measured~     after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of~     LNG were compared between the two treatment groups. Contraceptive effect of Levosert was~     estimated by Pearl Index.~   "
103992|NCT01695889|"~     The purpose of this study is to compare exposure to general anesthesia between cases with a~     diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical~     records. The investigators wish to explore if there is a relationship between exposure to~     general anesthesia and the development of Alzheimer´s disease.~   "
103993|NCT01695876|"~     Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy~     subjects~   "
103994|NCT01695863|"~     This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade~     versus Movi Prep for outpatient colonoscopy.~   "
103995|NCT01695850|"~     The objective of this study is to evaluate the efficacy and safety of a Chinese herbal~     proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western~     medicine (WM), senna, and placebo for patients with functional constipation (FC) in~     excessive TCM syndrome.~   "
103996|NCT01695837|"~     The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity~     dietary counseling intervention provided by the primary care physician (PCP), in patients at~     risk for cardiovascular diseases~   "
103997|NCT01695824|"~     The primary objective of this study is to assess combined end point (All stroke, Systemic~     embolism, Cardiovascular death) between two groups.~   "
103998|NCT01695811|"~     The purpose of this study will be to determine optimal surgical technique for performing~     FLAK including laser parameters, keratoplasty shape and suture technique in order to~     standardize surgical technique and to collect safety and efficacy data. This will be~     compared to data of patients with full thickness PKP to measure visual outcomes, refraction,~     astigmatism, surgical methods and wound healing.~   "
103999|NCT01695798|"~     Chronic malnutrition is associated with lack of effective gut immunity which is a possible~     explanation for why we see polio cases among a proportion of children who have received 7 or~     more doses of OPV.Our proposed idea is to evaluate if IPV antigen given later in life may~     act together to boost humoral and mucosal immunity in children belonging to low-income~     background in Karachi who have moderate to severe chronic malnutrition (height for age Z~     score less than -2SD). We also intend to compare eIPV + OPV with OPV only in~     non-malnourished infants at 9 -12 month of age. Thus, the proposed study is a combination of~     two trials, with study population stratified by nutritional status, each with a reference~     arm (bOPV) and an experimental arm (bOPV plus IPV).~   "
104000|NCT01695785|"~     Little is known regarding the relationship between perceived and physiological exertion in~     adolescents. The purpose of this study is to investigate the association between~     physiological and perceptual markers of effort during exercise and the relationship of these~     markers to other health-related behaviors in healthy weight and obese adolescents.~   "
104001|NCT01695772|"~     This open-label, single arm, multicenter study will evaluate the resection rate in~     participants with colorectal cancer and previously untreated unresectable liver-only~     metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant~     setting. Participants will receive standard 5-FU based chemotherapy plus Avastin bevacizumab~     5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and~     postoperatively unless they experience progressive disease or unacceptable toxicity.~   "
104002|NCT01695759|"~     To evaluate the clinical efficacy and immunogenicity of the drug test Eritromax ® - (rHuEPO~     Blau) compared to drug Eprex ® (Janssen-Cilag rHuEPO) in the treatment of patients who have~     anemia secondary to chronic kidney disease (CKD), during the correction through assessing~     the change in hemoglobin levels.~   "
104003|NCT01695746|"~     This observational study will evaluate the use in clinical practice and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients~     not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible~     patients will be followed for 24 weeks.~   "
104004|NCT01695733|"~     This clinical trial studies the best time to administer the influenza vaccine to patients~     with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different~     times relative to chemotherapy may affect how well it works to help the body build an immune~     response and prevent influenza in these patients.~   "
104005|NCT01695720|"~     The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for~     pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage~     injuries). The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.~      The hypothesis is the VisionScope Imaging system will be able to provide direct~     visualization and diagnostic images of inside the joint capsule space without fluid~     distention in the knee. This study will provide valuable feedback on the ability of the~     VisionScope system to provide physicians with the information they need to make a definitive~     diagnosis.~   "
104006|NCT01695707|"~     Many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier~     as demonstrated by high water loss. In laboratory conditions, studies have shown that~     pioglitazone restores the skin barrier function in skin from eczema patients. The purpose of~     this study is to determine if taking pioglitazone improves the skin barrier function in~     people with eczema.~   "
104007|NCT01695694|"~     The purpose of the study is to test the feasibility, acceptability, and efficacy of an~     adapted intervention that is theoretically and empirically guided by the~     Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk~     behavior among women who have experienced Intimate Partner Violence (IPV), as well as such~     an intervention.~   "
104515|NCT01689077|"~     The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia~     following out of hospital cardiac arrest gives a better cerebral outcome compared to 24~     hours therapeutic hypothermia.~   "
104009|NCT01695668|"~     The purpose of this research is to:~        1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have~          been diagnosed with graft-versus-host disease (GVHD), which is a complication that may~          occur after bone marrow transplant where the newly transplanted material attacks the~          patient's body and may cause eye dryness.~        2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the~          process in GVHD before the patient undergoes bone marrow transplant.~        3. Compare how well Lotemax works in decreasing the process in GVHD with an~          immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of~          this condition.~   "
104010|NCT01695655|"~     Corneal transplantation is the most commonly performed human tissue transplant worldwide.~     Over 40,000 corneal transplants occur in the US each year. .~      This study will determine specific corneal neovascularization (CN) patterns in human corneal~     allograft recipients to determine the characteristics that worsen the prognosis for graft~     survival. We will test the hypothesis that specific characteristics of CN are prognostic for~     corneal allograft rejection.~   "
104011|NCT01695642|"~     Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed~     for correction of myopia. There are very few studies that have been performed to evaluate~     long-term outcomes after LASIK.~      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess~     stability of visual outcomes and long-term effect on corneal morphology with in vivo~     confocal microscopy. Clinical and corneal morphology outcomes will also be compared between~     patients who had flaps created with the microkeratome and femtosecond laser.~   "
104012|NCT01695629|"~     Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal~     evaluation that permits non-invasive imaging of corneal structures on the cellular level.~     Precise anatomic characterization of corneal structures, including corneal nerves, can be~     rapidly performed with high resolution.~   "
104013|NCT01695616|"~     The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone~     combination in relieving the symptoms associated with Climacteric Syndrome.~   "
104014|NCT01695603|"~     Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain~     capnia and oxgen partial pressure within predefined ranges in comparison to the control of~     capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in~     brain injured patients. Comparison of the numbers of alarms and required settings~     modifications observed with each ventilatory mode.~   "
104015|NCT01695590|"~     To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for~     patients with relapsed or relapsed/refractory multiple myeloma.~   "
104016|NCT01695577|"~     The main aim of this study is to evaluate the effect of vestibular rehabilitation and~     balance training on patients with dizziness and balance problems after traumatic brain~     injury.~   "
104017|NCT01695564|"~     Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In~     the last two decades the number of hospitalizations for AF has increased two- to three-fold.~     More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac~     disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a~     stroke compared with those without AF.~      This registry will collection information on two devices that are used to treat AF. The~     WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices~     on outcomes related to AF has not been studied. This study will look to compare the two~     devices to see how the outcomes may vary.~   "
104018|NCT01695551|"~     Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the~     lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal~     electrical pathways located in the heart tissue. A standard procedure called a catheter~     ablation has been used for several years to help correct these abnormal pathways and, in~     some cases, improve or even eliminate the ventricular tachycardia.~      During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate,~     and oxygen saturation in your blood). If you choose to participate in this study we will~     also monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your~     brain during the ablation.~      By doing this study, we hope to have a better understanding of patients' blood and oxygen~     flow to their brain during an episode of Ventricular Tachycardia (VT).~   "
104019|NCT01695538|"~     Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term~     inappropriate in medicine is commonly defined as a heart rate greater than 100 beats per~     minute at rest or with minimal physiological challenge. IST is characterized by an increased~     resting heart rate with an exaggerated response to exercise or stress.~      Yoga has been used extensively around the world as an alternative medicine approach in~     treating numerous chronic and debilitating diseases. Studies have been conducted in various~     countries to determine the benefits of Yoga as therapy for these chronic diseases. Several~     studies have confirmed that yoga can reduce anxiety and regulate the stress response.~      Studies in the past have shown that Yoga relieves stress, one of the most common triggers~     for the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize~     that patients with IST might benefit by practicing yoga. Yoga may also help in better rate~     and rhythm control with yoga when employed in combination with usual medical arrangement.~   "
104020|NCT01695525|"~     Syncope is a common problem that many clinicians may encounter in various outpatient~     settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self~     limited episode of systemic hypotension. Patients are usually managed with education on~     syncope, anxiety management, and coping skills.~      It has been established that practice of Yoga could relieve stress and anxiety. In a~     different study, they also found that Yoga positively influences cardiovascular function by~     decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve~     control over the autonomic nervous system and able to control functions like heart rate,~     blood pressure and respiratory rate.~      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators~     propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms~     associated with these episodes.~   "
104220|NCT01692912|"~     Canadian Rheumatologists will be randomized to treat their participants with active~     Psoriatic Arthritis to a target (disease activity score <2.6), or as per their routine care.~     The aim of this study is to determine whether treating to a target results in greater~     disease improvement than treating patients using routine care.~   "
104021|NCT01695512|"~     The aim of our prospective and multicentre diagnostic study is therefore to elucidate on the~     sensitivity and specificity rates of these serologic markers in combination with molecular~     tools (both an Aspergillus specific and a multifungal PCR based assay), as serologic~     mark-ers are not pathogen-specific, and furthermore to define species-specific cut-off~     values for BDG in BAL samples.~      Additionally, if genomic material of Aspergillus fumigatus is detected by PCR in a clinical~     sample, we investigate fungal DNA for point mutations in the cyp51A gene mediating~     resis-tance against common mould-active triazoles with novel rapid, sensitive and specific,~     non-culture-based PCR-assays and sequencing to optimize antifungal treatment as early as~     pos-sible.~   "
104022|NCT01695499|"~     The aim of this project is therefore to explore on the clinical significance of analyzing~     surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and~     biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR~     assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts~     with pulmonary infiltrates.~      As GM and BDG are not species-specific, three established and repeatedly published species~     specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed~     by our group will be investigated in combination with the serological tests in a multicenter~     prospective clinical diagnostic trial.~   "
104023|NCT01695486|"~     The purpose of this study is to compare sedation monitoring by bispectral index and comfort~     score during open muscle biopsies in children.~   "
104024|NCT01695473|"~     This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer.~     Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the~     prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks~     after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at~     this dose level orally once daily for 14 days prior to radical prostatectomy at University~     of California, San Francisco. Radical prostatectomy will be performed on the day of the last~     dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.~   "
104025|NCT01695460|"~     The trial is primarily designed to investigate whether treatment with vitamin D may~     influence migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D~     may serve as a prophylactic treatment of migraine. The hypothesis is tested by examining the~     changes in the pain and symptom patterns associated with migraine by treatment with Vitamin~     D, by means of quantitative sensory testing, diaries and blood samples for measurement of~     vitamin D. Other pain biomarkers are also measured to evaluate whether the levels of these~     biomarkers in the blood is changed by the treatment with vitamin D. The hypothesis here is~     that levels of those biomarkers will change following the treatment.~   "
104026|NCT01695447|"~     The purpose of this study is to determine whether duct-to-mucosa is better than invagination~     in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open,~     randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula~     (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014,~     until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer,~     peri-ampullar carcinoma or other benign or malignant diseases which need to operate~     pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate,~     mortality, morbidity, reoperation and hospital stay. The investigators assumption that~     duct-to-mucosa is better than invagination.~   "
104027|NCT01695434|"~     To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in~     subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over~     24 months and compared to a reference population of healthy controls.~   "
104028|NCT01695421|"~     Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac~     function for the remainder of their life and consequently require continuous medical~     management and intermittent hospital admissions. Several investigations have demonstrated~     that electrical muscle stimulation (EMS) produces positive physiologic and psychological~     adaptations in patients with HF. However not all the EMS modalities were been evaluated on~     this population or not even were tested based on present recognized gold standard clinical~     parameters after a short period of treatment. The primary aims of the proposed study is to:~     Determine the effect of a five week home based of three EMS modalities on prognostics~     markers, perceived quality of life, muscle force and electrical activity in subjects~     diagnosed with HF.~   "
104029|NCT01695408|"~     Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing~     interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the~     mean survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years.~     As in Europe data are limited on the characteristics and management of such patients,~     INSIGHTS-IPF was initiated as a new registry that documents newly diagnosed (incident) and~     prevalent patients with confirmed IPF diagnosis prospectively.The registry will contribute~     to the optimization of the management of IPF patients in the long term.~   "
104030|NCT01695395|"~     Quality of mental health services provision for adults with intellectual disability and~     comorbid mental disorder is considered inadequate and therefore in need of further~     improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study~     therefore aims to compare mild and moderate intellectual disabled adults with a comorbid~     mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid~     mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,~     epidemiological, cross-sectional study. A representative sample of the target population is~     realised by the assessment of approximately n=600 intellectual disabled adults working at~     specialized facilities (sheltered workshops). A cluster sampling with probability~     proportional to institution and size (n of overall employed persons) will be followed by a~     simple random sampling of persons of these clustered facilities. A number of parameters such~     as severity of mental health impairment, needs for care, quality of life (QoL), caregiver~     burden, health services utilization, and costs for care will be assessed by using a set of~     well-established standardised instruments. Quality of mental health care will be assessed~     and examined by open questions to intellectual disabled adults with a comorbid mental~     disorder as well as informal caregivers and staff of caring institutions.~   "
104734|NCT01686230|"~     This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic~     stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and~     waiting-list. And to confirm the specificity of acupoints on meridian.~   "
104031|NCT01695382|"~     Palliative care is a priority area of focus for health care in an aging population~     experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative~     care, access remains limited, especially in poor urban and rural settings. Cultural and~     linguistic barriers may also increase disparities in palliative care for Latinos. Due to a~     nationwide shortage of palliative care providers and the unique cultural preferences and~     values of patients, the investigators are testing a patient navigator intervention to~     improve palliative care outcomes for Latinos with advanced cancer.~   "
104032|NCT01695369|"~     Evaluation of Comfilcon A and Senofilcon A Lenses~   "
104033|NCT01695356|"~     Melasma is an acquired discoloration of the skin characterized by brown colour changes~     commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The~     control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV~     sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible~     light sunscreen. Visible light has melanotic properties and avoiding it can be part of the~     treatment for melasma patients. The estimated number of subjects to be recruited and~     randomized for the study is at least 25 per group. The purpose of this study is determine if~     there is a difference in the improvement between these two sunscreens types. Melasma Area~     and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks~     4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated.~     Occurrence of adverse effects will also be recorded.~   "
104034|NCT01695343|"~     The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway~     anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway~     infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway~     Pa infection will be safe and well-tolerated, and will increase the time-to-need for~     antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and~     symptoms compared with placebo.~   "
104035|NCT01695330|"~     This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who~     will receive treatment with a SC bortezomib-containing combination regimen that does not~     contain thalidomide or vincristine. The patients will be required to have received a prior~     IV bortezomib containing combination regimen that did not contain thalidomide or vincristine~     and that differs from the SC bortezomib-containing one. In between the time that the patient~     received the IV bortezomib-based combination regimen and enrollment onto this study,~     patients may have received other non-bortezomib-based regimens as long as these treatments~     did not contain thalidomide or vincristine. This study will enroll patients who have~     relapsed or have become refractory to their prior IV-administered bortezomib-containing~     combination regimen as demonstrated by progressive disease while on or following that~     regimen. Patients must have received 4 doses of a minimum of 1.0 mg/m2 of bortezomib~     administered IV in no more than 4 weeks per cycle. Patients must have received at least one~     cycle meeting this definition and have shown progressive disease to be considered eligible.~     Patients who have relapsed or have become refractory to their most recent IV~     bortezomib-containing combination regimen are eligible regardless of when they received that~     regimen, as long as they meet the above criteria.~      The study will consist of a screening period, followed by up to eight open label treatment~     cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a~     follow-up period.~   "
104036|NCT01695317|"~     Traditionally, beta blockers have been used for migraine prophylaxis, but in later years~     also antiepileptic drugs. Contraindications and side effects have to some degree limited~     their use, and new prophylactics that can be used by most migraine sufferers and with little~     side effects are in demand. One product that may seem to fulfill these requirements is~     Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and~     animals. L-carnitine is necessary for fatty-acid metabolism and energy production.~      To our knowledge, no placebo-controlled studies have previously evaluated the efficacy of~     Acetyl-L-carnitine in adults with migraine.~      The aims of the present study is to evaluate the efficacy of Acetyl-L-carnitine as a~     prophylaxis in migraine patients~   "
104037|NCT01695304|"~     The aim of the study is to examine the efficacy of ceramic water filters to reduce the~     burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya~     very young children are given drinking water or water is used in reconstitution of their~     food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking~     water reducing infection in infants.~   "
104038|NCT01695291|"~     This study will examine the feasibility and potential efficacy of augmenting SRIs with~     minocycline. The study will assess whether the addition of minocycline leads to measurable~     changes in striatal glutamate (Glu) levels. This study will recruit 45 youth ages 8-20~     diagnosed with clinically significant OCD who have demonstrated no more than minimal~     response to SRI treatment and are currently on a stable dose of SRI medication for at least~     12 weeks. Participants will be randomized to receive either 12 weeks of minocycline~     treatment or pill placebo. Randomization will be 2:1 so that 2 of 3 participants receive~     minocycline. Screening for eligibility will take place for 1-4 weeks. Participants will~     undergo MRS scans to measure striatal Glu levels prior to randomization, and again~     immediately following the treatment period. During the treatment period, participants will~     meet initially weekly and then every other week with the study psychiatrist. All~     participants will be offered three months of open medication treatment following~     participation. The clinical trial will only be conducted at NYSPI and the MRS scans may be~     conducted at Weill Cornell Medical Center or NYSPI.~   "
104039|NCT01695278|"~     Diabetes poses a substantial burden to racial/ethnic minorities and in populations with~     limited access to healthcare. However, there is a shortage of healthcare providers available~     to help patients adopt the lifestyle changes required for diabetes control. The goal of the~     present study is to evaluate the feasibility and effectiveness of a diabetes self-care~     intervention delivered by medical students to patients with poorly controlled diabetes.~     Training medical students to use proven communication techniques to help patients identify~     and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible~     strategy. The investigators anticipate that findings from our pilot study will be used to~     develop a larger study to definitively test the program's effectiveness. A long-term benefit~     of our program is that future healthcare providers are practicing the skills needed to~     promote positive lifestyle changes and provide care for chronic conditions in diverse~     communities.~   "
104041|NCT01695252|"~     Providing feedback on patient progress to therapists improves clinical outcomes for~     patients, particularly those who are failing to improve with therapy. The encouraging~     research has been carried out by a small group of researchers, largely working in the United~     States health care context. The samples studied have been young people attending university~     counselling services, suffering from mild mental health disorders. The group studies are~     therefore not similar to patients seen for psychological therapy in the NHS. Also given that~     therapists are not necessarily alert to treatment failure, have an overly optimistic view of~     their patients progress even when provided with evidence to the contrary, clinical~     supervision may be a more effective method through which to provide patient informed~     clinical outcomes than directly to therapists themselves.~      We will assess if providing feedback through the supervision process is more effective than~     providing this information to therapists themselves in terms of improving clinical outcomes,~     particularly for patients who are failing to improve with routine NHS Psychological therapy.~   "
104042|NCT01695239|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo~     in participants with active psoriatic arthritis.~   "
104043|NCT01695226|"~     Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is~     evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further~     determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the~     changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor~     celecoxib.~      In a single-centre double-blinded phase II study, breast cancer patients were randomised to~     receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three~     weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical~     excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,~     which allows to study the genome-wide changes at the transcriptional level.~   "
104044|NCT01695213|"~     Thr purpose of this study is to compare the clinical and radiological results, as well as~     the femur bone density measurements of two uncemented total hip prostheses during 5 years of~     follow up.~   "
104045|NCT01695200|"~     This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in~     reducing the severity of autism and its comorbidities.~   "
104046|NCT01695187|"~     This is a study to test the hypothesis that time to healing of a cold sore will be lower in~     the active treatment arm of the study when compared to the vehicle (placebo). Subjects with~     a history of cold sores will be enrolled and administered active treatment or placebo in a~     blinded manner. Subjects will then be followed to assess time to healing.~   "
104047|NCT01695174|"~     In the current protocol, we propose the assessment of potential beneficial effects of the~     antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15~     adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice~     daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or~     equal to 40 kg will receive Xifaxan, 550 mg twice daily.~   "
104048|NCT01695161|"~     The aim of the present study is to compare intraocular pressure (IOP) values assessed with~     Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann~     applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We~     want to investigate biomechanical characteristics of the cornea and their influence on the~     IOP-measurements.~   "
104049|NCT01695148|"~     The purpose of this cluster-randomized trial is to examine whether daily consumption of~     β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and~     improve the vitamin A status and among 4-8 year old children in rural Zambia.~   "
104050|NCT01695135|"~     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when~     co-administered with prednisone in Asian patients with metastatic castration-resistant~     prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.~   "
104051|NCT01695122|"~     The purpose of this study is to evaluate if the addition of valproic acid to standard~     platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck~     squamous cell carcinoma can improve treatment outcomes, such as response rate.~   "
104052|NCT01695109|"~     Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1)~     mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be~     associated with changes in food choices, as suggested by animal studies. It has been shown~     that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity~     research and can be used to study the response of several brain regions to the visual~     presentation of preferred in comparison to non preferred food items and to non food items~     The aim of this study is to search for possible effects of liraglutide in comparison to~     placebo on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy~     volunteers.~      Findings of this study will help not only to get deeper insight into the mechanism of the~     anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In~     the future, it is planned to extend the results of this study in normal weight volunteers to~     obese diabetic subjects.~   "
104053|NCT01695096|"~     To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly~     ongoing pregnancy rate between high humidity incubators and humidity free incubators~   "
104054|NCT01695083|"~     Abstract:~      Fatty liver most frequently corresponds to a fat overload of the liver. It is usually~     classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic~     fatty liver overload, the histological spectrum ranges from simple steatosis to~     steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of~     progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH.~     Screening of these hepatic lesions is difficult especially as they may exist while the liver~     tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes~     them in particular to the risk of hemorrhagic complications.~      Objectives:~      The main objective of the study was to determine in patients with morbid obesity waiting for~     bariatric surgery, the accuracy of non-invasive tests to assess liver steatosis, fibrosis~     and inflammation for the diagnosis of NASH, taking as reference the liver biopsy with a~     morphometric study of these parameters.~      Inclusion criteria:~      Patients with the following criteria will be eligible for the study:~        -  Age ≥ 18 years~        -  BMI ≥ 35 kg/m2~        -  Bariatric surgery scheduled within 3 months following the inclusion~        -  Signature of informed consent~      Non-inclusion criteria:~      Patients with at least one of the following criteria will not be eligible for the study~        -  Patient non-affiliated to a social security scheme (beneficiary or assignee)~        -  Contra-indication for performing an MRI~        -  weight>230 kg; anteroposterior diameter>40 cm~        -  Cancer treatment or medication that may induce lesions of steatohepatitis (corticoids,~          methotrexate, amiodarone, perhexiline, tamoxifen, nifedipine, diltiazem, hycanthone)~        -  Alcohol consumption >20 g per day for women and >30 g per day for men AND no past~          history of excessive alcohol use for more than a 2-year period within the last 20 years~        -  Known chronic liver disease (except for steatosis): presence of HBs antigen, or~          antibody to HCV, or anti-nuclear antibodies, anti-mitochondria, anti-LKM1, anti-smooth~          muscle negative, or the presence of a hemochromatosis,~        -  Known HIV positive status~        -  Pregnant (known pregnancy) or lactating women~      Number of subjects required:~      According to the literature and data collected Louis Mourier in the recent years, the~     inclusion of 200 patients would examine 20-40 patients with severe histological steatosis~     and steatohepatitis. All patients will be included in Louis Mourier hospital.~      Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total~     duration of participation for a patient will be one month.~      Methodology:~      It is a monocentric, prospective study evaluating the value of noninvasive tests for the~     diagnosis of hepatic lesions in morbid obese patients. The open  MRI system allows access~     to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available~     in France and liver pathology can be explored only on the system of Louis Mourier.~      The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP,~     and serum tests.~      Examinations required specifically for research Examinations required specifically for the~     research is abdominal MRI, FibroScan/ CAP and serum tests.~      Primary endpoint :~      To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe~     steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values~     of these tests are calculated. The gold standard is the result of histology on liver biopsy,~     with a morphometric study of these parameters. ROC curves are used to determine the best~     compromise between sensitivity and specificity.~      The secondary endpoints were:~      Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form~     of three variables of interest: quantification of the surface of the visceral fat, of~     subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal~   "
104055|NCT01695070|"~     Intrauterine growth restriction is the term used to describe a condition where an unborn~     baby does not reach its optimum size. In the short and long term, intrauterine growth~     restricted babies have a higher risk of serious disease and even death. It is well~     established that very low levels of oxygen in the baby's blood can harm the baby's health~     through a state known as oxidative stress. Currently, there is no established treatment~     available to treat intrauterine growth restriction or its complications. In experimental~     animal studies however, the naturally occuring hormone, melatonin, has been shown to~     significantly reduce oxidative stress and improve health of the unborn babies that have~     suffered from intrauterine growth restriction. This study aims to find out if the use~     melatonin twice per day throughout pregnancies affected by intrauterine growth restriction~     will lower the level of oxidative stress experienced by the unborn baby. If this is the case~     melatonin may help protect the unborn baby from damage caused by oxidative stress, this will~     be studied in a separate future study.~   "
104057|NCT01695044|"~     PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and~     tolerability of PSMA ADC in two groups of subjects with metastatic castration-resistant~     prostate cancer (mCRPC). One group comprises subjects who must have received at least one~     taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has~     received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for~     study participation. The second group comprises subjects who are cytotoxic~     chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and~     progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to~     Radium-223. Both groups of subjects must also have received and progressed on abiraterone~     acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or~     enzalutamide, Sponsor approval is required for participation in the study. Subjects will~     receive up to eight doses of PSMA ADC approximately once every three weeks.~   "
104058|NCT01695031|"~     The objective of this study is to determine the feasibility of conducting a randomized~     controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated~     asthma management intervention designed to reduce asthma-related morbidity among urban~     teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around~     recruitment, participant compliance with the study protocol, Internet access, and attrition.~     Investigators will first develop a protocol for recruiting 13-19 year old patients with~     acute asthma into an ED-initiated pilot trial of an online asthma management program,~     describing recruitment and refusal rates. Investigators will measure participant compliance~     with the pilot study protocol including 4 online sessions and a 6 month survey.~     Investigators will also measure compliance of the participants parents at baseline and a six~     month follow up. Investigators will then use pilot study results to describe the~     intervention effect on selected outcomes including ED visits, asthma control as measured by~     Asthma Control Questionnaire, functional limitations, quality of life, and behavior change.~   "
104059|NCT01695018|"~     The purpose of this study is to verify the function of p16 methylation diagnostic reagents~     in early diagnosis of oral cancer.~   "
104060|NCT01695005|"~     The purpose of this study is to find a recommended dose level of LY3039478 that can safely~     be taken by participants with advanced cancer or cancer that has spread to other parts of~     the body, including but not limited to lymphoma. The study will also explore changes to~     various markers in blood cells and tissue. Finally, the study will help to document any~     tumor activity this drug may have.~   "
104061|NCT01694992|"~     The purpose of this study is to evaluate the effectiveness of a rehabilitation~     (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in~     general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability~     at fourteenth and third month, functional improvement at third month, the frequency of~     deaths and incidence of complications due to immobility and quantify the time spent in~     hospital.~   "
104062|NCT01694979|"~     The pelvic floor and diaphragm work together in many different functions. Two important~     functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to~     maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The~     investigators don't know how much the pelvic floor lifts and squeezes during different types~     of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze~     during different types of breathing out.~   "
104063|NCT01694966|"~     Evaluation of the histologically proven adenoma and carcinoma detection rate in patients~     undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with~     200 mg of Methylene Blue MMX® tablets.~   "
104064|NCT01694953|"~     This is a multi-center natural history study of MNGIE (Mitochondrial NeurogastroIntestinal~     Encephalopathy). Patients will be followed over time to assess clinical symptoms. The~     investigators hope to learn more about the disease of MNGIE as well as develop useful~     measures of disease status for use in future clinical trials.~      Additional clinical centers will be listed as they become available.~   "
104065|NCT01694940|"~     The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact~     registry and tissue biorepository for patients with mitochondrial disorders.~   "
104066|NCT01694927|"~     The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells~     intralesional transplantation as a safe and potentially beneficial treatment for patients~     with spinal cord injury.~   "
104067|NCT01694914|"~     At present, all commercially available corneal organ culture media contain foetal calf serum~     (FCS) and sometimes other compounds extracted from animals. These compounds are necessary~     for corneal cell survival but are problematic because they theoretically have risk of~     anthropozoonosis transmission, especially for new variant of CJD and the variability between~     FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo~     validation of a new medium free compound animal. We proved its superiority over conventional~     medium containing 2% FCS for endothelial cell survival during the storage time. The goal of~     this clinical trial is now to assess its superiority in patients.~   "
104068|NCT01694901|"~     This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic~     (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to~     optimized outcome compared to manually controlled clinical anesthesia and computerized~     Electroencephalogram (EEG).~   "
104069|NCT01694888|"~     Midwives are responsible for documenting and keeping care facts in midwifery departments.~     Inaccurate documentation or even minute error in reporting may lead to burdensome~     responsibility for midwives. This study has been conducted aimed to compare midwifery~     students' performance before and after teaching fundamentals of documentation. In this~     quasi-experimental study, 28 midwifery students were participated. Data were collected by a~     questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary~     patient with physician order and a checklist contain 11 elements of documentation~   "
104102|NCT01694459|"~     International guidelines support the use of a full-dose heparin (anticoagulants) during~     coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances~     in angioplasty techniques and the widespread use of pretreatment with two antiplatelet~     agents.~      Thus the investigators designed a study comparing safety and efficacy of standard dose~     heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty~     who are on aspirin and clopidogrel at the time of the procedure.~   "
104070|NCT01694875|"~     The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER~     System in cervical cancer screening.~      This objective will be accomplished in the ASC-US Study by evaluating the performance~     characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of~     women with ASC-US Pap test results who were 21 years of age or older (≥21 years of age) at~     the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by~     evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at~     increased risk of cervical disease in a sample population of women with negative~     (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.~   "
104071|NCT01694862|"~     The overarching aim of the Integra Initiative is to strengthen the evidence base on the~     impact of integrating family planning (FP), postnatal care (PNC) and HIV services in~     sub-Saharan Africa. Specifically, in the study the investigators aim to test the following~     hypotheses:~      the provision of integrated services, compared to separate services, will:~        1. lead to increased uptake of a range of SRH services .~        2. attract a greater number and diversity of clients.~        3. lead to increased quality of a range of SRH services~        4. lead to healthier sexual and reproductive behavior.~        5. lead to reduced stigma at health facilities.~        6. lead to the more efficient use of resources, with a lower unit cost of provision of key~          services.~      For the purposes of this study integration is defined as offering clients both HIV and~     postnatal care (PNC) or HIV and family planning (FP) services in the same visit.~      To better understand how services can be integrated in different countries this study~     focuses on two key models of integration in Kenya and Swaziland.~        -  The first model focuses on integration of FP and HIV services (integrated FP model) and~          entails performing HIV testing, STI screening and management, cervical cancer~          screening, condom promotion within FP consultations, as well as active referral to~          antiretroviral (ART) units for HIV-positive clients. The FP model will be evaluated in~          Kenya only.~        -  The second model focuses on integration of PNC and HIV services (integrated PNC model)~          and will be implemented in both Kenya and Swaziland. The model focuses on the provision~          of PNC services to mother and baby, FP services, repeat HIV testing for mother, HIV~          testing for infant and referral to HIV services for HIV positive mothers and infants,~          as well as referrals for clients requiring other additional services.~   "
104072|NCT01694849|"~     Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting~     from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis~     and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease)~     is considered as the most common form of chronic liver disease in adults in the United~     States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30%~     of the adult population.~      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to~     hepatic steatosis associated with inflammation and liver cell injury upon microscopic~     examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis~     and deserves serious medical management. Up to now, there is no effective drug which has~     clearly demonstrated therapeutic efficacy which may help lifestyle and dietary~     recommendations in the resolution of NASH.~      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the~     treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with~     the metabolic syndrome and type 2 Diabetes.~      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once~     daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver~     biopsy assessments.~   "
104073|NCT01694836|"~     Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to~     assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula~     alba (Birch) - versus placebo.~   "
104074|NCT01694823|"~     In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet~     technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating~     Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.~   "
104075|NCT01694810|"~     The study will assess safety and tolerability of different doses of topical gel containing a~     new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of~     healthy volunteers with high counts of Propionibacterium acnes. The test product will be~     applied once daily for 4 weeks. Exploratory measures include whether the topical product~     decreases the amount of a bacteria associated with acne (P. acnes).~   "
104076|NCT01694797|"~     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol~     Succinate Extended-Release Tablets 50 mg under fasting conditions~   "
104077|NCT01694784|"~     Most prevention efforts focus on promoting services (e.g. vaccination, screening tests).~     While some of these services have clear net benefit, many instead have possible or clear net~     harm. Currently, three quarters of services graded by the U.S. Preventive Services Task~     Force (USPSTF) have possible or clear net harm (C, I, and D services). Many of these~     services are delivered in healthcare settings at higher rates than what might be expected~     based on their potential for harm. This leads to adverse outcomes, excess costs, and missed~     opportunities to deliver more quality care. An important issue in delivering prevention~     messages is how to shift toward a focus on the appropriateness of prevention: encouraging~     services with clear net benefit and either discouraging or reducing demand for services with~     possible or clear net harm. Unfortunately, little is known about what drives overuse of~     potentially harmful screening services or how to make harms relevant to patients.~      This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to~     1) assess factors associated with intent to receive possibly or clearly harmful screening~     services and 2) determine whether and how patients' plans to get screened change with~     various presentations of information about harms (e.g. qualitative, quantitative, narrative,~     framed). The investigators will focus on three types of screening services: osteoporosis~     screening (previous C recommendation and now no recommendation for women < 65 years old with~     no fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for~     all men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).~   "
104078|NCT01694771|"~     The overall objective of this study is to assess efficacy and safety of 12 weeks, once~     daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat®~     Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to~     tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.~   "
104079|NCT01694758|"~     OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which~     will include patients suffering from diabetes type 2, treated or untreated, insulin~     dependent or not insulin dependent.~      In this study we aim to explore at a primary care level whether the use of benchmarking~     against a set of guideline-based reference values on a patient basis, may improve quality of~     patient care, in particular control of diabetes, lipids and blood pressure.~   "
104920|NCT01683799|"~     The purpose if the study is to determine whether improving sleep, especially slow wave or~     deep sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity~     and inflammatory responses to pain, and improves OA-related pain.~   "
104080|NCT01694745|"~     EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices~     regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in~     different countries in Europe. This study is conducted as part of the NeoOpiod study.~      The main objective of this study is to determine the current clinical practices regarding~     the use of sedative and analgesic drugs in newborns in intensive units in different~     countries in Europe. The principal criteria are: the frequency of ventilated neonates~     receiving sedation and analgesia, the medications used for sedation and analgesia in~     ventilated neonates, the length of use of medications administered for sedation and~     analgesia in ventilated neonates and similarities and differences in sedation and analgesia~     practices among European countries.~      The secondary objectives are: a) to determine the proportion of neonatal units that have~     developed and implemented local written guidelines to provide continuous sedation and~     analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b)~     to document the published guidelines for neonatal analgesia and sedation in different~     European countries and develop consensus for common European standards that can be applied~     in all medical settings, c) to determine the frequency of use of pain assessment tools in~     ventilated newborn infants and evaluate their impact on pain management practices and d) to~     determine practices to assess and prevent withdrawal syndromes.~      The EUROPAIN STUDY is observational and therefore it will not interfere with routine~     practices of participating units. No changes in diagnostic, therapeutic or any managing~     strategy of patients are imposed by the participation in this study. This epidemiological~     study will only collect data on clinical practices in each unit. It will include all~     neonates up to a corrected age of 44 weeks post conception.~      The maximum duration of data collection for every included infant is 28 days. Data~     collection will stop before 28 days if the infant leaves the unit (discharge, death,~     transfer to another hospital). Data will be entered on a secure web-based questionnaire.~   "
104081|NCT01694732|"~     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the~     bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to~     become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of~     the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain~     active smokers. Brittany is the second region of France facing an abnormal high death rate~     related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the~     evolution of the disease, the frequency of the exacerbations and the the mortality. Besides,~     smoking cessation is associated with a reduced risk of cardiovascular events and cancer.~     Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such~     population. Furthermore, smoking cessation has been underestimated in several studies. Most~     of these studies evaluated various methods of smoking cessation in COPD patients performed~     after an exacerbation, which has a hospitalization related mortality of approximately 10%.~     Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to~     cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is~     reported to be one of the most effective pharmacotherapies for smoking cessation. However,~     it has never been evaluated at the acute phase of an exacerbation of COPD requiring~     hospitalization.~   "
104082|NCT01694719|"~     The purpose of this study is to evaluate the potential effects of a cognitive training~     program when combined with a particular form of psychotherapy (behavioral activation~     therapy) for depression. Behavioral activation therapy targets changes in behavior as a~     method for improving a depressed individual's thoughts, feelings, and overall quality of~     life. This study is designed to test whether a computerized brain exercise called cognitive~     control training can enhance the effects of a 5-session behavioral activation therapy~     program. CCT has been shown to reduce depressive symptoms in two other studies, but it has~     not yet been combined with behavioral activation therapy. The investigators hypothesize that~     individuals assigned to the behavioral activation plus cognitive control training condition~     will demonstrate reduced depressive symptoms from pre to post treatment compared with those~     assigned to the behavioral activation plus computerized control condition. The investigators~     hypothesize that these gains will be maintained at one-month follow up.~   "
104083|NCT01694706|"~     The primary objective of this trial is to investigate the effect of food and of gastric pH~     increase on the relative bioavailability of faldaprevir.~   "
104084|NCT01694693|"~     Database analysis:~        -  To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)~        -  To describe joint population of Orencia~        -  To assess the impact of the treatment on health status of the treated population as~          assessed by morbid-mortality criteria~        -  To describe therapeutic strategies and use of health services~   "
104085|NCT01694680|"~     The purpose of the I-TEAM project is to assess whether there is a change in visual function~     and status of the retina after a year of intervention in subjects with early signs of~     Age-related Macular Degeneration.~   "
104086|NCT01694667|"~     The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial~     which will assess changes in hyperactivity in children ages five through eight with an~     autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer~     this question, this study will assess changes in hyperactivity as measured by the Aberrant~     Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity~     who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.~     The overwhelming majority of study procedures, including recruitment, informed consent,~     assessment of inclusion and exclusion criteria, and collection of baseline and outcome~     measures will take place over the internet.~   "
104087|NCT01694654|"~     1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in~          the German spoken part of Switzerland.~        2. To define the role of immunohistochemical and molecular techniques, such as~          immunostaining, FISH and mutational analysis regarding their ability to predict~          malignant behavior in terms of prediction of overall survival and disease-free~          survival.~   "
104088|NCT01694641|"~     A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo~     selection technologies are inefficient in identifying the embryo with the highest~     implantation potential. Time lapse (TL) embryo monitoring provides additional information~     about embryo development and therefore may aid embryo selection. The investigators aim is to~     study whether TL monitoring is superior to traditional embryo observation when a single~     blastocyst is selected for transfer (ET).~   "
104089|NCT01694628|"~     The purpose of this study in patients with advanced COPD and depression is twofold:~        1. Determine the feasibility and acceptability of a 6-session e-counseling intervention~        2. Determine the efficacy of the e-counseling intervention on depressive symptoms~      We hypothesize that patients who participate in e-counseling will have improved depressive~     symptoms compared to patients receiving usual care at 8 weeks.~   "
104135|NCT01694030|"~     The purpose of this study is to explore whether asking participants to visualise a secure~     attachment figure or a neutral event leads to differences in self-reported felt security or~     depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep~     a secure prime activated over 3 days via text message visualisation tasks.~   "
104090|NCT01694615|"~     Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and~     for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.~     It is recognized that standard forceps biopsies underestimate the presence or degree of~     airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have~     been shown in the literature to provide larger samples without crush artifact in a safe~     fashion in lung cancer patients. The aim of this study is to determine if transbronchial~     cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample~     size, architecture and the diagnosis of early rejection in lung transplant recipients which~     if discovered earlier may improve survival.~   "
104091|NCT01694602|"~     The overall aim of this research is to develop a non-invasive approach to evaluate the~     production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining~     which patients are at high risk for future development of cancer induced skeletal muscle~     atrophy.~      Rationale: The approach is based on the hypothesis that after an oral dose of deuterated~     3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours~     post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the~     rate constant for myofibrillar protein degradation and can be determined from spot urine~     samples.~   "
104092|NCT01694589|"~     We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result~     in inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no~     effect on autocrine signaling in the tumor cell compartment. Furthermore we hypothesize that~     treatment with LDE-225 will result in changes in the tumor stroma (decreased desmoplasia,~     increased vascularity) that will result in improved tumor blood flow.~      The purpose of this study is to determine if, where and how LDE-225 works in pancreatic~     cancer. A cancer cell's growth can depend on the cells and tissue around it. The cells and~     tissue make chemical signals to influence the cancer's growth. This research study is~     evaluating LDE-225 designed to interfere with one of the growth signals causing pancreatic~     cancer growth.~   "
104093|NCT01694576|"~     By this clinical trial, the investigators are trying to give an answer to such a question.~     Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and~     platinum after concurrent chemoradiation?~   "
104094|NCT01694563|"~     The primary objective of this post-approval study is to evaluate the clinical outcomes in a~     cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or~     long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation~     System by physicians performed the Maze IV procedure.~   "
104095|NCT01694550|"~     The aim of this study is to examine a correction term for an adapted QT interval during~     ventricular pacing (right, left and biventricular pacing) to obtain valid formulae~     correcting for the QT intervals in various pacing conditions.~   "
104096|NCT01694537|"~     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.~     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major~     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight~     Proteins (LLP). This enzym can be transported to the bloodstream via intestinal epitel.~     Structure of DLBS1033 looks like lumbrokinase. Lumbrokinase is enzym that consist of 6~     isoenzyme serine protease. As a drug that consists of serin protease enzym, suspected that~     the mechanism of action of DLBS1033 similar with lumbrokinase, especially as plasminogen~     activator in fibrinolytic system. In vitro study by Trisina et al showed that DLBS1033 has~     fibrinogenolytic activities on fibrinogen α, beta, and gamma chain, decreasing platelet~     aggregation and clotting time was prolonged. Until now, the mechanism of action and effects~     of DLBS1033 on human fibrinolytic and coagulation system still unknown. Therefore, the aim~     of this clinical trial is to evaluate the effects of DLBS1033 on human fibrinolytic and~     coagulation system on healthy subjects.~   "
104097|NCT01694524|"~     Few studies dealing with the risk of infectious of nervous system and the utility of lumbar~     puncture and of emergent neuroimaging among patients with simple febrile seizure between 3~     and 11 months age and with complex seizure has been reported. None of these studies was~     multicentric. Recommendations about management of these children are heterogeneous.~      The investigators aim to study by an observational retrospective multicentric study the rate~     of infectious of central nervous system among patients with a complex febrile seizure and~     among patients between 3 and 11 months age with simple febrile seizure.~   "
104098|NCT01694511|"~     The purpose of this study is to determine whether High Resolution Magnification Endoscopy~     (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to~     conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic~     epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in~     patients with Barrett's Esophagus (BE).~   "
104099|NCT01694498|"~     The purpose of the study is to investigate the efficacy and safety of two different dose~     levels of desmopressin orally disintegrating tablets against placebo for the treatment of~     nocturia in adult men during 12 weeks treatment~   "
104100|NCT01694485|"~     This is a randomized, double blind, placebo controlled, parallel group, multiple dose study~     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of~     subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at~     week 8. After completing all screening assessments and meeting all eligibility criteria,~     subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A~     maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed~     in the study. At the end of the double blind period, subjects will enter an open label~     period during which all subjects will receive open label AMG 181 at a single dose level~     according to protocol. Subjects who failed to achieve a response at week 8 and also have an~     inadequate response at week 12 or after are eligible to enter the open label period of the~     study early. Subjects who achieved response and/or remission at week 8 and subsequently~     experience disease worsening are eligible to enter the open label period early ONLY if a~     confirmatory rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects~     that complete the open label period or early terminate from the study will enter the 2 year~     safety follow up period.~   "
104101|NCT01694472|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of~     MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients,~     such as malignant melanoma and lung cancer.~   "
104103|NCT01694446|"~     Increased postprandial plasma triglycerides are associated with increased cardiovascular~     risk. Chronic consumption of carbohydrates is associated with increased levels of~     triglycerides. Very few studies have assessed the effect of acute consumption of~     carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present~     study aims to assess the effects of acute administration of glucose and fructose on hepatic~     and intestinal lipoprotein production.~   "
104104|NCT01694433|"~     The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene,~     also known as Dovonex) on the face and on the bacteria that cause acne. The information~     gained from this study may lead to new treatments for acne. In this study, Calcipotriene~     will be compared with a placebo, a cream that looks like Calcipotriene, but contains no~     active ingredients.~   "
104105|NCT01694420|"~     This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF~     [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV~     Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and~     study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48,~     clinical care but not study drug will be provided through week 96. A study participant~     suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.~      The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV),~     cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly~     reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The~     secondary hypotheses to be considered are 1) virologic response rates as measured by plasma~     HIV RNA levels will be non-inferior or superior to a historical group of participants from~     the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with~     EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with~     ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune~     activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+~     will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset~     of participants samples will be obtained from compartments such as the gastrointestinal~     tract, and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA,~     immunologic responses to HIV, and tissue and anatomic reservoirs. We hypothesize that~     treatment with the ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these~     compartments as compared to historical controls treated with EFV/FTC/TDF. 5) in a subset of~     participants who remain suppressed on therapy, resting CD4 cells with replication-competent~     HIV-1 (latent reservoir) will be quantitated and compared to similar measurements in PHI~     participants treated with EFV/FTC/TDF. In addition, we will compare these results to those~     measured in HIV-1 infected participants treated and 6) ELV/COBI/FTC/TDF will be well~     tolerated, and the proportion of participants who require treatment modification will be~     less than that observed in participants treated with EFV/FTC/TDF.~   "
104106|NCT01694407|"~     This prospective, double-blinded, randomized, parallel cohort study will examine the genital~     and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and~     disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2)~     Emtricitabine (FTC) alone; 3) TFV combined with FTC; and 4) placebo. Participants will be~     randomized to treatment group, to number of tablets to be inserted in the Single Use Phase~     (1 tablet or 1 tablet followed by a second tablet two hours later to mimic the BAT24 dosing~     regimen), and to one of four collection time points (2, 4, 6, or 24 hours after tablet~     insertion) for assessments only after the last dose of the Multiple Use Phase.~      In the Single Use Phase of the study, the participant will insert one tablet in the clinic~     to estimate times to disintegration and disappearance. Those randomized to two tablets will~     insert a second tablet 2 hours later. In all women, sample collection will occur 5 hours~     after the initial tablet insertion.~      In the Multiple Use Phase of the study, participants will insert a tablet once daily for 14~     days. The 1st, 7th, and 14th tablets will be inserted in the clinic; the remaining tablets~     will be inserted at home. The clinic will call the participant on day 3 of the multiple use~     phase to ask about any symptoms the participant may be experiencing. Each insertion in the~     clinic will be followed by sample collection and, at Visits 4 and 6, colposcopy at the~     participant's assigned time point.~   "
104107|NCT01694394|"~     The primary objective of the study is to determine the rate of detection of sub-clinical~     atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St.~     Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular~     risk factors and left atrial enlargement, but without prior AF.~   "
104108|NCT01694381|"~     Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective~     thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to~     urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase~     (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor.~      The primary objectives of the study are:~        -  To assess the overall safety and tolerability related to systemic plasminogen~          activation of single doses of M5 over a wide dose range (study part I).~        -  To assess the effect of single doses of C1-inhibitor on the overall safety and~          tolerability of single doses of M5 and its effect on M5-induced coagulation changes~          (study part II).~   "
104109|NCT01694368|"~     To characterize atherosclerotic coronary artery plaques using advanced intra-coronary~     imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter~     before and after percutaneous intervention~   "
104110|NCT01694355|"~     It is well known that postmenopausal women are at risk for osteoporosis. The study~     hypothesis is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with~     osteomalacia and will cause low BMD estimation in DXA scan due to insufficient bone~     mineralization.~      We assume that among these postmenopausal women, Vitamin D treatment will improve bone~     mineralization and will cause a rapid increase in BMD. According to the results,~     bisphosphonates therapy may be an unnecessary treatment.~      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its~     correction on Bone Mineral Density (BMD) in postmenopausal women.~   "
104111|NCT01694342|"~     Telomerase, through its regulatory function on telomere length may play an important role in~     immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty~     liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress~     to cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully~     understood.~      Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral~     lymphocytes of patients with fatty liver, compared to healthy controls. This finding could~     explain the telomere shortening found previously in these patients by our group [20] and~     others [21]. Furthermore, we found higher rates of TC in these patients, probably due to an~     attempt to counteract the shortening of the telomeres and to stabilize them. This is through~     a different mechanism that is not telomerase-mediated.~      Telomere capture is considered an alternative way to maintain telomere length and~     chromosomal stability [3]. It is a more common mechanism for chromosome stabilization and~     repair, in contrast to the telomerase-mediated process of chromosome healing and elongation~     This study aimed to evaluate mechanisms of telomere homeostasis like telomere shortening,~     telomerase activity, telomere capture and aneuploidy in patients with NAFLD in order to~     explain previous findings of telomere shortening in these patients.~   "
104112|NCT01694329|"~     The objective of this study is to document the residual burden of acute upper respiratory~     infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and~     auditory functional and anatomical abnormalities in children under the age of 5 years in~     Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison~     groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)~     and those exposed to PCV-7 exclusively (those born in 2003-2007).~   "
104113|NCT01694316|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in alleviating symptoms and improving emotion regulation in veteran's with~     PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid~     development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin~     Lab at Stanford University in California, but participants from the entire US are welcome to~     participate as the study is delivered online.~   "
104114|NCT01694303|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in improving cognition and emotion regulation in a college freshmen population.~     It will increase understanding of emotion-regulation and cognition at a neural-circuit level~     and aid development of new interventions for emotion regulatory problems.~   "
104115|NCT01694290|"~     A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are~     used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.~      The ability of these to cool a person has never been quantified, the efficiency and extent~     of cooling, as well as location of placement of ice packs is purely anecdotal. The purpose~     of this study is to determine whether strategically placed chemical ice packs will provide~     benefit to individuals subjected to heat stress.~   "
104116|NCT01694277|"~     The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to~     sunitinib at 50 mg/day~   "
104117|NCT01694264|"~     Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic~     rheumatic disease, especially rheumatoid arthritis~   "
104118|NCT01694251|"~     Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the~     intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the~     severity of MS before the repair and excluding residual MS for immediate determination of~     the success of the repair procedure and postoperative prognosis. For this purpose, several~     methods have been applied by introperative transesophageal echocardiography (TEE): pressure~     half-time (PHT) of mitral inflow Doppler and 2-dimensional (2D) planimetry methods have been~     widely used in clinical practice. However, especially after MVP, the PHT method is usually~     unreliable because it usually underestimates the MVA due to various intraoperative~     hemodynamic factors.~      The authors hypothesized that the MVA determined by 3D TEE would be more accurate than that~     by PHT during immediate post-MVP procedure in severe MS patients and comparable to~     postoperative MVA determined by MDCT. Therefore, the present study determined the MVA by~     using PHT, 3D planimetry and MDCT before and after the MVP procedure in severe MS patients~     and analyzed them to evaluate 3D TEE's utility for evaluation of MVA.~   "
104119|NCT01694238|"~     An investigation on the difference in stoma hernia frequency related to surgical technique~     when incising the fascia. All patients planned for elective colostomy formation are to be~     included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's~     procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting~     colostomy for any reason are all included.~      The three groups for randomization are:~      A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall~     fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is~     the parastomal hernia rate within 12 months from index surgery. Secondary end-points include~     clinical variables, re-admission and/or re-operation due to any stoma complication, quality~     of life and health economy analyses, at 12 months.~   "
104120|NCT01694225|"~     This study aims to establish the feasibility of using a monthly bubble package to improve~     compliance rates among women prescribed adjuvant endocrine therapy.~   "
104121|NCT01694212|"~     Diabetes has many negative effects on patients' general health. Among many other~     consequences it speeds up the cataract formation and that is why diabetic patients need~     cataract surgery very often. The known side effect of cataract surgery even in otherwise~     healthy patients is postoperative edema of the back of the eye (what causes decrease of~     vision), which has greater incidence especially in patients who have diabetic eye problems.~     The cause of that might be the intraocular inflammation which was previously demonstrated to~     be significantly more prominent in patients with untreated diabetic eye problems. Therefore~     we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract~     surgery prevent the formation of the edema of the back of the eye.~   "
104122|NCT01694199|"~     The clinical study's primary objective is to compare the overall analgesic effect of the~     Provant Therapy System (test device) to an identical sham device (placebo) in subjects~     experiencing post-operative pain following first metatarsal bunion surgery. The study~     hypothesis is that, over the first 72 hours (3 days) after the initial test device~     treatment, subjects treated with an active test device will show a statistically significant~     difference (reduction) in pain intensity scores when compared with subjects treated with a~     sham (placebo) device. Treatment with the test device will continue through the 168 hour (7~     day) timepoint. Safety will be followed through 28 days.~   "
104123|NCT01694186|"~     This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to~     evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)~     insert for the management of subjects with non-infectious uveitis affecting the posterior~     segment of the eye. Patients will be randomized to receive either a sham injection or the~     FAI insert and will be observed for three years following treatment.~   "
104124|NCT01694173|"~     Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus~     patients after the same have been labelled with positron emission tomography tracer F18-FDG;~     as it is assumed that the therapeutic outcome will profoundly depend on the delivery of~     these cells to pancreas. Biodistribution and quantification studies will be done at 30~     minutes and 90 minutes of stem cell infusion.~   "
104147|NCT01693874|"~     The investigators are developing and then testing whether Mindfulness-Based Stress~     Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and~     depressive symptoms and improves cognitive functioning in older adults.~   "
104125|NCT01694160|"~     The main objective of this study is to examine if paricalcitol may reduce progression of~     graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus~     have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses~     are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator~     indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an~     anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol~     is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials~     with paricalcitol are performed in renal transplant patients examining the effect on~     proteinuria and graft fibrosis.~   "
104126|NCT01694147|"~     To investigate the possible mechanisms of pulmonary and systemic permeability change~     including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in~     patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome~     (ARDS).~   "
104127|NCT01694134|"~     The treatment of chronic low back pain is a major objective of public healthcare, because it~     causes an important number of sick leaves. A correlation between clinical observations and~     an inflammatory discopathy has been underlined, but there is currently any reference~     treatment. In this study, the main objective is to assess the efficacy of an intradiscal~     injection of corticoids versus local anaesthetic on the treatment of pain of patients with~     low back pain associated to a Modic I discopathy.~   "
104128|NCT01694121|"~     The purpose of this study is to evaluate the effectiveness of the MEN Count intervention, an~     HIV intervention and prevention program for heterosexual Black men. The MEN Count model~     integrates HIV risk reduction and gender-equity counseling with housing and employment case~     management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day~     period. MEN Count was developed and pilot tested using a CBPR approach via funding from an~     NIH R21, in Boston, MA. A more larger scale, two-armed quasi-experimental controlled trial~     design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic~     and other community-recruitment methods in Washington, DC. Study participants (N=504) will~     be Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female~     sex partners in the past 6 months] and either current unemployment or homeless in the past 6~     months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design~     will be conducted in which participants will receive either MEN Count or an attention~     comparison program similar to MEN Count in structure. We will assess program impact on~     reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia,~     gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12~     month follow-ups. Additionally, quality assurance and process evaluation efforts will be~     conducted to ensure high quality program adherence and delivery, as well as to support~     program replication should the model prove effective.~   "
104129|NCT01694108|"~     In high-income societies the use of health care and medication is steadily increasing.~     Children have high morbidity, many visits at the general practitioner, an increasing number~     of hospitalisations, and an increasing use of medication. And, when children are ill,~     someone has to stay home to care for them. An un-explained global increase in the incidence~     of the allergic diseases eczema, wheezing, asthma and allergies means that 25% of~     high-income populations are affected. Cheap preventive measures are highly warranted. Recent~     studies have shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG)~     immunisation on neonatal mortality in low-income countries and suggested a positive,~     non-specific effect on allergic disease in high-income countries. Non-specific means that~     the vaccine effect goes beyond prevention of the targeted disease, i.e. the BCG vaccine~     benefits the health status of the immunised individual in ways unrelated to protection~     against tuberculosis (TB). For instance, in a recent randomised trial in West Africa the~     investigators showed that the BCG vaccine at birth was safe in low birth weight (LBW)~     infants and significantly reduced neonatal mortality in these children, with a significant~     long-lasting effect on infant mortality in the smallest newborns with a birth weight <1.5~     kg. There is an urgent need to explore the huge potential of the BCG's beneficial~     immune-stimulatory effects among children in high-income populations.~      Therefore, the investigators will carry out a large prospective randomised clinical trial in~     Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at~     birth experience 20% fewer hospitalisations during early childhood.~      Secondary outcomes~        1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed~          less antibiotics during early childhood than non-BCG-immunised infants.~        2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop~          less eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age:~          self-reported, diagnosed by a physician, or found at clinical examination; and are~          prescribed less anti-eczema/asthma/allergy medication during early childhood than~          non-BCG-immunised infants.~        3. To test the hypothesis that infants who receive the BCG at birth respond in~          paraclinical measures: Specific IgE, thymic gland size, leucocyte count and~          differentiation, monocyte memory, cytokine profiles, and antibody titres following~          immunisation against diphtheria, tetanus, pertussis, pneumococcus, hemophilus.~        4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth~          measures: weight, length and head circumference.~        5. To test the hypothesis that infants who get the BCG vaccine at birth respond with~          decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting,~          acute otitis media, febrile convulsions.~        6. To test the hypothesis that premature infants with gestational age less than 37 weeks~          who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages~          and Stages scores.~        7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected~          coverage with the subsequent vaccinations in the Child Vaccination Programme.~        8. To test the above mentioned hypotheses specifically in the strata of premature and~          low-birth-weight Danish infants.~   "
104130|NCT01694095|"~     Age-related macular degeneration is one of the leading causes of blindness worldwide. The~     factors that induce the progression of geographic atrophy, the advanced form of dry~     age-related macular degeneration, remain poorly understood. The aims of this study are to~     describe the natural history of geographic atrophy and identify potential risk factors~     associated with a faster spread of atrophy that may be used to develop rational therapies.~   "
104131|NCT01694082|"~     Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally~     utilized with Australian students, is unique in that it contains efficacious components~     derived from motivational interviewing (e.g., personalized feedback) and cognitive~     behavioral therapy (protective behavioral strategies), yet is very brief and has established~     efficacy. This study aims to test versions of THRIVE tailored to American college students.~     In addition to replicating original results with THRIVE, we will also test versions~     containing unique subsets of protective behavioral strategies to reduce alcohol consumption.~     The primary hypothesis is that versions of THRIVE will be associated with lower overall~     alcohol consumption than an assessment and brief brochure control condition.~   "
104132|NCT01694069|"~     Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and~     infection. A majority of people with cystic fibrosis have large quantities of bacteria~     residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas~     aeruginosa.~      Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics~     to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the~     antibiotics frequently used to treat this bacteria is piperacillin-tazobactam.~     Piperacillin-tazobactam is thought to be the most effective when there is a constant level~     of drug in the body. The standard way to administer piperacillin-tazobactam is to give~     several grams 4 times each day as a 30 minute infusion. An alternative way to give~     piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more~     likely that drug will remain at a constant level in the body. The objective of this study is~     to determine if administering piperacillin-tazobactam as a continuous infusion is more~     effective at treating people having a pulmonary exacerbation of cystic fibrosis than a~     standard 30 minute infusion, 4 times a day.~   "
104133|NCT01694056|"~     Soy protein has a high biological value, and contains several potential health-related~     nutritional factors, i.e. its amino acids pattern, biological active peptides and~     non-protein compounds such as isoflavones. In the field of obesity and blood lipids soy~     protein is well-studied and appreciated; it improves circulating blood lipids and is~     associated with weight reduction. The effect of soy on insulin resistance, glucose~     homeostasis and the metabolic syndrome is less frequently studied. However, several~     molecular mechanisms of action of soy protein make it a promising approach.~   "
104134|NCT01694043|"~     The purpose of the study is to investigate the effect of watching a television show with~     healthy food commercials, unhealthy food commercials, or neutral commercials on the~     consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1)~     Women exposed to a television show with commercials imbedded advertising food will consume~     more food than women exposed to a television show with non-food related commercials.~      2) Women will consume more food when exposed to a television show with commercials~     advertising unhealthy food as compared to a television show with commercials advertising~     healthy food.~      3) Women will consume the most food when exposed to a television show with unhealthy food~     commercials and have unhealthy snack foods available to consume.~   "
104136|NCT01694017|"~     The purpose of this study is to compare clinical, economical and quality of life (QOL)~     outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen.~     This study will be an unblinded randomized trial. The first step will be empirical data~     collection for one year for calculating the incremental cost effectiveness ratio (ICER). The~     second step will be to perform a simulation model for calculating long term ICER.~   "
104137|NCT01694004|"~     Preliminary studies in humans suggest that the presence of lipids in the gut can modify~     glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid~     sensing in the duodenum has a significant role in modifying nutrient (glucose and amino~     acid) absorption from the GI tract through a gut-brain-gut axis.~   "
104138|NCT01693991|"~     Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient~     number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both~     men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced~     cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi~     acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to~     complete the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4~     or 6 months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most~     helpful? 4)What sample size is needed for a full study? Full-study research questions:~     Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in~     life among newly diagnosed ACP, compared with those receiving usual care plus meetings with~     an empathic non-professional visitor (i.e., attention-control group or AC) or usual care~     alone (UC), at x months post-randomization? (time determined in pilot) Meaning in life~     (primary outcome) is defined as the belief that one's life has significance and purpose~     (i.e., global meaning) and newly diagnosed ACP is defined as the 6 months after first~     occurrence of, progression toward, or recurrence of stage III or IV cancer (TNM~     classification system). Secondary: In our future full-study, we plan to evaluate MMi effects~     on secondary outcomes such as existential wellbeing (MQOL existential wellbeing) and~     posttraumatic growth (Post-Traumatic Growth Inventory). We also plan to test a theoretical~     model where sense of meaning in life has a protective (moderating) effect on tertiary~     outcomes such as physical QoL (MQOL physical subscale), anxiety and depression (Hospital~     Anxiety and Depression Scale (HADS)), and overall QoL (MQOL Total) in EG patients.~     Methodology: RCT pilot study with 60 newly diagnosed ACP (stages III or IV) within 2 months~     of referral and 6 months of randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC.~     Patients will complete self-report questionnaires (including outcome measures, as well as~     sociodemographic and medical variables) at 2, 4 and 6 months post-randomization.~   "
104139|NCT01693978|"~     The aim of this research is to assess whether Contingency Management is effective in~     improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD.~     Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few~     studies of this treatment in substance users have shown poor adherence. Contingency~     Management is a well-established approach that could be used to enhance adherence to PE.~     From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction~     Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD~     will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged~     Exposure with Contingency Management (PE+CM) condition that provides monetary-based~     incentives for attending the PE therapy sessions. The comparison condition will be assigned~     to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The~     PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups~     will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms,~     and rates of drug use (urine specimens, self-reported use). The study's three primary aims~     are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD~     to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the~     efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD~     symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in~     SUD patients.~   "
104140|NCT01693965|"~     Bronchopulmonary infection is the most common and serious complication in the evolutionary~     course of cystic fibrosis (CF). Administration of antibiotics adapted to infecting pathogens~     is one of the key issues for its management. However, more than half of patients with CF~     have chronic respiratory infections for which infectious agent remains unknown leading to~     empirical antibiotic therapies that are not adapted to the causative agents. Recently, new~     technologies have been applied for the description and characterization of microbial agents~     in CF patients including molecular biology techniques that allowed us to detect and to~     identify new and/or emerging pathogens. Moreover, more sophisticated molecular techniques~     such as pyrosequencing and PCR amplification and cloning lead us to demonstrate the huge~     microbial diversity associated with chronic bronchopulmonary infections in this population.~     Otherwise, a metagenomic approach revealed the extraordinary complexity of the respiratory~     flora in these patients and, somewhat unexpected, abundance of anaerobes, viruses, and~     bacteriophages. In addition, it has been shown that some antibiotics commonly used in~     clinical practice for the treatment of respiratory infections were able to induce these~     bacteriophages, suggesting the existence of lateral gene transfer by transduction. The human~     microbiome is the set of microbial communities associated with the human body and represents~     all living microorganisms in the body. Its role in the immunity development has recently~     been demonstrated suggesting that changes in this ecosystem play a critical role in~     evolution of several human diseases. For example, in obesity it has been shown that there is~     a relationship between the intestinal human microbiota and nutritional and metabolic status~     of the hosts and specific alterations of these intestinal microbiota may represent a~     metagenomic signature of this disease. Evolution of the respiratory microbiota in patients~     with cystic fibrosis, whose nutritional status is often impaired (chronic malnutrition due~     to disorder of digestive absorption) and receiving regular antibiotic treatments remains~     unknown to date. Characterization of this ecosystem and its role is a critical step to~     understand the evolutionary course of the disease.~      The main objective of this seminal study is to describe and to characterize the respiratory~     microbiota from sputum samples obtained from a limited number of selected patients with CF~     from 5 regional care centers (CRCM) from South of France (Mucomed network) (2 patients per~     center : 6 adults and 4 children), with similar clinical, microbiological and functional~     status before and after a cure of antibiotics. Different microbiological tools will be used~     including axenic culture systems, co-culture on amoebae in order to to isolate and to~     identify the microbial communities. Identification of bacteria will be done using MALDI-TOF~     mass spectrometry and/or molecular techniques. Moreover, 16S rRNA PCR amplification followed~     by cloning and sequencing of PCR products from the same sputum sample will be carried out to~     identify and to compare the bacterial species identified using molecular methods. In a~     second step, once the respiratory microbiota was characterized, it will be interesting to~     develop a dedicated microarray that will allow to detect all the bacteria identified in the~     first stage of the project and to assess its relevance on a larger cohort of patients with~     CF by studying the correlation between the respiratory microbiota and clinical status of~     patients according to the prescribed antibiotic treatments.~      This study will open new clinical perspectives and will help us to determine the potential~     role of antibiotics on the microbiota evolution during treatment according to regional~     health care practices. This will contribute to better understand the role of the microbiota~     in the evolution of these chronic respiratory infections. It could be the first step for~     innovative therapeutic strategies, taking into account the balance of complex microbial~     flora and possibly evolving according to antibiotic therapies. It could also form part of a~     larger preventive strategy against transmission of specific pathogens in CF.~   "
104141|NCT01693952|"~     Treatment of cancer, and more particularly of haematological malignancies, partly relies on~     chemotherapy. Most therapeutic regimens display various toxicities, one of the most common~     being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia~     can be overcome by haematological growth factors and transfusion, one of the most severe~     life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite~     the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major~     limitation in chemotherapy which is responsible for the majority of treatment-related~     morbidity and mortality and for prolonged hospitalisation.~      In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic~     patients. While the occurence of neutropenia and sepsis is often unpredictable and thus~     difficult to study in a prospective way, stem cell transplantation represents a quite~     convenient model to study such a question. Autologous stem cell transplantation indications~     in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease.~     Briefly, after a mobilization procedure, a graft of patient's hematopoietic stem cells is~     collected by cytapheresis and frozen. When the patient has reached complete remission by~     conventional chemotherapy, he benefits from a very high dose myeloablative chemotherapy~     (called conditioning regimen). The conditioning regimen targeted to have high~     antitumoral activity leads to a cytokine storm resulting in a programmed inflammation.~     36 hours after the lasting of the conditioning regimen, the CD34+ cells are thawed and~     infused to the patient. Thus neutropenia usually begins at D4 post transplantation and lasts~     for 10 days, until graft becomes functional. Thus, the timing and duration of neutropenia~     are very homogeneous. During neutropenia, fever and sepsis are very frequent (>80%~     patients), thus, most patient will be informative regarding sepsis, and there is an easy~     possibility of biological sampling before programmed inflammation (due to conditioning~     regimen), after inflammation before sepsis, then during and after the sepsis. Since the~     patient is hospitalized, the kinetic monitoring is quite easy~   "
104142|NCT01693939|"~     The purpose of this study is to document the programmed flap thickness to achieved flap~     thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200~     Femtosecond laser is a precision surgical device that is used to create a flap in a FDA~     approved LASIK procedure.~   "
104143|NCT01693926|"~     The objective of the study is to evaluate the impact of physical activity in obese and~     nonobese prepubertal children on:~        1. biological stress responses during a psychosocial stress test~        2. snacking and feeling of hunger in response to the same psychosocial stress test~        3. the moderating factor of attachment on the biological stress responses and on snacking~      Children will be investigated on one study day during 3.5 hours.~   "
104144|NCT01693913|"~     That a treatment using a cognitive-behavioral treatment for exercise and nutrition support~     will be associated with greater weight loss that a treatment of nutrition and exercise~     education.~   "
104145|NCT01693900|"~     Surgical trauma causes nerve sensitization leading to amplification and prolongation of~     postoperative pain. In experimental studies, pre-injury neural blockade using local~     anesthetics has been shown to reduce post-injury sensitization of the central nervous~     system, while similar techniques applied after the injury had less or no effect (FILOS).~     Investigators have therefore designed this study to examine the timing of FICB~     (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing~     anterior hip replacement surgery.~   "
104146|NCT01693887|"~     The purpose of this study is to Comparison clinical efficiency with IPFI patients who~     treated by different protocols(empirical therapy or preemptive therapy) in ICU.~   "
104151|NCT01693822|"~     A-PREDICT is a study of axitinib in patients with metastatic renal cell carcinoma unsuitable~     for nephrectomy (as judged by the treating clinician) to evaluate efficacy, safety, toxicity~     and changes in biomarkers during therapy. Axitinib will given twice daily by mouth according~     to tolerability of treatment, for as long as patients are deriving clinical benefit. Blood~     and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers~     of treatment response. The primary clinical objective of this study is to define the~     activity of axitinib given to patients with metastatic renal cell carcinoma unsuitable for~     nephrectomy.~   "
104152|NCT01693809|"~     The principal aim of this study is to evaluate the presence of changes in cervical~     vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy~     subjects.~      Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service~     of the hospital.~   "
104153|NCT01693796|"~     The purpose of this study is to determine the average risk for thyroid irradiation for any~     type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100~     mSv, adjusted to the measured thyroid volume and to the patient's age.~   "
104154|NCT01693783|"~     This phase II trial studies how well ipilimumab works in treating patients with human~     papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other~     areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help~     kill them or carry tumor-killing substances to them.~   "
104155|NCT01693770|"~     Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for~     pain control through thermally-induced cell death and periosteal denervation caused by~     cortical heating relative to acoustic energy absorption. There is also evidence that a high~     intensity focused ultrasound beam can penetrate through the cortical bone to the medullary~     space, producing thermal necrosis of cancer tissue. However, little is known about the~     potential effects of MRgFUS as first line therapeutic modality for pain palliation in~     skeletal metastases.~      Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of~     painful bone metastases and determine the potential of this technique for local tumor~     control.~   "
104156|NCT01693757|"~     The purpose of this study is to compare hop performance and jump landing strategy in soccer~     players with higher level sports activities after ACLR using either BPTB or STG and~     controls.~   "
104157|NCT01693744|"~     Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material~     in an eye structures and many other parts of the body including kidneys and blood vessels.~     As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and~     endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.~      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic~     kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60~     mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,~     group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal~     kidney functions (control group). Demographic properties and the rate of PEX were evaluated~     and compaired between the groups.~   "
104158|NCT01693731|"~     The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex,~     Aromasin or Femara affect a woman's oral health and oral health related quality of life.~     Patients, dental professionals and medical oncologists will benefit from a greater~     understanding of the best oral care follow up practices of breast cancer survivors using~     aromatase inhibitors.~   "
104159|NCT01693718|"~     The goal of the study is to test a particular combination of drugs and determine their~     ability to completely eliminate head and neck cancer.~   "
104160|NCT01693705|"~     To determine the morbidity and mortality of patients who have undergone percutaneous~     tracheostomy due to respiratory failure in the critical care unit and after intensive care~     in the internal medicine department, including follow-up of quality of life of these~     patients.~   "
104161|NCT01693692|"~     The purpose of this study study is to determine whether TD-9855 is effective in treating~     patients with fibromyalgia.~   "
104162|NCT01693679|"~     • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver~     cirrhosis.~   "
104163|NCT01693666|"~     Gaining too much weight in pregnancy is associated with adverse pregnancy complications and~     can have a long-term impact on maternal and offspring health, including increased risk for~     obesity and metabolic disease. Preventing excessive gestational weight gain could reduce~     adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty~     obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned~     to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will~     be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.~     Women in the LIFE program will be given guidance on healthy eating and exercise at their~     regularly scheduled obstetric visits. To increase adherence to the program, a contingency~     management (CM) intervention offering incentives will be used to establish and maintain~     healthy nutrition and physical activity habits, working towards the goal of restricted~     weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled~     for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering.~     Primary outcomes include adherence to the LIFE program, weight change in pregnancy and~     postpartum, and objective measures of maternal and offspring health.~   "
104164|NCT01693653|"~     This is a double-blind placebo controlled study targeting individuals with active Behcet's~     Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to~     conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable~     dose for 4 weeks before enrollment. Prednisone or equivalent (< 10mg/day) permitted if dose~     stable for 6 weeks prior to enrollment.~      The study will investigate the safety of tocilizumab for this vasculitic condition in~     addition to its efficacy.~      The planned sample size is 30 participants per arm for a total of 60 participants. The study~     would be for 3 months, with a safety follow up at 2 months after study termination.~      Study participants will stay on their current treatments and either tocilizumab or placebo~     infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV~     8mg/kg Q 4 weeks X 3 doses or placebo.~   "
104165|NCT01693640|"~     Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's~     patients~   "
104166|NCT01693627|"~     A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:~        1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented~          femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy,~          Warsaw, Indiana) and~        2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral~          stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw,~          Indiana)~      There will be a further in-group randomisation to a Corail femoral stem with or without a~     collar, creating a number of 4 study-groups in total.~      The aims of the study are:~        -  To compare polyethylene wear and migration of the moderately cross-linked Marathon~          polyethylene in a cemented version(Marathon) and in an uncemented~          cup(Pinnacle/Marathon)~        -  To evaluate micromigration and periacetabular bone mineral density of the 2 cups using~          radiostereometry(RSA)~        -  To evaluate the migration patterns and proximal femoral bone density changes around the~          Corail stems with and without a collar~   "
104167|NCT01693614|"~     This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in~     patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell~     lymphoma (MCL) or follicular lymphoma (FL).~   "
104168|NCT01693601|"~     This is a single-center, single arm, dose finding study to assess safety and tolerability of~     the oral combination of Panobinostat and Ruxolitinib in patients with myelofibrosis (MF) in~     chronic and accelerated phase.~   "
104169|NCT01693588|"~     High levels of postoperative pain are associated with an increased risk of lung and heart~     complications, are the most common reason for delayed discharge or for unexpected hospital~     admission after ambulatory surgery, and are responsible for prolonged recovery after~     inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight~     gain and may have an impact on the patient's nutrition post operatively. The purpose of this~     study is to evaluate the effectiveness of a multimodality pain management protocol on~     postoperative neurosurgical pain.~   "
104170|NCT01693575|"~     The purpose of the study is to gather clinical data and safety information on the use of APX~     100 device for small-pupil cataract surgery and the management of intraoperative floppy iris~     syndrome (IFIS) during cataract surgery.~      The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile~     device for mechanical expansion of pupillary diameter during intraocular surgery. The APX~     100 is inserted to the anterior chamber of the eye through standard clear corneal incisions.~     The device is then located on the pupil's border between the iris and the anterior lens~     capsule and the pupil's diameter is expanded.~      The APX 100 will be used in standard phacoemulsification cataract extraction surgery when~     small pupil diameter (<4.5 mm) is recognized preoperatively or develops intraoperatively due~     to IFIS.~   "
104171|NCT01693562|"~     This is a multicenter, open-label, first-time-in-human study with a standard 3+3~     dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase~     in patients with advanced solid tumors. An exploration cohort has been added to determine~     the safety using Q4W dosing.~   "
104172|NCT01693549|"~     The purpose of this study is to determine whether cabazitaxel is effective in the treatment~     of metastatic breast cancer.~   "
104173|NCT01693536|"~     A randomised controlled trial to test if offering three visits to a dietician + two visits~     to a physiotherapist over six months + a home sphygmomanometer, will result in a reduction~     in sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled~     from Oct 2008 to July 2009.~   "
104174|NCT01693523|"~     The goal of this research study is to learn if pancreatic cancer and the FOLFIRINOX~     chemotherapy are associated with symptoms such as fatigue, pain, disturbed sleep, lack of~     appetite, and drowsiness, among others. Researchers also want to learn whether any symptoms~     you may have are related to markers of inflammation. Markers of inflammation are found in~     the blood and may be related to symptoms you may have.~   "
104175|NCT01693510|"~     Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG~     is a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy~     overweight or obese (a group that represents over 50 % of all pregnant women) and about 40%~     women of normal weight. Excess GWG is associated with complications of pregnancy, such as~     post-partum weight retention, type 2 diabetes, elevated fats in the blood, and high blood~     pressure and may also lead to problems with the health of the newborn child. Our research~     aims to find ways to control GWG by developing new and practical approaches to diet and~     exercise targeted to overweight pregnant women that hold promise of improving their health~     both during pregnancy and thereafter. The experimental intervention is a diet of higher~     protein provided by dairy foods combined with an exercise program modified to the abilities~     of overweight pregnant women; and the control is the usual advice given by their primary~     care providers, information on healthy pregnancy from Health Canada, and a focus group~     session exploring women's experiences with exercise, nutrition, and gestational weight gain.~     The results of this study will allow us to design future large clinical studies in all~     pregnant women to help control the weight gain in all pregnant women.~   "
104176|NCT01693497|"~     This study aims to compare two active psychological treatments for PTSD. One is an~     established therapy, Cognitive Processing Therapy (CPT) which operates as a control~     condition for a newly developed intervention, an integrative Gestalt-based trauma therapy,~     Dialogical Exposure Therapy (DET). There is no inactive control condition. We expect the two~     therapies to perform on a similar level, which would constitute evidence for the efficacy of~     DET.~   "
104191|NCT01693302|"~     Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due~     to the delayed action of insulin when compared to carbohydrate absorption from food. It is~     the hypothesis of the investigator that administering the insulin for a meal 20 minutes~     before the meal will result in lower blood glucose peaks compared to administration of~     insulin immediately before or 20 minutes after starting to eat.~      All subjects will eat the same meal on three different occasions. Insulin will be~     administered at one of the three times at each visit.~   "
104192|NCT01693289|"~     the study compare the hormonal-metabolic and reproductive outcome between combined~     metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic~     syndrome~   "
105969|NCT01670110|"~     The purpose of this study is to compare SOM230 treatment to placebo. The investigators will~     also assess the efficacy and safety of SOM230 in reducing total liver volume and improving~     quality of life.~   "
104177|NCT01693484|"~     Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to~     learn if patterns of blood-flow around the incision site of patients undergoing surgery for~     heel-bone fractures can help predict whether complications will arise after a specific type~     of operation.The goals of this research study are to effectively answer as many of the~     following research questions as possible:~        1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue~          transfer be used to identify altered patterns of blood flow at the operative site of~          Calcaneus fractures, when compared to the uninjured extremity?~        2. Are changes in blood flow identifiable at the operative site post operatively?~        3. Are there certain patterns of blood flow present preoperatively or postoperatively that~          can predict wound complication?~        4. Can certain patterns of blood flow predict the location of slough or dehiscence after~          surgery?~        5. Does the incision site and its proximity to specific patterns of blood flow possibly~          predict wound complication?~      The hypothesis is that the study drug will show a correlation between certain patterns of~     blood flow and whatever post-operative complications may arise.~   "
104178|NCT01693471|"~     The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting~     from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients~     whose control levels are partly controlled or uncontrolled.~   "
104179|NCT01693458|"~     The Appreciative Inquiry Change Agents (CA) program (NAMWEZA) intends to address broad~     societal issues by engaging HIV-positive leaders as 'change agents' in their communities. In~     this study, the CAs will be recruited from an HIV Care and Treatment Centre in Dar es~     Salaam. The Namweza program has the potential to address structural issues related to HIV~     risk, such as access to limited resources, through an entrepreneurial component of the~     program. A positive, or appreciative, focus promotes CAs to examine assets in themselves and~     in their networks, encourages strengthening of relationships, and facilitates planning for a~     positive future for themselves, their families, and their communities.~      A stepped wedge randomized trial will be performed to evaluate the effectiveness of the~     program for the following primary outcomes: uptake of HIV services among network members of~     the CAs; rate of unprotected sex and frequency of concurrent relationships among CAs and~     their social networks; and levels of self-esteem, general self efficacy, and risk of~     intimate partner violence in the CAs. Secondary outcomes include: depressive symptoms,~     hopefulness, and HIV-related stigma (among CAs); social support and quality of relationships~     (among CAs); and HIV knowledge, attitudes and self-efficacy in preventing HIV transmission~     or re-infection (CAs and their networks).~      The following are primary hypotheses that will be tested through this stepped wedge~     randomized trial evaluation:~        1. Uptake of HIV services will increase among individuals in the network of the~          HIV-positive Change Agents related to the intervention;~        2. Levels of self-esteem and general self-efficacy will increase in trained Change Agents;~        3. Rate of unprotected sex and number of concurrent partners will decrease (among network~          of Change Agents as well as Change Agents themselves; i.e. the 'study population'); and~        4. Prevalence of intimate partner violence (IPV) will decrease in Change Agents.~           Secondary hypotheses are:~        5. Prevalence of depressive symptoms and HIV-related stigma will decrease and level of~          hopefulness will increase in trained Change Agents;~        6. Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and~          re-infection among CA and their networks will increase; and~        7. Degree of social support and quality of relationships will improve among CA.~      If the proposed intervention is found to be effective, linkages with the Tanzanian Ministry~     of Health and other stakeholders will enable scale-up of the program throughout the country.~   "
104180|NCT01693445|"~     This study will attempt to determine the feasibility of combination of Oxaliplatin,~     Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents~     used, and to preliminarily evaluate the antitumor activity in untreated patients with~     advanced gastrointestinal cancer.~   "
104181|NCT01693432|"~     This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in~     Korean patients with esophageal cancer.~   "
104182|NCT01693419|"~     This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line~     chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression,~     KRAS mutation, and BRAF mutation as predictive or prognostic markers~   "
104183|NCT01693406|"~     Childhood obesity is a critical global public health concern. Breastfeeding is the ideal~     choice for infant nutrition. However, rapid and excess weight gain during infancy predicts~     later, even among breastfed infants. This risk is higher if mothers are obese and/or~     diabetic. Composition of bioactive components of breast milk may differ based between~     mothers who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2~     Diabetes are associated with overall increases in inflammation and oxidative stress, but how~     breast milk composition is affected remains unknown. Our overarching goal is to determine~     how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how~     differences in composition may impact infant growth and fat development. We are undertaking~     a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2~     Diabetic mothers and their infants over the first 4 months of life. We will track infant~     weight and fat gain and monitor maternal glucose control. We will also collect breast milk~     samples over the first 4 months and measure concentrations of growth and appetite hormones,~     cytokines, markers of oxidative stress and nutrient composition in milk. We predict that~     concentrations of growth-regulatory hormones (insulin and leptin) in addition to the~     inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from NW~     mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in~     Type 2 Diabetic mothers' breast milk. We expect these differences will be most pronounced in~     the first 2 weeks after birth. We also predict that breast milk concentrations of these~     biomarkers will be associated with infant fat gain. What we find will help us understand how~     early infant nutrition and growth may affect that child's later risk of obesity.~   "
104184|NCT01693393|"~     Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary~     Sjögren Syndrome~   "
104185|NCT01693380|"~     Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated~     household members.~   "
104186|NCT01693367|"~     The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS)~     used to stabilize the shaft component of distal femur fractures in comparison to standard~     locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes~     (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.~   "
104187|NCT01693354|"~     The purpose of this study is to determine whether mid-dilution hemodiafiltration is~     effective in the reduction of the crude mortality risk in patients who have been undergoing~     renal replacement treatment for less than 1 year. Patients will be randomized since the~     beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.~   "
104188|NCT01693341|"~     To examine the feasibility of improving stroke patients' physical functional recovery and~     social participation through improving caregiver's care capability.~   "
104189|NCT01693328|"~     National multicenter, prospective, observational study in cancer patients with chronic~     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic~     condition by a specialist in the treatment of cancer pain conditions.~      • Study objectives include assessment of early treatment satisfaction.~   "
104190|NCT01693315|"~     The objective of this dose-escalation study is to evaluate the safety, tolerability and~     efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular~     hypertension or primary open-angle glaucoma.~   "
104193|NCT01693276|"~     This study will analyze the effects, good and/or bad, of the drug Abraxane in combination~     with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally~     advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in~     this study are FDA-approved for use in patients with pancreatic cancer.~   "
104194|NCT01693263|"~     Dialysis access, which is the connection that allows blood to flow in and out of the body~     during dialysis sessions, is important to remove wastes and excess fluid for patients with~     end stage renal disease (ESRD). One method used to access the vein and artery for dialysis~     is called a brachiocephalic fistula. Patients are being asked to participate in this study~     because they have endstage renal disease, and their doctor has recommended that they will~     have brachiocephalic fistula placed for their dialysis access.~      A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch~     stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS~     causes problems with the opening of the veins and arteries needed for dialysis. Once someone~     suffers CAS they may need several radiology procedures as well as surgery to help correct~     the problem.~      The BCF may fail once CAS develops.~      The purpose of the research study is to gather information about the BCF and what is~     happening inside the vein. The researchers hope to find out what may be the cause of CAS.~   "
104195|NCT01693250|"~     The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the~     increased prevalence of childhood obesity in the last two decades. Obesity during the~     adolescent years is associated with many adverse health consequences, including T2DM,~     hyperlipidemia, and psychosocial problems. The first step toward effective obesity~     management and T2DM prevention is monitoring of physical activity (PA) and dietary intake.~     With the rapid expansion of cellular networks, and advancements in smartphone technologies,~     it is now possible to monitor PA and dietary intake and at the same time to transmit data~     digitally to their primary care providers (PCP). The proposed pilot study will include the~     collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight~     and/or obese adolescents. The study will adapt and implement smartphone-based technologies~     and integrate these technologies with the Electronic Health Record (EHR) to increase PA and~     dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra~     applications for the smartphone-based technologies and EHR and (2) and assess the~     feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity,~     dietary intake, BMI, and lipid profile), at 3 months post intervention between the~     intervention and control groups. The smartphone app for the intervention group will allow~     the teens to graphically compare daily PA and dietary intake with the goal, participate in a~     reward program where they can collect virtual points for achieving the goal, and play~     interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents~     at NEMS will be recruited and randomized to the feasibility study (Aim 2). Findings from~     this study will be used to plan for a NIH R01.~   "
104196|NCT01693237|"~     The current trial aims to investigate the impact of continuous feedback on dropout and~     outcome in group therapy. The hypothesis is that continuous feedback to patient and~     therapist on treatment progress and alliance will 1) increase adherence and 2) increase~     treatment outcome.~   "
104197|NCT01693224|"~     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational~     performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting~     tuberculosis in HIV-infected adults.~      A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid~     Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.~   "
104198|NCT01693211|"~     This is a prospective, randomized study evaluating the circularity of the anterior~     capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual~     capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed~     with cataract, scheduled to undergo removal by phacoemulsification with intraocular lens~     implantation in SNEC.~      The primary study end point is to determine if the circularity of the created rhexis is~     better in Group A as compared to Group B.~      The secondary study end point is to determine the diameter of rhexis is more precise and~     reproducible in Group A as compared to Group B.~   "
104199|NCT01693198|"~     People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness ,~     sneezing and itching .Typically, it happens during or immediately after contact with the~     lake`s water . The symptoms are compatible with immediate allergic reaction. Previous~     reports suggested a connection between similar symptoms and contact with different~     cyanobacteria (living in fresh water lakes). In this study we intend to prove the mechanism~     of these reactions. To prove the exact allergen that causes allergic rhinitis allergists~     perform skin tests with different suspected allergens. Likewise, we would like to perform~     skin tests to different proteins extracted from cyanobacteria collected in lake Kineret.~   "
104200|NCT01693185|"~     The aim of the present study is to compare patient's recovery times after elective~     colonoscopy employing remifentanil only vs conventional combination of midazolam and~     meperidine~   "
104201|NCT01693172|"~     The aim of this study is to evaluate the effect of an early postoperative physical~     rehabilitation program on the functional capacity and incidence of postoperative~     complications in patients undergoing major elective surgery for treatment of a neoplasm~   "
104202|NCT01693159|"~     The SUPPORT trial is an open-label, prospective, randomized, national multicenter~     intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the~     standard treatment of each institution on the pain intensity and QoL in patients with~     locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades~     during radioimmunotherapy.~   "
104203|NCT01693146|"~     Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and~     hypercapnia.~      Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD~     patients with hypercapnia.~   "
104204|NCT01693133|"~     The objective of this study is to evaluate the percentage of patients with complete diabetic~     foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human~     amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.~   "
104205|NCT01693120|"~     VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded,~     investigational clinical study. The purpose of this clinical study is to evaluate the risk~     of procedure and/or device related strokes in subjects with persistent or long-standing~     persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.~   "
104219|NCT01692925|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog~     alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.~   "
104206|NCT01693107|"~     This study will be divided into two phases. The purpose of the Phase I registry is to assess~     the current force being used for ablation of symptomatic paroxysmal AF in a wide range of~     operators in different Canadian centres with the operators being blinded to the contact~     force data.~      In Phase II of the study, operators will have open use of the force contact data. Phase I~     and II data will be compared in order to assess the efficiency of using the THERMOCOOL®~     SMARTTOUCH™ catheter.~   "
104207|NCT01693094|"~     The investigators plan a prospective randomized controlled study that compares the treatment~     decisions made by patients who receive decision aids, as compared to patients treated with~     usual care and the American Society for Surgery of the Hand brochures. The investigators~     expect to enroll 126 patients.~   "
104208|NCT01693081|"~     'Off periods' where people with Parkinson's disease are slow, stiff and unable to function~     are disabling, and a treatment which can converts people to a on, good, able to function~     state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled~     dry powder apomorphine (VR040) in a clinic-based study in this setting.~   "
104209|NCT01693068|"~     This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib~     versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated~     subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by~     comparing the progression-free survival (PFS) of subjects treated with either pimasertib or~     dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics~     (PGx) and their relationship with pimasertib exposure.~   "
104210|NCT01693055|"~     Study title~        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design~        -  single arm and Investigator Initiative pilot study~   "
104211|NCT01693042|"~     Single or repeated application of autologous bone marrow-derived stem cells to treat chronic~     post-infarction heart failure~   "
104212|NCT01693029|"~     The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US~     licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is~     intended to generate data supporting that the efficacy and safety under treatment with HX575~     and Epogen®/Procrit® are comparable.~   "
104213|NCT01693016|"~     The purpose of this study is to evaluate the value of the new technique of non-invasive~     measurement of Hb in children undergoing a surgical procedure.~   "
104214|NCT01693003|"~     Exercise intolerance is a major complain of patients with chronic obstructive pulmonary~     disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor~     responsible for the appearance of intolerable dyspnea during exercise. Regular treatment~     with long-acting bronchodilators promotes a more sustained reduction of hyperinflation and~     consequent symptom relief and increase in the patient's ability to overcome physical demands~     of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic~     bronchodilator that significantly improves lung function, reduces symptoms and improves~     exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration~     (>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily~     administration. Compared to tiotropium, indacaterol provides evidence that is as effective~     as tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and~     state of health. However, comparative effects of indacaterol versus tiotropium with regard~     to outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce.~     We hypothesized that indacaterol and TIO are not different in terms of exercise tolerance~     and its determinants (dynamic hyperinflation and dyspnea).~   "
104215|NCT01692990|"~     20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of~     0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they~     were given a standard breakfast and asked to report their appetite on visual analogue scales~     (VAS) immediately before and after the meal. The results were analyzed in accordance with~     the paired design under consideration of both supplement sequence and gender.~   "
104216|NCT01692977|"~     The disruption of spatial orientation is considered the second most common cognitive symptom~     of dementia, affecting nearly all activities of daily living. Research in the field of~     environmental psychology has helped to highlight the influence of the environment on~     patients with Alzheimer's disease or related syndromes. With regard to spatial orientation,~     it has been shown that an environment can provide support for cognitive failures in subjects~     if that particular space is adapted. While numerous studies have focused on the~     architectural environment (hospital, housing facility), none have explored the ability of~     patients to orient themselves in a natural environment such as a garden. Yet, in recent~     years, such gardens, known as healing gardens, have emerged in housing and care facilities,~     providing genuine support for the care management of patients with Alzheimer-type dementia.~     Various works have been published outlining recommendations for their management. However,~     with regard to spatial orientation, none of the available research has explored the basic~     principles on which to rely on in order to organize the elements of outdoor spaces into~     itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence~     of such data, these authors recommend relying on five elements, identified by Lynch in his~     landmark book Image of the City (1960), that people use to orient themselves and find~     their way. These are  paths ,  edges ,  districts ,  nodes  and  landmarks . The~     hypothesis to verify is that patients with Alzheimer's disease do not rely on the same~     elements of the garden as non-Alzheimer's subjects in making orientation decisions and to~     mentally picture this environment.~   "
104217|NCT01692951|"~     Surgical removal of tumor at an early stage remains the primary treatment for most cancers.~     However, there is currently no reliable screening blood test for detection of lung, colon,~     or breast cancer. The Specific Aims are to: 1) assess the diagnostic accuracy of six FFA~     metabolites to detect lung and colon cancer in surgical patients; 2)determine the rate and~     extent to which FFA metabolites decrease over time after surgery for lung and colon cancer;~     and, 3)determine the positive and negative predictive values and overall test accuracy for~     diagnostic prostate and breast biopsies.~   "
104218|NCT01692938|"~     To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.~     The study will assess variability across measurements taken by three different~     operator-device configuration across clinical sites, variability between subjects within a~     given operator-device configuration, and variability within a subject for a single~     operator-device configuration.~   "
104222|NCT01692886|"~     This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal~     serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when~     measured 1 month after the infant series, and to evaluate the acceptability of the safety~     profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and~     adverse events.~   "
104223|NCT01692873|"~     Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.~      Most patients present at diagnosis a non resectable, locally advanced or metastatic disease,~     with a median survival of 12 month.~      The aim of this study is the identification of diagnosis biomarkers, predictive of the~     therapeutic response.~      This project investigate the use of molecular analyses applied to pancreatic tumor cells~     collected by microbiopsy under ultrasound-endoscopy, and blood cells.~   "
104224|NCT01692860|"~     . The purpose of this study is to examine the effects of eating a larger amount of~     dairy-based protein on risk factors for metabolic syndrome~   "
104225|NCT01692847|"~     A hospitals manual method of patient monitoring will be implemented in an automated system~     and supported by an early patient deterioration detection for timely escalation. The purpose~     of this study is to assess if clinical outcomes of patients in Acute Care are significantly~     improved by such a system.~   "
104226|NCT01692834|"~     To compare the bioavailability, pharmacokinetic profiles and the tolerability of two~     formulations of intravenous cyclosporine in healthy volunteers.~   "
104227|NCT01692821|"~     Adequate perfusion and oxygenation is essential for the function of the inner retina.~     Although it is known that oxygen tension is very well autoregulated in the retina, the~     physiological mechanisms behind this regulation process are not fully explored. The~     development of new instruments for the non-invasive measurement of oxygen tension in retinal~     vessels now allows for the more precise investigation of these physiological processes. The~     current study seeks to evaluate the retinal oxygen saturation in healthy subjects while~     breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.~   "
104228|NCT01692808|"~     The purpose of this study is to determine if high doses of vitamin D3 administered orally as~     adjunct therapy to children with Crohn's disease could improve the outcome of the disease.~   "
104229|NCT01692795|"~     Large randomised trials have shown that cardiovascular medications prescribed to patients at~     high cardiovascular risk are effective in reducing the incidence of cardiovascular events.~     Their use is recommended in the United Kingdom and international guidelines (e.g. the~     National Institute of Clinical Excellence). However, these medications do not prevent~     cardiovascular events in all patients and there is now a body of research investigating the~     effects of cardiovascular medications on outcomes in myocardial infarction (MI), including~     clinical presentation, infarct size and post-MI mortality. However, the independent effects~     of cardiovascular drugs on post-MI all cause mortality are unclear, and there are~     limitations to many of the published studies in terms of their cardiovascular drug exposure~     data. This project utilizes prospectively collected data on cardiovascular drug use, and~     links to MI data from hospital and mortality records.~   "
104230|NCT01692782|"~     A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder~     (ADHD).~   "
104231|NCT01692769|"~     Background: Trauma is a major cause of death in children and teenagers. When young patients~     have suffered major traumatic injuries, they require intravenous (iv) fluids to keep their~     blood vessels full and ensure blood flow to vital organs. Current fluid guidelines by~     International Trauma Committees recommend either Normal Saline (NS) or Ringer's Lactate (RL)~     as the fluid of choice for these patients. Although these solutions share some similarities~     in their composition, there are also some significant differences in sodium, chloride and~     lactate concentrations. Despite these differences in fluid composition, there has never been~     a study comparing these two fluids in paediatric trauma patients to determine which is~     optimal. In this study, the investigators aim to determine the optimal fluid choice for~     trauma resuscitation of young patients.~      Hypothesis: The investigators hypothesize that severely injured paediatric trauma patients~     resuscitated with NS will have optimal blood sodium levels compared to patients resuscitated~     with RL.~      Methods: The investigators will study 50 paediatric trauma patients that will be randomized~     so that half will randomly receive NS and half will receive RL as their only iv fluid for 24~     hours. After 24 hours, the investigators will compare in blood the sodium level, the amount~     of acid, and the concentrations of inflammation molecules in relation to those whom received~     NS versus RL.~      Expected Results and Significance: Maintaining optimal levels of these biochemical markers~     is imperative in reducing morbidity and mortality in severely injured paediatric patients.~     If significant differences are present, the investigators will be able to determine which~     fluid is preferred and expect these data to complement current trauma resuscitation~     guidelines.~   "
104232|NCT01692756|"~     This research study is the first of its kind and will allow health care professionals and~     researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)~     injury leads to knee pain and disability and osteoarthritis. We also hope that this study~     will be the beginning of new, more powerful and safer drugs to help patients with ACL~     injuries heal sooner and return to sports or daily activities pain free. Study participants~     will be recruited from the University of Kentucky and Vanderbilt University.~      The purpose of this research is to gather information on how safe and effective Kenalog® is~     in alleviating knee pain following ACL rupture.~   "
104233|NCT01692743|"~     Improved methods are needed to monitor patients with inflammatory bowel disease.~     Telemedicine has shown promise in patients with other chronic diseases; pilot testing in our~     patients with inflammatory bowel disease demonstrated that the technology was feasible and~     improved clinical outcomes.~      The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should~     improve outcomes for patients, improve access to care in areas with limited resources, and~     decrease health care costs.~   "
104254|NCT01692470|"~     The purpose of this study is to assess the safety and effectiveness of rilpivirine~     hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment~     of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human~     immunodeficiency virus type 1 (HIV-1) infection.~   "
104255|NCT01692457|"~     The purpose of this study is to assess the safety and effectiveness of golimumab for the~     treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among~     Filipino patients.~   "
104234|NCT01692730|"~     This trial will test the effectiveness of an enhanced web-based smoking cessation~     intervention for student smokers at 2-year Community Colleges. Young adults continue to be~     understudied, so more studies of cessation interventions are needed to generate an~     acceptable level of strength of evidence regarding quit rates, particularly so for Community~     College students for whom little data on cessation are available. Students (research~     subjects) will be directed to one of two intervention websites with various levels of novel~     interactive and social network features, including a variety of better-practice features~     recommended by recent literature, and technologically advanced proactive features (e-mails,~     SMS texting, and social networking).~      Our study hypothesizes that students with access to an enhanced website will have higher~     rates of self-reported intention to quit, a higher number of quit attempts at 6-months~     compared to those in in a non-enhanced website. Overall, this study will evaluate evidence~     for a novel enhanced cessation intervention model and will add to our understanding of~     successful intervention with an understudied population of primarily young adult Community~     College smokers. The intervention components will be replicable and, if effective, the~     methodology is applicable across populations, and has the potential for broad public health~     impact through improved delivery of effective stop smoking interventions via the internet.~   "
104235|NCT01692717|"~     The objective of this clinical study, randomized, crossover is to evaluate the~     pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)~     Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and~     Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum~     concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.~   "
104236|NCT01692704|"~     An open label, prospective, non-randomized single arm study. Combination of two treatment~     modalities - HAI with FUDR and systemic chemotherapy with cisplatin and gemcitabine.~      Definition of the maximum tolerated dose (MTD) of intravenous gemcitabine in combination~     with intravenous cisplatin and intra-arterial FUDR. Definition of safety and toxicity of~     this combined regional and systemic treatment approach. Definition of the response rate~     after 3 months of hepatic intra-arterial chemotherapy with continuous infusion FUDR with or~     without ligation of the right or left portal vein, in combination with 3 months of systemic~     cisplatin and gemcitabine in patients with unresectable intrahepatic or hilar CCC.~      A total of 9-18 patients are required. 3-6 patients per dose level. A maximum of three dose~     levels (1 - 3) has been defined.~      Statistical Methodology: Traditional 3+3 dosing algorithm to find MTD.~        -  Trial with medicinal product~   "
104237|NCT01692691|"~     The purpose of this study is to determine whether dacarbazine and carmustine at the doses~     and schedule used in this study will help to increase tumor shrinkage.~   "
104238|NCT01692678|"~     The purpose of this study is to find the optimal dose of trabectedin for Chinese patients~     with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were~     previously treated (in any order) with at least an anthracycline and ifosfamide containing~     regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy~     regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group~     is superior to dacarbazine group (Part 2).~   "
104239|NCT01692665|"~     Ocular aberration may play a role in determining optical quality. Recently performed study~     reported that ocular aberration of preocular tear film would be important factor in not only~     diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this~     study, the investigators will aim to prove the improvement of quality of vision via ocular~     aberration changes indirectly after the proper treatment for moderate and severe meibomian~     gland dysfunction. Also, the investigators will evaluate the changes of keratometric values~     after treatment for moderate and severe meibomian gland dysfunction, which could be~     demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.~   "
104240|NCT01692652|"~     Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative~     dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular~     symptoms, which are all associated with the constant release of inflammatory mediators. To~     our knowledge, there has been no study on tear cytokine levels in MGD patients treated with~     topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear~     cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical~     loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine~     the concentration of inflammatory tear cytokines in patients with MGD and to compare the~     changes in tear cytokine levels between topical loteprednol etabonate and warm compress~     treatment group and warm compress only treatment group.~   "
104241|NCT01692639|"~     Acetaminophen is the first drug involved in voluntary drug poisoning. According to the~     studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver~     failure, and this poisoning is responsible of 10 percent of liver transplants each year in~     these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk~     factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly~     correlated with factors predisposing socio-economic field are an important issue, including~     the speed and appropriateness of care are key factors both in terms of reducing morbidity~     mortality in socio-economic terms for the community.A nomogram defines a statistical~     threshold from which the blood concentration of paracetamol has a significant risk of liver~     toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a~     toxic dose, but there is no consensus on whether or not to repeat this dosage during the~     treatment, as the first result is beyond the threshold or not.The administration of the~     antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a~     protocol that can vary in different services.In the absence of clear guidelines, the~     question of the need for iterative dosages of paracetamol blood beyond the fourth hour~     post-ingestion if the initial paracetamol blood measurement is below the curve nomogram~     remains open.Is it possible to limit blood tests to a single assay paracétamolémie to H4~     when it is below the curve, and thus enable the return home of the patient's somatic point~     of view (excluding psychiatric care when is voluntary drug intoxication), with consequences~     in terms of costs (hospital days) and duration of treatment?~   "
104266|NCT01692314|"~     The purpose of this study is to investigate the effect os resistance training on~     microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart~     rate, body composition and physical fitness in obese adolescents.~   "
104242|NCT01692626|"~     When cancer patients are treated with the drug cetuximab they very often develop a rash.~     Usually it appears on their face and back and other parts of the body. The rash looks like~     acne and is treated with skin creams or antibiotics most of the time. The rash can become~     very painful and cause patients to stop using cetuximab to treat their cancer, even if~     cetuximab was helping fight their cancer.~      Cetuximab is known to be a good drug to help treat cancer. This study will help us learn~     about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for~     their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel)~     to see if it will help prevent the rash or keep the rash from getting worse. The~     investigators also want to see how the rash affects patients and their quality of life.~      Participants will be in this study for about four weeks if their rash does not get worse.~     They will need to apply the study cream and placebo two times daily and answer quality of~     life questionnaires during this study. Participants will also be seen by a dermatologist and~     have pictures taken of their rash.~   "
104243|NCT01692613|"~     Background:~      The immediate endoscopic identification and diagnosis of intraepithelial structures and~     immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet~     goals in the diagnosis and management of subjects with food intolerances, who are negative~     to all available tests. Endomicroscopy may be helpful to further visualize and characterize~     unmasked small bowel reactions to foods, which has not been described before.~      Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the~     macroscopic view ,which enables the examiner to see immediate reactions after exposure and~     it further allows capturing of fluid excreted by the gut for further analysis to understand~     the pathology behind this reaction further.~      N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and~     negative testing with routine methods. Patients with Lactose intolerance n=10 patients to~     compare results. Patients with Fructose intolerance n=10 patients to compare results.~     Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the~     Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain~     (n=10) to serve as healthy controls for allergy testing.~      Methods:~      The primary objective is to investigate whether endomicroscopy will allow the detection of~     an allergic reaction of the gut after exposure of the 5 major allergens in the following~     way:~      After standard gastroscopy with the endomicroscope including evaluation of the surface of~     the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation~     of the duodenal surface including count of initial lymphocytes/mononuclear cells in the~     lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple),~     allergen 5 (yeast).~      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in~     the lamina propria of the duodenum, representing an acute reaction to one of the allergens~     sprayed to its surface through the endoscope channel.~   "
104244|NCT01692600|"~     Radiation therapy of the head and neck cancer patients causes late oral radiation~     complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as~     hyperbaric oxygen are used to treat these complications; however, there are no quantifiable~     means of assessing the outcome of these methods. At present, subjective methods such as~     superficial examination of the oral cavity are used, yet complications are known to mostly~     start in the subsurface layers. In this feasibility study, we apply an imaging technique~     called optical coherence tomography (OCT) as a means of providing objective and quantifiable~     images of the subsurface micro-structural and micro-vascular changes of oral tissue.~     Depth-resolved, micrometer-resolution OCT images provide information on changes associated~     with late radiation complications.~   "
104245|NCT01692587|"~     The Purpose of the Protein Study is to investigate whether a reduced protein diet can~     inhibit the growth of prostate cancer in humans.~      The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes~     that are involved in the growth of prostate cancer.~   "
104246|NCT01692574|"~     To determine whether individuals who suffer from depression and obesity are able to lose~     weight and show improvements in mood and cardiovascular disease risk factors following 20~     weeks of a combined treatment of cognitive-behavior therapy for depression and behavior~     modification for weight loss. Participants will be assigned to one of three treatments: 1)~     cognitive-behavior therapy for the treatment of depression combined with an alternative~     approach to weight loss, 2) a weight loss intervention combined with a depression support~     and education , or 3) cognitive-behavioral therapy for depression combined with a weight~     loss intervention.~   "
104247|NCT01692561|"~     The purpose of this research study is to better understand what causes dysautonomia and how~     this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous~     system. It is associated with fluctuations in blood pressure and pulse and may cause~     symptoms of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness,~     feelings of anxiety or panic, and fainting. A common example of dysautonomia is postural~     orthostatic tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from~     lying down to standing, called orthostatic intolerance. We would like to learn more about~     the link between orthostatic intolerance and nausea. While medications currently used to~     treat orthostatic intolerance and nausea have proven to be effective in some patients, this~     may not be the best treatment for everyone as long term use could pose certain risks~     including high blood pressure. In order to provide a more focused and safer treatment for~     patients suffering from nausea and orthostatic intolerance, we have looked at how the blood~     pressure, pulse, and certain blood tests change during a tilt table test. This test helps to~     create the same circumstances that patients with orthostatic intolerance experience when~     they stand. To better understand if some of these problems are associated with the brain, we~     will study MRI in patients with dysautonomia compared to children without dysautonomia. This~     information may allow us to use alternative and safer treatments in the future.~   "
104248|NCT01692548|"~     Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a~     neurofeedback intervention or waiting list.~   "
104249|NCT01692535|"~     In this multicenter study the investigators are going to evaluate the use of six different~     videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with~     intubation. The investigators are hypothesizing that these six videolaryngoscopes will~     succeed for intubation at first attempt in at least 90% of all cases using a difficult~     airway simulation with extrication collars. As gold standard, a standard Macintosh blade is~     being used.~      The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720~     patients.~   "
104250|NCT01692522|"~     The investigators will evaluate the first attempt visualized blind intubation through an~     Ambu Aura-i versus an AirQ.~   "
104251|NCT01692509|"~     The practices and processes related to the administration of noninvasive ventilation (NIV)~     in the adult intensive care unit (ICU) of the University hospital of Lausanne will be~     recorded by an investigator at the bedside. The effect of the NIV treatment on various~     respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will~     also be recorded using a pneumotachograph. Finally patient's comfort during NIV treatment~     will be evaluated.~   "
104256|NCT01692444|"~     Airway remodelling is an abnormal tissue repair following bronchial inflammation, which~     contributes to none reversible pathological features, such as bronchial and peri-bronchial~     fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD)~     and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in~     the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the~     recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain~     unknown.~      The main objective of the study is to analyse the distribution and quantify the number of~     the peri-bronchial and blood circulating fibrocytes in patients with different stages of~     COPD compared to control subjects.~   "
104257|NCT01692431|"~     The primary aim of this study is to determine the impact of individual fish oil fatty acids~     on vascular reactivity and to identify underlying physiological and molecular mechanism of~     any observed effects. In addition response to intervention according to genotype will be~     determined retrospectively.~   "
104258|NCT01692418|"~     Anaemia is a common problem in patients undergoing surgery. About half of patients~     undergoing a major operation have anaemia, often a consequence of the disease requiring~     surgery. Anaemia causes patients to feel tired and unwell. Anaemia at the time of surgery~     increases the requirement for blood transfusion (50% if anaemic compared to only 15% without~     anaemia). Both anaemia and blood transfusions are associated with increased complications~     from surgery, delayed recovery and prolonged hospital stay. The investigators propose that~     giving intravenous iron before operation can be used to correct anaemia in these patients.~     Consequently if patients are not anaemic they are less likely to need blood transfusion.~     Also patients feel better and their health is improved before their operation they are more~     likely to tolerate the surgery, recover faster, be less likely to have complications from~     surgery and return home sooner. This will have benefits to the individual patient and also~     to the NHS by reducing costs.~      Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the~     tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50%~     of people continue taking oral iron. A full treatment dose of intravenous iron can be given~     in 15 minutes with minimal side effects. The effect is to rapidly increase blood counts in~     2-4 weeks. The investigators propose that this treatment can be incorporated to patient~     preparation pathways for surgery as an outpatient without the need for additional visits to~     hospital.~      Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological~     surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in~     the UK. The investigators anticipate half of patients treated will have their anaemia~     corrected before operation. Patients with anaemia will be identified as part of the routine~     blood tests taken preoperatively and invited to take part in the study. Following informed~     consent, they will be randomly allocated to receive either intravenous iron or a placebo~     infusion of saline. Intravenous iron is a dark liquid given continuously into a vein over 15~     minutes. To ensure neither doctor nor patient knows which treatment is being given both~     infusions will be prepared and administered by an unblinded authorised person via a black~     bag through black tubing. There will be no other changes to the patient's normal treatment.~      The main aim of this study is to assess if intravenous iron will reduce the need for blood~     transfusion in the time period around the operation. Further outcome measures will include;~     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes~     will be assessed both during hospital stay and after the patient has been discharged. The~     trial will be run through a Clinical Trials Unit with considerable experience in conducting~     large trials. The team has a large range of experience in anaemia management and assessment~     of complications, quality of life and the cost of health care.~      The main aim of this study is to assess if intravenous iron will reduce the need for blood~     transfusion in the time period around the operation. Further outcome measures will include;~     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes~     will be assessed both during hospital stay and after the patient has been discharged. The~     trial will be run through a Clinical Trials Unit with considerable experience in conducting~     large trials. The team has a large range of experience in anaemia management and assessment~     of complications, quality of life and the cost of health care.~   "
104259|NCT01692405|"~     Performance evaluation of a novel, semi-automated device and method for needle core biopsy~     download compared to standard methods in terms of:~        1. Biopsy core length obtained (i.e. collecting all tissue fragments)~        2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)~        3. Pathologist interpretability~        4. Processing time~        5. Prostate cancer detection.~   "
104260|NCT01692392|"~     The purpose of the study is to assess changes in health-related quality of life in patients~     undergoing surgical correction of pectus carinatum. In addition, the study assessed~     long-term effects of surgical intervention in relation to the development of persistent~     postoperative pain and / or sensory disturbances in the surgical field.~   "
104261|NCT01692379|"~     To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is~     superior to medical management alone in achieving favorable outcome in the distribution of~     the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel~     ischemic stroke < 8 hours from symptom onset.~   "
104262|NCT01692366|"~     Primary Objective:~      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and~     combined for the response rate defined with the ≥35% reduction of spleen volume as~     determined by magnetic resonance imaging (MRI or computed tomography scan [CT] in patients~     with contraindications for MRI).~      Secondary Objectives:~        -  To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and~          individual doses population.~        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose.~        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF).~        -  To evaluate the durability of splenic response.~        -  To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin~          fibrosis.~   "
104263|NCT01692353|"~     This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to~     compare selected CVD biomarker data between subjects who were long-term consumers of~     cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal~     endpoints related to CVD risk that differed among the three tobacco-use cohorts. The~     following assessments provided the primary study endpoints for comparative analyses between~     the cohorts:~        1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid~          intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired~          carbon monoxide (ECO).~        2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect).~        3. Biomarkers of tobacco exposure in urine and blood.~   "
104264|NCT01692340|"~     Tomatoes contain several compounds which may be beneficial for human health and prevention~     of disease, although this relationship is poorly understood and very controversial. This~     study uses a new technology to study the absorption and metabolism of three different~     compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and~     lycopene. We hypothesize that by studying the absorption and metabolism of these compounds,~     we may be able to understand how the compounds may influence health and disease processes.~   "
104265|NCT01692327|"~     The hypothesis of the proposed project is that after a fat overload, the postprandial~     response is different in both groups, suggesting that the LPP will present the most~     significant damage in endothelial vasomotion in obese individuals, especially those with GI~     and T2DM. After the fat overload, we hypothesized that there will be a worsening of~     endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but~     also find lower concentrations of incretins in OB/DM2 group compared to other groups.~      These hypotheses may be confirmed by techniques for evaluating microvascular function, the~     use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic~     and cardiovascular read by Multiplex kit.~   "
104267|NCT01692301|"~     The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central~     Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and~     arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and~     widened pulse pressure (PP).~   "
104268|NCT01692288|"~     The purpose of this study is to determine if children and mothers who participate in the~     First Born® Program (FBP) experience better outcomes than they would have in the absence of~     the program. The evaluation employs a randomized trial design to assess the effectiveness of~     the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses~     clinically trained professionals to provide first-time parents with information, training,~     and access to resources designed to promote early childhood development. Services are free~     and may begin at any time during pregnancy or up to two months after the baby's birth and~     may continue until the child is three years old. In addition, a nurse postpartum home visit~     is offered to the parents of all participating newborns. The FBP model builds on other home~     visiting and prevention programs that have been shown to improve long-term outcomes of~     children and their families.~   "
104269|NCT01692275|"~     The purpose of this study is to evaluate the effectiveness of chiropractic manipulative~     therapy for pain management and improved function in active duty service members with low~     back pain that do not require surgery. The study will also measure the impact of a tobacco~     cessation program delivered to participants allocated to the chiropractic arm.~   "
104270|NCT01692262|"~     To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy,~     in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated~     in patients who have progressed after chemotherapy (Part A) and in patients who have~     progressed before receiving chemotherapy (Part B).~      Recruitment into Part A, Group 1 has been suspended. A new design for this group is~     currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd~     generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days~     on/3days off).~      Part B will only start if there is evidence of anti-tumour activity along with AZD5363~     having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy~     patients on a dose and schedule selected from Part A.~   "
104271|NCT01692249|"~     To determine whether spa therapy has a beneficial effect on pain and disability in the~     management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized~     prospective clinical trial includes patients with shoulder pain due to chronic degenerative~     rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are~     randomized into two groups: immediate spa therapy (18 days of standardized treatment) and~     control (spa therapy delayed for 6 months). All patients continue usual treatments during~     the 6-month follow-up period. The main endpoint is the mean change in the DASH score at 6~     months. Secondary endpoints are the mean change in SF-36 components, treatments used, and~     tolerance. The effect size of spa therapy is calculated and the proportion of patients~     reaching minimal clinically important improvement (MCII) is compared between groups.~   "
104272|NCT01692236|"~     Background:~      - Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel~     function. These problems may add to some thinking and mood disorders found in people with~     HIV infection. Researchers want to evaluate HIV infected patients to see if blood vessel~     function contributes to thinking and mood disorders, such as early dementia and depression.~     To do so, they will compare study results between people with and people without HIV~     infection.~      Objectives:~        -  To compare the thickness of blood vessel walls between people with and without HIV~          infection.~        -  To study the relationship between blood vessel thickness and thinking and mood~          disorders.~      Eligibility:~        -  Individuals between 25 and 55 years of age who have HIV infection.~        -  Healthy individuals between 25 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have imaging studies of the brain and major blood vessels in the head~          and neck.~        -  Participants will also have neuropsychological testing. These tests will look at~          memory, learning and thinking ability, attention, and mood.~        -  Participants will have the option of coming back for repeat blood tests every six~          months and repeat imaging studies and neuropsychological tests every year, over 1- 4~          years period.~   "
104273|NCT01692223|"~     This study uses new methods called genome sequencing that allow the investigators to study~     part or all of a person's genome. The genome is the collection of all of a person's genes.~     Genes carry the instructions that our bodies need to develop and function. Genes are passed~     on from one generation to the next. Genome sequencing can study all of a person's genome~     (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the~     study, the investigators refer to all these research methods as 'genome sequencing'. Genome~     sequencing typically shows a large number of gene changes, known as variants. Some (but~     not all) of these genetic variants may be linked to increased risks of diseases other than~     cancer.~      The purpose of this study is to learn what kinds of genetic variants the patient wants to~     learn about from their genome.~   "
104274|NCT01692210|"~     The goal of this research study is to learn about how dexmedetomidine (a standard of care~     sedative) affects your immune system (your defenses against cancer) by measuring your white~     blood cell levels before and after surgery.~   "
104275|NCT01692197|"~     The goal of this clinical research study is to learn if E7070 in combination with~     idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with~     either AML or high-risk MDS that has relapsed. The safety of the drug combination will also~     be studied.~   "
104276|NCT01692184|"~     This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and~     pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to~     evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.~   "
104277|NCT01692171|"~     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics~     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following~     administration of single intravenous dose. The objective of this randomized, crossover,~     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T~     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by~     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and~     anti-FIIa), as surrogate markers for their circulating concentrations of the drug.~   "
104278|NCT01692158|"~     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics~     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following~     administration of single subcutaneous dose. The objective of this randomized, crossover,~     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T~     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by~     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and~     anti-FIIa), as surrogate markers for their circulating concentrations of the drug.~   "
104279|NCT01692145|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
104280|NCT01692132|"~     The purpose of this study is to determine the safety and effectiveness of prucalopride in~     the treatment of Filipino patients with chronic constipation whom prior laxatives fail to~     provide adequate relief.~   "
104281|NCT01692119|"~     The aim of the study is to investigate whether a continuous interdisciplinary intervention~     improves medication adherence and leads to a reduction of hospitalizations and mortality in~     elderly patients with chronic heart failure. The intervention, consisting of regular~     contacts with the local pharmacy and weekly dosing aids, aims to improve medication~     adherence and management.~   "
104282|NCT01692106|"~     This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia,~     there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher~     baseline pressure in the LES. The most widespread treatment for this disease and the one~     that has the best long term results involves cutting the muscle layers of the lower~     esophagus and on the neighbouring stomach without injurying the underlying mucosa or inner~     layer of the esophageal wall. This is done during a surgery through the abdomen either with~     a big incision or more recently with the keyhole technique. This surgery has various~     potential complications, one of which being making a hole through the mucosa or not~     extending the cut on the muscle long enough to obtain adequate relaxation of the sphincter.~     The per oral endoscopic myotomy (POEM) is a new intervention that is done also under general~     anesthesia in the operating room; however, it involves no skin incisions and all the~     procedure is done through a fiber optic camera. It involves making a cut in the inner layer~     of the esophagus and then with cautery cut the muscle fibers responsible of the blockage and~     finally closing the initial opening with clips. In this study we will investigate the~     feasibility of this intervention both from a technical aspect as well as a logistical~     perspective given the local operating room constraints.~   "
104283|NCT01692093|"~     The purpose of this study is to determine clinical efficacy and safety of KM110329 for~     Atopic dermatitis.~   "
104284|NCT01692080|"~     The primary objective of this study is to document the prevalence and associations between~     asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its~     surrounding regions.~      The secondary objective is to determine the impact of various educational interventions on~     child and caregiver knowledge of asthma.~   "
104285|NCT01692067|"~     The purpose of this study is to determine potential risk factors for physical and sexual~     assault in regular military women (as opposed to Reserve and National Guard). In addition,~     this study seeks to determine associations between service women's violence exposures and:~     current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and~     civilian healthcare.~   "
104286|NCT01692054|"~     The aim of the study is to improve the prognosis of the development of alcohol consumption~     by considering a variety of biological, psychological and social risk and protective~     factors. Therefore, young people who have been hospitalized due to acute alcohol~     intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of~     healthy or impaired psychosocial development. The study will also include a control group of~     young adults who were in hospital due to other medical conditions. The identification of~     relevant cases will be based on medical records of several children's hospitals. These~     records will be analysed with regard to potential predictors of developmental hazards and~     protective factors.~   "
104287|NCT01692041|"~     The trial aims to record possible effects of a supplementary treatment with ivy leaves dry~     extract on different lung function parameter, on bronchial hyperreactivity, on individual~     markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is,~     that the additional therapy might improve these parameters and might help to optimize asthma~     therapy.~   "
104288|NCT01692028|"~     Hypothesis: low vitamin D status is associated with increased insulin resistance and~     increased blood pressure.~      Approach: Multiple regression analysis of information extracted from a large database~     accumulated by a Canadian health foundation, specifically evaluating statistical~     associations between serum 25(OH)D levels and insulin responsiveness measures as well as~     blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.~   "
104289|NCT01692015|"~     Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this~     study is to provide data regarding the diet and nosebleed frequency using a questionnaire.~      This will be filled in by people with HHT.~      The questionnaire has been designed in paper format.~   "
104290|NCT01692002|"~     The aim of these studies is to firstly determine the pharmacokinetic profile of orally~     administered enteric coated sodium propionate. Subsequently, the most efficacious dose at~     improving glucose tolerance following an oral glucose challenge will be determined. The~     investigators will then determine the mechanism of action of propionate, whether it acts by~     altering beta cell function directly or by augmenting the incretin effect or both~   "
104291|NCT01691989|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar compared with placebo when added to a~     sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with~     type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or~     sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of~     150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26~     weeks.~   "
104300|NCT01691872|"~     This is an open-label, single centre, parallel group study to evaluate the safety and~     pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese~     subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also~     incorporated. This study is intended to facilitate inclusion of Japanese patients in the~     global phase III program for retigabine XR formulation.~   "
104292|NCT01691976|"~     MCI with ageing is thought in part to be related to reduced serum sex hormones which is~     well-recognised, especially in females, but poorly understood. International studies~     assessing hormone replacement therapy (HRT) to prevent/reduce MCI are ongoing. MCI leads to~     morbidity, reduced quality of life and substantial healthcare costs. The commonest~     therapeutically induced reduction in sex hormone level in men is treatment of prostate~     cancer (PCa). PCa is androgen dependent and androgen-deprivation therapy (ADT) suppressing~     testosterone to castrate levels is key therapy for advanced disease. About one million men~     worldwide have received ADT for PCa, mostly using luteinising hormone releasing-hormone~     agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps 4% of~     Caucasians may be castrated. MCI as a side-effect of castration in men remains poorly~     researched. This pilot study will quantify the extent of MCI in men receiving ADT with LHRHa~     and oestrogen to inform the design of a larger study to understand mechanisms, predict~     affected patients and determine ways of reducing MCI. Researching relationships of sex~     hormones and MCI should improve understanding and interventions for slowing/preventing MCI~     in PCa survivors. HRT in women slows MCI. Alternatives for ADT include parenteral oestrogen.~     The PATCH clinical trial comparing transdermal oestrogen with LHRHa offers an opportunity to~     assess oestrogen as preventative for male MCI. Functional magnetic resonance imaging (fMRI),~     quantitative electroencephalography (qEEG) and neuropsychological tests will be used to test~     this hypothesis.~   "
104293|NCT01691963|"~     Usually videolaryngoscopy using a videolaryngoscope with a classic Macintosh design is~     performed with the blade in the vallecula and the epiglottis elevated from the vocal cords~     indirectly, as in direct laryngoscopy. However, during an audit of videolaryngoscopic~     practice we noticed that, in obtaining the best view, clinicians frequently and~     inadvertently advanced the blade into the vallecula to get a better view, such that the~     epiglottis was downfolded and elevated directly from the vocal cords. However, a better view~     does not necessarily lead to higher intubation success.~      In this randomized, controlled trial, we want to determine the efficacy of~     videolaryngoscope-guided tracheal intubation using an alternative position for the blade in~     patients with normal airways.~   "
104294|NCT01691950|"~     This is an observational study, which aims to firstly develop a sensor-based objective~     mobility assessment. This will then be used to profile and compare the outcomes of patients~     who undergo amputation with those who have limb salvage surgery following a traumatic injury~     to their lower limb.~   "
104295|NCT01691937|"~     Patients often experience moderate to severe postoperative pain, especially during the first~     hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be~     used after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et~     al. 2005), but the analgesic effect can be limited and undesirable side effects may occur.~      A case report described that right thoracic paravertebral block reduced pain and analgesic~     requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural~     analgesia, thoracic paravertebral block probably carries a much lower risk of spinal~     haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist~     1998; Karmakar 2001).~      We therefore designed a prospective, randomized, subject and assessor blinded,~     parallel-group, placebo controlled study to test the hypothesis that continuous right~     thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after~     right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with~     sufentanil.~   "
104296|NCT01691924|"~     No clinical trials with PBF-509 in humans have been performed to date. Only preclinical~     studies have been done to assess the pharmacology and pharmacokinetics, the safety and the~     toxicological profile of the PBF-509.~      An initial testing of PBF-509 in humans is planned, starting with the first-into-man~     clinical trial where a single oral, dose-escalating, and placebo-controlled design will be~     implemented.~   "
104297|NCT01691911|"~     Major vascular surgery involves operations to repair swollen blood vessels, clear debris~     from blocked arteries or bypass blocked blood vessels. Patients with these problems are a~     high-risk surgical group as they have generalized blood vessel disease. These puts them at~     risk of major complications around the time of surgery such as heart attacks , strokes and~     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in~     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple~     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote~     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply~     to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a~     further five minutes. This cycle is repeated three more times. The blood supply is~     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated~     brief interruption of the muscular blood supply sends signals to critical organs such as the~     brain and heart, which are rendered temporarily resistant to damage from reduced blood~     supply. Several small randomized clinical trials in patients undergoing different types of~     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial~     aims to determine whether RIPC can reduce complications in routine practice.~   "
104298|NCT01691898|"~     This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab~     vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX),~     as well as a combination of polatuzumab vedotin with obinutuzumab in participants with~     relapsed or refractory follicular non-Hodgkin's lymphoma (NHL) and relapsed/refractory~     diffuse large B-cell lymphoma (DLBCL).~   "
104299|NCT01691885|"~     The primary objective of the study is to test the hypothesis that lung hyperinflation~     contributes to cardiac dysfunction in COPD and that the treatment of lung deflation with~     FF/VI Inhalation Powder 100/25 mcg administered once daily (QD) will result in the reversal~     of this cardiac dysfunction compared with placebo. This will be assessed by measures of~     right and left global and regional systolic and diastolic cardiac function as assessed using~     a 30 minute CMR.~      A secondary objective will be to investigate the effect of FF/VI inhalation powder 100/25mcg~     QD on measures of arterial stiffness in the form of pulse wave analysis and distensability~     in the pulmonary and systemic circulation.~   "
104301|NCT01691859|"~     This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab~     administered subcutaneously (SC) in addition to standard of care in subjects who~     participated in the MEA112997 study. At each clinic visit, adverse events will be assessed~     and exacerbations will also be reviewed.~   "
104302|NCT01691846|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared~     with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately~     controlled with metformin monotherapy. Patients will be randomized to receive oral doses of~     150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26~     weeks.~   "
104303|NCT01691833|"~     The purpose of the study is to determine whether vitamin D supplementation in patients with~     hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with~     fractures of the humerus, femur, or tibia. The central hypothesis of the study is that~     vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the~     risk of nonunion compared to placebo treatment.~   "
104304|NCT01691820|"~     The purpose of this study is to estimate the incidence of CMV secondary infections~     (re-infections/re-activations) and the incidence of CMV primary infections in adolescent~     females.~   "
104305|NCT01691807|"~     The purpose of this study is to evaluate the potential drug-drug interactions between~     ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent~     B-cell non-Hodgkin's lymphoma (NHL).~   "
104306|NCT01691794|"~     The purpose of this study is to collect safety clinical data in HIV-infected pediatric~     patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are~     receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse~     transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.~   "
104307|NCT01691781|"~     This study will evaluate whether commonly used blood pressure medications called ACE~     inhibitors can lower parathyroid hormone.~   "
104308|NCT01691768|"~     The purpose of this study is to assess the effectiveness of an implementation model which~     integrates tenofovir gel provision into existing family planning services.~   "
104309|NCT01691755|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in~     patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic~     therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily~     or placebo. The anticipated time on study treatment is 26 weeks.~   "
104310|NCT01691742|"~     A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate~     postoperative period following pelvic reconstructive surgery in women taking routine~     docusate sodium.~      B. Objectives~        1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between~          MiraLAX versus placebo in women receiving routine docusate sodium after pelvic~          reconstructive surgery.~           Specific Aim 2: To compare patient reported outcomes of BM quality and associated~          gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool~          scale and the validated Patient Assessment of Constipation Symptom Questionnaire~          (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive~          surgery.~           Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo~          utilizing the validated Patient Assessment of Constipation Quality-of-Life~          Questionnaire (PAC-QOL) in women receiving routine docusate sodium after pelvic~          reconstructive surgery.~        2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent~          constipation following pelvic reconstructive surgery by decreasing time to first BM,~          decreasing GI symptoms associated with constipation, and increasing measures of~          GI-related quality of life, while minimizing the bothersome side effects associated~          with stimulant laxatives.~   "
104311|NCT01691729|"~     To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory~     products.~   "
104312|NCT01691716|"~     The purpose of this study is to determine whether Tendoactive, eccentric training, or the~     combination or both could be effective in the treatment of Achilles tendinopathy.~   "
104313|NCT01691703|"~     A difficult tracheal intubation can be a problem, even if one has taken all precautions. A~     possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation~     scope. As such, the videolaryngoscope can be used to achieve the best possible view and~     space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation~     scope.~   "
104314|NCT01691690|"~     Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate~     pain for pediatric patients. Its common use (particularly in oral form) is underscored by~     its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse~     systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.~      Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated,~     these mechanisms appear to be multi-factorial and include central inhibition of the~     cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from~     arachidonic acid, interference with serotonergic descending pain pathways, indirect~     activation of cannabinoid CB1 receptors and inhibition of nitric oxide pathways through~     N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known~     is that of central inhibition of COX enzymes by which the decreased production of~     prostaglandins diminish the release of excitatory transmitters of substance P and glutamate~     which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).~      To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric~     population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et~     al, 2009; Hong et al, 2010).~   "
104315|NCT01691677|"~     Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As~     adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or~     400 μg twice daily, was well tolerated and significantly more effective in reducing the~     symptoms of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of~     fluticasone propionate to xylometazoline and antimicrobial therapy with cefuroxime improved~     clinical success rates and accelerated recovery of patients with a history of chronic~     rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis.~      The present study was planned to assess the effects of nebulised beclomethasone dipropionate~     given as add-on therapy to standard care (oral antibiotics) in the treatment of acute~     symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.~   "
133872|NCT01302704|"~     The purpose of this study is to demonstrate if Proton Pump Inhibitors (PPI's) decrease blood~     levels of 25-Hydroxyvitamin D (25-OH Vitamin D).~   "
104316|NCT01691664|"~     Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy~     uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive~     cellular therapy after surgery may be more effective than uses radiation therapy alone in~     treating esophageal cancer.~   "
104317|NCT01691651|"~     The purpose of this study is to associate the use of botulinum toxin type A for patients~     with keratoconus to demonstrate that tension eyelid has an important role in disease~     progression.~   "
104318|NCT01690663|"~     When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory~     and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic~     shoulder surgery. This study seeks to determine if there is a relationship between the~     duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)~     when combined with increasing doses of dexamethasone.~   "
104319|NCT01690650|"~     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral~          oxygenation is interesting. The investigators will evaluate the capability of the INVOS~          Oximeter to detect induced changes in the cerebral regional saturation.~        -  The purpose of the study is to investigate our hypothesis that cerebral~          vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term~          infants.~   "
104320|NCT01690637|"~     This is a prospective, randomized, double-blind, placebo-controlled trial that will be~     conducted in tertiary care pediatric hospitals in El Salvador and Panama. The primary~     purpose of this study is to determine whether empiric oseltamivir phosphate treatment given~     at the time of hospital admission to children less than 10 years of age hospitalized with~     influenza can effectively reduce their illness severity. Additional objectives are to: 1)~     evaluate the tolerability of oseltamivir phosphate treatment, 2) evaluate the effect of~     oseltamivir treatment on viral clearance and development of oseltamivir-resistant influenza~     virus during and after treatment in children hospitalized with influenza, 3) estimate the~     direct and indirect costs of all-cause respiratory illness and influenza-associated~     respiratory illness requiring hospitalization, and 4) evaluate the effect of empiric~     oseltamivir treatment during the influenza season on these costs.~      The primary study hypothesis is that children with laboratory-confirmed influenza receiving~     empiric oseltamivir phosphate treatment initiated at the time of hospital admission will~     have a shorter duration of hospitalization and a shorter time to resolution of signs of~     severe respiratory illness compared to children receiving placebo. The secondary study~     hypotheses are that children with laboratory-confirmed influenza receiving oseltamivir~     phosphate treatment will have a reduction in the time to non-detectable influenza virus and~     influenza viral RNA and children with all-cause respiratory illness receiving oseltamivir~     phosphate will not be more likely to experience severe adverse events than children~     receiving placebo.~   "
104321|NCT01690624|"~     Patients with acute myeloid leukemia who experience a relapse after at least one prior~     regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are~     in complete remission with high risk to relapse may be eligible for this trial. The trial~     will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose~     levels.~   "
104322|NCT01690611|"~     The goal of this research is to determine if real time visual feedback of body movements~     improves balance control more than walking on a treadmill alone. Individuals participating~     in this research study will be tested using a battery of clinical strength and balance~     assessments twice before a 4 week training period and once after the training period. The 4~     week training period will consist of 12 sessions walking on a treadmill. The experimental~     group will see real time visual feedback regarding their body movements, and the control~     group will not receive this visual feedback. Following the 4 week training each participant~     will again be tested using the battery of clinical strength and balance assessments.~   "
104323|NCT01690598|"~     The purpose of this study is to investigate the effect of combined topotecan and veliparib~     (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown~     BRCA mutation status.~   "
104324|NCT01690585|"~     The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a~     common disorder in the elderly. Indeed, in 1996, in a French study, the median age of~     patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in~     the studies reported in English the median age was 71. If epidemiological data concerning~     lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies~     from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic~     procedures and current resuscitation methods, gastrointestinal bleeding prognosis has~     greatly improved, whereas anaemia related to a bleeding episode remains a frequent~     complication of gastrointestinal bleeding in elderly patients.~      Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on~     the criteria used and populations studied. The occurrence of a bleeding episode can either~     induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal~     bleeding are often unaware of anaemic consequences in the elderly patients which can often~     be serious. Various studies have shown that anaemia increases morbidity and mortality rates~     in the elderly. Life expectancy is independently significantly lower for anaemic patients~     over 65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of~     cardiovascular and neurological complications, impairment in cognitive function and~     increased risk of falling.~      Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized~     for upper or lower gastrointestinal bleeding should be corrected rapidly and effectively.~     Currently, the cost and risks of infection or cardiovascular-related complications of~     transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL~     haemoglobin. It is also necessary to develop alternatives to massive transfusions. The~     correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.~      In clinical practice, the effectiveness of iron intake by the oral route is limited by the~     frequent occurrence of significant gastrointestinal side effects that limit patient~     compliance and limited absorption necessitating prolonged treatment to correct iron~     deficiency.~      The black colour of stools caused by taking oral iron supplements also makes it difficult to~     detect a possible recurrence of bleeding after hospitalization.~      The prescription of intravenous iron seems more suitable for a rapid and complete correction~     of iron deficiency after gastrointestinal bleeding. The main objective of our study is to~     evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin~     at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary~     objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron~     supplementation, the rate of re-hospitalization within 6 months after discharge and patients~     quality of life. This is a prospective multicenter randomized study versus placebo. After~     obtaining informed consent, all patients aged over 65 admitted with upper or lower~     gastrointestinal bleeding, with successful outcome, not related to portal hypertension,~     responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will~     be included in the study. Patients will be treated for their bleeding event in the usual~     manner of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of~     external bleeding and haematocrit and/or constant haemoglobin levels will be considered as~     the end of bleeding.~      Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1~     included: obtaining informed consent of the patient, determination of iron and ferritin~     blood levels and complete blood count. and randomization intravenous iron injection ,~     (Ferinject) versus Placebo. Intravenous iron injection will be performed at Day 0. A~     complete blood count will be performed at week 6 and month 6. Patients will be reviewed in~     consultation at week 6 and at month 6 to obtain related intercurrent events and assess their~     quality of life.~      The results of this study could lead to changes in the care of older patients hospitalized~     for gastrointestinal bleeding.~   "
104325|NCT01690572|"~     Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic~     in diffuse small vessel disease especially of diabetic patients. High restenosis rates after~     balloon only procedures in small vessels occur due to negative constrictive vessel~     remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is~     not indicated. The main hypothesis of the trial is that in analogy to DCB success in~     peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a~     IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments~     after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty~     (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A~     constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9~     months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA~     therapy.~   "
104326|NCT01690559|"~     This study is a post-marketing surveillance in Japan to investigate the safety especially~     focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv~     administration without dilution in the daily practice.It is a local prospective and~     observational study of patients who have received Ciproxan intravenously for sepsis,~     secondary skin infections followed by superficial burn, post-surgical or post-traumatic,~     pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to~     be enrolled and assessed during the period of treatment with Ciproxan.~   "
104327|NCT01690546|"~     The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment~     to transfer opioid dependent individuals to extended release naltrexone injection~     (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol~     successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.~   "
104328|NCT01690533|"~     The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg~     (hereinafter as Avelox) in treating secondary infection of chronic respiratory disease.It~     is a local prospective and observational study of patients who have received Avelox tablets~     for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in~     chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and~     assessed during the period of treatment with Avelox.~   "
104329|NCT01690520|"~     This randomized phase II trial studies how well donor umbilical cord blood transplant with~     or without ex-vivo expanded cord blood progenitor cells works in treating patients with~     acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or~     myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's cells. When the healthy stem cells and~     ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It~     is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded~     cord blood progenitor cells is more effective than giving a donor umbilical cord blood~     transplant alone.~   "
104330|NCT01690507|"~     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the~     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory~     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more~     sensitive to the following adoptive T cell therapy.~   "
104331|NCT01690494|"~     This study is a randomized controlled trial (RCT) that will rigorously evaluate the~     implementation, effectiveness and cost-effectiveness of a couple-based integrated human~     immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with~     drug-involved male offenders charged with misdemeanors and their primary female sexual~     partners, implemented by frontline providers in Criminal Court, Community Court or probation~     (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary~     outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.~   "
104332|NCT01690481|"~     Simplified Brochure~      Neuropsychological Testing/Assessment is like games for the child. They are asked to~     complete the sequence, identify pictures, explain what is happening, etc. There is no~     personality testing involved. Part of the standard IQ testing is done but no IQ score is~     obtained. Age appropriate testing is done for each child.~      The MRI is an enclosed machine. We have the child sit in a simulator after the~     neuropsychological testing to see what it will be like, including the sounds, etc. You will~     be given a video about MRI testing to view as well. The staff that does this has been doing~     this for years in a wide variety of children, young, developmental delayed, etc. The staff~     does this WITHOUT sedation. Some children cannot sit still through the entire series. We~     need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle~     their toes and move in between each scan.~      The Neuropsychological Testing can be scheduled in the late afternoons if it is more~     convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled~     after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked~     to repeat the Neuropsychological Testing and MRI scanning 24 months later.~   "
104333|NCT01690468|"~     The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe~     and tolerable when given together, and to determine if this combination of drugs can help~     people with recurrent ovarian cancer.~   "
104334|NCT01691638|"~     (A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in European Caucasians)~   "
104335|NCT01691625|"~     The purpose of this study is to show if the adoptive cellular therapy with autologous~     dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent~     chemoradiation could improve the quality of life of the patients with locally advanced~     esophageal cancer, compared with concurrent chemoradiation only.~   "
104336|NCT01691612|"~     Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil~     survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal~     pathways in multiple cells in asthma.~   "
104337|NCT01691599|"~     The objectives of this study are to investigate infection rates and management for open and~     closed tibia fracture subjects in India treated with internal fixation. These objectives~     will be carried out by answering the following questions:~        1. What is the infection rate within one year of surgery for open and closed tibia~          fracture subjects in India treated with internal fixation?~        2. What is the distribution of infection per type of infection, stratified by time (early,~          delayed, late) and location (superficial or deep) in open and closed tibia fracture~          subjects in India treated with internal fixation?~      Secondary objectives~        1. How are infections managed in open and closed tibia fracture subjects in India treated~          with internal fixation?~        2. What is the treatment outcome for open and closed tibia fracture subjects in India~          treated with internal fixation?~        3. What is the influence of the following clinic and subject factors on the occurrence of~          infection within one year for open and closed tibia fracture subjects in India treated~          with internal fixation?~             1. Hospital standard hygienic and antibiotic protocol for infection prevention~             2. Subject demographics~             3. Time between injury and surgery and between admission and surgery~             4. Fracture type (AO Müller classification)~             5. Soft tissue damage (according to the Tscherne classification for closed fractures~               or Gustilo classification for open fractures)~             6. Fracture management and implant type~             7. Surgical details such as duration of surgery~        4. Is there a difference in health-related quality of life as measured by the EuroQol-5~          Dimensions (EQ-5D) between subjects with and without infections?~        5. Is there a difference in the number of complications not related to infection (adverse~          events and serious adverse events) between subjects with and without infections?~   "
104338|NCT01691586|"~     A relatively new and promising development in the area of cardiovascular implantable~     electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate~     the device automatically and send the data from the patients' home to the physician, thereby~     reducing in-clinic follow-ups.~      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus~     in-clinic follow-up only on patient-reported health status and device-acceptance after~     implantation with an implantable cardioverter defibrillator (ICD) or cardiac~     resynchronization defibrillator (CRT-D).~      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic~     visits or vice versa due to specific clinical and psychological factors and (2) To~     investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic~     follow-up only.~   "
104339|NCT01691573|"~     The main objective of the European Pediatric Catheter Ablation Registry is to collect data~     on ablation procedures in the European pediatric population in order to improve the~     management of this subset of patients.~   "
104340|NCT01691560|"~     The purpose of this exploratory study is to compare the treatment effect on dentinal~     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile~     sensitivity. This proof of concept study will compare the test dentifrice with three other~     treatment groups.~   "
104401|NCT01690767|"~     Children 0-24 months of age requiring a urethral catheterization for urine collection will~     be randomized to receive either topical and intraurethral 2% lidocaine or standard of care~     to assess for the effectiveness of the former in minimizing pain during urethral~     catheterization. It is hypothesized that administration of 2% lidocaine gel both topically~     and intraurethrally will confer a greater degree of pain reduction compared to standard of~     care.~   "
104341|NCT01691547|"~     This is a double-blind, single dose (four inhalations), four-way cross over study in healthy~     subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics~     (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will~     be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a~     two strip configuration. The NDPI will be configured with different combinations of each~     compound and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI~     device. Study drug will be administered through the inhaled route to healthy subjects in~     single doses (four inhalations). Each subject will receive treatment in a randomized order~     Treatment A FF (400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg)~     and VI (100 µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and~     UMEC (500 µg) over four treatment periods. Each treatment period will be separated by a~     washout of 7 to 21 days. After the four treatment periods, a follow up visit will take place~     7 to 21 days following the final dose of study medication and the maximum duration a subject~     will be involved in the study is eighteen weeks.~      Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of~     FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart~     rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected~     throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and~     clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout~     the study.~   "
104342|NCT01691534|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824~     plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus~     Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as~     per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log~     CFU per ml sputum over the time period Day 0-14 in participants with smear positive~     pulmonary tuberculosis (TB). A control group will receive standard treatment.~   "
104343|NCT01691521|"~     This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg~     subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in~     subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be~     measured by a reduction in the frequency of asthma exacerbations. Additional efficacy~     assessments will include measurements of lung function, symptom scores, and quality of life.~     Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse~     events.~      This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in~     MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in~     period. Those subjects that are not able/eligible to be randomised at the end of the 6 week~     run-in period will be deemed run-in failures. Subjects will remain on their current~     maintenance therapy throughout the run-in, double-blind treatment administration and~     follow-up periods. Subjects who meet the randomisation eligibility criteria will be~     randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a~     total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC~     and placebo i.v. or Placebo i.v. and placebo SC.~      Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility~     criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to~     participate in the OLE trial.~   "
104344|NCT01691508|"~     This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of~     mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects~     with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase~     (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase~     (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase~     (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS~     (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a~     review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction~     Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either~     mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition~     to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation~     Phase. The Induction Phase will allow sufficient time for those subjects randomised to the~     mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the~     reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg~     mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks~     using the reduction titration schedule based on a review of eDiary parameters recorded by~     the subject, the subjects' exacerbation history, and a review of the signs and symptoms of~     adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any~     further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet~     the eligibility criteria, will be offered the opportunity to participate in an open label~     extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their~     last dose of double blind study treatment. At each clinic visit, adverse events, safety~     labs, spirometery parameters and exacerbations will be assessed. The pharmacokinetic samples~     will be collected in the beginning of the treatment, prior to last dose, at the end of study~     (exit visit) and the follow up.~   "
104345|NCT01691495|"~     Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic~     disease. It has recently been approved in the European Union (EU) for the treatment of~     patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein~     thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK)~     committed to evaluate physicians' adherence to fondaparinux prescribing information~     regarding proper diagnosis and dosing for the treatment of SVT.~      The primary objective is to evaluate physicians' adherence to fondaparinux prescribing~     information for the treatment of patients with SVT without concomitant DVT.~      The study is designed as a non-interventional, retrospective chart review of patients~     prescribed fondaparinux to treat their SVT. The study will be conducted in several EU~     countries.~      ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.~   "
104346|NCT01691482|"~     The objective of this study is to assess the daily variation in bronchodilator response to~     an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting~     anticholinergic (ipratropium) individually and when used in combination in subjects with~     COPD.~   "
104347|NCT01691469|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
104348|NCT01691456|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
104349|NCT01691443|"~     The objective of this study is to investigate the effect of vibration feedback on the~     gripping pressure in the territory of the median nerve.~   "
104427|NCT01690221|"~     The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride~     cream) is safe and to see if it will help with treatment of pain associated with anal~     fissures.~   "
104350|NCT01691430|"~     Urinary tract infection (UTI) is the most common infection in nursing home residents, and~     bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.~     The primary aim of this study is to test the efficacy of two oral cranberry capsules per day~     in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims~     will be accomplished by conducting a double blind randomized placebo controlled efficacy~     trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female~     nursing home residents.~   "
104351|NCT01691417|"~     Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery~     and its influence on cardiac activity in healthy subjects, the investigators expect to~     improved cardiac function in patients suffering from congestive heart failure.~   "
104352|NCT01691404|"~     Flavonoid-rich foods such as tea and cocoa have been identified as having a blood~     pressure-lowering effect. Part of this effect is thought to be due to the flavonoid content~     of these foods although it is currently unknown which flavonoids play a role. Epicatechin is~     one the major flavonoids in cocoa while quercetin is largely found in tea.~      During this study the investigators plan to investigate the effects of pure epicatechin and~     quercetin supplementation on vascular function and blood pressure in untreated~     (prehypertensive) subjects by way of a three-armed double-blind crossover intervention.~     Participants will sequentially consume supplements containing quercetin, epicatechin or~     placebo for a period of 4 weeks. Before and after this 4 week period, measurements of~     vascular function and blood pressure will be taken.~      The investigators hypothesize that the supplementation of epicatechin and quercetin will~     improve vascular function and blood pressure.~   "
104353|NCT01691391|"~     3rd line standard treatment of patients with metastatic colorectal cancer (CRC) harboring~     K-ras wild type consists of anti-EGFR treatment with either cetuximab or panitumumab. This~     type of treatment has a modest but significant beneficial activity in this patient group~     with improved progression-free and overall survival. Although it is well known that patients~     with advanced CRC harboring a K-Ras mutation will not respond to anti-EGFR treatment, it is~     not understood why patients with K-Ras wild type CRC do not all benefit from this type of~     therapy. In order to optimize treatment of these patients as well as health care costs, it~     is extremely important to identify those patients who will respond to treatment with an EGFR~     inhibitor at an early stage.~      The investigators hypothesize that the differences in response to treatment with cetuximab~     are due to variability in the pharmacokinetics and -dynamics of the antibody. Thus, the~     investigators hypothesize that patients who do not respond to anti-EGFR treatment, have~     insufficient drug levels in tumor tissue. The investigators hypothesize that this is due to~     pharmacodynamic processes such as sequestration of cetuximab in the liver which expresses~     high levels of EGF receptor.~      With the introduction of immuno-positron emission tomography (PET), an attractive novel~     option to visualize molecular interactions has been developed using the combination of PET~     with labeled mAbs. Cetuximab labeled with zirconium-89 (89Zr) has been successfully~     generated (GMP) and is available for this study. Previous studies have shown excellent~     stability of this compound and 89Zr is shown to be safe in humans. The investigators will~     use 89Zr-cetuximab to demonstrate tumor targeting by imaging and explore the relation of~     uptake with treatment response. With this approach the investigators hope to achieve a~     better understanding of the mechanisms of action of this therapeutic mAb in metastasized CRC~     and eventually develop strategies that may improve efficacy of cetuximab treatment.~   "
104354|NCT01691378|"~     The purpose of this project is to provide further evidence regarding a groundbreaking~     psychological treatment for suicide prevention in individuals with moderate to severe~     traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five~     randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for~     affective distress after TBI and the first conducted in the United States (U.S.) to~     specifically address suicide risk as an outcome.~      The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert~     Consensus Conference, participant total up to 15), implement the intervention in a VAMC~     (Pilot Groups 1-4, participant total up to 12), and replicate the results from the original~     trial in this novel context with a larger sample size (n=70 completed protocols [up to 90~     recruited]. Deliverables are expected to include an intervention suitable for both~     dissemination and larger Phase III trials.~   "
104355|NCT01691365|"~     Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can~     offer significant protection against infections and cardiovascular disease (CVD) especially~     in diabetic patients. The proposed study will determine whether improvements in antioxidants~     and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead~     to a clinical benefit~   "
104356|NCT01691352|"~     Countless children undergo surgery annually for management of what clinicians consider to be~     a dirty wound. One frequently encountered example is the ostomy reversal. During this~     planned operation, the previously diverted small bowel or colon is reconnected with the~     distal intestine, restoring continuity. However, this procedure leaves an open wound on the~     anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how~     should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a~     wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to~     evaluate these two dressings in children receiving an ostomy closure. The investigators~     hypothesis is that the incidence of wound infection after ostomy reversal is the same~     regardless of if a wick is placed or not.~   "
104357|NCT01691339|"~     The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18~     years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to~     <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).~      Primary Objective:~        -  To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone~          Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 -~          2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone~          Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the~          2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years~          of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,~          Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the~          requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance~          (NfG) CPMP/BWP/214/96.~        -  To submit remaining available sera from subjects given Fluzone vaccine to the Center~          for Biologics Evaluation and Research (CBER) for further analysis by the World Health~          Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food~          and Drug Administration (FDA) to support selection and recommendation of strains for~          subsequent years' influenza vaccines.~   "
106939|NCT01657149|"~     To investigate the effects of lymphatic drainage massage performed immediately after total~     knee replacement in relation to reduction of limb circumference, pain reduction and~     functional improvement.~   "
104358|NCT01691326|"~     The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone~     vaccine.~      Objective:~        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in~          a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization~          Practices (ACIP) recommendations, in children 6 months to < 9 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,~          administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~        -  To submit remaining available sera from subjects to the Center for Biologics Evaluation~          and Research (CBER) for further analysis by the World Health Organization (WHO), the~          Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration~          (FDA) to support selection and recommendation of strains for subsequent years'~          influenza vaccines.~   "
104359|NCT01691313|"~     Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in~     a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or~     flutter of recent onset to normal sinus rhythm.~   "
104360|NCT01691300|"~     Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT~     PET/CT) may help detect lesions before treatment and evaluate response following therapy in~     patients with from multiple myeloma (MM). This study aimed to prospectively assess the~     clinical utility of ACT PET/CT in MM as compared to the commonly used~     F18-fluorodeoxyglucose(FDG).~   "
104361|NCT01691287|"~     Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires~     personal checks of blood sugar levels, injecting insulin, changing eating habits and~     physical exercise, which requires a real change in the life of the child & adolescent and~     can cause significant damage to the quality of life as well.~      Compliance to treatment is a major challenge for all patients and mostly to adolescence,~     which often worsen their diabetes control at that age.~      The Michael Method is a unique, holistic program to develop and realize an individual's~     emotional, intellectual and behavioral potential, which is based on the belief that every~     human being can excel in every field they choose. The method was developed in 1988 by a~     multi-disciplinary team of professional academic in Israel. Today the Israeli education~     system implements the method in Junior High Schools and High Schools in diverse educational~     sectors. The program is taught at many other various frameworks: teachers' continuing~     education programs, colleges, programs run by the Ministries of Defense and Social Welfare,~     the National Insurance Institute, the National Electric Corporation and in many other public~     and private frameworks.~      The proposed study is aimed to assess whether the Michael Method can be used as a tool for~     improving metabolic control and quality of life among uncontrolled adolescence with type 1~     diabetes~   "
104362|NCT01691274|"~     The purpose of this study in healthy people is to investigate safety, toleration and time~     course of plasma concentration of PF-04895162, following multiple oral doses for 14 days.~     The preliminary effect of food on Pharmacokinetics (PK) after single oral dose of~     PF-04895162 will also be investigated.~   "
104363|NCT01691261|"~     Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related~     macular degeneration in whom there is rapidly progressing vision loss~   "
104364|NCT01691248|"~     The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus~     placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult~     participants undergoing hematopoietic stem cell transplantation (HSCT). The primary~     hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants~     undergoing HSCT.~   "
104365|NCT01691235|"~     Subjects are being asked to participate in this study because they have genotype 1 Hepatitis~     C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,~     and telaprevir as part of their routine care. The purpose of this study is to see if the~     SIMpill automated pill dispensing device can help subjects take their medications at the~     times the doctor has instructed them to take it.~      The SIMpill device is an automated pill dispensing device that records a time stamp each~     time the device is opened and a dose of medication is taken. Physicians can download this~     data and generate a precise account of when you have taken your medication. In addition, if~     a dose is missed, the SIMpill device can be set to automatically notify you by text message~     if a dose is overdue. The Simpill device is a new way to keep track of when you take your~     HCV medications and will also help remind you when you forget to take a dose. In addition,~     this information will help your doctors understand how taking medication on time effects the~     success of the therapy.~   "
104366|NCT01691222|"~     Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible~     fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the~     patients. This situation may lead to many disadvantages for ventilation and airway~     protection of critically ill patients during the procedures. The use of double lumen~     endotracheal tube dedicated to the percutaneous tracheostomies may:~        1. improve the ventilation of patients during the procedure,~        2. protect the posterior tracheal wall from damage related to the different step of~          tracheostomies,~        3. protect the lungs from blood and secretions coming down from the chosen site of~          tracheostomy.~      So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and~     complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen~     endotracheal tube.~   "
104367|NCT01691209|"~     The study shall explore whether treatment of atopic dermatitis is equally effective with~     Phoenix medical device as compared to standard therapy (Hydrocortisone cream).~   "
104368|NCT01691196|"~     Our study addresses the following research question: What is the role of obesity in~     modulating inflammation and innate immune function, as well as the overall responsiveness of~     innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in~     patients undergoing peritoneal dialysis?~      The investigators hypothesize that obesity will lead to increased inflammation in patients~     undergoing peritoneal dialysis.~   "
104369|NCT01691183|"~     The purpose of this research study is to learn about the variability in proptosis~     measurements. Measurements will be recorded using the Hertel exophthalmometer. This~     noninvasive tool is an instrument designed to measure the forward protrusion of the eye and~     may be used normally during a general eye exam. This instrument provides a method of~     evaluating and recording the progression and regression of the prominence of an eye caused~     by disorders such as thyroid disease and tumors of the orbit.~   "
104370|NCT01691170|"~     The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior~     aspect of the knee, although peripatellar pain and / or retropatellar are also common. In~     general, conservative treatment is the initial option of choice for patients with PFPS,~     however, the lack of a specific causal factor makes it difficult to choose the best~     treatment so early. This way, the purpose of this study is investigate the effects of the~     quadriceps femoris strengthening versus hamstring stretching in patients with~     pattellofemoral pain.~   "
104371|NCT01691157|"~     The purpose of this trial is to investigate the effectiveness of an evidence based exercise~     program for shoulder impingement. Approximately 1% of adults consult their General~     Practitioner (GP) with shoulder pain each year, making it the third most common reason for~     musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed~     with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly~     referred for physiotherapy treatment. This trial aims to compare the effectiveness of an~     evidence based exercise protocol with usual physiotherapy care.~   "
104372|NCT01691144|"~     Follow-up of cancer patients accounts for a substantial part of outpatient activity, and~     alternative models of care are developing. In some countries, low-risk follow-up is already~     done in primary care, mainly in breast, and colorectal cancer. In this study the~     investigators will explore gynecological cancer patients about their expectations regarding~     their future follow-up plan. Further, the investigators will ask about the experience and~     satisfaction among patients who have already attended a follow-up programme for 2-3 years.~     In addition, the investigators will especially focus on the cooperation aspect between~     primary and secondary care. The investigators hypothesize that follow-up of selected~     gynecological cancer patients can be done by general practitioners.~   "
104373|NCT01691131|"~     Introduction: There is evidence that demonstrate the beneficial effects of pulmonary~     rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of~     life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the~     studies used high intensity endurance and strength exercise training on land. Exercise on~     water is an effective form of training that has been used for decades for rehabilitation in~     different chronic conditions. In addition, there are promising preliminary results on the~     literature regarding aquatic training in patients with COPD. However, several gaps remain.~      Aim: Compare the effects of two rehabilitation programs with 6 months of duration in~     patients with COPD on physical activity in daily life and balance: land versus water.~      Methods: The sample will consist of 60 patients with COPD diagnosed according to the GOLD~     criteria, 50 years old or more and clinically stable.~      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months~     after the end of the PR (follow up). In addition to the assessment of physical activity in~     daily life and balance, the investigators will also evaluate pulmonary function, peripheral~     and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,~     functional status and quality of life.~      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,~     with 45 minutes of duration, during 6 months. The sessions of both groups include the same~     exercises sequence. Endurance exercise training will be performed on a bicycle and walking~     on land and strength training using free weights. Workload will be established according to~     the tests performance on assessment and progression will follow a predetermined schedule and~     adjusted according symptoms. On water the same approach will be followed.~      Expected results: the investigators expect improvement in terms of symptoms, exercise~     capacity, muscle strength, quality of life, functional status and physical activity in daily~     life at the end of the two training protocols. However, it is unclear whether one training~     protocol will be superior than the other. Due to the characteristics involved in the aquatic~     training, the investigators hypothesized that this type of training can result in better~     results on balance.~   "
104374|NCT01691118|"~     Approximately half of hypertensive patients have diastolic dysfunction and diastolic~     dysfunction is associated with development of congestive heart failure and increased~     mortality. Although diastolic heart failure associated with hypertension is a clinically~     significant problem, few clinical trials have been conducted and there is no proven~     pharmacological therapy to improve outcomes. To the best of the investigators knowledge,~     there has been no randomized trial to demonstrate that an antihypertensive drug improves~     diastolic function in hypertensive patients with diastolic dysfunction. The investigators~     hypothesize that fimasartan added to standard therapy will be superior to placebo in~     improving diastolic dysfunction in mildly symptomatic patients with hypertension and~     diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized~     comparison study using echocardiography.~   "
104375|NCT01691105|"~     This study will implement and test the effectiveness and cost-effectiveness of a tobacco~     cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for~     adults admitted to the hospital. The intervention will begin during the hospital stay and~     continue after discharge. The intervention will use resources easily available to most acute~     care hospitals: computerized physician order entry, physician and nurse education, staff~     meetings for physicians, nurses and allied health professionals, online learning~     capabilities, faxing to primary care providers (PCPs), and the telephone counseling and~     support available from a state smokers' quitline (QL).~      The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be~     more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in~     the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self~     report and biochemical verification (exhaled carbon monoxide reading).~   "
104376|NCT01691092|"~     This study is designed to look at that involvement of a process in the brain called the~     glutamate system in depression. Participants will undergo a screening session, up to two~     fMRI scans, and up to three PET scans, as well as cognitive testing at each scan session.~     For one of the PET scans, a drug (either ketamine or n-acetyl cysteine) will be~     administered.~      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine~     (NAC) will lead to a decrease in mGluR5.~      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills~     after drug challenge.~      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in~     MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.~      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5~     availability due to differences in ABP688 radiotracer infusion.~   "
104377|NCT01691079|"~     This will be a double-blind placebo-controlled study in which we plan to study 40~     competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen~     uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests~     the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will~     compare the athletes' airway response to the exercise challenge with and without the active~     drug.~   "
104378|NCT01691066|"~     The purpose of this study aims to investigate the utility of Pivotal Response Treatment~     (PRT), a behaviorally derived intervention, to improve the quality and frequency of~     communication and social engagement of toddlers with siblings who have an autism spectrum~     disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social~     interaction between 12 and 15 months of age.~   "
104379|NCT01691053|"~     End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality.~     Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left~     ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an~     independent predictor of survival. Yet, to date there is no established medical treatment to~     reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone~     action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection~     and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has~     recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease~     (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective~     by reducing LVM in ESRD patients on dialysis.~   "
104380|NCT01691040|"~     This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in~     patients with anemia of chronic disease (ACD). Furthermore, this study is intended to~     provide data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to~     choose the appropriate dose and dose schedule of subsequent efficacy studies.~      Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high~     hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in~     iron concentrations in the blood and subsequently impair formation of red blood cells.~     Treatment with NOX-H94 is expected to inhibit this patho-mechanism by binding and~     inactivating hepcidin.~   "
104381|NCT01691027|"~     The research is aimed at developing and testing a new method of visual-motor rehabilitation~     of Veterans with macular degeneration by using inexpensive tablet computers at home.~   "
104382|NCT01691014|"~     The rationale for this study is to further explore if development of antibodies against~     TNF-α blocking agents is associated with reduced clinical effect/worsened clinical outcome.~     An important aspect of the study is to carry out an exploratory analysis of the~     immunogenicity of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using~     the same cell-based assay.~   "
104383|NCT01691001|"~     Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a~     frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent~     selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and~     anaesthetics that must be concomitantly administered. This study was conducted to assess the~     effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA~     in children undergoing ambulatory surgery.~   "
104384|NCT01690988|"~     Delirium is a medical term or condition that includes a temporary inability to focus~     attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than~     60 undergoing large surgeries. The purpose of this study is to test rigorously whether a~     drug called ketamine can decrease the chance that patients will experience delirium after~     their surgery. The investigators are also testing whether ketamine decreases postoperative~     pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital~     length of stay, and adverse outcomes (e.g. hallucinations and nightmares).~   "
104385|NCT01690975|"~     This is a single-center, randomized, third party blind, placebo controlled, dose escalation~     study of benzonatate following single dose administration. The primary oobjective is to~     assess the safety and tolerability of increasing oral doses of benzonatate following single~     dose administration in healthy male and female subjects.~   "
104386|NCT01690962|"~     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a~     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation~     and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet~     changes. The principal measure is pain as measured by the following assessment tools:~     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy~     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale,~     McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.~      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for~     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.~   "
104387|NCT01690949|"~     This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced~     airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal~     volunteers.~   "
104388|NCT01690936|"~     Identifying snacks that do not contribute to positive energy balance is crucial in weight~     management. The satiating effects of almonds, coupled with their convenience and~     palatability make them a promising weight management aid. Therefore, this study aimed to~     examine the effects of almond consumption with meals versus snacks on outcomes such as~     appetite, energy intake, body weight, as well as blood glucose, insulin and lipid responses.~   "
104389|NCT01690923|"~     The aim of this evaluation is to test:~        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks~        2. Patient mask type preferences at high pressures~   "
104390|NCT01690910|"~     This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to~     assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of~     critically ill ventilator dependent patients in the intensive care units (ICUs) and improve~     important patient outcomes. The pilot study is designed to assess the feasibility and~     logistics of doing a study of this nature in the ICU; it will also provide the means to~     obtain estimates of outcome effect sizes, number of repeated measures, time between repeated~     measures, and intra-subject and intra-unit correlations, to be used for sample size~     calculations.~   "
104391|NCT01690897|"~     The purpose of this study is to test and determine the efficacy of an 8-session~     mindfulness-based psychoeducational intervention for women with sexual interest/ desire~     concerns when compared to a wait-list control condition.~   "
104392|NCT01690884|"~     The investigators are trying to determine if a single dose of Ticagrelor will increase~     delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with~     adenosine reuptake blockade.~   "
104428|NCT01690208|"~     This is a pilot translational study aiming to compare the effects of a multi-component care~     program with personalized drug regimen augmented by behavioural therapy with psychological~     support and peer influence, led by a diabetes specialist team on metabolic control,~     psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus~     usual care.~      The study hypothesis is to evaluate a novel individualized, multicomponent care program to~     optimize glycemic control in difficult-to-treat type 2 diabetic patients.~   "
104393|NCT01690871|"~     Study objectives:~      The primary objective is to determine the efficacy of BEZ235 on Objective Response Rate~     (best response on study) according to RECIST 1.1 criteria~      The secondary objectives are:~        -  To determine the progression free survival rate at 32 weeks in the included population~        -  To assess the duration of response among responders~        -  To evaluate time to response~        -  To evaluate the time to progression~        -  To assess the overall survival~        -  To evaluate safety and tolerability of BEZ235~      The exploratory objectives are:~        -  To identify molecular and genomic profiles of PEComas and their potential relationship~          to clinical outcome by analyzing PIK3CA, Ras, Raf, TSC, AKT and PTEN alteration in~          tumor samples (archival or fresh pre-treatment tumor biopsy) and PIK3CA in circulating~          DNA.~        -  To determine biomarkers relevant to BEZ235 activity by analyzing the expression of~          phosphoproteins p-AKT, p-S6, p-4EBP1 at screening and during treatment as well as~          biomarkers for the proliferation (Ki-67) and apoptosis (PARP) (only if fresh tissue~          (optional) is available).~      Study population:~      The patient population consists of patients 18 years old or older with progressive~     unresectable/advanced or metastatic malignant PEComas previously treated for~     unresectable/advanced/metastatic disease with 1 to 2 prior lines of chemotherapy. Patients~     must have adequate hematologic, renal, cardiac and hepatic functions and not be previously~     treated with a mTOR inhibitor.~      Number of patients:~      16 to 33 patients~      Overview of study design:~      This is a prospective, multicenter, open-label, single arm, two-stage phase II study to~     investigate the efficacy and tolerability of BEZ235 in patients with progressive metastatic~     or unresectable/advanced malignant PEComas. The patient should have received 1 or 2 prior~     lines of chemotherapy.~      BEZ235 will be administered until disease progression. Sixteen patients will be enrolled~     into Stage 1 and observed for at least 32 weeks at which time an interim analysis will be~     performed (plus eventually 4-5 weeks for confirmation of responses occurring on or closely~     before this cut-off date). If the number of patients with a response (CR or PR) is 2 or~     less, the trial will be stopped for futility. If 3 or more patients experience a response~     enrollment will continue up to 33 patients (Stage 2).~      An Independent Data Monitoring Committee (IDMC) will be constituted for reviewing the~     interim analysis.~   "
104394|NCT01690858|"~     The aim of the study is to assess the role of complement dysregulation and its impact on~     antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.~   "
104395|NCT01690845|"~     Hypoxic hepatitis (HH) is reported to be the most frequent cause of elevated~     aminotransferase levels in hospital. Up to 10 % of critically ill patients develop HH during~     the course of their intensive care unit (ICU) stay. Occurrence of HH is a life threatening~     event and ICU-mortality is reported to be up to 60%. Early therapeutic intervention is of~     central prognostic importance in patients with HH to improve the hemodynamic impairment as~     early as possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression~     of organ failure and to improve outcome. Studies reported that Molecular Adsorbent~     Recirculating System (MARS®) therapy improved the hemodynamic situation in patients with~     acute and acute on chronic liver failure. The study hypothesis is that MARS® therapy in~     critically ill patients with severe HH improves hepatic hemodynamics and function and~     consecutively the course of the disease. 40 patients with suffering of severe HH with~     aminotransferase levels > 40 times the upper limit of normal of more than 12 hours will be~     randomized 1:1 to MARS® therapy (n=20) or conventional therapy (n=20). 4 MARS®-sessions will~     be performed on three consecutive days, each for at least 12 hours. Treatment will be~     continued under special circumstances. The maximum duration of the treatment phase is 7~     days. The primary endpoint is the difference of the indocyanine plasma disappearance rate at~     day 7. The expected duration of the study is 2 years.~   "
104396|NCT01690832|"~     Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury~     (AKI) when they undergo urgent/emergency coronary angiography.~      The optimal medical treatment for preventing the occurrence of contrast induced - acute~     kidney injury is still controversial.~      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that~     has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary~     studies.~      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI~     already shown to be useful for earlier diagnosis of contrast induced nephropathy.~      The primary objective of this study is to to test the hypothesis that fenoldopam, in~     addition to standard treatment, reduce the occurrence of contrast induced - acute kidney~     injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary~     angiography and/or percutaneous coronary intervention.~   "
104397|NCT01690819|"~     Acute respiratory distress syndrome (ARDS) occurs in almost 20% of patients with severe~     acute brain injury and is associated with increased morbidity and mortality. A massive~     increase in sympathetic activity and an increased production of proinflammatory cytokines~     released into the systemic circulation are the most important recognized mechanisms. Altered~     blood brain barrier after injury causes spillover of inflammatory mediators from the brain~     into the systemic circulation leading to peripheral organs damage. The adrenergic surge~     induces an increase in vascular hydrostatic pressure and lung capillary permeability,~     causing an alteration of alveolar capillary barrier with fluid accumulation, resulting in~     ARDS.~      The main goal of mechanical ventilation after acute brain injury are the maintenance of~     optimal oxygenation, and a tight control of carbon dioxide tension, although ventilatory~     settings to be used to obtain these targets, while avoiding secondary insults to the brain,~     are not clearly identified.~      Protective ventilatory strategy has been positively evaluated first in patients with ARDS,~     and then in those undergoing cardiopulmonary bypass or lung resection surgery, or in brain~     death organ donors, but data on the effect of protective mechanical ventilation on patients~     with acute brain injury are still lacking even if this is a population with recognized risk~     factors for ARDS.~      Therefore, the primary aim of this multi-center, prospective, randomized, controlled trial~     is to investigate whether a protective ventilatory strategy, in the early phase after severe~     acute brain injury, is associated with a lower incidence of ARDS, avoiding any further~     damage to the brain. Secondary aim is to evaluate if a protective ventilatory strategy is~     associated with reduced duration of mechanical ventilation, incidence of organ failure,~     intensive care unit length of stay, and lower concentrations of plasma inflammatory~     cytokines, without adversely affect in neurological outcome.~   "
104398|NCT01690806|"~     Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important~     complications of thyroid surgery. The duration of convalescence, after non complicated~     thyroid operation, may depend on several factors of which pain and fatigue are the most~     important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are~     well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects.~     The investigators therefore undertook the present study to investigate whether preoperative~     dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.~   "
104399|NCT01690793|"~     The investigators hypothesize that there is a statistically significant decrease of~     Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels~     following treatment of an exacerbation of asthma.~   "
104400|NCT01690780|"~     Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or~     ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine~     as needed for pain relief for the first 24 hours following discharge from the emergency~     department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We~     hypothesize that oral morphine will result in greater pain relief than ibuprofen.~   "
104429|NCT01690195|"~     This is a long term extension study to evaluate safety and tolerability of subjects who~     complete study M11-793 which is evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.~   "
104402|NCT01690754|"~     In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating~     the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive~     Reminders is an interactive SMS reminder system to help patients remember to take their TB~     medication. In this system, patients receive daily SMS reminders for the duration of their~     treatment at a pre-specified time, reminding them to take their medication. Patients are~     asked to reply back to the system, either through SMS or a missed call, with the time they~     took their medicine that day. If a response is not received within two hours, a second~     reminder is sent. If a response is still not received in a further two hours, a third and~     final reminder for the day is sent. Non-responsive patients are followed up with phone calls~     and a list of non-responsive patients is shared with clinics based on the parameters of~     non-responsiveness that they specify.~      IRD seeks to determine the impact of this system on treatment outcomes and compliance to~     prescribed medication through administering a randomized control trial among newly diagnosed~     TB patients in Karachi, Pakistan.~   "
104403|NCT01690741|"~     This study will be the first to test the anti-cancer peptide Nerofe in humans. It will~     evaluate the safety, pharmacokinetic behavior, and pharmacodynamic and clinical effects of~     Nerofe given intravenously every other day to patients with advanced malignant disease.~   "
104404|NCT01690728|"~     The aim of this study is to increase our knowledge about the effect of physical activity in~     patients who have undergone gastric bypass surgery. The study will provide novel information~     in two areas. The main objective is to study the effect of physical activity on the weight~     loss and cardiovascular risk factors. This will be accomplished in a randomized clinical~     trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to~     six month of structured physical activity or standard postoperative counseling. The study~     will include an exhaustive panel of blood tests related to cardiovascular risk and the most~     extensive evaluation of structural and functional vascular test done in this patient group~     so far. In addition the study will provide information of the effect of bariatric surgery~     per se since both pre- and postoperative investigations are conducted. The study will learn~     us to what degree it is possible to motivate this group of patients to increased physical~     activity. All together this will enable us to improve the counseling of the patients~     undergoing GB.~   "
104405|NCT01690715|"~     A retrospective study based on analysis of medical records of patients with hepatocellular~     carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011~     with diagnosis confirmed by imaging or histological specimen underwent surgical resection~     with curative intent. The study aims to determine the prognostic value of vascular~     complications related to cancer and to evaluate the survival rate of these patients,~     comparing the data with those reported in the literature.~   "
104406|NCT01690702|"~     two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early~     breast cancer~   "
104407|NCT01690689|"~     The purpose is to assess the safety profile and performance of a femoral resurfacing implant~     for localized chondral lesions.~   "
104408|NCT01690676|"~     Effect of apple polyphenols on FMD.~   "
104409|NCT01690455|"~     This observational, multi-center study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients~     in daily clinical practice. Patient will receive Mircera according to local summary of~     product characteristics. Data will be collected for 12 months.~   "
104410|NCT01690442|"~     The proposed study addresses a significant public health threat of HIV, HCV and other STIs~     among a very high risk population of active IDUs and their sexual partners in Kazakhstan a~     region that is experiencing one of the fastest rising HIV epidemics in the world. There is a~     race to develop and implement effective HIV preventive interventions for IDUs and their~     sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other~     Central Asian towns along drug trafficking routes. The proposed study will test the~     effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of~     HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well~     as to reduce unsafe injection practices and increase condom use among injecting drug users~     (IDUs) and their heterosexual, intimate partners in Kazakhstan.~   "
104411|NCT01690429|"~     Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)~     from a finger. This can be measured using the Somnocheck micro system. A pulse wave~     amplitude decrease (PWAD) is considered to be a marker for autonomic activation. Detecting~     the PWAD is a surrogate marker for waking reactions (arousal) which eventually will~     contribute to assess sleep disruption and resulting performance deterioration. Arousal and~     performance deterioration and its possible improvement under continuous positive airway~     pressure (CPAP) therapy will be determined in this study.~   "
104412|NCT01690416|"~     The aim of the project is to compare two methods for arterial cannulation. The traditional~     method with ultrasound guided cannulation. The investigators goal is to improve this~     procedure to reduce pain and complications.~   "
104413|NCT01690403|"~     Primary Objective:~      - To evaluate the effect of single and repeated administration of rifapentine given as daily~     or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and~     tenofovir given as a fixed dose combination (ATRIPLA™ ).~      Secondary Objective:~      - To evaluate the safety and tolerability of concomitant administration of rifapentine and~     ATRIPLA™ given to HIV+ patients~   "
104414|NCT01690390|"~     The primary purposes of this study are to assess the safety and efficacy of using high doses~     of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer~     that achieve stable disease after 8 weeks routine therapy.~   "
104415|NCT01690377|"~     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As~     such they are currently used in clinical vaccination protocols in cancer patients, and both~     immunological and clinical responses have been observed. Several subsets of dendritic cells~     have been characterized in the peripheral blood. One such subset is referred to as~     plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC~     and myDC have not been evaluated for their capability to induce anti-tumor immune responses~     in patients. For this reason the investigators will perform a safety and efficacy study with~     PDC and myDC in stage IV melanoma patients.~   "
134869|NCT01289587|"~     The aim of this study is to evaluate the effects of a physical activity intervention in~     patients with type 2 diabetes in a community setting.~   "
104416|NCT01690364|"~     Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce~     neural damage during neurosurgery.~      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial~     NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is~     preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in~     clinical use. But there have been no reports about the effect of changing NMB agent on~     efficacy of MEP monitoring.~      Therefore, the investigators performed a randomized controlled trial to evaluate the effect~     of changing NMB agent on the variability of MEP amplitude during neurosurgery.~   "
104417|NCT01690351|"~     The primary purpose of this study is to estimate the relative bioavailability and food~     effect of a PF-05089771 capsule.~   "
104418|NCT01690338|"~     The purpose of this study is to determine the incidence of residual curarization in PACU and~     relevant risk factors.~   "
104419|NCT01690325|"~     The GALADON trial is a diagnostic and interventional study in which different molecular~     imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance~     Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods~     (mammography, ultrasound) to see if there can detect an early response to a combined~     neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast~     cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was~     removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to~     the Her2-protein is much more powerful than with chemotherapy alone because it is~     normalizing the blood supply and improves tumor delivery of conventional chemotherapy like~     docetaxel. The HER2 protein is only available in about 30 % of breast cancer types.~     bevacizumab is another humanized monoclonal antibody like trastuzumab but is effective not~     only in patients with an positive HER2 status and in combination with trastuzumab it may~     emphasize the effect in reduction of tumor growth. Bevacizumab is approved in advanced~     disease, but no major neoadjuvant data available so far for primary breast cancer. As the~     therapy with monoclonal antibody regimes are expensive and may cause severe side effects~     predictive factors to select patients who will benefit from such highly specific drugs~     before therapy start would be medically and economically highly valuable. In this study the~     efficacy of combined neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in~     Arm A and bevacizumab and docetaxel in Arm B should be evaluated and the predictive impact~     of different imaging methods for tumor response should be shown.~   "
104420|NCT01690312|"~     The objective of this study is to determine the acute and chronic [4-week] effects of a~     high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of~     cardiovascular disease risk, in adults on Statin therapy.~   "
104421|NCT01690299|"~     This study will test the clinical effectiveness and safety of apremilast compared with~     placebo as well as etanercept compared with placebo in the same group of patients with~     moderate to severe plaque psoriasis.~      Apremilast (CC-10004) is a new oral agent that is under clinical development for the~     treatment of inflammatory autoimmune disorders, such as psoriatic arthritis, psoriasis,~     rheumatoid arthritis, and Behçet disease.~      Etanercept is approved for the treatment of psoriasis; it is the most widely prescribed~     anti-tumor necrosis factor (TNF) for psoriasis.~   "
104422|NCT01690286|"~     The purpose of this study is to evaluate the effects of repeated twice-daily administration~     of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.~   "
104423|NCT01690273|"~     Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore~     axial mobility, but there are no data regarding a specific rehabilitation program that~     includes flexibility alone and its association with resistance exercises in AS patients with~     stable disease activity. So, we assessed the effects of two exercise programs in terms of~     mobility, functional capacity, quality of life and disease activity in AS patients. Methods.~     Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI)~     <4 were included.~   "
104424|NCT01690260|"~     Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an~     exceptional ability to stimulate different characteristics of mesenchymale cells to osseous~     cells. Local application of BMP results in an increase of osseous tissue regardless of the~     location of the growth factor.~      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and~     improve clinical results when autologous bone graft is reduced or removed.~      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace~     autologous bone graft in order to stimulating ossification during transplantation of osseous~     tissue.~   "
104425|NCT01690247|"~     Liver transplantation is the only lifesaving intervention for patients with end-stage liver~     diseases. Despite the ability of current immunosuppressive agents to reduce the incidence of~     acute rejection, the rate of acute rejection reaches to 20-50% after liver transplantation.~     Furthermore, the long-term toxicity associated with current regimens for liver transplant~     recipients now is increasingly being perceived as an unmet clinical need. Mesenchymal stem~     cells (MSC) appeared to be effective in regulating the invoked immune response in setting~     such as tissue injury, transplantation, and autoimmunity, and have been used successfully to~     treat graft versus host disease and show immune modulation function both in vitro and in~     vivo and may help in repairing damaged tissue(s). Here, we evaluate umbilical cord derived~     MSC (UC-MSC) as an alternative immunosuppressive agents for liver transplanted patients, and~     examine if UC-MSC could improve the recovery of liver function.~   "
104426|NCT01690234|"~     In Denmark the number of patients, sick listed for more than four weeks is increasing, and~     patients suffering from musculoskeletal disorders make one third of the total amount of~     long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal~     diseases, including low back pain, are less likely to return to work after a period of sick~     leave. It seems that a multidisciplinary intervention, including cooperation between the~     health sector, the social sector and in the work place, has a positive effect on days off~     work due to musculoskeletal disorders and particularly low back pain. The aim of this study~     is to evaluate the effect of a work oriented multidisciplinary intervention.~      A randomized controlled trial will include 770 patients with low back pain. The study~     population consists of patients, who are sick listed or at risk of sick leave due to LBP.~      The control group is treated with usual care in a team with participation of a~     physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The~     Intervention group is treated with usual care and in addition intervention of a~     psychologist, an occupational physician, an ergonomist and a social worker from the local~     sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome~     will be reported at the end of treatment as well as 6 and 12 months follow up. The primary~     outcome is number of days of work. Secondary outcomes are disability, pain, and quality of~     life.~      This large RCT study is testing the effectiveness of a preventive intervention targeting~     patients on short term sick leave or at risk being sick listed because of low back pain. We~     have developed a novel multidisciplinary team structure using the treating physiotherapist~     as the return to work coordinator, and having the case manager from the sickness benefit~     office participating in team meetings.~   "
104430|NCT01690182|"~     The GI MRI Research group at the University of Nottingham has been developing new,~     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal~     tract. In collaboration with food manufacturer Unilever, the investigators want to image the~     abdomen of healthy volunteers after consumption of test meals of varying volume and energy~     density to determine levels of gastric distension and investigate possible correlations of~     this with the subjects' sense of satiety.~   "
104431|NCT01690169|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of NNC0113-0987 in healthy male subjects.~   "
104432|NCT01690156|"~     Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This~     is usually done in the same plane as the ultrasound beam in America and is known as an~     in-plane technique. When done correctly, the entire needle is visualized on the ultrasound~     screen as it approaches the nerves which are also seen on the same screen the entire time.~     The ultrasound probe can be held perpendicular or parallel to the shoulders of the person~     performing the in-plane technique. Our hypothesis is that holding the ultrasound probe~     perpendicular to the shoulder is superior to holding the probe parallel to the shoulder~     during an in-plane ultrasound guided regional anesthesia technique.~   "
104433|NCT01690143|"~     This study is for patients that have multiple myeloma that has come back or relapsed and~     their condition indicates a procedure called an Autologous Hematopoietic Stem Cell~     Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are~     removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into~     the patient's body to form a new population of blood cells.~      The high-dose chemotherapy administered before the AHSCT is called Conditioning Therapy.~     The FDA has approved the use of the drug melphalan as a conditioning therapy. This research~     study will look at whether adding the study drug called carfilzomib will improve participant~     outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the~     treatment of relapsed multiple myeloma.~      This study is divided into two phases.~      Phase I: Dose Escalation Phase:~      The main purpose of Part I of this study is to examine the safety of the study drug,~     carfilzomib, and determine the safest amount of the study drug that can be given to subjects~     who have multiple myeloma. Subjects on this study will receive different dose levels of the~     study drug. If you are one of the first three subjects to receive the study drug, it will be~     at what is called the 'starting dose' for the study which is the lowest dose that is~     expected to be tolerated based on prior research. After the first set of participants~     receive the study drug, the study doctor will review their health to see how they are~     tolerating the treatment. This will decide if the study drug dosage will be increased or~     decreased for the next set of subjects who join the study. It is anticipated that 12- 18~     participants will enroll in the Phase I portion of this study.~      Phase II: Safety Confirmation Phase:~      Once the study doctor has discovered the highest possible dose of study drug that subjects~     can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of~     the Phase II portion of the study is look at how effective the combination of carfilzomib~     and melphalan when given before your stem cell transplantation is in treating multiple~     myeloma. This expansion phase will also include evaluation of two single agent carfilzomib~     maintenance therapy regimens for patients without disease progression at day 100.~   "
104434|NCT01690130|"~     The proposed study will measure the change of cortical excitability during nicotine craving~     and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine~     craving and cue-reactivity among adult regular smokers.~   "
104435|NCT01690117|"~     The purpose of the present study is to adapt, to implement and to evaluate an support~     program for family caregivers of patients suffering from Alzheimers`Disease (AD). The~     intervention was comprehensive developed and successful evaluated in the USA and is called~     Resources to Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the~     effectiveness of this German adaptation of REACH II the present implementation study is~     designed as randomized and controlled trial. Primary outcome is reducing family caregiver~     burden.~   "
104436|NCT01690104|"~     We are investigating the effects of pregnane X receptor (PXR) activation on the regulation~     of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR~     activator) and placebo will be given for a week to volunteers and blood pressure is measured~     24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will~     be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood~     pressure.~   "
104437|NCT01690091|"~     The aim of the study is to evaluate the effect of metformin on myocardial function, insulin~     resistance and selected metabolic markers in patients with type 2 diabetes and heart failure~     (HF+DM+) in a cross-over, randomized, placebo controlled trial.~      Hypothesis:~      Metformin treatment in HF+DM+ group will lead to better myocardial function and load~     tolerance in comparison to placebo. The degree of improvement will be linked to selected~     metabolic parameters.~   "
104438|NCT01690078|"~     The investigators hypothesize that a functional computational model that simulates the~     mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin~     Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an~     effective diagnostic and treatment planning tool.~   "
104439|NCT01690065|"~     The current standard therapy in previously untreated adults with chronic phase (CP) of CML~     is imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML~     CP is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced~     CML, accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and~     were found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in~     patients with these advanced CML is also disappointing because of low response rates as well~     as short response duration, and sudden transformation to BC is found even in initial CML CP~     patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib~     in terms of rapid response and higher molecular response in newly diagnosed CML~     patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active~     than imatinib even in patients with advanced CML. However, nilotinib in patients with~     imatinib-resistant or -intolerant CML BP showed low hematologic response and major~     cytogenetic response.(22, 23)~   "
104440|NCT01690052|"~     The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in~     the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects~     between the treatment for xerostomia with cevimeline and with pilocarpine.~   "
104441|NCT01690039|"~     Purpose~        1. To compare the performance of the two currently employed urinary acidifications tests~          in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.~        2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on~          urinary acidification in stone formers.~   "
104516|NCT01689064|"~     The purpose of this study is to determine if there is a significant difference in sinonasal~     disease specific quality of life and utility scores between patients undergoing the~     posterior septectomy or Stamm approach during endoscopic pituitary adenoma resection.~   "
134870|NCT01289574|"~     To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice~     daily for facial acne compared to vehicle control.~   "
104442|NCT01690026|"~     This present multi-site investigation compares a voluntary brief intervention for adolescent~     alcohol problems to an educational comparison condition. Measures are taken at intake and at~     4 and 12 weeks post intake to determine effectiveness of the intervention to promote~     personal change efforts and arrest progression of alcohol problems. This study tests~     cognitive mechanisms of change and treatment characteristics and processes associated with~     youth self-regulation to reduce or stop hazardous drinking.~   "
104443|NCT01690013|"~     Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of~     1 in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter~     syndrome have psychological complaints and physical discomfort. Some patients report a~     positive effect of testosterone treatment, whereas others do not.~      The aim of this study is:~      (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To~     investigate functional, physical and mental health in patients with Klinefelter syndrome.~      Questionnaire concerning mental and physical health and life quality are sent out to~     patients with KS and to age-, educational- and zipcode-matched men from the general~     population. The questionnaire include questions about housing, income, marital status,~     fatherhood, medication, chronic disease,school and education, attachment to the labor,~     sexual and erectile function, life quality, mental and physical health, satisfaction with~     life and symptoms of attention deficits hyperactivity disorders.~   "
104444|NCT01690000|"~     The aim of the study is to assess the effect of melatonin treatment in patients with~     osteopenia on BMD, muscle function, quality of life and calcium homeostasis.~   "
104445|NCT01689987|"~     This phase I trial studies the side effects and best dose of hydroxychloroquine when given~     together with cyclophosphamide, dexamethasone, and sirolimus in treating patients with~     multiple myeloma that has come back after a period of improvement or does not respond to~     treatment. Biological therapies, such as hydroxychloroquine, may stimulate the immune system~     in different ways and stop cancer cells from growing. Sirolimus may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells, stopping them from dividing, or by~     stopping them from spreading. Giving hydroxychloroquine together with sirolimus,~     cyclophosphamide, and dexamethasone may be a better treatment for multiple myeloma.~   "
104446|NCT01689974|"~     An attractive area of research regards immune manipulations to recover some of the patient's~     immune response to his/her tumor, a strategy that has the advantages of being both natural~     and potentially long-lasting.[1] We propose to combine immunotherapy with radiotherapy~     directed to a metastatic site, to create a hub for in vivo immunization to the tumor, to~     enable tumor rejection at the other metastatic sites. This in vivo immunization is~     explored as a viable alternative to an individualized vaccine approach. Preclinical data~     generated by us and others support a proof of principle clinical trial that may open the~     field to an alternative use of radiotherapy in a novel partnership with cancer~     immunotherapy.[2]~   "
104447|NCT01689961|"~     Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who~     enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess~     weight gain puts mothers at risk for health problems such as diabetes and developing or~     sustaining obesity after pregnancy, and puts their babies at risk of being born too large or~     developing related health problems. Mothers will be randomized to a structured high dairy~     protein diet and walking program or the usual care by their care provider. The investigators~     research questions are: Will a structured nutrition and exercise program in pregnancy~     compared to usual prenatal care increase the chance that mothers will achieve pregnancy~     weight gain within the current recommendations; improve health measures, in mother and~     infant at six months post-partum; to evaluate the benefits of a high dairy intake in~     pregnancy on maintenance of bone status in the mother and bone health outcomes in the child~     in early life (6 months); and to investigate the interactions between genes associated with~     bone health and high dairy diet supplementation on bone status in mothers during pregnancy,~     and bone health in mothers post-delivery and children to 6 months of age. Mothers' weight,~     physical activity and adherence to the nutrition plan will be assessed until birth and at~     follow-up with their infants at 6 months after birth. The research team will ensure new~     information is quickly transferred to programs to assist women to have healthier~     pregnancies.~   "
104448|NCT01689948|"~     Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its~     prevalence and its medical and social consequences, AD represents a dual challenge to public~     health and society. The elderly want to stay in their homes even when their lives are~     altered by a chronic progressive disease. Their caregivers claim in turn a support at home.~     But this desire is questioned because of the characteristics of the disease, e.g. the~     altered relational function by the cognitive impairment and the behavioural disorders~     associated.~      Outpatients non-drug therapies represent a potential support that adapts to patient with an~     AD or mixed dementia, especially in their milder forms.~      The aim of the study is to evaluate the feasibility of a weekly rehabilitation's~     intervention at home and its acceptability by both the patient and the caregiver.~      The study of its efficiency in terms of autonomy will be the next step.~   "
104458|NCT01689818|"~     Poor sleep quality has been recognized as a major public health concern in the world. The~     prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated~     that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety,~     falls, or cognitive impairment in the elderly, which may compromise their daily activities~     function and quality of life.~      Recently, researches have demonstrated the associations between insomnia and endocrine~     system dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it~     is an important issue to improve sleep quality of the elders. The side-effects of~     pharmacological treatments and high-cost of cognitive behavior therapy limit their~     accessibility and effectiveness, and exercise training has been expected to provide an~     alternative intervention for insomnia. However, the long-term impact of insomnia on~     health-related fitness and metabolic function, and the effect of exercise training remain~     inconclusive. Therefore, the study hypothesis is that exercise training affect functional~     performance and quality of life in community-dwelling elderly with insomnia.~   "
104531|NCT01688869|"~     The purpose of the study is to gather information about patients with mild traumatic brain~     injury in order to develop guidelines for evaluation and treatment.~   "
104449|NCT01689935|"~     This research study aims to compare different methods for helping difficult to treat or~     scarring (cystic) acne, ALA-PDT and i-PDT.~      There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been~     reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses~     a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.~      Levulan® is applied directly to facial/back acne. This is the way that it is usually~     applied. Levulan® is left on the skin for three hours so the skin can absorb it. Next, the~     skin where the Levulan® was applied is exposed to a red light for activation.~      The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin~     through the skin pores to where the glands are. PDT destroys the glands reducing the acne~     lesion.~      Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure~     also has some side effects. Some of the side effects include pain, burning sensation during~     the procedure, and redness, tenderness, and swelling after the procedure.~      At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators~     developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT~     is aimed at reducing the side-effects of ALA- PDT.~      The difference between these two procedures is that i-PDT uses a light source that will~     prevent Levulan® accumulation in the normal skin surface. The investigators would like to~     find out if Levulan® will be placed only inside the sebaceous glands.~   "
104450|NCT01689922|"~     The primary objective of this study is to compare the effectiveness of standard for our~     practice postoperative physical therapy (PT) program to a PT program that incorporates lower~     body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy~     and fusion surgeries.~   "
104451|NCT01689909|"~     Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However,~     no studies have determined whether treating insomnia decreases the risk of suicidality. We~     have new data indicating that (1) the link between insomnia and suicidal ideation holds true~     in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are~     related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction~     of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal,~     depressed insomniacs may reduce suicide risk in a multi-site clinical trial.~   "
104452|NCT01689896|"~     This research is being done to see whether testosterone replacement in men who take~     opioid-based pain medications and have low testosterone levels will show improvement in pain~     tolerance, pain perception and quality of life.~      Some men who take opioid-based medications (narcotics) for pain develop low testosterone~     levels. Research has shown that low testosterone levels may make a person more sensitive to~     pain. This means that if a person with a painful condition develops low testosterone level~     as a result of his pain medications, he might become more sensitive to pain and so may need~     higher doses of pain medications for pain control.~      Testosterone is a male hormone that is important for sperm production and the development of~     male characteristics such as muscle mass and strength, fat distribution, bone mass and sex~     drive. Testosterone hormone replacement therapy has been used for decades to treat men with~     low testosterone levels (male hypogonadism). Testosterone replacement therapies are~     available in the form of an injection into the muscle, implants under the skin, oral~     capsules taken by mouth, topical gels applied to the skin, and skin patches.~      This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin.~     Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low~     testosterone levels).~      Men with non-cancer related pain who take opioid-based medications for pain and have low~     testosterone levels may join this study. (A low testosterone level is defined as early~     morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone~     of 50 ng/dl or less)).~   "
104453|NCT01689883|"~     The overall objective of the study is to test whether the use of small electrical currents~     to stimulate proprioceptors of the upper limb can result into enhancing the benefits of~     robotic-assisted therapy. The stimulation technique used is Stochastic Resonance (SR). In~     previous studies, it has been shown that SR has the effect of increasing afferent traffic~     from Golgi tendon organs and muscle spindles. This effect is referred to as sensory~     enhancement. Also, SR has been shown to improve the results of physical therapy in an~     animal model. The study is intended to explore the use of SR in stroke survivors.~   "
104454|NCT01689870|"~     This is an open label, two-phase study combining a dose escalation Phase 1 with a~     proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom~     treatment with ipilimumab is indicated.~      The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and~     the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor~     response assessed by the Immune-related Response Criteria.~      The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives~     are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.~   "
104455|NCT01689857|"~     Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment~     of surgical scars.~      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™~     Normal Randomization: Table of random number~   "
104456|NCT01689844|"~     The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies~     for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into~     practice for 120 African American participants who are on stable doses of antihypertensive~     medications. The first arm of our study offers minimal DASH-oriented dietary advice along~     with a food credit at a local supermarket where they make their own decision of what to eat.~     The second arm consists of a single one-hour session with a nutrition expert who provides~     choices and places an on-line order from a community grocery store (Santoni's Market) with~     targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in~     blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine~     potassium excretion, and self-report consumption of fruits and vegetables during the same~     period.~   "
104457|NCT01689831|"~     Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the~     standard tuberculin purified derivative (PPD-S2).~   "
104471|NCT01689649|"~     The purpose of this dose optimization study is to assess tolerability and efficacy of~     topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive~     or have failed one anti-epileptic drug (AED) treatment in monotherapy.~   "
104459|NCT01689805|"~     Atopic dermatitis is a common disease which affects about one million people in Finland at~     some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin~     and a defect in skin barrier function. The filaggrin protein plays a central role in the~     skin barrier function and studies indicate that about 30% of patients with atopic dermatitis~     have a mutation in the filaggrin gene. The aim of the study is to investigate whether a~     mutation in the filaggrin gene affects the clinical treatment outcome in patients with~     atopic dermatitis. If a mutation predisposes to a worse response to treatment, this could be~     examined and those patients with the mutation could be given extra treatment support for~     their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic~     population is studied in the control group.~   "
104460|NCT01689792|"~     To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium~     Picosulfate/Magnesium Citrate solution.~   "
104461|NCT01689779|"~     While vitamin D insufficiency [25(OH)D <30 ng/mL] is common in the general population,~     hypovitaminosis D may affect 40-80% of patients in the perioperative setting. Recent~     evidence also suggests that surgical stress may be associated with a 40% reduction in~     circulating 25(OH)D levels when compared to preoperative values. Moreover, the derangement~     in perioperative 25(OH)D levels may be sustained for up to 3 months after surgery. This~     finding has potential implications regarding modifiable risk factors for surgical site~     infections (SSIs), which account for nearly 40% of all nosocomial infections. On aggregate,~     SSIs result in 3.7 million extra hospital days per annum and an added burden of $1.6 billion~     in annual healthcare costs. A growing body of evidence suggests that robust postoperative~     immune function is associated with a lower risk of SSIs. At the same time, vitamin D is~     increasingly recognized as a key regulator of the innate and adaptive immune systems. Yet,~     optimization of perioperative vitamin D status remains grossly understudied. Although our~     overarching aim is to study the impact of vitamin D status on SSIs, the focus of the current~     investigation is to determine whether the administration of a bolus oral dose of~     cholecalciferol (vitamin D3) in the preoperative setting alters vitamin D status in the~     perioperative setting (compared to a placebo). The investigators elected to conduct the~     current study in patients who will undergo colorectal surgery since these patients are~     historically at higher risk of developing SSIs and therefore would be ideal for future~     investigations.~   "
104462|NCT01689766|"~     Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to~     identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma~   "
104463|NCT01689753|"~     The aim of the trial was to assess whether use of the TEGO connector was able to reduce the~     incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related~     bacteremia (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs~     controls receiving trisodium citrate 46.7%.~   "
104464|NCT01689740|"~     This study will examine symptoms of posttraumatic stress disorder (PTSD) in people before~     and after psychotherapy with 25 mg followed two hours later by 12.5 mg or 125 mg followed~     two hours later by 62.5 mg methylenedioxymethamphetamine (MDMA) in order to see if this~     treatment is safe and can help reduce PTSD symptoms. Participants will be randomly assigned~     to one of the two doses of MDMA given in two sessions scheduled three to five weeks apart.~     They will prepare for the sessions before the first one and they will work with~     psychotherapists in conventional (non-drug assisted) psychotherapy afterwards. Symptoms of~     PTSD and depression, sleep quality and general psychological health will be measured at the~     start of the study and 2 and 12 months after the second session.~   "
104465|NCT01689727|"~     Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This~     Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a~     ligand (EC20) designed to bind to the folate receptor. The study is designed as an~     open-label, baseline-controlled study.~   "
104466|NCT01689714|"~     The folate receptor is overexpressed in many types of cancer, including ovarian and~     endometrial cancer, and the level of folate receptor expression increases with the stage of~     the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic~     radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may~     provide an effective method to determine folate receptor-positive (FR+) target tumors,~     thereby assisting in the identification of those patients who may benefit from~     folate-targeted therapy.~   "
104467|NCT01689701|"~     The investigators performed a double-blind parallel study in a group of Subjects Showing~     Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.~     Endoscopic observations were performed before and 4 weeks after the treatment, and the cure~     and improvement rates were investigated.~   "
104468|NCT01689688|"~     The purpose of this study is to evaluate serial changes of neointimal coverage after~     everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.~   "
104469|NCT01689675|"~     Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health,~     quality of life and societal productivity. Early intervention for pain following acute MSIDs~     may prevent secondary complications of chronic pain, disability, reduced quality of life or~     lost productivity. The investigators goal is to evaluate the efficacy of a computer-based~     self-management intervention for reducing pain and improving function in persons treated in~     on-site physical rehabilitation centers.~      The specific aims are:1) evaluate the efficacy of a computer-based self-management~     intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2)~     determine long term impact during a six month follow-up period; and 3) determine whether~     reductions of pain and improved function translate into reductions in lost work time days~     away from work, restricted work days, worker's compensation costs and re-injury rates during~     the 6 month follow-up.~      Persons with sprain/strain injuries at risk for poor pain control will randomized to either:~     1) control condition - standard care in the rehabilitation center plus computer exposure or~     2) standard care plus computer-based self-management pain intervention. Assessment will be~     at baseline, treatment completion, 3 and 6 months. The primary outcome measures are~     self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are~     days away from work, restricted work days worker's compensation costs and re-injury rates.~     The investigation will also provide unique and valuable information regarding patients~     acceptance and use of computer-based interventions following acute injury. By establishing~     the utility and efficacy of computer-based pain management interventions for MSID the~     investigators have the potential to improve the health and quality of life of persons with~     injuries, improve productivity and develop new methods for health care delivery.~   "
104470|NCT01689662|"~     The folate receptor (FR) is overexpressed by many different cancer types, including renal~     cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent~     could provide an effective method to identify folate receptor-positive (FR+) cancer patients~     that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly~     suspected metastatic renal cell carcinoma with at least one target lesion detected by a~     diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this~     study.~   "
104473|NCT01689623|"~     The purpose of this study is to evaluate effects of steady-state concentrations (constant~     concentration of medication in the blood) of TMC435 on the single dose pharmacokinetics~     (what the body does to the medication) of atorvastatin, the active metabolites ortho- and~     parahydroxylated atorvastatin, simvastatin and the active metabolite simvastatin acid.~     Plasma hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitory activity after a~     single dose of atorvastatin or simvastatin, either alone or in combination with TMC435 will~     be also evaluated.~   "
104474|NCT01689610|"~     The purpose of this non-interventional study is to collect data on the efficacy and safety~     of Nab-Paclitaxel in the routine application.~   "
104475|NCT01689597|"~     This pilot study intends to establish the efficacy of 2 different doses of epidural morphine~     for pain management after perineal trauma when using multimodal analgesia as well as the~     feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal~     delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural~     morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid~     consumption for breakthrough pain in the first 24 hours.~   "
104476|NCT01689584|"~     The aim of the COVAR project is to classify reliably a maximum of VUS of the French database~     in order to use them for the genetic counseling. The results obtained through this study~     will have a major impact on clinical management of the patients and their families~     conducting in some cases to propose a prophylactic surgery.~   "
104477|NCT01689571|"~     The study is designed to look at the safety, tolerability and efficacy of 2 different doses~     of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once~     a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF~     6001 after an allergen challenge.~   "
104478|NCT01689558|"~     1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance~     with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced~     nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined~     Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to~     treat the local advanced nasopharyngeal darcinoma.~   "
104479|NCT01689545|"~     The purpose of this study is to determine whether a combined individual and structural level~     stigma reduction intervention is effective in reducing high risk injecting and sexual~     behaviors among HIV positive injecting drug users.~   "
104480|NCT01689532|"~     The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single~     therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA)~     who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).~   "
104481|NCT01689519|"~     To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared~     with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients~     with unresectable locally advanced or metastatic melanoma, as measured by progression-free~     survival (PFS), assessed by the study site investigator.~   "
104482|NCT01689506|"~     This clinical study compares two fluid resuscitation treatments in patients suffering from~     burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be~     administered as infusion solutions. It will be evaluated whether Volulyte® is effective and~     safe, and provides any benefit.~   "
104483|NCT01689493|"~     The purpose of this study is to assess the effectiveness of an adherence protocol~     intervention among stented patients to improve adherence to antiplatelet therapy (primary~     endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular~     events (ACS, stent thrombosis, re- hospitalization and coronary angiography,~     revascularization, all-cause mortality) and its cost-effectiveness.~   "
104484|NCT01689480|"~     It is now accepted that physical activity is not deleterious in myopathies, including~     muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),~     aerobic training has been reported to be associated with physiological and functional~     positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup~     et al. (2007) studies suggest that the combination of endurance and strength trainings is~     even more relevant. However, only a few controlled and randomized studies have been~     conducted on this topic and the impact of such training programs on skeletal muscle~     regenerative capacities has not been addressed yet. Moreover, due to the fact that training~     programs are mainly performed on short-term supervised periods, there is a lack of knowledge~     regarding long-term effects, patient's autonomy and whether or not practice of regular~     exercise can be maintained in patient's daily life. Also, only a few experiments report an~     integrative view of potential benefits of such programs on functional, biological and~     quality of life.~   "
104485|NCT01689467|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue~     recovery after exercise. The investigators measured fatigue recovery parameters , including~     lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood~     pressure.~   "
104486|NCT01689454|"~     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the~     live birth rate in IVF patients with a previous history of pregnancy loss.~      Couples requiring IVF treatment and with a past experience of implantation failure will be~     included in the study.~      Controlled ovarian stimulation protocol will consist of an agonist down regulation and~     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or~     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2~     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio,~     Måløv, Denmark) will be adopted throughout the culture period. In the control group,~     inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1,~     Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.~      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1~     respectively. The endometrial support will be the same in the two groups.~   "
104567|NCT01688401|"~     The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in~     the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of~     the chemotherapeutic agent enhances the regional distribution of the drug, thereby~     increasing the local delivered dose while minimizing systemic toxicity. It also provides a~     treatment option for these patients at the time of tumor recurrence.~   "
104487|NCT01689441|"~     Observational studies among critically ill patients have shown strong associations between~     vitamin D deficiency and adverse outcomes, including increased length of stay, infection,~     and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse~     outcomes or whether it is simply a biomarker of severity of illness or overall health~     status. However, vitamin D plays a key role in host defense, largely by stimulating~     production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis~     that administration of activated vitamin D (calcitriol) will increase serum levels of~     cathelicidin.~   "
104488|NCT01689428|"~     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the~     live birth rate in IVF patients with a previous history of pregnancy loss.~      Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical~     pregnancy will be included in the study.~      Controlled ovarian stimulation protocol will consist of an agonist down regulation and~     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or~     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2~     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio,~     Måløv, Denmark) will be adopted throughout the culture period. In the control group,~     inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1,~     Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.~      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1~     respectively. The endometrial support will be the same in the two groups.~      The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a~     25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As~     secondary outcome the investigators will assume a 5% of increment in ongoing implantation~     rate after 12 weeks in the group with EmbryoGen medium.~   "
104489|NCT01689415|"~     It is known, that hypertension is the major risk factor of stroke and recurrent stroke.~     Blood pressure reduction - together with antithrombotics - remain crucial in stroke~     prevention.~      This pilot study will examine the effect of renal nerve denervation in patients with~     treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24~     hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6~     and 12 months after the procedure.~   "
104490|NCT01689402|"~     What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter~     the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not~     yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to~     detemine the biochemsty in the border zone and structural MRI for vascular malformation. We~     repeat structural MRI after 8 weeks.~   "
104491|NCT01689389|"~     The aim of the study is to describe patient characteristics (demographic and clinical) and~     the patterns of use of Quetiapine XR in patients receiving the drug for the first time in~     real-life practice regardless the final diagnosis.~   "
104492|NCT01689376|"~     The purpose of this Managed Access Program is to provide regorafenib to patients diagnosed~     with metastatic and / or unresectable GIST who have progressed after standard therapy.~   "
104493|NCT01689363|"~     This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers~     using an intradermal skin test.~   "
104494|NCT01689350|"~     The purpose of this study is to compare the genotype-based personal prescription of~     cyclophosphamide with the traditional prescription.~   "
104495|NCT01689337|"~     This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to~     evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast~     growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture~     (MFx) surgery for cartilage injury of the knee.~      Primary Objectives~        -  To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as~          adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in~          the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of~          cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery~        -  To evaluate the safety profile of Sprifermin (AS902330) when administered~          intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage~          injury of the knee~      Secondary Objectives~        -  To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to~          MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI~          measurement~   "
104496|NCT01689324|"~     This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced~     diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose~     in adolescents in Japan.~      Primary Objective:~        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in~          Japanese adolescents~      Secondary Objective:~        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese~          adolescents.~   "
104497|NCT01689311|"~     The purpose of this study is to compare the ability of an isolated sample of uterine muscle~     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs~     studied--uterotonics--are typically used to contract the uterus when a pregnant patient~     continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin,~     ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is~     unknown.~      The investigators will be testing isolated uterine muscle samples to increasing~     concentrations of these four drugs in three patient populations: non-laboring, laboring~     without exogenous oxytocin augmentation, and laboring with oxytocin augmentation.~     Contractile measures will be measured and compared between all groups. The investigators~     hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented~     laboring patients, and all four drugs will induce different patterns of contractions.~   "
104511|NCT01689129|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese~     patients with type 1 diabetes mellitus~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting~     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose~     (SMPG) profile.~      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of~     hypoglycemia~   "
104512|NCT01689116|"~     This is a single-center, multiple-dose, randomized, double-blind, double-dummy,~     placebo-controlled, active-comparator, parallel study in healthy volunteers.~   "
104498|NCT01689298|"~     The purpose of this study is to compare the ability of an isolated sample of uterine muscle~     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs~     studied--uterotonics--are typically used to contract the uterus when a pregnant patient~     continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a~     desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to~     clinicians as a replacement for oxytocin directly after certain types of Cesarean section.~      The investigators will be testing isolated uterine muscle samples after pre-treatment with~     oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin.~     Contractile measures will be measured and compared between all groups. The investigators~     hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and~     carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns~     of contractions.~   "
104499|NCT01689285|"~     A new paediatric formulation (oral liquid) has been developed for flexible and accurate~     dosing of valacyclovir in children. To establish the bioavailability of this new~     formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir~     tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid~     will be measured and compared to the tablet.~   "
104500|NCT01689272|"~     The purpose of the study:~        -  To estimate the role of morphological, clinical, biochemical and imaging studies at~          stages of kidney transplantation (medical therapy, explantation, preservation,~          transplantation).~        -  To improve the ways of preserving optimal functional parameters of renal transplants.~   "
104501|NCT01689259|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102~     2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased~     dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to~     compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of~     TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg~     tablets).~   "
104502|NCT01689246|"~     The purpose of this study is to determine the safety and efficacy of TRx0237 in the~     treatment of subjects with mild to moderate Alzheimer's Disease.~   "
104503|NCT01689233|"~     The purpose of this study is to determine the safety and efficacy of TRx0237 in the~     treatment of subjects with mild Alzheimer's Disease.~   "
104504|NCT01689220|"~     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy~     in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).~   "
104505|NCT01689207|"~     This is a randomised, double-blind, 3-part study designed to investigate the safety and~     tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI,~     when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following~     single administration, and following multiple administrations of ATM-AVI in healthy male and~     female (females of nonchildbearing potential) volunteers both young and elderly.~   "
104506|NCT01689194|"~     This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy~     using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators~     try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.~   "
104507|NCT01689181|"~     Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is~     a core component of negative symptoms. It has been suggested that the physiopathology of~     apathy is not a single entity but may be multiple, depending on which specific process or~     macrofunction is disrupted during completion of GDB. In line with this notion, Levy and~     Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing:~     'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been~     associated with executive dysfunction, functional impairment and poor outcome. However, the~     neurobiological underpinnings of apathy in schizophrenia are poorly understood.~      Primary objective: confirm that chronic schizophrenic patients are apathic compared to~     healthy volunteers~      Secondary objectives:~        -  investigate if apathy is related to a particular aspect of the disease (i.e. negative,~          positive symptomatology and/or deficit form)~        -  investigate if apathy correlates with executive dysfunction~        -  investigate if apathy is associated with a specific mechanism using an experimental~          task specially designed to investigate the different mechanism (i.e. 'a-motivation',~          'cognitive inertia', and 'uncoupling')~        -  investigate if there is a volumetric abnormality affecting the executive system in~          apathic schizophrenic patients~        -  link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia~          circuits according to a specific subtype of apathy in the apathic schizophrenic group~   "
104508|NCT01689168|"~     Tobacco use is the number one killer of Americans today. Most current smokers have tried and~     failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and~     withdrawal from smoking can lead to physical symptoms such as irritability, anxiety,~     nervousness, depression and insomnia.~      This study will examine the effects of tobacco cessation counseling and chiropractic~     treatments on smokers who desire to quit.~   "
104509|NCT01689155|"~     This is a passive-surveillance study that will accrue subjects for surveillance. For each~     accrued subject, surveillance for outcomes will continue for six months following the first~     dose. If a second dose is given within that time, then surveillance will be continued for~     six months following the second dose.~      Observational Objective:~        -  To describe and characterize adverse events occurring after vaccination with Menactra~          vaccine.~   "
104510|NCT01689142|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese~     patients with type 2 diabetes mellitus.~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting~     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose~     (SMPG) profile.~      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of~     hypoglycemia~   "
104513|NCT01689103|"~     This project is studying the role of the therapeutic alliance between the therapist and~     patient in the outpatient treatment of persons with alcohol use disorders.~   "
104517|NCT01689051|"~     Diabetes and high blood pressure are risk factors for developing heart disease. An increase~     in the number of diabetes patients is expected. This increases the number of patients with~     heart disease, and since the vast majority with diabetes die from heart disease, it is~     extremely important to investigate how these diseases can be prevented and treated.~      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can~     expand blood vessels, thus lowering blood pressure, but it is not known whether the effects~     is found in humans, which we will investigate.~      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is~     solely due to increased insulin production, weight loss associated with GLP-1 intake or~     GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate~     whether GLP-1 enhances the absorption of sugar in the leg.~      The investigators also examines whether these effects are greater in people with diabetes~     then in healthy.~   "
104518|NCT01689038|"~     Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.~   "
104519|NCT01689025|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with~     systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.~   "
104520|NCT01689012|"~     This study seeks to evaluate the effects of facial exercises on aging of the face.~   "
104521|NCT01688999|"~     Background:~      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is~     approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian~     tumors respond to it. Researchers want see if cabozantinib can be a safe and effective~     treatment for urothelial cancer.~      Objectives:~      - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced urothelial cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor tissue samples will also be collected. Imaging studies~          will also be performed.~        -  Participants will take cabozantinib by mouth once per day on each day of a 28-day~          cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drug for as long as their cancer does not~          worsen and side effects are not too severe.~   "
104522|NCT01688986|"~     The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to~     gather health, family history of disease, environmental exposures and lifestyle data on~     adult EPR subjects. The EPR is a registry established to collect and store DNA samples from~     20,000 volunteers from North Carolina and to serve as a resource to scientist investigating~     genotype-driven translational research of chronic conditions. Under this new protocol, we~     will administer a health and exposures survey to all EPR subjects. The information collected~     in the survey will be used to better characterize the EPR population thus making it more~     useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the~     survey will help researchers develop hypotheses, design follow-up studies, and select~     appropriate subjects.~      The survey will be administered to EPR subjects using a modified version of the Dillman~     Total Design Method (TDM) for surveys. This method requires following specific~     time-dependent steps for survey administration that incorporate both self- and phone~     administration and other types of phone and mail contact. The goal of TDM is to maximize~     subject response rates.~   "
104523|NCT01688973|"~     This randomized phase II trial studies how well tivantinib with or without erlotinib~     hydrochloride works in treating patients with metastatic or locally advanced kidney cancer~     that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
104524|NCT01688960|"~     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/~     SAR307746) in combination with aflibercept (ziv-aflibercept in the U.S.)~   "
104525|NCT01688947|"~     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels~     of V116517 versus placebo.~   "
104526|NCT01688934|"~     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels~     of V116517 versus placebo.~   "
104527|NCT01688921|"~     The purpose of this study is to determine if the administration of a seasonal flu vaccine~     using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and~     syringe administration, as measured by laboratory tests of immune response.~   "
104528|NCT01688908|"~     To evaluate the efficacy of endoscopy screening on esophageal cancer (EC) and determine the~     most cost-effective strategy of endoscopy screening in high risk population of China, 668~     villages of Hua county, a high risk area of esophageal cancer, were randomized into~     screening arm and control arm in a ratio of 1:1 and the total sample size is over 30,000~     (~16,000 per group). Participants in the screening arm will accept standard endoscopy~     examination to detect early esophageal cancer and no screening were designed in control arm.~     The incidence of advanced EC and EC-specific mortality will be compared within the two~     groups to test the hypothesis that endoscopy screening would detect early stage cancer and~     the incidence of advanced stage EC and EC-specific mortality will be lower than control~     group. Cost-effectiveness analysis will also be conducted to find the most cost-effective~     strategy of endoscopy screening in rural China.~   "
104529|NCT01688895|"~     The initial objective of this protocol is to assemble a well-documented group of patients~     with confirmed diagnoses of the erythropoietic protoporphyrias, including autosomal~     recessive Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) for~     clinical, biochemical, and genetic studies. The long-term objectives are (1) to conduct a~     longitudinal investigation of the natural history, complications, and therapeutic outcomes~     in people with erythropoietic protoporphyria, (2) to systematically investigate the~     psychological effects of the erythropoietic protoporphyrias on children and adults, and (3)~     to investigate the correlation between the identified genotypes and the resulting clinical~     presentation, also determining the possible interaction of other genetic markers.~   "
104530|NCT01688882|"~     To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous~     pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is~     broken down by the body and the impact it has on different blood and tissue markers will~     also be explored.~   "
104532|NCT01688856|"~     Impaired arm and hand function is one of the most disabling and most common consequences of~     stroke. The Investigators have developed Contralaterally Controlled Functional Electrical~     Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for~     improving the recovery of hand function after stroke. The purpose of this study is to~     maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific~     aims and hypotheses are as follows:~      AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity~     limitation.~      Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper~     limb impairment and activity limitation measures than those treated with dose-matched~     Arm+Hand Cyclic NMES.~      AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.~      Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in~     upper limb impairment and activity limitation than those treated with Hand CCFES.~      AIM 3: Describe the relationship between treatment effect and time elapsed between stroke~     onset and start of treatment.~      Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better~     outcomes.~   "
104533|NCT01688843|"~     The objective of this study is to gather data to establish the safety, performance and~     effectiveness of the INGEVITY pace/ sense leads.~   "
104534|NCT01688830|"~     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI~     655075 following intravenous administration of single rising doses of BI 655075 when~     administered alone and after administration of dabigatran.~   "
104535|NCT01688817|"~     The purpose of this study is to assess the impact of physician's counseling on participation~     and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening~     program~   "
104536|NCT01688804|"~     Greater time spent in sedentary behaviors, independent of physical activity level, can~     increase risk of morbidity and mortality. Objective assessments indicate that bariatric~     surgery patients spend large amounts of time in sedentary behaviors. The present study is~     the first to test whether a mobile health (mHealth) approach that employs widely adopted~     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible~     and acceptable method of reducing sedentary time in these patients and other obese~     populations.~   "
104537|NCT01688791|"~     This trial will be conducted in three parts. Part A is a dose escalation trial followed by a~     dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The~     primary hypothesis of this trial is that administration of vintafolide in combination with~     carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation,~     pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination~     of the maximum single tolerated dose of vintafolide and to evaluate the effect of this~     single maximum dose on the QTc interval. Part C is a weekly dose escalation trial of~     vintafolide followed by a dose confirmation. The primary hypothesis of this part is that~     weekly vintafolide has acceptable safety and tolerability in participants with advanced~     cancers.~   "
104538|NCT01688778|"~     The aim of the study is to investigate the effect of telemedicine among the group of~     type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the~     patients with regards to vulnerability and social resources and to determine wich groups~     benefit the most from telemedicine.~   "
104539|NCT01688765|"~     The purpose of this study is to investigate the structural, functional and chemical brain~     abnormalities in patients with first episode psychosis and assess the evolution of these~     abnormalities during the course of the disease.~   "
104540|NCT01688752|"~     This is a prospective cohort study assessing measures of cardiometabolic status, body~     composition, IR and GH response to stimulation after therapy in children (age 7-21 years)~     treated for ALL. Patients and sibling controls will be recruited from the Pediatric~     Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.~   "
104541|NCT01688739|"~     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated~     in healthy subjects and migraine patients. As part of the secondary objectives, this study~     will be conducted to characterize the pharmacokinetics (PK) profile of AMG 334 after single~     SC or IV doses in healthy subjects and migraine patients as well as to characterize the~     effect of AMG 334 on the capsaicin-induced increase in dermal blood flow after single SC or~     IV doses in healthy subjects and migraine patients.~   "
104542|NCT01688726|"~     The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing~     the tear film of dry eye patients with an unstable tear film.~   "
104543|NCT01688713|"~     Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung~     cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are~     important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal~     growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the~     blood-brain barrier and show promising antitumor activity against brain metastases from~     NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of~     tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of~     drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR~     inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the~     Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It~     is a challenge whether the further dose escalation of Icotinib will enhance its~     concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the~     investigators examine the therapeutic effect and side-effect of double dose of Icitinib in~     treating patients with brain metastases from NSCLC who have suffered from the failure of~     conventional dose treatment.~   "
104544|NCT01688700|"~     A higher percentage of radical resection is reported in studies using neoadjuvant~     chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant~     chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a~     humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The~     concurrent trial is a clinical phase II trial designed to assess the efficacy of the~     combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in~     patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its~     side-effect and toxicity~   "
106940|NCT01657136|"~     The aim of this study is to prospectively compare the effectiveness and safety of ivabradine~     and beta-blockers in the treatment of inappropriate sinus tachycardia.~   "
104545|NCT01688687|"~     Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and~     high-magnification imaging of the gastrointestinal epithelium, which is comparable to~     histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and~     differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures.~     However, to date there are limited data exploring the application of pCLE to gastric~     lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy~     with that of pCLE using the final specimens obtained from endoscopic resection as a~     reference standard. The aims of this study were (1) the accuracy of pCLE compared to~     conventional forceps biopsy using histopathology results following endoscopic resection as a~     reference, and (2) comparison of real time in-vivo pCLE diagnosis with that of blinded~     off-line pCLE diagnosis, and off-line interobserver agreement.~   "
104546|NCT01688674|"~     NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms~     receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during~     the 72 hours of admission in Special Care Unit- Mulago Hospital.~      ALTERNATE HYPOTHESIS~      • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30%~     compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit~     in the first 72 hours of admission.~   "
104547|NCT01688661|"~     The sniffing position has been regarded as a standard position for direct laryngoscopic~     view. This study evaluated the effects of the age and gender on the advantage of the~     sniffing position compared with simple head extension for laryngeal view during direct~     laryngoscopy.~   "
104548|NCT01688648|"~     The aim of the present study is to compare the antiarrhythmic and myocardial protective~     effect between lidocaine, dexmedetomidine, and their combined infusion in subjects~     undergoing coronary artery bypass graft.~   "
104549|NCT01688635|"~     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of~     LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of~     LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each~     period, a single injection will be administered before undergoing a euglycemic clamp that~     lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects~     will be documented. Study participation is expected to last up to 14 weeks.~   "
104550|NCT01688622|"~     Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation~     related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we~     examine the circulating levels of theses adipokines in the subjects with or without~     metabolic syndrome. Furthermore, we tried to clarify the effect of exercise on the~     circulating these adipokines.~   "
104551|NCT01688609|"~     This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab,~     paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some~     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or~     carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
104552|NCT01688596|"~     The primary objective of this study is to assess if injection of local anesthetic to the~     laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain~     after surgery.~   "
104553|NCT01688583|"~     The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix~     in chronic non-cancer pain.~   "
104554|NCT01688570|"~     While baseline weakness is clearly an important factor that contributes to disability post~     stroke, neuromuscular fatigue (the acute reduction in force production) of the paretic~     musculature likely compounds strength deficits and further exacerbates disability. The~     proposed study aims to improve our understanding of the mechanisms of neuromuscular fatigue~     in people post stroke in order to optimize strength training. In healthy individuals, both~     central (neural) and peripheral (muscle) factors are determinants of neuromuscular fatigue,~     but preliminary data from our laboratory suggests a greater contribution of central~     components to neuromuscular fatigue in the paretic musculature. Although cortical pathways~     are clearly disrupted post stroke, it is likely that brainstem pathways, known to have~     neuromodulatory effects on spinal motor circuitry, are more involved in the sustaining of~     force in the paretic leg, compared to the non-paretic and control legs. Therefore, the~     purpose of this proposal is to examine the role of descending neuromodulatory pathways of~     the brainstem in neuromuscular fatigue post stroke (Aim 1) and to correlate~     brainstem-related changes in neuromuscular fatigue to walking function (Aim 2). The~     investigators propose that stroke survivors' decreased capability to sustain force overtime~     results from the diminished ability of spinal motoneurons to respond to brainstem~     neuromodulatory inputs (serotonin (5-HT) and norepinephrine (NE)). Aim 1 will quantify~     stroke-related decreases in motor output sensitivity to a 5-HT and NE reuptake inhibitor~     (SNRI), serotonin antagonist, or placebo during sub-maximal intermittent fatiguing knee~     extension contractions. If motoneurons are desensitized to descending monoamines in chronic~     stroke patients, then they will be less sensitive to the effects of drugs that increase~     monoamine levels. The investigators predict that in response to the SNRI or serotonin~     antagonist, the paretic leg will show less change in time to task failure and a smaller~     reduction in strength as compared to the non-paretic and control legs. For Aim 2, the~     investigators predict that stroke subjects with the highest walking function will~     demonstrate the greatest fatigue-related changes in response to the SNRI. This proposal~     adopts an innovative model of motor impairment post stroke by including the role of~     subcortical structures in neuromuscular fatigue.~   "
104555|NCT01688557|"~     The trial will compare results of screening colonoscopy performed by means of conventional~     colonoscopy and using new visualisation techniques during endoscopic examination.~        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning~          (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band~          imaging (NBI) will be used for innovative colonoscopies~        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used~          for conventional colonoscopies Endoscopists will archive all images and establish~          presumptive diagnosis based on the results of different visualisation techniques. All~          endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all~          pathological lesions will be performed to establish final diagnosis. The main outcome~          measure is diagnostic accuracy of innovative colonoscopy in comparison with~          conventional technique.~   "
104556|NCT01688544|"~     Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic~     polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and~     pharmacodynamics of Ilaprazole.~   "
104557|NCT01688531|"~     Exploratory, international, multi-centre, randomized, investigator blinded study in acne~   "
104558|NCT01688518|"~     This will be a randomized, single-blind, active-controlled, two-period crossover study in~     adult volunteers to compare the duration and depth of anesthesia between Synera® and~     Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a~     Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.~   "
104559|NCT01688505|"~     Hypertension in midlife is an independent risk factor of late life cognitive dysfunction or~     dementia. Chronic hypertension cause vascular damage and cerebral ischemia, which ultimately~     gives rise to the cognitive dysfunction or dementia.~      A recent study showed that high visit-to-visit variability in clinic systolic blood pressure~     (BP) was a strong independent predictor of stroke. This finding suggests that high clinic~     systolic BP variability itself as well as chronic hypertension may cause vascular damage and~     cerebral ischemia. Therefore, high clinic SBP variability may be also an independent risk~     factor of cognitive dysfunction or dementia.~      Vascular damage leads to the diminished autoregulatory capacities of cerebral arteries. The~     brain with the reduced autoregulatory capacity may be more vulnerable to BP fluctuation.~     Therefore, high BP variability may be more harmful in patients with damaged vessels (for~     example, in patients with cerebral small vessel disease).~      Previous data about BP variability and cognition revealed very controversial. Some studies~     showed poor cognition in patients with high BP variability, but others did not.~      The previous studies were mostly based on cross-sectional designs, and performed in~     small-sized heterogeneous population for primary prevention. The harmful effect of high BP~     variability may be clearer in the population with damaged vascular bed, such as cerebral~     small vessel disease. The previous studies usually used ambulatory BP monitoring (ABPM).~     However, recent data suggested that variability in BP on ABPM may be a weaker predictor of~     vascular events than be visit-to-visit variability in clinic BP.~      The investigators sought to find whether high visit-to-visit variability in clinic BP is~     related with poor cognitive function in patients with cerebral small vessel disease.~   "
104560|NCT01688492|"~     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab~     with abiraterone acetate plus prednisone has on the patient and the prostate cancer.~     Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone~     stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for~     patients with prostate cancer.~      Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This~     study will test how they work together. Each patient will receive abiraterone acetate,~     prednisone and ipilimumab.~   "
104561|NCT01688479|"~     Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing~     postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry~     and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez~     et al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type~     of surgery and previous chemotherapy, are factors that might impact on the risk for ARSR~     together with patient-related factors such as body mass index (BMI), smoking status and~     previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of~     the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown~     that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and~     itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care~     recommendations which included application of a thin layer of Essex® cream, a non-perfumed~     aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The~     effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in~     patients with breast cancer were investigated in a randomized clinical trial (Pommier et~     al., 2004). Patients in the experimental group, treated with calendula cream had a~     statistically significant lower incidence of severe ARSR, pain and treatment interruptions~     in comparison with the patients in the control group, treated with trolamine.~      The purpose of this blinded, randomized clinical trial is to compare two topical agents,~     Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe~     acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast~     cancer.~      Patients were instructed to apply a thin layer of the assigned cream twice a day, starting~     at the onset of RT and continue until two weeks after termination, or until the ARSR is~     healed. The application should include the whole treatment area including the armpit and~     shoulder/back area in patients treated with modified radical mastectomy. Patients are also~     advised to not apply the cream within two hours before the RT in order to avoid possible~     build-up effect. Daily wash with perfume free soap and tap water are recommended and~     patients are advised to refrain from use of other topical agents in the irradiated area.~      The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR),~     assessed with the Radiation Therapy Oncology Group/The Organization for Research and~     Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at~     follow-up.~      Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire~     (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the~     irradiated area (visual analogue scale). Patients' experiences and adherence to the topical~     agents are also evaluated.~      A total of 400 patients are required to detect a true absolute reduction in the proportion~     of patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the~     experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of~     90%. With this sample size, 95% confidence intervals for the difference in proportions are~     estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target~     size has been set to 420 patients.~   "
104562|NCT01688466|"~     Background:~      - Pomalidomide is a drug that alters the body s immune response. It may help people who have~     chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when~     immune cells in the transplant try to attack tissues in the person who received the~     transplant. GvHD is not easy to treat, and often does not respond to standard treatments.~     Researchers want to see if pomalidomide is a safe and effective treatment for GvHD.~      Objectives:~      - To test the safety and effectiveness of pomalidomide for GvHD that has not responded to~     standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have GvHD that has not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. A lung function test and imaging studies will also be~          given.~        -  Participants will take pomalidomide capsules once a day for 4-week periods called~          cycles.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Saliva~          samples and skin and mouth tissue biopsies will also be collected during treatment.~        -  Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side~          effects are too severe. If the GvHD has improved at the end of the six cycles,~          participants may be able to continue to take pomalidomide for up to six more cycles.~   "
104563|NCT01688453|"~     Background: The prevalence of overweight and obesity continues to increase in socially less~     advantaged populations but is stabilizing even is decreasing in socially more advantaged~     populations. The PRALIMAP trial highlighted the effectiveness of structured screening and~     care management in decreasing the prevalence of overweight and obesity in high school~     adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened~     care management (CM) for socially less advantaged adolescents in school in the short and~     long term has an equivalent effect as a standard-CM on decreasing the prevalence of~     overweight and obesity among socially advantaged adolescents.~      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight~     and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35~     state-run schools of the Vosges department (northeastern France) for the academic years~     2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as~     advantaged are allocated to the standard-CM and those less advantaged are randomized to~     standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr~     each performed in high school and supervised by a healthcare mobile team specialised in~     overweight and obesity care management for adolescents. The strengthened-CM consists of 5~     collective sessions with the same standard operating procedure as the standard-CM with~     supplementary interventions between each session: strengthened solicitation with the~     adolescent and the family, peer-led educational sessions, motivational interviews, financial~     support for physical activity practice, cooking classes and multidisciplinary consultation~     meetings. Data on sociodemographics, anthropometrics, physical activity and mental health~     are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at~     the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1~     year after the intervention=T2). Process evaluation data are also collected during the~     trial.~      Expected results: To confirm the effectiveness of overweight CM for adolescents in a school~     setting and to highlight or not the effectiveness of specific strengthened interventions~     adapted for socially less advantaged adolescents to maintain social equality in access to~     overweight care.~   "
104564|NCT01688440|"~     When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube~     to assist their breathing and/or a nasal canula. The investigators must periodically~     irrigate the ET tube to prevent them from being plugged up by secretions. The investigators~     also, due to the drying effects of nasal canula, periodically moisten the nasal passages of~     babies. Presently 0.9% saline is the solution being used for moistening of the ET tube,~     nose, as well as oral cares will infant is not eating. However, scientists have recently~     learned that saline can destroy the body's natural antibacterial properties in the windpipe,~     nose, and mouth.~      The investigators have developed a new solution to be used in place of saline for~     endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after~     the natural fluid in the windpipe, nose, and mouth.~      Study Hypothesis:~        1. Patients who receive ETCare will have no increase in adverse events related to its~          administration, compared with 0.9% saline.~        2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where~          pathogens are reported.~        3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where~          leukocytes are reported.~        4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental~          oxygen.~   "
104565|NCT01688427|"~     This research is being done to test whether mobile technology will reduce possible~     communication barriers between women and their home visitor; to improve assessing for health~     problems that could affect their pregnancy; to help in the delivery of information and~     actions to improve the health of the woman and their child.~   "
104566|NCT01688414|"~     This pilot clinical trial studies imaging during surgery in diagnosing patients with~     prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,~     bladder, or kidney cancer~   "
104568|NCT01688388|"~     This clinical trial is being conducted to find out the effects (good and bad) of giving the~     full radiation treatment for breast cancer as a single dose of radiation during surgery for~     breast cancer. This single fraction intraoperative radiotherapy with electrons will study~     the toxicity, local control and cosmetic outcome.~   "
104569|NCT01688375|"~     ABSTRACT:~      In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this~     study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on~     patients with obstructive jaundice after surgical or endoscopic treatment.~      Patients with obstructive jaundice will be divided into two groups: (A) test group in which~     will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical~     procedure and will last fourteen days, and (B) control group.~      Serum-testing will include determination of bilirubin, alanine transaminase, aspartate~     transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol~     levels. These parameters will be determined one day prior endoscopic or surgical procedure,~     and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or~     surgical intervention.~      Our hypothesis is that patients with obstructive jaundice under treatment with~     ursodeoxycholic acid will have better outcome than patients in control group.~   "
104570|NCT01688362|"~     The purpose of this study is to further define the optimal non-surgical treatment strategy~     for partial thickness rotator cuff tears. The specific aim of this study is to determine the~     outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or~     platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be~     randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon~     healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be~     followed for one year to determine the outcomes for each treatment. The hypothesis is that~     there is no difference in healing rate or functional outcomes in patients treated with~     corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator~     cuff tears.~   "
104571|NCT01688349|"~     The purpose of this trial is to investigate the impact of cortisol on adipose tissue~     functions, distribution and morphology. Patient with endogenous blood cortisol excess~     exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading~     to visceral obesity and features of the metabolic syndrome. The aims of this study will be~        -  to compare the pattern of gene expression between visceral and subcutaneous adipose~          tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;~        -  to compare these patterns of gene expression with those of two control populations:1/~          healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar~          degree of insulin resistance.~   "
104572|NCT01688336|"~     This single arm, multi-center phase II clinical trial will assess the safety and efficacy of~     FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA)~     and borderline resectable (BR) pancreatic cancer.~   "
104573|NCT01688323|"~     To look at what types of measures can be used to predict how an older person will tolerate~     chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw~     to look at the different measures.~   "
104574|NCT01688310|"~     This proposed randomized controlled trial will provide important data which will inform and~     enable the Mozambican government and global health programs to more effectively scale-up~     circumcision services. The investigators postulate that voluntary medical male circumcision~     using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method:~     it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and~     is more cost effective than any other currently available technique.~   "
104575|NCT01688297|"~     The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine~     to prevent seasonal influenza. Volunteers will receive placebo as part of the study.~   "
104576|NCT01688284|"~     The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent~     pregnancy losses and the correlation between the numbers of it and embryo toxicity by~     measuring the level of the Th2 cytokines in normal reproductive profile and in patients with~     Recurrent Pregnancy Losses (RPL).~   "
104577|NCT01688271|"~     This study will determine the efficacy of a teaching program incorporating hybrid simulation~     in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral~     nerve block (CPNB).~      This study will also examine the extent of practice change following participation in a~     regional anesthesia teaching program incorporating hybrid simulation. In addition, this~     study will assess remaining obstacles to incorporating the use of US-guided perineural~     catheters through identifying potential future interventions and tool-kits for setting up~     perineural catheter programs.~   "
104578|NCT01688258|"~     (i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum~     (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,~     PCR).~      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and~     2 in patients with genital, anal and oropharyngeal ulcers by a new PCR.~   "
104579|NCT01688245|"~     Investigators aim to test the effectiveness of a text-message-based behaivoral intervention~     in reducing binge drinking among young adults.~   "
104580|NCT01688232|"~     Medical and Scientific Background: Colorectal cancers (CRC) are the leading cancers in both~     genders. This cancer is of prognostic severity. The prognosis of this cancer has not been~     significantly improved. The treatment of colonic cancer is primarily based on surgery.~     Adjuvant chemotherapy is proposed for metastatic cancers (stages III and IV). However nearly~     30% of patients with localized cancer (stage II) will present a recurrence. Despite intense~     research efforts, no markers of sufficient prognostic value (independent of TNM) are~     available to identify this group of patients and justify intensified therapy. The natural~     history of cancer involves interactions between the tumor and the immune system of the host.~     The immune infiltration at the tumor site may be indicative of host response. We showed that~     the density of intratumor memory T cells (CD45RO) and cytotoxic T cells (CD8) in tumor~     regions (the core and the invasive margin) influenced the occurrence of early events of~     metastasis (tumor emboli) and was strongly associated with prognosis of patients with CRC~     (Pagès et al, NEJM-2005). This immune criterion was a better predictor of survival than the~     gold standard histoprognostic data of tumor invasion (T stage and N) and allowed to~     identify a group of patients at high risk of recurrence (*2). The availability of this~     immune criterion in clinical practice could improve the prognostic assessment of patients~     and better guide the therapeutic. A dedicated platform has been implemented in our hospital~     to speed up the transfer of this immune investigation into the clinic. The investigation~     takes into account the density of immune cell populations in tumor regions (the core and the~     invasive front of the tumor). This methodology has been validated for the markers CD45RO,~     CD3 and CD8 and leads to the creation of an immune score (immunoscore ranging from IO to~     I4). We validated the prognostic impact of the immunoscore in a retrospective series of 250~     colorectal cancers. The main objective of this multicentric prospective clinical study is to~     assess in clinical practice the immunoscore and measure its prognostic value. The cohort~     study will include 400 patients with CRC stage I to IV (6 centers for inclusion; Paris-HEGP,~     Dijon, Bobigny-Avicenne, Besancon, Poitiers, Rouen). Two years of inclusion and a follow-up~     of 3 years for each patient will be performed (co-financing for data collection during the~     4th and 5th year planned). For each patient, the pathologist of the center will send to the~     immunomonitoring platform of HEGP tissue sections from a paraffin block containing the tumor~     regions. The investigations will combine a step of immunostaining for CD3, CD8, and CD45RO~     (Ventana automate) markers, high-resolution scanning of the stained slides and~     quantification of digital images by an imaging module developed by our group from the~     program of Developer XD of Définiens company. The immunoscore will be calculated and the~     score will be correlated to the clinical data for the relapse and the survival. The~     secondary objective of this program is to evaluate the prognostic performance of the immune~     infiltrate on the biopsies performed for diagnostic purposes. This study will be conducted~     on patients of the cohort whose biopsies were performed in the same hospital than surgery~     and whose samples are available in pathology laboratories involved (representing 50% of~     cases). For the same patients will be conducted a genetic investigation of the tumor to~     assess the MSI status, the presence of a K-Ras and BRAF mutations. This investigation will~     be performed on tumor sections from the same tumor block selected for the~     immunohistochemical analyses. The sections will be processed by the Department of Biology,~     Hôpital Européen Georges Pompidou. The prognostic performance of the immune investigations~     performed on tumor sections and biopsies will be compared to that of genetic features of the~     tumor. Finally, a questionnaire will be sent every six months along the monitoring of the~     patients to obtain information concerning (i) the emergence of an immune disorder (such as~     allergy, autoimmunity, inflammatory process) and (ii) the psychological status of the~     patients. The potential impact of such parameters during the course of the disease on the~     prediction of the relapse and survival obtained with the immunoscore performed at the time~     of surgery will be evaluated. Expected results : This prospective study is an indispensable~     step for the clinical validation of the prognostic value of the immunoscore. The secondary~     objectives should help to precise the benefit of a concomitant analysis of the biopsy, the~     genetic features of the tumor. The questionnaire should help to identify the clinical~     parameters to track along the monitoring~   "
104581|NCT01688219|"~     The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological~     components. The investigators examined innate and adaptative immune responses in SAPHO~     syndrome as compared with psoriatic arthritis and rheumatoid arthritis.~   "
104582|NCT01688206|"~     This multi-center, open-label study will evaluate the safety, pharmacokinetics,~     pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination~     with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts~     of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD~     and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with~     atezolizumab, intravenously every 2 weeks.~   "
104583|NCT01688193|"~     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the~     HCP1004 and VIMOVO 500/20mg in Healthy Korean Male~   "
104735|NCT01686217|"~     The purpose of this study is to compare the pharmacokinetics (PK) profiles of three~     different strengths of ASP015K extended release formulation and an immediate release~     formulation and to evaluate food effect on extended release strengths in healthy volunteers.~   "
104584|NCT01688180|"~     Patients with chronic diseases are at great risk of depression and anxiety.It is known that~     depression and anxiety are one of the most common comorbidities associated with chronic lung~     diseases such as asthma and chronic obstructive pulmonary disease.~      However,to date,little is known about the rates and risk factors of depression and anxiety~     symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed~     to investigate the effect of depression and anxiety on the healthy outcomes(such as number~     of exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these~     gaps.~   "
104585|NCT01688167|"~     This study proposes to balance supply and demand of male circumcision through a systematic~     scale-up of coordinated biomedical surgical and behavioral counseling services. The study~     will compare the combined biobehavioral sexual risk reduction intervention to the standard~     of care, which focuses exclusively on the provision of circumcision services alone, with the~     goal of optimizing both local and national HIV prevention efforts.~   "
104586|NCT01688154|"~     Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect~     after an acute or chronic consumption in rodents. In this study, we aimed to investigate the~     effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.~     Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape~     seed proanthocyanidins in humans should be elucidated as well as its activity on vascular~     function.~   "
104587|NCT01688141|"~     Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%.~     The study hypothesis is to ascertain if intensive primary care led disease management~     programmes for CKD, supported by input from secondary care specialists will slow progression~     of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD~     registers.~      The investigators have partnered with Nene commissioning, a practice based commissioning~     group representing approximately 80 GP practices in Northamptonshire, to run this study.~     This will be a cluster randomised trial of an intensive, secondary care supported, CKD~     management programme in primary care vs normal CKD care. Randomisation will be at the level~     of the individual general practice. All general practices associated with Nene commissioning~     will be invited to participate. Randomisation of practices will be performed by the~     University of Leicester Clinical Trials Unit and the study will adhere to guidelines for~     undertaking randomised cluster trials.~      The aims of the study are:~        1. To determine whether reinforcement of best practice in the management of key aspects of~          CKD care by clinical nurse specialists based in primary care, but with close links to~          colleagues from secondary care, improves clinical outcomes.~        2. To foster excellence in CKD care~        3. To improve coding of CKD and prevalence on chronic disease registers.~        4. To increase interest in, and capacity for primary care research in Northamptonshire.~        5. To implement and evaluate a new model of partnership working between primary and~          secondary care.~      The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR).~     Secondary outcome measures will be blood pressure control, proteinuria, incidence of~     cardiovascular events,other biochemical parameters, referrals to secondary care and~     hospitalisations and mortality.~   "
104588|NCT01688128|"~     The purpose of this study is to examine the efficacy of the Ubiquitous Spaced~     Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly~     individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover~     Trial.~   "
104589|NCT01688115|"~     The purpose of this study is to evaluate the efficacy of a video shown using an iPad,~     compared to a standard treatment, to reduce preoperative anxiety in children who have to~     undergo to elective surgery procedure~   "
104590|NCT01688102|"~     Participants in this study will be randomized to receive either oral vitamin D pills OR~     ultraviolet light treatment. The investigators will compare how these two methods of raising~     vitamin D levels will affect cholesterol levels.~   "
104591|NCT01688089|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     ODM-103 when given to healthy male volunteers.~   "
104592|NCT01688076|"~     This cross-over design study will evaluate the onset of action, efficacy, and duration of~     botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without~     subsequent muscle contraction.~   "
104593|NCT01688063|"~     The primary objective of Part A is to compare the change in elasticity measurements at~     baseline and at 3 months between subjects who have had a resurfacing or tightening procedure~     and those who have not. The secondary objective for Part A is to develop baseline elasticity~     scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and~     V-VI. The primary objective of Part B is to compare the age of the scar and surrounding~     tissue with the elasticity measurements.~   "
104594|NCT01688050|"~     The TRANSFIX study is a clinical trial approved by US FDA to study the safety and~     effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt~     Thoracic Aortic Injury.~   "
104595|NCT01688037|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses~     (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia~     (TD) symptoms.~   "
104596|NCT01688024|"~     The purpose of this study is to determine the effectiveness and safety of mitomycin C in the~     treatment of primary sclerosing cholangitis (PSC).~   "
104597|NCT01688011|"~     The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into~     treatment regimens and sequencing of these regimens as they relate to clinical outcomes of~     patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate~     molecular and cellular markers that may provide further prognostic classification and/or~     might be predictive of therapy outcomes.~   "
104598|NCT01687998|"~     The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in~     participants with high-risk vascular disease (HRVD).~   "
104599|NCT01687985|"~     A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated~     adults.~   "
104600|NCT01687972|"~     The proposed study is a randomized controlled trial with two arms. All patients admitted to~     Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered~     entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,~     the patient will be randomized at time of cesarean section to receive skin closure by either~     the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the~     standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment~     score (PSAS) will be obtained during this visit. The patient will then be contacted by~     telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)~     assessing her satisfaction with the resulting scar.~   "
104736|NCT01686204|"~     The main objective of this work is to conduct a clinical trial in obese and non-obese~     individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health~     and reduce chronic inflammation. Our central hypothesis is that short and long-term~     consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese~     individuals by improving intestinal barrier function.~   "
104601|NCT01687959|"~     Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography~     for acute biliary pancreatitis is a controversial issue. There are still many confounding~     findings offering either early laparoscopic cholecystectomy within 72 hours following~     endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is~     known to be an important factor in peritoneal healing and adhesion formation. Measurement of~     tissue concentrations of tissue-type plasminogen activator and its specific activity,~     urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought~     to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.~   "
104602|NCT01687946|"~     RESOLVE's objective is to identify and characterize validated molecular targets capable of~     shifting primary organ repair towards fibroproliferative wound healing.~      Work package 2 (WP2) of RESOLVE includes the clinical study protocols within the RESOLVE~     system evaluating different forms of pulmonary repair in humans ranging from normal repair~     over mainly inflammatory to predominantly fibroproliferative repair.~      Hypothesis~      Fibrosis of the lung is an aberrant and intensified form of wound healing. It is the result~     of an unresolved disturbance of both initiation and control of repair which is partly~     age-related. As a result of the relentlessly activated wound healing reaction, mechanisms of~     inflammation largely representing the condition of chronic inflammation within the~     peripheral bronchial tree will aggravate this abnormal form of repair.~      A systematic comparison of the molecular pathology of fibrotic repair representing~        -  Varying intensity of fibrosis related to the pathology of usual interstitial pneumonia~          (UIP),~        -  Varying inflammatory mechanisms (UIP vs. Hypersensitivity pneumonitis [HP], acute and~          chronic), and~        -  Varying stages of age (Normal pulmonary repair in young and old individuals vs.~          acute/chronic HP vs. UIP) will be able to~        -  identify molecules capable of shifting regular repair towards fibroproliferative repair~          and~        -  elucidate their interrelationship with other molecules forming coordinated yet~          misdirected metabolic responses characteristic for fibroproliferative repair.~   "
104603|NCT01687933|"~     There are different medicinal and non medicinal methods to control labor pain. Today, much~     attention has been on non medicinal methods because of limitations and complications of~     medical procedures. Virtual reality is a new and promising method of diversion of mind that~     may have an impact on labor pain. This study was conducted to determine the effect of~     virtual reality on the first stage of labor pain.~   "
104604|NCT01687920|"~     This study should estimate the dose proportionality of BAY94-8862 IR tablets.~   "
104605|NCT01687907|"~     The aim of this trial is to find out if active music listening during pregnancy and delivery~     reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if~     there is an effect on delivery complications. Also we try to find out if there is any~     influence on mother-baby relationship.~   "
104606|NCT01687894|"~     Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral~     ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral~     oxygenation are evaluated during surgery in BCP.~   "
104607|NCT01687881|"~     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for~     cervicogenic headache (CEH). If the method proves to be effective, it will provide a new~     non-pharmacological treatment option for CEH. This is especially important since~     pharmacological management has minor effect in CEH, and alternative treatment options are~     warranted. The applied methodology of the study will aim towards the highest possible~     research standards. This international study is a collaboration between Akershus University~     Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University,~     Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic~     and medicine. By increasing the methodological quality of the investigators research to a~     very high level, the investigators see the method to work as a guide to increase the quality~     of chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH~     used methodology showing room for improvement.~      Study hypothesis:~      CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo~     (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low~     amplitude) and no intervention (control group).~   "
104608|NCT01687868|"~     Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for~     adverse neurologic events due to cerebral ischemia.~      Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial~     blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the~     perioperative period.~      dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically~     appropriate for reducing bleeding for arthroscopic operation field.~      The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on~     cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in~     patients undergoing arthroscopic shoulder surgery in the beach-chair position.~   "
104609|NCT01687855|"~     The aim of this study was to evaluate the dynamic changes of the tongue in patients with~     obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using~     Ultrafast Magnetic Resonance Imaging (UMRI)~   "
104618|NCT01687738|"~     Purpose: Overall lung surgery rates and black/white disparities have not improved during a~     decade of documentation. The goal of this study is to incorporate lessons from the previous~     prospective cohort study to optimize lung cancer surgery rates and narrow black-white~     disparities for patients diagnosed with stage I or II, non-small cell lung cancer.~      Participants: Stage I and II, non-small cell lung cancer at 3 participating sites.~     Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year,~     retrospective chart review, used to establish the baseline surgical rates for the~     intervention. The patient enrollment phase of the study will move forward that will include~     use of a real time registry to follow patient progression through clinical follow up,~     diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small~     cell lung cancer. The patient enrollment portion of the study will start, September 2012.~     All patients with Stage I or II non-small cell lung cancer who enroll in the study will be~     entered into real time registries at every site. Patients' progress through the registries~     including follow-up provider visits, diagnostic tests, and procedures will be transparent~     and any missed appointments will be flagged. Feedback will be given to lung cancer providers~     in both arms. The randomized trial will compare patients who receive usual care plus the~     registry to those who receive the registry plus visits and calls from a trained cancer~     communicator -educator (CCE) who is well versed in issues specific to lung cancer and~     trained in active listening and communication that accounts for patients' limitations in~     health literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or~     beliefs that represent barriers to recommended care that could potentially be addressed~     through negotiation and more targeted communication.~      The hypothesis is that an electronic warning system, data transparency, and enhanced~     communication will optimize lung surgery rates and reduce racial gaps.~   "
104610|NCT01687842|"~     Monocentric multidisciplinary study (psychologists, endocrinologists, psychiatrists, and~     molecular biologists) to characterize social cognition in adolescents with Turner syndrome~     (TS).~      Inclusion criteria:~        -  Turner syndrome with homogeneous 45,X karyotype.~        -  Age between 8 and 18 years.~        -  Somatic state compatible with the evaluation.~        -  Functional language and IQ ≥ 80 for the transfer tests~        -  Informed consent signed by the holders of parental authority, the patient and the~          mother for her own participation (DNA collection).~        -  Affiliation to Social Security (beneficiary or assignee).~      The primary endpoint will be the overall score to the AQ (Autism Quotient) questionnaire and~     to the SRS (Social Reciprocity Scale), in comparison to the expected scores for the general~     population. For patients with scores above the threshold for SRS or QA validation of a~     possible diagnosis of autism spectrum disorders will be performed with commonly used~     diagnostic tools (ADIR (Lord et al, 1994), ADOS-G (Lord et al, 1999) and diagnostic criteria~     of DSM IV-TR).~      Secondary criteria will include the results of standardized tests to assess autistic~     features (AQ, ADI-R, ADOS, DSM IV-TR criteria), intellectual efficiency (Wechsler scales),~     psychiatric comorbidities (Kiddie-SADS) and sociocognitive profile (SpeX test, Social~     cognition, Perception, eXecutive functions).~      A DNA sample will be collected from the patient and her mother. The observation period is 2~     days for the patient and about 1 hour for the mother. The total duration of the study is 3~     years.~   "
104611|NCT01687829|"~     Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by~     vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and~     visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has~     become used widely as an adjunctive procedure during MH surgery because the removal of ILM~     is thought to reduce the tangential traction on the macula, a major factor in the~     pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole~     surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on~     comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the~     published literature comparing surgical results with and without ILM peeling and and~     performed a meta-analysis to determine whether there is any benefit or detriment~     anatomically and/or visually.~   "
104612|NCT01687816|"~     This is a prospective specimen collection study targeting patients presenting with Influenza~     Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A~     non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be~     used. These nasal swabs will be collected in different volumes of viral transport media~     (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected~     biological specimen. The collection of nasal swabs samples will support the optimization of~     point of care detection methods for respiratory viruses responsible for ILI and/or ARI.~   "
104613|NCT01687803|"~     The overall goal of this study is to determine the health benefits associated with the 2005~     Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The~     2005 Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults~     should participate in 60 minutes of moderate to vigorous intensity physical activity on most~     days of the week.~   "
104614|NCT01687790|"~     The primary hypothesis of this project is that using molecular breast imaging (MBI) in~     evaluating women with equivocal mammographic or sonographic findings will demonstrate high~     specificity in distinguishing benign from malignant breast disease and, as a result,~     decrease the number of biopsies.~   "
104615|NCT01687777|"~     Surgical reconstructive procedures for rotator cuff tears present a number of limitations.~     The few studies in which the repair integrity is evaluated, have shown the existence of a~     high rate of reruptures in spite of the fact that the functional results obtained short-term~     are satisfactory. Morphologic analysis from the sutures, after different follow-up periods,~     has not shown satisfactory results.~      Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem~     cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the~     function compared to cell-free tendon defect treatment.~   "
104616|NCT01687764|"~     The objective of this project is to test the combination of active or placebo Attentional~     Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or~     Psychoeducational Control Intervention (PCI) for anxiety disorders in children.~   "
104617|NCT01687751|"~     Cancer patients with very difficult to control symptoms at the Abbotsford (AC) and Fraser~     Valley (FVC) Cancer Centers are referred and admitted to the Tertiary Palliative Care Units~     at the Abbotsford Regional Hospital and Cancer Center(ARHCC). For symptom management,~     patients are sometimes given midazolam continuously through a needle placed underneath the~     skin. While effective in symptom management, midazolam can be sedating, leaving patients~     unable to interact with loved ones in their last days.~      This study is a pilot project. Before proceeding to a full-scale study, a pilot study or~     feasibility study is often carried out first to test the design of a study, the likelihood~     of successful recruitment or the acceptability of the intervention to potential subjects.~     The basic idea is to find out whether it will be practical to proceed to a larger study that~     will include more subjects. This type of study involves only a small number of subjects and~     therefore the results can only be used as a guide for further larger studies.~      The investigators also will determine whether palliative care cancer patients taking a~     medication called dexmedetomidine would have improved rousability (more easily and fully~     awakened) and symptom control (pain, shortness of breath, nausea or confusion) compared with~     those taking standard of care which is receiving the medication midazolam. The use of~     dexmedetomidine in other clinical situations (in the Operating Room or Intensive Care Unit~     where the patient can still respond to the doctor) has been shown to be effective in symptom~     control and to provide a better degree of rousability to patients but has not been well~     studied in the palliative care environment.~   "
104644|NCT01687400|"~     This clinical trial studies potential genetic markers which might be used to predict which~     patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine.~     This study will contribute to the efforts to find effective and less toxic therapies to~     provide durable remissions in a significant proportion of elderly AML patients.~   "
104645|NCT01687387|"~     Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of~     lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients~     with Acute Myeloid Leukemia (AML) in first complete remission~   "
104619|NCT01687725|"~     In patients with treatment resistant hypertension renal nerve ablation emerged as an~     effective interventional approach of treating hypertensive disease with a progressively~     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is~     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the~     precise mechanisms that causes the fall in blood pressure in the short-term and, in~     particular, long-term remains elusive. The objective of the study is to understand the~     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic~     nervous system. In 100 hypertensive patients most advanced technology will be applied,~     before and repeatedly after renal denervation, throughout the follow-up period of 1 year.~     Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin~     labeling technique), local activity of the renin angiotensin system in the kidney (urinary~     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI~     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large~     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over~     24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the~     fall in blood pressure after renal denervation may help to identify those hypertensive~     patients that profit most from renal nerve ablation in terms of blood pressure reduction.~      The investigators propose the following hypotheses why a progressive decrease in blood~     pressure happens, in addition to the decreased activity of the central nervous system, after~     renal nerve ablation:~      Short term effects:~      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the~     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation~      Long term effects:~      D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall~     properties after 6 and 12 months~   "
104620|NCT01687712|"~     The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle~     stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to the~     widely used and marketed r-hFSH Gonal-f.~   "
104621|NCT01687699|"~     Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we~     demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis~     (HD) patients. In the present study, we assess whether low-dose spironolactone treatment~     reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in~     HD patients. The investigators' hypothesis is that aldosterone receptor blockade by~     spironolactone reduces the risk of both CCV morbidity and death among HD patients.~   "
104622|NCT01687686|"~     The role of lipids as risk factors for cardiovascular events is well-documented, although~     events studied have largely been broad classes without specific detail. This study will~     examine a more refined set of endpoints.~   "
104623|NCT01687673|"~     This Phase II trial is being developed following the completion of a Phase I study of the~     combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced~     hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose~     (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV~     weekly plus sorafenib 200 mg (oral, twice daily).~   "
104624|NCT01687660|"~     Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A~     open-label randomized controlled trial. 249 participants will be included. Three arms:~     acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.~   "
104625|NCT01687647|"~     Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this~     population relies on repeated CT-scans which are more accurate for detection of peripheral~     lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using~     automate cytometry may be of interest in this population, alone or in combination with~     CT-scan.~      An ancillary study will evaluate the interest of blood predictive biomarkers.~   "
104626|NCT01687634|"~     In the Pico-Union/Koreatown community of Los Angeles investigators are designing a~     preventive health care model that increases the opportunities for families to make healthy~     choices -- in their homes, schools & communities. The project's key element is: Lay~     community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make~     home visits to pregnant mothers & newly-delivered mothers who have agreed to participate in~     the research study.~      Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months~     post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use~     during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare~     adherence.~      Investigators will implement the study with 6 MMs, who will maintain an average caseload of~     16 women each across an 18-month period. Each participant will be visited (or receive the~     intervention by telephone) twice per month.~      Separate Assessment Team members will conduct assessments at: Baseline, within a week of~     birth of the target child, and 6 months from birth.~   "
104627|NCT01687621|"~     The objective of this study is to develop and test a simple community-based diagnostic~     algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated~     community-based algorithms developed and tested in the sub-Saharan context where the~     manifestations of omphalitis presentation may vary and diagnosis could be potentially more~     challenging in infants with darker skin color. Given the current attention to cord care at~     the global and national policy level, validated community-based algorithms will be needed to~     allow primary health workers to identify cord infections and reduce associated morbidity.~      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health~     facility for routine or sick visits will undergo two independent, parallel evaluations;~     first, by a community level worker and second, by a Zambian medical doctor (gold standard).~     A third independent assessment of a photo of the cord will be performed remotely by a~     board-certified pediatrician. Using the on-site clinician as the gold standard, the~     community-based algorithm and the photo assessment will be tested for concordance and the~     sensitivity and specificity of the algorithm will be generated. Likewise, the remote~     pictorial assessment will be compared to the gold standard to determine reliability of~     diagnosis from photographs alone.~   "
104628|NCT01687608|"~     The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor~     IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.~   "
104629|NCT01687595|"~     The purpose of this study is to evaluate the effect the HerpV vaccine has on recurring~     episodes of genital herpes by evaluating viral shedding before, after treatment.~   "
104630|NCT01687582|"~     The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog~     treatment on psoriatic skin lesions in patients with type 2 diabetes.~   "
104631|NCT01687569|"~     The purpose of this study is to determine whether added ingredient affects glycaemic~     responses to a cracker snack.~   "
104632|NCT01687556|"~     Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris~        -  major polyphenolic constituent in green tea~        -  known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and~          antimicrobial activities~        -  lipid-lowering and antiandrogenic properties was reported~        -  EGCG can improve acne vulgaris via one of the above mentioned actions.~   "
104633|NCT01687543|"~     Symptoms of Clostridium difficile infection is almost always induced as a complication to~     the use of antibiotics. Most ICU patients are given antibiotics.~      Probiotics has the ability to improve conditions in the gut and it has been shown in some~     smaller studies that overgrowth of C. difficile can be reduced or prevented.~      In this study the intention is to show with sufficient statistical power that a mixture of~     two otherwise well studied probiotic strains reduces or prevents the incidence of emerging~     colonisation with C. difficile in critical ill patients on antibiotics.~      Half of the patients will be given a mixture of Lactobacillus plantarum 299 and~     Lactobacillus plantarum 299v twice daily and the rest a placebo mixture.~      Rectal swabs or faeces will be analysed for C.difficile and its toxins and the incidence of~     new cases will be compared for the two groups.~      White blood cells (WBC´s), C reactive protein (CRP), lactate, urea, and creatinine will be~     followed daily as well as antibiotics, corticosteroids and all acid reducing medication.~      Nutrition, enteral and total, and bowel habits will be recorded.~   "
104634|NCT01687530|"~     Certain types of fractures require surgical intervention that may involve the use of bone~     grafts or bone graft substitutes. Many of the materials used as bone graft substitutes~     suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate~     blood supply, failure to encourage the production of bone and ectopic bone formation.~      A guided bone regeneration (GBR) environment may help in solving these clinical concerns.~     GBR has been widely used in the field of dentistry since the 1980s to provide stable~     placement for dental implants~      The purpose of this study is to evaluate the safety, performance and initial efficacy of~     Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma~     applications.~   "
104635|NCT01687517|"~     Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs,~     especially the lungs and mediastinum. Some location of sarcoidosis may require treatment~     with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be~     recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary~     fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators~     presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal~     influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal~     influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis~     patients than in the general population. Similarly, it is unclear whether the vaccine~     response is modified by the severity of the disease and treatment with corticosteroids and~     immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which~     are both inflammatory and autoimmune diseases, the investigators expect at best a 50%~     vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy~     controls. The demonstration of a vaccine response could allow reconsidering new vaccine~     approaches in sarcoidosis.~   "
104636|NCT01687504|"~     Tuberculosis (also known as TB) is a common infection and a major cause of death in~     children. Effective treatment using a combination of anti-tuberculosis (anti-TB) medications~     saves lives, but dosages of these medications are not well established in children. Several~     research studies have shown that the recommended dosages of the anti-TB medications in~     children do not lead to adequate blood levels to kill the bacteria in some children. This~     situation may lead to treatment failure and emergence of drug resistance. As a result, the~     world Health Organization (WHO) recently recommended increased dosages for all the TB~     medications in children. This study is being conducted to find out if the increased dosages~     of the anti-TB drugs are safe and lead to adequate drug levels in the blood of children with~     TB with or without HIV infection.~   "
104637|NCT01687491|"~     This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®,~     conducted on two parallel groups of patients admitted in emergency for acute coronary~     syndrome.~   "
104638|NCT01687478|"~     The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine~     compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in~     Chinese participants.~   "
104639|NCT01687465|"~     Lasers are important therapy in glaucoma. They are a pivotal point in treatment between~     medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser~     treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used:~     argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT~     including causing less damage to the tissue it affects. One of the potential patient~     centered benefits of this laser is that it may be repeatable. It is even possible that the~     old laser ALT may be useable after an SLT treatment. This study aims to uncover whether~     repeat laser is possible after SLT and if so which laser is more effective (ALT vs SLT). The~     potential of repeating laser therapies may delay surgical treatment and its complications.~     Also understanding which laser to use will help eye doctors know how to treat their patients~     at this point of the disease.~   "
104640|NCT01687452|"~     The aim of the investigators study is to demonstrate in healthy subjects and a cohort of~     patients infected with HIV, the presence of miRNAs in circulating peripheral blood~     microparticles (MPs).~   "
104641|NCT01687439|"~     Primary objective: functional imaging and quantitative imaging detection of the effects of~     Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).~      Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and~     normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.~   "
104642|NCT01687426|"~     The purpose of this study is to determine the intraocular Pressure (IOP) lowering response~     and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects~     with open angle glaucoma or ocular hypertension.~   "
104643|NCT01687413|"~     This clinical trial studies the intensity of adjuvant (helper) therapy required in p16~     positive oropharynx cancer patients, who have had all known disease removed surgically by a~     minimally invasive approach, and who have extracapsular spread in their lymph nodes.~     Patients can consent to participate in either the randomized (physician chooses radiotherapy~     arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or~     radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone,~     or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,~     functional and quality of life outcomes.~   "
104646|NCT01687374|"~     Hypothesis:~      The investigators want to study whether parathyroid hormone improves healing of humerus~     after a fracture. The investigators will assess healing of the humerus with Constant score.~   "
104647|NCT01687361|"~     Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in~     order to increase or restore muscle capacities of hypoactive patients or patients with~     articular trauma. Although this technique seems to be particularly adapted to muscle~     rehabilitation, growing evidence is emerging regarding potential damaging effects of~     electrically- induced isometric contractions in healthy humans. Recent studies have reported~     a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased~     muscle soreness and impaired force production as a result of NMESs. On that basis, further~     studies should be conducted on these deleterious effects which might limit the clinical~     application of NMES.~      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)~     supplementation as a potential prophylactic/therapeutic approach. The rationale of this~     approach is that BCAA might increase protein synthesis and reduce protein breakdown through~     physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).~     Additionally, BCAA could also be used as energetic substrate during exercise when glycogen~     stores are depleted. Overall, previous results have supported the efficacy of BCAA~     supplementation in attenuating muscle damage. Nevertheless, comprehensive studies~     investigating the effect of amino acid supplementation on markers of muscle damage are still~     scarce.~      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)~     are powerful non invasive tools allowing the exploration of skeletal muscle structure and~     energy metabolism.~      This ambitious project is devoted to the anatomical, functional and metabolic~     characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers~     of muscle damage, including maximal voluntary force production, T2 values and apparent~     diffusion coefficient (obtained by MRI) and energy metabolism assessed at rest and during~     exercise (using 31P-MRS), will be obtained before and after NMES. This project is of utmost~     importance for improving our knowledge of anatomic, metabolic and functional events related~     to BCAA supplementation in the context of exercise-induced muscle damage~   "
104648|NCT01687348|"~     Prospective, monocentric, open-label study conducted in women requiring mastectomy and~     eligible for tumescent infiltrative anaesthesia.~      Blood samples will be collected during 48h after start of infiltration. Total and free~     lidocaine concentrations measurements will be determined by gas chromatography. Visual~     analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs~     and adverse effects will be collected.~      Population pharmacokinetic parameters will be estimated using NONMEM software and covariates~     influence on parameters variability will be tested.~      Primary outcome value: Population pharmacokinetic parameters with possible covariates~     influence on variability.~      Patients and period of study: n=30 patients enrolled during 24 months, total study duration:~     30 months.~   "
104649|NCT01687335|"~     The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is~     variable in function: the location and the extension of the tumor, of the general state , of~     age, of the socio-economic class and the pain. The health consequences of a malnutrition are~     very important: aggravation of the state of health, complications of treatment,~     hospitalization, alteration of the quality of life and decrease the survival, and the~     treatment response.~      Nutrition being very important in patients, there are recommendations for the nutritional~     care of these patients, formulated by the European Society for Clinical Nutrition and~     Metabolism. The investigators do not know to what extent these recommendations are respected~     in practice and their influence on the nutritional status and the quality of life of~     patients.~      The investigators therefore propose to assess the conformity of the nutritional care~     patients in clinical practice in relation to the European recommendations and in a second~     time to assess the influence of this compliance or non-compliance on the nutritional status~     clinical and biological of cancerous patients under chemotherapy, on their quality of life,~     on their response to treatment and on their survival.~      The investigators will try to identify factors that may be linked to the non-compliance such~     as the characteristics of the cancer disease, socio-demographic characteristics of the~     subject and the factors related to the structure in which it is supported.~   "
104650|NCT01687322|"~     The investigators want to contact patients that underwent total hip replacement for the past~     ten years. The investigators will ask them about their daily living, functioning and quality~     of life.~   "
104651|NCT01687309|"~     A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     single and repeat doses of 800 mg GSK2586184 in healthy subjects.~   "
104652|NCT01687296|"~     This is a multicentre, randomized, double-blind, double-dummy, active-controlled,~     parallel-group study to determine the efficacy and safety of nebulized fluticasone~     propionate 1mg twice daily compared with oral prednisone administered for 7 days to Chinese~     pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma~   "
104653|NCT01687283|"~     This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III~     local registration study for a treatment period of 12 weeks. This study aims to assess the~     effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of~     Chinese adult and adolescent patients with severe persistent asthma for a treatment period~     of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma~     pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.~   "
104654|NCT01687270|"~     This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in~     adults who have had a liver transplant which has become re-infected with hepatitis C. The~     treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study~     will last up to 72 weeks not including the screening visit.~   "
104655|NCT01687257|"~     This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF)~     plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic~     hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to~     receive study drug for 48 weeks or take part in an untreated observational arm for the first~     24 weeks followed by study drug for another 48 weeks.~   "
104656|NCT01687244|"~     This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN~     with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder~     cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of~     INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the~     urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the~     interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the~     ability of the adenoviral vector to transfect cells in the bladder wall.~   "
104687|NCT01686841|"~     To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ~     System.~   "
104688|NCT01686828|"~     The purpose of this research study is to understand the effects of testosterone and estrogen~     on the body's response to the hormone insulin.~   "
107402|NCT01651052|"~     The purpose of this observational trial is to gather further clinical data to confirm the~     safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this~     trial population.~   "
104657|NCT01687231|"~     In the transplant community, there is debate regarding the most appropriate food services~     for stem cell transplant patients. Recommendations regarding the use of low bacterial diets~     have been based on theoretical concepts of reducing the risk of contracting infections from~     pathogens found in food sources rather than clinical trials. The evidence for the use of a~     neutropenic diet is weak. To date, there have been little to no randomized controlled~     studies addressing the question whether a neutropenic diet in addition to prophylactic~     antibiotics is necessary as infection prevention in myeloablative stem cell transplant~     patients. For this reason, our research is aimed at providing data to substantiate the use~     of neutropenic diets in preventing infections in recipients of myeloablative stem cell~     transplants.~   "
104658|NCT01687218|"~     MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label~     crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir~     gel. The study population will be sexually active, HIV-uninfected males who are 18 years of~     age or older, who report a history of receptive anal intercourse in the past 3 months. Each~     of the study product regimens offers different advantages to participants seeking an~     effective HIV prevention agent. How these relative advantages will compare in terms of~     safety, acceptability, systemic and local absorption, and adherence will be examined within~     this study.~   "
104659|NCT01687205|"~     Study Objectives:~        -  To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel~          in female genital tract secretions, vaginal and cervical tissue and rectal tract~          secretions~        -  To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by~          measuring the anti-HIV-1 activity in CVL samples~      Study Summary:~      MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners~     are healthy and HIV-negative. The female participants must be between the ages of 21-46~     (inclusive) and currently using effective non-barrier contraception. Male participants must~     be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in~     the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and~     extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus.~     Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the~     timing in which coitus might have the greatest impact on these variables, which is when gel~     is applied shortly prior to coitus in the absence of a drug reservoir.~      MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly~     before sex and compare to PK/PD assessments following a single gel application without sex.~     Additionally, data obtained from a visit in which participants do not dose with gel and do~     not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the~     antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then~     the anti-HIV activity in CVL collected at the visit in which female participants dose with~     gel and have sex should be comparable to that of CVL collected at the visit in which females~     dose with gel and then do not engage in intercourse and significantly greater than the~     endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose~     with gel but do have sex and the visit in which no gel is administered and sex does occur.~     Data analysis performed after the completion of enrollment and follow-up procedures will~     demonstrate if there is an impact of coitus and semen on PK/PD when a single 1% tenofovir~     dose is applied shortly prior to sex.~   "
104660|NCT01687192|"~     PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic~     response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis~     is that the immunologic response to tetravalent vaccine in girls who received~     immunosuppressive treatment is comparable to the immunologic response in girls that are not~     immunosuppressed.~   "
104661|NCT01687179|"~     Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the~     combination of sirolimus and hydroxychloroquine is safe and well tolerated~      Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy~     with sirolimus and hydroxychloroquine results in improvement of indicators of disease, and~     whether the gains are sustained after stopping therapy.~      Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood~     signature to predict rates of disease progression and determine responsiveness to~     combination therapy.~      This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted~     to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken~     orally daily. Up to 18 adult women with LAM will be enrolled.~   "
104662|NCT01687166|"~     The purpose of this study is to establish the safety and effectiveness of the Blazer~     Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory,~     recurrent, symptomatic, paroxysmal atrial fibrillation.~   "
104663|NCT01687153|"~     Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat~     related problems and may be associated with a greater risk of Alzheimer's disease (AD). The~     purpose of this study is to examine the possible connections between TBI and PTSD, and the~     signs and symptoms of AD on Veterans as they age.~      The information collected will help to learn more about how these injuries may affect~     Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in~     Iraq and Afghanistan, who also have these types of combat related injuries.~   "
104664|NCT01687140|"~     Pediatric obsessive compulsive disorder (OCD) is a relatively common and often severe~     condition that can become chronic if untreated. One of the most effective treatments for OCD~     is a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP~     involves presenting a patient with feared objects or situations (the content of their~     obsessional fears) in a gradual manner while helping them use coping techniques to refrain~     from engaging in rituals (compulsions). Despite several studies suggesting that ERP is an~     effective treatment for pediatric OCD, many youngsters fail to respond to this treatment, or~     respond only partially.~      An exciting recent finding from animal research is the ability of an established antibiotic~     (traditionally used to treat Tuberculosis), D-cycloserine (trade name: Seromycin) to enhance~     certain types of learning among rats. The type of learning that is enhanced is called~     extinction learning and many researchers believe that extinction learning is the equivalent~     process to what occurs during ERP; it is the process whereby repeated exposure to the object~     of fear without any bad outcome causes the object to cease being associated with danger.~     Several clinical trials using ERP and other forms of exposure treatment for adults with~     anxiety disorders reproduced this finding from the animal literature; pairing DCS with~     exposure treatment (comparable to extinction learning) resulted in greater fear reduction~     than when no DCS was administered. The effects of DCS on exposure treatment for anxiety~     disorders among children has been tested only preliminarily in one study of children with~     OCD and results were unclear with children who received DCS augmentation showing~     non-significant but increased levels of improvement as compared with children who did not~     receive DCS augmentation.~      In this study, 26 youngsters ages 7-17 with a primary diagnosis of OCD will be recruited and~     assigned at random to one of the two treatment conditions. Youth in the DCS condition of the~     study will receive 50 mg DCS 1 hr prior to each treatment session, while youth in the~     placebo condition receive an identical placebo capsule 1 hr prior to each treatment~     augmentation session. All participants will receive 180 minutes of CBT for OCD 4 days per~     week for 2 weeks during their study participation (as included in IOP already). All families~     complete a thorough evaluation no more than 5 days prior to receiving DCS on their 9th~     treatment visit in IOP (third week), and at mid-treatment augmentation (after the 12th IOP~     treatment session), post-treatment augmentation (after the 16th IOP treatment session), and~     3-month follow-up (12 weeks after the 16th IOP treatment session). The primary aim of this~     study is to obtain preliminary data comparing the effects of the acute administration of DCS~     versus placebo on symptom response to exposure treatment for pediatric OCD. Results from~     this study will help to inform and refine future studies, and eventually, impact treatments~     for pediatric OCD.~   "
104689|NCT01686815|"~     This study aims to utilize state of the art procedures such as the frequently sampled~     intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein~     analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the~     metabolic abnormalities associated with other atypical antipsychotic treatments, namely~     olanzapine and risperidone, and offers an advantage over these other agents.~   "
104665|NCT01687127|"~     Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin~     folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The~     underlying biochemical mechanisms for how folic acid affects health outcomes however are~     unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and~     discussed as an adequate substitute to folic acid. This study aims to determine the effect~     of folic acid compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols~     will be used that allow determining the effect of folic acid on the dynamics of metabolic~     pathways in the human body.~      Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate~     dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key~     enzyme of the folate metabolism will aggravate the effect of folic acid on the metabolic~     pathways.~   "
104666|NCT01687114|"~     This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful~     marker of cranberry intake. We hypothesize the consumption of this cranberry beverage in a~     progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,~     nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,~     endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index~     (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women~     in this age range are particularly vulnerable to urinary tract infection. Volunteers will be~     asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a~     weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot~     urine samples each will be collected from subjects during the study. Urinary PAC-A2~     concentration will then be determined to validate if it can serve as a marker of compliance~     of cranberry juice consumption.~   "
104667|NCT01687101|"~     This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with~     or without aura. STOPAIN is an over-the-counter product that is used for the temporary~     relief of minor aches and pains of muscles and joints associated with simple backache,~     arthritis, strains, bruises and sprains. We plan to have subjects apply the product during a~     single migraine attack to see if it will alleviate the headache pain and associated~     symptoms.~   "
104668|NCT01687088|"~     Olfactory impairment is a common symptom of neurologic disorders and may be related to~     dopaminergic dysfunction. Studies show that patients with migraine show increased~     sensitivity to light and sound. In our previous study in episodic migraineurs, olfaction was~     similar to age and sex-matched controls outside of attacks, but lower during acute attacks.~      The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment~     of olfaction at baseline but a more significant impairment during migraine or headache~     exacerbations.~      The investigators have two objectives:~        -  To determine baseline olfactory acuity in subjects with CM and compare them to age and~          sex-matched controls~        -  To determine how olfaction changes during acute exacerbations of migraine in those with~          CM~      To execute this study, the investigators will interview subjects and controls to ensure that~     they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and~     controls will complete a questionnaire survey regarding their history or lack of history of~     headaches, smell sensitivity, osmophobia and current medication use and answer questions~     about attack frequency, location of headache, duration of disease, use of medication for~     pain, and disability. Both migraineurs and controls will take the University of Pennsylvania~     Smell Identification Test (UPSIT) in the office.~      After the first visit, migraineurs and controls will self-administer the UPSIT at home. They~     will be required to return the second test to the Jefferson Headache Center.~      The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT~     scores between subjects and controls. To achieve a 90% power that the study will detect a~     statistically significant difference between the mean UPSIT scores at a two-sided 5 percent~     significance level, our sample size for both subjects and controls is 50.~   "
104669|NCT01687075|"~     The purpose of the study is to evaluate clinical performances of Cre8 in all comer~     population in Subjects over 18 years old who are undergoing a clinically indicated coronary~     angiogram and angioplasty on de-novo lesion located in native coronary arteries~   "
104670|NCT01687062|"~     Anemia is one of the most common health problems all over the world with around half of~     preschool-aged children (<5 years) and one third of women affected. Nutritional iron~     deficiency is a major reason for anemia in infants, young children and women of reproductive~     age who have especially high iron requirements that are difficult to meet in regions where~     the major diet is based on plant foods. So in Ethiopia, where injera is the major staple~     food. Despite high levels of iron in tef, the most favored cereal for injera, the iron~     bioavailability is assumed to be very low due to the high levels of phytic acid found in~     tef.~      The aim of this study is to determine the iron bioavailability in women from injera prepared~     in a traditional way and investigate the potential of methods to improve the bioavaiability.~     Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be~     evaluated. Further the potential positive impact of phytic acid reduction on the iron~     bioavailability will be investigated. The phytic acid reduction will be achieved in two~     different ways, by addition of whole grain wheat as source of phytase and addition of a~     commercially available microbial phytase. The studies will be conducted in healthy women~     using stable isotope techniques.~   "
104671|NCT01687049|"~     Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon~     cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing~     statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown~     that RYR has direct effects on androgen dependent and androgen independent prostate cancer~     cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those~     subjects with localized prostate cancer who have chosen to be managed by active~     surveillance.~   "
104672|NCT01687036|"~     Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System~     consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole~     Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events~     (AEs).~   "
104673|NCT01687023|"~     The goal of this research study is to show that features derived from data gathered using~     SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of~     exercises that are part of Tai Chi interventions.~   "
104674|NCT01687010|"~     Sepsis is a common cause for morbidity and mortality in critically ill patients. With the~     development of medical skills, the mortality is still remain very high. Inappropriateness of~     initial antibiotic treatment is an important risk factor for mortality and effective~     antimicrobial administration within the first hour of documented hypotension was associated~     with increased survival to hospital discharge in adult patients with septic shock. However,~     the early treatment based on early diagnosis.But it is very difficult to diagnosis because~     of lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be~     helpful to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited.~     Therefore, combine several biomarkers could enhance the diagnostic value.~   "
104675|NCT01686997|"~     Morbid obesity is an increasing medical problem in the western countries. It's related to~     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.~     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese~     patients. A part of these patients will have disappointing results, and have weight regain~     on the long term. Some studies show more weight reduction by increasing the biliopancreatic~     limb in patients with morbid obesity.~      The objective of this study is to investigate the effect of variations in the length of~     biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.~     We hypothesize that longer biliopancreatic limb results in more weight reduction.~      The study design is a prospective, randomized control trial. The patients will be randomized~     in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb~     RYGB.~   "
104676|NCT01686984|"~     The purpose of this study is to investigate how inspiratory flow pattern influences CO2~     elimination in people without primary lung disease.~      The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause~     and high end-inspiratory flow, will promote CO2 exchange in the alveoli.~   "
104677|NCT01686971|"~     A questionaire for cancer patients without an active treatment in order to evaluate their~     needs and/or demands.~   "
104678|NCT01686958|"~     This study is to evaluate that the MRI-guided transurethral ultrasound therapy system is~     safe and feasible to ablate prostate tissue in men with localized prostate cancer.~   "
104679|NCT01686945|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and~     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a~     long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and~     male subjects with type 2 diabetes (T2D).~   "
104680|NCT01686932|"~     Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in~     their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50~     mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding~     postprandial blood-glucose normalization as well as protective properties regarding~     hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic~     patients a correlation has been described between hypoglycemia and abnormal heart function~     (QTc-elongation), which can have severe consequences for the patients. This study aims for~     the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in~     insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of~     hypoglycemic episodes with changes in heart-function measured by Holter-ECG.~      The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than~     sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function~     caused by undetected hypoglycemic episodes.~   "
104681|NCT01686919|"~     Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in~     Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and~     complications who opt for gastric bypass surgery, go through a standard program including~     a thorough clinical examination and information on the operation, followed by a learning and~     coping program that consists of standard dietary advise for weight loss and includes weekly~     visits during 8 weeks.~      This research project concerns a subgroup in the patient population described above:~     morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be~     investigated how an 8 week preoperative milk-free diet affects digestive functions and~     weight loss. It is known that milk may cause stomach complaints and may make it more~     difficult to loose weight.~   "
104682|NCT01686906|"~     To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to~     reduce and stabilize ectasia in eyes with advanced keratoconus~   "
104683|NCT01686893|"~     Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute~     testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients~     An investigator-initiated, prospective, controlled, multicenter study~   "
104684|NCT01686880|"~     The purpose of this study is to assess the safety of transarterial radioembolization prior~     to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma~   "
104685|NCT01686867|"~     The underlying concept behind this feasibility trial is to achieve a reduction in indoor~     smoke from biomass fuels and minimize changes in cooking practices such that it prompts one~     of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel~     sources used in developing countries include wood, dried dung, and agricultural waste. The~     investigators propose to reduce indoor air pollution by replacing the household traditional~     cookstove with an improved design that incorporates the following key elements:~        -  Burner openings customized to the size and shape of the cooking vessels in the home.~        -  Flue designed to draw air into the fire box under the cooking pots and pass it out~          through a chimney.~        -  A chimney with adequate height to create a draft and vented to the exterior.~        -  An exterior port that has bidirectional openings to prevent backflow of smoke.~        -  An access port for the chimney that permits cleaning of soot.~      The investigators propose to use two types of improved cookstoves that meet these criteria.~     As part of piloting activities, the investigators will test several different types of~     commercially-available cookstoves with a chimney, and we may also want to test a~     locally-made improved cookstove. The investigators want to evaluate those designs by~     comparing their ability to reduce indoor air pollution, the reliability between cookstoves~     of the same type, the functioning over time, the logistics of import/build locally,~     preferences and cultural compatibility, and costs. The investigators will select two types~     of improved cookstoves to use in the feasibility trial.~      The study design will be a crossover intervention trial in which all patients will first~     have a run-in observational period of 4 months with the traditional cookstove prior to~     randomization. At baseline, the investigators will obtain sociodemographic information for~     each household, respiratory outcomes and other health data for the participating women, and~     cooking times and practices including the types of fuels used. All 40 patients at each site~     will receive the two types of improved cookstoves, one after the other: 20 will be~     randomized to receive the first type of cookstove with a chimney and the other 20 to first~     receive the second type of improved cookstove with a chimney. The patients will be followed~     for 4 months before the crossover. The investigators will assess cooking behavioral~     practices and compliance with cookstove use monthly, and respiratory and environmental~     measures at the mid-point of the 4 month period to minimize carry-over effects. At the end~     of second 4 month period, the investigators will switch the order of the improved cookstoves~     and follow all participants for another 4 months. The investigators will assess behavior,~     compliance, respiratory and environmental measures as above. The study is expected to~     require 12 months to complete.~   "
104686|NCT01686854|"~     Comparison between different treatments of obesity in the short and medium term:~     prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of~     obesity according to the method of clinical trial.~      According to the Italian guidelines on obesity, the target to reach is the weight loss of~     10% compared to the initial weight, obtained in six months and maintained for the next 5~     years.~      The guideline considers six months as the time required to lose weight, but many patients~     are not able to achieve this result. Since in clinical practice many patients fail to~     achieve this weight loss in six months, it was decided to extend to 12 months the time to~     reach the target. As an intermediate goal it has been proposed to achieve a weight loss of~     at least 5% on respect of the basal weight in six months.~   "
104690|NCT01686802|"~     Children 5-17 years of age who have undergo orthopedic day surgical procedures for~     definitive management of fractures, tendon release, etc. will be randomized to receive~     either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at~     home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We~     hypothesize that oral morphine will result in significantly lower pain scores on the Faces~     Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial~     will create a new option for post-operative pain management in children.~   "
104691|NCT01686789|"~     The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus~     pegIFN) on the SVR in chronic HCV patients.~   "
104692|NCT01686776|"~     This is a prospective, validation study of a extempore made tracer compared with a~     commercial. Studies with tracer have no medical effects but are used for studying human~     physiology, in this case pharmacokinetic variables of endogenous albumin distribution and~     turnover at different levels of inflammation.~        1. Primary Objective:~           - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured~          SERALB-125 give identical values of calculated blood plasma volume and capillary~          leakage measured as transcapillary escape rate of albumin?~        2. Secondary Objective:~             -  How do three different measures of albumin turnover correlate in volunteers?~             -  How do the pharmacokinetic parameters of endogenous albumin vary between the three~               study groups?~   "
104693|NCT01686763|"~     Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after~     subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of~     ET-1 are not sensitive enough to predict the development of vasospasm representing the~     average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a~     technique able to detect molecule concentrations in a small perivascular area. The~     investigators performed a prospective observational clinical study to test the hypothesis~     that MD ET-1 concentrations should be a sensitive predictor for vasospasm.~      Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale~     admitted to the ICU were consecutively studied. All patients received surgery within 48~     hours from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery~     and samples were hourly collected and analysed to measure lactate, piruvate and glutamate~     levels; ET-1 levels in CSF and MD fluids were measured from admission until day 7. At~     admission and after 7 days two angiographies were performed to detect the degree and extent~     of vasospasm, Transcranial Doppler and neurological evaluation were daily performed.~     Patients were then classified according to the presence of vasospasm in 3 groups: absence of~     vasospasm (NV), presence of vasospasm (CV), acute neurological deterioration (AND).~   "
104694|NCT01686750|"~     This is a cluster randomized trial to evaluate the effectiveness of integrated care centers~     (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk~     populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We~     will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in~     India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to~     stratify sites according to key baseline characteristics. We will perform stratified~     randomization to assign sites to either the ICC intervention or to standard services. ICCs,~     which will be either IDU or MSM-focused, will provide an accepting atmosphere in which~     members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and~     testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be~     scaled-up from existing governmental or non-governmental organizations and services provided~     at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After~     providing services in communities for two years, we will conduct an evaluation survey (with~     biological and behavioral measures) of approximately 1000 subjects in the target populations~     in each of the 22 study sites. Integrated care centers have the potential to improve access~     to HIV prevention and treatment services among vulnerable, high-risk populations.~   "
104695|NCT01686737|"~     Breast cancer is the most frequent cancer in women and is associated with profound~     restrictions of health-related quality of life and psychosocial health. More than~     three-quarters of women with breast cancer suffer from fatigue during cancer treatment.~     While exercise interventions can improve fatigue in breast cancer patients, many patients~     request complementary treatment approaches. Therefore, this study investigates the effects~     of yoga in women with breast cancer compared to aerobic exercise and usual care.~      It is hypothesized that yoga is more effective than usual care and equally effective as~     aerobic exercise.~   "
104696|NCT01686724|"~     This study tests the effectiveness of a newly developed integrated school-home behavioral~     intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The~     intervention is implemented by school-based mental health professionals within school~     settings.~   "
104697|NCT01686711|"~     To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with~     diabetes mellitus.~   "
104698|NCT01686698|"~     Probiotics, due to their ability to modulate intestinal flora, intestinal permeability and~     immune response, could decrease bacterial translocation and improve immune system~     alterations in cirrhosis. This could lead not only to improvement in liver function and to~     prevent bacterial infections and other complications but also to improve CD and to avoid its~     consequences falls, HRQoL deterioration).~      Recently, the investigators have observed that VSL#3 administration to rats with~     experimental cirrhosis decreases bacterial translocation, inflammatory response and ascites~     formation, without changes in intestinal flora. This suggests an improvement in intestinal~     barrier that deserves further investigation.~      VSL#3, through decreasing intestinal bacterial translocation and immune system modulation,~     could improve cognitive function and prevent the consequences of CD, including falls and~     HRQoL deterioration, in patients with cirrhosis.~   "
104724|NCT01686360|"~     The purpose of this study is to test the effects of objective risk information about breast~     cancer and mammography outcomes using a randomized control trial. Women between the ages of~     35 and 49 will receive information about their personal risk for breast cancer and be~     randomly assigned to receive data about a woman who should be screened, data about the~     potential outcomes of screening, or data about breast cancer deaths. Two presentation~     formats will be tested and compared.~   "
126397|NCT01401283|"~     This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac~     index trending via a radial arterial line versus standard care in general surgical patients~   "
104699|NCT01686685|"~     Preterm children are at increased risk for autism spectrum disorders, with an estimated rate~     of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore,~     individuals with ASD who were born prematurely form a substantial body of children diagnosed~     with ASD.~      Premature birth confers an insult to the newborn at a neurologically vulnerable stage.~     Prematurity associated changes in oxygen tension can be detrimental to developing organs,~     the brain being one of the most rapidly developing organs in the second half of the~     pregnancy. Changes in oxygen tension mediate activation of proteins that change the course~     of cell development.~      In this study, we plan to measure changes in the expression of 3 proteins that may be~     affected by changes in oxygen level at birth. We will study the interaction between the~     proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2~     years of age. The proteins are:~        1. VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new~          blood vessels during embryonic development.~        2. Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of~          different genes, many with developmentally critical functions.~        3. CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that~          regulates migration of cells to their target destination during embryonic life. CXCR4~          is expressed in areas of the brain and on cells that are known to be associated with~          ASD.~      We hypothesis that changes in oxygen tension in premature babies initiates a cascade of~     events that lead to changes in cell mobility via abnormal CXCR4 expression. This change~     leads to abnormal neurodevelopment.~      The investigators' primary aim is to find if there is a correlation between postnatal levels~     of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The~     investigators' secondary aim is to find if there is a correlation between postnatal levels~     of expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay.~      Methods:~        1. Premature babies will be recruited in the first day post delivery.~        2. Blood samples will be collected at 3 time points during their hospitalization, and the~          expression of HIF-1, CXCR4 and VEGF will be determined.~        3. Infants will undergo a complete developmental evaluation at 18-24 months of age .~        4. Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the~          developmental evaluation.~   "
104700|NCT01686672|"~     This study will demonstrate feasibility and collect pilot data via a pilot randomized trial~     of 20 participants on the effectiveness of a web-based delivery system of behavioral plus~     nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years~     of age that has been found to be efficacious in face to face delivery.~   "
104701|NCT01686659|"~     This is a multi-center cluster-randomized trial with the following Specific Aims:~        -  To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC~          transfusions in patients undergoing surgeries associated with a significant risk of~          bleeding.~        -  To evaluate if patients monitored with continuous noninvasive hemoglobin experience~          less frequent complications and shorter hospital stay compared with patients who are~          not being monitored with continuous noninvasive hemoglobin.~      Accordingly, the study hypotheses are defined as follows:~        -  The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will~          not reduce the RBC transfusions in patients undergoing surgeries associated with a~          significant risk of bleeding.~        -  The secondary hypothesis is that in patients monitored with continuous noninvasive~          hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus,~          there will be less frequent complications compared with patients who are not being~          monitored with continuous noninvasive hemoglobin.~   "
104702|NCT01686646|"~     This study will investigate any improvement in alertness and performance based on cognitive~     function and mood assessment in subjects suffering the common cold, when taking a novel~     paracetamol and caffeine combination verses paracetamol alone.~   "
104703|NCT01686633|"~     This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study~     with three active comparators in subjects with moderate to severe persistent asthma. The~     study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks,~     and a follow up contact period of one week. The total duration of the study is 17 weeks. 990~     subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg~     once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF~     100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects~     will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for~     acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment~     visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).~   "
104704|NCT01686620|"~     The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to~     insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1~     diabetes.~   "
104705|NCT01686607|"~     This multicenter observational cohort study proposes to establish the risks of short and~     long-term outcomes in users of parenteral micafungin and in users of other parenteral~     antifungal agents from 2005 through 2012 with follow-up until 2017.~   "
104706|NCT01686594|"~     The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy~     maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis~     fungoides) patients.~   "
104707|NCT01686581|"~     This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®)~     as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All~     treatment decisions lie with the physician.~   "
104708|NCT01686568|"~     This study is being done to understand the effects of dietary omega-3 fats on insulin~     sensitivity in adult men and women.~   "
104709|NCT01686555|"~     To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with~     Systemic Lupus Erythematosus.~   "
104710|NCT01686542|"~     The study is designed as a randomized control trial. The purpose of this study is to observe~     the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary~     vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.~   "
104711|NCT01686529|"~     The aim of this study was to investigate the efficacy and safety of subconjunctival~     bevacizumab application as an adjuvant therapy for primary pterygium.~   "
104712|NCT01686516|"~     Diffusion MRI employed in functional imaging has the potential to probe directly brain~     activation instead of blood changes like the BOLD technique. The researchers investigated~     these rapid synaptic plasticity changes with visual activation followed by BOLD and~     diffusion functional MRI as well as anatomical (venography, tractography by diffusion)~     features in young and aged subjects.~   "
104725|NCT01686347|"~     The aim of the investigators study is to demonstrate the association between fetal cardiac~     rhythm abnormalies after epidural analgesia and the maternal systemic transfer of~     ropivacaine and/or sufentanil.~   "
104726|NCT01686334|"~     The primary aim of this innovative immunotherapeutic study is to determine whether the~     antileukemic effects seen in our previous phase I/II study can be confirmed in a large~     cohort of patients and whether dendritic cell vaccination can significantly prevent relapse~     and increase survival of AML patients by eradicating minimal residual disease.~   "
128977|NCT01367262|"~     An open-label study being conducted to determine the metabolism and physiological~     disposition of radiolabeled LY2886721 after a single dose in healthy male subjects.~   "
104713|NCT01686503|"~     The purpose of this study is to determine whether a lower dose of inactivated polio vaccine~     (IPV) injected into the skin (intradermal administration) can work equally well or better~     than the standard dose injected into the muscle (intramuscular administration). There are~     more immune cells in the skin than in the muscle, and other vaccines have been shown to~     require a lower dose when administered intradermally. The study is being done in~     participants infected with HIV because HIV-infected people are known to respond less well to~     vaccines than other groups, so it is particularly important to know if IPV might work better~     in HIV-infected people if administered intradermally.~      If it is possible to lower the dose of IPV by intradermal administration, this would make~     inactivated polio vaccine more affordable in the developing countries where it is most~     needed~   "
104714|NCT01686490|"~     The purpose of this trial was to develop the initial sections of a video/DVD cassette that~     provided guidance about mastering stressful situations for patients who had been informed~     that they need an implantable cardioverter-defibrillator (AICD). We adapted the existing~     LifeSkills video (which was already been shown effective in patients with heart diseases) to~     the specific needs of patients with AICD's. Before its development, we held separate focus~     groups with healthcare providers of AICD patients, pre-implantation patients, and~     post-implantation patients. After the video/accompanying workbook was produced, we held an~     additional focus group with patients who had received the video/workbook before receiving~     their AICD.~   "
104715|NCT01686477|"~     Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers~     giving birth preterm are able to provide less than half their baby's milk requirements.~     Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human~     Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical~     outcomes is unknown.~      Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF,~     is very variable in composition. Clinicians who use HDM do so primarily in the hope that~     despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a~     serious, devastating inflammatory disease characterised by bowel death and multisystem~     failure. These are two of the most feared conditions in newborn medicine as described above.~     Landmark nutritional trials in the early 1980's suggest positive effects of human milk on~     insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it~     benefits growth, including brain growth, and improves neurodevelopmental outcome.~      In order to address this crucial question, central to preterm newborn care, a multicentre~     United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to~     achieve sufficient power to evaluate the impact on the short-term outcomes necrotising~     enterocolitis and bloodstream infection, and establish cohorts large enough to address~     long-term metabolic (such as obesity, type 2 diabetes), cardiovascular (such as blood~     pressure) and developmental outcomes. This pilot trial will evaluate the practicability and~     feasibility of such a large multicentre UK randomised controlled trial. In addition to~     evaluating feasibility and to ensure maximal use of resources allocated, this study will~     also assess outcomes that are indicative of long term metabolic health.~      Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM,~     unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age~     with a sample size of 22 in each group. The trial is designed to reflect current preterm~     feeding practice. The trial will take place in neonatal units in London and parent consent~     obtained within 48hr of birth. Permission will be sought for long term follow up, initially~     from parents (later from children themselves). Outcomes will be body composition using~     magnetic resonance imaging and other imaging techniques. This pilot study will specifically~     assess feasibility by testing 1) provision of HDM by Human Milk Banks in London 2)~     acceptability to parents and clinicians using feedback on trial design 3) recruitment to~     target and 4) retrieval of clinical data for all recruited babies form the National Neonatal~     Database.~   "
104716|NCT01686464|"~     The aim of this clinic trial is to testify the efficacy of using new and noninvasive~     therapy, called simultaneous Magnetic and Oxygen Treatment along Meridians and Collaterals~     (MOMC), to treat Bell's Palsy.~   "
104717|NCT01686451|"~     Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed~     for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD).~     Several studies, including one randomized, double-blind, placebo-controlled clinical trial,~     have suggested that the use of statins is more frequently associated with fatigue. And~     XueZhiKang may be not. The purpose of this study is to compare the effect of these two~     medications on fatigue in persons who are at moderate to low CVD risk based on the risk~     estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis~     Society) guidelines (2011) for the management of dyslipidemias.~   "
104718|NCT01686438|"~     Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD).~     Treatment of insomnia with a specialized type of psychotherapy has been shown to be more~     effective than treatment with medications. Unfortunately, few psychologists are trained to~     provide this treatment, limiting Veterans' access to care, especially those Veterans in~     remote and rural areas. This project will evaluate the ability to deliver this psychotherapy~     to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic~     insomnia will receive the psychotherapy treatment either by meeting in-person with the~     psychologist or by the psychologist delivering the treatment by video teleconferencing.~     Finding that video teleconferencing is a cost effective way to deliver this treatment could~     add an important new component to the care of Veterans with PTSD that provides an~     alternative to medications.~   "
104719|NCT01686425|"~     Patients with obstructive jaundice due to locally advanced/metastatic malignancy with~     dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology~     and Hepatology at the University Hospital of Leuven.~      This population will have failed ERCP or will be considered when ERCP is not possible due to~     altered surgical anatomy.~      Patients will be randomized to either PTC or EUS guided biliary drainage~   "
104720|NCT01686412|"~     This is an exploratory study, national, unicentric, double-blind, to be conducted at the~     Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect~     possible autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy~     (EEFLE) in healthy subjects and in patients with advanced hepatocellular carcinoma or in~     patients with advanced breast carcinoma. Autonomic responses have been described in patients~     with cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to~     exposure to EEFLE seems to be associated with a specific set of modulation frequencies when~     applied to patients with malignancies. Moreover, healthy individuals exposed to modulated~     EEFLE a specific set of frequency do not appear to autonomic response. Biofeedback is~     defined by a change in amplitude of the radial pulse during exposure to EEFLE, modulated~     according to a set of specific frequencies. This phenomenon is not yet fully elucidated. In~     exploratory survey of one patient was observed a change of the pressure pulse immediately~     after the start of and during exposure to EEFLE, modulated according to a set of specific~     frequencies recorded by digital photoplethysmography. This study aims to evaluate an~     autonomic response in individuals exposed in a single moment, by electromagnetic fields.~     This study does not intend to study a diagnostic or therapeutic procedure. For this reason,~     evolutive clinical data will not be considered during and after the study.~   "
104721|NCT01686399|"~     The aim of this protocol is to use a multidisciplinary approach to convey nutrition and~     activity messages to randomly selected Hadassah Medical Center employees. The intervention~     will be for one academic year and include frontal talks, email and internet focus group~     interactions, public demonstrations and a focused intervention within the hospital kitchen.~      The outcomes are specific parameters of dietary modifications, degree of physical activity~     and health related perspectives. Outcomes will be recorded at baseline and by the end of the~     intervention ( one year).~   "
104722|NCT01686386|"~     This is an open Label, Phase I/II, multicenter study. In the first phase it defines the~     maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L)~     and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity~     of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in~     relapsed multiple myeloma patients.~   "
104723|NCT01686373|"~     The purpose of this study is to assess the changes in language processing of patients with~     chronic, post-stroke aphasia following the application of brain stimulation. The brain~     stimulation the investigators administer is called transcranial direct current stimulation~     (tDCS). It involves passing a weak electrical current through the brain between two~     electrodes in the form of damp sponges. One sponge will be placed over a specified area on~     the damaged left hemisphere, while the other sponge will be placed on the right scalp.~     Computer-controlled speech-language treatment will be administered during the application of~     tDCS.~   "
104727|NCT01686321|"~     Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's~     lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies~     have investigated the role of bendamustine in the treatment algorithm. The aim of the~     current B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment~     of bendamustine and subcutaneous rituximab in old patients or in elderly patients with high~     comorbidity who do not qualify for a CHOP like treatment. The results of this study will~     form the basis of a larger, prospective randomized phase III trial.~   "
104728|NCT01686308|"~     Cataract is globally the most common cause of blindness and in Denmark the operation with -~     50.000 treatments per year - is the most common eye operation. The cause of cataract is~     growth and denaturation of the lens proteins. This leads to an increased absorption of blue~     light and increased light scatter. This may affect newly discovered cells in the retina that~     are involved in the regulation of the circadian rhythm. When the internal circadian rhythm~     is not synchronized with the external day and night a phase-shift occurs. Most people know~     of this discomfort as jet-lag, but the consequences may be much more severe such as heighten~     risk of cancer and cardiovascular disease.~      The goal of this project is to study how the circadian regulating cells of the retina is~     affected by cataract and by the operation. Cataract patients are studied before and after~     the operation with questionnaires, hormone and activity measurements and with a specialized~     pupil measurement that measures the indirect response of the circadian regulating cells to~     blue light.~      Results from this study aim to shed light on the regulatory mechanisms of the eye on the~     circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular~     lens is evaluated. This may have impact on clinical practise especially with regard to~     choice of intraocular lens and widened indications for cataract surgery.~   "
104729|NCT01686295|"~     The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation~     System when used as directed in promoting hair growth in men and women with androgenetic~     alopecia~   "
104730|NCT01686282|"~     Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S.~     Americans have been more concerned about their blood cholesterol levels and dietary~     cholesterol intakes rather than their overall cardiovascular health risk factors leading to~     CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and~     vegetables and physical activity. Statistics show that approximately 91% of individuals with~     CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction~     leading to increased arterial stiffness.~      The investigators long-term goal is to provide feasible and effective dietary ways for pre-~     and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve~     vascular function and thereby reducing their cardiovascular risk and enhancing the quality~     of life. Blueberries are a rich source of phenolic compounds and these compounds may play an~     important role in promoting cardiovascular health. Considering the strong possibility that~     phytochemicals present in blueberry work additively or synergistically, it would be ideal to~     investigate the cardioprotective effects of blueberry as a whole. The investigators overall~     objective to bring forth evidence that blueberry consumption will reduce BP and~     cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and~     autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The~     investigators hypothesize that blueberry supplementation will improve vascular function and~     will lower blood pressure in postmenopausal women with pre-hypertension. The findings of~     this study will provide a foundation for disseminating feasible, safe approaches for~     preventing and combating hypertension at its early stage which does not require drug~     therapy.~   "
104731|NCT01686269|"~     Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has~     an impact on multiple and diverse disciplines, including cardiology (coronary restenosis),~     cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft~     failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and~     transplant medicine (chronic allograft rejection in hearts and kidneys). [1] In marked~     contrast to the deleterious effects of smooth muscle progenitor cells on neointimal~     hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an~     important role in vascular repair and in the inhibition of neointimal hyperplasia. [2]~     Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to~     neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and~     CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute~     ischemic event in humans. [3] Reduced levels of circulating EPCs independently predict~     atherosclerotic disease progression, thus supporting an important role for endogenous~     vascular repair to modulate the clinical course of coronary artery disease. [4] These~     observations prompt the hypothesis that circulating EPCs may provide an endogenous repair~     mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional~     endothelium perioperatively. Therefore, the investigators examined whether levels of~     circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery~     to establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.~   "
104732|NCT01686256|"~     A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium~     Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.~      Phase I - The proposed indication for FolateScan is disease or pathological assessment of~     ovarian or endometrial masses.~   "
104733|NCT01686243|"~     The aim of this study is to demonstrate the feasibility of a new technique using real time~     ultrasound guided paramedian approach to the epidural space. This approach will use~     transverse view of the spine utilizing curvilinear low frequency ultrasound probe Sonosite~     S nerve and echogenic 17G touhy needles  Pajunk TouhySono~      The investigators believe that this new technique is helpful to get the best anatomic~     landmark for epidural catheter placement using the real-time ultrasound.~      Measurable outcomes:~        -  Block performance time.~        -  Block success rate.~        -  Needle Depth to epidural space~      Block success rate will be measured as the rate of cases that will have succesful insertion~     of the epidural catheter using ultrasound guidance and the case is done completely under~     epidural anesthesia.~      All cases that will be converted to general anesthesia will be counted unsuccessful.~      Other measurable outcome data that will be collected will include needle depth to the~     epidural space, and ultrasound measured depth to the lamina~   "
128978|NCT01367249|"~     This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.~   "
104737|NCT01686191|"~     Kidney disease is a common problem after heart transplantation. It may be caused by~     anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some~     people develop kidney problems after a heart transplant, but other people do not, is not~     fully known. This study plans to learn more about the relationship between a person's~     genetic make-up (DNA) and the risk of kidney problems after a heart transplant. The~     long-term goal of this research is to identify genetic variations that may help predict the~     development of kidney problems after heart transplantation.~   "
104738|NCT01686178|"~     The goal of the study is to implement and evaluate interventions to decrease smoking among~     young adults attending bars and nightclubs. It is believed that the proportion of young~     adult current smokers during and after the intervention will be significantly less than the~     proportion of young adult smokers before the intervention in each of the study cities.~   "
104739|NCT01686165|"~     This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in~     combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on~     patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the~     laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to~     cause either death of the cancer cells or prevention of their growth. In human studies with~     a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and~     slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are~     destroyed and this may result in the disappearance of the tumor (remission)~   "
104740|NCT01686152|"~     To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and~     Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic~     keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy~     of each of the two active treatments is superior to that of the Vehicle cream.~   "
104741|NCT01686139|"~     Diabetes Mellitus (DM) can be regarded as one of the epidemics of the western world.~      DM contributes to severe morbidity and mortality due to damage in the target organs~     (neuropathy, vasculopathy, nephropathy, retinopathy).~      It affects the quality of life of the patients because of increased rate of blindness, IHD,~     stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic~     Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic~     patients due to neurological damage and / or different levels of Peripheral Vascular Disease~     (PVD). Diabetic foot complications are the most common cause of lower extremity amputations~     in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in~     diabetic patients.~      Between 15% - 25% of the foot ulcers will lead to lower limb amputations.~      It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many~     diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and~     critical limb ischemia.~      Stem cells can be obtained from either the patient (autologous) or non-related healthy~     donors (allogeneic).~      The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow~     Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg~     wounds of diabetic patients.~   "
104742|NCT01686126|"~     Currently the standard treatment for early stage endometrial cancer or endometrial~     hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and~     removal of both ovaries. While highly effective, this surgery carries significant side~     effects for:~        -  young women who still wish to have children and would lose fertility; and~        -  women with one or more disorders (or diseases) in addition to the early stage~          endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are~          at risk for surgical complications making surgery unsafe.~      This study will access a new approach to the treatment of endometrial cancer to spare women~     of having to undergo major surgery that may be unwanted or unnecessary.~      Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent~     thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen~     replacement therapy (HRT). However it is not approved to treat early stage endometrial~     cancer or endometrial hyperplasia with atypia. This research project will test to see if~     Mirena is an effective treatment for early stage endometrial cancer and endometrial~     hyperplasia with atypia.~      Metformin is approved in Australia to treat Diabetes. However it is not approved to treat~     early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an~     experimental treatment for early stage endometrial cancer and endometrial hyperplasia with~     atypia. This means that it must be tested to see if it is an effective treatment for early~     stage endometrial cancer and endometrial hyperplasia with atypia.~      Weight loss interventions are feasible and safe, and already being implemented by~     gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight~     induces a large biological effect (for example reduces incidence of diabetes by 58%, and~     hypertension by 26%).~   "
104743|NCT01686113|"~     This study will examine whether or not short, daily exposures change a person's ability to~     detect free fatty acids in a solution by its taste. Repeated exposure should improve a~     person's ability to detect free fatty acids.~   "
104744|NCT01686100|"~     Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients~     with coronary artery disease. This is done by using alternative blood vessels (grafts) to~     bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where~     surrounding tissue is removed, this may damage the vessel and influence its patency.~      The no-touch technique was developed by Professor Domingos Souza at the Department of~     Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes~     taking out the vein with its surrounding tissue and by this way the vessel is less damaged.~     The first two follow ups have shown that no-touch grafts had better patency than~     conventionally extracted graft at 18 months and 8.5 years.~      This long term follow up is a continuation of the randomized trial started in 1993 where the~     patency and incidence of stenoses in the no touch and conventional vein grafts has been~     studied.~   "
104745|NCT01686087|"~     The goal of this study is to understand whether patients with obsessive-compulsive disorder~     (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral~     therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if~     they first do well with EX/RP.~   "
104746|NCT01686074|"~     This project is a comprehensive study, with main focus on motor control, comparing patients~     with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome~     (FMS). Focus of the present project will be on detailed movement analysis in a movement~     laboratory and involve functional tasks such as walking and standing. Investigations will~     also comprise muscle activity, reaction time and fine motor control.~   "
104747|NCT01686061|"~     The purpose of this survey is to collect detailed information on patients treated for~     blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including~     how often they are treated with botulinum toxin, how long their treatment lasts, how~     satisfied they are with their treatment, and if there is any improvement in their symptoms~     with the treatment.~   "
107530|NCT01649375|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     ankylosing spondylitis who are tolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor~   "
104748|NCT01686048|"~     Ambrosia is known for its allergenicity in the USA causing hay fever and asthma. Israel has~     always been considered clean of Ambrosia but over the past years growth of Ambrosia plants~     has been detected in several locations in Israel.~      In the proposed study, patients referred for routine allergic evaluation will also be skin~     tested with Ambrosia allergens, in addition to their regular prick skin tests with all other~     airborne allergens.~   "
104749|NCT01686022|"~     Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor~     or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of~     grass or weed are different in various part of the world. The allergens from grass and weed~     has never been studied in Thailand. This study will find the major allergen from Bermuda~     grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In~     addition, the investigators will study about the cross-reactivity among these group of~     allergen.~   "
104750|NCT01686009|"~     The provision of analgesia to patients in pain is a fundamental necessity of emergency~     department practice and is usually accomplished using IV opioids. However, significant~     barriers exist to the provision of timely analgesia by the IV route.~      The use of the IN route for medication delivery provides an efficient and relatively~     painless mode of analgesia delivery. As well, ketamine is well-known to be an effective~     analgesic and to preserve cardiorespiratory function thus removing the necessity of~     physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN~     route provides a rapid, easy-administered and well-tolerated method for providing analgesia~     in the ED setting.~   "
104751|NCT01685996|"~     About 20.6 % of the US population smokes cigarettes. This group includes nicotine dependent~     smokers who are resistant to current smoking cessation treatments. Varenicline is a smoking~     cessation medication found in meta-analytic reviews to be superior to other smoking~     cessation treatments, but 56% of patients who take varenicline do not quit. One strategy to~     increase quit rates may be to administer a second medication to augment the efficacy of~     varenicline. The anti-epileptic medication zonisamide is a good candidate for adjunct~     treatment as it increases dopaminergic tone, normalizes glutamate homeostasis, potentiates~     GABA release. Zonisamide improves sleep and promotes weight loss, two prominent issues not~     addressed by varenicline. Finally, the PI of this proposal has documented unpleasant changes~     in the taste of cigarettes and reductions in nicotine withdrawal among smokers receiving~     zonisamide as part of another clinical trial. The proposed study will explore the efficacy~     of varenicline + zonisamide for smoking cessation in a controlled, clinical trial. Eligible~     participants (n=60) will be smokers (>10 cig/day for >1 year) seeking treatment. They will~     be randomly assigned to receive varenicline + double-blind zonisamide or placebo for a~     10-weeks. Participants will visit the clinic weekly to receive medications and smoking~     cessation counseling and to complete self-report questionnaires. Smoking status will be~     assessed via weekly urinalysis testing for cotinine (abstinence: <200ng/ml). Cotinine is a~     sensitive indicator of smoking status with a longer half-life then carbon monoxide (CO) and~     is more likely to detect low or intermittent smoking. The study hypothesis is that~     participants who receive the combination zonisamide + varenicline will achieve greater~     smoking abstinence compared to varenicline alone. The primary outcome measure will be the~     4-week rate of biochemically-confirmed continuous smoking abstinence during weeks 7-10.~     Secondary outcomes will include self-reported rates of smoking, subjective effects of~     cigarettes, weight change from baseline to week 10, sleep quality, and nicotine withdrawal~     severity. This study will advance the science and clinical treatment of smoking cessation,~     and will provide the prerequisite data to develop a larger scale clinical trial evaluation~     of the combination zonisamide + varenicline for smoking cessation.~   "
104752|NCT01685983|"~     The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral~     abiraterone acetate and oral prednisolone in men with metastatic-castration resistant~     prostate cancer (mCRPC) and with disease progression following treatment with a~     docetaxel-containing chemotherapy.~   "
104753|NCT01685970|"~     Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel~     preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may~     enhance patient tolerability and have similar bowel cleansing efficacy compared to standard~     method using high volume split-dose PEG.~      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation~     protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)~     split-dose for afternoon colonoscopy.~   "
104754|NCT01685957|"~     Recent decades have shown an alarming increase in obesity. Obesity is associated with high~     costs for both the individual and for society. It is therefore important to prevent and~     treat obesity. The investigators believe that if you add a self-help weightloss book and~     teach cooking skills to a standard dietary treatment, then it will result in greater weight~     loss than with dietary treatment alone. However, this has not yet been studied. Since it~     will require more resources, it is important to investigate whether it also works better~     before changing the current treatment.~      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and~     cooking classes are more effective than dietary treatment alone in changes in body weight~     and body composition in obese persons over a period of 12 months. There is no difference if~     the intervention are based on the national dietary guidelines or a relative low-gi and~     high-protein diet.~      Secondary to investigate the impact the interventions have; on diet quality and quantity, on~     markers of metabolic syndrome and on how many subjects complete the study.~   "
104755|NCT01685944|"~     This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body~     fat and body weight in subjects with BMI 25-30 kg/m2.~   "
104756|NCT01685931|"~     The purpose of this study is to assess the effectiveness, safety and tolerability of~     flexibly dosed paliperidone palmitate in patients with schizophrenia previously~     unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.~   "
104757|NCT01685918|"~     Study objectives~        1. Comparison of drug persistency rates between elderly RA patients and young RA patients~          with biological DMARDs~        2. Analysis of discontinuation reasons & influencing factors of drug discontinuation in~          elderly RA patients and young RA patients~        3. Comparison of the occurrence of adverse events & treatment outcomes between elderly RA~          patients and young RA patients~   "
104758|NCT01685905|"~     The purposes of this study~        1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G),~          and determine the level of agreement between two tests in patients with rheumatic~          diseases~        2. to evaluate the difference in the occurrence of active TB in patients who receive both~          QFT-G and TST compared with those who receive only TST for detecting of Latent~          tuberculosis infection(LTBI) who are candidates of TNF inhibitors.~   "
104827|NCT01685008|"~     This is an open-label, multicentre study to characterize the safety and preliminary efficacy~     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory~     non-Hodgkin´s lymphoma (NHL) who have received at least 1 prior therapy containing rituximab~     (at least once).~   "
129367|NCT01362114|"~     In this randomized, double blinded, Placebo-control Trial, the investigators planned to give~     Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.~   "
104759|NCT01685892|"~     This multi-center, open-label, dose-finding study will evaluate the safety and~     pharmacokinetics of venetoclax (GDC-0199; ABT-199) administered in combination with~     obinutuzumab to participants with relapsed/refractory or previously untreated chronic~     lymphocytic leukemia. All participants (relapsed/refractory and previously untreated) will~     receive 6 cycles of obinutuzumab and venetoclax. After completing combination treatment,~     previously untreated participants will receive single agent venetoclax for at least 6~     additional months (the anticipated time on treatment for previously untreated participants~     is at least 12 months). After completing combination treatment, relapsed/refractory~     participants will continue single agent venetoclax until disease progression.~   "
104760|NCT01685879|"~     Certain types of rice have more dietary fiber than others. This type of rice is known a~     high amylose rice. This study hypothesizes that high-amylose rice, will decrease blood~     glucose and insulin responses after consumption compared to conventional rice in healthy~     adults, ages 18-40. Eighteen healthy men and women will participate in this study. This~     study will determine how high blood glucose and insulin values rise after eating a portion~     of rice. This study will also evaluate hunger ratings after consuming rice. The results of~     this study will help researchers better understand how diet can influence diabetes~     management.~   "
104761|NCT01685866|"~     Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see~     peripheral veins in children having forecasted difficult venous access and could facilitate~     the venous access.The main goal is to reduce the time necessary to get a venous access~     during the inhalation anesthesia induction.~   "
104762|NCT01685853|"~     The present study is intended to evaluate the effectiveness, tolerability, compliance, and~     feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L~     Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of~     colonoscopy, vs the standard 4L split PEG solution.~   "
104763|NCT01685840|"~     The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy~     compared with usual care in high risk patients with left ventricular systolic dysfunction.~   "
104764|NCT01685827|"~     This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral~     treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared~     to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not~     inferior to NECT treatment.~   "
104765|NCT01685814|"~     The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD)~     as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being~     considered a novel standard as an induction protocol, since response in general occurs~     early after starting treatment we decided to choose three cycles of either induction~     regimen.~      Together with the novel compounds, tandem high-dose melphalan is still the standard of~     care; it seems desirable to re-address the question of the number of transplant (single vs.~     double high-dose melphalan) procedures required in the context of triplet-induction~     protocols utilizing at least one of the novel compounds.~      Thus, the question to be asked in the current protocol is whether immediate lenalidomide~     maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will~     result in identical progression free survival (PFS) when compared to tandem high-dose~     melphalan with deferred maintenance therapy.~      Despite induction with novel compounds, approximately 25 - 40% of patients will be in less~     than very good partial response. Very recently, achievement of less than VGPR was confirmed~     to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic~     stem cell transplantation is considered the standard of care in patients with suboptimal~     response to a first autograft.~      In the current protocol, the standard for favourable responders (tandem-autologous~     transplant) is combined with 3 years of lenalidomide maintenance. This approach will be~     investigated for patients with less than VGPR following a first autotransplant and compared~     to the current standard of intensification in poor responders (allogeneic transplantation).~   "
104766|NCT01685801|"~     This study is a multiple within participant crossover study to evaluate the effect of~     ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF)~     who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator~     (CFTR) function.~   "
104767|NCT01685788|"~     The overall aim of the project is to gain insight in sensory deficits and recovery patterns~     in the upper limb post stroke and its association with brain lesion localisation.~     Furthermore, the investigators will identify associations of deficits in sensory modalities~     with upper limb impairments, activities and participation at different time points after~     stroke. Identification of the sensory deficits, along with further insights in their~     relation with objective neurophysiological and neuroanatomical measures will contribute to~     the amelioration of goal-setting for the rehabilitation of upper extremity function after~     stroke. These functions are indispensable during several daily activities as well in~     different sports and leisure activities. This project is an important step towards a better~     delineating of treatment interventions for the upper limb and to a better guiding of~     individual needs for post-stroke treatment in the future.~   "
104768|NCT01685775|"~     Laparoscopic surgery has become the golden standard for the removal of the gallbladder.~     Recently, developments have been made so that operations can be performed through a natural~     orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study~     compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation~     using 2-3mm instruments in female patients. It also examines the benefits and disadvantages~     related to postoperative pain, cosmetic aspects, and potential physiological alterations to~     the transvaginal approach that affect sexual intercourse.~   "
104769|NCT01685762|"~     The purpose of this study is to see if metformin will be effective in making endometrial~     hyperplasia without atypia better by returning the tissue to a normal state.~   "
104790|NCT01685489|"~     This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day~     lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by~     the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for~     three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to~     allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK)~     analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and~     cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3,~     and 15 of PSK/placebo lead-in and during cycles 1 and 4.~   "
104770|NCT01685749|"~     Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in~     the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,~     resulting in a barbed stinger injecting venom into the victim. Little exists in the current~     literature on the natural history of stingray injuries. Most of the existing literature~     looks at the incidence of stings, and to a certain extent the demographic of people who seek~     care. To our knowledge no study has attempted to collect a more inclusive population of~     those people who are stung and follow them prospectively to determine the incidence of~     medical intervention, infection, etc.~      This study aims to describe and quantify the natural history of stingray injuries and to~     better understand their time course and medical requirements. The study setting will be Seal~     Beach, which reports some of the greatest number of annual stingray injuries for any single~     beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who~     are believed to treat the majority of stingray injuries suffered at the beach. Eligible~     persons will be consented for participation over the phone by research personnel. If~     enrolled in the study they will receive a phone call by research personnel one week and one~     month after the injury that will collect information about the symptoms they have~     experienced and the medical interventions they have received, if any. This study is strictly~     observational in nature and will not involve any interventions on the part of study~     personnel or alter the manner in which or types of medical assessments or treatments.~   "
104771|NCT01685736|"~     Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements,~     24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that~     allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3~     nights, 3 readings/night).~   "
104772|NCT01685723|"~     Background: Smoking cessation can largely improve cancer prognosis and quality of life among~     cancer patients. However, few patients are aware of the importance to quit at the stage, or~     they have difficulties to quit by self.~      Aim: Test the effectiveness of a tailored and targeted smoking cessation intervention~      Hypothesis: We hypothesize that improving risk communication could significantly increase~     the quit rate of smoking cancer patients~      Design: Cluster randomized controlled trial~      Setting: Outpatient clinics in Queen Mary Hospital and Tuen Mun Hospital (Clinical Oncology~     Departments)~      Subject: Smoking patients who have diagnosed cancer with stable condition and treatments~      Intervention: At baseline, intervention group receives:~        1. health warnings of smoking from oncologists/nurses based on a special design leaflet;~        2. a patient-centred counseling from nurse counselors with emphasis on risk perceptions of~          smoking to cancer prognosis; and~        3. examination of exhale CO level. They will receive up to 8 more telephone counseling~          within 1 month by nurse counselor to reinforce the importance to quit and assist to~          solve any barriers. Control group receive standard care and a generic self-help smoking~          cessation booklet.~      Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month~     follow up. Secondary outcomes include:~        1. change in risk perceptions of smoking;~        2. change in the intention to quit;~        3. validated 6-month quit rate;~        4. patient's smoking reduction by at least 50% compared to baseline;~        5. quit attempt(s);~        6. change in health related quality of life; and~        7. cancer recurrence rate at 6-month.~      Significance: This study develops and validates practical smoking cessation interventions~     targeted to cancer patients to improve their cancer prognosis and in long-term, increase~     their survival time.~   "
104773|NCT01685710|"~     The aim of the study is to determine whether the application of a glyceryl trinitrate patch~     (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that~     they can be used.~   "
104774|NCT01685697|"~     Most premature babies have difficulty breathing at birth and need help (what we call~     resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation~     device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we~     call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.~      To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth~     and nose. The clinical team tries to achieve a good seal between the face and the mask. A~     problem of mask ventilation is that air can escape between the mask and the face (what we~     call mask leak). Currently, two different types of facemasks (Laerdal mask or Fisher &~     Paykel mask) are routinely used in the delivery room at The Royal Alexandra Hospital.~      The purpose of this study is to find out if one facemask is leaking less between the face~     and the mask.~   "
104775|NCT01685684|"~     The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared~     with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic~     low back pain requiring around-the-clock opioid analgesia for an extended period of time.~   "
104776|NCT01685671|"~     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after~     SC administration in health male volunteers~   "
104777|NCT01685658|"~     The main objective of this study was to demonstrate the non-inferiority of intravenous~     paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency~     ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30~     minutes.~   "
104778|NCT01685645|"~     The pupillary pain-meter AlgiScan ® with integrated nociceptive stimulator is a portable,~     battery-operated device which automatically measures, by means of an infrared camera, pupil~     diameter. This is measured in response to noxious stimulation produced by a tetanus at a~     frequency of 100 Hz for 5 seconds. Its intensity varies from 10 to 60 mA. The recording is~     performed for a period of 13 seconds (3 seconds prior to stimulation, stimulation for 5~     seconds, 5 seconds after the stimulation). An interval of 3 minutes is allowed between the~     two measurements (right and left), which is significantly higher than the time necessary to~     return to normal (about 20seconds).~      The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure of the~     pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller~     scores indicate increased analgesia.~      The main objective of this study is to determine whether PPI index variation can determine a~     prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block~     before incision. The measurements are performed after bilateral nociceptive stimulation~     (blocked side versus non-blocked side) in patients under general anesthesia for major knee~     surgery.~   "
104812|NCT01685203|"~     The purpose of this study is to evaluate the safety and efficacy of co-administration of~     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as~     ombitasvir) in adults with chronic hepatitis C virus infection.~   "
104877|NCT01684358|"~     This unblinded, randomized controlled trial (RCT) among women to determine:~      1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women~     who receive a contraceptive implant immediately at baseline during three months of follow up~     compared to women who receive the implant at the three month follow-up visit.~   "
104878|NCT01684345|"~     The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of~     active non-infectious intermediate, posterior, or pan- uveitis.~   "
104779|NCT01685632|"~     Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment~     of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program~     demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the~     disease. From a clinical point of view, within the first 24 hours after IPCH, patients~     undergo a systemic inflammatory response syndrome, and therefore require to be monitored in~     an intensive care unit. From a metabolic perspective, preliminary data have been shown a~     significant anaerobic style disturbance of energetic metabolism, suggesting a deep~     cellular energetic deficit throughout IPCH process.~      Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular~     toxicity due to heat and on the other hand the initiation of a stress protein response (heat~     shock response) which helps to reduce the cell injuries, leads to conduct a research project~     on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of~     high relevance.~      The primary goal is a multimodal assessment of the IPCH-related cell modifications:~     signaling pathways, apoptosis and antitumoral immune response.~      The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to~     baseline values, apoptosis and immune response before/after IPCH.~      The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per~     surgery.~   "
104780|NCT01685619|"~     This clinical study will provide the study specimens (samples of bone marrow and blood) and~     the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML~     Research Consortium. The goal of this project involves the evaluation and potential~     validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid~     leukemia (AML), as well as an analysis of health economic and socio-ethical implications~     related to the potential introduction of these tests into the clinical setting. The~     over-arching goal is to improve the outcomes of patients with MDS and AML. The primary~     hypothesis is that one or more of the laboratory tests being evaluated in conjunction with~     this study, either alone or in combination with other laboratory tests (either established~     or under investigation in this project), will have statistically significant prognostic~     value either alone or in combination with established clinical risk factors.~      The clinical study will involve the enrollment of 200 adults with AML and 200 adults with~     MDS over a 2.5 year period. Participants will be followed on study for two years. Bone~     marrow and blood specimens will be collected at diagnosis and at other time points as~     required for the development of the five laboratory tests.~      Participants will be assigned to treatment according to local institutional practice and~     will be followed for up to 2 years. Health economic and quality of life questionnaires will~     be administered at key time points. Data will be collected regarding participant~     characteristics, diagnosis, disease features, treatment and clinical outcome.~   "
104781|NCT01685606|"~     The study of whether an infusion of blood cells called lymphocytes from a donor can~     stimulate the immune system to fight your leukemia/lymphoma.~   "
104782|NCT01685593|"~     We conducted a controlled randomized trial examining the ability of the Mott abdominal~     Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy~     patients~   "
104783|NCT01685580|"~     Surgical treatment is the standard treatment for localized forms of lung cancer non-small~     cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is~     a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing~     this procedure is a major public health issue. The non-invasive ventilation is a technique~     commonly used postoperatively in acute respiratory distress and in the treatment of sleep~     apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the~     non-invasive ventilation achieved during 7 days minimum before the intervention could~     significantly reduce postoperative complications in patients with an obstructive or~     restrictive disorder, obesity or chronic heart failure.~      The aim of the study is to demonstrate that the non-invasive ventilation in two pressure~     levels achieved during at least 7 days before surgery lung resection (lobectomy or~     segmentectomy) halved the pulmonary and cardiovascular postoperative patients with~     obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.~   "
104784|NCT01685567|"~     The purpose of this study is to evaluate the safety and effectiveness of the MICHI™~     Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection~     during carotid artery stenting. It will be used in conjunction with a FDA approved carotid~     artery stent for the treatment of carotid artery disease.~   "
104785|NCT01685554|"~     The aim of our study was to evaluate the effect of different temperature regimens of~     cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical~     correction of acquired heart diseases.~   "
104786|NCT01685541|"~     The electronic medical record (EMR) offers a new method to provide patients with information~     about their visits with a clinician. The EMR can generate personalized and patient specific~     handouts at the end of the visit that can recap the topics covered during that visit. These~     After Visit Summaries (AVS) can be automatically generated with information contained in the~     patient's chart. The AVS has the potential to improve patient retention of information~     needed for adherence to treatment plans, and follow-up instructions, and to facilitate~     information transfer between healthcare settings. However, the content and formatting of the~     AVS to optimize patients' information retention and satisfaction with the visit is not~     known. In this study, we will develop and test in a randomized trial three different~     versions of an AVS to determine the AVS content that maximizes patient satisfaction and~     retention of information on the AVS,and adherence to physician instructions. The three~     versions of the AVS developed from patient and physician input will be compared to a control~     condition which consists of current practice in each setting.~   "
104787|NCT01685528|"~     The purpose of this study is to determine the feasibility and acceptability of providing~     evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression~     via telephone to rural Veterans receiving home-based primary care.~   "
104788|NCT01685515|"~     The purposes of this study are to observe if oral tetrahydrouridine and decitabine can~     increase fetal hemoglobin levels and improve the symptoms of sickle cell disease, and to~     monitor how patient's bodies react to oral tetrahydrouridine and decitabine.~   "
104789|NCT01685502|"~     The objective of this study is to assess the efficacy and safety under practical use of~     Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1~     year observation period.~   "
104791|NCT01685476|"~     In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing~     and treating several conditions. Physicians having to manage cases of head trauma, stroke~     and hydrocephalus need to assess the time course of ICP, yet they are often unwilling to~     implement invasive monitoring beyond the acute stage, on account of high septic risks.~     Standard techniques include direct ventricular manometry or measurement in the parenchyma~     with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical~     methods for gaining access to pressure changes is an important challenge. Fluctuations of~     ICP are transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The~     Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the~     intra-labyrinthic pressure modify the functional activities of the outer hair cells in the~     cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,~     which is detected as modifications in cochlear activities. Cochlear activities' recording~     are non-invasive and technically simple. A probe is gently inserted into the outer portion~     of the external ear canal.~      The objective of this study is to assess prospectively the accuracy and the precision of a~     new method for ICP monitoring (using cochlear activities) compared with invasive gold~     standard CSF pressure monitoring.~   "
104792|NCT01685463|"~     Specific Primary Aims include:~      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the~     cortical excitability and to inhibit meth cue craving in meth dependent population. The~     investigators anticipate that meth elevates cortical excitability measured by motor~     threshold, causes changes of cortical silent period, and RC. The investigators also~     anticipate that paired pulse measures (short-interval intracortical inhibition,~     short-interval intracortical facilitation and long-interval intracortical inhibition) will~     be different from healthy control, which are more directly linked to glutamatergic cortical~     facilitation and GABAergic inhibition, respectively.~      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will~     use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to~     reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue~     craving in meth dependent population compared with sham rTMS.~   "
104793|NCT01685450|"~     The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal~     fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases.~     Continuous ICP monitoring has an important place in neuro-intensive care for patients with~     severe head trauma and severe meningeal hemorrhage.~      Until now the assessment of ICP requires invasive methods, with a pressure transducer either~     within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is~     performed in a neurosurgery department. These invasive methods have also disadvantages:~     highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the~     development of a non invasive method. The Biophysics Laboratory (School of Medicine of~     Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional~     activities of the outer hair cells in the cochlea.~      Cochlear activities' recording is non-invasive and technically simple. A probe is gently~     inserted into the outer portion of the external ear canal.~      Anatomical studies showed communication between the subarachnoid spaces and the~     perilymphatic compartment by the cochlear aqueduct. Thereby, increases in ICP are~     transferred to increases in intra-cochlear pressure, which is detected as modifications in~     cochlear activities.~      CSF dynamic tests, as constant flow infusion test, are conducted in patients in the~     diagnosis of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through~     a lumbar needle, into the CSF space at a constant rate, and the corresponding rise in ICP is~     registered and analyzed.~      The objective of this study is to assess prospectively the accuracy and the precision of a~     new method for non invasive ICP measurement (using cochlear activities) compared with~     invasive gold standard CSF pressure measurement during CSF dynamic tests.~   "
104794|NCT01685437|"~     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in~     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21~     days before the initial injection of study drug in the first treatment cycle. Enrollment~     will include all subjects who meet the eligibility criteria and who received placebo and~     completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.~   "
104795|NCT01685424|"~     This postmarketing study was conducted to describe prescribing patterns for etoricoxib~     (ARCOXIA®) in General Practice and describe the incidence of selected adverse events~     recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency~     (MHRA) General Practice Research Database (GPRD).~   "
104796|NCT01685411|"~     This is a treatment guideline to allow routine clinical data to be collected and maintained~     in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as~     part of the historical database maintained by the department.~   "
104797|NCT01685398|"~     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.~     The characteristic natural history of this tumor is rapid growth in the first year of life~     and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early~     intervention in superficial IH may help to minimize the risk of residual aesthetic problems.~     Topical timolol, a non selective beta-blocker, is an emerging treatment which has been~     reported in efficacy and safety for the treatment of IH. However, the reported studies were~     case-series or small study. This study is a prospective double-blind,randomized-controlled~     study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in~     superficial IH. The patient will be treated with topical timolol for at least 6 months and~     instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over~     the entire lesion with a finger. Photographs of the lesion will be taken at the baseline and~     every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2~     investigators independently to determine the change in lesion size and visual analogue scale~     of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate~     solution in treatment of infantile hemangioma compared to placebo.~   "
104825|NCT01685034|"~     Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past~     decade that affects males predominantly, and in adults, is characterized by heartburn,~     dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic~     removal of foods and esophageal dilations due to remodeling causing significant impairment~     in quality of life. Treatment options are limited and often not well tolerated or effective.~     There is poor understanding of the natural history and long term prognosis. It has been~     associated with allergic sensitization; a high percentage of affected individuals having~     associated atopy and current literature demonstrates a seasonal distribution of incidence~     and severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective~     treatment for allergic rhinitis and asthma which can induce tolerance to environmental~     allergens.~      Given the efficacy of AIT and the association of aeroallergen sensitization and even~     seasonal variation of EoE symptoms, we hypothesized that AIT may be a treatment option for~     patients with EoE.~   "
104798|NCT01685385|"~     Difficulty in breathing or increased rate of breathing are common causes of admission to~     intensive care unit. This may be due to heart failure, or other causes such as infection in~     the lungs. Treating doctors usually perform Chest X-ray, ECG, and other tests to know if~     breathlessness is due to heart failure or other cause. Doctors also give medicines to treat~     heart failure, or other conditions of the lungs based on the symptoms and investigation~     results. BNP is released by heart which is not functioning well. However BNP levels are also~     high in case of severe infection.Hence there is equipoise in utility of BNP measurements~     among critically ill patients, and it is not a current standard of care. The current cost of~     this test (about 1000 rupees per measurement) is high, and hence its utility needs to be~     carefully examined before a widespread use. The investigators intend to test the hypothesize~     that that on-admission BNP measurements, help clinicians identify CHF early, which may~     modify therapeutic decisions, and improve outcomes. The current study is designed with an~     objective to determine if on-admission BNP value and availability of its test results to~     treating physicians will reduce in-hospital, and 30-day mortality and in-hospital morbidity.~   "
104799|NCT01685372|"~     The purpose of this study is to determine whether Fluzone High Dose increases the immune~     response to the influenza antigens contained in the vaccine compared to standard-dose~     Fluzone in immunocompromised children and young adults. Safety and efficacy data will also~     be collected.~   "
104800|NCT01685359|"~     The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau)~     pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®~     - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose.~     The objective of this randomized, parallel, clinical trial is to evaluate the~     pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin~     produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by~     Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count~     following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy~     subjects.~   "
104801|NCT01685346|"~     This is a pilot study to test the hypothesis that biofeedback-mediated stress management~     (BFSM) training can be used to reduce distress and enhance quality of life in patients with~     non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant~     physical symptoms, but even those who do not have physical symptoms have high levels of~     anxiety and depression.~   "
104802|NCT01685333|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of single intravenous dose. The objective of this randomized,~     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced~     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count~     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.~   "
104803|NCT01685320|"~     Forces applied on soft upper tissues by different laryngoscope blades during direct~     laryngoscopy and intubation are considered to be major stimuli to cause serious damages to~     the patients. The aim of this study is to compare the force and pressure applied to soft~     tissue in order to achieve the same glottis view comparing direct laryngoscopy and~     videolaryngoscopy in vivo.~   "
104804|NCT01685307|"~     Few is known on meat protein digestibility in humans and the impact of cooking process,~     while excessive intake of processed meat has been suggested to increase the risk of~     colorectal cancer.~      This study aims to measure in vivo in humans the real digestibility of beef meat proteins~     depending 2 cooking processes, using ileal tubes and stable isotopes.~   "
104805|NCT01685294|"~     This study will examine the effects of a first-line treatment for major depressive disorder~     (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.~   "
104806|NCT01685281|"~     study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI~     (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with~     PI-ADHD.~      subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as~     follows:~        1. week 1:1400 mg, week 2:700 mg, week 3:placebo~        2. week 1:700 mg,week 2: placebo,week 3:1400 mg~        3. week 1: placebo, week2:1400 mg, week 3 700 mg~      The study will consist of three periods: a screening period of up to one week, a 3-week~     double-blind treatment period, and a one-week safety follow-up period.~   "
104807|NCT01685268|"~     A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with~     Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with~     abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same~     doses of abiraterone and steroids they were receiving prior to study entry and will be~     randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with~     abiraterone. Once the best regimen is established in Part A, based on safety and antitumor~     activity, patients will be randomized to the selected treatment regimen and dose of AT13387~     in combination with abiraterone or AT13387 alone in Part B (Phase 2).~   "
104808|NCT01685255|"~     This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 versus~     tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission~     with first-line chemotherapy.~   "
104809|NCT01685242|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis~     in the conjunctival allergen challenge (CAC) model.~   "
104810|NCT01685229|"~     This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS)~     patients treated with balloon sinus dilation (BSD) versus continued medical management.~   "
104811|NCT01685216|"~     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme~     glucocerebrosidase (GCB). Gaucher disease has been classified into 3 clinical subtypes based~     on the presence or absence of neurological symptoms and the severity of these neurological~     symptoms. Patients with type 2 Gaucher disease present with acute neurological~     deterioration, and those with type 3 disease typically display a more sub acute neurological~     course. Type 1 Gaucher disease, the most common form accounting for more than 90% of all~     Gaucher disease cases, does not involve the central nervous system.~      The purpose of this clinical research study is to investigate the safety and effectiveness~     of velaglucerase alfa in patients with type 3 Gaucher disease.~   "
104813|NCT01685190|"~     Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed~     annually. 35% of these are locally advanced disease. These patients have a high chance of~     pelvic lymph node involvement and have relatively poor prostate cancer survival rates of~     22.5% at 10 years.~      One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL~     is a multi-centre phase II non-comparative randomised feasibility trial, in which patients~     with a high chance of pelvic lymph node involvement are randomised between prostate~     radiotherapy alone and prostate + pelvic radiotherapy.~      Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT).~     This is a relatively new method of shaping radiotherapy treatment beams which allows the~     tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy~     tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver~     higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this~     has been tested in a single hospital, single group setting and levels of side effects~     (toxicity) were acceptable.~      PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy~     remain acceptable when treatment is given in multiple cancer centres across the UK. It is~     randomised to ensure unbiased collection of acute toxicity data and to provide information~     on patients' willingness to participate in a randomised study. Should the phase II study be~     successful, the investigators would develop a phase III trial to compare treatment~     effectiveness (disease control).~      Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy~     and data relating to toxicity will be collected. They will also be asked to complete patient~     related symptoms questionnaires. Data related to disease recurrence will then be collected~     annually from patients' standard hospital visits.~   "
104814|NCT01685177|"~     Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a~     modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is~     performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up.~     Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least~     equally to standard duodenal switch as a second step after sleeve gastrectomy in the~     super-morbid patient. Secondary aims are to demonstrate that single-anastomosis~     duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid~     and long-term complications.~   "
104815|NCT01685164|"~     As intrauterine contraception is an increasingly popular form of contraception the objective~     of our study is to examine if uterine size or posture affects the insertion or use of~     intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing~     device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.~   "
104816|NCT01685151|"~     To evaluate the efficacy and safety of once a day ramelteon tablets for sublingual~     administration (TAK-375SL) in the maintenance treatment of bipolar 1 disorder.~   "
104817|NCT01685138|"~     A single-arm, open-label, two-stage multicenter, phase II study. Patients will be~     pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd will continue until~     the patient experiences unacceptable toxicity that precludes further treatment, discontinues~     treatment at the discretion of the investigator or patient, starts a new anticancer therapy~     and/or dies. LDK378 may be continued beyond RECIST defined PD as assessed by the~     investigator, if in the judgment of the investigator, there is evidence of clinical benefit.~     Patients who discontinue the study medication in the absence of progression will continue to~     be followed for tumor assessment until the time of PD as assessed by the investigator. Male~     and female patients aged 18 or over with ALK-rearranged NSCLC will be screened for~     eligibility. Patients must have received no prior crizotinib, and must be chemotherapy-naïve~     or have been pretreated with cytotoxic chemotherapy (up to three prior lines)~   "
104818|NCT01685125|"~     This phase II trial studies how well giving abiraterone acetate and prednisone with or~     without dasatinib works in treating patients with metastatic, hormone-resistant prostate~     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such~     as abiraterone acetate, may lessen the amount of androgens made by the body. Dasatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is~     not yet known whether abiraterone acetate and prednisone is more effective than abiraterone~     acetate, prednisone, and dasatinib in treating prostate cancer~   "
104819|NCT01685112|"~     Although few cases reported successful treatment of septic shock using extracorporeal~     membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment~     (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a~     randomized study to allocate patients in such critical condition, we aimed to conduct a~     retrospective observational study using propensity score matched analysis to compare the~     survival of adults with septic shock treated by ECMO or conventional treatment.~   "
104820|NCT01685099|"~     1. To investigate the difference of PE inflammation/apoptosis-associated markers between~          TB pleurisy and non-TB pleurisy~        2. To investigate the difference of neutrophil apoptosis in exudative PE between TB~          pleurisy and non-TB pleurisy~        3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB~          antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy~        4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and~          apoptosis pattern of PE neutrophil for tuberculous pleurisy~   "
104821|NCT01685086|"~     To follow-up the latent tuberculosis infection and evaluate the risk of developing active~     tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis~   "
104822|NCT01685073|"~     The number of people seeking treatment for marijuana-related problems is on the rise, yet~     there is no currently accepted medication proven to help them quit. Frequent marijuana users~     have reported that they have trouble sleeping when they try to quit, and that the loss of~     sleep can lead to relapse. This research is designed to measure the severity of sleep~     problems in people as they are trying to quit heavy use of marijuana, and to investigate~     whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to~     stop using marijuana.~   "
104823|NCT01685060|"~     A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd will~     continue until the patient experiences unacceptable toxicity that precludes further~     treatment, discontinues treatment at the discretion of the investigator or patient, starts a~     new anti-cancer therapy and/or dies. LDK378 may be continued beyond RECIST-defined PD as~     assessed by the investigator if, in the judgment of the investigator, there is evidence of~     clinical benefit. In these patients tumor assessment should continue as per the schedule of~     assessments until treatment with LDK378 is permanently discontinued. Patients who~     discontinue the study medication in the absence of progression will continue to be followed~     for tumor assessment until the time of PD as assessed by the investigator~   "
104824|NCT01685047|"~     The purpose of this investigation is to determine the prevalence of device-recorded ST~     segment changes occurring before appropriate ICD therapies (ATP or Shock) and to define~     their temporal relationship to ventricular arrhythmias.~   "
104828|NCT01684995|"~     The goal of this study is to test, in combination with the nicotine patch, the incremental~     efficacy of a motivationally tailored behavioral intervention over a minimal intervention.~     The interventions will be delivered through primary care medical clinics. The defined~     population comprises low income, less educated smokers who will vary in their level of~     motivation to quit smoking. Patients will be randomly assigned within clinics to one of two~     interventions (a) Nicotine patch prescription plus brief physician advice (minimal care);~     and (b) Nicotine patch prescription plus brief physician advice, with the addition of a~     tailored motivational intervention, a behavioral skills counseling session for smoking~     cessation.~   "
104829|NCT01684982|"~     Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in~     patient with acute myocardial infarction treated with primary percutaneous coronary~     intervention (PCI)~   "
104830|NCT01684969|"~     This will be a blinded study to compare the absorption of topical haloperidol with placebo~   "
104831|NCT01684956|"~     The investigators are doing this research study to find out if the type of needle used to~     administer them affects the speed with which insulin and glucagon get into the blood. The~     investigators will compare a traditional insulin needle to an injection device, called the~     MicronJet, that uses microneedles to deliver medication into the top layer of your skin.~   "
104832|NCT01684943|"~     The investigators are doing this research study to compare the pharmacokinetics (rate of~     absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine~     (Apidra) within individual subjects.~      Additionally, the investigators will perform a preliminary feasibility evaluation of a~     minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK~     parameters in human subjects.~   "
104833|NCT01684930|"~     The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high~     nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised~     exercise training at the limb ischemic threshold (SET) will produce a greater clinical~     benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb~     ischemic threshold (PET).~   "
104834|NCT01684917|"~     The overall objective of the research is to develop new methods for studying the link~     between diet, health and disease.~      The enquiry consists of two part. A metabolomic biomarker discovery study followed by a~     randomised controlled trial of moderate dietary induced weight loss.~      A cohort of moderately overweight men and women will undergo a metabolomic study follow by~     randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week~     period. This intervention will improve the volunteer's body composition and reduce their~     risk of developing diabetes.~      Extensive tests will be conducted before and after the dietary intervention using emerging~     technologies with current state-of-the-art methods. These tests will monitor the numerous~     physiological adaptations that have occurred on a gene, cell, organ and organismic level.~      The study will, therefore, aim for a scientific breakthrough by developing a series of novel~     biological markers that can accurately determine an individual's health status.~   "
104835|NCT01684904|"~     The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of~     a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal~     proton modality, followed by definitive surgery. In most combined-modality trials to date,~     chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.~      In designing the regimen, the investigators attempt to improve on the standard~     cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to~     the regimen. This agent has activity against advanced esophageal cancer and is also a potent~     radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in~     reduced toxicity of various combination regimens similar to that used by CROSS trial and~     allows for easier administration in the outpatient setting.4 Third, for localized esophageal~     cancer, dose distribution patterns achievable with proton beam could potentially offer~     important clinical advantages relative to those achievable with x-rays (photons).19 Based on~     this, the investigators believe that this study should be conducted with the radiation~     modality that offers the best dosimetry achievable at our institution.~   "
104836|NCT01684891|"~     This is a single-center, open label, multiple dose study to investigate the pharmacokinetics~     of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of~     [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male~     volunteers. The anticipated time of study treatment is 4 weeks.~   "
104837|NCT01684878|"~     This two-part, multicenter study will evaluate the safety, tolerability and efficacy of~     pertuzumab in combination with standard chemotherapy in women with recurrent~     platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in,~     participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized,~     double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in~     combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).~   "
104838|NCT01684865|"~     This prospective observational study will evaluate the safety and efficacy of first-line~     rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.~     Participants initiated on rituximab maintenance therapy according to the standard of care~     and in line with the current summary of product characteristics will be followed for a~     maximum of 3 years or until disease progression occurs.~   "
104839|NCT01684852|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety~     shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product~     according to the instructions for use six times daily in both eyes over a period of 28 days.~     Response to treatment is recorded at day 28.~   "
104879|NCT01684332|"~     The aim of this study is to investigate the effects of an acute intake of three different~     types of strawberry jam, differing in the carbohydrates and antioxidants content, on~     postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in~     healthy adults.~   "
105206|NCT01680081|"~     This study was designed as a prospective multicenter trial to determine the accuracy of~     combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic~     perfusion imaging in patients with suspicious coronary artery disease compared conventional~     coronary angiography and quantitative dynamic perfusion MRI as standard reference.~   "
104840|NCT01684839|"~     Neuroma excision and digital nerve reconstruction remain the best option for the treatment~     of Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional~     nonvascularized nerve grafting is the primary option to bridge the defect. The investigators~     hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital~     nerve is better than conventional methods for reconstruction of the digital nerve defect~     after painful neuroma resection.~      This study reports treatment of painful digital neuroma using a pedicled nerve flap taken~     from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the~     patients had previous nerve injuries with or without nerve repair. The mechanisms of injury~     include sharp cut, avulsion and crush. The defects were between the middle of the distal~     phalanx and the palmar digital crease.~   "
104841|NCT01684826|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality . The final~     effect on the clinical image quality is investigated in this study.~   "
104842|NCT01684813|"~     The purpose of this study is to determine if, in type 2 diabetic patients undergoing~     treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a~     loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard~     dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet~     aggregation at 24-36 hours of treatment.~   "
104843|NCT01684800|"~     The purpose of the study is to investigate the efficacy and safety of two different dose~     levels of desmopressin orally disintegrating tablets against placebo for the treatment of~     nocturia in adult women during 12 weeks treatment~   "
104844|NCT01684787|"~     In the current practice patients with normal levels of ALT were not treated. However, a~     percentage of patients will present an advanced grade of fibrosis and cirrhosis.~      Another reason to treat is the similar response to the treatment than elevated ALT patients~     published recently in mono-infected patients.~      The investigators have not data concerning the evolution and response to the treatment in~     co-infected patients with normal ALT.~      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it~     assumes a behavior similar between mono and co-infected patients and the results are~     different.~      In the case of normal ALT the investigators do not know if the natural history in~     co-infected patients is similar than the mono-infected patients, and also the response of~     the treatment.~      This study prospective and controls is the answer of this question. The main hypothesis is~     if the response of treatment in co-infected patients is not inferior than mono-infected~     patients.~      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin~     in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE~     (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning~     genotype, gender and hospital.~   "
104845|NCT01684774|"~     The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic~     landmark-guided (ALG) ankle block to determine which of these procedures is better in~     surgical anesthesia and in postoperative pain relief.~   "
104846|NCT01684761|"~     The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell~     Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis~     (SPMS).~   "
104847|NCT01684748|"~     Overweight and obesity, which afflicts ~65% of the U.S. population and more than 1 billion~     people worldwide, increases the risk of developing hypertension. Activation of the renin~     angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension.~     In addition to its vasoconstricting and sodium retaining actions, angiotensin II also has~     potent pro-inflammatory actions including macrophage infiltration and expression of~     proinflammatory cytokines in target tissues. Adipose tissue and skeletal muscle appear to be~     a key sites for the generation of proinflammatory cytokines. Although angiotensin II~     receptor blockade reduces inflammation in many tissues, the effects on adipose tissue and~     skeletal muscle in humans are not clear. Importantly, the chronic low grade inflammatory~     state that accompanies obesity complicates hypertension by contributing to insulin~     resistance and accelerating cardiovascular disease. Therefore, the general aim of the~     present proposal will be to determine the influence of angiotensin II receptor blockade on~     adipose tissue and skeletal muscle inflammation and its relation to improvements in insulin~     sensitivity, if observed, in obese hypertensive humans. To address these aims, 44 obese~     (BMI>30 kg/m2) hypertensive (BP>140 systolic and/or 90 diastolic) individuals (age=50-65~     years) will be randomized to receive 8 weeks of either the angiotensin II receptor~     antagonist, olmesartan medoxomil, or no treatment in a crossover manner. Subcutaneous~     adipose tissue and skeletal muscle biopsies will be obtained and insulin sensitivity~     (intravenous glucose tolerance tests) will be assessed at baseline and following 8 weeks of~     each intervention. A two week washout period will separate the interventions.~   "
104848|NCT01684735|"~     Evaluation of the response to chemotherapy in breast cancer patients by the use of~     Diffusion-weighted magnetic resonance imaging of the breast before the start of~     chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.~   "
104849|NCT01684722|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL with a~     history of diabetes and will examine whether vitamin D or fish oil prevents the development~     and progression of diabetic kidney disease.~   "
104850|NCT01684709|"~     This study compares the medical and psychological effects of telemonitoring plus intensified~     self-management support to those of usual care alone for patients with poorly controlled~     type 2 diabetes mellitus (DM). If this intervention proves effective without increasing~     costs or clinician burden, then its implementation could yield major public health benefits,~     especially for vulnerable and underserved DM patients, and broader societal benefit may~     occur through increased helping behavior and strengthened social ties.~   "
104851|NCT01684696|"~     Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is~     unique because of racial disparity, persistent mortality rate, and social stigma. Lung~     cancer stigma (LCS) and difficult patient-clinician communication may be an underlying~     factor in health disparities in lung cancer. The purpose of this study is to PILOT test, in~     a diverse sample of lung cancer patients the effectiveness of the mHealth Tool for Lung~     Cancer patients (mHealthTLC), an interactive, immersive 3-dimensional iPad application that~     allows individuals to experience first person virtual visits with their clinicians, to~     improve patient-clinician communication, decrease LCS, and promote optimal self-management.~     The study hypotheses are that patients who receive the mHealth TLC will improve their~     ability to communicate effectively with their clinicians and will report decreased stigma~     related to their lung cancer diagnosis compared to the attention control group.~   "
104852|NCT01684683|"~     Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease~     (COPD) and asthma. However, there is no supporting evidence for their efficacy in the~     treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in~     bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with~     theophylline in subjects with non-cystic fibrosis bronchiectasis.~   "
104853|NCT01684670|"~     This research study is designed to investigate the feasibility and treatment effects of a~     behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria.~     The speech sessions will provide an intensive, articulation-based intervention focused on~     increasing effort during speech production via use of clear speech. A single subject~     multiple baselines across subjects design will be employed in a total of six subjects~     divided into two groups of three. Changes in dependent measures will be determined by visual~     inspection, effect size determination, and time series analysis. The study follows accepted~     procedures in rehabilitation treatment and research and there are minimal foreseeable risks~     associated with participation.~   "
104854|NCT01684657|"~     The purpose of this research study is to find out the potential benefits and safety of~     asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.~      It is hypothesized that individuals who are randomly assigned to asenapine will have an~     improvement in speech as compared to a placebo.~   "
104855|NCT01684644|"~     The purpose of this study is to investigate the effectiveness of parent training in the~     treatment of ADHD in young children (ages 3-7) referred to Danish child mental health~     services. Medication is not recommended as first-line treatment for young children with~     ADHD. Parent training is recommended, but has not been formally introduced or established in~     Denmark. The study will investigate the effectiveness of a parent training programme~     specifically developed to target ADHD symptoms in young children; The New Forest Parenting~     Programme, against Treatment as Usual for children diagnosed with ADHD at two different~     child mental health clinics in Denmark.~   "
104856|NCT01684631|"~     The objective is to evaluate the implant survival rate for patients implanted with a~     PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the~     treatment of a severe hip disease and true femoral cervical fracture.~   "
104857|NCT01684618|"~     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral~          oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to~          detect induced changes in the cerebral regional saturation.~        -  The purpose of the study is to investigate our hypothesis that a particular CPAP flow~          pressure optimizes the regional cerebral oxygenation.~   "
104858|NCT01684605|"~     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after~     IV administration in health male volunteers~   "
104859|NCT01684592|"~     Smoking is a leading cause of death and other negative health outcomes. While a high~     percentage of women quit smoking during pregnancy, the majority relapse in the first 6~     months postpartum. We propose developing and pilot testing a phone-based postpartum~     continuing care (PPCC) protocol based on existing evidence-based approaches to increase~     smoking cessation, reduce relapse, increase early re-intervention, and reduce infant~     exposure to environmental tobacco smoke in the postpartum period.~   "
104860|NCT01684579|"~     Recent studies have shown that some behavioral factors such as physical activity and~     exercise may improve quality of life and outcome in patients with breast cancer as well as~     decrease body fat, increase lean mass and reduce cancer-promoting hormones. None of these~     studies have been performed in African-American women with breast cancer. The medical field~     needs to understand how exercise may benefit cancer patients, particularly African~     Americans, and how to optimize these benefits to improve the quality of life, prognosis and~     survival.~   "
104861|NCT01684566|"~     To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral~     mucositis in patients receiving conditioning treatment for hematopoietic stem cell~     transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral~     mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed~     daily by the investigator over the 28-day study period.~   "
104862|NCT01684553|"~     It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and~     lesser feelings of hunger and desire to eat and higher levels of fullness after the meal~     compared to eating the same meal more quickly.~   "
104863|NCT01684540|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition~     the effectiveness and safety shall be compared to a Sinupret forte. The patient applies~     Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use.~     The observation takes place over a period of 14 days. Response to treatment is recorded at~     day 7 and day 14 by the physician and in daily by the patient in a dairy.~   "
104864|NCT01684527|"~     The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence~     the population of lung immature myeloid cells and dendritic cells in a way that will impair~     their ability to invoke an effective immune response and lead to prolonged inflammation,~     angiogenesis and scarring. This may lead in turn to disturbed lung function.~      Our aim is to determine the presence and phenotype of immature myeloid cells present in~     respiratory secretions of children with RSV bronchiolitis as compared to non-RSV~     bronchiolitis and healthy controls.~   "
105249|NCT01679522|"~     To compare the feasibility, safety, and efficacy between single-port and four-port~     laparoscopic surgical staging in patients with early stage endometrial cancer.~   "
104865|NCT01684514|"~     Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic~     structures in vivo. The examination is carried out with a confocal laser endomicroscope,~     which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured~     by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The~     method has potential to replace conventional microscopy and the dynamic nature of the~     procedure allows visualization of structures and cellular processes in almost real-time.~     This provides us with a potentially new diagnostic tool with a promising future. To date~     only a few studies have been published on inflammatory bowel disease (IBD) and in the~     literature high-quality research is still lacking.~      The project consists of a blinded prospective observation and methodology study including~     inter- and intra-observation of patients with proctitis before and after initiation of local~     treatment.~      Hypothesis: CLE can be used to assess the degree and extend of acute and chronic~     inflammation and treatment response in patients with ulcerative colitis and is a sensitive~     supplementary to conventional diagnostics.~   "
104866|NCT01684501|"~     The purpose of this study is to perform clinical testing of the PowerFoot in a group of~     individuals with trans-tibial amputation with the objective of optimizing its performance~     and comparing it with a current state-of-art passive-elastic ankle-foot prosthesis, i.e. the~     Ceterus Flex-Foot.~   "
104867|NCT01684488|"~     The research will first examine data obtained from YRI participants to investigate effects~     of the group sessions on psychosocial and functioning outcomes in youth.~      In pursuit of this aim, this research will investigate the following hypothesis:~     Participation in the Youth Readiness Intervention will reduce symptoms of internalizing,~     externalizing, trauma-related symptoms, and improve prosocial skills and functioning among~     war-affected 15-24 year olds in Sierra Leone.~      The research also intends to examine whether youth enrolled in a psychosocial Youth~     Readiness Intervention (YRI) and a complementary education program fare better than an~     education-only control group, a psychosocial-only control group, and a waitlist control~     group.~      In pursuit of this second aim, this research will investigate the following hypothesis: A~     combined psychosocial-education program is an effective paradigm for improving psychosocial,~     functional, educational, and economic self-sufficiency outcomes among war-affected youth.~   "
104868|NCT01684475|"~     The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of~     dopamine receptors and thereby reduce symptoms of Parkinson's Disease.~   "
104869|NCT01684462|"~     In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the~     patients occurred within 12 hours of acute ischemic stroke.~   "
104870|NCT01684449|"~     The soft tissue sarcomas (STS) constitute an infrequent group of malignant neoplasms of~     mesenchymal origin. In Spain, the approximate incidence is of 2 new cases per 100.000~     inhabitants every year. In patients with metastatic STS, the average survival is very short,~     approximately 12 months. The systemic treatment of the metastatic disease has had a very~     limited development, with few satisfactory results. This facts reflect the urgent need to~     identify new active agents for treatment of these patients.~      The molecular pathway of the serine/threonine kinase mammalian target of rapamycin (mTOR)~     plays a central role in the regulation of the proteins translation, cellular growth and~     metabolism (Meric-Bernstam F et al. 2009). Currently, the mTOR pathway is considered a~     relevant target for the development of anti-cancer drugs, as rapamycin. Preliminary results~     of some clinical trials suggest that mTOR inhibitors could have some clinical activity for~     different types of sarcoma, including STS (Chawla et al Proc.ASCO 2006; Schuetze et al.~     Proc.ASCO 2006).~      Gemcitabine is a chemotherapy antimetabolite agent with a broad antitumoral spectrum. The~     activity of this drug to treat resistant sarcomas and its reduced toxicity make from~     gemcitabine an adequate candidate for its study in combination with new drugs addressed to~     molecular targets in the STS treatment.~      Pre-clinical studies suggest that mTOR inhibitors could have a potential synergistic or~     additive effect with some chemotherapy agents. The combination of rapamycin and gemcitabine~     seems to be a reasonable strategy to explore for the STS treatment.~   "
104871|NCT01684436|"~     This study will access changes in tear protein levels and symptoms of dry eye following~     insertion of a punctal plug.~   "
104872|NCT01684423|"~     The purpose of this study is to find out whether rivaroxaban is safe to use in children and~     how long it stays in the body. There will also be a check for bleeding and worsening of~     blood clots.~   "
104873|NCT01684410|"~     This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the~     safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day~     for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment~     duration in this study was intended to provide multi-dose safety information prior to~     proceeding to longer durations of exposure.~   "
104874|NCT01684397|"~     This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and~     bevacizumab and to see how well they work in treating patients with previously untreated~     kidney cancer that has spread to other places in the body (metastatic). Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking~     blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor~     growth by blocking the ability of tumor cells to grow and spread. Giving pazopanib~     hydrochloride together with bevacizumab may kill more tumor cells.~   "
104875|NCT01684384|"~     In this study the consequences of exacerbations will be visualized by high resolution~     computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung~     capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in~     HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values~     will be correlated with changes in patient reported outcomes (PROs) and lung function tests~     recorded at the same time.~   "
104876|NCT01684371|"~     The treatment of osteoarthritis, a disease that eventually affects the majority of the older~     population, involves the alleviation of symptoms such as pain and stiffness, and the~     reduction of inflammation. A double-blind, placebo-controlled, crossover study will be~     performed to examine the effect of topical application of Elmore Oil, a herbal remedy~     (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been~     reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.~   "
104880|NCT01684319|"~     Various digestive manifestations are common in infants less than 6 months and have a~     significant impact on morbidity and quality of life of the family. In a prospective study on~     more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of~     these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%),~     constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate,~     and their cause is often difficult to determine. Frequently, the pediatrician will exclude~     cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked.~     This measure causes significant additional costs through the use of extensively hydrolyzed~     milk specifically for children and involves an elimination diet of all foods containing~     cow's milk sometimes for several years. This can negatively influence the growth of the~     child.~      If the involvement of milk in these pathologies is suggested by some early studies (35% for~     colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current~     state of knowledge if these gastrointestinal symptoms are actually due to an allergy to~     milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy.~     However, various tests have proven their effectiveness in the investigation of non~     IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.~   "
104881|NCT01684306|"~     There is growing debate on the use of drugs that can promote cognitive enhancement.~     Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have~     important side effects and may induce addiction. In our study, we will investigate the use~     of modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil~     appears to have less side effects compared to amphetamine-like drugs and we will analyzed~     whether the drug can influence cognitive performances and the brain resting state network~     activity of healthy young subjects.~   "
104882|NCT01684293|"~     This study integrates a model of occupational-therapy based cognitive rehabilitation as part~     of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive~     impairment and quality of life would improve and that cocaine use would decrease in those~     participants receiving occupational-therapy based cognitive rehabilitation.~   "
104883|NCT01684280|"~     To investigate:~        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal~          adipose tissues in obese subjects.~        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between~          genders.~   "
104884|NCT01684267|"~     To test the usability and effectiveness of a robotic device, called the Robotic Gait~     Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2)~     patients with stroke with gait abnormalities secondary to impaired knee function.~   "
104885|NCT01684254|"~     The present project will focus on evaluating the technical efficacy of the in-shoe gait~     monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of~     children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.~   "
104886|NCT01684241|"~     Clinical first-in-human dose escalation study evaluating the safety and tolerability of~     intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated~     antigens in patients with advanced melanoma~   "
104887|NCT01684228|"~     End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous~     kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over~     5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems.~     The survival of these patients depends on renal replacement therapies, such as hemodialysis~     (HD), which artificially purifies the blood from toxins. The investigators assume that some~     of the uremic toxins are also present in the patient's exhaled breath, and could be detected~     by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is~     based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in~     medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by~     our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).~      In the current study, the investigators utilize this technology to identify VOCs in the~     exhaled breath of dialysis patients, and to characterize certain patterns of expression that~     could potentially help in future monitoring of HD adequacy. The investigators plan to~     collect 150 breath samples from patients before and during dialysis, and from healthy~     subjects. All participants provide a signed informed consent. Subsequently, analysis of~     samples will be done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry~     and parameters extracted from each sensor response.~   "
104888|NCT01684215|"~     This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase~     1 portion is a single-country, non-randomized, open label, clinical trial which will~     evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a~     single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination~     with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The~     Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center~     clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with~     letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+)~     HER2(-) ABC.~   "
104889|NCT01684202|"~     OPC-41061 will be administered to patients with volume overload associated with cancer,~     first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which~     urine volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic~     effects, and safety and to determine the effective initial and maintenance doses of~     OPC-41061.~   "
104890|NCT01684189|"~     Objectives：~        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile~          episodes in patients receiving chemotherapy~        2. To explore the percentage/distribution of infectious origins of febrile neutropenia~        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia~        4. To explore clinical outcomes of different infectious origins/pathogens in febrile~          neutropenia episodes~        5. To have a clear view of therapeutic actions in the management of hematological patients~          with febrile neutropenia and suspected fungal-related febrile episodes~   "
104919|NCT01683812|"~     The purpose of this descriptive study is to provide information on the feasibility of using~     the cranial cup, a new positioning device, in a small sample of prematurely born infants~     with elongated head shapes as a result of laying on their abdomens, during the convalescent~     phase of their hospitalizations.~   "
104891|NCT01684176|"~     Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk~     of a new stroke, however, poor adherence to secondary prevention medications occurs~     frequently within this patient group. The purpose of this study is to evaluate whether a~     complex tailored pharmacist intervention will lead to increased adherence to secondary~     stroke prevention medications and less new stroke events when compared to a usual care~     group. Interventions focus on motivational interviewing, medication review and telephone~     follow up.~   "
104892|NCT01684163|"~     GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major~     depressive disorder (depression) who have responded inadequately to another antidepressant~     drug during the current episode. This trial will assess the effects of GLYX-13 on depression~     when added to another antidepressant drug that the patient is already taking.~   "
104893|NCT01684150|"~     The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety~     of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary~     assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias~     bearing rearrangements of the MLL gene.~      Currently this study is in the MLL-r restricted/expansion phase and is only enrolling~     patients with rearrangements involving the MLL gene, including 11q23 or partial tandem~     duplications (PTD).~   "
104894|NCT01684137|"~     Reduction of the total IgE antibody, improved vital capacity and lung volume measured by~     spirometry.~      Improving quality of life observed in the visual analogue scale (VAS).~   "
104895|NCT01684124|"~     The investigators hypothesize that it is feasible and safe to deliver a conservative~     approach to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame~     of, on average,10 days).~   "
104896|NCT01684111|"~     To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in~     escalating doses administered with Vinorelbine i.v. in elderly patients with advanced~     Non-Small Lung Cancer (Stage IV).~   "
104897|NCT01684098|"~     The folate receptor is over-expressed on many types of cancer cells and new folate receptor~     targeted therapies are being developed to target cancer cells that over-express the folate~     receptor. As with other targeted therapies, it is important to develop diagnostic tests that~     will provide accurate information on folate receptor status and aid in selecting patients~     that may benefit from folate-targeted therapy.~   "
104898|NCT01684085|"~     This study is designed to test the effect of an explanation about the first sleep following~     trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months~     following the traumatic event.~   "
104899|NCT01684072|"~     The purpose of this study is to observe the occurrence of adverse reaction and antibody~     positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of~     live attenuated varicella vaccine without gelatin.~   "
104900|NCT01684059|"~     The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since~     the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via~     lipid peroxidation, the induction of oxidative DNA damage and the formation of protein~     adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to~     L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO~     synthases. Several studies suggest that the overproduction of this free radical and the~     subsequent excessive exposure to oxidative conditions have a potential pathogenetic~     implication, which due to the reduction of sperm motility. The present study was conducted~     to study the effect of Zn supplementation on the levels of NO synthase and arginase in semen~     of patients with asthenozoospmia.~   "
104901|NCT01684046|"~     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®~     Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand~     name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.~   "
104902|NCT01684033|"~     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®~     Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS)~     in silicone hydrogel contact lens wearers.~   "
104903|NCT01684020|"~     Rhinoplasty (nasal reconstruction i.e. a nose job) is a surgical procedure performed on~     the nose to correct a medical problem or change the appearance of the nose. During the~     healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin~     Sealant may or may not lessen these effects. This study is looking to see the effects of~     ARTISS on adhering tissue and improving wound healing in an external rhinoplasty. The~     purpose of this study is to evaluate the safety and effectiveness of rhinoplasty using~     ARTISS compared to rhinoplasty without using ARTISS in patients undergoing rhinoplasty~     performed through an external approach.~   "
104904|NCT01684007|"~     The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both~     eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant~     eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral~     implantation) at Month 3 following the second eye surgery.~   "
104905|NCT01683994|"~     Background:~      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is~     approved for medullary thyroid cancer. However, studies have shown that prostate tumors~     respond to it. Docetaxel and prednisone are standard treatments for advanced prostate~     cancer. Researchers want see if adding cabozantinib to these two drugs can be a safe and~     effective treatment for this type of cancer.~      Objectives:~      - To test the safety and effectiveness of cabozantinib with standard treatments for advanced~     prostate cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced prostate cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will receive the cancer drugs over 21-day cycles of treatment. They will~          take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will~          take about 1 hour. They will also take prednisone by mouth twice each day.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drugs for as long as their cancer does not~          worsen and side effects are not too severe.~   "
105250|NCT01679509|"~     To compare the safety and efficacy between single-port and three-port adnexal surgery in~     patients with benign ovarian and tubal disease~   "
104906|NCT01683981|"~     Due to vasodilatory properties of the NO, one of the therapeutic approaches for IPAH is oral~     use of nitric oxide precursors (10). Efficacy of L-arginine is well-documented in the~     current literature but there is paucity of data with regard to L-citrulline- malate. Hence,~     this study will evaluate therapeutic efficacy of L-citrulline- malate in two categories of~     patients with pulmonary hypertension (IPAH, and Eisenmeger syndrome). This randomized~     clinical trial utilizes 6-minute walk, pro BNP levels and the echocardiographic indexes an~     indicator of functional improvement of the patients.~   "
104907|NCT01683968|"~     This study is designed to investigate the presence and absence of abnormal heart muscle~     contractions during sickle cell crises.~      You will be asked to do echocardiography during and after your admission to the hospital. We~     will compare tow pictures and study the differences.~   "
104908|NCT01683955|"~     This study aims to assess postoperative blood loss and transfusion rates in total hip~     replacement after one-time administration of topical tranexamic acid.~   "
104909|NCT01683942|"~     Development of a novel computer software that will assist in measuring the cup/disc ratio in~     digital stereo optic disc images.~   "
104910|NCT01683929|"~     The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar~     compared to consuming artificial sweetened drink, and to evalute macronutrient consumption~     24 hours post ingestion of the drinks.~      We hypothesize that artificially sweetened (AS) consumption will lead to a relatively~     similar hormonal/metabolic responses as glucose consumption and therefore to secondary rise~     of caloric intake.~   "
104911|NCT01683916|"~     Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.~     Anesthetic requirements and stress hormone response are compared in SCI patients undergoing~     anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or~     remifentanil.~   "
104912|NCT01683903|"~     Treatment of chronic heart failure requires multidisciplinary approaches with a recognized~     role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional,~     decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of~     this disease. After recovery from the acute phase of cardiac infarction, patients admitted~     to the rehabilitation center will follow the usual rehabilitation program during the~     hospitalization period. This step precludes outpatient follow-up period in our day hospital,~     in accordance with their physicians and cardiologists who manage the monitoring. The study~     INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the~     benefits of a sustainable rehabilitation heart failure on patients treated optimally and~     educated during a follow-up period of 24 months. The main objective of the study will be to~     compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients~     for each evaluation time point, periodically recorded~   "
104913|NCT01683890|"~     To evaluate the incidence and pattern of bladder symptoms and sexual function change~     occuring after simple hysterectomy and to analyze the influence of bladder symptoms and~     sexual function change on quality of life of patients.~   "
104914|NCT01683877|"~     To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian~     function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy~   "
104915|NCT01683864|"~     The gastric carcinoma is one of the four most common tumors occurring worldwide. The~     advanced phase is characterized by metastasis and poses a very poor prognosis for survival.~     In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to~     metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis~     and its five-year survival rate is less than 2%. Even after R0 resection of a localized~     gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses~     in the form of peritoneal metastases are a common occurrence.~      Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free~     tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and~     gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which~     stands in strong contrast to the 40% risk for patients with negative cytology.~      In the study presented here (group A) therapeutic hyperthermic intraperitoneal~     chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative~     intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c~     and cisplatin will be administered following gastrectomy in patients with a gastric~     carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in~     comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also~     with free tumor cells diagnosed in cytology in the preoperative laparoscopy.~      A randomization will be performed between group A and B. Patients with gastric carcinoma~     (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved~     regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal~     lavage will be included. Exclusion criteria are extended disease or inoperable tumor.~      This study is already permitted by the local ethic commission and the German Federal~     Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code:~     HIPEC_Stomach) and was initiated in August 2012.~   "
104916|NCT01683851|"~     Hypothesis~      The use of Isolite® system does not produce upper airway obstruction in the pediatric~     population during dental treatment with conscious sedation.~      Purpose:~      Report the changes in airway patency and pediatric patient's behavior when Isolite® system~     is used for dental treatment with conscious sedation.~      Objectives:~        1. Determine changes in pulse rate~        2. Determine changes in SpO2~        3. Recognize breath sound's changes possibly associated with airway blockage~        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental~          treatment under conscious sedation~        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.~   "
104917|NCT01683838|"~     Normally, nerve fibers carry electrical impulses through the spinal cord, providing~     communication between the brain and the arms and legs. In people with spinal cord injury,~     some fibers may be destroyed at the site of injury, while others remain connected but do not~     work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal~     cord injury may have spasticity which is muscle spasms or muscle stiffness that makes~     movement difficult. Fampridine-SR is an experimental drug that increases the ability of the~     nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR~     on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such~     as bladder control, bowel function and sexual function. The study will also examine the~     possible risks of taking Fampridine-SR.~   "
104918|NCT01683825|"~     The primary aim of this pilot study is to determine whether amyloid deposits in the heart~     can be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission~     tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll~     15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a~     control group.~      The primary hypothesis of this study is that a specific amyloid binding radiotracer will~     bind to the myocardial amyloid deposits and help quantify cardiac amyloid burden.~      A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of~     the myocardium.~   "
104921|NCT01683786|"~     Purpose:~      To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment~     for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with~     undetectable HCV RNA at wk 8.~      Study Design:~      a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV~     Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50~     IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated~     interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks~     before entering this study.~   "
104922|NCT01683773|"~     This trial will investigate the administration of two new tuberculosis vaccines, called~     AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these~     vaccines are given one after the other. The trial will assess the safety of both vaccines~     and also their ability to stimulate an immune response within the body. It is hoped that~     when these two vaccines are given in sequence, the combined immune response is even better~     than when each vaccine is used individually.~   "
104923|NCT01683760|"~     The purpose of this study is to investigate the pharmacokinetics of fluconazole which is~     used as prophylaxis of invasive fungal infection in premature infants.~   "
104924|NCT01683747|"~     The premise of this study is that enteral tranexamic acid will help to maintain small bowel~     integrity, which is often compromised by critical illness due to inadequate cardiovascular~     perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease~     morbidity in critically ill patients.~   "
104925|NCT01683734|"~     The purpose of this study is to monitor the renal function of patients who have an~     antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.~   "
104926|NCT01683721|"~     The objective of the Study is to observe the use and utility of the Winx Sleep Therapy~     System in a clinical practice, for the treatment of patients with obstructive sleep apnea~     (OSA).~   "
104927|NCT01683708|"~     The aim of the present study was therefore to evaluate if the perioperative administration~     of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for~     hepato-biliary and pancreatic surgery.~   "
104928|NCT01683695|"~     This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose~     study that will enroll approximately 40 systemic lupus erythematosus subjects with active~     lupus arthritis.~   "
104929|NCT01683682|"~     To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses~     administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced~     Non-Small Lung Cancer (Stage IV).~   "
104930|NCT01683669|"~     Noisy Pressure Support Ventilation (noisy-PSV) would lead to improved lung function, while~     preserving respiratory muscle unloading. Basically, noisy PSV differs from other assisted~     mechanical ventilation modes that may also increase the variability of the respiratory~     pattern (e.g. proportional assist ventilation) by the fact that the variability does not~     depend on changes in the patient's inspiratory efforts.~      The aim of this study is to evaluate the optimal variability for noisy PSV in patients with~     ALI based on its effects on respiratory mechanics, breathing comfort, gas exchange, and~     hemodynamics. The investigators hypothesize that noise in pressure support leads to~     variations in VT that are able to improve lung function and that physiologic variables~     respond differently to the degree of variability in pressure support~   "
104931|NCT01683656|"~     HIV-infected patients are at increased risk for cardiovascular disease. Large investigations~     support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a~     treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only~     through its benefit in terms of lipid profile, but also by reducing atherosclerotic~     inflammation.~      The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients~     on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation~     associated with HIV itself in HIV-individuals on cART.~      NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to~     test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness~     (IMT) in 90 subjects.~        -  Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5~          to the end of the study (the titration aims to reduce adverse reactions)~        -  Regimen 2: ER niacin/laropiprant placebo p.m.~      The primary end point is the change in mean common carotid intima-media thickness from~     baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.~      The proposed in vivo experiments should provide insights on the potential benefits of niacin~     treatment of cardiovascular disease in HIV patients. In addition, we will be able to further~     clarify the role of systemic inflammatory mediators in the development of early~     atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment~     of non-infectious co-morbidities such as cardiovascular diseases have become essential for~     HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere~     management of opportunistic infections or virologic suppression.~   "
104932|NCT01683643|"~     The purpose of the study is to determine whether SBIRT is an effective intervention with~     inmates and to estimate the costs of providing SBIRT to this population.~   "
104933|NCT01683630|"~     This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza~     type A to type B following clinical diagnosis of influenza. Multivariate models are used to~     assess the effects of influenza type on clinical outcomes while accounting for potential~     confounders.~   "
104945|NCT01683474|"~     1. objectives~             -  Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by~               femoral artery~             -  Evaluate safety and clinical benefit of percutaneous implantation of the Venue~               MedTech aortic valve prosthesis.~             -  Continuous observe 12 months of safety and efficacy.~        2. Approximately 80 patients presenting with native aortic valve stenosis necessitating~          valve replacement which are considered unsuitable for Surgical Valve Replacement, with~          a high surgical risk, as attested to by both the surgeon and the cardiologist are~          recruited in the study.~        3. Safety and performance will be evaluated at discharge and at 30 days post procedure.~          Valve safety, performance and placement will be followed up at 6 and 12 months~          post-procedure.~   "
105251|NCT01679496|"~     The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory~     markers after intake of food items with different fatty acid composition.~   "
104934|NCT01683617|"~     Psychological stress occurs when an individual perceives that environmental demands tax or~     exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized~     as person-environment transactions, whose result is dependent on the impact of the external~     stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of~     the personal, social and cultural resources available and of the efficacy of the coping~     efforts.~      Extreme levels of stress can have a negative influence on one's professional life and can~     disrupt both the social and personal life of an individual. Stress can also cause different~     physiological and psychological disorders such as anxiety, chronic headaches, depression,~     withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.~      Stress Management Therapy can help to overcome counter effects of stress. Usually various~     techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior~     Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated~     approach covering both stress management and stress treatment is the Cognitive Behavioral~     Therapy (CBT) approach.~      The trouble with stress is that it is very personal. Thus, stress-related disorders depend a~     great deal on how the person experiencing a stressor is put together —psychologically and~     physically. So the focus for assessment, prediction and treatment has to be the person's~     situated experience.~      To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new~     paradigm for e-health - Interreality - that integrates contextualized assessment and~     treatment within a hybrid environment, bridging physical and virtual world.~      From the clinical point of view the INTERSTRESS solution may offer the following innovations~     to current traditional protocols for stress management:~        -  Objective and quantitative assessment of user's stress level using biosensors and~          behavioral analysis;~        -  Provision of warnings and motivating feedbacks to improve self awareness, compliance~          and long term outcome;~        -  Decision Support System (DSS) for treatment planning through data fusion and detection~          algorithms.~   "
104935|NCT01683604|"~     This multi-center, observational study will evaluate the treatment patterns in clinical~     practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)~     who have had an inadequate response (or were intolerant to) treatment with non-biological~     disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be~     collected from each eligible participant initiated on tocilizumab treatment by their~     treating physician according to approved label for 6 months from start of treatment.~   "
104936|NCT01683591|"~     Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to~     aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will~     evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using~     High-resolution impedance manometry (DASH). The hypothesis tested in this study is that~     high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate~     dysphagia and the diet plan in acute stroke patients.~   "
104937|NCT01683578|"~     Variable ventilation has been shown to improve lung function and reduce lung damage as well~     as inflammation in different models of the acute respiratory distress syndrome. Also,~     variable ventilation is able to recruit lungs. The present study will investigate whether~     variable as compared to non-variable ventilation improves post-operative lung function and~     reduces systemic inflammation in patients submitted to open abdominal surgery.~   "
104938|NCT01683565|"~     The purpose of this study is to examine whether supplementation with certain polyunsaturated~     fatty acids can help development and behavior of children born preterm.~   "
104939|NCT01683552|"~     Itch is a common side effect of anti-epidermal growth factor receptor antibodies and~     tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study~     evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing~     biological therapy-induced pruritus.~   "
104940|NCT01683539|"~     This study is aimed at evaluating whether the computer-based cognitive exercises in the~     Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes~     in consumers with serious mental illness and cognitive impairment enrolled in supported~     employment (SE), or whether a streamlined version of TSW without this component (the~     Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An~     RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New~     Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of~     two groups (122 each, with approximately 122 participants having schizophrenia or~     schizoaffective disorder and 122 of the participants having other diagnoses): 1) TSW, or 2)~     CSW. The TSW and CSW programs will be delivered by the same Cognitive Specialists, who will~     work as members of the SE team to integrate cognitive and vocational services. All~     participants will continue to receive SE services. Participants will be assessed at~     baseline, post-treatment at 8 months (after completion of the active teaching components of~     TSW or CSW), and at 16 and 24 months post-baseline to evaluate cognitive functioning,~     symptoms, and quality of life. All work outcomes will be tracked weekly.~   "
104941|NCT01683526|"~     The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent~     endotracheal intubation of critically-ill patients has not been well-described in the~     literature. This study will answer whether using a VL will impact on the efficacy and safety~     of intubation compared with a traditional direct laryngoscopy.~   "
104942|NCT01683513|"~     In this study the investigators compare the traditional way of triggering with a new way in~     patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper~     Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection~     (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's~     and pregnancy rate.~   "
104943|NCT01683500|"~     Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy.~     The shock wave therapy will be done in 3 sessions with one week interval. The outcome~     parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of~     painkillers.~        -  Trial with medical device~   "
104944|NCT01683487|"~     I. To investigate time measurement from emergency room admission to first antibiotic~     administration.~      II. To evaluate risk factors for prolonged time to first antibiotic administration.~      III. To correlate time measurement with Charlson comorbidity index and multimorbidity~     patterns.~      IV. To investigate the impact of a delayed time to first antibiotic administration on the~     outcome~   "
104977|NCT01683058|"~     The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development~     program and has been designed to demonstrate the efficacy and safety of aripiprazole IM~     depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects~     receive treatment during a 12-week double-blind acute treatment phase. The current trial~     (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at~     the investigator's discretion, where additional safety and tolerability data will be~     collected.~   "
105252|NCT01679483|"~     To compare the incidence of lymphocele and lymphatic ascites between patient who use versus~     who do not use FloSeal during lymph node dissection~   "
104946|NCT01683461|"~     This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women~     to examine the efficacy of an enhanced model of ongoing post-test support for women~     attending antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the~     intervention, the investigators will tailor voluntary counseling and testing (VCT) for HIV~     to the ANC setting and provide a continuum of psychosocial support for pregnant women~     through: (1) a standardized health education video before HIV pre-test counseling; (2) HIV~     pre- and post-test counseling sessions that prepare women for decisions related to testing,~     serostatus disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies~     for sexual risk behavior change; (3) two additional post-test counseling sessions postpartum~     focusing on legal education and referral, partner testing, sexual risk behavior change and~     family planning decisions and; (4) an active referral system to post-test support groups run~     by a clinically trained staff psychologist and (5) an active referral system to legal~     services run by a lawyer at the clinic.~      Through this intervention trial the investigators will be testing the following hypotheses:~      H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14~     weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV~     will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and~     Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex~     since delivery.~      H2: Women receiving the intervention will report significantly better outcomes related to~     prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months~     post-partum as compared to women in the control arm. PMTCT service uptake will be measured~     by acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,~     adherence to national infant feeding guidelines, and family planning use among HIV-positive~     women.~      H3: Women in the intervention arm will report significantly better psychosocial outcomes at~     14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial~     outcomes will be measured by: perceived social support, emotional distress, and partner~     violence among HIV-positive and HIV-negative women.~   "
104947|NCT01683448|"~     This study will be a retrospective study. The patient data from the electronic medical~     records and existing database will be collected and analyzed. Primary endpoints will be~     postoperative mortality (within 30 days) and overall complications and length of hospital~     stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,~     ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,~     infections, pulmonary complications, length of intubation time, length of ventilation time,~     and acute renal failure.~   "
104948|NCT01683435|"~     We would like to determine if HBA® testing of sperm in couples with presumed idiopathic~     infertility will reveal lower binding percentages than in couples with an identifiable cause~     of infertility either male factor or tubal factor~   "
104949|NCT01683422|"~     The current trial will provide important data on the recurrence rates and patterns of~     failure using state of the art target agent, chemotherapy and proton beam technology for~     patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or~     greater would be considered evidence of a regimen potentially worthy of further study as a~     new treatment paradigm in one arm in a future phase III trial.~   "
104950|NCT01683409|"~     This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the~     treatment of participants with mild to moderate diabetic kidney disease.~   "
104951|NCT01683396|"~     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective~     in the treatment of active inflammatory, erosive osteoarthritis of the hand.~   "
104952|NCT01683383|"~     Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability~     despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single~     most promising intervention for HIE. Reduction of brain temperature by 2° to 5°C has shown~     to be neuroprotective in newborn and adult animal models of brain ischemia. Therapeutic~     hypothermia instituted within 6 hours of birth has been shown to significantly improve~     survival and neurodevelopmental outcome in term newborns with HIE. Hypothermia is most~     effective if begun during the latent period, before the secondary energy failure. It is not~     known whether cooling initiated after 6 hours of age is effective.~      The goal of this proposal is to test the efficacy of the cooling device in achieving the~     target temperatures in patients with moderate to severe HIE during transport when compared~     with current practices.~   "
104953|NCT01683370|"~     STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values,~     emergency calls and consultations for fever, and on hospitalizations for FN in children and~     adolescents with cancer~        -  to describe the frequency of episodes of FN, and of other clinically relevant~          FN-related measures~        -  to compare these frequencies and measures in reality vs. applying Bernese standard~          limits for defining fever (ear temperature ≥39.0°C)~        -  to compare these frequencies and measures applying the Bernese standard limit of~          ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever~          (LimitLow)~        -  to determine if it would be useful to perform an interventional study on the question~          of different fever limits, powered to study both efficacy (frequency of FN) and safety~          (AE in delayed FN diagnosis)~        -  to use the platform of this prospective study to explore if the serum level of cortisol~          is associated with adverse events in FN~      HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions~     of fever from ear temperature 39.0°C to lower limits would~        -  increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).~        -  increase the rate of other clinically important FN-related measures related to~          chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related~          measures during treatment of FN episodes diagnosed in reality (secondary endpoints~          4,5,6).~        -  not relevantly decrease the proportion of FN with AE (secondary endpoint 7).~   "
104954|NCT01683357|"~     It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases~     (CLM) be left incomplete because of disease progression or technical reasons. One-stage~     hepatectomy seems a feasible and safe alternative, however, long-term results are lacking.~     This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure~     provides adequate long-term results with low risk of local recurrences.~   "
104955|NCT01683344|"~     The current study is being conducted to assess the clinical and cost effectiveness of~     managing patients with a chronic or sub-acute wound in a community setting with PICO and to~     explore the patient experience and issues of concordance that affect patients treated with~     PICO.~   "
104978|NCT01683045|"~     The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an~     effective treatment for patients with irregular heart beats who are undergoing heart~     surgery.~   "
104979|NCT01683032|"~     Creative cognition plays an important role in art, invention and innovation, as well as in~     everyday life and thus has a significant effect on society as a whole. Research with~     healthy, normal participants and those with attention deficit hyperactivity disorder~     indicates a possible inverse relationship between attentional function and creativity. This~     evidence raises the possibility that Methylphenidate (MPH; Ritalin) could decrease~     creativity in people using it for cognitive enhancement. However, this question has not been~     addressed by previous studies. Hence, the present study aims to examine the effect of MPH on~     creativity in healthy young adults.~   "
104956|NCT01683331|"~     Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in~     decreasing the incidence of NODAT among de novo kidney transplant patients with manifested~     post-transplant hyperglycemia during the first week after transplantation.~      Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress~     related to the surgery and use of higher doses of immunosuppressive medications, and leads~     to lower incidence of NODAT at 1 and 2 years.~      Specific Aim 2: To determine the improvement in overall glycemic control with the early~     initiation of insulin therapy.~      Hypothesis 2: Early initiation of insulin therapy results in greater overall control of~     glycemia compared to standard care of dietary counseling, life-style modification, oral~     hypoglycemic agents and/or insulin as needed at 1 year.~      Specific Aim 3: To determine the improvement in beta-cell function among patients assigned~     to the early initiation of insulin therapy at one year post-transplantation.~      Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of~     post-transplant hyperglycemia and preserves better beta-cell function at 1 year.~   "
104957|NCT01683318|"~     The current study aims to test the efficacy of treatment for a device that utilises a~     thermal pulsation system, which applies heat from the inner surface of the eyelids~     (Lipiflow) in patients suffering from meibomian gland dysfunction.~      Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators~     will monitor them for changes in tear film and lipid composition, as well as changes in the~     anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye~     symptoms will be documented in form of questionnaires.~      The investigators hypothesize that the treatment will be effective in improving clinical~     signs and will relieve dry eye symptoms for the patient. If this method of managing~     Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made~     available to patients in Singapore.~   "
104958|NCT01683305|"~     This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of~     cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically~     detectable tumors, and those who have detectable tumors, 2) identify all the detectable~     markers and 3) establish that biomarkers detected in NAF could also be detected in the~     biopsied tumor tissue that was removed for diagnostic purpose in subjects who have~     detectable tumors.~   "
104959|NCT01683292|"~     In this first study of inhaled apomorphine in Parkinson's disease patients, the primary~     objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing~     patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled~     apomorphine will be assessed during the study.~   "
104960|NCT01683279|"~     Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason,~     we are attempting to use a patient's own T cells, which can be genetically modified to~     expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill~     the leukemic cells though the recognition of CD19, a protein expressed on the surface of the~     majority of pediatric ALL. This is a phase I study designed to determine the maximum~     tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary~     aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic~     cells.~   "
104961|NCT01683266|"~     Primary Objective:~        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,~          regardless the injection time) in terms of change of HbA1c from baseline to endpoint~          (scheduled Month 6) in participants with type 1 diabetes mellitus~      Secondary Objective:~        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms~          of:~        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)~        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma~          glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma~          glucose (8-point profiles), glucose variability, treatment satisfaction and health~          related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)~        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target~          without hypoglycemia)~        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of~          hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)~        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody~          (AIAs) during the 12-month study period~   "
104962|NCT01683253|"~     The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved~     and neuropsychiatric traits related to ICD are changed or not when switching dopamine~     agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated~     with dopaminergic medications.~   "
104963|NCT01683240|"~     Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic~     device, which is designed to give a better flexibility to the cholangioscopy tip in order to~     enable optimal diagnostic and therapeutic precondition. Other than the conventional~     mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at~     the side of a specially developed duodenoscope (mother part) which is prepositioned distally~     to the control unit, near to the patient's mouth. Better manoeuverability of the device tip~     will lead to both a better accuracy in taking biopsies as well as a better flexibility in~     lithotripsy manoeuvres. This study is designed to test the efficiency of the device in~     relation to this assumption.~   "
104980|NCT01683019|"~     This feasibility study investigates effects of EEG-based low frequency, low emission~     magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to~     severe depressive disorder.~   "
104981|NCT01683006|"~     The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy~     rate during hypothermia after cardiac arrest.~   "
104982|NCT01682993|"~     Topography guided laser treatment enables the surgeon to correct higher order aberrations in~     corneas with irregular astigmatism. Several case reports and small uncontrolled trials have~     been published on the combination of this treatment with corneal cross linking (CCL) in~     patients with ectatic corneal diseases.~      This randomized study will evaluate the safety and efficacy of a combined treatment of~     corneal cross linking with a partial topography guided excimer laser treatment in eyes with~     progressive ectatic corneal diseases.~   "
105320|NCT01678586|"~     In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized~     clinical trial to compare the clinical effectiveness of radicular pain relief by either~     acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative~     Sensory Testing (QST).~   "
104964|NCT01683227|"~     Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive,~     integrated public health approach to identify and deliver a spectrum of early detection and~     intervention services for substance use in general medical care settings. These settings,~     such as emergency department visits, offer a potential teachable moment because patients~     may have perceptions of vulnerability about their health, and therefore be particularly~     receptive to screening and counseling. There is mounting scientific evidence suggesting~     SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of~     health care settings including primary care, emergency departments, and trauma centers.~     Although the SBIRT approach has shown promise for alcohol, relatively little is known about~     its effectiveness for adult illicit drug use specifically.~      This will be among the first studies to rigorously test the SBIRT approach for drug use. It~     will evaluate the effectiveness of SBIRT for drug use and related factors for 700~     multi-ethnic ED patients using a two-group randomized repeated-measures design in which~     biologically-validated drug use abstinence and related outcomes of an intervention group are~     compared to those of an attention-placebo control group. Over a 14-month period,~     bilingual/bicultural Health Educators recruited participants who reported past 30-day~     illicit drug use in excess of risky alcohol use from the waiting areas of two large~     hospital's ED and trauma units. Following consent procedures and standardized baseline~     assessments, Health Educators randomly assigned participants to one of the two conditions.~     The intervention group received Life Shift, an SBIRT drug use intervention matched to the~     participant's drug use risk level. The control group received the same type and quantity of~     intervention in an unrelated area—Driving and Traffic Safety (Shift Gears program), also~     matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by~     trained measurement technicians blind to the participant's assigned condition collected~     standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for~     validating self-reported abstinence. Additional outcome variables are changes in the~     frequency of drug use, functional status measures (i.e., medical problems, psychiatric~     problems, and alcohol use), and health care utilization.~   "
104965|NCT01683214|"~     The investigators are conducting this study to test the usefulness of a new type of analysis~     of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA~     allows to identify patterns of activation in brain networks and to track their changes over~     time. The investigators want to examine the possible role of brain network activation (BNA)~     in the diagnosis of mood disorders and predicting improvement over time. The procedure~     conducted with patients diagnosed with a mood disorder will be compared to people who do not~     have a mood disorder.~   "
104966|NCT01683201|"~     The aim of this research project is to evaluate the efficacy of a specific functional~     exercise programme to improve pain, stiffness and physical function in patients post total~     hip replacement from week 12 to week 18 post surgery.~   "
104967|NCT01683188|"~     This is a research study to evaluate treatment of metastatic melanoma patients with a~     combination of drugs. The combination being studied is vemurafenib (also known as Zelboraf®)~     and High Dose Interleukin-2 (abbreviated as HD IL-2 and known as Proleukin®). The~     combination of vemurafenib and HD IL-2 immunotherapy may enhance the response.~   "
104968|NCT01683175|"~     This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation~     IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor~     (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.~   "
104969|NCT01683162|"~     Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in~     preterm infants, a showed efficacy and a good clinical and biological safety profile. The~     objective of this study was to assess the effects of a new olive-oil based lipid emulsion~     compared with the traditional lipid emulsions.~   "
104970|NCT01683149|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project~     Coordinator, but will not be recruiting locally.~      The purpose of this research study is to establish a dose of the combination of drugs,~     Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The~     chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators~     are trying to find the highest dose of Topotecan and Sorafenib that can be given safely to~     children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will~     do this by testing different doses of these drugs in different groups of children. The~     investigators will also study how the body processes these drugs.~   "
104971|NCT01683136|"~     This is an open study.approximately 20 patients diagnosed with Borderline Personality~     Disorder (in case patient is under drug treatment, treatment should be stable within the~     prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS~     (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and~     will be clinically evaluated in order to monitor for improvement.~      The investigators anticipate a significant reduction in symptoms severity at the end of the~     treatment compared to study entry.~   "
104972|NCT01683123|"~     Analyze the results of conditioning with once-daily dose intravenous busulfan and~     fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid~     malignancies.~   "
104973|NCT01683110|"~     The objective of this study is to provide access to cabozantinib for eligible subjects with~     medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by~     the FDA and commercial availability of cabozantinib.~   "
104974|NCT01683097|"~     This study aims at assessing factors that affect patient choices for end of life care. 300~     patients would be assigned either to a control arm (questionnaire alone) or intervention arm~     (standardized explanation+ questionnaire). Our intervention is a standardized explanation~     which explains what code status, advance directive and end of life care mean. Based on~     patient responses, factors that affect choices of code status would be analyzed. We will~     also evaluate if a standardized explanation improves patient understanding of end of life~     issues. This would be determined by generating a composite score of correct responses to a~     subset of objective questions in the questionnaire~   "
104975|NCT01683084|"~     The purpose of this study is to determine if telmisartan is effective in slowing the~     progression of abdominal aortic aneurysms and reducing circulating concentrations of~     Abdominal Aortic Aneurysms (AAA) biomarkers.~   "
104976|NCT01683071|"~     The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome~     bupivacaine versus placebo with respect to the magnitude and duration of the analgesic~     effect achieved following single dose injection femoral nerve block with liposome~     bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three~     dose levels to be tested in Part 2.~      Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the~     analgesic effect of single injection femoral nerve block of a single dose level of liposome~     bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).~   "
105321|NCT01678573|"~     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations~     change over time) of abiraterone acetate after oral administration of abiraterone acetate at~     different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under~     fasted conditions.~   "
104983|NCT01682980|"~     The overall contribution of this study is to increase the knowledge of the efficacy of~     strength and aerobic exercise on knee related quality of life, knee pain,physical function~     and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is~     one of the most important diseases within musculoskeletal conditions affecting a~     considerable number of people worldwide. This randomized controlled trial will involve one~     intervention group delivered strength exercises compared to another intervention group~     delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared~     to a control group undergoing usual care. Cost-effectiveness analysis will be performed~     comparing the three groups. The study is funded from The Research Council of Norway.~   "
104984|NCT01682967|"~     Headache following accidental dural punction as during epidural analgesia can be severe and~     sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of~     dural puncture. Although spontaneous resolution of headaches is common in most patients~     within 7 days, in 20% can they be persistent and in some very disabling. The exact reason~     for the characteristic headache is unknown, but it is believed to be the result of leakage~     of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the~     more severe and persistent the headache. This is why larger needles (lower gauge) are known~     to have a higher incidence of PDPH. However, the type of needle also seems to play an~     important role in the likelihood of PDPH.~      Headache following accidental PDPH is very typical as it increases significantly when~     sitting or standing and often disappears completely on lying down. It is typically located~     in the back of the head, accentuated by light and often decreases with intake of large~     quantity of fluids. In many cases, it is self-limiting and most often decreases with time~     and bed rest.~      Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage,~     as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing~     that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test~     the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation~     of clinical symptoms and signs of accidental PDPH.~   "
104985|NCT01682954|"~     The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for~     diabetes prevention among employees with prediabetes.~   "
104986|NCT01682941|"~     RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer.~     Isoflavones are compounds found in soy food that may prevent cancer.~      PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in~     treating patients with recurrent prostate cancer or rising prostate-specific antigen~   "
104987|NCT01682928|"~     OBJECTIVE: To assess the efficacy of subtotal immersion therapy as an option to improve~     maternal intravascular volume thereby improving both maternal and fetal hemodynamic status~     with reversal of oligohydramnios. This will be measured utilizing the Amniotic Fluid Volume~     (AFV) as the primary outcome. Secondary outcomes will be measured using Fetal Doppler~     Studies, Maternal vital signs (Blood Pressure, Pulse Pressure, Weight, Pulse) and~     input/output.~      HYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be~     reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.~   "
104988|NCT01682915|"~     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, clinically and~     genetically heterogeneous neuropsychiatric disorder with lifelong executive dysfunctions.~     The ultimate goal of this 3-year case-control imaging genomic study with unaffected siblings~     and typically developing (TD) children as controls is to identify useful imaging~     endophenotype for ADHD by investigating the structural connectivity, as assessed by~     diffusion spectrum imaging (DSI), and functional connectivity, as assessed by resting-state~     fMRI (rsfMRI) of brain regions related to cognitive/executive controls with regards to the~     ADHD status and the presence of dopamine transporter gene variants (DAT1).~      Specific Aims:~        1. to validate the executive functions, visuospatial memory, and structural and functional~          connectivity in frontostriatal, and frontoparietal circuitries as effective~          neurocognitive endophenotypes;~        2. to correlate the data from structural and functional connectivity, neuropsychology, and~          ADHD core symptoms stratifying by the presence of ADHD, proband-unaffected sibling~          dyads, and the presence of DAT1 variant; and~        3. To investigate reported candidate genes, in addition to DAT1 variant, related to~          dopamine and noradrenergic neurotransmitter systems in the association with~          neurocognitive endophenotypes such as DRD1, DRD2, DRD4, DRD5, DBH, MAO-A, ADRA2A,~          ADRA2C, NET, and COMT.~   "
104989|NCT01682902|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects~     with type 1 diabetes.~   "
104990|NCT01682889|"~     The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on~     hemodynamic and on parameters of microcirculation in patients with peripheral arterial~     occlusive disease (PAOD).~   "
104991|NCT01682876|"~     This study was designed to conduct a comparative trial to further evaluate the safety,~     immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,~     given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2~     through 10 years of age.~   "
104992|NCT01682863|"~     This study is to assess the safety and tolerability of two different doses of QVA149 and~     QAB149 in patients with moderate to severe airflow limitation.~   "
104993|NCT01682850|"~     This study seeks to study the effectiveness of a short mindfulness based pulmonary~     rehabilitation program prior to a surgical resection in patients with lung cancer and severe~     Chronic Obstructive Lung Disease (COPD).~   "
104994|NCT01682837|"~     Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood~     pressure among patients with pre- or Stage I hypertension on their customary diet.~   "
104995|NCT01682824|"~     The goal of this research study is to learn more about eating practices of survivors of~     childhood Central Nervous System (CNS) tumors (including brain and spinal cord tumors).~      Recent research shows that childhood cancer survivors are experiencing many health issues~     months or even years after active cancer treatment (for example, irregular blood sugar~     levels, overweight/obesity, and heart disease). To address this growing concern, researchers~     at MD Anderson Children's Cancer Hospital and Texas Children's Cancer Center have joined~     forces to learn more about how to design a program that would promote healthy lifestyles~     among survivors of childhood cancer.~   "
104996|NCT01682811|"~     GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic~     therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.~      SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and~     efficacy of PDT using 5-aminolevulinic acid (ALA) and 630 nm light in the treatment of~     benign dermal neurofibromas.~      Specifically, the primary goal of the current study is to determine the maximum tolerable~     light doses that can be administered to subjects undergoing topical photoillumination~     photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical~     Solution.~   "
104997|NCT01682798|"~     The purpose of this study is to determine whether Yili Chang Qing Pro-ABB yoghurt is~     effective in improving mild constipation and the intestinal micro-ecology environment &~     alimentation.~   "
104998|NCT01682785|"~     Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive~     disorder and factors correlation.~      Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive~     disorder and factors correlation.~   "
104999|NCT01682772|"~     This is an open-label, single arm, two part adaptive design phase II trial of Olaparib in~     patients with advanced castration resistant prostate cancer.~      The trial aims to evaluate the the anti-tumour activity of Olaparib in metastatic castration~     resistant prostate cancer, identify molecular signatures of tumour cells in responding and~     non-responding patients, and to identify predictive biomarkers of Olaparib response.~   "
105000|NCT01682759|"~     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the~     sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic~     control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks,~     the mean change from baseline in hemoglobin A1C (A1C) in participants treated with~     omarigliptin is non-inferior compared with that in participants treated with glimepiride.~   "
105001|NCT01682746|"~     The goal of this proposal is to evaluate a new Photodynamic Therapy (PDT) modification which~     could revolutionize the treatment of brain tumors in children and adults. There are~     currently few cases published involving the use of PDT in infratentorial (in the posterior~     fossa) brain tumors in general and specifically those occurring in children. The~     investigators propose to test a technique, for the first time in the U.S., that demonstrated~     in Australian adult glioblastoma patients dramatic long-term, survival rates of 57%~     (anaplastic astrocytoma) and 37% (glioblastoma multiforme). These results are unprecedented~     in any other treatment protocol.~      Photodynamic therapy (PDT) is a paradigm shift in the treatment of tumors from the~     traditional resection and systemic chemotherapy methods. The principle behind photodynamic~     therapy is light-mediated activation of a photosensitizer that is selectively accumulated in~     the target tissue, causing tumor cell destruction through singlet oxygen production.~     Therefore, the photosensitizer is considered to be the first critical element in PDT~     procedures, and the activation procedure is the second step. The methodology used in this~     proposal utilizes more intensive laser light and larger Photofrin photosensitizer doses than~     prior PDT protocols in the U.S. for brain tumor patients. The PDT will consist of~     photoillumination at 630 nm beginning at the center of the tumor resection cavity, and~     delivering a total energy of 240 J cm−2. The investigators feel that the light should~     penetrate far enough into the tissue to reach migrating tumor cells, and destroy these cells~     without harming the healthy cells in which they are dispersed.~      The investigators will be testing the hypothesis that pediatric subjects with~     progressive/recurrent malignant brain tumors undergoing PDT with increased doses of~     Photofrin® and light energy than were used in our previous clinical study will show better~     progression free survival (PFS) and overall survival (OS) outcomes. PDT will also be~     effective against infratentorial tumors. The specific aims include determining the maximum~     tolerable dose (MTD) of Photofrin in children and looking for preliminary effectiveness~     trends.~   "
105002|NCT01682733|"~     The proposed study is a prospective, pilot study to assess the feasibility of a novel~     endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for~     the primary treatment of obesity. The investigators aim to recruit ten subjects with a body~     mass index between 30-40 for this study. Vertical sutures will be performed using the~     endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum~     toxin(approximately 30 units) will be injected around the sutures insertion sites in half of~     the subjects randomly to slow down muscular grinding of the stomach to see if it improves~     durability of the procedure.~   "
105003|NCT01682720|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with~     ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.~   "
105004|NCT01682707|"~     Opioids provide greater patient comfort during intubation, but are not able to abolish~     completely the release adrenergic hormones during the laryngoscopy, which may cause~     undesirable hemodynamic changes.~      In this study the investigators selected two techniques commonly used for intubation,~     laryngoscopy and track light, so the investigators can verify which intubation techniques~     provides less hemodynamic changes in coronary patients under standard anesthesia induction.~   "
105005|NCT01682694|"~     A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected~     by a reduction in serum C-reactive protein.~   "
105006|NCT01682681|"~     The purpose of this study is to evaluate the long-term retention rate of topiramate in~     participants with epilepsy (seizure disorder).~   "
105007|NCT01682668|"~     This program aims to understand the role of the subthalamic nucleus in the control of the~     movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction~     contributes to akinesia and how the STN stimulation improves motor signs in PD patients .~   "
105008|NCT01682655|"~     In the past decades, obesity in children is much more prevalent in the world. Given the~     increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.~      Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat~     content in adults.~      The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP)~     influence fatty liver in obese children and adolescent.~   "
105009|NCT01682642|"~     In this study of endometriosis patients we compare a common treatment of surgical therapy~     and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy.~     In both cases they immediately start In Vitro Fertilization (IVF) treatment.~   "
105025|NCT01682434|"~     Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate~     myopia.~      Advances over the last decade have allowed LASIK to also correct higher order wavefront~     aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided~     treatment. However, it remains to be established whether there is a beneficial effect in~     higher degrees of myopia.~      The study aims to determine whether myopic subjects (-6 to -10 diopters) with~     higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided~     treatment. Subjects are randomized to wavefront-guided treatment in one eye, and~     conventional treatment in the other.~   "
105010|NCT01682629|"~     The investigative team's purpose for conducting this research is to improve effective and~     efficient translation and implementation of evidence based advanced life support practice to~     providers of care for children. This specific project aims to accomplish 2 major goals. The~     investigators aim to evaluate the utility of a debriefing script specifically designed to~     facilitate debriefing when used by novice Pediatric Advanced Life Support instructors during~     low and high realism simulation-based learning. Secondly, the investigators hope to evaluate~     the effectiveness of high realism simulation vs. low realism simulation in achieving~     PALS-based educational outcomes, such as knowledge and skill acquisition.~      The investigators hypothesize that SCRIPTED debriefing by novice instructors following low~     and high fidelity simulation-based learning will :~        1. Improve the cognitive performance and knowledge of multidisciplinary team members as~          assessed by a cognitive performance tool and multiple choice testing compared with more~          traditional, NON-SCRIPTED debriefing;~        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team~          members as assessed by a validated assessment tool compared with more traditional,~          NON-SCRIPTED debriefing;~      The investigators hypothesize that HIGH REALISM simulation-based learning will:~        1. Improve the cognitive performance and knowledge of multidisciplinary team members as~          assessed by a cognitive performance tool and multiple choice testing compared with more~          traditional, LOW REALISM simulation;~        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team~          members as assessed by a validated assessment tool compared with more traditional, LOW~          REALISM simulation;~   "
105011|NCT01682616|"~     This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of~     ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic~     Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess~     the safety profile, to determine the maximum tolerated dose and establish the Recommended~     Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose~     escalation portion of the study will include approximately 30 subjects. Once the recommended~     phase two dose and schedule have been determined, up to 20 additional subjects will be~     enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi,~     or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs,~     as defined by iwCLL NCI/WG criteria for tumor response, subjects may re-initiate ABT-199.~   "
105012|NCT01682603|"~     To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on~     neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of~     expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of~     patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)~     patients.~   "
105013|NCT01682590|"~     The purpose of this multicentric, randomized controlled trial is to assess whether the~     timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality~     at 90 days in patients with severe acute kidney injury at the failure stage (according to~     RIFLE criteria) during the initial phase of septic shock.~   "
105014|NCT01682577|"~     The objective of this study was to find out whether the bioavailability of PT Dexa Medica's~     formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the~     innovator's product (Prexum® 4 mg, Servier).~   "
105015|NCT01682564|"~     To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on~     blood pressure in patients with hypertension diagnosed congestive heart failure~   "
105016|NCT01682551|"~     This trial is aimed to evaluate the effects of Wu Zhu Yu Tang on the prevention of Acute~     Mountain Sickness(AMS).~   "
105017|NCT01682538|"~     The study is primarily being performed in order to demonstrate bioequivalence between the~     Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also~     contain a comparison of the bioavailability of the suspension given with food and on an~     empty stomach.~   "
105018|NCT01682525|"~     To provide a novel fertility preservation option for patients facing a fertility threatening~     cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation~     program. To determine if ovarian tissue cryopreservation provides women with a useful,~     successful option for fertility preservation~      The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides~     an alternative option for fertility preservation.~   "
105019|NCT01682512|"~     The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI~     695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and~     rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based~     on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to~     Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.~   "
105020|NCT01682499|"~     This is a pilot study evaluating the feasibility of intravenous calcium and magnesium~     (Ca/Mg) infusion for prevention of taxane induced neuropathy in patients with early stage~     breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for~     4 cycles or every week for 12 weeks.~   "
105021|NCT01682486|"~     The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s~     tolerability, safety and performance and compare it to a standard un-coated Endotracheal~     tube.~   "
105022|NCT01682473|"~     To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of~     ZSTK474 in patients with advanced solid malignancies.~   "
105023|NCT01682460|"~     Research indicates that many people who are being treated for glaucoma have dry eyes. The~     purpose of this study is to test the use of artificial tears to alleviate dryness signs and~     symptoms in people who are using medication to treat glaucoma. The study hypothesis is that~     the use of artificial tears will result in an improvement in clinical signs and symptoms~     associated with dry eyes.~   "
105024|NCT01682447|"~     The purpose of this project is to investigate whether a 12-week, fulltime pulmonary~     rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life~     in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
105715|NCT01673425|"~     The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be~     effective in children but less effective in adults. Our hypothesis is that this relative~     failure is due to adults having enough anti-flu IgA antibody in nasal secretions to~     neutralize the weakened vaccine virus.~   "
105026|NCT01682421|"~     After corneal transplantation, topical corticosteroids are used to reduce the risk of~     rejection.~      However, the optimal postoperative treatment regimen is unknown. In most cases, a topical~     steroid is administered for at least 6 months after surgery, but it remains to be determined~     whether potent steroids offer better protection than weak steroids. Also, the length of the~     treatment is debated.~      Since the use of steroids is not without potential serious ocular side effects, it is of~     considerable importance to investigate these problems.~      The study aims to examine the frequency of rejection episodes after posterior lamellar~     keratoplasty; specifically comparing a short course of potent steroids versus a long course~     of weak steroids.~   "
105027|NCT01682408|"~     Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is~     Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted~     State, and to Assess the Relative Bioavailability of Process Variants of Tablets~   "
105028|NCT01682395|"~     The purpose of this study is to obtain a better understanding of the best management of~     left-sided colonic emergencies.~   "
105029|NCT01682382|"~     Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular~     measurements, will provide a blood and cheek cell sample, and will have macular pigment~     optical density (MPOD) measured to determine if there is an association between genetics,~     MPOD and the risk of progression to wet AMD.~   "
105030|NCT01682369|"~     Infants and young children do not respond as well as adults to the flu vaccines currently~     available in the UK. Fluad, is a different type of influenza vaccine that has been available~     in the European continent for the last decade, and contains an adjuvant known as MF59.~      This vaccine has been used extensively in adults over 65 years of age. It has been~     administered to over 4000 children in previous studies, which have shown that it produces an~     enhanced immune response in children compared with traditional vaccines, and that it is safe~     in this age group. It is, however, not yet licensed for use in children. The reason for this~     new study is to gain a better understanding of the how this vaccine is stimulating the~     immune system, by looking to see which parts of the genetic code are 'switched on' in~     response to immunisation, and to see how this differs from the response to currently used~     flu vaccines.~      To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive~     either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines~     currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find~     out whether it is possible to identify patterns of genetic response which can predict~     responses to immunisation. Being able to do so could potentially enable more rapid~     development of vaccines against influenza and other diseases in the future. We will also~     measure how well the immune system responds to the two vaccines and look at any side~     effects.~      The study is funded by Aditec is a collaborative research programme that aims to accelerate~     the development of novel and powerful immunisation technologies for the next generation of~     human vaccines.~   "
105031|NCT01682356|"~     The purpose of this study is to determine if nitrates in a food, in this case - beetroot~     juice (BRJ) - is efficacious in improving exercise tolerance and/or peak power in patients~     with heart failure. The investigators will also determine if BRJ improves blood pressure,~     exercise efficiency, vascular and muscle function, and whether blood levels of nitrates~     increase hourly for a total of 4 hours after BRJ ingestion. A secondary aim is to determine~     if BRJ-derived nitrates are still effective at 1, 2 and 4 weeks after starting treatment. A~     tertiary aim is to determine the variation in the 6 minute walk test. Subjects will answer a~     basic medical information sheet and undergo a 6-minute walk test. After at least a 48 hours~     rest, subjects will be asked to repeat the 6 minutes' walk. The investigators will (1)~     determine if BRJ (as compared to placebo) improves peak power output in heart failure~     patients and controls (at ~ 1½ to 2 hours after ingestion); (2) compare the changes in~     cardiac muscle (on average ~ 8-12 hours after) BRJ or placebo ingestion in patients who will~     be undergoing an left ventricle (LV) assist device placement for clinical purposes. (a~     cross-sectional study); (3) determine if BRJ decreases elevated pulmonary artery (PA)~     pressures or improves vascular and/or microvascular function (at ~ 1½ - 2 hours after~     ingestion) in patients who are already coming in for a PA catheter placement for clinical~     purposes; (4) compare the physiological changes after BRJ ingestion in non-heart failure~     control subjects with those of patients with heart failure. Endpoints measured at the same~     time points after ingestion. The investigators hypothesize (1) that patients with heart~     failure and controls will have improved exercise capacity and power at lower oxygen cost~     (and thereby greater efficiency) ~ 1½- 2 hours after ingesting beet juice (BRJ) than after~     ingesting placebo (beet juice without nitrates); (2) that patients with heart failure will~     have a greater physiologic response to BRJ than non-heart failure controls since the former~     have worse physiological function to start with; (3) that patients with high pulmonary~     artery pressures will have an improvement in the pressures after ingestion with BRJ; (4)~     that myocardial perfusion will be higher after BRJ ingestion than after placebo; (5) that~     cyclic guanosine monophosphate (cGMP) levels will be increased in left ventricle assist~     device (LVAD) samples after BRJ ingestion compared with placebo.~   "
105032|NCT01682343|"~     The purpose of this study is to investigate the appetite, insulin and incretin hormone~     responses to a high-calcium meal.~   "
105033|NCT01682330|"~     The purpose of the present study is to evaluate the long-term effects of 1 year of~     high-intensity fitness training and low-intensity whole-body vibration training on muscle~     strength and functionality. Therefore, muscle strength and functionality are measured after~     a 6-yr interval in older adults (65+).~   "
105034|NCT01682317|"~     The purpose of this study is to address the gap in knowledge regarding the relationship~     between eating frequency and weight loss.~   "
105035|NCT01682304|"~     Preliminary data from the investigator's lab identified novel patterns of differential DNA~     methylation in genes regulating cardiovascular and metabolic function in blood from women~     during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in~     the third trimester. Further, common patterns of differential DNA methylation were found in~     the common genes from placental tissue at time of birth in the same women after diagnosis~     with PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension~     may also underlie the development of chronic hypertension years after.~      It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the~     mechanism by which chronic hypertension develops in these women remote from pregnancy nor is~     it known if hypertension remote from PE is as responsive to therapeutic treatment of~     hypertension compared to women who develop hypertension without history of PE. The~     investigators plan to objectively test the central hypothesis and attain the objective of~     this project~   "
105036|NCT01682291|"~     The primary objective of this study is to compare the efficacy and tolerability of a~     life-style modifications protocol versus a protocol including life-style modifications along~     with a novel combination of dietary supplement in the management of subjects diagnosed as~     having pre-hypertension.~      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna~     (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250~     mg/day)~   "
105716|NCT01673412|"~     This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU)~     characteristics known as possible prognostic markers, and which sociodemographic and~     psychologic factors associated with VLU are associated with complete healing at 24 weeks.~   "
105037|NCT01682278|"~     The aim of this study is to evaluate if amalgam removal is associated with improved~     self-reported health, compared to no amalgam removal. The main target group consists of a~     group of patients with medically unexplained physical symptoms (MUPS), which they attribute~     to dental amalgam restorations. The patients should furthermore express the wish to have~     these amalgam fillings removed. The project is designed as a prospective cohort study,~     consisting of three groups recruited separately. The main target group will be compared with~     two comparison groups: one group of patients with MUPS recruited from general practice and~     one group of healthy study patients, recruited at dental practice. The primary research~     question is if amalgam removal is associated with improved self-reported health, compared to~     no amalgam removal, one year after completed amalgam removal.~   "
105038|NCT01682265|"~     The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency~     6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP)~     patients.~   "
105039|NCT01682252|"~     This study is being done as the doctor investigators would like to lessen the amount of~     blood transfusions given to patients. Patients who receive blood transfusions have a greater~     chance of developing complications after surgery. There is a device called the Cell Saver~     that allows the doctors to process blood that is lost during surgery and return it to the~     patient. This lessens the amount of transfused blood the patients receive. This device is~     not used for patients undergoing surgery for muscular skeletal tumors.The investigators are~     not sure whether tumor cells are present in the blood which is lost during the course of an~     operation like yours. The goal of this study is to see if we lessen the amount of blood~     transfusions given to patients who may have tumor or cancerous cells present in their blood.~     One way to do this is to test the blood that is circulating in your veins and also to test~     the blood which is lost during the course of your operation~   "
105040|NCT01682239|"~     Chronic right ventricular apical pacing has been associated with negative hemodynamic~     effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.~     An important factor seems to be optimal lead positioning. Data regarding left ventricular~     function impaired by lead positioning is insufficient. The aim of the present study~     therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal~     pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance~     imaging and clinical outcome.~   "
105041|NCT01682226|"~     The purpose of this study is to find out whether the addition of blood stem cells from a~     close family member, when added to umbilical cord blood will make the transplant safer.~   "
105042|NCT01682213|"~     In this study, the investigator's want to find out if dabrafenib can stop stage IIIC~     melanoma from coming back after surgery.~   "
105043|NCT01682200|"~     This study was conducted to determine the effects and side effects of ProOxy facial spray in~     the treatment of acne.~   "
105044|NCT01682187|"~     This is a study of oral LY2157299 as monotherapy and in combination with lomustine in~     participants with recurrent malignant glioma.~   "
105045|NCT01682174|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycaemic~     responses to a liquid meal tolerance test (LMTT).~   "
105046|NCT01682161|"~     The purpose of this study is to evaluate the change of medication satisfaction measured by~     Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are~     switched into paliperidone palmitate, either immediately or in a delayed mode.~   "
105047|NCT01682148|"~     The aim of this study is to compare Dysport treatment results after current clinical~     practice injection technique and high-concentration dilution to the neuromuscular junction~     targeted injection technique and low-concentration dilution in the elbow joint assessed by~     Modified Ashworth Scale 4 weeks post treatment. The hypothesis is that one high volume~     injection centrally located in the area/band of the NMJ zones will be as effective as the~     technique used today in current medical practice.~   "
105048|NCT01682135|"~     This trial is testing ramucirumab (LY3009806) administered to Chinese participants with~     advanced solid tumors that are resistant to standard therapy or for whom no standard therapy~     is available. The purpose of this study is to evaluate how safe ramucirumab is and whether~     it causes any side effects. The study will also measure how much ramucirumab gets into the~     blood stream and how long it takes the body to get rid of it.~   "
105049|NCT01682122|"~     Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This~     study will evaluate the frequency and persistence of wide pulse pressure in the neonatal~     population. Using a prospective study design in the Regular newborn and Observation~     nurseries of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have~     their blood pressures measured using the oscillometric method. This data will offer insight~     into whether the presence of wide pulse pressure in otherwise healthy newborn infants~     warrants further cardiovascular evaluation~   "
105050|NCT01682109|"~     Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years~     of age and at least one of their parents. Children will be included, who received~     (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children~     with primary immune deficiency or cancer.~   "
105065|NCT01681914|"~     Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this~     project seeks to assess the effectiveness of a subset of the new Mozambican clinical~     guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to~     determine response to initial and/or second-line therapy) of common signs and symptoms in~     HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in~     MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the~     new guidelines will be described; they will be compared to the previous standard of care for~     the problem(s) of interest, and the clinical importance of differences between guidelines~     designed for Mozambican non-physician clinicians and new guidelines (also issued in late~     2009) for Mozambican physicians will be described. The subset of guidelines to be addressed~     in the current phase of this 2-year project includes algorithms for diagnosis and management~     of acute fever, persistent fever, and anemia.~   "
105066|NCT01681901|"~     This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older~     patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may~     help find breast cancer and find out how far the disease has spread~   "
105051|NCT01682096|"~     The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is~     problematic when both, electrocardiogram and serum troponins are normal. Multidetector row~     computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of~     coronary artery disease.~      The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic~     strategy based on MDCT as compared to a strategy using stress echocardiography in the workup~     of patient with chest pain, normal electrocardiogram, normal troponins and suspected~     coronary artery disease. Additionally, the cost associated with both strategies will be~     compared.~      Methods. A total of 150 patients with acute chest pain coming to the emergency room with~     intermediate probability of significant coronary artery disease, normal ECG and troponins~     will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients~     showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive~     results will be admitted for further study. The primary endpoint of the study is the~     detection of an acute coronary syndrome, defined as typical or atypical angina with~     documented significant coronary artery disease (>50% stenosis) on invasive coronariography,~     a positive stress test or the occurrence of cardiac death, myocardial infarction or need for~     revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be~     evaluated by an experienced radiologist and cardiologist.~   "
105052|NCT01682083|"~     This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination~     with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical~     resection. Patients with completely resected, histologically confirmed, BRAF V600E/K~     mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc]~     cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive~     either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily~     [QD]) combination therapy or two placebos for 12 months.~   "
105053|NCT01682070|"~     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum~     pratense based on reduction of upper airways reactivity after 5 months of treatment with~     different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety~     and tolerability will be assessed by the number of related Adverse Events of different~     dosages of SUBLIVAC FIX Phleum pratense compared to placebo.~   "
105054|NCT01682057|"~     The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic~     Coupler System (ACS) in patients with severe hypertension.~   "
105055|NCT01682044|"~     This phase II trial studies the side effects and how well giving pegfilgrastim together with~     rituximab works in treating patients with untreated, relapsed, or refractory follicular~     lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL).~     Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells~     found in bone marrow or peripheral blood and may help the immune system recover from the~     side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth~     in different ways. Some block the ability of cancer to grow and spread. Others find cancer~     cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim~     together with rituximab may kill more cancer cells~   "
105056|NCT01682031|"~     This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing~     mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin~     and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients~     receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more~     effective than a placebo in reducing mucositis~   "
105057|NCT01682018|"~     The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves~     (Zephyr) would reduce native lung overinflation in patients that underwent single lung~     transplantation due to emphysema, and improve their well being and pulmonary function tests.~   "
105058|NCT01682005|"~     This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq®~     and Rotarix®) among children aged less than 5 years using insurance claims data from~     commercial plans and Medicaid low-income population. The impact of incomplete and complete~     RV vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8~     months, 8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).~   "
105059|NCT01681992|"~     The purpose of this study is to evaluate end of shelf-life potency in terms of the~     immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to~     Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).~   "
105060|NCT01681979|"~     Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the~     most commonly used classes of medicines during pregnancy. Maternal asthma and in particular~     poorly controlled asthma has been found to be associated with a number of adverse perinatal~     outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little~     is known about the safety in humans of many anti-asthma medicines when used during~     pregnancy. As a result all inhaled corticosteroids, with the exception of budesonide which~     is category B, have an FDA pregnancy category C, indicative of the fact there are no~     adequate and well controlled studies in humans.~      Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often~     in combination with the long-acting β-agonist salmeterol. Owing to small numbers of~     pregnancy exposures in the past, little is known about the safety of fluticasone propionate~     when used during pregnancy. A recent feasibility study, however, has shown that there are~     sufficient numbers of first trimester exposed pregnancies on the General Practice Research~     Database (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be~     evaluated. This study also demonstrated that using data from the GPRD it is possible to~     determine an individual's exposure to anti-asthma medicines during pregnancy and to classify~     her treatment in terms of the British Thoracic Society treatment steps based on linked~     prescription and primary care data.~      The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP)~     compared with exposure to all other inhaled corticosteroids with all major congenital~     malformations combined as the primary endpoint, whilst taking into account potential~     confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that~     exposure to fluticasone propionate during the first trimester of pregnancy is not associated~     with increased overall risk of all major congenital malformations when compared to the risk~     in those exposed to other inhaled corticosteroids during the first trimester of pregnancy.~      The study will be a retrospective cohort study and will use data from the United Kingdom's~     General Practice Research Database (GPRD). The GPRD contains longitudinal medical records~     collected within UK primary care. All medical symptoms and diagnoses are recorded in the~     database, including those relating to pregnancy, in the form of Read Codes. In addition to~     coded data GPs have the option of recording un-coded comments ('free text'), such as more~     detailed descriptions of diagnoses or treatments along with information provided to them via~     hospital letters, referrals and discharge summaries.~      As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not~     been verified, a verification exercise will be carried out. This will involve requesting and~     reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term~     births. Free text comments will be requested if they are associated with a medical code~     related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and~     other forms of communication. If the free text is not found to be informative we will send~     questionnaires to the woman's GP.~      All outcomes will be identified and verified blinded to asthma treatment and severity~     levels.~   "
105061|NCT01681966|"~     LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended~     for local infiltration into surgical wounds. The purpose of this study is to determine the~     ease of usage and administration of LNP in the surgical setting, to follow the~     Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia~     witnessed in the surgical setting.~   "
105062|NCT01681953|"~     The overall objective of this trial is to evaluate the efficacy and safety of repeated~     Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with~     alpha-Mannosidosis~   "
105063|NCT01681940|"~     The overall objective is to evaluate the long-term efficacy, safety and tolerability of~     repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis~   "
105064|NCT01681927|"~     Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually~     exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid~     retention syndrome and orthostatic edema.~      The present studies were designed to 1. Improve our ability to identify patients with~     idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg~     between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the~     history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without~     edema in idiopathic edema and autonomic failure that will identify a greater number of~     patients suffering from variable degrees of weight gain and compare to controls or other~     conditions associated with edema. The study will focus mainly on subjects with polycystic~     ovaries and autonomic failure. 3. Provide a reasonable course of therapy that is presently~     not well defined. 4. Provide evidence that orthostatic edema or weight gain has two common~     etiologies, a. an increase in vascular membrane as in idiopathic edema and b. pooling of~     blood in the lower extremities in autonomic failure due to a lack of vascular tone.~   "
105067|NCT01681888|"~     Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent~     voluntary movement. Studies have suggested that using biofeedback to increase awareness of~     muscle activation can improve motor function in patients with motor deficits. The~     investigators hypothesize that the daily use of a surface electromyographic (SEMG)~     biofeedback device for one month will improve motor function in children and young adults~     with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the~     muscle(s) the subject has difficulty in controlling and provides vibratory feedback about~     muscle activation. Groups of children and young adults (ages 3-21), with dystonia,~     hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory~     feedback device on their affected muscle(s) for 5 hours a day for one month. The device will~     vibrate and emit a blue light when the muscle is activated. At the start of the experiment,~     subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent~     Outcomes Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD).~     For one month, subjects will practice goals without device. After a month, subject will be~     assessed again and be given device to practice goals for a month. After one month, the~     subjects will be tested on the outcome measures again and return device.~   "
105068|NCT01681875|"~     Project 1, Study 1 will evaluate the relationship between nicotine yield of very low~     nicotine content cigarettes and cigarettes smoked per day, nicotine exposure,~     discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence,~     biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use,~     cigarette characteristics, cognitive function, cardiovascular function, and perceived risk.~     We will also consider differences between conditions in compliance with product use.~   "
105069|NCT01681862|"~     High blood pressure is the number one cause of death for Blacks in the United States. A~     major reason for the high rates of cardiovascular deaths is poor blood pressure control.~     Improving blood pressure control leads to large reductions in cardiovascular deaths in~     Blacks and can be achieved through interventions targeting self-management behaviors. Yet,~     despite the proven benefits of these interventions, there is little evidence of their role~     in community-based settings. In NYC, the Department of Health and Mental Hygiene (DOHMH) has~     developed Keep on Track, a volunteer-run, community program that aims to lower blood~     pressure of older adults through blood pressure monitoring sessions, brief counseling and~     health education. With support from DOHMH, lay health workers at faith-based organizations~     and senior centers take blood pressure readings for community members, record their readings~     on index cards and provide counseling to support lifestyle change and health care access.~     However, lay health workers administrating the program report difficulties managing the~     volume of tracking cards, and express interest in better tools to manage the information. To~     address this limitation, the primary aim of this study is to test the feasibility of~     implementing a Personal Health Record (PHR) system in two predominately Black churches in~     NYC to help lay health workers track changes in blood pressure and health behaviors of the~     participating congregants. The secondary aims are to evaluate the effect of the PHR system~     on changes in blood pressure, physical activity, weight loss, fruit and vegetable intake,~     and number of visits to a primary care physician from baseline to 9 months. The~     investigators hypothesize that congregants who enroll in the PHR system will have a greater~     reduction in BP; an increased intake of fruits and vegetables and levels of physical~     activity; weight loss; and report a great number of visits to their doctor at 9 months.~   "
105070|NCT01681849|"~     The purpose of this study is to assess the effects of the medication paroxetine on symptoms~     of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD~     related to childhood abuse. The hypothesis is that paroxetine will result in an improvement~     in PTSD symptoms accompanied by changes in brain functional response to reminders of~     childhood trauma.~   "
105071|NCT01681836|"~     This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will~     result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited~     toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in~     vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and~     nitrite capsules for cardiovascular disease.~   "
105072|NCT01681823|"~     To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is~     effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical~     relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side~     effects or benefits within parameter of the study is included.~   "
105073|NCT01681810|"~     This research study is being conducted to examine the effects of daily inorganic nitrite~     treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese~     adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy~     may have a major impact on the prevention and treatment of both diabetes and cardiovascular~     disease.~   "
105074|NCT01681797|"~     The purpose of this study is to determine whether fluorescence angiography is an~     effectiveness technique for the localization of vascular perforators and their area of~     perfusion and for the postoperative monitoring of flap perfusion.~   "
105075|NCT01681784|"~     To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations~     in diagnosing different urodynamic diagnoses.~   "
105076|NCT01681771|"~     The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term~     effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on~     depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in~     patients with chronic heart failure and depression.~   "
105077|NCT01681758|"~     We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in~     patients after cardiac surgery who are mechanically ventilated leads to a significant~     decrease in the amount of fluid given to such patients in the first 24 hours after surgery~   "
105078|NCT01681745|"~     This study is designed to characterize the biological response of the epidermis, dermis and~     subcutaneous tissue to treatment with the myoscience Cryo-Touch III system.~   "
105079|NCT01681732|"~     A pilot study to test the feasibility of a personalized asthma care intervention.~   "
105080|NCT01681719|"~     this study aims evaluate the ergospirometric values after 03 months of training with WBV in~     elderly health people. The hypothesis is increases of ergospirometric values.~   "
105153|NCT01680770|"~     The objective of our study is to determine the correlation of transthoracic ultrasonographic~     indices of fluid responsiveness to changes in direct measures of cardiac output and to~     compare them to other established predictors of fluid responsiveness such as central venous~     pressure variation, systolic arterial pressure variation and pulse pressure variation in a~     broad population of patients.~      Hypothesis: There will be a significant difference in the inferior vena cava respiratory~     variation and subclavian vein respiratory variation between responders and non-responders to~     intravenous fluid challenge in a broad population of patients with shock.~   "
105081|NCT01681706|"~     The purpose of this non-interventional study is to implement a survey initiative to assess~     HIV prevalence for one or more diseases and/or conditions within a specific segment of the~     population not yet diagnosed with HIV, who presents for care with the specific~     disease/condition.~      The list of diseases below is not indicative of the most important indicator diseases for~     HIV but rather a list of diseases suggested for surveillance.~      This study will enrol patients presenting with the following diseases/conditions:~        1. Presenting for care of malignant lymphoma, irrespective of type~        2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and~          above)~        3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and~          irrespective of time of diagnosis relative to time of survey),~        4. Presenting with ongoing mononucleosis-like illness~        5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks~        6. Presenting with seborrheic dermatitis / exanthema~        7. Presenting with pneumonia, admitted to hospital for at least 24h~        8. Presenting with unexplained lymphadenopathy~        9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)~       10. Presenting with primary lung cancer~       11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)~   "
105082|NCT01681693|"~     The current study is part of a large multi-investigator grant to look at the~     pharmacogenetics of a number of membrane transporters. The investigators will study~     individuals with particular genotypes of the human organic cation transporter, (hOCT3), and~     the multidrug and toxin extrusion transporter, MATE1 to test the hypothesis that genetic~     variation in hOCT3 and hMATE1 are associated with variation in the pharmacokinetics and/or~     pharmacodynamics of the antidiabetic agent, metformin.~   "
105083|NCT01681680|"~     The current study is part of a large multi-investigator grant to look at the~     pharmacogenetics of a number of membrane transporters. The investigators will study~     individuals with particular genotypes of the human organic cation transporter, (hOCT2), and~     the multidrug and toxin extrusion transporters, MATE1, MATE2-K to test the hypothesis that~     genetic variation in hOCT2, hMATEE1 and hMATE2-K are associated with variation in the~     pharmacokinetics and/or pharmacodynamics of the antidiabetic agent, metformin.~   "
105084|NCT01681667|"~     Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It~     is also known that ibuprofen levels in the blood rise higher and faster if the medication is~     taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a~     liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also~     determine whether patients with sore throat prefer to take pill or liquid form of the~     medication.~   "
105085|NCT01681654|"~     Research on physical activity and nutrition interventions aimed at positively impacting~     symptom management, treatment-related recovery and quality of life has largely excluded head~     and neck cancer populations. This translates into a lack of clinical programming available~     for these patient populations. Head and neck cancer patients deal with severe weight loss,~     with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times,~     decreased quality of life (QoL), and impaired physical functioning. To date, interventions~     to address body composition issues have focused solely on diet, despite findings that~     nutritional therapy alone is insufficient to mitigate changes. A combined physical activity~     and nutrition intervention, that also incorporates important educational components known to~     positively impact behaviour change, is warranted for this population. Pilot work suggests~     that there is large patient demand and clinic support from the health care professionals for~     a comprehensive program. Therefore, the purpose of the present study is to examine the~     impact of timing of a 12-week PA and nutrition intervention (either during or following~     treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers~     and quality of life. In addition, the investigators will examine the impact of a 12-week~     maintenance program, delivered immediately following the intervention, on adherence,~     patient-reported outcomes (i.e., management of both physical and psychosocial~     treatment-related symptoms and side-effects), as well as return to work. The investigators~     hypothesize that (1) patients who are randomized to the intervention at treatment start will~     experience improved symptom management and decreased lean body composition changes, directly~     improving recovery and QoL; (2) patients who receive a maintenance support program will have~     better long-term adherence and therefore superior treatment-related symptom management,~     physical and psychosocial functioning; and (3) return to work indices will improve and~     healthcare utilization costs will be lower in the participants who receive the immediate~     intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no~     maintenance). This research will facilitate advancements in patient wellness, survivorship,~     and autonomy, and carve the path for a physical activity and wellness education model that~     can be implemented in other cancer centers.~   "
105086|NCT01681641|"~     Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor,~     slowness in movement, rigidity and postural instability. As the disease progresses and~     treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain~     stimulation.~      When treated with deep brain stimulation, electrodes are inserted in the affected area of~     the brain and through stimulation, motor symptoms of Parkinson's disease are significantly~     reduced.~      During the first year of DBS treatment patients and spouses may experience changes in~     everyday life and illness trajectory posing new opportunities as well as new challenges.~      The purpose of the study is to develop an individualised and targeted nursing program to~     support patients and relatives manage changes and challenges in life the first three months~     after Deep Brain Stimulation. The intervention is expected to generate important knowledge~     that will serve as a foundation for the further development of a future nursing program.~   "
105087|NCT01681628|"~     Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the~     body corresponding to the meridians used in acupuncture. By using specific sequences, TFT~     can be used to treat a variety of psychological problems. Patients can be taught to treat~     themselves, and lay people can be trained to treat others in their community, as has been~     shown for narrative exposure therapy.~      Thought Field Therapy has been used to treat whole communities who have suffered~     psychological trauma following natural disasters and violent conflicts. In these~     circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other~     psychological therapies, by removing the pain of re-living the traumatic events.~      Studies in Rwanda have shown that individuals within a community can be treated with brief~     TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic~     Stress Disorder (PTSD) measurement scales have been demonstrated.~      The Kasese District has suffered from factional conflicts and the consequences of the~     ongoing struggles in neighbouring countries for many years. Although the government has~     controlled the situation and secured the borders, many are still haunted by the~     psychological consequences.~      The purpose of the study is to validate the model of addressing widespread psychological~     trauma following conflict by training community leaders to help others in their community~     using TFT.~      Thirty-six community leaders will be given a two-day training in algorithm level~     trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who~     will be assessed before and after treatment by the post-traumatic stress disorder check-list~     questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will join a~     wait-list group, who will be assessed at the same time, but treated later.~      PCL-C scores before and after treatment will be compared with the wait-list group scores~     before and after waiting, but before their treatment.~      A follow-up assessment of the participants will be undertaken 1 to 2 years later.~   "
105088|NCT01681615|"~     The investigators want to find new challenge test for Acetylsalicylic hypersensitivity /~     Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient~     as the already established protocols in terms of sensitivity and specificity.~   "
105192|NCT01680263|"~     The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs~     and physical therapy in treatment of pes anserinus tendino-bursitis.~   "
105089|NCT01681602|"~     Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only~     temporarily slow down progression.~      Exercise has the potential to improve cognition, psychological symptoms, physical~     performance and quality of life, but evidence is scarce. Previous trials are short, often~     underpowered and involving home based light exercise programs. Most have included nursing~     homes residents with severe or undefined dementia. The aim of the ADEX trial is to establish~     whether exercise is effective in improving cognition, physical performance and quality of~     life as well as reducing the prevalence of psychological symptoms among AD patients.~      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on~     power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90~     years with mild to moderate AD. The participants will be randomly allocated into two groups:~     An intervention group attending 16 weeks of continuously supervised moderate aerobic~     exercise 1 hour three times a week and a control group only receiving usual care. The~     hypothesis is that aerobic exercise will improve physical function, the cognitive and daily~     functioning and quality of life in people with mild to moderate AS.~      Blood sampling will be performed in all subjects to examine effects on biomarkers. A~     subgroup of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate~     structural changes and β-amyloid accumulation.~      Further, a health-economic analysis will be performed.~      Recruitment was started in January 2012. Last study visits are planned to be performed in~     January 2014 and results will be available in 2014. This RCT will contribute to evidence~     regarding the potential effects of a systematic program of physical exercise for patients~     with Alzheimer's disease.~   "
105090|NCT01681589|"~     The purpose of this pilot study is to investigate the relationship between attention and~     emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the~     cognitive mechanisms of emotional processing in patients with TBI, and explore novel~     treatment strategies to improve emotional regulation using with transcranial direct current~     stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.~   "
105091|NCT01681576|"~     This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and~     blood pressure in salt-sensitive Asian hypertensive patients.~   "
105092|NCT01681563|"~     This is a phase II multicenter, non-comparative, open label study in older previously~     untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the~     efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination~     with Ofatumumab (PCO).~   "
105093|NCT01681550|"~     The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1)~     analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently,~     some of these agents have been approved in combination with insulin. The potential for~     combined use with insulin has garnered increasing attention due to reduce side effects~     associated with insulin therapy and improve glycemic control. Some investigators reported~     that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of~     hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was~     short time with less than a mean of 3.0 years and the alterations of chronic diabetic~     complications by combination with incretin-based and insulin therapies are not known.~      We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1~     analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass~     index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic~     diabetic complications for 5 years-treatments.~   "
105094|NCT01681537|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational combination of drugs. Phase I studies also try to define the appropriate~     dose of the investigational combination of drugs to use for further studies.~     Investigational means that the combination of drugs is still being studied and that~     research doctors are trying to find out more about it. It also means that the FDA has not~     approved this combination of drugs for AML. As part of this research study, you will take~     lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are~     commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with~     multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered~     investigational in this research study because it is not approved by the FDA for patients~     with AML.~      Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or~     IMID. This drug is successful in the treatment of patients with multiple myeloma and some~     patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that~     lenalidomide may also be effective in patients with AML. Since we know that many patients~     who receive MEC chemotherapy alone do not have a prolonged remission (time free from~     leukemia), we are studying the addition of lenalidomide to MEC.~      In this research study, we are looking for the highest dose of lenalidomide that can be~     given safely with MEC.~   "
105095|NCT01681524|"~     The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to~     determine if the study drug in PET imaging is better than SPECT imaging currently used for~     this purpose.~   "
105096|NCT01681511|"~     The primary objective of this pilot study is to demonstrate the feasibility of recruiting~     eligible patients for the purposes of assessing the temporal aspects and rates of Catheter~     Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that~     the numbers needed for a pivotal study can be better estimated.~   "
105097|NCT01681498|"~     This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the~     feasibility of extracting fECGs in a volunteer population.~   "
105121|NCT01681186|"~     This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the~     safety and side effects of LY2940680 in healthy people. Part A will involve two groups of~     participants, each taking up to two single doses of LY2940680 at different dose levels.~     There is a minimum 14 day washout period between each of the participant's doses. The~     purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets~     into the bloodstream and how long the body takes to get rid of it. In addition, the effect~     of food and a proton pump inhibitor on LY2940680 will be studied. Part B will involve one~     group of participants who will take four single doses of 100 mg LY2940680. There is a~     minimum 7 day washout period between doses. Participants may only enroll in one part.~     Screening is required within 28 days prior to the start of the study.~   "
105098|NCT01681485|"~     Lung cancer has been the leading cancer worldwide, which can be divided into small cell lung~     cancer (SCLC) and non-small cell lung cancer (NSCLC) based on biology, therapy, and~     prognosis. NSCLC accounts for more than 85% of all lung cancer cases and has a poor~     prognosis with only 15% of all lung cancer patients alive 5 years or more after diagnosis.~      Traditional Chinese medicine (TCM) originated from Chinese philosophy is a different medical~     system from conventional western medicine. It focuses on health maintenance and emphasizes~     on harmonizing the imbalance of body. Current studies show that TCM has the advantages of~     increasing the sensitivity of chemo- and radio-therapeutics, reducing the side effects and~     chemo- and radio-therapeutics associated complications, improving patients' quality of life~     and survival time. However, how TCM can work with conventional medicine for the treatment of~     carcinoma is still an important research topic worldwide. Syndrome, the essential concept in~     TCM theory, is a diagnostic conclusion of the pathological changes at a certain stage of a~     disease, including the location, cause, and nature as well as the trend of development.~      This study aims to investigate the distribution of TCM syndromes, the changing pattern among~     NSCLC patients before and after having surgery, chemotherapy and radiation therapy, and the~     correlations with patient quality of life and progression free survival. The results are~     important for establishing guidelines for TCM practice and research in future.~   "
105099|NCT01681472|"~     The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF,~     5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in~     patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin~     (Isovorin®) respectively (60 and 200 mg/m2).~   "
105100|NCT01681459|"~     In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric~     emptying, and reduces appetite and energy intake more than an isocaloric load of~     triglyceride (TG). In obesity, the gastrointestinal sensitivity to food components may be~     reduced. In this study, the investigators compare the effects of the FFA oleic acid and the~     TG olive oil on gut hormone secretion, gastric emptying, appetite sensation, and subsequent~     energy intake in lean and severely obese subjects.~   "
105101|NCT01681446|"~     The purpose of the study is to determine whether interferon-alpha is effective in the~     treatment of low miR-26 expression patients with HCC after curative resection.~   "
105102|NCT01681433|"~     This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427~     to continuing abiraterone acetate and prednisone treatment in men with metastatic~     castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA)~     progression~   "
105103|NCT01681420|"~     Conduct a randomized controlled trial (RCT) to test the hypothesis that offering~     client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the~     risk of HIV contamination in the blood supply and also increase appropriate referrals to~     preventive and care services to persons in need in São Paulo, Brazil.~   "
105104|NCT01681407|"~     A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in~     depressive patients, treated with SSRI medications. It is an observational clinical~     bio-markers laboratory controlled research with no device.~      The research includes two groups; one for patients diagnosed of having depression, and will~     get a standard SSRI medication regimen. Second group is for control subjects without~     depression. An option for a third group is planned to include first degree relatives of the~     depressed patients. After giving their informed consents, subjects and patients will go~     through standard clinical psychiatric interview, and routine clinical lab tests. Clinical~     standard, specific depression and anxiety questionnaires will be held at four follow-up~     meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be~     asked to give blood samples at these points of time for the lab processing: Complete plasma~     proteomics and specific micro-RNA levels.~   "
105105|NCT01681394|"~     It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce~     blood pressure. However, the mechanisms implicated in these effects have not been elucidated~     yet. The purpose of this study is to evaluate changes in gene expression induced by the~     administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells~     (PBMC) in humans.~   "
105106|NCT01681381|"~     This is a prospective, multi-center, open label, randomized study to evaluate the efficacy~     and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The~     FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.~   "
105107|NCT01681368|"~     Background:~      - Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells,~     which helps to kill the cells. The drug is more likely to cause the death of cancer cells~     than normal cells because cancer cells have more of these proteins. Studies suggest that it~     can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~     Researchers want to see how well Birinapant works against the three types of cancer.~      Objectives:~      - To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube~     cancer.~      Eligibility:~      - Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube~     cancer that has not responded to standard treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. Tumor tissue samples may be collected before treatment.~          Imaging studies will also be performed.~        -  Participants will have an infusion of Birinapant once per week for 3 weeks in a row,~          followed by a break for a week on the fourth week. This 4-week schedule is one cycle of~          treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Another optional tumor biopsy will be collected 6 weeks after the start of treatment.~        -  Treatment will continue as long as the cancer does not grow and the side effects are~          not severe.~   "
105108|NCT01681355|"~     This study is initiated to investigate the gastrointestinal tolerance of a new infant~     formula in healthy, term, Asian infants.~   "
105139|NCT01680952|"~     This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) +~     Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate~     mofetil in Kidney Transplant Patients.~   "
105193|NCT01680250|"~     The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in~     reducing liver volume in autosomal dominant polycystic kidney disease.~   "
136455|NCT01268878|"~     The ending of this study is to describe the effect of febrile neutropenia on patients who~     receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).~   "
105109|NCT01681342|"~     Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment~     for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a~     combination of external beam radiation therapy and intracavitary treatment. Low dose rate~     intracavitary brachytherapy treatment is already well studied. But high dose rate~     brachytherapy is a relatively new alternative.~      In brachytherapy, major developments have been made in the integration of 3D imaging and~     computerized 3D treatment planning. Medical imaging improvements allowed for better~     definition of tumoral volumes and organs at risk.~      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of~     these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of~     volums of interest (tumor and his extensions and organs at risk : bladder, rectum,~     sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension~     in cervix cancer. However its use is not easy in many brachytherapy departments.~      This study will evaluate the feasibility and sparing of organs at risk for high dose rate~     brachytherapy if volume delineation is done at each of the two sessions performed with 3D~     RMN.~   "
105110|NCT01681329|"~     Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive~     worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD~     that has been tested in four previous clinical trials. The findings show that 60 to 70% of~     affected individuals attain GAD remission and that 50 to 55% achieve high endstate~     functioning following the treatment. Although these numbers are encouraging, there remain a~     considerable proportion of individuals who do not fully benefit from treatment. In our most~     recent CIHR-funded treatment study, we assessed the impact of information processing on the~     efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret~     ambiguous information at pre-treatment was associated with greater GAD symptoms at~     post-treatment; and b) that patients who were less successful at changing their negative~     interpretation style were also less responsive to CBT. Given that computerized~     interpretation modification training has been shown to be effective for decreasing the~     negative interpretation style of anxious individuals, the goal of the current proposal is to~     determine whether such training can augment the efficacy of CBT for adults with GAD. A total~     of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two~     conditions: a) CBT plus interpretation modification training or b) CBT plus non-active~     training. CBT will consist of 14 weekly sessions, with interpretation modification training~     (or non-active training) administered prior to each session. Measures of GAD symptoms,~     psychopathology, cognitive vulnerability, and interpretation style will be administered at~     pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study~     will provide information about the efficacy, clinical usefulness, and mechanisms of~     interpretation modification training in combination with CBT.~   "
105111|NCT01681316|"~     The purpose of this study is to evaluate the effect of Danhong Injection on the relief of~     angina with the use of the Seattle Angina Questionnaire among patients with stable angina~     patients~   "
105112|NCT01681303|"~     Recent research work has directed especial attention toward a distinct group of uremic~     retension molecules, called protein-bound uremic toxins. The prototypes of this group of~     uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production~     of free radical and impair antioxidant system and exerts direct toxicity on different cells~     and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of~     these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis~     of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic~     patients. In hemodialysis, high serum p-cresol level is associated with higher~     cardiovascular mortality.~      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It~     has superior adsorption ability for certain small-molecular weight organic compounds known~     to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of~     AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it~     was reported that AST-120 suppressed the increase in serum creatinine levels, prevented~     proteinuria, improved uremic symptoms, and, consequently, led to the postponement of~     dialysis therapy.~      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized~     AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the~     morbidity- mortality of CKD patients.~      The principal aim of this prospective cohort study is to investigate the effectiveness of~     AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of~     this relationship can help to establish new therapeutic strategy in the treatment of~     late-stage CKD patients.~   "
105113|NCT01681290|"~     The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated~     synthetic human C-peptide) following weekly subcutaneous administration for 12 months in~     type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral~     neuropathy (DPN).~   "
105114|NCT01681277|"~     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics~     of multiple rising doses of BI 113608 in healthy male volunteers~   "
105115|NCT01681264|"~     Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.~   "
105116|NCT01681251|"~     The management and delivery of intravenous fluids during surgical operations is one of the~     important duties for anesthesiologists.~      The goal of this study was to determine if goal directed fluid therapy, titrated using the~     FloTrac monitor's measurement of stroke volume variation results in a decrease in the length~     of stay of patients undergoing open abdominal aneurysm repair.~   "
105117|NCT01681238|"~     There is growing evidence that the risk of postoperative complications can be decreased by~     optimizing the amount and type of infusion fluids given during surgery, steered by~     goal-directed therapy based on flow-related hemodynamic parameters, particularly in~     high-risk patients. This study is undertaken subsequently to test the hypothesis that the~     intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive~     monitor, can partially prevented postoperative complications and shorten hospital stay in~     the elderly high-risk patients undergoing total hip replacement with continuous spinal~     anaesthesia .~   "
105118|NCT01681225|"~     This phase II multi-centered, randomized controlled trial of mechanical ventilation directed~     by esophageal pressure measurement will test the primary hypothesis that using a strategy of~     maintaining a minimal but positive transpulmonary pressure (PTP = airway pressure minus~     pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient~     survival.~   "
105119|NCT01681212|"~     The purpose of this study is to determine the survival rate after 1 year of treatment with~     ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable)~     or Stage IV melanoma.~   "
105120|NCT01681199|"~     The study is designed to assess the effect of statin on atherosclesrosis progression as well~     as to explore its potential mechanism besides lipid modifying , such as effect on~     inflammation and vascular calcification.~   "
105122|NCT01681173|"~     High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes~     and cardiovascular events in prospective observation studies. Our primary objective is to~     compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble~     fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals~     with impaired glucose tolerance. Subjects with IGT not willing to participate in the~     intervention will be used as independent controls. Secondary aims are to identify mechanisms~     of action with regard to body composition, anti-inflammatory and metabolic effects of~     fibers. We propose a randomized, prospective intervention study. The results will be of~     general relevance for guidance of fiber intake in the population and will help the food~     industry to design healthy high fiber foods. Fiber can be added at low cost to numerous~     foods. Increased fiber intake may therefore provide a simple non-cognitive prevention~     strategy effective at the population level.~   "
105123|NCT01681160|"~     This study was a Kind of clinical trial with equal randomization, that have been done from~     January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128~     diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is~     one of the more important aims for health professional specially for nurses.One of this new~     treatment is maggot therapy.~   "
105124|NCT01681147|"~     The purpose of this study is to find out whether women who have had gestational diabetes~     will make healthier lifestyle choices, achieve weight goals, and complete postpartum care~     assessments after receiving two online classes on healthy nutrition and exercise classes at~     6 weeks - 3 months and at 9 months postpartum.~   "
105125|NCT01681134|"~     The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects~     (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.~   "
105126|NCT01681121|"~     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in~     the treatment of excessive daytime sleepiness in adults with narcolepsy.~   "
105127|NCT01681108|"~     The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for~     children and adolescents to lose weight and promote their self esteem in a fun atmosphere.~   "
105128|NCT01681095|"~     The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold~     cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic~     arrest.~   "
105129|NCT01681082|"~     The general purpose of this study is to examine the effect of tai chi training on cognitive~     function in young adults. The investigators will test subjects enrolled in a semester-long~     tai chi course along with control subjects. The specific aims are to measure duration of~     practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder~     (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,~     subjects in the tai chi course will show improvements in (1a) spatial working memory and~     (1b) response inhibition. The investigators secondary hypotheses are that, among the~     subjects participating in the tai chi course, these cognitive improvements will correlate~     with (2a) improvements in balance and (2b) duration of tai chi practice, and that, among all~     participants, (2c) ADHD indications will correlate with cognitive measures.~   "
105130|NCT01681069|"~     Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the~     subjects' body weight, body fat and safety parameters are monitored~   "
105131|NCT01681056|"~     The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality~     of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is~     quality of life.~      The hypothesis of this study is that autosuggestion will increase geriatric patient's~     quality of life based on its impact to psycho-neuro-endocrine-immune pathways.~   "
105132|NCT01681043|"~     Sleep investigation in respirator treated ICU patients: the importance of intensive~     environment.~      Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay~     and increased mortality.~      The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise,~     light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep~     quality in respirator treated ICU patients.~      Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc.~     AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary~     circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m.~     after randomization.~   "
105133|NCT01681030|"~     This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of~     EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture~     line bleeding in cardiovascular surgery.~   "
105134|NCT01681017|"~     The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality~     (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth~     attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn~     Care (ENC) curricula. These facilities are located within clusters in the Global Network for~     Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret,~     Kenya.~   "
105135|NCT01681004|"~     The purpose of this study is to compare outcomes when patients with degenerative~     sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation~     or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant~     System or undergo specific, targeted non-surgical treatment of the SI joint.~   "
105136|NCT01680991|"~     This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and~     safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)~     malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated~     time on study treatment is 24 weeks.~   "
105137|NCT01680978|"~     A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to~     assess the effect of aleglitazar on cardiac energetics and function in patients with~     uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are~     drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg~     aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients~     will cross over to the treatment not yet received.~   "
105138|NCT01680965|"~     To study the safety and side effects of Ofatumumab in the treatment of chronic~     graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab~     when added to standard steroid treatment for chronic graft-versus-host disease~   "
105140|NCT01680939|"~     Every year thousands of young children with obstructive sleep apnea undergo surgery which~     requires them to be prescribed pain medication. The current standard in North America is~     administration of opioids, mainly codeine or morphine; however in many areas of the world~     including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used.~     Some North American surgeons are uncertain regarding the potential of ibuprofen to increase~     bleeding following surgery. The results of research studies have been inconclusive overall.~     Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been~     removed from the formulary at many Pediatric institutions. Some surgeons have begun to use~     oral morphine as an alternate to codeine, which necessitates the need to find safe~     alternative analgesics in this treatment group.~      The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine~     and ibuprofen in children with sleep apnea.~      An interim analysis will be conducted after recruitment of 70 patients, to monitor both~     safety and efficacy~   "
105141|NCT01680926|"~     Overweight patients with type 2 diabetes are often being treated with an intensified insulin~     therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not~     achieve satisfying metabolic control. A new therapy option is necessary that makes it~     possible to lower the daily insulin requirement and to improve metabolic control. The aim of~     this study was to investigate whether a protein-rich meal replacement is suitable to lower~     the daily insulin requirement and to reduce HbA1c and body weight.~   "
105142|NCT01680913|"~     Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In~     obese patients, the commonly used landmarks may be difficult or even impossible to feel. In~     addition, the spine can be hidden beneath a layer of fatty tissue.~      Ultrasound is useful for finding the correct injection site in pregnant patients, but the~     usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The~     potential benefits for obese patients from the use of ultrasound include shortening the~     duration of the procedure, increasing patient comfort, decreasing the total number of~     attempts, and aiding in the choice of appropriate needle length for the patient.~      The investigators hypothesize that there is no difference in time to perform a spinal~     anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients~     with BMI > 35.~   "
105143|NCT01680900|"~     This is a pilot study to determine proof in principle that vilazodone, a selective serotonin~     reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot~     flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related~     quality of life.~   "
105144|NCT01680887|"~     This is a double-blind placebo-controlled clinical trial (n = 200) of varenicline for the~     treatment of cocaine dependence that utilizes contingency management to promote treatment~     attendance.~   "
105145|NCT01680874|"~     The purpose of this study is to determine whether a probiotic, when used together with~     standard treatment, is effective in reducing duration of symptoms and preventing recurrence~     of infection in older adults with a first episode of C. difficile infection.~   "
105146|NCT01680861|"~     A recent therapeutic strategy following renal transplantation includes simultaneous use of~     reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic,~     antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with~     the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and~     chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to~     more favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal~     has also been used in the attempt to avoid well-known side effects while maintaining~     favorable patient and graft survival.8-10 While the investigators center and numerous other~     centers have also included single agent, antibody induction utilizing the lymphodepleting~     polyclonal antibody rabbit anti-human thymocyte globulin (ATG), nondepleting human~     anti-interleukin-2 receptor (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or~     lymphodepleting humanized anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now~     suggests that an even more effective induction strategy may include the combined use of more~     than one induction agent (each with fewer doses than if used alone), with the goal of~     bringing the kidney transplant recipient even closer (through more effectively timed~     lymphodepletion) to an optimally immunosuppressed state, allowing further reduction in~     long-term maintenance drug dosing.18-25 The investigators have now successfully used dual~     ATG/Dac induction therapy in both kidney-alone23-24 and simultaneous kidney-pancreas (SPK)~     transplantation,18-20 and a recent report from the investigators center of kidney-alone and~     SPK recipients shows that the addition of anti-CD25 to ATG for induction therapy more~     effectively delays the return of peripheral blood CD25+ cells.25 In the kidney-alone~     recipient study 3 doses of ATG were combined with 2 doses of Dac for induction,23-24 vs. the~     investigators previous studies utilizing single agent induction with 7 doses of ATG or 5~     doses of Dac.4,16,17 Successful combination of ATG/basiliximab as dual induction in kidney~     transplantation has also been reported elsewhere,21-22 along with equivalency in clinical~     outcomes using daclizumab vs. basiliximab.13~   "
105147|NCT01680848|"~     The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for~     diagnosis, treatment, and prevention of dental caries.~   "
105148|NCT01680835|"~     This post-approval study is designed to confirm the long-term safety and effectiveness of~     the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial~     femoral artery (SFA) and proximal popliteal arteries.~   "
105149|NCT01680822|"~     Little is known about the disease caused by the nontuberculous or environmental mycobacteria~     (NTM) and only limited data are available showing treatment outcome. This project will study~     the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois~     Hospital & Health Sciences System (UIMC). The aim of study is finding treatment outcome and~     risk factors that are associated with treatment failure in NTM patients. This is a~     retrospective, observational study for collecting data on patients with NTM in UIMC. The~     study initially involves populating the study of NTM patients seen at UIMC during the study~     period. This will add our knowledge about current treatment outcome of patients with NTM~     diseases and will be of interest to physicians, and public health authorities.~   "
105150|NCT01680809|"~     This study seeks to determine if compliance with compression therapy is increased in~     patients with healed venous insufficiency ulcerations when lower levels of compression~     therapy are prescribed. This study will measure compliance with compression therapy at low~     levels of compression. It will also seek to determine if compression therapy aids in the~     prevention of venous insufficiency ulcer recurrence.~   "
105151|NCT01680796|"~     This is an open-label phase I study in which dovitinib is given in combination with~     bortezomib and dexamethasone. Dovitinib dose escalation is planned in order to determine its~     maximum tolerated dose when given in this combination.~   "
105152|NCT01680783|"~     The objective of our study is to evaluate the efficacy of helmet ventilation as compared~     with Face mask in patients with respiratory failure.~   "
130971|NCT01341119|"~     To study clinical features, prognostic factors and treatment outcome and to develop a~     possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.~   "
105154|NCT01680757|"~     This study is a prospective, multicenter, non‐randomized trial of a stand‐alone procedure~     for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic~     events who are contraindicated for or intolerant of oral anticoagulation therapy. This study~     will enroll 100 participant, who will receive the LAA ligation study treatment. The~     objective of this registry is to assess the effectiveness of permanent exclusion of the LAA~     using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated~     with standard anticoagulation therapy. The results of the study will be used to assess~     outcomes within the first year, post‐treatment.~   "
105155|NCT01680744|"~     To protect kidney function during the transplantation process by inducing mild hypothermia~     in the deceased organ donor before organs are recovered~   "
105156|NCT01680731|"~     The purpose of this study is to investigate of the differences in pelvic floor anatomy and~     function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a~     forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women~     within 1-5 years after first delivery who did not have an internal delivery will be~     included. The total number of subjects is forty. This will include ten primiparous subjects~     who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had~     spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.~   "
105157|NCT01680718|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, we are still learning about the complex biological processes~     that contribute to positive social interactions and the ability to develop and maintain~     social relationships. Recent research has begun to focus on oxytocin and vasopressin,~     neuropeptides that are naturally produced in the hypothalamus, because administration of~     these neuropeptides has been associated with increased trust, generosity, empathy,~     cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions~     associated with social and emotional processes. To date, several aspects of oxytocin and~     vasopressin's effects on social behavior have been unexplored. As such, the overarching goal~     of this project is to examine the effects of intranasal oxytocin and vasopressin on social~     working memory, deception detection, sensitivity to interpersonal distance, empathy, and~     altruistic behavior. Understanding how oxytocin and vasopressin influence these aspects of~     social functioning will help to inform research that has begun to establish the potential~     for use of these neuropeptides in psychiatric disorders such as autism spectrum disorders~     and schizophrenia that are characterized by social deficits. For this study, we will recruit~     150 healthy adults without a history of medical or psychiatric illness to come to the~     laboratory. In the first session, participants will complete several questionnaires. In the~     second session, participants will be randomly assigned to receive oxytocin, vasopressin, or~     placebo. The study nurses will measure temperature, heart rate, and blood pressure (female~     participants will also be asked to undergo a pregnancy test) before drug administration.~     Participants will then complete computer tasks. During the second session, we will also~     collect a saliva sample for genetic analysis and participants will be asked to complete~     several additional questionnaires. At the end of the experimental session, participants will~     be fully debriefed.~      The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will~     improve social working memory and deception detection, and increase empathy and altruism. It~     is also hypothesized that main effects will not be found for oxytocin or vasopressin, but~     rather, analyses of relevant moderators will elucidate these findings.~   "
105158|NCT01680705|"~     The aim of this study is to determine what the ideal frequency of high-volume sinonasal~     saline irrigation in the early postoperative period following ESS for medically refractory~     CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline~     irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations~     for the first week is ideal with no difference between frequencies after 1 week.~   "
105159|NCT01680692|"~     The purpose of this study is to evaluate whether a new regional anesthesia technique would~     provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot~     drop after knee replacement surgery.~   "
105160|NCT01680679|"~     Influenza viruses are significant causes of human illness and death in developed and~     developing countries. This study will measure the ability of influenza vaccine given to~     children in India to protect both the children and unimmunized persons around them from~     influenza. It will also determine whether the best time to immunize in a country like India~     that has both summer and winter outbreaks of influenza is in the fall, as is done now, or~     whether immunization should be in the spring to protect against influenza infections in the~     summer.~   "
105161|NCT01680666|"~     The investigators hypothesized that, in children undergoing venous cannulation for central~     line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in~     successful venous cannulation at first attempt compared to landmark guided cannulation.~   "
105162|NCT01680653|"~     The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced~     thanks to overnight blood glucose level testing. The timing of the overnight blood test is~     often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic~     events at camp are occurring. It is also unclear what the most appropriate treatment for~     nocturnal hypoglycemia is: simple carbohydrates, or mini-glucagon.~      In this study, we will use Continuous Glucose Monitors that will send subject data securely~     to a remote computer located in the medical cottage at camp throughout the night. Study~     staff will monitor the computer and will intervene on low blood sugar as it occurs in real~     time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and on~     the rest, they will receive standard carbohydrate treatment.~   "
105163|NCT01680640|"~     Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the~     liver not caused by alcohol. The liver is an organ that is not designed to build up fat.~     NAFLD is common in people who have too much body fat in their abdomen or who have diabetes~     (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in~     thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over~     time. NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who~     already have diabetes, NAFLD can cause glucose (sugar) levels to be too high.~      Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This~     balance of healthy and harmful bugs is essential for the normal workings of our intestine to~     digest food. Providing these bacteria do not leak out into the blood they do not cause harm.~     If the balance of healthy to harmful bugs is upset, the harmful can cause problems and leak~     out into the blood. Because the liver is connected to the intestine by blood vessels the~     harmful bacteria can get to the liver and cause problems. These bacteria can cause the liver~     and the body to build up too much fat and might cause NAFLD and obesity. In this study, we~     will test the effects of a supplement (synbiotic) taken during the day, that contains a~     mixture of 'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken~     down and absorbed into the blood. We will test whether the synbiotic supplement has~     beneficial effects on the NAFLD liver condition and on factors linked to too much body fat,~     diabetes and heart disease.~   "
105164|NCT01680627|"~     The purpose of this research is to examine the effectiveness of the Computerized Alcohol~     Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department~     at the UC Irvine Medical Center. This research study will evaluate the effectiveness of the~     brief intervention compared to standard of care (no intervention). Brief interventions have~     a high potential impact in ED. Computerized alcohol screening and brief intervention (CASI)~     is a fast and easy to use tool for patients and healthcare providers. CASI provides the~     Alcohol Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and~     CRAFFT3, followed by a brief intervention and customized alcohol intake recommendations for~     the patient. This study will also determine the effectiveness of the brief intervention in~     reducing alcohol use/abuse in adolescents between 12-17 years of age.~      The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and~     provide an intervention at an early stage. The current data to support alcohol and screening~     and brief intervention in adolescents is limited. The researchers hope that this research~     study will add to the overall body of knowledge in support of using the emergency department~     as a tool in public health, as it relates to the individual patients morbidity and mortality~     (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor~     vehicle collisions).~   "
105165|NCT01680614|"~     The purpose of this research is to examine the effectiveness of computerized alcohol~     screening and brief intervention in the UC Irvine Medical Center Emergency Department (ED)~     and Trauma Patients. Brief interventions have a high potential impact in ED and Trauma~     populations. Computerized alcohol screening and brief intervention (CASI) is a fast and easy~     to use tool for patients and healthcare providers. CASI mitigates barriers to proper~     screening and intervention, including time, availability of trained personnel, patient~     comfort, and language barriers. CASI provides the Alcohol Use Disorders Identification Test~     (AUDIT) followed by a brief intervention and customized alcohol intake recomendations for~     the patient.~      The intervention of this study will be the addition of a brief CASI questionnaire to the~     standard of care for a random subset of subjects. All subjects who screen positive for~     hazardous alcohol use will be followed up and reassessed for alcohol use. The researchers~     hypothesize that the addition of CASI will lead to a decrease in alcohol intake within three~     months. The basis of this research is evidence of the effectiveness in the CASI system, the~     growing public health issue of alcohol abuse, the need to be able to provide effective~     screening and brief intervention in the high volume ED settings, and findings that the~     primary method to reduce traumatic death is prevention.~   "
105166|NCT01680601|"~     Surgical correction of congenital heart defects in children requires the utilization of~     cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions~     during surgery. During this process the patient´s circulation is controlled by a bypass~     machine which provides several functions:~        1. Controls the patient's blood flow by pumping of blood in the patient's body.~        2. Controls the correct oxygen levels in the patient's blood.~        3. Regulates the temperature and fluid level of the blood. This process triggers negative~          responses in the heart and throughout the whole body, potentially resulting in injury~          to the heart and other organs such as brain, kidneys and lungs.~      Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce~     the injury to heart muscle during cardiac surgery. The procedure consists of the inflation~     of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by~     briefly reducing blood flow to the leg muscle, which will then activate the body´s own~     protective mechanisms and thereby reduce heart injury.~      Several animal studies have been used to help the understanding of the mechanisms behind~     this process, and trials in human adults have showed optimistic results; however evidence~     regarding the paediatric population is limited and necessary since children present~     different basal profiles, risks and requirements.~      The investigators propose a randomized clinical trial assessing the efficacy of RIPC to~     provide protection against injury to the heart and other organs in children going through~     cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will~     have a translational approach, integrating basic molecular mechanisms to clinical outcome.~     The investigators hope it will allow the understanding and utilisation of the patient´s own~     protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.~   "
105167|NCT01680588|"~     This is a phase 2, open-label, multiple-center, non-randomized single dose study to assess~     the safety and efficacy of [18F]NAV4694 PET imaging in detecting beta-amyloid plaque in the~     brain in subjects with probable AD compared with healthy volunteers.~   "
105168|NCT01680575|"~     To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia~     induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian~     cancer and to validate this model.~   "
105169|NCT01680562|"~     In vivo differentiation of benign and malignant skin lesions is a fundamental issue in~     clinical dermatology. Malignant skin diseases are known to be accompanied by structural~     alterations. Conventional excisional biopsies and further histopathology are regarded as the~     reference standard for investigating these pathologies. Biopsies are invasive procedures and~     additionally may cause side effects. Therefore, research efforts are focused on the~     development of diagnostic techniques capable of providing in vivo information on the skin's~     structure. Optical coherence tomography (OCT) is a technical application, which allows the~     identification of microscopic patterns indicative for benign and malignant skin lesions. OCT~     is a promising noninvasive imaging technique for the micromorphology of the skin. So far,~     it's clinical application, as an additional diagnostic tool for malignant skin lesions has~     been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a~     prospective pilot study at the Department of Dermatology, Medical University of Vienna. The~     study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical~     University of Vienna.~      A total of 70 malignant skin lesions was evaluated during this prospective pilot study.~     Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those~     based on the clinical standard pathway at the Department of Dermatology, Medical University~     of Vienna. For the purpose of this study, the histopathological diagnosis was used as the~     reference diagnostic standard.~      The major aims of this study is the investigation of the ability of ultrahigh resolution OCT~     to identify fine morphological characteristics associated with basal cell carcinoma, actinic~     keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and~     melanoma.~        -  To correlate the morphologic features identified with ultrahigh resolution OCT with~          routine histopathology~        -  To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT~          technology~        -  To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to~          diagnose various melanocytic and non-melanocytic skin tumors~        -  To compare the diagnostic capabilities of ultrahigh resolution OCT with standard~          non-invasive diagnostic procedures such as epiluminescence microscopy~   "
105170|NCT01680549|"~     The purpose of this project is to study the effects of gabapentin on pain control in the~     perioperative and post-operative period of total knee arthroplasty.~   "
105194|NCT01680237|"~     Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety~     disorders. Although the efficacy of psychological treatment for panic disorder with~     agoraphobia has been the subject of a great deal of research, studies comparing~     cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect~     small to moderate differences. Therefore, the primary purpose of the present study is to~     investigate if the combination of cognitive techniques with exposure in vivo is superior to~     the effects of exposure alone for patients with moderate to severe agoraphobia.~   "
105253|NCT01679470|"~     This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy~     in the treatment of subjects with primary and/or metastatic tumors of the lung where there~     is airway obstruction. In this study patients will be given a systemic IV infusion of~     particles and a subsequent escalating dose of laser radiation delivered by optical fiber via~     bronchoscopy.~   "
105171|NCT01680536|"~     The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug~     maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many~     people successfully take only darunavir/ritonavir treatment for their HIV. However, there~     are some concerns that this treatment may not reach some areas of the body, such as the~     brain and spinal cord (central nervous system or CNS), as effectively as it does the~     bloodstream.~      There is already a large clinical study looking at any differences between 'conventional'~     HIV treatment with 3 drugs and single drug treatment with a protease inhibitor, also called~     PI monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the~     CNS. However, this study will only be finished in 2013.~      The investigators know that maraviroc can reach the CNS very effectively. The investigators~     in this study will investigate the effect of adding maraviroc to darunavir/ritonavir~     monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,~     called cerebrospinal fluid or CSF.~      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in~     2 clinical studies when it was taken by people whose HIV virus had developed resistance to~     previous HIV treatments.~      This study will also investigate safety as well as monitor effectiveness when patients take~     maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.~      Maraviroc has been shown to be present in the fluid that surrounds the brain in people~     taking Maraviroc. It is not known if whether the presence of Maraviroc has any impact on~     brain function. Therefore this study will also investigate brain (neurocognitive)~     functioning with a computer test and some written tests.~   "
105172|NCT01680523|"~     To compare 5-year overall survival between patients who undergo radical hysterectomy~     followed by tailored adjuvant therapy and patients who receive primary chemoradiation~     therapy in FIGO stage IB2 and IIA2 cervical cancer~   "
105173|NCT01680510|"~     Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration~     starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding~     disease in Israel in 2004 [7% of all blindness]. The investigators treated a non-progressive~     form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from~     alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella~     Bardawil accumulates high concentration of β -carotene when grown under appropriate~     conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β~     carotene and 50% 9-cis β -carotene.~      The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro~     in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The~     night vision, as measured objectively by electroretinography (ERG) more than doubled in six~     patients tested following treatment. The visual field was also improved significantly. In a~     more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis~     b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial.~     Significant improvement in retinal function was recorded in 34% of the patients.~   "
105174|NCT01680497|"~     A prospective, open-label, multi-center, observational, post-market study evaluating~     JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds~   "
105175|NCT01680484|"~     There are multiple factors affecting the variability and acceleration pattern of fetal heart~     rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any~     factor decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be~     stimulated by manual manipulation, sound, light, change in maternal position and maternal~     ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently~     practiced in outpatient settings. This is not only medical but also a social routine. In~     this study the investigators have chosen the two most popular so-called 'fetal~     accelerators', chocolate and orange juice against no intervention and tried to find any~     usefulness of these on non-reactive NST patterns.~   "
105176|NCT01680471|"~     Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating~     airway properties, has acquired widespread acceptance in children. However, sevoflurane has~     been reported to be associated with emergence agitation in children, with a reported~     incidence of up to 80%.~      The purpose of this study is to verify that the prophylactic use of midazolam, which is a~     GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces~     the incidence of emergence agitation after sevoflurane anesthesia in children.~     Simultaneously, this study aims to find out the proper dose of midazolam with minimum~     disturbance to patient's emergence time.~   "
105177|NCT01680458|"~     To collect the efficacy and safety information of fluconazole on infant subjects related to~     their appropriate use in daily practice.~   "
105178|NCT01680445|"~     The telephone interviews will be conducted to gather information on goal setting and goal~     attainment from men and women with osteoarthritis.~   "
105179|NCT01680432|"~     Constipation is a common gastrointestinal motility disorder, chronic condition that often~     negatively affects the daily lives of patients due to their symptoms, such as infrequent~     stools, hard stools, straining or painful defecation, cramping, bloating and flatulence.~     Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to~     the onset of constipation. One way to reduce constipation through nutritional management of~     affected individuals is through consumption of probiotic products, which beneficially affect~     the development of microbial flora in the intestine, helping to improve the symptoms of~     constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis,~     which according to its maker, when consumed as part of a healthy diet, presents beneficial~     effects in improving symptoms of constipation.~      Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms~     constipation.~   "
105180|NCT01680419|"~     An urgent and growing need exists for interventions that support the long-term adjustment~     and mental health needs of OIF/OEF veterans and their relationship partners after the return~     from deployment. This project will complete production of a multimedia intervention program~     for autonomous use, delivered by Internet and mobile app technology, that teaches couples~     selected mind/body interventions and massage techniques to promote stress reduction,~     compassion, resiliency and relationship re-integration. A four-armed randomized trial will~     evaluate mental health outcomes as a free-standing program and as complementary to a current~     standard of care structured group program.~   "
105204|NCT01680107|"~     The purpose of this study is to determine whether d-cycloserine augments the clinical~     effects of exposure-based cognitive-behaviour therapy for panic disorder.~   "
105181|NCT01680406|"~     The investigators hypothesize that the addition of primaquine (PQ) to both~     artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax~     infection will result in decreased chance of relapse by about 60%.~      The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ~     and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine~     the number of recurrent vivax episodes in patients receiving PQ compared to those who don't~     receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers~     will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.~      Phase 1 of the study will monitor the clinical, parasitological, and hematological~     parameters for P. vivax infection over a 42-day follow-up period, which will be used to~     evaluate drug efficacy. Phase 2 will continue monthly follow-up of these patients for one~     year to assess frequency of recurring vivax infections. Results from this research study~     will be used to assist Ethiopia in assessing their current national malaria drug policies.~   "
105182|NCT01680393|"~     This study is a 3-legged randomized study examining whether during shoulder surgery~     performed in the beach chair position active compressions of the lower leg with a sequential~     compression device (SCD) have a superior effect on stabilizing cerebral and circulatory~     hemodynamics when compared to TED stockings or a control group without any stockings.~   "
105183|NCT01680380|"~     The purpose of this study is to evaluate the feasibility of tracking breathing during sleep~     with non-contact sensors (for example, microphones or wireless movement sensors). The~     investigators will use the data collected with these sensors to develop algorithms for~     tracking breathing during sleep. The investigators will assess the performance of the~     algorithms by comparing automatic output against manually-generated labels.~   "
105184|NCT01680367|"~     This study is to determine what dressing would work best to heal and keep from hurting, the~     split-thickness skin graft donor site which will be done as part of the patient's surgical~     procedure. Currently there is a dressing that is transparent and it is placed on the wound~     after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the~     gauze and elastic bandages are removed and the area is left with the transparent dressing.~     Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing~     is removed and the wound is left open to air. The dressing researchers are studying is a~     dressing that has been used for different types of wounds, as well as this type of wound. It~     is applied in the same manner; however, it is left in place until it falls off~     independently, usually around post-operative (post-op) day 10.~   "
105185|NCT01680354|"~     Laser correction for myopia and astigmatism using an excimer laser has been performed with~     success for several years.~      During the last 2 years, a new method for correction of refractive errors has emerged. In~     the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that~     is subsequently removed. For simple myopia this method has proved effective and on par with~     excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the~     treatment of astigmatism.~      In the study, patients with high astigmatism are treated with conventional LASIK for~     astigmatism in one eye and with ReLEx for astigmatism in the other.~   "
105186|NCT01680341|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of the trial is to compare the efficacy and safety of two different titration~     algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes~     mellitus previously treated with insulin glargine.~   "
105187|NCT01680328|"~     This trial is conducted in Europe. The aim of this trial is to assess and describe the pain~     in relation to subcutaneous (under the skin) injection of different combinations of~     injection speed and volume with respect to acceptance of the injection pain and backflow.~   "
105188|NCT01680315|"~     The regulation of our food intake is on the short-term guided by appetite and satiety~     signals generated by the sight and consumption of food. Food intake is not only regulated by~     appetite and satiety signals - external cues also play an important role.~      It has been observed that food intake and the pleasure derived from consumption is affected~     by manipulation of the external cues.~      The investigators will assess the contribution of food anticipation (calorie information)~     and actual consumption of a test food (calorie intake) on in satiety responses (such as~     ghrelin responses, appetite and subsequent food intake). The investigators expect the~     information on the amount of calories, rather than the actual amount of calories in the~     food, to predict the ghrelin responses and the subsequent intake of a second meal.~   "
105189|NCT01680302|"~     This is a substudy of Generation 100. In that study, 4000 healthy persons between 70 and~     75 will be randomised do moderate intensity, high intensity or control group, with 3 years~     of exercise. The investigators will follow these persons and register all who develop atrial~     fibrillation during these 3 years, and at follow-up after ended intervention to see if there~     is differences in the number of persons who develop atrial fibrillation in the 3 groups.~   "
105190|NCT01680289|"~     The aim of this study is to determinate the influence of an alternative adhesive application~     protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity~     in primary molars.~   "
105191|NCT01680276|"~     Many people with intellectual disability have challenging behaviour which often has serious~     consequences such as the prescription of long term medication, in-patient admissions and~     disruption of normal daily activities. Community intellectual disability services may have~     difficulties in helping people with challenging behavior. Available research suggests that~     Positive Behavior Support (PBS), a training system that teaches staff how to manage these~     situations, can benefit service users who may show improvements in challenging behavior and~     quality of life. The investigators do not know of any study so far that has examined the~     clinical and cost effectiveness of PBS that is provided by staff in routine clinical~     practice in community intellectual disability services. If PBS proved to be better than~     treatment as usual, it would have important implications for the management of a very~     vulnerable group of service users. In this trial, health staff will receive accredited~     training in PBS available in a manual written by PBS experts. It will give details of how to~     understand challenging behavior and develop a management plan and how to implement it and~     monitor whether it has achieved its goals. Twenty community intellectual disability services~     and 260 service users with mild to severe intellectual disability and challenging behavior~     will be invited to take part in the study. The sample size calculations are based on our~     pilot study and allow for non participation of 10% and inflation due to the number of~     community intellectual disability teams and staff that will take part. The teams will be~     randomly allocated into one of two conditions. Half will be in the PBS arm (but will also~     have treatment as usual) and half will be in the treatment as usual only group. The~     investigators will carry out assessments of challenging behavior, use of services, quality~     of life, mental health, aggression and family and paid carer burden at six and 12 months.~     The investigators will monitor treatment fidelity and the investigators will talk to a~     sample of paid and family carers, service users, staff and managers about what they think of~     the treatment and how best the investigators can deliver it in routine care. The main~     outcome is reduction in challenging behavior at one year after the randomization. The~     investigators will also carry out a health economic evaluation to examine the costs and~     consequences of staff training in PBS.~   "
105195|NCT01680224|"~     Obesity is a major US public health problem. Few obesity prevention programs have reduced~     risk for weight gain over follow-up and those that have are very intensive, making~     dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy~     Weight) targeting young adults with body dissatisfaction involving participant-driven~     healthy dietary and physical activity lifestyle changes significantly reduced increases in~     body mass index (BMI) and obesity onset relative to alternative interventions and~     assessment-only controls through 3-yr follow-up, though effects were small in magnitude. To~     enhance efficacy, the investigators added dissonance-inducing activities regarding unhealthy~     dietary and activity practices, drawing from a highly efficacious dissonance-based eating~     disorder prevention program. A pilot trial found that this new Project Health intervention~     significantly reduced increases in BMI relative to both the Healthy Weight intervention and~     an educational brochure condition from pre to post. The investigators propose to conduct a~     rigorous multisite effectiveness trial that will test whether adding the~     dissonance-induction elements to the originally Healthy Weight intervention improves weight~     gain prevention effects. 360 college students at risk for future weight by virtue of their~     age and weight concerns will be randomized one of three conditions: (1) a refined 6-hr~     group-based dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight~     intervention, or (3) a psychoeducational video (Weight of the World) condition.~     Participants will complete assessments of % body fat, mediators (including objectively~     measured physical activity), moderators, and other outcomes at pre, post, and 6, 12, and 24~     month follow-ups.~   "
105196|NCT01680211|"~     Objective of this study is to determine the safety and efficacy of administration of herbal~     supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks~     in the management of prediabetes and mild to moderate hyperlipidemia.~   "
105197|NCT01680198|"~     The primary aim of this study was to test the hypothesis that Paricalcitol, an active form~     of vitamin D, improved endothelial function in stage 3-4 chronic kidney disease (CKD)~     patients. A secondary aim of this trial was to study the relationship between endothelial~     function and plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD)~     and renin angiotensin-aldosteron system (RAS) (angiotensin II and plasma renin activity).~   "
105198|NCT01680185|"~     The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment~     with short acting insulin, applied continuously through an insulin pump, (i) improves~     glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers~     further β-cell protection, in comparison to the standard of care control group, and the~     basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented~     insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic~     events. Patients in the SAPT-NODAT study will be followed through 24 months~     post-transplantation.~   "
105199|NCT01680172|"~     Depression is common in patients with cancer. Current medications for depression, while~     effective, take several weeks to take effect. Ketamine has emerged as a drug with promise~     for cancer patients. In two reported cases, a single dose of ketamine induced rapid and~     moderately sustained symptom reduction in depression and anxiety with no adverse side~     effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is~     a randomized, double-blind, placebo-controlled investigation testing whether a single dose~     of ketamine improves depression and anxiety relative to placebo in patients with cancer.~   "
105200|NCT01680159|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650~     at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the~     treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but~     decreased thereafter.~   "
105201|NCT01680146|"~     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a~     major impact on our healthcare system due to increased morbidity and greater need for~     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to~     improve dietary intake of the elderly. It has already been shown that ingestion of dietary~     protein stimulates muscle protein synthesis and inhibits muscle protein breakdown, resulting~     in an overall positive net protein balance. However, the impact of fat (as part of the meal)~     on dietary protein-induced muscle protein synthesis remains largely unknown. Based on~     previous studies by other research groups, we hypothesize that fat further stimulates the~     muscle anabolic response to protein ingestion.~      Objective: The primary objective of this study is to investigate the effect of a single~     meal-like amount of protein with or without fat on postprandial muscle protein synthesis~     rates in healthy elderly men. Furthermore, as a secondary objective, we will assess~     digestion and absorption kinetics.~      Study design: double-blind randomized intervention study Study population: 24 healthy~     elderly men (55-85 y) Intervention: one group (n=12) will consume a test beverage of 350 mL~     containing 20 g of intrinsically labeled casein, and the other group (n=12) will consume a~     beverage of the same volume containing 20 g of casein plus 20 g of fat.~      Main study parameters/endpoints: Primary endpoint: muscle protein synthesis rates. Secondary~     endpoint: digestion and absorption kinetics.~   "
105202|NCT01680133|"~     Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent~     excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could~     play an important role in the development and exacerbating of insulin resistance. Therefore,~     the investigators propose to study the regulation of adipose tissue and skeletal muscle~     lipolysis, as well as further characterize the intracellular lipolytic pathways within these~     tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.~   "
105203|NCT01680120|"~     Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be~     challenging in some cases like in haemodynamical unstable patients.~      The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip~     replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF~     is still unknown.~      A step-up/step-down methodology was used successfully in regional anaesthesia and also in~     other areas of anaesthesia.~      In pregnant ladies in whom spinal anaesthesia is performed on the side, significant~     correlation exist between the vertebral length measured from cervical 7 to the iliac creast~     and MLAD.~      The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required~     for Continuous spinal anaesthesia for the operative fixation of FNF.~   "
105207|NCT01680068|"~     Macular hole is a hole formation which takes place in the center of the retina. Such a hole~     needs surgical steps in order to close. Closure of the macular hole will lead to a~     substantially improvement of vision in most cases. Following macular hole surgery a~     tamponade of intraocular gas is normally injected in order to keep the macula dry for the~     postoperative period. Postoperative face down position for a week was earlier standard.~     Several authors report of good closure rates with both air tamponade or lack of face down~     positioning. In this study standard pars plana vitrectomy with peeling of the internal~     limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air.~     Postoperative face down positioning will not be used.~   "
105208|NCT01680055|"~     This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for~     the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed~     aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine~   "
105209|NCT01680042|"~     several studies have investigated healing effect of phenytoin.In this study we investigate~     healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste~     after oral biopsy.~   "
105210|NCT01680029|"~     To evaluate the performance and safety of the PBASE-system when used in the treatment of~     acute migraine episodes of moderate to severe intensity. The study will evaluate the effect~     of treatment on migraine pain and symptoms during an acute attack and also any long-term~     effect.~   "
105211|NCT01680016|"~     This study was designed to evaluate the safety and immunogenicity of two simulated~     postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese~     children and older adults.~   "
105212|NCT01680003|"~     This is a multi-center, double blind, parallel group placebo controlled randomised trial~     designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus~     Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for~     a treatment period of 48 weeks~   "
105213|NCT01679990|"~     The objective of the study is to establish the safety profile of~      Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects~     comprising of 4 treatment groups:~        1. Double treatment of PLX-PAD low dose~        2. Double treatment of PLX-PAD high dose~        3. Double treatment of Placebo~        4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects~          will receive the assigned treatment twice to the affected leg, within 12-weeks interval~          between each treatment.~      The study will be comprised of 5 stages:~      Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by~     additional injection after 12 weeks and with follow-up of 12 months post second injection~   "
105214|NCT01679977|"~     Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two~     different types of training.~   "
105215|NCT01679964|"~     Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable~     HIV-infected adult patients receiving combination therapy will demonstrate improved clinical~     tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).~   "
105216|NCT01679951|"~     The purpose of this dose range finding study is to assess the effectiveness, safety and~     tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in~     patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX)~     therapy.~   "
105217|NCT01679938|"~     The overall objective is to determine the impact of comprehensive, multifaceted, child~     care-based intervention to prevent obesity among children 2 through 5 years of age. The~     specific aims are:~        1. To determine the extent to which the intervention, compared with the control condition,~          results in a smaller age-associated increase in body mass index (BMI) after a 6-month~          intervention (primary outcome) and a 1-year follow-up period among children.~        2. To determine the extent to which the intervention, compared with the control condition,~          reduces the proportion of children who are obese (BMI >95th percentile for age and~          sex).~        3. To determine the extent to which the intervention, compared with the control condition,~          results in:~             1. improved dietary, physical activity and television-viewing behaviors among~               children, specifically, reducing the consumption of sugar-sweetened beverages,~               high calorie/low nutrient-dense snack foods, and fast food, increasing active~               time, and reducing TV/video viewing time;~             2. improved home food and activity environment, specifically, decreasing availability~               of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and~               increasing parental support for healthy eating and regular physical activity;~             3. improved child care center food and activity environment, specifically, increasing~               opportunities for healthy eating and physical activity, and increasing support and~               encouragement of children's behavior change by child care providers;~        4. To assess the feasibility and acceptability of the intervention among child care~          providers and families.~      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS~     child care centers in Mexico City. The investigators will randomly assign 8 child care~     centers to the intervention condition and 8 to an assessment-only control condition.~      Multifaceted intervention. The resulting intervention will involve four main components:~        1. Training of child care providers.~        2. Curriculum sessions for children.~        3. Family outreach activities.~        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),~          changes in child's key obesity-related behaviors, changes in the child's home food and~          activity environment, and changes in child care food and activity environment. At the~          intervention and control child care sites, changes from baseline to one year for all~          outcome variables will be measured.~   "
105218|NCT01679925|"~     GnRH agonists are used in the treatment of precocious puberty in order to improve adult~     height.However,the psychosocial impact of precocious puberty is often used by the clinician~     at diagnosis to justify treatment, but can not yet be properly assessed. It can not be~     considered as a rational neither for the indication to treatment, nor to assess its~     potential efficacy.~      The overall objective of this work is to improve the conditions leading to the therapeutic~     decision and the procedures for monitoring girls with idiopathic central precocious puberty.~   "
105219|NCT01679912|"~     This clinical trial aims to compare morbidity and cost associated with acute attacks of~     hereditary angioedema in patients with an intervention based on a support after a phone call~     to the call center (SOS HAE) from a group of patients does not change their practice.~   "
105220|NCT01679899|"~     This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to~     compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone~     Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.~      A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The~     active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,~     gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.~   "
105221|NCT01679886|"~     The main objective of this study will be to compare the diagnostic performances of~     82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with~     CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of~     myocardial ischemia in a population of overweighed patients on one hand, and women on the~     other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3~     cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the~     DIAMOND-FORRESTER score in symptomatic patients).~   "
105222|NCT01679873|"~     Objective: The aim of this study is to assess the impact of reporting, in abstracts of~     randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs)~     of the authors on General Practitioners' confidence in the abstracts' conclusions.~      Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP).~     They will be recruited among residents from the Primary Care department of the Paris~     Descartes University and among a GP network who agreed to participate to research studies.~      The allocation of participants will be done by a computerized randomization list, the~     sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants~     will be blind of the hypothesis and of the randomization. Allocation concealment will be~     provided because only the statistician will have access to the randomization list.~      Methods: Three interventions will be assessed corresponding to three different types of~     abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors,~     2) abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs~     of authors.~      A sample of abstracts will be selected from published randomized trials, testing~     superiority, assessing pharmacological treatment, in the field of Primary Care and General~     Practice and having a conclusion in favor of the beneficial effect of experimental treatment~     in terms of tolerance and / or efficacy. They will then be standardized and modified to~     obtain three types of abstracts: 1) with funding sources, 2) with funding sources and COIs~     and 3) without either source of funding or COIs.~      Participants will be asked to assess one abstract of their randomization arm. Outcome: The~     primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be~     the quality perception of the study and the interpretation of the benefit of experimental~     treatment. Responses will be ranged by a 10-point numeric scale.~      Potential interests: This study takes place in the field of Primary Care. We believe that~     better understandings of impact of funding sources and conflicts of interests are necessary~     to allow more transparency in medical research and in his translation into medical practice.~      Sample size expected: 354 participants.~   "
105223|NCT01679860|"~     Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall~     survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell~     transplantation (allo-STC) may have a curative role for these pts but its toxicity is high~     when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease~     transplant related toxicity and mortality. The investigators have recently proved~     feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.~      We want to investigate whether it is possible to improve the outcome of alk negative PTCL~     pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.~      The intensification will be obtained by combining intensive chemotherapy, alemtuzumab~     (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years~     (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between~     61 and 70 years(Clinical Study B).~   "
105224|NCT01679847|"~     The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier~     penetration of the elemene.~   "
105225|NCT01679834|"~     This multicenter, observational study will assess the efficacy and the safety of Pegasys~     (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.~     Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to~     local guidelines. Data will be collected for 96 weeks.~   "
105226|NCT01679821|"~     It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State~     University of West of Parana's dental students with natural dentition, in patients with~     removable partial dentures and double complete dentures.~   "
105227|NCT01679808|"~     Background. Do pressure dependent tracheal obstructions (PDTO) often seen during~     bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms?~     Method. Model study. A garden hose was compressed from one side to simulate the posterior~     wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm,~     the hose was increasingly compressed in eight steps. Resistance was measured at each step~     for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which~     were used by a computer to estimate the cross sectional area reduction and the corresponding~     distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).~      Patient study. 104 stable COPD patients studied by pulmonary function tests and~     bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and~     the cross sectional area reduction was estimated using the results from the model study.~   "
105228|NCT01679795|"~     The aim of this study is to evaluate the vascular effects of tibolone on climateric women~     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound~     and compare to placebo.~   "
105229|NCT01679782|"~     The purpose of this study is to determine whether nervous system alterations and motor drive~     failure can contribute to muscle weakness in COPD during voluntary movement. If necessary,~     we will look after the role of nocturnal hypoxia in these alterations.~   "
105230|NCT01679769|"~     The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and~     radiology methods in patients with chronic hepatitis B in mainland China.~   "
105231|NCT01679756|"~     The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal~     anastomosis (EA) after laparoscopic right hemicolectomy for cancer.~   "
105232|NCT01679743|"~     Background:~      - Brain metastases are cancer cells that have spread to the brain from primary cancers in~     other organs. These tumors can be removed surgically. However, researchers are trying to~     find better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross~     into the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers~     want to see how well GRN1005 works on brain metastases from breast or lung cancer.~      Objectives:~      - To test the safety and effectiveness of GRN1005 in treating brain metastases from breast~     or lung cancer.~      Eligibility:~      - Individuals at least 18 years of age who have breast or lung cancer that has spread to the~     brain.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor tissue samples may also be collected. Imaging studies~          will also be performed.~        -  Participants who have breast cancer will be divided into two groups. Those whose cancer~          contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005.~          Those without HER2 will have only GRN1005.~        -  Participants who have lung cancer will also have only GRN1005.~        -  All participants will have two doses of GRN1005, each 3 weeks apart. On the day the~          second dose of GRN1005 is given, participants will undergo surgery to remove the brain~          tumors.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
105233|NCT01679730|"~     To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome~     patients by hydrogen breath test and molecular-based analysis of microbiota in~     gastrointestinal tract~   "
105290|NCT01678989|"~     Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of~     children of BD parents and diagnosed with and BD children whether or not brain has affected~     zones. These groups were compared to healthy controls and whether or not the mental health~     of children is influenced will be evaluated by the clinical investigation.~   "
105234|NCT01679717|"~     In this randomized controlled trial the investigators want to investigate whether early~     versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a~     faster recovery of hand function. The investigators also want to explore patients'~     satisfaction with the two different treatment regimes. The participants in the control group~     will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb~     in a splint for six weeks. The participants in the intervention group will use a soft splint~     for six weeks, but will be instructed to remove the splint daily to perform exercises for~     the thumb. A total of 70 patients will be included in the study.~   "
105235|NCT01679704|"~     This study is initiated to investigate the glycemic index value of ten food products.~   "
105236|NCT01679691|"~     Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain~     control intra and more importantly post-operative pain. It is a well-known effect of~     epidural injections to cause a sympathetic stimulation and consequently vasodilatation in~     the lower limb vessels.~      Since epidural catheters can cause vasodilatation in lower limb vessels, they can~     subsequently lead to increased intra and post-operative bleeding from the surgical wound.~      The study will involve all patients having a bone tumor in the lower limb and subjected to~     tumor resection and reconstruction by prosthesis.~      The patient will be randomized according to the administration of epidural anesthesia into~     two arms, an arm in which epidural anesthesia was employed and another arm in which the~     patient was subjected only to general anesthesia and the amount of intra and postoperative~     bleeding will be compared in both arms.~   "
105237|NCT01679678|"~     This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety~     and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical~     control. The study will enroll adult subjects with post traumatic/post surgical, venus~     insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be~     followed for 12 weeks.~   "
105238|NCT01679665|"~     Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1~     and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good~     safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the~     candidate vaccine for the phase 3 clinical trial.~      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene~     expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5~     years old use a systems biology approach combined with microarray analysis，RT-PCR and~     neutralizing antibody testing for PBMC and serum collected form the studied children~     population, to predict immunogenicity, and explore mechanistic insights about the EV71~     vaccine.~   "
105239|NCT01679652|"~     Investigators want investigate the following hypothesis:~        1. Nebivolol increases nitric oxide activity in the systemic circulation and the kidney~        2. The increased activity of nitric oxide during nebivolol treatment can be demonstrated~          by inhibition of NO synthesis with L-NMMA. We expect increased responses in blood~          pressure and sodium excretion is expected during nebivolol treatment compared to~          placebo.~   "
105240|NCT01679639|"~     This open-label, fixed-sequence, three-period, single group study will evaluate the effects~     of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will~     receive single doses of aleglitazar in all three periods and single doses of rifampicin in~     periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is~     up to 14 weeks.~   "
105241|NCT01679626|"~     In anesthesia, intubation is a technique used to secure an airway. This technique is not~     always straightforward. Sometimes it is difficult to place an endotracheal tube. There are~     two manners of giving pressure to the patients neck, to improve view and facilitate~     intubation.~      The investigators hypothesize that by giving this pressure the effective work area is likely~     to be smaller. The investigators would like to quantify this effect by measuring the~     effective work area, using a specially designed computer program.~   "
105242|NCT01679613|"~     The objective of the current study is to investigate the relative bioavailability of a~     single dose of nintedanib low or high dose with and without coadministration of ketoconazole~     at steady state~   "
105243|NCT01679600|"~     The propose of this study is to evaluate the feasibility and the clinical efficiency of~     feedback-controlled robotics-assisted treadmill exercise (RATE) technology for~     cardiovascular rehabilitation early after stroke. The investigators hypothesize that~     feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness~     and functional carryover in non-ambulatory individuals with sub-acute stroke.~   "
105244|NCT01679587|"~     Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat~     (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were~     to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin,~     reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat,~     exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional~     pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide,~     vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine~     monophosphate, and noradrenaline~   "
105245|NCT01679574|"~     The purpose of this study is to compare and determine the efficacy of letrozole~     administration to that of combined metformin and Clomiphene in infertile women with~     polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent~   "
105246|NCT01679561|"~     Both organ-specific and systemic autoimmunity are associated with an increased prevalence of~     recurrent miscarriage and reproductive failure, rendering the role of the maternal~     immunological system in fertility a key concept. It is believed by some that central to this~     theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune~     modulating therapies have therefore been mooted as potential therapeutic strategies. Recent~     reports of high pregnancy rates achievable in women with RIF have added fuel to the debate~     regarding the effectiveness of intralipids in modulating the immune system.~   "
105247|NCT01679548|"~     To compare the efficacy between single-port and three-port laparoscopic assisted vaginal~     hysterectomy in patients with benign or preinvasive uterine disease~   "
105248|NCT01679535|"~     This study will determine if an education program about hygiene and child feeding practices,~     taught by local village community health workers, will improve child growth and decrease the~     prevalence of childhood malnutrition in a rural region of Kenya.~   "
105254|NCT01679457|"~     The objective of this study is to learn how to improve treatment for clients who are working~     hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but~     who are not making the progress that would typically be expected. Therefore, the~     investigators will be comparing the performance of such clients in a treatment as usual~     (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance~     and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The~     investigators hypothesize that clients will perform significantly better in the ACT-focused~     ERP session than they will in the TAU-ERP session. More specifically, the investigators~     hypothesize that clients and an independent rater will report that in the ACT-focused ERP~     session, clients performed significantly fewer rituals and/or avoidance behaviors, exerted~     significantly more effort, had significantly less difficulty getting started with the ERP,~     were significantly less influenced by their uncomfortable thoughts/feelings, were~     significantly more willing to experience discomfort, were significantly more focused on~     working towards what is important to the client. The investigators also hypothesize that an~     independent rater will rate clients as significantly more compliant with the ACT-focused ERP~     session than with the TAU-ERP session. The investigators also hypothesize that clients will~     rate the ACT-focused ERP session as significantly more preferable and acceptable than the~     TAU-ERP session, and that they will report being significantly more willing to do the~     ACT-focused ERP session again.~   "
105255|NCT01679444|"~     This protocol will investigate the neurobiological underpinnings of alcohol craving in~     recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This~     clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and~     other brain metabolites correlate to measures of alcohol craving severity~   "
105256|NCT01679431|"~     Calcific aortic stenosis (AS) has become the most common cardiac disease after coronary~     artery disease and hypertension. Unfortunately no medical therapies have been proven to~     decrease either the progression of valve stenosis or the resulting adverse effects on~     myocardial remodeling and function. In light of the studies performed in PROGRESSA, it~     becomes obvious that: i) AS is a complex and actively regulated process that involves the~     interaction of several pathways including lipid infiltration and retention, chronic~     inflammation, osteogenic activation, and active mineralization within the valvular tissues;~     ii) AS is not a disease strictly limited to the aortic valve but rather a systemic disease~     that often involves calcification and stiffening of the aorta and impairment of LV function~     as a consequence of pressure overload. Our findings suggest that the dysmetabolic milieu~     linked to visceral obesity may accelerate the deterioration of the structure and function~     not only of the aortic valve but also of the aorta and of the left ventricle. These findings~     open new avenues of research and provide strong impetus for the elaboration of prospective~     studies focusing on the valvulo-metabolic risk in AS.~      The general hypotheses are: The metabolic abnormalities linked to visceral obesity~     accelerate (1) the progression of valvular calcification and stenosis, aortic calcification~     and stiffness; (2) the progression of myocardial fibrosis and dysfunction.~      The general objectives of the study are to elucidate the mechanisms implicated in the~     pathogenesis of AS and to identify the metabolic factors that determine the progression of:~     i) aortic valve calcification and stenosis; ii) myocardial fibrosis and dysfunction; and~     iii) clinical outcomes.~      This study will contribute to identifying the key metabolic determinants of AS progression~     and will pave the way for the future development of non surgical therapies for this disease.~     The results of this study would provide strong support to the realization of randomized~     trial to test the efficacy of lifestyle modification program or new pharmacological~     treatment aiming at the reduction of visceral fat and associated metabolic abnormalities in~     the AS population. Furthermore, this study will contribute to the identification of novel~     blood and imaging biomarkers of faster disease progression, which will help to optimize risk~     stratification and timing of AVR in the AS population.~   "
105257|NCT01679418|"~     Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and~     Vomiting (PONV)~   "
105258|NCT01679405|"~     An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy~     of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients~     with advanced and/or metastatic adenocarcinoma of the biliary tract~   "
105259|NCT01679392|"~     In this study we investigate the following properties of the transversus abdominis plane~     block in healthy volunteers:~        1. Cutaneous analgesic distribution~        2. Muscular affection~        3. Reproducibility~   "
105260|NCT01679379|"~     The purpose of this study is to determine the surgical site infection rate and patient~     satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean~     section in obese women.~   "
105261|NCT01679366|"~     The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult~     patients may shorten the duration, and reduce the severity of the disease.~   "
105262|NCT01679353|"~     A caudal anesthesia is one of the most commonly used technique providing intra and~     postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct~     analgesic drugs to local anesthetics for caudal block is common. The most commonly used~     drugs are opioids, clonidine, and ketamine. However, their use has been limited by adverse~     effects in children.~      Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is~     the fourth most abundant cation in the body. It has antinociceptive effects in human and~     these effects are primarily based on the regulation of calcium influx into the cell.~     Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)~     receptor and such NMDA antagonism prevents the central sensitization from nociceptive~     stimulation. Many study suggested that epidurally administered magnesium could reduce the~     postoperative pain in adults. But few studies are available about the use of magnesium in~     pediatrics.~      The investigators performed prospective randomized double-blind study to examine the~     analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia~     on postoperative pain control in pediatric patients undergoing inguinal hernia repair.~      80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this~     prospective, randomized, double-blinded study. After inhalation induction of general~     anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal~     saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium~     50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative~     pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale~     (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants~     will be followed for the duration of hospital stay, an expected average of 3 hours.~      After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain~     Measurement, PPPM), and adverse effects were evaluated for 48h.~      The time to first supplemental oral analgesic medication demand was defined as the time from~     the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation.~     48 hours after surgery, reports of delayed side effects and demands for rescue analgesics~     from the child were gathered from parents via a telephone interview.~   "
105263|NCT01679340|"~     To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and~     III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less~     toxicity.~   "
105264|NCT01679327|"~     This study evaluates the relationship of biomarker expression and efficacy of bevacizumab~     plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the~     treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3~     expression in tumor tissue by IHC and detect those protein expression level in plasma by~     ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D~     expression level in plasma by ELISA. The aim of the study is to identify whether those~     biomarkers could predict Bevacizumab efficacy.~   "
105291|NCT01678976|"~     To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single~     900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a~     single 900 mg dose of BIA 2-093 and Oxcarbazepine.~   "
105265|NCT01679314|"~     The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease~     (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day~     over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham~     device during these two months while not knowing which device they have been provided. At~     the end of the two months, all patients will be asked to continue in the study for another 2~     months to self administer with the active AlphaCore device. Subjects will complete diaries~     at home on their breathing and quality of life and will return to the clinic monthly for~     assessment by the investigator.~   "
105266|NCT01679301|"~     The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30~     participants (to allow for 20 completers) with a prescription for nocturnal oxygen, and~     meeting all eligibility criteria. All participants will undergo a single night~     polysomnography testing in a sleep lab while they're SpO2 is monitored. The study has a~     cross-over design, in which participants will receive their oxygen prescription in two~     different modes at different times during the night. The assignment (sleep vs. continuous~     mode) to which participants will initiate the night will be randomized, and all participants~     will utilize each of the two modes during the study. The hypothesis of this study is that~     there will not be a significant difference in oxygen saturation (SpO2) for participants~     while they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed~     oxygen flow, as compared to their SpO2 while on continuous flow oxygen during sleep during~     the course of the one night sleep study.~   "
105267|NCT01679288|"~     The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA)~     and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general~     practitioner in Primary Health Care.~   "
105268|NCT01679275|"~     Congenital heart disease with need for early surgery in newborns is associated with an~     increased incidence in global impairment in development. The causes of these late adverse~     neurologic outcomes are multifactoral and include both fixed (or patient-specific factors)~     and modifiable factors. They relate to both the mechanism of central nervous system injury~     associated with congenital heart disease and its treatment. Measuring cerebral oxygenation~     is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit.~     The importance of cerebral monitoring in neonates with congenital heart problems at risk of~     developing neurological complications is increasingly recognized. In this way the most~     vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in~     (timing of) treatment.~   "
105269|NCT01679262|"~     There are several studies that have measured various oropharyngeal airway space distances~     using radiological method. However, direct confirmation of optimal size of oropharyneal~     airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The~     purposes of this study were to directly determinate the proper size of OPA in individual by~     FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine~     the relationships among the size of OPA, straight length from the incisors to the tip of the~     epiglottis by laryngoscopy, patient height, and external facial measurements.~   "
105270|NCT01679249|"~     An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration~     (UF) is essential for determining the efficacy of HD, as well as for reducing complications~     related to hypovolemia or, conversely, chronic volume overload.~   "
105271|NCT01679236|"~     A. The study follows a randomized controlled design with approximately 60 smokers with a~     history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention~     to a matched 7-week education intervention to evaluate intervention effect on smoking~     cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness~     intervention will yield statistically significantly higher smoking abstinence than controls~     as measured by carbon monoxide breath test and Time Line Follow Back at at the end of~     treatment (2-weeks post smoking cessation attempt).~   "
105272|NCT01679223|"~     The purpose of this study is to measure the level of AlloMax™ incorporation (cellular~     infiltration, collagen production, and neovascularization) in human breast reconstruction.~     The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast~     capsule at the 3-4 month time point.~   "
105273|NCT01679210|"~     The overall goal of this randomized controlled trial is to test the efficacy of a culturally~     and linguistically modified, individually-tailored lifestyle intervention to reduce risk~     factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with~     a history of abnormal glucose tolerance during pregnancy.~   "
105274|NCT01679197|"~     This study involves research about an investigational medicine called metreleptin. The~     reason for this study is to find out how metreleptin can improve non-alcoholic~     steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare~     disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin~     is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be~     given via injections under the skin. We plan to continue therapy for a period of one year~     and evaluate the change in liver disease by a liver biopsy. We will also follow the~     metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body~     composition characteristics (e.g. the pattern of fat distribution in the body).~   "
105275|NCT01679184|"~     Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior~     to living kidney transplantation and randomize these individuals into a desensitization~     protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after~     treatment and up to 6 months post transplant.~      If desensitization is needed prior to transplantation in individuals with a negative~     crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with~     routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine~     levels) as well as protocol biopsy evaluations.~   "
105292|NCT01678963|"~     The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic~     squalamine lactate eye drops in treating patients with neovascular age-related macular~     degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive,~     irreversible, severe loss of central vision.~   "
105717|NCT01673399|"~     In this study the investigators compare the usual way of embryo transfer (without~     medication) with an embryo transfer while administering oxytocine antagonist. This to~     improve implantation and increase the pregnancy rate.~   "
105276|NCT01679171|"~     Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome~     (e.g. hospital survival) of an ICU stay is improving in this population but little data have~     been published on long-term outcome. Beyond survival, outcome assessment in the elderly~     requires to evaluate several aspects of health: mental status, activity of daily living,~     pain, depression, frailty… referred by geriatrician as comprehensive geriatric assessment'~     (CGA).~      The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients~     mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will~     be performed on the patients' site of living.~      This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.~   "
105277|NCT01679158|"~     The purpose of this study is to evaluate the impact of minor variations in Incisionless~     Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,~     and weight loss in the treatment of primary obesity. It will confirm, in an open prospective~     study, the action mechanisms for the POSE endoscopic treatment technique for obesity, and~     it will help determine if they are maintained at least 6 months following the procedure.~     Durability of weight loss will be tracked through post-POSE visits up to 18 months following~     the procedure.~   "
105278|NCT01679145|"~     The aim of this project is to assess which behavioral and neuroimaging alterations~     associated with reward- based learning predict relapse in alcohol- dependent patients within~     a follow- up period of 12 months.~      The investigators will explore how these alterations interact with clinical and psychosocial~     factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and~     positron emission tomography (PET) will be used to identify neurofunctional abnormalities in~     neurotransmitter systems. The investigators will also provide data for genetic analysis and~     modeling.~      Patients will be detoxified in an inpatient setting and followed for 12 months using the~     Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and~     brain imaging will be carried out within at least 4 half- lives after any psychotropic~     medication.~      The investigators will implement and apply functional imaging paradigms assessing~     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model~     parameters of learning with alcohol craving, intake and prospective relapse risk.~   "
105279|NCT01679132|"~     The BAROSTIM NEO HTN trial is a prospective, randomized, controlled trial to demonstrate the~     safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.~      Currently, the BAROSTIM NEO HTN trial is not actively enrolling. CVRx is conducting~     long-term follow-up of patients implanted with the BAROSTIM NEO device. This update was not~     done for any subject protection concerns that would preclude continuation of the~     investigation.~   "
105280|NCT01679119|"~     The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in~     combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell~     Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based~     chemotherapy.~      There is no standard of care for the treatment of this group of patients. If demonstrated to~     be efficacious and safe to deliver this regimen will be further tested in a phase III trial~     to determine whether this should become the standard of care amongst patients with DLBCL not~     fit for anthracycline (R-CHOP).~   "
105281|NCT01679106|"~     Up to 174 patients undergoing renal transplantation will be randomized to one of two groups.~     Randomization will be based on computer-generated codes using random block sizes ranging~     from 4 to 8.~      Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA~      The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain~     scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged~     analgesic benefit. In addition, the presence of any pain at the incision site will be noted~     at the 1 month surgical follow-up to determine any evidence of chronic pain.~      The investigators hypothesis is that unilateral kidney transplant patients with a continuous~     TAP catheter will have decreased pain scores and opioid usage compared to those receiving~     standard analgesic therapy.~   "
105282|NCT01679093|"~     The purpose of our study is to determine if there is an antagonism between drugs used in the~     prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen~     after thyroidectomy.~   "
105283|NCT01679080|"~     Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are~     fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the~     present study is to investigate the effect of treatment of adult OI patients with~     bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass,~     fracture risk and quality of life.~      The investigators will therefore conduct a double blind, placebo controlled trial, taking~     genotype and previous antiresorptive therapy into account.~   "
105284|NCT01679067|"~     To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected~     people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients~     are more likely to be diagnosed with opportunistic infections, their risk of death is higher~     and their rate of immunological improvement is slower (Mussini C et al., 2008). These~     patients often present a real challenge due to their advanced clinical status (Borghi V et~     al., 2008). Unfortunately, little is known about the clinical presentation of these~     patients, their responses to antiretroviral treatment and especially about the changes in~     the adaptive and innate immunity of the GALT.~   "
105285|NCT01679054|"~     This is a retrospective cost-minimization analysis study to compare the costs of treatment~     with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline~     characteristics and cost data will be extracted from records and compared.~   "
105286|NCT01679041|"~     The purpose of this study is to evaluate the toxicity and the effectiveness of high dose~     chemotherapy with HPC transplant Multiple Sclerosis that has failed at least two lines of~     therapy~   "
105287|NCT01679028|"~     The purpose of this study is to see how safe an investigational new drug (T89) is and how~     well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.~   "
105288|NCT01679015|"~     Evaluating the percentage of patients that suffer from eye allergies and determining whether~     they also have dry eyes.~   "
105289|NCT01679002|"~     To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of~     BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to~     assess the tolerability of such regimens in healthy subjects.~   "
105293|NCT01678950|"~     Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed:~     the MostCare system. This monitoring system is powered by Pressure Recording Analytical~     Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile~     changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal~     recorded invasively in radial, brachial, or femoral arteries. The most innovative features~     of this method are: 1) the lack of a calibration requirement, 2) the analysis of the~     arterial wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is~     unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm.~     The investigators primary end-point was to evaluate the relationship between Cardiac Output~     (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU)~     patients under different clinical conditions. As a secondary end-point the investigators~     evaluated the relationship between CO measured by MostCare with CO obtained with~     thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution,~     i.e. PiCCO system). This is a prospective multicentre observational study.~   "
105294|NCT01678937|"~     This study is being done with the purpose of trying to understand if and why transplant~     recipients may develop tolerance to their transplanted organ. Tolerance means being able to~     lower or take away immunosuppression (anti-rejection medications) without causing organ~     rejection.~   "
105295|NCT01678924|"~     This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia~     (PHN).~   "
105296|NCT01678911|"~     This study is done to investigate the pain relieving effects of the study drug Gralise (a~     novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects~     with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis~     will be recruited. The purpose of this research is to look at how the study drug can be used~     to benefit people who experience this type of pain. This is a phase IV study done to study~     the safety and effectiveness of the drug. At this point the drug has been approved by the~     Food and Drug Administration and has been reported to be well tolerated and effective in the~     treatment of various chronic pain conditions, particularly in neuropathic pain. About 36~     subjects will take part in this study.~   "
105297|NCT01678898|"~     This is the first human treatment with PRX-102, an enzyme being developed as a long-term~     enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha~     galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be~     evaluated in this study of increasing doses. Patients will be treated with infusions every~     two weeks for 12 weeks (7 infusions).~   "
105298|NCT01678885|"~     The purpose of this study is to test different methods of measuring energy balance,~     including food intake and energy expenditure. Another purpose of this study is to see if~     energy expenditure predicts weight and change after a weight loss diet.~   "
105299|NCT01678872|"~     The purpose of this study is to examine the long term safety of an experimental gene~     transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.~   "
105300|NCT01678859|"~     Infertility affects approximately one in six couples1. In approximately one third of cases,~     there is no cause found as to why a couple are unable to conceive2. In order for natural~     pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the~     woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is~     known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus~     and tubes.~      There is evidence that the composition of this mucus in women may affect fertility but this~     area has not been studied well in recent years, partly because fertility treatments such as~     IVF bypass the cervix.~      Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of~     fertile and infertile animals. It appears that the mucus not only helps sperm to get to the~     uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus~     may also help prevent bacteria and infection reaching the womb.~      In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the~     investigators would like to investigate some of the properties of human cervical mucus.The~     investigators propose to do this by taking samples of cervical mucus around the time of~     ovulation and also approximately one week later in fertile women and sub-fertile women. Then~     to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and~     urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.~      The investigators wish to determine if there are differences between the mucus of these~     women and how it may impact on sperm function and on fertility.~   "
105301|NCT01678846|"~     The purpose of this study is to determine whether use of the Good Schools Toolkit is~     effective in reducing violence against children in primary schools.~   "
105302|NCT01678833|"~     Background:~      Although some treatments for substance abuse are considered effective for some people who~     are drug dependent, many others do not benefit as much over time. Researchers are working to~     find out what characteristics predict treatment response. They also want to determine how to~     design treatments that are more effective for a greater number of substance abusers. This~     pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a~     treatment considered to be one of the most effective in reducing substance-abuse, to~     identify ways in which the brain works that may predict and explain treatment effects. A~     comparison group will be included that receives only standard psychotherapy or talk therapy.~     This approach will enable researchers to determine what factors might be interfering with~     favorable treatment outcomes and how to refine or develop new treatments that work well for~     more people.~      Objectives:~      - To identify individual characteristics which predict and explain the effects of CBT in~     people with opiate dependence.~      Eligibility:~        -  Males between 18 and 60 years of age who are dependent on opioids (such as heroin).~        -  Participants must be willing to take buprenorphine and receive substance abuse~          counseling.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Researchers will ask questions about participants ability to cope in certain~          situations, along with questions about drug use and lifestyle issues. These questions~          will be asked twice, before and after completing treatment.~        -  Participants will be placed into one of two groups. One group will have CBT twice a~          week for 8 weeks. The other group will have standard counseling twice per week. Both~          groups will take buprenorphine as part of the drug abuse treatment.~        -  Participants will have other tests during this study. They will have imaging studies to~          look at brain function. These studies will test thinking and decision making.~   "
105303|NCT01678820|"~     The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin~     fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control~     while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks~     of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated~     with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.~   "
109024|NCT01629199|"~     The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF~     (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with~     uncontrolled diabetes mellitus.~   "
105304|NCT01678807|"~     The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]~     and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust~     mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least~     one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house~     dust mite-induced allergic rhinitis/rhinoconjunctivitis.~   "
105305|NCT01678794|"~     To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis~     upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and~     cGMP pathway.~      The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and~     renal dysfunction will improve renal function with increased sodium excretion, glomerular~     filtration rate and effective renal plasma flow and renal function reserve as compared to~     the response of placebo-treated subjects.~   "
105306|NCT01678781|"~     A study to evaluate, by country and overall, the changes from baseline of the irritable~     bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with~     Duspatalin® or Dicetel® in IBS patients.~   "
105307|NCT01678755|"~     This is an efficacy study evaluating a experimental treatment for cognitive deficits in~     adults with schizophrenia.~   "
105308|NCT01678742|"~     The aim of our study is to investigate the effects of high-protein diet on satiety and~     incretin hormones in patients with diabetes.~   "
105309|NCT01678729|"~     To determine the influence of pupil size in refractive surgery. If any influence exist.~   "
105310|NCT01678716|"~     This complex evaluation of a large-scale program uses a cluster-randomized design where 20~     geographic clusters (subdistricts) were randomized to study two sets of interventions. For~     the evaluation of behavior change interventions only, the 20 clusters were randomized to 10~     intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a~     market-based model for delivering micronutrient powders (MNP) along with behavior change~     interventions, there was subsequent randomization to comparison area, MNP-only area,~     Behavior Change Communication (BCC)-only area and MNP+BCC areas.~   "
105311|NCT01678703|"~     This study compares the effectiveness of cervical preparation before second trimester~     abortion using laminaria versus vaginal Misoprostol.~      The investigators hypothesize that medical preparation of the cervix with vaginal~     Misoprostol is superior to mechanical preparation using laminaria.~      The investigators believe that medical preparation makes the procedure easier to perform,~     equally safe, without addition of pain or discomfort.~   "
105312|NCT01678690|"~     Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort),~     to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4)~     administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability~     and safety will also be assessed during this 1-week period.~   "
105313|NCT01678677|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8~     different formulations of investigational NTHI vaccine in current and former smokers, 50-70~     years of age.~   "
105314|NCT01678664|"~     Determine wether 24 months treatment with everolimus prolongs progression free survival rate~     (based on a central assessment) after embolisation ou chemoembolisation for liver~     metastases.~        -  H0 a 24 months progression free survival rate less than 35% is unacceptable~        -  H1 a 24 months progression free survival rate greater than 35% would show that~          everolimus treatment is beneficial, the expected 24 months progression free survival~          rate being 50%~   "
105315|NCT01678651|"~     Different kinetics markers have been proposed to select embryos with higher implantation~     rates. The effect of external factors on these markers, such as the stimulation protocol~     should be analyzed. There are two different types of FSH that are commonly used for in vitro~     fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of~     each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to~     observe if there is a difference in embryo kinetics and morphology as well as oocyte~     morphological parameters between the two types of FSH and therefore to analyze if such~     markers can be used despite of the stimulation protocols chosen.~   "
105316|NCT01678638|"~     The purpose of this study is to determine whether early (before NICU discharge) or late~     (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who~     have an inguinal hernia.~   "
105317|NCT01678625|"~     Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care~     unit when muscle relaxant drugs have been used in the operating room. The only method of~     reliably detecting the presence of neuromuscular blockade is through the use of quantitative~     neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and~     display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio~     of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this~     ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the~     endotracheal tube can be removed. At the present time, there is only one~     commercially-available quantitative monitor available in the United States -the TOF-Watch.~     It is not used by many clinicians because it requires experience to obtain accurate results,~     is expensive, and is subject to interference by factors in the operating room. The aim of~     this investigation is to examine a new quantitative monitor (the T4-EMG (EMG =~     electromyography) that may not be subject to the same limitations as the TOF-Watch AMG (AMG~     = acceleromyography). In order to study the accuracy of this new device, the T4-EMG will be~     compared to the current clinical gold standard, the TOF-Watch.~   "
105318|NCT01678612|"~     Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality.~     Commonly touched items in the patient care environment harbor microorganisms that may~     contribute to HAI risk. The purpose of this study is to assess whether placement of~     copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI~     in comparison with non-copper surfaced objects.~   "
105319|NCT01678599|"~     The purpose of this study is to estimate the gain in sensitivity of several multiple-sample~     strategies of PCR samples with respect to the current standard (single sample of 10 ml) to~     detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based~     on the sensitivity, cost,the completeness of sampling and the acceptability for study~     patients.~   "
109025|NCT01629186|"~     The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique~     may use for support or rescue asphyxiated infants during Flexible bronchoscopy.~   "
105322|NCT01678560|"~     Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to~     the patient in terms of serious co-morbidities and results in a great cost to the VA Health~     Care System to treat the co-morbidities, which include heart disease, stroke and~     neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and~     studies have shown a poor adherence to treatment. The investigators hypothesize that using~     wireless technology will lead to early detection of problems of treatment use and will~     translate into early remedial action which will improve the use and effectiveness of~     treatment. The investigators will compare two methods. Usual care involves downloading data~     from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit.~     Wireless care involved more frequent monitoring and intervention in the event of anomalies~     in treatment use or effectiveness.~   "
105323|NCT01678547|"~     Stroke are the main causes of motor disability among adults and are expected to impose an~     increasing social and economic burden for our Country. The impact of stroke on patients is~     enormous, with negative ramifications on the persons participation in social, vocational,~     and recreational activities. It is the primary cause of long-term disability in these~     countries. At the present stage, it is well known that control of balance during upright~     standing depends upon the central integration of afferent information from vestibular,~     somatosensory (proprioceptive, tactile), and visual systems, which constitute a multilink~     neural network for the control of neck, hip, and ankle joints. More recently, it has been~     studied at the level of cerebral cortex; vestibular inputs would reach face/neck~     representation of primary somatosensory cortex and would be then integrated with visual and~     somatosensory inputs in intraparietal, posterior end of the insula and medial superior~     temporal cortices. Remarkably, balance impairment and the associated risk of falling~     represent one of the most prominent and potentially disabling features in stroke subjects.~     The specific aims of this project are: to verify whether the robotics lower limb treatment~     with body weight support is more effective than the treadmill treatment in the reduction of~     motor impairment in Stroke patients, and to improve the quality of the gait and the~     endurance and to analyze possible improvements in terms of physiological biomechanical gait~     through analysis of spatio-temporal parameters.~   "
105324|NCT01678534|"~     Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind,~     placebo-controlled, with sequential inclusion of patients~   "
105325|NCT01678521|"~     Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional~     pattern-recognition protein, is expressed in many tissues/cells, including innate immunity~     cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert~     protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and~     future cardiovascular risk.~      LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of~     coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the~     procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis~     on plasma PTX3 levels.~   "
105326|NCT01678508|"~     In a population-based study to explore the impact of TPMT-status on the risk of relapse and~     of second cancer among all patients treated according to the NOPHO ALL2000.~   "
105327|NCT01678495|"~     It has proposed the use of ST without microbubble treatment in randomized association with~     both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.)~     associated with MB diagnostic not yet been investigated in a randomized study.~      The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs~     the standard rtPA treatment in a randomized study in consecutive patients with acute~     ischemic stroke.~      We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically~     superior to standard treatment in terms of recanalization rate.~   "
105328|NCT01678482|"~     This is a clinical research study to determine the ability of the Clear device to treat mild~     to moderate inflammatory acne, and to determine if the average person is able to use the~     device properly according to the labeling as describe in the operator manual.~      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in~     which the subjects will be treating themselves with the Clear device, and 2 follow-up visits~     to evaluate the results. The clinical result will be assessed by the investigator for~     improvement in the acne condition. Treatment will be performed on the face of subjects~     enrolled and who meet the inclusion criteria.~   "
105329|NCT01678469|"~     Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance~     with its onset or its first recognition during pregnancy and that usually disappears, at~     least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may~     reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk~     of potentially severe maternal, fetal and neonatal complications (gestational hypertension,~     pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly~     correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic~     beta cells to sustain compensatory insulin secretion for insulin resistance that is~     physiological in pregnancy but can be much more pronounced in some women, especially in case~     of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient~     deficiencies are frequently reported in obese patients. Some nutritional deficiencies,~     concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E,~     carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies~     show an inverse relationship between plasma concentrations and/or dietary intake of these~     micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in~     the pathogenesis of type 2 diabetes through an alteration of insulin secretion and~     sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and~     beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be~     implied in the physiopathology of insulin resistance and glucose intolerance.~      Some case-control studies find an inverse correlation between the plasma concentrations of~     vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and~     of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for~     carotenoids. Besides, the few available studies are mainly descriptive ones, without clear~     explanations on underlying mechanisms. The favourable effects of these micronutrients on~     insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory~     cytokines secreted at the level of the adipose tissue. Numerous studies showed that women~     developing GDM during their pregnancy presented with a significant decrease in the~     circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and~     insulin-sensitizing properties) and a significant increase in the secretion of the~     pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our~     laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human~     adipocytes and in vivo in mice that vitamin E could induce the transcription and the~     secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the~     inflammatory reaction in the adipose tissue, which is involved in the physiopathology of~     insulin resistance.~      Aims and methods We hypothesise that, in pregnant women, there is a link between plasma~     concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and~     carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing~     a GDM; we also hypothesise that this relationship is independent of age, body mass index,~     ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a~     transversal monocentric study, within a population of 500 pregnant women submitted to a~     systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of~     Marseilles.~      The main criterion of evaluation of the link between lipophilic micronutrients and GDM will~     be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E,~     lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient~     is situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points~     in the highest quartile. At the end, each patient will thus have a score between 0 and 21~     reflecting the global status of these micronutrients.~      The main secondary objectives will be to define the relationships between the plasma~     concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and~     insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA~     index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and~     pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.~   "
105330|NCT01678456|"~     Prospective registration and independent assessment of SAE associated with atrial~     fibrillation such as thromboembolic events, and other cardiac and noncardiac complications~     by a Critical Event Committee.~   "
105331|NCT01678443|"~     This phase I trial studies the side effects and best dose of monoclonal antibody therapy~     before stem cell transplant in treating patients with relapsed or refractory lymphoid~     malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal~     antibody BC8, can find cancer cells and carry cancer-killing substances to them without~     harming normal cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be~     an effective treatment for relapsed or refractory lymphoid malignancies.~   "
105332|NCT01678430|"~     The purpose of this study is to compare ofatumumab & chlorambucil (O-Chl) versus ofatumumab~     & bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not~     fit enough for rituximab, fludarabine & cyclophosphamide (R-FC).~   "
105333|NCT01678417|"~     Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of~     less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has~     relatively good prognosis, continual treatment is needed due to frequent relapse. FL with~     histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma.~     Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of~     relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using~     131I-rituximab in refractory or relapsed patients with FL or MCL~   "
105379|NCT01677819|"~     The objectives of this study are to investigate:~        1. the effect of methylphenidate on attention;~        2. the relations between methylphenidate and inhibition control and working memory;~        3. the relations between inhibition control and verbal attention and working memory;~        4. the effect of methylphenidate on the changes of neuropsychological functioning and~          blood pressure.~   "
105334|NCT01678404|"~     Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with~     variable differentiation status, which is distributed to a variety of organs.~      A high response rate and long term survival is possible through surgery or radiation therapy~     alone in the case of limited disease. However frequent relapse and progression is observed~     despite of long term survival. The treatment after relapse has not been established yet.~      So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or~     relapsed patients with MZL.~   "
105335|NCT01678391|"~     To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone~     removal without use of fluoroscopy. Success for this study will be defined as the successful~     removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will~     only be used at the end of a presumed successful procedure to confirm that all stones are~     removed.~   "
105336|NCT01678378|"~     This community-partnered participatory study will work within high school health centers~     (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level~     intervention to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The~     goal of this study is to examine the effectiveness of the School Health Center Healthy~     Adolescent Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the~     SHC clinic environment, and the schools in which the SHCs are located. Evaluation of the~     intervention will involve random assignment of eight comparable SHCs in the Greater Bay Area~     of California that provide comprehensive health services, to either intervention or control~     sites. Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200)~     will be assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20~     weeks follow-up to examine intervention effects on knowledge and self-efficacy regarding~     ARA, harm reduction and ARA-related resources as well as intentions to intervene with peers.~     For youth reporting recent ARA victimization, the investigators will assess for increases in~     ARA disclosure, resource utilization, as well as reduction in ARA victimization.~   "
105337|NCT01678365|"~     A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009.~     Included were children younger than 14 years with Complicated appendicitis randomly assigned~     either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin,~     and Metronidazole. The outcome variables compared were: maximum daily temperatures, overall~     duration of fever, time return to oral intake, length of antibiotic therapy, results of~     repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess~     drainage, Length of stay and adverse reaction.~   "
105338|NCT01678352|"~     This is a pilot study of a vaccination regime that is designed to efficiently induce~     anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with~     BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will~     induce potent anti-glioma immune response with minimal or no toxicity.~   "
105339|NCT01678339|"~     Thi is an observational, non interventional, cohort analysis by using administrative~     databases (drugs treatment, laboratory and diagnostic tests, specialist visits and~     hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute~     Coronary Syndrome (ACS) event.~   "
105340|NCT01678326|"~     The purpose of this study is to prospectively compare the efficacy of endoscopic~     ultrasound-guided biliary interventions (EUS-rendezvous or direct EUS-guided therapy) to~     that of advanced ERCP cannulation techniques in the setting of difficult cannulation. We~     hypothesize that EUS-guided interventions will be more successful and may be associated with~     the same complications as using advanced ERCP techniques in cases of difficult bile duct~     access.~   "
105341|NCT01678313|"~     To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the~     potential predictive value of the absence of prostate cancer in the treatment of patients~     with LUTS/BPH and an elevated serum PSA level.~      Patients who meet all eligible requirements for entry into the study will be randomized into~     one of the two treatment groups for 3 months in 2:1 ratio as shown below:~        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)~        2. Doxazosin 4mg every day (QD)~   "
105342|NCT01678300|"~     The purpose of this protocol is:~        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC~        2. To describe the determinants of medication adherence in patients with UC prescribed~          topical mesalamine~   "
105343|NCT01678287|"~     This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after~     repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy~     adult male and female subjects.~   "
105344|NCT01678274|"~     Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes~     affecting 1 of 2000 live born girls. The syndrome is characterized by an increased~     prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke~     and autoimmune diseases in general.~      Our study aim is:~        -  Using MRI to further characterize and find risk factors leading to aortic dilation.~        -  Using MRI to assess the degree of aortic distensibility.~        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to~          characterize the prevalence and degree of ischemic heart disease and coronary~          anomalies.~        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of~          aortic stiffness when compared to controls using end points as Pulse Wave Velocity,~          Augmentation Index and Central Pulse Pressure.~   "
105345|NCT01678261|"~     The human genetic material consists of 46 chromosomes of which two are sex chromosomes. The~     sex-chromosome from the mother is the X and from the father the Y-chromosome. Hence a male~     consist of one Y and one X chromosome and a female of 2 X-chromosomes. Alterations in the~     number of sex-chromosomes and in particular the X-chromosome is fundamental to the~     development of numerous syndromes such as Turner syndrome (45,X), Klinefelter syndrome~     (47,XXY), triple X syndrome (47,XXX) and double Y syndrome (47,XYY). Despite the obvious~     association between the X-chromosome and disease only one gene has been shown to be of~     significance, namely the short stature homeobox gene (SHOX). Turner syndrome is the most~     well characterized and the typical diseases affecting the syndrome are:~        -  An Increased risk of diseases where one's own immune system reacts against one's own~          body (autoimmune diseases) and where the cause of this is not known; For example~          diabetes and hypothyroidism.~        -  Increased risk of abortion and death in uteri~        -  Underdeveloped ovaries with the inability to produce sex hormones and being infertile.~        -  Congenital malformations of the major arteries and the heart of unknown origin.~        -  Alterations in the development of the brain, especially with respect to the social and~          cognitive dimensions.~        -  Increased incidence obesity, hypertension, diabetes and osteoporosis.~      In healthy women with to normal X-chromosomes, the one of the X-chromosomes is switched off~     (silenced). The X-chromosome which is silenced varies from cell to cell. The silencing is~     controlled by a part of the X-chromosome designated XIC (X-inactivation center). The~     inactivation/silencing of the X-chromosome is initiated by a gene named Xist-gene (the X~     inactivation specific transcript).This gene encodes specific structures so called lincRNAs~     (long intervening specific transcripts) which are very similar to our genetic material (DNA)~     but which is not coding for proteins. The final result is that women are X-chromosome~     mosaics with one X-chromosome from the mother and the other X from the father. However,~     numerous genes on the X-chromosome escape this silencing process by an unknown mechanism.~     Approximately two third of the genes are silenced, 15 % avoid silencing and 20 percent are~     silenced or escape depending on the tissue of origin.~      The aforementioned long non-protein-coding parts of our genetic material (LincRNAs) are~     abundant and produced in large quantities but their wole as respect to health and disease~     need further clarification. Studies indicate that these LincRNAs interact with the protein~     coding part of our genetic material modifying which genes are translated into proteins and~     which are not. During this re-modelling there is left foot prints on the genetic material~     which can indicate if it is a modification that results in silencing or translation of the~     gene. It is possible to map these foot prints along the entire X-chromosome using molecular~     techniques like ChIP (Chromatin immunoprecipitation) and ChIP-seq (deep sequencing).~      The understanding achieved so far as to the interplay between our genetic material and~     disease has arisen from genetic syndromes which as the X-chromosome syndromes are relatively~     frequent and show clear manifestations of disease giving the researcher a possibility to~     identify genetic material linked to the disease. Turner and Klinefelter syndrome are, as the~     remaining sex chromosome syndromes, excellent human disease models and can as such help to~     elaborate on processes contributing to the development of diseases like diabetes,~     hypothyroidism, main artery dilation and ischemic heart disease.~      The purpose of the study is to:~        1. Define the changes in the non-coding part of the X-chromosome.~        2. Identify the transcriptome (non-coding part of the X-chromosome)as respect to the RNA~          generated from the X-chromosome.~        3. Identify changes in the coding and non-coding parts of the X-chromosome which are~          specific in relation to Turner syndrome and which can explain the diseases seen in~          Turner syndrome.~        4. Study tissue affected by disease in order to look for changes in the X-chromosome with~          respect to both the coding and non-coding part of the chromosome.~      6. Determine if certain genes escape X-chromosome silencing and to establish if this is~     associated with the parent of origin.~   "
105346|NCT01678248|"~     to determine the effectivness of intravitreal avastin injection on visual acuity on people~     that suffer from central retinal vein occlusion~   "
105347|NCT01678235|"~     The aim of this study is to determine whether insulin glulisine is more effective in~     postprandial glycemic control than insulin aspart after the H-GI meal in children with type~     1 diabetes (T1DM) treated with insulin pump (CSII).~   "
105390|NCT01677676|"~     This study has been designed to evaluate the safety and immunogenicity of two different~     formulations of FP-01.1 as well as build on the data set from the first in human study~     FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best~     formulation of the vaccine to evaluate in efficacy studies.~   "
106026|NCT01669447|"~     Significant difference in the parameter settings of early optical coherence tomography (OCT~     spectal domain) in patients with subfoveal neovascular membrane realacionada age after~     treatment with a single intravitreal injection of Lucentis.~   "
105348|NCT01678222|"~     Background:~      - The immune system contains several different types of cells in the blood and other parts~     of the body. The body can fight infections well with the right balance of these cell types.~     The wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2~     gene may help decide the balance of cell types that the body makes as part of the immune~     system. It may also play a role in certain immune system diseases. Researchers want to see~     how COX-2 affects the cells in the immune system.~      Objectives:~      - To study how the COX-2 gene works in the body s immune system.~      Eligibility:~      - Individuals 18 years of age and above who are part of the Environmental Polymorphisms~     Registry.~      Design:~        -  Participants will have one study visit at the National Institutes of Health. They will~          collect a urine sample at home on the morning of the study visit.~        -  Participants will have a physical exam and medical history. They will provide a blood~          sample. They will also give researchers the urine sample they collected that morning.~        -  No treatment will be provided as part of this study.~   "
105349|NCT01678209|"~     The growing number of medications used to treat attention-deficit/hyperactivity disorder~     (ADHD) raises important questions about whether different medications have similar or~     different therapeutic mechanisms of action. We have recently shown that the stimulant~     methylphenidate (MPH) and the non-stimulant atomoxetine (ATX) produce clinical improvement~     via a common mechanism in motor cortex, and distinct actions in frontostriatal and midline~     cingulate-precuneus regions. These exciting findings offer a window into the common and~     unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments.~     However, the interpretation and clinical utility of these results would be greatly enhanced~     by in-depth investigation of the impact of the two treatments on relevant neural networks,~     and analyses which evaluate whether improvement is achieved via normalization or other~     adaptive changes in brain function.~   "
105350|NCT01678196|"~     This project begins to evaluate the effectiveness of a web-based family outreach tool that~     is designed to promote treatment engagement among Veterans with posttraumatic stress~     disorder (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental~     health care. The National Center for PTSD has developed an on-line, Veteran-tailored,~     interactive web tool called VA - Community Reinforcement and Family Training (VA-CRAFT) that~     trains family members to effectively help their Veterans to engage in treatment for PTSD~     and/or AUDs. This project will provide preliminary information about VA-CRAFT's~     effectiveness.~   "
105351|NCT01678183|"~     This study is a pilot study. The investigators have designed a randomized, controlled trial~     of financial incentives in medication adherence, focusing primarily on poorly-controlled~     diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that~     many patients do not take their medications as prescribed by their doctors. This contributes~     to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and~     death. The investigators hypothesize that use of a financial incentive will motivate~     patients to improve their medication adherence and ultimately their control of their chronic~     diseases.~      The investigators plan to identify patients who get Primary Care at Boston Medical Center~     who still have high blood sugars more than a year after their diabetes diagnosis, and~     randomize them to a control arm, or one of two intervention arms. Subjects will be~     approached at the time of a regularly-scheduled appointment with their Primary Care doctor~     and offered the opportunity to participate in the study. All subjects who agree to~     participate in the study will meet with a Clinical Pharmacologist to review their~     medications in detail, and then undergo randomization. Subjects in the first intervention~     group will receive a cash incentive for picking up medications for the targeted conditions~     from the pharmacy each month. Subjects in the second intervention group will receive a cash~     incentive for picking up medications for the targeted conditions from the pharmacy each~     month, and a one-time payment at the conclusion of the study based on the amount of~     hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study,~     and anticipate an observational cohort of approximately 1,000 patients.~      All patients who are eligible for the study but who are not enrolled in the study and have~     not declined to participate in the study will become the observational cohort for the study.~     The observational cohort will be used to determine whether randomization to the control arm~     of the study has a negative, rather than neutral, effect on patients.~      At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to~     have their blood pressure checked and to have their blood drawn so that their blood sugar~     and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid~     panel, systolic blood pressure, diastolic blood pressure, self-reported health,~     microvascular and macrovascular complications, and death.~   "
105352|NCT01678170|"~     This trial is going to evaluate the value of blood-oxygen functional imaging technology in~     the diagnosis of breast diseases.~   "
105353|NCT01678157|"~     The objective of this study is to examine the safety and efficacy of porcine acellular~     dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of~     laparoscopic large paraesophageal hernia repair.~   "
105354|NCT01678144|"~     The purpose of the trial is to demonstrate the safety, performance and implantability of the~     Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial~     aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty~     rings.~   "
105355|NCT01678131|"~     This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of~     liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards~     identifying a minimally invasive, reproducible platform to measure liver PK. The study will~     be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core~     needle biopsy (CNB) time-point collection sequences. In Part 2, participants will be~     randomized to one of two possible doses of vaniprevir and will be assigned to one of five~     FNA/CNB time-point collection sequences; participants in Part 2 will also receive background~     therapy with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The~     primary hypothesis is that there is a greater than 80% posterior probability that vaniprevir~     concentrations are successfully obtained at least 60% of the time from FNA liver samples~     collected at 2 of 3 specified timepoints.~   "
105356|NCT01678118|"~     Patient navigators have been shown to assist people seeking cancer screening and other~     medical services. The purpose of this study is to see whether a patient navigator can link~     smokers to available community resources shown to help smokers quit smoking.~   "
105357|NCT01678105|"~     This is a non-randomized, phase II, open label study of dovitinib in patients with~     progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose~     of this study is to assess the anti-cancer effects of dovitinib in this population in order~     to evaluate whether dovitinib is worthy of further study in patients with progressive ACC.~   "
105358|NCT01678092|"~     A phase 1 single center study in which omalizumab is dosed normally (according to the~     product insert) in subjects with atopic dermatitis.~   "
105419|NCT01677299|"~     This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes~     mellitus.~      In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating~     concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes~     mellitus.~   "
105359|NCT01678079|"~     This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,~     Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,~     1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests,~     one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium~     and the other with a micronutrient supplement powder containing encapsulated calcium at the~     same dose. The absorption tests will be separated by a 2-week washout period. Fractional~     calcium absorption will be measured using the dual stable isotope method. For each test, the~     formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable~     isotope will be given orally and a 42Ca-labeled stable isotope dose will be given~     intravenously. Urine will be collected for 48 hours to measure calcium absorption.~   "
105360|NCT01678066|"~     Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate~     information when placed on a patient's Right or Left side.~      Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac~     output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The~     FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the~     manufacturer in pediatric and adult patients with leads placed on the left side. However,~     sometimes the surgical site and/or patient position precludes placement of the monitor leads~     on the left side. In such situations it would be useful to know whether placement of the~     monitor's leads on a patient's right side gives accurate cardiac output data. We will~     prospectively collect, and compare, simultaneous physiologic data for all enrolled children~     using two monitors, one on the patient's right side and one on the patient's left side.~   "
105361|NCT01678053|"~     Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise~     in the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing,~     hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are~     recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection~     into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but~     causes significant voice loss, occasional difficulty swallowing and, in our clinical~     experience, is associated with significant recurrence. The investigators propose injecting~     another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to~     maintain the benefit of injection with less loss of voice. The investigators have shown the~     effectiveness of this treatment in a small, retrospective analysis.~   "
105362|NCT01678040|"~     One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right~     ventricular (RV) volumes. There are a number of congenital heart defects and acquired~     conditions in which management decisions are fundamentally based on ventricular volumes. The~     gold standard for assessment of RV volume is CMR. It has better near-field resolution than~     echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable~     to the irregular geometry of the RV. The objectives of this study are (1) to assess~     ventricular volumes in the fasting state and after oral hydration in order to assess the~     effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect~     of hydration on ventricular volumes compared the effect of with inter-observer and~     intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber~     deformation, including strain and peak strain rate. This study hypothesizes that (1)~     hydration status has an effect on right and left heart volumes, measured by CMR in healthy~     volunteers; (2) the effect of volume status will be a more significant contributor to~     variability in RV volumetry than that of inter-observer variability and intra-observer~     variability, and; (3) atrial and Ventricular deformation corrected for chamber size or~     volume is more accurate than when uncorrected for volume.~   "
105363|NCT01678027|"~     Helicobacter pylori infection is associated with gastric cancer in epidemiological studies.~     However, it is still unknown whether H. pylori eradication is useful and required to prevent~     gastric cancer.~      Gastric cancer risk is increased in family members of gastric cancer patient. Though there~     is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family~     members of gastric cancer, current European guideline recommends H. pylori eradication in~     first-degree relatives of gastric cancer patients.~      In this study, the investigators will evaluate whether H. pylori eradication can reduce~     gastric cancer risk in the first-degree family members of gastric cancer patients.~   "
105364|NCT01678014|"~     Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and~     young adult women. There are many methods in the treatment of AN, such as family therapy,~     cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are~     refractory to all current medical treatment and never fully recover and the standardized~     mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia,~     stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and~     capsulotomy are the most used methods which has been proved effective in obsessive and~     compulsive disorders, depression and other psychiatric disorders. Many case reports indicate~     that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there~     are some common pathways between AN and other psychiatric disorder. The investigators have a~     hypothesis that deep brain stimulation and capsulotomy may be promising methods in the~     treatment of AN.~   "
105365|NCT01678001|"~     The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of~     the foot.~      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.~      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical~     treatment modalities. Surgical treatment of plantar fasciitis is indicated only if~     nonsurgical means fail.~      A newer method of treating plantar fasciitis before resorting to surgery is the use of~     Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis~     with Xeomin is important, as there are limited studies on the subject to date. The purpose~     of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis~     in one physician's (J.A.) practice at Rothman Institute Orthopaedics through a~     placebo-controlled, randomized, double-blinded study.~   "
105476|NCT01676558|"~     Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in~     Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use~     aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status,~     refractoriness, and relapsed disease still remains. So we investigate the efficacy of~     radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.~   "
105366|NCT01677988|"~     This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research~     study is to determine the safety and effectiveness of modified Folfirinox and radiation~     therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening~     tests will be done to determine if subjects are eligible for participation in this study. If~     subjects are eligible to participate and agree to participate they will begin chemotherapy.~     After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of~     completing radiation therapy, subjects will have surgery. There will also be post-treatment~     and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after~     their initial registration.~   "
105367|NCT01677975|"~     The goal with this study is to evaluate the value of dynamic lymphscintigraphy and~     ultrasoundscanning preoperative in patients with melanomas.~   "
105368|NCT01677962|"~     The main purpose of this study is to examine the safety of the study drug in patients with~     locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know~     about any side effects a patient may have when given the study drug. Another goal of the~     study is to determine if combining dendritic cells and the study drug can be possibly used~     as a vaccine for this disease. Dendritic cells are cells that are present in the body's~     immune system that help your body fight disease.~   "
105369|NCT01677949|"~     Study Design:~      This is a two-stage Phase II trial investigating the efficacy of Clofarabine,~     Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual~     disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the~     study treatment in eliminating the presence of minimal residual disease without causing a~     significant delay of allo-HCT due to treatment related toxicity. The intent of this study is~     to allow patients to proceed to transplant (independent of this study) within 42 days of Day~     1 of Clofarabine based therapy.~   "
105370|NCT01677936|"~     The objective of this study is to compare the effects of Raisins three times per day versus~     alternative snacks three times per day on blood sugar control and cardiovascular risk~     factors (weight, waist circumference, blood pressure, cholesterol levels) in patients with~     Type 2 Diabetes Mellitus. These effects will be studied over a 12 week period.~   "
105371|NCT01677923|"~     The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and~     increases insulin sensitivity; the study team hope to get better effect of weight decrease~     and metabolic processes repair in the intensive treatment group with intervention of~     physical activity, diet correction and Metformin use.~   "
105372|NCT01677910|"~     The primary objective of the study is to confirm that at least 1 or more doses of~     telotristat etiprate compared to placebo is effective in reducing the number of daily bowel~     movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment~     Period) of the trial in patients not adequately controlled by current SSA therapy.~   "
105373|NCT01677897|"~     The purpose of this study is to assess the impact of the addition of metformin to~     abiraterone on survival in patients with metastatic prostate cancer~   "
105374|NCT01677884|"~     The purpose of the study is to assessed the efficiency of treatment based on the objective~     response rate (RECIST 1.1)~   "
105375|NCT01677871|"~     During the Study:~        -  Subject is required to visit every week for the first 2 months and then every month~          till completion of study or as and when required~        -  The usual symptomatic and supportive treatment of Chronic Liver Disease, including use~          of antiviral, will be given to all patients.~        -  Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular~          Treatment.~        -  Liver function tests (LFT) will be done weekly during first 2 months then at one month~          interval or as when required.~        -  The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of~          clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.~          Patients not improving at 4 weeks after initiation of treatment will be shifted to~          alternative regimens and will be excluded from the study.~   "
105376|NCT01677858|"~     This is a Phase 1/2, multicenter, single-arm, nonrandomized, open-label and dose-escalation~     study of weekly carfilzomib and dexamethasone (Cd-qw) for patients with progressive multiple~     myeloma. The Phase 1 dose escalation portion will enroll patients into sequential~     dose-escalating cohorts consisting of 3 patients each to establish the maximum tolerated~     dose (MTD) of carfilzomib administered weekly as a 30 minute intravenous (IV) infusion with~     dexamethasone. The Phase 2 portion will enroll patients using the MTD established for~     carfilzomib from the Phase 1 portion of the study. Dexamethasone will be administered IV or~     PO at the same dose and schedule as used in the Phase 1 portion of the study.~   "
105377|NCT01677845|"~     The aim of this study is to determine the maximum tolerated dose of hypo-fractionated~     radiation therapy and the toxicity of the treatment program.~      Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this~     phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT).~     Dose escalation will be as follows:~      There will be 3 cohorts consisting of 3 patients each.~   "
105378|NCT01677832|"~     Children and adolescents with ADHD are impulsive and have difficulties in regulating their~     behaviors. It has been suggested that a core deficit in inhibitory control may account for~     dysfunctional behaviors associated with this disorder. Previous research has shown that~     medication and the self-regulation strategy of making implementation intentions (i.e.,~     if-then plans) are effective in enhancing children's inhibitory control, which is reflected~     in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on~     a Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming~     implementation intentions may have different effects on people who are embedded in different~     cultures.~      The aim of the present study is to compare the effects of medication and the self-regulation~     of forming implementation intentions by assessing the behavioral performance and~     corresponding brain activity during a Go/NoGo task in children and adolescents with and~     without ADHD under two different cultural contexts. Further, this study also aims at~     investigating the potential moderating effects of culture on making if-then plans. More~     important, as we know, this will be the first study to compare the effectiveness of forming~     implementation intentions on children and adolescents with ADHD in a cross-cultural way,~     which is meaningful for researchers to explore the degree of its application and expected to~     provide clinical psychologists an alternative perspective for ADHD treatment in the near~     future.~   "
105380|NCT01677806|"~     Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom~     medical management has not been successful or for those who are at risk for developing~     complications due to long-term immobilization. Recently, three randomized controlled trials~     (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham~     control intervention failed to show an advantage of vertebroplasty over placebo for~     participants with acute, subacute, and chronic fractures or severe pain. In the third RCT,~     PVP compared to optimal conservative treatment showed significant immediate postoperative~     pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these~     issues, this study is initiated to compare PVP with conservative therapy in patients with~     osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP~     increases the incidence of new compression fractures in adjacent vertebrae.~   "
105381|NCT01677793|"~     Magnetic resonance imaging (MRI) is a premier modality to investigate structures and~     functions of human brain. In studies of children and adolescents, noninvasiveness of MRI~     makes it especially applicable. Developmental trajectory of gray matter volume and cortical~     thickness has been well studied in western countries. However, significant variability of~     brain structure has been reported between Chinese and Caucasian, and the variation may also~     exist in developmental trajectory of the brain. However, the maturation processes of neural~     fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has~     been frequently used to investigate the integrity of fibertracts in the literature, is~     limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly~     developed technique to improve the resolution of crossing fibers, and it is more suitable~     for detailed tractography assessment. In addition to establishing the template of brain~     structure (T1 and T2) and structural connectivity of our child, adolescent, and young adult~     population, the study has the following three aims.~        1. To describe gender effect and developmental change of brain volume of different~          cortical and subcortical regions, thickness of cortex brain, and structural~          connectivity (e.g., frono-striatal, fronto-pareital, fronto-temporal and~          fronto-cerebeller tracts and superior longitudinal fasciculus II) across childhood~          through adolescent to adulthood;~        2. To examine the gender effects and developmental change of attention, executive function~          and visual memory from childhood to adulthood and whether gender moderates these~          developmental changes; and~        3. To correlate the structural connectivity and brain size and neuropsychological function~          within the same subjects.~   "
105382|NCT01677780|"~     This open-label, extension study is designed to provide continuing treatment with RO5045337~     to participants who have completed parent studies NO21279 (NCT00623870), NO21280~     (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).~     Participants are eligible to participate in this study if they have completed required Phase~     1 study assessments for primary objectives of respective parent protocol and are having~     evidence of clinical benefit (as defined by the parent protocol). Participants will continue~     the most similar dose and formulation available (which does not exceed the maximum tolerated~     dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and~     the same schedule of RO5045337 treatment that they were receiving at the time of~     transitioning from the parent clinical study protocol.~   "
105383|NCT01677767|"~     This observational study will evaluate the use in clinical practice and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis~     receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be~     followed for 24 weeks.~   "
105384|NCT01677754|"~     This phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     study will evaluate the efficacy and safety of RO4602522 in patients with moderate severity~     Alzheimer disease. Patients who are taking background therapy of acetylcholinesterase~     inhibitors alone or in combination with memantine for at least 4 months before screening~     will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.~   "
105385|NCT01677741|"~     This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral~     dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive~     solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2~     (tumor-specific expansion study) dose and regimen using a dose-escalation procedure.~     Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose~     of 3 mg/kg and dose will deescalate or escalate between 1.5 milligram (mg)/kilogram (kg) and~     6 mg/kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of~     subjects at the current dose level, the number of subjects who have experienced a dose~     limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but~     with data pending at the current dose level. Escalation may proceed until either a maximum~     tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic~     parameters consistent with exposure in adults are achieved. Cohorts may be added in order to~     evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of~     subjects with tumors known to have BRAF V600 activation (pediatric low-grade gliomas,~     pediatric high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as~     melanoma and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10~     subjects with a pre-dose and at least 1 post-dose disease assessment. In both the parts of~     the study, on Day 1, a single first dose will be administered, and repeat dosing will begin~     on Day 2. PK sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight.~     For subjects <25 kg and >=10 kg in weight, blood samples for PK analysis will be collected~     on Day 1 and Day 15. For subjects <10kg in weight, blood samples for PK analysis will be~     collected after repeated administration on Day 15 only. Safety and tolerability will be~     assessed throughout the study. Treatment with dabrafenib will be continued until disease~     progression or until no clinical benefit or development of an unacceptable toxicity, or~     until they withdraw consent or begin a new therapy. At the end of treatment, a final study~     visit will occur.~   "
105386|NCT01677728|"~     The aim of this study is to explore whether target therapy in combination with chemotherapy~     as treatment could improve survival or tumor response in patients undergoing Synchronic~     Hepatectomy for Colorectal Liver Metastases.~   "
105387|NCT01677715|"~     Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on~     Immunity and Physical Intestinal Canal~   "
105388|NCT01677702|"~     The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective~     in reducing the occurrence of flu symptoms.~   "
105389|NCT01677689|"~     Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue~     cyanobacterium with patented freeze-thaw lysis and extraction method. According to the~     preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral~     ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause~     illness, paralysis and even death, especially in children and elderly people. This phase II~     study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in~     subjects with seasonal influenza.~   "
105391|NCT01677663|"~     Autism or autism spectrum disorder (ASD) is a relatively common (0.3% in Taiwan),~     multi-factorial, genetically and clinically heterogeneous, childhood-onset~     neurodevelopmental disorder. Due to its high heritability and severe long-term impairment~     without available laboratory diagnosis, effective prevention or treatment, this disastrous~     disease has been prioritized for molecular genetic studies. Recent CNVs investigation to~     identify rare variants and GWA study with endophenotype approaches are promising strategies~     to identify common genetic variants. In addition to intermediate phenotypes such as head~     circumstance, speech delay, social impairments and stereotyped behaviors, evidence has~     demonstrated that neuropsychology and neuroimages may be useful endophenotypes for autism.~     Dlgap2, Fbxo25, and Arhgef10 knoutout mice generated from our previous CNV results will be~     characterized.~   "
105392|NCT01677650|"~     The overall objective is to develop a patient oriented research program to efficiently~     evaluate the effects of pharmacogenetic variants on the dose-response relationships and~     safety of opioids and non-opioid analgesics. If an opioid regimen can be created that~     produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid~     concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e.,~     gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may~     decrease preoperative opioid requirements can be more efficiently and safely evaluated.~     These interventions may limit the opioid related toxicities related to effect site~     concentrations that are below those required when opioids are the predominant analgesic,~     such as opioid related ileus. Methadone's slow elimination clearance and limited~     pharmacokinetic drug-drug interactions make it an attractive perioperative opioid. The first~     step towards personalized opioid analgesia is to determine the effect of common~     pharmacogenetic variants that affect either methadone metabolism (CYP2B6) or opioid~     elimination.~   "
105393|NCT01677637|"~     Osteoporosis is the most common disease of bone and characterized firstly by low bone mass~     and secondly, impaired bone microarchitecture structure resulting in reduced strength and~     increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal~     Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common~     form is postmenopausal osteoporosis. It occurs in women after menopause and is associated~     with decreased estrogen production, which normally occurs at this age women Osteoporosis~     usually occurs after age 50, it is very common in women than in men, and its frequency~     increases with advancing age.~   "
105394|NCT01677624|"~     To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in~     Japanese subjects with hypervascular tumor or arteriovenous malformation~   "
105395|NCT01677611|"~     Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes~     and a constituent of red wine, is associated with longevity likely through the increased~     production of a protein, SIRT1.~      The trial is a proof-of-concept study primarily designed to examine for the first time in~     humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10~     patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary~     outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure,~     physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber~     type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and~     insulin sensitivity.~   "
105396|NCT01677598|"~     The purpose of this study is to determine how patients use ustekinumab (label-recommended or~     other/missed dose interval) in Asia-Pacific countries.~   "
105397|NCT01677585|"~     The purpose of this study is to compile real-world clinical outcomes data for the PROMUS~     Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element~     and PROMUS Element Plus Stent System) in routine clinical practice in China.~   "
105398|NCT01677572|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with~     prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to~     assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18~     (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose~     serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after~     multiple dose administration in this population.~   "
105399|NCT01677559|"~     This phase I trial studies the side effects and the best dose of MLN8237 (alisertib) when~     given together with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)~     in treating patients with solid malignancies that are metastatic or cannot be removed by~     surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as nab-paclitaxel work by killing the~     cells or by stopping them from dividing. Giving alisertib together with nab-paclitaxel may~     provide a more effective anticancer treatment with fewer side effects.~   "
105400|NCT01677546|"~     Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.~     Together with wireless communication with blood glucose meter potentially facilitates~     achieving the target post prandial glucose levels. In this RCT authors assessed whether use~     of wireless communication between compatible devices: MiniMed insulin pump and blood glucose~     meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is~     the impact of exerting this tool on metabolic control in type 1 diabetic patients.~   "
105401|NCT01677533|"~     The PROVE aims to test the efficacy of panel management support and educational intervention~     in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive~     methods for implementing panel management strategies among health care providers in VA~     primary care clinics: providing only panel data, providing panel management support, and~     providing support plus clinical microsystem-enhancing education and training.It is~     hypothesized that the group receiving panel management and educational interventions will~     have better smoking cessation and hypertension outcomes than the group receiving only panel~     management assistance. It is further supposed that the later will have better smoking~     cessation and hypertension patient outcomes than the data-only group.~   "
105477|NCT01676545|"~     (A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in Chinese (Shanghai))~   "
111123|NCT01601743|"~     The purpose of this study is to test the effects of exercise on cocaine use, fitness, and~     cravings for cocaine and nicotine. This study is part of an effort to develop treatments for~     cocaine abuse.~   "
105402|NCT01677520|"~     The overall purpose of this study is to enhance identification and isolation of ADSCs and~     adipocytes, to find the optimum culturing conditions to increase growth and volume of~     grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections~     are used in aesthetic surgery but tend to disassemble over time. If the investigators can~     enhance growth and volume of fat in culture, the investigators could use fat grafts in~     reconstruction of cancer and traumatic injury defects with the patients own cultured fat~     cells and grafts.~   "
105403|NCT01677507|"~     Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to~     medications is a critical barrier for the clinician to consistently provide highly effective~     IOP-based treatments. Current trial-and error approaches to glaucoma management are~     inefficient and have not addressed this barrier as there are no predictive factors for drug~     response. Our long-term goal is to improve outcomes by identifying biomarkers and~     environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of~     disease progression, poor response to treatment, and large IOP fluctuation. Our purpose of~     this research project is to address this critical barrier by focusing on physiological~     factors that predict IOP response to drugs.~   "
105404|NCT01677494|"~     Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement~     imaging), biology (markers of collagen turn-over) and proteomics~   "
105405|NCT01677481|"~     The study compares radiation exposure parameters between coronary angiography procedures~     performed by left wrist, right wrist or groin (femoral) procedure access site~   "
105406|NCT01677468|"~     The aim of this study was to evaluate whether survival of patients who underwent TACE with~     unresectable HCC can benefit from intermediate-levels of embolization.~   "
105407|NCT01677455|"~     The purpose of this study is to determine if ganetespib (STA-9090) is effective in the~     treatment of patients with HER2+ or triple negative breast cancer who have not received~     prior systemic treatment in the metastatic setting.~   "
105408|NCT01677442|"~     The purpose of this study is to compare results of general Video-assisted Thoracic Surgery~     (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a~     control group operated under general anesthesia with double-lumen endotracheal intubation.~   "
105409|NCT01677429|"~     Hypotheses~      The investigators hypothesize that among individuals who suffer from panic disorder there is~     higher incidence of co-morbid balance impairment than in the healthy population.~      The investigators hypothesize that the treatment of panic disorder, through the treatment of~     co-morbid balance impairment using virtual reality (VR) exposure therapy environment, is~     more effective than the exposure to still pictures from the same scene in VR without balance~     challenge or comparing to standard cognitive behavioral therapy (CBT) for the treatment of~     panic disorder.~      Rationale~      This research relies on previous studies, which have shown mutuality between anxiety and~     balance impairment, even if only sub-clinical. The VR-based training environment enables~     multi-sensorial stimulus in a dynamic interactively changing setting. With the addition of a~     cognitive task (dual task distracting the fear), the investigators can add cognitive load~     and therefore challenge the control of balance even more. Individuals who suffer from~     balance impairment avoid their exposure to many balance-challenging situations - a fact that~     may increase their anxiety. The investigators assume that a considerable number of PD~     individuals also experience balance control impairments - mostly subclinical ones. Moreover,~     balance impairment accompanies other psychiatric disorders, though not enough literature~     exists on the subject.~   "
105410|NCT01677416|"~     Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of~     patients with rheumatoid arthritis (RA) and normal controls, determine the association~     between ultrasound and global disease activity, function and goniometric measures in~     patients with RA and determine the correlation between ultrasound and radiography in the~     detection of bone erosion.~      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,~     calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50~     healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated~     bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power~     Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.~   "
105411|NCT01677403|"~     This is a study to evaluate the efficacy,indications,adverse reactions and resistance of~     combined administration of nebulized tobramycin compared with systemic administration alone~     in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.~   "
105412|NCT01677390|"~     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of~     SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell~     carcinoma.~   "
105413|NCT01677377|"~     Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages~     of risperidone with clinically stable schizophrenia~   "
105414|NCT01677364|"~     Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were~     randomised into elective induction and spontaneous labour groups only after bishop score was~     equal to or more than 6.It was concluded that induction of labour with oxytocin is a~     relatively safe procedure in women with low risk heart disease with NYHA class I and II. It~     resulted in a similar caesarean delivery rate and was not associated with more maternal and~     neonatal complications.~   "
105415|NCT01677351|"~     Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant~     therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular~     and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic~     effect of clonidine and its repercussion on arterial and intraocular pressure and~     arrhythmias for cataract surgery.~   "
105416|NCT01677338|"~     This study is a multi-center, open-label comparison study and aimed to evaluate the~     preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying~     abnormal (delayed) gastric emptying rates in subjects.~   "
105417|NCT01677325|"~     To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a~     Chinese herb formula.~   "
105418|NCT01677312|"~     This study compares the 19G and 25G needles for procuring tissue samples from the pancreas~     during Endoscopic Ultrasound (EUS) procedures.~   "
105548|NCT01675622|"~     The efficacy of dose titration of OxyNorm™ immediate-release capsules versus morphine~     immediate-release tablets in the treatment of cancer pain.~   "
105420|NCT01677286|"~     The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's~     disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and~     immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If~     untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of~     patients.~      This single-center, twelve-month, open-label, prospective, pilot phase II study aims to~     determine whether doxycycline reduces amyloid deposits and improves organ function in~     patients with systemic or localized amyloidosis.~      The investigators plan to enroll patients with measurable amyloid disease according to~     internationally-accepted diagnostic criteria. Patients must have stable organ function at~     enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting~     their kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s),~     lungs, eyes, skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and~     12 months - or more frequently as clinically indicated.~      Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The~     investigators will use standard grading systems to assess doxycycline response following~     twelve months of treatment.~   "
105421|NCT01677273|"~     The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact~     casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,~     to study the effects on appetite regulation assessed by subjective appetite sensations, ad~     libitum energy intake and appetite regulating hormones.~      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and~     casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion~     rates approaches the rates of whey. In the present study the importance of absorption rate~     and amino acid composition, in regards to energy expenditure and appetite regulation, will~     be examined. HC and IC have identical amino acid composition, but differ in absorption rate,~     whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We~     hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend~     that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,~     whereas IC will be more satiating after several hours.~      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in~     a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI~     27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein~     supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or~     IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained~     over 24 hours and appetite will be assessed by visual analogue scales and appetite~     regulating hormones. Furthermore, ad libitum energy intake will be assessed.~   "
105422|NCT01677260|"~     This was a single centre, single-blind, randomized, balanced, combined single dose study~     under fasting condition and multiple doses study under fed condition with normal~     diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability~     of metformin hydrochloride 500 mg extended release caplet (test drug) and metformin~     hydrochloride 500 mg prolonged release tablet (reference formulation).~   "
105423|NCT01677247|"~     This was a randomized, single blind, two-period, two sequence cross-over study under fasting~     condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test~     and reference formulations).~   "
105424|NCT01677234|"~     Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This~     cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a~     cesarean delivery frequently causes the patient to shiver and their arm to shake, and~     sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist~     may be more effective when a patient is shivering because their lower arm moves less and can~     be more easily stabilized. We will be taking simultaneous blood pressure measurements both~     just before and during cesarean deliveries in order to compare blood pressure at the upper~     arm versus the wrist.~   "
105425|NCT01677221|"~     This prospective, open-label study will be conducted in 15 healthy subjects per clinical~     site ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to~     5 lesions treated on the face, chest or back with the Acleara insert. Subjects will receive~     up to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any~     adverse events.~   "
105426|NCT01677208|"~     The purpose of this study is to determine whether Danhong injection is effective in the~     treatment of acute ischemic stroke.~   "
105427|NCT01677195|"~     The primary purpose of the study is to evaluate the effectiveness of a naturally occurring~     clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen)~     and fumonisin (a cancer promoter). This clay substance contains of a variety of minerals~     including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate~     minerals have been regularly used as dietary supplements by humans and animals, and the~     safety of this naturally occurring clay substance has been tested in clinical trials. The~     FDA treats such minerals or nutritional supplements as a drug when tested for potential of~     lessening the likelihood of disease (i.e., potential for mitigating disease).~      This study involves the use of an investigational drug called Hydrated Sodium Calcium~     Aluminosilicate (ACCS100). Investigational means that the drug has not yet been approved~     by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure~     in humans.~   "
105428|NCT01677182|"~     To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated~     with Bipolar 1 Disorder.~   "
105429|NCT01677169|"~     The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)~     and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in~     peripheral blood lymphocytes of cigarette smokers.~   "
105430|NCT01677156|"~     The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of~     Corus® CAD in Real World Clinical Care Settings (PRESET)--was designed as an observational,~     post-market, real-world registry to evaluate patterns of care, including referrals to a~     cardiologist, cardiac stress testing, CT angio, within the first month after Cours CAD~     testing.~   "
105549|NCT01675609|"~     The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate~     0.025% ophthalmic solution used four times daily in a population of adult and geriatric~     subjects~   "
105550|NCT01675596|"~     The objective of the study is to observe the safety, efficacy and cost effectiveness of the~     Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.~   "
105431|NCT01677143|"~     Pre-emptive local anaesthetics are widely used in laparoscopic surgery, but there is no~     really consistent evidence that it is useful. Studies in the literature have shown~     contradicting results. At our hospital we are currently using pre-emptive local anaesthetics~     in the trocar areas, but as the literature does not give a clear and clinically relevant~     answer, we need to find out more. This study aims to see if pre-emptive local anaesthetics~     are useful in the setting of our day-case, laparoscopic surgery.~   "
105432|NCT01677130|"~     The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea~     and refractory hypoxemia caused by various reasons. Although in recent years a variety of~     supportive care measures have significant progress, but the mortality rate of patients with~     ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with~     ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can~     improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS~     usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion~     has heterogeneity. The protective mechanical ventilation strategies chosen by patients with~     ARDS in clinical practice are gradually being accepted and applied. The High-frequency~     oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal~     volume. Compared with conventional mechanical ventilation, HFOV may be able to more~     effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and~     protective ventilation strategy in ARDS is consistent with an important position in the~     treatment of ARDS, but not been widely adopted in clinical practice and is still only as a~     salvage treatment. Therefore, this study intends to use HFOV treatment with conventional~     mechanical ventilation by matching the cases in patients with ARDS. By comparing the~     influences of the patient's condition and mortality with HFOV, the clinical efficacy,~     safety, and health economics effectiveness of HFOV are further investigated and adaption~     time and parameter settings of HFOV are explored, which provide better treatment options for~     patients with ARDS and improve their prognosis.~   "
105433|NCT01677117|"~     Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality~     rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the~     main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to~     improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical~     ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been~     challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians~     have more choices in the face of hypoxemia, and with the deepening understanding of ECMO,~     ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been~     recognized by the majority of medical workers. Therefore, we assume that accurately grasping~     the ECMO indications and standardizing the implementation of treatment can significantly~     improve the prognosis, shorter hospital stays, lower hospitalization costs.~   "
105434|NCT01677104|"~     Incretins have become a successful drug target in the repertoire of medications used for the~     treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on~     the vascular system in humans, independent of their glucose lowering actions and data are~     only derived from ex vivo studies in animals. Particularly little is known about clinically~     relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with~     type 2 diabetes.~      The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown~     product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The~     investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the~     beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be~     produced by the body.~      The study aims to examine the response of GLP-1 and its analogues on small blood vessels and~     examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese~     individuals and subjects with Type 2 diabetes.~   "
105435|NCT01677091|"~     The main objective of this study is to test the effectiveness of a rehabilitation program~     with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.~   "
105436|NCT01677078|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was~     shown to be effective in the treatment of major depression.~      The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the~     standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference.~     Nevertheless, it has been criticized due to poor targeting accuracies attributed to~     inter-subject variability.~      Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.~      Preliminary findings suggest that a more reproductible and accurate method, based upon a~     neuronavigation system could allow for a better efficacy. This finding has to be replicated~     with sound methodology.~      Investigator's objective is to compare efficacy on mood of coil positioning based upon a~     neuronavigation device versus coil positioning based upon the standard method.~   "
105437|NCT01677065|"~     To determine whether the bioavailability of the controlled-release test formulation is at~     least as high as that for the commercial reference drug.~   "
105438|NCT01677052|"~     The primary purpose of this registry is to obtain real world clinical use of contact force~     measurements during ablation procedures.~   "
105439|NCT01677039|"~     The study is designed to test whether or not the rate and extent of absorption of oxycodone~     from a proprietary controlled-release formulation is significantly affected by~     co-administration of alcohol compared with controlled conditions (when the formulation is~     administered with water). The primary pharmacokinetic parameters are the peak concentration~     of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area~     under the plasma concentration-time curve (AUC).~   "
105440|NCT01677026|"~     The primary objectives of the Registry are to:~        1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical~          performance to a larger number of centers in the post market phase and~        2. Collect additional evidence to support reimbursement and clinical acceptance and long~          term follow up~   "
105441|NCT01677013|"~     The study is aimed to evaluate the safety and efficiency of autologous bone marrow~     mononuclear cell transplantation in treating selective patients with type 2 Diabetes~     Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would~     promote β-cells regeneration by directly differentiated from the transplanted BMMCs or~     stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous~     insulin and improve β-cells function.~   "
105442|NCT01677000|"~     Establish an international registry of over 400 patients with deep infections involving the~     bone and/or joint from≥20 centers representing all regions of the world with varied hospital~     and surgeon practice settings to ensure that registry analyses and research reflect typical~     clinical practice thereby providing optimal guidance for patients, clinicians, and~     healthcare researchers. Using a data collection platform that minimizes entry burden,~     collects most information at the time of surgery, and uses Internet technology to minimize~     data entry. The registry will include:~        1. baseline patient attributes;~        2. surgical approach, implants and technology;~        3. hospital course;~        4. surgeon and institutional characteristics;~        5. longitudinal patient outcome,~        6. post-procedure complications and revisions,~        7. serum/tissue/drainage samples.~   "
105443|NCT01676987|"~     To evaluate the efficacy and safety of a fixed-dose, single-capsule~     budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both~     delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was~     Randomized, double-blind, multicenter, phase III, parallel clinical trial.~   "
105444|NCT01676974|"~     Objectives: Prospectively study the influence of foreign travel and associated risk factors~     on the acquisition of AMR in the endogenous microbiota of healthy individuals and the~     subsequent persistence of AMR carriage and transmission to household members of these~     carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of~     bacterial infections in the year after travel (compared to non-carriers). Explore the full~     width of AMR genes and transferable genetic elements acquired during international travel.~   "
105445|NCT01676961|"~     This phase II trial studies how well romiplostim works in increasing low platelet counts in~     patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to~     make platelets after chemotherapy~   "
105446|NCT01676948|"~     This two-part open-label, multi-arm, non-comparative study will collect long-term safety,~     efficacy and tolerability data from patients who were responsive to canakinumab from study~     CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort~     2). In addition, the effect of inactivated vaccines in an SJIA patient population will be~     assessed for the development of adequate (protective) antibody levels following immunization~     according to respective local vaccination guidelines.~      Study Part I:~      All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4~     weeks for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end~     unless discontinuation occurs, or until they qualify for Part II of the study.~      Study Part II:~      Patients who are eligible will be randomized to receive canakinumab at a reduced dose or~     prolonged dose interval (see requirements for dose reduction/dose interval prolongation~     below).~      Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but~     will be part of the treatment arm canakinumab dose reduction if they are eligible.~   "
105447|NCT01676935|"~     This is a long term extension study to evaluate safety and tolerability of subjects who~     complete study M10-985 which is evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease.~   "
105448|NCT01676922|"~     This observational study will evaluate the use of Avastin (bevacizumab) and conventional~     chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal~     cancer. Data will be collected from each patient from initiation of treatment until disease~     progression occurs (minimum follow-up 12 months).~   "
105449|NCT01676909|"~     Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress~     Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting~     in increased risk of disability, high health care spending, reduced quality of life and~     early mortality. Physical wellness is increasingly recognized as a key component of the VA's~     commitment to developing recovery-oriented and Veteran-centered mental health treatment.~     There is also growing recognition of the value of interventions that promote and improve~     patient self-management of chronic medical conditions. Building on the established efficacy~     of consumer facilitated medical illness self-management programming used in the general~     population and two recent adaptations for use with SMI adults in the public health sector~     (including the investigators' own evaluation of an intervention called Living Well), the~     investigators propose to complete a randomized controlled effectiveness trial of the Living~     Well intervention and simultaneously conduct a well specified process evaluation to optimize~     knowledge accrual regarding important factors that may improve future adoption,~     implementation and sustainability of the Living Well intervention in the VA system of care.~   "
105450|NCT01676896|"~     Asthma is the most common chronic childhood illness and disproportionately affects children~     who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with~     children who live in rural areas or have included Mexican American children in their~     samples. This study builds on the original R01NR007770 with findings that demonstrated the~     intervention could improve children's asthma self-management, asthma knowledge, metered dose~     inhaler skill, asthma severity, and parents' asthma management and access to care. In this~     competing continuation, the investigators added a third arm to the current research design~     with schools randomized into either an in-school asthma intervention, an in-school~     attention-control intervention, or an alternate intervention-delivery format of a single~     5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American,~     African-American, and White rural school-aged children (grades 2-5) who have asthma and~     their parents. In addition, the investigators propose adding a non-invasive measure of~     chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma~     management on airway inflammation. Families will be followed for a full year with data~     collection at baseline and at 1-month, 4-months, and 7-months after the intervention to~     assess improvement in children's asthma morbidity, asthma severity, airway inflammation,~     family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop~     group and the School-Home group will demonstrate equivalent improvements, but greater~     improvements than the Attention-Control group in:(H1.1) their asthma severity and airway~     inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office~     visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time~     4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms~     will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the~     pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to~     the Attention-Control group.~   "
105451|NCT01676883|"~     Studies have confirmed the association between plantar callosities and severely obese~     individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for~     estimating body composition because it is easy to use, noninvasive, relatively inexpensive,~     and can be performed across a wide range of subjects.~      Our hypotheses for this study are: (1)plantar callosities influence the body composition~     measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates~     the percentage of body fat compared with air-displacement plethysmography (BodPod).~   "
111124|NCT01601730|"~     The purpose of this study is to improve the efficacy of modafinil as a potential treatment~     for cocaine dependence.~   "
105452|NCT01676870|"~     The primary objective of the study is to compare in a real-world setting the efficacy of~     traditional training (today's guideline, vigorously or moderate exercise) and amount of~     aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic~     syndrome.~      The secondary objective is to compare the efficacy of traditional moderate training (today's~     guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic~     capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle~     energy metabolism, left ventricle systolic and diastolic function at rest and right~     ventricular function.~      The investigators hypothesized that aerobic interval training would reverse features of the~     metabolic syndrome more than traditional training.~   "
105453|NCT01676857|"~     The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of~     chronic pelvic pain syndrome in men.~   "
105454|NCT01676844|"~     There is a deficit in the number of 'age-appropriate' formulations available for the~     delivery of medicines to children. Liquid preparations are considered the 'gold standard'~     for delivering medicines to children however many of these are formulated using ingredients~     which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal~     babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function~     of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in~     the saliva, releasing the active ingredient(s) without the need for chewing or water, making~     them ideally suited to patients who find it difficult to swallow other oral dosage forms~     such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a~     safe and effective alternative for oral administration of phosphate supplements to neonatal~     infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is~     hypothesised that this treatment will be equal to standard therapy using an oral solution.~     Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate~     as soon as they have been established on oral feeds in order to prevent bone disorders such~     as osteopenia. Babies recruited to this study will be given phosphate supplementation as per~     NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take~     place in the intensive care and special care baby units at the Princess Royal Maternity in~     Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels~     (obtained from routine sampling only) to evaluate treatment effect. Babies will be~     randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks~     followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment~     will be equivalent to standard oral solution.~   "
105455|NCT01676831|"~     The objective of this study is to explore the safety and the preliminary efficacy of two~     concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA)~     Cutaneous T Cell Lymphoma patients.~      This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products~     Development, FDA.~   "
105456|NCT01676818|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin~     mesylate, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing~   "
105457|NCT01676805|"~     Background:~      - Lab studies help researchers better understand cancer biology. This information may lead~     to new methods for diagnosing or treating cancer. To develop these studies, researchers want~     to collect samples from people with cancer or precancer conditions of the lymph system.~     These conditions include multiple myeloma, different types of lymphoma, and adult~     leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor~     and skin tissue.~      Objectives:~      - To collect tissue samples to study different types of lymph cancer.~      Eligibility:~      - Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Different samples will be collected for study. Blood samples will be collected at the~          initial testing. More blood samples will be collected at different treatment points.~          Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue~          and skin tissue biopsies will also be collected for study.~        -  Treatment will not be provided as part of this study.~   "
105458|NCT01676792|"~     This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in~     Solanum undatum plant extract) in patients with VIN(s) or EGW(s).~   "
105459|NCT01676779|"~     This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with~     AJCC stage IIIB/C & -IV melanoma. At baseline tumor assessment (using total body~     FDG-PET/CT), patients should be free from measurable tumor lesions (according to RECISTv1.1~     definitions) following prior local therapy (e.g. following surgical resection, isolated limb~     perfusion, radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …).~     Patients should not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or~     pleural effusion), and lesions treated by prior local therapy should be free from~     progression. Patients should not have received any prior systemic therapy (non-experimental~     or experimental).~   "
105460|NCT01676766|"~     The purpose of this study is to utilize flavoprotein fluorescence and fundus~     autofluorescence to detect progression of Stargardt macular dystrophy in a pediatric~     population over the course of a year with the hope of aiding future therapeutic risk-benefit~     decisions and assessment of outcomes.~      Stargardt macular dystrophy is the most common of the juvenile-onset macular dystrophies.~     Despite determination of ABCA4 as the causative gene, clinicians have been challenged by~     variability in clinical phenotypes. Given the recent initiation of clinical trials to assess~     novel treatments (e.g. gene therapy), there is a need to identify patients with the worst~     prognosis.~      The investigators have observed that pediatric patients lose central visual function faster~     than their adult counterparts. Thus, they present an ideal cohort with which to determine~     the utility of novel modalities to detect early change. These include flavoprotein~     fluorescence, a new imaging technique for detecting mitochondrial dysfunction developed at~     the University of Michigan. Fundus autofluorescence (FAF) is another commonly utilized~     technique of evaluating hereditary eye diseases. The investigators have developed a novel~     means of quantifying FAF signatures that will allow documentation of severity as well as~     detection of progression.~   "
105461|NCT01676753|"~     The purpose of this trial is to determine the safety and tolerability (maximum tolerated~     dose (MTD)) of weekly dinaciclib in combination with every 3 week pembrolizumab in patients~     with advanced breast cancer. Once this is defined, a 20 patient dose expansion will be~     performed at this MTD in patients with metastatic or locally advanced and unresectable~     triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and~     pembrolizumab.~   "
105462|NCT01676740|"~     To establish the efficacy of screening for anemia and treatment of mild anemia with iron and~     vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative~     allogeneic blood transfusion.~   "
105463|NCT01676727|"~     This study is intended to collect data regarding the clinical utility, safety and~     performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation~     (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via~     direct aortic access (DA) is selected. As part of the study analysis, resource utilization~     together with the Quality of Life questionnaires data will provide an important input into~     cost effectiveness analysis.~   "
105464|NCT01676714|"~     The purpose of this study is to find out if dovitinib is an effective treatment for patients~     with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on~     anti-vascular endothelial growth factor (VEGF) treatment.~   "
105465|NCT01676701|"~     The purpose of this study is to evaluate the serum concentration of tabalumab after the~     administration using either prefilled syringe or auto-injector after the initial loading~     dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional~     safety extension.~   "
105466|NCT01676688|"~     The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at~     home or in out-of hospital locations.~   "
105467|NCT01676675|"~     Influenza is an acute respiratory infection caused by influenza virus with high incidence~     and serious complications even causing death. According to the announcement released by the~     World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2~     billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus~     may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious~     adverse consequences for human health and social welfare worldwide.~      From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to~     Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has~     attracted the WHO and national government great attention. So it is meaningful to develop~     vaccine to provide effective antibody to reduce the number of infections.~      The objective of this study is to evaluate the safety and preliminary immunogenicity of a~     whole virus inactivated influenza H5N1 vaccine.~   "
105468|NCT01676662|"~     The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace~     Bladder Control System is safe and effective for the treatment of Stress Urinary~     Incontinence (SUI) in adult females.~   "
105469|NCT01676649|"~     The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two~     different dosing schedules will be investigated in patients with metastatic melanoma. This~     protocol will also investigate both the clinical benefit of this combination and the~     features of the host immune system that may predict response to ipilimumab with chemotherapy~     in patients with unresectable Stage III and Stage IV melanoma.~   "
105470|NCT01676636|"~     The SickKids-led research team is currently developing a prenatal micronutrient powder that~     will contain calcium, iron, and folic acid with different absorption characteristics. Once~     the powder is developed, it can be incorporated into various oral delivery vehicles. The~     overall effectiveness of a micronutrient program is highly dependent on the acceptance and~     regular consumption of supplements (i.e., adherence) by the targeted users. This is a study~     of the preference, acceptability, and palatability of 4 alternative delivery vehicles for~     the innovative prenatal multiple micronutrient supplement: traditional tablets, oral~     disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder~     with a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study~     hypothesizes that that the formulation of the delivery vehicle will impact preference,~     acceptability, and palatability.~   "
105471|NCT01676623|"~     Alive & Thrive is an initiative that aims to improve infant and young child feeding~     practices and reduce childhood stunting. In Vietnam, Alive & Thrive's primary intervention~     is implemented through a social franchise linked with the government's health system. The~     impact evaluation is conducted using a cluster-randomized design in which 20 commune health~     centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to~     routine government services. Repeated cross-sectional baseline and endline surveys will be~     used to assess the public health impact of this intervention. The baseline was in 2010 and~     an endline survey in the same communities will be conducted in 2014. Mixed methods process~     evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the~     program impact is achieved.~   "
105472|NCT01676610|"~     Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important~     sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a~     rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin~     oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the~     clinical setting. In this research study, we propose to test the hypothesis that the use of~     pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is~     useful and feasible for the identification of the infants most urgently in need of medical~     care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health~     centers in Karachi. Infants will undergo brief clinical assessment by a community health~     worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness~     (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician.~     The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to~     obtain measurement, number of infants for who repeat measurements are required), and~     concordance between paired measurements on separate devices.~   "
105473|NCT01676597|"~     -  The study will be a prospective open labelled double blinded randomized controlled~          study.~        -  The study will be conducted on patients admitted to Department of Hepatology from 2012~          to 2014 at Institute of Liver and Biliary Sciences, New Delhi~        -  Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be~          started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.~        -  Patients not responding to this therapy will be given divided into 2 arms with one arm~          receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.~   "
105474|NCT01676584|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.~     Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135~     or placebo subcutaneously.~   "
105475|NCT01676571|"~     The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu~     AA21004 (Vortioxetine) in the Chinese population.~   "
105478|NCT01676532|"~     This is a prospective cross sectional study to assess the feasibility of a school based~     health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in~     Toronto. The SBHC allows inner-city children who face barriers to accessing health care the~     opportunity to receive health care in their school.The primary aim of this study is to~     determine utilization of the SBHC. Establishing feasibility of the SBHC would support~     further development and expansion of this program into other inner city schools.~   "
105479|NCT01676519|"~     Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary~     intervention (PCI) in whom development of critical limb ischemia was prospectively assessed~     by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary~     endpoint of the study.~   "
105480|NCT01676506|"~     Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis)~     treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).~   "
105481|NCT01676493|"~     This is a multicenter, open-label study to evaluate the safety and PK of oral codeine~     sulfate in pediatric subjects with mild to moderate post-procedural pain.~   "
105482|NCT01676480|"~     The purpose of the present study is to investigate if endurance training can be used as a~     therapeutic action against the adverse metabolic disturbances and unfavourable changes in~     body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate~     cancer patients.~   "
105483|NCT01676467|"~     This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers~     and normal healthy subjects, to compare the biological markers of disease and inflammation.~   "
105484|NCT01676454|"~     The purpose of this study is to determine if vasopressin is used up by the body during~     traumatic shock (severe low blood pressure due to trauma).~   "
105485|NCT01676441|"~     This phase II/III clinical trial is designed to evaluate the safety and efficacy of~     autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.~   "
105486|NCT01676428|"~     This is a proof of concept study, to assess the feasibility of introducing a novel~     high-precision radiotherapy technique called stereotactic radiosurgery (SRS) or~     stereotactic body radiotherapy (SBRT) for the treatment of kidney cancers in Australia.~     This study aims to invite 20 patients with renal cell carcinoma and 10 patients with~     isolated adrenal metastases from non-small cell carcinoma who are either medically~     inoperable, high risk for surgery, or decline surgery to participate. In cohort of patients~     with renal cell carcinoma, both patients with primary disease only, and those patients who~     have limited metastases (≤5) will be eligible. Besides technical feasibility of delivering~     this treatment, this study will be to assess efficacy, toxicity and tumour response using a~     novel imaging biomarker called diffusion weighted-MRI.~   "
105487|NCT01676415|"~     The purpose of this study is to determine the most effective route to administer steroids to~     patients with chronic sinusitis, specifically a type of chronic sinusitis not associated~     with nasal polyps (CRSsNP). The investigators would like to better understand whether orally~     administered steroids results in superior results when compared with nasally sprayed~     steroids. The investigators propose to test the hypothesis that for patients with~     radiographically proven CRSsNP, routine medical therapy consisting of a short course of~     systemic corticosteroids is superior to topical corticosteroids for relieving inflammation~     and the symptoms of CRS.~   "
105488|NCT01676402|"~     This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety,~     tolerability, and immunogenicity of same season and sequential season vaccination schedules~     consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent~     influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The~     hypothesis is that evaluation of these investigational schedules will inform development of~     novel influenza vaccine strategies that may offer improved and cross-protective immunity~     against antigenically diverse influenza strains.~   "
105489|NCT01676389|"~     The purpose of this study is to determine how osteopathic manual medicine (OMM) will affect~     core autism features including social and communication deficits. The investigators believe~     that OMM approaches can positively influence some features associated with Autism/Autism~     Spectrum Disorder (ASD).~   "
105490|NCT01676376|"~     Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate~     feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an~     external vein support device for use over saphenous vein grafts during coronary artery~     bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh~     (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study~     subject will receive one SVG with the eSVS Mesh.~   "
105491|NCT01676363|"~     Diflunisal is an anti-inflammatory drug (like ASA or ibuprofen) that has been used as a~     painkiller for 20 years. Recent research shows that it may have an anti-HIV effect in the~     laboratory. Approximately 20 HIV-infected adults who are not receiving antiretroviral~     therapy will be given diflunisal by mouth twice daily for 4 weeks, at a dose that has been~     shown to be safe when used to treat pain. Subjects will be monitored closely for safety and~     will have frequent blood tests during the study to see if the drug has any effect on the~     level of HIV in their blood.~   "
105492|NCT01676350|"~     By doing this study, the investigators hope to learn whether patients with difficult to~     obtain IV access who are treated with IO access are more satisfied with their care and have~     better outcomes. The investigators are specifically studying the time difference between~     groups and the difference in the number of attempts required to obtain vascular access and~     begin to treat with fluids and medications. The study will also measure patient satisfaction~     and procedural pain, the frequency of central line placement, the length of stay in the~     hospital and emergency department, and adverse events to intravascular access to determine~     whether IO access can improve these measures.~      The investigators hypothesize that the use of a protocol utilizing an IO device for select~     patients with failed IV access will reduce the time requirements to obtain vascular access,~     reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no~     negative impact on patient satisfaction compared to the current ED practices.~   "
105493|NCT01676337|"~     This project proposes administer and evaluate via a randomized controlled trail a text~     message-based appointment reminder system to promote attendance at clinic appointments after~     ED discharge.~   "
105494|NCT01676324|"~     Hypothesis:~      Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with~     Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to~     colonoscopy in the management of patients with Inflammatory Bowel Disease.~      Objectives:~      By means of a survey from the ordering physician we would assess:~      Primary Endpoint~      1. The Percentage of time that the Fecal Calprotectin result caused the physician to change~     the management of a patient.~      Secondary Endpoints~        1. To determine if the Fecal Calprotectin result influenced the number of endoscopies~          performed~        2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when~          endoscopy was performed.~        3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured~          by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if~          endoscopy was performed).~   "
105495|NCT01676311|"~     We will explore the use of Huperzine A in patients who have sustained a moderate to severe~     Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo,~     would have an effect on memory function after TBI. Additionally, we aim to determine whether~     use of Huperzine A in these patients can change brain activity (as indexed by EEG and~     Transcranial Magnetic Stimulation - TMS), and reduce prevalence/frequency of post-traumatic~     seizures. We also aim to evaluate the safety of Huperzine A in this population as compared~     with placebo.~   "
105496|NCT01676298|"~     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a~     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3~     and *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the~     study is to evaluate the performance of the FRX System under multivariate conditions~     including different days, sites, operators and systems.~   "
105497|NCT01676285|"~     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with~     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset~     of complications in liver disease. The purpose of this prospective, randomized trial is to~     determine whether metoprolol succinate can revert cardiac dysfunction secondary to cirrhosis~     (cirrhotic cardiomyopathy), and prevent complications (renal dysfunction, mortality). A~     total of 100 patients with cirrhotic cardiomyopathy will be randomized (Group R) to receive~     metoprolol succinate or placebo; other 25 patients without cirrhotic cardiomyopathy (Group~     F) will only be followed up without medication. All patients will be evaluated in the~     beginning and again after six months. The assessment protocol includes clinical evaluation,~     electrocardiogram, echocardiogram, laboratory analysis and life quality questionaire. The~     end points will be cardiac remodeling, electrophysiologic changes, sympathetic activity,~     laboratory issue changes, renal function, quality of life, and mortality.~   "
105498|NCT01676272|"~     Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,~     data comparing one type of modality to another are scarce. This investigation is a~     prospective randomized study comparing a bioengineered skin substitute to a human skin~     allograft.~   "
105499|NCT01676259|"~     In this Phase II study a single dose 2.8 mg (eight 0.35 mg siG12D-LODERs) will be~     administered to patients with unresectable locally advanced pancreatic cancer combined with~     chemotherapy treatment.~      Primary Outcome:~      - Progression-free survival (PFS) in the study population.~   "
105500|NCT01676246|"~     Flupirtine is metabolized in-vitro via carbamate cleavage and N acetylation to glucuronides~     and mercapturic acid derivatives. The formation of reactive, toxic intermediate products may~     be influenced by genetic polymorphisms of the involved conjugative metabolic pathways. So~     the purpose of this study is to measure pharmacokinetics, metabolism and analgesic effects~     of flupirtine in dependence on the function of NAT2, UGT1A1 and GSTP1.~   "
105501|NCT01676233|"~     Primary Objective:~      - To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a~     new formulation of insulin glargine and Lantus at steady state~      Secondary Objectives:~        -  To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose~          (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;~        -  To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters~          (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));~        -  To compare the occurrence of hypoglycemia between the 2 treatments;~        -  To assess the safety and tolerability of a new formulation of insulin glargine.~   "
105502|NCT01676220|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants~     with type 2 diabetes mellitus~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of:~      - occurrence of nocturnal hypoglycemia~   "
105503|NCT01676207|"~     In contrast to the extensively studied coronary collateral circulation within the heart,~     clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses.~     Usually this has been in the form of case reports giving account of angiographically visible~     anastomoses between the coronary circulation and the internal mammary artery (IMA),~     typically in the presence of a chronic occlusion of a coronary artery. In the anatomical~     literature,the most common types of extracardiac anastomoses include~     bronchial-to-coronary-artery and IMA-to-coronary-artery connections. Anastomoses between the~     IMA and the coronary circulation have been documented to occur in 12% of post-mortem~     patients with CAD.~      Importantly, hitherto existing observations typically have relied on visual methods~     insensitive for the adequate detection especially of structurally present but poorly~     functional anastomoses. On a diagnostic coronary angiogram, collaterals are visible only if~     the recipient vessel is subtotally stenotic or fully occluded, or can be rendered visible~     during coronary spasm or by temporary balloon occlusion of the recipient artery and~     simultaneous injection of contrast medium into the other arteries, respectively. Similarly,~     the macroscopic pathologic postmortem examination is likely to underestimate the true number~     of extracardiac coronary collaterals.~      The purpose of this study is to determine the in vivo prevalence and functional distribution~     of IMA-to-coronary collateral supply via both the right and the left coronary artery.~   "
105551|NCT01675583|"~     The purpose of this study is to investigate the efficacy of an optical device designed and~     developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized~     that the blood flow velocity of the wound site will provide critical information on the~     efficacy of hyperbaric oxygen therapy.~   "
105504|NCT01676194|"~     The hope to treat more patients with hepatocellular carcinoma successfully is however~     tempered by the shortage of donors leading to an increasing waiting time for liver~     transplantation (LT). Intention-to-treat analysis have showed that the reported excellent~     long-term outcome is curtailed and significantly hampered by the growing incidence of~     patients who must be removed from the waiting list because of tumor progression. A way to~     face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic~     options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most~     common modality used. While there are many studies concerning TACE in this setting, none are~     controlled studies and thus there is no firm evidence concerning its efficacy in reducing~     drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial~     complications…) while waiting for LT. Most of the available data have been based upon~     analysis of patients who received a transplant and have not included patients who were~     eligible for LT but died, or showed progression, before it could be performed. Therefore,~     studies conducted on an intention-to-treat basis are needed to clarify the benefit and the~     risks of TACE prior to LT in patients with hepatocellular carcinoma.~   "
105505|NCT01676181|"~     Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in~     treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.~   "
105506|NCT01676168|"~     Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.~   "
105507|NCT01676155|"~     To compare the serum apoptosis-associated markers between patients with active TB and~     patients with LTBI To evaluate the efficiency of apoptosis-associated markers to~     differentiate potential of active TB from LTBI~   "
105508|NCT01676142|"~     1. To compare TLR-2 expression of peripheral blood mononuclear cells and serum downstream~          cytokines in those with MAC or MAB pulmonary infection and those with MAC or MAB~          pulmonary colonization and controls.~        2. To investigate the response of TLR-2 expression and cytokines activation to NTM~          stimulation test in patients with MAC or MAB pulmonary infection and colonization and~          controls.~        3. To validate the NTM stimulation test for NTM pulmonary infection.~   "
105509|NCT01676129|"~     The purpose of this study is to measure the effect of nocipoint therapy on patients with~     temporomandibular joint disorders (TMD) and compare it with the effect of standard~     electrical stimulation therapy.~   "
105510|NCT01676116|"~     This trial is conducted in Europe, Oceania and the United States of America (USA).~      The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in~     controlling glycaemia in adults with type 2 diabetes inadequately controlled on~     glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.~   "
105511|NCT01676103|"~     The objective of this experiment is:~        -  Primary: To determine the effects of tyrosine supplementation on orthostatic~          hypotension in people with PD.~        -  Secondary: To determine the effects of tyrosine supplementation in people with PD with~          autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise~          stress.~      Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who~     suffer from PD, especially as it leads to lightheadedness and falling. For those affected,~     it can drastically reduce quality of life. It has been hypothesized that tyrosine may impact~     upon individuals suffering from PD. There is ample evidence in animal models that supports~     our theory; however there is no clinical evidence of the impact tyrosine supplementation may~     have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses.~     Positive findings that supplemental tyrosine increases BP and HR in people with PD during~     daily activities such as standing up from a chair and walking can lead to new therapies to~     improve Parkinsonian orthostatic hypotension.~      Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine~     therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve~     after tyrosine supplementation.~   "
105512|NCT01676090|"~     To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like~     growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex~     and pubertal stage of a healthy paediatric Spanish population.~   "
105513|NCT01676077|"~     The Clinical Outcome Study for Dysferlinopathy is being performed in centres in Europe~     (UK- Newcastle; Spain- Barcelona, Sevilla; Germany- Berlin, Munich; Italy- Padova; France-~     Paris, Marseille), USA (Charlotte, NC; Columbus, OH; Washington, DC; St.Louis, MO, Stanford~     CA), Japan (Tokyo) and Australia (Sydney). Oversight and funding for this study is being~     provided by the Jain Foundation, a non-profit foundation dedicated to finding therapies for~     dysferlinopathies(LGMD2b/Miyoshi). The aim of this Clinical Outcome Study is to determine~     the clinical outcome measures required for future clinical trials, characterize the disease~     progression of dysferlinopathy and collect biological samples for the identification of~     disease markers that are needed to non-invasively monitor the disease during clinical~     trials. Without this information, effective clinical trials cannot be performed.~      This study is recruiting a large number of genetically confirmed dysferlinopathy patients~     aged 10 years or older, who are ambulant or non-ambulant. Participants will be assessed at 6~     visits over 3 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard~     blood tests. Optionally, the participants can donate blood samples and a skin sample for use~     in the identification of disease markers and other approved research.~   "
105514|NCT01676064|"~     The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients~     undergoing laparoscopic hysterectomy at different time points and body positions throughout~     the procedure, and to explore the influence of perioperative fluid management on the~     fluctuations of IOP during perioperative period.~   "
105515|NCT01676051|"~     The purposes of this study are to identify the common bacterial flora on the hand and~     evaluate the efficacy of readily available skin-preparation solutions in the elimination of~     bacterial pathogens from the surgical site following skin preparation. The null hypothesis~     is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in~     pre-operative skin preparation in clean, elective hand surgery cases.~   "
105552|NCT01675570|"~     The primary purpose of this study is to assess the efficacy, tolerability and safety of~     RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.~   "
105553|NCT01675557|"~     The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses~     to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney~     Disease subjects requiring chronic hemodialysis.~   "
105516|NCT01676038|"~     The success of total knee arthroplasty depends on a number of factors including~     pre-operative range of movement, obesity, medical comorbidities, prosthesis design,~     preparation and implantation of the prosthesis, soft tissue balancing, as well as implants~     alignment. Optimal placement of the implants within 3° of the mechanical axis of the lower~     limb has been proven to reduce wear and early implant failure.~      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has~     been widely used in the last decade and have been proven to improve the accuracy of~     prosthesis placement and lower limb alignment by reducing the number of outliers with more~     than 3° deviation from the mechanical axis. However, its use also involves a steep learning~     curve, high initial capital cost and longer duration of surgery.~      Traditional computer-navigated TKA using optical tracking systems also requires fixation of~     the femoral and tibial reference arrays to bone using anchoring pins. Complications reported~     with the use of these pins include either femoral or tibial fracture, pin site pain, pin~     site infection and osteomyelitis. The investigators study aims to investigate the accuracy~     of a new pinless navigation system for TKA that will avoid these complications.~   "
105517|NCT01676025|"~     The purpose of this study is to compare two surgical methods of adrenalectomy. One is called~     PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at~     patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through~     patient's abdominal cavity after making 3 or 4 holes in the abdomen.~   "
105518|NCT01676012|"~     Through technological improvement a new technique has become available in the form of~     high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the~     standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers~     only. The impact of this development with high-definition videobronchoscopy using a 1.1~     megapixel chip on the diagnostic performance of bronchoscopy is however unknown.~      The aim of the present study therefore is to explore the diagnostic performance (sensitivity~     and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering~     technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode~     SAFE3000 autofluorescence videobronchoscopy in a high risk population.~   "
105519|NCT01675999|"~     In patients with locally advanced colon cancer (high risk stage II and stage III), curative~     surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However,~     for 30-40% of these patients, the current curative treatment strategy of surgical excision~     followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate~     distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an~     attractive concept for locally advanced colon cancer and has the potential to impact upon~     both of these causes of failure. Optimum systemic therapy at the earliest possible~     opportunity may be more effective at eradicating distant metastases than the same treatment~     given after the delay and immunological stress of surgery. Added to this, shrinking the~     primary tumor before surgery may reduce the risk of incomplete surgical excision, and the~     risk of tumor cell shedding during surgery.~      ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response~     rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone~     and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon~     cancer. Control arm includes patients for whom standard treatment comprises surgery followed~     by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a~     neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most~     effective in terms of response rate.~   "
105520|NCT01675986|"~     The insertion of long-lasting intravenous device is done under local anesthesia. Currently,~     in the investigators hospital, no premedication is given to the patients. However, this~     procedure occurs in a particular emotional context related to the diagnosis of cancer or~     malign hemopathies.~      Therefore, administration of a sedative or anxiolytic drugs before the start of the~     procedure can be questionable.~      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and~     anti-histaminic properties A new agent, pregabalin, shares also the same properties~      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine~     on the anxiety score as a premedication during the insertion of long-lasting intravenous~     device under local anesthesia.~   "
105521|NCT01675973|"~     The purpose of this study is to assess the effect of severe renal impairment on the~     steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects~     with normal renal function.~   "
105522|NCT01675960|"~     This study is a prospective, randomized, double blind, placebo controlled, crossover~     clinical trial looking at whether gabapentin can provide symptom relief for chronic~     irritability in neurologically impaired children. The investigators hypothesize gabapentin~     ins beneficial and safe for children with chronic irritability that persists despite~     identification and appropriate management of symptom sources.~   "
105523|NCT01675947|"~     This study will seek to enroll 50 persons who have central or non-central geographic atrophy~     (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be~     between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to~     receive one of the following treatments in the study eye:~        1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or~        2. A sham treatment (subconjunctival injection of lidocaine) Participants with two (2)~          eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and~          no sham in the fellow eye.~      The first injection will begin at Day 0, which may occur on the date of screening/enrollment~     or up to two weeks following screening/enrollment visit, and every month thereafter. The~     visit schedule is as follows:~        1. A clinical evaluation, including safety measures, will occur monthly.~        2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and~          24 months after the first injection has occurred.~        3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24~          months after the first injection has occurred.~        4. Fundus color photography and optical coherence tomography will occur at~          screening/enrollment and at 6, 12, 18 and 24 months after the first injection has~          occurred.~      The primary goal is to evaluate whether the persons receiving the sirolimus injections show~     a slower worsening of geographic atrophy compared to the persons receiving the sham~     injections. A secondary goal is to evaluate the impact of sirolimus on vision compared to~     the sham.~      NOTE: As of May 30, 2014, study injections were discontinued due to safety concerns. No~     further enrollments will occur and follow-up will continue on all active study participants~     on a quarterly basis. That is, on visits coinciding with 3 month intervals from date of~     enrollment.~   "
105554|NCT01675544|"~     Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between~     admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with~     acute heart failure can identify patients at risk for recurrent admissions for heart~     failure.~   "
106096|NCT01668446|"~     The target of this study was an estimate the result of sildenafil on ultrasonographic~     endometrial thickness, endometrial pattern investigation estrogen level on the day of~     progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo~     transfer cycles .~   "
105524|NCT01675934|"~     Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in~     the proximal colon compared to the distal colon. Possible reasons for this include bowel~     preparation often being worse in the proximal colon as well as flat depressed lesions being~     more common in the proximal colon.~      Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in~     the proximal colon is not currently routinely performed due to concerns of perforation and~     possibly because of the increased time required.~      Proximal colon retroflexion has been shown to be safe and effective without any~     complications, but data regarding ability to retroflex with certain types of colonoscopes is~     limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric~     colonoscopes. Studies have not been performed to comparatively evaluate the success rates of~     standard adult and pediatric colonoscopes and whether either type of instrument confers a~     greater polyp detection rate.~   "
105525|NCT01675921|"~     The investigators hypothesize that at the end of the 12-month trial, teenagers regularly~     self-monitoring their asthma control with ACT administered through Facebook will have~     improved ACT scores as compared with teenagers receiving usual care.~   "
105526|NCT01675908|"~     Compare the performance of full covered metal stents and plastic stents for preoperative~     biliary decompression~   "
105527|NCT01675895|"~     The main objective was to test the hypothesis that adding lidocaine to hyperbaric~     levobupivacaine could change the duration of levobupivacaine spinal block.~   "
105528|NCT01675882|"~     The objectives of this dose-finding study for the treatment of peanut allergy are:~        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg~          peanut protein per patch) to significantly desensitize peanut-allergic subjects to~          peanut after 12 months of treatment.~        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.~   "
105529|NCT01675869|"~     The purpose of this study is to see if an intervention training executive functions like~     attention, working memory, and self-regulation for preschoolers at risk for~     Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves~     attention, behavior, and functioning.~   "
105530|NCT01675856|"~     Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies.~     The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a~     crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of~     patients at their presentation, there remains a subgroup of patients who continue to bleed~     or develop recurrent bleeding. In these patients, the mortality increases manifolds. If~     these high-risk patients can be identified, early interventions may improve their outcomes.~      Several prognostic indices are in use for the purpose of patient stratification. They~     include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a~     composite score which incorporates clinical parameters as well as findings during endoscopy~     which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for~     the prediction for the need of further intervention loosely defined as the need for~     transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk~     patients for early discharge.~   "
105531|NCT01675843|"~     The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy~     rates in women with polycystic ovary syndrome. Infertile women with pcos will receive~     gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse~     (TI)~   "
105532|NCT01675830|"~     This is a phase I descriptive pilot study to determine the feasibility of using the Heat~     Retention Head Wrap on infants during the re-warming period following cardio-pulmonary~     bypass.~   "
105533|NCT01675817|"~     Recent work has shown that heparin rebound is common after cardiac surgery.~      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.~     Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also~     unknown if precise titration of protamine perioperatively in cardiac surgery can influence~     transfusion requirements after cardiac surgery.~   "
105534|NCT01675804|"~     Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation~     (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of~     children with attention deficit/hyperactivity disorder (ADHD).~   "
105535|NCT01675791|"~     The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree~     AIT administered once daily in order to define a dose-range that would be suitable for~     at-home administration.~   "
105536|NCT01675778|"~     Pain is the most common complaint for patients presenting to the emergency department (ED).~     Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and~     responses to intravenous opioids vary widely and are influenced by multiple factors. The~     objective of the current study is to examine the association between total body weight, BMI~     (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.~   "
105537|NCT01675765|"~     This clinical trial will evaluate the safety and immune response of the sequential~     administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by~     standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated)~     form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to~     cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207~     has been engineered to elicit an immune response against the tumor-associated antigen~     mesothelin, which has been shown to be present at higher levels on certain tumor cells (such~     as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard~     chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate~     whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune~     responses and/or objective tumor response.~   "
105598|NCT01674972|"~     The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1~     receptor agonists are used for the treatment of T2DM. Insulin resistance is a~     pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect~     in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1~     secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared~     to healthy controls. The results of this study will expand the knowledge of the~     pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.~   "
106106|NCT01668316|"~     The purpose of this study is to determine the effectiveness of a worksite diet and exercise~     program on weight loss in postpartum women.~   "
105538|NCT01675752|"~     1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol~     Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and~     adenomatous <10 mm polyps with that of histology in an European multi-center study. To~     assess variability among endoscopists in NBI accuracy. We also aim to assess whether this~     technology impacts the appropriateness of surveillance intervals.~      Design: 1) Before starting the patient enrollment, the participating endoscopists will~     attend an internet-based training program on the in vivo differentiation between~     hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be~     required for each endoscopist to be included.~      2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for~     inclusion. Patients with at least one histologically verified <10 mm polyp will be included.~     In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in~     order to rank between a high- and a low- level of diagnostic confidence, and thereafter will~     be sent for histological assessment. NBI- and histological accuracy in differentiating~     between hyperplastic and adenomatous lesions will be analyzed and compared, in order to~     assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI~     feasibility and accuracy in the study population, and to assess the variability among the~     endoscopists. Secondary outcome measures will be a cost analysis on how much savings would~     be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical~     inference on how many patients would be scheduled for an inappropriate post-polypectomy~     follow up, when follow up schedule is based on NBI classification. Clinical results will be~     analyzed using various statistical measures of significance.~      Clinical Site Locations: 10 European centres with NBI-technology~      1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site~     Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.~   "
105539|NCT01675739|"~     The purpose of this study is to evaluate the effectiveness of SMS (short message service of~     mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.~   "
105540|NCT01675726|"~     AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born~     very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the~     QoL reported by a French general population of reference. 3) to determine whether~     socio-demographic factors, neonatal features and neurocognitive status were impacting their~     QoL.~      METHODS:~        -  Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier,~          Nantes, Nîmes, Nice and Rouen).~        -  Inclusion criteria: all infants born before 28 weeks of gestation between January 2005~          and December 2007, from 7 to 9 years old of age at the time of evaluation.~        -  Written agreement to participate: collected from parents.~        -  Data collection: reports of children's QoL by children and their parents (using~          standardized validated questionnaires); clinical information about the children,~          obtained through a medical examination; children neurocognitive profile.~        -  Duration of inclusion: over 24 months.~        -  Population: of the six structures, approximately 300 children will be evaluated~          consistent with the active files of the participating centres and an attrition rate of~          30%.~      PERSPECTIVES This is one of the first studies to collect self-reported data on quality of~     life of school-age children (7-9 years) born before 28 weeks of gestation. A better~     understanding of demographic and clinical determinants of QOL of school-age very preterm~     children may help clinicians involved in the care of these children in their ethical and~     medical considerations.~   "
105541|NCT01675713|"~     The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1~     year) term effects on body composition and psychological health after a 10 to 14-weeks~     comprehensive lifestyle modification program for the treatment of severe obesity.~      The aims of the PhD project are to investigate whether an intensive lifestyle intervention~     leads to acute and short term (< 1 year) changes in:~        1. The BMI/Weight~        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass~          and visceral fat area)~        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and~          health-related quality of life~   "
105542|NCT01675700|"~     The purpose of this study is to determine whether a topical nitroglycerine patch applied~     daily over a trapezius trigger point can improve patients' symptoms.~      If there is improvement, this open label study will help determine the degree of improvement~     and contribute to the design of a larger double blind placebo controlled trial.~      We would consider moving forward to a large randomized trial if:~        -  The intervention is acceptable to patients (>= 70%) and~        -  Compliance is satisfactory (>=80%) and~        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the~          VAS.~   "
105543|NCT01675687|"~     This study is designed to verify that web based follow up intervention after a classic~     multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise~     self-efficacy, improve drop out rate and advance sustainability after weight loss of obese~     women.~      Research Questions and Hypotheses~        -  How does a web based follow up intervention change self-efficacy of women participating~          in an obesity intervention?~        -  How does a web based follow up intervention affect the drop out rate of women~          participating in an obesity intervention?~        -  How does a web based follow up intervention influence sustainability of women~          participating in an obesity intervention?~   "
105544|NCT01675674|"~     This study is being done to learn how many children and young adults who come to pediatric~     rheumatology clinics may have mucopolysaccharidosis (MPS). The study tests for 4 of the~     types of MPS: I, II, IVA, and VI. This can help researchers decide whether to create a~     screening program for MPS at pediatric rheumatology clinics. This study is being done in~     rheumatology clinics because the first symptoms of MPS are often joint problems such as~     stiff joints, and rheumatologists may be the first doctors that a patient with MPS visits.~     The study will also evaluate the utility of dried blood spot testing for MPS.~   "
105545|NCT01675661|"~     The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200~     mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on~     cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).~   "
105546|NCT01675648|"~     In Singapore, opiate substitution medication e.g. methadone is only licensed for use with~     specific population. The standard treatment is one week of detoxification assisted with~     diazepam and symptomatic treatment followed by one week of rehabilitation. However, diazepam~     is highly addictive and widely abused among heroin users and pharmacologically, does not~     reduce the physical and psychological craving for opioids which can trigger relapse. Many~     opiate patients undergoing inpatient detoxification leave prematurely (i.e. PID: patient~     initiated discharge) because of the severity of unpleasant withdrawal symptoms. The purpose~     of the study is to establish an alternative medication to reduce opiate withdrawal symptoms~     for use in Singapore by evaluating the clinical efficacy of Lofexidine versus Diazepam in~     the management of the opiate withdrawal syndrome during inpatient detoxification.~   "
105547|NCT01675635|"~     The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized~     patients with moderate to severe pain following surgery.~   "
105555|NCT01675531|"~     A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin~     (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy)~     who need opioid combination treatment with existing pregabalin of last dose prior to study~     enrollment without changing.~      The investigators will assess study objectives as below.~      Primary objective~        -  To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)~      Secondary objectives~        -  To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology~          Group-Neurotoxicity (FACIT-GOG/NTX)~        -  To assess physician's overall satisfaction~        -  To assess subject's overall satisfaction~        -  To assess safety~      The investigators have a hypothesis that Targin will show favorable efficacy & safety~     profile for CIPN patients.~   "
105556|NCT01675518|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is~     administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991~     in fasted and fed conditions are compared.~   "
105557|NCT01675505|"~     The purpose of the study is to investigate whether there are prognostic factors regarding~     the mental and functional adjustment of colon cancer patients following curative surgery.~     Patients will be selected using specific inclusion criteria. Prognostic factors investigated~     include personality characteristics, initial distress, medical, social and economic factors.~     The utmost purpose of the study is to assist clinicians with the timely identification of~     vulnerable patients in order to ensure their proper management and their optimal adjustment.~      Moreover this is the first study using the Distress Thermometer in Greek patients with~     cancer.~   "
105558|NCT01675492|"~     To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and~     effective in the treatment of mixed astigmatism.~   "
105559|NCT01675479|"~     Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe~     and effective for the treatment of Hyperopia.~   "
105560|NCT01675466|"~     Patients with acute abdominal pain comprise a significant proportion of attendances at~     emergency departments. These patients account for about a third of general surgical~     admissions in a typical day. In some cases, the diagnosis is clear from baseline~     investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains~     unclear but there are signs that necessitate urgent surgery (for example in cases of~     appendicitis). A final group exists where no clear explanation for the pain is found and~     where there are insufficient clinical signs to warrant surgery. These patients are said to~     have non specific abdominal pain (NSAP) and present a management dilemma.~      Traditionally such patients are managed with a strategy of active observation. Patients are~     examined at regular intervals and may undergo imaging. In some cases, symptoms and signs~     progress and surgery is needed while in other cases resolution may occur or a diagnosis may~     be reached non-operatively allowing focused medical treatment. Recently, two alternative~     strategies have emerged. Early cross-sectional imaging using CT scanning may identify~     conditions whilst being non-invasive. This would allow diagnosis and treatment would follow.~     The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of~     concomitant therapy, but is invasive.~      The study hypothesis is that in patients with acute non-specific abdominal pain active~     management with laparoscopy on admission will reduce hospital stay and costs when compared~     to traditional active observation, without increasing complications.~   "
105561|NCT01675453|"~     The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac~     surgery patients. Systemic inflammatory response initiated by CPB through releasing of~     several mediators lead to altered endothelial integrity and in consequence the leakage of~     proteins and fluids from the intravascular to the interstitial compartment is occurred.~     Increased capillary permeability and decreased colloid osmotic pressure were shown to play a~     key role for fluid shift and increasing of extravascular water. Further tissue edema can~     result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to~     adverse outcomes.~      Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a~     fluid shift from the intracellular and the interstitial spaces of tissue into the~     intravascular compartment.~      The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6%~     hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass~     grafting with cardiopulmonary bypass.~   "
105562|NCT01675440|"~     To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of~     symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the~     risk of surgical aortic valve replacement has a predicted operative mortality or serious,~     irreversible morbidity risk of ≥50% at 30 days.~   "
105563|NCT01675427|"~     This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes~     with disease characteristics and demographics in treatment-naïve and treatment-experienced~     chronic hepatitis C patients, including patients with HIV co-infection. There will be a~     single study visit for testing.~   "
105564|NCT01675414|"~     The purpose of this research study is to help us learn if children with Autism Spectrum~     Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than~     children without ASD do. The investigators hope to learn if children with ASD and~     gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and~     aggression, more than children with ASD but no GI disorders do. The investigators want to~     learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children~     with ASD also have gastrointestinal disorders.~      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are~     not identified by current diagnostic evaluation.~      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an~     elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing~     children. The investigators anticipate that the proposed study will raise the standard of~     medical care for children with ASD by improving current methods of identifying GI~     dysfunction and determining whether there is a significant relationship between GI~     dysfunction and PB in this population.~   "
105814|NCT01672138|"~     This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal~     atrial fibrillation patients using different ablation strategies such as 1) PVAI alone, 2)~     PVAI+ CFAE, 3) PVAI+ CFAE+ non-PV trigger ablation.~      [ PVAI: Pulmonary Vein Antrum Isolation CFAE: Complex Fractionated Atrial Electrograms~     Non-PV triggers: Triggers arising from sites other than pulmonary veins]~   "
105565|NCT01675401|"~     An increased body mass impairs vascular function (VF), an important characteristic of~     subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases.~     However, a wide variety of in vivo VF markers exists each measuring different aspects of VF.~     Each of these markers addresses a different aspect of the vasculature. Studies comparing~     under standardized conditions the differences and relationships of the many different VF~     measurements in lean and abdominally overweight / obese subjects are missing. Also, there is~     a great need to know which of these markers are sensitive to dietary challenges.~      Therefore, it is imperative to conduct an extensive study on dietary effects and~     interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and~     overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for~     cardiovascular disease. The investigators propose to examine, in a two-way~     parallel-randomized human intervention study, the effects of weight-loss in abdominally~     overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation~     and vascular activity during the fasting and both the postprandial and hyperinsulinemic~     state. Furthermore, differences - and relations between - VF measurements and plasma~     biomarkers will be compared cross-sectionally between lean and abdominally overweight /~     obese male subjects.~   "
105566|NCT01675388|"~     Newborn infants with severe respiratory failure are treated with extracorporeal membrane~     oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for~     brain injury as a result of hypoxia and blood flow changes in the brain prior to and during~     ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO)~     and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes,~     early diagnosis and intervention for brain injury, decreased cost and duration of clinical~     trials, decrease in the burden of chronic neurologic disease and disability in society, thus~     improving the health and quality of life of these infants as they progress through childhood~     into adulthood.~   "
105567|NCT01675375|"~     The purpose of this research is to determine if an investigational thin shield can~     effectively reduce discomfort following Laser Vision Correction.~   "
105568|NCT01675362|"~     This study will be conducted to evaluate the protective effects and mechanisms of~     antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and~     angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.~   "
105569|NCT01675349|"~     The objective of this study is to determine the biologic activity of a Chenopodium album~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
105570|NCT01675336|"~     A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in Chinese (Taiwan).~   "
105571|NCT01675323|"~     Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to~     address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss~     without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by~     overwhelming the normal inhibitory processes needed to decrease sensory and motor cortical~     activity for resting and sleep. Thus the hyperarousal produces both the RLS need to move~     when trying to rest and the inability to maintain sleep. The biological consequences of this~     hyperarousal process on sleep (increased wake time) and cortical excitability (as~     demonstrated by transcranial magnetic stimulation (TMS)) are postulated to reflect increased~     degree of excitatory glutamatergic activity, and therefore affected brain regions will show~     relatively increased glutamate (Glu) and glutamine (Gln) on MR spectroscopy (MRS). Changes~     in inhibitory activity and GABA may also occur, but less significantly than the increase in~     Glu/Gln. Our pilot MRS data discovered a new abnormality in RLS: increased Thalamic Glx (Glu~     + Gln) that correlated well with sleep measures of hyperarousal. Glx levels are not specific~     for the neurotransmitter role of Glu.~      In this project RLS and matching controls subjects will be studied using polysomnograms~     (PSG) and TMS and 7T MRI for MRS that provides accurate measurement of Gln levels, which~     reflect mostly neurotransmitter Glu activity. The first aim is to confirm that Gln is~     increased in the thalamus and to determine if this also occurs in the motor and sensory~     cortices. The relation between Glu, Gln and GABA will also be evaluated. Second, assessments~     will be made of the degree of relation between Gln increase and the hyperarousal effects on~     sleep and cortical excitability (TMS). This would demonstrate that abnormally increased Glu~     activity is primary to RLS hyperarousal and radically changes the emphasis in RLS to be less~     on dopamine and more on Glu-hyperarousal as a major feature of RLS.This is an entirely new~     direction for RLS research and treatment development. The new concept of hyperarousal adds a~     missing dimension to understanding RLS, namely the discovery of the Glu abnormality and its~     central relation to the other hyperarousal features.~   "
105572|NCT01675310|"~     Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that~     affect between 1 to 14% of population around the world.~      There is a few studies to prevent gestational diabetes mellitus in high risk women as~     Mexican population.~      Metformin has been used during pregnancy in women with gestational diabetes and women with~     polycystic ovary syndrome, with acceptable security for mother and fetus.~      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be~     decrease the risk of gestational diabetes mellitus in high risk women.~   "
105573|NCT01675297|"~     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,~     cholecalciferol combination tablet in patients with Osteoporosis.~   "
105574|NCT01675284|"~     The focus of this study is to evaluate the safety, reactogenicity and humoral immune~     responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30~     µg HA to human subjects.~   "
105575|NCT01675271|"~     The focus of this study is on individualized exercise prescription on primary prevention of~     cardiovascular diseases (CVD). Special attention is set on autonomic nervous system function~     and inflammation.~      This study will seek novel, cost-effective models of exercise prescription that will~     emphasize individuals own response on her health and which would be easily implemented to~     primary health care as primary prevention for CVD. According to power calculation,sixty~     women planning pregnancy with BMI equal or over 30 and/or history of GDM will be recruited~     and randomized to an individual exercise arm (n=20), a general exercise arm (n=20) and a~     control arm (n=20). General intervention group will receive general exercise and dietary~     counselling whereas a personal exercise and dietary programs will be planned for~     individualized exercise group. Those randomized to the control arm will receive no dietary~     and exercise information.~      Clinical exercise tests and autonomic nervous system tests will be performed in the~     beginning of the study and after 3 months intervention. Blood samples for markers of~     inflammation, glucose homeostasis and lipid status will be collected from prepregnancy~     period until 1 years after delivery.~   "
105829|NCT01671943|"~     The purpose of this study is to evaluate the clinical feasibility and safety of the~     ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.~   "
136708|NCT01265576|"~     The purpose of this study is to determine if VT-122 provides a clinical benefit when added~     to Sorafenib in patients with advanced hepatocellular carcinoma (HCC).~   "
105576|NCT01675258|"~     Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across~     the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers~     are mostly diagnosed only at later stages of the disease's course through histoimmune~     staining and molecular biology processes on the tissues biopsied from the gastrointestinal~     system under invasive diagnostic procedures of colonoscopy.~      Oral fluid presents a large protein complexity and has been recently used as a diagnostic~     biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the~     colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to~     bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal~     cancers. Proteomic technologies provide the tools needed to discover and identify~     disease-associated biomarkers.~      The aim of the present study is to identify salivary bio-markers in patients suffering from~     colorectal cancers.~   "
105577|NCT01675245|"~     The purpose of this study is to acquire information on the usage, effectiveness, safety, and~     levels of health care resource utilization associated with Velcade therapy in recurrent and~     refractory multiple myeloma patients who are initiating Velcade and various combination~     therapies within the approved indication in a naturalistic setting.~   "
105578|NCT01675232|"~     The purpose of this study is to investigate the efficacy of two different corticosteroid~     ointment application regimens for the treatment of eczema (atopic dermatitis).~   "
105579|NCT01675219|"~     Bladder cancer (BC), the second most common urological malignancy, is an important public~     health issue. One of the main challenges in the treatment of bladder cancer if the~     prevention of recurrences of non-invasive tumors, which is also associated with significant~     costs.~      The current study will investigate optimal treatment of patients with bladder cancer with~     high risk of tumor recurrence but low risk of progression. The main interest is comparison~     of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the~     efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant~     treatment.~   "
105580|NCT01675206|"~     This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis~     patients.~   "
105581|NCT01675193|"~     The purpose of this study is to determine the optimal screening intervals and~     cost-effectiveness of population-based vision screening in preverbal children in the~     Netherlands.~   "
105582|NCT01675180|"~     Purpose/Objective of the study:~      The main objective of the study is to investigate oral health awareness and attitudes~     towards oral health among Norwegian pregnant women and assess the impact of information~     about oral hygiene on the risk of dental caries during pregnancy.~      The hypothesis of the study are:~        1. The state of oral health during pregnancy depends on pregnant woman's preventive oral~          hygiene behaviour and practice.~        2. Pregnant women with high level of oral health awareness and positive attitude towards~          oral health are more likely to visit their dentists regularly and have better oral~          hygiene compared to those with less awareness.~        3. Proper information and guidance on oral hygiene care provided during pregnancy can help~          to improve oral bacteriological milieu and reduce the dental caries risk among pregnant~          women.~   "
105583|NCT01675167|"~     The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is~     effective in treating opioid-experienced subjects, with moderate to severe chronic low back~     pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended~     period of time.~   "
105584|NCT01675154|"~     Funding Source - FDA OOPD~      This study is being done to find out whether an investigational (not approved by FDA ) drug~     called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in~     combination can treat the high blood fat (elevated triglycerides)levels found in the~     condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,~     the current standard medical care.~      It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in~     lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The~     researchers are interested in learning whether any one of these drugs when given alone or in~     combination is more effective and safe in treating T1HLP.~   "
105585|NCT01675141|"~     Background:~        -  Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed~          at controlling symptoms and reducing the number of myeloma cells. It continues until~          the cancer stops responding to treatment. At that time, treatment may switch to~          maintenance therapy, which is given to try to extend the response of the first therapy~          for as long as possible. Research suggests that lenalidomide maintenance therapy may~          delay the time for myeloma cells to start to grow and possibly improve survival.~        -  Lenalidomide is a drug that may reduce or prevent the growth of cancer cells.~          Researchers want to look at the long-term effect of lenalidomide on immune cells. It~          will also look at the effects of extended treatment on the cancer and the immune~          system.~      Objectives:~      - To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          sample will be collected. A bone scan and bone marrow biopsy will also be performed.~        -  Participants will receive lenalidomide maintenance treatment. It will be given~          according to the standard of care for multiple myeloma. Participants will take~          lenalidomide every day for 21 days of repeated 28-day cycles.~        -  Treatment will be monitored with frequent blood tests. Blood tests will look at the~          effect of the treatment on the immune system.~        -  Treatment will continue as long as the cancer does not worsen and the side effects are~          not severe.~   "
105599|NCT01674959|"~     Radiation therapy plus concurrent chemotherapy has been demonstrated a significant~     improvement in overall and disease-free survival according to Intergroup Trial 0116 in~     patients with gastric cancer after surgical complete resection. Advantage of application of~     IMRT has been shown in planning comparison studies for postoperative gastric patients. So~     the investigators designed the trial to see safety and efficacy of postoperative concurrent~     chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.~   "
105600|NCT01674946|"~     The purpose of this study is do determine the functional significance of the G~     protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural~     bile acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.~   "
105586|NCT01675128|"~     Background:~      - Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the~     deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other~     chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They~     want to see if the drugs are a safe and effective treatment for advanced solid tumors or~     colorectal cancer that has not responded to other treatments.~      Objectives:~      - To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid~     tumors or colorectal cancer.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or colorectal cancer that has~     not responded to other treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. Tumor tissue samples may be collected as well before~          and after treatment. Imaging studies will also be performed.~        -  Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the~          first cycle, they will also have ISIS 183750 on days 3 and 5.~        -  Participants will take irinotecan every second week, beginning on day 15 of the first~          cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer does not grow and the side effects are~          not severe.~   "
105587|NCT01675115|"~     The objective of this study is to investigate the efficacy and safety of BNG-1 in patients~     with ischemic stroke. The efficacy assessment will be based on the functional outcome while~     the safety will be reviewed by the adverse events and laboratory examinations.~   "
105588|NCT01675102|"~     17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for~     approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome~     after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective~     EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45%~     (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell~     transplantation for chronic lymphocytic leukemia with 17p deletion: a retrospective European~     Group for Blood and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100).~      Referring to these favorable results and small additional series, patients with 17p-CLL~     requiring therapy are considered to have an indication for allogeneic transplantation by~     many CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part~     of the first- or second line treatment.~      The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first~     or second remission by a non-interventional prospective study. Patients shall be registered~     prior to HCT at the Leiden Office in order to rule out a reporting bias after~     transplantation.~   "
105589|NCT01675089|"~     The purpose of this study is to determine whether zolendronic acid, a third generation~     bisphosphonate, is effective in preventing bone loss in the first year after kidney~     transplantation.~   "
105590|NCT01675076|"~     The purpose of this study is to determine the best strategy to manage novel oral~     anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators~     hypothesize that performing device surgery without interruption of the novel oral~     anti-coagulant will result in a reduced rate of clinically significant hematoma.~   "
105591|NCT01675063|"~     The overall goal of this collaborative study is to advance the novel pulse contour~     analysis to the point at which it can be incorporated into a real-time device. The specific~     objective is to establish an auto-calibration algorithm that conveniently yields cardiac~     output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for~     analysis and reference pulmonary artery catheter CO measurements will be recorded from~     critically ill patients and then analyzed off-line at Retia Medical. Successful completion~     of this study may ultimately help lead to improved outcomes of critically ill patients.~   "
105592|NCT01675050|"~     The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover~     trial would help relieve abdominal pain associated with FAP in children, achieving a greater~     response than that observed with placebo. In addition to assessing self-report of pain and~     other symptoms, the investigators also propose to perform experimental somatic pain testing~     to determine if there is evidence of peripherally-maintained central sensitization in~     children with FAP. The investigators also hypothesize that there will be an increase in~     somatic pain threshold after completion of a Cyproheptadine course compared to baseline~     testing prior to treatment, and compared to placebo. This would allow children with FAP to~     return to normal function, improve symptoms and overall general well-being~   "
105593|NCT01675037|"~     Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment~     of obstructive hydrocephalus in children and adults. Perforation of the third ventricle~     floor which is part of the hypothalamic-pituitary neuronal network is the key of this~     surgical procedure.~      Purpose: There are no prospective data available about the endocrine effects after ETV in~     children and adults. The principal aim of this prospective study is to evaluate the~     variability of hypothalamic-pituitary hormones and clinical effects in children and adults~     after ETV in order to plan a multicentric study.~   "
105594|NCT01675024|"~     This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine~     after single and multiple doses of Rotigotine transdermal patch, and also to investigate the~     safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.~   "
105595|NCT01675011|"~     This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years~     with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six~     (36) months following uterine fibroid embolization.~   "
105596|NCT01674998|"~     The purpose of this research study is to determine if safe, simple and non-invasive tests~     such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify~     neurological disorders before typical symptoms occur. Researchers believe that early~     identification of these disorders could lead to treatments to prevent, delay, or slow the~     development of one of more of these diseases. Some people with REM sleep behavior disorder~     (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but~     many do not.~   "
105597|NCT01674985|"~     The purpose of this study is to investigate whether infusion of G-CSF mobilized~     HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine~     chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.~   "
136766|NCT01264822|"~     To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori~   "
105601|NCT01674933|"~     The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any~     further dental decay among 3-4 year old children in nursery schools.~      It is important to ascertain the additional preventive value that fluoride varnish may~     provide when applied in conjunction with other preventive measures which form part of a~     national dental health improvement programme targeting children at risk from dental decay.~     1600 children will be recruited into the study for 2 years.~   "
105602|NCT01674920|"~     CHOICES is a program to provide children and families with lifetime tools and lifestyle~     strategies to achieve and maintain a healthy body size. Both parents and children get~     active, learn about the food choices they can make, and about the roles of TV in their~     lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on~     experiences that connect into the participants' daily lives. In the study, the families were~     divided into two groups, beginning their classes 6 months apart. Body measurements were~     taken at baseline and every 4 months to 16 months.~   "
105603|NCT01674907|"~     This observational study will evaluate the use in clinical practice and the efficacy of~     Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received~     prior chemotherapy treatment in the metastatic setting. Patients for whom the treating~     physician has decided to initiate therapy with Avastin will be followed for 10 months.~   "
105604|NCT01674894|"~     This post-marketing, single-center prospective study will be conducted in an open-label,~     non-interventional setting, for women seeking fertility treatment and will describe cleavage~     dynamics in relation to the age of the oocyte and gonadotrophin treatment.~   "
105605|NCT01674881|"~     A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for~     breast cancer experience negative sequelae in the form of pain following treatment. Chronic~     pain is known to be associated with impaired social and emotional functioning, and thus~     presents a particular concern.~      Mindfulness-based intervention is among the complementary, psychological treatments, which~     cancer patients commonly seek out in relation to the course of their illness. Despite the~     popularity of mindfulness-based intervention among cancer patients, no studies have so far~     investigated the effect of mindfulness-based intervention on chronic pain in breast cancer~     patients. While no studies so far have focused on pain, there is evidence to suggest that~     mindfulness-based intervention is associated with improved psychosocial adaption to cancer.~     Furthermore, non-cancer research suggests that mindfulness-based intervention is associated~     with reduced pain experiences.~      The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy~     (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment~     for breast cancer and who experience chronic pain, will be randomized to an intervention~     group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the~     same time points, i.e. before the intervention (baseline), and three times after the~     intervention/control condition, with the last follow-up 6 months after the intervention. In~     addition, a number of potential moderators and mediators of the outcome will be explored.~     For example, recent studies indicate that adult attachment style may constitute an important~     moderator and/or mediator in the development of pain, and preliminary research has suggested~     that attachment style may moderate the effect of mindfulness-based intervention.~      The results will provide valuable new knowledge about the potential of MBCT as a treatment~     strategy for chronic pain in breast cancer patients, will contribute to the clarification of~     underlying mechanisms in the experience of and coping with pain, which could help the~     development of more effective, individualized interventions.~   "
105606|NCT01674868|"~     This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME~     study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the~     effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American~     sample of post-acute stroke patients. This trial will in addition examine the effect of~     treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial~     attention, as well as post-stroke fatigue and will evaluate the durability of observed~     effects. The results of this pilot trial will be used to develop power estimates for a~     larger trial and to evaluate recruitment and intervention completion rates for subjects in~     an American post-acute environment. There are two additional substudies: the first will use~     MRI to assess structural changes at the beginning and end of the intervention; the second~     will examine the relationship of serum biomarkers of inflammation to the intervention.~   "
105607|NCT01674855|"~     This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to~     daily G-CSF in chemotherapy-induced neutropenia.~   "
105608|NCT01674842|"~     This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients~     with ER negative, PR negative and HER2 negative breast cancer who have undergone~     breast-conserving surgery or mastectomy.~      Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of~     cisplatin when given concurrently with radiation therapy for participants with Stage II or~     III breast cancer who have undergone breast conserving surgery or mastectomy~   "
105609|NCT01674829|"~     To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with~     advanced dry AMD To evaluate the safety of the surgical procedures when used to implant~     MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To~     evaluate on an exploratory basis potential efficacy endpoints to be used in future studies~     of MA09-hRPE cellular therapy.~   "
105610|NCT01674816|"~     Problem:~      Currently, no system allows precise kinematic assessment of the knee and accurate guiding of~     orthopedic surgical actions in a minimally invasive fashion. However, such a system would~     prove useful in the clinical setting to improve the quality of surgical interventions at the~     knee.~      Hypothesis:~      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging~     and minimally invasive bony fixation allows precise kinematic assessment and surgical~     guidance in the routine clinical setting.~      Objectives :~        -  Demonstrating the capacity of the system to precisely measure 3D knee kinematics~        -  Quantifying the reproducibility of the kinematic measurements~        -  Measuring the impact of knee surgical procedures on knee kinematics~        -  Assessing the correlations between measured articular kinematics and clinical results~          after knee surgery~        -  Integrating the novel measuring system to the surgical flow of three knee surgical~          procedures~        -  Quantifying the precision and reproducibility of the surgical actions guided by the~          system~        -  Comparing the clinical results of surgeries guided by the system to those performed~          with the traditional technique~   "
105642|NCT01674387|"~     Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy~     on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical~     basis for the chronic neck pain treatment and evaluation of efficacy.~   "
105643|NCT01674374|"~     The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium~     myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on~     the management of mucositis (inflammation and ulceration that occurs in the mouth) brought~     on by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck~   "
105611|NCT01674803|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease~     has led to a significant reduction in morbidity. However, the first generation of these~     devices had no positive impact on the mortality after PCI (compared to bare metal stents),~     which was greatly attributed to a somewhat increased incidence of late and very late stent~     thrombosis. Concerns about the role of durable polymers as a potential trigger of~     inflammation and finally adverse events also led to the development of DES with~     biodegradable coatings, which leave after degradation of the coating only a bare metal stent~     in the vessel wall that does not induce an inflammatory response. While such biodegradable~     polymer DES are increasingly used in clinical practice, there is no data available from~     head-to-head comparisons between biodegradable and contemporary third generation durable~     polymer DES.~   "
105612|NCT01674790|"~     The objective of the 'Exploring potential synergistic effects of aerobic exercise and~     cognitive training on cognition after stroke' pilot trial is to investigate the combined~     effects of aerobic and cognitive training on cognition after stroke. This is to lay the~     groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months~     post-stroke will be randomly assigned into one of four following treatment groups: (i)~     aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic~     exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of~     motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions,~     please see detailed description below). We hypothesize that the combination of aerobic~     exercise and cognitive training will be more effective in improving cognition after stroke~     than either treatment on its own.~   "
105613|NCT01674777|"~     This study is to investigate the effect of food on the pharmacokinetics, the~     pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy~     non-elderly adult male subjects.~   "
105614|NCT01674764|"~     Despite many years of research, an incomprehensible amount of scientific efforts worldwide~     and billions of dollars invested, no effective therapy resulting in major neurological or~     functional recovery is available to date for traumatic spinal cord injury (tSCI). Although~     there is increasing experimental evidence from animal models that surgical decompression of~     the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive~     data yet. The main explanations for this lack of convincing evidence are relatively small~     sample sizes in previous studies, their predominantly retrospective nature, suboptimal~     measurement methods for the assessment of neurological deficits, and inappropriate recording~     and documentation of potential confounding factors.~   "
105615|NCT01674751|"~     This pilot study will test the feasibility and potential effectiveness of a novel approach~     to improve food choices by employees about what to eat for lunch. The intervention involves~     the testing of an on-line pre-ordering food program with nutritional information linked to a~     hospital cafeteria. In this study, the investigators use positive reinforcement of feedback~     and price discounts during the intervention phase, and then withdraw those components in~     order to assess the potential for changes to be retained after the study is over.~      The study draws on principles from the field of behavioral economics and behavioral change.~     The investigators test the effectiveness of the intervention with 30 employees (study~     participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein~     employees, 66% of those screened were identified as either overweight or obese. There are 3~     phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention~     without reinforcement) (P3). Participants are randomized to one of two groups (intervention~     and wait-listed controls).~      Our primary hypotheses are that:~        1. Participants will purchase lunches with fewer calories during the intervention compared~          to baseline.~        2. Participants will purchases lunches with fewer calories in the tapering phase compared~          to baseline.~      Secondary hypotheses include that, compared with baseline, participants will order lunches~     with less fat. Changes in participant weight based on self selected goals, and in a measure~     of mindful eating will also be investigated. The investigators expect that participant~     adherence will be associated with improved outcomes compared to those who are less adherent.~   "
105616|NCT01674738|"~     This study wants to determine the activity of a first-line treatment related to Thymidylate~     Synthetase (TS) Expression. Patients with the diagnosis of non-squamous advanced~     Non-Small-Cell Lung-Cancer (Stage IV) and without evidence of EGFR mutation may be enclosed~     in this clinical trial.~   "
105617|NCT01674725|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without~     cirrhosis.~   "
105618|NCT01674712|"~     This is a double-blind, randomized study designed to compare the efficacy and safety of two~     fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin~     145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the~     blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat~     in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has~     been marketed in more than 80 countries since 1975. Simvastatin is also used for the~     treatment of patients with a high level of cholesterol. These have also been marketed~     worldwide for more than 20 years. It is important to treat high levels of fats in the blood~     because it has been shown that even mildly elevated level of lipids in the blood can lead to~     diseases of the blood vessels. It has been shown in several studies and in clinical practice~     that the combination of fenofibrate plus simvastatin can lead to improved effects on blood~     fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the~     study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin~     145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing~     high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in~     reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.~   "
105619|NCT01674699|"~     The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether~     safety and outcomes of the device use in the commercial setting are comparable to the safety~     and outcomes of the device use in the IDE study.~   "
105620|NCT01674686|"~     The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin~     receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients~     with variant angina.~   "
105621|NCT01674673|"~     It is known that the treatment of panic disorder with medication and psychotherapy are both~     effective. Representative as a treatment for panic disorder, Selective serotonin reuptake~     inhibitors (SSRIs) are recommended as first-line treatment of panic disorder. In general,~     the initial reaction rate of panic disorder medication known to be frequently stopped early~     recurrence 70-80% It's too early, it is recommended that the duration of drug treatment for~     at least one year to be long-lasting. But whether it is appropriate for the duration of drug~     treatment to maintain a certain extent remains controversial, and maintain the medication~     for more than one year, even if the long-term effects known to be approximately 50% less~     than beyond being negative when remission based. Meanwhile, the typical method for the~     treatment of panic disorder psychology, cognitive behavioral therapy (Cognitive behavioral~     therapy) and looked comparable to the effect of the drug in the treatment of the known,~     especially in recent years when the combined treatment with medication can increase the~     long-term treatment of sexual reported that there's has been the subject of attention.~      But prospectively compare the long-term effects of these two treatments, research,~     especially the research about the long-term effects of the combined treatment with the drug~     treatment of panic disorder is very low, and almost nil is Researchers, drug treatment and~     the effect of the combined treatment in patients with panic disorder over two years~     prospective study to compare the plans were. And verification, the researchers performed~     only through this study by comparing the long-term effects of the combined treatment with~     medication combined treatment of medication to be more effective than if the reaction to the~     long-term treatment of panic disorder that can affect the clinical and biological factors~     navigate to evaluate them. In addition, long-term observational study, panic disorder~     patients' subjective quality of life actually improved to some extent on the map together~     proven to.~   "
105622|NCT01674660|"~     The purpose of this study is to explore the factors associated with interdialytic blood~     pressure variability in maintenance hemodialysis patients, especially the association~     between volume status and blood pressure variability.~   "
105623|NCT01674647|"~     A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo~     cardioversion (procedure to restore normal heart rhythm). The study will compare patients~     assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist~     (VKA). The study will measure common medical outcomes for this type of patient such as~     bleeding and stroke.~   "
105624|NCT01674634|"~     The primary objective of this study is to assess the safety of two concurrent injections of~     AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable~     cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of~     occurrence of targeted serious adverse events (tendon rupture/ligament injury and~     anaphylaxis) to historical rates of the same in clinical studies and post-marketing~     commercial use.~      The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.~   "
105625|NCT01674621|"~     To determine the clinical safety and efficacy of BA058 Transdermal in otherwise healthy~     postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD)~     and serum markers of bone metabolism when compared to Transdermal Placebo and BA058~     Injection for 6 months of treatment.~   "
105626|NCT01674608|"~     Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their~     care. They develop muscle weakness even after only a few days of mechanical ventilation that~     may prolong their time in ICU and in hospital, but the nature of such weakness is poorly~     understood.~      The weakness that develops in ICU is more substantial than that which would result from bed~     rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due~     to the combination of inflammation and immobility. The exact mechanisms leading to the nerve~     and muscle damage which occurs in critical illness are not yet fully understood and require~     further investigation. However, it is known that ICUAW has an effect on a patient's ability~     to breathe without a ventilator, walk and perform simple activities (like washing and~     toileting) and often results in longer mechanical ventilation time and hence, longer~     hospital stays than might otherwise be expected. It may also affect a patient's ability to~     return home after their hospital stay. The recovery period in Australian and New Zealand ICU~     patients is unknown but a trial from Canada has reported ongoing weakness five years after~     leaving ICU. Weakness in survivors of intensive care is known to be a substantial problem.~     It is currently not known whether ICUAW may be avoided or its severity reduced with simple~     strategies of early exercise in ICU.~      There are no data about the level of activity and mobility in critically ill patients in~     Australian and New Zealand ICUs. These data are urgently required to plan a program of~     research to test whether increasing the level of mobility and activity in our critically ill~     patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and~     improving patient-centred outcomes. The program of research will first include a study to~     observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety,~     barriers to mobility and what type of activities are undertaken by our patients.~      From the observational data we plan to develop a pilot randomised controlled trial of early~     mobility and activity in intensive care units across Australia and New Zealand. This simple,~     cost-effective strategy may improve functional ability, decrease time on mechanical~     ventilation and improve long term outcomes in this patient group. By initiating such a~     program, ANZ investigators might be able to change future patient outcomes worldwide.~   "
105627|NCT01674595|"~     This trial is an open, national, multi-centre trial. The trial will be initiated after olive~     pollen season 2012 and subjects will receive treatment for 6 weeks.~      The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The~     frequency of patients with adverse reactions will be the primary endpoint.~      Frequency of patients with systemic reactions according to EAACI classification, increase in~     IgG4 and in IgE and reduction in immediate skin reactivity.~   "
105628|NCT01674582|"~     The main purposes with this trial is to investigate the potential of MRI with diffusion and~     blood volume, flow in brain to diagnose and to measure treatment effects in patients with~     intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate~     the possibilities to individually adjusted treatment in this category of patients depending~     on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI~     to evaluate a correlation and to perform testing of cognitive ability before, during, and~     after treatment and to investigate if given treatment causes any decrease in the patients~     habitual state.~   "
105629|NCT01674569|"~     The objective of this study is to evaluate the safety and preliminary biologic~     activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD).~     Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein~     leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus~     photography, fluorescein angiography and optical coherence tomography (OCT).~   "
105630|NCT01674556|"~     The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable~     tumours~      The specific sub-objectives of the studies are:~        -  To quantify tumour sizes and relate it to the patient survival over time, dependent of~          treatment method.~        -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with~          US contrast agent under sonication with gemcitabine alone.~        -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment~          for diagnosis and monitoring of therapy.~        -  To quantify gemcitabine and its main metabolites in plasma and in circulating~          mononuclear cells before, during and after pancreatic sonication, and to quantify the~          concentration of intracellular endogenous nucleotides in circulating mononuclear cells~          at the same time points.~        -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and~          endogenous nucleotides in those patients where surgical resection can be performed on~          standard clinical indications.~   "
105663|NCT01674114|"~     The purpose of this study is to investigate whether a regional-block (TAP block) in~     Caesarean section will give a measurable benefit in form of reducing Morphine consumption as~     compared to local infiltration of the wound with local anesthetic.~   "
105631|NCT01674543|"~     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,~     affecting 1% of the population. The treatment of schizophrenia is basically done with~     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a~     form of treatment seems to be considered. Among the most recommended exercise for the~     general population, the investigators highlight the aerobic and resistance exercises.~     However, few studies have reported the positive effect of aerobic exercise in the~     pathogenesis of schizophrenia. In relation to resistance exercise and concurrent training,~     it is unknown if the effect in patients with the disease, especially when one considers the~     junction of the two types of exercises in the same training session (called concurrent~     training). However, it is known, through clinical studies and animal models, that exercise~     modifies the brain improves neuroplasticity, the mental condition of the individual frames~     and reverses neurodegeneration. Associated with improvement in schizophrenia, few clinical~     trials of aerobic exercise showed improvement in disease symptoms, reducing anxiety and~     depression, and clinical global improvement. The hypothesis is that the types of proposed~     training, resistance training and concurrent training can improve clinical symptoms of the~     disease, and improve the side effects caused by drugs. It is believed that the clinical~     changes are accompanied by increased serum IGF-1 by resistance training and aerobic training~     by BDNF.~   "
105632|NCT01674530|"~     The objective of this study is to evaluate the clinical equivalence and safety of the test~     formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd~     compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo~     Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation~   "
105633|NCT01674517|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
105634|NCT01674504|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
105635|NCT01674491|"~     Black soy peptides have been shown to possess properties that may decrease blood pressure.~     To examine the effects of black soy peptides supplementation on blood pressure and oxidative~     stress in subjects with pre-hypertension or stage I hypertension.~   "
105636|NCT01674478|"~     Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common~     devastating gastrointestinal diseases in premature infants. These infants often need~     surgical intervention to remove the dead bowel and create temporary enterostomies, resulting~     in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or~     dysfunction to digest and absorb nutrients adequately.~      These infants are often nourished primarily with parental nutrition (PN) which can lead to~     many complications including PN-associated liver disease. However, with enteral feeding, the~     remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral~     fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty~     acids (LCPUFA) being the most beneficial in promoting bowel adaptation.~      Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.~     Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and~     increase weight gain in some SBS infants. WThe investigators will soon have completed a~     randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled Early~     Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with~     Enterostomies. The preliminary data suggest that (a) by supplementing enteral ML/FO, we~     were able to decrease the use of IL; (b) premature infants in the treatment group who~     received ML/FO achieved higher enteral calorie (% of total calorie) intake before~     reanastomosis and better weight gain (g/day) after reanastomosis than those who received~     routine care in control group; and (c) the direct bilirubin level before reanastomosis~     tended to be lower in the treatment group than the control group although the difference was~     not statistically significant. Because the intervention consisted of both an increase in~     enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether~     improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or~     the increased fat intake. Therefore, the investigators have designed a next randomized~     clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML~     alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood~     levels of inflammation-related proteins and indicators of oxidative stress.~   "
105637|NCT01674465|"~     Calcineurin Inhibitors (CNI) are drugs used to suppress the immune system when a person has~     a solid organ transplant. Although these drugs keep the transplanted organ from being~     rejected they are toxic to kidneys, or nephrotoxic. CNIs cause damage, called fibrosis, to~     kidneys.~      Fibrosis is a type of scarring that occurs in kidney tissue. Fibrosis can eventually lead to~     kidney failure. One of the pathways that cause fibrosis is a chronic lack of oxygen to the~     kidney tissue called hypoxia. There is a protein called Nox2 that may be involved in how~     this hypoxia happens in the kidney. The Department of Medicine-Nephrology at the University~     of Wisconsin is conducting a research study to see how much of the Nox2 protein is present~     in kidneys that may have fibrosis caused by CNIs and whether a certain type of Magnetic~     Resonance Imaging (MRI) can be used to tell in advance if the disease caused by CNIs is~     getting worse. Study hypothesis: MRI, a non-invasive technique, can be used to determine~     whether CNI induced kidney disease is getting worse. Additionally, the study aims to~     determine the role of Nox2 in CNI nephrotoxicity.~   "
105638|NCT01674452|"~     The aim of this study is the development and the implementation of a new protocol about~     home-based exercises, supported by an illustrated manual, for the treatment of individuals~     with stroke.~      The hypothesis is that this group of patients who are going to carry out the training of~     this study protocol are going to show improvement in measured parameters (functionality and~     physical performance), which allows this protocol to be improved and published as a proposal~     of physiotherapeutic treatment.~   "
105639|NCT01674439|"~     Although first reports of the clinical use of adipose-derived regenerative cells (ADRC)~     suggest that this approach may be feasible and effective for soft tissue augmentation, there~     is a lack of randomized, controlled clinical trials in the literature. Hence, this study~     aimed to investigate whether a novel protocol for isolation of ADRC and their use in~     combination with fat tissue improve the long-term retention of the grafts in patients with~     craniofacial microsomia.~   "
105640|NCT01674426|"~     This is a randomized pilot study of the use of cognitive behavior therapy versus observation~     to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.~   "
105641|NCT01674413|"~     This is a study that invites adults with Crohn's disease and have been responding well to~     Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance~     medications in Crohn's disease, particularly when in remission. Patients want to know that~     they truly need to take a medication, yet they don't want to have flares. The purpose of~     this study is to see that if we monitor the patient, along with looking at changes in their~     stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks,~     or add as-needed dosing only, and keep them in remission.~   "
105644|NCT01674361|"~     This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of bitopertin (RO4917838) in combination with selective~     serotonin reuptake inhibitors (SSRI) in patients with obsessive-compulsive disorder.~     Patients will be randomized to receive either bitopertin 30 mg or bitopertin 10 mg or~     placebo orally daily in addition to their background therapy with an SSRI. Anticipated time~     on study treatment is 16 weeks.~   "
105645|NCT01674348|"~     It is a phase II, randomized, double-blind, placebo-controlled study of P2202 in patients of~     type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or~     sulfonylurea or both.~   "
105646|NCT01674335|"~     Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people~     with pain try to continue their daily activities at the same level as they were able to~     manage before they had pain. This way of coping causes increases in their pain; they become~     discouraged and give up on their activities. AP treatments involve helping them regulate~     their activity level so that they can achieve important life goals. Although AP is widely~     used, its effectiveness is still unproven. There are two key approaches: The operant~     learning (OL) approach uses quotas related to time or goals the person sets. The energy~     conservation (EC) approach focuses on balancing patient energy expenditure. Both of these~     treatments have often been used with people with Fibromyalgia Syndrome (FMS), a common pain~     condition. We will examine the effects of these treatments on pain, fatigue, quality of~     life, physical functioning and mental well-being. We will also investigate whether other~     factors influence treatment effectiveness (e.g., a person's readiness to change, pain~     intensity level). 120 FMS patients will be randomly assigned to receive OL, EC, Delayed-OL~     or Delayed-EC. Data will be collected at baseline, at the end of treatment and at 3, 6 and~     12 month follow-ups. FMS patients will be recruited consecutively from Rheumatologists at~     St. Joseph's Health Care London. OL and EC treatment manuals will be developed by experts in~     the field and both interventions will be given by two occupational therapists over a 3 month~     period as stand-alone interventions (10 sessions of 120 min). All sessions will be~     recorded in order to assess intervention fidelity. This study will be the first to base AP~     interventions on a clearly delineated theoretical framework. It will clarify whether AP~     strategies benefit individuals with FMS and whether either of these two approaches is more~     effective. Our results will help to direct clinical resources and funding toward the most~     beneficial interventions.~   "
105647|NCT01674322|"~     The purpose of this study is to investigate the absorption, the metabolic pathways and the~     excretion of ibrutinib in healthy male adult participants after administration of a single~     oral dose of 50 mg to 140 mg (5 mg/mL solution) of unlabeled ibrutinib admixed with 14C~     ibrutinib.~   "
105648|NCT01674309|"~     The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,~     with an objective response rate of about 70 %. This phase II is to investigate if this~     systematic attack chemotherapy could control at the same time the rectal tumor and the~     synchronous metastasis without compromising secondarily the tumor or the metastasis~     resection or a radiochemotherapy administration.~        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,~          according to the RECIST criteria (version 1.1).~        2. The secondary objectives are:~             -  safety of the treament,~             -  rate of local failure and local complication (occlusion, important bleedings,~               resistant pains with morphinic treatment, perforation),~             -  survival without local failure (radiological or clinical progression of the rectal~               cancer or local complication),~             -  rectal tumor response rate (CT scan, MRI and endocopy),~             -  metastasis response rate,~             -  disease free survival after complete resection (of primitive tumor and~               metastases),~             -  progression free survival (local or distal),~             -  overall survival, quality of life (QLQ-C30 + CR 29).~   "
105649|NCT01674296|"~     The purpose of this study is to develop a better understanding of factors affecting~     American's energy balance related behaviors - in this case, food intake and activity. In the~     present study we will describe the relative contributions of individual psychology and~     physiology (including metabolism, mood, and sleep habits) and external (season, stressors)~     contributions to changes in adiposity over a year in free-living individuals.~      This study will illuminate season's role in changes in energy balance related behaviors and~     body weight and composition. Ultimately, this information will be used to identify factors~     affecting food consumption and individual activity during seasonal periods to help to~     segment interventions for obesity prevention in mid-life women.~   "
105650|NCT01674283|"~     The success of in vitro fertilization is based mainly on uterine implantation embryo. An~     excessive uterine contractility may interfere with implantation by a movement of the embryo~     in the uterus. The inhibition of the uterine contractility may have a positive effect on~     success rate of in vitro fertilization. It is through parenteral injection of glucagon and~     its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the~     time of embryo transfer, the investigators intend to improve the pregnancy rates obtained~     after IVF.~   "
105651|NCT01674270|"~     To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on~     intratumoral levels of androgens.~   "
105652|NCT01674257|"~     Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks~     and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing~     atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with~     hardening of the neck arteries due to undergo surgery to remove the hardened areas. The~     investigators will then be able to compare the hot spots found on these scans with what the~     investigators can see in the removed specimens under the microscope in the laboratory. This~     will give investigators insight into the value of PET CT and MRI as tools for assessing~     atherosclerosis. It will also provide the investigators with new information relating to the~     underlying processes that give rise to atherosclerosis and will pave the way for the future~     development of new treatments.~   "
105664|NCT01674101|"~     This application proposes a prospective clinical trial to evaluate the impact of adding a~     focused physical therapy (PT) intervention to the preoperative regimen of individuals~     diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to~     determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week~     preoperative strengthening, stretching, and aerobic exercise regimen.~   "
105665|NCT01674088|"~     Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US~     population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of~     the disease still remains unclear. It has been hypothesized that patients with IBS have~     alterations in the intestinal lining leading to release of toxic substances into the blood,~     commonly referred to as leaky gut. Current methods used to study leaky gut are both~     expensive and invasive. The investigators will test a new breath test to measure leaky gut~     in both IBS patients and subjects without IBS symptoms.~   "
105653|NCT01674244|"~     Despite the considerable efforts of the DoD and VA to improve awareness of mental health~     problems and access to care, many returning veterans still report substantial barriers to~     seeking traditional mental health care. Research suggests that a significant barrier to~     pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of~     this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the~     utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise~     and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)~     symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.~     Specifically, this study will examine whether a 12-week course of Integrative Exercise~     therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD~     symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves~     other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological~     distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist~     condition) and 3) whether such treatment is feasible and acceptable.~      A secondary aim of this study is to evaluate possible mechanisms underlying these effects~     such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic~     capacity, and improved sleep.~   "
105654|NCT01674231|"~     The investigators hope to learn about the effects of whole grapes, in the form of~     freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is~     associated with protection against chronic diseases such as cardiovascular disease (CVD)~     demonstrating the ability to modify endothelial function and lipemia, but exact causal~     mechanisms are still not well understood. The investigators will examine metabolic and~     mechanistic effects of consumption of whole grape powder in chronic as well as acute~     settings in response to meal challenges by testing blood samples to determine if markers of~     health have improved.~      The central hypothesis of this project is that consumption of grapes in the form of a~     polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal~     induced oxidative stress and inflammatory responses in obese individuals.~   "
105655|NCT01674218|"~     This is a Phase I, single-center, double-blinded, randomized, placebo-controlled,~     five-period cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of~     PA-824 plus moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of~     75 healthy male and female participants, aged 18 to 45 years. Moxifloxacin will be used as~     an active control. Participants will be blinded to the treatments they will receive. The~     study consists of a screening period up to 26 days; enrollment, 1 day; five in-patient~     treatment periods consisting of an admission day (except in the first treatment period, when~     the pre-dose day is the baseline), dosing day and two post-dosing days; an out-patient~     period of at least three days and not more than 10 days between treatment periods; and a~     final visit 7 - 14 days after discharge from the last treatment period.~   "
105656|NCT01674205|"~     This study seeks to understand the host factors that affect the replication and immune~     response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in~     humans and to develop biomarkers that can predict the viral shedding and immune response to~     LAIVs.~   "
105657|NCT01674192|"~     The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of~     prucalopride in subjects with various degrees of renal impairment compared with normal renal~     function and to monitor the safety profile of prucalopride in subjects with renal~     impairment.~      Hypothesis:~      Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally~     impaired subjects compared with the normal population.~   "
105658|NCT01674179|"~     The purpose of this study is to retrospectively analyze Clinical and Nocturnal~     Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.~      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent~     awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during~     routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha~     intrusions may be an objective marker for Fibromyalgia and may correlate with current~     clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.~   "
105659|NCT01674166|"~     The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03~     mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal~     retention.~      Hypothesis:~      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the~     adult pharmacokinetic profile~   "
105660|NCT01674153|"~     Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims~     of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of~     dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and~     it is suggested that exercise increases the cardiac output, thus increases the blood flow to~     lower extremities. This leads to increased toxin removal from low blood flow regions. On the~     other hand, exercise can possibly dilate the vasculature and decrease the compartmental~     resistance. In this study, the investigators aim to investigate the exercise induced~     physiological changes which enhances the toxin removal. This information combined with~     patient specific mathematical models will encourage clinicians to opt for Optimal~     intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted~     renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin~     removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional~     hemodialysis.~   "
105661|NCT01674140|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or~     exemestane, may fight breast cancer by lowering the amount of estrogen the body makes.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. It is not yet know whether hormone therapy is more effective when given with or~     without everolimus in treating breast cancer.~      PURPOSE: This randomized phase III trial studies how well giving hormone therapy together~     with or without everolimus work in treating patients with breast cancer.~   "
105662|NCT01674127|"~     The present study examined the effects of Methyldopa on uterine artery diameter, uterine~     artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with~     Preeclampsia, using Doppler ultrasound.~   "
111125|NCT01601717|"~     The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment~     for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.~   "
105666|NCT01674075|"~     The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free~     anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid~     delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First~     introduced in 2001, it uses compressed carbon dioxide for drug delivery into the~     subcutaneous space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for~     both children and adults.~      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth~     et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no~     significant untoward effects, including in children as young as 3 years old (Zempsky et al,~     2008). However, two recent cases of toxic serum lidocaine levels in pediatric patients at~     Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.~     Both patients were administered local anesthetic using the J-Tip device prior to~     needle-stick and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).~      Currently, there is a limited amount of literature available on the safety profile of the~     J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following~     its use, likely on the assumption that systemic absorption from the small amount of~     lidocaine within the device should be negligible. The two pediatric cases highlighted above,~     seem to suggest otherwise. The purpose of this pilot study is to assess the safety of the~     J-Tip device on a small population of healthy adults and to determine if elevated lidocaine~     levels are present systemically or locally. The primary outcome will be lidocaine serum~     levels following the administration of the J-Tip device measured at the local site and two~     distal sites to establish lidocaine serum levels following J-Tip administration. We expect~     lidocaine levels to be undetectable.~   "
105667|NCT01674062|"~     This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with~     Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on~     trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the~     efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and~     clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840~     milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks.~     Trastuzumab will be administered at the same schedule the participant was following before~     entry into the study. An additional cohort of participants at certain centers will receive~     pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every~     3 weeks. These participants may have trastuzumab added to the regimen in the event of~     progression during single-agent pertuzumab treatment.~   "
105668|NCT01674049|"~     The purpose of the proposed study is to examine the timing of post-exercise feeding on 15~     hours post-exercise glycemic control and metabolic flexibility and in overweight and obese~     young men with a family history of type 2 diabetes.~      Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate~     post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin~     sensitivity, and metabolic flexibility (as evaluated by sleep RQ) in this same group of~     participants. We hypothesize that a 3 hour delay in nutrient ingestion will promote~     significantly greater improvements in glucose tolerance, metabolic flexibility, and~     peripheral insulin sensitivity both immediately and several hours post-ingestion.~   "
105669|NCT01674036|"~     The objectives of this study are to assess the tolerability, safety and pharmacokinetic~     parameters of Genz-682452 in healthy adult males, in two parts.~      Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential~     ascending single dose study;~      Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment~     crossover study with a minimum wash-out period; to obtain preliminary information on the~     pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and~     fasted conditions.~      Subjects are not allowed to participate in more than 1 part of the study.~   "
105670|NCT01674023|"~     MicroRNAs are important regulators of many cellular functions but their expression profile~     in human vitreous is still unclear. Aim of this study is to investigate microRNA expression~     profile by PCR in human vitreous of patients with various vitreoretinal disorders and~     compare with that of patients with macular holes which are suggested to be similar to that~     of healthy subjects.~   "
105671|NCT01674010|"~     The primary purpose of this study is to determine whether ELND005 is effective in the~     maintenance treatment of bipolar 1 disorder when added to other therapies.~   "
105672|NCT01673997|"~     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol~     Succinate Extended-Release Tablets 200 mg under fasting conditions~   "
105673|NCT01673984|"~     The purpose of this study is to demonstrate that treatment with a 6-monthly injection of~     hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy~     injections available for treating prostate cancer. The study will also aim to answer whether~     both doctors and patients would prefer treatment with a 6-monthly injection rather than~     injections every 3 months.~   "
105674|NCT01673971|"~     The investigators hypothesize that there are differences between infantile hemangiomas (IH)~     during the proliferating and involuting phases and in response to medical treatment that can~     be detected by optical tomography of these hemangiomas.~   "
105675|NCT01673958|"~     The aim of the present project is to compare the acute and chronic effect of stair~     descending versus stair ascending exercise on muscle damage and performance in elderly males~     with chronic heart failure.~   "
105676|NCT01673945|"~     The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in~     the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent~     organs, with the aim of establishing for which lesions and from which location the~     capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS~   "
105677|NCT01673932|"~     The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear~     cells (UCBMC) treatment of chronic ischemic stroke.~   "
105678|NCT01673919|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8~     mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.~   "
105712|NCT01673464|"~     The main purpose of this study is to prospectively examine changes in Brain Network~     Activation(BNA)following concussion in high school athletes. In addition, the study will~     examine the relationship between changes in BNA to symptoms, cognitive performance and~     vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high~     school athletes with concussion.~   "
105713|NCT01673451|"~     This is a single-center, randomized, double-blind, placebo-controlled, sequential,~     multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy~     adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening~     dosing).~   "
105679|NCT01673906|"~     The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has~     traditionally been a challenging issue. The last two decades have been marked by the~     application to use in the diagnosis of NETs of 3 newly available diagnostic techniques:~     endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron~     emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study~     conducted at a single referral centre that compared PET with conventional somatostatin~     receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by~     NET, PET detected more primary and secondary lesions than other methods. Recent studies~     investigated the clinical impact of PET in the management of patients affected by NET,~     previously studied by MDCT. The investigators recently reported the results of the~     investigation of 19 patients suspected of having primary pancreatic NET and studied by PET,~     MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more~     sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is~     probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET~     in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical~     impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these~     tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the~     diagnostic algorithm of patients suspected of having duodenal-pancreatic NET remains~     undefined.~      The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the~     diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The~     investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm~     (the dimension of the study sample is estimated in order to detect a 10% difference). The~     impact of PET on management plan of affected patients will also be evaluated. As a secondary~     endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of~     primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective,~     non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed~     order.~   "
105680|NCT01673893|"~     The purpose of this registry is to determine if delivery of weight adjusted, in a large dose~     with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for~     primary coronary intervention lowers readmission rate. This is done in comparison to the~     historical control of the Medicare/Medicaid readmission database. The registry will record~     the use of the product during the index procedure, and determine whether or not the patient~     was readmitted within 30 days, related to the index procedure.~   "
105681|NCT01673880|"~     This is a single-center, open-label, randomized crossover study being conducted in three~     cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of~     three cohorts (approximately 12 subjects per cohort) and they will receive both a single~     dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in~     random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.~   "
105682|NCT01673867|"~     The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as~     compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer~     (NSCLC) after failure of prior platinum-based chemotherapy~   "
105683|NCT01673854|"~     The purpose of this study is to assess the safety profile of vemurafenib, 960 mg,~     administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600~     mutated advanced/metastatic melanoma.~   "
105684|NCT01673841|"~     In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2)~     with relative and absolute cerebral oxygen saturation (rScO2) measurements. They~     hypothesized that previously reported contradictory results regarding the equivalence of~     SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.~      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were~     included. 4 disposable oxygenation sensors were applied bilaterally on the patient's~     forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were~     placed just above the eyebrows, and the sensors of the other monitor were placed just above~     the former sensors. The sensors placement was determined at random by a computerized~     randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All~     variables were recorded continuously. The study ended at the end of the operation.~   "
105685|NCT01673828|"~     This study will provide initial data on the safety and effectiveness of allopregnanolone in~     improving neurobehavioral outcome and reducing mortality in adults with moderate and severe~     traumatic brain injury.~   "
105686|NCT01673815|"~     Fundoscopy is an important aspect of the neurological examination, but can be challenging in~     uncooperative children. This study explored whether viewing a video (selected by patient or~     caregiver) during eye examination improves the success, duration and ease of pediatric~     fundoscopy.~      Hypothesis: Showing a short video clip during a fundoscopic exam will increase the~     probability of successfully visualizing the optic disk and reduce the amount of time needed~     to perform a fundoscopic exam in children between 1-8 years old.~   "
105687|NCT01673802|"~     The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced~     dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to~     address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher~     resolution delineation of these often infiltrative tumors on single-source, Dual-Energy~     Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable~     with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to~     aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the~     hilar variety.~   "
105688|NCT01673789|"~     Alopecia Areata (AA) is one of the most common T cell-mediated autoimmune diseases, leading~     to the chronic and relapsing hair loss. The prevalence of AA worldwide is 0.1 to 0.2%,~     affecting an estimated 5.3 million people in the United States. To date, the clinical~     therapies are limited and disappointed for the treatment of AA. Alternative approaches are~     needed. Increasing evidence demonstrates that stem cells possess the function of immune~     modulation. We established the Stem Cell Educator therapy by using cord blood-derived~     multipotent stem cells (CB-SCs)(Zhao Y, et al. BMC Medicine 2012). A closed-loop system that~     circulates a patient's blood through a blood cell separator, briefly co-cultures the~     patient's lymphocytes with adherent CB-SCs in vitro, and returns the educated lymphocytes~     (but not the CB-SCs) to the patient's circulation. Our clinical trial reveals that a single~     treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows~     regeneration of islet beta cells and improvement of metabolic control in subjects with~     long-standing type 1 diabetes (T1D), which is another most common T cell-mediated autoimmune~     disorder in the United States. Here, we develop and explore the therapeutic effectiveness of~     Stem Cell Educator therapy in AA patients.~   "
105689|NCT01673776|"~     This study is designed to compare the outcome of patients with proximal femoral fractures~     with different perioperative regimes: a group with a multimodal intervention and a control~     group.~   "
105690|NCT01673763|"~     The presented study is designed to analyze the efficacy of pancreatic stent insertion in~     patients undergoing ERCP with accidental cannulation of the pancreatic duct.~   "
131016|NCT01340534|"~     The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can~     reduce the incidence of surgical site infection after emergency cesarean section.~   "
105691|NCT01673750|"~     This is an observational study that seeks to gather information about perceptions of body~     image through the use of a one-time questionnaire completed by participants at the time of~     study enrollment.~      Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human~     Immunodeficiency Virus (HIV) has become possible through the use of Highly Active~     Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS~     has transitioned from a terminal illness to one which is treated as a chronic condition. One~     particular group that has been impacted tremendously by HIV in the United States is the~     adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers~     are beginning to examine ways in which the disease can affect one's physical health, mental~     health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has~     suggested that increased attention to and negative views of one's body image may be found at~     a higher rate in this group. To our knowledge, very few studies have examined this~     relationship in adolescents with HIV.~   "
105692|NCT01673737|"~     Primary Objective:~      Part A - Monotherapy:~      - To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and~     either on a once or twice daily schedule, to patients with advanced solid tumors or~     lymphomas.~      Part B - Combination:~      - To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination~     with the recommended standard dosage of vemurafenib to patients with unresectable /~     metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma.~      Secondary Objectives:~        -  To characterize the overall safety and tolerability profile of SAR260301 administered~          as monotherapy (Part A) and in combination with vemurafenib (Part B).~        -  To characterize the pharmacokinetic (PK) profile of SAR260301 administered as~          monotherapy (Part A) and in combination with vemurafenib (Part B) as well as~          vemurafenib PK in combination with SAR260301 (Part B)~        -  To evaluate food effect on SAR260301 PK (Part A)~        -  To assess preliminary antitumor activity according to Response Evaluation Criteria in~          Solid Tumors (RECIST 1.1 criteria).~        -  To assess preliminary antitumor activity using volumetric computed tomography (CT) or~          magnetic resonance imaging(MRI)~        -  To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor.~        -  To evaluate PK/PD relationships.~        -  To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib~          (RP2D) (Part B only)~        -  To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A~          (CYP3A) (Part A)~   "
105693|NCT01673724|"~     The purpose of this study is to determine whether pramipexole and bromocriptine are~     effective in the treatment of non-motor symptoms in Parkinson's Disease.~   "
105694|NCT01673711|"~     This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk~     for lung cancer. Studying samples of urine in the laboratory from smokers who are at high~     risk for lung cancer may help doctors learn more about biomarkers related to cancer.~   "
105695|NCT01673698|"~     The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific~     evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet~     and exercise in the treatment of obese subjects with one or more obesity-related comorbid~     conditions.~   "
105696|NCT01673685|"~     Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of~     daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea.~     State Government funding provides up to 4 oxygen cylinders to be delivered to patients~     requiring portable oxygen per month. However, the more active and motivated COPD patients~     often find these gratis supplies run out well before the month is up. Recent technology has~     developed battery powered portable oxygen concentrators. The latest models weigh less than a~     typical oxygen cylinder and have the advantage that the battery plug can be plugged into a~     car cigarette lighter outlet, or into the power point of any house. This means that the COPD~     patient has the potential to be far more mobile for far longer periods of time and visit~     friends almost infinitely by recharging the battery pack during the course of their travels.~     The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen~     cylinder. However, there is an upfront expense to these devices and inevitably a sound~     business case with cost considerations (amortization of the initial purchase price,~     recharging the battery costing the patient's electricity etc) needs consideration. Also,~     before assuming these devices are superior (or at least as good as) oxygen cylinders,~     because they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in~     bursts with each inspiration that is detected, unlike oxygen cylinders which can run~     continuously, one cannot assume without rigourous evaluation that mobility and quality of~     life necessarily is good or superior with the new devices. Hence, quality of life evaluation~     with emphasis on enjoyed activities by each COPD patient are essential as well as costing~     issues for the funding stakeholder (i.e. hospital site specific funds). Should a sound~     business case be made (i.e. improved quality of life with less costs over a longer period of~     time), then a sound justification can be made to funding bodies that COPD patients are~     better off and the funding body is shouldering less cost by wider usage of these devices~     following evaluation of this project. The design will be a randomised crossover such that~     COPD patients will spend one month on oxygen or battery powered concentrator devices and~     then switch over to the other oxygen delivery. Chronic Respiratory Questionnaire (Quality of~     Life) will be administered at the end of each month.~   "
105697|NCT01673672|"~     The purpose of this study is to assess the therapeutic potential and safety/tolerability of~     study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to~     severe allergic asthma not sufficiently controlled on current standard controller therapy.~      Altogether 360 patients randomized to 4 treatment groups will be included. The study~     compares three dose strength with placebo. Each patient receives 7 injections of study drug~     or undistinguishable placebo. Key outcome measures are patient reported parameters on their~     asthma.~   "
105698|NCT01673659|"~     The objectives of this study is to demonstrate bioequivalence (comparable safety and~     efficacy) of the Test product to the Reference in the treatment of subjects seasonal~     allergic rhinitis.~   "
105699|NCT01673646|"~     To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in~     Japanese patients with active acromegaly or pituitary gigantism. Primary objective is to~     assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <~     2.5 µg/L and the normalization of IGF-1 at 3 months of study treatment.~   "
105700|NCT01673633|"~     One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular~     involvement. Mostly involved joints in SSc were reported as wrist,~     carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little~     knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of~     this joint in SSc.~   "
105701|NCT01673620|"~     The purpose of this study is to assess the safety and tolerability of montelukast 10~     mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.~   "
105714|NCT01673438|"~     This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of~     aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles~     in subjects with advance solid tumors.~   "
105702|NCT01673607|"~     The immune response at primary tumor has a major role in the prognosis of colorectal cancer~     (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T cells at~     primary tumor greater than tumoral stage. There is no work in the literature that has~     examined the prognosis value of the immune response in liver metastases. To study immune~     cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge~     to understand the effectiveness of chemotherapy used in this situation.~      The chemotherapy used in liver metastases of colorectal cancer also have effects on~     non-tumoral liver tumor and therefore can interfere with postoperative complications of~     hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who received~     oxaliplatin before hepatectomy. Steatosis is frequently observed after administration of~     5-FU alone or in combination with irinotecan. This steatosis may also be accompanied by~     inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or~     irinotecan and is associated with increased postoperative mortality. The hepatic toxicity of~     new biological agents is not well known (cetuximab and bevacizumab). The mechanisms of~     chemotherapy-induced toxicities are currently unknown. The main objective is to analyze the~     profile of the immune response in liver metastases of CRC and find the link with the~     radiological response. Measurements will be made by quantitative RT-PCR on frozen liver~     biopsies. Secondary objective is to seek a correlation between the histological lesions~     induced by chemotherapy and non-invasive tests for liver fibrosis. The secondary endpoints~     are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free~     survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury,~     cytokines and circulating angiogenic factors.~   "
105703|NCT01673594|"~     The purpose of this study is to a) assess the efficacy of naltrexone in preventing~     stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere~     with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether~     naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We~     predict that naltrexone will successfully prevent stimulant-induced euphoria without~     interfering with the ability of stimulants to effectively treat ADHD in adults. This study~     will be an 8 -week trial with young adults (18-24) with ADHD.~   "
105704|NCT01673581|"~     This study will evaluate the usefulness of an informational website designed to educate~     patients with prostate cancer about their options for treatment. The investigators hope that~     this website will assist patients with making informed decisions about their care and~     improving their satisfaction with the treatments they choose.~   "
105705|NCT01673568|"~     Postoperative seroma formation is one of the most common complications after ventral hernia~     repair. Although some seromas may not have clinical impact, postoperative seroma formation~     often causes pain and discomfort and may even compromise wound healing. The use of~     postoperative abdominal binder is often recommended after ventral hernia repair to prevent~     seroma and diminish pain, but still with no scientific evidence. The primary aim of the~     present study is to investigate the effect of postoperative abdominal binders after~     laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life.~     Secondary, we register seroma formation.~      Method and material Randomized, controlled, multi-center, investigator-blinded study. A~     minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power~     calculations. Patients are randomized either to abdominal binder or no abdominal binder. The~     abdominal binder is worn from immediately after the operation and continuously for 7 days,~     night and day. Outcomes are based on patient self-reported registrations using Visual Analog~     Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to~     estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For~     secondary outcome we use ultrasound to measure the volume of seroma formation. We use~     Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test~     for pain, discomfort and quality of life for the effect of time on inter- and intragroup~     differences during the study period. P < 0.05 is considered significant.~   "
105706|NCT01673555|"~     This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP~     under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be~     evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid~     regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well~     as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with~     GSK1278863.~   "
105707|NCT01673542|"~     Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness~     of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the~     puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required~     for a 50% difference with the standard deviation of the control group, a significance level~     of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35~     patients per group.~      The expected benefit is the reduction of pain at the skin puncture during the realization of~     BAX.~      Improving professional practice and quality care~   "
105708|NCT01673529|"~     A two part, randomized, double-blind, placebo controlled study to investigate the effects of~     topical doses of SB705498 in healthy volunteers.~   "
105709|NCT01673516|"~     The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN)~     improves the control of blood pressure (BP) in patients with treatment-resistant~     hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters~     and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic~     management - IHM) during 6 months intensive treatment program (receiving antihypertensive~     care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to~     disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more~     rapidly than applying intensive medical therapy using IHM.~   "
105710|NCT01673503|"~     The purpose of this study is to compare visual acuity, safety, predictability, corneal~     biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive~     lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will~     randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the~     other.~   "
105711|NCT01673490|"~     Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90~     subjects will be enrolled so that among them at least 57 will complete the 6-month treatment~     period and evaluable for analysis.~      -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination~     therapy for six month in BPH patients by monitoring category, frequency and severity of~     adverse events encountered during the treatment period.~      -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin~     combination therapy with regard to symptom improvement in BPH patients by monitoring and~     analyzing of changes in IPSS and Qmax after 6 months of treatment.~   "
105877|NCT01671319|"~     The purpose of this study is to determine the feasibility of giving standard TC chemotherapy~     on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side~     effects.~   "
105718|NCT01673386|"~     This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride~     and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy~     for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score~     (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1~     of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week~     washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib~     hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment~     preference, as well as overall safety and tolerability, frequency of dose modifications and~     kidney-specific health outcomes/QoL.~   "
105719|NCT01673373|"~     The purpose of this trial is to test how well the iCAST™ RX Stent works in patients~     diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow~     by the stent will help to control blood pressure.~   "
105720|NCT01673360|"~     To monitor post-market performance through evaluation of short and long-term performance~     via:~        -  Efficacy~        -  Safety~        -  Patient reported outcomes~   "
105721|NCT01673347|"~     Using the concept of an implant acting as a spacer and stabilizer, the proposed study will~     evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of~     the great toe.~   "
105722|NCT01673334|"~     We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates~     of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic~     tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield~     than core biopsy.~   "
105723|NCT01673321|"~     This study compared the effects of dairy products, including milk and yogurt, with different~     amounts of proteins on responses of appetite, glucose and insulin and on food intake at a~     meal served 120 minutes later in healthy adult male individuals.~   "
105724|NCT01673308|"~     This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy~     for myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.~   "
105725|NCT01673295|"~     OBJECTIVE To test whether Rituximab (RTX) is efficacious to achieve complete renal response~     (CR) in Lupus Nephritis (LN) patients with persistent proteinuria (≥1g/d) despite at least 6~     months of standard of care (SOC).~      STUDY DESIGN Investigator-initiated randomized international open multicentric 104-week~     study.~   "
105726|NCT01673282|"~     This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in~     clinical practice and will also evaluate the subsequent change in the drug load of patients~     after addition of VIMPAT® to their treatment regimen.~   "
105727|NCT01673269|"~     When a doctor performs Endoscopic retrograde cholangiopancreatography ERCP (Endoscopy to~     examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The~     tube passes beyond the stomach and into an opening in the liver called the bile duct.~     Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the~     bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to~     take a sample from the bile duct. The purpose of our study is to examine wither performing~     this procedure can transmit bacteria from the bile duct to the main blood stream.~   "
105728|NCT01673256|"~     The objective of this study is to assess the atrial fibrillation (AF) episode detection when~     using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).~   "
105729|NCT01673243|"~     Little is known about what factors influence parental decisions to participate or to decline~     participation in tobacco trials offered in the pediatric clinical setting. Further, it is~     unclear what proportion of parents treated in our setting would elect to receive formal~     assistance with quitting smoking or consider alternative approaches that could facilitate~     eventual smoking cessation. While the recommendation to parents is generally to quit~     smoking, some may be unwilling or unable to quit and prefer more achievable alternative~     treatment goals. Some parent smokers may be unlikely to participate in an intervention aimed~     only at cessation but would be willing to participate in an intervention focused on~     establishing smoke-free environments for their child. Parents are typically not offered a~     choice regarding the type of intervention they receive and many interventions are not~     tailored to their readiness to quit smoking or designed to reach multiple family members in~     the home who may also smoke. Quitting smoking and establishing smoke-free homes and cars are~     distinct, yet challenging, goals for parents and families. Both approaches can directly, or~     indirectly, help parents to quit smoking, reduce the child's exposure to second-hand smoke~     (SHS), and initiate an important dialogue with families about tobacco control. How parental~     acceptability of smoking interventions is affected by the context of their child's treatment~     for cancer or SCD, as well as survivorship, warrants further study.~   "
105730|NCT01673230|"~     Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when~     pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires~     adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices~     of a response to fluid challenge may allow an earlier hemodynamic optimization, which has~     not been showed until now when LVEF is altered.~   "
105731|NCT01673217|"~     This phase I trial is studying the side effects and best dose of decitabine when given~     together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating~     patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal~     cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may~     help the body build an effective immune response to kill tumor cells. Giving combination~     chemotherapy together with vaccine therapy may kill more tumor cells~   "
105790|NCT01672450|"~     This is a single center, open phase I dose escalation study. This study will assess the~     highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2~     (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous,~     subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the~     drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the~     combination.~   "
107778|NCT01645735|"~     The purpose of this study is to determine whether ceftaroline is effective and safe for the~     treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for~     infection due to Methicillin-resistant Staphylococcus aureus (MRSA).~   "
105732|NCT01673204|"~     Worldwide, the most common cause of chronic kidney disease (CKD) and end stage renal disease~     (ESRD) is diabetes. Unlike the past, in south korea, diabetes account for more than 40% of~     ESRD. According to WHO reports in 1998, 100 million people had type 2 diabetes in 1997, and~     there is expected to increase by 300 million people in 2025. In addition, the expected~     survival time of patients with diabetes increase compared to previous. In the future, ESRD~     due to type 2 diabetes is expected to have a significant impact on the health industry.~     Therefore, prevention of progression to CKD and ESRD in diabetic patients is important to~     aspect of national health and economic problems. How to stop the progression of diabetic~     nephropathy is part of modern medicine to be solved.~      Strict glycemic control, blood pressure regulation, and use of renin-angiotensin system~     (RAS) blockers inhibit the development and progression of diabetic nephropathy.~     Microalbuminuria in diabetic patients has been recognized as a predictor of progression of~     diabetic nephropathy. Thus, the prevention of elevated urinary albumin excretion is an~     important therapeutic target for the prevention of renal and cardiovascular events.~      In patients with diabetes and hypertension, the drugs that block the RAS are used to treat~     proteinuria, but still a large number of patients with proteinuria are uncontrolled. In~     addition, ACE inhibitors or ARB agents actually have a limited effect on reducing the risk~     of cardiovascular or renal outcome. Also, sulodexide or pentoxyphylline which is reducing~     proteinuria have some weak evidence in terms of efficacy and safety. Therefore, the~     introduction of new alternative drugs are required.~      Already several study reported that calcitriol or paricalcitol in the renal injury model~     have renopreventive effect. In addition, in diabetic renal injury mice model reported that~     vitamin D receptor deficiency leads to glomerulosclerosis. Inhibition of the RAS with~     combination of paricalcitol and RAS inhibitors effectively prevent renal injury in diabetic~     nephropathy. Recently, Dick de Zeeuw et al reported that addition of paricalcitol to RAS~     inhibition safely lower residual albuminuria in patients with diabetic nephropathy. Recent~     studies reported that elevated concentrations of serum markers of the TNFα and Fas-pathways~     are strongly associated with decreased renal function in diabetic patients. However, the~     role of these markers in early progressive renal function decline are not clear. Therefore,~     the objective of this study is to identify the renoprotective effect as an new treatment of~     activated vitamin D (Calcitriol) indicating the TNF-α-related anti-inflammatory action and~     to seek the role as an important biomarker that the changes of TNFR in diabetic nephropathy~     can predict response to treatment.~   "
105733|NCT01673191|"~     There is a need to find an effective therapy for diabetic patients who develop macular edema~     after cataract surgery. The objective of this study is to assess the safety and efficacy of~     the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular~     edema after cataract surgery.~   "
105734|NCT01673178|"~     This is a trial in obese subjects who have poor lipid control with and without Type 2~     diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses~     of PF-05231023~   "
105735|NCT01673165|"~     The purpose of this study is to determine if the use of fortified skimmed mother's milk is a~     safe alternative to specialized formula in the treatment of chylothorax following~     cardiothoracic surgery.~   "
105736|NCT01673152|"~     This study is designed to assess the effect of oligofructose administration for 12 weeks on~     Body Mass Index (BMI) of overweight and obese children.~   "
105737|NCT01673139|"~     This is a substudy of Generation 100. The investigators will follow the persons with~     atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of~     atrial fibrillation, symptoms, use of health services or echocardiographic findings.~   "
105738|NCT01673126|"~     Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied~     to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory~     and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery~     Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of~     consciousness in a double-blind sham-controlled experimental design.~   "
105739|NCT01673113|"~     Cryolipolysis with Zeltiq CoolSculpting device is a novel method of non-invasive fat~     removal. The technique works by application of cold plates to the skin surface for a single~     cooling cycle lasting 60 minutes, after which a cold-induced inflammatory panniculitis leads~     to selective loss of fat. There is no histologic evidence of necrotic or inflammatory damage~     to skin or nerves, however a single small human study has reported prolonged temporary~     altered sensation (hypoesthesia) in the area of cryolipolysis procedure. This hypoesthesia~     seen in about 2/3 of patients, is completely reversible, lasts up to 8 weeks after~     treatment, and suggests that cooling under these conditions can temporarily alter sensory~     nerve function.~      The purpose of this study is to further characterize the reversible cutaneous sensory~     function alteration after cryolipolysis with Zeltiq CoolSculpting device. Using multiple~     modalities of sensory nerve function we hope to elucidate the details of cryolipolysis~     induced sensory nerve alteration.~   "
105740|NCT01673100|"~     The purpose of this study is to test the feasibility of using targeted daily cell phone~     interaction to facilitate behavior change for physical activity in previously-sedentary~     individuals who have recently undergone a percutaneous coronary intervention (PCI).~   "
105741|NCT01673087|"~     Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient~     way to evaluate the biological impact of day-to-day stressors that people encounter as they~     go about their lives, since saliva is so easy to collect. However, the biological meaning of~     saliva cortisol measures has never been carefully examined. The goal of this study is to~     collect saliva from a large group of people as they go about their every-day lives, to~     measure their cortisol levels, and then study them in the laboratory where Investigators can~     learn more about how their stress response system (which produces cortisol) is really~     functioning. Investigators can then determine much more precisely what saliva cortisol~     levels really mean in terms of stress system biology. This will allow investigators to~     obtain much more useful information from the next decade of research on naturalistic stress~     and its biological impact using saliva cortisol measures, helping investigators to~     understand how stress undermines health and how to combat this effect.~   "
105742|NCT01673074|"~     The primary objective of the study is to determine the maximally tolerated photodynamic~     therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with~     pleural malignancy who have undergone a maximal resection.~   "
105796|NCT01672372|"~     The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to~     evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress~     B™) for improving depressive and anxiety symptoms according to the Beck Depression and~     Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major~     depression or other forms of depressive disorders and an elevated level of homocysteine (>~     10 µmol/L) at baseline. Secondary outcomes will include anthropometrics for body~     composition, blood pressure and pulse, level of physical activity, dietary intake, and~     quality of life. Participants will be assessed at baseline and 30 and 60 days. The study~     will consist of two treatment arms: (a) vitamin B complex nutritional supplement and (b)~     placebo.~      The information obtained in this study will help in determining the efficacy of using~     nutritional supplements for improving the outcomes of people with depression.~   "
105743|NCT01673061|"~     Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a~     frequent reason for emergency department visits. The only proven cure for abscesses is~     cutting them open and allowing the infection to drain, but this procedure is often painful.~     Currently, the usual method of pain control is to inject a numbing medication (lidocaine)~     into the site, but this injection itself is often painful and sometimes does not offer full~     pain relief. Although there has been some research into the use of non-injected numbing~     agents as another option, no studies have looked at the use of numbing sprays (vapocoolant)~     in this context specifically. The hypothesis of this study is that numbing spray is as good~     as injected numbing medication at relieving pain in patients having small abscesses opened~     and drained. This theory will be tested by taking two groups of patients having small~     abscesses drained in the Emergency Department, and assigning one group to get a numbing~     injection, and the other to get a numbing spray. Their levels of pain and satisfaction will~     be recorded before, during, and after the procedure, and the two groups will be compared.~   "
105744|NCT01673048|"~     Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced~     diaphyseal femoral fractures in children. However, some literature report high complication~     rates (10-50%) in complex fractures. Data of our own patients with special emphasis on~     complications showed also mediocre results. Thus, a biomechanical study was conducted to~     search for modifications. In this study the stiffness with a 3rd nail implanted was compared~     to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde~     ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral~     fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd~     from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).~     Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression~     (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal~     rotation and 9° compression directions implantation of 3 nails became standard treatment for~     all dislocated femoral fractures at our department.~      All patients were followed prospectively. The following data was collected: Type of~     osteosynthesis, any kind of complication (additional procedures like cast or external~     fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time~     until full weight bearing and time until implant removal. At follow-up the legs were~     controlled for a possible length discrepancy and a possible deviation of axis. Patients`~     satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further~     on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1~     and 3-4 months (dependend on age).~      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,~     fracture, femur, treatment, children, adolescents.~   "
105745|NCT01673035|"~     Background~      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with~     functional disability. Cognitive behavior therapy (CBT) and behavioral stress management~     (BSM) have been showed to be effective in the treatment of severe health anxiety. The~     mechanisms of the treatments are however poorly understood. In addition, effective~     psychological treatments are accessible to only a few. One prior RCT has shown that~     internet-based CBT could be effective in comparison to waiting list controls. More studies~     on internet-based CBT is essential to establish evidence. In addition, few studies with~     sufficient power have investigated the effect of CBT in comparison to other active~     treatments.~      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to~     behavioral stress management (n=110) for adult participants with severe health anxiety. BSM~     is considered a comparison treatment for two reasons: it has been shown to be effective and~     it lacks exposure and response prevention, which is suggested to be an important mechanism~     in CBT.~      Participants in both treatments are expected to be significantly improved on measures of~     health anxiety. Participants receiving CBT are expected to be significantly more improved~     compared to participants receiving BSM.~   "
105746|NCT01673022|"~     Description:~      This is a multi-institutional study investigating the sensitivity and negative predictive~     value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after~     cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or~     cervical cancer at the time of their robotic surgical staging.~      Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed~     by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel~     lymph nodes identified will be removed and sent for ultraprocessing by pathology. The~     non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and~     sent for routine pathologic processing according to standard of care for these surgical~     procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated~     for sensitivity and negative predictive value in their ability to detect metastatic disease.~   "
105747|NCT01673009|"~     THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients~     with plexiform neurofibromas~   "
105748|NCT01672996|"~     To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To~     evaluate the safety and tolerability of low concentration Ioforminol Injections. Study~     recruits healthy volunteers.~   "
105749|NCT01672983|"~     This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of~     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as~     ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)~     or genotype 2 (HCV GT2) infection who were previous treated with pegylated~     interferon/ribavirin (pegIFN/RBV).~   "
105750|NCT01672970|"~     This multi-center observational study will evaluate the use of RoActemra/Actemra~     (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on~     RoActemra/Actemra treatment according to the local label will be followed for 6 months.~   "
105751|NCT01672957|"~     This observational study will evaluate renal function in participants who underwent renal~     allograft transplantation and are started on combined immunosuppressive treatment containing~     mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months~     following transplantation.~   "
105752|NCT01672944|"~     The purpose of this study is to evaluate English and Spanish language educational materials~     that inform the community about a type of cancer research that involves the collection,~     storage, and processing of biospecimens. Part A of this study involved creating surveys~     about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin~     to evaluate education materials about biospecimen donation and research.~      Phase II consists of two independent randomized controlled trials. Each trial is being~     conducted independently to test English and Spanish language materials (75 subjects each).~   "
105753|NCT01672931|"~     We believe that there is an association between BMI and oocyte diameter in women undergoing~     IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF.~     One group will have BMI 20-25 and the other group will have BMI above 30.~   "
105754|NCT01672918|"~     Background:~      - Autoimmune lymphoproliferative syndrome (ALPS) is a genetic disorder of the lymph system.~     People with ALPS often have swollen lymph nodes, especially in the neck and armpit. They~     also have a much higher risk of developing lymphoma. It is not always easy to determine~     whether the swollen lymph nodes are caused by ALPS or by lymphoma. Researchers want to see~     whether different imaging studies can show the difference between ALPS and lymphoma. The~     studies used will be positron emission tomography (PET) and computed tomography (CT).~     Researchers will use a drug called fluorodeoxyglucose (FDG) to look at the lymph nodes.~      Objectives:~      - To see how well imaging studies can distinguish between swollen lymph nodes caused by ALPS~     or by lymphoma.~      Eligibility:~        -  Individuals must be 5 years of age or older and enrolled on the National Institutes of~          Health natural history study of ALPS.~        -  Participants should either have lymphoma or have symptoms that suggest possible~          lymphoma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an FDG-PET/CT scan. It will be performed according to standard~          procedures.~        -  If the results of the scan do not show lymphoma, participants will stay on the study~          for 1 year for clinical follow up. They may have a second FDG-PET/CT scan if there is a~          change in symptoms. Such changes include further enlargement of lymph nodes,~          unexplained fevers, or weight loss.~        -  If the results of the scan show evidence of new or worsening lymphoma, treatment on~          this study will end. Further tests based on clinical symptoms, including a lymph node~          biopsy, may be done under the ALPS natural history study to rule out or make a~          diagnosis of lymphoma.~   "
105755|NCT01672905|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in~     samples from patients treated for prostate cancer on trial ECOG-E9802.~   "
105756|NCT01672892|"~     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill~     tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly~     to the tumor may kill more tumor cells and cause less damage to normal tissue.~      PURPOSE: This randomized phase III trial is studying two different methods of radiation and~     their side effects and comparing how well they work in treating endometrial and cervical~     cancer after surgery.~   "
105757|NCT01672879|"~     This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with~     compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2~     phases:~        -  Randomized Double-Blind Phase~        -  Open Label Phase (optional)~   "
105758|NCT01672866|"~     This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective~     at preventing the histologic progression of liver fibrosis and the clinical progression to~     cirrhosis in participants with non-alcoholic steatohepatitis (NASH).~      It will consist of 2 phases:~        -  Randomized Double-Blind Phase~        -  Open Label Phase (optional)~   "
105759|NCT01672853|"~     The purpose of this study is to evaluate whether Simtuzumab (GS-6624) is effective at~     preventing the progression of liver fibrosis in subjects with PSC.~   "
105760|NCT01672840|"~     The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of~     cocoa-containing product consumption over an 8-week period and assess effects on blood~     pressure, endothelial function and arterial stiffness. The randomized, controlled, modified~     Latin square parallel design will compare the effects of two doses of cocoa consumption on~     blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1~     hypertension.~   "
105761|NCT01672827|"~     To Evaluate the Effectiveness of an Electronic Training Program for Orienting and~     Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.~   "
105762|NCT01672814|"~     This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure,~     also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen~     crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in~     patients with keratoconus.~   "
105763|NCT01672801|"~     The main purpose of this study is to test the effectiveness of nimodipine in preventing a~     luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene~     citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation~     to allow adequate recruitment of follicles, proper maturation of a dominant follicle before~     ovulation, and effectively time insemination with semen to allow fertilization of a mature~     egg to occur.~      The investigators are also conducting this study to determine medication side effect profile~     (including lightheadedness or dizziness from low blood pressure or rapid heart rate,~     headache, and nausea), patient treatment compliance, and clinical pregnancy (positive~     pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle~     stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on~     these hormones.~      As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of~     gonadotropin releasing hormone in animal and preliminary human studies. The investigators~     hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge~     during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients~     undergoing assisted reproduction with intrauterine insemination (IUI).~   "
105764|NCT01672788|"~     The primary objective of this trial is to establish bioequivalence of two FDC tablets and~     the single tablets when administered together after a high fat high caloric meal.~   "
105765|NCT01672775|"~     The purpose of this study is to evaluate the safety and pharmacokinetics and assess the~     immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).~   "
105766|NCT01672762|"~     This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to~     diabetic patients.~   "
105767|NCT01672749|"~     The foremost challenge when managing early onset scoliosis (curve deformity before the age~     of 10) is to prevent curve progression while maintaining growth of the spine. Current~     treatment options require repetitive interventions as the spine and the child grow. This~     study will compare two techniques of growth modulation: Standard dual growing rods versus~     the new Luqué Trolley screws~      Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer~     re-operations after 3 years of follow-up (FU) than patients included in the comparison group~   "
105768|NCT01672736|"~     This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487~     (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation~     of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined~     with bortezomib and dexamethasone at the MTD to establish the ORR. This trial will accrue~     patients with relapsed or relapsed/refractory MM - a disease state for which bortezomib is~     approved to treat by the FDA and Health Canada. The combination of ASP7487 (OSI-906) with~     bortezomib is supported by pre-clinical work in MM in which the combination with an IGF1-R~     inhibitor enhances anti-tumor activity of bortezomib.~   "
105769|NCT01672723|"~     From birth we rely on others for comfort and care and derive pleasure from being together.~     Research from the fields of health psychology, social psychology, and public health converge~     to highlight the importance of having and maintaining good relationships for overall health.~     Indeed, having close friends and family and feeling connected to them has been called a~     basic need, similar to our need for food and water. It may not be a coincidence then that~     feelings of connection rely on similar systems in the body as other needs that are both~     basic and highly pleasing and rewarding. For instance, its possible that opioids, a~     substance in the body associated with pleasant, euphoric feelings, may also be important for~     connecting with others. This study will examine the role of opioids in feeling connected to~     others by administering a drug called naltrexone, that effects opioid processing in the~     body, on perceptions and feelings toward a number of tasks in the lab. Additionally, to~     assess the effects of naltrexone outside of the lab, participants will complete daily diary~     responses via text and online surveys.~      40 participants will take both placebo and naltrexone. Participants will complete two~     sessions, one in each drug condition, in which they complete a number of tasks including~     reading messages on a computer screen, holding a number of objects, and viewing images while~     undergoing electric shocks. Participants will also complete a daily diary for 14 days while~     on naltrexone and placebo. Prior to these lab sessions participants will be screened at~     UCLA's Clinical & Translational Research Center (CTRC) to ensure that they are healthy and~     that it is safe for them to take the study drug.~      We hypothesize that people will report feeling less socially connected when on naltrexone~     compared to placebo and will show subsequent changes in social behavior outside of the lab.~   "
105770|NCT01672710|"~     Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is~     characterized by persistent memory and concentration problems, headaches, fatigue and muscle~     and joint pain. It is not known what causes the illness, but exposure to chemicals is~     suspected. The Hubbard detoxification program consists of exercise and sauna therapy~     together with administration of several dietary supplements, particularly crystalline niacin~     used at increasing concentrations over a period of about four weeks. The investigators~     hypothesize that this program will reduce symptoms, as tested by administration of cognitive~     and quality of life tests and serum clinical chemistry tests.~   "
105771|NCT01672697|"~     Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT)~     in the post-partum period after a vaginal delivery complicated by genital trauma help to~     improve a woman's quality of life, specifically in regard to anal incontinence. To be able~     to study this, the investigators need to know how well the muscles of a woman's pelvic floor~     function after a vaginal delivery and this requires measuring their strength during a pelvic~     exam. At present, there are no studies that have looked at whether the intervention of PT/BT~     improves a woman's anal incontinence quality of life after sustaining genital trauma during~     vaginal deliveries~   "
105772|NCT01672684|"~     This randomized phase I trial studies at-home group video calling sessions in quality of~     life in rural patients with breast cancer. At-home group video calling support sessions may~     improve the well-being and quality of life of women who have breast cancer~   "
105773|NCT01672671|"~     The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy~     in correlation with BRCA1-associated DNA repair dysfunction in patients with early triple~     negative breast cancer.~   "
105774|NCT01672658|"~     The goal of this clinical research study at RIC is to determine the value and benefit of the~     SK multimodal balance training system through independent clinical evaluations. The~     functional benefit of the SK Balance system will be measured by any improvements in balance~     and functional assessments.~      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II~     Small Business Innovation Research by the Department of Defense.~      3) Hypotheses & Research Objectives and Purpose:~      The specific research questions to be addressed are:~        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT~          intervention on balance and functional gait measures in mild traumatic brain injury~          (mTBI) participants.~        2. How do SKBS measurement tools compare to standard clinical assessments of gait and~          balance in mTBI patients The purpose of this clinical research study is to compare the~          value and benefit of the SK multimodal balance training system in combination with~          traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone~          through independent clinical evaluations. The functional benefit of the SK Balance~          system will be measured by any improvements in clinical measures of balance, functional~          mobility, and gait assessment.~   "
105775|NCT01672645|"~     The purpose of this study is to determine the safety and tolerability of multiple doses of~     PF-05402536 and PF-06413367 in healthy adult smokers.~   "
105776|NCT01672632|"~     It has been shown that large fat cells are associated with more risks for insulin resistance~     and more cardiovascular risk factors such as high cholesterol or triglycerides.~   "
105777|NCT01672619|"~     Being the craniostenoses sutural basically a disease, the fact that the brain being trapped~     in an enclosure that does not have complacency required to accompany their growth~     constitutes the challenge of treatment, which aims to restore the complacency of the suture~     and correct the stenotic compensatory cranial deformity.~      This paper proposes the combination of a helicoid osteotomy distraction osteogenesis~     provided by the use of springs distracting.~   "
105778|NCT01672606|"~     This study describe the effect of partial neuromuscular blockade of rocuronium on the acute~     hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP~     treatment.~   "
105779|NCT01672593|"~     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of~     low-output ECFs. The primary objectives of this study are to compare the clinical efficacy,~     safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin~     sealant Bioseal® in the management of patients with low-output volume ECFs.~   "
105797|NCT01672359|"~     A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC~     Synergy® and Catalyn® on cognitive and immune function markers and quality of life among~     healthy older adults with no history of significant cognitive deficits~   "
105798|NCT01672346|"~     In this prospective randomized study, we aim to compare the rate of PV reconnection~     following PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant~     PV conduction will be unmasked by adenosine-provocation.~   "
105799|NCT01672333|"~     Early stage diagnosis of gastric cancer has ensued different approaches in its resection~     strategies. In order to increase the proportion of cases that undergo radical resection and~     reduce the recurrence rate, different pre-operative treatments are introduced. Here, the~     investigators investigate an active preoperative chemotherapeutic regimen to in patients~     with locally advanced gastric cancer.~   "
109121|NCT01627938|"~     This study will primarily address the question whether the combination of Mitoxantrone~     therapy with dexrazoxane can reduce cardiotoxic side effects in the treatment of Multiple~     Sclerosis patients in comparison to Mitoxantrone monotherapy.~   "
105780|NCT01672580|"~     This project will examine the spread of health interventions with a randomized control trial~     design by introducing public health interventions in 32 villages in the Honduran Department~     of Lempira. Based on identified public health needs in the region, namely improved drinking~     water and diet, this study will provide training on the use of chlorine (sodium~     hypochlorite) for water purification and multivitamins for nutritional supplementation. In~     some villages, individuals selected for their social connectedness will be trained and given~     coupons that can be redeemed for either chlorine bleach or multivitamins, and these persons~     will be asked to spread this information and distribute coupons to four people of their~     choosing. In other villages, individuals selected at random will receive the same training,~     materials, and instructions. A second wave of coupon distribution will provide coupons to~     those who received a coupon from the original seed groups so that they may disperse these~     coupons further out in the social networks. Over the following months, study investigators~     will look at how knowledge of these health practices, and uptake or and adherence to the~     practices, spreads throughout the villages.~      More specifically, the investigators will examine the speed and extent of spreading of these~     new health practices after introducing them to three different initial seed groups: (1)~     people chosen on the basis of being named as a friend by many people in their village, (2)~     people chosen based on being named as a friend by a randomly chosen individual, and (3) a~     group of randomly chosen individuals. It is hypothesized that spread will occur faster~     and/or to a greater extent when the intervention is started in groups 1 and 2 versus group 3~     (control group).~   "
105781|NCT01672567|"~     The purpose of this study is to determine the effects of daily consumption of eggs or egg~     substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in~     participants with clinically established coronary heart disease (CHD).~   "
105782|NCT01672554|"~     This research will explore whether Quetiapine XR used primarily to treat psychosis may also~     cover for comorbid anxiety disorder and offer advantages in patients with schizophrenia and~     comorboid anxiety disorder. Preliminary data on pharmacological properties of Quetiapine and~     its metabolites and intuitive impression from our clinical experience lead to believe that~     Seroquel XR use in monotherapy may offer advantages over other antipsychotics in treating~     co-morbid anxiety disorder in patients suffering from schizophrenia. This open label switch~     study conducted in a schizophrenic population intends to verify this hypothesis.~   "
105783|NCT01672541|"~     The Dating Matters: Strategies to Promote Healthy Teen Relationships Initiative intends to~     promote respectful, nonviolent dating relationships among adolescents living in high-risk,~     urban communities. CDC has developed a comprehensive approach to promoting respectful,~     non-violent relationships based on current evidence based and evidence informed strategies.~     This comprehensive approach includes: school-based curricula for 6th, 7th, and 8th grade~     students; separate parent programs for parents of 6th, 7th, and 8th grade students; a~     communications campaign involving social media and near-peer brand ambassadors; an online~     training about dating violence for educators; policy assessment at the school or community~     level; and development and validation of school and community level indicators of teen~     dating violence. Additionally, schools assigned to the comprehensive condition will also~     receive intensive training and technical assistance to support implementation of these~     components. Among 4 U.S. sites, 44 schools will be randomly assigned to implement either the~     Dating Matters comprehensive approach or the standard of care approach, which we are~     operationalizing as Safe Dates, a an evidence based student curriculum for 8th graders. We~     hypothesize that the comprehensive approach will be more effective than the standard~     approach at preventing the perpetration and victimization of teen dating violence over time~     and at promoting positive relationship behaviors over time.~   "
105784|NCT01672528|"~     A multicentre, prospective observational study to develop, evaluate and validate Patient~     Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic~     cardiac arrhythmias~   "
105785|NCT01672515|"~     Stroke is one of the three leading causes of human death, and a major cause of adult~     disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent~     cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce~     infarct size of cerebral infarction. Investigators hypothesized that postconditioning would~     reduce infarct volume of ischemic stroke patients.~   "
105786|NCT01672502|"~     Firefighters frequently work extended duration shifts and long work weeks which have adverse~     effects on alertness, health, safety and performance. This protocol uses a survey instrument~     to examine the effects of extended duration shifts on safety outcomes (e.g., motor vehicle~     crashes, accidents, injuries), health (e.g., diagnosis and treatment of sleep disorders,~     improved general health indices, decreased number of sick days), and performance (e.g.,~     decreased response time). This study will expand understanding of the nature, scope,~     etiology and consequences of firefighter fatigue and increase our ability to develop~     guidelines that can be generalized across fire departments throughout North America. This~     study could provide an avenue to make lasting policy improvements that could enhance the~     safety, health, and performance of firefighters.~   "
105787|NCT01672489|"~     The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers~     using objective measures of drowsiness and driving performance in an instrumented research~     vehicle.~   "
105788|NCT01672476|"~     A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive~     Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with~     Mild to Moderate Essential Hypertension~   "
105789|NCT01672463|"~     This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot~     cohort of human recurrent malignant glioma patients. All patients will have been previously~     treated with the standard-of-care treatment which includes surgical resection, radiation and~     chemotherapy, and in some cases treatment for recurrent disease with investigational agents~     or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater)~     established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine~     pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007~     treatment on this protocol.~   "
105878|NCT01671306|"~     Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral~     development in non-diabetic patients with stable coronary artery disease. Our aim in this~     study is to find out any possible relationship between the levels of circulating monocyte~     subsets and coronary collateral development in type 2 diabetic patients.~   "
105791|NCT01672437|"~     The Danish regions aim to implement antenatal education in small groups for all expectant~     parents. The effects of general antenatal education for childbirth or parenthood, or both,~     remain largely unknown. Also it is unknown if antenatal education in small groups is~     superior to antenatal lectures which is currently standard care.~      The aim of the trial is to evaluate if antenatal birth and parent preparation in small~     groups can increase parenting resources thereby easing birth and creating a smoother and~     less stressful transition to parenthood among the participants, compared to those allocated~     to standard care. This in turn is hypothesized to improve health and thriving among newborn~     families and affect their use of healthcare services. A thorough process evaluation will be~     conducted highlighting enabling factors and barriers to the implementation. Finally~     cost-effectiveness analysis will be conducted.~      Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the~     Copenhagen Capital Region of Denmark.~      Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due~     to give birth at Hvidovre Hospital. Being legally able and willing to provide signed~     consent, and being fluent in Danish.~      Women are randomised to receive:~        1. A research-based birth and parenting program. The intervention consists of 4 sessions~          in small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of~          gestation, and a post-natal session 5 weeks after expected due date.~        2. Standard care (control group). The pregnant woman and her partner are offered two~          antenatal lectures in an auditorium.~      The allocation of participants to the intervention will be 1:1 to the intervention and the~     control group.~      Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks~     post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric~     database, and via the national registers. Analyses will be intention to treat. Subgroup~     analysis will be conducted in relation to personal and demographic characteristics. Process~     evaluation will be conducted using questionnaires and qualitative interviews. The~     incremental societal cost of the intervention will be computed and compared to the measured~     outcomes in a cost-effectiveness analysis.~      Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,~     use of health care services, self-efficacy, divorce.~   "
105792|NCT01672424|"~     Hypothesis: The volume of gastric contents will be the same for a high protein drink versus~     ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring~     parturient.~      Specific Aim: To determine the volume of gastric contents at various time intervals (every~     20 minutes for 2 hours) in patients with an epidural that are given a high protein drink~     versus those that are given ice chips, with ultrasound.~   "
105793|NCT01672411|"~     In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate~     of 214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests~     have been developed in order to identify PCa while it is still confined to the prostate~     gland.~      The two most commonly used tests are digital rectal examination and serum prostate-specific~     antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for~     PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its~     levels may change as result of physical activity, sexual activity, in the presence of benign~     prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of~     PCa.~      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering~     prostate biopsy and large programs for the early detection of prostate cancer have shown~     that almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However,~     using a PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected~     (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for~     identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;~     moreover, the levels of free and bound PSA have been assessed, together with PSA density~     (the rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase),~     which seem to have some validity for detecting prostate cancer.~      Recent studies have shown that other new biomarkers could be used in the diagnosis of early~     prostate cancer as they showed a higher sensitivity and specificity. In the last two years,~     several investigators showed that PSA isoform [−2] proPSA (p2PSA) and its derivatives,~     namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA~     / free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA~     (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to~     PCa aggressiveness at biopsy.~      The aim of this study is to confirm the diagnostic and prognostic predictive value of~     prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index~     in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.~   "
105794|NCT01672398|"~     Background: Patients hospitalized with complex chronic conditions frequently experience~     preventable short-term readmissions due to inadequate transition support. Although~     structured discharge planning with telephone follow-up improves transition outcomes, these~     services often are unavailable, and proactive outreach is often inadequate once the patient~     returns home. Informal caregivers are invaluable for ensuring successful transitions, but~     many patients live alone, have an in-home caregiver who is struggling with competing~     demands, or live at a distance from adult children or other potential sources of support.~     New models are needed for transition support that include low-cost technologies and more~     structured assistance for patients' informal caregiving network, while providing patients'~     clinical teams with the information they need to avert health crises.~      Objectives: Consistent with Agency for Healthcare Research and Quality goals to improve~     transitions using accessible health IT, we will evaluate a novel intervention designed to~     improve the effectiveness of transition support for common chronic conditions via three~     mechanisms of action: (a) direct tailored communication to patients via automated calls post~     discharge, (b) support for informal caregivers via structured feedback about the patient's~     status and advice about how they can help, and (c) support for proactive care management~     including a web-based disease management tool, automated alerts about potential problems,~     and the capacity for asynchronous communication with patients and their caregivers.~     Specifically, the trial will determine: 1) whether the CarePartner intervention improves~     patients' readmission risk and functional status; 2) the impact of the intervention on~     patients' self-care behaviors and the quality of the transition process; and 3) whether the~     intervention improves caregiver burden and stress levels.~   "
105795|NCT01672385|"~     Background: Older hospitalized adults frequently experience preventable short-term~     readmissions due to inadequate transition support. Although proactive telephone follow-up~     improves transition outcomes, these services often are unsystematic and of low intensity.~     Informal caregivers are invaluable for ensuring successful transitions, but many patients~     live alone, have an in-home caregiver who is struggling with competing demands, or live at a~     distance from adult children or other potential sources of support. New models are needed~     for transition support that include low-cost technologies and more structured assistance for~     patients' informal caregiving network, while providing patients' clinical teams with the~     information they need to avert health crises.~      Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a~     novel intervention designed to improve the effectiveness of transition support for older~     adults with common chronic conditions via three mechanisms of action: (a) direct tailored~     communication to patients via regular automated calls post discharge, (b) support for~     informal caregivers living outside of the patient's household via structured feedback about~     the patient's status and advice about how they can help, and (c) support for proactive care~     management including a web-based disease management tool, automated alerts about potential~     problems, and the capacity for asynchronous communication with patients and their~     caregivers. Specifically, the trial will determine: 1) whether the CarePartner intervention~     improves patients' readmission risk and functional status; 2) the impact of the intervention~     on patients' self-care behaviors and the quality of the transition process; and 3) whether~     the intervention improves caregiver burden and stress levels.~   "
105800|NCT01672320|"~     The objectives of this study are to evaluate the clinical value of robotic-assisted total~     hip arthroplasty with respect to acetabular cup implantation, and to document the long-term~     clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be~     obtained at every study site to evaluate the basic clinical outcomes and post-operative~     component placement accuracy of each MAKO® THA patient.~      The hypothesis is that robotic preparation of the acetabulum will significantly reduce the~     variability and inaccuracy in the component alignment parameters that lead to post-operative~     complications, including implant failure.~   "
105801|NCT01672307|"~     The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of~     eyebrows.~   "
105802|NCT01672294|"~     Informal caregivers provide a majority of care for patients at the end of life. Lack of end~     of life preparation and completion may leave caregivers less capable of caring for a loved~     one or making crucial decisions influencing care.~      This study will examine whether a preparation and completion intervention reduces caregiver~     anxiety, depression, anticipatory grief, and burden and improves patient quality of life and~     health care use~   "
105803|NCT01672281|"~     In endurance sports competitions such as cycling, an athlete's capacity to sustain~     submaximum power (i.e. endurance capacity) strongly influences overall race performance.~     Endurance capacity can be increased by both long, continuous endurance exercise at moderate~     oxygen consumption, and high-intensity (at or above peak oxygen consumption) interval~     training. However, it has also been shown that resistance exercise, if performed in addition~     to endurance exercise, can further enhance endurance capacity. The investigators have~     recently described a novel training method, which is based on combined vibration and~     resistance training and superimposed vascular occlusion. Based on the investigators previous~     results showing that this type of training leads to marked increases in endurance capacity~     in previously untrained young women, the investigators aim at investigating whether the~     method is also effective in increasing endurance capacity in highly endurance-trained young~     men, and whether the method leads to bigger improvements relative to resistance exercise~     alone. Besides the functional outcomes the investigators are also interested in the~     specificity of the cellular adaptations with respect to the two trainings methods.~   "
105804|NCT01672268|"~     This is a pilot prospective, comparative, monocentric, randomized study with 2 groups.~     People with a severe aortic stenosis and a high risk of surgery are referred to a Trans~     catheter aortic valve implantation (TAVI).~   "
105805|NCT01672255|"~     Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote~     weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and~     HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by~     diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory~     has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an~     important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are~     significantly reduced in Type 1 DM and are further blunted by antecedent episodes of~     hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses~     during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained.~     Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge.~     Generally, serotonergic pathways are inhibitory but both single and longer term~     administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been~     demonstrated to increase basal epinephrine levels and enhance baroreflex control of~     Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also~     enhance SNS responses and also override the large ANS sexual dimorphism present during sub~     maximal exercise. Therefore, the purpose of this study is to determine if the SSRI~     fluoxetine (Prozac) can improve SNS responses during exercise.~   "
105806|NCT01672242|"~     Respiratory distress is a common problem in an intensive care unit. There are multiple~     mechanisms that are used to help patients who are in respiratory distress including~     mechanical ventilation, continuous positive airway pressure (CPAP), bilevel positive airway~     pressure (BiPAP), high flow oxygen, and oxygen supplementation through nasal cannula or a~     facemask.~      The purpose of this study is to evaluate the mechanism by which Vapotherm, a high flow~     oxygen system, provides breathing support. Vapotherm provides high flow oxygen at different~     flow rates, meaning one can increase the amount of oxygen flow to help with breathing~     support. The investigators believe that this high flow oxygen system may provide similar~     breathing support that a continuous positive airway pressure machine (CPAP) machine does.~   "
105807|NCT01672229|"~     This study will investigate whether bortezomib can control the immune system and can be used~     to treat GVHD. Bortezomib has been used with not too many serious side effects in patients~     with multiple myeloma who will undergo transplant and also for acute graft versus host~     disease.~   "
105808|NCT01672216|"~     Previous studies revealed only a low evidence for the various biofeedback methods and pelvic~     floor exercises for treatment of chronic obstipation. The number of randomized controlled~     trials is low with in part significant systemic deficiencies. However, the results from the~     previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are~     so promising that a further randomized controlled trial appears useful to demonstrate a~     higher degree of evidence. The purpose of this study is to determine whether triple target~     treatment (3T) or EMG-Biofeedback alone are effective in the treatment of chronic~     obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.~   "
105809|NCT01672203|"~     Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased~     morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for~     development of CTEPH. It is not known, whether the location of pulmonary embolism (central~     vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been~     performed to assess the CTEPH incidence in different populations: in patients with central~     vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.~   "
105810|NCT01672190|"~     The purpose of this study is to assess the feasibility of recruiting women with urinary~     incontinence into a randomized controlled trial of a yoga therapy program.~   "
105811|NCT01672177|"~     The main aim of the project is to evaluate a self-care intervention program aimed at~     enhancing the ability of mildly disabled and healthy older persons in Singapore to manage~     their health.~      A secondary aim of the study is to evaluate the effectiveness of training community health~     workers located within Senior Activity Centres in Singapore to support the self-care~     capacity development amongst older persons in the locale.~   "
105812|NCT01672164|"~     The main focus of this study is to develop blood and/or urine tests that will help to detect~     early signs of rejection in people who have had a liver transplant. Researchers will examine~     blood, urine, and tissue samples and try to identify markers for certain conditions such as~     rejection, response to therapy, and scarring of the liver. Additionally, researchers would~     like to identify biomarkers that can detect damage to the native kidneys before blood levels~     of creatinine rises. By studying gene expression, researchers hope to be able to diagnose~     these conditions earlier and improve liver survival.~   "
105815|NCT01672125|"~     Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb~     enables monitoring changes in the lymphedema and the effect of treatment. Circumference~     measurement using a measuring tape is an inexpensive simple method and therefore useful and~     widespread in clinical practice. Circumference measurement performance varies amongst~     therapists and lacks uniformity in the literature. To date, the effect of different limb~     positions on measurement results has not been examined.~      Purpose: The purpose of this study is to describe 1) the effect of position on upper limb~     volume measurement by using circumference measurement and 2) to examine whether the~     difference between positions are similar in the upper limbs of the same woman, and 3)~     between groups of women who are in the intensive phase, in the maintenance phase of~     lymphedema treatment and women without lymphedema~   "
105816|NCT01672112|"~     The efficacy of codeine is dependent on its demethylation to morphine. This extent of~     demethylation has wide inter-individual variability, making codeine's efficacy as a~     analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid~     receptors.~      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.~     Traditionally, craniotomies were not thought to be very painful procedures, hence the use of~     codeine, a moderately potent opioid (when compared to morphine).~      However, in recent years, it has been found that up to 70% of post-craniotomy patients have~     moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies~     have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and~     patients on these stronger opioids generally had lower pain scores and better satisfaction.~      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral~     codeine.~      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain~     relief in post-craniotomy patients.~   "
105817|NCT01672099|"~     In this study, the beneficial effect of a nutrient enriched dairy product will be~     investigated on vitamin K-status. To achive this benefit, the study product contains extra~     vitamin K2. In addition, extra dairy minerals have been added to the study product that may~     support general health.~   "
105818|NCT01672086|"~     The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a~     retrospective, multi-center, single-arm study intended to collect data on the survivorship~     and long-term safety and effectiveness of the device.~   "
105819|NCT01672073|"~     The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the~     arterial line doesn't significantly attenuate the arterial pressure wave form. The principal~     aim of the trial will be:~      • To obtain quantitative data allowing investigation of the pressure wave form obtained in a~     standard arterial line compared to various arterial lines fitted with the Proxima 3.~   "
105820|NCT01672060|"~     Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr.~     David Olds in the United States (US) with the goal of helping vulnerable young first-time~     mothers and their children. The program involves public health nurses (PHNs) visiting~     mothers in their homes, providing intensive supports starting in pregnancy and continuing~     until children reach their second birthday. Studies in the US have shown that NFP~     significantly reduces child maltreatment and child behaviour problems, while also improving~     children's early learning and mother's economic self-sufficiency. Economic studies have also~     shown that the program pays for itself over the long-term. However, NFP has never been~     tested in Canada. Due to major differences in our populations and in our public services, we~     do not know whether NFP will show the same benefits here. We therefore plan to conduct a~     scientific evaluation of NFP's effectiveness in British Columbia (BC), in close~     collaboration with the BC government and BC's Health Authorities. Using~     randomized-controlled trial methods, NFP's effectiveness will be specifically evaluated in~     comparison with existing perinatal services in BC regarding outcomes across three~     fundamental domains: 1) pregnancy and birth; 2) child health and development; and 3)~     maternal health and life course. Findings from this evaluation will be used to improve the~     NFP program — to better meet the needs of vulnerable young mothers and their children in BC.~   "
105821|NCT01672047|"~     The investigators hypothesize that the chronic kidney disease patients who suffer from~     vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery~     calcification and hyperparathyroidism will be improved.~   "
105822|NCT01672034|"~     The purpose with this study is to investigate whether gastric bypass surgery and the~     following weight reduction impact the tone in esophageal sphincters and the esophageal~     function.~      In a previous study our group used high resolution solid-state manometry to investigate the~     pressure in the esophagus and esophageal sphincters in obese patients going through~     laparoscopic bariatric surgery. These studies showed that the barrier pressure between the~     stomach and esophagus is significantly lower in obese compared to lean patients. In this~     study the investigators will examine these patients once more, now after weight reduction to~     see whether the barrier pressure is back to normal compared to lean patients.~   "
105823|NCT01672021|"~     Because MRI can provide increased brain and liver lesion detection as compared with CT, the~     investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion~     detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation~     dose.~   "
105824|NCT01672008|"~     This study is designed to evaluate the safety, tolerability and efficacy profile of NOX-100~     to reduce intradialytic hypotension (IDH) in patients undergoing chronic hemodialysis (HD).~   "
105825|NCT01671995|"~     This study examines whether a nurse monitored management program at the hospital heart~     failure outpatient clinic can improve quality of life in elderly patients with chronic heart~     failure, as compared to standard treatment in primary healthcare.~   "
105826|NCT01671982|"~     To assess the drug concentrations of tenofovir (TDF) in HIV-infected Thai adults with~     moderate renal function impairment when administered at the recommended dose of 300 mg every~     48 hours, and at an alternative dose of 150 mg every 24 hours.~   "
105827|NCT01671969|"~     The purpose of this study is to determine whether a very low calorie diet will stabilize or~     improve diabetic kidney disease.~   "
105828|NCT01671956|"~     This is a randomized, double blind, placebo-controlled, parallel group multi-center study in~     adult patients with active moderate to severe UC . Eligible patients will be randomly~     assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching~     placebo, respectively~   "
105830|NCT01671930|"~     Introduction~      Cardiovascular disease is the leading cause of death in the Western world. The main cause~     for cardiovascular events is the development of atherosclerosis in the coronary arteries. In~     more than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture,~     which results in subsequent formation of an occluding thrombus. Plaques that have a high~     risk of rupture are called vulnerable plaques. Cardiovascular imaging provides a~     complementary diagnostic approach in the assessment of cardiovascular risk in patients.~     However, the lack of biological detection possibilities of current imaging technologies~     limits their predictive value. For instance, multi detector computed tomography (MDCT) is an~     excellent tool to visualize coronary atherosclerosis. However, individual risk assessment is~     still problematic. Which of the diagnosed atherosclerotic plaques will undergo plaque~     rupture and lead to acute vascular events is currently hard to predict. Potentially, serum~     biomarkers could help identify the patient at risk. A wide variety of prognostic markers~     related to atherosclerosis have been identified in the past to predict for cardiovascular~     events. Nevertheless, their predictive value in individual patients is still limited. A~     difficulty in serum biomarker research is the requirement of large patient cohorts to study~     the relation between event rate and serum biomarker levels. The necessity to perform lengthy~     and costly studies, hinders the translation of novel cardiovascular serum biomarkers into~     the clinic. An alternative approach could be to study the correlation between levels of~     serum biomarkers and the presence of atherosclerosis in the coronary arteries.~      Study objectives~      Primary objective of the present analysis is to investigate the predictive value of a~     variety of serum biomarkers to predict atherosclerosis in the coronary tree of patients~     undergoing cardiac MDCT.~      Design and Methods~      Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with~     acute coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency,~     allergy for contrast medium and inability to obtain informed consent. Permission to store~     the serum samples for future analysis of new prognostic markers for cardiovascular events~     will be acquired from the patients. Written information is send to the patient at least 1~     week prior to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum~     duration of 15 years. Once measurements from the samples will be performed, the serum~     samples will be sent by the Biobank coded to the analyzing researchers, which have no access~     to the key file where codes are linked to the specific hospital identity number. This file~     will be stored by an independent researcher at the Cardiology department of the Maastricht~     University Medical Center. The assessment of atherosclerotic burden of the coronary tree~     will be performed by cardiac MDCT specialists blinded to the clinical data and serum~     biomarker outcome. Biomarker levels are correlated to the severity and amount of coronary~     artery disease as assessed by cardiac MDCT.~   "
105831|NCT01671917|"~     The purpose of this study is to determine whether a standardized education and exercise~     program proposed before a total knee replacement for knee osteoarthritis is effective in~     functional recovery after surgery.~   "
105832|NCT01671904|"~     This multi-center, open-label, dose-finding study will evaluate the safety and~     pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with~     bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to~     participants with relapsed/refractory or previously untreated CLL. The study will explore~     two schedules for drug administration, Schedule A (venetoclax introduced before other~     agents) and Schedule B (introduced after other agents). In addition, the study will explore~     two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is~     optional). The study is comprised of two stages for each participant population: a~     dose-finding stage and a safety-expansion stage. The dose-finding stage will explore~     multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.~   "
105833|NCT01671891|"~     Rectal cancer is one of the most common malignant tumors in the world. However, there's also~     no reliable and sensitive method to monitor diseases and evaluate therapy responses till~     now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may~     be a promising method in this field. This study is to investigate the role of circulating~     tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal~     cancer.~   "
105834|NCT01671878|"~     In this study, postprandial glucose and insulin responses of different foods will be~     measured in individuals with varying body weight.~   "
105835|NCT01671865|"~     The purpose of this research study is to identify and study changes in muscle in people with~     facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.~   "
105836|NCT01671852|"~     Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep~     characterized by prolonged partial upper airway obstruction and/or intermittent complete~     obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition~     occurs in 2-5% of children and can occur at any age, but it is most common in children~     between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease,~     growth delay, poor learning and behavioral problems such as inattention and hyperactivity.~     The most common underlying risk factor for the development of OSA is enlargement of tonsils~     and adenoids. Given the potential risk of complications associated with surgery of the~     tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been~     considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent~     Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to~     moderate OSA4. The authors recommended that further randomised controlled studies were~     required to evaluate the efficacy of INCSs in children with OSA. In particular they~     recommended that future studies should employ sleep studies to look for any improvement with~     INCSs, and should include children with more severe OSA, as these are the patients at the~     greatest risk of complications of surgery and would benefit most from a non-surgical~     treatment. The purpose of this study is therefore to explore the efficacy of INCSs in~     children with the full spectrum of OSA severity, including sleep study analysis., and longer~     term follow-up.~   "
105837|NCT01671839|"~     The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System~     for the improvement in the appearance of cellulite.~   "
105838|NCT01671826|"~     Autologous stem cell transplantation remains the gold standard of treatment for newly~     diagnosed patients under the age of 65. Even though it is also regularly performed above the~     age of 65, there are very few data in this patient population. The investigators will~     capture safety and efficacy data in that setting.~   "
105839|NCT01671813|"~     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in~     patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects)~     of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied.~     It is not known if brentuximab vedotin is better or worse than other treatment that might be~     given.~   "
105840|NCT01671800|"~     The objective of this study is to determine if Myobloc significantly decreases~     prosthesis-associated symptomatic sweating in amputees when compared to a saline solution~     placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a~     total enrollment of 32 amputee subjects.~   "
105841|NCT01671787|"~     This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil~     fumarate (TDF).~   "
105842|NCT01671774|"~     The purpose of the trial is to assess the immunological effects and their kinetics, the~     safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses~     of Interleukin-2 in subjects with advanced gastroesophageal cancer.~   "
105843|NCT01671761|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response~     in two age groups: adolescents and young adults.~   "
105844|NCT01671748|"~     Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard~     treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST~     ultrasound system is a noncontact device which delivers low frequency ultrasound through a~     gentle saline mist directed at a patient's wound. This study aims to determine whether the~     use of the MIST device used in combination with standard treatments can improve healing of~     VLUs compared to UK standard practice. This will be assessed by measuring any reduction in~     wound size in the two groups after receiving 8 weeks of either Standard Care once a week or~     MIST combined with Standard Care three times a week.~   "
105845|NCT01671735|"~     This study will collect baseline survey data from a NCP funded VA Diabetes Prevention~     Program (VA DPP) clinical demonstration program at three medical centers on VA DPP~     participants and VA DPP-eligible VA MOVE! participants to identify baseline participant~     demographic characteristics; attitudes and beliefs about diet, exercise and weight loss, and~     psychosocial constructs such as social support; and self-regulation skills that predict~     6-month weight loss and program attendance. The data collected will contribute to our~     knowledge of pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight~     loss, to our understanding of how different programs may impact weight loss, and to~     evidence-based targeting in future clinical implementation projects. It will also provide~     baseline quality of life data for use in a future cost-effectiveness analysis.~   "
105846|NCT01671722|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
105847|NCT01671709|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
105848|NCT01671696|"~     The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and~     progressive extracellular matrix remodeling will precede echocardiographic indices of~     systolic and diastolic function among childhood cancer survivors treated with anthracyclines~     thus allowing evaluation of new therapies to prevent and manage heart failure in these~     patients.~   "
105849|NCT01671683|"~     The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant~     chemotherapy with capecitabine during the resting periods in patients with locally advanced~     rectal cancer.~   "
105850|NCT01671670|"~     Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia~      Design:~        -  A single blind randomized controlled trial~        -  200 participants will be included~        -  Two arms: acupuncture and sham acupuncture group~   "
105851|NCT01671657|"~     The purpose of this clinical investigation is to gather data to evaluate the impact of using~     Eeva with traditional morphology grading on implantation rates.~   "
105852|NCT01671644|"~     The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva~     with traditional morphology grading on clinical pregnancy rates.~   "
105853|NCT01671631|"~     The assessment of non-culprit stenoses is an important issue in ACS. Adenosine~     administration is currently required for functional evaluation of stenosis severity using~     the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary~     stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.~      Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free~     pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow~     reserve (FFR) in ACS patients.~   "
105854|NCT01671618|"~     The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound~     (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending~     aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the~     measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal~     disease.~   "
105855|NCT01671605|"~     There is currently little understanding of macrophage cholesterol homeostasis and foam cell~     formation across the spectrum of CKD. We hypothesize that an inverse relationship exist~     between the severity of CKD and processes underlying foam cell formation, and that the~     relationship becomes independent of serum lipoprotein levels as renal function declines. We~     propose to systematically examine scavenger receptors and cholesterol uptake as well as~     cholesterol transporters and efflux mechanisms in individuals with normal renal function,~     patients with moderate CKD and those with ESRD-HD. We further propose to determine if~     processed contributing to foam cell formation are related to the plasma lipid profile and if~     the relationship is modified by co-morbidities, such as diabetes, obesity, systemic~     inflammation which are common in this population and directly influence vascular integrity.~     These data will be critically important to understand when the abnormality starts and will~     provide crucial information.~   "
105856|NCT01671592|"~     This study will evaluate the safety and feasibility MRI tracking of a vaccine produced from~     a persons cancer cells injected intradermally once a day for 3 consecutive days. One of the~     daily doses will contain a chemical that can be detected by an MRI. That will be either the~     1st or 3rd day of the 3 day course. On that day MRI scans will be performed 6 and 24 hours~     after the injection on that day. Patients may be able to receive booster doses every 1-2~     months~   "
105857|NCT01671579|"~     To establish the accuracy of bowel ultrasound in the follow-up of known (previously~     diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance~     imaging technology used to obtain detailed images of the small bowel) as the reference~     standard.~   "
105858|NCT01671566|"~     Adults with congenital heart disease have various degrees of impaired exercise capacity~     compared to healthy controls. Impaired exercise capacity makes everyday activities more~     difficult and demanding. There are few studies on effect of exercise training in adults with~     congenital heart disease. The hypothesis of this study is that structured home based~     exercise training will improve exercise capacity and health status in the studied~     population.~   "
105891|NCT01671124|"~     Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang~     supplementation on mood, this study is a clinical study of Soline® (product mixed with~     Salvia divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of~     attenuating the occurrence of depression. The study will enroll 100 patients who meet the~     inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80~     patients (40 patients in each treatment group).~   "
105859|NCT01671553|"~     Background The home is the primary source of SHS exposure. The scientific evidence shows~     that there is no risk-free level of exposure to SHS that stop smoking is the sole way to~     completely eliminate the risk of SHS exposure. Although research studies indicated that~     smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS~     exposure, governments lack the authority to restrict smoking in homes. Therefore, parental~     cessation is a more effective means to reduce the SHS exposure.~      Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect~     of different smoking cessation approaches through the Smoke-free Teen Contest. The specific~     objectives of the study are to test the effectiveness of different smoking cessation~     approaches on quit rate and change in smoking behaviours among smokers who are referred by~     Hong Kong Council on Smoking and Health (COSH).~      Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined~     the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)~     the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months~     and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and~     (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6~     months.~      Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),~     were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized~     by COSH. Those smokers will be randomized into two groups (Intervention group and Control~     group) using the clustered randomization method by school. After the clustered~     randomization, the oral consent of eligible subjects were obtained to the study through~     telephone interview. Intervention group will receive 1,2,3, 8-week and 6-month telephone~     follow-up after baseline, while control group will only receive 6-month telephone follow-up~     after baseline. Those participants who reported to have stopped smoking will be invited for~     biochemical validation of smoking status at 6-month follow-up.~      Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will~     lead to significant increases in rates of smoking cessation in the intervention groups than~     the control group.~   "
105860|NCT01671540|"~     In this study the invetigators seek an answer on the following hypothesis:~        -  What are the long term effects of an IPV treatment evaluated with classical outcome~          parameters? (FEV1, Raw)~        -  Is the possible effect noticeable on the novel technique and is this comparable with~          the classical outcome parameters?~   "
105861|NCT01671527|"~     The purpose of this research study is to determine the physical brain changes in people with~     cervical dystonia after deep brain stimulation (DBS) surgery and as compared to healthy~     controls. We will do this by measuring your body's response to transcranial magnetic~     stimulation (TMS) before and/or after DBS surgery.~      TMS is a non-invasive procedure during which you sit in a chair that looks like one you~     would find at the dentist's office. A nerve stimulator is placed on the wrist of the right~     hand to stimulate the median nerve; the intensity of the nerve stimulator is gradually~     increased until the right thumb begins to twitch. A magnetic coil is placed on the scalp on~     one side of the head, overlying the brain's motor cortex, to stimulate the brain's output to~     the muscles in the opposite hand.~      If you are a control subject, and therefore will not/have not have DBS surgery, we will~     measure the body's response to TMS for comparison purposes. We expect that the electrical~     differences in the brain may be related to the physical benefits some patients with primary~     cervical dystonia receive from DBS surgery.~   "
105862|NCT01671514|"~     The major goal of this study is to characterize the ability of dark chocolate enriched in~     epicatechin (a component of dark chocolate) to improve the structural and functional~     features of mitochondria in two groups~        1. Patients with heart failure (HF) and type 2 diabetes (DM2) and~        2. Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed~          by VO2 max)~      We propose that a 3 month treatment with dark chocolate will lead to a significant~     improvement in exercise capacity which will be secondary to the improvement in skeletal~     muscle structure from epicatechin.~   "
105863|NCT01671501|"~     This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol~     screen; and examines innovative behavioral interventions, and their cost effectiveness, for~     hazardous drinking within a large HIV primary care clinic. We will compare Motivational~     Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the~     interventions on hazardous drinking, enrollment in substance use treatment programs, and HIV~     outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given~     the well-known adverse effects of hazardous drinking on HIV care and outcomes, the proposed~     study has the potential to make a significant impact in the care of HIV patients.~   "
105864|NCT01671488|"~     The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when~     combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is~     an investigational agent that is not approved by the FDA to treat anal cancer or any other~     cancer.~   "
105865|NCT01671475|"~     The proposed study aims to test the impact of microEEG on clinical management (diagnosis and~     treatment) of emergency department patients with Altered Mental Status (AMS). The study will~     utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients~     will be randomized to routine care plus microEEG (experimental arm) or routine care alone~     (control arm). The investigators hypothesize that incorporating microEEG in the work up of~     patients with AMS will impact the clinical management of these patients.~   "
105866|NCT01671462|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human~     Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV~     diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or~     residual) and a BD cervical brush in BD transport medium to reference histology results from~     biopsy.~   "
105867|NCT01671449|"~     A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly)~     versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric~     cancer~   "
105879|NCT01671293|"~     The purpose of this study is to determine whether a multi-component remote care model~     (telephone-based) is effective to achieve the modification of unhealthy eating practices and~     increase physical activity in adults who have prediabetes and over-weight/obesity. The~     effectiveness of the remote care model will be determined with respect to the mentioned~     practices as well as anthropometric parameters (Waist circumference and Weight) and clinical~     parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to~     changes in these habits. The counseling intervention is the core of the multi-component~     tele-care model, which also includes counseling-through text messages, supply of Educational~     material and self-monitoring equipment (pedometers and measuring tape for patients to check~     their waist circumference).~   "
105880|NCT01671280|"~     To collect the efficacy and safety information of Azithromycin IV related to their~     appropriate use in daily practice~   "
105892|NCT01671111|"~     The purpose of this extension study is to evaluate SSP-004184AQ in patients with~     transfusional iron overload and to provide data on long term safety and efficacy.~      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to~     patients with transfusional iron overload~   "
105868|NCT01671436|"~     Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition.~     However, currently available treatment options have limited efficacy. The aim of this pilot~     study is to determine whether patients suffering from MDD who have not responded to at least~     one antidepressant trial may actively engage in a novel group therapy, Central Meditation~     and Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT~     techniques may have benefit for major depression. The purpose of this trial is to assess the~     feasibility of a group form of CMIT for the treatment of major depression. The trial will~     also seek to identify neurophysiological and cardiovascular predictors of treatment~     response.~      In this study, 10 subjects with major depressive disorder will receive antidepressant~     treatment augmentation with group meditation and mental imagery therapy for a total of 12~     weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic~     stretches. The subjects will be limited to those who remain depressed despite at least one~     trial of antidepressant medication. Changes in brain activity and heart rate variability~     will be measured at three time points utilizing electroencephalography (EEG) and pulse~     monitors. Depression symptoms will be measured at several time points using questionnaires~     and objective measures. Participation will require a total of 15 visits for weekly therapy~     and the measurements. Two-month follow-up questionnaires will be mailed to the subjects~     after study end to assess durability of any improvements in depressive symptoms.~   "
105869|NCT01671423|"~     Cellulitis is the medical term for an infection of the skin, with symptoms including~     redness, swelling, warmth, and pain. This group of symptoms is called inflammation, and is~     caused by the body's immune system responding to the infection. Standard care for cellulitis~     is using antibiotics to destroy the infection, but the inflammation can persist and cause a~     great deal of pain. The hypothesis of this study is that adding a single dose of an oral~     steroid (prednisone), which tempers the immune response, will reduce inflammation, reduce~     pain, and speed recovery. This hypothesis will be examined by recruiting a group of patients~     with cellulitis, and randomizing them to two sub-groups: one group will receive a dose of~     prednisone, while the other group will receive a placebo. Neither group will know what they~     received unless there is a problem. These subjects will be followed up at the 48 hour mark~     and the 7 day mark, and will have their results compared.~   "
105870|NCT01671410|"~     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after~     utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS.~     This trial will investigate the safety and tolerability of sublingual buprenorphine in~     infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in~     those who are breastfeeding.~   "
105871|NCT01671397|"~     The prevalence of obesity has steadily increased in the United States. This can lead to the~     worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease~     and osteoarthritis. The medical management of obesity involves dietary counseling and~     education, behavioral counseling with goal setting, and exercise. Patients with short sleep~     periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even~     after controlling for other factors. We hypothesize that the addition of focused counseling~     on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help~     women lose weight.~   "
105872|NCT01671384|"~     Spinal muscular atrophy (SMA), an autosomal recessive disorder, is characterized by muscle~     weakness due to degeneration of anterior horn cells in the spinal cord and brain stem~     nuclei. It has a variable incidence of 1 in 6700 to 1 in 25000 live births and prevalence of~     0.12 to 25 per 10,000 populations in different geographic areas and genetic constitution. A~     homozygous deletion/mutation involving exon 7 in SMN1 (survival motor neuron 1) is present~     in around 95% of the cases, resulting in the biochemical deficiency of the SMN protein. A~     genomic duplication at the same locus produces nearly identical SMN2 (survival motor neuron~     2) that differs from SMN1 by a nucleotide substitution that promotes exon 7 exclusion thus~     giving rise to only a fraction of the full length protein. Phenotypic variation in SMA~     correlates with the number of SMN2 gene copies and the level of SMN protein in cells.~      Several hypotheses including defective inhibition of apoptosis, glutamate excitotoxicity and~     lack of a neurotrophic factor(s) in nerve or muscle have been speculated in the pathogenesis~     of SMA.~      Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, directly increases SMN~     expression in SMA patient-derived cell lines in vitro. Till date 3 open label trials and 1~     placebo controlled RCT of VPA in human subjects have been published, all indicating a~     possible benefit in strength and/or motor function. Till date there is no effective therapy~     for SMA. Therapy is mainly supportive and palliative which can prolong lifespan and prevent~     complications to some extent without actually curing the disease.~      Children with SMA may have a reduced capacity to synthesis carnitine consequent to~     significantly diminished skeletal muscle mass. VPA independently inhibits carnitine~     transport and its metabolites deplete carnitine levels by binding to them. So along with~     valproate these patients should be supplemented with carnitine.~      With this background the investigators have planned a double blind randomized placebo~     controlled trial of Valproate and levocarnitine in 60 children (30 each in intervention and~     control arm) with Spinal Muscular Atrophy aged 2-15 years over a 2 year period with one~     baseline and four follow up visits. The study will be conducted in the Department of~     Pediatrics, AIIMS at the Myopathy clinic.~   "
105873|NCT01671371|"~     The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists~     physicians in the evaluation and management of patients with syncope.~   "
105874|NCT01671358|"~     This study is to determine if medication cabinets located outside of isolation rooms in~     hospitals and their contents, particularly medications and the delivery folders are at a~     higher risk of having harmful bacteria on them.~   "
105875|NCT01671345|"~     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the~     prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in~     the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a~     number of complications including cardiovascular disease, blindness, amputation, and end~     stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as~     diet and exercise) is important to achieve diabetes care goals. Adherence to recommended~     care is related at least in part to effective communication in medical encounters. This~     project is designed to test a video intervention to improve patients' communication~     behaviors. Doctors will also receive a communication skills training program. The project~     will assess the impact of the training programs on communication and outcomes. The study is~     designed to help make patient care more patient-centered, which is one of the six aims for~     improvement in the IOM Report, Crossing the Quality Chasm and is a goal of VA transformation~     efforts.~   "
105876|NCT01671332|"~     The overall purpose of the study is to determine whether or not the inclusion of suramin to~     standard treatment with docetaxel improves progression-free survival for patients with~     advanced non-small cell lung cancer in the second and third line settings.~   "
105881|NCT01671267|"~     The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,~     allegedly due to the substantial load of these body regions during work. Work disability is~     a common consequence of these pains. Lowering the physical exposure through ergonomic~     intervention may be a strategy to reduce the workload. An alternative strategy could be to~     increase the physical capacity through strength training of the shoulder-, arm- and~     hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load~     reduction (ergonomic intervention) versus training of physical capacity (strength training)~     on pain and work disability in slaughterhouse workers.~      The main hypothesis is that strength training intervention for 10 weeks compared with~     ergonomic intervention results in reduced pain of the shoulder, arm and hand.~   "
105882|NCT01671254|"~     The purpose of this 8-week intervention trial is to investigate the effect of a dietary~     supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in~     healthy hyperlipidemic subjects~   "
105883|NCT01671241|"~     Hypothermia after delivery is a world-wide problem associated with morbidity and mortality.~     The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is~     unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin~     wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very~     preterm babies and represents the standard of care recommended by the International~     Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce~     heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the~     proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped~     group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The~     combination of body and head protection with a polyethylene wrap needs to be evaluated~     further. The investigators conducted a prospective, randomized, controlled trial in very~     preterm infants to evaluate whether a polyethylene total body wrapping (body plus head)~     prevents heat loss after delivery better than polyethylene occlusive wrapping.~   "
105884|NCT01671228|"~     The purpose of this research is to develop a patient decision aid in paper and web formats~     to help patients with chronic kidney disease make informed dialysis treatment decisions.~   "
105885|NCT01671215|"~     fibroids are common among women in fertile age. the relation between fibroids and~     infertility is controversial. our goal is to claculate a ratio between uterine cavity -~     endometrium & myometrium in normal uterine s and study the interference of the cavity in~     uterine s with fibroids.~   "
105886|NCT01671189|"~     Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation~     tool to automate appointment confirmation and rescheduling. Working in parallel with the San~     Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will~     automate reminders that request text responses from patients to either confirm or request to~     reschedule their upcoming appointments. While simple in concept, this tool aims to free up~     scarce clinical resources which are currently allocated to daily patient phone call~     reminders. With funding from a Bay Area foundation, the investigators will develop and pilot~     this open-source software tool in a 12-month randomized-controlled trial, slated to begin in~     October 2012. The endpoints of the study will aim to demonstrate improvements in both~     appointment adherence and glycemic control.~   "
105887|NCT01671176|"~     To assess implant stability, implant loss, adverse skin reactions, and Quality of Life~     Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to~     determine the feasibility of fitting the sound processor 3 weeks after surgical~     implantation, and to investigate if the type of skin reactions following implantation could~     be related to the demographic data of subjects and the type of surgical technique used~   "
105888|NCT01671163|"~     The purpose of this research study is to evaluate placing the radiation therapy markers~     (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an~     Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an~     ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation~     therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.~   "
105889|NCT01671150|"~     Depressive disorders occur at a high rate in patients with inflammatory disorders, with a~     point prevalence of 15-29%, which is two to three times greater than that observed in the~     general population. Substantial evidence has shown that inflammation and increases in~     proinflammatory cytokine activity play a critical role in the onset and perpetuation of~     depression and depressive symptoms (e.g. insomnia, fatigue) in those who are co-morbid for~     inflammatory disorders. Consistent with this, experimental work has shown that an~     inflammatory challenge can increase depressed mood in an otherwise healthy sample. Based on~     these findings, there has been a growing interest in whether inflammatory processes can~     contribute to depression in a causal manner and how these effects might occur.~      Given the observation that inflammatory processes trigger social withdrawal, coupled with~     evidence that feelings of 'social disconnection' play a critical role in the onset and~     perpetuation of (non-inflammatory forms of) depression, it is surprising that the social~     psychological consequences of inflammation and their contribution to depression have not~     been more fully explored. Here, we suggest that inflammation may increase feelings of social~     disconnection and that these social psychological changes may be an important contributor to~     inflammation-associated depression. Indeed, preliminary data demonstrated that an~     experimentally-induced inflammatory challenge (endotoxin) led to increases in self-reported~     feelings of social disconnection (e.g., I feel disconnected from others) in addition to~     increases in depressed mood. Aside from these findings, however, there are no studies that~     have explored the effect of inflammatory processes on social experience in humans. The~     over-arching objective of this proposal is to explore the experiential and neural correlates~     of inflammatory-induced changes in social experience (e.g., feelings of social~     disconnection), which may provide a critical missing link in understanding the relationship~     between inflammation and depression.~      Participants (n=100) will be randomly assigned to receive either endotoxin or placebo and~     will then be monitored for the next six hours. Blood draws to assess cytokine levels as well~     as self-reported feelings of social disconnection and depressed mood will be collected~     hourly. In addition, at the time of peak cytokine response, participants will complete a~     neuroimaging session to examine the effect of inflammatory challenge on neural sensitivity~     to social rejection and social acceptance. It is hypothesized that endotoxin will increase~     feelings of social disconnection over time, and that the underlying neural sensitivities~     that give rise to these feelings (e.g., increased neural sensitivity to social rejection;~     decreased neural sensitivity to social acceptance) will contribute to inflammatory-induced~     depressed mood.~   "
105890|NCT01671137|"~     The present study has several aims:~        1. Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS~          in a high risk group of children enrolled after an acute gastroenteritis (the study has~          been powered to this aim).~        2. Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal~          microbiota after an acute gastroenteritis.~        3. Define the intestinal microbiota of children following an acute gastroenteritis and~          identify, if possible, a modification of the microbiota that can predict the emergence~          of Irritable Bowel Syndrome.~   "
105949|NCT01670370|"~     The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and~     Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with~     aggressive B cell lymphoma.~   "
105950|NCT01670357|"~     This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared~     with placebo in dry eye syndrome.~   "
105893|NCT01671098|"~     Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal~     interface that represents a collection of airfoils creating an aerodynamic structure. The~     airflow during respiration generates positive and negative pressures that power the gas~     exchange between the sinuses and the nose. Major surgical alteration of the interface~     reduces the rate and velocity of the exchange. Minimally invasive procedures aimed at~     preserving the natural anatomy, topography and aerodynamic configuration of the interface~     will have negligible effects on sinonasal gas exchange.~   "
105894|NCT01671085|"~     This is a study in healthy participants with high levels of bad cholesterol who are~     already taking a popular type of cholesterol-lowering medication called statins. Following~     multiple doses of LY3015014, investigators will study the safety and tolerability of the~     drug, how the body handles the drug, and the drug's effect on the body. Participants will~     remain in the study for about 3 months, not including screening. Screening is required~     within 28 days before the study starts.~   "
105895|NCT01671072|"~     The purpose of this study is to determine whether TissueGene-C, an allogeneic human~     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in~     patients with degenerative arthritis~   "
105896|NCT01671059|"~     This non-interventional study evaluated the use and efficacy of tocilizumab~     (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible~     participants initiated on tocilizumab treatment according to the approved label were~     followed for 6 months.~   "
105897|NCT01671046|"~     This multi-center, prospective observational study will evaluate the correlation of liver~     biopsy and transient elastography in liver fibrosis assessment in patients with chronic~     hepatitis C. Data will be collected for 96 weeks.~   "
105898|NCT01671033|"~     From the scarce literature it showed that computer/internet-aided cognitive behavior therapy~     (CBT) was superior to waitlist and placebo assignment across outcome measures, and the~     effects of computer/internet-aided CBT were equal to therapist-delivered treatment across~     anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based~     relaxation with biofeedback treatment for panic disorder.~   "
105899|NCT01671020|"~     Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan~     and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of~     Kanarb® tablet (fimasartan) in healthy subjects~   "
105900|NCT01671007|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into two~     protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area)~     countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in~     both protocols is estimated to be 48,000 patients, and all these patients will be included~     in the data analysis for study 1160.129.~   "
105901|NCT01670994|"~     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801~     in patients who have relapsed or refractory multiple myeloma.~   "
105902|NCT01670981|"~     This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T~     compared to placebo (vehicle control) when administered via transendocardial catheter-based~     injections to patients with end stage heart failure due to IDCM, who have no reasonable~     revascularization options (either surgical or percutaneous interventional) likely to provide~     clinical benefit.~   "
105903|NCT01670968|"~     Primary Objective:~      To examine changes in expression of genes [particularly ABCA1 and SREBP2] involved in~     reverse cholesterol transport (RCT) in monocytes from HIV-infected subjects starting~     antiretroviral therapy and the different effect of NNRTI and PI based regimens~      Secondary Objective:~      To examine changes in monocyte intracellular cholesterol content in HIV-infected subjects~     starting antiretroviral therapy and the different effect of NNRTI and PI based regimens~   "
105904|NCT01670955|"~     PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT~     OF ANAEMIA IN GYNAECOLOGICAL PATIENTS~   "
105905|NCT01670942|"~     The purpose of this research is to see if people who have had a collapsed lung that has been~     re-expanded can be safely taken to an elevation that a person might experience while in a~     commercial airplane without having their lung partially collapse again, or have any symptoms~     such as feeling short of breath or having oxygen levels in the blood decrease while at the~     simulated altitude.~      The investigators hypothesize that subjects who have had a collapsed lung that has been~     re-expanded will not have any adverse symptoms or signs while subjected to a simulated~     altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).~   "
105906|NCT01670929|"~     In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice~     daily), started soon as possible at luteal phase and after a positive pregnancy test and~     continued to 28 weeks of gestation, compared to placebo, ).~   "
105907|NCT01670916|"~     Probiotics is given routinely to infants admitted to the department of neonatology during~     the first 3 days of life with gestational age less than 30 weeks since March 2010. The~     incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from~     clinical records. It is hypothesised that the incidence of NEC will decrease. Infants~     admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec~     2007 to 30 Nov 2009 will be compared.~   "
105908|NCT01670903|"~     Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the~     aortic wall. The natural history of AAA is gradual expansion and if left untreated may~     result in rupture and death. The mechanism of the development of this disease is unknown~     however it appears to be multifactorial and possibly related to degradation processes within~     the arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may~     have an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting~     degeneration of the vessel wall.~      Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive~     patients, and are associated with a lower rate of aortic expansion compared to other~     antihypertensive drugs.~   "
105951|NCT01670344|"~     This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative~     positioning system in the clinical setting of orthopedic surgery.~      Aim of the study is the validation and comparison of the innovative medical device with the~     current standard method.~   "
105909|NCT01670890|"~     Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant~     gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ.~     Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment~     procedure has not been established yet.~      The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety~     of TMZ and CDDP in patients with recurrent malignant gliomas~   "
105910|NCT01670877|"~     This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how~     HER2 mutated cancer responds to treatment with neratinib.~   "
105911|NCT01670864|"~     Background According to the report of Census & Statistics Department, there are still~     659,300 daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year. The~     Quit and Win programme provided another opportunity to reach large group of smokers, and it~     aims to widespread quit attempts among smokers via incentives in order to boost up the~     number of quitters. Although such competitions appear to reach large cohorts of smokers,~     there is still insufficient evidence of its effectiveness in helping smokers to achieve~     complete cessation.~      Aim This project aims to promote and evaluate community-based smoking cessation services~     through the Quit to Win Contest organised in the 18 districts of Hong Kong. The specific~     objectives of the study are (1) to build capacity in the community on smoking cessation~     through a training programme; (2) to empower the participated NGOs (a) to raise the~     awareness of smoking cessation in the community level; (b) to reach as many smokers as~     possible; (c) to arouse the interest of smokers to quit, through organizing the Quit to Win~     Contest; (3) to test the effectiveness of community-based on-site face-to-face counselling~     and Short Message Service (SMS) message vs. self-help booklet to assist current smokers to~     quit smoking; and (4) to build-up a community-based participatory research (CBPR) model in~     smoking cessation intervention at a district level in Hong Kong.~      Methods A community-based participatory (CBP) approach, which is an effective way to engage~     public health researchers and community members (NGOs, other major stakeholders, and~     participants), will be used. Two domains of outcome will be assessed: (1) Effectiveness of~     smoking cessation interventions, (2) process evaluation of the recruitment activities~     including number of eligible participants and amount of publicity.~      Procedure At the recruitment sites, after screening for eligibility of participants for the~     Quit to Win Contest, smoking counselor will measure eligible participant's level of carbon~     monoxide (CO) on expired air, and provide the self-help smoking cessation materials~     developed by the Hong Kong Council on Smoking and Health (COSH). Then the counselor will~     explain and invite the participants to join the cluster randomized controlled trial on~     smoking cessation intervention. Participants will be allocated to one of the groups of the~     smoking cessation intervention. 3- and 6-month follow-ups will be conducted~      Hypothesis We hypothesize that the on-site brief smoking cessation advice will lead to~     significant increases in rates of smoking cessation in the intervention group than the~     control group (with the self-help materials only). Another hypothesis to be tested is that~     the intervention of sending SMS messages of smoking cessation advice is effective to~     increase the quit rate comparing to the control group.~   "
105912|NCT01670851|"~     This is a prospective, multicenter, single arm, observational pilot study to assess the~     clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction~     following eLAPE and simultaneous stoma reinforcement.~   "
105913|NCT01670838|"~     This is a prospective cohort study investigating cardiac function and cardiac biomarkers in~     patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to~     document the incidence of myocardial dysfunction,to find the predictive factors of~     myocardial dysfunction, describe heart rate variability and to assess the impact of all~     cardiac problems on morbidity and mortality.~   "
105914|NCT01670825|"~     The aim of this study is to determine whether pulsed radiofrequency or steroids are better~     for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the~     occipital nerve who respond to occipital nerve blocks (hereafter included under the broad~     category ON) will be randomized in a 1:1 ratio to receive either corticosteroid and local~     anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38)~     for occipital neuralgia. Both patients and the treating & evaluating physicians will be~     blinded. The first follow-up visit will be at 6 weeks. Patients who obtain significant pain~     relief will remain in the study. Those patients who fail to obtain any benefit will exit the~     study and be allowed to crossover to the other treatments or receive alternative care. The~     second follow-up will be at 3 months and the final follow-up will be at 6-months~     post-procedure.~   "
105915|NCT01670812|"~     The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP),~     high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic~     leukemia.~   "
105916|NCT01670799|"~     The purpose of this study is to evaluate the anti-cancer effect of a pain medication called~     ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after~     surgery for ovarian, fallopian tube or primary peritoneal cancer.~   "
105917|NCT01670786|"~     Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural~     effusion, with minimal adverse events, especially reducing dose.~   "
105918|NCT01670773|"~     This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy~     humans.~   "
105919|NCT01670760|"~     The core temperature of the body normally decreases in response to anesthesia. Deep tissue~     temperature can be used to estimate of body core temperature. Deep tissue temperature of the~     forehead will be measured using a new technology known as zero-heat-flux thermometry. The~     usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal~     temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously~     during surgery and compared for agreement. The hypothesis of this trial is that deep tissue~     temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal~     temperatures during surgery.~   "
105920|NCT01670747|"~     In this study gas-exchange and respiratory mechanics variations to PEEP change will be~     correlated to CT lung morphological modifications assessed at different airway pressures (5,~     15, 30 and 45 cmH2O).~   "
105921|NCT01670734|"~     Primary Objective:~      Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of~     alirocumab SAR236553 (REGN727).~      Secondary Objectives:~        -  Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with~          mild and moderate hepatic impairment and in matched subjects with normal hepatic~          function.~        -  Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with~          hepatic impairment and in matched subjects with normal hepatic function.~   "
105922|NCT01670721|"~     Primary Objective:~      To evaluate the safety of aflibercept in participants with mCRC treated with~     irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based~     regimen (participants similar to those evaluated in the VELOUR trial [EFC10262,~     NCT00561470]) according to side effects prevention and management guidelines.~      Secondary Objective:~      To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant~     population.~   "
105952|NCT01670331|"~     Is it feasible to perform a randomized controlled trial to assess whether or not~     psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial~     to the investigators patients?~   "
139170|NCT01233232|"~     The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients~     with Chronic Obstructive Pulmonary Disease~   "
105923|NCT01670708|"~     The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement~     Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control~     trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program~     provides strict oversight of probationers through a HOPE Court judge and intensive probation~     supervision, including random drug testing, coupled with swift and certain sanctions in~     response to positive results on random drug tests and other violations of conditions of~     supervision. The HOPE DFE Evaluation is being conducted among probation populations in four~     sites and will identify the effectiveness of swift and certain sanctions on targeted~     outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and~     secondary (revocation rates, jail days served, prison days sentenced).~   "
105924|NCT01670695|"~     This is an cohort study to investigate the disease course and treatment response of patients~     with IgG4-related disease.~   "
105925|NCT01670682|"~     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous~     fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh~     are both developed in China for vaginal apex fixation, the former is native tissue repairs,~     and the latter is augmentation with mesh.~      This study is designed to determine the effectiveness and safety of ischia spinous fascia~     fixation procedure compared with modified total pelvic floor reconstructive surgery with~     mesh for the treatment of pelvic organ prolapse stage III.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
105926|NCT01670669|"~     The purpose of this study is characterize the efficacy, safety, tolerability, and~     steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a~     solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal~     retention (FFR) for 8 weeks.~      Hypothesis:~      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the~     adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the~     adult profile.~   "
105927|NCT01670656|"~     The study investigates four vaginal ring groups with respect to relief of primary~     dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant~     treatment efficacy in relief of primary dysmenorrhea.~   "
105928|NCT01670643|"~     The most common goal for patients with vision loss who present for vision rehabilitation is~     to be able to read. The video magnifier (a device which combines a video camera and a screen~     to view the print being magnified) is the device which most often allows low-vision~     individuals to read successfully for extended periods of time. Previous studies on the~     outcomes of vision rehabilitation have not identified which components of the vision~     rehabilitation are effective. The hypothesis of this project is that providing a video~     camera magnifier, with basic training in operating the device, will allow patients to~     enhance both objective reading ability and subjective report of reading competence.~   "
105929|NCT01670630|"~     The purpose of this study is to estimate if a novel sheathed speculum provides improved~     visualization of the cervix compared to a standard (non sheathed) speculum, and to~     estimate if the sheathed speculum causes less discomfort during the examination.~   "
105930|NCT01670617|"~     The purpose of this study is to evaluate the long-term relief of pain and return to function~     for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed~     product and has been used in more than 7,500 patients over the last 7 years.~   "
105931|NCT01670604|"~     This study compares the effect of infusion of two types of modern hydroxyethyl starch on the~     renal function and acid-base in patients undergoing urologic surgery.~   "
105932|NCT01670591|"~     Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the~     universal prevention level, developed by Swedish researchers for the school years 4 -9. By~     defining and teaching school rules to all teachers and students, and by consistently~     acknowledging students when meeting behavioural expectations, the program aims to reduce~     problem behaviours in school areas and to improve the classroom learning climate. Against~     this background, the purpose of this study is to examine whether PS is more effective than~     schools' ordinary practices in meeting these goals.~   "
105933|NCT01670578|"~     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)~     to treat knee degenerative articular cartilage pathology could determine pain relief and~     recovery of knee function with overall clinical outcome comparable or even better than~     viscosupplementation, which is a common injective approach applied in this kind of~     pathology. To this purpose the investigators designed a double blind randomized controlled~     trial comparing PRP vs viscosupplementation.~      A power analysis has been performed for the primary endpoint of IKDC (International Knee~     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP.~     From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of~     0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points~     corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for~     each group. Considering a possible drop out of 15%, 96 patients per group are required for~     total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility~     criteria' section). Patients are then assigned to two different treatment groups, according~     to a randomization list. The first group of treatment consists of three weekly~     intra-articular injections of autologous PRP obtained with the following procedure: a 150-ml~     autologous venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6~     minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate~     platelets) to produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of~     5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for~     a quality test, 3 units are stored at -30° C.~      The second treatment group consists of patients receiving three weekly injections of~     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500~     kDa).~      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain~     autologous PRP which will be used only in half of them, according to the aforementioned~     randomization list. One week after the PRP production, the injective treatment starts, with~     3 weekly injections of PRP or HA. At the moment of the injection the syringe is properly~     covered to prevent the patient from discovering the substance he was receiving. After the~     injection, patients are sent home with instructions to limit the use of the leg for at least~     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,~     the use of non-steroidal medication is forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
105934|NCT01670565|"~     This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled,~     proof-of-concept pilot study. All participants will first be treated with mycophenolate~     mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period,~     half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat~     early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease~     activity measured by an improvement in skin thickening and stability of pulmonary function~     test measurements when compared to patients treated with placebo/MMF.~   "
105935|NCT01670552|"~     The purpose of this study is to evaluate the safety of an association with one~     anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and~     one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.~   "
105936|NCT01670539|"~     The purpose of this study is to learn more about using a home machine Telemonitor to find~     problems people with lung cancer may have after being discharged from the hospital and help~     them manage problems by contacting their healthcare provider.The study hypothesis is that~     patients with lung CA using short-term (14 days)home telemonitors, educated/coached by~     nurses on telemonitor data risks/implications for the first two weeks after hospital~     discharge, will be able to self-report their signs/ symptoms to the clinician resulting in~     decreased use of costly health care resources over 60 days.~   "
105953|NCT01670318|"~     Randomized trials have demonstrated an excellent safety and efficacy profile for the~     chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES)~     uses the identical antiproliferative agent and polymer but with a novel platinum chromium~     scaffold designed for enhanced deliverability, vessel conformability, side-branch access,~     radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES~     for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation~     lesion, left main trunk disease, and small vessel diseases is still unknown.~   "
105937|NCT01670526|"~     Difficulties with intellectual functioning, particularly memory functions, are common and~     source of long-term disability after Traumatic Brain Injury (TBI). However, there is very~     little information about pharmacologic (i.e., medication) treatments targeting these~     deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical~     system that manages memory, in TBI. These findings provide the rationale for the use of~     cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the~     prevalence of TBI among Veterans of recent military conflicts increases, becoming a~     signature injury of the Iraq and Afghanistan conflicts, it is of utmost importance to the~     Veterans Health Administration to collect scientific data on the efficacy of pharmacological~     treatments for intellectual difficulties in TBI patients. This study will evaluate the~     effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI~     and posttraumatic memory problems. Results will provide much needed data that will help~     treat Veterans with TBI.~   "
105938|NCT01670513|"~     Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area~     affected will be enrolled in the study.~   "
105939|NCT01670500|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug, which is cisplatin in this trial, to learn how~     well it works in treating a specific cancer. Investigational means that cisplatin is still~     being studied for use in this setting and that research doctors are trying to find out more~     about it-in this case, how effective cisplatin is for treating breast cancer in BRCA~     mutation carriers. It also means that the FDA has not yet approved cisplatin for your type~     of cancer. Cisplatin has been approved by the FDA for treatment of other cancers.~      The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown~     to be active in the treatment of women with breast cancer and a BRCA mutation. In this~     study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and~     cyclophosphamide (AC) that you might receive if you did not participate in this study.~   "
105940|NCT01670487|"~     To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in~     decreasing the pain of intravenous cannulation.~      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)~     stream.~   "
105941|NCT01670474|"~     Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified~     film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive~     polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was~     reduced in the modified catheter compared with standard catheter. The clinical investigation~     revealed that both number of days before catheter removal according to clinical requirements~     and number of treatments per catheter were significantly higher with the modified catheter~     as compared with the standard catheter.~      Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter~     thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause~     bleeding, as well as the morbidity and mortality associated with catheter malfunction and~     infection, justify the need for more definitive evidence of the efficacy of rt-PA as a~     locking solution.~      No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD)~     uncuffed catheters survival.~   "
105942|NCT01670461|"~     Advance Care Planning (ACP) prepares patients and their loved ones for future health care~     decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients~     for participation in ACP, despite its priority, is not well studied. Our goal is to test a~     model of ACP that anticipates these issues, fully empowers the family and adolescent, and~     keeps the key role of health care professionals central, building on our earlier work. We~     hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment~     preferences between adolescents and surrogates; (2) decrease decisional conflict for~     adolescents; and (3) increase quality of communication compared with controls.~   "
105943|NCT01670448|"~     Pain after breast cancer surgery could be severe and about 1/3 of patients will develop~     chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral~     muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of~     this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor~     and major breast surgery. The prevention of chronic pain following surgery will also be~     evaluated.~   "
105944|NCT01670435|"~     This study is a post-marketing surveillance in Japan, and it is a local prospective and~     observational study of patients who have received Ciproxan intravenously as a first-line~     treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical~     or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The~     objective of this study is to assess safety and efficacy of Ciproxan in daily clinical~     practice. A total of 3,000 patients are to be enrolled and assessed during the period of~     treatment with Ciproxan.~   "
105945|NCT01670422|"~     Clinically, recurrence and life-threatening complications are challenging problems for~     chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report~     about the causes of or risk factors for the two problems. Doctors identify the causes or~     risk factors only through clinical experience. The investigators performed a retrospective~     study of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors~     for the above mentioned two problems were analyzed by logistic regression analysis. The~     investigators found that some of the patients' general conditions, including age, admission~     temperature, admission white blood cell count, pre-admission antibiotic administration~     without consultation, location of the lesion, and general patient condition, were the risk~     factors. The results indicate that doctors should be mindful of those risk factors and that~     the management should be more aggressive when the above risk factors are present.~   "
105946|NCT01670409|"~     The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year~     local control and overall survival rates in patients with esophageal squamous cell carcinoma~     receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.~   "
105947|NCT01670396|"~     The investigators hypothesized that genetic variants of G protein influence the development~     of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).~   "
105948|NCT01670383|"~     The objective of this study is to find a new therapeutic strategy by investigating the~     serial serum samples of patients with sepsis or postresuscitation state.~   "
105954|NCT01670305|"~     Residual pockets and furcation defects are challenging sites that require additional~     periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic~     therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of~     PDT in association with scaling and root planing (SRP) in class II furcation lesions with~     probing pocket depth (PPD) >5mm and bleeding on probing (BoP). A blind randomized controlled~     clinical trial was conducted in subjects presenting at least three residual pockets in~     single root teeth and subjects with at least one molar presenting class II furcation defect.~     To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected~     sites were assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate~     the effect of PDT in association with SRP in class II furcation lesions, the selected sites~     were assigned to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic~     analyses were assessed at baseline, 3 and 6 months post-therapies.~   "
105955|NCT01670292|"~     This is a biomechanical study which is Project 1 in the Developmental Center for Clinical~     and Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01;~     principal investigator Christine Goertz, DC, PhD). This study is designed to monitor both~     physiological and patient self-report outcome variables. In addition, as there is little~     quantitative information on Spinal Manipulation Technique procedures reported in clinical~     trials, the study is designed to collect preliminary kinetic measures of the spinal~     manipulation technique delivery (i.e. force-time profiles).~   "
105956|NCT01670279|"~     The purpose of this study is to assess the safety and tolerability of ascending multiple~     oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with~     MDD.~   "
105957|NCT01670266|"~     The primary objective of this study is to evaluate the safety and tolerability of 3 planned~     doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension~     (OHT) or mild open angle-glaucoma (OAG).~      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the~     pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its~     tolerability following morning and evening dosing.~   "
105958|NCT01670253|"~     The primary objective is to investigate whether intake of approximately 200 ml of sugary~     fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of~     fasting period for patients without reducing the quality of the study.~      Current standard for fasting and fluid intake before gastroscopy is completely fasting 6~     hours before the study. Studies in patients in general anesthesia has been found that it~     does not increase the risk of aspiration of stomach content during the operation by allowing~     the patient to drink up to 2 hours prior to anesthesia induction. There are no studies that~     have examined the quality gastroscopy using this fasting procedure. Some studies show that~     intake of sugary liquids do not have significant effect on gastric emptying.~      There are not deemed to be ethical problems with this study, as it seeks to show that a more~     lenient standard procedure in endoscopy is as safe as the established. The study is~     considered safe.~   "
105959|NCT01670240|"~     This study wants to investigate the efficiency of biological treatment for chronic~     pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon,~     a pouch. It is examined in patients with ulcerative colitis.~      The primary objective evaluation is to evaluate the clinically effect of biological therapy~     (adalimumab) in patients with chronic pouchitis.~      Secondary objective is to evaluate the effect of biological therapy on the endoscopical and~     histological inflammatory activity.~      It is a double-blinded randomized placebo controlled study.~   "
105960|NCT01670227|"~     The purpose of this study was to determine whether ParentCorps promotes academic achievement~     and prevents mental health problems in children living in disadvantaged urban communities~   "
105961|NCT01670214|"~     Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of~     migraine or decrease them even in the patients with refractory migraine.~   "
105962|NCT01670201|"~     The investigator will identify the test donor site and test location will be considered on~     the upper anterior thighs as being the most suitable if available. Circumferential donors~     will be considered acceptable as well.~      Treatment will be initiated in the operation room following debridement and split thickness~     grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and~     dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked~     lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be~     applied directly to study site. Secondary dressing will include covering with ace wrap.~      Healing should be asses after 10-14 days.~   "
105963|NCT01670188|"~     Determine if the use of sequential pneumatic compression in the arm can prevent the~     formation of venous clots related to the presence of a peripherally inserted central~     catheter (PICC).~   "
105964|NCT01670175|"~     This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and~     topotecan. This is the first study to evaluate the safety and clinical activity of the~     combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and~     young adult patients with relapsed and refractory solid tumors.~      In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with~     oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid~     tumors. The primary aim of this study is to recommend a phase II dose schedule and describe~     the toxicity of this combination. Myelosuppression will be a targeted toxicity.~   "
105965|NCT01670162|"~     The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept~     injection in a population of neovascular AMD patients that have been previously treated with~     2.0 mg ranibizumab for persistent PEDs.~   "
105966|NCT01670149|"~     Clostridium difficile associated diarrhoea is an important cause of morbidity in patients~     treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of~     initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a~     poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan~     to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin~     given in a reducing dose over 4 weeks after successful treatment will reduce the relapse~     rate.~   "
105967|NCT01670136|"~     The purpose of this study is to learn more about the safety and dosing of sildenafil in~     infants.~   "
105968|NCT01670123|"~     This three-year intervention development proposal is submitted to the NIMH DATR Mood~     Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this~     study is to further develop and then evaluate the clinical utility of a new personalized~     smart-phone intervention to enhance illness self-management in people with bipolar disorder.~     Bipolar disorder is a heterogeneous fluctuating condition and a leading source of~     disability. Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to~     clinical management and evidence-based psychosocial interventions for bipolar disorder.~     Practice guidelines state that all patients should receive education in self-monitoring and~     identifying adaptive responses to early warning signs and symptoms. Advances in technology~     have enabled electronic monitoring of patient-reported outcomes using mobile devices - an~     assessment strategy called Ecological Momentary Assessment (EMA). Using freely available~     software, we have developed a preliminary version of a novel smart-phone intervention that~     integrates EMA with brief psychosocial intervention designed for people with bipolar~     disorder. Mobile real-time interventions have been successfully applied in other chronic~     illnesses and have theoretical advantages over clinic-based interventions in motivating and~     cuing health-protective behavior. Our new intervention is called Personalized Real-Time~     Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content~     naturalistically at the moment that symptoms occur. We recently conducted a small~     proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the~     intervention is feasible, presents no technological or operational barriers, yields data~     that corresponds with clinical ratings, and is perceived as useful by participants. Building~     from our preliminary work, we propose to further develop the intervention based on~     participant feedback and theoretically-driven enhancements. We will then conduct a~     randomized trial to assess the clinical utility of this new intervention over 12 weeks.~     Specifically, we will randomize a sample of 90 adults aged 18 and older with Bipolar~     Disorder I or II to one of two experimental conditions. Participants in both conditions will~     participate in two in-person sessions adapted from an evidence-based psychosocial~     intervention for bipolar disorder, aimed at identifying early warning signs and adaptive~     responses to symptom fluctuations. The Control condition will participate in the in-person~     sessions, and the PRISM condition will also utilize the smart phone device for 12 weeks. In~     this pilot trial, we will compare outcomes between the two conditions on standard clinical~     ratings of depressive and manic symptoms, along with psychosocial functioning. We will~     assess predictors of compliance and changes in outcomes in the PRISM condition to inform a~     larger effectiveness trial. We will use exploratory analyses to further refine the~     intervention, including capitalizing on the rich repeated measures obtained by the device.~     This study will provide a strong basis for a larger effectiveness trial, along with a~     potentially useful tool to enhance self-management in bipolar disorder. PUBLIC HEALTH~     RELEVANCE: Bipolar disorder is a leading cause of disability, and many people do not have~     access to evidence-based psychosocial interventions. Mobile devices may prove more effective~     than clinic-based interventions, because they deliver self-management strategies at the~     moment that symptoms occur. To lead to a larger effectiveness study, we propose to further~     develop our novel intervention uses mobile technology to monitor and intervene with symptoms~     in real-time, and then conduct a 12-week randomized trial in 90 patients to evaluate the~     acceptability and short-term efficacy of our smart-phone based intervention for bipolar~     disorder.~   "
105970|NCT01670097|"~     The goal of this clinical research study is to learn if dexamethasone can help reduce~     shortness of breath in cancer patients. Researchers also want to learn if it can help to~     improve lung function and quality of life. In this study, dexamethasone will be compared to~     a placebo.~      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help~     patients with shortness of breath.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
105971|NCT01670084|"~     In this study researchers want to find out more about the side effects of a new drug for~     Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic~     myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to~     nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD~     is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin~     (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only~     for patients with cluster of differentiation [CD]20 positive disease). Researchers don't~     know all the ways that this drug may affect people~   "
105972|NCT01670071|"~     The purpose of this study is to compare the effect of oral paliperidone extended-release and~     oral risperidone immediate-release on cognitive function, especially the category fluency of~     Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an~     established diagnosis of schizophrenia.~   "
105973|NCT01670058|"~     -  The prevalence of Belatacept use~        -  The characteristics of Belatacept users and the temporal trends in these~          characteristics~        -  Characteristics of adult kidney-only transplant recipients who are treated with~          Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the~          time of transplantation, and the temporal trends in these characteristics during 7~          years post approval of Belatacept.~   "
105974|NCT01670045|"~     This multi-center observational study will evaluate the use and efficacy of~     RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis.~     Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label~     will be followed for 6 months.~   "
105975|NCT01670032|"~     This study will be a multicenter, randomized, vehicle controlled, parallel, group, double~     blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to~     one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel~     applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments~     will be administered for 7 days. Disease activity for the Target Lesion will be evaluated~     using the Skin Infection Rating Scale (SIRS) Score.~   "
105976|NCT01670019|"~     This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing~     antidepressant treatment in patients with major depression who have not had a complete~     therapeutic response to treatment with the antidepressant alone.~      The investigators hypothesize that added asenapine will produce greater reductions in~     depression than will added placebo.~   "
105977|NCT01668966|"~     This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01649804)~     will evaluate the safety and efficacy of tocilizumab in participants with early moderate to~     severe rheumatoid arthritis who have completed the 104-week WA19926 (NCT01649804) core~     study. Eligible participants will be those who are expected to benefit from the study~     medicine based on the investigator's discretion.~   "
105978|NCT01668953|"~     Tennis elbow is the most common cause of lateral elbow pain, generally caused by either~     work or sports related repetitive strain. In this condition, a tendon along the outside of~     the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.~      Many treatments have been attempted, including physiotherapy and steroids, with little~     success. One treatment which has been very effective is the injection of the patients own~     blood (taken from their other non-affected arm) into their abnormal tendon. The blood~     recruits the patients own healing factors and heals the damaged tendon. As platelets are~     thought to be largely responsible, injection of concentrated platelets, extracted from the~     patient's blood (platelet rich plasma) is a newer, but expensive, technique.~      At this point, it is unclear whether whole blood, concentrated platelets, or simply passing~     a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue~     healing (tendon fenestration) is the better treatment.~      The objective of this trial is to compare platelet rich plasma, whole blood, dry needle~     tendon fenestration, and sham injection (with physical therapy) to identify the best and~     most cost-effective therapy for this debilitating condition.~   "
105979|NCT01668940|"~     The primary objective of this study is to assess the effectiveness of Lillipops in the~     improvement of morning sickness symptoms. Secondary objectives are to assess if there are~     any changes to concurrent symptoms that may intensify NVP, such as metallic taste or~     gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas), as well as~     preference for freezie flavours.~   "
105980|NCT01668927|"~     The increase of antibiotic resistance to H. pylori causes failure of treatment.~     Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since~     resistance to these three antimicrobials was rare. It is necessary to assess the efficacy~     and safety of these four bismuth-containing quadruple regimens with above antibiotics as~     empirical rescue therapies for H. pylori eradication.~   "
105981|NCT01668914|"~     In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage~     is another important lymphatic channel of the breast. The status of IMLNs also provides~     important prognostic information for breast cancer patients. The technical evolvements of~     sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for~     assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was~     performed in the patients with clinically negative axillary nodes. However, previous~     published studies concerning patients with breast cancer who all underwent a radical~     mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary~     metastases. For this reason, IM-SLNB is even more important for clinically axillary~     node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early~     breast cancer patients with clinically positive axillary nodes.~   "
105982|NCT01668901|"~     In this study, the investigators examine whether aspirin or warfarin is useful for atrial~     fibrillation patients with chronic kidney disease.~   "
105983|NCT01668888|"~     Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related~     disorders such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue~     functions as a major endocrine organ by adipokine mediated modulation of a number of~     signaling cascades in target tissues, that has pro-inflammatory or anti-inflammatory~     activities. Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the~     investigators tried to clarify the clinical meaning of these two adipokines in the subjects~     with or without metabolic syndrome~   "
105984|NCT01669993|"~     The purposes of the study are to identify 1) the patient (demographic and clinical) and~     health care system factors predictive of immediate and late postoperative adverse outcomes~     in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep~     questionnaire to identify children at risk for immediate and late postoperative adverse~     outcomes in children undergoing tonsillectomy.~   "
105985|NCT01669980|"~     This is a study of safety and effectiveness of ceftaroline fosamil in children with~     Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.~   "
105986|NCT01669967|"~     Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic~     pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is~     good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the~     management of neuropathic pain in the short term - up to six hours.~   "
105987|NCT01669954|"~     The purpose of this study is to determine the bone mineral density in male and female~     patients with HIV infection according to age groups.~      This will enable a practical approach to screening for osteoporosis and the management and~     prevention of fragility fractures in people with HIV.~      In addition, all risk factors commonly associated with fragility fractures and osteoporosis~     are collected, as is HIV drug history.~      Hence, as secondary outcomes, the associations with reduced bone mineral density can be~     ascertained.~   "
105988|NCT01669941|"~     Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of~     maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy~     (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals~     in the second and third trimesters of pregnancy irrespective of the presence of malaria~     parasitemia, is currently recommended for HIV-negative women in all areas with stable~     moderate to high transmission of malaria. Due to increasing resistance to SP, it is no~     longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be~     decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for~     IPTp, as well as to explore the strategy of intermittent screening and treatment in~     pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused~     antenatal care (FANC) with treatment of women who screen positive.~      The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a~     reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in~     an area with decreasing malaria transmission and high levels of SP resistance in Kenya.~   "
105989|NCT01669928|"~     A randomised crossover trial of anti-hypertensive medication dosing regimen in effective~     blood pressure control.~      To investigate whether there is a difference in 24 hour blood pressure (BP) control when~     antihypertensive medications are taken in the morning compared with the evening. The~     identification of any significant difference could lead to more effective therapeutic~     management of arterial hypertension, which in turn would result in a reduced cardiovascular~     burden, lower costs and a better quality of life for hypertensive patients.~   "
105990|NCT01669915|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and~     will examine whether vitamin D or fish oil is associated with cognitive decline in 3000~     older participants of VITAL.~   "
105991|NCT01669902|"~     This multicenter observational study will evaluate the use of RoActemra/Actemra~     (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis~     unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will~     be followed for 6 months.~   "
105992|NCT01669889|"~     This multi-center, non-drug study will explore the relationship between exploratory~     biomarkers and functional dimensions in male adult individuals with Autistic Disorder or~     Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of~     assessments on study visit Day 1.~   "
105993|NCT01669876|"~     To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect~     on blood levels of amyloid beta (Aβ), or impacts global or functional measures of~     Alzheimer's Disease (AD) in subjects with mild to moderate AD.~   "
105994|NCT01669863|"~     Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute~     respiratory failure~   "
105995|NCT01669850|"~     The purpose of this study is to determine whether handsewn anastomosis versus clipped~     technique is associated with more complications, fistula failures, surgical cost and~     surgical time.~   "
105996|NCT01669837|"~     Prospective, multicenter, observational registry to collect data of laparoscopic inguinal~     hernia repair using surgical tissue glue fixation. The objective is to determine the~     prevalence of chronic pain at 1 year.~   "
105997|NCT01669824|"~     In this non-interventional one year study, data about overall and particularly~     gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are~     collected by basic questionnaires, which are handed out by pharmacists to patients who~     acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter)~     Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study.~     After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to~     get information about safety, usage and compliance under everyday's conditions, because in~     Germany low-dose aspirin is an OTC product with Rx indication.~   "
106095|NCT01668459|"~     A study for patients with confirmed locally advanced or metastatic Transitional Cell~     Carcinoma of the bladder or upper urinary tracts who have developed progressive disease~     within 12 months of their platinum based chemotherapy. The study aims to compare the overall~     response rate of cabazitaxel treatment versus best supportive care including single agent~     chemotherapy.~   "
105998|NCT01669811|"~     This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study~     to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H)~     20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory~     reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by~     assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los~     Angeles (LA) classification~   "
105999|NCT01669798|"~     The main purpose of this study is to see if BIBF 1120 can increase the number of women with~     bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not~     progress for at least six months.~   "
106000|NCT01669785|"~     The study is intended to verify through clinical measurement that the NUPRO Sensodyne~     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended~     relief up to 28 days.~   "
106001|NCT01669772|"~     DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These~     plants have been used in oriental traditional medicine for the treatment of gastrointestinal~     maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in~     functional dyspepsia patients and proved to have comparable safety and efficacy. However,~     its' exact effect on the gastrointestinal motility has not been completely elucidated. This~     study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.~   "
106002|NCT01669759|"~     The purpose of the present study was to investigate the correlation between the severity of~     fatigue, and the severity of qi deficiency and blood stasis.~   "
106003|NCT01669746|"~     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and~     female subjects with hair loss.~   "
106004|NCT01669733|"~     The purpose of this research is to study the effect music has on women undergoing surgical~     breast biopsy. Through the facilitation of live and/or recorded music listening, we will~     examine the perception of patient anxiety, the total amount of propofol required to obtain a~     BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the~     effect of live and/or recorded music on patient satisfaction. It is hypothesized that:~        1. Patients in the live and recorded music groups will experience less anxiety than the~          non-music (standard care) group.~        2. Patients in the live and recorded music groups will experience a reduction in the~          amount of anesthesia needed to reach a state of moderate sedation compared to the~          non-music (standard care) group.~   "
106005|NCT01669720|"~     The main purpose of this study is to evaluate if aflibercept can reduce the chance that~     metastatic (spread of) colorectal cancer can grow back after finishing standard treatment.~     The study will also look at the side effects of aflibercept and the effect on quality of~     life.~   "
106006|NCT01669707|"~     The purpose of this study is to determine whether Endostar pumping into vein with~     Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly~     in the treatment of Non-Small Cell Lung Cancer (NSCLC).~   "
106007|NCT01669694|"~     This study is collecting serum and urine samples at various time points during pelvic floor~     physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines~     and proteomics at various time points.~   "
106008|NCT01669681|"~     The severe asthma is a major source of expenses in term of public health, while it concerns~     no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations,~     care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort~     of more than 500 severe asthmatic patients multicentrique in an already widely established~     cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime~     opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a~     real medical economic variable. The possibility of dynamic follow-up of the expenses~     compared to the medical data offers perspectives of evaluation cost-efficiency of the~     informed therapeutic procedures. It is possible to couple in a forward-looking and dynamic~     way the data of health stemming from a cohort with the economic data stemming from the CPAM.~     This variable included in a Cluster's algorithm has to allow to identify the interventions~     the more and the less cost effective. The main objective of this study is to realize a cost~     estimate of care of the severe asthma. The variation of the costs will be also studied. The~     recruited patients are patients already included in the cohort COBRA in the centers of~     Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.~   "
106009|NCT01669668|"~     This phase II trial studies how effectively radiofrequency ablation prevents recurrence of~     hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency~     ablation uses a high-frequency, electric current to kill tumor cells.~   "
106010|NCT01669655|"~     To characterize nutrient levels in breastfeeding infants and their mothers.~   "
106011|NCT01669642|"~     The purpose of the study is to find the dose of rapidly administered ketamine in 3 different~     pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction.~      Ketamine is the most common drug administered to children to facilitate painful procedures~     in the emergency setting because it achieves potent sedation, pain relief and amnesia with~     minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6)~     associated with standard ketamine administration guidelines(7) strains work flow because it~     requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and~     valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl~     (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation~     despite more frequent respiratory depression, apnea and hypotension caused by this~     technique.(2,4,8,9)~      The investigators believe recovery associated with our novel method for administering~     ketamine is significantly shorter than with the standard larger dose more slowly~     administered ketamine technique(7). Through the investigators clinical experience, the~     investigators have found rapid infusion of smaller than standard doses of ketamine safely~     achieves the drug's sedative effect, with the benefit of more rapid recovery due to the use~     of a smaller dose. However, this novel technique challenges published beliefs that time of~     recovery from ketamine sedation does not differ significantly with the dose administered,~     within the usual dose ranges, and that rapid infusion may cause respiratory depression,~     similar to that seen with other classes of sedative-analgesic drugs.(7,10) the investigators~     believe the slow infusion recommended by standard guidelines(7) requires a larger ketamine~     dose necessary to achieve effective sedation, and, consequently, prolongs recovery. It is~     the prolonged recovery that has prompted increased use of other less safe but briefer~     sedatives, such as propofol/fentanyl. By demonstrating patients recover rapidly with new~     ketamine technique, without increased adverse cardiopulmonary effects, the investigators~     will provide clinicians with an important new method for ketamine procedural sedation. The~     investigators believe clinicians will prefer more rapid recovery ketamine technique because~     it is safer and reduces pain and distress better than the propofol/fentanyl combination for~     sedation.~      The investigators complete proposal requires two steps. In Step One, this proposal, the~     investigators will determine the minimum effective dose of rapidly infused ketamine that~     achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of~     patients will be studied: one group is patients undergoing abscess incision and drainage and~     the other group is patients undergoing fracture reduction in our Emergency Department. The~     investigators believe that the ED95 is different for both the groups as the severity of pain~     is different. The investigators will compare the safety and recovery times to published~     standard ketamine techniques. In the following study, Step Two, the investigators will~     compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose~     determined in Step One to the standard ketamine technique to determine if the novel~     technique results in significantly shorter recovery without an increase in the frequency of~     adverse effects. The study the investigators are proposing in this submission is Step One~     only.~   "
106012|NCT01669629|"~     This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a~     primary hypothesis of comparing the handling of each lens. Additional secondary markers are~     measured looking at subjective comfort and vision of the lenses.~   "
106013|NCT01669616|"~     The primary objective of the trial is to collect SCOUT DS, random capillary glucose and~     Hemoglobin A1c measurements from subject 18 years of age or older.~   "
106014|NCT01669603|"~     The study is designed to assess the effect of ingestion of a probiotic on innate and~     adaptive host responses to rhinovirus infection.~   "
106015|NCT01669590|"~     The goal of the research project is to determine how aging and inactivity reduce the muscle~     anabolic effect of nutrients and lead to muscle and functional loss. The central hypothesis~     is that aging reduces mTORC1 signaling and the expression of skeletal muscle amino acid~     transporters in response to anabolic stimulation leading to reduced muscle adaptation to~     increased intracellular amino acid requirements. The investigators further hypothesize that~     inactivity exacerbates this effect with significant muscle and functional loss, and~     rehabilitation restores muscle signaling, metabolism and function to baseline values.~   "
106016|NCT01669577|"~     Prospective observational trial searching for independent predictors of mortality. Data was~     collected at trauma scene, ER, three and 24 hours of hospital stay.The patients will be~     followed for 30 days after hospital admission.~   "
106412|NCT01664104|"~     This observational, multi-center study will evaluate the treatment regimen, treatment~     responses and safety of RoActemra/Actemra (tocilizumab) therapy in a routine clinical~     practice in patients with moderate to severe rheumatoid arthritis. Data will be collected~     for 6 months.~   "
106017|NCT01669564|"~     This study will evaluate a new tool, based on our currently implemented Functional~     Assessment Screening Tablets (FAST), and activate patients to partner with their~     physicians. Completion of this project, FAST-PRI, will provide important information on the~     effectiveness of using HIT patient feedback to inform and activate patients and promote~     health behavior change.~      Aim 1 Hypotheses: Patients who receive self-management support through HIT patient feedback~     (intervention) will be more likely than patients who do not receive such feedback (control)~     to:~        -  Initiate discussions with their provider regarding study-designated PRI;~        -  Have discussions with their providers, regardless of the initiator, regarding~          study-designated PRI; and~        -  Perceive these discussions of study-designated PRI to be useful. Approach: We will~          conduct a 12-month randomized controlled trial of HIT patient feedback, clustered at~          the physician level, in an academic group medical practice. Patients and providers will~          complete questionnaires regarding discussions of health behaviors and HRQoL at each~          clinical encounter.~      Aim 2 Hypotheses: HIT patient feedback will result in: 1) increased number of smoking quit~     attempts, 2) increased physical activity, and 3) improved mental HRQoL at six, and twelve~     months.~      Approach: Patient participants will complete questionnaires regarding smoking quit attempts,~     physical activity, and their mental HRQoL at baseline, six and twelve months.~      Aim 3 Hypotheses: For each study-designated PRI, patients who receive HIT patient feedback~     will: 1) receive more treatment recommendations (e.g., nurse educator, pharmacist, social~     worker referrals); 2) act on more treatment recommendations; and 3) exhibit improved~     self-efficacy regarding their ability to make positive lifestyle changes and improve their~     HRQoL; physicians whose patients receive HIT patient feedback will have higher self-efficacy~     regarding their ability to influence their patients to make positive lifestyle changes and~     improve HRQoL. These, in addition to discussions (Aim 1), will mediate the relationship~     between HIT patient feedback and improvements in study-designated PRI.~      Approach: We will survey patients and physicians and abstract referral data from the~     electronic medical record (EMR).~   "
106018|NCT01669551|"~     This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or~     transesophageal echo in patients with structural and valvular heart disease who are already~     scheduled to undergo a percutaneous intervention. Specifically those patients would be those~     scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac~     catheterization assessment of aortic stenosis and those undergoing transcatheter aortic~     valve replacement.~   "
106019|NCT01669538|"~     This is a randomized, double-blind, placebo-controlled study to test whether a medication~     called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces~     cognitive problems that smokers experience during a quit attempt.~   "
106020|NCT01669525|"~     The purpose of this study to determine if measurement of maternal serum biomarkers and~     evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy~     outcomes.~   "
106021|NCT01669512|"~     ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been~     studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are~     inactivated viruses which have been modified so that they cannot reproduce in humans.~     Genetic information has been added to make them express proteins of the malaria parasite so~     that they stimulate an immune response against malaria. This trial examines whether a~     compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at~     preventing malaria.~      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to~     vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The~     objectives are to assess the safety of the vaccines when combined with Matrix M™, and to~     determine what effect Matrix M™ has on the immune responses to the vaccines.~      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA~     METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring~     them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of~     Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six~     volunteers will receive the vaccines alone as a comparison group. We will also look at what~     effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.~     Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical~     Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have~     blood taken to monitor safety and measure immune responses to vaccination, and be monitored~     for symptoms/side effects from vaccination.~   "
106022|NCT01669499|"~     Cancer patients with pain due to bone metastases are often treated with external irradiation~     in order to reduce pain. However, patients may experience a temporary increase of pain~     shortly after irradiation, a so-called pain flare. This study investigates whether a short~     course of a drug called dexamethasone may prevent the occurrence of a pain flare. Patients,~     who are irradiated for painful bone metastases are randomized into three groups. Group 1~     receives placebo during four days, group 2 receives dexamethasone on the day of the~     irradiation and placebo during three days, and group 3 receives dexamethasone during four~     days. All patients complete a questionnaire on pain, side-effects of treatment and quality~     of life during 14 days and after four weeks. This study will define whether dexamethasone~     decreases the occurrence of a pain flare after irradiation for painful bone metastases, and,~     if so, whether four days of treatment with dexamethasone is better dan one day of treatment.~   "
106023|NCT01669486|"~     The purpose of this research is to find the best system for assessing the pain of critically~     ill patient in Intensive Care Unit (ICU).~      At first the investigators assess the sedation of the patient with the scale~     sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the~     patient is too sedated or delirious the investigators consider him unable to use the Visual~     Analogic Scale (VAS).~      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT)~     and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been~     evaluated in three different moments: before, during and after the nurses' care.~      The investigators compare the scales between them. Then, every time the investigators value~     the score of these scales with the self-report of patients with the VAS scale (when it is~     possible) and finally with the physiological parameters (blood pressure, heart rate and~     respiratory rate).~      In the end, the investigators compare two different classes of patient: the surgical and~     medical one. The investigators search for some differences in the perception of the pain~     between these two classes.~   "
106024|NCT01669473|"~     This study seeks to evaluate a low-literacy strategy in a primary health care setting for~     promoting safe and effective prescription medication use among English and Spanish-speaking~     patients with diabetes.~      The investigators hypothesize that in comparison with patients receiving standard care, the~     patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate~     better understanding of how to safely dose out their medication regimen; 2) have fewer~     discrepancies in their medication lists; 3) take their medication regimen more efficiently;~     4) have greater adherence to their medication regimen.~   "
106025|NCT01669460|"~     The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce~     fatigue in prostate cancer patients receiving LHRH agonist therapy.~   "
132740|NCT01317706|"~     To compare the ultrasonographic cervical length with the Bishop score in determining the~     administration of prostaglandin for preinduction cervical ripening in nulliparas at term.~   "
106027|NCT01669434|"~     Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and~     including the morning of an intermediate risk surgery will experience more intraoperative~     hypotension than those who hold their chronic ACEI perioperatively.~      Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and~     including the morning of an intermediate risk surgery will experience better postoperative~     control of hypertension than those who hold their chronic ACEI perioperatively.~      Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and~     including the morning of an intermediate risk surgery will experience less acute renal~     failure than those who hold their chronic ACEI perioperatively.~      Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less~     than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a~     significant decrease in blood pressure during anesthesia compared to those who have a~     preoperative systolic blood pressure greater than 110 who are continued on their chronic~     ACEI.~      Secondary research hypothesis #4: Patients above the age of 64 who are continued on their~     chronic ACEI therapy perioperatively will have a significant decrease in blood pressure~     during anesthesia compared to those aged 64 or younger who are continued on their chronic~     ACEI.~   "
106028|NCT01669421|"~     The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop~     lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin~     (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing~     the deficient AAT serum levels just above a predetermined safety threshold of 11 uM.~     However, normal levels of AAT are between 25-50 uM.~      AAT has shown not only to inhibit lung proteases such as neutrophil elastase, but also to~     modulate inflammation. Given that many subjects with AATD who receive augmentation therapy~     still have significant lung disease and inflammation, this study will evaluate whether~     doubling the dose to 120 mg/kg/week has an effect in decreasing lung inflammation.~      Only the dosing of 60 mg/kg /week has received FDA approval. FDA has granted an IND number~     to this study to test the higher dose of 120 mg/kg/week.~      The study will evaluate systemic (serum) and pulmonary (bronchoscopy samples)markers of~     inflammation in 3 phases: standard dose (4 weeks), double dose (4 weeks) and standard dose~     (4 weeks).~   "
106029|NCT01669408|"~     Elevated body temperature was shown to be associated with worse outcome in acute stroke~     patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital~     cooling with cold infusions in stroke patients.~   "
106030|NCT01669395|"~     The purpose of this study is to investigate the effect of an early, coordinated~     rehabilitation intervention for patients with severe heart failure in NYHA class III and IV~     with a ejection fraction of <40% of normal cardiac function measured on frequency of~     readmissions, physical ability and participation in activities of daily living and quality~     of life.~   "
106031|NCT01669382|"~     Background:~      Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve~     patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions~     (PCI). Despite higher complications rates in earlier studies, current data suggest similar~     complication rates or better outcomes after the use of VCD as compared to manual~     compression. ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA)~     plug which occludes the puncture channel. Whether the use of this extravascular closure~     device is as effective as the more widely used plug/anchor mediated devices, has not been~     evaluated so far.~      We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the~     extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor~     mediated AngioSeal system.~      Methods:~      304 patients receiving diagnostic angiography and/or PCI will be included in three centers.~     Exclusion criteria are contraindications for any VCD including 1. severe calcification of~     the access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the~     profound femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the~     femoral or iliac artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on~     continuous medication with oral anticoagulants.~      After the procedure, angiography of the accessed femoral artery is performed to rule out~     major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the~     common or the superficial femoral artery, or a location of the puncture site in the~     bifurcation of the profundal femoral artery.~      We hypothesise, that the use of an extravascular closure device is not inferior to an~     anchor/plug mediated device regarding the occurrence of the following complications:~     bleeding, need for vascular surgery and device failure (primary endpoints). Secondary~     endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm~     within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be~     defined according to the TIMI criteria. The study is actively enrolling patients, last~     inclusion will take place in September 2012.~      Results and Conclusions:~      Outcome data including the primary endpoint (bleeding, need for vascular surgery and device~     failure) will be presented for the first time.~   "
106032|NCT01669369|"~     The purpose of this study is to determine whether Lithium Carbonate combined with~     neo-adjuvant chemotherapy improve the prognosis of osteosarcoma~   "
106033|NCT01669356|"~     Malnutrition is common in esophagus cancer patients, especially after surgery therapy.~     Whether parenteral supplement with enteral nutrtion is benificial for patients after~     esophagectomy is controversial, when compared with enteral nutrition alone. In this study,~     the investigators are to examine the effect of enteral nutrition supplemented with~     parenteral nutrtion on nutrition status after esophagectomy.~   "
106034|NCT01669343|"~     The purpose of this study is to examine how key patient factors, including body size affect~     how well letrozole suppresses circulating estrogen levels.~      This study has two components: (1) Part A - an observational phase to evaluate the impact of~     vitamin D and obesity on estrogen suppression in post-menopausal women already receiving~     letrozole treatment, and (2) Part B - an interventional phase for women with body mass index~     (BM) > 25 kg/m2.~      If BMI or other patient factors reduce the effectiveness of letrozole, modifications to~     treatment recommendations and studies to test higher dosing of letrozole may be needed to~     maximize the benefit of this treatment and minimize the risk of the breast cancer coming~     back.~   "
106035|NCT01669330|"~     The most widely used operative technique for gastroesophageal reflux is total fundoplication~     where the gastric fundus is sutured around the distal esophagus like a wrap. This operation~     effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms~     related to over-competence of the gastroesophageal junction. 40% of the operated patients~     experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative~     technique where the distal esophagus is anchored to the crura of the hiatus esophagi and~     only a part of the front wall of the esophagus is covered with fundus. An anterior~     fundoplication is un attempt to create a more physiologic reflux control and less functional~     problems postoperatively. The aim with this study is to compare the results postoperatively,~     both short time and long time results.~   "
106036|NCT01669317|"~     This study is designed to demonstrate that cherry juice is effective in treating insomnia,~     and to show that it works by inhibiting an enzyme that will be measured in the blood.~   "
106037|NCT01669304|"~     Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo,~     unsteadiness and dizziness. Clinical investigators are studying these illnesses to~     understand them better. VM and CSD occur together in about 1/3 of patients. That makes it~     hard to diagnose them accurately and decide what treatments to use. As a result, doctors and~     patients may be confused about these diagnoses. The goal of this study was use two different~     medications to tease apart the symptoms of VM and CSD.~      Patients who have VM and CSD together were given either verapamil or sertraline for 12~     weeks. These medications are used to treat VM and CSD, though they are not approved for this~     purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is~     believed to have stronger effects on symptoms of CSD. By comparing the responses of patients~     to these two medications, the researchers hoped to learn more about the key features of VM~     and CSD.~   "
106038|NCT01669291|"~     The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long~     protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for~     assisted reproduction affects IVF outcome, peak estradiol level, and duration of~     stimulation.~   "
106039|NCT01669278|"~     The processing of standard flexible nasopharyngoscopes is a time-consuming and costly~     process. The goal of this study is to determine the efficiency and cost-effectiveness of~     sheathed flexible endoscope in an office setting.~   "
106040|NCT01669265|"~     This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early~     breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by~     one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.~      The aim of the present study is to assess the intraoperative positive SLN total tumor load~     (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN~     metastasis in patients with clinically node-negative early-stage breast cancer.~   "
106041|NCT01669252|"~     This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory~     pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with~     operable Stage III HER2 non-overexpressing breast cancer.~   "
106042|NCT01669239|"~     This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of~     neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients~     with HER2-positive breast cancer~   "
106043|NCT01669226|"~     The purpose of this study is to evaluate the role of an additional intraperitoneal~     chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.~   "
106044|NCT01669213|"~     The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3~     receptor antagonists on prevention of hypotension after spinal anesthesia~   "
106045|NCT01669200|"~     The primary aim of this study is to assess whether daily dosing with medium chain~     triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive~     performance.~   "
106046|NCT01669187|"~     It is expected that patients who receive physical therapy before surgery will have greater~     range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and~     anxiety following surgery compared to those in the control group.~   "
106047|NCT01669174|"~     This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of~     BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh~     muscle volume compared to placebo. The study will last for approximately 24 weeks.~   "
106048|NCT01669161|"~     Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.~     Patients will be randomized to one of two groups - a group implanted with a device that~     allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no~     implant). Patients have two baseline evaluations, one evaluation after implant but before~     initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,~     followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of~     treatment. The intent is to assess safety and provide preliminary effectiveness information~     for VNS for upper limb functional improvement after stroke. Implanted patients may receive~     longer-term treatment and follow-up after the acute study.~   "
106049|NCT01669148|"~     The primary hypothesis to be tested is:~      Detection of breast cancer will be increased with tomosynthesis (3D) imaging.~   "
106050|NCT01669135|"~     The cerebral oxygen saturation is assessed by means of near-infrared spectometry in~     parturients undergoing cesarean delivery under spinal anesthesia. The investigators~     hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.~   "
106051|NCT01669122|"~     This is a randomized, single center, open label, single dose, four way crossover study in~     fasted healthy male subjects to compare the pharmacokinetics of nicotine following~     administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg~     nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12~     hours post dose in each treatment session and plasma samples analyzed for nicotine levels.~   "
106052|NCT01669109|"~     Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing~     techniques, and meditation. It is used in India since centuries to improve well-being and~     cope with diseases and is gaining more and more interest in Europe and the US. While studies~     have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on~     patients with colorectal cancer are available yet. The purpose of this study is to~     investigate the effect of Hatha Yoga in patients with colorectal cancer.~   "
106053|NCT01669096|"~     The purpose of this study is to assess the safety and immunogenicity of two doses of the TB~     vaccine administered according to a 0, 1 month schedule. In, addition, blood samples~     collected at different time points after vaccination will be analysed to see when exactly~     genes are activated by the vaccine using an assay called mRNA expression profiling. The~     different methods for mRNA expression profiling using whole blood samples versus Peripheral~     Blood Mononuclear cell(s) (PBMCs), will also be compared.~   "
106079|NCT01668667|"~     Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently~     approved in the United States for the treatment of adults with moderate-to-severe primary~     Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy,~     tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already~     approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to~     severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a~     condition of the approval of HORIZANT tablets (NDA 022399).~   "
106054|NCT01669083|"~     GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst~     implantation in women undergoing IVF treatment. This study will be the first dosing~     experience with this compound in women. It is important to characterize the pharmacokinetics~     of GSK557296 in women to determine the most appropriate doses and dosing regimens for future~     clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable~     more accurate characterization of any exposure-response relationship in future studies.~      Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10~     milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced~     embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging~     study to characterize the pharmacokinetics of GSK557296 in women to determine the most~     appropriate doses and dosing regimens for future clinical studies.~      This is a non-randomized, open label, adaptive design study in healthy female volunteers. A~     maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1~     will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow~     for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will~     receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive~     based on the requirement of additional doses to be studies after PK data will be analyzed~     from each of the first 2 cohorts.~   "
106055|NCT01669070|"~     The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram~     (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI~     containing FF formulated with lactose. In addition, the aim of this study is to determine~     the absolute bioavailability of the FF single strip product using the high strength product~     administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV)~     FF.~      This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult~     subjects. During each period, subjects will receive FF in the morning and serial~     pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days~     for the IV treatment) and safety assessments will be performed. Each period will be~     separated by a washout period of at least 7 days and a follow-up telephone call will occur 7~     -14 days after the last dose of study drug. The total duration of the study will be~     approximately 13-14 weeks for each subject.~   "
106056|NCT01669057|"~     The objective of this study is to investigate the effect of parental peri-natal~     environmental risk factors and genetic factors on the development of Congenital Heart~     Disease (CHD). Our hypothesis is that the distributions of some environmental and genetic~     risk factors significantly differ between neonates with and without CHD.~   "
106057|NCT01669044|"~     The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic~     qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be~     easily roused, these advances shows dexmedetomidine may be a effective and safe sedative~     agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics~     (such as bradycardia, hypotension), the investigators want to further research the effects~     of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance~     Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely~     effects like bradycardia and hypotension, so the investigators want to compare the effect of~     dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to~     further research the mechanism of haemodynamics of dexmedetomidine.~   "
106058|NCT01669031|"~     Unreliability and visual field variability is a known problem with automated perimetry in~     both developing and developed country settings. This study will look at the effects of a~     computer program that allows new patients to practice the visual field exam before taking~     the actual exam. Our hypothesis is that the intervention group will have less variability as~     measured by mean deviation between exams and greater reliability as measured by the standard~     unreliability indexes of false positive rate, false negative rate, and fixation losses.~   "
106059|NCT01669018|"~     Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of~     nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a~     relevant technique in patients with severe cardiac comorbidity. The technique is a safer~     alternative compared to general or spinal anesthesia in these fragile patients.~      The most recognized technique with ultrasound guidance (Karmakars technique) is technically~     demanding and based on injection of local anesthetic relatively close to the exit of the~     spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal~     prompting a risk of low blood pressure. This may be fatal in high risk patients.~      The investigators have developed a simple technique based on injection away from the spinal~     canal. The investigators expect minimal risk of spread of local anesthetic to the spinal~     canal with this technique.~      This randomized, double blinded trial compares the new technique to the established~     technique of ultrasound guided blockade of the lumbar plexus.~      The hypothesis is that the new technique has a higher success rate with reduced effect on~     blood pressure for ultrasound guided lumbar plexus block compared to the established~     technique.~   "
106060|NCT01669005|"~     Objectives: Invasive infections are the leading cause of morbidity and mortality in patients~     treated for hematological malignancies. Blood cultures are often negative in neutropenic~     patients because of low-burden of organisms, previous antibiotic therapy or non-infectious~     reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.~      Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before~     febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for~     multiplex PCR at admission and 3x/week thereafter until discharge or recovery from~     neutropenia~   "
106078|NCT01668680|"~     Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy~     which may be toxic +/- exhausting are candidates for an effective and more convenient~     maintenance treatment.~      Objectives:~        1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM)~          regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.~        2. To discover predictive factors for response to this LDM regimen.~      Hypothesis:~        1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of~          LDM chemotherapy.~        2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation~          of certain enzymes in the tumor may discover predictive factors of response to LDM~          chemotherapy in metastatic CRC patients.~   "
106061|NCT01668992|"~     The study will evaluate the impact of a family-based intervention on the well-being of~     Burmese migrant and displaced children and families living in Tak province, Thailand. The~     methodology used in the impact evaluation study is a randomized waitlist controlled trial.~      The study hypothesizes that participation in a family-based intervention will lead to~     improved parenting practices and child and family outcomes, as follows.~      Primary hypotheses:~        1. Parents/caregivers participating in the family-based intervention will report increased~          knowledge and use of positive parenting skills compared to control;~        2. Parents/caregivers participating in the family-based intervention will report less use~          of physical punishment and other harsh forms of discipline compared to control;~        3. Parents/caregivers and children participating in the family-based intervention will~          report higher levels of family functioning and cohesion compared to control.~      Secondary hypotheses:~        1. Parents/caregivers and children participating in the family-based intervention will~          report lower levels of externalizing and internalizing child behaviors compared to~          control;~        2. Parents/caregivers and children participating in the family-based intervention will~          report higher levels of child resilience and psychosocial well-being compared to~          control;~        3. Parents/caregivers participating in the family-based intervention will report lower~          levels of alcohol use compared to control.~   "
106062|NCT01668979|"~     The study is aimed to assess a new system for the automatic detection, quantification and~     treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The~     system is comprized of a treadmill and a virtual reality simulation which provides a~     motor-cognitive challenge to provoke NF. The challenges provided by the system are~     individualized and using machine learning algorithms will enable the identification and~     detection of NF under different conditions and allow for the most suitable treatment.~   "
106063|NCT01668875|"~     The purpose of this study is to explore acute hemodynamic and ventilatory responses to~     head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal~     injury in the traumatic intensive care unit.~   "
106064|NCT01668862|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy~     of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The~     study is being conducted in 2 centers in India. The primary end points are Visual Analog~     Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint~     is improvement in ultrasonography form randomization to End of study.~   "
106065|NCT01668849|"~     This study will evaluate the ability of grape exosomes, given to the subject as grape~     powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis~     during radiation and chemotherapy treatment for head and neck tumors.~   "
106066|NCT01668836|"~     Women have a natural protection that gives them greater longevity. One hypothesis most~     commonly used is the estrogen protection in the premenopausal period. However many studies~     of various forms of hormone replacement therapy proved ineffective in promoting additional~     protection for women. Thus, it is discussed other ways of protection associated with~     longevity in women. Of these, the sirtuin system was found in several animal studies to be~     associated with longevity. This system also showed, through the involvement of several~     metabolic pathways, an important protection against the process of atherosclerosis. But the~     activity of this system in humans is unknown and if it is more active in women than in men.~     The study's main objectives are to analyze this system in healthy 24 women and 24 men aged~     55 to 65 years, and their influence on the main metabolic pathways related to longevity and~     the process of atherosclerosis. The research protocol includes analysis of the influence of~     sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of~     inflammation and homeostasis, before and after the interventions with caloric restriction or~     resveratrol administration. It is expected of this study mechanistic conclusion for~     longevity and possible clinical applications in the mechanism of atherosclerosis prevention.~   "
106067|NCT01668823|"~     This phase I trial is studying the side effects and best dose of photodynamic therapy using~     HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH,~     that becomes active when it is exposed to a certain kind of light. When the drug is active,~     cancer cells are killed.~   "
106068|NCT01668810|"~     The investigators aimed to examine the psychotropic prescription pattern in China.~   "
106069|NCT01668797|"~     The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo~     as maintenance treatment in adults with schizophrenia.~   "
106070|NCT01668784|"~     The purpose of the study is to compare the clinical benefit, as measured by duration of~     overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic~     clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy~   "
106071|NCT01668771|"~     Background:~      - Self-affirmation is the process of reflecting on values that a person considers important.~     This process may encourage people to be more open to information about health risks. It may~     also encourage them to change their behaviors or lifestyle to decrease these health risks.~     Researchers want to look at the effect of self-affirmation on people s responses to new~     health risk information. Because recent studies have linked alcohol consumption to increased~     risk of breast cancer, the study will focus on alcohol s link to breast cancer.~      Objectives:~      - To study how self-affirmation can change opinions following a message about a health risk.~      Eligibility:~      - Women at least 18 years of age who drink at least two alcoholic beverages per week and/or~     at least three alcoholic beverages per sitting.~      Design:~        -  Participants will be recruited through an online panel. The study will be conducted~          entirely online.~        -  Participants will respond to two short studies. The first will ask about life events~          and how they make people feel. The second will look at how people respond to~          information about alcohol and breast cancer.~        -  For the first study, participants will write a paragraph or two about an important~          event in their lives. They will answer questions about how that event made them feel.~          They will also write a paragraph about an important personal value.~        -  For the second study, participants will read information about alcohol and breast~          cancer risk. They will then answer questions about this information. They will also~          answer questions about their beliefs about alcohol and breast cancer.~        -  Participants will receive financial compensation for being in this study.~   "
106072|NCT01668758|"~     Background:~      - The amount of blood flowing in brain areas goes up when those areas are being used for~     activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a~     common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also~     be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.~     Researchers want to compare fMRI and NIRS to see whether they give similar results. These~     studies will be used to look at people who have had a traumatic brain injury.~      Objectives:~      - To test how well NIRS measure changes in blood flow in the brain after a traumatic brain~     injury.~      Eligibility:~        -  Individuals between 18 and 60 years of age who have had a traumatic brain injury.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Researchers may~          ask to see brain images during from previous MRI scans.~        -  Participants will have a NIRS scan of the brain. They will be asked to do certain tasks~          while inside the scanner. These tasks will involve responding to images that appear on~          a screen.~        -  Treatment will not be provided as part of this study.~   "
106073|NCT01668745|"~     Background: All observational studies and a few randomised controlled trials (RCT) suggest~     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better~     effect on overall mortality than later MV. These results suggest that MV has a non-measles~     related beneficial effect on child survival.~      Objective: To evaluate in a multi-center RCT the effect on child survival and other health~     indicators of a two-dose measles vaccination schedule by providing an additional dose of~     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard~     measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and~     Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site~     separately and a 32% reduction overall. Based on the results from the RCT, the investigators~     will assess the cost-effectiveness of the intervention.~      Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance~     System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and~     campaign vaccinations will be collected regularly through home visits and health centre~     registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),~     the children will be eligible for enrollment in the trial if they are not severely ill.~     Eligible children will be invited to take part in the trial. Provided parental informed~     consent is given, the children will be randomised to MV at 4 and 9 months of age or only at~     9 months. Cost estimates will be based on consumption of services and average cost per unit.~     The incremental cost effectiveness ratio will be calculated.~      Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each~     site the investigators intend to enroll at least 4050 children in Burkina Faso. The children~     will be followed for survival and hospitalisations to 3 years of age or to the end of the~     study after three years. The investigators will analyse the effects by site and combined; by~     sex and season; possible interactions with other interventions like campaigns with drugs,~     vaccines or micronutrients will be explored.~      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of~     maternal antibody levels on subsequent antibody responses to MV. The children will be~     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.~   "
106074|NCT01668732|"~     Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and~     the society. Since the introduction of opioids substitutive treatment in 2006, more than~     30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment~     currently. However, an unknown proportion of patients hidden in community remained~     un-treatment. To motivate the community heroin addicts is thus a challenging task.~      It is suggested that decision making deficit is core feature which determine outcomes and~     treatment motivations in patients with addiction disorders. Recently, the state-of-the-art~     development of epigenetics uncover that environmental modification, via altering level of~     DNA methylation and gene expression will influence on neurocognitive functioning.~      Via respondent-driven sampling, this study aims to recruit a representative sample targeting~     at the hard-to-reach community heroin addicts. The goal of this study is to identify the~     clinical feature as well as decision making-related neurocognitive deficit in these~     patients. Moreover, the investigators will explore the interplay of clinical features, DNA~     methylation and gene expressions on opioids receptor genes. The findings will help to~     clarify the clinical characteristics of community heroin addicts, to uncover the links~     between DNA methylation and clinical features of heroin addiction and to develop modifiable~     treatment targets in the future.~   "
106075|NCT01668719|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     elotuzumab and to see how well it works when given together with lenalidomide, bortezomib,~     and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely~     to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth~     of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill~     cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving~     elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to~     block cancer growth.~   "
106076|NCT01668706|"~     Opioid abuse is a complex problem, which not only impacts on addicts' physical and~     psychological health individually, but also threats the society. Recently, spread of HIV via~     sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious~     public health problem all over the world. In Taiwan, since the first HIV-infected IDU~     identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the~     epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with~     Department of Justice and implemented harm reduction programs in 2005. It is the milestone~     that opioid addiction is officially treated as a health rather than a legal issue in Taiwan.~     Among the harm reduction programs of needle and syringe exchange for IDUs as well as~     substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one~     of the most important parts. Till 2008, there were over 13,000 heroin addicts participated~     in more than 80 MMT programs.~      Although the clinical evidences have proven the superior effectiveness of maintenance~     therapy in ameliorating illicit substances abuse, decreasing criminality and improving~     quality of life, there are common problems of sleep disturbance and neurocognitive~     impairments among the subjects receiving opioid medications. The concerns of the adverse~     effects might thus frustrate the subjects' motivation and compliance to maintain treatments.~     However, sleep disturbance and neurocognitive impairments related to opioid medications are~     often neglected in the clinical practices and there are scanty researches focusing on these~     crucial issues in the existing literature.~      In this prospective study, four groups of subjects including methadone maintenance~     treatment, buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers~     will be enrolled. Via the comprehensive assessments including clinical interview,~     neurocognitive examinations, electrocardiogram-based sleep breathing detector and~     pharmacogenomical evaluation, we will not only have the opportunities to have more insights~     on the impacts of opioid medications on sleep and neurocognitive performances, but also~     develop more adequate strategies to improve motivation and outcome in treating the opioid~     addicts.~   "
106077|NCT01668693|"~     The purpose of this study is to demonstrate the clinical efficiency of the Endometrial~     Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure~     (RIF), leading to the new concept of the personalized window of implantation (pWOI) as~     diagnostic and treatment of patients with RIF of endometrial origin.~   "
106080|NCT01668654|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset~     seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have~     participated in a previous (parent) study.~   "
106081|NCT01668641|"~     -  Ninety patients suffering from active rheumatoid arthritis despite continued treatment~          with methotrexate will be evaluated for improvement of disease activity when taking~          GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur, and the amount of GLPG0634 present in the blood as well as the effects~          of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be~          determined.~   "
106082|NCT01668628|"~     The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal~     dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and~     depression over time.~   "
106083|NCT01668615|"~     The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are~     effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).~   "
106084|NCT01668602|"~     Stroke is the number one cause of disability. Difficulty with walking affects most stroke~     survivors. The focus of this project is to understand the effects of different methods (such~     as treadmill walking and electrical stimulation) that can be used to improve walking in~     people with stroke. In this study, patients with stroke and healthy people who have not had~     a stroke will be tested. Study participants will take part in 18 sessions of walking~     training. Walking patterns will be measured using automatic cameras and standard clinical~     tests. Also, magnetic brain stimulation maybe used to measure brain-muscle connections, and~     muscle stimulation may be used to measure spinal-cord circuits during the training. This~     research will provide information on how different factors that affect walking in stroke~     change with walking training. The investigators hypothesize that improvements in brain~     excitability of the muscles targeted by walking training will occur after training, and~     these changes in brain excitability will be related to improvements in walking patterns. By~     improving our understanding of walking rehabilitation, this study can help improve walking~     function and disability in people with stroke.~   "
106085|NCT01668589|"~     The main objective of this observational study was to describe medication-taking behavior of~     patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.~   "
106086|NCT01668576|"~     The major limitation to long term survival in lung transplant recipients is the development~     of graft failure over time, termed bronchiolitis obliterans. The conventional therapies used~     to prevent rejection are not effective in preventing bronchiolitis obliterans. Therefore,~     new therapies are needed to address this problem. A growing body of research has focused on~     a unique population of bone marrow cells termed Mesenchymal Stem Cells (MSCs) to improve a~     range of medical conditions including heart failure, autoimmune disease, and inflammatory~     bowel disease. MSCs can prevent animal models of bronchiolitis obliterans. Because of this~     information, it is plausible that MSCs could help patients as a potential treatment in lung~     transplantation.~      This proposal will test the immunologic properties of MSCs generated from such individuals~     to answer the question of whether generation of whether it would be feasible to use such~     cells in the future to prevent entities such as bronchiolitis obliterans.~      The Investigator will approach patients who are being considered for a lung transplant~     because of end stage lung disease. Enrolled patients will undergo a bone marrow aspiration~     where a small amount of fluid is removed from their pelvic bone. Cells obtained in this~     procedure will be expanded in the Emory/Georgia Tech Cell Lab. MSCs will be expanded in this~     lab using cell culture conditions which are standardly used for MSCs.~   "
106087|NCT01668563|"~     The purpose of this study is to compare the clinical outcome of surgical clipping and~     endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT~     Study.~   "
106088|NCT01668550|"~     The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl~     inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the~     treatment of advanced solid tumours~   "
106089|NCT01668537|"~     A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and~     safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox~     vaccine in vaccinia-naïve healthy subjects~   "
106090|NCT01668524|"~     This single-site, dose-escalation study will evaluate safety and tolerability of increasing~     concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular~     Hypertension~   "
106091|NCT01668511|"~     To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with~     osteoarthritis of the knee.~   "
106092|NCT01668498|"~     80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab)~     experience skin toxicity, mostly acne like skin rash.~      A standardized treatment of skin rash is neither established as standard arm for clinical~     trials nor as guideline for the treatment of skin toxicity in clinical practice. While an~     improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best~     supportive care the data basis for patient related outcomes regarding skin toxicity deriving~     from randomized trials is still small.~      Recent surveys among German oncologist revealed that physicians are reluctant to use oral~     antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are~     thinking about using preemptive treatment in patients with acne-like skin rash.~      Thus, in the present trial two main questions will be addressed:~      (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin~     treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case~     of inefficacy = development of acne) without compromising treatment efficacy of skin~     toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment~     arms.~   "
106093|NCT01668485|"~     Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic~     control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if~     insulin independence is not achieved. However, the extent and underlying metabolic pathways~     of this improvement are unknown. Investigators therefore compare systemic glucose turnover~     including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring~     islet transplant recipients, matched type 1 diabetic subjects who did not receive islet~     transplantation, and matched healthy non-diabetic subjects.~   "
106094|NCT01668472|"~     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as~     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart~     review after delivery.~   "
106097|NCT01668433|"~     The emergence of partial artemisinin resistance in Plasmodium falciparum on the~     Cambodia-Thai border and more recently on the Myanmar-Thai border jeopardizes the renewed~     global efforts of control and elimination of malaria. Containment of this severe threat~     requires reduction of transmission of the resistant phenotype by adding gametocytocidal~     drugs to the treatment of falciparum malaria. Mathematical models also predict that~     transmission blocking will be required if the goal of malaria elimination is to be achieved.~     The only drug currently available with strong gametocytocidal properties against the more~     mature gametocytes is primaquine. However, the oxidative properties of primaquine readily~     causes acute haemolysis in glucose 6 phosphate dehydrogenase (G6PD) deficiency, the degree~     of which appears to be inversely related to G6PD enzyme activity. Because of these safety~     concerns, primaquine is not widely deployed in treatment regimens for falciparum malaria,~     even in areas with documented artemisinin resistance. Methylene blue, which does not exert~     its action through an oxidative mechanism, is a promising alternative as a gametocytocidal~     adjuvant to artemisinin combination therapies (ACTs). Paul Ehrlich discovered methylene blue~     as the first synthetic drug ever to treat malaria. In contrast with primaquine, the thiazine~     dye methylene blue asserts its properties as an oxidizing agent only at very high doses,~     whereas at pharmacologic doses it has reducing agent properties and is for this reason used~     as a medication for the treatment of methemoglobinemia. A recent laboratory study identified~     methylene blue as a potent inhibitor of gametocyte development across all stages, almost~     fully abolishing P. falciparum transmission to mosquitoes at concentrations readily~     achievable in humans. In addition, a recent clinical study in 180 children with~     uncomplicated falciparum malaria in Burkina Faso showed that, compared to~     artesunate-amodiaquine alone, addition of the cheap drug methylene blue to either artesunate~     or amodiaquine importantly reduced gametocyte carrier rates measured at days 3, 7, and 14 of~     follow-up. This effect was seen both in patients with and without P. falciparum~     gametocytaemia at baseline. The current series of studies will investigate further methylene~     blue as a potential gametocytocidal drug in the treatment of uncomplicated falciparum~     malaria.~   "
106098|NCT01668420|"~     The thermal stimulation have been proven effective in upper extremity of stroke patients.~     Therefore, this study explored the efficacy of thermal stimulation in lower extremity of~     stroke patients.~   "
106099|NCT01668407|"~     The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease~     (PD) such as exercises has been demonstrated; in particular an example for patient tailored~     exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to~     maintain their maximum level of mobility, activity, and independence. Several systematic~     reviews and clinical studies have shown that physical therapy can contribute to minimize the~     disabling effects of motor and sensory impairments in order to enhance participation in~     societal roles and quality of life. The use of electromechanical devices such as treadmill~     training (a supplement to conventional therapies) in the last years has also been used with~     PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the~     effectiveness and acceptability of treadmill training in the treatment of gait disorders for~     patients with PD. In the last years new robotic assisted device can be used in gait training~     in neurological disorder. Till now only few studies, have focused on the effects of~     exoskeleton or end effector robot-assisted training in PD patients, with a interesting~     preliminary results.~   "
106100|NCT01668394|"~     Background: It is well known that cardiac rehabilitation has potential to reduce morbidity~     and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the~     effect of a new patient education method called learning and coping strategies to that of~     standard care.~      Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly~     hospitalised with either ischaemic heart disease or heart failure.~      Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac~     rehabilitation with addition of learning and coping strategies which include participation~     of experienced patients as co-educators, clarifuing interviews, and inductive teaching~     style.~      Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.~      Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors,~     lifestyle, health related quality of life.~   "
106101|NCT01668381|"~     The purpose of this study is to determine the enumeration and function changes of regulatory~     t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks~     after ablation therapy.~   "
106102|NCT01668368|"~     Patients with acute respiratory failure exhibiting decreased respiratory system compliance~     with hypoxemia or carbon dioxide retention are often difficult to ventilate with current~     guidelines that limit applied plateau pressure Yet, these guidelines do not take into~     consideration chest wall mechanics. The investigators sought to determine whether partition~     of the respiratory system into its components by measuring esophageal pressure and thus~     assessment of pleural pressure, would help in patients with acute respiratory failure to~     identify the factors contributing to low respiratory system compliance.~   "
106103|NCT01668355|"~     People with serious mental illness have difficulty making good use of primary care, and die,~     on average, years earlier than others in the population. The greatest contributors to this~     premature mortality are medical illnesses, especially cardiovascular disease and cancer. The~     Patient Centered Medical Home is a model for reorganizing primary care practice so that~     healthcare is more effective, efficient, and user-friendly. It has been implemented across~     VA as the, Patient Aligned Care Team (PACT). It is unclear, however, how this PACT model~     applies to people whose predominant illness is treated by specialists. This is the case for~     people with serious mental illness (SMI), many of whom receive ongoing treatment at mental~     health clinics. To achieve optimal health outcomes in the population with SMI, it may be~     necessary to adapt the PACT model so that it includes approaches that have proven to improve~     healthcare in this population. This project implements an adapted SMI-PACT model, and~     evaluates its effect on Veterans with SMI.~   "
106104|NCT01668342|"~     Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms~     are common post-injury, and few MTBI patients receive treatment or follow-up for these~     symptoms. Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly~     common form of communication, potentially allowing for accurate assessment of symptom~     patterns after MTBI and provision of basic education support . The investigators seek to~     assess the feasibility of using SMS to collect symptoms related to MTBI in patients either~     discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek~     to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14~     days and whether additional SMS-based educational feedback alters daily symptom patterns.~   "
106105|NCT01668329|"~     Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its~     outcome has not been improved despite the knowledge on inflammatory processes; a reason for~     these lack of results may lay on the lack of data on the precise dynamics of inflammatory~     and anti-inflammatory cascades and their consequences. We intend to achieve accurate~     monitoring of the inflammatory process on a small group of non-immunocompromised patients.~     Our goal is to obtain quality data, repeated over time, by limiting the technical~     variability.~   "
106107|NCT01668303|"~     The objective of the proposed study is to adapt and implement an efficacious adolescent~     substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug~     court service system. Additionally, the investigators will also examine the extent to which~     MDFT can enhance the effectiveness of existing juvenile drug court services in terms of~     decreasing drug use, delinquent behavior and arrests and improving school and vocational~     outcomes. The study design is a fully randomized controlled trial.~   "
106108|NCT01668290|"~     Patients who present with chest pain are investigated with tests designed to confirm or~     exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor~     outcome. It is not known which imaging test would be best when used first for investigating~     a patient presenting with exertional chest pain. This trial is designed to compare outcomes~     of the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot~     study. Patients with no history of coronary disease presenting with chest pain will be~     randomly assigned to one of the three test modalities as the initial imaging test. The three~     imaging strategies will be compared regarding the subsequent use of healthcare resources~     over a year.~   "
106109|NCT01668277|"~     Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure~     in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions~     expand the circulating volume, thus allowing more blood to flow and reducing pressure in the~     artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to~     reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular~     resistance decreases more or to the same degree as the systemic resistance, infusion of~     hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis.~     The primary objective of this study is to investigate how a clinically relevant dose of~     hypertonic saline affects the systemic and pulmonary circulations in children undergoing~     cardiac catheterization during general anesthesia. This study hypothesizes that an infusion~     of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than~     the systemic vascular resistance.~   "
106110|NCT01668264|"~     Diastolic function is poorly studied in children with congenital heart disease. This is~     mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared~     to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue~     characterization. The main advantage of echocardiography is a better temporal resolution~     which allows the study of short events like early relaxation. Overall there is a lack of~     studies correlating different echocardiographic and MRI parameters of heart function in~     pediatric populations with congenital or acquired heart diseases. This study will address~     specific questions on specific groups of patients that might bring more insight into chamber~     interaction and cardiac function. This study hypothesizes the following:~        -  Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo~          might be the best method for follow-up.~        -  Cardiac remodeling associated with chronic loading results in changes in diastolic~          properties related to changes in cardiac mass and volume. This is related to changes in~          cardiac mechanics influencing diastolic parameters. Especially the influence on~          twisting and untwisting will be studied.~        -  Regional myocardial fibrosis and scarring may account for regional systolic and~          diastolic dysfunction with possible prognostic impact~   "
106111|NCT01668251|"~     The goal of this study is to compare the features of Turner syndrome in girls who are~     diagnosed before birth because of fetal concerns versus those who are diagnosed when their~     mother has an amniocentesis for another reason.~   "
106112|NCT01668238|"~     The purpose of this stage of study is to establish discriminant among healthy tissue, benign~     and malignant thyroid and breast tumors by fourier transform infrared spectrometry~     variables.~   "
106113|NCT01668225|"~     Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of~     this molecule is increasing in reproduction pathology. High level of follicular and blood~     G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation~     rates.~   "
106114|NCT01668212|"~     Perifollicular Doppler could reflect the quality of the follicle's vascularization and,~     consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the~     analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.~      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro~     Fertilization, between the quality of the vascularization and the one of the oocyte, the~     embryo and the pregnancy.~   "
106115|NCT01668199|"~     A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.~   "
106116|NCT01668186|"~     The Peroxisome Biogenesis Disorders (PBD) are a group of inherited disorders due to defects~     in peroxisome assembly causing complex developmental and metabolic sequelae. In spite of~     advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of~     phenotypes poorly characterized and the natural history not yet systematically reported. Our~     aims are to further define this population clinically, biochemically and genetically. The~     investigators will prospectively follow patients from Canada, the US and internationally,~     and collect data from medical evaluations, blood, urine and imaging studies that would be~     performed on a clinical care basis. Patients unable to attend clinics can participate in~     this study by mailing in their medical information. The investigators will use this~     information to identify standards of care and improve management.~   "
106117|NCT01668173|"~     The purpose of this study is to test a new drug called AUY922. AUY922 is not FDA-approved.~     AUY922 is a new kind of drug that attacks a protein called HSP90. HSP90 is found in both~     normal and cancer cells, but the investigators think it is more important in cancer cells.~      This study will see if AUY922 helps people with myelofibrosis, essential thrombocythemia and~     polycythemia vera. This study will also see if AUY922 is safe in people with myelofibrosis,~     essential thrombocythemia and polycythemia vera. It will find out what effects, good and/or~     bad, AUY922 has on the patient and the disease. The researchers hope that this study will~     help them to find better treatments for primary myelofibrosis, essential thrombocythemia and~     polycythemia vera.~   "
106135|NCT01667939|"~     Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial~     dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant~     mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide~     dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women~     submitted to an individualized diet during pregnancy.~   "
106118|NCT01668160|"~     The specific aim is to quantify the stability of the acetabular and femoral components of a~     revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In~     this way, the investigators will gain insight into the outcome of the current state of the~     art of revision arthroplasty surgery. In the past, acetabular and femoral component~     stability has been measured using radiostereometric analysis (RSA) and when patients having~     revision total hip operations were compared to patients undergoing primary total hip~     operations it was possible to determine differences in stability and this was predictive of~     the intermediate to long-term performance of the acetabular and femoral reconstruction. The~     investigators propose to use this established, high resolution technique to assess and~     compare the stability of the revision implants.~   "
106119|NCT01668147|"~     The purpose of this research study is to determine the effects of ritonavir and efavirenz on~     the activity of P-glycoprotein in human brain.~      Screening~      Health self-assessment and undergo a medical history and physical examination, including a~     structured interview to screen for history of medical conditions, fasting blood glucose and~     HIV blood tests, urine HCG pregnancy test for women of childbearing potential will be~     performed within 24hr of study drug administration~      Study visits Subjects will be studied on three occasions, with a washout between sessions.~     Sessions 1: Control (no pretreatment) - intravenous administration of 10 - 14 mCi of [11C]~     desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir~     for 3 days followed by intravenous administration of 10 - 14 mCi of [11C]dLOP with PET/CT~     imaging Session3: Pretreatment with oral efavirenz for 14 days followed by intravenous~     administration of 10 - 14 mCi of [11C]dLOP with PET/CT imaging~   "
106120|NCT01668134|"~     This study is being done to determine if targeted radiation therapy (stereotactic) can be~     given to treat liver cancer, for patient who are unable to undergo surgery, over a short~     period of time with a small amount of side effects.~   "
106121|NCT01668121|"~     The primary objective of this study is to evaluate the acceptance range with which two~     Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting.~     The secondary objective is to compare pharmacokinetic parameters of the reference product~     batches and Budesonide/formoterol Easyhaler.~   "
106122|NCT01668108|"~     The main purpose of this observational study with Paclitaxel is to determine the number of~     treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special~     circumstance of ambulant chemotherapy.~      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted~     packaging sizes as to decrease the excess quantity to be discarded follows also this~     objective.~      Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison~     to Docetaxel. To this purpose, data regarding co medications and adverse events are also~     collected.~   "
106123|NCT01668095|"~     This research trial studies tumor tissue to identify important proteins and biomarkers from~     patients with rhabdomyosarcoma that has spread to other places in the body and usually~     cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients~     with cancer in the laboratory may help doctors identify biomarkers related to cancer.~   "
106124|NCT01668082|"~     The study is designed to use infusion of a non-radioactive, naturally occurring isotope of~     glucose (13C) in patients undergoing surgical resection for a newly identified brain mass to~     obtain the metabolic phenotype of the tumor, and correlate it with the histopathological~     diagnosis. In each patient, 13C NMR spectral analysis of tumor extracts will be obtained~     after intraoperative infusion of [U-13C]glucose or [1,2-13C]glucose. Whenever feasible,~     patients will undergo 3 preoperative imaging studies - 18FDG-PET, diffusion tensor imaging~     with 1H-spectroscopy on 3T MR scanner, and ultra high resolution MR imaging on the 7T MR~     scanner. The results of these imaging studies will be correlated with the metabolic~     phenotype to generate a comprehensive non-invasive view of the tumor with the goal of~     identifying infiltrative, metabolically active tumor cells within the brain. In addition, a~     comprehensive molecular profile of the tumor will be obtained and enable a~     genotype-metabolic phenotype comparative analysis.~      Correlative Translational Research The investigators will obtain tumor tissue from each~     patient for comprehensive molecular analysis (array CGH, expression profiling, methylation~     profiling) which will be correlated with tumor histology, the metabolites identified by~     1H-MR spectroscopy and the 13Cglucose metabolic profile. Patients will be followed at~     designated time points along their treatment course to obtain information about ongoing~     treatment and response, time to tumor progression and overall survival. These parameters~     will be used in correlational analysis with the metabolic phenotype.~   "
106125|NCT01668069|"~     Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent~     in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first~     line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians~     and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are~     using ondansetron as first line in practice. Despite this practice and the recommendations~     from ACOG, there is not data to suggest that ether practice is superior. This will be the~     first prospective, randomized, double blind, controlled trial comparing the two treatments.~     We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes~     of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will~     likely benefit from less Emergency Department visits, urgent clinic visits, and admissions~     for progression to hyperemesis gravidarum.~   "
106136|NCT01667926|"~     Ketamine infusions resulted in an acute reduction in global depression scores and in~     severity of suicidal ideation. The investigators therefore plan to investigate the~     feasibility and efficacy of repeated intravenous administration of ketamine in severely~     depressed, treatment resistant patients. The results of the study could lead to development~     of new strategies for treating depression.~   "
106137|NCT01667913|"~     The purpose of this study is to examine the relative (ICC) and absolute intertester~     reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient~     facility. The data collection is conducted by two physiotherapists, who are blinded to each~     other. The physiotherapists are randomized so they each are doing an equal number of~     baseline tests.~   "
106345|NCT01665196|"~     This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT~     (positron emission tomography/computed tomography) in evaluation of patients with~     IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients~     with IgG4-related disease before and after treatment.~   "
106126|NCT01668056|"~     Ovarian stimulation is an important phase of in vitro fertilization (IVF) treatments. The~     harvest of a larger number of viable eggs per cycle compensate eventual laboratory~     difficulties and allow for the selection of embryos with higher implantation potential. In~     the current protocols, based on the most prevailing theory of ovarian follicular~     development, stimulation drugs are usually started on the second or third day after the~     beginning of menses. The follicular phase of the menstrual cycle is believed to be the only~     favorable moment for follicular development.~      In the early 2000's a new model of human ovarian follicular development (follicular waves)~     has been proposed based on frequent transvaginal ultrasound observations between two~     ovulations. It has been shown that ovarian antral follicles develop in synchronous groups,~     two to three times in a cycle. In fact the follicular wave phenomenon has been initially~     described in the 80's on domestic animals, like the mare and the cow. Moreover, studies in~     these animals have shown that synchronizing the start of the ovarian stimulation drugs with~     the beginning of a follicular wave yields better results for assisted reproductive~     treatments. Consequently in ovarian stimulation protocols for animal assisted reproduction~     it is important to control the initiation of a follicular wave.~      Current protocols of ovarian stimulation for IVF in women do not consider the start of a~     follicular wave to begin drug administration. Therefore the purpose of this study is to~     evaluate two methods to control the emergence of a follicular wave (ovulation induction and~     dominant follicle aspiration) and to investigate the effects of synchronizing ovarian~     stimulation for IVF with follicular wave emergence in women compared to one of the current~     stimulation protocols (flexible GnRH protocol).~   "
106127|NCT01668043|"~     The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting~     the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective~     when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected~     adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The~     neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive~     cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1~     infection.~   "
106128|NCT01668030|"~     Forty percent of patients admitted to the contributing regional burn unit over a five month~     period received facial burns (n=14). The purpose of this study is to examine if the time~     until a granulation bed is well established can be decreased be using an enzymatic agent,~     when compared to a second standard ointment, for patients with partial-thickness facial~     burns. The current study will use a prospective, experimental study design in which each~     individual will be their own matched control. That is, each individual will receive both the~     experimental ointment (one-side of the face) and the standard ointment (other-side of the~     face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation~     bed establishment) one ointment achieves in partial-thickness facial burns when compared to~     a second ointment. Exploratory analyses will examine the relationships among demographic~     variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That~     is, testing whether the time until granulation establishment may be associated with an~     individual's demographic variables, treatment type, pain, anxiety, itching levels, and~     scarring. Significance for all analysis will be at the 0.05 level. The investigators~     hypothesize that promoting rapid granulation bed establishment will decrease hospital length~     of stays, costs, risk of infection, and possibly associated appearance changes. The results~     from the current study will provide preliminary findings for a future, more sophisticated~     study.~   "
106129|NCT01668017|"~     This is a two-part trial. Solid tumor in this protocol means solid tumor excluding~     hepatocellular carcinoma (HCC).~      Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B).~     The dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the~     recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global~     studies for each arm independently.~      Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more~     subjects in Cohort A (N=18) and Cohort B (N=6) separately.~      Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued~     due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to~     this cohort. This decision is based upon review of safety and efficacy information.~   "
106130|NCT01668004|"~     The objective of this study is to determine the difference in the annual incidence rate of~     uveitis attacks in participants with ankylosing spondylitis (AS) before start initial~     anti-TNF therapy and after treatment with golimumab (GLM).~   "
106131|NCT01667991|"~     Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve~     the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are~     different between countries, will affect the accuracy of etiological diagnoses according to~     the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the~     accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria~     in China.~   "
106132|NCT01667978|"~     The purpose of this study is to learn if women taking the atazanavir and ritonavir have~     lower levels of a birth control medication called norethindrone. Norethindrone (also called~     the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth~     control pill used to prevent pregnancy. Norethindrone is the standard medication used in~     women who take the progestin only pill to prevent pregnancy. There are other birth control~     pills which contain different medications. The investigators want to learn if HIV~     medications (atazanavir and ritonavir) make the blood level of this birth control pill~     higher or lower. If the levels of norethindrone are too low it may not work to prevent~     pregnancy. The investigators also hope to learn about changes in the vaginal fluids and~     cervical fluids when women are taking this birth control pill.~   "
106133|NCT01667965|"~     The purpose of this study is to assess the effectiveness and acceptability of a recently~     created informative video geared for patients who have been evaluated by a radiation~     oncologist for palliative radiation therapy during a hospitalization at Memorial~     Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is~     given to patients with the purpose of easing symptoms from cancer. It is not given with the~     intent to cure the cancer. The video presents basic information about palliative radiation~     and palliative care.~   "
106134|NCT01667952|"~     The purpose of this study is to establish a registry of survivors of cancer, tumor, or a~     related illness.~   "
106138|NCT01667900|"~     This is a study of dulaglutide in Chinese participants. The purpose of the study is to~     determine how the body processes dulaglutide and how dulaglutide affects the body. This~     study has 2 parts: Part A - single dose of dulaglutide administered to healthy participants~     in 2 of 3 study periods. There is a minimum 28-day washout between periods. Part A will last~     approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants~     with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.~      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this~     study.~   "
106139|NCT01667887|"~     The objective of this study is to document callus formation and healing of fractures~     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled~     axial micro-motion to actively promote fracture healing.~   "
106140|NCT01667874|"~     The purpose of this study is to determine if Collatamp, a small flat sponge soaked with~     antibiotics will help to improve the success rate of the treatment of acute joint infections~     after a joint replacement surgery. Our hypothesis is that those patients receiving the~     Collatamp sponges will have an improved success with respect to the eradication of infection~     at one year following treatment.~   "
106141|NCT01667861|"~     The purpose of this study is to determine the impact of playing wind instruments for the~     development of ocular hypertension and glaucoma, together with investigating the prevalence~     of visual problems and eye diseases in (professional) musicians.~   "
106142|NCT01667848|"~     The purpose of this study is to determine the effect of warmed, humidified carbon dioxide~     Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.~   "
106143|NCT01667835|"~     The purpose of this randomized, control pilot study is to measure the effects of a gentle,~     12 week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk~     for cardiovascular disease. Hatha yoga is a form of structured physical exercises known as~     asanas, combined with breathing exercises called pranayama, and relaxation techniques. The~     yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing~     exercises (pranayama) that can be easily replicated and readily performed by individuals who~     are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.~   "
106144|NCT01667822|"~     Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily~     from mental health disorders, such as anxiety disorders and depression. Cognitive behavior~     therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the~     strong evidence for CBT there is a lack of evidence-based psychological treatment in primary~     care. For various reasons, the progress of research has not affected clinical practice. For~     successful implementation of CBT in primary care cost-effective therapies, access to~     therapists with proper training and supervision, evidence-based manuals and management that~     support the implementation is needed.~      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All~     patients are first treated with self-help CBT (N = 400). Patients that do not improve after~     treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based~     on published studies 2/3 is expected to be improved after self-help and therefore do not~     undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to~     individual CBT (N = 67) or continued self-help treatment (N = 67).~   "
106145|NCT01667809|"~     Background: Common mental illness, such as anxiety disorders and depression, is the main~     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be~     effective in alleviating target symptoms of these disorders, but its effect on sick leave~     rates has not been sufficiently addressed. The investigators have developed an intervention~     called return to work (RTW), which is based in cognitive behavioral theory, that has a~     primary aim of helping sick-listed patients with common mental illness return to work. This~     new treatment has not been evaluated in a randomized controlled trial.~      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical~     common mental illness in a randomized controlled trial conducted in primary care.~     Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes~     are days of sick leave and clinician severity rating of psychiatric symptoms. This study~     could contribute to new knowledge regarding how to best treat patients on sick leave with~     mild common mental illness.~   "
106146|NCT01667796|"~     This is a pilot study of oral vitamin D supplementation to determine if patients with~     Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum~     25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or~     relevant gene expression response to oral vitamin D supplementation differs in patients with~     MS and healthy controls.~   "
106147|NCT01667783|"~     Weight loss is effective in reducing many complications of obesity, with the majority of~     patients who undergo bariatric surgery having substantial improvements in their~     weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild~     to moderate obesity to compare how losing 10% of initial body weight via one of three common~     weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric~     bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do~     not expect this pilot study to provide definitive answers, it will provide valuable~     information to design a larger trial which will help guide therapy for people with~     mild-moderate obesity and substantial comorbidities.~   "
106148|NCT01667770|"~     This research study is to find out which types of dural grafts used during surgery for~     Chiari Malformations are superior. We believe that autologous dural grafts are superior to~     non-autologous grafts.~   "
106149|NCT01667757|"~     Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound~     imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)~     implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria~     satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or~     not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was~     proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous~     studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful~     predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging~     criteria defining as an indicator relieving myocardial ischemia were not reported. The aim~     of this study was to investigate angiographic and IVUS parameters in which corresponding FFR~     and evaluate their optimal physiologic criteria after DES implantation.~   "
106150|NCT01667744|"~     Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or~     emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary~     Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In~     addition, behavioral treatment of emotional distress is known to decrease symptoms, and~     treatment usage. The present protocol tests whether the addition of a medication known to~     reduce emotional distress can also reduce symptoms and treatment usage.~      This will done by recruiting patients with ACS during their hospital stay, randomizing them~     to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6~     months.~   "
106151|NCT01667731|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)~     plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are~     coinfected with HIV-1.~   "
106152|NCT01667718|"~     To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and~     without Bismuth for H.pylori treatment.~   "
106153|NCT01667705|"~     -  Rationale: Recently, research that demonstrates a clear relationship between the built~          healthcare environment and the health and wellbeing of patients has come available.~          Patients in a CT scan suite are usually anxious. The environment has been shown to~          lower stress; a painting or piece of art for example, can capture and hold attention~          and thereby lower negative thoughts and evoke positive emotions. Sights of nature have~          demonstrated to be especially effective in recuperating from stress, presumably because~          the human brain has evolved in a natural environment. The current study will~          investigate the effects of exposure to nature in the CT scan suite. A SkyCeiling, a~          large, slightly illuminated, photographic illusion of a real sky view is placed above~          the CT scan. The main hypothesis of this study is that a sky view will lead to a lower~          level of anxiety in the CT scan suite.~        -  Objective: The primary objective of this study is to examine the effect of a view of~          nature on a patient's stress and anxiety. Secondary objectives are to study the effects~          of a view of nature on a patient's environmental appraisals of the CT suite,~          satisfaction with the provided service, and trust in the healthcare provider.~   "
106154|NCT01667692|"~     The Aim of this study is comparison between two regimens containing clarithromycinand~     azithromycin.~   "
106155|NCT01667679|"~     This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally~     (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with~     migraine headaches in 30 minutes after use.~   "
106156|NCT01667666|"~     This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a~     preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human~     research indicate that aerosolized salt water might help reduce harmful inflammation with~     minimal risks.~   "
106157|NCT01667653|"~     This is randomized, double-blind, placebo controlled, single centre; 21 days phase II~     clinical trial on healthy volunteers. Following baseline visit at the day of randomization,~     treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic~     treatment subjects will also receive the study treatment, either probiotic or placebo. Daily~     Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect~     fecal samples for microbiological examination. The primary objective of the study is to~     evaluate the maintenance of intestinal microbiota composition during antibiotic treatment~     with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects~     associated with antibiotic use.~   "
106158|NCT01667640|"~     Microneurosurgical resection of intracerebral metastases leads to prolonged survival and~     relief of symptoms in selected patients.~      To minimize the risk of intracranial recurrence whole brain irradiation has been established~     as standard adjuvant treatment in those patients. Sector irradiation resembles a brain -~     tissue - sparing method by focusing the irradiation in the area of the tumor bed and a~     surrounding 1mm security margin.~      The aim of this study is to investigate whether adjuvant sector-irradiation following~     microsurgical resection is equal to adjuvant whole brain irradiation in terms of local~     control and superior to in terms of quality of life and neurocognitive deficits in a~     prospective randomized trial.~   "
106159|NCT01667627|"~     We present the study design of a clinical trial designed to assess the clinical effects of~     the multispecies probiotic combination BIO-25 in IBS-D patients. To this aim the primary~     endpoints of the study will be improvement in abdominal pain and stool consistency. The~     study will also be designed and powered to investigate the effect of the probiotic BIO-25 on~     the putative inflammation-associated parameters related to microinflammation in IBS, using~     postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional~     aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic~     status.~   "
106160|NCT01667614|"~     The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin~     converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.~     Recent evidence has provided robust evidence that aldostrone escape plays an important role~     in this regard. It is believed that aldostrone escape occurs quite commonly with reports~     indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial~     of patients with diabetes and hypertension it was shown that treatment of aldostrone escape~     with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number~     of other trials have similarly observed that addition of spironolactone to an ACE inhibitor~     based regimen provides additional benefits on proteinuria reduction, blood pressure control,~     and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in~     this regard are of short duration (e.g. three months), and have added spironolactone to an~     ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating~     efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS~     blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to~     determine the effects of addition of spironolactone 25 mg daily to losartan over a period of~     18 months.~   "
106232|NCT01666678|"~     The purpose of the current trial is to evaluate the bioavailability of a single oral dose of~     naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently~     marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets)~     or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.~   "
106161|NCT01667601|"~     Only a few intervention studies have also focused on changing patients' negative thoughts~     and feelings towards the illness and their relationship to the suffering caused by those~     thoughts, which is evidenced to empower psychosocial functioning and control of distressing~     thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress~     Reduction program. This controlled trial is designed to test the effects of a~     mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia~     on their symptom severity, illness insight and psychosocial functioning.~   "
106162|NCT01667588|"~     Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with~     a reported prevalence of 60-80%. To date three studies have reported on SDs in children with~     CKD but these have all been based on questionnaire data alone. The findings were not~     confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a~     validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is~     highly relevant given the poor sensitivity and specificity of even validated questionnaires~     alone. The effect of untreated pediatric SD is pervasive. This study will provide the first~     objective assessment of SDs using PSGs in children with severe CKD, both on and off~     dialysis. Therefore, we will recognize and when possible treat SD in this severe CKD cohort~     potentially contributing to their immediate management (eg improved control of hypertension,~     improved school performance), while improving their Quality of Life (QOL) and helping ensure~     they achieve their full potential.~   "
106163|NCT01667575|"~     The purpose of this study is to observe the efficacy of ten day triple therapy-based,~     bismuth-containing quadruple therapy for H.pylori treatment.~   "
106164|NCT01667562|"~     This open-label, multi-center study will evaluate the progression-free survival and safety~     of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer~     with activating mutations in the tyrosine kinase domain of the epidermal growth factor~     receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease~     progression or unacceptable toxicity.~   "
106165|NCT01667549|"~     The goals of the proposed research are to specify the timing and consequences of the~     sensitive period for flavor learning in infants who are being breastfed or formula fed. The~     investigators will conduct a randomized within- and between-subject study of women and their~     infants during a 15-month window.~   "
106166|NCT01667536|"~     This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and~     performance characteristics of MIP 1404 imaging in the detection of prostate gland and~     pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging~     and MRI were also assessed, as judged by histopathology results.~   "
106167|NCT01667523|"~     An altered permeability has been proposed to play an important role in the pathogenesis of~     several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel~     disease. Nutrients derived from food are able to influence the permeability of the intestine~     and can therefore also affect gastrointestinal symptoms. In this study, the investigators~     will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot~     peppers and cinnamon, respectively, on gastrointestinal physiology.~      Objective:~      To obtain more information about the effects of capsaicin and cinnamaldehyde on the~     intestine, these substances will be infused directly in the duodenum. Hereafter, the~     permeability of the intestine, gallbladder motility and the effects on satiety will be~     assessed.~      Hypothesis:~      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial~     barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin~     from enterochromaffin cells as determined by the multi sugar permeability test~   "
106168|NCT01667510|"~     Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded~     as having high blood pressure as defined in the most recent guidelines. From a physiological~     perspective, the regulation of blood pressure is a complicated process involving different~     biological systems and a number of feedback systems, including the nervous system, hormones,~     control of body fluid and regulators within the vessels themselves. In 90-95% of patients~     with high blood pressure the cause is unknown, whereas the remaining 5-10% may have~     secondary hypertension related to congenital heart defects, certain cancers or kidney~     abnormalities. Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood~     pressure (DBP) 80-89 mm Hg] is considered a precursor of hypertension and has been~     associated with an increased risk of up to 3.5 times in cardiovascular morbidity and~     mortality later in life.~      According the report of the Joint National Committee on High Blood Pressure (JNC 7) and~     other international guidelines, weight control, reduced intake of salt and reduced alcohol~     consumption, as well as increase of potassium are recommend nutritional approaches to~     prevent and treat hypertension. In observational studies significant inverse association~     between high blood pressure and vegetarian diet rich in fibers, magnesium, potassium,~     calcium and protein have been reported. In addition various studies demonstrated the ability~     of antioxidant vitamins of natural origin to improve vascular function.~      The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted~     Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension~     compared to Placebo.~   "
106169|NCT01667497|"~     Multiple Sclerosis (MS) patients often complain of cognitive fatigue. There is currently no~     treatment for this symptom. Fampridine SR is a recently approved medication that improves~     walking ability and walking speed in MS patients. It is thought that it might have the same~     positive effect on cognitive fatigue. This study will compare fampridine 10mg twice a day to~     placebo in order to determine if there is any benefit of this medication for cognitive~     fatigue in MS.~   "
106214|NCT01666912|"~     This is a prospective study comparing two groups of 48 adolescent women each. The~     intervention group will receive a contraceptive implant postpartum, prior to discharge from~     the hospital. The control group will receive a contraceptive implant at the usual 6 week~     postpartum clinic visit. During prenatal care, participants will be consented and screened~     for enrollment. After delivery, these women will be assessed and consented for enrollment~     into the study. Women who consent for enrollment will be randomized. Women will be followed~     up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At~     each follow up, women will be assessed for continuation of and satisfaction with this method~     of contraception.~   "
133192|NCT01311648|"~     The objective of the study is to demonstrate the safety and efficacy of treatment with~     BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.~   "
106170|NCT01667484|"~     Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis~     (MS) and can occur independently of physical disability. It is the most common reason, along~     with physical fatigue, for MS patients to stop working. The most frequent complaint is~     problems with multi-tasking or thinking quickly, which corresponds to impairment in the~     cognitive domain of processing speed. Currently there is treatment available to prevent~     relapses and physical disability but there are no medications that have been shown to treat~     cognitive impairment. Amphetamines have been beneficial for selective attention and~     processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain~     injury. This is study will determine whether Adderall XR improves objective measures of~     processing speed and attention in MS patients impaired in this cognitive domain, by~     comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication~     is administered. The results of this study will help provide data to design a larger study~     to determine if Adderall XR, and potentially other amphetamine drugs, will help treat~     cognitive impairment in MS patients.~   "
106171|NCT01667471|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical~     response to RoActemra/Actemra in the core study will be eligible to receive~     RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment~     is 104 weeks.~   "
106172|NCT01667458|"~     This observational study will evaluate the presence and evolution of fatigue on treatment~     with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid~     arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate)~     or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg~     intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.~   "
106173|NCT01667445|"~     The purpose of this study is to determine the contribution of spinal epimorph to patient's~     perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to~     determine whether spinal epimorph and its associated complications is a necessary addition~     to provide adequate analgesia given the multimodal approach to pain management. It is~     hypothesized that perioperative local infiltration with a cocktail of local and systemic~     analgesics will provide equal analgesia to patients who are given both local infiltration~     and spinal epimorph perioperatively.~   "
106174|NCT01667432|"~     This prospective, multicenter, observational study will evaluate on-treatment predictors of~     response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving~     treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the~     summary of product characteristics. Data will be collected from patients for the duration of~     their treatment and for up to 24 weeks thereafter.~   "
106175|NCT01667419|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF~     mutation-positive melanoma at high risk for recurrence. Participants will be randomized to~     receive oral doses of vemurafenib 960 milligrams (mg) twice daily or matching placebo. The~     anticipated time on study treatment is 52 weeks.~   "
106176|NCT01667406|"~     Infertility affects one in six couples in the United Kingdom (UK) and has devastating~     physical, social and emotional consequences for affected couples. In vitro fertilisation~     (IVF) treatment is now widely and successfully used to enable infertile couples to conceive.~     However, IVF treatment can result in the potentially life threatening condition, ovarian~     hyperstimulation syndrome (OHSS). Mild forms of OHSS occur in approximately 1 in 3 of all~     IVF cycles, whilst approximately 1 in 10 IVF cycles result in moderate or severe OHSS. OHSS~     is caused by the use of human chorionic gonadotrophin (hCG) used in IVF treatment to~     stimulate oocyte (egg) maturation. Kisspeptin is a hormone which stimulates reproductive~     hormone secretion and is responsible for the release of reproductive hormones which result~     in oocyte maturation and ovulation (the release of an egg from the ovary). The significant~     advantage of kisspeptin over current treatments to stimulate ovulation, is that it would~     stimulate a more physiological increase in reproductive hormones and oocyte maturation~     during IVF treatment. The aims of this project are to investigate whether administration of~     kisspeptin to women can result in oocyte maturation.~   "
106177|NCT01667393|"~     Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the~     IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive~     atherosclerotic popliteal artery disease.~   "
106178|NCT01667380|"~     This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene~     glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not~     on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of~     treatment.~   "
106179|NCT01667367|"~     This single-center, single-blind, placebo-controlled, parallel-group study with crossover~     component will evaluate the GABAAalpha5 receptor expression, occupancy and functional~     connectivity in the brains of individuals with Down syndrome and healthy controls following~     single dose RG1662. Participants will receive a single dose of placebo before the imaging~     session (PET and MRI), and a single dose of RG1662 before the second imaging session.~   "
106180|NCT01667354|"~     The primary aim of this trial is to test the effectiveness of an intervention to train~     primary care physicians to determine if it leads to decreased parental vaccine hesitancy.~   "
106215|NCT01666899|"~     The purpose of this study is to investigate the effects of radiation therapy following~     mastectomy on skin and blood vessels and to use information gathered to determine an ideal~     time for breast reconstruction after radiation.~   "
106228|NCT01666730|"~     This phase II trial studies how well metformin hydrochloride, leucovorin calcium,~     fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer.~     Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium,~     fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving metformin~     hydrochloride together with combination chemotherapy may kill more tumor cells~   "
106229|NCT01666717|"~     The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel~     Disease(IBD) patients versus healthy controls (HC).~   "
106181|NCT01667341|"~     Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts~     of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each~     cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:~        1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)~        2. GEN-003: Antigens alone~        3. Placebo (DPBS diluent)~      Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot~     Group. Immunization of the remainder of the Group Continuation Group) is contingent upon~     successful review of data from the Pilot Group through Day 7 after immunization. Dose~     escalation to the next dose level Cohort proceeds after evaluation of safety data from all~     patients in the prior Cohort and only after all specified safety criteria are met. The total~     numbers of patients in each Group and Cohort are as follows:~        -  10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)~        -  Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)~      Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo)~     at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be~     done twice daily for 28 days prior to the first immunization (baseline shedding), and again~     following the last immunization. Follow-up for safety monitoring will be conducted for 12~     months after the last immunization.~   "
106182|NCT01667328|"~     This randomized controlled interventional study is designed to determine whether breast~     cancer surgical patients receiving presurgical massage therapy performed by a licensed~     massage therapist have decreased average anxiety levels compared to the control group of~     breast cancer surgical patients who do not receive massage therapy.~   "
106183|NCT01667315|"~     The use of ultrasound in regional anesthesia enables reduction in the local anesthetic~     volume. The present study aimed to determine the minimum effective volume of 0.375%~     bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery.~     Following approval by the Research Ethics Committee, patients with a physical condition of I~     or II according to the American Society of Anesthesiologists, between 21 and 65 years old~     and subjected to elective surgery of the shoulder and interscalene brachial plexus block~     will be recruited. The volume of the anesthetic will be determined using a step-up/step-down~     method and based on the outcome of the preceding block. Positive or negative block results~     in a 1mL reduction or increase in volume, respectively. The success of the block is defined~     as the presence of motor block in two muscle groups and the absence of thermal and pain~     sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic~     paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours.~     Data will undergo statistical analysis in order to determine minimum effective volume of~     0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic~     function, evaluate diaphragm paralysis and its influence in pulmonary function.~   "
106184|NCT01667302|"~     The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy~     followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.~   "
106185|NCT01667289|"~     The purpose of this study is to prove the superiority of concurrent chemoradiation compared~     with radiotherapy alone in patients with low risk NK/T-cell lymphoma.~   "
106186|NCT01667276|"~     This is an observational study to assess the experience of current depot medroxyprogesterone~     acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject~     and offer recommendations for the introduction of this method.~   "
106187|NCT01667263|"~     Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus~     danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.~   "
106188|NCT01667250|"~     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled~     pilot study is to study feasibility and collect preliminary clinical data related to the~     safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the~     GammaCore device for the prevention of chronic migraine, and to support the development and~     approval of a larger pivotal study.~   "
106189|NCT01667237|"~     The general objectives of this study are to verify the feasibility of a short home-based~     rehabilitation program for cancer patients prior to lung resection surgery, and to quantify~     its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.~      Therefore, the hypotheses of this study are that:~        1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise~          training is feasible and safe in patients with lung cancer resection candidates.~        2. Compared to control patients, patients included in the home-based rehabilitation~          program will improve significantly their aerobic capacity, exercise tolerance and arms~          and legs muscle force.~   "
106190|NCT01667224|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related~     death each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity~     agent. However, the efficacy and safety of Actiponin supplementation on body weight~     regulation in humans are lacking.~   "
106191|NCT01667211|"~     Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis~     cervical cancer, to evaluate the efficacy and toxic reaction.~   "
106192|NCT01667198|"~     Professional societies recommend that endoscopists measure their ceacal intubation rate,~     adenoma detection rate as indicators of the screening colonoscopy quality. However, it is~     uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability~     in the detection of adenomas. The investigators hypothesize that a hands-on-training~     intervention tailored to the results of environmental assessment and audit on colonoscopy~     quality indicators results in higher adenoma detection rate improvement than simple audit~     and feedback. The investigators further hypothesize that by training the leaders of the~     screening centres, the effect of the intervention will be further disseminated among other~     endoscopists from the participating centers, and will thus result in additional increase in~     individual adenoma detection rate.~      The primary aim is to compare the impact on adenoma detection rate of two screening~     colonoscopy improvement programs:~        1. Tailored training intervention.~        2. Audit feedback on colonoscopy quality indicators.~   "
106227|NCT01666743|"~     The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in~     elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic~     therapy in the hospital.~   "
106193|NCT01667185|"~     The primary objective of the study is to evaluate the safety and effectiveness of the G4~     System (System) when used as an adjuvant to blood glucose testing over a 7-day period in~     pediatric subjects with diabetes mellitus.~      System effectiveness will be primarily evaluated with comparison to laboratory reference~     Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be~     evaluated in terms of point and rate accuracy of the system in reference to YSI. The point~     accuracy is measured as the proportion of G4 System values that are within ±20% of YSI~     reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.~     The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,~     will be evaluated as well as the temporal accuracy at different glucose rates of changes and~     different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary~     matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.~     System effectiveness will also be evaluated with SMBG measurements similarly.~      Safety data of the system will also be collected and safety will be characterized by the~     incidence of Adverse Device Effects (ADE) experienced by study participants.~      Other objectives include the evaluation of device performance at an alternate site (the~     upper buttocks).~   "
106194|NCT01667172|"~     Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive~     Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and~     adults.~      Research questions:~        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP~          values measured at the clinical laboratory?~        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?~          2.1.1. Comparison of 2 measurements in the same patient on 1 device~          (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on~          2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices~          equally userfriendly in a general practice surgery? (userfriendliness~   "
106195|NCT01667159|"~     This study will examine the effectiveness of an integrated treatment for adolescents who are~     depressed and use alcohol in an intensive outpatient setting in the community.~   "
106196|NCT01667146|"~     Some people develop the condition called acute respiratory distress syndrome (ARDS). This is~     a condition where the lungs have become injured from one of a number of various causes, and~     do not work as they normally do to provide oxygen and remove carbon dioxide from the body.~     This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS~     are admitted to the intensive care unit (ICU) and need help with their breathing by being~     connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of~     the body causing other problems but also death.~      Over the past few years, reducing the size of each breath delivered by the ventilator in~     conjunction with the use of an occasional sustained deep breath called a recruitment~     manoeuvre have been used to try to prevent further damage to the lungs in people with ARDS.~     This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research~     study to have some beneficial effects without causing any obvious harm, when compared to a~     current best practice ventilator strategy. The main beneficial effects of the PHARLAP~     strategy were to increase the amount of oxygen in the blood and to reduce markers of~     inflammation (the body reacting to a disease process) in the body. This study was too small~     to make a strong conclusion, so this study will be much larger and will assess whether~     patients who have developed ARDS are better off when we use the PHARLAP strategy. Three~     hundred and forty patients will be enrolled into this study in multiple ICUs across~     Australia and New Zealand.~      The study hypothesis is that the PHARLAP strategy group will have a higher number of~     ventilator free days at day 28 than the control group.~   "
106197|NCT01667133|"~     The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese~     patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or~     nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine~     kinase inhibitors (TKIs).~   "
106198|NCT01667120|"~     The general purpose of this study is to characterize the safety profile of ketorolac in~     infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective~     in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg~     intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%~     normal saline as placebo.~      Primary: The primary purpose of this study is to compare bleeding events in neonates who~     receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that~     ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.~      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine~     output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,~     amount of narcotic administered, blood pressure, and reintubation events on all patients in~     this study as secondary study points.~   "
106199|NCT01667107|"~     This single site study will examine plasma and alveolar compartment (AC) levels of~     posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant~     recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal~     infection rates will be assessed following transplantation.~   "
106200|NCT01667094|"~     Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of~     secretions, especially in the lungs. By adulthood, the majority of patients with CF will~     have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung~     infections. This usually results in worsening respiratory symptoms and often an acute~     deterioration in their lung function. They are usually treated with antibiotics that target~     the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous~     infusions several times a day. This study aims to compare the standard method of giving~     these antibiotics with a different strategy of giving these antibiotics to see if this can~     improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas~     aeruginosa in the lungs of these patients. This strategy consists of giving the same~     antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and~     the lung to be able to kill the bacteria.~   "
106230|NCT01666704|"~     The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic~     plaque inflammation~   "
106231|NCT01666691|"~     The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for~     certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly~     subcutaneous injections for 12 weeks.~   "
106201|NCT01667081|"~     This is a three-year (except for participants with chronic kidney disease [CKD] or~     cirrhosis) multicenter study to follow participants who received at least one dose of~     grazoprevir (MK-5172) in a previous study to determine whether they remain hepatitis C virus~     (HCV)-RNA negative over time, and to determine if they have developed antiviral resistance.~     The study will also evaluate long-term adverse events in this population. Participants from~     MK-5172-052 (NCT02092350) with CKD or cirrhosis will be followed for five years.~      As of Amendment 03, the study design is revised such that continued enrollment will only be~     for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD~     enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior~     treatment-response and remain in this study for five years, while participants enrolled from~     all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be~     discontinued and end their participation after the next scheduled visit. In addition,~     participants who receive other HCV treatments concurrent with this follow-up study or~     received other HCV treatments prior to this study will be discontinued and their data~     excluded from analysis.~   "
106202|NCT01667068|"~     Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is~     rising. Different cohorts are observing an increased risk for cardiovascular diseases in~     this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are~     more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection~     and metabolic disorders also caused by some antiretroviral substances as special~     non-traditional risk factors in HIV-infected persons can influence the development of~     cardiovascular diseases additionally. Therefore new research focus in special risk profile~     associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected~     patients is developing.~      This present study is an ongoing prospective regional multicenter trial that was conducted~     to analyse the incidence, prevalence and clinical course of cardiovacular disorders in~     HIV-infected out-patients.~      Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion,~     pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial~     endocarditis and heart valve disorders. In addition to previously stated disorders of the~     heart, the premature atherosclerosis of coronary arteries, a further even more important~     disease of the heart in this patient population, went into the focus of most HIV-researchers~     and physicians.~   "
106203|NCT01667055|"~     The true prevalence of drug allergy in patients with a history of penicillin/aminopenicillin~     allergy will be determined by using commercially available standard skin test reagents and~     the diagnostic agents available in Thailand. We hypothesize that only minority of patients~     with such a history are truly allergic.~   "
106204|NCT01667042|"~     This is a mechanistic research study to evaluate the relationship between cough, reflux, and~     aspiration in patients with systemic sclerosis (scleroderma).~   "
106205|NCT01667029|"~     The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid~     arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this~     study, the investigators will evaluate whether sulfasalazine improves pain due to painful~     peripheral neuropathy.~   "
106206|NCT01667016|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
106207|NCT01667003|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
106208|NCT01666990|"~     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually~     leads to clinically significant immunodeficiency. A chronic generalized immune activation is~     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1~     immunity and disease progression during chronic HIV-1 infection. However, it is still~     unknown whether reducing immune activation will restore CD4 T cell counts and leading to~     immune reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has~     been demonstrated to decrease immune activation of the host, and can suppress inflammation~     in human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune~     over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune~     reconstitution in HIV-infected immune non-responders.~   "
106209|NCT01666977|"~     The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug~     measuring progression free survival.~   "
106210|NCT01666964|"~     We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This~     will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can~     have life-saving ramifications and enhance quality of life and rehabilitation efforts in our~     combat veterans.~   "
106211|NCT01666951|"~     The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets~     administered once-daily compared to Prograf capsules administered twice-daily after kidney~     transplantation.~   "
106212|NCT01666938|"~     The purpose of this study is to investigate the effects of phone counselling support as a~     strategy to increase physical activity in people with diabetes.~   "
106213|NCT01666925|"~     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials~     become more widely available. However, transmission still persists and it appears that~     additional control measures are required. The leading malaria vaccine candidate in~     development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the~     field. This partial protection might be enhanced by combination with other components. The~     other vaccination approach that has produced repeatable efficacy in humans is the use of~     viral vectors to induce T cell responses. Previous attempts with this vaccine approach have~     been effective in challenge studies in Oxford, but ineffective in the field, probably~     because of reduced immunogenicity.~      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity~     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified~     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with~     thrombospondin- related adhesion protein (ME-TRAP).~      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and~     partial protection in 5 out of 14 volunteers in challenge studies.~      The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The~     investigators will assess the efficacy and further evaluate the immunogenicity and safety~     profile of the vaccine regimen. The investigators also intend to assess the correlates of~     efficacy and natural immunity.~   "
106216|NCT01666886|"~     In the protocol Predicting therapeutic outcome of mandibular advancement device treatment~     in obstructive sleep apnea (PROMAD), 100 patients with obstructive sleep apnea are included~     and started MAD treatment at 75% of maximal protrusion. All patients underwent~     polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep~     apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a~     reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy~     needs to be adjusted. Finding the most effective protrusion should be a weighted compromise~     between efficacy and side-effects of MAD therapy.~      In patients with insufficient results on the polysomnography with the MAD at 75% of maximal~     protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at~     the follow-up visit after the polysomnography with the MAD. After habituation and adaptation~     period but within 2 months after the first polysomnography with MAD, a new polysomnography~     will be performed to assess the effect of the 90% protruded position.~   "
106217|NCT01666873|"~     Evaluation of the clinical results after total knee prosthesis, and correlation with the~     alignment of the lower limb.~      Radiological measurements by means of 3D technology will be performed. The clinical result~     will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee~     score-questionnaire).~   "
106218|NCT01666860|"~     During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior~     Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of~     the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed~     and replaced by a bone graft. These patients form the population of this study. The goal of~     this study is to evaluate their current medical condition and to determine the clinical~     outcome.~      The clinical result will be stipulated by means of standardized questionnaires (VAS-score,~     Oswestry low Back Pain Questionnaire and SF-36)~   "
106219|NCT01666847|"~     Milking the umbilical cord from the placental end toward the infant has been shown to~     benefit preterm infants when compared to either clamping the umbilical cord immediately or~     waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has~     been shown to improve heart and lung function, reduces the need for blood transfusion, and~     reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of~     the umbilical cord, however in extremely premature infants is not considered safe, since it~     also delays the resuscitation that these infants need immediately after birth. Milking the~     umbilical cord is believed have similar benefits to delaying the clamping of the cord, but~     can be done much faster (seconds rather than minutes). In this study, the cord will milked~     three times over about 10-20 seconds and the infant will be passed to the awaiting newborn~     medical team for routine care. Participants of this study will be randomly assigned to one~     of two study groups: the first group will have the cord milking intervention and the second~     group will not have any intervention other than routine, immediate cord clamping with~     routine care of mother and infant. Data will be collected about the mother prior to delivery~     and data will also be collected about the baby using computerized health records. The data~     will look at short term changes in red blood cell volumes, the need for blood transfusions,~     and rates of known complications of prematurity, including longer term developmental~     complications at 18-24 months.~      The hypothesis is that milking the umbilical cord before cutting the cord will lead to a~     higher hemoglobin concentration and decrease the need for blood transfusions in extremely~     preterm neonates compared to the current standard of immediately clamping the umbilical~     cord.~   "
106220|NCT01666834|"~     The characteristics and outcomes of a mixed group of critically ill patients who received~     mechanical ventilation are not known in China.~      A 1 month Cross-section survey will be performed with the aim of describing the~     characteristics and outcomes of conventional mechanical ventilation and treatment of acute~     respiratory distress syndrome in intensive care units in China.~   "
106221|NCT01666821|"~     To investigate pathomorphological and functional variations of choroidal neovascularization~     (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical~     coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative~     AMD.~   "
106222|NCT01666808|"~     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases~     diagnosed per year. Several different local therapies are available for treatment, including~     surgery and radiotherapy Significant advances have been made in the technical aspects of~     surgery and of radiotherapy which have improved both the cancer control outcomes as well as~     the morbidity of treatment. Despite these significant advances, approximately 30% of~     patients treated with definitive local therapy experience recurrent disease. Recurrent~     disease after prostatectomy usually manifests with rising PSA (blood test for prostate~     cancer). The PSA level is often of limited use in differentiating local recurrence (ie.~     recurrence in the prostate bed) from recurrence outside of the prostate bed (~     extra-prostatic recurrence).~      One PET radiotracer which has shown promise in the staging and restaging of patients with~     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid~     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher~     accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with~     suspected recurrent prostate carcinoma.~      The major goal in this proposed investigation is to use advanced molecular imaging to better~     guide post-prostatectomy decision making, in terms of guiding the decision to deliver~     radiotherapy, and in terms of the exact areas treated with radiotherapy.~      Investigators will perform a study with 162 patients in whom there is a strong suspicion of~     prostate cancer that has returned to the body after having a prostatectomy. Half of these~     patients will have radiotherapy decision-making and delivery per the usual routine, and half~     of these patients will have the radiotherapy decision and volumes guided by the FACBC test.~     The major goal of the investigation is to see whether the FACBC improves the selection and~     the cancer control rates of post-surgery patients with a rising PSA who undergo~     radiotherapy.~   "
106223|NCT01666795|"~     The objective of this human study was to evaluate the association between the specificity of~     anti-platelet autoantibodies and response to IVIG treatment.~   "
106224|NCT01666782|"~     The safety and immunogenicity of high dose influenza vaccine has not been studied in young~     patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and~     safety of high dose influenza to standard dose influenza vaccine in adult oncology patients~     who are younger than 65 years old receiving chemotherapy.~   "
106225|NCT01666769|"~     Determine proper dosing of micafungin in children supported with extracorporeal membrane~     oxygenation (ECMO).~   "
106226|NCT01666756|"~     This phase I trial studies the side effects and best dose of Chinese herbal formulation~     PHY906 when given together with sorafenib tosylate in treating patients with advanced liver~     cancer. Biological therapies, such as Chinese herbal formulation PHY906, may interfere with~     the growth of tumor cells and slow the growth of tumors. Sorafenib tosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib~     tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor.~     Giving Chinese herbal formulation PHY906 together with sorafenib tosylate may work better in~     treating advanced liver cancer.~   "
106233|NCT01666665|"~     Massive pediatric burns are associated with a persistent and sustained hypermetabolic~     response characterized by elevated levels of circulating catecholamine's, cortisol, and~     glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound~     healing. Insulin and metformin have demonstrated anabolic activity with minimal associated~     side effects. However, it is unknown whether the beneficial effects arise from tight~     euglycemic control or direct effect of insulin action. We hypothesize that during acute~     hospitalization, administration of metformin at a dose titrated to maintain blood glucose~     between 80-180 mg/dl will accelerate wound healing and recovery in children with severe~     thermal injury and will have beneficial long-term effects on muscle strength, immune~     function, and wound healing.~   "
106234|NCT01666652|"~     The study is designed to afford a first time in humans (FTiH) safety and immunogenicity~     assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine~     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or~     AS03B (adjuvants used in Glaxo Smith Kline (GSK) Biologicals' hepatitis B candidate vaccine,~     malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate~     will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally,~     the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of~     purified virus antigen per each of the four DENV types. The control group will receive a~     saline placebo. All experimental vaccinations will be administered according to a 2-dose~     schedule, 28 days apart.~   "
106235|NCT01666639|"~     Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain~     has proven its short-term effectiveness. Exercise therapy plays a major role in such a~     combination of treatments. There is a considerable need to develop theory-based exercise~     interventions which foster a long-term adherence to physical activity. Furthermore, an~     integration of behavioral elements such as coping competencies regarding back pain is~     needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes~     its effects. The role of exercise therapy has yet to be investigated. Aim of this study is~     the implementation of a standardized behavioral exercise therapy into an existing~     behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis~     is that the participation in the behavioral exercise therapy leads to greater short- and~     long-term improvements in functional capacity compared to the usual care.~   "
106236|NCT01666626|"~     The purpose of this study is to determine whether ultrasound-based assessment of intestinal~     stiffness in patients with Crohn's disease predicts the effectiveness of medical therapy or~     the need for surgical resection.~   "
106237|NCT01666613|"~     The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is~     administered in different ways - orally, intravenously or inhaled (with two different~     devices), to healthy subjects~   "
106238|NCT01666600|"~     Patients with glioblastoma at first or second progression who have failed standard treatment~     that must have included radiochemotherapy with temozolomide and who are a candidate for a~     reirradiation can be included into the trial. In the phase I part the minimal tolerated dose~     (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase~     II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.~   "
106239|NCT01666587|"~     The purposes of this study are two-fold. The first purpose is to determine the effect of~     taking vitamins on the recovery of an artery (blood vessel) following an induced temporary~     injury. The second purpose is to determine whether a specific vasodilator is less abundant~     after the injury and whether this contributes to increased constriction or after the injury.~     Finally, does vitamin consumption have an effect on the recovery from the injury if one of~     the substances in the blood that causes vessels to enlarge (dilate) is stopped?~   "
106240|NCT01666574|"~     This study is to determine if two breakfasts of equivalent calories, an oat based breakfast~     cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also~     determine if the two calorically equivalent oat-based breakfast cereals give different~     caloric intakes at a lunch meal that participants will eat to their satisfaction.~   "
106241|NCT01666561|"~     To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an~     equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety~     over the 4 hour period following breakfast.~   "
106242|NCT01666548|"~     The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial~     outcome of haemolytic uraemic syndrome in childhood.~      The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in~     childhood. The more common typical HUS is mostly caused by Shigatoxin-producing~     enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by~     different genetic abnormalities in complement regulatory proteins.~      About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and~     require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate~     increased during the last years. Despite this, there are only few data concerning long-term~     prognosis, cognitive and motoric development, as well as psychological coping and~     health-related quality of life of affected children and their parents.~   "
106243|NCT01666535|"~     The investigators will compare the immunogenicity of influenza vaccine in adults and~     children with inflammatory bowel disease by timing of vaccine in relation to maintenance~     infliximab dosing. The primary objective is to compare the proportion of IBD patients on~     maintenance infliximab who mount serologic protection to each component of the influenza~     vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and~     patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic~     protection will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary~     objective is to compare the proportion of IBD patients who mount an immunogenic response (≥~     4-fold increase from pre to post-vaccination titer) to each component of the influenza~     vaccination between patients vaccinated on day of infliximab infusion and those vaccinated~     at the mid-point.~   "
106255|NCT01666379|"~     The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo~     both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and~     paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus~     surgery.~   "
109367|NCT01624727|"~     The purpose of the study is to target inflammation to reduce progression of noncalcified~     plaque in the coronary arteries using an intensive lifestyle intervention with omega-3 fatty~     acid supplementation compared to standard of care.~   "
106244|NCT01666522|"~     In the present study the aim was to determine the prevalence of sarcopenia and to evaluate~     the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle~     mass and strength in community-dwelling older adults with osteopenia /osteoporosis.~      One hundred and forty-five individuals aged 65 years and above with documented~     osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned~     to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D~     (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute~     3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day~     and the control group was provided with health education using videotaped presentations,~     physician talks on topics concerning bone and muscle health. Body composition was measured~     DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity~     Questionnaire. Physical performance was assessed using upper limb grip strength, walking~     speed and knee extension strength. All data was collected at baseline and at 4 months.~   "
106245|NCT01666509|"~     Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one~     such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.~     Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage~     1 is poorly understood and treatment options are limited and therefore this study - within~     the target indication - will contribute to the learning about rosacea.~   "
106246|NCT01666496|"~     The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy~     of an interactive video game the investigators are developing at reducing risk behaviors in~     at-risk teens.~   "
106247|NCT01666483|"~     A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34~     were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to~     undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS~     and LESS.~   "
106248|NCT01666470|"~     Quality of life of patients with a history of drug allergy in Thailand will be studied.~   "
106249|NCT01666457|"~     The specific aim of this pre-post trial is to compare data regarding oral feeding, length of~     stay, and growth outcomes of 100 NICU infants to these same outcomes following the~     implementation of a developmentally supportive, infant driven feeding program with the NICU~     staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding~     program on a second sample of 100 NICU infants at Children's Memorial Hospital.~      The specific research questions considered in this study are:~        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically~          fragile infants in the NICU at discharge and at 3 months post-term?~        2. What is the impact of implementing the SOFFI on the growth outcomes of medically~          fragile infants in the NICU at discharge and at 3 months post-term?~        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile~          infants in the NICU?~        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU~          staff evaluations and communications related to managing oral feedings with medically~          fragile infants?~   "
106250|NCT01666444|"~     The purpose of this study is to compare the overall survival of patients treated with~     VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in~     women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal~     cancer.~      VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple~     components of the innate immune system and is being developed as a novel therapeutic agent~     for use in oncology. Experimental data obtained in an animal model of ovarian cancer~     supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337~     and PLD resulted in a significant reduction in tumor growth compared to either agent alone~     and an increase in the number of T lymphocytes infiltrating the tumor. The combination of~     PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase~     1b study and appears to be generally well-tolerated.~   "
106251|NCT01666431|"~     Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high~     frequency of EGF-R expression. EGFR is an important regulator of tumour progression and~     proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR~     and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to~     inhibition of cell proliferation and induction of apoptosis. Based on the data from~     oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its~     interactions play an important role in the SCC pathogenesis and represent a good therapeutic~     target from these tumours.~      Primary Objectives:~      To evaluate the tumour response macroscopically in patients with primary cutaneous SCC~     lesions and in concomitant SCC in situ (AK).~      Secondary Objectives:~        -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in~          patients with SCC as measured by time to first AE or SAE within the study period.~        -  To investigate the molecular tumour response of squamous cell carcinoma lesions in~          patients under lapatinib treatment using a set of variables.~        -  Trial with medicinal product~   "
106252|NCT01666418|"~     This is an open, monocentric, pilot study to determine the metabolic activity~     (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination~     therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of~     cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus~     paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not~     received prior cytotoxic chemotherapy.~      Primary Objective:~      Evaluation of metabolic activity in vivo~      Secondary Objective:~      Determination of changes in gene expression profiling Evaluation of the antitumor activity~     of the combination in terms of progression free survival (PFS). Changes in S100 and LDH~     during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100~     and LDH)~        -  Trial with medicinal product~   "
106253|NCT01666405|"~     The purpose of this study is to determine the effectiveness of percutaneous tibial nerve~     stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc.,~     Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).~   "
106254|NCT01666392|"~     The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation~     has an impact on inflammation and lean body mass in older adults. The investigators expect~     that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass~     compared to placebo.~   "
106256|NCT01666366|"~     Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to~     the left coronary system in terms of patency and survival benefit. Several BITA~     configurations are proposed for left-sided myocardial revascularization, but the ideal BITA~     assemblage is still unidentified.~      From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our~     institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were~     randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration~     (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3~     and 7 years . Patient telephone interviews were conducted every 3 months and a stress test~     performed twice yearly under the referring cardiologist's supervision. Angiographic~     follow-up was performed 6 months after surgery. The primary and secondary end points were,~     respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA~     grafts that were completely occluded at follow-up angiography.~   "
106257|NCT01666353|"~     This study aims to develop methods for quantitative imaging of solid tumors in patients who~     are receiving immunotherapies that have a delayed mechanism of action.~      PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and~     is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET~     is now used commonly in detecting melanoma in humans as melanomas quite consistently have~     high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has~     not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been~     shown to be highly predictive of outcomes of patients following radioimmunotherapy of~     lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy~     initiation.~      In order to develop PET/CT as a tool to detect early evidence of response in patients with~     solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT~     imaging prior to therapy, again between days 21 and 28, and finally at 4 months~     post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.~     Investigators will use the PERCIST criteria to determine peak and maximum standardized~     uptake values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total~     glycolytic volumes, and will use CT from PET/CT to measure tumor size by immune RECIST~     criteria. (See section on Outcome Evaluation below.) Investigators will assess whether early~     changes in tumor metabolism seen on FDG PET are predictive of progression free and overall~     survival outcomes. Through these systematic pilot studies, investigators hope to better link~     FDG PET measurements to individual patient responses to immune checkpoint blockade therapy~     and better understand and refine this emerging and often effective therapeutic approach.~   "
106258|NCT01666340|"~     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The~     extent of reduction will be intensity dependent.~   "
106259|NCT01666327|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel~     disease.~   "
106260|NCT01666314|"~     This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the~     pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly~     with prednisone in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer~   "
106261|NCT01666301|"~     Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing~     the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration~     interval decreases hemoglobin variability. The benefit of reducing the administration~     interval was however lessened by the variability induced by more frequent dosage~     adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin~     kinetics under different ESAs and administration intervals in a collective of chronic~     hemodialysis patients.~      Methods: The study was designed as an open-label, randomized, four-period cross-over~     investigation, including 30 patients under chronic hemodialysis at the regional hospital of~     Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies~     (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were~     compared with each other. The mean square successive difference of hemoglobin, reticulocyte~     count and ESAs dose was used to quantify variability. We distinguished a short- and a~     long-term variability based respectively on the weekly and monthly successive difference.~   "
106262|NCT01666288|"~     Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often~     difficult to diagnose due to the wide heterogeneity of clinical manifestations. The inciting~     agent is often difficult to pinpoint and may include food, environmental allergens in~     patients undergoing allergen immunotherapy, insect stings, and medications. Evidence of~     allergy by demonstration of a positive skin test to the inciting agent, is helpful only if~     skin testing is available. The only diagnostic modality that is useful in the diagnosis of~     anaphylaxis when IgE skin testing is not available and the inciting agent is unknown, is an~     elevated serum tryptase level. However, a diagnosis of anaphylaxis can be made without a~     tryptase level or if the tryptase level is normal. A simple, non-invasive test for patients~     with anaphylaxis is not currently available and would be helpful to diagnose and to guide~     further management options.~      Patients who develop anaphylaxis to environmental allergens or venoms during routine~     outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as~     we are able to evaluate these specific reactions in a controlled, clinical environment.~     Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and~     4 percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a~     well established form of therapy for patients with allergic rhinitis, allergic asthma, or a~     confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this~     group of patients during a reaction and at baseline one week after a reaction, thereby~     allowing each patient to serve as his or her own biological control.~      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which~     result from the regulatory response to physiological stressors, disease processes, drug~     therapy, or allergen or venom immunotherapy. By measuring changes in metabolite~     concentrations, the range of biochemical effects and therapeutic intervention can be~     determined.~      The investigator plans to use metabolic profiling of blood samples collected at the time of~     anaphylaxis and one week after, to see if a simple, non-invasive test for patients with~     anaphylaxis could be developed.~   "
106263|NCT01666275|"~     Metabolomics is the study of metabolic pathways and the unique biochemical molecules which~     result from the regulatory response to physiological stressors, disease processes, or drug~     therapy. By measuring changes in metabolite concentrations, the range of biochemical effects~     and therapeutic intervention can be determined.~      Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease~     characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to~     aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin~     during challenge/desensitization is equivalent to an allergic drug reaction however we are~     able to evaluate these specific reactions in a controlled, clinical environment. This~     population of patients undergoing aspirin desensitization is ideal for studying metabolomics~     as serial blood sampling can be performed in patients before, during a reaction, and after~     aspirin desensitization, thereby allowing each patient to serve as his or her own biological~     control. The investigator hopes that this study of metabolomics will allow for better~     methods of identifying anaphylaxis in the future.~   "
106264|NCT01666262|"~     The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live~     Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral~     immune response of the above vaccine after intranasal application by using HAI test, micro~     neutralization assays.~   "
106265|NCT01666249|"~     The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific~     antibodies against factor D and neutralizes D antigen present in the Rh-positive fetal red~     blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).~     This a immunization study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in~     Rh and Coombs negative women with risk sensitization.~   "
106266|NCT01666236|"~     Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary~     to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area~     after twelve months, compared to baseline. Treatment under study is a triple therapy with:~     1) reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3)~     IVT ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED)~     secondary to Polypoidal Choroidal Vasculopathy (PCV).~   "
106267|NCT01666223|"~     The purpose of this study is to describe the physiological, pathophysiological and~     potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1)~     secretion in human glucose homeostasis.~   "
106268|NCT01666210|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation~     and pain in subjects who have undergone cataract extraction with intra-ocular lens~     implantation.~   "
106269|NCT01666197|"~     The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet~     compared with placebo taken three times a day in subjects with acute ankle sprains under~     'in-use' conditions, in particular with regard to pain relief.~   "
106270|NCT01666184|"~     Study Design:~      Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for~     pancreatic cancer; (3) willing to sign informed consent.~      The pancreatic tumor, tissue specimen and blood sample before or after treatment will be~     collected from department of pathology, surgery or diagnostic medicine.~   "
106271|NCT01666171|"~     RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women~     with early-stage breast cancer may help plan treatment.~      PURPOSE: This trial studies changes in breast density in patients with early-stage breast~     cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.~   "
106272|NCT01666158|"~     Consenting patients scheduled for esophageal resection surgery will be randomized to receive~     standard nutrition counseling (including nutritional supplements as needed) or standard~     nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.~      It is hypothesized that, compared with the group receiving nutrition alone, the addition of~     physical exercise to nutrition starting before surgery and continuing for 8 weeks after~     surgery will have a significantly greater impact on functional walking capacity during the~     prehabilitation period and during the postoperative period, and on the incidence of~     postoperative pulmonary complications.~   "
106273|NCT01666145|"~     Advanced Image Guidance for this study was used during laparoscopic microwave ablation~     surgery to help the surgeon accurately place the ablation needle into the tumor of patients~     diagnosed with liver cancer.~   "
106274|NCT01666132|"~     Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients~     with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine~     whether the administration of the cells improves recovery of the left ventricular function.~     Secondary objective is the finding of clinical or paraclinical parameters to predict~     potential benefits of the treatment (basing on MRI characteristics such as size,~     transmurality of the myocardial infarction and peri-lesional ischemia).~      In the first part of the study 10 patients are treated without control group. This phase~     serves as feasibility and safety part of the study.~   "
106275|NCT01666119|"~     This is an open label study in opioid dependent subjects maintained on a stabilized dose of~     Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA~     Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects~     stabilized on Suboxone (buprenorphine/naloxone) tablets or films.~      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.~     This dose will be taken throughout the 12-week treatment period with dose adjustments as~     clinically indicated for either the control of opioid dependence or adverse events (AEs).~   "
106276|NCT01666106|"~     Osteonecrosis of the Jaw (ONJ) Case Registry~   "
106277|NCT01666093|"~     Background: Lower limb arterial revascularization procedures, either percutaneously or~     surgically performed, are an established treatment modality of ischemic foot ulcers,~     especially in the setting of a critical limb ischemia. Many other lower limb ulcers are~     secondary to a combined disease, which may include a concomitant venous disease (chronic~     venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel~     disease). In this setting, and especially in the absence of a concomitant severe~     macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb~     revascularization have so far never been evaluated in a prospective study.~      Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular~     revascularization approach of the lower limb, in all consecutive patients presenting with a~     non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e.~     mixed-origin ulcers).~      Material and methods: This prospective study will consecutively include all patients~     presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer~     co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous~     disease, infectious disease or inflammatory disorder must be previously evaluated and~     adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ±~     systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be~     obtained in all patients. The arterial screening must included an ankle-brachial index (ABI)~     and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot~     and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This~     arterial work-up must be compatible with the presence of a mild to moderate peripheral~     artery disease without any sign or criteria suggesting the presence of a critical limb~     ischemia.~      End-points: The success rate of perform an endovascular revascularization intervention in~     all consecutive patients which qualify according to the inclusion criteria (technical~     feasibility). Establish the proportion of procedural related complications (safety). Analyze~     the clinical and the para-clinical improvements in term of heal of the ulcers, as well as~     the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure~     (efficacy).~      Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of~     enrollment the investigators will perform an interim analysis and will decide at that~     moment, according to the observed end-points, if prolonging the study would be of any~     scientific value or if the study has to be interrupt earlier because of a significant~     improvement of all already treated ulcers.~   "
106278|NCT01666080|"~     This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell~     transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with~     non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and~     low dose total body irradiation (TBI), is designed to promote engraftment in patients who~     failed to achieve an acceptable level of donor-derived engraftment following a previous~     allogeneic HCT.~   "
106279|NCT01666067|"~     The investigators hypothesize that vytorin will improve insulin resistance compared with~     simvastatin~   "
106280|NCT01666054|"~     The study hypothesis is that reducing patient-ventilator asynchrony will reduce time~     required to wean from mechanical ventilation. The purpose of this pilot study is (1) to~     assess study feasibility in terms of recruitment, protocol adherence and efficacy of the~     intervention for reducing asynchrony, (2) to assess baseline rates of asynchrony and~     outcomes in the control arm in order to perform sample size calculations, if needed, for~     further, larger studies designed to detect differences in weaning time in specific,~     predefined populations and (3) to examine how often ineffective triggering (and therefore~     reduced ventilator respiratory rate) at higher levels of pressure support lead to a false~     conclusion that higher levels of support are needed to diminish respiratory distress.~   "
106281|NCT01666041|"~     The investigators hypothesize that fenofibrate/omega will improve insulin resistance~     compared with fenofibrate~   "
106282|NCT01666028|"~     The main objective of this study is to determine the feasibility, efficacy and safety of~     automated closed-loop glucose control in the home setting over a short term period. The data~     and experienced gained from this study will be utilised in planning future home studies.~      This is an open-label, three centre, randomised, crossover design, involving two, 8 day~     (first day in the clinical research facility and seven days at home) study periods during~     which glucose levels will be controlled either by an automated closed-loop system or by~     subjects usual insulin pump therapy in random order. A total of up to 24 adults (aiming for~     18 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be~     recruited through diabetes clinics and other established methods in participating centres.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. During the 24 hour in-patient stay subjects will be encouraged to mimic their usual~     day and will be allowed to walk inside hospital premises. Subjects will be advised to~     discontinue automated closed-loop insulin delivery and follow their usual insulin pump~     therapy for periods of strenuous exercise during the 7 day home study phase.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the~     time spent with glucose levels above and below target, as recorded by CGM, and other~     CGM-based metrics, and for the stay at the clinical research facility, time spent in the~     target range, above and below the target range as measured by plasma glucose.~   "
106283|NCT01666015|"~     Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship~     and cure various oncologic diseases. However, this therapy is associated with high mortality~     rates and numerous negative side-effects. The recovery of the immune system is a special~     concern and plays a key role in the success of this treatment. In healthy populations it is~     known that exercise plays an important role in immune system regulation, but little is known~     about the role of exercise in the hematological and immunological recovery of children~     undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized~     Controlled Trial is: study the effect of an exercise program on immune cell recovery in~     patients undergoing autologous stem cell transplantation. The Secondary objective is to~     determine if an exercise intervention might diminish the deterioration of quality of life,~     physical fitness, and the acquisition of a sedentary lifestyle.~      Methods~      Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to~     18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or~     control group. The exercise group will participate in a two-phase exercise intervention (in~     and outpatient) from hospitalization until 10 weeks after discharge. The exercise program~     includes strength, flexibility and aerobic exercise. During the inpatient phase this program~     will be performed 5 times/week and will be supervised. The outpatient phase will combine a~     supervised session with two home-based exercise sessions with the use of the Wii device. The~     control group will follow the standard protocol without any specific exercise program. A~     range of outcomes, including quantitative and functional recovery of immune system, cytokine~     levels in serum, NK cells and their subset recovery and function, and gene expression of~     activating and inhibitory NK cell receptors, body composition, nutrition, quality of life,~     fatigue, health-related fitness assessment and physical activity levels will be examined,~     providing the most comprehensive assessment to date.~      Discussion We expect to find an improvement in the immunological recovery, quality of life,~     decreased acquisition of sedentary behavior and less fitness deconditioning.~   "
106284|NCT01666002|"~     The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond~     pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will~     compare the success rates of those receiving laser treatments with untreated patients. This~     study will provide a clinical basis for determining the relative effectiveness of an~     increasingly utilized treatment method.~   "
106285|NCT01665989|"~     This research project has two primary specific aims in the Partners HealthCare clinical~     population and setting:~        1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle~          behavioral intervention program with usual care (UC) (brief nutrition counseling and~          referral to Nutrition Services, the current standard), on the primary outcome of weight~          loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and~          prescription medication (doses and costs) for diabetes and its related conditions.~           We hypothesize that participants who receive the translation of the Look AHEAD program~          will lose significantly more weight and have lower glycemia, blood pressure,~          cholesterol, and drug doses and costs for these conditions than participants who~          receive UC.~        2. To compare the effects of the two interventions on health behaviors, self-efficacy,~          diabetes-specific quality-of-life and patient satisfaction with quality of care.~      We hypothesize that participants who receive the translation of the Look AHEAD program will~     be more satisfied with their care and will experience greater improvements in health~     behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who~     receive UC.~      Secondary specific aim: To assess the cost-effectiveness of the two interventions and the~     potential cost savings in terms of reductions in medication doses. In the current~     environment, a cost effective approach to lifestyle change is imperative. The costs and~     benefits of the interventions in this project will be carefully analyzed.~   "
106286|NCT01665976|"~     This single center, randomized, single dose, open-label, four period cross-over study will~     evaluate the relative bioavailability of RO4917838 and the effect of food following oral~     administration in healthy volunteers. Subjects will receive in randomized order single oral~     doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838~     hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21~     days between treatments. Anticipated time on study will be up to 23 weeks.~   "
106287|NCT01665963|"~     Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of~     hematoma after device implantation. This study intends to examine the efficacy of the~     TopClosure(c) System in wound healing in these patients.~   "
106302|NCT01665768|"~     This research is being done to determine if combining an investigational drug called~     Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose~     chemotherapy.~   "
106288|NCT01665950|"~     Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an~     adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals~     with bipolar I disorder in a nonpsychotic major depressive episode.~      Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms~     assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).~   "
106289|NCT01665937|"~     STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is~     thought to play a role in tumor growth. By interfering with this protein's function,~     STA-9090 may help kill tumor cells. This drug has been used in other research studies and~     information from those studies suggests that this agent may help to slow tumor growth in~     HCC.~      The purpose of this research study is to find the highest dose of STA-9090 that can safely~     be given to participants with advanced HCC. The investigators will also get more information~     about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the~     body.~   "
106290|NCT01665924|"~     The purpose of the study is to evaluate the amount of compound present in the blood~     (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy~     subjects.~      During the course of the study, the effect of aging on the pharmacokinetics as well as the~     effects of GLPG0634 on mechanism of action-related parameters in the blood~     (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in~     elderly healthy subjects will be characterized.~   "
106291|NCT01665911|"~     The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind~     and will utilize a 5-way cross-over study design with a primary objective to determine if a~     higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary~     objectives are to determine in a higher concentration of fluoride in milk will provide a~     greater caries preventive effect and if the caries preventive effect of fluoridated milk~     follows a dose-response pattern.~   "
106292|NCT01665898|"~     Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon~     polyps.~   "
106293|NCT01665885|"~     HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy,~     tolerability, practicability and safety of endovascular versus surface cooling in awake~     stroke patients.~   "
106294|NCT01665872|"~     Phase II of the MOMS Partnership aims to:~        1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;~        2. provide on-site group intervention services (randomized by housing community) to~          improve signs/symptoms of depression/stress/trauma among mothers living onsite.~   "
106295|NCT01665859|"~     Umbilical and epigastric hernia repairs are common and performed by numerous surgical~     techniques. Considering that the hernia repairs in general are relatively small and simple~     procedures there are disproportionate poor results.~      The aim of present study is to determine surgical risk factors for readmission after~     umbilical and epigastric hernia repair and to report risk factors for later reoperation for~     recurrence.~   "
106296|NCT01665846|"~     The purpose of this study is to describe the radiologic findings on brain MRI after~     ferumoxytol administration in HIV-infected patients with cognitive impairment.~   "
106297|NCT01665833|"~     We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an~     independent predictor of recurrent or persistent angina following coronary~     revascularization. The SYNTAX score is a score that suggests the severity of coronary artery~     disease detected by coronary angiography. Coronary revascularization is a procedure that~     occurs in two ways, a percutaneous coronary intervention (PCI) and a coronary artery bypass~     graft (CABG) and is done when there is narrowing and blockage or hardening of the arteries~     (atherosclerosis) surrounding the heart. Narrowing and blockages reduce blood flow to parts~     of the heart causing chest pain (known as angina) and sometimes myocardial infarction.~   "
106298|NCT01665820|"~     Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more~     effective in identifying referrable murmurs than using a traditional stethoscope.~   "
106299|NCT01665807|"~     The investigators hypothesize that people working in an acute care hospital setting will be~     able to successfully self-administer the intradermal vaccine (Intanza) in less time than~     nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The~     investigators also hypothesize that people administering the intradermal vaccine for the~     second time will take less time to successfully administer than people administering it for~     the first time.~   "
106300|NCT01665794|"~     This phase I/II trial studies the safety and the best dose of carfilzomib and to see how~     well it works when given together with pomalidomide and dexamethasone in treating patients~     with relapsed or refractory multiple myeloma. Carfilzomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Pomalidomide may stimulate the~     immune system in different ways and stop cancer cells from growing. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib~     together with pomalidomide and dexamethasone may kill more cancer cells~   "
106301|NCT01665781|"~     Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore~     subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence~     of headache in an unacclimatized person who has recently arrived at an altitude above 2,500~     m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia,~     nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass~     is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO)~     secretion begins hours after ascent and stimulates bone marrow production of red blood~     cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is~     feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.~      In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM)~     reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal~     oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On~     the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude~     acclimatization.~      However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO~     therapy have been shown to decrease fatigue and increase work capacity and exercise~     tolerance. In addition, improvement in CNS function and cognitive ability has been noted~     with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to~     cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of~     which are symptoms associated with high altitude illness.~      The investigators also reported improved muscle energy metabolism with EPO in dialysis~     patients, but not with RBC transfusion.~      In this study, the investigators will conduct a randomised controlled trial to assess the~     effect of EPO administration on AMS at an altitude of 4,130 m.~   "
106303|NCT01665755|"~     In this study, we are comparing the difference in outcomes between patients who were given~     shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before~     CPR is started. The study population will be all cardiac arrest patients attended by the~     staff of the Emergency Department who fulfil the eligibility criteria. Patients will be~     managed according to currently approved cardiac arrest protocols. Patients confirmed in~     cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest~     compressions are delivered by an automated device) is prepared. Mechanical CPR should be~     started as soon as possible (<1 minute). If patients are eligible to be shocked, they will~     receive shocks either during upstroke of CPR or before CPR is started.~      Thus the purpose of this study is to answer the question whether are there improvement in~     survival between when shocks are given during upstroke and before CPR is started.~   "
106304|NCT01665742|"~     The number of overweight and obese children has increased in Ireland at a greater rate than~     worldwide trends. The poor eating patterns that drive adolescent obesity leads to an~     increase in the number of unhealthy inflammatory hormones and fats circulating in the blood~     which increase an adolescent's risk of developing diabetes and heart disease later in life.~     Dietary patterns have changed whereby key nutrients that are found in fruit, vegetables and~     fish, which are known to have beneficial effects and reduce risk of obesity and diabetes in~     later life, may need to be replaced. This project will determine whether a key~     anti-inflammatory nutrient supplement taken for 8 weeks will improve the metabolic profile~     of adolescents aged 13-18 years old. Detailed cellular analysis will determine the cellular~     and molecular mechanisms to provide a thorough explanation of the health effects of this~     intervention.~   "
106305|NCT01665729|"~     Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the~     early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent~     episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke~     according to the etiology and pathogenesis is important.~      The 2007 Korean modified TOAST type got some progress, but there exists two major~     disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction~     etiology; lack of typing according to the pathogenesis of large atherosclerotic infarction~     and taking measures of treatment according to the new types. Recently, domestic professor~     Gaoshan proposes new approach to diagnose and treat minor ischaemic stroke according to the~     etiology and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction~     with severe stenosis of large artery is unclear. Is it low perfusion? Or artery-artery~     embolization? Or both? How to distinguish the pathogenesis of branch artery disease: by~     atherosclerosis? Or hyalinosis? Or both? How to check the validity of clinical types? This~     study take different interventions according to different types and observation of the long~     term clinical results of intervention( mortality, recurrence rate, disability rate and rate~     of cerebral hemorrhage and subarachnoid hemorrhage), in order to clarify the new types can~     indeed solve the current problem of minor ischaemic stroke with high mortality, recurrence~     rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage.~   "
106306|NCT01665716|"~     In healthy women, early menopause is an event that is associated with the exacerbation of~     several risk factors of cardiovascular and skeletal disease. The occurrence of an early~     menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A~     small number of studies has demonstrated that DM-1 patients experience cycle irregularity~     and menopause at a younger age compared to controls. In addition, initial studies have~     suggested that also in regular cycling DM-1 women a decreased ovarian reserve status for age~     is present. The explanation for this early decay in ovarian reserve in DM-1 patients remains~     unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated~     ovarian ageing in DM-1 patients.~      Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of~     the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian~     ageing, with focus on vascular factors, may shed new light on our understanding of the~     ovarian ageing process per se.~   "
106307|NCT01665703|"~     This pilot study is designed to evaluate imaging parameters indicative of underlying tumor~     biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)~     who are planning to undergo nephrectomy will be identified, and recruited to undergo a~     contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography~     (MR-FDG-PET) scan.~   "
106308|NCT01665690|"~     The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community~     level randomized trial designed to test the hypothesis that a public health program designed~     to increase the use of expedited partner therapy can decrease the prevalence of chlamydial~     infection in young women and the incidence of gonorrhea in Washington state. The study~     intervention will be modeled after and intervention previously evaluated in King County WA~     (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion~     of patient delivered partner therapy (PDPT) use by medical providers in accordance with~     Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be~     promoted through education and by making medication packs for PDPT available statewide.~     Medical providers will refer selected persons with gonorrhea or chlamydial infection for~     partner services based on defined criteria associated with failure to ensure partners'~     treatment. The intervention will be instituted in four waves separated by 6-9 months. Each~     wave will include approximately 6 local health jurisdictions. The order in which health~     jurisdictions initiate the intervention will be randomly assigned. The study's primary~     endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through~     clinics participating in the state's Infertility Prevention Project (IPP) and the incidence~     of gonorrhea among women as determined through public health reporting.~   "
106318|NCT01665560|"~     The overarching goal of this project is to understand how nicotine addiction interacts with~     feeding behaviors and brain representation of food reward. The current proposal is part of a~     larger effort to begin a program of research to elucidate similarities and differences in~     perception of, and behavioral and neural response to, food and cigarette aromas as a~     function of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not~     gain weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation~     (acute, chronic). A general hypothesis is that there are overlapping neural mechanisms~     governing food reward and cigarette reward in smokers and that this overlap includes~     incentive salience encoding.~   "
106309|NCT01665677|"~     Hematopoietic stem cell transplantation is a procedure in which a person receives blood~     forming stem cells from a person called a donor. The stem cells can be obtained from the~     hollow part of the hip bone or from blood.~      A serious problem with this treatment is Graft Versus Host Disease (GVHD). This happens when~     stem cells from the donor attack normal cells of the recipient. Currently, there is no~     universal standard of care in the United STates to prevent GVHD.~      This study is being done to see if a medicine that is used to lower cholesterol can also~     help in reducing GVHD.~      Patients will receive atorvastatin daily by mouth starting 14 days before stem cell~     transplant. They will continue to take atorvastatin until 180 days after transplant. This~     medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients~     will also receive standard treatment to prevent GVHD. Patients will undergo many tests that~     are standard for their treatment at West Virginia University (WVU), including blood tests to~     check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi~     Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function~     testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide~     blood samples for optional research related to the study.~   "
106310|NCT01665664|"~     Underfeeding in the critically ill patient is a common observable fact throughout intensive~     care units. Patients who develop caloric deficit during their stay in the ICU have been~     shown in previous reports to be associated with increased complications such as increased~     rate of infections, and nosocomial blood stream infections. Yet, other studies have shown~     that patients with moderate caloric deficit may be associated with better outcome than~     patients who receive higher levels of caloric intake.~   "
106311|NCT01665651|"~     Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or~     bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected~     with decrease of renal function. In traditional Chinese medicine, kidney function is~     considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment~     will help improve bone development and metabolism.~   "
106312|NCT01665638|"~     The purpose of this study is to assess whether treatment with a single oral 300 mg dose of~     canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a~     protein released from the pancreas during insulin secretion) in healthy adult volunteers.~   "
106313|NCT01665625|"~     Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic~     cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic~     cancer for over two decades and combinations of gemcitabine with different chemotherapeutic~     drugs have been investigated to improve the outcomes of pancreatic cancer. However, no~     substantial improvement in patient survival has been achieved. Locoregional chemotherapy via~     intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug~     concentrations and reducing systemic toxicities. In this study, the investigators hypothesis~     that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy.~     The investigators will analyze and evaluate the effect and safety of an implanted~     percutaneous left subclavian artery port-catheter drug delivery system for regional~     chemotherapy of inoperable pancreatic carcinoma.~   "
106314|NCT01665612|"~     The purpose of the clinical investigation is to assess the clinical and subjective~     performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two~     silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).~   "
106315|NCT01665599|"~     This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone~     concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy~     of testosterone gel (2%) delivered using an applicator.~   "
106316|NCT01665586|"~     Recently many studies reported that intraoperative dexmedetomidine administration undergoing~     spinal anesthesia give a satisfactory sedation in elderly patients and cause less~     respiratory depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose~     of dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was~     not got general consensus.~      The investigators hypothesized that the dose requirements would be lower than in elderly~     patients than young patients. Furthermore, intrathecal small dose opioids enhance the~     analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of~     dexmedetomidine.~      The purpose of this study was to determine the dose of dexmedetomidine to provide~     satisfactory sedation undergoing spinal anesthesia with or without additive small dose~     intrathecal opioids.~      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this~     single-blinded study. Forty patients were randomly assigned to receive intrathecal~     hyperbaric bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline~     0.4cc. After the induction (bilateral T10 sensory level to pinprick within 5 mins of~     intrathecal drug administration), continuous intravenous dexmedetomidine was started in dose~     of 0.8, 0.6, 0.5, 0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4~     within 20 minutes of dexmedetomidine infusion. The dose of dexmedetomidine was selected for~     each patient according to an up and down method. Intraoperative arterial pressure, heart~     rate, and bispectral index was compared. Postoperative pain score, the time for the~     regression of sensory and motor was recorded for further analysis.~   "
106317|NCT01665573|"~     The purpose of this double blind, randomized, controlled, proof-of-concept study is to test~     the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning.~     On three days over not more than two weeks, subjects will be trained to associate cues with~     two different stimuli, then this association will be extinguished. Cannabinoid receptor~     stimulation will be accomplished indirectly by harnessing the brain's capacity to~     endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents~     degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845.~     Some details of this study have not been disclosed to preserve the study design.~   "
106319|NCT01665547|"~     Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation~     induction in women with clomiphene resistant PCOS~   "
106329|NCT01665404|"~     This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on~     the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a~     single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a~     cross-over design. The anticipated time on study treatment is 40 days.~   "
106320|NCT01665534|"~     Salt is a main environmental risk factor involved in atherosclerotic complications and in~     the high risk of a variety of cardiovascular (CV) diseases including hypertension, left~     ventricular hypertrophy (LVH), chronic kidney disease (CKD) and heart failure. The link~     between sodium and cardiovascular disease is complex and involves blood pressure (BP)~     dependent and independent mechanisms. Among the latter, inflammation is suspected to be a~     major effector of arterial damage brought about by the salt excess in animal models. In~     humans, C-Reactive Protein (CRP) associated directly with dietary salt intake in a~     population-based survey but such a link was not confirmed in other studies. This apparent~     discrepancy may depend on the observational (i.e., open to confounding) nature of these~     studies. Inflammatory cytokines are essential for the short term systemic response to~     environmental stressors. For example it is well established that TNF-α, a cytokine that~     modulates renin gene expression by signalling via TNF-receptor 2, exerts a protective effect~     for the myocardium in a stressful condition like experimental cardiac ischemia while low~     levels of adiponectin have a detrimental effect in the same setting. Thus, the~     inflammation-sodium relationship may be non-linear and severe salt restriction may actually~     trigger inflammation, a hypothesis suggested by the observation that biomarkers of~     inflammation rose in response to salt depletion in a sequential study in essential~     hypertensives. However, the lack of randomization in this study leaves open the question~     whether the observed pro-inflammatory effect was due to change in salt intake or to other,~     unmeasured time-dependent effect(s). With this background in mind the investigators setup a~     randomized, single masked, cross-over study to assess the effect of a short term very low~     salt diet on biomarkers of innate immunity in patients with uncomplicated essential~     hypertension.~   "
106321|NCT01665521|"~     Our research will examine a chest pain care strategy, called the HEART pathway, which is~     designed to correctly identify Emergency Department patients at high-risk for cardiovascular~     events, likely to benefit from further testing, and patients at very-low-risk for~     cardiovascular events, who may be safely discharged home. By using an individual's risk~     assessment to determining testing, we hope to improve the quality and efficiency of the care~     delivered to Emergency Department patients with chest pain. Our study will determine if the~     HEART pathway, which combines a clinical decision rule, the HEART score, and two serial~     troponin measurements, will reduce stress testing and cardiovascular imaging, decrease~     hospital length of stay, and reduce cost compared to usual care, while maintaining safety.~   "
106322|NCT01665508|"~     Women have less significant blockages of coronary arteries, however have greater symptoms~     and worse outcomes compared to their age-matched male counterparts. This paradox has led to~     the recognition and importance of the microvasculature ( small vessels) as a contributor to~     symptoms and outcomes. Nebivolol has unique antioxidant properties and dilates blood vessels~     and it is therefore proposed that treatment with nebivolol will reduce angina (chest~     symptoms) in women with microvascular disease as well as improve exercise capacity, reduce~     resource utilization and improve other measures of artery function.~   "
106323|NCT01665495|"~     The DROP study is a prospective, multi center, randomized, open-label trial to test the~     efficacy and safety of extended catheter pericardial drainage in patients with non-malignant~     pericardial effusions.~   "
106324|NCT01665482|"~     Rationale: It is well established that increased intake of saturated fatty acids (SFA) is~     associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by~     dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to~     clarify the association between dietary fatty acids and metabolic risk markers beyond lipid~     profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy~     replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However,~     limited evidence is available on the effects of dietary fatty acids on insulin sensitivity~     and secretion. The current study is designed to investigate the effects of SFA versus MUFA~     versus CARB on insulinemic response and lipid metabolism in healthy individuals with central~     obesity.~      Study design: A randomized, crossover, single blind design study was carried out. The~     subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day~     during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein~     content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy~     intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d~     based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of~     the total energy intake. The CARB diet provided approximately 34 g/day experimental fat~     based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from~     total fat with the exchange from oleic acid (C18:1).~      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence~     insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid~     metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be~     comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin~     sensitivity, endothelial and vascular function and inflammation~   "
106325|NCT01665469|"~     Consumption of a high-fat meal results in a postprandial (fed-state) response characterized~     by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of~     low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of~     inﬂammation. This postprandial lipemia-induced oxidative stress mediated response to a~     high-fat meal has been suggested as a major contributor to the pathogenesis of~     atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption~     of foods rich in antioxidant compounds provides a defence source to compliment endogenous~     defence systems to protect against oxidative damage during pro-oxidant conditions.~      The hypothesis of the study is that tomato extracted lycopene will be able to decrease~     postprandial oxidation and inﬂammation in healthy weight men and women when compared to~     Placebo.~   "
106326|NCT01665456|"~     Kenya is one of the countries in sub-Saharan Africa that still experience high maternal~     mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000~     live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage,~     pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and~     anemia in pregnancy are responsible for the majority of these cases. Just under 44% of~     births in Kenya are delivered under the supervision of a skilled birth attendant.~      The overall objective of this study is to determine the effect of provider type in the~     occurrence and management of serious childbirth related complications among postpartum women~     at the community level in Bungoma and Lugari Districts of Western Province, Kenya.~      The proposed study will employ a case control study design in which women with obstetric~     complication(s)will be cases and women without obstetric complications will be controls.~     Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a~     control is selected from the population at risk in the neighborhood at that point in time.~      The study population will consist of women aged 15-49 years with a delivery in the past 12~     months. A woman who reports having experienced a birth-related complication will be~     recruited as a case while woman who reports having experienced no complication during~     child-birth will be recruited as a control.~   "
106327|NCT01665430|"~     This multicenter, open-label, single arm long term extension of study WA19926 will evaluate~     the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early, moderate~     to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible patients~     will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.~   "
106330|NCT01665391|"~     The primary objectives of this trial are as follows:~        -  to compare the achievement of a partial remission (PR) or complete remission (CR) in~          urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab~          versus placebo~        -  to compare the safety profile of patients treated with fresolimumab versus placebo~      The secondary objectives are as follows:~        -  To compare the reduction in proteinuria in patients treated with fresolimumab versus~          placebo~        -  To evaluate fresolimumab dose-dependent reduction in proteinuria~        -  To compare the change in renal function (estimated glomerular filtration rate [eGFR])~          in patients treated with fresolimumab versus placebo~        -  To evaluate the multiple-dose pharmacokinetics of fresolimumab~   "
106331|NCT01665378|"~     Low birth weight and anemia remain intractable problems in many developing countries despite~     considerable efforts to address them. Intervening with just prenatal iron-folate (IFA)~     supplements may not be the best approach given the substantial demands for iron by maternal~     and fetal tissues. Therefore, there is an urgent need to evaluate the additional~     contribution of prepregnancy interventions. We propose a double blind randomized controlled~     trial in rural Vietnam to evaluate the efficacy of weekly pre- pregnancy IFA or Multiple~     Micronutrient (MM) supplements on birth outcomes and maternal and infant iron status~     compared to providing only prenatal IFA supplements. This project is a collaborative effort~     between Emory University, USA and Thainguyen University of Medicine and Pharmacy, Vietnam.~     Eligible and willing women of reproductive age (WRA) will be assigned randomly to one of the~     following 3 groups of pre-pregnancy weekly supplementation: 1) FA (control) 2) IFA and 3)~     MM. All women will receive daily IFA when pregnant. We will recruit ~ 5000 WRA to obtain a~     sample of at least 1650 mother-infant pairs, which, at 90% power, will allow us to detect~     differences of ~ 60 g in birth weight between any two groups. Data on obstetric history,~     socio-demographic status, iron status, anthropometry and dietary intakes will be obtained at~     baseline. Key outcome measures will be 1) offspring's size and gestational age at birth 2)~     offspring's iron status at birth and 3 months of age and 3) maternal iron status at the~     beginning of pregnancy, 1 and 3 months post-partum. Intention to treat approach will be used~     to compare the various intervention groups. This study is timely and responds to the WHO~     Global Expert Consultation (2007) which identified the need to evaluate the long term~     benefits of weekly IFA and MM supplementation in WRA. The findings will provide the~     necessary evidence to policy makers to recommend weekly MM or IFA supplements to WRA to~     improve birth outcomes. The central hypothesis is that pre-pregnancy weekly IFA or MM~     supplementation followed by prenatal IFA and MM supplementation respectively, will improve~     birth outcomes as well as maternal and infant iron status compared to current practice of~     providing only prenatal IFA supplements. This hypothesis will be tested by conducting a~     randomized double-blinded placebo-controlled trial in Vietnam.~   "
106332|NCT01665365|"~     The aim of this prospective follow-up study is to investigate 5-year clinical outcome in~     patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning~     before primary percutaneous coronary intervention.~   "
106333|NCT01665352|"~     The purpose of this study is to compare the safety and effect of TTP054 versus placebo on~     glucose control in patients with type 2 diabetes.~   "
106334|NCT01665339|"~     Investigators presumed that preload consumers will have more weight reduction and lower risk~     of cardiovascular disease~   "
106335|NCT01665326|"~     This is a longitudinal natural history study of Infantile Pompe disease. The investigators~     will regularly collect and review medical information for up to 10 years regarding the~     diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa~     (Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those~     who have developed high and sustained antibodies to ERT. A subset of de-identified~     information about the natural history of Pompe disease and the response to treatment will be~     incorporated into the Lysosomal Disease Network (LDN) disease registry. The LDN is a~     nonprofit organization of scientists located around the world whose research focuses on~     Lysosomal disease.~      The specific aims of this study are:~        1. To determine and correlate Cross-Reactive Immunological Material (CRIM) status with the~          GAA gene mutations found on these patients~        2. To validate an approach for determining CRIM status from whole blood sample, with the~          gold standard determination of CRIM status by skin fibroblasts and mutation analysis~        3. To explore the clinical treatment response and natural history of CRIM-positive and~          CRIM-negative Pompe disease patients with and without immune modulation~        4. To investigate the role of immune response to treatment~   "
106336|NCT01665313|"~     The attention and clinical performance of physician might be decreased after outpatient~     clinic session compared to those measured before outpatient clinic.~   "
106337|NCT01665300|"~     Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type~     2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment~     has been mandated to detect myocardial dysfunction because of the risk of heart failure with~     this treatment. Myocardial deformation imaging is a sensitive means of detecting LV~     dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.~     The aim of this study was to investigate whether changes in tissue deformation, assessed by~     myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than~     conventional echocardiographic measures in patients treated with trastuzumab.~   "
106338|NCT01665287|"~     Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The~     commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to~     test for their relative sensitivity for low oxygen levels just after birth on term infants~     born by elective cesarean section. Reproducibility will be examined by replacements of the~     sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be~     used.~   "
106339|NCT01665274|"~     The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative~     chemotherapy is superior or not to operation directly for locally advanced gastric cancer in~     terms of 3 year disease-free survival (DFS) rate.~   "
106340|NCT01665261|"~     The purpose of this study is to test the accuracy of 7 indicators in screening congenital~     heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these~     indicators could be applied in the nationwide newborn CHD screening. The investigator's~     hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable~     accuracy.~   "
106341|NCT01665248|"~     The purpose of this study is to evaluate the correlations between active calcification and~     vulnerable plaque.~   "
106342|NCT01665235|"~     Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with~     intracranial artery stenosis~   "
106343|NCT01665222|"~     The study was to evaluate the relative bioavailability of morphine and~     morphine-6-glucuronide from 2 tablet products and determine if the 2 products were~     bioequivalent to each other.~   "
106344|NCT01665209|"~     The study was to evaluate the relative bioavailability of morphine and~     morphine-6-glucuronide from 2 tablet products and determine if the 2 products were~     bioequivalent to each other.~   "
106346|NCT01665183|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has~     been used to treat patients that have cancers that require arginine. In this study, ADI will~     be combined with the well known chemotherapy cisplatin, and the safety and potential~     efficacy of this combination will be explored in patients with cancers that require~     arginine.~   "
106347|NCT01665170|"~     A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora~     incarnata L. in an acute stressful situation~   "
106348|NCT01665157|"~     The purpose of this study is to evaluate the efficacy and the acceptability of low-residue~     diet package (Enimaclin®) as diet control before colonoscopy.~   "
106349|NCT01665144|"~     Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable~     treatment duration in patients with secondary progressive multiple sclerosis (Core Part)~     followed by extended treatment with open-label BAF312 to obtain data on long-term safety,~     tolerabiilty and efficacy (Extension Part).~   "
106350|NCT01665131|"~     Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high~     risk of sudden cardiac death. They are used to treat life threatening heart rhythm~     disorders. They have conventionally consisted of a generator sitting under the skin of the~     chest and leads which pass from veins in the collar bone region to the heart. Problems with~     these devices can necessitate extraction, with the commonest reason being infection. If~     extraction is required for infection then re-implantation is usually deferred for~     approximately one week whilst antibiotics are given so that the risk of infection of the new~     device can be minimised. This has considerable implications for healthcare resources. A new~     ICD has been developed that is entirely subcutaneous with no intravenous element. It is~     already in clinical use and is positioned remote from conventional ICD sites. With no~     intravenous element there is very little risk of infection in the blood affecting the new~     device. It is therefore likely to be possible to re-implant these devices immediately after~     extracting a conventional system. The aim of this research is to assess the outcome in~     patients re-implanted with this device immediately after conventional ICD system extraction.~     This data will be compared compared to those who have conventional systems re-implanted~     after the necessary delay.~   "
106351|NCT01665118|"~     The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio~     Frequency) device in the reduction of thigh circumference.~   "
106352|NCT01665105|"~     The purpose of this present study was to investigate the effect of electroacupuncture at~     both Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular~     activity, and skin blood flow and skin temperature. The investigators use pulse rate~     variability to investigate autonomic nerve modulates cardiovascular function, and using~     distant skin blood flow and skin temperature recordings to investigate the relationship~     between the same names meridian of hand and foot.~   "
106353|NCT01665092|"~     Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate~     oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling~     and cardiac mechanical efficiency. The overall goal of this proposal is to investigate~     L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators~     will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor~     dependent septic shock will significantly reduce cumulative organ failure at 48 hours with~     an associated decrease in 28-day mortality suggesting the need for further phase III study.~     To accomplish this the investigators will conduct a phase II, double blinded, placebo~     controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent~     septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or~     high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early~     resuscitative care.~   "
106354|NCT01665079|"~     The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of~     a single bolus dose of propofol in obese patients and to extract a time to peak effect~     (t-peak) from the estimated model parameters.~   "
106355|NCT01665066|"~     The aim of the present study is to compare serum nicotine levels of different e-Cigarette~     strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be~     also compared.~   "
106356|NCT01665053|"~     The purpose of this study is to assess the safety and effectiveness of the SYNERGY~     Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects~     with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary~     arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).~   "
106357|NCT01665040|"~     The primary objective of this study is to investigate patient satisfaction with treatment~     using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.~   "
106358|NCT01665027|"~     The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to~     2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction~     in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of~     delivery by vacuum in C/S with normal caesarean section.~   "
106359|NCT01665014|"~     The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole~     preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT)~     followed by high-dose melphalan used prior to second autoHSCT is safe and effective in~     patients with multiple myeloma (MM).~   "
106360|NCT01665001|"~     The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if~     individual therapeutic approach taking into account biological and phenotypic differences as~     well as response at the level of minimal residual disease is associated with improved~     outcome of adults with precursor lymphoid neoplasms~   "
106396|NCT01664533|"~     This prospective, multicenter observational study will evaluate the efficacy, safety, and~     tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after~     pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until~     withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.~   "
106397|NCT01664520|"~     The purpose of this study is to investigate how dexmedetomidine affects static and dynamic~     autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal~     subarachnoid haemorrhage (SAH) patients.~   "
106361|NCT01664988|"~     Gestational hypertension is the main cause of maternal and fetal mortality, however, it has~     no definite effective treatment. nowadays, the stress management approaches are use for~     essential hypertension. So, this study aimed is study the effect of progressive muscular~     relaxation and breathing control technique on blood pressure during pregnancy.~      this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental~     hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic~     blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups~     of progressive muscular relaxation, breathing control and control. In tow experiment groups,~     exercises were controlled by one day personally and the rest by CD, BP before and after~     interventions was controlled for 4 weeks. In control group blood pressure was measured~     before and after 15 minutes with no intervention.~   "
106362|NCT01664975|"~     The purpose of this study is to evaluate the efficacy and safety of GDPT regiment~     (gemcitabine，cisplatin,Prednisone ,Thalidomide~      ) for patients with Peripheral T-cell lymphoma.~   "
106363|NCT01664962|"~     The purpose of this study is to investigate the possibility of an association between~     Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic~     markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase~     (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).~   "
106364|NCT01664949|"~     This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop~     formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops~     (OPTIVE™) in subjects with dry eye disease.~   "
106365|NCT01664936|"~     The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence~     or effect that is used with a standard clinical PET/CT and/or investigation scans can be~     done in order to capture tumor sizes. The investigators believe endoscopies and surgical~     procedures could benefit from this type of imaging in the future. The Cerenkov imaging could~     be used as a guide for surgical resections.~      The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or~     other investigational tracers to image tumors and its sizes in the head, neck, breast,~     axillary and pelvic regions with a highly sensitive camera. The investigators will be trying~     to see if we can get another picture of the tumor using the Cerenkov light as part of the~     standard clinical scan or therapy.~   "
106366|NCT01664923|"~     The purpose of this study is to determine the safety and efficacy of enzalutamide vs~     bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have~     disease progression despite primary androgen deprivation therapy.~   "
106367|NCT01664910|"~     The goal of this clinical research study is to learn which dose level of inotuzumab~     ozogamicin (CMC-544) work best when given with fludarabine and bendamustine, with or without~     rituximab, before a stem cell transplant.The safety of this treatment will also be studied.~      Fludarabine, bendamustine, and rituximab are commonly given before stem cell transplants.~     These drugs are designed to kill cancerous cells and suppress your immune system in order to~     lower the risk of stem cell transplant rejection.~      Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer~     coming back.~   "
106368|NCT01664897|"~     The goal of this clinical research study is to learn if erlotinib can help to control AML.~     The safety of this drug will also be studied.~   "
106369|NCT01664884|"~     The aim of this study is to explore the levels of internalized stigma in a sample of young~     patients with bipolar disorder or schizophrenia.~   "
106370|NCT01664871|"~     There is growing worldwide interest in the use of diammine silver fluoride (DSF) as a~     topical agent to treat dentin hypersensitivity and dental caries. It has been available in~     various formulations for many years, but its safety profile has never been fully~     characterized.~      This preliminary study determined the applied doses (3 teeth treated), maximum serum~     concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults~     over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride~     selective electrode, and silver was determined using inductively coupled plasma-mass~     spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 µL).~   "
106371|NCT01664858|"~     CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in~     patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic~     Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical~     practice (defined by international guidelines). The study hypothesis is that 3Tesla~     CMR-guided management of patients with suspected stable angina is superior to current~     clinical practice based on 1) the principles of the National Institutes for Clinical~     Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of~     avoiding study-defined unnecessary invasive coronary angiography.~   "
106372|NCT01664845|"~     The aim of the study is to investigate the treatment response of metformin, Peg-IFN and~     ribavirin combination therapy for chronic hepatitis C virus (HCV).~   "
106373|NCT01664832|"~     The purpose of this study is the examination of the hypothesis that synchronized nasal IMV~     as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants~     immediately after extubation when recovering from Respiratory distress syndrome (RDS).~      Another objective is to examine the effects for synchronized non-invasive mechanical~     ventilation on gas exchange and cerebral oxygen saturation.~   "
106374|NCT01664819|"~     Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor~     Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from~     1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural~     villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15~     mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no~     significant difference in cataract formation between the antioxidant group and placebo. In~     this follow-up study, we will return to study villages to determine whether rates of~     cataract surgery are different in the 2 groups.~      1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts~     Study: effects of antioxidant supplements on cataract progression in South India. The~     British journal of ophthalmology 2006;90:847-51.~   "
106411|NCT01664117|"~     This observational multicenter study will evaluate the management of disease and safety in~     clinical practice in patients with moderate to severe rheumatoid arthritis receiving any~     biological therapies in monotherapy.~   "
106375|NCT01664806|"~     Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy~     operation. The appearance of burns are common following laparoscopic cholecystectomy;~     particularly at the port site of the active electrode. Willson et al found that 9 out of 19~     skin biopsies from the skin adjacent to the port site of the monopolar instrument's active~     electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)~     11:653] Authors have speculated that using different generator modes may lead to less~     capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support~     these speculations.~      The investigators hypothesize that capacitive coupling electrosurgical injuries from~     monopolar instruments are occurring during laparoscopic cholecystectomy operations. The~     investigators hypothesize that use of blend modes will reduce the incidence of capacitive~     coupling thermal injuries during laparoscopic operations in comparison to coag modes.~   "
106376|NCT01664793|"~     The purpose of this study is to increase childhood influenza vaccination rates using the FDA~     licensed influenza vaccines according to national guidelines in a randomized cluster trial~     in which primary care offices are randomized to intervention or control with the control~     group receiving the intervention in the second year.~   "
106377|NCT01664780|"~     Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI)~     imaging to assess liver fibrosis in patients after orthotopic liver transplantation.~      Material and methods: We prospectively assess the performance of ARFI imaging in planned 100~     patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left~     and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the~     results with clinical data and B-mode criteria.~      ARFI elastometry is an increasingly popular non-invasive method for the assessment of~     hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically~     in patients after orthotopic liver transplantation. Therefore we want to establish standard~     values in this population.~   "
106378|NCT01664767|"~     The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the~     airways characterized by fixed airflow obstruction, with important systemic co-morbidities.~     The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette~     smoking is the major cause of this disease. COPD is an important cause of morbidity and~     mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in~     the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide~     anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative~     processes at the cellular level. These molecules can alter the extracellular matrix~     remodeling, cell respiration, cell proliferation, cellular repair and the immune response in~     the lung. All these events are key elements in the pathogenesis of COPD.~      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled~     corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal~     inhalation treatments are a therapeutic strategy used since many years in an empirical way~     in patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients~     with COPD are very limited.~      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water~     inhalation on oxidant stress in the airways of stable COPD patients.~   "
106379|NCT01664754|"~     This phase I trial studies the side effects and best dose of exemestane in combination with~     pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV~     non-small cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some~     of the enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium~     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving exemestane together with pemetrexed~     disodium and carboplatin may kill more tumor cells~   "
106380|NCT01664741|"~     The proposed research will provide significant new gender-specific information of scientific~     and clinical relevance on the function of the mu-opioid system in nicotine dependence and~     therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to~     explain the differences in the prevalence of smoking in men and women, sex-specific~     differences in nicotine craving and withdrawal as well as the poorer therapeutic response to~     NRT. This work may pave the way to the design of improved pharmacotherapies that can more~     effectively target the endogenous opioid system in the treatment of nicotine dependence.~   "
106381|NCT01664728|"~     The purpose of this study is to provide access to abiraterone acetate for patients who have~     completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and~     continue to receive clinical benefit from this treatment.~   "
106382|NCT01664715|"~     The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels~     of recommended exercise in initially overweight and obese sedentary men and women on the~     prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of~     decreased energy intake (EI) and increased energy expenditure (100 minutes of physical~     activity per week). Participants achieving clinically significant weight loss (> 5% of~     initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy~     expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American~     College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per~     week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of~     weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12~     mos.).~   "
106383|NCT01664702|"~     The investigators propose a randomized trial comparing higher levels of dairy intake~     compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,~     overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each~     participant will be randomized to either higher or lower levels of dairy intake. A baseline~     calorimeter stay will determine 24-hour energy needs. Participants will then receive the~     diet they have been randomized to receive for 6 days and will then have a second calorimeter~     stay. During this 2nd stay, each participant will continue to receive the diet they were~     randomized to receive and will achieve a 300 kcal energy deficit through physical activity.~     The investigators hypothesize that children who receive a 300 kcal energy deficit from the~     energy expenditure of exercise and receive 3 to 4 servings of dairy products will show~     greater increases in fat oxidation compared to children who receive a 300 kcal energy~     expenditure of exercise and receive 1 or fewer servings of dairy products.~   "
106384|NCT01664689|"~     Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by~     providing endothelial protection, maintaining space, as well as facilitating surgical~     maneuvers, including IOL implantation. Equally important is the ease of use, good~     visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as~     a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%~     hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these~     in clinical scenarios, there is no randomized trial comparing intraoperative performance and~     postoperative outcomes. The aim of this study was to compare intraoperative performance and~     postoperative outcomes following microcoaxial phacoemulsification when using one of the~     three OVDs~   "
106385|NCT01664676|"~     Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect~     against diabetic nephropathy. We hypothesise that this is also the case in humans. This~     study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys~     in type 2 diabetic patients. Impact on basic kidney physiological will be determined and~     kidney injury markers will be measured as surrogate parameters of kidney protection.~   "
106386|NCT01664663|"~     The purpose of this study is to examine the valu of individually dose escalated radiotherapy~     compared with a standard dose of radiotherapy combined with standard concomitant~     chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with~     good performance status.~   "
106387|NCT01664650|"~     The 15-25% of the population of developed countries suffers for metabolic syndrome. It is~     associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5-~     9 fold increase in developing type II diabetes. MS prevalence increases after the onset of~     menopause, because of estrogen deficiency. It is still not clear if menopause itself~     increases the risk of cardiovascular diseases in al women or only in those that develop MS.~     Many MS patients that show slight modification in cardiovascular and metabolic parameters~     are not generally pharmacologically treated since diabetes or alteration in the lipid~     profile are not evidenced. In this respect it is of importance to develop new therapeutic~     strategies to prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a~     potentially preventive role on the cardiovascular apparatus in post-menopausal women, may be~     termed as selective ER modulator (SERM), since it reveals both ER-alpha full agonist and~     ER-beta partial agonist activity.~   "
106388|NCT01664637|"~     The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given~     prior to meals three times a day compared to placebo (capsule that looks like active study~     drug but contains no active drug), administered for 12 weeks, in diabetic subjects with~     symptoms associated with gastroparesis.~   "
106389|NCT01664624|"~     The purpose of this study is to assess the effect of roflumilast plus alogliptin on~     glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.~   "
106390|NCT01664611|"~     Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the~     peri/immediate post infarct period. However little is known as to the effect of repeated~     remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on~     ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial,~     the investigators intend to carry out daily remote ischaemic conditioning in post MI~     patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks~     following a heart attack improves the ejection fraction at 4 months as assessed by cardiac~     magnetic resonance imaging.~   "
106391|NCT01664598|"~     This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate~     the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to~     severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible~     patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104~     weeks.~   "
106392|NCT01664585|"~     The aim of this intervention study is to examine whether tailored exercise therapy training~     is effective and cost-effective to decrease headache frequency and intensity, reduce~     medication used for chronic headache and patients´ absence from work, improve their neck~     muscle force, cervical spine mobility, functional ability and quality of life, and increase~     general physical activity in chronic headache women at regular work during a 6-month~     intervention.~      The intervention itself with pilot-tested upper-neck specific exercise regimen aims that~     patients would independently commit to train and exercise to reduce their headache, and thus~     increase their quality of life. In addition, reduced pain and frequency of headache may~     increase the objectively measured daily physical activity of chronic headache patients.~   "
106393|NCT01664572|"~     Microcirculation, especially skin microcirculation, is a window towards systemic vascular~     function in magnitude and underlying mechanisms. Different techniques have been developed to~     assess the microcirculation. Among these techniques, laser technology is used to perform~     non-invasive microvascular assessments. Although this technique is widely used, different~     methodological issues remain. This study aims at defining the way to use lasers for clinical~     use.~   "
106394|NCT01664559|"~     Intrauterine device (IUD) placement can be painful for patients during and after the~     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly~     effective long acting reversible contraception. Currently there are no proven effective~     methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and~     Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after~     IUD insertion although it is used by some providers for this purpose. It is a strong NSAID~     that is indicated for the treatment of moderate acute pain. In the intramuscular form it has~     an analgesia onset of action at 30min, thus may be a plausible option for pain management in~     the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia~     and have not been proven to be effective in reducing pain associated with IUD placement. The~     primary aim of this study is to determine whether ketorolac (Toradol) decreases pain~     associated with intrauterine device placement compared to placebo. We hypothesize that~     administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion~     will decrease pain scores by at least 20mm on a visual analog scale at various time points~     during IUD insertion when compared to placebo of normal saline injection.~   "
106395|NCT01664546|"~     An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by~     aCGH in Trophectoderm Biopsy~   "
106398|NCT01664507|"~     Croup is common illness presenting emergency department with dyspnea. The main treatment for~     croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized~     L-epinephrine is restricted that the study of comparision between racemic epinephrine and~     L-epinephrine.~      The investigators conducted this study to compare the effectiveness of low dose~     L-epinephrine with conventional dose L-epinephrine.~   "
106399|NCT01664494|"~     This multi-center observational study will evaluate the use of Xeloda (capecitabine) in~     patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced~     gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving~     treatment with Xeloda according to product label will be followed for up to 10 months.~   "
106400|NCT01664273|"~     Gene transfer by electroporation (gene electrotransfer) uses short electric pulses to~     transiently permeabilise the cell membrane enabling passage of plasmid DNA into the cell~     cytosol. It is an efficient non-viral method for gene delivery to various tissues. In this~     phase I dose-escalating study, patients will be treated with intramuscular gene~     electrotransfer of plasmid AMEP. Plasmid AMEP encodes protein AMEP which bind to α5β1 og~     αvβ3 integrins. Primary end point of the trial is safety and secondary end points are~     efficacy, pharmacokinetics and evaluation of potential discomfort associated with the~     treatment procedure using VAS (Visual Analogue Scale).~   "
106401|NCT01664260|"~     It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating~     neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine~     augmentation will help reduce symptoms in patients with posttraumatic stress disorder as~     well as improve cognitive functions. We also expect that the N-acetylcysteine augmentation~     will induce change in structural, functional, and neurochemical aspects of the brain.~      In this study, we plan to conduct a randomized, double-blind, placebo-controlled~     augmentation study with N-acetylcysteine in addition to escitalopram. We will assess the~     efficacy and safety of the N-acetylcysteine augmentation.~   "
106402|NCT01664247|"~     This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial~     is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide~     (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with~     type 2 diabetes qualifying for treatment intensification.~   "
106403|NCT01664234|"~     Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.~     Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,~     trisomy 21, or similar congenital malformations. Patients with American Society of~     Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital~     heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy~     with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided~     by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the~     AirTraq. Randomization (1:1) will be based on computer-generated codes with random block~     sizes and stratified by hospital; allocation will be concealed and provided to clinicians~     via a secure web site that will be accessed shortly before induction of anesthesia.~   "
106404|NCT01664221|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of multiple intravenous dose. The objective of this randomized,~     parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug~     Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the~     reticulocyte count following a multiple intravenous administration during 4 weeks of 100~     IU/kg in healthy subjects.~   "
106405|NCT01664195|"~     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and~     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects~     following administration of single intravenous dose. The objective of this randomized,~     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of~     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced~     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count~     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.~   "
106406|NCT01664182|"~     This randomized phase II trial studies how well trebananib with or without bevacizumab,~     pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients~     with kidney cancer that has spread to other places in the body and usually cannot be cured~     or controlled with treatment. Trebananib may stop the growth of tumor cells by blocking~     blood flow to the tumor. Bevacizumab, pazopanib hydrochloride, sorafenib tosylate, and~     sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth or by blocking blood flow to the tumor. It is not yet known whether giving~     trebananib with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or~     sunitinib malate is more effective in treating kidney cancer.~   "
106407|NCT01664169|"~     RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic~     cancer treated on study CALGB-80303.~   "
106408|NCT01664156|"~     1. Objectives~             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet~               in women~             2. to establish scientific evidence for the use of Korean red ginseng by~               investigating changes of infrared thermography~        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity~          of hands and feet more effectively than placebo after 8 weeks administration of~          interventions- Korean red ginseng or the placebo.~   "
106409|NCT01664143|"~     This single-center, randomized, double-blind, placebo-controlled study will evaluate the~     safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers~     will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time~     on study treatment is 14 days.~   "
106410|NCT01664130|"~     This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating~     patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue~   "
106413|NCT01664091|"~     This research study is being done to carefully evaluate the effect of giving radiation~     therapy after temporary breast reconstruction. The investigators want to see if this type of~     reconstruction combined with radiation will look better (once the final reconstruction has~     been completed) and will reduce the risk that the participant will develop complications~     that sometimes occur with other kinds of reconstruction procedures. The investigators also~     want to know if it is easier to give the radiation with this type of reconstruction than~     with other kinds of reconstruction procedures. The reconstruction procedure involves the~     temporary use of a tissue expander and an acellular dermal matrix (ADM).~   "
106414|NCT01664078|"~     The purpose of this study is to evaluate the safety and effectiveness of InCraft® in~     subjects with abdominal aortic aneurysms requiring endovascular repair.~   "
106415|NCT01664065|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     Ceftaroline in a group of patients with renal disease and matching healthy subjects with~     normal renal function~   "
106416|NCT01664052|"~     This study has been designed to evaluate an investigational model of the Essure System for~     Permanent Birth Control. The investigational device is designed to offer all the advantages~     of the currently approved device. In addition, the investigational device offers immediate,~     permanent contraception without a three-month waiting period or 90-day confirmation test.~     This study has been designed to evaluate the effectiveness of the investigational device in~     causing tubal occlusion from insert placement through three months of wearing.~   "
106417|NCT01664039|"~     The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular~     pressure (IOP) and ocular surface and inflammatory biomarkers.~   "
106418|NCT01664026|"~     To evaluate the effect of a 6-month web-based lifestyle modification program with and~     without telephone counseling versus usual care in obese patients with cardiovascular risk~     factors on:~        -  Weight Loss~        -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,~          HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.~        -  Physical activity and eating habits~        -  Quality of life~   "
106419|NCT01664013|"~     The purpose of this study is to investigate the impact of botulinum toxin treatment in~     quality of life(QoL) in cervical dystonia patients~   "
106420|NCT01664000|"~     In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important~     role in protecting the body. p53 functions by activating proteins that repair DNA and kill~     cells that have genetic mutations such as in cancers. Research experiments showed that when~     cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that~     inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of~     apoptosis), a protein that causes tumor cell death. Because of these activities, slowing~     cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.~   "
106421|NCT01663987|"~     A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess~     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in~     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an~     acute exacerbation (Hospital Discharge 1)~   "
106422|NCT01663974|"~     The study aims to evaluate:~        -  the frequency of subsyndromal symptoms or disorders observed during interepisode phases~          in bipolar patients, particularly after a depressive episode in which these~          subsyndromal disorders are the most frequent~        -  the functional impact of these disorders, factors or symptom thresholds associated with~          functional remission, and factors associated with symptomatic remission over a~          sufficient follow-up (12 months).~   "
106423|NCT01663961|"~     A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on~     YM178, when the latter is taken on a continuous basis, in order to establish that there is~     no risk to patients who may take this combination of drugs.~   "
106424|NCT01663948|"~     The purpose of the international plastic bronchitis registry is to understand the natural~     course and long term health outcomes of subjects diagnosed with plastic bronchitis due to~     different types of casts. This provides essential data for identifying best practices and~     treatments. The secondary aim is to understand the structure of casts and mechanism of their~     formation.~   "
106425|NCT01663935|"~     The purpose of the study is to evaluate and document physiologic and functional changes in~     visual performance and retinal function of patients diagnosed with albinism (a dopamine~     deficiency state) following a trial of oral Levodopa/carbidopa treatment.~   "
106426|NCT01663922|"~     The purpose of the study is to look at whether taking a new medication for hepatitis C~     (boceprevir) together with a herbal remedy commonly used for the treatment of depression~     (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir~     is taken on its own.~      Treatment of hepatitis C genotype-1, has recently been significantly improved with the~     addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to~     this class of antiviral drugs and it is administered in combinations with other drugs to~     treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood~     (depression) for which treated patients may self-medicate with preparations containing St.~     Johns Wort (SJW).~      SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may~     result in a change in how both of these drugs usually work. It is therefore important to~     find out if the levels of boceprevir in the blood are significantly affected by taking SJW.~      The study aims to help us understand whether it will be safe to take SJW whilst being~     simultaneously treated for hepatitis C with boceprevir.~   "
106427|NCT01663909|"~     Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain~     management a complex task. Several studies have found out that pharmacological interventions~     alone were not enough to provide optimal pain management for these patients. The~     investigators developed a DVD on guided imagery, customized for teenagers, to help them cope~     better with their pain. The investigators believe that this type of intervention combined~     with their usual analgesic medication will help them to control their pain and foster~     rehabilitation.~   "
106428|NCT01663896|"~     To define and evaluate OCT stent guidance parameters through prospective data collection in~     PCI procedures of de novo lesions.~   "
112067|NCT01589419|"~     An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the~     PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with~     locally advanced rectal cancer (LARC).~   "
106429|NCT01663883|"~     Constant despite changes in perfusion pressure. It is observed in many vascular beds of the~     human body to prevent that variations in perfusion pressure are directly transmitted into~     changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased~     blood flow and bleeding or increased capillary pressure during increased blood flow.~      In the eye, several studies have reported that retinal blood flow is autoregulated over a~     wide range of ocular perfusion pressures. Unfortunately only few data are available for the~     optic nerve head. To gain data about autoregulation is of special importance given that~     several important ocular diseases such as glaucoma and age-related macular degeneration are~     associated with impaired autoregulation. In humans most data were collected using laser~     Doppler flowmetry.~      The present study aims to investigate the phenomenon of transient reduction in blood flow~     and to gain insight in the regulatory mechanisms of optic nerve head blood flow during~     isometric exercise.~   "
106430|NCT01663870|"~     The goal of this research study to learn about breast cancer survivorship and possible ways~     to improve breast cancer survivorship programs using technology.~      Objectives:~      Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the~     integration of patient navigation and an eHealth technology platform to improve care in the~     Survivorship Clinic at Lyndon B. Johnson Hospital.~      Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration~     of patient navigation and an eHealth technology platform to improve care for breast cancer~     patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.~   "
106431|NCT01663857|"~     A study for women with ovarian cancer that has returned at least 6 months after~     platinum-based chemotherapy.~   "
106432|NCT01663844|"~     This study includes two sub-trials. Both are included in this singe registration since they~     have parallel inclusion of participants and have been approved by the Swedish ethics board~     together in one application.~      Trial 1 includes patients with both insomnia and major or minor depression. Participants are~     randomized to either a combined therapist guided Internet-CBT for insomnia and depression,~     or to Internet-CBT for depression with an addition of a placebo intervention for insomnia.~     The primary purpose is to evaluate changes in insomnia and depression severity for the~     combination treatment compared to the depression treatment, after treatment and at 6 and 36~     months follow up. A secondary purpose is to evaluate cognitive functioning before and after~     treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County~     through mass media and the Internet psychiatry clinic's regular patient recruitment.~      Trial 2 includes patients with insomnia who do not meet criteria for major or minor~     depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks~     patients that are judged to be at risk of treatment failure are randomized to either~     continued treatment or treatment with added support intended to enhance outcome. The primary~     purpose is to evaluate change in insomnia severity for participants who get added support,~     compared to continued treatment with regular support level. A secondary purpose is to~     evaluate cognitive functioning before and after treatment, as well as cost effectiveness.~     Recruitment is done in the Stockholm County through mass media and the Internet psychiatry~     clinic's regular patient recruitment.~      NOTE:~      The first participants in trial 1 will be regarded as pilots, due to problems with the~     experimental treatment: technical issues as well as problems with the design of treatment~     modules. These problems were corrected when discovered. 12 participants in the experimental~     arm were affected by these errors. The pilot participants will not be included in the main~     analyses of data. This was decided upon on 31st of October 2014.~   "
106433|NCT01663831|"~     The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual~     Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these~     control methods tackle only indoor and night biting vectors. The proportion of transmission~     occurring outdoors and before sleeping hours or so-called residual transmission is~     steadily increasing and may compromise the effort towards malaria elimination.~      The purpose of this study is to raise evidence on the effectiveness of mass use of topical~     repellents in addition to LLINs in controlling malaria infections.~      A multidisciplinary approach will be used to collect information on the most important~     factors that contribute to the successful reduction of residual malaria transmission. In a~     first objective the epidemiological efficacy of repellents on prevalence of malaria carriers~     and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly~     assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a~     cross sectional random sample of 65 people will be drawn at the beginning and the end of the~     malaria season to obtain an estimate of the malaria prevalence. The second objective will~     handle the entomological efficacy and persistence of the topical repellent on malaria~     vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will~     be studied in a third objective.~   "
106434|NCT01663818|"~     A multi-center, post-CE Mark study designed to evaluate the performance of the Intact~     Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.;~     post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty~     (PTA) of superficial femoral or popliteal artery(ies).~   "
106435|NCT01663805|"~     This is an open, randomized, single-center study. The selected patients will be first~     divided into two major groups according to the type of organ to be transplanted: standard~     criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly~     allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).~      All patients received induction therapy with basiliximab (BXB) and maintenance with~     Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary~     objectives: To characterize the molecular profile of cytokines in kidneys obtained from~     deceased donors such as standard (SCD) and extended criteria (ECD) in biopsies taken~     before and after transplantation and to evaluate the effect of treatment with everolimus~     (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the~     pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of~     acute rejection and patient and graft survival.~   "
106436|NCT01663792|"~     Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC)~     incidence and mortality rates in Japan? This small proof of principle clinical trial was~     designed to test the idea that the same amount of seaweed normally eaten in Japan would~     induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American~     women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months.~     During the first month the capsules contained placebo, the second month seaweed, and the~     third month placebo. We collected blood and urine samples after each treatment period and~     tested for changes in protein expression that might be related to consuming seaweed.~   "
106473|NCT01663311|"~     Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways~     contributing to the perception of phantom sounds, and the regulatory neural network~     responsible for the generation of the individual amount of suffering caused by chronic~     tinnitus.~   "
106667|NCT01660763|"~     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab~     PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute~     moderate to severe post-operative pain after total unilateral knee or total unilateral hip~     replacement surgery.~   "
106437|NCT01663779|"~     Arterial catheterization is frequently performed on critically ill patients for invasive~     blood pressure monitoring and/or frequent blood draws, especially arterial blood gas~     analysis. The distal part of the radial artery (wrist) is the preferred access site.~      The potential complications of the procedure are mostly minor and comprise temporary~     occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture~     site. Major complications including vessel aneurysm or occlusion with threat to hand~     viability are rare.~      The standard approach to catheterization is blind puncture of the RA while locating its~     pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel.~     Alternatively ultrasound can be used to locate the vessel and guide needle insertion.~      To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with~     ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked~     at the pooled data obtained from these. The results showed that ultrasound guidance~     increased the first-attempt success rate at RA catheterization by 71% compared to palpation.~     The use of ultrasound also significantly reduced the time to successful catheterization, the~     number of punctures as well as the amount of catheters required per procedure.~      None of the prior randomized trials has been conducted in an ICU setting and in three out of~     the four studies the arterial lines were placed in patients undergoing elective surgery. The~     investigators hypothesized that ultrasound could improve first attempt success rate while~     placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to~     successful insertion and reduce complications.~      The investigators plan to randomize patients to either a palpation technique or ultrasound~     guided catheter insertion and record the above outcomes.~   "
106438|NCT01663766|"~     This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a~     standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic~     malignancies undergoing stem cell transplant.~   "
106439|NCT01663753|"~     Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and~     brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment.~     Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response~     to treatment before surgery. A positive predictive value of 75% was found in a small study~     making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach.~     Diffusion-weighted MRI was also described as an early and sensitive indicator in other~     diseases.~      Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET~     in the assessment of cervical cancer response to radiochemotherapy and brachytherapy.~     Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as~     diffusion-weighted MRI diagnostic performances.~      Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2~     cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a~     18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the~     brachytherapy. The total follow-up duration (study participation) of patients will be 11~     weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until~     18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.~      Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to~     assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it~     could improve clinical practices and be helpful to decide whether the patient needs surgery~     or not after radiochemotherapy and brachytherapy.~   "
106440|NCT01663740|"~     This observational study will compare spermatogenesis in male adult renal transp lant~     recipients receiving valganciclovir versus untreated matched controls. Data will be~     collected from each patient for up to 52 weeks post transplant.~   "
106441|NCT01663727|"~     This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to~     evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel~     in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast~     cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo.~     All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3~     weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV~     infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease~     progression, unacceptable toxicity or death from any cause occurs.~   "
106442|NCT01663714|"~     This is a phase II, open-label, multicenter study of the efficacy and safety of sequential~     administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly~     referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three~     cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and~     iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing~     three cycles of CVP may be removed from study.~      In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have~     completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131~     Anti-B1 Antibody if they have progressive disease documented at the response evaluation~     following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion~     exclusion criteria based upon the week 20 assessments, as applicable. Patients must also~     have an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab~     and iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131~     tositumomab must be given within 28 days of the response evaluation following CVP and no~     later than 56 days from the first day of the sixth cycle of CVP.~   "
106443|NCT01663701|"~     This study is a randomized control trial assessing the impact of a simple evidence-based~     protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up~     study to the Simplified Severe Sepsis Protocol (SSSP) study. The intervention protocol~     consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and~     blood transfusion when necessary. It is hypothesized that the protocol will significantly~     decrease in-hospital mortality in patients with severe sepsis and hypotension.~   "
106444|NCT01663688|"~     The purpose of this clinical study is to collect and evaluate the data from eye scans using~     an investigational three-dimensional eye imaging photography device called the Nidek Optical~     Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique~     that uses invisible wavelengths of light to make detailed images of the tissues at the back~     of the eye. These images provide information that physicians may use to help diagnose eye~     conditions and/or to monitor changes in the eye during treatment.~   "
106507|NCT01662869|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic~     Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth~     receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal~     junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or~     placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or~     placebo until disease progression, unacceptable toxicity, participant or physician decision~     to discontinue treatment.~   "
106445|NCT01663675|"~     Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability.~     Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10~     liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with~     trisomy 21, as well as medical care, social and educational integration in childhood was the~     subject of much research and has led to remarkable progress in terms of health and medical~     care, it is not the same for the knowledge about adolescents and adults.Despite a more and~     more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a~     deterioration in health status, with a regression of acquired psychomotor skills, often~     attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems~     that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well~     established that only a fraction of Down syndrome patients will develop this type of~     dementia. Too often a decline in general health, behavioral changes and decreased cognitive~     abilities are only attributed to the Down syndrome with an early dementia without looking~     for an underlying, potentially curable, disease.This study aims to better evaluate the~     health and social status of 100 adults with trisomy 21 in Alsace. The medical evaluation~     will include a comprehensive assessment of health status and quality of life conducted by~     the geneticist, a cardiac, sensory, hormonal, biological and radiological evaluation. A~     speech-language and psychomotor evaluation will also be conducted. A psychiatric~     consultation and a psychometric assessment will aim to assess cognitive function and to~     search for associated mood disorders.The expected results are to better know the natural~     history of trisomy 21 in adulthood, with the determination of the frequency of morbid events~     specific to adulthood, and also to improve the medical and paramedical care with the~     establishment of a monitoring program to prevent the occurrence of these morbid events.~   "
106446|NCT01663662|"~     It is well known that the use of loop diuretics in acute setting may decrease glomerular~     filtration rate (GFR) and increase serum creatinine leading to renal dysfunction. Loop~     diuretic induced elevation in serum creatinine can lead to increase in length of hospital~     stay and possibly morbidity. Previous studies have suggested that tolvaptan unlike~     aggressive loop diuretic therapy may not activate neurohormonal system nor decrease renal~     blood flow. These properties may make tolvaptan a useful addition to diuretic therapy to~     prevent renal dysfunction in high-risk patients. Therefore the primary objective of this~     study is to determine if the use of tolvaptan in combination with diuretic therapy may~     prevent development of renal dysfunction in high risk patients with heart failure.~      Hypothesis: Administration of tolvaptan in combination with continuous loop diuretic therapy~     in acutely decompensated heart failure patients at high risk for developing diuretic induced~     renal dysfunction will have a lower proportion of patients increasing their serum creatinine~     > 0.3 mg/dL within a 96 hour time frame as compared to patients just receiving standard of~     care continuous infusion diuretic.~   "
106447|NCT01663649|"~     200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are~     recruited via the multiple sclerosis clinics of the University Medical Center~     Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the~     online program deprexis or to a wait-list control condition. All participants receive~     free-of-charge online access to deprexis either immediately or with a six month delay.~      At three time points (1. prior to intervention, 2. after completion of the intervention nine~     weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous~     online survey, which was implemented using the software package OPST®.~      The survey consists of different questionnaires. The Beck Depression Inventory (BDI)~     represents the primary outcome (IIT analysis for pre versus post). It is assumed that the~     severity of depressive symptoms will improve to a significantly greater extent in the~     deprexis than in the wait-list control condition in the course of nine weeks and will be~     maintained in a six month follow-up.~   "
106448|NCT01663636|"~     To pilot test a mobile phone SMS system that will provide periodical messaging texts to~     mothers or custodians of infants who come for their first dose vaccines within the first 3~     months of life to improve timely immunization coverage, vaccine acceptance and ensure~     vaccine safety monitoring. The intervention will include a cloud-based information system~     alimented by mobile phone data entry at the health post nurse level, that links child~     vaccination status and is able to remind parents and nurses of the need for next vaccination~     appointment and provide a system for reporting of adverse events following immunization in~     the immediate post-vaccination period.~   "
106449|NCT01663623|"~     The purpose of this study is to evaluate the efficacy and safety of belimumab, in~     combination with azathioprine, for the maintenance of remission following a standard~     induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The~     random assignment in this study is 1 to 1 which means that participants have an equal~     chance of receiving belimumab or placebo.~   "
106450|NCT01663610|"~     This study is a randomized controlled trial (RCT) to evaluate the effect of an~     internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis~     or struggle with organizing daily life and/or easily get distracted. The course~     (vardagsSMART) teach the participants how to use a Smartphone to better organize their~     everday life and will be compared to a wait list control group (CONT) that later will~     recieve the same course without guidance from a supervisor(selfSMART). It is hypothesized~     that VardagsSMART will be superior to CONT on ability to organize everyday life and~     ADHD-symptoms, and that vardagsSMART will be superior to selfSMART on adherence,~     understanding and perecived usefullness.~   "
106451|NCT01663597|"~     Aberrations play a significant role in the visual process and can be divided in lower-order~     and higher-order aberrations. The former can be measured using the commercially available~     IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.~     Higher-order aberrations do not significantly influence visual acuity but affect the quality~     of vision and can cause halos, double vision, and night vision disturbances.~      Background Cataract surgery has become a routine procedure in the developed countries.~     During this surgery, a foldable intraocular lens is usually inserted into the capsular bag.~     However, these lenses do not account for individual optical biometry data or aberrations.~     Therefore, it is important to provide data for ametropic and emmetropic eyes as this~     information might improve future intraocular lens design and lead to individually adapted~     lenses for yielding optimal visual acuity and quality results.~      The aim of the present study is to clarify the correlation between refractive errors/axial~     eye length and spherical aberrations of the cornea.~   "
106508|NCT01662856|"~     The purpose of this study is to demonstrate that the application of Fibrin Sealant (FS)~     Grifols provides a measurable benefit when compared to hemostasis achieved through~     conventional surgical technique (suture) and by standard hemostatic action, such as~     mechanical pressure through manual compression (MC). This study has a Preliminary Part (I)~     in which all subjects are treated with FS Grifols and a Primary Part (II) in which subjects~     will be randomized in a 2:1 ratio to either FS Grifols or MC.~   "
133193|NCT01311635|"~     The purpose of this study is to study the relative bioavailability of AZD1981 when using a~     new tablet compared to the current tablet.~   "
106452|NCT01663584|"~     The purpose of this study is to collect blood samples to enable validation of genetic~     testing for diseases within a multi-disease carrier screening panel. Samples will be~     collected from adult women or men who have previously tested positive as carriers for~     various recessive conditions. These are healthy adults who carry a mutation that might place~     them at increased risk of having a child with a specific genetic disorder. Study~     participation will be open to adults that were previously tested as part of their routine~     medical care and where test results demonstrated positive carrier status for a specific~     genetic disease. Samples will be tested for the disease mutation for which the subjects~     provides documentation of prior testing.~   "
106453|NCT01663571|"~     Protocol Summary~      Constitutive STAT3 activity is implicated in many malignancies including Cutaneous T Cell~     Lymphoma. It is also essential for Th17 differentiation, a subset of CD4 effector T cell,~     implicated in chronic inflammatory conditions and possibly CTCL. HDAC inhibitors have shown~     activity in CTCL but their exact mechanism of action is not known. It is known that HDAC~     inhibitors regulate STAT3 transcriptional activity and hence can potentially be active in~     CTCL through modulation of the STAT3 pathway. The hypothesis is that Th17 cytokines~     contribute to the initiation of cancer by creating a pro-inflammatory microenvironment that~     predisposes cells to neoplastic transformation. To probe this, the investigators will~     compare the differences in cytokine production and gene expression in the skin resident T~     cells from patients with benign dermatoses and CTCL as well as in the blood/circulating~     lymphocytes of healthy donors and Sezary syndrome (SS). The investigators will also~     investigate whether HDAC inhibitors have a direct impact on the number of Th17 cells, the~     cytokine production by these cells and phosphorylated STAT3 protein in CTCL with subsequent~     treatment cycles.~      The objectives of this study are 1. Observe the epigenetic, transcriptional and phenotypic~     changes that take place in T cell during malignant transformation 2. Understand the~     mechanism of action of HDAC inhibitors in CTCL.~      Methods: Skin biopsy specimens from cutaneous T cell lymphoma (CTCL) patients and benign~     skin conditions namely eczema, dermatitis and psoriasis will be obtained through a standard~     punch biopsy procedure from the skin lesion.~      Additionally, 15 ml of peripheral blood from CTCL patients who have Sezary syndrome (SS) and~     from patients with benign skin condition will be collected.~      CTCL patients, who are starting treatment with HDAC Inhibitors namely Vorinostat and~     Romidepsin, will have a total of 3 skin biopsies and/or blood draws. The first procedure~     would be before starting treatment with either of these HDAC inhibitors. Two more skin~     biopsies and/or blood draws will be performed after first and second cycle of treatment.~      Levels of Th17 cytokines, IL-17, IL -22 and pSTAT3 protein will be determined by IHC~     staining in the skin and cytokine levels in the blood will be assayed by sandwich ELISA~     method.The investigators will also assay the mRNA levels of the transcription factors of the~     different T effector cells by qPCR.~   "
106454|NCT01663558|"~     Context:~      Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and~     anal squamous cell carcinoma; concomitant HIV infection roughly doubles that risk.~      Objectives:~        1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the~          management of anal dysplasia in HIV-infected men.~        2. To describe relationship between cytologic grade of anal dysplasia (as reported on~          screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic~          examination.~        3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of~          anal dysplasia.~        4. To describe adverse effects associated with ablative therapy and topical imiquimod~          therapy.~      Design:~      Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects~     will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN~     2 or 3 is discovered on histopathologic examination, subject will be offered observation~     only or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal~     suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as~     determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative~     group as their treatment will be completed in one visit) subjects will be followed for 2~     weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and~     anal HPV testing. After therapy completed in each treatment group, subjects will be followed~     for 1 month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA~     with biopsies as indicated, and anal HPV testing. Observation only subjects will be~     evaluated every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing~     for 12 months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects~     in the observation only group based on the likelihood of enrolling a study of this type in a~     reasonable amount of time.~      Main Outcome Measures:~        1. Anal Pap cytologic grade, including regression and recurrence during course of study~        2. HPV type in anal canal, including regression and recurrence during course of study~        3. Anal histology, including regression and recurrence during course of study~        4. Adverse effects experienced during treatment, recorded in symptom log~   "
106455|NCT01663545|"~     Background:~        -  The brain is protected by a barrier that keeps toxins in the blood from reaching the~          brain. However, this barrier can also keep useful medications from reaching the brain.~          P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The~          level of P-gp is higher in people with epilepsy than in people without epilepsy. These~          different levels of P-gp may explain why some people have seizures that do not respond~          well to medications. Researchers want to see if P-gp can affect the response to~          epilepsy medications.~        -  Epilepsy may also be associated with brain inflammation. Researchers also want to look~          at the part of the brain affected by epilepsy to see if inflammation is present.~      Objectives:~        -  To see if P-gp can affect the response to epilepsy medications.~        -  To see if inflammation is present in the part of the brain affected by epilepsy.~      Eligibility:~        -  <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We~          plan to study some patients whose seizures are well controlled by drugs, and some whose~          seizures are not controlled.~        -  <TAB>~        -  Healthy volunteers between 18 and 60 years of age.~      Design:~        -  This study requires four or five visits to the NIH Clinical Center over the course of a~          year. The visits will be outpatient visits and will last from 2 to 5 hours.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have two positron emission tomography (PET) scans. The scans will~          take place during different visits. Different drugs will be used in each scan. One drug~          will be used to temporarily block the effect of P-gp in the brain. The other drug will~          show areas of inflammation in the brain.~        -  Participants with epilepsy will have a third PET scan. This scan will also look at P-gp~          activity in the brain. However, it will not use the drug that blocks the effect of~          P-gp.~        -  All participants will also have one magnetic resonance imaging scan. This scan will~          help show brain function.~   "
106456|NCT01663532|"~     The primary purpose of this study is to evaluate the overall efficacy of aripiprazole~     intramuscular (IM) depot as acute treatment in subjects with schizophrenia.~      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot~     administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.~   "
106457|NCT01663519|"~     Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients~     at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from~     1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines~     Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the~     feet, education and prescription of insoles in combination with well fitting shoes are~     supposed to decrease the risk of ulcers and prevent amputation. Further research is,~     however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim~     of this study is to compare three different types of insoles with respect to pressure~     distribution. Every 6 months follow-up is assessed until 24 months is reached.~   "
106458|NCT01663506|"~     This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients~     initiated on RoActemra/Actemra treatment according to the local label will be followed for~     12 months.~   "
106459|NCT01663493|"~     This study will examine whether there is any difference in number of passes needed to~     diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different~     types of needles.~   "
106509|NCT01662843|"~     The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right~     ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial~     Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.~     Primary outcomes measured are the magnitude of change in differential diagnoses.~   "
106510|NCT01662830|"~     The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC~     Jump Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric~     changes, and reduction in common markers of coronary heart disease.~   "
106460|NCT01663480|"~     The primary purpose of mechanical ventilation is to sufficiently unload the respiratory~     muscles and maintain adequate ventilation in spontaneously breathing patients. When the~     mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the~     patient and the mechanical ventilator will contribute to the lung-distending pressure,~     necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately,~     conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory~     assist performed by the ventilator and the patient. Inadequate levels of assist are~     associated with adverse effects such as development of fatigue or patient-ventilator~     dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and~     weaning delay.~      The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to~     measure the neural activity of the respiratory centers (expressed by the diaphragm~     electrical activity, EAdi). EAdi is a validated variable to quantify the neural respiratory~     drive, little is known about its usefulness to evaluate the contribution of the patient's~     inspiratory muscle effort relative to that of the mechanical ventilator, which would be of~     crucial importance to appropriately titrate the level of assist.~      During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed~     as neuroventilatory efficiency (NVE), may be a useful predictor for determining the~     contribution of the patient and the ventilator to generate a breath.~   "
106461|NCT01663467|"~     The purpose of this study is to prove the efficacy of the internet and smartphone~     application-delivered tinnitus retraining therapy (TRT).~   "
106462|NCT01663454|"~     The purpose of this pilot study is to assist the preparation of a larger multi-center study.~     The main aim is to determine the feasibility of conducting computerized working memory~     training in a group of children with cerebral palsy.~   "
106463|NCT01663441|"~     This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the~     optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a~     multicenter randomized self-control trial involving 60 cancer patients undergoing~     chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified~     recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter~     randomized trial involving 240 cancer patients undergoing chemotherapy.~   "
106464|NCT01663428|"~     This study evaluates the ability of a newly designed splint called Sup-ER Splint to~     improve the arm function and anatomy of children with birth related brachial plexus~     injuries.~   "
106465|NCT01663415|"~     The purpose of this study is to investigate radiographic progression-free survival (PFS) of~     enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant~     prostate cancer who have symptomatic disease.~   "
106466|NCT01663402|"~     Primary Objective:~      To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events~     (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction~     (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in~     patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to~     randomization and are treated with evidence-based medical and dietary management of~     dyslipidemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD~          event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic~          stroke, all cause mortality).~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the effect of alirocumab on lipid parameters.~   "
106467|NCT01663389|"~     This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.~     This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,~     and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of~     blood, urine, and feces.~      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day~     screening period, two dosing periods (approximately 8 days each) and a follow up visit.~      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period~     and remain in the unit for up to approximately 16 days through the end of the second~     treatment period.~      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single~     therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is~     <1% of the administered dose in all subjects, Period 2 dosing will begin (approximately 8~     days after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic~     oral solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during~     both the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.~     Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge~     from the unit.~   "
106468|NCT01663376|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     critical limb ischemia~   "
106469|NCT01663363|"~     The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and~     effective for the correction of myopic refractive errors.~   "
106470|NCT01663350|"~     This is a prospective, multi‐center observational study designed to compare the test results~     of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal~     screening for fetal chromosome abnormalities in 'all-risk' pregnancies.~   "
106471|NCT01663337|"~     The broad, long-term objective of the current research is to improve treatment outcomes for~     individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and~     dependence (AUD).~      The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and~     cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP)~     treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.~      The study will randomize 235 PTSD/AUD participants recruited from the VA and from the~     community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the~     AO condition will be re-randomized after the treatment phase to either RP or CPT.~     Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and~     12-months post-treatment and will monitor symptoms daily throughout treatment.~   "
106472|NCT01663324|"~     Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory~     neural pathways contributing to the perception of phantom sounds.~   "
139722|NCT01225991|"~     The purpose of this study is to examine the effects of milnacipran for the treatment of pain~     in rheumatoid arthritis in older adults.~   "
106474|NCT01663298|"~     Periodontal wound healing is a complex multifactorial process that involves interactions~     among various cells, growth factors, hormones and extracellular matrices. Although still~     poorly understood, these interactions trigger a series of events that lead to new tissue~     formation. One growth factor that plays an important role in wound healing is fibroblast~     growth factor 2 (FGF2). Many animal and human studies have shown this protein is effective~     in periodontal regeneration. Recently, epigenetic modifications, such as DNA methylation,~     have been associated with changes in patterns of gene expression. Preliminary data suggests~     that FGF2 gene may be differentially methylated in periodontal tissues. Aberrant gene~     promoter methylation in smokers and diabetics has also been reported in many studies.~     However, the role of DNA methylation in wound healing has not yet been investigated.~      The investigators hypothesize that the methylation status of FGF2 gene can affect the levels~     of FGF2 secreted during wound healing phase after dental implant surgery. The investigators~     also hypothesize there exists a difference in methylation levels of FGF2 gene in healthy,~     smoking and diabetic patients that can interfere with wound healing. The investigators seek~     to determine whether DNA methylation plays a role in wound healing and whether the~     methylation level of FGF2 gene varies among healthy, smoking and diabetic patients.~   "
106475|NCT01663285|"~     The main purpose of this study is to look at the cancer-free survival at two years of~     subjects with high risk upper tract urothelial cancer when treated with the combination of~     two chemotherapy drugs called Gemcitabine and Cisplatin followed by surgery to remove the~     kidney, all or part of the ureter (ureters are tubes made of smooth muscle fibers that~     propel urine from the kidneys to the urinary bladder), and a cuff of bladder where the~     ureter drains into the bladder. Other purposes of the study include looking at the safety of~     Gemcitabine and Cisplatin before surgery for this type of cancer, time to recurrence of~     cancer, and overall survival.~      Exploratory integrative tumor sequencing:~      The purpose of this part of the study is to test deoxyribonucleic acid (DNA) and ribonucleic~     acid (RNA) in various types of samples (tissue and blood) to detect different types of~     cancer genetic changes in upper tract urothelial cancer (UTUC) to help develop future~     studies in UTUC. DNA and RNA contain key instructions for cell function and help determine~     the characteristics of each individual such as hair, eye, and skin color, height,~     susceptibility to diseases, and other characteristics.~   "
106476|NCT01663272|"~     Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is~     approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated~     effectiveness against pancreatic cancer in laboratory experiments, especially when given~     with gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some~     activity against the disease. The purpose of this study is to determine the safest and~     highest dose of cabozantinib that can be given together with standard doses of gemcitabine~     in patients with pancreatic cancer. This study will determine the safety and tolerability of~     this two drug combination.~   "
106477|NCT01663259|"~     Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal~     cancer with < 10 pack-year smoking, the investigators hypothesize that reducing the~     intensity of therapy for these patients will reduce treatment sequelae, notably long-term~     dysphagia, without affecting their cure rates. The main Aim is to assess whether reducing~     treatment intensity, by replacing concurrent chemotherapy with cetuximab, will indeed~     achieve improved long-term toxicity.~      The primary objectives include the following: to confirm that reducing treatment intensity~     in patients with HPV-related oropharyngeal cancer and < 10 pack-year smoking history by~     replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase~     the proportion of patients whose tumors recur, compared to our previous experience in~     similar patients receiving chemo-RT and to compare the toxicity in patients receiving~     cetuximab-RT to similar patients treated with 7 weeks of chemotherapy concurrent with RT~     (standard therapy) in UMCC 2-21.~   "
106478|NCT01663246|"~     The investigators are conducting research about oral health and saliva to find out more~     about the impact of radiation therapy on the oral health of patients.~      In order to better understand the role of saliva in maintaining oral health in these~     patients, the investigators will be collecting, storing, and analyzing the quality of~     saliva, including the protein content, collected from patients following radiation therapy~     as well as saliva collected from normal healthy adults.~   "
106479|NCT01663233|"~     This study will assess whether LCZ696 when used in combination with amlodipine will provide~     greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not~     adequately responsive to amlodipine therapy.~   "
106480|NCT01663220|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
106481|NCT01663207|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
106482|NCT01663194|"~     Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with~     adverse outcomes among patients with coronary artery disease, its role during the acute~     phase of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated.~     This study sought to investigate the association of the pre-procedural N/L ratio~     within-hospital and long-term outcomes among STEMI patients undergoing primary percutaneous~     coronary intervention (PCI).~   "
106511|NCT01662817|"~     The purpose of this study is to assess the effectiveness of systematic screening for~     depression in high-risk patient participants in everyday clinical practice. Systematic~     screening for depression in high-risk patients is recommended to be included as a usual~     practice but its effectiveness in this context remains controversial. In this study, 35~     primary care physicians (PCPs) in Spain were assigned to intervention (receive one day~     training in depression screening guidelines and use guidelines for six months) and 34 PCPs~     were assigned to a control group (manage depression in the usual way for six months). There~     were a total of 525 patient participants with MDD.~   "
106564|NCT01662258|"~     This is a prospective interventional study to assess laboratory testing which will identify~     the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent~     selection for patients with community acquired-pneumonia (CAP).~      Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with~     respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted~     narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to~     Empiric therapy in patients with viral pneumonia~   "
106483|NCT01663181|"~     At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled~     for outpatient cystoscopy or urodynamic testing will be asked to participate in the study.~     Patients will be called one day after the examination and will be asked about pain and their~     general state of health.~      The purpose of this study it to investigate pain perception in urogynecologic patients~     during outpatient cystoscopy and compare it with pain perception during outpatient~     urodynamic. The investigators will also investigate the difference between anticipated and~     actual pain perception. The investigators will test the null hypothesis that there is no~     difference in patients´ pain perception between outpatient cystoscopy and urodynamic~     testing. The secondary hypothesis will be that there is no difference between patients´~     anticipated amount of pain and the actually experienced pain during cystoscopy and~     urodynamic testing.~      According to power calculation, a sample size of 52 patients per group will be needed to~     detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant~     difference - with 95% power and a two-sided significance level of 0.05.~      Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy~     and the participation in another clinical study at the same time.~   "
106484|NCT01663168|"~     - Background and study aims?~      Some of the drugs used to treat HIV (anti-retrovirals, or ARVs) can affect the blood levels~     of other drugs used to treat TB - called a drug-drug interaction. The main drug used in~     second-line therapy, Aluvia (lopinavir/ritonavir), is one of the drugs that has this effect.~     This is why people on second-line ARVs usually cannot use one of the main TB drugs,~     rifampicin, and instead will be prescribed a slightly different drug called rifabutin,~     which is less affected by these drug-drug interactions. Although blood levels of rifabutin~     are not as badly affected by Aluvia as blood levels of rifampicin, rifabutin levels in the~     blood are still increased a lot by taking Aluvia at the same time. This could lead to higher~     levels of side-effects because there is more drug in the body. So in the past doctors have~     suggested that instead of taking rifabutin every day with Aluvia, it should only be taken~     three times a week, on Mondays, Wednesdays and Fridays. However, in the last 2 years, new~     studies have suggested that this three times a week regimen might not be enough and that it~     may not completely cure TB. So the purpose of this study is to find out whether taking~     rifabutin every day with Aluvia really does lead to more side-effects, and whether taking~     rifabutin three times a week with Aluvia really does lead to much lower levels of rifabutin~     in the blood.~      - Who can participate?~      This substudy is specifically for people who are already taking anti-TB drugs in EARNEST, or~     who need to start anti-TB drugs whilst they are in the EARNEST trial.~      - What does the study involve?~      Participants will be selected (by chance, chosen by a computer) to one of the following two~     rifabutin groups:~      Group 1: Rifabutin (150 mg) taken three times a week on Monday/Wednesday/Friday Group 2:~     Rifabutin (150 mg) taken every day On these days, one capsule of rifabutin (150 mg) should~     be taken in the morning by mouth.~      Participants will be asked to attend clinic 2 and 12 weeks after entering the sub-study then~     every 6 weeks until the end of their TB treatment, and then return to their usual EARNEST~     follow-up schedule. This is roughly the same visit schedule for people with TB who are~     usually seen more frequently than those without TB, whether or not the patients join this~     sub-study. The 2 week visit is specifically so the investigators can make sure participants~     are doing OK on rifabutin and to check carefully that they don't have any side-effects. At~     all these visits (including the day when participants enroll into the substudy) the~     investigators will take an extra 10 ml (two teaspoons) of blood to do laboratory tests for~     side-effects of rifabutin, and to measure the levels of rifabutin and other ARVs in the~     blood - these are called pharmacokinetic or PK studies. On the day of these visits,~     participants should not take their dose of rifabutin until after this blood draw, so the~     investigators can measure the lowest amount of drug likely in their blood. Instead,~     participants should bring the rifabutin dose to clinic, so that they can take it straight~     after the blood draw. At the visit 12 weeks after starting rifabutin, participants will need~     to stay in clinic for a second blood draw of ~3 ml (half a teaspoon) around 4 hours after~     they take the rifabutin dose immediately after the first blood draw. We use this second~     sample to see how quickly rifabutin enters the blood. At this special visit the~     investigators will make sure participants are first seen as early as possible, so they don't~     have to stay any longer than necessary for the second blood draw to be taken 4 hours later.~     After participants have completed their TB treatment they will stay in EARNEST until the end~     of the trial (144 weeks on second-line therapy).~      - What are the possible benefits and risks of participating?~      If participants are allocated to Group 1 (150 mg rifabutin three times a week), there is a~     risk that they may have lower levels of rifabutin in your blood and this may be less~     effective at treating the TB. However, participants should have fewer side-effects. In~     contrast, if participants are allocated to Group 2 (150 mg rifabutin daily), here is a risk~     that they may get more side-effects, but the levels of rifabutin in the blood should be more~     than high enough to have a good chance of curing the TB. Having blood taken may cause some~     discomfort and/or bruising in some people. It is currently impossible to know which~     rifabutin regimen would be best and participants may find in years to come that they may or~     may not have received the best treatment.~        -  Where is the study run from?~           9 EARNEST sites in Uganda as follows: JCRC Kampala, IDI, San Raphael of St Francis~          Hospital (Nsambya), JCRC Mbarara, JCRC Mbale, JCRC Kabale, JCRC Kakira, JCRC Gulu~        -  When is study starting and how long is it expected to run?~      Start 05/03/2012 finish on 31/01/2014~      - Who is funding the study? Abbott~   "
106485|NCT01663155|"~     The investigators would like to see if lung cancer screening with chest x-rays,computer~     aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it~     is more responsive to treatment. The investigators would also like to see if early detection~     will reduce the incidence of symptomatic advanced lung cancer compared to no screening in~     former and current smokers with or without a family history of lung cancer who are 40-75~     years old.~   "
106486|NCT01663142|"~     Crohn's disease is a disease of complex etiology, multifactorial and still poorly~     understood. This disease, due to its morbidity and mortality, poses a significant public~     health problem in France. Apart from the involvement of bacterial factors and those~     involving the permeability of the epithelial barrier, it is now well recognized that several~     factors are associated with genetic predisposition in some of these patients. Among these~     factors, the Nod2 mutations were first identified. Studies concerning the presence of these~     mutations and the severity of disease results were sometimes conflicting. Very recently, new~     interesting mutations in genes involved in autophagy were found with greater frequency in~     patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been~     particularly shown on large patient cohorts,the IRGM polymorphism was associated with a~     progressive disease, with histological severity scores. One of the severity criteria of~     Crohn's disease is the early recurrence observed in some patients after surgical resection~     of the injured segment. Predictive factors for such recurrence after surgery are not known~     or not.~   "
106487|NCT01663129|"~     To determine the magnitude and rate of bone mass deficits following initiation of~     glucocorticoid therapy for the treatment of pediatric leukemia, rheumatic conditions and~     nephrotic syndrome, we propose a 6 year, prospective study in 12 academic, tertiary care~     centres across Canada.~      The investigators hypothesize that glucocorticoid-treated children with leukemia, rheumatic~     conditions and nephrotic syndrome will fail to accrue bone mass at a normal rate, and that~     deficits in mineral accrual will occur in a glucocorticoid dose- and duration-dependent~     fashion. We also hypothesize that the fracture incidence will increase with concomitant~     reductions in bone mass.~   "
106488|NCT01663116|"~     Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class~     (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with~     three treatment groups, controlled with placebo (randomization 3:1) whose target population~     are patients with rheumatoid arthritis refractory to at least two biologic.~   "
106489|NCT01663103|"~     Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic~     kidney disease (CKD); however, this increased risk is only partially explained by~     traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a~     key mechanism contributing to vascular dysfunction (i.e., large elastic artery stiffening~     and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other~     populations characterized by chronic inflammation. However, it is currently unknown if~     reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD~     patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating~     vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration~     rate 15-60 mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also~     reduces inflammation and oxidative stress. These studies could shift clinical practice~     guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not~     requiring chronic hemodialysis.~   "
106490|NCT01663090|"~     This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the~     purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast~     agent is an investigational drug. Investigational means that the drug is still being~     studied and that research doctors are trying to find out more about it. It also means that~     the FDA has not approved ferumoxytol for this use. This drug has been used to image adults~     with other forms of cancer, however, it has only been used to image a small number of~     pediatric patients. Ferumoxytol has never been used to image sarcoma.~   "
106512|NCT01662804|"~     The purpose of this study is to find out if humanized 3F8 (Hu3F8) when combined with~     interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study~     means the investigators are trying to find out what side effects happen when higher and~     higher doses of a drug are used.~      The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2~     has on cancer. The amount of Hu3F8 that patients gets will depend on when they start~     treatment on this study. The amount of rIL2 will be the same for all patients. The~     investigators also want to find out more about how Hu3F8 works and how effective it is in~     attacking the disease when combined with rIL2.~   "
106553|NCT01662401|"~     After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in~     the postoperative period. As a routine part of the procedure, surgeons inject local~     anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most~     children will still require additional pain medications after surgery. The purpose of the~     study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal~     nerve) will give better pain relief, decreasing pain medication requirements and increasing~     comfort during the postoperative period.~   "
106491|NCT01663077|"~     Approximately 30-60% of all schizophrenia patients who fail to respond to typical~     antipsychotics may respond to Clozapine. Clozapine has long been considered the gold~     standard within the atypical neuroleptic spectrum, backed by years of clinical experience~     and research, but uncertainties remain in some aspects of this drug. One such question is~     the link between dose, blood levels and patient clinical response. The Clozapine therapeutic~     plasma levels range between 250 - 450 ng/mL creating difficulties in using these results in~     routine clinical practice. Approximately 30% - 51% of treatment-resistant schizophrenia~     patients do not fully respond to Clozapine, a poorly understood phenomenon. Factors relevant~     to Clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate~     duration of treatment and inadequate dose/plasma-levels. Pharmacogenetic factors such as~     different polymorphisms in involved genes may play a role. Pharmacodynamic and genetic data~     appear important in determining the clinical response to Clozapine. Clozapine-treated~     patients possessing different 3A4 polymorphisms, may respond differently as compared to~     other patients having normal 3A4 alleles. Recently, the CYP2D6 has also been involved in~     this drug metabolic pathway. Population pharmacokinetics of clozapine evaluated with the~     nonparametric maximum likelihood method. This pharmacogenetic explanation/hypothesis may~     explain Clozapine- resistance in schizophrenics.~      The high variability in plasma levels requires a large study in order to be able to~     determine correlation between clinical efficacy and plasma levels and genotyping. A~     preliminary study will enable power analysis and adequate determination of sample size.~   "
106492|NCT01663064|"~     The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish~     Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the~     treatment of abdominal aortic aneurysms.~   "
106493|NCT01663051|"~     This prospective, non-randomized, multi-center study is intended to evaluate the Zilver®~     Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.~   "
106494|NCT01663038|"~     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and~     separate combination of clopidogrel 75mg/aspirin 100mg.~   "
106495|NCT01663025|"~     This randomised controlled trial aims to compare the effectiveness of hand reflexology~     received during office based vein surgery, under local anaesthetic on patient's reports of~     pain and anxiety, compared to usual standard care.~   "
106496|NCT01663012|"~     High Grade Gliomas, including anaplastic astrocytomas, anaplastic oligodendrogliomas and~     glioblastomas (GBM), are the most common and most aggressive primary brain tumors. Prognosis~     for patients with high-grade gliomas remains poor. The estimated median survival for~     patients with GBM is between 12 to 18 months. Recurrence after initial therapy with~     temozolomide and radiation is nearly universal. Since May 2009, the majority of patients in~     the US with an initial recurrence of high-grade glioma receive bevacizumab, a monoclonal~     antibody against vascular endothelial growth factor (VEGF), which is thought to prevent~     angiogenesis in these highly vascular tumors. BEV has response rates from 32-62% and has~     improved overall median survival in patients with recurrent high-grade gliomas1. However,~     the response is short lived, and nearly 100% of patients eventually progress despite~     bevacizumab. No chemotherapeutic agent administered following progression through~     bevacizumab has made a significant impact on survival. Patients progress to death within 1-5~     months after resistance develops. Therefore, patients with high-grade gliomas who have~     progressed through bevacizumab represent a population in dire need of a feasible and~     tolerable treatment.~      NKTR-102 is a topoisomerase I inhibitor polymer conjugate that was engineered by attaching~     irinotecan molecules to a polyethylene glycol (PEG) polymer using a biodegradable linker.~     Irinotecan released from NKTR-102 following administration is further metabolized to the~     active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38), that causes DNA damage through~     inhibition of topoisomerase. The goal in designing NKTR-102 was to attenuate or eliminate~     some of the limiting side effects of irinotecan while improving efficacy by modifying the~     distribution of the agent within the body. The size and structure of NKTR-102 results in~     marked alteration in pharmacokinetic (PK) profile for the SN38 derived from NKTR-102~     compared to that following irinotecan: the maximal plasma concentration (Cmax) is reduced 5-~     to 10-fold and the half-life (t1/2 ) of SN38 is increased from 2 days to approximately 50~     days. This altered profile leads to constant exposure of the tumor to the active drug. In~     addition, the large NKTR-102 molecule does not freely pass out of intact vasculature, which~     may account for relatively higher concentrations of the compound and the active metabolites~     in tumor tissues in in vivo models, where the local vasculature may be relatively more~     permeable. A 145 mg/m2 dose of NKTR-102, the dose intended for use in this phase II clinical~     trial (and being used in the phase III clinical program), results in approximately the same~     plasma exposure to SN38 as a 350 mg/m2 dose of irinotecan, but exposure is protracted,~     resulting in continuous exposure between dosing cycles and lower Cmax. NKTR-102 was~     therefore developed as a new chemotherapeutic agent that may improve the clinical outcomes~     of patients.~   "
106497|NCT01662999|"~     The purpose of this study is to evaluate whether the pharmacokinetics (body~     concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when~     they are administered together~   "
106498|NCT01662986|"~     A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess~     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in~     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an~     acute exacerbation (Hospital Discharge Study 2)~   "
106499|NCT01662973|"~     Primary biliary cirrhosis (PBC) is a slowly progressive disease that causes substantial loss~     of intrahepatic bile ducts, ultimately resulting in cholestasis, advanced fibrosis,~     cirrhosis, liver failure and even hepatocellular carcinoma. Histologically, the disease is~     characterized by chronic portal inflammation with infiltration, destruction and loss of the~     epithelial cells in the small-sized and medium-sized bile ducts. Currently, Ursodeoxycholic~     acid (UDCA) in a dose of 13-15mg/kg/day is recommended as therapeutic drugs for PBC by AASLD~     and is approved for this indication by the U.S. Food and Drug Administration (FDA).~     Treatment with UDCA may delay disease progression and prolong survival free of liver~     transplantation. However, one out of three patients does not adequately respond to UDCA~     therapy and many need additional medical therapy or liver transplantation, or both. UC-MSC~     has been application for the treatment of several severe autoimmune diseases, such as immune~     thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis.~     In this study, the safety and efficacy of UC-MSC transplantation for PBC patients will be~     evaluated.~   "
106500|NCT01662960|"~     The purpose of the study is to determine whether an existing treatment for problems that~     participants have with making movements after a stroke can be performed at home.~   "
106501|NCT01662947|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the efficiency of device.~        2. Test methods and procedures: Clinical test in two positions: Seated and Supine.~        3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.~        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and~          range: 0-300 mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
106502|NCT01662934|"~     The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy~     machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.~   "
106503|NCT01662921|"~     We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting~     insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with~     gestational diabetes mellitus.~   "
106504|NCT01662908|"~     Assess the relative change in thrombus volume as determined by two assessments (Baseline and~     Day 14-21) with magnetic resonance imaging (MRI) in subjects with deep-vein thrombosis (DVT)~     treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW)~     heparin/warfarin regimen.~   "
106505|NCT01662895|"~     The main purpose of this study is to determine whether treatment with deferoxamine mesylate~     is of sufficient promise to improve outcome before pursuing a larger clinical trial to~     examine its effectiveness as a treatment for brain hemorrhage.~   "
106506|NCT01662882|"~     Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing~     Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or~     Mild cognitive impairment (MCI).~   "
106554|NCT01662388|"~     Several techniques have been advocated to get good contacts in dental composite restorations~     including interdental separation ring. The investigators study focuses on using separation~     ring with circumferential matrix band instead of a sectional band. Moreover, the~     investigators have attempted to study proximal tightness and proximal contours of composite~     restoration as separate variables~   "
106513|NCT01662791|"~     The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in~     patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was~     that SBBO is an important contributor to the development of weight loss in individuals with~     PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in~     patients with PD and 2) determine the response to its treatment with a poorly absorbed~     antibiotic. The investigators performed a prospective, observational case-control study~     (Part 1) with an open-label therapeutic component (Part 2). Cases were defined as those PD~     patients who experienced significant weight loss while Controls were defined as those PD~     patients who did not experience significant weight loss.~   "
106514|NCT01662778|"~     The objective here is to determine that the efficiency of inhaled drug delivery can be~     improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of~     drug particles). This information will be valuable in designing new inhalers in order to~     improve their beneficial effects and reduce their side effects, by using the least possible~     drug dose to achieve a good patient response.~   "
106515|NCT01662765|"~     The aim of the study was to compare the results of conservative and surgical treatment, to~     create an algorithm for the management of the disease, and gain more information about the~     etiology, pathogenesis, and course of the disease. The investigators hypothesise that~     surgical treatment of UPS will be better than conservative management in terms of recurrence~     rate, healing time, patient comfort and satisfaction, and cost effectiveness.~   "
106516|NCT01662752|"~     The main objective of this study is to determine whether the first (sentinel) lymph nodes in~     the drainage pathway of colonic tumour can be detected at the time of surgery using a new~     technique. The detection method is to inject a fluorescent dye (indocyanine green) adjacent~     to the tumour. The dye will then be seen as it fluoresces in the light form the near~     infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An~     endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent~     agent is injected around the tumour. The mesentery in which the lymph nodes draining the~     tumour are located will then be examined by laparoscopy as it is expected that fluorescence~     will be identified within approximately 5 minutes of the injection. The first lymph node or~     nodes that take up the fluorescent dye will then be marked by placing a clip or a stitch by~     them. After the surgery has been completed and colon removed all lymph nodes can be examined~     microscopically by the pathologist, paying a particular attention to whether any tumour~     cells are present in the sentinel lymph nodes and whether the presence or the absence of~     tumour cells in that node accurately reflects the tumour status of the rest of the specimen.~      If this pilot demonstrates that sentinel lymph nodes can be reliably detected, we have~     developed a technique which allows us to remove a small area (less than 5 cm) of the colon.~     Using this procedure should decrease complications following traditional surgery. We however~     also need a method that allows accurate assessment of the lymph nodes draining the tumour.~     This pilot trial will examine our ability to detect such 'sentinel' lymph nodes so that we~     can use their status (positive for cancer cells or negative) to determine whether a smaller~     operation such as full thickness localised excision is adequate treatment for the patient~     and that they can avoid a larger operation.~   "
106517|NCT01662739|"~     Gastric cancer remains one of the leading causes of cancer-related deaths worldwide. There~     is difference between different countries in the world in the incidence and outcome. Also~     Italy on its inside shows a variability between regions and Lombardy hold the most incidence~     and mortality Italian rate, with the province of Cremona as one of the leading area with its~     gastric cancer mortality rate. (http://www.aslcremona.it/html/atlante/introduzione.htm).~     Tumor specialized registry can be viewed as one of the main strategies for studying and~     monitoring the impact of an important cancer diagnosis. In addition the information obtained~     from it can be translated into preventive measures and health surveillance that might lead~     to a better control of this tumor in a province with a so high mortality rate. Project~     purpose is to define the incidence of gastric cancer in the province of Cremona and the~     correlation with environmental, familiar, genetic and social factors; to adopt prevention~     strategies to reduce the impact of the disease and to create a gastric cancer bio-bank,~     including blood and tissue samples, for collaborative research projects regarding molecular~     and cellular aspects of gastric cancer.~   "
106518|NCT01662726|"~     This study is investigating the effects of a new hormone treatment for breast cancer called~     Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to~     grow therefore are likely to respond to hormone therapy. Irosustat blocks a different~     pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the~     body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing~     altogether.~      IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast~     cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on~     breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a~     radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT~     scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This~     type of scan can show how body tissues are working, as well as what they look like. FLT-PET~     scans will be performed before and following treatment with Irosustat. As cancer cells grow~     faster than the normal cells around them, they will take up more of the radioactive~     substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer~     growth, the cancer will take up less of the tracer.~      Blood samples will be taken at regular intervals to assess what the new drug does to the~     body and the safety and tolerability of Irosustat will be assessed. The study incorporates~     translation aspects/endpoints which are based on the collection of tumour biopsies before~     and after treatment with Irosustat although the later biopsy is not mandatory.~   "
106519|NCT01662713|"~     The purpose of this research study is to find out if a non-invasive imaging device called~     Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels~     that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details~     of your skin without needing to use any invasive techniques such as surgery or biopsy.~   "
106530|NCT01662570|"~     The rise in childhood overweightness and concomitant increase in chronic disease risk~     warrants exploration into the effectiveness of interventions targeting the eating and~     activity habits of overweight youth. This research study developed and tested a Beverage~     Choice and Lifestyle Modification (BCLM) intervention for 4 to 8 year old children who are~     at-risk for being overweight or are overweight and who consume large amounts of sugar~     sweetened beverages and juice. The overall study objectives were to test the acceptability~     and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)~     intake, beverage selections and beverage preferences of children in targeted age and BMI~     group. The investigators hypothesized that those children randomized to the BCLM group will~     show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and~     energy intake than those assigned to our Nutrition Education (NE) group.~   "
106520|NCT01662700|"~     In Thailand, the proportion of P.vivax infection has now been increasing and is equal to~     Plasmodium falciparum since 1998. The incidence of P.vivax has recently been reported as 20~     per 1000 population per year. Unlike Plasmodium falciparum, P.vivax infection rarely~     develops into complicated malaria and death is unusual. However, P.vivax has a dormant stage~     (the hypnozoite) that persists in the human liver and may cause relapse weeks, months, or~     even years later. Therefore, P.vivax infection is considered to have greater impact on~     morbidity than mortality, resulting in significant social and economic burden. Moreover, it~     is very difficult to control P.vivax transmission, because gametocytes appear almost~     simultaneously with schizonts.~      Radical treatment of the infection, therefore, normally consists of a blood schizontocidal~     course of chloroquine and a course primaquine for the elimination of the hypnozoites as~     anti-relapse therapy. In Thailand, chloroquine and primaquine have remained the mainstay~     chemotherapeutics for the treatment of P.vivax for more than 60 years and resistance has not~     yet been reported . The relapse rates at day 28 are about 50% without primaquine therapy and~     about 20% with standard primaquine therapy. Relapse has not been observed among patients~     receiving high dose primaquine therapy (30 mg daily for 14 days).~      Since January 2007, the evidence of reduced susceptibility of Plasmodium falciparum to~     artemisinins in Western Cambodia at Thai-Cambodia border was first presented and confirmed~     in a subsequent detailed pharmacokinetic-pharmacodynamic study. Nevertheless, a trend of~     gradual decline of in vitro sensitivity to chloroquine has been documented in some areas of~     the country, particularly Thai-Myanmar border. There has been no clinical-parasitological~     evidence of chloroquine resistant P.vivax in Thai-Cambodia border, Thailand.~      The objectives of the present study are to assess in vivo efficacy of first line regimen of~     chloroquine given with primaquine, and in vitro susceptibility of P.vivax isolates in areas~     along Thai-Cambodia border, Thailand.~   "
106521|NCT01662687|"~     Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is~     to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS)~     compared with the intravenous and oral Granisetron in the prevention of CINV associated with~     moderately emetogenic Chemotherapy.~      Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for~     1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy.~     Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit~     (1 to 2 days prior to ME chemotherapy).~        -  Sancuso patch~        -  Kytril inj.+Kytril tab.~      The patch will be applied 2days (48-24h) prior to first daily dose of the moderately~     emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed~     daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be~     collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up~     until 14 days after the final dose of IP. Serious adverse events will be followed-up until~     they are resolved, stable or until the patient is lost to follow-up.~   "
106522|NCT01662674|"~     This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of~     the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison~     to each component administered in healthy male volunteers.~   "
106523|NCT01662661|"~     The purpose of this study is to assess the relative bioavailability (the degree to which the~     study medication becomes available in the blood circulation) of JNJ-47910382, given as an~     uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult~     participants under fed conditions.~   "
106524|NCT01662648|"~     The purpose of this study is to explore the efficacy of flexibly dosed paliperidone~     extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms~     of emotional instability, detachment from reality, often with delusions and hallucinations,~     and withdrawal into the self) who were previously unsuccessfully treated with other oral~     antipsychotics.~   "
106525|NCT01662635|"~     Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is~     critically important to select those patients who are more likely to have the ALK mutation.~     Clinical characteristics of patients with mutations in the target gene should also be known,~     so that the incidence of a given target mutation is established in a specific population.~     There is not incidence known in Mexican population, but it is believed it is greater.~   "
106526|NCT01662622|"~     Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to~     investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC~     of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects~     (MACie) in middle aged subjects.~   "
106527|NCT01662609|"~     The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect~     early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for~     the development of pancreatic cancer. Endoscopic refers to the use of an instrument called~     an endoscope - a thin, flexible tube with a tiny video camera and light on the end.~     Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in~     this research study is a method of combining endoscopy and ultrasound imaging to obtain high~     quality images of the pancreas.~   "
106528|NCT01662596|"~     The purpose of the study is to estimate the rate of risk factors for appearance of disease~     or fetal malformations in a population who turn to hospital Hillel Yaffe and examine~     whether there is a difference in the rate of early testing for diseases or birth defects in~     the fetus.~      Understanding the population and its risk factors, will allow specific reference to these~     risk factors to lowering them to eventually reduce the rate of congenital malformations in~     this population.~   "
106529|NCT01662583|"~     Influenza remains a potentially significant and largely preventable source of morbidity and~     mortality, yet vaccine coverage is low. Young children are at particular risk for~     underimmunization because they may need to receive 2 doses in a current season. Even among~     those young children that initiate vaccination, only 40% receive the important second dose,~     yet one dose does not confer adequate protection. Low-income, urban children may be at~     particular risk of not receiving two doses. While traditional mail and phone immunization~     reminders notifying families that a vaccine is due have had limited efficacy in low-income,~     urban populations, we have demonstrated the success of using text messages. Comparing the~     effectiveness of different forms of reminders on receipt of this critical second dose of~     influenza vaccine has not been studied. Besides failure to remember to return for subsequent~     doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health~     literacy regarding influenza vaccination, particularly associated with understanding the~     need for a second dose since not all children require it. Text messaging offers the ability~     to combine health literacy promoting information and reminders in a scalable, efficient~     manner for populations at high risk for underimmunization, limited health literacy, and~     influenza spread. Therefore, the purpose of this study is to determine whether the provision~     of interactive vaccine health literacy-promoting information in text message vaccine~     reminders improves receipt and timeliness of the second dose of influenza vaccine within a~     season for underserved children in need of two doses.~   "
106531|NCT01662557|"~     Childhood overweight continues to increase at an alarming rate and the need exists to find~     effective, accessible intervention strategies to prevent and treat children who are at risk~     for being overweight or are already overweight. The primary care setting provides an~     attractive option for families wishing to receive treatment, yet little is known about the~     feasibility, acceptance or efficacy of this intervention setting. The purpose of this study~     was to test two different primary care treatments that were intended to increase fruit and~     vegetable intake, increase physical activity, and reduce sedentary activity in children ages~     4-8, who are overweight or at risk for becoming overweight. Both treatments involved the~     child and a parent/caregiver and both were conducted over a four month period. The~     parent/child dyads were selected from the pool of families who receive their primary care~     within the Geisinger Medical Center geographic area and who have been identified by their~     pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile~     for age). One group received weekly mailings which focused on healthy eating, promotion of~     fruit and vegetable intake and physical activity, and methods to reduce TV viewing time. The~     second group received a group-based intervention at one of the Geisinger Pediatric Clinic~     sites using specific behavioral strategies for increasing fruit and vegetable intake,~     reducing TV viewing and encouraging physical activity. Changes in overweight percentage,~     child BMI, lipid profile, glucose/insulin levels, and anthropometric measurements were~     analyzed, as well as treatment satisfaction and acceptance. The investigators hypothesized~     that children who receive Family Behavior Modification (FBM) in the primary care setting~     will show greater reductions in Body Mass Index (BMI), BMI z-score, percent overweight and~     waist circumference, and that children receiving FBM will show greater improvements in~     dietary intake, increased physical activity, reduced sedentary activity, and improvements in~     cardiovascular outcomes.~   "
106532|NCT01662544|"~     Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and~     children. Multiple supportive therapies have been tried in infants with bronchiolitis~     including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date~     supportive therapy with oxygen is the only proven therapy to decrease respiratory distress~     in infants with bronchiolitis, with hypertonic saline showing a borderline statistically~     significant improvement. This prospective, randomized study will compare CSS and PEWS scores~     on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen~     via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants~     with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have~     improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and~     ultimately decreased lengths of admissions when compared to patients treated with nasal~     cannula oxygen therapy with/without bronchodilator therapy.~      Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases~     respiratory distress as measured by pediatric CSS and PEWS when compared with routine nasal~     cannula oxygen delivery in infants with bronchiolitis.~   "
106533|NCT01662531|"~     This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control~     and prevention of bleeding episodes in children who have previously received factor~     replacement therapy for hemophilia B.~   "
106534|NCT01662518|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.~   "
106535|NCT01662505|"~     To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese~     patients with AML~   "
106536|NCT01662492|"~     To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)~     as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.~   "
106537|NCT01661426|"~     The traditional weight loss diet recommended by health professionals has been a low-fat,~     high-carbohydrate, calorie restricted diet. This recommendation has been challenged by a~     number of alternative dietary strategies, particularly low-carbohydrate diets. In several~     recent weight loss studies insulin resistant adults had more success with low- vs.~     high-carbohydrate diets, in contrast to insulin sensitive adults who had either more success~     or comparable success with the low-fat diets. The investigators plan to enroll 80 people~     with a wide range of insulin sensitivity/resistance. After determining their insulin~     resistance status, the investigators will split them in the middle and randomly assign them~     to one of four groups: (1) Low-Carbohydrate/Insulin Resistant (LC/IR); (2)~     Low-Carbohydrate/Insulin Sensitive (LC/IS); (3) Low-Fat/Insulin Resistant (LF/IR); and (4)~     Low-Fat/Insulin Sensitive (LF/IS) (20 people/group). The purpose of this study is to~     determine whether weight loss success can be increased if one follows the dietary approach~     appropriately matched to their insulin resistance status.~   "
106538|NCT01661413|"~     Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.~     Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during~     treatment reported by paediatric cancer survivors. Complete prevention of both nausea and~     vomiting is the goal of anti-vomiting and nausea medications. It is important to understand~     whether or not certain chemotherapeutic treatments are more or less likely to cause these~     symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal~     methotrexate is an important part of chemotherapy for the prevention and treatment of~     central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for~     leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will~     cause nausea and vomiting has not yet been described in children. Knowledge of the~     likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be~     important to optimize treatment for these side-effects of chemotherapy. The primary aim of~     this prospective study is to evaluate the potential of intrathecal methotrexate to cause~     nausea and vomiting in paediatric cancer patients.~   "
106539|NCT01661400|"~     The purpose of this research study is to determine whether taking either of two low dose~     drugs that would prevent new blood vessels from growing after stem cell transplant is~     feasible, and what the side effects of taking each of these drugs after autologous~     transplant might be. The reason the investigators are looking at these drugs is because one~     of the things that allows tumors to grow quickly is their ability to stimulate the growth of~     new blood vessels. By suppressing the growth of new blood vessels after stem cell~     transplant, the investigators hope to prevent the tumors from coming back or continuing to~     grow.~   "
106540|NCT01661387|"~     As a post-approval requirement of the European Medicines Agency, this European patient post~     authorization safety study is an observational study being conducted to monitor the safety~     of long-term treatment with Plenadren and other glucocorticoid replacement therapies in~     routine clinical practice in patients with chronic adrenal insufficiency (primary or~     secondary).~   "
106541|NCT01661374|"~     In this study the investigators will collect mucus from mechanical ventilated patients and~     patients with COPD to study the effect of temperature and humidity, on the biophysical~     properties of the airway mucus. It is hypothesised that changes in inspired gas temperature~     and humidity (over time) may affect the biophysical properties of the airway mucus and~     reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.~   "
106542|NCT01661361|"~     Recently, it was reported that when vancomycin levels are determined after port sampling,~     levels can be falsely increased potentially leading to wrong dose adjustments.~      The investigators conducted an in vitro experiment using several central venous port~     devices, in which different flushing techniques were evaluated yielding residual vancomycin~     levels of less than 0.5 mg/L.~      In this study, the investigators want to evaluate this flushing technique in vivo in 15~     patients admitted with catheter-related infection and treated with systemic vancomycin and~     vancomycin antibiotic lock.~      The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained~     via port sampling.~   "
106543|NCT01661348|"~     Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing~     postoperative surgical site infections in the obese parturient undergoing non-emergent~     cesarean delivery.~      Aim 2: Assess patient satisfaction after using the Prevena Incision Management System~     following a non-emergent cesarean delivery.~      Our overall long term goal is to reduce morbidity and incidence of surgical site infection~     (SSI) in obese parturient who undergo non-emergent cesarean delivery.~   "
106544|NCT01661335|"~     The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the~     standard therapy will help children who receive chemotherapy to have less nausea and~     vomiting.~   "
106545|NCT01661322|"~     The risk of recurrence is greatest immediately after stroke or Transient Ischaemic Attack~     (TIA). Existing prevention strategies (antithrombotic, lipid/blood pressure lowering,~     endarterectomy) reduce, not abolish, further events. Dual antiplatelet therapy - aspirin &~     clopidogrel (AC) for IHD, aspirin & dipyridamole (AD) for stroke, is superior to aspirin~     monotherapy. The investigators hypothesise that triple antiplatelet therapy (ACD) will be~     superior to AD in patients at high-risk of recurrence, providing bleeding does not become~     excessive.~      Design: TARDIS is a multicentre, parallel-group, prospective, randomised, open-label,~     blinded-endpoint, controlled trial. In the start-up phase, the investigators will assess~     over 3 years the safety, tolerability and feasibility of intensive therapy (ACD) versus~     guideline therapy (AD) given for 1 month in 750 patients with acute stroke/TIA. The main~     phase will then assess the safety and efficacy of ACD in up to 3500 patients. The primary~     outcome is ordinal stroke (fatal/severe non-fatal/mild/TIA/none) at 90 days. Secondary~     outcomes include death, MI, vascular events, function, bleeding, serious adverse events;~     sub-studies will assess cerebral emboli and platelet function.~   "
106546|NCT01661309|"~     Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary~     animal produce, which can elevate homocysteine. There is strong evidence indicating that~     elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as~     primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant~     decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin~     B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.~   "
106547|NCT01661296|"~     Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML)~     and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis,~     and approximately 2 million new cases occur annually, making it a major global health~     problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar~     Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium~     stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient~     compliance as they require multiple intramuscular or intralesional injections for 3 weeks.~     In addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are~     interested in novel treatments for CL that are safe, easy to administer and effective in~     inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used~     to treat CL. This treatment involves the controlled and localized delivery of~     radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term~     follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study~     involving US soldiers who were infected with L. major in Iraq found that RFH therapy was~     comparable, or even better, than systemic antimonials. However, more studies are needed to~     establish long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania~     species that are difficult to treat with conventional drugs, and to determine the risk of~     disease recurrence if any in patients living in Leishmania endemic regions. The goal of this~     trial is to compare long term efficacy of RFH therapy in treatment of CL caused by L.~     tropica in patients residing in Leishmania-endemic regions of India.~   "
106548|NCT01662466|"~     The purpose of this study is to determine the effect of treatment with trans-dermal~     testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo~     quality, and pregnancy rates among women with evidence of diminished ovarian reserve that~     have persistently low serum testosterone and free testosterone after completing six previous~     weeks of DHEA supplementation.~   "
106549|NCT01662453|"~     The main purpose of this study is to develop a North American registry for SUDEP cases;~     requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP)~     to contact the study team. The family members who decide to participate in the study will be~     asked to complete a brief telephone interview about their loved one's epilepsy and seizure~     history and the circumstances of his or her death. If the death has occurred within the past~     24 hours, and the family is willing to consider donating tissue to the study, the subject~     will be transferred to the Autism Tissue Program, and the remainder of the phone interview~     will be conducted at a later time.~      In addition to the phone interview, the family will be asked to provide access to the~     deceased's medical records. Any costs involved in obtaining medical records will be covered~     by the study, and all medical information will remain completely confidential.~   "
106550|NCT01662440|"~     Establish non-inferiority of the immune response and evaluate the safety and tolerability of~     Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to~     either of 2 schedules for preexposure prophylaxis.~   "
106551|NCT01662427|"~     To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in~     Parkinson's disease patients and caregivers.~   "
106552|NCT01662414|"~     This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus~     placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's~     Disease.~      The principal objective is to evaluate the changes in biomarkers of oxidative stress~     and,plasma amino acids, as well as improvement of clinical symptoms and brain function~   "
106555|NCT01662375|"~     The Maastricht III procedure consists of performing organ donation in patients in whom~     cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is~     not applied in France, in contrast with other industrialized countries.The proposed study is~     designed to evaluate the feasibility of adapting the MIII procedure in France by conducting~     a single-centre, prospective study. Within the population of patients admitted to the Nantes~     University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to~     withdraw life support, the investigators want to determine the delay elapsed between the~     life support withdrawing and the onset of spontaneous cardiac arrest, that is without any~     intentional procedure susceptible of precipitate the death onset. The cardiovascular state~     observed during this period and its duration determine the viability of the organs~     harvested. The invetigators also want to determine the incidence of refusal of organ~     donation that would be formulated by the family and/or loved ones if they had been asked to~     consent to an MIII procedure at the time of announcement of the clinical team's decision to~     withdraw life support.Anonymous data concerning the patient will be collected by using a~     predefined grid, completed partly by the medical team in charge of the patient and partly by~     a CRA from data in the patient's medical file.The study with families and/or loved ones will~     be conducted in the context of the CHU de NANTES Clinical Ethics Unit and according to this~     unit's methodology. The main working tool used by the Clinical Ethics Unit consists of~     interviews between its members and the various parties participating in elaboration of a~     decision (in this case, the virtual possibility of organ donation according to the MIII~     procedure).The purpose of this interview is to stimulate reflection on issues not previously~     considered, by introducing new elements and by using, as a tool, the principles of~     biomedical ethics developed by Beauchamps and Childress. This study should be able to~     determine which types of patients could be concerned by the Maastricht III procedure. The~     expected results should help to define the quantitative impact and feasibility of this~     procedure on organ donation and could be used to subsequently propose a larger-scale~     multicenter prospective study.~   "
106556|NCT01662362|"~     The study is conducted to meet an FDA post market commitment to collect and report data on~     the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are~     FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA~     Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified~     donor specimens will be tested with ABBOTT ESA Chagas assay.~   "
106557|NCT01662349|"~     The purpose of this study is to evaluate the safety of treating human skin with atmospheric~     plasma and get an initial evaluation of the efficacy of this treatment for acne.~   "
106558|NCT01662336|"~     The study will assess the effectiveness of KASA (Kaletra Patient Support Program) on~     improving or maintaining treatment adherence in HIV positive patients that have been~     initiated on treatment with Kaletra®. This will be a purely observational study conducted on~     patients that will be on treatment with Kaletra®. All treatments will be as per routine care~     including the use of KASA which will be determined exclusively by the physician and the~     patient without consideration of the study.~      The efficacy of disease management programs as assessed in randomized clinical trials is not~     representative of real - life effectiveness observed under routine clinical practice. In~     real - life settings the utilization of and compliance with disease management programs by~     physicians and patients is not uniform. Therefore assessment of their true effectiveness is~     ideally conducted under a pure observational setting without any interference from the~     investigators with respect to making the programs available to patients and enforcing their~     adherence to them.~   "
106559|NCT01662323|"~     The purpose of this study is to determine whether it is possible to improve the care of~     general practitioners for patients with heart failure. The investigators try to reach that~     goal by training the GP's for 90 minutes in uptitrating the recommended medication according~     the guidelines. After 6 month the investigators ask the patients to fill out a questionary.~     The investigators ask them about their quality of live.~   "
106560|NCT01662310|"~     The purpose of this study is to evaluate the efficacy, tolerability and safety of~     paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in~     the prevention of relapse in schizophrenia participants.~   "
106561|NCT01662297|"~     This is a pilot comparative effectiveness study designed to determine whether trazodone is~     as effective as quetiapine for treatment of insomnia in veterans with a history of addiction~     and mental health issues. The study will have two concurrent phases (parts); first an~     acceptability determination phase, to determine whether and why (or why not) veterans~     already taking quetiapine are willing to try an alternative to quetiapine for sleep; and~     second, a randomized trial phase which will test whether staying on quetiapine has any~     advantage over switching to trazodone. The purpose of the first phase will be a) to document~     the proportions of patients and physicians who are willing to agree to such a switch, b) to~     characterize sociodemographic and clinical characteristics of potentially eligible subjects~     associated with a willingness to switch from quetiapine to trazodone and c) to record the~     reasons given why patients and their prescribers are (or are not) willing to accept a switch~     from quetiapine to trazodone. It will also function to provide some educational background~     to patients and a reminder to providers about the potential severe side-effects of~     quetiapine, and will thus facilitate clinical informed consent for the clinical trial phase~     of the study. Completion of the first part of the study will also serve as the screening~     component for part II. Part II includes, first, obtaining written informed consent from~     eligible subjects, and then randomly assigning them to continue quetiapine or to be switched~     to trazodone in open-label real world fashion for the duration of 4 weeks, followed by~     another four weeks of open, non-randomized follow- up. The purpose of the second part of the~     study is to determine if trazodone is an adequate substitute for quetiapine, primarily in~     terms of treating insomnia. The investigators hypothesize that trazodone will not be~     inferior to quetiapine in maintaining good quality of sleep measured by sleep scales (i.e.,~     scores will not significantly worsen once switched). This study is open to Veterans in the~     VA system only. Eligible subjects must have a history of dual diagnosis (i.e., a history~     of addiction and mental illness).~   "
106562|NCT01662284|"~     The purpose of this study is to assess the use of investigational compound 124I-NM404 for~     accurate detection and characterization of a wide variety of solid primary and metastatic~     malignancies anywhere in the body.~   "
106563|NCT01662271|"~     The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,~     psychosocial situation, and health of the affected youth. However, as few of these~     adolescents seek medical care, little is known about the longitudinal course of adolescent~     extreme obesity.~      In this study, the investigators aim to provide structured care for adolescents with obesity~     and extreme obesity over a prolonged period of time, and to gain information on the course~     of obesity and the success of different treatment options. The study is a subproject of the~     Medical and psychosocial implications of adolescent extreme obesity - acceptance and~     effects of structured care, short: Youth with Extreme obesity Study (YES), which aims at~     improving the medical care and social support structures for youth with obesity and extreme~     obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and~     24.9 years (initially up to 21 years) are eligible to participate. Participants will have a~     physical check-up every 12 months (initially every 6 months), complete questionnaires on~     their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic~     procedures to assess comorbidities. Participants are offered support and guidance for social~     and vocational integration. The study will evaluate and inform treatment and support options~     for adolescents with extreme obesity.~   "
106576|NCT01662089|"~     Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient.~     But the type of patient, efficacy, and side effect in detail of zinc supplement are not well~     characterized. The purpose of this study is to determine efficacy and side effect of~     chelated zinc in FPHL who using 5%minoxidil solution.~   "
106565|NCT01662232|"~     Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired~     endothelial function (assessed as flow-mediated dilation) represents an early marker for~     later cardiovascular events. Epidemiological and experimental studies suggest that~     consumption of tea is associated with lower progression of atherosclerosis and reduced~     cardiovascular mortality.~      Tea contains high amounts of polyphenols with important biological activities. The green tea~     catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active~     compound in vitro. However, little is known about its contribution to beneficial effects of~     tea in vivo.~      In this crossover study the impact of a single dose of EGCG applied in different forms~     (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated~     in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to~     appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG~     in cardiovascular protective effects of green tea in vivo. The outcomes will provide~     insights about the role of EGCG in different application forms to improvements of~     endothelial function in humans.~   "
106566|NCT01662219|"~     Pain and discomfort after anterior cervical spine surgery is difficult to quantify and~     quoted as moderate in severity, often needing oral opioid analgesics. In addition, these~     patients are more prone for postoperative respiratory complication due to airway edema~     secondary to surgical retraction or wound hematoma. Opioid analgesics provide good pain~     control but postoperative nausea and vomiting and respiratory depression are undesirable in~     these patients who are at risk for postoperative wound hematoma and airway edema The use of~     multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after~     ambulatory procedures at most surgery centers throughout the world . The purpose of this~     study is to determine whether superficial cervical plexus block will improve the~     postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire~     (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.~   "
106567|NCT01662206|"~     The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years,~     consuming a probiotic each day for three weeks will have improved immune strength and~     digestive health. It is hypothesized that older adults consuming the probiotics will see a~     shift in their microbiota towards the healthy bacteria resulting in a greater proportion~     of immune cells, decreased inflammation, and better digestive health.~   "
106568|NCT01662193|"~     The epidemic of type 2 diabetes is an enormous public health problem in all parts of the~     world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a~     role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory~     biomarkers are known as a new risk factor for diabetes. There is accumulating evidence~     suggesting that altered vitamin D and calcium homeostasis affect the development of type 2~     diabetes, but it is still unclear whether that effects are through reducing the level of~     adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate~     the effects of vitamin D and calcium supplementations alone and in combination on~     inflammatory biomarkers and adypocytokines in type 2 diabetic patients.~      This study is a single masked, controlled randomized trial with period of 8 weeks. 120~     diabetic patients who met the inclusion criteria will enroll in this study. Subjects will~     randomly assign in to four groups. Randomization will be achieved by permuted blocks with~     stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will~     receive 50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg~     of calcium carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of~     vitamin D3 plus 100 of mg calcium carbonate per day and group four will receive calcium and~     vitamin D placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum~     insulin, HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and~     high sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at~     the baseline and at the end of intervention. Systolic and diastolic blood pressure and~     anthropometric measurements (height, weight, hip and waist circumferences) will be measured~     at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity~     records will be taken at 2,4 and 6 week of intervention to make sure that all subjects~     maintain their usual diet and physical activity during intervention.~   "
106569|NCT01662180|"~     This large prospective multi-center cohort study aims to identify patient's characteristics~     that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU~     recombinant FSH.~   "
106570|NCT01662167|"~     The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.~   "
106571|NCT01662154|"~     Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation~     for surgery. The doctor injects local anesthetic in an appropriate area, interrupting~     signals from nerves in that area that control movement and sensation. Depending on how much~     anesthetic is injected, the doctor can impair both movement and sensation or sensation~     alone. Currently, there are a few methods used to determine how much sensation a patient has~     in an area, such as testing the patient's response to a pinprick or cold sensation on the~     skin. Unfortunately, these methods are subjective and don't always give an accurate~     measurement of how extensive the block is. For this reason, a more accurate and objective~     method of assessing nerve blocks is needed. We wish to perform a study to test two nerve~     stimulation devices to compare their ability to give adequate measurements of nerve activity~     before and after local anesthesia. If we find that a common nerve stimulator can~     consistently give accurate readings of nerve activity, anesthesiologists may be able to use~     this device to determine how well a nerve block is working and adjust the patient's~     anesthesia accordingly.~   "
106572|NCT01662141|"~     The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper~     management of severely hemodynamic compromised patients. A new ultrasound dilution method~     (COstatus) for cardiac output measurement has been developed.~   "
106573|NCT01662128|"~     Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with~     more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy~     of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental~     group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21~     days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy.~     And the control group will not receive any adjuvant therapy.Finally the investigators will~     assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of~     using medications.~   "
106574|NCT01662115|"~     The purpose of this study is to evaluate whether the use of nicotine gum in the~     postoperative period influences surgical outcome in patients undergoing colorectal surgery.~   "
106575|NCT01662102|"~     The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®~     versus maintenance treatment with Rituxan® on progression-free survival (PFS) following~     response induction with chemotherapy plus rituximab in previously untreated patients with~     follicular lymphoma.~   "
140233|NCT01219244|"~     The study will investigate whether dietary modification could provide positive effects on~     brain functions in elderly people with mild cognitive impairment.~   "
106577|NCT01662076|"~     Cancer-related fatigue has been described as a subjective feeling of physical, emotional,~     and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome~     symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the~     trajectory of their disease. Treatment interventions for cancer-related fatigue have been~     largely unsuccessful. Homeopathy involves treatment of patients with diluted natural~     substances aimed at stimulating the body's healing system. In the efficacy trial literature,~     individualized homeopathy shows the most promise over other forms of homeopathic~     intervention. Individualized homeopathic treatment involves a unique yet established method~     of case taking. During the consultation, the homeopath asks a series of broad questions to~     elicit subjective symptoms related to the patient's disease, their medical history, as well~     as particular characteristics (physical or psychological) related to the individual. This~     study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat~     their fatigue. This study hypothesizes that homeopathic treatment will effectively treat~     fatigue.~   "
106578|NCT01662063|"~     This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in~     participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)~     or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants~     will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96~     weeks.~   "
106579|NCT01662050|"~     A phase 2 study of standard R‐BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara‐c 800~     mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several~     regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma~     (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine +~     ara‐c combination had very good clinical activity, but a quite relevant hematological~     toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano~     Conference, Poster 236).~      Objectives:~      The primary objective is to determine the activity (complete remission rate according to~     Cheson 2007 criteria) and safety of age‐adjusted Rituximab‐Bendamustine‐Cytarabine (RBAC500)~     regimen at the end of treatment in older untreated patients with MCL.~      The secondary objectives are to determine:~        -  The rate of molecular response (characterized by labs of the FIL)~        -  The progression‐free survival (PFS)~        -  The overall survival (OS)~        -  The duration of responses (DOR)~        -  The rate of patients that complete the expected treatment schedule (6 courses)~        -  The rate of patients that are subject to dose reductions or delays~   "
106580|NCT01662037|"~     Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to~     investigate if Bosentan therapy can modify the outcome of children with functional single~     ventricle.~   "
106581|NCT01662024|"~     Gastric restriction is an important principle of both roux-en-Y gastric bypass and~     laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing~     System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric~     size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of~     this system has the potential to reduce the complications associated with current surgical~     approaches while effecting the desired gastric restriction. The primary objective is to~     collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery,~     Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive~     procedures.~   "
106582|NCT01662011|"~     Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that~     delivers ventilatory assist in proportion to neural effort. It was a controlled randomized~     single-center prospective study in order to explore the efficacy of this new mode of~     mechanical ventilation after corrective open-heart surgery for congenital heart disease.~   "
106583|NCT01661998|"~     The purpose of this study is to evaluate the relationship of A) The distal fusion level B)~     The total length of fusion and the post-operative range of motion in the unfused vertebral~     segments below the fusion in patients with Adolescent Idiopathic Scoliosis.~   "
106584|NCT01661985|"~     The purpose of this on-going study is to study the number of days after antibiotic treatment~     has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia~     trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative~     test result. The specimens are analyzed on first-catch-urine (men) or patient's~     self-obtained vaginal sample with quantitive nucleic acid amplification test(NAAT). A~     secondary aim is to detect macrolide resistant Mg-strains and study whether there are any~     emerging macrolide resistant Mg-strains after treatment with azithromycin. A third aim is to~     study whether the participating subjects are adherent to the study protocol meaning 12~     samples taken during a period of four weeks.~   "
106585|NCT01661972|"~     The Primary Phase I objectives are to determine the recommended phase II dose for the~     capecitabine and aflibercept doublet combination; and to describe any dose limiting and~     non-dose limiting toxicities. The Phase II Primary objective is to determine progression~     free survival associated with this regimen. The Phase II secondary objectives are to~     determine response rate associated with this regimen; to determine overall survival~     associated with this regimen; and to explore any correlation of clinical outcome with~     baseline and on treatment changes in blood-based angiogenesis biomarkers.~      This open-label, non-randomized phase I/II trial is designed to assess the safety,~     tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic~     colorectal cancer.~   "
106586|NCT01661959|"~     The purpose of this study is to analyze the long-term outcomes of surgical treatment of~     idiopathic scoliosis of all curve patterns treated by either anterior or posterior~     procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic~     scoliosis.~   "
106606|NCT01661699|"~     The purpose of this study is to check blood and urine levels to further define markers/tests~     in the blood and urine that would be useful in following patients with obstructive sleep~     apnea and then to see if by wearing CPAP every night, these markers can be reduced. This~     research is being done because currently there are no effective blood or urine markers to~     determine how well CPAP is working.~   "
106607|NCT01661686|"~     The purpose of this study is to determine whether fully covered or partially covered metal~     stents are more favorable in incurable malignant stenosis of the esophagus or cardia.~     Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia~     due to a stent or tumour related cause in a 6-month follow-up~   "
106587|NCT01661946|"~     Currently, two similar medications are available for injection into the eye to treat a~     variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab~     (Avastin). They both have a similar mechanism of action and work equally well, however only~     ranibizumab was designed for use in the eye. It is significantly more expensive per~     injection than bevacizumab (by a factor of roughly 40x).~      In published studies trends have been noted towards an increased rate of systemic side~     effects such as heart attacks and strokes. This is presumably due to absorption of the~     drug(s) from the eye into the bloodstream, however this has never been shown before. The~     purpose of the investigators study was to compare the bloodstream levels of bevacizumab and~     ranibizumab at various time points after injection into the eye. This required the creation~     of a sophisticated assay to measure blood levels of the drugs.~   "
106588|NCT01661933|"~     We have established that the hookworm Necator americanus (Na) dramatically alters the local~     and systemic immune landscape of the infected human host. Consistent with the principle of~     desensitisation, diet managed celiac disease subjects previously infected by us with Na will~     be invited to receive small incremental doses of gluten as pasta (3-25 mm straw of~     spaghetti) over 16 weeks. Each participant will then be carefully re-assessed to determine~     if it is appropriate to undertake a 12-week gluten challenge.~   "
106589|NCT01661920|"~     The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10~     days, and is determined empirically. The last North American guideline for CAP recommends~     using clinical stability criteria as a reference to establish the duration of antibiotic~     treatment, which would result in about 5 days of antibiotic use for the majority of~     pneumonia cases. In order to validate this proposal we propose to carry out a randomized~     multicenter double-blind (until the 5th day) clinical trial with adult CAP patients admitted~     to 4 hospitals in Euskadi. A control group (with routine treatment) will be compared with an~     intervention group (antibiotic treatment for at least 5 days, which will be interrupted if~     temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical~     instability is assessed), with regards to: mortality at 15 days, clinical recovery by days~     10 and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of~     antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed~     (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days,~     clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis~     for the duration of the antibiotic treatment. A total of 1100 patients will be recruited,~     following their signed consent, during the inclusion period (18 months). Stability criteria~     will be measured daily. The rest of the variables will be measured at admission and by~     telephone on days 10 and 30.~   "
106590|NCT01661907|"~     Postoperative delirium is a common complication in critically ill patients after surgery.~     Its occurrence is associated with worse outcomes of the patients. The pathophysiology of~     delirium remains poorly understood. A universal phenomenon is that delirium was frequently~     identified in elderly patients after major complicated surgery, but was rarely noted after~     minor ambulatory surgery (such as cataract surgery). This indicated that stress response~     produced by surgery might have an important role in the pathogenesis of delirium. It has~     been reported that, when compared with general anesthesia and postoperative intravenous~     analgesia, neuraxial anesthesia and analgesia reduced the occurrence of postoperative~     complications and mortality in high risk patients. Combined epidural-general anesthesia is~     frequently used in clinical practice. This anesthesia method provides advantages of both~     epidural and general anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus~     by neuraxial blockade during and after surgery, and allows patients to endure lengthy~     complicated operations without any awareness. The investigators hypothesize that combined~     epidural-general anesthesia and postoperative epidural analgesia can decrease the incidence~     of postoperative delirium and, thus, improve the prognosis of critically ill elderly~     patients undergoing major surgery. The purpose of this study is to compare the effects of~     combined epidural-general anesthesia/postoperative epidural analgesia and general~     anesthesia/postoperative intravenous analgesia on the incidence of postoperative delirium in~     elderly patients undergoing major surgery.~   "
106591|NCT01661894|"~     The primary objective is to examine the efficacy of 8-weeks of a locally developed~     brain-computer interface based system (BrainpalTM)intervention for improving attention and~     memory in normal elderly. We hypothesize that elderly who have completed the training~     program will have significant improvement in their attention and memory compared to the~     controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.~   "
106592|NCT01661881|"~     Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to~     improve upon standard of care in newly diagnosed, untreated MCL patients who were~     transplant-eligible using drugs already established as active in MCL. The combination of~     Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize~     pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with~     tolerable toxicity.~   "
106593|NCT01661868|"~     This research study is a way of gaining new knowledge about a drug called olaparib in women~     who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)~     or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with~     the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from~     repairing their DNA. In this research study, we are looking to see how well the drug~     olaparib works in women who have never received a PARP inhibitor for recurrent ovarian~     cancer as well as those who have received a prior PARP inhibitor and whose cancer has~     re-grown after receiving that PARP inhibitor.~   "
106594|NCT01661855|"~     This study will examine the potential efficacy and safety of riluzole for core and~     associated symptom domains of autism and will explore biological markers of safety and~     treatment response.~   "
106608|NCT01661673|"~     This study is being conducted to determine the safety, tolerability, pharmacokinetics, and~     effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and~     in subjects with mild cognitive impairment or early Alzheimer's disease.~   "
106668|NCT01660750|"~     This is a dose finding pilot study to evaluate the safety and determine the maximum~     tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone~     (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly~     diagnosed transplant eligible multiple myeloma.~   "
106595|NCT01661842|"~     Autoimmune hepatitis (AIH) is characterized by chronic inflammation of the liver, interface~     hepatitis, hypergammaglobulinemia, and the presence of autoantibodies. Disease presentation~     is varied but typically is based on characteristic aminotransferase elevations, histological~     abnormalities, elevated levels of serum globulins, and the presence of one or more~     autoantibodies. Two types of juvenile AIH have been identified according to seropositivity~     for smooth muscle and /or antinuclear antibody (AIH type 1) or liver kidney microsomal~     antibody (AIH type 2). Standard therapy in clinic consists of a combination of~     corticosteroids and azathioprine, which displays the efficacy in 80% of patients. However,~     7% of patients deteriorate despite compliance with the standard corticosteroid regiments~     (treatment failure),13% of patients improve but not to a degree that satisfies remission~     criteria (incomplete response), 13% of patients develop serious drug-induced complications,~     and 50%-86% of patients will relapse after drug withdrawal. These serious drawbacks~     counterbalance the benefits of conventional therapy, and they are compelling reasons to~     refine current treatment strategies and pursue alternative therapies. UC-MSC has been the~     application for the treatment of several severe autoimmune diseases, such as immune~     thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis.~     In this study, the safety and efficacy of UC-MSC transplantation for AIH patients will be~     evaluated.~   "
106596|NCT01661829|"~     In patients who underwent sphincter preserving surgery with toal mesorectal excision and~     diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators~     would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal~     function after stoma closure.~   "
106597|NCT01661816|"~     The study aims to analyse and decode interviews of patient with breast cancer, and then~     established according a multidimensional profile specific to the population and to create a~     questionnaire tha will allow a practical and qualitative evaluation of the quality of life.~   "
106598|NCT01661803|"~     The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby~     bringing about better quality and longer duration of analgesia, better sedation and better~     postoperative outcomes with minimal side effects.~   "
106599|NCT01661790|"~     To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a~     treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer~     (NSCLC).~   "
106600|NCT01661777|"~     The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian~     tube dysfunction with standard treatment for endolymphatic hydrops. Eustachian tube~     dysfunction is a common diagnosis made in otolaryngology related to abnormal pressure~     equalization of the middle ear space related to a swollen, inflamed, or occluded Eustachian~     tube. The symptoms of this include perceived hearing loss, a feeling of fullness in the~     affected ear/ears, ear pain, ear popping, and occasionally imbalance. These symptoms overlap~     with a more rare and difficult to diagnose condition known as endolymphatic hydrops, or an~     overproduction to fluid in the inner ear. The treatment for these two conditions are~     distinct and traditionally, patients are treated for Eustachian tube dysfunction first as it~     is much more common and there are several treatments, namely nasal steroids, antihistamines,~     and pressure equalization tubes. For patients who do not improve with these treatments, they~     are often treated with diuretics and a low salt diet to treat for supposed endolymphatic~     hydrops. There has never been a study to investigate the utility of these treatments in~     patients with refractory Eustachian tube dysfunction. There is also reason to believe that~     chronic ETD with effusion can lead to both inner and middle ear dysfunction. Thus, this~     study aims to determine the benefit of standard endolymphatic hydrops treatment on patient~     with refractory Eustachian tube dysfunction symptoms in a prospective fashion.~      Hypothesis:~      Patients with refractory Eustachian tube dysfunction (patients with no or minimal symptom~     improvement despite nasal steroid and antihistamine treatment followed by myringotomy tube~     placement) have an element of endolymphatic hydrops and these patient's symptoms will~     improve with a low sodium diet and diuretic.~   "
106601|NCT01661764|"~     Colorectal cancer is the second leading cause of cancer-related death within the United~     States. Animal models and observational studies have suggested that marine-derived n-3~     polyunsaturated fatty acids [PUFA] such as eicosapentanoic acid [EPA] and docosahexanoic~     acid [DHA] may reduce the risk of colorectal cancer. In addition, it may be the relative~     proportion of n-3 to n-6 PUFAs that best determines the chemopreventive effects of fish~     oils. This ratio is important because the n-6 PUFA, arachidonic acid (ARA), is converted via~     the cyclo-oxygenase (COX) pathway to prostaglandin E2 (PGE2), an inflammatory eicosanoid~     overproduced in colorectal neoplasms while EPA is converted to the anti-inflammatory~     prostaglandin E3 (PGE3). While the ratio of n-6 to n-3 PUFAs can be altered through dietary~     changes, genetic factors may also influence this ratio. Recent genetic studies have~     demonstrated that much of the tissue levels of ARA is determined by differences in a gene~     called fatty acid desaturase 1 (FADS1). FADS1 is the rate-limiting enzyme in the conversion~     of linoleic acid, the most commonly consumed PUFA in the Western diet, to ARA, and one~     particular genetic variant caller rs174537 is associated with lower fatty acid desaturase~     activity and subsequently lower tissue levels of ARA.~      The study hypothesis is that individuals with genetically determined lower activity of FADS1~     will derive greater benefit from fish oil supplementation than individuals with higher FADS1~     activity because of lower tissue levels of ARA and subsequently a more favorable n-6 to n-3~     PUFA ratio. To test this hypothesis the investigators will recruit 150 participants with~     recently identified adenomatous polyps and conduct a 6-month double blind 3 X 2 factorial~     randomized controlled trial. The first factor will be FADS1 genotype (GG, GT, and TT) and~     the second factor will be fish oil supplementation (fish oil versus placebo). The primary~     outcome will be the change in rectal epithelial cell growth and cell death. Secondary~     outcomes will include rectal epithelial cell expression of genes important in PGE2~     production, rectal cell production of PGE2 and PGE3, rectal mucosal tissue levels of fatty~     acids, and changes in biomarkers of inflammation (C-reactive protein), adipokines (leptin,~     adiponectin), and markers of insulin sensitivity.~      The specific aims include: 1) to determine the efficacy of fish oil supplements on rectal~     epithelial cell proliferation indexes and markers of rectal crypt apoptosis, and 2) to~     determine the effect of genetically-determined fatty acid desaturase 1 activity on fish oil~     supplementation for colorectal cancer chemoprevention. The investigators long-term~     objectives are to determine genetic factors that might influence the efficacy of fish oil~     supplementation in order to conduct a more definitive adenoma recurrence trial using~     marine-derived n-3 PUFAs. The investigators anticipate that fish oil will have~     anti-neoplastic effect and individuals with low FADS1 activity will have a greater response~     compared to individuals with high FADS1 activity~   "
106602|NCT01661751|"~     The clinical trial was designed to evaluate the safety and immunogenicity against Group~     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of~     age and older.~   "
106603|NCT01661738|"~     The clinical trial was designed to evaluate the safety and immunogenicity against Group~     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of~     age and older.~   "
106604|NCT01661725|"~     The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal~     Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.~   "
106605|NCT01661712|"~     The aim of this randomized, double-blinded, sham-controlled cross-over trial is to~     demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the~     pharyngeal dilator muscles to reduce sleep-disordered breathing.~   "
106609|NCT01661660|"~     Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems,~     behavioural and psychological symptoms (BPSD), and an impairment of activities of daily~     living (IADL) are frequently encountered and usually show an impact on autonomy maintenance,~     prognostic and care during the prodromal and early stages of the disease.~      Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well~     as their intensity increase with the evolution of the disease.~      Apathy, initially defined as a reduction of motivated behaviours, is the most frequently~     observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of~     interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized~     by diminished goal-directed cognitions and behaviours.~      Behavioural and psychological assessment relies essentially on neuropsychiatric scales.~     These are used to gather precise data regarding patient's clinical state from interviews~     with the patient, the career or from clinical impressions during the consultation. From~     their apparent simplicity they have made their way into daily clinical practices, yet~     neuropsychiatric scales are reportedly biased by the assessors' subjectivity.~      However, some tools whose allow simple, fast and objectively valid assessments are not~     widely used.~      Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities),~     automatized audio-video recognition and signal analysis from events, may be of interest in~     addition to current assessment methods.~      The aim of this study is to implement an objective assessment of goal directed activities~     and autonomy in an experimental design including predefined actions. The setting includes~     video cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and~     computer-based recognition of events using audio-video data, locomotion data and sinusal~     variability respectively as well as extracting biomarkers for supporting detection of~     dementia at early stages and supporting ongoing tracking of the dementia disease state. The~     following population will be included: patients with Mild Cognitive Impairment (n=50),~     patients with Alzheimer's disease (n=50) and control participants (n=50).~      This work will provide further objective information for clinical practitioner in order to~     detect behavioral disturbances such as apathy.~   "
106610|NCT01661647|"~     Problem : Precise and personalized 3D knee kinematic assessment during physical and daily~     life activities is a challenge; therefore, it was never performed on an important number of~     individuals. However, a better understanding of 3D knee kinematics during such activities~     would allow a better understanding of this often injured joint.~      Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation~     device that can be used under local anesthesiaallows for precise and reproducible assessment~     of 3D knee kinematics during physical and daily life activities.~      Objectives :~        -  To study human knee 3D kinematics during dynamic activities using a novel minimally~          invasive measuring system~        -  Investigate the correlations between standard clinical knee laxity tests and measured~          3D knee kinematics during dynamic activities~   "
106611|NCT01661634|"~     The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous~     (IV) ularitide infusion on the clinical status and outcome of patients with acute~     decompensated heart failure (ADHF).~   "
106612|NCT01661621|"~     This study is a prospective randomized, open label, controlled, double arm, post-marketing~     study to compare the treatment efficacy of first-line antimuscarinics and α-blockers~     monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)~     (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore~     ratio (IPSS-V/S) ≤1.~   "
106613|NCT01661608|"~     The primary objective is to collect data on the use of the EndoSurgical Operating System~     (EOS) for gastric tissue approximation during primary gastric restrictive procedures.~   "
106614|NCT01661595|"~     This study is funded by the Moody Endowment. In this project, we will investigate the~     potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle~     anabolism, muscle strength, physical function, and body composition in older individuals.~     Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and~     fatigability.~   "
106615|NCT01661582|"~     Exposure to particulate air pollution is associated with increases in cardiovascular~     mortality and morbidity. The pathophysiological mechanisms underlying this observation are~     emerging, and exposure to particulate air pollution has been shown to result in increases in~     blood pressure and arterial tone, impaired vascular function and an increased tendency for~     blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from~     panel studies and controlled exposure studies have suggested an increase in myocardial~     ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim~     to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust~     (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male~     patients with stable coronary disease and healthy male controls. We hypothesize that~     following exposure to dilute diesel exhaust:~        1. Myocardial blood flow will be reduced~        2. Coronary flow reserve will be impaired~        3. The magnitude of impairment will be higher in patients with coronary disease as~          compared to healthy controls~   "
106616|NCT01661569|"~     We propose a randomised controlled trial in a workplace setting to investigate whether a~     smartphone-delivered programme of mindfulness meditation influences psychological and~     biological indicators of well-being.~      We hypothesise that after 8 weeks participants who complete the meditation programme will~     show increases in psychological well-being and reduced activation of stress-related~     biological pathways.~   "
106617|NCT01661556|"~     Melasma is an acquired discoloration of the skin characterized by brown colour changes~     commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The~     control group will receive treatment with topical Hydroquinone (4%), and the other group~     topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for~     melasma patients. The estimated number of subjects to be recruited and randomized for the~     study is at least 30. The purpose of this study is determine if there is a difference in the~     effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be~     assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry~     and histological assessment will be also evaluated. Occurrence of adverse effects will also~     be recorded.~   "
106618|NCT01661543|"~     The purpose of this study is to compare how regularly eating (dried) beans or peas or rice~     (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total~     cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize~     that regularly eating beans or peas will significantly improve blood lipid profiles in these~     people.~      Participants in this study will consume 1 study food item 5 out of 7 days a week containing~     beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers~     by enhancing development of food products for human consumption and supporting marketing~     strategies to increase awareness that a diet rich in pulses can improve human health.~     Measuring changes in blood and urinary polyphenol levels will help to verify whether these~     compounds play a role in the beneficial actions of beans and peas and subsequently assist~     with the identification of the beneficial bean/pea components. This in turn, will enable~     crop breeders to select for plants that are rich in these compounds.~   "
106619|NCT01661530|"~     In the last forty years the prevalence of asthma has increased in westernised countries. We~     have hypothesised that this increase may be a consequence of changing diet. Several birth~     cohort studies have now reported an association between reduced maternal vitamin E intake~     during pregnancy and childhood asthma.~      However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy~     reduces the risk of childhood asthma. We are planning a large placebo controlled trial in~     pregnant women, to investigate whether optimisation of dietary vitamin E intake to the~     recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary~     intervention using vitamin E in its natural form of food is more likely to be successful and~     acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women~     can optimise their vitamin E intake using a personalised dietary plan with the help of a~     dietitian however this intervention was complex and could not be translated into everyday~     use. With commercial support we have developed a range of soups containing foods naturally~     rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of~     similar tasting and looking placebo soups has also been developed. In this study we will~     pilot a randomised controlled trial of the active and placebo soups to ascertain whether~     pregnant women are willing and able to optimise their vitamin E intake during pregnancy~     using the soups in order to reduce the risk of their child developing asthma. optimising~     maternal vitamin E intake during pregnancy.~   "
106620|NCT01661517|"~     This study will be a quality improvement project to review the effectiveness and barriers to~     effectiveness of a new clinical program in the emergency room to provide substance use~     screening followed by brief motivational interviewing and referral to treatment for patients~     who meet criteria for problem substance use. This study will consist of a chart review of~     the results of the screens performed by substance use counselors and correlating them to~     institutional variables such as wait time in the emergency room and length of stay as well~     as to patient variables obtained by chart review such as medical diagnosis and~     sociodemographic variables.~   "
106621|NCT01661504|"~     The overall goal of this proposed study is to develop the state of knowledge in the area of~     gender-based violence and reproductive health by conducting a randomized controlled trial to~     improve the health care provider's capacity to screen for intimate partner violence and to~     mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)~     with recent experiences of physical or sexual partner violence in Mexico City and its~     surrounding area.~      The specific research objectives are as follows:~        1. To increase mid-level health care providers' capacity to identify Intimate Partner~          Violence (IPV) and assist women with risk mitigation~        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health~          care worker screening and counselling program on (a) past year severe IPV (sexual or~          physical), including severe IPV; (b) reproductive coercion (c) use of community-based~          resources and safety planning; and (d) quality of life; versus minimum standard of care~        3. To qualitatively examine which programmatic components may serve as mechanisms for~          observed changes stated in the second objective~        4. To synthesize study findings and a) create recommendations for clinic-based~          intervention programs to address IPV in low and middle income countries and b)~          disseminate information as reports, presentation, and peer-reviewed publications~   "
106622|NCT01661491|"~     Cystic Fibrosis (CF) is a fatal, recessive genetic disorder characterized by progressive~     inflammation and lung damage. It is unclear whether current treatment strategies, which~     focus on detection and eradication of pathogenic microorganisms in the lung, are the best~     way to prevent the initiation of early inflammation and lung damage. This study asks how~     early acquisition of microbial flora occurs in infants with CF and healthy baby controls,~     and whether this process initiates or influences early inflammation and clinical disease~     progression in CF.~   "
106623|NCT01661478|"~     The purpose of this quality improvement research project is to briefly survey attitudes~     among healthcare providers toward patients with substance use disorders before and after~     substance abuse counselors are placed in the Emergency Room.~   "
106624|NCT01661465|"~     To ensure consistent documentation of alcohol and substance use, the emergency medicine is~     initiating a new standard of care for substance use screening: the use of a brief~     self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed~     in triage. This questionnaire will allow emergency medicine patients presenting to the~     emergency room. This study will also review medical records after one year of the index~     emergency room visit to establish rates or re-presentation and hospitalization correlated~     with different substance use.~   "
106625|NCT01661452|"~     A survey (patient self-report) of patients presenting to UAB emergency room, outpatient~     trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and~     maladaptive coping responses after the widespread tornado disaster that occurred in Alabama~     in April 2011.~   "
106626|NCT01661439|"~     Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with~     recurrent miscarriages with positive anti phospholipid antibodies increase the implantation~     rate and the duration of pregnancy with low complications to the mother and the baby.~   "
106627|NCT01661283|"~     To determine the clinical response rate of everolimus in combination with bevacizumab for~     patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated~     malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of~     everolimus in combination with bevacizumab in individuals with MPNST~   "
106628|NCT01661270|"~     Primary Objective:~      To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo~     in participants with metastatic colorectal cancer treated with FOLFIRI as second-line~     treatment for metastatic disease.~      Secondary Objectives:~      To compare the overall survival (OS) in the 2 treatment arms. To compare the overall~     response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment~     arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.~   "
106629|NCT01661257|"~     This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing~     molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with~     Crohn's disease during anti TNF-α (infliximab) therapy.~   "
111099|NCT01602055|"~     The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets~     (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference~     product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd~   "
106630|NCT01661244|"~     RV568 is being developed as a possible treatment of smoking related lung disease (also known~     as Chronic Obstructive Pulmonary Disease - COPD).~      The main purpose of this study is to examine the safety and tolerability of a new inhaled~     formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and~     Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as~     a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568~     given once a day for 14 days.~   "
106631|NCT01661231|"~     BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from~     BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to~     separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents~     in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for~     the treatment of femoro-popliteal lesions, located in the native superficial femoral artery~     (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the~     treatment of the common or external iliac artery lesions.~   "
106632|NCT01661218|"~     The investigators aim to determine the complications and risk factors related with~     peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in~     cancer patients.~   "
106633|NCT01661205|"~     The purpose of this study is to assess the safety and technical feasibility of treating~     subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation~     in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar~     System, with mapping and additional lesion creation/ gap closure (as needed) provided by~     currently approved catheter technology, when the epicardial and endocardial phases are~     performed in a staged manner within 1-10 days apart, during the same hospitalization.~   "
106634|NCT01661192|"~     At a previous study the investigators have assessed the safety and efficacy of treatment~     with AAT(Alpha 1 Antitrypsin)in newly diagnosed type 1 diabetes subjects aiming at beta~     cells preservation .~      Since treatment with AAT is expected to be a chronic treatment; stopping treatment will~     probably result in eventual loss of the preserved beta-cell function. Indeed, other~     investigational drugs aiming at beta cells preservation have shown that patients who were~     initially treated and maintained their initial beta-cell function, required continuation of~     treatment or they lost the beta-cell function.~      Therefore, in this extension study, patients who were previously treated with AAT and~     maintained clinically significant beta-cell function are offered a continuation of~     treatment, since they are likely to benefit from use of the medication.~      The proposed study is aimed to assess the long term effect of AAT in subjects with type 1~     diabetes mellitus: safety and tolerability of treatment, and effect on beta-cell function.~      Subjects who have completed all visits of the 008 study will be offered to participate in~     the extension study.~      The study will be consist off two main arms as following:~      Arm 1: Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2 nmol/L will~     continue treatment with AAT for up to 18 treatments according to the dosage group they were~     allocated to in the 008 study.~      Arm 2:~      Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L and~     subjects with peak stimulated C -peptide secretion ≥ 0.2 nmol/L who are reluctant to receive~     additional study drug.~      Clinical follow up for all subjects in both arms will be for 3 years~   "
106635|NCT01661179|"~     Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in~     Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid~     Carcinoma.~   "
106636|NCT01661166|"~     The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity~     (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and~     to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.~     Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.~   "
106637|NCT01661153|"~     This prospective observational study will evaluate the use in clinical practice, efficacy~     and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients~     with HER2-negative metastatic breast cancer. Data will be collected from eligible patients~     for up to 2.5 years.~   "
106638|NCT01661140|"~     This randomized, placebo-controlled, double-blind study will compare the safety and efficacy~     of tapering methotrexate (MTX) versus maintaining MTX dosage in patients with severe active~     rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drugs~     (DMARDs) initiated on treatment with tocilizumab. Participants will receive tocilizumab 8~     mg/kg intravenously every 4 weeks and MTX orally weekly throughout the study. At Week 24,~     participants achieving a good/moderate EULAR response will be randomized receiving the MTX~     Tapering arm or MTX Maintenance arm. Up to Week 56 participants will receive either tapering~     or stable dose MTX in combination with tocilizumab. From Week 56 to Week 72 participants~     will receive tocilizumab monotherapy.~   "
106639|NCT01661127|"~     Psoriasis is associated with increases in markers of inflammation in the skin and blood and~     increasingly is thought to be a systemic inflammatory disease and risk factor for incident~     diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death.~     Furthermore, it is important for clinicians to be aware that psoriasis can have a~     substantial emotional impact on an individual, which is not necessarily related to the~     extent of skin disease.~      FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner~     that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that~     chronic disease such as end stage renal disease with depressive symptoms have decreased~     cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was~     designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of~     cerebral glucose metabolism and association with metabolic syndrome/major depressive~     symptoms in patients with psoriasis.~   "
106669|NCT01660737|"~     The aim of this observational study is to document the therapeutic use of PASCALLERG ® for~     hay fever. Based on the survey is a decrease in disease-specific symptoms when taking~     PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility~     can be assessed.~   "
106670|NCT01660724|"~     The main purpose of the study is to evaluate whether the routine use of ultrasound guided~     arterial puncture can increase the proportion of patients who only needs one puncture~     attempt in order to successfully extract enough blood to make an arterial blood gas~     analysis, when ultrasound guided arterial puncture is compared to conventional arterial~     puncture technique.~   "
106640|NCT01661114|"~     Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers~     leading to responses in a substantial minority and increasing survival. The use of the~     FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical~     experience within the University of Michigan Pancreatic Program leads to an expectation of~     tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative~     to FOLFIRINOX include:~        1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at~          least as good as irinotecan (probably better, especially when delivered by FDR~          [fixed-dose rate] infusion) and gemcitabine is much better tolerated with less~          diarrhea, nausea/emesis, myelosuppression and alopecia.~        2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression,~          mucositis and diarrhea.~        3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold~          aggravated dysesthesia.~      Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the~     investigators believe this treatment may be more widely applicable to pancreatic-biliary~     cancer patients, including those with advanced disease as well as being considered for use~     in locally advanced and neo- and adjuvant settings.~   "
106641|NCT01661101|"~     Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying~     than those who do not. One in 10 patients with myocardial injury will die within 30 days of~     surgery. This risk of death exists up to one year after myocardial injury. There are~     currently no treatments or guidelines available for heart injury after surgery, but there is~     evidence that taking a blood-thinner can prevent some of the deaths, both in the short and~     long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and~     omeprazole) that may prevent mortality, major cardiovascular complications and major upper~     gastrointestinal bleeding in patients who have had myocardial injury after noncardiac~     surgery.~   "
106642|NCT01661088|"~     The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination~     of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic~     disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to~     address local disease, will achieve a significant improvement R0 resection (Radiation~     oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and~     enhance disease free and overall survival in this patient population.~   "
106643|NCT01661075|"~     The purpose of this pilot project is to determine whether using inertial sensors placed on~     the waist during routine clinical balance testing (i.e. Balance Error Scoring System)~     (BESS), will be a more immediate, objective, reliable and sensitive way to measure and~     quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The~     investigators are also trying to observe if the sensors can be used to detect balance~     recovery after a mTBI.~      The investigators hypothesis is that collegiate atheltes with mTBI injury will have~     different recovery periods between their cognitive testing(IMPACT) and their balance~     measures.~   "
106644|NCT01661062|"~     Cone beam CT (computed tomography) is a developing technology which allows CT images to be~     obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to~     produce detailed pictures of structures in the body.) In this study, cone beam CT scans will~     be obtained before individual radiation treatment sessions for head and neck cancer. The~     information gathered from these scans will be used by the researchers to look at patient~     movement as well as changes in the amount of normal and tumor tissue throughout the course~     of radiation therapy. The researchers will use this information to create hypothetical~     radiation treatment plans, which will be used as the basis for future research. The cone~     beam CT scan data will not be used to alter the actual radiation treatment of any of the~     patients enrolled on the study. In addition, tests of salivary output and swallowing and~     questionnaires about quality of life will be made to assess how the doses of radiation~     affect them.~   "
106645|NCT01661049|"~     To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and~     survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and~     at time of operation.~   "
106646|NCT01661036|"~     Background:~      - The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at~     health-related topics. It is being developed for the Department of Health and Human~     Services. Researchers want to see how easy or difficult the FLASHE survey questions are to~     understand and answer. They will interview parents and teenagers to test the survey~     questions.~      Objectives:~      - To test the FLASHE survey questions on teenagers and their parents.~      Eligibility:~        -  Adolescents between 11 and 18 years of age.~        -  Parents of the participating adolescents.~      Design:~        -  Participants will have a one-on-one interview to test the survey questions. The~          interview will last up to an hour and a half. Participants will be allowed to skip any~          questions that they do not wish to answer.~        -  Participants will receive financial compensation for their time.~   "
106647|NCT01661023|"~     Background:~      - Breast cancer is becoming more common in Africa. A higher number of cases appear in women~     under age 35 than in the developed world. However, little is known about the factors that~     may contribute to breast cancer in Africa. Researchers want to collect information from~     female patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this~     information with that obtained from healthy women in the general population. These two~     hospitals treat most breast cancers in Ghana. The data will provide information regarding~     factors that predispose to the development of breast cancer among women in Ghana.~      Objectives:~      - To identify and study breast cancer risk factors in women in Ghana.~      Eligibility:~        -  Women between 18 and 74 years of age who are diagnosed with breast cancer.~        -  Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women~          without breast cancer will be identified from the 2010 Ghanaian Census for comparison~          purposes~      Design:~        -  Participants will answer questions about their health and lifestyle.~        -  Height, weight, and waist/hip measurements will be collected.~        -  Blood and saliva samples will be collected.~        -  Participants will be given a collection kit to collect a stool sample.~        -  Treatment will not be provided as part of this study.~   "
106719|NCT01660334|"~     To collect the efficacy and safety information of voriconazole related to their appropriate~     use in daily practice.~   "
106720|NCT01660321|"~     A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in~     pediatric subjects 6 months to 4 years of age with an active head lice infestation.~   "
106648|NCT01661010|"~     Purpose/Lay Summary: Background:~      - Chromosomes are the structures inside of each cell that carry our genetic material~     (genes). Certain differences in the sex chromosomes are known to cause various diseases,~     such as infertility, Turner syndrome, or Klinefelter syndrome. However, it is not fully~     understood why these differences are seen and what clinical findings may be caused with~     different sex chromosome variants. This study is seeking to learn more about the genetic and~     clinical characteristics of disorders related to the X and Y chromosomes.~      Objectives:~      - To study related medical conditions in people with sex chromosome variants.~      Eligibility:~        -  Patients with known sex chromosome differences may be eligible to participate.~        -  Healthy volunteers age 18 - 55~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  This study will last about 5 days. Participants will have a variety of endocrine and~          other tests. They will provide blood, urine, and semen samples for these tests.~        -  Imaging studies of the heart and abdomen will be performed. These tests may include~          ultrasounds and magnetic resonance imaging.~        -  Participants will also have their vision and hearing checked.~        -  Healthy volunteers with have a single day visit for a medical history, physical exam,~          and blood and skin samples.~        -  Treatment will not be provided as part of this study.~        -  Compensation is offered.~   "
106649|NCT01660997|"~     Background:~      - Smoldering multiple myeloma (SMM) is a condition that can lead to multiple myeloma, a type~     of blood cancer. In many high-risk cases, SMM can develop into multiple myeloma in less than~     2 years. The current standard of care for SMM is follow-up without treatment until multiple~     myeloma develops. However, some drugs are being studied to see if they can slow down or~     prevent the disease from progressing. One such drug is MLN9708. It has shown some results~     against multiple myeloma. Researchers want to combine MLN9708 with dexamethasone to see how~     it works against high-risk SMM.~      Objectives:~      - To see if MLN9708 with dexamethasone is a safe and effective treatment for high-risk~     smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have high-risk smoldering multiple myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and a bone marrow biopsy may also be~          performed.~        -  Participants will take MLN9708 and dexamethasone on a regular schedule for 28 days.~          They will take each drug four times at regular intervals during each cycle of~          treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will have 12 cycles of treatment. After four cycles, patients will be~          recommended to have their own stem cells collected and stored. This will allow the~          potential application of a highdose melpahalan/autologous stem cell transplant in the~          event there is a need in the future (not part of this study).~        -  After 12 cycles, participants will keep taking MLN9708 as long as the disease does not~          progress and the side effects are not too severe.~   "
106650|NCT01660984|"~     Background:~      - Medullary thyroid cancer (MTC) is a rare cancer of the thyroid gland. In children and~     young adults, it is often part of a condition called Multiple Endocrine Neoplasia 2 (MEN2).~     MEN2 is usually caused by a genetic mutation, and it can cause a number of problems in~     addition to MTC. These problems include adrenal gland tumors, hormone changes, and problems~     with the bones and other organs. Not much is known about how MTC develops over time,~     especially in people with MEN2. Researchers want to study MTC in children and young adults~     and see how it affects their growth and development.~      Objectives:~      - To study how medullary thyroid cancer affects children and young adults over time.~      Eligibility:~      - Children and young adults younger than 25 years of age who have medullary thyroid cancer.~      Design:~        -  Participants will be screened with a brief physical exam and medical history. Blood and~          tissue samples will be collected to see whether participants have the MEN2 genetic~          mutation.~        -  Treatment will not be provided as part of this study. However, participants will be~          receiving standard care for MTC. They may be eligible for other clinical trials at the~          National Institutes of Health.~        -  Participants will have regular study visits every 6 to 12 months to evaluate their MTC~          and any treatment. Blood tests, imaging studies, and other tests may be performed as~          needed to monitor the disease.~        -  Participants and their parents/guardians will also complete questionnaires about their~          health and emotions during the study.~   "
106651|NCT01660971|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and~     dasatinib when given together with erlotinib hydrochloride in treating patients with~     pancreatic cancer that has spread to other places in the body or cannot be removed by~     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and~     dasatinib together with erlotinib hydrochloride may kill more tumor cells.~   "
106666|NCT01660776|"~     Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas~     in western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent~     chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this~     disease remains a biologically heterogeneous entity. New therapeutic strategies are required~     including identification of patients' subgroups with different prognostic.~      This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood~     transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was~     overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in~     plasma of DLBCL patients with a significantly higher concentration than in controls. This~     protein was selected as a potential biomarker because of its established role in~     anti-tumoral immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit~     activation of immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover,~     a direct involvement of PD-L1 in the protection of cancer cells from lysis by activated T~     lymphocytes has been demonstrated. PD-L1 expression has been described in several solid~     tumours, including ovary cancer, breast cancer, colon cancer, renal cell carcinoma,~     non-small cell lung carcinoma and in hematological malignancies such as T-NHL, MM and~     Hodgkin's lymphoma. Furthermore the expression of PD-L1 by tumour cells is associated with~     poor prognosis. The blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach~     in aggressive cancers. These first results incite to identify the cells releasing soluble~     PD-L1 and to investigate its role in the anti-tumoral immunity in DLBCL patients.~      The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at~     diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer,~     Hodgkin's lymphoma, non-small cell lung cancer).~   "
106770|NCT01659385|"~     The purpose of this study is to evaluate Leptin levels in females, in the setting of~     papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid~     disease.~   "
106652|NCT01660958|"~     Project Grow Smart evaluates the impact of a 12-month intervention of~     micronutrient-fortified food and an early learning intervention on young children's~     cognitive ability. There is an infancy phase and a preschool phase.~      The infant phase is conducted through home visits - micronutrient sachets are distributed to~     be mixed with food. The preschool phase is conducted in Anganwadi Centers. Hypothesis #1 is~     that infants who receive both the micronutrients and the early learning intervention will~     have better scores on measures of child development than children who receive neither.~     Children who receive one of the two interventions will have intermediate scores. Hypothesis~     #2 is that preschoolers in Anganwadi Centers that receive the micronutrient-enriched food~     wll have better scores on measures of child development than children in Anganwadi Centers~     who do not.~      The preschool phase is conducted in Anganwadi Centers (AWC), which are like preschools.~     Preschoolers age 36-48 months are recruited. AWC are classified as high or low stimulation,~     based on a rating system (Early Childhood and Childcare Environmental Rating Scale, ECERS).~     AWC are randomized into 2 cells: 1) multiple micronutrient-fortified food or 2)~     placebo-fortified food. Preschoolers receive the food in the AWC; their mothers receive~     information on iron-rich food. For both phases, evaluations are conducted at recruitment and~     after 6 and 12 months and focus on changes in the children's cognitive performance and~     micronutrient (iron) status.~      The investigators hypothesize that innovative multiple micronutrient (MN) fortification~     strategies for infants and preschoolers combined with early learning opportunities will~     impact children's micronutrient status, growth and development in Nalgonda district of~     Andhra Pradesh, India.~   "
106653|NCT01660945|"~     The investigator hypothesize that vytorin may improve vascular and insulin resistance in~     hypercholesterolemic patients~   "
106654|NCT01660932|"~     The investigators hypothesize that omega does-dependently improves vascular and insulin~     resistance.~   "
106655|NCT01660919|"~     The investigators hypothesize that rosuvastatin does-dependently worsens insulin~     sensitivity.~   "
106656|NCT01660906|"~     This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse~     Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from~     imatinib to dasatinib.~   "
106657|NCT01660893|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and~     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.~   "
106658|NCT01660880|"~     -  To estimate dopamine receptor occupancy by aripiprazole using computer simulation~        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the~          antipsychotics~        -  To validate the simulation result by comparing the receptor occupancy from the~          simulation with that from the patients~   "
106659|NCT01660867|"~     This is a prospective, randomized, controlled, double-blinded, clinical trial~      Subject : 3mo ~ 24mo. aged infants with bronchiolitis~      The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.~   "
106660|NCT01660854|"~     In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after~     Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected~     mosquito-bites respectively. The availability of this immunized cohort opens the unique~     opportunity to determine protection to a heterologous challenge for both of the protected~     and unprotected volunteers as the previous challenge infection might have served as~     immunological boost to the unprotected volunteers.~      In the current observational, proof of principle study, the investigators aim to investigate~     the protection on an individual basis of these previously immunized and challenged~     volunteers against a heterologous P. falciparum challenge.~   "
106661|NCT01660841|"~     Purpose of the study is to look at the safety (what are the side effects) and efficacy (how~     well does it work) of gadobutrol when used for taking images of the brain and spine. The~     results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images~     taken without contrast (gadobutrol).~   "
106662|NCT01660828|"~     Strenuous exercise in apparent healthy individuals increases plasma (high sensitive)~     troponin levels. The underlying mechanism is not yet elucidated, but could be explained by~     changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and~     reperfusion injury. If the mechanism underlying the troponin release during exercise is~     similar to that of ischemia reperfusion injury (IRI), than it should be susceptible to~     remote ischemic preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI.~     To test this hypothesis healthy volunteers underwent a strenuous exercise test with or~     without preceding RIPC.~   "
106663|NCT01660815|"~     This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed~     throughout the body of Japanese subjects.~   "
106664|NCT01660802|"~     This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment~     Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6~     month double-blind period versus sham followed by a 2 month open label period.~   "
106665|NCT01660789|"~     This study aims to evaluate the effect of a 40- week multifactorial intervention against~     overweight, obesity and physical inactivity in Danish children.~      The investigators wish to examine 40 children before and after the Fit for Kids~     intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip~     ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat~     mass.~      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and~     hormonal effect of the intervention with a more extensive examination programme.~      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring,~     pedometer monitoring, cognitive testing, Continuous Glucose Monitoring System, different~     metabolic and inflammatory markers and an oral glucose tolerance test. The study will take~     place at Centre of Inflammation and Metabolism, Rigshospitalet, Copenhagen.~      The study is a randomised controlled trial with a gradual rollout. The 40 children will be~     randomised. Twenty children will start the intervention at baseline and 20 children will~     start after the first 20 weeks of intervention, thus providing a control group.~      The investigators expect to find a significant reduction in BMI, total body fat mass and~     systolic blood pressure after the intervention. As for the more extensive tests, the data~     approach is explorative, as the investigators look at more statistical dependent variables.~     The contribution of this project is a further description on the effect of intervention~     against overweight and physical inactivity on the metabolic and inflammatory response.~   "
106671|NCT01660711|"~     The purpose of the study is to demonstrate that it is possible to administer chemotherapy~     prior to and following surgery for pancreatic cancer which is considered operable. The~     chemotherapy chosen is that which has been shown to be the most effective in treating~     metastatic disease, and the goal is both to investigate whether this is tolerable and also~     to investigate the efficacy of this approach in terms of disease response and survival.~   "
106672|NCT01660698|"~     The purpose of the current study is to evaluate the effect of administering a probiotic~     strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in~     seasonal allergic rhinitis subjects.~   "
106673|NCT01660685|"~     This is a randomized controlled trial with enhanced usual care treatment control. The aim is~     to determine the effects of journaling and use of resource website on weight loss. There~     will be two groups of 55 participants each. The intervention condition will be asked to~     record daily weight, physical activity steps taken and pre-portioned food items and to~     complete two daily journaling activities. Participants will also receive weekly tracing~     data, a weekly blog from the principal investigator and have access to a weight control~     website. The control group will not have access to the tracking, journaling or website for~     three months. Investigators hypothesize that a website paired with tracking and journaling~     will be more effective in helping participants lose weight.~   "
106674|NCT01660672|"~     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%~     and leaving one third of survivors with long term neurologic and psychiatric sequelae.~     Seizures occur commonly with CM and are associated with an increased risk of death and~     neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and~     feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the~     groundwork for future efficacy studies aimed at improving seizure control and ultimately~     decreasing the neurologic morbidity of pediatric CM.~   "
106675|NCT01660659|"~     Personal exposure to Indoor Air Pollution (IAP) is a known risk factor of severe pneumonia,~     which is the number one killer of children under five in developing countries. The main~     source of IAP in developing countries is cooking fires, with an estimated 3 billion people~     still reliant on biomass stoves for their daily cooking. This study will test the~     effectiveness of an intervention aimed to reduce IAP, as well as help to quantify the~     relationship between exposure (IAP) and infection (pneumococcal carriage).~      In Phase I (adjunct pilot study L2010.99), 3 fuels and 5 stoves were tested to measure~     harmful pollutant emissions. The preliminary results showed that the largest difference was~     found in the fuels (briquettes cleaner than wood), with a smaller difference found between a~     couple of the improved stoves and the traditional 3-stone. Re-testing of selected stove/fuel~     combinations to confirm findings has just been completed. Phase II (this proposal) will test~     the biomass briquettes in a randomized clinical trial to measure actual IAP reductions in~     households. A proof of concept pneumococcal survey will also be conducted as a secondary~     study to see whether reduced exposure to IAP affects pneumococcal carriage in babies and~     mothers~   "
106676|NCT01660646|"~     This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF)~     strategy will be compared to passive TB case reporting in The Gambia. And that the impact of~     ECF on community and household transmission of TB will also be assessed.~      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will~     increase TB case notifications in The Gambia and reduce TB burden in the study area in a~     cost effective manner. The impact of ECF on community and household transmission of TB will~     also be assessed. The investigators hope this trial will contribute to this evidence base.~     The timing alongside a nationwide TB prevalence survey is particularly of benefit as that~     would provide a baseline for disease burden against which the investigators may be able to~     compare case notification or case detection in selected clusters~   "
106677|NCT01660633|"~     The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL~     for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple~     myeloma patients (MM) undergoing autologous transplantation.~   "
106678|NCT01660620|"~     We hypothesize that topical betaxolol will reduce the development of severe retinopathy of~     prematurity.~   "
106679|NCT01660607|"~     For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with~     a T cell depleted graft, the infusion of naturally occurring regulatory T cells with~     conventional T cells (T cell addback) in pre-defined doses and ratios will reduce the~     incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and~     improving immune reconstitution.~   "
106680|NCT01660594|"~     Patients with stable chest pain presenting to general practitioners in UK are routinely~     referred to the chest pain clinics in the hospitals. They are assessed by clinical history~     including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT~     calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying~     calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical~     Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain~     who have low likelihood of coronary artery disease (CAD). They recommend that patients with~     low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have~     non-cardiac chest pain. However, there is controversy regarding relationship of absent~     calcification with significant CAD and its prognostic value.~      At our institution, we have been performing CTCS in this patient cohort since 2003. We plan~     to retrospectively review the usefulness in CTCS in patients with different likelihood for~     significant CAD, particularly in patients with absent calcium and compare with the~     traditional assessment. We also plan to follow-up these patients for any myocardial~     infarction and death from any cause.~   "
106681|NCT01660581|"~     The purpose of the study is to evaluate the efficacy of therapy with autological CD133+~     cells in patients with angina resistant to pharmacological treatment and without the~     possibility of effective revascularization. Cells will be isolated from patients bone marrow~     and administered directly into the muscle of left ventricle. The main objective is to assess~     the treatments' influence on improvement of myocardial perfusion and function, and on~     decrease of occurrence of symptomatic angina.~   "
106682|NCT01659788|"~     The goal of the investigators research is to explore energy production of the ovarian~     follicle in older reproductive age women at the time of oocyte retrieval.~   "
106683|NCT01659775|"~     This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.~      The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System~     (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR)~     of Chemotherapy Induced Nausea and Vomiting (CINV).~      Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for~     1-5 days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy.~     Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit~     (1 to 2 days prior to HE chemotherapy).~        -  Sancuso patch~        -  Zofran inj. + Zofran tab.~      The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic~     chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient~     will be assessed daily until 5days after first chemotherapy administration. Adverse Events~     (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be~     followed-up until 2 days after the final dose of IP. Serious adverse events will be~     followed-up until they are resolved, stable or until the patient is lost to follow-up.~   "
106684|NCT01659762|"~     In this Phase I trial the investigators intend to show safety and tolerability of autologous~     MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media.~     Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus~     dose in a dose escalation phase I study. The investigators intend to test whether the~     product is clinically safe in adults (18-65 years old) with CD and to determine maximal~     deliverable dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.~   "
106685|NCT01659749|"~     The purpose of this project is to study the effectiveness of teaching teens and young women~     with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD) about their disease and~     nutrition related issues in a camp environment. It will also look at pregnancy outcome~     results in women with PKU who attended Metabolic Camp and compare their results to other~     women with PKU who have not attended the Metabolic Camp.~   "
106686|NCT01659736|"~     This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by~     conducting a pilot randomized-controlled trial (RCT) comparing structural~     neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized~     Anxiety Disorder (GAD).~   "
106687|NCT01659723|"~     The primary objective of this study is to assess the relief of symptoms after Hyperbaric~     Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate~     cancer Index Composite (EPIC)symptom estimation scale as primary variable.~      Study hypothesis:~        -  HBOT can reduce or reverse the change or otherwise limit the damage of the bladder~          function and/or structure, which arose as a result of radiation therapy of cancer in~          the pelvic region organs.~        -  The effects of HBOT are associated with relief of symptoms that, at least in part, is~          related to the reduction of the extent of the radiation damage.~        -  Vascular density increases, fibrosis prevalence and inflammatory activity are reduced~          as a sign of an improved function of the mucosa.~        -  Treatment results of HBOT remains, in whole or in part, during the follow-up (residual~          effect)~   "
106688|NCT01659710|"~     The purpose of this study is to research a new type of test for cerebral palsy that can be~     performed earlier, at 10-15 weeks of age (after the due date for premature infants). The~     test involves a standardized video recording of a baby's natural movements for about 10~     minutes. The video recorded movements are evaluated by a special trained observer and also~     by a computer program. There are some small studies from Europe that suggest that this type~     of evaluation may be accurate in early diagnosis of cerebral palsy. However, the~     investigators do not know if this type of evaluation is reliable in large groups of infants,~     including infants from Children's Memorial Hospital, who tend to be sicker and have more~     complicated illnesses than many of the European infants. The investigators would therefore~     like to evaluate whether this type of video recording could be used in the future for early~     diagnosis of cerebral palsy.~   "
106689|NCT01659697|"~     This study will evaluate the feasibility and efficacy of two interventions of lifestyle (~     intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25~     to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in~     the Central district, using resources existing in this Health Care system (HMO).~   "
106690|NCT01659684|"~     Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from~     unselected donor pools including a varying proportion of donors previously exposed to CMV -~     has not yet been explored in pregnant women, the investigators performed a longitudinal~     prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV~     infection.~   "
106691|NCT01659671|"~     Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing~     pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6~     months in patients with OSAS.~      Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of~     poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can~     elevate the risk for traffic accidents. Increased morbidity and three to four times~     increased mortality in these patients are well documented, mainly in the cardiovascular~     field. Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was~     the predominant treatment for OSAS worldwide before continuous positive airway pressure~     (CPAP) devices became widely available in the 1990s. Since then, the main treatment for OSAS~     has been CPAP, but an increasing number of patients are also treated with mandibular~     retaining device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The~     evidence-grade for the efficacy has so far been very low, and the side-effects and~     complication rate has raised the question whether there is a place for surgical treatment of~     OSAS. However, the compliance for CPAP and dental devices are quite low (50-60%), leaving a~     lot of patients untreated if surgery is not offered. RCT UPPP is still missing and called~     for.~   "
106692|NCT01659658|"~     The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves~     hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and~     mortality rate versus a physician's choice of a chemotherapy regimen in participants~     diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.~   "
106986|NCT01656538|"~     Researchers doing this study want to evaluate the side effects of Reolysin when given~     together with paclitaxel. As these drugs have not been given together before, 6-9 patients~     will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.~   "
106693|NCT01659645|"~     Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in~     2010 leading to 39,840 cancer related deaths.~      Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has~     become the a standard method for isolating the tumor. However, FDG is insensitive in small~     breast tumors and certain histologic types such as lobular, certain types of breast~     carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions~     may also evidence have accumulation of this radiotracer. Hence there is a need for a~     tracer/imaging tool that increases the ability to characterize detect breast carcinoma and~     to detect locoregional spread, as well as monitor therapeutic treatment response.~      anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino~     acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell~     culture experiments,FACBC has shown uptake in the breast tumor cell line.~      The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within~     breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics~     via time-activity curves from dynamic imaging characteristics. The investigators will enroll~     12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to~     undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care~     imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The~     investigators will then compare findings to determine if this radiotracer is worthy of~     further study in a more comprehensive experiment.~   "
106694|NCT01659632|"~     Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are~     weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal~     bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal~     bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be~     detected and impossible to treatment if endoscopy is performed according to the warning~     signs. National gastric cancer screening is conducted in men and women of more than 40 years~     old. The purpose of screening for gastric cancer is discovering a case of possible cure, so~     increasing the survival rate. The purpose of this study is review of the feasibility of~     screening for gastric cancer.~   "
106695|NCT01659619|"~     Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor~     complex with longer and stronger contraction.~      In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could~     clear the stomach of blood, so visual examination could be improved.~      Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is~     postulated that erythromycin reduce food stasis and help to improve endoscopy in these~     cases.~   "
106696|NCT01659606|"~     Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically~     causing failure of the blood system. Lung disease, liver disease and cancer are other~     frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood~     system but can make the lung and liver disease and risk of cancer worse, because of DNA~     damaging agents such as alkylators and radiation that are typically used in the procedure.~     Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA~     damaging agents in patients with DC, and still have a successful BMT. In this protocol we~     will test whether a regimen that avoids DNA alkylators and radiation can permit successful~     BMT without compromising survival in patients with DC.~   "
106697|NCT01659593|"~     Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the~     disease. They effect personal life. Their management may be overlooked. The evidence-based~     program proposes exercises to both stimulate preserved functions and develop new abilities~     compensating for cognitive disabilities.~      Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed~     for MS patients, compared to an interactive discussion program(DISINT) 140 multiple~     sclerosis patients will be randomly assigned in one the program for 13 sessions over a~     6-month period.~      Main outcome criteria is evolution of SRT-LIST before and after program.~   "
106698|NCT01659580|"~     This phase III study is designed as a double blind, randomized, multi-nation, multi-center,~     placebo controlled clinical research, which aims to evaluate the safety and efficacy of~     Dantonic® (T89) in patients with chronic stable angina pectoris.~   "
106699|NCT01659567|"~     This prospective observational study will investigate predictive values of virological~     response in peginterferon/ribavirin treatment-naive patients with chronic hepatitis C.~     Patients will be treated with Pegasys (peg-interferon alpha 2a) and Copegus (ribavirin) as~     prescribed by the physician. Data will be collected for 72 weeks.~   "
106700|NCT01659554|"~     The primary objective of this study is to investigate the feasibility, tolerability and~     safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC)~     followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian,~     primary peritoneal, and fallopian tube carcinomas.~   "
106701|NCT01660568|"~     We retrospectively review patients with refractory or relapsed ENKL who received a~     gemcitabine-containing regimen~   "
106702|NCT01660555|"~     The human microbiota forms a highly complex ecosystem with its host, consisting of hundreds~     of different species of microorganisms, the majority of which have not yet been cultured.~     With the recent advent of small subunit rRNA (SSU rRNA) gene sequencing technology, it is~     estimated that the number of specific gastrointestinal tract phylotypes is more than 1800.~     Sampling techniques might constitute a major confounder in the read-out of highly sensitive~     techniques such as SSU-DNA analysis.~      It is not properly established whether there is a difference in distribution of luminal~     bacteria or mucosa adherent bacteria proximal or distal in the colon. In addition, 'bowel~     lavage' before endoscopy might result in a disturbance of the microbiota in the bowel. For~     this proof of concept study a novel device capable of taking 'protected' biopsies has been~     designed.~      We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal~     to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to~     show the real distribution of microbiota according to the localisation in the colon.~      Furthermore, we hypothesize that microbial diversity will differ after bowel lavage.~   "
106703|NCT01660542|"~     This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of~     sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed~     by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or~     cytologically confirmed axillary lymph nodes metastasis.~   "
106704|NCT01660529|"~     Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV~     multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive~     basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be~     administered at the time of Vaccines 1,3, and 5. Patients who remain clinically stable after~     the fourth vaccine, may continue to receive vaccinations every 4 weeks for up to 2 years.~   "
106705|NCT01660516|"~     Tea consumption may impact upon the decrease in endothelial function after IR-injury.~     However, no previous study directly examined the potential of tea to impact upon the change~     in endothelial function after IR-injury.~      The investigators hypothesize that tea consumption counteracts endothelial damage in~     response to ischaemia reperfusion injury in healthy humans.~   "
106706|NCT01660503|"~     Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties~     in rats and in adolescent boys and girls.~   "
106707|NCT01660490|"~     An expert panel of surgeons agreed that there is not any established, standardized approach~     to the teaching of intraoperative imaging and that there may be practice gaps in decision~     making and the use of imaging among trauma surgeons.~      The panel is set to initiate a consensus-based evaluation process to develop a list of~     criteria for assessing images and would like to validate these criteria for differentiating~     good quality versus poor quality images in term of reliability and accuracy.~   "
106708|NCT01660477|"~     The purpose of this two part study is to assess the effect of multiple doses of~     isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the~     effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.~      Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or~     isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate~     safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir~     on isavuconazole.~      Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,~     lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.~   "
106709|NCT01660464|"~     Cognitive-behavioral based guided self-help for parents of adolescents with~     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and~     effectiveness study. The treatment is offered under routine-care conditions of the~     health-care system in Germany. Practicability, treatment participation and effectiveness is~     documented and tested in a one-group pre-test/post-test design.~   "
106710|NCT01660451|"~     The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in~     patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after~     standard therapy. 30 patients will be enrolled to both indolent and aggressive disease~     group. The objective of the study part B is to evaluate the efficacy and safety of~     BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be~     enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics~     and biomarkers. Quality of life will be a further objective of part B of the study.~      In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed~     to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.~      After an up to 28-day screening period, eligible patients will start treatment with~     BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).~      Treatment will be continued until disease has progressed or until another criterion is met~     for withdrawal from study. An end-of-treatment visit will be performed within 7 days after~     discontinuation of study treatment. Thirty to 35 days after last study drug administration,~     a safety followup visit will be performed for the collection of adverse events (AEs) and~     concomitant medication data. Patients will be contacted quarterly to determine overall~     survival status up to 3 years after last patient first treatment. In Part B, patients will~     enter the Active Assessment Followup Period. The end of study notification to Health~     Authorities will be based on the completion of the collection of survival data.~      The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at~     Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months~     during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor~     tissue and blood samples will be collected for biomarker analysis (mandatory) and for~     central pathology review (part B), fresh biopsy tissue will also be collected if available.~   "
106711|NCT01660438|"~     This is a prospective, non-randomized, observational, multicenter study in which urethral~     length is measured in women with surgically-correctable stress urinary incontinence who~     undergo a suburethral sling operative procedure.~   "
106712|NCT01660425|"~     The main purpose of this study is to evaluate the effectiveness of a parenting enhancement~     training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity~     Disorder (ADHD) who are already medicated with methylphenidate.~   "
106713|NCT01660412|"~     Pain during nuclear medicine breast lymphnode detection procedures has been reported as high~     as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain~     can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.~      In sites other then the breast, using Bicarbonate to make the injection's pH closer to~     natural, attempts to lower the pain levels will be performed.~      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be~     reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH~     7.40.~   "
106714|NCT01660399|"~     This predictive, randomized, double-blind, multi-center trial is going to evaluate the~     efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a~     second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous~     cell lung cancer patients.~   "
106715|NCT01660386|"~     The objective of this study is to demonstrate the different effects of two DPP-4~     inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and~     second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the~     different effects of the study drugs on the GLP-1 response, and the glucagon concentration~     which indicates alpha cell function in healthy subjects.~   "
106716|NCT01660373|"~     This is a single-center, open-label prospective randomized pharmacodynamic investigation of~     two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment~     elevation acute coronary syndrome(NSTE-ACS) for 24 hours~        1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)~        2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min~             -  both agents will be given on top of aspirin~   "
106717|NCT01660360|"~     The primary objective of this study is to assess the safety, tolerability, and maximum~     tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are~     refractory or for whom there are no standard therapeutic option.~        -  To evaluate the pharmacokinetics of Tanibirumab in such patients~        -  To determine a recommended phase II dose (RP2D) of Tanibirumab based on above~          assessments~   "
106718|NCT01660347|"~     This clinical trial studies how well donor stem cell boost works in treating patients with~     low blood cells after donor stem cell transplant. Donor stem cell boost may increase low~     blood cell counts caused by hematologic cancer or its treatment.~   "
106721|NCT01660308|"~     Fibroblast froth factors (FGFs) are humoral factors identified by their ability to stimulate~     cell proliferation1. They play different roles in the regulation of cell proliferation,~     differentiation and function. Most FGF family members act as paracrine factors. But~     FGF19(FGF19) subfamily members, including FGF19, 21, and 23, work as endocrine factors to~     regulate bile acid, carbohydrate and phosphate metabolism2. Of these, FGF23 plays an~     important role in phosphate and bone metabolism3. FGF23 gene encodes 251 amino acids,~     including a 24-amino acid signal peptide4. The secreted FGF23 is a protein consisted of 227~     amino acids. It works by binding to a Klotho-FGF receptor 1c (FGF1c) complex5. FGF~     suppresses the expression of type 2a and 2c sodium-phosphate cotransporters, which mediate~     phosphate reabsorption in proximal tubules.6 FGF23 decreases 25-hydroxyvitamin~     D-1α-hydroxylase expression and enhances 25-hydroxyvitamin D-24-hydroxylase expression6.~     Therefore, FGF23 reduces serum 1,25-dihydroxyvitamin D〔1,25(OH)2D〕, which stimulates~     intestinal calcium and phosphate absorption. FGF23 decreases serum phosphate through the~     above mechanisms FGF23 over-expression might result in hypophosphatemic rickets and~     osteomalacia.~      Tumor induced osteomalacia (TIO) is a paraneoplastic syndrome usually caused by benign~     phosphaturic mesenchymal tumors. Symptoms are nonspecific, such as general weakness,~     fatigue, and bone pain. Sometimes fracture may occurs. The responsible tumors are sometimes~     small and difficult to detect. Tumors secrete FGF23. FGF23 reduced phosphate reabsorption in~     the proximal tubules and decrease 1,25(OH)2D levels, which result in hypophosphatemia and~     then osteomalacia.~      The investigators would like to observe the changes of FGF23 in patients who receive~     operation or medical treatment and hope this will benefit future treatment.~   "
106722|NCT01660295|"~     This study will assess the pharmacokinetics in subjects with severe renal insufficiency and~     healthy subjects.~   "
106723|NCT01660256|"~     The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective~     compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a~     reference drug.~   "
106724|NCT01660243|"~     This study is being conducted to investigate the efficacy of MT-9938 compared with placebo~     after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore~     the effect of a reduction in itching intensity on health-related Quality of Life(QoL)~     domains, especially those which recent research suggests have a positive correlation with~     overall survival for this patient group. The study will consist of the following phases:~     Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1~     week) culminating in a Follow-up Visit (1 week after the last dose).~   "
106725|NCT01660230|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of single~     and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55~     years.~   "
106726|NCT01660217|"~     This is a randomized controlled study. The control group will consist of adult subjects and~     the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis~     (AD), who are visiting a dermatologist for a standard AD office visit. In the control group,~     only verbal instruction (VI), the standard of care, will be provided. The intervention group~     will receive a similar VI with an additional component: an eczema education handout, as well~     as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize~     disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed~     step-wise instructions regarding treatment modifications for the above-mentioned variations~     in treatment severity. To ensure that all patients ultimately receive the same level of~     care, the control group will also receive an EAP at the end of their consultation.~      The goal of this study is to assess subjects' perception in the provider's use of an EAP and~     its effectiveness in helping patients understand their disease and management plan. In order~     to evaluate the primary end-points, subjects in both the control and treatment groups will~     be asked to complete post-consultation surveys. Four post-consultation outcomes will be~     measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers'~     comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD~     at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or~     neither the EAP nor the VI.~   "
106727|NCT01660204|"~     The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic~     strategies for patients with community-acquired pneumonia admitted to the hospital, but not~     the ICU.~   "
106728|NCT01660191|"~     The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than~     Atorvastatin or Rosuvastatin.~   "
106729|NCT01660178|"~     To describe the profile of newborns undergoing early stimulation in a neonatal intensive~     care unit, characterizing the study population, according to its variables and neonatal risk~     factors, indications for treatment of early stimulation.~   "
106730|NCT01660165|"~     There is increasing evidence that psychosocial factors may affect health by means of~     biological effects and changes in behavioral health. Observational studies suggest an~     association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic~     acid), after pregnancy and the occurrence of postpartum depression (PPD). This is an~     observational cohort with 4 waves of follow-up and a nested clinical trial with pregnant~     women residing in the city of Rio de Janeiro. The general objective is to describe the~     magnitude and identify factors associated to common mental disorders (CMD) during pregnancy~     and postpartum giving emphasis to maternal nutritional status.~      Main specific objectives:~        1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and~          child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low~          birthweight, small for gestational weight and prematurity), considering the effect of~          other determinant factors, and~        2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.~   "
106731|NCT01660152|"~     The purpose of this study is to determine which technique in using a vacuum erection device~     (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern~     for both the surgeon and the patient. Recent studies have shown that beginning to use the~     vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile~     shrinkage. This is a potential issue that can occur because of decreased blood flow after~     prostate cancer surgery. This study will allow researchers to determine and compare vacuum~     therapy techniques and erectile function outcomes of patients who have prostate cancer~     surgery~   "
106732|NCT01660139|"~     This study is to assess the practice of complementary and alternative medicine (CAM) for~     skin related conditions among patients in the Primary Care and Dermatology clinics.~   "
106771|NCT01659372|"~     tempromandibuar disorders are a group of heterogenous pathologies affecting~     temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of~     pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of~     cases pain is the major complaint.we run this investigation to find the analgesic effct of~     low level laser therapy versus pharmacotherapy with naproxen in improving pain.~   "
106733|NCT01660126|"~     Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although~     by definition SCH comprises biochemically mild thyroid hormone deficiency without overt~     symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone~     has effects on numerous physiological systems, including the vascular tree, heart, skeletal~     muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency~     has the potential to give multisystem benefits to older people with SCH.~      Small studies have reported reduced atherosclerosis and improved heart function with~     thyroxine replacement, but no large clinical trials have been performed. Therefore the~     available evidence is limited, leading to major variations in guidelines and clinical~     practice, with uncertainty regarding the indications for screening and treatment. The~     investigators propose a multicentre randomised placebo controlled trial to assess the impact~     of thyroxine replacement in 540 older adults with persisting SCH (excluding those in whom it~     is a temporary phenomenon who are unlikely to benefit). The investigators will include older~     men and women with a wide age range and of varying health status. Outcomes include health~     related quality of life, muscle strength, executive cognitive function and cardiovascular~     events, with a minimum of 1 year of follow up. Blood and urine samples will be stored in a~     biobank, to allow future research on causes of ill health in older people with SCH.~      The investigators have the support of patient advocacy groups and a consortium with the wide~     range of expertise and experience required to conduct large scale multicentre clinical~     trials. The proposal explores the multisystem and quality of life benefits to older people~     of a tailored approach to management of SCH.~      This clinical trial should definitively clarify whether thyroxine treatment for SCH provides~     benefits that are relevant for patients. This trial will provide strong evidence with the~     potential to improve clinical practice, reduce health care costs and promote healthy ageing~     of older adults.~   "
106734|NCT01660100|"~     Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF)~     ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation~     plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be~     conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF~     (Persistent AF and Long Standing Persistent AF).~      Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of~     left atrial posterior wall is associated with more freedom from atrial arrhythmia at~     long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.~   "
106735|NCT01660087|"~     The overall objective of this proposal is to develop a non-invasive, inexpensive and~     accurate device that detects VOCs in exhaled breath for lung cancer screening. Toward this~     goal, the team will design and fabricate a biophotonic platform consists of arrays of~     silicon micro-ring resonator sensors coated with polymers with different organic~     functionalities, in which each sensor is widely responsive to a variety of VOCs for the~     detection of lung cancer by means of breath testing. The team will identify signature VOCs~     as lung cancer biomarkers by comparison VOC contents between alveolar gas that directly~     sampled from the nodule or mass and exhaled breath using gas chromatography/ mass~     spectrometry.~      The specific aims of this proposal are as followings:~      Aim 1: To develop a biophotonic platform for the detection of VOCs~      Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a~     novel biophotonic device.~      Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and~     lung cancer breath samples~   "
106736|NCT01660074|"~     The purpose of ths study was to evaluate the glycemic index and glycemic response of food~     and products that produced in Tiwan. The food and product are in includes local produced~     fruits, starchy food and bread made from resistant starch.~   "
106737|NCT01660061|"~     To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with~     the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.~   "
106738|NCT01660048|"~     Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most~     commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions:~     a 2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the~     navel for insertion of trocars into which dissecting instruments are inserted to perform the~     repair. Although this method has been shown to be relatively safe and efficient there are~     reports of bowel and vascular injuries from the insertion of the smaller trocars which are~     usually sharp. These can cause serious injuries.~      Since 2009, a newer method of performing the key hole repair has been developed. This~     involves placing a special single port under the navel via a 2-2.5cm incision and into which~     3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In~     addition the fact that only a single incision is used this could potentially result in less~     pain, reduced incidence of wound complications including infection and improved cosmetic~     results.~      However these potential advantages have not been proven in rigorous clinical studies as the~     single port technique is still relatively new. It is hoped that this study will prove that~     the single port technique is at least as effective and efficient as the conventional~     technique in the cure of hernias and may have additional benefits as enumerated above.~      Neither you nor your surgeon will know which procedure (three port or single port hernia~     repair) until you are already asleep in the operating room and a random number selecting~     process will automatically assign you to one procedure or the other. Sometimes it is not~     possible to perform the single port safely in which case your procedure will be converted to~     a three ports procedure.~      All patients having surgical treatment of groin hernia at Holroyd Private Hospital are~     subject to very careful assessment and study. All patients are requested to report~     immediately if there are any problems. Any problems would normally be reported to your~     treating surgeon who has primary responsibility for your care. Problems can be reported~     directly to Holroyd Private Hospital. Any information in your medical records is subject to~     stringent confidentiality requirements. The hospital is bound by the Australian Privacy~     Council Charter as regards confidentiality and privacy.~   "
106739|NCT01660035|"~     The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in~     the REVERSE and RAFT pivotal studies in real-world clinical practice.~   "
106740|NCT01660022|"~     A Phase I Study to investigate the safety, tolerability & pharmacokinetics of~     co-administered single doses of OZ439 and Piperaquine to healthy subjects.~   "
106741|NCT01660009|"~     Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with~     increased cardiovascular risk. However, whether there is a causal relationship between~     cardiovascular events and hypoglycemia remains unclear with conflicting data in the~     literature. In this study, we plan to study whether acute exposure of patients to clinically~     relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel~     endothelial dysfunction- a key 1st step in the development of heart attacks and strokes.~     This will be determined in humans both with and with type 2 diabetes.~   "
106742|NCT01659996|"~     The aim of the study is to further characterize the safety and immunogenicity of Menactra®~     in the population <2 years of age when administered alone and when the second dose is~     administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine.~      Primary Objectives:~        -  To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and~          W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first~          vaccination visit and 15 to 18 months at the second vaccination visit.~        -  To evaluate and compare the antibody responses to Pertussis (pertussis toxoid [PT],~          filamentous haemagglutinin [FHA] and pertactin [PRN]) antigens induced by a dose of~          Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of~          Pentacel® administered alone.~        -  To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP),~          tetanus and diphtheria antigens induced by a dose of Pentacel® when administered~          concomitantly with Menactra® to those elicited by a dose of Pentacel® alone.~      Observational Objectives:~        -  To describe the safety profile (immediate unsolicited AEs within 30 minutes of each~          trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited~          AEs within 30 days of each vaccination, and serious adverse events [SAEs] throughout~          the course of the trial from Day 0 up to Day 30 after the last trial vaccination[s]) in~          all trial groups~        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,~          measured by SBA HC, 30 days after the second Menactra® administration~        -  To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria,~          tetanus, polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA),~          radioimmunoassay (RIA), or functional assays.~   "
106743|NCT01659983|"~     Research hypothesis:~      Does delayed primary wound closure after appendectomy in adults with complicated~     appendicitis reduce postoperative superficial surgical site infection compare to primary~     wound closure.~      Study design:~      This study is a multicenter randomized controlled trial of delay versus primary wound~     closure in complicated appendicitis.~      Setting:~      Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira~     Hospital, and Pathumthani Hospital~      Participants:~      Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as~     gangrenous or ruptured appendicitis.~      Outcome:~      Superficial surgical site infection~      Period of study:~      August 2012 - August 2014~   "
106744|NCT01659970|"~     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in~     second line in patients with locally advanced or metastatic squamous non-small cell lung~     cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients~     will be followed for 12 months.~   "
106745|NCT01659957|"~     In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective~     than typical counseling, but BCT is not widely used because standard BCT delivered one~     couple at a time is costly to deliver and does not fit with the primary group therapy focus~     of most community clinics. The proposed study will test with married or cohabiting alcoholic~     patients whether a group format for BCT will produce similar positive outcomes as standard~     BCT, and deliver these results at a lower cost. If outcomes are favorable, this could prompt~     clinics to start using group BCT and improve outcomes for alcoholic patients and their~     families.~   "
106746|NCT01659944|"~     The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg~     twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in~     healthy adults.~      The secondary objective is to assess the safety and tolerability of a single oral dose of~     metoprolol 50 mg when administered alone and in combination with repeated oral doses of~     eliglustat 150 mg BID in healthy adults.~   "
106747|NCT01659931|"~     The objective of this study was to prove the bioequivalence of Montelukast Tablet under~     fasted conditions~   "
106748|NCT01659918|"~     The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed~     conditions~   "
106749|NCT01659905|"~     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet~     under fasted conditions.~   "
106750|NCT01659892|"~     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet~     under fed conditions~   "
106751|NCT01659879|"~     The aim of this study is to determine whether multimedia based health information presented~     in a pediatric acute ward to parents of children with breathing difficulties due to lower~     respiratory tract infections, is more effective than verbal information to reduce the~     parent's anxiety and to increase satisfaction with nursing care and health information.~   "
106752|NCT01659866|"~     This study is being conducted in men scheduled to undergo transrectal ultrasound-guided~     prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic,~     ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years~     as ciprofloxacin resistance has increased in the community, more and more men are becoming~     infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being~     done to determine if obtaining rectal swab cultures and choosing antibiotics based on these~     culture results will result in fewer infectious complications than giving all men~     ciprofloxacin.~      The investigators will compare 2 groups: men whose rectal swabs do not show~     ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose~     swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on~     their culture results. Our hypothesis is that these 2 groups will have equal numbers of~     post-biopsy infectious complications and both groups will have fewer infectious~     complications than a historical group who received empiric ciprofloxacin without the benefit~     of rectal swab culture results.~   "
106753|NCT01659853|"~     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel~     0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily~     in subjects with moderate to severe facial erythema of rosacea.~   "
106754|NCT01659840|"~     The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the~     same efficacy in relieving pain and improving the quality of life of TMD patients~   "
106755|NCT01659827|"~     The purpose of this study is to determine whether the AmnioFix Injectable human amniotic~     membrane is effective in the treatment of recalcitrant plantar fasciitis.~   "
106756|NCT01659814|"~     The overall aim of this study is to utilize an integrative research model in order to~     dynamically assess reward-related dopamine (DA) transmission in major depressive disorder~     (MDD) and test the role of dysfunctional DA release in depression and anhedonia.~      The first arm of this line of research (PET scan) aims to investigate phasic DA release in~     MDD during incentive motivation. The investigators will utilize an established molecular~     imaging technique to measure striatal DA release dynamically during performance of testing~     and control versions of a monetary incentive delay task, which involves anticipation and~     receipt of monetary rewards. In doing so, this experiment will link together independent~     lines of research that have associated depression with decreased hedonic responsiveness,~     impaired reinforcement learning and dysfunctional DA transmission. We hypothesize that,~     relative to matched controls, unmedicated MDD subjects will show reduced reward-related~     ligand (11C-raclopride) displacement. Reduced ligand displacement will be interpreted as~     indicating reduced task-induced release of endogenous striatal DA in response to~     reward-predicting cues and unpredictable reward in MDD subjects.~      In the second arm of this research (EEG recording), the investigators aim to probe the~     spatio-temporal dynamics of brain mechanisms underlying positive and negative reinforcement~     learning in MDD and their relations to phasic DA. Participants will perform the~     probabilistic stimulus selection task (PSST) while event-related potentials (ERPs) are~     collected. The investigators expect that, relative to matched controls, unmedicated MDD~     subjects will show reduced positive reinforcement learning, potentiated negative~     reinforcement learning, and larger (i.e., more negative) feedback-related negativity (FRN)~     in response to positive reinforcement (indicative of reduced DA transmission). Moreover, the~     investigators hypothesize that a more negative FRN in response to positive reinforcement~     will be associated with decreased striatal raclopride displacement (i.e., lower release of~     endogenous DA) as measured by PET in the first part of the study. This experiment will~     investigate the effects of blunted DA transmission on behavioral and ERP markers of both~     positive and negative reinforcement learning.~   "
106772|NCT01659359|"~     In recent studies using virtual reality has been proposed as a non pharmacological methods~     for pain relief but until this time , its effects has not been assessed on pain and anxiety~     during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain~     and anxiety in Primiparity women during episiotomy repair.~   "
106773|NCT01659346|"~     Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be~     screened for presence of large esophageal varices and will be randomized between~     non-selective beta blocker versus primary endoscopic variceal ligation. They will be~     followed to assess the rate of reduction of index bleed rate as well as survival difference~     between the groups.~   "
106757|NCT01659801|"~     With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a~     clear, well contrasted image. The only therapeutic solution to this problem is surgical~     replacement of the crystalline lens with an intraocular lens (cataract surgery).~      In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism.~     In cases of severe corneal astigmatism, the standard IOL might not provide the optimal~     result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing~     Incisions might be required.~      BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior~     alternative to surgical treatment of pre-existing corneal astigmatism.~      The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm~     incisions.~      The aims of this study are to:~        -  Demonstrate a reduction in refractive cylinder compared to pre-operative corneal~          astigmatism~        -  Exceed monocular best corrected distance visual acuity results provided in ISO~          guidelines.~   "
106758|NCT01659541|"~     The purpose of this trial is to determine the efficacy of spinal cord stimulation, using~     wire leads, to produce an effective cough in patients with spinal cord injuries.~   "
106759|NCT01659528|"~     The purpose of this study is to establish nomograms of penile length and width throughout~     the weeks of pregnancy.~   "
106760|NCT01659515|"~     The primary purpose of this protocol is to make arbekacin available for treatment of~     patients with infections caused by multidrug-resistant organisms when treatment with other~     antibiotics cannot be used due to unavailability, intolerance, contraindications, or~     treatment non-response.~   "
106761|NCT01659502|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118~     alone or in combination with pancreatic cancer chemotherapy.~   "
106762|NCT01659489|"~     Adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of~     2.7-3%. The need for prompt diagnosis and treatment in order to save ovarian tissue has been~     realized a long time ago. A marker that will aid in the diagnosis of torsion and prevent~     missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of~     unecessary laparoscopic interventions is much needed. To our knowledge, such marker has not~     been found. The purpose of this study is to find a marker using blood/serum from patients~     undergoing laparoscopy for suspected ovarian torsion~   "
106763|NCT01659476|"~     The objectives of this research are to compare (i) the bronchodilating and (ii) the~     bronchoprotective effects of deep inspirations (DIs) in individuals with: (a) asthma, (b)~     CVA, (c) methacholine-induced cough but normal airway sensitivity and .~      (d) in healthy individuals (without asthma, chronic cough or asymptomatic airway~     hyperresponsiveness).~      Hypotheses:~      i. The bronchodilating effect of a DI will be: (a) absent or impaired in individuals with~     classic asthma; (b) impaired in individuals with CVA; (c) preserved in individuals with~     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy~     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).~      ii. The bronchoprotective effect of a DI will be: (a) absent in individuals with classic~     asthma; (b) impaired in individuals with CVA; (c) preserved in those with~     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy~     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).~      iii. Healthy individuals without asthma, chronic cough, or asymptomatic airway~     hyperresponsiveness, will not cough, or develop significant dyspnea, small airways~     obstruction or dynamic hyperinflation during high-dose methacholine bronchoprovocation.~   "
106764|NCT01659463|"~     Material for caries prevention dont have better results compared with non-operatory~     interventions.~   "
106765|NCT01659450|"~     Investigators presumed that low energy density (LED) diet consumers will have lower risk of~     cardiovascular disease and are able to maintain their weight longer .~   "
106766|NCT01659437|"~     This is a WHO-sponsored trial.~      Combination therapy with streptomycin and rifampicin has been the standard antibiotic~     treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory~     Group recommended that a trial be carried out to develop a fully oral treatment for the~     disease. Although the current treatment is effective, injection with streptomycin is a~     problem. Several small observational studies (published and unpublished) have shown that a~     fully oral treatment is promising.~      This WHO sponsored study will be a randomized, controlled open label non-inferiority phase~     II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel~     treatment groups. The ultimate goal is to search for an effective alternative treatment to~     the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes~     injections of streptomycin with inherent logistic, operational and safety disadvantages.~      Financial and material support:~        1. American Leprosy Missions, USA~        2. Raoul Follereau Foundation, France~        3. MAP International, USA~        4. Sanofi, France~        5. 7th Framework Programme of the European Union: BuruliVac project (241500)~        6. Aranz Medical Limited, New Zealand~   "
106767|NCT01659424|"~     Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy~     given with chemotherapy at the same time. External beam radiation can increase side effects~     both short and long-term by exposing normal tissue nearby the tumor such as the bladder,~     bowel and sexual organs. Instead, this study will use a different way of delivering~     radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be~     given three chemotherapy medications both before and after surgery: oxaliplatin (also called~     EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic~     Acid).~      The purpose of this study is to find out whether giving chemotherapy and brachytherapy~     before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the~     risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy~     and external beam radiation therapy and 4) improve patient's ability to complete~     chemotherapy.~   "
106768|NCT01659411|"~     Multi-center, observational, U.S.-based longitudinal program. Data will be collected~     prospectively for 3 years. Individual physician feedback will be provided on data collected~     with the purpose of improving the management of patients - quality enhancement research~     initiative (QuERI) process from adult patients enrolled with a history of repaired~     Congenital Heart Disease (CHD).~   "
106769|NCT01659398|"~     The aim of this study is to investigate whether enhanced external counterpulsation (EECP)~     therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time~     enhance or slow down breakdown of cognitive function in patients diagnosed with mild~     cognitive impairment (MCI).~   "
106774|NCT01659333|"~     Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis~     (PD) patients but so far objective methods for DW assessment have not been established for~     daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a~     body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of~     brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial~     stiffness.~   "
106775|NCT01659320|"~     This research study will examine whether elderly depressed patients whose depressive~     symptoms do not respond satisfactorily to therapy with a mood stabilizer or antidepressant~     alone gain any benefit from taking minocycline alone or in addition to their antidepressant~     or mood stabilizer medication. Minocycline is a commonly used antibiotic medication with~     anti-inflammatory properties. It is hoped that information gained from this study will help~     the investigators better understand the role of inflammation in depression, and whether~     decreasing inflammation will lead to improvement in the symptoms of depression and cognitive~     function.~   "
106776|NCT01659307|"~     This is a double-blind, placebo-controled, randomized trial to investigate if aspirin~     pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by~     inhaled endotoxin (LPS) in healthy human volunteers.~   "
106777|NCT01659294|"~     This study will examine whether patients with diabetes who are either 1) newly discharged~     from hospital or 2) referred to an endocrinologist for management will have better diabetes~     outcomes when their care is managed primarily by a dedicated case manager (intervention)~     than by an endocrinologist (standard care) after 6 months of treatment.~   "
106778|NCT01659281|"~     The main purpose of this study is to compare artesunate-mefloquine combination therapy given~     for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum~     malaria.~   "
106779|NCT01659268|"~     The purpose of this study is to compare if there difference in acquisition of knowledge and~     skills in airway management to baccalaureate nursing students submitted to different~     learning strategies: exhibition-dialogued class and practical activity in skill lab with~     low-fidelity mannequin or simulation class with low-fidelity mannequin.~   "
106780|NCT01659255|"~     This is an open-label, multi-center, phase I dose-escalation study to investigate the safety~     and tolerability of ONO/GS-4059 given as monotherapy to patients with relapsed/refractory~     NHL and CLL.~   "
106781|NCT01659242|"~     In rheumatoid arthritis patients with active disease despite optimal treatment with~     methotrexate, the main objective of this pilot study is to use advance imaging tools such as~     magnetic resonance imaging and ultrasound to evaluate which treatment option is more~     efficacious: initiating methotrexate/sulfasalazine combination therapy, or switching to~     leflunomide monotherapy~   "
106782|NCT01659229|"~     The investigators are comparing the range of movements the knees of patients who had total~     knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a~     Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee~     system designed to combine function with wear resistance. It can accommodate up to 150~     degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which~     can accommodate up to 120 degrees of flexion.~   "
106783|NCT01659216|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation with~     acupuncture needles as electrodes has a good long-term therapeutic effect on the~     urgency-frequency syndrome in women.~   "
106784|NCT01659203|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational intervention. Phase I studies also try to define the appropriate dose of~     the investigational therapy to use for further studies. Investigational means that the~     intervention is still being studied and that research doctors are trying to find out more~     about it.~      Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen.~     Typically, patients with retroperitoneal sarcomas either have surgery for the removal of~     their tumors alone, or have their tumors removed, followed by standard radiation therapy, or~     have pre-operative radiation followed by surgery. When conventional radiation therapy is~     delivered after surgery, it can damage normal tissue. In this study, you will undergo proton~     beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.~      Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny~     particles with positive charge that can be controlled to travel a certain distance and stop~     inside the body. In theory, this allows better control of where the radiation dose is~     delivered as compared to photons. Since proton radiation is more targeted, it may help to~     reduce unwanted side effects from radiation.~      In this study, a standard dose of radiation will be given to the majority of the tumor,~     while a simultaneously integrated boost of additional radiation will be given to certain~     areas of the tumor identified as higher risk. This means that a higher radiation dose will~     be given to the higher risk areas of the tumor.~      The purpose of this study is to determine the highest dose of radiation therapy with protons~     or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the~     effectiveness of proton beam radiation therapy as an intervention for patients with~     retroperitoneal sarcomas.~   "
106785|NCT01659190|"~     Urinary infection is one of the most common bacterial infections in pediatrics and requires~     urine collections to be diagnosed. In France, among children under 3, urine samples are~     collected thanks to collecting bags.~      Work teams have set as their main goal to compare the different levels of acute pain~     involved for children under 3 during the removing of the collecting bag, depending on the~     use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a~     main endpoint, the difference between the results assigned to the acute pain by a pain~     evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).~   "
106786|NCT01659177|"~     The study will evaluate the effect of food on absorption of LY2140023 in blood. This study~     involves a single dose of 80 mg LY2140023 taken as a tablet by mouth on 2 occasions, once on~     an empty stomach and once after eating breakfast. There is a minimum 3 day washout between~     doses. This study will last approximately 16 days not including screening. Screening is~     required within 30 days prior to the start of the study.~   "
106787|NCT01659164|"~     The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of~     a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is~     to build relational skills, skills in organizing and structuring everyday life, handle~     difficult emotions and impulses etc. The treatment will be in a group format and it is~     hypothesized that the psychological intervention will result in reduced ADHD symptoms and to~     decreased experience of stress and depressive symptoms. The uncontrolled design does not~     allow for any causal inferences from the results, this pilot study is primarily to be seen~     as a preparation before a subsequent RCT.~   "
106788|NCT01659151|"~     The purpose of this study is to find out more about the effects of an investigational~     combination of medicines, which includes special immune cells (T-cells).~      A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood~     cell that protect the body from viral infections, help other cells fight bacterial and~     fungal infections, produce antibodies, fight cancers, and coordinate the activities of other~     cells in the immune system.~   "
106792|NCT01659099|"~     This study is designed to investigate:~        -  the interest of a new monoclonal antibody (GA101)versus rituximab~        -  the interest of PET to identify early responders~      Patients will receive either rituximab (standard treatment), either GA101 (study treatment),~     according to the randomization arm.~      The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to~     site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and~     after 4 chemotherapy cycles, to identify early patients responders, for who consolidation~     with ASCT is not required.~   "
106793|NCT01659086|"~     The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of~     different formulations of a two-dose primary series and booster vaccination of monovalent~     Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults~     18 to 64 years of age.~   "
106794|NCT01659073|"~     The investigators propose that Arterial Spin Labelling Functional Magnetic Imaging will be~     able to capture functional changes associated with caloric vestibular stimulation and better~     delineate the etiology of the pain augmentation that has been documented with this~     intervention.~   "
106795|NCT01659060|"~     The purpose of this study is to to test the feasibility of design methods and procedures for~     later use on a larger scale and to examine the acute and chronic effect of consumption of~     flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant~     women.~   "
106796|NCT01659047|"~     The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and~     duration of tumor control~   "
106797|NCT01659034|"~     The purpose of this study is to evaluate safety of reduction of thienopyridine treatment~     period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.~   "
106798|NCT01659021|"~     This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on~     progression-free survival (PFS) in participants with previously treated chronic lymphocytic~     leukemia (CLL).~   "
106799|NCT01659008|"~     Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the~     amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding~   "
106800|NCT01658995|"~     This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be~     conducted within the Mayo Clinic and the Mayo Clinic Health System.~      The goal of the research study is to gather information to determine whether Doxycycline is~     effective for the treatment of unacceptable bleeding associated with the etonogestrel~     subdermal implant (ESI), as compared to placebo.~   "
106801|NCT01658982|"~     Optimizing patient survival and organ utility is a constant struggle for the liver~     transplant community. Despite rigorous cardiovascular evaluation before liver~     transplantation cardiovascular events are one of the leading causes of post-transplant~     morbidity and mortality in both early and late post transplant periods. Poor performance on~     measures of cardiopulmonary fitness has been associated with worse outcomes in liver~     transplant candidates. The investigators seek to determine the feasibility of obtaining~     measures of cardiopulmonary performance in liver transplant candidates from standard~     cardiopulmonary exercise testing (CPET) and from a modified 3 minute step test and to~     determine whether the 3 minute step test is suitable for the assessment of cardiopulmonary~     fitness in a future outcome study.~   "
106802|NCT01658956|"~     The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile~     neutropenia among patients with breast cancer, treated with chemotherapy and presenting with~     a low to moderate risk of developing febrile neutropenia.~   "
106803|NCT01658943|"~     This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work~     compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in~     treating patients with metastatic pancreatic cancer previously treated with chemotherapy.~     Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt~     inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients~     with metastatic pancreatic cancer.~   "
106804|NCT01658930|"~     The reason this study is being done is to see if a simple hysterectomy is as good as a~     radical hysterectomy in preventing cancer of the cervix from returning, and whether, because~     less tissue surrounding the uterus is removed during surgery, there are fewer side-effects~     after the surgery and in the long-term.~   "
106805|NCT01658917|"~     Background:~      The NCI Surgery Branch has developed experimental therapies that involve taking white blood~     cells from patients' tumor or from their blood, growing them in the laboratory in large~     numbers, and then giving the cells back to the patient.~      Objective:~      This study will allow tissue samples obtained during the protocol screening process to be~     used for future and ongoing research in the NCI Surgery Branch~      Eligibility:~      Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment~     Protocol~      Design~      Patients will undergo testing and evaluations as required by the appropriate NCI Surgery~     Branch Treatment protocol~   "
106819|NCT01658735|"~     The intent of this project is to execute a high-quality double-blinded randomized controlled~     clinical trial that compares the H-Wave® device with a commonly used TENS device with a~     sub-therapeutic electrocurrent device. This study will provide a definable level of evidence~     for treatment efficacy, and provide a basis for evidence-based recommendation for or against~     utilization for these two modalities. The results for H-Wave® device, if positive, could~     significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for~     symptomatic relief, and reduce overall disability and health care costs associated with~     chronic low back pain.~   "
106820|NCT01658722|"~     A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in~     Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies~     ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.~   "
106937|NCT01657175|"~     This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric~     cancer surgery and to develop and test an information and support program aiming to enhance~     the patients quality of life (QOL) after surgery. The project contains 3 part-studies~     focusing on the patients life after surgery.~      Data will be collected through focus group interviews and a randomized controlled trial~     (RCT) study.~   "
106806|NCT01658904|"~     Background:~      - Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow.~     It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy~     with a stem cell transplant. To make this treatment more effective, researchers want to give~     another drug along with the transplant. This drug, carfilzomib, is often used to help treat~     plasma cell myeloma. However, it is not usually given along with the transplant. Researchers~     want to see if it is safe and effective to combine the stem cell transplant with~     carfilzomib, and if it improves the results of the transplant.~      Objectives:~      - To test the safety and effectiveness of carfilzomib given with stem cell transplant for~     plasma cell myeloma.~      Eligibility:~      - Individuals between 18 and 75 years of age who are having a stem cell transplant to treat~     plasma cell myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and a bone marrow biopsy will also be~          performed.~        -  Participants will have their own stem cells collected for the transplant. The~          transplant will be performed according to the standard of care.~        -  All participants will receive carfilzomib on the first 2 days after transplant. The~          study doctors will determine the number of additional doses that they may have.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
106807|NCT01658891|"~     single center, double-blind, double-dummy, 2-way cross over study in asthmatic children~     already treated with inhaled corticosteroids~   "
106808|NCT01658878|"~     The first part of the study is the Dose Escalation Phase designed to establish the safety of~     nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular~     carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B~     virus (HBV)-infected subjects).~      The second part of the study is the Expansion Phase designed to generate additional clinical~     data at specified doses for each of the 3 cohorts. A third cohort has been added in this~     study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A~     fourth cohort will generate data on the safety and efficacy of the combination nivolumab~     plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical~     data will be generated for Child-Pugh B subjects.~   "
106809|NCT01658865|"~     The purpose of this study is to assese esophageal motor function by simplified transnasal~     endoscopy compared with esophageal manometry.~   "
106810|NCT01658852|"~     Recent study showed that SIBO is common among postgastrectomy patients and It appears to be~     associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO~     could be a new therapeutic target for managing intestinal symptoms in postgastrectomy~     patients.The purpose of this study is to determine whether antiboitic (metronidazole) is~     effective in patients with postgasrectomy syndrome~   "
106811|NCT01658839|"~     The purpose of this study was to assess the safety and describe the steady-state plasma~     pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation)~     following a once daily administration for 7 days in pediatric glaucoma or ocular~     hypertension patients.~   "
106812|NCT01658826|"~     The aim of the study is to evaluate the safety and efficacy of AIC316 (pritelivir) 100 mg~     once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital~     shedding.~   "
106813|NCT01658813|"~     The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU)~     and interferon, which is able to stimulate the immune system to kill cancer cells, will help~     to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or~     lung Cancer.~   "
106814|NCT01658800|"~     The purpose of this study is to test an investigational vaccine known as VAX161C. An~     investigational vaccine is one that is not licensed for commercial use in the by the~     United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for~     the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the~     subject will receive the VAX161C vaccine at one of six doses to see which dose is the best.~     VaxInnate wants to find out how safe these doses of vaccines are and how well they are~     tolerated by people who receive them. To measure how effective each type of the vaccine is,~     VaxInnate will test the ability of the body to develop an immune response, which means how~     the body recognizes and defends itself against the influenza virus.~   "
106815|NCT01658787|"~     Prospective, observational Registry to obtain data on device performance and clinical~     outcomes.~   "
106816|NCT01658774|"~     Many school children in Kenya are infected with plasmodia and helminth species and are at~     risk of coinfection. It has been suggested that the immune response evoked by helminth~     infections may modify immune responses to plasmodia species and consequently alter infection~     and disease risks. However, studies conducted to date have been typically cross-sectional~     and produced conflicting results, and there is a need for longitudinal studies to better~     understand the clinical consequences for individuals harbouring coinfection. This study aims~     to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus~     annual treatment on the risk of clinical malaria and on immune responses among school~     children aged 5-14 years in Western Province. Specifically, this study aims to investigate~     the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in~     school children, assessed using active case detection; (ii) the prevalence and density of~     Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and~     helminth specific immune responses. The study hypothesis is that intensive anthelminthic~     treatment among children infected with either Ascaris lumbricoides or hookworm modifies~     human host immune responses to plasmodia and helminth infections, and therefore alters the~     risk of Plasmodium infection and clinical disease.~      This individually randomised trial will recruit 1,450 children aged 5-14 years found to be~     infected with either Ascaris lumbricoides or hookworm species. Recruited children will be~     randomized to receive albendazole treatment either every three months or annually and~     monitored through periodic surveillance for clinical malaria episodes over 18 months. In~     addition, blood samples will be collected from sub-sample of children and screened for~     malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and~     IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor~     (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.~   "
106817|NCT01658761|"~     Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was~     evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether~     it may improve visual outcome.~   "
106818|NCT01658748|"~     The purpose of this study is to determine whether deep brain stimulation of the basolateral~     nucleus (BLn) of the amygdala, on both sides of the brain, can safely reduce symptoms of~     post-traumatic stress disorder (PTSD) in combat veterans whose condition has not improved~     despite extensive treatment with currently available medication and psychotherapy~     interventions.~   "
106840|NCT01658449|"~     The purpose of this study is to compare the tolerability and acceptability of a formulation~     containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic~     acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance~     to HS.~   "
106821|NCT01658709|"~     The objective of this study is to determine if a clinical measure can be used effectively to~     predict ankle injury in high school and collegiate athletes across a variety of sports.~      Hypothesis: For each ankle injury category (lateral ankle sprain, medial ankle sprain,~     syndesmosis ankle sprain, Achilles rupture, fracture) participants that suffer these~     injuries will have a significantly lower SEBT normalized composite score and FMS composite~     score compared to those participants that do not suffer the injury~      Hypothesis #1b: Similar to a previous study examining high school basketball players22,~     using receiver operator characteristic (ROC) curves, we will be able to calculate likelihood~     ratios, odds ratios, sensitivity and specificity and determine the ideal cut-off point of~     the SEBT normalized composite score and FMS composite score that will be able to predict the~     risk of each ankle injury category (lateral ankle sprain, medial ankle sprain, syndesmosis~     ankle sprain, Achilles rupture, fracture).~      Athletes from identified sites will perform measures of the star excursion balance test~     (SEBT) and the Functional Movement Screen FMS before the first day of practice. During the~     competition season, the number of practice and competition person exposures, as well as the~     number of ankle injuries, will be recorded. The rate of ankle injuries/exposure will be~     calculated and compared with the pre-season SEBT scores to create a simple and a complex~     prediction model for risk of ankle injury~   "
106822|NCT01658696|"~     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials~     become more widely available. However, transmission still persists and it appears that~     additional control measures are required. The leading malaria vaccine candidate in~     development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the~     field. This partial protection might be enhanced by combination with other components. The~     other vaccination approach that has produced repeatable efficacy in humans is the use of~     viral vectors to induce T cell responses. Previous attempts with this vaccine approach have~     been effective in challenge studies in Oxford, but ineffective in the field, probably~     because of reduced immunogenicity with previous vector platforms.~      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity~     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified~     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with~     thrombospondin- related adhesion protein (ME-TRAP).~      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and~     partial protection in 5 out of 14 volunteers in challenge studies.~      The investigators propose a Phase 2b study of 120 healthy adult men in Senegal. The~     investigators will assess the efficacy and further evaluate the immunogenicity and safety~     profile of the vaccine regimen. The investigators also intend to assess the correlates of~     efficacy and natural immunity.~   "
106823|NCT01658683|"~     The purpose of this study is to develop a new intervention to improve the transition of~     patients from structured, supervised exercise to self-managed home- or approved~     community-based exercise programs in an effort to increase maintenance of exercise behaviour~     post cardiac rehabilitation (CR). The goal of the study is that those receiving the~     intervention will engage in at least 30 minutes of physical activity at a moderate or~     vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those~     in the usual care group. The new intervention will be delivered by trained exercise~     facilitators (physiotherapists or exercise specialists) and will make use of: small group~     counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and~     community program demonstrations that would facilitate linkages between patients and~     approved community programs known as Heart Wise Exercise programs available in Ottawa and~     Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at~     the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and~     Prevention Centre at the University Health Network (Peter Munk Cardiac Centre [PMCC] and~     Toronto Rehabilitation Institute [TRI]) sites. The study has a target enrollment of 604~     participants.~   "
106824|NCT01658670|"~     The purpose of this study is to determine the efficacy of the Heart Failure Exercise and~     Resistance Training (HEART) Camp behavioral exercise training intervention on long-term~     adherence to exercise at 18 months in patients with heart failure. The central hypothesis is~     that the HEART Camp intervention group (HC) will have significantly better adherence to~     exercise at 18 months.~   "
106825|NCT01658657|"~     The purpose of this study is to investigate the effect of plasma renin activity-guided~     therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that~     can be measured to determine your hypertension subtype. Once the subtype is known, doctors~     can prescribe specific medications to target your specific hypertension subtype. This study~     will investigate whether targeting the specific hypertension subtype helps to achieve blood~     pressure control sooner and with fewer medications compared to a standard fixed dose~     combination therapy.~   "
106826|NCT01658644|"~     Communication is critical within healthcare, and is the root cause of most errors. With~     increased adoption and use of new information technologies and mediated communication~     systems, such as Electronic Health Records (EHR), that support visual content, hospitals can~     begin to look at the potential of photographic aids to improve patient satisfaction,~     clinician communication, and ultimately quality of care. Having pictures of clinicians and~     patients may improve communication by improving knowledge of who is part of the care team~     and may reduce electronic ordering or documentation on the wrong patient.~      Despite the importance of communication between clinicians and the many advances within~     information and communication technologies, there is a lack of literature documenting~     systems that are effective at improving communication. Our research study will provide an~     overview on the communication models and technologies used in Canadian hospitals and add~     insights to the impacts of these technological adoption.~      Research Question: How does the use of photographic influence patients' hospital experience?~      Specifically, do photographic aids (photographs of clinicians' faces) influence:~        1. Patient's ability to identify their clinical care team members~        2. Patient's ability to identify their care team members and know their individual roles~        3. Patient's satisfaction with their hospital experience~   "
106827|NCT01658631|"~     The purpose of this study is to compare the non invasive measurement of arterial pressure~     (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)~        -  during induction of general anesthesia,~        -  during a leg raising test in the Intensive Care Unit~   "
106851|NCT01658306|"~     The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a~     beneficial effect on outcomes of cerebral small vessel disease (CSV).~   "
106828|NCT01658618|"~     This observations safety study is intended for subject who participated in the~     802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and~     received at least one application of HP802-247 or Vehicle (an inactive substance). This~     study is being done for the following purposes:~        1. to identify new adverse events,~        2. to examine ongoing adverse events not resolved in subjects who participated in the~          802-247-09-029 trial,~        3. to record wound status, and~        4. to determine if there are differences in Health Related Quality of Life (HRQoL)~          associated with the treatment assignment from the 802-247-09-029 Trial.~      Investigational means that HP802-247 has not been approved by the U.S. Food and Drug~     Administration (FDA).~   "
106829|NCT01658605|"~     GSK1605786 is an oral antagonist specific for the chemokine receptor CCR9 in development for~     treatment of small bowel and colonic Crohn's disease (CD). The purpose of this Phase II~     proof of concept study is to investigate the efficacy and safety of GSK1605786 (500 mg twice~     daily) administered orally for 16 weeks for the treatment of patients with active ulcerative~     colitis (UC). A key secondary objective is to understand the mechanism by which GSK1605786~     is acting and to this end samples will be collected to confirm the degree of inhibition of~     CCR9 on T lymphocytes in the blood of patients, and to explore the relationship between~     concentration of drug and changes in lymphocyte and antigen presenting cell populations in~     the peripheral circulation and in the colon. Patients recruited at specified investigational~     sites will be invited to participate in an optional sub-study to explore the effects of~     GSK1605786 on trafficking of technetium labelled T cells using Single Photon Emission~     Computerized Tomography (SPECT). Specifically, the technique will be used to follow~     trafficking to large intestine and thymus and findings linked to pharmacokinetics of~     GSK1605786, receptor occupancy and clinical efficacy outcomes~   "
106830|NCT01658592|"~     The main objective of this study is to assess the efficacy of bilateral deep brain~     stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule~     (VC) as a novel treatment in severe alcohol addiction. The included patients have been~     treated so far with drugs that inhibits alcohol, or psychological behavior training.~      Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for~     alcohol and thus enable the patients to decrease their alcohol intake substantially.~   "
106831|NCT01658579|"~     Primary Objective:~        -  To compare the glucose control during treatment with a new formulation of insulin~          glargine and Lantus in adult participants with type 1 diabetes mellitus~      Secondary Objectives:~        -  To compare a new formulation of insulin glargine and Lantus given in the morning or in~          the evening~        -  To compare the incidence and frequency of hypoglycemic episodes~        -  To assess the safety and tolerability of the new formulation of insulin glargine~   "
106832|NCT01658553|"~     A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded~     study to evaluate the effect of GSK1120212 on the electrical activity of the heart as~     compared to placebo in subjects with solid tumor cancers. All subjects will undergo~     Screening assessments within 21 days prior to the start of the study treatment to determine~     their eligibility for enrollment in the study. Eligible subjects will receive study~     treatment administered over a period of 15 days followed by a post-treatment follow-up~     visit. Study treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects~     will receive GSK1120212-matched placebo on one day during the first 14 days of dosing. On~     all other days the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day~     15 when the subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be~     obtained from continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days~     1 and 15 while subjects are in the clinical research unit. The effect of GSK1120212 on the~     electrical activity of the heart will be determined by time-matched ECGs obtained at the~     same time points relative to dosing on these days. Ambulatory blood pressure readings will~     be obtained from continuous 24-hour recordings via an ambulatory blood pressure monitor The~     effect of GSK1120212 on blood pressure parameters will be determined by blood pressure~     readings obtained at the same time points relative to dosing on Study Days 1 and 15. Serial~     blood samples to analyze the concentration of study drug in the subject's blood will be~     obtained at the same time points relative to dosing on Study Days 1 and 15. Subjects who are~     eligible for continued treatment with GSK1120212 may continue treatment under the rollover~     study MEK114375 (drug study number). A post-treatment follow-up visit will be conducted~     within 28 days of the last dose of study treatment for all subjects who do not continue~     treatment in the rollover study MEK114375.~   "
106833|NCT01658540|"~     The primary purpose of this study is to assess safety and efficacy of the Drug Eluting~     Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic~     obstructive vascular disease in patients presenting with long lesions. As secondary aim this~     study is going to explore treatment effect on a number of procedural and clinical endpoints~     in order to collect information to design a future comparative effectiveness study.~   "
106834|NCT01658527|"~     The objective of this randomized phase II open label trial is to determine the anti-tumor~     activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical~     progression-free survival in prostate cancer patients who failed 1st line treatment with~     LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.~   "
106835|NCT01658514|"~     This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in~     subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction,~     or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In~     addition, this study compared the behavior of a single dose of Met DR with that of~     extended-release metformin (Met XR) and placebo in subjects with the varying levels of~     kidney function described above.~   "
106836|NCT01658501|"~     Primary objective:~      The primary objective of this study is to define the dose response of Glymera as measured as~     the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.~      Secondary objectives:~      The secondary objectives are to:~        -  Describe incidence, severity, and duration of reported gastrointestinal side effects of~          Glymera compared to active comparator;~        -  Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo~          and active comparator;~        -  Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of~          dosing compared to placebo and active comparator;~        -  Describe the frequencies of adverse events in the treatment groups; and~        -  Describe the above endpoints for the following subgroups of subjects according to~          baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin~          only, sulfonylurea only, or metformin and sulfonylurea combination therapy.~   "
106837|NCT01658488|"~     The purpose of this study is to see if rice enriched in iron will help women with~     iron-deficient anemia restore their blood counts more efficiently than the standard rice not~     enriched with iron.~   "
106838|NCT01658475|"~     This study was performed to evaluate prospectively the diagnostic utility of a blood IgG~     antibody titer test against periodontal pathogens.~   "
106839|NCT01658462|"~     National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy /~     Second-line chemotherapy for locally recurrent or metastatic breast cancer.~   "
106841|NCT01658436|"~     This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC)~     versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET)~     after failure of mTOR inhibitor therapy.~      Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single~     arm, open label design and Stage 2 was planned to be a randomized, double-blind study.~      However, at the end of Stage 1, the futility was met and hence the Stage 2 was not~     initiated.~   "
106842|NCT01658423|"~     The current study examined the effect of maturity on the sprint and jump performances in a~     single year age group of 13 year old boys.~   "
106843|NCT01658410|"~     Background: Although selected cardiac surgery can be performed off-pump, the vast majority~     of cardiac surgical procedures today are performed with the support of cardiopulmonary~     bypass (CPB). Blood cardioplegia is used to protect the heart during aortic cross-clamping.~     However, negative effects of myocardial hypoxia during surgery are often aggravated by~     ischemia/reperfusion injury. In addition, cardiopulmonary bypass leads to an inflammatory~     response including endothelial cell activation.~      Comparable to the reperfusion injury following acute myocardial infarction resolved by~     percutaneous coronary intervention, the microcirculatory impairment observed after cardiac~     surgery may be caused by endothelin 1 (ET-1). ET-1 is a potent vasoconstrictor peptide~     upregulated in myocardial ischemia-reperfusion injury. Short-term administration of the~     selective ETA receptor blocker BQ-123 was found safe in a pilot study including patients~     with acute myocardial infarction.~      Hypothesis: Acute local ETA receptor blockade by intracoronary administered BQ-123 reduces~     myocardial injury.~      Methods: BQ-123 will be administered in patients undergoing on-pump aorto-coronary bypass~     grafting to the left anterior descending coronary artery with the use a left inner mammary~     artery graft and at least one vein graft. Subjects will be randomized to receive the~     endothelin-A receptor blocker BQ-123 or placebo administered intracoronarily in combination~     with cardioplegia in a double-blind manner. The primary endpoint will be enzymatic infarct~     size.~      Clinical perspective: The implementation of BQ-123 as an add-on pharmacologic therapy in~     cardiac surgery performed with the use of cardiopulmonary bypass could lead to improved~     tissue reperfusion and reduced ischemia/reperfusion injury, potentially impacting clinical~     long-term outcome.~   "
106844|NCT01658397|"~     In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast)~     on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in~     bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure~     subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will~     increase after an acute fast.~   "
106845|NCT01658384|"~     This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis~     (MS) patients. During a period of 24 months, the study will assess the evolution of~     cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test~     (SDMT) and the CogState battery of tests.~   "
106846|NCT01658371|"~     Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients.~     The investigators investigate the prevalence of genetic polymorphism affecting efavirenz~     metabolism and the corresponding pharmacokinetics of different genotypes.~   "
106847|NCT01658358|"~     Objectives:~      Phase I part~        -  Primary Objective: To determine the recommended dose of the combination of lapatinib~          with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic~          breast cancer.~        -  Secondary Objectives:To define the safety profile; To observe the response rate and~          progression free survival~      Phase II part~        -  Primary Objective :To determined the objective response rate of the combination of~          lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive~          metastatic breast cancer.~        -  Secondary Objectives:To define the safety profile; To determined the progression free~          survival~   "
106848|NCT01658345|"~     Aortic stenosis (AS), or narrowing of the aortic valve, is the commonest condition requiring~     valve surgery in the developed world. It is currently not known what determines who will go~     on to develop symptoms. Exercise testing may be able to identify these patients better than~     the severity of the narrowing itself, but with some limitations.~      The purpose of this study is to compare whether MRI scanning or exercise testing can better~     identify patients with AS who are likely to benefit from surgery.~      Design: The investigators will measure blood flow to the heart muscle with MRI scanning and~     perform exercise testing in 170 patients with AS and follow them for up to up to 2 years.~     Expected outcomes: MRI scanning will more accurately identify those patients with AS who~     will need surgery during this period. Anticipated Health Benefits: improved selection of~     patients with AS who are likely to benefit from early surgery. This is likely to reduce~     deaths in such patients.~   "
106849|NCT01658332|"~     TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer~     (CIRCUBRONCH)~      BACKGROUND : Circulating tumor cells identification is a new field of research in oncology,~     and some studies have been conducted with success on breast and prostate cancer. Nearly 80%~     of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells~     identification and monitoring these cells after treatment could help the clinicians to~     detect relapse or be a prognostic factor.~      PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage~     lung cancers (IIIB and IV).~      SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the~     therapeutic response. Prognostic value of identification of circulating tumor cells at the~     time of diagnosis.~      STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification~     of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.~      Duration of the inclusions: 54 months.~      Duration of the study: 66 months.~      PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a~     cut-off of 5 cells/7,5 ml of blood.~      SAMPLE SIZE : 200 patients~      STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage~     IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5~     circulating tumor cells per 7,5 ml of blood.~   "
106850|NCT01658319|"~     This phase I trial is studying the side effects and best dose of methoxyamine when given~     together with fludarabine phosphate in treating patients with relapsed or refractory~     hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine~     phosphate, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving methoxyamine together with fludarabine~     phosphate may kill more cancer cells.~   "
106852|NCT01658293|"~     Sensory and/or motor deficits in upper limb following stroke often have negative impacts on~     their daily living. Thermal stimulation with hot and cold pack alternatively incorporated~     into conventional rehabilitation has been reported and proved to be effective for upper limb~     functional recovery after stroke. However, whether hot- and cold-water stimulation~     alternatively based on thermal stimulation also has the effect still remains unknown. The~     aim of present study is to investigate the facilitated effect of hot and cold water~     stimulation alternatively on upper limb after stroke.~   "
106853|NCT01658280|"~     The main purpose of the present study is to assess whether the sensitivity of~     Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of~     conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.~   "
106854|NCT01658267|"~     This study will assess compliance with dietary recommendations, in conjunction with a~     nutritional supplement to meet the nutritional requirements in children and the effects of~     the compliance on promoting growth in children who are at risk of under-nutrition.~   "
106855|NCT01658254|"~     The gap between the high number of registered trials and the few ones where results were~     available (in registries or in journals) has been identified as a major problem distorting~     the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration~     Amendments Act) added on September 27, 2007 a requirements policy regarding publication of~     summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary~     results is required for applicable clinical trials no later than one year after the~     primary completion date, i.e. the date of collection of primary outcome data on the last~     patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to~     designate trials that may be subject to the registration and reporting requirements.~      Not complying with the reporting requirements can result in penalties, such as withholding~     of National Institute of Health grant or funding and civil monetary penalties of up to~     $10,000 a day. Despite the possibility of incurring penalties for not complying with the~     posting requirement, compliance remains globally poor.~      In this current study, the primary objective will be to test the hypothesis that sending an~     email looking as a survey, reminding the necessity of posting results to the trials'~     responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but~     not complying with it, will increase the results posting rate.~   "
106856|NCT01658241|"~     This study is looking at the effects of Panobinostat, an investigational treatment, on~     cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with~     specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with~     too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune~     system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune~     system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).~      Panobinostat is a new drug which has led to disease improvement in some patients with~     Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not~     all patients benefit from panobinostat.~      The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this~     project is find out which patients or diseases are likely to respond to treatment with~     panobinostat in the future and to see if there are particular features of the patient or of~     the cancer that affects the likelihood of the way individuals respond to panobinostat.~      Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in~     normal cells make proteins. Panobinostat has been used in several clinical trials around the~     world. The largest trials generally have fewer than 200 patients and are in Hodgkin~     lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three~     patients have significant improvement in their disease.~      Researchers will look at samples of tumour before treatment and during treatment. This will~     be one of the first studies to look at how cancer cells change following treatment with this~     drug. It is unusual because it requires repeated biopsies of the participant's tumour.~     Panobinostat is considered an experimental (or investigational) drug and not approved by any~     regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the~     Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer.~     Therefore, Panobinostat is not approved to treat patients who have been diagnosed with~     refractory or relapsed cancer.~      A total of 30 patients with one of the diseases listed above will be enrolled at Peter~     MacCallum Cancer Centre.~      It is expected it will take about 2 to 3 years to recruit 30 patients and that on average~     patients will take part for six to eighteen months. This time could be shorter or longer~     depending on how well the treatment works in each individual. While the trial will take up~     to 4 years to complete, the science studies may take longer.~   "
106857|NCT01658228|"~     Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique,~     understudied population that is difficult to diagnose, treat and estimate prognosis. Our~     pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive~     decline and often convert to dementia, primarily Alzheimer's disease (AD). In DEP-CI, there~     is a lack of data on treatment response of mood symptoms to antidepressant treatment and~     particularly of cognitive deficits to cognitive enhancer treatment. Our initial pilot data~     in a double-blind study showed that donepezil was superior to placebo in improving memory in~     antidepressant-treated DEP-CI patients. In a second pilot study, open label es-citalopram~     plus memantine treatment led to a low rate of conversion to dementia.~      In this proposed pilot clinical trial, the investigators will evaluate, treat and follow a~     broad sample of 80 DEP-CI patients at NYSPI/Columbia University Medical Center (N = 40) and~     Duke University Medical Center (N = 40). Recruitment will be from clinics and/or~     advertisements. In the treatment protocol, all 80 DEP-CI patients will receive baseline mood~     and memory assessments and open antidepressant treatment with citalopram for 8 weeks. At 8~     weeks, repeat assessment will occur and patients whose depression has responded to~     citalopram will be randomized to add-on donepezil or placebo. Non-responders to citalopram~     will receive open treatment with venlafaxine and will be randomized 8 weeks later (16 weeks~     of open antidepressant treatment) to add-on donepezil or placebo. Patients will be followed~     for a total period of 18 months with continuous open antidepressant treatment during the~     trial.~      Donepezil is being studied in order to increase the likelihood of obtaining a signal. If the~     results are positive, the investigators can begin clarifying the mechanism(s) in subsequent~     trials. Baseline apolipoprotein E e4 genotype, odor identification deficits, and MRI~     hippocampal and entorhinal cortex atrophy will be explored as predictors of donepezil~     response in the 18-month trial. Improving cognition and delaying conversion to a clinical~     diagnosis of dementia in this high risk group will enhance quality of life, reduce family~     burden, and markedly diminish overall health care costs.~   "
106858|NCT01658215|"~     The purpose of this study is to compare the relative bioavailability of nicotine following~     repeated applications of a new transdermal formulation to that of a reference formulation.~      Up to day 7~   "
106859|NCT01658202|"~     The purpose of this study is to compare the relative bioavailability of nicotine following~     single application of a new transdermal formulation to that of a reference formulation.~      4 single 24hour applications separated by 48hour intervals.~   "
106860|NCT01658176|"~     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor~     for the treatment of advanced breast cancer in women whose disease has progressed following~     tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance~     to hormonal therapy and result in greater clinical benefit than exemestane alone in women~     with estrogen receptor positive advanced breast cancer.~   "
106861|NCT01658163|"~     The investigators prospectively studied the results of wound closure after abdominoplasty~     with randomized use of PrineoTM and conventional suturing to assess the possible difference~     in outcome between these two methods.Follow-up visits to the outpatient clinic were~     scheduled at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three~     plastic surgeons and three plastic surgery residents assessed the wound and scar appearance~     during the three follow-up visits.~   "
106862|NCT01658150|"~     The purpose of this study is to evaluate the use of the drug isradipine for cognitive~     enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.~   "
106863|NCT01658137|"~     Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids,~     blood pressure, obesity, diabetes, and may also influence dietary choices, physical~     activity, and responses to stress. The most robust genetic variant associated with~     myocardial infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40%~     in those who carry 2 copies of the gene. The investigators recently found that among those~     who carry the 9p21 variant, the risk of MI may be turned off if individuals eat a diet~     high in fruits and vegetables. The investigators seek to determine how a prudent or~     anti-inflammatory diet interacts with the 9p21 risk allele to alter the risk of MI.~   "
106864|NCT01658124|"~     Severe bleeding in the digestive system is a common symptom of many diseases. Each year,~     about 50,000 people end up in British hospitals because of this problem and about 5,000 of~     them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa,~     schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach~     bleeding each year. From previous research in other bleeding conditions such as surgery and~     trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We~     now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if~     there are any complications in people with severe bleeding from the digestive system.~   "
106865|NCT01658111|"~     Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions~     on conditions leading to long-term disability, such as stroke, is a complex task because the~     outcome depends on many interacting factors. Several studies underline the importance of~     brain plasticity and its therapeutic potential in neurological disorders. Accredited~     theories of cortical reorganization after brain lesion endorse the use of early, intensive,~     repetitive, and context-related exercise as optimal strategies to promote motor relearning~     and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation~     programs has been already demonstrated to provide safe and intensive treatment to subjects~     with motor impairments due to a neurological injury: several studies showed the advantages~     of robotic therapy on chronic post-stroke patients, even if no consistent influence on~     functional abilities was found and evidence of better results providing intensive~     treatments, both robotic and conventional rehabilitative techniques, was found. Recent~     development and recent trial in robot-assisted rehabilitation has shown the great potential~     of robotic devices for delivering repetitive training, thus facilitating a high intensity~     and a large dose of training during sub-acute and chronic phases of stroke rehabilitation.~     The proposed project, through a randomized controlled observer-blind multicenter trial is~     aimed at evaluating the effectiveness of robot-assisted therapy as additional treatment to~     the standard physical therapy in the early phase after stroke onset and evaluating in~     conjunction with EEG and EMG recordings the effects of the rehabilitative treatments in a~     quantitative, measurable way, by providing reliable and objective methods for measuring~     functional recovery after stroke.~   "
106866|NCT01658098|"~     This research will use the Edinburgh Scale Of Post partum depression to evaluate patients~     during their 4th to 6th after delivery, and the investigators will compare the results with~     those found in other countries with population with similar characteristics as ours~   "
106867|NCT01658085|"~     Study Design Multinodular Goiter (MNG) patients requiring surgery were referred to the~     Endocrine Surgery Unit.~      Indirect laryngoscopy was routinely performed preoperatively to assess normal motility in~     vocal folds (VF). Ultrasounds (US) study was performed the month previous to surgery to~     evaluate thyroid volume. Eligible patients met the following criteria: to have MNG, age~     between 18 and 80 and consent to be included in the study. Exclusion criteria included~     previous neck surgery, vocal fold impairment, permanent or transitory NSAID or analgesic~     treatment, coagulation disorders and any cognitive impairment.~      Eligible patients were proposed to enter a randomized study with 2 arms in which we compared~     the use of two harmonic scalpel devices: ACE14S and Harmonic Focus (Ethicon Endo-Surgery,~     Cincinnati, OH, USA).~      The main endpoint was operative time. Secondary endpoints were total and relative (%) time~     of use of the device along thyroidectomy, recurrent laryngeal nerve (RLN) injury and~     hypocalcaemia (both persistent or temporary), number of ligatures, length of skin incision,~     postoperative pain according to a visual scale of pain, QOL after thyroidectomy (EuroQOL)~     and budget impact analysis.~      All patients were operated on by 2 surgeons, one senior (responsible for the Endocrine~     Surgery Unit) and one junior under supervision.~      Randomization Randomization was performed the same day of surgery at the OR by using a~     closed envelope. Patients were randomized to Group I (ACE14S) or Group II (HF) and allocated~     in a 1:1 proportion; they reminded blinded until the end of the study about the device used.~      The haemostasis device was communicated to the surgeon previous to start surgery. Medical~     staff of the Endocrine Surgery Unit collected clinical data.~      Surgical Technique Total thyroidectomy (TT), defined as total bilateral extracapsular~     lobectomy 9, was performed using HF or ACE14S for vessel division. Monopolar and bipolar~     forceps for cutting and coagulation were routinely used. Ties were used under surgeon's~     criteria according to size of the vessels and/or the need to obtain haemostasis in the~     vicinity of the RLN when bipolar forceps were not considered safe enough.~   "
106868|NCT01658072|"~     The best way to provide analgesia after total hip arthroplasty is hotly debated. There are~     two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their~     proponents, but there are limited data for making an informed choice of protocols. For total~     hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with~     physical therapy. However, epidural analgesia can be associated with nausea, pruritis,~     dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may~     prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided~     to use a different analgesic protocol, based on a peri-articular injection. This protocol~     avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as~     part of a multimodal pain therapy. The investigators propose to compare peri-articular~     injection to epidural patient controlled analgesia (Epidural PCA). The investigators will~     enroll 90 total patients (45 per study arm). The enrollment period will be approximately one~     year and the duration of the follow-up with study patients will be three months following~     their procedure.~   "
106869|NCT01658059|"~     Pharmacological interventions to aid behavior management's techniques are commonly used in~     pediatric dentistry. The aim of the medicaments is to control behavior and allow safe~     completion of a dental procedure. Homeopathic remedy is safe and can be effective to control~     behavior and decrease anxiety in children during dental treatment.~      Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety~     before dental treatment.~      2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for~     anxious children.~      Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will~     receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be~     measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS),~     and Houpt behavior scale.~      Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation~     during dental treatment.~   "
106870|NCT01658046|"~     Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in~     chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized~     controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus~     quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training~     (control group) on muscle function, exercise capacity, health related quality of life,~     activities of daily living, and self-efficacy in patients with COPD who are eligible and~     able to participate in endurance training.~   "
106871|NCT01658033|"~     The objective of this phase II study is to evaluate efficacy and safety of avastin plus~     modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five~     patients will be enrolled into this study.~   "
106872|NCT01658020|"~     The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple~     dose of Zabofloxacin Tablet 400 mg.~   "
106873|NCT01658007|"~     The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia~     and lymphoma with a drug called sirolimus. The investigators are using sirolimus along with~     other cancer drugs that are often given to patients with relapsed leukemia and lymphoma.~      The main purpose of this study is to determine if sirolimus can be given safely in~     combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.~   "
106874|NCT01657994|"~     The purpose of this research study is to learn more about the usefulness of a physical~     therapy treatment that combines robot-assisted walking with electrical impulses that help to~     make muscles contract. This treatment is intended for children with cerebral palsy. Up to~     eleven children with cerebral palsy will receive up to 18 treatments and will have several~     evaluations before and after treatment.~   "
106875|NCT01657981|"~     The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with~     a radio labeled drinking solution.~   "
106876|NCT01657968|"~     The primary purpose of the present study is to investigate the usefulness of Procalcitonin~     as a supplement to the Streptococcal antigen test and Centor criteria in the differential~     diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.~      Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute~     tonsillitis due to Fusobacterium Necrophorum.~   "
106877|NCT01657955|"~     The purpose of this study is to determine whether bendamustine is effective in the treatment~     of initial treatment of Chronic Lymphocytic Leukemia (CLL).~   "
106878|NCT01657942|"~     The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential~     to be an effective non-invasive treatment for low to intermediate risk, organ-confined~     prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by~     measuring treatment-related safety and initial effectiveness parameters in the ExAblate~     MRgFUS treated patients, as described above.~   "
106879|NCT01657929|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant~     influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based~     expression system assembling into virus-like particles together with the adjuvant GLA-AF.~   "
106880|NCT01657916|"~     Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align~     Urethral Support System.~   "
106881|NCT01657903|"~     The purpose of this study is to compare and evaluate the ability of two European Union (EU)~     regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a~     modified in-situ model of dental erosion and remineralization. A positive control i.e~     fluoride containing toothpaste marketed in EU will also be compared to non-fluoride~     toothpaste.~   "
106882|NCT01657890|"~     The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy~     non-elderly and elderly male and female subjects.~   "
106883|NCT01657877|"~     In situ study to compare treatment effect on enamel remineralization potential, measured by~     surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will~     explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice~     containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only~     dentifrice.~   "
106884|NCT01657864|"~     The objective of the study is to quantify the number of cases of aseptic meningitis among~     users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine~     patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database).~     The MarketScan database is a US-based insurance claims database representative of a US~     insured population and includes supplemental datao n Medicare patients. This cross-sectional~     study will evaluate the number of cases of aseptic meningitis among lamotrigine users during~     the duration of lamotrigine therapy, with an extended exposure window of 30 days after~     completing therapy.~      The MarketScan® Database is an US insurance claims database that is held in-house at GSK,~     which can be interrogated to examine rates of prescribing and medical conditions that can be~     captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific~     clinical utilization, expenditures, and enrollment across inpatient, outpatient,~     prescription drug, and carve-out services from a selection of large employers, health plans,~     and government and public organizations. The annual medical databases include private sector~     health data from approximately 100 payers. In 2011, there were approximately 35 million~     patients on the database. The Commercial Claims and Encounters Database represents the~     medical experience of insured employees and their dependents for active employees, early~     retirees, COBRA continues, and their dependents insured by employer-sponsored plans (i.e.,~     non-Medicare eligibles). In addition, a linked Medstat Medicare database contains~     predominantly fee-for-service plan data in insurance plans where both the Medicare-paid~     amounts and the employer-paid amounts were available and evident on the claims.The data are~     HIPAA compliant thus all patients have been anonymized.~   "
106885|NCT01657851|"~     Open-label, randomized, single dose, two-treatment, two-way crossover study~   "
106886|NCT01657838|"~     The purpose of this study is to assess the effect of ketoconazole at steady state on the~     pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.~   "
106887|NCT01657825|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of warfarin after single dose administration.~   "
106906|NCT01657578|"~     The principal aim of this trial is to determine the minimum effective dose of omeprazole in~     neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring~     (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24~     after initiation of omeprazole.~      The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon~     other pHmetry parameters, (2) to characterize the population pharmacokinetics and~     pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal~     pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates.~   "
106888|NCT01657812|"~     Clinically, combining epidural with general anaesthesia may confer many advantages to~     patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia~     can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis,~     spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However,~     establishing epidural anesthesia is not without risks and contraindications, including~     refusal by the patient, technical failure, unintentional dural puncture, waist and back pain~     and local anaesthetic toxicity. When neurologic complications do occur, the resulting~     morbidity and mortality is considerable. Dexmedetomidine is a potent α2-adrenoceptor agonist~     with an 8 times greater affinity for α2-adrenoceptors than clonidine. This class of agent is~     known to have sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing~     effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and~     attenuate the stress response associated with surgery.1 Unlike epidural anaesthesia,~     dexmedetomidine is easy to administer and no potential for neurological damage. The~     investigators hypothesize that the dexmedetomidine reduces the stress response of surgery to~     the similar extent to epidural anaesthesia when used in conjunction with a standard general~     anaesthesia for abdominal surgery.~   "
106889|NCT01657799|"~     The primary objective of this study is to evaluate the Overall Survival, Best Tumor Response~     Rate, Time to Intracranial Progression (radiographic), Time to Clinical Brain Metastasis~     Progression, safety, and tolerability of veliparib and Whole Brain Radiation Therapy in~     subjects with brain metastases from Non Small Cell Lung Cancer~   "
106890|NCT01657786|"~     Postoperative nausea and vomiting (PONV) is a common and distressing complication in~     patients undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3)~     receptor antagonists have significantly reduced PONV, it is reported that over 35% of~     patients treated with ondansetron experience PONV. Though the cause of failure in~     ondansetron treatment is not clear, the investigators assumed that polymorphism in the 5-HT3~     receptor gene would contribute to such inter-individual variation. In this study, the~     investigators examine whether the polymorphisms of 5-HT3 receptor gene affect the efficacy~     of ondansetron to prevent PONV in patients undergoing general anesthesia for laparoscopic~     surgery.~   "
106891|NCT01657773|"~     The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients~     with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor~     for CRC.~   "
106892|NCT01657760|"~     Alcohol use disorders (AUDs) are highly prevalent among U.S. civilians, and even more~     prevalent in the U.S. Veteran population. AUDs are frequently co-morbid with depressive~     symptoms in psychiatric clinical populations, resulting in an increased severity of both~     conditions. Indeed, returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)~     Veterans have extraordinarily high rates of alcohol misuse and co-morbid psychiatric~     symptoms, indicating that future Veteran clinical populations will be particularly affected~     by AUDs. While FDA-approved medications are available to treat AUDs, their efficacy is low~     compared to available psychosocial treatments. Despite the lack of evidence for efficacy~     from controlled trials, antidepressants are frequently prescribed to clinical populations~     (including Veterans) with active AUDs. A better understanding of patient-level clinical~     variables that may confer poor response to treatment with antidepressants would allow~     clinicians better tools to distinguish those alcohol-dependent Veterans likely to do worse~     with antidepressant treatment.~   "
106893|NCT01657747|"~     The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a~     non-invasive method for~        -  accurate staging of patient suspected having ovarian cancer~        -  early treatment assessment~        -  detecting tumor recurrence~   "
106894|NCT01657734|"~     Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal~     treatment. Hence, there is a clear need for new, effective therapies, among which immune~     therapy has emerged as a promising treatment option.~      When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often~     confronted with images that are difficult to interpret with the conventional anatomical~     imaging techniques. The difference between tumour relapse and therapy-mediated changes is~     not always distinctive.~      In this project, the investigators attempt to characterize the inflammatory response with~     parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and~     MR-diffusion imaging. These techniques allow characterization of cellular properties like~     metabolism and tissue structure respectively. Doing so, the investigators will monitor~     disease evolution in order to timely detect treatment failure, thereby allowing appropriate~     switch in patient management.~   "
106895|NCT01657721|"~     The overall objective of the current study is to determine whether computerized Working~     Memory (WM) training will enhance WM capacity in college students with Attention Deficit~     Hyperactivity Disorder (ADHD). There are also four additional objectives. The first is to~     investigate whether the program's efficacy is impacted by the duration of the daily training~     sessions. The second is to determine whether improvements in WM will generalize to secondary~     outcome tasks, such as inhibitory control and planning. The third objective is to examine~     whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The~     last objective is to investigate whether improvements will be maintained at a two month~     follow-up period. The investigators will also be assessing healthy control participants,who~     will not be receiving treatment, but will be used as a basis of comparison with the ADHD~     participants,~      It is expected that the computerized WM training program will enhance WM capacity in college~     students with ADHD. In addition, it is believed that these increases in WM capacity will~     also lead to improvements in other executive functions. It is also hypothesized that WM~     training will lead to a reduction in ADHD symptomology. Lastly, these improvements should be~     maintained at three month follow-up.~   "
106907|NCT01657565|"~     Introduction: An increasing proportion of childhood appendicitis is treated with~     laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of~     childhood appendicitis treated primarily by residents in a university hospital.~      Material and methods: All children (age<16 years) treated surgically with appendectomy in~     our department between January 2006 and January 2011 were retrospectively identified.~     Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were~     considered as non-satisfactory outcomes.~   "
106938|NCT01657162|"~     The purpose of this study is to provide 24 months of standard of care data on subjects~     previously enrolled in study BA058-05-003.~   "
106896|NCT01657708|"~     Background:~      Shared Decision Making (SDM) refers to a process of health care delivery in which~     practitioners and clients seeking help with decisions, collaborate to access relevant~     information and enable client-centered selections of health care resources (1, 2). SDM leads~     to better treatment adherence and outcomes for people with a medical problem (3). SDM~     principles have previously been used in psychiatry to improve antipsychotic and~     antidepressant medication adherence (4, 5); however, these principles have yet to be applied~     to psychiatric rehabilitation (6).~      The current research uniquely aims to test the development and implementation of a SDM~     intervention for people with psychotic spectrum disorders (e.g., schizophrenia and affective~     disorder) during the referral process to psychiatric rehabilitation services. The study will~     be conducted this year using a randomly selected sample from the population of people with~     psychotic spectrum disorders hospitalized in SHALVATA psychiatric hospital in Israel. It~     aims to facilitate better treatment and rehabilitation outcomes. It has received the support~     and approval of the Mental Health Division of the Ministry of Health (MOH) in Israel, the~     institutional review board (IRB) by the university of Haifa, Israel and a Helsinki committee~     approval by SHALVATA psychiatric hospital and the MOH in Israel.~      References~        1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What~          does it mean?(or it takes at least two to tango). Soc Sci Med. 1997;44(5):681-92.~        2. Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment~          Health J. 2006;42(1):87-105.~        3. Joosten EAG, DeFuentes-Merillas L, De Weert GH, Sensky T, Van Der Staak, C. P. F., De~          Jong, C. A. J. Systematic review of the effects of shared decision-making on patient~          satisfaction, treatment adherence and health status. Psychother Psychosom.~          2008;77(4):219-26.~        4. Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish~          to be involved in decisions about their medical treatment? Am J Psychiatry.~          2005;162(12):2382.~        5. Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision~          making for in-patients with schizophrenia. Acta Psychiatr Scand. 2006;114(4):265-73.~        6. Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health.~          Psychiatr Rehabil J. 2010;34(1):7-13.~   "
106897|NCT01657695|"~     Our long-term objective is to develop a new tool based on a (molecular-biology) integrated~     imaging technology able to characterize and categorize hepatocellular carcinoma (HCC)~     patients in need of liver transplant (LT). To this end, our study aims at correlating~     specific imaging traits and fractional growth of individual tumors collected over a~     restricted time frame (T0 and at week 7 after first tumor detection), with a molecular~     signature, obtained by custom microarray, histochemical and cytokine analysis. This should~     allow us to translate a series of purely morphologic information into a meaningful~     pathobiologic data sets. Validation of the integrated molecular-imaging tool will be~     performed prospectively by correlating the imaging-molecular data with HCC outcome in term~     of survival and disease-free survival after down staging procedures.~   "
106898|NCT01657682|"~     This pilot Phase II study is designed to evaluate the efficacy and tolerability of~     crenolanib in two cohorts of AML patients with FLT3 activation mutations (patients whose~     leukemia has recurred after prior chemotherapy not including a FLT3 TKI and patients whose~     leukemia has progressed after prior therapy with a FLT3 TKI).~   "
106899|NCT01657669|"~     This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection~     administered in subject who have active choroidal neovascularization due to Age Related~     Macular Degeneration (AMD).~   "
106900|NCT01657656|"~     Hypothesis~      That improving vitamin D status among TB patients will speed the pace of bacteriological~     cure, and will enhance immune responses to TB infection~   "
106901|NCT01657643|"~     The main purpose of the study is to find out if probiotics (healthy bacteria found in~     yogurt) can improve the health-related quality of life (HRQL) during upper respiratory~     infections (like the common cold) in college students living in residence hall on-campus at~     Framingham State University (Framingham, MA) who are randomized to receive a probiotic or~     placebo candy daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of~     quality of life (i.e., one's satisfaction with their life) that related specifically to a~     person's health (for example, ability to carry out normal daily activities). The~     investigators hypothesize that HRQL during URIs will be significantly higher in the~     probiotic groups compared to the placebo group. The proposed study will also seek to address~     the following secondary objectives: missed school and work days due to a upper respiratory~     infection.~   "
106902|NCT01657630|"~     This is an open, prospective, descriptive study aiming to evaluate the change in treatment~     satisfaction of primary care givers of young children who use the Accu-Chek Combo System.~     Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System~     on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment~     Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a~     distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes~     related therapeutic information will be collected and data about the use of the device~     components will be downloaded from the Accu-Chek Combo System~   "
106903|NCT01657617|"~     It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a~     significant problem. Conventional radiation therapy techniques have limitations for the dose~     that can be delivered to a chest tumor mass due to the adjacent dose limiting organs.~     Mounting evidence supports the use of hypofractionated stereotactically delivered radiation~     therapy to control lung cancer with acceptable toxicity profiles.~      Thus the investigators propose to increase the doses of radiation to residual masses of NSCL~     to a BED > 100 Gy by the addition of two fractions of stereotactically delivered boost~     radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy~     in 180 cGy fractions. Using the linear quadratic equation to model doses of radiation~     therapy, 59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body~     radiation therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition~     of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would~     theoretically result in higher degrees of local control of lung cancer masses, achieving a~     minimum cumulative BED of approximately 110Gy-equivalent.~   "
106904|NCT01657604|"~     Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation~     of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to~     recurrence of disease in the majority of patients. The trial aims to improve treatment~     strategies in CML by improving induction therapy and deescalating maintenance therapy using~     low dose IFN as inducer of immunosurveillance. The trial will provide important data on the~     duration of active therapy in CML patients. Considering the rapidly increasing prevalence of~     CML this is of individual but also socioeconomic importance.~   "
106905|NCT01657591|"~     This is a multi-cohort, dose-escalation study of XL888 with a fixed dose of vemurafenib. New~     dose escalation or de-escalation cohorts will be assigned by the Principal Investigator (PI)~     with discussion with appropriate co-investigators once safety and tolerability is known for~     a given cohort in accordance to dose escalation rules. Participants will be defined to be~     enrolled within a cohort upon receipt of first dose of XL888/vemurafenib.~   "
106908|NCT01657552|"~     The purpose of the current Phase I, open-label, three-period, single sequence, crossover~     study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag~     (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this~     study there will be a screening visit, three treatment periods, and a follow-up visit. In~     Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK)~     sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days~     with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with~     BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up~     visit within 10 to 14 days of the last dose of study drugs. The total duration of the study~     from Screening to Follow-up will be approximately 9 weeks.~   "
106909|NCT01657539|"~     Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp.~     lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms~     of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment.~     Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be~     performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the~     volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt~     which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4~     weeks, respectively. Experimental samples of saliva and biofilm will be collected from each~     participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric~     microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values~     before and after the treatment will be compared with Wilcoxon's test (p<0.05).~   "
106910|NCT01657526|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in~     humans.~   "
106911|NCT01657513|"~     TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are~     well-tolerated with few side effects.~      Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some~     do not respond at all while others respond initially but gradually lose effect despite~     increased dose and more frequent administration.~      The cause of treatment failure is largely unknown and it may be production of tnf-alfa~     neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis~     and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.~   "
106912|NCT01657500|"~     The purpose of this study is to compare the success of storing a donor cornea in Optisol GS,~     the current standard vs. storing the donor cornea in Life4°C, a newer solution. The donor~     cornea to be used for EK will be provided by an eye bank and will have been stored in either~     an Optisol GS solution or a Life 4°C solution. At 6 months, the doctors will determine~     whether there are any comparable differences in cell loss and graft clarity between the two~     donor corneas.~   "
106913|NCT01657487|"~     This study is to investigate and compare treatment efficacy with high and medium dose of~     fluticasone in combination with salmeterol in COPD patients.~   "
106914|NCT01657474|"~     The purpose of this study is to determine whether a weekly application of EpiFix human~     amniotic membrane is more effective than a biweekly application (every two weeks) in the~     treatment of diabetic foot ulcers.~   "
106915|NCT01657461|"~     This study is to determine if patients experiencing an Acute Ischemic Stroke due to large~     vessel occlusion, treated with combined IV t-PA and Solitaire FR within 6 hours of symptom~     onset have less stroke-related disability than those patients treated with IV t-PA alone.~   "
106916|NCT01657448|"~     The purpose of this study is to evaluate the efficacy of the combination of Methenamine +~     Methylthioninium chloride compared to phenazopyridine (comparator product) in the~     symptomatic relief of dysuria.~   "
106917|NCT01657435|"~     This study is intended to gather medium (0-5 years) and long-term (6-10 years) information~     regarding the performance and safety of the commercially available Ceramax™ Ceramic on~     Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up~     phase and a clinical outcomes phase.~      In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered~     for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective~     evaluations and radiographs will be completed annually.~      In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey~     will be mailed to subjects annually.~   "
106918|NCT01657422|"~     PACE+ was developed to address the increased number of adolescents in our country that are~     at risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity,~     and malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and~     home-based intervention to improve physical activity and nutrition behaviors in adolescents~     ages 11-15 over a period of 2 years.~      This study is unique in that it will be one of the first to evaluate a combined physical~     activity and nutrition intervention for youth that revolves around the primary health care~     setting. The PACE+ intervention is particularly innovative in that three components -~     computer, provider counseling, and an extended home-based intervention - are unified through~     a common theoretical framework.~   "
106919|NCT01657409|"~     Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or~     without urge urinary incontinence (UUI) that may affect the patients' quality of life.~     Current medical treatments are usually unsuccessful in completely eradicating urgency~     sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of~     neurotransmitters from sensory nerve endings and effectively modulates the inflammatory~     process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results~     were achieved with intravesical BoNT-A injection, which increased bladder capacity and~     decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity~     (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of~     BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity~     increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also~     improved significantly. However, post void residual (PVR) volume increased significantly and~     some patients required clean intermittent catheterization (CIC) to evacuate the PVR.~     Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore,~     adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help~     to maintain success rates.~   "
106920|NCT01657396|"~     The primary objective of this study is to evaluate the effectiveness and feasibility of the~     implementation of revised standards of care for oral hygiene (SAGE Q-care q2 Oral Cleansing~     and Suctioning System with and without chlorhexidine gluconate) relative to the current~     routine standard of care in mechanically ventilated patients admitted to the adult Intensive~     Care Units in Alberta Health Services Calgary Zone. This pilot study will evaluate the~     feasibility of performing a larger definitive study. The primary assessment of effectiveness~     for the definitive study will be the proportion of patients who develop~     ventilator-associated pneumonia.~   "
106921|NCT01657383|"~     The collection of data regarding patient outcomes after surgical intervention creates~     imperative knowledge to include surgeon performance, cost analysis, base for surgical~     research and publication, which in turn assist surgeons to improve the standard of care~     utilizing evidence-based practice.~   "
106922|NCT01657370|"~     The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the~     treatment of acute migraine, including the influence of demographic and other variables on~     MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations~     and efficacy of the drug.~   "
106923|NCT01657357|"~     Follow up study of patients, who despite periacetabular osteotomy, need a total hip~     arthroplasty, to see outcome.~   "
106924|NCT01657344|"~     The objectives of this study are to: develop an emergency care visit registry for pediatric~     patients for Quality Improvement purposes and to support future research; to use the~     emergency care visit registry to collect stakeholder-prioritized emergency care performance~     improvement measures for important pediatric medical and trauma conditions at the level of~     the ED and individual clinical; and report emergency care performance improvement measures~     to individual ED clinicians and sites, and measure subsequent changes in quality~     performance. The hypothesis is that by providing this type of information to individual~     clinicians will result in improved performance and decreased variability (variation) of care~     for an individual clinician, between different clinicians, and eventually between hospital~     sites.~   "
106925|NCT01657331|"~     This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab~     vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or~     Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial~     treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at~     two subsites in Canada.~   "
106926|NCT01657318|"~     In this study, the investigators hypothesize that the use of olivamine-containing products~     in the management of patients with compromised nonhealing lower extremity ulcers is feasible~     in the Philippine setting. It will result in complete ulcer healing or wound closure after~     16 weeks.~   "
106927|NCT01657305|"~     The main purpose of this phase III clinical trial is to show safety and efficacy of~     Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.~   "
106928|NCT01657292|"~     The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10~     in the acceleration of wound healing of grade 2a burn wounds.~   "
106929|NCT01657279|"~     Background: Several risk score models are now available to assist clinicians estimate~     outcomes after an acute ischemic stroke. Limited information is available on the predictive~     value of these scores compared to real outcomes and clinical judgment.~      Objectives: To compare clinician judgment with the use of a validated stroke risk score~     (iScore) and patients' outcomes.~   "
106930|NCT01657266|"~     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution~     PRO-155 in patients post phacoemulsification.~   "
106931|NCT01657253|"~     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution~     PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with~     ophthalmic solution Systane®~   "
106932|NCT01657240|"~     The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution~     PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic~     conjunctivitis.~   "
106933|NCT01657227|"~     Objective:~        -  To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by~          influencing disease self-management through lifestyle modification and by helping~          primary care professionals to improve health care provided to patients.~        -  To assess the effectiveness and cost-effectiveness of two complex interventions~          (education and behavioural modification, independently and conjointly, for primary~          health care teams (PHCT) and patients and their relatives) to improve the health~          results in people with T2DM.~      Methodology:~      Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands.~     Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures:~     HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm.~     Intervention: G1: Interventions on the patients: Educational and habit modification group~     program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge~     about the disease and their abilities; b) Computer-based clinical decision support system;~     c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group.~     Patients receive only the usual care.~   "
106934|NCT01657214|"~     Primary Objective:~      In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.~      In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in~     patients with measurable and MET gene amplification (including gastric cancer patients).~      Secondary Objectives:~      To characterize and confirm the global safety profile of SAR125844 including cumulative~     toxicities.~      To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic~     effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore~     the relationship of MET gene amplification status with antitumor effects.~      To evaluate other pharmacodynamic biomarkers.~   "
106935|NCT01657201|"~     The purpose of this study is to evaluate the pharmacokinetic properties and safety of~     SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).~   "
106936|NCT01657188|"~     Prospective, follow-up registry of heart failure patients with or without sleep-disordered~     breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with~     Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac~     performance and event-free survival.~   "
133286|NCT01310400|"~     A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine~     Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.~   "
106941|NCT01657123|"~     Exposure to stress alters the activity of the adrenomedullary, adrenocortical and~     sympathetic nervous system, depending on the type and intensity of the stressor. Physical~     exercise represents a stress condition influencing many systems in the body. Given a~     workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the~     hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogenous cortisol secretion~     results in important metabolic and cardiovascular effects to maintain cellular and organ~     homeostasis. Patients with Addison's disease are not able to meet the increased demand of~     adrenal steroids in case of physical exercise, which may result in an impaired exercise~     capacity and a prolonged post-exercise recovery. We hypothesize that a hydrocortisone stress~     dose increases exercise capacity and improves post-exercise recovery in patients with~     Addison's disease.~   "
106942|NCT01657110|"~     Mild to moderate facial acne is an extremely common disease of teenagers and young adults.~     This pilot study will investigate whether treatment with a gel containing tea tree oil~     reduces numbers of acne lesions and improves acne in twenty otherwise healthy consenting~     participants. The hypothesis is that treatment with tea tree oil gel will result in a~     significant improvement in acne after 12 weeks of treatment.~   "
106943|NCT01657097|"~     Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study~     was performed to gain information on this inflammation, including effect of intranasal~     corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.~      The study was randomised, placebo-controlled double-blind in patients, monoallergic to~     grasspollen, presenting symptoms of rhinitis and asthma during season.~      Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of~     treatment intranasal allergen challenge was performed. Measurements were performed during~     the full study period.~      The study was performed out of pollen season.~   "
106944|NCT01657084|"~     By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is~     induced, without causing hypoxia in the patient.~      Based on the scientific literature on the subject, the study hypothesis is that the fall in~     body pH will be able to stop and/or prevent epileptic brain activity.~   "
106945|NCT01657071|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by~     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in~     healthy male volunteers.~   "
106946|NCT01657058|"~     Soluble, viscous fibre has been established as an effective dietary component for lowering~     postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been~     related to its ability to increase the viscosity of the intra-luminal contents of the small~     intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic~     response, dependent on the viscosity development in the gut, would require that soluble~     fibre be extractable from the food matrix. This, in part, may be dependent on the food~     matrix that the soluble fibre is incorporated in. While properties of soluble fibre and~     their physiological effects have been studied extensively, limited data exists on the most~     effective mode of administration of fibre to optimize benefits. Furthermore, there are no~     studies to date that have evaluated how different modes of highly viscous soluble fibre~     would affect the subsequent meal. Hence, we propose a research study to determine whether~     the form of administration, taking into consideration the carbohydrate availability of a~     viscous fibre blend supplement, has a significant impact on postprandial and second meal~     glycemic response and subjective satiety in healthy individuals.~   "
106947|NCT01657045|"~     This study will investigate the safety and efficacy of using JVS-100 to accelerate wound~     healing and reduce scar formation in subjects receiving surgical incisions (sternotomies)~     during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16~     - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be~     followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be~     enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of~     needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be~     delivered along the edge of the sternal wound using a needle-free injection device that has~     FDA-clearance for subcutaneous injections.~   "
106948|NCT01657032|"~     Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized,~     double blind, placebo-control trial was performed to assess the effectiveness of both LGG~     and smectite in management of children with acute gastroenteritis (AGE).~   "
106949|NCT01657019|"~     To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50~     or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults~   "
106950|NCT01657006|"~     The investigators intend to prospectively enroll consecutive patients, without known~     ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary~     care center.~      Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a~     one-hour period of Holter ECG digital recording. Application of ECG electrodes will be~     performed by medical technicians following standard recommendations, utilizing approved~     Holter device & stickers. The Holter ECG data will be used for the offline heart rate~     variability (HRV) analysis by the HeartTrends device.~      Immediately following data acquisition, all patients will undergo an exercise MPI according~     to accepted clinical practice guidelines.~      Following the MPI, there will be no interference with patient management, which will be~     conducted by the patients' treating physicians according to current guidelines, unaware of~     HRV results.~      Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results,~     by HeartTrends device.~      The results of the HRV tests will not be available to treating physicians and will not be~     used to guide patient management. Patients will be followed for 6 months for the occurrence~     of coronary interventions and MACE, defined as: death, myocardial infarction, unstable~     angina, or any coronary revascularization.~   "
106987|NCT01656525|"~     Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and~     preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild~     to moderate AD.~   "
106990|NCT01656486|"~     Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon~     pathologic examination of the normal portion of the pancreatic gland that was in the~     radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for~     utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease~     pancreatic secretions, thus decreasing autodigestion.~   "
106951|NCT01656993|"~     Background: Blood clots cause poor outcomes, including death, in babies with heart defects~     that require a surgical connection (shunt) to provide blood flow to their lungs. Aspirin~     (ASA) blocks the part of the blood that helps clots form (platelets). Aspirin is used in~     babies with shunts to prevent blood clots. The dose of aspirin given to babies is based on~     adult research. Because babies are different from adults, the investigators do not know if~     the dose is enough to block platelets, or if it is too much and may cause bleeding. The~     investigators can test the platelets using a blood test called Thromboelastography with~     Platelet Mapping (TEG-PM). This test needs a small amount of blood so it can be used in~     babies.~      Hypothesis and Specific Aims: The investigators suspect the aspirin doses typically given~     babies are not enough to block platelets and prevent blood clots in their shunts. The~     investigators want to determine the percentage of babies whose platelets are not blocked~     enough (< 70% inhibition), by using TEG-PM. The investigators also want to determine how~     often bleeding or clots occur in babies receiving aspirin.~   "
106952|NCT01656980|"~     The purpose of the study is to determine the safety and efficacy of intracranially implanted~     Carmustine in the treatment of patients with primary malignant glioma.~   "
106953|NCT01656967|"~     The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu®~     Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of~     insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu~     Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in~     patients undergoing general anesthesia for elective surgery.~   "
106954|NCT01656954|"~     The purpose of this study is to understand and document measurements in heart stroke volume~     (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or~     amount of blood pumped by your heart per minute) during a passive leg raise maneuver~     (elevation of the legs), and to determine if these measurements can predict changes in the~     same as a result of fluid or blood product administration.~   "
106955|NCT01656941|"~     The purpose of this study is to examine the role of genetic variation in the oxidative~     stress response on critical perioperative and short-term outcomes after neonatal heart~     surgery. The goals will be to determine 1) if the oxidative stress pathway is an important~     one for therapeutic intervention in neonates with severe congenital heart defects and 2) if~     variants in the oxidative response pathway can be used to identify patients at increased~     risk for adverse outcomes.~   "
106956|NCT01656928|"~     This study assesses the impact of a nutritional intervention aimed at reducing childhood~     overweight in German preschoolers.~   "
106957|NCT01656915|"~     Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an~     inflammatory response and examine differences in the inflammatory response between healthy~     and compromised subjects.~      The purpose of the current study is to examine the inflammatory response in a younger~     population (35-45 yrs old) to see whether in this population also differences in the ex vivo~     LPS induced cytokine response exists between healthy and compromised subjects, as is seen in~     elderly subjects. Overweight subjects showing a state of disturbed blood glucose control~     will be included as subjects with compromised health and compared to healthy lean subjects~     with the same age (shifting from healthy towards unhealthy, not diseased).~      Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory~     cytokine response in a healthy population that is different from a response of the~     compromised population. The investigators will include subjects aged 35-45 years that differ~     in health characteristics, especially blood HbA1c, fat% and waist circumference.~   "
106958|NCT01656902|"~     For the cartilage cell product NOVOCART® 3D plus, which is used in the study described here,~     the company TETEC AG obtained an expanded production authorization from the medication~     monitoring authorities in compliance with Section 13, Para. 1 of the Medicinal Products Act~     in 2003. This entitles TETEC AG to produce the pharmaceutical product and already distribute~     it. More than 6000 patients were already successfully treated with NOVOCART® 3D in Europe~     since 2003. In order to obtain a general market authorization for NOVOCART® 3D plus, this~     control group study is conducted, in which the superiority of the safety and effectiveness~     of carrier-bound Autologous Chondrocyte Transplantation with NOVOCART® 3D plus compared to~     the standard of care microfracture surgery needs to be proven. This study further aims at~     developing and validating known and new biologic markers for the quality and clinical~     efficacy of the product as requested in the context of identity, purity and potency~     characteristics of the medicinal/investigational product.~      The patients will receive one of the therapeutic procedures in the study. The treatment~     procedure which will be used will be decided by a previously specified random process. This~     type of study meets the high quality requirements of the statutorily specified safety and~     quality regulations which are also referred to as Good Clinical Practice (GCP). The~     probability of the patient being allocated to one of the two treatments is 2:1; that is, an~     approx. 67% probability of therapy with NOVOCART® 3D plus and an approx. 33% probability of~     therapy with microfracture. Neither the patient, nor the investigator will be able to~     influence the treatment assignment.~      Patients will be screened for eligibility at the Screening Visit. Each patient will remain~     in the study for 36 months post-implant for the effectiveness assessments, and then an~     additional two years to complete the planned post-market phase. Each patient will be in the~     study for up to five years.~      Cells and tissues collected from this study will be used in other in vitro-controlled~     experiments aimed at developing and validating known and novel biologic markers to quantify~     cell quality in the context of identity, purity and potency. Prognostic values of these~     biologic markers will be examined by correlating them with clinical data collected in this~     study.~   "
106959|NCT01656889|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      This research is being done to compare the efficacy of HP802-247 plus compression therapy~     against Vehicle plus compression therapy in achieving complete wound closure over the~     12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.~   "
106960|NCT01656876|"~     The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror~     therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people~     with stroke.~   "
106961|NCT01656863|"~     The purpose of this study is to determine parental attitudes towards oral rehydration~     therapy for children with mild to moderate dehydration.~   "
106962|NCT01656850|"~     The purpose of the study is to examine whether almond consumption for 3 month will help~     Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of~     cardiovascular disease.~   "
107017|NCT01656122|"~     The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in~     HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.~   "
107018|NCT01656109|"~     There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in~     HIV-infected Asian children. Therefore, the investigators aim to evaluate the~     pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.~   "
106963|NCT01656837|"~     Parental substance abuse is a leading determinant of child maltreatment and, consequently,~     is often linked with negative clinical outcomes for children, exorbitant financial costs for~     the child welfare system, and serious social costs for the investigators nation. Yet, in~     spite of the seriousness of child maltreatment in the context of parental substance abuse~     and that there are well-established effective treatments for adult substance abuse,~     substance-abusing parents in the child welfare system are less likely to be offered services~     and receive services. Well-integrated treatments for the dual problem of substance abuse and~     child maltreatment are virtually nonexistent in the research literature. This study is a~     randomized controlled trial comparing Comprehensive Community Treatment to Multisystemic~     Therapy-Building Stronger Families (MST-BSF), an integrated model of two evidence-based~     treatments for parental substance abuse and child maltreatment that has shown promise in a~     4-year pilot.~      Statement of Study Hypothesis:~      Compared to Comprehensive Community Treatment, parents receiving MST-BSF will show greater~     reductions in parental substance abuse and psychological distress, greater increases in~     employment, drug-free activities, social support, and positive parenting, and fewer~     incidents of reabuse of a child. Children whose families receive MST-BSF will experience~     fewer child out-of-home placements and greater reductions in internalizing symptoms such as~     anxiety.~   "
106964|NCT01656824|"~     Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil~     reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice~     and transform their bone marrow cells into non-Bv8 producing cells. than we will implant~     primary human tumor tissue (taken from surgical specimens after informed consent)in those~     mice and follow-up on the mice.~   "
106965|NCT01656811|"~     Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II,~     parallel-group study of up to four weeks in duration. The study consisted of a screening~     visit followed by a one-week single blind placebo period. At next visit, each subject was~     randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180~     mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4~     times a day for 21 days.~   "
106966|NCT01656798|"~     The main objective of this study is to estimate the effect of food on sildenafil~     pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of~     sildenafil citrate.~   "
106967|NCT01656785|"~     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study~     to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of stroke~     patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg~     BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semi-quantitative~     method will be used to assess the PET/CT images. Changes of 18F-FDG PET/CT, enhanced brain~     MRI or CT, and any adverse events will be collected from the patients.~   "
106968|NCT01656772|"~     This study will evaluate the use of a robotic device that is remotely controlled to maneuver~     a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation~     procedures.~   "
106969|NCT01656759|"~     Applying a fibrin spray, after knee device implantation, will help in reducing patient blood~     loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased~     blood loss there should be a reduced need for blood transfusions.~   "
106970|NCT01656746|"~     This study is being done to evaluate single incision laparoscopic surgery (SILS) for~     colorectal diseases, compared to multi-port laparoscopic surgery. This study is also~     intended to standardize the SILS technique for colorectal diseases~   "
106971|NCT01656733|"~     This is a clinical trial to determine if the nicotine inhaler in combination with counseling~     will help pregnant women quit smoking, and whether it is safe when compared to placebo (an~     inactive inhaler).~   "
106972|NCT01656720|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in~     the treatment of faecal incontinence, compared against placebo~   "
106973|NCT01656707|"~     The purpose of this study is to examine an Adaptive Treatment approach in order to improve~     outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.~   "
106974|NCT01656694|"~     This study will be conducted to assess the survivorship of a particular prosthesis used in~     unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed~     with isolated medial or lateral compartmental arthritis and have failed conservative~     treatment. The patients received a unicompartmental knee replacement using the Sigma® HP~     Partial Knee System.~   "
106975|NCT01656681|"~     The purpose of this 2-stage intervention study is to investigate the effect of a novel~     nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and~     weight loss maintenance in obese participants.~   "
106976|NCT01656668|"~     The purpose of this study is to investigate the effect of BC1036 (theobromine) on~     cough-related quality of life and cough severity following 2 weeks' treatment.~   "
106977|NCT01656655|"~     PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family~     relationships. This study will examine some of the effects on parenting, from the~     perspective of the parent with PTSD.~   "
106978|NCT01656642|"~     This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of~     atezolizumab (anti-PD-L1 antibody) in combination with vemurafenib or vemurafenib plus~     cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled~     participants may continue treatment until they are no longer experiencing clinical benefit~     as assessed by the investigator and in alignment with the protocol.~   "
106988|NCT01656512|"~     Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts~     for one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug~     registry data, children prescribed more than three courses of systemic glucocorticoids~     yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once~     glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year~     after treatment (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators~     will study the role of bisphosphonates in the prevention of secondary osteoporosis in~     children & adolescents treated for ALL in the Children's Cancer Hospital -Egypt.~   "
106989|NCT01656499|"~     The purpose of this study is to evaluate the effect of AXOS on parameters of colon~     metabolism and gut health~   "
106979|NCT01656629|"~     Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility~     fractures are devastating consequences of osteoporosis. The most common treatment approach~     in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN).~     Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available.~     Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing~     fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a~     growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone.~     Different osteoporosis medicines may have differing effects on this process. The effects of~     ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized,~     clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone~     mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data~     collected will include bone biopsies for histomorphometry and micro computed tomography~     (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating~     bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in~     humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone~     progenitor cells to bone resorption sites, and 3) increase bone progenitor number in~     peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will~     have the opposite effect. Understanding the differences in bone progenitor cell activity and~     recruitment during osteoporosis therapy will provide a mechanistic rationale for effective~     use of PTH and anti-resorptive drugs in osteoporosis treatment.~   "
106980|NCT01656616|"~     The costs to a rural emergency medical services (EMS) system of a change from a traditional~     cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The~     purpose of this study is to use current EMS data to calculate the costs to a rural EMS~     system associated with the adoption of a hydroxocobalamin protocol for the treatment of~     suspected cyanide exposure.~   "
106981|NCT01656603|"~     This study will evaluate the safety of infusion of the investigational cord blood units by~     carefully documenting all infusion-related problems.~   "
106982|NCT01656590|"~     The research protocol will be submitted for approval to the institutional review board of~     Columbia University Medical Center. An attempt will be made to recruit at least 6 juvenile~     patients between the ages of 8 and 17, preferably who are still ambulatory.~      Subjects meeting all eligibility criteria will undergo a full history and physical~     examination, including details of age of onset of symptoms, distribution and severity of~     muscle weakness, muscle function, pulmonary function, and nutritional status. Subjects will~     undergo an electrocardiogram (ECG), spirometry, muscule strength evaluation, exercise~     capacity, functional muscle tests, laboratory tests, and muscle biopsy. Quality of life will~     be assessed via SF 36 questionnaire. Functional ability and level of handicap will be~     assessed by Rotterdam handicap scale. Written informed consent will be obtained from all~     subjects.~      All patients, who will have received enzyme replacement therapy (ERT) for at least 2 years,~     will be evaluated prior to institution of high protein nutrition and exercise therapy plus~     nocturnal enteral feeding (HPET + NEF)(baseline), then again at 3 months, 6 months and 12~     months into treatment. The following parameters will be evaluated-~        -  Skeletal Muscle Function~        -  Biochemical parameters from collected blood sample Muscle Biopsy will be obtained at~          baseline and at 12 months. Biopsy specimens, obtained from thigh muscle at baseline and~          a repeat biopsy of the corresponding area of the other leg at 12 months, will be~          analyzed as follows:.~        -  Histology and electron microscopy~        -  Autophagic and lysosomal function evaluation~        -  Body composition Body mass index (BMI), body composition, lean body mass, and fat mass~          will be measured at each visit by bioelectric impedance analysis using BI-101Q RJL~          Systems, software 3.1b~   "
106983|NCT01656577|"~     Background:~      - Stress can cause people to give in to temptations to eat less healthily. People who are on~     weight loss diets often have problems sticking to their diets when they are stressed. Some~     tests have shown that the drug pexacerfont can help reduce stress-related seeking of~     high-calorie foods. However, it has not been tested on reducing food craving. Researchers~     want to test pexacerfont on people who are on diets to see if it can reduce stress-related~     food cravings.~      Objectives:~      - To see if pexacerfont can help reduce stress-induced food cravings.~      Eligibility:~      - Individuals between 21 and 65 years of age who are on a diet to control their weight.~      Design:~        -  Participants will be screened with a physical exam and medical history. This study~          requires seven visits over about 35 days.~        -  Participants will take either pexacerfont or placebo pills during the study. They will~          have three pills every morning. They will record video of themselves taking the pills~          every day.~        -  Every evening, participants will fill out a questionnaire. It will ask questions about~          feelings and behaviors related to eating and food craving.~        -  Participants will have regular study visits while taking the pills. The visits will~          involve questions about stressful situations and food cravings. One visit will involve~          a mildly stressful math test, followed by tasting of different foods. This test will~          look at whether pexacerfont can affect food preferences. Participants will provide~          blood and saliva samples as directed at these study visits.~        -  Participants will have follow-up phone calls 1, 3, and 6 months after the end of the~          study.~   "
106984|NCT01656564|"~     Background:~      - Long-term survival with the human immunodeficiency virus (HIV) is not well understood.~     Adults who were infected with HIV as children have lived with the virus for many years.~     However, the effect of HIV on this group of people has not been studied in depth.~     Researchers are interested in studying how HIV infection and the medicines used to treat it~     affect people who were infected early in life. They want to find out if there are any~     problems with how HIV-infected children grow and develop as adults, especially if they have~     developed heart problems. As part of this study, people with HIV will be compared with~     healthy volunteers.~      Objectives:~      - To study the effect of HIV infection and treatment on people who acquired HIV infection in~     early life.~      Eligibility:~        -  Individuals at least 18 years of age who were infected with HIV before age 10.~        -  Healthy volunteers at least 18 years of age who have no history of heart disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have~          regular study visits about once a year for up to 10 years to collect health~          information.~        -  Blood and urine samples will be collected to look at kidney and liver function.~        -  X-ray scans will be used to look at bone density and the amount of fat and muscle in~          the body.~        -  Heart function tests and imaging studies, including ultrasound and echocardiograms,~          will be used to look more closely at the heart.~        -  Treatment will not be provided as part of this study.~   "
106985|NCT01656551|"~     The purposes of this study are to test whether the addition of cisplatin to single agent~     chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with~     non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs~     survival as compared to gemcitabine in elderly patients with non squamous NSCLC.~   "
106991|NCT01656473|"~     The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an~     integrated treatment approach for youth with concurrent disorders. The combined intervention~     will include individual sessions of Motivational Interviewing, followed by inclusion in a~     Dialectical Behaviour Therapy skills-based group.~      The following main hypotheses will be examined:~        1. Youth with CD who receive an MI intervention will show increased motivation and~          readiness to change from pre to post MI intervention.~        2. Youth with CD who participate in a DBT intervention (orientation session followed by~          12-week DBT skills training group)will show reductions in substance use and~          improvements in mental health, coping and affect regulation between pre to post~          treatment. The investigators expect that these treatment gains will be maintained at~          three-month follow-up.~   "
106992|NCT01656460|"~     The purpose of this study is to evaluate the efficacy and toxicity stereotactic body~     radiation (SBRT) as consolidation following standard chemoradiation for patients with stage~     III non-small cell lung cancer.~   "
106993|NCT01656447|"~     The overall objective of the Scleroderma Registry is to support and promote the basic~     science and clinical research of this complex rheumatic disease at the Hospital for Special~     Surgery (HSS). The registry facilitates our understanding of the clinical features,~     pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment~     for this currently untreatable condition.~   "
106994|NCT01656434|"~     The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate~     + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active~     American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2~     were assessed and compared to those of women taking a norethisterone acetate + ethinyl~     estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.~      Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of~     Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio~     was adapted accordingly for participants randomized after the sample size increase.~   "
106995|NCT01656421|"~     Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of~     cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular~     disease is a major cause of death in such patients and it may be related to excess~     stiffening of the walls of major arteries, such as the aorta, and it has been suggested to~     represent premature aging. However, there is little known of the development of these~     problems, which were previously considered to be due to smoking and which is now known not~     to be the only factor. The investigators will study a large group of patients with mild to~     very severe airflow obstruction based on the NICE 2010 classification of severity and a~     matched comparator group free of COPD. This study involves three assessments of the~     development of the complications of COPD over a five year period. The key measure will be~     the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart~     disease. Changes in wall stiffness will be related to the severity of lung disease; other~     known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol~     and to cardiovascular events including heart attacks and death; and to the presence of other~     complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures~     will be analysed in the context of changes in bodywide inflammation and metabolic function~     and the changes in the rate of ageing. This increased knowledge of interacting factors in~     the complications of COPD is likely to lead to studies of treatments to avoid their~     development.~   "
106996|NCT01656408|"~     This randomized, double-blind, placebo-controlled, multiple-rising-dose study will evaluate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8150 in healthy young~     men, in male participants with mild to moderate hypertension, in elderly male and female~     participants with mild to moderate hypertension, and in male and female participants with~     resistant hypertension. A primary study hypothesis is that there is at least one dose that~     does not increase heart rate (HR) to a clinically meaningful extent in male participants~     with mild to moderate hypertension and in elderly participants with mild to moderate~     hypertension on either Day 1 or the last Day of multiple dosing (Daylast), as measured by~     Time-weighted Average Across 24 hours (TWA0-24hrs). The hypothesis is met if mean increase~     (MK-8150 - placebo) in TWA0-24hrs HR in the identified groups is ≤15 beats per minute on Day~     1 and Daylast.~   "
106997|NCT01656395|"~     The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and~     safety of MK-1029, alone or in combination with montelukast, compared to placebo and to~     montelukast alone, in the treatment of persistent asthma in adults.~   "
106998|NCT01656382|"~     The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7~     days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of~     patients with disseminated cryptococcosis and HIV.~   "
106999|NCT01656369|"~     The aim of the study is to compare Delorme operation alone or with post anal repair and~     levatorplasty for treating complete rectal prolapse.consecutive patients who were treated~     for complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The~     patients were randomized into two groups: Group I: consisted of patients were subjected to~     delorme operation only. Group II: consisted of patients were subjected to delorme operation~     with post anal repair and levatorplasty.~   "
107000|NCT01656356|"~     The purpose of this study is to evaluate safety and reactogenicity of live attenuated~     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,~     in Thailand to previously healthy Thais.~   "
107001|NCT01656343|"~     -  To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD)~          in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept~          at the time of transplantation~        -  To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone~          transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the~          time of transplantation~        -  To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant~          recipients treated with belatacept to the rates in adult, EBV seropositive, kidney~          alone transplant recipients treated with CNI-based regimens at the time of~          transplantation~   "
107002|NCT01656330|"~     The purpose of this study is to assess the use of 2 different Prothrombin Complex~     Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of~     rivaroxaban in healthy adult volunteers.~   "
107003|NCT01656317|"~     The study's main objective will be to assess which effect early initiated rehabilitation has~     on the frequency of complications and the level of physical and cognitive functioning after~     aneurysmal subarachnoid hemorrhage (SAH).~      To this end the following aspects will be investigated:~      The frequency of complications (with special emphasis on pulmonary~     complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of~     drains and lines)~        -  Length of stay in hospitals and socio-economic impact~        -  Physical and cognitive function in the early and chronic phase after SAH~        -  Health-related quality of life and participation in society in the chronic phase~   "
107004|NCT01656304|"~     This pilot phase II trial studies how well giving bevacizumab works in treating patients~     with relapsed prostate cancer that did not respond to hormone therapy. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     tumor-killing substances to them. Bevacizumab may also stop the growth of prostate cancer by~     blocking blood flow to the tumor~   "
107005|NCT01656278|"~     The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided~     treatment strategy based on a predefined treatment algorithm can prevent progression of~     erosive joint damage, increase remission rate and improve functional level in the short and~     long term in patients with rheumatoid arthritis (RA).~   "
107006|NCT01656265|"~     The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in~     hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the~     recommended dose of ARQ 197 in advanced HCC patients.~   "
107007|NCT01656252|"~     Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag~     while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help~     increase the number of platelets during chemotherapy and may help prevent the risk of~     bleeding.~      Phase I will study the side effects, best dose and platelet effects of eltrombopag when~     given with consolidation chemotherapy. After the maximum safe and tolerated dose and~     schedule is found in Phase I, the study will proceed to Phase II. Phase II will confirm the~     dose and schedule of eltrombopag identified in Phase I that can increase platelet counts in~     patients receiving consolidation therapy.~   "
107008|NCT01656239|"~     The purpose of this study is to determine the dose level(s) of fedovapagon which result in a~     decrease in the mean nocturnal void frequency.~   "
107009|NCT01656226|"~     The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona~     AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis~     patients after 6 months of treatment.~   "
107010|NCT01656213|"~     TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal~     disease patients DESIGN Eandomised Conrol Study AIMS~        1. Undertake detailed characterisation of stroke (including recently developed imaging~          techniques at Imperial) of stroke in renal disease patients including clinical, imaging~          and epidemiological data~        2. To Investigate if passive intervention using hand grip device during dialysis sessions~          will improve functional outcome from stroke in end stage renal disease patients.~      OUTCOME MEASURES~        1. Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores.~        2. Secondary outcome: 3 months change in NIHS & Bartel scores~      POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at~     Hammersmith's Hospital's renal Unit. .~      ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be~     retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with~     acute (<7 days) stroke affecting arm.~      DURATION 2 years~   "
107011|NCT01656200|"~     Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more~     than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used~     since 2006. JE vaccines give protection by generating a neutralizing antibody response, but~     both naturally exposed persons and patients with JE also have T cell responses. Whether JE~     vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that~     T cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this~     study is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to~     investigate differences in T cell responses between natural exposure, vaccination and~     disease.~   "
107012|NCT01656187|"~     The purpose of the study is to determine if an investigational drug called memantine,used~     here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms.~     We will also examine changes in the brain by taking images or pictures using an MRI/MRS.~   "
107013|NCT01656174|"~     The objective of this study is to test individual donor samples (IDSs) with the~     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue~     Assay in the clinical setting.~   "
107014|NCT01656161|"~     The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5~     mg 6-month formulation administered by the subcutaneous (under the skin) route in:~        -  achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days~          after investigational medicinal product (IMP) injection], and~        -  in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month~          12 (Day 337) in participants with advanced prostate cancer.~   "
107015|NCT01656148|"~     Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two~     pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking~     speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot~     Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this~     has not been investigated in patients responding to the drug measured by the abovementioned~     test.~      The question is if this will be the case and also if another walking test, termed the Six~     Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.~      Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not~     less sensitive to the effect of Fampridine-SR than T25FW.~   "
107016|NCT01656135|"~     To investigate the progression of the immunological response in living-donor kidney~     transplant recipients treated with a standard immunosuppressive regimen. Clinical,~     immunological, and health-economic data collected during this Reference Group Trial will be~     used to corroborate historical renal transplantation statistics and generate reference~     ranges for future clinical studies that will test immunoregulatory cell therapy as an~     adjunct immunosuppressive treatment in renal transplantation.~   "
107020|NCT01656083|"~     Research indicated that the relapse rate of smokers who attempted to give up smoking without~     drug and other assistance is up to 90-95% while the successful cessation rate may be~     improved a lot with assistance to quit smoking. There are two kinds of measures to help~     smokers quit smoking: one is psychological and behavioral intervention, including the advice~     to quit smoking provided by doctors during daily health service and smoking cessation~     hotline; another is provision of drug therapy. 2008 smoking cessation Guidance plays~     emphasis on the effectiveness of smoking cessation of Varenicline and also on role of~     doctor's behavioral intervention in smoking cessation as Class A of evidence-based rating;~     among which, doctor's consultation (three minutes) at minimum intensity is effective;~     high-intensity consultation (more than ten minutes) is more effective than that of~     low-intensity consultation; and return visit for more than four times will distinctively~     improve the smoking abstinence rate. It is unrealistic to apply high-intensity and~     high-frequency smoking cessation intervention on all smokers due to the busy clinical work~     of domestic doctors. Systematic and standardized short message intervention system may be~     helpful to improve abstinence rate. Meanwhile, it can reduce human labor and physical~     resources, and improve the frequency of follow-up visit to smokers. It is observed during~     the process of offering smoking cessation services to smokers that, it would be one of the~     very effective measures to provide timely and useful information to smokers at several~     critical phases of smoking cessation course (such as three weeks before smoking cessation,~     prevention of relapse, etc.). Doctors, however, are usually passive during this period and~     unable to provide assistance to smokers with initiative. As people are more and more aware~     of the harmfulness of smoking and more and more smokers are increasingly willing to give up~     smoking, it is necessary to create an instant active information distribution system, which~     provides immediate active smoking cessation short message support through universally used~     mobile phone short message service to achieve the purpose of helping them quit smoking.~   "
107021|NCT01656070|"~     Along with its effects on bone metabolism, vitamin D is an important modulator of the immune~     system. Experimental studies have shown that the active metabolite of vitamin D [1,25(OH)2D]~     is able to skew the T cell compartment into a more anti-inflammatory state, with inhibition~     of Th1 and Th17 cells and promotion of Th2 and T regulatory subsets.~      In the context of HIV infection, in which Th1 subpopulations are devoted to inhibit viral~     replication, any alteration of the Th1/Th2 balance would be of concern.~      The aim of this Randomized Controlled Trial is to test wether oral supplementation with~     cholecalciferol could be able: 1) to improve vitamin D status and, 2) to play an~     immunomodulatory role, in vertically HIV-infected children and young adults with~     hypovitaminosis D.~   "
107022|NCT01656057|"~     The last couple of years it has been shown that bile acids not only acts as simple~     emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an~     influence on fat digestion and lipid metabolism, but also modulates the energy expenditure~     in (brown) adipose tissue and muscle tissue. This action is due to stimulation of the~     receptor TGR5 by bile acids. Recently scientists have discovered that this receptor in~     rodents is also expressed on the surface of intestinal L-cells (which normally secrets~     Glucagon-Like Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of~     this receptor has shown a GLP-1 secretion from the intestinal cells which is interesting~     since GLP-1 has a central role in maintaining normal glucose tolerance and thus blood sugar.~     Given the above, bile acids has an important impact on intestinal GLP-1 secretion. Whether~     these scientific findings can be proven in human beings is uncertain.~      The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK)~     in healthy subjects will result in a significant GLP-1 response. We also hypothesize that~     adding orally Metformin or a sequestrant (a bile acid binder) will further enhance this~     GLP-1 response.~   "
107023|NCT01656044|"~     The purpose of this research study is to evaluate if a negative-pressure dressing placed~     over a surgical incision can reduce the risk of developing a surgical site infection~     compared to a commonly-used sterile gauze incision dressing. In this study, the~     negative-pressure dressing will be compared to a standard post-surgical sterile gauze~     dressing. In this study patients will either receive a negative-pressure dressing or a~     standard sterile gauze dressing~   "
107024|NCT01656031|"~     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them~     from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to~     see how well they work in treating patients with refractory or relapsed acute myeloid~     leukemia or acute lymphoblastic leukemia.~   "
107025|NCT01656018|"~     The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what~     the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics~     (what the medication does to the body) of TMC278 long acting (slowly effective after initial~     dosage and maintaining its effects over a long period of time) when administered as an~     intramuscular (ie, in to the muscle) injection in adult participants who are seronegative~     for human immunodeficiency virus type 1 (HIV-1).~   "
107026|NCT01656005|"~     Beta blockers are a type of medication mainly used for heart disease. They are commonly used~     to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer~     from heart disease and so already benefit from this treatment for this reason. In addition~     to this, new research suggests that there may be further benefit of using beta blockers for~     COPD, even without also having heart disease.~      The reason why beta blockers are not widely used in COPD at present is because of their~     potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are~     the opposite type of medication to 'beta-agonists' such as salbutamol which you may be~     taking for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used~     in COPD where the benefits (for example heart disease) outweigh any risks.~      Current COPD treatment includes inhaled steroids and long acting beta agonists, often given~     in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and~     airway narrowing, leading to improvement in symptoms. Another drug commonly used is~     Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with~     widening the airways.~      In this study, we wish to find out if two different types of beta blocker cause different~     effects on the airways in COPD patients. One type of beta blocker is more 'selective' in~     acting mainly on the heart, with the other type having more general or 'non-selective'~     effects on both the heart and lungs. By doing this we will also be able to look at how the~     beta blockers work alongside the 'usual' inhaler treatment described above.~   "
107027|NCT01655992|"~     Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.~   "
107045|NCT01655758|"~     This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of~     drugs acting either on aqueous humor production (inflow drugs) or on aqueous humor outflow~     (outflow drugs) in human eyes affected by ocular hypertension and virgin to treatment. The~     enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and~     n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that~     outflow drugs may offer a better and more stable control of IOP through the 24 hours.~   "
107028|NCT01655979|"~     The human being has shown that he can live and work in the space environment, but due to the~     lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations~     in the acid-base balance (mainly on account of nutritional factors), the exposure to~     microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning~     of the cardiovascular system and metabolic changes. Countermeasures to prevent all the~     deconditioning of the physiological systems are not yet fully effective and require further~     investigation.~      A commonly utilized model of simulating the physiological effects of microgravity on the~     human organism on ground is the 6° head-down-tilt bed rest. In the present study the model~     has been used to study potential countermeasures to spaceflight-associated deconditioning.~      One of the most constrictive changes appearing during space flight as well as during bed~     rest, are disuse-induced muscle losses. These are associated with a decrease in muscle~     protein synthesis, rather then an increase in muscle protein breakdown. Besides an effective~     training countermeasure, nutritional countermeasures gain respect in this context:~     supplementing conventional diets with whey protein or essential amino acids has been shown~     to increase muscle protein synthesis. Due to these anabolic properties whey protein seems~     promising to counteract disuse-induced muscle wasting.~      Drawbacks of a high protein intake are calciuric effects, ascribed to the proton-release~     when metabolizing sulfur-containing amino acids. The so called 'low grade metabolic~     acidosis' has also shown to activate osteoclastic bone resorption and muscle protein~     degradation. Therefore, to maximize the anabolic potential of a whey protein~     supplementation, the acidogenic properties need to be compensated. As previous works~     suggest, a shift of acid base balance into the acid direction and the resulting changes in~     bone and protein turnover may be hindered by supplementing alkaline mineral salts.~      In this regard, a mid-term bed rest study was performed in order to investigate the effect~     of a combined whey protein (0.6 g/kg body weight/day) and potassium bicarbonate (90~     mmol/day) supplementation as a potential countermeasure to multiple physiological and~     metabolic alterations on the human body resulting from real and simulated microgravity.~   "
107029|NCT01655966|"~     Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4.~     Conventional standard of care treatment has modest response with only 50% sustained~     virologic response. Recent reports have suggested an augmented response with the addition of~     vitamin D. This is a prospective randomized trial to assess the effectiveness of adding~     vitamin D to standard of care for chronic hepatitis C genotype 4.~   "
107030|NCT01655953|"~     The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride,~     salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced~     physiological systems. Due to increased urinary calcium excretion and bone resorption a high~     NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline~     diet is known to have a beneficial influence on bone metabolism. Therefore the investigators~     hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.~      8 healthy male volunteers took part in a stationary study carried out in the metabolic ward~     of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days.~     Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days~     of stationary recovery. During the intervention period the volunteers diet was NaCl-rich~     (7.7 mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium~     bicarbonate (KHCO3) in a randomized cross-over design. The other campaign served as control.~      Bone metabolism was studied by bone formation markers in the fasting morning blood and~     24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in~     the fasted and the postprandial state as well as urinary markers. Protein turnover was~     studied with stable isotopes. Further physiological systems like energy metabolism and the~     cardiovascular system are also under investigation.~   "
107031|NCT01655940|"~     In this prospective study to try to standardize the care for patients, the investigators are~     planning to compare two cerebral oximeters currently in use at NCH in terms of their~     accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen~     saturation. Also, the investigators will compare these devices in terms of their response to~     changes in hemodynamics that occur during cardiac surgery.~   "
107032|NCT01655927|"~     The purpose of this study is to determine whether Tranexamic Acid is effective or not in the~     reduction of intraoperative bleeding loss in brain tumors resections.~   "
107033|NCT01655914|"~     This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I.V~     flumazenil administration.~      Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a~     final dosage of 1.1 mg per 100 µl and 2.2 mg (200 µl) in a sublingual spray administration.~      Currently, Flumazenil is given as an IV drug with a repetitive administration of doses of~     0.2 mg up to 3 mg per hour. As the bioavailability of Flumazenil is expected to be lower~     than the IV administration, 1.1 mg and 2.2 mg will be tested in sublingual delivery. The~     suggested doses in this study are very safe according to the following data: first,~     sublingual and buccal administration of Flumazenil have been detailed previously with~     similar and higher doses with no side effects, secondly, IV dose may reach 3 mg and thirdly,~     oral administration has been reported as up to 600 mg/dose.~      The purpose of this study is to determine the single dose PK profile of SL CRLS035. This~     study is designed to collect short-term safety data and to monitor the PK profile of~     CRLS035.~      Primary Objective The primary objective is to determine the single dose safety and PK~     profile of SL CRLS035 using the marketed IV flumazenil formulation as the comparator.~      Secondary Objectives The secondary objectives are to (1) characterize the concentration time~     course of two dose levels of SL CRLS035 to support dose selection for Phase 2 and 3 studies~     and to evaluate the safety and tolerability of flumazenil formulations; (2)To evaluate the~     effect of high fat diet and water consumption on the PK profile.~   "
107046|NCT01655745|"~     This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma~     of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned.~     This pilot study is designed to provide preliminary information on the accuracy of [18F]~     Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of~     muscle-invasive bladder cancer.~   "
107047|NCT01655732|"~     S. mutans counts have been found to be high in women with high level of untreated caries. In~     Pakistan 95% of all carious lesions are untreated that is an alarming situation. A majority~     of mother's have high level of caries and pose an increase risk of vertically transmitting~     it to their children. Therefore, the aim of this study is to determine the effect of A~     Traumatic Restorative Treatment(ART) in reducing S. mutans count in pregnant women and~     indirectly reduce the vertical transmission of S. mutans to their children so that ART as a~     preventive program may be provided and promoted in periurban areas where there is a lack of~     accessibility to oral health care.~   "
107048|NCT01655719|"~     Through this trial the investigators hope to learn if a drug, Actos (pioglitazone), is~     useful in treating a certain kind of metastatic thyroid cancer. Actos is approved by the FDA~     to treat diabetes. It has not been approved by the FDA to treat cancer, so its use in this~     study is considered experimental.~   "
133728|NCT01304654|"~     Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care~     Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.~   "
107034|NCT01655901|"~     STATEMENT OF THE PROBLEM: Video games have enormous mass appeal, are omnipresent in the~     daily schedule of most children and youth and have been linked to the obesity epidemic. The~     investigators research group recently reported that sedentary video game playing increases~     food intake in adolescents. Interestingly, the overconsumption of food associated with~     seated video game play was observed without increased sensations of hunger and appetite, as~     previously observed with television viewing. Active video games offer an appealing~     opportunity for increasing energy expenditure and promoting healthy body weight among~     children and youth who might otherwise be spending time in sedentary screen-based~     activities. However, significant increases in energy expenditure as a result of active video~     game play might be of little importance to energy balance if one compensates by increasing~     energy intake and/or decreasing physical activity. Studies to date have failed to measure~     energy intake so it is currently unknown the effects of active video games on daily energy~     balance.~      OBJECTIVE: The main aim of this study is to examine the acute effects of playing active~     video games on energy intake and expenditure.~      HYPOTHESIS: The investigators hypothesize that the increase in energy expenditure promoted~     by active video games will be offset by compensatory adjustments in food intake and~     spontaneous physical activity subsequent to the intervention.~      RESEARCH PLAN: With the use of a randomized crossover design, 30 normal-weight and 30 obese~     adolescents between 13 and 17 years of age will complete three 1-hour experimental~     conditions, namely (1) resting in a sitting position (control condition), (2) playing Xbox~     360 (sedentary video game condition) and (3) playing Kinect (active video game condition),~     followed by an ad libitum lunch. The primary outcomes will be acute (24-h) and short-term~     (3-day) energy intake and expenditure. Food intake will be measured using an ad libitum test~     meal immediately following the intervention, a food menu for the remainder of the day and a~     dietary record for the subsequent 3-day period. Energy expenditure will be measured using~     indirect calorimetry during the intervention and an Actical accelerometer for the subsequent~     3-day period. Secondary outcomes will include appetite sensations (visual analogue scales),~     stress markers (heart rate variability, blood pressure, and mental workload), and levels of~     appetite-related hormones and substrates (glucose, insulin, cortisol, leptin, and ghrelin).~      RELEVANCE: The present study is innovative and likely to result in a number of new and~     important findings that can inform future recommendations. If the investigators confirm our~     hypothesis, the clinical implication will be to rethink the strategy of promoting active~     video games as an intervention tool for the prevention of overweight and obesity in youth.~   "
107035|NCT01655888|"~     RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity~     of tremelimumab in malignant mesothelioma (MM) patients.~      PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive~     schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive~     investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks~     until confirmed disease progression.~   "
107036|NCT01655875|"~     This study is for patients 2-21 years old who have acute leukemia that has not responded~     well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study~     of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard~     pre-transplant conditioning regimen (total body irradiation, etoposide and~     cyclophosphamide). The conditioning regimen is the treatment that is given just before the~     transplant. This treatment kills leukemia cells as well as healthy bone marrow and immune~     cells. Researchers want to learn more about how AMD3100 affects acute leukemia cells. Blood~     and bone marrow samples from study participants will be collected to find out if AMD3100 is~     making patients' cells more sensitive to the conditioning regimen and to find out how it~     does this.~      The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that~     three doses do not significantly increase the side effects of transplant conditioning, the~     investigators will give a second group of six patients five daily doses.~   "
107037|NCT01655862|"~     This is an observational study to assess health-related quality of life in patients with~     cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.~   "
107038|NCT01655849|"~     This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for~     safety and efficacy for a period of 6 weeks.~   "
107039|NCT01655836|"~     The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes~     called internal radiation therapy. High dose rate brachytherapy is a procedure that involves~     temporarily placing radioactive material inside the patient's body for about 10-20 minutes.~     Then, the remainder of the radiation treatment will be given over a 3 week period using~     stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves~     the delivery of very high individual doses of radiation to tumors with high precision. This~     allows the doctor to deliver the same amount of radiation in a much shorter time. The~     purpose of this study is to determine the safety of brachytherapy when combined with~     hypofractionated SBRT.~   "
107040|NCT01655823|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of~     many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin,~     bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in~     greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing~     is often either decreased or discontinued potentially affecting tumor responsiveness,~     prognosis, and survival.~      There is an unmet medical need for treatment of cancer patients with chemotherapy induced~     neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of~     multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic~     pain caused by chemotherapy.~   "
107041|NCT01655810|"~     African-Americans have higher rates of cardiovascular disease morbidity and mortality, as~     well as vitamin D deficiency. Multiple observational studies have demonstrated an increased~     risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation~     between cardiovascular disease and vitamin D levels; however, there is a lack of~     interventional trials exploring this connection. The objective of this proposal is to~     address the hypothesis that treatment of vitamin D deficiency in African Americans with type~     2 diabetes will improve subclinical markers of cardiovascular disease.~   "
107042|NCT01655797|"~     The aim of this study was to investigate the clinical effectiveness of protocol-driven~     cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel~     (primary care nurses and social workers) in general medical practice with unselected~     patients, in line with a stepped care approach. The study design was a randomised controlled~     parallel group design, with allocation to CBT and waiting list control group (WL). Following~     an active treatment-control period, the control group were re-assigned to CBT. The study~     hypothesis was that the CBT group would experience less symptoms of insomnia after treatment~     compared with the WL group. Primary outcome measure was a brief self-report screening form,~     Insomnia severity index.~   "
107043|NCT01655784|"~     This trial is being conducted in order to compare angiographic outcomes in patients~     receiving 0.014-0.0155 platinum framing and filling coils (larger diameter coils) versus~     those treated solely with coils less than 0.014 (with a standard diameter).~      Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients~     receiving 0.014-0.0155 platinum coils during embolization compared to those receiving~     smaller-diameter coils.~   "
107049|NCT01655706|"~     This study is a pilot to assess feasibility of the protocol in patients and controls across~     six participating sites. The goal is to identify biological markers (biomarkers)that can be~     measured at baseline or early in treatment to predict treatment outcome in individual~     patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical~     (using interview and self-report measures), molecular (from blood samples) and~     neurobiological (using neuroimaging and EEG).~   "
107050|NCT01655693|"~     The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is~     effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma~     (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis~     and with good liver functions are eligible. Only those who can not benefit from treatment~     for which efficacy is demonstrated are eligible.~      These patients are usually proposed either best standard of care (BSC) or participation to~     clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2~     or DT at 30 mg/m2 or the BSC.~   "
107051|NCT01655680|"~     This is a safety and efficacy study evaluating a experimental treatment for cognitive~     deficits in adults with schizophrenia.~   "
107052|NCT01655667|"~     To characterise and understand the current UK COPD population including demographics, active~     comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis~   "
107053|NCT01655654|"~     The primary purpose of this study is to identify the percentage of health care workers~     working in an acute care hospital who have high blood pressure, to determine the awareness~     of their blood pressure status, and to see how well it is managed. Study participants will~     come from the following three distinctly different types of departments: telemetry~     (clinical), non-telemetry (clinical), and non-direct patient care staff. All study~     participants are offered educational information surrounding high blood pressure and review~     the recommendation for their primary care engagement. Study participants with high blood~     pressure will be asked to continue in the study for up to 6 months. It is intended that each~     study participant who continues will take their blood pressure three times a day and record~     the results in a study provided diary. Each study participant should also make some of the~     suggested changes that promote a healthier lifestyle including exercising, improving their~     diet, and seeing their primary care provider. It is the thought that these changes will~     reduce the study participant's blood pressure. The secondary purpose is to determine the~     effect shift work has on these hospital employees and the potential positive effects of the~     three interventions.~   "
107054|NCT01655641|"~     Primary objective of the study is to compare requirement of blood transfusion and mortality~     in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it.~      Secondary objective is to; assess the re-bleeding events; need for surgical intervention;~     length of stay in Intensive care unit in between the two groups.~   "
107055|NCT01655628|"~     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in Southern China~     and South Asia. After radiotherapy, some patients with nasopharyngeal carcinoma still had~     distant metastasis. In recent years, some chemotherapeutic agents, such as gemcitabine,~     cisplatin, were used to treat patients with advanced nasopharyngeal carcinoma, including~     those with local recurrence and distant metastases, with a certain short-term effect.~     However, chemotherapy alone is still not ideal for effectively improving the prognosis of~     patients with advanced nasopharyngeal carcinoma. Therefore, it is necessary to develop~     more-effective adjuvant therapies.~      CIK cells (cytokine induced killer cells, CIK) are a population of heterogeneous cells~     generated by the in vitro amplification of mononuclear cells in peripheral blood. The cells~     are co-induced with multiple cytokines; the lymphocytes with co-expression of CD3+CD56+ have~     the strongest anti-tumor effect. Because of their non-MHC restricted tumor killing activity,~     CIK cells have a powerful anti-tumor effect both in vitro and in vivo, which spans a broad~     anti-tumor spectrum.~      In this study, the patients with post-radiotherapy distant metastasis of NPC will be treated~     with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen~     chemotherapy(GC). The purpose of this study is to observe and evaluate the toxic side~     effects and the short- and long-term efficacy of CIK used in combination with GC~     chemotherapy to treat NPC in patients with distant metastasis after radiotherapy. Patients~     and Methods: 40 patients with distant metastasis after radiotherapy will accept 4 cycles~     chemotherapy of Gemcitabine plus cisplatin regimen and then are randomized divided into 2~     groups. The 20 patients in GC+CIK group will be treated with maintaining therapy of adoptive~     autologous CIK cell transfusion sequentially; the other 20 patients will be followed-up only~     without CIK cells treatment. The safety of chemotherapy and CIK cells transfusion and the~     tumor regression status will be observed. The early response and long-term efficacy of two~     groups patients who accept GC chemotherapy or GC +CIK bio-therapy will be investigated.~   "
107056|NCT01655615|"~     The Preventure Program is the first and only school-based alcohol and drug prevention~     program that has been shown to prevent onset and growth in alcohol and substance misuse in~     British and Canadian youth. Unlike universal programs that tend to promote generic coping~     skills and balance normative attitudes around substance use, this selected~     personality-targeted approach is based on a psychosocial model and validated by Dr Patricia~     Conrod and targets four personality-specific motivational pathways to substance misuse:~     Hopelessness, Anxiety Sensitivity, Impulsivity and Sensation Seeking, each associated with~     different motives for substance use, drug use profiles and patterns of non-addictive~     psychopathology.~      As a primary goal of the Coventure project, the investigators propose a long-term trial of~     this intervention strategy to examine how this evidence-based intervention can reduce onset~     of substance use disorders in young people and related secondary mental health, academic and~     cognitive outcomes.~      As a secondary goal, the investigators propose to use sensitive neuropsychological measures~     to examine how this evidence-based intervention can positively impact on cognitive~     development over the course of adolescence, to tease apart some of the mechanisms involved~     in the causal pathway from early onset substance use to poor cognitive development and~     long-term addiction outcomes.~   "
107057|NCT01655602|"~     This study aim to compare cosmetic results between 3 trichophytic closure techniques for~     donor site (the trimming of upper, lower and both edge of linear incision) in hair~     transplantation.~   "
107058|NCT01655589|"~     The main purpose of this study is to investigate the association between VEGF gene~     polymorphism and the response to intravitreal drugs in neovascular age-related macular~     degeneration. This is a retrospective review of patients treated between 2008 and 2012 at~     the Institute of Vision, in Belo Horizonte, Brazil.~   "
107059|NCT01655576|"~     The purpose of this study is to determine if placental drainage shortens third period of~     labor and reduces postpartum blood lost.~   "
107071|NCT01655420|"~     This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related~     quality of life (QoL) of 300 civilian participants prior to and three months following~     state-of-the-art laser in situ keratomileusis (LASIK).~   "
107167|NCT01654120|"~     The purpose of this study is to determine the effect of adding liraglutide to high dose~     insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated~     Type 2 diabetes with insulin requirements of > 100 units of insulin per day.~   "
107060|NCT01655563|"~     Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid~     organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus~     through genetics will help in early attainment and maintenance of the correct dosage level~     in the early post-transplant period. This pilot dose-finding trial will help to determine a~     dosing strategy guided by genotypes and age for solid organ transplant recipients that will~     be further validated through a multi-centre trial as an immediate next step. The study~     hypothesizes that dosage levels determined through age and genotype will be attained faster~     and more accurately than the standard dosing procedures in the 14-days after the transplant.~     Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster~     recovery (tested through the kidneys' ability to clear creatine from the blood) and result~     in lower frequencies of adverse effects and rejection of the transplant.~   "
107061|NCT01655550|"~     The investigators seek to demonstrate the non-superiority of oral contrast versus no oral~     contrast in intravenously enhanced CT in the outpatient setting. The investigators want to~     decrease preparation time for the patient and decrease delay in obtaining the study which~     will ultimately lead to faster results and an increased level of patient convenience.~      The investigators hypothesis: Oral contrast does not significantly affect the diagnostic~     confidence of interpreting radiologists in intravenously enhanced abdominal CT scans.~   "
107062|NCT01655537|"~     Fibromyalgia is a common rheumatologic disorder. Many patients complain of cognitive~     dysfunction as part of their symptoms.~      The investigators aim to assess this cognitive dysfunction through extensive neuro-cognitive~     testing.~   "
107063|NCT01655524|"~     The investigators developed a modified regadenoson nuclear stress test of the heart that~     incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The~     modified (ASSUAGE) protocol has been associated with fewer side effects and was better~     tolerated by patients.~      This study will investigate whether the modified regadenoson stress protocol (ASSUAGE)~     produces blood flow pattern to the heart similar to that of a standard regadenoson stress~     protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a~     wide scale instead of the current standard protocol.~   "
107064|NCT01655511|"~     This study in healthy male and female volunteers will investigate the safety and~     tolerability of three increasing oral doses of tafamidis~   "
107065|NCT01655498|"~     The objective of this study is to obtain preliminary efficacy and safety data on the use of~     the LivSure System (now called the Eclipse™ System) in women with fecal incontinence.~   "
107066|NCT01655485|"~     The purpose of the research is to test the effectiveness of the social story intervention~     delivered using the iPAD application Going to Imaging on the anxiety, challenging child~     behaviors, child injuries and completion rates among children with ASD undergoing medical~     imaging procedures. A secondary purpose is to test the effect of this intervention on the~     anxiety levels of the parents of ASD children undergoing medical imaging procedures.~      Hypotheses:~      H1: Children with ASD who are exposed to a story book Here the investigators go to medical~     imaging (x-ray) to prepare for medical imaging compared with children with ASD exposed to~     treatment as usual (TAU) will have:~        1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline~          compared to up to two hours later).~        2. Exhibit fewer challenging behaviors as measured by a behavior observation scale~          (developed for the study (up to 2 hours after baseline)~        3. Higher procedure completion rate.~        4. Shorter time to complete a procedure.~        5. Less child injuries.~           H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of~          children with ASD who are exposed to a story book Here the investigators go to medical~          imaging (x-ray) to prepare for medical imaging will have:~        6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).~   "
107067|NCT01655472|"~     Schizophrenia is a common disorder with a lifetime prevalence of about 1%.Genetic studies~     strongly suggest a genetic component to the inheritance of schizophrenia. Structural~     neuroimaging studies have provided consistent evidence for brain abnormalities in~     schizophrenia. The timing of brain abnormalities in schizophrenia has not been determined~     yet.~      The investigators hypothesize that brain structural changes can be detected in neonatal~     life. The investigators hypothesize that offspring of schizophrenic patients will have~     higher rates of brain structural changes in the neonatal period. The investigators propose~     to study early development of fetuses in offspring of patients with schizophrenia. The study~     is a multi-center prospective trial.~   "
107068|NCT01655459|"~     Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA~     fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA~     malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of~     esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then~     reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA~     position, but the rotated degree of LMA was not considered in that grading. We hypothesized~     that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be~     detected on ultrasound. This study was designed to assess the predictability of the rotated~     LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.~      Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to~     this study. Ultrasound was performed on supraglottic and vocal cords area before and after~     LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was~     evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was~     showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to~     one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre-~     and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of~     rotation were measured.~   "
107069|NCT01655446|"~     The purpose of this proposal is 1) to compare the relative effects of the robotic~     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare~     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and~     the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will~     potentially influence the functional outcomes after interventions.~   "
107070|NCT01655433|"~     This study will look at the safety of treating patients with heart attack with mild~     hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that~     the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely~     and with adequate performance.~   "
107072|NCT01655407|"~     The purpose of this research study is to test how well the investigational treatment,~     Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.~      The areas of the body that are treated with ESS-W will be compared to similar areas treated~     with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG)~     will be performed by taking healthy skin from one area of the body and placing it on the~     burned area.~   "
107073|NCT01655394|"~     IVIg exert a variety of different immunomodulatory effects and several mechanism of action~     have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction~     in patients with immune-mediated neuropathies will be explored.~   "
107074|NCT01655381|"~     This open-label, single arm, multicenter long-term extension study will evaluate the safety~     and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe~     rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible~     participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104~     weeks.~   "
107075|NCT01655368|"~     This multi-center, 2-arm interventional study within different mental health care settings~     (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation)~     evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment~     using a psychotherapeutic module embedded in a psychoeducational group therapy.~   "
107076|NCT01655355|"~     Between the years 1999-2011 70 patients went through a revision of the hip joint(revision~     after not successful Total or Partial Hip Replacement). During the revision the Acetabular~     implant was found to be stable and it was decided not to replace it. The polyethylene insert~     was replaced and was fixated using a cement. Our purpose is to evaluate the physical~     condition of these patients.~   "
107077|NCT01655342|"~     Clinical and radiographic assessment of Biodentine® as a pulp dressing material for~     pulpotomy treatment in human primary molars.~   "
107078|NCT01655329|"~     This is a study to determine whether or not a new type of software is, or is not, of~     benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists~     to detect tubes, lines and wires that may be placed within a patients chest. These types of~     devices are commonly used for very sick patients in intensive care units and are also used~     following surgery and in the treatment of cancer. This study will test radiologist's~     detection of the tips of these devices comparing the results with standard chest radiographs~     and the the modified chest radiographs. The primary interest is in the time used to~     interpret the radiograph. We will determine if there is any change in accuracy of detection.~   "
107079|NCT01655316|"~     PSVT is a common rhythm disorder in emergency department which can be recurrent in some~     cases.~      Intravenous Adenosine is the drug of choice in PSVT control in acute settings but is a very~     short acting agent.~      Providing a complementary medication to decrease the rate of recurrence of PSVT after its~     initial control will be promising.~      This study evaluates the role of the oral Verapamil in recurrence control of PSVT in~     emergency situations.~   "
107080|NCT01655303|"~     Rate control in atrial fibrillation is a usual battle in emergency departments. Oral~     medications have a natural superiority to intravenous ones because they are easy-to-use and~     decrease the workload in busy emergency departments.~      This study wants to find an effective oral medication for rate control in rapid ventricular~     response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are~     compared in patients with a stable hemodynamic status.~   "
107081|NCT01655290|"~     This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate~     dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed~     enhancement cardiac Magnetic Resonance Imaging~   "
107082|NCT01655277|"~     Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength,~     thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve~     block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC)~     of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes~     included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment~     of fall risk with the Berg Balance Scale (BBS) at 30 minutes.~   "
107083|NCT01655264|"~     The overall goal of the study is to evaluate the clinical effectiveness of a home-based~     tele-motion-rehabilitation (TMR) program in improving functional status of people who had~     stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the~     hospital of the TMR will be greater in comparison to self-training exercise carried out at~     home in improving outcomes of Range of Motion and functional performance of the weak upper~     extremity.~      Twenty-four subjects who had a stroke, aged between 18 and 80 years, and living at home will~     participate. Subjects will be 2-72 months post stroke, and no longer receiving~     rehabilitation as in or out patient. They will have moderate impairment of the affected~     upper extremity determined by range of motion (ROM). Subjects will be evaluated for motor~     and cognitive abilities for a total of 5-6 hours by a skilled therapist who will be blind to~     group's assignment of the subjects. The evaluations will be repeated 3 times, once before~     the intervention commences, once immediately following the intervention and once four weeks~     after the intervention.~      Subjects will be randomized into the two groups (TMR versus self-training treatment) with~     matching for level of impairment of the upper extremity by a person who is not part of the~     study. Each subject will receive twelve 45-60 min sessions over 4 weeks while seated. The~     control group will receive self-training exercises that are based on conventional therapy~     using principles of motor control and will include training of upper extremity movements in~     order to achieve better use of the affected arm in ADL. The experimental group will receive~     TMR treatment of comparable duration and intensity to those in the conventional treatment~     group with remote online monitoring by the therapist. Treatment feedback will be given in~     the form of Knowledge of results (game scores) and Knowledge of performance (feedback of~     compensatory movements made while using the upper extremity) to enhance motor learning. The~     software will generate a report which will include the duration and type of exercises~     performed by the subject.~      The Gertner TMR system is implemented via Microsoft's Kinect three-dimensional) camera-based~     gesture recognition technology. Using the patient's natural hand and body movements control~     all activity within customized computer games. The system runs off a standard desktop~     computer and is displayed on a large television screen.~   "
107084|NCT01655251|"~     To evaluate the effect of video discharge instructions on return visits to the ER or ED~     within 72 hours of the original visit for children with febrile illnesses.~   "
107085|NCT01655238|"~     The investigators are concerned about anesthetizing obese children in outpatient locations~     in case they need prolonged stay, increased respiratory interventions, or need for~     post-operative narcotics. The investigators will be using a screening guideline to help us~     determine the higher risk child based on BMI and co-morbid conditions. The investigators~     will also be doing a retrospective chart review of 300 patients with BMI 95% and looking at~     various factors during the operative and post-operative period.~   "
107123|NCT01654692|"~     This study is designed to assess the safety and efficacy of a combination of ipilimumab and~     fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.~   "
107086|NCT01655225|"~     The purpose of this study is to find a recommended dose level and schedule of dosing~     LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The~     study will also explore the changes to various markers in blood cells and potentially tumor~     cells. Finally, the study will help document any antitumor activity this drug may have.~      In Part A of this study, participants with advanced/metastatic cancer (including lymphoma)~     will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in~     different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.~   "
107087|NCT01655212|"~     The objective of the trial is to investigate whether early treatment with oral~     valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural~     hearing loss can prevent progression of hearing loss.~   "
107088|NCT01655199|"~     During the previous phases of the project (Phase I and II), two new field tests have been~     designed and validated for an integration in a primary care setting in Chronic Obstructive~     Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min~     paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted,~     particularly by the reduction of dyspnea level following bronchodilatation, Phase II~     highlight that the 3MPST does not allow to detect this decrease of dyspnea after~     bronchodilatation. The use of too high step rates could explain these results through a~     hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial~     is to follow the investigations on the sensitivity of 3MPST to detect the effects of~     pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of~     this work is that the use of lower step rates cadences could allow to detect an improvement~     of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step~     rates.~   "
107089|NCT01655186|"~     This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will~     assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in~     approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes~     Mellitus (T2DM).~   "
107090|NCT01655173|"~     The purpose of this study is to determine if adults with autism spectrum disorder and with~     normal intelligence improve from 36 sessions (1 calendar year) of group treatment with~     Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.~   "
107091|NCT01655160|"~     The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms~     of mirror therapy and its effects on physiological markers.~   "
107092|NCT01655147|"~     The purpose of this study is to assess the effects of repeated daily administration of~     rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone~     following single-dose administration of abiraterone acetate tablets in healthy male~     participants.~   "
107093|NCT01655134|"~     The telemonitoring systems for congestive HF did not yet prove their efficacy despite~     initial encouraging results. Decongestion is one of the main objectives in Congestive HF,~     but an appropriate titration of diuretics is warranted, since long-term use of diuretics was~     consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et~     al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic~     effects, as assessed by an estimated plasma volume depletion, in addition to~     potassium-sparing properties, independently from renal function variations. These three~     parameters were independently associated with patient outcomes and may therefore be~     potential monitoring/and therapeutic targets in patients with congestive HF.~      Main objective :~      To assess the variations of estimated plasma volume, serum potassium and estimated~     glomerular filtration rate after an hospitalization for decompensated HF, by using a~     home-based finger capillary punction for 5 consecutive days per week during the two months~     postdischarge, using an approved dedicated device (ABOTT iSTAT).~      Secondary objectives :~        1. to assess the correlations between plasma volume, serum potassium and estimated~          glomerular filtration rate variations (as measured by Istat, and by a weekly venous~          punction) and body weight, home blood pressure measurement, dyspnea self assessment~          variations.~        2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis~   "
107094|NCT01655121|"~     Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune~     response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and~     liver failure.~      There are few studies on dietary management in hepatitis and most of theme have focused on~     micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of~     other diseases associated, but few recommendations have been made regarding a complete~     dietary approach. Fiber has been proven to increase the excretion of nitrogen products and~     consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to~     decrease endogenous catabolism in cirrhotics patients.~      The implementation of a high protein high fiber nutrition plan and improves nutritional~     status of patients with autoimmune cirrhosis.~   "
107095|NCT01655108|"~     This study aims to investigate the effectiveness and safety of mesotherapy for the treatment~     of female pattern alopecia.~        -  Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss~          will undergo mesotherapy sessions weekly for ten weeks.~        -  One group will receive 0.5%/2ml minoxidil application and a control group will receive~          application of placebo (saline 0.9%).~        -  Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before~          and 08 weeks after treatment as a method objective evaluation of the response~   "
107124|NCT01654679|"~     The purpose of this study is to dermine whether local-water filtered infrared-A (wIRA)~     irradiation can reduce postoperative wound infection. wIRA irradiation is applied 20min~     directly preoperatively, before patients underwent abdominal surgery. The wIRA is a harmless~     light source, that has been described before. We test the impact and clinical outcome of~     patients undergoing a one-time preoperative wIRA irradiation on postoperative wound healing.~   "
107125|NCT01654666|"~     Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory~     effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the~     investigators will use clinical outcome, serum biochemical markers and brain magnetic~     resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory~     effects on patients undergoing carotid artery stenting.~   "
133758|NCT01304264|"~     To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is~     statistically superior to twice a day (bid) timolol with regard to increasing ocular blood~     flow~   "
107096|NCT01655095|"~     Colon capsule endoscopy is a technology that has been developed as a noninvasive method of~     examining the large bowel. The biggest limitation to its use has been finding a bowel~     preparation that will both clean the colon adequately for good visualization of the mucosa~     and also help propel the capsule through the colon. Most studies have been conducted in~     Europe using bowel preparation medications that are not approved for use in North America.~      The purpose of this study is to compare a combination of polyethylene glycol (PEG) and~     prucalopride to Picosalax and prucalopride to determine which regime will give a better~     colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are~     used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved~     for use in Canada which improves intestinal motility and should help with colon capsule~     transit.~      Patients who are being referred for colonoscopy will be enrolled in the study and randomized~     to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation~     with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard~     bowel preparation, patients randomized to the Picosalax group will take dulcolax three~     nights before the test and then again two nights before the test. The evening before the~     test patients will take either PEG 2L or one sachet of Picosalax. The following morning they~     will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They~     will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours~     they will return to the endoscopy unit where they will undergo a colonoscopy, which is the~     standard of care for examination of the colon.~      The images from the colon capsule will be reviewed and the quality of bowel preparation will~     be graded using a previously validated scale. It is hypothesized that the Picosalax and~     prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as~     there will be less turbid fluid in the colon and allow for a better view of the mucosa.~     Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be~     compared to polyps and abnormalities detected at the time of colonoscopy.~   "
107097|NCT01655082|"~     The purpose of this study is to evaluate the safety profile of a repeated application of a~     new transdermal patch compared to a reference product during 3 weeks, in a large population.~   "
107098|NCT01655069|"~     This is a 40-week study to investigate how safe and effective solifenacin solution is in~     treating children/adolescents with symptoms of overactive bladder (OAB) who completed study~     905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day~     patient diary prior to every visit, starting at Visit 9. The patient will attend the study~     clinic on 7 separate occasions. The first visit of this study (905-CL-077) will be combined~     with the last visit of the 4-month study 905-CL-076. At each visit, the patient will be~     required to undertake a number of assessments or examinations to determine whether it is~     safe for him/her to take part or to continue to take part in the study. During the first 3~     visits the dosage of the study drug will be adjusted if needed in order to optimize the most~     effective and safe dose for each patient.~   "
107099|NCT01655056|"~     The study aims to investigate the effect of YM150 and to compare gender and ethnic~     differences in healthy Caucasian and Japanese male and female subjects.~   "
107100|NCT01655043|"~     Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the~     U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery~     disease that is considered most accurate is coronary angiography however it involves risk~     and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi~     qualitative analysis of the myocardial perfusion images.~      In this proposal the investigators will develop a means to calculate Coronary Flow Reserve~     (CFR) using the MRI. the investigators approach has the potential to reduce mortality from~     myocardial infarction by effecting a change in the patient management paradigm. Absolute~     quantification of myocardial perfusion will detect coronary stenosis and CAD in patients~     with more accuracy than the semi-quantitative or qualitative analysis of perfusion images.~     Measurement of Coronary Flow Reserve is important for the following reasons: decrease of~     coronary flow reserve has been identified as a first effect of CAD; it provides an objective~     measure of treatment efficacy.~      The purpose of this study is to compare images from nuclear stress test and/or coronary~     angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary~     artery disease calculating myocardial blood flow using a novel MRI technique combined to an~     extracellular Gadolinium-based contrast agent and stressor agent~   "
107101|NCT01655030|"~     The purpose of this study is to determine whether creatine monohydrate is effective as an~     adjuvant treatment for bipolar depression.~   "
107102|NCT01655017|"~     Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis~     amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on~     adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non~     invasive tools to measure fibrosis needs to be validated. The investigators primary aim is~     to validate a new device able to measure adipose tissue stiffness.~      Thus the investigators plan to compare the stiffness results obtained with the device to the~     quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to~     a bariatric surgery.~   "
107103|NCT01655004|"~     Aromatase inhibitors have led to significant improvements in clinical outcomes for women~     with postmenopausal hormone receptor-positive advanced breast cancer. However, there is a~     notable absence of phase III comparisons among the three agents and therefore no clear~     indication of the superiority of one AI over the others. Furthermore, there remains a~     distinct lack of predictive biomarkers of AI efficacy and toxicity to inform clinical~     decisions. The metabolic pathways of exemestane have recently been delineated and UGT2B17 is~     the most active hepatic gluconoryltransferase responsible for the glucuronidation of the~     crucial active exemestane metabolite, 17-dihydroxyexemestane. The UGT2B17*2/*2 deletion~     genotype is associated with markedly reduced glucuronidation of 17-dihydroxyexemestane in~     vitro and is found more commonly in Asians than Caucasians (60-70% vs less than 10%). Our~     research group recently demonstrated significant reduction in glucuronidation of vorinostat,~     a UGT2B17 substrate, with a trend towards improved clinical benefit rate and~     progression-free survival in Asian breast cancer patients who were UGT2B17*2 homozygotes~     treated with this compound. In-vivo studies correlating UGT2B17*2 genotype with exemestane~     pharmacokinetics and pharmacodynamics are lacking. We hypothesize that individuals with~     UGT2B17*2/*2 genotype have reduced glucuronidation of 17-dihydroxyexemestane and therefore~     have increased exposure to the active drug, resulting in improved treatment efficacy. We~     propose a study of exemestane in hormone receptor positive post-menopausal advanced breast~     cancer patients with prospective correlation of treatment outcome by UGT2B17 genotype. The~     primary endpoint is the correlation of genotype (UGT2B17*2/*2 vs those with at least one~     wild-type variant) with clinical benefit rate, and secondary endpoints include its~     association with exemestane pharmacokinetics, progression-free survival, overall survival~     and musculoskeletal toxicities.~   "
107104|NCT01654991|"~     This study randomizes St. Louis men to home-based STD screening or clinic-based STD~     screening. Home-based screening will be completed through the mail and clinic-based~     screening in a local clinical setting. We hypothesize that men randomized to home-based~     screening will be more likely to complete screening.~   "
107105|NCT01654965|"~     This phase I trial studies the side effects and best dose of tivantinib and topotecan~     hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and~     topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
107126|NCT01654653|"~     The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown~     that colloid is better as compared to crystalloids. Several previous studies have~     demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery~     shows a promising effect. This study aims to compare hemodynamic effects and fluid balance~     of HSL with 6% Hydroxy Ethyl Starch (HES).~   "
107106|NCT01654939|"~     For HIV-infected patients who have access to treatment, liver diseases are a major cause of~     morbidity and mortality. Hepatitis C is the most frequently encountered liver condition in~     this population. Both diseases allow a higher level of poisonous substances (toxins)~     normally produced by the bacteria present in the gut to enter the bloodstream. This leads to~     a chronic inflammatory state, which results in faster development of liver scars (fibrosis)~     and ultimately, end stage disease (cirrhosis). To prevent this from happening, the use of~     antibiotics has been attempted to reduce the quantity of gut flora in the hopes of lowering~     the amount of toxins produced. These trials have shown promising results, but the~     antibiotics studied had major side effects and were not designed for continuous use.~     Rifaximin is a non absorbable antibiotic with very few side effects. It is already used for~     long periods of time in cirrhotic patients to treat the effects of cirrhosis on the brain~     (encephalopathy). This project will try to determine if rifaximin, by reducing the level of~     toxins produced by the bacteria in the gut, can improve the evolution of liver fibrosis in~     HIV-infected patients with hepatitis C. In this pilot study, ten patients with HIV and HCV~     infection will be followed for one year. In addition, 10 patients with HCV mono infection~     will also be followed. Both populations will be included if they are starting on rifaximin,~     for its currently approved FDA indication (hepatic encephalopathy).~   "
107107|NCT01654926|"~     Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic~     solution, therefore not causing substantial changes in NaCl concentrations, and the use of~     peripheral veins makes it feasible to use in out of hospital medical centers, for non~     compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United~     States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the~     hypothesis of this study is that it is feasible for a professional team to effectively use~     the UF for short courses on non compensated HF patients with low or no response to~     Diuretics, in a dedicated out of hospital HF center.~   "
107108|NCT01654913|"~     This study examines the effect of oxygen supplementation on the non-invasive measurement of~     hemoglobin.~   "
107109|NCT01654900|"~     The purposes of the investigators study is to examine the overall survival and quality of~     life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical~     center between 2008-2011. All alive patients will be phone interviewed using the 36-item~     short form health survey. Results will be compared to similar health survey results~     (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled~     group). The investigators hypothesize that elderly patients achieve improvement in quality~     of life after open heart surgery with acceptable operative morbidity and mortality.~   "
107110|NCT01654887|"~     The primary objective of this study is to determine if lung ultrasound (LUS) can replace~     chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are~     looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that~     LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can~     replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of~     unscheduled healthcare visits after the index Emergency Department (ED) visit between those~     subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the~     rate of antibiotic use between the two groups, (3) a comparison of the admission rates, and~     (4) a comparison of the length of stay in the Emergency Department between the two groups.~   "
107111|NCT01654874|"~     This trial is a single-blind, cross-over design. Up to three patients with confirmed~     metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses~     of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation~     B). Whole-body planar scintigraphic images will be acquired at various time points on the~     day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of~     study drug administration. Blood will be collected for pharmacokinetic measurements~     following study drug administration. Each participant will receive an initial study drug~     administration (preparation A) and a second study drug administration (preparation B)~     approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3~     weeks after the second study drug administration.~   "
107112|NCT01654861|"~     -  The combination of gemcitabine and HDIVC is safe and may favorably change the clinical~          course for an individual patient.~        -  The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in~          preclinical models, where HDIVC creates a pro-oxidative effect that adds to the~          anti-tumor effect of gemcitabine.~        -  The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).~        -  The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg~          infusion may create sustained elevation in Vitamin C plasma levels for increased~          cytotoxic effect.~        -  The addition of HDIVC & oral supplementation of Vitamin C to standard treatment with~          gemcitabine may improve quality of life for patients with comparison to prior to~          treatment start of this protocol.~        -  CA 19-9 and inflammatory markers may show trends for patients in this trial.~   "
107113|NCT01654848|"~     In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT)~     Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological~     findings in thrombocytes and anti-body patterns is going to be investigated.~   "
107127|NCT01654640|"~     The purpose of this study is the evaluation of effect of metformin on obesity and metabolic~     disturbance in patients taking clozapine.~   "
107128|NCT01654627|"~     The purpose of this study is to examine the safety and usefulness of the Regenecure guided~     bone regeneration membrane for stimulating bone growth in patients that don't have enough~     bone for dental implant placement. The study will include 16 patients in each group, 20~     non-smokers and 12 smokers, a total of 32 patients will participate in the study.~   "
107168|NCT01654107|"~     The investigators propose to develop a theory-based smoking cessation intervention (called~     Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling~     sessions and use of nicotine lozenge for 12 weeks. The investigators will test the~     feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and~     prolonged abstinence).~   "
107169|NCT01654094|"~     The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the~     Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in~     burn wounds resulting from thermal burn injuries.~   "
107114|NCT01654835|"~     The investigators thus propose to use an innovative randomized effectiveness trial design to~     test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡±~     clinical condition and decision-support alerts will prompt earlier hemodynamic support and a~     consequently reduce the duration of such conditions. Specifically, the investigators will~     test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration~     of hypotensive episodes. The core of the investigators study will be an existing electronic~     anesthesia record and smart-alarm decision-support system. All patients undergoing surgery~     at Hillcrest will be randomly assigned to routine care or to DSS support. In patients~     assigned to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning~     within three minutes after detection. Clinicians will be free to act on the alert, ignore~     the alert, or to consider the provided information without acting on it. The randomization,~     complete anesthesia record, detailed record of hypotensive events, alerts provided,~     clinician responses, and SAP response, will be captured by the investigators electronic~     record-keeping system. The investigators primary outcome will be the duration of time the~     patient has a systolic blood pressure less than 80 mmHg. Secondary outcome will be duration~     of hospitalization. The investigators will assess the effect of the alert on the primary~     outcome of time to SBP returning to above 80 mmHg using survival analysis, with time to~     event censored (and considered a non-event) at either the end of surgery or end of~     monitoring if patient did not return to above 80 mmHg.~   "
107115|NCT01654822|"~     This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an~     effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV)~     infection.~        -  Primary endpoint: significant drop in viral load AV2-DM versus placebo~        -  Secondary endpoint:the number of patients with adverse events~   "
107116|NCT01654809|"~     The purpose of this study is to observe the adverse reaction ratio and hemagglutination~     inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split~     influenza virus vaccine in different population.~   "
107117|NCT01654796|"~     This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS)~     for treating patients with treatment resistant depression who are taking an antidepressant~     that is not working for them.~   "
107118|NCT01654783|"~     The objectives of this study are to investigate how oral 5-ASA drugs have been used in the~     condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission~     stage), or in the transition from the condition with symptoms such as abdominal pain or~     diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to~     study how many patients will be able to maintain the remission stage during the observation~     period and how many times the patients will experience the active stage (relapse), as well~     as how symptoms will change during the observation period to discover better treatment~     plans.~   "
107119|NCT01654770|"~     Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with~     significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The~     mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a~     meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in~     patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this~     meta-analysis study was that the included studies examined patients with occult OGIB and~     overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present~     a significant lesion that causes a recurrent bleeding which subsequently increases risk of~     morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB,~     patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE~     in a diagnosis tool with an impact on clinical management.4-7 Although previous studies~     showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE~     first in patients with massive overt OGIB is still uncertain. Thus in this study, we~     conducted the prospective study to compare urgent VCE with urgent DBE in patients with~     massive overt OGIB.~   "
107120|NCT01654731|"~     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that eventually leads~     to end-stage liver failure and death unless liver transplantation (LT) is performed.~     Ursodeoxycholic acid (UDCA) administered orally at the daily dose of 13-15 mg/kg is~     currently the only drug approved for the treatment of PBC. UDCA consistently improves~     biochemical liver tests, prolongs survival without LT, and delays histological progression~     as well as the occurrence of portal hypertension. However, a significant proportion (40%) of~     patients treated with UDCA shows an incomplete biochemical response and remains at high risk~     of death or LT. The development of new treatments in combination with UDCA is therefore~     needed. Several candidates exist among which is Bezafibrate. Bezafibrate belongs to the~     fibrates' pharmacological class, which has been developed 4 decades ago for the treatment of~     mixed hyperlipidaemia. Bezafibrate is cheap, widely available and well tolerated. There is~     now a substantial body of circumstantial evidence supporting that fibrates, and Bezafibrate~     in particular, are well tolerated and can improve biochemical liver tests in patients with~     PBC with incomplete response to UDCA. However, despite several positive successful pilot~     studies, there are still no phase 3 randomized placebo-controlled trials of fibrates for the~     treatment of PBC. The purpose of this protocol is therefore to conduct such a trial in a~     selected population of patients with PBC based on an incomplete biochemical response after 6~     months of UDCA therapy.~   "
107121|NCT01654718|"~     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg~     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is~     equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy~     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg~     of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth~     Laboratories, USA in healthy, adult, human, male subjects under fed conditions.~   "
107122|NCT01654705|"~     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg~     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent~     to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy~     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg~     of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth~     Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting~     conditions.condition.~   "
107129|NCT01654614|"~     Primary objective of this study was to evaluate the diagnostic capability of keratoconus~     match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste~     keratoconus (FFK), and their association with a series of Pentacam-derived keratconus (KC)~     indexes. KMI and KMP parameters are KC-specifc indexes that are measured by Ocular Response~     Analyzer (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.~      Study participants were recruited from the Cornea Outpatient service in a consecutive if~     eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients~     diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.~      All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and~     Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were~     performed by the same experienced operator in a consistent way~   "
107130|NCT01654601|"~     To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.~   "
107131|NCT01654588|"~     Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and~     quantify its severity.In older children and adults, BCT is done using spirometry to measure~     the value of 20% fall in FEV1 as an indicator for positive reactivity.~      However, in young children and infants that cannot perform spirometry, other measurements~     are used as indicators for BHR. Traditionally, in these populations, appearance of wheezing~     on auscultation is used as the indicator for BHR. More recently, other measures like 50%~     increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible~     options to determine positive BHR. Nevertheless, as these measurements probably measure~     different parameters they could vary in time of appearance.~      The investigators also noted that in older children who perform spirometry, the order of~     appearance of these different physiologic measures is not constant.~      Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do~     not all appear at the same time and not in the same order of events.~      Some children are noted to have a decrease in FEV1 without wheezing - those children can be~     difficult to diagnose as asthmatics in the primary care setting where asthma is being~     diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who~     do not wheeze are difficult to diagnose and therefore, are not getting the appropriate~     treatment.~      Nevertheless, the data in current literature is very scant or not existing regarding these~     issues. Thus the investigators designed a study to prospectively try to answer the~     questions: do clinically significant differences exist in the concentration of the~     metacholine and / or adenosine at the time time of appearances of these parameters, what~     comes first, and if so, how does it affect the diagnosis and the severity assessment of HRA~     in different age groups?~   "
107132|NCT01654575|"~     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy~     currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX)~     helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid~     arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in~     decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic~     criteria of primary knee OA with knee pain, were included in this study.Patients meeting the~     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral~     MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and~     secondary outcome measures included improvements in physical function scores.There was a~     statistically significant reduction in pain and improvement in function in the MTX group~     compared to the placebo group at 16 weeks.~   "
107133|NCT01654562|"~     Primary objective: To examine the short-term effects of of simvastatin on the vision on~     males with choroideremia, evaluated by full-field scotopic threshold testing. The~     investigators hypothesize that they will see a reversible decrease in the dark-adapted~     vision in participants taking simvastatin.~   "
107134|NCT01654549|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat~     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)~     index, and anthropometric measurements (body mass index and waist circumference)in~     non-diabetic subjects with non-alcoholic fatty liver disease.~   "
107135|NCT01654536|"~     This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate~     the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray~     administered once daily to male and female subjects 12 years and older diagnosed with PAR.~   "
107136|NCT01654523|"~     The goals of the study are to further design, develop, and test an awareness enhancement and~     monitoring device, which will be used in the self-awareness training and general treatment~     of patients with compulsive hair-pulling behaviors, or trichotillomania.~   "
107137|NCT01654510|"~     The goal of the proposed research is to design and develop a culturally appropriate,~     vocationally focused, sustainable, cognitive-behavioral intervention for unemployed,~     economically disadvantaged, urban-dwelling persons whose job attainment efforts have been~     undermined by the presence of social anxiety disorder.~   "
107138|NCT01654497|"~     The purpose of this study is to try to determine the maximum safe dose of dexanabinol that~     can be administered to people with brain cancer. Other purposes of this study are to:~        -  find out what effects (good and bad) dexanabinol has;~        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for~          use in pharmacokinetic (PK) studies;~        -  learn more about how dexanabinol might affect the growth of cancer cells;~        -  look at biomarkers (biochemical features that can be used to measure the progress of~          disease or the effects of a drug).~   "
107139|NCT01654484|"~     The purpose of this study is to investigate the safety and efficacy of up to three~     concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as~     monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost)~     in subjects with primary open-angle glaucoma or ocular hypertension.~   "
107140|NCT01654471|"~     The aim of the study is to validate the Korean version of Walking Impairment Questionnaire~     in patients with peripheral arterial occlusive disease.~   "
107141|NCT01654458|"~     There is a high prevalence of sexual and body image problems among women treated for~     gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly~     personal nature of these problems, women are often reluctant to speak to their doctors about~     these concerns and have few resources for support and information. The research team will~     conduct a prospective randomized controlled trail (RCT) to test the benefits of GyneGals,~     a 12-week online (i.e. Internet-based) support group intervention for women who are sexually~     distressed due to gynecologic cancer and its treatment.~      The primary aim of this study is to determine whether a professionally-facilitated,~     information-rich, online support group is beneficial for women who are sexually distressed~     due to gynecologic cancer and the side effects of treatment.~   "
107416|NCT01650870|"~     The purpose of this study is to determine the efficacy of a split-dose regimen of~     crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as~     assessed by the physician's determination of the cleanliness of the colon using the Boston~     Bowel Prep Scale (BBPS).~   "
107142|NCT01654445|"~     This trial will enroll patients that have been diagnosed with a transient ischemic attack~     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a~     minor stroke faces the possibility of long-term disability and even death, regardless of~     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve~     or worsen over the hours or days immediately following a stroke. The purpose of this~     research trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as~     a treatment for patients who arrive within twelve hours from stroke onset. This study is~     attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a~     safe treatment for stroke patients. Neither the safety nor the effectiveness of this~     treatment has been proven yet.~      This trial will be conducted at several site in Canada.~      Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial,~     coordinated at the University of Calgary, Foothills Medical Centre.~   "
107143|NCT01654432|"~     General anesthesia and morphine based pain medicine analgesia has been the mainstay of~     practice in breast cancer surgery at Women's College Hospital. There is evidence to suggest~     that patients have a better recovery, with less pain and nausea and vomiting when nerve~     blocks or freezing of nerves are given in addition to a general anesthetic. Specifically for~     breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide~     patients with a better quality of recovery after surgery. The aim of this study is to~     examine whether patients who receive the nerve blocks using an ultrasound machine in~     addition to general anesthesia have a better quality of recovery than patients who receive a~     general anesthetic alone. The hypothesis is that patients receiving ultrasound-guided~     paravertebral blocks (PVB) with propofol-based general anesthesia (GA) will have a better~     quality of recovery than patients receiving general anesthesia-opioid-analgesia. Quality of~     recovery will be assessed using a modification of the QoR-27, a validated instrument to~     assess postoperative recovery in an ambulatory surgical population.~   "
107144|NCT01654419|"~     THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND~     MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS~   "
107145|NCT01654406|"~     Fractional CO2 laser can improve the Cesarian scar~   "
107146|NCT01654393|"~     The purpose of the study is to help doctors in emergency departments know whether triage~     nurse initiated radiographs, in accordance to the Ottawa ankle rule, before emergency~     physician assessment will shorten emergency patients' visit. The investigators will examine~     the number of missed fractures between the two groups, the emergency physicians' willingness~     to apply OAR and triage nurses' satisfaction.~   "
107147|NCT01654380|"~     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.~     This study is designed to understand how the body handles the investigational drug, what~     effect this investigational drug has on the body and how much should be given. This study~     will also measure how much of the investigational drug gets into the blood stream and how~     long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in~     healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus~     (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including~     screening. Screening will be performed within 30 days of the start of the study.~   "
107148|NCT01654367|"~     Select patients of primary breast cancer whose hormone receptor is positive and accepted~     postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with~     zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase~     treatment. Assess the disease-free survival; overall survival; combination of security, as~     well as the situation of bone loss.~   "
107149|NCT01654354|"~     Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide~     768.86mg) in abdominal CT~   "
107150|NCT01654341|"~     The MID-Frail STUDY project focuses on the use of interventions designed to improve~     functional status and enhance quality of life (rather than traditional treatments such as~     glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing~     frailty and its progression to adverse outcomes.~   "
107151|NCT01654328|"~     The purpose of this study is to investigate if home-hydration is a non inferior alternative~     for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk~     patients.~   "
107152|NCT01654315|"~     Of the 5.7 million stroke survivors in the United States, up to 80% exhibit significant~     weakness in one arm (called hemiparesis). This devastating impairment undermines~     performance of valued activities and quality of life. Although rehabilitation is commonly~     provided, conventional affected arm rehabilitative strategies have negative evidence, or no~     evidence, supporting their use. Thus, there remains a need for evidence-based rehabilitative~     strategies for arm hemiparesis.~      Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP)~     incorporating the affected arm. However, many of these promising regimens require~     participation in intensive therapies, and most are only efficacious on the least impaired~     patients. Thus, there remains a need for an efficacious, practical RTP technique to address~     moderate affected arm hemiparesis.~      To address the above shortfalls, one of the investigators team members piloted an innovative~     brace integrating electromyography (EMG) and robotics. In his case series, 8 stroke patients~     exhibiting moderate arm impairment successfully participated in RTP, with the brace (called~     the Myomo) detecting and augmenting their movement attempts. Aided by the Myomo,~     participation in the RTP regimen reduced subjects' affected arm impairment and spasticity.~     The next logical step is to test Myomo + RTP efficacy using randomized controlled methods~     and an appropriate sample size.~   "
107153|NCT01654302|"~     Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number~     of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this~     condition. This study examines a different topical approach, utilizing a topical anesthetic~     agent, to evaluate if application of such an agent would provide relief of exercise-induced~     knee pain in people with knee OA.~   "
107165|NCT01654146|"~     The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or~     carboplatin at a lower dose every week) is more effective than standard chemotherapy~     (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian~     cancer. The investigators also want to see if weekly chemotherapy causes more or fewer~     side-effects than standard chemotherapy.~   "
107154|NCT01654289|"~     The primary goal of this project is to determine whether behavioral training in mindfulness~     meditation or moderate intensity sustained exercise will lead to reductions in acute~     respiratory infection (ARI) illness, such as common cold and influenza like illness.~     Specifically, this project aims to:~        1. Determine whether an 8-week training program in mindfulness meditation, as compared to~          the control group, will lead to significant reductions in incidence, duration, and~          severity of ARI illness.~        2. Determine whether an 8-week training program in moderate intensity sustained exercise,~          as compared to the control group, will lead to reductions in incidence, duration, and~          severity of ARI illness.~        3. Assess whether any observed reductions in ARI illness are accompanied by fewer~          ARI-related health care visits and less time lost to productive work (reduced~          absenteeism).~        4. Compare the potential benefits of mindfulness meditation to those from moderate~          intensity sustained exercise.~        5. Discern potential mediating factors and causal pathways that might help explain how~          these interventions lead to improved ARI illness-related outcomes.~      The investigators' preliminary findings suggest substantial benefit of these interventions~     in terms of reduced incidence, duration and severity of ARI illness, with corresponding~     reductions in days of work lost to illness. If the proposed research confirms these~     findings, there will be major implications for public and private health-related policy and~     practice, as well as for scientific knowledge regarding health maintenance and disease~     prevention.~   "
107155|NCT01654276|"~     This study is being done to evaluate whether the medication, febuxostat, can improve the~     degree of insulin resistance and other features of the metabolic syndrome (high blood~     pressure, elevated insulin levels, excess body fat around the waist, and/or high~     cholesterol) by lowering uric acid levels in the blood.~   "
107156|NCT01654263|"~     The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study~     will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two~     groups of participants (55 through 74 years of age). First group vaccine naïve participants~     will be open-label to receive a single injection of 0.5 mL PCV13. Second group of~     participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine~     (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each~     arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and~     six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of~     PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13~     for at least some of the vaccine serotypes among participants 55 through 74 years of age~     previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after~     study~   "
107157|NCT01654250|"~     The safety and efficacy of a chewable formulation of extended-release methylphenidate will~     be studied in children with ADHD~   "
107158|NCT01654237|"~     The hypothesis of this study is that there will be a variety of factors influencing the~     musculoskeletal complaints among workers of different sectors.~      Work-related musculoskeletal disorders (WMSDs) account for more than 30% of occupational~     diseases in the world. In order to organize the strategic actions that will be developed for~     the prevention of MSDs, it is essential to analyze in advance the peculiar situations of the~     different sectors of a workplace. The objectives of this study were to determine the~     prevalence of musculoskeletal complaints among workers in a medium-sized industry by~     comparing its sectors and to investigate the influence of occupational and non-occupational~     factors in the increase of complaints.~   "
107159|NCT01654224|"~     The purpose of the study is to compare the performance of two currently available influenza~     (flu) vaccines. This study will try and determine if the high dose flu vaccine provides~     protection that is the same or better than that of regular dose flu vaccine. Both the~     regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.~   "
107160|NCT01654211|"~     This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous~     danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on~     the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.~   "
107161|NCT01654198|"~     When patients with psoriasis develop joint pain, it is often hard to decide whether or not~     the pain is due to psoriatic arthritis (PsA). At this time, doctors use information from the~     history and physical exam to determine the diagnosis. X-rays, magnetic resonance imaging~     (MRI) and ultrasound have been used to help with the diagnosis but all three have~     limitations. A newer imaging technique, whole body Positron Emission Tomography/Computed~     Tomography (PET/CT) uses the idea that inflammatory cells take up sugar to locate~     inflammation in the body. Because patients with PsA have inflammatory cells in their joints~     and tendons, this type of scan allows the physician to take a picture of the whole body and~     locate inflammation. The investigators have found that some patients with psoriasis (but~     without arthritis) have inflammation in joints and tendons even before the patient has~     symptoms. In this study, the investigators will explore how well PET/CT works for assessing~     inflammation in patients with PsA. This would be a very exciting tool that could be used to~     find and treat inflammation before it causes damage or pain.~   "
107162|NCT01654185|"~     The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic~     breast cancer.~   "
107163|NCT01654172|"~     Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which~     have aroused interest due to population studies suggesting that diets high in these~     substances might reduce risks of heart disease. In the laboratory, these flavanols have been~     shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this~     ability of blood vessels to widen is now thought to play a central role in the complications~     of diabetes, novel ways to mitigate this are constantly being sought.~      The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot~     and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols,~     in subjects with diabetes, with and without peripheral neuropathy.~   "
107164|NCT01654159|"~     The main objective of this research is to assess visual function and optical performance of~     CE marked, implanted intraocular lenses to understand the individual factors that affect~     their performance and how these may be improved in future designs and to evaluate~     measurement techniques.~      All outcome measures will be captured 3-6 months after surgery~   "
107166|NCT01654133|"~     The purpose of this study is to evaluate visceral function, after endovascular repair of~     thoracoabdominal aneurysms.~   "
107170|NCT01654081|"~     The goal of this trial is to demonstrate the potential clinical benefit of irinotecan~     chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of~     irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of~     clinical benefit (objective response, disease stability, and time to progression) compared~     to historical controls that were not previously selected for ISG-15 expression.~   "
107171|NCT01654068|"~     The purpose of this study is to determine if Conformal High Dose Intensity Modulated~     Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal~     column. This study involves patients who have been diagnosed with metastatic cancer to the~     thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the~     area of concern. The goal is to prove that this is not only a safe form of treatment, but~     that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer~     coming back in the area that the investigators treat which may reduce the risk of developing~     symptoms like pain in the future.~   "
107172|NCT01654055|"~     Morphine is the gold standard for treatment of severe acute pain but it has a number of~     adverse effects.~      No study has so far managed to identify the morphine-induced adverse drug reactions. The~     primary objective of this study is to determine predictive factors of morphine-induced~     adverse drug reaction when it is used in emergency departments.~   "
107173|NCT01654042|"~     More than 2 million patients in North America are treated with warfarin - a blood thinner~     - to prevent blood clots in arteries or veins. The treatment has to be monitored with a~     blood test and the dose changed accordingly every 1-4 weeks. One third of the patients have~     very stable results and hardly ever have to change the dose. The investigators wish to show~     that the level of control of the treatment with warfarin in these very stable patients is~     not worse with 12-weekly testing. A pilot study the investigators performed indicated that~     12-weekly testing would be safe but this has to be confirmed in a large study. One third of~     patients taking warfarin have not had any changes in the dose for the past 6 months or~     longer. These patients will be asked about participation in the study. They will be~     randomized to testing and dosing every 4 or 12 weeks. Each patient is in the study until it~     ends, which will be minimum 1 year and can be up to about 4 years. The study is designed to~     show that 12-weekly testing does not significantly increase the risk for major bleeding or~     blood clots. The results would be important for a large number of patients. An increase of~     the interval between blood tests from 4 to 12 weeks would reduce the burden for these~     patients on life-long treatment considerably.~   "
107174|NCT01654029|"~     The most frequent consequence of a stroke is a communication impairment. When patients~     cannot articulate their needs, frustration and agitation are frequent responses, often~     resulting in poor optimization of post-stroke function. Staff's lack of knowledge of~     communication strategies exacerbates the problem. A key component of patient-centred care is~     the ability of staff to communicate in such a way that allows them to understand the~     patient's needs. Members of our team developed the patient-centred communication~     intervention (PCCI) targeting registered and unregulated staff caring for complex continuing~     care (CCC) patients with communication impairments post stroke. The purpose of the study is~     to examine if the PCCI results in improved patients' quality of life and in improved staff~     attitudes and skills in caring for patients with communication impairments.~   "
107175|NCT01654016|"~     Aim of the study:~      To investigate if there is a differences in expression of inflammatory markers in venous~     wall and blood among patients treated with Detralex and those not treated with Detralex~     (control group).~   "
107176|NCT01654003|"~     This study wants to compared the safety and efficacy of GDTs using standard pressure-related~     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in~     septic patients requiring emergency surgery.~   "
107177|NCT01653990|"~     A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to~     assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in~     healthy Chinese subjects.~   "
107178|NCT01653977|"~     This study compares the safety and efficacy of GDTs using standard pressure-related~     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in~     trauma patients requiring emergency surgery.~   "
107179|NCT01653964|"~     The primary objective of this work is to determine if half-dose Molecular Breast Imaging~     (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied~     can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI~     performed with 8 mCi Tc-99m sestamibi.~   "
107180|NCT01653951|"~     The results of the pre-pilot and pilot studies will be used to determine the feasibility of~     a fully powered trial that will test the effectiveness of two different approaches to~     diabetes management in an uninsured diabetic population who receives their care from a~     community based free clinic, namely nurse-directed interdisciplinary care management~     compared to peer-led self management. Effective programs for the uninsured diabetic will~     benefit both the individual and society by preventing serious illness, decreasing mortality~     and disability, decreasing medical debt, stimulating economic growth, improving business~     productivity, reducing job lock, decreasing health disparities, improving quality of life,~     and reducing cost shifting by decreasing uncompensated care. Findings will be generalizable~     to uninsured and insured patients across a wide spectrum of chronic conditions.~   "
107181|NCT01653938|"~     This is a randomized controlled trial of a CPR video decision aid in patients with advanced~     congestive heart failure (CHF).~   "
107182|NCT01653925|"~     The purpose of this study is to determine whether marine omega-3 fatty acids and~     5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk~     prostate cancer patients.~   "
107183|NCT01653912|"~     -  Dose-finding study of GSK2110183 administered in combination with carboplatin and~          paclitaxel to any subject with recurrent ovarian cancer.~        -  Safety and efficacy study of GSK2110183 administered in combination with carboplatin~          and paclitaxel to subjects with platinum-resistant ovarian cancer.~   "
107279|NCT01652794|"~     The purpose of this phase I study is to determine the highest dose of carboplatin and~     gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with~     gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This~     dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive~     different amounts of carboplatin and gemcitabine.~   "
107184|NCT01653899|"~     This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will~     receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556~     following their first islet transplant. Two pilot studies are proposed to establish the~     optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose~     of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day~     0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot~     studies will receive islet cell transplants under the University of Alberta's~     standard-of-care therapy.~      Secondary objectives include:~        1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain~          insulin independence after the first or subsequent islet transplant.~        2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate~          immunological protection against both allo- and autoimmunity of islet transplant~          recipients.~   "
107185|NCT01653886|"~     A pilot study was conducted to develop the study menus that were similar in appearance,~     aroma, and taste.~   "
107186|NCT01653873|"~     After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column.~     With analyzing of the images done right after the 1st vertebroplasty, we can define the~     parameters from different imaging and they can be predictors of the future fracture.~   "
107187|NCT01653860|"~     The purpose of this study is to investigate the effectiveness of the Brøset anger management~     model in reducing violent behavior amongst clients who are violent in intimate partnerships~     and who voluntarily seek help.~      Violence in intimate partnerships constitutes a serious problem worldwide and there is~     reason to believe that cognitive behavior therapy has some effect on the reduction of~     violent behavior. However, there are currently too few randomized controlled studies to~     conclude about the effectiveness of cognitive behavior therapy for this client group.~   "
107188|NCT01653847|"~     The immune system is the body's defense against infection and other disease. After~     transplantation, the body sees the new organ as foreign and tries to destroy or reject~     it. Immunosuppressive medications help to prevent the immune system from attacking a~     transplanted organ. The primary purpose of this study is to investigate the impact of two~     maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly~     selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil~     (group 2) as their immunosuppression medication.~      This study will enroll adult patients who are scheduled to receive a kidney transplant.~      The study is designed to understand the mechanisms of Everolimus in regards to kidney~     function in transplant recipients. The investigators hypothesis is that decreased exposure~     to Tacrolimus to the immune system will then translate in better renal allograft function.~   "
107189|NCT01653834|"~     This research study is being done to see if lymphocytes can be collected from patients with~     high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are~     cells that normally circulate in the blood and are an essential part of the immune system).~     The investigators goal is to store these and give them back to the patient after radiation~     is completed. This is part of a larger effort that will attempt to preserve the immune~     system from the effects of radiation and chemotherapy.~   "
107190|NCT01653821|"~     The aim of the study is to determine safety, tolerability and feasibility of unilateral and~     bilateral carotid body excision in patients with systolic heart failure and peripheral~     chemoreceptor hypersensitivity.~   "
107191|NCT01653808|"~     The purpose of this study is to compare the efficacy and biocompatibility of the Nipro~     Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line~     hemodiafiltration.~   "
107192|NCT01653795|"~     The aim of this randomized prospective study is to compare two single-use laryngeal mask~     airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators~     hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA~     Unique.~   "
107193|NCT01653782|"~     This randomized controlled study will evaluate the cost effectiveness of a yoga intervention~     compared to two evidence based programs; giving advice to stay active and guided exercise~     sessions. The first active program includes a six week standardized strength training~     program where the participants are personally instructed by a trained physiotherapist. The~     second active program is a six week standardized kundalini yoga program with group sessions~     twice a week lead by an experienced yoga instructor. Both programs consist of two exercise~     sessions per week and lasts for six weeks. After six weeks the participants are instructed~     to continue practicing their program twice a week on their own. The hypothesis are that a~     kundalini yoga program as an early intervention for Low Back Pain (LBP) is more cost~     effective than the two other interventions studied.~      Participants were recruited through the occupational health services and by advertisement in~     the local press. Study subjects eligible for inclusion were informed of the study either by~     health care personnel at the occupational health care centers or by a research assistant at~     the Karolinska Institutet. Subjects were informed that if they were eligible to participate~     in the study they would be given the opportunity to participate in one of three approaches~     for treatment of neck and back pain.~   "
107194|NCT01653769|"~     Surgery on the aorta can be associated with significant blood loss. Most commonly this is~     due to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with~     significant morbidity.~      One way to prevent bleeding is to use a special glue (sealant) after performing large~     connections on the aorta. The goal of this study is to compare the different methods~     surgeons use to stop/prevent bleeding.~      The study team will collect medical information about patients before, during, and after~     surgery on their aortas, including the methods used to prevent bleeding. This information~     may help doctors improve the way that they care for these patients.~   "
107195|NCT01653756|"~     The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on~     lung function in mild asthmatic subjects following allergen challenge.~   "
107196|NCT01653743|"~     This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare~     the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a~     single 5,000 international units (IU) intramuscular dose of urinary human chorionic~     gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or~     oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The~     primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by~     the ovulation rate.~   "
107197|NCT01653730|"~     Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen~     conserving devices (OCDs) provide greater patient accessibility and mobility during~     ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require~     no refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a~     lack of research on the clinical performance of the latest POCs that could help to determine~     their ability to maintain patients' oxygen saturations ≥ 90 % during exercise.~      Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen~     production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 %~     in patients with chronic lung disease during exercise.~      Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen~     saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic~     Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional~     oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different~     6-minute walk tests: the first will be a control walk performed with the participants'~     current oxygen system set at their prescribed exertional flow rate. Then, the participants~     will perform a walk test with each of the three POCs set at the units' maximum pulse dose~     setting. The order in which the participants use the POCs will be randomly assigned using a~     sequence generator.~      Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 %~     during exercise in patients with chronic lung disease with moderate to severe exertional~     oxygen desaturation.~   "
107198|NCT01653717|"~     The goal of this clinical research study is to find the highest tolerable dose of T cells~     that can be given in combination with standard chemotherapy to patients with CLL. The safety~     of this combination will also be studied.~      The T cells being used in this study are a type of white blood cell that will be taken from~     your blood and then genetically changed in a laboratory. The process of changing the DNA~     (the genetic material of cells) of the T cells is called a gene transfer. After the gene~     transfer is complete, the genetically changed T-cells will be put back into your body. These~     T cells may help prevent cancer cells from coming back.~   "
107199|NCT01653704|"~     The purpose of this study is to compare the effectiveness in learning crisis resource~     management (CRM) principles when being an active participant in simulation-based education~     versus being an observer participant. The investigators hypothesize that active participants~     will improve their CRM skills more than observer participants.~   "
107200|NCT01653691|"~     Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of~     hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy~     on children's burned scars has not been measured.~   "
107201|NCT01653678|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. The VITAL Hypertension ancillary study is being conducted among~     participants in VITAL and will examine whether vitamin D or omega-3 fatty acids are related~     to changes in blood pressure and hypertension.~   "
107202|NCT01653665|"~     Despite the introduction of multiple preventative measures rates of hospital acquired~     infection in the intensive care unit remain high. New approaches to tackling this problem~     are required. The neutrophil (a type of white blood cell) is the key cell fighting bacterial~     and fungal infection in the body. This research group has already shown that the majority of~     patients on intensive care have neutrophils which don't ingest germs effectively and are~     therefore less able to fight infection. These patients, whose white blood cells don't work~     properly, are much more likely to develop a second infection whilst in hospital (hospital~     acquired infection).~      Previous work done by this group has shown that by adding a drug called granulocyte~     macrophagecolony stimulating~      factor (GM-CSF) to a sample of blood from these patients in the lab, it is possible to~     restore the ability of the white blood cells to ingest bacteria and fight infection.~      This study will test whether it is possible to restore the capacity of patients' white blood~     cells to eat germs by giving them GM-CSF as an injection while they are on intensive care.~      The study will involve identifying adult patients on intensive care whose white blood cells~     don't work properly in this way. Patients taking part in the study will receive an~     injection, under the skin, of either the drug, GM-CSF, or a solution which will have no~     effect (placebo). The investigators will compare whether those patients who have received~     the GM-CSF injection have an improvement in the function of the white blood cells compared~     to those who don't.~      As well as looking at the function of the white blood cells the investigators will also~     study whether there is a difference in the rates of infection picked up in hospital between~     the two groups.~      This study is funded by the Medical Research Council.~   "
107203|NCT01653652|"~     The purpose of the current study is to evaluate the efficacy of administering a probiotic in~     adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.~   "
107204|NCT01653639|"~     This is a single dose, open-label, randomized, crossover study in subjects with severe~     Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY~     14-2222).~   "
107205|NCT01653626|"~     A matched pair cluster-randomized trial of this intervention package will be conducted in~     four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of~     the Republic of Guatemala, using the health clinic as the unit of randomization. No external~     intervention is planned for control facilities, although enhanced monitoring, surveillance~     and data collection will occur throughout the study in all facilities in the four districts.~      The package includes 3 interventions: 1) To train health care professionals in emergency~     obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ,~     multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a~     social marketing strategy that promotes institution-based delivery; and 3) To integrate the~     role of obstetric nurse and professional midwife in intervention communities to act as~     liaisons between traditional birth attendants (TBA) and public health units. A fourth,~     cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation~     to strengthen information systems and monitor perinatal outcomes throughout the two years of~     the study.~   "
107206|NCT01653613|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This laboratory study is looking into genes in samples from younger patients with~     acute lymphoblastic leukemia (ALL).~   "
107417|NCT01650857|"~     Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC)~     and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient~     pulmonary rehabilitation (PR) improves PC, BC and HRQOL.~   "
133759|NCT01304251|"~     The purpose of this study is to determine the effect of short-term fasting on tolerance to~     adjuvant chemotherapy in breast cancer patients~   "
107207|NCT01653600|"~     The nitinol stent has proven superior primary patency than balloon angioplasty in~     superficial femoral artery lesions. Recent stent design improvements focus on decreasing~     stent fracture rates which can negatively impact patency rates by rearranging strut~     alignment. In the literature, however, prospective, randomized, controlled, clinical trial~     for comparison of stent fracture and primary patency between different nitinol stents has~     never been performed except one study; SMART versus Luminexx stent named SuperSL trial.~     LifeStent is similar to S.M.A.R.T. stent in the design consisted of the peak-to-valley~     connected with S-shaped bridge but is different in lesser bridge (4 bridge vs. 6 bridge),~     large cell size on stent ends, and larger cell size than S.M.A.R.T. On the other hand,~     Recent meta-analysis has shown that the efficaty of cilostazol in the atherosclerotic~     femoropopliteal lesion was proven. However, still specific data regarding a variety of~     antiplatelet regimen in implanted femoropopliteal lesion are limited. Upto date, in the~     literature, never has never been performed the clinical trial for optimal duration of~     cilostazol use in the patient undergone stent implantation for femoropopliteal lesion. Thus,~     The purpose of our study is to examine and compare Primary patency and stent fracture~     between different two-nitinol stents (S.M.A.R.T. CONTROL versus Lifestent) in~     femoropopliteal arterial lesion and to examine and compare the optimal duration of~     cilostazol use.~   "
107208|NCT01653587|"~     Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive~     strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular~     closure device would decrease the prevalence of vascular complications at puncture site,~     reaching the non-inferiority criterion when compared to the radial access.~   "
107209|NCT01653574|"~     The hypothesis of this clinical research study is to discover if the study drug Famitinib~     Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.~   "
107210|NCT01653561|"~     The hypothesis of this clinical research study is to discover if the study drug apatinib can~     shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer.~   "
107211|NCT01653548|"~     The aim of the present project is to develop and evaluate a novel and brief method of~     generalizing habituation (i.e., calming down after being upset) from an original learning~     context in the laboratory to other contexts inside and outside the laboratory. Specifically,~     the primary aim of this project is to evaluate whether novel habituation reminders (HRs)~     introduced following personally-relevant emotional stressors reduce acute negative emotions~     and psychological distress outside of an original learning context. Using a team of basic~     and applied scientists, over 4 years the investigators expect to screen 420 adult~     outpatients to enroll 250 study participants who have extreme difficulties with emotion~     regulation. These 250 participants will be randomly assigned to one of eight experimental~     groups, with the experimental design leading them through 1 or 2 of 3 project experiments.~      Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222~     participants were eligible and began the study. Out of the 222, 210 completed the study (as~     opposed to the desired 250).~      Experiment 1 will evaluate whether novel auditory HRs following personally-relevant~     emotional stressors differentially reduce psychological distress and negative emotions (via~     self-report and psychophysiology), compared to no HRs, within the same and different lab~     contexts after a 1 week delay. Experiment 2 will evaluate whether HRs differentially reduce~     negative emotions, psychological distress, difficulties with emotion regulation, and~     psychiatric symptoms, compared to sham sounds outside the laboratory across a 1 week period,~     using 8x daily assessments of distress and emotions and automated HRs/shams when acute~     negative emotions are present. An automated server and cellular phone system will be used to~     assess distress and emotional states and to deliver HRs/shams. Experiment 3 will examine the~     feasibility, acceptability, and preliminary effect size estimates when participants~     self-initiate the use of HRs in their daily lives across a 2 week period when acute negative~     emotions are present. The specific randomization rules across the 8 groups are explained in~     detail in the full protocol .~      Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2)~     discussing and hearing self-reported distressing events. Initial analyses will focus on the~     success of randomization to groups. The investigators will examine group differences on~     possible covariates (e.g., demographic variables) and those that are different across~     conditions will be used as covariates. Preliminary analyses will examine distributional~     properties of primary outcome measures and correlations among outcome measures and possible~     covariates. The investigators will set alpha at .05 for all analyses of primary hypotheses.~     To examine the influence of psychiatric symptoms (compared to the HR) on primary outcomes,~     the investigators will examine the relationship between baseline clinically relevant~     psychiatric variables (e.g., symptom severity) and changes in SUDS, emotional arousal, and~     clinical outcomes over time and if appropriate include these variables in primary analyses.~     Full data analytic plans are described in the full protocol.~   "
107212|NCT01653535|"~     The primary aim of this project is to evaluate the effects of a comprehensive intervention~     to prevent severe and chronic conduct problems in a sample of children selected as high-risk~     when they first entered school. It is hypothesized that the intervention will have positive~     effects on proximal child behavior in middle school, and high school affecting long-term~     adolescent outcomes such as conduct disorder, juvenile delinquency, school dropout,~     substance use, teen pregnancy, relational competence with peers, romantic partners and~     parents, education and employment and social and community integration.~   "
107213|NCT01653522|"~     The purpose of this study is to determine the effects of triptans and doxycycline on~     neuroinflammatory markers in acute migraine.~   "
107214|NCT01653509|"~     This study will treat approximately 24 participants who experience cold sores. Patches will~     be applied to the cold sore for up to ten days, and the symptoms will be measured during~     daily clinic visits using non-invasive measurement techniques.~   "
107215|NCT01653496|"~     The purpose of this study is to prospectively evaluate the overall compliance to the~     enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer~     surgery.~   "
107216|NCT01653483|"~     This is a randomized, double-blind, placebo-controlled, repeat dose, 2-period, incomplete~     block, crossover, safety and pharmacokinetic (PK) study to evaluate 3 once-daily doses of~     umeclidinium (GSK573719; UMEC) in adolescent asthma subjects aged 12 through 17 years,) who~     are currently using asthma medications that do not contain inhaled corticosteroids~     (non-ICS). The objectives are to investigate safety and tolerability, and PK after a 7-day~     (+2) repeat once-daily dose of UMEC (15.6, 62.5, and 250 mcg) in asthmatic adolescent~     subjects. Safety endpoints will include reported adverse events, vital signs, ECGs, clinical~     laboratory tests, and rescue albuterol use. The PK endpoints will include serial PK (plasma~     and urine) concentrations and derived parameters.~      Twenty four subjects will be randomized to participate in the study for up to 7 weeks~     (including: an initial screening visit, a 7 to 14-day run-in, and 2 treatment periods each~     of 7 (+2) day duration, with a washout period of 7-14 days between treatment periods). There~     will be a Follow-up Visit approximately one week after the end of the second treatment~     period. Subjects will refrain from using rescue medication for 4 hours prior to any clinic~     visits, unless for emergency.~      During each treatment period, study medication will be taken once in the morning until the~     morning of Day 7 (+2 days) when subjects will return to the clinic for study assessments and~     take the last dose of study medication. On Day 7 (+2), subjects will remain in the clinic~     overnight for serial assessments (ECG, and PK plasma and urine samples over the 24-hours).~   "
107217|NCT01653470|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in~     combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus~     Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic~     solid tumors~   "
107218|NCT01653457|"~     Fibromyalgia (FM) is a chronic rheumatic disease of high prevalence and great clinical~     impact. However, the treatment for FM has limited efficacy, with an effect size of about~     0.5. Recent studies have found raised levels of glutamate in the insula, hippocampus and~     posterior cingulate cortex regions of the brain. This has led a number of authors to suggest~     the usefulness of glutamate blocking drugs in the treatment of FM.~      Aims: To evaluate the efficacy of memantine in the treatment of pain and other symptoms of~     FM and to assess its efficacy in reducing brain glutamate levels in patients with FM.~     Material and methods: Randomized controlled trial, of six months duration (including a dose~     adjustment period of one month). 60 patients with FM will be recruited for inclusion in the~     study upon fulfillment of selection criteria, and they will be randomized in two groups: A)~     Treatment group (n=30), will receive 20 mg of memantine o.d ; B) Control group (n=30) will~     receive placebo. The main objective is to assess the efficacy of memantine in the treatment~     of pain (pain threshold, pain perception) and other symptoms in fibromyalgia (cognitive~     state, health status, state of anxiety and depression, quality of life and perceived~     improvement. Discussion: There is a need for the development of innovative and more~     effective alternatives for the treatment of FM. This clinical trial will determine whether~     memantine can be considered as an option in the treatment of FM patients.~   "
107219|NCT01653444|"~     The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119~     (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease~     patients.~   "
107220|NCT01653431|"~     The study will examine whether the effects of computerized brain training are enhanced when~     training is combined with mild brain stimulation in patients with mild cognitive impairment.~     We hypothesize that this combination will produce greater improvements in cognitive~     functioning than computerized brain training alone.~   "
107221|NCT01653418|"~     BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used~     conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell~     transplantation. Since these components are all effective in myeloma and bortezomib has~     shown promising results in the transplant setting, here the investigators propose a phase II~     study to investigate the combination of bortezomib and BEAM as a new conditioning regimen~     for patients who relapse or progress after the first autologous transplantation and for whom~     a second autologous transplant is considered.~   "
107222|NCT01653405|"~     Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood~     clots (including strokes). Too much anticoagulation increases the risk of serious or even~     fatal bleeding, and too little anticoagulation fails to protect the patient against blood~     clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the~     therapeutic range, the range within which they are protected from clots but not at excessive~     risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following~     several relatively simple procedures, including following-up promptly when patients are out~     of range and focusing on educating and supporting patients with poor control. In this study,~     the investigators will promote these practices at the anticoagulation clinics of the New~     England VA region, with a goal of improving anticoagulation control.~   "
107223|NCT01653392|"~     The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine~     during pregnancy is independently associated with adverse maternal, pregnancy, or infant~     health outcomes.~   "
107224|NCT01653379|"~     This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with~     end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to~     identify an appropriate starting dose of DP001 to be used in subsequent studies in this~     population and for evaluation of pharmacokinetics of DP001 in ESRD patients.~   "
107225|NCT01653366|"~     This study is a randomized prospective clinical trial of women with metastatic breast~     cancer. The purpose of the study is to test if an intervention of regular physical activity~     review and physical activity goal setting will allow the subjects to achieve a moderate~     increase in physical activity of 6,000 steps per week. The physical activity review will~     consist of weekly telephone call to inquire about symptoms and to set physical activity~     goals. The study will also look to see if the goal setting intervention will affect the time~     to progression, change in BMI, and quality of life. Quality of life will be measured by~     answers to questionnaires provided to subjects at regular intervals during the course of the~     study. Finally, the study will examine the impact of physical activity on expression of~     tumor molecular molecules, insulin levels, and estradiol levels.~      Through an intervention of regular physical activity review and goal setting, the~     investigators hypothesize that a moderate increase in level of physical activity of 6000~     steps per week or more can be obtained by patients with metastatic breast cancer who receive~     a goal setting intervention. The investigators propose that those who are able to achieve~     and maintain greater than or equal to 22500 steps per week will demonstrate biologic and~     molecular differences compared to those who are not able to achieve that level of physical~     activity. The investigators expect that people who are more active will have longer to~     progression.~   "
107226|NCT01653353|"~     Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our~     study checks compliance with Swiss federal recommendations on vitamin D and calcium~     supplementation among residents of a Swiss nursing home. A peer physician-applied~     recommendation on compliance with the federal recommendations with individual evaluation of~     the residents will be sent to the physicians in care. After one year, data will be collected~     again.~   "
107227|NCT01653340|"~     The purpose of this study is to assess short- and long-term safety, tolerability and~     efficacy of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering~     from chronic migraine refractory to conventional medical therapy.~   "
107228|NCT01653327|"~     -  The primary objective is to determine the reduction in pain score by ketamine mouthwash~          compared to placebo in head and neck cancer patients with refractory mucositis.~        -  The secondary objectives are to describe the duration of analgesia and adverse effects~          associated with ketamine and placebo.~   "
107229|NCT01653314|"~     The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg~     (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.~   "
107230|NCT01653301|"~     -  INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer~        -  LEADER study: to evaluate the impact on local control of local excision~   "
107231|NCT01653288|"~     This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered~     online to children who have experience an acute medical event.~      The core study hypotheses are that children receiving the intervention will (1) endorse~     fewer maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more~     support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up,~     and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health~     related quality of life (HRQOL) at 12 week follow-up.~   "
107232|NCT01653275|"~     We propose a 24 week clinical research trial (12 week observational period followed by 12~     week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as~     the primary outcomes.~   "
107233|NCT01653262|"~     Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in~     subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such~     side effects; as well as the efficacy, safety and tolerability of BRV. No statistical~     hypothesis testing will be performed.~   "
107234|NCT01653249|"~     This study will consist of 300 women aged 18-50 years. The study will show that a new~     therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition~     called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause~     cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a~     synthetically made fragment of HPV protein called E6 and yeast extract called Candin®.~     Previous studies have revealed that immune response to E6 is important in fighting HPV. We~     also know that injecting Candin has anti-HPV effect since it has been used to treat common~     warts which are caused by different types of HPV. The current standard treatment for HSIL is~     loop electrical excision procedure (LEEP). The immune system is the part of the body that~     fights infection and cancer. This research study will also examine the immune response to~     the vaccine and its effectiveness in regressing HSIL. Volunteers would be eligible to enroll~     in the study if they have had a recent Papanicolaou (Pap) smear result indicating HSIL or~     Cannot rule out HSIL, and if they meet the inclusion/exclusion criteria. Subjects will be~     eligible to receive vaccinations if biopsy confirms HSIL. A series of four vaccinations will~     be given roughly 3 weeks apart, and LEEP will be performed at the end of the study~     approximately 12 weeks after the last vaccination.~   "
107235|NCT01653236|"~     Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with~     genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving~     sustained viral response compared to standard treatment alone.~   "
107236|NCT01653223|"~     Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It~     was also reported that statins could protect endothelial function and cardiac function~     during coronary artery bypass graft. We recent found simvastatin reduced myocardial injury~     during noncoronary artery cardiac surgery in single medical center. We further investigate~     that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery~     with cardiopulmonary bypass and improve cardiac function with long term use postoperatively~     in two medical centers.~   "
107237|NCT01653210|"~     This overall research goal will be to develop a mobile-based module to improve glycemic~     control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This~     module will run on an Android Operating System (OS) and will be available as: (i) a~     stand-alone application and (ii) an important additional component to a larger system, the~     Diabetes Assistant (DiAs) - a mobile-based medical platform for diabetes applications. This~     proposal aims to build one such application or module targeting the improvement of diabetes~     control in younger women who experience glucose variation related to their menstrual cycle.~   "
107238|NCT01653197|"~     The mailer will encourage those who are due for mammograms, colonoscopies, blood pressure or~     cholesterol tests to receive the appropriate test. This particular mailer will only be sent~     to Evive clients in need to the test in question. The research will examine differences in~     follow-through on this recommendation among the targeted population over the 3-12 month~     period following the mailing as a function of experimental condition.~   "
107239|NCT01653184|"~     The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with~     age-related macular degeneration.~   "
107240|NCT01653171|"~     The purpose of this study is to determine whether premedication with Simethicone or~     Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy.~   "
107241|NCT01653158|"~     This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamic effects of escalating doses of CP 751,871 given in combination with~     docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable~     treatment option.~   "
107242|NCT01653145|"~     The purpose of this trial is to examine the metabolic and behavioral effects of a positive~     energy balance induced by adding food to the usual level of activity.~      It is hypothesized that: 1) food intake will not differ significantly after 2 days of~     positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are~     low in energy density, and 2) food intake will be higher after a positive energy balance~     induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.~   "
107243|NCT01653132|"~     This study is being conducted this study to determine whether injections of Xeomin®, a type~     of botulinum toxin into the glands that produce saliva (one pair just below and in front of~     the ear and the other just under the jaw line) are safe and effective to treat excessive~     saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.~   "
107244|NCT01653119|"~     The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin~     on recurrent events in patients with established DM who is admitted for an ACS.~   "
107245|NCT01653106|"~     The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and~     long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients~     that receive high dose melphalan for bone marrow transplantation commonly develop~     significant mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal~     of this study is to scientifically determine (using randomization and a larger sample size)~     if a short-term schedule is as effective as the standard long-term schedule in preventing,~     or minimizing the symptoms involved with oral mucositis. The study is also trying to~     determine the best dose of melphalan and how patient's body breaks down melphalan and will~     obtain blood through central venous catheter to measure the amount of melphalan in patient's~     blood at specific times after the melphalan is infused~   "
107246|NCT01653093|"~     In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which~     is a procedure to take pictures of body structures by using a strong magnetic field and~     radio waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher~     Tesla number means the magnet has stronger pull. Standard magnetic resonance imaging of the~     prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna)~     inserted into the body due to the limitations using an external body coil at this magnet~     strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla~     of creating a signal twice as strong that can be received by the antennas, resulting in~     better pictures. The goal of this study is to make the MRI procedure more comfortable for~     patients by using an external coil instead of an endorectal coil. With this study,~     researchers also want to help patients' health care teams, the surgeons in particular.~     Researchers will assess the impact of prostate MRI, without an endorectal coil, done at 3~     Tesla and with an external body coil on helping doctors decide which approaches to disease~     therapy might be best for patients as well as correlate patients' study images with all~     other clinical imaging~   "
107247|NCT01653080|"~     This study is being done due to a new imaging method that may help others in the future to~     improve evaluation of diseases in the eye and eye socket and to help make a decision~     concerning best treatment of the disease. Previous studies suggests that dynamic contrast~     enhanced MRI is ideally suited to show small structures in the eye and eye socket as well as~     to provide information about the eye socket such as blood circulation. This research may~     also provide information about the likelihood of the tumor spreading from the eye into other~     organs as well as correlate the study images with all other clinical imaging~   "
107248|NCT01653067|"~     The STORM-trial consists of two parts. In the part I (dose escalation of Temsirolimus) the~     primary objective is to establish a maximum tolerated dose of Temsirolimus in combination~     with Rituximab and DHAP. Secondary objective is to prove ability to mobilize stem cells in~     patients scheduled to high dose therapy.~      In the part II (full target dose) the primary objective is to evaluate the ORR in patients~     with relapsed diffuse large B cell lymphoma (DLBCL). The secondary objective is to evaluate~     progression free survival (PFS), overall survival (OS) and Toxicity.~   "
107249|NCT01653054|"~     The rationale for this study is that the risk of anal dysplasia in patients with~     inflammatory bowel disease as compared to the general population has yet to be investigated~     prospectively. There have only been a few articles examining this relationship - preliminary~     results have suggested that patients with IBD are at increased risk for abnormal anal pap~     smears. As high grade anal dysplasia is strongly associated with an increased risk of anal~     carcinoma, it is important to identify all high risk groups that might benefit from routine~     screening. This pilot study aims to determine whether patients with IBD in our Bronx~     population have an increased risk of abnormal anal Pap smears. We hypothesize that there~     will be an increased incidence of abnormal anal pap smears in patients with IBD who have~     been treated with immunosuppressants, given that chronic immunosuppression is related to~     increased HPV infection.~   "
107250|NCT01653041|"~     Recipients from living donors kidneys HLA-identical were lower risk for acute rejection,~     graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen~     for this population.~      Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest~     incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the~     reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated~     with chronic use of these agents. Moreover, the use of EVR is associated with increased~     incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing~     that proteinuria may be the first indication of recurrence of the underlying renal disease,~     detailed information about the patient's medical history and histological analysis of the~     graft may contribute with additional knowledge in this area.~      The aim of this prospective, open, single arm study that will be performed only in the~     Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in~     recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive~     regimen. This will include 100 recipients of first or second kidney transplant from a living~     donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a~     period of 12 months.~   "
107251|NCT01653028|"~     This phase II trial studies how well alisertib works in treating patients with sarcoma that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
107252|NCT01653015|"~     There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional~     benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to~     those who are unvaccinated through herd immunity. The goal of this randomized clinical trial~     is to determine whether immunizing children in Hutterite colonies with LAIV can provide~     increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite~     colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or~     LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected~     by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes~     will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use,~     absenteeism.~   "
107253|NCT01653002|"~     A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer~     tissue. The purpose of this study is to determine whether the assessment of the~     hypermethylation level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy~     makes a contribution to lung cancer staging.~   "
107296|NCT01652573|"~     X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United~     States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone~     call FGF23, which makes the body waste phosphate. This study is designed to determine if~     nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and~     reduce phosphate wasting in patients with XLH. In this study the investigators will:~        1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels~          of FGF23 in patients with XLH.~        2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH.~        3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D~          and calcium absorption from the intestine.~        4. Make sure that nasal calcitonin is safe and well tolerated.~   "
107254|NCT01652989|"~     The PILI @ Work project is a 5 year randomized control trial to adapt a weight loss program~     for the employees of Native Hawaiian-serving organizations in Hawai'i. The study has two~     specific aims:~      Specific Aim 1: To adapt and implement a weight loss and weight loss maintenance program in~     Native Hawaiian-serving organizations, working with employee representatives to determine~     how the intervention can be best implemented with employees at the worksites. Specific Aim~     2: Among employees participating in the program, to test whether weight loss maintenance~     program in DVD format is as effective as the weight loss maintenance program in a group face~     to face format in maintaining weight loss for employees who complete weight loss program.~      The investigators hypothesize that the PILI @ Work interventions can be effectively adapted~     and implemented in a worksite settings with active participation by employees and employers.~     The investigators also hypothesize that overweight (BMI ≥ 25) and obese (BMI ≥ 30) employees~     who complete weight loss portion of the intervention, and are randomized to received the~     weight loss maintenance intervention via DVD will have similar success at maintaining weight~     loss compared to those randomized to PILI Maintenance in group meetings or settings. The~     investigators hypothesize that will will also be true for physical functioning,blood~     pressure, daily self-weighing, low to moderate fat and low calorie diets, and daily physical~     activity.~   "
107255|NCT01652976|"~     The purpose of this research study is to determine if the study drug, dasatinib, given in~     combination with 5-Fluorouracil, leucovorin and oxaliplatin (FOLFOX) will work against~     metastatic pancreatic cancer.~      Dasatinib is a Food and Drug Administration (FDA) approved drug for treating chronic~     myelogenous leukemia and acute lymphoblastic leukemia, however it is not currently approved~     for use in the treatment of pancreatic cancer.~   "
107256|NCT01652963|"~     The proposed research aims to investigate whether people with intellectual disabilities are~     able to understand and apply the theoretical principles of cognitive behaviour therapy (CBT)~     regarding the interaction between events, beliefs and emotions. Two studies are designed to~     assess and train the ability to link events, beliefs and emotions.~      Study 1 pilots computer-based tasks to assess the ability to link events, beliefs and~     emotions as well as a computer-based training programme aimed to link events and emotions.~     Task and training stimuli will be presented by line drawings to investigate whether a~     picture-based approach can reduce the impact of verbal ability on task performance. Training~     effectiveness is evaluated compared to a no-training control task.~      Study 2 compares the line drawings-based approach of Study 1 to a photographic approach to~     investigate whether the use of photographs can increase training effectiveness and further~     reduce the impact of verbal ability. It is hypothesised that the high reality value of~     photographic task stimuli, as compared to line drawings, will have positive effects on the~     assessment and training of CBT skills. It is anticipated that the findings of this research~     will improve our ability to help people with intellectual disabilities receive CBT.~   "
107257|NCT01652950|"~     Background: Physical inactivity and increased sedentary activity are major lifestyle factors~     that contribute to increasing burden of disease globally. There is evidence that the rise in~     prevalence of non-communicable diseases (NCDs) was largely responsible for growth in private~     insurance spending between 1987 and 2002 in the USA. There is renewed interest by health~     plans to implement incentivized health promotion programs, in an effort to change health~     behavior and thereby reduce health care costs related to NCDs. However, the literature on~     the role of incentives and rewards in influencing physical activity behavior, specifically,~     is relatively sparse, and the field of behavioral economics applied to health behavior is~     relatively new.~      Most studies that have been conducted typically report findings with limited, well-defined~     incentives that are offered for a short period. These studies generally have shown a~     moderation in health care costs compared to non-participants. In a cross-sectional study of~     approximately 940,000 members of a national private health insurance, Discovery Health, the~     investigators have previously demonstrated a significant and inverse relationship between~     levels of participation in fitness-related activities and medical claims associated with~     hospital admissions. More recently, in a retrospective, longitudinal analysis over 5 yrs,~     amongst more than 300,000 members, the investigators found that participation in~     fitness-related activities increased over a 5-yr period and was associated with a~     significantly lower probability of hospital admissions and inpatient claims costs.~      Aim: The current study primarily aims to prospectively compare the effectiveness of diverse~     incentives on physical activity behavior, monthly over a 12 month period following~     registration, in a cohort of newly-enrolled, adult members of the Vitality health promotion~     program.~      Study sample and random allocation to groups: Newly enrolled adult members of the Discovery~     Health medical plan and who have, themselves, prospectively registered for the Vitality~     health promotion program, will be eligible for the study, and will be invited to participate~     by Discovery Health. This recruitment, enrollment and random allocation to groups will be~     initiated via a web-based email communication, from Discovery Health, over a period of 5~     months. A final sample of 9000 adult members will be randomly allocated by Discovery~     Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and~     followed each month for a period of 12 months.~      The intervention arms include a Control group, in which members will be offered no~     additional incentives, other than the existing incentives, to engage in all points-earning~     physical activity. There will also be a Communication Group, in which members will be~     offered the base program and, in addition, will be sent bi-weekly communications by~     alternating email and text messaging which included information on the importance of~     physical activity, tips on accumulating fitness points on the base program, a status~     update of points earned and information on benefits and rewards offered.~      The incentive arms are comprised of a Direct Payment Group, a Charity Incentive Group, a~     Lottery Pay-out Group, and a Choice Group. In each case, members will be offered the base~     program and supplementary communication described above. In addition, individuals will be~     offered the equivalent of one of four possible incentive amounts depending on the level of~     participation in fitness-related activities. Enrollment will be over a period of 5 months,~     and the intervention will take place over a period of 12 months, following registration,~     with a monthly pay-out for the incentive arms of the trial.~      The following outcomes of interest will be measured:~        -  Number of new participants (registration) in the fitness programs of Vitality~        -  Points earned, as a proxy for levels of participation, for engaging in physical~          activity (gym visits)~        -  Self-reported measures of physical activity levels, smoking and healthy eating~          behaviors~        -  Health care claims (de-personalized) for the 12 month period following the 12 months~          intervention~        -  Survey of attitudes to incentives and rewards in the post-study questionnaire~      Ethical considerations: Ethics approval has been obtained from the University of Cape Town/~     University of Pennsylvania Research Ethics committees. Consent will be obtained from each~     subject, who agree to participate or 'opt out' and agree that their medical claims and~     utilization data may be examined in a de-personalised manner according to their group, and~     level of participation. Further, should a member choose to drop out in the course of the~     study, or refuse to participate, there will be no adverse impact on their medical plan~     coverage and they are free to withdraw without prejudice at any time during the course of~     the study.~   "
107258|NCT01652937|"~     Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with~     Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying~     Antirheumatic Drugs (DMARDs).~   "
107259|NCT01652924|"~     The purpose of this study is to determine whether mechanical ventilation with facial mask~     during induction anesthesia in the population of 1month to 14years is associated with less~     risk of gastric insufflations as compared with manual ventilation.~   "
107260|NCT01652911|"~     This is an open-label, single arm, non-randomized safety and efficacy study, where~     participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the~     subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into~     the Cell Pouch™.~      The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in~     adult participants with Type-1 diabetes receiving islet transplantation for the first time.~      Secondary objectives are the following:~        1. To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted~          with islets into the Cell Pouch™ who achieve and maintain insulin independence after~          islet transplantation.~        2. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate~          immunological protection against both allo- and autoimmunity of islet transplant~          recipients.~        3. To determine through retrospective analysis comparative metabolic function and~          engraftment efficiency using patients undergoing standard intraportal islet~          transplantation under the current alemtuzumab standard of care protocol.~   "
107261|NCT01652898|"~     The study consists of a Pilot Phase (to assess safety and the local tolerability of highest~     AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety~     and tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement~     of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG,~     blood pressure and adverse events).~   "
107262|NCT01652885|"~     The purpose of this study is to investigate the safety, tolerability, and systemic exposure~     of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.~   "
107263|NCT01652872|"~     A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with~     chronic kidney disease and not on dialysis will be randomized 1:1 to 1 of 2 dosing~     strategies to evaluate the proportion of subjects receiving at least one red blood cell~     transfusion. In the Hb-based titration group, darbepoetin alfa doses will be titrated to~     maintain hemoglobin (Hb) ≥ 10.0 g/dL. In the fixed dose group, subjects will receive a fixed~     dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb~     concentrations will be blinded. Subjects will be followed for approximately 2 years from the~     date of randomization.~   "
107264|NCT01652859|"~     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different~     liposomal amphotericin B injections after single IV infusion at the same dose in normal~     healthy subjects.~   "
107265|NCT01651806|"~     Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more~     efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA)~     cases. This includes having a greater impact on decreasing blood loss without increasing the~     occurrence of adverse thromboembolic events in patients undergoing primary, elective total~     knee arthroplasty.~      Secondary - TA will decrease blood loss more effectively in women than in men undergoing~     this procedure.~   "
107266|NCT01651793|"~     The purpose of this study is to determine which substances in cocoa produces changes in~     mental energy. This is a double blind study. The primary outcome measures are performance on~     tasks of sustained attention (serial subtract, continuous performance test and Bakan task)~     at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile~     of mood state), and ratings of motivation to perform cognitive tasks. The assigned~     interventions are the following:~      Active comparator 1 High flavanol, high theobromine, high caffeine, single dose~     administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low~     caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol,~     high theobromine, high caffeine, single dose administration in hot water vehicle Active~     comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot~     water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose~     administration in hot water vehicle~   "
107267|NCT01651780|"~     This is an international, multicenter, open-label, randomized controlled trial. All patients~     undergoing transfemoral TAVR at the participating centers will be eligible. All sites will~     initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter~     patients will be randomly assigned to either standard dosing of bivalirudin or UFH as~     control. The 2 roll-in cases per site will constitute the feasibility cohort that will be~     followed and analyzed separately. Patients will undergo TAVR according to current standard~     of care practices at the treating centers. Use of antiplatelet agents pre, during, and post~     procedure, and possibly oral anticoagulants post procedure, will be according to the sites'~     standard practice. ALL available data will be collected in the eCRF prospectively~   "
107268|NCT01651767|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what~     the body does to the medication) and antiviral activity of JNJ-47910382 when administered in~     different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.~   "
107269|NCT01651754|"~     Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem,~     impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from~     severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the~     underlying physiology remains unclear. The presence of an underlying immunological problem~     has been suggested as an explanation for PCF and CFS. The aim of this study is to compare~     the humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS~     patients, non-fatigued cancer survivors, and healthy controls.~      PCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender~     matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included~     for comparison. Antibody responses will be measured at baseline and at day 21 by a~     hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7~     by lymphocyte proliferation, activation, and cytokine secretion.~   "
107270|NCT01651741|"~     The aims of this study are to investigate the effect of seaweeds which is one of the main~     ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of~     healthy subjects.~   "
107271|NCT01651728|"~     The objective is to assess the effect of simvastatin on immunology, inflammatory, and~     coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is~     mortality event.~      The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly~     with pneumonia.~   "
107272|NCT01651715|"~     The purpose of this study is to determine whether early self-treatment with homeopathic~     dilutions of oral antibodies to a key-protein of the immune system are effective and safe in~     the treatment of viral upper respiratory tract infections~   "
107273|NCT01651702|"~     Three dimensional anatomical mapping is an established method facilitating ablation of~     cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster,~     Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA).~     These two systems has been compared in only a few studies. Recent technical advances~     resulted in the development of new versions of both systems. To the best of the~     investigators knowledge no studies have been performed for direct comparison of the newer~     versions of these two systems. The aim of the study to compare two systems for the use in~     the ablation of complex arrhythmias.~   "
107274|NCT01651689|"~     Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in~     horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although~     in Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian~     just had only one study and the data was more differently from West Asian and whites. Then~     this study was performed to evaluate hair density in Thais, and compared to previous study.~   "
107275|NCT01651676|"~     The purpose of this study is to estimate the capacity of the auto-questionnaire of quality~     of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary~     disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15~     days) during the implementation of a LABD (Long-acting bronchodilator) treatment.~      The main objective is to compare the total Score of the VQ11 auto-questionnaire before and~     after LABD. A decrease of 5 points of the total score mimicking an improvement in the~     quality of life linked to health, specifically in the COPD.~   "
107276|NCT01652833|"~     To ensure the appropriate administration of Vectibix for the treatment of mCRC with~     wild-type KRAS in real-world practice, it is important to understand the awareness of~     practicing oncologists regarding the correct indication and appropriate administration of~     Vectibix. It is also critical to monitor changes in oncologists' awareness and practice~     between the different rounds of the study.~   "
107277|NCT01652820|"~     Randomized study in 2 arms, without any masking in patients with non small cell lung cancer,~     histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA,~     according to the TNM classification of the American Joint Committee for cancer. In one arm~     will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed~     by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by~     concurrent radiotherapy with carboplatin-docetaxel~   "
107278|NCT01652807|"~     This study looks at an 8-week hatha yoga intervention for women reporting high levels of~     stress, a risk factor for various forms of psychopathology.~   "
107297|NCT01652560|"~     - The purpose of this study is to evaluate the efficacy and safety of the application of~     bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.~   "
107280|NCT01652781|"~     Approved dosing schedule of azacitidine for myelodysplastic syndrome (MDS) is 75 mg/m^2/day~     subcutaneous for 7 consecutive days every 28 days, which is based on the data from standard~     chemotherapy regimen and a Phase I safety clinical trial. Since the optimal dosage of this~     drug has not been found yet, it remains as a subject of clinical study that needs to be~     examined. If initial toxicity is minimized by developing dosage/regimen that replaces the~     standard therapy, it will be possible to provide continuous treatment with increased~     convenience by patients and treating physicians as well as improvement for safety in elderly~     patients or those with serious cytopenia. In addition, it is expected to lead to a better~     response by strictly keeping a treatment schedule.~      Recent US study showed that 5-day regimen showed similar treatment results, but~     retrospective data from Spain showed lower response rate in 5-day regimen. Considering the~     recent circumstances around dosage and schedule of azacitidine in lower risk MDS, a Phase II~     clinical trial is planned in lower risk MDS patients in order to explore the efficacy in~     5-day treatment by comparing prospectively with 7-day standard regimen.~   "
107281|NCT01652768|"~     The purpose of this pilot study is to investigate the feasibility of an early palliative~     care intervention (PRESENCE: Providing Resources Education, Support, and Enabling New brain~     tumor patients to Cope Effectively) and the effect of the intervention on patient and~     caregiver distress.~   "
107282|NCT01652755|"~     To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of~     acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.~   "
107283|NCT01652742|"~     To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single~     dose administration.~   "
107284|NCT01652729|"~     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once~     weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in~     subjects with type 2 diabetes mellitus.~   "
107285|NCT01652716|"~     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once~     weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with~     type 2 diabetes mellitus.~      To examine the long-term (52 weeks of treatment) safety and effect on glucose control of~     exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.~   "
107286|NCT01652703|"~     The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every~     2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in~     low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in~     Japanese adults with hypercholesterolemia and high cardiovascular risk.~   "
107287|NCT01652690|"~     The objective of this prospective, observational study in Czech Republic and Slovakia is to~     describe per country the characteristics of women treated with denosumab in routine clinical~     practice and the clinical management of these patients during the first 2 years of~     treatment. In addition, the study aims to collect safety data in the real-life clinical~     practice settings on adverse drug reactions (ADRs) and serious ADRs.~   "
107288|NCT01652677|"~     The aim of research to study therapeutic possibilities of navigation transcranial magnetic~     stimulation in stroke rehabilitation, finding optimal protocol.~   "
107289|NCT01652664|"~     The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of~     Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution~     (0.5% or 0.25%) in pediatric glaucoma patients.~   "
107290|NCT01652651|"~     The purpose of this study is to report preliminary outcomes of executive function and~     psychopathology symptoms of a manual-based psychological intervention for adolescents~     diagnosed with learning disorders- I can succeed (ICS).~   "
107291|NCT01652638|"~     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic~     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by~     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP~     Pharmaceuticals, through the determination of activity of the following markers:~        -  Anti-FXa;~        -  Anti-FIIA.~   "
107292|NCT01652625|"~     Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative~     treatment available to date. The challenge remains in patients that do develop drug~     resistance and/or secondary infection, although topical corticosteroids and antimicrobials~     are the first therapeutic choice. The aim of the study was to evaluate the efficacy and~     safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative~     therapy for minor RAS.~      Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or~     capsule form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic~     function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally~     applied on RAS among Chinese population.~      In this study, a randomized, double-blind, placebo-controlled clinical trial (from March~     2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste~     containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene~     for 5 days. An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day~     3 and Day 5. Any noted adverse reactions were recorded.~   "
107293|NCT01652612|"~     Hypoxia frequently develops during one lung ventilation in the supine position.The objective~     of this article is to study the impact of preemptive alveolar recruitment and subsequent~     positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung~     ventilation in the supine position in patients undergoing thoracic surgery .~   "
107294|NCT01652599|"~     The purpose of this study is to determine the response rate and response duration with the~     combination of eltrombopag and high-dose dexamethasone~   "
107295|NCT01652586|"~     Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and~     analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are~     associated with respiratory depression and hypotension. The aim of this study was to compare~     the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect~     without serious respiratory depression, with conventional midazolam/remifentanil combination~     on sedative and analgesic levels in patients undergoing endocardial ablation.~   "
107465|NCT01650233|"~     This study assesses the impact of a mindfulness-based stress reduction program compared with~     a health education program for urban middle-school male youth on outcomes of psychological~     symptoms, coping, stress, sleep, and behavior.~   "
107298|NCT01652547|"~     This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity~     of pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell~     carcinoma. The study consists of three phases: screening, intra-patient dose-escalation, and~     follow-up phases.~      In the screening phase patient will be informed of all aspects of the study and sign~     informed consent forms and then be screened for study eligibility.~      During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide~     s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related~     clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose~     escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg~     for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose~     escalation phase for a maximum of 8 weeks.~      At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80~     mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6~     months or until disease progression, or unacceptable AEs, or patient withdraws consent. In~     addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that~     at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR~     follow-up phase, except on the day receiving the first LAR dose because of an anticipated~     initial burst of drug release.~   "
107299|NCT01652534|"~     The purpose of this study is to explore the efficacy of the drug Amantadine for the~     treatment of freezing of gait in patients with Parkinson's Disease. The investigators~     hypothesize that amantadine is useful for management of freezing of gait in subjects with~     Parkinson's Disease.~   "
107300|NCT01652521|"~     The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal~     balloon will allow us to measure and assess pleural pressure, and thus assess any possible~     effects of pleural fluid drainage may have on lung mechanics.~   "
107301|NCT01652508|"~     The purpose of this study is to evaluate the feasibility and potential efficacy of~     Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in~     primary healthcare settings.~   "
107302|NCT01652495|"~     The purpose of this study is to compare the efficacy and effects on the~     hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types~     of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder~     tendinopathy.~   "
107303|NCT01652482|"~     This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and~     efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil~     [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants~     with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed~     after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants~     will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab.~     Anticipated time on study treatment is until disease progression or unacceptable toxicity~     occurs.~   "
107304|NCT01652469|"~     Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are~     assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then~     randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel).~      It is hypothesized that the VeriStrat test results are able to predict the benefit of~     treatment with erlotinib vs docetaxel. This would suggest a significant improvement in~     progression-free survival for VSG patients when treated with Erlotinib, and no significant~     improvement in VSP patients who receive the same treatment.~   "
107305|NCT01652456|"~     This is a multicenter, interventional, randomized study for preventive and therapeutic~     strategies for patients with head and neck or Lung cancer; contribution of an addiction~     support~   "
107306|NCT01652443|"~     The current study will explore relationships and health in the OEF/OIF Veteran population.~     Specifically, this study will examine PTSD symptom severity, traumatic brain injury,~     relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and~     belongingness, and suicidal ideation.~   "
107307|NCT01652430|"~     This study plans to examine if symptoms of PTSD affect how Veterans who have served in~     combat think and react to certain information, and whether or not this has an influence on~     suicidal thoughts.~   "
107308|NCT01652417|"~     Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown.~     Despite this treatment, most patients will have chronic kidney disease. From our previous~     studies, the investigators believe that high dose steroids by methylprednisolone bolus will~     improve patient outcome and renal function.~   "
107309|NCT01652404|"~     The purpose of this study is to give conclusive evidence on whether serial PCT~     (Procalcitonin) measurements can facilitate individual decision-making and shorten~     antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care~     Unit).~   "
107310|NCT01652391|"~     Insufficient cognitive control over emotional distracters is characteristic for major~     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is~     associated with this deficit. In this study the investigators assess the effect of an~     enhancement of dlPFC activity in MDD patients by anodal transcranial direct current~     stimulation (tDCS) on cognitive control.~      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators~     determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD~     patients and healthy controls. To assess the cognitive control the investigators use a~     delayed response working memory (DWM) task with pictures of varying valence presented during~     the delay period.~   "
107311|NCT01652378|"~     In the proposed study, the investigators will assess the brain response to medication probes~     the investigators have previously studied with SPECT. The brain response to ondansetron and~     lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI~     (fcMRI).~   "
107324|NCT01652209|"~     Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who~     are the primary targets of the drug, long term efficacy in the improvement of the left~     ventricle ejection fraction upon the first cell treatment is to be evaluated and compared~     with the current existing treatments (contemporary drug treatment).This study will also~     compare the efficacy and safety of single dose of hearticellgram-AMI to a two dose regimen~     of hearticellgram-AMI.~   "
134872|NCT01289548|"~     The purpose of this study was to investigate whether lower limb ischaemic preconditioning~     can improve renal function in patients undergoing living donor kidney transplantation~   "
107312|NCT01652365|"~     The purpose of this study is to assess the feasibility and impact of introducing subsidized~     malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a~     randomized controlled trial at the village level, taking place in 6 districts in Eastern~     Uganda. Licensed drug shops in selected villages were trained in proper RDT storage,~     administration, interpretation and disposal and were given access to subsidized RDTs for~     sale. This study explores whether drug shop owners--when given access to training and~     subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what~     volume and what price. The investigators also explore whether shops will safely store,~     administer, interpret and dispose of RDTs and to what extent they will use RDT results to~     guide treatment recommendations. Finally, the study explores whether making RDTs available~     for sale in local drug shops has a community level impact on diagnostic testing and~     appropriate treatment for malaria.~   "
107313|NCT01652352|"~     Researchers from the University of South Florida's Rehabilitation Engineering program are~     looking for volunteers to participate in a research study for experimental evaluation of~     wheelchair-mounted robotic arms (WMRAs).~      Participants will operate commercially available and developmental WMRAs in a physical test~     environment. The study will serve to identify desirable design features of WMRAs and input~     devices so that future production systems may further increase the quality of life of~     potential users.~      The study will also promote both the justification of prescribing WMRAs to enhance quality~     of life through the proposed standard testing method, and awareness for the emerging~     assistive robotics industry.~   "
107314|NCT01652339|"~     To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male~     subjects~        -  PK parameter evaluation~        -  Safety profile evaluation~   "
107315|NCT01652326|"~     The overarching goal of this project is to improve the clinical quality of patients with~     Benzodiazepine-resistant alcohol withdrawal syndrome.~   "
107316|NCT01652313|"~     The purpose of this study is to fulfil regulatory requirements for registration of a new~     chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease~     (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and~     the efficacy and safety has been demonstrated in placebo- and active comparator-controlled~     phase III studies.~   "
107317|NCT01652300|"~     Periodontal diseased during pregnancy are associated with many unpleasant prenatal~     consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of~     such diseases and observance of oral and dental hygiene may to some large extent prevent~     such consequences. Unfortunately previous studies have shown that pregnant women have very~     little knowledge of oral and dental health implications. Given the fact that pregnancy my be~     a unique opportunity to initiate correct hygienic behaviors in young women, this paper has~     focused on studying the effects of oral and dental health education during pregnancy.~      In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi~     Regional Health Center in Mashhad city who were members of a community based multi-center~     were chosen by systematic clustering methods and randomly allocated into test and control~     groups. After intervention, two questionnaires were completed for demographic and pregnancy~     details of the participants. Knowledge, health belief and health behavior were assessed~     before intervention. The test group had two educational sessions lasting 1 hour, focused on~     oral and dental health and especially on oral and dental health during pregnancy. women in~     the control group received no education. Knowledge, health belief and health behavior were~     assessed immediately after and one month after intervention of all participants. Analysis of~     data was done using SPSS, t-test and chi-square tests.~   "
107318|NCT01652287|"~     The investigators believe a readily available drink containing a high dose of probiotics has~     the potential to improve compliance through many of these mechanisms. This product also has~     the potential to positively impact the health of children and adults around the world, as~     yogurt will likely be more appealing to both children and their parents for long term~     consumption than pharmaceutical-like preparations. In addition to the benefits associated~     with the consumption of probiotics, there is an increased health benefit from consuming~     yogurt, a nutrient dense food.~      More specifically, the rationale for this Phase I study is to determine safety of this~     yogurt drink and comply with FDA recommendations pertaining to an Investigational New Drug~     application. The investigators hypothesize that BB-12 is safe in generally healthy children~     ages 1-5 years.~   "
107319|NCT01652274|"~     It is well known that traffic accidents are one of the major reasons for death in childhood.~     Unfortunately scientific and statistical data usually comes from developed countries. In~     this study, the investigators will try to evaluate Turkish families' knowledge on Child~     Passenger Safety, observe how they carry their babies in the car and investigated the~     reasons behind the undesired behaviors.~   "
107320|NCT01652261|"~     The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and~     dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with~     treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine,~     procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG)~     positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has~     non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is~     to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.~   "
107321|NCT01652248|"~     Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker~     battery has run down, it is easily replaced by a short procedure. In those with heart muscle~     weakness, who use their pacemaker most of the time (rather than acting just as a back-up)~     the investigators want to find out if adding a further lead to their pacemaker system~     improves their heart's function, kidney function and exercise capacity.~   "
107322|NCT01652235|"~     The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is~     a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith®~     p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal~     aortic aneurysms.~   "
107323|NCT01652222|"~     The purpose of the study is to assess the efficacy of the systematic application of the~     CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's~     disease or other advanced stage dementia.~   "
135483|NCT01281540|"~     The purpose of this study is to assess the effectiveness of cisapride in patients with a~     primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.~   "
107325|NCT01652196|"~     This phase II trial studies how well giving aflibercept together with combination~     chemotherapy works in treating patients with previously untreated colon or rectal cancer~     that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may~     stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving aflibercept together with combination chemotherapy may kill more tumor~     cells~   "
107326|NCT01652183|"~     The insertion of an urinary catheter in a patient undergoing a surgical procedure,~     especially in urinary interventions, may lead to catheter-related bladder discomfort with~     varying degrees of severity during the postoperative period. Catheter-related bladder~     discomfort (CRBD) symptoms associated with indwelling urinary catheter are similar to~     overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency,~     frequency, burning sensation with or without urge incontinence. Paracetamol is a drug with~     proven efficiency for the management of mild and moderate postoperative pain. In this study,~     the investigators hypothesized to address the effect of single-dose intravenous paracetamol~     on postoperative CRBD following percutaneous nephrolithotomy surgery (PNL).~   "
107327|NCT01652170|"~     This study will consist of a brief interaction with the subject or parent or guardian to~     obtain consent, collect a blood sample, medical history, and physical examination of those~     who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well~     as processed into plasma in order to compute the APPY1 Test result, which is based on a~     combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from~     the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for~     those subjects that were discharged from the ED without an appendectomy or diagnosis of~     acute appendicitis. Use of the APPY1 Test to help identify low risk patients could~     significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure~     to ionizing radiation in children, adolescents, and young adults.~   "
107328|NCT01652157|"~     This is a long-term study in cystic fibrosis patients who are participating in the Cystic~     Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel~     disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be~     followed at their regular clinical care visits over a 10-year period and approached if they~     develop symptoms of fibrosing colonopathy for collection and use of further detailed~     information.~   "
107329|NCT01652144|"~     The purpose of this study is to find out what effects a new drug AT7519M has on mantle cell~     lymphoma.~   "
107330|NCT01652131|"~     There is no objective evidence of how long intravenous solutions remain inside venous blood~     vessels after they have been administered, therefore there is no definite guideline of how~     to administer them in the preoperative setting. Besides, obese patients represent a~     particular group of subjects as they theoretically with-hold a constant inflammatory~     response and that would modify the way solutions behave intravenously, that is how long they~     remain inside.~      Having said this, we wish to describe the way colloid solutions behave in this group of~     patients by taking serial blood samples in 12 obese patients after a colloid infusion, to~     calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time~     it remains intravascularly.~      All this in the hope this information will help, in the near future, to establish a more~     objective way to use these solutions and avoid possible complications due to~     over-administration.~   "
107331|NCT01652118|"~     The purpose of this study is to determine of clarithromycin effect on developing of~     bronchopulmonary dysplasia in preterm babies.~   "
107332|NCT01652105|"~     Randomized clinical trial of two preoperative diets before bariatric surgery (gastric~     bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected~     for a gastric bypass procedure~   "
107333|NCT01652092|"~     This is a standard of care treatment guideline for allogeneic hematopoetic stem cell~     transplant (HSCT) in patients with primary immune deficiencies.~   "
107334|NCT01652079|"~     This research study is a Phase II clinical trial. In addition to studying safety, Phase II~     clinical trials test if the investigational drug is effective and whether the drug works in~     treating a specific cancer. Investigational means that the drug is still being studied and~     that research doctors are trying to find out more about it-such as the safest dose to use,~     the side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet~     approved CRLX101 for your type of cancer.~      Camptothecin is a chemical extracted from plants that is the basis for the standard~     FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering~     with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of~     camptothecin and a large molecule (nanoparticle)that appears to allow more of the~     camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the~     tumor may increase the probability that the tumor cells will be damaged.~      CRLX101 has been well tolerated in the laboratory and in participants with different kinds~     of cancer.~      Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer.~     Bevacizumab has been successfully combined with many chemotherapy partners.~      It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique~     clinical activity in combination in the treatment of this disease due to the simultaneous~     inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically,~     it is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential~     to interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that~     this combination will work to treat your type of cancer.~   "
107335|NCT01652066|"~     the aim of the study is to get evidence for an enhancement of immune status in subjects~     after probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium~     longum SP 07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model -~     compared to placebo.~   "
107336|NCT01652053|"~     The primary endpoints of the investigation will include assessment of the maintenance of~     disc height demonstrated by radiographic evidence based on plain radiographs and MRI and~     relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is~     anticipated that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be~     comparable to or better than the historical published results for discectomy alone.~   "
107363|NCT01651559|"~     This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating~     symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left~     right comparison will be made, after using the study product and the placebo, for 8 weeks,~     twice daily, on each of the body sides (left right). In addition to the clinical~     evaluations, skin biochemistry will be studied using non-invasive techniques. The latter~     will be correlated with the clinical results of the patients. These will serve for future~     development of diagnostic assays and personalized therapies.~   "
107337|NCT01652040|"~     The goal of this proposal is to investigate the efficacy of a complimentary approach of~     evoked resistance training and testosterone replacement therapy on the changes in body~     composition and metabolic profile after SCI. The proposed method could become a recommended~     and simple intervention especially for individuals with limited access and poor tolerance to~     exercise. The rationale is based on the evidence that individuals with SCI experience~     decline in anabolic hormones which may be responsible for the deterioration in body~     composition and metabolic profiles and leads to increase obesity, type 2 diabetes mellitus,~     dyslipidemia and subsequently cardiovascular disease. The designed study will provide~     explanation to the adaptations in the energy source of the muscle cells in response to~     training.~   "
107338|NCT01652027|"~     Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII)~     and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people~     with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which~     interfere with the function of FVIII concentrates. The reason that some, but not all, people~     with severe hemophilia A develop inhibitors is incompletely understood. Understanding~     individual and environmental risk factors is important to be able to prevent and possibly~     treat inhibitors. This study will look at individual and treatment characteristics in babies~     with severe hemophilia A who have not yet received treatment with FVIII (called Previously~     Untreated Patients, or PUPS). Subjects in the study will be asked to provide diaries of~     treatments, medications, and illnesses. Treatment will be directed by the subjects'~     physician, but all subjects will receive Advate, a third-generation recombinant FVIII~     product. Subjects will have blood drawn for laboratory tests, which include studies of the~     immune system and genetic studies of the FVIII mutation, before and 7-9 days after the first~     treatment with FVIII, and 5 days (+/-2 days) after the 5th, 10th, 20th, 30th, 40th, and 50th~     days of treatment with FVIII (exposure days). The duration of the study will be first 50~     treatments or 3 years, whichever comes first.~   "
107339|NCT01652014|"~     This study will determine the safety and applicability of experimental forms of umbilical~     cord blood (UCB) transplantation for patients with high risk hematologic malignancies who~     might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a~     standard donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated~     donor (MUD)), or single UCB unit with adequate cell number and HLA-match).~   "
107340|NCT01652001|"~     The aim of our study was to evaluate the clinical efficacy of a topical sialogogue spray~     containing 1% malic acid on patients affected by xerostomia caused by drugs.~      This research took the form of a double-blind, randomized clinical trial at Faculty of~     Dentistry of University of Granada (Spain). Participants with antidepressant-induced and~     antihypertensive-induce xerostomia were divided into two groups: for the first 'intervention~     group' a topical sialogogue spray (1% malic acid) was applied, while for the second 'control~     group', a placebo spray was applied; for both groups the sprays were applied on demand~     during two weeks. The Dry Mouth Questionnaire (DMQ) was used to evaluate xerostomia levels~     before and after product/placebo application. Unstimulated and stimulated salivary flows~     rates, before and after application, were measured.~   "
107341|NCT01651988|"~     OBJECTIVE: To determine the efficacy of ketamine-propofol anesthesia in a mixture 1:2 (1 mg~     of ketamine per 2 mg of propofol) for short minimally invasive surgical procedures.~      METHODS: The investigators performed a prospective study through randomization of 77~     patients undergoing short surgical procedures in two study groups: one received a mixture of~     ketamine-propofol in a 1:1 ratio, and the other received a 1:2 mixture. Data were stored in~     an Excel spreadsheet and analyzed using the statistical program Epi-Info (TM) 3.5.3. The~     investigators performed the comparison of qualitative and quantitative variables.~      KEY WORDS: ketamine, propofol, anesthesia.~   "
107342|NCT01651975|"~     Dysphagia is extremely common. The importance of providing adequate nutritional support to~     persons with dysphagia is the cornerstone to exceptional care. Diet modification with~     thickening agents is an essential aspect of this nutritional support. The purpose of this~     investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based~     thickening agent (Thickenup Advance or TUA).~   "
107343|NCT01651962|"~     Labor pain is a major factor in making the placement of an epidural catheter difficult. The~     epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve~     this goal as fast and safely as possible it would be helpful to have a parturient who can~     tolerate and co-operate with the placement of the epidural catheter.~      Briefly stopping contractions, the cause of labor pain, could be the key to achieve this~     goal.~      This study will evaluate the safety, efficacy and duration of the drug terbutaline for this~     purpose.~   "
107344|NCT01651949|"~     This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent~     HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV~     efficacy findings in young women to young men based on the demonstration of similar~     immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody~     responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody~     responses in young women.~   "
107345|NCT01651936|"~     The purpose of this study is to assess the safety and efficacy of MK-8457 in participants~     with active rheumatoid arthritis (RA) and an inadequate response or intolerance to~     anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of this study is~     that among participants with active RA, MK-8457 100 mg twice daily (BID) will be superior to~     placebo as measured by the change in Disease Activity Score 28 C-Reactive Protein~     (DAS28-CRP) after 12 weeks of treatment.~   "
107346|NCT01651923|"~     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic~     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by~     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP~     Pharmaceuticals, through the determination of activity of the following markers:~        -  Anti-FXa;~        -  Anti-FIIA.~   "
107466|NCT01650220|"~     This is an observational study designed to determine whether veterans with PTSD have a~     higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed~     by interview and review of medical records, carotid artery ultrasound, and blood tests~     measuring markers of inflammation. Study participation is approximately 6 months. The~     eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation~     Enduring Freedom (OEF), age 28 through 38 years.~   "
107347|NCT01651910|"~     The aim of the following study is to identify if cancer patients in pain report unmet~     supportive care needs that are comparable to the general cancer population or if these unmet~     needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the~     patients have intermittent breakthrough pain. 312 cancer patients, who have reported to have~     either controlled, uncontrolled or breakthrough pain, will complete a series of~     questionnaires at two time points. The primary outcome is to determine the prevalence of~     self-perceived unmet supportive care needs, as identified by the Supportive Care Needs~     Survey -Short Form (SCNS-SF), in people who have pain caused by their cancer or cancer~     treatment.~      Hypothesis- Patients with pain caused by their cancer or cancer treatments will report unmet~     needs, which will increase if their pain is uncontrolled or if they have breakthrough pain.~      Secondary Objectives-~        1. To establish if other confounding factors -such as age, gender, marital status,~          diagnosis, educational level and treatment, are significant predictors in the reporting~          of unmet needs of people with cancer or cancer treatment related pain.~        2. To establish if there are any other symptoms, identified by the Memorial Symptom~          Assessment Scale - Short Form (MSAS-SF), that are significant predictors in the~          reporting of unmet needs of people with cancer or cancer treatment related pain.~        3. To compare the prevalence and severity of self-perceived unmet supportive care needs~          between people who experience controlled pain, uncontrolled pain and breakthrough pain.~        4. To compare the prevalence and severity of unmet supportive care needs of people whose~          pain has become controlled or uncontrolled over a period of four weeks.~        5. To identify if there are any changes in the participants' symptoms, Eastern Cooperative~          Oncology Group (ECOG) performance score or treatment that could contribute to a change~          in the reporting unmet needs between time point one and two.~        6. To establish if there are any characteristics of breakthrough pain, such as the~          frequency or severity of pain episodes, that have an association with prevalence and~          the severity of the unmet supportive care needs reported by patients with breakthrough~          pain caused by their cancer or cancer related treatments. Factors will be identified by~          the Breakthrough pain Assessment Tool (BAT).~   "
107348|NCT01651897|"~     Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly~     understood. To date, the predominance of delirium studies have been conducted in~     hospitalized patients and therefore have limited generalizability to the ED. Understanding~     ED delirium's natural course and its effect on outcomes is not well characterized. The~     investigators hypothesize that a significant proportion of patients who are delirious in the~     ED will remain delirious in the hospital, and persistent cases of ED delirium will be~     significantly associated with higher 6-month mortality and accelerated functional decline.~     To test this hypothesis, the investigators will perform a prospective cohort study that will~     enroll 150 older ED patients with delirium and a random selection of 150 older ED patients~     without delirium; both groups will comprise of admitted ED patients only. Once enrolled in~     the ED, the investigators will assess patients for 7 days during hospitalization and perform~     phone follow-up at 6-months.~   "
107349|NCT01651884|"~     The purpose of this study is to assess the changes in language processing of patients with~     chronic aphasia after receiving non-invasive brain stimulation.Previous research using~     traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has~     shown that persons with aphasia show more improvement after treatment when that treatment is~     accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver~     current to more specific locations in the brain. This new delivery method is called~     high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse~     current delivery) or HD-tDCS (more focal current delivery) will be the better approach for~     enhancing treatment outcomes. To answer this question, computerized speech-language~     treatment will be administered during the application of the different forms of brain~     stimulation.~   "
107350|NCT01651871|"~     The primary objective of the study was to examine the efficacy and safety of~     S-555739/cetirizine HCl compared with the individual components and placebo.~   "
107351|NCT01651858|"~     The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy~     male volunteers.~   "
107352|NCT01651845|"~     The investigators have recently developed an innovative optical molecular imaging platform~     (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a~     hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact~     means of obtaining instantaneous image-based measurements of diagnostically-relevant~     biological and molecular information of a wound and surrounding skin tissues for the first~     time and could have significant impact on improving conventional wound care, management, and~     guidance of intervention. In preliminary preclinical testing, the investigators have~     discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the~     connective tissue matrix emit a characteristic green fluorescent signal, while most~     pathogenic bacterial species emit a unique red fluorescence signal due to the production of~     endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast~     agents are needed during imaging, making this approach particularly appealing as a~     diagnostic imaging method for clinical use.~      Based on extensive preclinical studies in our labs, PRODIGI has demonstrated its capability~     at collecting autofluorescence images of wounds and detecting the presence and relative~     changes in connective tissue (e.g. collagen) content and bio-distribution involved in wound~     healing. It can also detect the presence and relative amounts of commensal and pathogenic~     bacteria within the wound based on autofluorescence alone (these bacteria are invisible to~     standard visualization with the naked eye using white light), thus providing a measure of~     infection status. This could significantly impact clinical wound care and management by i)~     reducing the complications associated with missed detection of bacterial infection under~     conventional practice, ii) facilitating image-guided wound sampling by targeted~     swabbing/biopsy and iii) monitoring wound healing and treatment response over time.~      Previous Related Studies: A pilot-level clinical study (UHN REB protocol # 09-0015-A, PI:~     DaCosta, 50 patients imaged to date) performed by our group from 2008-2011 to assess the~     clinical utility of the device successfully demonstrated that tissue autofluorescence~     produced by endogenous collagen/elastin in the skin appears green in the fluorescent images,~     while most clinically-relevant bacterial colonies present in the wound produce a red~     fluorescence signal caused by endogenous porphyrins. Some bacterial species (e.g.~     pseudomonas aeruginosa) produce a green fluorescence signal that can be differentiated~     spectrally and texturally from the fluorescence of the dermis (another hue of green,~     discernable by our proprietary image analysis software). The PRODIGI device is sensitive~     enough to detect these green and red fluorescence signals from tissue and bacteria~     confirming the utility of this compact and portable imaging platform for clinical wound~     care.~      The investigators hypothesize that real-time imaging of tissue autofluorescence signals~     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within~     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound~     closure), detect wound bacterial contamination and/or infection that is occult under~     standard clinical white light evaluation, and guide intervention during wound care.~   "
107353|NCT01651832|"~     Aim of the study is to increase the proportion of indicated patients with colorectal cancer~     undergoing adjuvant chemotherapy following surgical resection through an optimized symptom~     management and logistical support.~   "
107354|NCT01651819|"~     Urological physical therapy is described to improve urinary symptoms in patients with~     myelopathy or neurological dysfunction and to increase the quality of life. Although it was~     never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is~     common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is~     that urological physical therapy can improve urinary symptoms like incontinence, urgency and~     nocturia in HTLV-1 infected population with those complains.~   "
107355|NCT01651663|"~     The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the~     treatment and Prophylaxis of Influenza and Common Cold~   "
107356|NCT01651650|"~     Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile~     through the NEXThaler® device in adult asthmatic patients with varying degrees of disease~     control.~   "
107357|NCT01651637|"~     The aim of this study is to investigate the safety and tolerability of intratracheal~     administration of two different single doses of CHF 5633 in preterm neonates with RDS in~     terms of adverse events, adverse drug reactions, hematology and biochemistry values, the~     incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and~     mortality.~   "
107358|NCT01651624|"~     RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting~     colorectal neoplasms and may be a primary test in colorectal cancer screening.~      PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of~     computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a~     primary screening test in a population-based programme.~   "
107359|NCT01651611|"~     The purpose of this study is to determine whether public housing residents trained in~     Tobacco Cessation and Motivational Interviewing Techniques to become Tobacco Treatment~     Advocates(TTA) will be effective in increasing the quit rate of smokers in Boston Public~     Housing. The investigators hypothesize that smokers that receive multiple TTA visits will be~     more likely to (1) use smoking cessation resources and (2) quit compared to smokers who~     receive a single visit.~   "
107360|NCT01651598|"~     In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of~     multiple dose administration of BI 144807 will be investigated in otherwise healthy,~     controlled asthmatic patients~   "
107361|NCT01651585|"~     The infection with cytomegalovirus (CMV) is the first cause of congenital neurological~     handicap of infectious origin. It is probable that the néonatale viral load is correlated~     with becoming of infected new-born babies. Among the active antiviral treatments against~     CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the~     pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to~     evaluate it in a study. Decrease the fœtal viral load could make possible to decrease~     symptomatology néonatale in a group of infected fœtuses.~   "
107362|NCT01651572|"~     The purpose of this study is to determine the incidence of post-operative residual~     curarization in our patients and to determine if Cisatracurium and Rocuronium behave~     differently from each other in terms of residual curarization.~   "
107364|NCT01651546|"~     The aim of the study is to create and validate a specific test named Intermittent~     Catheterization Acceptance Test (I-CAT), assessing the acceptance of clean intermittent~     self catheterization (CISC) in a neurological and no neurological population with indication~     to self catheterization.~      CISC avoids urological complications in bladder with chronic and improves quality of life.~     Despite theses challenges, the learning of CISC can face some physical, cognitive and~     psychological difficulties. Recently, we have validate a new test for predicting the~     physical and cognitive abilities to practice CISC named PP-Test. Meanwhile, psychological~     factors are not explored in this test. To our knowledge, no study has been conducted in~     order to demonstrate in a prospective trial, which kind of psychological barriers can exist.~     Likewise it would be interesting to create a new test assessing the psychological~     acceptance of the patients to CISC before learning (I-CAT). Based on the results of this~     self-assessment test, the specific nurse could then change her speech by playing down the~     importance of some fear and anxiety described by the patients. The learning of CISC would be~     facilitated.~   "
107365|NCT01651533|"~     Stroke is the leading cause of disability in the United States, producing motor impairments~     that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is~     particularly disabling, is the primary impairment underlying stroke-related disability, and~     the most frequent impairment treated by therapists in the United States. This study will~     test efficacy of a promising technique in reducing arm disability and increasing function,~     thereby improving outcomes and health, reducing care costs, for community dwelling patients~     with stroke-induced hemiparesis.~   "
107366|NCT01651520|"~     In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify~     neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an~     early stage. The investigators will follow up patients to determine the prognostic value of~     this neuronal injury.~   "
107367|NCT01651507|"~     this is a multicenter retrospective study on patients with pulmonary LCH who were~     sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of~     this study were: 1) to determine the changes over time of lung function parameters in~     patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results~     during follow-up; 3) to address the respective interest of these investigations for~     identifying the patients who eventually will experience a progression of their disease.~   "
107368|NCT01651494|"~     This study will be a double-blind, randomized, placebo-controlled study of a single dose~     (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be~     randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the~     inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in~     the inpatient clinic for the duration of dosing and one day after dosing, they will be~     required to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3~     days), and 90 (+/-10 days). The safety parameters will include abnormal laboratory values,~     adverse events and clinical observations.~   "
107369|NCT01651481|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10~     mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102~   "
107370|NCT01651468|"~     Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to~     assist in wound healing and bleeding arrest. It contains herbs such as Red Clover,~     Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the~     coagulation system.~   "
107371|NCT01651455|"~     The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in~     2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.~   "
107372|NCT01651442|"~     Chronic insomnia is a prevalent disorder associated with increased health care costs,~     impaired functioning, and an increased risk for developing serious psychiatric disorders.~     Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications~     are the most widely supported approaches for insomnia management. Unfortunately, few studies~     have compared the psychological/behavioral therapies and BzRAs for insomnia treatment.~     Moreover, insomnia treatment studies have been limited by small, highly screened study~     samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual~     adjustable dosing practices, relatively short follow-up intervals, and reliance on~     self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more~     clinically relevant indicators of remission. Finally, studies have yet to test the benefits~     of treatment sequencing for those who do not respond to initial their insomnia therapy. This~     multi-site project will address these limitations. Two study sites will enroll a total of~     224 participants who meet broad criteria for a chronic insomnia disorder, and a sizeable~     portion (60%) of this sample will have insomnia occurring comorbid to a psychiatric~     disorder. Participants will be evaluated with clinical assessments and PSG, and then will be~     randomly assigned to first-stage therapy with an easy-to-administer behavioral insomnia~     therapy (BT) or zolpidem (most widely prescribed BzRA). Centrally trained therapists will~     administer therapies according to manualized, albeit flexible, treatment algorithms. Initial~     outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the~     next 12 months on maintenance therapy. Those not achieving remission will be offered~     re-randomization to a second, 6-week treatment involving pharmacotherapy (zolpidem or~     trazodone) or psychological therapy (BT or cognitive therapy-CT). All participants will be~     re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups~     while continuing their final treatment. Insomnia remission, defined categorically as a score~     < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment~     comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective~     ratings of sleep and daytime function; adverse events; dropout rates; and treatment~     acceptability. Our over-arching goal is to obtain new information that aids in the~     development of clinical guidelines for managing insomnia sufferers with and without comorbid~     psychiatric conditions.~   "
107373|NCT01651429|"~     Resilience is the ability to cope effectively and adapt to a wide range of stressful~     environmental challenges. Sleep loss has been shown to reduce activity in the brain regions~     responsible for resilience. The ability to resist the effects of sleep loss appears to be a~     stable, trait-like quality. This study will attempt to predict individuals' trait-resistance~     to sleep loss based on their neurobiology.~   "
107389|NCT01651221|"~     Increasing exposure to a single orosensory cue without ingestion of additional energy may~     promote an increased rate of habituation, more rapid satiation, and reduced intake. This~     exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if~     repeated exposure via the combined olfactory and gustatory systems increases the rate of~     habituation more so than repeated exposure through one of these systems. Thus, the purpose~     of this investigation is to examine the amount of salivation occurring in 12 trials of~     exposure to a food via the olfactory, gustatory, and combined olfactory and gustatory~     systems. The primary dependent variable will be the amount of salivation in the 12 trials.~     It is hypothesized that a more rapid decrease in salivation will occur across trials in the~     combined olfactory and gustatory exposure as compared to the other two conditions,~     indicating a more rapid rate of habituation.~   "
107374|NCT01651416|"~     In areas of Africa where malaria is only a problem during a short rainy season, monthly~     courses of antimalarial drugs can provide very effective prevention of malaria in children.~     This approach, called intermittent preventive treatment in children (IPTc) but now known as~     Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where~     malaria is transmitted for longer each year. It is uncertain if IPTc would be effective,~     acceptable to communities or sustainable when delivered over a longer period, but this is an~     important public health question of key interest to policy makers, because in areas with a~     longer transmission season, the burden of malaria is typically higher than in highly~     seasonal areas.~      Another form of prevention that would be operationally easier for African countries to put~     into practice would be to treat malaria patients with long-lasting antimalarials, which~     protect children against further malaria episodes for several weeks. Because malaria~     disproportionately affects certain high risk children more than others, causing repeated~     attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and~     effective way to target limited resources at the individuals who most need protection. This~     may be particularly beneficial where malaria is a seasonal problem, because repeated malaria~     attacks will not only be borne by a few unfortunate children, but will also occur close~     together in time.~      The investigators propose a clinical trial to evaluate these two forms of chemoprevention in~     Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years~     of age currently have access to diagnosis and treatment of malaria via by community based~     health workers. Children enrolled in the study will receive either the standard~     community-based diagnosis and treatment, treatment with a longer-acting artemisinin~     combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria~     chemoprevention (SMC) during the peak in transmission.~   "
107375|NCT01651403|"~     This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir~     disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B~     infection. While studies have shown significant virologic response in adults and~     adolescents, the effect in children is not well established. This study will provide~     valuable data that can help establish the efficacy and safety profiles of TDF in children.~     The study will consist of 48 weeks of blinded randomized treatment, after which participants~     will switch to open-label TDF treatment for an additional 144 weeks.~   "
107376|NCT01651390|"~     To determine in a randomized controlled trial (RCT) whether percutaneous coronary~     intervention - in patients with in-stent restenosis in either bare metal stents or drug~     eluting stents - with the Pantera Lux balloon is angiographically non-inferior to~     percutaneous intervention with the Orsiro stent 6 months post-procedure.~   "
107377|NCT01651377|"~     The purposes of this study are as follows: 1. To assess the cardiovascular and subjective~     effects of cocaine during treatment with pramipexole and placebo. 2. To assess the~     reinforcing effects of cocaine, measured using choice procedures, during treatment with~     pramipexole and placebo.~   "
107378|NCT01651364|"~     The purpose of this study is to determine the effects of treatment with cabergoline,~     compared to treatment with placebo, on cocaine induced craving and subjective effects in~     cocaine-dependent human volunteers.~   "
107379|NCT01651351|"~     The purpose of this study was to generate sufficient safety and tolerability information in~     support of an increase in the infusion rate of intravenous GLASSIA in the prescribing~     information from 0.04 to 0.2 mL/kg/min.~   "
107380|NCT01651338|"~     Chronic pains can affect the life quality. This study has performed in the first time in~     Mashhad.The purpose of the present study was to examine the effect of acupuncture on the~     life quality of 150 patients who suffered from chronic pain. Some people like performing~     acupuncture because they believed it's free of risks and beneficial.~      In order to achieve this purpose, we had examined the life quality of the patients before~     and after acupuncture. This study was randomly performed on 150 patients aged between 17-75.~     They were suffering from chronic pain.~      The questionnaire is based on WHO QOL. The questionnaires were filled out once before~     acupuncture and once 12 weeks after it.~   "
107381|NCT01651325|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.~   "
107382|NCT01651312|"~     The study aims to assess the routes and the extent of metabolism and excretion of YM178~     after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy~     male volunteers.~   "
107383|NCT01651299|"~     The primary objective of the study is to evaluate the responsiveness and utility of several~     clinical outcome assessments in the setting of copperhead snakebite. The secondary objective~     is to characterize the clinical course of signs, symptoms and impairment during the recovery~     phase of copperhead snakebite.~   "
107384|NCT01651286|"~     Recently, the investigators demonstrated that nasal route ventilation is superior to the~     nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The~     investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask~     ventilation during the induction of general anesthesia by: 1) producing a better seal than~     full face mask, and 2)establishing a greater airway patency and more effectively ventilate~     than full face mask ventilation. The investigators intend to test this hypothesis on adult~     patients during the induction of general anesthesia in the absence of muscle relaxation.~   "
107385|NCT01651273|"~     The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in~     patients with high cholesterol.~   "
107386|NCT01651260|"~     Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the~     nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may~     result in accidental slippage of the tube into a mainstream bronchus or into the pharynx.~     Hollister Incorporated is assessing the functionality and performance of an endotracheal~     tube securement device.~   "
107387|NCT01651247|"~     This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK~     Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B~     (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria~     and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)~     vaccine products. The samples have been collected at pre-determined time points from a~     subset of subjects who participated in selected studies [217744/085 and 213503/048]~     conducted in the United States.~   "
107388|NCT01651234|"~     The purpose of this study is to evaluate the safety, tolerability and characterize the PK,~     PD f\profile.~   "
107390|NCT01651208|"~     The purpose of this study is to evaluate if the use of a phone based motivational~     interviewing among minority populations who received a coronary stent can improve adherence~     to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12~     months post stent placement when compared to a mailed educational DVD.~   "
107391|NCT01651195|"~     The purpose of this study is to evaluate the effect of regular consumption of probiotic~     tablets in preventing illnesses in Finnish healthy adults attending military service.~   "
107392|NCT01651182|"~     Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss~     and blood transfusion requirements in the following patient populations: multisystem trauma,~     liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver~     resection are at risk of severe perioperative blood loss and may also benefit from~     perioperative TXA administration.~      This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic~     properties of two well studied dosing regimens of TXA will provide guidance in determining~     the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling~     evidence of the effectiveness of TXA comes from the large multicentred, multi-national~     CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In~     liver transplant surgery, the following dose regimen has been shown to have great effect:10~     mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.~      Although TXA is not currently approved for use in patients undergoing major liver resection,~     Health Canada has allowed the use of tranexamic acid for use in this research study.~   "
107393|NCT01651169|"~     Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols~     have shown that a conditioning TMS pulse applied to the human motor cortex changes the~     excitability of motor pathways from the motor cortex to spinal motorneurons. These effects~     depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A~     characteristical sequence of inhibition (short interval cortical inhibition [SICI],~     GABA-Aerg), facilitation (intracortical facilitation [ICF]), and inhibition again (long~     interval cortical inhibition [LICI], GABA-Berg) is thought to be physiologically involved in~     motor control. Previous studies have also shown that neuronal inhibitory motor circuits are~     also disturbed in ADHD which will be restored by using methylphenidate. In this study the~     investigators sought to investigate if methamphetamine abuse (from the same chemical class~     of medications) will alter such effects of methylphenidate.~   "
107394|NCT01651156|"~     A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the~     efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid~     retention caused by congestive heart failure) based on the conventional therapy.~      To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients~     with body fluid retention after current diuretic treatment, after continuous treatment of 7~     days' oral Tolvaptan 15mg or placebo.~   "
107395|NCT01651143|"~     Primary Objective:~      - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients~     with diffuse cutaneous systemic sclerosis.~      Secondary Objectives:~        -  To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis~          as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor~          signaling markers in blood and skin;~        -  To explore the effect of SAR100842 on skin thickness in patients with systemic~          sclerosis as measured by the modified Rodnan Skin Score (mRSS);~        -  To explore the effect of SAR100842 on quality of life as measured by the Scleroderma~          Modified Health Assessment Questionnaire (SHAQ);~        -  To document long term safety of SAR100842 during the extension part.~   "
107396|NCT01651130|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most common uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which~     requires a continuous infusion to achieve sustained uterotonic activity. The Society of~     Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg~     dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent~     post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin~     lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent~     greater efficacy rate. However, a dose response study to determine the minimum effective~     dose of carbetocin has not yet been published. The investigators hypothesize that the~     minimum effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing~     elective Cesarean delivery.~   "
107397|NCT01651117|"~     The purpose of this study is to test the effectiveness of a peer mentor model in a mixed~     race population of poorly controlled diabetic Veterans. Also, the study aims to assess the~     effects of becoming a mentor on those who originally were mentees. It is expected that~     participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control~     regardless of race or ethnicity at the end of the intervention.~   "
107398|NCT01651104|"~     To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted~     influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody~     response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and~     hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly~     subjects in compliance with the requirements of the current EU recommendations for clinical~     trials related to yearly licensing of influenza vaccines.~   "
107399|NCT01651091|"~     The purpose of this study is to investigate the effects of an eight-week long group-based~     secular intervention known as Meditation Awareness Training (MAT) on psychosocial~     functioning in prison participants.~   "
107400|NCT01651078|"~     The need for new technologies and devices in the field of neurosurgery is well established.~     In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser~     thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to~     abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study~     will include patients with metastatic tumors who failed stereotactic radiosurgery and are~     already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality~     of Life (QoL) and, where feasible, healthcare utilization data for publication.~   "
107401|NCT01651065|"~     The purpose of this randomized trial is to study the efficacy of a novel social propagation~     intervention which integrates social network induction with health education for weight and~     metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular~     disease. The intervention takes place in the form of a community health program, where~     participants who enroll in this program will be asked if they would like to take part in the~     study to evaluate its efficacy. Thus, the investigators will study the efficacy of social~     networks in propagating changes in lifestyle factors for diabetes and chronic disease~     management~   "
136976|NCT01262105|"~     The objective of this study is to determine whether the Air Barrier System device reduces~     airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal~     procedures.~   "
107403|NCT01651039|"~     The purpose of this clinical research study is to find out the effects of a drug called~     panobinostat (LBH589) when given to people like you with multiple myeloma in combination~     with the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will~     also be studied. Your physical state, changes in the state of your multiple myeloma, and~     laboratory findings taken while on-study will help us decide if panobinostat combined with~     dexamethasone and lenalidomide is safe and effective.~      This goal of this study therefore is to determine the activity of the combination of~     panobinostat thrice weekly every other week, lenalidomide, and weekly dexamethasone in a~     similar group of subjects. The doses of lenalidomide and dexamethasone will be that which is~     approved by the FDA for multiple myeloma and you will take each drug at a specific frequency~     over a 4 week (28 day) period. This period is called a study cycle.~   "
107404|NCT01651026|"~     The purpose of this study is to describe the diagnostic and treatment procedures employed~     for patients with rectal cancer in each participating center. Outcomes to treatment, costs~     of treatment will be described. Exploratory analyses will be done to identify factor that~     influence patient prognosis, as well as factors that predict patient response to treatment.~   "
107405|NCT01651013|"~     The purpose of this study is to describe the treatments received and outcomes of patients~     with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of~     the tumor, and to describe the costs of treatments. Information will also be collected~     regarding risk factors, variables among treatment centers and patients, and explorative~     analyses will be done to try to identify factors that impact prognosis and factors that~     predict tolerability and response to treatment.~   "
107406|NCT01651000|"~     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact~     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and~     tolerability of CTAP101 will also be evaluated~   "
107407|NCT01650987|"~     Evaluate the toxicities of cervix and corpus uteri carcinomas treatment~   "
107408|NCT01650974|"~     The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen~     therapy during diagnostic bronchoscopy.~   "
107409|NCT01650961|"~     The purpose of this study is to assess the effects of palonosetron on corrected QT interval~     duration during and after general anesthesia.~   "
107410|NCT01650948|"~     Patients with AMD will provide cheek cell samples to determine if their is a correlation~     between genotype (DNA markers) and phenotype (the type of AMD the patient has).~   "
107411|NCT01650935|"~     Oxalate restricted diet is routinely prescribed in clinical practice of nephrolithiasis~     patients with hyperoxaluria. The effect of dietary oxalate on urinary oxalate is however~     controversial. Some studies do not implicate dietary oxalate as a major risk factor for~     nephrolithiasis. The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in~     fruits and vegetables, moderate in low-fat dairy products, and low in animal protein~     represents a novel potential means of kidney stone prevention. The effect of a DASH-style~     diet on relative urinary supersaturations is however uncertain. Higher consumption of fruits~     and vegetables may increase urinary oxalate but also increases urinary citrate, an important~     inhibitor of calcium saturation.All the above data lead us to hypothesize that a DASH diet~     other than an oxalate restricted diet, which is routinely administered in clinical practice,~     might be beneficial in lowering urinary relative supersaturations of calcium oxalate in~     recurrent stone formers with hyperoxaluria.~      Recurrent stone formers with hyperoxaluria (urine oxalate>32.8) are allocated into 2 groups.~     The first group is prescribed an oxalate restricted diet. The second group are asked to~     follow a calorie-controlled DASH diet plan while drink water in the same amounts. 24-h urine~     is collected 2 times before study visits at baseline, 1 time on week 6 and 2 times at the~     end of the study.~   "
107412|NCT01650922|"~     To look for patterns of polymorphisms in DNA repair in both germline and tumor cells~     samples.~   "
107413|NCT01650909|"~     This study is an independent sub-study of the protocol titled PKU-016: A double-blind,~     placebo-controlled, randomized study to evaluate the safety and therapeutic effects of~     sapropterin dihydrochloride on neuro-psychiatric symptoms in subjects with phenylketonuria~     (PKU ASCEND).~      The primary objective of this study is to determine oxidative stress in patients with~     classical phenylketonuria (PKU) enrolled in PKU-016, using a brain scan (called an HMPAO~     SPECT) at baseline and 26 weeks, and blood redox biomarkers.~   "
107414|NCT01650896|"~     The typical delirium study between 1989 and 2005 compared delirium management in a specialty~     unit such as geriatric medicine with delirium management in general medicine (in most cases~     the research diagnosis of delirium was not communicated to the general medicine group). This~     study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and~     general medicine groups (medical staff, patients, families) plus daily monitoring of~     delirium using digit span and delirium index which is reported to both patient groups. It~     will also compare confusion assessment method (CAM)to a novel diagnostic system of Paul~     Regal with respect to hard endpoints (survival and return home). Hypotheses: 1) General~     medicine can manage delirium as well as geriatric medicine when delirium is openly diagnosed~     and monitored daily (even in speciality units it is rare to find daily measurement of tools~     such as delirium index); 2) The Regal diagnostic system will be superior to the CAM in~     predicting hard endpoints (survival and return home rate for patients living in the~     community).~   "
107415|NCT01650883|"~     The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol)~     oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels.~     While these two regimens in the end provide equal total dosing, the two arms differ in~     frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct~     comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a~     paired T-test. Secondary endpoints include record of adverse events throughout the 40 day~     study period as well as changes in basic laboratory values including CMP and ionized~     Calcium.~      The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000~     IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given~     every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of > 50 mg/dL at~     day 40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve~     this level and that 35% of the subjects in the every 10 days dosing arm will reach this~     goal.~   "
107418|NCT01650844|"~     This project aims to improve guideline-based asthma care using enhanced communication and~     screening tools, telemedicine and directly observed therapy of preventive medications in~     city schools. Web-based screening will be used to identify children with persistent or~     poorly controlled asthma and to send reports to the child's primary care doctor. Children in~     the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed~     a daily preventive asthma medication to be taken through school-based directly observed~     therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention~     for improving guideline based care, enhancing adherence to effective preventive medications~     and at reducing morbidity among young urban children with asthma.~   "
107419|NCT01650831|"~     The purpose of this study is to confirm equivalence of a new generation breath analyzer~     (Modified BreathID) in its ability to detect H. pylori compared to the currently approved~     BreathID® System.~   "
107420|NCT01650818|"~     The purpose of this study is to compare the safety and the effects of moderate-intensity~     aerobic endurance training to those of an usual physical therapy intervention on exercise~     capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).~   "
107421|NCT01650805|"~     The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients~     with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.~   "
107422|NCT01650792|"~     The main purpose of the study is to determine noninvasive markers of brain involvement in~     Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on~     transcranial Doppler monitorization, the investigators aim to determine the efficacy and~     safety of aspirin in preventing microembolization in patients with no previous history of~     stroke. Specific aims are listed bellow:~      (1) to establish brain magnetic resonance imaging markers of stroke risk in patients with~     Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in~     patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in~     decreasing microembolization rate in patients with Chagasic HF.~   "
107423|NCT01650779|"~     This is an exploratory study to evaluate changes in glycosphingolipid levels and other~     (exploratory) Fabry disease parameters in male Fabry disease participants who were~     previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every~     two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.~   "
107424|NCT01650766|"~     The primary purpose of the study is to investigate the correlation between the efficacy and~     toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS),~     dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).~   "
107425|NCT01650753|"~     Healthy adults referred to as the absence of intestinal disorders, liver and kidney~     problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be~     recruited. This research study will test the persistence of the probiotic (healthy~     bacterial) strain Bifidobacterium longum spp. longum in the human gastrointestinal tract~     after it is consumed, how it is tolerated, and its interactions with other micro-organisms~     already present in your gastrointestinal tract. The strain used is similar to bacteria used~     in probiotic yogurts, and the species Bifidobacterium is generally regarded as safe. The~     patient will be asked to will be consume a probiotic powder containing Bifidobacterium~     longum spp. longum strain AH1206 and a placebo in a random order, with neither the patient~     nor the investigators knowing the identity of the preparations given. Persistence or~     presence of the probiotic strain will be based on analysis of fecal (stool or bowel~     movement) samples provided.~   "
107426|NCT01650740|"~     In recent years, there has been growing evidence that antidepressants are only marginally~     effective compared to placebo for mild to moderate depression. In other words, although many~     people improve when they take antidepressant medications, almost as many get better with~     placebo pills. One possible solution to this problem would be to give patients a trail of a~     placebo prior to giving them an antidepressant, however there are ethical issues with doing~     this deceptively. New evidence from other placebo-responsive disorders such as irritable~     bowel syndrome shows that people may benefit from placebos even if they know they are taking~     them. This study aims to determine whether giving placebos without deception to people with~     major depressive disorder followed by the option to switch to an antidepressant is an~     effective strategy. There will be 3 groups of subjects. The first group is a standard~     treatment arm and will receive duloxetine, an antidepressant. The second will be given a~     placebo with the option to switch to duloxetine if they do not improve. The third group will~     receive supportive clinical visits the option to switch to duloxetine if they do not~     improve. This design will allow us to determine whether a sequenced treatment of a placebo~     without deception and then the option to switch to an antidepressant is a viable strategy.~     It will also help us to determine to what degree the benefit comes from the ritual of~     receiving and taking the placebo tablet versus the benefit of visits with a doctor alone.~     The primary hypothesis is that there will be a less than 5% difference between response~     rates after 12 weeks in the sequenced placebo-then-antidepressant treatment group (both~     subjects who have remained on placebo as well as those who have switched to the~     antidepressant will be considered as one group) compared to the immediate antidepressant~     therapy group.~   "
107427|NCT01650727|"~     The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib~     therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small~     lymphocytic lymphoma (SLL).~   "
107428|NCT01650714|"~     The proposed study will assess the efficacy and safety of the innovative endoscopic~     technique for the acquisition of full thickness gastric muscle wall biopsies. Having access~     to full thickness biopsies will allow an increased understanding of the pathophysiology of~     gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,~     pseudoobstruction and other motility disorders. This information is essential to development~     of more targeted and effective therapy than currently available. Despite the high prevalence~     of functional gastrointestinal disorders and its significant impact on social and health~     care costs, the underlying cause is not well understood and there is no effective specific~     treatment to successfully alleviate patient symptoms.~   "
107429|NCT01650701|"~     The purpose of this study is to find out if lenalidomide when given along with rituximab can~     help to control the disease and also increase the length of your response (complete or~     partial response) compared to the standard of care rituximab chemotherapy treatment.~   "
107467|NCT01650207|"~     Shoulder pain has been reported to be one of the most common complications after stroke.~     Several factors have been related to shoulder pain after stroke such as paralysis,~     restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the~     relationship between these factors and pain was not discussed.~      The aim of this study is to identify the efficacy of electroacupuncture in reducing upper~     limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life~     (QOL) for stroke patients.~   "
111100|NCT01602042|"~     The purpose of this study is to evaluate the utility of a portable motion sensor-based~     system designed to monitor essential tremor (ET) to better prescribe therapy to minimize~     symptoms and expand care for ET patients.~   "
107430|NCT01650688|"~     Epiblepharon is a very common condition among Asian children and is a fold of the skin and~     underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the~     lashes against the cornea. It is manifested by the anterior lamella overriding the posterior~     lamella which causes the lashes to brush against the cornea. Although the prevalence of~     epiblepharon is known to be high among Asians, its cause remains controversial. Several~     etiological factors may be involved in the pathogenesis of epiblepharon.~      Although epiblepharon in the lower lids lessens and disappears with age in many cases,~     surgery must be performed at an early age in severe cases in order to prevent ocular trauma~     as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced~     keratitis and astigmatism are indications for surgical intervention.~      Over our many years of surgical experience, the investigators came to realize that the~     severity of epiblepharon was reduced when patients were under general anesthesia during~     surgery. The purpose of this study was to investigate the role of the orbicularis muscle in~     the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of~     epiblepharon in the upright versus the supine position and before and after the induction of~     general anesthesia.~   "
107431|NCT01650675|"~     The purpose of this study is to assess the validity of an indirect computer-delivered~     screener for drug use and assess the efficacy of a computer-delivered brief intervention~     with urban post-partum women at-risk for substance abuse and HIV during the post-partum~     period.~   "
107432|NCT01650662|"~     Infarct size is a major determinant of prognosis after myocardial infarction (MI). It has~     been reported that Cyclosporine A (CsA) administered immediately prior to percutaneous~     coronary intervention (PCI) significantly could reduce reperfusion injury and consequently~     infarct size in ST elevation MI (STEMI) patients.~      CYCLE trial is a multicenter, controlled, randomized open label study, with blind assessment~     of endpoint measures. The objective is to determine whether a single i.v. dose of CsA within~     6 hour onset of symptoms of STEMI in 444 patients, improves outcomes after successful~     primary PCI, by reducing myocardial injury associated to reperfusion.~   "
107433|NCT01650649|"~     The primary objective of this study is to assess QTc (an interval of the heart rhythm)~     interaction effects between lofexidine and methadone. The secondary objectives of the study~     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring~     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)~     and adverse events (side effects) when co-administered with methadone; to describe effects~     on opiate withdrawal when lofexidine is introduced following a 50% methadone dose reduction,~     as required to elicit a withdrawal response; and to evaluate the QTc interaction effects of~     lofexidine compared with placebo. The investigators hypothesize that while both agents~     (lofexidine and methadone) are known to prolong the QTc interval, the combination of the~     drugs will not create an additive effect which creates a significant safety concern. The~     investigators further hypothesize that subjects will be able to tolerate the therapeutic~     dose of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered~     to elicit withdrawal.~   "
107434|NCT01650636|"~     The purpose of this study is to test the effects of a videotelephone-delivered~     patient-partner dual-focused cognitive behavioral stress management intervention on chronic~     fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in~     patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that~     videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM)~     intervention improves patient CFS symptoms relative to a videophone-delivered~     patient-partner Health Information (PP-T- HI) condition.~   "
107435|NCT01650623|"~     The aim of this study is to compare two physical therapy training consisting of gait~     training that are distinguished by one being associated with tasks that require handling of~     the main executive functions, performed by individuals with Parkinson's Disease.~      The investigators hypothesis is that the experimental group (EG), which hold gait training~     with higher cognitive demands (dual-task condition), will make improvements in the~     parameters measured (functionality of gait and cognitive ability) to a greater extent~     compared to the control group (CG), which hold gait training without executive tasks~     (single-task condition).~   "
107436|NCT01650610|"~     The aim of this study is the development and implementation of a new protocol of a physical~     therapy training, based on a gait training associated with executive tasks, for treatment of~     individuals with Parkinson's Disease.~      The hypothesis is that this group of patients who will carry out training of this study~     protocol will show improvement in measured parameters (functionality of gait and cognitive~     ability), which allows this protocol to be improved and published as a proposal of~     physiotherapeutic treatment.~   "
107437|NCT01650597|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     single ascending doses as well as repeated doses of JNJ-42165279 in healthy male~     participants.~   "
107438|NCT01650584|"~     To evaluate the comfort preference of ISTA Tears vs Systane in patients with dry eye disease~     (DED). There will also be an assessment of changes in ocular surface disease index (OSDI)~     score along with changes in worse symptom.~   "
107439|NCT01650571|"~     Currently, standard wound care practice is suboptimal at assessing wound remodeling and~     bacterial infection in real-time. An alternative and complimentary means of providing~     real-time imaging of connective tissue re-modeling and bacterial infection may greatly~     increase the early detection of infection thus leading to rapid therapeutic intervention.~     Our new device, PRODIGI(TM), images tissue and bacterial autofluorescence (without agents)~     and may provide this clinically-important capability.~      In preliminary preclinical testing, the investigators have discovered that when wounds are~     illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a~     characteristic green fluorescent signal, while most pathogenic bacterial species emit a~     unique red fluorescence signal due to the production of endogenous porphyrins. Therefore,~     with autofluorescence imaging, no exogenous contrast agents are needed during imaging,~     making this approach particularly appealing as a diagnostic imaging method for clinical use.~      The investigators hypothesize that real-time imaging of tissue autofluorescence signals~     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within~     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound~     closure), detect wound bacterial contamination and/or infection that is occult under~     standard clinical white light evaluation, and guide intervention and wound care.~   "
107440|NCT01650558|"~     The purpose of this study is to determine if there is a benefit to taking~     trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral~     load suppression and a good clinical response on anti-retroviral therapy (ART). If there is~     a benefit, then is it due to antimalarial or antibacterial properties.~      The investigators hypothesize that there will be a long-term benefit on survival and disease~     control in the context of prophylaxis and that the benefit will largely be attributed to~     prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will~     decrease the rates of morbidity and mortality among adults after 6 or more months of ART and~     2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4~     cell counts than TS prophylaxis or no prophylaxis.~   "
107441|NCT01650545|"~     This is a single-center pilot study to investigate the efficacy and safety of aerosolized~     liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients~     with bronchiolitis obliterans syndrome (BOS).~      The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the~     treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary~     end points.~   "
107442|NCT01650532|"~     The investigators propose to test the effects of an 8-week supervised, site-based, group~     yoga intervention on cognition and functional fitness in older adults. The SAY Exercise~     study will compare the yoga group to a stretching group to determine if the program improves~     attention and cognition, reduces functional limitations, enhances functional performance in~     everyday activities, as well as psychological health in sedentary older adults between 55-80~     years of age. The investigators also propose to assess heart rate variability using a 3-lead~     EKG and salivary cortisol levels to understand the moderators of the yoga-cognition~     relationship.~   "
107443|NCT01650519|"~     The intent of this study is to assess the analgesic efficacy of IV ibuprofen when~     administered at induction of anesthesia. Results from this pilot study will be used to~     design and determine the appropriate statistical power for a larger, multi-center randomized~     study.~   "
107444|NCT01650506|"~     Extended phase 1 trial of combined metformin and erlotinib in advanced triple negative~     breast cancer patients.~   "
107445|NCT01650493|"~     Three toothpastes will be compared, two toothpastes in each subject, to establish whether~     changes in the depth or area of an artificially created area of tooth decay is the same for~     each toothpaste.~   "
107446|NCT01650480|"~     The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD)~     assessment, undertaken during or immediately after a hospital admission, which addresses the~     holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).~   "
107447|NCT01650467|"~     The main objective of this study is to evaluate the existence of a relationship between the~     presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence~     of primary resistance to the treatment of CML by imatinib.~   "
107448|NCT01650454|"~     The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the~     aging of the population is a major issue of public health. The prevalence of sleep~     disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by~     prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening.~     The presence of these sleep disturbances is the main reason for the institutionalization of~     AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The~     MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive~     impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center~     of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion~     and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home,~     2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary~     melatonin dosage, neuropsychological tests battery, a virtual reality tool and~     questionnaires will be used.~   "
107449|NCT01650441|"~     The objective of this study is to evaluate the effect of the combination of formoterol and~     beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral~     airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will~     be used. Further more, the effect of this combination therapy on lung function (spirometry,~     resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control~     Questionnaire (ACQ) will be assessed and the safety will be evaluated.~   "
107450|NCT01650428|"~     The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/~     bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer~     as defined by MRI.~   "
107451|NCT01650415|"~     This randomized placebo-controlled trial aims to investigate the efficacy and safety of~     erythropoetin for children with cerebral palsy.~   "
107452|NCT01650402|"~     This study will evaluate different treatment strategies for high blood pressure using~     medications approved by the US Food and Drug Administration (FDA) for the treatment of high~     blood pressure. The study will compare the effects of an intensive reduction of 24-hour~     average blood pressure to a standard reduction of 24-hour mean blood pressure on controlling~     declines in mobility (speed and agility of walking) and cognition (ability to think and~     process information) in an aging population.~   "
107453|NCT01650389|"~     Rationale: The Bacille Calmette-Guérin (BCG) vaccine protects children against disseminated~     tuberculosis (TB) including TB meningitis and miliary TB, but efficacy against pulmonary TB~     is inconsistent among children and adults. Administration of live attenuated BCG to infants~     known to be HIV infected is contraindicated by the World Health Organization (WHO), due to~     the risk of serious vaccine adverse events (BCG disease. Developing countries, which lack~     capacity for integration of early infant HIV testing with infant vaccination schedules, have~     not fully implemented the WHO guidelines on BCG vaccination of HIV exposed infants. Newborn~     infants of HIV infected mothers continue to receive routine BCG before HIV infection has~     been excluded.~      Clinical trials of new viral-vectored TB vaccines, including MVA85A, a modified vaccinia~     virus Ankara (MVA) vaccine expressing the Mycobacterium tuberculosis antigen 85A, have to~     date enrolled infants who were already vaccinated with routine BCG at birth. However, TB~     vaccination regimens that depend on newborn BCG will remain unsafe for HIV infected infants.~     Infants of HIV infected mothers, who constituted 29% of babies born in South Africa in 2009,~     would benefit from a new TB vaccination strategy, in which BCG is delayed until after HIV~     infection has been excluded. These HIV exposed infants also have greater increased risk of~     TB disease. Testing the safety and immunogenicity of MVA85A vaccine prime, followed by~     selective delayed BCG boost, in HIV exposed newborns, is a critical step towards delivery of~     a new TB vaccine regimen that is safe and effective for all infants, regardless of HIV~     exposure.~      Study Design: Double blinded, randomised, controlled trial. HIV exposed infants will be~     randomised 1:1 to receive single dose, intradermal MVA85A vaccine or Candin® control at~     birth. The first 60 infants enrolled in the trial will form a pilot safety cohort for formal~     Data Monitoring & Ethics Committee (DMEC) safety review. Thereafter, safety and~     immunogenicity outcomes will be measured in all infants.~      Study Population: Infants (n=340) born to HIV infected mothers receiving antiretroviral~     therapy (ART) or Prevention of Mother to Child Transmission (PMTCT) prophylaxis.~      Sites: Worcester (University of Cape Town) and Khayelitsha (Stellenbosch University), South~     Africa~      Study Intervention: Newborn infants will receive 1 x 108 pfu MVA85A vaccine or Candin®~     control by intradermal injection. Infants confirmed HIV uninfected by HIV PCR will receive~     BCG Vaccine SSI at 8 weeks of age. Infants confirmed HIV infected by HIV PCR will not~     receive BCG.~      Primary specific aims:~      To evaluate the safety of MVA85A given at birth to HIV exposed uninfected infants.~      To evaluate the safety of BCG given at 8 weeks of age to HIV exposed uninfected infants,~     using an MVA85A prime and BCG boost strategy.~      Secondary specific aims:~      To evaluate the immunogenicity of MVA85A given at birth to HIV exposed uninfected infants.~      To evaluate the immunogenicity of BCG given at 8 weeks of age to HIV exposed uninfected~     infants, using an MVA85A prime and BCG boost strategy.~      Safety endpoints:~      Local, regional, and systemic adverse events (AEs) and serious adverse events (SAEs).~      Immunology endpoints:~      Frequencies of CD4 and CD8 T cells producing any of 4 cytokines (IL-17, IFN-γ, TNF-α, or~     IL-2), or polyfunctional combinations of these cytokines simultaneously, following~     stimulation with antigen Ag85A or BCG, measured by whole blood intracellular cytokine assay~     (WB-ICS).~      Specific proliferative capacity of CD8 and CD4 T cells that produce any of the three~     cytokines (IFN-γ, TNF-α, and/or IL-2) or combinations of these cytokines simultaneously,~     measured by a novel whole blood 6-day lymphoproliferative flow cytometric assay (WB-prolif).~      Relative proportions and absolute numbers of peripheral blood myeloid and lymphoid cell~     subsets, measured directly ex vivo by flow cytometry.~      Study groups: The first 60 infants enrolled in Study Group 1 will undergo intensive safety~     evaluation, followed by DMEC review of Day-28 safety data. The DMEC will make a formal~     recommendation on continuation of enrollment and/or changes to the protocol, based on this~     safety review. Study Groups 2-5 will be evaluated for clinical safety and immunology~     outcomes.~      Statistical Analysis: Cumulative 12-month incidence of local, regional, and systemic AEs, by~     category, will be compared for HIV exposed uninfected subjects receiving MVA85A vaccine or~     Candin® control at birth. The sample size has 90% probability of detecting an SAE with a~     true occurrence rate of 1.5% in infants receiving MVA85A vaccine and 80% power to detect a~     15% difference in the rate of non-serious AEs (20% compared to 35%) between the two study~     arms (p<0.05). Multivariate models will be built to explore longitudinal immunological data~     and identify independent associations with MVA85A vaccination and covariates of interest.~   "
107454|NCT01650376|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of the~     investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in~     patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators~     intend to study the safety and tolerability of the study treatment, response to treatment,~     time to disease progression, and overall survival.~   "
107468|NCT01650194|"~     The purpose of this study is to explore the safety and tolerability of enzalutamide in~     combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the~     prostate that is getting worse and spread to the bone despite receiving hormone treatment~     will be enrolled and receive study treatment until disease progression.~   "
107531|NCT01649362|"~     The objective of this study is to evaluate the efficacy of an oral stimulation program on~     the length of the transition period in preterm infants (primary outcome), the length of~     hospital stay and the breastfeeding rates at discharge (secondary outcomes).~   "
107532|NCT01649349|"~     The purpose of this studyis to assess the feasibility and safety of novel designed two-piece~     nasogastric tube.~   "
107455|NCT01650363|"~     This is a randomized controlled clinical trial in which the combination of 4 different CAM~     modalities (Complementary & Alternative Medicine) will be applied during the postoperative~     period to patients undergoing open heart- or lung surgery and expected to be hospitalized~     for more than 5 days.~      Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a~     control group. The treatment group will be treated with a combination of 4 different CAM~     modalities (Homeopathy, Osteopathy, and Acupuncture & Reflexology) . The control group will~     be treated with Homeopathic placebo medication.~      The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire~     (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary~     outcome measurements will be Blood &Saliva Cortisol levels, DHES levels in the blood as~     surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be~     measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI~     symptoms (nausea, first bowel movement), post-operative complications& side effects.~      All patients participating in the trial will sign an informed consent form . The trial is~     expected to be conducted over a period of 12 months. Prior to the trial a pilot study will~     be conducted on a group of 30 patients in order to determine the needed sample size for the~     trial.~   "
107456|NCT01650350|"~     will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory~     solid tumors within the context of a phase II clinical study~   "
107457|NCT01650337|"~     BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed.~     In March 2012, experts estimated that 40,000 health related smartphone applications were on~     the market but little is known about the effectiveness of these programs. To our knowledge,~     no studies have evaluated whether weight loss can be successfully achieved through use of a~     smartphone application or how these applications could be used in primary care practice.~      PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight~     loss and calorie counting in a primary care setting.~      METHODS: The first phase of this study involved a community based participatory approach to~     select the intervention. Patient focus groups were conducted and analyzed to explore~     patients' preferences regarding various text-message versus smartphone programs. The second~     phase of this study, described here, will be a randomized controlled trial with overweight~     primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2)~     usual care plus smartphone application, which includes instructing participants on how to~     use the application and encouraging them to use the applications' reminders and social~     networking features. The primary outcome of interest is weight change at 3 and 6 months.~     Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between~     groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting~     for covariates such as education, sex and age. Repeated measures analysis will be carried~     out to compare weight change between the groups using baseline, 3 month and 6 month data. In~     addition to an intent-to-treat analysis, the investigators will also conduct a treatment~     received analysis, adjusting for the extent of application use in both the intervention and~     control arms.~      CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in~     primary care settings and incorporated into the visit can produce weight loss. Study~     findings could inform a national discourse on the value of smartphone applications in~     routine clinical practice.~   "
107458|NCT01650324|"~     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK)~     and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male~     subjects.~   "
107459|NCT01650311|"~     Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in~     ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in~     enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients.~     Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT~     production, messenger RNA (mRNA) have been found in CD patients in remission who are~     suffering the irritable bowel syndrome (IBS)-like symptoms. Alterations in normal 5-HT~     signaling has also been reported in animal models of inflammatory bowel disease (IBD). Thus,~     the aim of the proposed research project will be to study the alterations in 5-HT signalling~     accompanying GI inflammatory conditions, such as IBD.~   "
107460|NCT01650298|"~     The purpose of this study is to determine whether it is safe to stop anticoagulation~     medication in patients with a history of atrial fibrillation (AF) based on information from~     a pacemaker or implantable cardioverter defibrillator (ICD).~   "
107461|NCT01650285|"~     There is a high relapse rate for patients who have undergone prostatectomy and have~     pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle~     involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free~     and overall survival, approximately half of these patients will develop recurrence.~     Similarly, radiation therapy has become the standard salvage therapy for patients with~     rising PSA >0.1 - < 2.0 ng/mL. In common solid tumors such as NSCLC, head and neck cancer~     and upper gastrointestinal cancers, the addition of chemotherapy to radiation improves~     survival. It is hypothesized that the addition of radiosensitizing chemotherapy to standard~     adjuvant radiation will improve survival in patients with stage 3 prostate cancer after~     prostatectomy and patients with rising PSA < 2.0 ng.mL without detectable disease. Taxanes~     are powerful radiation enhancers since they synchronize tumor cells in G2/M the most~     radiosensitive phase of the cell cycle.17,18 Cabazitaxel is the most active taxane in the~     treatment of prostate cancer. Therefore, we propose a phase I study establishing the optimal~     dose of cabazitaxel with adjuvant radiation for stage 3 prostate cancer after prostatectomy~     (PSA undetectable - < 2.0 ng/mL). and for patients with persistent or rising PSA post~     prostatectomy (PSA >0.1 - < 2.0 ng/mL).~   "
107462|NCT01650272|"~     5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic~     alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5%~     Minoxidil in solution is the first choice preparation for treatment, therefore allergic~     contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol~     which is the main solvent of these solution, was the main responsible to allergic contact~     dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the~     alternative solution using butylene glycol as the solvent was invented to solve the problem.~     In Siriraj hospital the investigators using this new solvent and made our in house product~     called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have~     not been investigated. This study is conducted to evaluated efficacy and safety of 5%~     Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.~   "
107463|NCT01650259|"~     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as~     monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics~     of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral~     antidiabetic monotherapy (naïve or switched from prior therapy of different oral~     antidiabetic drug).~   "
107464|NCT01650246|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad over a~     long-term timeframe.~   "
107469|NCT01650181|"~     Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the~     upcoming years, the economic burden of this disease will increase and will mean an important~     problem for our health system due to obesity epidemic.~      There are several treatments for non-alcoholic steatohepatitis; however, none of them have~     overcome a healthy lifestyle including diet, exercise and some drugs related with insulin~     metabolism.~      There after, using hepatoprotective drugs and antioxidants have been recommended as an~     eligible therapy to reduce the progression from fatty liver to steatohepatitis and~     cirrhosis. Being this approach not only an experimental item yet but also an unavoidable~     reality.~      The purpose of this randomized controlled study is explore the effects of~     siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with~     fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic~     parameters.~   "
107470|NCT01650168|"~     This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed~     dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined~     oral contraceptives (COC-LNG) in a study population representative of the actual users of~     the individual preparations.~   "
107471|NCT01650155|"~     To investigate the safety and tolerability of BI 1005273 in healthy male volunteers~     following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.)~     injection. Secondary objectives are the exploration of the pharmacokinetics and early~     pharmacodynamics of BI 1005273.~   "
107472|NCT01650142|"~     Thanks to the investigators previous study the investigators demonstrated the influence of~     modifying genes in the phenotypic expression of neurofibromatosis 1 (Hum Mol Genet. 2009; 18~     (15) :2768-78). Indeed, analysis of the intra-and inter-family variability performed using~     the investigators phenotype/genotype database demonstrated a strong genetic component for~     most clinical features. The investigators results suggest the involvement of genetic~     factors, not related to the NF1 gene, the modifiers. The objective of this project is to~     identify the modifiers involved in the variability of clinical expression of NF1. The~     investigators will focus in particular variants involved in the development and progression~     of neurofibromas.~   "
107473|NCT01650129|"~     This trial is conducted in Japan. The aim of this trial is to investigate the safety and~     efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human~     insulin (BHI) 50 in subjects with type 2 diabetes.~   "
107474|NCT01650116|"~     The purpose of this study is to verify any existing relationship between urinary parameters~     (such as excretion of sodium, chlorine, urinary partial CO2 pressure [PuCO2]) and general~     volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.~   "
107475|NCT01650103|"~     The purpose of this study is to verify any existing relationship between mixed oxygen~     saturation (from central venous catheter) and urinary sodium, potassium, chloride in~     determining the volemic state and renal perfusion of patients undergoing major surgical~     interventions.~   "
107476|NCT01650090|"~     To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in~     delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical~     remission following one or two prior pulmonary relapses.~   "
107477|NCT01650077|"~     Non-interventional study consisting of a population of patients who had received for soft~     tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after~     failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.~   "
107478|NCT01650064|"~     The purpose of this study is to estimate the survival proportion one year after surgery for~     intertrochanteric fracture in older adults in Latin America.~   "
107479|NCT01650051|"~     The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets,~     USP 200 mg as a short term analgesic treatment of pain upon urination associated with~     Uncomplicated Urinary Tract Infections (uUTI).~      The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine~     HCl Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination~     associated with uUTI.~   "
107480|NCT01650038|"~     Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon.~     Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early~     adulthood and lead to life-long substantial morbidity. There is no medical treatment~     available that meets the desired criteria of high efficacy versus low adverse effects. The~     current prevailing hypothesis regarding the cause of UC states that the pathogenesis~     involves an inappropriate and ongoing activation of the mucosal immune system driven by the~     intestinal microbiota in a genetically predisposed individual. Systematic investigation into~     the effect of correcting the dysbiosis in ulcerative colitis patients has never been~     performed. The most radical way to restore the presumably disturbed natural homeostasis in~     UC is to perform faecal transplantation from a healthy donor. In this trial the potential~     beneficial effects of restoring microbial homeostasis by faecal transplantation through a~     duodenal tube will be studied in a phase II randomised placebo controlled design.~      Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks~     (primary), as well as time to recurrence, intra individual changes in faecal samples and~     mucosal biopsies. Follow up is 12 months.~   "
107481|NCT01650025|"~     Obesity in children has become a significant social problem considering that nowadays 4 to 5~     % of all children are obese in the industrialized countries with increased incidence in~     Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic~     syndrome in 30% of the children and is considered as a state of chronic inflammation~     inducing the production of pro-inflammatory cytokines which determine metabolic and~     endocrine alterations on the organism. It has been observed that obesity is also linked to a~     change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and~     a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative~     analysis of the metabolites may provide us with a characterization of the existing~     phenotypes and variations in relation to the changes of the physiological state, in~     particular when supplemented or not with a probiotic preparation.~   "
107547|NCT01649141|"~     This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive~     Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the~     treatment of child sexual abuse, can be effectively transported to a state-contracted~     community mental health agency in the state of Delaware and used effectively by clinicians~     with little prior TF-CBT experience. The sample is comprised of youths receiving public~     mental health services and with diverse trauma histories.~   "
107482|NCT01650012|"~     Forty percent of patients that require dialysis for kidney failure die within three years~     mostly due to heart disease. Heart failure and high blood pressure are common problems in~     patients that require dialysis and are key causes of death due to heart disease. Eplerenone~     is a drug that is very effective at improving heart failure and reducing blood pressure in~     patients that do not require dialysis. There is currently no evidence to tell physicians~     whether eplerenone would have similar benefits in patients that require dialysis. This~     evidence can only be reliably generated by performing a large scale study. Before such a~     study is undertaken, the investigators must determine whether eplerenone will be well~     tolerated and safe in patients that require dialysis. The investigators will perform an~     initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone~     antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe~     medication to use in a very large, global study that will show whether or not eplerenone~     reduces important outcomes for patients like death from heart causes.~   "
107483|NCT01649999|"~     This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the~     dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects~     given ASP015K for 12 weeks.~   "
107484|NCT01649986|"~     Cardiovascular prevention include a class I indication to statins in addition to~     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high~     risk' according to current scientific guidelines. In the real world, however, statin~     treatment is often discontinued due to side effects.~      In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom~     only non-pharmacologic intervention and prevention strategies are currently prescribed.~      Along with non-pharmacologic intervention and prevention strategies, newer approaches to~     reduce cholesterol blood levels currently include nutraceuticals, which are compounds~     derived from foods with cholesterol lowering actions.~      The primary objective of this study is twofold:~      First, to prospectively compare in the real world clinical practice the efficacy and~     tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic~     intervention with a nutraceutical-based protocol in patients in whom statin treatment is not~     tolerated or is not indicated.~      Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a~     nutraceutical-based protocol among European countries.~   "
107485|NCT01649973|"~     Laryngeal view of the patient and anesthesiologist's discomfort level during endotracheal~     intubation in relation to the various heights of operating table has not been investigated.~     The investigators hypothesis is higher table height will improve the laryngeal exposure.~   "
107486|NCT01649960|"~     The investigators will do the study in two phases. The first phase will be a pilot study on~     up to 18 participants [patients 60 years or older with coronary artery disease (CAD)~     undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)~     or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up~     to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the~     duration of CR. Baseline and follow-up data will be collected for age-associated impairment~     (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory~     phenotype (SASP)and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte~     mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes.~     Safety of rapamycin will be assessed by periodic clinical follow-up, blood draws, and serum~     rapamycin levels. Following completion of the pilot phase, the data will be analyzed. If~     favorable changes are noted in the SASP or AAI, the investigators will start a phase 2~     randomized trial.~      Second phase: In a prospective, randomized, clinical trial design, patients 60 years or~     older will be randomized at the time of CR to a standardized exercise protocol, or exercise~     protocol with the addition of low-dose rapamycin to test the hypothesis whether low-dose~     rapamycin (demonstrated in the pilot trial to improve SASP/AAI) will improve measures of~     AAI, SASP, or findings on the fat biopsy as compared to exercise alone. The null hypotheses~     are that there is no improvement with rapamycin in measures of AAI or SASP.~   "
107487|NCT01649947|"~     The purpose of this study is to examine the combination of one standard treatment for lung~     cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer~     being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients~     who have a specific type of lung cancer can also receive another drug, a drug that targets~     blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA~     approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.~   "
107488|NCT01649934|"~     The purpose of the current pilot study will be to utilize implementation intentions to~     increase patient compliance with appointment attendance. Participants in the current study~     will be individuals referred for evaluation of their treatment needs. Experimental groups~     will create a simple induction consisting of what/when/where statements (implementation~     intentions) with the intention of increasing their rate of calling to schedule and~     subsequently attend appointments associated with their care. It is anticipated that~     participants who take an active role in their plan and utilize the implementation intention~     procedures will be more likely to make and attend the appointments suggested by their~     treating clinician. This pilot project will provide valuable initial data as to the~     potential effectiveness of a simple, cost-effective means of increasing appointment~     attendance. If successful, it could lead to cost savings and a decrease in the appointment~     wait time for people by increasing the utilization of available appointments.~   "
107489|NCT01649921|"~     The primary aim of this study is to assess the effects of adjunctive therapy with Interferon~     (IFN)-gamma on immune function in patients with septic shock in a placebo-controlled manner.~     Moreover, the investigators want to evaluate new markers that could be used to identify~     patients with immunoparalysis, and to monitor the patient's immunological response to IFN-γ.~     In addition, mechanistic studies will be performed to further elucidate mechanisms (such as~     epigenetic modifications) behind immunoparalysis and the effects of IFN-γ on these~     mechanisms. With use of the results the investigators will obtain in this pilot study, the~     investigators will conduct a large multicentre clinical trial with IFN-γ.~   "
107490|NCT01649908|"~     Different cross clamping techniques in aortic surgery causes different cardiac stress~   "
107491|NCT01649895|"~     The purpose of this study is to examine if D-Cycloserine is an effective adjunct to~     internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.~   "
107492|NCT01649882|"~     Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To~     date, no test that can verify this right after intubation at the bedside exists. Indirect~     tests have false negative and positive results leading to complications or at least~     difficulties in performing effective ventilation of patients.~      Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or~     useful in routine intubations, it may prove useful in difficult or questionable cases, where~     current clinical exams/techniques may not offer a reliable indication of endotracheal tube~     depth.~   "
107493|NCT01649869|"~     Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to~     ganciclovir on absorption. Valganciclovir is approved for the treatment of Cytomegalovirus~     (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and for the~     prevention of CMV disease in kidney, heart, and kidney-pancreas high-risk transplant~     patients. The formulation used in this study will be valganciclovir oral solution which is~     commercially available. It will be provided as a 12g powder containing 5g valganciclovir~     free base. The oral solution formulation comprises the following excipients: Providone K30,~     fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water. The~     valganciclovir oral solution formulation does not contain lactose anhydrous.~      The placebo comparator will be commercially available Simple Syrup (Syrup NF) as 60-90%~     sucrose in purified water.~   "
107494|NCT01649856|"~     This multicenter, randomized, open label parallel-group study will evaluate the efficacy and~     safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with~     CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell~     lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg~     subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8~     cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study~     treatment is 6 months.~   "
107495|NCT01649843|"~     Achalasia is a rare esophageal motility disorder, which is characterized clinically by~     symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are~     primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal~     sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus.~     Unfortunately, no therapy returns normal esophageal function. Treatment is therefore~     directed at lowering the LES pressure, with the aim of reducing the functional obstruction~     to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral~     endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic~     myotomy technique intending a permanent cure from primary achalasia in some centers. The~     investigators purpose was to further evaluate the efficacy and the feasibility of POEM for~     patients with achalasia in a prospective larger study.~   "
107496|NCT01649830|"~     Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative~     nature and frequent growth in eloquent area in brain often makes total resection impossible.~     Until now, no agreement has been achieved on the treatment of LGG without total resection.~     Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade~     gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas.~     However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to~     be defined. In this randomized controlled trial, the investigators will test the hypothesis~     that radiotherapy with subsequent TMZ chemotherapy is superior to improve the~     progression-free survival of patients with residue LGG without significant impairment to~     quality of life compared to radiotherapy alone.~   "
107497|NCT01649817|"~     This multicenter, retrospective observational study will evaluate compliance an reasons for~     withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with~     intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be~     collected from each eligible patient over a period of 6 months.~   "
107498|NCT01649804|"~     This extension study of WA19926 will assess the long-term safety and the efficacy of~     RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis.~     Participants who have completed the core study WA19926 are eligible to participate.~     Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The~     anticipated time on study drug is 104 weeks.~   "
107499|NCT01649791|"~     This clinical trial studies lenalidomide as chemoprevention in treating patients with~     high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the~     use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease~     progression in patients with early stage B-cell chronic lymphocytic leukemia~   "
107500|NCT01649778|"~     This is a global, multi-centre, long-term, prospective, observational study to evaluate~     treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated~     for the first time with pazopanib. The study is designed to enroll approximately 700-1000~     patients in over the course of an enrollment period of approximately 18 months.There are no~     protocol-mandated visits or procedures associated with the study. Each patient is expected~     to participate for a maximum of 30 months or until premature discontinuation (i.e., due to~     death, withdrawal of consent, lost to follow-up or study termination).~   "
107501|NCT01649765|"~     This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of~     belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic~     lupus erythematosus~   "
107513|NCT01649609|"~     BK virus infections after kidney transplant are increasing and can result in damage to the~     transplanted kidney. Currently, the universally accepted treatment is to decrease the~     strength of the antirejection medications but it is unclear what medications should be~     lowered and to what extent. The investigators propose to perform a study with patients who~     have BK virus detected in their blood during routine screening that appears to be~     increasing. The investigators will use two different strategies that involve different~     combinations of standard anti-rejection medications at lower dosages. Patients will be~     assigned to one of the two groups in a random manner across the two hospitals participating~     in the study. Patients will be followed for at least a year to determine if one strategy was~     more effective than the other in preventing an increase in the number of viruses in the~     blood stream and whether either one was more effective in reducing the negative impact of~     the infection on the functioning of the transplanted kidney.~   "
137828|NCT01250938|"~     The purpose of this study is to test the applicability of a caregiver-implemented autism~     intervention protocol to a deliberately recruited low-income, underserved population.~   "
107502|NCT01649752|"~     Background:~      Improving implantation rates in ICSI cycles has been the focus of research in recent~     decades. Because success rates is not satisfactory enough especially when transferring good~     embryos to the uterine cavity and pregnancy does not occur. Trying to improve endometrial~     receptivity, the investigators have thought about stem cell therapy as stem cells have~     played a pivotal role in regenerative medicine in many pathologies as myocardial infarction,~     Diabetes Mellitus and spinal cord injuries.~      Garget and Healy reported in 2011 treatment of a case with Asherman's syndrome by~     administration of bone marrow stem cells in the uterine cavity. Endometrial growth and~     improved vascularity has been observed by ultrasound follow-up and Doppler study of~     endometrial blood flow. Endometrial regeneration has been enough to support pregnancy~     through successful IVF trial.~      The investigators have succeeded in previous work to isolate MSC from placental tissue and~     differentiate it to endometrium-like cells. The investigators compared the differentiation~     ability of placental derived mesenchymal stem cells (MSC) and Wharton Jelly derived MSC to~     differentiate to endometrium under 3 different culture conditions: endometrium conditioned~     medium (ECM), follicular fluid (FF) conditioned medium and medium containing both. The~     investigators found that placental MSC has better differentiating ability to endometrium~     especially under culture conditions containing both ECM and FF as evidenced by prominent~     appearance of glandular pattern and expression of progesterone receptors in differentiated~     cells.~      Therefore the investigators need to direct this study and test the effect of placental~     derived MSC in improving implantation rates in patients with recurrent implantation failure,~     unresponsive endometrium to ovulation induction drugs or with endometrial atrophy or~     advanced maternal age planning for ICSI trial.~      Patients and Methods:~      60 patients attending Kasr El-Aini assisted reproduction unit and private IVF center will be~     randomized to three groups by computer generated programs:~      The first group, patients randomized to receive differentiated stem cell therapy:~      After ovum pick-up, MSC differentiated to endometrium is deposited in the uterine cavity~     through an IUI catheter. Embryo transfer will be done at day 5 at the blastocyst stage to~     allow enough time for endometrial regeneration and increased endometrial receptivity.~      The second group, patients randomized to receive undifferentiated stem cell therapy:~      Immediately postmenstrual undifferentiated MSC is deposited in the uterine cavity through an~     IUI catheter to allow enough time for the MSC to differentiate as it needs 7-10 days for~     differentiation. Ovum pick-up will be done as usual while all other steps will be the same~     including embryo transfer which will be done at day 5.~      The third group, control group:~      Patients are randomized to receive no stem cell therapy; All ICSI steps from ovulation~     induction protocol to embryo transfer conditions will be the same for all groups.~      Informed consent will be taken from the patients after detailed explanation of all steps of~     the procedure.~   "
107503|NCT01649739|"~     Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality~     of life and inability to function, despite medical therapy Current consensus states that~     combination therapy with different classes of PAH-specific therapy is likely to bring~     additional benefit to PAH patients. In this study we plan to study how exercise performance~     changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain~     symptomatic from PAH when treated with inhaled iloprost.~      Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is~     tolerated by the patients, after a two week period, up titration to 20 mg bid will be~     permitted, at the discretion of the investigators.~      According to treatment protocol up titration will be done carefully and whenever side~     effects will be reported up titration will be stopped or dosage will be decreased or stopped~     according to the investigator judgment.~      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for~     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.~      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for~     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall~     in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of~     the investigator. BP will be measured according to the following protocol.~      Pre-dose Immediately before administration of vardenafil. This will be timed approximately~     one hour prior to the next planned dose of iloprost.~      Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.~      Post-inhalation Immediately following completion of iloprost inhalation and every fifteen~     minutes for one hour.~      Prior to discharge Two hours following the iloprost.~      Later monitoring At all follow-up visits, BP will be measured.~      This is an open-label study to evaluate the safety and efficacy of adding higher doses of~     vardenafil to inhaled iloprost over 3 months.~   "
107504|NCT01649726|"~     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem~     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous~     breathing is established the apnea test (according to the American Academy of Neurology's~     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and~     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some~     data suggest modifying the apnea test : replace the ventilator switching off with continuous~     positive airway pressure (CPAP) use. These studies showed that this alternative method~     (CPAP) increased the level of lung harvest but they were not sufficient because these~     studies were monocentric, non randomized and with little patients,. That why the aim of the~     present study is to compare the standard strategy and CPAP strategy with a prospective,~     multicenter, randomized study.~   "
107505|NCT01649713|"~     This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for~     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15~     μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single~     intramuscular injection of Fluval AB suspension for injection, as measured by~     haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence~     of adverse events) of a single intramuscular injection of Fluval AB suspension for~     injection.~   "
107506|NCT01649700|"~     The study is to investigate the efficacy and safety of autologous transplantation of~     adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain~     injury.~   "
107507|NCT01649687|"~     The study is to investigate the efficacy and safety of allogenous transplantation of~     adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.~   "
107508|NCT01649674|"~     The purpose of this study is to to compare two bowel preparation regimens of patients who~     will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient~     satisfaction.~   "
107509|NCT01649661|"~     The purpose of this study is to learn about how a woman's health history influences what a~     normal breast looks like on an MRI. The investigators also want to learn about how the~     amount of different natural hormones a woman has affects how the breast looks on an MRI. The~     investigator's hope is that this will help to find women at a high-risk of breast cancer.~   "
107510|NCT01649648|"~     This is a pilot study to test feasibility and safety of collection, preparation and infusion~     of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby~     is born with signs of brain injury. The cord blood used is fresh (not frozen and then~     thawed).~   "
107511|NCT01649635|"~     Primary Objective:~      - To assess effectiveness of prophylactic treatment of hematological complications (grade ≥~     3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.~      Secondary Objectives:~        -  PSA response rate;~        -  Descriptive assessment of CTC (circulating Tumor Cells);~        -  Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the~          treatment period;~        -  Description of the Health Quality of Life of the patients;~        -  Incidence of adverse events.~   "
107512|NCT01649622|"~     The goal of this clinical research study is to learn if bendamustine can help to control~     Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.~      Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them~     to die.~   "
107529|NCT01649388|"~     This study involves the use of an enriched hematopoetic stem cell infusion (stem cells,~     produced by the bone marrow) from the same donor who provided the original kidney~     transplant. This kidney transplant may have taken place months to years previously.~   "
140234|NCT01219231|"~     The researchers will investigate whether exercise could provide positive effects on general~     brain functions in elderly people with impaired glucose tolerance.~   "
107514|NCT01649596|"~     The purpose of this proposed study is to evaluate a normothermia protocol that includes~     preoperative warming and standard intra operative temperature management in patients~     undergoing general surgery.~      The study aim is to compare short term outcomes in patients for whom warming is expanded by~     commencing in the pre operative area and is maintained through post operative recovery~     versus patients receiving the standard warming at time of induction.~      The overall study goal is to test for differences in the rate of hypothermic events between~     the two groups.~      A secondary goal is to test for differences in the complication rate and patient~     satisfaction between the two groups.~      This study is testing the hypothesis that expanded warming significantly reduces rates of~     hypothermia and complications over standard warming used only during surgery.~   "
107515|NCT01649583|"~     The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can~     be used during and immediately after cancer treatment. The Dynasplint® is a stretching~     device that is used to treat joint stiffness and limited range of motion in the jaw. The~     device is currently approved for treatment of trismus once it has developed. This study will~     investigate the use of the device during and immediately after cancer treatment to prevent~     trismus.~   "
107516|NCT01649570|"~     This trial is conducted in Japan. The aim of this trial is to investigate the safety and~     efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2~     diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human~     insulin.~   "
107517|NCT01649557|"~     This will be a multicenter, 52 week, open label study to assess the safety and tolerability~     of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study~     will be conducted on an outpatient basis. Enrollment into the study will be drawn from~     eligible subjects who have completed participation in Study 331-07- 203 and who, in the~     investigator's judgment, would benefit from continued treatment with oral OPC-34712.~   "
107518|NCT01649544|"~     In pre-operative cardiac surgery, 30 to 40% of patients with mitral valvulopathy have had~     episodes of paroxysmal atrial fibrillation (PAF) or are in permanent or chronic atrial~     fibrillation (CAF). According to the 1999 PMSI data, close to 4000 mitral valve~     interventions were performed in France, in other words, more than 1000 patients present with~     this condition annually; despite a surgical correction of their valvulopathy, patients~     presenting with a pre-operative chronic atrial fibrillation remain in fibrillation following~     surgery despite treatment with anti-arrhythmic agents associated or not with a~     cardioversion. Thus, the survival rate without AF recurrence is 10% at 1 year and 5% at 2~     years in patients with AF prior to surgery; on the other hand, patients in sinus rhythm at~     the time of surgery and without an antecedent of AF exhibit an incidence of no AF of 90% and~     74% at 1 and 2 years, respectively. It has also been shown in numerous studies that the~     long-term morbidity in patients with atrial valve surgery is higher in those with AF.~      For more than 10 years, radio-frequency techniques using the endocavitary approach have~     shown a greater efficacy in maintaining sinus rhythm than drug therapy even though the~     techniques are invasive. These radio-frequency techniques were developed and tested during~     mitral surgery, but, to the investigators knowledge, there is only one randomized study that~     was carried out in a population with permanent AF using radio-frequency technique via the~     endocardial approach. Maintenance of sinus rhythm was obtained in only 44.4% of patients~     versus 4.5% in the control group; these results are not in accordance with the published~     prospective and retrospective registries using the technique peri-operatively. The principal~     problem of this study is the absence of medical treatment in the control group. In addition,~     the use of the radio-frequency technique requires an atriotomy resulting in a prolonged~     surgical time, which increases the peri-operative morbidity.~      Other simpler ablation techniques have been developed, such as the one using ultrasound. In~     comparison with the radio-frequency method, this latter technique presents numerous~     advantages including the absence of an atriotomy due to the fact that the epicardial pathway~     is used, a short procedure time (11 min on average), excellent reproducibility, the~     transmural character of the lesions, along with the simplicity of application. There is not,~     to the investigators knowledge, a randomized study comparing the peri-operative ultrasound~     technique (EPICOR) in mitral valve surgery with the conservative reference treatment,~     notably mitral valve surgery coupled with long-term amiodarone treatment. In effect, while~     amiodarone is the most efficacious anti-arrhythmic agent in the long-term, this drug is~     associated with a high percentage of significant side effects, close to 20% at 2 years. The~     only available results using the ultrasound technique are the registries pertaining to the~     follow-up of patients undergoing cardiac mitral or aortic surgery, with an antecedent of AF.~     The results appear to be encouraging with 85% of cases maintained in sinus rhythm at 12~     months in the most recent studies. In this clinical context, a French multi-centric registry~     evaluated the peri-operative treatment of AF with all of the proposed techniques~     (cryotherapy, radio-frequency, and ultrasound). The percentage of maintenance of sinus~     rhythm appears to be lower than in the historical registries, at the level of 60%, but the~     techniques used in this registry were multiple even if 50% of patients were treated with~     ultrasound; in addition, there was no randomization and follow-up was only for 6 months.~   "
107519|NCT01649531|"~     The aim of the present study is to test whether there is a difference in the marginal bone~     level change between implants with and without cantilevers.~   "
107520|NCT01649518|"~     Osteoarthritis is the most common affection of joints worldwide. Multiple international~     guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless~     there seems to be a gap between usual care and the preferred one.~      A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy~     was developed by a multidisciplinary expert team. This project aims to map usual care and to~     explore the gaps between usual care and international guidelines in a second stage. This~     will enable us to develop a tightly targeted quality improvement intervention later on.~   "
107521|NCT01649505|"~     The purpose of this study is to investigate the efficacy of an alternative surgical~     technique and the use of fibrin sealant in preventing post-operative seroma formation. A~     seroma is a build-up of clear bodily fluids in a place on the body where tissue has been~     removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to~     10 days after surgery, after the drainage tubes have been removed. The breast area involved~     in the surgery may have a spot that's swollen and feels like there is liquid under the skin~   "
107522|NCT01649492|"~     The goal of this study is to evaluate the actual potential for in vivo pineapple juice~     inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of~     CYP2C9 activity.~   "
107523|NCT01649479|"~     The main objective of this study is to estimate the lifetime prevalence of major psychiatric~     disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV)~     in a large sample of patients with developed clinical signs of pure obstetrical~     antiphospholipid syndrome (suspected APS).~   "
107524|NCT01649466|"~     This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin~     add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate~     glycemic control on their current sulfonylurea monotherapy to give treating physicians a~     guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is~     not sufficient to reach glycemic control.~   "
107525|NCT01649453|"~     The study prospectively assesses the change in cancer-specific clinical decisions and~     outcomes before and after physicians received results from the Pathwork® Tissue of Origin~     (TOO) Test for patients whose primary site of cancer origin is uncertain.~   "
107526|NCT01649440|"~     The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem~     in intensive care units with high morbidity and mortality. The differentiation between~     non-infectious and infectious etiologies, severity and organ function evaluation, and~     prognostic assessment are all challenging in routine clinical practice. Many biomarkers have~     been suggested for these purpose; however sensitivity and specificity even of high-ranking~     biomarkers still remain insufficient. Recently, metabolic profiling has attracted interest~     for biomarker discovery. In this study, LC-MS/MS will be perform to identify serum metabolic~     biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and~     prognostic assessment among 65 patients. The investigators enrolled 35 patients who were~     diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients.~     Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients~     before death. Small metabolites that were present in patient serum samples were measured by~     LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal~     Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and~     Orthogonal Partial Least Squares Discriminant Analysis. Based on the multivariate~     statistical analysis above, the investigators could distinguish sepsis from normal and SIRS;~     distinguish the difference among sepsis, severe sepsis and death. We hypothesis that some~     metabolites as identified in this study are promising biomarker candidates in the field of~     sepsis diagnosis and treatment.~   "
107527|NCT01649427|"~     The purpose of this study is to investigate if Tacrolimus Hexal® has similar pharmacokinetic~     properties compared to Prograf® in de novo renal transplant patients and whether the~     comparable exposure results in similar renal function.~   "
107528|NCT01649401|"~     The main objective of this study is to determine whether the use of the PARI LC Sprint Sp~     nebulizer in the treatment of asthma in children under 36 months reduces the duration of~     hospitalization.~   "
137829|NCT01250925|"~     The purpose of this study is to utilize in-vivo confocal microscopy to describe differences~     in corneal epithelial immune status across three lens care regimens in new contact lens~     wearers.~   "
107533|NCT01649336|"~     This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian,~     fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162~     and paclitaxel. Patients will receive increasing doses of study drug in combination with~     paclitaxel in order to achieve the highest dose of study drug possible that will not cause~     unacceptable side effects. Patients will be followed to see what side effects the~     combination causes and what effectiveness the combination has, if any, in treating the~     cancer. Approximately 36 patients from the US will be enrolled in this study.~   "
107534|NCT01649310|"~     The whole body vibration offers better treatment adherence among the elderly, minimizing~     effort and additional stress to the cardiovascular system and skeletal muscles compared to~     conventional exercise programs.~      Hypothesis: Patients with COPD undergoing a training program on the whole body vibration~     show better performance in the 6MWT and improvement in muscle strength.~   "
107535|NCT01649297|"~     The aim of this study is to investigate the efficacy and safety of two doses (high and low)~     of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus~     (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a~     twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose~     once daily or split vs. low dose once daily or split). This is done to evaluate whether a~     twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once~     daily dosing when given on top of metformin background therapy.~   "
107536|NCT01649284|"~     This is an open-label, multi-center, single-arm trial, designed to provide early access to~     afatinib and to provide additional information on the safety and efficacy of afatinib in~     advanced NSCLC patients who harbor an EGFR mutation.~   "
107537|NCT01649271|"~     The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in~     combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the~     efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2~     overexpressing metastatic breast cancer.~   "
107538|NCT01649258|"~     This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal~     system work in preventing nausea and vomiting in patients with breast cancer undergoing~     chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients~     treated with chemotherapy~   "
107539|NCT01649245|"~     It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant~     interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in~     treatment of Egyptian patients with chronic hepatitis C for 48 weeks.~      hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end~     of treatment, as well as 24 weeks after therapy is completed.~   "
107540|NCT01649232|"~     In the present study the aim is to examine whether transcranial direct-current stimulation~     (tDCS) generated excitability changes and induce modifications of functional cortical~     architecture in Attention Deficit Hyperactivity Disorder (ADHD) patients. To achieve this,~     the investigators used an event-related potential (ERP) analysis based on 20 channel EEG~     recordings in ADHD subjects before and after bipolar tDCS-anode stimulation over F3/F4 or~     T5/T6 or P4/P3, during resting state and measure clinical scores and visual CPT tasks~     changes. Time courses and topography of independent component visual ERPs were compared~     before and after tDCS.~   "
107541|NCT01649219|"~     Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting~     and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom~     impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.~   "
107542|NCT01649206|"~     Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the~     management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for~     patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of~     subjects with TNs (one group to treat with RTA and a matched untreated control group) will~     be evaluated in term of TN volume, thyroid hormones and clinical symptoms.~   "
107543|NCT01649193|"~     The purpose of this study is to determine the important change in the Short Physical~     Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple~     physical test that measures balance and the functioning of the legs. It has been widely used~     in healthy elderly populations and predicts hospital admission and the onset of disability.~     The SPPB has not previously been used in patients with lung disease, and it is not clear~     what change in this test is considered meaningful and worthwhile by patients or doctors (the~     minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow~     researchers and doctors to evaluate the effectiveness of current and new treatments, and to~     detect improvement or deterioration in the condition of patients.~   "
107544|NCT01649180|"~     The purpose of this study is to see how well the study drug, axitinib, helps control renal~     (kidney) cancer that has come back (recurrent) or spread (metastatic). Patients must have~     already been treated as a participant in a clinical trial with sunitinib, sorafenib,~     pazopanib or placebo (sugar pill) after their initial surgery.~      This study will examine the effect of adjuvant tyrosine kinase inhibition (TKI) therapy~     (sorafenib, sunitinib or pazopanib) on subsequent exposure to TKI with axitinib in the~     first-line recurrent or metastatic setting.~   "
107545|NCT01649167|"~     Background: Obesity in pregnancy is increasing and is a risk factor for metabolic pathology~     such as preeclampsia. Leptin is an adipokine which has a direct relationship to obesity.~      Aim: to measure leptin in lean, obese and diabetic pregnant women at three months intervals~     throughout their pregnancies.~      Methods: Pregnant women were recruited in the 1st trimester of pregnancy, and three groups~     were formed: a) with pregestational Body Mass Index (BMI) less than 25 kg/m2, b) BMI higher~     than 25 kg/m2 and c) with Gestational Diabetes Mellitus (GDM). Serum levels of leptin were~     measured with radioimmunoassay (RIA) technique.~   "
107546|NCT01649154|"~     The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery.~     The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative~     blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of~     post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to~     traditional dissection in a prospective randomized trial of total thyroidectomy procedures,~     for benign disease.~   "
138491|NCT01242202|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
107548|NCT01649128|"~     For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators~     established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of~     Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down~     syndrome screening.~   "
107549|NCT01649115|"~     The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles~     Passport Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that~     the participants in the intervention arm will exhibit less excessive weight-for-length gain~     from 4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in~     the intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants~     in the control arm, who receive usual care.~   "
107550|NCT01649102|"~     The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic~     hemodialysis patients. The design of the catheter may affect the propensity for thrombosis~     and hence intraluminal infection, as well the percentage of recirculation and hence the~     efficiency of dialysis.~   "
107551|NCT01649089|"~     This clinical trial studies the physical function and quality-of-life before and after~     surgery in patients with stage I cervical cancer. Studying quality-of-life in patients~     undergoing surgery for cervical cancer may help determine the intermediate-term and~     long-term effects of surgery.~   "
107552|NCT01649063|"~     Dystocia is the most common indication for primary cesarean section. The most common cause~     of dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more~     attention is usually paid on fetus and pelvic rather than on the role of uterine contraction~     in delivery. So we decided to determine the relationship between dystocia and uterine~     contraction patterns.~   "
107553|NCT01649050|"~     To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity~     due to multiple sclerosis~   "
107554|NCT01649037|"~     All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or~     during hospitalization will be included in the study.~      The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory~     tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and~     liver histology, when available.~   "
107555|NCT01649024|"~     The study is designed to define the immunologic and clinical activity of Tremelimumab in~     patients with advanced mesothelioma.~   "
107556|NCT01649011|"~     The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry~     Disability Index (ODI) version in patients with low back pain.~      Internal consistency, reproducibility and reliability will be addressed scoring the results~     of the translated version at two time frames. A previously spanish validated translation of~     the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and~     evaluate both versions.~   "
107557|NCT01648998|"~     Stimulating the mineralocorticoid receptor (MR) may restore a disturbed balance as seen in~     depression. In this double-blind, randomized, placebo-controlled trial the investigators~     will test the effects of a single dose (500mg) fludrocortisone, an MR-agonist, on the~     information processing in healthy female volunteers (N = 2x20).~      The investigators want to investigate whether the acute administration of fludrocortisone~     (FC) in healthy females enhances the appraisal of emotional information related to~     depression, hypothesizing that:~        -  FC relative to placebo selectively improves the recognition of happy and fearful faces:~          resulting in more correct responses and faster RTs.~        -  FC induces a bias towards more positive self-description and an improved memory for~          positive information.~      Female participants were selected because the haplotype MRI180V is related to depression~     vulnerability in women, not in men. If the effects of fludrocortisone are comparable to the~     effects of antidepressants on the same tests and the same population, it might be a first~     indication that fludrocortisone may function as an antidepressant.~   "
107558|NCT01648985|"~     In acute stroke patients about 20 % have known diabetes. There is a doubled risk of~     recurrent stroke in diabetic patients. It has been shown that antiplatelet drugs are not as~     effective in diabetic patients as in non-diabetic patients. In acute stroke patients around~     80 % have impaired glucose tolerance, which will improve after one month till about 60 %.~      This study includes acute patients with minor stroke or TIA. They are followed up at one and~     six months and then at every six months for at least four years. The investigators perform~     an OGTT and haemostatic tests within the first days after onset and then at one month. Blood~     pressure, metabolic parameters, bodyweight, physical activity and diet are collected at each~     visit. The investigators give the patients information about lifestyle changes as needed.~      As part of the study there is an interventional study, Medicine Yoga, an open randomized~     controlled study. Patients are randomized to 16 sessions of Yoga under professional~     instructions and a CD for home training or controls.~      The aims of this study are to investigate glucose tolerance in acute stroke and TIA~     patients, and its relation to the different haemostatic variables. The importance of glucose~     tolerance, haemostatic variables and other risk factors (blood pressure, lipids, BMI,) on~     cardiovascular events will be investigated and the possibility to affect these risk factors~     by lifestyle changes and Yoga. The effect of different antiplatelet drugs will be~     investigated in relation to glucose tolerance.~   "
107559|NCT01648972|"~     After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this~     time patients are often unable to eat and drink, and do not pass any flatus or stool. Though~     this resolves within a few days for most, there are a significant number (around 30%) who go~     on to have a prolonged period of this dysfunction known clinically as postoperative ileus.~     It has been clearly shown that this group of patients have worse health outcomes and spend a~     longer time in hospital.~      The aim of this study is to trial a drug - gastrografin - in the management of prolonged~     postoperative ileus. Gastrografin is safe, economical, readily available, and has been used~     with great success in the similar condition of bowel obstruction. It is predicted that~     gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording~     affected patients a better outcome from surgery.~   "
107560|NCT01648959|"~     Various parts of the brain are sensitive to various anesthetics.We like to study the effect~     of dexmedetomidine on the different parts of the brain in patients who are coming for DBS~     electrode removal under sedation.~   "
111361|NCT01598649|"~     The objective of the study is to elucidate the effects of lupin protein (Lupinus~     angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to~     clarify the role of arginine, one of the most abundant amino acids in lupin protein.~   "
107561|NCT01648946|"~     Blood transfusion in critical ill patients has been associated to several complications and~     worse outcome. Particularly in oncologic patients, red blood cell transfusion has been~     investigated as a factor of worse outcome and cancer recurrence due impairment of cellular~     immunity. Although red blood cell transfusion has decreased in worldwide clinical practice,~     this issue still remains a matter of controversy in oncologic patients. There are no~     prospective studies comparing outcomes between restrictive or liberal blood transfusion~     strategy in oncologic critical patients. This study is a prospective and randomized study~     comparing clinical outcomes between two strategies of transfusion in oncologic critical~     patients - liberal or restrictive.~   "
107562|NCT01648933|"~     The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac~     sarcoidosis.~   "
107563|NCT01648920|"~     Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with~     Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed~     asthma~      Number of participants: Approximately 50 subjects will be enrolled~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: FeNO measurements will be performed according to the Perform FeNO~     Measurement guidelines on page 7 of the NIOX MINO® User Manual. MCC testing will be~     performed according to the ATS guidelines and the allergy and asthma specialists procedure~     for conducting MCC tests~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan from the time that informed consent~     has been provided and during the study period~      Criteria for evaluations: This is an exploratory study and there are currently no plans for~     a formal statistical analysis. Information gained from this study may used to design and~     power subsequent studies in patients with suspected but undiagnosed asthma. Information~     collected will be summarized in a clinical study report~   "
107564|NCT01648907|"~     This study is a large national multicenter, longitudinal, prospective follow-up of patients~     presenting with early inflammatory back pain in order to set up a database to facilitate~     several investigations on diagnosis, prognosis, epidemiology, pathogenesis and~     medico-economics in the field of early inflammatory back pain and spondyloarthritis~   "
107565|NCT01648894|"~     At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to~     planify the surgery. During this visit, the study will be explained them and their consent~     obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients~     were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in~     this study does not change treatment, investigations and consultations usually necessary for~     management of rectal cancer. The objective is to improve the pathological complete response~     rate of the rectal cancer.~   "
107566|NCT01648881|"~     Patients with dissection of the descending aorta will be followed up according to a precise~     timeline.~   "
107567|NCT01648868|"~     In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal~     social cognition. With that purpose, we will measure the effect of inhibitory and excitatory~     rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the~     ability to recognize human voice/sounds.~   "
107568|NCT01648855|"~     Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal~     and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and~     antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of~     preeclampsia. Patients with preeclampsia have a higher circulating concentration of~     antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR-~     1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and~     a lower maternal circulating concentration of free angiogenic factors (ie, vascular~     endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a~     normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm~     birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent~     studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in~     the number of small arteries and on abnormal distribution of vessels within the distal~     lungs. This is associated with reduced lung VEGF expression. The main objective of this~     population-based study, ie in intra uterine growth restricted preterm babies born before 30~     weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and~     umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.~   "
107569|NCT01648842|"~     Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant~     women who will develop preeclampsia in the second or third trimester compare to a control~     group Primary purpose : To determine the vitamin D status in the first trimester in a large~     population of french pregnant women in order to evaluate the importance of the vitamin D~     deficiency in France and correlate this deficiency with preeclampsia~   "
107570|NCT01648829|"~     Levels of platelet reactivity in patients on Dual Antiplatelet Therapy (DAPT) can be~     influenced by concomitant treatment with medications (i.e. statins) that inhibit the CYP3A4~     system involved in the activation of clopidogrel. Atorvastatin and simvastatin are~     metabolized by CYP3A4. Pitavastatin, unlike other statins, is little metabolized, most of~     the dose being excreted unchanged in bile, and biotransformation through the cytochrome P450~     system is minimal. Indeed, pitavastatin's cyclopropyl group diverts the drug away from~     metabolism by CYP3A4 and allows only a small amount of clinically insignificant metabolism~     by CYP2C9.~      The primary objective of this study is to compare the pharmacodynamic effects of a~     CYP3A4-metabolized statin (atorvastatin) versus a non-CYP3A4-metabolized statin~     (pitavastatin) in patients showing high platelet reactivity while on DAPT.~   "
107571|NCT01648816|"~     The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with~     a higher maternal morbidity and mortality, and also with pervasive effects on the emotional,~     cognitive and behavioral development of the infant.~      Stressful life events, socio-demographic and obstetrical risk factors have been associated~     with the risk of PPD. Genetics risk factors of PPD have also been identified. We are~     presently studying for the first time how maternal stressors may interact with genetic~     factors to increase the risk of PPD (Gene x Environment interaction).~   "
112839|NCT01579201|"~     The purpose of this trial is to determine the effective dose of carbetocin which would~     prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective~     cesarean delivery.~   "
107572|NCT01648803|"~     The purpose of this study is to measure motor fluctuations and dyskinesias in patients with~     Parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if~     this is a feasible measure to use in addition to self report, and eventually the goal will~     be to replace self report with a more reliable measure such as movement sensors.~   "
107573|NCT01648790|"~     The purpose of this study is to evaluate the amount of drug available in the body when given~     to healthy participants as two different formulations with or without a meal. In addition,~     this study will evaluate how much of the drug gets into the blood stream and how long the~     body takes to get rid of it. Information about any side effects that may occur will also be~     collected. Each participant will receive a total of five different treatments. Each~     treatment is given by mouth, once a day. The treatment period lasts for five consecutive~     days.~   "
107574|NCT01648777|"~     Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase~     their mortality. While chest physical therapy plays a crucial role to prevent postoperative~     pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical~     therapy. The continuous local anesthetic infusion by multiperforated catheter decreases~     sternum pain. Because of this optimal pain management, early chest physical therapy could be~     more efficient and could contribute to decrease the rate of pneumonia.~      The aim of this study is to test if management of sternotomy pain using continuous local~     anesthetic infusion by multiperforated catheter may contribute to decrease the rate of~     perioperative pneumonia.~   "
107575|NCT01648764|"~     The purpose of this study is to evaluate two different dosing regimens of LY2334737 in~     participants with cancer that is advanced and/or has spread to other parts of the body.~     Information about side effects will be collected.~   "
107576|NCT01648751|"~     This is a randomized controlled trial in which women with symptomatic mild pelvic organ~     prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus~     placebo to see if a combined approach to treatment leads to improvement in clinical~     outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead~     to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker~     data.~   "
107577|NCT01648738|"~     The purpose of this study is to determine whether an intensive 5 days long multidisciplinary~     program (including spa therapy, exercises and patients'education) is more effective~     regarding return to work than usual care in subacute and chronic low back pain for people in~     sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is~     considered~   "
107578|NCT01648725|"~     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what~     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.~      A particular aspect of this study is that induction is provided by a closed-loop system~     which delivers propofol according to bispectral index.~   "
107579|NCT01648712|"~     Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system~     activation. Platelet dysfunction is commonly observed after procedures performed under~     cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and~     bleeding in the postoperative period.~      Coating of the surface has been shown to diminish these effects.Biocompatible surfaces,~     extracorporeal circulation technologies mimic critical characteristics of the vascular~     endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new~     physiologic non heparin coating with different functional aspects was developed as an~     alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer~     Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system~     (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood.~     The aim of this study is to compare the influence of a Balance - coated CPB system in~     pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation~     and hemostatic activation.~   "
107580|NCT01648699|"~     The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release~     Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy~     among participants with cancer pain.~   "
107581|NCT01648686|"~     The purpose of this study is to determine whether the oral alendronate treatment of~     post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental~     extraction.~   "
107582|NCT01648673|"~     The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient~     referral, recruitment and retention rates and overall patient satisfaction in cardiovascular~     rehabilitation programs at the HFHS.~   "
107583|NCT01648660|"~     The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more~     years after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of~     lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density~     (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage~     groups are crossed after LUTEGA 1.~   "
107584|NCT01648647|"~     Copeptin is accepted as a marker of stress. We want to evaluate the preoperative and early~     postoperative copeptin leavens in patients undergoing different aortic valve procedures~   "
107585|NCT01648634|"~     The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the~     development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15~     year-old.~   "
107609|NCT01648231|"~     The purpose of this study is to evaluate the comparative bioavailability of two fixed dose~     combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects~     will receive each of the following three treatments administered in a randomized three-way~     crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg~     losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg~     losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg~     losartan; all three treatments will be administered once orally and in a fasted state.~     Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis~     of amlodipine, losartan and carboxylic acid (this is the primary active losartan~     metabolite). Safety assessments will include measurements of orthostatic vital signs,~     electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.~   "
108312|NCT01638507|"~     The purpose of this post approval study is to conduct a prospective, multicenter evaluation~     of the procedural and clinical outcomes of subjects that are treated with the commercially~     available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.~   "
107586|NCT01648621|"~     Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases~     referred to as comorbidities. Often these patients require health care by a variety of~     health care professionals from services linked to hospitals and in the community.~     Unfortunately, sometimes it may be difficult for these patients to receive appropriate care~     in a timely manner resulting in a trip to the emergency department. As well, patients may~     benefit from education that enables them to recognize early signs indicating they are~     getting sicker and to self-manage their disease. Our study will examine a strategy that~     includes a case manager who will make weekly phone contact with COPD patients with~     comorbidity that present either to the emergency department or are admitted to hospital.~     Weekly contact will focus on teaching patients to recognize worsening symptoms and~     self-management strategies. The case manager will work with patients, caregivers, community~     health care providers and hospital specialists to promote communication and optimize care~     delivery. The investigators will examine the impact of our intervention on the need for~     emergency department visits and hospital admission. The investigators will also examine the~     impact on patients' health related quality of life, number of COPD exacerbations, and~     disease progression.~   "
107587|NCT01648608|"~     Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy~     and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant~     chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At~     the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and~     safety of TAC and Exemestane.~   "
107588|NCT01648595|"~     Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain~     of delivery. It is necessary to be known effect of these drugs on the mother and fetus~     during labor adverse. Therefore, the purpose of this study was determination of effect of~     Fentanyl intravenously on pain severity during the active phase of labor.~   "
107589|NCT01648582|"~     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe~     compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who~     have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM)~     (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended~     by their healthcare providers.~   "
107590|NCT01648569|"~     Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have~     excellent long-term outcomes, some patients experience tumor recurrence, either locally or,~     less frequently, as distant metastases, with some patients dying due to this disease. The~     natural course of PTMC has not always been universally accepted, thus creating controversy~     concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to~     confidently identify PTMCs that would take aggressive courses if left untreated. Treatment~     recommendations range from observation alone to vigorous intervention featuring total~     thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation.~     Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on~     which therapy is the most appropriate. Moreover, the impact of several clinicopathologic~     risk factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in~     diameter may have a better prognosis than patients with tumors 0.5-1 cm in size.~      Most studies evaluating the proper extent of surgery for PTMC have been retrospective in~     design. A prospective, long-term, randomized study in a large number of patients, however,~     may not be feasible owing to the need for an extensive follow-up duration, the costs~     associated with such a study, and, particularly, its ethical constraints. Consequently, it~     is not currently possible to determine the prognosis of patients with PTMC or the proper~     therapeutic approach in these patients. The investigators therefore compared long-term~     outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than~     total thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients~     with PTMC, using propensity-score matching to adjust for the uncontrolled assignment of~     surgical extent in these patients. In addition, the investigators evaluated whether tumor~     size, ≤ 0.5 cm or > 0.5 cm, had a significant impact in determining the extent of surgery in~     patients with PTMC.~   "
107591|NCT01648556|"~     It is about a multicentric study prospective of more than patients' 60 years with a~     thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so~     certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO,~     the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis~     of PTI.~   "
107592|NCT01648543|"~     Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best~     method of lumbar sympathetic ganglion block is not established. The investigators would~     compare two methods of lumbar sympathetic ganglion block. One is modified Reid method~     which's entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is~     angular method which's entry angle is 30 degree from anterior-posterior view of C-arm.~     Comparison modified Reid method with angular method would be helpful for finding best method~     of lumbar sympathetic ganglion block.~   "
107593|NCT01648530|"~     This is a population internet-based study to characterize migraine clinical course and~     impact on family.~   "
107594|NCT01648517|"~     This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC~     using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1~     and RRM1 of the tumor cells.~   "
107595|NCT01648504|"~     The investigators will attempt to improve the patient experience before colonoscopy. The~     investigators will provide an in-office ipad video series and an electronic web guide to~     help patients learn all the best ways to prepare for colonoscopy. The investigators will~     then follow the patients who receive this eGuide to colonoscopy and observe whether or not~     they enjoyed the additional access to information from their providers, and will monitor~     whether or not they were better prepared for their colonoscopy.~   "
107596|NCT01648491|"~     Determine safety and effectiveness of the technique using autologous stem cells in the~     treatment of urinary incontinence in one male subject.~   "
107597|NCT01648478|"~     Previous studies have demonstrated defects in the trafficking and translocation of GLUT4~     glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin~     resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which~     collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin.~     The extracellular domain of IRAP is cleaved and released in the bloodstream.~      Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.~      In this study the investigators seek to confirm this hypothesis by using the gold standard~     of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.~      It is a multicenter descriptive study.~   "
107598|NCT01648465|"~     The purpose of this study is to explore the efficacy and safety of everolimus administered~     as a first-line treatment in newly-diagnosed patients with advanced or inoperable~     Gastrointestinal (GI) or pancreatic neuroendocrine tumors.~   "
140625|NCT01214122|"~     The primary purpose of this study is to determine whether the treatment with AZD9668 will~     affect the metabolism and effect of Warfarin.~   "
107599|NCT01648452|"~     Background:~        -  Achromatopsia is an inherited condition that causes vision loss because cells in the~          retina do not work properly. It causes loss of acuity, sensitivity to light, and loss~          of color vision. There are no effective treatments for achromatopsia.~        -  Four genes currently are known to cause achromatopsia. One of these, the cyclic~          nucleotide-gated channel beta 3 (CNGB3) gene, is the cause in about 50 percent of~          people.~        -  CNTF is a natural chemical found in the body that promotes survival and function of~          nerve cells. CNTF has been shown to be effective in treating retinal disease in animals~          and can slow vision loss.~        -  CNTF has also been studied in over 250 people with retinal disease other than~          achromatopsia. In these studies, a CNTF implant was placed into the eye during a simple~          surgery. The implant releases CNTF inside the eye, near the retina. These studies~          suggested that a CNTF implant might help vision in some eye diseases.~      Objectives:~        -  To learn whether a CNTF implant is safe for people with CNGB3 achromatopsia.~        -  To learn whether CNTF can improve visual acuity or color vision, and whether it may~          reduce sensitivity to light in people with CNGB3 achromatopsia.~      Eligibility:~      You may be able to take part in this study if you:~        -  Are at least 18 years old.~        -  Test positive for mutations in the CNGB3 gene and have no mutations in another~          achromatopsia gene.~        -  Have 20/100 vision or worse in at least one eye.~        -  Are not pregnant or nursing.~      Design:~        -  To determine if you can take part, we will ask about your medical history and do a~          physical examination and an eye examination. Blood and urine samples will be taken.~        -  This study requires 11 visits to the National Eye Institute over 3 years.~        -  One visit will be for the implant surgery. The implant will be placed in one eye only.~        -  Study visits will take place 1 day after implant surgery, and again 1 week later and 1~          month, 3 months, 6 months, 1 year, 1.5 years and 3 years later. These visits will help~          us evaluate the safety and benefit of the implant on your eye.~        -  At the 3 year visit, you can choose to keep the CNTF implant in your eye, or you can~          have us remove it.~   "
107600|NCT01648348|"~     This partially randomized phase I/II trial studies the side effects and the best dose of~     anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how~     well they work in treating patients with glioblastoma multiforme that has come back.~     Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may~     find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105~     together with bevacizumab may be an effective treatment for glioblastoma multiforme.~   "
107601|NCT01648335|"~     Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical~     problem. The majority of the dislocations are anterior (about 95%) while the rest are~     posterior and inferior. After reduction of the initial dislocation, the treatment's goal is~     to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in~     the population aged 18-29. There is an age-related decrease in the recurrence rate, with the~     only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army~     between the ages of 17 and 33 suffers from recurrent shoulder dislocations [1].~      The traditional treatment for primary (first-time) shoulder anterior dislocation has been~     immobilization of the shoulder in internal rotation in a soft dressing called universal~     shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based~     information to demonstrate the effectiveness of this treatment. Posterior dislocations are~     immobilized in external rotation. Work presented previously in the Orthopaedic Research~     Society and more recently at the American Academy of Orthopaedic Surgeons suggests that~     immobilization of the shoulder after reduction of anterior dislocation is best in external~     rotation and not in internal rotation. MRI studies have shown that the labral tear, which is~     the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical~     position when the shoulder is immobilized in external and not in internal rotation.~     Preliminary data indicates that immobilization in external rotation of the primary traumatic~     shoulder dislocations may lower the incidence of reoccurrence.~      The traditional shoulder immobilizer is a generic bandage produced by several companies. In~     the current study, the investigators will use a USI distributed by Uriel® company (Uriel~     #87), which can be modified to hold the shoulder in external rotation.~   "
107602|NCT01648322|"~     This is a randomized open label dose finding study to evaluate the efficacy and safety of~     F-627 on women with Stage II-III breast cancer receiving chemotherapy treatment.~   "
107603|NCT01648309|"~     The purpose of this study is to examine the neuropsychological effects of transvascular~     aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive~     heart failure and low cardiac output which may limit their cognitive abilities. TAVI results~     in significant improvements in cardiac function and therefore may improve cognitive~     functions. However, TAVI may also be associated with stroke and may therefore have a~     negative impact on cognition. Therefore, in this study the investigators wish to perform a~     battery of standardized neuropsychological tests before and after TAVI to test the net~     effects of TAVI on cognitive performance over time.~      The investigators plan to include all patients planned to have TAVI in the study and to test~     them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.~   "
107604|NCT01648296|"~     A single center, open-label baseline controlled imaging study to designed to assess whether~     Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism~     performed with [18F]FluorbetaOx correlates with measurements using [11C]palmitate. This~     study involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled~     fatty acid analog, [18F]FluorbetaOx designed to measure beta oxidation of fatty acids in the~     myocardium. The investigators propose to evaluate the feasibility of the method in heart~     failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2~     diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without~     T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA~     metabolism.~      Specific objectives include:~        1. To assess the diagnostic quality of [18F]FluorbetaOx PET images and kinetics at the~          proposed 10 millicurie (mCi) dose.~        2. To quantitatively determine the relationship between PET measurements of myocardial FA~          metabolism obtained with [18F]FluorbetaOx and those using [11C]Palmitate.~        3. To calculate human dosimetry based on the human biodistribution of [18F]FluorbetaOx.~        4. Correlate measurements of myocardial FA metabolism with changes in left ventricular~          (LV)structure and function performed on a clinically indicated echocardiography at 6-9~          months after imaging.~   "
107605|NCT01648283|"~     This research study will determine if genetic variation in CYP2B6 affects how the body~     metabolizes methadone.~   "
107606|NCT01648270|"~     The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.~   "
107607|NCT01648257|"~     This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods)~     in healthy adult subjects. During each period, subjects will receive a single dose of~     GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours~     (8 days) and safety assessments will be performed. Each period will be separated by a~     washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the~     last dose of study drug.~   "
107608|NCT01648244|"~     The primary purpose of this study is to determine whether the use of CADS by primary care~     providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care~     relative to a usual care group in terms of objective outcome measures of glycemic control~     (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of~     subjective ratings by patients.~   "
107640|NCT01647828|"~     The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose~     (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2,~     multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of~     OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously~     untreated stage IV pancreatic cancer.~   "
107610|NCT01648218|"~     No consensus guidelines exist for management of post-transplant glucocorticoid induced~     hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety~     of insulin regimens have been proposed, including mealtime short-acting regular or analog~     insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal~     insulin alone such as glargine or detemir. However, no randomized trial has ever examined~     different insulin regimens to determine which most effectively controls post-transplant~     steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three~     commonly used insulin regimens used for managing post-transplant once-daily~     glucocorticoid-induced hyperglycemia to determine which is most effective:~        -  Group 1: Intermediate-acting (NPH) insulin at breakfast~        -  Group 2: Short-acting insulin (regular or aspart) before meals~        -  Group 3: Insulin glargine at breakfast~      Question/Hypothesis:~      Among three commonly used insulin regimens, which is most effective for managing~     post-transplant once-daily glucocorticoid-induced hyperglycemia?~   "
107611|NCT01648205|"~     The purpose of this study is to determine whether late sodium channel blockade might be~     effective in shortening the QTc interval in various LQT3 mutations and be considered as a~     safe therapeutic option for LQT3 patients.~   "
107612|NCT01648192|"~     This study is the first study of losmapimod in Japanese subjects. This study will be a~     single-center, single blind, phase I and two part study to characterize the safety,~     tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers~     (male and female of non-childbearing potential). Part1 will be a single dose, randomized,~     three-period, placebo-controlled and dose escalation part. Each subject will participate in~     3 dosing sessions, and receive, on separate days, three of four treatments of losmapimod~     2.5, 7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at~     least 10 hours). The design incorporates sufficient washout between treatments (at least 7~     days after the previous administration), and is an efficient design for the study~     objectives. Part 2 will be a fixed dose and placebo-controlled part. Each subject will~     participate in one dosing session, and receive losmapimod 7.5 mg or the matching placebo~     twice daily in the fasted state for 14 days. Only subjects will be blind to the sequence and~     dose studied. The study will include the placebo treatment to allow a valid evaluation of~     adverse events attributable to treatment versus those independent of treatment.~     Approximately 18 subjects in each part will receive treatments of losmapimod and/or placebo~     in the design. The primary objective of the study is to characterize the safety and~     tolerability of single doses and repeat doses of losmapimod in healthy Japanese subjects.~     Serial pharmacokinetic samples will be collected and safety assessments will be performed~     following each dose.~   "
107613|NCT01648179|"~     This study is an open-label, randomized, single dose, four period, balanced crossover study~     to assess in eligible healthy male or female subjects.~   "
107614|NCT01648166|"~     This is a research study about the relationship between lung cancer and environmental risk~     factors. The purpose of this study is to try to understand the effects of trace elements~     such as arsenic and chromium, as well as radon on the development of lung cancer. To do~     this, the investigators will collect information and environmental and biologic specimens~     from people who live in Appalachian Kentucky who a) have lung cancer or b) don't have lung~     cancer and will serve as control subjects. The investigators will create a specimen~     repository of from these people and their residences to compare differences in many risks~     factors for cancer. By doing this study, the investigators hope to learn why there are more~     lung cancers in Kentucky's fifth Congressional District than anywhere else in the nation.~   "
107615|NCT01648153|"~     GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine~     interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the~     efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese~     subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the~     mechanism by which GSK1070806 exerts its therapeutic effects.~   "
107616|NCT01648140|"~     GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being~     developed for the treatment of chronic HCV infection. This Phase II, multicenter,~     parallel-group, randomized, dose-ranging study will assess the safety and tolerability,~     antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in~     combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately~     100 treatment-naïve subjects with chronic genotype 1 HCV infection.~      In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with~     genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of~     GSK2336805.~   "
107617|NCT01648127|"~     The purpose of this study is to characterize plasma and urinary concentrations of~     ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in~     healthy subjects who are normal weight, overweight, and obese.~   "
107618|NCT01648114|"~     The investigators will conduct an educational intervention for pregnant women who are~     planning to breastfeed to promote exclusive breastfeeding and to increase the duration of~     breastfeeding.~   "
107619|NCT01648101|"~     The immediate release (IR) formulation of retigabine has been shown to be superior to~     placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with~     drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or~     more antiepileptic drugs (AEDs) and were still having seizures despite current treatment~     with 1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3~     clinical studies, only 10 were Asian subjects and only 5 of these Asian subjects were~     randomly assigned to treatment with retigabine. Therefore, this Phase III study is being~     conducted to evaluate the efficacy, safety and tolerability, and health outcomes of~     retigabine, at doses of 900 mg/day and 600 mg/day, compared with placebo in adult Asian~     subjects with drug-resistant POS.~   "
107641|NCT01647815|"~     The main objective of this study is the demonstration of an increase of over 50% of the~     surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm~     abduction (90 °) and external rotation (90 °) with respect to the surface of the subclavian~     vein along the arm body.~   "
107642|NCT01647802|"~     The main objective of this study is to evaluate via a physiological analysis of the~     movements involved in standing, the level of forward flexion of the spine (in cm on the~     horizontal axis) obtained with the apparatus Tina and to compare levels obtained in the~     same patients with stander/transfer devices Turner and Vertic'Easy.~   "
107620|NCT01648088|"~     The presence of Staph in/on a patient who will undergo total joint replacement is a risk in~     that the patient could go on to develop infection at the surgery site after surgery. The~     purpose of this study is to evaluate if it is beneficial to to administer a questionnaire~     and obtain cultures from various body sites from patients prior to surgery and also to~     determine which body site(s) provide the best source of possible staph presence. If the pre~     operative cultures indicate staph is present, an Infectious Disease specialist will be~     consulted for standard of medical care consultation and treatment management. All patients~     scheduled to have total joint arthroplasty are eligible to participate. The research team~     will follow the study patients for 2 years after they undergo prosthetic joint implantation~     to monitor for development of prosthetic joint infection.~   "
107621|NCT01648075|"~     Probiotics are microorganisms that when administered in adequate amounts can confer health~     benefits. In vitro and clinical studies support the idea that lactobacilli have protective~     effects on oral health. A recent study in which preschoolers consumed milk drinks enriched~     with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits~     to children.~      The aim of this study is to evaluate the effect of daily consumption of milk beverages~     enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean~     children.~   "
107622|NCT01648062|"~     This randomised controlled trial assessed the efficacy of four mental imagery techniques for~     improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels;~     (2) imagery incorporating implementation intentions (a strategy designed to link specified~     behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of~     imagery using arousal reduction and implementation intention strategies; or (4) a condition~     where participants were asked to imagine their typical post work activities.~   "
107623|NCT01648049|"~     Insomnia and depression are two of the most prevalent mental health disorders and often~     co-occur.~      Health disparities in rural America and among African-Americans are well documented. The~     investigators propose an R34 exploratory project to test the feasibility of delivering~     high-fidelity insomnia and depression psychological services to an underserved population.~     Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat~     rural, predominantly African-American older adults who present to their primary care~     physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study~     series (n = 10) focusing on treatment development/refinement and patient acceptability. In~     stage 2, feasibility will be experimentally tested with 46 participants randomized to~     integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an~     effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia~     (including relaxation, sleep restriction, and stimulus control) and for depression~     (including cognitive therapy and behavioral activation). The experimental intervention~     comprises delivering CBT services by videoconferencing to patients in primary care settings~     who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report~     instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot~     will use investigator designed quantitative and qualitative measures to evaluate critical~     process variables including patient acceptability of the video format, patient acceptability~     of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may~     be incorporated into stage 2 as well. Several innovative features of this exploratory~     project include: intervening with CBT on both disorders hoping to gain a synergy by their~     combined presentation; use of telehealth to deliver treatment to distant locations;~     translation of efficacy findings to an effectiveness trial; treatment will be delivered in~     the primary care setting, the preferred locale of rural, older adults; the study will extend~     knowledge of the range of CBT applications by enrolling under-represented groups with~     respect to ethnicity, literacy, and financial resources.~      The primary aims of this project are (1) to determine the feasibility and maximal therapy~     characteristics of integrated CBT for co-occurring insomnia/depression in both the case~     study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data~     on whether participants receiving integrated CBT + usual care show comparable or greater~     reductions in insomnia symptoms compared to participants receiving usual care at~     posttreatment and follow-up, and (3) collect pilot data on whether participants receiving~     integrated CBT + usual care show comparable or greater reductions in depression symptoms~     compared to participants receiving usual care at posttreatment and follow-up.~   "
107624|NCT01648036|"~     Life-threatening infections account for 10% of all intensive care unit admissions and~     constitute the second more frequent cause of death in the ICU after heart diseases. The most~     common cause of death in patients admitted with life-threatening infections is multi-organ~     failure that is mediated by severe inflammation. Given the relationship between inflammation~     and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease~     inflammation and the formation of small clots. Several lines of evidence suggest that~     heparin, a proven and inexpensive blood-thinner, may reduce improve survival in patients~     diagnosed with life-threatening infection. The primary objective of this study is to~     demonstrate the feasibility of enrolling patients in a large randomized controlled trial~     investigating heparin in patients with severe infections. In this study, patients with~     life-threatening infections will have an equal chance of receiving an intravenous infusion~     of heparin, or a low dose of a similar drug to prevent of blood clots while patients are~     immobile. The primary purpose of the study is to demonstrate that an average of 2 patients~     per site, per month, can be enrolled. Other measures of feasibility include the consent~     rate, the number of protocol violations that occur during the trial, and the number of dose~     reductions needed due to excessive anticoagulation. To study the biologic effects of heparin~     in patients with severe infection, specific laboratory markers will be measured and~     analyzed. If the feasibility of the trial is confirmed, a large randomized trial designed to~     tell if heparin can safely improve survival will be conducted. Given its low cost and~     availability, if heparin is shown to improve survival in patients with severe infection,~     adoption of this therapy on a global scale is anticipated.~   "
107625|NCT01648023|"~     The purpose of this study is to find out if the combination of trans-arterial~     chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more~     effective than just receiving the infusional chemotherapy alone.~   "
107626|NCT01648010|"~     The purpose of this study is to evaluate the safety of intravesical instillation of TC-3~     Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary~     bladder.~   "
107643|NCT01647789|"~     This study will assess the safety and preliminary antitumor activity of CFG920, a new CYP17~     inhibitor in castration resistant prostate cancer patients who are abiraterone naive or~     abiraterone resistant.~   "
107644|NCT01647776|"~     The investigators propose a screening population-based study to systematically evaluate the~     accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy~     screening. In addition, the investigators propose a genetic epidemiologic study of the~     relation between colon polyps, an established precursor of colon cancer, and two factors~     that may influence risk for colon cancer: candidate genes and diet.~   "
107676|NCT01647360|"~     Dydrogesterone is a retroprogesterone with a molecular structure similar to natural~     progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low~     antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or~     androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.~      In this study, women suffering from menorrhagia and who are treated with dydrogesterone will~     be observed for impact on QoL with the reduction in severity of bleeding.~   "
107627|NCT01647997|"~     Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with~     sepsis severity. The pathophysiological mechanisms (increased lactate production vs~     decreased lactate utilization; tissues involved in sepsis-induced lactate production) remain~     largely unknown.~      In this study, the investigators will assess whole body and regional metabolism in healthy~     young male subjects on two occasions, once after administration of an intravenous bacterial~     endotoxin challenge, and once without intervention.~      In one group of subjects, whole body lactate metabolism will be measured over 10 hours after~     the endotoxin challenge~        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)~        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)~        -  Glucose kinetics (measured with 6,6 d2 glucose)~        -  Hemodynamic parameters and body temperature~        -  Blood clinical chemistry In one group of subjects, whole body lactate metabolism will~          be measured over 10 hours after the endotoxin challenge~        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)~        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)~        -  Glucose kinetics (measured with 6,6 d2 glucose)~        -  Hemodynamic parameters and body temperature~        -  Blood clinical chemistry~      In a second group of subjects, regional muscle lactate metabolism will be measured over 10~     hours after the endotoxin challenge by means of muscle microdialysis~   "
107628|NCT01647984|"~     Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign~     supraventricular and ventricular extrasystoles in subjects free of a specific organic heart~     disease. It has been suggested treatment with a nutritional supplement, able to normalize~     the 'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination~     of nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and~     Vitamin E, help to normalize the heart pacing, reducing the total number of benign~     extrasystoles and consequently improving the quality of life.~   "
107629|NCT01647971|"~     The purpose of this study is to determine whether ublituximab is safe and effective in~     patients with relapsed or refractory B-cell lymphoma who were previously treated with~     rituximab.~   "
107630|NCT01647958|"~     The purpose of this study is to assess the efficacy and safety of Transoral Incisionless~     Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI)~     therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with~     refractory symptoms on Proton Pump Inhibitors (PPIs).~   "
107631|NCT01647945|"~     Mutations in bone morphogenetic protein receptor 2 (BMPR2) are present in >80% of familial~     and ~20% of sporadic pulmonary arterial hypertension (PAH) patients. Furthermore~     dysfunctional BMP signaling is a general feature of pulmonary hypertension even in~     non-familial PAH.~      We therefore hypothesized that increasing BMP signaling might prevent and reverse the~     disease. We screened > 3500 FDA approved drugs for their propensity to increase BMP~     signaling and found FK506 (Tacrolimus) to be a strong activator of BMP signaling. Tacrolimus~     restored normal function of pulmonary artery endothelial cells, prevented and reversed~     experimental PAH in mice and rats.~      Given that Tacrolimus is already FDA approved with a known side-effect profile, it is an~     ideal candidate drug to use in patients with pulmonary arterial hypertension.~      The aims of our trial are:~        1. Establish the Safety of FK506 in patients with PAH.~        2. Evaluate the Efficacy of FK506 in PAH~        3. Identify ideal candidates for future FK506 phase III clinical trial.~   "
107632|NCT01647932|"~     The purpose of this study is to determine whether a combined diuretic therapy (loop~     diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid~     overload symptoms) among patients with decompensated heart failure in comparison with loop~     diuretic alone.~   "
107633|NCT01647919|"~     The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory~     performance (executive function, associative, spatial and verbal memory) as well as on mood~     and attention parameters after four, eight and eleven weeks of supplementation and in~     comparison with placebo.~      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators~     do not claim that this supplement is meant to treat any ailment.~   "
107634|NCT01647906|"~     The purpose of this observational study is to evaluate the safety and effectiveness of the~     Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a~     real world setting.~   "
107635|NCT01647893|"~     A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose~     Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001~     Intravenously Administered in Healthy Male Subjects~   "
107636|NCT01647880|"~     In the MOVING study should be examined, whether early therapeutic intervention with~     fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a~     comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual~     evoked potentials (mVEP) after 6 month compared to baseline.~   "
107637|NCT01647867|"~     Our project, established through collaboration between clinicians (Oscar Lambret~     Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met~     fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ~     hybridization or immunohistochemistry, the investigators propose a protein analysis by~     Western blot of tumor samples and healthy tissue. This approach will evaluate the expression~     of full-length receptor, the potential presence of intracellular fragments, and their~     phosphorylation status.~   "
107638|NCT01647854|"~     The aim of the study is to investigate the safety and efficacy of the operation of a~     prehospital teleconsultation system in the Emergency Medical Service.~   "
107639|NCT01647841|"~     The purpose of this study is to understand how differences in the nutritional status and~     concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant~     women living in a semi-rural and rural region of northern Tanzania affect fetal growth,~     pregnancy outcomes and early infant health and development. The study hypothesis is that~     HIV+ women will have worse nutritional status and a greater degree of cachexia which will~     negatively impact fetal growth, pregnancy outcomes and early infancy health and development.~   "
108328|NCT01638299|"~     Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize~     hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research~     setting.~   "
107645|NCT01647763|"~     Background:~      Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive~     procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with~     less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled~     hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes~     less post operative pain than stapled hemorrhoidopexy, however the former has a higher~     recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce~     the recurrence rate without increasing the post operative pain.~      Hypothesis and aim:~      The study tries to prove the assumption that combined hemorrhoidal artery ligation and~     rectoanal repair cause less pain and have less post operative complications than stapled~     hemorrhoidopexy.~   "
107646|NCT01647750|"~     All patients with hypothyroidism are currently treated the same way, regardless of age. The~     investigators want to look at whether people aged 80 years or older would benefit from being~     treated with lower doses of levothyroxine. There are three reasons why the investigators~     think this could be beneficial, but this is not yet proven:~        1. Some older people with hypothyroidism may have few symptoms.~        2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood~          to decide the dose of Thyroxine received. The standard normal TSH range used to~          determine the dose of levothyroxine is from younger people. The investigators wonder~          whether this is appropriate to all age ranges particularly as the investigators know~          that older people may normally have higher TSH values.~        3. If TSH levels are too low there may be a slight increased risk of problems such as~          brittle bones or an irregular heartbeat.~      The best way to test whether older people benefit from lower doses of levothyroxine is by a~     large clinical trial. Before the investigators can do this, the investigators need to run a~     smaller clinical trial called a pilot study (SORTED 1) to examine whether this is~     practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism~     aged 80 or above.~      Participants will be randomly allocated to receive their routine or lower dose of~     levothyroxine. Follow-up will be conducted over approximately 25 weeks.~      The investigators also propose a qualitative study (SORTED 2) to specifically understand~     patient's willingness to take part in a RCT and participant's experience of the~     intervention.~      Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid~     patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of~     studying outcomes after 4 years. The cohort study will collect data required to inform a~     sample size calculation for a future full study where the primary outcome will be 4 year~     mortality.~   "
107647|NCT01647737|"~     The goal of this proposal is to investigate the effectiveness of a Medical College of~     Georgia patent pending formulation of natural plant extracts on patients with xerostomia.~     The major component of this formulation is green tea extract with a defined composition of~     polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess~     beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little~     evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B~     lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major~     phytochemicals found in green tea extract, having properties consistent with effects on~     cells of tissues that would be protective towards local inflammation.~   "
107648|NCT01647724|"~     The opportunity of a home, self-collected sample, opens the chance to remove some of the~     barriers that may discourage women from participating to screening programmes or performing~     HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as~     compared with tests performed at a clinic. It allows for privacy, reduces discomfort and~     women know nobody would have to handle their body.~      Study hypothesis: The use of a self-sampler may increase the recovery of non-responders~     women at cervical cancer screening.~   "
107649|NCT01647711|"~     This trial is divided into Part A and Part B. The primary objective of Part A is to~     establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary~     objective of Part B is to assess the response rate of patients with non-small cell lung~     cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A.~      The secondary objective is to explore tumor response and tumor-derived biological markers of~     response to afatinib, as well as pharmacokinetic parameters of afatinib.~   "
107650|NCT01647698|"~     This project will investigate the feasibility and preliminary effectiveness of an intensive~     and focused working memory training program for patients in the early stages of PD receiving~     dopaminergic therapy. The investigators hypothesize that working memory training will be an~     effective method of improving working memory and related cognitive and behavioural functions~     in PD patients.~   "
107651|NCT01647685|"~     A promising strategy to reduce CVD is to directly target inflammation at the level of the~     vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line~     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of~     the strategies to limit systemic immunosuppression is to strive for local delivery and~     prolonged efficacy and low systemic burden of the drug by encapsulating the compound in~     liposomes.~      Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher~     extent at desired areas of interest. Thus, local delivery and prolonged efficacy can be very~     important tools to overcome the potential drawback anti-inflammatory drugs; namely an~     inappropriate immune suppression. In the present project, the investigators therefore aim to~     evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in~     patients with peripheral artery disease due to atherosclerosis. Because these patients will~     undergo an endarteriectomy the investigators will be able to collect atherosclerotic~     material after drug administration and thus evaluate the local delivery and compare the~     effects of Nanocort to Prednison or Placebo.~   "
107652|NCT01647672|"~     Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them~     with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as~     neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of~     Albumin-bound Paclitaxel.~   "
107674|NCT01647386|"~     Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest~     among surgeons to quantify the effectiveness of specific implant designs, the goal of the~     current project is to use Radiostereometric Analysis (RSA) to provide conclusive and~     clinically relevant results on fixation of the tibial component with the DePuy M.B.T.~     Revision TKA system using Metaphyseal Sleeves.~      Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to~     the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The~     maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System~     component between postoperative years one and two does not exceed 0.2 mm indicating adequate~     long-term fixation at the bone-implant interface.~      • Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System~     component between postoperative years one and two does exceed 0.2 mm indicating inadequate~     long-term fixation at the bone-implant interface.~      b) In what proportion of patients is adequate fixation achieved?~   "
107653|NCT01647659|"~     The purpose of this open-label, randomized, 2-treatment, 2-period crossover study with~     incomplete washout is to evaluate the relative bioavailability of 2mg GSK1120212 pediatric~     oral solution formulation in comparison to 2mg GSK1120212 tablet formulation, to investigate~     the safety and tolerability of a single dose of the GSK1120212 pediatric oral solution~     formulation as compared to a single dose of the GSK1120212 tablet formulation, and to~     investigate the palatability of the GSK1120212 pediatric oral solution formulation.~      Subjects will be assigned to one of two possible treatment sequences according to the~     randomization code provided to the sites by GSK: a single dose of 2mg GSK1120212 pediatric~     oral solution formulation then a single dose of 2mg GSK1120212 tablet formulation, or a~     single dose of 2mg GSK1120212 tablet formulation, then a single dose of 2mg GSK1120212~     pediatric oral solution formulation. Administration of GSK1120212 in either sequence will be~     followed by 7 days of serial blood sampling for pharmacokinetic analysis of plasma~     GSK1120212. Safety assessments, including assessment of adverse events, clinical laboratory~     values (hematology, clinical chemistry and urinalysis) and vital signs, will be made~     throughout the study. After completing the pharmacokinetic assessments for two periods,~     eligible subjects may transition to MEK114375, an open-label rollover study of GSK1120212.~   "
107654|NCT01647646|"~     In real life, the investigators will be using different strategies including SMART therapy~     or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma~     control.~   "
107655|NCT01647633|"~     Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a~     runny nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to~     improve these symptoms without side effects common to over the counter and prescription~     medication. It is hypothesized that Calcium Glycerophosphate will have a perceived~     improvement in breathing comfort.~   "
107656|NCT01647620|"~     A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the~     effect of this drug on blood clotting parameters. Furthermore the relation between the blood~     concentrations and the blood clotting effect will be investigated. Safety will be~     investigated as well. The objective of these investigations is to determine the optimal dose~     of DPOC-4088 that, achieves a relevant increase in a specific blood clotting parameter (the~     ecarin clotting time) without safety concerns.~   "
107657|NCT01647607|"~     The purpose of this study is to address gaps in care of young women with breast cancer by~     determining whether educational interventions focusing on issues unique to young women with~     breast cancer and healthy lifestyles for women with breast cancer help to improve care of~     young breast cancer patients. The investigators believe that if addressed early in a young~     woman's care, concerns related to fertility, body image, sexual dysfunction, and physical~     activity will improve the satisfaction with care and quality of life of this vulnerable~     population. The research will be conducted by exporting refined, previously piloted~     educational interventions to 14 academic sites and 40 community medical clinics. The~     investigators will compare how interaction with each intervention affects patients' quality~     of life and satisfaction with quality of care.~   "
107658|NCT01647594|"~     This is a pilot study, which will inform a larger study to evaluate the Young Women's~     Intervention (YWI). The goal of this research is to develop, implement and test a refined~     exportable and sustainable education and support intervention for young women with breast~     cancer and their oncology providers. This pilot study will test the feasibility of the Young~     Women's Intervention (YWI) as well as a Physical Activity Intervention (PAI) at four unique~     sites. In addition, it will include a qualitative assessment, through focus groups and key~     informant interviews, of concerns facing young women with breast cancer. The investigators~     aim to use the findings from this pilot study to inform a larger future Young Women's~     Intervention (YWI) study where the YWI intervention will be compared to a Physical Activity~     Intervention (PAI).~   "
107659|NCT01647581|"~     A randomized trial aimed at determining whether or not hemoclips are effective in preventing~     post-polypectomy bleeds on polyps that are 10mm in size or greater.~   "
107660|NCT01647568|"~     At our VA hospital, in general, it is the policy of our GI lab to not stop our patients~     anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we~     believe the risk of stopping these sort of medications outweigh the risks of a complication~     from a colonoscopy.~      Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on~     any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We~     perform the procedure just like we normally would and then follow-up with the patient 7 and~     30 days after their procedure.~   "
107661|NCT01647555|"~     This study evaluates the skin toxicities in patients with epidermoid cancer, treated by~     Radiotherapy in association with Cetuximab.~   "
107662|NCT01647542|"~     The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific~     adults with type 2 diabetes mellitus (T2DM).~   "
107663|NCT01647529|"~     Objective of this study is to investigate the intracameral level of ganciclovir following~     topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior~     uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment~     infection, either uveitis or endothelitis, who have a positive aqueous real time PCR~     (RT-PCR) and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir~     treatment in the past 1 month, will be recruited in the study after taking an informed~     consent. with active CMV anterior segment infection confirmed by a positive aqueous real~     time PCR (RT-PCR) and have not had any form of ganciclovir treatment in the past 1 month~     were recruited in the study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for~     6 weeks. Following 6 weeks of treatment, tears and aqueous samples will be collected.~     Aqueous will be sent for RT-PCR for CMV status. Ganciclovir drug level in both tears and~     aqueous will be measured by HPLC method. Clinically, degree of the intraocular inflammation,~     Intraocular pressure (IOP) and central corneal thickness (CCT) will be recorded at baseline~     and post-treatment.~   "
107664|NCT01647516|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     ulcerative colitis (UC).~   "
107677|NCT01647347|"~     The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to~     ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in~     terms of post treatment bacteraemia.~      Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.~   "
107665|NCT01647503|"~     Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major~     clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased~     parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion~     are characteristic findings. The most common cause of PHPT is adenoma followed by~     hyperplasia and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are~     partially known. Few genes have been identified and their roles are under study.~      The genes which are under study by different groups are unable to give a definite direction~     towards the understanding of parathyroid tumorigenesis and the mechanism involved in~     overgrowth of parathyroid tissue. So identifying different proteins and their regulation~     pattern from adenomas to carcinomas will be the initial steps towards understanding the~     proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one~     can generate protein level information. In this study, using a combined approach based on 2~     D gel electrophoresis and mass spectrometry (MS), the investigators propose to study a~     comparative proteomics to examine the changes of protein profiles in parathyroid tumor~     tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to~     understand differentially expressed proteins in patients with PHPT. This will help in~     understanding the disease and identifying better diagnostic and curative measures of the~     disease. The investigators are also planning to access nuclear morphometry changes in~     sporadic parathyroid tumors. It will help in establishing cellular and nuclear change~     pattern variations from normal to parathyroid tumors.~   "
107666|NCT01647490|"~     This study is a long-term, prospective, and controlled evaluation of the mechanical~     dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and~     stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an~     alternative pacing site through measures of dyssynchrony in acute and chronic.~   "
107667|NCT01647477|"~     This study aims to determine the impact of sociocognitive and emotional factors on the time~     of the initial consult~   "
107668|NCT01647464|"~     Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study~     is to determine whether there is retention of ultrasound contrast agents in the renal~     microcirculation, which has been described in mice.~   "
107669|NCT01647451|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease~     activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared~     to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate~     (MTX) therapy.~   "
107670|NCT01647438|"~     Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the~     feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle~     intervention to improve the cardiovascular health of underserved South Asian (Indian,~     Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will~     be randomly assigned to either a group to receive heart disease prevention classes or to~     another group where they will receive written materials about heart disease prevention.~   "
107671|NCT01647425|"~     This is an multicenter study for preventive and therapeutic strategies for patients with~     head and neck cancer~   "
107672|NCT01647412|"~     Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately~     20-30% develop this condition during childhood or adolescence, most of whom have Crohn's~     disease (CD). It appears that some individuals are genetically susceptible to certain~     nutrients, causing inflammation and disturbance of their immune system, as well as~     disruption of the intestinal barrier. This leads to malnutrition and inhibited growth, with~     many patients experiencing intense abdominal pain and diarrhea.~      Most physicians treat the disease with drugs that suppress the immune system and decrease~     the inflammatory process. Although these drugs frequently induce remission, most patients~     experience a subsequent return of symptoms and fail to catch up on their growth.~     Additionally, serious side effects are associated with these drugs.~      Individuals genetically prone to CD are believed to have a leaky gut that allows substances~     to pass through the intestinal wall and react with the underlying immune system.~     Furthermore, those nutrients that are toxic to these individuals pass through the decreased~     intestinal barrier triggering an extreme immune response. Nutrients that have been~     implicated include grains, except rice, dairy products, and any food containing carrageenan.~     Excluding these nutrients from the diet has been shown to beneficial for CD patients.~     Certain nutraceuticals, such as curcumin and omega-3 fatty acids, have been shown to provide~     anti-inflammatory effects in IBD patients. In addition, the administration growth hormone~     (GH), has been shown to alleviate symptoms, by enhancing the repair of the intestinal~     epithelium, preventing toxic antigens from reaching the underlying lamina propria.~      Previous studies and case reports provide incomplete evidence that exclusion diet with~     nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD,~     discontinuation of other CD drugs, and catch up growth. This study is designed to test this~     hypothesis. Patients in the treatment group will be treated with DNT and GH, while~     continuing to receive medications from their physician while the control group will receive~     DNT, placebo injections instead of GH. We predict that the treatment group will show greater~     improvement than the control group.~   "
107673|NCT01647399|"~     Asthma has become considerably more prevalent and severe in the U.S. during the last 40~     years, particularly affecting youth in urban areas, yet the reasons for this are not clear.~     There is increasing evidence that vitamin D insufficiency contributes to more severe asthma~     through increased risk of respiratory infections and decreased sensitivity to~     glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous~     glucocorticoids and increased asthma severity. Particularly relevant to health disparities,~     we showed a strong association between vitamin D insufficiency and asthma in urban African~     American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D~     levels than non-AA participants.~      Because AA youth residing in urban Washington, DC have markedly worse asthma than other~     racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and~     emergency department utilization rates up to 5 times the national rates and nearly 10 times~     the Healthy People 2010 target rate), we will utilize our access to this population at the~     extreme of asthma disparities to examine the contribution of vitamin D to disparities in the~     chronic control and acute severity of asthma. The overall goal of this study is to provide~     critical epidemiological/molecular information that will inform the interpretation of~     ongoing and impending randomized clinical trials of vitamin D supplementation in asthma,~     especially with regard to urban AA youth with asthma. We hypothesize that low serum~     25-hydroxyvitamin D [25(OH)D] levels are associated with poor chronic asthma control, worse~     acute asthma severity, and glucocorticoid insensitivity. The knowledge generated by the~     experiments in this application will be crucial to translation of this inexpensive,~     easily-accessible, and thereby potentially disparity-reducing prospective therapy for~     asthma.~   "
107675|NCT01647373|"~     All existing medical literatue regarding axial length (AL) changes after scleral buckling~     surgery for retinal detachment, descibes changes after solid silicone buckling. In this~     hospital, the investigators use only silicone sponge buckling, which has different~     properties and a different buckle profile. there are no studies in the literature describing~     tha AL changes after sponge buckling, or whether the AL change is less or more than with~     solid silicone buckles. The investigators wish to determine whether the AL change profile~     with their silicone sponge is significantly different, and if so, whether this is clinically~     important in determining the better choice of buckle material to be preferred.~   "
107724|NCT01646450|"~     A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as~     first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC~     and mutated EGFR.~   "
107678|NCT01647334|"~     This study aims to use a type of radiation (adaptive radiotherapy) to deliver~     curative-intent treatment to patients with non-small cell lung cancer, whose tumors would~     otherwise be too large for standard curative treatment. The study will use adaptive~     radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment~     plans are modified during the course of treatment due to patient and tumor variations (ie.~     weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side~     effects.~   "
107679|NCT01647321|"~     Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for~     which there are no existing therapies that alter the disease course. This research will~     utilize cutting edge functional electrical stimulation (FES) cycling technology with the~     goal of improving walking in individuals with SPMS. The investigators hypothesize that FES~     cycling will improve walking in subjects with SPMS.~   "
107680|NCT01647308|"~     The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride~     Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with~     metformin.~   "
107681|NCT01647295|"~     The primary objective of this work will first to characterize in typical childhood, visual~     exploratory behavior and pupillary response associated with salience of human social stimuli~     (faces and body movements), and then to evaluate these markers in children with autism.~      The second objective of this work will be to achieve in a population of children with autism~     a longitudinal evaluation of these markers during development and therapeutics.~   "
107682|NCT01647282|"~     The purpose of this study is to determine the effect of local application of minocycline~     microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed~     with moderate-severe chronic periodontitis within a periodontal maintenance program.~   "
107683|NCT01647269|"~     The purpose of this study is to investigate whether deep brain stimulation (DBS) of the~     globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS)~     and whether this treatment has any influence on social, psychological and behavioral~     disability and quality of life.~   "
107684|NCT01647256|"~     The primary purpose of this study is to evaluate if eating a high fat meal versus not eating~     any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second~     purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.~   "
107685|NCT01647243|"~     The purpose of this study is to investigate if preoperative strength training will result in~     faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).~   "
107686|NCT01647230|"~     The aim of this study is to observe how the hemodynamic changes induced by spinal blockade~     affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent~     during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia~     affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia~     could decline cognitive function. In this way a non invasive monitoring technique as~     cerebral oximetry is useful for the safety of anesthetic procedure.~   "
107687|NCT01647217|"~     This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol~     (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis~     (reducing ocular demodex counts and achieving the clinical improvement with minimal or no~     irritation).~   "
107688|NCT01647204|"~     The primary objective of the study is to determine if the use of volunteers employed~     specifically to focus on mealtime assistance can increase food and nutrient intake of~     patients admitted to an acute Care of the Elderly ward. The sustainability of providing~     helpers to increase dietary intake over a year will be assessed and linked to actual dietary~     intake. The secondary objectives are to assess the association between dietary intake~     resulting from mealtime assistance and patient satisfaction, malnutrition risk, body~     composition, grip strength, length of hospital stay and hospital mortality.~   "
107689|NCT01647191|"~     The proposed study will investigate the knowledge level, attitudes, and perceptions among~     staff of Methadone Maintenance Treatment (MMT) clinics and intravenous drug users (IDUs) who~     attending MMT clinics, which is the most reachable population for HCV/HIV intervention in~     China. This study will also explore the barriers that prevent IDUs from getting HCV/HIV~     intervention/prevention and medical care services. This study will help to understand and~     address this important problem in China and other Asian countries.~   "
107690|NCT01647178|"~     The proposed trial is to evaluate the use of the TORQ closure assistance device and how it~     affects pain in the sternum, breathing and quality of life compared to traditional use of~     needle drivers or similar to close sternal wires.~   "
107691|NCT01647165|"~     Background: Bortezomib is a drug approved by the Food and Drug Administration (FDA) to treat~     patients with multiple myeloma. It is given by intravenous injection. Lenalidomide is a drug~     that alters the immune system. It may also help suppress tumor growth. It is approved by the~     FDA to treat some types of blood cancers. Dexamethasone prevents or treats inflammation. It~     is sometimes used to treat multiple myeloma.~      Objectives: The purpose of this study examine how the combination of the study drugs affects~     myeloma.~      Eligibility:~        -  Participants at least 18 years old who have multiple myeloma that has come back, did~          not respond to treatment, or worsened while being treated.~        -  Participants who may be pregnant will be tested to ensure that they are not pregnant.~      Design:~        -  Participants will be screened with a history and physical examination. Blood work and~          urine samples will be taken. A series of x-rays of all bones will be done. A bone~          marrow biopsy will be done.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer does not grow or spread and no serious~          side effects develop.~        -  There will be up to eight 21-day treatment cycles.~        -  Bortezomib is given by subcutaneous (under the skin) (SC) injection on days 1, 4, 8,~          and 11 of the cycle.~        -  Lenalidomide is given by mouth on days 1 14 of the cycle.~        -  Dexamethasone is given by mouth on days 1, 2, 4, 5, 8, 9, 11, and 12 of the cycle.~        -  Following cycle eight, if the disease is stable or better, participants will receive~          bortezomib SC at the dose given at the end of cycle eight.~        -  Participants will take valacyclovir or acyclovir while taking bortezomib to prevent~          virus infections.~   "
108329|NCT01638286|"~     A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a~     pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy~     male subjects.~   "
107692|NCT01647152|"~     Background:~      - Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops,~     drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type~     of white blood cells called T-cells often have a role in causing uveitis. In some cases of~     uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces~     inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat~     uveitis.~      Objectives:~      - To see if ustekinumab can be used to treat uveitis.~      Eligibility:~      - Individuals at least 18 years of age who have active uveitis that needs treatment.~      Design:~        -  Participants will be screened with a physical exam, eye exam, and medical history.~          Blood and urine samples will be taken.~        -  Participants will have at least eight clinic visits during the 64-week study period.~          After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks.~        -  Participants will have a ustekinumab injection at the first study visit. They will have~          additional doses at the second and third visits, and then every 12 weeks until 1 year~          after the first dose (Week 52).~        -  Treatment will be monitored with frequent blood tests and eye exams. Other standard~          treatments for uveitis may be given as needed.~        -  There will be a final study visit 3 months after the last injection.~   "
107693|NCT01646866|"~     Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and~     communication identified before the age of 3 years. Modified Checklist for Autism in~     Toddlers (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited~     number of studies with a small number of patients have documented the developmental profile~     of children with ASD during infancy. Retrospective evaluations of videotaped behavior of~     children with ASD at 8 months and at 12 months identified early signs of ASD. A few studies~     found early signs of ASD during infancy in siblings of autistic children. Data documenting~     the age of onset and regression in ASD is controversial and limited. No large prospective~     studies documented the specific developmental profile of children with ASD starting at 6~     months of age. Defining a specific autistic pattern on a developmental screening test could~     help identify infants at risk for ASD and improve their outcome through earlier diagnosis~     and treatment. More recently, genetic tests have been shown to aid in early identification~     of ASD which facilitates earlier intervention. Genetic testing among siblings of children~     with autism can aid in identification of autism or other related disorders in the siblings.~      PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings~     of children with autism spectrum disorders.~        -  The investigators will enroll siblings of children with ASD. Those siblings who~          completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months~          and failed the RFC at 12 months will be given a genetic screening test.~        -  It is the investigators goal to define a specific autistic pattern on a developmental~          screening test that could help identify sibling infants at risk for ASD and improve~          their outcome through earlier diagnosis and treatment and to evaluate if the results of~          the clinical screening test will correlate with the results of the genetic screening~          test.~   "
107694|NCT01646853|"~     The objective of this study is to determine the optimal radiation dosage used in concurrent~     chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an~     initiate dose of 50Gy conventionally applied in Western countries.~   "
107695|NCT01646840|"~     This study will assess the relative bioavailability of a capsule formulation of PF-04958242,~     relative to a oral solution formulation of PF-04958242 in healthy adult subjects.~   "
107696|NCT01646827|"~     The purpose of this study is to determine whether aripiprazole injection into the shoulder~     or the buttocks produces similar effects in the body~   "
107697|NCT01646814|"~     This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal~     injury after the oral administration of an investigational product, PL2200, and a marketed~     325 mg immediate-release aspirin product. Each group will be treated with either an~     immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and~     evaluated via an endoscope for any gastrointestinal injury that may have been caused by~     study medication.~   "
107698|NCT01646801|"~     The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's~     drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral~     arterial disease.~   "
107699|NCT01646788|"~     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's~     percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of~     Arteriovenous (AV) Dialysis Fistulae/Grafts.~   "
107700|NCT01646775|"~     Background: For cancer to grow and metastasize, inflammatory and immunologic conditions in~     the host must be favorable. The perioperative period provides inflammatory and immunologic~     changes that may be pro-malignant. Anesthetic medications, including the use of opioid~     medication, may contribute to these changes.~      Hypothesis: The investigators hypothesize that perioperative immunologic changes in patients~     undergoing resection of hepatic colorectal cancer recurrence, as measured by natural killer~     cell function and cytokine levels, will undergo less alterations in those who receive only~     epidural bupivacaine, as compared to those who receive epidural bupivacaine and fentanyl.~      Methods: In this double blind control trial patients with no extra-hepatic evidence of~     cancer, undergoing a planned curative resection of hepatic recurrence of colorectal cancer,~     will be randomized to receive an epidural with bupivacaine and fentanyl, or bupivacaine~     alone. No other perioperative opioid medication will be given, and post-operative analgesia~     will be supplemented with acetaminophen and gabapentin. Blood samples and pain ratings using~     a verbal analogue scale will be obtained preoperatively, immediately and 6 hours~     postoperatively, and then daily until removal of the epidural catheter. Samples will be~     analyzed for levels of interleukin 2, 6, 8, 10, 12, 16, 17,TNF-α, TGF α and β, MCP-1, CRP,~     and NK cell activity. Cytokines will be measured using a suspension bead array immunoassay~     kit, and NK activity will be measured using flow cytometry of isolated peripheral blood~     mononuclear cells exposed to the K562 cell line and treated with fluorescent antibodies to~     intracellular markers of activation. Data will be compared between groups using t-tests, or~     Mann-Whitney tests as appropriate. To demonstrate a 50% smaller decrease of NK cell activity~     in the bupivacaine group as compared to the bupivacaine and fentanyl group the investigators~     will need to randomize a total of 30 patients.~   "
107701|NCT01646762|"~     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation~     works in treating patients with multiple myeloma that has returned or did not respond to~     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading.~   "
107702|NCT01646749|"~     The purpose of this study is to determine ad libitum daily energy intake, body weight~     changes and appetite profile in response to protein/carbohydrate and fat ratio over 12~     consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and~     obesity-associated (FTO) gene alleles.~   "
107703|NCT01646736|"~     Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with~     oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of~     patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical~     trial. Observation period of 24 weeks.~   "
107704|NCT01646723|"~     The objectives of our project are to: 1.) Develop a training program and manual for~     volunteers to implement evidence-based, non-pharmacological interventions for~     neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit~     and train volunteers using the VALID program and pilot test the volunteer-led program with~     20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.)~     Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life,~     volunteer's experience, and LTC staff stress.~   "
107705|NCT01646710|"~     The study aims to explore ways in which optifood can be developed to create relevant food~     based recommendation (FBR) and to used for advocacy purposes.~      The optifood tool will be pilot tested with relevant organizations and refine FBRs for the~     target population. Its performance will be assessed in the hands of Government/NGOs in Peru,~     Thailand and India to provide guidance on incorporating into their advocacy programs.~     Qualitative and quantitative methods will be used.~   "
107706|NCT01646697|"~     This study is being done to investigate another way of evaluating margin status after~     pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional~     method of surgical pathology~   "
107707|NCT01646684|"~     After failure of initial ADT, addition of an anti-androgen is established to treat~     castration resistant prostate cancer (CRPC). Substitution of the first anti-androgen and~     anti-androgen withdrawal results in treatment responses in 25-40% of patients for 4-6~     months. A more effective second line treatment after failure of first ADT could prolong the~     time until the state of symptomatic HRPC, which is currently treated with docetaxel and~     accompanied by significant side effects. Since the importance of the IGF-signaling in PC is~     not only indicated by preclinical results but also by clinical efficacy of somatostatin~     analogs, further clinical research with the new somatostatin analog pasireotide is~     warranted.~      This study is designed to define the maximum tolerated dose (MTD) of pasireotide LAR in~     patients with castration resistant prostate cancer (CRPC). It also aims for a preliminary~     efficacy evaluation of pasireotide within the dose expansion part at the MTD. Preliminary~     efficacy will be assessed by evaluation of different measures of prostate cancer e.g.~     changes in PSA, disease control rate (RECIST 1.1), symptoms and changes of biomarkers linked~     to the mode of action of pasireotide LAR. The study will also explore characteristics of~     patients who might benefit most from this treatment approach.~   "
107708|NCT01646671|"~     This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive~     Japanese patients~   "
107709|NCT01646645|"~     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.~     T-cells are a type of white blood cell that helps protect the body from infection. A~     transfusion is the process by which blood from one person is transferred to the blood of~     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.~     The T-cells are then grown and taught to attack the CMV virus in a lab.~   "
107710|NCT01646632|"~     Questions: Does an evidence-based exercise program increase activities of daily living and~     physical fitness in institutionalized older adults? Does this program decrease the care~     dependency of institutionalized older adults? Design: A randomized control trial using~     group-based exercise was performed in 14 assisted-living facilities for the elderly (>70~     years old).~      Outcome measures: Outcome measures were performance on ADL, physical fitness, and care~     dependency measures. The exercise program comprised group-based progressive resistance~     training, balance training, and functional training. The control intervention comprised~     social group meetings.~   "
107711|NCT01646619|"~     The purpose of this study is to assess whether the addition of a drug such as Magnesium~     sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated~     at birth provides additional benefit to the babies' survival and outcome compared to cooling~     alone.~   "
107712|NCT01646606|"~     In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a~     virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a~     probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor~     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours~     (intermittent oxygen monitoring). There is reason to believe that placing children with~     bronchiolitis on continuous monitoring might result in children staying longer in hospital~     than needed. This is a research study that is aiming to provide data to plan a larger~     research study to answer the question of whether intermittent oxygen monitoring is better~     than continuous oxygen monitoring. This study is part of a larger initiative to determine~     the best way to care for children with bronchiolitis, including making sure that children do~     not stay in hospital longer than needed.~      Parents will be asked to participate in this research study if their child is hospitalized~     with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not~     having more trouble breathing or does not require more supplemental oxygen. If they agree~     participate, the child will have one of the two oxygen monitoring strategies: intermittent~     or continuous monitoring. Each child will have an equal chance of getting one or the other~     of these two monitoring strategies.~      The study team will review the children's charts to determine the number of tests ordered,~     the need for intensive care unit help or admissions, the number of blood tests and chest~     x-rays the treating doctors ordered, and the length of hospital stay. Parents will be~     contacted about 4-5 days after discharge to ask if there were any unscheduled visits to~     doctors or emergency rooms after discharge. The investigators will the parents to fill out a~     scale twice a day asking how well their child is feeding. The investigators will also them~     to rate their anxiety level once a day.~      The information from this study will help plan and support an application for external~     funding. The results of a larger study could potentially decrease unnecessary monitoring,~     oxygen supplementation, and hospital stay and thereby improve quality of care with large~     cost savings. A reduction in length of hospital stay for this common hospital condition~     would also reduce the burden of hospitalization to families and reduce the risks associated~     with harm in the hospital setting such as infection and medical error.~   "
107713|NCT01646593|"~     The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic~     and / or unresectable GIST who have progressed after standard therapy.~      Selected additional safety information on regorafenib will be collected and progression-free~     survival (PFS) will be estimated.~   "
107714|NCT01646580|"~     Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown~     activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of~     action is based on a fungicidal activity by inhibiting the cellular captation of essential~     substances needed for the metabolism and growth of the fungi. On the other hand, this drug~     binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell~     wall. After dermal application, Ciclopirox olamine undergoes skin penetration, being only~     absorbed a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10~     years with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis~     versicolor) and the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of~     twice a day topical application. In all the studies, the safety profile has been very good,~     showing only a very low rate of adverse events of mild to moderate intensity. There are very~     few previous available data on the application of this compound in children under 10 years~     of age. A single study had been performed with a solution formulation in patients from 6 to~     29 months with diaper candidiasis, showing good efficacy and tolerability in these patients.~     The present study aims to show the safety and tolerability of ciclopirox olamine in a cream~     formulation in patients from 3 months to 10 years with dermatomycoses.~   "
107715|NCT01646567|"~     The purpose of this study is to assess the safety, tolerability and clinical activity of the~     SHP-141C topical cream formulations in patients with plaque type psoriasis.~   "
142473|NCT01189773|"~     Prospective study to evaluate the additive value of codeine on ibuprofen in the management~     of pediatric patient with a trauma of a limb.~   "
107716|NCT01646554|"~     Patients presenting with multiple innumerable liver metastases will probably never come to~     resection, however, for all others, including patients with numerous multiple metastases or~     large metastases, resection should be considered after limited chemotherapy.~      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.~     FOLFOX was used in the previous EORTC study and is again recommended.~      The addition of targeted agents to standard chemotherapy in the perioperative strategy for~     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,~     therefore translating to a better outcome.~      BOS2 (EORTC 40091) was designed to test this hypothesis in patients with a KRAS wold-type~     profile.~      It was decided in parallel to design an open label, randomized, multi-center, 2-arm phase~     II-III study this time aimed at enrolling KRAS mutated patients.~      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Aflibercept + Surgery~   "
107717|NCT01646541|"~     Most patients with mitral valve disease are symptomatic with shortness of breath and a~     limited activity level prior to mitral valve surgery. Despite surgical repair or replacement~     of the mitral valve, many patients remain symptomatic with an impaired ability to live an~     active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular~     dysfunction, or valvular heart disease is responsible for the continued symptoms, and some~     of these patients will be limited by persistent pulmonary hypertension (PH) at rest or with~     exertion that is responsible for limiting their activity level and impacting their quality~     of their life.~      It is our goal in the proposed study to systematically characterize symptomatic and~     asymptomatic patients greater than six months after mitral valve surgery using clinical~     data, echocardiographic evaluation, laboratory assessment, and in some patients, invasive~     hemodynamic measurements. The investigators will screen asymptomatic and symptomatic~     patients with resting echocardiography and also with echocardiography during exercise, as~     many patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary~     artery (PA) pressure will be estimated from echocardiography using Doppler-derived~     calculations. If elevated PA pressures are observed with echocardiography, then symptomatic~     patients will undergo right heart catheterization for invasive pressure measurement, which~     is the gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge~     pressure (PCWP) during invasive pressure measurement, further assessment to identify~     potential candidates for PH therapy will be performed. This involves having patients breathe~     inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While~     breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will~     be monitored to characterize individuals who could benefit symptomatically from~     pharmacotherapy to treat underlying PH. It is important to note that only a small minority~     of patients exhibit a positive vasodilator response and those with PH and a normal PCWP~     without an initial vasodilator response would still be identified as candidates for chronic~     PH therapy.~      The information generated from this proposed research will make a significant contribution~     to the understanding of PH in a group of patients in whom it has not been previously~     studied. Scientific reports on the evaluation of patients with PH after mitral valve surgery~     are almost nonexistent from the modern era. Furthermore, patients with PH due to mitral~     valve disease have been excluded from clinical trials of agents currently approved by the~     U.S. Food and Drug Administration (FDA) to treat PH. Therefore, this work will carefully~     characterize PA pressures in an objective manner in a group of patients following mitral~     valve surgery who remain limited with respect to their activity levels. In addition, the~     investigators will gain a better understanding of the frequency with which patients have PH~     and a normal PCWP, which identifies a cohort of patients who could have an improvement in~     their symptoms and quality of life with chronic vasodilator treatment.~   "
107718|NCT01646528|"~     The study aims to:~        1. Explore the properties of mesenchymal black spots, and to determine the value of~          mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser~          endomicroscopy (CLE).~        2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in~          patients with gastric mesenchymal black spot during CLE imaging.~   "
107719|NCT01646515|"~     The purpose of this study is to determine if udenafil improves exercise tolerance in~     patients with systolic heart failure.~   "
107720|NCT01646502|"~     Chronic wounds cause significant morbidity and cost our healthcare system millions of~     dollars each year.Their healing is slowed by biofilms, communities of bacteria surrounded by~     a protective layer that stops the immune system and antibiotics from getting close enough to~     kill them. The investigators will develop a new strategy to destroy biofilms using a protein~     made from bacteria that live on our skin.The Staphylococcus epidermidis Esp protein will be~     used to destroy Staphylococcus aureus biofilms, the most common bacterium in chronic wounds.~     The investigators hypothesize that the use of the Esp protein will breakdown S. aureus~     biofilms, decrease bacterial colonization of chronic wounds and improve healing times.~   "
107721|NCT01646489|"~     The purpose of this study is to assess the safety, tolerability, and affect on blood levels~     of miravirsen and telaprevir when administered together.~   "
107722|NCT01646476|"~     Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to~     intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic~     stent (SEMS) insertion has excellent technical and clinical success rates for relieving~     gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis~     because of tumor ingrowth through openings between the stent wire filaments. Therefore, the~     most common reason for stent failure in uncovered stents is tumor ingrowth.~      The covered SEMS has a membrane that prevents ingrowth through the mesh wall and~     consequently shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has~     a higher risk of stent migration compared to uncovered SEMS. Recent prospective, randomized~     study showed that there was no significant difference between uncovered and covered SEMS in~     terms of stent patency rate as well as technical and clinical success rates.~      Recently the investigators developed new covered SEMS for gastric outlet obstruction. This~     new covered SEMS has features that may contribute to reducing migration rate: 1) partially~     covered design; 2)less radial force in central portion of stent; 3) presence of lasso which~     enable position of stent to be adjusted after deployment; 4)presence of protrusion in both~     sides of stent. This prospective, randomized study aimed to compare the effectiveness and~     side effects of newly developed covered SEMS with those of uncovered SEMS in patients with~     malignant gastric outlet obstruction from gastric cancer.~   "
107723|NCT01646463|"~     In the U.S., rates of preterm birth and low birth weight have increased over the past 30~     years. Poor birth outcomes are especially high among racial/ethnic minority populations.~     Maternal stress is an important factor that can lead to negative birth outcomes. Thus,~     programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot~     work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the~     pilot study had lower stress and improved coping after the program. For the current study,~     mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy~     (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a~     version of CP infused with mindfulness skills training. Effects of the two versions of CP on~     psychological stress and coping, stress hormones, and birth outcomes will be tested. Data~     will be collected from participants three times: twice during pregnancy and once after~     birth. Medical records will provide data on birth outcomes and other health factors. The~     study will provide initial information about a mind-body program to reduce stress and~     improve birth outcomes. Data from the study will inform the development of an R01 proposal~     for a larger study. The study will also help advance the long term goal of reducing health~     disparities.~   "
107725|NCT01646437|"~     The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants~     (women 60 years or older and men 55 years or older) without known heart disease or prior~     stroke and without a clear indication or contraindication to any of the study medications.~     Eligible and consenting individuals will be randomized to receive either the active study~     medications or placebo (dummy pills) and will be monitored for an average of 5 years. The~     study will include people from at 10 countries, will be conducted by an international group~     of scientists and physicians and will be coordinated by the Population Health Research~     Institute at Hamilton Health Sciences.~   "
107726|NCT01646424|"~     The aim of this study is to describe patient preferences on budesonide/formoterol fix dose~     combination for the treatment of their COPD, and to find those factors more strongly~     associated to a better attitude to medication.~   "
107727|NCT01646411|"~     For the development of a Point of Care IVD test kit for acute phase disease detection~     against a variety of bacterial and viral infections. Phase one includes 100 clinical~     diagnosed positive and 200 clinically normal serum and whole blood matched specimens for~     specificity and sensitivity determination for each marker. The positive samples must be IgM~     positive using any FDA cleared ELISA test kit. The negatives samples must be negative for~     IgM.~   "
107728|NCT01646398|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a~     single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of~     23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and~     older.~   "
107729|NCT01646385|"~     This study will assess the rates of serious adverse events and death in adult rheumatoid~     arthritis patients treated with etanercept over the long-term in real-life clinical~     practice. It will also assess whether there is any difference in the rate of serious adverse~     events in patients trated with etanercept in comparision to patients treated with~     conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition~     quantify the efficacy of etanercept in this population by assessing the rates of important~     clinical outcomes such as changes in disease activity and disability/functioning.~   "
107730|NCT01646372|"~     The purpose of this study is to investigate whether formal instruction on the use of~     cognitive aids in managing a crisis will result in better longterm retention of knowledge~     and skills. In particular, this study examines the impact of cognitive aid teaching on the~     Advanced Cardiac Life Support course.~   "
107731|NCT01646359|"~     In patients under mechanical ventilation, Usefulness of dynamic indices based on the~     heart-lung interactions for guiding volume resuscitation has been well validated. Recently,~     validity of pulse pressure variation (PPV) has been also reported to predict fluid~     responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important~     hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated~     and used as a preload index, and has been reported to predict fluid responsiveness. Prone~     position caused physiologic and hemodynamic changes and influenced the predictability and~     cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled~     study, the investigators evaluated the validity of PPV and FTc as predictors for fluid~     responsiveness in supine and prone position in patients undergoing posterior lumbar spinal~     fusion~   "
107732|NCT01646346|"~     The Purpose of this study is to evaluate the feasibility of using image guidance and~     four-dimensional computed tomography to reduce the volume of non target breast tissue that~     is treated with accelerated partial breast irradiation via the external beam technique.~   "
107733|NCT01646333|"~     This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving~     training compared to supportive therapy in individuals with Parkinson's Disease with Mild~     Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned~     to receive memory and problem solving training or supportive therapy for 2-months. A 6-month~     follow up evaluation will establish if benefits remain over time. Impact of these therapies~     on thinking abilities, physical health, and patient and support person ratings of thinking~     skills, mood and quality of life will be evaluated. The memory and problem solving training~     is hypothesized to result in greater improvements and/or stability of function on~     neuropsychological tests of attention, working memory, learning, and memory skills compared~     to the supportive therapy condition. Both conditions are hypothesized to result in improved~     mood and quality of life ratings.~      Results from this study will determine whether memory and problem solving therapies and~     supportive therapy are easily used by and beneficial for individuals with Parkinson's~     Disease and Mild Cognitive Impairment. If positive benefit is observed, information from~     this study will be used to further optimize these therapies for larger trials designed to~     evaluate the value of the therapies for individuals with Parkinson's Disease and their~     support persons.~   "
107734|NCT01646320|"~     The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple~     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes~     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of~     this treatment will also be studied.~   "
107735|NCT01646307|"~     This randomized, open label, parallel-group study is designed to investigate whether~     periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration~     before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of~     cardiovascular events for Chinese elderly patients.~   "
107736|NCT01646294|"~     The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed~     and eliminated from the body, and how well it is tolerated, when given in three different~     tablet formulations (sustained release) once a day with and without food, and to compare the~     results with the profile of the YM178 immediate release formulation taken twice daily~     without food.~   "
107775|NCT01645774|"~     Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study~     aimed to Identify and compare the effects of four different injection duration on pain and~     bruising associated with subcutaneous injection of heparin in 90 patients. Four injection~     methods were used for them:~      A: 10s injections duration~      B: 10s injection duration and waiting 10s before withdrawing the needle~      C: 15s injection duration and waiting 5s before withdrawing the needle~      D: 5s injection duration and waiting 15s before withdrawing the needle.~      Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was~     measured by pain visual analogue scale immediately after the injection. Data will be~     analyzed by SPSS.~   "
107737|NCT01646281|"~     Atrial fibrillation (AF) is associated with decreased atrial contractility which is~     associated with stroke. Decreased contractility becomes apparent after cardioversion of~     atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved~     contractility immediately after cardioversion may prevent arrhythmia progression. In~     addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to~     convert atrial fibrillation to sinus rhythm and at the same time increase atrial~     contractility. The latter has not yet been shown in humans and is subject of the present~     investigation. Our hypothesis is that in humans the contractility of the atria is higher~     after administration of vernakalant compared to flecainide. If indeed vernakalant improves~     atrial contractility after cardioversion further studies into the effect on long-term~     arrhythmia progression and stroke prevention may follow.~   "
107738|NCT01646268|"~     The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious~     in Chinese subjects with early-stage idiopathic Parkinson's disease.~   "
107739|NCT01646255|"~     The primary objective of this study was to demonstrate that Rotigotine transdermal patch is~     efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an~     adjuvant therapy.~   "
107740|NCT01646242|"~     Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm.~     However, complete removal of diminutive polyps is required to prevent tumor recurrence and~     development of potential interval cancers. Currently, a variety of polypectomy techniques~     such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the~     removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there~     are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal~     of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare~     polypectomy with cold forceps polypectomy using double biopsy technique for removal of~     diminutive colorectal polyps.~   "
107741|NCT01646229|"~     Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed~     pathogens and associated with high levels of endotoxin. The injury to the endothelium~     results in an increase of endothelial permeability, interstitial edema and release of nitric~     oxide (NO) that is a very potent vasodilatator. [6] Polymyxins obtained from the~     Gram-positive bacterium Bacillus polymyxa are antibiotics known for their ability to bind~     LPS in the outer membrane of the Gram-negative bacterial cell wall as well as free~     endotoxins with high affinity. Polymyxin-B has been shown to block the activation of cells~     by a wide variety of LPS. Studies converged to show an improvement in the treatment of~     septic shock by removing circulating endotoxin.Starting Polymyxin-B hemoperfusion during the~     operative time is to block the initiation of various deleterious biological cascades induced~     by endotoxemia such as systemic inflammation, disseminated coagulation disorders, and shock,~     leading to organ dysfunction and death.~   "
107742|NCT01646216|"~     The purpose of this study is to determine whether split belt or conventional treadmill~     training can be used to treat walking pattern deficits from stroke and to determine whether~     this improves gait asymmetry and metabolic efficiency.~   "
107743|NCT01646203|"~     A study to evaluate the safety and tolerability of IMC-TR1 in patients with advanced solid~     tumors, as well as gather evidence of anti-tumor activity.~   "
107744|NCT01646190|"~     Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce~     perioperative surgical stress and injury after colorectal surgery, resulting in lower~     morbidity and enhanced recovery. As fast-track approach could probably be the most~     beneficial for senior patients to reduce postoperative morbidity and better preserve~     independency, only scarce information is available in senior population. Therefore a~     randomized controlled trial is initiated in our institution compare a senior dedicated~     fast-track approach to modern standard care after colorectal surgery.~   "
107745|NCT01646177|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to~     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.~   "
107746|NCT01646164|"~     Dill is herbaceous and aromatic herb used in order to convenient and shorter labor in Iran.~     The objective of this study was to evaluate the effect of Dill seed on uterus contractions~     in active phase of labor.~   "
107747|NCT01646151|"~     An observational study comparing changing from an IOP-lowering treatment to a~     bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular~     hypertension (OHT). Visits and treatment are per normal clinical practice.~   "
107748|NCT01646138|"~     Background:~      - A challenge study exposes a person to a disease and allows researchers to study the~     disease through the body's healing process. An influenza challenge study that looks at~     different amounts of the flu virus can provide more information on the smallest amount~     needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1~     virus to healthy volunteers to see how the body responds to the virus.~      Objectives:~        -  To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate~          flu infection in a healthy adult.~        -  To study how the body s immune system responds to the virus.~      Eligibility:~        -  Healthy volunteers at least 18 years of age.~        -  Participants must be willing to remain in isolation for a minimum of 9 days.~      Design:~        -  Participants will be admitted to a hospital inpatient isolation unit. They will be~          screened with a physical exam and medical history. They will also have heart and lung~          function tests. Blood, urine, and nasal swab/wash samples will be collected.~        -  Participants will receive a single nasal spray of the flu virus. They will stay on the~          inpatient unit for at least 9 days.~        -  Participants will be monitored for the length of their stay. They will have frequent~          blood tests and other procedures as needed.~        -  Participants will be allowed to go home once they have had two negative tests for the~          virus. The tests will be given on two consecutive days....~   "
107749|NCT01646125|"~     The purpose of this study is to determine if AUY922 has superior efficacy when compared to~     chemotherapy agents docetaxel or pemetrexed in patients whose tumor have EGFR mutations.~   "
107776|NCT01645761|"~     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a~     reduction in mucus viscosity. As part of the search for more effective forms of therapy~     against H. pylori when it colonizes not only the surface of the surface mucosal cells but~     also the surface mucous gel layer covering the mucosal surface of the stomach. The~     investigators decided to investigate whether or not endonase might have additive effect of~     pronase on the efficacy of eradication therapy against Helicobacter pylori.~   "
107750|NCT01646112|"~     Background:~        -  Individuals have varying tolerances for receiving ambiguous information. However, not~          much is known about how ambiguous genetic testing information is received. Also, not~          much is known about how at-risk individuals internalize and process these results. More~          information is needed about how this information affects a person s life.~        -  Lynch Syndrome is a genetic condition that carries a high risk of colon cancer and~          other cancers. Individuals at risk for Lynch Syndrome can have genetic testing for it.~          The test may confirm a diagnosis and determine actions that can be taken. Results from~          genetic testing can also affect the perspectives of relatives who might also be~          affected. However, genetic testing can also produce variants of unknown significance~          (VUS). VUS are data that may not provide enough information to make decisions.~          Researchers want to study people who have received a VUS result for genetic testing for~          Lynch Syndrome.~      Objectives:~      - To learn more about the impact and experience of receiving a VUS for Lynch Syndrome~     genetic testing.~      Eligibility:~      - Individuals at least 18 years of age who have recently had a VUS result on a genetic test~     for Lynch Syndrome.~      Design:~        -  Participants will be asked to answer demographic questions. They will also have a 45-~          to 60-minute phone interview.~        -  During the phone interview, participants will be asked a series of questions about~          their diagnosis. They will be asked about how they received the result and how they~          felt right after receiving it. They will also discuss who they have spoken to about the~          result.~   "
107751|NCT01646099|"~     This study is being done to evaluate the effectiveness of a Sun Protection Strategies~     internet-based program for kidney transplant recipients. Since the medication taken to~     preserve the kidney transplant puts kidney transplant recipients at increased risk of~     developing a sunburn as well a skin cancer, the program will help people learn how to~     practice effective sun protection for their condition.~   "
107752|NCT01646086|"~     To achieve the long term goal of strengthening behavioral weight loss programs, the purpose~     of this project is to test an enhanced, daily weight tracking instruction against the~     current standard of care (weekly weight tracking) and an alternative mode of care (no weight~     tracking).~      The investigators postulate that daily weight tracking will boost ongoing awareness of and~     engagement in dietary intake and physical activity monitoring, thus improving weight loss~     outcomes. The central hypothesis of the study is that daily weight tracking will improve~     weight loss processes and outcomes relative to less frequent weight tracking, without~     adverse effects.~   "
107753|NCT01646073|"~     A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate~     to severe plaque psoriasis.~   "
107754|NCT01646060|"~     Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood~     volume and blood loss of a patient during surgery, post operatively and/or in recovery. This~     monitoring device will identify baseline blood volume and relative changes in blood volume~     using a specific algorithm to compare and review data already monitored during surgery,~     displaying blood volume and blood loss in real-time.~   "
107755|NCT01646047|"~     This study will evaluate the effects of a novel multi-component dietary supplement on the~     visual function and retinal structure of patients with diabetes with both no diabetic~     retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial~     and neither subjects nor examiners will know if any given subject is taking active~     supplement or placebo.~      The hypothesis is that the supplement will improve visual function and retinal structure in~     subjects on active supplement~   "
107756|NCT01646034|"~     This study investigates the effect of high-dose alkylating chemotherapy compared with~     standard chemotherapy as part of a multimodality treatment approach in patients with~     oligo-metastatic breast cancer harboring homologous recombination deficiency.~   "
107757|NCT01646021|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus~     temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at~     least 1 prior chemotherapy regimen.~   "
107758|NCT01646008|"~     The purpose of this study is to study the correlation between carbon dioxide measured by~     capnography at the enf of exhalation and arterial blood in COPD patients with nasal cannula~     in critical care unit.~   "
107759|NCT01645995|"~     Specific policies on obesity reduction often include a recommendation to reduce sugar~     consumption as a means of lowering overall caloric intake. Reformulating processed foods~     (e.g. sugary products) is considered one of the key options for improving population diet.~     The implications of regular consumption of reformulated products are not fully understood.~     Previous studies have demonstrated that dietary compensation is common, although the extent~     is not fully elucidated. In addition to the perceived impact of sugar consumption on weight~     control, high sugar intake, specifically sucrose and fructose, has been implicated in the~     increase of plasma lipids and markers of insulin resistance. However to date no randomised~     controlled study has investigated whether the consumption of reformulated low sugar products~     as components of a habitual diet have a significant impact on plasma lipid, insulin or~     glucose concentrations within a free-living, non-diseased population. It is hypothesised~     that exchange of reformulated, low sugar food products for habitually consumed foods will~     result in dietary compensation and minimal weight change compared with unmodified products~     and will have little impact on plasma glucose, insulin and lipid levels.~   "
107760|NCT01645982|"~     The purpose of this study is to compare the changes measured by Somanetics Invos cerebral~     oximeter to the mean arterial pressure at brain level in patients having elective shoulder~     replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation~     (rS02) of blood in the brain tissues to help prevent brain injury or other complications.~     The investigators hypothesize that maintaining normocarbia and systemic mean arterial~     pressure at or above 70mmHg during general anesthesia in the beach chair position will~     decrease the number of cerebral deoxygenation events during the procedure.~   "
107761|NCT01645969|"~     This multicenter, prospective, observational study will evaluate the one-year outcomes in~     HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a)~     in Arm A of study ML22265. Data will be collected from each patient for up to one year~     post-therapy.~   "
107777|NCT01645748|"~     The purpose of this study was to evaluate the tolerability and efficacy of a combination of~     weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with~     locally advanced head and neck squamous cell carcinoma (HNSCC).~   "
107762|NCT01645956|"~     The importance of exercise for weight control is well documented; however if exercise~     results in an increase in food intake, the beneficial effect of exercise may not be seen.~     This study addresses a gap in the current literature and examines why some people eat more~     after exercise and why some people eat less and also examines whether these responses are~     consistent over time. Participants in this study will be asked to come to our center on 7~     different occasions over a 3-4 month period. The first visit will be an assessment visit~     where body weight and body composition will be measured, questionnaires will be completed,~     and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions~     with visits in each pair separated by 48-96 hours) the procedures will be nearly identical.~     Upon arrival at our center, participants will consume a meal replacement, complete a series~     of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be~     resting and 3 will be exercising). One hour following the exercise/resting session,~     individuals will be given access to a buffet of food, unaware that their food intake will be~     monitored. All food will be weighed and measured before and after the eating period and the~     amount of food consumed after each pair of exercise and resting conditions will be compared~     to one another. It is hypothesized that the difference in food intake will be consistent~     across pairs of testing sessions. Findings from this study will help us to better understand~     the relationship between exercise and food intake and may ultimately lead to future studies~     that can address the clinically significant question of why some individuals gain weight and~     others lose weight when engaging in exercise training programs. Findings from this study may~     also help to develop exercise programs that maximize the beneficial effect of exercise on~     body weight.~   "
107763|NCT01645943|"~     The guidelines of clinical practice, based on the randomized studies, recommend an invasive~     strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with~     comorbidities are excluded from the randomized studies and the observational registries~     showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to~     investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.~      Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities,~     will be included. The latter will be defined as at least 2 of the following: peripheral~     artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic~     renal failure and anemia. The included patients will be randomized to an invasive (routine~     coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible~     ischemia) strategy. All patients will receive medical treatment according to current~     recommendations.~      The main outcome will be death, reinfarction or readmissions by heart cause at one-year~     follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients~     with NSTEACS and comorbidities.~   "
107764|NCT01645930|"~     The purpose of this Phase 1 study is to characterize the Pharmacokinetic (PK) and~     tolerability of Oral IXAZOMIB when administered in combination with lenalidomide and~     dexamethasone in adult Asian patients with Relapsed and/or Refractory Multiple Myeloma~   "
107765|NCT01645917|"~     The purpose of the study is to determine the permanency of PV isolation with the Arctic~     Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on~     acute procedural outcomes and measures as well as clinical AF recurrence in these patients~     approximately 3 months post-ablation.~   "
107766|NCT01645904|"~     The goal of this research study is to create an internet-based program designed to improve~     the communication of health and health history information among family members affected by~     Lynch syndrome.~   "
107767|NCT01645891|"~     The purpose of this study is to evaluate the safety and effectiveness of Continuous~     Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary~     objective of this study is to evaluate the effectiveness of CDO in combination with standard~     moist wound therapy (MWT) on wound healing as compared to standard MWT alone.~   "
107768|NCT01645878|"~     Exclusive breastfeeding is very important for an infant's growth and development.~     Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is~     defined as a mother's confidence in her perceived ability about successful exclusive~     breastfeeding. Self- efficacy beliefs function as an important set of human motivation ,~     affect , and action which operate on action, through motivation, cognitive and affective~     interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult~     learning principles were incorporated in this research design. In regards with the~     importance of education in increasing breastfeeding self-efficacy and exclusive~     breastfeeding, the current study was conducted in order to compare of the effectiveness of~     two educational methods, i.e., Hands on and Hands off on breastfeeding self-efficacy in~     primiparous mothers.~      In the present clinical trial, 136 nursing mother were randomly assigned to one of the three~     groups. Participants in the experimental groups received one of the structured one-on-one~     educational sessions (i.e., hands off or hands on) within the first two hours of giving~     birth. Mothers in control group received usual postpartum care. Follow-up assessments were~     conducted one, four, and eight weeks after the birth. Data collection was done through~     interview forms, examination and observation, checklist of breastfeeding status,~     breastfeeding self-efficacy and daily-feeding form.~   "
107769|NCT01645865|"~     Although gains have been made in achieving the health-related Millennium Development Goals~     (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of~     mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality~     from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health~     facilities randomized to two arms (intervention or control) to determine the effect of~     mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks~     postpartum. The study will examine the acceptability, effectiveness, and cost of~     implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health~     workers, and male partners.~   "
107770|NCT01645852|"~     The purpose of this study is to measure the effect of a short-term low calorie diet on~     patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.~   "
107771|NCT01645839|"~     The purpose of this study is to compare the neurological progression free survival with the~     use of an intrathecal chemotherapy with liposomal cytarabine (DepoCyte®) in leptomeningeal~     metastasis of breast cancer (versus no intrathecal treatment).~   "
107772|NCT01645826|"~     The purpose of this study is to determine if cardizem is effective in the treatment of~     nitric oxide non-responder pulmonary arterial hypertension.~   "
107773|NCT01645800|"~     The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks~     lysozyme administration in patients with COPD.~   "
107774|NCT01645787|"~     The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves~     walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3~     compared to placebo and whether the duration of treatment affects outcome.~   "
145317|NCT01152502|"~     Follow-up of urinary concentration from paracetamol metabolites by patients with aortic~     surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)~   "
107779|NCT01645722|"~     The objective of this pilot study is to assess the efficacy of minimally invasive autologous~     fat transfers at the amputation sites and the modulation of pain at the respective sites.~     Our investigators hypothesize that autologous fat grafting can provide a minimally invasive~     therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume~     stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby~     avoiding major surgical revisions and preserving limb length. The investigators further~     hypothesize that enriching the fat graft with autologous adipose stromal cells, a~     regenerative medicine approach, will lead to improved retention of the fat graft over time~     and result in a more favorable outcome.~      The Investigators will evaluate:~        1. Treatment of painful amputation sites in 5 patients with fat grafting, intended to~          provide additional subcutaneous tissue padding over bony structures and nerve trunks.~          Limb anatomy and healing of the graft over time, along with stability/persistence of~          the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction.~          Patients will be followed for 24 months after treatment to define long term outcomes.~          Patients will be enrolled who have pain at an amputation site that limits function~          and/or interferes with the ability to use a prosthesis.~        2. Biologic properties of the cells within the fat graft and correlate with clinical~          outcomes. This will include adipose stem cell yield per volume of fat tissue, cell~          proliferation, capacity for adipogenic differentiation, lipolysis, and cell~          sub-population analysis by multiparameter flow cytometry. Results of these assays will~          be correlated with graft volume retention to search for predictors of good clinical~          outcome that are related to variation on adipose biology between subjects.~        3. Quality of life measurements in patients before and after autologous fat grafting using~          validated psychosocial measures. This will include SF 36, the Beck inventory, and~          instruments designed for assessing limb function.~   "
107780|NCT01645709|"~     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the~     safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of~     joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all~     analgesic medications for the entire duration of the study, except for acetaminophen (taken~     on an as needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry~     criteria will be randomized to receive a single injection of IA verapamil or IA placebo at a~     ratio of 1:1. Treatments will be given with fluoroscopy or ultrasound to confirm needle~     placement. Subjects will be monitored for blood pressure and heart rate (sitting and~     standing) for at least 1 hour post-injection. Subjects will be evaluated at weeks 1, 2, 3,~     4, 6, 8, and 12 after treatment.~   "
107781|NCT01645696|"~     The purpose of this study is to investigate the accuracy and performance of a new~     subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high~     blood sugar) and hypoglycemic (low blood sugar) clamp conditions and during meal~     excursions over the course of 72 hours as compared to a commercially available monitor.~   "
107782|NCT01645566|"~     This is a prospective randomized controlled study. The aim of this study is to~        1. describe the stress patterns experienced during a CPR situation;~        2. investigate whether the perceived stress was associated with CPR performance in terms~          of hands-on time and time to start CPR;~        3. to investigate whether this task focusing strategy reduces perceived stress levels, and~        4. whether this translates into better CPR performance. Based on findings that clear,~          directive leadership can enhance performance in cardiac resuscitation, we further 5)~          investigate if stress was associated with fewer leadership statements.~   "
107783|NCT01645475|"~     Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a~     mismatch between nocturnal bladder capacity and the amount of urine produced during the~     night together with failure of the child to awaken in response to a full bladder.Urine~     overproduction at night or nocturnal polyuria (NP) is a major factor contributing to~     monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.~      Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion,~     the synthetic AVP analogue desmopressin is widely used to treat MNE.~      It is recommended by the International Consultation on Incontinence (grade A,level 1).~     Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest~     form melt.~      Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity~     disorder (ADHD) in children with MNE According to recent data there is a high incidence of~     periodic limb movements in sleep at night in children with nocturnal enuresis. Those~     children have an increased cortical arousability leading to awakening.~      The frequent awakening most likely has an influence on concentration and other ADHD-symptoms~     in daily life.~      This study will assess the impact of desmopressin melt on prepulse inhibition,~     ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.~      New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and~     sleep problems are tested before the start of the study medication desmopressin melt (T1)~     and 6 months later (T2). It is a multi-method, multi-informant study.~   "
107784|NCT01645449|"~     The purpose of this study is to compare and evaluate the single-dose oral bioavailability~     and to monitor the safety of subjects.~   "
107785|NCT01645436|"~     The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer~     (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer~     patients undergoing chemotherapy for solid tumors. The investigators hypothesized the~     intervention will have a beneficial effect on the study outcomes.~   "
107786|NCT01645423|"~     The purpose of this study is to compare and evaluate the single-dose oral bioavailability~     and to monitor the safety of subjects.~   "
107787|NCT01645410|"~     The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg~     of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland~     Pharmaceuticals in healthy, adult, human subjects under fed condition.~   "
107788|NCT01645397|"~     The purpose of this study is to assess if in steroid naïve asthmatic children with elevated~     baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled~     nitric oxide level results in restoration of the bronchodilator response to deep inhalation.~   "
107789|NCT01645384|"~     The purpose of this study is to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance of Atorvastatin formulations under~     fasting conditions.~   "
107790|NCT01645371|"~     This qualitative research is to assess the validity of the stool symptom screener that will~     be used in patients with chronic opioid-induced constipation to determine the adequacy of~     their response to laxatives.~   "
107807|NCT01645150|"~     The purpose of this pilot study is to determine the effects of a 12-week resistance training~     program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor~     (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can~     be reduced by exercise training in this population which leads to an improved treatment~     completion rate.~   "
145570|NCT01149252|"~     The purpose of this study is to determine the safety and efficacy of a new product,~     Psoralait, as compared to a placebo in the treatment of psoriasis.~   "
107791|NCT01645358|"~     Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation~     (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic~     Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory~     failure, it is largely employed as a rotating strategy when the facial mask is poorly~     tolerated.~      In a multicenter randomized controlled trial, the investigators will compare the clinical~     efficacy of a new helmet designed to specifically improve the performance in chronic~     obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.~   "
107792|NCT01645345|"~     To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the~     treatment of acne scars and wrinkles.~   "
107793|NCT01645332|"~     This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with~     12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic~     control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and~     2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin~     level, lipid profile, and body weight.~   "
107794|NCT01645319|"~     The primary objectives of the study are:~        1. To compare the proportion of patients who achieve a successful response to treatment~          (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser~          surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty)~          with patients receiving additional medications, at 1-year post-treatment initiation.~        2. To compare the proportion of patients who achieve a successful response to treatment~          (reduction in IOP of >15%) between patients treated with other procedures (including~          incisional surgery, drainage device procedures, and other glaucoma procedures) with~          patients receiving additional medications, at 1-year-post-treatment initiation.~      The study is a prospective, observational cohort study and will not provide or recommend any~     treatment. Patients who have failed initial medical therapy with two glaucoma medications~     will be identified and enrolled at the time of scheduling of a laser surgery procedure or~     other procedure such as incisional surgery or drainage device, or initiation of an~     additional course of therapy with medication as determined by their physician. This~     inception cohort of new initiators of laser surgical treatment, other procedures, or~     additional medical therapy will be followed for 12 months. All decisions regarding treatment~     are solely at the discretion of the physician in accordance with their usual practice.~     Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up~     after enrollment targets have been reached.~   "
107795|NCT01645306|"~     Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks~     (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet~     monotherapy or monotherapy alone.~      Patients receive a single dose of trial medication by intravenous infusion for 20 minutes.~     Patients are followed up one and three days after treatment, at 3 months and by a telephone~     interview at 12 months.~   "
107796|NCT01645293|"~     Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment~     with their own genetically modified T cells. Treatment evaluation consists of assessment of~     safety and preliminary evidence of response.~   "
107797|NCT01645280|"~     The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in~     reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA)~     despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and~     CNTO 1959 in this population.~   "
107798|NCT01645267|"~     In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected~     with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from~     the iliac crest to support the osteotomy. In the planned study a group of children will be~     operated with an artificial bone graft material and thus avoiding the need harvesting of~     bone graft at the iliac crest.~   "
107799|NCT01645254|"~     The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of~     the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy~     volunteers.~   "
107800|NCT01645241|"~     The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in~     oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes~     donors . This study will be performed in egg recipients and donors but this type of~     treatment is meant to be implemented in fertility preservation patients~   "
107801|NCT01645228|"~     To validate the capability of non-invasive bio-image tests in prediction of significant~     coronary stenosis of symptomatic adults.~   "
107802|NCT01645215|"~     Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular~     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent~     inhibitory effects on multiple human tumor xenografts. This first-in-human study is~     conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to~     evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at~     single doses and multiple doses .~   "
107803|NCT01645202|"~     A randomized controlled multicenter study comparing the acute hemodynamic performance of the~     Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk~     patients with severe symptomatic aortic stenosis.~   "
107804|NCT01645189|"~     The objective of this study is to determine the safety and efficacy of once weekly dosing of~     idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome~     patients < 6 years old.~   "
107805|NCT01645176|"~     The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is~     to learn about the effects in inflammation and pain in patients with Osteoarthritis of the~     knee. These medications are FDA approved and commercially available.~   "
107806|NCT01645163|"~     The study aims to develop, design pilot a mHealth intervention strengthen complementary~     feeding (CF) components of the ICDS program.~      The methods will include explaining views of caregivers of infants aged 9-11 months, AWWs~     and other ICDS personnel on the feasibility, acceptability and the best means of using~     mobile phones to deliver CF counselling. Based on the feedback an intervention will be~     developed and pilot tested.~   "
107856|NCT01644513|"~     Patients with AMD who are being or have been treated with eye injections of drugs known as~     anti-VEGF agents with either good or poor response will have DNA collected with check swabs~     for analysis.~   "
107808|NCT01645137|"~     The use of complementary and alternative medicine in neonatal ward has been steadily rising~     during the last decade. This integrated medicine approach has been shown to be helpful to~     improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to~     premature infants to reduce the length of stay and to cope with clinical complications.~     Results from previous studies documented the positive association between OMT and shorter~     period of hospitalisation as well as improvement of clinical conditions. The aim of this~     nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in~     premature infants across 3 neonatal intensive care units (NICU).~   "
107809|NCT01645124|"~     CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation~     (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV)~     treated at the best of recommended therapies (e.g.adequate control of standard~     cardiovascular risk factors). Irrespective of randomized interventions, all patients will be~     administered low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic~     treatment in PV patients.~      The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus~     low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at~     maintaining hematocrit (HCT) < 45% is more effective than a less intensive cytoreduction~     (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining~     HCT in the range of 45-50% in the reduction of CV deaths plus thrombotic events (stroke,~     acute coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE],~     splanchnic thrombosis, deep vein thrombosis [DVT], and any other clinically relevant~     thrombotic event), in patients with Polycythemia Vera treated at the best of recommended~     therapies (e.g. adequate control of standard cardiovascular risk factors).~   "
107810|NCT01645111|"~     The current study would prospectively evaluate the dosing requirements, efficacy and safety~     of clevidipine for controlled hypotension during spinal surgery in the pediatric population.~     As the investigators currently have projects underway which include those patients having~     scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing~     scoliosis surgery for neuromuscular disease.~   "
107811|NCT01645098|"~     This is an interventional study on Duchenne muscular dystrophy patients who will be~     receiving sedation for a muscle biopsy as part of another study.~   "
107812|NCT01645085|"~     A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different~     Formulations of Fostamatinib.~   "
107813|NCT01645072|"~     Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic~     epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are~     difficult to control; sometimes only at the expense of multiple and toxic levels of~     antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy~     surgery warrants the need for alternative treatments. Ketogenic diet is effective for~     refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction~     in seizures from the baseline and 15-20% become seizure free) and has gained widespread~     acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic~     diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting~     seizure reduction comparable to that of patients on ketogenic diet. There have been no~     randomized controlled trials assessing the efficacy of the low glycemic index diet in~     refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children~     with drug refractory epilepsy.~   "
107814|NCT01645059|"~     This is an observational, cross-sectional study that the main objective is to describe the~     patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a~     metastasis after or during the adjuvant treatment.~   "
107815|NCT01645046|"~     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A （CoA） capsule in Chinese patients with moderate~     dyslipidemia.~   "
107816|NCT01645033|"~     The purpose of this study is to determine if a computerized version of Cognitive Behavioral~     Therapy (CBT) can improve high-risk sexual behaviors in patients attending an outpatient~     methadone treatment clinic. This population is at high risk for contracting and spreading~     hepatitis and HIV. When added to their treatment as usual (TAU), the CBT session will~     increase the total exposure of clients to education about how to reduce risky sexual and~     needle use behaviors and provides real world examples. This study seeks to determine if the~     use of this CBT program is easily added into the clinical program and if patients are~     satisfied with its use.~      The main hypothesis is that the use of computerized CBT in addition to treatment as usual~     will improve knowledge and reduce occurrences of unprotected sexual activity. The study will~     also look at patient and clinic costs related to the CBT intervention, drug use and~     retention/adherence.~   "
107817|NCT01645020|"~     Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer~     postoperative complications especially less pain caused by the mesh mass.~   "
107818|NCT01645007|"~     Primary Aims:~        1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.~        2. Educate the population in order to reduce transmission~        3. Increase awareness among primary care providers~      Secondary Aims:~        1. Identify chronic HBV infected patients who need to be followed and treated,~        2. Identify HBV infected women in a childbearing age~        3. Identify non immunized individuals and recommend vaccination~        4. Identify previously vaccinated individuals who are not immunized~        5. Identify previously vaccinated individuals who became infected~      Study Design:~      Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000~     people from Druze communities in the Galilee area~      This work will be divided into three sections:~        1. Increasing awareness: lectures and local events will be taken place in the communities.~          Written information will be given and primary care-providers mainly family doctors,~          nurses and obstetric surgeons will be involved.~        2. All participants, upon signing a consent will:~             -  Fill up a questioner~             -  Checked for weight, height and waist circumflex~             -  Have a blood sample taken~        3. Results and recommendations will be forwarded to all participants~   "
107857|NCT01644500|"~     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe~     compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate~     glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.~   "
107819|NCT01644994|"~     The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin)~     combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural~     pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by~     evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety~     and efficacy in phase II with the maximum tolerated dose in phase I.~   "
107820|NCT01644981|"~     Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm~     infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary~     dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is~     directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker~     of BPD.~   "
107821|NCT01644968|"~     This study is designed to determine the safety and highest tolerated dose of anti-OX40 in~     patients with advanced cancer.~   "
107822|NCT01644955|"~     This study is being done to evaluate the toxicity and safety of carboplatin administered by~     convection enhanced delivery into the tumor in patients with high grade glial neoplasms.~     This study is a dose escalating study, (the dose of the study drug is increased at set time~     points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows~     or stops the growth of cancer cells in your body. Convection enhanced delivery involves~     placing one or more catheters into the brain and delivering chemotherapy through those~     catheters directly into the brain~   "
107823|NCT01644942|"~     The study aims to determine in obese patients the implication of intramuscular lipid~     accumulation in relation with insulin resistance and defect in lipid oxidation.~   "
107824|NCT01644929|"~     Rehabilitation after stroke improves motor functions by promoting plastic changes however,~     after completing standard rehabilitation, 50-60% of patients still exhibit some degree of~     motor impairment and require at least partial assistance in activities of day living.~     Therefore, the exploration of other approaches to promote recovery is compulsory. Non~     invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms~     in inducing neuroplastic changes in the human cortex and an emerging field of research is~     focusing on the possibility of coupling both therapies in order to achieve an additive~     effect and improve outcome.~      We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS)~     with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke~     patients may improve upper limb motor recovery in humans.~      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.~     Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers~     of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer~     Assessment Upper Extremity according to the severity of the deficit, the patient will be~     randomized to receive besides standardized physical/occupational treatment according to the~     Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12~     patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of~     treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3~     (12 patients) will receive routine physical/occupational treatment and sham tDCS for six~     weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months.~     Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index,~     the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip~     strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at~     month 6 depression will be assessed by the Hamilton depression Rating Scale.~   "
107825|NCT01644916|"~     Chronic obstructive pulmonary disease (COPD) stands out among chronic diseases with its high~     and rising prevalence and mortality, poor quality of life, high re-hospitalization rates and~     societal burden of care. Current therapeutic and management practices are generally met with~     limited success. Research in recent years have highlighted the high level of psychiatric~     co-morbidity in COPD patients, and the major prognostic significance of anxiety/depression~     in COPD outcomes such as re-hospitalization, smoking cessation, quality of life, and~     survival. This suggests that addressing psychiatric and psycho-social aspects of care~     prominent in COPD patients may have strongly positive impact on outcomes, but the available~     evidence of effectiveness is limited.~      The primary aim of the proposed research is to evaluate the effectiveness of a holistic~     disease management paradigm of psychiatric liaison consultation (CL) that integrates~     psychiatric and respiratory care to improve outcomes for COPD patients. This integrated~     psychiatric consultation liaison (IPCL) management paradigm includes the routine screening~     and structured collaborative care of anxiety and major depressive symptoms and~     depressive/anxiety disorder in COPD patients. We postulate that the IPCL care paradigm would~     reduce mood symptoms, increase smoking quit rates, reduce symptom burden and functional~     disability, and improve quality of life, while reducing rehospitalization, emergency~     department (ED) and unscheduled physician visits. A secondary aim is to evaluate its cost~     effectiveness by concurrently collecting resource utilization data.~   "
107826|NCT01644903|"~     This study is being done to test blood, urine and tissue samples to see if this can help~     decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can~     be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the~     body's ability to function properly. Early detection of these conditions could assist with~     successful treatment and possibly lead to less repeat organ transplants.~   "
107827|NCT01644890|"~     To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to~     paclitaxel in terms of the progression-free survival in patients with metastatic or~     recurrent breast cancer.~   "
107828|NCT01644877|"~     This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen~     and diagnosed with a parainfluenza infection.~   "
107829|NCT01644864|"~     This is a prospective randomized double-blind placebo controlled study (0.375% Ropivacaine~     vs. 0.9% saline) designed to evaluate the effectiveness of transverse abdominis plane (TAP)~     block in the first 48 hours after c-section in patients receiving methadone therapy. The TAP~     block will be performed by a regional anesthesiologist in the operating room after delivery~     of the baby.~   "
107830|NCT01644851|"~     The purpose of this pilot study is to determine the effects of computer-based training in~     executive functioning compared to word games on cognitive and emotional aspects of~     combat-related PTSD.~   "
107831|NCT01644838|"~     It is always considered to shorten the duration of delivery without compromising the mother~     and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research~     is very limited, with conflicting results regarding the efficacy of these two drugs. So the~     investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on~     length of active phase of the first stage of labor.~   "
107832|NCT01644825|"~     The purpose of this study is to evaluate the safety and activity of adding pazopanib to~     weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or~     refractory to treatment with platinum based therapy.~   "
107833|NCT01644812|"~     This two-site (Southern Methodist University (SMU) and Boston University (BU)) study aims to~     examine the effectiveness of exercise interventions for the treatment of generalized anxiety~     disorder (GAD). If effective, the use of exercise as a component of treatment for GAD would~     have a significant public health impact. In addition to improving GAD treatment outcome,~     exercise is expected to offer health benefits and promote further lifestyle changes.~      The present study involves the randomization of 52 adults with GAD to either a 12-week~     combined supervised- home-based moderate-intensity aerobic exercise protocol (EX) or a~     12-week combined supervised- home-based stretching protocol (CTRL). The investigators~     hypothesize that participants in the EX intervention will evidence greater improvements in~     anxiety symptoms and quality of life relative to individuals receiving the control~     intervention.~   "
107834|NCT01644799|"~     Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. This phase I trial studies the side~     effects and the best dose of lenalidomide when giving together with idelalisib in treating~     patients with recurrent follicular lymphoma.~   "
107835|NCT01644786|"~     The purpose of the biobank is to enable future genomic based research on this Head and Neck~     Cancer patient population. The investigators will try to identify tumor factors that will~     predict cancer-related outcome in order to improve the outcome prediction after treatment in~     a patient-individualized manner.~   "
107836|NCT01644773|"~     This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given~     in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of~     high grade gliomas (HGG). Participants will receive escalating doses until the highest dose~     is determined. Participants will be enrolled in two strata: stratum A for recurrent/~     progressive tumors and stratum B for recently diagnosed patients who have completed standard~     radiation therapy without progressive disease. Up to 7 dosage levels will be tested. Both~     drugs are taken orally daily, once per day. Correlative pharmacokinetic and biology studies~     are planned, as well as advanced methods of magnetic resonance imaging (MRI).~   "
107837|NCT01644760|"~     The main objective of this study is to determine a threshold value of diaphragmatic~     excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50%~     collapsibility of the inferior vena cava.~   "
107838|NCT01644747|"~     The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS)~     applied at the anodal left CDLPF of patients with resistant depression compared to patients~     treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant~     depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake~     Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients~     and lithium for bipolar patients). The delay of 4 weeks is a minimum to observe a~     non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8~     weeks to observe the non-response to treatment.~      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients~     (48 unipolar plus 12 bipolar patients per group. Patients will be selected in the~     psychiatric department of the University Hospital of different centers and the two groups~     are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).~      After giving informed consent, patients will be evaluated by a psychiatrist using the~     Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS),~     the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young~     Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist~     assessment will be also realized during 20 minutes using the Crossing of Test (COT), the~     Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.~      After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham~     will be directed by 30-minute session. A psychometric assessment will be conducted again at~     the end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The~     neuropsychologist assessment will be conducted again 4 weeks after the end of treatment.~     Scales of comfort and acceptability will also be proposed to the patient to determine~     whether any gene is caused by this treatment.~      These people will be recruited on a voluntary basis, after notification and consent in the 6~     research centers. This study was conducted over a period of 36 months.~      This study was supporting by a grant from the French Hospital Program of Clinical Reseach~     (PHRC N/2011-60-2011-A01074-37)~   "
107839|NCT01644734|"~     To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH~     maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the~     real life setting of COPD patients, previously treated with short-acting bronchodilator on~     regular or as-needed basis.~   "
107840|NCT01644721|"~     Background: All observational studies and a few randomised controlled trials (RCT) suggest~     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better~     effect on overall mortality than later MV. These results suggest that MV has a non-measles~     related beneficial effect on child survival.~      Objective: To evaluate in a two-site RCT the effect on child survival and other health~     indicators of a two-dose measles vaccination schedule by providing an additional dose of~     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard~     measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina~     Faso. The investigators will test a 40-43% reduction of mortality at each site separately~     and a 32% reduction overall. Based on the results from the RCT, the investigators will~     assess the cost-effectiveness of the intervention.~      Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance~     System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations~     will be collected regularly through home visits and health centre registers. Four weeks~     after having received the third dose of pentavalent vaccine (Penta3), the children will be~     eligible for enrollment in the trial if they are not severely ill. Eligible children will be~     invited to take part in the trial. Provided parental informed consent is given, the children~     will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will~     be based on consumption of services and average cost per unit. The incremental cost~     effectiveness ratio will be calculated.~      Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each~     site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The~     children will be followed for survival and hospitalisations to 3 years of age or to the end~     of the study after three years. The investigators will analyse the effects by site and~     combined; by sex and season; possible interactions with other interventions like campaigns~     with drugs, vaccines or micronutrients will be explored.~      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of~     maternal antibody levels on subsequent antibody responses to MV. The children will be~     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.~   "
107841|NCT01644708|"~     Overweight and obesity put an heavy burden over people's health. Many methods are reported~     in medical literature but none of them proved to be effective in maintaining the results~     achieved over time. Motivational change remains a fundamental step towards the maintenance~     of a new lifestyle. Strengthening personal capabilities and self-esteem seem to be key~     strategies in motivating persons for change and facilitating a capacity of coping.~      The aim of this study is to observe the effects of an individual empowerment program on the~     health of a group of overweight/obese persons.~   "
107842|NCT01644695|"~     Abdominal wall incisional hernia is a common finding in patients who have undergone previous~     intra-abdominal surgeries. Common methods of abdominal fascial closure include primary~     closure, mesh inlay versus onlay, with or without component separation. All these methods~     have been shown to have recurrence rates for hernia between 3%-60% in the literature. The~     study describes the investigators innovative and preferred method for reconstruction of the~     abdominal wall as BARS (bony anchoring reinforcement system). This method manages the~     abdominal fascial integrity to reduce the recurrence of incisional hernia while providing an~     aesthetically superior abdominal wall contour.~   "
107843|NCT01644682|"~     Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To~     control the disease in these three countries a National kala-azar elimination program is~     ongoing. One of the major pillars of the elimination program is VL vector control. Currently~     there is a no public VL vector control program in Bangladesh. In India the program is~     depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on~     Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles~     related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector~     control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable~     for the success of national kala-azar elimination program in these three countries.~      Through current research activities we will compare the effectiveness of three effective VL~     vector control methods. They are 1) Plastering of household walls with lime (a traditional~     method known in the study areas),treatment of possible sand-fly breeding places with lime~     and bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main~     living room(s) of households; 3) Impregnation of existing bed-nets with slow release~     insecticide tablet containing deltamethrin.~      The study finding will be important for the national elimination program of the three~     countries through discovering the most effective VL vector control method.~   "
107844|NCT01644669|"~     The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System~     when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the~     Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when~     used as stand-alone radiation treatment in breast conserving therapy in women with early~     stage breast cancer.~   "
107845|NCT01644656|"~     The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific~     type of ultrasound) in assessing the pressure of the portal vein (the major vein passing~     through the liver) and the amount of liver fibrosis in patients with chronic liver disease.~   "
107846|NCT01644643|"~     To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with~     complicated urinary tract infections and complicated intra-abdominal infections.~   "
107847|NCT01644630|"~     The aim of this study is to test whether or not the use of screw-retained implant crowns on~     customized zirconia abutments results in biological, technical and esthetic outcomes similar~     to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both~     made with a computer-aided design and manufacturing procedure (CAD/CAM).~      The null-hypotheses is that marginal bone level change is equal at screw-retained and~     cemented crowns~   "
107848|NCT01644617|"~     The purpose of this study is to evaluate the dose-related effectiveness, the safety and the~     tolerability of MK-8237, compared to placebo, in the treatment of house dust mite~     (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is~     that administration of MK-8237, compared to placebo, results in dose-related improvement in~     the average total nasal symptom score (TNSS) determined during environmental exposure~     chamber (EEC) challenge.~   "
107849|NCT01644604|"~     The objective of this study is to demonstrate that the MDT-2211 renal denervation system is~     a safe and effective treatment for uncontrolled hypertension subjects despite treatment with~     3 or more anti-hypertensive medications of different classes, of which one must be a~     diuretic, as best available antihypertensive therapy~   "
107850|NCT01644591|"~     The goal of this clinical research study is to find out if stereotactic radiosurgery (SRS)~     can control the disease in patients with more than 3 melanoma brain tumors.~      SRS is the delivery of focused, high-dose radiation given in a single session to the tumors~     with a minimal dose given to uninvolved areas of the brain.~   "
107851|NCT01644578|"~     This research study is being done to look at a new MRI imaging software, Siemens~     Interventional Software, to see if we can improve our ability to see and treat cancerous~     tumors.~   "
107852|NCT01644565|"~     The purpose of the study is to determine if immunization with a chimeric E. coli protein,~     dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the~     skin.~   "
107853|NCT01644552|"~     Patients with aniridia have positive angle kappas.~   "
107854|NCT01644539|"~     The amount and kind of food which is ingested influences the regulation of meal size. Neural~     signals from the gastrointestinal tract travel via the vagus nerve to the brainstem and~     thalamus, which projects to the rest of the brain, in particular the hypothalamus, amygdala~     and primary sensory cortices. In neuroimaging studies in which the stomach was distended~     with a gastric balloon activation was observed in the right insula, left posterior amygdala,~     left posterior insula, left inferior frontal gyrus and anterior cingulate cortex. So far, no~     study has examined the effects of the ingestion or infusion of a food on the brain. In~     addition to neural signals, hormonal signals are important for meal termination. Hormones~     like insulin, ghrelin and cholecystokinin interact with gastric as well as sensory signals~     in the process of satiation, which ultimately leads to meal termination. The aim of this~     study is to investigate the interaction between food administration, hormone responses and~     brain responses. To this end an oral or intra-gastric load will be administered while~     measuring brain activity (functional magnetic resonance imaging) and hormone concentrations.~     Subjects will participate in one trainings session and in three functional magnetic~     resonance imaging (fMRI) sessions (35-min fMRI scan). A training session will take~     40-minutes and consists of placing a naso-gastric tube and ingesting 500 ml of chocolate~     milk orally. The fMRI sessions will consist of three conditions: in condition one (A) 500ml~     of chocolate milk will be administrated orally. In condition two (B) and three (C) an~     intra-gastric load of 500 ml is administrated.~   "
107855|NCT01644526|"~     The ability to selectively control blood flow through an arteriovenous (AV) graft only when~     it is needed for dialysis may reduce the current repetitive complications such as~     thrombosis, venous hypertension and blood steal from the extremities. The Hemoaccess Valve~     System (HVS) allows an AV graft to be turned on to blood flow when it is needed for dialysis~     then when dialysis is concluded, the device's valves are activated, shutting off the flow of~     blood through the graft. The graft is then flushed with sterile saline using the dialysis~     blood lines. By having only saline in the graft and restoring normal blood flow to the~     artery and vein, it is believed that this will dramatically reduce the current complications~     with having blood diverted through the graft 24/7.~   "
145674|NCT01147757|"~     Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic~     consumption in pediatric laparoscopic ureteroneocystostomy.~   "
107858|NCT01644487|"~     The objectives of this study are to compare directly conventional balloon angioplasty alone~     versus. balloon angioplasty with routine stenting - that is, to determine whether~     angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in~     the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by~     collecting and analyzing the cases of each patient group in a prospective multicenter~     randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical~     effects of angioplasty with self-expanding stent in the infrapopliteal arteries.~      Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in~     critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior~     to conventional PTA in the aspect of vascular restenosis rate.~   "
107859|NCT01644474|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in~     comparison with ezetimibe after 24 weeks of treatment in participants with~     hypercholesterolemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other~          time points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
107860|NCT01644461|"~     This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous~     Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study~     is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle~     Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile~     and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in~     photographic assessment, Physician's assessment scores, Patient's assessment scores form~     enrollment to end of study.~   "
107861|NCT01644448|"~     This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of~     Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is~     being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self~     assessment score. The secondary endpoints are improvement in photographic assessment form~     randomization to end of study.~   "
107862|NCT01644435|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy~     of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted~     at 2 centers in India. The primary endpoint is change in the Global Acne scarring~     classification scores from screening to end of the study. The secondary endpoints are~     Photographic Assessment, Physicians assessment score and Patients self assessment score.~   "
107863|NCT01644422|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy~     of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair~     transplantation. The study is being conducted at 2 centers in India. The primary endpoints~     are Increase in Hair Follicle viability after transplant, Improvement in Caliber & Density~     of hair and Improvement in Photographic assessment from randomization to end of study. The~     secondary endpoints are Physicians and Patients self assessment score.~   "
107864|NCT01644409|"~     Long term open label study on safety and durability of the Urgent-SQ tibial implant device~     for refractory overactive bladder syndrome (OAB).~   "
107865|NCT01644396|"~     This is an open-label study designed to establish the safety and effectiveness of adalimumab~     in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.~   "
107866|NCT01644383|"~     Logotherapy has never been evaluated in HIV-infected teenagers. In this study, we will~     evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy~     in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn~     Memorial Hospital.~   "
107867|NCT01644370|"~     To explore allergen-specific effector and regulatory T cell response in HIV-infected~     children before and after HAART initiation~   "
107868|NCT01644357|"~     Only a few well-designed studies have investigated the effect of pharmaceutical care on~     asthma patients and to date there are no published studies investigating this effect~     specifically on severe and refractory asthma.~      The objective of this study is evaluate the effect of pharmaceutical care on asthma control~     and quality of life (QoL) of patients with severe or refractory asthma compared with~     pharmacist dispensation only.~   "
107869|NCT01644344|"~     The standard post-operative radiographic protocol for the monitoring of fractures at HSC~     includes post-operative in hospital radiographs as well as radiographs at the two week~     follow up appointment. This is in addition to good quality intra-operative radiographs. With~     current operative techniques and implants, orthopaedic surgeons can achieve reliably stable~     internal fixation. In fact, patients are often allowed to take weight through the fractured~     limb immediately post-operatively. In these cases, redundant post-operative radiographs~     likely represent an avoidable cost to the system financially, and an avoidable cost to the~     patient in additional time spent in hospital and unnecessary radiation exposure.~   "
107870|NCT01644331|"~     The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular~     treatment received for shortness of breath due to heart failure will work better than the~     regular treatment alone. The study will also look to see if other symptoms of heart failure~     or problems associated with heart failure treatments, like changes in kidney function, are~     affected by tolvaptan.~      The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will~     be more effective at relieving dyspnea than fixed dose furosemide alone.~   "
107871|NCT01644318|"~     The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with~     autoimmune thyroiditis and habitual abortions~   "
107872|NCT01644305|"~     The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their~     association with bone and cardiovascular parameters in patients with Polycystic Ovary~     Syndrome.~   "
107873|NCT01644292|"~     The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills~     home training program for older adults in preparation for a third phase feasibility study.~   "
108347|NCT01638052|"~     The investigators goal is to determine the efficacy and duration of analgesia with the~     addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine,~     of the great auricular nerve in children undergoing tympanomastoid surgery.~   "
107874|NCT01644279|"~     The age-related loss of muscle mass and strength, also termed sarcopenia, is a commonly~     recognized consequence of aging and has been associated with frailty, functional loss,~     hospitalization, and increased mortality among older people. Sarcopenia and its consequences~     have a considerable economic impact, since it has been estimated that the healthcare cost~     attributable to sarcopenia in the US in 2000 was $ 18.5 billions. Preclinical animal models~     strongly suggest that apoptosis, a programmed cell death, might play a prominent role in the~     age-related muscle wasting. In specific aim one, the investigators will assess the extent of~     muscle apoptosis in muscle biopsies obtained from the vastus lateralis muscle of young~     control subjects (ages 20-35) and high-performance and low-performance older subjects (age~     range 70-99 years). In specific aim 2, the investigators will investigate the role of Poly~     (ADP-ribose) polymerase 1 (PARP-1) and apoptosis-inducing factor (AIF) in the induction of~     skeletal muscle apoptosis. In specific aim 3, the investigators propose to investigate the~     contribution of the muscle energy deficit, due to the age-related mitochondrial dysfunction,~     in the development of muscle wasting. Finally, in specific aim 4, the investigators propose~     to reassess after four years physical performance, muscle mass and the extent of muscle~     apoptosis, in the high-performing participants, in order to correlate eventual decline in~     physical function, muscle mass and functional status, with changes in muscle apoptosis and~     in biochemical parameters in this very old population. Physical performance will be~     established according to the summary performance score obtained in the Short Form Physical~     Performance Battery (SPPB). In addition to the SPPB the investigators will also employ hand~     grip strength and knee extensor strength tests and the investigators will quantify muscle~     contractile area using 3D magnetic resonance imaging. Disability will be assessed using a~     self-report questionnaire. These studies will enhance our understanding of the biology and~     pathophysiology underlying the geriatric syndrome of sarcopenia and provide significant and~     novel insights that will enable us to identify new potential targets for interventions aimed~     at preventing and treating sarcopenia and functional impairment in older adults.~   "
107875|NCT01644253|"~     The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when~     administered in combination with rituximab or obinutuzumab, in combination with idelalisib~     and rituximab, or in combination with ibrutinib in patients with chronic lymphocytic~     leukemia (CLL).~   "
107876|NCT01644240|"~     This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy~     adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy~     elderly subject population is included to evaluate the safety, tolerability, and PK of~     TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for~     all cohorts will be conducted within 21 days before the first dose.~   "
107877|NCT01644227|"~     Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip~     arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.~      Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk~     but increase the incidence of postoperative infection.~   "
107878|NCT01644214|"~     Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are~     commonly used in conservative treatment. Despite their prevalence, there is no literature to~     guide the management of pessaries. Our objective is to determine whether patients managed~     with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if~     there is any difference in complications rates between the two groups.~      Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in~     the group randomized to 6 month follow-up intervals and that there will be no difference in~     complication rates between the two follow-up groups.~      Method: The investigators will conduct a prospective randomized control trial comparing~     patient satisfaction and complication rates between patients with pessaries randomized to~     either 3 or 6 month follow-up intervals over 1 year.~   "
107879|NCT01644201|"~     One out of two adults in Canada is currently overweight and therefore at increased risk for~     a number of medical conditions including diabetes, high blood pressure, heart attacks and~     stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre,~     suggesting that fibre intake could play an important role in prevention and progression of~     obesity and diabetes and other conditions. Several studies have suggested that fibre has a~     positive effect on blood sugar and may help lower body weight.~      The purpose of this study is to help better understand the effect of adding fibre~     supplementation to a low calorie diet on blood sugar control and weight loss. The~     investigators hypothesize that blood sugar control will improve in participants in the fibre~     supplementation group.~      Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months),~     between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can~     participate in this study.~   "
107880|NCT01644188|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable maximally tolerated daily statin therapy in comparison with~     ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high~     cardiovascular (CV) risk.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other~          time points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
107881|NCT01644175|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein~     convertase subtilisin/kexin type 9 (PCSK9).~      Primary Objective of the study:~        -  To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by~          alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or~          without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks~          of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effect of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
107882|NCT01644162|"~     The aim of this study is to determine whether respiratory disease exacerbations (a sudden~     worsening of symptoms) can be predicted by variables that are monitored by non-invasive~     ventilators (small machines that assist breathing) in patients requiring long term home~     ventilation.~      The investigators hypothesise that acute exacerbations of patients with respiratory disease~     and ventilatory failure will be predicted by changes in the respiratory variables monitored~     and stored by ventilators during chronic home ventilator use.~   "
107883|NCT01644149|"~     The primary objective of this study was to evaluate if administration of a seasonal flu~     vaccine using a jet injector device is comparable to traditional needle and syringe delivery~     for eliciting an immune response. A secondary objective was to compare the safety of the two~     delivery methods.~   "
145705|NCT01147354|"~     The aim of this study is to evaluate the effect of selenium supplementation on oxidative,~     inflammatory and nutritional markers in hemodialysis patients.~   "
107884|NCT01644136|"~     This study is being performed to investigate if the application of Arista absorbable~     hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles.~     Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection~     for cancer. These fluid collections can become symptomatic in some patients. Arista would be~     applied to one side of the pelvis after a pelvic lymph node dissection, to see if this~     decreases the number of postoperative lymph fluid collections seen on a computed tomography~     (CT) scan after surgery~   "
107885|NCT01644123|"~     Spasticity is a condition that results from damage to the central nervous system and causes~     painful muscle contractures that drastically affect level of independence, activities of~     daily living, and quality of life. Although there are well-known and accepted treatments for~     spasticity, spasticity is often left undertreated; the specific reasons for this observation~     are unknown. Because there is no blood test or scan that indicates the presence of~     spasticity, diagnosis is based entirely on physician impression. Therefore, the~     investigators hypothesize that one reason that spasticity is undertreated is due to the lack~     of a standardized diagnostic procedure. This study attempts to test the reliability of a~     diagnostic flowchart that seeks to increase the accuracy of physician diagnosis of~     spasticity.~   "
107886|NCT01644110|"~     The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of~     oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.~   "
107887|NCT01644097|"~     This randomized phase II clinical trial studies probiotic supplementation in preventing~     treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may~     help prevent diarrhea caused by treatment with chemotherapy.~   "
107888|NCT01644084|"~     It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary~     bypass (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin~     decreases coagulopathy, platelet aggregation, immune responses. However the use of albumin~     is limited, because it is expensive and can rarely cause infection.~      Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently~     developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA~     et al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced~     impairment in fibrin formation and clot strength in thromboelastometry tracings.~      Coagulopathy is directly related to bleeding and massive postoperative bleeding increases~     the risk of reoperation. Therefore it is important to avoid administration of fluids that~     can inhibit homeostasis after CPB.~      The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of~     priming solution on coagulation compared to 5% HA.~   "
107889|NCT01644071|"~     Aggressive behavior (AB) is a major burden to society with severe socio-economic~     consequences. Genetic studies suggest a high heritability of AB; in particular, the low~     expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent~     neural aggression models have suggested a dysfunctional emotion regulation circuit including~     amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT)~     projections from the anterior cingulate cortex to the amygdala have been suggested to~     promote aggressive behavior. This finding is well in line with the observation that the~     MAOA-L allele leads to a reduced expression of monoamine oxidase A and thus to an overflow~     of 5-HT in serotonergic cortico-amygdalar projections. However, due to methodological and~     ethical constraints, the neural substrates of AB are difficult to assess. A possible~     solution is the use of virtual violence which permits AB against virtual characters without~     direct consequences for any real person and can be easily applied in functional imaging~     experiments. There is evidence that virtual and real aggression share common neural~     substrates. AB in violent video games inhibits rostral anterior cingulate cortex (ACC) and~     amygdala in line with the suggested neurophysiological circuits underlying real-life AB.~   "
107890|NCT01644058|"~     Patients will be satisfied with the immediate loading protocol of two implants joined to a~     complete mandibular overdenture.~   "
107891|NCT01644045|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     respiratory emergencies, when paramedics are supported telemedically by an EMS physician.~   "
107892|NCT01644032|"~     The aim of the study is to evaluate the safety and efficacy of telemedically supported and~     delegated pain therapy in the Emergency Medical Service (EMS).~   "
107893|NCT01644019|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     stroke, when paramedics are supported telemedically by an EMS physician.~   "
107894|NCT01644006|"~     The aim of the study is to investigate the quality of prehospital emergency care in acute~     coronary syndromes, when paramedics are supported telemedically by an EMS physician.~   "
107895|NCT01643993|"~     Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on~     the embryos transferred, but also the conditions in the uterus at the time of transfer and~     implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin~     (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to~     secrete hCG before implantation must occur because embryos are placed into the uterus rather~     than traveling there from the fallopian tubes. Recent studies have shown that the~     introduction of hCG into the uterus prior to embryo transfer may make the uterus more~     receptive to implantation. These studies involved day 3 embryos and the investigators are~     seeking to evaluate the potential benefits of hCG on implantation rates of blastocysts (day~     5 or day 6 embryos).~      The purpose of this study is to determine whether infusion of human chorionic gonadotropin~     (hCG) into the uterus immediately prior to embryo transfer results in increased implantation~     rates.~      The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture~     conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be~     performed per routine.~      At the time of embryo transfer, participants will be randomly assigned to either the control~     group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL~     of transfer media including 500IU of hCG. Patients in the control group will have a mock~     embryo transfer with 20µL of transfer media.~      All post-transfer care and pregnancy monitoring will be identical and per routine protocol.~   "
108596|NCT01634815|"~     Evaluation of a new biological criterion, the local capillary blood lactates to optimize the~     management of patients with chronic critical ischemia requiring revascularization fast.~     Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent~     ischemia in a limb revascularized.~   "
107896|NCT01643980|"~     The preterm birth is considered as a main problem in the modern obstetrics, being the~     responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the~     significant medical advances, the rate of prematurity has not declined over the past 40~     years and even continues to rise in the developed countries. In order to decrease the~     prematurity is necessary that two premises: to identify the pregnant women at risk of~     preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and~     therefore avoid preterm delivery. The investigators propose a clinical trial with the~     objective to identify effective strategies to reduce the premature birth (34 weeks and~     earlier) rate in the population of pregnant women at risk for premature birth, which will be~     identified by ultrasound during the second trimester of their pregnancy.~      The investigators intend to compare two accepted strategies: administration of progesterone~     (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy~     to apply, and they present very few maternal-fetal secondary effects.~   "
107897|NCT01643967|"~     This is a open, phase III, multicenter, prospective, comparative, controlled, randomized~     clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon~     Medplus device versus conventional therapy in treating patients with diabetic foot.~   "
107898|NCT01643954|"~     This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.~   "
107899|NCT01643941|"~     This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of~     a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose~     level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). The main goal of the study is to~     determine how safe and well tolerated the vaccine is as well as to describe the immune~     response elicited by the vaccine in healthy adults aged 65 to <86 years. In addition, the~     study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the~     Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to~     <86 years.~   "
107900|NCT01643928|"~     This extension study will evaluate the safety (including immunogenicity) of treatment with~     rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from~     rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued~     treatment access to subjects with active rheumatoid arthritis who have participated for at~     least 16 weeks in other studies in the rituximab Pfizer program.~   "
107901|NCT01643915|"~     The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric~     patients during dental treatment improves when a cartoon film is viewed or a videogame is~     played as methods of distraction.~   "
107902|NCT01643902|"~     The primary objective of this study is to evaluate the safety of intravenous tPA in patients~     waking up with symptoms of acute stroke and presenting to the ED within 4.5 hours from~     awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.~      The hypothesis is that patients that wake up with stroke symptoms may have developed the~     stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the~     ED within that time, therefore IV tPA should be safe and effective in this population.~   "
107903|NCT01643889|"~     The purpose of this study is to assess the effects of single and multiple doses of~     domperidone on the QTc interval duration in healthy adult volunteers at domperidone doses of~     10 mg four times a day (q.i.d.) and 20 mg q.i.d.~   "
107904|NCT01643876|"~     Palatal brushing has several advantages including removal of debris and stimulation of blood~     flow and saliva, which may help to prevent or treat oral diseases, such as denture-related~     stomatitis in complete denture wearers.~      However, there is no previous clinical trial testing this effect. Therefore, the~     investigators goal is to evaluate whether palatal brushing may change the severity of~     denture stomatitis and counts of microbes on denture and palatal mucosa.~      After an initial exam and data collection, participants will receive instructions about~     palatal brushing and they will be assessed after 1 and 3 months. Collection of data will~     include patient-reported information, intraoral photographs and swabbing (for counting~     microbes).~      Tested Hypotheses:~        -  There is no difference in the extent of palatal inflammation in edentulous patients~          with denture stomatitis before and after 3 months of palatal brushing.~        -  There is no difference in the number of colony forming unit (CFU) of Candida isolated~          from palate and denture of patients affected by denture stomatitis before and after 3~          months of palatal brushing.~   "
107905|NCT01643863|"~     This multi-center observational study will evaluate the use of RoActemra/Actemra~     (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients~     initiated on RoActemra/Actemra treatment according to the licensed label will be followed~     for 6 months.~   "
107906|NCT01643850|"~     This study, designed as a proof of concept study of MCS110 in pigmented villonodular~     synovitis, will assess the clinical response to MCS110 treatment in Pigmented Villonodular~     Synovitis (PVNS) and Giant cell tumor of the tendon sheath (GCTTS) patients after multiple~     intravenous doses of MCS110 using magnetic resonance imaging to assess tumor volume, and to~     evaluate pharmacokinetics/pharmacodynamics, safety and tolerability in this population.~   "
107907|NCT01643837|"~     There are many current medical treatments for mastalgia, but few have been proven effective.~     Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as~     compared to a light touch protocol and standard management in the treatment of women with~     cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the~     pain and the effect of the pain on quality of life.~   "
107908|NCT01643824|"~     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy~     (PBT) for HCC patients in hepatitis B endemic area.~   "
107909|NCT01643811|"~     The purpose of this study is to determine whether the extent of gastrectomy and anastomosis~     type affect chronic metabolic disease such as diabetes and hypertension in early gastric~     cancer patients.~   "
107910|NCT01643798|"~     Studies have shown that transcranial magnetic stimulation (TMS), a non-invasive form of~     brain stimulation, can reduce pain in the laboratory and in the clinic. The purpose of this~     study is to investigate how TMS relieves pain and affects pain circuitry in the brain. One~     of the primary study hypotheses is that opioid blockade will significantly reduce the pain~     relief produced by left prefrontal cortex TMS.~   "
108597|NCT01634802|"~     The purpose of this study is to determine whether the use of a Computerized Decision Support~     System (CDSS) in form of alerts to clinicians enhances early detection of immunological~     treatment failure in HIV patients.~   "
107911|NCT01643785|"~     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a~     reduction in mucus viscosity. As part of the search for more effective forms of therapy~     against H. pylori when it colonizes not only the surface of the surface mucosal cells but~     also the surface mucous gel layer covering the mucosal surface of the stomach. The~     investigators decided to investigate whether or not endonase might have additive effect of~     pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.~   "
107912|NCT01643772|"~     A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a~     multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with~     pain.It will be a single center, open label, randomized, oral administration study.~   "
107913|NCT01643759|"~     This is a single center, open label, randomized, parallel group single dose pharmacokinetic~     (PK) study.~   "
107914|NCT01643746|"~     The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV~     Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary~     goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at~     one year post implantation.~   "
107915|NCT01643733|"~     Hypothesis: The primary objective of this study is to assess whether using a flow~     measurement device, in this case the Transonics flow device, as an end-point to~     interventional treatment of diseased dialysis fistulae can help increase immediate treatment~     success in terms of quality of dialysis immediately following the treatment and increasing~     time to reintervention.~   "
107916|NCT01643720|"~     In the proposed study, the investigators would like to investigate the emotion regulation~     (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence~     parents have on their children's ER. More specifically, the investigators would like to~     examine what are the ER mechanisms that parents use, what mechanisms of self regulation~     children with autism internalize, and how parents support and improve the ER capabilities of~     their child with ASD. These will be studied in a behavioral level, using micro-analysis of~     parent-child interaction, and in a physiological level, using indexes of stress control and~     affiliation. In addition, in order for parental ER support to be effective, it is important~     to consider more innate neuro-developmental difficulties children with ASD demonstrate that~     strongly affect their ability to regulate themselves. These include sensory regulation~     difficulties, temperament, attention disorders and poor executive functioning.~      Hypotheses:~        1. ER strategies used by children with ASD will be more poorly developed and less~          effective, compared to those of children in the control groups.~        2. Difficult temperament and sensory regulation difficulties will hamper ER in children~          with ASD.~        3. ER strategies of parents of children with ASD will be more poorly developed and less~          effective than those of parents in the control groups.~        4. Good parental self-ER and parental attunement to the child will be predictive of~          improved ER in children with ASD, and in parent-child synchrony, both in the behavioral~          and in the physiological levels.~   "
107917|NCT01643707|"~     Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)~      The study is expected to provide evidence to support claim(s) that:~        -  Education and process improvement initiatives can improve the diagnosis of and~          appropriate therapy application for sinus node dysfunction (SND)~        -  The quality improvement methods studied have general applicability and can be used by~          all centers~        -  Appropriate treatment minimizes caregiver burden~        -  Appropriate treatment improves quality of life (QOL) and functional status compared to~          pre-implant~   "
107918|NCT01643694|"~     To determine if physicians who complete brief tasks intended to promote meaning in work and~     job satisfaction, foster teamwork and social support at work, nuture personal relationships~     and work-life balance, recognize and build on personal strengths, encourage effective~     problem solving, and promote positive emotions have improved resilience, meaning in work,~     and engagement at work.~   "
107919|NCT01643681|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     lumbar intervertebral disc degeneration.~   "
107920|NCT01643668|"~     This research is a phase II clinical trial. Phase II clinical trials test the effectiveness~     of an investigational intervention to learn whether it works in treating a specific cancer.~     Investigational means that the study intervention is still being studied and that research~     doctors are trying to find out more about it. It also means that the FDA has not yet~     approved this study intervention for your type of cancer.~      All participants on this study are treated in an identical manner. The investigators are~     doing this study because there continues to be a significant risk of relapse of disease~     after reduced intensity transplantation. In studies which have compared transplants using~     high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients~     undergoing reduced intensity transplants appear to have higher rates of relapse, but lower~     rates of toxicity and complication. This study attempts to utilize clofarabine, a newer~     chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor~     effects of the conditioning regimen without accumulating unacceptable toxicity.~      The reduced intensity allogeneic stem cell transplantation procedure involves giving you~     chemotherapy in relatively less intense doses to suppress your immune system. This is~     followed by an infusion of healthy blood stem cells from a matched related donor or a~     matched unrelated volunteer donor. It is hoped that these donor cells can eventually then~     attack any cancer cells which remain.~      In this research study, the investigators are looking to see how well this new combination~     of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation.~     By works the investigators mean to analyze safety, ability of donor cells to engraft (take~     hold), as well as measures of complications including toxicity, infections, graft-vs-host~     disease (GVHD), and relapse.~   "
107921|NCT01643655|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     avascular necrosis of the femoral head.~   "
107922|NCT01643642|"~     This study compares both clinical effectiveness and cost-effectiveness of a brief,~     intensified therapy and diagnostic method for patients with mood and/or anxiety disorders~     with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the~     Netherlands.~   "
107923|NCT01643629|"~     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy~     of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being~     conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density~     of hair and Improvement in Photographic assessment from randomization to end of study. The~     secondary endpoints are Physicians and Patients self assessment score.~   "
107924|NCT01643616|"~     For distal sciatic nerve block this prospective, randomised comparison with ultrasound~     guided distal subepineural block tested the hypothesis, that intraepineural injection of~     local anesthetic using nerve stimulation technique is common and associated with high~     success rate.~   "
107925|NCT01643603|"~     This study uses a drug called dasatinib to produce an anti-cancer effect called large~     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as~     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause~     large granular lymphocyte expansion to happen in patients who have received a blood stem~     cell transplant (SCT) between 3 to 15 months after the SCT. In this research study,~     researchers want to find how well dasatinib can be tolerated, the best dose to take of~     dasatinib and how to estimate how often large granular lymphocytic cellular expansion~     happens at the best dose of dasatinib.~   "
107926|NCT01643590|"~     This is a randomized, double-blind, placebo controlled Phase II study is designed to assess~     the safety and efficacy of using JVS-100 to treat heart failure.~   "
107927|NCT01643577|"~     Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of~     nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but even more~     often it occurs in otherwise healthy individuals. The symptoms of gastroparesis can~     significantly alter a patient's quality of life. Current therapies are limited. In this~     study, the investigators seek to determine if twice weekly acupuncture treatments can~     improve symptoms of gastroparesis.~   "
107928|NCT01643564|"~     Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft~     dysfunction.~   "
107929|NCT01643551|"~     An observational study of neuron specific enolase, as a marker of reperfusion injury, in~     LVAD recipients before and following VAD implantation.~   "
107930|NCT01643538|"~     The goal of this randomized and controlled trial is to test whether a financial incentive of~     a donation to achieve a social goal is more effective to motivate and sustain a daily~     walking habit than the same dollar value given to an older adult. The investigators will~     achieve this using a novel computer platform utilizing a digital pedometer-internet~     interface.~   "
107931|NCT01643525|"~     That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity~     to hyper acute ischemic stroke than does CT.~   "
107932|NCT01643512|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United~     States. The cause of NAFLD is poorly defined but is thought to involve complex interactions~     of genetic and environmental factors. NAFLD is often associated with the traits of the~     metabolic syndrome including diabetes, high cholesterol or elevated blood pressure.~     Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious~     form which includes inflammation that may lead to severe scarring in the liver. The goal of~     this study is to evaluate shared genetic factors that underlie NAFLD and features of the~     metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins~     and first degree relatives.~   "
107933|NCT01643499|"~     This study is being done to determine the dose of a chemotherapy drug (irinotecan~     [irinotecan hydrochloride]) that can be tolerated as part of a combination of drugs. There~     is a combination of chemotherapy drugs often used to treat gastrointestinal cancer, which~     consists of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin~     and is known as FOLFIRINOX. FOLFIRINOX is a current drug therapy combination (or regimen)~     used for people with advanced pancreatic cancer, although this combination is not Food and~     Drug Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a~     separate clinical trial to increase survival compared to another commonly used drug in~     pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with~     other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer,~     esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer,~     and cancers with an unknown primary location. The best dose of irinotecan to use in~     FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho [UDP]~     glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] gene) of subjects for the presence~     of an alteration in that gene, which may affect how the body handles irinotecan. Genes help~     determine some of the investigators individual characteristics, such as eye color, height~     and skin tone. Genes may also determine why people get certain diseases and how medicines~     may affect them. The result of the genetic analysis will divide subjects into one of three~     groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose~     of irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of~     irinotecan. Group C (approximately 10% of subjects) will receive an even lower dose of~     irinotecan~   "
107934|NCT01643486|"~     Hypothesis: The use of a program that assists with selection of the appropriate number of~     phosphate binders for a meal based on patient specific factors will result in improved serum~     phosphate control, a reduction in overall number of phosphate binders used and enhanced~     patient satisfaction.~      Primary Aim: To determine if teaching patients to use a 'phosphate counting' program~     installed on an iTouch that selects the appropriate amount of phosphate binder to be taken~     with each meal is associated with better phosphate control than usual care.~      Research Plan: There will be 3 phases to the study. Phase 1: Recruitment of 60 peritoneal~     dialysis (PD) patients. The information generated from this phase will be used to develop~     the iTouch program for phosphate counting and matching binder number. Phase 2: iTouch~     program once developed will be pilot tested on a convenience sample of 10 PD patients and~     modified if required. Phase 3: Randomized controlled trial of 92 PD patients to determine if~     using the iTouch phosphate counting program reduces serum phosphate compared to controls.~     Success would be based on seeing a statistically significant difference in serum phosphate~     as expected from our sample size calculation~   "
107935|NCT01643473|"~     The purpose of this study is to to culturally tailor a technology-based individualized~     adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are~     non-adherent to their medications, and determine its acceptability.~   "
107936|NCT01643460|"~     The purpose of this study is to track outcomes and complications of patients at IUMC~     referred by physicians for EUS-guided pancreatic cyst ablation. This information is~     essential in order to disseminate future published information to physicians about this~     technique. A database will be created to track these patients undergoing an already~     scheduled/planned procedure. Phone calls at selected intervals will be made following the~     procedure to track any complications that occur~   "
107937|NCT01643447|"~     The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it~     can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that~     Ulinastatin can improve survival in HCC patients or not.~   "
107965|NCT01643083|"~     Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people~     in the community. However, results of current pharmacological treatment on functional~     dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been~     used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating~     and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst~     there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators~     test whether rifaximin is also effective in curing post-prandial distress symptoms related~     to dyspepsia.~   "
107938|NCT01643434|"~     Resistant hypertension (ReHy) is an emerging clinical and public health problem which tends~     to increase because populations are living longer and there is a growing global epidemic of~     obesity, diabetes and sleep apnea. It is also tempting to speculate that the excessive~     dietary salt ingestion reported in many countries can contribute substantially to the risk~     of ReHy development. ReHy is defined as persistent high blood pressure (above the target~     goal) in spite of the use of at least 3 antihypertensive agents of different classes, one of~     them must being diuretics.~      Data regarding the exact prevalence of ReHy are very limited. In addition, little data is~     available about 3-drug combinations but a simplified treatment algorithm has demonstrated~     that a combination of a diuretic plus an angiotensin-converting enzyme inhibitors (ACEi) or~     an angiotensin-receptor blocker (ARB) plus diuretic, adding a calcium channel blocker when~     necessary, controlled 64% of hypertensive patients and, in addition, was even more efficient~     than the current guideline-based management. By contrast, the fourth drug to be added-on the~     triple regimen is still controversial and guided by empirical choices or personal~     preferences. Recent studies suggest the emerging role of spironolactone as the first-line~     fourth drug for treating resistant hypertension. Conversely, because of the~     pathophysiological rationale, others have proposed the use of β-blockers or even centrally~     acting agents for managing the sympathetic hyperactivity. The present concerns about the~     limited blood pressure reducing effect of β-blockers, especially in elderly people, the~     potent effect of centrally acting agents and our personal experience are pointing to~     clonidine as the fourth drug to be added-on to a multidrug combination for reaching optimal~     blood pressure in patients with ReHy. Nevertheless, no studies have been performed~     comparing, head-to-head, which one is the best fourth drug (spironolactone or clonidine) to~     be added-on to a common used multidrug combination in order to treat this condition.~      Therefore, the principal objectives of the ReHOT Trial are to assess prospectively: (1) the~     prevalence of ReHy in a cohort of outpatients with stage II hypertension; (2) the effect of~     spironolactone on blood pressure, in comparison to clonidine, when added to a multidrug~     combination consisting of chlorthalidone plus ACEi (or ARB) plus amlodipine, all of 3~     up-titrated to the highest dose; (3) the role of measuring sympathetic nervous system~     activity and renin-angiotensin-aldosterone activity on predicting the response of blood~     pressure to spironolactone and clonidine.~   "
107939|NCT01643421|"~     The purpose of this study is to determine the effects of a deep inspiration combined to~     expiratory positive airway pressure protocol on respiratory function, quality of life,~     exercise tolerance and heart rate variability in adults with severe asthma.~   "
107940|NCT01643408|"~     This study will utilize Erwinaze via intravenous administration in patients between the ages~     of 1 and 30 who have experienced an allergy to their frontline therapy. The study will~     determine the proportion of patients with 2 day nadir serum asparaginase activity levels~     that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.~   "
107941|NCT01643395|"~     The purpose of this protocol is to prove the efficacy of vertebroplasty in patients~     suffering from acute non osteoporotic vertebral compression fracture.~      Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to~     prevent further collapse.~      Our study will compare vertebroplasty versus conservative therapy (brace).~   "
107942|NCT01643382|"~     Based on multiple prior studies, kidney transplant recipients with diabetes are at higher~     risk for poor initial graft function after transplant. Our study is designed to determine if~     tight blood sugar control around the time of kidney transplant will improve short term graft~     function.~   "
107943|NCT01643369|"~     Important health benefits of meditation may be conferred as much by what people actually do~     and say in their daily lives as by how they self-perceive the effect of training on their~     behavior and emotions. To test this hypothesis, and to explore whether specific elements of~     meditation (e.g. compassion vs. mindfulness) have different effects on real-world social~     behavior, the current project proposes to use the Electronically Activated Recorder (EAR) in~     a randomized, longitudinal design to objectively measure whether meditation does indeed make~     people behave in happier, kinder and more prosocial ways in their daily lives. This design~     will permit an exploratory analysis of how such behavioral transformations might relate to~     subjective reports of meditative effects. To accomplish these objectives, 108 medically~     healthy adults will be randomized to 8 weeks training in compassion meditation (n=36),~     Mindfulness Attention Training (MAT) (n = 36) or to an active control condition consisting~     of a health education discussion group (n=36). Prior to randomization and again upon~     completion of these interventions, all subjects will participate in an EAR protocol to~     evaluate the effect of meditation training on their real-world prosocial and affiliative~     behavior. Based on prior research and direct pilot data from 25 participants, prosocial and~     affiliative behavior will be assessed as the amount of (1) shown empathy and affection, (2)~     laughing vs. sighing, (3) arguing and complaining, (4) time spent interacting with others~     vs. alone, (5) meaningful conversations, (6) socially inclusive (i.e. use of we/us) vs.~     self-focused (i.e. use of I/me) first person language. Following the first EAR~     assessment, subjects will commence 8 weeks of compassion meditation training, MAT, or~     attendance in the health discussion group. Following these interventions subjects will~     participate in EAR monitoring identical to the initial assessment. To assess whether changes~     in daily behavior are sustained over a longer period, all subjects will undergo a final EAR~     assessment 6 months following completion of the study interventions. Self-report measures of~     social integration and support and behavioral/lifestyle variables that might be associated~     with EAR outcomes will be evaluated prior to each EAR assessment and treated as covariates.~   "
107944|NCT01643356|"~     The study will use a comprehensive behavioral intervention adapted for pregnant women to~     change dietary intake, eating behavior and physical activity. The central hypothesis of this~     study is that the intervention will reduce excess gestational weight gain and achieve~     clinical and metabolic benefits in obese and overweight pregnant women and their infants~     over the first year of life.~   "
107945|NCT01643343|"~     The purpose of this research is to study joint attention. Joint attention plays a critical~     role in social and language development in children with and without autism. Joint attention~     is the shared attention between a child and another person. This study seeks to set a~     standard benchmark of frequency scores for joint attention. Finding a rate of engaging in~     joint attention behavior would offer a benchmark for all researchers and practitioners~     working with learners with and without autism.~   "
107946|NCT01643330|"~     The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay~     heart failure related hospitalizations in persons with advanced heart failure when added to~     their maximal and optimized therapy.~   "
107947|NCT01643317|"~     Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have~     shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness~     of screening for AAA in men in the Netherlands has been demonstrated by using a Markov~     model. Screening might be even more (cost-) effective if targeted on high risk groups, such~     as patients with a particular cardiovascular disease with a known increased risk of having~     an AAA.~      Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused~     on targeted AAA screening to proactively diagnose patients at high risk of having an~     aneurysm that eventually may rupture. This pilot project aims to study the value of a~     screening protocol in daily practice to detect AAA's in high risk patients.~   "
107948|NCT01643304|"~     This field based, questionnaire study will document observational data on womens perception~     of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the~     questionnaire at one occasion.~   "
107966|NCT01643070|"~     To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus~     capecitabine, with or without prior induction chemotherapy in patients with locally advanced~     or marginally resectable rectal cancer with resectable synchronous liver metastases.~   "
107949|NCT01643291|"~     Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment~     and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged~     anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated~     radiation exposure. This investigation will evaluate lumbar punctures performed in the~     intraoperative setting by oncologists with ultrasound guidance performed by the~     anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that~     anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of~     attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.~   "
107950|NCT01643278|"~     This phase I trial studies the side effects and best dose of dasatinib when given together~     with ipilimumab in treating patients with gastrointestinal stromal tumors or other sarcomas~     that cannot be removed by surgery or have spread to other places in the body. Dasatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways by~     targeting certain cells. Giving dasatinib together with ipilimumab may be a better treatment~     for patients with gastrointestinal stromal tumors or other sarcomas.~   "
107951|NCT01643265|"~     The purpose of this study will allow us to examine how quickly and to what extent plasma~     amino acids levels rise after ingesting a single dose of either whey or albumin protein. The~     investigators anticipate that the amino acids from albumin concentrate protein will rise as~     quickly and to the same extent as amino acids from whey protein. These findings will help us~     to understand the biological availability of these proteins and efficacy of the supplement~     so that consumers may be presented with nutritional options.~   "
107952|NCT01643252|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
107953|NCT01643239|"~     The purpose of this study will employ clinical assessment tools to examine the effects of~     modified constraint-induced therapy (mCIT) on the more affected upper extremity of children~     with cerebral palsy.~   "
107954|NCT01643226|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
107955|NCT01643213|"~     The purpose of this study is to evaluate patient preference of the Boston Scientific~     Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the~     Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.~   "
107956|NCT01643200|"~     Evaluate the safety and feasibility of the Medtronic Zotarolimus stent to improve erectile~     function in males with sub-optimal response to PDE5i therapy due to atherosclerotic lesions~     of the internal iliac and/or internal pudendal arteries.~   "
107957|NCT01643187|"~     The purpose of this study is to measure the impact of a fortified food on the nutritional~     and micronutrient status of malnourished children, compared with milk. The changes to be~     evaluated include the indicators weight for height, height for age, weight for age, mid-arm~     circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic~     acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.~   "
107958|NCT01643174|"~     Within defined groups of primary malignant and benign bone and soft tissue spine tumors,~     what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with~     overall survival?~   "
107959|NCT01643161|"~     Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics.~     There is no known empirically validated treatment approach to functional symptoms. Cognitive~     Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision.~     The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as~     compared to treatment as usual (TAU) improves patient outcomes.~   "
107960|NCT01643148|"~     Objective:~      Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen~     (CA) 15-3 together as reliable biomarkers for breast cancer.~      Patients:~      Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.~      Interventions:~      Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of~     cancer and patients with benign breast disease as well as biochemical tests of leptin,~     adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC),~     high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample~     to analyze CA 15-3 levels with a electrochemiluminescence immunoassay.~      Hypothesis:~      Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect~     high risk women to develop breast cancer.~   "
107961|NCT01643135|"~     Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations~     such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few~     studies in laminectomy had conflicting results and varying in doses. The objective is to~     compare perioperative bleeding in major laminectomy between patients receive doubles doses~     of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).~   "
107962|NCT01643122|"~     Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the~     Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable,~     valid and able to detect changes over time in approximately 250 patients with mild, moderate~     or severe endometriosis confirmed by laparoscopy.~   "
107963|NCT01643109|"~     CIMT has shown great promise in helping children and adults regain lost function in a~     disabled limb by forcing its use through an intensive motor training program and~     constraining the unaffected arm with a cast. However, relatively little is known about the~     underlying mechanisms of CIMT in hemiplegic CP. This project will use an integrated~     translation model to explore neuroimaging predictors of a positive clinical response to~     CIMT.~   "
107964|NCT01643096|"~     The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac~     on the thermic effect of food, activity of sympathetic - parasympathetic system: comparison~     between warm and cold temperament people.~   "
107967|NCT01643057|"~     The purpose of this study is to explore physiological interventions and biomarkers for Apnea~     of Prematurity in newborn infants.~   "
107968|NCT01643044|"~     The purpose of this study is to lay the ground work for a fully powered clinical trial of a~     computer-delivered screener and intervention for alcohol use during pregnancy. The pilot~     study will include:~        1. Evaluation of the usefulness of handheld devices and anonymous screening for self~          report of at-risk alcohol use among pregnant women.~        2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the~          detection of at-risk drinking in pregnant women.~        3. Evaluation of the efficacy of a computer-delivered brief intervention and use of~          tailored handouts to supplement the computer-based brief intervention focusing on~          alcohol use during pregnancy.~   "
107969|NCT01643031|"~     In recent years numerous studies have shown that the response of patients to the~     anti-platelet drug clopidogrel is widely variable. Furthermore, patients who do not respond~     well to the drug (resistant) have been shown to be at increased risk to develop cardiac~     events, including myocardial infarction and mortality. It thus seems reasonable to test the~     efficacy of the drug (by platelet function tests) and modify treatment accordingly. However,~     a large study that examined a strategy of routine testing of clopidogrel response in~     thousands of patients (GRAVITAS study) did not show any clinical benefit. This study was~     limited, however, by a very low event rate (2.3%), and by the strategy employed to treat~     patients with low response (increasing the clopidogrel dose), which is currently known to be~     ineffective in many patients with low response. To overcome these limitations the~     investigators plan to examine a high risk population - patients with diabetes planned to~     undergo coronary angiography - and to treat clopidogrel low responders by switching their~     treatment to the potent anti-platelet drug ticagrelor, which has been shown to overcome~     clopidogrel low response.~      The investigators hypothesize that patients with diabetes and low response to clopidogrel~     will benefit clinically from switching therapy to ticagrelor. The main endpoint of the study~     will be the risk of myocardial enzyme elevation following percutaneous coronary intervention~     (PCI); a marker which has been strongly associated with poor clinical outcome.~      The aim of the study is, therefore, to assess whether a strategy of monitoring platelet~     function during clopidogrel treatment in patients with diabetes undergoing PCI, and~     modifying treatment to ticagrelor in patients with low response, will be associated with~     reduced risk of myocardial enzyme release.~      The investigators plan to enroll patients with treated diabetes, planned to undergo coronary~     angiography. Patients with acute or recent myocardial infarction will be excluded. They will~     be tested for response to clopidogrel by the VerifyNow P2Y12 assay (either on chronic~     clopidogrel treatment or 12-24 hours after receiving 300 mg clopidogrel). Patients with low~     response to clopidogrel (≥ 208 PRU) will be randomized to either continued treatment with~     clopidogrel (75 mg/day), or switching of treatment to ticagrelor (90 mg twice a day) for 30~     days (followed by continued clopidogrel therapy). The primary endpoint will be the rate of~     troponin of CK-MB (cardiac enzymes) measured 20-24 hours after the PCI. Secondary endpoints~     will be the occurrence of adverse clinical endpoints - myocardial infarction, need for~     urgent revascularization or mortality at 30 days. The investigators aim to enroll 100~     patients in each study group (ticagrelor vs. continued clopidogrel). Assuming a clopidogrel~     low response rate of 40% among patients with diabetes, about 500 patients would have to be~     screened to identify 200 patients with low response.~   "
107970|NCT01643018|"~     Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the~     metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing~     extensive organ damage and even death of the patient.~      Echinococcosis is one of the most neglected parasitic diseases and the lack of the~     prospective randomised studies supports this idea. Development of new drugs and other~     treatment modalities receives very little attention, if any. In most developed countries,~     Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and~     is found almost exclusively in migrants from endemic regions. In endemic regions,~     predominantly settings with limited resources, patient numbers are high.~      The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure~     of the disease. It has to be done with a minimal risk and maximum comfort for the patient,~     and always paying attention to avoid complications, secondary hydatidosis, and relapses.~      There are several treatment modalities. Of them the most preferred surgical method is~     traditional cyst management through a laparotomy incision. Same can be done with~     laparoscopy. In the past 15 years significant advances in laparoscopic surgical skills and~     techniques combined with explosive advances in laparoscopic technology have encouraged the~     application of laparoscopy to the evaluation and treatment of solid organs including the~     liver. There are many studies about the laparoscopic treatment of liver hydatid cyst~     published in the literature and the feasibility of this procedure has been demonstrated by~     them. While the majority of them are case reports or case series, there are some relatively~     large series comparing open versus laparoscopic surgery published in the last decade, which~     all are not randomized trial.~   "
107971|NCT01643005|"~     This study seeks to develop, implement, and assess an innovative 15-session couple-based~     intervention to be delivered in a group format to young parents that aims to strengthen~     relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce~     HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships,~     and improve parenting among young parenting heterosexual couples.~   "
107972|NCT01642992|"~     The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in~     coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in~     Korea, a total of 2,873 patients were enrolled in this database between January 2003 and~     December 2009.~      The aim of the study was to investigate long-term clinical results and predictors of adverse~     outcomes after percutaneous coronary intervention with drug-eluting stents for coronary~     bifurcation lesions in South Korea.~   "
107973|NCT01642979|"~     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is~     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in~     patients with classic paroxysmal nocturnal hemoglobinuria.~   "
107974|NCT01642966|"~     This is a prospective, randomized, single-blind, investigator-initiated, crossover study.~     Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention~     (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or~     prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in~     left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min~     adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of~     50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery~     intervals between infusions. A crossover directly to the alternate treatment is performed~     followed by the same evaluation at Day 30±2 days .~   "
107975|NCT01642953|"~     Study preparation~        -  To progress this prospective study, the investigators analyzed the retrospective data~          of 426 patients who had been managed with conventional critical pathway after gastric~          cancer surgery during last 1 year.~        -  Through this retrospective analysis, we decided the inclusion criteria which showed~          significantly the lower complication rate and shorter hospital stay.~      Method for Prospective study~        -  Patients who enroll in this prospective study are administered and are supplied a~          liquid diet one day before surgery without bowel preparation.~        -  After gastric cancer surgery, they start sips of water on postoperative first day, and~          they are discharged once they exhibit at least three times soft diet without specific~          complaint and had normal clinical status and physical examination.~   "
108598|NCT01634789|"~     The purpose of this study is to evaluate 3 test formulations relative to a reference~     formulation.~   "
107976|NCT01642940|"~     This is a prospective, randomized, single-center, single blind, investigator initiated, two~     period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS),~     treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected~     to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet~     reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to~     either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the~     alternate therapy for an additional 15 days without an intervening washout period.~   "
107977|NCT01642927|"~     A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and~     post Left Ventricular Assist Device (LVAD) patients.~   "
107978|NCT01642914|"~     The purpose of this study is to evaluate the efficacy and safety of linaclotide compared~     with placebo in patients with chronic constipation (CC) and prominent abdominal bloating.~     This study includes an up to 3-week screening period and a 2-3 week pretreatment period.~     Patients who are eligible will be randomized to one of two doses of linaclotide or placebo~     for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement~     frequency, as well as other abdominal and bowel symptoms of CC.~   "
107979|NCT01642901|"~     Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture~     prevention and the associated morbidity of bed rest and further secondary complications.~     Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more~     effective than other agents in reducing bone mass resorption and leg fractures in~     post-menopausal women, but has not been studied in patients with acute SCI. This will be a~     randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after~     SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus~     placebo within 21 days of an SCI.~   "
107980|NCT01642888|"~     Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test~     is injected just under the skin and will, when positive, show redness and/or swelling at the~     injection site while a negative test will leave no reactions. The investigators hope that~     this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test~     e.g. may show a reaction if the person tested is BCG vaccinated.~      The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB~     disease.~      With focus on age, HIV status and CD4 count the following analyses are done (in an overall~     perspective):~        -  To compare the C-Tb test to a blood test, the QuantiFERON test.~        -  To compare the C-Tb test to the PPD test that is currently being used.~        -  To assess the safety of the C-Tb test.~   "
107981|NCT01642875|"~     Pancreatoduodenectomy carries high morbidity rates even in high-volume centers.~     Postoperative complications often preclude or delay adequate oral nutrition and nutritional~     support may be required. However, the role of perioperative nutritional supplementation in~     well-nourished patients remains controversial.~      The purpose of this study is to compare the influence of early enteral and oral nutrition on~     postoperative course and complications after pancreatoduodenectomy.~      96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral~     nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive~     standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be~     started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated~     level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and~     oral intake will be advanced as tolerated.~   "
107982|NCT01642862|"~     The inter- and intra-variability in the pharmacokinetic parameters of different formulations~     and doses of simvastatin in healthy subjects and in subjects with celiac disease in~     remission will be evaluated. Additionally, baseline values of pharmacokinetic parameters of~     simvastatin for both study groups will be determined.~   "
107983|NCT01642849|"~     This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on~     weight loss and other metabolic parameters.~      Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity~     have been well established. The detrimental effects of obesity on cardiovascular, metabolic~     and psychological parameters as well as the excess cost to the national health budget are~     astounding. One way of treatment and prevention of obesity has been the use of diet and~     exercise. In the absence of well-established superiority of one diet over another, different~     scientifically unproven diets are in common use. A palatable diet providing satiety as well~     as all essential nutrients may go a long way in treating over-weight individuals. Another~     factor has been the long-term adherence to such weight loss regimens, which in general have~     been poor. Protein diets have been known to provide greater satiety and reduced energy~     intake than carbohydrate diets, but definite long-term studies are sparse. For this study~     the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP~     diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters~     between the two diets.~   "
107984|NCT01642836|"~     Stanford Goals is a large-scale, community-based randomized controlled trial of an~     innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to~     treating overweight and obese children. Primary Research Question: Will a 3-year,~     innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM)~     community-based intervention to treat overweight and obese children significantly reduce BMI~     compared to an enhanced standard care/health and nutrition education active comparison~     intervention?~   "
107985|NCT01642823|"~     Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor~     and sometimes the entire eye. The purpose of this study is to collect the extra tissue from~     patients who undergo tumor removal for laboratory experiments that will help us understand~     not only what occurs in retinoblastoma cells but also how cells normally function. Some of~     these studies will include an evaluation of how cells control the way that genes are~     expressed, how cells know to become retinal cells, how cells remain retinal cells, how~     cells lose their identity as retinal cells, what changes make retinoblastoma cells different~     from normal retinal cells, and what changes make some retinoblastomas worse than others.~   "
108610|NCT01634633|"~     The aim of this study is to investigate the prevelence of endometrial nerve fibers in~     different gynecological pathologies~   "
107986|NCT01642810|"~     A recent study published by the Canadian Pain Society estimated the direct health care costs~     of chronic pain to be about 6 billion dollars. Over 1/3 of all Canadians reported that they~     either missed work or experienced reduced productivity due to chronic pain. Fibromyalgia~     Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom~     are still in the prime of their lives. While pain and fatigue are prominent symptoms, FMS~     sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache,~     memory and thinking problems, and depression. Standard treatments focus on medication and~     physical exercise but are not always successful. Acceptance-Based behavioural therapy (ABBT)~     is a relatively new approach that has been effective not only in treating mental health~     concerns such as anxiety and depression, but also other medical conditions such as diabetes~     and chronic pain. A novel ABBT for FMS was developed and pilot tested with a small group of~     participants. The results of this preliminary study were promising. Unfortunately, many~     people cannot adequately access available treatment due to long wait lists, prohibitive~     costs, or time/location constraints. Online treatments may offer improved access to care~     without reducing the effectiveness of treatment. Therefore, the ABBT for FMS used in the~     pilot study is being adapted to an online format and will be evaluated with a larger group~     of participants. A wait-list/control group will be employed to evaluate the effectiveness of~     the online treatment as compared with treatment-as-usual. If found effective, this treatment~     would offer patients easier access to care at a significantly reduced cost to the health~     care system.~   "
107987|NCT01642797|"~     i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted~     mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations~     compared to WLE with standard biopsy protocol.~      ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE~     with standard biopsy, can reduce the number of biopsies needed per patient for detection of~     gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.~      iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric~     IM/IN/CA.~   "
107988|NCT01642784|"~     Objective of this registry study is to compare strategy of complete vs. target lesion-only~     primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI~     (ST elevation myocardial infarction) patients.~   "
107989|NCT01642771|"~     Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-)~     may benefit more from Capecitabine chemotherapy. However, the optimum post-operative~     adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population~     with triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III~     clinical trial to verify efficacy and safety of Capecitabine in the treatment of~     triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center~     Phase III clinical study was conducted to compare efficacy and safety of sequential~     Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential~     Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as~     post-operative adjuvant chemotherapy in the treatment of triple-negative breast cancer in~     Chinese population.~   "
107990|NCT01642758|"~     Beta thalassemia intermedia syndromes are genetic anemias caused by mutations which reduce~     production of beta globin, a major component of adult hemoglobin A, the protein which~     delivers oxygen throughout the body. Patients suffer from poor growth, fatigue, heart~     failure, endocrine deficiencies, and eventually, many require chronic blood transfusions.~     There is no approved therapeutic for the deficiency of beta globin chains in beta~     thalassemia.~      This trial will study an oral therapeutic which stimulates production of fetal globin, an~     alternate type which is produced by all humans, but is normally switched off in infancy.~     This type of globin can compensate for the missing protein in beta thalassemia.~   "
107991|NCT01642745|"~     The study will compare the airway responses to two bronchoconstricting agents, mannitol and~     methacholine.~   "
107992|NCT01642732|"~     The purposes of this study are to:~        -  Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be~          taken in combination with hormonal and radiation therapy in men with high risk prostate~          cancer.~        -  Evaluate changes in patient reported quality of life~        -  Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which~          can be used to identify the progress of a disease or condition, which can help~          researchers determine the effect the study treatment has on the tumor. Biomarkers can~          also help determine areas for further research.~   "
107993|NCT01642719|"~     Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long~     sleepers (> 8 hr/night), but there has been little experimental investigation of the effects~     of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that~     older adults might be particularly vulnerable to negative effects of sleep loss, whereas~     other scientists argue that many older adults spend too much time in bed, and that moderate~     reduction of time-in-bed could help increase the quality of their sleep, and could even~     promote health and longevity, particularly in long sleepers. At 4 sites across the US, we~     will conduct a large (200 people), randomized, controlled, 5- year study to examine whether~     a 1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on~     multiple health-related outcomes, including inflammation, sleepiness, body weight, mood,~     glucose regulation, quality of life, incidence of illness, and incidence of automobile~     accidents in older long sleepers as compared to older average sleepers.~   "
107994|NCT01642706|"~     B cells are known to play an important role in auto-immune diseases by activating T cells,~     secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells~     named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis~     in mouse models. Bregs have also been identified in humans.~   "
107995|NCT01642693|"~     The purpose of the study is evaluate the histological changes of the dentinal-pulp complex~     and root resorption in maxillary premolars with intrusive orthodontic movement under a low~     power laser effects.~   "
108036|NCT01642147|"~     Few studies look into cerebral blood flow (CBF) changes during emergence from general~     anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during~     emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation~     of jugular vein bulb and transcranial Doppler.~   "
145877|NCT01145235|"~     A Registry to monitor long term safety in female subjects after treatment with Macrolane~     VRF20 and/or MacrolaneT VRF30 in the breasts.~   "
107996|NCT01642680|"~     The number of long-term cancer survivors is growing. As a result, treatment-related~     morbidity - such as cardiovascular disease, metabolic syndrome, functional decline and~     fatigue - is impacting quality of life and impairing survival. Metabolic syndrome in the~     general population is currently treated with lifestyle advice to increase physical activity~     (PA) and reduce caloric intake. This approach is still underused as standard care for cancer~     survivors. The aim of this study is investigate whether a tailored PA program that starts~     early (during curative chemotherapy with cardiovascular toxic potential) is superior in~     terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular~     morbidity to a program that starts late (after completion of chemotherapy).~   "
107997|NCT01642667|"~     The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by~     using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment~     elevation myocardial infarction (STEMI)~   "
107998|NCT01642654|"~     Objectives:~      The purpose of this research was to assess modifications caused by a concurrent water~     exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in~     the elderly and analyze the correlations between these variables after intervention.~      Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an~     intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by~     the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to~     determine the resistivity index and Cholesterol was determined using the colorimetric~     enzymatic method and test kit. Intervention with water exercise program consisted of three~     weekly sessions for 16 weeks.~   "
107999|NCT01642641|"~     The purpose of this study is to determine the most efficient treatment approach (two~     surgical and one non-surgical) in the treatment of moderate to severe chronic periodontitis,~     with regard to healing and resolution of disease, patient reported outcomes and cost~     effectiveness.~   "
108000|NCT01642628|"~     Intuitively, the investigators surmise the initial and subsequent viewing of a breast site~     following mastectomy may be traumatic. A qualitative study on the experience of viewing self~     in the mirror for a woman who has had a mastectomy has confirmed the experience is unique~     for each individual, and may well be difficult. This research study aims to determine if~     these difficult moments may be buffered by a mirror intervention providing women who are~     scheduled for a mastectomy with a hand held mirror, instructions by a Oncology Nurse~     Navigator (ONN) on how to use the mirror in initial and subsequent dressing changes, and~     offering to discuss any concerns or questions.~      The purpose of this study is to evaluate the feasibility of a nursing mirror educational~     intervention and determine if it is of potential value for women scheduled for a mastectomy.~     Results from this pilot study will help determine whether the research design, setting,~     sample, instruments, data collection and data analysis are appropriate and practical for a~     larger study.~      Hypothesis~      Women, ages 18 and over, who have had a mastectomy, and receive a planned pre-operative~     education and self-reflection intervention will have relatively improved anxiety, body~     image, depression and emotional well-being scores one to three weeks post-operatively as~     compared to those who received usual care.~   "
108001|NCT01642615|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily oral administration of dexlansoprazole delayed-release capsules in adolescents with~     erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.~   "
108002|NCT01642602|"~     The purpose of this study was to assess the safety and effectiveness of once daily oral~     administration of dexlansoprazole delayed-release capsules in adolescent participants with~     symptomatic non-erosive gastroesophageal reflux disease (GERD).~   "
108003|NCT01642589|"~     The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in~     support of registration of the vaccine in South Korea.~      Primary Objective:~        -  To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y~          and W-135, 28 days after a single dose of Menactra®.~      Secondary objectives:~        -  To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion~          rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine~        -  To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.~        -  To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers~          before and 28 days after a single dose of Menactra® or Adacel® vaccine.~   "
108004|NCT01642576|"~     This study aims to compare the effects of 8 months of diet modification, with or without~     exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation~     and quality of life in obese men.~   "
108005|NCT01642563|"~     Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency~     and severity after transfusion of standard platelets versus platelets prepared with two~     commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of~     standard versus PRT platelets. The two technologies will be analyzed separately.~      Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets~     versus incidence in recipients of control (standard) platelets.~      Secondary endpoints: time to the first grade 2 or greater bleeding event after the first~     study transfusion; proportion of transfusions given to treat breakthrough bleeding; number~     of days with grade 2 or greater bleeding during the period of platelet transfusion support;~     number of platelet units transfused and total dose of platelets transfused per day of~     thrombocytopenic platelet support; proportion of patients with acute transfusion reactions;~     post-transfusion platelet count increments~      Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization,~     frequency of clinical refractoriness to platelet transfusion with demonstrated HLA~     alloimmunization, frequency of clinical refractoriness to platelet transfusion that is~     persistent during the period of platelet support in the absence of HLA or human platelet~     antigen (HPA) alloimmunization~      Patients will be evaluated for 4 weeks after randomization.~   "
108006|NCT01642550|"~     The purpose of this study is to determine if administration of RM-131 is effective in~     improving appetite and gastrointestinal symptoms leading to the recovery of patients with~     anorexia nervosa in the outpatient setting.~   "
108007|NCT01642537|"~     The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and~     Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of~     cardiac tachyarrhythmias.~   "
108008|NCT01642524|"~     The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present~     with an injury to their head which makes them unconscios. The study compares two different~     fluids given to the patient in the out of hospital setting by a paramedic. The two fluids~     are salt water (standard treatment) versus a higher concentration of salt water mixed with a~     sugar (study fluid). The patients have an equal chance of receiving either fluid and the~     paramedic and the patient and the treating trauma surgeon do not know which fluid was~     provided in the out of hospital setting.~   "
108009|NCT01642511|"~     In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also~     the first-echelon nodal drainage site for metastasis and provides important prognostic~     information in breast cancer patients. The internal mammary sentinel lymph node biopsy~     (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection.~     But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical~     trial is carried out to improve the visualization rate of IMSLN with modified techniques:~     (1) The radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The~     radiotracer is injected in a high volume. (3) The radiotracer should be injected under~     ultrasonographic guidance.~   "
108010|NCT01642498|"~     The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in~     patients with treatment-resistant hypertension.~   "
108011|NCT01642485|"~     Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough~     electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval,~     which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug.~     However, there is no published data clarifying this issue. There is also a paucity of data~     investigating ethnic differences of the effects of medicines on QTc.~      The aims of the study were to compare the effect of different food contents to placebo on~     the changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the~     ECG. This was done by giving different treatments on separate days, which included~     intravenous insulin, a high carbohydrate breakfast [>70%], and a calorie reduced low~     carbohydrate American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive~     control and was given with and without food to Caucasian and Japanese volunteers to~     investigate racial differences.~   "
108012|NCT01642472|"~     This is a phase III, multicentre, long-term open-label extension of the phase III study:~     Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III~     extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month~     open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl~     extension 2 (PGL11-024).~      This proposed study consists of 4 further consecutive courses of 3 months (84 days) open~     label ulipristal acetate 10mg once daily treatment each separated by a drug free period.~   "
108013|NCT01642459|"~     The investigators hypothesis that aneurysms and stenoses will be decreased if the direction~     of inserted arterial needle were same as the direction of blood flow, when compared to the~     opposite direction puncture.~   "
108014|NCT01642446|"~     There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with~     cirrhotic portal hypertension, While this group of patients are classified as hepatectomy~     contraindication according to guidelines from National Comprehensive Cancer Network (NCCN)~     and American Association for the Study of Liver Diseases (AASLD). With improvement of~     surgical technique, preoperative evaluation, and perioperative management,especially the~     Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical~     intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal~     hypertension.However, most of the previous studies were either retrospective or with small~     samples.~      The investigators project is a prospective randomized controlled trial, planning to compare~     the safety, efficacy and quality of life between precise hepatectomy and combined~     interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal~     hypertension, to make a further understanding of optimal strategy.~   "
108015|NCT01642433|"~     The most likely outcome of smoking cessation attempts is relapse, underscoring the need to~     advance novel treatments. Preclinical research shows that the noradrenergic system is~     critical for modulating drug-seeking behavior and recent findings indicate that the~     α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement.~     Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An~     efficient method for screening novel smoking cessation medications is to integrate human~     laboratory paradigms in the context of brief, randomized trials of smoking cessation that~     include smokers motivated to quit. This study aims to provide an initial test of prazosin~     for smoking cessation by implementing a brief, randomized trial that will include both human~     laboratory and clinical phenotypes. This approach will allow an efficient but sensitive~     method for medication screening that maximizes clinical validity.~   "
108016|NCT01642420|"~     Alzheimers disease (AD) is the most common course of cognitive decline and thereby the~     course of more than half of all cases of dementia. A proper AD diagnosis is rested on a~     number of examinations and tests, which combined can make AD diagnosis likely. But no single~     test or examination can unambiguous determine whether the patient has AD or not.~     Comparatively no examination or test can with accuracy predict whether a healthy person or a~     person with only mild cognitive (MCI)impairment in time will evolve AD.~      Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT~     analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely~     available diagnostic methods, which have the potential to diagnose AD at an early stage in a~     reliable accurate way. But they also have the potential to predict which patients diagnosed~     with MCI have particular risk of developing dementia.~      The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT~     analyses and TUG-DT outcome and clinical features in healthy persons as well as patients~     with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which~     patients with MCI will in time evolve AD.~   "
108037|NCT01642134|"~     The purpose of this study is to determine the incidence of major vascular events (ischemic~     or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral~     anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.~   "
108038|NCT01642121|"~     This laboratory study is looking into biomarkers in samples from younger patients with acute~     myeloid leukemia. Studying samples of bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer~   "
108017|NCT01642407|"~     Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease.~     In many patients, the course of PAH is a steady deterioration and reduced life expectancy.~      Sildenafil was approved by the European Commission for the treatment of PAH in pediatric~     patients in May 2011, making it the first agent to be approved for the treatment of children~     with PAH. The approval was based on the largest placebo-controlled study to be conducted in~     this population. The recommended dose in pediatric patients aged 1 year to 17 years old is~     10 mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not~     recommended in pediatrics patients.~      This study is an open-label, multi-center study to investigate safety, efficacy and~     pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.~   "
108018|NCT01642394|"~     Main objective:To evaluate the effectiveness of the Diabetes Self-Management Programme~     (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and~     self-efficacy in adult patients with type 2 diabetes, compared with current standard care of~     patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.~      Secondary objectives:~        -  To evaluate the impact of the implementation of DSMP in the use of health services.~        -  To assess the impact of DSMP in the cost of treatment of the involved population.~        -  To evaluate the improvement in physical activity and diet patterns among the~          participants.~        -  To describe the feasibility of implementing the DSMP in the Basque Country's primary~          health care system Methodology: Randomized clinical trial in which patients diagnosed~          with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of~          the Basque country, who agree to participate in the study, will be randomly assigned to~          two groups: the intervention group (the DSMP programme) and the control group. The~          intervention will be performed by trained patients with type 2 diabetes and health~          professionals and it will consist in 6 group sessions of two and a half hours each, on~          a weekly basis with a overall duration of 6 weeks. The session content includes~          techniques for dealing with problems, promotion of exercise, nutrition concepts, proper~          use of medication, effective communication and basic knowledge about diabetes and its~          complications. The sessions are supported with educational material. The main outcome~          is the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are~          reduction of cardiovascular risk, increase of quality of life and self-efficacy. The~          results will be analyzed at 6, 12 and 24 months after the intervention.~      Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on~     the program DSMP conducted by previously trained lay persons and health professionals,~     improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to~     regular health education. On the other hand, it is expected to see improvements in the~     quality of life for these patients. The intervention may reduce the weight and~     cardiovascular risk due to changes in the physical activity and diet patterns, getting to a~     more appropriate use of health services and medication. It is expected that changes in the~     variables occur 6 months after the intervention and remain over the time~   "
108019|NCT01642381|"~     The purpose of this study is to investigate the critical components of motivational~     interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic~     drinking. The study will disaggregate MI into its component parts and test full MI compared~     to MI without its directive strategies. This study will test whether the directive elements~     of MI are critical or whether MI effects may be attributable solely to its Rogerian,~     non-directive components. For more information, go to http://caspirnyc.org/p_motion.html~   "
108020|NCT01642368|"~     The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food~     ingredients in diets can significantly change omega-3 blood profiles with 10 weeks of a~     7-day menu in men and women (18-40 years old). We want to look at the effect on a person's~     response to cognition, satiety and physical fitness. Investigators think that low omega-6~     and moderate omega-3 fatty acid diets may regulate emotional response and help to return to~     normal after load carrying activities. We plan to test the effects of improving overall~     fatty acids on emotional response, satiety, and physical fitness levels by a diet with an~     improved omega-3 to omega-6 diet compared to a control diet.~   "
108021|NCT01642355|"~     The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults~     to Achieve Cardiovascular Targets) is to determine the best management strategy for patients~     undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will~     enroll 400 patients post-cardiovascular intervention. The study will compare different~     cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult,~     and (3) cardiovascular prevention consult with a behavioral intervention program over a~     6-month period. The trial hypothesis is that for patients undergoing a cardiovascular~     intervention, a prevention consult and behavioral intervention is superior to usual care in~     reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary~     endpoints include other lipid values, metabolic risk, smoking cessation, physical activity,~     nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin~     enrollment in the June of 2012.~   "
108022|NCT01642342|"~     This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion~     protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to~     people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that~     promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk~     colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice~   "
108023|NCT01642329|"~     The purpose of this Registry is creating a database management that allows continuous~     monitoring characteristics, evolution, prognostic indicators and management of patients with~     ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice~     recommendations for diagnosis and treatment of ACS and monitor its evolution.~   "
108024|NCT01642316|"~     Testing and teaching are completely interrelated in education process; using various kinds~     of tests teachers are able to anticipate about the strong and weak points of learning in~     students, their progress and their accomplishment. The influence a test on teaching and~     learning is commonly referred to as washback. Testing washback is a twisted concept that~     becomes even more complex under a various interpretations of the washback phenomenon on~     teaching and learning. This study aimed to describe washback behaviors of students, in the~     low stakes testing in an ESP environment in two-fold. First, the study investigated the~     effects of different formative tests on Iranian medical students' English reading~     comprehension achievement. Secondly, the study explores the effects of washback on the~     students' attitudes toward English reading comprehension. The pre- and post-tests and one~     questionnaire were used to collect the data from Iranian medical students. Data were~     analyzed by paired t-test, t-test, and Mann-Whitney U test.~   "
108077|NCT01641614|"~     The purpose of this study is to evaluate the immediately clinic and ultramicroscopic~     myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested~     heart versus on-pump empty beating heart surgical techniques.~   "
108078|NCT01641601|"~     This is a randomized study evaluating the impact of pre-hospital cervical ripening with a~     transcervical Foley balloon before labor induction in full-term pregnancies on the length of~     inpatient labor induction and maternal satisfaction with the labor induction process. The~     investigators hypothesize that women who receive pre-hospital cervical ripening will have a~     shorter duration of inpatient labor induction as compared to women without pre-hospital~     cervical ripening.~   "
108025|NCT01642303|"~     Improvement of the internet and its tremendous growth has caused significant progress in~     transformation of information. Nowadays in any place of the world and in any time of the day~     by accessing through internet every student can use different kinds of information in World~     Wide Web which let him to make the best decision what, how and when to study. One of these~     educational technologies which are beneficial to learners is vodcast or video recording~     which are accessible through the internet.This paper is going to examine the listening~     comprehension in EFL learners and whether it may be improved by using vodcasts. So106~     language learners of four different classes of Iranian higher intermediate in an English~     institute were chosen for this study. These learners were pre-tested by IELTS Listening~     Comprehension. Two classes were chosen as subject group which consisted of 54 learners. The~     remaining two classes were chosen as control group which consisted of 52 learners. Both~     groups were taught Listening Impact book, but students in subject group were provided some~     vodcasts based on the topic of their lessons. After 12 weeks of teaching both groups were~     post-tested.listening comprehension will be compared using independent t-test and paired~     t-test.~   "
108026|NCT01642277|"~     No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection~     (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as~     evidenced by routine microbiology cultures. Recent work by the group on the genitourinary~     microbiome (GUM) has shown that female urine, even in the absence of culture evidence of~     bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine~     and sequenced to identify bacterial species present in urine. From this the investigators~     can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a~     difference in the bacterial communities in the urine of women who respond to Solifenacin, a~     drug used to treat OAB, versus those that do not.~   "
108027|NCT01642264|"~     The primary aim of this study was to develop an interactive Internet-based program~     (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric~     respiratory therapists and nurses to provide brief, hospital-based tobacco cessation~     interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I~     prototype which was evaluated with 50 pediatric respiratory therapists and nurses.~      In Phase II, the investigators redesigned and expanded the program with input from 50~     educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical~     Center. Then the investigators evaluated the Phase II program in a randomized trial in which~     215 respiratory therapists and nurses from two large, urban children's hospitals were~     randomly assigned within hospital to either the Intervention (Training) Condition, or to a~     Delayed Treatment (Training) Control condition.~      Participants' demographic and tobacco use history were measured at baseline, and tobacco~     cessation intervention behaviors, attitudes, knowledge, perceived barriers, and~     self-efficacy regarding delivery of a tobacco cessation intervention were measured at~     baseline, 1 week post-training, and at 3 months post-training. User satisfaction measures~     were also collected at 1 week post-training from Intervention Condition participants. The~     investigators hypothesized that participants in the Intervention Condition would have~     increased tobacco cessation behaviors, positive attitudes and self-efficacy, and decreased~     perceived barriers than participants i the Delayed-Treatment Control Condition.~      Following evaluation, the investigators developed a final version of the interactive~     training program and created the administrative infrastructure for a marketable product.~   "
108028|NCT01642251|"~     This randomized phase I/II trial studies the side effects and best dose of veliparib when~     given together with or without cisplatin and etoposide and to see how well they work in~     treating patients with extensive stage small cell lung cancer or large cell neuroendocrine~     non-small cell lung cancer that has spread to other parts of the body. Drugs used in~     chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may~     work better in treating patients with extensive stage small cell lung cancer or metastatic~     large cell neuroendocrine non-small cell lung cancer.~   "
108029|NCT01642238|"~     The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin~     and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and~     bivalirudin).~   "
108030|NCT01642225|"~     Purpose of the study:~      The specific aims of this study are to evaluate overall efficacy and safety of the~     pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors~     affecting treatment outcomes in order to improve patient selection and treatment protocols~     for future patients.~   "
108031|NCT01642212|"~     This is a clinical trial to test an experimental drug for the treatment of Eosinophilic~     Esophagitis (EoE)~   "
108032|NCT01642199|"~     The primary aim of this study is to determine whether reduced intensity behavioral weight~     loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than~     rBWL + Mentor Health Coaches and rBWL alone.~   "
108033|NCT01642186|"~     There is no effective standard treatment for fibrolamellar liver cancer that cannot be~     removed by surgery. The investigators want to find out what effects, good and/or bad, 3~     drugs called letrozole, leuprolide and everolimus will have on cancer. All of these drugs~     are FDA approved for the treatment of different cancers. Letrozole and leuprolide stop the~     body from producing estrogen, a normal hormone produced by the body. Too much estrogen may~     help fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in~     the body that can help cancer grow. The combination of letrozole and leuprolide plus~     everolimus may work well together.~   "
108034|NCT01642173|"~     The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an~     integral role in early atherosclerosis, and contributes to the mechanism of coronary~     endothelial dysfunction and to the structural and mechanical properties that characterize~     plaque vulnerability. Thus, the investigators study will characterize prospectively the~     correlation between the functional and structural vascular wall properties, and the activity~     of the Lp-PLA2 pathway.~   "
108035|NCT01642160|"~     Does an internet based text or email interaction and education improve CPAP compliance for~     patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.~   "
147587|NCT01122563|"~     This study is to evaluate change of overactive bladder symptom scores (OABSS) between,~     before and after solifenacin treatment to OAB subjects.~   "
108039|NCT01642108|"~     Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and~     insulin resistance. Studies have shown that most of the populations in which insulin~     resistance is considered to be the primary pathogenetic cause of diabetes, have a higher~     degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin~     secretion plays a predominant role in the non-obese subtype of T2DM which includes majority~     of Japanese patients.~      Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of~     T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1)~     and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients~     with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial~     glucose concentrations through increases in glucose dependent insulin release and~     suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using~     standardized meal showed that sitagliptin improved glucose control with decreased glucagon~     levels and increased insulin concentration in obese or overweight T2DM patients with BMI >~     25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in~     non-obese patients with low insulin secretion are not known. Therefore, the investigators~     will examine the effect of sitagliptin on glycemic control and the mechanism involved using~     a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are < 25~     kg/m2.~   "
108040|NCT01642095|"~     This laboratory study is looking into biomarkers in samples from younger patients with~     kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~   "
108041|NCT01642082|"~     This phase II trial studies how well dalantercept works in treating patients with recurrent~     or persistent endometrial cancer. Dalantercept may stop the growth of endometrial cancer by~     blocking blood flow to the tumor.~   "
108042|NCT01642069|"~     This laboratory study is looking into genes in samples from younger patients with acute~     megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in RNA and identify biomarkers related to cancer~   "
108043|NCT01642056|"~     Background:~        -  Mitochondria are the parts of cells that help produce energy. Metabolism is the process~          by which the body uses energy to help cells grow and reproduce. Metabolic and~          mitochondrial disorders affect the body s ability to produce and store energy. These~          disorders can cause a wide variety of problems, but most often they affect the muscles~          and the brain, where energy requirements are high. Treatment is difficult because the~          exact source of the problem is hard to detect.~        -  EPI-743 is a new drug that is based on vitamin E. Tests have shown that it can help~          improve the function of cells with mitochondrial problems. It may be able to treat~          people with genetic disorders that affect metabolism and mitochondria.~      Objectives:~      - To see if EPI-743 can improve energy production and use in people with mitochondrial or~     metabolic disorders.~      Eligibility:~      - Children between 2 and 11 years of age who have metabolic or mitochondrial problems.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  The study will last about 13 months. Participants will have seven 3- to 5-day inpatient~          study visits about 3 months apart.~        -  Participants will take either EPI-743 or a placebo for the first 6 months of the study.~          After 6 months, there will be a 1-month rest period. Then, those who received EPI-743~          in the first 6 months will take the placebo for the next 6 months. Those who had the~          placebo will take EPI-743.~        -  During each inpatient study visit, participants will have a physical exam. A 24-hour~          urine collection will be obtained. Blood samples will also be taken. Imaging studies~          and other tests may be performed as directed by the study researchers.~   "
108044|NCT01642043|"~     Greater trochanteric pain syndrome (GTPS) is a common cause of musculoskeletal pain.~      The primary aim of this study is to describe the soft tissue and bony structural ultrasound~     (US) findings identified in the lateral hip and iliotibial band (ITB) in patients presenting~     with greater trochanteric pain syndrome (GTPS) in an outpatient rheumatology clinic.~   "
108045|NCT01642030|"~     Pain is very common in persons with a history of addiction, but few studies have examined~     the best treatment of pain in this population. This is a study to determine the pain relief~     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons~     maintained on stable doses of methadone or buprenorphine. Experimental sessions will require~     overnight stays on a residential research unit. In these sessions, persons will be exposed~     to standard experimental pain techniques at baseline and then rate the relief (if any)~     provided by the study medication when exposed to the same techniques. Persons will be asked~     to participate in 2 or 3 sessions, each separated by at least 7 days.~   "
108046|NCT01642017|"~     This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial~     to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly~     patients, selected according to the International Society of Geriatric Oncology~     (SIOG)classification (Group 2).~      It is expected that a total number of 30 patients maximum will be enrolled in the study on~     30 months : 18 months accrual - 12 months follow up.~      Eligible patients will be enrolled into a standard 3+3 design with a starting dose of~     Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels~     will be explored.~      Toxicity of the schedule will be assessed during the first cycle. Patients will receive~     study medication until disease progression. After treatment discontinuation, patients will~     be followed during one year.~   "
108047|NCT01642004|"~     The purpose of the study is to compare the overall survival of BMS-936558 as compared with~     Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure~     of prior platinum-based chemotherapy.~   "
108048|NCT01641991|"~     A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of~     BioThrax® in varying dose regimens with the primary objective of obtaining information on~     possible dose-sparing strategies in the event of a major biothreat.~   "
108049|NCT01641978|"~     The assessment of the level of consciousness in patients admitted to intensive care units~     (ICU) can be complicated because the variables that are evaluated can be interpreted in a~     different way by different observers.~      The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS)~     among ICU nurses and assess whether professional experience change the results. Secondary~     objective: to determine interobserver agreement in each of the three components (motor~     response, verbal and eye opening) of the GCS~   "
108079|NCT01641588|"~     The aim of this trial has been to explore the effects of self-positioning on cognitive~     performance in the work environment using a standardized cognitive test battery to evaluate~     executive function under two conditions: sitting and standing.~   "
109433|NCT01623856|"~     This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying~     samples of blood and tissue from patients with cancer in the laboratory may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to cancer~   "
108050|NCT01641965|"~     Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral~     sclerosis patients remains unclear. The hypothesis of the study is that the early use of~     NIV, in the initial phase of respiratory muscle weakness, improves the prognosis of ALS~     patients.~      Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.~      Secondary objectives:To determine the effects from early NIV in the progression of~     respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of~     ALS patients. To evaluate the correlation between the FVC and other parameters of~     respiratory evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure~     (SNP), nocturnal desaturation) and their utility in the early indication of the NIV. To~     evaluate the tolerance to the early NIV.~      Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel~     treatment design. Patients will be included when their FVC reaches the threshold of the 75%~     of the predicted value and will be randomized in: Group A: the NIV treatment will begin~     immediately and Group B: the NIV treatment will be started when patients fulfil at least one~     of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45~     mmHg. Follow-up visits will be done every three months with pulmonary function test,~     nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease~     progression (ALSFSR-R scale), tolerance and compliance with NIV.~   "
108051|NCT01641952|"~     This observational, prospective, multicenter study will evaluate the efficacy and safety of~     MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response~     or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according~     to the current standard and in line with the summary of product characteristics at a dose of~     1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.~   "
108052|NCT01641939|"~     This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and~     safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or~     paclitaxel) treatment in participants with human epidermal growth factor receptor 2~     (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants~     will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab~     emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks;~     Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy~     (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2~     kg IV every week per investigator choice). At the end of the first stage of the study, the~     dose and schedule of trastuzumab emtansine that will be used in the second stage of the~     study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen~     selection analysis will be made after approximately 100 participants across all three study~     arms have been treated for at least 12 weeks.~      Once a trastuzumab emtansine regimen has been selected, Stage I participants who were~     assigned to the treatment arm which was selected for Stage II of the study and participants~     who were in the standard taxane group will continue to receive their assigned treatment~     regimen. Stage I participants who were assigned to the regimen that was not selected for~     further evaluation will continue to receive their assigned regimen and will continue to be~     followed for efficacy and safety. In Stage II of the study, additional participants will be~     recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab~     emtansine or to the standard taxane therapy. Participants will receive study treatment until~     disease progression, unacceptable toxicity, initiation of another cancer therapy or~     withdrawal.~   "
108053|NCT01641926|"~     This study is being done to compare the safety and efficacy of PEG-Intron™ to that of~     PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg]~     positive or negative) who have not previously been treated with interferon.~   "
108054|NCT01641913|"~     Do patient's with eosinophilic esophagitis have increased small intestinal permeability and~     if this changes in response to topically administered esophageal steroids?~   "
108055|NCT01641900|"~     The investigators will test the hypothesis that the sleep medication, eszopiclone, can~     normalize brain activity during sleep and improve memory in patients with schizophrenia. The~     investigators will do this by comparing sleep and performance in participants taking~     eszopiclone to participants taking placebo. The investigators will study healthy subjects~     and patients with schizophrenia taking atypical antipsychotic medications.~   "
108056|NCT01641887|"~     The study is to test a decision aid that is designed to help patients make decision~     regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid~     is constructed we will test and assess the aid on ~100 patients who have GERD to assess~     effectiveness.~   "
108057|NCT01641874|"~     The purpose of the study is to explore if a subgroup of people with osteoarthritic knees can~     be identified using the McKenzie System of Mechanical Diagnosis and Therapy.~      In the spine this subgroup, termed derangement,has been shown to respond rapidly to specific~     directional exercises.~      The trial will explore whether these derangements in the knee respond to specific exercises~     compared to a control group with no exercises and non-derangement knees given general~     exercises.~   "
108058|NCT01641861|"~     The purpose study are to evaluate the efficacy of Papacarie® for caries removal in~     comparison to the conventional drilling method.~   "
108059|NCT01641848|"~     The primary objective of this study is to collect preoperative, operative and postoperative~     clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total~     Ankle Prosthesis.~   "
108060|NCT01641835|"~     Collect OCT data to evaluate the range and age trend of ocular measurements.~   "
108061|NCT01641822|"~     The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen~     with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in~     adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa~     (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be~     eligible for randomization in the comparative phase if they have not received non-study oral~     antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between~     Visits 2 and 3, have not developed a condition requiring hospitalization or other change in~     clinical status which, in the opinion of the investigator would preclude their ability to~     continue in the study, and have demonstrated at least 50% TIS compliance. Participants~     enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each~     cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28~     days.~   "
108080|NCT01641575|"~     The purpose of the first part of the study is to evaluate the safety, tolerability, and~     pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin~     given to patients with advanced solid tumors, and to select a dose for further evaluation in~     the second part of the study.~      The purpose of the second part of the study is to determine the safety, tolerability, and~     exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to~     patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).~   "
108062|NCT01641809|"~     The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral~     activity and tolerability in HIV-1 infected, antiretroviral naive subjects.~      This study consists of two parts:~      Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4~     treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of~     GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of~     open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse~     transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either~     abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the~     Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete~     24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1~     ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of~     virologic rebound) will become eligible for the Maintenance Phase of this study.~      Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue~     their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily~     for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug~     ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects~     randomized to the EFV arm will continue on their randomized regimen through Week 96.~      After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to~     continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and~     until it is locally approved and commercially available.~   "
108063|NCT01641796|"~     This is an expanded access treatment protocol designed to provide a topical cream treatment~     option to military health care beneficiaries with parasitologically confirmed uncomplicated~     Cutaneous Leishmaniasis.~   "
108064|NCT01641783|"~     Gastric cancer remains one of the major causes of cancer deaths around the world,especially~     in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is~     still poor, so the investigators urgently need an effective strategy to treat advanced~     gastric cancer, however, there was no recommended First-line chemotherapy for advanced~     gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab)~     Paclitaxel (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in~     breast cancer as first-line chemotherapy in many countries. The investigator then initiated~     a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the~     first-line treatment in advanced gastric cancer to observe the efficacy and safety.~   "
108065|NCT01641770|"~     The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS)~     plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe~     malnutrition.~   "
108066|NCT01641757|"~     Periodontitis is a destructive chronic infection of the gums, ligaments, and bone,~     predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at~     increased risk of systemic diseases. Increased prevalence of periodontal disease has been~     reported in patients with chronic kidney disease, especially in dialysis patients. Chronic~     kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys~     loose their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by~     serum albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney~     diseases. Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic~     renal failure. A proposed mechanism for the effect of periodontitis on the development of~     kidney disease is systemic inflammation. The deleterious effects of systemic inflammation on~     kidney function could occur during the period of active periodontal infection and accumulate~     during the life time of the individual. This randomized control trial is designed to observe~     the effect of non-surgical periodontal therapy on serum albumin levels of patients on~     maintenance hemodialysis therapy. Patients will undergo periodontal examination and their~     serum albumin levels will be checked. Then they will be randomly divided in two groups. One~     group will be given non surgical periodontal treatment and second group will be offered late~     treatment. After 6 weeks 1st group will be reevaluated by serum albumin level and~     periodontal examination to observe the effect of non-surgical periodontal therapy.~     Statistical analyses shall be performed using SPSS software. T tests and Chi-sq tests shall~     be used to test differences according to periodontal status for continuous and categorical~     variables, respectively. The level of significance is set at p<0.05.~   "
108067|NCT01641744|"~     The study examines the effectiveness of parent-child Group Attachment Based Intervention~     (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting~     skills classes. GABI directly addresses the needs of isolated, marginalized families, with~     the goals of of enhancing parent coping and resilience, and improving parent-child~     attachment relationships.~      We hypothesize that compared to usual care, GABI will be associated with improved child,~     parent and parent-child outcomes.~   "
108068|NCT01641731|"~     Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free.~     The analysis of factors that may influence the outcome is of utmost importance.~      The aim of the study is to analyse the efficacy and safety of the induction phase of oral~     tolerance induction according to specific IgE level, as well as adverse events during the~     maintenance phase.~      Patients allergic to cow's milk are to be included in an oral tolerance induction protocol.~     Patients will be grouped according to specific IgE levels in serum (ImmunoCAP) into group I~     (sIgE<3.5 kU/L), II (sIgE 3.5-17 kU/L) and III (>17-50kU/L). Allergic children with similar~     characteristics will included as a control group. Visits are established at 1, 6 and 12~     months after the induction phase. Serum specific IgE levels to cow's milk and its proteins~     will be determined at inclusion, and at 6 and 12 months visits after the induction phase.~   "
108069|NCT01641718|"~     Inguinal hernia repairs belong to the most common surgical procedures worldwide.~     Increasingly they are performed using endoscopical techniques (laparoscopy). Many surgeons~     prefer to cover the hernia gap with a mesh to prevent recurrence. For it, the mesh must be~     fixed tightly, but tension free. During laparoscopic surgery the mesh is fixed commonly with~     staples or tissue glue. However, it is not uncommon that staples cause pain at the staple~     sites while moving. In addition, staples can cause scarring of the abdominal wall leading to~     chronic pain.~      Aim of the study is to provide evidence that mesh fixation with tissue glue causes less~     postoperative pain compared to fixation with staples.~      Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation~     with tissue glue or staples (ratio 1:1).~      Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one~     side and staple fixation on the other side. The side treated with tissue glue will be~     randomized (ratio 1:1).~   "
108175|NCT01640314|"~     The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection~     of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly~     subjects and the antibody response to each influenza vaccine antigen, as measured by~     hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and~     elderly subjects in compliance with the requirements of the current EU recommendations for~     clinical trials related to yearly licensing of influenza vaccines.~   "
108070|NCT01641705|"~     Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by~     peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is~     estimated that the RA reaches about 0.5% of the population. According to data from DATASUS,~     was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in~     2005-2007.~      The main bodily changes are related to joint problems, however, systemic manifestations are~     also found in organs such as lung and heart. Although cardiovascular diseases are the most~     responsible of the deaths AR, pulmonary complications are common and account for 10% to 15%~     of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes~     significant morbidity and mortality in these patients. Although pulmonary involvement is a~     frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not~     yet been precisely established. Several lung disorders such as interstitial pulmonary~     fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that~     studies of lung function appear to be a valuable helper for radiography in the evaluation of~     pulmonary involvement in connective tissue diseases. Previous studies indicate that patients~     with RA have an increased incidence of abnormal lung function, according to assessments~     including spirometry, lung volume tests and diffusion capacity of carbon monoxide.~      Thus, the main objective of this study is to analyze the respiratory mechanics of patients~     with RA. Specific objectives were to seek to understand whether a relationship exists~     between duration of rheumatoid disease and lung function in these patients.~      For this, the investigators used 18 subjects in the control group, free of pulmonary disease~     and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4~     groups of 18 volunteers each, classified according to disease duration (0-5 years, 6-10~     years, 11-15 years and> or = 16 years). It is noteworthy that all patients in the RA group~     will also be non-smokers, since it is already known in the literature that smoking impairs~     lung function. All individuals will perform the function test with a trained technician and~     qualified to function. The examinations will be conducted: Forced oscillation technique and~     spirometry, in that order.~   "
108071|NCT01641692|"~     This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block~     design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with~     placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are~     currently using non-ICS controller medications. Subjects will participate in the study for~     up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure~     adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will~     be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment~     sequence.~      A sub-group of subjects at selected sites (approximately 30% of the total population) will~     have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic~     sampling at the start and end of each treatment period. Safety assessments will include~     monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily~     PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic~     analysis.~   "
108072|NCT01641679|"~     After initial treatment of differentiated thyroid cancer patients (DTC) are followed by a~     blood test, a biomarker called thyroglobulin, in order to detect a possible recurrence.~     Nowadays patients are treated 'blindly' with high dose radioactive iodine to treat a~     suspected recurrence. However, the scan made after therapy to verify the effect of the~     treatment shows that in up to 50% the treatment could be considered as futile.~      124I - a radioactive isotope - in combination with whole body PET became recently available~     for use in the follow-up of DTC. This could make it possible before the therapy with high~     dose radioactive iodine to determine the extensiveness of the disease and whether effect of~     the therapy could be expected. Additionally, recurrent DTC lesions that do not accumulate~     iodine can be found without the futile treatment with 131I. FDG-PET (another PET modality)~     is able to detect these lesions. The value of FDG-PET before 131I treatment however has not~     been tested.~      The combination of these two diagnostic tools, 124I-PET and FDG-PET, has a potential to~     allow earlier and better restaging and selection for treatment~   "
108073|NCT01641666|"~     This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg~     three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5~     mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400~     mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic~     Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and~     ribavirin in Vietnam.~   "
108074|NCT01641653|"~     This research is being done to investigate if patients who receive a commonly used sedative~     drug, known as midazolam, are likely to have high blood sugar levels during the stressful~     period during and immediately after surgery. A sedative drug is used to relax a person~     without making them sleepy. This drug is also helpful in reducing the memory of the~     stressful experience before the anesthesiologists administers anesthesia. Everyone has~     glucose or sugar in their blood stream. This sugar gives energy to our organs to allow them~     to work. Since high blood sugar levels may be associated with complications like wound~     infections, the investigators research is being done to find if patients who receive a~     sedative medication prior to their surgical procedure have lower blood sugars during the~     surgery then a patient who does not receive the sedation. The investigators would like to~     know if the administration of this commonly used drug will help patients maintain a normal~     glucose level during a stressful period.~   "
108075|NCT01641640|"~     This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and~     pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in~     patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of~     sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).~   "
108076|NCT01641627|"~     Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy~     and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor~     tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy.~     It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration~     of hospitalisation.~      Data underline the importance of afferent input integrity in the maintenance of muscle~     characteristics and postural control, and suggest that countermeasure programs based on the~     stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls.~     In particular, fundamental studies performed in rodents by the investigators laboratory have~     demonstrated that the adverse structural and functional adaptations which occur during~     muscle deconditioning can be counteracted through adequate physiological stimuli such as~     activation of proprioceptors. Based on this scientific expertise, the investigators aim is~     thus to prevent muscle atrophy and its functional consequences on posture and locomotion,~     following a surgical intervention in humans .~      The investigators will develop a device allowing stimulation of foot and ankle~     proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be~     tested on a selected population confined to bed during a post-operative period (knee~     replacement). It efficiency will be evaluated by means of three parameters: muscle force of~     ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and~     balance analysis).~      The technique developed in the present project could bring benefits to patients confined to~     bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate~     to health and quality of life of these patients. In addition, this device might allow to~     consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.~   "
108218|NCT01639729|"~     Determine whether the amount of drug absorbed is different if the tablet is placed under the~     tongue, placed between the cheek and gum, or swallowed.~   "
108081|NCT01641562|"~     Breast cancer represents the most frequent form of neoplasia in women worldwide, being~     responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and~     research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are~     extremely powerful antineoplastic drugs, which alone or in association to anthracyclines,~     increase survival and lower the recurrence rate of cancer, but their use is limited by~     cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from~     subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac~     dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters.~     However, these cannot detect subtle, early changes of cardiac structure and function.~     Consequently, description of new parameters, which could detect cardiac dysfunction in an~     early stage, becomes essential for detecting the group of patients at risk for irreversible~     heart failure. The objectives of the investigators project, in patients with breast cancer~     treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction,~     to describe new parameters for the early diagnosis of cardiotoxicity, and to define~     predictive models for cardiotoxicity. Meanwhile, project will publish the results in~     prestigious journals, leading to an increase of the visibility of Romanian research~     internationally.~   "
108082|NCT01641549|"~     Malfunction of mechanical heart valves due to clot formation is a potentially devastating~     complication. It often results in heart failure, death or stroke. This condition occurs~     frequently in patients with mechanical valves in developing countries because they are~     unable to monitor and adjust the dose of blood thinning medications. The best treatment~     modality for the treatment of patients with this condition is not known. There is no~     reliable data from clinical trials to guide treatment and there are no firm guidelines.~     Treatment with clot-busting drugs is most commonly used because these drugs (e.g.,~     streptokinase) are readily available, cheap, and easy to use. However, this treatment is~     associated with high rates of treatment-related side-effects (death, life-threatening~     bleeding and stroke). Moreover, some recent studies suggest that clot-busting drugs may not~     be as efficacious in restoring valve function, as previously believed. Emergency surgery is~     less often used because it is more expensive and the required facilities and manpower are~     not available at all times at all places. But there is evidence to suggest that surgery~     results in better success rates with a lower risk of bleeding and stroke. Well-designed~     prospective randomised trials (the gold-standard for reliable evidence) comparing the~     efficacy, safety and cost-effectiveness of the two modalities, are needed to help doctors in~     developing countries make informed decisions when treating patients with clotted mechanical~     heart valves. The investigators propose to perform a randomised controlled trial comparing~     emergency surgery with treatment with clot-busting agents in patients with clotted~     mechanical valves. The study will be conducted over 4 years at a single, university hospital~     in a developing country. This study will determine how often patients who are treated with~     surgery will be discharged from hospital, with completely restored valve function, without~     having suffered a stroke or life-threatening bleeding, when compared to those who received~     clot-busting drugs. The investigators will also find out which of the treatments is safe and~     cost-effective.~   "
108083|NCT01641536|"~     This study is an open label, dose escalation study using the classical 3+3 design to~     determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA~     therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic~     hepatitis B patients.~   "
108084|NCT01641523|"~     Multicenter, prospective, comparative, observational study with regular follow-up visits.~      The project's aim is long-term follow-up of patients affected by large and complex~     craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial~     (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous~     bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and~     safety among the three treatments.~      Elegibility to each treatment will respect the standard clinical practice. Each investigator~     will respect his own hospital criteria for cranial reconstruction.~      Each centre's agreement to participate the study is totally voluntary.~      The study sample size has not been defined on statistical criteria: the study population was~     set at 100 consecutive patients treated with cranioplasty reconstruction with one of the~     three foreseen group.~      Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment~     imbalance between centres involved.~      Primary study end-points are: evaluation of adverse event incidence after surgical~     treatment.~      Secondary end-points are: quality of life improvement, evaluation of bone continuity~     restoration evaluated by CT scan analysis, neurological improvement.~   "
108085|NCT01641510|"~     The investigators hypothesize that reduced loading dose of prasugrel followed by reduced~     maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism~     undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24~     hours and 30 days later which is associated with major adverse cardiovascular events.~   "
108086|NCT01641497|"~     Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years~     with a endometrial cancer.~   "
108087|NCT01641484|"~     Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate~     is inexplicably close to 30%. However, important volume of those tumors and their hypoxia~     degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.~      Persistence of tumor hypoxia could be a predictive factor of local control~   "
108088|NCT01641471|"~     A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain~     Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing~     pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA).~     This will be a placebo-controlled study involving 116 patients undergoing primary unilateral~     TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an~     active TENS unit and the other 58 patients will be randomly selected to be treated with the~     placebo TENS unit (control group). Patients will be enrolled at two sites within the~     Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and~     control groups will receive a femoral nerve catheter, standard during a primary TKA. It is~     hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic~     usage, reduce pain, and allow for a quicker return to function following TKA.~   "
108108|NCT01641211|"~     This is a feasibility study to determine whether the Expanding Networks for Latinos through~     Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized,~     controlled trial (RCT) to improve their asthma medication device technique. Children will be~     recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch~     device technique videos (experimental group; n=50) or a nutrition video (control group,~     n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device~     technique will be assessed before and after the visit. Process evaluation data will also be~     collected. The investigators hypothesize that children in the intervention group will have~     better device technique post-intervention than the control group.~   "
108089|NCT01641458|"~     The fluoropyrimidines 5-fluorouracil (5FU) and capecitabine (Cp) are among the most commonly~     used anticancer drugs. Still, there is much controversy about the correct dosing, and the~     fact that a minority of patients experience severe, sometimes even lethal toxicity following~     treatment. One important factor predisposing patients to severe toxicity is deficiency in~     the 5FU-catabolic enzyme dihydropyrimidine dehydrogenase (DPD). Our group identified 4 DPD~     risk alleles in over 300 Swiss cancer patients, that resulted in a 8-times increased risk of~     experiencing severe toxicity from 5FU or Cp. In patients receiving 5FU as a continuous~     infusion, there are accumulating data that keeping the AUC of 5FU between 20-30 mg*h/L is~     beneficial in terms of treatment toxicity and activity. In this study, patients carrying at~     least 1/4 DPD risk alleles will receive a 50% dose reduction of either 5FU or Cp, with the~     potential of later dose increases in the abscence of severe toxicity. Additionally, patients~     receiving i.v. 5FU will undergo therapeutic drug monitoring at the end of the 2-day~     continuous infusion, with subsequent dose adaptations to target a 5FU AUC of 20-30 mg*h/L.~     The primary study objective is to reduce the incidence of severe treatment-related toxicity~     from 13% (in historical controls) to 5% in study patients.~   "
108090|NCT01641445|"~     This study will help to determine whether the medication, topiramate, reduces alcohol use~     among adolescents with alcohol dependence. It will also help answer the question, How does~     topiramate reduce drinking in teenagers? Understanding how topiramate may reduce drinking~     in adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and~     help to identify additional medications that may hold promise for improving treatment~     outcomes for youth.~   "
108091|NCT01641432|"~     Problems with attention are a common and debilitating consequence of brain injury. Studies~     show that poor attention is the number one predictor of poor cognitive functioning one year~     post-injury. This is due to the fact that attention is a necessary component of more complex~     cognitive functions such as learning & memory, multi-tasking and problem solving. In many~     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial~     neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery~     of the brain is plastic and remodeled throughout life by learning and experience, enabling~     the strengthening of cognitive skills or abilities. The investigators own research has shown~     that brief, daily computerized cognitive training that is sufficiently challenging,~     goal-directed and adaptive enables intact brain structures to restore balance in attention~     and compensate for disruptions in cognitive functioning.~   "
108092|NCT01641419|"~     The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases~     the duration of pain relief provided by popliteal sciatic nerve block performed for~     foot/ankle surgery. The investigators also want to find out if there is a difference between~     4 and 8 mg dose of dexamethasone.~   "
108093|NCT01641406|"~     The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast~     carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate~     the utility of the PET scan to guide the neoadjuvant treatment and the utility of the~     Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the~     clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients.~     To evaluate the prognostic factors associated associated with pathological response as~     measured by the residual cancer burden tool.~   "
108094|NCT01641393|"~     The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as~     compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with~     Cystic Fibrosis in subjects 12 years of age and older.~   "
108095|NCT01641380|"~     While there have been major declines in teenage pregnancy around the country, Baltimore,~     Maryland has continued to experience increases over the last several years. Access and~     adherence to contraception has been found to be a major contributor to declines in teen~     pregnancy worldwide. The aim of this proof of concept pilot project is to determine the~     feasibility and acceptability of a text messaging reminder system for communicating with~     urban adolescents using Depo-Provera for long-acting contraception. We will randomize urban~     adolescent girls who have elected Depo-Provera for ongoing contraception to receive either~     standard counseling and clinic appointment reminders or a text messaging (DepoTEXT)~     follow-up intervention. Participants in the DepoTEXT intervention will receive reminders for~     clinic visits and encouraging messages each month for STI prevention. The primary outcomes~     being measured are 1) delivery of text messages 2) preliminary effectiveness for improving~     adherence 3) patient satisfaction with the text messaging program.~   "
108096|NCT01641367|"~     The study is being done to:~        -  test a strategy of using a resistance test to choose anti-HIV drugs. Resistance tests~          look at the HIV in your blood to see which drugs might work best to lower your HIV~          infection.~        -  see how well combinations of new anti-HIV drugs work to lower HIV infection~        -  see if taking new anti-HIV drugs together is safe and tolerable~        -  see if text messages improve people's anti-HIV drug-taking behavior (only at sites~          doing the adherence study)~        -  in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare~          how these drugs act in the body~        -  in Step 3, to see how people do after they stop having frequent clinic visits as part~          of a research study~   "
108097|NCT01641354|"~     Knock knees or genu valgus necessitates in some children corrective surgery with partial~     closure of the growth plate at level of the knee.~   "
108098|NCT01641341|"~     Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced~     randomization and a cross-over to active treatment for placebo treated individuals who do~     not respond to the placebo treatment. Data collected will help determine the feasibility of~     the study design in primary care offices. Patient outcome data will provide a more precise~     estimate of power for a larger, classic randomized trial to determine if such a study can be~     reasonably undertaken within primary care practices.~      Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS~     tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics~     (GDx) test on treatment, and 3) observe and track patients' health, quality of life and~     clinical outcomes related to IBS during the study period.~   "
108238|NCT01639469|"~     This project is investigating whether a one-year in-home exercise program will reduce the~     rate of falls and improve strength and quality of life in patients with Parkinson's disease.~   "
108099|NCT01641328|"~     Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually~     among older adults, in which a person notices a decline in attention or memory, and performs~     worse than normal on cognitive tests of such. People with MCI are more likely to develop~     Alzheimer's disease or related dementia than others their same age, and so MCI is thought of~     as an early warning sign of progressive cognitive decline.~      While some forms of MCI may be brought about by purely genetic causes, other cases may be~     due to a withdrawal of cognitive engagement with the world. In these cases, a rigorous~     program of cognitive training may be beneficial, halting or reversing symptom progression.~      The current study will evaluate a multifaceted cognitive activation program on older adults~     with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a~     total of 100 hours of training. Training consists of meditation exercises for broad~     attention activation, Tai Chi exercises to integrate cognition with body awareness, and~     cognitive training through computerized attention, memory, and problem solving exercise.~      Subjective impressions and objective measures of cognitive ability will be measured before~     and after the intervention. The investigators will also examine effects on mood and levels~     of daily function. Results will be compared to a waitlisted control group. The control group~     will subsequently be entered into a home-based version of the program for 10 weeks, with~     assessment before and after training, to look at the importance of the group meeting dynamic~     in promoting cognitive change.~   "
108100|NCT01641315|"~     Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to~     be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen~     with rabies immunoglobulin have never been studied in the aspect that the immunity level~     would above the protective level required by WHO (0.5 IU/ml) for at least a year period.~     This study would access this subject.~   "
108101|NCT01641302|"~     The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an increase of intracranial pressure (ICP). Previous studies have~     proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD)~     correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased~     ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.~   "
108102|NCT01641289|"~     Blackwater fever, characterized by intravascular haemolysis and hemoglobinuria, is an~     important cause of renal impairment and mortality in severe malaria caused by Plasmodium~     falciparum. The largest malaria clinical trials report blackwater incidences of 5-7% in~     Asian adults and 4% in African children with severe malaria treated with artesunate or~     quinine. The prevalence of blackwater fever in Chittagong, Bangladesh is 15% with associated~     rates of renal failure and mortality of 42.9% and 14.2% respectively.~      The fundamental characteristic of blackwater fever is the presence of intravascular~     hemolysis of both infected and uninfected erythrocytes and release of free haemoglobin. The~     cytotoxic free haemoglobin present can cause severe oxidative damage as a result of haem~     redox cycling yielding ferric and ferryl heme, which generate radical species that induce~     lipid peroxidation and subsequent production of F2-isoprostanes (F2-IsoPs). Evidence~     suggests that F2-IsoPs generated by the hemoprotein-catalyzed oxidation of lipids are~     responsible for the oxidative damage and vasoconstriction associated with renal injury in~     haemolytic disorders and rhabdomyolysis.~      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol is a~     potent inhibitor of hemoprotein-catalyzed lipid peroxidation by reducing ferryl heme to its~     less toxic ferric state and quenching globin radicals. In a recent proof of concept trial,~     paracetamol at therapeutic levels was shown to significantly decrease oxidant kidney injury,~     improve renal function and reduce renal damage by inhibiting the hemoprotein-catalyzed lipid~     peroxidation in a rat model of rhabdomyolysis-induced renal injury. Since adults with severe~     malaria demonstrate increased concentrations of cell-free haemoglobin, and urinary F2-IsoPs,~     the investigators hypothesize that this novel inhibitory mechanism of paracetamol may~     provide renal protection in this population by reducing the hemoprotein-induced lipid~     peroxidation. As there is currently no consensus that exists concerning adequate medical~     treatment for blackwater fever, the potential application of this safe and extensively used~     drug would be of great benefit.~   "
108103|NCT01641276|"~     The propose of this study is to identification of a group of specific amplitude-modulated~     frequencies of low intensity electromagnetic fields that is associated with biofeedback upon~     exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.~   "
108104|NCT01641263|"~     The objective of this study is to evaluate the ability of a behavioral intervention,~     cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints,~     depression recurrence, and cellular and genomic markers of inflammation in older adults with~     sleep complaints who have a prior history of depression. The investigators aim to: 1)~     evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and~     subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year~     follow-up; 2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms~     and depression episode(s) over a two-year follow-up. The investigators will also secondarily~     examine the effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a~     two-year follow-up, and explore whether markers of inflammation and cytokine genes can~     explain variability in the risk of depression recurrence in those older adults receiving~     CBT-SQ vs. SS. The present study is highly significant by being the first study, to the~     investigators knowledge, to focus on the prevention of depression in community dwelling~     older adults who have a history of depression, and by targeting sleep disturbance, a~     modifiable risk factor to prevent depression recurrence.~   "
108105|NCT01641250|"~     This multi-center, open-label study will evaluate the safety, pharmacokinetics,~     pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in~     patients with acute myelogenous leukemia. In Part A, patients will receive multiple~     escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus~     up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time~     on study treatment is until disease progression or unacceptable toxicity occurs.~   "
108106|NCT01641237|"~     The proposed study will evaluate the performance of fluoride delivered from a new dentifrice~     formulation without potassium nitrate. It will also evaluate the dose-response to fluoride~     by testing four dentifrices covering a range of sodium fluoride concentration.~   "
108107|NCT01641224|"~     The purpose of this study is to test the efficacy and safety of pinaverium and an herbal~     medication for irritable bowel syndrome (IBS). Pinaverium has been in many countries, but~     there is no randomized, double-blind, large sample size, and placebo-controlled study on~     this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and~     contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is~     that the two remedies are effective and safe for IBS treatment when tested by modern~     clinical standards and criteria.~   "
108662|NCT01633944|"~     The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film~     is effective in treating opioid-naive subjects, with moderate to severe chronic low back~     pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended~     period of time.~   "
108109|NCT01641198|"~     Between 1992 and 1996, 58 subjects were enrolled in a randomised, short and long term~     superiority single centre prospective clinical trial. Each subject was randomly assigned to~     receive 5 mandibular endosseous implants of 3 types (B, SW, SC). All subjects were aged~     between 25 and 56 years, were in excellent physical and mental health, non smokers, not~     taking any prescribed medication, not suffering from TMJ or facial pain abnormalities and~     were treated with complete removable dental prostheses of both jaws for at least one year.~     All subjects were skeletal class I intermaxillary relationship and had at least 1 cm of bone~     height between the superior and inferior cortical tables as well as at least 6 mm. of~     buccal-lingual bone width in the anterior mandibular region between the mental foramina. All~     subjects had type 2 and/or type 3 mandibular bone quality in this area and specifically~     requested a fixed complete dental prosthesis over the mandibular implants accompanied by a~     conventional complete removable maxillary prosthesis. Standardized radiographs of the~     osseous healing around the abutment-implant interface were taken at 12 months after~     prostheses insertion and are to be taken presently and in future at 15 years or more after~     prostheses insertion using the same standardized protocol and equipment. The 3 implant~     types, B, SW and SC, are approved and commercially available in North America. They are~     paralleled, screw endosseous and are composed of commercially pure titanium. Two of the~     implant types are almost identical in design except that one of the implant types (SW) has~     an acid etched microtextured surface versus the smooth, machined non acid etched surface of~     the other (B). The third implant type (SC) possess a very similar design to the others but~     its smooth-surfaced collar is narrower and longer than the smooth surfaced collars of the B~     and SW implant types which are identical. The SC implant type also has an acid etched~     microtextured surface identical to that of the SW implant.~   "
108110|NCT01641185|"~     The purpose of this study is to evaluate the safety and feasibility of primary~     hypofractionated irradiation of the prostate with carbon ions or protons using the raster~     scan technique.~   "
108111|NCT01641172|"~     Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a~     prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes.~     These chemosensory changes are distressing for patients and can lead to changes in appetite,~     food choice, and nutrient intake. These changes can result in malnutrition and weight loss.~     Possibly, also unhealthy eating patterns can be developed due to these taste and smell~     changes, given the high prevalence of obesity among survivors of certain cancer types. The~     primary objective is to investigate the nature, prevalence, and duration of taste and smell~     changes in patients with disseminated testicular cancer treated with cisplatin based~     chemotherapy.~   "
108112|NCT01641159|"~     The purpose of this study is to evaluate whether or not buspirone is effective in preventing~     relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to~     enter outpatient treatment upon inpatient/residential discharge.~   "
108113|NCT01641146|"~     HIV continues to spread among Black men who have sex with men (MSM), but few interventions~     target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories~     of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk~     sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic~     stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular,~     neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS~     progression. The purpose of this study was to test an HIV risk reduction intervention,~     guided by the Social Learning Theory, the Ecological Model, and the concept of allostatic~     load, a composite of the cumulative effects of stress on biological systems including~     psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual~     Health Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with~     histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected~     anal and vaginal sex and number of sex partners) and negative psychological symptoms of~     depression and PTSD. Links between these outcomes and biomarkers of stress were also~     explored. Randomization to either the ES-HIM or a health promotion control group occurred~     with study participants assessed at baseline, post, 3- and 6-months.~   "
108114|NCT01641133|"~     The primary aim of this study is to assess the reactogenicity of Synflorix™ vaccine and~     Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with either~     Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. In~     addition, this study aims at assessing the safety, reactogenicity, immunogenicity and~     antibody persistence (approximately 8-11 months following primary vaccination) of the~     Synflorix™ vaccine and Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of~     age with either Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™,~     respectively. This study also aims at assessing the safety, reactogenicity and~     immunogenicity of the Synflorix™ vaccine when given as a booster dose at 12-15 months of age~     following primary vaccination at 2 and 4 months of age with either Synflorix™ vaccine or~     Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively.~   "
108115|NCT01641120|"~     The purpose of this study is to evaluate patients' views when injecting Avonex~     intramuscularly.~   "
108116|NCT01641107|"~     Drug resistance resulting from emergence of Imatinib-resistant BCR-ABL clones is a~     significant problem in Ph positive ALL patients because after a very good initial response~     to one TKI inhibitor, many patients relapse within one year, relapse being almost always~     associated with a BCR-ABL kinase domain point mutation. The patients who relapse after~     treatment with one TKI can be rescued to remission with another TKI, but the second~     remission is usually shorter than the previous one. A more potent TKI inhibitor, and~     pan-active not only on all the BCR-ABL variants (including the second generation TKI~     resistant T315I mutant), but also on others molecular targets can do better. In this~     context, Ponatinib is a novel synthetic orally active tyrosine kinase inhibitor (TKI),~     specifically developed to inhibit BCR-ABL, the fusion protein that is the product of the~     Philadelphia chromosome (Ph) in chronic myeloid leukemia (CML) and in a subset of acute~     lymphoblastic leukemia (Ph+ ALL). It potently inhibits the BCR-ABL protein as well as~     mutated forms of the protein that arise in patients resistant to prior therapies with TKIs.~     Ponatinib has been demonstrated to inhibit all the mutations that have been detected so far,~     in vitro and in vivo and to uniformly suppress the emerge of single-mutant clones in a~     mutagenesis assay. In the Phase II study, 41% of Philadelphia chromosome positive acute~     lymphoblastic leukemia patients treated with Ponatinib achieved major hematologic response,~     47% had a major cytogenetic response, 38% obtained a complete cytogenetic response, showing~     that Ponatinib provides significant benefit despite previous intolerance or refractoriness~     to other TKIs. The Phase I trial showed that patients with a more recent diagnosis had~     increased rates of major molecular response: 79% for 14 patients with 0 to 5 years since~     diagnosis vs. 29% for 14 patients with more than 5 to 9 years since diagnosis (P=0.02) and~     27% for 15 patients with more than 9 to 24 years since diagnosis (P=0.009). These~     characteristics support the hypothesis for a role of Ponatinib not only in patients~     resistant to prior TKI therapy but also in untreated ALL Ph+ patients, in order to prevent~     the emergence of resistant caused by the selection of mutated Ph+ clones and in order to~     avoid rapid progression of the disease.~   "
108127|NCT01640964|"~     The main purpose of this exploratory study was to investigate the effect of serelaxin~     (RLX030) infusion on the hepatic and renal circulation in patients with compensated~     cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic~     resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic~     portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check~     procedure (study part B), to determine the acute haemodynamic response to serelaxin~     (RLX030).~   "
108663|NCT01633931|"~     The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat~     patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.~   "
108117|NCT01641094|"~     Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million~     people. The previous standard of care therapy of chronic HCV patients consists of~     pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in~     only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has~     previously proven to offer therapeutic options to previous non-responders to the standard of~     care. Although, not all chronic HCV patients benefit from telaprevir and it is still not~     known why certain patients are also non-responsive to this triple therapy. In this study we~     try to understand why certain patients are also non-responsive to telaprevir, how triple~     therapy modulates the responsiveness to IFN-α and what the immunological consequences are of~     treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of~     HCV-RNA levels.~   "
108118|NCT01641081|"~     The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol~     fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to~     moderate asthma.~      This study will include a screening visit followed by a 4 month treatment period.~   "
108119|NCT01641068|"~     The purpose of this study is to examine thinking abilities, mood, and quality of life in~     cancer survivors before and after an 8-week group-based memory and thinking skills workshop.~     Research participants will include people treated for cancer in the past. Researchers would~     like to know if there is a relationship between baseline performance on timed attention and~     memory tasks before receiving memory and thinking skills workshop designed to improve~     cognition, and performance on such tasks after the workshop.~   "
108120|NCT01641055|"~     The purpose of this study is to compare the possible health benefits of intake of proteins~     and peptides (small proteins) from salmon, herring and cod on glucose tolerance and~     inflammatory markers in overweight and obese adults. Overweight and obese subjects often~     have reduced glucose tolerance and a chronic low-grade inflammation, and previous findings~     from a study on cod proteins suggested that both glucose tolerance and immune function were~     improved.~   "
108121|NCT01641042|"~     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of~     the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal~     disease and compare it to its activity in healthy subjects.~   "
108122|NCT01641029|"~     Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and~     vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000~     annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over~     80% of these infections. Over the last two decades, E. coli resistance has emerged to~     commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole~     (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing~     extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand~     the evolution and current state of antibiotic resistance among E. coli urinary tract~     isolates so as to better inform treatment decisions, the investigators propose to conduct an~     investigation to: a) determine the prevalence of antimicrobial resistance among E. coli~     causing acute pyelonephritis in various patient groups, and specifically healthy~     community-dwellers with uncomplicated infections, b) determine the specific prevalence of~     fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk~     factors for fluoroquinolone and ESBL-producing E. coli infections.~   "
108123|NCT01641016|"~     The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT)~     in the management of HIV-infected young people who have responded well to antiretroviral~     therapy (ART) and to determine whether young people with chronic HIV infection undergoing~     Short-Cycle Therapy of five days on ART and two days off maintain the same level of viral~     load suppression as those on continuous therapy, over 48 weeks.~      To assess the advantages and disadvantages of the strategy, the incidence of toxicities,~     immunological control, resistance mutations, acceptability, quality of life and adherence to~     the randomised strategy will also be compared.~      Importantly, because of insufficient data on short-term viral load rebound after stopping~     ART in this population, the trial will incorporate an initial pilot phase in selected~     centres, to assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles~     of participants on the SCT strategy.~   "
108124|NCT01641003|"~     1. to evaluate insoluble fibrinogen particles (iFP), as a tool for harvesting, growing and~          transferring attachment-dependent cancer stem cells and comparing it to the standard~          method ( coated plate) .~        2. to evaluate whether using iFP for growing CSC can yield better results of isolating and~          enriching CSCs from fresh tumors than other conventional methods~   "
108125|NCT01640990|"~     This study is a single dose evaluation using an open label dose escalating design. Cohort1~     will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion~     over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5~     hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg).~     Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2~     hours after cessation of the intravenous infusion. PK measurements and measurement of~     erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30~     minute intervals during the infusion of GW328267X up to and including 1 hour after cessation~     of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be~     done.~      Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in~     Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision~     to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the~     Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1.~     It is planned that the maximum total dose given to any subject will not exceed 150mcg.~     Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this~     additional Cohort will be the same as that described for Cohort 1.~   "
108126|NCT01640977|"~     The study is a prospective non-concurrent controlled observational evaluation of short-term~     operative results. As such, study sites will capture perioperative (through 6-week~     postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar~     interbody fusion) procedures. After this open experience, these same sites will capture the~     corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF~     variant was performed. The data from both series of cases will be compiled to identify~     similarities and differences between the techniques.~   "
108128|NCT01640951|"~     CAIN457A2304E1 is an extension study to two ongoing phase III studies, CAIN457A2304 and~     CAIN457A2307 (core studies). This extension study is planned to collect up to two years of~     long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval~     regimen and the retreatment at start of relapse regimen. All subjects completing Week 52 of~     CAIN457A2304 and Week 40 of CAIN457A2307 will be eligible to participate in this extension~     study. Week 40 of the CAIN457A2307 study is the end of maintenance visit (EOM) and is~     equivalent to the Week 52 (EOM) of the CAIN457A2304 core study. Therefore, all subjects~     entering the CAIN457A2304E1 study will have received 52 weeks of treatment in their previous~     study / studies. In this extension study, the prefilled syringe (PFS) liquid formulation of~     secukinumab will be used.~   "
108129|NCT01640925|"~     This prospective, randomized, controlled trial will compare the incidence of nosocomial~     infections (composite of primary bloodstream infections, catheter-associated urinary tract~     infections, ventilator-associated pneumonia, and surgical site infections) that occur in~     intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who~     receive standard bathing (soap and water or non-medicated cloths).~   "
108130|NCT01640912|"~     The primary purpose of this study is to evaluate the safety and tolerability of a single~     intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that~     will later be removed during an elective abdominoplasty. The effect of RXI-109 versus~     placebo on scarring at these incision sites will be evaluated visually and histologically.~   "
108131|NCT01640899|"~     The aims of this study were to evaluate the effects of insoles on pain, daily activities and~     physical activity level, and to investigate the relation between satisfaction with the~     insoles and their actual use in individuals with LE pain.~   "
108132|NCT01640886|"~     In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and~     methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's~     bacteriophage-based diagnostic platform.~   "
108133|NCT01640873|"~     This study will assess the initial safety, tolerability, pharmacokinetics, and~     pharmacodynamics of MK-8655, after single and multiple daily oral administrations to~     participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting~     plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.~   "
108134|NCT01640860|"~     This study is designed to determined the feasibility and safety in advanced esophageal~     cancer treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end~     points were clinical best response and response rate and secondary endpoints were~     progression free survival and overall survival.~   "
108135|NCT01640847|"~     This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in~     combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain~     for patients with painful bone metastases.~   "
108136|NCT01640834|"~     This study involves taking a single dose of 100 mg or 300 mg LY2409021 or placebo (an~     inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug~     will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes~     a 7 day hospitalization period at the clinical research unit (CRU) and will involve~     screening within 30 days of the start of the study as well as telephone consultations within~     5 days after discharge from the CRU.~   "
108137|NCT01640821|"~     The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence~     of overweight and obesity among young people and adults by 2012. One of the five priorities~     of the PAG is to improve health services for individuals with weight-related issues. The~     development and implementation of sustainable weight-control strategies however remains a~     challenge, since weight loss is often regained by the majority of individuals over time.~     Health-At-Every-Size (HAES) interventions, which are mainly focusing on health rather that~     weight, have been proposed as an interesting alternative for individuals, mainly women, who~     are struggling with weight-related issues. Based on the HAES, Choisir de maigrir? (CdM?)~     program has been clearly identified by the PAG as one of the actions for improving health~     services and Quebec's government has already started a massive dissemination of the CdM?~     program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the~     effectiveness and readiness of the program for a broad dissemination. The present research~     proposal falls directly within the scope of the PAG recommendation and the investigators~     general objective is to develop a population-based understanding of the effectiveness of the~     CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in~     a natural setting.~   "
108138|NCT01640808|"~     The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in~     inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the~     disease, with the recurrence-free survival as the primary endpoint, in a multi-center,~     randomized, double-blind, placebo-controlled, parallel-group comparison study.~   "
108139|NCT01640782|"~     Open label, randomised, multicenter, superiority study for efficacy. Patients with~     histologically proven adenocarcinoma of the stomach or gastroesophageal junction without~     gross or microscopic evidence of residual disease after surgery with curative intent and~     fulfilling all the inclusion/exclusion criteria are eligible for this study.~   "
108140|NCT01640769|"~     Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal~     myocardial targets will result in improved clinical response to CRT using Left Ventricular~     remodeling criteria.~   "
108141|NCT01640756|"~     To establish the safety and performance of the AqueSys Microfistula Implant in eyes with~     refractory glaucoma.~   "
108142|NCT01640743|"~     The objective of the study will be to evaluate the effect of different therapeutic~     immunosuppressive strategies currently employed in common clinical practice on regulatory T~     lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR~     inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but~     it can also lead to mid-term formation of a high amount of regulatory T cells and,~     consequently, a high grade of tolerance.~   "
108143|NCT01640730|"~     This study is for patients with advanced non small cell lung cancer that has progressed~     despite standard of care. The purpose of the study is to see if Kanglaite injection has any~     effect on survival.~   "
108144|NCT01640717|"~     The primary objective is to assess safety and efficacy data of Escherichia coli-derived cPMP~     in patients with molybdenum cofactor deficiency (MoCD).~   "
108145|NCT01640704|"~     Numerous studies have examined potential causes for the racial differences in HTN prevalence~     and severity including baseline insulin levels, sympathetic nervous activity, intracellular~     calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have~     been no studies examining the relationship of physician adherence to JNC guidelines to~     racial disparities in outcomes from HTN; nor have there been published studies examining the~     use of interventions such as computerized decision support tools or case-management to~     improve JNC adherence with the goal of reducing racial differences in blood pressure~     control. The aims of this study are: 1) To determine if physician's prescribing practices~     for HTN medications adhere to JNC guidelines for drug therapy.~      2) To determine if there are variations in adherence to JNC guidelines based on patient~     race.~      3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To~     determine if the use of computerized medical reminders improves adherence to JNC guidelines.~   "
108146|NCT01640691|"~     The objectives of this single arm study are to evaluate the immune response and safety~     profiles of two injections of an inactivated whole-virion vaccine containing aluminum~     hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.~   "
108147|NCT01640678|"~     Autologous epidermal cell suspension grafting is an effective method of surgical treatment~     in vitiligo, which is suitable for treating larger areas with better cosmetic results as~     compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita~     Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which,~     compared to other forms of autologous epidermal cell suspension grafting, is easier in use~     showing similar results. Furthermore, the ReCell device needs no laboratory facilities.~     Therefore, it is promising for patients with large vitiligo and piebaldism lesions.~      Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell~     suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser~     abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary:~     to assess the practical aspects and patients satisfaction of autologous epidermal cell~     suspension grafting with the ReCell device.~      Study design: Prospective observer blinded randomized controlled pilot study. Study~     population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are~     under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic~     Medical Centre University of Amsterdam.~      Methods: Three depigmented regions on the trunk or proximal extremities will be randomly~     allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser~     abrasion, or no treatment. After the transplantation, UV-treatment according to the standard~     treatment protocol of the NIPD will be started on all sites and continued for 3 months.~     Three and six months after grafting, the percentage of repigmentation of the lesions will be~     assessed.~   "
108148|NCT01640665|"~     The purpose of this study is to find the maximum tolerated dose of the combination of two~     drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug~     which is used to treat certain cancers. The drug Capecitabine is approved to treat patients~     with advanced breast cancer as well as early stage colon cancer.~   "
108149|NCT01640652|"~     In this study the investigators are testing a new vaccine against Neisseria meningitidis,~     the leading infective cause of childhood death in the UK. This bug (also known as~     meningococcus) can infect the lining of the brain (meningitis) or the blood stream~     (septicaemia) and can affect all ages, but especially children, adolescents and young~     adults.~      The bug is classified into different groups based on its outer capsule (or shell), and this~     study will test a new vaccine to protect against group B meningococcus (MenB) disease, which~     is the most common type in the UK.~      Vaccines are given to prepare the immune system to fight an infection. Vaccines work by~     stimulating the immune system to produce specialised proteins (called antibodies) and white~     blood cells designed to kill the bug later in life if needed.~      Vaccines against other types of meningococcus have been developed and saved many lives.~     However MenB is different because its outer capsule does not stimulate the immune system~     very effectively. There is therefore no broadly effective vaccine against MenB disease.~   "
108150|NCT01640639|"~     Several studies have shown that inflammation and matrix degradation have pathogenic effects~     on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the~     matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling~     process.~      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory~     and antioncogenic properties that could be of benefit in case of congestive heart failure~     (CHF).~      Previous, small investigations have shown an improvement in left ventricular ejection~     fraction and a favorable cardiac remodeling during thalidomide therapy.~   "
108151|NCT01640626|"~     There is a sever lack in application of health education intervention for Soil Transmitted~     Disease (STH) in rural communities and in school children among Orang Asli in Pahang in~     Malaysia, and also there is a lack of information on the effect of different health~     education aspects on STH control in Malaysia, so the investigators think that introducing~     such new national educational package and for the first time in Malaysian's school will help~     children to make some behavior changes specially for the school children aiming to use these~     children as an educator agents to their families and preschool brothers and sisters, to~     build a base for this issue and to reduce STH intensity in these rural areas, which in turn~     will determine the best approach to health education intervention to be applied to other~     rural areas in Malaysia.~   "
108152|NCT01640613|"~     The aim of this study is to describe technique, efficiency, safety and satisfaction of~     ultrasound guided intermediate cervical plexus block for carotid endarterectomy.~      The investigators present a simple approach for carotid regional anaesthesia by an anterior~     way that has not been published yet.~   "
108153|NCT01640600|"~     The purpose of this project is to conduct a follow-up study with women that had participated~     in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink~     and Blue Kids Study is a follow-up study with the mothers and also with the children they~     were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8~     years old, which is a perfect time to look at developmental outcomes in children. This study~     will look at children with exposure to nicotine or antidepressants during pregnancy, as well~     as children who were not exposed. The investigators hypothesis is that children who were~     exposed to either nicotine or antidepressants in pregnancy will have poorer developmental~     outcomes than children who were not exposed. The investigators are also interested in~     determining whether nicotine exposure or antidepressant exposure results in poorer outcomes.~      The investigators specific aims are:~        1. To determine whether pre-school and school aged offspring exposed to maternal cigarette~          smoking or antidepressants during pregnancy are more likely to have social-emotional~          problems compared to children who were not exposed to cigarettes or antidepressants~          during pregnancy.~        2. To determine whether pre-school and school aged children who were exposed to prenatal~          maternal cigarette smoking or antidepressants during pregnancy display cognitive~          impairments as compared to children who were not exposed to either prenatal maternal~          cigarette smoking or antidepressants.~        3. To determine if pre-school and school aged children who were exposed to maternal~          prenatal cigarette smoking or antidepressants display impaired motor development as~          compared to children who were not exposed to maternal cigarette smoking or~          antidepressants in pregnancy.~   "
108154|NCT01640587|"~     In camps for displaced persons located along the Thai-Myanmar border, mefloquine and~     artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen~     of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in~     1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day~     63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite~     susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The~     proportion of patients with parasitaemia persisting on day-2 increased significantly from~     4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated~     with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002).~     MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19,~     p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI,~     91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy~     number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).~      Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in~     January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance.~     A more recent analysis of parasite clearance data collected prospectively in patients with~     uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite~     clearance rates over the last decade suggesting a decline following the same trajectory as~     in Western Cambodia but with a time lag of a few years.~      Surveillance data collected in 2011 have shown a dramatic and worrying decline in efficacy~     of MAS3, albeit in a small number of patients. This decline in efficacy of mefloquine +~     artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine.~     The other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best~     option to replace mefloquine-artesunate since it is thought that it remains effective in the~     presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no~     special dietary modification to ensure adequate absorption.~      In this study it is hypothesised that efficacy of DP (estimated to be 95%) will be~     significantly higher than that of MAS3 (estimated to be 65%), therefore the investigators~     propose to conduct a randomised controlled trial between DP and MAS3 for the treatment of~     P.falciparum.~   "
108155|NCT01640574|"~     In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden~     of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume~     increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the~     latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability~     and compounds the economic burden of those with symptomatic disease. The only widely~     available treatment for hypnozoites is primaquine, which, because of challenges with~     tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed~     for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood~     stages of Pv, however, there are concerns about increasing parasite resistance. Alternative~     treatments, such as artesunate, should be considered in the future of the treatment of blood~     stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be~     emphasized so that transmission of Pv can be controlled.~      This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium~     vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine~     may have synergistic effects when used with primaquine and due to its long half-life may~     delay the first relapse of vivax malaria. In contrast, artesunate does not have documented~     interactions with primaquine and has a very short half-life, thus, presumably will have no~     impact on first relapse. Combining primaquine with these two anti-malarials may lead to an~     alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to~     a more practical and efficacious therapy.~   "
108156|NCT01640561|"~     Early childhood (up to age 5 yrs) is a period of dramatic change in the cognitive,~     emotional, social, and behavioral domains; children continuously progress by observing and~     interacting with the world around them. In the face of economic instability and nutritional,~     medical and educational deprivation, HIV-affected very young children are the most~     vulnerable HIV subgroup globally because their families are often the most vulnerable, with~     little margin for sustaining a favorable developmental milieu for the child. Through~     strategic caregiver interventions during this sensitive period of child neurodevelopment,~     our study findings have the potential for positively re-directing the developmental~     trajectories of tens of millions of HIV-affected children globally.~   "
108157|NCT01640548|"~     This non-interventional, retrospective, cross sectional chart review study will evaluate the~     management of rheumatoid arthritis patients with a biologic in monotherapy. Data from~     eligible patients will be collected from the patient's last visit on the prior rheumatoid~     arthritis treatment and from the most recent visit for the biological monotherapy.~   "
108158|NCT01640535|"~     The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast~     Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and~     Montelukast monotherapies and to compare the safety and tolerability of Concomitant~     Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and~     Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.~   "
108159|NCT01640522|"~     The purpose of this study is to test the efficacy of a collaborative care intervention to~     manage cancer-related symptoms and improve health related quality of life in patients~     diagnosed with hepatobiliary carcinoma.~   "
108160|NCT01640509|"~     The purpose of this study is to prove the safety and acceptability of treatment with the~     Synchrotron radiation by medium-term medical follow-up of the patients.~   "
108161|NCT01640496|"~     The purpose of this study is to test blood and tissue samples of people with Ulcerative~     Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is~     being done because it could lead to the development of new treatment for people with~     Inflammatory Bowel Disease (IBD).~   "
108162|NCT01640483|"~     Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for~     Major Depressive Disorder are differentially efficacious dependent on personality traits of~     the patient. More specifically, supportive techniques are hypothesized to be more~     efficacious for dependent patients, interpretative techniques to be more efficacious for~     self-critical patients, and mixed supportive/interpretative techniques to be more~     efficacious for mixed dependent/self-critical patients. Moreover, supportive techniques are~     hypothesized to impact on depressive symptoms through increased relational capacities while~     interpretative techniques impact through increased self-understanding.~      These hypotheses are tested in an experimental single case design with three dependent,~     three self-critical and three mixed dependent/self-critical depressive patients. These~     patients go through a time-limited (50 sessions) experimental treatment which exists of a~     sequence of four A phases (control conditions), one B phase (supportive techniques only),~     one C phase (interpretative techniques only), and one BC phase (mixed~     supportive/interpretative techniques).~   "
108664|NCT01633918|"~     The purpose of this study is to find out whether an Internet-supported FeetEnergy approach~     and two home works integrated in three health education lessons can increase adolescents'~     active commuting to school and leisure-time physical activity and decrease their screen~     time.~   "
108163|NCT01640470|"~     Many individuals with mobility limitations, especially those who are older and have more~     severe impairments, use a combination of assistive devices and personal assistance to meet~     their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers,~     bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social~     participation (basic and instrumental activities of daily living) among these individuals~     and may decrease their dependence on human assistance. Although some research has reported~     beneficial outcomes of AT use, few studies have used controlled experimental designs.~     Furthermore, the results are often difficult to interpret because the AT interventions are~     only vaguely described. Another concern is that many individuals receive help from others,~     but scant attention has been paid to the impact of AT on caregivers. This neglect produces~     an incomplete portrayal of the effect of AT interventions. The proposed study addresses~     these deficiencies by evaluating the effects of a formalized dyadic AT intervention on~     individuals with mobility limitations and on their caregivers. The Assistive Technology~     Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment~     of participants' current AT; the negotiation and implementation of a personal AT plan with~     the participants and their caregivers; and the provision of AT devices, non-structural home~     modifications, and device training.~      Objectives:~        1. To determine the efficacy of the Assistive Technology Provision, Updating and Training~          intervention for assistance users and for their caregivers.~        2. To explore how the intervention is experienced by these individuals and to help explain~          the study findings.~      General Hypotheses:~      The investigators anticipate this intervention will increase the daily activities and social~     participation of individuals with mobility limitations; decrease the psychological and~     physical demands on caregivers; and reduce the amount of caregiving required.~      Methodologies:~      This research will use a combination of quantitative and qualitative methods. The~     quantitative portion will be an experimental, single-blinded study in which the~     investigators randomly assign participants to either the ATPUT or a customary care group.~   "
108164|NCT01640457|"~     NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and~     efficacy in the repair of a herniated disc with an indication for an elective~     sequestrectomy, and of the adjacent degenerated disc, if present. The objective of this~     clinical study is to provide basis for a confirmatory study design (endpoints,~     methodologies) (Phase II), and to develop a safety profile (Phase I). This study further~     aims at developing and validating known and new biologic markers for the quality and~     clinical efficacy of the product as requested in the context of identity, purity and potency~     characteristics of the medicinal/investigational product.~   "
108165|NCT01640444|"~     The purpose of the study is to explore the influence of BRAF and PIK3K status on the~     efficacy of FOLFIRI plus Bevacizumab or Cetuximab, as first line therapy of patients with~     RAS wild-type metastatic colorectal carcinoma and < 3 circulating tumor cells~   "
108166|NCT01640431|"~     The purpose of this study was to compare the efficacy of method Lumbar Segmental~     Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional~     disability and ability to activate the transversus abdominis (TrA) of individuals with~     chronic back pain caused by disc herniation.~   "
108167|NCT01640418|"~     In this study we would like to find a way to prevent sacral pressure ulcers in high-risk~     patients by the use of a Mepilex sacral dressing. The research question we would like to~     answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the~     prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk~     hospitalized patients?~   "
108168|NCT01640405|"~     The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab~     as first line treatment of patients with metastatic colorectal cancer not previously treated~     and with three or more circulating tumoral cells.~   "
108169|NCT01640392|"~     The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife~     MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old~     African American men who have sex with men (MSM). Specifically, the project will test~     whether participants of the MyLife MyStyle program will report at least a 15% absolute~     decrease in frequency of unprotected anal sex with male partners at three and six months~     post-intervention compared with the wait-list control participants.~   "
108170|NCT01640379|"~     The investigators are enrolling 350 young women 13-21years old diagnosed with pelvic~     inflammatory disease(PID) in Baltimore and randomize them to receive CHN clinical support~     using a single post-PID face-to-face clinical evaluation and SMS communication support~     during the 30. The investigators hypothesize that repackaging the recommended CDC-follow-up~     visit using a technology-enhanced community health nursing intervention (TECH-N) with~     integration of an evidence-based STI prevention curriculum will reduce rates of short-term~     repeat infection by improving adherence to PID treatment and reducing unprotected~     intercourse and be more cost-effective compared with outpatient standard of care (and~     hospitalization).~   "
108171|NCT01640366|"~     The purpose of this study is to see if the use of a single-use negative pressure wound~     therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing~     complications following breast reduction surgery and to assess the medium-term aesthetic~     appearance and quality of the resultant scar,compared with standard of care dressings.~   "
108172|NCT01640353|"~     The purpose of this study is to evaluate the use of the iFuse Implant System to treat~     degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal~     separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a~     medical device that is surgically implanted into the sacroiliac (SI) joint during a~     minimally invasive surgical procedure (one that uses a smaller incision and less damage to~     the skin and other tissues than standard surgery). The purpose of implanting the device is~     to stabilize and fuse the SI joint.~   "
108173|NCT01640340|"~     Palonosetron is different from ondansetron because it stays in the body longer and may~     prevent nausea and vomiting for a longer period of time than ondansetron. It is standard~     practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to~     prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these~     combinations are commonly used, they have never been compared to each other. The purpose of~     this study is to record the amount of nausea and vomiting, and the amount of rescue~     medication that is used with these two different anti-emetic regimens~   "
108174|NCT01640327|"~     This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity~     of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg~     derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety~     and immunogenicity data, in compliance to current EU Guidelines, with the intent of~     obtaining marketing approval of the vaccine formulation intended for use prior to the next~     influenza season in the Northern Hemisphere.~      The antibody response to each influenza vaccine antigen, was measured by hemagglutination~     inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization~     in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM)~     injection of the vaccine was evaluated in compliance with the requirements of the current EU~     recommendations for clinical trials related to yearly licensing of influenza vaccines~     (CPMP/BWP/214/96).~   "
108176|NCT01640301|"~     This phase I/II trial studies the side effects of laboratory-treated T cells and to see how~     well they work in treating patients with high-risk acute myeloid leukemia (AML),~     myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned~     after a period of improvement (relapsed), previously treated with donor stem cell~     transplant. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the~     immune system in different ways and stop cancer cells from growing. Placing a gene that has~     been created in the laboratory into a person's T cells may make the body build an immune~     response to kill cancer cells.~   "
108177|NCT01640288|"~     The purpose of this study is to develop and evaluate the usefulness of MRI using inert~     perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The~     proposed study seeks to determine regional qualitative and quantitative lung function~     information in the context of the clinical trajectory of chronic obstructive pulmonary~     disease (COPD) defined by the cross sectional cohort component. In the case of these~     perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for~     wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in~     a manner not easily achieved with any existing modality.~   "
108178|NCT01640275|"~     Previous work in animal models suggests that inhalational anesthetic agents may accelerate~     Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in~     humans. Here, the investigators propose to measure Alzheimer's disease-related neural~     markers in the cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing~     neurosurgical procedures that require lumbar drain placement. Patients will be randomized to~     either receive inhalation anesthesia with isoflurane or intravenous anesthesia with~     propofol.~      CSF and blood samples will each be collected at the induction of anesthesia, and then again~     ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and~     other Alzheimer's disease-associated markers; blood samples will be assayed for serum~     inflammatory markers and used for genotyping studies. These studies should clarify the~     effect of common anesthetic agents on Alzheimer's disease related neural markers.~   "
108179|NCT01640262|"~     Clinical staging of prostate cancer in Denmark is determined solely by digital rectal~     examination and sometimes by TRUS, even though the investigators know these examinations are~     inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer~     will die with their disease and not of their disease, and the different treatment-options~     may imply greater side effects, it is important to improve the diagnostic localization and~     staging of the tumour for optimal clinical management and therapy selection.~      The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new~     possibilities and approaches in detection, localization and staging of prostate cancer due~     to its high resolution and soft-tissue contrast. mMRI can provide information about the~     morphological, metabolic and cellular changes and characterize tissue- and tumour-~     vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a~     possible tumour and to guide targeted-biopsies towards disease-suspicious areas.~     Internationally published data support the rapidly growing use of multiparametric MRI, as~     being the most sensitive and specific imaging tool for prostate cancer patients.~      While mMRI internationally is a well recognized and accepted method for detection,~     localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in~     Denmark has never been applied. Therefore, this project is carried out in order to evaluate~     the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.~   "
108180|NCT01640249|"~     The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it~     causes any side effects. The study will also measure how much of the study drug gets into~     the blood stream and how long it takes the body to get rid of the study drug. The study drug~     will be given in the morning or evening with or without a meal.~      This is the first time that this study drug is being given to humans. This study is for~     research purposes only and is not intended to treat any medical condition.~   "
108181|NCT01640236|"~     This is a longitudinal Feasibility Study of a novel non-invasive device in assessing~     radiation dose exposure in humans. All patients receiving whole body irradiation therapy and~     meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements~     and slit-lamp examinations on up to eleven occasions starting prior to the first fractional~     dose of irradiation.~   "
108182|NCT01640223|"~     The aim this study is the acquisition and management of a data base for the development of~     the glycaemic regulation algorithms. This database will integrate the measures of blood~     glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of~     insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This~     database will also contain the bolus of insulin injected at meals and the content of meals,~     the reduction insulin level during physical activity and the quantification of this physical~     activity. A study will also be conducted to compare the pharmacokinetics of a bolus of~     insulin identical with the JewelPUMP either the usual pump of the patient.~   "
108183|NCT01640210|"~     The main objective of the study is to verify the reliability of the solutes volumes issued~     by the Debiotech JewelPUMPTM controlled by its remote.~      Three clinical sites are participating in this study:~        -  CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume~          CHARPENTIER, Dr. Sylvia FRANC~        -  Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases,~          Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU~        -  CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor~          Alfred PENFORNIS, Dr. Annie CLERGEOT~      The study will be conducted in 20 patients with type 1 diabetes treated by external insulin~     pump. Patients will be informed of the study during a screening visit. After signing the~     informed consent, they will return to the center where they will wear a JewelPUMPTM~     containing saline water, they will use their pumps in parallel. The investigator or nurse~     education will form the operation of the JewelPUMPTM and they will be instructed to~     replicate the same settings between their usual and JewelPUMPTM pump. The patient will be~     asked to complete visual analog scales of satisfaction with their usual treatment and the~     various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a~     precision balance to have a form of a base for comparison.~      Patients will leave home for a period of about three days, but they will have to come back~     every days to the center. They will be asked to collect all events arising (programming~     problems to deliver a bolus, hardware failure ...) in a booklet.~      At the end of study visit, patients will return to the center where the volumes will be~     assessed by the perfused weighed the various components and devices where they will complete~     the visual analog scales of satisfaction at endpoint.~   "
108184|NCT01640197|"~     The effects of chronic resveratrol supplementation have yet to be investigated in healthy~     humans. It is hypothesised that the effects will be different to those seen in acute~     supplementation. This study will look specifically at cognitive performance, cerebral blood~     flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It~     is hypothesized that these measures will be affected differently by acute and chronic~     supplementation.~   "
108185|NCT01640184|"~     It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney~     disease (CKD) patients who had not succeeded medical therapy and could not get~     parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable~     alternative treatment that help control secondary hyperparathyroidism in CKD patients~     presenting with enlarged parathyroid gland(s) visible at ultrasonography.~   "
108186|NCT01640171|"~     Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related~     macular degeneration, retinal vein occlusion, and diabetic macular edema are being~     administered in the United States at increasing rates. A 2010 study showed that in Canada~     and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000~     citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal~     injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the~     four doctors in my retina group administered a total of 6,494 intravitreal injections; in~     2010, we administered 5021 intravitreal injections.~      Even though intravitreal injections are commonly administered, the optimal method of~     anesthetizing the eye prior to injection has yet to be determined. Some physicians use an~     anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use~     subconjunctival injected anesthetic.~      In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the~     American Society of Retina Specialists (the largest retina society in the world) asked about~     anesthetic methods for administering intravitreal injections, the following response was~     given by the 433 respondents:~        -  Topical anesthetic drop: 21.48%~        -  Topical viscous anesthetic: 23.33%~        -  Topical anesthetic & soaked cotton-tip or pledget: 29.79%~        -  Subconjunctival injection of anesthetic: 24.02%~        -  Other: 1.39%~      An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing~     optimal anesthetic prior to intravitreal injections. (Prenner 2011).~   "
108187|NCT01640158|"~     The primary objective of this study is to evaluate the effects of plasticity-based, adaptive~     cognitive remediation on the cognitive abilities, functional status and quality of life of~     soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a~     mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as~     compared to a computer-based control.~   "
108188|NCT01640145|"~     Maintenance of skeletal muscle mass is crucial during lifespan to retain health and~     functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known~     phenomenon in the elderly and a major challenge viewed from an individual, and a~     socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be~     markedly affected by physical activity and nutritional interventions even at old age.~     Recently, a study in young individuals showed that an acute bout of easily tolerated low~     intensity exercise can prolong the muscle building effects of a milk protein intake compared~     to a non-exercised situation. Therefore, the major aim of the present project is to~     evaluate, whether a low intensity exercise regime in conjunction with milk protein~     supplementation can induce positive adaptations on parameters related to muscle size and~     function in elderly.~      The study focuses on the acute muscle protein synthesis response to low intensity exercise~     and protein supplementation measured with stable isotope tracer techniques. It is~     hypothesized that light muscle activity can augment and prolong the effects of protein~     feeding.~      If a light resistance exercise protocol as investigated in the present project can prove~     beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge~     sarcopenia in a new and tolerable way.~   "
108189|NCT01640119|"~     The investigators want to evaluate whether an original action based on the administration of~     alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce~     mortality due to cardiovascular events.~      Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and~     controlled study.~      The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b~     (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called~     Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other~     364 patients will included in the Usual Treatment Group (no-Bic).~      Results: The aim of the Research Protocol is to demonstrate if that the optimal correction~     of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing~     agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.~      Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal~     Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study~     to evaluate the effects of correction of acidosis on the progression of the kidney disease~     considered as renal death in End-Stage Renal Disease (ESRD) patients.~   "
108190|NCT01640106|"~     The primary objective of this study is to obtain preliminary (pilot) data regarding the~     feasibility of using dietary omega-3 supplementation in children with significant delays in~     language skills; a related secondary objective is to compare adherence to a dosage schedule~     of two easy-to-take formulations. A tertiary objective of this study is to collect~     preliminary (pilot) data pre- and post-supplementation to identify potential improvement of~     skills in a specific area of language development.~   "
108191|NCT01640093|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet~     formulations compared with the current commercial abiraterone acetate tablet formulation in~     healthy male participants, under fasted conditions, at a single dose of 1000 mg.~   "
108192|NCT01640080|"~     The purpose of this study is to assess the efficacy of esketamine compared with placebo in~     improving symptoms of depression in patients with treatment resistant depression.~   "
108193|NCT01640067|"~     Primary aim of the trial~        1. to verify safety and tolerability of expanded human fetal neural stem cells~        2. to verify safety and tolerability of a microsurgery human fetal neural stem cells~          transplantation model~        3. to recognize each change in patient's quality of life~      Secondary aim of the trial~        1. assessment of the impact of human neural stem cells transplantation on the disability~          of ALS in a clinically significant and measurable way~        2. Assessment of the impact of human neural stem cells transplantation on mortality (all~          causes)~   "
108194|NCT01640054|"~     The purpose of this study is to evaluate the long term safety and tolerability of~     fostamatinib in patients in Asia with rheumatoid arthritis (RA).~   "
108195|NCT01640041|"~     The purpose of this study is to test an innovative, advanced FNS microstimulator technology~     developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency~     Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of~     functional gait components in a manner at least as efficacious as current investigational~     FNS systems. The design features of the RFM Gait System are intended to address the problems~     with the current FNS systems. The RFM implant devices are small enough to be inserted using~     only a 5 mm incision[3]. Because both the electrode (anode and cathode) are contained within~     the microstimulator, there are no lead wires traversing the skin, joints, or torso/limb~     junctures. Individual RFMs can be inserted at the motor points and nerves of each of the~     paretic muscles in the involved limb and coordinated using radio frequency technology.~   "
108196|NCT01640028|"~     The purpose of this study is to analyze the relationship between sebum excretion rate and~     the following factors:~        -  Hormone levels (testosterone, dehydroepiandrosterone sulfate)~        -  Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a~          hormone (testosterone) into another one that strongly stimulates sebum production)~        -  Diet~        -  Sun and ultraviolet light exposure.~        -  Facial washing routine~        -  Sleep patterns (time when you start sleeping and total sleep time)~      This study will analyze the relationship between sebum excretion rate and the various~     factors that may influence it in approximately 40 subjects. It will be conducted in one~     center located in Montreal. All devices are known and have already been used in the past.~   "
108197|NCT01640015|"~     The primary purpose of this study is to identify the effect of meal frequency on blood~     pressure (BP) levels of individuals.~   "
108198|NCT01640002|"~     It's a double blind, placebo controlled study to assess the efficacy of Propantheline~     Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.~      We think that the treatment of the OAB with Propantheline could reduce nocturia and~     frequency in sixty percent.~   "
108199|NCT01639989|"~     In this study we will try to show that performing Doppler of the Spiral arteries is doable.~     No outcome will be followed at this stage~   "
108200|NCT01639976|"~     Testing the whether Doppler studies after cytotec treatment can predict success of~     treatment.~   "
108201|NCT01639950|"~     Background:~      - Assessing pain levels is important to improve treatments for different illnesses. Most~     pain rating scales are used to determine pain levels in adults. Pain is also a common~     symptom among children who have cancer. Those who have genetic conditions that may lead to~     cancer may also have pain symptoms. However, the pain scales used for adults have not been~     fully tested in children and young adults. As a result, they may not be as accurate.~     Researchers want to test pain rating scales in children and young adults who have cancer and~     genetic conditions that can lead to cancer.~      Objectives:~      - To study the effectiveness of pain rating scales given to children and young adults with~     cancer and related genetic conditions.~      Eligibility:~        -  Children, adolescents, and young adults between 6 and 25 years of age who have cancer~          or other genetic conditions that can lead to cancer.~        -  Parents of participating children will also be eligible.~      Design:~        -  Participants with cancer or related genetic conditions will fill out four~          questionnaires. These questionnaires will ask about pain levels and how much pain~          interferes with daily life.~        -  Parents will fill out two questionnaires about their child s pain levels and how much~          pain interferes with the child s life.~        -  Pain treatments will not be provided as part of this study.~   "
108202|NCT01639937|"~     Background:~      - People with congenital heart disease may develop heart failure earlier that those who do~     not have the disease. One theory to explain this is that the heart s own blood supply may be~     different in people with congenital heart disease. Problems with this blood supply can~     severely damage the heart. This damage can be studied with a heart imaging test called a~     cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to~     look at the blood supply to the heart in people with congenital heart disease.~      Objectives:~      - To learn more about the blood supply to the heart in people with congenital heart disease.~      Eligibility:~      - Individuals at least 18 years of age who have heart defects caused by congenital heart~     disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have a cardiac MRI scan to look at the blood flow to the heart.~        -  Participants will also have a heart stress test to measure heart function during~          exercise.~        -  Other imaging studies of the heart may be performed to collect more information on~          heart function.~   "
108203|NCT01639924|"~     Background:~      - Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There~     are many different kinds of these diseases. Clinical trials are being developed to study new~     ways to treat them. People who are interested in clinical trials need to be screened before~     they can take part in the studies. Researchers want to evaluate people with different~     stomach and intestine disorders to see if they are eligible for clinical trials.~      Objectives:~      - To study people who have gastrointestinal disorders and see if they are eligible for~     clinical trials.~      Eligibility:~      - Individuals at least 18 years of age who have or may have a gastrointestinal disorder.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood, urine,~          and stool samples will be collected. Imaging studies such as x-rays and ultrasound will~          check to see if the disorder has affected other organs.~        -  Participants may have tests as needed depending on their disorder. These tests include~          the following:~        -  Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.~        -  Stomach acid analysis to look at stomach pH levels.~        -  Wireless capsule endoscopy to take pictures of the small intestine.~        -  Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.~        -  Sitz Marker Study to see how fast stool moves through the colon.~        -  Participants may donate extra blood, urine, or stool samples for study. They may also~          donate stomach contents or tissue from the gut.~        -  Treatment will not be provided as part of this study. However, participants may be~          admitted to other clinical trials.~   "
108204|NCT01639911|"~     This phase I dose escalation study will evaluate alisertib, an Aurora A kinase inhibitor,~     when given in combination with the selective vascular endothelial growth factor receptor~     (VEGFR) inhibitor pazopanib in patients with advanced, previously treated non-hematologic~     solid tumors.~   "
108205|NCT01639898|"~     POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of~     plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical~     signs. Lenalidomide appears to be particularly efficient in this pathology.~      The investigators propose a phase II multicentre protocol, based on the use of lenalidomide~     combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or~     resistant or in relapse.~      Patients who can be treated by local radiation or intensive treatment with stem cell support~     will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before~     radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the~     Len-Dex combination (Group 2).~      A biological study is coupled with this clinical protocol in order to define the best~     biological markers predicting clinical responses, to better understand the POEMS~     pathophysiological mechanisms and to set up a bank of samples which can be used to study~     this rare pathology.~   "
108206|NCT01639885|"~     This study investigates the feasibility and immunogenicity of the triple combination of~     gemcitabine, Peg-Intron and p53 SLP vaccination in patients with platinum-resistant ovarian~     cancer.~   "
108207|NCT01639872|"~     Many individuals with schizophrenia also suffer from marijuana addiction that worsens their~     problems related to schizophrenia. Most of the medications prescribed for schizophrenia have~     no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical~     antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not~     commonly used due to its side effects and is reserved for people who do not respond to other~     antipsychotic medications.~      In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a~     cannabis use disorder will be randomized to a 12-week treatment course with either clozapine~     or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis~     that patient treated with clozapine will have decreased cannabis use as compared to patients~     treated with risperidone.~      Should this study indicate that clozapine will lessen marijuana use in persons diagnosed~     with schizophrenia more than risperidone, it will provide evidence needed to begin to shift~     clinical practice toward its use in this population.~   "
108208|NCT01639859|"~     The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous~     tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images~     obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are~     compared to whole-mount histology.~   "
108209|NCT01639846|"~     To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic~     solution in alleviating the signs and symptoms of allergic conjunctivitis~   "
108210|NCT01639833|"~     The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic~     Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in~     subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve~     replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair,~     etc.), or CABG.~   "
108211|NCT01639820|"~     Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic~     lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the~     classical surgical treatment including identification of the sentinel nodes, full pelvic~     lymph-node dissection and radical hysterectomy.~      The experimental arm is only sentinel node identification + radical hysterectomy.~   "
108212|NCT01639807|"~     The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical~     medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on~     intraocular pressure reduction, treatment side effects, quality of life measures and costs~     in South Indian Population.~   "
108213|NCT01639794|"~     This is an observational study which will look at the improvement in Lower Urinary Tract~     Symptoms (LUTS) in Irish men being treated with Vesitirim™ (solifenacin).~      Vesitirim™ is a competitive specific muscarinic receptor antagonist and has been used~     extensively for the treatment of OAB (Over Active Bladder) in women and has shown~     significant impact on urgency, frequency and incontinence in females. It is also indicated~     for the symptomatic treatment of urgency incontinence and/or increased urinary frequency and~     urgency in men. The purpose of this study is to evaluate LUTS storage symptom improvement in~     men with non neurogenic LUTS who have been prescribed Vesitirim™.~      The effect of Vesitirim (solifenacin) treatment on bothersome symptoms improvement will be~     measured using Over Active Bladder-q Short Form (OAB-qSF) and the Perception of Treatment~     Satisfaction (TS-VAS). The study will also help define some of the characteristics of the~     male population in Ireland who are treated with Vesitirim™ (solifenacin) as well as~     evaluating the effect of Vesitirim™ monotherapy or combination therapy on storage symptoms~     improvement (urgency, frequency and urge incontinence) using a bladder diary and IPSS~     (International Prostate Symptom Score). The study will also evaluate the effect of~     Vesitirim™ monotherapy or combination therapy on nocturia using IPSS. The impact of LUTS on~     quality of life will also be assessed. Data will also be collected regarding adverse drug~     reactions.~   "
108214|NCT01639781|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. Aging is the major~     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial~     function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols~     can counteract age-dependent vascular changes by interacting with key mechanisms, most~     prominently endothelial function.~   "
108215|NCT01639768|"~     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based~     on reduction of upper airways reactivity after 5 months of treatment with different dosages~     of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be~     assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch~     compared to placebo.~   "
108216|NCT01639755|"~     The purpose of this study is to obtain clinical experience with the use of new texture,~     shaped breast implants in bilateral primary breast augmentation.~   "
108217|NCT01639742|"~     The purpose of this study is to obtain clinical experience with the use of new texture,~     round breast implants in bilateral primary breast augmentation.~   "
108219|NCT01639716|"~     The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So~     that the investigators decided to study of cytokines related to T helper 2 pathways. It is~     well known that parasites and allergic situations also use T helper 2 pathways. Because that~     the investigators excluded the patients have parasites and allergic situations. All the~     patients were over 18. The investigators included the patients with non Hodgkin lymphoma~     which new diagnosed. It is observational study. The investigators took blood before~     chemotherapy and four months later. The investigators did not interfere with which~     chemotherapy will be given to patients. This decision was belong to hematologist or~     oncologist who will treat the patient.~   "
108220|NCT01639703|"~     The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT~     perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC)~     and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the~     aim to cover the entire liver.~   "
108221|NCT01639690|"~     The patient has inherited ß-thalassemia major through the genes. These genes have mistakes~     in them, so the body cannot make normal red blood cells. Stem cells are made in the bone~     marrow. They are the earliest form of blood cells.~      This study is being done to see if the investigators can make the stem cells produce normal~     red blood cells and hemoglobin. The investigators do this by collecting the stem cells. The~     genes with mistakes are removed from the cells. These cells are then treated so they have~     the corrected gene for making normal hemoglobin. These treated cells are given back to the~     patient through an injection (shot) in the vein. This is also known as gene transfer. In~     order for the body to accept these cells, the patient will need to receive a low dose of a~     drug called busulfan. It is a drug that will prepare the body to receive the new stem cells.~      This study will let the investigators know:~        -  If it is safe to give the patient the treated stem cells~        -  If the treated stem cells will go into the bone marrow without causing side effects.~      Gene transfer has been used for the past five years. It has been successful in treating many~     blood disorders. At least 20 patients have received the type of treatment that the patient~     will get on this study. This treatment for B-thalassemia major was developed here at~     Memorial Sloan Kettering (MSK). It was studied for a long time in the lab before being given~     to patients.~   "
108222|NCT01639677|"~     This is a randomized clinical trial assessing the outcome of two surgical strategies to~     treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is~     weight loss and weight loss maintenance but other factors as body composition, eating~     pattern, metabolic normalisation, energy expenditure will also be assessed.~   "
108223|NCT01639664|"~     The study objective is to clarify whether the application of high doses CPFA (coupled~     plasma-filtration adsorption) in addition to the current clinical practice is able to reduce~     hospital mortality in septic shock patients in intensive care unit (ICU).~   "
108224|NCT01639651|"~     For many years researchers have been documented that the shoulder of the throwing athlete~     acquires a increase in external rotation of the dominant limb compared to the contralateral~     side.This fact is followed with a loss of the internal rotation of the shoulder, which is~     related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal~     Rotation Deficit (GIRD).~      Among the approaches for this condition the literature is inconclusive due to the low~     methodological quality of clinical trials made,however, the manual therapy has been used~     with success to relief the pain and restore the range of motion.~      The purpose of this study is to analyse the effectiveness of a mobilization with movement~     technique to improve the internal rotation of the shoulder in throwing athletes with GIRD.~      It will be a randomized controlled trial with the CONSORT bases with 40 participants that~     will be divided into two groups:~        -  Control group that will be submitted for an evaluation of shoulder range of motion~          (internal/external rotation)of both limbs, upper limb active movements to warm-up (five~          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds)~          and revaluation immediately post-intervention and four weeks post-intervention.~        -  Mobilization group that will be submitted for an evaluation of shoulder range of motion~          (internal/external rotation)of both limbs, upper limb active movements to warm-up(five~          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds)~          plus a mobilization with movement technique to improve internal rotation of the~          dominant shoulder (three sets of 10 repetitions)and revaluation immediately~          post-intervention and four weeks post-intervention.~      To evaluate the range of movement it will be use a standard goniometer with an attached~     customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to~     the ground.~      The investigators hypothesis is that both group will have improvements in the internal~     rotation of the dominant shoulder, however, the mobilization group will have a statistically~     significant difference compared to control group immediately post-intervention. Four weeks~     post-intervention this difference will equalize, because of the only intervention applied.~      Results will be expressed as hazard ratios (HR) with their respective confidence intervals~     at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0~   "
108225|NCT01639638|"~     Treatment is considered successful if the difference in the response in the reduction of the~     affected area is above 30% for any of the doses compared to placebo Patients will be~     randomised to 1 of 3 treatment arms~        1. Placebo~        2. CIGB-300 - 5 mg~        3. CIGB-300 - 15 mg~      A two week screening visit will take place to assess patient eligibility, at least 2 to 5~     target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients~     included in the study will be randomly assigned to one of three study arms. Treatment~     consists of 3 perilesional applications at the base of the target lesion every 48 hours with~     a window of ±24hs.~      After each application the potential local and systemic adverse events will be identified~     and monitored.~      After the last application is made, weekly clinical evaluations for 3 weeks and then every~     two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will~     be carried out that will define the response to treatment.~      After this visit, patients will be followed every 3 months until one year after the last~     treatment has been completed to confirm response and long-term security of the CIGB-300~     application.~      At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies~     will be conducted to assess the safety from the systemic point of view.~   "
108226|NCT01639625|"~     They include patients who are candidates to complete concurrent treatment with endocavitary~     brachytherapy External radiation therapy + more QT based weekly cisplatin.~   "
108239|NCT01639456|"~     This is a phase II trial designed to test the safety and efficacy (disease free survival~     [DFS]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute~     myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients~     60 years and older who are in a first complete remission after 1 or 2 courses of standard~     AML induction. After a preparative regimen of cyclophosphamide and fludarabine, patients~     will receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed~     by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.~   "
108401|NCT01637350|"~     Different digestive tract reconstruction will affect the blood glucose level of gastric~     cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total~     gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which~     includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C~     -peptide and body weight of gastric cancer patients with type 2 diabetes.~   "
108227|NCT01639612|"~     1. Purpose of the Study - This protocol aims to demonstrate the feasibility and safety of~     autologous ALD-451 cells administered intravenously in World Health Organization (WHO) grade~     IV malignant glioma patients following surgery, radiation therapy and temozolomide; as well~     as to obtain an initial description of the effects of ALD-451 cells on neuro-cognition~     allowing the design of a subsequent phase 2 trial of this intervention in patients with~     malignant glioma. The primary objective of this study is to demonstrate the safety of~     intravenously administered autologous bone marrow derived ALD-451 cells in the brain~     following surgery, radiation therapy and temozolomide in patients with WHO grade IV~     malignant glioma. The secondary objective of this study is to determine the recovery of~     ALD-451 from bone marrow of patients following radiation therapy and temozolomide. The~     exploratory objective of this study is to determine if intravenous administration of~     autologous ALD-451 cells following surgery, radiation therapy and temozolomide in WHO grade~     IV malignant glioma patients may have an effect on subsequent deterioration of~     neurocognition and patient-reported outcomes.~   "
108228|NCT01639599|"~     Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and~     vomiting (PONV). However, precise dose-response studies have not been completed, especially~     in patients at high risk for PONV who require combination therapy. This study sought to~     identify the optimal dose of haloperidol that could be combined with dexamethasone without~     adverse effects in high-risk PONV patients receiving intravenous patient-controlled~     anesthesia (IV PCA) after gynecological laparoscopic surgery.~   "
108229|NCT01639586|"~     One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to~     helping families. It's also of major to involve the patient in the most active treatment~     possible, encouraging social inter relationship as well as cognitive and behavioural~     stimulation activities.~      In the frame of non drug related approaches to Alzheimer disease (AD), several research~     projects and actions have already been conducted, but no specific study concerning the~     efficiency of different types of respite care structures have been conducted so far in~     France. The present project concerns the thematic of the frame Development and~     diversification of respite care structures.~      A platform is defined in the Alzheimer Plan as a diversified range of despite structures~     according to patients' needs and informal caregivers' expectations providing several~     objectives:~      Two objectives targeting the informal caregivers:~        -  offer spare time or tutored~        -  inform, support and accompany~      Two objectives targeting the patients:~        -  encourage maintain of the patient social life and relationships and work together~          towards his/her psychological and emotional well-being~        -  contribute to improve functional cognitive and sensory capacities~      The study COMPARSE suggests to compare for the patient - informal caregiver couple, the~     impact of three different groups of patient care on health profit; resit platform (P), the~     day care group (D), the control group without access to a respite structure (C).~   "
108230|NCT01639573|"~     This phase I/II pilot trial seeks to demonstrate that prolonged administration of Campath-1H~     without prior marrow or stem cell harvesting can result in immunoablation similar to that~     achieved by hematopoietic stem cell transplantation (HSCT) from either bone marrow or~     peripheral blood stem cell sources in children and adolescents with severe treatment~     refractory systemic sclerosis (SSc).~   "
108231|NCT01639560|"~     The purpose of this study is to determine if varenicline is effective in treating tobacco~     dependence in adults who smoke 5-10 cigarettes per day.~   "
108232|NCT01639547|"~     The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD)~     plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the~     clearance of HCV viremia 24 weeks after treatment end~   "
108233|NCT01639534|"~     The purpose of the study is to determine if a new blood test can help the doctor determine~     if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the~     brain. In this study the investigators are analyzing your blood for a new test that might~     help doctors decide if symptoms are from a neurologic problem.~   "
108234|NCT01639521|"~     This study is about two chemotherapy study drug combinations (regimens) that are used for~     urothelial (bladder or upper urinary tract) cancer. Both study drug regimens, gemcitabine~     (gemcitabine hydrochloride) plus cisplatin, and high-dose-intensity MVAC (methotrexate,~     vinblastine, doxorubicin plus cisplatin), are standard chemotherapy regimens. Both regimens~     are used to treat people with urothelial cancer that has spread to other organs. Both study~     drug regimens have been proven to be effective in lowering the risk of the cancer coming~     back, but it is not known which regimen is the best. This study hopes to learn whether there~     is a difference in the effectiveness and side effects of these two study drug regimens when~     they are given to people who have had their urothelial cancer completely removed.~   "
108235|NCT01639508|"~     The purpose of this phase II study is to find out what effects cabozantinib (XL184) has,~     good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or~     NTRK fusion, or increased MET or AXL activity.~      A phase II study looks at how effective a medication is at treating a specific type of~     cancer and collects information on the side effects of the study treatment.~      RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell~     growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In~     addition, this drug interferes with other cell pathways that also cause cancer cells to~     grow, form new blood vessels, and spread to other organs of the body. The goal of using~     cabozantinib is to shrink the cancer and to prevent it from growing~      Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as~     medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects~     it causes and can anticipate them.~   "
108236|NCT01639495|"~     This is a prospective, multicenter, non-randomized continued access clinical evaluation~     utilizing the THERMOCOOL® SMARTTOUCH™ catheter.~   "
108237|NCT01639482|"~     Regional metabolic changes associated with response to 6 weeks of citalopram treatment,~     using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG~     PET). The following hypothesis will be tested: Antidepressant response or remission in~     depressed BPD patients will be associated with changes in cortical (prefrontal, parietal,~     premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior~     cingulate, and anterior insula) regions, consistent with SRI antidepressant response in~     unipolar depressed patients.~   "
108240|NCT01639443|"~     In this research study, investigators use colonoscopy as a case example to evaluate a~     predictive overbooking model derived using patient-level predictors of absenteeism. The~     no-show overbooking intervention employs a logistic regression model that uses patient data~     to predict the odds of no-showing with 80% accuracy. These projected no-show appointments~     will be overbooked by clerks for patients who agree to join a fast track short-call line.~     By rapidly processing endoscopy patients and moving them out of traditional slots,~     investigators predict more scheduling slots would become available for patients awaiting~     colonoscopy.~   "
108241|NCT01639430|"~     Retrospective analysis of a quality measurement project examining the quality of vital~     parameter measurement in consecutive patients >= 75 years presenting to the emergency~     department.~      Primary goal of the study is to evaluate the diagnostic accuracy of body temperature~     measurement using different methods to diagnose infection in patients >= 75 years presenting~     to the emergency department. The secondary goal is to compare the reliability of tympanal~     and temporal artery thermometry with rectal temperature measurement.~   "
108242|NCT01639417|"~     The purpose of this study is to better understand why some women with breast cancer develop~     chronic pain.~   "
108243|NCT01639404|"~     This study aims to evaluate the efficacy of umbilical cord blood therapy for children with~     cerebral palsy.~   "
108244|NCT01639391|"~     Patients with ALS will be included in the reference center for ALS in hospital La Pitié~     Salpêtrière, Paris.~      The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank~     for studying molecular, cellular and genetic parameters of the pathology.~      iPS (induced pluripotent stem cells) and then differentiated cells will be generated.~      The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS,~     differentiated cells).~   "
108245|NCT01639378|"~     The REACH study, is a prospective, double-blinded, randomised, controlled study of the~     safety and effectiveness of renal denervation in subjects with chronic systolic heart~     failure. Bilateral denervation will be performed using the Symplicity Catheter - a~     percutaneous system that delivers radio frequency (RF) energy through the luminal surface of~     the renal artery.~   "
108246|NCT01639365|"~     The pressure exerted by the ablation catheter on the tissue has been shown to play an~     important role on determining the size and the potential efficacy of the ablation lesions. A~     direct information on the force exerted by the catheter tip obtained from the SmartTouch~     technology might improve the assessment of the scar areas during electroanatomical mapping~     in patients with ventricular tachycardia (VT) due to ischemic disease or cardiomyopathy. The~     objectives of the study are to compare the areas of scar (defined as a low-voltage~     threshold) obtained from the conventional voltage map with those obtained after the contact~     map information is available to the operator and to determine if the availability of the~     contact information allows an improvement of the electroanatomic map by correcting the~     points taken in no-contact areas. Twenty to 30 consecutive patients with ventricular~     arrhythmias due to ischemic heart disease or dilated cardiomyopathy undergoing VT ablation~     will be included in a prospective, one-center, non-randomized study. A voltage map of the~     left ventricle will be obtained using the CARTO-3 navigation system and the scar areas as~     well as the areas of potential interest for ablation will be delineated in the standard way~     and saved as the control map. The force information will be recorded by the system but will~     not be available to the operator until the control map is saved. Following this step the~     contact map will be available to the operator to be compared with the control map and~     further mapping and point acquisition will be allowed to correct the areas previously~     acquired with poor or no contact. The final map after corrections have been made will be~     saved as the corrected map. The ablation procedure will then be performed as usual. Both~     maps will be compared in a deferred way to know how are classified the areas without contact~     when no pressure information is available, and how many non-contact points are falsely~     assumed to be low-voltage or dense scar points. These comparisons will give information on~     how much the standard electroanatomic map can be improved when the force information is~     added.~   "
108247|NCT01639352|"~     The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin~     receptors which make them sensitive to the inhibitory effects of a new somatostatin analog,~     SOM230. This analog has greater and broader binding affinity to somatostatin receptors~     compared to the current drug in use, sandostatin LAR. Thus, SOM230 has the potential to be~     more effective in the treatment of patients with hepatocellular carcinoma.~   "
108248|NCT01639339|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab~     in adult patients with active lupus nephritis.~   "
108249|NCT01639326|"~     This study aims to use the corresponding pharmacogenetic analysis to increase the dose of~     irinotecan in the schemes commonly used standard chemotherapy in advanced colorectal cancer~     treatment first. The project aims to improve the therapeutic index of chemotherapy. This~     optimization is raised based on the administration of different doses of the drug depending~     on the genotype UGT1A1 gene. The research team proposes this project to demonstrate how the~     administration of high doses of irinotecan in the FOLFIRI scheme in patients with genotype~     UGT1A1 favorable (wild homozygous * 1 / * 1 and heterozygous * 1 / * 28), significantly~     improves the efficiency of the antineoplastic agent without significant increase in~     toxicity. Secondarily will assess the possible prognostic factors related to tolerance and~     efficacy.~      The primary objective is to evaluate the efficacy of high doses of irinotecan in the FOLFIRI~     scheme in patients with metastatic colorectal cancer with a favorable genotype UGT1A1 (wild~     homozygous * 1 / * 1 and heterozygous * 1 / * 28).~   "
108250|NCT01639313|"~     A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its~     determination has been difficult using the standard approaches. The aim of the study is to~     evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac~     magnetic resonance imaging (CMR).~   "
108251|NCT01639300|"~     The purpose of this study is to assess the safety and tolerability of single ascending~     doses, as well as of repeated administrations of GNbAC1 in MS patients.~      Scientific research has shown that the expression of genes of a virus which is integrated in~     the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a~     critical role in the causation of multiple sclerosis.~      GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV~     that might contribute to the development or deterioration of multiple sclerosis.~   "
108252|NCT01639287|"~     There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically~     painless synovitis in the hands.~      The objective of this study is to compare painless synovitis with painful synovitis~     according to the sonographic (Gray-scale and power Doppler) findings.~      A sonographic examination (Gray-scale and power Doppler) will be done to evaluate~     metacarpophalangeal joints of patients without local painful and will be a comparison with~     patients with local painful.~   "
108402|NCT01637337|"~     To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in~     patients with >3cm renal pelvis stone.~   "
112840|NCT01579188|"~     The purpose of this study is to evaluate survival in inoperable stage III Non-small Cell~     Lung Cancer patients following chemo-radiotherapy followed by GV1001 vaccination plus best~     supportive care.~   "
108253|NCT01639274|"~     Highly active antiretroviral therapy (HAART) has considerably improved survival of~     HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have~     largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic,~     neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to~     immunodepression. All this comorbidities are more reported in HIV-infected patients than in~     general non-HIV infected patients. Those are directly linked to the effect of chronic~     HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this~     population.~      Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial~     chronic infection, immunity, and ageing are also involved in the physiopathology of COPD.~     This disease has never been evaluated in a large prospective cohort of HIV-infected patients~     whereas there is a known increase of tobacco consumption and pulmonary infection in this~     population regardless to the general population.~      Characterisation of COPD disease in HIV patients will allow us to make an hypothetic~     epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and~     to study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate~     pulmonary ageing.~   "
108254|NCT01639261|"~     Improvement of quality of life in patients with BO and establishment of a new third line~     therapy~   "
108255|NCT01639248|"~     The purpose of this study is to determine the activity of ENMD-2076 as defined by the~     clinical benefit rate when patients with previously treated locally advanced or metastatic~     triple negative breast cancer are treated with daily oral ENMD-2076.~   "
108256|NCT01639235|"~     This is a study on a population of flight attendants who were exposed to occupational~     secondhand tobacco smoke (SHS). This research will examine associations between flight~     attendant SHS exposure and development of respiratory illnesses, reproductive problems, and~     cardiovascular diseases.~   "
108257|NCT01639222|"~     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a~     newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the~     amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as~     compared to baseline.~   "
108258|NCT01639209|"~     The purpose of this research study is to compare the outcomes of pneumatic retinopexy with~     the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal~     detachment, in terms of anatomical success, functional success and impact on patient quality~     of life.~   "
108259|NCT01639196|"~     The purpose of this study is to explore the effects of writing about chronic pain on mental~     and physical health. The effectiveness of two different types of brief online writing~     interventions will be explored in individuals with chronic pain.~   "
108260|NCT01639183|"~     The purpose of this study is to investigate whether brushing the teeth of nursing home~     residents with a power toothbrush as compared with standard care typically provided in~     nursing homes, will increase caregiver compliance with the provision of daily oral care as~     well as lower oral and systemic inflammation.~   "
108261|NCT01639170|"~     The aim of this study is to evaluate if the presence of abdominal free air on a plain chest~     radiograph predicts gastrointestinal perforation. We aimed to enroll all patients undergoing~     abdominal surgery reporting major symptoms and signs suggestive of gastrointestinal~     perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.~   "
108262|NCT01639157|"~     Cocaine use disorders are an unrelenting public health concern. Intensive research efforts~     have yielded behavioral interventions that reduce cocaine use, however, these interventions~     are not universally effective and treatment effects diminish over time. Development of a~     pharmacotherapy that enhances the efficacy of these interventions is a priority for the~     National Institute on Drug Abuse. This study proposes to determine the impact of buspirone~     maintenance on self-administration of cocaine and alternative reinforcers. These preliminary~     data will be used to support further research developing buspirone as a pharmacotherapy for~     cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects~     of cocaine and increase the reinforcing effects of alternative reinforcers.~   "
108263|NCT01639144|"~     The purpose of this study is to see if applying PRP and PPP to surgical sites and the~     closing incision helps prevent infection and slow wound healing.~   "
108264|NCT01639131|"~     Determine the efficacy of combination Gemcitabine and Docetaxel chemotherapy in the~     treatment of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI)~     phenotype.~   "
108265|NCT01639118|"~     Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with~     abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh~     technology have been developed for the specific indication of small ventral hernias; this~     technique is very attractive because the mesh can be introduced through a nearly invisible~     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the~     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No~     literature is available on the adequate size of mesh needed to repair a hernia defect of an~     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a~     large mesh device. Small hernias might benefit of repair with a small mesh device so no~     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size~     to have more overlap of the mesh beyond the hernia defect.~      With this prospective cohort study the investigators want to explore the efficacy of C-QUR~     V-Patch of different sizes for the different sizes of hernia defects.~   "
108294|NCT01638741|"~     The purpose of this study is to provide new knowledge about:~        -  Integration of rehabilitation in a highly specialized gynaecological department.~        -  Development and testing of an individually adapted rehabilitation process.~        -  Needs for rehabilitation among women with gynaecological cancer.~        -  Connection between adult attachment style for women with gynaecological cancer and~          their quality of life, rehabilitation needs and symptoms of depression /PTSD.~   "
108295|NCT01638728|"~     The investigators compared the depth of the RAE tube [Preformed oral tracheal tubes were~     first described by Ring, Adair and Elwyn (therefore called RAE tubes)] when fixed at the~     midline and at the angle of the mouth, and after fixing the tube at the angle.~   "
108296|NCT01638715|"~     The purpose of this study is to find biological response patterns of patients with~     rheumatoid arthritis to drugs with different biologic modes of action. This study should~     help to predict therapeutic responses and to find the right therapy for the right patient.~   "
108266|NCT01639105|"~     Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an~     important role in patient satisfaction and self-image. Several treatment modalities are~     proposed for scars with variable success.~      Ablative fractional laser treatment is a rather new concept. Many microscopic small laser~     beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser~     beams heat up. This thermal effect stimulates the wound healing and potentially leads to a~     remodeling of the skin structure.~      Ablative fractional laser treatment has been used successfully for treatment of pigment~     changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2~     ablative fractional laser treatment has a positive clinical effect on various types of scars~     however this has not been proven yet in a prospective randomized trial. The low morbidity of~     the treatment and the lack of convincing adapted treatment modalities for various types of~     scars make this treatment attractive.~      That's why the investigators aim with this randomized study to evaluate the clinical effect~     and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars~     due to surgical interventions.~      Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the~     above mentioned scars, three months after the last laser treatment, with a prospective~     randomized intra-patient controlled study.~      Study design Prospective single blinded randomized intra-patient controlled study. The study~     comprises 4 study visits.~      Study population The population consists of one group of patients with scars after recent~     surgical operations. The patients must meet the inclusion and exclusion criteria described~     in the protocol.~      Method The scar will be divided in two equal halves. The two halves will be randomized. One~     part will not be treated. The other part will undergo three times the 10 600 nm ablative~     laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment~     will be evaluated three months after the last treatment with objective and subjective~     parameters.~      Most important study endpoints:~        -  Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be~          done of the treated and untreated parts with the POSAS scar scale, by a study~          collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal~          skin, 10 = worst scar imaginable), before start and twelve weeks after the last~          treatment.~        -  Evaluation of the pain related to the treatment. The pain will be scored by the patient~          with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever).~        -  Evaluation of the side effects of the treatment. A standardized form will be used.~        -  Evaluation of the global patient satisfaction regarding the treatment.~        -  Clinical photos, before start and twelve weeks after the last treatment.~   "
108267|NCT01639092|"~     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil~     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by~     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve~     patients. Until recently, however, many patients commenced antiviral treatment with inferior~     NAs prior to the availability of TDF or ETV, such as lamivudine (LAM) which has a low~     genetic barrier to resistance.~      ETV resistance increase up to 51% of patients after 5 years of ETV treatment in~     lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit~     mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at~     rtT184, rtS202, or rtM250.~      In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are~     little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance.~      On the other hand, there was a retrospective cohort study reporting that, with the~     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6~     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased~     in patients with ADV or ETV-resistance.~      Thus, there is no consistent treatment recommendation for patients with ETV-resistance.~      In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as~     effective as tenofovir plus entecavir in inducing complete virologic response in CHB~     patients with genotypic resistance to ETV and partial virologic response to ongoing~     treatment.~   "
108268|NCT01639079|"~     The primary goal of this project is to carry out a randomized controlled trial (RCT)~     comparing quit rates of a Spanish/English stop smoking Web site to those of a~     no-intervention or quit on your own control. The investigators have not included a~     no-intervention condition in previous Web studies and although 20% of participants quit~     smoking at one year are 20%, obtaining evidence that the investigators interventions yield~     higher abstinence rates than a no-intervention control is the next logical step.~     Furthermore, although the investigators Web site was designed in English and Spanish, the~     investigators success in attracting the U.S. Hispanic/Latino (HL) population in either~     language has been limited, so this project only will only conduct intensive telephone~     follow-up of HL smokers and add new recruitment methods to do so.~   "
108269|NCT01639066|"~     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil~     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by~     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve~     patients. Until recently, however, many patients commenced antiviral treatment with inferior~     NAs prior to the availability of TDF or ETV, such as lamivudine (LAM) or adefovir (ADV)~     which has a low genetic barrier to resistance.~      For patients who developed genotypic resistance against ADV, the efficacy of TDF monotherapy~     is controversial. In recent studies, TDF monotherapy produced significant suppression of HBV~     replication. However, only half of patients with initial ADV resistance achieved an~     undetectable viral load (<15 IU/ml) with 48 weeks of therapy.~      On the other hand, there was a retrospective cohort study reporting that, with the~     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6~     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased~     in patients with ADV or ETV resistance.~      Together, these observations indicate that there is a controversy about the efficacy of TDF~     monotherapy in patients with genotypic resistance to ADV.~      Thus, in this clinical trial, the investigators will clarify whether tenofovir monotherapy~     is effective in inducing complete virologic response compared with tenofovir plus entecavir~     in CHB patients with genotypic resistance to ADV and partial virologic response to ongoing~     treatment.~   "
108270|NCT01639053|"~     This is a ten-year postapproval study to evaluate the long-term clinical performance of~     Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket~     environment.~   "
108271|NCT01639040|"~     The purpose of this study is to assess the safety of REGN668 (SAR231893) administered~     concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic~     dermatitis (AD).~   "
108297|NCT01638702|"~     Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the~     arms, but which pass in the veins to beside the heart. They are associated with occasional~     complications due to infection or blockage of the vein that they are in. The investigators~     want to investigate whether PICCs in the right arm have lower complications than those in~     the left. This difference in complication rates has been noticed in most other forms of~     central venous access.~   "
108298|NCT01638689|"~     Healthy males were examined with positron emission tomography (PET) and the radioligand~     11C-AZ10419369, before and after administration of a single dose escitalopram. A change in~     the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was~     hypothesized to reflect a change in serotonin concentration.~   "
109069|NCT01628614|"~     This is an observational study and will evaluate IOP reduction in newly diagnosed patients~     with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at~     the discretion of the participating physicians according to their clinical judgment and the~     local standard of medical care.~   "
108272|NCT01639027|"~     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a~     perspective of maternal and fetal well-being, and for the providers of the birth services.~     Avoiding along, protracted labor entails shorter exposure to pain, anxiety and stress and~     would thus translate into a major improvement in maternal satisfaction with the childbirth~     experience.~      Based on the premise that shortening the length of labor is beneficial, interventions aimed~     at accelerating the progression of labor have been introduced routinely as part of standard~     labor management and care throughout the 20th century. Certain labor accelerative~     procedures, such as amniotomy, became common practice and have been put to the acid test of~     randomized control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics~     as a method of augmenting labor was ﬁrst described in 1937 by Hirsch, who reported a~     decrease in labor length by two to four hours following Intrapartum administration of an~     atropine-like drug (Syntropan®)mainly among older nulliparas.~      Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts~     specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth~     muscle spasm.~      This inhibitory action is detected only in lower uterine segment during labor since muscle~     fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use~     of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects.~      The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of~     active first stage of labor in nulliparous women as compared to placebo?~   "
108273|NCT01639014|"~     The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine~     reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.~   "
108274|NCT01639001|"~     This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single~     agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in~     First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer~     Patients. The objective of the study is to demonstrate that Crizotinib is superior to~     first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging~     Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC~     whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic~     Lymphoma Kinase) gene locus.~   "
108275|NCT01638988|"~     The results of studies conducted until now does not determine what the best way to treat~     infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This~     study objective is to determine the best treatment for such patients. The long-term~     consequence health of women with PCOS are multiple. The woman with PCOS has a risk of~     developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility.~     The insulin resistance plays an important role in all this medical condition. Clomiphene~     Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and~     anovulatory infertility.~   "
108276|NCT01638975|"~     This study tests a computerized cognitive training program designed for young individuals~     with compulsive hair pulling (also known as trichotillomania;TTM). Research suggests that~     individuals with TTM are characterized by poor cognitive abilities to suppress irrelevant~     response. This ability is called response inhibition. The current study tests a cognitive~     training program designed to improve individuals' cognitive abilities of response inhibition~     through a 8-session computerized training program. The investigators hypothesize that those~     who complete the response inhibition training program will show a greater reduction in hair~     pulling symptoms, compared to those assigned to a waitlist group.~   "
108277|NCT01638962|"~     The purpose of this study is to compare the effects of neuromuscular exercise and analgesic~     use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).~      It is expected that the two groups will receive equipotent pain relieving effect, despite~     this, the investigators expect a between group difference in knee joint load, and the~     exercise group will have a reduction in knee joint load.~   "
108278|NCT01638949|"~     Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight.~     An early diagnosis of AD is urgently needed as it would constitute a determinant~     breakthrough from a social, financial and research standpoints. Therefore, the investigators~     need predictive markers of AD, and neuroimaging is a particularly promising tool, especially~     when using complementary neuroimaging techniques and a longitudinal design, allowing to~     assess the relationships between the different biomarkers of the disease, their dynamic and~     their chronology.~   "
108279|NCT01638936|"~     The purpose of this study is to test safety and anti-tumor activity of BT062 in combination~     with lenalidomide and dexamethasone to define the best doses for treating patients with~     relapsed and refractory multiple myeloma.~   "
108280|NCT01638923|"~     To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and~     dienogest in the treatment of heavy menstrual bleeding~   "
108281|NCT01638910|"~     To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate~     and dienogest in healthy female subjects.~   "
108282|NCT01638897|"~     The purpose of this study is to evaluate long-term performance of the DF4 Connector System.~     This evaluation is based on the number of DF4 lead-related complications occurring during~     the study compared to the number of leads enrolled in the study. The DF4 systems will be~     followed for 5 years after implant. This study is required by FDA as a condition of approval~     of the DF4 Connector Systems. This study is conducted within Medtronic's post-market~     surveillance platform.~   "
108283|NCT01638884|"~     The purpose of this study is to investigate prospective merory (memory of intentions) in~     healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease)~     patients.~   "
108284|NCT01638871|"~     The purpose of this study is to translate a proven pain coping skills intervention for~     osteoarthritis (OA) patients into an engaging and easy-to-use Internet-based intervention~     that uses innovative technologies to mimic traditional, in-person training sessions.~   "
108285|NCT01638858|"~     In this prospective, open-label clinical study is to investigate the behavior of the retinal~     functions during development of diabetic macular disease (DME) under the influence of~     Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is~     used here as an objective criteria to information about the retinal function obtain.~   "
112892|NCT01578512|"~     The purpose of this study is to determine the best format for delivering a brief behavioral~     weight loss intervention to young adults 18-25 years of age.~   "
108286|NCT01638845|"~     INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing~     frequency and its high morbidity and mortality. The leading cause of death is cardiovascular~     decompensation, caused by painful phenomena associated with fracture and orthopedic~     surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in~     mortality but are associated with numerous side effects that prevent routine use. Peripheral~     analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in~     postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months.~     Elderly patients suffering from a hip fracture, no study has investigated the effect of~     local analgesia continuous femoral perineural catheter on the incidence of cardiovascular~     events in the perioperative period.~      OBJECTIVE: The main objective of this work is to show that perineural analgesia block~     continuous local anesthetic reduces the incidence of cardiovascular complications in the~     preoperative period of a patient with a hip fracture and fact, show that this technique~     decreases the incidence of mortality at one year of patients with a hip fracture (secondary~     objective).~      MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It~     compares two populations of patients: one has a perineural analgesia by continuous infusion~     via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other~     only systemic analgesia without development of a catheter perineural (n = 157). The duration~     of patient participation will be 12 months. In the first 24 hours after a hip fracture after~     randomization, study participants will benefit from the installation under strict asepsis, a~     continuous block by catheter, placed by an anesthesiologist experienced control room~     post-interventional. The local analgesia will be provided by continuous administration via~     the perineural catheter, ropivacaine for 5 days for the treated group. Except the local~     analgesia protocol, the protocols pre-and postoperative systemic analgesia and general~     anesthesia will be identical for all participants of the 2 groups, similar to techniques~     proposed in the context of everyday clinical practice, ensuring analgesia optimal for all~     patients in the study. The main features will be found three bioassays Troponin IC and 3~     electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition,~     cardiovascular clinical monitoring and quantification of pain ( will be performed daily for~     8 days after inclusion. Finally, an assessment of higher functions by ladder MMS will be~     conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3~     months and 1 year will be realized.~   "
108287|NCT01638832|"~     This study will evaluate the association of non-alcoholic fatty liver disease and coronary~     artery disease. All patients presenting for coronary angiogram will receive the following~     examination:~        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan~        -  blood examination including biochemical markers The results of non-invasive liver~          steatosis and fibrosis measurement are compared with the results of coronary angiogram~          concerning the presence or absence of coronary artery disease.~   "
108288|NCT01638819|"~     Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in~     patients with autism over six months after infusion as measured by changes in expressive and~     receptive language.~      Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor~     alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin~     1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).~   "
108289|NCT01638806|"~     Patients with acute myocardial infarction (AMI) are categorized according to the~     electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction~     (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3)~     remaining patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).~      Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous~     coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is~     why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers~     with PPCI facilities is recommended.~      In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72~     hours of symptom onset, is associated with improved outcome when compared to late~     angioplasty or conservative therapy. No trials have so far been able to diagnose patients~     with NONSTEMI in the prehospital phase or immediately on arrival at a hospital, and triage~     them directly to PPCI. Implementation of point-of-care (POC) testing of biomarkers may~     enable prehospital or early inhospital establishment of the diagnosis NONSTEMI.~      The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase~     or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c)~     ECG findings and then randomize patients to I) PPCI, or II) medical therapy and~     angiography/angioplasty within 72 hours (todays routine).~      Se below for detailed description~   "
108290|NCT01638793|"~     The present study is a randomized, prospective, single-blinded study. Patients presenting~     for colonoscopy under sedation will be included according to the statistical sample size~     calculation. Patients will be randomized to either group 1- capnographic monitoring or group~     2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia~     are documented and compared in both groups.~   "
108291|NCT01638780|"~     The main objective of the study is to investigate if resveratrol supplementation can improve~     overall and muscle-specific insulin sensitivity in type 2 diabetic patients.~      As a secondary objective the investigators want to investigate whether the improved insulin~     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a~     reduced intrahepatic and cardiac lipid content.~   "
108292|NCT01638767|"~     Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take~     Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in~     order to better control and also plan the onset of the ovary stimulation with gonadotropin.~      Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days.~     Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause~     higher stress level for some users. Presently on the market, there is a ring-shaped~     contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The~     purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing~     is that it can be left in place for a period of up to 35 days without any other manipulation~     and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better~     hormone stability in the blood. Although the side effects and the benefits are comparable~     for the two treatments, some studies have shown that more patients would respect the~     treatment with NuvaRing and that the level of satisfaction would be higher in women using~     NuvaRing when contraception is needed.~      The purpose of the study is to compare the rate of satisfaction as well as the level of~     stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol.~     Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing~     constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro~     Fertilization cycles in long protocol.~   "
108293|NCT01638754|"~     Patients with heart failure and cardiomyopathy that have been referred for Cardiac~     Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided~     treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery~     will significantly advance the field of heart failure therapy.~   "
138492|NCT01242176|"~     The objective of the study is to investigate the relative bioavailability of the final~     tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).~   "
108299|NCT01638676|"~     The main purpose of this study is to evaluate the safety of Vemurafenib in combination with~     Metformin in melanoma patients. The phase II part of the study will also evaluate the~     clinical activity of the combined regiment. Based on pre-clinical studies and a phase I~     trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose~     of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes~     in terms of objective response rates and survival in metastatic melanoma patients.~   "
108300|NCT01638663|"~     The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium~     and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure,~     pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric~     oxide synthesis in healthy subjects.~   "
108301|NCT01638650|"~     This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a~     modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients.~     Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first~     week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second~     week. The study treatment will be given in combination with two Nucleoside Reverse~     Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment~     guidelines. Anticipated time on study treatment is 14 days.~   "
108302|NCT01638637|"~     The objective of this study is to obtain female first-catch urine, vaginal, cervical and~     endocervical swabs and male first-catch urine and urethral swabs for testing with multiple~     APTIMA Assays on the Gen-Probe PANTHER® System~   "
108303|NCT01638624|"~     The release of tourniquet produces reactive oxygen species which can cause injury. Propofol~     is chemically similar to phenol-based free radical scavengers.~      Plasma total antioxidant capacity is a well-established marker of the overall protective~     effect of antioxidants in body fluids.The aim of the study is to investigate the effects of~     propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).~   "
108304|NCT01638611|"~     HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is~     the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown~     signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes,~     repeat dose treatment with HIP results in new islet formation and improvement in blood~     glucose measurements.~      HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.~      The present clinical trial protocol proposes the first administration of HIP2B to humans~     with the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous~     single ascending doses.~   "
108305|NCT01638598|"~     Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after~     single rising doses (SRD) in healthy Asian male volunteers~   "
108306|NCT01638585|"~     In this randomized clinical trial (RCT) the investigators are trying to find out whether a~     low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum~     of 30 days is capable of prolonging the survival time without major amputation.~   "
108307|NCT01638572|"~     Well-regulated glycosylation is essential for the normal development of the nervous system.~     Altered expression of glycosyltransferases with resulting dysregulated glycosylation of~     neuroblastic cells might lead to the development of NB. The~     β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity~     to form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog~     of human B4GALNT3, has been suggested to regulate the neuronal development. By~     immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well~     with histological grade of differentiation in NB tumor samples. Since well differentiated~     tumors usually carry a better prognosis, we thus speculate that expression of B4GALNT3 in~     tumor tissues can a favorable prognostic factor of NB.~      To explore the role of B4GALNT3 in the prognosis of NB, we propose the following project~     with two specific aims:~      Aim Ⅰ: Establishing the significance of B4GALNT3 in the prognosis of NB: We plan to collect~     90 NB tumor samples, and evaluate the RNA and protein expression levels by Q-PCR, Western~     blot, and immunohistochemistry in the tumor samples. The results will be compared with the~     other clinicopathological and biological factors of NB. Also the expression levels of~     B4GALNT3 in tumor tissues will be correlated to the patients' outcome to clarify whether~     B4GALNT3 could be a prognosis marker of NB.~      Aim II: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For~     further strengthening the prognostic role of B4GALNT3 in NB, NB cell phenotype and behavior~     changes after overexpression or knock-down of B4GALNT3 are evaluated by in vitro assays as~     well as by a nude mice xenograft model.~      In summary, if our project can establish the role of B4GALNT3 expression in NB, we may~     further subclassify the NB patients, and give the NB patients more appropriate therapies to~     improve patients' outcome. Furthermore, B4GALNT3 could potentially serves as a therapeutic~     target in the future.~   "
108308|NCT01638559|"~     The primary objective of this study is to assess the efficacy of immunosuppression~     withdrawal (ISW) in pediatric liver transplant (tx) recipients.~   "
108309|NCT01638546|"~     This randomized phase II trial studies how well temozolomide with or without veliparib works~     in treating patients with small cell lung cancer that has returned or does not respond to~     treatment. Temozolomide works by damaging molecules inside the cancer cells, such as~     deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may~     stop the growth of tumor cells by blocking proteins that are needed for repairing the~     damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know~     whether temozolomide is more effective with or without veliparib in treating patients with~     relapsed or refractory small cell lung cancer.~   "
108310|NCT01638533|"~     This phase I trial studies the side effects and best dose of romidepsin in treating patients~     with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction.~     Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking~     the activity of proteins that are important for the cancer's growth and survival.~   "
108311|NCT01638520|"~     New approaches are needed to achieve more rapid elimination of dormant mycobacteria and~     thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant~     mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance~     immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key~     cytokine in the immune response to TB that may impair the clearance of mycobacteria. We~     hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an~     adjunct to standard treatment.~      The aims of this trial are to determine whether administration of pascolizumab as an adjunct~     to standard combination treatment for drug-sensitive TB produces changes in one or more~     parameters of bacterial or host response (including bacterial clearance, host clinical~     status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate~     potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously~     demonstrated in healthy volunteers and patients with asthma) in patients with TB.~   "
108313|NCT01638494|"~     Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The~     investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the~     efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in~     consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 +~     and VitD intake < 70% of dietary reference intakes (DRIs) were invited to participate in~     prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary~     counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a~     commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan,~     Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1)~     serum VitD levels were assessed.~   "
108314|NCT01638481|"~     The purpose of the study is to identify the inflammatory and coagulation pathways and~     mechanisms that are activated immediately following burn injury, and how they affect~     outcomes in terms of organ failure and death. This study also addresses the limitation of~     current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances~     in severely injured patients both in a comprehensive and rapid manner.~   "
108315|NCT01638468|"~     The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety,~     efficacy, adverse events and any new information that may surface regarding the use of the~     AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main~     pulmonary and lobar arteries ≥ 6mm in diameter.~   "
108316|NCT01638455|"~     Characterize Masimo noninvasive technology in spot check reading on subjects and make~     comparison to invasive blood sampling tested on reference analyzers.~   "
108317|NCT01638442|"~     The objectives of this study are to evaluate the safety and tolerability; and to determine~     the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.~   "
108318|NCT01638429|"~     The purpose of this study is to determine how certain types of bacteria in the human gut may~     affect weight gain, and contribute to the development of diabetes.~      The investigators initial studies have shown that gut bacteria that produce methane may~     directly affect weight gain. These bacteria, called methanogens, produce methane gas as a~     byproduct, which can be detected through breath testing. Methane can slow the passage of~     food through the intestines, which would allow extra time for uptake and absorption of~     nutrients and calories, and might contribute to weight gain. The investigators have also~     found that people who have increased levels of methane-producing bacteria in their~     intestines also have higher levels of glucose in their blood. Therefore, control of how the~     body responds to insulin and uses glucose may be altered in methane-producing individuals.~      This research study is designed to test the investigational use of the drugs neomycin and~     rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While~     neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and~     hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the~     toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating~     travelers' diarrhea, they are not yet approved to be used together for the treatment of~     methanogens or obesity.~   "
108319|NCT01638416|"~     In Australia, blood for transfusion has a use by date of 42 days after collection. The~     actual age of blood given to patients depends on what is available at the time and the rate~     of usage. During the last decade, it has been reported that blood transfusion in patients~     admitted to intensive care was associated with an independent increase of mortality. Some~     research suggests that transfusion of fresher blood might help patients in the intensive~     care unit to reach a better recovery. This project will test whether patients who receive~     'fresher' blood do better than patients who receive 'standard issue' blood.~   "
108320|NCT01638403|"~     3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the~     generation and organizations of sleep and wakefulness, first described by Westphal and~     Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main~     symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and~     hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The~     prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is~     often extremely incapacitating, interfering with every aspect of life, in work and social~     settings.~      Several breakthroughs in the understanding of physiopathology of narcolepsy have recently~     shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a~     group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic~     narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of~     orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a~     loss of hypothalamic neurons containing the orexin [Baumann CR & Bassetti CL Lancet Neurol.~     2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].~      In accordance with guidelines published by the European task force [Billiard M et al, Eur J~     Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes~     of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs~     for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and~     irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in~     the morning and one early in the afternoon, the need for amphetamines and amphetamine-like~     stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are~     main drug therapies of cataplexy.~      BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the~     orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference~     with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition,~     BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes~     during the dark period. These narcolepsy episodes are to be compared to cataplexy episodes~     in human [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show~     any effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus~     anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to~     narcoleptic patients.~      Taken together, the preclinical and clinical results provide a compelling rationale for this~     study to verify and confirm, under randomized double-blind and placebo-controlled~     conditions, the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS~     and cataplexy in narcolepsy.~      It is on the basis of preclinical studies, and on the observation of the first included~     patients, that the doses to be administered were determined.~   "
108321|NCT01638390|"~     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl~     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or~     elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25~     D.~   "
108322|NCT01638377|"~     This pilot study will explore the ways to link Ontario's remedial system for convicted~     drinking drivers to medical intervention, assess the receptiveness of the Back on Track~     client population to effective medical interventions, and assess the feasibility of a~     full-scale trial of pharmacotherapy for convicted drinking drivers.~   "
108323|NCT01638364|"~     The purpose of this study is to examine whether there is an increase in dopamine levels in~     the human striatum following an oral administration of alcohol, as has been evidenced in~     animal models. This will be a Positron Emission Tomography (PET) study using the~     radiotracer, [11C]-(+)-PHNO (11C]-( + )-4-propyl-~     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).~   "
108324|NCT01638351|"~     The purpose of this study is to investigate the effect of a 12-week progressive resistance~     training program on the skeletal muscle function, glycemic control, functional capacity, and~     quality of life in the elderly with type 2 diabetes mellitus.~   "
108325|NCT01638338|"~     The project aims to develop a new approach to risky drinkers by providing a facilitated~     website access and creating a local integrated support network.~      In order to do so:~        1. A randomised controlled study will be performed to test the hypothesis that:~           Brief intervention for risky drinkers delivered in primary care through facilitated~          access to an alcohol reduction website has equivalent or superior outcomes to face to~          face brief intervention.~        2. Barriers and incentives of Local Authorities will be evaluated with qualitative~          (semi-structured interviews) and quantitative (survey) methods~   "
108326|NCT01638325|"~     BC106 is a molecule that when injected with insulin lispro may change the speed of~     absorption of insulin lispro. The purpose of this study will be to evaluate the safety of~     BC106 insulin lispro and any side effects that might be associated with it, blood levels of~     insulin lispro after injection under the skin and how BC106 insulin lispro affects blood~     sugar after injection under the skin. There is a minimum 7 day washout between single doses.~   "
108327|NCT01638312|"~     The goal of this research is the attempt to implement a new research method based on modern~     electrochemistry successes, in particular the development of the polarographic method of~     fructose and fructose diphosphate identification and its implementation to detect the viral~     infection in early stage. There will be 20 samples from the HIV-infected patients and 30~     samples from the heath controls. The study will collect 10ml urine and examined fructose and~     fructose-diphosphate using the polarographic method.~   "
108330|NCT01638273|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained~     Absorption by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to~     enable a drug to be dissolved irrespective of the surrounding environment and further~     absorbed up to colon. The investigators coined this Geometrically Long Absorption Regulated~     System(GLARS).~   "
108331|NCT01638260|"~     - Rationale: Treatment with glucagon-like peptide 1 (GLP-1) has been shown to reduce plasma~     glucose levels to a further extent when added to standard therapy in type 2 diabetes~     mellitus. Given the well-known beneficial effects of GLP-1 analogues on glucose metabolism~     by stimulating insulin release, suppressing elevated glucagon levels, delaying gastric~     emptying and reducing food intake, it is anticipated that liraglutide developed by Novo~     Nordisk (Victoza®) also has beneficial effects in type 2 diabetes mellitus as has been~     proven by several trials. Type 2 diabetes mellitus is associated with obesity and sedentary~     lifestyle. Obesity occurs when energy intake exceeds energy expenditure (EE) over a period~     of time. It has been presumed that activity energy expenditure and daily energy expenditure~     are lower in most people in Western societies. Increasing non-exercise activity~     thermogenesis (NEAT), defined as all energy expended due to everyday activity, exclusive of~     volitional exercise, may be an effective way to maintain daily EE and combat overweight and~     obesity. One way to promote NEAT is to decrease the amount of time spent on sedentary~     behaviors (e.g. watching television).~      This leads us to hypothesize that adding NEAT to GLP-1 analogues in type 2 diabetes has an~     additive effect on glucose regulation, weight control and blood pressure. On the other hand,~     we hypothesize that a decrease in HbA1c, weight and blood pressure could add to an improved~     quality of life and less health care costs. Therefore, the primary purpose of this study is~     to determine the synergistic effect of liraglutide and activating lifestyle by increasing~     NEAT on glucose metabolism and weight. First line therapy of type 2 diabetes mellitus~     currently consists of lifestyle changes with metformin. When failure of this regime occurs,~     sulfonylurea derivates and/or thiazolidinediones can be added. One third of patients with~     type 2 diabetes mellitus fail with this regimen after 5 years of monotherapy, and nowadays~     GLP-1 analogues can be added to prevent deterioration of glycaemic control. However,~     comparison of this strategy with NEAT has not been performed and the synergistic effect of~     combination of GLP-1 with increasing NEAT has not been investigated. Treatment with GLP-1~     analogues in combination with NEAT could theoretically overcome all shortcomings of current~     treatment strategies of type 2 diabetes mellitus.~      Objective:~        -  Primary objectives~             -  To determine the change in HbA1c from baseline and end of treatment (26 weeks) and~               end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus~               liraglutide with NEAT~             -  To determine the change in weight from baseline and end of treatment (26 weeks)~               and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide~               versus liraglutide with NEAT~        -  Secondary objectives~             -  To assess the change in blood pressure from baseline and end of treatment (26~               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with~               liraglutide versus liraglutide with NEAT~             -  To assess the change in quality of life from baseline and end of treatment (26~               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with~               liraglutide versus liraglutide with NEAT~             -  To assess the change in NEAT from baseline and end of treatment (26 weeks) and end~               of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus~               liraglutide with NEAT~             -  To asses the health-care related costs at baseline, after 26 weeks of treatment~               with liraglutide versus liraglutide with NEAT, and after 52 weeks (end of~               follow-up)~      Study design: Randomized controlled intervention study~      - Study population: Men and women with type 2 diabetes mellitus, insufficiënt glycaemic~     control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea~     derivate or during combination therapy with metformin and a sulfonylurea derivate or a~     thiazolinedione, HbA1c above 7,0%, age between 40 - 75 years old, BMI above 25 kg/m2~      Intervention: One group receives once daily subcutaneously liraglutide 1.8mg added to~     standard anti-diabetic care and the other group receives once daily subcutaneously~     liraglutide 1.8mg added to standard anti-diabetic care and an activating lifestyle by~     increasing NEAT~      Main study parameters/endpoints: The main study parameter is the percent change in HbA1c and~     weight. Secondary study parameters are change in blood pressure, quality of life as measured~     using EQ-5D and SF-36 questionnaire, NEAT as measured using an activPAL™ accelerometer and~     cost-effectiveness analysis.~   "
108332|NCT01638247|"~     A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant~     or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH~     analogue in male breast cancer patients (MALE).~   "
108333|NCT01638234|"~     Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin~     may aid sleep and also has anti-inflammatory properties, and has been suggested in managing~     sleep disturbance in AD patients. However, there has been no large randomized controlled~     trials. Hence the objective of this double-blind randomized controlled study is to determine~     whether supplementing melatonin is effective in improving sleep problems in children with~     AD.~   "
108334|NCT01638221|"~     This study will be comparing the patients overall satisfaction of two different meshes used~     in laparoscopic inguinal hernia repairs.~   "
108335|NCT01638208|"~     Aim~      To compare changes in gut microbiota of IBS patients and healthy controls using next~     generation sequencing method like Illumina sequencing based on 16S rDNA profiling.~      The major objectives of the study are:~      To characterize type of bacterial species and compare diversity of the host's gut microbiota~     in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high~     through put culture-independent method like Illumina sequencing.~      To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8~     weeks.~      To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL~     #3) for more than 8 weeks.~   "
108336|NCT01638195|"~     This study is a prospective, single-institution trial wherein twenty subjects with~     refractory hypertension will receive the experimental focused ultrasound renal denervation~     therapy. Safety will be assessed by incidence and evaluation of serious adverse effects~     associated with the investigational procedure through 52-week evaluation of bilateral~     treatment. Clinical utility will also be evaluated by comparison pre and post therapy~     systolic and diastolic blood pressure and norepinephrine spillover.~   "
108337|NCT01638182|"~     The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins~     osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a~     nutritional dose range.~      The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to~     the RDA of vitamin K.~   "
108338|NCT01638169|"~     During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher~     flexion and abduction of the hip in order to advance the swinging limb. The aim of this work~     is to assess the immediate contribution of heels for these walking disturbance in children~     with muscular dystrophy disease.~   "
108339|NCT01638156|"~     This study will evaluate the importance of arterial stiffness and wave reflections as~     determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using~     cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic~     valve. The hypothesis will test whether stiff arteries and increased wave reflections impede~     pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate~     regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of~     aortic valve stenosis.~   "
108340|NCT01638143|"~     The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7)~     after intake of three different vitamin K2 supplements.~   "
108341|NCT01638130|"~     The purpose of this study is to explore the experiences and needs of patients with a~     high-grade glioma and their caregivers. Semi-structured interviews with patients and~     caregivers will be conducted and analysed using Grounded-Theory approach.~   "
108342|NCT01638117|"~     The purpose of this study is to determine the cumulative irritation potential of the~     products listed by the Sponsor.~   "
108343|NCT01638104|"~     The purpose of this study is to investigate the safety and tolerability of ANX-042 when~     administered by continuous intravenous (IV) infusion in healthy volunteers.~   "
108344|NCT01638091|"~     Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New~     technologies such as narrowband imaging (NBI) offer the possibility of in differentiation~     between precancerous and unimportant small polyps. Use of these technologies could decrease~     the costs and potentially the risks of screening and surveillance colonoscopy.~      Multiple studies have demonstrated the ability of experienced endoscopists to achieve high~     accuracy in differentiating polyp types using NBI.~      The investigators hypothesize that community-based endoscopists can learn to identify polyp~     type at colonoscopy with the aid of NBI through the use of an introductory didactic program,~     followed by practice based-learning, and that their experience can serve as guidelines for~     wider dissemination.~      The purpose of this study is to test an educational program combining a didactic program~     followed by practice-based learning that is designed to allow community-based endoscopists~     to become proficient at the use of NBI in the colon. This study will not affect the care of~     patients in any way. The research subjects will be the endoscopists, who will perform~     colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting~     to predict polyp type before resection.~   "
108345|NCT01638078|"~     Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated~     with restenosis in approximately 10% to 50% of cases.~      Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn~     delay healing and endothelialization and may lead to restenosis and atherosclerosis within~     the stented segments.~      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory~     and antioncogenic properties that could be of benefit in case of PCI with stenting.~   "
108346|NCT01638065|"~     The objective of this study is to show VeinViewer® Vision is an effective vein visualization~     device for peripheral vascular access, pre-, during, and post access.~   "
108348|NCT01638039|"~     The aim of this study is to accelerate the development of vaccine candidates against~     diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan~     to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study~     humoral and cellular immune parameters following natural infections with Shigella and ETEC,~     and to compare the level of pre-existing local, humoral and cellular immune parameters in~     cases of shigellosis and ETEC-associated diarrhea and in matched controls.~   "
108349|NCT01638026|"~     Study Objectives:~        1. To prove that the use of GnHR agonist for final oocyte maturation results in a higher~          percentage of mature oocytes than the use of hCG.~        2. To show an advantage in women's satisfaction in the proposed protocol versus the~          standard antagonist protocol In the study group women will receive GnRH agonist for~          oocyte maturation, followed by ovum pick-up which will be performed 35 hours later.~          Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will~          include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be~          obtained 14 days after embryo transfer.~   "
108350|NCT01638013|"~     The purpose of this study is to evaluate the safety and efficacy of long-term administration~     of ASP015K in patients who have completed Phase IIb or Phase III studies.~   "
108351|NCT01638000|"~     The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron~     50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were~     dissatisfied with their treatment due to lack of efficacy.~   "
108352|NCT01637987|"~     The purpose of this study is to determine if the use of a vein identification assistive~     device increases nurse PIV insertion success within the first two attempts in children 0-12~     months of age when compared to unassisted methods.~   "
108353|NCT01637974|"~     The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine~     adhesions formation after any hysteroscopic surgery.~   "
108354|NCT01637961|"~     This phase II trial studies how well alisertib works in treating patients with~     leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
108355|NCT01637948|"~     Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease~     in China over three thousand years. Certain TCM have scientifically proved to have~     anti-bacterial property. Patients having orthodontic treatment have higher risks of caries~     and gum diseases. The purpose of this study was to determine whether the use of TCM~     Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic~     patients in maintaining proper oral health.~   "
108356|NCT01637935|"~     To assess the potential association between pioglitazone and bladder cancer compared with~     non-pioglitazone users among patients with type 2 diabetes mellitus.~   "
108357|NCT01637922|"~     Otherwise healthy subjects who are currently bein maintained on either methadone or~     buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at~     least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs~     between BI 201335 and either methadone or buprenorphine/naloxone.~   "
108358|NCT01637909|"~     In hypertension, lifestyle modification has been proven to be effective in reducing blood~     pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop~     hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic~     blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been~     shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal~     to adding one antihypertensive drug. However, as the dietary pattern is different in the~     Korean population, the investigators cannot implement the data from Western countries~     directly to the Korean population. For example, the consumption of dairy products is much~     smaller in the Korean population when compared to the western population. Therefore, the~     effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean~     population is not well defined. In this study, the investigators sought to determine the~     effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood~     pressure lowering. The study will be performed on untreated prehypertension patients and~     uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood~     pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.~   "
108359|NCT01637896|"~     The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting~     balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent~     implantation in terms of restenosis~   "
108360|NCT01637883|"~     To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal~     tube cuff for postoperative sore throat.~   "
108361|NCT01637870|"~     This study is aimed at determining whether or not the use of a wound suction device placed~     on the cesarean incision instead of a standard sterile dressing will decrease the prevalence~     of wound complications and wound infections in women at high risk for post operative~     complications. The study will first look at the infection and wound complication rate in~     women 6 months prior to the start date of the study by reviewing charts of women who have~     undergone a cesarean section. The study involves placing a single use, portable wound vacuum~     over the cesarean section incision and keeping it in place for 72h. The investigators will~     then compare the rates of wound infection and wound complications between these two groups.~      It is our hypothesis that negative pressure wound systems will decrease the wound infection~     and complication rate in this high risk population.~   "
108362|NCT01637857|"~     Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal~     sphincter resting pressure. No studies have investigated a possible role of FH in anal~     fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical~     effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or~     wheat.~   "
108363|NCT01637844|"~     Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen~     (HBeAg) have an increased risk of becoming infected with HBV. This study will determine~     whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive~     pregnant women during the third trimester, in addition to standard immunoprophylaxis in~     infants, will be more effective than standard immunoprophylaxis alone at preventing HBV~     infections in these infants.~   "
108364|NCT01637831|"~     The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in~     patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published~     studies related to CPAP treatment in this patient group. The investigators aim was to assess~     the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and~     to recognize and overcome possible difficulties in CPAP initiation and acceptance by these~     patients.~   "
108365|NCT01637818|"~     Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh~     plug for inguinal hernia repair based on the following published study Randomized clinical~     trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg.~     2007 Jan;94(1):36-41.~      Primary endpoints is recurrence.~   "
108366|NCT01637805|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of~     antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant~     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.~   "
108367|NCT01637792|"~     The purpose of this study was to explore the impacts of different continuous ambulatory~     peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges~     CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in~     incident Chinese peritoneal dialysis patients.~   "
108368|NCT01637779|"~     There is no effect of a parent-directed fact sheet about pain management during childhood~     immunization and pre-test on parent learning about evidence-based pain relieving methods.~   "
108369|NCT01637766|"~     Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most~     devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal~     and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a~     clinical entity known as cord compression that manifests with progressive loss of motor~     function and sensation in the legs, as well as bladder and bowel incontinence.~      The treatment of spinal metastases is mostly palliative with the goals of improving or~     maintaining neurologic function, achieving local tumor control, and spinal stability. Most~     patients with spinal metastatic disease are currently treated effectively with radiation~     therapy and/or surgery with good results. There are however certain limitations in the~     current treatment of SMD. Radiation therapy has two important limitations: 1) if the~     targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is~     contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and~     2) there is limit on the cumulative amount of radiation dose, which means that recurrent~     tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned,~     the main limitation is that some patients are not fit for surgery because of medical~     co-morbidities.~      This phase I clinical research trial will test the hypothesis that a new minimally invasive~     treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients~     with SMD.~   "
108370|NCT01637753|"~     The purpose of the study is to determine the safety and efficacy of intracranially implanted~     Carmustine in the treatment of patients with recurrent malignant glioma.~   "
108371|NCT01637740|"~     A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic.~     Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR~     LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison~     with those of cataract myopic eyes group without pseudoexfoliation syndrome.~   "
108372|NCT01637727|"~     The primary goal of this proposed research deals with estimating the risk of developing type~     2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a~     history of GDM. In addition, this study will attempt to evaluate the effect of parity on the~     late appearance of type 2 diabetes and metabolic syndrome in this unique population.~   "
108373|NCT01637714|"~     The investigators will evaluate the efficacy of multi-strain probiotics in adults with~     diarrhea predominant irritable bowel syndrome.~   "
108374|NCT01637701|"~     The goal of this study is to compare the perioperative and postoperative characters of~     plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients~     with large prostate.~   "
108375|NCT01637688|"~     The purpose of this study is to determine growth and protein status of infants with cow's~     milk protein allergy and treated with a newly innovated amino acid formula compared to those~     with a commercial amino acid formula.~   "
108376|NCT01637675|"~     Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA~     isolated as the main pharmacologically active natural compound from a traditional Chinese~     herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has~     been known for the function of improving body functions such as activating blood circulation~     and removing blood stasis according to the theory of traditional Chinese medicine. Danshen~     and its various formula products including STS have been long-time widely used in oriental~     countries, especially China to treat various inflammatory and cardiovascular diseases for~     its pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation,~     and free radical scavenging,with negligible adverse effects observed.~      The investigator's objective is to evaluate whether STS exhibits beneficial effects on~     pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study.~     90 patients with pulmonary hypertension will be enrolled in this study.~   "
108377|NCT01637662|"~     To investigate headache score and accompanying symptoms during and after infusion of the~     natriuretic peptides.~   "
108378|NCT01637649|"~     -  This study attempts to elucidate whether stroke patients with dysphagia have reduced~          diaphragm movement during voluntary coughing, and also during deep inspiration and~          expiration than stroke patients without dysphagia.~        -  This study will also compare various spirometric measurements with the diaphragmatic~          motions.~   "
108403|NCT01637324|"~     Objectives~        1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV~          voluntary counseling and testing (VCT)~        2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment~          into care and retention of HIV-positive MSM~      Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the~     Thai Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo~     Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia~      Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants~   "
108379|NCT01637636|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown product) in the blood when taken alone and in~     combination with either rifampin or ketoconazole.~      Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain~     medications. In this study, the effect that this important enzyme has on tasimelteon is~     being studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how~     they are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme~     meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of~     Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme.~      In addition, the safety and tolerability of tasimelteon will also be assessed throughout the~     study.~   "
108380|NCT01637623|"~     The purpose of this study is to determine if two medicines (allopurinol and losartan) can~     influence heart and blood vessel health compared to placebo in patients with sleep apnea who~     are using continuous positive airway pressure (CPAP).~   "
108381|NCT01637610|"~     The investigators will test the hypothesis that in a preterm population with a gestational~     age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than~     conventional methods (speculum examination for combination of pooling, nitrazine and~     ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).~   "
108382|NCT01637597|"~     This is an exploratory study in patients with locally advanced or metastatic Non-small cell~     lung cancer. Patients who are eligible to apply for Extended Access Program of crizotinib~     must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods.~   "
108383|NCT01637584|"~     The overarching objectives of this study are: 1) To investigate the neurobiology of~     posttraumatic stress disorder (PTSD) during REM and NREM sleep relative to wakefulness; 2)~     To identify the neurobiological underpinnings of sleep treatment response to prazosin or~     placebo during wakefulness, REM sleep, and NREM sleep in OIF/OEF veterans with PTSD; and 3)~     To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM~     sleep that predict sleep treatment response. We will also explore the stability of the PET~     signal by comparing pre- and post-placebo changes in brain glucose metabolism in~     non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in~     a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks~     after the initial PET series.~      The overarching hypothesis is that PTSD is characterized by neurobiological alterations in~     the amygdala, mPFC, and brain centers involved in the regulation of NREM and REM sleep, and~     that these neurobiological changes are normalized with effective sleep treatment.~   "
108384|NCT01637571|"~     The purpose of this study is to investigate a new treatment for non-cardiac chest pain~     (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators~     would like to test its effectiveness in treating NCCP.~      The patient will undergo esophageal balloon distention testing (EBDT) before and after~     taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and~     mechanical properties of the esophagus. A catheter with a deflated balloon is placed through~     the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will~     be done throughout the study as a measurement of safety.~   "
108385|NCT01637558|"~     The aims of this project are to:~        1. To evaluate the pharmacokinetics of first line antituberculosis drugs (isoniazid,~          rifampicin, pyrazinamide and ethambutol) when applying the 2010 WHO/IUATLD dosing~          guidelines across pediatric populations (0-12 years of age, HIV infected and~          uninfected, and with varied nutritional status) in Cape Town, South Africa and~          Blantyre, Malawi.~        2. To evaluate an 8-hourly weight band-based dosing strategy for lopinavir/ritonavir using~          the commercially available lopinavir/ritonavir (4:1 ratio) in children in South Africa~          receiving rifampicin-based antituberculosis treatment.~        3. To evaluate the pharmacokinetics of nevirapine in children in Malawi receiving~          rifampicin-based antituberculosis treatment.~   "
108386|NCT01637545|"~     Postoperative nausea and vomiting (PONV) is one of the most common and distressing~     complications after anaesthesia and surgery, and may lead to serious postoperative~     complications This prospective, randomized study designed to evaluate the best injection~     time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3)~     antagonist in patients undergoing facial bone surgery.~   "
108387|NCT01637532|"~     The purpose of this interventional study is to determine the feasibility to combine standard~     chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy~     (Tocilizumab and Peg-Intron).~      This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a~     monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor~     prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian~     cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may~     represent a promising strategy to both abolish drug resistance and amplify host immunity in~     patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance~     immunogenic cell death and restore local normal DC maturation. In addition, the use of~     interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the~     anti-tumor response.~   "
108388|NCT01637519|"~     Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that~     drains the bladder), require urgent treatment with a stent to relieve the blockage. This~     tube, or ureteral stent, gives the patient relief until they can have their stone treated.~     This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones.~     This stent is designed to drain the kidney and unlike other ureteral stents, is also~     designed to widen the ureter to help the stone pass on its own.~   "
108389|NCT01637506|"~     The purpose of this study is to add to the investigators' quest to understanding stone~     disease, by evaluating the metabolites excretion in urine and its relation to microflora~     present in the stool.~   "
108390|NCT01637493|"~     The purpose of this study is to examine the safety,tolerability,pharmacokinetics and~     pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.~   "
108391|NCT01637480|"~     The purpose of this study is to determined if a lower back treatment would change the hip~     and knee muscle activities in people with and without anterior knee pain. The investigators~     hypothesized that the lower back treatment may change the hip and knee muscle activities in~     people with anterior knee pain but not in people without anterior knee pain.~   "
108392|NCT01637467|"~     Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using~     electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in~     people who are on bedrest due to critical illness in the intensive care unit. The purpose of~     this study is to determine the safety and feasibility of implementing EMS in critically ill~     patients who are on mechanical ventilation for greater than 7 days, and examine the effects~     of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these~     patients. The investigators hypothesize that EMS will be safe and feasible and that~     critically ill patients receiving EMS will show a smaller loss of muscle size and strength~     than those in the control group, who do not receive EMS.~   "
108393|NCT01637454|"~     Various vasoconstrictors have shown promising results in the management of type 1~     hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the~     management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not~     available in some countries. In the present study, the investigators evaluated safety and~     efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS~   "
108394|NCT01637441|"~     The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent~     pathology in woman which can impair quality of life and generates pelvic, urinary or sexual~     functional disorders.~      It's considered that 8 % of women will be undergo surgery in this indication before the age~     of 80 years. Numerous surgical techniques have been described and we distinguish the~     interventions according to the route (vaginal or abdominal), and according to the use or not~     of synthetic mesh (non-absorbable) to increase the anatomical results.~   "
108395|NCT01637428|"~     The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device)~     will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to~     compression stockings which is the current gold standard of care.~   "
108396|NCT01637415|"~     Although there are several tools that can be used to evaluate the severity of ongoing~     alcohol withdrawal syndrome (AWS), there is no available tool that can predict which~     patients are at risk for developing AWS at the time admission, before the patient has~     developed AWS. Unfortunately, there are severe symptoms of alcohol withdrawal (e.g.,~     seizures) which may develop early in the hospitalization, and before the development of~     other systemic symptoms which may warn medical personnel of the possibility of impeding~     alcohol withdrawal (e.g., autonomic instability, delirium). The goal of this study is to~     evaluate the psychometric properties (e.g., predictive validity) of a new tool, the~     Prediction of Alcohol Withdrawal Severity Scale (PAWSS), on identifying which patients are~     at risk for developing complicated AWS (i.e., seizures, hallucinosis, delirium tremens)~     among hospitalized, medically ill patients.~   "
108397|NCT01637402|"~     The purpose of this study is to find out what effects, good and/or bad,an increased dose of~     Abiraterone Acetate in combination with prednisone has on patients and their prostate~     cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and~     potentially effective when given to patients whose cancer has grown while taking the~     standard dose.~   "
108398|NCT01637389|"~     Fundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico~     (BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The~     premise of their safe drinking-water programs has been the installation of household~     drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed~     at the University of California, Berkeley. While the systems have been tested for safety and~     effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously~     evaluating the impact of their safe drinking-water program at the population level. FCA is~     looking to expand their safe-water program during 2009 and 2010 to newly identified~     communities that lack safe-drinking water. In order to evaluate the community level~     effectiveness of their program FCA has agreed to randomize the timing of this expansion~     which will allow the lead investigators and key personal in this protocol to conduct a~     meaningful, scientific evaluation of the impact of their program through a randomized~     stepped wedge design.~      The research described in this protocol has four (4) primary objectives:~        1. To evaluate the impact the implementation of the safe drinking-water programs has on~          rates of gastrointestinal events in rural BCS communities;~        2. To evaluate the impact of the safe drinking-water programs on concentrations of fecal~          contamination in household drinking-water in rural BCS communities;~        3. To evaluate other-health and non-water impacts on communities where the safe-water~          programs are implemented, including school and work absenteeism, and health care costs;~        4. To identify household, program and system design characteristics that affect user~          compliance with the disinfection strategies.~      The investigators hypothesize that households that receive an UV based drinking-water~     disinfection system through the safe-water program will have reduced prevalence of~     gastrointestinal illness, and reductions in fecal contamination of household drinking-water,~     measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the~     investigators hypothesize that these communities will also have reduced health care costs,~     and school and work absenteeism due to the implementation of the safe drinking-water~     programs. The investigators further hypothesize that household level characteristics and~     specific program characteristics will differentially impact user compliance, measured as the~     sustained use of the systems over the course of the study. In order to evaluate the last~     hypothesis (Objective 4) two program variations will be rolled out to inform future~     programmatic decisions. A priori the investigators do not anticipate that these program~     variations will impact population measures for Objectives 1 and 2, but the investigators~     will explore these assumptions during analysis.~   "
108399|NCT01637376|"~     The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients~     with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies~     suggested that photodynamic therapy (PDT) may be an effective treatment for patients with~     NR-NSCLC. PDT is a therapy where an external light source, such as laser, is used to~     activate a light-sensitive medicine to produce byproducts that can destroy cancer cells. In~     this study the investigators will use an experimental light sensitive medicine, Temoporfin,~     to perform interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to~     activate the light-sensitive medicine.~   "
108400|NCT01637363|"~     In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick~     leave due to psychiatric sufferings. Mental health conditions are of great consequence not~     only to the sick-listed individual but also to his/her family and to society in general and~     in socioeconomic terms.~      The aim of this project is to systematically compare psychoeducation with the various~     standard offers to sick listed individuals with mental health conditions provided by job~     centers in four municipalities.~      Psychoeducation is employed within the psychiatric healthcare system and is defined as a~     group based treatment by means of educating participants about psychiatric conditions. In~     the present project, the employed psychoeducation focuses on psyche and work life, and its~     purpose is to impart knowledge about psychiatric conditions in order to provide the sick~     listed individuals with qualifications to understand, and, thereby, improve their own~     situation. Among others, there will be information about the symptoms of various psychiatric~     conditions, diagnoses, and treatment options. Furthermore, the participants will learn about~     specific, useful, cognitive tools in regards to the barriers and difficulties they might~     experience when reentering the work force and leave sickness absence behind.~      The project is designed as a randomized clinical trial in which the participants are offered~     either 1) psychoeducation as well as the standard offer to sick listed individuals provided~     by the municipality in which the individual lives or 2) the participants are offered merely~     the standard offer to sick listed individuals provided by the municipality.~      The target group consists of recently sick listed individuals with mental health issues -~     whether diagnosed or not. The individuals must be inhabitants of the municipalities of~     Struer, Lemvig, Skive, and Holstebro.~      The outcome measure is the determined as the duration of the sickness absence, the severity~     of the psychiatric condition, self-reported health, and `locus of control´. These outcome~     measurements are assessed at baseline and after 3 and 6 months.~   "
108486|NCT01636245|"~     The purpose of this study is to evaluate the immunogenicity and safety of three consecutive~     lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.~   "
108404|NCT01637311|"~     Achalasia is a rare esophageal motility disorder, which is characterized clinically by~     symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term~     efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide~     acceptance as the procedure of choice for the management of patients with primary achalasia~     in recent years. Although good or excellent long-term symptomatic response rates can be~     achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms~     occurs in approximately 20%. Controversy exists regarding the therapy of patients with~     failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a~     new minimally invasive endoscopic myotomy technique intending a permanent cure from primary~     achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients~     with failed HM.~   "
108405|NCT01637298|"~     The goals of this application are to assess the usefulness of biomarkers, including p16~     proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV)~     types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying~     HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by~     anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it~     will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60~     months, and perform HRA and biomarkers on all clients at baseline and every 12 months.~     Information from this study would inform AIN screening and follow up approaches in~     HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.~   "
108406|NCT01637285|"~     The purpose of the study is to further evaluate the PK characteristics of PF-04856883.~   "
108407|NCT01637272|"~     multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide~     in patients with dumping syndrome~   "
108408|NCT01637259|"~     Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV.~     Antiretroviral therapy associated renal dysfunction has been predominantly described in~     terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may~     occur in the absence of significant reductions in eGFR. This substudy is an exploration of~     changes in urinary protein excretion in a randomised, open-label study to evaluate the~     efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse~     transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected~     individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI +~     PI/r regimen of combination antiretroviral therapy (cART).~   "
108409|NCT01637246|"~     This is a retrospective chart review and will assess changes in IOP after treatment with any~     fixed combination in patients who previously received monotherapy.~   "
108410|NCT01637233|"~     This substudy is a prospective, observational, open-label, randomised study within the MARCH~     study. The purpose of this substudy is to investigate the changes in cerebral function~     parameters at 5 timepoints over 96 weeks of the three different treatment arms within the~     MARCH study. The investigators hypothesise that there will be improvements in cerebral~     function in those patients randomised, as part of the parent study, into the maraviroc arms.~      the assessments in this CNS substudy will include:~        1. Neurocognitive function as assessed by a computerised testing battery called CogState;~        2. changes in cerebral metabolites as measured via 1H Magnetic Resonance Spectroscopy~          (1H-MRS)~      In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar~     puncture at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an~     ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the~     plasma.~   "
108411|NCT01637220|"~     In about 10% of preoperative anaphylactic reactions to curare (114 patients analyzed at the~     BICHAT Hospital), a classical mechanism (mast cell- and IgE-dependent) is not identified.~     The mechanisms underlying these atypical anaphylactic reactions are unknown. The~     investigators have developed at the Pasteur Institute a murine model of anaphylaxis in which~     neutrophils, IgG and Platelet Activating Factor (PAF) play predominant roles. In addition,~     preliminary results obtained at the BICHAT Hospital suggest the presence of specific IgG~     anti-quaternary ammonium in the sera of patients that had developed a shock to curare~     anesthesia, but not in controls exposed to curare anesthesia or in normal blood donors.~     Finally, the release of neutrophil extracellular traps (NETs), extracellular filaments made~     of DNA and histones, may contribute to respiratory symptoms.~      HYPOTHESIS: Neutrophils are implicated in curare-induced anaphylactic reactions in humans.~     Activated by IgG-curare complexes, which aggregate IgG receptors, neutrophils release PAF~     and NETs that are implicated in the cardiac and respiratory distress during anaphylaxis. It~     is possible that the activation of neutrophils: 1) explains the clinical features of~     atypical anaphylactic reactions (non-IgE mediated), 2) participates also in part to~     classical anaphylactic reactions~      GENERAL OBJECTIVE: Compare the percentage of circulating activated neutrophils in a group of~     patients immediately following a curare-induced shock (case) to that of a group of patients~     exposed to curare during anesthesia without developing a shock (control).~      SECONDARY OBJECTIVES: A) the day of the shock, quantify and compare between case and~     controls, 1) the level of circulating anti-quaternary ammonium IgG by immuno fluorometry, 2)~     the expression of IgG receptors (FcR) on the surface of neutrophils by cytometry, 3) the~     levels of circulating PAF by mass spectrometry, 4) the amount of NETs by immunofluorescence.~      B) 6 to 10 weeks after the shock perform, 1) cutaneous tests to curare, 2) a study of the~     capacity of stimulation of ex vivo neutrophils by IgG-curare complexes~   "
108412|NCT01637207|"~     The Investigators aim to determine how easy it is for anaesthetists to identify the~     Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in~     addition. The investigators aim to conduct a randomised single blinded trial to compare~     methods to detect the CTM.~      The first group of patients will be randomised to palpation of anatomical landmarks group.~     Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the~     trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas.~      The second group of patients will be randomised to receive ultrasound. Prior to commencing~     the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt~     tip pen. A ficidual marker will be placed on the two marked areas.~   "
108413|NCT01637194|"~     This phase I trial studies the side effects and best dose of cetuximab when given together~     with everolimus in treating patients with metastatic or recurrent colon cancer or head and~     neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of~     tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus~     may be an effective treatment for colon cancer or head and neck cancer~   "
108517|NCT01635842|"~     To understand the patients' meaning of the informed consent process in clinical trials.~      Objective of the study is:~        -  to assess, in a cohort of subjects included in clinical trials, whether the information~          and the informed Consent Forms conveyed to the patients have been understood~        -  to assess whether the choice to participate in a clinical trial is informed and aware~   "
108414|NCT01637181|"~     A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA)~     techniques in patients with insufficiency of the great saphenous vein (GSV). There are~     multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm~     Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also~     proven to be equally effective in occluding the GSV. However, little is known about~     differences in patient-related outcomes. Therefore, the primary outcomes of this comparative~     clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores~     of health related and varicose-specific questionnaires. The secondary outcomes are~     complications and effectiveness of the treatment. It is thought that possibly the 1470 nm~     ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No~     differences are expected in complication rate and effectiveness between the two treatments.~   "
108415|NCT01637168|"~     The purpose of this study is to evaluate the efficacy and safety of two different drugs in~     the treatment of patients diagnosed with memory difficulties and a decline in cognitive~     function.~      This is a parallel distribution: a group of patients will be treated with a combination~     Panax Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with~     Ginkgo Biloba (Tebonin ®).~   "
108416|NCT01637155|"~     Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery~     in deficit of vitamin D.~      Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic~     curve. Then and over the next 3 months, levels are normalized. Once normalized, will be~     administered another single oral dose to a second pharmacokinetic evaluation.~   "
108417|NCT01637142|"~     The purpose of this study is to assess the extent and rate of absorption of LY2140023 in~     healthy participants. The study has two periods. In Period 1, participants will receive a~     single oral dose of 80 mg LY2140023 followed by a 2-hour intravenous (IV) infusion of~     approximately 100 micrograms (µg) LY2140023 containing approximately 100 nCi~     [14C]-LY2140023. In Period 2, participants will receive an oral dose of 80 mg LY2140023~     followed by a 2-hour IV infusion of approximately 100 µg LY404039 containing approximately~     100 nCi [14C]-LY404039. There will be at least a 3-day washout between doses.~   "
108418|NCT01637129|"~     This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test~     tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal~     stroke.~   "
108419|NCT01637116|"~     The primary purpose of this study is to identify and characterize novel diagnostic markers~     for autoimmune urticaria, a subset of chronic spontaneous urticaria.~      Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune~     and non autoreactive / autoimmune urticaria and the quality of life impairment in these~     subsets of chronic spontaneous urticaria.~   "
108420|NCT01637103|"~     Depressive symptoms are highly frequent among cancer patients. These symptoms significantly~     impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may~     even affect patients' prognosis (e.g., through decreased adherence to cancer treatments).~     Cognitive therapy (CT) is an established treatment for depression in the general population,~     but its efficacy has not yet been investigated in non-metastatic cancer patients.~     Furthermore, because the accessibility to CT is very limited in routine cancer care and~     because many patients are reluctant to use pharmacological treatment, they often turn to~     alternative treatments such as bright light therapy (BLT), but empirical data on its~     efficacy are needed before its use can be recommended. Goal 1: To assess at post-treatment,~     as compared to a waiting-list control condition, the effect of bright light therapy (BLT)~     and cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving~     subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing~     patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3-~     and 6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and~     (2b) in improving subjective and objective parameters of sleep, in reducing fatigue and~     anxiety and in increasing patients' functioning and quality of life. It is hypothesized~     that, As compared to control patients after their waiting period, both BLT and CT groups~     will have significantly greater improvement of all symptoms at post-treatment. However, as~     compared to BLT patients, CT patients will show greater improvements of all symptoms at~     post-treatment and at 3- and 6-month follow-ups. This study will provide empirical data on~     the efficacy of two approaches for treating depressive symptoms in cancer patients in order~     to better inform the scientific community, health care providers, and patients on the most~     effective depression treatments to implement in cancer care.~   "
108421|NCT01637090|"~     CTCL is a rare form of lymphoma of the skin. While early stages are usually confined to the~     skin, later stages may spread to blood, lymph nodes and other organs. At this point,~     patients usually require systemic chemo. This study will investigate the effect of~     everolimus as treatment for recurrent or refractory CTCL. Participation in this study will~     last as long as the study doctor believes disease has not gotten worse, and patients~     continue to tolerate the study medication for a maximum of 1 year. Once off the treatment,~     patients will be followed for two years.~   "
108422|NCT01637077|"~     This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in~     patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.~   "
108423|NCT01637064|"~     By creating a registry, physicians will have the opportunity to understand the clinical~     outcomes of Myositis patients treated with Acthar. Despite the availability of clinical~     exams, muscle biopsies, and other testing, it is surmised that there may be a more important~     classification of myositis that physicians are not diagnosing which could possibly lead to~     improper treatment due to inaccurate diagnosis. There may be several types of immune and~     inflammatory myositis (IIM) that do not fit well into the typical sub classifications of~     myositis.~   "
108424|NCT01637051|"~     In a prospective randomised study two uncemented tibial components with different~     polyethylene modularities (Trabecular Metal Technology (TMT) Zimmer NexGen® monobloc and TMT~     Zimmer NexGen® modular) used for total knee arthroplasty (TKA) is evaluated. Both tibial~     component coatings are designed to provide excellent condition for bone ingrowth.~      The differences between the two tibial components are evaluated by measurements of migration~     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the~     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry~     (DEXA).~   "
108425|NCT01637038|"~     The investigators are trying to evaluate the clinical effect of remote ischemic~     postconditioning on liver graft function and postoperative renal function in subjects~     undergoing living-donor liver transplantation.~   "
108426|NCT01637025|"~     The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help~     stop bleeding in participants undergoing open cardiac, intra-abdominal (including~     retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some~     countries marketed as Tabotamp®)~   "
108427|NCT01637012|"~     To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of~     percutaneous coronary interventions in patients with coronary heart disease.~   "
108428|NCT01636999|"~     Nitrous oxide (N2O) has been used for the treatment of labor pains for over 150 years. The~     longevity of its use in clinical practice can be attributed to its excellent safety profile,~     ease of administration, and familiarity of use among health-care providers. Sedara is a~     self-administered 50% N2O, 50% oxygen gas mixture with pain relieving and anxiety reducing~     properties recently available for use in the United States (US) to treat various painful~     clnical situations, including labor pains.~      In the US, epidural or intravenous administration of narcotic medications is one of the most~     common and frequently requested treatments for patients experiencing labor pains. Although~     generally considered safe, complications are common with epidurals, including fetal~     distress, low blood pressure in the mother, respiratory distress, and headache. In our~     hospital system, the use of the synthetic intravenous painkiller, Butorphanol, is a mainstay~     of treatment for labor pains. It too can have undesirable side effects in the mother,~     including low blood pressure and breathing problems.~      Because Sedara has until recently been unavailable in the US, studies comparing its efficacy~     with other agents for labor pain have been confined to Europe, predominantly in the United~     Kingdom. Several studies have investigated the efficacy of Sedara versus inhalation and~     intravenous anesthetics in various countries. We have obtained several Sedara devices for~     use in the West Penn Allegheny Health System (WPAHS) Department of Anesthesiology and would~     like to examine its efficacy in our target population of women experiencing pain during~     early labor.~      Hypothesis - Sedara will provide equivalent or superior pain relief among term, adult~     parturients in early labor (less than 5cm cervical dilation) compared to intravenous~     butorphanol.~      Primary aim - Compare Sedara versus butorphanol in a single-blinded randomized trial with~     the main outcome measure being reduction in labor pains at various time intervals.~      Our findings may be significant in terms of improving safety and efficacy of pain relief~     among women experienceing labor pains. Given that Sedara has not been previously studied in~     the US, the results may influence current obstetrical and pain management practices.~   "
108429|NCT01636986|"~     The purpose of this study was to evaluate the performance of a novel silicone hydrogel~     contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY~     ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact~     lens-related dryness symptoms.~   "
108430|NCT01636973|"~     A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes~     patients to airway damage. Vaporizing humidifier has known to be advantages of improvement~     of oxygenation and protection of airway damage. However, there is a lack of study about the~     effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung~     ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation~     and respiratory mechanics during one-lung ventilation .~   "
108431|NCT01636960|"~     This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN~     alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after~     definitive surgical resection including complete lymphadenectomy. Participants on this study~     will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to~     receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical~     benefit.~   "
108432|NCT01636947|"~     This is an efficacy and safety study to compare aprepitant with ondansetron for the~     prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy~     (MEC) in participants with solid tumors. MECs include a number of commonly used cancer~     chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based~     regimens.~      The primary hypothesis of this study is that the Aprepitant Regimen is superior to the~     Control (ondansetron) Regimen with respect to the percentage of participants with No~     Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid~     tumors.~   "
108433|NCT01636934|"~     The goal of this clinical research study is to learn if minocycline can reduce the side~     effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this~     study, minocycline will be compared to a placebo.~      Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
108434|NCT01636921|"~     The Phase II goal of this clinical research study is to find the efficacy of this~     combination assessed by tumor response and local progression failure.~   "
108435|NCT01636908|"~     The purpose of this study is to determine intratumoral concentration of kinase inhibitors~     upon 2 weeks of treatment in tumor tissue of patients.~   "
108436|NCT01636895|"~     The study has two components: component A is a cohort study to determine the in vivo~     efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and~     component B is a cross sectional study of women delivering at the study hospitals to assess~     the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current~     context of increasing SP resistance. Results of component A and B studies will be used to~     model the relationship between the prevalence of molecular markers of SP resistance, in vivo~     efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for~     routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.~   "
108437|NCT01636882|"~     This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA~     007 trial. There may be patients who have benefitted from the study drug and who might~     benefit from further treatment. In order to accommodate those patients further treatment to~     complete 48 weeks of CVA21 intratumoral injections will be made available.~   "
108438|NCT01636869|"~     Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot~     femoral nerve block and periarticular block, so we would like to know the plasma~     concentration of bupivacaine in these patients.~   "
108439|NCT01636856|"~     Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea.~     Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator,~     breathing exercise and nasal lavage. The objectives are study the effects of therapy on~     oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on~     snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative~     expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal~     exercises) will have more modifications compared to the control group.~   "
108440|NCT01636843|"~     This trial is conducted in Europe, North America and South America. The aim of this trial is~     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared~     to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to~     patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate~     (MTX) while on a stable background of MTX therapy.~   "
108441|NCT01636830|"~     The objective of this study is to evaluate the incidence of gingival fissures according to~     the type of brush used, soft and medium.~   "
108442|NCT01636817|"~     This trial is conducted in Europe, North America and South America. The aim of this trial is~     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared~     to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to~     patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa~     biologics and are on a stable background of methotrexate (MTX) therapy.~   "
108443|NCT01636804|"~     On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical,~     released a voluntary medical device advisory regarding these leads' potential for problems~     with the silicone insulation covering one end of the lead, where it meets another section of~     the lead which is coated with a different insulating material (polyurethane). There has been~     a voluntary suspension of sales of these leads.~      There are approximately 179,000 of the above leads implanted worldwide with an estimated~     101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the~     conductor portion of the lead becoming exposed from the silicone insulation~     (externalization), and the rate of occurrence of this type of problem is conservatively~     estimated at less than one percent. However, a review done by St. Jude Medical of returned~     Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of~     patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is~     presumed that there are patients whose leads have not yet been affected by this problem, but~     whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks~     to determine what structural changes may be occurring in these leads, what signs might~     predict these changes, and what impact these changes may have on the lead and its~     performance.~   "
108444|NCT01636791|"~     Background: Common mental illness, such as anxiety disorders and depression, is the main~     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be~     effective in alleviating target symptoms of these disorders, but its effect on sick leave~     rates has not been sufficiently addressed. The investigators have developed an intervention~     called return to work (RTW), which is based in cognitive behavioral theory, that has a~     primary aim of helping sick-listed patients with common mental illness return to work. This~     new treatment has not been evaluated in a randomized controlled trial.~      Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental~     illness in a randomized controlled trial conducted in primary care. Participants will be~     randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two~     treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of~     psychiatric symptoms. This study could contribute to new knowledge regarding how to best~     treat patients on sick leave with common mental illness.~   "
108445|NCT01636778|"~     The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts~     in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000~     /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy~     and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient~     to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy~     with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate~     to a higher rate of sustained viral response.~   "
108446|NCT01636765|"~     This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema~     Assessment Scale. There is no treatment (intervention) associated with this study.~   "
108447|NCT01636752|"~     Care for people suffering from depressive symptoms should be given in a step-wise approach.~     One first step can be the provision of self-help material. Online self-help is an innovative~     way of providing self-help. The investigators want to study the effect of an interactive~     online self-help-program (Deprexis) in the treatment of mild to moderate depressive~     symptoms. Participants will be randomised to either twelve weeks of online-self help or a~     waiting-list control. Symptoms of depression and other aspects will be assessed over a one~     year period. Thereafter the controls will also receive online-self help. The investigators~     hypothesise that online self-help is superior to the control condition in alleviating~     depressive symptoms and preventing full blown depression.~   "
108448|NCT01636739|"~     This study aims to determine the incidence of intussusceptions (IS) (including suspected~     cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in~     Japan.~   "
108449|NCT01636726|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work~     Package 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate~     methodological standards for the design, conduct and analysis of Pharmacoepidemiological~     (PE) studies applicable to different safety issues and using different data sources. To~     achieve this, results from PE studies on five key adverse events (AEs) performed in~     different databases will be evaluated. Therefore, emphasis will be on the methodological~     aspects of the studies in this protocol and not on the clinical consequences of the~     association under investigation .~      Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic airway~     diseases in the western world. For both, a stepwise treatment to reduce symptoms, improve~     lung function, and prevent risk of exacerbation is recommended using several drug classes~     according to guidelines published by e.g. the Global Initiative for Asthma [GINA guideline]~     and the Global Initiative for Chronic Obstructive Lung Disease [GOLD guideline],~     respectively. Beta-2-adrenoceptor agonists (B2A) are therapeutic mainstays in treating~     asthma and COPD due to their bronchodilative effects mediated by B2A. This drug class~     consists of two types of drugs: short acting B2A (SABA) which are used as a reliever~     medication and long acting B2A (LABA) which are used as maintenance / controller medication.~     Formoterol and salmeterol are the most frequently used LABA compounds with a half-life~     between 5-15 hrs and therefore, these compounds most commonly have labelled indications for~     use twice a day. .~      Focussing on cardiac side effects of B2A one must consider that drugs with an opposite~     mechanism of action (beta-adrenoceptor-antagonists) have well-known cardio protective~     effects and are widely used in patients suffering from e.g. ischemic heart disease,~     hypertension and acute myocardial infarction (AMI)). Conversely, stimulation of cardiac~     beta-adrenoceptors as done by B2A may have deleterious cardiovascular effects particularly~     in patients with cardiac risk factors. And in fact, tachycardia and arrhythmias are~     well-known side effects of B2A confirming a cardiac influence of these drugs particularly~     after oral therapy (due to a high systemic exposure) as stated in the respective summary of~     product characteristics (SPCs), e.g. clenbuterol (Spiropent(R)). Obviously, inhaled drugs~     cause much smaller systemic exposure but cardiac side effects (e.g. arrhythmias,~     tachycardia) are also described in the respective SPCs (e.g. formoterol [Foradil(R)).~     Furthermore, cardiac side were also reported after exposure with inhaled MA (e.g.~     ipratropium [Atrovent(R)].~      Several observational studies have been performed on the association between the usage of~     inhaled B2A and the occurrence of AMI. However, these studies have produced conflicting~     results. Reasons for this variation are numerous, e.g. small number of events (AMI) leading~     to poor precision of risk estimate, potential misclassification of potential cardiac events~     versus airway-related events due to similar clinical complaints, differences in populations~     of drug users, measurement of drug exposure, and background risk of AMI. Additionally, a~     consensus document was released in 2000, redefining AMI.~      To make comparing results possible, this protocol gives guidelines for conducting studies in~     the same way in five databases and across 3 designs (cohort, nested case-control,~     case-cross-over) on the association between inhaled LABA use and AMI. The main focus is to~     evaluate the impact of study design, population and database characteristics on the~     association between inhaled LABA and AMI.~      Data will be collected from the following databases: The Health Improvement Network (THIN),~     the General Practice Research Database (GPRD), the Dutch Mondriaan project, Base de Datos~     para la Investigación Farmacoepidemiológica en Atencion Primaria (BIFAP), the National~     Databases of Denmark, and the Bavarian statutory health insurance physicians' association~     database.~   "
108450|NCT01636713|"~     This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study. The study will have 9 scheduled visits and a telephone contact~     Follow-up visit one week following the end of study treatment.~      The study primary endpoint is~      -Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169 Trough FEV1~     on Treatment Day 169 is defined as the mean of the FEV1 values obtained 23 and 24 hours~     after dosing on Treatment Day 168 (i.e. at the Week 24 visit).~      Secondary endpoints are;~        -  Mean TDI focal score at Week 24~        -  Weighted mean clinic visit FEV1 over 0 to 6 hours post-dose at Visit 2 (Day 1)~      Eligible subjects will be randomised to GSK573719/GW642444 125/25mcg, GSK573719/GW642444~     62.5/25mcg and placebo treatment groups in a 1:1:1 ratio such that of the planned 573 total~     number of randomised subjects, approximately 191 subjects will be randomised to each active~     treatment group and 191 subjects will be randomised to placebo. All treatments will be~     administered once daily in the morning by inhalation using a Novel Dry Powder Inhaler~     (NDPI).~      There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects~     who meet the eligibility criteria at Screening (Visit.1) will complete a 7 to 14 day Run-In~     period followed by a 24-week Treatment period. Clinic visits will be at screening,~     Randomisation (Day1), Day2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after~     the Week 24 Visit (also referred as Treatment Day 169). A Follow-Up contact for adverse~     event assessment will be conducted by telephone approximately 7 days after Visit 9 or the~     Early Withdrawal Visit. The total duration of subject participation, including Follow-up~     will be approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for~     use on an as-needed basis throughout the Run-In and Study Treatment Periods.~      At screening, pre-bronchodilator spirometry will be performed followed by~     post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC~     values will be used to determine subject eligibility. To further characterise bronchodilator~     responsiveness, post ipratropium testing will be conducted following completion of~     post-albuterol/salbutamol spirometry.~      Spirometry will be conducted at each post-randomisation clinic visit. Six hour post-dose~     serial spirometry will be conducted at Visit 2. Trough spirometry will be obtained 23 and 24~     hours after the previous day's dose of blinded study medication at Visits 3 to 9.~      Assessments of dyspnea will be obtained using the Baseline and Transition Dyspnoea Index~     (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnoea at~     baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change~     from baseline will be assessed using the TDI. Administration of the BDI and TDI should be~     done prior to spirometry and any other study-related procedures Disease specific health~     status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) and COPD~     Assessment Test (CAT), at baseline (Visit 2) and Visits 4, 6 and 8.~      The occurrence of adverse events will be evaluated throughout the study beginning at Visit~     2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed~     as related to study participation (e.g., study treatment, protocol-mandated procedures,~     invasive tests, or change in existing therapy) or related to a GSK concomitant medication,~     will be recorded from the time a subject consents to participate in the study up to and~     including any follow up contact.~      Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory~     tests (hematology and blood biochemistry) will be obtained at selected clinic visits.~      For determination of subject disposition, subjects will be considered to have completed the~     study, upon completion of Visit 9. There is no plan to provide any of the active study~     treatments for compassionate use following study completion.~      The Intent-to-Treat (ITT) population will be the primary population of interest, and is~     defined as all randomised subjects who have received at least one dose of the randomised~     study medication during the Treatment Period.~      Supplementary study conduct information not mandated to be present in this protocol is~     provided in the accompanying Study Procedures Manual (SPM). The SPM will provide the site~     personnel with administrative and detailed technical information that does not impact~     subject safety.~   "
108451|NCT01636700|"~     The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol~     infiltration or intravenous for tonsillectomy.~   "
108452|NCT01636687|"~     The purpose of this study is to demonstrate efficacy of autoinjector administered~     secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with~     moderate to severe chronic plaque-type psoriasis.~   "
108453|NCT01636674|"~     The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron~     Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon~     cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and~     histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and~     measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict~     tumor recurrence.~      The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and~     pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging~     of disease and early detection of recurrence.~   "
108454|NCT01636661|"~     The primary objective of this proposal is to investigate the safety of use of transcranial~     Direct Current Stimulation (tDCS)in children with hemiparesis.~      The research question, Is transcranial Direct Current Stimulation safe for use in children~     with congenital hemiparesis? relates to two hypotheses:~        1. tDCS will not produce a major adverse event, including seizure activity.~        2. No change in paretic or nonparetic hand function or cognitive status will occur.~   "
108518|NCT01635829|"~     The purpose of this study is to investigate the potential pharmacokinetic (what the body~     does to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or~     carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state~     (constant concentration of medication in the blood) in healthy participants.~   "
112893|NCT01578499|"~     This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus~     Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous~     T-Cell Lymphoma~   "
108455|NCT01636648|"~     This is a prospective, non-randomized, multi-center, non-interventional post-market study.~     The study is a post-market long-term follow-up study based on the same cohort of patients~     (148 patients) enrolled in a previous investigational study from March 2007 to December 2009~     (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites.~     Patient follow-up will take place on a yearly basis up to 10 years after the~     implant/enrollment. Medtronic ATS Inc. retains the right to terminate this study at any time~     after the 5 year followup.~      The primary objective of this study is to evaluate the safety and effectiveness of the~     Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.~      As this is an observational study, safety and efficacy data will be summarized and~     described. There is no statistically powered study hypothesis.~   "
108456|NCT01636635|"~     The purpose of this study is to evaluate the effect of aging and weight loss on iron status~     and immune response in obese women. Iron deficiency and immune impairment are two of the~     numerous complications of obesity. The central hypothesis is that obesity-induced~     inflammation causes lower iron status through decreased iron absorption and availability in~     young and older obese women. Furthermore, the investigators hypothesize that this can be~     corrected with weight loss in both young and older obese women.~   "
108457|NCT01636622|"~     The goal of this clinical research study is to find the highest tolerable dose of~     vemurafenib that can be given in combination with carboplatin and paclitaxel patients with~     advanced cancer. The safety of the study drug combination will also be studied.~      Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles~     (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or~     kill these cells.~      Carboplatin is designed to slow the growth of cancer cells by stopping them from making new~     DNA (the genetic material of cells).~      Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing~     into new cells.~   "
108458|NCT01636609|"~     The goal of the Phase 1 part of this clinical research study is to learn the highest~     tolerable dose of cytarabine that can be given with tosedostat and the highest tolerable~     dose of 5-azacitidine that can be given with tosedostat to patients with AML or MDS.~      The goal of the Phase 2 part of the study is to learn if cytarabine with tosedostat and/or~     5-azacitidine with tosedostat can help to control the disease. The safety of these~     combinations will continue to be studied.~      Tosedostat is designed to block the production of proteins that cancer cells need to grow.~     Blocking these proteins may cause the cancer cells to die.~      Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop~     the DNA from repairing itself.~      5-azacitidine is designed to block certain proteins in cancer cells whose job is to stop the~     function of the tumor-fighting proteins. By blocking these proteins, the tumor-fighting~     genes may be able to work better.~   "
108459|NCT01636596|"~     The objectives of this project are to examine amyloid burden and cognition in a group of~     subjects diagnosed with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) before~     and after a six month course of insulin delivered weekly in a controlled pulsatile~     intravenous fashion in a clinical setting. The investigators central hypothesis is~     straightforward: The investigators predict that controlled pulsed IV infusion of insulin~     will improve cognition in patients with AD, and that this improvement will be correlated~     with a decrease in amyloid burden in these patients.~   "
108460|NCT01636583|"~     A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a~     concentration of 4 mg/l has been developed. The aim of this study is to investigate whether~     the LSF strategy is advantageous in terms of zinc absorption compared to food fortification.~     This study wants to demonstrate whether aqueous zinc produced by the LSF device consumed~     within or outside meals is better absorbed than zinc from an enriched cereal-based staple~     food in healthy adults. In addition, the zinc absorption from the LSF-enriched water and~     from a fortified inhibitory cereal-based pudding will be compared.~   "
108461|NCT01636570|"~     The purpose of this study is to determine if treatment with vitamin D3 of 10,000~     International Units (IU) daily in vitamin D deficient patients for 6 months will improve B~     type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The~     investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated~     by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in~     patients with stable congestive heart failure (Class II or III).~   "
108462|NCT01636557|"~     The main purpose of this study is to evaluate the potential effects of a single dose of~     sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are~     specific for cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, and CYP1A2) in patients~     with active rheumatoid arthritis (RA). This study will also assess the safety and~     tolerability of a single subcutaneous (SC, under the skin) dose of sirukumab in patients~     with active RA.~   "
108463|NCT01636544|"~     Recent studies estimated that 15 to 20% of all cancers in humans are associated with~     viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and~     tobacco consumption have been recognized for years as the main risk factors for development~     of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or~     non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed,~     several studies have suggested the possibility that a virus could be associated with or be a~     causal agent of OSCC. The first objective is to detect and characterize the presence of~     infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from~     patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible~     define a causality link between these agents and a subset of potentially malignant disorders~     and/or OSCCs.~   "
108464|NCT01636531|"~     This multi-center, randomized, open-label, single-dose, parallel group study will assess the~     relative bioavailability, tolerability and dose-exposure relationship of a high~     concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of~     gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive~     single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and~     follow-up will be 13 weeks.~   "
108545|NCT01635478|"~     EMERGENCY CANCER PAIN MANAGEMENT HAS BEEN INCONSISTENT AND INADEQUATE ACROSS THE GLOBE. THIS~     STUDY AIMS TO KNOW EMERGENCY ROOM CANCER PAIN PATTERNS AND TREATMENT ADEQUACY IN TERTIARY~     CARE CANCER HOSPITALS.~   "
138890|NCT01236911|"~     Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in~     hospital)after moderate - severe TBI that the patients that do not developed this condition?~   "
108465|NCT01636518|"~     Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper~     chambers of the heart (called atria) and is often associated with many health problems. It~     can cause stroke, palpitations and heart failure. The management of long standing (chronic)~     AF may require additional medications and blood thinners, potentially for life. It may also~     require procedures where the heart is shocked with an electrical current to restore normal~     rhythm. Some patients require a procedure called radiofrequency ablation to address the~     arrhythmia.~      The purpose of this registry is to collect information on patients undergoing this~     combination of procedures into a database, and to then use this information for scientific~     study to improve the treatment of atrial fibrillation.~   "
108466|NCT01636505|"~     The aim of this study is to performed a randomized controlled trial to evaluate the rate of~     genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and~     GnRH-antagonist ovarian stimulation protocols.~      Patients will be prospectively randomized in two groups: the first undergoing controlled~     ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist~     ovarian stimulation regimen.~      The end-points of the study include the number of genetically and chromosomally abnormal~     embryos, the pregnancy, the implantation and the healthy baby birth rate.~      The patients included in PGS program were selected on the base of advanced maternal age,~     repeated pregnancy lost and implantation failure whereas the patients who were know to carry~     sex-linked or monogenic disorders were considered for PGD strategy.~      The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the~     exclusion factors.~   "
108467|NCT01636492|"~     This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male~     volunteers. Subjects will be randomized in cohorts to receive single oral doses of either~     bitopertin or placebo.~   "
108468|NCT01636479|"~     Primary Objectives:~        -  To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the~          characterization of dose-limiting toxicities (DLTs).~        -  To assess biological activities in patients with dedifferentiated liposarcoma during~          MTD cohort expansion.~      Secondary Objectives:~        -  Pharmacokinetic (PK) profile of SAR405838.~        -  Biomarkers in association with SAR405838.~        -  Anti-tumor activity in response to SAR405838.~        -  Food effect on SAR405838 PK.~        -  Compliance with SAR405838 treatment.~        -  Cytochrome P450 3A4/5 (CYP3A4/5) activity.~   "
108469|NCT01636466|"~     The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®)~     in preventing antibody formation in patients with chronic failing kidney transplants.~     Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the~     prevention of rejection in kidney transplant.~      The primary objective for the study is to determine whether conversion of patients with~     chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent~     allosensitization. The secondary objective will be to determine whether conversion of~     patients with chronic renal graft failure to everolimus (elimination of calcineurin~     inhibitor) will delay the onset of dialysis.~   "
108470|NCT01636453|"~     To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive~     treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal~     carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent~     and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck,~     saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath~     and a delivery wire assembly. The implant component is made of superelastic and~     biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular,~     intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to~     the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior~     communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent~     with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by~     a neck ≥4mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6~     and 12 months after enrollment.~   "
108471|NCT01636440|"~     Conditioned pain modulation is the ability of the spine to describe changes in pain~     perception, if two different painful stimulations take place. The reliability of the~     conditioned pain modulation has not been studied, the instruments used to measure the~     conditioned pain modulation are sparse and have proven difficult to use in a well~     reproductible way. This study is using an existing pain test, relying on the reflex in a~     muscle after a painful electrical stimulation. We will test 34 healthy volunteers in order~     to test the reliability of the conditioned pain modulation with the nociceptive withdrawal~     reflex combined to a ice water test.~   "
108472|NCT01636427|"~     The purpose of this study is to assess differences in the risk profile and in the coronary~     angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between~     myocardial infarction presentation and renal function will be investigated.~   "
108473|NCT01636414|"~     It is widely reported that a large percentage of total joint replacement patients receive~     allogeneic (human donor blood) blood transfusions due to perioperative blood loss with~     numbers ranging from 30% to 80%.~      The risks of allogenic blood transfusion are well documented in the literature. In addition,~     they are time-consuming: often lengthening hospital stay and decreasing the availability for~     postoperative physical therapy. Moreover, they are costly at several hundred dollars per~     unit, and allogeneic transfusions are linked with immunosuppression and increased~     postoperative infection rates and wound healing problems, which are devastating~     complications in this elective, joint replacement population. Several options are available~     for diminishing the need for allogenic blood transfusion following elective total joint~     replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and~     tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid~     in primary total joint arthroplasty, there is little information comparing one versus the~     other in terms of efficacy and economics.~      The purpose of this study is to compare the safety, effectiveness and cost benefit of~     Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total~     knee replacement surgery.~   "
108474|NCT01636401|"~     The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of~     aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
108475|NCT01636388|"~     The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell~     transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post~     AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV~     positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity~     conditioning regimens predetermined at each institutional center of the Childhood,~     Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for~     related or matched unrelated adult donor allogeneic transplant followed by donor LMP~     specific CTL infusion for three doses post AlloSCT. The investigators hypothesize that the~     addition of donor derived LMP specific CTLs will be safe and feasible.~   "
108476|NCT01636375|"~     This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the~     specific aims of this project are three-fold. First, the investigators intend to compare the~     amount of muscle atrophy and tendon damage that occurs around the hip between two~     commonly-used operative approaches: the direct-anterior approach and the posterior approach.~     Second, the investigators aim to provide baseline data on the amount of muscle atrophy and~     tendon damage that should reasonably be expected to occur with both of these approaches.~     Third, the investigators will document the degree of recovery of the periprosthetic soft~     tissues post-surgery in both patient groups.~      The investigators first hypothesis is that the posterior approach will demonstrate~     significantly more damage to the abductors, piriformis, and short external rotators than the~     direct anterior approach, which will demonstrate minimal soft tissue damage. The~     investigators second hypothesis is that both surgical approaches will cause some degree of~     baseline muscle damage and atrophy, in a predictable pattern. The investigators third~     hypothesis is that each of the surgical approaches inherently cause some degree of soft~     tissue damage, and that the periprosthetic soft tissues that are incised during the surgical~     exposure will recover in a predictable pattern which is consistent but unique within each~     group~   "
108477|NCT01636362|"~     Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25%~     Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and~     none of the exclusion criteria and have given a signed and dated informed consent. Study~     site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks~     or until the burn is healed if that occurs earlier. All dressing changes will be performed~     at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will~     be registered in a dressing log. All subjects will be consecutively allocated to a subject~     code.~   "
108478|NCT01636349|"~     The present study investigates the effects of recreational soccer in type 2 diabetic men in~     regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in~     6 month structured recreational soccer training and 10 men act as control with no change in~     lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans,~     echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting~     heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after~     12 and 24 weeks, respectively.~      The study examines the hypothesis that the high-intensity aerobic work profile combined with~     a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns,~     sudden stops) will improve glycaemic control, muscle and cardiac function and taken together~     will improve the overall health profile in type 2 diabetic men~   "
108479|NCT01636336|"~     The clinical studies propose to study the abuse-related effects of nicotine after~     progesterone administration during the follicular phase in women of reproductive age.~     Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the~     role of the HPA axis in the abuse-related effects of nicotine.~   "
108480|NCT01636323|"~     The proposed clinical studies will evaluate the acute effects of nicotine on the~     hypothalamic-pituitary-gonadal axis in women to test the hypothesis that nicotine alters~     gonadal steroid hormones, and/or disrupts feedback regulation of ovarian hormones by~     anterior pituitary hormones.~   "
108481|NCT01636310|"~     The proposed clinical studies will analyze the interactions between nicotine, alterations in~     endocrine hormones, mood and cardiovascular measures. They also intend to examine the~     contribution of gender and menstrual cycle phase. These studies hypothesize that this novel~     focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important~     for developing novel biologic approaches to treatment for nicotine abuse and dependence as~     well as advancing our understanding of the neurobiology of nicotine reinforcement.~   "
108482|NCT01636297|"~     The purpose of this study is to gain a better understanding of how exercise training affects~     motor/hand function and brain function in those diagnosed with Parkinson's disease. The~     investigators want to study if exercise will improve hand function and improve the level of~     brain activity.~   "
108483|NCT01636284|"~     This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients~     with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with~     sorafenib, and the safe administration of JX-594 in five weekly IV infusions.~   "
108484|NCT01636271|"~     The overall objective of this integrated analysis is to evaluate the clinical safety and~     efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared~     to placebo when added to standard of care in subjects with clinical manifestations of~     cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary~     Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to~     evaluate the effects of darapladib on the following endpoints: urgent coronary~     revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major~     Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first~     occurrent of MACE, Major and total coronary events as well as the individual components of~     MACE will also be evaluated descriptively.~   "
108485|NCT01636258|"~     To examine whether a lifestyle program results in weight loss and thereby delays or prevents~     progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6~     weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center.~     Participants are randomized to receive all of the following: nutrition education, exercise~     instruction, stress management instruction, and culinary education or follow usual care.~     Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure,~     diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to~     treat analysis of variance. Results will be used to help design larger randomized trial in~     the future.~   "
108487|NCT01636232|"~     The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in~     critical condition. Especially, vitamin D level below normal prolongs hospital stay and~     increases incidence of adverse prognosis and pushing up mortality of a number of diseases.~     However, it is remain unclear the relationship between vitamin D levels and critically ill,~     especially infection or sepsis. In this study, the investigators evaluate the significance~     of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin~     D's relevance to sepsis, as well as its value in severity and prognosis assessment,~     high-performance liquid chromatography and tandem mass spectrometry was used to detect the~     quantification of the total 25(OH)D in serum of critically ill patients. The investigators~     speculate that measurement of vitamin D could be taken as an indicator for diagnosis and~     assessment in critically ill patients.~   "
108488|NCT01636219|"~     The major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the~     process of chronic inflammatory of the airway, leading to the progressive damage of the~     small bronchioles and subsequently to the proximal bronchi. A connection between weaknesses~     of respiratory muscles in CF and deficits of CFTR in the muscle has been established.~     Insufficient cough in CF patients may advance re-current respiratory infections. A voluntary~     cough flow volume (C-FVC) profile incorporates the characteristics of the forced expiratory~     flow volume curve (FE-VC). The study aims to explore the correspondence of voluntary~     cough-flow-volume and maximum expiratory flow-volume maneuvers in relation to disease~     complications in CF patients.~   "
108489|NCT01636206|"~     The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution~     compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse~     events when administered BID for approximately 1 year.~   "
108490|NCT01636193|"~     This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect~     information regarding typical symptoms of intussusceptions and bloody stool in Japan.~   "
108491|NCT01636180|"~     REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg)~     administration in addition to high dose of clopidogrel continuous therapy (150 mg/day)~     results in higher inhibition of the platelets' aggregation in patients with myocardial~     infarction undergoing interventional treatment comparing to the standard therapy. Such~     treatment strategy will not cause increased risk of bleeding complications. In many trials~     treatment with to repeated loading doses of clopidogrel together with high dose of~     clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term~     therapy results, lower risk of ischemic complications. Currently, data regarding to the~     results of the above treatment are still limited.~   "
108492|NCT01636167|"~     To construct a computerized intraoperative keratometer to analyze the axis of corneal~     astigmatism accurately as well as rapidly by self-designed software during surgery.~   "
108493|NCT01636154|"~     The purpose of this study is to investigate the efficacy of fractions-based herbal~     combinations of clearing heat and promoting blood circulation treating acute ischemic stroke~     and the potential mechanism of it.~   "
108494|NCT01636141|"~     The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when~     given as a single dose and multidose to a defined area of one knee of healthy subjects.~   "
108495|NCT01636128|"~     The purpose of this study is to determine the effects of 2 drugs (sulindac and~     Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.~   "
108496|NCT01636115|"~     This study wants to understand which direction of shoulder movement and what posture of~     shoulder are best for the procedure of muscle strength testing of the muscle pectoralis~     major(PM). We will use muscle activity signals (sEMG) and force measurement to analyze the~     contribution of two parts of PM in three different contraction direction with three~     different shoulder postures.~   "
108497|NCT01636102|"~     To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated~     influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the~     antibody response to each influenza vaccine antigen, as measured by single radial hemolysis~     (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in~     adult and elderly subjects in compliance with the requirements of the current EU~     recommendations for clinical trials related to yearly licensing of influenza vaccines.~   "
108498|NCT01636089|"~     The aim of this study is to compare bicarbonates versus saline for prevention of contrast~     induced acute kidney injury in critically ill patients.~   "
108499|NCT01636076|"~     To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to~     salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with~     COPD~   "
108500|NCT01636063|"~     Surgical abortion in the late first trimester and early second trimester is usually~     performed with the aid of a cervical preparing agent, which helps to open up the uterine~     cervix for the procedure. Routine use of cervical preparants is recommended by several~     organizations during this period of pregnancy before surgical abortion, especially in~     younger women or those who have not delivered a baby, because their cervices may be more~     difficult to dilate without a preparant.~      The standard medication used for cervical preparation is misoprostol. Unfortunately,~     misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who~     use it. Another medication called mifepristone has been shown to dilate the cervix better~     than misoprostol in the first trimester, but little information exists about using~     mifepristone in the late first trimester and early second trimester.~      The investigators plan to perform a prospective, double-blind, randomized trial to evaluate~     if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants~     who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be~     recruited. Half will receive mifepristone and the other half misoprostol. The investigators~     will measure the amount of cervical dilation achieved right before a surgical abortion to~     determine if mifepristone is significantly different than misoprostol as a cervical~     preparant at this stage of pregnancy. The investigators expect that mifepristone will work~     better than misoprostol for this purpose.~      The investigators hope to generate information about mifepristone so that women and their~     health care providers can know more about mifepristone as an option for cervical preparation~     before surgical abortion.~   "
108501|NCT01636050|"~     The purpose of this study is to determine the effects of body mass-based squat training on~     body composition, muscular strength and motor fitness in adolescents.~   "
108502|NCT01636037|"~     Dopamine, a chemical in the brain, has been linked to schizophrenia for a number of years.~     More recently, there is evidence that certain areas affected in schizophrenia (e.g.~     motivation, cognition) may reflect too little dopamine, whereas symptoms like hallucinations~     and delusions have been linked to too much dopamine.~      This study is designed to evaluate the safety, tolerability, and efficacy of giving L-dopa~     (Sinemet) to see if it will improve those symptoms related to too little dopamine. L-dopa~     has been approved for other medical conditions (e.g. Parkinson's disease) and works to~     increase levels of dopamine.~      The investigators are linking this study with neuroimaging (fMRI) which will allows us to~     link any changes the investigators might find in clinical symptoms with changes in the~     brain. This information can prove useful in better understanding the mechanisms that account~     for these symptoms, as well as possible new treatments.~      At present , treatments for these other symptoms that seem important in functional measures~     of outcome (i.e. deficit symptoms, including amotivation; cognitive symptoms) in~     schizophrenia have not proven particularly effective. It is hoped that L-dopa may provide a~     treatment that is more effective; going forward, this information would also be useful in~     drug development and future lines of investigation.~        1. L-dopa will prove effective in improving deficit (also called 'primary negative' e.g.~          amotivation) and cognitive symptoms in schizophrenia.~        2. It will be well tolerated and not increase risk of psychotic symptoms when administered~          in conjunction with their regular antipsychotic medications.~   "
108503|NCT01636024|"~     The purpose of this study is to evaluate the safety profile and look at levels of AZD7594~     and biomarkers in blood when the drug is administered inhaled to healthy subjects~   "
108504|NCT01636011|"~     The purpose of this study is to investigate the effect of selected Osteopathic Manipulative~     Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD)~     in comparison to light touch. Effectiveness will be measured through pulmonary function~     tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned~     to one of the two groups: OMM treatment group or light touch group. Although OMM treatment~     has been used on PD patients, a randomized controlled study has not been done to establish~     its effect on PD respiratory function. The authors believe that this study will show OMM's~     effectiveness.~   "
108505|NCT01635998|"~     The objective of the H-FIB trial is to determine the role of renal sympathetic denervation~     in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for~     whom a catheter-based AF ablation procedure is planned. Patients will be randomized to~     either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic~     denervation.~   "
108506|NCT01635985|"~     The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is~     administered in different ways - orally, intravenously or inhaled (with four different~     devices), to healthy subjects~   "
108507|NCT01635972|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of bupropion.~   "
108508|NCT01635959|"~     The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease~     (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract~     symptoms in Egypt.~   "
108509|NCT01635946|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of atorvastatin.~   "
108510|NCT01635933|"~     The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared~     to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .~   "
108511|NCT01635920|"~     The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX®~     AQUA contact lenses.~   "
108512|NCT01635907|"~     This study is being conducted to evaluate whether the investigational drug Dovitinib, can~     shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors.~     This study will also further evaluate the safety of this drug.~   "
108513|NCT01635894|"~     The aims of the study were to attempt to answer the following questions; what proportion of~     women know how to and are able to exercise their pelvic floor and for those who cannot can~     they be trained and motivated to do so. This was a nested design comprising a prospective~     cohort study together with a controlled trial intervention after baseline assessment in the~     cohort study for a defined at-risk group.~   "
108514|NCT01635881|"~     To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA~     dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary~     arteries or bypass grafts.~   "
108515|NCT01635868|"~     Background Mesh repair reduces the risk of reoperation for recurrence in patients with small~     umbilical and epigastric hernias compared with sutured repair. However, reoperation for~     recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement~     may induce chronic pain. This study investigated the cumulated risk of recurrence after open~     mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk~     factors were evaluated for chronic pain and recurrence.~      Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary,~     elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm)~     were included. Follow-up was performed by a validated questionnaire regarding suspicion of~     recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for~     clinical examination. Recurrence was defined as reoperation for recurrence or clinical~     recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate~     analyses.~      Results~      1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate)~     and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence~     rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair~     (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured~     repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain~     (P<0.001).~      Conclusion Mesh repair halved the long-term risk of recurrence after repair for small~     umbilical and epigastric hernias without increased risk of chronic pain.~   "
108516|NCT01635855|"~     A prospective, open-label 1-month post-approval study to evaluate the short term safety of~     Belotero® Balance in the re-treatment of nasolabial folds.~   "
139724|NCT01225965|"~     To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in~     subjects of the established SALIA-cohort and the preventive effects on lung function~     decline.~   "
108519|NCT01635816|"~     The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized~     controlled single center trial to evaluate, by examining post-vaccination seroprotection~     titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine~     manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in~     comparison to a single lot of the same vaccine manufactured in the existing facility. The~     study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to~     providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA~     14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure~     for this life-saving vaccine in Bangladesh as well as provide data to support WHO~     prequalification of JE live attenuated SA 14-14-2 vaccine.~   "
108520|NCT01635803|"~     The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment~     of patients with macular edema secondary to a retinal vein occlusion (branch or central) as~     determined by the change in best-corrected visual acuity in the study eye from baseline to~     month 6.~   "
108521|NCT01635790|"~     The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in~     the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by~     the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.~   "
108522|NCT01635777|"~     Miltefosine efficacy will be >85%~   "
108523|NCT01635764|"~     Hidradenitis Suppurativa is a painful, chronic skin disease characterized by recurrent~     inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring.~     This Study is an open-label extension study available to subjects who participated in a~     prior adalimumab study who meet all the inclusion and none of the exclusion criteria. The~     purpose of this study to evaluate the long term safety, tolerability and efficacy of~     adalimumab in subjects with moderate to severe HS.~   "
108524|NCT01635751|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech~     corporation.~      GLARS(Geometrically Long Absorption Regulated System) is new solution to sustained~     absorption by extending the absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to~     enable a drug to be dissolved irrespective of the surrounding environment and further~     absorbed up to colon. The investigators coined this Geometrically Long Absorption Regulated~     System(GLARS).~   "
108525|NCT01635738|"~     Many studies had demonstrated that probiotics could be applied in the prevention and~     adjuvant treatment for allergic diseases. In this study, we investigate the effects of~     Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus~     paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used~     for adjuvant treatment of atopic dermatitis and asthma.~   "
108526|NCT01635725|"~     The purpose of this investigation is validate a new bowel preparation scale and to compare~     it to existing bowel preparation scales.~   "
108527|NCT01635712|"~     Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90.~   "
108528|NCT01635699|"~     The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty~     (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS-~     on oxidative damage.~   "
108529|NCT01635686|"~     The purpose of this study was to compare the safety and pharmacokinetic characteristics of~     DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male~     volunteers.~   "
108530|NCT01635673|"~     The purpose of this study is to determine if whole body vibration exercise improves~     insulin/glucose dynamics and bone metabolism in Latino Boys.~   "
108531|NCT01635660|"~     This research project examines the effectiveness of different video laryngoscopes in a~     out-of-hospital emergency intubation. Since in preclinical airway management severe~     incidents with esophageal failures of intubation may partly happen or rather endotracheal~     Intubation may completely fail, it is of great importance to evaluate alternative ways of~     endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been~     proven in everyday clinical practice and may clinically be superior in most situations when~     compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if~     different video laryngoscope types perform differently in the out-of-hospital setting. The~     investigators hypothesize that there would be no difference with regard to intubation time,~     intubation success, and intubation morbidity between different models of video~     laryngoscopes.~   "
108532|NCT01635647|"~     Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP~     shows efficacy against malaria infection when tested in UK volunteers using sporozoite~     challenge experiments. It is a leading candidate vaccination strategy against malaria. In~     the field, Phase I studies have been conducted in adults in Kenya and The Gambia and~     children and infants in The Gambia. The vaccination strategy appears safe and well tolerated~     in these populations, and also shows impressive immunogenicity, not significantly different~     to that seen in the UK trials where efficacy was shown. In particular, recent data from The~     Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who~     would be the ones to benefit most from such a vaccine against malaria. With this clinical~     development as background, the investigators now propose to evaluate efficacy against~     natural malaria infection in this important target group for an effective malaria vaccine,~     that is, 5-17 month infants and children living in malaria endemic areas. The proposed study~     area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.~   "
108533|NCT01635634|"~     The purpose of this randomized controlled study is to determine the effectiveness of cupping~     in patients with fibromyalgia compared to sham cupping.~   "
108534|NCT01635621|"~     The primary purpose of this multi-centre, double blind-study is to evaluate the clinical~     response of patients with moderate to severe Cohn's Disease (CD) following treatment with~     different doses and dose regimens of Olokizumab, relative to placebo.~   "
108546|NCT01635465|"~     Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a~     recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine~     plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study~     with small sample.~   "
108535|NCT01635608|"~     To visualize the localization and to measure the volume of water in the small intestine by~     T2-weighted MRI imaging after oral administration of 240 ml water (non-caloric water) and~     after administration of 240 ml water containing 25.5 g sucrose (105 kcal, caloric water).~      To measure pharmacokinetics of the probe-drugs paracetamol, talinolol and amoxicillin after~     oral administration dissolved in 240 ml non-caloric and in 240 ml caloric water.~   "
108536|NCT01635595|"~     Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors~     according to the TNM 7th ed., however controversy is pending on the unique or dual~     pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological~     patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM)~     and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic~     spreading may differ according to the type of tumor. The investigators retrospectively~     investigated the pathways of lymphatic spreading in 194 consecutive patients who received~     radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.~   "
108537|NCT01635582|"~     The purpose of the study is to determine whether a novel computer gaming hand exercise~     regimen would improve hand function, decrease pain/ stiffness and be feasible in people with~     Rheumatoid arthritis or Osteoarthritis affecting the hands.~   "
108538|NCT01635569|"~     Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in~     childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and~     medications but access to treatment is difficult and does not systematically include~     parents. The investigators will evaluate clinical and neural effects of Group-based Family~     CBT (GF-CBT), via a case-control study including: Group 1 - OCD cases receiving GF-CBT~     (N=90); Group 2 - OCD waitlist cases (N=90). Effects will be measured between baseline and~     completion of 12 GF-CBT sessions: comparing OCD severity and functioning changes between~     Groups 1 and 2.~   "
108539|NCT01635556|"~     The goal of this pilot project is to offer outpatient Dialectical Behavior Therapy (DBT)~     treatment as described in Linehan's text (1993), which is considered an effective treatment~     of borderline personality disorder. This treatment consists of weekly individual~     psychotherapy, weekly group skills training, 24 hour telephone consultation, and weekly team~     consultation meetings for therapists. The investigators program is able to offer all of~     these components except the 24 hour phone consultation (which has been modified due to~     employment/union guidelines of interdisciplinary staff working within the investigators~     health care system). This project intends to offer the treatment for a period of 6 months.~      As such, this proposed research project seeks to assess the feasibility of implementing an~     outpatient DBT program within a public health care setting in Canada. This study also aims~     to evaluate this DBT program for clinical effectiveness in its modified format.~     Specifically, the investigators will examine relevant outcomes related to patient~     functioning (e.g., depression, self-harm and suicidal behaviors, and admissions to~     hospital/ER visits) and improvement (e.g., improved quality of life, meeting work/employment~     goals) pre and post completion of this 6 month treatment program.~      The investigators hypotheses are that each patient will show improvement in all outcome~     variables (e.g., improved mood and quality of life, decreased self-harm, decreased ER visits~     and hospitalization visits, etc). The investigators also hypothesize that the investigators~     modified program will produce comparable results to those from studies of standard~     outpatient DBT.~   "
108540|NCT01635543|"~     Objective:~      The aim of this study is to investigate whether Crohn's Disease patients with peri-anal~     fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's~     Disease patients that would benefit from sexual health interventions.~      Hypothesis:~      Crohn's patients with active perianal fistulas will have decreased sexual drive,~     performance, and satisfaction than those with Crohn's Disease in remission.~   "
108541|NCT01635530|"~     The main purpose of this study is to determine whether four weeks treatment with oral~     doxycycline is as effective as three weeks treatment with intravenous ceftriaxone in~     patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics~     of Lyme neuroborreliosis and further define the manifestations and epidemiology of the~     disease in Finland.~   "
108542|NCT01635517|"~     The aims of the present study are to investigate prospectively the clinical course and~     outcome of the hospitalized heart failure patients treated with tolvaptan for management of~     fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the~     factors related with the efficacy including outcome of tolvaptan therapy.~   "
108543|NCT01635504|"~     Altered contour of the lower face is a frequent complication of human immunodeficiency virus~     (HIV). HIV facial lipoatrophy or loss of facial fat commonly results from antiretroviral~     therapy. Posterior cheek enlargement leading to a bulky and widened lower facial contour can~     also be seen in HIV. These changes can lead to significant cosmetic disfigurement and have~     an enormous psychosocial impact on patients. They also make individuals vulnerable by making~     them recognizable as persons living with HIV. Posterior cheek enlargement has not been well~     characterized. Both the parotid salivary gland and the masseter muscle are located in the~     posterior cheek region. Although parotid gland enlargement in a common complication of HIV,~     it is unknown whether enlargement of the masseter muscle also contributes. The investigators~     plan to study posterior cheek enlargement in HIV positive individuals. The investigators~     also plan to use botulinum toxin A as a novel treatment to improve the altered lower facial~     contour seen in HIV. This treatment has already demonstrated efficacy in HIV negative~     individuals with enlargement of the masseter muscle. Botulinum toxin has also been used~     safely in the salivary glands in individuals with excessive drooling resulting from~     neurological disease. In a trial HIV+ patient, the investigators have already demonstrated~     the efficacy of using botulinum toxin A in the treatment of posterior cheek enlargement,~     resulting from both parotid and masseter muscle enlargement. The investigators anticipate~     this study will increase our understanding of posterior cheek enlargement in HIV and lead to~     the development of a novel treatment for this important complication.~      The investigators hypothesize that posterior cheek enlargement in HIV+ patients will in some~     cases result from both masseter muscle hypertrophy as well as parotid gland enlargement. The~     investigators also hypothesize that the treatment of posterior cheek enlargement with~     botulinum toxin A will result in a more aesthetically appealing lower facial contour in HIV+~     patients. This has already been demonstrated in a trial HIV+ patient, in which there was a~     dramatic change in the volume of the masseter muscle and parotid gland 12 weeks after~     treatment with botulinum toxin A.~   "
108544|NCT01635491|"~     The purpose of this study is to describe gastrointestinal motility and transit times in~     healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal~     transit time (GITT) to GITT obtained using radioopaque markers.~      The investigators end points are to measure the transit times through different segments of~     the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.~      The study is descriptive and is designed to test and evaluate the usefulness of the Motilis~     3D-Transit system. The investigators hypothesize, that with the system transit times through~     different segments of the gastrointestinal canal can be measured.~      The design is made for evaluating the transit times, the inter-subject reproducibility and~     comparison with gold standard for colonic transit time measurement.~      The investigators have chosen to include 20 healthy volunteers.The study is descriptive and~     therefore power calculation is not needed.~   "
108547|NCT01635452|"~     This is a multi-center, prospective, non-interventional study of patients who have been~     diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a~     pre-operative treatment with ESMYA.~      The objectives of the study are to characterize and describe treatment with ESMYA and to~     evaluate the safety, effectiveness, and HRQL outcomes in this population~   "
108548|NCT01635439|"~     The purpose of the study was to compare the safety and efficacy of two agents used in~     induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2~     (Dinoprostone vaginal Tablet).~   "
108549|NCT01635426|"~     The study will compare the effect of Aspirin versus clopidogrel effect on uterine perfusion~     in women with unexplained recurrent pregnancy loss with decreased uterine artery pulsatility~     index.~      Null hypothesis: Women with recurrent miscarriage have the same blood flow after aspirin or~     clopidogrel treatment compared to their uterine artery pulsatility index before treatment.~   "
108550|NCT01635413|"~     This research is being done to compare the physical and quality of life benefits of two~     different types of exercise- tai chi versus strength training- for female cancer survivors~     who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to~     participants in a group that performs flexibility and relaxation exercises, which is~     expected to have different benefits than either tai chi or strength training.~   "
108551|NCT01635400|"~     The purpose of this study is to find out the correlation between uridine diphosphate~     glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of~     irinotecan in patients with small cell lung cancer.~   "
108552|NCT01635387|"~     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study~     was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor~     improves mortality and cardiovascular outcomes in these high-risk population.~   "
108553|NCT01635374|"~     Achalasia is an esophageal motility disease that usually requires surgical intervention~     (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with~     myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new~     NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that~     eliminates the need for skin incisions. All patients enrolled in this study, will have a~     thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution~     esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal~     Center. In this procedure, performed in the operating room under general anesthesia, a~     flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is~     created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower~     esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the~     mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed~     with standard endoscopic clips. Patients will be admitted to the hospital and a~     gastrograffin esophagram will be performed on post-op day 1 to rule out esophageal leak. All~     patient will have a 2-3 week post-op appointment~      Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators~     hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure~     (as determined by manometry) and improve patients symptoms and quality of life.~   "
108554|NCT01635361|"~     About 25% medicines prescribed for long term conditions are not taken as directed, and~     approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine~     Service (NMS) is a community pharmacy service that started in England in October 2011 which~     involves the pharmacist providing additional support to patients starting a new medicine for~     some breathing problems (asthma & COPD), high blood pressure, adult onset diabetes or~     medicines which reduce blood clotting. It aims to improve the way patients take their~     medicines improving outcomes and reducing costs to the National Health Service (NHS).~      The investigators will assess the effectiveness and cost effectiveness of the NMS using a~     research study where some people will receive the NMS, and some won't, so The investigators~     can look at the effect of the NMS on problems with their medicines, medicines taking and use~     of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and~     London areas.~      The investigators will recruit 500 patients from a range of different pharmacies and follow~     them up at six, ten and twenty six weeks after starting their new medicine to assess effects~     on medicines taking behaviour, patients' reported problems with medicines, referrals to~     their General Practitioner (GP) and use of NHS resources. The investigators will compare the~     data gathered from this study with that being collected routinely by all pharmacies in~     England to provide wider estimates of cost effectiveness.~      The investigators will also explore how the NMS service is being implemented by pharmacies.~     A sample of patients from the main study will be followed in more detail. This will involve~     recording the consultations with the pharmacist and also interviewing patients about their~     experience of the service. The investigators will interview the patients GP to investigate~     their views of the service. The investigators will also try to understand why people decline~     the invitation for the NMS~   "
108555|NCT01635348|"~     The purpose of this research study is to compare two different exercise treatments for~     walking problems in older adults. The investigators want to determine if participation in~     the exercise programs will improve walking and thinking abilities.~   "
108556|NCT01635335|"~     The proposed project will test an HIV prevention intervention for Latino parent-adolescents~     dyads. This randomized controlled trial will:~        1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV~          prevention intervention or a family-based General Health Promotion condition.~        2. Determine the efficacy of the Latino Family-based HIV prevention intervention from~          assessment of changes in HIV-related sexual behavior and attitudes over 18 months among~          a sample of 320 Latino parent-adolescent dyads.~        3. Determine the efficacy of the Latino Family-based HIV prevention intervention from~          assessment of changes in family relationships and parental monitoring/supervision over~          18 months among a sample of 320 Latino parent-adolescent dyads.~        4. Examine the association of other important constructs, such as religiosity,~          acculturation, cultural values, and sexual socialization with the primary outcomes.~      Based on a thorough review of the literature and preliminary data from a recent, small pilot~     study, the investigators hypotheses are:~        1. Compared to the General Health Promotion Control condition, the Family-Based HIV~          Prevention intervention will result in greater change with regard to primary outcome~          measures of safer sexual behavior (recent sexual activity, the number of unprotected~          sex acts, and intentions to use condoms) and safer HIV-related attitudes.~        2. Compared to the General Health Promotion Control condition, the Family-Based HIV~          Prevention intervention will result in greater change with regard to family~          relationships and parental monitoring/supervision through improved parent-child~          communication skills and they will mediate the intervention impact.~        3. Religiosity, acculturation, cultural values, and sexual socialization will have~          meaningful associations with the primary outcomes and will act as moderators of~          intervention impact.~   "
108557|NCT01635322|"~     The purpose of this study is to evaluate the correlation between the restoration of the~     sagittal balance and the improvement of the Quality of Life for patients with adult~     scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a~     spinal fusion surgery.~   "
108584|NCT01634971|"~     Postoperative pancreatic fistula (POPF) and other surgical complications are common after~     pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct~     is important and a stent is usually placed in the operation, but it is still controversial~     whether the stent drainage is internal or external.~   "
108585|NCT01634958|"~     Specific immunotherapy for IgE mediated sensitization to grass pollen~      4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the~     optimum dose.~   "
108586|NCT01634945|"~     The proposed project is aimed at testing two interventions, namely a highly bioavailable~     iron compound and a combination of SP plus amodiaquine for intermittent preventive treatment~     (IPT) of malaria, to reduce anaemia in very young children.~   "
108558|NCT01635309|"~     Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of~     these patients will suffer a major vascular complication. Despite the magnitude of this~     problem our capacity to predict these events is limited. Although perioperative myocardial~     infarction (MI) is the most common major perioperative cardiac complication, little is known~     about its pathophysiology. Coronary computed tomography angiography (CTA) is a potential~     non-invasive method for the detection of coronary artery disease and cardiac risk~     stratification in the non-operative setting; however, the value of this test to enhance risk~     prediction among patients scheduled for noncardiac surgery is unknown. This study is an~     international prospective cohort study to determine among patients with, or at risk of,~     atherosclerotic disease who are undergoing noncardiac surgery: 1) if preoperative coronary~     CTA has additional predictive value for the occurrence of major perioperative cardiac events~     and 2) the underlying coronary anatomy associated with perioperative MIs.~   "
108559|NCT01635296|"~     This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and~     efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous~     leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard~     induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2~     subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients~     who have relapsed or are refractory after at least one cytarabine/anthracycline containing~     regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1~     gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4~     cycles of therapy, patients in Arm A who achieve hematologic response may continue~     additional cycles until disease progression.~   "
108560|NCT01635283|"~     The primary purpose of this phase II clinical trial is to determine the safety and effect on~     survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a~     treatment for low-grade glioma patients. Other goals of this study are to determine if the~     vaccine can cause an immune response against patients' cancer cells and slow the growth of~     their brain tumors~   "
108561|NCT01635270|"~     The purpose of this study is to establish on the market and to clinically evaluate a new~     strategy of treatment for patients with locally advanced non-small cell lung cancer using~     deformable repositioning of 4D imaging.~   "
108562|NCT01635257|"~     Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high~     D-dimer level should undergo a second level diagnostic test such as Multidetector Computed~     Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is~     expensive, is not feasible in unstable patients and has contraindications. UltraSound (US)~     is safe and rapidly available even in unstable patients. Many authors evaluated the~     diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein~     Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular~     Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients~     with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE~     and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the~     diagnostic accuracy of multiorgan US.~      Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical~     suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value~     ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE~     diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA.~     PE was considered echographically present if CUS was positive for DVT or TTE was positive~     for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of~     the single and multiorgan US was calculated.~   "
108563|NCT01635244|"~     The purpose of this study is to:~        1. Assess for hemodynamic differences at rest and with exercise between three clinically~          available tissue aortic valves.~        2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV~          hypertrophy, and changes in LV systolic and diastolic function) after aortic valve~          replacement for severe aortic stenosis (AS) between three clinically available aortic~          valve bioprosthesis.~   "
108564|NCT01635231|"~     Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium-~     and water channels in the human kidney.~      Changes in the sodium-and water channel activity can be induced by blocking the sodium~     channels with diuretics in healthy subjects~   "
108565|NCT01635218|"~     The aim of this study was to determine whether individualized homeopathic treatment and~     fluoxetine are more efficient than placebo for moderate to severe depression in peri- and~     postmenopausal women.~   "
108566|NCT01635205|"~     This study examines randomized triple-blind clinical trial and the efficacy of paraspinous~     anesthetic block on the treatment of chronic pelvic pain in patients non-responsive to~     pharmacological management. Sixty patients will be randomly divided and allocated into group~     intervention (paraspinous anesthetic block) and control (placebo procedure in subcutaneous~     tissue).~   "
108567|NCT01635192|"~     Probiotics have become very popular and are by WHO defined as Live microorganisms which~     when administered in adequate amounts confer a health benefit on the host. For example,~     probiotics have been shown to contribute to improvements of abdominal discomfort and~     intestinal inflammation. The main hypothesis behind the present study is that probiotics~     influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin~     II locally in the intestinal mucosa.~   "
108568|NCT01635179|"~     To prevent bronchial aspiration during induction of anaesthesia it has been a common~     procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and~     thereby prevent aspiration. During the last ten years the efficiency of this maneuver has~     been discussed, since it probably prolong the intubation time and do not significantly~     reduces the risk of aspiration.~      The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view~     of the laryngeal inlet, during intubation with a videolaryngoscopy.~      The hypothesis is tested by a double-blinded randomized study where patients is intubated~     twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid~     pressure is blinded to the personal performing the intubation.~   "
108569|NCT01635166|"~     The purpose of this study is to monitor the performance of the DeltaMotion cup system in the~     treatment of patients with hip joint disease requiring a total hip replacement.Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments.~   "
108570|NCT01635153|"~     The objective of this randomized, controlled trial is to determine if adding a~     protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV~     will improve health outcomes. The investigators will enroll 180 HIV-positive women with~     newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the~     investigators will conduct dietary interviews, measure body composition, randomize subjects~     to receive a PCS (plus micronutritional supplements [MNS]) or control (MNS only) for the~     6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects~     will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months~     (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug~     continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on~     Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint~     will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2~     months after completion of ATT).~   "
108571|NCT01635140|"~     Hypofractionated radiotherapy reduce the patient and family burden through decreasing the~     overall treatment time. This study is to evaluate the clinical end results of the~     hypofractionated radiotherapy in DIPG compared to the conventional treatment. The~     non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital,~     stay or engagement, for more than its half with the same results.~   "
108572|NCT01635127|"~     Evaluation whether canakinumab leads to improvement of urticaria~   "
108573|NCT01635114|"~     The purpose of this study is to investigate the effects of the antioxidant resveratrol on~     liver fat content, body-composition and insulin sensitivity~      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have~     health benefits such as improving fat metabolism, insulin action, and possibly extending~     lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant~     resveratrol. resVida™ will be supplied by DSM Nutritional Products, Ltd.~      resVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     German Authority. It is regulated like a food. The makers of resVida™ make no claim that~     this supplement is meant to treat any ailment.~      This study is designed to investigate the health benefits of resveratrol.~   "
108574|NCT01635101|"~     The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV)~     acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in~     neonates and infants (age < 2 years) compared to placebo plus standard of care rescue~     opioids as well as characterize the concentration-effect relationship (PK/PD) of the~     intravenous acetaminophen as compared to the control group.~   "
108575|NCT01635088|"~     Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects~     in chronic asthma. However, they also have largely unappreciated early effects when~     initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might~     reveal such an early effect better than spirometry. The investigators sought to examine the~     onset of action and sustained effects over 4 weeks treatment of mometasone furoate as~     measured by Impulse Oscillometry System (IOS) versus spirometry.~   "
108576|NCT01635075|"~     People with schizophrenia have two- to three-times the mortality risk of the general~     population. This is primarily due to their unusually high rates of cigarette smoking, as~     well as other cardiovascular risk factors such as physical inactivity, obesity, high blood~     cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and~     mortality in this population. Over a dozen experimental studies indicate that walking and~     other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and~     smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on~     smoking measures have not been studied in smokers with schizophrenia. This study will use a~     within-subjects, repeated-measures design, in which participants will undergo 4 laboratory~     sessions (order counterbalanced across participants): (1) smoking cues followed by exercise,~     (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4)~     neutral cues followed by passive activity. Outcome measures include cigarette craving,~     nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study~     indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the~     next step in this research would be to test the effectiveness of a smoking cessation~     intervention that incorporates exercise bouts as a behavioral strategy for improving smoking~     cessation rates in this population.~   "
108577|NCT01635062|"~     The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers~     renin-angiotensin system activity.~   "
108578|NCT01635049|"~     The purpose of this research study protocol is to collect imaging data on embryos followed~     to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive~     chromosome screening (CCS) results, implantation and live birth.~   "
108579|NCT01635036|"~     The purpose of this study is to demonstrate that the Eeva™ System is compatible with the~     Eeva 12-well Dish.~   "
108580|NCT01635023|"~     Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.~   "
108581|NCT01635010|"~     Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase~     cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled~     clinical studies investigating the independent effects of OSA in the development of~     cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders~     such as inflammatory response, oxidative stress and vascular changes. The investigators~     hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular~     consequences in OSA patients would be less important.~      The purpose of this study is to analyze the effects of OSA in the absence of MS, on~     inflammatory, oxidative stress and vascular markers; to verify the influence of excessive~     daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of~     nasal continuous positive airway pressure (nCPAP)in theses parameters.~   "
108582|NCT01634997|"~     The primary objective is to identify compare SCOUT DS to random capillary glucose for~     identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.~   "
108583|NCT01634984|"~     Selected 400 cases of women with primary breast cancer who were treated with operation~     randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly~     selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy.~     Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.~   "
108587|NCT01634932|"~     Iron deficiency (ID) with or without anemia is still a main public health problem in~     sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as~     children below 5 years of age and women of reproductive age. The etiology of ID is~     multifactorial; but major causes are low iron dietary bioavailability and intake from~     monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and~     soil-transmitted helminthes. Approaches such as dietary diversification, supplementation~     with pharmacological iron doses, public health measures (e.g. deworming, malaria control)~     and food fortification with different iron compounds have notably reduced morbidity and~     mortality caused by ID but have not been universally successful. Biofortification is a new~     promising approach to combat micronutrient deficiencies such as ID. It is defined as the~     process of increasing the content and bioavailability of essential nutrients such as iron in~     crops by traditional plant breeding and/or genetic engineering. Pearl millet is a staple~     food for many people living in different areas of West Africa (e.g. Northern Benin) and~     India, two parts of the world, where ID is still widely prevalent. Therefore, pearl millet~     was one of the crops targeted for iron biofortification by HarvestPlus.~      To improve human iron status successfully, the additional iron gained through~     biofortification has to be at least as bioavailable as the iron in regular peal millet~     varieties. For that reason we are planning an iron absorption study where we will~     investigate the iron bioavailability from an iron-biofortified millet variety and compare it~     with the iron bioavailability from a regular-iron millet variety and from regular-iron~     millet fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be~     determined by incorporation of labeled iron into erythrocytes, at least 14 days after the~     administration of the test meals containing labeled iron (stable isotope technique). The~     three different test meals based on 1) regular-iron, 2) iron-biofortified and 3)~     post-harvest iron-fortified millet will be administered as multiple meals i.e. each study~     participant will consume each test meal for a period of 5 days (2 portions/day; one in the~     morning, one for lunch). Twenty apparently healthy Beninese women with a low/marginal iron~     status (serum ferritin < 25 ;g/L), non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30~     years of age with a body weight < 65 kg and normal body mass index will be included in the~     study.~      The results of the study will provide important insights on the iron bioavailability from~     regular, biofortified and post-harvest fortified staple crops such as pearl millet when~     feeding multiple meals as part of a more complex diet. The results can be applied to~     different meals based on pearl millet such as the West African millet pastes or the Indian~     flat breads.~   "
108588|NCT01634919|"~     •The purpose of this study is to compare the performance between liver biopsy and~     non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus~     ribavirin in patients with hepatitis C pre- and post-treatment~   "
108589|NCT01634906|"~     Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB)~     may be protective against atherosclerosis. However, statins may have an effect on ery-apoB.~      Objective: to investigate the effect of statins on ery-apoB levels.~      Study design: a non-randomized intervention study. Ery-apoB will be measured twice in~     volunteers who are on statin therapy for medical reasons. After a baseline measurement of~     ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by~     a second measurement of ery-apoB. Consecutively subjects will start with their original~     statin therapy again.~      Study population: patients on statin therapy aged 18 years or older.~      Intervention: temporary discontinuation of statin therapy for a period of six weeks.~      Main study endpoints: changes in ery-apoB levels.~      Risks, burden and benefits on participation: volunteers will visit the outpatient clinic~     twice, the second visit will be exactly six weeks after the first visit. The volunteers'~     general practitioner and medical specialist (internist or cardiologist) will be informed~     about their participation. Subjects have to fast for 10 hours before every visit and venous~     blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will~     discontinue their usual statin therapy for a period of six weeks. No major risks are~     involved with temporary discontinuation of statin therapy in stable chronic cardiovascular~     disease. Volunteers will receive 25 euro's in total for participation. Participation serves~     to further investigate the relation of statins and potentially beneficial binding of apoB on~     erythrocytes.~   "
108590|NCT01634893|"~     Patients with recurrent, refractory or metastatic solid tumors have a dismal prognosis with~     few viable treatment options. Hydroxychloroquine (HCQ) is an agent that has been widely used~     to treat malaria. Because HCQ also inhibits autophagy, a process central to survival of~     cancer in the face of metabolic stress, including the effects of anti-cancer therapy, it is~     now in human cancer trials combined with other agents to attempt to boost the efficacy of~     those agents. Autophagy inhibition improves the activity of sorafenib in hepatocellular~     carcinoma.~      Sorafenib is an oral multi-kinase inhibitor that blocks not only receptor tyrosine kinases~     such as KIT, VEGFR and PDGFR but also serine/threonine kinases along the RAS/RAF/MEK/ERK~     pathway.~      The investigators propose to treat patients with refractory or relapsed solid tumors with~     sorafenib, to boost its efficacy while attempting to mitigate its toxicity by combining with~     HCQ.~   "
108591|NCT01634880|"~     Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery~     followed by postoperative radiation therapy. Studies have shown the superiority of combined~     modality therapy compared to surgery alone. Despite the addition of postoperative radiation~     therapy, the five-year survival for locally advanced salivary gland malignancies is poor~     (less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR)~     is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the~     expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell~     carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation~     therapy improved both locoregional control and overall survival compared to radiation alone.~     Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated~     and more efficacious than cetuximab. Here, the investigators hypothesize that the addition~     of panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will~     improve recurrence-free survival (RFS).~   "
108592|NCT01634867|"~     This study will evaluate using intraosseous vascular access and intravenous vascular access~     to give pediatric patients the necessary medications to perform rapid sequence intubation,~     for patients with airway difficulties.~   "
108593|NCT01634854|"~     This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous~     oxytocin (Pitocin) in multiparous women who present at term for labor induction.~   "
108594|NCT01634841|"~     This will be a systematic investigation of the role of walnuts in preventing or slowing age~     related cognitive decline and age related macular degeneration. 700 subjects will be~     recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in~     Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the~     control group for a 2 year intervention. Baseline and annual data will be collected and~     analyzed.~   "
108595|NCT01634828|"~     The purpose of this study is to develop a mathematical algorithm which the investigators~     plan to use to more accurately estimate intraoperative blood loss.~   "
112310|NCT01586234|"~     The primary goal of this study is to determine if excimer laser smoothing of the cornea~     before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative~     Best Spectacle Corrected Visual Acuity (BSCVA).~   "
108599|NCT01634776|"~     Fatty acids or omega-3s are important in the human diet for brain development. Of the three~     main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3;~     docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been~     shown to be important in brain function. Conversely, little is known about the effects of~     ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes~     DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However,~     in the human diet, ALA is more readily available, more easily consumed, and less expensive~     relative to animal sources of DHA and EPA. So, it is very important that the investigators~     explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA~     conversion rate can be altered by methylation, an epigenetic form of gene expression and~     regulation. In the present study, the investigators will examine memory abilities and~     genetic baselines in 16-month-olds. The investigators will then supplement their food with~     ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data~     on memory, fatty acid status, genetic variations, and methylation. The investigators~     hypothesize that the ALA supplementation will result in an increase in the rate of ALA to~     DHA and EPA conversion through methylation and genetic variations and subsequently, memory~     abilities will improve. The data from this study will be used to design a larger R01 grant.~   "
108600|NCT01634763|"~     Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a~     single agent when administered orally to Japanese patients with tumors characterized by~     genetic alterations in anaplastic lymphoma kinase (ALK)~   "
108601|NCT01634750|"~     Background:~      - Hereditary inclusion body myopathy (HIBM) is a genetic disorder caused by mutations in a~     gene called GNE. This gene is responsible for producing a sugar called sialic acid. Low~     levels of sialic acid may cause muscle problems. Symptoms of HIBM include walking~     difficulties and muscle weakness, which usually start in a person s 20s or 30s and become~     worse over time.~      Researchers are studying a drug called ManNAc. It may be useful for treating HIBM. However,~     this drug is still being tested. Researchers want to see how ManNAc is absorbed into and~     removed from the blood. They will not be looking specifically at whether ManNAc can stop or~     slow the symptoms of HIBM.~      Objectives:~        -  <TAB>To study how MaNAc is absorbed into and removed from the blood in people with~          HIBM.~        -  <TAB>To study of safety of ManNAc in people with HIBM.~      Eligibility:~      - Individuals between 18 and 70 years of age who have HIBM.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have a 3 to 4-day inpatient stay for the main part of the study.~        -  Participants will be divided into groups of six. In each group, four will take ManNAc~          and two will take a placebo. Participants will not know which one they will receive.~        -  Participants will have a single dose of either ManNAc or placebo. They will be~          monitored for any possible side effects. Frequent blood samples will be collected~          during the 4-day stay.~        -  No treatment for HIBM will be provided as part of this study.~   "
108602|NCT01634737|"~     This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier~     polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects~     allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic~     but with a positive CAP to shrimp, to identify those at greatest risk of food reactions.~   "
108603|NCT01634724|"~     To test whether GnRHa withheld 2-3 days before ovulation trigger reduces the incidence of~     ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic~     ovaries (PCOs) who have been treated with gonadotropins for in vitro fertilization (IVF) or~     Intracytoplasmic sperm injection (ICSI).~   "
108604|NCT01634711|"~     The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft~     Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior~     cruciate ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will~     participate in this study. The hypothesis of this study is that the L-C Ligament will~     successfully regenerate the ACL with clinical outcomes similar to or better than surgical~     intervention with auto graft tissue.~   "
108605|NCT01634698|"~     The relative-dose-response test (RDR) is considered to be the most accurate method for~     evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as~     it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect~     VANS in patients suffering from chronic liver disease, factors inherent to the disease need~     to be considered, such as possible malabsorption, advanced age, a drop in synthesis and/or~     the release of retinol binding protein (RBP), which would result in an inadequate response~     to the RDR test. Thus, the objective of present study is to assess the adequacy of two~     different protocol for using the RDR test in patients with cirrhosis and cirrhosis-related~     hepatocellular carcinoma.~      Methods: The sample group was comprised of 178 patients at Federal University of Rio de~     Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at~     different stages in the progression of the disease. They were sorted into two groups,~     according to the retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample~     taken following a 12-hour fast). Following supplementation, the investigators took further~     blood samples five and seven hours later (T5 and T7). The investigators assessed VANS via~     concentrations of serum retinol and RBP, as well as by way of the RDR test. The cutoff~     points the investigators used for denoting inadequacy in the indicators retinol and RDR~     were, respectively, < 1.05 µmol/L and ≥ 20%. To classify the degrees of severity of the~     disease the investigators used the criteria established by Child & Pugh (1973).~   "
108606|NCT01634685|"~     This is a phase I study incorporating bavituximab into the care of patients with rectal~     adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no~     reference therapy as we are trying to identify the MTD of bavituximab in this combination.~   "
108607|NCT01634672|"~     The purpose of this study is to determine the prevalence of GERD among chronic kidney~     disease with peritoneal dialysis and hemodialysis in Korea.~   "
108608|NCT01634659|"~     The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily~     disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.~   "
108609|NCT01634646|"~     This observational placebo-controlled pilot study is intended to document whether or not~     Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively~     impact, (a) weight and, (b) cholesterol levels in man.~   "
108611|NCT01634620|"~     Objective: To characterize FeNO levels that may be indicative of eosinophilic airway~     inflammation in patients with chronic obstructive airways disease~      Number of participants: Approximately 200 subjects will be enrolled~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be~     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®~     User Manual~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan from the time that informed consent~     has been provided and during the study period~      Criteria for evaluations: This is an observational, pilot study and there are currently no~     plans for a formal statistical analysis. Information gained from this study may used to~     design subsequent studies in patients with chronic obstructive airways disease. Information~     collected will be summarized in a clinical study report but will not be subject to formal~     hypothesis testing~   "
108612|NCT01634607|"~     This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as~     well as effects of TDF on the patients' bone among HIV positive and negative patients.~   "
108613|NCT01634594|"~     Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or~     the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that~     have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several~     different regimens are used to lower the patient's blood pressure, such as vasodilators,~     autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the~     effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension~     is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc~     and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the~     amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore,~     the effect that these agents may have on the QTc and Tp-e intervals may not be negligible.~     The investigators of the present study found that the high dose of commonly used hypotensive~     agents tend to prolong these variabilities to some extent. This study will be able to~     provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc~     and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of~     deliberate hypotensive anesthesia.~   "
108614|NCT01634568|"~     A double-blind, randomised, placebo-controlled study of the safety, tolerability and~     pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male~     volunteers~   "
108615|NCT01634555|"~     The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on~     the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic~     acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to~     standard therapy or for which no standard therapy is available.~   "
108616|NCT01634542|"~     This multicenter, prospective, non-interventional study will evaluate the prevalence and~     characteristics of patients with persistent symptoms of schizophrenia and the course of~     their illness over 24 months.~   "
108617|NCT01634529|"~     The purpose of this study is to investigate whether V158866 is safe when given to healthy~     male subjects in single and multiple doses.~   "
108618|NCT01634516|"~     There has been an increase in asthma and allergic disease prevalence, especially in~     children. Given the high prevalence, and the associated high disease burden and costs, there~     is an urgent need to identify effective strategies for the primary prevention of asthma and~     allergy. A systematic review of the literature has found strong supportive epidemiological~     evidence of a protective role for the Mediterranean Diet (MD).~      The investigators aim is to undertake a pilot trial in a sample of pregnant women to~     establish recruitment, retention, a measurable change to a dietary intervention encouraging~     greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet~     modifications.~      This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of~     around 50 Scottish pregnant women.~      This work ultimately aims to contribute to improving health outcomes through seeking to~     reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable~     in informing the subsequent planned definitive parallel group RCT.~   "
108619|NCT01634503|"~     This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety~     profile the safety and maximum tolerated dose of GX-188E administered by electroporation in~     Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.~   "
108620|NCT01634490|"~     Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively~     evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of~     the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A~     food challenge was performed 6 and 12 months after the diagnosis to assess clinical~     tolerance acquisition. Main demographic and clinical characteristics were collected for each~     patient.~   "
108621|NCT01634477|"~     1. To describe the morbidity and clinical characteristics among HIV-infected patients and~          HIV-uninfected patients.~        2. To identify the risk factors for the complication or morbidity among HIV-infected~          patients and HIV-uninfected patients.~        3. To describe the mortality among HIV-infected patients and HIV-uninfected patients.~        4. To identify the risk factors for the cause of death among HIV-infected and~          HIV-uninfected patients.~   "
108622|NCT01634464|"~     In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the~     programming of obesity in early stages of life. This can be achieved by studying pregnant~     women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how~     these conditions could impact on fetal growth and development; the risk of obesity in the~     offspring during the first 3 years of life will be also assessed (genetic polymorphisms of~     the most recognized genes related to obesity; gene expression of placental biomarkers~     indicators of early programming, polyunsaturated fatty acids, immunological and~     pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies~     & neurodevelopmental assessment...). Moreover, the interaction of pathological maternal~     conditions with confounder factors that could have a role in the proposed outcomes will be~     also studied (maternal and child dietary intake, medical history and socioeconomic &~     environmental factors).~   "
108623|NCT01634451|"~     Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety~     Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done~     through implementation of care bundles. Ensuring that ICU patients get the correct amount~     of sedation (medicine that makes patients sleepy) is part of this bundle, but is proving the~     most difficult to get right. It's important healthcare staff (nurses and doctors) get~     sedation levels correct because too much sedation is linked with increased hospital acquired~     infections (HAIs), longer intensive care (ICU) and hospital stays, and possibly higher death~     rates. This quality improvement project will develop and introduce three interventions that~     may improve sedation practice: first, an ICU sedation education package; second, feedback of~     sedation-related performance data (graphs and charts); and third, introduction of a CE~     (Conformité Européenne - With the CE marking on a product, the manufacturer ensures that the~     product conforms with the essential requirements of European regulations) marked new~     technology designed to improve sedation management. The investigators will study the effect~     these interventions, in different combinations, have on sedation management and quality in~     the participating ICUs. Eight ICUs in Scotland will take part in the project, pairs (2 ICUs)~     will be assigned randomly to different combinations as follows: 1.Enhanced education alone,~     2. Education plus process/outcome measure feedback (graphs and charts), 3. Education plus~     introduction of a new sedation monitoring technology, or 4. Education,process/outcome~     measure feedback, and sedation monitoring technology. The investigators will evaluate which~     combinations of education, feedback, and technology provide the most patient benefit in the~     NHS. In addition both nursing & medical staff will be observed in clinical practice &~     interviewed about their clinical practice to increase understanding about sedation~     management from different view points and inform the education package content. These data~     will also help implement the findings after the research is completed if a benefit is found.~   "
108624|NCT01634438|"~     At present, coronary angiogram is usually performed either through an artery in your groin~     or wrist. An important limitation of the wrist approach is an increase rate of blockage of~     the wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease~     the risk of blockage. Early studies seem to suggest that higher dose is required to reduce~     the risk of this important complication. However, to date there has not been a definitive~     study to determine the most appropriate heparin dose for the prevention of this~     complication. The main goal of this study is to determine the appropriate heparin dose to~     prevent wrist artery blockage and to determine risk factors for developing such a~     complication.~   "
108625|NCT01634425|"~     The purpose of this study is to determine if early diagnosis and risk stratification~     acquired through pre-hospital clinical assessment, 12-lead electrocardiogram and point of~     care biomarkers will facilitate enhanced triage and treatment in patients with presumed~     non-ST elevation acute coronary syndromes (NSTEMI).~   "
108626|NCT01634412|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of~     sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in~     increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1~     and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and~     cyclobenzaprine (5 mg tablets, or 2.4 mg iv).~   "
108627|NCT01634399|"~     Objective:~      Primary objective of the present study was to compare the single dose bioequivalence of~     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated~     by a washout period of 7 days.~      Study Design:~      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study~   "
108628|NCT01634386|"~     Objective:~      Primary objective of the present study was to compare the single dose bioequivalence of~     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by~     a washout period of 7 days.~      Study Design:~      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study~   "
108629|NCT01634373|"~     Objective:~      Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate~     Tablets 300 mg.~      Study Design:~      Randomized, Two-Way, Crossover, multiple Dose, and Open-Label~   "
108630|NCT01634360|"~     A 48-month open label multi-centered extension study to evaluate the long-term safety,~     tolerability and efficacy of E2007 in patients with Parkinson's Disease with wearing off~     motor fluctuations and on period Dyskinesias.~   "
108631|NCT01634347|"~     The treatment involves administering propranolol, a medication indicated for treating high~     blood pressure. Propranolol is hypothesized to reduce the strength of drug or alcohol~     cravings (an integral factor involved in relapse), specifically when memories of substance~     use are recalled. In this study, propranolol or a placebo will be administered to patients~     participating in a drug or alcohol rehabilitation facility once a week over three or six~     weeks. After receiving propranolol or placebo, strong memories associated with substance~     craving are recalled by asking participants to read aloud a summary of a substance use~     experience. The investigators hypothesize that participants who receive propranolol will~     report fewer and less intense drug or alcohol cravings than participants who receive the~     placebo or treatment-as-usual.~   "
108632|NCT01634334|"~     The purpose of this study is to determine if real-time feedback (lights/sounds) from small~     smoke particle monitors and brief coaching will encourage parents to reduce young children's~     secondhand tobacco smoke exposure in their home.~   "
108633|NCT01634321|"~     The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot~     Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.~   "
108634|NCT01634308|"~     The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP~     compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor~     augmentation.~   "
108635|NCT01634295|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine~     monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.~   "
108636|NCT01634282|"~     The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in~     patients with type 2 diabetes by long-term administration orally for 52 weeks and to~     evaluate the efficacy of OPC-262~   "
108637|NCT01634269|"~     The primary objective of the present trial is to demonstrate the effectiveness of the~     MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small~     aortic annuli and deemed difficult for surgical operation.~   "
108638|NCT01634256|"~     The investigators performed a double-blind parallel study in a group of showing mild hepatic~     injury subjects who were given Fermented turmeric over a period of 12 weeks. The~     investigators measured liver function parameters , including ALT(Alanine Transaminase),~     AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase),~     and serum bilirubin, and monitored their blood pressure.~   "
108639|NCT01634243|"~     The primary objective of this trial is to establish the maximum maintenance dose of SPM 962~     in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by~     conducting safety evaluation of each patient following once-daily transdermal doses of SPM~     962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard~     8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation~     period) Exploratory evaluation of each patient's maintenance dose will also be conducted~     with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy~     will also be examined.~   "
108640|NCT01634230|"~     This study is in patients with acute liver failure who are not responding to standard of~     care.~   "
108641|NCT01634217|"~     This is a phase I single center dose escalation study with an extension at the best~     available dose to determine the tolerability of inducible regulatory T cells (iTregs) when~     given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral~     blood stem cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5~     dose cohorts will be tested. Once the tolerable dose is determined for iTregs, enrollment~     will continue with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF)~     graft-versus-host disease (GVHD) prophylaxis to gain further safety information and to~     provide pilot data in this treatment setting.~   "
108642|NCT01634204|"~     Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in~     the modern society, it is important to search for new strategies to counteract this. In~     contrast to in person support, the internet provides a low cost opportunity, which is able~     to reach a large part of the population. Therefore a web-based weight loss program may be an~     adequate mean for many people. Now it is hypothesised that a web-based weight loss program~     is able to support a reduction of body weight and weight-related cardiovascular risk factors~     effectively and to promote a healthier lifestyle. It is expected that program use, compared~     to a control group, results in greater reductions in body weight and cardiovascular risk.~   "
108643|NCT01634191|"~     The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics,~     and the safety of a single oral dose of 30 mg of apremilast in healthy subjects.~   "
108644|NCT01634178|"~     The purpose of the study is to evaluate the effects of a high fat meal on the~     pharmacokinetics of a single dose of 30 mg of apremilast in healthy subjects.~   "
108645|NCT01634165|"~     This study involves 2 single injections of LY2963016 and 2 single injections of Lantus.~     There will be at least 6 days between each injection.~      The study will compare LY2963016 to Lantus at two different doses.~      This study is approximately 10 weeks long, not including screening. Screening is required~     within 4 weeks of the start of the study.~   "
108646|NCT01634152|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over~     12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children~     (6 to 11 years old) with severe persistent asthma.~   "
108647|NCT01634139|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over~     48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent~     asthma.~   "
108648|NCT01634126|"~     Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening~     for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal~     occult blood testing (FOBT) has an established positive balance of benefit and risk, is the~     least expensive, and is the preferred method for nearly half of patients. A newer fecal~     screening test, the fecal immunochemical test (FIT), offers significant improvements over~     the FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous~     adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly~     sensitive and specific and it is the only FIT test approved in the US that can be processed~     in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening~     programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer~     from several limitations: they were conducted in populations not optimal for assessing~     screening performance in average risk patients in the U.S. and the studies did not clearly~     establish optimal number of samples required and cut-points for test positivity. Therefore,~     the overall goal of MY-FIT is to capitalize on the highly integrated and extensive~     electronic medical record system of the study site to collect two separate sets of data~     that, when synthesized, will provide a thorough picture of the comparative patient adherence~     to, sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT.~     Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer~     (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:~        1. Compare the sensitivity, specificity, positive predictive value, and negative~          predictive value for colorectal cancer and advanced adenoma (advanced neoplasia)~          between a single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut~          points for a positive test (n=2100).~        2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).~        3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost~          per advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut~          points for a positive test) (n=78,000).~      Answering the above questions will provide a much-needed strong evidence base for a~     best-practice, cost-effective method of using the OC-Micro FIT to screen for CRC in a~     general U.S. population.~   "
108649|NCT01634113|"~     The primary objective of this trial is to evaluate the safety and efficacy of two doses of~     tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the~     afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled~     corticosteroid (ICS) treatment.~   "
108650|NCT01634100|"~     The objectives of the trial are to investigate the effect of concurrent administration of~     rifampicin and probenecid on the pharmacokinetics of empagliflozin.~   "
108651|NCT01634087|"~     This is a study of INCB039110 in patients with chronic plaque psoriasis. This study will~     evaluate safety and efficacy parameters of INCB039110.~   "
108652|NCT01634074|"~     The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep~     therapy device.~   "
108653|NCT01634061|"~     This is an open label study of abiraterone acetate in combination with BEZ235 and~     abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate~     failure.~   "
108661|NCT01633957|"~     Until very recently, warfarin is still the best drug of choice for long-term anticoagulation~     for patients with mechanical prosthetic heart valve. However, the complication of warfarin~     account for 75 percent of the whole complication after the mechanical prosthetic heart valve~     replacement.~      Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models~     using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2)~     explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models~     have the potential to improve patient safety by reducing or eliminating serious adverse~     events. The investigators conducted a prospective, randomized, blinded, two arm trial to~     test this hypothesis.~   "
108654|NCT01634048|"~     Obesity is a major problem worldwide and current dietary interventions are not proving to be~     enough to cease the increase in levels of obesity and its detrimental side effects, such as~     nonalcoholic fatty liver disease (NAFLD).~      Existing data suggests that adjustments in the macronutrient composition of the diet, more~     specifically the protein content, may have beneficial effects on body composition and an~     antiobesegenic effect on appetite. This may be important in terms of controlling body weight~     and reducing the amount of fatty tissue within our bodies and organs, and therefore~     preventing obesity and its health related side effects.~      The investigators will perform a study to investigate whether a high protein low energy diet~     compared to a normal protein low energy diet, in overweight adults can modify appetite and~     aid loss of weight and fat mass. Subjects will receive either a high protein low energy diet~     (1.34g protein/kg body weight) or a normal protein low energy diet (0.8g protein/kg body~     weight) in the form of 2 meal replacements and one conventional meal per day with 2 snacks~     for 12 weeks.~      HYPOTHESIS In overweight subjects with the metabolic syndrome, a 12 week dietary~     intervention with a high protein low energy diet will lead to a reduced appetite, body~     weight and fat mass, more specifically to a greater fall in levels of fat in the liver and~     pancreas than a low energy normal protein diet.~   "
108655|NCT01634035|"~     The investigators are studying the correlation between Hba1c and the mean plasma glucose in~     diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess~     glycemic control over a 3 months duration in hemodialysis patients~   "
108656|NCT01634022|"~     Acupuncture is a popular complementary/alternative therapy that has been in use for~     thousands of years for the treatment of various medical and psychiatric conditions,~     including Major Depressive Disorder (MDD). In this study, the investigators applied the~     investigators acupuncture-treatment-for-depression protocol, based on Traditional Chinese~     Medicine (TCM) principles for treating MDD, to depressed patients not taking any~     antidepressant medications (a protocol that the investigators previously piloted as a~     medication augmentation therapy for partial responders with MDD).~      The investigators specifically investigated the efficacy, safety, and tolerability of this~     TCM-based protocol for such patients, as well as potential differences in outcomes between~     weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture~     monotherapy would be associated with a response rate of at least 50%, which the~     investigators defined as a decrease in depressive symptoms from the beginning to the end of~     the study of 50% or more, and that the response would be greater among patients who received~     acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that~     acupuncture would be associated with minimal side effects.~   "
108657|NCT01634009|"~     SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional~     edema is an important cause of death in children globally including Bangladesh. The death~     rate among children hospitalized for SAM is still high. Severe malnutrition in children can~     be successfully treated by using WHO guidelines with or without minor modification. Since~     the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for~     the treatment of children with SAM has gained ground, and huge amounts of RUTF are used~     particularly in African countries. RUTFs are an energy-dense lipid paste enriched with~     vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole~     milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix~     1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the~     previous inpatient model, the cost of RUTF is still considered a significant barrier to~     universal roll-out of SAM treatment and has made CTC implementation too expensive in many~     high-need countries.~      The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of~     raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy~     protein has a cost per kg protein that normally is below that of skim or whole milk powder,~     and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a~     high quality, complete protein that meets the daily protein requirements of growing children~     and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile~     that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS)~     of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when~     fed as the sole protein source at minimum recommended intake levels.~      To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of~     the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked~     intervention trial 300 SAM children aged 6 to 59 months after completion of their~     stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will~     randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving~     -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit~     at the outpatient department of this Dhaka Hospital of icddr,b.~   "
108658|NCT01633996|"~     In this research study, the investigators piloted a uniform acupuncture treatment protocol~     among adults with depression who were taking an antidepressant medication that was providing~     only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety,~     and tolerability of acupuncture augmentation treatment among this population. The~     investigators hypothesized that acupuncture as an augmentation treatment would be associated~     with a response rate of at least 50%, which the investigators defined as a decrease in~     depressive symptoms from the beginning to the end of the study of 50% or more, and that the~     response would be greater among patients who received acupuncture 2 times per week (vs. 1~     time per week). The investigators also hypothesized that acupuncture would be associated~     with minimal side effects.~   "
108659|NCT01633983|"~     Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple~     reports have indicated correlation of appearance of CSC with exposure to exogenous or~     elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids~     is upregulated in many inflammatory conditions, control of the inflammation may be~     beneficial in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX)~     is widely used to control different types of inflammation. The investigators are going to~     try an escalating doses of MTX to treat CSC under full medical supervision.~   "
108660|NCT01633970|"~     This open-label, Phase Ib study that has six treatment arms is designed to assess the~     safety, pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered~     anti-programmed death-ligand 1 [PDL1] antibody) administered with bevacizumab (Arm A) and~     with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B),~     with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with~     carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with~     locally advanced or metastatic solid tumors. The study includes dose escalation cohort for~     establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then~     expansion cohort will be initiated based on a selected dose level at or below the MTD or~     MAD.~   "
112311|NCT01586221|"~     The purpose of this study is to see if group Music Therapy and Physical Therapy will help in~     the recovery from stroke. It is hoped that music and physical therapy in a group setting~     will help physical, mental, and social well-being.~   "
108665|NCT01633905|"~     Alcohol-dependence is the most widespread addiction in Western countries and leads to a wide~     range of impairments at cerebral and cognitive levels. It has also been showed that~     alcohol-dependence is associated with emotional disturbances, particularly for the decoding~     of emotional facial expressions (EFE). In view of the crucial role played by EFE to develop~     and maintain satisfactory interpersonal relations, this emotional processing impairment may~     have deleterious consequences on alcohol-dependent patient's social well-being, and this~     deficit is thus of particular clinical interest. Nevertheless, this deficit has up to now~     been evaluated only by means of experiments using paradigms with low ecological value (i.e.~     presentation of EFE in isolation and in the central vision field), while in the real life,~     emotional stimuli are most frequently appearing together with other emotional stimulations~     (particularly voices) and in the peripheral vision field. Moreover, the cerebral correlates~     of this emotional deficit are still to be determined.~      The present study thus aims at exploring the Emotional Facial Expressions (EFE) decoding in~     alcoholism using a more ecological paradigm, based on peripheral presentation of emotional~     crossmodal stimuli (i.e. the simultaneous presentation of emotionally congruent face and~     voice).~      Main aim: Determining the electrophysiological characteristics (latencies and amplitudes) of~     the event-related components elicited among recently detoxified alcohol-dependent~     participants, while performing an emotion-detection task on crossmodal stimuli (voices~     and/or faces) presented centrally or peripherally, and comparing these characteristics with~     those obtained among paired healthy participants.~      Secondary objectives:~        -  Exploring the electrophysiological pattern modifications among alcohol-dependent~          participants for the emotional faces and voices decoding (unimodal conditions), using~          spatio-temporal analyses methods.~        -  Exploring the electrophysiological waves associated with peripheral crossmodal stimuli~          processing among healthy participants.~        -  Exploring the behavioral correlates (reaction times and accuracy) of the~          emotion-detection task among alcohol-dependent participants while processing peripheral~          stimuli.~        -  Exploring the psychopathological comorbidities among alcohol-dependent participants and~          their influence on the behavioral and electrophysiological results.~   "
108666|NCT01633892|"~     Traumatic facial injuries, especially those sustained in military combat, are characterized~     by destruction of bone and soft tissue. While the bony structures of the face can be~     reconstructed, it is difficult to return the soft tissue back to its original form. Many~     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of~     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat~     is taken from areas throughout the body, usually the thighs or abdomen, with a small~     liposuction tube. The fat is then transferred into the area that has lost volume or~     fullness. The fullness of the soft tissue area may decrease over time because the~     transferred fat can be reabsorbed by the body. Altering the current fat grafting procedure,~     slightly, could lead to less reabsorption and a lasting fullness of the soft tissue area~     outcome of the fat graft procedure.~      The investigators are conducting this research study to help us improve the surgical~     treatment of people who have suffered facial soft tissue loss as a result of trauma. The~     goal of this research study is to see how each person's fat grafts will maintain the fat~     over time and to measure the quality of life during a 9 month post-surgical follow-up~     period. The total duration of participation is approximately 11-12 months. In this study,~     the investigators will concentrate the fat in the fat grafting procedure to determine~     whether this process will maintain the fat over time. The areas treated with enhanced fat~     grafts will be compared with areas treated with standard of care fat grafts. At least two~     areas of your face will be treated with fat grafts, (standard of care fat grafts and~     concentrated fat grafts).~      This study is the second of two clinical studies at the University of Pittsburgh using each~     person's fat graft with concentration of fat cells in the graft to observe if there is less~     fat resorption compared to using fat grafts alone. Each study is using a different~     concentration of fat in the fat graft compared to the first clinical study.~   "
108667|NCT01633879|"~     This study tests the effectiveness of the bilingual Health and Success program, which aims~     to support Latino parents and schools in their efforts to promote the academic success and~     healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of~     HIV/AIDS in urban Latino communities.~   "
108668|NCT01633866|"~     The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil~     magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center~     (CCHMC).~   "
108669|NCT01633853|"~     It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the~     Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3~     (Rocaltrol) in the patients with CKD stage 3-5.~   "
108670|NCT01633840|"~     This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to~     be used in blinded low-dose food challenges.~   "
108671|NCT01633827|"~     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.~     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an~     increased risk for developing high blood pressure. Currently, the best treatment for~     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose~     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the~     upper airway from closing in most people, many people have difficulty sleeping with the mask~     in place and therefore do not use the CPAP treatment. This research study is being conducted~     to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will~     improve OSA severity by altering some of the traits that are responsible for the disorder.~   "
108672|NCT01633814|"~     Older women have an exaggerated increase in blood pressure during exercise. However, the~     reasons for this are unclear. It is important to investigate this phenomenon because a~     greater blood pressure response to exercise has been associated with an increased risk of~     stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is~     the profound change in hormone levels (i.e. estrogen and progesterone) associated with~     menopause. The influence of changes in estrogen and progesterone levels on the~     cardiovascular responses to exercise is poorly understood. However, it has been suggested~     that these hormones might change the responsiveness of the cardiovascular system. Possible~     mechanisms that could account for these changes are the arterial baroreflex and feedback~     from the exercising muscle (known as the exercise pressor reflex), both of which are known~     to powerfully modulate blood pressure during exercise. However, to date, few human studies~     have thoroughly examined the influence of changes in hormone levels on baroreflex function~     during exercise or the exercise pressor reflex in older women. As such, the purpose of this~     research project is to assess baroreflex function and the exercise pressor reflex in older~     women after transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone~     alone and placebo.~   "
108673|NCT01633801|"~     Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP.~     The delivery of high flows decreases dilution of the inhaled oxygen and, by matching~     patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole~     inspiratory phase. In addition, a flow-dependent effect of continuous positive airway~     pressure, possibly due to an air entrainment mechanism, has been documented in healthy~     volunteers and in patients with COPD.~      The investigators working hypothesis is that the use of post-extubation CPAP delivered via~     nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2~     values than infants extubated on to oxygen therapy.~   "
108674|NCT01633788|"~     This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in~     patients with meibomian gland dysfunction (MGD) in the eyelids.~   "
108675|NCT01633775|"~     The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those~     of Ahmed glaucoma valve implantation in secondary surgical management of patients with~     primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.~   "
108676|NCT01633762|"~     The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose~     metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1,~     insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure~     (REE) 3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4)~     levels of markers of bone formation and resorption as well as serotonin, 5) markers of~     systemic inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood~     and saliva. Thus, the overall objective is to provide detailed knowledge on the~     physiological role of gut microbiota combined with bioinformatic analyses of the functional~     implications of changes in bacteria composition on the level of both species and phylum.~   "
108677|NCT01633749|"~     Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013~     season for the prevention of influenza infection. The immunizing effect is being~     investigated, as well as its tolerability and safety.~   "
108678|NCT01633736|"~     This study's main aim is to look at targeted strength training for muscles at the hips.~     Specifically to consider whether targeted strength training not only effects strength of the~     specific muscles but also ability to stand on one leg (single leg balance) as well as~     walking in children with cerebral palsy? This study is a feasibility of method of~     investigation.~   "
108679|NCT01633723|"~     DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled,~     single/multiple dosing, dose escalation clinical trial with open-labelled food effect study~     of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after~     oral administration in healthy male subjects.~   "
108680|NCT01633710|"~     The study will compare Padd, a non-invasive automated optical device which uses a functional~     test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI)~     in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants~     drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease~     referral centre. The study hypothesis is that Padd performs at least as well as ABPI in~     detecting PAD.~   "
108681|NCT01633697|"~     The investigators hypothesize that education will improve exercise capacity, symptoms and~     quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition,~     the investigators are interested in determining how education might alter various chemicals~     in the blood and exhaled breath that reflect inflammation in the lungs and the body as a~     whole.~      The investigators plan to enroll 42 patients into this study, with half of them~     participating at each of the two sites, Vermont Lung Center at the University of Vermont in~     Burlington, Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will~     undergo a series of measurements and tests at the beginning of the study, receive formal~     education about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session,~     and finally return after 12 weeks for repeat measurement and testing as was done at the~     beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise~     during the study.~   "
108682|NCT01633684|"~     Because the diabetics are fracturing at a younger age than the general population (12), this~     leads us to believe there are significant factors that lead to fracture in Type 1 diabetes~     mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on~     BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data~     exists on pQCT in adults with Type 1 DM.~      Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral~     density (BMD) as measured by DXA compared to age and sex matched healthy controls.~   "
108683|NCT01633671|"~     In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care~     unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers~     were measured according to the standard hospital protocol. To definitively confirm or~     exclude APE, all patients underwent an angiographic CT-scan of the thorax.~   "
108684|NCT01633658|"~     The investigators hypothesize that native vitamin D will have more variability in 25(OH)D~     dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be~     a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500~     μg native vitamin D given orally.~   "
108685|NCT01633645|"~     The primary objective of this study is to establish the objective response rate (complete~     response + partial response) following treatment with VELCADE in combination with cisplatin~     plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV~     non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for~     advanced disease~   "
108686|NCT01633632|"~     The purpose of this study is to determine whether Hatha Yoga can improve the chances of a~     successful smoking quit attempt.~   "
108687|NCT01633619|"~     The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and~     are reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at~     any time after implantation and the risk of infection remains during the entire prosthesis~     indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity~     and costs to the healthcare system. Evidence for optimal management of PJI with best outcome~     and lowest expenses is limited and recommendations between countries vary significantly.~     There is unmet need to standardized diagnostic procedures and definition of infection as~     well as achieve a consensus for uniform treatment guidelines.The European Implant Cohort~     Study (EICS) is a multicenter European research project, including patients with PJI in a~     cohort representative for Europe. The EICS is established jointly by the Orthopedic and~     Traumatology surgeons, Infectious Diseases specialists and microbiologists of selected~     university and non-university institutions across Europe. The principal aim of the EICS is~     to improve the management of PJI and develop consensus guidelines across Europe. By~     systematic analysis of consecutively included patients with PJI, factors associated with~     best outcome regarding infection (assessed by the infection-free interval) and joint~     function (assessed by the degree of pain, mobility, range of motion) will be determined in a~     longitudinal prospective study with long-term follow-up. This is an investigator-initiated,~     open, prospective, multicenter observational study. Participating study centers will be~     university or non-university hospitals across Europe, which fulfill the following study~     conditions:~        -  Close collaboration between infectious diseases specialists, microbiologists and~          orthopedic/trauma surgeons,~        -  Availability of appropriate microbiological methods (following standard recommendations~          including sonication of removed prosthesis),~        -  Availability a dedicated study team (study nurse and/or research fellow) for regular~          eligibility screenings, patient inclusion procedure, real-time data collection and~          patient follow-up.~      This project may generate important scientific evidence for future guidelines regarding~     management of PJI, has the potential to initiate new multicenter substudies in an establish~     network, and may open further collaboration and exchange of skills between institutions~     across Europe.~   "
108712|NCT01633294|"~     The aims of this study are to determine whether antibiotics administered routinely in women~     presenting with premature rupture of membranes later than the 37+0 weeks of gestation can~     alter the rate of maternal and neonatal infection and to compare these rates between prompt~     (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to~     antibiotic prophylaxis.~   "
108688|NCT01633606|"~     The aim of the study is to develop a screening instrument, based on the nursing activities~     score, by which we can distinguish medium care patients from the intensive care patients in~     terms of nurse staffing.~      The main study question is: What is the most discriminative NAS cut off for medium care~     patient?~      Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is~     admitted to the 8 participating units.~      Nurses will be asked to answer 3 questions (see detailed description here under)at the end~     of their working shift concerning each patient appointed to them.~      Each morning medical staff and head nurses will be asked 2 questions (see detailed~     description here under) for concerning patient admitted to there ward.~      In order to determine the NAS cut off for medium care patient, all morning questionnaire~     scores will be compared to the NAS an TISS28 scores of that same morning.~      Secondary study questions are:~        -  Can NAS score based on one nursing shift predict the severity of care in the subsequent~          nursing shift?~        -  Is there a difference in appreciation of severity of care between nurses, head nurses~          and medical staff?~        -  Which variables influence the perception of severity of care?~        -  How does NAS relate to TISS28, APACHE and NEMS?~   "
108689|NCT01633593|"~     Nowadays features for the diagnosis of delirium are:~        1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with~          reduced ability to focus, sustain or shift attention;~        2. A change in cognition (such as memory deficit, disorientation, language disturbance) or~          the development of a perceptual disturbance that is not better accounted for by a~          pre-existing or evolving dementia;~        3. The disturbance develops over a short period of time (usually hours to days) and its~          severity fluctuates during the course of the day;~        4. There is evidence from the history, physical examination, or laboratory findings that~          the disorder is caused by the direct physiological consequences of a general medical~          condition, substance intoxication or substance withdrawal.~      Treatment of underlying clinical disease is important to remit the delirium. However, these~     procedures alone are not enough to remit the delirium early and to prevent sequels. There is~     a need for a specific and faster strategy to treat the delirium.~      The investigators want to test the hypothesis that an Anticholinesterase Inhibitor~     (donepezil) can reduce the duration of the delirium.~   "
108690|NCT01633580|"~     The purpose of the present study is to analyse if corifollitropin alfa, an agent for~     prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day~     2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.~   "
108691|NCT01633567|"~     For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living~     in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown~     great promise in reducing health risk behaviors across a variety of behaviors and population~     groups by enhancing the relevance of the health information. The primary aim of this study~     is to test the efficacy of a culturally targeted group-based smoking cessation intervention~     (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and~     transgender (LGBT) smokers. The investigators anticipate that the culturally targeted~     intervention will be more effective at helping LGBT smokers to successfully stop smoking~     than will the non-targeted intervention.~   "
108692|NCT01633554|"~     IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33~     has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33.~     We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.~   "
108693|NCT01633541|"~     To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction~     chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for~     the treatment of advanced cancer. It is hoped that the combination of this chemotherapy~     regimen will allow cancer patients to keep their voice box and to improve/maintain~     voice-related quality of life. The ultimate goal of this study is to prevent the surgery to~     remove subjects voice box.~   "
108694|NCT01633528|"~     It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy~     rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian~     perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness~     as well, which could result in better implantation and pregnancy rates after IVF or ICSI~     treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on~     pregnancy rate following frozen embryo transfer.~   "
108695|NCT01633515|"~     A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in~     the elderly utilizing intralesional cryosurgery.~      10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo~     intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus~     the BCC is frozen. Treatment success will be determined according to biopsy results 3 months~     after treatment~   "
108696|NCT01633502|"~     Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite~     rapid invasive treatment, circulatory support using positive inotropes and mechanical~     support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new~     treatments during the last decade, the mortality in patients with cardiogenic shock still~     exceeds 50%. An alternative to current management is restoration of the volume of blood~     pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting~     this is difficult but can be done using the Impella device which is a catheter-based, axial~     flow pump that pumps blood directly from the left ventricle into the circulation thereby~     restoring blood flow to the failing organs. In 2012 a more powerful Impella has been~     introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output).~     The hypothesis of the current study is to reduce mortality and morbidity of patients with~     cardiogenic shock using the Impella cVAD. The study will be carried out as a randomized~     multicenter study where eligible patients will be randomized to receive conventional~     circulatory support or support with the Impella device and inotropic support if needed. A~     total of 360 patients are planned to be enrolled, and the primary endpoint will be death.~   "
108697|NCT01633489|"~     This is an observational, multi-center, international disease registry designed to collect~     longitudinal data and create a knowledge base that will be utilized to improve the care and~     treatment of patients with LAL Deficiency. Participation in the Registry by both physicians~     and patients is voluntary.~   "
108698|NCT01633476|"~     The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in~     ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an~     antiviral agent (valaciclovir) and whether this in turn improves the function of the immune~     system thereby also improving the body's ability to fight other infections.~      The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive~     the expansion and functional impairment of CMV-specific T-cells, with increased~     susceptibility to infection. Inhibition of CMV replication with valaciclovir will block~     further stimulation of CMV specific T-cells and increase the functional capacity of the~     immune system.~   "
108699|NCT01633463|"~     EMERGENCY CANCER PAIN DRAWS CANCER PATIENT TO EMERGENCY DEPARTMENT FOR TREATMENT. HOWEVER,~     THERE HAS BEEN INCONSISTENCY AND INADEQUACY OF PAIN MANAGEMENT IN EMERGENCY DEPARTMENT. THIS~     STUDY OBSERVES THE STATUS OF PAIN ASSESSMENT AND ITS ADEQUACY IN EMERGENCY DEPARTMENT IN A~     TERTIARY CARE CANCER HOSPITAL.~   "
108700|NCT01633450|"~     One of the newest strategies to combat micronutrient deficiencies is the biofortification of~     staple foods, where higher levels of minerals are obtained through breeding of staple crops.~     The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when~     compared with a control rice fortified with zinc just before consumption.~   "
108701|NCT01633437|"~     The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine~     after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg~     administered twice per day (BID) in healthy volunteers compared to placebo; and to~     investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at~     steady state compared to placebo.~   "
108702|NCT01633424|"~     Given the extremely limited availability of donated organs, transplant candidates must be~     carefully evaluated and selected to ensure the success of the transplant and value of the~     organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well~     established, however, listing criteria for psychosocial risk factors (e.g., understanding of~     illness and transplant process, psychiatric history, support system, compliance, etc) is~     less standardized. The purpose of this research is to study the psychometric properties~     (e.g., predictive validity) of the new pre-transplant Stanford Integrated Psychosocial~     Assessment for Transplant (SIPAT) examination in patients who received heart, kidney,~     liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new~     screening tool was designed to standardize the evaluation process of psychosocial risk~     factors and their severity, in order to enhance predictions of medical and psychosocial~     outcomes of patients post-transplant.~      If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be~     amenable to clinical intervention could be identified. In turn, this may assist in~     developing a comprehensive psychosocial treatment plan for each individual, with the~     ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft~     survival, patient function, and quality of life.~   "
108703|NCT01633411|"~     This is a feasibility study without a primary study hypothesis or statistical comparison.~   "
108704|NCT01633398|"~     The ASIAN HF Registry is the first prospective multinational Asian registry of patients with~     symptomatic HF (stage C)11 including both HFrEF (ejection fraction <40%)3 and HFpEF~     (ejection fraction ≥50%), with the broad purpose of determining the mortality (incidence)~     burden of HF in Asian patients, and more specifically to define the burden and risk factors~     of Sudden Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device~     therapy. The study further aim to study the genetic variants associated with HFrEF versus~     HFpEF in our large Asian cohort.~      This proposed registry is expected to advance fundamental understanding of the burden and~     predictors of preventable death among Asian patients with HF. The knowledge gained will be~     critical for guiding resource allocation and planning preventive strategies to address the~     unmet and growing clinical needs of patients with cardiovascular disease in Asia.~   "
108705|NCT01633385|"~     The investigators plan to study the variability of lung function parameters and bronchial~     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25~     years compared with an age- and sex-matched control group. The investigators will perform a~     pulmonary function test (body plethysmography with TLCO), and measure the fraction of~     exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic~     inflammation. Finally induced sputum is collected and a cell count is performed, and cells~     and supernatants are analyzed for inflammatory markers. This investigation will be repeated~     after 4-6 weeks. The aim of this study is to define baseline values and the variability of~     possible outcome parameters for future interventional studies.~   "
108706|NCT01633372|"~     This is a study of INCB039110 in patients with myelofibrosis. This study will evaluate~     safety and efficacy parameters of INCB039110.~   "
108707|NCT01633359|"~     Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in~     coronary artery disease (CAD) patients from those without CAD, which might account for the~     benefits of Atorvastatin in CAD patients.~   "
108708|NCT01633346|"~     The purpose of this study is to know the level of expression and activation state of~     different transcription factors of the STAT family (STAT1, STAT3, STAT5A, STAT5B, STAT6) in~     the hematopoietic cells from tocilizumab treated patients.~   "
108709|NCT01633333|"~     Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of~     colonoscopy involving the use of water as the sole modality to aid colonoscope insertion,~     water exchange, has been described in recent research papers to decrease patient discomfort~     and pain, and to reduce the need for sedation during colonoscopy when compared with standard~     air insufflation. Carbon dioxide insufflation has been described to decrease patient~     discomfort after colonoscopy. No randomized trial has so far compared the use of water~     exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less~     discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients~     undergoing screening colonoscopy in two centers in Norway, one center in Poland and one~     center in The Netherlands will be enrolled and randomized to examination of either of the~     two methods.~   "
108710|NCT01633320|"~     The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index~     (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients~     undergoing general anesthesia.~   "
108711|NCT01633307|"~     Aim: to determine whether a nationwide teaching program delivered to medical doctors can~     decrease the use of inappropriate intravenous lines in internal medicine~   "
108713|NCT01633281|"~     A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or~     thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for~     this complication include drugs like gabapentin or pregabalin, which relieve symptoms only~     partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or~     thalidomide, which may compromise treatment outcome. This clinical study explores whether,~     by intervening early in its course using acupuncture, progression of PN can be reversed,~     stabilized or retarded thereby allowing continuation of treatment on schedule.~   "
108714|NCT01633268|"~     Objective: In this study we will develop and apply imaging techniques to perform the first~     three-dimensional (3-D) measurements of brain biomechanics during mild head movement in~     healthy human subjects. Biomechanics is the application of mechanics, or the physical~     principles in action when force is applied to an object, to the anatomical structure and/or~     function of organisms. Such techniques will be invaluable for building computational models~     of brain biomechanics, understanding variability of brain biomechanics across individual~     characteristics, such as age and sex, and determining brain sub-structures at risk for~     damage when movement of the head is accelerated, such as during a traumatic event.~      Study Population: Measurements will be performed on 90 healthy men and women aged 18-50.~      Design: We will build upon the model pioneered by our collaborator, Dr. Philip Bayly. The~     model places a human subject in a magnetic resonance (MR) scanner with one of two head~     support units that allows a specific range of motion. Each head support is latched such that~     it can be released by the subject, and results in either a rotation of the head of~     approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees.~     Although both supports are weighted so that the motion is repeatable if the subject is~     relaxed, the subject can easily counteract the weight. The resulting~     acceleration/deceleration is small (in the range of normal activities, such as turning one's~     head during swimming) and has been validated and used in other human investigations of brain~     biomechanics. The subject repeats the motion multiple times during the MR scan under their~     own volition and desired pace to measure motion of the head and brain.~      Outcome measures: This project is a pilot study evaluating the potential of extracting~     three-dimensional estimates of brain deformation, such as strain measurements, using MR~     imaging. A primary outcome of this project will be a fast MR acquisition sequence for~     measuring 3-D brain deformation. The sequence will be evaluated by applying the protocol to~     human subjects, followed by preliminary quantification of the reproducibility and stability~     of deformation measurements.~   "
108715|NCT01633255|"~     Background:~      - The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment~     imaging studies. It is designed to show tumors in which new blood vessels are growing.~     Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to~     therapy that will prevent the growth of new blood vessels. Researchers will test~     [18]F-Fluciclatide before beginning treatment and after the first treatment cycle.~     Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after~     starting treatment to look for changes in blood vessel growth early after starting therapy.~      Objectives:~      - To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment~     outcomes.~      Eligibility:~      - Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor~     blood vessel growth.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor imaging studies and biopsies will be performed before~          starting the study.~        -  Participants will have two positron emission tomography (PET) and computed tomography~          (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before~          the start of cancer treatment, and the second will happen after the first treatment~          cycle.~        -  Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This~          scan will take place 2 to 7 days after beginning therapy.~        -  Depending on the location of the tumor, some participants may have an optional magnetic~          resonance imaging scan to look for changes in tumor blood flow and size. These scans~          will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.~        -  The scans will be monitored with regular blood tests and vital signs.~        -  Participants will be followed for up to 1 year after the study to look for overall~          disease response to therapy.~   "
108716|NCT01633242|"~     Background:~      - Muscular dystrophy can affect the muscles used for heart function and breathing. Treatment~     usually involves drugs that help improve heart function. However, better types of heart~     imaging studies are needed to improve treatment of heart problems related to muscular~     dystrophy. Better heart imaging methods are especially needed for children with muscular~     dystrophy. Researchers want to test different heart imaging methods in children with~     muscular dystrophy. They will look at cardiac magnetic resonance imaging (MRI) and standard~     heart function tests.~      Objectives:~      - To develop and test new methods for imaging the heart in children with muscular dystrophy.~      Eligibility:~      - Children and adolescents between 8 and 17 years of age who have muscular dystrophy.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide a blood sample at the start of the study. They will also have~          heart function tests before having the imaging study.~        -  Participants will have a cardiac MRI scan that will last up to 60 minutes. Some tests~          will require a MRI contrast agent (a drug that helps the image appear more clearly on~          the scan).~   "
108717|NCT01633229|"~     Background:~        -  Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat~          disorders that cause inflammation and immune system diseases. BMSC have been used to~          treat graft versus host disease (GVHD), a complication that can develop after stem cell~          transplants. BMSC have also been used to treat other post-transplant complications,~          like marrow failure or tissue injury.~        -  The National Institutes of Health (NIH) has developed a procedure for collecting and~          preserving BMSC from volunteer donors. These donors have passed tests to ensure that~          their cells are healthy enough to be used for treatment. Researchers want to use the~          collected cells to treat people with GVHD, marrow failure, or tissue injury following~          stem cell transplants.~      Objectives:~      - To test the safety and effectiveness of NIH-collected BMSC to treat complications from~     stem cell transplants.~      Eligibility:~        -  Individuals between 18 and 75 years of age who have complications from stem cell~          transplants.~        -  Complications are acute GVHD, poor bone marrow function, or tissue or organ damage.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have imaging studies and blood tests.~        -  Participants will provide blood, skin, and bone marrow samples before the BMSC~          treatment. Additional samples, including tissue samples, will be collected after the~          start of treatment.~        -  Participants will have up to three BMSC infusions. There will be a week between each~          infusion. Participants will be monitored closely during each infusion. Any side effects~          will be treated.~        -  Treatment will be monitored with frequent blood tests and physical exams.~        -  After the end of the infusions, participants will have regular followup visits for up~          to 2 years.~   "
108718|NCT01633216|"~     This randomized clinical trial will assess the immune response in infants following~     administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent~     OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short~     schedule with administration at two week intervals and the usual schedule at four week~     intervals. The results of this study will guide the Global Polio Eradication Program in the~     implementation of new strategies that may: 1) improve the quality of the response to~     outbreaks following importation of wild poliovirus type 1 by shortening the interval at~     which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3~     poliovirus by using bOPV in outbreak responses in countries with weak routine immunization~     systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the~     replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.~   "
108719|NCT01633203|"~     This study will assess the efficacy and toxicity of perioperative chemotherapy with~     Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of~     public hospitals in Santiago, Chile.~   "
108790|NCT01632280|"~     In this project the investigators aim to improve eating control and weight loss outcomes in~     patients undergoing LAGB with an innovative brain-based intervention. Specifically, the~     investigators will enhance the activity of the right inferior frontal gyrus, a core region~     of the brain circuit of inhibitory control, using transcranial direct current stimulation~     (tDCS).~   "
108720|NCT01633190|"~     -  Rotavirus Hospital Admissions Surveillance~        -  Retrospective surveillance for 2010 and 2011 for hospital admissions in children aged 0~          to 16 years due to rotavirus gastroenteritis will be completed by all centers of the~          IMPACT (Immunization Monitoring Program, ACTive) pediatric hospital network.~        -  Prospective surveillance of rotavirus-related admissions for children aged 0 to 16~          years was conducted in 2012-14 inclusive and will be performed for an additional three~          years, 2015, 2016 and 2017 at all 12 sites. Surveillance methodology will continue~          using the same case-finding strategy and the same case report form as in past~          surveillance (Case reporting is done electronically.~        -  Emergency Department Burden of Disease Case finding for all-cause diarrheal illness~          using ICD codes was undertaken prospectively for 2012 to 2014 and will not continue in~          the years 2015-17 inclusive. Systematic stool sampling was carried out for cases of~          gastroenteritis in children < 5 years of age presenting to the ED departments at the~          IMPACT hospitals in 2012 and 2013 and 5 of the 12 center hospitals in 2014. This~          component will not continue in to the 2015-17 protocol study years. However the~          admitted cases presenting to the IMPACT center hospitals with positive rotavirus will~          be reported and stool samples saved for genotyping at a later date.~   "
108721|NCT01633177|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical~     trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among nondiabetic participants in~     VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from~     this proposed study conducted within the VITAL trial will clarify whether vitamin D and~     omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform~     public health and clinical guidelines for diabetes prevention.~   "
108722|NCT01633164|"~     The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based~     group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which~     aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy~     intervention that delivers positive psychology concepts within a cognitive-behavioral~     therapy-based model has been created for the purpose of developing a resilient and~     optimistic sense of efficacy for people with SCI. Concepts covered within this intervention~     include: reframing and restructuring a person's method of looking at events, building~     confidence by focusing on personal strengths, developing methods of recognizing and~     appreciating the good in one's life and expressing gratitude for positive attributes. The~     goals of this intervention are to increase personal self-efficacy, enhance emotional~     well-being and improve participation in society for people with SCI living in the community.~     The investigators hypothesize that persons receiving the intervention will demonstrate~     improved SCI-specific and overall self-efficacy as compared to waitlist controls.~   "
108723|NCT01633151|"~     The purpose of the study is to determine the precision of an unobtrusive sleep measurement~     system. The system measures a force sensor signal under the mattress and analyzes sleep~     quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate,~     respiration rate, sleep related breathing disorders, and limb movements.~   "
108724|NCT01633138|"~     The purpose of this study is to investigate whether monetary reinforcement for performance~     will enhance the effects of cognitive remediation therapy for substance users seeking~     treatment at an outpatient facility.~   "
108725|NCT01633125|"~     The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs~     for appropriate treatments. Although pilot studies have suggested music therapy to be a~     successful treatment modality for prisoners, more rigorous evidence is needed.~      This study aims to investigate the effectiveness of group music therapy to improve anxiety,~     depression, and self-esteem in prisoners. One hundred and ninety two inmates from a Chinese~     prison will be allocated to two groups through randomisation. The experimental group will~     participate in biweekly group music therapy for 10 weeks (20 sessions) while the control~     group will be placed on a waitlist. Anxiety, depression and self-esteem will be measured by~     self-report scales three times: before, at the middle, and at the end of the intervention.~     Logs by prisoners and daily behavior observation by trained prison guards will be used as~     additional information.~      This study will increase the knowledge of the effectiveness of group music therapy. Results~     will be generalizable to Chinese prisons but also internationally. Generalizability to~     clinical practice will be high, and findings will be able support the further development of~     music therapy in prison.~   "
108726|NCT01633112|"~     The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to~     glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the~     treatment of patients with relapsing-remitting MS (RRMS).~   "
108727|NCT01633099|"~     The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine~     in the treatment of elderly Acute Myeloid Leukemia (AML) patients.~   "
108728|NCT01633086|"~     This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to~     be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is~     to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in~     symptom relief of subjects with painful diabetic neuropathy.~   "
108729|NCT01633073|"~     The aim of this randomized prospective study is to compare two single-use laryngeal mask~     airways with a provision of a gastric drain tube allowing for evacuation of gastric~     contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure~     ventilation. The investigators hypothesize that airway leak pressures with the i-gel will~     not be significantly different clinically (higher) when compared with the LMA Supreme.~   "
108730|NCT01633060|"~     This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective~     and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic~     breast cancer who progressed on or after mTor inhibitor based treatment.~   "
108942|NCT01630278|"~     Very premature infants with a large ductus, selected by an early echocardiogram, will~     receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated~     echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional~     age. The primary outcome will be survival without cerebral palsy at years.~   "
108731|NCT01633047|"~     The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the~     athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative~     ACL reconstruction scenario the investigator find in literature the effectiveness of~     neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the~     quadriceps muscle. The intensity of NMES and the training duration are important factors for~     a successful treatment.~      The purpose of this study is to compare two rehabilitation protocols in patients during the~     post operative of the ACL reconstruction over the strength of knee extension and control of~     edema.~      It will be a randomized controlled study with the CONSORT bases with 40 participants that~     will be divided into two groups: Control group that will be submitted only to physical~     therapy exercises, and the Intervention group that will be submitted to physical therapy~     exercises plus electrical stimulation (low frequency device with a current of 47 Hz with~     symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of~     1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention~     quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling~     through the perimeter. This procedure will be repeated after six weeks of intervention.~   "
108732|NCT01633034|"~     The purpose of the research is to collect and examine spinal disc and ligament tissues to~     see if there are any biological markers that can be correlated with MRI images to help us~     learn more about causes of back pain. Spinal discs are the pillow-like cushions between the~     bones of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the~     disc structure during movement.~   "
108733|NCT01633021|"~     Background:~      - Knowing one s family medical history is a part of staying healthy. Some health risks run~     in families, and knowing these risks can promote more healthy behavior. Different social and~     cultural factors may affect how family members share this information. Genetic risk~     information that is shared in one family may not be shared in the same way in another. This~     information may also be shared differently between spouses, siblings, or parents and~     children. It may even be shared with more distant relatives. Knowing the information that~     family members share and how they share it may help researchers improve genetic disease~     treatment and support plans. Family surveys of people who have genetic health risks may help~     provide this information.~      Objectives:~      - To study how family members affected by genetic-related diseases share health information~     with each other.~      Eligibility:~        -  Individuals at least 18 years of age who can read English or Spanish.~        -  Participants affected by a genetic disease or be related or married to someone who has~          the disease.~      Design:~        -  Participants will be screened with an initial questionnaire. They will identify their~          genetic disease and provide a basic health history.~        -  Participants who have the disease will complete an online survey or participate in a~          personal interview. The questions will take about 45 minutes to 1 hour to answer. The~          survey will ask about family health history and family support. Participants will also~          provide referrals to a spouse or relatives who will participate in the study.~        -  The spouse or relative will answer a similar survey. The survey will ask about health~          history and support for the spouse/relative with the disease.~        -  A gift card will be given as thanks for participating in the study.~   "
108734|NCT01633008|"~     Background:~        -  Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and~          significant pain. This pain can have a severe impact on a person s quality of life.~        -  Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people~          manage pain. It teaches behavioral techniques that can be used to change how people~          react to pain. ACT may help people with NF1 cope better with the pain associated with~          the disorder. Researchers want to test ACT techniques to see if they can improve coping~          in people with NF1 pain.~      Objectives:~      - To see if ACT can help treat chronic pain in adolescents and young adults who have NF1.~      Eligibility:~      - Adolescents and young adults between 12 and 21 years of age who have chronic pain~     associated with NF1.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          complete a set of questionnaires about their pain levels, quality of life, and~          medications that they are taking.~        -  Participants will take part in a training workshop for ACT. It will consist of three~          2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting~          goals that reflect personal values, and changing the focus from pain avoidance to pain~          management. There will be practice exercises between each session.~        -  At the end of the workshop, participants will receive a workbook with the exercises to~          continue to practice at home. Participants will be encouraged to spend at least 20~          minutes, three times per week, on these practice exercises.~        -  There will be a followup phone call to check on pain management after the workshop.~        -  Three months after the first study visit, participants will complete the study~          questionnaires again from home. They will provide more information about how they are~          managing their pain. The questionnaires will be returned by mail in an envelope~          provided by the study team.~   "
108735|NCT01632995|"~     This study will assess the uptake, acceptability, safety, and feasibility of HIV~     pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of~     emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually~     transmitted disease (STD) clinics and a community health center in the United States.~   "
108736|NCT01632982|"~     This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a~     mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in~     methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate~     the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention;~     and (3) a mobile-based control condition on the primary outcomes of treatment retention and~     opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic~     tool may have a tremendous impact on improving access to and effectiveness of substance~     abuse treatment in a variety of other populations (and could also be adapted for an array of~     other behavioral health applications), while significantly limiting costs.~   "
108737|NCT01632969|"~     The purpose of this study is to improve the quality of care provided for head and neck~     cancer patients. By better understanding the end of life experiences of dying patients and~     their families, the investigators hope to better anticipate and improve upon the experiences~     of future patients and their families.~   "
108738|NCT01632956|"~     There are few breast cancer support groups that focus on the specific needs of Chinese~     women. The purpose of this study is to learn about two different ways of providing support~     groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast~     cancer and its treatment. The investigators want to learn about how best to support Chinese~     women with breast cancer by providing two different types of groups: an in-person support~     group and a virtual (online/phone) support group.~   "
108739|NCT01632943|"~     This study is to evaluate efficacy and safety of renal denervation in the treatment of~     uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45~     subjects. The study will be conducted at up to 8 actively enrolling investigational sites.~     The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months~     post-procedure.~   "
108803|NCT01632111|"~     The objective of this study is to investigate whether Agalsidase alpha, a drug commonly~     prescribed in patients with Fabry disease, is associated with improvement of the pulmonary~     involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the~     surrogate markers for obstructive lung diseases are a decrease in both forced expiratory~     volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity.~     However, the measurement of these lung function parameters is indicated as yearly follow-up~     examinations with or without the treatment of Agalsidase alpha in patients with Fabry~     disease.~   "
108740|NCT01632930|"~     The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis~     of prostate cancer, the first human cancer and second leading cause of cancer death.~     Overall, in more than half of cases, prostate biopsies performed in search of a prostate~     cancer are negative. In this population, there is no consensus recommendation on how to~     care, leading to repeated invasive biopsies, potential sources of complications.~      The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the~     positivity of prostate biopsies, especially in patients who had at least one negative~     biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is~     not covered by health insurance. It is therefore essential to assess the medical and~     economic impact of its introduction into medical practice.~      The investigators propose to set up a study of high standard of proof, multicenter, based on~     recruitment of patients treated in hospitals. This working hypothesis is that the~     availability of the PCA3 test results would reduce the number of invasive biopsies performed~     incorrectly in patients already had at least one negative biopsy, thus improving the~     diagnostic strategy of prostate cancer.~   "
108741|NCT01632917|"~     The objectives of this trial are to evaluate the safety and tolerability of ATX-101~     injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.~   "
108742|NCT01632904|"~     The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects~     treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the~     percent of subjects who achieve a clinically meaningful symptom improvement (ie, total~     symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is~     also designed to demonstrate that these responses are durable with continued treatment.~   "
108743|NCT01632891|"~     The purpose of this study is to see if antiretroviral therapy (ART) is safe and works at~     getting rid of malaria in blood and to see whether one type of ART is better than another.~     This study may offer information for further research in looking at whether ART plays a role~     in the prevention and treatment of malaria.~   "
108744|NCT01632878|"~     The OPTIMISE study is a prospective, multi-center, multi-national, structured data~     collection initiative, first compiling data on the current treatment of post myocardial~     infarction patients (screening-log) and then, prospectively evaluating only those patients~     being prescribed Omacor as part of their standard secondary prevention treatment. The aim is~     to observe the Omacor cohort of patients for a period of 12 months, collecting long term~     observational data as clinical and patient-reported outcomes, especially, but not~     exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive~     Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or~     interventions will be mandated. Only results from routinely performed tests, labs,~     procedures and/or interventions will be collected if available.~   "
108745|NCT01632865|"~     To evaluate whether recanalization and stenting for symptomatic subacute and chronic~     veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent~     ischemic events and promotes functional recovery of disability.~   "
108746|NCT01632852|"~     This is a first in human, prospective, multicenter, nonrandomized, open-label,~     dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and~     immunogenicity of repeat doses of CSL362.~   "
108747|NCT01632839|"~     The primary objective of this study is the psychometric validation of two questionnaires~     (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on~     female sexual function (FSFI).~   "
108748|NCT01632826|"~     To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a~     likelihood of benefit from the pomalidomide treatment while the medication is not~     commercially available~   "
108749|NCT01632813|"~     The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the~     hypothesis that children with a congenital heart disease (CHD) show more neurocognitive~     impairment at the second follow-up at 7 years old than at the first follow-up at the age of~     4, compared to healthy controls.~   "
108750|NCT01632800|"~     This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing~     the time required for imaging. Experience has shown that unpleasant side-effects from~     magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced~     when the magnetic pulses are shortened. In this study, we will explore whether this effect~     holds true when very short magnetic pulses are applied.~   "
108751|NCT01632787|"~     Patients with acute exacerbation of chronic headache disorder present frequently to the~     Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical~     Heterophoria (VH), a poorly understood and little recognized binocular vision malady that~     when treated with realigning prismatic spectacle lenses results in marked reduction in~     headache and other associated VH symptoms.~      This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire~     (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH~     symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose~     is to determine if VH is a common cause of chronic headache disorders in ED headache~     patients.~      To achieve these goals, a prospective observational study will be performed on ED headache~     patients > 18 years old. All will be given the VHSQ, and all will be assessed for a~     diagnosis of VH by an optometrist who will utilize a novel VH testing method. High and low~     score groups on the VHSQ will then be compared to each other to determine the prevalence of~     VH in each.~   "
108752|NCT01632774|"~     Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents~     relatively rare, but potentially serious leading to death at scene in most of the cases. The~     study was undertaken to delineate mortality and its risk factors on three different levels~     (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and~     victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital~     and autopsy records.~   "
108830|NCT01631760|"~     We hypothesize that there is a statistically significant difference in miRNA profiling and~     expression of subjects with asthma upon its exacerbation compared to patient's baseline~     level or following effective treatment of an exacerbation of asthma. Therefore, plasma miRNA~     profiling may provide noninvasive, highly specific and sensitive biomarkers for asthma~     exacerbation's detection and treatment follow-up.~   "
139841|NCT01224418|"~     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid~     Arthritis patients who showed unsuccessful response against methotrexate.~   "
108753|NCT01632761|"~     The VITamin D and OmegaA-3 TriaL (VITAL; NCT01169259) is a randomized clinical trial in~     20,000 U.S. men and women studying whether taking daily dietary supplements of vitamin D3~     (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among VITAL participants and will study~     whether vitamin D or fish oil: (A) in the overall VITAL cohort, reduces the number of~     persons diagnosed with anemia and (B) in a subcohort of 900 participants seen in Boston,~     effects long-term changes of the proteins in blood in both anemic and non-anemic individuals~     who provide blood samples at the start of the study and again 2 years later.~   "
108754|NCT01632748|"~     This research is being carried out in order to compare two alternative versions of the~     Neurotech Vital Devices which have been set up to provide two different types of~     stimulation. Both these devices will be fully functioning devices and the investigators want~     to collect information on your perception of the two alternative modes. The patient will be~     asked to provide feedback on both devices which will look identical. The patient will not be~     told in which order the units were given to them until the completion of your visit.~   "
108755|NCT01632735|"~     The primary purpose of this study is to test the effectiveness of a pilot mobile based~     continuing care program (monitoring/feedback texting) relative to standard continuing care~     as usual in reducing relapse and improving psychosocial functioning outcomes in a youth~     population (under 24) with substance abuse problems.~   "
108756|NCT01632722|"~     Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have~     metastatic disease at the time of diagnosis and 50% of all patients eventually die of the~     disease. The most frequent site of colorectal metastases is the liver, which accounts for~     30% to 60% of cases. In these patients, the extent of liver disease is the main determinant~     of survival. Hepatectomy is the only potentially curative therapy for colorectal liver~     metastases (CLM), but when traditional criteria for resectability were used, only 10% of~     patients were candidates for surgical resection.~      Although adjuvant systemic therapy after resection of primary colorectal tumors is well~     established, there are relatively few data on the use of postoperative therapy vs. surgery~     alone in patients who have undergone resection of liver metastases. In this trial, the~     absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but~     significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving~     survival in patients with CLM, several studies with biologic agents have been tried. The use~     of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has~     resulted in increased response rates in patients with stage IV colorectal cancer and~     improved OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who~     were potentially curable through resection of liver metastases, perioperative treatment with~     capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of~     73% with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy~     significantly correlated with a prolonged PFS (P < .001).~      On the basis of these backgrounds, we designed a phase II study to compare the effectiveness~     of combination chemotherapy with perioperative or postoperative bevacizumab treatment in~     patients with CLM.~   "
108757|NCT01632709|"~     The purpose of this study is to see how Post Amputation Pain (PAP) affects the body and~     brain by using sensory testing (such as pinprick testing), taking pictures of your brain~     (using a functional magnetic resonance imaging (fMRI) machine) and biomedical interventions~     (such as an injection of pain medicine). All medicines and the fMRI machine used during this~     study are FDA approved. The investigators hope that by learning the causes of PAP, the~     investigators can help future amputees.~   "
108758|NCT01632696|"~     Tumor Imaging of I-124 PGN65 in Solid Tumors~   "
108759|NCT01632683|"~     This study evaluates success rates of tracheal intubation (passing a breathing tube)for~     patients who may be more challenging to intubate while utilizing one of two devices that~     facilitate placement of the tube with video technology.~   "
108760|NCT01632670|"~     The purpose of this study is to determine the effect of music therapy before, during, and~     after cardiac catheterization is associated on (a) change in reactive hyperemia index~     measured before and after catheterization using peripheral arterial tonometry and (b)~     patient stress and discomfort measured by a questionnaire, as compared to the standard of~     care (no music during cardiac catheterization).~      The hypothesis of the study is that music therapy during cardiac catheterization will be~     associated with more favorable change in reactive hyperemia and higher patient satisfaction~     compared to no music playback.~   "
108761|NCT01632657|"~     Patients with unruptured brain aneurysms and pain syndromes like trigeminal neuralgias often~     undergo minimally invasive brain surgery with a smaller incision,shorter duration of~     procedure and in some patients the possibility of going home on same day. Postoperative~     pain, nausea and vomiting are sometimes difficult to manage with conventional medications.~     This affects recovery from surgery and often delays discharge from the hospital. This study~     looks at the use of a medication called sumatriptan which is a drug that has been used in~     the treatment of migraine headaches for a very long time. This drug works on the receptors~     in the lining of the brain and around the nerves which maybe associated with pain. The~     purpose of this study is to determine if this pain medication sumatriptan given at the end~     of the surgery improves the postoperative course in terms of less pain, less nausea and~     vomiting and generally having a better postoperative quality of recovery.~      Our main hypothesis is that subcutaneous sumatriptan (6mg) administered at the end of~     surgery will improve the postoperative quality of recovery at 24 hours after elective~     minimally invasive craniotomies.~   "
108762|NCT01632644|"~     The primary objective of this study is to investigate the patient experience during skin~     biopsy.~   "
108763|NCT01632631|"~     Ongoing technological advances, especially in the field of image processing, have refined~     medical simulations to offer life-like replications of medical and surgical procedures in a~     variety of specialties. Patient-specific image data are incorporated into these simulations,~     and transformed into a 3D model. This enables the practitioner and his/her team to perform~     and practice 'real' cases on a virtual patient prior to performing the real procedure on the~     actual patient. This new technology has been referred to as 'patient-specific' rehearsal,~     also 'mission' or 'procedure' rehearsal.~      Research has already proven that simulated patient-specific rehearsal of a carotid artery~     stenting procedure may enhance surgical and team performance.~      The PROcedure rehearsal software can now also be used to practice patient-specific~     endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a~     challenging and complex procedure like EVAR may not only influence device selection based on~     preoperative planning, but also improve the technical performance of the surgeon/radiologist~     and the awareness and communication within the entire endovascular team. However, further~     research is needed to evaluate if this new technology may enhance clinical safety and~     efficiency, i.e. if patients actually benefit from physicians and team members conducting~     patient-specific rehearsals of EVAR interventions.~   "
108764|NCT01632618|"~     Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most~     frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all~     visits to physicians for LBP involve individuals over 65. In older adults, LBP has been~     associated with a host of negative consequences, including decreased physical function,~     increased fall risk, increased mood disturbance and increased health care utilization.~     Surprisingly, little research has focused on LBP in people over 65. But, recent evidence~     demonstrates that LBP is associated with increased intramuscular fat infiltration in the~     abdominal and paraspinal muscles and that this altered muscle composition increases the risk~     of mobility-related functional decline in older adults. While trunk muscle training (TMT)~     has been used in younger LBP groups, it is unproven in elders and, alone may not be~     sufficient to substantially improve function and symptoms, given the compromised state of~     ages muscle. TMT augmented with neuromuscular electrical stimulation (NMES) known to improve~     strength and function beyond the capacity of volitional exercise alone, may provide greater~     improvements. Treatment of chronic LBP in older adults using an exercise intervention has~     been hypothesized as a way to prevent functional decline and frailty progression; however~     this hypothesis has yet to be experimentally confirmed. In this exploratory study, the~     investigators will test the hypothesis that TMT plus NMES will result in reduced disability~     and pain severity compared to usual care in elders with chronic LBP.~   "
108765|NCT01632605|"~     The purpose of this study is to evaluate the safety of a daily single oral dose of sirolimus~     in patients with advanced autosomal dominant polycystic kidney disease.~   "
108766|NCT01632592|"~     Obesity is strongly associated with risk of cardiovascular disease (CVD). Data increasingly~     suggest that visceral adipose tissue (VAT) accumulation -- or increased abdominal fat -- is~     particularly deleterious to cardiovascular health, but further study is needed to test this~     idea. Increased abdominal fat may also be associated with lower secretion of a hormone~     called growth hormone (GH), which helps the body burn fat. The current study aims to~     carefully characterize relationships between abdominal fat and CVD. In addition, by using a~     medication called growth hormone releasing hormone, which is a strategy to reduce abdominal~     fat, the investigators will test the hypothesis that abdominal fat contributes uniquely to~     increased arterial inflammation.~      In the first part of this study, the investigators will investigate both lean (healthy~     weight) individuals and individuals with increased abdominal fat. The investigators will~     study their body composition, cardiovascular risk measures, insulin sensitivity, and growth~     hormone dynamics, with the hypothesis that abdominal fat, independent of general obesity,~     will be strongly associated with arterial wall thickening and atherosclerotic inflammation.~     The investigators will assess arterial wall thickness, plaque morphology, and~     atherosclerotic inflammation, and the investigators will determine associations between~     these variables and regional fat accumulation, with particular attention to abdominal fat.~      The second, treatment part of the study will be only for individuals with increased~     abdominal fat who are found to have low growth hormone secretion. In that part of the study,~     the investigators will test the effects of a growth hormone releasing hormone (GHRH)~     analogue to reduce abdominal fat and, consequently, reduce arterial inflammation. The~     investigators hypothesize that abdominal fat reduction, independent of changes in growth~     hormone, will reduce arterial inflammation and arterial wall thickness.~   "
108767|NCT01632579|"~     This is a phase I study of LY3023703 in healthy participants. The purposes of this study are~     to look at safety, how well the study drug is tolerated, how much of the study drug gets~     into the blood stream, and how long it takes the body to get rid of it when given to humans.~     Information about any side effects that may occur will also be collected. Participants will~     remain in the study for approximately 3 months. This study is for research purposes only and~     is not intended to treat any medical condition.~   "
108768|NCT01632566|"~     The purposes of this study are to look at safety, how well the study drug is tolerated, how~     much of the study drug gets into the blood stream, and how long it takes the body to get rid~     of it when given to healthy Japanese and non-Japanese participants as multiple doses. In~     addition, effects of 28-day oral dosing of LY3131207 on the amount of a cholesterol-lowering~     drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of~     it will be determined. The effects of LY3131207 after single and 28-day dosing on blood~     pressure will also be studied. Information about any side effects that may occur will be~     collected.~   "
108769|NCT01632553|"~     This study looks at the biological effect of domestic violence and abuse (DVA) on women's~     mental health. The mechanisms through which DVA causes mental disorders are very poorly~     understood. Similar to other demands, DVA activates the biological stress system, of which~     the chief component is the hypothalamic-pituitary-adrenal (HPA) axis, which produces~     chemical cortisol. Cortisol levels increase in response to short-term demand and help~     organisms deal with it by changing the processes of getting energy from food and also mental~     function. However constant activation of the HPA axis can cause damage and accelerate~     disease.~      This study tests the hypothesis that compared to non-abused women all abuse victims have~     altered diurnal rhythm in cortisol secretion and that the pattern of this alteration is~     predicted by abuse characteristics, such as its type, severity, duration, and cessation. To~     examine the hypothesis the following research questions will be addressed: 1) whether~     cortisol levels are related to mental health state; 2) whether cortisol levels are related~     to type, severity, duration and cessation of DVA; 3) whether there is any difference in~     cortisol concentrations between those women exposed to both childhood abuse and DVA and~     those who have experienced only the latter; 4) whether cortisol levels vary between women,~     living in refuge and those not living in refuge?~      To answer these research questions 214 women will be recruited in a domestic violence~     agency. Baseline and 3-monthly follow-up measures will be taken over 6 months after~     recruitment. Women will be asked to fill in a questionnaire to evaluate their demographics,~     health, experience of childhood abuse and DVA. Women's weight and height will be taken. In~     addition participants will be asked to take three saliva samples: 1st in the evening in bed,~     2nd - next morning immediately upon awakening, and the 3rd - in thirty minutes after~     awakening. Saliva will be collected by chewing (for 2 minutes) the cotton pledget provided~     with plastic tube and returned by post or via collection by the researcher. Then the saliva~     samples will be tested for cortisol and cortisone.~      Results of the study will increase our understanding of the biological mechanisms of DVA~     impact on a woman's health and tell researchers and practitioners about the possibility of~     using cortisol as an indicator to diagnose abuse-related health problems and assess~     effectiveness of medical care for abuse survivors.~   "
108770|NCT01632540|"~     This study will be a prospective observational study of real world BDP nasal aerosol users~     with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly~     online surveys regarding rhinitis control, concomitant medical conditions, concomitant~     (non-AR) medications, current AR therapy, and adverse events.~   "
108771|NCT01632527|"~     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy~     of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic~     atrophy secondary to age-related macular degeneration.~   "
108772|NCT01632514|"~     Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to~     hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency~     contributes to it. This study aims to determine the frequency of vitamin D deficiency or~     insufficiency in patients submitted to thyroidectomy, to define the risk attributed to~     vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to~     postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of~     vitamin D deficiency to prevent postoperative hypocalcemia.~   "
108852|NCT01631461|"~     The aim of this study is to investigate the prevalence of yeast and bacteria in women with~     breastfeeding pain and to identify signs and symptoms.~   "
108773|NCT01632501|"~     The freedom of choice in medicine is based on the physician's ability to treat their~     patients with the best available therapy. The armamentarium for percutaneous intervention is~     frequently determined on the basis of subjective criteria and the experience of the~     interventional cardiologist. The evaluation of devices used in coronary intervention,~     especially angiography and its clinical outcomes, has rarely been investigated; the~     exceptions are studies on stents. Therefore, the freedom of choice for the interventional~     cardiologist has been challenged, especially because of cost restrictions. This way this~     study aims to assess the safety and efficacy of a device of a single brand in performing~     percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and~     stents) in selected patients.~   "
108774|NCT01632488|"~     The study aims to:~        1. Determine whether the density of epithelial gaps in terminal ileum of patients with~          irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease~          (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).~        2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and~          visceral hypersensitivity.~   "
108775|NCT01632475|"~     This is a long term follow-up study of the open label, single-center, phase I clinical trial~     to evaluate the safety of Pneumostem® in premature infants with BPD.~   "
108776|NCT01632462|"~     Background VSL#3 has been reported as an effective adjuvant therapy both in inducing and~     maintaining remission in pediatric patients affected by Ulcerative Colitis. In addition, it~     has been shown that VSL#3 is able to modulates barrier function, intestinal permeability,~     and innate host functions, which if altered, could have a profound impact on the state of~     colitis. However it is still unclear how VSL#3-induced changes in microbial composition~     affect the status of intestinal inflammation and no study have investigated the efficacy of~     VSL#3 in the maintenance of remission in pediatric patients with Crohn's disease (CD).~      Objectives The purpose of this study will be to evaluate the effect of a probiotic~     formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability,~     microbiota, cytokines and chemokines expression in pediatric patients with CD in remission~     of disease. In addition, the efficacy of VSL#3 on the maintenance of remission will be~     assessed and the safety and the tolerability of the probiotic formula will be evaluated.~      Methods This investigation will be a prospective, multicenter, randomized, double-blind,~     placebo-controlled, cross-over trial. The study will include 50 children affected by CD in~     remission of disease, as defined by a PCDAI < 10, under treatment with Azathioprine~     associated or not to 5-ASA and will be articulated in 6 months as follows. All children will~     be randomised to a treatment group receiving for 2 months either 1-2 packet containing 900~     billion bacteria/day of VSL#3 according to their weight, and a group receiving the placebo~     drug. Assignment to therapy or placebo will be determined according to a computer-generated~     randomization scheme. At the completion of the 8 weeks, a wash-out period of 6 weeks will~     be done, when no preparation will be administered. Then each patient will be switched to the~     other group and followed likewise for further 8 weeks. All patients will continue regular~     medications throughout the study period. A group of 10 volunteer healthy children,~     comparable in age and sex, will be used as reference group for the analysis of metabolic~     profile. Patients will be assessed clinically at baseline and every 8 weeks until the~     completion of the study, at 24 weeks or at the time of relapse. At every visit data will be~     collected including patient questionnaires regarding disease activity (stool frequency,~     stool consistency, hematochezia, abdominal pain, extraintestinal manifestations of disease,~     and overall patient functioning). Additional information collected at the first visit~     included demographic data, family history, and symptom onset. Physical examination will be~     performed at each visit by a paediatrician and included an abdominal examination and~     examination for extraintestinal manifestations of CD. Routine blood tests for CD,~     cellobiose/mannitol small intestinal permeability study, stool cultures, stool calprotectin,~     will be performed at every visit and/or at the time of relapse. Urine will be collected for~     the analysis of metabolic profile with mono and bi-dimensional high-resolution 1H NMR~     spectroscopy. PCDAI and a physician's global assessment will be used to measure disease~     activity. At baseline and at 24 weeks the patients will undergo ileocolonoscopy to evaluate~     and endoscopic and histological activity of disease. Evaluation of microbiota on biopsies~     and stool samples will be performed at the time of ileocolonoscopies using Fluorescence In~     Situ Hybridization. Colon biopsies cultures will be performed in order to evaluate cytokines~     and chemokines patterns by multiplex assay. Additional data will be collected during the~     study regarding the safety and tolerability of therapy with VSL #3. Statistical analysis~     will be performed using SPSS version 15 (SPSS Inc, Chicago, Illinois, USA). Variables will~     be screened for their distribution and appropriate parametric or non parametric tests will~     be adopted as required. Cross-tabulations will be evaluated by using the Fisher test and~     χ2test. Statistical significance will be predetermined as P < 0.05.~      Expected results The investigators expect to find profound alterations in metabolic~     profiles, intestinal permeability, microbiota, cytokines and chemokine patterns of patients~     affected by CD. The administration of VSL#3 is expected to ameliorate all these alterations~     eventually identified. From a clinical point of view the effects of VSL#3 could be~     translated in prolonged clinical remission maintenance, offering a new therapeutic tool in~     the treatment of CD.~   "
108777|NCT01632449|"~     This is an single-blind, single-center, two-period crossover, PK profile study. Each subject~     will be randomized to one of two treatment sequences. Both treatment sequences will be~     enrolled concurrently.~   "
108778|NCT01632436|"~     This study will be conducted in patients with metastatic cancer and either moderate, severe,~     or no hepatic impairment who have failed other antineoplastic therapies or for whom there is~     no standard therapy. The study will be conducted in two stages. Using an existing pixantrone~     population pharmacokinetic (PPK) model, a model-based strategy will be used to evaluate the~     findings from the first stage of the study conducted in patients with moderate hepatic~     impairment and matched controls. The PPK evaluation will be completed prior to enrolling~     patients with severe hepatic impairment and additional matched controls during the second~     stage of the study. Patients with hepatic impairment will be paired with matched control~     patients with normal hepatic function, matched on gender, age, and body surface area (BSA).~   "
108779|NCT01632423|"~     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical~     practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).~   "
108780|NCT01632410|"~     The study describes the autonomic control system function in subjects post stroke in~     comparison with healthy subjects.~      Aims: To describe the Autonomic hart rate control system function in post stroke subjects in~     different rehabilitation levels in comparison with healthy subjects.~      To examine the reflective reaction of the autonomic control system as reflected in the heart~     rate variability to stimulations subjects in different rehabilitation levels in comparison~     with healthy subjects.~      To examine the autonomic control system reaction as reflected in the heart rate variability~     to physical and cognitive action subjects in different rehabilitation levels in comparison~     with healthy subjects.~   "
108781|NCT01632397|"~     Following formative work, the proposed study is an open-label, pilot, randomized, two arm~     trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a~     cognitive-behavioral based adherence intervention or health education with supportive~     counseling.~   "
108782|NCT01632384|"~     The purpose of this study is to see how the brain differs between smoking regularly and~     after not smoking for 24 hours. The investigators will be using an MRI machine to get the~     information from adult smokers and non-smokers while they lie in the scanner with their eyes~     closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after~     smoking. It is our hypothesis that brain activity will be altered after not smoking for 24~     hours.~   "
108783|NCT01632371|"~     The purpose of the study is to determine whether scoring balloon (SCB) plus~     paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis~     within limus-eluting stents (LES)~   "
108784|NCT01632358|"~     The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients~     with dyslipidemia.~   "
108785|NCT01632345|"~     Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy~     (antiretroviral activity) of 4 doses of doravirine (MK-1439) compared with efavirenz, when~     each is given in combination with TRUVADA® for at least 24 weeks in approximately 200~     participants. A single dose of doravirine will be selected for further study after all~     participants complete the Week 24 visit in Part 1. Participants receiving any dose of~     doravirine in Part 1 will be switched to the selected doravirine dose and continue in the~     study for up to 96 weeks.~      Part 2 - Selected Dose. Part 2 will be initiated after the doravirine dose has been selected~     as indicated above for Part 1. Approximately 120 additional participants will be randomized~     in 1:1 ratio to the selected dose of doravirine or efavirenz, each in combination with~     TRUVADA® for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected~     dose compared with efavirenz, particularly with regard to central nervous system adverse~     events (CNS events).~      The hypothesis tested in this study is that MK-1439 at the final dose selected is superior~     to efavirenz, each given in combination with TRUVADA®, as measured by the proportion of~     participants with CNS events by Week 8. If superiority is established at Week 8, the same~     hypothesis will be tested for Week 24.~   "
108786|NCT01632332|"~     The purpose of this study is to look at the safety and immune response to a vaccine used in~     patients previously treated for HER2 (human epidermal growth factor receptor 2) positive~     breast cancer.~   "
108787|NCT01632319|"~     The purpose of this study is to investigate the effectiveness of 2 different therapy courses~     for undergraduate college students who binge drink and experience depressive symptoms.~   "
108788|NCT01632306|"~     Purpose of this phase I/II study is to test how well LY2090314 works in combination with~     different chemotherapies in treating participants with metastatic pancreatic cancer.~   "
108789|NCT01632293|"~     The purpose is to see how multiple sclerosis (MS) is associated with strength and sensation~     using MRI, in persons with MS. The investigators will also see whether exercise can improve~     these symptoms for persons with MS.~   "
108791|NCT01632267|"~     Antidepressants are among the most widely prescribed medications, yet only 35-45% of~     patients achieve remission following an initial antidepressant trial. The financial burden~     of treatment failures in direct treatment costs, disability, decreased productivity, and~     missed work may in part derive from a mismatch between optimal, and actual, medications~     prescribed. The present one year retrospective study seeks to evaluate the indirect and~     direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in~     relation to an interpretive reporting system designed to predict antidepressant responses~     based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin~     transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.~   "
108792|NCT01632254|"~     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify~     the plaque composition and lipid content of plaques and will have the potential for repeated~     in vivo measurements. To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS~     for dimension and composition assessment of carotid artery plaques, in particularly those~     plaques with lipid rich necrotic cores. This non-invasive cross-sectional study, compares~     carotid parameters of in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology~     specimens collected at endarterectomy.~   "
108793|NCT01632241|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab~     in adult patients of black race with systemic lupus erythematosus (SLE; lupus).~   "
108794|NCT01632228|"~     This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate~     the safety and efficacy of onartuzumab in combination with bevacizumab as compared to~     bevacizumab alone in participants with recurrent glioblastoma. Participants will be~     randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus~     bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity,~     participants or physician decision to discontinue, or death.~   "
108795|NCT01632215|"~     The purpose of this study was to evaluate the postoperative analgesic effect of preoperative~     gabapentine for carpal tunnel syndrome surgery.~   "
108796|NCT01632202|"~     Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates~     opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic~     tissue while the normal tissue repair process takes place. When used in the abdominopelvic~     cavity, it has been shown to reduce the incidence of adhesions.~      The intrauterine cavity is a potential space where the walls of the uterus are collapsed~     upon itself in the normal state. It has been demonstrated that the trauma of removing a~     submucosal fibroid with electrocautery exposes the uterus to great potential for~     intrauterine adhesions since the raw charred surface is directly opposed to the opposite~     endometrial surface. Previous studies have shown that the placement of hyaluronic acid in~     the intrauterine cavity after a myomectomy is not only safe, but also decreases the~     incidence of intrauterine adhesions.~      The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine~     cavity and creating a temporary physical barrier between the walls of the uterus, that they~     will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48~     hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within~     one week, the investigators anticipate that the patient will have minimal to no discomfort;~     since no physical device is being left in the endometrial cavity, the uterus will not be~     contracting more than it does in its normal postoperative state.~   "
108797|NCT01632189|"~     This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on~     the dopaminergic system by using Positron Emission Tomography (PET) imaging with new~     radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic~     varenicline administration will increase dopamine (DA) receptors levels ([11C](+)PHNO)~     within the human brain.~   "
108798|NCT01632176|"~     This randomized controlled trial (RCT) study is a small scale test of the feasibility and~     preliminary efficacy of a brief motivational interview-style intervention. The intervention~     will take place in the pediatric and adult emergency departments by a trained~     interventionist and will follow an intervention algorithm developed by a team of dating~     abuse and brief intervention experts. The research design is as follows: the investigators~     will randomize youth ages 15-19 to one of two groups: one group who receives the~     intervention (N=~180), and the other which does not (N=~180). The investigators will compare~     changes in outcomes from baseline to 6-month follow-up for those in both groups. The~     investigators will be looking at outcomes including dating abuse-related knowledge,~     attitudes about the use of violence to resolve conflict, and dating abuse behavior~     (perpetration and/or victimization).~      Statement of study hypothesis: Youth who receive the intervention will show improvements in~     dating abuse-related knowledge, attitudes and behavior that are maintained for 6 months,~     while those in the comparison group will show no similar change.~   "
108799|NCT01632163|"~     Primary Objective:~      - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an~     add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over~     a period of 24 weeks in insufficiently controlled type 2 diabetic patients.~      Secondary Objectives:~        -  To assess the effects of lixisenatide over 24 weeks on :~             -  percentage of patients reaching HbA1c<7% or ≤6.5%,~             -  2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during~               standardized meal challenge test,~             -  fasting plasma glucose (FPG),~             -  change in 7-point self-monitored plasma glucose (SMPG) profile),~             -  body weight,~             -  change in daily basal insulin dose.~        -  To assess lixisenatide safety and tolerability.~        -  To assess anti-lixisenatide antibody development.~   "
108800|NCT01632150|"~     The purpose of this study is to determine the safety and tolerability of elotuzumab~     administered in combination with thalidomide and dexamethasone in the treatment of relapsed~     and/or refractory multiple myeloma.~   "
108801|NCT01632137|"~     The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic~     suspension in subjects with dry eye syndrome.~   "
108802|NCT01632124|"~     Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab~     in patients with rheumatoid arthritis or inflammatory myositis.~   "
109070|NCT01628601|"~     This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG)~     or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are~     prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their~     physician.~   "
108804|NCT01632098|"~     Obesity is one of the biggest public health challenges today and in the years to come,~     particularly due to its rising prevalence in children and adolescents. In addition to the~     increased health risks for each individual, obesity causes a tremendous economic burden on~     the healthcare system.~      Here, the investigators will examine the impact of extreme obesity on healthcare~     utilization, costs, and health related quality of life in adolescents. The study is a~     subproject of the Medical and psychosocial implications of adolescent extreme obesity -~     acceptance and effects of structured care study, short: Youth with Extreme obesity Study~     (YES), which aims at improving the medical care and social support structures for youth~     with obesity and extreme obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2)~     between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to~     participate. Participants will complete questionnaires to assess health related quality of~     life and utilization of healthcare. These questionnaires will be applied at baseline and~     then every 12 months (initially every 6 months) during health check-ups. As part of the~     other subprojects of YES, participants will be invited to complete further questionnaires~     and will be offered a thorough medical examination, medical care and psycho-social support.~      The investigators expect to provide valid and up-to-date information on costs and~     health-related quality of life for obese adolescents. This information will help in the~     planning of useful and cost effective preventive and therapeutic strategies, and improve the~     medical care and support structures for obese adolescents.~   "
108805|NCT01632085|"~     Reduce the risk of nosocomial transmission of germs related to the reusability of the~     laryngoscope handle. The alternative is to replace it with a disposable device, provided~     that it is as effective as the reference strategy at a reasonable cost.~   "
108806|NCT01632072|"~     The purpose of this study is to determine whether a nutrition intervention during a~     rehabilitation stay followed by nutritional advice after discharge, can improve the~     nutritional status of the patients after 3 months.~   "
108807|NCT01632059|"~     Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine~     Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as~     prognostic value.~      This study looks into ADMA as a good prognostic factor for sepsis. Further more the~     dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.~   "
108808|NCT01632046|"~     Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage~     renal disease. Unfortunately progressive alterations of the peritoneal membrane occur with~     time on PD, leading to a continuous loss of peritoneal transport function. Recently,~     double-chambered PD solutions with less Glucose Degradation Products (GDPs) and neutral pH~     have been approved for the European market. Short term administration suggests comparable~     clearance rates compared with conventional solutions. In vitro studies demonstrate an~     improved local immune defense system. To compensate for metabolic acidosis, the available~     solutions either contain lactate or bicarbonate, the impact of either buffer on long term~     acidosis control and peritoneal membrane integrity, however, is unknown.~      The prospective, European multi-center study will provide the first long term administration~     of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a~     bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end~     point will be the effect of either PD-solution on peritoneal transport characteristics (D/P~     Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base~     balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate~     parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants~     of the peritoneal transporter status and of the continued morphological transformation of~     the peritoneum will be assessed.~      After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution,~     the patients will be randomized to a 10 month study period using BicaVera and Balance,~     respectively. Dialysis regime and follow up in the out-patient clinic will be performed~     according to clinical needs (every 4 weeks); episodes of peritonitis will be treated~     according to international guidelines. Bicarbonate supplements will be prescribed at a dose~     of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be~     verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5~     ml of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after~     3, 6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test~     an intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be~     obtained at any time of abdominal surgery. Adverse events will be screened meticulously. The~     trial will be carried out in accordance with the German medicines act (AMG) and other local~     requirements, with particular reference to the ICH guidelines for Good Clinical Practice,~     and the declaration of Helsinki. At study end, the patients will decide together with the~     responsible physician which PD-fluid should be used further one.~   "
108809|NCT01632033|"~     The purpose of this study is to test the routine faisibility of a questionnaire to estimate~     walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.~   "
108810|NCT01632020|"~     The purpose of this study is to investigate the effects of short term oral Metformin therapy~     on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal~     adenocarcinoma.~      It is hypothesized that there are independent actions of Metformin on the outcome of~     subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC~     cell growth will correlate with this drug's effects on markers mentioned above, because the~     markers are closely related to tumor growth and metastases.~   "
108811|NCT01632007|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472~     in diabetic patients.~   "
108812|NCT01631994|"~     Summary:~      This study investigates the use of oral dissolving metoclopramide during standard video~     capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps~     with movement through the stomach and small bowel. This study will help us determine the~     effectiveness of oral dissolving metoclopramide on transit time through the stomach and~     small bowel of the video capsule that is ingested. This study may help with better diagnoses~     of pathology in the small bowel. Each patient enrolled in the study will either be assigned~     to a group that only ingests the capsule or the group that receives the oral dissolving~     metoclopramide plus capsule. Each patient will undergo the same standard procedures and~     precaution used during standard video capsule endoscopy. The patients that will qualify for~     the study are patients that are in need of video capsule endoscopy for further imaging of~     the small bowel. The patients must meet the inclusion criteria provided in the protocol and~     must not meet any of the exclusion criteria in the protocol. The hypothesis is that the~     patients that ingest the metoclopramide will have better capsule images and transit time and~     will allow for enhanced diagnosis of small bowel pathology.~   "
108813|NCT01631981|"~     This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo~     controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics~     of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration~     for the treatment of pain symptoms suggestive of endometriosis. The target population will~     be women of reproductive age with symptoms suggestive of endometriosis.~   "
108814|NCT01631968|"~     Prospective randomized study in cemented primary total knee arthroplasty. In one group the~     cement used was standard cement, without any antibiotics and in the other group the cement~     used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of~     cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both~     groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24~     hours in all cases. The main variable was the presence of infection according to the Center~     of Disease Control criteria with a minimum of 12 months follow-up.~   "
108815|NCT01631955|"~     Although Cystitis includes a clinical syndrome characterized by various combinations of~     dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or~     abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI~     (referred to as cystitis) has been focused microorganisms and drug-resistance. There has~     been little research on Clinical aspects on cystitis treatment such as bothersomeness, or~     the impact of symptoms on patients' quality of life (QoL). The investigators want to study~     for Assessment of UTI Symptoms and Quality of Life According to Antibiotics~     Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.~   "
108816|NCT01631942|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to~     healthy male subjects and subjects with haemophilia.~   "
109071|NCT01628588|"~     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical~     practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).~   "
108817|NCT01631929|"~     This is a randomized controlled trial comparing the time needed to get the conditions to~     space hourly controls to controls every 4 hours, using the one bag system versus the two~     bags system, in the initial treatment of children with diabetic ketoacidosis. After fast~     infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of~     maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose~     controls could determine changes in glucose IV administration. On using the classic one bag~     system each change determine a bag change. Using the two bag system allows to deliver the~     patient the appropriate glucose infusion in less time.~   "
108818|NCT01631916|"~     The purpose of this study is to determine the efficacy of addition of corticosteroid therapy~     to antibiotics in children hospitalized with community-acquired pneumonia.~      The hypothesis is that the use of corticosteroids decreases the length of stay in children~     hospitalized with community-acquired pneumonia.~   "
108819|NCT01631903|"~     The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four~     doses of vaginally administered Proellex in premenopausal women with uterine fibroids~     confirmed by ultrasound.~   "
108820|NCT01631890|"~     Consecutive patients who meet the eligibility criteria will be enrolled into the study. All~     patients with gastric varices with no history of gastric variceal bleed (Group C) will~     undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end~     of first year and at the end of study.~      The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal~     bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group~     -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound~     followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90~     patients will be enrolled and randomized into group A and Group B after resuscitation and~     urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices~     to achieve hemostasis.~   "
108821|NCT01631877|"~     After successful screening the cases of cirrhosis of liver irrespective of the etiology who~     have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will~     be recorded and the patient will be randomized into either interventional (acenocoumarol) or~     placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj.~     Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3~     monthly the Doppler screening for recanalization of portal vein thrombus will be done with~     monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will~     receive the therapy for one year irrespective of the Doppler findings in relation to portal~     vein thrombus re-canalization.Then one year drug free monitoring will be done in both the~     groups as per the primary or secondary outcome. .~   "
108822|NCT01631864|"~     This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and~     oxidative metabolism in obese hypertensive subjects.~   "
108823|NCT01631851|"~     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder~     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,~     noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also~     known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches~     children to recognize antecedents and consequences of problem behavior and to use emotion~     regulation and problem-solving skills to reduce irritability, aggression and noncompliance.~     This form of CBT has been well-studied in typically developing children with disruptive~     behavior and we are investigating if this treatment can be feasible and helpful, with~     appropriate modifications, for irritability and disruptive behavior in ASD.~   "
108824|NCT01631838|"~     The objective of this study is to address the anti-thrombotic effects of tocotrienols~     supplementation via modulation of platelet activation, thrombotic markers, inflammatory~     markers and endothelial function.~      It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress~     platelet aggregation in subjects with metabolic syndrome.~   "
108825|NCT01631825|"~     -  To investigate the safety of once-daily repeated transdermal administration of SPM 962~          within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's~          disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label~          uncontrolled study.~        -  To investigate efficacy of SPM 962 in an exploratory manner.~   "
108826|NCT01631812|"~     The primary objective of this study is to investigate safety of SPM 962 in advanced PD~     patients in a multi-center, open-label, non-controlled study following once-daily multiple~     transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54~     weeks). Efficacy is also to be exploratory investigated.~   "
108827|NCT01631799|"~     Total knee replacement is very common in Germany. After surgery patients have severe pain in~     the knee; initiation of the physiotherapy, however, is important in the first three days~     after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are~     commonly used after surgery. Both methods are used in Germany. Both methods have advantages~     and disadvantages. We wanted to answer the question which method of analgesia - after total~     knee replacement - is better concerning complications and function (after 3 months) ?~   "
108828|NCT01631786|"~     Ultrasonography is currently the most common diagnostic tool for imaging the female~     reproductive tissues. However, clinical ultrasonography is limited to the detection of~     ovarian structures ≥ 2 mm, with an inability to image microanatomy including small antral~     follicles and oocytes. The objective of this study is to determine whether the synchrotron~     can be used to effectively image bovine and human ovaries ex situ. We hypothesize that~     synchrotron imaging will provide greater resolution and thereby allow the detection of fine~     structural details of the ovary compared to conventional ultrasonography. Ovaries will be~     imaged using conventional ultrasonography, synchrotron and histology. We anticipate that our~     results will provide important information about ovarian physiology which can be applied to~     the study of female reproductive dysfunctions.~   "
108829|NCT01631773|"~     We hypothesize that the miRNA expression in subjects with nasal polyps and~     Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects~     with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).~   "
109083|NCT01628432|"~     The study compares the effect of bilateral salpingectomy associated with conservative~     hysterectomy on ovarian function to the standard hysterectomy with conservation of both~     ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications,~     quality of life.~   "
108831|NCT01631747|"~     The prevalence of maternal overweight and obesity has nearly doubled in the United States~     since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus~     23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially~     within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse~     maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically~     diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational~     weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be~     maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat)~     metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein)~     and behavioral measures (diet. physical activity, sleep and stress). In addition, babies~     will be measured for length, weight and percent body fat. The goal is to limit excessive~     gestational weight gain through improved maternal lifestyle that can be maintained and~     modelled for the family post partum and beyond.~   "
108832|NCT01631721|"~     The purpose of this study is to understand the factors that lead to adolescent sexual risk~     behavior by investigating both the family contexts and romantic relationships that influence~     adolescent couples' decision-making.~   "
108833|NCT01631708|"~     Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten~     life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to~     maintain normal iron levels. It is unclear, however, whether treatment is necessary when~     individuals have moderate elevation of iron in the body. This research project will study~     the effects of treatment in this group by assessing a number of scans, questionnaires and~     blood tests in treated and untreated individuals.~   "
108834|NCT01631695|"~     In this study, the performances of Medasense's non-invasive pain monitoring is compared with~     standard pain related indicators, such as heart rate, galvanic skin response, etc. , and~     with a subjective pain level assessment. The subjective pain level is assessed by the~     anesthesiologist when the patient is under general anesthesia and by the patient and a nurse~     in post anesthetic care unit (PACU).~      The study is based on recording and analyzing the subject's physiological signals, while~     recording painful events, medication dosing and different clinical signs.~   "
108835|NCT01631682|"~     The aim of this project is to create fear conditioning paradigm within which the relative~     strengths of various novel pharmacological and behavioral interventions can be tested. These~     interventions are intended to reduce the fearfulness associated with fear conditioning by~     blocking a memory process known as reconsolidation. In fear conditioning, a conditioned~     stimulus (CS) is paired with an aversive unconditioned stimulus (US) such as an electric~     shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR).~     The investigators hypothesize that by using a more highly prepared CS (i.e. video of~     spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional~     experimental probes for the presence of the latent CR, the investigators may develop a~     normal human paradigm that is not plagued by previously observed floor effects (i.e.~     intervention is 100% effective), within which both the established techniques of propranolol~     and delayed extinction will produce significant, but only partial, CR reduction. This would~     leave room to test and compare potentially more powerful candidate reconsolidation-blocking~     or memory-updating interventions. To achieve these aims, subjects will undergo a four-day~     fear conditioning and delayed extinction protocol. Skin conductance response data will be~     gathered across the different phases of the experiment.~   "
108836|NCT01631669|"~     Hypotheses:~      H1: Celecoxib, when given less than five days after injury will result in a statistical~     decrease in the incidence and/or severity of radiographically apparent Heterotopic~     Ossification when compared to controls.~      H2a: A biomarker profile will accurately predict which patients in the treatment group will~     respond to Celecoxib prophylaxis for Heterotopic Ossification.~      H2b: A biomarker profile will accurately predict which patients in the control group are at~     highest risk of developing Heterotopic Ossification~   "
108837|NCT01631656|"~     The purpose of this study is to compare efficacy and outcomes of treatment with azelaic acid~     (Finacea Gel) and Vascular ND:Yag laser therapy versus Vascular ND:Yag laser therapy alone~     via a split face study design in approximately ten to fifteen subjects with mild to moderate~     rosacea.~      We hypothesize that treatment of rosacea with combination azelaic acid (Finacea Gel) and~     Vascular ND:Yag laser therapy will lead to a greater improvement in lesion count, redness~     and telangiectasias compared to treatment with Vascular ND: Yag laser therapy alone.~   "
108838|NCT01631643|"~     Evaluation of the clinical benefits of One Touch VerioIQ system.~   "
108839|NCT01631630|"~     Background:~      - Drinking too much alcohol can injure cells in the body. Inflammation is the body s~     reaction to injured cells. Studies show that inflammation can cause cravings for alcohol.~     Researchers want to see if pioglitazone, a drug that decreases inflammation, can reduce~     alcohol craving. If so, it might help develop new ways to help alcoholics with craving.~      Objectives:~      - To see if pioglitazone can reduce alcohol craving.~      Eligibility:~      - Adults between 21 and 65 years of age who are alcoholic and have been drinking within the~     past month.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will also be collected.~        -  All participants will have inpatient treatment at the National Institutes of Health~          Clinical Center for the 5 weeks of the study. They will have standard treatment for~          alcoholism during their inpatient stay.~        -  Half of the people in this study will have pioglitazone. The other half will have a~          placebo.~        -  Participants will have different studies during their stay. These studies will include~          the following:~        -  Personalized audio recordings of stressful, alcohol-related, and neutral events to~          monitor mood~        -  Imaging studies to test alcohol cravings~        -  Questionnaires about mood and alcohol cravings~        -  Lumbar puncture to collect spinal fluid~        -  Inflammation test to see if the study drug can block alcohol cravings~        -  After the end of the 5-week study, all participants will be offered follow-up~          outpatient care through the Clinical Center, or referral to outside treatment.~   "
108888|NCT01630993|"~     The purpose of this pilot study is to determine if umbilical cord milking at the time of~     scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants~     as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will~     help to establish the feasibility of umbilical cord milking as an alternative to delayed~     clamping at the time of planned cesarean section.~   "
108840|NCT01631617|"~     Background:~      - Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have~     infections with S. aureus bacteria. Researchers want to study how eczema treatments affect~     the number and the type of bacteria on the skin.~      Objectives:~      - To study the effect of eczema treatments on skin bacteria.~      Eligibility:~        -  Individuals between 2 and 25 years of age who have moderate to severe atopic~          dermatitis.~        -  Healthy volunteers between 18 and 40 years of age with no history of eczema.~      Design:~        -  Participants will be screened with a physical exam and medical history. Research~          samples will be collected. Skin biopsies may also be performed.~        -  All participants will be assigned to one of several study groups.~        -  This study will last for up to 1 year. Healthy volunteers must not have taken~          antibiotics in the year before the start of the study.~        -  All participants will have regular study visits during their 1-year participation. More~          research samples will be collected at these visits.~   "
108841|NCT01631604|"~     The purpose of this study is to quantify the safety degree of the patient's gait, to detect~     the reason for the fall and quantify the biomechanical parameters related to fall. This~     study also aims to evaluate the effect of different rehabilitation treatments and their~     effect on the risk of falling.~   "
108842|NCT01631591|"~     Eosinophilic esophagitis is characterized by an eosinophilic infiltration of the esophagus.~     It presents clinically with a variety of symptoms including dysphagia, emesis, and food~     impaction. Although the underlying mechanism is different, gastroesophageal reflux can~     present with similar clinical findings but can be distinguished from eosinophilic~     esophagitis by the number of eosinophils present on esophageal biopsy. In children, food~     allergies play a role in exacerbating eosinophilic esophagitis, but the role of food~     allergies in adults is uncertain. In this study, we aim to determine the prevalence of food~     allergies in a cohort of adults with eosinophilic esophagitis.~   "
108843|NCT01631578|"~     A prospective randomized controlled trial (RCT) to determine the effect of injecting an~     autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI,~     into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.~   "
108844|NCT01631565|"~     There is recent evidence that early palliative care administered to patients helps for their~     quality of life (QoL). It is however not part of the standard multidisciplinary treatment.~      This study intents to evaluate the effect of early palliative care in patients with advanced~     Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.~   "
108845|NCT01631552|"~     The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single~     agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated~     patients with advanced epithelial cancer.The secondary objectives are to obtain initial data~     concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132~     targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is~     attached to SN38, which is the active metabolite of irinotecan. This is planned as a~     multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast~     cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up~     to 50 patients (assessable) per other cancer types included in the protocol will be studied~     at the 10 mg/kg dose.~   "
108846|NCT01631539|"~     The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded~     with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for~     wildtype KRAS unresectable liver metastases from colorectal cancer.~   "
108847|NCT01631526|"~     Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse~     clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes~     prompt vitamin D replacement problematic. This is an open, one-armed therapeutic~     intervention using a loading dose of vitamin D that will be predicted to increase plasma~     25-hydroxyvitamin D concentrations of every patient well into the normal range (> 100~     nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance~     dose. Preliminary data will also be obtained to identify potentially clinical important~     outcome benefits for future investigation. The outcomes are~        1. plasma 25OHD concentration~        2. Vitamin D binding protein and other plasma concentrations~        3. Mood and symptom~   "
108848|NCT01631513|"~     The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment~     of moderate to severe chronic pain in participants with a diagnosis of chronic low back pain~     (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone~     Controlled Release (CR), and/or morphine Sustained Release (SR).~   "
108849|NCT01631500|"~     Minor mental health problems, MMHP, like mild depression and anxiety, and medically~     unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly~     associated to each other. MMHP and MUS have an impact on well-being and quality of life,~     lead to impaired social and cognitive function and could result in reduced work capacity.~     The investigators have designed the present study as a pragmatic trial to investigate the~     effectiveness of an integrative treatment model, therapeutic acupuncture, versus~     conventional treatment in patients with MMHP or MUS in primary care. The investigators~     examined whether the effects of the integrative treatment model differed from those achieved~     with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and~     depression (assessed with the Hospital Anxiety and Depression scale), health-related quality~     of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of~     treatment interventions.~      Statistical power was calculated based on an expected 50% reduction in HAD anxiety and~     depression scores after eight weeks of integrative treatment; a 30% reduction in~     acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a~     power of 83% at p <0.05. Treatment effects were calculated as the difference between values~     at baseline, after four weeks and after the complete intervention period, i.e. after eight~     weeks. Nonparametric analyses were carried out to test differences between independent~     samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).~   "
108850|NCT01631487|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics~     of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in~     healthy Japanese adult male participants in Part 2.~   "
108851|NCT01631474|"~     CB-03-01 is being developed for the topical treatment of acne vulgaris, an~     androgen-dependent skin disorder. The purpose of this study is to compare the safety and~     efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne~     vulgaris.~   "
108853|NCT01631448|"~     Globally there have been about 45,000 kidney transplants last year. Currently, the overall~     survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major~     challenge to overcome by the renal transplant surgeons, are surgical complications which may~     impact on patient morbidity and mortality, as well as graft function.~      The aim of the study is to assess whether application of fibrin seal prevents postoperative~     complications in patients undergoing kidney transplantation.~      Controlled clinical trial with single-blind evaluation in patients surgically intervened~     kidney transplantation. It will include all patients undergoing renal transplantation in~     this Medical Center, any gender and over than 16 years and under 60 years.~   "
108854|NCT01631435|"~     This is a prospective, multi-center (up to 6 sites) study which aims to To establish the~     effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by~     visualizing the small bowel and colon in patients with active symptoms associated with~     Crohn's disease (CD).~   "
108855|NCT01631422|"~     This single-center, open-label study will investigate the pharmacokinetics and elimination~     of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers~     will receive a single oral dose of RO4602522.~   "
108856|NCT01631409|"~     This study is dedicated to determination of the long term effectiveness of coronary heart~     disease (CHD) treatments - cardiac shock wave therapy (CSWT) in comparison with other kinds~     of medical and surgical treatment. For that purpose the investigators will observe the~     patients with CHD who enrolled in this study in their routine course of treatment. But the~     investigators will not interfere with the patient treatment. Each participant will be~     followed-up for five years. The collected data will allow to determine if the particular~     method, CSWT, could really make any additional contribution to the more traditional methods~     of CHD treatment and if the CSWT is only temporarily effective or could exert the long term~     effect as well.~   "
108857|NCT01631396|"~     The study is a prospective, single center, double arm study aiming at the comparison of 2~     commercial neuromuscular block reversal drugs: Neostigmine (Cooper S.A.) and Sugammadex~     (MSD). A faster recovery from neuromuscular block is expected for patients receiving~     Sugammadex and this protocol is of high importance for anesthesia of morbid obese patients~     during bariatric surgery.~   "
108858|NCT01631383|"~     This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure~     in people who have a history of cocaine use. The subject will be admitted to the Brief Stay~     Unit (BSU), an inpatient facility at the Maryland Psychiatric Research Center, used for~     short term drug abuse or clinical trial studies. The participant will stay for 4 nights and~     5 days. He/she will be randomized to either placebo or l-THP for three days. On the morning~     of Day 4, the subject will receive one cocaine dose (40 mg intranasal) and have testing for~     pharmacokinetic parameters for the following 10 hours. The subject will stay over one more~     night and will be discharged the following day. Approximately 40 subjects will be randomized~     to enroll the target sample of 30 (N=15 placebo, N=15 l-THP). In summary, each subject will~     come for a screening visit(s), then a 5-day, 4-night stay on a secure research unit. After~     cocaine administration day, the participant will stay overnight for one more day of~     observation and to permit substantial l-THP elimination from the body. The following morning~     we will get one additional blood specimen for l-THP (Day 5 at 24 hours after last dose (7:30~     am); then the participant will be discharged. A visit with blood collection on Day 6 at 55~     hours after last dose (2:30 pm) will be scheduled. A final follow-up visit will be scheduled~     4-7 days after unit discharge to ensure no persisting side effects.~   "
108859|NCT01631370|"~     Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity~     also induces insulin resistance and it could therefore be assumed that a renal denervation~     might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in~     patients with treatment resistant essential hypertension both 1 and 3 months after renal~     denervation compared to a control group with treatment resistant essential hypertension.~     Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance~     assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation~     on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and~     to investigate the degree of insulin resistance in muscle, liver and adipose tissue.~   "
108860|NCT01631357|"~     This randomized, open-label phase II/III study is to evaluate the effects of chemotherapy~     combination with autologous cytokine-induced killer Cell immunotherapy in patients with~     stage IIIb-IV squamous non-small-cell lung cancer~   "
108861|NCT01631344|"~     Background:~      Low back pain is the leading cause of disability, affecting the quality of life and work~     productivity.~      It is the most common reason for seek medical help and advice. Low back pain creates huge~     economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically~     defined with no preferred medical treatment~        1. Study objectives:~           To prove that consulting using the Stage of change model for daily physical activity~          will lead to long term improvement of pain, disability and well-being parameters of~          those suffering from chronic low back pain, people age 25-55, when compared to~          conventional Physical Therapy.~        2. Study hypotheses:~           The intervention groups vs. Physical Therapy group will demonstrate that the following~          parameters will improve after: 3 months, one, two and five years.~             1. Pain reduction.~             2. Less disability - improvement in daily activities.~             3. Better feeling of health and well-being.~             4. Increased and better compliance to daily sport activities.~             5. BMI reduction.~             6. Reduction of cigarette smoking.~             7. Reduction of usage of anti-analgesics and anti-inflammatory medications.~             8. Reduction in number of visits to Physical Therapy clinics due to low back pain.~        3. Methods:~      The present Randomized intervention study that will include 220 healthy individuals, males~     and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or~     without radiation to the legs that were referred to Maccabi Healthcare Services Physical~     Therapy clinics in the Sharon district in Israel.~      These individuals will be randomized to one of the following two groups:~        1. Conventional Physical Therapy.~        2. Physical Therapy focused on healthy lifestyle using the Stage of Change model.~      Non-dependent observer will follow-up on the outcome parameters via phone calls and filling~     the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5~     years.~   "
108862|NCT01631331|"~     The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell~     carcinoma (BCCs) prior to surgical removal.~   "
108863|NCT01631318|"~     Patients are invited to participate in a research study of liver perfusion (how blood flows~     to the liver over time). Researchers hope to learn whether perfusion characteristics of~     liver metastases may be predictive of response to treatment and whether liver perfusion~     characteristics can be used to follow response to treatment. Patients were selected as a~     possible participant in this study because they are identified as having liver metastases~   "
108864|NCT01631305|"~     The purpose of this study is to determine whether levothyroxine is effective and safe in the~     treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive~     care unit.~   "
108865|NCT01631292|"~     In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese~     women, and hypothesize that it will not affect areal BMD, but will alter bone compartments~     (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum~     25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes~     include the influence of vitamin D and weight loss on markers of insulin resistance and on~     cognitive tests of attention, learning, and memory.~   "
108866|NCT01631279|"~     The purpose of this study is to determine the Maximum Tolerated Dose and the Dose-Limiting~     Toxicity of the drug to further evaluate safety and antitumor activity.~   "
108867|NCT01631266|"~     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      We are investigating a new skin test named C-Tb. Like the current tuberculin skin test~     (PPD), the C-Tb test is injected just under the skin and will, when positive, show redness~     and/or swelling at the injection site while a negative test will leave no reactions.~      The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are~     divided into four groups:~        -  Negative control group: Must have no history of exposure to a person with tuberculosis~          disease.~        -  Occasional contact: Must be in contact with a person with tuberculosis disease between~          6 hours/week and 6 hours/day~        -  Close contact: Must be in close contact with a person with tuberculosis disease for~          more than 6 hours/day for at least five days~        -  Positive control group: Must have a confirmed tuberculosis disease within the last 3~          years.~      The goals of this clinical trial are:~        -  To compare the C-Tb test to a blood test, the QuantiFERON test.~        -  To compare the C-Tb test to the PPD test that is currently being used.~        -  To assess the safety of the C-Tb test.~   "
108868|NCT01631253|"~     The purpose of this study is to investigate the impact on ovarian reserve after single-~     port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum~     anti mullerian hormone change.~   "
108869|NCT01631240|"~     This proposed calibration study is designed to evaluate the correlation of urinary sodium~     excretion between NHANES timed urine and 24-hour urine collections.~   "
108870|NCT01631227|"~     Aim of this study is to compare the blood pressure lowering effect of a new drug formulation~     of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used~     worldwide since years with proven efficacy. The new formulation is compared to the currently~     marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be~     demonstrated.~   "
108871|NCT01631214|"~     The purpose of this study is to determine if treatment is effective in preventing fractures~     in women with postmenopausal osteoporosis~   "
108872|NCT01631201|"~     This study will test the safety and effectiveness of an investigational antibiotic drug,~     rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This~     study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1~     gram, which will be given as a single dose to women who have genital chlamydial infection.~   "
108873|NCT01631188|"~     The study is being done to determine if the Endovent pulmonary catheter kit, used for port~     access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that~     the Endovent kit can be used effectively as a passageway for a pacing wire system.~   "
108874|NCT01631175|"~     Aim of this study is to develop and establish an indication-based algorithm for identifying~     particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic~     bone disease. A further aim was the establishment of an adequate psychosocial treatment~     within the clinical workday routine to support coping with illness and treatment.~   "
108875|NCT01631162|"~     The investigators assume that by analysis of different volatile organic compounds in the~     breath, using nanotechnology, the investigators will be able to identify a unique~     respiratory signature of different diseases including asthma, chronic obstructive pulmonary~     disease (COPD) and pulmonary hypertension.~   "
108876|NCT01631149|"~     Rationale: A deep neuromuscular block is often associated with improved surgical conditions~     especially in laparoscopic surgery. However, a deep block comes at the expense of a variety~     of items that may conflict with the use of a deep surgical muscle blockade including a long~     recovery phase, the need for muscle reversal, postoperative ventilation, impaired~     postoperative breathing. With the introduction of Sugammadex there is now the possibility to~     reverse an even deep surgical block. This may overcome most if not all of the issues~     mentioned.~      Objective: To assess whether a deep neuromuscular block provides better surgical conditions~     than a moderately deep block as derived from a surgical rating score.~      Study design: Single center, double-blind randomized controlled trial. Study population: 24~     ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery~     (n=12, GROUP 2).~      Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular~     blockade according to current practice (atracurium (bolus) plus mivacurium (cont. infusion))~     aimed at a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF)~     monitor). The other six will receive a bolus plus continuous infusion with rocuronium aimed~     at a deep neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical~     procedures will be performed by one surgeon.~      Main study parameters/endpoints: To study the surgical conditions in patients undergoing~     laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as~     assessed by the surgical rating score.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Compared to current practice there will be no additional risk.~   "
108901|NCT01630824|"~     Kidney transplantation is the treatment of choice for patients with end-stage renal disease.~     The purpose of this randomized and controlled study is to evaluate the efficacy of a~     structured education program for adult kidney transplant recipients. Patients are randomly~     assigned to an educational program or to a standard care control group. The education group~     receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney~     transplantation. Kidney transplant survival, number of rejections, infectious complications,~     length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life~     (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators~     postulate that the education group will have superior outcomes compared to the control~     group.~   "
108877|NCT01631136|"~     In France, lung cancer is responsible for more than 30000 each year. Progress was made in~     treatment of lung cancer in the last five years due to targeted therapies and to strategical~     evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of~     this strategical evolution. It is based on maintaining continuous therapeutical pression in~     order to preserve the therapeutical benefit obtained by the first line (induction~     chemotherapy). Several clinical trials showed that maintenance strategies increase the~     duration of controlled disease.~      There is two types of maintenance strategies:~        -  Continuous maintenance : prolongation of the treatment initially associated with platin~          until progression~        -  Switch maintenance : introduction of a new treatment after the end of induction~          chemotherapy~      The aim of this study is to compare two maintenance strategies~        -  A continuous maintenance by pemetrexed~        -  A switch maintenance or a continuous maintenance according to the response of induction~          chemotherapy.~   "
108878|NCT01631123|"~     This is an intervention study in healthy adult twins with the aim to investigate the genetic~     determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet~     versus an isocaloric low carbohydrate, high fat diet.~   "
108879|NCT01631110|"~     The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013~     fulfills the EMA requirements for re-registration of influenza vaccines.~   "
108880|NCT01631097|"~     This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics,~     safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees~     of hepatic impairment and normal hepatic function.~   "
108881|NCT01631084|"~     In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short)~     supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different~     sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After~     explanation by trained doctors and nurses, and with written informed consent, patients will~     be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care)~     group.~      All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter.~     Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a~     protocol based on risk stratification with predefined follow up (FU) schedules together with~     shared information and decision support (i.e. structured collaborative care). The DIAMOND~     protocol involves only baseline and yearly CA without predefined FU schedules or feedback of~     information between CA visits (i.e. usual care).~      The primary composite endpoint is all-diabetes related clinical endpoints. The secondary~     composite endpoint is attainment of treatment goals and/or control of risk factors. The~     tertiary changes are behavioral changes, psychological well being and quality of life.~   "
108882|NCT01631071|"~     The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills~     the EMA requirements for re-registration of influenza vaccines.~   "
108883|NCT01631058|"~     An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus~     low tacrolimus for the immunosuppression in renal transplantation in the elderly.~      To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this~     population.~      To evaluate whether the polymorphism of the genes that determine the expression of~     metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the~     younger population, absorption and metabolism of immunosuppressants.~      To evaluate the potential minimization of immunosuppression in this population refers to how~     does the re-population of peripheral lymphocytes, in this age group, after the use of~     lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two~     regimes.~      Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is~     the right to monitor renal function in elderly transplanted.~   "
108884|NCT01631045|"~     Scientists have studied how fasting and nutrients affect brain function in animals. The~     purpose of this study is to look at the effects of both fasting and food intake on brain~     function and memory in humans. To do this the investigators will use functional MRI to~     observe the brain and its function while fasting and after a meal. Understanding the action~     of these hormones in the brain may eventually lead to new ways to help people avoid obesity~     or lose weight.~   "
108885|NCT01631032|"~     Allergic rhinitis is a common but complicated immunologic disorder disease and multiple~     western medicine has been used for symptom control. Chinese herbal medicine, one of the most~     commonly used complementary and alternative medicine in Taiwan, has also be used for~     allergic rhinitis control. This study is designed to explore the efficacy and possible~     underlying immune-modulation effect of the BZYQT, which is one of the most famous Chinese~     herbal medicine used for allergic rhinitis in daily practice.~   "
108886|NCT01631019|"~     Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity~     and increased oxidative enzyme activity, as well as exercise tolerance in Chronic~     Obstructive Pulmonary Disease (COPD) patients.~      Design: To investigate the home-based exercise training program can reduce inflammatory~     biomarkers in COPD.~      Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang~     Gung Memorial Hospital, Taiwan.~      Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone~     assistance and 14 with free walk, were assessed for 6 months.~      Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles,~     C-reactive protein (CRP) and inflammatory cytokines.~   "
108887|NCT01631006|"~     Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of~     disability including heart failure, atrial fibrillation, and sudden death, with an annual~     mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among~     patients with established cardiovascular disease, including hypertension and atrial~     fibrillation and when present may contribute to worse cardiovascular outcome. Although~     patients with HCM do not necessarily have typical characteristics of patients with OSA, such~     as obesity and increasing age, there is recent evidence that OSA is extremely common among~     patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among~     patients with HCM is independently associated with worse structural and functional~     impairment of the heart, including atrial and aorta enlargement, worse New York Heart~     Association functional class, and worse quality of life. Therefore, the recognition and~     treatment of OSA is a new area of research that may impact in the management of patients~     with HCM.~   "
108889|NCT01630980|"~     Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts,~     pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable~     protein, and fibre, as well as minerals, vitamins, and phytonutrients. Although heart~     disease risk reduction claims for nuts have been permitted in the U.S. and general dietary~     guidelines and recommendations from heart associations recommend the consumption of nuts for~     heart protection, diabetes associations have not addressed nuts in their most recent~     recommendations. This omission is despite heart disease being a major cause of death in~     diabetes. There remains insufficient information on the usefulness of these foods in~     diabetes. To improve evidence-based guidance for tree nut recommendations, the investigators~     propose to conduct a systematic review of the effect of tree nuts on diabetes control and~     features of the metabolic syndrome. The systematic review process allows the combining of~     the results from many small studies in order to arrive at a pooled estimate, similar to a~     weighted average, of the true effect. The investigators will be able to explore whether~     eating tree nuts has different effects between men and women, in different age groups and~     background disease states, and whether or not the effect of tree nuts depends on the dose~     and background diet. The findings of this proposed knowledge synthesis will help improve the~     health of Canadians through informing diabetes association recommendations and heart~     association recommendations where they relate to diabetes.~   "
108890|NCT01630967|"~     Men with castrate resistant prostate cancer who are switched from a luteinizing~     hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in~     prostate-specific antigen (PSA).~   "
108891|NCT01630954|"~     Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400~     pregnancies in India. Although this is a benign condition , it is having the malignant~     potential too. A repeat curettage after evacuation of hydatidiform mole was generally~     advocated till 1990s. A thorough curettage at the time of initial evacuation was not~     performed because of larger size of uterus and risk of perforation. Subsequently a number of~     studies assessed the usefulness of repeat curettage and found it was unnecessary and not~     cost effective . However all these studies are retrospective in design and conducted in~     developed countries where hydatidiform mole is diagnosed earlier because of wider use of~     ultrasonography. Thus there is a need to perform a well designed prospective study to~     compare the effectiveness of single evacuation with double evacuation in treatment of~     hydatidiform mole for prevention of Gestational Trophoblastic Neoplasia.This study compares~     the effectiveness of single evacuation versus double evacuation for treatment of~     hydatidiform mole for prevention of gestational trophoblastic neoplasia .~   "
108892|NCT01630941|"~     The primary objective is to study the effect of Denosumab on Bone Mineral Density,~     Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The~     primary hypothesis is to demonstrate that Denosumab is superior to placebo.~   "
108893|NCT01630928|"~     The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is~     done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive,~     percutaneous technique where an ablation catheter is inserted through a femoral artery into~     the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia~     by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys,~     which in the Symplicity trials led to an impressive reduction of blood pressure (- 33 /-11~     mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have~     beneficial effects not only on blood pressure, but also on insulin sensitivity and~     hyperinsulinaemia.~      The investigators aim to introduce RDN as a clinical study where blood pressure reduction~     and methodical, technical aspects will be evaluated, but more importantly, also additional~     effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness,~     fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The~     investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL~     and sub-clinical organ damage.~   "
108894|NCT01630915|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×~     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by~     a washout period of 7 days.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
108895|NCT01630902|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan~     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods~     were separated by a washout period of 21 days during fasting study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
108896|NCT01630889|"~     The purpose of this open-label extension study is to evaluate long-term efficacy and safety~     of FG-4592 in maintaining hemoglobin in dialysis and non-dialysis CKD patients who have~     completed the Treatment Period of an FG-4592 FibroGen-sponsored anemia study.~   "
108897|NCT01630876|"~     This study compares the anatomical and visual outcomes of patients with idiopathic~     epiretinal membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon~     triamcinolone acetonide injection~   "
108898|NCT01630863|"~     To find the safe effective lowest light dose for photodynamic therapy (PDT). in the~     treatment of central serous chorioretinopathy.~   "
108899|NCT01630850|"~     The purpose of this study is to learn about the safety of islet transplantation for Type 1~     diabetes mellitus, which may provide more normal control of blood sugar without the need for~     insulin shots. Islets are special clusters of cells within the pancreas that produce~     insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects~     by vein.~   "
108900|NCT01630837|"~     The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of~     gingival health in patients with an adequate method of oral hygiene.~   "
108902|NCT01630811|"~     Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by~     the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8~     weeks over subjects given placebo.~      Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt~     Aggression Scale (OAS).~   "
108903|NCT01630798|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are~     very good, but if the area doesn't look different to the naked eye, then the endoscope can't~     improve on that. The investigators are looking at using special fluorescent stains in~     addition to special endoscopes designed to see abnormal areas that are not obvious to the~     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical~     laboratories but it takes several days of processing to get results. It may be very helpful~     to look for areas to sample for abnormal tissue during the endoscopy procedure.~      You are being asked to let us use fluorescent peptides with a special endoscope that allow~     us to see your esophagus with both fluorescent and white light during your upper GI~     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids~     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7~     amino acids attached to a fluorescent dye called FITC (like the one used by your eye~     doctor).~      The investigators have prepared special fluorescent peptides, that will glow when a~     special light is used that should help us separate normal tissue from abnormal tissue. In~     this study, the investigators will apply the special fluorescent peptides by a spray~     catheter to your esophagus to help us target you biopsies. Both routine and targeted~     biopsies will be taken as your endoscopist feels is indicated.~      This is a phase 1b study. This means that although the investigators have applied the~     peptide to 25 people in our first research study, the investigators still need to learn more~     about fluorescent peptide in people. The Food and Drug Administration (FDA) has not~     approved this agent, but is allowing us to test it in this study. The main goal of this~     study is to see if the peptide glows well and if the investigators can take pictures of~     the areas that do glow.~      This is a research study of the peptide and our ability to see it light up or fluoresce.~     Being in this study and applying this peptide won't change how your biopsies are taken nor~     how your endoscopy is done.~   "
108904|NCT01630785|"~     The investigators record the outcome of patients whose surgery involved intraoperative~     neurophysiological monitoring~        -  Trial with surgical intervention~   "
108905|NCT01630772|"~     The aim of this study is to evaluate the influence that has a physical therapy protocol in~     maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses~     and perinatal outcomes.~   "
108906|NCT01630759|"~     When women with diabetes become pregnant it is particularly important to control blood sugar~     levels to prevent complications. Women are advised to test their blood glucose levels seven~     times a day and to attend antenatal and diabetes clinics every 1-2 weeks throughout the~     pregnancy. For those living in rural areas in the North and West of Ireland getting to a~     hospital specialising in the management of diabetes and pregnancy on such a regular basis~     can be a challenge.~      Telemonitoring provides a possible solution to this problem by allowing patients to monitor~     their vital signs at home and transmit the information via telephone to their healthcare~     provider. If women could be safely monitored remotely for every other appointment it would~     mean that they would only need to visit the hospital once a month on a routine basis but~     with the option of attending the hospital if the remote telemonitoring indicated that this~     were necessary.~      The aim of this study is to assess the feasibility and the acceptability of using remote~     telemonitoring facilities between antenatal women with gestational diabetes and the diabetes~     team and the possibility of replacing alternate diabetic review clinics with remote~     telemonitoring. In addition this study will explore the feasibility of running a full~     randomised control trial of this topic.~      Women will be asked to monitor their blood sugar levels seven times a day which is part of~     usual care. However those in the remote telemonitoring group will be asked to measure their~     blood sugar using a meter that can transmit the results via a telephone line and to transmit~     them weekly. They will also be asked to measure their blood pressure and weight weekly and~     to download these results weekly for a health care professional to review. These results~     will be reviewed on a weekly basis by a health care professional who will contact the~     patient if necessary to discuss the results. Women will be followed-up from the date of~     diagnosis through to delivery.~      Both staff and patients will be asked to give their views on the safety and acceptability of~     remote telemonitoring through questionnaires, focus groups or interviews. The management~     decisions made on reviewing the intervention group in clinic and reviewing remote~     telemonitoring results will also be recorded. In order for remote telemonitoring to be a~     viable replacement for clinic review it must allow health care professionals to make~     comparable management decisions. Clinical data will be collected in order to provide~     descriptive statistics for those who take part and to ensure that this information could be~     collected in any future Randomised Control Trial (RCT) looking at this topic.~   "
108907|NCT01630746|"~     The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of~     TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.~   "
108908|NCT01630733|"~     The primary objective of the study is to compare overall survival of patients randomized to~     receiving custirsen in combination with docetaxel (Arm A) with patients randomized to~     receive docetaxel alone (Arm B).~   "
108909|NCT01630720|"~     There is a high prevalence of hypovitaminosis C and D in our hospital and other acute-care~     hospitals. Since the correction of these presumed deficiency states is simple, safe and~     inexpensive, their documented or suspected presence would normally be considered sufficient~     indication to correct them. However, the common practice is to ignore them. Identification~     of specific measurable medical consequences of hypovitaminosis C or D would provide a~     stronger case to treat or prevent in-hospital vitamin deficiency states.~      Biochemical deficiencies of vitamin C and D have both been linked to mood disturbance, and~     hypovitaminosis C reportedly increases blood histamine concentrations.~      We recently found that the provision of vitamin C (500 mg twice daily) but not vitamin D~     (1000 IU twice daily) promptly improved the average mood score of acutely hospitalized~     patients. We will now conduct a closely similar randomized clinical trial using a more~     adequate dose of vitamin D, namely 5000 IU/day for up to 10 days.~   "
108910|NCT01630694|"~     The purpose of this study is to identify differences in craniofacial morphology and tongue~     size between patients who have a history of difficult airway management and a control group~     of patients who had an uneventful airway management during induction of general anesthesia.~     In this study the investigators want to validate the hypothesis that there are craniofacial~     phenotypic differences between patients who have a history of difficult airway management~     and a control group of patients who have had an uneventful airway management during the~     induction of general anesthesia.~   "
108911|NCT01630681|"~     The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and~     health related quality of life in cancer patients with anxiety and depression symptoms,~     compared to Standard Care, and to evaluate the health-economic effects of the intervention.~     The investigators also want to examine the development of anxiety and depression symptoms~     and health related quality of life in cancer patients without initial symptoms.~      The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in~     relieving anxiety and depression symptoms in cancer patients, compared to Standard Care~     (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved~     health related quality of life and that I SC is cost-effective or at least cost neutral~     compared to standard care.~      The IT-platform Carebase.se is developed within U-CARE. The platform will be used for~     delivering of interventions and for collection of all patient reported outcomes. Patients~     with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale~     will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms~     will be included in descriptive studies. All patients, in the randomized controlled trial~     and the descriptive study will followed up during 24 months~      I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2).~     Step 1 starts directly after randomization and extends over a 24 months period. Step one~     comprises web-based patient education including psycho-education and easy interventions~     strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and~     a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the~     discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to~     other experts in the project group for advices about how to answer patients' questions.~      Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after~     randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for~     common psychological concerns. The participants' chooses to work with modules that~     correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and~     manualized and include conventional treatment methods with homework and weekly contacts with~     the psychologist. Step 2 extends over a 10-week period.~   "
108937|NCT01630343|"~     The Null Hypothesis is that there is no association between Pain regime and the functional~     performance among geriatric patients having traumatic hip fracture. Two limbs are being~     assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral~     Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate~     Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are~     chosen.~   "
108912|NCT01630668|"~     Background: In recent years, probiotics have shown promise in treating a variety of~     diseases. Previously, the investigators have reported on the clinical efficacy of~     Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic~     adults.~      Objective: The purpose of the study is to determine the lipid lowering efficacy of a~     One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12~     weeks in subjects with hypercholesterolemia.~      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,~     multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in~     period and a 12-week intervention period.~   "
108913|NCT01630655|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan~     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods~     were separated by a washout period of 17 days during fasting study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
108914|NCT01630642|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×~     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by~     a washout period of 7 days.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
108915|NCT01630629|"~     Changes in maternal calcium metabolism are necessary during lactation to provide adequate~     calcium in breast milk for development of the newborn skeleton. The calcium in milk is~     derived from the maternal skeleton, resulting in significant bone loss, a process thought to~     be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination~     with a decreased estrogen levels. After weaning, bone lost during lactation is rapidly~     regained.~      Differences between African-American and Caucasian bone metabolism are well documented and~     include higher bone mineral density (BMD), lower risk of fragility fracture, lower~     25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians.~     Most studies of bone metabolism in lactating women have been done in Caucasians. Because of~     differences in bone metabolism between African-Americans and Caucasians, we do not know~     whether African-Americans will have similar findings.~      The primary aim of this study is to compare the changes in bone mineral density (BMD) during~     lactation in African-Americans with those in Caucasians. It is not known whether the loss in~     BMD during lactation will be the same for both races. African-Americans display skeletal~     resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and~     lower fracture risk than Caucasians. A recent study by our group indicated that lactating~     African-American mothers had slightly lower bone resorption but quantitatively similar bone~     formation compared to Caucasians. However, there was a significant increase of 2-3 fold in~     markers of bone formation and resorption in both groups. Therefore, it is currently not~     known whether the loss in BMD during lactation will be the same for both races. Primary~     outcome measures in this study will include spine, hip and radius BMD by Dual X-Ray~     Absorbiometry (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if~     prior to 24 weeks postpartum, and six months after weaning (+1 week). This longitudinal~     protocol will distinguish between two hypotheses. Either: a) as measured by BMD, bone loss~     in African-Americans during lactation will be equal to that in Caucasians, and skeletal~     recovery will be the same or possibly accelerated compared to Caucasians; or, b)~     African-Americans will be resistant to bone loss during lactation compared to Caucasians~     because of resistance to Parathyroid Hormone-related Protein (PTHrP).~   "
108916|NCT01630616|"~     This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of~     single doses of odanacatib in mature adolescents and young adults who are currently~     receiving glucocorticoid therapy.~   "
108917|NCT01630603|"~     Objectives:~        1. To determine the incidence of vitamin D deficiency among Israeli pregnant women~        2. To access whether maternal vitamin D status affects infant bone strength.~      Methods:~        1. Vitamin D levels -in cord blood and maternal blood~        2. The mother will fill a demographic and nutritional questionnaire~           The Infants:~        3. Growth assessment of the infants: weight length and head circumference~        4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)~   "
108918|NCT01630590|"~     The goal of this clinical research study is learn if adding cabozantinib (also known as~     XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will~     also be studied.~      Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to~     grow. This may cause cancer cells to die.~   "
108919|NCT01630577|"~     We conducted this study to assess the value of early change in central venous pressure (CVP)~     in predicting fluid responsiveness in mechanically ventilated patients.~   "
108920|NCT01630564|"~     The goal of this clinical research study is to learn about the highest tolerated dose of T~     cells that can be safely given to patients whose cancer has returned after a umbilical cord~     blood transplant (UCBT).~   "
108921|NCT01630551|"~     Ocular surface disease (OSD) is a significant health problem that affects more than 10~     million persons in the United States alone. OSD is highly prevalent among medically treated~     patients with glaucoma and is associated with the number of intraocular pressure~     (IOP)-lowering medications used.~      The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty~     acid nutritional supplement in the treatment of ocular surface disease associatedwith the~     use of glaucoma eye drops~   "
108922|NCT01630538|"~     The study hypothesis is that short-term low dose cyclophosphamide therapy will be effective~     in resolving inflammation in patients with late phase antibody-mediated rejection refractory~     to current standard of care treatment.~   "
108923|NCT01630525|"~     Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia.~     Subtle executive cognitive function deficits can be detected at this early pre-dementia~     phase, more than 10 years before dementia. Among them, the digit symbol substitution task~     (DSST) has been shown to be altered very early, up to 13 years before dementia. This test,~     as many others executive function tests, requires a fine control of visuomotor coordination.~     Like executive functions, eye movements, particularly voluntary-guided saccades, are under~     the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a~     deterioration of voluntary saccades in AD using various paradigms. There are no data in~     prodromal AD, although the pathological process of the disease affects very early brain~     structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).~   "
108924|NCT01630512|"~     The purpose of this study is to determine whether mindfulness-based cognitive therapy~     (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in~     patients with diabetes.~   "
108938|NCT01630330|"~     There are multiple important factors which need to be monitored when conducting ablation for~     atrial fibrillation. The contact between the catheter tip and the inside of the heart wall~     is now measurable and may improve the effectiveness of catheter ablation for atrial~     fibrillation patients.~   "
108939|NCT01630317|"~     Slow continuous ultrafiltration using central vs peripheral line: feasibility of~     implementation, safety and efficacy in acute heart failure syndromes.~   "
108925|NCT01630499|"~     Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest~     among women with a history of breast cancer (stages 1-3) who are also overweight or obese.~     The purpose of this study is to compare a tailored nutrition, physical activity, and~     behavioral weight management program for breast cancer survivors against a widely available~     commercial weight management program. We hypothesize that an intervention tailored to the~     unique psychological, nutritional and physical needs of breast cancer survivors will provide~     superior physiological and psychological benefits compared to an existing commercial~     program.~   "
108926|NCT01630486|"~     The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney~     Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to~     10-year follow-up, and 2) to investigate the renal progression, mortality, complications,~     risk factors, role of biochemical parameters and the genetic influence.~      KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists~     and statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with~     CKD stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed~     patients or those with allograft kidney are excluded. At enrollment and at pre-specified~     intervals, laboratory tests will be conducted on the kidney function, biochemical profiles,~     anemia, cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and~     mineral bone disorder. A biobank is also established for the DNA, serum and urine at regular~     interval. Information on the medical history, health questionnaires, QoL will also be~     collected. Web-based case-report forms (CRF) is developed for the systemic management of the~     patient data.~   "
108927|NCT01630473|"~     Orthodontic therapy allows for the treatment of dental malpositions in order to produce an~     adequate relationship between teeth during occlusion. Conventional orthodontic therapy~     applies slight forces and moves teeth slowly. It is generally performed during a 2 year~     minimum of time. Recent studies seem to suggest that orthodontic therapy time can be~     shortened by surgical assistance (corticotomy). This investigation is aimed to determine the~     velocity of tooth movement and changes in periodontal clinical parameters between~     corticotomy-assisted orthodontic therapy and conventional orthodontic therapy.~   "
108928|NCT01630460|"~     CMD can be inherited in an autosomal dominant or recessive trait. CMD may also be caused by~     de novo mutations. The goal of this study is to identify genes and regulatory elements on~     chromosomes that are the cause for CMD. The investigators also study blood samples and~     tissue samples from patients to learn about the processes that lead to this disorder. The~     investigators long-term goal is to find mechanisms to slow down bone deposition in CMD~     patients.~   "
108929|NCT01630447|"~     The goal of this research study is to identify genes and regulatory elements on chromosomes~     that cause cherubism. Together with the investigators collaborators the investigators also~     study blood samples and tissue samples from patients to learn about the processes that lead~     to this disorder. The long-term goal of researchers involved in this study is to find~     mechanisms to slow down bone resorption in cherubism patients.~   "
108930|NCT01630434|"~     A prospective, international, multi-center, randomized controlled trial comparing~     preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush~     and storage (Control Group).~   "
108931|NCT01630421|"~     The goal of this research study is to identify genes and regulatory elements on chromosomes~     that cause ACC. The investigators also study tissue samples from patients to learn about the~     processes that lead to this disorder.~   "
108932|NCT01630408|"~     This is a pilot feasibility study to determine the effects of an activated vitamin D~     compound (paricalcitol) on heart structure (size) and function (ability to relax) in~     patients with normal kidney function and a form of heart failure known as HFPEF (heart~     failure and preserved ejection fraction). This study will also examine heart failure-related~     hospitalizations and changes in cardiac-stretch and biological markers that are believed to~     change along with heart size. Patients in this pilot study will be treated for a period of~     48 weeks with paricalcitol at a dose previously approved by FDA (1 mcg per day) and~     followed-up for 4 weeks after treatment is completed.~   "
108933|NCT01630395|"~     The purpose of this study is to determine if a recruitment maneuver combined with protective~     ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to~     one-lung ventilation during thoracic surgery.~   "
108934|NCT01630382|"~     The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal~     fluid congestion.~   "
108935|NCT01630369|"~     Primary Objective:~      - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2~     Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)~      Secondary Objectives:~        -  To evaluate the percentage of patients with Hb A1c < 7.5%,~        -  To evaluate the rate of hypoglycaemia (symptomatic, severe)~        -  To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb,~          Insuman Rapid after 6 month treatment~        -  To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment~        -  To assess the overall safety~        -  To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers~          after second test compare to the testing of the initial level)~   "
108936|NCT01630356|"~     This study was designed to test the hypothesis whether a novel intervention that uses~     motivational interviewing along with immediate feedback and follow-up counseling calls is~     effective in educating the household members about the health hazards of smoking and~     secondhand smoke exposure and reducing children exposure to secondhand smoke at households~     in Armenia.~      The study was a randomized control trial with two arms: intervention and control groups.~      The sample population for the study included households with a non-smoking mother and at~     least one child 2 to 6 years of age residing with at least one daily smoker. The study team~     recruited the households through pediatrician's offices in polyclinics (primary healthcare~     facilities) utilizing multistage random sampling. Trained interviewers made two baseline~     (one week apart) and two 4-month follow-up household visits to conduct measurements,~     interviews and intervention. Measurements included surveys, air nicotine monitoring in homes~     and hair samples from children to assess changes in nicotine concentration over time.~      SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge~     treated with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure~     SHS concentration at baseline and 4 month follow-up. At least one monitor was used in each~     home, preferably in the main room in which the family congregates.~      Personal exposure to SHS in 2-6 years old children was assessed using biological samples of~     hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair~     root from the back of the scalp where there is the most uniform growth pattern between~     individuals which minimizes the variability of the results.~      The intervention included an in-person counseling session with distribution of a tailored~     educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second~     baseline visit); it also included one and two months follow-up counseling calls. The control~     group received only a brief educational leaflet on the hazards of second-hand smoke~     exposure.~   "
108943|NCT01630265|"~     Previous studies demonstrate that patients often have difficulty understanding their~     discharge instructions. Video discharge instructions have the potential to mitigate factors~     such as illiteracy and limited physician time, which may affect comprehension. Our goal is~     to determine if adding video discharge instructions affects caregivers' understanding of~     their child's emergency department (ED) visit, plan and follow-up.~   "
108944|NCT01630252|"~     This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating~     the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001~     orally administered for up to 5 months with concomitant DMPA administration for the~     treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is~     open-label, the parts A2 and B are double-blind.~      The target population will be women of reproductive age and suffering from newly diagnosed~     peritoneal and/or ovarian endometriosis.~   "
108945|NCT01630239|"~     This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal~     Therapy (LITT) in the treatment of liver tumors.~   "
108946|NCT01630226|"~     This is a single center, non-randomized, open label phase II trial to evaluate the clinical~     and pathologic response of neoadjuvant cisplatin-monotherapy in BRCA1 positive patients. The~     study will enroll patients with diagnosed breast cancer with a BRCA1 mutation. Patients will~     be eligible if they have primary breast cancer (measured on mammogram and ultrasound or MRI)~     and confirmed histological diagnosis of invasive breast cancer by core biopsy. If axilla~     lymph nodes will be suspected then fine needle aspiration biopsy will be performed. Patients~     will be drawn from one of three oncology centers: Szczecin, Bielsko-Biała and Kraków.~      Patients will obtain staging investigations and will be monitored. Once entry criteria is~     met and consent obtained, all patients will obtain baseline staging investigation within 3~     weeks of trial registration. Routine investigations will include staging scans: mammography,~     ultrasound of the breast and axilla (assessment of breast tumor and axilla lymph nodes),~     assessment of chest/abdomen/pelvis (plain film, Computed Tomography [CT] and/or ultrasound~     as per local standards) and baseline blood work (Complete Blood Count [CBC], electrolytes,~     creatinine, Liver Function Tests [LFTs], calcium, albumin).~      Once staging investigations are complete, all patients will be treated with cisplatin~     chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of~     neoadjuvant chemotherapy). Clinical response will be evaluated every three weeks by the~     treating physician while on chemotherapy (tumour of the breast and axilla lymph nodes).~     After four cycles of chemotherapy the patient will then undergo definitive surgery~     (mastectomy or breast-conserving surgery). Sentinel lymph nodes procedure will be performed.~     In case of positive lymph nodes standard lymph nodes surgery will be performed. Pathological~     complete response will defined as no evidence of residual tumor in the breast and the~     axilla. There may be evidence of ductal carcinoma in situ. The pathology will reviewed by~     two independent pathologists.~      Following surgery patients will receive standard adjuvant chemotherapy at the discretion of~     the treating physician and if indicated, the patient will also receive radiotherapy and/or~     hormonal therapy and/or adjuvant trastuzumab at the description of the treating physician.~   "
108947|NCT01630213|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study (VITAL-Echo) is being conducted among participants in VITAL~     and will examine whether vitamin D compared to placebo: (1) reduces left ventricular (LV)~     mass in elderly individuals as measured with 2-dimensional echocardiography and (2) improves~     LV systolic and diastolic function as measured with tissue Doppler echocardiography.~   "
108948|NCT01630200|"~     Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory~     process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and~     mortality in COPD. Early changes of vascular integrity can be detected via markers of~     subclinical atherosclerosis.~      Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option~     in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an~     anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.~      The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor~     Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of~     systemic inflammation in the peripheral circulation of patients with stable chronic~     obstructive pulmonary disease.~   "
108949|NCT01630187|"~     The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50~     mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.~   "
108950|NCT01630174|"~     To evaluate the effect of concomitant late course accelerated hyperfractionation~     radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer~   "
108951|NCT01630161|"~     The purpose of this study is to test different ways to help cancer patients maintain their~     smoking abstinence. Participants may receive educational materials as part of the study.~   "
108952|NCT01630148|"~     The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women~     who undergo gynecologic surgery for benign conditions world wide and especially in~     developing countries including our region. Having a research in our locality for the first~     time might raise awareness of the importance of VTE prophylaxis.~   "
108953|NCT01630135|"~     Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in~     Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be~     evaluated compared with placebo.~   "
108954|NCT01630122|"~     The goal of this study is to demonstrate the feasibility of using a novel, validated panel~     of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the A/S signature) as a~     diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.~      Objectives:~        1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.~        2. To define a fixed statistical model of histologic subtype prediction in NSCLC.~      Study methods: To establish FNA biopsy requirements for gene expression-based subtype~     classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic~     studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA~     biopsy according to current standard techniques . For this part of the study, approximately~     40 biopsies of confirmed NSCLC will be collected for analysis.~      To define a fixed statistical model of histologic subtype prediction in NSCLC, we will~     prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous~     Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not~     otherwise specified (NOS), should they be encountered, may also be collected for later~     analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield~     (depending on the findings of our primary objective)will be assayed on the QGS platform.~   "
109053|NCT01628822|"~     The main objective of this protocol is to measure the improvement of the overall situation~     of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment~     relaxation.~      Secondarily,is to evaluate the evolution of physical variables, psychological and social~     improvement of the quality of life. To evaluate the evolution of drug consumption~   "
108955|NCT01630109|"~     Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to~     either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes~     prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled~     design. The outcomes to be assessed are capsule study completion rates, gastric transit~     time, small bowel transit time, and the effect of diabetes on pill capsule completion rates.~     The purpose of the study is to assess if metoclopramide given prior to pill capsule~     endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel~     transit time, and pill capsule completion rates in diabetes.~   "
108956|NCT01630096|"~     Once the lab test is positive for c. diff, the investigators will order the patient to have~     PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not~     clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for~     500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as~     well. The investigators will plan to check c. diff tests daily to see when they become~     negative. The investigators will perform chart audit/review to track mortality, the length~     of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease~     severity). Chart audit will be used to collect data on their diet and how they feel using a~     visual analog scale (collected by nursing staff daily as a standard procedure; see attached~     pain scale). Using chart audit, the investigators will record whether the patient is~     immunocompromised or not.~   "
108957|NCT01630083|"~     The purpose of the trial is to assess the therapeutic effects and the safety profile of~     IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment~     for patients with advanced adenocarcinoma of the stomach, the esophagus or the~     gastroesophageal junction compared to EOX alone.~      Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral~     activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical~     efficacy threshold will be investigated.~   "
108958|NCT01630070|"~     The objective of this clinical study is to evaluate the immediate and long-term (up to 12~     month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the~     treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot~     ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally~     50mm long.~   "
108959|NCT01630057|"~     An open-label, randomized, multi-centre, superiority study to assess that, in patients who~     respond to zonisamide added as third drug after failure of a two-drug combination therapy,~     the triple therapy is superior to the conversion to a double therapy including zonisamide.~   "
108960|NCT01630044|"~     This is a prospective, non-randomized and unblinded study designed to generate preliminary~     data to assess the effect of a new portable non-invasive brainstem stimulator to treat~     migraine headaches in patients with episodic migraine headaches.~   "
108961|NCT01630031|"~     Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial~     fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due~     to PVs reconnection. In this setting, all procedural means able to improve the quality of~     tissue lesions are welcome.~      Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a~     new catheter available on the market, was a valuable additional tool increasing the efficacy~     of the ablation procedure for PVI.~      Methods - Prospective observational non-randomized monocentric study. Patients with~     paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter~     ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF~     ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH~     Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF~     or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60~     consecutive patients are enrolled in the study, with 30 patients in each group. All~     procedures is performed by the same experienced operator, not blinded to the catheter used.~     Except for CF information (with an objective of at least 10 g, associated to the most~     perpendicular vector obtainable), ablation procedures are carried out using identical~     approaches in both groups. Patients are discharged from hospital free of antiarrhythmic~     therapy. Patients are enrolled in a specific follow-up plan.~      Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion~     of patients free of AF after 12-month follow-up.~   "
108962|NCT01630018|"~     The purpose of this study is to determine the efficacy and safety of belotecan or topotecan~     in patients with recurrent or refractory ovarian cancer (AOC).~   "
108963|NCT01630005|"~     Strokes are the first cause of acquired physical disability among adults. Some studies~     proved that depression is often an unrecognized complication from stroke, associated with a~     vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the~     hypothesis of the existence of a particular psychological state after stroke particularly~     favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to~     estimate the feasibility of a talk therapy and its impact on the anxio-depressive~     symptomatology after stroke.~   "
108964|NCT01629992|"~     The investigators examined whether a written plus verbal preoperative counseling for~     patients undergoing open cholecystectomy would improve perioperative symptoms such as~     nausea, vomiting and pain.~   "
108965|NCT01629979|"~     The effects of treatment of transplantation of harvested autologous epidermal cells on~     vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled~     study.~   "
108966|NCT01629966|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone~     relative to placebo in the treatment of generalized anxiety disorder (GAD)~   "
108967|NCT01629953|"~     This study continues to develop and refine best practices in the delivery of vocational~     services to veterans with histories of felony convictions and mental health/substance abuse~     difficulties. There are currently over 225,000 incarcerated veterans and it is estimated~     64,000 veterans are released from prisons annually. These veterans encounter significant~     difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated~     work skills. Additionally these veterans are more likely to be homeless than other~     population., Previous work has found that manual based, vocational groups led by trained~     vocational staff led to quicker employment compared to traditional vocational services and~     manual based self studies. To attempt to improve on previous results, this study adds~     principles and components of supported employment including ongoing follow-up, treatment~     team coordination, and community based assistance.~   "
108968|NCT01629940|"~     The investigators propose to obtain facial photographs for use in testing a computer~     algorithm that recognizes males at high risk for Hypohidrotic Ectodermal Dysplasia (XLHED).~     FDNA (www.fdna.com), a software company with expertise in the area of facial recognition, is~     collaborating with the Sponsor in algorithm development based on 2D photographs not~     requiring special photographic technologies. A frontal facial photograph will be taken at~     the time of study conduct. The anonymized photographs will be transmitted to FDNA for~     analysis. A limited number of unaffected controls will be also be recruited.~      A subset of affected males between ages 5 and 25 years will have the option of having a~     blood draw for a set of laboratory studies assessing nutritional status.~   "
108969|NCT01629927|"~     The study proposes to enroll male subjects affected by Hypohidrotic Ectodermal Dysplasia~     (XLHED). The sweat duct images will be acquired with a CE marked skin-imaging device and the~     sweat rate will be measured using a CE marked pilocarpine iontophoresis and collection~     system. The technologies for both imaging of sweat ducts and the measurement of maximal~     sweat rate have been used safely and without adverse events in our prior studies involving~     HED/XLHED subjects. Furthermore, this study will assess the feasibility of developing a~     non-invasive screening tool that will enable detection of clinical signs of XLHED based on~     an analysis of a two dimensional frontal photograph.~   "
108970|NCT01629914|"~     The main purpose of this study is to evaluate changes in brain functioning using an MRI~     machine following mindfulness meditation training.~   "
108971|NCT01629901|"~     This is a prospective, non-randomized study designed to generate preliminary data to assess~     the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral~     blood flow on normal healthy volunteers.~   "
108972|NCT01629888|"~     The purpose of this study is to investigate the safety of consumption of three times the~     standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.~   "
108973|NCT01629875|"~     The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox~     in moderate to severe glabellar line patients.~   "
108974|NCT01629862|"~     The investigators will examine the possible synergistic effects of obstructive sleep apnea~     (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part~     investigation:~        -  A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy~          controls.~        -  A three-month randomized placebo-controlled trial of continuous positive airway~          pressure (CPAP) in subjects with OSA+DM.~   "
108975|NCT01629849|"~     To investigate safety, tolerability, pharmacokinetics including posology, and~     pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic~     subjects~   "
108976|NCT01629823|"~     The CPAP trial is a 3-arm parallel design randomized sham-controlled trial. Participants are~     randomly assigned in equal allocation to one of three treatments: CPAP 10 cm H2O (high) vs.~     CPAP 5 cm H2O (medium) vs. CPAP Sham (less than 1 cm H2O, Low). The treatment period is 12~     weeks with airways reactivity assessed at baseline, 6 and 12 weeks of treatment and after a~     2 week washout.~   "
108977|NCT01629810|"~     The purpose of this study is to test the effectiveness of whole body periodic acceleration~     for helping with symptoms of aches and pains suffered by many patients.~   "
108978|NCT01629797|"~     Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of~     the hair follicle, associated with oil production. It is found across skin types and is~     present in 85% of adolescents, representing a large affected population. Because of the~     universal nature of the disease, 36.3% of acne patients come from backgrounds other than~     Caucasian.~      The purpose of this study is to examine patient knowledge about acne in different~     populations and to assess the effectiveness of a teaching intervention on acne knowledge.~     The investigators aim is to better understand and subsequently reduce any potential health~     disparities within the minority populations.~      This project will evaluate differences in acne knowledge between different ethnic groups,~     and the efficacy of an educational intervention. Subjects will first complete a survey~     evaluating their knowledge of acne and how acne affects them psychosocially before an~     educational intervention. Immediately following the intervention, the patient's knowledge of~     acne will be evaluated again. Finally, two months after the intervention, a phone call will~     be made evaluating their retention of the education materials and their quality of life~     related to psychosocial effects of acne. Investigating this educational intervention and any~     current disparities in acne education and understanding will better allow us to educate and~     treat acne patients in the future.~   "
108979|NCT01629784|"~     Studies have shown that there are significant differences in severity and outcome of lupus~     in patients of colored skin compared with Caucasians. There are many factors that lead to~     this discrepancy: genetics, poverty, education level, as well as behavioral and cultural~     factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with~     identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The~     investigators hypothesize that there are disparities in knowledge about photoprotection,~     leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of~     risk factors and triggers, especially sun exposure, and the effects on quality of life of~     Caucasian and minority populations, by conducting an assessment survey and subsequent~     teaching intervention on appropriate skin protection techniques including appropriate sun~     screen application, and use of sun-protective clothing. After three months a survey to~     evaluate knowledge retention about and the application of the educational intervention will~     be conducted.~   "
108994|NCT01629589|"~     The aim of this study is to describe immunogenicity of a single booster dose of Adacel~     vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.~      Primary objective:~        -  To describe seroprotection rates against tetanus and diphtheria in subjects randomized~          to receive either Adacel or Boostrix vaccine.~      Observational objectives:~        -  To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean~          antibody concentrations (GMCs) in subjects randomized to receive either Adacel or~          Boostrix vaccine.~        -  To describe booster response rates against tetanus, diphtheria, and pertussis in~          subjects randomized to receive either Adacel or Boostrix vaccine.~        -  To describe the rates of adverse events (AEs) immediately post-vaccination, and the~          rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with~          Adacel or Boostrix vaccine from Visit 1 through Visit 2.~   "
108995|NCT01629576|"~     Investigate whether economic incentives help obese individuals to lose weight.~   "
108980|NCT01629771|"~     According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic~     disease, is the second leading cause of disability worldwide. Across 81 countries,~     approximately 120 million people are infected with the disease, and of those infected, an~     estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis,~     elephantiasis and lymphedema, cause long-term suffering in patients who are then often~     embarrassed or even rejected from their communities. Because of the disease's debilitating~     physical and social effects on patients, this study will explore the intersection of~     disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in~     India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and~     gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology~     Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group~     in India will be used to gauge HRQol. In addition, the demographic and disease-specific~     factors associated with HRQoL and disability in filarial lymphedema subjects will be~     identified.~   "
108981|NCT01629758|"~     The purpose of this study is to determine whether the combination of the 2 drugs being~     investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the~     clinical benefits of two different schedules of the combination.~   "
108982|NCT01629745|"~     RATIONALE: Testing for minimal residual disease in blood samples from patients with acute~     lymphoblastic leukemia may help doctors plan better treatment.~      PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in~     samples from younger patients registered on COG-AALL08B1 trial.~   "
108983|NCT01629732|"~     The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir~     (DCV) when given in combination with or without Ribavirin~   "
108984|NCT01629719|"~     Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the~     efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as~     a contrast X-ray (X-ray).~   "
108985|NCT01629706|"~     The purpose of the study is to investigate the corneal epithelial cell response associated~     with lens wear that results in solution-induced corneal staining (Phase1) and to determine~     the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).~   "
108986|NCT01629693|"~     The purpose of this study is to evaluate differences in the comfort at the end of the month~     between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft~     contact lens wearers.~   "
108987|NCT01629680|"~     A number of common eye diseases such as age-related macular degeneration and glaucoma are~     associated with ocular perfusion abnormalities. Although this is well recognized there is~     not much possibility to improve blood flow to the posterior pole of the eye in these~     diseases.~      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the~     brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the~     drug, but also on the rheological properties of red blood cells. In two recent studies the~     investigators have shown that intravenous moxaverine increases choroidal and retrobulbar~     blood flow in healthy young subjects, in elderly people with healthy eyes and in patients~     with eye diseases associated with hypoperfusion. The present study aims to investigate,~     whether ocular blood flow is also improved after oral administration of moxaverine.~   "
108988|NCT01629667|"~     To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary~     function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a~     chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.~   "
108989|NCT01629654|"~     Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke~     fatigue is related to poor neurological recovery, low level of activities of daily living,~     decreased quality of life and may possibly affect the ability to return to work. Little is~     known about strategies addressing post-stroke fatigue and their effectiveness.~      Aim: to develop, test and evaluate a health promotion program based on strategies addressing~     poststroke fatigue.~   "
108990|NCT01629641|"~     The purpose of this study is to determine the test-retest and inter-rater reliability and~     concurrent validity of two iPhone goniometric applications in the measurement of active~     shoulder external rotation as compared to a standard manual goniometer. The scientific~     hypotheses for this study are as follows:~        1. There will be significant Pearson correlations (>.8) to demonstrate test-retest~          reliability for each of the tools between the 1st and 2nd round of testing as assessed~          by novice testers.~        2. There will be significant intra-class correlation coefficients (>.8) to demonstrate~          inter-rater reliability between the novice tester and the experienced tester for each~          of the three tools.~        3. There will be significant Pearson correlations (>.8) to demonstrate concurrent validity~          between the standard goniometer and the photo capture application, the standard~          goniometer and the accelerometer-based application and the photo capture application~          with the accelerometer-based app. as assessed by novice testers.~   "
108991|NCT01629628|"~     This study will be a prospective, open label, randomized, comparative study. Comparing the~     efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in~     maintaining remission of post-operative CD patients, with a high risk of disease recurrence.~      Patient assessment for efficacy will be conducted through interval endoscopic surveillance~     at 24 and 52 weeks.~      Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be~     re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude~     therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.~      The investigators expect a substantial increase in both endoscopic, as well as clinical~     remission rate in patients on adalimumab therapy.~   "
108992|NCT01629615|"~     The purpose of this study is to evaluate the clinical activity of BKM120 in patients with~     metastatic triple-negative breast cancer.~   "
108993|NCT01629602|"~     Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory~     loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be~     a challenge problem. To resolve this problem, we combined the nerve branch with the~     boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward~     areas. For comparison, we also collected a consecutive series of 32 patients with similar~     injury in the finger treated using a cross finger flap and a secondary free nerve graft.~   "
108996|NCT01629563|"~     This is a Phase III, multicentre, randomized, double-blind, parallel group, long-term study~     investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment~     of uterine myoma. The target population is composed of pre-menopausal women with symptomatic~     uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to~     assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or~     10mg doses on uterine bleeding, myoma size, pain and quality of life.~   "
108997|NCT01629550|"~     Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them~     are avoidable and can be prevent by improving aseptic practices during catheter insertion~     and maintenance. Indeed, the main route of catheter contamination for short-term catheters~     is the insertion site. Consequently, the quality of skin disinfection is the most effective~     preventive measure to reduce the incidence of these infections.~      This aim of the present study is to compare four strategies of skin disinfection to~     determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic~     povidone iodine in reducing catheter infection and to assess whether a detersion phase prior~     to disinfection reduces catheter colonization as compared with no detersion.~   "
108998|NCT01629537|"~     Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or~     impairment in social, occupational or other important aspects of functioning. The occurrence~     of PTSD in the military is on the rise. This has significantly impacted military members,~     their families, and society as a whole. According to an expert panel convened by the~     Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies~     is low. Safe and effective treatments are urgently needed. The specific aim of this~     investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms,~     utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with~     local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be~     recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention~     for PTSD treatment. Participants will be randomized to receive either the SGB with local~     anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to~     the neck. The PTSD symptoms before and after the procedure will be measured using a~     comprehensive clinician-administered scale, self-report measures, objective measures of~     cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment~     prior to the procedure, one week following the procedure, one month and 3 months following~     the procedure. Patients receiving sham injections will be allowed to cross over to the~     treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et~     al from Walter Reed Medical Center, who utilized this technique to successfully treat~     soldiers with combat-related PTSD, we predict that the use of Stellate Ganglion Block will~     result in reduction of PTSD symptoms as measured by clinician-administered scales,~     self-report measures, objective measures of cognitive ability, and physiologic reactivity~     measures, leading to a significant and lasting reduction of PTSD symptoms.~   "
108999|NCT01629524|"~     Hypothesis of this study is that increased immunity of primary tumor affects the increased~     number of lymph node retrieved. This study investigates whether immunity-related cytokine~     expression on primary tumor, colonic mucosa, and serum is associated with the number of~     lymph node retrieved in colorectal cancer patients.~   "
109000|NCT01629511|"~     The goal of this clinical research study is to learn the highest tolerable dose of~     gemcitabine (out of 4 possible doses) that can be given in combination with busulfan and~     clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if~     this combination can help to control CLL. The safety of this treatment will also be studied.~      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer~     cells to die. It is commonly used in stem cell transplants.~      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may~     cause the cancer cells to die.~   "
109001|NCT01629498|"~     The goal of this clinical research study is to learn if the dose of radiation to the tumor~     but not the surrounding healthy tissue could be increased by using intensity-modulated~     photon therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).~      In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT~     that can be given to the tumor.~      In Phase II, researchers want to learn if IMPT can help to control the disease compared with~     standard proton therapy when both are combined with standard chemotherapy. Participants will~     also receive standard chemotherapy. Proton therapy and photon therapy are types of radiation~     therapy that are designed to use a beam of proton or photon particles (similar to getting an~     x-ray) to send radiation inside the body to the tumor.~      In IMPT and IMRT, the amount or strength of the protons or photons will be adjusted~     according to the size, shape, and thickness of the tumor. In this study, the tumor will~     receive a higher dose by adjusting the energy and scanning time of the protons or photons,~     which is called simultaneous integrated boost (SIB). The treatment will be done with image~     guidance. This newer type of radiation is designed to give a higher than standard dose of~     treatment to the tumor. It is also designed to focus the treatment on the tumor to avoid~     affecting the healthy tissue around the tumor as much as standard treatments.~   "
109002|NCT01629485|"~     The investigators will perform a randomized controlled trial with a stratified-block design~     to compare the effect of the part versus whole task simulation training for TEP repairs.~   "
109003|NCT01629472|"~     There is some evidence that suggests that economic empowerment and challenging gender~     inequalities and prevailing ideas on masculinities will lead to a decrease in levels of~     partner violence. However, there is still a gap in our understanding of what elements are~     required. This project evaluates whether participation within a savings group and a~     discussion group confronting gender norms will lead to an increase in women's individual~     agency and decision-making ability that will improve their economic independence and~     decrease intimate partner violence in their homes.~   "
109004|NCT01629459|"~     Barth syndrome (BTHS) is a disorder that is characterized by heart failure, exercise~     intolerance and skeletal muscle weakness. Preliminary evidence demonstrates that endurance~     exercise training does not significantly improve exercise tolerance in BTHS. Because~     endurance exercise training targets a metabolic pathway that is adversely affected by BTHS,~     the investigators hypothesized that resistance training may improve exercise tolerance in~     BTHS because this type of training targets a different metabolic pathway than does endurance~     exercise. Therefore, the overall objective of the pilot/feasibility/proof-of-concept~     proposal is to collect preliminary data on the following hypothesis: Supervised resistance~     exercise training (3x/wk, 45min, 12 wks) will improve exercise tolerance, heart function,~     muscle strength and quality of life, and will be found safe in adolescents and young adults~     with BTHS.~   "
109022|NCT01629225|"~     The purpose of this study is to investigate the association between GRK4 polymorphisms and~     essential hypertension in southwestern Han Chinese and test whether these polymorphisms were~     associated with the changes in blood pressure in patients with essential hypertension~     treated with angiotensin II Type antagonist candesartan.~   "
109005|NCT01629446|"~     The purpose of this study is to see how lofexidine (investigational study formulation drug)~     is absorbed, broken down, and removed from the body. To do this, a special form of the study~     drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces~     samples will be collected at different times to measure the amount of the study drug and~     radioactivity they contain. The amount of radioactivity you will be exposed to is less than~     the amount of radiation from a regular X-ray.~   "
109006|NCT01629433|"~     In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment~     option for overactive bladder symptoms in patients affected by either neurogenic and~     idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves~     overactive bladder symptoms in neurologic patients has been only partially investigated.Some~     evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking~     detrusor muscle cholinergic innervation. However, recent experimental observations indicated~     that onab/A determines more complex effects on bladder activity acting on afferent~     innervations as well as on the efferent one. Only few experimental studies have investigated~     the activity of onab/A on bladder afferent nervous transmission. Experimental studies in~     animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO.~     Although there are some evidence on the ability of onab/A to improve DO and to reduce~     bladder and urinary content of NGF, how onab/A influences NGF expression and the expression~     of TrKa, p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF~     bladder tissue levels and in the same time it modulates the gene expression of NGF~     associated receptors (TrkA, p75 and TRPV1).~   "
109007|NCT01629420|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients~     with endometriosis.~   "
109008|NCT01629407|"~     This is an epidemiological, non-interventional, prospective study to collect data on~     glaucoma progression in a routine setting. Patients may receive treatment at the discretion~     of their physician per local standard of care.~   "
109009|NCT01629394|"~     Postoperative residual curarization in the post anaesthesia unit has been associated to~     complications involving respiratory function and impaired laryngeal and pharyngeal muscles'~     function. Speed of reversal of neuromuscular blockade after administration of sugammadex~     versus neostigmine has been studied, but up to date no data are available concerning~     continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in~     morbidly obese patients undergoing weight loss surgery. The investigators' aim in this~     prospective, double-blinded study was to compare train of four ( TOF ) values, the presence~     or absence of clinical criteria of postoperative residual curarization , the dose~     requirements and the side effects of sugammadex and neostigmine for the reversal of~     rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open~     surgery for morbid obesity.~   "
109010|NCT01629381|"~     Study Objective: To assess the value of Rivaroxaban for the prevention of venous~     thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of~     reference.~      Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of~     the type and duration of the procedure, will be eligible for the study.~      Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing~     two arms:~        -  (R-7d) Rivaroxaban (10 mg od os) for 7 days~        -  (PL-7d) Placebo for 7 days.~      Follow-up: 3-month period after the randomization~      Standard of Reference:Placebo will be the standard of reference in accordance to~     international guidelines~      Study length May 2012-December 2012~      Total patients number: 500 patients~      Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at~     least one of the following events, objectively proven (by means of CCDU; multi-slice chest~     TC-angio; autopsy, if necessary, or clinical ground):~        -  All-cause mortality~        -  Symptomatic VTE~        -  Asymptomatic proximal DVT~      Secondary Efficacy End-point:~      • Combined incidence of all DVT plus symptomatic PE~      Primary Safety End-point: Incidence of major bleedings.~      Secondary Safety End-point: Overall incidence of bleeding~   "
109011|NCT01629368|"~     This single-center, open-label, cross-over study will evaluate the effect of carbamazepine~     on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive~     a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in~     a cross-over design. The anticipated time on study treatment is 40 days.~   "
109012|NCT01629355|"~     The purpose of this study is to study the predictive value of SensoDetect-BERA as a~     diagnostic tool in clinical practice for schizophrenia and bipolar disorder.~   "
109013|NCT01629342|"~     STANDARDIZED PHYSICAL ACTIVITIES MEASURED BY ACCELEROMETERS Background and aims: Physical~     activity may be assessed by several different methods. However, the use of accelerometers is~     the most direct method available for real-time measurements. The piezoelectric element of~     accelerometers records an electric voltage during movement which is then transcribed to~     Activity Counts (AC). Few studies have used Actical accelerometers to assess standardized~     physical activities and most of these were not applicable to patients in a hospital setting.~     No previous studies have applied Actical accelerometers to the wrists or ankles during~     standardized activities. The aim of this study is to record AC during different standardized~     activities frequently done by patients hospitalized for acute ischemic stroke.~      Methods: Patients discharged since February 2012 after a transient ischemic attack have been~     invited to participate in the study scheduled for June-September 2012 (nexpected=25). All~     participants wear 5 accelerometers (Actical), one at each wrist and ankle and one over the~     hip. Standardized physical activities include:~        -  treadmill walking (5 minutes, 1 and 4km/h)~        -  staircase walking (1 floor, normal pace)~        -  cycling with fixed load (5 minutes)~        -  standing up from sitting position and sitting down again (x5)~        -  standing up from supine position~        -  turning from left to right and back while lying in bed~        -  raising outstretched arm 90° (x5, standing position)~        -  eating (5 minutes, sitting position)~        -  drinking a glass of water~        -  sleeping (6 hours)~   "
109014|NCT01629329|"~     The objective of this randomized, double blind study is to demonstrate that one dose oral~     excedrin migraine (acetaminophen, aspirin and caffeine) is not inferior when compared to~     one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in~     the emergency department.~   "
109023|NCT01629212|"~     The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and~     Octylonium bromide in the Treatment of Irritable Bowel Syndrome.~   "
109015|NCT01629316|"~     Purpose: The purpose of this study is to determine if a comprehensive intervention~     supporting seek-test-and-treat results in a significant reduction in the potential for~     HIV-infected prisoners to transmit their virus after release from prison.~      Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT~     (imPACT) intervention on viral load 24 weeks following prison release.~      Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT~     study arms. These outcomes include post-release HIV transmission risk behaviors, incident~     STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations,~     and predicted HIV transmission events.~   "
109016|NCT01629303|"~     Subjects with refractory chronic constipation are offered two conventional therapeutic~     strategies: either medical treatment, either surgery (in the case of medication failure).~     Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the~     sacral nerve modulation. This procedure consists in stimulating the nerves which control the~     contractions of the colon and so the defecation phenomenon. Several open trials have~     suggested that sacral nerve modulation may be effective in reducing constipation and related~     symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral~     nerve stimulation in patients with constipation.~   "
109017|NCT01629290|"~     This study will be a cross-over single blinded clinical study to evaluate the in vitro~     fluoride release of three different brands of 5% NaF varnish. Subjects will be recruited at~     the University of Michigan School of Dentistry and will participate in a 15 minute clinical~     session at the beginning of each study arm, followed by 6 saliva collection recalls. During~     these sessions a fluoride varnish or placebo will be applied to their teeth, and subsequent~     salivary samples will be taken 1 hour, 4 hours, 6 hours, 24 hours, and 48 hours after the~     application. All subjects will receive 3 commercially available varnishes, and a placebo~     varnish. Between applications there will be a minimum of 2 weeks wash-out period. The goal~     of this study is to determine if different formulations of varnish lead to differing amounts~     of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data~     have suggested that they may differ in the amount of fluoride release. Determining fluoride~     release of these varnishes in vivo is important in assessing both the safety and efficacy of~     the product.~      Specific Aims~        1. Determine the concentration of fluoride available in the oral cavity at different time~          periods after the application of three different 5% NaF varnishes as measured in~          unstimulated human saliva.~        2. Compare the different patterns of fluoride release from each of the varnishes by~          comparing the fluoride concentration in saliva at corresponding time periods .~        3. Evaluate the validity of an in vitro model used to measure fluoride release from~          varnishes.~      Percentage difference in fluoride release between the in vivo and in vitro data obtained~     from the same products will be compared.~   "
109018|NCT01629277|"~     The ultimate goal of the investigators ongoing research is the development of a closed-loop~     system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight~     glucose control avoiding the risk of hypoglycaemia. The main components of the system are a~     continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive~     algorithm', which computes the amount of insulin to be given by the insulin pump according~     to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop~     glucose control was evaluated both overnight and over a prolonged period of time including~     the day-time in children and adolescents with T1D. The results showed that closed-loop~     improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the~     conventional insulin pump therapy.~      The objective of the current study is to test the performance of closed-loop further, by~     evaluating the system during common non-compliant behaviours in the administration of meal~     insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use~     of closed loop systems to control glucose levels in T1D under various real-life mimicking~     common circumstances. The present study adopts an open-label, randomised, 2 period~     cross-over design whereby closed-loop insulin therapy will be compared with the conventional~     insulin pump therapy in 12 adolescents with T1D.~      Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical~     research facility, during which glucose levels will be controlled by either the~     computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump~     therapy (control arm). On both occasions, participants will under-estimate and omit the~     meal-related insulin dose for the evening-meal and lunch, respectively. The study will take~     place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants~     recruited from paediatric diabetes clinics in England.~   "
109019|NCT01629264|"~     The intraocular pressure in the human bulbus requires that the wall of the eye shows a~     certain (bio)mechanical strength. The human cornea represents the anterior portion of this~     wall. Since several years, there is a growing interest in the ophthalmological community for~     identifying factors modulating the biomechanical stability of the human cornea. Reasons are~     twofold: advances in keratoconus research and the increasing numbers of refractive laser~     surgery procedures with (correspondingly) increasing numbers of complications due to~     non-respecting the limits of corneal biomechanics.~      There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on~     corneal biomechanics. A number of recent observational studies have reported on keratoconus~     and refractive laser surgery patients with decompensating biomechanics during pregnancy.~      Both hormones also show physiological changes during pregnancy and little is known about the~     impact of these physiological changes on the human cornea.~      The aim of this study is to establish baseline values for physiological changes in the human~     cornea during pregnancy.~   "
109020|NCT01629251|"~     The main focus of our research is the development of a closed-loop system for glucose~     control in people with type 1 diabetes. After having demonstrated the safety and efficacy of~     overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to~     the daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing~     can be associated with the occurrence of postprandial hypoglycaemia, thus representing a~     confounding factor of hypoglycaemia free glucose control during the day. A further~     investigation is needed to evaluate alternative strategies for prandial insulin dosing. We~     will study eight adolescents with type 1 diabetes during closed-loop insulin delivery~     combined with either standard or reduced insulin doses with the meals, in a randomised~     crossover design. Stable glucose isotopes will be administered to collect data for modelling~     of glucose turnover around the meals, during daily activities and overnight.~      The information provided by the use of glucose isotopes would be very helpful to increase~     our understanding of the physiology of glucose turnover and to facilitate the development of~     an improved control algorithm. Ultimately this study will help with the development of a~     closed-loop system to match insulin infusions to change in glucose levels in real life~     conditions.~   "
109021|NCT01629238|"~     The purpose of this study is to describe the cardiovascular risk profile in subjects who~     consume a marketed drinkable low fat fermented milk enriched with plant sterol.~     Investigations are lead prospectively and retrospectively among adults enrolled from general~     practitioners' database.~   "
109026|NCT01629173|"~     The aim of the study was to investigate the effectiveness of dynamic impression insoles on~     plantar pressure and pain reduction. A dynamic impression insole was made by sequential~     padding with Plastazote and P-cell under daily walking compression. The pain levels and~     plantar pressure with the use of dynamic impression insole were assessed and compared with~     7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded~     insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was~     assessed using a Visual Analog Scales.~   "
109027|NCT01629160|"~     The purpose of this study is to evaluate feasibility of using new technologies to~     characterize ventricular wall motion in patients indicated for mapping and ablation~     procedures. Echo will be performed preoperatively and patients will receive a 1-month~     followup telephone call.~   "
109028|NCT01629147|"~     Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in~     children 4-10 years of age.~   "
109029|NCT01629134|"~     A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine~     in the lips.~   "
109030|NCT01629121|"~     The hypothesis was that the implementation of a Safe Kids East Central brain injury~     prevention program targeting children and caregivers admitted to the Georgia Health Sciences~     University Children's Medical Center is feasible and that short-term treatment effects of~     injury prevention education on the child or adolescent and the caregiver will increase~     bicycle helmet use.~   "
109031|NCT01629108|"~     Background:~      - Researchers at the National Institutes of Health give many tests of hearing and balance.~     These tests can help detect problems that affect hearing or balance. It is important to know~     exactly how healthy people perform on each of these tests. This information will indicate~     when a test result is normal and when a test result shows a problem. Researchers also want~     to determine the best methods for each test.~      Objectives:~      - To test different types of hearing and balance tests, and collect information on normal~     values for each test.~      Eligibility:~      - Healthy volunteers between 5 and 70 years of age.~      Design:~        -  This study will require a single visit to the National Institutes of Health Clinical~          Center. It will include both screening tests and study tests of hearing and balance.~          Sometimes, a second visit may be required if a test is designed to measure the same~          thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the~          number of tests scheduled per visit.~        -  Participants will have a physical exam and medical history. They will also have basic~          tests to check for normal hearing and balance.~        -  Participants may have different hearing tests, including the following:~        -  Auditory Evoked Potentials to study how the ears and brain handle sound information.~        -  Auditory Processing Tests to study how a person processes complex sounds like speech in~          background noise.~        -  Tests of middle ear and inner ear function.~        -  Participants may have different balance and inner ear tests, including the following:~        -  Balance test on a tilting platform.~        -  Different tests to measure how well the eyes, ears, and brain work together to help~          maintain balance.~        -  Treatment will not be needed as part of this study.~   "
109032|NCT01629095|"~     Background:~      - Non-alcoholic fatty liver disease is the most common form of liver disease in the United~     States. It includes many conditions. Researchers want to study fatty liver disease by~     looking at people who have liver cirrhosis. They also want to look at people who are or were~     listed for liver transplants. Genetic studies may provide more information on the causes of~     these conditions.~      Objectives:~      - To study possible genetic causes of non-alcoholic fatty liver disease.~      Eligibility:~      - Individuals of any age who have non-alcoholic fatty liver disease and related conditions.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide a blood sample for genetic testing. Liver tissue from a~          transplant or biopsy may also be studied.~        -  Participants may also be asked to have an imaging study of the liver. This imaging~          study may be an x-ray or magnetic resonance imaging.~        -  No treatment will be provided as part of this research study.~   "
109033|NCT01629082|"~     Background:~        -  Several types of blood cancer are associated with poor outcomes including high-risk~          myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute~          myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for~          standard treatments. New types of treatment are needed for these cancers.~        -  Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in~          the body. The second can alter blood supply to abnormal cells or affect how the immune~          system attacks these cells. These drugs have been previously tested as treatments for~          MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and~          AML. Researchers want to see if these drugs are safe and effective for these types of~          cancer.~      Objectives:~      - To test the safety and effectiveness of clofarabine and lenalidomide for people with~     high-risk MDS, CMML, and AML.~      Eligibility:~        -  Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.~        -  Participants must not be candidates for standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and bone~          marrow samples will be collected.~        -  Participants will have 5 days of treatment with clofarabine. It will be given through a~          vein during an inpatient hospital stay. If there are no serious side effects after the~          infusion, participants will continue treatment as outpatients.~        -  After 28 days, participants will have a bone marrow biopsy to check their response to~          treatment.~        -  After the biopsy, participants will start lenalidomide treatment. Half of the~          participants will take the drug for 28 days (one treatment cycle). The other half will~          take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor~          treatment.~        -  If there are no serious side effects and the disease does not become worse,~          participants may keep taking lenalidomide at lower doses for up to 12 more cycles.~   "
109034|NCT01629069|"~     The overall aim of this protocol is to examine patient and care-giver outcomes and~     acceptance of a new 6 week intervention in Arizona for our transplant and cancer patients~     and their care-givers, designed to improve quality of life, decrease perceived stress, and~     improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic~     in Arizona.~   "
109035|NCT01629056|"~     This study aims to investigate the benefit of a new impedance-based computer software~     application during routine catheter ablation for atrial fibrillation, to see if this~     information improves short and long term electrical disconnection of the pulmonary veins.~     This study will be a single blind prospective randomised control trial in patients~     undergoing AF ablation. Study participants will be randomly assigned to undergo parts of~     their pulmonary vein ablation with, and parts of their ablation without tissue contact data~     displayed for the doctor performing the ablation to see. The pulmonary veins will then be~     studied at the end of the procedure, and at any repeat procedure in the future, to look for~     a difference in the recovery rate of the ablations performed using contact data, compared to~     those ablations performed without the use of this contact data. If a reduction in tissue~     recovery is achieved through the use of this tissue contact data, it may lead in the future~     to a reduced need for repeat ablation procedures, and better outcomes for patients.~      The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the~     recovery of conduction, and promote long-term pulmonary vein isolation in patients~     undergoing left atrial ablation for atrial fibrillation.~   "
109054|NCT01628809|"~     The purpose of this study is to determine the effects of a three-day mindfulness meditation~     retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on~     brain function, brain structure, and overall health and immunity.~   "
109055|NCT01628796|"~     Is it possible to improve the accuracy of injection into the acromio-clavicular joint with~     the use of ultrasound?~   "
109036|NCT01629043|"~     In a recent study it was found that neurologist care for Parkinson's provides a 20%~     reduction in nursing home placement, hip fracture, and death (Willis 2011). However, as the~     authors recognized, the investigators don't know what it is about expert care that delivers~     this benefit. The National Parkinson Foundation's Quality Improvement Initiative was~     designed to identify the components of great care that yield great outcomes. By capturing~     demographics, clinical interventions and outcomes over time from multiple centers across the~     U.S, Canada and internationally, the best care practices from different clinics and~     different healthcare systems will be analyzed.~   "
109037|NCT01629030|"~     The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts~     as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.~   "
109038|NCT01629017|"~     This project allows for the systematic collection and analysis of long-term follow-up~     clinical parameters in children who have received a stem cell transplant. The data collected~     will assist in determining appropriate intervention and treatment plans for patients~     enrolled on this study. In addition, future patients may benefit by having the ability to~     anticipate problems and develop methods of prevention or early intervention.~   "
109039|NCT01629004|"~     The investigators hope to determine whether the addition of an FOBT kit and educational~     materials to a second mailed invitation compared to a second mailed invitation alone~     increases use of appropriate screening tests (FOBT for average risk or colonoscopy if~     increased risk) by eligible persons within 6 months of the second mailing in:~     (1)Non-responders to an initial mailed CRC screening invitation from their family physician~     and, (2)Those who responded to the initial mailed CRC screening invitation and are due for~     repeat screening (i.e., recall patients). In addition, the investigators will also explore~     the impact of the investigators intervention in likely under-screened groups such as those~     living in more remote areas of the province and those with low socio-economic status as well~     as assessing the cost-effectiveness of this strategy.~   "
109040|NCT01628991|"~     This study is a single blind randomized clinical trial to compare the efficacy of a~     behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).~   "
109041|NCT01628978|"~     The investigators are trying to evaluate the efficacy of ultrasonographic determination of~     depth of endotracheal tube placement in infants and young children by using the pleural~     sliding sign.~   "
109042|NCT01628965|"~     Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease~     patients who are not concomitantly treated with L-dopa will be investigated with a doses.~   "
109043|NCT01628952|"~     This is a Biomedical Research, prospective, randomized, controlled single-blind mono~     centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle~     relaxation of the abdominal wall during laparoscopic digestive surgery.~   "
109044|NCT01628939|"~     The purpose of this study is to determine~        1. the prevalence of lumbar facet joint pain detected by manual segmental provocation~          tests~        2. the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion,~          edema)~        3. the association of lumbar facet joint pain and MRI findings on a segmental level~      in subjects with current low back pain and in a control group.~   "
109045|NCT01628926|"~     -  To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in~          order to confirm clinical value of SPM 962.~        -  To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.~        -  To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.~   "
109046|NCT01628913|"~     This was a multicenter, open label, randomized phase II study to evaluate the efficacy and~     safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate~     grade pancreatic neuroendocrine tumor (pNET).~   "
109047|NCT01628900|"~     The prevalence of acute pyelonephritis (PNA) is 60-75 000/year. They are traditionally~     classified as uncomplicated (60-65%) and complicated. If it is assumed that the~     uncomplicated PNA can be treated as outpatients with a cure rate of over 80%, the second~     group is very heterogeneous. Some patients are severely infected. But others, despite an~     older age, structural urologic abnormalities or a controlled history, have no risk factors~     and can be simply managed. The investigators propose to reclassify the PNA into 3~     categories: uncomplicated PNA (PNA-1), the PNA of moderate severity (PNA-2), the major PNA~     (PNA-3) to test whether the PNA-2 can benefit from the same outpatient care that the PNA-1.~     The existence of biological markers of the severity of bacterial infections would further~     support a tailored approach. The pro-adrenomedullin (pro-ADM), successfully tested to~     identify severe community acquired pneumonia, is a an interesting candidate.~   "
109048|NCT01628887|"~     This clinical trial studies a supportive education program for Latina breast cancer~     survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast~     cancer survivors know what to expect after completing breast cancer treatment and prepare~     them to cope with cancer related survivorship issues~   "
109049|NCT01628874|"~     The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection~     system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a~     topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with~     1% lidocaine will provide local anesthesia that is comparable to that of a topical~     anesthetic agent (EMLA cream) when performing lumbar punctures in children.~   "
109050|NCT01628861|"~     The purpose of this study is to determine whether an on-screen prompt put on the work~     computer every 30 minutes is effective in getting office workers to reduce prolonged periods~     of sitting at work.~   "
109051|NCT01628848|"~     The primary objective of this study is to investigate efficacy and safety of SPM 962 in~     advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study~     following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg~     (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also~     to be investigated with distribution of the maintenance dose and accumulated response rate~     of efficacy.~   "
109052|NCT01628835|"~     The study is a randomized, single-blinded, controlled intervention trial to compare the~     effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for~     Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.~   "
109056|NCT01628783|"~     In this study the investigators use clinical, biological and imaging markers to develop~     predictive markers for remission from depression. The investigators compare individuals who~     have received placebo to individuals who have received 10 mg of escitalopram for one week.~     In this double-blind, randomized study the investigators a) compare the groups to observe~     the short-term effects of escitalopram and b) study the predictive value of these~     observations with respect to remission. Measures include, but are not restricted to, limbic~     emotional reactivity as assessed by fMRI, emotional processing, emotional memory,~     autobiographical memory.~   "
109057|NCT01628770|"~     The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron~     preparation will be equally effective in correction of postpartum iron deficiency anemia.~   "
109058|NCT01628757|"~     Cervical cancer is one of the major health problems for chinese women. Besides surgery and~     radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many~     studies.~      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic~     effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic~     burden, but also more importantly save time to take more suitable treatments.~      This study is undertaken to build a model combine both clinical and genetic factors to~     predict the effects of neoadjuvant chemotherapy.~   "
109059|NCT01628744|"~     In adult, the prevalence of mycobacterial infections is increased with age is largely~     unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in~     adult against mycobacteria. Based on this hypothesis, the investigators had applied a~     functional assay to these pathways in patients with mycobacterial infection.~   "
109060|NCT01628731|"~     This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide~     continuous infusion in total urine output production during the first 24 post operative~     hours.~   "
109061|NCT01628718|"~     The primary objective of this randomized controlled non-inferiority trial is to determine~     whether or not Adaptive Disclosure (AD), a new combat-specific psychotherapy for Post~     Traumatic Stress Disorder (PTSD), is as least as effective as Cognitive Processing Therapy,~     cognitive only version (CPT-C), in terms of its impact on deployment-related psychological~     health problems (specifically PTSD and depression) and functioning.~   "
109062|NCT01628705|"~     Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk~     factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies~     have suggested that drink green tea could improve these complications.~      Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL,~     fat mass and TNFa in obese women.~      Design: Randomized, controlled clinical trial. Obese women, without other~     chronic-degenerative disease were divided using a computer-generated random sequence:~     control group (CON) with n=32, and intervention group (INT) with n=32; and were instructed~     to consume a moderate-fat diet, and INT group was instructed to complement the diet with~     green tea. Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s~     levels were determined by ELISA. All parameters were realized at baseline and in the 1st,~     2nd and 3rd months post-intervention. TNFa mRNA expression was determined by real-time~     RT-PCR (basal and final). The changes on lipid profile, oxLDL, fat mass and TNFalpha~     expression were reported of the comparison between basal and final time points. The~     statistical analysis was performed with SPSS software.~   "
109063|NCT01628692|"~     The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir~     with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients~     who are treatment-naive or null responders to previous pegylated interferon/ribavirin~     therapy.~   "
109064|NCT01628679|"~     Hypothesis:~        1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor~          control, increase self efficacy, improve sexual function and decrease pain~          catastrophizing behaviour in women with provoked vulvar vestibulodynia.~           This study will look at specific physiotherapy treatment interventions to see if they~          decrease pain, improve pelvic floor motor control, increase self efficacy, improve~          sexual function and decrease pain catastophizing behaviour. Participants will fill out~          a questionnaire on their pain symptoms and complete standardized scales prior to~          starting treatment and after 4 sessions to determine change due to interventions.~        2. A combination of physiotherapy, group educational sessions and group cognitive~          behavioural therapy will have better outcomes than physiotherapy alone.~      Results of physiotherapy intervention alone will be compared to results of those treated~     with physiotherapy, group educational sessions and group cognitive behavioural therapy at a~     separate treatment centre. Physiotherapy interventions and outcome measures are the same~     between both groups.~      Justification:~      Standard treatment is hard to identify as many approaches are taken, none with any evidence~     to support them. This study aims to look at specific techniques (pelvic floor coordination~     and relaxation exercises, education on female sexual response and pain pathophysiology~     education) to see if there is a benefit.~   "
109065|NCT01628666|"~     The goal of the study is to compare whether a center-wide policy of incremental antibiotic~     therapy will reduce CIED infection rate compared to a policy of conventional antibiotic~     prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics~     used are approved for use and readily available.~   "
109066|NCT01628653|"~     The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced~     Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly~     individuals with mild cognitive impairment (MCI).~   "
109067|NCT01628640|"~     The primary purpose of this study is to evaluate the safety of a viral agent called~     vesicular stomatitis virus for the use in patients with liver cancer. The study virus has a~     gene inserted into it which will allow for the production of interferon beta, which is a~     substance that will have the dual functions of restricting the spread of the virus to the~     tumor cells and not healthy liver cells and also to have some independent anti-cancer~     activity. Although the primary goal of this study is to evaluate the safety of delivery of~     this viral agent to people, patients may benefit clinically by having shrinkage or~     stabilization of their tumor or reduction in their cancer related symptoms (e.g. pain). -~     Funding Source - FDA OOPD~   "
109068|NCT01628627|"~     Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated~     electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in~     patients with diabetes mellitus.~   "
109072|NCT01628575|"~     Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining~     alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this~     technique orthodontic de-crowding and space closing, can be completed in 60-70% less active~     orthodontic treatment time. The addition of particulated bone graft following decortication~     allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space~     for the movement of teeth, without the creation of dehiscences, usually a negative sequel of~     the standard orthodontic treatment.~      Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year~     post orthodontic treatment.~      Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were~     admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All~     patients underwent full orthodontic and periodontal examination upon admission including a~     pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic~     appliances have been placed. The orthodontic appliances were activated immediately after~     surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic~     clinical evaluation were made, as well as a CBCT scan.~   "
109073|NCT01628562|"~     It was hypothesized that the use of esmolol as an alternative to remifentanil with~     sevoflurane inhalation anesthesia during intracranial surgery, could provide better~     hemodynamic conditions and cause lesser side effects in the perioperative period. It was the~     main objective of this study to compare the effect of esmolol and remifentanil on the~     incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The~     comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes~     were the secondary objectives.~   "
109074|NCT01628549|"~     To evaluate the safety and effectiveness of 3 strengths of P005672 compared to placebo for~     the treatment of moderate to severe facial acne.~   "
109075|NCT01628536|"~     The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will~     reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in~     a pre-operative setting.~   "
109076|NCT01628523|"~     Despite its life-saving potential, the mechanical ventilator has great potential to do harm.~     Despite years of research, the mortality in acute lung injury (ALI) remains very high.~     Treatment options after ALI onset are very limited, therefore prevention may be the best~     option. Unfortunately, the emergency department has not been studied with respect to~     mechanical ventilation practices, and its contribution to ALI is unknown. The investigators~     hypothesize that mechanical ventilation is frequently used in the ED and for a variety of~     reasons, and that ED mechanical ventilation has an effect on long term outcomes.~   "
109077|NCT01628510|"~     The purpose of this study is to investigate the developmental effects of two different types~     of positioning used with premature infants in the neonatal intensive care unit.~   "
109078|NCT01628497|"~     This study is looking at the difference in exhaled nitric oxide levels in patients with and~     without laboratory evidence of filariasis.~   "
109079|NCT01628484|"~     The objectives of this monocentric investigator initiated exploratory clinical trial is to~     optimize allergen delivery across the epidermal barrier. The cornified outer epidermal~     layers represent the main barrier towards entry into the viable epidermal layers. In the~     latter we aim to target the allergen for uptake by professional antigen presenting cells,~     called Langerhans cells. At the same time as little allergen as possible should be delivered~     to the dermis. The latter contains a high density of sensitized mast cells eliciting local~     reactions and also a high density of blood vessels which could lead to systemic distribution~     of allergen and therefore to systemic allergic reactions.~      In birch pollen allergic individuals we will compare different methods of preparing the skin~     before application of the allergen. We will subsequently apply titrated allergen doses to~     the prepared skin areas to determine at which dose we start observing mast cell~     degranulation manifesting as hives.~      This will allow for determination of the maximal tolerated allergen dose for each skin~     preparation method.~      The skin preparation methods compared will be:~        -  Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK,~          distributed by Stallergenes®).~        -  Tape stripping with conventional adhesive Tape (Tesa-film®).~        -  Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are~          strongly connected to routine diagnostics of allergies with low risk associated.~      The clinical trial protocol has been submitted to the local Ethics Committee.~      This comparison of skin preparation methods and the determination of the maximal tolerated~     allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has~     the potential to make allergen specific immunotherapy not only considerably shorter and~     safer, but also more convenient for patients. Skin preparation by microneedle patches is~     significantly less painful than conventional injection and can be self administered. This~     should help improve the acceptance of allergen specific immunotherapy, as well as treatment~     compliance.~   "
109080|NCT01628471|"~     Lung cancer is one of the most prevalent and lethal neoplasias in the world. Currently used~     chemotherapy regimens have been disappointing in improving overall survival. Decitabine is a~     S-phase pyrimidine analog that induces DNA hypomethylation. This drug is currently used to~     treat Myelodysplastic Syndrome ( MDS) and has been studied for the treatment of leukemia.~     Genistein, is a soy extracted non-toxic isoflavone and phytoestrogen, which has been shown~     to inhibit activity of cell signaling pathways, such as those driven by tyrosine kinases.~     Results from in vitro experiments unambiguously demonstrated that the combination of these~     two compounds induces a synergistic reduction of the multiplication of lung, colon, breast~     and leukemic cancer cells. Consequently, clinical evaluation of this drug combination is~     warranted in Non Small Cell Lung Cancer ( NSCLC), and it is hypothezised that this new~     regimen will safely improve overall tumor response rate and cancer progression free~     survival.~      The proposed trial is a two part study: The phase I part is an open-label, dose-escalation~     evaluation in subjects with advanced solid tumors who have failed standard therapies and for~     whom no curative therapeutic option exists.~      A cohort of three subjects will be treated per dose level. One cycle is 28 days. Five~     different, increasing dose levels ranging from 60 mg/m2 to 500 mg/m2 of IV decitabine~     combined with a fixed oral dose of 150 mg BID of genistein will be tested. The Maximum~     Tolerated Dose (MTD) will be determined based on the occurrence of Dose Limiting Toxicities~     (DLTs).~      In the phase IIa part of the study, only Stage IIIb and IV advanced NSCLC patients will be~     treated at the recommended decitabine MTD dose combined with genistein. Safety and~     preliminary efficacy will be assessed. It is expected that a maximum sample of 46 patients~     will be enrolled in this trial.~   "
109081|NCT01628458|"~     The purpose of the study is to determine the safety of radiofrequency ablation of locally~     advanced pancreatic cancer that can not be surgically removed with the current standard~     procedures. Complications after the operation will be registered. Moreover a pain score will~     be determined, length of hospital stay, chemotherapy, survival, progression free survival~     and a tumour marker.~   "
109082|NCT01628445|"~     Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated~     with improved blood glucose control, weight loss and low rates of hypoglycemia when used~     alone or in combination with metformin. Liraglutide has not been extensively tested in~     people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day).~     Often these patients are insulin resistant and despite using large doses of insulin are not~     able to achieve glucose targets. The rationale for this study is to assess if the addition~     of liraglutide in addition to usual care versus placebo can improve blood glucose levels in~     people not achieving a target HbA1C of less than 7.0%.~   "
109084|NCT01628419|"~     The purpose of the current investigation is to examine the effects of health intervention~     program at the workplace on health risks for cardiovascular disease, well-being and~     absenteeism at the workplace.~      Participants: 1500 male and female employees from 10 different companies across Israel will~     take part in the study. Age: older than 18 yrs.~      Hypothesis 1: The intervention program will have positive effects on the health risks for~     cardiovascular disease. For example: Will be reflected in a decrease in LDL and increase in~     HDL.~      Hypothesis 2: The intervention program will have positive effects on the absenteeism at the~     workplace (e.g. decrease in days of sick leave per employee).~   "
109085|NCT01628406|"~     The investigators record all indications, treatments and outcomes from patients treated at~     the Neurosurgery Department.~        -  Trial with surgical intervention~   "
109086|NCT01628393|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
109087|NCT01628380|"~     Aim of the Study is to compare two-years disease-free survival of Cytoreductive Surgery~     (CRS) and Hyperthermic IntraPEritoneal Chemotherapy (HIPEC, CDDP+Paclitaxel) vs CRS alone in~     Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response~     after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).~   "
109088|NCT01628367|"~     An important result of healing after tooth extraction is a reduction in dimensions of the~     remaining bone at that site. This reduction of bone volume precludes successful restoration~     of the space using a dental implant. Bone augmentation has shown promise in clinical reports~     to reduce this loss of bone volume, thus allowing implant placement and restoration. The~     purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone~     regeneration around dental implants placed in fresh extraction sockets.~   "
109089|NCT01628354|"~     The investigators hypothesize that it is safe and effective to treat patients with choroidal~     neovascularisation (abnormal blood vessels growing under the retina) secondary to causes~     other than age related macular degeneration (AMD) and pigment epithelial detachments~     (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis).~      These groups of patients have to date been excluded from the multicentre trials~     demonstrating significant benefit of Ranibizumab in the treatment of AMD.~   "
109090|NCT01628341|"~     This non-interventional study is conducted in Europe. The study is both retrospective and~     prospective.~      The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in~     insulin-treated patients with type 1 and type 2 diabetes.~   "
109091|NCT01628328|"~     This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting~     for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell~     before and after the procedure of successful colonic stenting in patients.~   "
109092|NCT01628315|"~     -  To examine short- and long-term value of appearance of new active lesions in predicting~          extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA~          (Avonex- Steroid-Azathioprine)study.~        -  To explore how accumulation of cortical and SDGM atrophy over 5 years differs with~          respect to the number of new active lesions or amount of disease activity, in early~          relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop~          sustained disability progression.~        -  To examine the relationship between development of cortical and SDGM atrophy and~          regional likelihood of development of new active lesions over 5 years.~   "
109093|NCT01628302|"~     The present prospective, randomized, crossover study is designed to investigate the effect~     of salt consumption on blood pressure in hypertensive subjects.~      Secondary objectives of the study are to evaluate the effect of salt consumption on blood~     pressure among the subjects who are hypertensive and obese and normal according to body mass~     index and to evaluate the effect of salt consumption on renin activity in hypertensive~     subjects.~   "
109094|NCT01628289|"~     Introduction: There is no debate that people with diabetes should be screened for the~     development of retinopathy which can threaten their sight. However, there is no routine~     screening for retinopathy in Hong Kong at present. Many overseas countries find that they~     miss a large proportion of their target population and, with reliance on co-payments for~     screening, as is the case with the limited opportunistic screening at present, the~     cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by~     Hart's inverse care law.~      Aim: This study will determine the potential cost-effectiveness of screening for retinopathy~     in Hong Kong under a free system and one in which a co-payment is charged.~      Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for~     their routine diabetic care will randomly be offered screening either at no charge or with~     the normal co-payment of $65. Those who are willing and unwilling to be screened will be~     compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling~     will be asked their reasons. The uptake of screening at no fee and with a payment will be~     compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening~     at one year will be offered at the same fee and uptake again compared.~      The principal analyses will (a) identify the characteristics of those willing to be screened~     and reasons for not being screened (b) the uptake of screening when a co-payment is charged~     compared to when it is free (c) whether there is a difference in the prevalence of~     retinopathy between the group willing to pay and those who accept free screening and (d) the~     uptake of re-screening in year 2.~      The resulting cost-effectiveness model will use these data, the cost data collected during~     the study and overseas data on benefits of treatment to model the cost-effectiveness of~     screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment.~     This information will be important to determine the most cost-effective means of~     implementing this preventative strategy to preserve sight and quality of life.~   "
109095|NCT01628276|"~     This trial seeks to investigate brain network changes following cognitive rehabilitation in~     MS patients. The investigators hypothesize that rehabilitation interventions improve~     connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to~     investigate changes in brain plasticity.~   "
109096|NCT01628263|"~     The aim of our study is to determine the feasibility of carrying out a randomized controlled~     trial (RCT) to investigate whether screening parents of children admitted to pediatric~     intensive care unit (PICU) so as to target follow-up at those most at risk of developing~     posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological~     sequelae.~   "
109097|NCT01628250|"~     Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery~     technique to perform a resection for colon cancer. Besides, the segment of the colon~     containing the tumor, the resection area should include an intact mesocolon as an envelope~     to encase the possible route for metastasis. The routes include blood vessels, lymphatic~     drain and etc. Such hypothesis predicts better histopathological and higher oncological~     results which turns into better survival rate and better quality of life.~   "
109118|NCT01627977|"~     The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin~     and brilliant blue to stain the internal limiting membrane as well as the epiretinal~     membranes during the Vitrectomy surgery.~   "
109098|NCT01628237|"~     Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe~     handicap for patients and represents a considerable expense for healthcare system.~     Neurostimulation has currently not been validated in the treatment of back pain because of~     technological limitations in implantable spinal cord stimulation (SCS). The lack of a~     validated technique for back pain relief has prompted the development of newer devices,~     including leads with increased number of contacts (up to 16) and various geometric~     arrangements, the objective of which is to cover a larger area while attempting to extend,~     steer, or focus the electric field of the stimulation within the spinal cord regions. This~     led companies to design a new generation of multicolumn surgical leads that allow the~     activation of longitudinal and transverse electric fields (multicolumn spinal cord~     stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.~      The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal~     and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using~     axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment~     of lumbar pain.~      A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and~     80 years old suffering from refractory neuropathic pain of radicular origin with associated~     back pain will be included. Patients will be divided into two groups. One group with MSCS~     during the 12 months after the new generation electrode implantation and one group with CSCS~     during 6 months and MSCS between 6 and 12 months after the new generation electrode~     implantation.~      The following parameters will be evaluated during this study: overall pain VAS, leg pain~     VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating~     scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and~     costing in relation to surgery and patient management.~   "
109099|NCT01628224|"~     This study involves two tasks. The first involves observation of patient care during~     simulated aeroevacuation missions in order to gauge task saturation. The second involves~     review of records from actual evacuation flights in order to determine the effects of task~     saturation on patient care.~   "
109100|NCT01628211|"~     The purpose of this study is to evaluate whether a second-look laparoscopy, followed by~     peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in~     case of peritoneal carcinosis, improves the overall survival of patients who have had~     radical resection of mucinous colorectal cancer.~   "
109101|NCT01628198|"~     Despite the development of many drug therapies designed to treat high blood pressure~     (hypertension), it remains a considerable and poorly managed health, social and economic~     burden. For various reasons, including the high health care costs of treatment, there are~     estimates that up to 65% of patients with high blood pressure have untreated and/or~     uncontrolled blood pressure (BP).~      Aside from its effect on kidney function, chronic high blood pressure increases the risk for~     stroke, and heart disease. It is also thought to be involved in the formation of irregular~     heartbeats. This link between high blood pressure and heart health has been well described,~     as has their combined effect on the aging and the obesity-battling Western world.~      A recently published study (Symplicity HTN-2 trial) established the benefit of a new~     treatment procedure, catheter-based renal sympathetic denervation (RSDN) for hypertension,~     as having enormous potential for the treatment of patients with high blood pressure. This~     multi-center trial will attempt to confirm and expand on these promising data. Patients who~     enroll in the trial will be followed for 4 years.~   "
109102|NCT01628185|"~     Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is~     recommended in the general population, however it is not always possible in patients with~     altered neurological status such as sedated patients or patients with delirium.~     Consequently, pain assessment is highly challenging in these ICU patients. This is a~     prospective observational study assessing 3 behavioral pain scales in the ICU.~      The hypothesis of this proposal is that one of the three ICU pain scales has a more~     important reliability than the others. Such a scale could be recommended to be used to~     measure pain intensity in ICU patients not able to communicate.~   "
109103|NCT01628172|"~     Despite the development of numerous drug therapies designed to treat hypertension, it~     remains a considerable and poorly managed health, social and economic burden. For various~     reasons, including the significant health care costs of treatment, there are estimates that~     up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP).~      Aside from its impact on renal function, chronic hypertension significantly increases the~     risk for stroke, coronary artery disease, heart failure, and vascular disease. It is~     believed to be involved in the progression of cardiac arrhythmias. This link between~     hypertension and cardiovascular health has been well described; as has their combined effect~     on the aging and obesity-battling Western world.~      The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation~     in patients with treatment resistant hypertension) establishing the therapeutic benefit of~     catheter-based renal sympathetic denervation for hypertension, have enormous potential for~     the management of a large and challenging patient population. The proposed, multicenter~     trial will attempt to confirm and expand on this promising data by conducting a~     double-blinded, placebo-controlled trial.~      Patients may qualify to participate in this research study if their doctor has determined~     that they have drug-resistant, chronic hypertension.~      Overall participation in this research study should be about 13 months which includes about~     1 month to start the study procedure and 12 months of follow-up after the study procedure.~   "
109104|NCT01628159|"~     The purpose of the study is to collect additional safety and efficacy information on the~     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the~     femoral and popliteal arteries.~   "
109105|NCT01628146|"~     This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye~     study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic~     hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.~   "
109119|NCT01627964|"~     The study develops software for motion analysis and assessment of cardiac function for~     cardiac images. Cardiac catheterization ventriculography of several randomly selected~     patients were taken from our hospital's PACS system. The investigators remove the patient~     information on the images, and use the image for motion analysis and assessment.~   "
109120|NCT01627951|"~     An effective vaccine against malaria is urgently needed to combat the scourge of this~     disease. Before candidate vaccines can be tested in endemic countries, they are first tested~     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a~     candidate vaccine should be tested against multiple strains of malaria, representative of~     the disease's global distribution. To date, however, only one such strain (NF54) has been~     broadly used in CHMI's.~      The purpose of this study is to compare the course of infections with 2 novel malaria~     strains to those with NF54 in human volunteers.~   "
112312|NCT01586208|"~     Identify the most effective dose of valproic acid when used in combination with phenytoin~     for treatment of patients with refractory status epilepticus, which allow a better clinical~     course and prognosis of the disease.~   "
109106|NCT01628133|"~     The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion~     affects intestinal blood flow of premature infants during feedings and if so, whether return~     of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion.~      Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase~     in order to digest given feeding volume or overall decrease of intestinal blood flow) may~     predispose infants to feeding intolerance and to serious intestinal disease called~     necrotizing enterocolitis (NEC).~      Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm~     infants that can lead to decreased blood flow in different organs, including intestines.~     Thus, the determination of the presence or absence of PDA is an important part of the study,~     since it can be a relevant confounding variable.~      In this study, the investigators will assess intestinal blood flow by using sonogram to~     measure velocity through the superior mesenteric artery (SMA), the artery supplying most of~     the intestine, both pre- and 45 minutes post feeding. The investigators will also use~     echocardiogram to determine the presence or absence of PDA. Each set of measurements will be~     done immediately before and after the transfusion, and again 24 and 48 hours after the~     transfusion.~      Specific Hypothesis: The investigators hypothesize that infants will have attenuated~     postprandial blood flow velocities in immediate posttransfusion state when compared to the~     pretransfusion values. The investigators further hypothesize that normal, pretransfusion~     postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.~   "
109107|NCT01628120|"~     To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC~     administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in~     patients treated for anemia associated with chronic renal failure and on hemodialysis.~   "
109108|NCT01628107|"~     The purpose of the study is to determine the long-term safety in treatment-emergent adverse~     events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of~     target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal~     failure and on hemodialysis.~   "
109109|NCT01628094|"~     This randomized, open-label, multicenter study will evaluate the safety , efficacy and~     tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus~     (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In~     Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731,~     RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further~     treatment-naïve patients will receive a successful regimen from Part 1, or a reduced~     intensity regimen, and patients who have previously experienced null response to~     interferon-based treatment will be added to the study.~   "
109110|NCT01628081|"~     This is a double blind, parallel group, randomized study with 12 weeks of daily oral~     administration of Dunaliella or placebo in psoriasis patients.~   "
109111|NCT01628068|"~     Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of~     gastrointestinal bleeding. The investigators propose the percutaneous stop the oral~     anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in~     patients receiving anticoagulant therapy for atrial fibrillation without associated valvular~     heart disease, to reduce significantly the risk of stroke while minimizing the risk of~     bleeding in a group of patients with high risk for both events.~      ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is~     a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of~     atrial appendage left versus standard treatment with oral anticoagulants in patients with~     history of gastrointestinal bleeding and high embolic risk.~   "
109112|NCT01628055|"~     The purpose of the study is to evaluate the ability of IVIG to affect the rate of~     progression of brain ischemia, as evidenced by neuroimaging.~      The results of an ongoing epidemiological study indicate that patients with primary~     immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that~     is 5 times less than in the general population. Even more striking is the absence of stroke~     in IVIG-treated PID patients over 65, while in the same general population age group the~     stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection~     correlates with the length of IVIG treatment, since older PID patients have been treated~     with IVIG significantly longer than younger ones.~   "
109113|NCT01628042|"~     This study will investigate the impact of impaired renal function on the plasma~     pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in~     participants with overactive bladder and to guide recommendations on potential dosing~     adjustments for individuals with varying degrees of renal impairment.~   "
109114|NCT01628029|"~     The goal of this clinical research study is to learn about the effects of different~     combinations of melatonin, supportive counseling, light therapy, and methylphenidate/placebo~     in patients with cancer having sleep problems. The safety of these treatment combinations~     will also be studied.~      Methylphenidate is designed to increase the activity of the central nervous system.~      Melatonin is a hormone that is made by the brain and may help in letting your body know when~     it is time to go to sleep and when it is time to wake up.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     symptom, disease or illness. It is designed to be compared with a study drug to learn if the~     study drug has any real effect.~      Light therapy is designed to help people sleep better.~      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,~     pain, and/or sleep disorders.~      The use of the therapies to treat sleep disturbance in combination is experimental.~   "
109115|NCT01628016|"~     The purpose of this study is to test whether attention bias modification training is an~     effective neurobehavioral therapy to improve depressive symptoms.That is whether attention~     bias modification training is superior to placebo in reducing depressive symptoms over 1~     year after training.~   "
109116|NCT01628003|"~     It is hypothesized that the long-term results of rehabilitation and subsequent aging after~     Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive,~     emotional) reserves.~      The purpose of this study are:~        1. to determine whether such reserves exist.~        2. to study their convergent and discriminant validity.~        3. to study their characteristics.~   "
109117|NCT01627990|"~     The purpose of this study is to observe the tolerability, safety and efficacy of~     preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for~     cancer.~   "
109122|NCT01627925|"~     Upper airway obstruction (UAO) is a frequently occurring complication during induction of~     general anesthesia. The American Society of Anesthesiologist (ASA) closed claim analysis of~     anesthesia complications indicate that a difficult airway is one of the most challenging~     scenarios continuously facing anesthesia providers.~      The mechanism of UAO during anesthesia has not been well understood. Posterior displacement~     of soft palate, tongue and epiglottis are believed to be the primary contributing factors.~     Obesity is well known to be an essential characteristic which reflects propensity to UAO.~     The mechanism of UAO during anesthesia shares many similarities with the upper airway~     obstruction observed during obstructive sleep apnea (OSA). Nasal continuous positive airway~     pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success~     in patients with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese~     patients have a higher prevalence of UAO during anesthesia. Therefore, the investigators~     hypotheses that nCPAP should eliminate airway obstruction in obese patients under~     anesthesia. The investigators propose to test this hypothesis and determine the efficacy of~     nCPAP on maintaining airway patency in obese patients who require general anesthesia.~   "
109123|NCT01627912|"~     The purpose of this study is to investigate whether red and white wine consumption has acute~     effects on postprandial biochemical markers related to platelet aggregation, inflammation~     and oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.~   "
109124|NCT01627899|"~     Evaluation of the clinical benefits of One Touch VerioIQ system~   "
109125|NCT01627886|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
109126|NCT01627873|"~     The purpose of this study is to investigate the effects of two different analgesic methods~     (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status~     of patients.~   "
109127|NCT01627860|"~     The purpose of this study is to examine seizure control and tolerability of Topiramate after~     either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.~   "
109128|NCT01627847|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
109129|NCT01627834|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, oral bioequivalence study.~   "
109130|NCT01627821|"~     This investigation will be conducted as an interventional intention-to-treat clinical study~     in a population of end stage heart failure patients who meet specific inclusion and~     exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded~     (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with~     Post-Auricular Connector to an active control group treated with the PMA approved Thoratec~     HeartMate® II LVAS for Destination Therapy.~   "
109131|NCT01627808|"~     The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver~     resection, through the Vigileo/FloTrac system.~   "
109132|NCT01627795|"~     Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial~     surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from~     the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median~     survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients,~     regardless of the therapeutic approach.~      The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies~     and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12~     months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no~     dose-limiting toxicities observed.~   "
109133|NCT01627782|"~     The purpose of this study is to explore the optimal dose frequency of ketamine in patients~     with treatment-resistant depression (TRD).~   "
109134|NCT01627769|"~     It is well documented that following thermal burns injury the development of hypertrophic~     scars and keloid (HSK) ranges between 40 to 90%. on the other hand It is well documented~     that cryosurgery wounds generally heal with minimal tissue contraction, resulting in good~     cosmetic results and with minimal complications.~      The Aim of the study is To specify the burn and cryosurgery blister fluid for proteins,~     cytokines and cells and To compare between the above data regarding possible proteins,~     cytokines and cells, in regard to their possible effect on scarring and wound healing.~      Also to Identify those components which are present only in the cryosurgery blister and~     which might have an anti-scarring effect and to characterize them biochemically.~   "
109135|NCT01627756|"~     Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response.~     The investigators examined whether continued mechanical ventilation during CPB alters~     systemic immune activation.~   "
109136|NCT01627743|"~     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily~     clinical practice, the possible corelation between patIent perception of the ability to~     perform morning activities and physician evaluation; patients with COPD, grade C and D.~   "
109137|NCT01627730|"~     This research work develops a diagnostic and feedback-providing system for self-learning by~     volunteers who are asked to log in to a website to study the required subjects in three~     weeks.~      The system establishes students' learning weaknesses and offered guidelines for their~     improvement until all such weaknesses are corrected.~      Assessment is based on students' relative growth scores, and their record profiles.~   "
109150|NCT01627561|"~     The current study will evaluate the immunogenicity and safety of Cervarix when administered~     according to a 2-dose schedule with or without co-administration of GSK Biologicals' MMR and~     DTPa vaccines in 4-6 years old female subjects as compared to the standard 3-dose schedule~     in 15-25 years old female subjects, the population in which the clinical efficacy has been~     demonstrated.~   "
109151|NCT01627548|"~     A pilot intervention of an existing intervention adapted for the returning warfighter~     population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which~     emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.~   "
109152|NCT01627535|"~     This clinical trial studies optical imaging in assessing activity during surgery in patients~     with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally~     remove brain tumors and minimize damage to normal brain.~   "
109138|NCT01627717|"~     Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission~     modes. Near 20% of people living with HIV are also infected by HCV. People living with HIV~     are treated by anti-HIV medications that may interact with numerous other medications,~     including new medications against HCV.~      Boceprevir is one of these new HCV medications and it is now considered as part of the~     standard of care for people infected with HCV. Previous research has shown boceprevir may~     influence the capacity of the liver to breakdown (metabolize) certain medications and when~     these medications are used in combination with boceprevir, their blood concentrations may be~     increased or decreased which could increase the risk of side effects or decrease efficacy.~     Among the drugs having a potential for an interaction with boceprevir is maraviroc, an~     anti-HIV medication. If concentrations of maraviroc increase, people may experience more~     side effects. However, if concentrations of maraviroc decrease, people living with HIV may~     have a lower suppression of the virus. This could increase the risk for the HIV virus to~     develop resistance, that is that the treatment will no longer be effective. No studies have~     been conducted to investigate the effects of boceprevir on blood concentrations of~     maraviroc. This research project addresses this research question. This project, however,~     cannot be done with people living with HIV since resistance may develop in these people if~     the concentrations of maraviroc decrease. It is for this reason that the investigators wish~     to recruit healthy people not infected with HIV nor HCV.~      Eleven healthy volunteers will be included. They will receive maraviroc 150 mg (1 tablet)~     every 12 hours from days 1 to 19 inclusively. On day 5, a total of ten blood samples will be~     drawn during the following 12 hours (at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours after~     maraviroc morning dose intake) to measure the blood concentrations of maraviroc. Boceprevir~     800 mg (4 capsules) every 8 hours with food will be started on day 6 and continued until day~     19 inclusively. On day 19, after the morning maraviroc and boceprevir dose, another ten~     blood samples will be drawn over a 12 hour period. A phone follow-up will be done on day 26.~     Thus, the total study duration for subjects is 26 days. The investigators will compare the~     blood concentrations of maraviroc when given alone to the blood concentrations of maraviroc~     when given with boceprevir.~   "
109139|NCT01627704|"~     Compare the response rate after 6 months of hormone treatment (or a major change in hormone~     treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions~     taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in~     patients with all metastases taking up FES prior to treatment.~   "
109140|NCT01627691|"~     The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve~     System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe~     calcific aortic stenosis who are considered high risk for surgical valve replacement.~   "
109141|NCT01627678|"~     Background:~      Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which~     control the HIV infection and results in increases in CD4 cell counts and an undetectable~     viral load, many patients suffer from increased morbidity. There is evidence that presence~     of antibodies against the C5 region of gp120 strongly correlates with slower disease~     progression, and that loss of antibody responses to this region are associated with~     progression.~      Investigational product:~      Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the~     C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a~     non-neutralizing antibody against C5 region.~      Study objectives:~        1. To evaluate safety of the vaccination regimens~        2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell~          activation markers and other immune markers.~   "
109142|NCT01627665|"~     The study will address the impact of genetical variation of a protein involved in the~     intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.~   "
109143|NCT01627652|"~     This scientific study aims at studying human adaptations to high altitude and the studies~     will be conducted at the University of Zürich and during a 4 week high altitude expedition~     to the Jungfraujoch research station at 3450 m altitude. The proposal is made up of several~     independent biological research projects to be conducted in the same healthy volunteers~     participating in the study. Thus, the subjects will be studied at sea level, and then during~     4 weeks of acclimatization to high altitude, and for some experimental purposes all subjects~     will also be studied one and two weeks after return to sea level.~   "
109144|NCT01627639|"~     The purpose of this study is to determine whether acetazolamide are effective to reduce the~     length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease~     (COPD) patients developing pure or mixed metabolic alkalosis.~   "
109145|NCT01627626|"~     The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective~     dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic~     patients.~   "
109146|NCT01627613|"~     The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid~     clearance in ALI (acute lung injury) patients with the purpose to assess the treatment~     associated changes of extravascular lung water (EVLW) within 7 days of treatment.~   "
109147|NCT01627600|"~     The aim of the Atahualpa project is to evaluate the cardiovascular (CVH) status of the~     inhabitants of a rural village of coastal Ecuador as well as to determine the prevalence and~     retrospective incidence of stroke and ischemic heart disease. The protocol may be used as a~     pilot for large-scale studies attempting to evaluate the CVH of rural or even urban centers~     of Latin America, to implement cost-effective strategies directed to reduce the burden of~     stroke and cardiovascular diseases in the population at large.~   "
109148|NCT01627587|"~     This is a two part study. Part A of the study will evaluate the metabolites of GSK221149~     following single and repeat oral dosing and will also assess the pharmacokinetics of~     GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study~     will look at the pharmacokinetics of GSK221149 following a high fat meal.~   "
109149|NCT01627574|"~     The long-term objectives of this research are to develop effective treatments to reduce~     unplanned pregnancy and Sexually transmitted infections (STIs) for a highly under-served~     population in great need.~      This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve~     contraceptive use and decrease STIs for girls involved with the justice system for both~     those who do and do not want a pregnancy. Those interested in becoming pregnant will be~     counseled in the risks associated with teen pregnancy and what it means to have a healthy~     pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island~     to provide reproductive health services in the community. The investigators will recruit 250~     girls from juvenile probation and randomize them to two interventions: two sessions of~     personalized MI combined with one session of skill building or three sessions of Didactic~     Educational Counseling (DEC), both delivered individually by trained counselors. CAMI is~     based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically~     supported counseling technique designed to enhance readiness to change targeted behaviors.~     The DEC provides didactic information about contraception, STI prevention and abstinence,~     and is intended to control for the effects of assessment and attention.~   "
109546|NCT01622361|"~     The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy~     versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and~     HER2 negative, lymph node positive, primary breast cancer in premenopausal women.~   "
109153|NCT01627522|"~     Preoperative use of finastride will decrease the amount of perioperative blood loss during~     and after TURP~      The effect of finastride on decreasing the amount of perioperative blood loss during and~     after TURP is dose dependent~      Finastride will decrease microvascular density in prostate tissue and this effect is dose~     dependent~   "
109154|NCT01627509|"~     Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways~     :~        -  as Basal/bolus therapy (B/B) in four-five injections per day .~        -  as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control~          is achieved, the more likely patient would suffer from hypoglycemic episodes. We~          propose that the probability of hypoglycemia and its severity has no difference in two~          main insulin therapy schemes mentioned above.~      The objective of the study is to compare the incidence of hypoglycemia and its severity in~     well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different~     regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free~     Style Navigator).~   "
109155|NCT01627496|"~     The aim of this study is to determine the nutritional status, and factors affecting~     malnutrition in older people staying in hospitals.~      Objectives:~        -  To recruit a sample of older people in hospital~        -  To collect information on nutritional status, satisfaction with food-related life and~          experience with access to food in hospital.~        -  To assess the staffing attitudes to nutritional care of the older adult~        -  To undertake an audit of therapeutic ('special') diets served in hospitals, with~          respect to their nutritional adequacy and wastage~        -  To investigate predictors and correlates of malnutrition within the hospital setting~          and compare these relationships with those previously identified in care homes and the~          community.~        -  To make recommendations for practice to improve the nutritional status of hospitalised~          older adults.~   "
109156|NCT01627483|"~     The aim of this study is to investigate if prescribing of fall-risk increasing and~     fracture-preventing drugs can be improved in older hip fracture patients by assessments of~     risks of falls and fractures and medication reviews performed by a physician and forwarded~     to prescribing physicians.~   "
109157|NCT01627470|"~     The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring~     (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a~     transport in the ambulance car.~      Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP~     and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important~     factor of CNAP system performance is its ability to accurately track blood pressure changes.~     Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls~     within the expected range and that blood pressure alterations are detected instantaneously.~      The endpoints of the study are:~        -  The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a~          beat-to-beat basis during:~        -  Takeover of the patient on the intensive care unit,~        -  Transport of the patient from the intensive care unit to the ambulance car~        -  Transport of the patient in the ambulance car~        -  The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes~          determined on a beat-to-beat basis during:~        -  Takeover of the patient on the intensive care unit,~        -  Transport of the patient from the intensive care unit to the ambulance car~        -  Transport of the patient in the ambulance car~      The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a~     memory card in the transport monitor. CNAP data will additionally be recorded directly on~     the CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as~     well as adverse events (AE) recording.~   "
109158|NCT01627457|"~     In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility~     of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease~     patients who participate in cardiac rehabilitation training exercise at the rehabilitation~     clinic (phase II) and subsequently at home (phase III). The GEx system consists of a~     easy-to-wear vest with integrated electrodes to measure electrocardiogram (ECG), respiration~     and activity, furthermore of a PDA to collect and store the monitored data and a cradle to~     charge the batteries. Several physiological parameters are extracted from thes measured~     vital signs like heart rate, breathing rate, ECG and activity. In this pretrial first the~     GEx sensor system is validated during guided exercise of the patients in the rehabilitation~     clinic (phase II). Subsequently at home (phase III) the practicability of the vest and~     sensors and possible technical problems in real- life use are proved. This means after~     moderate training like walking, cycling or running at home for 3 weeks patients will report~     the feasibility of usage. The ECG data and breathing- frequency data will be analyzed to see~     if data are recorded and transmitted well in regard to technical problems.~   "
109159|NCT01627444|"~     Does ear acupuncture reduce anxiety in mother of very low birth weight infants?~   "
109160|NCT01627431|"~     The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and~     its prevalence increase with age and with the simultaneous presence of cardiovascular risk~     factors.~      PAD patients are usually treated, as a first line treatment, with the exercise therapy,~     combined with the pharmacological antiplatelet therapy.~      In the case of first line therapy failure, PAD patients usually undergoing to invasive~     revascularization procedures.~      After a peripheral stent has been located, the major follow-up problem is the restenosis~     rate.~      Published studies describe how, in a large amount of patients, can be recognised an high~     residual platelet activity. These data about PAD patients at the moment are lacking .~      The authors would evaluate the incidence of PAD patients with an high residual platelet~     activity.~   "
109161|NCT01627418|"~     Aim~      The purpose of this study is to evaluate whether fuel subsidies reduce exacerbations of COPD~     among people aged over 55, and therefore whether providing such subsidies is a~     cost-beneficial policy initiative.~      The Warm Homes for Elder New Zealanders Study enrolled community-dwelling people aged over~     55 with moderate or worse COPD. Prior to the study commencing the houses were insulated (if~     feasible, & the house-owner agreed). Data were collected on the health and energy use of the~     participants.~      The households randomly assigned to the early intervention group had a subsidy to their~     power account their first winter in the study. The subsidy was the intervention and was~     designed to enable the participants, if they chose to do so, to keep their house warmer~     during the winter.~   "
109162|NCT01627392|"~     The purpose of the study is to learn more about tobacco dependence and nicotine metabolism~     in African-Americans and whites, by studying to see if how fast a person metabolizes~     nicotine (how the body breaks down nicotine into inactive compounds) affects how dependent~     they are on smoking cigarettes. The investigators believe that people with a faster rate of~     metabolism may have more severe nicotine withdrawal symptoms and also may have a harder time~     trying to quit smoking.~   "
109163|NCT01627379|"~     More than 50% of patients with esophageal cancer have locally advanced or metastatic disease~     at presentation. The use of chemotherapy for this patient group is increasing with the~     intention of local and distant tumor control, improving quality of life and prolongation of~     survival.~      Previous data suggested not only that EGFR antibody targeted therapy may be safely combined~     with cisplatin and 5-FU but also may increase the efficacy of standard cisplatin / 5-FU~     regime.~      In the present study, patients with nonresectable, advanced or metastatic esophageal~     squamous cell cancer (ESCC) will receive chemotherapy or chemotherapy plus panitumumab every~     3 weeks until disease progression occurs.~      The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over~     5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.~   "
109164|NCT01627366|"~     Improvements in early detection and successful treatment of breast cancer have lead to a~     steady rise in the number of breast cancer (BC) survivors. With so many individuals living~     for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the~     implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to~     improve ongoing clinical and coordination of care, and to address the immediate~     post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial~     burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the~     American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have~     been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844).~     This will be one of the first randomized controlled trials to test the efficacy of TSSPs.~      The investigators will recruit 500 low income, medically underserved women from two county~     public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after~     breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to~     test the efficacy of TSSPs. The investigators will randomize these women into one of two~     groups: 1) a control condition of usual medical care and 2) an experimental condition of the~     control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all~     cancer specialists and primary care physicians of record also receiving the TSSP and a cover~     letter suggesting how they can be clinically utilized.~      The investigators specific aims are to assess and compare between experimental and control~     groups the following primary outcomes at one year post-intervention: 1) discussion and~     implementation of recommended breast cancer survivorship care, including surveillance and~     the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with~     survivorship communication and care, 3) pertinent aspects of health-related quality of life,~     and further, to then 4) assess the cost-consequences of the experimental intervention. This~     study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income,~     underserved population of BC survivors known to be at high risk for poorer long-term~     outcomes, including in mental health, quality of life, recurrence and mortality, and will~     therefore allow us to demonstrate the greatest possible benefit of such an intervention.~   "
109165|NCT01627353|"~     The study is a blinded randomized clinical trial, comparing policies of high volume~     preemptive wound infiltration with a specific anesthetic cocktail versus standard of care~     (no wound infiltration and routine anesthesia) for post operative pain management after~     hysterectomy. Morphine use and pain will be measured during index admission, and pain will~     also be measured six weeks postoperatively. The study will be conducted at a single site,~     Rockyview General Hospital.~   "
109166|NCT01627340|"~     This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine)~     when administered as a primary vaccination course at 0, 1 and 6 months in adults with or~     without type 2 diabetes mellitus.~   "
109167|NCT01627327|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone~     Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide~     inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who~     have or are at risk for co-morbid cardiovascular disease~   "
109168|NCT01627314|"~     This study is an open-label randomized, prospectively and historically controlled trial of~     the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant~     following myeloablative or reduced intensity conditioning for subjects age 15-65 years with~     hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in~     the trial at approximately 10 centers within the U.S.~   "
109169|NCT01627301|"~     Patients with post-traumatic stress disorder (PTSD)and prehypertension (borderline high~     blood pressure) are at higher risk for developing high blood pressure and heart disease. The~     purpose of this study is to test whether PTSD patients have exaggerated increases in blood~     pressure, heart rate, and adrenaline levels during different forms of stress, that might~     predispose them to developing high blood pressure and heart disease. This study will also~     evaluate whether regular sessions of slow breathing that is guided by a device (RESPeRATE)~     improves blood pressure, heart rate, and adrenaline levels during stress in patients with~     PTSD and prehypertension.~   "
109170|NCT01627288|"~     The purpose of this study is to determine the maximum tolerated dose of integrated boost~     radiation therapy when given with concurrent chemotherapy (cisplatin).~   "
109171|NCT01627275|"~     Allogeneic stem cell transplantation offers the hope of cure for a wide variety of~     hematologic malignancies. Mature donor T-cells play a critical role in the success or~     failure of this procedure and a subset of donor T-cells mediate graft-versus-host disease~     while other subsets provide the foundation for immune recovery. The major challenge in~     allogeneic stem cell transplantation is determining how to maximally exploit the beneficial~     effects mediated by T-cells without causing GvHD. This challenge could be overcome by~     selectively depleting the population of donor T-cells responsible for eliciting the GvHD~     response. The study hypothesis is depletion of naïve T-cells from the donor lymphocyte~     inoculum will not cause GVHD while providing T-cells to affect both anti-infection and~     anti-tumor responses.~   "
109172|NCT01627262|"~     The purpose of this study is to determine whether mesalamine is effective in the treatment~     of uncomplicated diverticular disease by reducing the pain.~   "
109186|NCT01627080|"~     The goal of this clinical research study is to learn if the radiation that you will receive~     for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.~      When cardiac biomarkers are above normal levels, there may be heart damage. The relationship~     between cardiac biomarkers and radiation therapy has not been well studied. Learning more~     about this relationship may lead to better ways to check the heart during radiation therapy~     and predict heart problems.~   "
109547|NCT01622348|"~     The purpose of this study is to evaluate different dose levels of IMO-3100 compared to~     placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.~   "
109173|NCT01627249|"~     Although multiple studies have suggested that treatment with ranibizumab is safe and~     efficacious and superior to focal/grid laser alone for patients with center-involved~     diabetic macular edema (DME), there may be barriers in place to widespread adoption of~     ranibizumab use given its high cost per dose and the need for multiple treatments over time.~     Prioritizing resources from a public health policy perspective could be easier if more~     precise estimates regarding the risks and benefits of other anti-vascular endothelial growth~     factor (anti-VEGF) therapies were available, especially when the difference in costs could~     be billions of dollars over just a few years. Thus, there is a clear rationale at this time~     to explore potential anti-VEGF alternatives to ranibizumab that might prove to be as or more~     efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost~     substantially less. Of the potentially available alternative anti-VEGF agents for this~     trial, bevacizumab and aflibercept are the best candidates for a direct comparison study.~     Bevacizumab shares the most similar molecular structure, costs far less, and is widely~     available. Furthermore, there is already preliminary evidence to suggest that it may be~     efficacious in the treatment of DME and it is already being widely used for this indication.~     Although aflibercept has a similar cost per unit dose to ranibizumab, it has the potential~     to decrease treatment burden and associated cost. If results from a comparative trial~     demonstrate improved efficacy or suggest similar efficacy of bevacizumab or aflibercept over~     ranibizumab, this information might give clinicians scientific rationale to substitute~     either one of these drugs for ranibizumab in the treatment of DME, and might thereby have~     substantial implications for public policy in terms of future estimates of health care~     dollars and possibly number of treatments necessary for anti-VEGF treatment of diabetic~     macular disease.~      Because of its availability and lower cost, bevacizumab is already currently in widespread~     clinical use for treatment of DME despite the lack of FDA approval for this indication.~     Thus, a clinical trial that suggested whether bevacizumab could be used as a safe and~     efficacious alternative to ranibizumab could substantially impact nationwide practice~     patterns for treatment of DME by either validating the current use of bevacizumab or by~     demonstrating improved outcomes with ranibizumab or aflibercept treatment for DME.~      Study Objective The primary objective of the proposed research is to compare the efficacy~     and safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3)~     intravitreal ranibizumab when given to treat central-involved DME in eyes with visual acuity~     of 20/32 to 20/320.~   "
109174|NCT01627236|"~     The investigators will investigate the clinicopathological features of chronic hepatitis B~     patients with severe exacerbation selected by uniform criteria, and treated with early~     introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to~     clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic~     therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The~     investigators also observe the immune index in the change before and after the treatment, in~     order to searching for some prognostic index.~   "
109175|NCT01627223|"~     This is a prospective, observational, open-label, 2-arm, parallel, multi-center study.~     Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI~     (such as lamivudine and entecavir) is medically recommended will be screened for~     eligibility. To target 74 evaluable subjects, approximately 82 patients should be recruited~     into this trial. After enrollment, all eligible subjects will be randomly assigned to one of~     the antiviral treatments below.~        -  Cohort 1: Lamivudine 100 mg p.o. q.d.~        -  Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, <~          4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and~          the first dose of observational drug should be administered on Day 1. The observational~          period of individual subject will be 12 weeks; however, both treatments could be~          continued after the end of study based on physician's clinical judgment.~      The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180~     days after initiation of antiviral treatment. All assessments should be conducted based on~     routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be~     performed in the central lab. For patients who are willing to provide the residual samples~     of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE~     will be followed until resolution or the event is considered stable.~   "
109176|NCT01627210|"~     This is a prospective, non-randomized, observational study conducted in the United States.Up~     to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term~     utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will~     be followed monthly over a period of one year.~   "
109177|NCT01627197|"~     Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients~     cystectomized for locally advanced bladder cancer.~   "
109178|NCT01627184|"~     The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as~     well as system performance during high levels of activity and home use by adult athletes~     with insulin-requiring diabetes mellitus, over an extended period of time.~   "
109179|NCT01627171|"~     Colonoscopic examinations are performed routinely in hospitalized patients for a variety of~     indications. However, numerous limitations exist in hospitalized patients preventing an~     endoscopist from performing high quality examinations; possibly necessitating repeated~     procedures leading to increased cost and re-exposure to their inherent risks. One such~     prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown~     to be a predictor of poor bowel preparation as these patients are older, less mobile and~     have more co morbidities than the outpatient population. Currently, no standardized (or~     optimized) bowel preparation type or regimen for administration exists for the hospital~     inpatient population undergoing colonoscopy. Studies in the outpatient population have~     demonstrated that timing and choice of cathartic medication effects the cleanliness of the~     bowel preparation but there is no such clinical evidence for in-patients who receive~     whatever cathartic agent is on hospital formulary. The purpose of the study is compare~     efficacy, patient satisfaction, and adverse effects associated with low volume cathartic~     (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate~     timing of dosages.~   "
109180|NCT01627158|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler~     with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the~     bloodstream.~   "
109181|NCT01627145|"~     Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for~     Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With~     Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient~     Perception of Bladder Condition.~   "
109182|NCT01627132|"~     The purpose of this study is to assess whether dasatinib can be discontinued without~     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase~     in complete molecular remission (CMR) while on dasatinib.~   "
109183|NCT01627119|"~     For the past 50 years, gastric cancer has been one of the ten most frequent cancers and the~     second leading cause of cancer-related death in the world. In Taiwan, it is the fifth most~     common cause of cancer-related deaths, accounting for 6.3% of all cancer deaths. The poor~     prognosis of gastric cancer is mostly caused by the extensive metastasis to the lymph nodes,~     liver, and peritoneal dissemination even if curative resection was performed. The main cause~     of recurrence after curative or noncurative resection of advanced tumors is peritoneal~     metastasis because of possible direct spillage and dissemination of tumor cells as a result~     of surgical manipulation, and it is associated with a poor prognosis. As yet, no effective~     treatment has been developed for this condition. The development of peritoneal metastasis is~     a multistep process, beginning with attachment to peritoneal mesothelial cells, retraction~     of the mesothelial cells and exposure of the basement membrane, attachment to the basement~     membrane, degradation in the extracellular matrix, proliferation by the cancer cells, and~     angiogenesis, and it is clear that many types of agents are involved at the various stages~     of this process. Developing a new therapeutic method for this mode of metastasis is very~     important for improvement of gastric cancer treatment.~      CTGF is a secretory protein belonging to the CCN family (one among the three originally~     discovered members: cysteine-rich61, CTGF, and nephroblastoma-overexpressed gene). It is a~     multifunctional growth factor involved in wound healing, inflammation, cell adhesion,~     chemotaxis, apoptosis, tumor growth, and fibrosis. Recent studies showed that overexpression~     of CTGF in human oral squamous cell carcinoma reduces cell growth and tumorigenecity.~     Similar tumor growth inhibitory effects were observed in lung cancer cells in which CTGF~     overexpression was less angiogenic and metastatic due to blocking of the VEGF A signaling~     pathway. CTGF was also reported to be a key regulator of colorectal cancer invasion and~     metastasis, and it appears to be a better prognostic factor. These studies suggest that CTGF~     may involve the processes of peritoneal metastasis which includes cancer cell adhesion in~     peritoneum, proliferation and angiogenesis. Peritoneal mesothelium is the first surface~     encountered by disseminated tumor cells and successful adhesion is, therefore, of paramount~     importance in metastasis formation. Therefore, we hypothesized that CTGF is a potential~     molecule target, which may be related to cell adhesion to peritoneum, the first step of~     peritoneal metastasis, and its exact mechanism may includes proliferation and angiogenesis.~      In order to answer these important questions, first, we have performed the preliminary~     studies to prove CTGF did express in different gastric cancer cell lines including AGS, N87,~     TSGH, and MKN-45 by using RT-PCR and Western blotting, and gastric cancer tissues by using~     immunohistochemical method. Second, we demonstrated different levels of CTGF expression in~     different cell lines pose different adhesion ability in in-vitro adhesion assay. Third, we~     conducted a transient CTGF-overexpressed MKN45 gastric cancer cell line, and~     CTGF-overexpressed cell line had lower adhesive ability compared to the control.~      Next step in this project, we will be studying the roles of CTGF plays in cellular and~     molecular biology in vitro and in vivo and clinical significance associated with therapeutic~     potential of peritoneal metastasis from gastric cancer. We will generate stable clones of~     MKN45 cells harboring CTGF and its control cell line to elucidate the roles of CTGF in~     cancer cell adhesion, proliferation and angiogenesis in peritoneum.~   "
109184|NCT01627106|"~     This study will compare vernakalant therapy to amiodarone therapy in the acute management of~     recent onset atrial fibrillation.~   "
109185|NCT01627093|"~     The goal of this data review research study is to collect medical record information from~     patients with head and neck cancer that have received or are scheduled to receive proton~     therapy at MD Anderson. Researchers will study the medical record information to try and~     improve therapy for future patients with head and neck cancer.~   "
109187|NCT01627067|"~     The goal of this clinical research study is to learn if exemestane and everolimus combined~     with metformin can help to control breast cancer in patients who are obese or overweight and~     post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts~     of the body.~      Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This~     could cause the cancer cells to die.~      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is~     designed to lower insulin levels, which may slow or stop the growth of breast cancer cells.~      Everolimus is designed to block cells from dividing. This may cause cancer cells to die.~     Everolimus may also stop the growth of new blood vessels that help tumors grow.~   "
109188|NCT01627054|"~     The purpose of this study is to find out what effects a new drug AT7519M has on chronic~     lymphocytic leukemia.~   "
109189|NCT01627041|"~     This randomized phase II trial studies how well decitabine works when given together with~     daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia.~     Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine~     kill more cancer cells by making them more sensitive to the drugs. It is not yet known~     whether low-dose decitabine is more effective than high-dose decitabine when giving together~     with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.~   "
109190|NCT01627028|"~     To investigate the skeletal effect of Thai traditional massage by examining the changes in~     biochemical markers of bone turnover.~   "
109191|NCT01627015|"~     In this study, the safety, acceptance and metabolic effects in infants receiving a novel low~     glycaemic index follow-on formula will be investigated.~      After 4 week intervention period, metabolic response after feeding is significantly~     different between a follow-on formula containing low glycaemic carbohydrate and a~     conventional follow-on formula containing higher glycaemic carbohydrates.~   "
109192|NCT01627002|"~     The purpose of this study is to examine the safety, tolerability, immunogenicity and the way~     the body absorbs, distributes, breaks down and excretes various increasing single and~     multiple subcutaneous doses of PA401 in healthy subjects.~      This study will also look at the effect of PA401 on inflammation in the lungs following an~     inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and~     sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single~     subcutaneous dose of two dose levels.~   "
109193|NCT01626989|"~     Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining~     if the new device will treat those participants no worse than when compared to its~     predecessor device.~   "
109194|NCT01626976|"~     This is the first-in-human study for an oral investigational compound, PF-06282999, in order~     to assess its safety, tolerability and pharmacokinetics in humans across a wide range of~     dose levels.~   "
109195|NCT01626963|"~     Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal~     resections, due to it's short-term benefits over conventional open surgery. In recent years,~     several studies have demonstrated that - in suitable patients - single-port access surgery~     (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It~     remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.~      In this study, the investigators aim to randomise patients who are deemed suitable for SPA~     surgery to either SPA approach, or CL; in addition to clinical outcomes including length of~     operating time, post-operative pain scores, complications, quality of life indicators and~     cosmetic appearance, the investigators aim to compare the physiological response to trauma~     through biochemical markers (including C-reactive protein, White Blood Cell count) and~     cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according~     to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group.~     The patients will be operated by surgeons proficient in both CL and SPA surgery, and~     followed-up for the duration of their hospitalisation as well as at their routine~     out-patient visits, using questionnaires.~   "
109196|NCT01626950|"~     The main objective of this study is to estimate of the link (odds ratio) between the~     precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at~     diagnosis (2 groups: CAS: stages 1 or 2 the good prognosis versus the witnesses: stage 3~     or 4 bad prognosis).~   "
109197|NCT01626937|"~     Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to~     only standard medical treatment, might enable a decrease in intubation rate.~      Primary end point: the rate of endotracheal intubation in the first three hours after~     randomization.~      Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital~     and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart~     rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30~     days mortality, delays between first medical contact and in-hospital admission, relation~     between initial pH level and endotracheal intubation.~      Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and~     presenting acute respiratory decompensation with respiratory acidosis.~      Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract~     haemorrhage, shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure,~     serious cranial-facial trauma, upper airways obstruction, undrained pneumothorax,~     uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea~     < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic~     tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment.~      Randomization: Assignment to NPPV group or standard therapy group will be performed at the~     time of arrival of the SAMU team to the patient, by calling a physician located at the~     calldispatch center who will connect to the web site of the clinical research unit from~     Bordeaux university hospital.~      Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up).~      Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%,~     power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%).~      Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre~     Hospitalier Saint-Esprit - Agen.~      Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.~   "
109219|NCT01626651|"~     The purpose of this study is to assess the potential effects of ketoconazole on the~     pharmacokinetics of ibrutinib in healthy participants.~   "
109220|NCT01626638|"~     The primary objective is to validate the diagnostic correlation between the intraoperative~     microendoscopic images and the conventional histological analysis on biopsy and/or surgical~     specimens on patients with epidermoid carcinoma.~   "
109221|NCT01626625|"~     The investigators hypothesized that mesenchymal stem cells can be isolated from fracture~     site, iliac crest, and tibial crest, and can be expanded to be used in the management of~     nonunion fracture.~   "
109198|NCT01626924|"~     In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia),~     toxic compounds will be formed. These toxic compounds will damage the cells of the brain. 2~     Iminobiotin (2 IB) is an investigational medicinal product that is related to vitamin B7.~     From studies in animals it has been shown that 2-IB may prevent the formation of the toxic~     compounds. Also it has been shown to be safe in in studies in juvenile animals and in~     healthy, adult male volunteers. The doctors hope that this will prevent (part of) the~     potential brain damage that may result from lack of oxygen to the brain.~      This study is the first study in the target population: newborn with moderate to severe~     oxygen shortage during birth. In this study the investigators evaluate short term efficacy,~     safety and pharmacokinetics of 2-Iminobiotin. In the follow-up phase the investigators~     evaluate the long term efficacy and safety.~      The study hypothesis is that 2-Iminobiotin will help to decrease the brain damage after~     oxygen shortage and is indeed safe. The brain damage will be measured both in the first week~     and during the first two years of life. The study was designed as a study with two parts an~     open label pilot part (6 patients) and a double-blind randomised part (60 patients). Due to~     lack of recruitment it was decided in September2014 to stop recruitment after the open label~     pilot part of the study (6 patients).~   "
109199|NCT01626911|"~     Our animal studies found that continuous regional arterial infusion (CRAI in the celiac~     trunk) of low molecular weight heparin (LMWH) could alleviate inflammation, improve global~     hemodynamics and restore organ function in a porcine model of severe acute pancreatitis~     (SAP,unpublished).~      In this study, the investigators aim to evaluate the effects of CRAI of LMWH in the~     treatment of SAP patients. The investigators suppose CRAI could help improve the outcomes of~     these patients.~   "
109200|NCT01626898|"~     Wake Forest University is partnering with Chatham Social Health Council (a community-based~     organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres~     Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups),~     a Spanish-language HIV risk behavior intervention for Latino men who have sex with men (MSM)~     in rural North Carolina.~      Participants in the HOLA intervention, when compared to those in the comparison~     intervention, will report: increased consistent use of condoms during sexual intercourse;~     increased use of HIV and sexually transmitted disease (STD) counseling, testing, and~     treatment services; greater knowledge concerning the impact of HIV on communities (including~     Latino and MSM)and HIV risk behaviors and prevention strategies; more positive attitudes~     towards abstinence and condom use; increased self-efficacy to use and assert the use of~     condoms with sex partners; increased condom-use mastery scores; decreased barriers to risk~     reduction (e.g. health-compromising aspects of machismo); and enhanced partner and provider~     communication and sexual negotiation skills.~   "
109201|NCT01626885|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with receiving multiple drugs schizophrenia.~   "
109202|NCT01626872|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with schizophrenia.~   "
109203|NCT01626859|"~     The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of~     MP-214 in patients with schizophrenia.~   "
109204|NCT01626846|"~     The study will seek to determine whether there is a corresponding deficit in school~     performance for teenagers with NF1. Secondly, the study seeks to explore the issue of~     self-esteem in teenagers with NF1.~   "
109205|NCT01626833|"~     Anorexia nervosa may be responsible for a catch- down or even an interruption of growth,~     delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of~     normal nutrition usually leads to a resumption of growth and pubertal development. However,~     despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients~     have a significant short stature with reduced adult final height and a deficit of bone mass.~     The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth~     velocity in prepubertal children or children in early puberty with anorexia nervosa and~     significant reduction of height velocity. This is a single-center, controlled, randomized~     and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against~     a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia~     nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment~     in children receiving placebo and continued hGH treatment in the treatment arm for 1 year,~     in total 2 years of study for each child. This second period corresponds to an ethical~     consideration giving secondarily access to treatment for patients in the placebo group.~   "
109206|NCT01626820|"~     This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition~     (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and~     safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.~   "
109207|NCT01626807|"~     Just two generations ago, walking or bicycling to school was the norm for a substantial~     number of US children, e.g. 48% of children walked or biked to school in 1969 versus only~     13% in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic,~     which is at record high levels in the US and affects low-income and ethnic minority children~     the most. This project will test the walking school bus (WSB) program, in which children~     walk to and from school with adults, and its impact on low-income, ethnic minority~     children's walking to school, physical activity, and risk for obesity. Ultimately, this line~     of research has the potential to provide a low-cost, easy to disseminate program to reduce~     risk of obesity and cancer for at-risk children.~      The investigators Specific Aims among 3rd-5th grade children include:~      SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a~     cluster randomized controlled trial to assess the efficacy of a WSB program on children's~     walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and~     analyze data on individual-, school-, and macro-level influences on changes to children's~     walking to school resulting from the WSB program~      The Primary Hypotheses to be tested, in comparison to control children, include:~      H1) The WSB program will increase children's walking to school over a school-year.~      H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between~     the WSB and changes to children's walking to school.~      H1b) Walkability, safety, and acculturation will moderate changes to children's walking to~     school.~      H2) The WSB program will increase children's physical activity and decrease BMI z-scores~     over a school-year.~      H3) The WSB program will increase school-level pedestrian safety behaviors over a~     school-year.~   "
109208|NCT01626794|"~     This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured~     with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The~     primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV)~     antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6~     weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody~     response rate at 6 weeks after vaccination 1.~   "
109209|NCT01626781|"~     The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as~     prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with~     gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.~      Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS.~     Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced~     HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the~     same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should~     result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream~     was selected for the standard arm, because it is used commonly, is accepted by patients, and~     seems to have a positive influence on the severity of the HFS in the experience of many~     oncologists.~   "
109210|NCT01626768|"~     The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study,~     multi-center clinical investigation.~      The purpose of this clinical investigation is to collect high quality medical images of the~     Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the~     study will allow for lead design and testing processes better tailored to the implanted~     environment.~   "
109211|NCT01626755|"~     Phantom limb pain following amputation is a major problem. Current evidence how to best~     prevent phantom limb pain is equivocal because previous trials have included small numbers~     of patients, and tested heterogeneous patient collectives. There is some evidence that~     optimized perioperative pain control is effective in preventing phantom limb pain, but the~     potential added role of regional anesthesia has not been defined.~      Objective:~      The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point~     prevalence of phantom limb pain 12 months after transtibial amputation for peripheral~     vascular disease compared to optimized intravenous pain therapy.~      Study design:~      Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All~     patients will receive standard optimized intravenous anesthesia and analgesia (opiate~     patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention~     group will receive additional infusion of local anesthetic via a sciatic nerve catheter~     placed under ultrasound guidance.~      Main outcome of this study:~      Point prevalence of chronic phantom limb pain after 12 months.~   "
109212|NCT01626742|"~     Evaluate effects of an oral nutritional supplement on healthcare outcomes in older~     hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned~     Readmissions and Survival in Hospitalized patients.~   "
109213|NCT01626729|"~     The U.S. food and beverage industry recently released a new front-of-package nutrition~     labeling system called Facts Up Front that will be used on thousands of food products. The~     purpose of this study was to test consumer understanding of the Facts Up Front nutrition~     labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up~     Front displays grams/milligrams and % daily value information for various nutrients; Traffic~     Light uses an interpretive color-coded scheme to alert consumers to low, medium or high~     levels of certain nutrients. Participants in an Internet-based study were randomized to one~     of five front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light~     plus information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up~     Front plus information about nutrients to encourage (Facts Up Front+). Total percentage~     correct quiz scores were generated reflecting participants' ability to compare two foods on~     nutrient levels, based on their labels, and to estimate amounts of saturated fat, sugar,~     sodium, fiber and protein in foods. 703 adult participants recruited through an online~     database in May 2011 participated in this Internet-based study and data were analyzed in~     June 2011. The investigators hypothesized that the Traffic Light label groups would perform~     better than the Facts Up Front groups on all outcomes.~   "
109214|NCT01626716|"~     Late-life depression is associated with physical limitations, greater functional impairment,~     increased utilization and cost of health care, and suicide. Collaborative care, linking~     primary and mental health specialty care, has been shown to be effective for the treatment~     of late-life depression in primary care settings in Western countries. The primary aim of~     this project is to implement a depression care management intervention, and examine its~     effectiveness on the depressive symptoms of older patients in Korean primary care settings.~     Based on chronic disease management theory and previous Collaborative care management~     studies in western countries, we propose to test a Depression Care Management~     intervention,which includes care manager to support a primary care physician of depression~     in their old patients. Care manager'd role are monitoring the progress of treatment,~     supporting patient's adherence, educating patients/ family and facilitate communication~     between providers. Also psychiatrists provide consultation and supervision of care managers.~     Using a randomized controlled design, we will examine whether the Depression care management~     is an effective treatment for patients with late life depression in rural Korea. The primary~     outcome would be the improvement of depressive symptoms of patients in primary care setting.~   "
109215|NCT01626703|"~     Depression affect between 5% and 10% of older adults seen in the primary care~     setting.Late-life depression is often chronic or recurrent and is associated with~     substantial suffering, functional impairment, and diminished health-related quality of~     life.Depressed, older primary care patients are frequent users of general medical services~     and may have poor adherence to medical treatments.They are also at increased risk of death~     from suicide and medical illnesses. The aim of this study is to examine whether depression~     screening and health care practitioner feedback are increased depression treatment rate.~      Depression screening is provided 60 or more who visited community health care center with a~     15-item Geriatric Depression Scale.GDS scores of 10 or more were classified depression~     positive. Intervention group participants received twice remind calls from primary care~     nurse.~   "
109216|NCT01626690|"~     The purpose of this study is to determine if placement of a forced-air warming device prior~     to institution of regional anesthesia improves perioperative temperature control in patients~     undergoing total hip arthroplasty.~   "
109217|NCT01626677|"~     This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®,~     human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or~     defects, compared with microfracture. Subjects who participated in and completed the Phase~     III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.~   "
109218|NCT01626664|"~     The purpose of this study is to estimate the overall response rate of subjects with relapsed~     or refractory Adult T-cell Leukemia-Lymphoma (ATL).~   "
109222|NCT01626612|"~     Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit~     patients. Early initiation of an appropriate empirical antimicrobial therapy is associated~     with improved outcomes. In order to avoid an increase of selection pressure and the~     emergence of multidrug resistant pathogens, guidelines recommend to streamline the~     antimicrobial therapy after the identification of the pathogen responsible for infection.~     This strategy has been evaluated in several observational studies. However, at the bedside,~     few randomized clinical trials tested this strategy prospectively.~      Method: the investigators conduct a randomized clinical trial comparing a strategy based on~     de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative~     strategy (continuation of the empirical antimicrobial therapy). The investigators first aim~     was to show that a strategy based on de-escalation is not inferior to a conservative~     strategy in terms of intensive care unit length of stay. Secondary aims are to compare the~     rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility~     of de-escalation. The study is performed in nine intensive care units from four~     institutions, and 120 patients are required to validate the investigators hypothesis. New~     technologies for the rapid diagnosis of severe infections are investigated in an ancillary~     study.~   "
109223|NCT01626599|"~     This study is designed to collect data to support development of a novel product designed to~     sense changes in heart rate or movement during periods of sleep in people with epilepsy.~     When a potential seizure is detected, the system sends out an audio-visual notification.~   "
109224|NCT01626586|"~     In this research study the investigators want more about how being in a group about diabetes~     helps your family versus individual treatment. The investigators are asking youth with~     diabetes and their parents to be in the research, because the investigators want to see if~     this diabetes group and/or individual therapy is helpful to your coping, adjustment, and~     family communication about diabetes.~   "
109225|NCT01626573|"~     This is a study evaluating a 28-day course followed by a 56-day course of INCB039110 in~     patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy~     parameters of INCB039110.~   "
109226|NCT01626560|"~     Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and~     IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative~     treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both~     groups according to levels of the cytokines evaluated.~   "
109227|NCT01626547|"~     The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients~     receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a~     multiple myeloma and who are treated with Retacrit™.~   "
109228|NCT01626534|"~     Ticagrelor is a new P2Y12 ADP receptor antagonist. This drug demonstrated a faster onset of~     action and a higher potency compared to clopidogrel standard regimen. Consistently these~     properties were associated in the PLATO trial, and particularly in the percutaneous coronary~     intervention (PCI) arm of the study, with a lower incidence of thrombotic complications at~     one year follow-up but at a price of increased major bleedings (7,8). The major finding of~     the trial was a significant reduction in one year mortality in patients treated with~     ticagrelor. This reduction in mortality may not be related to the anti-platelet effect of~     the drug since another potent anti-platelet agent which was recently commercialized a did~     not exhibit any improvement in death compared to clopidogrel. Therefore there may be non~     anti platelet directed properties, or pleiotropic effects, of ticagrelor that could be~     involved in a reduction in mortality in acute coronary syndrome (ACS) patients. In fact~     together with its anti platelet properties, ticagrelor, has been shown to inhibit the uptake~     of adenosine by red cells, leading to an increase in adenosine plasma level and then~     activating the low affinity adenosine receptor thus potentially affecting the vascular~     homeostasis including endothelial cells. Therefore, it is hypothesis that the side effects~     and its benefit on mortality may be related to its interaction with adenosine metabolism. In~     line with this hypothesis, some adverse effects of ticagrelor (bradycardia and modulation of~     bronchoconstriction) are compatible with the activation of low affinity A1 or A2A adenosine~     receptors.~      In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact~     the endothelial compartment during PCI (9). In fact the investigators have observed that the~     level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of~     endothelial damage during PCI. More potent anti platelet drugs such as ticagrelor may thus~     be associated with reduced peri-procedural endothelial lesion which could further improve~     the clinical prognosis of patients. The investigators have previously observed that~     endothelial marker of lesion and regeneration could be measured in the blood post PCI (10).~      Finally, in the response trial no patients in the ticagrelor arm had HTPR compared to 50% in~     the clopidogrel arm (7). This finding is surprising since recent data suggest that some~     patients still exhibit HTPR following the use of the very potent third generation~     thienopyridine prasugrel. This may be related to the fact that in the response trial only~     stable patients were included.~      The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of~     ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary~     intervention.~   "
109229|NCT01626521|"~     To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who~     require hospitalization. Specifically, to determine whether F1+2 may have an additional~     value in the subgroup of patients with an abnormal D-dimer,to determine whether it may~     increase the proportion of patients in whom PE can be safely ruled out and to determine the~     sensitivity, specificity and NPV of F1+2 at various cut-off values.~   "
109230|NCT01626508|"~     The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated~     breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution~     of the total content and plasma profile of essential fatty acids (EFA) in a population of~     premature infants.~   "
109231|NCT01626495|"~     This is a study for children who have been previously treated for Leukemia/Lymphoma. In~     particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B~     cells (a type of white cell), which contain the cancer. This is a new approach for treatment~     of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's~     white blood cells (T cells) and modify them in order to target the cancer.~      The subject's T cells will be modified in one or two different ways that will allow the~     cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells~     the T cells to go to the B cells (tumor cells) and turn on and potentially kill the B~     cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer,~     in order to allow the modified T cells to recognize your tumor cells but not other normal~     cells in the subject's body. These modified cells are called chimeric antigen receptor 19~     (CART19) T-cells.~   "
109232|NCT01626482|"~     Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the~     most investigated topics currently. However we do not know accurately the mechanisms that~     produce it.~      The aim of this study is to determine the influence of the Kinesio taping (KT) application~     in the paravertebral muscle fatigue in a sample of healthy young subjects.~   "
109233|NCT01626469|"~     The purpose of this study is to the determine the effect of salt intake and Captopril on the~     ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.~   "
109234|NCT01626456|"~     This study will evaluate the safety and durability of effect of ALKS 9072 (also known as~     ALKS 9070) during long-term treatment of subjects with stable schizophrenia.~   "
109235|NCT01626443|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of~     reproductive age and is characterized by menstrual abnormalities, clinical or biochemical~     hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often~     suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk~     of developing several metabolic disorders. Inositol is a six-carbon polyol which has been~     characterized as an insulin sensitizer: it exists as nine different isomers and among them~     myo-inositol and D-chiroinositol are the most represented and studied in physiology and~     physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans~     administration has been reported to exert beneficial effects at metabolic, hormonal and~     ovarian levels.~      The aim of this randomized study is to evaluate the metabolic and ovaric effects of a~     six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and~     hyperinsulemia.~   "
109236|NCT01626430|"~     Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF)~     on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at~     risk for metabolic syndrome.~      Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers~     and postprandial lipemia in individuals at risk for metabolic syndrome.~   "
109237|NCT01626417|"~     The objective of this clinical study is to examine the acute kinematics and kinetics of~     utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing~     sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings~     (internal to the device); to compare these metrics to baseline performance without the~     Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal~     force distribution) movement state in these patients.~   "
109238|NCT01626404|"~     Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients~     are underserved. The purpose of this prospective, observational study is to obtain~     multi-center data on the proportion of patients with CRT and/or ICD who are candidates for~     advanced heart failure treatment and obtain insights into patient and physician decisions~     regarding referral for advanced heart failure therapy.~   "
109239|NCT01626391|"~     The primary purpose of this study is to assess the safety and tolerability of TRx0237 when~     taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or~     rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's~     Disease.~   "
109240|NCT01626378|"~     The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the~     treatment of patients with behavioral variant frontotemporal dementia (bvFTD).~   "
109241|NCT01626365|"~     The purpose of this study is to investigate the effect of double-lumen tube thermosoftening~     before intubation to reduce postoperative hoarseness and sore throat.~   "
109242|NCT01626352|"~     This is a single-arm, Phase II study designed to enroll and treat up to 64 patients. All~     patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6~     cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion~     bendamustine Days 1 and 2 of Cycles 1 through 6 and ofatumumab Days 1 and 8 during Cycle 1~     only and on Day 1 of Cycles 2 through 6.~   "
109243|NCT01626339|"~     Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will~     be recruited in this prospective self-controlled trial. Fundus photography will carried out~     at baseline immediately before injection and at 3, 7 days and 30 days after the first~     injection. Using image analysis software, measurements summarized as the central retinal~     artery equivalent (CRAE) and central retinal vein equivalent (CRVE).~      Null Hypothesis: There is no significant difference between arteriolar/venular diameter~     before and after injection of intravitreal ranibizumab/bevacizumab in the treated and~     untreated eye~   "
109244|NCT01626326|"~     This is an initial pilot study to determine whether people will use a research version of an~     iPhone Stop Smoking app. The investigators primary measures will consist of rates of~     recruitment (that is, number of people installing the app), use of the app, and completion~     of follow-up surveys regarding self-reported smoking status. The investigators secondary~     measure will be obtained quit rates and number of cigarettes smoked before and after using~     the app.~      To enter the study, participants must download the app from iTunes at:~      https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8~   "
109245|NCT01626313|"~     The study will examine the effectiveness of an eight session, manualized individual family~     resiliency training (IFRT) for families with one OEF/OIF/OND veteran in promoting better~     family communication relating to return to post military life.~   "
109246|NCT01626300|"~     The purpose of this study is to determine if the daily use of a certain amount and type of~     milk component for 2 months provides a significant stimulation to the immune system and~     specifically increases the chances of being protected against pneumonia after the~     vaccination.~   "
109247|NCT01626287|"~     Perineal trauma is common during vaginal birth. The discomfort this causes can interfere~     with a woman's recovery and early motherhood.Mothers are offered a standard treatment after~     childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However,~     a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment~     that may be more comfortable and effective for women is warm water soaked black tea bags.~     Medicinal use of black tea bags has been based on their astringent (shrinking or~     constricting) properties and have been used for various medical applications.~      The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant~     mothers randomized to either intervention group (tea bags; n=20) or control group (ice~     packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing~     recruitment, testing the protocol, and evaluating a proposed primary outcome objective of~     analgesic use during hospitalization as an indicator of pain. The investigators expect this~     pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the~     efficacy of black tea bags to reduce perineal pain in this patient population.~   "
109269|NCT01626001|"~     The goal of this clinical research study is to learn about ways to possibly reduce scanning~     errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in~     patients with esophageal or lung cancer.~   "
109270|NCT01625988|"~     To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in~     migraineurs with or without aura during 3 months of treatment.~   "
109248|NCT01626274|"~     The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours~     non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a~     photoplethysmographic device for reflective mode measurements of the optical damping upper~     skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear~     sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate~     variability, breathing and arterial blood oxygenation are monitored in patients with sleep~     apnoea and compared to measurements of standard polysomnography of these patients during one~     night in the sleep laboratory.~   "
109249|NCT01626261|"~     The number of active electrical cardiac implants such as internal cardioverter~     defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly~     risen over the last two decades. This has been paralleled by an increase in the number of~     sources of electromagnetic fields in daily life and occupational circumstances.~      To date it remains unclear whether patients are at risk of device failure when being~     subjected to these fields. There are currently no general guidelines available to help~     clinicians informing their patients about safety levels and behavior around these~     electromagnetic fields.~      This study aims to identify the thresholds of safe use of these devices and potential~     failures under worst-case conditions in 50/60 Hz fields (i.e.~      power line frequency). Device implanted patients will be exposed to electric, magnetic and~     combined fields of different intensity at various device programming (e.g. nominal and~     maximum sensitivity). The results will show whether patients are safe in public or~     occupational environments, which medical relevant disturbances can occur and if a~     correlation exists between disturbances and device type or patients physique.~   "
109250|NCT01626248|"~     The purpose of the study is to research the association between receiving Tysabri®~     (natalizumab), interferon beta-1a, glatiramer acetate or not having any treatment for your~     MS and how it may or may not impact certain white blood cells and other immunological~     markers. This information may be useful in identifying risk factors in developing~     progressive multifocal leukoencephalopathy (PML). It does appear that the risk increases~     with the total number of natalizumab infusions. Patients who have not yet started a disease~     modifying therapy or who have been on one other than natalizumab are needed as controls to~     see how these biomarkers change.~      Patients at various stages of natalizumab treatment as well as natalizumab naïve are needed~     to allow for analysis of the change in potential markers over time.~   "
109251|NCT01626235|"~     Study aims to assess patient-recorded outcomes of pain control medications prescribed in the~     ER after visits for specific painful injuries/illnesses.~   "
109252|NCT01626222|"~     The present multi-center, open-label, single-arm study aims to evaluate the efficacy and~     safety, quality of life and health resources utilization in postmenopausal women with~     hormone receptor positive breast cancer progressing following prior therapy with~     non-steroidal aromatase inhibitors (NSAI) treated with the combination of Everolimus and~     Exemestane.~   "
109253|NCT01626209|"~     Dose escalation study with a dose expansion phase, to evaluate safety, tolerability,~     pharmacokinetics and preliminary efficacy of two dose levels of BKM120 when administered~     orally.~   "
109254|NCT01626196|"~     Several factors are important in achieving a successful colonoscopy, including patient~     acceptability of the bowel cleansing procedure and the overall quality of cleansing.~      This observational study has been designed to explore the main determinants of acceptability~     of the bowel cleansing procedure to the patient in an Italian real life setting. In~     addition, the study is to examine the determinants of quality of bowel cleansing and~     describe aspects of the technical performance of the colonoscopy (time to reach the caecum~     and adenoma detection rate).~   "
109255|NCT01626183|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer~      PURPOSE: This laboratory study is looking into RNA in samples from younger patients with~     T-cell (T) acute lymphoblastic leukemia (ALL).~   "
109256|NCT01626170|"~     This laboratory study is looking into mechanisms of radiation therapy resistance in samples~     from younger patients with rhabdomyosarcoma. Studying samples of tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors find better ways to treat~     cancer~   "
109257|NCT01626157|"~     Inflammation is present in the Cystic fibrosis (CF) airway from the time of infancy, and~     worsens with the onset of chronic infection. Therapies with proven benefit are associated~     with decreased airway inflammation. Thus, sensitive and reproducible biomarkers of airway~     inflammation have long been sought as a necessary component to improved clinical care and to~     facilitate therapeutic trials for CF. FEV1, the standard outcome measure in CF, is~     recognized as an insensitive outcome measure. the investigators have identified a panel of~     10 genes which sensitively predict resolution of pulmonary inflammation, in response to~     therapy of an acute pulmonary exacerbation. With the goal of yielding a technically simple~     but unique CF biomarker assay, the investigators have tested whether proteins signified by~     these genes show large changes in expression following treatment of acute pulmonary~     exacerbations. Protein quantifications are among the most common measurements performed in~     clinical laboratories around the world. Based on preliminary findings that changes in white~     blood cell proteins mirror changes seen in the genes, the investigators propose to identify~     top candidate proteins, from the investigators gene panel, which change in response to~     exacerbation therapy. Once identified, these proteins will be quantified directly with a new~     blood test which is inexpensive and simple to perform. The investigators propose to validate~     this blood test in a single site trial. If successful, this proposal will yield a biomarker~     assay that will be available to validate in a multi-site trial and provide unique insights~     into mechanisms that regulate white blood cell activation and recruitment in CF lung~     disease.~   "
109258|NCT01626144|"~     It is the investigators hypothesis that exemestane (EXE) metabolism is an important source~     of the inter-individual variation in EXE metabolic profiles and that polymorphisms in~     EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy~     and toxicity. The goals of this clinical study are to (1) establish EXE metabolism profile~     kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme~     genotype and urinary EXE metabolite profiles in women being treated with EXE. Together,~     these studies will allow us to fully characterize functionally-relevant polymorphisms in the~     EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.~   "
109259|NCT01626131|"~     The primary objective of this pilot intervention study is to examine the efficacy of~     exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other~     psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with~     combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups.~     Participants in the exercise training group (n = 20) will receive three 60-75 minute~     sessions per week of combination aerobic and resistance training for eight weeks. In the~     control stretching group, participants (n = 20) will receive training in whole-body~     flexibility three times per week for eight weeks. Secondary objectives include 1)~     determining feasibility of the intervention (as measured by the percentage of prescribed~     days of exercise completed by each participant, and percentage of time exercising completed~     at the prescribed intensity and duration); 2) determining the influence of exercise training~     on aerobic fitness and strength in the sample; and 3) determining whether~     psychiatric/somatic symptom improvements are associated with improvements in fitness and~     strength. Finally, exploratory objectives will include examining whether exercise training~     can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI~     data and inflammatory markers) are associated with treatment response.~   "
109260|NCT01626118|"~     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and~     effective for the treatment of postoperative bunionectomy pain.~   "
109261|NCT01626105|"~     This study is designed to accurately identify the pharmacogenetic determinants of risk of~     Factor VIII (FVIII) inhibitor development by focusing on only a select group of Hemophilia A~     (HA) patients who have: (i) received a recombinant FVIII therapeutic product containing the~     same primary amino acid sequence since their original diagnosis; (ii) verifiable FVIII~     infusion histories; and (iii) been tested regularly for FVIII inhibitor development.~   "
109262|NCT01626092|"~     This study is designed to test the ability to achieve donor hematopoietic engraftment while~     maintaining low rates of transplant-related mortality (TRM) in patients with high-risk~     lysosomal and peroxisomal disorders using a novel conditioning regimen for hematopoietic~     cell transplantation (HCT). After a reduced-intensity conditioning regimen using~     volumetric-modulated arc therapy (VMAT)-delivered low-dose total body irradiation (TBI) with~     highly conformal marrow boosting, patients will be transplanted using either a related or~     unrelated allograft. The cell source may be marrow, peripheral blood or cord blood based on~     donor availability.~   "
109263|NCT01626079|"~     The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy~     for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm~     the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe~     or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who~     are treated per standard of care and who have been determined by the site's local heart team~     as not appropriate for mitral valve surgery. This randomized controlled trial will provide~     the opportunity to strengthen or add labeling claims regarding safety and clinical benefits~     of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or~     severe functional mitral regurgitation.~      Approximately 610 subjects will be randomized at up to 100 investigational sites with~     approximately 305 subjects targeted to receive the study device.~      As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary~     exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise~     responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group)~     compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study~     subjects will contribute to the analyses of the COAPT primary and secondary endpoints)~   "
109264|NCT01626066|"~     Real-time detection of cancer cells during surgical removal of a tumor is important.~     Currently when tissue is removed at the time of surgery, the removed tissue goes to~     pathology when the margins (edges of the tissue) are examined to see if cancer cells are~     present. This may take a few to several days. Patients tissue with positive (cancer cells~     present) margins may require additional therapies including surgery. The purpose of this~     study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent~     contrast agent or dye, that will show in the tumor area during surgery and may help~     facilitate visualization of tumor for its removal.~   "
109265|NCT01626053|"~     It is hypothesized for this study that the coupling of the Millon Behavioral Medicine~     Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and~     ongoing support can produce improved outcomes with diabetics who have previously been~     unsuccessful with the traditional care. This study examined the relationship between~     patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted~     program involving psychological intervention. The study was conducted through the Kosciusko~     Health Department and funded by K21 Health Foundation.~   "
109266|NCT01626040|"~     The purpose of this study is to examine the effects of current standard of care Polyethylene~     Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of~     the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion~     of patients with clinically significant serum electrolyte abnormalities at the time of~     colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well~     the bowel is cleansed with this preparation, and 2) to determine the most effective way to~     communicate instructions about the bowel preparation with the child and family.~   "
109267|NCT01626027|"~     The aims of this prospective, observational study are to assess the current use of~     depression care in Coronary Heart Disease (CHD) patients, and to provide estimates for the~     resources needed to implement guideline-oriented depression health care acceptable to CHD~     patients with comorbid depression.~   "
109268|NCT01626014|"~     Ovarian cancer accounts for more deaths than any other gynecologic malignancy. The majority~     of patients are diagnosed with Stage III-IV disease. Nearly 80% of these patients will recur~     resulting in 5-year survival rates of 14-32%. Although enrollment is increasing in hospice,~     hospice programs have been challenged to reach eligible patients. Several factors limit the~     number of people who enroll in hospice and the length of their hospice stay. Prognostication~     challenges and the increasing availability of cancer therapies for people with cancer set~     the stage for a mismatch between certification of a 6 month prognosis and contemporary~     medical care. Additionally patients often are not aware of hospice and the services they can~     provide.~   "
109271|NCT01625975|"~     Understanding bone growth and achieving bone deformity corrections re-mains one of the~     oldest challenges in paediatric orthopaedics.~      The purpose of this study is to investigate the clinical and biomechanical effects of~     implants for growth modulation in pediatric patients undergoing correction of leg length or~     deformities of the knee.~      The primary aim of the study is to assess outcome after growth modulation using the Eight~     plate (Orthofix) at the time of implant removal with regard to any Adverse Events (AE)~     related to the growth plates or implants under investigation. The secondary aims are to~     assess if the planned correction was achieved and if the achieved correction was maintained~     after implant removal. Furthermore, secondary aims include investigation of the number and~     type of revision surgeries, the proportions of any other local AE as well as any influencing~     factors for growth modulation.~   "
109272|NCT01625962|"~     This is a prospective, longitudinal cohort study to evaluate the associations between~     indices of brain structure and function (measured at baseline, as soon as possible after~     injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be~     service members who have sustained mild traumatic brain injury (classified as either~     impact-induced mTBI or blast-induced mTBI; n = 100 completers) or an extracranial injury~     (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will~     complete an assessment battery at baseline and 6 months later that includes (1) structural~     magnetic resonance imaging(MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla~     magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity;~     (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain~     structure and function derived from these assessments are hypothesized to demonstrate a~     significant relationship with course of PTSD symptoms, which will be measured at baseline, 3~     months, and 6 months.~   "
109273|NCT01625949|"~     Background: When an acute myocardial infarction occurs, the artery supplying the infarct~     zone should be opened within twenty four hours of onset of infarction. This has clearly been~     shown to be beneficial.~      If the patient presents later than 24 hours of onset, at that stage a large part of the~     damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is~     controversial). Some trials suggest that opening the artery even at this stage positively~     modifies the remodeling process while other trials suggest that such a benefit is not seen.~      Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining~     it with intracoronary stem cell therapy may provide incremental benefit.It is possible that~     the lack of benefit seen with late revascularization (>24 hrs) after MI may be offset by~     giving intracoronary stem cells after opening the artery.~   "
109274|NCT01625936|"~     This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in~     combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of~     this study is to determine the initial safety and effectiveness of this agent in combination~     with Bevacizumab. The investigators are also trying to determine the best dose level of~     CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this~     study at the University of Pennsylvania.~   "
109275|NCT01625923|"~     Gastroparesis is a disorder characterized by impaired gastric emptying in the absence of~     obstruction in the proximal GI tract. It is a common condition affecting up to 5 million~     persons in the United States alone. Despite this, metoclopramide is currently the only FDA~     approved medication for the treatment of gastroparesis. However, the evidence supporting~     metoclopramide in gastroparesis is fairly weak and was recently issued a black box warning~     because of potential irreversible side effects. There is clearly an urgent need for newer~     therapeutic options with better efficacy and tolerability. Olanzapine is a second generation~     anti-psychotic that is currently FDA approved for the treatment of schizophrenia and bipolar~     disorder. Because of actions at several receptors throughout the body, including dopamine~     and serotonin receptors, Olanzapine may provide anti-nausea and pro-motility effects in the~     stomach. Long-term use of olanzapine may also increase plasma levels of ghrelin. Ghrelin is~     a hormone produced by the gut that stimulates appetite and has also been shown to have~     beneficial effects on gastroparesis. The investigators hypothesize that olanzapine will be~     effective and safe in controlling symptoms as well as stimulate appetite and weight gain in~     gastroparesis. The investigators also hypothesize that olanzapine will stimulate gastric~     motility. Finally, the investigators hypothesize that olanzapine will modulate the secretion~     of ghrelin in gastroparesis. This pilot study may provide further information on the~     efficacy and safety of olanzapine in gastroparesis which could be utilized in a larger~     randomized, prospective study in the future.~   "
109276|NCT01625910|"~     Childhood obesity is a major public health problem in the U.S. Currently approximately one~     in three children is considered overweight or obese. Most overweight children grow to become~     overweight adults. It is unclear how effective pediatricians and other primary care~     physicians can be in assisting overweight children to normalize their body weight. Expert~     guidelines have been established, but are currently untested.~      This study will randomize overweight and obese children between the ages of 4 and 8 years~     old to either the recommended treatment guidelines or a control (non-intervention) group.~      The purpose of this study is to evaluate the ability (a) to recruit overweight children~     between the ages of 4 and 8 years old (b) to remeasure the children three months after~     enrollment and (c) to reduce childhood obesity via implementation of the recommended~     treatment guidelines.~   "
109277|NCT01625897|"~     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy~     of MP-214 in patients with chronic phase or elderly schizophrenia.~   "
109278|NCT01625884|"~     In Turkey statin compliance is lower than EU countries. (EURIKA). We will assess the~     underlying causes of statin incompliance. The investigators will build patient and physician~     education programs to improve compliance in TURKEY. Our aim is to assess patients' and~     physicians' attitudes to statins by mean of HABIT Patient and Physician survey respectively.~   "
109279|NCT01625871|"~     The cure rate of artemether/lumefantrine in the treatment of vivax malaria.~   "
109289|NCT01625741|"~     This study explores the potential to improve the quality of response obtained after~     induction treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense~     consolidation schema using high-dose rituximab. Patients in suboptimal response (Minimal~     Residual Disease persistence) after induction will be selected, as well as those who have a~     Minimal Residual Disease (MRD) relapse after having achieved MRD negativity.~   "
109280|NCT01625858|"~     The supraglottic airway device LMA Supreme has recently been introduced for pediatric~     patients. The investigators will prospectively evaluate success rate and airway leak~     pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that~     the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak~     pressures will be compared to results from other pediatric supraglottic airway devices~     previously studied by the investigators group. Secondary Hypothesis: The primary success~     rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance~     of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational~     cohort study.~      In a second step, we will include more pediatric supraglottic airway devices. Each new arm~     will be handled exactly the same, assuming the same hypothesis being justified.~   "
109281|NCT01625845|"~     The objective of this clinical trial is to evaluate whether an anti-inflammatory medication,~     pentoxifylline, reduces depressive symptoms and improves artery function. Participants in~     this trial will be older primary care patients (60 years and up) who are depressed but do~     not have a history of cardiovascular disease. Half of these patients will receive~     pentoxifylline, and half will receive placebo. In addition, participants in both arms will~     receive an evidence-based psychological treatment called Beating the Blues®, which is a~     computerized, cognitive behavioral treatment program for depression. The investigators will~     use questionnaires to assess change in depressive symptoms and an ultrasound test to measure~     change in artery function from pre- to post-treatment. It is hypothesized that patients who~     receive pentoxifylline will show greater improvements in both depression and artery function~     than patients who receive placebo.~   "
109282|NCT01625832|"~     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in~     industrialized countries despite advances in medical, interventional, and surgical~     revascularization therapies. In both, acute myocardial infarction (AMI) and chronic stable~     disease, standard therapeutic approaches may fail to restore tissue perfusion. Indeed, a~     substantial number of chronic CAD patients may not be amenable to standard revascularization~     therapies or percutaneous coronary intervention (PCI) may fail to restore coronary artery~     patency following an acute vessel occlusion (no-reflow phenomenon, microvascular~     obstruction). As a consequence, the long pursued strategy of augmenting myocardial perfusion~     by diverting blood from the coronary venous system to an ischemic region (venous~     retroperfusion) has again gained attention during recent years. Occlusion of the coronary~     sinus (CSO) was introduced to provide retroperfusion by transient augmentation of coronary~     venous pressure. Different devices using CSO have been invented and evaluated in animal~     models and small clinical trials, e.g. intermittent CSO (ICSO) and pressure-controlled~     intermittent CSO (PICSO) which seem to be effective for myocardial salvage. However, they~     are not yet employed in clinical routine, and importantly, the exact underlying mechanisms~     by which retroperfusion due to CSO may reduce myocardial ischemia are not yet understood.~      As natural bypasses, coronary collaterals are anastomoses without an intervening capillary~     bed between portions of the same coronary artery or between different coronary arteries that~     represent an alternative source of blood supply to a myocardial area jeopardized by~     ischemia. Collaterals of the heart can be assessed quantitatively by coronary pressure~     measurements, which have become the gold standard (collateral flow index,~     CFI=[Poccl-CVP]/[Pao-CVP]). Theoretically, augmentation of coronary sinus pressure by CSO~     with an increase of venous backflow reaches the upstream collateral circulation, which in~     turn could lead to improved collateral flow from non-ischemic area(s) to an occluded,~     ischemic myocardial region by upstream flow diversion. On the other hand, when considering~     the formula to calculate pressure-derived CFI, it seems that augmentation of coronary back~     pressure would rather impair collateral flow (since central venous pressure is coronary~     sinus pressure). However, the regional effect of a global increase in coronary sinus~     pressure is unlikely to be as uniform as the above formula implies, i.e., the response is~     more pronounced in some than in other vascular territories. In experimental studies using~     dogs (with abundant collaterals), elevation of coronary sinus pressure caused an~     augmentation of regional myocardial blood flow in the collateralized area. In contrast, when~     ICSO was performed in pigs (which possess no preformed collaterals), it increased the~     pressure distal of an occluded LAD but did not improve blood flow or left ventricular~     function.~      In conclusion, experimental studies and pathophysiologic considerations suggest a necessary~     role of the collateral circulation for the beneficial effects of coronary sinus occlusion~     (CSO) observed in animals and humans; however, no clinical data are available so far on the~     effect of CSO on myocardial ischemia in the presence of varying collateral flow.~      Study hypotheses~        1. CSO decreases intra-coronary ECG ST-segment elevation during a 2-minute coronary~          occlusion.~        2. The decrease in occlusive intra-coronary ECG ST elevation during CSO is directly~          proportional to CFI.~        3. Coronary sinus oxygen saturation during coronary occlusion with CSO is directly~          proportional to CFI.~   "
109283|NCT01625819|"~     The objective of this research is to compare Tai Chi versus Resistance Exercise, Health~     Education and usual care for changes in cardiac functional capacity measured for ability of~     the heart to pump by measuring ejection fraction (EF), end systolic and diastolic volumes in~     heart failure (HF) patients. Also measured will be changes in physical function measured by~     walking speed and distance in the 6-min walk task, work performed during a bicycle task, and~     changes in daily physical activity. The investigators will compare groups for altered~     well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and~     quality of life. In addition the investigators will compare groups for altered vascular and~     pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to~     the bicycle task. Also, the investigators will assess cardiac related hospitalization and~     death over a 12 month period by examining medical records.~   "
109284|NCT01625806|"~     This single-center, open-label, parallel group study will evaluate the effects of multiple~     doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male~     volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects~     assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours)~     from Day 1 to Day 17.~   "
109285|NCT01625793|"~     The current study has been designed to identify behavioral and physiological mechanisms~     through which positive social connectivity (PCS) and negative social processes (NSP)~     interact with psychosocial stress to promote resilience in the context of illness. The~     investigators model inflammation (a central element of all disease states) through the use~     of treatment with interferon (IFN)-alpha, which provides a standardized regimen of chronic~     cytokine exposure known to produce profound behavioral disturbances, including depression,~     fatigue and sickness, in a high percentage of individuals. To objectively assess social~     processes, the current project will employ the Electronically Activated Recorder (EAR),~     which periodically and unobtrusively records snippets of ambient sounds in people's~     momentary environments. To objectively assess behavioral and physiological responses to~     psychosocial stress the current project will employ the Trier Social Stress Test (TSST), a~     standardized laboratory stressor known to reliably activate behavioral, neuroendocrine and~     inflammatory responses. These novel methodologies and model systems will be employed to test~     the hypotheses that (a) pre-existing affiliative and prosocial behavior will promote~     resilience in the context of chronic inflammation and that (b) —conversely—chronic~     inflammation will reduce affiliative and prosocial behavior via effects on stress~     reactivity, neuroendocrine function and sleep. Finally, it will explore (c) the potential~     mediating role of stress physiology. To test these hypotheses, 110 subjects with chronic~     hepatitis C virus infection will be randomized to receive treatment with pegylated IFN-alpha~     plus ribavirin or to postpone treatment for 6 weeks: 55 subjects at University of Arizona~     and 55 subjects at Emory University. Prior to randomization and 6 weeks later all subjects~     will be evaluated with the EAR and sleep actigraphy in their home environments and will~     undergo TSST and 14 hour diurnal neuroendocrine and immune measurement.~   "
109286|NCT01625780|"~     Ilio-inguinal nerve blocks have a long history of efficacy in treatment of post-operative~     pain following inguinal surgery. Several anatomic studies have shown that the nerves~     supplying the inguinal area have a certain degree of variability with respect to their~     location between the internal and external oblique layers of the anterior abdominal wall.~     Furthermore, the standard single-shot approach to ilio-inguinal nerve blocks has a~     significant incidence of unintended femoral nerve block, which can impair patients' ability~     to walk after surgery. The investigators are proposing a new approach to the ilio-inguinal~     nerve block, which divides the total dose of local anesthetic into 3 equal parts, injecting~     each 1/3 into different layers of the anterior abdominal wall and sub-cutaneously. The~     investigators intend to show that this new technique, the Tsui approach, provides equal~     analgesia to the standard single-shot ultrasound-guided ilio-inguinal nerve block, while~     being faster to perform and having a lower incidence of unintended femoral nerve blockade.~     Patients under age 10 who are scheduled for elective inguinal surgery (hydrocele repair,~     orchidopexy, and inguinal hernia repair), who have already consented to an ilio-inguinal~     nerve block that is commonly placed for this type of procedure, will be approached to~     participate in this study. No increased risk is anticipated for these patients, as both~     ultrasound-guided and blind techniques are equally well-accepted in the literature for this~     type of block, and in addition there are few vascular or neural structures in this~     anatomical area (just medial and inferior to the anterior superior iliac spine) that may be~     damaged. Follow-up will be limited to an assessment of pain scores in the PACU~     post-operatively and any unintended femoral nerve blockade in post-PACU. This will not delay~     their hospital discharge as these are same-day surgery patients.~   "
109287|NCT01625767|"~     This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses~     in smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive~     bias towards tobacco-related stimuli.~   "
109288|NCT01625754|"~     Many studies have shown that those with coronary artery disease (CAD) have a more rapid~     decline in memory than expected and that they are at an increased risk of developing~     dementia. It is not understood how memory decline is linked to CAD; however, it has recently~     been discovered that certain byproducts of fat breakdown involved in the development of CAD,~     called ceramides, can harm brain cells. In the present study the investigators will recruit~     129 CAD patients from a cardiac rehabilitation facility and measure memory performance and~     blood ceramide concentrations at baseline, 3 months and 6 months. The investigators will~     also measure important blood messengers of inflammation and assess whether they are~     associated with ceramide production. In addition, relationships between ceramides and other~     aspects of brain function, such as thinking speed and the ability to plan and sort~     information will be explored.~   "
109548|NCT01622335|"~     The study is prospective and double blind. In the clinic, patients undergoing hysterectomy~     that meet the criteria for inclusion into the study and agreed to participate in the study~     will be randomized into two groups.~   "
109290|NCT01625728|"~     The purpose of the study A comparison of vocal demands with vocal performance among~     classroom teachers is to gather information about the voice production of teachers using~     three separate strategies: (a) measures of voice assessed with the Computerized Speech Lab~     (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab.~   "
109291|NCT01625715|"~     The primary objective of this study is to evaluate, compared to non-treatment, the impact of~     a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day)~     of ketotifen on the adverse event profile emerging from a rapid peanut desensitization~     protocol, in children with established peanut allergy.~   "
109292|NCT01625702|"~     To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric~     cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.~   "
109293|NCT01625689|"~     In this Phase II randomized controlled clinical trial, generally healthy male and female~     children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh.~     The study is expected to continue for at least 6 months following vaccination. The~     experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live~     Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to~     WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is~     administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable~     sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited~     in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in~     appearance to the active vaccine.~      The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24~     through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among~     children receiving study vaccine as compared to children receiving placebo.~   "
109294|NCT01625676|"~     The purpose of this study is to assess the feasibility of modified Constraint-Induced~     Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified~     CIAT versus standard treatment with the same intensity of intervention.~   "
109295|NCT01625663|"~     Barth syndrome (BTHS) is an X-linked disorder caused by abnormal cardiolipin metabolism and~     is characterized by skeletal and cardiomyopathy and high mortality rates. Through clinical~     metabolism and imaging studies and pluripotent stem cell induction and molecular techniques~     on skin biopsy samples, this project will produce novel translational information regarding~     the pathogenesis of BTHS, reveal potential targets for interventions and provide unique data~     regarding nutrient metabolism and abnormal cardiolipin and mitochondrial function. This~     project has the potential to provide information that could significantly improve morbidity~     and mortality in children and young adults with BTHS and may have relevance to other~     non-BTHS related conditions such as aging and adult heart failure.~   "
109296|NCT01625650|"~     The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North~     America, Inc. is a Sub-study of the CORRONA Data Collection Program.~      The CERTAIN Sub-study is designed to systematically collect and document use patterns,~     effectiveness, comparative effectiveness and safety of biologic agents used in the~     management of Rheumatoid Arthritis (RA).~   "
109297|NCT01625637|"~     This is a two part study. In Study 2, smokers who want to quit smoking will participate in a~     4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with~     weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will~     exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach~     Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who~     are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach~     tendencies in the AAT test trials and the Implicit Association Task, when compared to~     adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent~     smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have~     better abstinence rates compared to those who receive placebo AAT training with CBT.~   "
109298|NCT01625624|"~     The purpose of this study is to determine the effect of food products varying in~     composition, on energy in healthy adult subjects.~   "
109299|NCT01625611|"~     The primary purpose of the study is to increase our knowledge of receptor function in the~     brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has~     been approved for the treatment of alcohol dependence. Receptors are special molecules in~     the brain to which other molecules (neurotransmitters) attach during the normal every-day~     workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence~     suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking~     behavior. This study will try to determine if naltrexone's ability to attach to these~     receptors is related to its effectiveness. We will use PET (positron emission tomography)~     for this study. PET is a type of imaging device found in nuclear medicine. It is used for~     tracking the presence of injected radioactive materials in the body.~   "
109300|NCT01625598|"~     The hypothesis is that computer detection of the severity of diabetic retinopathy including~     the presence of clinically significant macular edema is not inferior to the detection using~     a dilated eye examination by a Board-certified ophthalmologist.~   "
109301|NCT01625585|"~     The goal of the present study is to investigate the clinical outcomes of patients with~     gastrointestinal bleeding originating from the small intestine following diagnostic~     investigation with single balloon enteroscopy. We hypothesize that single balloon~     enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients~     with gastrointestinal bleeding originating in the small intestine.~   "
109302|NCT01625572|"~     The purpose of this study is to compare the quality of a transversus abdominis plane~     blockade with an intravenous pain therapy with opioids. Due to the relatively low side~     effect profile and comparably few contraindications, this method offers a good option, to be~     a standard procedure or better alternative in the treatment of pain in surgery of the~     prostate.~   "
109341|NCT01625065|"~     In this study medication compliance regarding current drug use is investigated using~     toxicological analyzes in two patient groups: patients from a pain management department and~     pre-surgical control patients. The aim is to explore the incidence of concealed and feigned~     substances and to determine the respective substance classes. Expecting that noncompliance~     is higher in the pain patient group, the investigators want to identify clinical risk~     factors for noncompliant drug report.~   "
109303|NCT01625559|"~     The purpose of this study is:~        -  To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD~          Group~        -  When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures.~        -  In future studies intended to assess the number of transplanted hRPE cells.~        -  In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of~          the potential.~        -  Homologous retinal pigment epithelial cells derived from embryonic stem cells, future~          studies of drugs that are used in representing the potential validity to evaluate the~          optimal dose.~   "
109304|NCT01625546|"~     Major depressive disorder (MDD) is predicted to be the second leading cause of disability~     worldwide by the year 2020. The economic burden of depression in the United States is~     significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high~     rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD~     patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients~     will fail to adequately respond to all currently available interventions. Moreover, current~     treatments come at the cost of significant central nervous system (CNS) side effects,~     further highlighting the need for more effective treatments with fewer side effects. This~     study will compare temperature ranges from the investigators preliminary studies involving~     thermoafferent pathways resulting in antidepressant actions with lower temperature ranges~     not expected to activate these pathways as a control condition, with the goal to evaluate~     whether previous observations were related to the temperature range in question or can be~     achieved with other levels.~   "
109305|NCT01625533|"~     The purpose of this study is to assess the clinical safety and efficacy of dual-axis~     rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by~     directly comparing it to standard coronary angiography (SA).~   "
109306|NCT01625520|"~     A mono centre study to evaluate the efficacy of SOM230 in patients with progressive~     metastatic or postoperative persistent medullary thyroid cancer.~   "
109307|NCT01625507|"~     The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA~     intervention, will have improved compliance with the nutritional therapy recommendations of~     the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of~     the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a)~     to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention~     program that promotes the individual factors required for effective self-management~     practices AND that explicitly incorporate strategies to improve food availability,~     accessibility and acceptability and (b) to use these interventions as a means to examine the~     relationships between food availability, accessibility, acceptability, adherence to~     Nutrition Therapy Guidelines, and metabolic indicators of diabetes control in people with~     type 2 diabetes.~   "
109308|NCT01625494|"~     Primary Objective:~      - To assess the proportion of patients with controlled Office Blood Pressure Measurements~     (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg,~     at the end of the study~      Secondary Objectives:~        -  To examine over time the antihypertensive effect of the 4 doses of the fixed~          combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and~          DBP (diastolic blood pressure)~        -  To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and~          diastolic BP<90 mmHg) of the different dose groups over time~        -  To determine the incidence and severity of adverse events.~   "
109309|NCT01625481|"~     The purpose of this study is to further assess the safety and performance of Seal-V as an~     adjunct to standard surgical procedure for achieving hemostasis in patients undergoing~     peripheral vascular reconstruction surgeries using synthetic grafts.~   "
109310|NCT01625468|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S. over the past two decades has left smoker's~     homes as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has~     considerable potential to reduce smoke exposure, but suitable channels to reach low-income~     families are limited. The proposed research will develop, evaluate and disseminate a brief~     smoke-free homes intervention through the established national infrastructure of 2-1-1 call~     centers. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for~     emergencies or 4-1-1 for directory assistance, that links callers to community-based health~     and social services.~      The proposed research has four specific aims: 1) Conduct formative research on intervention~     messages and materials for promoting smoke-free homes in low-income populations, applicable~     to both smokers and nonsmokers as household change agents; 2) Conduct a randomized~     controlled trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief~     intervention to create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies~     in Houston and North Carolina 2-1-1 systems to systematically test the intervention in~     varied populations and tobacco control climates, and 4) Disseminate the research-tested~     smoke-free homes intervention through a variety of mechanisms including a national grants~     program to 2-1-1 systems and through the Tobacco Technical Assistance Consortium's linkages~     to the state and local tobacco control infrastructure in the U.S.~   "
109311|NCT01625455|"~     The purpose of this randomized, double-blinded, placebo-controlled study is to test the~     hypothesis that administration of aprepitant will decrease the severity of pruritus in~     patients with Sèzary Syndrome.~   "
109312|NCT01625442|"~     The metabolic syndrome is associated with increased risk of cardiovascular disease and~     diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United~     States is 34% for men and 35% for women. Emerging alternative medicine worldwide led~     investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris~     (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL~     cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit~     measured before and after 45 days of treatment.~   "
109313|NCT01625429|"~     This is a single-center, prospective, single arm phase II study to evaluate the efficacy and~     safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as~     neoadjuvant therapy in operable locally advanced breast cancer patients. The primary~     objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample~     size is 30.~   "
109342|NCT01625052|"~     The investigators group has performed a number of studies on novel airway devices, including~     an observational study on the performance of a new supraglottic airway named Baska mask. In~     this new study the investigators wish to determine which criteria best predict the correct~     size of the Baska mask to be used in male patients~   "
109343|NCT01625039|"~     The introduction of a wellness programme for workers employed in a clothing factory will~     improve quality of life, pain, attendance at work and levels of physical activity.~   "
109314|NCT01625416|"~     After traumatic injuries some people have difficulty returning to the routine of their~     everyday activities and may experience physical and emotional pain. The purpose of this~     study is to identify new ways of providing support for physically injured trauma survivors.~     All study procedures are designed to work around patient needs and be as flexible as~     possible in order to best fit into patients' post-injury recovery.~      Patients who are eligible for the study are randomly assigned to receive care as usual, or~     the new method of treatment, with the study Trauma Support Specialist (TSS). This TSS will~     be in contact with the patient for the next three months; they may visit the patient at the~     hospital or at outpatient medical appointments. The TSS will also be available to talk with~     the patient over the telephone. Overall, the TSS will be working with the patient to help~     with difficulties returning to his or her routine and overcoming physical and emotional pain~     experienced after the injury. We believe that patients who receive the new method of~     treatment, will be more able to return to daily routines and/or cope with the emotional~     stress that can occur after an injury. Intervention technology innovations including mHealth~     applications and web-based links will be included in the investigation.~   "
109315|NCT01625403|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type~     natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated~     heart failure (ADHF) and acute renal injury (AKI).~   "
109316|NCT01625390|"~     Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one~     of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient~     levels. In a person with haemophilia, the clotting process is much slower and the person~     experiences bleeding episodes that can result in serious problems and potential disability.~      The current haemophilia standard of care is to maintain FVIII activity level above 1%.~     Sometimes, patients can develop antibodies (so called inhibitors) against FVIII and it is~     no longer effective at controlling bleeds. Bleeds in these patients are currently treated~     using other proteins involved in the clotting process.~      The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds~     in inhibitor patients. This study consists of two parts, A and B. The purpose of part A is~     to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to~     efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The~     purpose of part B is to confirm efficacy and safety of the dose found in part A in all~     participating patients (confirmatory part). Part B is expected to last 12-32 months.~      Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A~     or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last~     6 months, will participate in this study.~      Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response~     is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be~     required to keep an electronic diary.~   "
109317|NCT01625377|"~     The aims of the study was to evaluate the safety and efficacy of early introduction one~     month post-transplantation of everolimus associated to EC-MPS with tacrolimus~     discontinuation in de novo liver transplant recipients and to evaluate if it leads to a~     better renal function 6 month post-transplantation compared to standard treatment~     associating tacrolimus and EC-MPS.~      The renal function was estimated by glomerular filtration rate.~   "
109318|NCT01625364|"~     The purpose was to evaluate effectiveness and impact of an academic and counseling asthma~     health education program (SHARP) for fourth- and fifth-grade students diagnosed with asthma.~     Students attending schools randomized to the low-dose control condition received Open~     Airways for Schools (OAS). The first aim was to evaluate the effectiveness of SHARP,~     compared to the low-dose group, for students on cognitive, psychosocial, and behavioral~     aspects of asthma management at 1, 12, and 24 months post-intervention. We hypothesized that~     compared to students enrolled in elementary schools who received the low-dose program,~     students in elementary schools that received SHARP would increase asthma knowledge~     (cognition) and logical reasoning abilities for managing acute episodes (cognition),~     acceptance of asthma as a chronic condition (psychosocial), and use of effective asthma~     health behaviors (behavior). The second aim was to evaluate the long-term impact of SHARP,~     compared to the low-dose group, for students on condition characteristics, use of healthcare~     services, and quality of life at 12 and 24 months post intervention. We hypothesized that~     compared to students enrolled in elementary schools who received the low-dose program;~     students in elementary schools who received SHARP would decrease asthma severity, use of~     healthcare services, and school absenteeism due to asthma, and increase participation in~     life activities (quality of life).~   "
109319|NCT01625351|"~     This is a phase I study designed to determine the feasibility of transplantation using a~     novel transplant approach that employs a two-stage haploidentical cell infusion following~     myeloablative conditioning. This strategy, which includes selective depletion of naïve T~     cells, may speed immune reconstitution thereby potentially reducing the limitations of~     traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its~     potential therapeutic application. Additionally, the investigators intend to explore overall~     survival, event-free survival, hematopoietic cell recovery and engraftment as well as~     infection rates and complications in these patients.~   "
109320|NCT01625338|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)~     in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults~     with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study~     and have not achieved sustained virologic response (SVR).~   "
109344|NCT01625026|"~     By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but~     presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown~     in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high~     affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and~     glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively,~     that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone~     (GS) surgery where in addition to blood samples also biopsies are taken from the liver and~     in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder~     bile.~   "
109935|NCT01617291|"~     The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the~     pre-hospital setting of a four county emergency medical system (EMS) that serves both urban~     and rural communities improves meaningful survival from medical cardiac arrest.~   "
109321|NCT01625325|"~     While obese and extremely obese youth are at increased risk of health complications,~     especially the extremely obese group rarely seek medical care. One of the underlying reasons~     might be the lack of adequate treatment options. This study is a subproject of the Medical~     and psychosocial implications of adolescent extreme obesity - acceptance and effects of~     structured care study, short: Youth with Extreme obesity Study (YES), which aims at~     improving the medical care and social support structures for youth with obesity and extreme~     obesity in Germany. In this subproject, information on the causes and consequences of~     extreme obesity will be gathered via questionnaires and medical examinations.~      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years~     (initially up to 21 years) are eligible to participate. Participants will be asked to~     complete a series of questionnaires on their general health, psychosocial situation and~     wellbeing in 2-3 sessions. They will be offered a thorough medical examination comprising a~     general check-up, a fasting blood draw and oral glucose tolerance test, a focused~     orthopaedic examination, a sleep apnea screening, and an ultrasound of the liver. The aim of~     the study is to elicit the acceptance of diagnostic and therapeutic procedures, and to~     assess the frequency of co-morbidities in obese and extremely obese youth. This knowledge~     will optimize medical treatment and support options. Interested participants will be invited~     to participate in further steps of YES, which entail medical care and psycho-social support.~   "
109322|NCT01625312|"~     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal~     revascularization strategy in multiple vessel coronary artery disease patients remains a~     subject of debate between interventional cardiologists and surgeons. Knowledge about the~     real-life revascularization pattern and outcomes in China is limited. By consecutively~     recruiting three vessel coronary heart disease patients in 25 geographically representative~     highest-rank hospitals, this study will examine revascularization strategy, and various~     real-life factors, that may affect patients lone-term recovery. Practical guidelines,~     appropriateness criteria and quality evaluative system for revascularization strategy will~     be established based on the findings, to improve patients outcomes in future finally.~   "
109323|NCT01625299|"~     We hypothesize that in children with autism dietary antigens can change the intestine,~     making it leaky and then affecting the brain changing their behavior.~   "
109324|NCT01625286|"~     The purpose of this study is to investigate the safety and efficacy of different doses and~     schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with~     advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of~     AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in~     treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer,~     including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide~     (PIK3CA) tumor mutation.~   "
109325|NCT01625273|"~     The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an~     infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6~     months.~   "
109326|NCT01625260|"~     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801~     combined with gemcitabine for patients who have BCG failure (defined as refractory,~     relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically~     fit to undergo a radical cystectomy recommended by the participating urologist as the~     standard next therapy per urologic guidelines. The purpose of this study is to confirm the~     safety and tolerability of a well-tolerated dose level of ALT-801, to determine the~     Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with~     gemcitabine in treated patients. The anti-tumor responses will also be assessed.~   "
109327|NCT01625247|"~     Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The~     role of routine drainage after LC to decrease postoperative morbidity is still an issue of~     considerable debate. The goal of this study was to assess to role of drains in LC, performed~     for acute inflamed gallbladder.~   "
109328|NCT01625234|"~     This is the first human study to use X-396 (ensartinib), a drug being developed for~     treatment of advanced cancers. The initial purpose of the study is to determine the largest~     amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the~     recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary~     anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also~     provide early information on how the body handles the drug (pharmacokinetics) and on the~     efficacy of X-396.~   "
109329|NCT01625221|"~     The purpose of this feasibility study is to obtain preliminary safety and effectiveness~     information and develop procedural optimization for the Magnetic Anal Sphincter device~     (FENIX System) in reinforcement of anal sphincter function to treat severe fecal~     incontinence (FI).~   "
109330|NCT01625208|"~     This study will examine how successfully nerves are blocked or frozen for hand surgery.~     Traditionally, the nerves are frozen at the base of the neck, just above the clavicle or~     collarbone (the supraclavicular block). This is mostly successful by itself, and provides~     anesthesia of the entire arm. Occasionally, an additional nerve block is required further~     down the arm, as the supraclavicular block may have missed a segment, or it is taking too~     long to come on. In this study the investigators will compare the traditional technique,~     with a similar but lower volume supraclavicular block plus an immediate low volume block of~     one nerve further down the arm (the ulnar or median nerve block, depending on which digits~     are being operated on). The investigators will compare success rates, speed of onset,~     procedural comfort and length of time of weakness and numbness, plus any adverse events.~   "
109345|NCT01625013|"~     This study aims to study use of viscosupplementation as a treatment of pain for young~     individuals who are active. Typically viscosupplementation is considered an intervention for~     knee osteoarthritis often for older patients who are less active. Many young active patients~     can also develop knee osteoarthritis after trauma or surgery or for congenital reasons.~     Treatment of these patients commonly are steroid injections which have more biologically~     detrimental effects for cartilage compared to viscosupplementation Synvisc One injections~     which are a single injection will be used to determine effectiveness of reducing pain and~     maintaining an active healthy lifestyle for younger patients aged 30-50 years old.~   "
109346|NCT01625000|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214~     relative to placebo in patients with acute exacerbation of schizophrenia.~   "
109331|NCT01625195|"~     Nutrition is key to healthy aging for a number of diseases but the investigators have~     reported imbalances in the distribution of long chain omega-3 fatty acids (LC-omega-3) in~     the elderly and in the carriers of apolipoprotein E epsilon 4 (APOE4) isoform. Carrying~     APOE4 isoform is currently recognized as being the most important genetic risk factor of~     cognitive decline. The investigators believe that dysregulation of LC-omega-3 metabolism is~     intimately link with higher risk of cognitive decline. The current project will investigate~     whether there is a causal relationship between LC-omega-3-enriched diet and cognition using,~     on the one hand, a randomized double-blind placebo-controlled design and on the other hand,~     transgenic mice carrying human APOE4. In both study, the investigators will focus~     specifically on the distribution (level) of LC-omega-3 into lipoproteins with age and/or~     APOE4 isoform to evaluate whether dysfunctional transport of LC-omega-3 is associated with~     lower cognitive scores on visuospatial capacity, verbal fluency or working memory. In APOE4~     mice, the investigators will evaluate LC-omega-3 brain uptake together with the level of~     LC-omega-3 in the brain membranes and the level of APOE protein within the brain. The~     present investigation will provide key basis for understanding how to develop nutritional~     strategies for healthy aging and the preservation of cognitive function.~   "
109332|NCT01625182|"~     The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of~     chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.~   "
109333|NCT01625169|"~     HIV positive pregnant women who receive potent combination antiretroviral therapy over at~     least the last trimester of pregnancy, and who have proper obstetric interventions and are~     able to avoid breast feeding, decrease the risk of having an infected infant to about 1%.~     Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk~     transmission, and a 2-fold increased risk of transmission associated with every 10-fold~     increase in breast milk viral load has been reported. In addition, cell associated virus~     (HIV DNA) was associated with a significant increase in risk of transmission independent of~     the level of cell-free viral RNA.~      However, multiple studies of HIV positive women giving birth have shown that exclusive~     breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding~     (defined as breast milk along with complementary food, other milk, and/or infant formula).~     The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in~     blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal~     is to determine how much etravirine penetrates into breast milk, and whether it leads to~     undetectable HIV viral load in the breast milk and therefore has the potential to decrease~     the risk of transmission of HIV through breast milk. The long term goal is to see if breast~     milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT)~     of HIV in infants receiving only breast feeding in resource poor areas.~   "
109334|NCT01625156|"~     This phase I trial studies the side effects and best dose of tivantinib when given in~     combination with temsirolimus in treating patients with solid tumors that have spread to~     other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
109335|NCT01625143|"~     This laboratory study is looking into genes in samples from younger patients with relapsed~     acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~   "
109336|NCT01625130|"~     Purpose: To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies~     responses to O3. Participants: Recruitment of up to 70 healthy volunteers, ages 18-50, for~     completion of 36 volunteers. Procedures: This is a randomized, placebo controlled 2x2~     crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers~     which will examine airway inflammation before and 4 hours after a 2 hour 0.4 ppm O3~     exposure. Participants will be randomized to received either the NRF2 modifier, SFN oral~     supplement (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a~     0.4 ppm O3 exposure for 2 hours. At least 2 weeks later subjects will return for a 2nd~     supplementation treatment (using the alternative supplement to that provided initially)~     followed by an ozone exposure identical to the initial one.~   "
109337|NCT01625117|"~     The purpose of this study is examine, whether a treatment approach, which is specifically~     tailored for perpetrators who have participated in violence (a variant of Narrative Exposure~     Therapy) is effective in the reduction of instrumental aggression and symptoms of~     posttraumatic stress disorder.~   "
109338|NCT01625104|"~     The primary objective of this study is to assess whether an aggressive quality improvement~     intervention strategy will decrease time from hospital presentation to first balloon~     inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with~     primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were~     randomized to either aggressive intervention or control. The intervention consisted of Grand~     Rounds at each hospital, sharing of best practices, and coordinating center staff working~     closely with staff at each intervention hospital to discuss solutions to barriers to rapid~     treatment for STEMI patients.~   "
109339|NCT01625091|"~     The primary objective of this study is to evaluate whether an intervention that involves the~     medication naltrexone, will reduce drinking and improve health outcomes in women with HIV~     infection and hazardous drinking. Our central hypotheses are that, compared to women who~     receive placebo (sugar pill containing no medicine), women who receive naltrexone will have~     decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease~     progression, and reduced sexual risk behavior. The study design will involve 240~     HIV-infected women with hazardous drinking, who will be recruited from HIV clinics,~     neighborhoods and referrals in Miami, Florida.~      Eligible women will receive either a daily pill containing naltrexone (50mg) or an~     identical-appearing placebo for four months. All participants will receive encouragement and~     feedback related to their drinking regardless of medication assignment. The study~     participants will be assessed at two, four and seven months after enrollment. The proposed~     work is innovative because pharmacologic treatment for alcohol has not been evaluated in~     HIV-infected women. If our hypotheses are confirmed, the study findings would transform the~     approach to hazardous drinking within clinics serving HIV-infected women.~   "
109340|NCT01625078|"~     The investigators wish to accumulate initial data on the performance and safety of the Baska~     mask in paediatric patient population.~   "
109347|NCT01624987|"~     The project aims to investigate if trauma-related disorders and appetitive aggression can be~     reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure~     Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local~     personnel (phase 1). In a second step, the project aims to investigates the treatment~     success if this specific therapy is carried out by local personnel who have been trained by~     other local personnel (train the trainer, phase 2) under the supervision of experts of the~     University of Konstanz.~   "
109348|NCT01624974|"~     The purpose of this study is to evaluate the effect of MK-1029 on lung function in the~     treatment of adults who have persistent asthma that is uncontrolled with the use of~     montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo)~     for two separate 4-week treatment periods. All participants will also use ML during the~     treatment periods.~   "
109349|NCT01624961|"~     The study is designed to establish the best dose to safely infect healthy individuals with~     Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.~   "
109350|NCT01624948|"~     This study is examining the safety and efficacy of converting anti-rejection therapy from~     mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK~     virus infection.~      The study will also determine if immune monitoring tests can detect an association between~     BK virus infection and transplant rejection episodes, based on the specific BKV infection~     treatment regimen.~      The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and~     tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and~     tacrolimus + prednisone in patients who have undergone renal transplantation and have active~     BKV infections.~   "
109351|NCT01624935|"~     The enormous global burden of mental illness has been estimated through the publication of~     the Global Burden of Disease Study. Research confirms that populations exposed to mass~     trauma such as natural disaster bear a particularly high burden of mental disorders, with~     depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult~     psychiatric diagnoses. In traumatized populations, these disorders do not remit with~     replacement of material losses or resettlement to safe locations, but rather tend to become~     chronic conditions with attendant disability. PTSD and depression are risk factors for~     anger, interpersonal discord and violence, not only among those who have trauma and~     depression, but also among their spouses and children. This infectious model of~     trauma/violence is critically important in the setting of natural disaster, as increased~     levels of interpersonal violence within the afflicted community hinder its recovery. To~     date, there has been little research on the interpersonal effects of mass trauma. The~     proposed research is a randomized controlled trial of Interpersonal Therapy (IPT) versus~     wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China.~     IPT, a very effective therapy for depression, has been adapted for PTSD treatment and~     developing country settings. Measures will evaluate success of the treatment not only in~     terms of individual depression and PTSD symptoms, but also with respect to interpersonal~     functioning.~      Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet~     criteria for Depression and PTSD at the conclusion of the RCT.~      Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning~     than wait list controls.~   "
109352|NCT01624922|"~     Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a~     well-proved and booming measure in CHD management, is invasive and of high cost, however the~     knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI~     patients in 30 geographically representative highest-rank hospitals, this study will examine~     various real-life factors, that may affect patients recovery after the procedure. Practical~     guidelines, appropriateness criteria and quality evaluative system for PCI will be~     established based on the findings, to improve patients outcomes in future finally.~   "
109353|NCT01624909|"~     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,~     however little information is available about how evidence-based therapies are incorporated~     appropriately into routine clinical practice in China. In addition, basic data and evidence~     about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI~     patients in 40 hospitals of different levels, this study will examine various real-life~     factors, that may affect patients recovery after a heart attack. Practical guidelines and~     risk model for AMI patients will be established based on the findings, to improve patients~     outcomes in future finally.~   "
109354|NCT01624896|"~     Coronary heart disease (CHD) is one of the leading causes of mortality and morbidity. PCI,~     as a well-proved and booming measure in CHD management, is invasive and of high cost,~     however the knowledge about the real-life PCI use in China is limited. Within a nation-wide~     and regional representative probability sample of hospitals in China, 14,000 CAG/PCI~     inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will~     be reviewed and abstracted in the national coordinating centre, in order to evaluate the~     treatment pattern, outcomes, and cost for PCI, during the past decade. Basic data and~     innovative evidence will accelerate evidence-based clinical practice and policy making, and~     improve patients outcomes in future finally.~   "
109355|NCT01624883|"~     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,~     however the knowledge about the real-life AMI management in China is limited. Within a~     nation-wide and regional representative probability sample of hospitals in China, 27,800 AMI~     inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will~     be reviewed and abstracted in the national coordinating centre, in order to evaluate the~     treatment pattern, outcomes, and cost for AMI patients, during the past decade. Basic data~     and innovative evidence will accelerate evidence-based clinical practice and policy making,~     and improve AMI patients outcomes finally.~   "
109356|NCT01624870|"~     The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with~     the Medtronic CoreValve bioprosthesis.~   "
109357|NCT01624857|"~     Depression is frequently observed in patients with coronary heart disease (CHD) and~     represents a significant risk factor for major cardiovascular events. Previous study has~     proved that high sensitive C-reactive protein (hsCRP) was an independent predictor for~     depression in CABG patients at 6 months after bypass surgery. Statins can effectively reduce~     the blood levels of hsCRP. This study aim to examine whether statins can improve the~     prognosis of depressive patients undergoing coronary artery bypass surgery through reducing~     the levels of hsCRP.~   "
109358|NCT01624844|"~     The purpose of this study is to investigate whether the dural sac volume as determined by a~     geometrical calculation following multilevel measurements of its transverse area and length~     by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric~     bupivacaine in a non-obstetrical population.~   "
109359|NCT01624831|"~     In the current study, the investigators propose to measure the five domains of social~     cognition identified by the National Institute of Mental Health (NIMH) as relevant to~     individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition,~     social perception, and social knowledge). The investigators will also explore the~     association between different domains of social cognition and outcomes relevant to psychotic~     disorder (e.g., symptomatology, social functioning, and vocational functioning).~   "
109360|NCT01624818|"~     Background: In Norway each year 130-150 children are born with heart disease that requires~     lifelong medical follow-up. Children with heart defects have reduced motor skills and~     reduced physical capacity compared with healthy peers. Increased knowledge in the children~     themselves and the general public, along with psychosocial interventions improve the child's~     ability to cope with the consequences of their disease. Descriptions of the experiences that~     Norwegian children with heart disease and their parents have about participation in~     rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in~     rehabilitation of children with chronic illness, and started in 2005 to welcome children~     with heart disease. At present there is no rehabilitation institutions in Norway that has a~     special group programs for children with heart disease. Geilomo want to establish such a~     group for children aged 6-7 years and 11-12 years.~      Main objective: The investigators will use of methods to learn more about the following:~      Study 1: The purpose is to generate knowledge about how children with heart disease and~     their relatives experience participation in a rehabilitation program at Geilomo children's~     hospital.~      Overarching question: How do children with heart disease and their guardians to participate~     in a rehabilitation program, and the impact of this on their daily life afterwards?~      Study 2: The purpose is to help a) to give the children an increased level of activity in~     the home environment.~      Question: Will children with heart disease increase their activity levels at home after a~     stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will~     children with heart disease have improved their physical condition three months after a stay~     at Geilomo?~      Work schedule: The project will have a duration of 3 years. The project will seek approval~     of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide,~     information sheet and consent form has been prepared. Data collection for the study 2AB can~     start in March 2013. The first interviews will be conducted after 3 months, in June 2013.~     Data collection is expected to be completed in December 2013. The analysis will take place~     in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3~     pieces) and publication of results.~      Method: In order to shed light on the problem in study 1, the investigators will use~     semi-structured interview. 16 children and 16 parents to be interviewed after 3 months.~     Study 2a) To get information about their child's activity level in the home environment the~     investigators will use structured questionnaires. It is one form for children (36 persons)~     and another form for their parents (36 persons). Study 2b) All children (36 persons)~     conducting physical fitness test at the first visit and after three months. Children can be~     referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle~     Hirth (HUS) determines participation according to inclusion and exclusion criteria.~      Parents submit a written consent on behalf of themselves and their children.~      Scientific significance: This application describes two related studies, both of which are~     expected to provide important information that can provide better services for children with~     heart disease.~   "
109361|NCT01624805|"~     The goal of this clinical research study is to learn if horse anti-thymocyte globulin~     (hATG), given in combination with methylprednisolone, cyclosporine, and G-CSF (filgrastim or~     pegfilgrastim), can help to control AA and/or low-int-1 risk MDS. The safety of this drug~     combination will also be studied.~      hATG is made from horse blood and targets immune cells known as T-lymphocytes. Since~     T-lymphocytes are believed to be involved in causing low blood counts in AA and in some~     cases of MDS, killing these cells may help treat the disease.~      Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This~     may help to improve low blood counts in AA and in some cases of MDS.~      Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help~     to fight infections and help improve the white blood cell count.~   "
109362|NCT01624792|"~     Loss of muscle protein is generally a central component of weight loss in Chronic~     Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve~     in COPD unless specific metabolic abnormalities are targeted. The investigators recently~     observed that alterations in protein metabolism are present in normal weight COPD patients.~     Elevated levels of protein synthesis and breakdown rates were found in this COPD group~     indicating that alterations are already present before muscle wasting occurs. The~     investigators recently observed that in order to enhance protein anabolism, manipulation of~     the composition of proteins and amino acids in nutrition is required in normal-weight COPD.~     Intake of casein protein resulted into significant protein anabolism in these patients. The~     anabolic response to casein protein was even higher than after whey protein intake.~      A substantial number of COPD patients, underweight as well as normal weight to obese, is~     characterized by an increased inflammatory response. This group failed to respond to~     nutritional therapy. Previous experimental research and clinical studies in cachectic~     conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to~     attenuate protein degradation by improving the anabolic response to feeding and by~     decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with~     docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several~     disease states, however weight and muscle mass gain was not present or minimal.~      Until now, limited research has been done examining muscle protein metabolism and the~     response to EPA and DHA supplementation in patients with COPD.~      It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients~     during 4 consecutive weeks will increase the muscle anabolic response to a high quality~     protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will~     increase the anabolic response even further. In the present study both the acute and chronic~     effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be~     examined. The principal endpoint will be the extent of stimulation of net fractional muscle~     protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on~     muscle anabolism can be measured. The endpoint will be assessed by isotope methodology which~     is thought to be the reference method.~   "
109363|NCT01624779|"~     The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal~     stem cells in the patients with spinal cord injury, Phase I Clinical study.~   "
109364|NCT01624766|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Afinitor (everolimus) either with Kineret (anakinra) or Xgeva (denosumab)~     that can be given to patients with advanced cancer. The safety of these drugs will also be~     studied.~      Everolimus is designed to stop cells from dividing.~      Anakinra is designated to block a protein that is involved in tumor development, new blood~     vessels growing, and spread of cancer.~      Denosumab is designed to block the activity of a protein, which may prevent bone~     complications in cancer that has spread to the bone.~   "
109365|NCT01624753|"~     Fibered confocal fluorescence microscopy (FCFM) (CellvizioR Lung, MaunaKea Technologies,~     France) could potentially provide diagnostic information on fibrosis and inflammation of the~     distal air spaces associated with diffuse parenchymal lung diseases without the need for~     lung biopsies, thereby fulfilling the gap in the investigators current medical practice of a~     minimally invasive procedures with few complications and a high diagnostic fidelity.~      In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup,~     the investigators will offer the patient concurrent FCFM imaging to be performed during the~     bronchoscopic procedure. The investigators aim to identify and catalogue distinct and~     discriminating features seen on images obtained from fibered confocal fluorescence~     microscopy in this group of patients, and to correlate these findings with specific high~     resolution computed tomography (HRCT) features and pathological findings if available.~     Eventually the investigators hope to create diagnostic criteria for fibered confocal~     fluorescence microscopy image interpretation of specific diffuse parenchymal lung disease~     entities.~   "
109366|NCT01624740|"~     To determine the effects of varying spinal cord stimulation programming parameters,~     including stimulation rate, on pain intensity.~   "
109368|NCT01624714|"~     The purpose of this study is to treat prospectively documented clinic patients with~     treatment-refractory multiple sclerosis that are naïve to alemtuzumab. Alemtuzumab shows~     efficacy and rate of serious adverse events (SAEs) which is equivalent or better than~     standard of care treatment strategies used previously for treatment-refractory multiple~     sclerosis.~   "
109369|NCT01624701|"~     This is a pilot clinical trial to assess the feasibility and efficacy of expanding umbilical~     cord blood derived blood stem cells for transplantation using a combination of chemical~     factors and stromal co-culture. Bone marrow (BM) mesenchymal stromal cells (MSC) will be~     obtained from a separate bone marrow donor. One cord blood unit will be expanded by this~     method while another cord blood unit will be infused without manipulation. The expanded cord~     blood unit will help boost the initial recovery of blood counts after transplantation,~     though it is expected that the unexpanded cord blood unit will provide the cells which will~     lead to long term engraftment of blood stem cells. A third cord blood unit will be~     identified for standby should the cord blood unit expansion fail.~   "
109370|NCT01624688|"~     The purpose of this study is to combine treatment options for tattoo removal in an attempt~     to completely remove a tattoo in one visit.~   "
109371|NCT01624675|"~     The purpose of this study is to evaluate the efficacy of risperidone compared with placebo~     in children and adolescents with irritability associated with autistic disorder.~   "
109372|NCT01624662|"~     The primary objective of this study is to compare the efficacy of intranasal administration~     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device with placebo in subjects with bilateral nasal polyposis.~   "
109373|NCT01624649|"~     The purpose of this observational study is to explore the efficacy of methylphenidate~     hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity~     disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time~     version (K-SADS-PL).~   "
109374|NCT01624636|"~     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and~     efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with~     neovascular age-related macular degeneration (AMD)~   "
109375|NCT01624623|"~     This study will evaluate the daily use of a unique daily organ tracking system on target~     localization in patients treated with radiation therapy after radical prostatectomy for~     prostate cancer.~      Improved coverage of the target volume with radiotherapy could result in improved cancer~     control rates and decreased coverage of surrounding structures potentially decreasing~     treatment toxicity.~   "
109376|NCT01624610|"~     The purpose of the study is to find out if the diets often recommended for patients with~     Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will~     compare two diets that are used to treat IBS-D symptoms to see which one is more effective.~     The study will also measure the effect of these diets on the bowel flora, which are the good~     bacteria that inhabit the bowels in healthy people.~   "
109377|NCT01624597|"~     This randomized controlled trial will evaluate an intervention that provides parents with~     objective feedback about their teen's driving as well as strategies to improve communication~     with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent~     or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have~     reduced driving errors and increased safety behaviors than dyads with no feedback; and,~     parent-teen dyads who receive instruction on communication techniques will have improved~     quality and quantity of communication about driving than dyads not learning these~     techniques.~   "
109378|NCT01624584|"~     First, can exposure therapy for childhood anxiety begin earlier in the course of treatment~     than current treatment manuals suggest?~      Second, is treating childhood anxiety with exposure therapy more effective and efficient~     than treating childhood anxiety with relaxation training + cognitive restructuring?~   "
109379|NCT01624571|"~     This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement~     of gastrointestinal motility between each dose group by comparing the effectiveness and~     safety in patients undergoing colon resection.~   "
109380|NCT01624558|"~     Malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to~     volatile anesthetic gases, most commonly recognized in children during anesthesia. Carbon~     filters have been used to scavenge various gases. A new carbon filter (Vapor Clean,~     Dynasthetics, LLC, Salt Lake City, Utah) with a 510(k) clearance specifically for scavenging~     anesthetic gases is being marketed, though the filter itself has never been studied in vivo.~     Bench studies conducted by the manufacturer of the product demonstrate it is extremely~     effective in reducing the volatile gas output from an anesthesia machine within 2 minutes.~     This pilot study will measure the effect on volatile gas concentration in non-malignant~     hyperthermia susceptible patients. Twelve (12) patients will undergo standard anesthetic~     induction using inhalational anesthetic (Sevoflurane®) and maintained on 3% for 30 minutes~     to attain steady state concentrations.1 At that time, a total intravenous anesthetic~     technique will be started and maintained throughout the case. Simultaneously a Vapor Clean~     filterset will be placed in the breathing circuit (inspiratory and expiratory limbs).~     Volatile gas concentration will be measured and recorded. This research will determine the~     feasibility of using this carbon filter to quickly reduce the breathing circuit gas~     concentration of volatile anesthetic in the clinical setting. This is fundamental in~     establishing this as a key life saving measure in eliminating the stimulus in a malignant~     hyperthermia event.~   "
109406|NCT01624220|"~     The goal of the first part of this clinical research study is to learn how to deliver more~     accurate radiation treatment of tumors in the spine. Researchers also want to learn how~     internal organs might move during radiation treatment.~      The goal of the second part of this study is to learn if it is safe to allow slightly more~     radiation to the normal esophagus when spinal tumors close by are being treated. This may~     result in better tumor control.~   "
109407|NCT01624207|"~     The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded~     formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic~     Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly~     higher in Atorva group. Both treatments were well tolerated.~   "
109950|NCT01617096|"~     This is a double-blind, randomised, placebo-controlled study to assess the safety and~     efficacy of a silicone elastomer vaginal matrix ring.~   "
109381|NCT01624545|"~     Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These~     hematomas develop after minor head trauma and increase in size over weeks. Patients usually~     present with headaches, gait disturbances, language problems or confusion. The state of the~     art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr~     hole trepanation.~      The optimal follow-up for operated patients remains controversial. Due to the known high~     rate of a second hematoma at the same place (usually within weeks), one strategy is to~     perform serial computer tomography scans in order to identify recurrent hematomas early. The~     radiologic evidence of a second hematoma often leads to reoperation, even if the patient has~     no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to~     closely follow the patient with neurological examinations and perform neuroimaging only in~     case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT~     scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in~     a patient population marked by advanced age and fragility.~      The aim of the current study is to evaluate the role of computer tomography scanning in the~     postoperative follow-up after removal of a chronic subdural hematoma. Participants of this~     study will be allocated by chance to one of two study groups: Patients allocated to group A~     will receive a computer tomography scan on day 2 and again on day 30 after surgery in~     addition to a clinical examination. Patients allocated to group B will be examined~     clinically on day 2 and day 30 without computer tomography. All patients will undergo a~     final clinical examination after 6 months. The study will recruit 400 patients.~   "
109382|NCT01624532|"~     The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the~     Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.~   "
109383|NCT01624519|"~     The main objective of this study is to examine the agreement between arterial, central~     venous, and peripheral venous lactate values in a population of medical Intensive Care Unit~     (ICU) patients.~   "
109384|NCT01624506|"~     The Anti-Reflux Surgical Study has been established to:~        -  Collect data about anti-reflux surgical treatment options (magnetic sphincter~          augmentation and Fundoplication) in everyday clinical practice~        -  Track the clinical course of patients from pre-operative assessment to three years~          post-surgery~   "
109385|NCT01624493|"~     This phase I/II trial will determine the recommended dose and activity of BNC105P for~     patients with partially platinum sensitive ovarian cancer in first or second relapse.~   "
109386|NCT01624480|"~     This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and~     multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with~     excessive sleepiness associated with narcolepsy.~   "
109387|NCT01624467|"~     The purpose of this study is to determine whether treatment with necitumumab monotherapy~     affects the QT/QTc interval among participants with advanced solid tumors refractory to~     standard treatment or for which no standard treatment is available.~   "
109388|NCT01624454|"~     Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel~     cleansing, randomizing adult outpatients by invitation letter~   "
109389|NCT01624441|"~     This phase I clinical trial studies the side effects and the best dose of dinaciclib when~     given together with epirubicin hydrochloride (epirubicin) in patients with metastatic~     (cancer that has spread to other parts of the body) triple-negative breast cancer.~     Dinaciclib is designed to stop cancer cells from dividing into new cancer cells. Epirubicin~     is designed to block the way cancer cells grow and divide and may slow or stop cancer cells~     from spreading throughout the body. Researchers want to find out what is the highest~     tolerable dose of the experimental drug dinaciclib that can be given in combination with~     epirubicin in patients with metastatic triple negative breast cancer.~   "
109390|NCT01624428|"~     This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the~     influence of varenicline on reward processing, cognitive control, and regulation of craving~     in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when~     compared with those receiving placebo, will have differential brain responses to~     anticipation of rewards, during exposure to the Stroop task, and in response to tobacco~     cues.~   "
109391|NCT01624415|"~     Humans attain binocular vision from the two retinal images of both eyes through a series of~     sensory and motor processes that culminate in the perception of stereoscopic depth. Looking~     at a scene creates two slightly different images on the retinas which is due to the eyes'~     different positions on the head. This so called binocular disparity provides information to~     calculate depth and therefore enables stereopsis. Physiologically the two retinal images are~     superimposed and merge into one stereoscopic image.~      If one image is presented to one eye in an experimental setting, and a completely different~     image is presented to the other eye, the investigators visual system, analogous to diplopic~     vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular~     rivalry occurs. Here, both images are seen alternating and the brain can switch back and~     forth between these images.~      The aim of the present study is to investigate the effects of objective changes to image~     quality on the investigators subjective stereoscopic perception. This psychophysiological~     testing is done by looking at different images and thereafter by subjective grading of the~     image quality.~      The investigators hypothesize that overlapping image modifications occurring in both eyes~     are detected immediately, but changes, that are rotated by 90 degrees against each other,~     should be suppressed and result in one stereoscopic image, reduced in image quality. Whether~     this also accounts for more detailed images, such as reading cards, is questionable.~   "
109392|NCT01624402|"~     Older adults who are stroke survivors can experience many challenges, including depression,~     cognitive dysfunction, and physical disability. Family members and other caregivers may~     struggle with helping stroke survivors adjust to life after stroke. This research study~     involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy~     (EFT) to help treat depression in older adult stroke survivors. EFT teaches problem-solving~     skills to patients to help them cope with problems related to stroke and depression, alters~     their physical environment to accommodate new needs resulting from stroke, and helps the~     family or caregiver to assist in the patient's adaptation. In addition this study will~     compare EFT to an education intervention to see which is more effective in treating~     depressed stroke survivors.~   "
109393|NCT01624389|"~     Alzheimer's disease (AD) may be one of the most pressing problems facing all countries~     around the world as the population ages.AD is a slowly evolving process that likes begins~     years to decades before the clinical symptoms area manifest. However, as one would like to~     identify the disease process at an earlier point in the clinical continuum, the precision of~     the diagnosis is reduced. Therefore, the challenge is to try to identify the process at the~     pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of~     imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to~     characterize subjects at an early clinical phase of AD and subjects with MCI have been a~     target for prevention trials. There are two pathological landmarks, in terms of~     extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present~     symptomatic treatments provide some benefit to patients with AD, they are not the solution~     for AD. Up to date, there are still no therapies can alter the underlying nature of the AD~     process. Therefore, the earlier the intervention takes place, presumably, the greater the~     protection against further neuronal damage will be appreciated.The Alzheimer's Disease~     Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the~     United States and Canada established to develop standardized imaging techniques and~     biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI~     has been a groundbreaking project, establishing pre-competitive collaboration and real-time~     data sharing among academia and industry investigators to clarify the relationships among~     demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout~     the course of AD neurobiology, in order to facilitate the development of effective~     therapeutics.This project has exceeded expectations, providing insights into disease~     mechanisms as well as hugely valuable advances, based primarily on the use of standardized~     biomarkers, to drug development programs. A number of the leading disease-modifying drug~     development programs are now employing ADNI methodology toward more efficient trial design,~     particularly in the critically important early (pre-dementia) AD population~   "
109394|NCT01624376|"~     The primary objective of this study is to investigate the safety and tolerability of locally~     administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.~      The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period~     and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after~     the last study visit.~   "
109395|NCT01624363|"~     The investigators are interested in performing a detailed examination of the pancreas via~     EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The~     hypothesis is to make a statistical determination of how many pancreatic cysts the~     investigators discover incidentally.~   "
109396|NCT01624350|"~     This will be a prospective, multi-center, post-market, single arm observational study to~     collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of~     anorectal fistulas.~      The subjects will have baseline and day of surgery visits performed, and then subjects will~     return to the investigator for evaluation of defect and safety related morbidities at follow~     up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.~   "
109397|NCT01624337|"~     Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.~   "
109398|NCT01624324|"~     The aim of this study is to determine whether the plasma concentration of aminoglycoside in~     Indonesia neonates with infection are within safe and effective range and its association~     with cochlear toxicity and nephrotoxicity.~   "
109399|NCT01624311|"~     This is a pilot study which will test the safety and feasibility of hypothermia treatment as~     adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates~     versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs)~     only. The endpoint of the pilot study will be reached when either 24 patients have been~     enrolled and no serious adverse events were observed, when no patient has been enrolled in 5~     years, or when serious adverse events occur which are clearly linked to the use of~     hypothermia. These would be serious complications not seen in patients on conventional~     therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.~   "
109400|NCT01624298|"~     The purpose of this study is to study the effectiveness of Trauma Focused Cognitive~     Behavioral Therapy in subset of children who are affected by trauma with significant mental~     health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the~     severity of mental health symptoms experienced by traumatized children and adolescents in~     Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors~     and increasing coping strategies and health promotion activities in traumatized children and~     adolescents in Lusaka. The study will be integrated into current programing of the Serenity~     Harm Reduction Programme, a community and faith based organization focusing on mental health~     and substance use prevention and treatment, and its partners in 5 compounds.~   "
109401|NCT01624285|"~     The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and~     effective treatment option for preventing liver cancer in high risk patients following liver~     transplantation. Liver transplantation is a treatment option for liver cancer patients, but~     despite transplantation, the liver cancer can recur in the new, transplanted liver. It is~     not known whether sorafenib is effective in preventing cancer recurrence in high risk~     patients following liver transplantation~   "
109402|NCT01624272|"~     The global loss of muscle mass and strength associated with aging is a cause of functional~     impairment and disability, particularly in the frail elderly. Respiratory function can be~     severely compromised if there is a decrease of respiratory (RM) strength complicated by the~     presence of comorbidities and physical immobility.~      Previous studies have shown that the specific RM training is an effective method to increase~     RM strength, both in healthy people and patients. In this case, specific RM training may be~     regarded as a beneficial alternative to improve RM function, and thus prevent physical and~     clinical deterioration in this population.~      The hypothesis is that specific RM training would improve RM strength and endurance in the~     experimental groups vs. control who do not participate in RM training.~      Institutionalized elderly people with an inability to walk were randomly allocated to a~     control group, a Threshold group or a Pranayama group. Both experimental groups performed a~     supervised RM training, five days a week for six consecutive weeks. The maximum inspiratory~     and expiratory pressures (MIP and MEP) and the maximum voluntary ventilation (MVV) were~     assessed at four time points in each of three groups.~   "
109403|NCT01624259|"~     The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide~     compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate~     glycemic control on metformin.~   "
109404|NCT01624246|"~     To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with~     augmented renal clearance (ARC).~   "
109405|NCT01624233|"~     This study will assess the safety and efficacy of ixekizumab in participants with moderate~     to severe psoriasis in Japan.~   "
109408|NCT01624194|"~     Autism is a pervasive developmental disorder characterized by core deficits in social~     behavior and communication, and the presence of repetitive or stereotyped behaviors. It is~     one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88~     children in the United States. At present, pharmacotherapies target only associated features~     of autism, with no effective drug treatments for the social impairments. Several lines of~     evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for~     the core social deficits in autism. Here we will test the effects of twice daily intranasal~     OT (24 IU) over a 4-week period for enhancing social deficits in male and female children~     aged 6-12 years with autism. This research has high potential to lead to the development of~     more effective treatments and earlier interventions for children with autism.~   "
109409|NCT01624181|"~     With this study the investigators want to determine, if a fast identification of germs,~     causing hospital-acquired infections of the lower respiratory tract, is possible through the~     use of MCC-IMS technology - a method that allows on time detection and identification of~     very small amounts of substances in gas samples. Therefore aspiration samples from the~     respiratory tracts of ventilated patients, which are suspected to develop such an infection,~     will be collected, cultivated and analyzed by MCC-IMS. The investigators want to determine~     if MCC-IMS diagnostic could be a faster alternative to conventional microbiological methods.~     The results of the MCC-IMS analyses therefore will be compared with results of conventional~     microbiological methods.~   "
109410|NCT01624168|"~     The purpose of this study is to determine the feasibility of a 10-week tai chi chuan~     intervention as a treatment for anxiety and sleep quality in young adults.~   "
109411|NCT01624155|"~     Typically, the CTIS Pregnancy Health Information Line in the Department of Pediatrics,~     School of Medicine at the University of California educates pregnant women who call the~     Information Line after an exposure to a medication that might be harmful to the developing~     baby has already taken place, and therefore the opportunity for prevention of that exposure~     no longer exists. Frequently these pregnancies are unintended and occur due to the lack of~     effective contraceptive use. This study facilitates patient access at UCSD to specialized~     and individualized contraceptive counseling for women of reproductive age who are currently~     taking a medication that might be risky in a future pregnancy. This study also measures the~     impact of individualized contraceptive counseling in changing contraceptive behavior.~      Primary Hypothesis: EPIC (EMR)/physician-facilitated referral of female patients of~     reproductive age to an existing specialized counseling service at UCSD will improve the~     utilization of more effective contraception among women of reproductive age who are~     prescribed medications that might be harmful to the developing fetus.~   "
109412|NCT01624142|"~     A study to assess the long term safety and efficacy of Evolocumab (AMG145)on Low Density~     Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.~   "
109413|NCT01624129|"~     The purpose of the study is to investigate if serological parameters such as extracellular~     Serum-Tryptase (ST) and eosinophilic cationic protein (ECP) are useful for the diagnosis~     and surveillance of the eosinophilic esophagitis (EE).~   "
109414|NCT01624116|"~     Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control~     between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in~     fasting diabetics is to identify which treatment modality leads to the most stable blood~     glucose levels during a fast and how to smooth out these excursions and reduce risks of fast~     to a minimum.~   "
109415|NCT01624103|"~     Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux,~     September 2012.) showed significant difference in Comfort Score during Ultrasound Guided~     Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population.~     However, it is unknown whether the difference in Comfort score (1) was associated with~     reduction of local anesthetic (LA) volume in elderly or it is attributed to elderly~     population by itself. The aim of the study is to compare the Comfort score during US-SCB~     placement in elderly patients undergoing upper limb surgery performed with two different~     volumes of local anesthetics (20 ml vs 32 ml).~   "
109416|NCT01624090|"~     Background:~      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted~     against some forms of cancer, but was never accepted as a treatment. Research suggests that~     it may be useful against some cancers of the chest, such as lung and esophageal cancer or~     mesothelioma. Researchers want to see if mithramycin can be used to treat these types of~     cancer.~      Objectives:~      - To see if mithramycin is safe and effective against different chest cancers.~      Eligibility:~      - Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum~     cancers.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor tissue samples will be used to~          monitor the cancer before treatment.~        -  Participants will receive mithramycin every day for 7 days, followed by 7 days without~          treatment. Each 14-day round of treatment is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the drug for as long as the side effects are not~          severe and the tumor responds to treatment.~   "
109417|NCT01624077|"~     The first trial will involve the generation of donor alloantigen-specific CD4+CD25+ Tregs~     from peripheral blood of pre-transplant patients, the administration of the CD4+CD25+ Tregs~     (1 x 106 cells/kg) at several intervals (for graft specific tolerance induction).~   "
109418|NCT01624064|"~     Enalapril would significantly reduce progression of renal disease in patients with Chronic~     Kidney Disease of Uncertain aetiology.~   "
109430|NCT01623895|"~     To investigate effect of genetic variations on the toxicities and find optimal target~     population, the investigators planned to analyze the genetic polymorphisms of~     UDP-glucuronosyltransferase.~   "
109431|NCT01623882|"~     The primary purpose of this study is to evaluate the safety and efficacy of the concurrent~     use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous~     stasis lower extremity ulcers.~   "
109432|NCT01623869|"~     This phase II trial studies how well trebananib works in treating patients with advanced~     angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor~     cells by blocking blood flow to the tumor.~   "
109419|NCT01624051|"~     Cancer patients are highly variable in their body composition, specifically in the~     proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body~     mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia.~     Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose~     reductions and stopping of treatment, and have reduced survival. One potential explanation~     for this is that patients with sarcopenia have a reduced volume of lean body mass into which~     chemotherapy drugs are distributed, resulting in a higher concentration and greater~     toxicity. This study will randomize lung cancer patients to either the standard dosing~     strategy based on body surface area or experimental, personalized dosing based on lean body~     mass. Based on retrospective findings in this patient population, the investigators expect~     to find that severe toxicity will be reduced for sarcopenic patients on the personalized~     dosing arm based on lean body mass.~   "
109420|NCT01624038|"~     The study hypothesis that treatment with Erythropoietin (EPO) combined with Human~     Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia~     intermedia patients.~      Second is to determine whether any of the following correlate with improved hematologic~     response:~      A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline~     levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte~     counts (or % circulating nucleated erythroblasts/100 WBCs).~      Goal:~      The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia~     intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea~     and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion~     requirements during study period. Also to report and compare adverse events with other~     published data regarding.~   "
109421|NCT01624025|"~     A salvage treatment with combination of docetaxel and epirubicin in patients with~     unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based~     study~   "
109422|NCT01624012|"~     The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is~     better in noninvasive ventilation of premature infants than currently used Nasal Continuous~     Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.~      The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more~     synchronous with patient, which will lead to a decrease in need of inspired oxygen.~   "
109423|NCT01623986|"~     The purpose of this clinical study is to investigate if central venous pressure (CVP)~     measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP)~     when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.~   "
109424|NCT01623973|"~     To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that~     could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify~     the impact on daily function, quality of life. In this pilot, randomized, blind and~     allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly~     assigned, after the first evaluation, into two groups: group without restriction (G1),~     subject only to the specific training of paretic UL, and restricted group (G2), which~     underwent specific training of paretic UL and use of the restriction of non paretic UL~   "
109425|NCT01623960|"~     The primary aim of this study is to evaluate the overall quality of life in adult patients~     with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and~     to assess the impact of certain disease and drug related factors (treatment modality,~     presence of viral disease, inhibitor, etc.) on the quality of life.~   "
109426|NCT01623947|"~     Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve~     cycling performance and mental acuity in a dose-dependent response.~   "
109427|NCT01623934|"~     This study includes 2 phases. During phase 1, pregnant women are followed over the course of~     pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3 and 5 year after~     delivery.~      The purpose of this phase 1 is to :~        -  assess the contribution and interactions of adipokines in the development of insulin~          resistance during pregnancy and gestational diabetes;~        -  assess levels of maternal adipokines as determinants of development and fetal growth;~        -  determine the genetic variations that influence levels of adipokines and glucose~          regulation during pregnancy and in newborns.~      The purpose of this phase 2 is to:~        -  identify DNA methylation variations at birth that are predictive of childhood~          overweight/obesity.~        -  identify maternal characteristics associated with DNA methylation variations predictive~          of childhood overweight/obesity.~        -  establish whether the loci predictive of childhood overweight/obesity at birth are~          still differentially methylated at 5 years of age (samples collected at 5 years of~          age).~        -  identify DNA methylation variations at birth that are predictive of childhood~          neurodevelopment problems at 3 and 5 years of age.~   "
109428|NCT01623921|"~     Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the~     leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with~     recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2)~     is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2~     plays an important role in the pathogenesis of acute lung injury (ALI).~      Aims: The current study aims at evaluating the beneficial effects of statins and COX-2~     receptor inhibitors on ALI elicited by blunt trauma to the chest.~      Methods: After approval by the institutional ethics and a scientific committee, and~     obtaining informed consent , patients admitted to the emergency department (ED) due to blunt~     trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of~     statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and~     measuring inflammatory mediators levels in the serum and in the bronchoalveolar space.~      Expected results: The investigators expect to find that the proposed treatment will be~     effective in reducing ALI burden. The investigators also suppose that using a combination of~     those drugs will synergistically potentiate their effect on ALI.~   "
109429|NCT01623908|"~     The main purpose of this study is to observe and assess the impact of adjuvant zoledronate~     on bone density in breast cancer patients.~      The second purposes:~        -  The efficacy of adjuvant zoledronate~        -  The safety of adjuvant zoledronate~        -  The bone loss of breast cancer patients in Guangdong~        -  The correlation between bone loss of breast cancer patients and treatment of disease in~          Guangdong~   "
109434|NCT01623843|"~     The purpose of this study is to determine whether surgical correction of hip impingement~     morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved~     clinical results (decreased pain and improved function) in adult patients with~     femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful~     inflammation debris) and treating obvious damage of the hip joint.~   "
109435|NCT01623830|"~     The overall aim of this project is to determine if using a cue to trigger (and reactivate)~     the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in~     patients with a fear of flying. The long term goals are to establish if targeting the~     reconsolidation of fear with a reminder of the fear is effective for human clinical~     populations in reducing relapse (return of fear). In this investigation, the investigators~     propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality~     exposure therapy (VRE). All patients in the study will receive exactly the same exposure~     treatment using a virtual airplane.~   "
109436|NCT01623817|"~     The goal of tish clinical research study is to identify that loading of vancomycin can~     faciliate rapid attainment of target trough serum vancomycin concentration.~   "
109437|NCT01623804|"~     The purpose of this pilot study is to determine the feasibility of conducting a high quality~     clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee~     osteoarthritis pain and physical function.~   "
109438|NCT01623791|"~     The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria,~     random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300~     mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe~     preeclampsia. The cross-sectional longitudinal study design used, 209 patients with~     pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random~     urine samples were taken before the 24 hour urine collection for spot urine analysis for~     evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in~     all patients as the gold standard of the urine total proteinuria.~   "
109439|NCT01623778|"~     Along with the improvement of the accuracy of detection of HBV serological markers, the~     optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection~     becomes feasible. Currently, the recommendation of optimized treatment especially interferon~     therapy are mainly based on retrospective studies, it still lacks prospective evidence. This~     study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks~     optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg~     positive CHB with inadequate response to 24 weeks interferon treatment.~   "
109440|NCT01623765|"~     To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or~     staging of suspected lung cancer~   "
109441|NCT01623752|"~     It is known from the COMET-trial that patients who start Enbrel treatment early have a great~     chance of reaching clinical remission and radiographic nonprogression. It is still unclear,~     however, how many patients with early arthritis achieve remission and radiographic~     nonprogression under the conditions of routine rheumatologic care and the local~     recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).~      Therefore, no robust x-ray data are available to show/demonstrate~        -  the average extent of x-ray damage in routine patients on Enbrel outside clinical~          studies.~        -  if the outstanding effect on structural damage of Enbrel can be reproduced in routine~          practice.~        -  that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also~          for day-to-day decision making.~        -  the optimal onset of Enbrel treatment in the course of the disease to prevent~          radiographic damage~   "
109442|NCT01623739|"~     The investigators are asking subjects to take part in a research study of soft tissue (gums)~     and bone (jawbone) healing around dental implants following tooth extraction. The~     investigators want to compare how the gums and the bone changes shape with healing in two~     different scenarios:~        1. When the implant is placed at the same time the tooth is extracted.~        2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before~          the implant is placed.~      Previous studies have shown that both methods work and can give good results. In fact the~     two methods are used routinely as part of standard care but it is not known if the two~     procedures are equally good since they have never been compared in one same research study.~   "
109443|NCT01623726|"~     The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as~     complementary therapeutic tool in the treatment of schizophrenia. Patients will be~     randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main~     outcome will be measured by specific clinical rating scales based on the assessment of~     negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology.~     Secondary outcomes shall include collateral effects evaluation, anxiety and depressive~     scales as well as clinical monitoring.~   "
109444|NCT01623713|"~     The purpose of this study is to determine whether iloperidone is effective in the treatment~     of Schizophrenia.~   "
109445|NCT01623700|"~     This observational study will based on the Register of Information and Knowledge About~     Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and~     Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for~     Enhancement and Development of Evidence-based care in Heart disease Evaluated According to~     Recommended Therapies (SWEDEHEART).~      The aim of this study is to investigate the impact of different antithrombotic treatment~     options (treatment duration, type of treatment and combination of treatments) in Acute~     Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and~     mortality.~   "
109446|NCT01623687|"~     What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum,~     compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months~     after surgery?~   "
109447|NCT01623674|"~     The aim of the study was to asses the effect of sleep deprivation during nightshift by~     monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first~     day was pre call= day 1, second day was on call= day 2, third day was the first post call~     day = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in~     order to asses how performance was on call compared to pre call and post call. The~     hypothesis was that they would perform worse on call than pre call, and again slightly worse~     post call.~   "
109448|NCT01623661|"~     Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of~     sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy~     subjects.~      Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be~     measured after an infusion with hypertonic saline in CKD patients and healthy subjects.~   "
109449|NCT01623648|"~     The investigators hypothesis is that eating whey protein in the breakfast versus other~     proteins will results in higher satiety, reduced overall postprandial glycemia and more~     weight loss in obese diabetic individuals~   "
109450|NCT01623635|"~     Pain following laparoscopic surgery continues to be a clinically important problem with 80%~     or more patients requiring opioid analgesia post-operatively to control their pain. By~     reducing this surgical complication patients can experience less discomfort and be~     discharged from the recovery room more rapidly leading to reduced resource utilization and~     expense.~      HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical~     anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve~     endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision~     METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine)~     delivered directly onto the target sites both at the beginning and the end of surgery in~     patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign~     pathology. The drug will be delivered using a CE approved delivery system that will direct a~     fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the~     cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).~      GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative~     pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for~     uterine or adnexal benign pathology~   "
109451|NCT01623622|"~     The purpose of this study is to investigate the efficacy and safety of HC-58 in patients~     with severe upper limb hemiplegia following stroke.~   "
109452|NCT01623609|"~     The purpose of this study is to demonstrate the Bioequivalence, assess food administration~     on the Pharmacokinetics with naloxegol.~   "
109453|NCT01623596|"~     A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to~     fingolimod or approved disease modifying therapy. Patients will be be treatment naive or~     have only been treated with one class of DMT (Interferon beta preparation or glatiramer~     acetate) . Patients will be able to switch to different treatment for safety, efficacy,~     tolerability or convenience during the study.~      Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on~     treatment. Secondary objectives are to compare reasons for discontinuation, adverse events,~     cognitive impairment, medication satisfaction and change in brain volume measured by MRI.~   "
109454|NCT01623583|"~     An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a~     superior option for delivery of dialysis, but requires needles to be inserted. Patients on~     dialysis who indicate fear of needles as the reason for not switching from a long-term~     central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the~     eligibility criterial will be asked to participate. Patients will receive either a standard~     or an enhanced intervention to address their fear of needles. The enhanced intervention~     includes the standard intervention plus video training about Synera and trying out an actual~     patch. Over the 4 months following the intervention, how many patients sign up to switch~     access will be tracked.~   "
109455|NCT01623570|"~     The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio~     with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH~     women.~      This open-label monocentric, randomized comparative trial, to receive the two different~     standard clinical practice treatments:~        -  1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)~        -  2 vials of Menopur: (vials/powder hMG 75IU).~      Follicular development were monitored until the protocol hCG requirement is met and a single~     injection of hCG was administered.~      Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm),~     pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25~     nanomole/Liter (nmol/L).~   "
109456|NCT01623557|"~     This study aims to assess the safety and effectiveness of four new candidate malaria~     vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & MVA ME-TRAP. These vaccines consist of viruses~     (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans~     and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP).~     The hope is that these vaccines will induce immune responses in vaccinees that are able to~     prevent malaria.~      This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria~     infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.~      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology~     and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility~     in Southampton, UK. The malaria challenge will take place at the insectary at Imperial~     College (Infection and Immunity Section) in London, UK.~   "
109457|NCT01623544|"~     The objective of this study is to compare the real-world effectiveness of BFC and FSC in~     asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan~     enrollees.~   "
109458|NCT01623531|"~     The aim of the study is to show that first line treatment with concentrated fibrinogen has~     superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and~     cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.~   "
109459|NCT01623518|"~     This is a first in man dose escalation study, to assess the safety and immunogenicity of the~     candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults~     aged 18-50. Volunteers will be enrolled and doses will be escalated according to a 3+3~     study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine,~     volunteers will be followed up to assess the side effect profile of the vaccine and to take~     blood tests. A series of immunology assays will be performed to determine how potent the~     vaccine is at inducing an immune response.~   "
109549|NCT01622322|"~     The study is prospective and double blind. In the clinic, patients undergoing inguinal~     hernia surgery that meet the criteria for inclusion into the study and agreed to participate~     in the study will be randomized into two groups. In the first group of patients will receive~     Nitrous Oxide and In the second group of patients will receive oxygen during the general~     anesthesia.~   "
109460|NCT01623505|"~     Research Aims~      The aims of this research study are:~        1. To determine which of the following three smoking cessation medications is most~          effective in achieving cessation:~             -  Nicotine Patch~             -  Nicotine Patch + gum or inhaler~             -  Varenicline (Champix;~        2. To investigate how often participants experience neuropsychiatric symptoms over the~          course of their cessation attempt and to assess whether:~             -  They occur more often when taking one medication versus another~             -  They occur more often in those with or without psychiatric illnesses.~      Hypotheses to be Tested~      The hypotheses to be tested include the following:~        1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target~          quit date will be significantly higher in smokers receiving long-term transdermal NRT~          in combination with other NRT products or those receiving varenicline compared to those~          receiving transdermal NRT alone.~        2. Some participants will experience neuropsychiatric symptoms during their cessation~          attempt, and those in the varenicline group will experience a greater incidence of~          neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or~          in combination with other NRT products. Patients with psychiatric illnesses will report~          higher levels of withdrawal symptoms than those without psychiatric illnesses.~   "
109461|NCT01623492|"~     Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center,~     observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger~     patients who meet enrollment. Patient data will be collected prospectively for three years.~     Individual physician feedback will be provided on data collected with the purpose of~     improving the management of patients - quality enhancement research initiative (QuERI)~     process.~   "
109462|NCT01623479|"~     This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at~     least 12 months for hypotrichosis of the eyelashes.~   "
109463|NCT01623466|"~     Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will~     be evaluated.~   "
109464|NCT01623453|"~     This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of~     ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II~     clinical trial.~   "
109465|NCT01623440|"~     This study aims to characterize the neurobiology of obesity in American Indians (AI) using~     functional MRIs to examine the correlation between brain response to food stimuli in AI~     women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI~     women look at images of fattening food, non-fattening food and non-food objects.~     Additionally examined is the effect of the drug naltrexone to suppress brain response to~     visual food cues and calorie intake in the women.~   "
109466|NCT01623427|"~     Postoperative pain and time taken to return to normal activities after laparoscopic surgery~     are significantly shorter. Wound infections still occur and contribute to prolonged hospital~     stays and morbidity. Typically, port incision sites are covered with a standard dressing~     (approximating strips and a gauze). Although the umbilical wound infection rate in~     laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer~     showed that the umbilical wound infection rate after single incision laparoscopic~     appendectomy in children is approximately 7%. In the same retrospective study, the~     investigators demonstrated that a simple low cost vacuum dressing can significantly reduce~     the infection rate. The aim of this prospective randomized controlled trial is to determine~     if the simple vacuum dressing is superior to a standard dressing in reducing laparoscopic~     postoperative umbilical wound infections. All patients under 17 years of age undergoing a~     laparoscopic operation in the Children's Hospital will be randomized to a standard~     postoperative dressing or a standard postoperative dressing with vacuum applied to it. The~     vacuum will be applied with a 22g needle on a 10ml syringe passed percutaneously from~     outside the dressing into the gauze and the air around the gauze is evacuated. The umbilical~     wounds will be evaluated 8-10 days postoperatively in the clinical research unit of the~     Manitoba Institute of Child Heath according to a standardized and validated wound evaluation~     tool from the Canadian Center for Disease Control. Primary outcome measure in this study is~     postoperative wound infection. A sample size calculation using the retrospective data~     demonstrated that the investigators need 275 patients in each group for the Chi-squared test~     to have an 80% chance of detecting a difference in wound infection rate of 6% at the 5%~     level of significance. Based on the annual number of laparoscopic operations in the~     Children's Hospital (around 400) the investigators anticipate completing the inclusion of~     patients within a two-year period.~   "
109467|NCT01623414|"~     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status~     of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.~   "
109468|NCT01623401|"~     This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701~     FA once daily for 10 days and will include ophthalmologic and neurologic assessments.~   "
109469|NCT01623388|"~     This research is being done to find out if significant changes in blood glucose cause bad~     outcomes in patients with diabetes.~   "
109470|NCT01623375|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absolute~     bioavailability of insulin degludec (IDeg) in healthy subjects.~   "
109471|NCT01623362|"~     The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride~     concentration in liquid dentifrices in the control of dental caries in early childhood, in~     non-fluoridated area. This study also aims to assess the effect of the consistency of liquid~     dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the~     toenails, to estimate the fluoride intake from these formulations.~   "
109472|NCT01623349|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational combination of drugs. Phase I studies also try to define the appropriate~     dose of the investigational combination to use for further studies. Investigational means~     that the combination of these drugs is still being studied and that research doctors are~     trying to find out more about it. It also means that the FDA has not approved either of~     these drugs nor the combination of being tested for use in patients, including people with~     your type of cancer.~      BKM120, BYL719 and olaparib are drugs that may stop cancer cells from growing abnormally.~     These drugs when combined in laboratory experiments with animals, have demonstrated~     anti-cancer activity. Information from these other research studies suggests that the~     following agents BKM120, BYL719 and olaparib, may help to shrink tumor cells in the types of~     cancers being studied in this research study.~      In this research study, the investigators are looking for the highest dose that can be given~     safely and also to see if the combination of BKM120 or BYL719 and olaparib is effective in~     treating your type of cancer.~   "
109473|NCT01623336|"~     The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon~     alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in~     naive patients with chronic hepatitis C.~   "
113837|NCT01566162|"~     This is a 12-week, multi-center, open-label extension study designed to evaluate the~     longer-term safety, tolerability and effectiveness of lurasidone for the treatment of~     subjects with schizophrenia.~   "
109474|NCT01623323|"~     This is an open-label, multicenter study designed to assess the safety of intranasal~     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device in subjects with chronic sinusitis with or without nasal polyps. The study consists~     of an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The~     duration of each subject's participation is approximately 13 weeks.~   "
109475|NCT01623310|"~     This is an open-label, multicenter study designed to assess the safety of intranasal~     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device in subjects with chronic sinusitis with or without nasal polyps. The study consists~     of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The~     duration of each subject's participation is approximately 53 weeks.~   "
109476|NCT01623297|"~     A study will be conducted to determine if there is any cognitive benefit in elderly patients~     having open versus minimally invasive colon cancer surgery.~   "
109477|NCT01623284|"~     The study is designed to determine whether there are clinical features that can be used as~     biomarkers to predict whether underlying Alzheimer's pathology is the cause of a speech and~     language based dementia. The primary hypothesis is that the proportion of patients who test~     positive for beta-amyloid deposition will vary across different speech and language based~     dementias.~   "
109478|NCT01623271|"~     The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with~     certain types of neuropathic pain without causing too many side effects.~   "
109479|NCT01623258|"~     The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node~     metastasis with sentinel lymph node (SLN) mapping.~      Null hypothesis: There is no difference in the rate of lymph node metastasis between~     conventional histopathological processing of lymph nodes and SLN mapping with detailed~     pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of~     colon carcinoma.~   "
109480|NCT01623245|"~     Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the~     extracellular leading to disruption of the cardiac tissue architecture. Amyloidosis in~     transthyretin (TTR) are the most common hereditary amyloidosis but remain poorly studied at~     heart. This is serious and deadly. The prevalence of TTR amyloidosis is probably~     underestimated in hypertrophic cardiomyopathy (HCM) often of unknown etiology because of the~     lack of systematic implementation of myocardial biopsy because of their side effects.~   "
109481|NCT01623232|"~     This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants~     aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion~     adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three~     reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed,~     unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three~     viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine~     will be assessed.~   "
109482|NCT01623219|"~     The investigator proposes to examine treatment for Posttraumatic Stress Disorder for~     Veterans who served in Iraq and Afghanistan provided through telemedicine which connects~     patients to doctors in different locations using the internet. In this study, Veterans will~     receive prolonged exposure therapy (PE). This treatment has been shown to be effective in~     reducing PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a~     period of up to 3 months. The first 2 sessions of each treatment will involve education,~     rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic~     event out loud and repeatedly. The purpose of this study is to determine if this treatment~     is effective when given through telehealth. To this end, the investigators propose to enroll~     up to 20 individuals who will access the investigators services through the GA telehealth~     network who has hundreds of telehealth sites across the state of Georgia. Patients will go~     to these sites to access the investigators therapists using GA telehealth equipment. The~     investigators hypothesize that PE delivered remotely through telemedicine will work to~     reduce the symptoms of PTSD.~   "
109483|NCT01623206|"~     The objective of this study is to find the maximum tolerated dose and preliminary efficacy~     of desmopressin as an haemostatic agent, when is administered to patients with colorectal~     cancer and rectal bleeding, before specific oncologic treatment with surgery and/or~     chemotherapy and/or radiotherapy.~   "
109484|NCT01623193|"~     This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia~     to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that~     all-blood cardioplegia will be associated with less blood transfusion and better cardiac~     function.~   "
109485|NCT01623180|"~     The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is~     non-inferior to a bare metal stent at one year as measured by the composite safety endpoint~     of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and~     that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at~     one year.~   "
109486|NCT01623167|"~     Background:~        -  Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune~          system starts to attack the bone marrow cells. This causes the bone marrow to stop~          making red blood cells, platelets, and white blood cells. Standard treatment for this~          disease is horse-ATG and cyclosporine, which suppress the immune system and stop it~          from attacking the bone marrow. However, this treatment does not work in all people.~          Some people still have poor blood cell counts even after treatment.~        -  Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. It~          helps the body to make more platelets. It may also cause the body to make more red and~          white blood cells. Studies have shown that eltrombopag may be useful when added to~          standard treatment for severe aplastic anemia. It may help improve poor blood cell~          counts.~      Objectives:~      - To test the safety and effectiveness of adding eltrombopag to standard immunosuppressive~     therapy for severe aplastic anemia.~      Eligibility:~      - Individuals at least 2 years of age who have severe aplastic anemia that has not yet been~     treated.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          Blood and urine samples will be collected.~        -  Participants will start treatment with horse-ATG and cyclosporine. Treatment will be~          given according to the standard of care for the disease.~        -  Cohort 1: After 14 days, participants will start taking eltrombopag. They will take~          eltrombopag for up to 6 months.~        -  Cohort 2: After 14 days, participants will start taking eltrombopag. They will take~          eltrombopag for up to 3 months.~        -  Cohort 3 and Extension Cohort: Participants will start taking eltrombopag on Day 1.~          They will take eltrombopag for up to 6 months.~        -  Participants may receive other medications to prevent infections during treatment.~        -  Treatment will be monitored with frequent blood tests. Participants will also fill out~          questionnaires about their symptoms and their quality of life.~   "
109487|NCT01623154|"~     The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring~     13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath~     test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in~     pediatric subjects.~   "
139842|NCT01224405|"~     The study includes the recruitment of patients with advanced prostate cancer resistant to~     chemical castration This is a multicenter prospective trial randomized phase III~   "
109488|NCT01623141|"~     The aim of the study is to investigate the correlation between increased bone metabolism in~     the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with~     complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The~     investigators assume that there will be a significant correlation between the investigated~     values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.~   "
109489|NCT01623128|"~     A randomized, controlled trial will be conducted during which pregnant women will be~     randomized to receive the intervention - viewing a prenatal education video about how to~     breastfeed an infant - or the sham intervention - viewing a prenatal education video about~     maternal nutrition and physical activity during pregnancy. Participants will be interviewed~     via telephone at one, three, and six months post-partum to determine how they feed their~     infants at each of these time frames.~   "
109490|NCT01623115|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 24 weeks of treatment in comparison with placebo.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effects of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
109491|NCT01623102|"~     Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor~     receptor (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin~     chemotherapy is an effective treatment measures for EGFR mutation-negative NSCLC patients,~     but the prognosis remains poor. Chemotherapy combined with targeted monoclonal antibody~     treatment may be better treatment options in these patients. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of~     tumors to grow new blood vessels and spread. It is not yet known whether cisplatin and~     gemcitabine is more effective when given alone or with bevacizumab. This randomized trial~     studies how well giving cisplatin and gemcitabine alone or in combination with Bevacizumab~     (Avastin) works in treating patients with stage IIIB/IV non-squamous NSCLC without EGFR~     mutations.~   "
109492|NCT01623089|"~     Asthma is a heterogenous disease. Different patients have different presentations, course of~     disease and response to treatment.~      The investigators would like to study our population of more severe asthma and find out~     about their profile - demographic, clinical and inflammatory.~   "
109493|NCT01623076|"~     This study seeks to determine the biologic causes of inflammation in patients with~     Neuromyelitis Optica (NMO) and related conditions. While patients will be treated according~     to decisions with their treating physician, this study will collect data and samples from~     patients prospectively to gain a better understanding of the disease. We are seeking to~     understand why some patients respond to medications, while others do not. We also seek to~     understand what happens biologically, preceding relapses. Gathering these data and samples~     will allow researchers to identify new ways of diagnosing and treating these diseases. Data~     and samples will be shared with researchers around the world to support collaborative~     efforts to treat these conditions.~   "
109494|NCT01623063|"~     To detect similarities and differences in the endometrium of fertile and infertile patients~   "
109495|NCT01623050|"~     The purpose of this study is to assess safety and performance of the SinuSys Dilation System~     for dilation of the maxillary sinus ostium.~   "
109496|NCT01623037|"~     The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for~     non-invasive fat layer reduction in flanks for Asian patient population.~   "
109497|NCT01623024|"~     Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disorders characterized~     by predominantly macrovesicular hepatic steatosis occurring in individuals in the absence of~     significant alcohol consumption. In this context it is possible to distinguish a condition~     of simple fatty liver, where the only histologic finding is the presence of steatosis, from~     a state of non-alcoholic steatohepatitis (NASH), characterized by hepatocellular~     injury/inflammation with or without fibrosis. The prevalence of NAFLD is around 20-30% in~     the general population. With a rapid increase in the risk factors for metabolic syndrome,~     NAFLD has become the most common cause of liver disease in Western countries. The clinical~     relevance of NAFLD arises from the fact that a considerable proportion of subjects (20-30%)~     develop NASH, and this condition can progress to cirrhosis in up to 15% of patients. In~     addition NAFLD, and particularly NASH, represents a cardiovascular risk factor, independent~     of other well-known conditions contributing to heart and vascular diseases.~      Lifestyle modification is the effective medical treatment recommended for NASH, while there~     is currently no pharmacologic therapy of proven benefit in these patients. Several pilot~     studies, using insulin sensitizers (thiazolidinediones or metformin), and antioxidants, like~     vitamin E, have provided inconclusive evidence that these drugs may improve clinical and~     histological features of NASH.~      In the complex and not completely understood pathogenic puzzle of NAFLD and NASH, also~     vitamin D might have an important role. Vitamin D deficiency is associated with many common~     pathological conditions frequently observed in NAFLD, like cardiovascular disease, and~     insulin resistance. A recent paper by Targher and colleagues showed low vitamin D serum~     levels in NAFLD patients, identifying an inverse relation between vitamin D levels and the~     severity of liver disease. In keeping with the above data, recent experimental evidence also~     suggested the potential ability of vitamin D, through interaction with its nuclear receptor~     (vitamin D receptor - VDR), to interfere with inflammatory response, T cell function and~     fibrogenesis. Therefore considering the link between vitamin D serum levels, severity of~     NAFLD, and risk factors for NAFLD, we speculate that vitamin D might represent a new~     therapeutic target in the management of NASH patients.~   "
109498|NCT01623011|"~     Shoulder problems causing pain and decreased function are very common. Many of these~     problems are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole~     surgery) is a common treatment for this pain. This can involve an Arthroscopic Subacromial~     Decompression (ASAD) an operation used to remove bony spurs which may be the cause of the~     pain. This procedure is widely used despite limited evidence of any effectiveness. This is a~     randomised controlled trial that will compare ASAD against an investigational shoulder~     arthroscopy (without spur removal/decompression) to indicate whether spur removal is really~     necessary and in turn, assessing the effectiveness of the ASAD procedure. Both surgical~     interventions are routine and will mirror each other except for the spur removal element.~     Both treatments will be compared against a control (non operative management with specialist~     reassessment) group to indicate whether surgery in general is effective for patients with~     subacromial pain. Patients randomised to either of the surgical options will be blinded to~     the type of surgery they have. This is a multicentre trial taking place in 10 centres in~     England and Wales. Two satellite studies will also take place. One will involve a subset of~     patients undergoing MRI scans to examine the effects of their shoulder pain on their brain~     transmissions. The other will involve collecting tissue samples from patients undergoing~     surgery.~   "
109499|NCT01622998|"~     The primary aim of this research study is to determine whether titrated, patient-directed~     transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal,~     improves long-term rates of smoking cessation in patients motivated to quit smoking when~     compared to patients using the standard transdermal NRT patch protocol. The following~     hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target~     quit date will be higher for the titrated, self-directed NRT group compared to the standard~     NRT treatment group.~   "
109500|NCT01622972|"~     The University of Nottingham have been developing new, non-invasive magnetic resonance~     imaging (MRI) techniques to image the bowel. Building on those studies the investigators~     want to study, in healthy volunteers, the effects of purging on the colon. The investigators~     plan two studies using their novel MRI techniques in healthy volunteers to demonstrate how~     doses of a preparation designed to clean the bowel alters small and large bowel water~     content and transit. The investigators will also define the changes induced in colonic~     microbiota and how these are linked to changes in transit and the structure of colonic~     contents. This experimental model is comparable to an episode of acute diarrhea, therefore~     this study will also improve their understanding of the effects of diarrhea on bowel~     physiology.~      Following from the above study, the investigators would like to extend this study on~     patients who have functional constipation and previously have not responded to conventional~     laxatives.~   "
109501|NCT01622959|"~     Pain is the most common reason that patients present to an emergency department (ED) and is~     often inadequately managed. Evidence suggests that acupuncture is effective for pain relief,~     yet it is rarely practiced in the ED.~      In 1998, a United States National Institute of Health Consensus Conference Panel reviewed~     the status of acupuncture and concluded that: There is sufficient evidence of acupuncture's~     value to expand its use into conventional medicine and to encourage further studies of its~     physiology and clinical value. Similarly, in 2002, the World Health Organisation (WHO)~     stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness~     as analgesia has been established in controlled clinical studies.~      Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the~     treatment of chronic pain is comparable to morphine and that its better safety profile and~     lack of dependence makes it the preferred method of choice for these conditions.~      There are very few clinical trials of acupuncture for acute pain to inform clinical~     practice; that's why we have the idea to do this study in our emergency department.~   "
109502|NCT01622946|"~     The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the~     suction drain following a total hip replacement~   "
109503|NCT01622933|"~     This clinical trial is to determine if the addition of a standard of care drug,~     interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune~     system and/or your cancer. The investigational vaccine will be made with genes that are~     specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3~     vaccines.~      After the vaccines, subjects will be randomized to either receive a boost of high dose IFN~     or no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days~     (Monday through Friday) every week for 4 weeks. Administration will begin approximately 30~     days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business~     days of randomization. All subsequent procedure dates for Group A will be based on the date~     of the first dose of IFNα2b.~   "
109504|NCT01622920|"~     The investigators have now established a technique to measure enamel thickness which has~     been shown to work well in-vitro. The teeth tested so far, obtained from the Dental School~     Tissue Bank, have been molars or pre-molars. In these cases, the measurement is made more~     difficult by the curvature of the tooth surface and it seems likely that flatter larger,~     incisors would give more satisfactory results. The investigators therefore wish to establish~     in-vivo whether this hypothesis is correct.~   "
109505|NCT01622907|"~     Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining~     surgical endoscopic and transcatheter techniques in a staged fashion provides superior~     clinical outcomes than isolated surgical/EP approaches in patients with persistent AF~     lasting > 1 year but > 5 years.~      The proposed procedure involves the creation of cardiac lesions with epicardially applied~     radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed~     by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.~   "
109506|NCT01622894|"~     Genetics of mendelian forms of young onset Alzheimer Disease (GMAJ project)~      Introduction : Autosomal dominant forms of Alzheimer disease (AD) are characterized by young~     age of onset. In France the prevalence was estimated at around 1000 cases. The Phenotypical~     Expression: There is diversity in phenotypical expression, associating dementia, spastic~     paraplegia, early extrapyramidal syndrome, ataxia or stroke caused by severe cerebral~     amyloid angiopathy. Diversity in neuropathological expression is demonstrated by the~     presence of cotton wool plaques, Lewy bodies with Lewy neurites and severe cerebral amyloid~     angiopathy.~      The study of mendelian forms is decisive in the physiopathological comprehension of AD and~     related diseases, since the alteration of those genes involved is sufficient to cause the~     disease. In AD, identification of these genetic causes allows the formulation of the amyloid~     hypothesis, which is the basis of current therapeutic developments concerning the Ab~     peptide. Currently three genes (APP, PSEN1, PSEN2) are identified in early onset mendelian~     forms and their mutations are involved in 80% of the 139 French families, studied since 1993~     within the framework of U614 and the National Reference Centre for Alzheimer Disease in~     young subjects (CNR-MAJ).These results are arguments in favor of the GMAJ project and have~     two main objectives:~      (i) to identify new genes in mendelian AD forms without detectable alteration on known~     genes.~      (ii) to correlate phenotypes and genotypes within families associated with known mutations~     and extend the description of the phenotypical spectrum.~      Population: Families eligible for this study are those with at least 2 individuals with AD~     criteria (clinical or neuropathological) with onset before 65 years of age. Duration of~     inclusion is 3 years. This multicentre study groups 23 clinical centres. The inclusion~     number is 50 new families per year.~      Method: Extension and description of families with unknown genetic causes, inclusion of~     novel families with autosomal dominant AD. The successive steps of the project are the~     following:~      (i) Thorough phenotypical characterization in order to document family history and~     characterize the probands and affected related subjects according to standardized protocol~     for clinical, neuropsychological, biological (biomarker determination in plasma and~     cerebrospinal fluid) and imaging data (MRI, TEMP).~      (ii) Identify known genetic causes (PSEN1/2, APP) with novel autosomal dominant families.~      (iii) Extend analysis of the pedigrees of families with unknown genetic causes.~      (iv) Identify novel genetic causes within these families which are negative for known~     mutations.~      This study uses 3 methods:~        -  pangenomic search is performed for microalterations (Copy Number Variants or CNV) by~          Comparative Genomic Hybridization (CGH) with high resolution (10 kb on average).~        -  potential targets are then validated by the study of large control populations,~          intrafamilial cosegregation and functional validation.~        -  the remaining families at the end of this stage will be characterized by means of high~          throughput sequencing of all exonic areas.~           (v) Follow up study of patients and siblings with 2 goals:~        -  evaluation of the disease course and consequences (individual, familial and social);~        -  occurrence of novel AD cases within the family.~      (vi) Neuropathological description with potential novel description of atypical AD cases.~      Results and consequences: Identification of novel genetic causes of AD are of importance in~     completing the mechanisms of the amyloidergic hypothesis. This project is useful to promote~     the guidelines on the genetic diagnosis of AD in France.~   "
109507|NCT01622881|"~     The investigators examined the efficacy of nefopam in patients undergoing kidney~     transplantation.~   "
109508|NCT01622868|"~     This randomized phase II trial studies how well whole-brain radiation therapy or~     stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients~     with breast cancer that has too many of a protein called human epidermal growth factor~     receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high~     energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a~     specialized radiation therapy that delivers a single, high dose of radiation directly to the~     tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib~     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic~     radiosurgery together with lapatinib ditosylate is an effective treatment for brain~     metastasis from breast cancer.~   "
109509|NCT01622855|"~     The purpose of this study was to evaluate whether a brief intervention in video format~     delivered in the post assault medical exam setting and including education about assault~     reactions and instruction in and modeling of successful coping strategies would reduce post~     assault drug use or abuse and PTSD symptoms as compared to standard care.~   "
109510|NCT01622842|"~     The overall objectives were to investigate if characteristic dimensions for tissue and~     vessels determined from measured bioimpedance spectra would provide the same values as~     dimensions determined from MR images of the upper arm and verify that temporal variations of~     impedances could be converted to blood pressure.~   "
109511|NCT01622829|"~     This study tries to improve patient's activity by a Prescription for Activity led by~     physiotherapists in secondary health care setting.~      Three groups are compared in regard to their increase of physical activity.~   "
109512|NCT01622816|"~     Comparing visual acuity measurements (measurements of how well you can see) using a standard~     ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart~   "
109513|NCT01622803|"~     Internal biliary drainage using stent is used for malignant hilar obstruction such as~     cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.~      Bilateral drainage is more physiologic and have more long patency than unilateral drainage.~      There are two methods of bilateral drainage: Y-stent and side by side.~      However there are no clinical data about comparing the effectiveness of these two methods.~      Therefore the investigators want to compare the clinical outcomes of two methods:~      Y-stent and side by side.~   "
109514|NCT01622790|"~     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in~     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations~     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of~     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first~     line regimen due in large part to its convenient presentation as a full treatment regimen in~     a single product, other options are needed. A fixed-dose combination of DTG/abacavir~     (ABC)/lamivudine (3TC) is one such opportunity. Part A of this study will be a single-dose,~     two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet~     in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG~     tablet that is currently being used in the Phase 3 clinical trials and the already marketed~     FDC tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this~     pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet~     formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of~     this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy~     subjects that have already participated in Part A of the study. There will be a screening~     visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14~     days after the last dose. There will be a 7 day washout between doses in each treatment~     period. The following PK parameters for DTG, ABC and 3TC will be measured: area under the~     concentration curve from time zero (pre-dose) extrapolated to infinite time~     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the~     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration~     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of~     Cmax (tmax), terminal phase half-life (t½), terminal elimination phase rate constant (λz),~     percentage of AUC obtained by extrapolation (%AUCex),apparent clearance following oral~     dosing (CL/F) and apparent terminal phase volume~   "
109515|NCT01622777|"~     To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of~     lipid peroxidation and nerve growth factor.~   "
109516|NCT01622764|"~     The research the investigators propose is a molecular imaging study of RO5323441, an~     antibody against placental growth factor (PlGF) in patients with recurrent GBM treated with~     bevacizumab, a drug against vascular endothelial growth factor (VEGF). Both VEGF and PlGF~     are molecules involved in tumor growth since they enable the development of tumor~     vasculature, thus delivery of oxygen and nutrients to the tumor. The treatment will consist~     of bevacizumab (i.v.) given every 2 weeks, until the patient has clinical benefit (no~     disease progression) or unacceptable toxicity. Meanwhile, patients will receive and~     injection of low protein-dose radiolabeled RO5323441 (89Zr-RO5323441) on day -3 and 11 of~     the first bevacizumab treatment cycle. Brain-only 89Zr-RO5323441 positron emission~     tomography (PET) will be performed at 2 hours after each injection of 89Zr-RO5323441 on day~     -3 and 11. Whole body 89Zr-RO5323441 PET will be performed on day 1 and 15, before and after~     the first treatment with bevacizumab. The main purpose of this trial is to determine how~     much of RO5323441 actually gets into the recurrent GBM lesions, since for a drug to be~     active, it has to be able to reach cancer cells. As second aims, RO5323441 accumulation in~     normal, non-tumor organs, will be assessed, as well as how bevacizumab influences RO5323441~     penetration into tumor lesions (to answer the question of combined bevacizumab + RO5323441~     treatment in GBM) or RO5323441 biodistribution in non-tumor organs.~   "
109517|NCT01622751|"~     Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing~     effect, and has been related to obstructive sleep apnea syndrome. In addition, children with~     Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of~     rapid eye movement (REM) sleep.~      Objective: To determine if the sleep stages are related to the plasma levels of adiponectin,~     resistin, and RBP4 (retinol binding protein-4), and whether these relationships are~     influenced by age, obesity and insulin resistance.~   "
109518|NCT01622725|"~     Since abdominal wall hernia repair is currently performed with the use of a mesh, side~     effects associated with the mesh are frequently reported during long term follow-up. These~     side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and~     inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing~     mesh has been developed, which provides sufficient support and strength to allow efficient~     recovery of the abdominal wall, but also disappear from your body in three years time, so~     that you no longer have any synthetic material in your body. Previous resorbing meshes also~     disappeared but over a much shorter period of time, so that the hernia was insufficiently~     healed, with recurrence as a result.~      The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh,~     made of two commonly used polymers, however it will retain 50% of its initial strength after~     six months. This in theory is enough to provide support of the collagen healing process~     during the initial wound-healing phase, but also to support the transition of initial~     collagen to functional collagen.~      The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the~     anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias~     are not part of the study).~      Therefore the patients will be divided into two groups, one group will be treated with a~     resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will~     be no difference in the medication or the surgical techniques used.~   "
109519|NCT01622712|"~     The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol~     containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient~     recovery, quick reconvalescence and adequate tissue integration with acceptable mesh~     contraction in a multicenter (Belgian) prospective trial.~      Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia~     according the current surgical practice in the participating centers will be observed during~     one year post-surgery, after which they will have a CT scan of the surgical area in the~     groin to evaluate the mesh changes regarding shrinkage and migration.~   "
109544|NCT01622387|"~     During coronary bypass surgery, veins are taken from the leg and applied to the heart and~     aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest,~     the internal mammary artery, means that the bypass lasts longer than using veins. The~     investigators recently showed that using an artery from the arm as a bypass vessel, the~     radial artery, also had less furring up than veins 5 years after surgery. Now the~     investigators would like to ask patients to come back for an angiogram 10 years following~     surgery.~   "
109545|NCT01622374|"~     To examine the pre-operative effect of music for the mind compared to some other styles of~     music in patients undergoing dental procedures.~   "
109520|NCT01622699|"~     Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns.~     Assessment of the degree of jaundice is usually done visually,and if necessary serum~     bilirubin is investigated in a blood sample. The visual assessment is subjective and can~     alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer~     is a validated measurement-tool, which provides us with an estimated serum~     bilirubin-concentration. Little is known about the effect of the actual use of a~     bilirubinometer on the quality of care. Further evidence is needed to evaluate whether~     transcutaneous bilirubin measurements improve clinical outcome (use of blood tests,~     phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore~     we aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of~     implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a~     gestational age of 32 weeks. The assessment of jaundice by use of a transcutaneous~     bilirubinometer is compared to visual assessment of jaundice~   "
109521|NCT01622686|"~     This randomized controlled trial seeks to test the effect of reformatted prescription drug~     container labels, compared to usual labels, on participants' understanding of their~     medications. The study will also assess the effect on self-efficacy and self-reported~     medication adherence. English and Spanish speaking patients are eligible, with a planned~     sample size of up to 500 adults.~   "
109522|NCT01622673|"~     This study will evaluate: (1) the effect of co-administration of single doses of calcium~     carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma~     pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected~     participants; and (2) the effect of staggered dosing of a single dose of a~     magnesium/aluminum hydroxide antacid 2 hours before and 2 hours after administration of~     raltegravir on the steady-state plasma pharmacokinetic profile of raltegravir in the same~     participants.~      The study will determine whether (1) the C12hrs of steady-state raltegravir after~     co-administration of single doses of calcium carbonate antacid is decreased to a clinically~     meaningful degree compared with C12hrs after administration of raltegravir alone; and~     whether (2) the C12hrs of steady-state raltegravir after co-administration of a single dose~     of magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree~     compared with the C12hrs after administration of raltegravir alone.~   "
109523|NCT01622660|"~     Gemcitabine and Cisplatin are standard chemotherapy drugs used to treat advanced urothelial~     cancer. There is no standard chemotherapy for patients who cannot receive Cisplatin.~     However, most patients are treated with the chemotherapy drugs Gemcitabine and Carboplatin.~      In this study, the researchers hope to learn what effects, good and/or bad, the combination~     of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously~     (through the veins) and works by killing rapidly dividing cells in the body, including~     cancer cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to~     tumors which limits the tumor's source of oxygen and nutrients.~      The combination of Gemcitabine and Pazopanib is being tested in research studies such as~     this one. As of August 2011, more than 18 patients with various types of cancer have~     received treatment with Gemcitabine and Pazopanib. The main goal of this clinical research~     study is to learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth~     of urothelial cancer. The safety of this drug will also be studied. The physical state,~     changes in the size of the tumor, and laboratory findings will help us decide if the~     combination of Gemcitabine and Pazopanib is safe and effective.~   "
109524|NCT01622647|"~     The proposed study intends to investigate several aspects of the respiratory effects of~     intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery.~     The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is~     expected to be elevated as a result of intravenous sedation and postural factors. Further,~     the study will investigate how application of Nasal Continuous Positive Airway Pressure~     (N-CPAP) may impact PaCO2.~   "
109525|NCT01622634|"~     The objective of this study is to determine the combined effects of a high-protein diet and~     high-intensity training on metabolic syndrome risk factors in women aged 30-65.~   "
109526|NCT01622621|"~     This randomized phase II trial is for medically inoperable early stage non-small cell lung~     cancer (NSCLC) patients. It is designed to compare the number of patients who are disease~     free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical~     intervention arms. SBRT is less invasive and felt to be equally effective to surgery for~     early stage NSCLC. Surgery is currently the standard of care for these patients. The~     hypothesis of this study is that SBRT is at least as good as surgery for disease free~     survival at 2 years.~   "
109527|NCT01622608|"~     The purpose of this study is to determine whether implementation of a web-based educational~     intervention using a vaccine information kiosk placed in primary care practice waiting~     rooms can reach a large number of parents and have a measurable impact on adolescent~     vaccination rates, specifically for Tdap, HPV, meningococcal, and influenza vaccines.~   "
109528|NCT01622595|"~     OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS~   "
109529|NCT01622582|"~     Engraftment Syndrome after Autologous Stem Cell Transplant: Retrospective Review in Patients~     with Multiple Myeloma~   "
109530|NCT01622569|"~     The primary objective of this study is to compare the efficacy of intranasal administration~     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose~     device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints~     will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of~     Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM~     diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal~     cavities) over the 16 weeks of the double-blind treatment phase as determined by the~     Lildholdt scale score measured by nasoendoscopy.~   "
109531|NCT01622556|"~     This is a phase II study to assess the day 180 event free and overall survival after~     administration of a specified combination of fludarabine, busulfan, Total Body Irradiation~     (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant~     in a single institution setting in patients with hematologic malignancies for whom~     allogeneic transplantation is indicated.~   "
109532|NCT01622543|"~     The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/~     bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.~   "
109533|NCT01622530|"~     Amputees often choose not to wear prostheses due to marginal performance or may settle for a~     prosthesis that offers only cosmetic improvement, but lacks function. A simulation tool~     consisting of a robotics-based human body model (RHBM) to predict functional motions, and~     integrated modules for aid in prescription, training, comparative study, and determination~     of design parameters of upper extremity prostheses will be developed.~      The main objective of collecting and analyzing human movement during several common tasks is~     to optimize and validate the robotics based human model. The range of motion data of~     subjects performing activities of daily living such as opening a door, turning a wheel,~     grooming, eating, bilateral lifting, as well as recreational and sport activities such as~     swinging a baseball bat, and golf club will be analyzed. This motion analysis data will also~     be used to compare data between four groups: a control group (n=10), a braced group~     simulating prosthesis use (n=10), a group wearing a transradial prosthesis (n=10) and a~     group wearing a transhumeral prosthesis (n =10).~   "
109534|NCT01622517|"~     The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project~     (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to~     benefit from endovascular therapy.~      The project has two main parts. During the first part, the investigators propose to develop~     a fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will~     generate brain maps of the ischemic core and penumbra. There will be no patient enrollment~     in part one of this project.~      During the second part, the investigators aim to demonstrate that physicians in the~     emergency setting, with the aid of a fully automated CTP analysis program (RAPID), can~     accurately predict response to recanalization in stroke patients undergoing~     revascularization. To achieve this aim the investigators will conduct a prospective cohort~     study of 240 consecutive stroke patients who will undergo a CTP scan prior to endovascular~     therapy. The study will be conducted at four sites (Stanford University, St Luke's Hospital,~     University of Pittsburgh Medical Center, and Emory University/Grady Hospital). Patients will~     have an early follow-up MRI scan within 12+/-6 hours to assess reperfusion and a late~     follow-up MRI scan at day 5 to determine the final infarct.~   "
109535|NCT01622504|"~     This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie~     nasal spray (Test Product) and as a solution for injection (Comparator Product) administered~     intranasally using a mucosal atomization device (MAD).~   "
109536|NCT01622491|"~     Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted~     pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials.~     Observational studies have found that these vaccines were effective in preventing laboratory~     confirmed influenza infections. However, it remains unclear whether vaccination during the~     pandemic was associated with reductions in more clinically meaningful outcomes, such as~     hospitalizations, severe illness, complications, and death.~      The investigators propose to evaluate the effectiveness of the GSK adjuvanted and~     non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe~     illness (defined as illness necessitating admission to intensive care or associated with~     major complications) due to influenza or pneumonia by means of a case-control study using~     data from Manitoba Health (MH) administrative databases and the database of the Cadham~     Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed~     influenza or pneumonia. A secondary outcome will be hospitalization with influenza or~     pneumonia. The investigators will also assess the effectiveness of the above vaccines for~     different age groups and among high-risk populations, e.g., immunocompromised individuals.~   "
109537|NCT01622478|"~     Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently~     debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic~     drainage thus causing lower SLN identification rate and higher false negative rate. Further,~     the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can~     accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to~     determine the identification rate, the false-negative rate, and the accuracy of SLNB after~     NAC for node positive breast cancer.~   "
109538|NCT01622465|"~     The aim of this study is to evaluate the effects of an exercise program with a cycle~     ergometer in functional outcome and related-health quality of life (RHQL) in elderly~     patients with total hip arthroplasty.~   "
109539|NCT01622452|"~     Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It~     is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first~     post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the~     figure remains stable over the long-term.~      The investigators will recruit 50 patients undergoing elective valve surgery and each~     patient will receive complete evaluation a) preoperative, one week before surgery; b) early~     postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.~      The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance~     Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to~     evaluate POCD.~   "
109540|NCT01622439|"~     Patients with previously untreated diffuse large B-cell lymphoma will receive standard~     treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison)~     for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times~     daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment~     is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD~     20-expression.~      Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels~     are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.~   "
109541|NCT01622426|"~     The investigators aim to assess the tolerance to a new commercially available Aaf in~     children affected by IgE- or non-IgE-mediated CMA.~   "
109542|NCT01622413|"~     This study compares an endoscopic transforaminal surgical technique for the treatment of a~     herniated disc to the standard microsurgical procedure. Clinical parameters as well as~     health economy will be assessed.~      The study hypothesis is that the endoscopic approach is equivalent or superior to~     microdiscectomy.~   "
109543|NCT01622400|"~     A dedicated therapeutic education program is an essential tool in the management of~     hypertension as well as in the control of other cardiovascular risk factors. The purpose of~     this study is therefore to evaluate the effect of such a therapeutic education program in~     general practice patients at high cardiovascular risk.~   "
109550|NCT01622309|"~     Cardiovascular diseases (CVD) prevail as the main cause of death in developed and developing~     countries and are among the most frequent causes of disabilities in Brazil and in the world.~      Economic alternatives have been studied to assist in reducing cardiovascular risk factors.~     Within this context, the Solanum menogena, whose fruit known as eggplant is widely consumed~     in Brazil, is being used in alternative medicine with the purpose to reduce the~     concentrations of cholesterol, glucose and promote loss of body weight.~      Aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat~     content. In addition, it is popularly known for its functional properties, aiding in~     reducing the risk of coronary diseases. The purplish coloring of the eggplant peel is~     attributed to the large amount of flavonoids, which have antioxidant properties and~     contribute to the flavor of eggplant.~      The investigators hypothesis is that the eggplant flour associated with a restricted calorie~     diet has effect in reduction in waist circumference, reduction of body fat and increasing~     HDL-cholesterol; this way, contributing to the reduction of cardiovascular risk factors~      All participants will be informed about the research and they will have to sign a consent~     form. The volunteers will be divided into two groups: one group will receive a~     restricted-calorie diet and supplementation with eggplant flour; and the other will receive~     a diet plus a placebo for 120 days, being both groups evaluated monthly. In each~     consultation, evaluation of weight, body composition, fulfillment of the diet and blood~     pressure measurement will be performed. In addition, blood will also be collected in order~     to determine glucose, insulin, total cholesterol, LDL, HDL, triglycerides, oxidized anti-LDL~     antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and~     copper). The results will be analyzed by statistical program.~      The investigators expect that with the results obtained, the eggplant flour can be used as~     an ally in the prevention of cardiovascular diseases.~   "
109551|NCT01622296|"~     The purpose of this study is to determine the effectiveness of buffered local anesthesia~     injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine~     with sodium bicarbonate may reduce the pain of injection for both adults and children. In~     this study, the investigators will compare two local anesthetic preparations, a buffered~     anesthetic and the conventionally available anesthetic, for pain upon injection.~      Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection~     compared to the acidic alternative used in most dental offices. This can be demonstrated by~     comparing two local anesthetic preparations, a buffered anesthetic and the conventionally~     available anesthetic, for pain upon injection.~   "
109552|NCT01622283|"~     This study will be a single center, open-label, randomized, single dose, in the fasted~     condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and~     tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese~     healthy male subjects.~      Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg~     and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be~     collected and safety assessments will be performed following each dose.~      The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in~     plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in~     Japanese healthy male subjects.~   "
109553|NCT01622270|"~     The objective of this study is to investigate the changes in crohn on resting energy~     expenditure.~   "
109554|NCT01622257|"~     The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin~     or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding~     clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid~     profile.~   "
109555|NCT01622244|"~     The study will assess the effectiveness and cost-effectiveness of providing brief, intensive~     case management for frequent users of hospital Emergency Departments who have mental health~     and/or addictions problems. The goals of the intervention are to support patients'~     transition to community-based health and social services and supports - including primary~     and urgent psychiatric care, peer support and other community services and supports - so as~     to improve patient wellbeing and reduce avoidable ED visits and hospitalizations.~   "
109556|NCT01622231|"~     Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese~     paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated.~     And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray~     over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with~     perennial allergic rhinitis will also be evaluated.~   "
109557|NCT01622218|"~     The purpose of our study to quantitatively examine the stress levels prior to surgery and~     the use of analgesics post surgery in both children and their parents following a~     preoperative intervention with a medical clown compared to children that were not exposed to~     this intervention.~   "
109558|NCT01622205|"~     Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for~     more patient days than any other single condition in Swedish health care. The Swedish~     guidelines for stroke treatment, issued by the national board for health and welfare,~     recommend early supported discharge for people with mild to moderate stroke. This is based~     on studies in which mean hospitalization was 18 days. The average length of stay in Sweden~     is 12 days. Policy makers would, however, like to shorten length of stay even further, and~     many patients are anxious to get home. Where and how to get support at home after discharge~     varies.~      This study is a randomized controlled trial in which half of the subjects are randomly~     allocated to very early supported discharge and the other half receives usual treatment. The~     investigators believe that patients discharged very early with support will experience less~     anxiety compared with controls. The investigators believe that early supported discharge is~     safe and that there is no difference between groups in bodily function. In order to test~     differences between the groups, the study requires approximately 110 subjects.~      Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be~     recruited to the study. The intervention is having a team from the stroke unit visiting the~     patient's home and train him/her according to the individualized goals. The controls are~     discharged according to routine with support from primary care if needed. Assessments are~     made by therapists who are not involved in the training upon returning home, at 1 month, 3~     to 12 months. The assessments include anxiety, motor activity, gait and balance, and ADL.~     Interviews will be done to highlight the subject's own experience.~      It is important to evaluate new methods and organizational changes prior to their~     implementation in health care. The investigators hope to show that very early supported~     discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is~     possible to introduce a method that simultaneously improves patient outcome and increases~     availability of hospital beds.~   "
109559|NCT01622192|"~     The aim of the study is to determine the best method for measuring the extent and severity~     of the gum disease by comparing the repeatability of probing depths achieved by a manual~     probe when compared to an automated probe.~      Hypothesis~      The null hypothesis to be tested includes~        -  The automated probe does not improve the reproducibility of periodontal probing when~          compared to manual probing recordings~        -  The automated probe shows no advantage when comparing the reproducibility of~             -  Moderate sites~             -  Deep sites~             -  Single vs. multirooted teeth~             -  Different sextants~             -  Different surfaces of teeth Buccal vs. palatal/lingual Mesial vs. mid vs. distal~   "
109560|NCT01622179|"~     The purpose of this study is to estimate the effective of two suture methods in the~     treatment of Achilles rupture.~   "
139873|NCT01223989|"~     The purpose of this study is to determine the utility of an hypocaloric diet with or without~     bread in patients with overweight and obesity~   "
109561|NCT01622166|"~     Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic~     art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of~     schizophrenia compared to a group of patients receiving treatment as usual.~      *Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission~     compared to TAU.~      *Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing~     function, self-efficacy and neuroleptic dosage compared to TAU.~   "
109562|NCT01622153|"~     1. The investigator hypothesize that the Laser pulpotomy will provide adequate and~          comparable success clinically in primary molars.~        2. The investigators hypothesize that the Laser pulpotomy will provide adequate and~          comparable success radiographically in primary molars.~   "
109563|NCT01622140|"~     This is a prospective cohort study of persons tested for latent tuberculosis infection at~     either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to~     tuberculosis disease. The study will assess the relative performance and cost of three~     diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB~     Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the~     cohort. This study will also determine the risk and rate of progression to active TB~     disease, overall and by the results of the three tests.~   "
109564|NCT01622127|"~     A novel concept of self-gripping mesh has been developed to achieve secure and long-term~     posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament~     polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which~     provide self-gripping properties during the first few months after implantation. The~     self-fixation of the mesh to the underlying tissues is instantly achieved at application,~     limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and~     damage cutaneous nerves), and providing a near tension-¬free repair.~      Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and~     painless treatment of incisional hernias and provides secure and efficient fixation mesh. On~     this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional~     hernia defect treatment. In order to assess the clinical outcomes following the use of~     ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has~     been initiated.~   "
109565|NCT01622114|"~     Achievement and maintenance of weight loss in obese individuals has proven difficult. Many~     hypotheses have suggested potential biological mechanisms to explain why weight loss~     attempts often fail, and the surrounding obesogenic environment also seems an obvious~     candidate. Among the biological factors proposed is gender, and weight loss trials have~     frequently shown that females are less successful than males at losing weight and at~     maintaining weight loss.~      Women's weight is influenced by the menstrual cycle, in which changes in hormonal levels and~     interactions work to modulate fertility. These hormones control the menstrual cycle and~     coordinate the required changes in energy intake, expenditure, and storage, whilst preparing~     the body for pregnancy every month. As reproduction is a primary biological function, these~     hormones may be such strong mediators of eating behavior that they influence the outcome of~     a weight loss attempt. The menstrual cycle should therefore be taken into consideration as a~     factor in the physiology of energy balance in premenopausal women.~      The cycle can be divided into three phases: menstruation or early follicular phase (days~     1-5), late follicular phase that lasts until ovulation (~days 6-14, and the luteal phase~     (days 15-28).~      Studies have shown that in the luteal phase of the menstrual cycle, women's energy intake~     and energy expenditure are increased and women experience more frequent cravings for foods,~     particularly those high in carbohydrate and fat, than during the follicular phase. A trend~     towards reduced carbohydrate utilization and increased fat oxidation in the luteal phase has~     also been reported, together with prolonged time to exhaustion when exercising at submaximal~     intensities. This suggests that the potential of the underlying physiology related to each~     phase of the menstrual cycle may be worth considering as an element in strategies to~     optimize weight loss.~      In 2010 the investigators carried out a 90-day randomized, controlled pilot study in order~     to gain feedback on and assess acceptance of the meal and exercise plans being used and to~     observe if less control visits than planed in the main study were sufficient to achieve good~     compliance. Twenty eight were sreened and 24 were included. Subjects were randomized to~     either program A (given meal and exercise plans in relation to phases of their menstrual~     cycles) or Program B (a reduced calorie diet, calorie-matched to program A). The pilot study~     showed that Group A (The Menstralean group) tended to have a greater average weight loss at~     60 days (-5.29 vs -3.57 kg, p = 0.06) and 90 days (-4.22 vs -2.75 kgs, p = 0.2) compared to~     the control groups. There was a dropout rate of 27%. This was primarily due to an inadequate~     number of control visits and contact with the subjects. Thus the Menstralean program seems~     to have the potential to enhance weight loss in overweight and obese women. However, the~     main study has to be carried out with more subjects in each group in a longer duration and~     with more support and contact with the subjects.~      The aim of the present trial is to examine the impact of the menstrual cycle on weight loss~     attempts in healthy overweight (BMI > 27 kg/m2) premenopausal women (18-40 years) randomized~     to two different weight management programs for a period of 6 months.~   "
109566|NCT01622101|"~     Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of~     a combination of yerba mate, guarana, caffeine and damiana. The combination has previously~     been shown to decrease gastric emptying and its weight controlling effects may be related to~     increased satiety and thermogenesis.~      Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic~     factors and subjective appetite sensations.~      Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized,~     double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg~     xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The~     thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate~     (HR) and appetite ratings were assessed every half hour.~   "
109567|NCT01622088|"~     The purpose of the study is to collect long-term safety data from subjects with Amyotrophic~     Lateral Sclerosis (ALS) exposed to dexpramipexole.~   "
109568|NCT01622075|"~     The purpose of this study is to evaluate the efficacy and safety of successful~     interventional therapy and unblocked blood vessel maintaining in the treatment of coronary~     in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface~     area) versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary~     artery stenosis is 2.5mm-4.0mm and the length ≤30mm.~   "
109569|NCT01622062|"~     The purpose of this study is to assess the 4-site one-week post-exposure prophylaxis (PEP)~     regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.~      Primary objective:~        -  To demonstrate that PEP using the new one-week, 4-site (4-4-4-0-0) intradermal PEP~          regimen (with and without rabies immunoglobulin), is non-inferior to PEP using the~          updated TRC (2-2-2-0-2) ID PEP regimen with rabies immunoglobulin in terms of~          seroprotection rate at Day 14.~      Secondary objectives:~        -  To describe the immune response in each group at Day 0, Day 14 and Day 90.~        -  To describe rabies virus-neutralizing antibody persistence during the 5 years after~          completion of PEP in each group.~        -  To describe the immune response induced by a single-visit 4-site intradermal (ID)~          booster vaccination in each group at Year 5.~        -  To describe the safety profile of each treatment group after the primary and booster~          vaccinations.~   "
109570|NCT01622049|"~     Patients undergo a detailed ultrasound examination to rule out the presence of congenital~     anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS~     will be considered candidates for the trial. Patients will be counseled about the risks and~     benefits of all treatment options and will be free to choose any treatment option. They will~     then be asked to sign an informed consent. The procedure will be performed under local~     anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be~     introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be~     located endoscopically and will be lasered with YAG laser energy. An accessory port may be~     required in some cases. The procedure will be monitored both endoscopically and~     sonographically. The presence of fetal heart activity will be noted often during the~     procedure. An amniodrainage of the larger sac may be performed at the time of the procedure.~     The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on~     the first post operative day. Patients will undergo a weekly ultrasound examination for four~     weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will~     include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders,~     absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein,~     ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their~     corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive~     care unit will be followed through their discharge. Evidence of neurological or cardiac~     morbidity will be sought in each twin. If either of these complications is suspected,~     evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be~     followed up for neonatal, infant and childhood morbidity or mortality. It is requested that~     all placentas be delivered fresh to Tampa General Hospital in an icebox container for~     assessment. Placentas will be discarded after analysis.~   "
109673|NCT01620697|"~     While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value~     as independent parameter in predicting postoperative complications after colorectal~     resection remains poorly investigated.~      The investigators want to test the value of perirenal fat as surrogate of visceral obesity~     as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body~     mass index (BMI) and Waist- Hip ratio (WHR).~   "
109971|NCT01616823|"~     In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also~     receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the~     length of time of rupture of membranes.~   "
109571|NCT01622036|"~     It is estimated that up to 30% of cancer patients die because of the effects of~     malnutrition, caused by a discrepancy between nutritional needs and intake (or utilization)~     of energy and essential nutrients. Malnutrition and its severe complication, cancer~     cachexia, are negative prognostic factors in neoplastic patients, inducing Decreased~     response and tolerance to antineoplastic treatments, decline in the functional status,~     reduced quality of life and reduced survival. Prevalence data on malnutrition in italian~     oncology patients are lacking and the available literature data on weight loss and~     malnutrition in oncology refer to patients in different phases of disease and therapy. Most~     importantly , strategies for prevention of malnutrition and cachexia in oncology are still~     largely disregarded and scarcely implemented.~      The main objective of this project is to assess the prevalence of malnutrition in patients~     undergoing first medical oncology visit in Italy. Secondary objective is to increase~     awareness of metabolic and nutritional issues among medical oncologists, thus favoring the~     inclusion of metabolic-nutritional screening and monitoring in medical oncology protocols.~     This would in turn contribute to reduce the negative consequences of malnutrition- and~     cachexia-related complications.~   "
109572|NCT01622023|"~     The aim of the present study is to prospectively evaluate whether performing an~     intra-uterine insemination 24 hours after the spontaneous LH peak may result in~     significantly higher ongoing pregnancy rates compared to 48 hours.~   "
109573|NCT01622010|"~     The purpose of this research is to determine if there is a greater behaviour change in self~     management of heart failure following reinforced multimedia education focusing on physical~     activity as compared to standard care. It is the investigators belief that participants who~     receive DVD education in addition to usual care will show improved self management in~     comparison to receiving usual care alone. The investigators anticipate fewer hospital~     admissions due to improved self care management.~   "
109574|NCT01621997|"~     To examine whether retraining via operation inspection or verbal education can reduce the~     risk for peritonitis in PD patients.~   "
109575|NCT01621984|"~     The purpose of this current prospective study is to assess the effects of a Therapeutic~     Riding exercise program conducted in patients suffering from neuromuscular disease. The~     exercise intervention aims at improving gross motor function, gross motor performance,~     balance, spasticity, posture and quality of life. Patients were randomized according to age,~     sex, mental ability and gross motor function. Furthermore, patients will be subdivided into~     categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve~     or muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40~     minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the~     Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the~     Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control,~     the Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results~     will be collected and evaluated using the statistical programme SPSS.~   "
109576|NCT01621971|"~     Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary~     arterial pressure due to severe mitral valve regurgitation without compromising systemic~     hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery~     pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral~     regurgitation patients undergoing mitral valve surgery.~   "
109577|NCT01621958|"~     Slip-related falls often cause injury; these often have catastrophic consequences, even~     among the healthiest older persons. Establishing a retainable preventive training regimen~     against slip-related falls would, without doubt, have major public health implications. In~     this study, investigators will demonstrate that older adults can significantly reduce their~     near-term risk of backward balance loss and falls through motor training with multiple~     protected slip exposure, and such adaptive improvements from such prophylactic training~     regimen can be retained over the course of a year.~   "
109578|NCT01621945|"~     The main objective of the study is to estimate the proportion of children, born between the~     06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac,~     with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>=~     4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.~   "
109579|NCT01621932|"~     Randomized prospective study comparing the anterior capsule repair vs capsulectomy with~     regards to post-operative pain and range of motion outcomes in elective primary unilateral~     direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded~     for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by~     goniometer measurements and lateral hip radiographs in maximum flexion.~      The purpose of the study is to compare post-operative pain control and hip range of motion~     between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during~     direct anterior total hip arthroplasty.~   "
109580|NCT01621919|"~     S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and~     Western GC patients. Recently, some case and small-sized studies have been reported on~     lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct~     secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected~     to be high in patients who developed LDO than in patients without LDO. We investigate the~     concentration of S-1 and its metabolites in tear and plasma and find out its correlation~     with side effects such as LDO. These results will also help us identify patients who are at~     high risk of developing S-1-associated side effects.~   "
109595|NCT01621724|"~     WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid~     leukaemia.~      Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells~     by transferring a gene into the T cells, which allows them to recognize fragments of a~     protein called WT1. This protein is present on the surface of leukaemia cells at very high~     levels. The gene transferred to the T cells enables them to make a new T cell receptor~     (TCR), which will allow them to attack leukaemia cells with high levels of WT1 on their~     surface.~      Using this form of gene therapy the investigators can convert some of the patient's immune~     system's own T cells into T cells that the investigators hope will be much more effective at~     recognizing and killing leukaemia cells.~   "
109596|NCT01621711|"~     This component of a larger Center of Research Excellence Grant improves treatment for drug~     abuse by developing effective linkages between specialty drug treatment and primary health~     care.~   "
109581|NCT01621906|"~     The purpose of this study is to compare two different imaging methods to examine the~     response of brain metastases to WBRT. These two imaging methods will take pictures of the~     brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance~     Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive~     substances also called as radioactive markers to see cancer cells. We plan to use [18F]FLT~     as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical~     procedure. It is in the testing stage of development unlike FDG-PET which is used more~     commonly used. Therefore, this is considered a research study. This will help us evaluate~     whether this scan will be safe and better used in the future to evaluate tumors. The amount~     of radiation to the body is small. The radiation from the radiotracer drug will be gone from~     the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we~     also plan to use MRI imaging of the brain. We expect that [18F]FLT PET is better when~     compared to MRI and will give us more information about the brain metastases after WBRT.~   "
109582|NCT01621893|"~     Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty~     procedure including changes in pain, function, and overall health.~   "
109583|NCT01621880|"~     Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This~     randomized trial aims to investigate whether bevacizumab may alleviate radiation-induced~     brain necrosis in patients with nasopharyngeal carcinoma. The effect will be compared with~     outcomes in patients receiving steroid therapy.~   "
109584|NCT01621867|"~     Cystic fibrosis is a genetic condition where epithelial cells, including from the~     respiratory tract, have an abnormal function of a surface protein, the cystic fibrosis~     transmembrane conductance regulator (CFTR) protein resulting from abnormal gene expression.~     The trial will assess the clinical efficacy, safety & tolerability and gene expression~     following repeated nebulised doses of a gene product coding for a normal CFTR protein, with~     the primary outcome of the trial assessing lung function.~   "
109585|NCT01621854|"~     This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent~     in patients with advanced solid tumours who have failed to respond to or who have relapsed~     after treatment with standard therapy. NUC-1031 is a ProTide of gemcitabine, a drug that has~     been used widely and effectively against cancers for many years. Both NUC-1031 and~     gemcitabine work by preventing cancer cells from dividing by attacking their DNA~     (deoxyribonucleic acid). Non clinical studies have shown that NUC-1031 is more effective~     than gemcitabine because it is able to reach cancer cells by passive diffusion, is less~     easily degraded by the cancer cell, and delivers the monophosphate form of the active agent.~     The first part of the study is to determine recommended phase 2 dose by dose escalation and~     the second part is to explore preliminary anti-tumour activity.~   "
109586|NCT01621841|"~     Glaucoma is a neurodegenerative disease representing the second cause of blindness~     worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one~     as it is observed for normal tension glaucoma. Some studies have reported lesions of the~     optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by~     increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy~     could help us to analyze visual pathways and to determine the association with~     neurodegenerative diseases as Alzheimer.~      The investigators propose to compare volume and structure of the visual pathways between~     glaucoma patients and healthy subjects matched on age and sex.~      Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells,~     visual field deterioration and optic nerve cupping. Some studies have suggested that all the~     visual pathways could be damaged in glaucoma. Recently, a German study proved a significant~     reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T.~     Some authors have also suggested that glaucoma could share similarities with the other~     neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual~     pathways with a high level of spatial resolution.Fractional anisotropy is a tag of~     microstructure.~   "
109587|NCT01621828|"~     The aim of this study is to investigate a possible reduction in pre-operative anxiety in~     patients undergoing major elective surgery, by providing multimedia information regarding~     the patient pathway to and from the Operating Theatre.~   "
109588|NCT01621815|"~     As the use of video games (VG) is rapidly increasing, many studies have tries to understand~     the effects of VG on the children and adolescents playing them.~      Most of the research was directed towards negative effects (especially violence, attention~     and school performance), producing mixed results.~      Recently, more studies had focused their attention on the opposite angle: The influence of~     the player's mental and behavioral parameters, influencing his VG playing patterns. The~     focus of most of these researches was time of playing, addictive patterns and exposure to~     violence.~      The current study will try to characterize the variance of VG playing pattern among~     adolescents diagnosed with psychiatric disorders, in order to better under the rich~     interaction between a player and his VG, and to understand whether VG playing patterns holds~     diagnostical clues for the child's diagnosis and his inner world.~   "
109589|NCT01621802|"~     The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)~     in the US by generating immunogenicity and safety data in contrast to the US standard of~     care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six~     years of age.~   "
109590|NCT01621789|"~     Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule~     during cataract phacoemulsification.~   "
109591|NCT01621776|"~     This study aims to compare the post-meal blood glucose values of two drugs in a real-world‟~     setting.~   "
109592|NCT01621763|"~     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's~     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation~     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to~     assess the bioequivalence.~   "
109593|NCT01621750|"~     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's~     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation~     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fasting conditions~     and to assess the bioequivalence.~   "
109594|NCT01621737|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms~     despite being on adequate treatment with antipsychotic medication.~   "
109597|NCT01621698|"~     This project involves looking at the timing of providing pain relief for patients who are~     having lung surgery via the use of a small camera inserted into the chest with a scope~     (Video assisted thorascopy). This procedure can be the source of intense pain both~     immediately after the procedure and in the longer term leading to chronic pain problems.~      Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal~     column, where the pain nerve fibres are located, is a well recognized method of providing~     pain relief for these procedures. It is currently unclear as to the best timings for~     providing this type of pain relief with some centres placing the local anaesthetic at the~     start of the procedure and some at the end. Placing a high volume of local anaesthetic into~     this area at the start of the case may provide better short and long term pain relief than~     placing it at the end of the procedure. The investigators hope to show a difference between~     the two timings to allow for better pain relief for these procedures. This would be a~     feasibility study that would lead onto a multicentre trial to eventually create a best~     practice protocol for pain relief for lung resection via this surgical method.~   "
109598|NCT01621685|"~     In 2004, the investigators initiated a human Capsaicin inhalation experiment under an~     Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject~     safety procedures instituted and approved by the Institutional Review Board (IRB). As part~     of the study protocol, inhaled Capsaicin solutions were analyzed using high performance~     liquid chromatography (HPLC). The investigation employed safety procedures while conducting~     the human inhalation investigations. In addition, during our investigations we observed~     discrepancies between the predicted Capsaicin concentrations mixed by a registered~     pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of~     Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and~     protected against ultraviolet light were examined.~   "
109599|NCT01621672|"~     The purpose of this study is to determine in a phase II trial, whether further maintenance~     therapy with Revlimid can extend the duration of progression-free survival and the duration~     of complete or near complete response compared to no further therapy beyond the TT3~     protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years~     with VTD (2003-33) or VRD (2006-66).~   "
109600|NCT01621659|"~     People with breast cancer and lymphoma often experience many short and long-term side~     effects as a result of both the cancer and the necessary treatments.~      Receiving extra assessments and care from teams of multiple health professionals has been~     shown to be helpful for people with other health problems, such as heart disease. These~     'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise~     therapists, counselors, and other specialists. Currently, the investigators do not know if~     receiving extra assessments from a multidisciplinary team is helpful for people receiving~     cancer treatment.~      In this study, the investigators hope to learn the effect of extra assessments and early~     interventions from teams of health care professionals in people diagnosed with cancer,~     during and after the treatment period.~      After initial assessments, participants will be randomized to multidisciplinary team~     intervention or usual care.~   "
109601|NCT01621646|"~     Cognitive impairment is also a major risk factor for development of dementia later in life.~     Findings from our studies suggest that the carotenoids, lutein and zeaxanthin may be~     important in cognitive function in the elderly. The investigators have previously reported~     eggs to be a highly bioavailable source of lutein and zeaxanthin. Our study evaluates~     long-term egg intervention as a treatment strategy for age-related cognitive impairment~     which could possibly prevent the onset of dementia. The investigators have also shown that~     lutein supplementation significantly improved verbal fluency scores in healthy older women.~     Our studies have shown that egg interventions can significantly increase serum lutein~     concentrations in older adults. Based on the sum of our findings, the next logical step will~     be to investigate the ability of lutein and zeaxanthin contained in eggs to influence~     cognitive function in older adults. The investigators hypothesize that there will be a~     significant increase in cognitive function measures in older adults provided with meals~     containing 2 egg/day at the end of 6 months, while no significant improvements will be~     observed in older adults given daily meals containing egg substitute.~      The proposed study is designed as a randomized, placebo controlled trial that tests the~     effects of 6 month supplementation with 2 eggs/day on cognitive function in older adults.~     Secondary analyses will determine whether baseline MP density predicts relative~     effectiveness of the intervention on cognitive function. Secondary outcomes include plasma~     biomarkers of oxidative stress and inflammation.~   "
109602|NCT01621633|"~     This is a study to characterize the pharmacokinetics as well as safety and tolerability of a~     single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment~     compared to matched healthy subjects~   "
109603|NCT01621620|"~     objectives~        1. To study the sympatho-vagal balance effect on different limbs of pain perception.~        2. To determine whether it is the hypertension by itself or the baroreflex activation due~          to blood pressure rise that is responsible for the analgesic effect of acute~          hypertension.~      study questions~      The study questions are derived from the study objectives:~        1. Does sympatho-vagal balance influence pain perception?~        2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?~        3. Does sympatho-vagal balance influence temporal summation?~        4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex~          activation?~   "
109611|NCT01621516|"~     Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a~     tendency to develop in the long-term diabetes. Patients who have received extra pancreatic~     tissue with their liver and small bowel transplantation have not yet developed insulin~     resistance or diabetes mellitus. We would like to investigate to which level insulin~     secretory capacity the extra pancreas together with the native pancreas has in these~     transplant patients using the hyperglycemic clamp. These data will be compared with the data~     obtained from healthy controls.~   "
109612|NCT01621503|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary~     objective is to evaluate any adverse events found during the clinical study.~   "
109613|NCT01621490|"~     The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab~     in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood~     and tumor tissues of subjects with advanced melanoma (unresectable or advanced)~   "
109604|NCT01621607|"~     Background:~      - The risk for becoming addicted to drugs varies among individual, even those using similar~     drugs in a similar way. It is not known why some people become addicted and others do not.~     Studies suggest that some genes may increase the risk of addiction. Negative life~     experiences may also affect the risk of addiction. Researchers want to test smokers and~     nonsmokers to study genetic and brain function traits that may lead to drug addiction.~      Objectives:~      - To understand brain function in people who may be at a higher risk of drug addiction.~      Eligibility:~        -  Healthy volunteers between 18 and 55 years of age.~        -  Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be~          eligible.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will be~          tested for drug and alcohol use. A blood sample will be collected.~        -  The study will involve one visit. Participants will have a magnetic resonance imaging~          (MRI) scan.~        -  At the visit, participants will answer questions about their health and drug use~          habits. They will then be trained on the tasks they will do during the MRI scan. After~          the training, they will have the scan and perform the tasks. The scan and tasks will~          look at brain function related to rewards and impulsiveness.~        -  Other computer tests will be given after the scan. These tests will measure learning,~          memory, and impulsiveness.~   "
109605|NCT01621594|"~     Title: Evaluating New Radiation Techniques for Cardiovascular Imaging~      Background:~      - Imaging studies such as computed tomography (CT) scans involve the use of radiation to~     create the pictures. Heart and blood vessel CT scans can cause high radiation exposure.~     Different methods of creating CT pictures have been developed to reduce the radiation dose.~     Researchers want to see how effective these new methods are in producing accurate CT scans.~      Objectives:~      - To study new ways of taking pictures of the heart or blood vessels using computed~     tomography.~      Eligibility:~      - Adults at least 18 years of age who will be having imaging studies to help detect heart or~     blood vessel problems.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be taken to check kidney function.~        -  Participants will have a CT scan of the heart and blood vessels. A contrast agent may~          be used to improve the quality of the images. The scanning session may last up to 2~          hours.~        -  Participants will have follow-up contact 90 days after the scan, and then yearly~          contact for the next 5 years.~   "
109606|NCT01621581|"~     Background:~      - Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and~     strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain~     function. People with Parkinson's disease (PD) have problems producing dopamine in the~     brain. Researchers want to see if gene transfer can help deliver GDNF into the area of the~     brain that is damaged by PD. The gene transferred in this study, called AAV2-GDNF, may help~     produce GDNF to protect the damaged brain cells.~      Objectives:~      - To test the safety and effectiveness of AAV2-GDNF gene transfer for advanced PD.~      Eligibility:~      - Individuals at least 18 years of age who have advanced PD that is not well controlled by~     medications.~      Design:~        -  Participants will be in the study for about 5 years. There will be 18 outpatient study~          visits and a 3-day stay in the hospital. There may also be overnight stays for followup~          visits.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Tests of PD symptoms and mood and memory will be given. Imaging~          studies will be used to find the right part of the brain to infuse the gene. The~          screening visit will take place up to 60 days before surgery.~        -  Participants will have a baseline visit about a month before the surgery. For 1 week~          before the baseline visit, participants will keep a diary on any motor problems. The~          visit will involve movement tests given before and after taking a regular dose of~          levodopa.~        -  Participants will have surgery to infuse AAV2-GDNF into the brain. The surgery will~          also include a lumbar puncture (spinal tap) to collect cerebrospinal fluid. After~          surgery, participants will recover in the hospital for at least 2 days.~        -  Participants will have another lumbar puncture 6 and 18 months after surgery. This will~          be an outpatient visit.~        -  Participants will have regular followup visits after the surgery. These visits will~          include neurological tests and movement studies. Visits with a neurosurgeon will take~          place 1, 2, and 4 weeks after surgery. Additional visits will take place every 3 months~          for the first 3 years, and then at longer intervals for up to 5 years.~   "
109607|NCT01621568|"~     Background:~      - Sunitinib is drug that is approved for treating various types of cancers, including kidney~     cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works~     by blocking proteins that are responsible for cell division and growth. Some of these~     proteins can be found on thymus cancer cells. Researchers want to see if sunitinib can be~     used to treat advanced thymus cancer. It will be given to people who have had at least one~     earlier chemotherapy treatment containing platinum.~      Objectives:~      - To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has~     not responded to earlier treatments.~      Eligibility:~        -  Individuals at least 18 years of age who have advanced thymus cancer that has not~          responded to earlier treatments.~        -  At least one previous cancer treatment must have been chemotherapy treatment containing~          platinum.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor biopsies will be used to check the~          severity of the cancer.~        -  Participants will take sunitinib tablets once a day, in the morning. They will take the~          tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week~          period is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment cycles may be repeated as long as the tumor does not continue to grow and~          there are no severe side effects.~   "
109608|NCT01621555|"~     The purpose of this study is to investigate whether there is a correlation between a~     patients pain sensitivity and their subsequent post-operative pain and surgical outcome in~     arthroscopic shoulder surgery.~   "
109609|NCT01621542|"~     This clinical study is designed to evaluate the safety, immunogenicity and antitumor~     activity of WT2725. WT2725 will be administered to patients with advanced malignancies known~     to overexpress WT1~   "
109610|NCT01621529|"~     Use of positron emission tomography (PET) in determination of functional tumour volume can~     provide usable information for radiotherapy to define the irradiated volume.~      To determine the best tumour volume measure method, the investigators have chosen as model~     the breast cancer which allows us to study a stationary or moving organ by the patient~     position and belonging to a primary surgery.~      The used methodology is based on lesion volume measure in preoperative time, obtained with~     PET, and on the measure of specimen volume by the anatomic laboratory after surgery.~      This study's main objective is to compare this two measure of tumour size and secondarily to~     compare TEP with or without respiratory gating.~      The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3~     times:~      A whole body acquisition in supine position, follow by a centered tumour acquisition with~     respiratory gating, then an acquisition in prone position to immobilise the lesion.~      This study is monocentric and descriptive. It provides to include 30 patients in 1 year.~   "
109614|NCT01621477|"~     The primary aim of this protocol is to evaluate if the one-year survival is significantly~     improved in the group of patients who receive a T-cell replete haploidentical donor~     hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen.~     Study population will consist of patients (21 years or under) with hematologic malignancies~     that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be~     evaluated by the rate of transplant related mortality and the rates of moderate and severe~     graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and~     disease-free survival at one year, as well as the rates of hematopoietic recovery and donor~     engraftment and study comprehensively immune reconstitution following T-cell replete~     haploidentical transplantation.~   "
109615|NCT01621464|"~     Physiological stimulation therapy effectiveness will be proved with contractility sensor or~     CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from~     neuromediated syncope. Furthermore, not only will be investigated if this system eradicates~     syncopes, but also if the number of presyncopal episodes is reduced.~   "
109616|NCT01621451|"~     Aspirin and/or clopidogrel users are increasing due to increased prevalence of~     cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients~     having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for~     early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are~     increasing among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is~     recommended to be stopped for 5~14 days before EMR or ESD because bleeding risk during or~     after procedure. And it is recommended to restart of aspirin and/or clopidogrel as soon as~     possible if immediate bleeding during or after the procedure is not occurred in~     consideration of thromboembolic risk. However, early restarting of aspirin and/or~     clopidogrel raise the risk of delayed bleeding and the risk of complications associated with~     delayed ulcer healing. Although it is important to determine the timing of restarting~     aspirin and/or clopidogrel in consideration of complications of post-EMR/ESD ulcer and~     thromboembolic risk, there is no definite guideline about the timing of restarting aspirin~     and/or clopidogrel.~      This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the~     patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned~     to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD~     ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients~     restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients~     restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The~     primary endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end~     point is ulcer healing rate within 4 weeks.~   "
109617|NCT01621438|"~     This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel~     fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel~     disease. For this purpose, the clinical data of the patients with 3-vessel intermediate~     coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical~     needs, will be analyzed.~   "
109618|NCT01621425|"~     Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers,~     mainly breast- and metastatic castration-resistant prostate carcinoma.~      Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to~     equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly~     interindividual pharmacokinetic variation leading to toxicity and under-treatment.~      The investigators will determine which anthropometric parameters, LBM, total body weight~     (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.~   "
109619|NCT01621412|"~     The investigators believe that disclosure of HIV status could influence medication~     adherence. If disclosure leads to social support, adherence could be improved. This study~     purpose is to assess correlation between disclosure and medication adherence, and to~     describe people whose HIV status has been disclosed to.~   "
109620|NCT01621399|"~     The purpose of this study is to determine if product 55394 is safe and efficacious for the~     treatment of bacterial vaginosis.~   "
109621|NCT01621386|"~     This study will explore the utility of magnetic resonance imaging (MRI) to assess~     ventilatory defects that occur due to asthma, determine the sensitivity and specificity of~     MRI in response to drug treatment, and whether MRI can serve as a biomarker of treatment~     effects due to asthma therapy.~   "
109622|NCT01621373|"~     The aim of the study is to explore the optimal propofol dose in neonates receiving a single~     intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE~     (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective~     non-INSURE procedures (term-preterm neonates).~   "
109623|NCT01621360|"~     The objective of this study is to determine if patients with femoroacetabular impingement~     (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years~     post-operative with respect to physical function, pain, and health related quality of life,~     compared to similar patients who receive conservative management, including medication and~     physiotherapy.~   "
109624|NCT01621347|"~     The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy~     and postpartum, and to record adherence barriers and facilitators.~   "
109625|NCT01621334|"~     This research is a stage 1b developmental trial evaluating an intervention called The Men's~     Domestic Abuse Check-Up with adult men abusing their intimate partners and also struggling~     with alcohol or drug use.~   "
109626|NCT01621321|"~     This is a research project to evaluate the efficacy and safety of two different treatment~     protocols in Allergic bronchopulmonary Aspergillosis.~   "
109638|NCT01621165|"~     Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of~     mania involves directly targeting this hyperexcitable state by reducing arousal with~     antiadrenergic agents. This can be achieved by decreasing norepinephrine release by~     stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of~     high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors.~     Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress~     Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the~     treatment of mania.~   "
109972|NCT01616810|"~     The purpose of this study is to determine the validity of a screening tool which has been~     designed to detect the presence or absence of lower urinary tract symptoms in the general~     female population.~   "
109627|NCT01621308|"~     Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently.~     For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC)~     insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line~     alternative.~      Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using~     an implantable pump device improves glycaemic control and quality of life in patients with~     'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce.~      The primary objective of this study is to compare the effects of IP insulin delivery to SC~     insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII~     compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis~     (H1) is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior~     to the SC insulin treatment H1: CIPII is not inferior to SC insulin treatment~      This is an investigator initiated, open label and prospective matched-control study with a~     non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre~     (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are~     performed.~   "
109628|NCT01621295|"~     Communication is an important component of comprehensive cancer care impacting patient~     satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer~     clinical interactions makes communicating about a broad range of topics (including quality~     of life, communication, symptom control, complementary/alternative therapies, costs,~     treatment burden, prognosis, anxiety, side-effects, sexual function, palliative care~     options, etc.) especially interesting and potentially challenging. Some of these topics may~     not be routinely addressed in the clinical interaction or may require consultative support~     from other members of the comprehensive cancer care team. One frequently overlooked critical~     element in research on communication between cancer clinicians, their patients, and their~     primary care clinicians is describing real-time consultations between patients and their~     clinicians. These interactions provide rich material for assessing key psycho-social~     dynamics and identifying issues that patients find important in their care. In order to~     devise systems of care that optimize the patient experience, it is critical that clinicians~     and researchers understand, appreciate, and systematically characterize the richness and~     complexity of the decision-making process in routine cancer consultations between cancer~     patients and their treating clinicians. This study seeks to assess the patient experience in~     cancer care by observing patients and their physicians in their clinical interactions and~     following them for several months to see how their care went. By describing in-depth the~     conversations and experiences of patients in these clinical interactions, this study will~     lay the foundation for practice-based interventions to optimize patients' interactions with~     their cancer care teams.~   "
109629|NCT01621282|"~     Running successful journal club is of the important goals for postgraduate education.In this~     study, the effect of a 6-month interactive educational course on journal clubs of Mashhad~     Dental school was observed using a valid and reliable checklist(r=0.74). Data will be~     evaluated and compared using spss software by t-test.~   "
109630|NCT01621269|"~     Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12~     months~   "
109631|NCT01621256|"~     The purpose of this study is to determine whether ancrod is effective and safe in the~     treatment of sudden sensorineural hearing loss (SSHL).~   "
109632|NCT01621243|"~     People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and~     gemcitabine in combination with an investigational agent called necuparanib (M402). It is~     made from heparin, which is a well known blood thinner. Blood thinners have been shown in~     prior animal and human studies to have anti-cancer effects. Necuparanib has been~     re-engineered from heparin to have much lower blood thinning activity while keeping the~     anti-tumor activity. The investigators are testing whether necuparanib administered in~     combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel~     and gemcitabine.~   "
109633|NCT01621230|"~     The aim of this study is to measure the effects of bupivacaine administered via epidural~     catheters on indices of motor blockade ascertained during the second stage of labor. This is~     a randomized, double-blind, controlled trial designed to address the primary research~     question: Does bupivacaine lengthen the second stage of labor? The secondary research~     question is: Is there other evidence of motor blockade attributable to bupivacaine during~     the second stage of labor?~      The investigators know from prior studies that the length of the second stage in nulliparous~     women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The~     investigators hypothesize in this now proposed study that epidural analgesia with~     bupivacaine will significantly increase this baseline from 28 minutes to 37 minutes or more~     (a 33% increase) thus implicating motor blockade. Baseline data for the Bromage and Breen~     scores during the second stage as well as the uterine contractility data are not available~     as these indices of motor blockade have not here-to-fore been studied in this context.~      Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at~     term receive continuous epidural infusions with bupivacaine during the first and second~     stages of labor. Such women will be identified when admitted for scheduled inductions at~     Parkland. After informed consent is obtained standard management of labor induction will be~     provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I~     will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e.~     10 cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see~     study procedure below). Both the patient and the caregiver will be blinded as to whether the~     patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33%~     increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a~     total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and~     given that approximately 1000 women meet the inclusion criteria each year at Parkland, the~     investigators project that this study could be completed in 12 months.~   "
109634|NCT01621217|"~     -  To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and~          mitomycin C when given together with the antibody cetuximab in patients with locally~          advanced cancer in the anal region~        -  To evaluate acute toxicity~        -  To evaluate late toxicity~        -  To evaluate response rate~        -  To evaluate recurrence free survival~        -  To evaluate overall survival~   "
109635|NCT01621204|"~     This is a study to investigate if eltrombopag can be used instead of Intravenous Immune~     Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they~     undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of~     ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need~     surgery have to get treatment to increase their platelet count. IVIG is commonly used for~     this purpose but eltrombopag may be more effective and convenient for patients.~   "
109636|NCT01621191|"~     The purpose of the study is to assess the safety and efficacy of duloxetine in participants~     with fibromyalgia at long-term use.~   "
109637|NCT01621178|"~     The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide~     compared to insulin glargine in the treatment of participants with type 2 diabetes and~     moderate or severe chronic kidney disease.~   "
109639|NCT01621152|"~     Introduction: Acute kidney injury (AKI) increases mortality, hospital cost, and rate of~     progression toward end stage kidney disease 1-4. Early diagnosis and management of AKI is~     known to improve the above mentioned outcomes.~      Hypothesis: the investigators will design and validate an electronic surveillance tool to~     screen all the ICU admissions for the earlier, more efficient diagnosis of AKI and as a~     result improve the outcome of AKI in ICU patients.~      Methods: the investigators plan to use the patient database, and AKIN (AKI network)~     definition to design an electronic alert system to allow clinicians discover patients who~     develop AKI. Then a randomized clinical trial will be conducted to compare earlier~     intervention (based on Kidney Disease: Improving Global Outcomes [KDIGO] guidelines)~     initiated by AKI sniffer alert to the conventional management provided by primary physician~     in ICU.~   "
109640|NCT01621139|"~     The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the~     requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite~     recovery process, and 4) improve the quality of life.~   "
109641|NCT01621126|"~     In a study performed by the Harvard Shoulder Service, it has been documented that there is a~     significant incidence of neurologic complications of the Latarjet procedure for shoulder~     instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these~     nerve palsies were transient, however 2 had not yet recovered fully at time of latest~     follow-up and returned to the operating room for exploration and neurolysis of the axillary~     nerve and brachial plexus.~      By using intra-operative neuromonitoring to determine exactly when there is a potential~     nerve injury during the procedure, the investigators will be able to modify what the~     investigators do at that step of the procedure, in order to decrease or possibly even~     eliminate the risk of neurologic injury.~   "
109642|NCT01621113|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     treatment with dalfampridine in combination with locomotor training in persons with chronic,~     motor incomplete SCI.~   "
109643|NCT01621100|"~     The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily~     OROS (Osmotic Release Oral System [a controlled release oral medication delivery system in~     the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.~   "
109644|NCT01621087|"~     The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a~     cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction.~     However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct~     from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973)~     was a randomized controlled secondary CHD prevention trial testing whether selectively~     increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival.~     A full analysis of mortality outcomes has not been published. The investigators recovered~     the original SDHS dataset, which included detailed longitudinal dietary, smoking and coded~     mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD~     mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also~     permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.~      Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD~     mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed~     mortality differences.~   "
109645|NCT01621074|"~     During endurance exercise in the heavy and severe intensity domains, the rate at which~     metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and~     extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium~     bicarbonate, as a nutritional supplement, has gained attention over the past decades,~     because it might delay of offset fatigue. To date, there is a controversial discussion about~     which delivery mode (amount and frequency) might be best in optimizing endurance~     performance. Since the high ion load consequent to multiple ingestions might increase plasma~     volume, and consequently decrease bicarbonate concentrations, single acute ingestion could~     be more beneficial. However, in multi-day competitions or tournaments it might be necessary~     to use the supplement on a daily basis. Here, the investigators aim at investigating the~     effects of single dose or multiple dose (on five consecutive days) administration of~     bicarbonate vs. placebo increases endurance performance and acid-base homeostasis in trained~     male endurance athletes.~   "
109646|NCT01621061|"~     High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term~     residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise~     performance and hypertension in the pulmonary circulation. Whether sleep related breathing~     disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in~     highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the~     current study will investigate whether highlanders with high altitude pulmonary hypertension~     have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.~   "
109647|NCT01621048|"~     Radiotherapy plays an important role in the curative treatment of head and neck cancer. This~     treatment however is associated with significant acute and late toxicity with xerostomia and~     dysphagia severely implicating the patient's quality of life. With highly conformal~     radiotherapy techniques it is possible to decrease de dose to the organs at risk while~     maintaining adequate doses to the tumour. In order to adequately register the effect of~     these techniques it is imperative to obtain standardized information on the acute and late~     treatment effects. With this study the investigators want to evaluate this toxicity using~     standardized and validated questionnaires during follow-up. This data will then be~     correlated to the doses delivered to the specific organs at risk.~   "
109648|NCT01621035|"~     The purpose of the present study is to evaluate the validity of 2 objective measures of~     physical activity among older adults. In addition, the investigators will examine the~     influence of functionality, walking aids, walking speed and step length on the accuracy.~   "
109649|NCT01621022|"~     Focus of this study was to determine if bupropion was more effective for smoking cessation~     when used alone or combined with nicotine gum.~   "
109650|NCT01621009|"~     The purpose of this study was to determine if bupropion plus counseling was more effective~     than bupropion alone or counseling alone in helping smokers quit smoking.~   "
109697|NCT01620385|"~     The primary purpose of the research is to study how individuals who wear cochlear implants~     process sounds in noisy environments and also whether newly designed programs can help~     improve the communicative ability of cochlear implant patients in noisy situations.~   "
109651|NCT01620996|"~     Study Purpose and Design~      The goal of this study is to improve CVD risk in a primary care adult population, with the~     following primary objectives~        1. To improve management of global cardiovascular risk of patients within two primary care~          practices, thereby improving their overall cardiac health.~        2. To increase patient compliance with lifestyle aimed at pharmaceutical interventions~          aimed at decreasing global cardiovascular risk.~      Secondary objectives of the study are:~        1. To examine the utility of a process to improve the management of global cardiovascular~          risk of patients within two primary care practices.~        2. To explore the utility of a process that links primary care practices with existing~          community resources in order to manage cardiac risk factors better among individuals~          within those primary care practices.~        3. To determine the economic impact of a global risk assessment and management process~          within a primary care setting.~   "
109652|NCT01620983|"~     Patients undergoing knee replacement surgery and who have high levels of pain~     catastrophizing are at risk for poor outcome. The clinical trial is designed to determine if~     a pain coping skills training intervention delivered by physical therapists and supervised~     by psychologists is more effective at reducing pain and improving function and is more cost~     effective than arthritis education or usual care.~   "
109653|NCT01620970|"~     Salvage chemotherapy for advanced urothelial cancer (UC) yields suboptimal response rates of~     15-40%, a median progression-free survival of 2-4 months and a median overall survival of 6~     months. A rationale for targeting angiogenesis in UC is supported by preclinical evidences~     and early signals of clinical activity of anti-VEGF TKI as demonstrated by our group with~     the use of pazopanib.~      Despite this activity, progression inevitably occurs and mechanisms determining resistance~     to conventional anti-angiogenic agents are under investigation.~      PF-03446962 (Pfizer Inc) is a novel fully human monoclonal antibody (mAb) against ALK1 with~     dose-dependent antiangiogenic activity as demonstrated in nonclinical studies in a chimera~     mouse model bearing human tumor xenograft. The investigators suggest that PF-03446962 may~     increase current results for patients with advanced urothelial cancer failing upfront~     chemotherapy due to its mechanisms of action. Due to the lack of reliable and reproducible~     predictors of response as well as of imaging tools to assess tumor response, the trial will~     provide incorporation of 18FDG-PET/CT and contrast-enhanced ultrasound to stage and evaluate~     response of urothelial cancers, together with standard imaging modalities (RECIST criteria).~     Blood and tissue samples will be collected for translational purposes.~   "
109654|NCT01620957|"~     Several studies in healthy volunteers have suggested that the synchronized functional~     connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and~     when required, a switch in the activity between the DMN and other networks involved in~     specific congnitive functions, would occur. This interaction permit to make the hypothesis,~     that baseline brain activity is likely to shape our ongoing  stream of consciousness  and~     could correlate with conscious perception. The investigators hypothesized that DMN~     connectivity strength would be related to the level of consciousness of brain-damaged~     patients. The investigators will follow severely brain-injured patient in coma. Clinical~     examination using standardized behavioural scales: FOUR score (Full Outline of~     UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI~     (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30~     (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state~     between 30 and 60 days, an additional clinical and brain imaging assessment will be~     performed to identify related changes in brain activity (visit 1*) Monitoring of vital~     parameters will be performed in patients by a senior anaesthesiologist throughout the~     experiment.~   "
109655|NCT01620944|"~     The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency~     virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week~     48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either~     one additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs~     [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].~   "
109656|NCT01620931|"~     This randomized, observer-blinded, placebo-controlled study will assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.~     Subjects will be randomized in cohorts to receive single ascending intravenous or~     subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4,~     with a safety follow-up of 15 weeks after dosing.~   "
109657|NCT01620918|"~     -  Baseline:~             -  Standard preparation of the osteotomy~             -  Placement of 2 dental implants~             -  On each implant one of both types of healing abutments is placed~             -  Suturing~             -  Standardized radiography to measure bone-levels at baseline~             -  Digital impression of the surrounding gingiva with an intra-oral scanner (a~               non-invasive method) to measure the baseline level of the gingiva~        -  2 weeks after Baseline:~           o Removal of the sutures~        -  4 weeks after Baseline:~             -  A 2nd digital impression of the soft tissue with an intra-oral scanner~             -  Collecting crevicular fluid by placing paperpoints in the provided apertures in~               the healing abutments for 60 seconds without bleeding.~             -  Measuring of the pocket depth in the provided apertures in the healing abutments~               with an automated probe.~             -  Removal of the Healing Abutment with the attached soft tissue en-bloque.~             -  Placement of a new, regular, Encode Healing Abutment.~        -  10 weeks after Baseline:~             -  Start of standard prosthetic procedure. In this study we expect that the soft~               tissue attachment (i.e. the gingival attachment) will be stronger and earlier~               achieved at the nano-structured healing abutments than at the normal, uncoated~               healing abutments. This would lead to a more stable soft tissue complex on the~               long rung and thus providing a more predictable aesthetic outcome. Secondly, a~               stronger attachment would mean a stronger barrier against micro-organisms and~               might influence the occurrence of peri-implantitis.~   "
109658|NCT01620905|"~     Cervical spine manipulation has been shown to be helpful for some patients with neck pain.~     This study sought to determine factors which were predictive of which patients with neck~     pain would benefit from manipulation.~   "
109876|NCT01618058|"~     The purpose of this trial is to determine if exposure to ARV-containing investigational~     products in IPM clinical trials will impact the natural history of HIV infection as measured~     by the virologic, immunologic and clinical outcomes of participants who become HIV-positive~     during the IPM 027 trial.~   "
109659|NCT01620892|"~     The study seeks to evaluate the condition of patients 5 years after having undergone partial~     knee replacement for localized osteoarthritis of the knee. Participating patients will~     voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after~     surgery. The aims of the study are to describe the survivorship of the prostheses and the~     clinical results of patients, and to elucidate and describe the natural history disease of~     the untreated knee joint compartments after a partial replacement. Patients who were~     operated by the principal investigator 5 years previously will be invited to participate.~     The study is observational in nature; there is no element of experimentation or test of an~     intervention.~   "
109660|NCT01620866|"~     The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR),~     an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning,~     quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.~   "
109661|NCT01620853|"~     The purpose of the study is the identification of chromosomal aberrations in non-small cell~     lung cancer (NSCLC) .~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ALK FISH stained lung samples.~   "
109662|NCT01620840|"~     Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different~     formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is~     approved as adjunctive therapy in epilepsy patients with partial onset seizures with or~     without secondary generalization. The i.v. solution is used in patients in which oral~     administration is not possible or adequate. Bioequivalence with oral tablets and safety~     could be demonstrated in healthy volunteers and in patients switched from tablets to~     Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single~     loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect~     systematically data on the safety, tolerability and administration procedures when Lacosmide~     i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help~     treating physicians to optimize the use of Lacosamide i.v. in clinical routine.~   "
109663|NCT01620827|"~     This study is being conducted to evaluate the hypothesis that study subjects will be more~     responsive to follow-up phone calls made from personal cell phone numbers than from hospital~     landline numbers. To evaluate this, study subjects previously enrolled in a cardiac~     biomarker study (the Early Identification of Acute Coronary Syndrome study) were randomized~     to receive their follow-up phone calls (the calls associated with the Early ID study occur~     at 30 days and 1 year after initial enrollment) from either a hospital office landline or~     from the personal cell phones of the research assistants making these calls. This was done~     as a 1:1 randomization. The number of call attempts required to reach the study subjects~     were recorded as the calls were made and the date of successful follow-up was recorded once~     contact was made.~   "
109664|NCT01620814|"~     Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening~     before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED~     PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal~     dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic~     hysteroscopy.~      Population: It was planned for performing to 95 women who appealed to gynecology polyclinic~     and will be performed diagnostic hysteroscopy.~      Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as~     randomize to three groups. It was planned that none procedure will be applied to group 1 for~     cervical ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups~     2 and 3, respectively.~   "
109665|NCT01620801|"~     Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX~     (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor~     concentrates, in response to bleeding. This study will focus on the severe, most common type~     of hemophilia B. This study plans to use a virus called adeno-associated virus (AAV), which~     in nature causes no disease, and can be engineered to deliver the human FIX gene~     (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. This study will use the~     AAV8-hFIX19 vector.~   "
109666|NCT01620788|"~     The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg /~     losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.~   "
109667|NCT01620775|"~     This study is designed to assess:~      Hypothesis #1: That there is a significant central pain component in a distinct subset of~     patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful~     diabetic neuropathy(PDN.)~      Hypothesis # 2: To establish a reliable strategy for differentiation of central pain~     predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back~     pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features,~     experimental pain testing and magnetic resonance(MR) Spectroscopy.~   "
109668|NCT01620762|"~     The purpose of this study is to compare the treatment effect of two treatment regimens of~     Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue~     medication usage and Quality of Life.~   "
109669|NCT01620749|"~     The purpose of this study is to investigate the safety and potential effectiveness of the~     imaging compound 18F MEL050 for finding sites of melanoma.~   "
109670|NCT01620736|"~     This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1)~     viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2~     months of treatment and 1 month of followup. The study will assess the effect of raltegravir~     on virus load in peripheral blood lymphocytes, level of virus gene expression, and sites of~     viral integration.~   "
109671|NCT01620723|"~     The purpose of this study is to evaluate if the developed theory and evidence based~     programme has a positive effect on mother's breastfeeding self efficacy, establishing an~     effective breastfeeding and breastfeeding duration after short time hospitalization.~   "
109672|NCT01620710|"~     This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with~     higher daily doses and shorter total treatment time compared to standard fractionation) of~     the prostate bed with or without the pelvic lymph nodes.~   "
109699|NCT01620359|"~     The goal of this prospective, non-randomized, single-arm, multi site, international study is~     to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in~     the ablation of breast cancer and of MRI.~      The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume~     in a treatable and device accessible location.~   "
109674|NCT01620684|"~     This project will examine whether short-term (over a 12-hour period) pharmacological~     lowering of the stress hormone 'cortisol' improves the nervous system response to food~     intake in overweight or obese individuals who have metabolic syndrome.~      The investigators know from our previous research that overweight/obese persons who are~     insulin resistant, have a blunted sympathetic nervous response to carbohydrate ingestion.~     This means that they are less able to dissipate energy from caloric intake, which would~     favour the maintenance of the obese state. Cortisol adversely impacts on insulin action and~     transport into the brain and cortisol levels are often elevated in persons with central~     (abdominal) obesity.~      A randomized, double-blind, placebo controlled, cross-over design will be used to compare~     the effects of overnight treatment with metyrapone (15 mg/kg at midnight and 15 mg/kg at 6~     am) versus placebo on sympathetic nervous system activity in response to a standard 75-g~     oral sugar (glucose) tolerance test. A 2 week washout will separate treatments.~      Metyrapone is a drug that reversibly inhibits the enzyme 11beta-hydroxylase, and therefore~     the production of cortisol. It is used clinically to test the activity of the adrenal gland~     (the key site of cortisol production) and the pituitary gland. The investigators anticipate~     that at the dosage used, it will lower blood cortisol concentration by 44 to 64% during the~     experimental morning.~      The study protocol comprises two screening visits and two experimental mornings. Key~     procedures will include:~        -  Assessment of insulin action (sensitivity) using the gold standard 'clamp' method.~        -  Measurement of sympathetic nervous system activity by both biochemical methods (isotope~          dilution which provides a measure of the apparent rate of release of~          'noradrenaline'-the key neurotransmitter in the sympathetic nervous system) and direct~          intra-neuronal nerve recordings from the peroneal nerve in the lower leg.~        -  Indirect calorimetry to assess resting metabolic rate and the response to sugar~          ingestion.~        -  DEXA scan to quantify fat and lean mass.~        -  Assessment of arterial elasticity and calf blood flow by non-invasive methods.~        -  A standard 75g oral sugar tolerance test.~      The results will provide important new information regarding the role of cortisol on nervous~     system function in overweight/obese individuals.~   "
109675|NCT01620671|"~     The concept of enhanced recovery after surgery has become increasingly popular in elective~     abdominal surgeries. Yet, the role of this concept has not been described in emergency~     procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery~     in patients with perforated peptic ulcer.~   "
109676|NCT01620658|"~     The primary objective of the present trial is to compare the radiation attenuation provided~     by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection~     (fabric cap, basically no protection) as measured in % radiation attenuation) during 150~     days of fluoroscopy guided cardiology interventions. The second objective is to compare the~     operator comfort (rated on a visual analog scale) of wearing the XPF protection caps~     compared to the standard fabric caps.~   "
109677|NCT01620645|"~     The UK Medical Research Council (MRC) together with the Association of British~     Pharmaceutical Industries (ABPI) have recently funded a program designed to foster~     collaboration between academic COPD researchers and the pharmaceutical industry in the UK,~     with the aim of developing and furthering our research capacity and expertise for the~     benefit of patients living with this prevalent and disabling condition. This builds on the~     strong international track record of COPD research in the UK. The program is divided into~     four work packages (WP1-4), each with specific aims. WP1 will collate and establish data~     from patient cohorts and share this information through the development of knowledge~     management platforms. WP2 will specifically assess how airway micro-organisms impact on COPD~     and how the effects of bacteria and viruses may be modified. WP3 is concerned with tissue~     injury and repair which are fundamental processes in the development of COPD. WP4 will~     examine in detail the potential for improving patient outcomes by targeting the skeletal~     muscle dysfunction that can profoundly affect exercise capacity.~   "
109678|NCT01620632|"~     The purpose of this research study is to collect data on the technical aspects of~     Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of~     patients with Roux-en-Y gastric bypass surgery.~   "
109679|NCT01620619|"~     The null hypothesis is that there is no statistical difference between the two treatment~     groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion~     repair with rotator interval closure will have lower quality of life and less external~     rotation compared to patients who undergo a Bankart lesion repair alone. No difference will~     be observed for recurrence rate between the two treatment groups~   "
109680|NCT01620606|"~     Functional abdominal pain (FAP) is a common complaint of childhood, associated with~     considerable health care costs, disruption of normal activity, emotional distress, and~     long-term health effects. The study will test a treatment approach which, if successful,~     would substantially change the treatment for FAP and potentially for a wide range of~     childhood medical problems where parental responses to symptoms contribute to these adverse~     effects. The study would also provide a model which would be much more accessible than~     traditional face-to-face therapies to a broader range of families in need than are currently~     served.~   "
109681|NCT01620593|"~     Prostate cancer is the most common non-cutaneous cancer in men. Patients with recurrent or~     metastatic prostate cancer are treated with androgen-deprivation therapy, often termed~     castration therapy. While the short and medium term benefits of castration are clear in~     relation to therapeutic efficacy in patients with prostate cancer, it is now appreciated~     that the resulting hypogonadism associated with castration is responsible for adverse~     consequences or metabolic syndrome that include increase in body mass index (BMI) and fat~     mass, hyperinsulinemia and insulin resistance, hyperlipidemia, reduced lean body mass (LBM)~     and muscle strength, osteoporosis, sexual dysfunction, poor quality of life and higher~     cardiovascular mortality. Lower testosterone levels in men independently predict the~     development of metabolic syndrome. Low testosterone levels in men are associated with~     insulin resistance and diabetes. Metformin is commonly prescribed for the treatment of type~     II diabetes because it lowers both glucose and insulin levels. Studies show preliminary~     evidence that metformin might have both antineoplastic and chemopreventative activity.~     Castration therapy decreases insulin sensitivity, adversely alters lipid profiles and~     results in weight gain, and it may be associated with a greater incidence of diabetes and~     cardiovascular disease. Little is known about the optimal strategy to mitigate the adverse~     metabolic effects of castration in men with prostate cancer. The rationale for using~     metformin in castrated men with advanced prostate cancer stems from the observation that~     castration therapy is associated with the metabolic syndrome, hyperinsulinemia and insulin~     resistance. Furthermore, reports that hyperinsulinemia stimulates insulin receptor~     expression on prostate cancer leading to tumor growth and development of castrate resistant~     prostate cancer suggest metformin through its activation of the AMPK-LKBI pathway reduces~     liver gluconeogenesis secondarily decreasing insulin levels may circumvent tumor growth and~     resistance to castration therapy. More importantly, evidence that metformin inhibits the~     mTOR pathway implicates an added therapeutic benefit as an anti-cancer agent.~   "
109682|NCT01620580|"~     Self-management intervention may decrease symptom burden and improve functioning over time.~   "
109698|NCT01620372|"~     The FCCSS is a multicentric national large-scale collaborative population-based study of~     children treated for a solid tumor before 2000 in France and before the age of 19 years.~      The study is concerned by improving knowledge about the long-term effects caused by cancer~     and its treatments including adverse health and social outcomes.~      The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes~     that may occur after a cancer treatment and to prevent them by providing adapted follow-up~     care.~      The cohort will be followed for up to 20 years from 2011.~   "
109973|NCT01616797|"~     The research proposes to use an innovative solution to shape brain circuits that support~     executive function and emotion reactivity -using targeted neurobehavioral intervention.~   "
109683|NCT01620567|"~     Cognitive impairment is also a major risk factor for development of dementia later in life.~     Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin~     may be important in cognitive function in the elderly. Avocados are a source of these~     carotenoids. The investigators study evaluates long-term avocado intervention as a treatment~     strategy for age-related cognitive impairment which could possibly prevent the onset of~     dementia. The investigators have also shown that lutein supplementation significantly~     improved verbal fluency scores in healthy older women. Based on these findings, the next~     logical step will be to investigate the ability of lutein and zeaxanthin contained in~     avocados to influence cognitive function in older adults. The investigators hypothesize that~     there will be a significant increase in cognitive function measures in older adults provided~     with meals containing 1 avocado/day at the end of 6 months, while no significant~     improvements will be observed in older adults given daily meals containing chickpeas and/or~     potatoes.~      The proposed study is designed as a randomized, placebo controlled trial that tests the~     effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults.~     Secondary analyses will determine whether baseline macular pigment (lutein in retina which~     canbe measured non invasivley) density predicts relative effectiveness of the intervention~     on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and~     inflammation.~   "
109684|NCT01620554|"~     Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5~     parallel groups (dose-range).~   "
109685|NCT01620541|"~     End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain,~     dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking~     for even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have~     two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty~     (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two~     procedures, and no randomized controlled trials (RCTs) have been performed.~      The investigators will compare the following in subjects undergoing ankle arthrodesis and~     ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual~     basis up to ten years.~        1. Overall physical function and ankle specific function~        2. Ankle pain intensity and interference with activities~        3. Activity levels~        4. Overall general health~        5. Post-surgical complication rates~      The investigators will also identify prognostic factors that are predictive of higher~     physical function, ankle specific function, reduced pain, improved general health, and~     overall patient satisfaction.~   "
109686|NCT01620528|"~     A randomized study evaluating the safety and efficacy of elagolix in the management of~     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.~   "
109687|NCT01620515|"~     This study is designed to evaluate the safety and efficacy of a single injection of NX-1207~     for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients~     currently undergoing active surveillance. Study participants currently on active~     surveillance will be randomized either to treatment with a single intraprostatic injection~     of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued~     active surveillance). Blinded efficacy evaluation will be by a second post-treatment~     prostate biopsy.~   "
109688|NCT01620502|"~     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3~     polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part~     is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients~     with IFN-induced depression.~   "
109689|NCT01620489|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to investigate the efficacy and safety of liraglutide in subjects with type 2~     diabetes and moderate renal impairment.~      The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin~     regimen.~   "
109690|NCT01620476|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of liraglutide in healthy Japanese male subjects.~   "
109691|NCT01620463|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.~   "
109692|NCT01620450|"~     This trial is conducted in Japan. The aim of this trial is to compare insulin aspart~     produced by current process and the NN2000 process in healthy Japanese subjects.~   "
109693|NCT01620437|"~     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese~     subjects.~   "
109694|NCT01620424|"~     This trial is conducted in Japan. The aim of this trial is to investigate the~     pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and~     biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.~   "
109695|NCT01620411|"~     This study aims to investigate the relative effectiveness of two different pain management~     plans for injuries sustained while active duty in the military. One arm of the study has~     subjects undergo standard comprehensive medical management, while the other adds the~     placement of a spinal cord stimulator, a common procedure for the alleviation of pain.~   "
109696|NCT01620398|"~     There are no studies exploring the benefits of a diet composed of typical Brazilian food in~     the secondary prevention of cardiovascular diseases. Randomized studies show that the~     Mediterranean diet is beneficial for patients with established cardiovascular disease or in~     risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one~     of main references for dietary guidelines for treatment and prevention of CVD in Brazil and~     the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet~     are not widely available, may be expensive or are not part of population eating habits. So,~     the prescription of the Mediterranean diet intervention for cardiovascular disease to the~     Brazilian population may not be feasible, leading to a low adherence. In this context,~     patients with established CVD have a low compliance to nutritional prescription. The BALANCE~     Program, considers 3 concepts: a) A dietary prescription guided by nutritional content~     recommendations from the Brazilian national guidelines; b) A nutritional education program~     based on fun, playful strategies and suggestions of affordable foods; and c) Intensive~     follow-up through one-on-one visits, group sessions, and phone calls. This is the first~     proposal to use these concepts concurrently with the objective to increase adherence of~     secondary prevention patients to the diet proposed by the guidelines. Therefore, this trial~     will investigate the effects of the Program on reducing cardiovascular events - such as~     cardiac arrest, acute myocardial infarction (AMI), stroke, myocardial revascularization,~     amputation for peripheral arterial disease, and hospitalization for unstable angina - or~     death in patients with established CVD. Moreover, it will evaluate the effects of the~     dietary program on reducing CV factors, such as BMI, waist circumference,~   "
140335|NCT01217918|"~     Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when~     administered to healthy Japanese subjects once a day (QD) for 10 days.~   "
109700|NCT01620346|"~     The objective of this study was to evaluate the advanced maternal age as a rationale for~     performing intracytoplasmic morphologically selected sperm injection (IMSI).~      This prospective randomized study included couples undergoing intracytoplasmic sperm~     injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were~     randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI,~     n = 33). The groups were compared with regard to fertilization rate, percentage of~     high-quality embryos, implantation, pregnancy and miscarriage rates.~   "
109701|NCT01620333|"~     This trial is conducted in Japan. The aim of this trial is to investigate the~     pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70~     (NN-X14Mix70) in Japanese healthy volunteers.~   "
109702|NCT01620320|"~     Left main stenosis use to be treated by bypass but with the improvement of angioplasty~     techniques, an increasing number of patients are submit to left main coronary angioplasty.~     Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no~     precise recommendation concerning the follow up of these patients exist. The investigators~     ought to determine if stress echocardiography can predict left main intra stent stenosis as~     well (non inferiorly)as control angiography that use to be done.~   "
109703|NCT01620307|"~     Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells~     infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking~     activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe~     H1N1 pneumonia with respiratory failure, this study was conducted.~   "
109704|NCT01620294|"~     After open colorectal surgery the surgical site infection (SSI) is very high among abdominal~     surgeries. The goal of the investigators randomized, prospective, multicentric,~     internet-based study is to compare rate of SSI after surgery of colon and rectum by using~     triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are~     involved in this study. Two arms are separated by computer randomization at abdominal wall~     closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus).~     Triclosan is an antiseptic material which the investigators hope will provide better local~     infection control at the site with reducing the risk of bacterial colonisation.~   "
109705|NCT01620281|"~     This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive~     motion device in relieving of mild to moderate non-specific low back pain.~   "
109706|NCT01620268|"~     This study will evaluate the clinical efficacy and safety of a combination of leflunomide~     and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the~     purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney~     transplant loss from viral damage, acute rejection or both.~   "
109707|NCT01620255|"~     To determine the dose or doses of PF-00547659 that will be the most effective to improve or~     halt the disease symptoms in patients with moderate to severe ulcerative colitis.~   "
109708|NCT01620242|"~     This is a multi-center phase II study assessing whether cabazitaxel could be efficient for~     treatment of recurrent or metastatic head and neck cancer after failure of cisplatin,~     cetuximab and taxanes.~   "
109709|NCT01620229|"~     This phase I/II trial studies the side effects and best way to give brentuximab vedotin and~     to see how well it works after donor stem cell transplant in treating patients with~     hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block~     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal~     antibodies may kill cancer cells that are left after donor stem cell transplant.~   "
109710|NCT01620216|"~     This phase II trial studies how well targeted therapy works in treating patients with acute~     lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of~     improvement or does not respond to treatment. Testing patients' blood or bone marrow to find~     out if their type of cancer may be sensitive to a specific drug may help doctors choose more~     effective treatments. Dasatinib, nilotinib, sunitinib malate, sorafenib tosylate, and~     ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving targeted therapy based on cancer type may be an effective~     treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.~   "
109711|NCT01620203|"~     Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can~     have considerable effects on neurodevelopmental outcome.~      The investigators showed that preterm infants with severe ICH have decreased cerebral~     oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of~     decreased cerebral oxygenation in preterm infants and the effects on cerebral function are~     unknown.~      This longitudinal observation study will evaluate physiologic parameters to determine trends~     in cerebral oxygenation and function in preterm infants with ICH in comparison to infants~     without ICH.~   "
109712|NCT01620190|"~     This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle~     formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat~     patients with breast cancer. Doctors want to know if Abraxane is safe and effective in~     treating patients with lung cancer that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor~     (EGFR) mutations.~   "
109713|NCT01620177|"~     The purpose of this study is to expand understanding of the effects of cannabis on driving~     performance with and without the presence of low levels of alcohol.~      This project will involve the development a of a protocol and driving environment that is~     sensitive to the effects of cannabis on driving performance by building on prior driving~     situations used previously for testing the effects of alcohol on driving.~   "
109744|NCT01619774|"~     The goal of this clinical research study is to learn if the combination of 2 drugs~     dabrafenib and trametinib can help to control melanoma that has or has not spread to the~     brain. The safety of this drug combination will also be studied.~      Dabrafenib is designed to block the mutated BRAF protein. This mutation is only found in~     moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the~     growth of or kill cancer cells that have the protein.~      Trametinib is designed to block certain proteins that cause cancer cells to grow and~     multiply. This may cause the cancer cells to die.~   "
142474|NCT01189760|"~     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to~     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)~   "
109714|NCT01620164|"~     Parkinson's disease is characterized by motor deficits, improved by dopaminergic intakes.~     Besides motor symptoms, visual troubles are observed in patients with Parkinson's disease,~     in particular spatial orientation problems including 3D vision. However, although these~     visual disturbances are commonly reported by the patients and their family in our clinical~     experience, they have not been the subject of specific clinical studies yet.~      Parkinsonian patients report deficits in 3D vision leading to a loss of visuomotor ability,~     locomotor functions and to falls. Despite these frequent complaints, little is known about~     3D vision in Parkinson's disease. The investigators want in this project to precisely~     estimate 3D deficits in parkinsonian patients by assessing their psychophysical performances~     in 3D vision tasks to compare to age matched control subjects' performances.~   "
109715|NCT01620151|"~     Primary: To compare the post-operative pain in patients with neck extension and without neck~     extension.~      Secondary: To determine the benefit of neck exposure and peri-operative complications, which~     include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and~     hypocalcaemia in both groups.~      Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less~     post-operative pain and there are no significant difference of post-operation complications~     between both groups.~   "
109716|NCT01620138|"~     There are no available medical treatment options for patients with non-functioning pituitary~     adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured~     by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA)~     expression levels and immunohistochemistry analysis might end with a better understanding of~     these tumors. Besides that, it will be assessed the in vitro and in vivo responses to~     pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be~     compared with the receptor expressions which may be a tool as a predicting element of the~     response to these compounds.~   "
109717|NCT01620125|"~     Recent data suggest that the trillions of bacteria in the investigators gastrointestinal~     tracts (gut microbiota) can function as an environmental factor that modulates the amount of~     body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant~     to developing diet-induced obesity and have lower fasting insulin and glucose and improved~     glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in~     fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by~     reducing lipid absorption and inflammatory status. However, there are no studies to the~     investigators knowledge that address whether probiotic supplementation improves glucose~     metabolism in type 2 diabetes patients.~   "
109718|NCT01620112|"~     The purpose of this study is to determine whether different clonidine concentration on~     axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the~     sensory and motor block onset time and duration, postoperative analgesia duration,~     postoperative pain intensity~   "
109719|NCT01620099|"~     Asthma is an inflammatory disease affecting the whole respiratory system, from central to~     peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or~     without long-acting β2-adrenoceptor agonists (LABA), is the cornerstone of asthma management~     [GINA Guideline - available at www.ginasthma.com]. Nevertheless, a considerable subset of~     asthmatic patients neither benefits from ICS nor gain optimal asthma control even with~     ICS/LABA combinations.~      The involvement of the distal lung, i.e. the peripheral membranous bronchioles < 2 mm in~     diameter (so-called small airways), in the pathogenesis of asthma has been extensively~     investigated and its significance debated. However, whether specifically targeting distal~     lung abnormalities can lead to further clinical benefit is still an open question. In this~     context, interest has been raised by hydrofluoroalkane (HFA) pressurised metered-dose~     inhalers, which can deliver compounds with a mass median aerodynamic diameter that is~     significantly smaller than other available devices, leading to increase peripheral airways~     drug deposition.~      Up to 30% of asthmatic patients smoke, mirroring the rate found in the general population.~     Several data document that smoking habit negatively affect corticosteroid efficacy in~     asthma. In particular, asthmatic patients who smoke experience faster lung function decline,~     increased frequency of exacerbations and reduced asthma control despite being regularly~     treated. Several molecular mechanisms have been proposed to address the issue of reduced~     corticosteroids responsiveness in smoker patients. However it has been never investigated~     whether reduced corticosteroid responsiveness in asthmatic patients who smoke can be related~     to more severe small airways involvement leading to impaired distribution or impaired~     peripheral deposition of inhaled corticosteroids. If this is the case, asthmatic patients~     who smoke might benefit from a pharmacological approach able to target and to reach small~     airways.~   "
109720|NCT01620086|"~     This study compares the efficacy of low and high frequency repetitive transcranial magnetic~     stimulation (rTMS) as a means of treating subjects with schizophrenia. Magnetic pulses~     delivered over the scalp cause brain activity. This activity has been shown to help decrease~     the intensity and frequency of auditory hallucinations (AH) in schizophrenia. The~     investigators will compare whether low or high frequencies work best. The investigators will~     also examine what changes occur in the brain that are related to improvement.~   "
109721|NCT01620073|"~     The investigators hypothesize that home based HIV counseling and testing can increase male~     partner uptake of HIV testing during pregnancy.~      The investigators study aims through a randomized clinical trial to determine whether a~     home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake~     of HIV counseling and testing during pregnancy.~   "
109722|NCT01620060|"~     This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose~     study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum,~     autistic spectrum disorder, or other psychiatric disorders.~   "
109723|NCT01620047|"~     Major surgery involving the knee is often associated with severe postoperative pain.~     Postoperative pain control remains a significant contributor to delayed recovery and length~     of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of~     major concern due to the need for early mobilization, a crucial factor in good postoperative~     rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of~     anesthetics provide an effective method for analgesia while minimizing the need for systemic~     opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation.~     Administration of fentanyl has shown to be a highly effective method to control pain after~     Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will~     result in greater post-operative strength in the operative knee.~   "
109789|NCT01619189|"~     Transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human~     amniotic membrane with no feeders in eyes with total limbal deficiency. Prospective~     non-comparative monocentric study.~   "
110006|NCT01616355|"~     The present study tried to integrate all aspects of denture care: patient satisfaction with~     the treatment, denture decontamination and base material defects after decontamination~     processing.~   "
109724|NCT01620034|"~     Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally~     located lung tumours, offering very high rates of tumour eradication, with minimal side~     effects. Even though this treatment option is being adopted in more and more cancer centres,~     there is still no consensus about the optimal schedule for the radiation treatment.~     Generally speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At~     the Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation~     over 11 days (each treatment given once very 3rd day). However, some centres deliver the~     same treatment over 4 days in a row (each treatment given once daily over 4 days). There is~     no evidence from the published literature to suggest that there is any difference in side~     effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the~     investigators propose to conduct a comparative (randomized) study to compare these 2~     approaches.~   "
109725|NCT01620021|"~     Hypotheses:~      • A wearable sensor system can be used to accurately monitor three common gait parameters:~     gait speed, stride length, and torso motion.~      Objectives:~      This study will examine the feasibility of using wearable sensors to monitor common gait~     parameters: gait speed, stride length and torso motion. A wearable sensor system of 8~     commercially available inertial measurement units (IMU) will be composed. These sensors will~     work in unison to monitor the gait parameters.~      Technical Objectives~        -  Gather information on commercially available IMUs~        -  Use computer software to monitor and record data from IMUs~        -  Develop an algorithm that can monitor volunteer gait speed, stride length and torso~          motion~        -  Develop a graphical algorithm that compares healthy patient data to potential mild~          traumatic brain injury (mTBI ) candidates~        -  Determine if there is a potential for mTBI determination using the wearable sensors~        -  Accurately validate the wearable sensor system to the gait parameters measured using a~          Vicon motion analysis system~   "
109726|NCT01620008|"~     The purpose of this study is to determine if delaying cord clamping at the birth of term~     infants effects the early brain development (myelin deposition)as determined by quantitative~     MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will~     help to establish a scientific basis for the timing of cord clamping with reference to brain~     development.~   "
109727|NCT01619995|"~     The goal of this project is to evaluate the applicability of non-invasive optical imaging~     for the measurement of brain function during investigation of the lower urinary tract.~   "
109728|NCT01619982|"~     The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will~     decrease the rate of cefazolin non-susceptible SSI's, in high risk population 2) to develop~     better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing~     cardiopulmonary bypass 3) to assess the barriers to vancomycin dosing peri-operatively 4) to~     assess side effects and risks associated with peri-operative vancomycin administration. This~     will allow us to improve patient care by better understanding the benefits or the risks of~     peri-operative vancomycin administration and potentially decrease cefazolin-resistant~     surgical site infections.~      In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin~     pharmacokinetics on children on CPB.~      The investigators will take blood samples from 20 patients. In 10 patients the investigators~     will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin~     analysis. For the remainder of 292 patients, only prospective chart review will be done to~     determine the incidence of SSI's.~      This data will be compared with 936 controls who received only Cefazolin pre-operatively as~     prophylaxis for SSI's.~   "
109729|NCT01619969|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate~     the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with~     Confirmed Dengue Fever.~   "
109730|NCT01619956|"~     The osteotome sinus floor elevation (OSFE) technique has been proved to be a predictable~     procedure for successful implant placement in posterior maxillae with limited bone height~     under sinus. OSFE is considered to be minimal invasive and minimal traumatic while having a~     limitation with regard to the residual bone height. According to the consensus conference in~     1996, OSFE technique without bone grafting should be limited to RBH ranging from 7mm to 9mm.~     However, recent studies reported favorable results even with RBH of around 4mm. Moreover,~     there is still controversy regarding the necessity of a grafting material in order to~     maintain the space for new bone formation. Spontaneous bone formation was observed for OSFE~     without grafting by some researches.~      Due to the lack of randomized controlled trial (RCTs), there is still no clear guideline for~     implant therapy in posterior maxillae with limited bone height. Neither is there any~     evidence to recommend or contraindicate the application of grafting materials in combination~     with OSFE.~      The present RCT is aimed to evaluate the clinical success of OSFE with RBH of 2mm to 6 mm~     and to study whether the application of grafting material in combination with OSFE will be~     more favorable. The hypothesis is that the application of simultaneous grafting has no~     significant advantage in terms of clinical success. Spontaneous bone formation can be~     observed with implants placed using OSFE without grafting.~      90 systemically healthy adults consecutively admitted for oral implant therapy will be~     randomly assigned to 3 test groups. Only one implant system will be used to minimize the~     implant-originated influencing factors. Bio-Oss® will be chosen as the bone substitute as it~     is currently the typical xenograft available. Autogenous bone will be also used as it is~     deemed as 'gold standard' for bone graft materials.~      A panoramic radiograph and an intra-oral radiograph should be taken to assess the~     pretreatment bone height under sinus. For T1 group, the autogenous bone chips harvested~     during the drilling procedure will be mixed up with Bio-Oss®. And the mixture is placed into~     the 'socket' by osteotomes when elevating the sinus membrane until the final depth. For T2~     group, only Bio-Oss® will be placed into the 'socket' by osteotomes when elevating the sinus~     membrane until the final depth. No grafting materials will be used for T3 group. The~     subjects will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years and 3~     years after surgery for clinical and radiographic examination. Implant protrusion length,~     endo-sinus bone gain and crestal bone level will be measured on the radiographs using~     specialized software. ANOVA will be performed for the success rates of the 3 groups.~     Descriptive statistics will be used for the radiographic parameters.~      The present study is aimed to provide preliminary evidence for an important clinical~     question that whether OSFE is predictable and reliable with RBH of less than 6mm and whether~     the application of grafting materials is necessary for this indication.~   "
109731|NCT01619943|"~     The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to~     decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is~     to compare the clinical performance of these 2 decision rules for indentifying patients with~     intracranial traumatic lesions and those who required an emergent neurosurgical intervention~     following MHI.~   "
109732|NCT01619930|"~     The purpose of this study is to compare an internet-based behavioral activation program with~     a physical activation program, as treatments for mild to moderate depression. The added~     effect of rationale and motivational interviewing will also be studied, as well as the~     effects of relapse prevention program.~   "
109790|NCT01619176|"~     Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.~      The molecular bases of this recommendation are not known, the investigators want to compare~     with the usage of high-throughput molecular technologies the variations occurring in~     patients treated with acupuncture and conventional treatment with the ones treated with~     conventional treatment only. The investigators observe the variations in blood and in the~     gut microbiome.~   "
109733|NCT01619917|"~     While the literature tends to support the use of laser therapy in the management of burn~     scars, there is a definite lack of appropriately powered, randomized controlled trials.~     Laser therapy can be quite expensive when compared to other treatment modalities for burn~     scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For~     this reason, our assessing the effects of fractional vascular lasers on burn scars. It has~     been hypothesized that the fractional vascular lasers work on mature scars to decrease scar~     formation, and the fractional laser works on scar that is quiescent to promote remodelling.~     The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the~     mesh pattern created by meshed split thickness skin graft).~      Objective:~      To determine the benefit of fractional vascular laser treatment in improving burn scar~     height, texture, vascularity and pliability in late burn scars.~   "
109734|NCT01619904|"~     A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes~     Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is~     done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft~     survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per~     year.~      Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the~     post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic~     benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There~     are a number of studies showing significantly improved biochemical markers of inflammation~     in animal models and in studies on septic patients (patients with an overwhelming infection)~     following GDT. Studies have also shown that GDT improves clinical outcome in post-operative~     patients and in serum inflammatory mediators. These studies have looked at major abdominal~     surgery but none have investigated transplant patients. Given the nature of surgery we feel~     that our patients would benefit with reduced Intensive Care Unit stay, reduced length of~     hospital stays and reduced rates of post-operative complications.~      The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It~     will last for 2 years and we hope to recruit 60 patients~      Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current~     practice. Each intervention will last for six hours post-operatively before continuing with~     normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively~     and blood samples will be taken from patients at regular intervals for 72 hours intra- and~     post- operatively. Patients will be followed up daily while an in-patient and at~     three-monthly intervals in out-patients for 1 year.~   "
109735|NCT01619891|"~     Despite recent advances and even when receiving optimal therapy, patients with chronic heart~     failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent~     symptoms. The investigators have shown that patients attending the Leeds Integrated Heart~     Failure Service are also frequently deficient in vitamin D and that the severity of the~     deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and~     response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle~     contractile function, immune function, pancreatic insulin release, and neuro-hormonal~     homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has~     demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a~     randomised, placebo-controlled developmental clinical study in 250 patients with CHF and~     vitamin D deficiency. The present study is designed to detect whether vitamin D has~     pathophysiologically important effects, as well as providing preliminary evidence of~     efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging)~     and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data~     to inform a larger multi-centre efficacy and effectiveness study.~   "
109736|NCT01619878|"~     The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data~     following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of~     body weight (BW) with uncomplicated falciparum malaria.~   "
109737|NCT01619865|"~     This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging,~     and measurement of response to treatment in patients with somatostatin receptor positive~     tumors. We will 1) compare this unique PET/CT scan with the current standard of care which~     is a combination of Octreoscan SPECT (single photon emission tomography) plus a high~     resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in~     diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those~     patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such~     as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure~     response to treatment. These studies will be obtained with the long term goal of submitting~     a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.~   "
109738|NCT01619852|"~     The study seeks to investigate a safe and inexpensive strategy to reduce persistent~     post-surgical pain that can affect up to 60% of patients undergoing surgical procedures. It~     also seeks to investigate specific brain changes associated with the development of chronic~     pain. This may lead to the development of more specific and more effective treatments.~      Hypotheses:~        1. Perioperative systemic lidocaine reduces the incidence of chronic pain in patients~          undergoing surgical procedures.~        2. There is a specific brain morphological/function change associated with the development~          of chronic pain.~   "
109739|NCT01619839|"~     NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe~     chronic pain - active as a mu agonist, but with inherent molecular properties designed to~     provide a unique clinical profile, including most notably, reduced CNS side effects and an~     attenuated attractiveness as a target of abuse.~   "
109740|NCT01619826|"~     The objective of this study is to use a randomized controlled design to determine whether~     cardiorespiratory fitness training improves neurocognitive function and academic performance~     during preadolescent development.~   "
109741|NCT01619813|"~     The purpose of this study is to find out if giving Reolysin in combination with docetaxel~     and prednisone can offer better results than standard therapy with docetaxel and prednisone.~   "
109742|NCT01619800|"~     The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker~     sensor which responds only by comparing physical activity, heart rate, and breathing rate;~     compared to the accelerometer pacemaker sensor which respond only by comparing physical~     activity and the heart rate in patients whose heart is unable increase its heart rate~     according to increase physical activity or demand (Chronotropic Incompetence). Only one~     pacemaker family will be used in this clinical trial whereas the out of box configuration~     is the blended sensor which can also be made to act only as an accelerometer.~   "
109743|NCT01619787|"~     The goal of the proposed study is to apply experimental economics in an online grocery store~     shopping model to examine the effects of pricing on hypothetical food purchases~   "
109745|NCT01619761|"~     The goal of this clinical research study is to learn if giving cells called natural killer~     (NK) cells after receiving fludarabine, melphalan, lenalidomide, and a UCB transplant can~     improve response in patients with leukemia, lymphoma, or MM. The safety of this treatment~     and whether NK cells can lessen the risk of graft vs. host disease (GVHD) will also be~     studied.~      Patients with a disease that is CD20-positive will also receive rituximab on this study.~      The first 3 patients enrolled on this study will not receive NK cells but will receive a~     cord blood transplant.~      UCB and NK cells may be able to kill leukemia, lymphoma, or myeloma cells that remain in~     your body after chemotherapy treatment.~      The UCB cells are also designed to increase blood production and strengthen your immune~     system.~   "
109746|NCT01619748|"~     Peripheral vascular function is impaired in people with obstructive sleep apnoea who are~     untreated compared with age-, weight- and sex-matched healthy controls.~   "
109747|NCT01619735|"~     The purpose of this study is to evaluate outcomes of an established procedure for treatment~     of kidney stones that are present within the inner aspect of the kidney. This procedure is~     called flexible ureteroscopy, which involves placing a small camera through the urethra~     while anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into~     the kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small~     laser called a Holmium laser. While this treatment is a well-established option for~     treatment of these stones, there are several different techniques used to help eliminate~     them from the kidney. Some urologists treat the stone by a method called active extraction~     whereby the ureteroscope is passed back and forth into the kidney to remove all visible~     stone fragments. Others use a method called dusting whereby the stones are broken into~     tiny fragments or dust with the intention that achieving such a small stone size will~     allow the stones to pass spontaneously. There has not been a systematic and rigorous~     comparison of these techniques in terms of treatment outcomes. By collecting information on~     the success of treatment, the investigators hope to provide benchmark data for future~     studies of kidney stone treatment and improve the care of all patients who need surgery for~     their kidney stones.~      The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around~     90% and that the stone clearance rate with be 20% higher in those patients that undergo~     complete stone fragment extraction versus those that undergo stone dusting (residual~     fragments < 2mm).~   "
109748|NCT01619722|"~     Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease~     (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in~     France, because it is treatable by a diet low in phenylalanine. This plan is required upon~     confirmation of diagnosis and continued until the age of 8 years. The current trend is to~     continue the scheme at least until adolescence. Unlike other countries, in France there are~     no recommendations for a plan for life. Knowledge about the natural history of PKU in~     adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic~     factors are poorly documented. On the other hand, there is no consensus on the therapeutic~     management of this disease in adulthood and monitoring that could be directed towards the~     detection of neurological disorders and nutrition. Social integration and quality of life of~     adults PKU patients living in France have not been studied.~   "
109749|NCT01619709|"~     To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic~     intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related~     hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral~     Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep~     hemorrhage (probably related to hypertension).~   "
109750|NCT01619696|"~     The objective of the present project is to validate the feasibility of a multimodal~     radiological pathway while on chemoradiotherapy, in order to validate potentially predictive~     factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.~   "
109751|NCT01619683|"~     To determine the effects of 12 months of treatment with Androxal on bone mineral density in~     men with secondary hypogonadism.~   "
109752|NCT01619670|"~     Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the~     patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically~     determined skin fragility disorders characterized by blistering of the skin and mucosae~     following mild mechanical trauma. There is no specific proven treatment for any form of EB,~     and the mainstay of clinical management is based on protection and avoidance of provoking~     factors. Chronic nonhealing erosions and ulcers have been treated with conventional~     split-thickness skin grafts. Alternatively some patients may benefit from the use of~     autologous or allogeneic cultured keratinocyte grafts.~   "
109753|NCT01619657|"~     The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and~     effective preventive therapy in newborns and infants with cystic fibrosis (CF).~   "
109754|NCT01619644|"~     An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized~     to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or~     by placebo for one year.~      The investigator would like to include children because they could best profit from it due~     to their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic~     plasticity.~      The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a~     clinical approach (learning and memory neuropsychological evaluation, fine motor skills~     assessment by pointing), to a biological approach (histone acetylation functional tests),~     and to imaging (morphological and functional MRI).~   "
109755|NCT01619631|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) that~     provides the feasibility, safety, and preliminary efficacy data required to design a large~     scale trial evaluating Tai Chi for Chinese Americans with major depressive disorder (MDD)~     who are not on antidepressant medications.~   "
109756|NCT01619618|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This laboratory study is looking at biomarkers in samples from patients with~     recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.~   "
109757|NCT01619605|"~     The purpose of this study was to investigate the utility of serum tryptase for the~     confirmation of shrimp-induced anaphylaxis.~   "
109758|NCT01619592|"~     Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an~     insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients~     will be recruited during the conventional consult. If they want to participate, they will~     get detailed information regarding the study; after giving consent; they will sign the~     informed consent form and they will get a unique study number.~      The patient will than complete a questionnaire on a secured website (https://) using the~     unique study number. After completing this questionnaire, the patient will be randomised~     either into a group 'standard care + direct start with web-based diabetes education'~     (intervention group) or they will enter into the other group (control) receiving standard~     care. Three months after the start of the study, all patients will be asked to complete the~     questionnaire again and the patients into the control group will also get access to~     'standard care + web-based diabetes education'. The questionnaire will have to be completed~     on months 6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be~     determined. This is part of the routine examination in each participating hospital (UZGent~     and AZ Nikolaas). The determination of HbA1c is not study-specific but the value will be~     taken into the study.~      The web-based questionnaire:~      Patients will enter on a website including general study-information. They also have to~     explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared~     to participate in the study' they will see a second webpage retrieving some general~     information. After receiving this real basic information; they will be redirected to a~     secure website (https://) and will make use of a unique study number. Only the main~     researcher will have the possibility to link the general information to the unique study~     number.~      The informed consent form:~      The patient will be asked for added information. He/she will have to sign specific pages~     giving explicitly informed consent for information retrieved from the 'mutualiteit'~     (National Health Service - NHS).~      On the NHS information will be asked regarding the health costs. These figures should make~     it possible to have a more objective figure of the costs associated to diabetes (care).~      The patient can stop on every moment the study participation. Once decided he/she wants to~     stop, he/she will receive standard care.~      Study hypotheses: the QoL will improve by the use of web-based diabetes education; there~     will be a reduction in costs using web-based diabetes education; there will be at least an~     equal-stay or improvement of the HbA1c while using web-based diabetes education.~   "
109759|NCT01619579|"~     Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved~     Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and~     psychological assessment. This non-invasive device is able to rapidly raise the core body~     temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating~     element. The change in body temperature may change the sympathetic nervous system's activity~     and thereby reduce Fibromyalgia pain.~   "
109760|NCT01619566|"~     Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber~     characteristics. This can be used to predict which future patients will respond to~     Duloxetine.~   "
109761|NCT01619553|"~     Keloids have a strong genetic component. The goal of this study is to identify genes and~     regulatory elements on chromosomes that are the cause for keloids or contribute to keloid~     scarring.~   "
109762|NCT01619540|"~     Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic~     obstructive pulmonary disease (AECOPD).~      This association is frequently underestimated with regard to the difficulty of clinical~     diagnosis .~      The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.~   "
109763|NCT01619527|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence~     of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg~     tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under~     fed and fasted conditions) in healthy participants.~   "
109764|NCT01619514|"~     The purpose of this study is to evaluate the use of advanced quantitative mass spectometry~     (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to~     compare the protein profile between different subtypes of breast cancer (ER positive, HER2~     positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from~     the NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2~     positive, and triple negative tumors. Samples will be analyzed using advanced Mass~     Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that~     may be important in cancer. DNA and RNA will also be extracted from tumor samples for~     correlative analysis with the proteomics data. Genomics and proteomics data will be~     correlated with clinical data including treatment response and survival data. Importance of~     proposed research to science or medicine:Identification of tumor biomarkers may allow better~     prognostication, follow-up, and selection of treatment for cancer patients in the future.~     Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is~     minimal as there is no direct patient contact, and analysis is done on previously donated~     tumor samples. Patients have previously provided consent to donate their samples for~     research into the NUHS Tissue Repository.~      Novel tumor biomarkers that determine tumor biology, including prognosis and treatment~     sensitivity, may be detectable using the novel advanced quantitative mass spectromy method~     (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles~     analyzed using super SILAC.~   "
109765|NCT01619501|"~     The overall goal of this research is to enhance the investigators understanding of the~     pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets.~     By comparing gene expression between normal lung tissue and tumors growing in lung-specific~     C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being~     abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have~     validated this observation in human lung cancer, implicating the investigators KO mice are~     an effective discovery tool for lung cancer research. Through similar approaches, the~     investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other~     pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators~     will proceed to define the clinical relevance of the SHH pathway and the other~     newly-discovered molecular aberrations, by analyzing their expression and correlate it to~     C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators~     preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful~     correlates that could be used in diagnosis and treatment of lung cancer, as well as identify~     new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may~     behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.~      This proposal seeks to test the hypothesis that pathways which are dysregulated in lung~     tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to~     identify genes involved in human lung cancer pathogenesis.~   "
109766|NCT01619488|"~     This study is to determine if the Lap-band system is safe and effective for use in morbidly~     obese adolescents.~   "
109799|NCT01619059|"~     The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple~     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes~     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of~     this treatment will also be studied.~   "
109800|NCT01619046|"~     The purpose of this study is to assess the safety, efficacy and pharmacokinetics of~     GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days)~     with a Factor VIII concentrate and without presence or history of inhibitors to FVIII~     (Factor VIII).~   "
109767|NCT01619475|"~     The study is being conducted for the following reasons:~        1. To determine the prevalence, course, and predictors of poor Health Related Quality of~          Life (HRQOL) outcomes associated with living donor donation.~        2. To collect data and biosamples prior to, during, and after a living donor liver~          transplant (LDLT) among all donors and recipients for use by other adult-to-adult~          living donor liver transplant studies and future studies.~        3. To study the effects of pressure and flow on the outcomes of LDLT.~        4. To characterize the differences between living donor liver transplant and deceased~          donor liver transplant in terms of recipient post-transplant outcomes including patient~          and graft survival, surgical morbidity, and resource utilization.~        5. To compare the long-term histological outcomes in recipients of LDLT and deceased donor~          liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.~        6. To understand the history of pain management and to measure quality of care in pain~          control in living donors following partial hepatectomy.~   "
109768|NCT01619462|"~     The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent~     pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New~     Guinean children, who experience early dense upper respiratory tract colonisation with a~     broad range of pneumococcal serotypes, and to compare antibody titres following a booster~     dose of polysaccharide vaccine at 9 months with those children who received no booster at~     the same age.~   "
109769|NCT01619449|"~     To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic~     liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters.~     The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is~     associated with increased solute removal and improved acid-base statues when compared to~     controls who do not receive CRRT~   "
109770|NCT01619436|"~     The purpose of this study is the randomized blind research of the assessment of the~     different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary~     by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response~     during cardiac surgery, the investigators would like to know if the glycemia levels in~     clondine group will be lower than placebo group.~   "
109771|NCT01619423|"~     The present trial is designed to determine whether pre-treatment with PledOx lowers the~     frequency and severity of side effects from FOLFOX6 administration in patients with~     metastatic colorectal cancer.~      The efficacy of two different doses of PledOx will be assessed when added to FOLFOX6~     chemotherapy as first line treatment of metastatic colorectal cancer.~   "
109772|NCT01619410|"~     In this pilot study, the objective is to determine the prevalence of asymptomatic carriage~     of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with~     either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the~     investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy~     of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus~     isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient~     population before and after therapy. Given the results of a recent study on linezolid and~     vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA~     carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous~     abscesses than it is with oral clindamycin.~   "
109773|NCT01619397|"~     This Clinical Investigation is designed to provide tolerance, acceptability and safety data~     of a new condom coating, in its intended use to support future application for CE Mark.~   "
109774|NCT01619384|"~     This proposed study aims to determine whether decreasing stress levels in persons with~     posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota,~     assessed 8 weeks after enrollment.~   "
109775|NCT01619371|"~     The purpose of this study is to analyze the effectiveness of an FDA approved Class II~     medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of~     engorgement.~   "
109776|NCT01619358|"~     Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion~     of plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and~     genetic heterogeneity of the disease have been dissected. With the maturation of~     technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify~     and prognosticate myeloma in the clinical setting and use this information to guide current~     treatment. The investigators hypothesize that the use of gene expression profiling as a~     single test will be more economical, efficient and accurate compared to the current standard~     panel of tests done at diagnosis. The investigators also hypothesize that the investigator~     can use predictive markers to identify prospectively patients who will respond to Velcade~     and that with more effective trebasedonatment, ability to measure depth of response beyond~     conventional complete response become important since more patients are achieving~     conventionally determined complete response. Using a cohort of patients treated on a~     standard treatment protocol based on Velcade-based induction treatment followed by~     consolidation and maintenance treatment, the investigators will study specifically the~     feasibility and accuracy of gene expression diagnostics, the predictive power of the~     investigators predefined predictive markers and the clinical utility of minimal residual~     disease measurement in myeloma. The results of the investigators study will allow us to~     improve the diagnosis, and prognostication of MM patients~        1. The investigators hypothesized that this will speed up diagnosis, provide comprehensive~          information for the classification and risk stratification of MM patients and can~          completely replace the current FISH assay and may be cheaper.~        2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will~          identify patients that will have a significantly better response to Velcade.~        3. Modern treatment induced deeper response. More sensitive method of disease detection~          will allow us to know the fully extent of response to these treatment~   "
109777|NCT01619345|"~     This trial is conducted in Europe. The aim of this trial is to investigate whether the~     volume of water administered with NN9924 affects the anatomical location (stomach or~     proximal small bowel) of tablet erosion.~   "
109778|NCT01619332|"~     This study is a three part study to assess the safety and efficacy of LEZ763 on normal~     healthy volunteers and patients with Type 2 Diabetes.~   "
109801|NCT01619033|"~     This is an open, parallel group study in subjects with normal renal function compared to~     those with renal dysfunction.~   "
109877|NCT01618045|"~     Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the~     counter. FPP possesses antioxidant properties, which provide benefit against age-related~     complications, and is also known to protect red blood cells (RBCs) against oxidative damage~     and to help protect against severe forms of thalassemia. The investigators recently showed~     that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic~     peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these~     observations, the investigators propose to study the outcome that FPP supplementation has in~     patients with diabetes.~   "
114215|NCT01561196|"~     The aim of the project is to compare two methods for arterial cannulation. The traditional~     method with ultrasound guided cannulation. The investigators goal is to improve this~     procedure to reduce pain and complications.~   "
109779|NCT01619319|"~     Onset of psychotic disorders such as schizophrenia, typically occurs during late adolescence~     or early adulthood often resulting in chronic social and occupational disability. Deficits~     in cognition and functional outcome often precede the onset of full-blown psychosis although~     to a lesser degree than observed in schizophrenia. Recent progress in risk identification~     methodology has enabled reliable detection of persons who appear to be putatively prodromal~     for psychosis, that is, at clinical high risk (CHR) of developing a psychotic disorder.~     Since these CHR individuals already evidence cognitive deficits, which increase around the~     time of conversion, cognition is an excellent treatment target. Furthermore, there is clear~     evidence, in schizophrenia and in CHR samples, that deficits in cognition are related to~     poor functional outcome. Thus, treatments targeting cognition may consequently improve~     functional outcome. The primary aim of the project is to reduce cognitive deterioration and~     improve cognition among youths at CHR using cognitive remediation and to test the~     effectiveness of a new cognitive remediation program, the Brain Fitness program, in~     improving cognition of CHR individuals. A control treatment consisting of video games (VG)~     will be used. The primary hypothesis is that the BF group will have improved cognition at~     the end of treatment and 12 months post baseline compared to the VG group. A secondary~     hypothesis is that improved cognition will be associated with improved functioning. This is~     a longitudinal, single blind, placebo controlled pilot trial of cognitive remediation in 36~     CHR persons. Participants will be randomised to either the BF or VG program, which will be~     administered over a period of 3 months. Assessments will occur at baseline, post treatment~     (3 months) and at 12 months after baseline. All subjects will be recruited in year 1 of the~     project and treatment will be completed by 15 months. The 40 hours of training will occur 4~     days a week, for an hour each day, over a period of 10 -12 weeks.~   "
109780|NCT01619306|"~     Objectives:~      Primary objectives:~      • The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary~     institution, to assess whether breast cancer patients and their physicians would consider~     the use of three different kinds of genetic tests currently available to breast cancer~     patients:~        -  BRCA1/2 germline testing,~        -  CYP2D6 genotyping and~        -  Oncotype DX® testing.~      Secondary objectives:~      To explore factors which might influence their decisions on genetic testing, including:~        1. Acceptability of the tests and anti-cancer management based on the test results~        2. Reliability and affordability of the test~        3. Ability of the test to influence treatment decisions~        4. Broader implications of the test, e.g., psychosocial, financial impact Study design:~          Cross-sectional study, Survey Questionnaires were developed for 3 categories of~          individuals:~             -  Patients with early stage breast cancer~             -  Healthcare professionals caring for breast cancer patients~             -  Medical students /cancer researchers The questionnaires for patients and medical~               students/cancer researchers are similar. The questionnaires contain a brief~               section on demographic information, interest in and past experience with genetic~               testing. Three hypothetical situations are described to determine if participants~               will agree to BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing,~               respectively. 18 categorical 'yes'/ 'no' questions explore reasons for their~               decisions. Each scenario requires a short, hand-written response.~      The questionnaire for healthcare professionals contains a brief section on demographics and~     past experience with genetic testing. Three hypothetical situations are described to~     determine if healthcare professionals will recommend their patients for BRCA1/2 testing,~     CYP2D6 genotyping and Oncotype DX® testing, respectively. 12 categorical questions explore~     the reasons for their decision, and physicians are required to rank these in order of~     importance.~      Distribution of questionnaires:~      Questionnaires will be handed out to agreeable participants on the following occasions:~        1. Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas~        2. Medical students - before or after lectures, or at personal contact~        3. Cancer researchers - before or after lectures, or at personal contact~        4. Healthcare professionals - before or after NUHS breast tumour board, or at personal~          contact Due caution will be exercised to ensure that the questionnaire is only handed~          out to subjects who are aged 21 years and above.~      No subject identity will be collected for these questionnaires.~      Rationale and Hypothesis:~      BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing have all been approved~     for use in clinical practice, but controversy still exists surrounding their utility, and~     apart from BRCA1/2 mutation testing in high-risk individuals, genetic tests are not~     routinely performed in Singapore. BRCA1/2 germline mutation testing is performed in~     individuals at high risk for hereditary cancer. CYP2D6 genotype testing predicts the benefit~     of adjuvant tamoxifen therapy; poor and intermediate metabolisers of tamoxifen may have a~     higher risk of breast cancer recurrence due to lower efficacy of tamoxifen because of less~     efficient conversion of tamoxifen to endoxifen, the active metabolite of tamoxifen. Oncotype~     DX® testing is a gene-expression profiling test performed on a formalin-fixed paraffin~     embedded tumour specimen, to predict the risk of breast cancer recurrence and guide~     decisions on adjuvant chemotherapy. Understanding the attitudes of patients and medical~     professionals toward these genetic tests may help to guide medical oncologists in their~     clinical recommendations and utilization of these tests in breast cancer patients.~   "
109781|NCT01619293|"~     Abstract:~      The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone~     specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict~     neuronal damage caused by traumatic brain injury. The investigators conduct a study to~     derive and validate the measurement of S-100B in serum of patients with different types~     traumatic brain injuries.~   "
109782|NCT01619280|"~     Acute lung injury (ALI) is caused by a wide variety of conditions, but always characterized~     by hypoxia and non-cardiogenic pulmonary edema. Current treatment of ALI is supportive and~     treatment of the underlying cause. New therapies to treat severe ALI have not been shown to~     improve survival, and are limited by financial and logistical resources.~      The investigators propose to investigate the role of inhaled sodium nitroprusside (iSNP) in~     ALI. Sodium nitroprusside (SNP) is a vasodilator. When inhaled, SNP may travel to areas of~     the lung participating in gas exchange, and cause the blood vessels surrounding these areas~     to enlarge. This may result in an increase of blood vessels to these areas of the lung, and~     improve oxygenation. Currently, iSNP has not been studied in the adult population.~     Therefore, this study is intended to find the safety profile of varying doses of iSNP.~   "
109783|NCT01619267|"~     Infections related to implantable pacemakers or cardioverters defibrillators are sometimes~     difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of~     standard markers of inflammation such as C-reactive protein or white blood cell count and~     the diagnosis is mainly based on the clinical presentation. The observational DIRT-study~     evaluates if new biomarkers may be more suitable to support a diagnosis of device associated~     infections than the currently available ones.~   "
109784|NCT01619254|"~     Impact exerted by intestinal parasitic infections is much higher in developing countries.~     School-aged children are at higher risk from the burden of disease, because they specially~     have many parasitic infections. The poor health results in deficits in physical and~     cognitive development and educational achievements. Nowadays, there is huge commitment among~     the global community to control intestinal parasitic infections and to improve nutritional~     status of young children in developing countries.~      Large-scale anthelminthic drug administration through vertical control programmes is still~     required for the foreseeable future and is, therefore, recommended by the World Health~     Organization (WHO). However, due to the inevitability of re-infection in endemic areas,~     children need to be treated regularly, and once morbidity control is consolidated, the~     strategy must shift to transmission control emphasising access to clean water and adequate~     sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from~     the onset of control activities, complementary measures should be implemented, that depend~     on available resources.~      Therefore, the investigators are proposing to undertake a randomised controlled trial to~     assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing~     with soap and hand finger nail clipping) on intestinal parasitic infection prevalence,~     intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence~     rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and~     how hand hygiene practice affects infection prevalence and re-infection rates, as well as,~     anaemia prevalence among the highly vulnerable age group.~   "
109785|NCT01619241|"~     The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which~     patients will have poorer progression free survival and overall survival in advanced~     Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more~     aggressive treatment.~   "
109786|NCT01619228|"~     The skin barrier lipids will be lower in premature infants than in full term infants and~     will become normal over 3-4 months after birth. The higher skin pH in premature infants will~     be related to an altered lipid composition which will change as the skin acidifies.~   "
109787|NCT01619215|"~     Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease.~     In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide~     spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple~     hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later~     fibrosis, cirrhosis, and eventually some patients may develop hepatocellular carcinoma with~     or without cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an~     active area for research. The diagnosis of NAFLD is achieved through histological~     examination of liver biopsies (invasive), non-invasive markers using serum biomarkers and~     imaging techniques are still under development. Pathological diagnosis can be then~     subcategorized based on several scoring systems. More widely used are the Brunt Score or NAS~     (NAFLD activity score) and the Kleiner's modified NAS.~      Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more~     prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by~     the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either~     β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an~     additional source of fat in the liver. Due to the strong association of NAFLD with obesity,~     weight reduction procedures are used for the management of NAFLD. In fact, this has been~     shown to be effective by several studies. However, other studies have reported liver~     deterioration after bariatric intervention. This conflict is what makes the effects of~     bariatric procedures a challenging field for further studies. Consequently in this study we~     are aimed to examine histologic, metabolic and liver function changes induced by the~     different therapeutic bariatric procedures.~   "
109788|NCT01619202|"~     The purpose of this study is to examine differences in driving performance on a simulated~     driving assessment between novice teen drivers who receive the Risk Anticipation-Perception~     Training (RAPT) program and novice teen drivers who do not receive the training program.~   "
109791|NCT01619163|"~     Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of~     arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the~     leading symptom and is often chronic in nature leading to significant morbidity and~     decreased quality of life. Synovitis is prevalent in knee OA and treatment to relieve this~     synovitis may reduce pain.~      Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess~     whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic~     low-grade inflammation, in the short term and to determine if it sustained long term at 12~     weeks in older adults with moderate to severe knee OA.~      Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA~     diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will~     berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive~     placebo together with their usual therapy for 6 weeks. The primary outcome measure will be~     pain reduction. Secondary outcome measures will be reduction in systemic inflammation and~     improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs~     used will be recorded. Safety and tolerability were also assessed. Data will be collected at~     baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at~     6 weeks. Exclusion criteria will include any inflammatory or serious medical condition.~      Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale.~     Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional~     Index (LFI)score > 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS,~     0-100), self-reported physical function as measured with the Western Ontario and McMaster~     Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute~     walk distance (6MWD). All patients will undergo a physical examination and will be~     questioned about the number of flares, pain and analgesic use. Blood samples will be~     collected and serum levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all~     patients.~   "
109792|NCT01619150|"~     The purpose of this study is to investigate which pain mechanisms that can be affected by~     etoricoxib compared to placebo (inactive medication)in subjects with painful knee~     osteoarthritis af 4 weeks of treatment.~   "
109793|NCT01619137|"~     Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin~     treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)~   "
109794|NCT01619124|"~     Nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia~     (ALL) or lymphoblastic lymphoma (LBL) can be cured and become long-term survivors. Avascular~     osteonecroses (ON) appear as serious side-effect of antileukaemic treatment. Frequently ON~     are first diagnosed at higher and than irreversible stages (ARCO III, IV). At these advanced~     stages curative treatment options are not available. Hence ON are associated with~     considerable morbidity concerning pain and immobility and go along with long-term impairment~     of quality of life. Therefore early diagnosis of ON in the follow-up of children and young~     adults with ALL or LBL is a pressing object.~      Within the prospective multicentric observational OPAL-trial patients at risk (aged 10 years~     or older) treated according to the clinical trials ALL-BFM(Berlin-Frankfurt-Muenster Study~     Group), COALL or NHL (Non Hodgkin Lymphoma)-BFM in Germany should be examined with regard to~     the development of ON. By using a treatment associated, risk orientated assessment and~     examination incidence, symptoms and the clinical course of ON are investigated. The validity~     of MRI screening in the early diagnosis of ON in children and young adults is analysed.~      Systematical investigation of patients under antileukaemic treatment is intended to~     contribute to risk adapted diagnostic strategies and to serve as data base for the~     subsequent evaluation of preventive and interventional approaches for the treatment of ON.~     Long-term objective is the reduction of ON-associated morbidity.~   "
109795|NCT01619111|"~     The HER2 status in breast cancer patients may change during the course of the disease. In~     30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive~     CTCs can be detected in peripheral blood samples(1). At present, it is unclear if therapy~     based on the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III~     - trial compares lapatinib, as HER2-targeted therapy in combination with standard therapy~     versus standard therapy alone in those patients, with initially HER2-negative metastatic~     breast cancer and HER2-positive circulating tumor cells.~      As one of the first interventional trials based on the assessment of CTC phenotypes, the~     DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with~     MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker~     for treatment response.~   "
109796|NCT01619098|"~     Hospital readmissions are common, costly, and potentially preventable. They are also~     potentially responsive to health system interventions. However, it is uncertain which~     components of care transition interventions are efficacious, for which populations, and at~     what cost. This randomized controlled study is part of a larger project that will evaluate a~     three-tiered quality improvement (QI) intervention intended to reduce hospital readmissions~     within 30 days post-discharge from an urban safety net hospital that serves a racially and~     linguistically diverse population (the randomized controlled study evaluates Tier 3). Few~     studies have evaluated care transition interventions to reduce readmissions among~     low-income, diverse patient populations, and the accumulated evidence on the effects of~     these multi-faceted interventions on readmission rates has been inconclusive. This project~     will take advantage of a unique sequence of three QI innovations to reduce hospital~     readmissions implemented beginning in 2007 in an integrated safety net health care system.~     The discharge-transfer tiers are as follows: 1) Tier 1 includes a comprehensive,~     individualized home care plan (HCP) reviewed by the medical service floor nurse with the~     patient prior to discharge; 2) Tier 2 adds the electronic transmission of the HCP to the~     patient's primary care medical home where, on the business day following discharge, a~     Registered Nurse makes an outreach telephone call to the discharged patient to confirm~     comprehension of the HCP and to address medical questions or needs; 3) Tier 3 further adds a~     community health worker, the Patient Navigator, to participate in bedside discussions to~     develop rapport and learn about patients' home situations, weekly outreach calls to assess~     patients' needs and to facilitate communication between the patient and the primary care~     team, and reminder calls to patients prior to all medical appointments to eliminate barriers~     to outpatient follow-up. The Aim of the study being registered is to evaluate the effects of~     an ongoing randomized natural experiment on readmissions, health care use, adherence to~     medication instructions, and preparedness for discharge. This natural experiment features~     random assignment to one of two QI interventions, Tier 2 or Tier 3, and exclusively targets~     patients at high risk for readmission, those with one or more of the following risk factors~     for readmission: discharge diagnosis of congestive heart failure or COPD; length of stay > 3~     days; age > 60; or previous hospitalization within the past six months.~      The investigators hypothesize that the Patient Navigator intervention (Tier 3) compared to~     usual care (Tier 2) will increase the rates of 30-day post-discharge PCP visits; reduce~     30-day hospital readmission rates; and reduce the total number of days in hospital in the~     180 days following the index admission for high risk patients. The investigators further~     expect that the PN intervention will improve patient adherence to medication instructions in~     the HCP and reduce the probability of reported problems with post-discharge care.~   "
109797|NCT01619085|"~     The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in~     patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the~     follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and~     1199.34), who wish to continue treatment with BIBF 1120.~   "
109798|NCT01619072|"~     This randomized controlled community-based trial will assess the effectiveness of~     administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with~     standard of care for postpartum hemorrhage treatment at the community level, primarily home~     births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar~     districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this~     setting is referral to a higher level health facility.~   "
114216|NCT01561183|"~     To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement~     for management of human dental pulp with irreversible pulpitis.~   "
109802|NCT01619020|"~     Colorectal (CRC) cancer is the third most common cancer in the United States and its~     incidence is rising in younger populations. Diet seems to affect risk for CRC.~      Many parts of our diet are processed and modified by the microbes or bacteria in our gut.~     There are many different types of bacteria in our gut, each one of us has a community of~     different types and amounts of each type.~      When we eat flaxseeds, certain types of bacteria will process them - producing compounds~     that can then affect our body. How much of these compounds are produced by each person~     depends on the community of bacteria in the gut.~      Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut~     bacteria can convert the lignans into biologically active compounds that in animal models~     prevent the development of colon cancer. The investigators will study how these biologically~     active compounds affect colon cell-signaling pathways important to colorectal cancer risk.~      Results from our study will bridge the current knowledge from animal studies and~     epidemiologic studies and may help to inform approaches for future CRC prevention.~   "
109803|NCT01619007|"~     Following the findings of the clinical trials in drug development, this global~     non-interventional cohort field study will investigate rivaroxaban under clinical practice~     conditions in comparison with current standard of care for patients with acute deep vein~     thrombosis (DVT).~      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of~     acute DVT in routine clinical practice.~   "
109804|NCT01618994|"~     A study to determine whether completing a rigorous simulation protocol could provide novice~     robotic surgeons with actual advanced surgical skills in an operating room setting.~   "
109805|NCT01618981|"~     The purpose of this study is to assess left atrial pacing therapy in patients with atrial~     dyssynchrony syndrome and heart failure with preserved ejection fraction.~   "
109806|NCT01618968|"~     Relative Bioavailability Comparison study~   "
109807|NCT01618955|"~     The purpose of this study is to assess the usability of the VIBEX MTX device for SC~     self-injection of methotrexate.~   "
109808|NCT01618942|"~     This study was conducted to explore the influencing factors, subjects and testers'~     evaluation about pain measurement with hand-held pressure algometer with different size~     probes. Methods:100 healthy undergraduate students(50 males and 50 females) were recruited~     into this study. Pain measurement including pressure pain threshold (PPT) and pressure pain~     tolerance(PTO) was carried out by the hand-held pressure algometer with different size~     probes (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We~     recorded subjects' skinfold thickness, time per test procedure, types of pain perception,~     receptivity and degree of accuracy as well as testers' level of laborious.~   "
109809|NCT01618929|"~     -  To search the effects of montelukast on the airway inflammation including FEV1%,~          FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge~          tests, the leukotriene levels in the exhaled breath condensate in asthmatic children~          with and without food allergy aged 6-18 years old.~        -  To define the patient groups with good response to montelukast and to define the~          parameters which predict the good response.~   "
109810|NCT01618916|"~     This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.~     Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body~     handles the drug, and the drug's effect on the body will be evaluated. Participants will~     participate in the study for approximately 3 months not including screening. Screening is~     required within 42 days prior to the start of the study.~   "
109811|NCT01618903|"~     The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg~     intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy~     volunteers.~   "
109812|NCT01618890|"~     Study hypothesis:~      Hepatic venous pressure gradient (HVPG)-directed primary prophylaxis with nonselective~     beta-blocker therapy (NSBB) leads to a reduction in first variceal bleeding episodes and is~     cost-effective in the long term.~      Study design:~      A multi-center randomized controlled study comparing nonselective beta-blocker therapy~     guided by the hemodynamic response as determined by the difference in HVPG before and after~     starting oral NSBB therapy, to standard heart rate-guided NSBB therapy in patients with~     esophageal varices due to liver cirrhosis without a history of esophageal variceal~     hemorrhage.~      Primary study parameters/outcome of the study:~      First variceal bleeding episodes occurring within the first two years.~      Secondary study parameters/outcome of the study:~        -  Mortality~        -  Occurrence of other cirrhosis-related complications~        -  Occurrence of hepatocellular carcinoma~        -  Costs of treatments~        -  Adverse effects~   "
109813|NCT01618877|"~     The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg~     intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.~   "
109814|NCT01618864|"~     This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in~     wrinkle and rosacea treatment.~      Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then~     twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the~     clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.~   "
109815|NCT01618851|"~     This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT~     with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will~     be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy~     in 25 fractions).~   "
109841|NCT01618513|"~     Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily~     used after insufficient surgical intervention, but also as primary medical treatment in~     selected patients. Evaluation of treatment control is based on monitoring blood levels of~     growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease~     control during SA treatment is not always straightforward. It is usually based on~     normalization of IGF-I and achievement of a certain GH level. In approximately 40% of~     patients discordant values of GH and IGF-I levels are seen after treatment with SA, with~     normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation~     is unknown, but it indicates that SA may affect this difference.~      The primary objective of this study is to investigate if disease control during SA treatment~     is best achieved by monitoring either GH or IGF-I.~   "
142475|NCT01189747|"~     This study will evaluate the safety and efficacy of botulinum toxin Type A compared to~     placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).~   "
109816|NCT01618838|"~     Radiation therapy is a well-established treatment modality for clinically localized prostate~     cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live~     with the side effects for many years. Attempts have been made to protect surrounding tissues~     while delivering high dosage of radiation to cancer. With the rectum being so close to the~     prostate, many patients still suffer from side effects caused by radiation injury to the~     rectum, especially those who received conventional external beam radiotherapy.~      CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows~     radiation beams to be delivered in different directions, providing a highly conformal,~     uniform dose with steep dose gradients. Therefore, treatment with the CyberKnife~     radiosurgical system should minimize the toxicity to the surrounding structures. CyberKnife~     System also incorporates a dynamic tracking system to allow the robot to correct the~     targeting of therapeutic beams during treatment. These improvements allow for dose~     escalation within the prostate with less normal tissue toxicity.~      The purpose of this study is to estimate the proportion of patients with endoscopically~     detectable telangiectasia as the indication of radiation injury to the rectum, after~     CyberKnife Treatment for prostate cancer.~   "
109817|NCT01618825|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy adult human subjects.~   "
109818|NCT01618812|"~     In a group of children with severe and painful flatfeet lengthening procedures of calcaneus~     can be indicated. In this study the investigators use an artificial bone graft technique to~     avoid removing bone graft from the iliac crest.~   "
109819|NCT01618799|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
109820|NCT01618786|"~     This study will evaluate the efficacy of novel compliant flooring in reducing injuries due~     to falls in a long-term care facility, determine the cost effectiveness of this~     intervention, and assess perceptions about compliant flooring among staff, residents, and~     families.~      The investigators hypothesize that compliant flooring will (1) reduce the incidence of~     injuries due to falls in long-term care residents; (2) represent an overall cost-savings~     when material and implementation costs are considered relative to direct and indirect costs~     associated with injuries due to falls; and (3) be received positively by staff, residents,~     and their family members.~   "
109821|NCT01618773|"~     This observational study is designed to assess the long-term efficacy and safety of Epiduo~     (alone or in combination with other drugs) under daily clinical practice conditions in~     patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on~     quality of life and patient adherence will be assessed under marketed conditions.~   "
109822|NCT01618760|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult human subjects.~   "
109823|NCT01618747|"~     This single-arm, open-label, multicenter, observational study will evaluate the efficacy and~     safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second~     relapse. Data will be collected from eligible patients initiated on Avastin treatment~     according to local label for up to 3 years.~   "
109824|NCT01618734|"~     TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP)~     who received alternatively romiplostim and eltrombopag.~   "
109825|NCT01618721|"~     The study seeks to characterize data obtained from patients with a variety of lung diseases~     using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in~     a Doppler mode is placed on the chest wall and the unique software the investigators have~     developed analyzes the signals reflected from within the lung. On the basis of of pilot~     studies performed previously the investigators expect to receive different signals from~     different diseases that will enable diagnosis of different lung diseases.~   "
109826|NCT01618708|"~     The primary objective of this study was to demonstrate any changes in assessments of pain~     for participants receiving Synvisc-One compared to control.~   "
109827|NCT01618695|"~     The purpose of this study is to confirm the efficacy and safety of perampanel compared to~     placebo in patients with refractory partial-onset seizures~   "
109828|NCT01618682|"~     The investigators hope to gain insights into the functional organization of the human~     cerebral cortex in response to upper limb amputation and surgical interventions including~     hand replantation and hand transplantation.~   "
109829|NCT01618669|"~     The purpose of this study is to demonstrate that the strength of agreement between single~     photon emission computed tomography (SPECT) imaging with regadenoson following inadequate~     exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the~     strength of agreement between two sequential regadenoson SPECT images without exercise.~   "
109830|NCT01618656|"~     Cannabis dependence is associated with changes in the brain's cannabinoid system. When~     cannabis dependent individuals try to quit using cannabis, some of them experience problems~     that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the~     problems related to quitting cannabis may facilitate abstinence. One way to do this is by~     harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.~     One of the main endocannabinoids is anandamide. The study is based on the hypothesis that~     the problems related to quitting cannabis use will be reduced by increasing the brain levels~     of anandamide. Furthermore, by reducing the problems related to quitting cannabis, people~     will be less likely to relapse. Brain anandamide levels will be increased by blocking the~     breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects~     of a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be~     studied in a double-blind, randomized, controlled, proof-of-concept study.~     Cannabis-dependent subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1~     randomization. The trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week~     outpatient treatment phase and a 8 week follow-up phase. Abstinence and relapse will be~     measured at various times during this 12 week study.~   "
109831|NCT01618643|"~     Acetic acid chromoendoscopy is an established standard technique used to detect dysplasia~     within the gastrointestinal tract. Acetic acid spray helps to identify neoplasia by~     highlighting the surface pattern, highlighting the vascular pattern and by a process known~     as the aceto-whitening reaction, where tissues take acetic acid and turn white for a brief~     period and then slowly revert back to a normal colour. The neoplastic surface and vascular~     pattern are all very well described, and have played a big role in the recognition of early~     cancer. The aceto-whitening reaction is well described but the differential in timing~     between neoplastic and non-neoplastic areas is not well understood.~      The investigators aim to establish the differential in the timing of the disappearance of~     the aceto-whitening reaction between healthy tissue, dysplastic tissue, intramucosal cancer~     and invasive cancer after acetic acid dye spray in the oesophagus and colon. By~     understanding this better, the investigators may be able to predict with greater accuracy~     whether a highlighted abnormal area is cancer or high grade dysplasia, or whether it is low~     grade dysplasia or inflammation, which has significant prognostic implications for the~     patient.~      The investigators hypothesize that the differential in the timing of the disappearance of~     the aceto-whitening reaction between normal and abnormal tissue could help in the detection~     of gastrointestinal neoplasia.~   "
109832|NCT01618630|"~     Severe burns result in persistent and extensive fat deposition in liver and muscle tissue.~     This may be related to the prolonged insulin resistance observed following burn. In this~     study the investigators will test the hypothesis that essential amino acids act in synergy~     with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect~     insulin sensitivity. Children with burns will participate in six weeks of exercise training~     with/without amino acid supplementation. Before and after the intervention, measurements~     will be done to determine muscle and liver fat content, muscle fat and protein metabolism,~     and insulin sensitivity.~   "
109833|NCT01618617|"~     Subjects will be screened and will enter a placebo-only 2-week run-in period during which~     constipation symptoms will be evaluated and any disallowed products (e.g. probiotics) must~     be discontinued. Following successful completion of the run-in period, subjects will be~     randomized to probiotic (high or low-dose groups) or placebo. Subjects will then consume~     their assigned product daily for 6 weeks. Subjects will undergo abdominal x-rays on study~     days 0 and 42 to assess transit time with each examination preceded by 6 days of radiopaque~     Sitz marker ingestion. Subject diaries will be used to collect bowel movement frequency,~     stool consistency, concomitant medications, and adverse events each day during the trial.~     Stool samples will be collected at baseline and end of study to assess fecal probiotic~     count. PAC-QOL, WCS, and GSRS questionnaires will be administered at baseline and day 42.~     24-hour food recalls will be administered at day 0 and 42 and the following parameters will~     be assessed: total calories, carbohydrate, fat, protein, fiber, and liquid intake. Weekly~     physical activity recalls will be completed.~   "
109834|NCT01618604|"~     Conditioned Pain Modulation (CPM) is a phenomenon which isn't examined enough. Many factors~     of influence such as gender, age and psyche are already known - but the duration of such~     effects, their reliability and the correlation between standardized Quantitative Sensory~     Testing (QST) and CPM is still unknown.~      In this study the investigators expect to find parameters in QST that correlate with the~     efficacy of Conditioned Pain Modulation. Knowing factors that indicate high or low potential~     CPM could help finding patients-at-risk and adapting their therapy.~   "
109835|NCT01618591|"~     The purpose of the trial is to develop the evidence on relative efficacy of 3 available~     single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen,~     with and without loperamide, for dysentery/febrile diarrhea required for informing decisions~     among these regimens. Information from this study will be used to develop management~     guidelines for the diagnosis and management of travelers' diarrhea (TD) among deployed~     United States and United Kingdom military personnel.~   "
109836|NCT01618578|"~     The present study investigates by means of the rubber hand illusion body image stability and~     sense of body ownership in patients with CRPS of the upper limb compared to patients with~     unilateral pain of origin other than CRPS and age and sex-matched healthy subjects.~   "
109837|NCT01618565|"~     This trial tests whether hands-on training is superior to expert demonstration regarding the~     management of shoulder dystocia (stuck shoulder) during delivery on a training model.~   "
109838|NCT01618552|"~     This study will determine whether practicing primary care providers (PCPs) can be trained to~     support patient self-care of depression and co-existing diabetes during office visits, and~     begin to explore whether this might improve depression and diabetes outcomes, and whether~     the effects of the training generalize to patients with health conditions other than~     depression and diabetes. This is important because most patients with chronic conditions~     struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support~     self-care.~   "
109839|NCT01618539|"~     General Anesthesia is usually produced by an intravenous agent and then maintained with a~     breathing agent till the surgery is completed. However, there is a recent trend to produce~     and maintain general anesthesia solely with an intravenous agent, such as propofol, in view~     of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The~     depth of general anesthesia can be measured by an anesthetic depth monitoring device called~     Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well~     established whenever a breathing agent is used to maintain general anesthesia. However, the~     validity of using BIS with TIVA has not been adequately investigated. This study will~     compare the BIS values at different doses of TIVA in order to establish any correlation~     between the two. If such a correlation is established, BIS monitoring can safely be~     recommended to determine anesthetic depth under TIVA.~   "
109840|NCT01618526|"~     Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to~     have anti-inflammatory effects and to change the composition of the faecal micro flora in~     the colon.~      In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome~     are randomized to two types of diet intervention: a low and a high fiber diet. The~     participants are subjected to endoscopy before and in the end of each intervention.~   "
109933|NCT01617317|"~     Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent~     plasma from patients recovered from H1N1 2009 influenza A infection, for patients with~     severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the~     length of stay in ICU and hospital.~   "
109842|NCT01618500|"~     A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH)~     has been developed. The aim is to provide the clinician with a free of charge, standardized~     tool, assessing the cognitive decline or improvements in the cognitive domains specific for~     NPH. Results from the battery indicate good reliability and validity for the computerized~     tests~      Results from the computerised battery seems promising. However, ability for the battery to~     detect cognitive improvements after a shunt operation remains to be tested.~      Study objectives~        1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting~          on neuropsychological performance in NPH patients, using a computerized battery.~        2. Feasibility. The ability to complete the test battery by the intended patient group~          will be tested.~        3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of~          healthy individuals (from previous study).~   "
109843|NCT01618487|"~     The investigator hopes to determine if one of three current standard of care surgeries for~     lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are:~     arthroscopic tenotomy, open tenotomy, and debridement and repair.~   "
109844|NCT01618474|"~     This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel~     plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for~     stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate~     the optimal adjuvant regimen for such extremely high risk patients.~   "
109845|NCT01618461|"~     Research shows that well-developed icons and other pictorials aid in the comprehension of~     medication information and are effective in improving patients' medication management. This~     experimental study seeks to test the effect of icons and structured medication information~     on subjects' processing and recall of simulated medication instructions in a computer~     testing environment. The study planned to enroll 200 subjects.~   "
109846|NCT01618448|"~     A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy~     and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart~     Failure~   "
109847|NCT01618435|"~     The average life expectancy in Denmark is increasing resulting in an increasing part of the~     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes~     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,~     especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa~     et al.). LSS occurs in a combination of degenerative changes in the lower back, including~     hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc.~      Current treatment of LSS is varied ranging from non-operative conservative treatment to~     operation.~      Operative intervention shows very good results according to physical ability and~     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),~     but the most optimal treatment is still debated. Nevertheless, a decompression and, if~     needed, a spinal fusion is recommended.(Ausman).~      Clinical improvement including decrease of pain, improved ADL-function and an increased~     quality of life are parameters of highest interest and the purpose of an operation is clear:~     Making sufficient room for the affected nerves. In addition fusion is desired achieving~     stability avoiding a new compression of the nerves. Studies attending these issues find a~     correlation between fusion and clinical outcome, why obtained fusion of the affected levels~     are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU -~     Fischgrund et al.).~      P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no~     side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al.~     789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the~     investigators find this material suited for fusion surgery in the elderly.~      To the investigators knowledge this is the first prospective study comparing fusion rates~     and postoperative clinic with i-FACTOR vs allograft in older patients operated with~     decompression and spondylodesis because of spinal stenosis due to degenerative~     spondylolisthesis.~      Hypothesis:~      There are no difference in the clinical parameters measured by ODI and fusion rates~     comparing i-FACTOR® and allograft in non-instrumented posterolateral~     spondylodesis-operations in patients 60 years and older.~   "
109848|NCT01618422|"~     This is a prospective, randomized, parallel, controlled study comparing the efficacy and~     outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using~     pretreatment susceptibility tests in selection of chemotherapy regimens and that in another~     group without using pretreatment susceptibility test results. The investigators hypothesize~     that selecting drug treatment on the basis of known susceptibility tests would lead to~     improved outcome compared with empiric treatment.~   "
109849|NCT01618409|"~     The purpose of this randomized controlled trial is to evaluate the effect of~     Spanish-language illustrated medication instructions (PictureRx cards), compared to~     traditional medication instructions, on Latinos' understanding of their medication regimens.~     The study will also assess the effect on self-reported medication adherence. Patients with~     diabetes who attend participating clinics are eligible. The target sample size is 200.~   "
109850|NCT01618396|"~     Previous studies have demonstrated that altered microvascular blood flow is an important~     marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent~     use of sedatives and it is unknown if these agents interfere or not on microvascular blood~     flow. The goal of this study was to compare effects of propofol and midazolam infusions on~     sublingual microcirculation of septic shock patients.~   "
109851|NCT01618383|"~     The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic~     Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for~     the development of Lewy bodies disease, and a careful look at discrepancies between these~     two conditions may provide insight into the pathogenesis of PD. The early involvement of the~     enteric nervous system (ENS) during PD led to theories that an as yet unidentified external~     agent entering the ENS causes PD . If lesions of the ENS are found in patients who present~     with a genetic form of parkinsonism would go against this notion, and thus provide insight~     to the pathophysiology of the disease.~   "
109852|NCT01618370|"~     This study is a prospective, interventional, open-label, multi-center early access program~     for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate~     resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional~     short and long term safety data on the product.~   "
109875|NCT01618071|"~     Many types of cardiovascular disease begin when the layer of cells lining blood vessels~     (endothelial cells) start to function abnormally. This causes white blood cells (monocytes)~     to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are~     carried in the blood for 3-8 hours after a fatty meal in small particles known as~     chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to~     investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart~     disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize~     that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and~     activate protective mechanisms to improve the function of arteries.~   "
109853|NCT01618357|"~     The investigators' primary aim is to determine the number of participants who can handle the~     treatment within specific safety parameters, determine the number of participants who can~     handle safely the maximum tolerated dose (MTD) (within 50-200 mg/BID dose range) when~     combining Veliparib and radiation, as well as to identify side effects and their intensity~     at different dosing levels.~      The investigators' secondary aim is to determine the number of participants with~     post-operative adverse events associated with POPI as well as the pathologic complete and~     partial response rate in patients treated with POPI.~      The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers,~     and gene and protein expression profiles for correlation with tumor response to POPI. This~     will be primarily evaluated in the expansion cohort.~      Study Plan:~      It will be a standard 3+3 dose finding trial in which the MTD will be defined as the dose~     below the level at which >1 DLT is observed in 3-6 patients. Women with node positive~     disease prior to NAC and >1.0 cm residual breast disease and/or clinically positive nodal~     disease after NAC will be offered participation in the research phase of this study.~      Women with residual disease >1cm or +LN after NAC (Med Onc's choice) will be offered~     pre-operative Veliparib and concurrent whole breast and regional nodal irradiation. Four (4)~     dose levels of Veliparib will be evaluated with concurrent whole breast and regional nodal~     irradiation (WB/RNI). The starting dose of Veliparib will be 50 mg BID, will increase in 50~     mg increments to a maximum of 200 mg BID and be delivered concurrently with 235 cGy QD x 16~     to the breast and SCV/Axilla. Once the MTD is determined we will further evaluate safety~     with an expansion cohort which will bring the total number of patients treated at the MTD to~     20.~      Accrual: Up to 44 patients~   "
109854|NCT01618344|"~     To explore use of a smartphone medication reminder application to promote adherence to oral~     medications by AYA with cancer.~   "
109855|NCT01618331|"~     The hypotheses is that regular post exercise supplementation increase fitness and daily~     activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.~      All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal~     oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are~     risk of falls and daily activity level.~   "
109856|NCT01618318|"~     In the past, doctors separated people with asthma into two groups, those with allergic~     asthma (about 2/3rds of people) and those with non-allergic asthma. These labels are not~     much used now as the treatments for all people with asthma don't depend on this~     classification. However, new treatments for asthma may become available and the~     classification may again become important. It could be useful for clinicians to know how to~     identify which patients are likely to benefit from particular treatments.~      Additionally, some new blood tests are becoming available and some of these might help to~     categorise the type of asthma people have. What the study hopes to do is to identify patient~     features which make a diagnosis of allergic asthma more likely and to see which new blood~     tests are most likely to be helpful in confirming this diagnosis.~   "
109857|NCT01618305|"~     HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late~     stages of pregnancy need an effective medication regimen to reduce the risk of transmitting~     HIV to their children. This study will examine the virologic response, safety, and~     tolerability of two different ARV medication regimens in HIV-infected pregnant women who are~     between 28 and 36 weeks pregnant when they enter the study.~   "
109858|NCT01618292|"~     Compare changes in bowel function before, 6 months and one year after Robotic-assisted~     laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one~     year after Robotic-assisted laparoscopic sacral colpopexy.~   "
109859|NCT01618279|"~     The main aim of this study will evaluate differences in serum levels of tryptase in study~     population. Will be selected a number of 350 patients hospitalized for coronary heart~     disease.~   "
109860|NCT01618266|"~     Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.~   "
109861|NCT01618253|"~     To determine the maximum tolerated radiation dose with concurrent sorafenib for unresectable~     hepatocellular carcinoma that has not responded to transarterial chemoembolization.~   "
109862|NCT01618240|"~     First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators~     hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the~     ability to protect the airway during swallowing in long-term ventilated subjects. More~     specifically, the investigators hypothesized that low muscle strength is associated with the~     inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus~     residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS~     scale [1-8]> 1), which should predispose to endotracheal aspiration.~   "
109863|NCT01618227|"~     Loss of wrist flexion and extension is a common problem after wrist and forearm fractures~     that may lead to disability and unsatisfactory outcomes after fracture treatment. In many~     patients, this range of motion loss is caused by stiffness of the soft tissues. Such~     stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a~     constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of~     the soft tissues. By altering the splint's bending angle, one can incrementally increase the~     force applied on either wrist flexion or extension. There are no data comparing~     rehabilitation with static-progressive splinting to rehabilitation without~     static-progressive splinting for the restoration of wrist flexion and extension after wrist~     or forearm fractures.~      Primary study hypothesis:~      Two months after study enrollment patients that use static progressive splinting have better~     wrist flexion and extension than patients that use standard therapy techniques.~      Secondary study hypotheses:~        1. Six months after study enrollment, subjects that use static progressive splinting have~          better wrist flexion and extension than those that use standard therapy techniques.~        2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative~          pain thoughts, pain anxiety, and depression.~        3. Six months after study enrollment, subjects that use static progressive splinting have~          had fewer physical/occupational therapy visits than those that use standard therapy~          techniques.~        4. Six months after study enrollment patients that use static progressive splinting have~          had fewer additional surgeries than patients that use standard therapy techniques.~      This study will employ a prospective randomized design. Subjects will be invited to enroll~     during their routine office follow-up visit. Informed consent will be obtained. Subjects~     will be randomized on a 1:1 ratio to rehabilitation with or without static progressive~     splinting.~      All subjects will have a standard rehabilitation program including physical or occupational~     therapy and home exercises throughout the study. The static progressive splint will be~     prescribed according to the randomization sequence. Upon receipt of the splint, subjects~     will be instructed in proper application and use by their treating therapist or a~     representative of the company. Subjects will be instructed to follow the daily splint~     wearing protocol provided by the device manufacturer. Use of the splints will be~     discontinued at the patient's discretion or when a plateau phase in active range of motion~     is achieved (defined as no measurable gains in active range of motion achieved in a 30-day~     period).~   "
109864|NCT01618214|"~     This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily~     individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by~     the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2~     diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD~     background treatment: Metformin plus/minus alpha-glucosidase inhibitor.~   "
109865|NCT01618201|"~     Migraine is prevalent in 10-12% of the population. It involves the development of a cranial~     perivascular neurogenic inflammation. Recent information suggests that migraine might be a~     risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1.~     Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing~     inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory~     process.The data on the relation of migraine to inflammation is limited. The aim of the~     current study is to assess inflammatory factors as possible markers for migraine.~   "
109866|NCT01618188|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in~     subjects with type 1 diabetes.~   "
109867|NCT01618175|"~     Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in~     all population groups, and is usually due to respiratory syncytial virus (RSV) infection.~     The main cause for hospitalization is often a need for oxygen, but can also include high~     fever (with a suspected secondary bacterial infection) or increasing respiratory distress.~     In a minority of cases (some of which can be identified in advance by defining risk groups)~     a serious illness may develop, including risk of respiratory failure and death. Most cases~     will just require supplemental oxygen and suction of secretions from the nose (as listed in~     the recommendations of the American Academy of Pediatrics - AAP). However, this apparently~     simple treatment still requires continued hospitalization. This results in a sharp~     increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In~     recent years two studies from developed countries have been published where safety has been~     demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have~     not been published yet, for example for populations living in poor conditions. The General~     Health Services (Klalit) in Israel provides integrated hospital and community health service~     to the majority of the population living o in our region, thus presenting an opportunity for~     optimal interventions related to this disease.~   "
109868|NCT01618162|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in~     insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in~     combination with metformin. All subjects will continue their pre-trial SU treatment with or~     without metformin treatment without changing the frequency or dose throughout the trial.~   "
109869|NCT01618149|"~     The investigators hypothesized that the microarchitecture of bone influence the degree of~     periprosthetic bone loss after total knee arthroplasty surgery. The investigators collected~     the bone fragment at the distal femur while performing total knee replacement and take~     quantitative radiography analysis . Before and after the surgery(6 month ,12 month) , the~     investigators check the BMD at identical location of the distal femur by using dual energy~     absorptiometry. The investigators will use linear regression to evaluate the relationship~     between the microarchitecture and the degree of bone loss.~   "
109870|NCT01618136|"~     Overall Design: This is a multicenter, open-label, Phase 1/2 study which will be conducted~     in three arms (as described below). Each arm will be conducted in two parts: a Phase 1 part~     which will include dose escalation and a Phase 2 part which will include four cohorts in~     specific disease indications. Phase 1 will also include a food effect study of E7449 as a~     single agent. Once the MTD in the Phase 1 single agent arm and the Phase 1 combination arms~     of this study has been achieved, the sponsor will submit the relevant safety information and~     recommended Phase 2 dose to the IRB/Health Authorities. Arm 1: E7449 will be administered as~     a single agent. Arm 2: E7449 will be administered in combination with TMZ. Arm 3: E7449 will~     be administered in combination with carboplatin and paclitaxel~   "
109871|NCT01618123|"~     It is recognized that endothelial dysfunction is a major factor contributing to the~     atherogenic process. Abnormal function of the endothelium is detectable prior to obvious~     intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction~     is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its~     complications. Measurement of peripheral vasodilator response with fingertip peripheral~     arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging~     as a useful method for assessing vascular function. EndoPAT may be a potential valid test~     increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain~     unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a~     relatively fast non-invasive bedside test, relatively low-cost and has no side effects.~     Therefore, the primary objective of the study is to test the hypothesis that abnormal~     endothelial function as assessed by EndoPAT testing will increase the prediction of the~     short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain~     unit.~   "
109872|NCT01618110|"~     -  ADHD is one of the most common psychiatric disorders.~        -  While most of the attention is directed towards youth, 60% continue to suffer symptoms~          into adult life.~        -  Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20%~          are non-responders.~        -  Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially~          at right PFC.~        -  It is this study hypothesis that by stimulating the right PFC by TMS, it will be~          possible to alleviate ADHD symptoms.~        -  A 10 sessions of treatment will by applied on a randomly allocated group of patients,~          diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS~          treatment, and the second group will receive a sham treatment.~        -  Improvement of objective and subjective ADHD scale will be examined.~   "
109873|NCT01618097|"~     The purpose of this study is to advance the evidence base regarding methods for facilitating~     informed decisions among patients with knee and hip osteoarthritis by comparing DVD and~     online formats of decision aids for these conditions. The project will assess how these~     different formats impact key outcomes including: patient knowledge about treatment options,~     decisional conflict, preparation for decision making, decision self-efficacy, stage of~     decision making, and acceptability and usability of the decision aids.~   "
109874|NCT01618084|"~     The Trident Tritanium acetabular component of a total hip prosthesis is a new developed~     uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup~     will be compared with the Trident HA acetabular component in two equal sized groups. The~     Symax HA coated stem will be used as femoral component in both groups.~      Study Objectives:~        -  The primary objective is to determine the prosthetic migration of the uncemented~          acetabular and femoral total hip components using model based RSA technique~        -  Secondary objectives are on one hand to assess clinical outcome on the other hand~          assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score,~          WOMAC, and EQ-5D questionnaires~        -  Tertiary objective is to assess bone remodeling of the uncemented acetabular components~          and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a~          cohort of 12 consecutive patients of this RCT~      A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients~     have to fulfill the inclusion and exclusion criteria.~      All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery~     at 4 weeks, 3 and 6 months and 1 and 2 years.~   "
109878|NCT01618032|"~     Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability~     (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries.~     Passive mobilization techniques to improve ankle dorsiflexion are commonly used in~     physiotherapy treatments. However, no studies have compared manipulative techniques of~     mobilization techniques in subjects with chronic ankle instability.~      The aim of this study is to compare the effects of two mobilization techniques on ankle~     dorsiflexion in patients with chronic ankle instability.~   "
109879|NCT01618019|"~     The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid~     (PUFA) can be beneficial for the patients with rheumatoid arthritis.~   "
109880|NCT01618006|"~     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries~     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these~     operations are done each year to help relieve patients' chest pain and to prevent future~     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries~     by sewing on healthy vessels from another part of the body (usually from the leg or the~     chest). Aspirin (a blood thinner) is given to patients once a day after their surgery~     because it stops sticky cells in the blood (platelets) from blocking these new vessels~     (which may lead to a future heart attack).~      Research has shown that aspirin does not work as well in people after they have bypass~     surgery as the investigators might expect (for reasons that are not fully understood). One~     reason aspirin may not work as well after surgery is because the body makes many more~     platelets after surgery than it would under normal circumstances. All of these new platelets~     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The~     investigators believe that giving multiple daily doses of aspirin following bypass surgery~     is more effective than giving aspirin once daily at blocking platelet activity.~   "
109881|NCT01617993|"~     User questionnaire of Eeva System usability and reports of device malfunctions.~   "
109882|NCT01617980|"~     Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally~     advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different~     therapy protocols is variable, with hypoxia known to be a major factor that negatively~     influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of~     modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT),~     might allow higher dose applications to the target volume, leading to improvement of therapy~     outcome. 18F-fluoromisonidazole dynamic positron emission tomography and computed tomography~     (18F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are~     attractive strategies for imaging tumor hypoxia. The HIL trial is a single centre pilot~     study combining multimodal hypoxia imaging with 18F-FMISO dPET-CT and functional MRI and~     intensity modulated radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15~     patients are recruited in the study. All patients undergo serial 18F-FMISO dPET-CT and~     functional MRI before treatment, at week 5 of radiotherapy and 6 weeks post treatment.~     Radiation therapy is performed as inversely planned IMRT after four dimensional computed~     tomography (4D-CT) based target volume definition. Hypoxia imaging is not included in target~     volume definition or IMRT dose prescription.~      Objectives of the trial are to characterize the correlation of 18F-FMISO dPET-CT and~     functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation~     therapy on tumor re-oxygenation. Further objectives include the generation of data regarding~     the prognostic value of 18F-FMISO dPET-CT and functional MRI for locoregional control,~     progression free survival and overall survival of NSCLC treated with IMRT, which will form~     the basis for larger clinical trials focusing on possible interactions between tumor~     oxygenation and radiation outcome.~   "
109883|NCT01617967|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of ALN-TTR02 in patients with transthyretin (TTR)~     mediated amyloidosis (ATTR).~   "
109884|NCT01617954|"~     This is a prospective study that will assess the impact of MammaPrint on chemotherapy +~     endocrine versus endocrine alone treatment decisions in patients with an Oncotype~     Intermediate Score.~   "
109885|NCT01617941|"~     It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in~     patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per~     4 weeks.~   "
109886|NCT01617928|"~     This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) .~     Treatment cycles are 3 weeks in duration. The primary objective of this study is to~     determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in~     combination with carboplatin and paclitaxel in Japanese subjects with solid tumors.~     Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of~     anti-tumor activity in the subjects.~   "
109887|NCT01617915|"~     In 2011, there was an estimated 233,000 cases of invasive breast cancer, and 39,970 deaths~     from breast cancer in the United States. The vast majority of patients are diagnosed with~     Stage I-III resectable and potentially curable disease, and for these patients, the most~     pressing questions are whether adjuvant endocrine or chemotherapy are indicated, and if so,~     how to determine whether these treatments are working. Adjuvant systemic therapy reduces~     relative recurrence rates by 30-50%, depending on the age of the patient and tumor~     characteristics. However, patients with early stage disease often do not bear measurable~     markers of disease such as an elevated cancer antigen 27-29 (CA27.29) or circulating tumor~     cells. Patients with early stage breast cancer are typically treated with adjuvant therapy~     based on historical evidence showing that such therapy prolongs survival in this population.~      Lung cancer is the most common malignancy and the leading cause of cancer-related death in~     the U.S. Approximately 220,000 new cases of lung cancer are diagnosed in the U.S. every~     year. Unfortunately, lung cancers are often diagnosed at later stages than breast cancer,~     due in part to little/no effective screening for lung cancer. As with breast cancer,~     patients are commonly treated with chemotherapeutic agents, but treatment regimens can take~     several weeks to months to elicit clinically detectable anti-tumor effects. A biomarker to~     assess early tumor response to therapy would benefit this patient population.~      The contents of dying tumor cells can be detected in the bloodstream, and this may be~     enhanced by the leaky vasculature of solid tumors. Protein biomarkers of tumor cell death~     are difficult to detect due to the complex nature of plasma and the lack of technical~     sensitivity. In contrast, DNA is easier to detect through polymerase chain reaction (PCR)~     amplification. Indeed, circulating tumor DNA has been detected in plasma from patients with~     osteosarcoma, breast cancer, and colorectal cancer. Until recently, it was impractical to~     develop an assay to routinely quantify circulating tumor DNA due to heterogeneity between~     patients and tumors. Advances in genomic technology now permit sequencing a tumor genome to~     identify patient-specific genomic aberrations. Major genomic alterations (i.e., insertions,~     amplifications, deletions, inversions, translocations) can be readily detected using PCR~     primers which will recognize tumor DNA but not normal DNA.~      While this strategy may be generally applicable to diverse types of solid tumors, two issues~     are apparent in breast cancer. Firstly, the incidence of chromosomal rearrangements varies~     widely. Whole-genome sequencing of 15 breast tumors revealed a range of 1-231 major genomic~     alterations (mean= 68), where 2 tumors had 1 alteration, and 9 tumors had > 20 alterations.~     Single-base point mutations are more common but difficult to reliably detect using PCR.~     Therefore, the investigators must consider that a small subset of patients may have a~     limited number of genomic alterations available for this assay. Secondly, intratumoral~     heterogeneity may mean that some genomic alterations are not present in every tumor cell.~     Such heterogeneity has been inferred from FISH and immunohistochemistry (IHC) studies for~     many years, and is now being verified at the genomic level. The investigators must consider~     that only a subpopulation of tumor cells may be sensitive to cytotoxic therapy, so changes~     in the levels of circulating tumor DNA may only be reflected with analysis of genomic~     alterations specific to the sensitive cells.~   "
109888|NCT01617902|"~     This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following~     major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the~     hyperbilirubinemia on postoperative mortality and morbidity.~   "
109889|NCT01617889|"~     The objective is to assess the comparative fat and calcium absorption, and gastrointestinal~     (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing~     different fat blends.~   "
109890|NCT01617876|"~     When performing screening endoscopy, small focal gastric lesions are frequently encountered.~     Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging~     (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to~     enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of~     gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been~     proposed in the recognition of early gastric cancer (EGC).~      This study is based on the hypothesis as follow:~        1. The microvascular structure could be clearly observed with magnifying endoscopy~          enhanced by narrow-band imaging (ME-NBI).~        2. The microsurface architecture could be clearly observed with magnifying endoscopy~          enhanced by acetic acid-indigocarmine mixture (ME-AIM).~        3. Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE),~          has higher sensitivity and specificity for the differential diagnosing small focal~          gastric lesions.~   "
109891|NCT01617863|"~     The purpose of this study is to determine in soccer fans whether and to which extend~     positive or negative emotions during the European soccer Championship affects Central~     Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion.~   "
109934|NCT01617304|"~     The aim of the project is to investigate the effects of advanced glycation end products~     (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the~     human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is~     that i) food content of AGEs is lower using boiling and steaming cooking methods and that~     ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.~   "
143439|NCT01177280|"~     This study explored the prevalence of DDEs in a chronic pain population with cLBP and~     associated healthcare utilization and costs using a healthcare claims database.~   "
109892|NCT01617850|"~     Physical rehabilitation is a key element in the treatment of patients with cardiovascular~     diseases, and recent evidence has shown that supervised exercise programmes can prevent~     cardiovascular events, improve physical function and quality of life. Individualized~     exercise prescription based on appropriate frequency, intensity and duration is recommended.~     Furthermore, recent studies have shown that physical cardiac exercise training can influence~     inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary~     vessels. In the literature are divergent conclusions on appropriate frequency and duration~     of physical rehabilitation programs in order to improve physical function and reduce~     arteriosclerosis.~      The purpose of this study is to investigate the efficacy of an optimized physical~     rehabilitation programme compared to a conventional programme on physical fitness, health~     related quality of life and vascular inflammation.~   "
109893|NCT01617837|"~     The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea~     and vomiting in neurosurgical patients undergoing craniotomy.~   "
109894|NCT01617824|"~     Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by~     the co-existence of renal failure.~      One key aspect of chronic inflammatory diseases is the alteration in the polarization~     profile of circulating monocyte-macrophage cells.~      Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an~     anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to~     contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which,~     in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic~     patients.~      M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which~     are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4~     can affect the M1/M2 polarization balance.~      In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin,~     compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without~     chronic renal failure.~      In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects~     endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the~     pathobiology of diabetic complications.~   "
109895|NCT01617811|"~     The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on~     intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune~     functions of the patients receiving open liver resection.~   "
109896|NCT01617798|"~     Patients who are on mechanical ventilation in an intensive care unit often require diursis~     as part of their pre-extubation regimen. The drug of choice for diuresis has traditionally~     been furosemide. However, this drug cause hypernatremia (a rise in serum sodium) in a~     significant proportion of patients. Hypernatremia is traditionally treated by providing free~     water supplementation to the patient. This strategy creates a vicious and unproductive cycle~     of giving free water, and then diuresing it off. We propose a strategy for breaking this~     cycle by using a second diuretic-- metolazone-- which has a tendency to rid the body of more~     sodium, thereby minimizing hypernatremia.~   "
109897|NCT01617785|"~     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal~     revascularization strategy in multiple vessel coronary artery disease patients remains a~     subject of debate between interventional cardiologists and surgeons. Knowledge about the~     real-life revascularization pattern and outcomes in China is limited. By consecutively~     recruiting three vessel coronary heart disease patients in 23 geographically representative~     highest-rank hospitals, this study will examine revascularization strategy, and various~     real-life factors, that may affect patients lone-term recovery. Practical guidelines,~     appropriateness criteria and quality evaluative system for revascularization strategy will~     be established based on the findings, to improve patients outcomes in future finally.~   "
109898|NCT01617772|"~     The aim of the present study was to compare the effects of simvastatin and L-carnitine~     coadministration versus simvastatin, L-Carnitine monotherapy on liver enzymes ( AST,ALT )~     and liver elasticity in NASH patients.~   "
109899|NCT01617759|"~     Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in~     immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive~     procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF)~     cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for~     improving diagnostics. Therefore the performance of an established Aspergillus-specific~     nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be~     evaluated.~   "
109900|NCT01617746|"~     The purpose of this study will be to determine if blockade of endothelin 1 signalling via~     endothelin receptor A using ambrisentan or dual blockade (A&B) via bosentan can provide~     protection against methacholine induced bronchoconstriction in asthma.~   "
109901|NCT01617733|"~     Nelson's syndrome, an expanding pituitary tumour, occurs in up to 30% of adults after~     bilateral adrenalectomy for Cushing's disease, for which no medical treatment exists. Plasma~     Adrenocorticotrophic hormone (ACTH) levels in these patients remain high, they are~     characteristically deeply pigmented, and may experience neurological effects as a~     consequence of the tumour. It is not known whether the tumour growth is due to the lack of~     cortisol feedback after adrenalectomy or whether the pituitary cells were preprogrammed to~     develop into a tumour.~      There is a real need for an effective medical management for Nelson's syndrome. This is~     especially true given the increasing data on the somewhat disappointing longterm outcome of~     transsphenoidal surgery, and the increasing use of aparoscopic bilateral adrenalectomy for~     failures of pituitary surgery or even as primary therapy for Cushing's disease. Therefore,~     it is likely that there will be increasing numbers of patients attending endocrine centres~     worldwide with Nelson's syndrome following bilateral adrenalectomy as part of their~     management for Cushing's disease. In view of this it is important to investigate all~     potential avenues for the treatment of Nelson's syndrome and translate any benefits to~     patients.~      This study, designed and initiated by the investigators, will assess if pasireotide reduces~     ACTH levels and tumour volume in patients with Nelson's syndrome. Patients will be recruited~     for a period of 32 weeks and receive 4 weeks of pasireotide twice daily and then 24 weeks of~     pasireotide long acting release therapy every 4 weeks. Over the 32 week protocol patients~     will make 12 visits for serial ACTH blood measurements and have 2 MRI scans to assess tumour~     volume.~   "
109902|NCT01617720|"~     This Study is designed to observe the clinical outcomes of patients requiring mitral repair~     that were treated with the CE certified Cardinal System.~   "
109903|NCT01617707|"~     Sedative endoscopic examination using sedative premedication has been undertaken to induce~     conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely~     used as a sedative premedication because it has lots of advantages, such as a short~     half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However,~     midazolam has been used regardless of whether or not alcohol although using midazolam in~     chronic alcoholics is related to paradoxical reaction, characterized by increased~     talkativeness, emotional release, excitement, and excessive movement. In recent years,~     propofol has been used safety and effectively in sedative GI endoscopy because of its potent~     hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was~     conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam)~     with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic~     GI endoscopic procedures.~   "
109904|NCT01617694|"~     Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are~     known to reduce airway response and haemodynamic stimulation during anaesthetic recovery.~     The investigators will compare the effects of two drugs on prevention of cough during~     emergence from general sevoflurane anaesthesia.~   "
109905|NCT01617681|"~     To assess efficacy, safety and tolerability of valsartan when comparing two doses of~     valsartan in reducing and controlling blood pressure in children with hypertension with or~     without CKD.~   "
109906|NCT01617668|"~     To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in~     women with triple negative breast cancer whose tumors are positive for a defined pattern of~     gene expression~   "
109907|NCT01617655|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 24 weeks of treatment in comparison with placebo.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points~        -  To evaluate the effects of alirocumab on other lipid parameters~        -  To evaluate the safety and tolerability of alirocumab~   "
109908|NCT01617642|"~     Acute intermittent porphyria (AIP) is an autosomal dominant inherited disease, which is~     relatively prevalent in northern Norway with a total of around 90 patients. This provides us~     with a special opportunity to study AIP. AIP is caused by a mutation in the porphobilinogen~     deaminase, an enzyme in the haem synthesis. AIP presents symptoms, particularly among~     fertile women and older men. Typical symptoms are abdominal pain and dark red urine, nausea,~     vomiting, constipation, muscle weakness and nerve damage including paraesthesia and even~     paresis. This is known as symptomatic or manifest AIP (MAIP). Others do not display~     symptoms, so-called latent AIP (LAIP). AIP attacks may be triggered by a host of medicaments~     which affect the haem synthesis, infections, alcohol and stress. Treatments of~     manifestations include high sugar intake (4 sugar lumps/hour), alternatively administer~     glucose and Normosang (synthetic haem arginate) by intravenous injection and removing~     triggering factors. Diet, glucose intake, dental health and inflammatory parameters will be~     examined. This study can provide new knowledge about why only some people develop symptoms~     of AIP. Main hypothesis: There are differences in the diet, iron status, inflammation and~     glucose metabolism of the MAIP group vs. the LAIP group and the control group.~   "
109909|NCT01617629|"~     The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian~     cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer~     eligible for study participation due to disease progression.~   "
109910|NCT01617616|"~     Dysautonomia, primarily defined as postural orthostatic tachycardia syndrome (POTS) can~     seriously disrupt a child's daily activities. It is most commonly associated with nausea or~     abdominal pain. In preliminary studies, when orthostatic intolerance was treated with~     fludrocortisone, a standard therapy for orthostatic intolerance (OI), symptomatic~     improvement in nausea was observed. However, children with POTS were also observed to have~     higher supine mean arterial pressure (MAP) (preliminary data) and greater suppression of the~     baroreceptor reflex sensitivity (BRS) occurred upon up-right tilt. While fludrocortisone~     alleviates nausea associated with OI, its long-term use may pose long term health risks to~     children including worsening hypertension. Therefore, it is the objective of this study to~     define the mechanism for OI as it relates to nausea. The investigators hypothesize that OI~     resulting from changes in the autonomic nervous system is the likely mechanism for the~     nausea observed in the patients in this study. The investigators further hypothesize that~     this is potentially an early marker for future cardiovascular problems such as early onset~     hypertension and cardiac hypertrophy. The general objective of this protocol is to address~     this gap in knowledge by determining the autonomic characteristics of children with OI as~     well as defining neurohumoral profiles for these subjects to better understand the cause of~     the elevated supine in these subjects. By better understanding the potential mechanism for~     this condition, it is the investigators future goal to develop a more focused and safer~     treatment strategy. The investigators will study subjects between 10 to 18 years of age~     utilizing the tilt table to mimic daily life stressors and also measure serum levels of~     epinephrine, norepinephrine, rennin, angiotensin II, aldosterone, and vasopressin at~     baseline and during tilt. This study will generate data with high impact in that more~     rational treatments for management of dysautonomia could be chosen on the basis of the~     profile of dysautonomia and neurohumoral markers.~   "
109911|NCT01617603|"~     Type 2 diabetes is being acknowledged as a potential public health time bomb, whose~     incidence is predicted to double over the next 10 years in the UK, associated with the rise~     in obesity and increasing sedentary lifestyles. Increased insulin resistance has been shown~     to be an important feature of type 2 diabetes (especially in those presenting with obesity~     and in particular visceral or abdominal obesity). Insulin resistance is implicated as a risk~     factor of cardiovascular disease and may lead to pancreatic dysfunction through increased~     β-cell stress in the pancreas. A combination of insulin resistance and pancreatic beta cell~     failure then leads to type 2 diabetes. The main cause of morbidity and mortality in type 2~     diabetes is cardiovascular disease as the condition is associated with impaired vascular~     functioning and increased levels of oxidation markers.~      Epidemiological studies suggest dietary flavonoids decrease the risk of death from coronary~     heart disease, cancer, and stroke. Flavonoid-rich foods include fruits and vegetables as~     well as tea, red wine, and chocolate. In a cohort of elderly men, cocoa intake was inversely~     associated with blood pressure and 15-year cardiovascular and all-cause mortality. It has~     been reported that in healthy humans, consumption of flavanol-rich dark chocolate decreased~     daytime and night time blood pressure, reduced insulin resistance, and improved nitric oxide~     dependent vaso-relaxation. Another trial found that cocoa powder increased postprandial~     insulinaemia in lean young adults. These research papers have led to the hypothesis that~     chocolate containing high cocoa liquor may help to reduce the risk of developing type 2~     diabetes.~      This study is design as a double-blind, controlled, single center, randomized, parallel~     design clinical trial. The primary outcome measure is to compare parameters of insulin~     resistance and glycaemic control in volunteers with type 2 diabetes after consumption of 3~     different chocolates (one dark and two milk chocolates) with a secondary outcome of~     endothelial function, cholesterol profile and oxidative stress. Subjects will undergo~     medical screening, anthropometry, physical activity and dietary assessments before~     randomization.~   "
109912|NCT01617590|"~     This study was intended to assess the efficacy and safety of different Disease-Modifying~     Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology~     (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid~     arthritis.~   "
109913|NCT01617577|"~     Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white~     blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for~     bone marrow transplantation. In studies of thousands of healthy donor subjects treated with~     G-CSF, the side-effects profile has been reported to be mild and reversible. Currently,~     G-CSF is under investigation in clinical trials in Germany and the US that aim to enhance~     recovery from strokes and heart attacks. In animal studies, G-CSF has been observed to~     improve cognitive performance and to markedly reduce amyloid deposition in hippocampus and~     entorhinal cortex in a mouse model of Alzheimer's Disease (AD). Since this drug is being~     used safely in many people throughout the world, the investigators hypothesize that it will~     also be safe to give to patients with Alzheimer's disease and that it may improve some~     aspects of memory and thinking. The present pilot study has two goals or objectives: 1) to~     investigate the effects of a five day schedule of Filgrastim administration on cognitive~     function and 2) to assess its tolerability and safety in a small group (12 patients) with~     mild to moderate stage AD. Patients who are eligible for the study will be randomly assigned~     to one of two groups (n=6 per group). One group will receive a five-day course of Filgrastim~     injections and the other group of subjects will receive vehicle injections (solution without~     drug). At the end of the first phase of the study (week 8), the groups will cross over to~     receive either vehicle or Filgrastim as appropriate. In this way all subjects will have~     received the active medication by the end of the study. After the study is finished the~     investigators should know whether or not Filgrastim improves some aspects of thinking and~     memory. And the investigators should know whether or not it is safe to give this medication~     to patients with Alzheimer's disease. To ensure that the drug is safe, a Safety Monitoring~     Committee will oversee the entire study. They will review all laboratory data, including~     complete blood counts, serum chemistry, EKGs and adverse events.~   "
109914|NCT01617564|"~     Paracervical blockage can reduce severe pain during second trimester induced medical~     abortion.~   "
109915|NCT01617551|"~     Catheter based renal denervation (CRD) in humans represents a promising new treatment of~     resistant hypertension. CRD is currently investigated as a treatment option in patients with~     resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic)~     in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients~     are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by~     which CRD reduce blood pressure are only partly understood and the interaction between renal~     sympathetic nerves and nitric oxide (NO) has not been investigated in humans.~      To Study the interaction between NO and renal sympathetic nerves, we designed the present~     substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables~     are studied before and after CRD.~   "
109916|NCT01617538|"~     Objective:~      To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after~     24-week atorvastatin treatment using CEUS, CTA and DSA.~      Study design:~      Total 30 patients (60 arteries) will be enrolled in this study, who had MCA infarction~     within 6 months prior to screening, and has not received any statins treatment before~     stroke.~      Eligible patient will receive atorvastatin 40mg treatment for 24 weeks. Hemodynamics changes~     and MCA stenosis will be evaluated using CEUS at baseline, 3-month,and 6-month. MCA~     stenosis, bloodstream velocity, as well as clinical symptoms will be assessed at each visit~     and compared to baseline.~   "
109917|NCT01617525|"~     The primary aim of this study is to compare, in a group of at-risk individuals, the role of~     three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended~     Korean pattern; b) the typical American diet, based on national dietary intake surveys; and~     c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on~     intestinal microbiota and on inflammatory biomarkers.~   "
109918|NCT01617512|"~     The purpose of this study is to determine if it is possible to identify activities in the~     daily accelerometer measures of a person with urinary disorders.~   "
109919|NCT01617499|"~     The aim of this pilot study is to evaluate the effects of a worksite wellness program on~     physical activity and cardiovascular disease risk factors among university employees. The~     investigators hypothesize that the proposed worksite wellness program will be effective for~     increasing daily physical activity and improving one or more cardiovascular disease risk~     factors among university employees.~   "
109920|NCT01617486|"~     This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for~     Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT)~     and designed to reduce overweight in postpartum teens. The intervention will focus on the~     replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and~     sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion~     size, and walking).~   "
109921|NCT01617473|"~     The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic~     transplantation setting as an alternative to bone marrow (BM).It was found that the use of~     PBSCs is associated with faster hematologic recovery but have yielded differing results~     regarding the incidence of graft-versus-host-disease (GVHD) and relapse.~      The study hypothesis:~      transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had~     comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs~   "
109922|NCT01617460|"~     The objective of this study is to investigate the safety and efficacy of aripiprazole orally~     administered over long term in subjects who complete a short-term treatment study of~     pediatric Autistic Disorder (031-11-002 study).~   "
109923|NCT01617447|"~     The objective of this study is to investigate the efficacy and safety of aripiprazole orally~     administered over a period of 8 weeks in pediatric patients with Autistic Disorder~   "
109924|NCT01617434|"~     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is~     to investigate the effect of liraglutide versus placebo when added to basal insulin~     analogues with or without metformin in subjects with type 2 diabetes.~   "
109932|NCT01617330|"~     Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been~     associated with inducing and enhancing allergies in children and adults. To investigate the~     basis for this association, a controlled exposure of allergic rhinitics to diesel exhaust~     was performed at a dose known to be pro-inflammatory in healthy individuals.~      The hypothesis was that airway inflammation would be augmented in allergic rhinitics~     following exposure to diesel exhaust at an environmentally pertinent particulate matter~     concentration.~      Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both~     diesel exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate~     combustion particles, mean diameter 80 nm) and filtered air for two hours on separate~     occasions. Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed~     18 hours post-exposure, and samples were analysed for markers of inflammation.~   "
112313|NCT01586195|"~     This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf~     (vemurafenib) in patients with locally-advanced, unresectable, stage IIIc or metastatic~     melanoma and activating exon 15 BRAF mutations other than V600E.~   "
109925|NCT01617421|"~     Background:~        -  People with arthritis should be active. Regular exercise leads to less pain, more~          energy, improved sleep, and better day-to-day function. Yet arthritis is one of the~          most common reasons people give for limiting activities.~        -  Yoga for arthritis has been studied before. However, few studies have included~          minorities. Making changes to yoga classes based on language and culture may help~          people use yoga to care for their arthritis symptoms. Researchers want to see if~          minority populations with arthritis will come to and benefit from yoga classes.~      Objectives:~      - To see if yoga classes designed for people with arthritis will be acceptable to minorities~     with arthritis.~      Eligibility:~        -  Adults at least 18 years of age who are enrolled in the Natural History of Rheumatic~          Disease in Minority Communities study.~        -  Participants will have osteoarthritis or rheumatoid arthritis.~        -  Participants will be able to speak and read English or Spanish.~      Design:~        -  The total study period covers 10 weeks.~        -  The first study visit will include an initial questionnaire about health and arthritis.~          Participants will also have a physical exam.~        -  Participants will have yoga classes twice a week for 8 weeks. The classes will be 1~          hour long each.~        -  After completing the yoga classes, participants will complete another questionnaire~          about their health. They will have a final physical exam.~        -  Follow-up contact will be made 3 months after the end of the study.~   "
109926|NCT01617408|"~     Background:~      - The brain has two systems for recognizing objects. One system recognizes what an object~     is, and the other system recognizes where the object is located. However, there is much~     about how the brain handles and interprets the information from these two systems that is~     still unclear. Researchers want to study the parts of the brain that are involved in how~     vision is processed. They will use magnetic resonance imaging (MRI) and transcranial~     magnetic stimulation (TMS) on the brain. MRI measures what parts of the brain become more~     active when tasks are performed. TMS uses magnetic pulses to temporarily change the activity~     in parts of the brain.~      Objectives:~      - To better understand how people visually recognize different types of objects.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  This study includes many different experiments on vision. Each experiment may combine~          visual tasks, MRI scans, and TMS. Participants may be asked to have several different~          tests. Each test will require a separate visit to the National Institutes of Health.~        -  Participants will be screened with a physical exam and medical history. They will have~          a baseline brain scan at the first visit.~        -  Participants may do visual tasks alone, with MRI only, with TMS only, or with MRI and~          TMS combined. For the visual tasks, they will look at pictures of objects on a computer~          screen. Sometimes the images will appear very briefly (less than one-tenth of a~          second). Sometimes they will appear for up to 5 seconds. These images will be of things~          like faces, bodies, tools, and scenes. Participants will be asked to respond in~          different ways to the pictures. They may respond by typing on a computer keyboard or by~          pressing a button. Participants will have time to practice the tasks before the~          experiment.~        -  Participants will remain on the study for up to 3 years.~   "
109927|NCT01617395|"~     Background:~      - Research shows that both genes and the environment influence a person s risk for getting~     multiple sclerosis (MS). However, it is not possible to accurately predict who will develop~     MS. Researchers want to study people with MS and their family members. They have developed a~     Genetic and Environmental Risk Score for MS. This score combines information from a person's~     medical history and genes. It also includes environmental factors that may be related to~     developing MS. This study will test this risk score to see if it can help predict who will~     develop MS.~      Objectives:~      - To evaluate a score for genetic and environmental risk factors that may help predict~     whether a person will develop MS.~      Eligibility:~        -  Individuals at least 18 years of age who have MS.~        -  Individuals between 18 to 50 years of age who are the parent, brother, sister, or child~          of a person with MS.~      Design:~        -  People with MS will allow researchers to look at their personal and medical data. These~          data will have been collected in other MS-related studies.~        -  Relatives of people with MS will fill out a questionnaire and give blood and saliva~          samples. They will fill out the questionnaire again one year later.~        -  Some relatives will have additional optional testing. These tests will include a~          physical exam and imaging studies. There may also be other tests. These tests may be~          repeated every 1 to 5 years for 20 years.~   "
109928|NCT01617382|"~     The purpose of this study is to register the follow-up data of patients who, because of a~     peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.~   "
109929|NCT01617369|"~     The purpose of this research study is to learn about how long hypertonic saline (HS) works~     in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat~     Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus~     builds up in the lungs. Hypertonic saline and other medications currently being developed~     may help patients with these lung diseases by speeding up mucus clearance from the lung. For~     these treatments to be effective, they likely need to be able to act for at lease several~     hours. Investigators are able to measure how lung treatments like hypertonic saline work by~     conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how~     long hypertonic saline works in people who do not have CF. Investigators plan to use this~     information to improve the design and testing of new treatments for patients with chronic~     bronchitis.~      Objectives:~        1. The investigators will use MCC measurements to determine the durability of action of~          hypertonic saline in healthy (i.e. non-CF) subjects.~        2. The investigators will determine the intra- and inter-individual variability of~          baseline MCC measurements using a slow inhalation/large particle protocol in healthy~          subjects to guide future sample size calculations.~   "
109930|NCT01617356|"~     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be~     quite long lasting and debilitating. Dextrose injection with a small needle has be notably~     helpful in preliminary studies in reducing pain and improving jaw function. This randomized~     trial will compare dextrose injection with saline injection for temporomandibular(jaw)~     dysfunction, also known as TMD.~   "
109931|NCT01617343|"~     Spatial neglect represents one of the major cognitive disorders following stroke. Patients~     patients fail to be aware of objects or people to their left and orientate instead to their~     right side. Enduring neglect has been found to be a poor prognostic indicator for functional~     independence following stroke. Despite some promising experimental accounts there are no~     established treatments for this condition.~      The aim of this study is to test whether a combined treatment with hemifield eye patching~     (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve~     functional outcome in patients with hemispatial neglect following stroke.~      The investigators hypothesise that the treatment with HEP and OKS will lead to a greater~     reduction of neglect scoring in the neglect test battery as well as a greater improvement in~     functional independence scores as compared to the spontaneous clinical course of the~     usual-care control group.~   "
109936|NCT01617278|"~     The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to~     an increased yield of adenomas in the colon among a population at increased risk for CRC.~      Primary Outcome:~      To estimate the mean number of adenomas per colonoscopy for both high definition white light~     colonoscopy and I-scan enhanced colonoscopy~      Secondary Outcomes:~        1. To estimate the recruitment rate~        2. Number of adenomas detected in the right colon during the second look~   "
109937|NCT01617265|"~     The purpose of the present study is to determine whether administration of sedation~     according to a strategy including a bundle of measures to prevent oversedation is associated~     with a reduction in mortality of intensive care unit patients requiring mechanical~     ventilation, compared to administration of sedation according to usual practices.~   "
109938|NCT01617252|"~     The main objective of this study is to evaluate the gas exchange (ventilation-perfusion~     ratio) with the system Optiflow® compared to facial mask among patients having an acute~     respiratory failure after cardiac surgery.~   "
109939|NCT01617239|"~     The goal of the study is to assess the safety and immune response after vaccination with~     different doses and vaccination schedules of virosomal influenza vaccine.~   "
109940|NCT01617226|"~     This is a multicentre, open-label, randomised phase II trial comparing azacitidine~     monotherapy with combined azacitidine and vorinostat in patients with newly diagnosed,~     relapsed or refractory acute myeloid leukaemia or high risk myelodysplastic syndromes~     ineligible for intensive chemotherapy.~   "
109941|NCT01617213|"~     This trial will determine the feasibility and efficacy of lenalidomide as maintenance~     therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200~     mg/m2) with autologous PBSC transplant.~   "
109942|NCT01617200|"~     Participants who have completed the 6-week trial P05688 can be screened for eligibility for~     this 26-week extension study in which they will continue treatment. The purpose of this~     trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered~     sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg~     orally once daily (QD) is used as an active control.~   "
109943|NCT01617187|"~     The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually~     twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms)~     as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15~     mg orally once daily (QD) was used as an active control. The primary hypothesis is that at~     least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms~     as measured by the change from Baseline in the PANSS total score at Day 42. The first key~     secondary hypothesis is that at least one of the asenapine doses is superior to placebo in~     improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global~     Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is~     that at least one of the asenapine doses is superior to placebo in improving schizophrenia~     symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS~     Total Score) at Day 42.~   "
109944|NCT01617174|"~     The first goal of this study is to learn more about the experience of pain and other~     symptoms in men being treated for advanced prostate cancer. The second goal of the study is~     to identify reliable ways of measuring pain which will be used in future clinical trials of~     treatments for advanced prostate cancer.~   "
109945|NCT01617161|"~     We are studying whether men being treated for prostate cancer have the same amount of side~     effects from either one of two different external radiation treatments: IMRT or PBT. With~     IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is~     another type of external radiation treatment for prostate cancer that is used in a few~     centers in the United States. Protons are tiny particles with positive charge that can be~     controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses~     proton beams instead of x-ray beams.~      IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing~     surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer~     and are thought to be equally effective at curing prostate cancer. However, both treatments~     have also been shown to cause the potential side effects of radiation, including bowel,~     urinary and erectile problems. It is possible that side effect rates with PBT will be lower,~     the same, or even higher than with IMRT, but this has not been studied well to date. Though~     both of these radiation therapies have been used in the past to treat prostate cancer, there~     has never been a study that compares the effects of these two therapies to see which one has~     less side effects.~      In this research study, we are comparing IMRT to PBT to determine which therapy best~     minimizes the side effects of treatment.~   "
109946|NCT01617148|"~     This study will examine the use of Aflibercept in patients with exudative macular~     degeneration requiring intravitreal injections. Patients will be followed for 12 months.~   "
109947|NCT01617135|"~     The purpose of this study is to determine the safety, efficacy and pharmacokinetics~     following administration of CVT-301 in treatment of off episodes in Parkinson's Disease~     patients.~   "
109948|NCT01617122|"~     This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe~     and effective as an antigen used in the evaluation of primary and secondary immune~     responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small~     blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14~     days, and 28 days. Blood is collected at intervals following the administration of the~     bacteriophage and the number of phage/ml is determined by the agar overlay method using~     suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are~     measured by neutralization assay. Capacity of switch from IgM to IgG is determined.~   "
109949|NCT01617109|"~     The primary objective of this randomized, double-blind, placebo-controlled trial is to~     determine the effect of vitamin D and calcium supplementation (800IU and 2000mg,~     respectively) on biochemical indicators of nutritional status and bone health in military~     personnel during Army basic combat training (BCT) and Air Force basic military training~     (BMT).~      The investigators hypothesize that daily supplementation with vitamin D and calcium during~     military training will improve vitamin D status, stabilize PTH levels, and result in~     improvements in markers of bone health. As a result of the investigators study design, the~     findings will provide critically important data regarding the concentration of vitamin D in~     blood necessary to stabilize PTH levels and to optimize bone formation during initial~     military training.~   "
109951|NCT01617083|"~     The purpose of this research study is to know if the antibiotic azithromycin, an antibiotic~     approved by the U.S. Food and Drug Administration (FDA) for treating infections, improves~     symptom severity in children with sudden and severe onset obsessive compulsive symptoms~     known as PANS, Pediatric Acute Onset Neuropsychiatric Syndrome, and PANDAS, Pediatric~     Autoimmune Neuropsychiatric Disorder Associated with Streptococcus. This study seeks to~     compare the effects of placebo vs. azithromycin on Obsessive Compulsive Disorder (OCD)~     symptom severity as well as to assess immune risk factors in children with PANDAS/PANS.~     Obsessions are repetitive, unwanted thoughts or worries that may be unpleasant, silly, or~     embarrassing. Compulsions are repetitive or ritualistic actions that are performed to ease~     anxiety or worries. Doctors think these symptoms may be caused or exacerbated by certain~     infections such as Streptococcus pyogenes, Mycoplasma pneumonia, Borrelia burgordfi, etc.~     These infections commonly cause strep throat, walking pneumonia, and Lyme Disease, among~     others.~      This study will involve a 4 week double-blind, placebo-controlled randomized trial of~     azithromycin (Double Blind Phase). At the end of this 4 week trial, the child will be~     assigned to azithromycin for 8 weeks (Open Label Phase). At the end of these 12 weeks, a~     Naturalistic Observation phase will assess the child's symptom characteristics for up to 40~     weeks.~      The study hypothesizes that children receiving antibiotic will show significantly greater~     overall improvement in severity compared with placebo, and that children with sudden onset~     of OCD and whose subsequent course shows dramatic fluctuations will have evidence of immune~     risk factors that predisposes to this presentation.~   "
109952|NCT01617070|"~     This study examines the effect of tetrahydrobiopterin (Kuvan) and Large Neutral Amino Acid~     (LNAA) therapy on melatonin and dopamine levels in individuals with Phenylketonuria (PKU).~     The investigators hypothesize that Kuvan therapy will improve melatonin secretion and urine~     dopamine levels to some extent. However significantly greater responses in melatonin and~     dopamine secretions may be observed with combined treatment with Kuvan and supplementation~     of LNAA.~   "
109953|NCT01617057|"~     The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid,~     Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis~   "
109954|NCT01617044|"~     A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic~     (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron~     deficiency in children with Restless leg syndrome (RLS) and iron deficiency. One hundred~     children with diagnosis of RLS will be recruited over a two- year period.~   "
109955|NCT01617031|"~     The aim of the study is to evaluate platelet function variations according to the delay~     since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous~     Coronary Artery Disease.~   "
109956|NCT01617018|"~     PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients~     receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous~     psoriasis. It is resulting from the merging of two studies that share the same study~     population but address different objectives: PSOBIO, developed by academic dermatologists~     and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE~     DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing~     on safety issues, and Pso-TEQ, developed by industrials at the request of the French~     Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.~      The overall general objective of PSOBIO is to assess in real life the safety and efficacy~     of biotherapies in the treatment of cutaneous psoriasis in comparison with major~     conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the~     modalities of use of biological therapies in real life and long-term benefit.~   "
109957|NCT01617005|"~     This observational study will evaluate the safety and efficacy of tocilizumab in~     participants with active moderate to severe RA and an inadequate response to non-biologic~     DMARDs. Data will be collected from each eligible participant initiating tocilizumab~     treatment over 6 months.~   "
109958|NCT01616992|"~     Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and~     extensive disability in a large group of women int he prime of their productive lives.~     Extensive study of the bladder itself has uncovered many abnormalities, but the~     investigators do not know if these are the cause or result of the disorder. None of these~     has led to any real long-term progress in treatment, so far. The investigators have found~     that other autonomic disorders often occur in both the patients themselves and in the family~     members of patients with IC/PBS. The investigators therefore propose to determine whether~     the main abnormality in IC/PBS actually lies in the autonomic nervous system, rather than~     the bladder. The investigators will do this through careful measurements of autonomic~     function and sensation in patients who have IC/PBS, both at rest, and under controlled~     psychological stress. The investigators will compare their measurements to patients with~     myofascial pelvic pain, to know which abnormalities are truly linked to IC/PBS, and which~     simply reflect the presence of pelvic pain.~   "
109959|NCT01616979|"~     During cardiac displacement for off-pump coronary artery bypass(OPCAB) surgery, the presence~     of air underneath the displaced heart compromises the transgastric (TG) window for~     transoesophageal echocardiography(TOE). The investigators hypothesised that placing a~     saline-filled glove would enhance TG transmission of ultrasound and facilitate TOE imaging~     for monitoring left-ventricular regional wall motion (LV-RWM). For left circumflex coronary~     artery (LCX) grafting in OPCAB surgery (n=13), mid-oesophageal (ME) and TG TOE images are~     recorded before cardiac displacement (T control), after displacing and stabilising the heart~     (T-displaced), and after placing a saline bag (saline-filled surgical glove) underneath the~     displaced heart (T-saline bag). Following data are determined by integrated TG and ME TOE~     views (ME+TG) at T-control, T-displaced and T-saline bag: number of readable segments (NRS)~     in a 17-segment model; NRSs in basal and mid-TG short axis views; NRS in 5-LV segments of~     the LCX territory; the incidence of inadequate monitoring of LV-RWM (NRS < 14/16 except for~     the apex in 17-segment model).~   "
109960|NCT01616966|"~     Vocal cord injuries occur not only during tracheal intubation, but also during surgery and~     during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle~     relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less~     vocal cord injuries than a total intravenous anesthesia with propofol.~   "
144229|NCT01166776|"~     The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as~     a scaffold for tissue regenerative applications, including avascular necrosis.~   "
109961|NCT01616953|"~     The purpose of this research is to determine if a patient's own bone marrow tissue can help~     regenerate bone in the area of the jaw where an implant will be placed. The name of the~     process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be~     collected and sent to a laboratory where it will be processed to form more cells. These new~     cells will then be transplanted in the regenerative site. The researchers are testing to see~     if these cells (BRC) will help form bone. The research will also determine if the implant~     will be more stable in the area with new bone growth.~   "
109962|NCT01616940|"~     The purpose of this study is to determine whether an enhanced peer intervention is effective~     in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.~   "
109963|NCT01616927|"~     Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst~     formation in both kidneys, in most patients leading to end stage renal disease. It is the~     most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons.~     The majority of patients also have progressive cyst formation in the liver, leading to pain,~     gastrointestinal discomfort and sometimes the need for liver transplantation. At present~     there is no proven therapeutic intervention to slow the rate of disease progression in human~     ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of~     major importance.~      In this respect, somatostatin analogues are promising for especially polycystic liver~     disease, but also for the renal phenotype. However, the studies that have been performed~     thus far with these agents, were underpowered and of too short duration to reach a~     definitive conclusion on the potential reno- and hepatoprotective efficacy of somatostatin~     analogues. Therefore, the present study is designed as a randomised clinical trial with~     sufficient duration of follow-up to investigate whether the somatostatin analogue Lanreotide~     slows progression of polycystic kidney and liver disease in ADPKD-patients.~      To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1.73 m2) will be~     randomized 1:1 to standard care or monthly subcutaneous lanreotide injections on top off~     standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up~     visit. During these visits, questionnaires will be filled in, physical examinations will be~     performed, blood will be drawn and urine collected. After study completion, rate of renal~     function decline in lanreotide treated subjects will be compared to that of subject who~     received standard care.~   "
109964|NCT01616914|"~     Delirium has been associated with clinical outcomes in critical care setting. However, its~     subclinical form has not been investigated. The investigators aimed to establish the~     association of subclinical delirium with outcome.~   "
109965|NCT01616901|"~     The decision to extubate a patient after acute respiratory failure is based on clinical~     observation and measurement of pulmonary mechanics. Current extubation criteria(tidal~     volume, respiratory frequency...) lack of specificity. The best way to evaluate and predict~     patients breathing abilities after extubation is to challenge him to a spontaneous breathing~     trial (SBT) with endotracheal tube in place immediately before extubation to predict the~     patient's ability to breathe spontaneously after extubation. The intention is to~     approximate, while the patient is still intubated, the work of breathing that will be~     required of the patient after extubation. Different approaches of ventilatory settings are~     currently used for the preextubation SBT, whether pressure support ventilation (PSV),~     continuous positive airway pressure (CPAP), or spontaneous ventilation through an~     endotracheal tube (T piece), all supported by literature with different benefits. To the~     investigators knowledge, few studies define which mode of ventilation most closely~     approximates the work of breathing during spontaneous respiration after extubation, and none~     have studied a specific population of obese patient in respiratory weaning. The main~     objective of the investigators study is to determine, between five different SBT, which one~     is the best to approximate the work of breathing of obese patient after extubation.~   "
109966|NCT01616888|"~     The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting~     balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.~   "
109967|NCT01616875|"~     26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4~     cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given~     intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the~     overall response rate and to determine whether this approach warrants further research of a~     phase II/III study.Participation in 2 sub studies will also be offered to the participants.~        1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after~          cycle 1 and cycle 3.~        2. A pilot sub study involving the circulating tumour cell concentration from blood~          samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery~   "
109968|NCT01616862|"~     Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung~     infections in people with CF. Many young children do not have Pa in their lungs but will~     become infected as they get older. The investigators want to learn more about how Pa is~     passed from person to person, especially to someone with Cystic Fibrosis (CF).~   "
109969|NCT01616849|"~     This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of~     this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with~     nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.~   "
109970|NCT01616836|"~     The aim of this study is to determine the best method of pain control that will help with~     rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain~     control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is~     placed beside the nerve that provides sensation to a large part of the knee and local~     anesthetic infused after surgery causing numbness to the surgical site. A single injection~     method also exists and may provide similar benefits. Both methods require training and can~     result in side effects such as temporary weakness (while the local anesthetic is still~     working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the~     joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause~     weakness and can be done quickly at the end of surgery. It is unknown if the pain control~     provided by LIA is as good as that of FNB. This study will compare the femoral nerve block,~     continuous femoral nerve block and LIA technique to determine which provides better pain~     relief after TKA.~   "
109974|NCT01616784|"~     For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal~     while avoiding hypoglycaemia but this is severely limited by the relative crudeness of~     current insulin delivery in comparison with the physiology of the β-cells which secrete~     insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted~     according to eating and exercise. Insulin can now also be administered using a pump (CSII),~     which is a device, roughly the size of a mobile phone and containing sufficient insulin to~     supply both the needs of basal metabolism throughout the day, and the boluses which have to~     cover meals. The use of CSII is expensive compared to injections, but there are important~     potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia~     (low blood sugar) and a more flexible lifestyle and better quality of life. There have been~     no trials in adults that have compared CSII treatment with MDI where the same structured~     training in intensive insulin therapy has been given, so the precise benefit of the pump~     technology is still unclear. There is a need to establish this, and identify patients who~     benefit the most so that the Department of Health can calculate the proportion of adults~     that would benefit from CSII therapy and so ensure that commissioning bodies provide the~     necessary reimbursement. The aim of the trial is therefore to establish the added benefit of~     CSII therapy over multiple injections on glycaemic control and hypoglycaemia in individuals~     with Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For~     Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on~     quality of life and cost effectiveness.~   "
109975|NCT01616771|"~     The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct~     laryngoscopy in patients whose airway management are anticipated difficult (C&L grade ≥3) by~     comparing the laryngoscopic view. Also, the investigators compared the effectiveness of~     smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight~     (GVLw) in the same patients.~   "
109976|NCT01616758|"~     The primary efficacy analysis will be the clinical benefit at 6 months as measured by a~     modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary~     endpoints of objective response rate, progression free survival, time to progression,~     duration of response, effects on physical function, and effects on tumor progression in~     women with Androgen Receptor positive breast cancer will also be assessed.~   "
109977|NCT01616745|"~     The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics~     of Korean Nontuberculosis Mycobacteria (NTM) patients.~   "
109978|NCT01616732|"~     The investigators hypothesise that testosterone therapy will synergize with dietary~     intervention to achieve weight loss. Obese men will receive diet, and be randomised to~     either testosterone therapy or placebo. Primary outcomes will be weight and body~     composition.~   "
109979|NCT01616719|"~     DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for~     Cervical Degenerative Disc Disease. This study is being conducted to determine the~     effectiveness of the graft, and to find out whether or not it provides better results or~     faster healing than traditional ways of performing surgery for Cervical Degenerative Disc~     Disease.~   "
109980|NCT01616693|"~     The percentage of participants with a serologic immune response (seroconversion or four-fold~     rise in rotavirus IgA antibodies) to rotavirus vaccine at 14 weeks of age among infants~     receiving zinc or probiotic supplements will be at least 15% higher and significantly better~     to that of infants who receive a placebo for zinc or probiotic supplement.~   "
109981|NCT01616680|"~     The purpose of this research is to test the safety and efficacy of brentuximab vedotin in~     patients with acute skin graft-versus-host disease (GVHD)~   "
109982|NCT01616667|"~     The aim of this study is to investigate the clinical outcome of the two different, but~     widely used, surgical approaches (Posterior approach and Lateral approach) of primary total~     hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one~     main study and two sub-studies. The main study investigates the patient-reported outcome~     measures (questionnaire) within the first year post surgery. The two sub-studies~     investigate; i) the level of physical function and pain within the first 3 month after~     surgery, and ii) investigate the potential difference the two approaches have on~     gait-patterns and maximal isometric hip-muscle-strength, within the first year after~     surgery. Both approaches are described with potential drawbacks. Posterior approach has a~     higher risk of dislocation of the prostheses and revision due to dislocation compared with~     Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of~     pain, lower physical function, gait abnormalities and muscle weakness, leading to less~     satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more~     investigation is needed to determine the extent of differences.~   "
109983|NCT01616654|"~     To assess the efficacy and safety of different concentrations of CD5789 cream in subjects~     with acne vulgaris for the purpose of dose identification.~   "
109984|NCT01616641|"~     Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in~     the physical examination of patients with RA, the joints in the area of the jaw and neck may~     also be affected in this disease and have their involvement usually underdiagnosed. There~     are few studies evaluating the incidence of orofacial alteration in the examination as well~     as the correlation between bite force (BF) and clinical and functional parameters in these~     patients. The aim of our study was to chacacterize the orofacial alterations in RA patients,~     correlate the results of the orofacial evaluation with clinical and disease activity~     parameters, and correlate the bite force with the hand strenght.~   "
110007|NCT01616342|"~     The purpose of this study is to determine the degree to which spinal cord stimulation added~     to comprehensive medical management can provide increased relief of chronic pain in patients~     with injuries sustained while on active military duty, measured by patient assessments of~     pain.~   "
110055|NCT01615718|"~     In this study, the investigators aim to investigate the effects of non-invasive~     neurostimulation - low-intensity transcranial electrical stimulation in conjunction with~     transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease.~     The investigators want to see if there is a difference between active and sham stimulation~     on these motor symptoms.~   "
110056|NCT01615705|"~     The purpose of this study is to evaluate whether biomarkers of inflammation, genetic~     thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in~     patients with symptomatic proximal deep venous thrombosis.~   "
109985|NCT01616628|"~     Identifying effective strategies for improving healthier eating for low- income populations~     is both a clinical challenge and a public health priority. Approximately one-fifth of the~     children in the United States are either overweight or obese. Obesity is even more common in~     low- income populations as are other related health conditions such as diabetes,~     hypertension and cardiovascular diseases.~      The consumption of fruits and vegetables is strongly associated with the prevention and~     management of obesity and diabetes and cardiovascular diseases. Overall, only about 38% of~     Americans consume the recommended servings of vegetables and only 23% consume the suggested~     amount of fruit. Close to 20% of low- income households do not purchase fruits and~     vegetables at all.~      The proposed research offers an opportunity to investigate a different approach to~     incentives for healthier eating in a low-income urban population. Specifically, this study~     will examine a rewards-based incentive for fruit and vegetable purchases with rewards based~     on cumulative purchases. Previous studies have shown that incentives may be an effective~     means of promoting behavior change. The proposed study will provide essential data about the~     impact of targeted incentives to promote acquisition of fruits and vegetables by individuals~     living in households with young children. The investigators plan to design a subsequent,~     larger study based on the results of this study. In the proposed study, the investigators~     will specifically contribute to this knowledge by investigating the effects of rewards-based~     incentives that provide delayed reinforcement.~      SPECIFIC AIMS AND STUDY HYPOTHESES~      The goal of this study is to investigate whether incentives to low-income families to~     encourage purchase of healthier foods can be used to help stem the tide of childhood~     obesity. Although this study is a randomized trial, a major function is collecting data to~     be used in the design of a larger randomized controlled trial comparing two different~     interventions using incentives to promote healthier eating in low-income communities. The~     investigators will test a supermarket gift card with rewards based on purchases of fruits~     and vegetables during the intervention periods. The specific objective is to determine~     whether that incentive system—(where the rewards can be used to purchase anything in that~     supermarket) increases healthier food purchasing practices by low-income families. The~     primary outcomes are: number of servings, and percent of total food dollars spent on fruits~     and vegetables (fresh and frozen). The primary hypotheses are:~        1. Households in the intervention group will purchase more fruits and vegetables than~          controls per week, both during: a) each intervention phase as compared to the baseline~          period and b) in the follow up phase compared to the baseline period. (Between group~          comparisons over time of intervention versus control group)~           The secondary hypotheses are:~        2. Households in the intervention group will purchase more fruits and vegetables per week~          both during: a) each intervention phase as compared to the baseline period and b) in~          the follow up phase compared to baseline. (Within group comparisons over time)~   "
109986|NCT01616615|"~     To establish wether a prophylactic intervention from first trimester with low-dose of~     aspirin improves trophoblastic invasion evaluated at third trimester in women defined as~     high-risk by abnormal uterine artery Doppler at first trimester~   "
109987|NCT01616602|"~     For obese patients, a randomized trial aimed at determining whether colonoscopy performance~     and patient comfort is improved if a patient is in the prone position (lay on their abdomen)~     versus the traditional left-sided position.~   "
109988|NCT01616589|"~     The purpose of this research is to determine if saliva samples can be used as an alternate~     sample type to test for fragile X. By using saliva instead of blood, it would be easier for~     patients to have fragile X testing.~   "
109989|NCT01616576|"~     The purpose of this study is to compare a new sound processing strategy to the current sound~     processing strategy.~   "
109990|NCT01616563|"~     The overall objective of the CHANGE initiative is to change the delivery of care in primary~     care clinics to treat disease by reducing reliance on drugs and hospitals through the~     promotion of scientifically validated nutritional concepts and exercise. Specifically, the~     objective is to identify patients from primary care clinics with metabolic syndrome who are~     not morbidly obese and use diet and exercise interventions to reverse the changes, reduce~     reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.~   "
109991|NCT01616550|"~     The purpose of this study is to assess the quality of postoperative pain management in a~     Canadian teaching hospital following thoracic surgery.~      Hypothesis: Postoperative pain management following thoracotomy or thoracoscopy is still~     suboptimal despite the evidence that adequate pain relief improves outcome.~   "
109992|NCT01616537|"~     Background Patient satisfaction with or acceptance of care assessment is increasingly taken~     into account in oncology. Most cancer and other critically-ill patients require a~     totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a~     reservoir connected to a central venous catheter, which may or may not be valved. It is~     impossible to estimate the number of CVC used in oncology. However, some authors claim that,~     in 2005, over 7 million CVCs were placed in the United States in both chronic and acute~     care. Although many patients fitted with a CVC are able to undertake activities which are~     hindered with other external vascular access devices, they are often physically or~     psychologically anxious about their device. To our knowledge, no validated questionnaire~     measuring patient acceptance of and satisfaction with their CVC has been reported in the~     literature. Based on these observations, the aim of our study was to develop and to validate~     a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and~     Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and~     acceptance of their CVC. QASICC is designed as a multi-dimensional, self-administered~     questionnaire comprising approximately 30 items related to the use, appearance and pros and~     cons of the device as well as quality of life as perceived by patients using one for~     treatment.~      Objective The purpose of the study is to validate a French-language self-administered~     questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning~     their totally-implanted central venous catheter: confirmatory validation of questionnaire~     psychometric properties.~      Study Design This is a prospective, multicenter, open study.~      Primary Outcome Measures:~      Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:~        -  Items quality~        -  Dimensional structure~        -  Dimensional consistence~        -  Measure accuracy~        -  Measure reliability~        -  Sensitivity to change~   "
109993|NCT01616524|"~     The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon~     Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus~     Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared~     to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin~   "
109994|NCT01616511|"~     The objective of the study is to demonstrate the long-term safety and performance of the ATI~     Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in~     cluster headache subjects.~   "
109995|NCT01616498|"~     This pilot study is designed to determine the relationship between intra-myocellular lipids~     and muscle contractility in fibers from obese and non-obese older adults. Obese participants~     are being recruited for an on-going weight loss intervention study and this application~     seeks approval to recruit and enroll a lean comparison group of non-obese older adults. The~     primary goal of this study is to characterize the contractile properties of single muscle~     fibers and whole muscle in healthy, non-obese individuals under the same recording~     conditions the investigators used for the obese population to begin to determine whether fat~     infiltration accounts for diminished force.~   "
109996|NCT01616485|"~     The objective of this study is to evaluate the hemodynamic response to a sublingual dose of~     glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.~   "
110008|NCT01616329|"~     Alloantibodies can lead to serious clinical consequences and logistic problems like~     obtaining properly and timely matched blood for the patients who do develop these~     antibodies. Prevention of such serious events is possible by extended matching and typing of~     donor's blood against the patient's for all the possible antigens, but this process is~     cumbersome and costly. Identifying a high risk group will be a feasible first target for~     advanced matching a big step forward, and the aim of the investigators study. The aim of the~     project is to examine the association between clinical, environmental and genetic~     characteristics of the recipient of erythrocyte transfusions and the risk or resistance to~     immunization against erythrocyte alloantigens that he/she was exposed to during that~     transfusion episode.~   "
109997|NCT01616472|"~     The study is designed to assess the association between steroid exposure and five~     potentially steroid-related adverse events within a cohort of individuals with systemic~     lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new~     (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular~     necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The~     study will consist of five matched case-control analyses nested within the Hopkins Lupus~     Cohort. Cases will be incident SLE cases who have developed one of the case outcomes~     (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or~     avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The~     primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration~     of exposure to steroids. The extent of the risk associated with steroids will be explored~     through modeling of the relationship and through calculation of attributable risks of~     exposure (number of cases associated with the highest exposure quartile of each primary~     exposure).~   "
109998|NCT01616459|"~     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two~     formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered~     as 3-dose primary vaccination during the first 6 months of life followed by a booster dose~     in the second year of life. To comply with the routine infant immunisation program, the~     licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in~     infants with the pneumococcal study vaccines.~   "
109999|NCT01616446|"~     The purpose of this study is to evaluate whether there are differences in the~     pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed~     disease in children.~   "
110000|NCT01616433|"~     Older adults are at high risk for loss of independence because of age-related chronic health~     conditions. Of these chronic conditions, arthritis accounts for the largest proportion of~     the disability in the community. The investigators propose to target older adults who have~     self-reported arthritis or joint pain for dissemination of a disability prevention program.~     The program will be a collaborative effort of the Arthritis Foundation, the investigators~     Prevention Research Center staff and other key partners in the community. The project will~     develop information needed to provide guidance for implementation of the investigators~     intervention by other agencies and organizations. As a major thrust of the investigators CDC~     Prevention Research Center, the investigators have developed a comprehensive program focused~     on preventing disease and disability in older adults: the 10 Keys to Healthy Aging. Each~     of the 10 Keys disseminates proven approaches and current recommendations for prevention in~     older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective~     is to determine if an integrated evidence based exercise intervention (AFEP) combined with~     health education on preventive practices for older adults (10 Keys) is more effective for~     improving mobility and risk factors for mobility disability and use of preventive services~     compared to exercise alone (AFEP). The investigators will also propose to evaluate the~     impact of geographic location on outcomes and overall sustainability of the program.~   "
110001|NCT01616420|"~     The main purpose of this implementation science study is to find out if providing aPS at 18~     different Ministry of Health (MOH) VCT clinics in Kenya works and is cost-effective. This~     would enable co-investigators in the Kenyan MOH to justify funding to scale-up these~     services.~      The primary aim of the study is to find out whether providing aPS to sexual partners of~     newly tested HIV-infected individuals can result in more sexual partners getting counseled~     and HIV tested and linked to HIV care programs for initiation of ART if appropriate. The~     investigators hypothesize that aPS will increase rates of case-finding, linkages to care,~     and ART initiation and will not result in social harm.~      The second aim is whether aPS is cost-effective in the Kenyan setting. The investigators~     will estimate how much it costs (when compared to standard methods) to identify and link~     HIV-infected persons into care. The investigators will also determine how successful aPS is~     at preventing future HIV transmission events and other outcomes associated with untreated~     HIV infection. The investigators hypothesize that HIV prevalence among partners in the~     immediate aPS arm will be high enough to make this approach cost-effective from the payer~     and societal perspective.~      Finally, with the Kenya MOH, the investigators want to establish a nationwide monitoring~     system to evaluate why Kenyans are testing for HIV. In the future, when aPS is rolled out~     nationally, this will help Kenyan public health officials define the contribution of aPS to~     HIV case-finding. The investigators hypothesize that the proportion of newly tested~     HIV-infected individuals who report testing because of known exposure to a person with HIV~     will represent a significant proportion of new cases and the investigators will be able to~     identify places in Kenya where aPS will have the greatest impact on HIV treatment and~     prevention.~   "
110002|NCT01616407|"~     The purpose of this study is to assess and compare the effects of a single dose of~     3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social~     cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective~     perception for positive and impairs perception for negative emotional stimuli compared to~     placebo or MPH.~   "
110003|NCT01616394|"~     The aim of the study is to evaluate the value of postoperative troponin in the prediction of~     mid term and long term mortality and morbidity in children with congenital heart disease~     undergoing cardiac surgery.~   "
110004|NCT01616381|"~     This protocol describes a 2-arm randomised controlled pilot study assessing the tolerance,~     safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil~     will be well tolerated and efficacious in patients with chronic heart failure (NYHA class II~     and III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary~     hypertension (SPAP >40mmHg).~      Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or~     placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to~     the active therapy group and analysed for differences in the main study end-points Patient~     Global Assessment and 6-Minute Walk Test.~      The study will also assess safety, tolerability, symptoms and quality of life.~   "
110005|NCT01616368|"~     The investigators propose to study the effect of mindfulness training on the eating~     behaviors and dietary intake of overweight or obese persons. Mindfulness skills training~     involves bringing non-judgmental attention to thoughts, emotions and bodily sensations -~     including hunger and satiety cues. It is hypothesized that as subjects advance through the~     8-week class series, developing their capacity for mindfulness and in effect learn to pay~     attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating~     behaviors, that their eating behaviors will improve. Specifically, the investigators~     hypothesize that 1) there will be significant improvements in the areas of uncontrolled and~     emotional eating, 2) there will be significant decreases in total caloric intake and~     significant increases in fruits and vegetables, and 3) there will be a positive significant~     relationship between the frequency/consistency of mindfulness practice and improvements from~     baseline to follow-up measures.~   "
110010|NCT01616303|"~     This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of~     oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when~     combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line~     chemotherapy (carboplatin and paclitaxel) alone in female patients with advanced ovarian~     cancer. This study is to confirm previous results that showed oregovomab was able to help~     the body to produce an immune response to CA125 (a target that has been identified on~     ovarian cancer cells) in patients with stage III-IV ovarian cancer when they were receiving~     chemotherapy for their disease. The primary aim of the study is to see how well these~     patients with advanced ovarian cancer make an immune response to CA125 by using a specific~     test (enzyme-linked immunospot (ELISPOT) assay) of the patient's blood. The study will also~     look at the side effects of the oregovomab, other immune response parameters, how well the~     patients respond to the treatment of their disease (how long it takes to show that their~     disease has progressed and how long these patients survive overall).~   "
110011|NCT01616290|"~     The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the~     adventitia of arteries following successful angioplasty (PTA).~   "
110012|NCT01616277|"~     The purpose of this study is to determine if the study drug, PF-06252616 is safe and well~     tolerated when given to adult healthy volunteers.~   "
110013|NCT01616264|"~     Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph~     scan three-dimensional reconstruction method for the measurement of the TB pleural effusion~     volume in clinically stable patients.~   "
110014|NCT01616251|"~     Background:~        -  New Nordic diet guidelines advocate a reduction in consumption of protein from animal~          sources such as beef and pork, due to environmental concerns.~        -  Instead, intake of protein from vegetable sources such as legumes and pulses should be~          increased.~        -  A previous study showed that a meal enriched with vegetable protein increased the~          subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI)~          compared to animal protein.~        -  This study did, however, not document that vegetable protein per se is more satiating~          than animal protein as the vegetable meal had higher fiber content. Fiber is a likely~          confounder.~        -  The protein from egg is sparingly investigated in relation to appetite. Few studies~          have found that eggs have a high satiety index but further investigation is needed.~      Objective:~      - To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and~     ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg~     with similar distribution of macronutrients and content of dietary fibers.~      Design:~      Single-blind randomized 4-way crossover meal study~      Subjects:~      33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.~      End points:~        1. Subjective appetite (VAS) (every 30 min for 3 hours)~        2. Ad libitum EI (3 hours after lunch test meal)~   "
110015|NCT01616238|"~     The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to~     carry out a prospective, non randomised multi-arm study (including a choice of regimen~     intensity) to investigate the safety, tolerability and feasibility of a standardised therapy~     protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic~     standard of care upon which trials of novel therapies will be based in future. The design of~     the study will enable collection of a comprehensive dataset regarding the clinical outcome,~     Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a~     previously completely uncharacterised population, thus providing the essential platform for~     designing future randomised advanced phase studies in which new therapeutic approaches and~     novel therapies can be prospectively investigated.~   "
110016|NCT01616225|"~     This study (the Adjuvant Growth Hormone Study) is being done to see the effects of adding~     Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF).~     Growth Hormone is a protein that your body normally produces. Growth Hormone can act on~     several different organs, including the ovaries, where eggs are made. From evidence gathered~     from studies done by fertility doctors over the years, researchers believe that women who~     have not become pregnant through IVF in the past might have better results if they go on a~     course of Growth Hormone during the IVF treatment. However, more research needs to be done~     to confirm whether adding Growth Hormone is beneficial and also to find out the best time to~     start Growth Hormone treatment during IVF.~      We hope that our Adjuvant Growth Hormone study will help answer these questions.~   "
110017|NCT01616212|"~     The purpose of this study is to evaluate two brief, sustainable interventions for a sample~     of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement~     Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents.~     Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related~     offenses, treatment entry, and other areas of individual and family functioning.~      It is expected that the combined MET+PW interventions will be more effective than a~     treatment-as-usual intervention (drug education group) for adolescents with parents not~     participating in PW.~   "
110018|NCT01616199|"~     The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose~     (MTD) or recommended dose (RD) and the safety/tolerability of PX-866 in combination~     vemurafenib in patients with any advanced BRAF-mutant cancer.~      The purpose of the phase 2 portion of the study is to compare progression free survival~     (PFS), antitumor activity (response rate), disease control rate (DCR), and the safety and~     tolerability of PX-866 in combination with vemurafenib vs. vemurafenib alone in patients~     with advanced BRAF-mutant melanoma at the doses recommended from Phase 1.~   "
110019|NCT01616186|"~     This is a phase II trial that follows the completion of the phase I UCSF trial of everolimus~     and sorafenib for Renal Cell Carcinoma (RCC). This trial will be for patients who have not~     had treatment for RCC before. This trial will have 2/3 patients getting everolimus/sorafenib~     treatment and 1/3 getting sunitinib, an FDA approved RCC drug. All three drugs are approved~     for advanced RCC when used individually, the combination of everolimus and sorafenib for RCC~     is not approved by the FDA.~   "
110020|NCT01616173|"~     Patients scheduled to have foot and ankle surgery will typically receive a single shot~     sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal~     post-operative analgesic plan. The investigators are investigating the use of perineural~     dexamethasone together with local anesthetics can improve the quality of recovery for~     patients receiving sciatic nerve blocks for foot and ankle surgery.~   "
110021|NCT01616160|"~     Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp~     explant tissue in vitro.~      Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores,~     nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate~     nasal spray (MFNS) and by comparing tissue immunohistology in NP biopsies pre- and~     post-treatment withA MFNS.~      Aim 3: To characterize the molecular signature of gene mRNA expression in~     steroid-sensitive and steroid-resistant NP using microarray on NP tissue pre- and~     post-MFNS treatment.~      Hypothesis 1: Genes that regulate apoptosis are dysregulated in nasal polyp (NP)~     inflammatory cells, epithelial cells and smooth muscle actin myofibroblasts leading to~     persistence of inflammatory cell infiltration and abnormal epithelial and myofibroblast~     cellular proliferation. These can be corrected by mometasone. Apoptosis-regulating genes~     that cannot be corrected by mometasone are upregulated in steroid-resistant NP.~      Elucidation of this dysregulation may prove insightful in understanding the mechanism of~     action of mometasone in NP and identifying potential molecular targets that will increase~     steroid sensitivity or, conversely, overcome steroid resistance.~      Hypothesis 2: There is a molecular signature of gene expression in NP that signifies steroid~     sensitive NP (SS-NP). This signature is altered in steroid resistant NP (SR-NP).~      Elucidation of differences in the molecular signature of SS-NP versus SR-NP before and after~     treatment with mometasone furoate (MFNS) will provide novel insight into treatment of NP~     with steroids.~   "
110022|NCT01616147|"~     This randomized, controlled trial is proposed to study the effect, in a cohort of racially~     and ethnically diverse group of overweight and obese pregnant women, of an Intensive~     Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help~     participants achieve and maintain changes in dietary intake and physical activity habits~     compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers'~     post-delivery weight retention. The hypothesis is that the percent body fat at birth will be~     significantly less in offspring from ILI mothers than UC mothers.~   "
110023|NCT01616134|"~     Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients~     with a variety of health enhancement effects. Several in vitro studies and animal studies~     showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects.~     Several studies involving type 2 diabetes mellitus (T2DM) patients reported that~     administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar~     control effect and improvement of insulin resistance Although there is evidence to suggest~     that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG~     in healthy individuals on insulin sensitivity has not yet been established. Therefore, we~     investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean~     subjects without overt diabetes.~   "
110024|NCT01616121|"~     It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will~     develop acute heart failure during their hospitalization. Currently, the investigators have~     no reliable parameter for prediction of evolving acute heart failure in such a group of~     patients. As a result, the investigators have no way of preventing acute heart failure.~     Treatment of these patients only begins after appearance of clinical signs of acute heart~     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of~     evolving acute heart failure. This study will attempt to address whether preemptive lung~     impedance-guided therapy may prevent the development of overt acute heart failure and~     improve their clinical outcome.~   "
110025|NCT01616108|"~     This study seeks to determine if bupivacaine injection of eye muscles can make them stronger~     and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a~     condition generally termed strabismus. It seeks further to find out the different effects of~     various concentrations or formulations of bupivacaine, and whether addition of Botox to~     other eye muscles can add to the effect of bupivacaine and enhance the correction of~     strabismus.~   "
110026|NCT01616095|"~     This study is designed as a follow up study to that performed in 2005.~      In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was~     combined with in depth molecular and cellular biology analyses aimed at investigating the~     adipose tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD~     patients. Results published in (Ukropec et al., 2008)~      In this study identical endpoints will be investigated with the same methodology and within~     the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH~     therapy affects the~        -  whole body insulin sensitivity~        -  energy expenditure~        -  body fat distribution~        -  hepatic and skeletal muscle lipid content;~      as well as how it influences the adipose tissue~        -  endocrine,~        -  metabolic &~        -  inflammatory phenotypes.~      The strength of the planned study lies in the extensive whole body and adipose tissue~     phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine~     the long-term effects of rhGH replacement therapy in GHD adults.~      Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age~     BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of~     the study protocol as well as the stringency of the inclusion criteria.~      The clinical data obtained by methods of - integrated physiology would provide an excellent~     interpretation background for molecular-genetic studies at the tissue (adipose tissue) and~     cellular (adipocytes) level. Integration of the two could bring a new quality in the~     investigators understanding of metabolic derangements present in GHD, and will allow~     extending the investigators knowledge on the mechanisms of the long-term~     rhGH-therapy-induced improvement on body composition, metabolic health and the~     cardiovascular risk.~   "
110027|NCT01616082|"~     The purpose of this study is to better understand the different ways our bodies burn fat~     which may be important for obesity, diabetes, and cardiovascular disease.~   "
110028|NCT01616069|"~     This is a double blind randomization study, assessing hemodynamic response in patients who~     underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using~     intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be~     batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan~     will be assessment.~   "
110029|NCT01616056|"~     This phase II clinical trial studies how well bandage lenses work in treating patients with~     ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms~     and damage caused by eye graft versus host disease.~   "
110057|NCT01615692|"~     The purpose of this study is to evaluate leg health for one additional year in patients with~     symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic~     Syndrome (PTS) during the 2 years of follow up in the SOX Trial.~   "
110058|NCT01615679|"~     Non-interventional study to gain further information about the therapy progression in~     routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus~     will be on the improvement of the clinical global impression (CGI) in comparison to the~     outcome of randomized, controlled studies.~   "
110030|NCT01616043|"~     The healing of full thickness skin defects treated with a split thickness skin graft (STSG)~     is frequently associated with excessive scarring and contraction. The psychological burden~     of poor cosmesis of these scarred regions as well as functional problems due to skin~     tightness and decreased joint mobility cause a very significant morbidity in these patients.~     Application of a dermal substitute underneath the split skin may improve the quality of the~     scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this~     substitute it will contribute to a long term improvement of pliability and function and a~     better esthetic outcome.~      The main objective is to evaluate the difference in scar quality, after skin restoration of~     full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary~     objectives are: to evaluate the percentage of Glyaderm® take before application of~     autografts, to compare healing time and percentage of autograft survival and bacterial load~     in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct~     a concurrent cost-effectiveness and health related quality of life study (i.e. cost utility~     analysis).~      The study is an interventional, prospective, randomized and controlled interactive web~     based, study in a multicentre setting. Patients with full thickness burn wounds or full~     thickness skin defects will be evaluated before enrolment. A total of 120 patients will be~     included.~      All included patients will undergo full thickness removal of the burned skin or adequate~     debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol~     preserved allografts for wound bed preparation. At the second operation, 5-7 days after the~     first operation, the allografts are removed. If the wound bed is not suitable for grafting,~     additional wound bed preparation with allografts is required until the wound bed is~     satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the~     Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm®~     group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin~     STSG. In the control group, the wounds are immediately covered with a thin STSG.~      Up to one year after complete wound closure, patients are followed-up for scar evaluation~     and quality of life.~   "
110031|NCT01616030|"~     Patients treated surgically for a hip fracture have a need of rehabilitation for the regain~     of former functional skills. Despite an optimized fast track in-hospital rehabilitation~     program it has been found that patients with hip fracture within 2 weeks after the hip~     fracture loose more than half of their muscle strength in the fractured limb compared to~     non-fractured limb. New studies including patients with total hip arthroplasty and strength~     training applied early after surgery has shown promising results regarding prevention of~     loss of muscle strength. No similar study has been found including patients with hip~     fracture.~      The purpose of this study is to examine the feasibility of progressive knee-extension~     strength training of the hip fractured limb, starting Day 1 after surgical treatment for a~     hip fracture and proceeded every weekday during their hospital stay.~      The study will include 20 patients surgically treated for a cervical hip fracture and 20~     patients surgically treated for an intertrochanteric or subtrochanteric fracture. All~     patients are admitted from their own home. Age 60 years or older.~   "
110032|NCT01616017|"~     Cardiac output (CO) is an important hemodynamic variable in the management of critically ill~     patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential~     complications and there is increasing interest in less invasive methods of measuring CO.~     This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound~     dilution (COUD).~   "
110033|NCT01616004|"~     The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive~     effects in healthy volunteers.~   "
110034|NCT01615991|"~     Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is~     considered a reliable and easy-to-perform therapy without harmful side-effects for the~     treatment of inflammatory joint disease in many countries.~      The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide~     synovectomy are appropriate therapeutic interventions in patients with persistent active~     synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to~     systemic therapy and intra-articular corticosteroid injections.~      The primary objective will be to assess the safety of an intra-articular administration of~     Yttrium-90 citrate colloid or Rhenium-186 sulfide.~      The secondary objective will be to assess the efficacy on synovitis.~   "
110035|NCT01615978|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety after~     multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2~     diabetes.~   "
110036|NCT01615965|"~     The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes~     of patients with prostate cancer by quantitative polymerase chain reaction and its impact on~     progression-free survival.~   "
110037|NCT01615952|"~     Blockade of the brachial plexus using a supraclavicular approach provides excellent~     anesthesia for upper extremity surgery. The most serious complication specific to this block~     is pneumothorax. Subsequent modifications of this block including the use of ultrasound have~     lowered the risk from 6% to <1%. Case reports remain and authors have described certain~     factors and strategies to reduce this risk. Most texts and journals describe the patient in~     a supine or semi-sitting position during the block. At the investigators institution the~     investigators perform the block in a semi-sitting position to facilitate needle tip~     visibility with ultrasound. The investigators plan to obtain ultrasound anatomic~     measurements in three different positions (supine, semi-sitting, sitting) using patients~     consented for supraclavicular nerve blocks.~   "
110038|NCT01615939|"~     The purpose of this study is to compare the incidence of postoperative symptoms of~     neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a~     continuous infragluteal-parabiceps sciatic nerve catheter.~   "
110039|NCT01615926|"~     Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF)~     signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg~     swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight~     gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations~     every year, resulting in an enormous public health burden. Approximately 1/3rd of patients~     will either be re-hospitalized or die within three months, and the resultant financial costs~     are large. As such, improving outcomes for AHF patients is critically important. Shortness~     of breath is the most common reason why patients with AHF present to the ER. As such,~     understanding how severe this symptom is, how much it improves with current treatments is~     very important to both patients and physicians. The purpose of this study is to determine~     the degree to which your shortness of breath improves during the first few days of~     hospitalization and its association with how fast you are breathing.~   "
110040|NCT01615913|"~     This study is to explore the optimization of anti‐onychomycosis patch with various~     formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3‐mg, 6‐mg~     and 8‐mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2‐mg~     ketoconazole/patch) and its safety profile.~   "
110041|NCT01615900|"~     The main objective of this study is to optimize the coverage of renal transplant patients~     thanks to a personalized follow-up based on a risk score of early graft failure (KTFS,~     Kidney Transplant Failure Score), associated with teleconsultations.~   "
110042|NCT01615887|"~     Amphetamines have been shown to improve cognition but its use is limited due to its side~     effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been~     safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The~     investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS~     patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its~     positive effects should be observed primarily in the domains of processing speed and working~     memory. The investigators therefore propose a study in which the primary objective will be~     to assess the efficacy of lisdexamfetamine in improving attention and processing speed in~     MS. The secondary objectives will be (a) the assessment of the safety and tolerability of~     lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other~     cognitive domains, depression, and self and informant reports of cognitive and executive~     function demanding activities and behaviors.~   "
110043|NCT01615874|"~     The purpose of this study is to assess the effect of one of five possible study medications~     used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years~     with persistent asthma.~   "
110044|NCT01615861|"~     The objective of this study is to evaluate clinical outcomes following sub-2 mm~     micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study~     is evaluated in two Phases~        -  V4 (6M) endpoint: primary analysis~        -  V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis~   "
110045|NCT01615848|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine~     syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The~     elevated insulin characteristic of PCOS is likely to play a major role in its symptoms.~     restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity~     and therefore lower androgen production in women with pcos women.the purpose of this study~     is to determine which diet is more effective in improving metabolic and reproductive~     outcomes.~   "
110046|NCT01615835|"~     Use of the EnSite NavX system to map the coronary vasculature during CRT implant~   "
110047|NCT01615822|"~     OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the~     advantage of a longer elimination half-life so is being developed to be administered~     together with a potential partner drug e.g. mefloquine as a single dose cure for~     uncomplicated malaria. The study findings will be used to inform the dose and design of~     future studies. The aim of the study is to establish the safety, tolerability and~     pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum~     tolerated dose, in healthy volunteers.~   "
110048|NCT01615809|"~     The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised~     amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary~     aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive~     chemotherapy.~   "
110049|NCT01615796|"~     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of~     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive~     pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative~     pathogens associated with respiratory tract, skin and soft tissue infections including~     isolates resistant to existing classes of antimicrobials.~   "
110050|NCT01615783|"~     Reports suggest that the Medicaid population includes a higher percentage of smokers than~     the general population. A high prevalence of smokers in a population is likely to lead to a~     higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated~     the economic burden of COPD in a Medicaid population. The objective of this observational,~     retrospective cohort study is to estimate the economic burden of COPD in subjects with a~     COPD diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered~     by Medicaid.~      Specifically, the null hypothesis for the primary outcome measure is that no difference is~     observed in all-cause costs between subjects with and without COPD. The test hypothesis is~     that there is a difference in all-cause costs between subjects with and without COPD.~      Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for~     the COPD cohort.~      The study uses a medical and pharmacy administrative claims database called MarketScan~     Medicaid Database that contains the medical, surgical, and prescription drug experience of~     nearly 7 million Medicaid recipients. This analysis will use data from 8 states.~   "
110051|NCT01615770|"~     Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment~     strategy in promoting longer-term smoking abstinence. The investigators will also conduct~     secondary analyses of mediators and moderators of treatment response.~   "
110052|NCT01615757|"~     The study will be conducted in the Department of Medical Oncology and Department of~     Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in~     complete remission after induction chemotherapy will be enrolled into the study and will be~     further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3~     cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study~     protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the~     relapse free survival and overall survival as well as time to relapse and toxicity~     /treatment related morbidity.~   "
110053|NCT01615744|"~     Between 1994-98 5 hospitals in Stockholm investigated calcaneal fractures in a randomised~     study.~      82 patients were included and randomized either to non-surgical treatment or surgical~     management with extensile lateral approach and reduction with Internal fixation (ORIF) The~     patients were followed and investigated at fixed intervals 2 weeks, 8 weeks, 3 months and 6~     months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury.~      Both clinical radiological data were collected and several scores were used. The primary~     outcomes scores used were SF-36 and VAS score.~      The results after 1 year and mean 10 years are presented.~   "
110054|NCT01615731|"~     A common practice for preparation for surgical abortion after 19 weeks gestation is the~     placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The~     investigators aim to study the addition of mifepristone as an adjunct to cervical dilation~     prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of~     painful procedures and time in clinic (or away from work/home) that multiple sets of~     dilators can require. The investigators hypothesize that one set of dilators with~     mifepristone will result in similar procedure times and decreased total time as two sets~     of dilators.~   "
110059|NCT01615666|"~     The purpose of this study is to use a functional MRI (fMRI) index to compare the brain~     activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and~     Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for~     Alzheimer's disease.~      The study hypotheses are:~        1. The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's~          dementia, and healthy volunteers;~        2. The fMRI index will distinguish participants with MCI who convert to Alzheimer's~          disease from those who convert to a non-Alzheimer's dementia and those who remain~          stable;~        3. MCI participants with a lower fMRI index at baseline who convert will progress to~          Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a~          faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's~          disease.~   "
110060|NCT01615653|"~     -  Hypothesis:~           - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the~          efficacy of neurolysis and subsequent pain control and survival in patients with~          pancreatic carcinoma.~        -  Rationale:~             -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal~               thereby only briefly remaining in contact with neural structures and limiting the~               degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result~               in diminished neurolysis and decrease efficacy.~   "
110061|NCT01615640|"~     The aim of the study is to assess the accuracy of dynamic contrast enhanced and~     diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.~   "
110062|NCT01615627|"~     The investigators will test whether hypotonic (diluted) remodulin solution causes less pain~     than the eutonic (undiluted) solution supplied by the manufacturer.~   "
110063|NCT01615614|"~     The purpose of this study is to explore the pharmacokinetics of different dosing regimens of~     rilpivirine in combination with rifabutin in healthy participants.~   "
110064|NCT01615601|"~     The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine~     (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are~     naïve to these medications and in patients who have experienced tolerability issues on their~     current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by~     switching the patients from their previous or current combination antiretroviral therapy~     (cART) to either darunavir or etravirine.~   "
110065|NCT01615588|"~     Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different~     geographical locales around the North Island of New Zealand and tested for glycaemic index~     (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed~     honey containing 25g of available carbohydrate in 200 ml water and the blood glucose~     responses measured (area under the curve; AUC) and compared to that of 25 g of available~     carbohydrate from glucose.~   "
110066|NCT01615575|"~     The aim of the present study was to compare the results of transanal haemorrhoidal~     dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV~     haemorrhoids with a long-term follow-up.~   "
110067|NCT01615562|"~     The purpose of this study is to determine if changes in blood vessel health lead to the~     menstrual irregularities that women with PCOS experience. This research study will help~     determine if women with PCOS have early changes in their blood vessels called endothelial~     dysfunction, and if the number of progenitor cells (cells that in a healthy person repair~     blood vessel damage) are related to these blood vessel changes. To do so, we will compare~     ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood~     tests between women with PCOS and other healthy women with normal menstrual periods.~   "
110068|NCT01615549|"~     Virtual reality devices are widely accepted tools to familiarize surgical novices with the~     principles of laparoscopy. Free Virtual reality training will be tested against basic~     training and efficacy assessed in a randomized controlled trial of surgical novices.~   "
110069|NCT01615536|"~     The hypothesis of this study is that canine fossa trephination (CFT) improves surgical~     outcomes for patients with a severely diseased maxillary sinus.~   "
110070|NCT01615523|"~     Hd-EEG and MRI measures are used to study the maturation of functional networks in order to~     identify the neural circuits underlying executive and memory processes in children born~     preterm. It will be determined whether children born preterm with executive function~     deficits will have an abnormal connectivity between basal ganglia and cortex due to WM~     injury. Moreover, the development of hd-EEG activity during sleep (coherence and travelling~     waves) and brain maturation of children and adolescents born preterm will be compared with~     the respective measures in healthy controls. This is of eminent importance as it helps to~     understand the nature of executive function and hence, it may help to develop~     neuroprotective strategies to prevent executive function deficits in these infants.~   "
110071|NCT01615510|"~     MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation~     besides effectively reducing pain intensity in pain. Human pain surrogate models can serve~     in this proof-of-concept study to further elucidate this assumption.~   "
110072|NCT01615497|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically~     designed for alcohol to evaluate its effectiveness relative to standard outpatient~     counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program~     (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of~     coping skills in a number of realistic situations in video form, and providing opportunities~     for patients to practice and review new skills while receiving substance abuse treatment.~   "
110073|NCT01615484|"~     The purpose of this research study is to learn about the safety of transplanting lungs~     obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a~     breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion~     solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done~     outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device~     used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and~     ventilation is to learn how well the lungs work, and whether they are likely safe to~     transplant.~   "
110115|NCT01614912|"~     The study evaluates the long term safety and efficacy of SM-13496 in patients with~     schizophrenia.~   "
110074|NCT01615471|"~     The Lose Now NC research study aims to determine feasibility by delivering a community based~     weight loss program for 4 months in Kannapolis, NC in a large group format compared with~     smaller group format, (recruiting approximately 225 participants from Mecklenburg and~     Cabarrus counties and randomizing them to large or small group in-person sessions coupled~     with an interim internet program) to examine reach and recruitment potential, pilot~     intervention procedures, collect process measures to determine satisfaction, adherence,~     attrition, and estimate weight loss for planning a larger trial.~   "
110075|NCT01615458|"~     This study will determine if a version of the chronic care model for individuals with mood~     disorders can improve patient health.~   "
110076|NCT01615445|"~     Previous animal studies have found that resveratrol supplementation significantly increased~     aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over~     study to assess whether resveratrol could provide similar benefits in humans.~      All participants were assigned to two 4-week treatment periods, with a 2 week washout~     in-between. During one period, volunteers in received resveratrol and during the other~     period, they received identical-appearing placebo.~      The primary outcome of interest was change in exercise capacity, as measured by change in~     exercise duration on constant load exercise testing and change in aerobic capacity (peak~     VO2) on incremental exercise testing. Secondary outcomes were tolerability and side-effects~     associated with resveratrol.~   "
110077|NCT01615432|"~     Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2~     ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients~     admitted in the intensive care unit for respiratory failure and treated with NIV.~   "
110078|NCT01615419|"~     This multi-center, observational study will evaluate the use in clinical practice and~     efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible~     patients initiated on RoActemra/Actemra treatment according to the approved label will be~     followed for 6 months.~   "
110079|NCT01615406|"~     This is a single arm, open label study of up to 24 prostate cancer patients scheduled for~     prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of~     99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard~     of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND)~     within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for~     visible uptake and compared with histopathology.~   "
110080|NCT01615393|"~     This prospective, randomized, single-blind, cross-over study will compare the~     bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as~     capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of~     400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will~     be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.~   "
110081|NCT01615380|"~     Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer~     and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be~     an efficacious treatment component in combating nicotine dependence, especially among women~     for whom concerns about weight gain during smoking cessation are an obstacle to successful~     quitting. In previous trials of women smokers, the investigators program of cognitive~     behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more~     efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to~     Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental~     Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the~     Commit to Quit program is well poised for a larger trial in a community setting where it has~     the potential to reach a large number of female smokers in a setting in which it can be~     sustained. In response to PA-03-126, Behavioral Therapies Development Program, the~     investigators propose a Stage III study in which they will conduct a trial to test the~     investigators CTQ smoking cessation program in the community setting of the local YMCAs. As~     stated in the PA, Stage III research is aimed at understanding if and how an efficacious~     therapy may be transported to the community. The investigators propose a randomized~     controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The~     trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT~     smoking cessation treatment plus contact control. In order to promote transportability to~     the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is~     similar to the investigators CTQ exercise program, in that it is guided by trained staff and~     requires participants to exercise 3 times per week. If the exercise condition is found to be~     more efficacious than contact control when delivered at the YMCA by YMCA staff, then the~     investigators will be well positioned to partner with the YMCA to pursue widespread,~     national dissemination of this program.~   "
110082|NCT01615367|"~     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar~     disorder, yet no empirically validated psychosocial interventions to manage risk factors for~     CVD in BD have been developed. The purpose of this study is to develop and test the~     feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether~     the intervention improves overall functioning and mood symptoms. The designed treatment~     integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment~     (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx~     includes novel intervention strategies in each of these three modules, as well as modified~     and tailored empirically-supported strategies for bipolar disorder. The primary hypotheses~     are that NEW Tx will be feasible to deliver, acceptable to this population, and associated~     with improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will~     examine predictors of treatment response and the effect of NEW Tx on mood symptoms and~     overall functioning.~   "
110083|NCT01615354|"~     This randomized, double-blind, placebo-controlled, cross-over study will assess the effect~     of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy~     volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the~     other period volunteers will receive placebo.~   "
110084|NCT01615341|"~     Chronic allograft injury is the leading cause of graft loss in renal transplantation. The~     shortage of available kidneys for transplantation has reached crisis levels with increasing~     numbers of waiting list mortalities. Strategies to prolong graft survival are urgently~     needed. The pediatric and young adult transplant population is one in which repeat~     transplantation is inevitable and therefore, this group is one who will especially benefit~     from intervention to prolong graft survival. The hypothesis of this proposal is that~     subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic~     allograft injury. The young age of the proposed study population is an ideal one to evaluate~     this objective due to the high prevalence of seronegative recipients. The studies outlined~     will determine the temporal relationship betWeween subclinical viremia, renal allograft~     infection and allograft injury. This will be the first prospective study in renal transplant~     recipients to systematically monitor subclinical viral infection both in peripheral blood~     and in the renal allograft with concurrent quantitative measures of renal function,~     allograft fibrosis, and innate immune activation. The investigators have chosen these 3~     outcomes because they evaluate a spectrum of renal allograft injury and represent different~     stages - from early to late - in the pathophysiology that leads to renal allograft~     dysfunction. In addition, the role of virus specific T cell immune responses in the control~     of subclinical viral infection and associated allograft injury will be determined. These~     data are critical as they will provide insights into the pathogenesis of injury and will~     guide development of interventions strategies. Importantly, the current treatment strategies~     for viral disease do not prevent subclinical viral infection. Thus, the results of this~     study may identify that prevention, prophylaxis and/or treatment of subclinical viral~     replication as a long term strategy to prevent chronic allograft injury and prolong graft~     survival.~   "
110085|NCT01615328|"~     Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a~     variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical~     spondylotic radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using~     autogenous iliac bone graft is gold standard, however, it may lead to donor-site~     morbidities. Preventing these complications, some authors have tried to use alterative bone~     graft substitutes. Among these alternatives, Cervios ChronOs™ which is the~     polyetheretherketone (PEEK) cage with b-tricalcium phosphate (TCP) has become popular and~     shown good clinical results. However, b-TCP has only osteoconduction ability of three~     osteogenic properties.~      Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized~     bone matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and~     osteoinduction, therefore this alternative is expected to show superior bone fusion~     capability to PEEK cage with b-TCP. However, there has been no comparison study between the~     PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate~     bone fusion rate between these cervical spine cages using postoperative computed tomography~     (CT)~   "
110086|NCT01615315|"~     Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin~     treatment and hematuria in general population is not well known. The investigators will~     evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy~     large screened populations.~   "
110087|NCT01615302|"~     Rationale:~      Closure of the internal opening is the most accepted standard procedure in the treatment of~     peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one~     out of the three patients mucosal flap repair fails. Possible causal factors are incomplete~     clearance of pus and debris, incomplete closure of the internal opening, inappropriate host~     response in patients with risk factors like smoking or diabetes. Platelet derived growth~     factors may facilitate closure of the internal opening, especially in patients with impaired~     wound healing.~      Objective:~      The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal~     advancement flap to achieve a better closure rate of complex peri-anal fistula's.~      Study design:~      Randomized, multicenter trial.~      Study population:~      Patients with complex cryptoglandular peri-anal fistula's.~      Intervention:~      Injection of PRP in the curretted fistula track under the mucosal flap.~      Main study parameters/endpoints:~        -  Recurrence rate~        -  Post-operative pain~        -  Continence~        -  Quality of life.~      Nature and extent of the burden and risks associated with participation, group relatedness:~      Because autologous blood is used, no extra risk are expected.~   "
110088|NCT01615289|"~     Green tea is being recognized as a beverage with potential benefits for human health and on~     cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea~     intake may play a positive role in improving effects on cognitive functions. The~     investigators aim to examine the neural effects of green tea extract on brain activation in~     humans.~   "
110089|NCT01615276|"~     In the present study, the effect of a bolus of intrinsically labeled milk directly after~     one-legged NMES will be studied.~   "
110090|NCT01615263|"~     Lung isolation is frequently used during thoracic surgery. Two techniques are principally~     used: the double lumen tube (DLT) and the bronchial blocker (BB). BB is easy to use but its~     reputation is darken by the need of multiple repositioning during surgery and especially by~     a slower lung collapse than the DLT. Reading recent literature on the subject and according~     to the vast experience of numerous hospital centers, it seems that the slowness of lung~     collapse remains without any solution. This slowness in lung deflation is detrimental to the~     initiation of video-assisted thoracoscopy surgery (VATS) and could be exacerbated in chronic~     obstructive disease (COPD) patients. For this reason, BB use is discredited in numerous~     centers. However, at IUCPQ, the investigators rarely observe slow lung collapse when BB are~     used. For many years, the investigators have used a systematic denitrogenation of the lung~     before the initiation of one lung ventilation (OLV). Furthermore, when the patient is~     positioned in lateral decubitus, the investigators impose an apnea period of about 30~     seconds to favor collapse of the isolated lung before inflating the cuff. This apnea is~     always limited by the occurrence of oxygen desaturation (≤97%). The investigators also~     proceed to a second period of apnea of 30 seconds associated to a deflated BB's cuff at the~     pleural opening. Subsequently, the investigators inflate the BB's cuff to obtain definitive~     lung isolation. The investigators hypothesis is that the use of two apnea periods, when~     isolating the lung with a BB, will allow the same quality of surgical exposure at 0, 5, 10~     and 20 minutes post opening of the pleura, compared to the one obtained with a DLT. The main~     objective of this study is first to compare the delay between the initiation of OLV and~     complete lung collapse obtained with BB and DLT, in two groups of patients undergoing VATS.~     Secondary objectives are: 1) to evaluate the quality of surgical exposure associated to the~     level of lung collapse, 2) to evaluate the quality of surgical exposure through the video~     camera, 3) to collect surgeons' opinion regarding the device (BB or DLT) that they thought~     was used during surgery. After obtaining institutional review board (IRB) approval, the~     investigators propose a study of 40 patients undergoing an elective VATS at the Institut~     universitaire de cardiologie et pneumologie de Québec (IUCPQ) involving an one lung~     ventilation. They will have to be 18 years old or more, to read, understand and sign an~     informed consent at their pre-operative evaluation. This study will be prospective,~     randomized, and blind to thoracic surgeons.~   "
110091|NCT01615250|"~     This is a randomized study of efficiency and safety of intramyocardial implantation of~     peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with~     myocardial ischemia after preparatory course of shock - wave therapy.~   "
110092|NCT01615237|"~     System level strategies for implementing tobacco use treatment guidelines exist but are~     insufficiently put into practice, particularly in dental care settings. Closing the gap~     between research and practice is stymied by the limited research on systems changes~     necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning~     dissemination science literature, the proposed study compares the cumulative benefit of the~     following three systems-level strategies: 1) staff training and clinical reminders, 2)~     provider feedback and 3) pay-for- performance (financial incentives), that have been widely~     endorsed by a 2001 Institute of Medicine Report, Crossing the Quality Chasm (IOM 2011) and~     the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).~      The investigators propose a 3-arm cluster randomized controlled trial that will analyze the~     implementation process and compare the cost and effectiveness of three implementation~     strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider~     performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for~     tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory~     of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the~     investigators will identify multi-level factors that facilitate or impede the implementation~     process in dental clinics. Our primary outcome is improvement in provider delivery of~     tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an~     essential determinant of patient cessation outcomes. Our secondary outcome will be~     post-intervention patient-reported quit rates. In addition to examining the comparative~     effectiveness of the three implementation strategies, the investigators will use a mixed~     methods approach to examine implementation processes (Aim 2) to assess the degree to which~     the interventions are integrated into practice as intended and to clarify the mechanisms~     through which the intervention influences provider behavior.~   "
110116|NCT01614899|"~     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients~     with schizophrenia.~   "
110117|NCT01614886|"~     To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step~     titration of Rivastigmine patch in the Japanese population.~   "
110093|NCT01615224|"~     Missed abortion is a condition where the fetus has perished but the miscarriage is not~     expelled. Women often present at a routine ultrasound or with a slight brownish discharge.~     Traditionally this condition has been treated with curettage or vacuum aspiration. Lately,~     medical treatment has become more common due to less risk of infection and other~     complications. The routine medical treatment is 800mcg of misoprostol administered~     vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial~     800mcg vaginal misoprostol increases efficacy of the treatment.~   "
110094|NCT01615211|"~     In menstruation an effective shedding of the endometrial lining occurs. Both progesterone~     and estrogen levels fall sharply at this time. During medical abortion the endometrial~     shedding is sometimes ineffective causing an incomplete abortion which may cause prolonged~     bleeding or require surgical intervention. In medical abortion a progesterone antagonist is~     used as treatment but the estrogen levels are not targeted. The investigators wish to~     explore whether addition of letrozole or trilostane which target estrogen levels can lead to~     a more effective shedding of the endometrial lining.~   "
110095|NCT01615198|"~     The purpose of this study is to access the efficacy and safety of LCZ696 compared to~     olmesartan in elderly Asian patients for the treatment of hypertension.~   "
110096|NCT01615185|"~     Background: Surveys have shown that antipsychotic drug combinations are frequently~     prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of~     extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the~     study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d~     amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of~     schizophrenia.~      Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are~     randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800~     mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety,~     but different cost.~   "
110097|NCT01615172|"~     Comparision of two different cannulation techniques on the neurological outcome in cardiac~     surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce~     neurolocical side effects.~   "
110098|NCT01615159|"~     The overall objective of this study is to assist the general public in achieving and~     maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium~     intervention that emphasizes spices and herbs. The investigators hypothesize that after four~     weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium~     intake of 1500 mg/day and their taste preferences will change. The investigators also~     hypothesize that individuals in a low sodium behavioral intervention will maintain greater~     adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed~     control group.~   "
110099|NCT01615146|"~     As a result of the underlying disease or its therapy, it is common for patients with blood~     cancers to have low platelet counts. While platelet transfusions may be beneficial in~     preventing or treating bleeding symptoms, in circumstances where the risk of bleeding is low~     they may be unnecessary or even harmful. As a blood product, transfusion of platelets may be~     associated with infectious or allergic complications, and frequent hospital visits for~     transfusion may adversely affect quality of life. Additionally, the potentially overuse of~     platelet products places a burden on health care resources.~      The benefit of the current practice of prophylactic platelet transfusions to prevent~     hemorrhage is unknown. The randomized data that exists is more than 25 years old and not~     informative given methodological limitations and the changing standards of supportive care.~     An alternative, therapeutic, strategy involves only administering platelets to control~     active bleeding.~      The standard of practice in inpatients receiving high dose chemotherapy (either for acute~     leukemia or as part of stem cell transplantation) is prophylactic platelet transfusions. In~     outpatients not receiving high dose chemotherapy, the risk of bleeding is significantly~     lower. No randomized trials have examined the optimal platelet transfusion strategy in~     outpatients with blood cancers undergoing supportive or palliative therapy. Thus the~     potential benefit of prophylactic transfusions in the outpatient setting is unknown.~      The investigators propose to perform a pilot randomized controlled trial to determine if a~     larger trial is possible. The ultimate goal is to determine if a strategy of therapeutic~     platelet transfusions is safe and effective in outpatients with blood cancers and low~     platelet counts.~   "
110100|NCT01615120|"~     Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum~     prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic~     Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with~     luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy.~     This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.~   "
110101|NCT01615107|"~     The paucity of published data concerning the issue of mechanical labor induction in the~     setting of Term PROM has led us to undertake the present clinical trial. This study is~     designed to compare the efficacy and safety of the standard Oxytocin induction protocol with~     the double-balloon catheter device with concurrent oxytocin administration in patients with~     Term PROM and unfavorable cervical conditions.~   "
110102|NCT01615094|"~     The study is designed to find out more about how mood and the nervous system affect the~     body's immune system. The investigators plan to study this in people who have been~     identified by their physician as being at-risk for the development of heart failure. There~     will be approximately 525 individuals participating in this study at UCSD and at the VASDHS.~     Individuals who will be asked to take part in this study will have a functional or~     structural heart problem apparent on an echocardiogram, or a previous heart attack, but no~     symptoms of heart failure. Some individuals will only complete one assessment (consisting of~     psychological questionnaires and interview, walk test, blood draw, and body measurements),~     whereas others deemed high-risk on the basis of a laboratory test, will be asked to~     complete that same assessment every 6 months for the duration of the study.~   "
110118|NCT01614873|"~     Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical~     ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory~     Assist)~   "
110172|NCT01614171|"~     Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of~     childhood osteoporosis and congenital blindness for which new treatments are needed. We have~     found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that~     growth hormone therapy will improve muscle mass and bone strength in OPPG.~   "
110103|NCT01615081|"~     Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with~     other composition and amount of carbohydrates could be of interest in order to decrease the~     glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a~     sweet flavor but contains a different composition and amount of carbohydrates together with~     a small amount of protein compared to sucrose. Malt extract may therefore be a better~     alternative than sucrose as a sweetener due to a lower increase and more sustained blood~     glucose level. This could be of interest in relation to diabetes and appetite regulation but~     this is yet to be investigated.~      Thus the objective is to investigate the effect of malt extract vs. sucrose on:~        1. 3-hour change in the concentration of glucose and insulin~        2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)~        3. Ad libitum energy intake~      Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The~     test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and~     sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be~     assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch~   "
110104|NCT01615068|"~     This multi-center, prospective observational study will evaluate the treatment patterns, and~     the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible~     patients will have an initial metastatic breast cancer diagnosis that has not been~     previously treated with systemic therapy; patients may be enrolled up to 6 months after the~     diagnosis. Data will be collected for up to 8 years.~   "
110105|NCT01615055|"~     Many cancer survivors are experiencing problems with memory and other cognitive abilities~     following cancer treatment. Little is known concerning the contributions of potentially~     preventive therapies on cognitive function, but animal studies have pointed to the potential~     value of the medication fluoxetine in this context. We aim to determine whether six months~     of fluoxetine therapy can preserve brain function in patients who have undergone~     chemotherapy, and examine potential biological mechanisms for its protective effects in~     humans. If use of fluoxetine in cancer patients can be validated in this manner, it will~     represent the first drug demonstrated to prevent cerebral dysfunction associated with~     exposure to chemotherapy. Moreover, as this involves an agent that is already FDA-cleared~     for other indications, widely commercially available throughout the U.S. and other parts of~     the world, and relatively inexpensive since it is obtainable in generic formulations, it~     would represent a pharmacologic approach that is amenable to rapid translation to the~     clinical setting.~   "
110106|NCT01615042|"~     Lenalidomide is a drug that alters the immune system and it may also be directly toxic to~     tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly~     kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast~     cells in preparation for a bone transplant.~   "
110107|NCT01615029|"~     The purpose of this study is to establish the safety profile of daratumumab when given in~     combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed~     and refractory Multiple Myeloma (MM).~   "
110108|NCT01615016|"~     The lungs of infants born too early are extremely underdeveloped. Respiratory Distress~     Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks~     early and leads to the collapse of their lungs. Because the lungs had not had enough time to~     mature, they lack a substance, called surfactant that prevents their collapse. To treat this~     problem, physicians apply surfactant to the lungs within the first few hours of life by way~     of the infant's airway using mechanical stimulation (ventilation). Although this treatment~     has significantly decreased the number of infants who die from RDS, the mechanical~     ventilation can cause damage to the tiny lungs that may lead to long term lung disease and~     breathing problems.~      The need for more gentle and less invasive methods of deliver the surfactant to the infant~     has led to the development of two new methods that require little or no mechanical~     ventilation. While both methods are known to work there is no study that has assessed~     whether one method is better than the other or causes fewer complications for the infant.~     The proposed study will determine if it is practical to conduct a clinical trial to compare~     both methods of surfactant administration and to gather preliminary data on which method~     gives better results. Should this study look promising, the resulting data will be used to~     design a larger clinical trial to compare the methods of mechanical ventilation. Results of~     such a trial would help us to understand the best way to administer surfactant to preterm~     infants and thus help doctors to better care for tiny infants at risk of lung disease.~   "
110109|NCT01615003|"~     In this study, typical cases of blood stasis syndrome of coronary heart disease are~     selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to~     filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile,~     intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of~     Coronary Heart disease.~   "
110110|NCT01614990|"~     The purpose of this study is to evaluate the safety and efficacy of repeated oral~     administration of macimorelin at different doses daily for 1 week for the treatment of~     cancer cachexia.~   "
110111|NCT01614977|"~     Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections~     of lymph nodes in the neck and face of otherwise healthy children.~      There are currently 3 strategies to manage these infections. Yet, all are not ideal and~     each has downsides.~        1. Surgery: removal of the affected lymph nodes is the most common approach but has the~          disadvantages of potential facial nerve paralysis, the possibility of recurrent~          infection that would require another operation and resolution with a cosmetically~          disturbing scar.~        2. Antibiotics: The antibiotic courses are prolonged and are associated frequently with~          adverse reactions. It is unclear if this treatment has a significant effect on the~          natural resolution process of the infection.~        3. Observation: follow-up the healing process without intervention. However the resolution~          may last a long period of time even more than a year. In almost all cases there will be~          spontaneous discharge of pus from the involved lymph nodes onto the skin that may last~          a few days. Later on a scar will form that may also be disturbing cosmetically.~      The inflammatory response of the body to infections may occasionally be severe. As a matter~     of fact its harmful consequences can be sometimes more serious than those of the bacteria~     that cause the infection. Prednisone and other anti inflammatory drugs have properties that~     could possibly prevent this.~      There is medical experience in using prednisone and similar drugs in addition to antibiotics~     in infectious diseases to decrease the inflammatory response against the infection. One of~     these infections is tuberculosis. The tuberculous bacteria have some common features with~     the nontuberculous mycobacteria. The investigators believe that the inflammatory process in~     infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge~     from the skin which later leads to the formation of a scar and to the prolonged resolution~     from the infection. Thus in order to hasten the resolution and to avoid formation of a neck~     or facial scar with its cosmetic consequences we suggest the use of prednisone in treating~     nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the~     inflammatory process as well as the immunity response, we chose to study the effect of~     prednisone combined with antibiotics (as the later will help to overcome the bacteria).~      The purpose of the study is to determine whether the addition of prednisone to antibiotic~     treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of~     children can hasten the resolution process and improve its cosmetic results.~      The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence~     of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained~     from the involved lymph nodes by fine needle aspiration.~      Generally healthy children with evidence of infection will be offered to participate in the~     study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:~        1. Antibiotics (2 types) and prednisone.~        2. Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but~          does not have any medical effect).~      Prednisone will be given in a dose that will decrease into half twice: after 2 and after~     four weeks.~      Follow-up visits for monitoring the inflammatory process and its resolution as well as~     adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after~     beginning therapy,~      Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests~     will be also taken at the first follow-up visit.~      A photo of the face neck and the site of the involved lymph nodes will be taken before~     starting therapy and at each of the follow-up visit.~   "
110112|NCT01614964|"~     This is an initial efficacy study of a candidate antimalarial in human subjects with~     uncomplicated malaria caused by the most common and most important parasite in Africa~     (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P.~     falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug~     (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem~     twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly~     effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both~     chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of~     Orphan Product Development (OOPD).~   "
110113|NCT01614951|"~     The purpose of this study is to investigate whether patients with a preoperative reduced~     pulmonary function have a better preserved oxygenation capacity after open heart surgery,~     using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group~     with standard ECC (Extra Corporal Circulation).~   "
110114|NCT01614938|"~     The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin~     neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly~     cisplatin in locally advanced nasopharyngeal carcinoma.~   "
110119|NCT01614860|"~     Post-discharge mortality and re-hospitalization for acute heart failure (AHF) affects 15%~     and 30% of patients respectively, within 90 days. With over 1 million annual~     hospitalizations and a financial cost exceeding 20 billion dollars, AHF is a major public~     health burden. Yet no AHF therapy to date definitively reduces morbidity and mortality, and~     in stark contrast to heart attack patients, highly rated evidence in guidelines do not~     exist. Although AHF is a syndrome and not one disease, typical treatment of patients~     hospitalized with AHF suggests otherwise. Despite substantial differences among AHF~     patients, therapy is largely uniform; patients receive medicine to help get rid of excess~     volume and little else. Although decades of empirical use support the symptomatic benefits~     of traditional therapies, outcomes remain extremely poor. As opposed to the~     one-size-fits-all‟ approach used unsuccessfully to date in clinical trials, identification~     of specific AHF patient sub-groups is critical, so that tailored therapies can be developed~     and tested. Preliminary data suggests that the neurohormone aldosterone may be detrimental~     in AHF patients. Furthermore, this hormone level appears to rise during hospitalization. The~     investigators therefore propose to identify specific AHF patient phenotypes associated with~     high serum aldosterone levels to subsequently address the hypothesis that early aldosterone~     blockade continued throughout hospitalization will decrease re-hospitalization and~     mortality. Specifically, the investigators hypothesize that AHF patients with elevated serum~     aldosterone levels have a distinct phenotype compared to those with lower or normal~     aldosterone levels. Specifically, they will be older, have a lower systolic blood pressure,~     lower EF, worse renal function, higher BNP, and previous hospitalization for HF.~   "
110120|NCT01614847|"~     Background:~      Osmolarity is defined as the concentration of particles dissolved in a solution. Normal~     tears contain various dissolved particles including proteins, salts and other electrolytes.~     The investigators plan to investigate how osmolarity of the tear film changes over time~     after instillation of artificial tears containing hyaluronate. This is one kind of~     artificial tear that is used to treat dry eye.~      Dry eye and tear osmolarity:~      Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and~     ineffective. There has been a resurgence of interest and research in dry eye in the past 5~     years, and tear osmolarity has emerged as perhaps, one of the most effective ways to~     evaluate tear quality and dry eye status. Dry eye is usually treated with artificial tears,~     and many formulations are available. The investigators will test an isotonic solution that~     contains hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.~      Objective:~      We plan to study the time course of possible changes in tear film osmolarity following~     instillation of an isotonic artificial tear containing hyaluronate. The investigators will~     use the TearLab, a new clinical instrument that has been developed to quickly and easily~     measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity~     over time can help doctors determine efficacy and dosing schedules. The investigators will~     test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline~     solution.~      Hypothesis:~      The investigators should be able to measure a decrease in tear osmolarity over time~     following instillation due to the water-binding effect of hyaluronate artificial tears~     relative to a control (normal saline solution).~   "
110121|NCT01614834|"~     The aim of this study is to validate a previously developed patient reported outcome~     instrument (in project UCT-D) to assess disease control in chronic urticaria patients~     (Urticaria Control Test - UCT) of age 12 and older.~   "
110122|NCT01614821|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in~     treating a specific cancer. Investigational means that PCI-32765 is still being studied~     and that research doctors are trying to find out more about it-such as the safest dose to~     use, the side effects it may cause, and if PCI-32765 is effective for treating different~     types of cancer. It also means that the FDA has not yet approved PCI-32765 for use in~     patients, including people with Waldenstrom's Macroglobulinemia.~      PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.~     PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell~     receptor (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk~     protein, which then results in malignant cell death. This drug has been used in laboratory~     experiments and other research studies in B-cell malignancies and information from those~     other research studies suggests that PCI-32765 may be a treatment strategy for B-cell~     malignancies, including Waldenstrom's Macroglobulinemia.~      In this research study, the investigators are testing the safety and efficacy of PCI-32765~     as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.~   "
110123|NCT01614808|"~     This research study is looking at biomarkers in urine samples from patients with Wilms~     tumor. Studying samples of urine from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients will respond to treatment~   "
110124|NCT01614795|"~     This phase II trial studies how well cixutumumab and temsirolimus work in treating patients~     with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.~   "
110125|NCT01614782|"~     The purpose of this study is to assess the multiple rising dose safety/tolerability and~     pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and~     overweight/obese participants with Type 2 diabetes mellitus (T2DM).~   "
110126|NCT01614769|"~     This study aims to assess how glimepiride affects the recovery from hypoglycemia in~     participants with type 2 diabetes mellitus. The primary objective is to estimate the time~     taken by participants to recover from hypoglycemia to euglycemia after treatment with either~     2 mg or 4 mg of glimepiride when compared to placebo.~   "
110127|NCT01614756|"~     The purpose of the study is to determine safety and tolerability of IL-31 mAB~   "
110186|NCT01613989|"~     Computer assistance in prosthetic hip surgery is able to improve the accuracy of the~     surgery: Associating hip navigation and EOSTM imaging pre-operatively could simplify the~     procedure of hip navigation in lateral decubitus while maintaining the accuracy of the~     technique~   "
110128|NCT01614743|"~     This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy~     and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients~     with rosacea.~      The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the~     cheek area. Upon study entry, subjects will be randomized to receive treatment with~     incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be~     prepared by an unblinded designee and both Physician Investigator (PI) and subject will~     remain blinded for the duration of the study. At the 16 week visit, control subjects will~     enter the rescue arm portion of the study and all study subjects will receive treatment with~     incobotulinumtoxinA to the cheek areas.~   "
110129|NCT01614730|"~     This user evaluation study is to verify that the Modified Neurotech Vital Device does not~     stimulate the pelvic floor muscles compared with the Neurotech Vital Device.~   "
110130|NCT01614717|"~     This investigation is a prospective, randomized, single-blinded and multicenter design.~      The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular~     (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients~     with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac~     Resynchronization Therapy - Pacing (CRT-P) device.~      Randomization~        -  Implant will be performed (CRT-P).~        -  Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular~          (DDD) pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12~          months:~        -  Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing~        -  Control Group. The patient´s device is programmed to back-up pacing AAI.~        -  After 12 months, the patients initially randomized to the Treatment Group (Optimized~          DDD Pacing) will continue in the same group. The patients initially randomized to~          Control Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized~          DDD Pacing). And all the patients will be followed 12 months more.~   "
110131|NCT01614704|"~     Per year, 52 000 women have breast cancer.7% are less than 40, and 2% are between 25 and 35.~     Most of them will be treated with chemotherapy.~      One of the side effects is impact on the fertility. On 06/08/04 law basis, each patient is~     allowed to preserve gametes or germinal tissues when medical care potentially affect~     fertility.~      Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols,~     provide fertility information, and help individualize fertility preservation supports.~      Principal objective is to ensure the absence of ovarian stimulation's side effects and~     assess chemotherapy effects on child carrying potential.~   "
110132|NCT01614691|"~     This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in~     patients with allergic rhinitis~   "
110133|NCT01614678|"~     The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses~     manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured~     using a semi-automatic process.~   "
110134|NCT01614665|"~     The purpose of this study is to compare how the body absorbs and processes two different~     formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children~     receiving an organ transplant, and how safe and effective they are over a longer period of~     time.~      This study is for children less than 16 years old. No minimum age has been set, however, to~     be included in this study participants must able to swallow the medication capsules intact.~   "
110135|NCT01614652|"~     Treatment of ischemic heart failure.~   "
110136|NCT01614639|"~     We are doing this research study to learn about how acupuncture treatment works. This study~     is being done to look at changes in the brain, NOT to treat pain. We want to learn about~     brain activity during acupuncture. We will look at brain activity when a heating device~     touches the skin of a subject before and after the subject has acupuncture, to see what~     changes.~   "
110137|NCT01614626|"~     The purpose of this study is to assess the longitudinal association between alcohol~     consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered~     coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to~     establish a sample repository.~   "
110138|NCT01614613|"~     The purpose of this study was to test the performance of an investigational Bayer Blood~     Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal~     was to obtain glucose samples from subjects with diabetes across the meter operating ranges.~     A capillary sample was collected from each subject at 3 different times during the visit to~     obtain natural capillary blood samples with a range of glucose concentrations. Some blood~     samples were glycolyzed to lower the glucose concentration levels and glucose solution was~     added to other samples to raise glucose concentration levels. All meter BG results were~     compared with plasma results obtained with a reference laboratory glucose method (YSI~     Glucose Analyzer). All lancings and testing were performed by study staff.~   "
110139|NCT01614600|"~     The purpose of this study was to evaluate the reduction of contact lens-related dryness~     symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES®~     AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens~     Dry Eye Questionnaire (CLDEQ).~   "
110140|NCT01614587|"~     The objective is to explore the genetic predisposition to early pelvic organ prolapse after~     adequate surgical repair by exploring the association between pelvic organ prolapse~     recurrences and certain polymorphisms.~   "
110141|NCT01614574|"~     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)~     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent~     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. The disease~     has been classified into 3 clinical subtypes based on the presence or absence of~     neurological symptoms and severity of neurological disease. Type 1 Gaucher disease affects~     an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does~     not involve the central nervous system. Patients with type 2 Gaucher disease present with~     acute neurological deterioration, which leads to early death. Those with type 3 disease~     typically display a more sub-acute neurological course, with later onset and slower~     progression.~      The primary objective of this study is to evaluate the safety of every other week dosing of~     velaglucerase alfa in Japanese patients with Gaucher disease.~      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type~     1 Gaucher disease.~   "
110142|NCT01614561|"~     This was a multicenter survey of patients who were on lipid -lowering pharmacological~     treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the~     effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan~     and Lebanon.~      Data collected from each patient took place at a single visit. Each participating doctor~     filled the investigator questionnaire on his/her experience and perception of the management~     of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her~     general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals~     and the various treatment options for high cholesterol in blood.~      Before being assessed by the investigator, patients recorded, on the patient questionnaire,~     their awareness of high blood cholesterol , their current lipid-lowering treatment schedule,~     their understanding of their condition and compliance in taking the medications on time.~      The investigators completed a Patient Record Form (PRF) with the patient's basic~     information, cardiovascular risk factors and the cardiovascular medical history, current~     lipid lowering drug treatment and the reason for the current therapy.~      A blood sample under fasting condition was drawn from each subject. A central laboratory in~     Jordan received all samples. Every sample was analyzed for its cholesterol blood level,~     fasting sugar level and hemoglobin A1C levels.~   "
110143|NCT01614548|"~     Some recent reports indicate that incidence of prostate cancer is increasing rapidly in~     China. However, no large-scale survey of prostate cancer has been done in central China, few~     data are available regarding its management. The investigators aimed to analyze the~     management of prostate cancer and compare the outcome of patients with such a survey.~      The investigators collected data of patients diagnosed with prostate cancer from the 2003~     and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival~     rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed~     using the log-rank test and Cox proportional hazards model.~   "
110144|NCT01614535|"~     The clinical studies demonstrate more powerful analgesic effect among female to both μ- and~     κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated~     predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators~     hypothesized that there are sex differences in the antitussive responses to opioid.~      It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough~     against endotracheal tube during emergence from general anesthesia. Some studies, reporting~     the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence~     in different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed~     differences in EC50 and EC95.~      The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI~     for preventing cough during emergence in each sex and to evaluate whether there were sex~     differences in EC50 and EC95 of remifentanil in effect-site TCI or not.~   "
110145|NCT01614522|"~     The purpose of this study is to determine whether ASLAN001 has an effect in patients with~     recurrent or metastatic adenocarcinoma of the stomach, gastrooesophageal junction, or lower~     third of the oesophagus whose tumours over-express HER-1 and HER-2, or whose tumours are~     HER-2 gene-amplified.~      Maximum of 26 patients will participate in South Korea and the patients will be assigned to~     either group A or group B according to the results of tests done on tumor tissue obtained by~     biopsy to determine HER-1 and HER-2 status.~   "
110146|NCT01614509|"~     This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined~     therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the~     treatment of macular edema associated with branch retinal vein occlusion.~   "
110147|NCT01614496|"~     The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop~     system, using subcutaneous way, for the overnight and prandial glucose control in type 1~     diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over~     study with a control night, using their usual insulin pump pattern, and with a experimental~     night, being controlled for the closed loop system. Each night includes the overnight~     control and prandial control of the breakfast.~      The system proposes an insulin dose every 5 minutes according with the value of glucose~     displayed by the continuous glucose monitoring system.~   "
110148|NCT01614483|"~     The overall aim of the project is to provide proof-of-principle that biofortification of~     cassava with vitamin A is a viable strategy to improve vitamin A status of deficient~     populations.~   "
110149|NCT01614470|"~     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator~     (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R,~     G970R, G1244E, S1251N, S1255P, or G1349D).~   "
110150|NCT01614457|"~     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects~     with cystic fibrosis (CF) who have the R117H-CFTR mutation.~   "
110151|NCT01614444|"~     The current study will assess the efficacy of acupressure, a type of complementary and~     alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild~     traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented~     and randomly assigned to either an active or placebo acupressure treatment series of 8~     sessions. The investigators will determine if acupressure affects aspects of day-to-day~     function, such as memory, sleep, mood, psychiatric health and stress resilience. This~     information will help identify potential treatment strategies to improve quality of life and~     overall function in this particular Veteran population.~   "
110152|NCT01614431|"~     This study intends to verify the interference of N acetyl cysteine in the progression of~     chronic kidney disease in patients with Nephropathic Cystinosis.~   "
110153|NCT01614418|"~     Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial~     neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic~     surveillance, there is no other intervention which predictably eradicates pre-cancerous~     gastric lesions.~      Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly~     effective in eradicating both IM and dysplasia in patients with Barrett's esophagus.~     However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In~     this study, we determine the feasibility of using endoscopic RFA in treating early gastric~     neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will~     be treated with endoscopic RFA. The safety and effects of RFA will be determined.~   "
110154|NCT01614405|"~     Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often~     require liver transplantation. The cause of disease is unknown. It is thought to occur as a~     result of an infection in subjects that are more susceptible to disease than others. The~     investigators found evidence of retrovirus infection in patients with primary biliary~     cirrhosis. The investigators found that most patients with PBC have evidence of viral~     infection. Since then the investigators have conducted clinical studies using anti-viral~     therapy. The investigators found that PBC patients treated with combination anti-retrovirus~     therapy experienced significant reversal of the disease process. However, the changes were~     not substantial and the investigators are now looking for better antiviral regimens. Now the~     investigators have found a mouse model with a similar virus infection that develops a~     similar biliary disease. Importantly, the investigators found that antiviral therapy blocks~     the development of the disease in this mouse. The investigators have used this model to find~     safer and more effective antiviral treatments for patients with PBC. The investigators have~     now found out that a combination of highly active antiretroviral therapy with Truvada and~     Kaletra stops disease in the mouse and plan to use this combination to see if it works in~     patients with PBC.~   "
110155|NCT01614392|"~     This research study is looking to compare the effects of two uniquely different power~     training interventions (high force, lower velocity versus low force, high velocity) on~     changes in mobility status among older individuals at risk for mobility disability.~   "
110156|NCT01614379|"~     Diabetic foot ulcers often progresses after many years of diabetes where the patients system~     is so damaged that normal heeling of ulcers cannot happen. The physician at the clinic~     examines the foot, measuring its circulation and sensitivity. The measures are the blood~     pressure in comparison between foot and upper arm and oxygen level in the foot. The~     measurements have a direct connection to the blood circulation, but it doesn't visualize the~     blood circulation.~      Development of MR methods without the use of contrast agents have become so good that images~     of the blood veins can be used in treatment. This means that the MR images provide important~     information about the patient vessel wall stiffness and blood circulation without the use of~     the damaging substances. Hence the physician can perform the MR examination and in~     comparison with the test performed at the clinic he can make an improved and without risk~     diagnose. Using MR at a lot earlier stage in the treatment is expected to reduce the number~     of amputations. This is not only an economic advantage, but also an improvement of the~     patient quality of life.~      The objective of the study is to investigate type 1 diabetics oxygen level, vessel wall~     stiffness, blood circulation, tissue contribution and blood pressure in the foot with the~     use of conventional measurements in their treatment and with the added use of MR methods.~      This will provide the physician with valuable information of the patient illness and is~     expected to play an important role in the prevention of diabetic foot ulcers. We expect that~     MR research leads to a much improved prevention and treatment of aggressive and destructive~     diabetic foot ulcers. This will increase the general quality of life and reduce the large~     number of amputations performed every year.~   "
110157|NCT01614366|"~     The purpose of this study is to compare the different dose of DMTA07 (DM) combine with~     amlodipine in the treatment of mild to moderate essential hypertension, and to define the~     optimized dose of DM in the combination therapy.~   "
110158|NCT01614353|"~     Patients can easily be overwhelmed, confused and many times don't fully understand their~     need for new medications, or when the dosages are to be administered (patient research~     partner quote). The long-term goal of this study is to refine medication science by~     developing patient-centered assessment, monitoring and management guidelines for patients~     and health professionals. The objective is to advance knowledge about the medication-taking~     perspectives, experiences, and behaviors of older adults with multiple chronic medical~     conditions (MCMC) to inform future research related to patient-centered medication~     prescribing, monitoring and management. This pilot study addresses the following PCORI~     interest area: evaluating methods that can be used to assess the patient perspective when~     researching behaviors and choices within the patient's control that may influence outcomes.~     The rationale that underlies the proposed study is that medication-taking practices are~     wholly within patients' control, and are foundational to reducing complications and~     improving outcomes for those with MCMC. To meet the overall objective of this application,~     the following specific aims will be pursued: 1) identify perceptions and behaviors~     surrounding the medication-taking process of older adults with MCMC; and 2) generate an~     interpretation of the meaning of medication-taking among older adults with MCMC. To achieve~     these aims, data will be obtained in real time from patients (N=30) receiving a new~     prescription using smart phone technology. The smart phones will include prompts to help~     participants record thoughts about medication use throughout the day for 30 days. Findings~     from electronic diaries will be logged, analyzed and qualitatively analyzed. Some patients~     (n=15) will provide in-depth hermeneutic interviews to provide rich descriptions and~     interpretive commentary about the experience of receiving a new medication prescription. The~     objective is to uncover previously unidentified areas of common experience in older persons~     with multiple chronic conditions who have received a new prescription. Common experiences~     and patterns of influences, that are often surprising or unexpected, will be categorized and~     assessed. The expected outcomes of this pilot study are improved knowledge of~     medication-taking perceptions, experiences, and practices of older adults with~     MCMC—knowledge that is critical to advance patient-centered medication science.~   "
110159|NCT01614340|"~     The overall goal of this real-world comparative effectiveness research (CER) study is to~     reduce disability among older home health patients by treating their pain more effectively.~     To achieve this goal the investigators will conduct a cluster randomized controlled trial of~     a physical therapist (PT) delivered intervention provided to VNSNY home health care patients~     with activity-limiting pain. The intervention is an evidence-based non-pharmacological~     program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain~     self-management (CBPSM) techniques.~   "
110168|NCT01614223|"~     Plantar fasciitis presents clinically as pain in the inner heal, which is the result of~     degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests~     predominantly in those subjected to sustained weight bearing or repetitive pounding~     activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most~     cases resolving within 6 months, traditional treatment regiments such as orthotics and~     physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic~     symptoms (Neufeld & Cerrato, 2008; Rompe, 2009; Roxas, 2005).~      Platelets are central players in clotting, inflammation and the wound healing response.~     Research has shown the potential of platelet rich plasma to accelerate wound healing in a~     variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing~     and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may~     accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample~     from the patient, isolating the platelets and injecting them back into that patient at the~     injury site~   "
110169|NCT01614210|"~     The purpose of the study is to see if tumors respond to endocrine therapy by taking a total~     of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the~     FDA (Food and Drug Administration) for use in the treatment of hormone positive breast~     cancer.~   "
110160|NCT01614327|"~     The study is an Observational, Phase 0 designed to establish that the risk for diabetic~     retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of~     any reader and it decreases the inter-reader variability.~      Objectives: Objectives one, two, and three are arranged chronologically and in an increasing~     level of complexity as a three tiered approach to support the primary and secondary endpoint~     of the trial. Objective one is to test fully each system components of the study limited to~     a single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the~     risk of Diabetic Retinopathy in comparison to the gold standard. Objective three is to~     demonstrate that the reader's accuracy in grading images is improved when risk levels~     assigned by the RiskAnalyzer are made available to the reader while performing the grading~     of the images which is the primary endpoint of the trial Methods and Research Design: A~     network of clinical study sites will be established to meet the required number of cases~     needed as calculated by statistical analysis. Male and Female Subjects between the ages of~     18-65 who are either pre-diabetic or diabetics will be eligible for participation in this~     study. Subjects will be recruited, consented, photographed and their images graded by two~     trained readers and analyzed by the RiskAnalyzer . The risk levels that are obtained from~     the RiskAnalyzer will be compared to the current gold standard practice, manual grading of~     each case by a reader. Data collected during this clinical trial will be reported to the~     referring physician in the form of a retinal screening report completed and signed by a~     licensed Ophthalmic professional and delivered to their attending physician. Risk levels for~     diabetic retinopathy obtained by use of the RiskAnalyzer will not be given to the attending~     physician under any circumstances in order to preserve standard of care for the patient.~      The sensitivity, specificity, receiver operating characteristic (ROC), and data flow process~     of the RiskAnalyzer, retinal image reading system will be analyzed and based on the current~     gold standard of a human reader. This study is a three-aims study, 24 month in length,~     prospective, case-only study of the performance of the RiskAnalyzer. The risk levels~     obtained from the RiskAnalyzer are not made visible, i.e. are not unmasked to either of the~     two readers. In year two, the risk levels obtained from the RiskAnalyzer for half of the~     studies are unmasked to the two readers while grading the image.~      Access to all study data and processes follows a role-based design. The clinical staff will~     have access only to clinical data but not the technical data. The technical team will have~     access to the technical data only but not the clinical data. The study coordinator will have~     access to all data. The use of computers will adhere to the Guidance for Industry~     Computerized Systems Used in Clinical Investigations and applicable sections of 21 CFRs part~     11.~   "
110161|NCT01614314|"~     The purpose of this study was to compare the performance of nursing undergraduates in~     dressing of tunneled central venous access in the simulator, according to the aid of a~     preceptorship or an auto-instructional guide.~   "
110162|NCT01614301|"~     A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of~     temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose~     trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma~      Phase I: To determine the dose of temsirolimus to be used in phase II part of the study~      Phase II:~      To determine overall survival Secondary objectives~        -  To evalulate response rate~        -  To evaluate time to progression (TTP)~        -  To evalulate time to partial response (time to PR or better)(TPR)~        -  To evaluate quality of life~        -  To evaluate tolerability and safety~   "
110163|NCT01614288|"~     Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a~     knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life~     questionnaires, and have a clinical evaluation done preoperative and at each follow-up~     visit.~   "
110164|NCT01614275|"~     The purpose of this study is to determine the extent to which technology may be used to~     provide (a) state-of-the-art assessment and intervention for children diagnosed with autism~     and (b) parent and tutor training for those who care for these children.~      Children with autism often have problems with social interaction, language, and repetitive~     behavior (e.g., hand flapping and body rocking). Without early and intensive treatments, the~     long-term outcomes for children with autism are not very good; therefore, it is very~     important that effective treatments are started as soon as possible. Research has shown that~     Early Intensive Behavioral Interventions (EIBI) is an effective treatment for autism.~     Although EIBI is effective, most children with autism in military families do not receive~     EIBI because there are few professionals and paraprofessionals that are appropriately~     trained to do this, especially in the remote areas where military families tend to serve.~     The investigators want to show that web-based technologies (e.g., web-cams and~     internet-protocol cameras) can be used so that professionals in one place can treat children~     with autism anywhere in the world. The investigators also expect that providing these~     services will help children with autism improve their language, social, and academic skills.~     The investigators expect that the gains made by the children will help relieve many daily~     stressors and worries that families with children with autism have.~      Children with autism who lack adaptive skills require constant help and supervision from~     parents. Thus, the improvements in the child's functioning will allow the child to become~     more independent and decrease parent stress associated with the need to constantly watch and~     help the child. Because EIBI services produce lasting improvements long after the~     intervention has ended, this project will provide both short-term and long-term benefits to~     the children who participate in the study, which will provide lasting relief to these~     dedicated military families.~      In the long-term, this project may really change the way in which all (military and~     non-military) children and families get effective services that they cannot get now. Also,~     the results may help other professionals and researchers in psychology and medicine. That~     is, the results should be helpful to any kind of service that uses parent training and~     paraprofessionals. Most importantly, these services will improve the overall functioning of~     the children with autism and decrease the overall stress on these families as they continue~     to serve our country.~   "
110165|NCT01614262|"~     Continuous glucose monitoring (CGM) technology has advanced the treatment of people with~     diabetes, however to date this technology had been primarily limited to use in patients~     treated with insulin. CGM is a powerful tool that has the potential to enhance the care of~     patients treated with agents other than insulin; however this has not been tested. The~     purpose of this study is to determine whether improved glycemic control can be achieved~     through the use of intensive, periodic CGM monitoring in patients with T2DM treated with~     oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be~     utilized to determine if a larger, clinical effectiveness study to assess use of CGM to~     improve clinical outcomes in patients with T2DM treated with OADs is warranted.~   "
110166|NCT01614249|"~     Fish oil omega-3 supplements provide essential nutrients for brain health and functioning.~     These nutrients have been proven to be effective in reducing depressive symptoms. They have~     also been found to be effective and well tolerated in reducing the bad fat accumulation~     among patients infected with human immunodeficiency virus (HIV)and are using highly active~     antiretroviral treatment. The role of this nutritional supplement in combating depression~     among pregnant women who are living with HIV infection has however not been established.~     Yet, currently, more than 2 million pregnant women are estimated to be living with HIV~     infection globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive.~      In this study, it is hypothesized that there is no difference in the levels of depressive~     symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and~     those taking a placebo.~      The study will therefore seek to ascertain that taking omega-3 fish oil nutritional~     supplement has a significant positive effect on depressive symptoms among HIV infected~     pregnant women, compared to a placebo.~   "
110167|NCT01614236|"~     Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most~     common questions asked by patients pertains to the amount of pain they will experience after~     surgery how long it will last and how good will it be controlled. Pain concerns the surgical~     team as well, because of its correlation with clinical outcomes and patients' satisfaction~     rate . Studies have shown that negative clinical outcome with regard to pain control~     includes decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia,~     hypertension, myocardial ischemia, transition into chronic pain, poor wound healing, and~     psychological sequelae .~   "
110170|NCT01614197|"~     This is a phase I study of temsirolimus (Torisel) combined with dexamethasone,~     cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL),~     lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).~   "
110173|NCT01614158|"~     This present research project intends to collect five quantitative test series:~        -  perimetric examination using static stimuli, assessing the entire (80 degree) visual~          field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/~          magnitude of the visual field defect and its variability within the cohort and over~          time~        -  D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]~        -  RAPD (using swinging flashlight test).~        -  IOP (using applanation tonometer)~        -  RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic~          disk morphology will be documented by fundus photography. This assessment of the~          above-mentioned data is needed in order to allow for estimation of the spontaneous~          course / fluctuation of the (quantified) functional and morphometric parameters of the~          N-AION patients during the follow-up period. This is essential for the estimation of~          the sample size of the subsequently intended SINN study, that is intended to compare~          different therapeutic strategies in N-AION patients.~   "
110174|NCT01614145|"~     Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in~     cerebrospinal fluid samples of immunocompromised patients for identification of central~     nervous system aspergillosis.~   "
110175|NCT01614132|"~     The purpose of this study is to determine whether a combination of a radiochemotherapy~     (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in~     adult patients with medulloblastoma is tolerable.~   "
110176|NCT01614119|"~     While the exercise responses are classically described at the cardiorespiratory and muscle~     levels, recent data suggest that the brain is also significantly stressed by exercise and~     may even participate to performance limitation. In hypoxia in particular, cerebral responses~     to exercise may be altered and promote performance reduction during endurance exercise. In~     the present study, the investigators used innovative approaches to assess cerebral~     perturbations associated with exercise in hypoxia.~   "
110177|NCT01614106|"~     This study will evaluate the efficacy of an integrated Retention Clinic in achieving~     virologic suppression among HIV-infected cocaine (including crack) users by using a~     two-group randomized, prospective trial. Eligible participants will be randomized to one of~     the following two groups: 1) Retention Clinic or 2) Treatment as Usual. The intervention~     (Retention Clinic) group will receive up to 11 Patient Navigator sessions over a 6 month~     period and 9 sessions of substance abuse treatment over a 3 month period. Follow-up~     assessments will be conducted at 6 and 12 months post-randomization. Medical records will be~     reviewed to document use of HIV care, drug treatment and mental health services during the~     study period. A total of 360 HIV-infected individuals who report cocaine (including crack)~     use will be randomized across both sites (Miami, FL, and Atlanta, GA). Primary hypothesis is~     that more participants randomized to the Retention Clinic will have undetectable viral~     load than will participants randomized to the treatment as usual group.~   "
110178|NCT01614093|"~     The objective of this study is to test a single dose of intranasal oxytocin, compared to~     placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety~     signaling (behaviorally and/or by self report) compared to placebo. If this single dose~     pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a~     prevention or treatment for weight gain and overeating in people with schizophrenia.~   "
110179|NCT01614080|"~     intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic~     stroke. This effect is due to an early recanalization secondary to the lysis of the clot.~     However this effect may be counterbalanced by the increased risk of bleeding and also the~     neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain~     (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to~     determine whether the functional outcome after treatment by iv rt-PA depends on the ratio~     sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain~     haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).~   "
110180|NCT01614067|"~     In couples with infertility secondary to Diminished Ovarian Reserve, the investigators~     hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist~     (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.~   "
110181|NCT01614054|"~     The purpose of this study is to show that a patient-centered survey asking about smoking~     habits, with the option for nicotine replacement therapy (NRT) will increase the~     prescription rates among health care providers (HCP). The investigators also believe that~     this intervention can also lead to increased referrals to smoking cessation clinics and~     ultimately increase rates of smoking cessation.~   "
110182|NCT01614041|"~     The purpose of this study is to evaluate the efficacy and safety of comparative high dose~     Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.~   "
110183|NCT01614028|"~     This study aims to investigate short-term outcomes following the use of two femoral stems~     used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.~   "
110184|NCT01614015|"~     The proposed effectiveness study examines differences in treatment outcomes of an~     observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be~     implemented within 16 teams delivering FFT services at 11 sites in the California Institute~     of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either~     to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of~     18 families per team. Thus, each condition will include 24 therapists who will treat 144~     families. The project will be implemented in four staggered waves to establish a more even~     rate of data collection and treatment implementation to enhance the feasibility of the study~     by keeping staffing and project costs more constant across the 5-year project. Each wave~     will involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to~     supervision conditions. Outcome assessments of parents and adolescents will be conducted at~     baseline and at 4 months and 16 months after treatment initiation.~   "
110185|NCT01614002|"~     The main purpose of this observational study with Docetaxel is to determine the number of~     treatment cycles and the quantity of Doce onkovis needed therefore under the special~     circumstance of ambulant chemotherapy.~      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted~     packaging sizes as to decrease the excess quantity to be discarded follows also this~     objective.~      Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To~     this purpose data regarding co medications and adverse events are also collected.~   "
110187|NCT01613976|"~     The purpose of this study is to confirm the safety and tolerability of oral panobinostat~     (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients~     with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute~     Myeloid Leukemia (AML).~   "
110188|NCT01613963|"~     This is a study of visual outcomes in retinal disease that seeks to identify the causes of~     visual loss. This data will be used to predict which patients are at risk of losing vision~     and how they can be better treated.~   "
110189|NCT01613950|"~     The study is intended to investigate the safety of BYL719 and AUY922 in patients with~     advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination.~     In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the~     pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study,~     if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.~      The study includes a dose escalation part followed by a safety expansion phase.~   "
110190|NCT01613937|"~     Objective: The current study examined the effectiveness of a culturally-appropriate~     adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes~     risk in Latinas with a history of gestational diabetes mellitus (GDM).~      Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3~     years participated in an 8-week group-based, peer-educator led lifestyle intervention based~     on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and~     self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up~     (month-6).~      Hypothesis-The modified culturally tailored DPP will improve risk factors associated with~     the development of type 2 DM.~   "
110191|NCT01613924|"~     The aim of our study is to determine the time to resolution of individual acne lesions using~     a popular handheld heat based device in comparison to no treatment and to standard topical~     therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment~     of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.~   "
110192|NCT01613911|"~     This study will help describe how the human brain works when a person sees something, hears~     something, learns something, or thinks about something by recording brain activity that~     occurs when the person does a series of computer tasks. This study will be offered to people~     who are in the hospital to be monitored for epilepsy by using electrodes placed in the~     brain. The study will record brain activity that occurs when a patient does a memory task,~     for example.~   "
110193|NCT01613898|"~     The aim of the proposed study is to evaluate the risk for cardiovascular disease and~     'atherogenic' features of the serum in CTX and to determine preclinical atherosclerosis. The~     study will include an extensive assessment of lipoprotein profile and carotid artery~     intima-media thickness (cIMT) measurement.~      Lipid and lipoprotein profiles will include novel tests such as direct measurements of~     apolipoprotein A1,B,C2,C3 plasma levels, lipoprotein (a) levels, highly sensitive C-reactive~     protein levels and PLAC test that measures the levels of lipoprotein-associated~     phospholipase A2-a vascular-specific inflammatory enzyme implicated in the formation of~     atherosclerosis~   "
110194|NCT01613885|"~     The purpose of this study is to gain better understanding of how the immune system works in~     twins with and without allergic disease. Healthy volunteers are not specifically targeted.~     Healthy non-allergic study participants may be found through the course of evaluation for~     the presence of allergies.~   "
110195|NCT01613872|"~     This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard~     protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury~     (TBI). The investigators are testing whether this intervention can help improve the stress~     response and increase resiliency and mindfulness for patients with TBI, which may lead to~     improved symptoms and neurocognitive function.~   "
110196|NCT01613859|"~     Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is~     an integral part of hemodynamic monitoring of critically ill patients whether it is done~     directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies~     to support the cardiovascular system in critically ill children with multi organ~     dysfunction. Because of the side effects involved in measuring cardiac output directly,~     intensive monitoring of patients is currently limited to an integrated assessment of tissue~     perfusion, oxygen delivery and cellular health both at regional and global levels. Currently~     available methods of measuring CO have their limitations and complications, and are not used~     routinely for bedside monitoring. Therefore, the investigators propose to use a newly~     developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.~   "
110197|NCT01613846|"~     Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell~     Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative~     data in advanced RCC (or other indications) have been published. A search in the~     clinicaltrials.gov database did not reveal any planned or ongoing studies. As sequential~     therapy is now the standard of treatment for advanced RCC it is important to evaluate in~     clinical trials what the value of different sequential strategies is. This needs to be done~     every time new agents are introduced into the treatment armamentarium. As there are no data~     yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence,~     however, will most certainly be used in daily practice, it is required to examine efficacy~     and safety of this sequential approach in a clinical trial in a randomized setting.~      Therefore, the investigators have designed an open randomized study in patients not~     previously treated for advanced RCC. Suitable patients will be randomized (1:1) in 2 groups.~   "
110211|NCT01613651|"~     This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP)~     with pelvic drain placement to see how well it works compared to RALP without pelvic drain~     replacement in reducing adverse events after surgery in patients with prostate cancer.~   "
110243|NCT01613235|"~     The objective of this multi-centre, randomized controlled trial is to investigate the~     outcome after induced hypertension versus no induced hypertension in patients with delayed~     cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess~     whether induced hypertension results in improved cerebral blood flow (CBF) as measured by~     means of perfusion-CT.~   "
110244|NCT01613222|"~     A 2 phase study to test the accuracy of SpO2 sensors with various patient monitors,~     co-oximeters, and modules.~   "
110198|NCT01613833|"~     Osteoarthritis (OA) is the irreversible degeneration of articular cartilage and underlying~     bone. It poses a major healthcare problem as it is the leading cause of joint disease and~     disability in the United States. It was traditionally thought that OA was a consequence of~     aging and joint trauma. However, it is now thought that OA is a result of the interplay of~     multiple genetic, biomechanical, and biochemical factors that disrupt the normal homeostasis~     of cartilage, bone, and synovium.~      OA is classified into two groups, primary and secondary. Primary OA is classically~     polyarticular and peripheral while secondary OA can commonly be attributed to a specific~     cause, limited to a singular joint, and a result of trauma. It is known as post-traumatic OA~     (PTOA). Other causes of secondary OA include congenital disorders, calcium pyrophosphate~     dehydrate deposition disease, and other diseases. Regardless of classification, genetic~     variation in the normal metabolism of cartilage and bone is thought to play a role in the~     progression of OA. Furthermore, the polyarticular presentation of primary idiopathic~     osteoarthritis suggests that it may have a stronger genetic component as compared to~     secondary OA, indicating a deviation from normal cartilage and bone homeostasis.~      Matrix metalloproteinases (MMP) and their inhibitors take part in the metabolism of~     cartilage and bone. MMPs are enzymes that catalyze the degradation of elements within joint~     spaces while their inhibitors cease this activity. Alpha-2-Macroglobulin (A2M) is a~     naturally-occurring plasma glycoprotein that functions throughout multiple tissues and~     extracellular spaces as a protease inhibitor but does not normally reach high levels within~     the intra-articular joint space. A2M is believed to modulate the systemic inflammatory~     response by its ability to bait, trap, and clear various MMPs and cytokines. Concentrated~     A2M directly addresses the roles of cytokines and catabolic enzymes known to participate in~     the development of osteoarthritis. Cytonics has shown that A2M can inhibit cartilage~     degradation in vitro. As the role of MMPs and protease inhibitors have emerged as key~     components of OA, the investigation of regulators of MMP has become of interest to elucidate~     the pathogenesis and possible novel treatments of OA.~      This study aims to measure and correlate the levels of alpha-2-Macroglobulin (A2M) in plasma~     and knee joint OA between primary post-traumatic (PTOA) and secondary osteoarthritis groups.~   "
110199|NCT01613820|"~     Ketamine infusions resulted in an acute reduction in global depression scores and in~     severity of suicidal ideation. Scopolamine infusions produced also a significant improvement~     in depression that was sustained over time.~      We therefore plan to investigate the feasibility and efficacy of open-label repeated~     intravenous administration of ketamine and scopolamine combined in this population of~     severely depressed, treatment-resistant patients. The results from this study could lead to~     the development of new strategies for the treatment of patients with TRD.~   "
110200|NCT01613807|"~     Humalog® Mix50/50TM administered as 3 injections daily is equivalent to Humalog® plus~     Humulin N® insulin administered as 6 separate injections daily in terms of glucose control,~     but may have some advantages due to increased ease of use.~   "
110201|NCT01613794|"~     Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial~     cardiovascular disease after venous thrombosis, most predominant in the first year following~     initial venous thrombosis. The results of recent observational studies that showed 40-50%~     risk reductions for first venous thrombosis occurrence when using a statin are in this~     aspect promising. The results are also somewhat surprising, because the mechanism behind~     this effect is unclear. Dyslipidemia may be the most plausible explanation to be considered.~     However, as dyslipidemia is not related to an increased risk of venous thrombosis, it is~     unlikely that statins decrease venous thrombosis risk by lipid lowering activities. Recent~     observations indicate that coagulation can activate the initial formation of~     atherosclerosis. Our hypothesis is therefore that the coagulation profile in persons with~     venous thrombosis is improved when using a statin, ultimately leading to less~     atherosclerosis: another well known property of statin use.~   "
110202|NCT01613781|"~     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical~     outcome of MVD. However, there have been no evidence of which degree of partial~     neuromuscular blockade should be performed during LSR monitoring under sevoflurane~     anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate~     the effect of different degree of partial neuromuscular blockade on the LSR monitoring for~     MVD surgery.~   "
110203|NCT01613768|"~     Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in~     patients with salivary gland cancer. Researchers want to know if eribulin is safe and~     effective in treating salivary gland cancer.~   "
110204|NCT01613755|"~     The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole~     are often used concomitantly in patients with diabetes who have suffered a transient~     ischemic attack or stroke. It has recently been suggested that the gastrointestinal~     absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4).~     Dipyridamole has been reported to inhibit hENT4 transport in vitro. The aim of this research~     proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. The~     investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of~     metformin. If this hypothesis can be confirmed, then the results of this study can explain~     in part the high variability in plasma metformin concentrations in patients treated with~     diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.~   "
110205|NCT01613729|"~     The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once~     daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with~     hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.~   "
110206|NCT01613716|"~     This study will examine the use of the dexamethasone implant (Ozurdex) in patients with~     macular edema associated with an epiretinal or preretinal membrane requiring surgical~     intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant~     will be placed in the eye. Patients will be followed for 1 year.~   "
110207|NCT01613703|"~     The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in~     healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for~     TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the~     plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952~     in healthy subjects.~   "
110208|NCT01613690|"~     The purpose of this study is to see how the body processes and gets rid of NVA237 in people~     who have impaired kidney function compared to people whose kidney function is normal.~   "
110209|NCT01613677|"~     This is a single arm open label phase II trial to evaluate the oral daily use of BKM 120 in~     patients with recurrent unresectable or metastatic cervical cancer after palliative~     cisplatin based regimen failure.~      A complete treatment cycle is defined as a 28 days period.~   "
110210|NCT01613664|"~     Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice~     in the surgical management of patients with morbid obesity. However, this restrictive~     procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage~     (1%) and intra-abdominal loco regional collections (1%). At present, there is no~     sufficiently reliable technique to prevent these complications.~   "
110212|NCT01613638|"~     Congenital malformations rate is about 3% in France. There are already 5 registries in~     France, covering about 16% of French births: Paris Registry, (about 38 000 births /year),~     Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000~     births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The~     aim of malformation registries is to carry out epidemiologic surveillance of congenital~     anomalies. The objectives are mainly to provide essential epidemiologic information on~     congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an~     information and resource centre regarding clusters, to provide data for research related to~     the causes and prevention of congenital anomalies.~      A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille~     et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to~     record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida,~     diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those~     observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence~     regarding congenital heart diseases and hypospadia. In this study the investigators could~     not determine whether this was due to a real higher frequency or to a particular~     exhaustiveness in the recording methodology.~      There are hypothesis about the role of intrauterine exposure to pesticides, known as~     endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive~     agricultural area, and it is thus worth studying the impact of pesticides exposure on~     congenital anomalies.~      There are also hypothesis on the impact of occupational exposure to solvents on congenital~     anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8%~     pregnant women in France) on oro-facial clefts and congenital heart diseases.~      The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to~     study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk~     of congenital malformations diagnosed at births, by measuring the exposure both directly in~     meconium, and indirectly by questionnaires.~      Secondary objectives are to study other risk factors such as medicine intake, pregnancy~     illness…~   "
110213|NCT01613625|"~     Elastography is a emerging imaging technique that has demonstrated high reliability in the~     assessment of tissues stiffness and quantification of fibrosis particularly in adult's~     livers. This ultrasound exploration has no secondary effects. There is no study published in~     the pediatric population concerning the role of ultrasound elastrography in kidney. The aim~     of this study is to look for a correlation between the elastography's results and the kidney~     fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential~     diagnostic and/or prognostic role in the management of these patients which would limit~     invasive biopsy procedures.~   "
110214|NCT01613612|"~     The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell~     implantation combined with core decompression to single core decompression for the treatment~     of avascular necrosis of femoral head.~   "
110215|NCT01613599|"~     This prospective observational study will evaluate the long-term safety of MabThera/Rituxan~     (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic~     polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on~     MabThera/Rituxan therapy by their physician according to prescribing information.~   "
110216|NCT01613586|"~     In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared~     with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial~     Cystitis.~   "
110217|NCT01613573|"~     The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG~     somatropin, which administered once per week, compared with the daily used somatropin, and~     to evaluate the safety and possibility to replace daily used somatropin.~   "
110218|NCT01613560|"~     This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study.~     The objective of this study is to prospectively verify the relation of efficacy of~     neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary~     adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant~     endocrinotherapy.~   "
110219|NCT01613547|"~     This study will be conducted as a randomized, double-blind, placebo-controlled trial to~     compare routine antibiotic prescription vs. no routine antibiotic prescription in the~     management of uncomplicated cases of severe acute malnutrition treated in the community in~     terms of nutritional recovery. The investigators hypothesize that there will be no~     significant difference in terms of the risk of nutritional recovery among children~     uncomplicated cases of severe acute malnutrition treated in the community that receive~     routine antibiotic prescription and those who receive no routine antibiotic prescription.~   "
110220|NCT01613534|"~     The aim of this study was to compare the efficacy and safety of two treatment regimens:~     argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for~     chronic hemorrhagic radiation proctopathy.~   "
110221|NCT01613521|"~     This study is to assess how patients respond to their treatment for cervical cancer. This~     research does not involve a specific treatment for the cancer that will be recommended by~     the doctor and may include radiation therapy and/or chemotherapy. This is a separate~     research imaging study designed to assess how patients respond to their treatment for~     cervical cancer.~   "
110222|NCT01613508|"~     The primary aim of the study is to compare the results of an established, successful~     procedure, which is total hip arthroplasty through a mini-posterior approach to a less~     studied - increasingly popular procedure, which is total hip replacement through the direct~     anterior approach utilizing the orthopedic table.~   "
110223|NCT01613495|"~     The purpose of this study is to learn more about how octreotide (Sandostatin LAR® Depot)~     affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.~   "
110224|NCT01613482|"~     Evaluate the survival without metastasis in patients treated by Trastuzumab in association~     with other chemotherapies for a breast cancer expressing HER2-NEU.~   "
110225|NCT01613469|"~     This study will assess the complete clinical response (no clinical evidence of remaining~     disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal~     opening after radiation therapy given at the same time as chemotherapy over a 6 week period,~     followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up~     begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up~     every 4-6 weeks for one year.~   "
110226|NCT01613456|"~     The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae~     CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the~     irritable bowel syndrome (IBS)~   "
110227|NCT01613443|"~     Concentration determinations of anticoagulants require plasma instead of whole blood, and~     results are not immediately available to clinicians. Monitoring anticoagulants concentration~     along with bedside methods may provide an alternative guide for administration of the NOAC.~      The purpose of this investigation is to compare bedside coagulation assays in whole blood~     with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with~     therapeutic dosis of NOAC.~   "
110242|NCT01613248|"~     The purpose of this study is to assess the effectiveness, safety and tolerability of a range~     of doses of MK-1602 versus placebo in the treatment of acute migraine.~   "
110228|NCT01613430|"~     The overall goal of the COACH study is to conduct a comparative effectiveness trial to~     assess the effectiveness of trained, participant-designated health coaches versus~     traditional health education efforts on cancer screening among African American older~     adults. We hypothesize that members of older adults' extended families can be trained to be~     effective coaches who support them through the cancer control spectrum, i.e., prevention,~     screening, diagnosis and treatment. This research objective is guided by the theoretical~     model of the PRECEDE-PROCEED conceptual framework that has been widely adopted in health~     promotion. The target jurisdictions for this study are Baltimore City (BC) and Prince~     George's County (PGC), Maryland. The study is anchored in community-based participatory~     research (CBPR) principles, involving community members in all its phases. The CBPR~     component is guided by Community Advisory Groups (CAGs) representing key stakeholders in the~     two jurisdictions. The CAGs are essential in determining the questions included in data~     collection instruments, mechanisms of recruitment, interpretation of findings, and~     dissemination of results within the target communities.~   "
110229|NCT01613417|"~     This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated~     comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in~     subjects with brain tumors to confirm the identical overall technical and diagnostic~     performance of the two MR contrast agents.~   "
110230|NCT01613404|"~     The purpose of the study is to compare the 90 day and 12 month composite end point of death~     (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to~     receive support from a dedicated case manager (intervention group) versus those not~     receiving support from a dedicated case manager (control group).~   "
110231|NCT01613391|"~     This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent~     to RYGBP, LAGB and their relation with obesity.~   "
110232|NCT01613378|"~     This multi-center, non-interventional study will evaluate the pattern of usage in clinical~     practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients~     initiated on treatment with tocilizumab according to the licensed Canadian product monograph~     recommendations will be followed for 12 months from the start of treatment.~   "
110233|NCT01613365|"~     Despite improvement of per and postoperative management, major pulmonary surgery continues~     to carry out a high morbidity with a significant mortality. Among postoperative~     complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most~     frequent and serious, as well as being the primary cause of hospital death, after major~     pulmonary resections. Vast majority of these complications are notoriously infectious and~     should be considered as hospital-acquired infections. These complications result in a~     dramatic increased of substantial hospital costs in term of length of hospital stay,~     antibiotics and morbidity. Current management of these complications stands on antibiotics,~     oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non~     invasive) is justify in near 25 % of cases.~      Recent data have suggested that proximal airways colonizations could be an essential first~     step in the pathogenesis of theses respiratory failures. Previous works have long~     demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer~     patients. These colonizations could act as a major predisposing factor to these~     postoperative respiratory failures. Because distal airways and lung parenchyma are free from~     bacteria at the moment of the surgery, respiratory complications should be the result from~     contamination by potential microorganisms belonging the upper aero-digestive tract.~     Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and~     during the first days after surgery could have a beneficial advantage in the prevention of~     these complications. This decontamination has been demonstrated to be effective in~     critically-ill patients in intensive care unit, in cardiac surgery and in esophageal~     surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has~     significantly reduced the rate of postoperative global hospital-acquired infections and~     respiratory infectious as well. To date, data on the efficacy of this decontamination~     protocol in major pulmonary resections are not available.~   "
110234|NCT01613352|"~     The aim was to assess the patient compliance and medical and psychosocial effects of same~     day hospital discharge after breast conserving surgery and sentinel node biopsy only.~   "
110235|NCT01613339|"~     Affected balance capacity is common after a stroke due to paresis and sensory disturbances.~     The affected balance capacity may cause walking disturbances, falls and decreased mobility.~     Balance may be improved by physical therapy. A possible method for balance training is body~     awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal.~     Earlier body awareness therapy was mostly used in psychiatric care but in the recent years~     the method has been used for people with long-tern pain, amputations and multiple sclerosis.~     Body awareness therapy includes exercises in lying, sitting and standing. Focus of the~     exercises are awareness of one´s movement behaviour, breathing patterns, resources and~     limitations. Postural control is an essential part in the exercises. Body awareness therapy~     could be used for people with stroke as a way to improve postural control. The aim of this~     study is to investigate if balance training using body awareness therapy can improve balance~     and walking in people after stroke. The interventions consists of body awareness therapy~     once a week for 8 weeks.~   "
110236|NCT01613326|"~     This study compared the efficacy and safety of NVA237 with tiotropium in patients with~     moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.~   "
110237|NCT01613313|"~     The purpose of this research is to evaluate the safest and most effective dose of a Food and~     Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors~     of varying sizes that occur commonly in the adult population). The fat in the lipoma is like~     normal fat except that it is enclosed in a balloon-like structure which is made of collagen~     (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that~     breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing~     the size of the lipoma or removing it.~   "
110238|NCT01613300|"~     The aim of this study is rate of acute graft-versus-host disease II-IV measured at day~     +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk~     non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant~   "
110239|NCT01613287|"~     This clinical investigation is a medical device trial to examine the safety and efficacy of~     TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used~     exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy~     (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary~     Arterial Hypertension and WHO functional classification III.~   "
110240|NCT01613274|"~     The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon~     resection surgery decrease the time to first flatus, bowel movement and length of stay in~     the hospital.~   "
110241|NCT01613261|"~     This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib~     in Adult Patients With Advanced Nonhematologic Malignancies~   "
110245|NCT01613209|"~     The investigators want to find out whether a recently introduced combination of two blood~     pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering~     effect than a single active substance. In addition the investigators want to find out~     whether there is a difference in the changes in blood pressure over the course of a day~     depending on the time when the medications are taken (in the morning or at night). Male and~     female patients over 18 years of age may participate.~   "
110246|NCT01613196|"~     Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence~     of bacteriological cure is difficult to be obtained raising the need for other therapeutic~     assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in~     Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory~     cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in~     the foci of TB during treatment permitting a non-invasive monitoring of therapeutic~     response. The main objective is to describe the evolution under treatment of the FDG uptake~     in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary~     objectives are to compare the decrease of FDG uptake according to type of location, to~     define the frequency of localizations revealed by FDG-PET and their impact on therapeutic~     management at the beginning and the end of treatment, and to describe the evolution of PET~     in patients not cured.~   "
110247|NCT01613183|"~     The objective of this study is to screen the effective core formulation in insomnia~     treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.~   "
110248|NCT01613170|"~     The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the~     use of Toviaz alone for the treatment of overactive bladder.~   "
110249|NCT01613157|"~     The investigators would like to carry out this study to measure drug levels in HIV-infected~     women that are taking anti-HIV medications. This study will determine the predictors of high~     drug levels and will assess the association of drug levels and adverse events in women.~   "
110250|NCT01613144|"~     This is an Open-label, prospective, randomized, multi-center post-market study.~   "
110251|NCT01613131|"~     Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills~     (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs~     have become a popular option, and one that is FDA approved for use until menopause. However,~     use of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous~     thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction~     (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where~     the background population risk of MI begins to increase, such that the absolute number of~     cases rises substantially. Women with additional risk factors for cardiovascular disease~     have a much greater risk for MI (6-40-fold) in association with OCPs. There are also large~     subgroups of midlife women who are not candidates for OCP use, such a smokers and~     migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20~     micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk.~      Because of their increased potential risks, it is appropriate to seek alternatives to OCPs~     and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior~     to a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of~     reproductively aging women is more susceptible to suppression by sex steroids that~     previously believed. It is possible that hormone doses as low as 50 micrograms of~     transdermal estradiol (TDE) can suppress the hypothalamic-pituitary axis of midlife women.~     It is also tempting to speculate that the low but measurable circulating doses of~     levonorgestrel that are present when a woman uses the Mirena intrauterine system (IUS) can~     contribute to or even independently suppress the hypothalamic-pituitary axis, and reduce the~     hormonal fluctuations that result in worsening of perimenopausal symptoms. The combination~     of low dose TDE plus Mirena may therefore confer superior symptom control as well as~     contraceptive effectiveness, at far less risk.~   "
110252|NCT01613118|"~     This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor~     antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is~     safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).~   "
110253|NCT01613105|"~     In this prospective, non interventional, observational Post Marketing Survelliance study~     data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of~     sulfonylurea under daily life treatment conditions.Specifically investigated is the~     influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's~     weight when added to an already existing sulfonylurea therapy.The study is planned to~     carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing~     Survelliance study will be performed with commercially available medication prescribed~     within regular practice of the physician. No other examination will be performed than would~     be done without Post Marketing Survelliance study.~   "
110254|NCT01613092|"~     The goal of the pilot study is to compare whether a centre-wide policy of incremental~     antibiotic therapy will reduce pacemaker infection compared to a policy of conventional~     antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This~     pilot study will provide feasibility information for a larger cluster randomized crossover~     design (CRCD).~   "
110255|NCT01613079|"~     Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the~     treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized,~     prospective multi-center clinical trial. Observation period of 24 weeks.~   "
110256|NCT01613066|"~     Cord blood (CB) from an unrelated donor is increasingly used an alternative source of~     hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched~     donor. However, the utilization of single-unit CB for transplantation of adult patients has~     been impeded by the low number of nucleated cells available from individual CB units. Direct~     intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose~     problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a~     phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult~     patients with advanced or high-risk hematological malignancies~   "
110257|NCT01613053|"~     Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.~   "
110258|NCT01613040|"~     This multiple-center, multiple-dose, randomized, double-blind, double-dummy,~     placebo-controlled, positive-controlled, parallel group study will investigate the effect of~     RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized~     to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm~     C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and~     moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.~   "
110273|NCT01612845|"~     The objective of this study was to prospectively evaluate the influence of local application~     of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the~     arthroscopically repaired tendons in patients with massive tears of the rotator cuff.~   "
110259|NCT01613027|"~     This observational study will evaluate the effect on disease activity and the safety in~     routine clinical practice of MabThera (rituximab) in participants with active seropositive~     rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor~     inhibitor (anti-TNF) therapies.~   "
110260|NCT01613014|"~     The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly~     percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to~     placebo. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more~     drinks per drinking day for men.~   "
110261|NCT01613001|"~     To study the first hypothesis, a retrospective cohort analysis of Air Force members from~     January 2005 to December 2010 will be performed to evaluate the association of obesity as an~     independent predictor variable with musculoskeletal disease as the dependent variable.~   "
110262|NCT01612988|"~     ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and~     MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).~      A study of the GOELAMS / GCFLLC-MW intergroup~   "
110263|NCT01612975|"~     Following a lung resection procedure, patients have their pleural space drained of fluid~     that accumulates due to the severing of proximal vessels like lymph nodes. The volume of~     fluid pumped depends on the severity of the inflammation. The investigators are conduction~     this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and~     reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are~     discharged faster, with a greater comfort level, and a hopefully lower rate of admission.~   "
110264|NCT01612962|"~     In this study, the investigators will perform a retrospective chart analysis of patients~     that underwent a bony debridement or amputation in the operating room at Georgetown~     University Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews,~     medical records and operative reports via EMR and paper charts will be examined from~     inpatient records, the Center for Wound Healing, the Emergency Department as well as other~     institutions involved in the care of the subjects to gather data.~   "
110265|NCT01612949|"~     The aim of this project is to develop a computer algorithm that can accurately predict how~     easy or difficult it is to intubate a patient based upon digital photographs from three~     different perspectives. Such an application can provide a consistent, quantitative measure~     of intubation difficulty by analyzing facial features in captured photographs - features~     which have previously been shown to correlate with how easy or how hard it would be to~     perform the intubation procedure. This is in contrast to established subjective protocols~     that also serve to predict intubation difficulty, albeit with lower accuracy. A digital~     application has the potential to decrease potential complications related to intubation~     difficulty and increase patient safety.~   "
110266|NCT01612936|"~     The specific hypothesis for this study is that there are fundamental differences in T~     effector and T regulatory cell responses in the lung to allergens in allergic asthma (AA)~     when compared to allergic nonasthmatics (ANA) that account for the difference in clinical~     responses. We will address this by comparing T cell responses in AA versus ANA subjects.~     These experiments will correlate T cell responses with measures of airway physiology using~     state-of-the art lung imaging and examine mechanisms controlling T cell activation in the~     airways of AA and the function of airway T regulatory cells during AA.~   "
110267|NCT01612923|"~     The physical examination before an abortion is usually performed by a physician. However, in~     many countries access to physicians is limited. To increase access to safe abortion this~     study wishes to examine if midlevel providers such as specially trained midwives can provide~     safe abortion services. Midwives in study were specially trained to perform early pregnancy~     ultrasound and if needed to consult a physician. The midwife then provided the abortion~     service as well as the contraceptive advice. Women were randomized to receive the service~     from a midwife or a physician.~   "
110268|NCT01612910|"~     This study is being done to find out whether a nutritional supplement, called~     BioResponse-DIM (BR-DIM [oral microencapsulated diindolylmethane]), improves the survival~     for women who have residual cancer cells following surgery after chemotherapy for breast~     cancer. BR-DIM is an active ingredient in cruciferous vegetables (broccoli, brussels sprouts~     and cauliflower). Consumption of these vegetables has been associated with a decreased risk~     in several cancers. Researchers also hope to find out whether different biomarkers (also~     called markers) in the blood predict the chance of breast cancer returning. BR-DIM is~     thought to be effective in treating stage II-III breast cancer that is triple negative, AR~     positive (+), and where there is residual cancer cells in the breast after chemotherapy.~   "
110269|NCT01612897|"~     The investigators hypothesize that children seen in a clinic that uses a compute based~     system known as CHICA, which reminds pediatricians to screen at defined time point for~     autism, will be screened more consistently for autism and receive more timely diagnostic a~     treatment services.~   "
110270|NCT01612884|"~     Personalized treatment approaches and antiplatelet drug choice have been proposed to~     optimize safety of coronary stenting by reducing heart attacks and repeat interventions~     while simultaneously minimizing adverse bleeding events. This study compares the efficacy of~     two laboratory guided treatment algorithms to personalize antiplatelet medication choice~     after coronary stenting~   "
110271|NCT01612871|"~     This is a biomedical and prospective study of interventional type. The trial will include 29~     patients over a period of 15 months + 24 months of follow up maximum.~      The study will be conduct in womens with metastatic invasive breast cancer or locally~     advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line~     hormone therapy for metastatic breast cancer) is indicated.~      The main objective of this pilot study is to evaluate the feasibility to detect in the~     circulating blood of patients, before treatment (T0), the presence of the fifteen tissular~     microRNAs described in preclinical studies as possibly involved in hormone~     resistance/sensitivity.~      In parallel of the detection of these specific miRNAs, we will conduct a larger scale~     analysis of circulating miRNAs in these patients before (T = 0) and after one month of~     treatment (T28).~   "
110272|NCT01612858|"~     The purpose of this study is to examine the relationship between insulin resistance and~     changes in body fat distribution in HIV-infected persons. This study measures insulin~     sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the~     effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body~     fat in this population.~   "
110274|NCT01612832|"~     Background:~      Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most~     common questions asked by patients pertains to the amount of pain they will experience after~     surgery how long it will last and how good will it be controlled. Pain concerns the surgical~     team as well, because of its correlation with clinical outcomes and patients' satisfaction~     rate. Studies have shown that negative clinical outcome with regard to pain control includes~     decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,~     myocardial ischemia, transition into chronic pain, poor wound healing, and psychological~     sequelae .~      Pain has been found to be one of the three most common medical causes of delayed/aborted~     discharge after ambulatory surgery, the other two being drowsiness and postoperative~     nausea/vomiting. Despite progress that has been made with regard to postoperative pain~     control, and the development of new standards for pain control, many patients continue to~     experience intense pain after surgery .~      Recent advances in the understanding of the particularities of central sensitization~     indicate that it plays an important role in post surgical and post traumatic pain and~     therefore should be avoided~   "
110275|NCT01612819|"~     Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients~   "
110276|NCT01612806|"~     To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the~     treatment of venous leg ulcers (VLUs).~   "
110277|NCT01612793|"~     This study will look at the safety, improving symptoms and decreasing the length of stay of~     patients admitted to the hospital with COPD.~   "
110278|NCT01612780|"~     The purpose of this study is to show clinically meaningful improvement in symptom severity~     after trans-nasal balloon dilation of the maxillary sinus outflow tract with or without~     balloon dilation of the frontal or sphenoid sinuses.~   "
110279|NCT01612767|"~     The purpose of this study is to demonstrate the safety and efficacy of the investigational~     BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native~     coronary arteries.~   "
110280|NCT01612754|"~     Aim of Study: Adverse effects from noise pollution in operation theatres have been throughly~     demonstrated. We assessed the impact of a noise reduction program in paediatric surgery.~      Methods: A prospective controlled study on 156 operations performed by 16 surgeons was~     conducted. The sound levels before and after a noise reduction program based on education,~     rules and technical devices (Sound Ear tm) were assessed. Endpoints were spatially resolved~     sound levels matched by the surgeon's biometric (saliva cortisol, electrodermal activity)~     and behavioural stress responses (questionnaires). These were correlated with mission~     protocols and NoiSeQ for individual noise sensitivity.~   "
110281|NCT01612741|"~     In this prospective, non interventional, observational Post Marketing Survelliance study~     data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of~     metformin under daily life treatment conditions.Specifically investigated is the influence~     of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when~     added to an already existing metformin therapy.The study is planned to carried out in 25000~     - 30000 patients from 200 trial sites in India.The PMS study will be performed with~     commercially available medication prescribed within regular practice of the physician. No~     other examination will be performed than would be done without Post Marketing Survelliance~     study.~   "
110282|NCT01612728|"~     Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen~     receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over~     tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast~     cancer. However, approximately half of the women who take this drug will develop significant~     joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine~     should be taken for 5 years, the joint pain can be so troublesome that up to 13% may~     prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of~     recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is~     clearly understood, leaving both doctor and patient rather frustrated.~      The investigators therefore propose to test the hypothesis that AIA can be effectively~     treated by a new clinical algorithm, and that effective treatment of the problem will lead~     to improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical~     pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of~     interventions based on the available evidence. Interventions include acupuncture, pain~     medication, weight bearing exercise, and other commonly used therapies for AIA.~      The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess~     each woman's baseline joint pains via a questionnaire as well as grip strength measurement.~     The investigators will then periodically repeat these tests during AI therapy in order to~     systematically quantify and characterize AIA. Those women who develop AIA during the course~     of the study will be placed on the clinical algorithm, and the investigators will observe~     whether their joint pains significantly improve (as measured by questionnaire and grip~     strength measurement) after institution of the algorithm. The investigators will also~     determine whether their compliance is improved compared to historical controls, and at least~     non-inferior to the women in the study who do not develop AIA. Finally, the investigators~     will measure serum estrogen level at baseline and then periodically during AI therapy to~     investigate whether more dramatic decline in estrogen level after initiation of an AI leads~     to significant AIA and earlier time to onset.~      This study targets a very common cause of pain among breast cancer survivors and aims to~     offer an effective treatment strategy to alleviate pain and improve quality of life as well~     as medication compliance.~   "
110283|NCT01612715|"~     Cat allergies are a major trigger of asthma. Therapies are being developed to control the~     allergic response to cats. We are interested in measuring a type of white blood cell which~     is linked to cat allergies, which will help us understand how to use new therapies in people~     who suffer from cat allergies and asthma. We will study cat-allergic individuals with~     stable, mild asthma who will be exposed to cat allergens. We will measure various white~     blood cells, including the cells that are linked to cat allergies, to determine whether the~     number of these cells changes following cat exposure. These cells will be measured from the~     blood and bone marrow by removing samples using a needle. These cells will also be measured~     from the lungs by inserting a bronchoscope into the airways and drawing up fluid containing~     cells. This study will improve our understanding of the harmful versus protective role of~     these cat-specific cells, and will allow for development of better drugs for treatment of~     asthma triggered by cat exposure.~   "
110284|NCT01612702|"~     This study was conducted to determine the efficacy of an additional preemptive, single,~     low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting~     (PONV), pain level, and the safety in terms of wound complications in patients managed with~     our antiemetic protocol based on Ramosetron following TKA.~   "
110285|NCT01612689|"~     This is a prospective, unblinded sub-study to the E-30 to gather physiological data.~   "
110286|NCT01612676|"~     The purpose of this trial is to investigate the potential of FE 202158 as a treatment which~     can stabilize blood pressure for treatment of patients in early septic shock.~   "
114855|NCT01552798|"~     The purpose of this trial is to determine if a single, oral dose of a fast release aspirin~     1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with~     tension-type headache pain.~   "
110287|NCT01612663|"~     The purpose of this study is to test if specific therapeutic benefits of acupuncture are~     mostly attributable to contextual and psychosocial factors, such as patients' beliefs and~     expectations.The investigators propose using the 2 acupuncture methods, which refrains from~     inserting needles in the affected area, in order to evaluate the short-term and long-term~     efficacy of acupuncture in a clinical setting compared with placebo and compared with~     invasive needling that does not adhere to correct acupuncture rules.~   "
110288|NCT01612650|"~     This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a~     significant decrease of ultrasound cliches (and radiation exposure)~   "
110289|NCT01612637|"~     Purpose The aim of this study is to examine if a structured pelvic floor muscle training~     combined with lifestyle advice with can improve pelvic organ prolapse (POP) symptoms more~     than structured lifestyle advice programme alone.~      Background Pelvic organ prolapse (POP) is a common condition among adult women and almost~     one in ten women experience symptoms caused by POP. The key symptom of POP is seeing or~     feeling a bulge in the vaginal opening but POP often gives other symptoms, such as pain,~     difficulty emptying the bladder or the bowel, incontinence and sexual problems such as~     dyspareunia.~      A majority of women with POP will be offered reconstructive surgery but the risk of~     reoperations is substantial and surgery may cause new symptoms. In one out of four women~     surgery does not relieve symptoms and the women have been exposed to unnecessary risk of~     complications.~      It is therefore important to evaluate the effect of conservative treatments for POP. New~     studies have shown that pelvic floor muscle training offered in combination with lifestyle~     advice has a significant on POP symptoms and objective measures of POP compared to a~     lifestyle advice leaflet alone.~      No studies have compared the effect of a combined pelvic floor muscle training and lifestyle~     advice programme with a structured programme of lifestyle advice and hypothetically the~     structured lifestyle advice programme could have a substantial effect on its own. Our~     hypothesis is that the pelvic floor muscle training is a vital component of a conservative~     treatment for POP.~      Methods In this single-blind randomised controlled study women with POP will randomised to~     either a programme of structured pelvic floor muscle training combined with lifestyle advice~     or a structured lifestyle advice programme alone. Both groups will receive the same~     lifestyle advices through six (separate) lectures within 12 weeks. The training group will~     be examined and individually instructed in pelvic floor muscle training before the~     intervention starts and they will, in continuation with their lifestyle lectures, perform~     pelvic floor muscle training as group training~   "
110290|NCT01612624|"~     Rationale: Acromegaly is the clinical syndrome that results from an excess of growth hormone~     (GH). Craniofacial and hand disproportions due to soft tissue swelling and new bone~     formation are highly prevalent in patients with active acromegaly. Besides the cosmetic~     aspects, these changes can impair the quality of life because of the significant morbidity~     with respect to oral, maxillofacial and hand pathologies as well as respiratory problems~     such as sleep apnea and changes in speech. At present it is unclear if these craniofacial~     and hand disproportions, sleep apnea and speech changes are (partially) reversible after~     successful treatment. Therefore there is no consensus about the information patients should~     be given about (partial) recovery of facial and hand disproportions after treatment and how~     the follow-up with respect to oral, maxillofacial, respiratory and hand pathology should be~     organized. Facial and hand analysis using a 3D stereophotograph and a 3D fusion model of a~     3D stereophotograph and a 3D skull reconstruction via cone beam computed tomography~     (CT)-scan makes it possible to investigate the craniofacial changes due to acromegaly in all~     facial dimensions together (dentition, bone and soft tissue) and the relational proportions~     between these facial structures. 3D stereophotography can do the same for the soft tissues~     of the hand. Combined with disease specific and general quality of life (QOL)~     questionnaires, a correlation between quality of life and craniofacial and hand~     disproportions can be determined. Combined with sleep- and speech analysis, a correlation~     between sleep apnea, speech and craniofacial disproportions can be determined.~      Primary objective: To investigate the changes in facial- and hand analysis in patients with~     acromegaly as a result of medical treatment and pituitary surgery, and to investigate the~     changes in relational proportions between facial- and hand structures, incidence and~     severity of sleep apnea, incidence and severity of speech changes and QOL.~      Study design: a prospective case-control study. Study population: Approximately thirty~     patients newly diagnosed with acromegaly . The results of facial and hand analysis, sleep~     apnea research and speech analysis of the patient group in different phases of the disease~     will be compared to the results of a healthy control group.~      Main study parameters/endpoints: Parameters of facial analysis with 3D stereophotography and~     cone beam CT and hand analysis with 3D stereophotography , biochemical parameters of disease~     activity, disease related QOL assessed by 2 validated QOL questionnaires (,the AcroQol and~     RAND-36 ), speech analysis, the results of the voice handicap index questionnaire and~     severity of sleep apnea assessed by complete overnight polysomnography and the Epworth~     sleepiness scale questionnaire.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: As a result of participating in this study, subjects have to undergo a cone~     beam CT. The cone beam CT is associated with exposure to X-ray radiation of 0.069-0.135mSv.~     This is the same amount of radiation as the amount of background radiation that each person~     receives in 7 days time during daily life. No adverse effects are expected from this amount~     of exposure. The investigations will take 10-70 minutes adjacent to every regular outpatient~     clinic visit. In addition , for polysomnography, subjects will be investigated overnight one~     or three times in 2,5 years, depending on the results of the first screening~     polysomnography.~      Assessment of changes in body appearance, sleep disturbances, speech changes and QOL in a~     prospective longitudinal fashion will increase the knowledge of the impact of the disease on~     patient perception of well-being and functioning and will help us refine the treatment goals~     in patients with acromegaly~   "
110291|NCT01612611|"~     The purpose of this study is to make a cohort event monitoring to see whether and how~     Shenmai injection in hospital results in adverse events or adverse drug reactions.~   "
110292|NCT01612598|"~     Patients enrolled in phase I clinical trials could potentially benefit from palliative care~     concurrently, yet limited evidence is available to support such a change in care. The~     primary purpose of this study is to test the feasibility of a palliative care intervention~     (PCI) for patients participating in a phase I therapeutic clinical trial~   "
110293|NCT01612585|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and~     coronary heart disease in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
110294|NCT01612572|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia~     、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children~     acute hot diseases in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 20,000 patients.~   "
110295|NCT01612559|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and~     angina pectoris in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
110296|NCT01612546|"~     This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating~     patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that~     has progressed through at least one prior regimen of chemotherapy and cannot be removed by~     surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor~     cells and is hypothesized to interrupt the growth of tumor cells.~   "
110297|NCT01612533|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart~     disease in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 20,000 patients.~   "
110298|NCT01612520|"~     The objective of the study is to analyze the effectiveness and the cost-effectiveness of~     telecoching in improving glyceamic control and other modifiable risk factors in patients~     with type 2 diabetes compared to usual care only.~   "
110299|NCT01612507|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     different dose regimens of Ceftaroline~   "
110300|NCT01612494|"~     This single center, blinded, randomized controlled trial evaluated the use of hypertonic~     saline versus normal saline as therapy for the symptoms of pediatric concussion post head~     injury.~      The study hypothesis was that hypertonic saline would improve symptoms of pediatric~     concussion following head injury as measured on the self-reported Wong Baker Faces Pain~     Scale as compared to normal saline.~      The null hypothesis was that there would be no difference in change of reported pain in~     either group.~   "
110301|NCT01612481|"~     Cancer surveillance has a significant cost and generate anxiety for the patient.~      It is important to avoid exams that will not modify health support or whose results wont~     allow to decide.~   "
110364|NCT01611662|"~     The purpose of this research study is to find out what effects, good and/or bad, dose-dense~     (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin~     given before surgery have on patients and their muscle invasive bladder cancer.~   "
110365|NCT01611649|"~     The objective of this study is to determine whether the use of a mix of dairy lipids and~     plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane~     phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula~     containing only lipids of plant origin.~   "
110302|NCT01612468|"~     A randomised, double-blind, placebo controlled study of the effect of liraglutide as an~     additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated~     type 1 diabetes patients.~      Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide~     leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2~     diabetes patients.~      It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight~     or poor glycaemic control (HbA1c > 8 %).~      Small studies, not placebo controlled, reports effects of adding liraglutide to a group of~     well regulated (HbA1c < 7.5 %) normal to overweight insulin treated type 1 diabetes patients~     for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured~     by continuous glucose monitoring was seen.~      Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to~     placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on~     therapy to insulin. Secondary objectives:To investigate the effect of liraglutide as an~     add-on therapy to insulin compared to placebo on change in:Weight, insulin~     dose,hypoglycaemic events, CGM, BMI, body composition, quality of life, treatment~     satisfaction,food preferences, meal test, CIMT, PWV and 24 hour blood pressure.~   "
110303|NCT01612455|"~     The purpose of this study is to implement and assess a behavioral and structural~     intervention in Russia designed to support and motivate HIV-infected narcology heroin~     dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care~     and ultimately improve their HIV outcomes. The central hypothesis is that an intervention~     that involves coordination between the narcology and HIV systems via HIV case management~     delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement~     in HIV care.~   "
110304|NCT01612442|"~     In Ghana the level of malnutrition is high among children below five years of age,~     particularly in rural areas. The objective of the study was to investigate the effects of an~     education intervention aimed at addressing poor complementary feeding (CF) practices on the~     food intakes and growth of young children in the Upper Manya Krobo district of Ghana.~      Interviews and focus group discussions involving community health and agricultural workers,~     as well as caregivers of children 6-24 months old were conducted to investigate the~     facilitators and challenges to optimal CF practices and education on CF. The trials of~     improved practices (TIPs) method was used to test the feasibility and acceptability of~     potential education messages among mothers of young children (6-24 months) living in the~     study area. Child welfare clinic centers in the area were randomly assigned to one of three~     groups which were control, nutrition education and integrated education. Mothers of children~     6-24 months in the integrated education group received monthly nutrition education from~     community health volunteers and agricultural education from agricultural extension agents~     for six months in addition to standard monthly child growth monitoring services from~     community health nurses. Mothers in the nutrition education group received monthly nutrition~     education from community health volunteers for six months in addition to standard care.~     Mothers of 6-24 months in the control group received only the standard monthly child~     monitoring services. The effects of the educational intervention on maternal knowledge on~     optimal complementary feeding, as well as food intakes and growth of young children were~     determined among 367 mother-child dyads over a period of at least six months. The study~     hypothesised that mothers receiving the education would have improved knowledge on good~     complementary feeding practices compared to those in the control group. The study also~     hypothesised that young children in the integrated education would have better nutrient~     intakes and growth compared those in the nutrition education and control groups, and those~     in the nutrition education group would have better nutrient intakes and growth than the~     children in the control group.~      From the interviews and focus group discussions, reported initiation of CF was satisfactory,~     while other reported practices such as the addition of animal source foods, vegetables and~     fruits to young children's diet were found to be sub-optimal. Poverty and maternal time~     constraints were identified as the main challenges of optimal complementary feeding, while~     farming was seen as a facilitator. Lack of education materials, language barrier, maternal~     time constraints and lack of in-service training for health workers were the main challenges~     to education on complementary feeding. From the TIPS study, mothers expressed their~     willingness to improve the diets of their 6-24 months old children by adding or increasing~     the amount of animal source foods, dark-green leafy vegetables and fruits, as well as~     increasing feeding frequency daily. However, availability and affordability of protein-rich~     foods like animal source foods, groundnut paste and soya beans powder was a challenge for~     some mothers.~      The intervention did not lead to a significant improvement in maternal knowledge on~     complementary feeding practices. However, it showed a tendency to reverse a general~     decreasing trend in knowledge among mothers on appropriate complementary feeding practices~     in the study area. Significantly more children in the integrated education group consumed~     animal source foods compared those in the other two groups when compared at nine months~     after baseline. However, the intervention did not improve the general nutrient intakes and~     growth of the young children in the study area.~   "
110305|NCT01612429|"~     This is a pilot study to evaluate the effects of amino acid supplementation on the structure~     of certain proteins in the blood of dialysis patients. Patients with end stage renal disease~     (ESRD) usually have high levels of urea that may interact with blood proteins and change~     their structure by a process known as carbamylation. The investigators are interested in~     determining whether carbamylation is linked to adverse outcomes in dialysis patients and~     have hypothesized that supplementation with a balanced formulation of amino acids can reduce~     the amount of carbamylation that occurs. In this study, dialysis patients (n= up to 30) will~     receive intravenous supplementation with an FDA-approved amino acid solution (NephrAmine®,~     5.4% amino acids) during regular dialysis sessions (3 times weekly for 6 weeks). During the~     6 weeks of therapy and for 2 weeks of follow-up, blood will be drawn from patients' existing~     hemodialysis access ports (~60 ml total per month) to measure levels of carbamylated~     albumin, amino acids, and standard laboratory values. Patients will be closely monitored for~     safety and tolerability of the amino acid therapy. For each treated subject, we will follow~     an additional individual that is not receiving treatment to serve as a control (no~     intervention).~   "
110306|NCT01612416|"~     The aim of this study is to examine whether there is a difference in macular ganglion cell~     complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle~     glaucoma and normal tension glaucoma with spectral domain OCT.~   "
110307|NCT01612403|"~     There are several causes leading to male infertility, like oxidative stress, and nutritional~     deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three~     types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands~     (LMW). The present study was conducted to study the effect of Zn supplementation on the~     quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels~     in semen of patients with asthenozoospmia.~   "
110308|NCT01612390|"~     Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third~     and fourth stages of labor~   "
110309|NCT01612377|"~     This study will compare an experimental drug called Z102 (combination of prednisolone and~     dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to~     severe Rheumatoid Arthritis for a period of 52 weeks.~   "
110310|NCT01612364|"~     This is a double-blind randomized controlled trial to evaluate the efficacy of the~     sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients~     with CRPS I refractory to medical treatment will be subjected to four physical therapy~     sessions and then the randomized for experimental or control block and then more four~     physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary~     outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain~     inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and~     WHOQOL-brief).~   "
110311|NCT01612351|"~     The purpose of this study is to see if a three method risk adapted design using induction~     chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and~     make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.~   "
110312|NCT01612338|"~     The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the~     Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are~     conducting a multidisciplinary academic/practice three-year project to increase appropriate~     breast cancer screening for young breast cancer survivors and their cancer-free, female~     relatives at greatest risk for breast cancer. The aims of this project are to: 1) identify~     and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program~     who were diagnosed between the ages of 20-45 years regarding their breast cancer screening~     utilization; 2) identify and survey the survivors' female relatives regarding their breast~     cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored)~     of an evidence-based intervention recommended by the Guide to Community Preventive Services~     to increase breast cancer screening. A follow-up survey will assess the effectiveness of~     each intervention on a) breast cancer screening utilization; b) perceived barriers and~     facilitators to screening; c) self-efficacy in utilizing screening services; d) family~     support related to screening; e) knowledge of the genetics of breast cancer and personal~     risk factors; and f) satisfaction with the intervention.~   "
110313|NCT01612325|"~     Radioembolisation is a known method for the treatment of liver tumors and or~     livermetastases. Currently small beadlets called microspheres are used that are loaded with~     the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical~     characteristics including good visualisation in gammacameras due to the gamma emission.~     Because of the higher specific activity higher radiation doses to the liver will be used~     compared to the standard Yttrium treatment. It is hypothesized that higher doses of~     irradiation have an improved antitumor effect.~   "
110314|NCT01612312|"~     Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is~     recommended by current guidelines, there are insufficient data to unequivocally support~     thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus~     containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial~     is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The~     hypothesis is that under the background of early revascularization, adjunctive thrombectomy~     in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less~     microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in~     patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two~     treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary~     endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct~     size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow~     post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death,~     myocardial reinfarction, target vessel revascularization and new congestive heart failure~     will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In~     summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy~     will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in~     the culprit vessel reperfused by early PCI.~   "
110315|NCT01612299|"~     Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression~     therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and~     at 6, and 12 months in renal transplantation patients. B. To investigate progression of CAC~     in patients undergoing renal transplantation within the study period.~      Secondary objectives:~        1. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on bone mass as evidenced by changes in quantitative computed~          tomography (QCT) and dual energy X-ray absorptiometry (DXA).~        2. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on activity of bone forming and resorbing cells as evidenced~          by changes in bone histology.~        3. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on biochemical parameters of bone turnover as evidenced by~          changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP),~          Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear~          factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal~          telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide).~        4. To evaluate in renal transplantation the effect of Zortress® versus standard~          immunosuppression therapy on cardiovascular events, graft rejection and patient~          survival.~   "
110316|NCT01612286|"~     The investigators designed this study to evaluate the efficiency and the acute toxicities of~     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic~     nasopharyngeal carcinoma (NPC).~   "
110317|NCT01612273|"~     To explore the efficacy of triflusal in patients with symptomatic peripheral~     microcirculation dysfunction. Triflusal is a salicylate compound approved in several~     countries as antithrombotic agent and it additionally has vasodilatory effect. The~     hypothesis is to explore if there is a improvement of peripheral microcirculation by~     triflusal.~   "
110318|NCT01612260|"~     The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin~     capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.~   "
110319|NCT01612247|"~     Patients with stage II-III breast cancer who do not achieve a pathologic complete response~     to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose~     continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following~     surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with~     secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The~     investigators design tests the null hypothesis (H0) that the true primary toxicity event~     rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.~   "
110320|NCT01612234|"~     High intakes of saturated fat are associated with diabetes. Our work has shown that the two~     most common fatty acids in the North American diet, palmitic acid (saturated fat) and oleic~     acid (monounsaturated fat) are metabolized differently and have opposite effects on fat~     burning. The proposed study will examine biochemical and molecular mechanisms for how a high~     saturated fat diet versus a low saturated fat/high monounsaturated fat diet alters the~     action of the hormone, insulin, in skeletal muscle.~   "
113393|NCT01571960|"~     This study will test the safety and immune responses of a prime-boost regimen of two HIV~     vaccines— a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine— in healthy,~     HIV-uninfected, vaccinia-naive adults.~   "
110321|NCT01612221|"~     This is a phase II intervention to propose a new melanoma chemoprevention agent. The~     investigators believe oxidative stress/damage in nevi is a probable indication for melanoma~     risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi~     from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate~     whether administration of NAC around the time of UV exposure will reduce melanoma risk in~     high-risk patient populations with genetic susceptibility to UV-induced oxidative stress,~     and 2) examine key genetic variants that will identify which individuals are most likely to~     benefit from chemoprotection.~   "
110322|NCT01612208|"~     The objective of this study is to document callus formation and healing of fractures~     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled~     axial micro-motion to actively promote fracture healing.~   "
110323|NCT01612195|"~     Anal abscess-fistula disease is of common occurrence and has a significant impact on the~     quality of life of affected individuals. The course of abscess-fistula disease as well as~     its treatment modalities may affect anal continence. The present cohort study investigates~     the results of anal fistula plug surgery. In particular, this study focus on the impact of~     anal fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty~     patients will be included and followed up at 6 weeks and 6 months after surgery in the~     clinic of participating surgeons.~   "
110324|NCT01612182|"~     The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement~     therapy.~   "
110325|NCT01612169|"~     Primary Objective: This study will evaluate the most effective strategy in achieving HIV~     virologic suppression among HIV-infected substance users recruited from the hospital setting~     who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN);~     2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).~      Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of <= 200~     copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will~     differ from each other at the 12 month follow-up.~      Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of <= 200~     copies/mL) in the PN+CM group will be greater than that in the TAU group.~      Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than~     that in the PN group.~      Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than~     that in the TAU group.~      Secondary Objectives:~        1. To evaluate the effect of the experimental interventions on: HIV virological~          suppression and CD4 T-cell count changes at 6 months post-randomization; engagement in~          HIV primary care and visit attendance; and rate of hospitalizations.~        2. To evaluate the effect of the experimental interventions on: drug use frequency and~          severity; and drug use treatment engagement and session attendance.~        3. To assess selected mechanisms of action of the intervention (.i.e. mediators of~          intervention effect).~        4. To assess potential characteristics associated with differential treatment~          effectiveness (i.e. moderators of intervention effect).~        5. To evaluate the incremental cost and cost-effectiveness of the interventions.~   "
110326|NCT01612156|"~     The purpose of this study is to determine a difference in patient reported pain levels~     before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel~     or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when~     compared to lubricant gel.~   "
110327|NCT01612143|"~     This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess~     the relative bioavailability of setrobuvir as tablet formulation versus the reference~     capsule formulation in healthy volunteers. Subjects will be randomized to one of four~     treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or~     capsule formulation with or without a high fat meal, with a washout period of at least 14~     days between treatments.~   "
110328|NCT01612130|"~     The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg~     in single oral doses one hour preoperative as conscious sedation during the impacted lower~     third molar surgery.~   "
110329|NCT01612117|"~     Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine~     (SCr). New biomarkers are considered for early and sensitive detection of CIN. In~     particular, uNGAL has been used for early detection of AKI in the emergency department,~     after cardiopulmonary bypass or following CM administration.~      This study will be conducted to assess the possible value of urinary Neutrophil~     Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy~     (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP)~     and whether or not uNGAL correlates with the volume of contrast medium (CM) used.~   "
110330|NCT01612104|"~     The purpose of this pilot-study is to evaluate a cognitive behavioral method Psychological~     First Aid used with a group of children (11-16 years) in high risk of developing~     psychological problems. Participants are recruited from a low-threshold program (The~     Children's House in Oslo) where counseling is given to children suspected of being~     physically or sexually abused, or having witnessed domestic violence. The study includes~     twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological~     problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be~     assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms~     of will be assessed daily.~   "
110331|NCT01612091|"~     The Mobile Messenger is a unified, portable and intelligent device that integrates~     information from multiple patient monitors, mechanical ventilators, infusion pumps and~     clinical information systems on a mobile platform. It will allow nurses, respiratory~     therapists and physicians to continuously monitor and coordinate care of critically ill~     patients. This study will use a participatory design process to guide the design of an~     integrated mobile device. Next, we will evaluate the proposed device in a simulated ICU~     setting.~   "
110332|NCT01612078|"~     Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday~     activities in hemodialysis patients. Since information regarding the use of droxidopa in~     clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is~     limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of~     droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.~   "
110333|NCT01612065|"~     Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal~     route is the best, optimum dose not yet known.~   "
110334|NCT01612052|"~     The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides~     coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive~     bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at~     the time of vascular surgery and result in an increased hospital length of stay, increased~     cost of care, and an increased risk of morbidity and mortality as a consequence of surgical~     site infections. Thus, the investigators want to compare whether Methicillin-resistant~     Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is~     superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI)~     following open arterial revascularization procedures requiring a groin plus lower extremity~     incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to~     Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open~     groin plus lower extremity procedures.~   "
110335|NCT01612039|"~     This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled~     study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis~     will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291~     (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.~      The study hypothesis is that treatment with ASP3291 compared to placebo will improve a~     patient's ulcerative colitis endoscopic score from baseline to Week 8.~   "
110336|NCT01612026|"~     In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique~     is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used~     in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass~     graft puncture, and to ensure accurate arterial puncture in patients expected to receive~     large doses of blood-thinning medications during or after the procedure. For those~     practitioners experienced with ultrasound-guided access techniques, it is considered highly~     accurate and easy to use; thus, some physicians routinely use this tool. A well-designed~     study is needed to truly assess the accuracy of the ultrasound technique and to determine~     whether it may reduce complications of arterial access in vascular patients.~      By demonstrating the safest, most accurate and efficient technique for obtaining arterial~     access during catheter-based procedures, the investigators could significantly reduce~     morbidity and mortality associated with complications of arterial puncture. Length of~     hospital stay, management costs and patient discomfort could be reduced by minimizing~     complication rates.~   "
110337|NCT01612013|"~     Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal~     insufficiency and is associated with prolonged hospitalization and unfavorable early and~     late outcomes. The investigators sought to compare 4 different strategies (intravenous~     high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline~     alone) in the prevention of contrast-induced acute kidney injury in patients undergoing~     coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C~     serum levels.~   "
110338|NCT01612000|"~     The purpose of this study is to investigate the safety and immunogenicity of a recombinant~     hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered~     at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted~     rHA formulation.~   "
110339|NCT01611987|"~     Despite the benefits of exercise and physical activity people with Multiple Sclerosis (MS)~     are relatively inactive. Physical activity is important for persons with disabilities to~     maintain physical function. A lack of physical activity can contribute to heart disease,~     osteoporosis, obesity, and diabetes. At the moment, the best way for people with MS to~     exercise and be physical activity is unknown. People with MS report not knowing what to do.~     This is a barrier to exercise.~      The global aim of this study is to contribute evidence for the role of targeted exercise in~     altering MS outcomes over time. The design is a randomized controlled trial (RCT). The~     primary research question is to what extent does an MS Tailored Exercise Program (MSTEP)~     result in greater improvements in exercise capacity and related outcomes in comparison to a~     program based on general guidelines for exercise among people with MS who are sedentary and~     wish to engage in exercise as part of MS self-management. The primary outcome for this~     question is exercise capacity measured using cycle ergometry. However exercise efficiency,~     functional ambulation, strength, components of quality of life including frequency and~     intensity of fatigue symptoms, mood, global physical function, health perception, and~     illness intrusiveness, will also be measured as components of a global response outcome. The~     first confirmatory hypothesis is that MSTEP will result in a greater proportion of people~     making clinically relevant gains (at least 10% change) in exercise capacity than with~     general guidelines after 12 months of intervention; a secondary hypothesis is that, while~     there may be some decline in exercise capacity among individuals from end of intervention to~     follow-up one year later, the decline will be greater in the general guideline group~     augmenting the difference between groups in the proportion making 10% change from study~     entry to 24 months. In other words, gains will be maintained more for the MSTEP group over~     the general guideline group.~      An exploratory hypothesis is that more of the targeted outcomes will improve with the MSTEP~     program than the general guideline approach. An explanatory hypothesis is that these gains~     will be accompanied by reports of greater exercise enjoyment and exercise self-efficacy~     (confidence) with the MSTEP program than with the general guideline program leading to more~     consistent exercise engagement and improved long-term adherence.~   "
110340|NCT01611974|"~     This study will assess safety, antiviral activity, and pharmacokinetics of different doses~     of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are~     resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in~     recipients of stem cell or solid organ transplants.~   "
110341|NCT01611961|"~     Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel~     developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was~     evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients~     with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects~     of DT-LM compared to commerical docetaxel.~   "
110342|NCT01611948|"~     Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in~     10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of~     withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse~     precipitant. Cannabis use also impairs executive cognitive functions thereby increasing~     vulnerability to relapse and reducing the ability to benefit from behavioral therapy. There~     are no pharmacological treatments for cannabis dependence, despite the large number of~     afflicted individuals and the limitations of behavioral therapies which do not remediate~     withdrawal and are associated with high rates of treatment failure. The primary aim of this~     clinical trial is to evaluate the efficacy and safety of a novel neurokinin1 (NK1) receptor~     antagonist, aprepitant (Emend), (125mg/day), in outpatients with current cannabis~     dependence. The main hypothesis to be tested is to evaluate the relative efficacy of~     aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis~     dependent outpatients, specifically anxiety, mood, craving and sleep.~   "
113454|NCT01571167|"~     The primary purpose of the study is to determine the effects of treatment with varenicline~     (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving~     and subjective effects in methamphetamine-dependent human volunteers.~   "
110343|NCT01611935|"~     Trauma patients, who are transfused with multiple blood products to treat shock due to blood~     loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone~     necessary to maintain an adequate blood pressure and low levels have been associated with~     the need for increased transfusions, vasopressors and additional morbidity. Vasopressin is~     routinely used in the ICU to treat septic shock and other disease processes resulting in~     decreased vasopressin levels and low blood pressure. This study will investigate the~     potential benefit of early vasopressin supplementation during the resuscitation of trauma~     patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients~     who receive 6 or more units of blood product within 12 hours of arrival will be randomized~     to receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal~     saline) for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical~     and demographic data will be recorded prospectively.~   "
110344|NCT01611922|"~     The purpose of this study is to assess eyelid margin staining, termed lid wiper~     epitheliopathy (LWE), in three populations. The hypothesis is LWE will be more prevalent in~     symptomatic contact lens wearers than non-symptomatic contact lens wearers and least~     prevalent in asymptomatic non-contact lens wearers.~   "
110345|NCT01611909|"~     This study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol~     (PMD)-rich Corymbia Citriodora oil (Citriodiol®) in children with impetigo. Citriodiol® is~     already known to be effective as an insect repellent and is safe in its topical application.~     The investigators have also found in our laboratory that it is bactericidal against~     Staphylococcus aureus, the bacteria responsible for causing impetigo. Parents are always~     searching for a natural alternative to antibiotics (the current gold standard treatment for~     impetigo), and the investigators believe Citriodiol® could provide this possible~     alternative.~   "
110346|NCT01611896|"~     The purpose of this study is to investigate if selenium supplementation to the standard~     treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a~     fewer people with anti-thyroid treatment failure and faster remission, in terms of better~     quality of life during the first year of treatment and more patients staying in remission.~   "
110347|NCT01611883|"~     This study will examine the effect of ezetimibe on glucose metabolism in participants with~     Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated~     hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to~     the placebo control group.~   "
110348|NCT01611870|"~     The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD~     patients during nocturnal ventilation.~   "
110349|NCT01611857|"~     This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients~     with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined;~     in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is~     hypothesized that the response rate (RR) will be improved from 45% to at least 65% under~     this regimen.~   "
110350|NCT01611844|"~     The only test available for in vivo diagnosis of tuberculosis is the intradermal injection~     of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin~     test).~      The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However,~     this test needs to be performed by trained personnel, presents problem of reproducibility,~     and its interpretation is not well standardized (measure in millimeters of skin induration~     48 to 72 hours after the PPD skin test).~      The new generation BD micro needle used in this study should solve the technical~     difficulties; intradermal administration of tuberculin could then be made by any personnel.~      A non-invasive and objective instrumental method of reading the test will be also tested .~   "
110351|NCT01611831|"~     The main objective is to assess the efficacy of Acceptance & Commitment Therapy (ACT) in~     group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the~     cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as~     anxiety, depression, pain or global function. 3.- To evaluate the usefulness or~     electroencephalographic cordance as a prognostic variable of the treatment.~      HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome~     variables (pain, anxiety, depression, global function) in fibromyalgia, and it is~     cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.~      DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month~     follow-up period. Participants will be randomly allocated to one of two conditions: 1.-~     Group Acceptation & Commitment Therapy or 2.- Treatment as usual by his general~     practitioner. Patients diagnosed of fibromyalgia, according to the American College of~     Rheumatology, will be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two~     tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for~     each group of patients.~   "
110352|NCT01611818|"~     BACKGROUND: Major depression will become the second most important cause of disability in~     2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective~     option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided~     psychotherapy have been carried out.~      AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major~     depression in the Spanish health system.~      METHODS: The study is made up of 3 phases: 1.- Development of a computerised~     cognitive-behaviour therapy for depression tailored to Spanish health system. 2.-~     Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate~     depression recruited in primary care. They should have internet availability at home, not~     receive any previous psychological treatment, and not suffer from any other severe somatic~     or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity~     Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided~     Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI~     psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be~     also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume~     of health and social services). Patients will be assessed at baseline, 3 and 12 months. An~     intention to treat and a per protocol analysis will be performed.~   "
110724|NCT01606943|"~     Clinical profiles and outcomes of patients with acute aortic dissection have not yet been~     evaluated in China. The aim of this study is to establish clinical registry of acute aortic~     dissection in China and to analyze clinical features, managements and outcomes of Chinese~     patients with acute aortic dissection.~   "
110353|NCT01611805|"~     This is an double-blind, single dose, four-period, crossover study in Japanese healthy male~     volunteers to assess the pharmacokinetics and safety/tolerability of single doses of~     GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg~     GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose~     ascending crossover design. Serial pharmacokinetic samples will be collected following each~     dose and safety assessments will be performed. The pharmacokinetics and dose proportionality~     of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and~     1000 mg under fasted conditions will be assessed. In addition, a comparison will be made~     between the pharmacokinetics of GSK1605786 under fed and fasted conditions.~   "
110354|NCT01611792|"~     Low back pain affects 80% of Americans at some time during their lives. Although recovery~     usually occurs within 6 months, there is a 50% recurrence within one year's time. It has~     long been thought that poor control of trunk muscle may lead to abnormal forces across the~     spine, which then damage local spinal structures, thus, leading to low back pain. However,~     the investigators know little about the function of specific trunk muscles in healthy~     subjects during various activities of daily life. Furthermore, the precise muscle~     dysfunction associated with low back pain has not been well characterized at all. In~     addition, the investigators know little about which exercise protocol is most beneficial for~     particular subgroups of people with low back pain. Thus, the purposes of this study are to~     learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises~     might be most beneficial for people with certain kinds of low back pain; and 3) how these~     exercises influence trunk muscle function. By having a better understanding of which trunk~     muscles are affected by low back pain, rehabilitation specialists can design exercise~     programs and therapeutic interventions that are more specific and more effective.~   "
110355|NCT01611779|"~     The objective of this study is to assess the feasibility and safety of tongue suspension~     using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive~     sleep apnea (OSA).~   "
110356|NCT01611766|"~     The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and~     validate the risk model of patient selection criteria in platinum-sensitive recurrent~     ovarian cancer.~   "
110357|NCT01611753|"~     The purpose of this study was to evaluate the immediate effects of red blood cells~     transfusion on central venous oxygen saturation and lactate levels in septic shock patients~     randomized to two different hemoglobin levels.~      The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2)~     and supply (VO2) could be assessed by systemic oxygen variables such as central venous~     oxygen saturation (ScvO2) and lactate levels. Although it is not clear that alterations in~     these parameters actually represent an improvement in the DO2/VO2 ratio, they might~     represent a better transfusion trigger than the absolute hemoglobin value.~      Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL~     , less than 48 hours of shock diagnosis, were included, a central venous catheter in the~     superior vena cava and signed informed consent. The investigators randomized all patients~     into two groups. Patients in the liberal group received transfusions immediately, as the~     objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group,~     transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL.~      Each time a patient received a transfusion, the investigators collected a set of laboratory~     tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately~     before transfusion and one hour after its ending.~      The sample size was calculated by considering that in 80% of the transfusions in patients in~     the restrictive group ScvO2 would improve compared to only 45% of those in the liberal~     group, with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of~     5% over the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be~     necessary, but to correct for potential non-parametric distribution of the main variables,~     the number was adjusted to 35 transfusions in each group.~      Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators~     defined improvement when ScvO2 reached 70% in patients with baseline levels below this~     threshold or when there was an absolute increase of at least 5% after transfusion. Any~     increase in patients with previous ScvO2 ≥ 70% was considered to be no change. Worsening~     was defined as a reduction of 5% in the previous levels or a decline to less than 70% in~     patients with pre-transfusion levels in the range of 70 to 75%. The investigators also~     carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin~     levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose~     ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators~     used a different approach because it would also be necessary to analyze patients with a~     lower chance of response to assess the prediction of response. Thus, this analysis included~     all patients with ScvO2 below 75%, rather than only those below 70%. As before, the~     investigators defined improvement as any increase ≥ 5%. The investigators did not consider~     patients with levels above 75% in this analysis, as the physiological interpretation of this~     situation is challenging. The investigators considered as altered any lactate levels above~     1.5 times the reference level, and a change ≥ 10% was defined as improvement or worsening.~     In patients with baseline normal levels, the status was recorded as worsening if a 10%~     increase was detected. Afterwards, the investigators tested the association between these~     categorized variables and the baseline levels of hemoglobin. The impact on perfusion was~     also assessed by the determination of Δlactate (lactate post-transfusion x 100/lactate~     pre-transfusion) and ΔScvO2 (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their~     correlation with the baseline hemoglobin levels was analyzed using the Spearman correlation~     test.~      In all tests, the results were considered significant if the p level was lower than 0.05.~   "
110358|NCT01611740|"~     Hospital-acquired infections are common complications in preterm infants. The diagnosis has~     to be fast and accurate. Indeed, the early identification of a suspected infection is very~     important, since the early administration of antibiotics lowers the risk of septic shock and~     improves long term outcome in the infected newborns who survive. Besides, a high specificity~     in the diagnosis of infection allows for the reduction of inappropriate treatment and thus~     prevents the emergence of antibiotic resistance.~      The aim of this study is to develop a computer-assisted diagnosis tool, based on the real~     time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of~     infection of the preterm infant, at the bedside.~   "
110359|NCT01611727|"~     Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical~     issue. There are emerging data which suggest that mutation carriers may respond differently~     than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary~     cancers for a range of pathologic and molecular factors, including tumor grade and~     histologic appearance. Several studies have shown that the response to treatment for women~     with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular,~     the impairment of the DNA damage response and repair pathways, and that it is possible to~     exploit the sensitivity of BRCA1-associated cancers to DNA damage.~      It is equally important that the investigators evaluate the benefit of cisplatin in women~     with disseminated breast cancer, including those who have previously been treated with one~     or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of~     cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary~     objective is to determine the objective response rate of cisplatin in BRCA1 carriers with~     metastatic breast cancer. The secondary objectives are to determine 3-year survival and to~     evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.~   "
110360|NCT01611714|"~     This study will 1) Develop two interventions: a) an audit-feedback email intervention that~     provides clinicians with data on CT scan ordering practices by patient race; and b) a~     clinical decision support (CDS) message in the electronic medical record headache template;~     and 2) Compare the effectiveness of these 2 interventions in eliminating a previously~     observed Black-White disparity in CT scanning rates to rule out subarachnoid hemorrhage~     (SAH).~   "
110361|NCT01611701|"~     The aim of this prospective randomized double-blind study was to compare the efficacy and~     safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after~     failed first radiofrequency ablation.~   "
110362|NCT01611688|"~     This trial is conducted in Europe. The aim of this trial is to describe the safety and~     tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in~     subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.~   "
110363|NCT01611675|"~     This research study is a Phase I/II clinical trial. Phase I clinical trials test the safety~     of an investigational combination of drugs. Phase I studies also try to define the~     appropriate dose of the investigational drug combination to use for the Phase II portion of~     the study, which will enroll more participants and continue to study the effects of the drug~     and the safest dose. Investigational means that the combination of vemurafenib and~     leflunomide is still being studied and that research doctors are trying to find out more~     about it. It also means that the FDA has not approved this drug combination for your type of~     cancer.~      Genes are a specific part of your cell materials which send code messages to determine what~     the investigators bodies look like, such as eye color, and instruct cells to control growth~     and development of the body. Researchers have found that a large number of melanoma cells~     have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow.~     Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change~     into cancer cells, in which case, the cells keep dividing and growing out of control.~     Specifically, it has been shown that vemurafenib blocks the effects of these mutations in~     the BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved~     vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be~     removed by surgery (unresectable) or that has spread (metastatic).~      Leflunomide is in a class of medications called disease-modifying antirheumatic drugs~     (DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to~     decrease inflammation in that setting. However it is not approved for treatment of melanoma.~     The researchers of this study believe this agent may help prevent cancer growth as well as~     enhance the properties of drugs that target the BRAF gene (such as vemurafenib) based on~     recently published laboratory research, and would like to learn more about any effects this~     combination may have on your disease.~      The main purposes of this study are to determine the highest dose of vemurafenib and~     leflunomide that can be given in combination without causing severe side effects, to see~     whether the combination of vemurafenib and leflunomide is safe in participants with BRAF~     mutant metastatic melanoma and to learn if the combination of vemurafenib and leflunomide~     shows any signs of effectively treating your disease.~   "
110366|NCT01611636|"~     The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are~     different all over the world. The relative impact of gene and environment on diseases can be~     revealed by studies from different populations. National Health Insurance database in Taiwan~     provides a wealth of epidemiology study, which can contribute to the understanding of these~     diseases. However, national health care database did not contain test results and clinical~     details. The database of the hospital records can provide complimentary clinical details.~     Via the comparison of databases of the National health Institutes and the investigators~     hospital, the investigators hope that the characteristics and outcomes of these patients can~     be better understood.~   "
110367|NCT01611623|"~     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90. It is being evaluated for safety in patients with~     cancer.~   "
110368|NCT01611610|"~     The aim of this project is to establish a network of clinical teams including the major~     neuromuscular centers in Europe.~      We plan to work together to find the best common outcome measures for the following~     multicenter therapeutic trials.~   "
110369|NCT01611597|"~     Validation of a measure specifically suitable to evaluate the residual function of upper~     limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy~     and spinal muscular atrophy.~      This approach is of fundamental importance for clinical monitoring and preparing the future~     therapeutic trials.~   "
110370|NCT01611584|"~     The purpose of this trial is to measure ALA-induced fluorescence in both normal and~     malignant tissue.~   "
110371|NCT01611571|"~     The purpose of this study is to develop new treatment options for osteoporosis in men. The~     Investigators will study two medications and three treatment regimens. First, risedronate~     (FDA approved) will be studied as monotherapy. Second, the investigators will study~     injectable parathyroid hormone (PTH 134, teriparatide; FDA approved), as a therapy for male~     osteoporosis. PTH, a naturally occurring hormone produced by the parathyroid glands, is one~     of the most important regulators of bone metabolism. The drug being studied in this~     protocol, teriparatide, is the first aminoterminal 34 amino acids of the native 84amino acid~     peptide. Teriparatide contains all of the classical biological activities of native PTH. In~     studies of postmenopausal women, in a small study of 23 men with osteoporosis and a larger~     study of 437 men treatment with teriparatide led to significant increases in bone density.~     Although teriparatide and actonel are now approved for osteoporosis in men additional~     studies of these medications are needed in order to establish how best to use these drugs.~     This study is focused on an entirely new treatment approach, namely the combination of two~     medications for the treatment of osteoporosis risedronate with teriparatide to evaluate~     whether combination therapy is superior to therapy with either medication alone. This study~     is also designed to assess the extent to which risedronate maintains increases in bone~     density after a course of mono or combination therapy.~   "
110372|NCT01611558|"~     To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall~     response associated with ipilimumab treatment~   "
110373|NCT01611545|"~     The aim of this biospecimen repository is to evaluate an individual's genotype, identify the~     variances, and understand how they relate to treatment with clopidogrel.~   "
110374|NCT01611532|"~     Acute pancreatitis is a multi-system disease with an unpredictable clinical course and~     significant morbidity and mortality Approximately 20% of patients develop multi-organ~     failure requiring management within a critical care environment However much of the~     pathophysiology of the disease, particularly understanding why some patients develop~     life-threatening disease whilst others have a relatively benign course, remains unclear.~      It well recognised that intra-abdominal hypertension (IAH) is a cause for organ dysfunction~     in critically ill patients and is associated with higher morbidity and mortality rates~     (Sugrue et al., 1999). Abdominal compartment syndrome (defined as an increase in~     intra-abdominal pressure (IAP) >20mmHg) is associated with new organ failure (Malbrain et~     al., 2006). The mechanisms believed to contribute to IAH in acute pancreatitis include~     increased capillary permeability, hypoalbuminaemia and volume overload (third space~     losses), producing retroperitoneal and visceral oedema (Dambrauskas et al., 2009).~      Several small studies have recently described the link between intra-abdominal hypertension~     and adverse outcome in acute pancreatitis ( Dambrauskas et al., 2009; de Waele et al.,~     2005), however none of the authors appreciate the potential predictive value of there~     conclusions or the potential as a target for therapeutic intervention to alter the disease~     course.~      This study aims to study the natural history of intra-abdominal pressures in acute~     pancreatitis and determine whether they truly do have a predictive value or whether they are~     simply another marker of organ failure in a multi-system disease with notoriously poor~     outcome.~   "
110375|NCT01611519|"~     Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery~     with an epidural catheter in place?~   "
110376|NCT01611506|"~     RATIONALE: Radiotherapy is currently the most efficient way to induce pathologic responses,~     which are associated with a favorable prognosis in localized tumors. Novel radiotherapy~     techniques are associated with significantly less toxicity than traditional radiation~     protocols and permit to avoid the toxicity to adjacent organs. Established chemotherapy~     regimens, such as cisplatin and capecitabine, and monoclonal antibodies, such as cetuximab,~     can block tumor growth in different ways. Giving radiation therapy together with cisplatin~     and cetuximab before surgery aims to induce a pathological response and improve the~     prognosis after surgery.~      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy~     when given together with cisplatin and cetuximab in treating patients who are undergoing~     surgery for locally advanced gastric cancer.~   "
110398|NCT01611220|"~     Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to~     a healthy level, but high percentage of patients relapse during the first year following the~     discharge. The development of strategies to overcome this problem represents a priority for~     clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program~     based on cognitive dissonance theory developed for hospitalized patients.~   "
110399|NCT01611207|"~     The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or~     Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic~     Subcutaneous Abdominal Wound healing-impairments (ISAW).~   "
110377|NCT01611493|"~     A potential complicating factor affecting implants is crestal bone loss. The causes of~     crestal bone loss are attributed to several factors. Among those hypothesized, proof for one~     or another cause remains obscure. Clinical documentation suggests that implant design may be~     a key factor. While the evidence is inconclusive, various authors suggest that it is a~     result of a combination of effects including (1) limited drilling procedure and restricted~     second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design~     for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the~     absence of a significant microgap 6.~      The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant~     seating surface physically moves the inflammatory cell infiltrate zone away from the crestal~     bone). The growing body of anecdotal platform switch evidence supports this biological width~     hypothesis. Here the biological width refers to the height of the dento-gingival attachment~     apparatus around a normal tooth and is defined as the distance necessary for a healthy~     existence of bone and soft tissue from the most apical extent of a dental restoration.~      To formally test this hypothesis the current study has been designed. The Prevail implant~     has been made with an integrated medialized seating surface that establishes a platform~     switching function. This implant moves the implant/abutment interface away from the crestal~     bone and may therefore reduce the amount of bone loss observed in the standard~     (non-medialized) Osseotite implant design. The objective of this study is to evaluate~     crestal bone levels adjacent to the implant reference point from the time of implant~     placement to a period of two years after loading.~   "
110378|NCT01611480|"~     The aim is to evaluate efficacy and safety of three different dosing regimens of Limtop in a~     study involving 96 patients with actinic keratosis on the head or face.~   "
110379|NCT01611467|"~     Part 1: To characterize the biotransformation and excretion of CC-223 following a single~     20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in~     healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral~     dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male~     adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics~     (PK) of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect~     of a high-fat meal on the PK of M1, the principal pharmacologically-active metabolite,~     following a single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of~     CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.~   "
110380|NCT01611454|"~     The PREFER II trial primary objective of the trial is to show how much radiation attenuation~     is provided by XPF thyroid collars in absolute and relative terms.~   "
110381|NCT01611441|"~     The main purpose of the study is to better understand how specific proteins/markers in~     blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the~     joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to~     investigate if there is a correlation between x-ray results, specific proteins/markers and~     different types of pain in patients with osteoarthritis of the knee. The study consists of 3~     visits over 3-20 days and the last visit will be the day of surgery.~   "
110382|NCT01611428|"~     A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.~   "
110383|NCT01611415|"~     A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions~     between furosemide and ipragliflozin (ASP1941) in healthy volunteers.~   "
110384|NCT01611402|"~     Background:~      - Tuberculosis (TB) infection is particularly deadly when it happens in people who are also~     infected with the human immunodeficiency virus (HIV). However, not much is known about how~     these two infections affect each other. Some people who have HIV or TB infections develop~     health problems after they start taking either HIV or TB medications or both. These drugs~     can improve the body s ability to fight infections, but sometimes this sudden improvement~     can make the infected person initially become sicker. Researchers want to study how these~     infections affect the immune system and the gene expression of people who have TB and may or~     may not have HIV, to see if there is a pattern of gene expression that may predict whether~     people starting treatment may get sicker initially.~      Objectives:~      - To study the gene expression and immune systems of people with TB who may or may not also~     have HIV.~      Eligibility:~        -  Adults at least 18 years of age who have tuberculosis.~        -  Participants will be drawn from study sites in the United States and China.~      Design:~        -  Participants will be divided into three study groups. The first group will have TB but~          not HIV. The second group will have both TB and HIV that have not been treated. The~          third group will have both TB and HIV that are currently being treated.~        -  All participants will have a single study visit. Blood samples will be collected at~          this visit. A medical history will also be collected.~        -  No treatment will be provided as part of this study.~   "
110385|NCT01611389|"~     The aim of this study is to evaluate the effect of minimizing right ventricular pacing in~     dual-chamber pacemaker patients with sinus node disease (SND) and first degree~     atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure~     measures.~   "
110386|NCT01611376|"~     The investigators validated ICG's(impedance cardiography) usefulness during the abdominal~     surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)~   "
110387|NCT01611363|"~     In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and~     T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and~     plasma glucose in T2DM subjects will be investigated.~   "
110400|NCT01611194|"~     Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen~     therapy for persistent post-concussive symptoms after mild tramatic brain injury~   "
110401|NCT01611181|"~     Hemoboost is a registered natural product containing specially processed haemolysed~     haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use~     and documented effect in veterinary medicine. Iron dextran was introduced for use in human~     medicine in 1954.~      Krauterblut is a registered natural product made from a number of herbs where the active~     substance is ferrous gluconate. Both drugs have been available for a number of years and~     have become increasingly popular among patients and healthcare staff due to a reduction in~     adverse effects.~      The objective of this study is to determine the effect and adverse effects of the natural~     products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate~     in knee arthroplasty.~   "
110388|NCT01611350|"~     The purpose of this study is to determine the effectiveness of different sales offers and~     different marketing messages to increase the uptake of energy efficient cookstoves.~      This research will address the following major barriers to the acquisition and correct use~     of improved cookstoves into four main categories:~        -  Inappropriate product or marketing for intended users~        -  Lack of consumer trust in new products~        -  Failure to address consumers' financial constraints~        -  Failure to achieve behavioral change~      To do so this research includes 3 Randomized Controlled Trials including:RCT 1- Testing the~     Effectiveness of Marketing Messages in Increasing Willingness to Pay; RCT 2- Testing the~     Effectiveness of the Novel Sales Offer and its ability to Increase Uptake of Purchasing~     Energy Efficient Cookstoves; and RCT 3-Measure the Effects of Fuel Efficient Cookstoves on~     Health, Fuel Use and Time Spent Collecting Fuel.~      RCT 1 studies the price women are willing to pay for the improved stove. It will also test~     the effects of the two most effective marketing messages identified during the Phase 1~     Feasibility stage (e.g., improved health, saves time, and has high status) on increasing~     willingness to pay. RCT 1 will run second price auctions in 36 parishes with an average of~     60 participants per meeting.~      From RCT 1, RCT 2 tests the effect of a Novel Sales Offer- which includes a free trial, and~     time payments- on purchasing decisions of participants versus those that receive the~     Traditional Offer- a cash and carry offer. Based on a pilot in urban Kampala conducted by~     Dr. David I. Levine (co-P.I. on this project) results show a 44% uptake for households~     offered the novel offer vs. a 4% uptake for those offered the traditional offer. The~     hypothesis is a novel offer will significantly increase uptake of fuel efficient cookstoves~     in rural Uganda when compared to a traditional offer.~      RCT 3 measures the impacts of fuel efficient cookstoves on health, fuel usage, and time~     spent collecting fuel. For RCT 3 we will randomize those who accept the Novel Offer into~     early and late groups. To measure the impacts of improved stoves on health, fuel use, time~     spent collecting fuel, etc., there will be a baseline and follow-up survey and associated~     quantitative measures on our full sample and a small endline on select quantitative measures~     for a sub-sample.~   "
110389|NCT01611337|"~     Therapeutic alliance, and drug observance are major difficulties in the care of persons~     presenting schizophrenic symptomatology. They appear to be linked to insight, the~     consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it,~     but usually without using specific evaluation tool. Insight is usually not evaluated during~     care, and its evolution is also not known, although it is highly probable that a positive~     evolution of insight for a person in hospital correlated to an adapted and optimal care by~     the medical and nursing teams. The investigators do not know examples of insight evaluation~     during a sequence of hospital care, or any evidence of insight variation in relation to~     evolution abilities of some schizophrenic patients cared in hospital.~      The investigators propose here to evaluate insight in people presenting schizophrenia or~     related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better~     characterize insight variations, and identify the sociodemographic, clinical and therapeutic~     variables linked to it.~   "
110390|NCT01611324|"~     The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2%~     mepivacaine+epinephrine solution, can be effective in reducing the pain associated with~     local infiltration anesthesia, during ambulatory phlebectomy procedures.~   "
110391|NCT01611311|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in healthy young and elderly male and female volunteers following oral~     administration of repeated rising doses, given once daily over 14 days to young healthy~     genotyped and elderly healthy male/female volunteers.~   "
110392|NCT01611298|"~     This research study is for subjects that are receiving a bone marrow transplant. As part of~     the transplant subjects will receive stem cells from a donor who has agreed to donate stem~     cells for them. Unfortunately, it takes a long time for the immune system to recover after a~     bone marrow transplant. This makes it more likely for patients to develop serious~     infections.~      This study is being done to better understand how the immune system will recover after~     transplant. The immune system includes the cells that help fight infection. This study will~     help investigators understand which patients are at risk for developing infections after~     transplant.~      All children and adults receive standard vaccines (shots) during their lifetime to provide~     protection from many different infections. One such infection is tetanus, a bacteria that~     can cause life-threatening problems. After transplant patients no longer have protection~     from infections such as tetanus. Therefore, most patients need to receive all their vaccine~     (shots) again after transplant. This is usually done 1-2 years after transplant, since it~     may take that long for patients to have a normal immune system.~      However, the investigators believe that the time it will take for the patient to develop~     normal protection against tetanus can be shortened if both the patient and the patient's~     stem cell donor receive a tetanus vaccine.~      The goal of this study is to determine if giving a tetanus vaccine to the donor and the~     patient will provide the patient with enough protection (immunity) to prevent infection~     following bone marrow transplant.~   "
110393|NCT01611285|"~     Within the general objective of investigating optimal medical techniques for pelvic prolapse~     repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more~     cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision~     analysis as the comparative strategy~   "
110394|NCT01611272|"~     To identify the following items through the post marketing surveillance under routine~     clinical practice after marketing authorization of Brilinta Tablet: the occurrence of~     unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events~     (AEs), the factors that may influence safety and efficacy of the drug.~   "
110395|NCT01611259|"~     This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus~     Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated~     Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.~   "
110396|NCT01611246|"~     The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the~     Acclarent Iontophoresis System with Earset (IPSES).~   "
110397|NCT01611233|"~     DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a~     higher than expected revision rate reported in the England/Wales and Australian national~     joint registries. There are two types of ASR hip implants used for total hip replacement~     surgery:~        -  ASR XL Hip System~        -  ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the~          study sponsor. MGH is conducting this study with the help of funding from DePuy~          Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects~          around the world. The countries include the United States of America, Australia, South~          Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test~          results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH~          will analyze the data annually for 6 years.~      The purpose of this study is to follow patients who have the ASR hip system for the next 6~     years. The findings of this study may help surgeons to make better informed decisions about~     monitoring and treatment of patients with ASR hip systems.~   "
110402|NCT01611168|"~     The proposed research study aims to determine whether applying the University of Pittsburgh~     Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved~     clinical outcome and process measures as recommended by American Diabetes Association (ADA),~     quality of life, treatment satisfaction and medication adherence for adults with diabetes,~     and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the~     cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care~     settings will also be assessed.~   "
110403|NCT01611155|"~     You are being asked to take part in this research study because you are going to be treated~     with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes~     neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the~     effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on~     oxaliplatin-induced neuropathy (numbing, tingling and/or pain)~   "
110404|NCT01611142|"~     The primary objective of this study is to determine the overall response rate of KW-0761 for~     the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is~     the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are~     considered to play a role both in the recruitment of immune and inflammatory cells for~     anti-tumor response and in the selective homing of neoplastic B and T cells.~   "
110405|NCT01611129|"~     The purpose of this study is to determine whether the use of 'patient journey' model in~     internet-based counseling of a person with hearing impairment is a feasible approach in~     management of emotional and social consequences, anxiety and depression, readiness to change~     and acceptance of hearing loss.~   "
110406|NCT01611116|"~     Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic~     leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a~     consequence, refractory disease and relapse frequently occur in AML, especially in elderly~     patients. The investigators propose that the addition of temsirolimus may improve standard~     AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating~     cells in AML, thereby reducing the risk of leukemia relapse.~      The study's main part is preceded by a open label run-in part, in which optimal temsirolimus~     dose and schedule for the main part o the study will be determined.~   "
110407|NCT01611103|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to~     deliver very weak electrical current to the surface of the scalp while participants complete~     cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults~     over the age of 55.~   "
110408|NCT01611090|"~     The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in~     combination with bendamustine and rituximab in patients with relapsed or refractory chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
110409|NCT01611077|"~     The investigators want to find out if a treatment with a new combination of two different~     antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately~     elevated blood pressure is more effective than treatment with just one substance~     (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve~     comparable baseline conditions. Treatment is then started with the single substance. After~     six weeks, therapy is changed to another single substance and after a further six weeks, to~     the fixed combination tablet. Blood pressure is determined by office measurements taken by~     the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may~     be male or female and must be over 18 years of age.~   "
110410|NCT01611064|"~     Hand surgery requires a reduced blood flow to the hand during the operation, which is~     achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm.~     However this tourniquet is painful. This study investigates whether breathing oxygen can~     reduce the pain associated with the tourniquet to both improve patient experience and~     potentially to allow longer operations to be completed under a local anaesthetic (rather~     than a general anaesthetic, where the patient is put to sleep, which is more costly, time~     consuming and risky for the patient).~   "
110411|NCT01611051|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase~     2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma~     half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to~     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia~     following chemotherapy in patients with breast cancer.~   "
110412|NCT01611038|"~     The primary objective of this study is to determine if vitamin supplementation with a~     naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine)~     can restore disruption of circadian rhythm in shift workers.~   "
110413|NCT01611025|"~     This is a retrospective, multicentre, observational study to assess the trends in antibiotic~     utilization and hospital ecology with respect to susceptibility patterns of selected~     bacterial isolates to the utilized antibiotics.~   "
110414|NCT01611012|"~     The purpose of this study is to determine the type and degree of inflammatory parameters in~     peripheral blood of asthma patients compared to analysis of induced sputum.~      115 asthma patients visiting the outpatient clinic of the University Medical Center will be~     included. Blood samples are obtained and sputum induction is performed.~      Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by~     changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained~     from induced sputum~   "
110415|NCT01610999|"~     In order to keep our immune systems healthy over our lifetime, certain cells in the bone~     marrow and lymph nodes called stromal cells nurture the immune cells and protect them from~     damage. Stromal cells and blood cells communicate using a protein called SDF1a. The~     investigators think that cancer cells including lymphoma and multiple myeloma can trick the~     stromal cells into helping them avoid damage from chemotherapy by using SDF1a.~      Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the~     Federal Drug Administration (FDA) for use in humans to help release blood stem cells from~     the bone marrow for use in transplantation. The use of plerixafor to interrupt communication~     between stromal cells and cancer has not been approved by the FDA and is experimental.~   "
110417|NCT01610973|"~     The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front~     of the eye.~      When the eye becomes opaque, the eye is not seeing and the only way to restore the visual~     acuity is to replace the cornea by performing a graft (4000 surgeries per year in France).~     In half the cases the opacification of the cornea is secondary to dysfunction of the~     endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of~     regulating the moisture of the corneal thickness and therefore its transparency.~      While the total corneal transplantation has long been the only intervention for these~     diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called~     endothelial transplant or graft lamellar later. This intervention is now experiencing~     significant success as it reduces very significantly the incidence of complications found~     after transplantation of total cornea and the visual recovery period. This type of~     transplant is still difficult to achieve and the best technique is not yet established.~      Indeed, posterior lamellar transplantation of the cornea may be done manually or using an~     automated device. Manual techniques allow the preparation of grafts extremely thin but are~     difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may~     be less efficient in visual recovery.~      The aim of this project is to conduct a prospective study in order to compare these two~     techniques in terms of postoperative visual recovery and the vitality of the graft during~     the first year. To date, there is no such study.~      The department of Ophthalmology in the University Hospital of Rouen is one of the most~     famous French teams in the field of cornea transplants and receives many patients from~     different French regions. The recruitment of 40 patients needed to study should be done~     without great difficulty over a period of 18 months.~   "
110418|NCT01610960|"~     Noninvasive ventilation (NIV) is a well established, safe, and effective technique in~     improving gas exchange while reducing dyspnea and inspiratory effort in patients with either~     hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to~     endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory~     failure, are the tolerance to the interface used and the ability of the interface to unload~     inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of~     NIV for longer periods, while face mask has been proved to be more efficient at iso-support~     in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT~     (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better~     compliant wall, that avoid the use of armpit braces potentially improving, compared to the~     standard helmet, both pressurization and patient-ventilator interaction and tolerance. The~     objective of this study is to compare the effects of NIV delivered via face mask, standard~     helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and~     comfort.~   "
110419|NCT01610947|"~     Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or~     infliximab), and in stable low disease activity for at least 6 months, will be randomized~     into 2 groups: either keeping on their usual treatment with stable doses or progressive~     spacing of injections of their treatment. Follow-up will be done every 3 months during 12~     months, with regular monitoring of disease activity and, in patients from the group~     spacing, modification of the rhythm of injections according to health state and predefined~     protocol.~   "
110420|NCT01610934|"~     The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in~     patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.~   "
110421|NCT01610921|"~     Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial~     tree including the small airways (<2mm). Since the introduction of the solution~     hydrofluoroalkane (HFA) technology it is possible to generate medication with small~     particles of approximately 1-2 μm, and therefore to reach the small airways. However, at~     this moment the investigators have no reliable instruments to identify the asthmatic~     subjects who particularly benefit from treatment with inhaled small particles. Recently the~     investigators research group investigated whether provocation with small and large particles~     AMP is able to identify responders and non-responders to treatment with small and large~     particles of inhaled corticosteroids. This provocation technique gave promising results but~     needs further optimization.~      The aim of this study is to determine the optimal particle size of dry powder adenosine to~     assess small airway involvement in asthma. Secondary, to provide insight in the associations~     between the standard test, executed with nebulized AMP, and the new test, executed with dry~     powder Adenosine.~   "
110422|NCT01610908|"~     The primary aim of this multicenter randomized controlled trial is to compare the effect of~     a 6 month Schroth exercise program combined with standard-of-care to standard-of-care~     alone on scoliosis curve severity measured using the Cobb angle.~      Secondary aims include:~        1. To determine the effect of Schroth exercises at 6 months on secondary outcomes~          including quality-of-life, spinal appearance, objective posture and spinal muscle~          endurance measurements.~        2. To determine the efficacy of 6 months of Schroth therapy offered to control~          participants after completing 6 months in the standard-of care group (using subjects as~          their own controls)~        3. To determine if the effects of the 6 months supervised Schroth exercise program can be~          maintained after supervised therapy is terminated.~      At Hopital Ste-Justine, the following secondary aims will be pursued to examine the~     preliminary evidence about the effect of Global Postural Re-education (to satisfy the local~     ethics committee request because Global Postural Re-education exercises were offered~     routinely to patients at that institution prior to the trial).~      A. To compare the effect and to quantify the treatment effect sizes of 6 months of Global~     Postural Re-education exercises with North American standard Care consisting of only~     observation and bracing to Schroth exercises combined with North American standard care~     and to North American standard care alone on scoliosis curve severity measured using the~     Cobb angle.~      B. To estimate the effect and quantify the treatment effect sizes of 6 months of Global~     Postural Re-education exercises with North American standard Care to Schroth exercises~     combined with North American standard care and to North American standard care alone on~     outcomes including quality-of-life, perceived spinal appearance, objective posture and~     spinal muscle endurance measurements.~      C. To determine if the effects of Global Postural Re-education exercises with North~     American standard Care can be maintained after discontinuing supervision.~      D. To estimate the feasibility of conducting a randomized trial focused on Global Postural~     Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise~     sessions and compliance with the home exercises prescribed.~   "
110423|NCT01610895|"~     The objective of the study is to examine the effect of adding a strict low-residue lunch on~     the day before colonoscopy has on clinical efficacy and patient tolerability of bowel~     preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage.~      The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient~     satisfaction~   "
110424|NCT01610882|"~     This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's~     recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps~     determine what medication they need. Traditionally, this involves asking the child to rate~     their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to~     one of a series of faces on a piece of card. The Panda uses the same methods, but presents~     them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain~     scores as the traditional methods.~   "
110425|NCT01610869|"~     The primary objective is to explore the efficacy and safety of an all oral combination of~     BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in~     patients with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two~     lines of previous chemotherapy and who for any reason are not suitable for further~     'standard' intravenous chemotherapy treatments.~   "
110795|NCT01606020|"~     The effects of sleep deprivation (SD) on performance, while contradictory at first glance,~     are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal~     versus prolonged exercises. This latter type of exercise leads to the most important~     performance decrements after SD.~   "
110426|NCT01610856|"~     Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy.~     However, due to the nature of cleansing process, the ideal bowel cleansing preparation~     remains elusive.~      The objective of this study is to compare the efficacy, safety and tolerability of oral~     polyethylene glycol lavage given either as a single dose or split dose. The study will be a~     randomized controlled single blind two group study. The primary study outcomes will be the~     previously validated Ottawa bowel preparation score.~   "
110427|NCT01610843|"~     The aim of this study is to collect information about the clinical course and~     characteristics of sarcoidosis patients around the world through web-based surveys.~     Recruitment is directed at and driven by patients in the sarcoidosis community. This will~     allow the the investigators to study sarcoidosis patients across all demographic,~     geographic, and socioeconomic boundaries, not just patients seen at large research centers.~     The investigators believe this study can give investigators a broader and less biased view~     of sarcoidosis. The investigators would also like to collect genetic samples on this~     population to assess genetic variance in different phenotypes.~      The information for the study would be provided through a web based survey system that can~     be accessed by patients or physicians of patients from any computer with Internet access.~     This system would collect clinical information in sufficient detail so that the phenotype of~     individual patients can be evaluated. Upon agreeing to participate in further research~     studies through the website, subjects will also have the opportunity to provide a DNA~     sample.~   "
110428|NCT01610830|"~     Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is~     considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is~     characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation.~     These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western~     countries. In recent years, considerable progress has been made in understanding the~     pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year~     or the presence of severe glomerular inflammation on renal biopsy remain predictors of long~     term renal function. Moreover, the high variability of HSP clinical expression, from few~     purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal~     failure, remains so far unexplained but suggests the existence of individual genetic~     susceptibility.~      In the first part of the study, we will study key factors based on physiopathological data~     obtained by our laboratory as well as by other groups. The second part of the study concerns~     genetic factors. Although the candidate genes that may confer a particular susceptibility to~     the disease, to progress to ESRD or respond to treatment are many, the genes involved in~     inflammation or controlling renin-angiotensin system are of particular interest.~      We will apply these results by studying patients with HSP showing three distinct phenotypes~     (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at~     diagnosis and after clinical remission.~      The purpose of this study is to assess whether the phenotype at diagnosis is associated with~     the physiological markers and if one of them predicts a pejorative evolution of renal~     disease at 1 year. Meanwhile, study of polymorphism of selected genes of interest could~     allow identification of patients with specific genetic susceptibility or with bad prognosis~     factors who would be thus eligible for specific treatment.~   "
110429|NCT01610817|"~     Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50%~     of these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs. A~     common underlying factor of such events is inadequate communication between patients and~     medical personnel. General practitioners (GP) often initiate the treatment of hypertension,~     being generally the first prescribers of these medications. 12.6% of the patients present an~     ADE with hypertensive drug after 3 months. The InPAct procedure is a tool to facilitate~     communication in order to improve patient safety in primary care. In the context of the~     primary care prescription of an antihypertensive drug, the GP informs the patient about~     hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs,~     which helps the patient to detect and declare situations involving a heightened risk of~     antihypertensive-related ADEs. The aim of the InPAct study is to evaluate the efficiency of~     the InPAct intervention in primary care.~   "
110430|NCT01610804|"~     The purpose of this study is to determine changes in choroidal thickness in patients with~     Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis~     via Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).~      Study hypothesis: Since exudative changes in the choroid seem to constitute the primary~     pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present~     and be visible using EDI-OCT.~   "
110431|NCT01610791|"~     This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an~     inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive~     RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6~     infusions).~   "
110432|NCT01610778|"~     This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2~     diabetes on medication.~   "
110433|NCT01610765|"~     This study is to identify if a Novel Antiviral Drug could be used to treat babies with~     Herpes Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the~     investigators will identify the best dose for young children as well as identify additional~     safety information about the Novel Antiviral Drug.~   "
110434|NCT01610752|"~     The purpose of this study is to determine how to help manage weight gain during pregnancy.~     This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in~     expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in~     overweight and obese pregnant women.~   "
110435|NCT01610739|"~     This study aims to examine the effect of carpal tunnel release on blood flow to the median~     nerve using SPY scope imaging to view the perfusion to the nerve.~   "
110436|NCT01610726|"~     The purpose of this study is to evaluate the health cost and clinical outcome by introducing~     enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.~   "
110437|NCT01610713|"~     An open-label extension study in which patients with multiple sclerosis received GW-1000-02~     [named Sativex® in Canada and also named Sativex® Oromucosal Spray] for four weeks in an~     open-label manner.~   "
110438|NCT01610700|"~     A study to compare the efficacy of GW-1000-02 [named Sativex® in Canada and also named~     Sativex® Oromucosal Spray] with placebo in relieving five key symptoms of Multiple Sclerosis~     after six weeks of therapy.~   "
110439|NCT01610687|"~     An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02~     treatment in multiple sclerosis.~   "
110981|NCT01603589|"~     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)~     extracorporeal circulation on perfusion characteristics and remote end-organ protection~     (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting~     (CABG).~   "
110440|NCT01610674|"~     OBJECTIVE/RESEARCH QUESTION Optimising glycaemic control during hospital stay reduces rate~     of infections, length of stay and mortality,in particular in surgical patients. In~     guidelines and literature recommendations on optimal perioperative diabetes care are~     described. Nevertheless, in daily practice, perioperative glycaemic control is very often~     not achieved. This study aims at developing an implementation strategy that is tested on~     feasibility to improve perioperative diabetes care in terms of effectiveness, experiences~     and costs.~      DESIGN/OUTCOME MEASURES/IMPLEMENTATION STRATEGY A step-wise implementation model is applied:~     1) recommendations on optimal perioperative diabetes care (e.g. the administration of~     intravenous insulin, encouragement of diabetes self-management) are systematically~     translated into quality indicators; 2a) using these quality indicators, current care is~     measured by performing a medical record search among 400 patients in 6 hospitals; 2b)~     barriers and facilitators for optimal care are measured by performing interviews with~     professionals and, e.g. regarding self-management, with patients; 3) based on this~     information an implementation strategy is developed;4) implementation activities are enacted~     and 5) evaluated in a controlled before-after design in 6 hospitals providing before and~     after intervention 400 patients.~      DATA ANALYSIS To obtain an indication of the effectiveness of the strategy, baseline and~     post intervention outcomes of intervention hospitals are compared with outcomes in control~     hospitals, using the quality indicators. Experiences of participants in the intervention~     hospitals will be measured to, if necessary, adapt the strategy to make it more effective~     and acceptable.~      ECONOMIC EVALUATION A cost analysis of the implementation strategy will take place.~     Implementation costs will be related to the difference in percentage of patients treated as~     described in the quality indicators before and after implementation. Information on the~     costs and effects at the patient level will also be compared before and after the~     implementation of the recommendations on optimal care.~   "
110441|NCT01610661|"~     The aim of this study is to determine the effect of habituation to diets with different~     types of carbohydrate (simple-carb, refined-carb, unrefined-carb) on selected Cardiovascular~     Disease (CVD) risk indicators.~   "
110442|NCT01610648|"~     The study is being conducted to test the ability of a simple questionnaire to detect mild,~     moderate or severe obstructive sleep apnea. The investigators are also investigating whether~     adding the size of the neck and waist can add to the accuracy of the questionnaire.~      The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The~     investigators hope to enroll 250 patients in our study at Tufts Medical Center.~   "
110443|NCT01610635|"~     It is hypothesised that the number of donations made by English blood donors will be greater~     with reduced vs. standard inter-donation intervals. The null hypothesis is that there will~     be no difference in donations between treatment groups; this may arise if reduced~     inter-donation intervals result in a greater number of donation deferrals (due to low~     haemoglobin) and/or an unacceptable burden to donors.~   "
110444|NCT01610622|"~     Presently there is no apparatus, clinically available, for routine determination of cardiac~     output (CO) in children. The goal of this research is to develop new technology that will~     help determine CO in neonates.~   "
110445|NCT01610609|"~     Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by~     race and low socioeconomic status. Statins have been shown to decrease the risk of~     cardiovascular events among individuals with high CVD risk. Yet, despite increased statin~     use and overall declining CVD rates, disparities in statin use and disparities in the~     control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.~      Objective: To improve the appropriate use of statins for primary cardiovascular disease~     prevention among high risk individuals at community health centers through a system of~     population health management that uses electronic health record (EHR) data to identify~     patients for targeted education and outreach.~      Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for~     myocardial infarction or coronary death of 10% or higher to determine if the population~     health management intervention, compared to usual care, results in higher rates of~     documented statin treatment discussions within 6 months (primary process outcome), higher~     rates of statin prescribing within 6 months (secondary process outcome), and higher rates of~     significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up~     LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).~      Aim 2: Interview patients who received the intervention to identify barriers to success~      Aim 3: Assess the overall costs of the intervention and the costs per each patient who~     achieves significant LDL-C lowering compared to patient who received usual care.~   "
110446|NCT01610596|"~     This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to~     determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied~     twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible~     subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or~     Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed~     50 grams.~   "
110447|NCT01610583|"~     Background:~        -  Health literacy means being able to understand basic health care information. This~          information can include drug labels and prescription instructions. It can also include~          doctor s instructions. Better health literacy can help improve a person s health~          outcomes.~        -  Many minorities have low health literacy. Latinos in particular have both low health~          literacy and poor health outcomes. Language barriers such as poor reading skills can~          contribute to problems with health literacy. Researchers want to develop a new health~          literacy measuring tool. This tool will focus on genetic literacy, which involves~          understanding personal risk of health problems. The tool will be written in Spanish.~          The study will work with Spanish-speaking Latinos to develop and test this genetic~          literacy tool.~      Objectives:~      - To develop a Spanish-language tool to study genetic literacy.~      Eligibility:~      - Spanish-speaking Latino adults between 18 and 75 years of age.~      Design:~        -  Participants will be screened with a brief interview. No personal samples will be~          needed.~        -  Participants will complete the genetic literacy questionnaire. It will be given in~          Spanish.~        -  The tool will ask about participants personal and family health history. It will also~          ask about their understanding of genetic terms and genetic testing. Other personal~          information, such as level of education, will be collected.~        -  Participants will receive a gift card for completing the survey.~        -  No treatment or genetic counseling will be provided as part of this study.~   "
110485|NCT01610076|"~     This is a single-center, randomized control trial of a code status video as an educational~     tool in the intensive care unit. Subjects are stratified by patient or surrogate and are~     randomized to either watch an educational video on code status or not watch the video. They~     are then asked knowledge base questions regarding code status as well as questions~     pertaining to comfort regarding code status. Participants randomized to watch the video are~     also asked questions related to acceptance of the video.~   "
110796|NCT01606007|"~     The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS~     -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin~     (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of~     this treatment will also be studied.~   "
110448|NCT01610570|"~     Background:~      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted~     against some forms of cancer, but was never accepted as a treatment. Research suggests that~     it may be useful against some solid tumors, particularly Ewing sarcoma. Researchers want to~     see if mithramycin can be used to treat solid tumors in children and adults. It will be~     tested in different groups of people, including those with a type of Ewing sarcoma that~     contains a chemical called Ewings sarcoma - friend leukemia integration 1 transcription~     factor (EWS-FLI1).~      Objectives:~      - To see if mithramycin is safe and effective against solid tumors and Ewing sarcoma in~     children and adults.~      Eligibility:~        -  Children and young adults between 1 and 17 years of age with solid tumors that have not~          responded to standard treatment.~        -  Adults at least 18 years of age with EWS-FLI1 Ewing sarcoma that has not responded to~          standard treatment.~        -  Children and young adults between 1 and 17 years of age with EWS-FLI1 Ewing sarcoma~          that has not responded to standard treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor tissue samples will be used to~          monitor the cancer before treatment. Individuals with solid brain tumors will not be~          eligible.~        -  Participants will receive mithramycin every day for 7 days, followed by 14 days without~          treatment. Each 28-day round of treatment is called a cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the drug for as long as the side effects are not~          severe and the tumor responds to treatment.~   "
110449|NCT01610557|"~     Background:~        -  Diabetic macular edema is a common eye complication of diabetes. It causes the blood~          vessels in the retina at the back of the eye to leak, causing swelling. The macula is~          the center part of the retina that is important for seeing fine details and for tasks~          such as reading, driving, or sewing. Swelling of the macula leads to vision loss and~          possible blindness. Inflammation may play a role in diabetic macular edema. It is also~          possible that there is a problem with the blood vessels and the blood supply to cells~          of the retina.~        -  A chemical in the body called vascular endothelial growth factor (VEGF) is important in~          the formation of blood vessels in the body. Lowering VEGF levels may help treat~          diabetic macular edema by reducing abnormal leaking blood vessels in the eye. Drugs~          that can lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been~          shown to help treat diabetic macular edema. Researchers want to see if one of the drugs~          works better than the other.~      Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for~     diabetic macular edema.~      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at~     least one eye.~      Design:~        -  Participants will be screened with a physical exam and medical history. A full eye exam~          will be performed. Blood and urine samples will be collected.~        -  One eye will be selected as the study eye to receive treatment. If both eyes are~          affected, both eyes may be enrolled in the study and receive different drug treatments.~        -  The main part of the study will last for 9 months. At each study visit, participants~          will have physical exams and eye exams. They will answer questions about their health~          and any side effects from the drugs.~        -  Participants will be assigned to one of four groups. Two groups will have two series of~          ranibizumab and one series of bevacizumab shots. The other two groups will have two~          series of bevacizumab and one series of ranibizumab shots. A series is three eye~          injections of the same drug every 4 weeks. The injections will be given at these study~          visits. The series order will vary for the different groups.~        -  After 9 months, participants will continue to have additional study visits. If the~          treatment seems to be successful, the study doctor may increase the time between~          visits. Study injections may be given as needed every 4 weeks for up to 3 years.~        -  Participants may have laser treatments in a study eye if needed. After being in the~          study for 1 year, they may also have steroid injections or other treatments as directed~          for the macular edema.~   "
110450|NCT01610544|"~     Background:~      - Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans~     are used to detect tumor responses to cancer treatment. However, it may be difficult to~     detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These~     scans cannot easily show a difference between remaining cancer cells and inflammation.~     Researchers want to try a new PET/CT scan tracer that may be able to show the difference~     between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are~     still actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are~     responding to early stages of treatment.~      Objectives:~      - To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer~     response to treatment.~      Eligibility:~      - Individuals at least 18 years of age who are being treated for lung cancer or thymoma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood, urine,~          and tumor tissue samples will be collected.~        -  Participants will have two PET/CT scans on separate days before starting chemotherapy.~          One scan will be with a standard radiotracer. The other will be with the 18F-FLT~          tracer.~        -  About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT~          scans on separate days. Additional blood samples will be collected at this time.~   "
110451|NCT01610531|"~     Melanoma is nowadays an important public health problem because its growing incidence. Mass~     screening for melanoma is not recommended worldwide because of its low cost-effectiveness.~     Nevertheless targeted screening for patients at high risk for melanoma is promoted. This~     study is designed to assess the effectiveness and the acceptability of a melanoma targeted~     screening of melanoma, to estimate the risk function to develop a melanoma among patients at~     high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma~     targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a~     registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk~     according to the SAMScore were proposed a skin examination by their GP every year.~   "
110452|NCT01610518|"~     The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to~     the viscosity of the solution in which the fibre is solubilized. To our knowledge, no~     studies have investigated the effect of β-glucan solutions on glycemic response when~     concentration, and thus viscosity, is varied by changing the solution volume but not the~     β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan~     solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.~   "
110453|NCT01610505|"~     The purpose of the post-market study is to demonstrate that the KineSpring System is~     non-inferior to high tibial osteotomy in safety and effectiveness in the treatment of~     symptoms associated with osteoarthritis of the medial compartment of the knee.~   "
110486|NCT01610063|"~     While the ultimate goal of this project is to show an improvement in patient outcomes, this~     pilot study will be used to evaluate the feasibility of introducing the pharmacogenomic~     algorithm to a new setting that does not routinely use the algorithm. Secondary outcome data~     will be collected to generate meaningful estimates of the magnitude of potential treatment~     effects. The trial is designed to occur within the Franciscan Skemp Healthcare System in La~     Crosse, Wisconsin and Arcadia, Wisconsin over the course of 12 months. A novel method of~     delivering the genetic testing results to the physician will be utilized and evaluated. This~     novel method is a system which will deliver results faster and give more guidance for the~     selection of medication.~   "
110487|NCT01610050|"~     This study will evaluate safety and tolerability to determine the MTD/RD.~   "
110454|NCT01610492|"~     This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety~     and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R)~     autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the~     relationship between biomarkers, autoantibody status and clinical response. 10 milligrams~     per kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then~     every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive~     IMGN followed by a further long term treatment period until subjects reach remission of~     proteinuria, up to a maximum of 2 years total treatment. All subjects will receive~     background supportive therapy throughout the study. The dosing frequency will be adjusted to~     every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio~     (PCR) is greater than 1000 milligrams per millimole (mg/mmol) [greater than 10 grams(g)/24~     hours (h)], to compensate for loss of belimumab in the urine. Effects on mechanistic markers~     will be measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various~     other measures of kidney function. These will be compared to historical data. The~     pharmacokinetics of belimumab will be measured to confirm dosing in heavily proteinuric~     subjects. Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects~     will also be investigated. Safety will be assessed by adverse events (AE), clinical~     laboratory evaluations, and vital signs.~   "
110455|NCT01610479|"~     This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid~     tumors.~   "
110456|NCT01610466|"~     Laparoscopic bariatric surgery is an advanced laparoscopic procedure with a potential for~     significant morbidity and mortality along the early part of a surgeon's learning curve.~     Simulation-based training has been shown to improve a surgeon's technical performance and~     shorten the learning curves in the operating room. Despite these benefits, there is no~     evidence-based ex-vivo training curriculum for laparoscopic bariatric surgery. The purpose~     of this study is to design and validate such a curriculum. This curriculum will include~     cognitive training, technical laparoscopic skills training (laparoscopic gastrojejunostomy~     and jejunojejunostomy) and non-technical skills training in a simulated environment. The~     investigators will assess the effectiveness of the proposed curriculum by conducting a~     randomized single blinded controlled trial. Cognitive knowledge (multiple choice test),~     technical skills (performance of a procedure in the operating room) and non-technical skills~     (performance in a simulated crisis scenario in a simulated environment) will be compared~     between curriculum trained and conventionally trained groups. The investigators hypothesize~     that curriculum trained group will have superior knowledge, technical skill and~     non-technical skills compared to conventionally trained group.~   "
110457|NCT01610453|"~     Objectives~        1. To assess if head-perineum distance and angle of progression measured with~          transperineal ultrasound by the obstetrician on call can predict delivery mode in~          primiparous women with prolonged first stage of labour.~        2. To compare ultrasound assessments and clinical examinations.~   "
110458|NCT01610440|"~     Duchenne muscular dystrophy (DMD), an X-linked recessive genetic disease always progressed~     slowly，tends to leading proximal skeletal muscle atrophy and weakness of limbs, as well as~     impaired respiratory muscle and cardiac muscle. To a large extent, patients always lose~     motor function gradually and die for heart failure or severe infection at the end stage of~     DMD. At present, the treatment strategy relies on heteropathy accompanied with~     rehabilitation training. However, the therapeutic effect remains extremely limited.~      Human umbilical cord mesenchymal stem cells (hUC-MSCs) have been evidenced to improve motor~     function, increase muscle strength and reduce abnormal levels of related enzymes, such as~     creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and~     aspartate aminotransferase (AST). This study is aimed to explore the safety and efficacy of~     hUC-MSCs transplantation for DMD.~   "
110459|NCT01610427|"~     The purpose of this study is to investigate a combined set of parameters deemed to impact~     the quality of CMI analyses in terms of the proportion of viable lymphocytes in~     antiretroviral therapy-naïve HIV-1 infected subjects.~   "
110460|NCT01610414|"~     The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine~     GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell~     transplant recipients 18 years of age and older. To this end, the study will evaluate~     vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule,~     compared to placebo in reducing the risk of developing HZ in this population.~   "
110461|NCT01610401|"~     In acute myocardial infarction early restoration of coronary blood flow is the most~     effective strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates~     myocardial injury and contributes to final infarct size, a process termed 'reperfusion~     injury'. Ischemia and reperfusion (IR)-induced endothelial dysfunction seems to play a~     pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the~     already ischemic tissue. Recently, it has been shown that the glucose-lowering drug~     metformin is able to limit IR-injury in murine models of myocardial infarction, probably by~     increased formation of the endogenous nucleoside adenosine. In the current research~     proposal, the investigators aim to translate this finding to the human in vivo situation,~     using flow-mediated dilation (FMD) of the brachial artery as a well-validated model of~     (endothelial) IR-injury.~   "
110462|NCT01610388|"~     This first time in human (FTIH) study will be the first administration of GSK1322322 as an~     intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in~     healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for~     determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma~     concentrations to evaluate drug penetration in the lung. The study will evaluate the~     absolute bioavailability of an oral tablet formulation as compared to the IV formulation.In~     addition, Amendment 01 will enable the investigation of an improved IV formulation~     (GSK1322322J mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic~     cohort.~   "
110488|NCT01610037|"~     The study will assess the long-term safety of the fixed combination product QVA149 versus~     placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary~     Disease (COPD) patients with moderate to severe airflow limitation.~   "
110797|NCT01605994|"~     Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8~     ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and~     Pharmacokinetic (PK) measures~   "
110463|NCT01610375|"~     The aim of this study is to investigate the feasibility, safety and accuracy of a telephone~     follow-up for women previously treatment for endometrial cancer.~      To achieve this aim, potentially eligible women attending the Queensland Centre for~     Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for~     endometrial cancer will be recruited by this study. The study aims to recruit all new~     patients as well as all patients who return to QCGC for their follow-up and who had~     treatment within the previous 2 years.~      The proposed project will involve generation of an evidence-based checklist of signs and~     symptoms of disease recurrence from a thorough literature review. The generated symptom~     checklist will be pilot tested and the refined symptom checklist will be used to follow~     study participants over a period of 12 months.~      During the follow-up period, the basic standard of follow-up after primary treatment for~     endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be~     altered; however, the study participants will be interview via telephone 2 to 5 days prior~     to their scheduled review dates.~      The main outcome measure will be the estimated recurrence rate as derived from the telephone~     assessment and this will be compared to the clinically detected recurrences as recorded in~     patients' medical files.~      It is hypothesized, that the telephone follow-up will identify 90% of all recurrences~     correctly that are later confirmed during the clinical follow-up.~      In addition to the main outcome, we will also assess patients' satisfaction with each of the~     follow-up programs, whether or not lifestyle behaviours were queried and support offered to~     improve wellbeing.~   "
110464|NCT01610362|"~     Dosage of rabies immune globulin was calculated from the victim's body weight, then the~     amount of rabies immune globulin would be injected as much as possible to all of the wounds.~     Increase dosage of rabies immune globulin was needed in situation of multiple severe~     bite-wounds especially among children whose had lower body weight than adults. Our study~     would be conducted in order to determine whether the increase dosage of rabies immune~     globulin would interfere with the protective antibody levels against rabies.~   "
110465|NCT01610336|"~     This study will assess the safety and efficacy of escalating doses INC280 when added to~     gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET~     pathway and who have failed after benefiting on a prior treatment with either gefitinib or~     erlotinib.~   "
110466|NCT01610323|"~     In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the~     development of co-morbid conditions such as hypertension, maternal and childhood obesity,~     gestational diabetes, pre-eclampsia, cesarean section and delivery of~     large-for-gestational-age infants (LGA).~      The aim of this study is to test the hypothesis that obese, pregnant women following a~     supervised moderate intensity physical conditioning program during the 2nd trimester of~     pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as~     compared to women in the control group. We will also conduct a pilot study on the~     feasibility to examine the effects of the intervention on maternal fitness and neonatal~     anthropometry.~   "
110467|NCT01610310|"~     The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and~     tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or~     prefilled syringe (PFS) in healthy volunteers to support the development of the~     autoinjector.~   "
110468|NCT01610297|"~     This was a prospective, single-arm, multicenter, national, phase II clinical study. The~     purpose of this Phase II study was to examine the safety and efficacy of deferasirox to~     decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia~     major.~   "
110469|NCT01610284|"~     The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant~     is effective and safe in treating patients with hormone receptor-positive, HER2-negative~     locally advanced or metastatic breast cancer refractory to aromatase inhibitor.~   "
110470|NCT01610271|"~     Airborne particles are present in all indoor environments including the operating room. Most~     of these particles come from the surgical staff moving around in the room, positioning of~     the patient during surgery, and the movement of surgical equipment and supplies. While the~     amount of particulate in an operating room is much, much less than is found in a typical~     home or public space, some particulate is usually present no matter how the room and air are~     cleaned and filtered. Typically these few particulate cause no problems, but the goal is~     always to have the cleanest air possible during surgery. The Air Barrier System (ABS)~     consists of a reusable blower and a sterile nozzle. The blower feeds filtered air into the~     sterile disposable nozzle, which disperses a constant stream of gentle, high purity air over~     the surgical incision. This stream of air forms a shield over the surgical area to prevent~     airborne particulate from settling into the open wound. This is particularly critical for~     long-duration surgeries, such as procedures that involve the implantation of a prosthesis.~     The main objective of this research study is to determine whether the ABS can reduce the~     potential for surgical site infection during total hip replacement, spinal fusion, or lower~     extremity bypass grafting procedures. These procedures were chosen because each is a~     long-duration procedure which involves implantation of prosthesis.~   "
110471|NCT01610258|"~     The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level~     modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in~     women hospitalized for PPROM.~   "
110472|NCT01610245|"~     This study is a global multicenter randomized factorial double-blind, placebo-controlled~     trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered~     orally twice daily for five days compared to a placebo in the treatment of acute~     uncomplicated influenza and (ii) efficacy and safety of combination therapy with~     nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days~     compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy~     (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.~   "
110473|NCT01610232|"~     The investigators hypothesis is that the infrared-LED illumination during treadmill training~     can enhance physical performance in postmenopausal women. The basis for such a hypothesis is~     based on the fact that the light therapy during the intense metabolic stage caused by~     exercise may be more efficient.~   "
110798|NCT01605981|"~     This is an open label, non randomized, prospective, multicenter, phase II clinical trial~     evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients.~      Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily~     (800mg/day)~   "
110474|NCT01610219|"~     The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a~     concerning public health trend. There has been little research testing ways to prevent the~     development of this disease in children who are at increased risk to develop T2D. This study~     tests a family treatment program that treats 4-8 year old children who are at risk for T2D~     because they are overweight and have a family history of the disease. Sixty at risk children~     and their parents were assigned to one of 2 treatment conditions. Half of the families~     (randomly determined) received an intensive family treatment program that trains parents in~     how to increase healthier foods choices and physical activity for themselves and their~     children using behavior modification strategies. Children receiving this treatment were~     allowed to taste new fruits and vegetables used a pedometer to record how far they walked~     every day, and were given a tool box of toys and interactive games which promoted physical~     activity. The other half of the families only received instruction about healthier choices,~     but received no behavioral modification strategies or physical activity promotion tools.~     Improvements in children's body weight, blood measures, and behavior patterns were measured~     after treatment ended (6 months) and then again after 12 months. The results may lead to a~     better understanding of how family members can positively influence young children's~     behaviors to help prevent T2D. The objective of proposed study was to test a family-based~     intervention designed to reduce excess body weight, improve metabolic and cardiovascular~     profile, and improve diet and physical activity levels in 4 - 8 year old youth who are at~     risk for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.~      Primary Hypotheses:~        1. Compared to children receiving NPA, children receiving LMDP will show greater~          reductions in excess body weight, greater improvements in metabolic and cardiovascular~          measures, improved diet, increased physical activity, and reduced television viewing.~        2. Greater reductions in child excess body weight will be associated with greater~          improvements in metabolic and cardiovascular measures.~      Secondary Hypotheses:~        1. Compared to parents receiving the NPA intervention, parents receiving the LMDP~          intervention will show greater reductions in BMI.~        2. Greater improvements in parent BMI will be associated with greater improvements in~          child body composition, metabolic and cardiovascular measures, and behavioral outcomes.~        3. Compared to families receiving the NPA intervention, families receiving the LMDP~          intervention will show an increase in the number of fruits and vegetables and lower~          energy density foods stored at home.~   "
110475|NCT01610206|"~     Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common~     cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian~     cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients~     with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib~     is a novel agent has recently been approved for the treatment of subjects with advanced~     renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other~     cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy~     and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine,~     for recurrent or persistent ovarian cancer. This is an open label study in which subjects~     will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with~     pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21~     day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day~     cycle. All subjects will be monitored for toxicity and other indicators of safety (labs,~     physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be~     followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The~     primary endpoints of the study are progression free survival and overall survival, which~     will be assessed at three years.~   "
110476|NCT01610193|"~     PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and~     the gut. There is evidence from experimental and clinical trials that the levels of PSP in~     the blood rise in the presence of inflammation or infection. What is not yet well known~     about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in~     predicting appendicitis in patients that present at the emergency room with abdominal pain~     and a clinical suspicion of appendicitis.~   "
110477|NCT01610180|"~     With conventional treatments (i.e. iv Ig, steroids) the overall response rate of ITP~     secondary to LPD is generally lower than in primary ITP, and usually not higher than 50%~     (95% CI 27-72). Eltrombopag which has proved very effective in primary ITP could be~     effective also in ITP secondary to LPDs.~      This novel ITP specific treatment might spare these patients not only from bleeding risk but~     also from toxic or inappropriate cytotoxic therapies, not otherwise demanded by the burden~     of the underlying disease.~   "
110478|NCT01610167|"~     The study is intended to verify through clinical measurement that the NUPRO Sensodyne~     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended~     relief up to 28 days.~   "
110479|NCT01610154|"~     1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon~          release and improve glucose control in Chinese type 2 diabetic.~        2. There are different effects of Sitagliptin therapy on blood glucose regulation,~          pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight~          (BMI>25) Chinese type 2 diabetics.~        3. The purpose of this study is to determine whether glucagon release may contribute over~          30% to the hyperglycemia in Chinese type 2 diabetics.~   "
110480|NCT01610141|"~     The purpose of this study is to determine whether pharmacogenetic guided dosing of warfarin~     is promising for the improvement of efficiency, therapeutic efficacy, and, especially,~     safety of warfarin therapy than a dosing regimen without the pharmacogenetic information in~     Chinese patients initiated on warfarin anticoagulation.~   "
110481|NCT01610128|"~     The aim of the project is to develop a patient reported outcome instrument to assess disease~     control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.~   "
110482|NCT01610115|"~     To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine~     aminotransferase (ALT) levels during pregnancy~   "
110483|NCT01610102|"~     The primary objective of this study is to collect long term clinical follow-up data on all~     patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0~   "
110484|NCT01610089|"~     The urea cycle consists of a series of chemical reactions through which the body converts~     toxic waste- nitrogen into a substance called urea that can be disposed of easily. While~     disposal of nitrogen is the major function of the urea cycle, recent research has shown that~     some enzymes of the urea cycle are also important for the production of nitric oxide. Nitric~     oxide is an important chemical that has many functions in the human body including~     regulation of blood pressure. Through this study, the investigators will study the~     production of nitric oxide in subjects with citrullinemia type 1 by administering stable~     isotopes to these subjects. Stable isotopes are harmless compounds that can be used to track~     and measure the production of specific compounds in the human body. The overall goal of this~     study is to understand if citrullinemia patients have a deficiency of nitric oxide~     production. This knowledge may have an impact on the treatment of patients with~     citrullinemia.~   "
110489|NCT01610024|"~     Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung~     disease.~      Using the already established pulmonary rehabilitation model, we aim to split the group of 8~     into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on~     alternate (differing) weeks to see if it improves their overall exercise tolerance.~   "
110490|NCT01610011|"~     The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla~     to measure brain glycine levels noninvasively at baseline and for 2 hours after a single~     oral dose of a concentrated glycine-containing beverage, and to compare MRS glycine~     measurements to glycine blood levels in samples obtained after each MRS spectrum.~      The investigators hypothesize that they will observe a high correlation between the~     magnitude increases in brain and plasma glycine levels over this time frame.~      The investigators also hypothesize that we will observe large intersubject variability in~     glycine uptake rates into brain and blood.~      The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC)~     mutation (triplication) will have lower baseline plasma and brain glycine levels and will~     experience smaller brain and plasma glycine increases after glycine consumption than~     controls or family members without the GLDC mutation.~   "
110491|NCT01609998|"~     This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to~     evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the~     2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV~     vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The~     hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a~     broader and more durable immune response than is observed in age-matched comparator TIV-TIV~     groups.~   "
110492|NCT01609985|"~     The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute,~     prospective, non-randomized multi-center feasibility clinical trial. The purpose of this~     clinical trial is to collect data to assist in the testing and finalization of a hemodynamic~     sensor-based cardiac resynchronization therapy (CRT) optimization scheme.~   "
110493|NCT01609972|"~     The purpose of this investigational study is to establish the safety and effectiveness of~     electrical stimulation delivered to the spinal cord in subjects with chronic, intractable~     pain of the trunk and/or limbs and will be a comparison of the Senza System with~     commercially available SCS systems.~   "
110494|NCT01609959|"~     The purpose of this study is to compare blood pressure lowering effect of azilsartan with~     that of valsartan in Japanese patients with hypertension who have already taken normal-dose~     angiotensin II receptor blockers.~   "
110495|NCT01609946|"~     The study is an open, prospective multicenter study. According to the statistical sample~     size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the~     study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or~     histology obtained by surgery.~      All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland,~     as well as Realtime Elastography of thyroid nodules.~      Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate~     the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.~   "
110496|NCT01609933|"~     A study to evaluate the safety and effect of treatment with experimental antiviral drugs in~     combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who~     did not respond to treatment in a previous AbbVie/Abbott combination study.~   "
110497|NCT01609920|"~     The aim of this study is to examine the diagnostic performance of gadofosveset enhanced~     magnetic resonance imaging lymphography (MRL).~      The diagnostic performance of MRL will be determined on the basis of a node-to-node matching~     of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel~     lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the~     golden standard for nodal involvement.~   "
110498|NCT01609907|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and~     valsartan in healthy male volunteers.~   "
110499|NCT01609894|"~     The proposed research will investigate individualized fortification of breast milk based on~     daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind~     controlled trial. The combination of additional fat, carbohydrate and protein and commercial~     fortifier will be added to ensure that the milk contains the target amounts of nutrient.~     Growth and development of these infants will be compared with that of infants fed mother's~     milk that has been supplemented with the current standard amounts. The postnatal growth of~     the infants will be assessed by measuring weight, length and head circumference and fat and~     lean mass using highly accurate, non-invasive methods throughout the intervention period and~     at the first follow-up visit after discharge at 3 months. Neurological development will be~     analyzed at the age of 18 months.~      The investigators hypothesize that individualized fortification of breast milk improves the~     nutritional intake of preterm infants, optimizing growth, and thus this will positively~     impact neurodevelopment and health.~   "
110500|NCT01609881|"~     Objective of the research study:~        1. To measure anterior chamber and vitreous ketorolac (Acuvail®) concentrations after~          topical administration in patients undergoing routine vitrectomy to determine the~          ability of the medication to penetrate into the anterior chamber and vitreous cavity,~          and to compare these levels to the IC50 for the cyclooxygenase-1 and -2 enzymes (COX-1~          and COX-2)~        2. To measure vitreous concentrations of prostaglandin subtypes (PGE, PGD, PGF) and other~          inflammatory mediators (Interleukin-1β [IL-1β], IL-6, IL-8, tumor necrosis factor~          [TNF]-α, VEGF) in both diabetic and nondiabetic patients undergoing vitrectomy~        3. To determine if topical ketorolac (Acuvail®) can penetrate the anterior chamber and~          vitreous cavity sufficiently to decrease levels of intraocular inflammatory mediators~          that have been shown to be elevated in diabetic patients~        4. To serve as a precursor to a 5-year longitudinal clinical trial to determine if~          chronically administered topical ketorolac (Acuvail®) can prevent, delay or slow~          diabetic retinopathy.~      Research hypothesis~        1. Ketorolac (Acuvail®) will penetrate the anterior chamber and vitreous cavity~          sufficiently to achieve levels above the IC50 for COX-1 and COX-2~        2. Prostaglandin and other inflammatory mediator levels in the anterior chamber and~          vitreous cavity will be significantly higher among diabetic patients than nondiabetic~          controls~        3. Acuvail® can significantly lower anterior chamber and vitreous cavity levels of~          prostaglandins and other inflammatory mediators in diabetic patients~   "
110501|NCT01609868|"~     The investigators hypothesis that premature infants receiving a commercially available~     liquid protein modular will have improved growth when compared with premature infants~     receiving a commercially available powder protein modular.~   "
110504|NCT01609829|"~     The normal, the anticipated difficult and the unanticipated difficult airway are trained in~     the patient safety simulation center (University Hospital Zürich) and the training is being~     observed by video installation.~      Step 1: normal airway (Phantom), technical training~      Step 2: difficult airway (SimMan 3G), technical training~      Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical~     and non-technical (CRM - crew resource management) training.~   "
110505|NCT01609816|"~     This study uses a drug called dasatinib to produce an anti-cancer effect called large~     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as~     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause~     large granular lymphocyte expansion to happen in patients who have received a blood stem~     cell transplant (SCT) between 3 to 15 months after the blood SCT. In this research study,~     researchers want to find how well dasatinib can be tolerated, the best dose to take of~     dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at~     the best dose of dasatinib.~   "
110506|NCT01609803|"~     This research trial studies protein expression in tissue samples from younger patients with~     rhabdomyosarcoma. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~   "
110507|NCT01609790|"~     This partially randomized phase II trial studies the side effects and how well bevacizumab~     given with or without trebananib works in treating patients with brain tumors. Monoclonal~     antibodies, such as bevacizumab, may block tumor growth in different ways by targeting~     certain cells. Trebananib may stop the growth of tumor cells by blocking blood flow to the~     tumor. It is not yet known whether giving bevacizumab together with trebananib is more~     effective than bevacizumab alone in treating brain tumors.~   "
110508|NCT01609777|"~     A handover Tool for doctors and nurses improves the quality of handovers compared to~     handovers that are being conducted without a tool.~      In the present study the investigators will develop and evaluate a handover Tool for doctors~     and nurses. The investigators seek to answer the following research questions:~        1. Does the tool improve quality (i.e. efficiency and accuracy)?~        2. Does the tool improve safety relevant attitude an perceived team collaboration?~   "
110509|NCT01609764|"~     Ageing is associated with a reduction of physical activity, movement efficiency, and quality~     of sleep. This leads to reduced health and well being in elderly subjects. Exercise training~     can increase movement efficiency and quality of sleep.~      Objectives:~        1. Laboratory validation test of body acceleration based indexes for movement efficiency~          and quality of sleep;~        2. Cross-sectional analysis to assess relations between these indexes and age;~        3. Intervention study to assess the effect of exercise training on daily life movement~          efficiency and quality of sleep in ageing subjects~      45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or~     intervention group. Subjects that will have practiced fitness activities in the previous~     year, as well as pregnant or lactating women, will be excluded.~   "
110510|NCT01609751|"~     There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form~     of Yakult fermented milk supports a healthy balanced population of friendly gut bacteria.~     This, coupled with evidence from four European trials showing probiotic benefit for~     recurrent diverticulitis and an understanding of how the disease develops, indicates that~     LcS may also be beneficial. The investigators plan to undertake a pilot study investigating~     whether consumption of once daily probiotic LcS as Yakult fermented milk would help either~     prevent attacks of diverticulitis completely or significantly reduce frequency of attacks.~     Subjects will be recruited from Surrey primary care units and will be closely monitored for~     12 months whilst being supplied with a daily dose of for the full 12 months to see if this~     improves gut health.~   "
110511|NCT01609738|"~     Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right~     ventricular apex (RVA) has become the most frequently used ventricular pacing site. However,~     RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV~     dysfunction and development of heart failure. Recent studies in animals have demonstrated~     that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA~     pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing.~     In addition it was shown that a LV septum lead can be placed permanently by driving a lead~     with extended helix from the RV side through the inter-ventricular septum into the LV~     endocardial layer. This was shown to be a feasible and safe procedure and lead stability was~     shown during four months of follow-up in otherwise healthy and active canines. LV septum~     pacing may therefore be a good treatment alternative in patients with symptomatic~     bradycardia, as well as patients with an indication for cardiac resynchronization therapy~     (CRT). The purpose of this study is to translate the findings from preclinical studies to~     the clinical situation by investigating the feasibility, long-term lead stability and safety~     of LV septum pacing by transvenous approach through the inter-ventricular septum in~     patients.~   "
110512|NCT01609725|"~     Gingival inflammation has been associated with cardiovascular diseases, including heart~     attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose~     and C reactive protein. The treatment of gingival diseases decreases the concentration of~     these risk factors in the blood of cardiovascular patients.~   "
110513|NCT01609712|"~     Patients with vertebral fractures often have problems to straighten and as a consequence of~     impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to~     the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer~     expansion of the lung. Pain is also caused by respiratory excursions of the chest which~     hinder the patients to use their entire lung volume.~      Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing~     stability to the fracture.~      In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.~   "
110551|NCT01609218|"~     The study will evaluate effect of activated charcoal on absorption of LY2140023. The study~     involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth two times~     during study (once with activated charcoal, once without activated charcoal). This study~     will last approximately 16 days not including screening. Screening is required within 30~     days prior to study entry.~   "
110514|NCT01609699|"~     The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical~     motion within fat tissues and cells for the purpose of producing mechanical cellular~     membrane disruption. It is intended for reduction in body circumference.~      The primary objective of this study is to evaluate the efficacy of the Contour I - Y System~     on abdominal circumference reduction relative to baseline pretreatment values using~     different treatment methods.~      The primary efficacy endpoint in this trial is Statistical Difference of Circumference~     reduction between Baseline measurement and at follow-up measurement.~   "
110515|NCT01609686|"~     Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of~     patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that~     reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in~     patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may~     lead to higher blood concentration of TXA when compared to the patients with normal renal~     function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA~     levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass~     aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient~     groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg,~     16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and~     bleeding risk.~      Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood~     concentration of TXA in patients with renal dysfunction when compared to patients with~     normal renal function.~   "
110516|NCT01609673|"~     In the present study, the investigators propose a conversion scheme with 50% reduction in~     CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of~     6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection~     episodes.~      The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic®~     and Certican® significantly improves renal function compared with the standard regimen of~     CNI.~   "
110517|NCT01609660|"~     The purpose of this study is to assess the impact of probiotic administration (Saccharomyces~     boulardii) on patients undergoing colorectal resections comparing to the routine protocol by~     assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the~     mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as~     length of hospital stay~   "
110518|NCT01609647|"~     High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing~     percutaneous coronary intervention (PCI) is related to high risk of short and long term~     recurrent ischemic events including stent thrombosis.~      The investigators hypothesize that additional loading of prasugrel in patients with high PRU~     after clopidogrel loading would be superior to additional loading of clopidogrel in reducing~     platelet reactivity and thereby result in lower risk of short term recurrent ischemic~     events.~   "
110519|NCT01609634|"~     This study is initiated to investigate the effect of a new infant formula in healthy term~     subjects on growth, body composition, tolerance and safety.~   "
110520|NCT01609621|"~     The objective of this prospective, non-randomized, multicenter, post-market, observational~     study is to compile clinical data on percutaneous techniques used to obtain tibiopedal~     access and to cross infrainguinal arterial occlusions.~   "
110521|NCT01609608|"~     1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced~          via a non-invasive oscillation platform could improve symptoms and health-related~          quality of life (HRQOL) in patients with chronic functional constipation.~        2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital~          in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III~          diagnostic criteria were included and randomized to either the WBV treatment or no~          treatment (control) group. The treatment group received six 15-minute sessions of WBV~          therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a~          frequency of 12 Hz. The primary outcome was assessed by the constipation severity~          instrument (CSI). The secondary outcome was improvements in HRQOL.~   "
110522|NCT01609595|"~     Beta thalassemia intermedia is an inherited blood disease caused by molecular mutations~     which reduce the beta globin protein chain of adult hemoglobin A, the protein in red blood~     cells which carries oxygen throughout the body. Beta thalassemias cause progressively severe~     anemia, widespread organ damage, and often require blood transfusions. There is no FDA~     approved therapeutic to treat the underlying cause of beta thalassemia. Fetal hemoglobin is~     another type of endogenous hemoglobin which can replace the reduced beta globin protein,~     reduce the anemia, and even abolish transfusion requirements. This type of hemoglobin is~     normally suppressed in infancy.~      Sodium 2,2 dimethylbutyrate (ST20, or HQK-1001) is a small molecule which stimulates~     production of fetal hemoglobin in nonhuman primates and in human patients in Phase I/II~     trials.~      This is a Phase 2 open-label trial to evaluate the ability of this oral therapeutic to~     reduce anemia in patients with beta thalassemia intermedia, when administered once daily for~     26 weeks. All participants will receive the study drug.~   "
110523|NCT01609582|"~     The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite~     events exists following long term treatment with TAK-875 compared with placebo.~   "
110524|NCT01609569|"~     The aim of this study is to determine on preliminary basis weather an elevated~     pro-calcitonin level can be used to assess ischemia as a result of coronary artery~     complications during percutaneous coronary intervention (PCI).~   "
110525|NCT01609556|"~     The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.~   "
110526|NCT01609543|"~     This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of~     Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced~     or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR)~     activating mutations. Patients will receive Tarceva 150 mg orally daily until disease~     progression or unacceptable toxicity occurs.~   "
110552|NCT01609205|"~     The purpose is to study the relationship between RA disease activity based on Doppler~     quantification and the subsequent clinical response (EULAR response) to treatment with~     Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with~     conventional clinical methods and semiquantitative Doppler assessment.~   "
110527|NCT01609530|"~     Verruca vulgaris (VV), or the common wart, is a relatively prevalent and often frustrating~     cutaneous disease to treat. A single, highly effective therapy for the treatment of VV has~     not been found. Liquid nitrogen is considered the standard of care for VV and studies report~     a 44% to 47% cure rate. In search of more efficacious and convenient therapeutic options, a~     variety of lasers have been reported in the treatment of VV including the Nd:YAG laser~     (1064nm). Lasers offer the potential for decreased treatment associated pain, fewer office~     visits, higher cure rates and lower recurrence rates. However, many of the available~     published studies draw conclusions from case reports and small case series without any~     randomized controlled trials. A randomized, controlled study is needed to evaluate the~     efficacy of the microsecond Nd:YAG (1064nm) compared to conventional cryotherapy.~      This study will use the Cutera CoolGlide Nd:YAG laser that operates in the infrared spectrum~     at a wavelength of 1064nm. This a single site, double blind, randomized controlled clinical~     trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca~     vulgaris of the hands and feet versus conventional liquid nitrogen therapy.~      The investigators hypothesize that there will be a significantly higher number of warts with~     complete resolution at 4 months follow-up in the Nd:YAG treated group versus the liquid~     nitrogen therapy group. The investigators also hypothesize that there will be a faster time~     to complete resolution of the verruca in the Nd:YAG treated group versus the liquid nitrogen~     treated group.~   "
110528|NCT01609517|"~     In these prospective observational study, the investigators are trying to evaluate (1) the~     influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal~     anesthetic outcome by logistic regression analysis.~   "
110529|NCT01609504|"~     The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL~     LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC~     TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal~     cancer after Neoadjuvant Treatment.~   "
110530|NCT01609491|"~     In ophthalmic surgery the specific anaesthesiological challenges necessitate the~     administration of a combination of relatively high doses of hypnotics and analgetics. In~     order to preserve adequate organ perfusion, there is often a need to administer~     pharmacological agents for haemodynamic support. Depending on the experience of the~     anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is~     currently not known which of these agents has the most favorable haemodynamical profile.~      Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and~     systemic resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be~     monitored noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring~     devices.~   "
110531|NCT01609478|"~     To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with~     persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.~   "
110532|NCT01609465|"~     There is currently no published algorithm for secondary prevention prognosis of CHD that is~     representative of the England GP-registered population and that includes both symptomatic~     and asymptomatic patients (as identified through primary care). In this paper the~     investigators will exploit routinely collected information in clinical practice to model CHD~     prognosis based on a large contemporary open cohort of stable CAD patients. Although the~     investigators model is based on data from GP practices in England only, the investigators~     believe that this population is sufficiently heterogeneous in terms of ethnic mix,~     socioeconomic background, predisposing characteristics and lifestyles to generate a~     prognostic model with good generalizing power to the wider population.~      Among the research questions the investigators will try to answer is whether established~     risk factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes)~     are also reliable for risk-stratification of patients who have already developed CAD.~     Similarly, the investigators will examine whether strong predictors of adverse outcomes in~     ACS patients in the short term, such as admission SBP and heart rate, are also associated~     with their long term prognosis.~   "
110533|NCT01609452|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod~     when administered on top of standard-of-care to subjects with Immune Thrombocytopenic~     Purpura (ITP).~   "
110534|NCT01609439|"~     The purpose of this study is to determine if pre-operative vitamin D supplementation lowers~     the incidence of post-operative transient or permanent hypoparathyroidism in patients~     undergoing total thyroidectomy.~   "
110535|NCT01609426|"~     The primary purpose of the study is to identify the factors of steroid dependency in~     childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of~     nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after~     the first manifestation. Different clinical and biological factors will be analyzed: age of~     first manifestation, delay of remission, ethnicity, and preceding viral infection,~     geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in~     the genes involved in the response to steroid therapy.~   "
110536|NCT01609413|"~     In a crossover, single blind, randomized trial the calcium bioavailability of two calcium~     supplements will be compared.That is AlgaeCal®(Algaecal Inc, Vancouver, Canada)(1 dose is 3~     capsules of 180 mg calcium), derived from ocean algae and the proprietary calcium supplement~     Caltrate 600® (Wyeth Consumer Healthcare, Inc).~      After a screening visits 20 healthy male subjects aged 20-50 years will spend a day at the~     research center to examine calcium bioavailability data. They will be randomized to consume~     either first the AlgaeCal® supplement or the Caltrate 600® supplement. After a one week~     wash-out period subjects will be supplemented with the other supplement. During the~     examination day blood and urine samples will be collected before and until eight hours after~     the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy~     vitamin D. Subjects are instructed to avoid taking calcium and/or vitamin D supplements 1~     week before and during the entire study period. In addition, they are not allowed to take~     medication that may affect calcium metabolism.~      The hypothesis of the study is that calcium bioavailability of the AlgaeCal® supplement will~     be higher than that of the Caltrate 600® supplement.~   "
110537|NCT01609400|"~     The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term~     safety and evaluation if a satisfactory breast cancer screening can be performed in subjects~     treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also~     performed.~   "
110538|NCT01609387|"~     This study is a double blind randomized controlled trial.~   "
110539|NCT01609374|"~     This is a prospective, concurrently controlled, multi-center study to evaluate the safety~     and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior~     cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical~     radiculopathy with or without cord compression. Some participating sites will enroll just~     M6-C patients, while others will enroll just ACDF patients.~      Patients eligible for study enrollment will present with degenerative cervical radiculopathy~     requiring surgical intervention, confirmed clinically and radiographically, at one vertebral~     level from C3 to C7.~      A total of 243 subjects will be included at up to 20 sites.~   "
110540|NCT01609361|"~     Rehabilitation program improves operative results following conventional open colorectal~     surgery. Very few data are available on such program in laparoscopic colorectal surgery.~   "
110541|NCT01609348|"~     This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease.~     Venlafaxine works by increasing natural substances in the brain (serotonin and~     norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest~     neurodegenerative disease of aging and the cause of major financial and emotional burden to~     patients, families and caregivers, and society. Depression is a very common symptom of AD,~     affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's~     disease) contributes greatly to patient disability and caregiver distress. Neither~     psychosocial interventions nor psychotropic medications have proven effective to date for~     the treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug~     Administration (FDA) for the treatment of major depression but it is not known whether or~     not it can help depression in Alzheimer's Disease.~   "
110542|NCT01609335|"~     Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated~     diagnostic criteria for AD where their role is to identify the pathophysiological processes~     underlying cognitive impairment or to predict time to dementia. Three of these biomarkers~     are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In~     order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous~     values much be divided into normal and abnormal ranges. This requires that a cut point(s) be~     established in the continuous distribution of values for each biomarker.~      The investigators objective in this proposal is to obtain imaging biomarker data in a group~     of individuals who are appropriate for establishing normative values for AD biomarkers. The~     investigators believe the most valid approach to establishing biomarker cut points is to~     base them on the upper bound of the range observed in young to early-middle-age subjects in~     whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of~     community-based autopsy data, that upper age limit would be about 50 years old. The lower~     age bound for a group of subjects used to establish normative AD biomarker values would have~     to be based on considerations of brain maturation, which may continue into the middle- to~     late-20s. Thus, taking the above into consideration, the ideal age range for establishing~     normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages~     30-49 years old.~   "
110543|NCT01609322|"~     This project aims to test the efficacy of an in-home intervention, Activity, Balance,~     Learning, and Exposure (ABLE), which integrates exposure therapy with cognitive~     restructuring, exercise, and home safety evaluation for older adults with excessive fear of~     falling. The intervention will be conducted by a licensed physical therapist. A control~     intervention will be conducted by a health educator. The specific aims of the study are to~     test the feasibility, acceptability, tolerability, and safety of the ABLE intervention.~   "
110544|NCT01609309|"~     -  Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally~          invasive surgery has gained popularity for the treatment of early gastric cancer in~          East Asian countries, even though the long-term follow-up outcome based on multicenter~          randomized clinical trial (RCT) is still awaited.~        -  For the patient with locally advanced gastric cancer, several studies indicated that~          laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically~          feasible and safe procedure by experienced surgeons in high-volume specialized~          hospitals. However, the application of it is controversial mainly due to lack of solid~          evidence on the oncologic efficacy. Therefore, conventional open approach is still the~          current standard for advanced gastric cancer.~        -  Nowadays, the proportion of patients with locally advanced gastric cancer is estimated~          up to 80 per cent of all gastric cancer cases in China. Before the clinical application~          of laparoscopic procedure for the treatment with curative intent to advanced gastric~          cancer located at the middle- or lower-third of the stomach, the oncologic efficacy~          must be verified.~        -  Accordingly,the comparison of intraoperative and postoperative complications between~          laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with~          gastric cancer based on a randomized controlled trial is needed.~   "
110545|NCT01609296|"~     The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™~     Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial~     femoral and/or popliteal arteries in a real world patient population.~   "
110546|NCT01609283|"~     The purpose of this study is to determine determine the safety of intraspinal delivery of~     mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic~     Lateral Sclerosis (ALS) using a dose-escalation study.~   "
110547|NCT01609270|"~     Post-marketing surveillance registry of the CardioRoot graft.~   "
110548|NCT01609257|"~     The purpose of this study is to determine whether the norovirus vaccine is effective in~     preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge~     dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of~     the vaccine.~   "
110549|NCT01609244|"~     Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients~     with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.~   "
110550|NCT01609231|"~     The purpose of this adaptive trial is to compare the progression-free survival of~     participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan~     therapy relative to participants treated with cetuximab + irinotecan.~   "
110587|NCT01608750|"~     The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI)~     treatment in patients with functional dyspepsia.~   "
110982|NCT01603576|"~     This study will be an initial proof of concept study, to evaluate safety and efficacy of a~     prototype suprachoroidal retinal implant~   "
110553|NCT01609192|"~     The project's background: Sickle cell disease is, at present in France, the most frequent~     genetic illness. Recent progress in its treatment, in particular the use of hydroxyurea, has~     considerably modified the prognosis of this disease. Many more patients now reach~     reproductive age and do consider fathering. Exceptional studies have reported the potential~     impact of this medical treatment on the sperm parameters and fertility of male patients. In~     a retrospective analysis, the investigators found that the observed alterations of semen~     parameters due to sickle cell disease seem to be exacerbated by hydroxyurea treatment.~      The study hypothesis: A large prospective study is essential to assess the potential adverse~     impact of the medical treatment of sickle cell disease on spermatogenesis and consider the~     advisability of proposing sperm cryopreservation before this treatment is started.~      Primary purpose of the protocol: evaluate the impact of a treatment by hydroxyurea (20-30~     mg/kg/day), 6 months after its beginning, in 34 men with sickle cell disease (18-60 years~     old). The main trial criterion will be the average difference of the concentration of~     spermatozoa s (millions/ml) in the ejaculate, before and after 6 months of medical~     treatment.~   "
110554|NCT01609179|"~     A treatment protocol that enables patients to have continued access to IPI-926.~   "
110555|NCT01609166|"~     Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective~     preventative treatment has been definitively demonstrated. This trial is conducted on the~     basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.~      A randomized, double-blind phase III trial will evaluate 40 patients receiving their first~     ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days.~     Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be~     applied to the hands and feet twice per day for 6 months after the start of capecitabine.~     Patients will be examined every month and the investigators will take some photographs of~     hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events~     [CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary~     end point is the incidence of moderate/severe HFS symptoms at the end of capecitabine~     treatment , based on the patient-reported dermatological exploration.~   "
110556|NCT01609153|"~     A study to examine whether an antipsychotic combination treatment of olanzapine and~     amisulpride is more effective than olanzapine and amisulpride alone.~   "
110557|NCT01609140|"~     The purpose of this study is to evaluate the safety and cholesterol lowering effects of~     MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with~     a high risk of cardiovascular events and LDL-c levels well above goal.~   "
110558|NCT01609127|"~     This study is being conducted to compare the efficacy and safety of tesetaxel administered~     once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive~     weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days~     in a 21-day cycle.~   "
110559|NCT01609114|"~     The concurrent use of chemotherapy during radiation therapy (CCRT) is now the important~     treatment stratagem for locally advanced head and neck cancer or nasopharyngeal cancer~     (NPC). For these cases, 5-Fluorouracil (5-FU) and cisplatin (CDDP) are the most commonly~     used agents of CCRT. It plays an important role to improve the treatment outcome and~     increases the opportunities for organ preservation.~      In the past, Radiotherapy (RT) was solely used as a local treatment and its effect was~     estimated by local effect model. However, growing evidence shows that irradiation has direct~     DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, the~     investigators reported that abdominal irradiation could significantly modulate the systemic~     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the~     daily treatment dose for target treatment in an experimental rat model. Additionally, the~     results from a clinical investigation showed that colorectal cancer patients with lower AUC~     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these~     lines of evidence support the importance and necessity to search for the mediators~     responsible for the unexpected effect of local RT on systemic pharmacokinetics of~     chemotherapeutic agents, such as 5-FU.~      In the present study, the investigators examined whether the phenomena and mechanism of~     RT-PK(pharmacokinetics) is a fact for different anticancer drugs and for different part in~     human.~   "
110560|NCT01609101|"~     In this randomised crossover trial we measure the space between the right side of the~     laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients~     with a normal mouth opening. We compare the remaining spaces for seven different~     videolaryngoscopes and compare these to a classic Macintosh laryngoscope.~   "
110561|NCT01609088|"~     The study will determine whether acute and chronic consumption of a beverage containing~     erythritol will improve endothelial function in patients with type 2 diabetes mellitus.~   "
110562|NCT01609075|"~     This observational, multicenter, retrospective/prospective study will evaluate the use of~     Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer.~     Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy~     and Avastin will be followed for up to 15 months.~   "
110563|NCT01609062|"~     The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0~     mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks. Secondary~     objectives were to investigate the effect of the two doses on exercise capacity for up to~     196 weeks. In addition, the pharmacokinetic (PK) parameters of both doses of BMN 110 was~     assessed.~   "
110564|NCT01609049|"~     This prospective observational study will evaluate the efficacy and safety of Pegasys~     (peginterferon alfa-2a) in combination with ribavirin in patients with chronic hepatitis C,~     including patients with compensated liver cirrhosis, in clinical practice. Data will be~     collected from patients receiving Pegasys and ribavirin during up to 72 weeks of treatment~     (according to registered indications depending on baseline viral load, genotype and~     virological response) and a 24-week follow-up.~   "
110565|NCT01609036|"~     This observational study will evaluate the safety and efficacy of MabThera/Rituxan~     (rituximab) in previously untreated patients with follicular lymphoma. Data will be~     collected for 3 years~   "
110566|NCT01609023|"~     This observational study will evaluate the safety and efficacy of MabThera/Rituxan~     (rituximab) in combination with chemotherapy in 1st and 2nd line treatment of patients with~     CD20-positive C-cell chronic lymphocytic leukaemia. Data will be collected from eligible~     patients receiving MabThera/Rituxan according to the Summary of Product Characteristics~     during 6 months of treatment.~   "
110567|NCT01609010|"~     This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan~     (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with~     follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either~     MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day~     subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375~     mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle~     of treatment. The anticipated time on study treatment is up to 6 months.~   "
110568|NCT01608997|"~     Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical~     activity. When symptomatic, the injury affects all aspects of general health, quality of~     life and function. Surgical intervention is recommended only if conservative treatment~     fails. The purpose of the surgical intervention is to reduce pain, and improve function~     while improving range of motion and muscle strength around the shoulder. The purpose of the~     current study is to measure physical, functional, expectation, satisfaction and quality of~     life outcomes after rotator cuff repair surgery. Another purpose is to learn the~     reproducibility components of the above outcomes.~   "
110569|NCT01608984|"~     Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces~     myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with~     cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular~     mechanisms leading to these effects are yet not fully understood. The purpose of the present~     study is to validate previous studies and gather further evidence for RIPC during CABG with~     blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during~     Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular~     mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.~   "
110570|NCT01608971|"~     Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of~     heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies~     suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding~     complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a~     protamine regimen based on the initial heparin dose before CPB might lead to overdose of~     protamine. In contrast, a protamine regimen based on the actual heparin concentration may~     avoid this condition. The investigators compare both regimens of protamine dosing in~     patients undergoing complex surgery with CPB and assess its effect on the amount of~     protamine given, markers of the coagulation system, utilization of blood products and~     perioperative blood loss.~   "
110571|NCT01608958|"~     The study will evaluate whether prophylactic oxytocin administered in the third stage of~     labor via IV infusion results in a lower mean blood loss compared to IM injection.~   "
110572|NCT01608945|"~     The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with~     impairment of liver function. Perioperative steroid administration has been advocated to~     reduce liver damage. The aim of this prospective, randomized study was to determine whether~     steroid administration can reduce liver injury and impact the prognosis~   "
110573|NCT01608932|"~     The purpose of this study is to evaluate whether telemonitoring of frail patients with~     chronic diseases produces benefits in terms of reduced readmissions, improved health related~     quality of life, and improved health status. In addition, the trial evaluates the economic~     and organisational impact of the telemonitoring service and examines its acceptability by~     patients and health professionals.~   "
110574|NCT01608919|"~     This study plans to learn more about the role of 2 blood tests in predicting who might~     develop a blood clot in their arm or leg after major surgery. The investigators know that~     patients who have cancer and major surgery have a higher than normal risk of getting blood~     clots in the veins of their arms or legs. This can be very dangerous because the clot can~     move into your lungs.~   "
110575|NCT01608906|"~     This study plans to learn more about what is the best treatment to prevent blood clots in~     patients in intensive care units (ICU's). The investigators know that patients who are in~     ICU's have a higher than normal risk of getting blood clots in the veins of their arms or~     legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the~     standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000~     units at each dose). In this study the investigators are randomizing patients to receive~     either standard of care or low dose intravenous heparin in a continuous infusion.~   "
110576|NCT01608893|"~     Atrial fibrillation (AF) is the most common sustained heart rhythm disorder and is~     associated with significant symptoms and health problems including an increased risk of~     stroke and death. Current drug therapies are often ineffective and associated with~     significant side effects. Abnormalities of calcium regulation in cells may lead to triggers~     for AF. Emerging data suggest that abnormal intracellular calcium regulation mediated~     through the ryanodine receptor in heart cells may contribute to AF. Recently the~     investigators have shown that the β-blocker carvedilol which is most commonly used to treat~     patients with heart failure, modifies calcium regulation mediated through the ryanodine~     receptor. At present this drug is not frequently used to treat AF. Therefore the~     investigators will conduct a randomized trial comparing carvedilol to metoprolol for~     prevention of paroxysmal AF. This may result in improved health and quality of life for~     people who suffer AF.~   "
110577|NCT01608880|"~     Background:~      Mastectomy flap necrosis (MFN) is a common complication that affects recovery,~     reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent~     topical vasodilator that increases local blood flow by dilating arteries and veins without~     altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate~     whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM)~     or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of~     mastectomy flap necrosis.~      Objective:~      To evaluate if the post-operative application of NTG ointment improve rates of MFN in~     patients undergoing SSM or NSM with immediate breast reconstruction compared to patients~     receiving placebo.~      Hypothesis:~      In patients undergoing SSM and immediate breast reconstruction there will be a decrease in~     the rate of MFN in those who receive NTG ointment compared to those who receive placebo.~   "
112134|NCT01588522|"~     This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the~     overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with~     metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.~   "
110578|NCT01608867|"~     This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid~     tumor for which there is no remaining standard curative therapy. Subjects will be assessed~     for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim~     analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will~     receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days~     following the discontinuation of OMP-54F28.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects~     will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose~     escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e.,~     doses between the dose levels listed above) may also be tested upon agreement with the~     investigators and the study sponsor. In addition, alternate dosing schedule cohorts of~     OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the~     investigators and the study sponsor. These alternative less frequent dosing schedules may be~     evaluated if emerging data suggest that once every 3 week dosing results in tolerability~     concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The~     dose may be administered at any time during the day. Three subjects will be treated at each~     dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects~     experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects~     experience a DLT, no further subjects will be dosed at that level and 3 additional subjects~     will be added to the preceding dose cohort unless 6 subjects have already been treated at~     that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for~     newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have~     completed their Day 28 DLT assessment. Subjects who have a >2-fold increase of their fasting~     β-CTX or a decline of >3% in their bone mineral density (BMD) from screening or a T-score~     decline to <-2.5 in the total femur or L1-L4 DEXA scan measurement will be started on~     zoledronic acid. Subjects with stable disease or a response at Day 56 will be allowed to~     continue to receive OMP-54F28 until disease progression. An additional 6 subjects will be~     enrolled in an expansion cohort at the highest dose level that results in <2 of the 6~     subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in~     24 hours) or Grade 4 adverse event (DLT). Tumors of particular interest for inclusion in the~     expansion cohort include sarcomas, basal cell carcinoma, ovarian cancer, desmoid tumors and~     prostate cancer given the known importance of the Wnt pathway in these malignancies.~   "
110579|NCT01608854|"~     In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup~     around the spinal cord. The purpose of this study is to determine whether postoperative~     antibiotic treatment continued for the duration of time a drain is in place results in a~     lower infection rate than antibiotics given for only 24 hours postoperatively.~   "
110580|NCT01608841|"~     The purpose of this study is to investigate the influence of epidermal growth factor~     receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic~     cancer.~   "
110581|NCT01608828|"~     Studies suggest that strabismus has a negative impact on a person's self-image,~     interpersonal relationships, emotional and psychosocial state (4-15). There are, however,~     few such studies based in Asia, and the functional and psycho-social impact of disease is~     often neglected in our management of strabismus in Singapore. The aim of this pilot study is~     to measure quality-of-life (QOL) among strabismic children in Singapore so as to better~     understand the functional and psychosocial issues faced by these children in their daily~     living. The investigators also hope to evaluate the performance of the Intermittent~     Exotropia Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire~     (AS-20) (1) and to determine if differences between child and parental perceptions exist.~      60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be~     invited to participate in the study and answer questions in 2 Pediatric Eye Disease~     Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children~     aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16~     years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20~     questionnaires. Their parents will answer the self-administered IXTQ child-proxy (12~     questions), IXTQ parental (17 questions) and modified AS20 child-proxy questionnaires (20~     questions). For comparison, 60 aged-matched children without strabismus or amblyopia (30~     aged 5-7 years, and 30 aged 8-16) and their parents will also be invited to answer similar~     questionnaires (controls).~      Results will be analysed question-by-question and then by composite score, and comparison~     will be made between child and parental-proxy measures, as well as with scores obtained from~     myopic children. It is hoped, that from this study, we will be able to assess the usefulness~     of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess~     the feasibility of its use in a larger study looking at the impact of strabismus and its~     treatment in Singaporean children.~   "
110582|NCT01608815|"~     This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide~     vaccine in Japanese participants to support registration of the product in Japan.~      Primary Objective:~      To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase~     of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination~     with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.~      Secondary Objectives:~        -  To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up~          to 28 days after vaccination, in subjects aged 2 years and above.~        -  To describe the immune response following a single dose of typhoid Vi polysaccharide~          vaccine in subjects aged 2 years and above.~   "
110583|NCT01608802|"~     Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a~     systematic appraisal of the literature found almost no outcome or evaluative evidence.~      Aim:~      The investigators aim to evaluate the efficacy of HIV palliative care training and a simple~     palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy~     (ART), and to evaluate this in terms of patient outcomes under clinical experimental~     conditions in 2 African countries using randomised controlled trial (RCT) designs.~      Intervention being tested:~      Within each well-established HIV ART clinic, patients will be randomly allocated to either~     continue receiving standard care (control group) or to receive standard care plus~     appointments with a clinic nurse trained in basic palliative care (intervention group).~      Methods:~      Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be~     powered and conducted in parallel to a common research design protocol, thus permitting~     evidence of outcomes that reflects 2 different ART providers, providing evidence of~     palliative care efficacy relevant to different HIV care settings.~      Primary outcome: Each trial has been powered to a primary endpoint of pain control.~      Secondary outcomes: The secondary outcomes are the core domains of palliative care as~     defined by the WHO (i.e. physical, including symptoms, psychological, social and spiritual)~     and measured by the APCA African POS. Further secondary outcomes measured will be: adherence~     to treatment; risk behaviours; health-related quality of life; psychological morbidity.~      Inclusion: Patients will be screened and invited into the trial if they are on ART, score~     3-5 on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give~     informed consent to trial entry and data collection.~      Analysis: An intention-to-treat analysis will be conducted to determine treatment response~     differences between the two conditions. In order to maximise the efficiency of longitudinal~     data, multi-level modelling will be applied as appropriate.~   "
110584|NCT01608789|"~     This study is a prospective, single arm, non-randomized, multi-center clinical study that~     will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue®~     Male Sling in post-prostatectomy urinary incontinence.~   "
110585|NCT01608776|"~     To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of~     Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers~     (DFU).~   "
110586|NCT01608763|"~     The major objective of this project is to conduct a randomized controlled trial comparing~     the impact of the normative feedback and other personalized feedback components of the Check~     Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem~     drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design~     - to receive just the normative feedback component of the CYD intervention, just the other~     personalized feedback information, to a no intervention control condition, or to receive the~     full CYD intervention. The no intervention control condition will not be sent any~     intervention materials but will instead be sent a list of the different components of the~     CYD feedback and will be asked to think about how useful they would find each of them. All~     participants will be followed-up at 3 months.~   "
110588|NCT01608737|"~     The objectives of this study are:~        1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335~          (high dose given for 12 weeks or low dose given for 24 weeks both in combination with~          Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in~          treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.~        2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in~          combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in~          chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV~          treatment.~   "
110589|NCT01608724|"~     The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with~     type 2 diabetes mellitus.~   "
110590|NCT01608711|"~     The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4~     administered in combination with gemcitabine in subjects previously treated in protocol~     2008002.~   "
110591|NCT01608698|"~     The purpose of this study is to evaluate different side effect in contraceptive use of two~     oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg~     chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®),~     especially body weight change.~   "
110592|NCT01608685|"~     Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for~     the detection of tuberculosis (latent or active infection) than the tuberculin skin test~     (TST) in immunocompetent individuals. However, very little data are available concerning the~     relative performance of IGRA and TST in immunosuppressed individuals from other causes than~     HIV.~      The investigators hypothesize that IGRAs would be more sensitive and specific than the TST~     in a group of renal transplant recipients under chronic immunosuppressive treatment for~     detecting latent tuberculosis infection.~   "
110593|NCT01608672|"~     This is an observational study assessing patient satisfaction following at least 5 years of~     BOTOX® treatment for glabellar lines.~   "
110594|NCT01608659|"~     This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type~     A for the treatment of facial lines.~   "
110595|NCT01608646|"~     In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin~     chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.~   "
110596|NCT01608633|"~     Pain after dry needling or injection in the muscle is a frequent secondary effect in the~     treatment of myofascial pain syndrome. In this trial spray and stretch technique is~     evaluated as a method to reduce this soreness. As well, the characteristics and the~     different factors that influence in this pain will be described.~   "
110597|NCT01608620|"~     Since uncontrolled observational studies first linked fructose to the epidemic of obesity~     almost a decade ago, it has become a focus of intense concern regarding its role in the~     obesity epidemic and increasing burden of cardiometabolic disease. Despite the uncertainties~     in the evidence, international health organizations have cautioned against moderate to high~     intakes fructose-containing sugars, especially those from sugar sweetened beverages (SSBs).~     To improve the evidence on which nutrition recommendations are based, the investigators~     propose to study of the role of fructose-containing sugars in the development of~     overweight/obesity, diabetes, hypertension, gout, and cardiovascular disease, by undertaking~     a series of systematic syntheses of the available prospective cohort studies. Prospective~     cohort studies have the advantage of relating real world intakes of sugars to clinically~     meaningful disease endpoints over long durations of follow-up. The findings generated by~     this proposed knowledge synthesis will help improve the health of consumers through~     informing recommendations for the general public, as well as those at risk of diabetes and~     cardiovascular disease.~   "
110598|NCT01608607|"~     Since uncontrolled observational studies first linked fructose to the epidemic of obesity~     almost a decade ago, it has become a focus of intense concern regarding its role in the~     obesity epidemic. Despite the uncertainties in the evidence,the recommendations of~     international health organizations have cautioned against moderate to high intakes~     fructose-containing sugars, especially those from sugar sweetened beverages (SSBs). To~     improve the evidence on which nutrition recommendations are based, the investigators propose~     to study of the effect of fructose-containing sugar sweetened beverages (SSBs)on body~     weight, by undertaking a systematic synthesis of the data taken from all available clinical~     studies in humans. This technique has the strength of allowing all of the available data to~     be pooled together and differences to be explored in groups of different study participants~     (healthy humans of different sex, weight, and age and in those with diseases which~     predispose to disturbances in metabolism, such as diabetes) with dietary fructose in~     different forms, doses, and with differing durations of exposure. The findings generated by~     this proposed knowledge synthesis will help improve the health of consumers through~     informing recommendations for the general public, as well as those at risk of diabetes and~     cardiovascular disease.~   "
110599|NCT01608594|"~     The purpose of this study is to evaluate the safety and potential effectiveness of a new~     treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and~     IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better~     understand this disease, how best to treat it and what patients should be treated with this~     combination.~   "
110600|NCT01608581|"~     The aim of this study was to evaluate the effectiveness of a targeted burn prevention~     message on burn safety knowledge and behavior.~   "
110613|NCT01608412|"~     The study hypotheses to be tested in this study are:~        -  Conversion to everolimus at 3 months post-transplantation is safe and effective;~        -  Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months~          pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection,~          tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant~          recipients;~        -  Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis)~          can be replaced with accurate noninvasive molecular diagnostic tests in kidney~          transplant recipients.~   "
110614|NCT01608399|"~     The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for~     major depressive disorder. Additional aims are to (2) investigate patterns of change and the~     mechanisms of action involved during treatment, and to (3) examine the impact of~     meta-cognitions in the treatment and relapse prevention of depression.~   "
110601|NCT01608568|"~     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh~     attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique~     using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech~     Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed~     delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic~     failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed~     absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The~     investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.~      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with~     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,~     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique~     using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1~     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) will be less costly than the standard fixation interrupted technique using 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.~      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique~     based on subjective surgeon satisfaction questionnaires.~   "
110602|NCT01608555|"~     The study will include 10 adult patients with cystic fibrosis. The aim of the study is to~     evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial~     load in the airways. Secondary end-point is the evaluation of variation in bacterial~     susceptibility during and at the end of study period.~   "
110603|NCT01608542|"~     This is a single and multiple dose study in healthy male and female (of non-child bearing~     potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib.~     Fostamatinib is being developed for the treatment of rheumatoid arthritis.~   "
110604|NCT01608529|"~     It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with~     the aim of increase nasal airflow resistance, therefore the objective was to examine the~     effects of FeelBreathe with lung ventilation and gas exchange during exercise.~   "
110605|NCT01608516|"~     The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection~     of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT,~     MRI and US and to determine the contribution of each imaging technique. Current gold~     standard for inflammation is histopathology.~      Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with~     atheromatous plaques in the carotid artery eligible for endarterectomy.~   "
110606|NCT01608503|"~     The subclavian vein (SCV) is a preferred site for placement of central venous catheter.~     However, pneumothorax is a major concern during subclavian venous catheterization. Lung~     deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the~     distance between the pleura and the SCV. The investigators evaluated the effect of lung~     deflation on the relative position between the pleura and the line of the imaginary needle~     pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV)~     using ultrasonography.~   "
110607|NCT01608490|"~     Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of~     the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System~   "
110608|NCT01608477|"~     Over the past decades, survival rates in heart transplantation recipients improved~     significantly, due to advancements in regimens of immunosuppressives and surgical~     techniques, but are still limited to the first 12 months post transplantation. Long-term~     survival remains almost unchanged indicating the need to identify and improve relevant~     factors. Evidence in other chronically-ill patient populations shows that the healthcare~     system (e.g. level of chronic illness management (CIM)) and patient self-management (e.g.~     adherence) drive improvements in outcomes.~      The BRIGHT study is the first multi-centre, multi-continental study examining healthcare~     system and heart transplant centres chronic illness management practice patterns and~     potential correlates of immunosuppressive medication nonadherence.~      The knowledge gained will inform clinicians, researchers and healthcare policy makers about~     the level(s) interventions need to be implemented at to improve long-term outcomes for~     transplant recipients.~   "
110609|NCT01608464|"~     The purpose of this study is to improve their outcome by either changing the chemotherapy~     drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will~     improve their outcome.~   "
110610|NCT01608451|"~     Randomized Controlled Trial of Neoadjuvant Progesterone and Vitamin D3 in women with Large~     Operable Breast Cancer and Locally Advanced Breast Cancer - A Feasibility Study~      Primary Progesterone Timing of surgery during the menstrual cycle and its impact on survival~     in premenopausal women with operable breast cancer has been extensively researched and~     reinvestigated by Badwe et al in the randomized clinical trial of 'Primary Progesterone~     Therapy for Operable Breast Cancer' at Tata Memorial Hospital. The underlying assumption was~     that the presence of unopposed estrogen (in follicular phase) at the time surgery may be~     deleterious for survival and that circulating progesterone might counteract this deleterious~     effect.~      Vitamin D3 The most prominent physiological role of hormonally active form of vitamin D3,~     1,25-dihydroxyvitamin D3 (1,25(OH)2D3 or calcitriol), is regulation of calcium and~     phosphorous homeostasis and bone metabolism via an intracellular receptor (VDR) which is a~     member of steroid thyroid hormone super-family of receptors. The VDR receptors are also~     found in other tissues like breast and prostate.~      Vitamin D compounds have also been implicated in promotion of apoptosis in breast cancer~     cells and evidence suggests that 1,25(OH)2D3 and its synthetic analogues may potentiate~     responsiveness of breast cancer cells to conventional cytotoxic agents.~      Objectives~        1. To see the effect of primary progesterone on survival in women with high risk breast~          cancer (large operable and locally advanced breast cancer)~        2. To see the effect of Vitamin D3 as an antiproliferative, cytotoxic and apoptotic agent~          (negative growth regulator) by evaluation of surrogate markers of proliferation and~          apoptosis.~      Inclusion Criteria:~        -  Unilateral breast cancer~        -  Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast~          cancer/LABC (T3N1-2M0; T2N2M0)~        -  Age <70 years~        -  Fit for CT~      Exclusion Criteria:~        -  Prior Incision Biopsy or Excision Biopsy~        -  Metastatic breast cancer~        -  Renal failure or deranged Renal Function Test~        -  Hypoparathyroidism~        -  Pregnant or lactating mothers or women of childbearing age not practicing contraception~        -  Patient on any of the following drugs: Magnesium-containing antacids, Digitalis,~          Phenytoin barbiturates, Thiazide diuretics.~        -  Previous history of other cancers except cured skin and cervical carcinoma in situ.~      Methodology / Treatment plan~      The study drugs (Injectable Progesterone and Vitamin D3) will be tested in the neoadjuvant~     setting prior to administration of each chemotherapy cycle, in a 2x2 factorial design as~     below:~      Neoadjuvant D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before~     each chemotherapy cycle.~      Neoadjuvant Progesterone used will be administered as single IM depot injection 500mg 5 days~     prior to each CT cycle and surgery date.~      Primary Objectives Disease-free survival~      Secondary Objectives Improvements in overall survival Tumor response~   "
110611|NCT01608438|"~     People with tetraplegia often retain some level of mobility of the upper body. The proposed~     study will test the hypothesis that it is possible to develop personalized interfaces, which~     utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs~     and other assistive devices. If successful the project will result into the establishment of~     a new family of human-machine interfaces based on wearable sensors that adapt their~     functions to their users' abilities.~   "
110612|NCT01608425|"~     Telemedicine technology enables a direct and online text- and image communication in the~     treatment system from patient to the ulcer specialist. The technology is expected to have~     patient-related, economic and therapeutic benefits. The study is a substudy of a larger~     project entitled Renewing Health, where also the economic and management aspects are~     highlighted. However, only few randomized prospective studies are conducted in this field.~     The purpose of the study is in a randomized prospective study, to assess the impact of the~     introduction of the telemedicine technology as consultation form between ulcer-nurses in the~     primary sector and the wound clinics at the hospitals in the region. It is assessed whether~     the technology can be adopted without incurring the patient a risk. The study aims to~     perform an impact analysis of the introduction of new technologies for telemedicine wound~     monitoring in the treatment of diabetic foot ulcers through different studies.~   "
110656|NCT01607853|"~     The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied~     then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20~     minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24~     hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by~     KJ Dumas and JR Scholtz.~   "
110615|NCT01608386|"~     Anterior approach results in better operative and survival outcomes compared with the~     conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior~     approach has the problem of bleeding from the hepatic vein.~      Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce~     blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC~     clamping may also reduce blood loss in anterior approach right hepatic resection. So the~     investigators conduct this prospective, randomized, controlled trial to compare anterior~     approach combined with infrahepatic IVC clamping and anterior approach in major right~     hepatectomy for large HCC.~   "
110616|NCT01608373|"~     This prospective randomized study aims to comparison the effectiveness of intravenous~     lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in~     patients undergoing laparoscopic cholecystectomy.~      A total of 83 patients will be randomized into one of three groups (group C or group I or~     group P) based on Excel number generation.~      Patients in group C will receive normal saline intravenous injection, and patients in group~     I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a~     continuous lidocaine infusion of 2 mg/kg/hr.~      Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg~     lidocaine and normal saline 100cc.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4,~     8, 12, 24, 48 hours postoperatively.~   "
110617|NCT01608360|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous~     lidocaine injection on the relief of pain in patients undergoing thyroidectomy.~      A total 56 patients will be randomized into one of two groups(group C or group I) based on~     Excel number generation.~      Patients in group C will receive normal saline intravenous injection, and patients in group~     I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous~     lidocaine infusion of 2mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients~     pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of~     nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.~   "
110618|NCT01608347|"~     Recurrent miscarriage (RM) is traditionally defined as three or more consecutive~     miscarriages occurring before 20 weeks post-menstruation. It is one of the most common~     clinical problems in reproduction, yet a definite cause can be established in only 50~     percent of cases (ACOG practice bulletin, 2002). Many etiological factors have been proposed~     but none of them has been fully substantiated. RM has been directly associated with maternal~     thrombophilic disorders, parental chromosomal anomalies, and structural uterine anomalies~     and indirectly with maternal immune dysfunction and endocrine abnormalities.~      The association between pregnancy loss and antiphospholipid antibodies (aPL) was first~     noticed in the latter third of the last century. The antiphospholipid syndrome (APS) is~     characterized by the presence of antiphospholipid antibodies (APLA), associated with venous~     and/or arterial thrombosis, and/or pregnancy loss. The adverse pregnancy outcomes associated~     with the presence of APLAs include: recurrent fetal loss, intrauterine growth restriction~     (IUGR), and severe pre-eclampsia especially of early onset.~      Testing the effect of Heparin in treatment of cases with RA but negative for APA has bee~     done in few animal and clinical studies. Animal studies showed that the subset of cases with~     disorders suspicious for APS but who had negative test results for LAC and aCL is carrying~     antibodies pathogenic to murine pregnancy. Testing other immunoglobulin G may provide~     additional means to identify cases with an yet uncharacterized immune condition. Moreover,~     the clinical relevance of low levels of APLA in these women remains unproved.~      Randomized prospective study was done to assess the efficacy of early thromboprophylaxis of~     Low molecular weight heparin (LMWH) (Enoxaparin sodium 20 mg, once daily subcutaneously) in~     women with a history of recurrent miscarriages without identifiable causes versus no~     treatment. The results showed that, there is a significant reduction in the incidence of~     both early and late miscarriages (8.8% vs 4.1%) (2.3% versus 1.1%) with or without~     treatment, respectively.~      Cochrane Database systemic review (2005) shows randomized comparative studies for treating~     recurrent miscarriage in women without antiphospholipid syndrome. The first group treated by~     low dose aspirin alone and the second group treated by low dose aspirin + LMWH. The result~     of these studies shows that no significant differences between the two groups and identify~     the need of large randomized controlled trial to solve this problem.~      The above evidence suggests the probability of presence of untested LAC and aCL or very low~     levels of APLA by commonly used methods in women with recurrent miscarriage. These~     antibodies may explain recurrent miscarriage in cases with negative antiphospholipid~     antibodies. It remains to test the efficacy of heparin (proven effective treatment in those~     with positive antibodies) in the patients with negative antibodies. Finding a solution to~     this frustrating problem may open the way for an unsolved problem.~      The proposed study is an open labeled randomized controlled trial (RCT) To evaluate the~     effect of LMWH versus no heparin in treatment of recurrent miscarriage that is negative for~     antiphospholipid antibodies testing.~   "
110619|NCT01608334|"~     Adequate sensory block for surgical procedure without side effects and immediate~     mobilization after surgery are desirable anesthetic technique in various surgeries.~     Considering the sensory innervations to the prostate, a sensory block up to L1 - T12 is~     adequate to the TURP. Low-dose intrathecal local anesthetics may meet these criteria, but~     occasional lack of sufficient sensory block could be troublesome. In this randomized study,~     the investigators evaluated the spinal anesthetic characteristics following intrathecal~     administration of bupivacaine 1 mg with fentanyl or sufentanil in elderly patients~     undergoing TURP.~   "
110620|NCT01608321|"~     This study was designed to evaluate the effect of repetitive Transcranial Magnetic~     Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the~     first Gulf War (GW1) who often suffer from chronic pain problems.~   "
110621|NCT01608308|"~     The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe~     and efficacious agent in reducing post-operative pain; we hypothesize that its use will~     reduce post-operative pain when compared to a control group using the visual analogue score~     (VAS) analog pain scoring system.~   "
110622|NCT01608295|"~     The purpose of this study is to examine the effects of vilazodone for the treatment of~     depression in older adults.~   "
110623|NCT01608282|"~     OPEN (Osteoarthritis Physical Activity and Exercise Net) is a website created based on a~     well developed behavioural theory. This intervention is developed for people with early knee~     osteoarthritis (OA) who have been sedentary. The investigators aim to engage these~     individuals to become physically active at a time when their joint symptoms tend to be mild.~     The primary goal of this proof-of-concept randomized controlled trial is to determine if the~     OPEN website plus an information pamphlet about OA will improve participation in physical~     activity in persons with early knee OA, compared to those who receive only the pamphlet.~   "
110624|NCT01608269|"~     The purpose of this study is to assess the safety, tolerability, and antivira activity of~     Epzicom in virologically controlled HIV subjects.~   "
110625|NCT01608256|"~     The Purpose of this study is to assess the effect of MCI on driving ability by using on road~     driving test. The relationship between their driving outcome and their cognitive decline~     will be examined.~   "
110626|NCT01608243|"~     The purpose of this study is to investigate the safety of different doses of sublingual~     tablets of house dust mite allergen extracts in adults with house dust mite-associated~     allergic asthma.~   "
110627|NCT01608230|"~     This study is being done to learn more about genetic mutations in cancer cells and to find~     out how the development of new technologies can increase knowledge of these mutations and~     possibly predict an individual's response to certain treatments.~   "
110628|NCT01608217|"~     This is a phase II, randomized, placebo-controlled, double-blind, parallel-group,~     multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural~     disturbances and pain in patients with mild to severe dementia, when added to an analgesic~     treatment with acetaminophen.~      It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo,~     when added to an analgesic treatment with acetaminophen, and as measured by a change in~     Neuropsychiatric Inventory (NPI) score, after a three week treatment period.~      It is expected that this will be due, primarily, to psychoactive effects of Namisol® and~     secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is~     expected that a reduction in NPS will positively affect quality of life and lead to better~     functioning in daily living.~   "
110629|NCT01608204|"~     The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST~     (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be~     utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is~     only checking the GST gene and MDR-1 gene~   "
110697|NCT01607294|"~     This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in~     subjects with type 2 diabetes.~   "
112135|NCT01588509|"~     This is a phase 1, randomized, open-label, parallel group study conducted in healthy~     postmenopausal women with low bone mineral density previously treated with alendronate.~   "
110630|NCT01608191|"~     The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy)~     programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can~     reduce weight gain and improve weight stability, self reported health, pain, eating~     behavior, fatigue and mood.~      Adults with obesity and health problems in primary health care are invited to be part of the~     study. The geographical area is Orebro county which has in all 29 primary health care~     centers. Population is 276 000, and according to population studies around 15% of the adult~     population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to~     WHO.~      Specific objectives are;~        -  To evaluate if internet-based CBT treatment after LCD improves weight stability after 1~          and 2 years.~        -  To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose,~          Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) ,~          triglycerides (TG) and Bloodpressure (BP)~        -  To evaluate weight loss influence on quality of life, body pain, eating behavior,~          obesity related problems, fatigue and mood, and to see if CBT program for weight~          stability also improves these factors~        -  To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary~          health care~      Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD)~     treatment, followed by a 12 week reintroduction to ordinary food. During this period the~     patient has contact with the primary health care nurse and doctor. After 24 weeks of~     treatment, the patient who follows the study is supposed to have lost around 10% of initial~     weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to~     either ordinary follow up (group 1) or an internet-based CBT programme for weight stability~     (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by~     nurse visit.~   "
110631|NCT01608178|"~     Background:~      - Succinic semialdehyde dehydrogenase (SSADH) deficiency is a rare genetic disease that~     results in changes to certain brain chemicals. These chemicals may affect brain~     excitability, or how likely nerve cells are to turn on. Changes in brain excitability may~     help to explain the symptoms of the disease, including learning and memory problems,~     seizures, and poor balance. A supplement called taurine may help people with SSADH~     deficiency by working on the brain chemical GABA. GABA helps to regulate brain activity.~     Researchers want to see if taurine can help people with SSADH deficiency.~      Objectives:~      - To learn more about how taurine affects the brain in people with SSADH deficiency.~      Eligibility:~      - Individuals at least 12 years of age who have SSADH deficiency.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples. They will also take taurine supplements as part of~          this protocol.~        -  Participants will have two sets of study tests. One set will be given while~          participants are taking taurine. The second will be given when they are not taking it.~          Each testing session will take about 2 days to complete.~        -  Half of the participants will have the off taurine testing before starting on the~          taurine supplement. The other half will start taking taurine first, have the on~          taurine testing, and have the off taurine testing about 3 months after stopping~          taurine. Participants may decide the order in which they will have the testing done.~        -  Participants will have the following tests at the two test visits:~        -  Paper and pencil tests of learning and memory.~        -  Transcranial magnetic stimulation to study the excitability of nerve cells.~        -  Imaging studies to show GABA receptors in the brain and measure their activity.~        -  Electroencephalogram to measure brain waves.~        -  Lumbar puncture to collect spinal fluid.~        -  Participants will be monitored with regular study visits while they receive the taurine~          supplement treatment.~   "
110632|NCT01608165|"~     The number of people diagnosed with kidney cancer has doubled over the past 20 years, making~     it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over~     80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread.~     Current standard treatment for these small kidney cancers is to remove the diseased part of~     the kidney in an operation called a partial nephrectomy, but this can be quite a difficult~     operation. Because of the small tumour size and difficulties with the operation, other~     treatments have been developed to destroy the tumours. These treatments include~     radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation,~     which means that the tumour is frozen and destroyed.~      Although removing the part of the diseased kidney in an operation is the tried and tested~     way to treat the kidney cancer, it does have risks and complications, such as bleeding. The~     other two treatments are less intrusive to the patient, and are less complicated as they do~     not require such a large operation as having part of the kidney removed, but it is not known~     if they are as good at destroying all of the tumour, and whether or not patients who have~     their tumour destroyed with these new methods require further treatment in future.~      In this study, the investigators are trying to determine if a large-scale study comparing~     these treatments is possible which is why this is called a feasibility study. The~     investigators are also looking at whether patients would be willing to be randomly assigned~     to a treatment group. The results of this study will then be compared to see how effective~     each of the treatments were and whether the number of patients who were happy to be randomly~     assigned to a treatment could be used to determine the number of patients required in a~     large-scale trial.~   "
110633|NCT01608152|"~     Objectives:~      Aim 1. Develop a prototype intervention electronic game that implements a baseline testable~     feature set, including features for social networking within a virtual game space, managing~     an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem~     solving.~      Aim 2. Evaluate the technical merit, feasibility, user perception and acceptance of the~     prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell~     transplantation (HSCTs) patients in recovery.~   "
110634|NCT01608139|"~     The goal of this clinical research study is to learn the highest tolerable dose of the~     combination of curcumin, vorinostat, and sorafenib that can be given to patients with~     advanced solid cancer. The safety of this drug combination will also be studied.~   "
110635|NCT01608126|"~     The purpose of the study is to compare efficacy, complications and safety of the standard~     method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound~     guided Medial Cervical plexus block technique (MCPB).~      Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.~   "
110636|NCT01608113|"~     Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal~     anti-VEGF and subsequently PRN, will be included in this study. Patients will be~     investigated for the first 2 years monthly and subsequently according to disease activity~     but at least every two months. Patients will be examined with 4m BCVA ETDRS distance visual~     acuity, reading acuity measured by Radner-Reading-Charts, contrast sensitivity by~     Pelli-Robson score, microperimetry and HD-OCT.~   "
110637|NCT01608100|"~     The objective of the study is to evaluate the performance and intended use of a new cardiac~     biomarker test, Troponin I, in an intended use population. Blood specimens will be tested~     using the new investigational test that detects the level of Troponin I. Results will be~     compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.~   "
110638|NCT01608087|"~     This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish~     pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.~   "
110639|NCT01608074|"~     Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral~     salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the~     investigators suggest, is to suppress the tubal source of possible dysplastic cells from~     which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.~   "
110640|NCT01608061|"~     The primary objective of this feasibility study is to evaluate the safety of DBS-f in~     patients with mild Alzheimer's disease by assessing all device and/or therapy related~     adverse events. The secondary objective is to preliminarily estimate the treatment effect~     size on the outcomes of interest at 12 months post-randomization. The objectives do not~     involve formal tests of hypotheses.~   "
110641|NCT01608048|"~     The objective of this study is to investigate the effect of transcutaneous electrical~     acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.~   "
110642|NCT01608035|"~     The goal of this study is to determine if pre-operative placement of the continuous~     peripheral nerve block by an anesthesiologist using ultrasound technology is more effective~     than a continuous peripheral nerve block placed during the surgery by a surgeon for patients~     undergoing a limb amputation~   "
110643|NCT01608022|"~     Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the~     worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness,~     resulting in a median survival of 8 months to 10months. The low activity and brief duration~     of benefit for chemotherapy to palliate advanced disease make clear need to identify new~     active agents.~      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with EC. The association between EGFR-activated signaling~     pathways and tumor cell survival are well documented in many studies. Some EGFR tyrosine~     kinase inhibitors (TKIs) already showed clinical efficacy against EC. A study with erlotinib~     showed objective response rate of 15% (2 of 13 patients), but activity was limited to~     squamous cell type.8 In another study, thirty patients with malignant solid tumor were~     treated with BIBW2992, irreversible inhibitor of EGFR and HER2, and one of four EC patients~     achieved partial response.~      PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In~     preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines~     engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth~     inhibition in gefitinib-resistant xenografts. PF-00299804 reportedly have clinical~     anti-tumor activity in patients with non-small cell lung cancer and head and neck squamous~     cell carcinoma with manageable toxicity.~      The aim of current trial is to evaluate the antitumor efficacy and safety profile of~     PF-00299804 and to identify biomarker to predict the tumor response to PF-00299804.~   "
110644|NCT01608009|"~     The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to~     pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and~     paclitaxel in platinum-resistant ovarian cancer patients.~   "
110645|NCT01607996|"~     The aim of the study is to evaluate the safety, the potential beneficial effect of epidural~     anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute~     pancreatitis.~   "
110646|NCT01607983|"~     The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial~     coupling in patients with congenital heart disease and passive pulmonary blood flow.~     Consenting patients undergoing a clinically-indicated cardiac catheterization will be given~     inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be~     make via conduction catheters.~   "
110647|NCT01607970|"~     The purpose of this study is to determine whether oxytocin affects the modulation of startle~     reactivity by aversive social stimuli and to investigate the oxytocin effect on moral~     judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR)~     polymorphisms on behavioral responses to social stimuli.~   "
110648|NCT01607957|"~     The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in~     patients with refractory metastatic colorectal cancer.~   "
110649|NCT01607944|"~     Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are~     glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the~     glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic~     endocrine function and incretin metabolism are impaired. The investigators hypothesize that~     extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in~     subjects with type 2 diabetes.~      Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief,~     somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of~     insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be~     studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject~     will undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or~     GIP. Glucose metabolism will be assessed using 13C-glucose stable isotope methodology~     combined with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and~     flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and~     abdominal adipose biopsies will be taken to examine intracellular signalling.~   "
110650|NCT01607931|"~     Human volunteers will be stratified by oral glucose tolerance status: normal glucose~     tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4~     experimental trials: [1] an oral glucose tolerance test (OGTT) combined with infused and~     ingested stable isotopes of glucose to assess glucose kinetics. [2] a 1 hour bout of cycling~     exercise at 50% of maximum power output, immediately followed by the same OGTT combined with~     stable isotope glucose tracers used in trial 1. [3] an isoglycemic clamp to match the plasma~     glucose profile measured in trial 1. [4] a 1 hour bout of cycling exercise at 50% of maximum~     power output, immediately followed by an isoglycemic clamp to match the plasma glucose~     profile measured in trial 2.~      Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon~     secretion, and the incretin effect will be examined. The exercise responses will be compared~     between the subjects groups of different glucose tolerance status.~   "
110651|NCT01607918|"~     The investigators aimed to compare the eradication rates of sequential therapy for 10 days~     versus triple therapy for 14 days~   "
110652|NCT01607905|"~     Phase 1 study to evaluate the safety and tolerability of KPT-330 and determine the~     Recommended Phase 2 Dose (RP2D) of KPT- 330 for advanced or metastatic solid tumor~     malignancies.~   "
110653|NCT01607892|"~     The purpose of this research study are to find out more information such as: the highest~     dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the~     body affects the study drug concentrations in the blood (pharmacokinetics or PK), to examine~     the effects of this study drug on the body (pharmacodynamics or PDn) and to gain some~     information on its effectiveness in treating cancer.~   "
110654|NCT01607879|"~     This is a study of HMB plus amino acids in older men with prostate cancer starting androgen~     deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional~     supplementation will decrease the loss of muscle mass and strength that occurs when men~     start ADT.~   "
110655|NCT01607866|"~     The most common benign tumor of the parotid gland is the so called pleomorphic adenoma.~     Although benign, this tumor may recur after surgical removal due to tumor cells left behind~     during the surgical operation. Thus, pleomorphic adenomas have been treated with wide~     resection similar to malignant tumors. This extensive surgery often leads to injury to the~     motor nerves responsible for facial expression and eye protection. The investigators propose~     less extensive surgery which should be thorough enough to prevent tumor recurrence while~     keeping the facial nerve out of risk.~   "
110657|NCT01607840|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities and alter functional connectivity in individuals~     with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak~     electrical current to the surface of the scalp while participants complete cognitive tasks.~     Participants also receive a brain scan before and after stimulation. Our aim is to determine~     if tDCS can improve mental abilities in individuals with schizophrenia.~   "
110658|NCT01607827|"~     The investigators aim to assess the procedure time and miss rate of polyps when performing~     polypectomy in the colon on the way up* and down** or only on the way down**.~      (* advancing the scope to the cecum, ** pulling back the scope after intubation of the~     cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on~     the way up and secondly on the way down is less time consuming and misses less polyps as~     with the strategy to remove polyps only on the way down.~   "
110659|NCT01607814|"~     Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in~     primary and secondary haemostasis.~      Such changes have been considered particularly relevant in the bleeding complications that~     occur in cirrhosis.~      However, several studies have shown that routine diagnostic tests are not clinically useful~     to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase~     platelet count or to modulate platelet function could potentially do harm. Consequently the~     optimal management of bleeding complications is still a matter of discussion.~      Moreover, in the last two decades there has been an increased recognition that not only~     bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last~     years, emerge that in vivo platelet function and coagulation cascade might be modulated by~     an alteration of pro-oxidant and antioxidant balance. Thus It has previously been~     demonstrated that chronic liver diseases are characterized by increased oxidative stress~     state.~      Aim of the study is to analyse the relationship between oxidative stress, haemostatic~     balance and clinical complications in cirrhosis.~   "
110660|NCT01607801|"~     background Operation for small umbilical hernias is one of the most common surgical~     procedures, but the best surgical technique, including the choice of suture or mesh remains~     unknown.~      It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the~     risk of incisional hernias and wound healing problems.It has also been found that the use of~     resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of~     recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use~     of the mesh in open operation for a small umbilical hernia has lower risk of recurrence~     (approx. 1-3%) than sutured repair (10-12 %). However, the scientific literature is~     deficient, with few patients.~      The purpose of this study is to describe reoperation rate of recurrence after small~     umbilical hernias, depending on choice of sutures in both regular repair and in mesh repair.~      Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with~     other types of sutures, whereas mesh repair has even lower recurrence rates in small~     umbilical hernia repairs.~   "
110661|NCT01607788|"~     The investigators propose a prospective, web-based database (developed within the framework~     of Quickbase, Intuit) which will allow an evaluation of the data for patients with a liver~     tumour who receive a liver transplant. Each site will continue to transplant according to~     their own criteria for inclusion on the waiting list. Each center will be responsible to~     enter a short list of data points at time of listing, transplant, and at 1 and 2 years post~     transplant. Data will be gathered prospectively through a web-based anaonymized database,~     and outcomes analyzed yearly X5 for tumour recurrence and patient survival.~   "
110662|NCT01607775|"~     Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate~     cage was designed and prospectively implanted in patients with a mono- or bilevel cervical~     pathology. As control, a commercially available PEEK-cage was used, patients were randomized~     using minimization randomization, controlling for age and bone mineral densitiy. The~     investigators hypothesize that the newly developed cage has similar clinical and~     radiological qualities compared to the PEEK-cage, but at a much more favourable~     cost-performance ratio.~   "
110663|NCT01607762|"~     The purpose of this study is to compare capillary (the smallest of a body's blood vessels)~     and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single~     oral, immediate-release dose to healthy participants.~   "
110664|NCT01607749|"~     Undertake a study of educational intervention in primary schools in Andalusia~      HYPOTHESIS:~      There are differences in quality of life associated with asthma (as measured by the~     questionnaire PAQLQ) and the level of asthma control in students with asthma aged 11 and 12~     years who receive an educational intervention with their peers without asthma versus those~     receiving standard information in schools.~      OBJECTIVES: To compare the control of asthma symptoms, quality of life in asthma and asthma~     knowledge among a group receiving an educational intervention delivered by specialist~     teachers of physical education (MEEF) in Primary Schools (CEIP) and control.~      MÉTODOS group: Randomized controlled single-blind.~      POPULATION: Students of 11 and 12 years old in Andalusia~      Sample size: 258 children / children with asthma for a mean contrast (alpha error of 3.4%.~     80% power, a confidence level of 95% considering 20% loss. 2580 students will be enrolled~     prevalence of asthma 10%) . Conglomerates of the CEIP in urban, rural, public and~     private-reached.~      INTERVENTION: Training MEEF with the educational program Sports and Health Asthma and~     subsequent delivery, then the students MEEF are 5th and 6th grade ( 3 sessions). CONTROL:~     The standard instruction in schools. OUTCOME VARIABLES: Quality of life (Juniper) and~     control del asthma en niños(CAN) in asthmatics, Knowledge (NAKQ questionnaire) and~     attitudes toward asthma (all students and teachers). Pre-intervention (T0),~     post-intervention at 5-6 months (T1)~      Independent variables: Sex, suffering or not asthma, intervention / control, type CEIP.~      STATISTICAL ANALYSIS: Comparison of continuous variables: T Students (If normal~     distribution) Mann-Whitney (If non-normal distribution). To study qualitative variables~     chi-square test (normal distribution) and Kruskal-Wallis ( no-normal distribution).~   "
110665|NCT01607736|"~     Older individuals suffer from falls and fear of falling. The purpose of this study was to~     determine the effectiveness of a novel virtual gait training on walking performance and fear~     of falling in older adults, and to evaluate the feasibility of the virtual gait training~     program. The investigators hypothesize that virtual gait training in older adults over a~     three week period will both improve gait parameters as measured by a GAITRite® electronic~     walkway system, and reduce their fear of falling as measured by the Falls Efficacy~     Scale-International version.~   "
110666|NCT01607723|"~     Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +)~     are new modes of mechanical ventilation that delivers ventilatory assist in proportion to~     the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The~     goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator~     asynchronies, and sleep pattern between NAVA and PAV+.~   "
110667|NCT01607710|"~     The investigators are seeking to locate the brain regions of interest in generalized anxiety~     disorder (GAD) using both structural (sMRI) and functional magnetic resonance imaging~     (fMRI). The MRI will be used to measure changes in blood flow in the brain while at rest and~     while completing tasks designed to elicit symptoms of anxiety. Results from a nonclinical~     control group and a GAD group will be compared to determine whether they exhibit different~     areas of brain activity during the tasks.~   "
110668|NCT01607697|"~     Scientific Abstract:~      The investigators propose a study to examine the impact of a Mindfulness Based Intervention~     (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's~     disease (PD).~      NMS add significantly to the disease burden and negatively impact the quality of life in PD~     (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD~     patients with either early- or late-onset of disease (3). Despite currently available~     treatments, PD leads to worsening disability and there remains a need for new approaches. A~     Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of~     PD in relation to NMS and quality of life.~      A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU)~     groups. Clinical assessments (motor and non-motor scores) will be performed in both groups.~     The TAU group will be offered MBI after completion of the study.~      To the best of our knowledge, this is the first large scale study using MBI in this~     indication.~   "
110669|NCT01607684|"~     The purpose of this study is to determine whether Magnetic Marker Monitoring is an~     appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects~     with diabetic polyneuropathy.~   "
110670|NCT01607671|"~     The purpose of this study is to evaluate the feasibility of rapid evaluation and~     administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior~     ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the~     progression or improves recovery of patients who are randomly assigned to treatment versus~     standard of care.~   "
110671|NCT01607658|"~     The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2~     intranasal testosterone gel to placebo on the occurrence of orgasm.~   "
110672|NCT01607645|"~     The goals of this study are to learn about the effectiveness, the side-effects, if waiting~     to give the idarubicin and cytarabine may change the side effects or effectiveness, and to~     identify factors to predict for responses to this therapy. The trial will examine~     combination of three chemotherapy drugs. These drugs are decitabine, idarubicin, and~     cytarabine.~   "
110673|NCT01607632|"~     A before and after study of veterans who took part in a 12-week loving-kindness meditation~     course as an adjunct to their usual care for posttraumatic stress disorder.~   "
110674|NCT01607619|"~     The investigators are studying a dietary supplement called anatabine in a lozenge form named~     RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement~     on normal human inflammatory function. The investigators will see this effect in volunteers~     who have markers of higher levels of inflammation to begin with. The investigators~     anticipate that anatabine will reduce markers of inflammation. Therefore the investigators~     are looking for volunteers with high blood levels of C-reactive Protein (CRP) and will~     monitor the blood CRP levels at several time points throughout the study.~   "
110675|NCT01607593|"~     This is a multicenter retrospective study to investigate the dosage regimens of sertraline~     in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and~     the efficacy and safety of this drug in patients with PTSD. Data will be collected from the~     medical records of patients with PTSD.~   "
110676|NCT01607580|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia. However, GVHD rate was still high after haploidentical~     HSCT.~      It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft~     was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).~      The study hypothesis:~      Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after~     unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of~     acute GVHD~   "
110677|NCT01607554|"~     Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs~     and other agents. There is a factor called ISG15 which might help doctors better identify~     patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive~     to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases.~     Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in~     cell growth, and it has been FDA approved for 17 years for another type of cancer.~   "
110678|NCT01607541|"~     Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all~     adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment~     delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly~     less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience~     serious barriers to entering care compared to other groups. The investigators research team~     has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral~     Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among~     HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in~     central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS~     methodology to target HHR in central Brooklyn.~      The primary goal of the proposed study is to evaluate the efficacy of a peer-driven~     intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare~     the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a~     peer-based approach) versus venue-based sampling (a location-based approach).~      The two main study hypotheses are:~      (H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test~     positive for HIV compared to those recruited via venue-based sampling (VBS).~      H2): Participants in the Test and Treat: phase of the peer-driven intervention (all of whom~     will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter~     time to starting HIV medication (when medically indicated), higher rates of viral load~     suppression, and higher rates of retention in care compared to those in the control arm.~   "
112136|NCT01588496|"~     A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in~     patients with homozygous familial hypercholesterolemia (HoFH).~   "
110679|NCT01607528|"~     Liver cirrhosis is the 10th most common cause of death in the western world. Infection is~     the most common precipitant of deterioration of liver function in cirrhosis. Endotoxin,~     derived from gram-negative organisms in the gut, can enter the circulation due to increased~     gut permeability and contributes to neutrophil dysfunction, infection risk and mortality in~     alcoholic cirrhotics. As probiotics decrease gram-negative organisms in the gut and/or~     decrease gut permeability, the investigators hypothesize that probiotic treatment would~     restore neutrophil function and prevent infection in alcoholic cirrhosis.~      The investigators hypothesize that administration of a probiotic mixture in patients with~     liver cirrhosis will improve innate immune function through alteration of the gut bacterial~     flora and gut barrier integrity.~      The aim of this randomised, double-blinded placebo-controlled study is to assess whether~     food supplementation with probiotic mixture improves neutrophil phagocytic capacity in~     patients with cirrhosis and decreases the incidence of significant infections.~      92 patients with alcoholic cirrhosis will be included according to a sample size calculation~     from preliminary data. Patients will be randomized in two groups: Group 1 receives a~     probiotic mixture Group 2 receives a similar looking and tasting placebo without bacteria.~     The recruited patients will be treated for 6 months. Besides routine clinical and laboratory~     assessments, neutrophil function, toll-like receptor expression, endotoxin levels, bacterial~     DNA, cytokine levels, albumin oxidation, gut permeability and analysis of gut microflora~     will be performed. Furthermore nutritional status and quality of life will be assessed.~      Primary endpoints will be neutrophil phagocytosis. Secondary endpoints will be significant~     infection, neutrophil oxidative burst, neutrophil toll-like receptor expression, endotoxin~     levels, bacterial DNA; cytokine levels, albumin oxidation, gut barrier function and~     bacterial flora, nutritional status and quality of life.~      If our hypothesis holds true, probiotics will provide an easily applicable and cost~     effective method to improve immune function and to prevent infection in liver cirrhosis. It~     is possible that this can improve survival of patients with liver cirrhosis.~   "
110680|NCT01607515|"~     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25~     mmHg in the right heart catheterization.~      There are different forms of PH defined in the classification of Dana Point 2008.~      PH is diagnosed with right heart catheterization but there are other non invasive methods~     which can be used for screening like echocardiography, stress echocardiography and cardio~     pulmonary exercise testing.~      For prognosis of PH patients the limitation of the pulmonary circulation is very important.~     Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The~     gold standard for CI measures is the thermodilution, an invasive method performed during~     right heart catheterization.~   "
110681|NCT01607502|"~     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25~     mmHg measured in the right heart catheterization.~      There are different forms of PH defined in the classification of Dana Point 2008.~      PH is diagnosed with right heart catheterization but there are other non invasive methods~     which can be used for screening like the echocardiography, stress echocardiography and~     cardio pulmonary exercise testing. In the diagnosis process and in the follow up of PH~     patients biomarkers like NTproBNP are helpful. There are no specific biomarkers for the~     disease which can make the diagnosis process easier and predict prognosis.~      The systematic data collection in a data base provides better information about patients in~     daily routine and clinical studies as well as in the design of new studies.~   "
110682|NCT01607489|"~     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of~     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT).~     In this pilot study the investigators investigate patients who underwent right heart~     catheterisation with DE-CT to determine hemodynamic parameters and control the results by~     other clinical investigations. The investigators expect that using this non-invasive method,~     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,~     blood flow and perfusion heterogeneity, can be determined.~   "
110683|NCT01607476|"~     The intent of this research protocol is to test the equivalency of two amyloid imaging drugs~     (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there~     will be no significant difference in the distribution of the agents to areas of amyloid~     deposition in the brain or to other normal brain structures. Recent data have shown~     similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or~     mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects~     has been published. It is important to understand differences in the images and~     biodistribution from the two drugs in normal subjects as nonspecific accumulation of the~     drugs in brain structures such as white matter appear to differ slightly and could affect~     image performance.~   "
110684|NCT01607463|"~     The purpose of this study was to investigate whether transcutaneous electrical nerve~     stimulation (TENS) could reduce pain during cannulation of vein.~   "
110685|NCT01607450|"~     The objective of this proposal is to provide quantitative dose-response data for effects of~     GLP-1 on myocardial glucose uptake in healthy control subjects and obese type 2 diabetic~     subjects, in support of the design of later studies evaluating therapeutic applications of~     GLP-1 to heart disease.~      Aim 1: To measure the effects of GLP-1 infusion on myocardial fuel selection in lean healthy~     humans under fasting (fatty acid-dominant) conditions. Four groups of 10 lean healthy~     subjects will be studied during infusions of 0 (saline control), 0.5, 1.5, and 4.0~     pmol/kg/min GLP-1 (one study per subject). Cardiac metabolism will be measured using PET,~     using a dual-tracer approach which allows measurement of myocardial glucose uptake (the~     primary endpoint) along with total oxidation rate and myocardial perfusion (secondary~     endpoints). In concert with measures of circulating metabolites and regulatory hormones, the~     investigators will produce the most comprehensive assessment of actions of GLP-1 on~     myocardial metabolism in humans to date. Effects of each dose will be compared to the saline~     control, plus the investigators will combine all data and use nonlinear curve-fitting to~     derive sensitivity (ED50) and maximal responses for GLP-1 effects on myocardial glucose~     uptake.~      Aim 2: To measure the effects of GLP-1 infusion on myocardial fuel selection in obese type 2~     diabetic humans under fasting (fatty acid-dominant) conditions Four groups of 10 obese type~     2 diabetic subjects will be studied during infusions of 0, 0.5, 1.5, and 4.0 pmol/kg/min~     GLP-1 as under Aim 1. Analyses will be parallel to those described under Aim 1. Results from~     Aims 1 and 2 will be combined to allow direct comparison of the dose-response between~     nondiabetic control and type 2 diabetic subjects.~      No literature has been published to inform dose selection in the design of clinical trials~     of GLP-1 for modulation of heart fuel selection. With our expertise and experience in PET~     measurement of heart metabolism in diabetes, the investigators are uniquely positioned to~     fill this gap in knowledge. These studies are a necessary preamble to further evaluation of~     the potential for GLP-1 based treatments in heart disease.~   "
110686|NCT01607437|"~     No former studies have done long-term evaluation on patients reconstructed with hamstrings~     graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel.~     The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum~     of 10 years after surgery. According to former published studies on alike methods, the use~     of transtibial drilling of the femoral graft tunnel causes an increased rotational~     instability of the knee. The investigators aim to map the clinical stability of this group~     as well as evaluating the general outcome at the long-time horizon.~   "
110698|NCT01607281|"~     The study is designed to determine anaesthetists ability to locate the right internal~     jugular vein(IJV) and left IJV using a landmark technique. Initially, a questionnaire was~     completed detecting previous user experience. An ultrasound probe, using the midpoint as an~     'imaginary needle', was placed on the neck of a healthy volunteer and the image recorded.~     Both anaesthetist and volunteer were blinded to the screen until the image was stored.~     Anaesthetists were grouped into senior or junior by the total number of IJV canulation~     experience. The success rate is going to be measured as pass or fail.~   "
144281|NCT01166087|"~     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride~     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.~   "
110687|NCT01607424|"~     Rationale:~      Cognitive deficits are a core feature in schizophrenia. Conventional treatments~     (antipsychotic medication and psychological treatments) have limited effects so cognitive~     remediation programs were designed to alleviate the problems. Interventions typically~     involve a variety of exercises in a paper and pencil or a computerized format with a growing~     number of specialized computer programs now being developed. However, many of these programs~     lack specificity which does not allow an individual's specific needs to be addressed. More~     targeted interventions might increase the effects of therapy so RECOS - COgnitive~     REmediation for Schizophrenia - was developed to fit this gap.~      Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to~     45 years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an~     already validated program (CRT).~      220 patients will be randomized as follows :~        -  Arm 1 : RECOS (42 h)~        -  Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris,~          Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.~   "
110688|NCT01607411|"~     An in situ model will be used to evaluate and compare enamel remineralization of human~     enamel specimens after single use of experimental children's toothpastes.~   "
110689|NCT01607398|"~     The study will be conducted in a respiratory specialist institute in Japan, with~     standardized techniques and data assurance checks to optimize data quality. The licensed~     dosage and administration of Adoair in Japan will be applied in this study. Each subject~     will receive treatment options in a randomized blinded fashion. Subjects will be randomized~     following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo~     twice daily for 12 weeks.~   "
110690|NCT01607385|"~     A single blind, randomized, placebo-controlled, dose escalating study to evaluate the~     safety, tolerability, pharmacokinetic and pharmacodynamic parameters of repeat doses of~     GSK2330672 in healthy volunteers, given alone and with a single day of dosing with~     GSK1614235~   "
110691|NCT01607372|"~     GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates~     preferentially the induction of type I interferons. Intranasal (i.n.) administration of~     GSK2245035 in humans causes immune changes in the upper airways milieu that may alter~     bystander immune responsiveness to aeroallergens and contribute to reduction of allergic~     reactivity in subjects with respiratory allergies. The purpose of this study is to examine~     the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with~     respiratory allergies. The safety and pharmacodynamic response of four weekly~     administrations of escalating doses of i.n. GSK2245035 will be investigated and the maximum~     tolerated dose will be established. The study will be conducted in patients with symptomatic~     allergic rhinitis and mild asthma. The overall duration of the study will be up to a maximum~     of approximately 122 days considering 90 days screening period, 22 days treatment period and~     10 days follow-up period.~   "
110692|NCT01607359|"~     Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter~     ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with~     warfarin are well established, the relative risk and benefit of dabigatran in this setting~     are unknown. The purposes of the study are to assess the efficacy of warfarin versus~     dabigatran in the prevention of stroke and other systemic embolic complications before and~     after catheter ablation for AF, and to compare the prevalence of serious bleeding~     complications with the two OAC agents.~   "
110693|NCT01607346|"~     This is a multicentre, open label study to examine the effect of ezogabine/retigabine on the~     voiding function of adult subjects with drug-resistant partial onset seizures (POS).~     Subjects fulfilling the study entry criteria at Screening and at Baseline including a~     comprehensive eye examination by an ophthalmologist or retina specialist and a skin~     assessment by the investigator will receive ezogabine/retigabine.~      The starting dose of ezogabine/retigabine will be 300 mg/day. Subjects will be up titrated~     by 150 mg/day weekly up to the maximum ezogabine/retigabine daily dose of 1200 mg (or the~     highest tolerated dose). During the 49 days of the treatment phase, subjects will undergo~     three repeat non-invasive assessments of voiding function. In addition, subjects who meet~     pre-determined criteria for voiding dysfunction will undergo multichannel cystometry in~     order to characterise bladder hypocontractility, bladder outlet obstruction or a combination~     of events which clinically is manifest with difficulty emptying the bladder or acute urinary~     retention.~      At the end of the Treatment Phase, all subjects will enter the Taper Phase, a 3-week down~     titration period. Subjects who have new findings of abnormal pigmentation of the retina,~     unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin,~     lip, nail, or mucosa since baseline will be asked to enter the Safety Follow-Up /~     Continuation Phase. All subjects will undergo 6-monthly comprehensive eye examinations~     during the Safety Follow-Up / Continuation Phase. Subjects who have not developed abnormal~     discoloration of the skin, lips, nails or mucosa will continue to undergo skin assessments~     by the investigator. Any subject who has developed abnormal discoloration of the skin, lips,~     nails or mucosa since baseline will be referred to a dermatologist for evaluation and~     6-monthly follow up assessments. All subjects will continue to be followed until the~     pigmentation and/or discoloration has resolved or stabilised, as defined by no change over 2~     consecutive 6-monthly assessments conducted over at least 12 months after discontinuation of~     ezogabine/retigabine.~   "
110694|NCT01607333|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      In the present project, investigators use Columbia Classification Algorithm of suicide~     assessment (C-CASA) definitions as a basis to specify the operational definitions of the~     different aspects of suicidality. The focus of the main analyses is on attempted suicide~     including completed suicide. This is due to statistical power issues. However, investigators~     will apply two additional outcome definitions in sensitivity analyses: 1) completed suicide~     only and 2) completed suicide, suicide attempt, preparatory acts toward imminent suicidal~     behavior, suicidal ideation plus indeterminate or potentially suicidal events. Investigators~     will not include terms which clearly indicate an accidental event, or self-injurious~     behavior without a suicidal intent. These definitions are listed in the statistical analysis~     plan together with lists of terms from the dictionaries used in the different databases.~      The objectives of this study are to 1) Compare the study results which are based on two data~     sources (he UK General Practice Research Database (GPRD) and Danish registries) and~     different designs and evaluate the impact of design and population differences on the~     outcome of the study results (the UK database 'The Health Improvement Network' (THIN) may be~     included in these analyses as well); 2) Evaluate the strengths and weaknesses of the two~     data sources to study a possible association of antiepileptic drug (AED) use and~     suicidality, in particular the specific outcomes of death from suicide, hospitalization due~     to suicide attempt, and reports of the aspects of suicidality by the patients; 3) Estimate~     risks of completed suicide, completed suicide and attempted suicide, and completed suicide,~     suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation plus~     indeterminate or potentially suicidal events overall for all AEDs and by individual AEDs~     prescribed in UK and Denmark; and 4) Describe the patterns of AED prescribing in six~     European databases (GPRD and THIN, UK; Danish registries; Mondriaan, Netherlands; Bavaria,~     Germany; Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria~     (BIFAP), Spain).~   "
110695|NCT01607320|"~     This study examines Raloxifene versus Clomiphene to induce ovulation in women with~     polycystic ovarian syndrome (PCOS).~   "
110696|NCT01607307|"~     A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese~     herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the~     prevention of postoperative paralytic ileus.~   "
110699|NCT01607268|"~     This research study will be conducted in patients with primary autonomic failure, a~     disabling condition that is associated with low blood pressure upon standing. These patients~     are also not able to control for changes in their blood pressure due to a loss of~     cardiovascular reflexes that are mediated within the brain. The purpose of this study is to~     determine whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique,~     can measure levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area~     important for control of cardiovascular function, in autonomic failure patients.~     Importantly, this study will determine whether there are differences in brain chemicals~     between patients with peripheral versus central origins of their autonomic failure. The~     hypothesis is that the neurotransmitter profile in the medulla will be intact in patients~     with peripheral autonomic failure compared to those with central impairment. Overall, this~     study will provide insight into understanding the mechanisms involved in autonomic failure~     and will determine whether a single session of MRS imaging can improve the ability to make~     an accurate diagnosis in these patients. This would lessen the need for more extensive and~     invasive clinical testing.~   "
110700|NCT01607255|"~     Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal~     cancer screening. Population studies have shown that traditional air colonoscopy fails to~     eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The~     investigators aim to establish the superior effectiveness of combining chromoendoscopy with~     the water exchange method in detecting more proximal diminutive adenomas during screening~     colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical~     colonoscopy will minimize the risk of missed lesions. The improvement may translate into a~     remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher~     adenoma detection rate may minimize the burden of post screening colonoscopy interval~     colorectal cancers among the veteran population.~   "
110701|NCT01607242|"~     Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and~     swallowing function.~   "
110702|NCT01607229|"~     SPECIFIC AIM:~      Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium~     water (D2O) measurements.~      HYPOTHESIS:~      The Biospace Body Composition Analyzers are valid tools for measuring total body water and~     body composition.~   "
110703|NCT01607216|"~     This is an observational study that proposes to collect clinical, physiological, cellular~     and molecular information in an attempt to identify a set of factors that may predict the~     risk for persistent lung disease in babies born prematurely.~   "
110704|NCT01607203|"~     The purpose of this study is to see whether patients triggered with only human Chorion~     Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate~     than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH)~     agonist.~   "
110705|NCT01607190|"~     The purpose of this study is to validate a predictive model of diabetic retinopathy~     progression in patients with diabetes mellitus type 2 patients to clinically significant~     macular edema (CSME) needing treatment either photocoagulation or intravitreal injections~     (ITV) using non-invasive techniques.~   "
110706|NCT01607177|"~     Preoperative exercise has been shown to improve physiological and functional capacity in~     patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients~     undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the~     setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is~     also thought to increase the likelihood that they will exercise postoperatively. However,~     compliance to this advice is extremely low. Text-message interventions have been shown to~     improve compliance to other lifestyle interventions. The investigators will compare the rate~     of compliance to preoperative exercise prior to bariatric surgery in patients who receive a~     daily text message to those who do not. The investigators will also compare weight loss.~   "
110707|NCT01607164|"~     This study is pilot testing a self-help automated Website (similar to a self-help book)~     designed to help individuals to learn methods to manage their mood. The methods are~     cognitive-behavioral skills found effective in the treatment of depression when provided by~     live therapists. The purpose of the study is to determine the number of individuals who will~     visit the site, use the site, and respond to online surveys reporting their mood levels~     while using the site, and at 1, 3, and 6 months after starting to use the site. The~     investigators want to eventually examine whether learning these methods online would help~     prevent depression.~   "
110708|NCT01607151|"~     Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited~     experience with the use of TTM after intracerebral hemorrhage (ICH), the most devastating~     type of stroke. TTM may be a an intervention to improve patient outcomes. This trial~     addresses the safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may~     be the basis for future larger clinical trials.~   "
110709|NCT01607138|"~     Swallowing and speech difficulties will be observed in patients post laryngectomy. These~     difficulties will cause decreased in quality of life.~   "
110710|NCT01607125|"~     The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in~     neural activity (BOLD signal), as measured using fMRI, in brain areas associated with~     executive functioning and memory during cognitive task performances compared to placebo in~     subjects remitted from depression and in controls, and to explore if Vortioxetine will lead~     to improved cognitive performance in the absence of depression.~   "
110711|NCT01607112|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in~     adults (18 to 60 years) and in elderly (over 60 years).~   "
110722|NCT01606969|"~     Scalp infiltration with Epinephrine- containing lidocaine solution is common method for~     craniotomy but it may result in transient but significant hypotension in patients undergoing~     neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently~     reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine~     response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus~     theologically appropriate for reducing bleeding during scalp incision in craniotomy.~      The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on~     hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.~   "
144282|NCT01166074|"~     This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants~     less than two years old.~   "
110712|NCT01607099|"~     For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g.~     macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6~     liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the~     examination). One handicap of using polyethylene glycol is the occurence of nausea and~     vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a~     pilot study the investigators have detected a high fraction of patients who consider the~     cleansing procedure wich macrogol as very distressing. Thus patient acceptance of the~     colonoscopy procedure altogether is low.~      Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in~     Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of~     sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are~     instructed to drink plenty of water in addition to the laxative. In the mentioned pilot~     study the investigators found the cleansing procedure with picosulfate/magnesium citrate to~     be much more compatible compared to the macrogol regime. The effectiveness expressed by the~     cleanness of the bowel was equal in both groups.~      The investigators believe that a new protocol which contains sodium picosulfate/magnesium~     citrate instead of macrogol will benefit the patients by fewer abdominal side effects while~     cleanness of the bowel at the same time will be warranted. This presumption is the reason~     for the present study.~   "
110713|NCT01607086|"~     The objective of this sensory analysis study is to determine whether volunteers observe a~     significant difference in organoleptic properties between lamotrigine (430C78) cherry~     flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally~     disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid,~     whereby physicians and patients may assess the personal acceptability of the organoleptic~     properties and potential convenience prior to prescription of the ODT formulation.~   "
110714|NCT01607073|"~     This study will assess how well the drug verapamil can improve control of seizures and~     dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The~     safety of verapamil when given with all concomitant medications will also be assessed.~   "
110715|NCT01607060|"~     MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent~     complication in critical ill patients. The disaccharide lactulose has a laxative osmotic~     activity. Given the scant evidence and the potential risk associated with constipation in~     seriously ill patients, this study aims to assess the impact of laxative therapy in the~     prognosis of critically ill patients.~      Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction~     and if treated can result in improved prognosis for critically ill patients.~   "
110716|NCT01607047|"~     Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the~     tropics, where conditions for transmissions are favorable. The disease is endemic in~     Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical~     areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains~     and contaminate the environment by shedding the organisms in their urine. Humans are usually~     infected through abraded skin or mucous membrane contact with water contaminated by the~     urine of animal reservoirs, and less frequently by direct contact with animals or their~     urine. The mean incubation period is 10 days, with a usual range of 2-20 days. Clinical~     manifestations are protean and the spectrum of symptoms range from subclinical or mild~     anicteric febrile illness to acute renal failure and respiratory distress syndrome which are~     associated with high mortality rates.~      The microscopic agglutination test (MAT) and culture are the reference standard test for~     diagnosis of leptospirosis, but they are only available in reference laboratories and their~     conclusive results requires convalescent sample or prolonged incubation. At present, only~     direct detection methods using PCR might provide rapid diagnosis during the early acute~     stage of the illness, when treatment is likely to have the greatest benefit.~      Quantitative PCR also offers the ability to measure level of leptospiremia in clinical~     samples. Using qPCR based diagnosis, the investigators have the opportunity to study the~     association of level of leptospiremia and clinical manifestations in French West Indies. All~     qPCR-positive samples will be used for molecular typing.~   "
110717|NCT01607034|"~     To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in~     intact tablet form in the fasted and fed states in healthy volunteers.~   "
110718|NCT01607021|"~     The aim of this study is to investigate the relationships between interleukin 28B genetic~     variants and the response to treatment of chronic hepatitis C in Chinese children.~   "
110719|NCT01607008|"~     Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External~     beam radiation therapy is one of the common methods to treat prostate cancer. Although~     radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic~     ratio. Those side effects are usually associated with the radiation damage of the normal~     tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and~     the side effects of radiation treatment are often accessed after whole course of~     radiotherapy, which makes the early intervention difficult. The current research project is~     a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to~     access radiotherapy treatment response of prostate cancer during and right after~     radiotherapy.~      Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic~     contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments~     for diagnostic purpose. This research project is to study the feasibility of using advanced~     MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes~     revealed from MRI can provide physicians early information on possible tumor recurrence and~     normal tissue toxicity, therefore, the early intervention may be possible to spare normal~     tissue and cure the patient. The project is designed to combine several different advanced~     MRI imaging techniques systematically to study tissue changes during radiotherapy, which has~     not been seen elsewhere to date.~      Another important goal of this research project is to study the feasibility of associating~     functional MRI with radiation treatment dose distribution. Tissue response during radiation~     treatment depends on dose. The functional MRI can provide more information than simple~     anatomic information. Mapping the functional MRI spatially and associating them with 3D dose~     distribution in radiation treatment planning system is one important step to quantitative~     assess the relationship between radiation treatment and tissue changes due to the radiation.~   "
110720|NCT01606995|"~     This is an international observational study in patients with non-valvular atrial~     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent~     stroke or non-central nervous system systemic embolism.~   "
110721|NCT01606982|"~     The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor~     its safety in patients with metastatic castration-resistant prostate cancer previously~     treated with docetaxel-based chemotherapy.~   "
110723|NCT01606956|"~     Partial cuff inflation before insertion is generally used for laryngeal mask airway~     insertion in adult patients. However, it is not proven how much the cuff should be inflated.~     The aim of this study is to compare efficacy between the method using the resting volume and~     the method using half the maximum volume for partial cuff inflation.~   "
110725|NCT01606930|"~     The purpose of this controlled pilot study is to determine whether an intervention aimed at~     patients will improve partnering, shared decision-making and open communication. Results~     from this pilot study will inform how to best proceed with a larger multi-centered~     randomized controlled trial.~      The specific hypothesis for this pilot study is to:~        1. Test the feasibility of a simple patient-centered intervention.~        2. Test the correlation between patient readiness to actively engage in conversation~          (assessed using a pre-visit patient survey) and actual patient behaviors in the~          encounter.~        3. Develop a coding tool that will quantify patient activation in clinical encounters.~        4. Test whether activating patients who are more involved and revealing in the~          patient-clinician dyad will improve patient and clinician outcomes.~   "
110726|NCT01606917|"~     The purpose of this study is to examine the effects of a weight reduction program in adults,~     seen in a primary care setting, with overweight/obesity perceived as a health problem or~     with diseases related to overweight/obesity and ambitions to achieve weight reduction as~     part of treatment.~   "
110727|NCT01606904|"~     The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight~     loss program affects on eating behavior, weight loss and risk factors for CHD (coronary~     heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects~     suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and~     follow how they benefit from the program in order to achieve maintained weight loss. Also,~     the associations between weight loss, physical activity and musculoskeletal disorders are~     studied.~   "
110728|NCT01606891|"~     The goal of the Minnesota center is to integrate primary care, home, and community-based~     intervention strategies to promote sustained patterns of change in food intake, physical~     activity, and body weight among low income, ethnically diverse children. A culturally~     matched family connector will create linkages among the settings to support parents in~     making home environment and parenting behavior changes conducive to healthy growth and~     development in their children.~      Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted~     randomized controlled intervention on the primary outcome, child BMI, compared to a standard~     primary care-only intervention among 500 low income ethnic minority two to four year old~     children who are at or above the 50th percentile of BMI for age and gender.~      Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower~     BMI at 24 and 36 months, compared with children in the standard primary care only control~     group.~      Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted~     intervention on secondary outcomes, including change in child energy intake and physical~     activity energy expenditure, compared to a standard primary care-only intervention.~      Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower~     energy intake and higher energy expenditure over the three-year period, compared with~     children in the standard primary care-only control group.~      Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on~     hypothesized mediators of change in dietary intake, physical activity, and BMI.~      Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and~     physical activity environment will mediate changes in child energy intake and expenditure,~     and body mass index.~   "
110729|NCT01606878|"~     This phase I trial studies the side effects and the best dose of crizotinib giving together~     with combination chemotherapy in treating younger patients with relapsed or refractory solid~     tumors or anaplastic large cell lymphoma. Crizotinib may stop the growth of tumor or cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as cyclophosphamide, topotecan hydrochloride, dexrazoxane hydrochloride, doxorubicin~     hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing~   "
110730|NCT01606865|"~     The aim of the study is to evaluate if there is an association between platelet inhibition~     and surgery-related bleeding in patients undergoing non-cardiac surgery during dual~     antiplatelet therapy.~   "
110731|NCT01606852|"~     Mechanical ventilation (MV) is the most frequently used life-support modality in intensive~     care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently~     administer a variety of sedative medications to their patients based on subjective~     observations.~      The investigators hypothesize that patient-controlled sedation, compared to~     clinician-directed sedation, will decrease sedative exposure while decreasing patient~     anxiety during the episode of mechanical ventilation.~   "
110732|NCT01606839|"~     The study hypothesis is that accuracy of CO measurement by IGR does not differ from~     classical CO measurement methods such as thermodilution or direct Fick method. This is why~     the study aims to determine whether non invasive cardiac output (CO) measurement using inert~     gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order~     to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up~     right heart catheterization.~   "
110733|NCT01606826|"~     The mission of the SARP is to improve the understanding of severe asthma through integrated~     study of its clinical and biological features and to evaluate their changes over time. The~     ultimate goal of these efforts is to promote better treatments for severe asthma.~   "
110734|NCT01606813|"~     The investigators will conduct a randomized controlled trial comparing the effects of three~     interventions on weight loss at 12 months. The investigators propose to test the impact of~     integrating an effective automated Internet weight control program into primary care by~     recruiting patients and randomizing them to one of three conditions: A) Brief physician~     counseling plus usual care, B) Brief physician counseling plus referral and access to the~     Internet weight control program and, C) Brief physician counseling plus referral and access~     to the Internet weight control program plus brief follow-up email notes of support and~     accountability from Primary Care Physicians. The investigators hypothesize that an online~     program for weight control can be more effective by enhancing online follow-up with PCPs.~   "
110735|NCT01606800|"~     The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks)~     versus standard 48 week treatment in previously untreated adult participants with chronic~     hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined~     as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.~   "
110755|NCT01606540|"~     It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is~     based only on experimental studies with animals whose results are automatically translated~     for humans. The purpose is to examine whether these drugs slow bone healing and what~     relationship there is between different bone examinations, scan for osteoporosis, bone~     marker laboratory tests, radiological controls and histology of newly formed bone under a~     microscope.~   "
110778|NCT01606241|"~     This phase I clinical trial studies the side effects of vaccine therapy and cyclophosphamide~     in treating patients with stage II-III breast cancer or stage II-IV ovarian, primary~     peritoneal or fallopian tube cancer. Vaccines made from peptides may help the body build an~     effective immune response to kill tumor cells. Drugs used in chemotherapy, such as~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving vaccine therapy and cyclophosphamide may kill more tumor cells.~   "
110736|NCT01606787|"~     The purpose of this study is to determine if a medication called mannitol, can help the~     kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in~     urine production (it is a diuretic). For many years, mannitol has been given to patients in~     the hope it would improve the kidney's circulation, and in doing so reduce the impact of the~     surgery on the kidney.~      Mannitol is given during the surgery before the blood supply to the kidney is stopped. The~     blood supply to the kidney is stopped in order to minimize any blood loss during the removal~     of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is~     removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary~     reduction in blood supply to the kidney is the loss of some kidney function. This may happen~     either in the short term (right away) or long term (months or years later). In studies done~     on animals, mannitol was able to lessen this damage to kidney function. However, no human~     study has ever confirmed that mannitol has the same helpful effect in humans. There is some~     suggestion that it may have no effect. Because sufficient research has yet to be done on~     humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan~     Kettering which looked back at patients who had undergone partial nephrectomies, an~     operation where only the portion of the kidney that contains the tumor is removed and~     enables the normal, unaffected portion of the kidney to be preserved. The results of this~     study demonstrated no significant difference in kidney function when the investigators~     compared patients who were given mannitol to those who were not. The investigators hope that~     this study will help clarify the effectiveness or not of mannitol on kidney function. During~     the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo.~     A placebo, is a harmless medication that has no effects. The impact of mannitol compared to~     the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after~     your surgery.~   "
110737|NCT01606774|"~     The investigators plan to identify 80 pregnant women at low risk for obstetrical~     complications and replace 4-5 routine third trimester visits with a structured program of~     home weight, blood pressure and urine protein monitoring along with regular structured phone~     interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is~     both safe and acceptable.~   "
110738|NCT01606761|"~     The purpose of this study is to assess the efficacy of sirukumab as measured by the~     reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA~     who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.~   "
110739|NCT01606748|"~     The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in~     combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors~     and to assess the potential for drug-drug interactions between necitumumab and~     gemcitabine-cisplatin.~   "
110740|NCT01606735|"~     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular~     inflammation after ocular surgery.~   "
110741|NCT01606722|"~     To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations~     and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.~   "
110742|NCT01606709|"~     The purpose of this study is to compare gene expression profiles in endometrial biopsies~     during the window of implantation after triggers of oocyte maturation using GnRH agonist or~     hCG and compared with their natural cycles in order to identify genes that may be~     dysregulated in GnRH agonist-triggered cycles.~      The investigators also intend to evaluate patients feeling of well being and physical~     quality of life after GnRH agonist trigger compared with hCG trigger~   "
110743|NCT01606696|"~     The purpose of this study is to compare the effect higher intensity interval exercise (HIIT)~     with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients~     with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.~   "
110744|NCT01606683|"~     The purpose of this study is the evaluation with untargeted modalities, of the urine~     metabolomic profile in a group of infants fed with a standard formula, a group of infants~     fed with a formula supplemented with functional ingredients and a group of breast-fed~     infants.~   "
110745|NCT01606670|"~     The primary objective of this study is to evaluate the perception of pain associated with~     Parkinson´s Disease in patients who receive Neupro® for the first time.~   "
110746|NCT01606657|"~     In this study, the investigators are trying to find out if washing out the abscess (pocket~     of pus) with fluid will help, instead of only taking out the pus. Your care will be the same~     as usual, except that you will be selected randomly to have your abscess washed out with~     fluid, or not.~   "
110747|NCT01606644|"~     Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue~     injury to salivary gland tissue.~   "
110748|NCT01606631|"~     The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of~     infectious diseases. They are one of the top ten causes of death in industrialized~     countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in~     their occurrence on a community infection has never been studied. The objective of this~     study is to evaluate this role.~   "
110749|NCT01606618|"~     With improved life expectancy over the last fifty years, spina bifida has become a disease~     of the adult. One of the major stakes for these patients is the preservation of a regular~     follow-up of uro-nephrologicals risk factors and of a respect for the rules of self~     management of their neurological bladder.~      The main objective of this study is to highlight a difference in the level of global~     self-esteem among a population of adult patients with spina bifida and a population of adult~     patients with traumatic spinal cord injury gained the same level of neurological.~   "
110750|NCT01606605|"~     The investigators perform a retrospective microarray gene expression profiling study of FFPE~     from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and~     Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients~     with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is~     correlated with clinical outcomes of diffuse large B-cell lymphoma.~   "
110751|NCT01606592|"~     The efficacy of two forms of psychotherapy with panic disordered patients, a~     cognitive-behavioral and a psychodynamic one, are compared under two different, randomized~     conditions: randomization or self-selection. The basic hypotheses are that the efficacy of~     both treatments is higher and that the efficacy difference is smaller under self-selection~     than randomized conditions.~   "
110752|NCT01606579|"~     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have~     advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling~     pathway that cancer cells need to grow and spread (metastasize).~   "
110753|NCT01606566|"~     The purpose of this study is to evaluate the efficacy and safety of PC-A11 with superficial~     and/or interstitial laser light application in patients with recurrent SCCHN.~   "
110754|NCT01606553|"~     The purpose of this study is to determine whether a high intensity short duration~     inspiratory muscle training is feasible, secure and effective to improve respiratory muscle~     function (strength and resistance), health-related quality of life, and to assess potential~     correlations with health resources utilization.~   "
110756|NCT01606527|"~     The proposed study is a prospective, randomized, double-blind, placebo-controlled clinical~     trial evaluating ibuprofen and placebo for the prevention of neurological forms of altitude~     illness [including high altitude headache (HAH), acute mountain sickness (AMS), high~     altitude cerebral edema (HACE), and an emerging concept of High Altitude Anxiety]. The study~     will take place in the spring and summer of 2012 at the Marine Corps Mountain Warfare~     Training Center in the Eastern Sierras near Bridgeport, California. US Marines from near sea~     level will participate in battalion-level training exercises at between 8,500-11,500 Feet,~     where some altitude illness is expected. Concurrent measures used to determine objective~     markers of altitude illness, such that validated clinical scales, rapid cognitive screening~     tests, will inform us of symptoms of altitude illness.~   "
110757|NCT01606514|"~     A single disaster, terrorist attack, or other large-scale incident can adversely affect~     thousands of youth and families. Immediate consequences may include unmet basic needs and~     high economic burden, particularly among underserved populations. Disasters also can~     dramatically affect family roles and relationships over time (e.g., family routines, marital~     stress, parent-child interactions). Whereas most youth are resilient in the aftermath of~     disasters (i.e., do not develop serious mental health or health-risk problems), the~     prevalence of various problems of public health significance (e.g., PTSD, depression,~     substance abuse) clearly increases in this population. This underscores the need for~     effective, widely accessible, culturally-appropriate and cost-efficient interventions that~     foster resilience or rapid recovery relative to the health effects of disasters. Yet, few~     evidence-informed resources are available to youth and families to facilitate post-disaster~     resilience and recovery. Primary aims of this project are: (a) to develop a Web-based~     intervention for disaster-affected adolescents and parents targeting prevalent~     health-related correlates of disasters (i.e., development phase), (b) to conduct a~     randomized controlled population-based study to examine feasibility and preliminary efficacy~     of the intervention (i.e., randomized controlled trial [RCT] phase) and cultural relevance~     (i.e., perceived applicability of the intervention to one's cultural group), and (c) to~     refine the intervention based on RCT-phase data.~   "
110758|NCT01606501|"~     The primary aim this prospective longitudinal observational outcomes study is to compare 18~     month functional outcomes and health related quality of life (HRQoL) of patients undergoing~     salvage versus amputation following severe distal tibia, ankle and/or foot fractures with~     major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL~     will be measured using well established self reported measures, including the Veterans Rand~     Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).~      Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot~     injuries with major soft tissue, bone and/or ankle articular surface loss will have similar~     functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of~     injury).~      Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that~     requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or~     (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL~     had they undergone a transtibial amputation (within 6 weeks of injury).~   "
110759|NCT01606488|"~     Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients~     greater than or equal to 65 years of age.~      This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques~     in non-demented subjects increases postoperative cognitive decline (POCD) in elderly~     subjects scheduled for hip or knee replacement.~      The investigators hypothesize that preoperative beta-amyloid plaques will predict~     postoperative cognitive decline.~   "
110760|NCT01606475|"~     The purpose of this study is to evaluate the safety and efficacy of islet transplants from~     human cadaver donors into type 1 or surgical diabetes mellitus patients who experience~     frequent acute or advanced chronic complications but do not qualify for other islet~     transplant trials. Under this protocol, patients may receive intraportal alloislet~     transplant under one of the following scenarios:~        1. islet transplant alone~        2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.~   "
110761|NCT01606462|"~     The purpose of this study is to determine whether oxytocin influences memory of social~     stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of~     oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social~     stimuli.~   "
110762|NCT01606449|"~     Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can~     achieve outcomes that afford the patient lifelong satisfaction. The published results~     obtained with this surgery may not be considered to be definitive in relation to the length~     of follow-up or patients' life expectancy. The real recurrence rates and the results of~     surgery for GERD are difficult to assess due to the lack of serial time points during the~     follow-up. Further bias may have been introduced into the analysis by a lack of appropriate~     controls. The results of surgical therapy for type II-IV HH are even more controversial~     because of the high rate of anatomical relapse and the different methods of follow-up~     adopted in reported case series.~      Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The~     investigators report on patients who were followed up after surgery at various time points~     over the course of 30 years.~   "
110763|NCT01606436|"~     This study will determine if a single dose of pomaglumetad methionil affects the electrical~     activity in the heart in people with schizophrenia. This study will also help determine how~     a single high dose of pomaglumetad methionil is tolerated by participants.~   "
110764|NCT01606423|"~     This is a study to measure the effect that various doses of LY2409021 have on blood sugar~     levels and on the amount of glucose released by the liver, when glucagon is given to~     increase these. Each participant may receive up to 2 single doses of LY2409021 in 2~     different study periods, with a minimum 13-day washout between dosing periods. This study is~     approximately 9 weeks long, not including screening. A screening appointment is required~     within 6 weeks prior to the start of the study.~   "
110779|NCT01606228|"~     The purpose of this study is to explore the tolerability, safety and efficacy of flexibly~     dosed paliperidone extended release (ER) among patients with schizophrenia.~   "
111235|NCT01600287|"~     The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of~     IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual~     control using bispectral index in paediatric patients undergoing open heart surgery under~     cardio-pulmonary bypass.~   "
110765|NCT01606410|"~     Rationale: Ischaemic preconditioning (IP) refers to the reduction of ischemia-reperfusion~     injury induced by a brief preceding period of ischemia. Also the arterial endothelium can be~     protected by IP. Several studies performed in animals and humans have demonstrated that the~     protective effects of IP are attenuated with aging. However, no previous study directly~     examined the underlying mechanisms of this observation. Possibly, the reduced protective~     effect of IP with aging relates to a direct effect on the endothelium, consequently leading~     to an attenuated ability of IP to prevent endothelial dysfunction after ischaemia~     reperfusion injury.~      Several previous studies failed to demonstrate the ability of pharmacological stimuli to~     mimic the beneficial effects of IP in aged vessels. Restoration of the age-related reduction~     in effectiveness of IP may be possible through exercise training. In aged animals, physical~     training restores the efficacy of ischemic preconditioning. Indirect evidence indicates that~     physical activity, independent of other cardiovascular risk factors, protects against a~     occurrence as well as the severity of a myocardial infarction in humans. Although this~     suggests that physical activity may beneficially influence the age-related reduction in IP,~     no previous study provided direct evidence for this hypothesis.~      Objective: To examine the impact of age and physical fitness on the ability of ischaemic~     preconditioning to protect endothelial damage in response to ischaemia reperfusion injury in~     healthy humans. A secondary objective is to explore the role of Toll-like receptor (TLR)~     signalling in the induction of IP in young and old subjects.~   "
110766|NCT01606397|"~     The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The~     primary purpose of this study is to help answer the following research questions, and not to~     provide treatment for diabetes :~        -  The safety of LY2409021 and any side effects that might be associated with it following~          4 weeks of doses~        -  How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks~        -  How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and~          other naturally occurring substances before and after a meal~        -  How LY2409021 works when given with metformin~        -  How daily dosing of LY2409021 affects the cells that produce insulin~   "
110767|NCT01606384|"~     Primary Objective:~      - To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on~     hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.~      Secondary Objectives:~        -  To evaluate the tolerability and safety of SSR149415 in patients with major depressive~          disorder.~        -  To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in~          patients with major depressive disorder.~        -  To evaluate plasma concentrations of SSR149415.~   "
110768|NCT01606371|"~     The main purpose of this study is to determine the safety of LY2409021 in healthy~     participants and participants with diabetes. The study drug is given as single oral doses.~     Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing~     periods. Side effects will be documented. This study is approximately 9 weeks long, not~     including screening. Screening is required within 6 weeks prior to the start of the study.~   "
110769|NCT01606358|"~     In patients with an ovarian cancer, the treatment is currently based on surgery and~     chemotherapy.~      The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T~     cells has never been evaluated.~      The long term goal is to give a rational to combine conventional treatment of ovarian cancer~     with immunotherapy based on Vgamma9Vdelta2 T cells.~   "
110770|NCT01606345|"~     The purpose of this study is to learn more about how well the drug valrubicin (VALSTAR®)~     works to help treat the patient's cancer when administered through a nephrostomy tube~     inserted through their back into their kidney. The study is also being done to determine how~     safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in~     which the drug is eliminated from the human body (Pharmacokinetics or PK).~   "
110771|NCT01606332|"~     In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a~     postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing~     shoulder pain and improving range of motion compared to a single-dose interscalene block.~   "
110772|NCT01606319|"~     The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary~     hypothesis that in preschool children 12-59 months of age with persistent asthma on~     standardized asthma therapy, the number of asthma exacerbations requiring systemic~     corticosteroids will be more frequent in children randomized to receive acetaminophen as~     compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.~   "
110773|NCT01606306|"~     The INFANT study will test whether, in preschool children 12-59 months of age with~     persistent asthma, the following Step 2 asthma therapies will provide similar degrees of~     asthma control:~        1. Daily inhaled corticosteroid (ICS) treatment,~        2. Daily leukotriene receptor antagonist (LTRA) treatment, and~        3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.~   "
110774|NCT01606293|"~     Objectives:~      Primary: 1. To assess the feasibility of using social networking groups to survey patients~     with rare cancers.~      Secondary:1. To elucidate the current means for diagnosis and treatment of women with small~     and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis,~     treatment, and recurrence among women with small and large cell carcinomas of the cervix.~   "
110775|NCT01606280|"~     This study examines the value of stem cell transplantation in managing light chain~     amyloidisis.~   "
110776|NCT01606267|"~     The purpose of this study is to to measure the effect of the HEP+ICCM program relative to~     routine HEP approach in rural Ethiopia on changes in coverage of case management of common~     childhood illnesses and severe acute malnutrition, reductions in mortality among children~     under the age of five, and improvements in nutritional status using a rigorous evaluation~     design.~   "
110777|NCT01606254|"~     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in~     participants with schizophrenia (psychiatric disorder with symptoms of emotional~     instability, detachment from reality, often with delusions and hallucinations, and~     withdrawal into the self).~   "
110793|NCT01606046|"~     The purpose of this study is to compare the effects of vapocoolant spray and topical~     lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle~     electromyography.~   "
110780|NCT01606215|"~     This is a randomised, double-blind crossover study to study the effect of intravenous~     treatment with autologous (derived from the individuals themselves) mesenchymal stem cells~     (MSCs)in patients with multiple sclerosis (MS).~      Current treatments for MS target the immune system and are not curative. There is much~     interest in MSCs as they have the potential to not only affect the immune system but may~     also promote repair. This study will use MSCs that are harvested from the bone marrow and~     grown for up to 52 days before being given back to the person from whom they were harvested.~     This avoids any chemotherapy so is therefore safer than other types of stem cells. In this~     crossover study, everyone will receive their own stem cells back but in half it will be~     delayed by 24 weeks.~      The primary outcomes are to check that the procedure is safe and to measure any changes on~     the MRI at 24 weeks. Other more exploratory measures will try to assess effects on repair in~     the central nervous system (CNS).~   "
110781|NCT01606202|"~     A study to investigate the effects of sublingual cannabis based medicine extracts on~     neuropathic pain associated with spinal cord injury.~   "
110782|NCT01606189|"~     A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with~     placebo in the treatment of chronic pain due to brachial plexus injury.~   "
110783|NCT01606176|"~     To investigate the ability of a cannabis based medicine extract to relieve chronic~     refractory pain of neurological origin.~   "
110784|NCT01606163|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male~     adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous~     injection.~   "
110785|NCT01606150|"~     The purpose of this study is to compare two medications used to numb an infant's back when~     performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain~     cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's~     vertebrae. In the past, doctors did not know if newborns could feel the pain from a~     procedure like this in the same way that adults do. Investigators now know that the newborns~     do experience pain during this procedure, but we do not know the best way to control this~     pain. Investigators also think that when the newborns have pain, they move during the test.~     The movement can increase the chance of having blood mix with this normally clear fluid~     leading to limitations in our clinical application of these results. This study will compare~     the injected and topical forms of Lidocaine to see which gives us better pain control and~     more clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its~     deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the~     rate of clinically useful results and pain scores. The investigators hypothesize that both~     forms of Lidocaine will be 25% superior to our historical control cohort in the rate of~     clinically useful results.~   "
110786|NCT01606137|"~     Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it~     in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.~   "
110787|NCT01606124|"~     This phase II trial studies how well Polyphenon E works in treating patients with high-risk~     of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal~     cancer.~   "
110788|NCT01606111|"~     The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on~     therapy to standard care in patients with acute traumatic brain injury (TBI). The study~     duration for each patient is 180 days.~   "
110789|NCT01606098|"~     The clinical benefit of resection of the primary tumour in patients with synchronous~     unresectable metastases is not known. In the literature studies usually describe~     retrospective selected patients with synchronous metastases treated with or without~     resection of the primary tumour. All these studies are biased in patient selection and there~     are no prospective randomized studies on this topic. In patients with few or absent symptoms~     of the primary tumour, arguments both in favour and against initial resection have been~     presented, and therefore a randomized trial is warranted. Although recent publications~     suggest that resection of the primary tumour in synchronous metastasized colon cancer~     patients might not be necessary, this appears to be based on feasibility and not on clinical~     outcome. Several studies comparing large groups of patients with or without resection of the~     primary tumour suggest an improved survival when the primary tumour is resected. A potential~     benefit of resection of the primary tumour is to prevent complications of the primary tumour~     during chemotherapy treatment or during later stages of the disease. A recent analysis of~     the CAIRO and CAIRO2 data showed that metastatic colon cancer patients who had a resection~     of the primary tumour prior to study entry, had an improved survival compared to patients~     without a resection of the primary tumour. However, these patients were selected after the~     primary tumour was resected and therefore these results are not corrected for surgical~     morbidity and mortality. The investigators here propose a randomized trial in order to~     demonstrate that resection of the primary tumour does improve overall survival.~   "
110790|NCT01606085|"~     The purposes of this study are:~        1. to develop and test an integrated self care intervention for Heart Failure (HF)patients~          with Diabetes (DM) for its effects on patient outcomes including health related quality~          of life (HRQOL), physical function and health resource utilization.~        2. to assess the costs and cost effectiveness of the intervention.~      The intervention is designed to go beyond usual care of providing separate Heart Failure~     (HF) and Diabetes (DM) patient education by educating HF-DM patients on integrated self care~     and self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical~     activity, and HF-DM symptom monitoring and management. An integrated self care intervention~     will compare HF-DM patients who receive the intervention with those who receive usual~     care-attention control for effects on patient outcomes,self care process measures, and~     health care utilization. If effective, the intervention will lead to improved self care,~     improved quality of life, and reduced health care resource use and costs. This study will~     facilitate greater understanding of self care within the context of two chronic illnesses~     and will lead directly to improved clinical practice and future research on comorbid self~     care in Heart Failure.~   "
110791|NCT01606072|"~     The propose for this study is to evaluate the safety and tolerability of desmopressin when~     administered perioperatively to patients with breast cancer undergoing surgery as first~     treatment, and select the optimum dose for the clinical development of the product.~   "
110792|NCT01606059|"~     The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920~     in healthy male volunteers under fasting condition.~   "
110799|NCT01605968|"~     Study objective:~      The objective of this study is to evaluate through clinical criteria the clinical efficacy~     and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as~     effective and safe as Aquacel® Ag. Dressing.~      Study devices:~        -  Study device: BCT Silver Bandage~        -  Comparator device:ConvaTecAquacel® Ag Hydrofiber Dressing~      Study design:~        -  Randomized, Open-label, interventional, comparative, preventive study with Blinded~          evaluator.~        -  All subjects must meet all the inclusion & exclusion criteria to enter this study in~          pre-operative phase.~        -  Eligible subjects will be enrolled after a scheduled operative procedure.~        -  There is SEVEN visits in this study (one screening eligibility phase up to 7 days~          before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day,~          5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.~        -  During each scheduled visit, each subject will have colored picture of his wound after~          dressing been removed, and on visit V6 for wound evaluation by blinded PI.~      Number of subjects: It is expected to recruit ≧150 eligible subjects.~      Study Duration: About eighteen month.~   "
110800|NCT01605955|"~     The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in~     comparison to gold-standard measurements of blood SaO2 by a CO-oximeter~   "
110801|NCT01605942|"~     This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior~     segment inflammation and pain following cataract extraction with lens implantation.~   "
110802|NCT01605929|"~     The primary objective of this prospective, descriptive study is to evaluate the success rate~     of the retroclavicular brachial plexus block and catheter placement in 60 adult patients~     undergoing hand, wrist, or forearm surgery. The investigators will also evaluate any~     difficulties performing the procedure, the onset time and distribution of the block,~     incidence of adverse events, and patient's acceptance of the block.~   "
110803|NCT01605916|"~     The objective of this study will be to investigate the safety and tolerability of AZD6244~     given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients~     with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung~     Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following~     the combination regimen dose escalation phase (Part A) of the study additional patients may~     be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability,~     pharmacokinetics and biological activity of the combination in this patient population.~   "
110804|NCT01605903|"~     Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in~     children. One risk of tonsillectomy is postoperative bleeding, and this can be more~     dangerous in children because their blood volume is lower than adults. Ibuprofen, a~     nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent~     guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen~     after tonsillectomy. However, NSAIDs are associated with altered platelet function and a~     theoretical increased risk of bleeding after surgery. The investigators would like to~     explore the effect that ibuprofen has on postoperative bleeding, as well as validate~     previous studies demonstrating it is an effective pain medication after tonsillectomy.~   "
110805|NCT01605890|"~     The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same~     sensibility to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are~     appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy~     including PI is less effective for HIV-2. Also, the choice of ARTs in a second line~     treatment is limited. The first line optimal treatment has to be defined by a prospective~     and randomized evaluation of other strategies. The primary endpoint will be adapted to the~     specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical~     trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to~     the classical triple therapy, shows an immunovirological response, at least, as good as the~     one obtained with the triple therapy. The hypothesis is that the low ART response observed~     in HIV-2 infection is due to a low virological strength of the ARTs used and that the~     combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at~     week 48.~   "
110806|NCT01605877|"~     The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR®~     +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.~   "
110807|NCT01605864|"~     Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection~     in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to~     be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics~     together. These antibiotics usually include a cephalosporin and a macrolide. The most~     commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most~     commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.~      This research is being done to find out how well a new cephalosporin antibiotic, called~     ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is~     similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in~     hospitalized patients based on two research studies. In one study, ceftaroline was better~     than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone.~     Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe~     as ceftriaxone.~   "
110808|NCT01605851|"~     The primary objective of this study is to evaluate clinical success and performance of the~     GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen~     Ovale (PFO).~   "
110831|NCT01605552|"~     The objective of this clinical trial is to evaluate whether a computerized depression~     treatment, delivered before the onset of heart disease, reduces the risk of heart disease in~     the future. Participants in this trial will be primary care patients who are depressed but~     do not have a history of heart disease. Half of these patients will receive a standard~     treatment (usual care), and the other half will receive eight weeks of an evidence-based~     psychological treatment called Beating the Blues®, which is a computerized, cognitive~     behavioral treatment program for depression. To evaluate change in heart disease risk, the~     investigators will measure the functioning of the arteries using ultrasound before and after~     the treatment. It is hypothesized that patients who receive Beating the Blues® will show~     greater improvements in both depression and artery function than patients who receive~     standard treatment.~   "
110809|NCT01605838|"~     BACKGROUND: The brain is very sensitive to both excessive and insufficient flow of blood.~     Cerebral blood flow (CBF) is normally auto-regulated by the blood vessels in the brain, but~     this protective mechanism is often disturbed after a traumatic brain injury (TBI).~     Impairment or loss of the CBF autoregulation makes the brain vulnerable to oscillations of~     either arterial blood pressure (ABP) or intracranial pressure (ICP). The ideal management of~     TBI patients, therefore, involves continuous measurement and management of the cerebral~     perfusion pressure (CPP = ABP - ICP) but the measurement of CPP is currently possible only~     with specialized equipment and expertise that is not available in all institutions. The~     investigators have converted a no-longer used system that continuously monitors CBF~     autoregulation using rheoencephalography (REG) technology into a modern, small,~     battery-powered, low-cost monitor (aka BM-1) that acquires the REG signals using only~     noninvasive electrodes placed on the skin/scalp. REG data can then be used to calculate the~     optimal CPP to maintain in each individual patient. BM-1 is also capable of monitoring~     electroencephalography (EEG) and impedance plethysmography (IPG), which can, respectively,~     be used to measure brain electrical activity and changes in peripheral blood flow caused by~     blood pressure changes.~      OBJECTIVES: The primary objectives are to (Obj. 1) demonstrate that REG acquired~     noninvasively is equal to the well-established but invasive method using intracranial~     pressure (ICP) monitoring, (Obj. 2) retrospectively test the idea that TBI patients have a~     less favorable outcome if their CPP were found less optimal using the REG data, and (Obj. 3)~     determine if noninvasive IPG or the PPG finger sensor monitoring (used to measure heart rate~     in doctor's offices) can replace the invasive monitoring of arterial blood pressure (ABP).~      METHODOLOGY: This is an observational study with retrospective data analysis. 20 adult~     patients (18-65 yrs) with acute TBI, who meet the inclusion/exclusion criteria, will be~     enrolled on a first-come-first-enroll basis. The enrolled patients will have the REG, EEG~     and IPG signals monitored for the duration of ICU stay or 15 days, whichever is shorter.~     Standard neurological assessment will be made at the patient's discharge from the ICU and at~     3 months after injury. The study is expected to end June 2013.~   "
110810|NCT01605825|"~     This is a multi-center, safety and tolerability study in subjects with chronic stable~     sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,~     placebo-controlled, 2-period crossover study.~   "
110811|NCT01605812|"~     In this study, the investigators examined the capsule-IOL interaction including anterior and~     posterior capsule adhesion, contact between posterior capsule and the posterior edge of~     intraocular lense (IOL), configuration of capsular bend and the incidence of posterior~     capsular opacity (PCO) between high myopia eyes and emmetropia eyes.~   "
110812|NCT01605799|"~     The goals of this project are~        -  1) to evaluate the effectiveness of a CBT treatment module addressing the mental health~          and functional impact of killing in the war zone,~        -  2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility~          of the CBT treatment module, which would be used to further refine the intervention,~          and~        -  3) to gather data on clinician stakeholders' perceptions of acceptability and~          feasibility of the CBT treatment module, which would be used to ensure that the module~          could be easily integrated into EBT for PTSD.~   "
110813|NCT01605786|"~     This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a~     synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and~     immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and~     efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an~     artificial malaria challenge using Pf sporozoites in a healthy adult population.~   "
110814|NCT01605773|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.~   "
110815|NCT01605760|"~     The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens~     in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house~     dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic~     rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin~     prick tests, serum-specific IgE and nasal provocation tests were included. Patients were~     individually randomised to groups: active or placebo using a double-blind method. A total of~     51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R,~     Stallergens, France) and 57 in the placebo group were monitored for three years. The~     patients had to record on a diary card whenever they used anti-allergic medications.~   "
110816|NCT01605747|"~     The primary objective of this study is to determine if probiotic prophylaxis has immunologic~     and gastrointestinal advantages in pediatric burn patients.~   "
110817|NCT01605734|"~     TACE is widely used in patients with unresectable HCC. However, it is a non-curative~     approach; thus ,strategies to further improve the survival of these patients are needed.~     Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic~     therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that~     the combination of TACE with sorafenib could improve the survival of patients with~     unresectable HCC.~   "
110818|NCT01605721|"~     Objectives:~        1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE~          PRIMETM in a cohort of real world patients and lesion subsets.~        2. To determine clinical device and procedural success during commercial use of XIENCE~          PRIMETM coronary stent~      Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM~      Study period~        -  Patient enrollment: 2011.05 ~ 2012.04~        -  End of follow-up period: 2015. 02 (3 years of follow-up)~      Primary endpoint~      : Target Lesion Failure (TLF) rate at 12 months~      Secondary endpoint:~        -  In-stent & In-segment Late Loss at 9 months~        -  Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3~          years (very late)~        -  Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)~        -  Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years~        -  Composite rate of cardiac death and any MI up to 3 years~        -  Composite rate of all death and any MI up to 3 years~        -  Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat~          revascularization up to 3 years~        -  Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up~          to 3 years~        -  Procedural success up to 1 day~        -  Angiographic success up to 1 day~   "
110819|NCT01605708|"~     The purpose of this study is to assess the clinical activity on refractory~     moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients~     with moderate-to-severe atopic dermatitis (AD).~   "
110820|NCT01605695|"~     The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are~     developing the sepsis pathology has provided an opportunity to develop a first-in-class~     diagnostic test for the onset of sepsis. This study is designed to determine the normal~     human plasma level of circulating iNOS as the initial reference level against which~     hospitalized patients at risk for the development of sepsis can be compared to ascertain if~     the patient is at risk for becoming septic based upon an elevated level of plasma iNOS.~   "
110821|NCT01605682|"~     Berry fruits are widely recognised as natural functional food products. They contain several~     different phytochemicals which have potential to modulate human health and wellbeing. There~     is however some debate regarding the mechanisms driving their health promoting properties.~      Despite the wide health promoting properties of fruit extracts reported in the literature,~     considerable interest over the past decade has primarily been focused on their roles in~     reducing risk factors associated with cancer and heart disease. Consequently, there remains~     a paucity of actual scientific information on their role in modulating brain functions, such~     as mood, learning and memory, any decrements of which have very negative impacts on the~     quality of life.~      A prior study carried out as the first study of my PhD, attempted to bridge this gap in~     knowledge and found promising results after acutely supplementing participants with a fruit~     based drink. The findings showed that there was an increased vigilance on attention related~     psychometric tasks and an increased feeling of calmness. The investigators have hypothesised~     that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting~     effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B~     activity.~      The aims of the current study are threefold: to extend the findings of my previous~     investigation by extending the tasks explored; to ascertain if the positive results of the~     first study are dose dependent; and to investigate whether a lower dose can facilitate~     greater changes in behaviour.~   "
110822|NCT01605669|"~     According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with~     asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE)~     performed annually for severe disease, every 1-2 years for moderate disease and every 3-5~     years for mild disease. This results in a multitude of screening studies in the~     investigators patient population. 3M has developed a new stethoscope and phonocardiography~     software capable of identifying the peak intensity of the AS murmur and tracking it as it~     moves towards the second heart sound potentially indicating increasing severity of disease.~     Currently there exists no data to demonstrate that the aortic stenosis acceleration index~     (ASAI) correlates to disease severity or progression of disease. The ASAI measures the~     timing of the peak intensity of the systolic murmur and compares it to the total time in~     systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x~     with the time between S1 and the peak intensity of the murmur. In this study the~     investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis~     severity.~   "
110823|NCT01605656|"~     The goal of this study is to better understand the factors that might prevent HIV-positive~     women from having routine pap smear screenings. Researchers also want to learn what might~     make it easier or encourage women to have these screenings.~   "
110824|NCT01605643|"~     Use of tobacco is very high among Alaska Native women. The investigators are conducting a~     three phase study. The first phase will examine biomarkers of tobacco exposure in pregnant~     women and their newborns. The second phase is a qualitative study to translate the biomarker~     findings into intervention messages. The third phase is a pilot of the biomarker feedback~     intervention compared with a control condition.~   "
110825|NCT01605630|"~     The no show rate for mammography screening is high among Navajo women. One barrier to~     preventive screening is a lack of cancer literacy including low knowledge and cultural~     attitudes (e.g., fatalism) about screening. The investigators will examine the potential~     feasibility and acceptability of a cancer literacy intervention for families of Navajo women~     who have no showed for three consecutive times to mammography screening who have never or~     rarely been screened in the past.~   "
110826|NCT01605617|"~     The investigators are studying two FDA-approved modalities used to treat overactive bladder~     to determine if they improve overactive bladder with or without urge incontinence when used~     together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS~     and fesoterodine fumarate.~   "
110827|NCT01605604|"~     The pupose of the study is to determine the effectiveness of the Buddhist integrated group~     intervention improve the mindfulness in adolescents by a randomized controlled trial.The~     study divede the adolescents in two groups group A recieved the 8 time Buddhist group~     interventions.Group recieved nothing.The measurement were done pre and post intervention at~     week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both~     groups.~   "
110828|NCT01605591|"~     The purpose of this study is to comparing the effects of different double-lumen endotracheal~     tube's bending type in tracheal intubation.~   "
110829|NCT01605578|"~     The purpose of this study is to compare, in healthy women, the adipose tissue composition~     between abdomen and thigh and then determine whether differences exist independently of the~     state of obesity.~      The findings of this study may help to explain the mechanism contributing to a beneficial~     role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on~     cardiovascular and metabolic dysfunctions.~   "
110830|NCT01605565|"~     Cystic fibrosis (CF) is characterized by airway inflammation and infection leading to~     progressive destruction of lungs. One of the most important abnormalities in CF is an~     abnormal processing of the mutated CFTR protein through the endoplasmic reticulum that~     causes abnormal location or even absence of the protein at the apical plasma membrane of~     airway epithelial cells. This abnormality results in a marked dehydration of the airway~     surface fluid, decreased mucus transport and airway obstruction. Nevertheless, the events~     that occur very early during the progression of the disease at the airway level in infants~     are not known. At cellular level, it has also been reported that the CFTR expression and~     localization could be related to the differentiation state of the airway epithelium.~     Furthermore, it has been reported that gap junctions could be involved in dysregulate~     inflammation process. In CF infants, many answers are still lacking. For a better~     understanding of the early stages of cystic fibrosis, it is of major interest to study~     respiratory epithelial cells obtained as early as possible. In 15 CF infants and 15 control~     infants, a nasal brushing will be performed by means of a soft sterile cytology brush.~     Samples will be used for cytological and functional studies: ciliary beating frequency,~     cAMP-dependent chloride efflux, potassium efflux, tight and gap junctions functionalities.~     These studies will be done in basal conditions and will be repeated after activation of the~     nasal epithelial cells by the bacteria, such as Staphylococcus aureus, which can be found~     very early in the course of CF disease.~   "
145706|NCT01147341|"~     Purpose of the study is to determine if Cimzia is safe and effective in subjects who have~     received previous treatment with a TNF-alpha inhibitor other than Cimzia.~   "
110832|NCT01605539|"~     Despite the current available therapies for opioid-dependent patients, most patients~     relapse. This research project focuses on the development of a novel compound, cannabidiol,~     to modulate opioid craving in humans based on animal models showing its selective~     effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for~     opioid relapse would be of tremendous medical and public health value.~   "
110833|NCT01605526|"~     This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and~     efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma.~     Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of~     each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each~     cycle for up to 6 cycles.~   "
110834|NCT01605513|"~     The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective~     in the treatment of HCV patients.~   "
110835|NCT01605500|"~     The purpose of this study is to determine whether the alert tones emitted by the latest~     generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to~     patients.~      ICD patients can have difficulties hearing the beeps, which are designed to notify patients~     of possible lead or generator malfunction. In fact, the only published study of this issue,~     conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with~     older Medtronic devices were able to hear alerts. Since then, modifications to the alert~     have been made by Medtronic. This study will establish the real-world value of these~     changes and also provide useful in vivo information regarding the validity of the in vitro~     techniques which have been used thus far to design the Patient Alert feature.~   "
110836|NCT01605487|"~     Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg~     doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier~     element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany)~     will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C~     simultaneously in a standardized and reproducible way and thus the determination of~     individual temperature and/or stimulation time thresholds.~      In addition mediators related from activated must cells such as histamine, PAF, PGD2 should~     be identified in the period between the application of stimulus and the appearance of~     symptoms of cold urticaria and should be characterized qualitatively and quantitatively.~   "
110837|NCT01605474|"~     This study examines whether outpatient pre-induction cervical ripening improves patient~     satisfaction and is safe and effective.~   "
110838|NCT01605461|"~     Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose~     of [14C]-BI 207127 and to characterize the metabolic profile following single dose~     administration.~   "
110839|NCT01605448|"~     The investigators are investigating the benefits of a mind/body intervention, Mindfulness~     Based Stress Reduction, for adults with Mild Cognitive Impairment.~   "
110840|NCT01605435|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in~     the brain. The purpose of this study is to determine the optimal subcutaneous ghrelin dose~     as a potential intervention for frail elderly individuals. We will examine food intake and~     metabolic parameters after placebo and ghrelin administration at three escalating~     subcutaneously administered doses.~   "
110841|NCT01605422|"~     Dietary pulses (beans, peas, chickpeas, and lentils), more commonly known as legumes, are~     generally recognized as healthy components of the diet. Canada's Food Guide encourages~     consumptions of meat alternatives, such as beans more often; and the dietary guidelines~     for Americans both recommend consumption of 3 cups of legumes per week. However, there~     remains insufficient information on the usefulness of these foods in protecting heart~     health. To improve evidence-based guidance for dietary pulse recommendations, the~     investigators propose to conduct a systematic review of the effect of dietary pulse~     consumption on after-meal blood sugar levels, appetite, and food intake regulation to help~     explain their mechanism for improving longterm blood sugar and body weight control. The~     systematic review process allows the combining of the results from many small studies in~     order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The~     investigators will be able to explore whether eating pulses has different effects between~     men and women, in different age groups and background disease states, and whether or not the~     effect of pulses depends on the dose and background diet. The findings of this proposed~     knowledge synthesis will help improve the health of Canadians through informing~     recommendations for the general public, as well as those at risk of heart disease and~     diabetes.~   "
110842|NCT01605409|"~     Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation~     algorithms and postcardiac arrest care have been improved there is an urgent need for~     measures leading to a higher survival rate.~      Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients~     body) is a method which has shown good results in case reports and animal studies for~     cardiac arrest care.~      The study will be performed as comparison between the new treatment option of ECPB versus~     the standard of care treatment.~      Aim of our study is to determine the feasibility of ECPB installed in an emergency~     department to improve the rate of patients restoration of spontaneous circulation.~   "
110843|NCT01605396|"~     The purpose of the study is to evaluate the progression free survival (PFS) of~     ridaforolimus, dalotuzumab and exemestane (R/D/E) compared to the combination of~     ridaforolimus and exemestane (R/E) in post-menopausal participants with breast cancer.~   "
110844|NCT01605383|"~     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the~     femoral head in comparison to the standard treatment of isolated core decompression.~      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded~     autologous mesenchymal stem cells fixed in allogenic bone tissue.~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration, avoiding the progression to collapse of the femoral head.~   "
110845|NCT01605370|"~     The purpose of this study is to evaluate if a drug called nebivolol can reverse~     inappropriate left ventricular mass (LVM) when compared to the standard of care drug~     metoprolol.~   "
145707|NCT01147328|"~     The purpose of this study is to assess usage of the virtual health record (VHR), and~     determine the effects of this technology on healthcare utilization.~   "
110846|NCT01605357|"~     Cerebral edema is seen heterogenous group of neurological disease states that mainly fall~     under the categories of metabolic, infectious, neoplasia, cerebrovascular, and traumatic~     brain injury disease states. Regardless of the driving force, cerebral edema is defined as~     the accumulation of fluid in the brain's intracellular and extracellular spaces. This occurs~     secondary to alterations in the complex interplay between four distinct fluid compartments~     within the cranium. In any human cranium; fluid is contained in the blood, the cerebrospinal~     fluid, interstitial fluid of the brain parenchyma, and the intracellular fluid of the~     neurons and glia. Fluid movement occurs normally between these compartments and depends on~     specific concentrations of solutes (such as sodium) and water. In brain-injured states, the~     normal regulation of this process is disturbed and cerebral edema can develop. Cerebral~     edema leads to increased intracranial pressure and mortality secondary to brain tissue~     compression, given the confines of the fixed-volume cranium. Additionally, secondary~     neuronal dysfunction or death can occur at the cellular level secondary to the disruption of~     ion gradients that control metabolism and function.~      While studies utilizing bolus dosing of hyperosmolar therapy to target signs or symptoms of~     increased intracranial pressure secondary to cerebral edema are numerous, there is a paucity~     of studies relating to continuous infusion of hyperosmolar therapy for targeted sustained~     hypernatremia for the prevention and treatment of cerebral edema. The investigators~     hypothesize that induced, sustained hypernatremia following traumatic brain injury will~     decrease the rate of cerebral edema formation and improve patient outcomes.~   "
110847|NCT01605344|"~     The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic~     profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in~     combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination~     with atorvastatin.~   "
110848|NCT01605331|"~     As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH~     deficiency has been known to improve metabolic impairment and quality of life. Patients,~     however, do have to tolerate daily injections of GH (rhGH).~   "
110849|NCT01605318|"~     This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles,~     once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with~     metastatic colorectal cancer who have been previously treated with at least one prior~     irinotecan-containing regimen. The study is being done to evaluate whether the study drug is~     safe and tolerable at different dose levels with these dosing schedules and to obtain~     preliminary information on its efficacy.~   "
110850|NCT01605305|"~     The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to~     progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic~     esophagus.~   "
110851|NCT01605292|"~     Radial artery access for cardiac catheterization can require multiple attempts. Multiple~     attempts increase the time required, patient discomfort, and the risk of arterial spasm.~     Ultrasound guidance has been shown in other studies to reduce the number of attempts and~     complications in central venous and femoral artery access. This study will test if the~     addition of ultrasound guidance reduces the number of attempts and time required to access~     the radial artery.~   "
110852|NCT01605279|"~     Low systemic flow as measured by Doppler-echocardiography has been associated with poor~     neurological outcome. Yet, it has not been systematically evaluated whether the treatment of~     this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low~     systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation~     and in newborn prognosis.~   "
110853|NCT01605266|"~     INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic,~     serologic and environmental factors contributing to nephrotic syndrome and disease~     progression.~   "
110854|NCT01605253|"~     The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is~     effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep~     disturbance. The investigators will also examine the impact of treatment on sleep patterns,~     memory recall bias, and level of inflammatory markers (cytokines). The investigators predict~     eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,~     memory recall bias, and level of inflammatory markers.~   "
110855|NCT01605240|"~     For simple fractures treated in the emergency department with cast immobilisation only,~     ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less~     side effects. These and other studies have commented that their results may not be~     applicable to children who have fractures that require reduction. There is currently no~     literature on the management of postoperative pain following reduction of paediatric~     fractures. The investigators aim therefore is to investigate whether either of the two most~     commonly prescribed analgesics is superior to the other for postoperative pain management~     following closed reductions of paediatric forearm fractures. Also, if one agent has more~     side effects than the other.~   "
110856|NCT01605227|"~     This study will evaluate the effect of cabozantinib compared to prednisone on overall~     survival in men with previously treated metastatic castration-resistant prostate cancer with~     bone-dominant disease who have experienced disease progression on docetaxel-containing~     chemotherapy and abiraterone or MDV3100.~   "
110868|NCT01605071|"~     The aim of the current study is to test whether the effect of estrogen on insulin metabolism~     depends on the timing of treatment relative to when a woman went through menopause. The~     investigators hypothesize that estrogen will improve insulin sensitivity in early~     postmenopausal women, but decrease insulin sensitivity in late postmenopausal women.~   "
110869|NCT01605058|"~     The purpose of this study is to evaluate the visual performance of a trifocal intraocular~     lens at distance, near and intermediate viewing, by way of visual acuity measurement,~     contrast sensitivity.~      Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.~   "
110870|NCT01605045|"~     The aim of this study is to evaluate the effects of screening using the fluoroscopy-save~     function on reduction of radiation exposure and quality of angiogram during cardiac~     catheterization when compared to traditional cinematography-guided coronary angiography.~   "
110913|NCT01604668|"~     There is no study hypothesis. The purpose of this study is to compare the accuracy of the:~     1) SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the~     SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently~     marketed version) in patients undergoing spine surgery.~   "
110857|NCT01605214|"~     Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality~     following lung transplant and is characterized by acute lung injury and capillary leak~     leading to an increase in extravascular lung water index (ELWI) and impaired graft function.~     PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be~     life-threatening and can also lead to impaired long term lung function. In ARDS, a~     restrictive fluid strategy has been associated with an improvement in lung function and~     outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid~     management and limiting the extent of ELWI that accumulates in the setting of PGD are~     lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability~     index (PPI) represents a novel approach to fluid management, which has been used in patients~     with ARDS, but to date not in the transplant setting. To determine if these measurements may~     better guide the management of lung transplant patients, the investigators first wish to~     establish whether these methods are able to predict the onset of clinical pulmonary edema~     earlier, whether they correlated with traditional markers of PGD, and whether they may be~     useful for predicting outcomes.~      AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates~     of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction~     (PGD)~      AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence~     and severity of PGD.~      AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can~     predict the onset of PGD.~      b) Across different strata of PGD, the investigators will determine whether ELWI and PPI~     have a differential effect on duration of mechanical ventilation.~      The results of the study will be used for the following:~        1. Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more~          discriminatory and have a stronger association with outcome compared to the current~          gold standard.~        2. Provide the means of early identification of those as risk of developing PGD in order~          to guide management decisions or future therapeutic interventions aimed at preventing~          or treating PGD.~        3. Provide the requisite groundwork for a clinical trial comparing the effects of an~          ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.~   "
110858|NCT01605201|"~     The purpose of this study is to investigate the safety and feasibility of implanting an~     engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes~     within a collagen type I/III membrane into the cartilage defect on the femoral condyle~     and/or trochlea of the knee after a traumatic injury.~   "
110859|NCT01605188|"~     The aim of our study is to prospectively identify, at diagnosis, factors predictive of~     non-response or loss of response in patients with inflammatory bowel disease treated with~     anti-TNF.~   "
110860|NCT01605175|"~     The aim of this study is to prospectively identify, at diagnosis of the disease, factors~     predictive of mucosal healing in patients with inflammatory bowel disease treated with~     anti-TNF.~   "
110861|NCT01605162|"~     This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the~     selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ)~     in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease~     progression. Eligible subjects must have measurable disease according to Response Evaluation~     Criteria in Solid Tumors (RECIST).~   "
110862|NCT01605149|"~     Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is~     unclear how and when it effects the bone density. The investigators are studying the effects~     of diabetes on bone mass compared to children without diabetes.~   "
110863|NCT01605136|"~     This is a randomized placebo-controlled study to be conducted in two parallel study arms for~     a six month period (three doses). Between 75 and 100 eligible patients will be enrolled.~     Patients will receive afamelanotide (16 mg implants) or placebo according to the following~     dosing regimen:~        -  Group A will be administered afamelanotide implants on Days 0, 60 and 120~        -  Group B will be administered placebo implants on Days 0, 60 and 120~      The number and severity of phototoxic reactions, the type and duration of sun exposure,~     treatment-emergent adverse events and the use of concomitant medication will be recorded by~     patients in study diaries between Days 0 and 180. Quality of life will be measured using the~     DLQI and EPP-QoL at Days 0, 60, 120 and 180. Participants will visit the clinic on Days 60,~     120 and 180 for assessments of adverse events.~      A subset of patients will be photoprovoked on the lower back and dorsal surface of the hand~     and the minimal symptom dose (MSD) will be determined on Days 0, 30, 60, 90 and 120.~   "
110864|NCT01605123|"~     The investigators hypothesize that cardiovascular and metabolic alterations due to obesity~     already manifest at childhood age.~      To identify these alterations and risk factors, the investigators have established a cohort~     of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation~     of cardiovascular and metabolic parameters, as well as quantification of biomarkers of~     obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and~     additionally after 5, 7 and 9 years.~      In addition, the investigators will assess the effects of increased physical activity and~     exercise on cardiovascular function.~   "
110865|NCT01605110|"~     The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen;~     2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST)~     (patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and~     ecchymosis. HBOT will be applied as a single pre-operative and a single post-operative~     treatment for patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT~     2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed~     at day 3, 10, 21, 30 & 90 days after surgery. Edema and ecchymosis will be assessed in a~     time series to determine the extent that HBOT reduces these clinical signs. The primary null~     hypothesis to test will be that no differences in scores will exist between treatment and~     control at day 3, 10 & 21 post-surgery. A secondary null hypothesis to test is the time~     required to change a score will be no different between the two groups.~      HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment~   "
110866|NCT01605097|"~     This study will investigate the feasibility of using technology of ultrasound guided HDR~     brachytherapy to focally increase dose to regions within the prostate that are heavily~     infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL)~     can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The~     magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS)~     prior to the brachytherapy procedure to design a dose distribution that will encompass the~     malignant volume with higher than the prescription dose. By its nature, brachytherapy has~     subvolumes that receive (for example)125% of the prescription dose or 150% of the~     prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to~     coincide with the DIL. The limit of dose escalation has been reached at whole prostate~     external beam doses of 81-86 Gy and still failure rates for intermediate and high risk~     disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided~     HDR brachytherapy is perfectly suited to achieving this.~   "
110867|NCT01605084|"~     The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50~     c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside~     reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor~   "
110871|NCT01605032|"~     This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line~     stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy~     before a peripheral blood stem cell transplant may stop the growth of cancer cells by~     stopping them from dividing or killing them. After treatment, stem cells are collected from~     the patient's blood and stored. The stem cells are then returned to the patient to replace~     the blood-forming cells that were destroyed by the chemotherapy.~   "
110872|NCT01605019|"~     The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an~     FDA approved synthetic (man-made) surgical sealant which is currently used to help stop~     leaks in blood vessels during surgery.~      This study is evaluating CoSeal™ when it is applied to various areas of the heart during the~     surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking~     for evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding,~     the occurrence of micro emboli (small particles of air or blood), and the formation of~     cardiac adhesions (scar tissue strands that may form around the heart in the area of a~     previous LVAD operation) in patients who undergo LVAD implantation surgery.~   "
110873|NCT01605006|"~     This post-approval study will follow 60 participants who have ALS, documented chronic~     hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical~     implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who~     are successfully implanted with the device will use it for daily diaphragm conditioning~     sessions. Participants will be followed for at least two years (until the last enrolled~     participant reaches the 2-year follow-up visit). Safety and probable benefit outcome~     measures will be assessed.~   "
110874|NCT01604993|"~     The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates~     on aortic augmentation index, brachial and aortic blood pressures, and subendocardial~     viability ration (SEVR).~   "
110875|NCT01604980|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the~     nitrogen balance method have been well described. Importantly, nitrogen balanced~     underestimates requirements.~      The current DRI requirement for healthy adult males is based on the reanalysis of the~     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by~     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and~     0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group~     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2~     g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70~     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which~     represents about 15 % of calories. Depending on the calculations used for ideal body weight~     some older adults could be getting higher or lower than requirement. There is no~     scientifically derived protein estimate for older adults. Therefore there is a need to~     measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of female elderly~     subjects >75 years using the IAAO technique.~   "
110876|NCT01603927|"~     Bowel cancer is a common disorder in the UK. Most cancers happen when a type of polyp,~     called an adenoma, becomes cancerous. Polyps are growths in the large bowel that can be~     cancerous, non-cancerous, or pre-cancerous (adenoma). Polyps are most commonly detected~     during colonoscopy (camera test of the lower bowel). The removal of adenomas has been shown~     to reduce the subsequent risk of bowel cancer. Current practice is that all polyps are~     removed or biopsied to allow a laboratory diagnosis (histology). This is important as it~     influences if and when patients require follow-up colonoscopies, known as the surveillance~     interval. Patients with only non-cancerous polyps do not need surveillance.~      A new blue light technology, called narrow band imaging (NBI), used during colonoscopy can~     help colonoscopists (doctor or nurse performing the procedure)differentiate between polyp~     types during colonoscopy. NBI is currently available in a large number of UK endoscopy units~     however is variably used. Studies from 'expert' centres have demonstrated that NBI allows~     accurate optical diagnosis of colonic polyps. Benefits of optical diagnosis include avoiding~     removal of non-cancerous polyps and an immediate (on the day) diagnosis for the patient~     including the surveillance interval.~      The primary aim of this study is to evaluate the accuracy with which colonoscopists assess~     the required surveillance interval using optical diagnosis when compared with histology in~     non-expert centres. The investigators will invite 2500 patients, who have been referred for~     colonoscopy, to participate. Patients will undergo a routine colonoscopy the only addition~     being the use of NBI during the procedure. Colonoscopists will provide an optical diagnosis~     at the time of colonoscopy in addition to polyp removal or biopsy.~      The investigators will compare surveillance intervals provided using optical diagnosis with~     the diagnosis from histology and thereby the accuracy with which colonoscopists can use the~     technology. The investigators will also calculate the cost savings to the NHS.~   "
110877|NCT01603914|"~     The aim of this project is to answer the following questions:~      To determine the incidence of catheter related bacteremia (CRB) with three strategies of~     central venous catheter exchange in critically ill adult patients with major burn and to~     determine the regimen that will minimize the risk of bacteremia.~      To determine the incidence rate of catheter colonization in adult patients with major burns.~      The scientific knowledge to be acquired through this project is of likely benefit to the~     care of critically ill patients with burns injury as follows:~      The intention is to improve the outcomes in critically ill patients by minimizing one of the~     most frequent causes of infection in the Burn Intensive Care Unit, those from central venous~     catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease~     costs, and decrease mortality.~   "
110878|NCT01603901|"~     Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard~     technology for treatment of various chronic and acute wounds. The investigators plan to~     evaluate the efficacy and ease of use of this device.~   "
110879|NCT01603888|"~     B-type natriuretic Peptide (BNP) is a cardiac hormone secreted from the cardiac myocytes in~     response to volume load. Plasma levels of BNP, as measured by immunoassay methods, are~     elevated in patients with heart diseases. However, the biological effects of BNP are blunted~     in heart failure and other cardiac conditions. Moreover, the peptide levels are also~     elevated in non cardiac conditions such as the neonatal period, sepsis and renal failure.~     Recent investigations suggest alteration of the peptide molecular structure in heart~     failure. These alterations may explain, at least partially, the reduced biological~     activities of BNP in heart failure.~      Immunoreactive BNP and NT-proBNP have been identified in human urine. It has been suggested~     that urinary BNP correlates with plasma BNP, and may serve as a non-invasive measure for~     this cardiac marker. It is unclear what BNP fractions are cleared in the urine in health and~     disease.~      The aim of the proposed studies is to elucidate precisely the molecular form of BNP in~     various disease and specific physiological states in plasma and urine of infants and~     children.~   "
145708|NCT01147315|"~     The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.~   "
110880|NCT01603875|"~     Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies~     Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~      After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell~     Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5~     IU/ml or more.~      And Simulated post-exposure rabies booster vaccination with a new Chromatographically~     Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies~     vaccine.~      After the simulated post-exposure rabies booster vaccination with a new Chromatographically~     Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all~     patients on day 14 after the booster are 0.5 IU/ml or more.~   "
110881|NCT01603862|"~     Dementia is serious problem and around 700 000 people are affected in the UK alone.~     Currently there is no cure however early diagnosis and effective treatment offers hope for~     reducing the impact. Dementia sufferers require care due to physical disability, cognitive~     deficits, social isolation and emotional symptoms (depression). Delaying the onset of~     dementia will improve quality of life for patients and reduce the cost of residential care~     (£42 000 per person per year).~      People with mild cognitive impairment (MCI) are at high risk of developing dementia. They~     have impaired cognitive abilities, such as memory, but still manage their everyday~     activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6~     years after diagnosis.~      Regular physical activities and performing a variety of cognitive activities reduce the risk~     of dementia and improves abilities and quality of life in healthy people. Therefore a~     combination of these activities may reduce the risk of developing dementia in MCI. The~     investigators want to see if they can develop a program which combines these activities in a~     fun and social way that gets people active and keeps them active. The aims are to improve~     fitness, cognition and quality of life. The investigators plan to use computers and the~     internet to help with the activities and to make them available to people who are isolated.~     Physical activity will involve walking from home, cognitive activities will be computer~     based games and puzzles and socialising will involve regular varied group-based activities.~     Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a~     26 week program. They will then be followed up yearly to monitor their progress. The main~     outcome of the study is engagement in the activities. The investigators will also measure~     fitness, cognition, quality of life and conversion to dementia.~   "
110882|NCT01603849|"~     Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer~     (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally~     advanced or metastatic disease. Important to mention the number of patients that progress or~     recur in central nervous system (CNS). It has been reported that patients with~     adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are~     in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with~     prophylactic cranial irradiation (PCI) is the standard of care in patients without~     progression after locoregional or systemic treatment because the proven benefit in overall~     survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able~     to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our~     knowledge, of PCI in NSCLC that include only the specific group of patients considered in~     high risk of developing brain metastasis.~   "
110883|NCT01603836|"~     The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with~     allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing.~     Allograft by itself is not an effective material as a posterior onlay graft for the PLF in~     adult surgery.~   "
110884|NCT01603823|"~     The purpose of this study is to investigate the morphological and angiological retinal~     changes in different macular diseases.~   "
110885|NCT01603810|"~     Optical coherence tomography (OCT) is an imaging technique which shows the internal~     structure of living tissue (in vivo). It is safe, quick and painless to perform, and does~     not damage the tissue in any way. Recent advances in the technology mean that it can now be~     used to take images of the internal structure of the skin. This is useful because certain~     conditions, such as skin cancers, alter this structure. At present a suspected skin cancer~     is identified by taking a sample (a biopsy) which is analysed under the microscope to~     confirm the diagnosis. The cancer is then excised including a margin of apparently~     healthy-looking skin around it to ensure that the entirety of the tumour is removed. The~     excised tumour is then analysed again under a microscope to confirm that it was indeed~     completely removed (histology), after which a further operation is required to repair the~     defect.~      The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer~     called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the~     eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC~     with the current 'gold standard' of histology. OCT could potentially improve the~     investigators ability to define the margins of the tumour before surgery and become a guide~     for minimally invasive surgery. The preservation of healthy tissue represents a priority,~     particularly in the area of the skin surrounding the eye.~   "
110886|NCT01603797|"~     The aim of this study was to investigate if guided internet-delivered acceptance and~     commitment therapy (ACT)would help chronic pain patients.~   "
110887|NCT01603784|"~     The purpose of this randomized, controlled, prospective study is to evaluate the benefits of~     combining aerobic exercise with cognitive training for optimizing cognitive function. The~     study will enroll 109 men and women, age 55-75 years who are in stable health and without~     contraindications to exercise or evidence of dementia or cognitive impairment. Individuals~     will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health~     Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training,~     and Home Exercise and Health Education. Participants will undergo measurements of cognitive~     function, physical performance, and complete questionaires about daily activities, physical~     activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after~     baseline.~   "
110888|NCT01603771|"~     The goal of this pilot study is to evaluate whether healthy, sedentary older adults have~     increased activation of specific brain areas, in response to exercise and cognitive~     training, in comparison to a control group, and whether improvements in psychometric test~     performance are related to increased activation of brain networks. Participants, between age~     55-75 years will be recruited from an ongoing study of exercise and cognitive training, to~     undergo Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).~   "
110901|NCT01604824|"~     The purpose of this study is to assess the pharmacodynamic (PD) effect of alirocumab on~     serum low-density lipoprotein cholesterol (LDL-C) in patients with autosomal dominant~     hypercholesterolemia (ADH) and gain-of-function mutations (GOFm) in 1 or both alleles of the~     proprotein convertase subtilisin/kexin type 9 (PCSK9) gene or with a loss-of-function~     mutation (LOFm) in 1 or more alleles of the apolipoprotein B-100 gene (apoB).~   "
110914|NCT01604655|"~     The purpose of this study is to determine the best initial test in patients admitted to the~     hospital complaining of chest pain.~   "
110889|NCT01603758|"~     The underlying hypothesis is that whole body cholesterol - including cholesterol present in~     tissues that cannot be measured by standard blood tests - is related to heart disease risk.~     Endogenous cholesterol will be labeled with an intravenous infusion of one type of~     cholesterol tracer and dietary cholesterol will be labeled with another. These tracers will~     be used to measure how fast cholesterol is synthesized and excreted using mass spectrometry~     to distinguish the tracers. Data will be related to circulating biomarkers (blood tests) and~     to the thickness of the lining of the carotid artery. The effect of the drug ezetimibe on~     these processes will also be determined. Successful completion of this study will give us~     more knowledge about cholesterol metabolism that may be useful in designing new drugs and~     treatments for patients with heart disease, especially those that are already receiving~     maximum amounts of current medications.~   "
110890|NCT01603745|"~     Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as~     insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased~     risk for cardiovascular disease (CVD). Of note, risk factors for CVD including~     dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The~     investigators want to evaluate the effects of two different types of E/P therapy on~     cardiovascular risk in PCOS.~   "
110891|NCT01604954|"~     Weight management is a critical issue in developed countries where the prevalence of obesity~     is always increasing. While the mismatch of energy intake and energy expenditure is~     recognized as a leading cause of obesity, knowledge related to the determinants of healthy~     eating patterns are still an important issue to further address. Various nutrition-education~     campaigns have been implemented as a way to increase knowledge about healthy foods and~     facilitate the adoption of better eating behaviors. There is currently social and politic~     pressure on health authorities to increase availability of nutrition information as a way to~     tackle the obesity epidemic. Does nutrition information on food labels really contribute to~     improving dietary intake among the population and to helping them to better manage their~     body weight? Some evidence suggests that describing foods as healthy might have unintended~     enhancement effects on the acute amount of food and calories consumed. A better~     understanding of how and why nutrient and calorie labels influence acute and chronic intake~     is thus needed. This study investigate how providing nutritional information on food labels~     influences intake and eating-related variables over a 10-day period among women~     characterized by varying levels of adiposity. As it has never been investigated before, the~     present research will provide important knowledge on the long-term impacts of different food~     labeling strategies on the regulation of food intake. It will also help to determine whether~     weight status could influence the effects of perceptions about foods on intake, so that the~     investigators can identify individuals who mostly tend to overeat in specific situations.~     Consumer advocacy organizations are urging government to adopt policies regarding food~     labeling. Such research is thus of great relevance for the promotion of healthy body weight~     at the population level, as it will clearly contribute to assess how food labels should be~     used by health governing bodies in the context of the obesity epidemic.~   "
110892|NCT01604941|"~     The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron~     overload whose primary diagnosis is hereditary or congenital anemia.~      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to~     patients with transfusional iron overload.~   "
110893|NCT01604928|"~     The study is intended to test efficacy, safety and tolerability of two doses of YM178~     against placebo and tolterodine to treat patients with symptoms of over active bladder.~   "
110894|NCT01604915|"~     Single shot caudal epidural block is one of the most widespread technique for pediatric pain~     management after infraumbilical surgical procedures.~      However, in a significant proportion of patients, despite good initial analgesia from a~     caudal block with local anesthetic, pain develops after the block resolves.~      In order to decrease postoperative analgesic requirements after caudal block, various drugs~     such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been~     investigated. However, their use has been limited by adverse effects in children.~      Recently, many study suggested that epidurally administered dexamethasone could reduce the~     incidence and severity of postoperative pain in adults. But there is no study concerning the~     use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.~      The investigators performed prospective randomized double-blind study to examine the~     analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal~     analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.~      80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this~     prospective, randomized, double-blinded study. After inhalation induction of general~     anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal~     saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R ,~     dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain~     was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,~     0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be~     followed for the duration of hospital stay, an expected average of 3 hours.~      After discharge, rescue analgesic consumption, pain scores, and adverse effects were~     evaluated for 24h.~      The time to first supplemental oral analgesic medication demand was defined as the time from~     the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation.~     Twenty-four hours after surgery, reports of delayed side effects and demands for rescue~     analgesics from the child were gathered from parents via a telephone interview.~   "
110895|NCT01604902|"~     PURPOSE - The purpose of this study is to identify and determine miRNA expression and their~     targets before and during biological treatment of psoriatic patients.~      HYPOTHESIS - Changes in the expression of specific miRNAs play an important role for the~     cytokine expression profile seen in lesional psoriatic skin. miRNAs may therefore serve as a~     potential target for future anti-psoriatic treatment as well as possible predictors of~     biological treatment response.~      PERSPECTIVES - The results from this novel research project will increase the investigators~     understanding of the underlying mechanisms leading to psoriasis. Furthermore it is possible~     that predictors of treatment response can be identified. Identification of biomarkers~     predicting treatment outcome will individualize patient care, reduce number of treatment~     failures and thereby have a tremendous socio-economic impact and increase the patients~     quality of life.~   "
110896|NCT01604889|"~     The study design includes an open-label, dose escalation phase followed by a blinded,~     randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved~     therapy and compares to approved therapy plus placebo in metastatic melanoma patients.~   "
110897|NCT01604876|"~     The purpose of this clinical trial is to investigate whether light therapy is a suitable~     treatment option for depression and insomnia in Parkinson's disease.~   "
110898|NCT01604863|"~     The primary purpose of this study is to determine the maximally tolerated dose (MTD) of~     HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus~     carboplatin, cisplatin plus etoposide, or docetaxel.~   "
110899|NCT01604850|"~     This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin~     (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C~     virus (HCV) infection as assessed by the proportion of participants with sustained virologic~     response (SVR) 12 weeks after discontinuation of therapy (SVR12).~   "
110900|NCT01604837|"~     The recommended entry angle for superior hypogastric plexus block is different among~     references, and there is a need for suggesting a more accurate entry angle for this~     procedure. The investigators are trying to evaluate the entry angle for superior hypogastric~     plexus block by measuring these angle on the computed tomography image and apply these angle~     to the real patients.~   "
110902|NCT01604811|"~     Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent~     published works pointed out that urine and serum markers could be used for detection of~     prostatic inflammation.~      The aim of the study is to assess the activity on inflammation biomarkers (serum and urine~     inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the~     treatment of urinary symptoms related to BPH.~      The potential links between serum and urinary markers of inflammation and BPH clinical~     symptoms at baseline and on treatment will be explored.~   "
110903|NCT01604798|"~     No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer~     (CRC). Therefore, it is urgent that accurate and reliable serum biomarkers be identified.~   "
110904|NCT01604785|"~     There has been little advancement in abortive migraine therapies in recent decades, and few~     proven treatments exist for acute migraine, particularly in children. Propofol, a general~     anesthetic, has been suggested to be effective for the treatment of migraine headaches in~     adults when used in subanesthetic doses (lower doses than those used for anesthesia or~     sedation). Initial retrospective review of the investigators experience with propofol for~     migraine in children suggests that it is safe and may be more effective than standard~     treatments used in the emergency department. The investigators retrospective series had a~     small subject population and a larger study is needed to compare propofol to current~     available treatments.~      All subjects presenting to the pediatric emergency department with signs/symptoms of~     migraine headache will be screened for the study. Subjects who are eligible will be provided~     information about the study and consent/assent forms from a member of the research team, and~     asked whether they are interested in participating.~      All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their~     headache if they have not already tried these first-line treatments at home; those with~     persistent symptoms requiring further treatment who consent to participate in the study will~     be randomized to receive either standard treatment or propofol. Standard treatment currently~     consists of a cocktail of medications that include anti-nausea medicines (metoclopramide~     and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects~     assigned to the experimental group (Propofol) will receive the same intravenous fluids and~     up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated~     on a scale from 0-10) before and after treatment. During treatment they will have close~     monitoring of their vital signs. No additional laboratory tests or procedures are involved.~     Post-visit clinical data will be collected from the subject's medical record and subjects~     will be called by telephone 24-48 hours after discharge from the emergency department to ask~     how they are doing and whether they required any additional treatments such as home~     medications or by other medical professionals other than OHSU.~      The study data will be presented in summary tables that outline subjects' clinical~     presentation prior to treatments, and response to study drug during their visit. The main~     variables of interest include effectiveness (determined as a reduction in self-reported pain~     score), length of stay in the pediatric emergency department, recurrent headache requiring~     emergency treatment within 24 hours and whether any adverse effects occur. These will be~     compared between the 2 study groups with basic statistics.~   "
110905|NCT01604772|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     progressive, recurrent, or metastatic adenoid cyst carcinoma (cancer). Akt inhibitor MK2206~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
110906|NCT01604759|"~     In this study the investigators are conducting research to determine whether a new optical~     device using polarization reflectance spectroscopy can help doctors or dentists identify~     abnormalities in the mouth that require follow-up. To establish this, measurements are~     needed from a large number of individuals with different abnormalities in their mouth.~      The investigators believe the proposed approach has potential to improve and enable mass~     screening for precancerous and early cancers of the oral cavity by improving the predictive~     value of oral cavity exams, particularly for less experienced practitioners.~      The information from this study will be compared to results from the pathology report of the~     tissue taken from your mouth.~      Hypothesis:~        1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal~          and reactive oral lesions.~        2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have~          characteristics associated with a high risk of progression to cancer.~   "
110907|NCT01604746|"~     The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted~     (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.~   "
110908|NCT01604733|"~     Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in~     patients taking lipid lowering agents for at least 3 months ( with no drug change or dose~     amendment for a minimum of 6 weeks).~   "
110909|NCT01604720|"~     Sample size definition provides important information, allowing the groundwork for~     transparent reporting. The sample predefinition allows the trial to be large enough to be~     able to address the question that is being asked.~      The aim of the present study is to assess, in all the randomized controlled trials (RCT)~     included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of~     reporting sample size the accuracy of the calculations, the accuracy of the a priori~     assumptions and the effect on the agreement with pooled results in meta-analyses.~   "
110910|NCT01604707|"~     Background An increasing number of patients are suffering from stress-related symptoms and~     diseases. No scientific studies have examined the effects of Medical yoga on stress-related~     symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga~     treatment in patients with stress-related symptoms and diagnosis in primary health care.~      Methods A randomized, controlled study was performed at a primary health care centre in~     Sweden from March to June 2011. Patients were randomly allocated to a control group~     receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week,~     over a 12-week period in addition to the standard care. A total of 37 men and women, mean~     age 53±12 years, seeking care for stress-related symptoms at the primary health care centre~     were included and followed up after the 12-week study period. General stress level (measured~     using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)),~     anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity~     (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health~     status (Euro Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.~   "
110911|NCT01604694|"~     Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently~     more and more anaesthetists are turning to regional analgesia for anterior abdominal wall~     surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound~     guidance.~      The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in~     post operative period of abdominoplasty.~   "
110912|NCT01604681|"~     The purpose of this study is to evaluate the effect of supplementation with flaxseed oil~     combined with a nutritional counseling in reducing cardiovascular risk factors in~     homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and~     cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C~     polymorphisms of methylenetetrahydrofolate reductase gene.~   "
115331|NCT01546532|"~     This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with~     chronic heart failure. In addition safety and effects on renal function and biomarkers will~     be assessed.~   "
110915|NCT01604642|"~     The goal of the investigators study is to investigate the role of a hormone named Activin A~     (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the~     investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy~     gene program. To answer this question, the investigators plan first to compare circulating~     levels of ActA in cancer patients with and without cachexia. In a second step, the~     investigators would like to assess whether ActA circulating levels are predictive for the~     development of cachexia and short survival.~   "
110916|NCT01604629|"~     The purpose of this study is to demonstrate that patients with Spondylarthropathies in~     remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior~     to the currently recommended dose schedule.~   "
110917|NCT01604616|"~     The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon~     liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment~     ,associated with giant retinal tears.~   "
110918|NCT01604603|"~     Background: Menstrual disturbance is the major complain in reproductive age women, the~     clinical and biochemical characteristics of women with different menstrual disturbance had~     not been well-understood. Objective: To study the clinical and biochemical characteristics~     of women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method:~     Retrospective study, medical records reviewed in patients who visited to outpatient clinic~     of Reproductive Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1~     to 2011 Nov. 31. Including criteria: Patients had sufficient medical records~     (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45. Excluding~     criteria: (1) Women who experienced menarche <3 years before the beginning of the study; (2)~     Women who received hormones or drugs for major medical diseases; (3) Women who presented~     ovarian cysts or ovarian tumors, uterine abnormality; (4) Women who were >45 years old.~   "
110919|NCT01604590|"~     This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is~     being treated with bevacizumab. This study will use a new MRI technique to compare the~     images of blood vessels and tumor structure to the effectiveness of bevacizumab.~   "
110920|NCT01604577|"~     The primary research goals of this application are to characterize social factors including~     health literacy and numeracy skills of CKD patients and examine associations with knowledge,~     self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an~     efficient interactive educational intervention to facilitate patient-provider communication.~     The investigators will accomplish these goals by executing a cluster-randomized controlled~     trial and performing detailed analysis of baseline measures. The specific aims of this study~     are:~      Specific Aim 1: Determine the association of social factors with patient kidney knowledge,~     self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to~     advanced CKD.~      Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated~     with older age, non-white race, fewer years of education, lower socioeconomic (income)~     status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with~     medication and diet self-care recommendations. Low literacy/numeracy is also associated with~     higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.~      Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used~     cooperatively by physicians and patients to improve self-care and outcomes in CKD.~      Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool~     will be feasible and associated with higher patient kidney knowledge, self-efficacy of~     self-care and greater adherence to medication and nutrition recommendations compared to~     usual care.~   "
110921|NCT01604564|"~     The purpose of this registry is to collect information about patients in which a pouch has~     been created to improve in the future the quality of the surgery of the pouch.~   "
110922|NCT01604551|"~     Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell~     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with~     emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been~     characterized during septic shock and may contribute to dissemination of pro-inflammatory~     and procoagulant mediators. This is a prospective observational study of circulating MPs and~     blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU~     at baseline (D1), D2, D3, D4 and D7.~   "
110923|NCT01604538|"~     RAZIONALE~      Pulmonary embolism is a complex disease, with a highly variable clincal presentation.~     Diagnosis starts with clinical probability assessment mainly based on medical history and~     rapidly available clinical data. Pulmonary embolism can be managed by emergency department,~     cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical~     management can varies based on the attitude of the attending physician.~      Diagnosis is a crucial point as it can influence short term mortality.~      OBJECTIVE~      The registry has 3 main objectives:~        1. educational objective,~        2. improvement in the knowledge of epidemiology, management and outcome of acute pulmonary~          embolism in Italy~        3. scientific objective~   "
110924|NCT01604525|"~     The RealU2 is a randomized controlled trial to determine the efficacy of an online health~     and wellness program for young adults with the addition of individualized peer health~     coaching.~   "
110925|NCT01604512|"~     This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation~     injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the~     tumor cells are actively growing. The investigators will do these two tests and see which~     one is better.~      Optional Second MRI Perfusion~      The investigators may ask the patient to undergo a second MRI perfusion scan. They are~     testing this second scan to see how well it works. It can cover the entire brain. It takes~     about an 5 extra minutes in the scanner. If they decide to undergo this second scan, they~     will divide the usual IV contrast dose into two parts. The patient will not receive extra IV~     contrast for this second scan. This second scan is optional.~   "
110926|NCT01604499|"~     This study builds on the framework of a previously implemented color-coded food labeling~     intervention in a hospital cafeteria by testing the incremental effectiveness of providing~     employees with individual feedback and incentives for increasing healthy purchases in a~     3-arm randomized controlled trial. The investigators hypothesize that employees assigned to~     receive feedback will increase healthy purchases more than employees who receive no contact~     and that employees who receive feedback plus incentives will increase healthy purchases more~     than those who receive feedback alone.~   "
110927|NCT01604486|"~     There is a sharp rise in the rate of coronary heart disease diagnoses and chest pain~     consultations in the 90 days before a first heart attack. There is some evidence that chest~     pain and angina symptoms in this period have a beneficial effect on heart attack outcomes in~     hospital and shortly after discharge. However, the available evidence is lacking in three~     key areas. First it is based on a retrospective patient report of symptoms after the heart~     attack has occurred; this means that patients are required to survive their heart attack and~     may make errors when reporting prior symptoms. Second, evidence for an effect on longer term~     outcomes, and coronary outcomes in particular (e.g. coronary death, further heart attacks)~     are unknown. Third, there is conflicting evidence that these effects might differ by age, in~     men and women, and according to treatment in hospital.~      The investigators hope to address the limitations in the evidence by performing a large,~     prospective study of the occurrence, timing and effect of different types of symptoms and~     disease diagnoses occurring before heart attack.~      The investigators hypothesise that prospectively collected, clinical measures of chest pain~     symptoms and cardiovascular diagnoses in primary care will have a beneficial effect on short~     term coronary mortality and may have a beneficial effect on longer term coronary outcomes.~   "
110928|NCT01604473|"~     An arterio-venous fistula is a surgical procedure that supports access for people undergoing~     hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks~     to better understand the factors that contribute to the successful maturation of an~     arterio-venous fistula. A primary aim of this study is to see if endothelial function (the~     biochemical events initiated by cells lining the arteries) is associated with successful~     maturation. Other aims include determining if pro-inflammatory markers in the blood or~     evidence of gene expression are associated with successful maturation.~   "
110929|NCT01604460|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part V is comparing~     standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso~     wrap in full term infants from resuscitation to one hour after birth.~   "
110930|NCT01604447|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of~     a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following~     removal from their incubator to assist with temperature regulation.~   "
110931|NCT01604434|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part III is for~     preterm/low birth weight infants with or without a plastic torso wrap during the first hour~     after birth to assist with temperature regulation during placement in an incubator.~   "
110932|NCT01604421|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part II is for preterm/low~     birth weight infant with or without plastic head cover used from 1 hour after birth until~     discharge or 24 hours after birth to assist with temperature regulation.~   "
110933|NCT01604408|"~     LY2495655 is an investigational drug being tested for muscle wasting. Muscle wasting~     includes shrinking of the muscle and weakness. This can occur when a muscle is no longer as~     active as usual. When muscles are no longer in use, they become weaker.~   "
110934|NCT01604395|"~     The purpose of this study is to evaluate the long-term safety and effectiveness of growth~     hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency),~     TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS~     (Idiopathic Short Stature).~   "
110935|NCT01604382|"~     Patients undergoing elective total knee arthroplasty are randomized to either intrathecal~     anesthesia, wound infiltration with local anesthetics and standardized postoperative care~     (NA = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with~     accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce~     length-of-hospital stay. Outcome variables are postoperative nausea and vomiting,~     mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.~   "
110936|NCT01604369|"~     The hypothesis of the present study is to evaluate cryoablation(cooling of the tissue) as~     standard therapy of common atrial flutter,focusing on efficacy, feasibility, procedure time,~     and patient content.~      The purpose of this study is to determine whether cryoablation, performed only by operators~     experienced in cryothermic ablation is effective and safe in the treatment of atrial~     flutter.~   "
110937|NCT01604356|"~     Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt~     to slow, halt or reverse the retinal disease process, and claim success with some approaches~     such as acupuncture, but this potential treatment has not been put to the test of objective,~     rigorous scientific study conducted in western society. In this pilot study, the~     investigators aim to evaluate an acupuncture treatment tailored to the RP population for its~     feasibility to improve visual function, specifically visual field and dark adaptation. The~     study results may provide a basis for eye care providers' recommendations to RP patients~     regarding whether to consider acupuncture as a potential treatment modality. If our~     hypotheses regarding improvements in vision beyond typical test variability are supported,~     our future research goals include the conduct of a larger clinical trial with involving~     randomization and a placebo control for acupuncture in RP.~   "
110938|NCT01604343|"~     The purpose of this study is to assess the efficacy of sirukumab as measured by the~     reduction of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of~     radiographic progression in patients with active RA who are unresponsive to treatment with~     disease-modifying antirheumatic drugs (DMARD).~   "
110939|NCT01604330|"~     The main objective of this study is to show the effectiveness to a year of baclofen compared~     to placebo, on the proportion of patients with a low risk alcohol consumption or no,~     according to the WHO standards.~   "
115673|NCT01542060|"~     This study is conducted in Asia. The aim of this observational study is to collect efficacy~     and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal~     clinical practice conditions.~   "
110940|NCT01604317|"~     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation~     care will reduce the incidence of hypothermia in preterm/low birth weight and full term~     infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low~     birth weight infant with or without plastic head cover used during resuscitation.~   "
110941|NCT01604304|"~     Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave~     lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature,~     the two procedures are available to treat these stones with a good stone free rate. There is~     no prospective randomized study comparing these two treatments. Our study will define with a~     good level of evidence which technique is the best with regard to the stone free rate,~     secondary procedure rate and adverse effect.~   "
110942|NCT01604291|"~     This multi-center, observational study will evaluate the efficacy and safety of dual and~     triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis~     C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin~     plus telaprevir/boceprevir will be observed for the duration of their treatment and for up~     to 24 weeks of follow-up.~   "
110943|NCT01604278|"~     This study assessed the efficacy, safety and tolerability of the co-administration of NVA237~     plus indacaterol taken once daily versus indacaterol taken once daily in patients with~     moderate to severe Chronic Obstructive Pulmonary Disease.~   "
110944|NCT01604265|"~     To investigate the ability of Sativex to relieve central neuropathic pain in multiple~     sclerosis subjects.~   "
110945|NCT01604252|"~     This multi-center, prospective, observational cohort study will evaluate the effectiveness,~     safety and utilization of treatments in patients with advanced basal cell carcinoma and~     basal cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum~     of 8 years, including 3 years for patient recruitment and 5 years follow-up.~   "
110946|NCT01604239|"~     This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events~     than celecoxib in subjects with osteoarthritis.~   "
110947|NCT01604226|"~     The BIS is influenced by multiple parameters, such as age,gender, body weight, height,~     muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is~     thought to be influenced mainly by propofol and remifentanil infusion dose. As such, the~     investigators postulate that the BIS value could be predicted by the estimated effects-site~     concentration of propofol and remifentanil, and try to establish a multiple linear~     regression model for predicting BIS value.~   "
110948|NCT01604213|"~     The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is~     associated with clinically significant reductions in biological markers of inflammation,~     pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a~     population of diabetic patients with coronary artery disease who undergo cardiac~     rehabilitation.~      The pre-specified established biological markers of inflammation, pro-thrombogenicity, and~     atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP,~     platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.~   "
110949|NCT01604200|"~     20% of Canadians are hypertensive with approximately 200,000 new cases each year. Early~     detection of hypertension affects outcomes, reducing the risk for heart attack, stroke,~     kidney disease, and dementia. Screening strategies are required to identify the more than~     one third of Canadians with unrolled high blood pressure, in particular, younger men unaware~     of their condition, women over sixty years old, and underserved groups.~      A collaborative practice model linking dentists to other healthcare providers in a reporting~     network is a promising model for hypertension detection and management. There are 20,129~     licensed dentists in Canada who graduate with the ability to measure blood pressure, and 74%~     of the population visits a dentist each year. This represents an opportunity, but~     information is required on Dental attitudes toward screening for hypertension before~     attempting to initiate a screening model. To engage dentists in hypertension detection~     requires an understanding of the practice environment and the factors that shape their~     beliefs, attitudes and behaviours regarding routine hypertension screening in their~     practices.~   "
110950|NCT01604187|"~     Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the~     patient. The pain associated with the procedure is not caused by the insertion of the scope~     but from inflating of the colon in order to do the inspection. It has been shown that~     colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients~     feel discomfort during the procedure. Factors predicting a painful colonoscopy are~     female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy~     (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are~     associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or~     analgesia are achieved by administering a benzodiazepine or a combination of a~     benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine~     (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol~     as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of~     colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most~     commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely~     increases the cost of procedure; drug administration, need for pulse oximetry monitoring and~     the need for follow-up after the procedure make colonoscopy sometimes expensive and~     troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor~     makes patients forget it (Elphick et al. 2009).~      Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal~     sublingual formulation of fentanyl has been developed to further improve the management of~     pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed~     under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by~     the body through the mucous membrane. After administration of buccal fentanyl maximum plasma~     drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl~     concentrations versus time following buccal and sublingual administration are very similar~     (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the~     tongue at the deepest part. Sublingual administration is an easy and non-invasive method of~     pain treatment for the patient coming to colonoscopy done as an office based procedure.~     Other advantages compared to invasive methods are improved comfort of patients and no need~     for intravenous access because of pain relief. Before, it has been used in the management of~     breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and~     well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use~     of transmucosal tablet for colonoscopy patients is a quite new approach.~   "
110951|NCT01604174|"~     The purpose of this clinical trial is to compare the effectiveness of a new interactive~     virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation~     of patients after total knee arthroplasty.~   "
110952|NCT01604161|"~     This study is conducted in Japan. The aim of this study is to collect information about the~     efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature~     with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature~     with Turner Syndrome where epiphysial discs are not closed.~   "
145878|NCT01145222|"~     The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056~     compared with midazolam to maintain suitable sedation levels in patients undergoing~     colonoscopy.~   "
110953|NCT01604148|"~     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in~     symptomatic failure in more than one third of the patients. Storage symptoms are major~     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate~     (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction~     (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in~     conjunction with the prescription of the anticholinergic drugs.~   "
110954|NCT01604135|"~     The purpose of this study is to determine whether corneal collagen crosslinking is effective~     in the treatment of progressive keratoconus.~   "
110955|NCT01604122|"~     This study is an online (web-based) or paper-based survey for patients with transthyretin~     familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to~     describe the emotional, physical, and financial impact of having TTR-FAP or caring for~     someone who has the disease.~   "
110956|NCT01604109|"~     The purpose of this study is to determine if adding daily application of CPP-ACP containing~     paste for one year is superior to regular fluoride tooth brushing in preventing dental~     caries in high caries risk Thai preschool children.~   "
110957|NCT01604096|"~     Use of information campaigns and educational interventions directed to citizens and~     supported by physicians, aimed at promoting the appropriate use of medicines, have been~     evaluated by several studies with conflicting results. These interventions are potentially~     relevant, favouring the reduction of unnecessary use of medicines and related risks. Several~     studies have specifically evaluated the promotion of the appropriate use of antibiotics in~     adults and children, with variable results. A controlled study has been proposed to evaluate~     the feasibility and effectiveness of a multifaceted intervention aimed at reducing~     antibiotic prescription by increasing awareness on risks of their unnecessary use.~      Information has been provided to citizens through several media (posters, local TV, radio~     and newspapers, video terminals, websites of Local Health Authorities). Brochures with~     information on expected benefits and risks of antibiotics has also been available, either~     with direct access in waiting rooms and pharmacies or handed out and mediated by doctors.~     Physicians and pharmacists received specific data on local antibiotic resistance. A small~     group of representative doctors have also actively participated in defining the campaign key~     messages. A sample of general practitioners and paediatricians have been trained in patient~     counselling strategies.~      The information campaign has been implemented in two Provinces of Emilia-Romagna during the~     fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of~     antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be~     compared versus other areas in the same Region. Knowledge and attitudes of the general~     population will be evaluated through a phone and internet survey on a representative sample.~      This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.~   "
110958|NCT01604083|"~     The aim of the ETPOS study is to describe differences in transfusion habits throughout~     Europe and to correlate these habits to perioperative outcome parameters. Special focus is~     put on the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to~     other blood products or coagulation factors in the operating room. Furthermore the~     motivation of physicians to transfuse PRBC and blood products in the operating room will be~     investigated.~   "
110959|NCT01604070|"~     Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises~     flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with~     hyperextension of the metatarsophalangeal (MTP).~      Etiologies of hammertoe deformity include a foot in which the second ray is longer than the~     first, MTP synovitis and instability, inflammatory arthropathies, neuromuscular conditions,~     and ill-fitting shoe wear. When a foot's second ray is longer than the first and shoe wear~     does not fit correctly, flexion of the PIP joint occurs to accommodate the shoe. This length~     difference also causes MTP synovitis to develop from overuse of the second MTP joint.~     Attenuation of the collateral ligaments and plantar plate result, and the MTP joint~     hyperextends and may even progress to dorsal subluxation or dislocation (see image below).~     Rheumatoid arthritis causes hammertoe deformity by progressive MTP joint destruction,~     leading to MTP joint subluxation and dislocation.~      With all 3 of these etiologies, the extensor digitorum longus (EDL) tendon gradually loses~     mechanical advantage at the PIP joint, as does the flexor digitorum longus (FDL) tendon at~     the MTP joint. The intrinsic muscles fire and sublux dorsally, as the MTP hyperextends. They~     now extend the MTP joint and flex the PIP joint, as opposed to their usual functions of~     flexing the MTP joint and extending the PIP joint.~   "
110960|NCT01604057|"~     This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a~     biomarker of bone formation in postmenopausal women with low bone mass.~   "
110961|NCT01604044|"~     This study evaluates the effects of different therapies in ovulation induction in~     Intrauterine Insemination Cycles.~   "
110962|NCT01604031|"~     This is a research study to determine the safety and effectiveness of using special cells~     that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in~     combination with a drug called Lenalidomide.~      To do this, the investigators will put a special gene into cancer cells that have been taken~     from the subject. This will be done in the laboratory. This gene will make the cells produce~     interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system~     kill cancer cells. Additionally, the investigators will stimulate the cancer cells with~     normal embryonic fibroblasts (cells that develop into normal connective tissues in the body)~     so that they will make another natural protein called CD40 ligand (CD40L). Some of these~     cells will then be put back into the subject's body with the goal that they will act like a~     vaccine and stimulate the immune system to attack the CLL cells.~      The investigators have already conducted a study similar to this in other subjects with CLL.~     In those subjects the investigators saw some changes in the subject's immune system that~     might indicate that the modified cells were helping their immune system fight the cancer.~     However, in most of the subjects this change in the immune system went away after the~     injections were stopped. The investigators think that this may be due to a high level of~     cells called T regulatory cells. T regulatory cells are part of the immune system and~     prevent excessive reactions from other cells in the body. Studies have shown that reducing T~     regulatory cells allows the body to fight the cancer for a longer period of time.~      Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells.~     Using Lenalidomide along with the injections (shots) might help the body fight the cancer~     for a longer period of time. Lenalidomide is also called Revlimid.~      In this study the investigators want to see if they can make the change in the immune system~     last longer by giving Lenalidomide before and at the same time as the vaccine. The~     investigators hope that this might produce a better response directed at the CLL cells.~     Subjects will receive injections for about a year~   "
110963|NCT01604018|"~     Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who~     completed all dosing visits in study CP005 and all visits in study CP005A approximately two~     years after the start of treatment.~   "
110964|NCT01604005|"~     The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT~     radiotherapy is effective in preventing or delaying the onset of chest nodules in patients~     with Mesothelioma.~   "
110976|NCT01603654|"~     Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon~     preparation affects the quality of colon cleansing. The study is aimed at comparing the~     efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and~     low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of~     poor bowel preparation.~   "
110965|NCT01603992|"~     Background:~      - Marijuana is the most widely used illicit drug in the world, yet relatively little is~     known about users who try to quit without formal treatment ( spontaneous quitting). Studies~     have suggested that there are some common strategies that many individuals use in~     spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of~     negative consequences, support from family and friends, and religion. However, more research~     is needed to determine potential treatment strategies for marijuana use.~      Objectives:~        -  To identify strategies used to help with marijuana quitting among non-treatment seeking~          adult marijuana users.~        -  To identify withdrawal symptoms experienced during marijuana quitting and their~          relationship to the quitting strategies used and the outcome of the quit attempt.~        -  To evaluate whether subgroups of marijuana users differ in their experience of~          marijuana quitting.~      Eligibility:~      - Individuals at least 18 years of age who have made at least one attempt to quit marijuana~     use.~      Design:~        -  The study will consist of one visit of approximately 1 to 2 hours.~        -  Participants will fill out three questionnaires. The questionnaires have different~          types of questions, and will ask about background and lifestyle, marijuana use and~          craving patterns and behaviors, and difficulties in previous attempts to quit using~          marijuana.~   "
110966|NCT01603979|"~     This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to~     evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose~     (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and~     preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once~     every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid~     tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated~     in an expansion cohort at the RP2D for safety and anti-tumor activity.~   "
110967|NCT01603966|"~     This study is to determine whether the AggreGuide platelet aggregometer can discern the~     effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the~     agonist.~   "
110968|NCT01603953|"~     Protein-energy malnutrition and muscle wasting are a common finding among patients with~     liver cirrhosis. Its prevalence may range from 50-90% depending on the methods used for~     nutritional assessment. Even stable cirrhotic patients referred as Child A have muscle~     depletion and the majority of patients classified as Child C have significant depletion.~     Malnutrition has been shown to be related to several complications of cirrhosis~      Despite the importance of nutritional status in patient's outcome, there is no gold standard~     for nutritional assessment. Traditional techniques used in healthy subjects to assess~     nutritional status cannot be used in cirrhotic patients due especially to ascites and~     peripheral edema, and altered rates of biochemical markers due to liver failure.~      Bioelectrical impedance vector analysis has emerged as a useful method to assess body~     composition and nutritional status especially in patients at the extremes of body weight~     (fluid overload, excess of adipose tissue, etc.).~      The aim of this study is to evaluate whether malnutrition assessed by bioelectrical~     impedance vector analysis is related to the development of hepatic encephalopathy~   "
110969|NCT01603940|"~     The purpose of this study is to compare losartan and benazepril in diabetic patients whose~     high blood pressure is not controlled by amlodipine and its relationship to statin current~     use.~   "
110970|NCT01603732|"~     The goal of this study is to find out if there is any association between a mother's~     exposure to bacteria that normally causes strep throat and her baby's developing heart~     disease/heart defect.~   "
110971|NCT01603719|"~     The purpose of this clinical trial is to evaluate the effect of a new infant starter formula~     with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.~   "
110972|NCT01603706|"~     The purpose of this study is to evaluate the use of radial strain imaging using speckle~     tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy~     (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT~     indication. Thus assessing the value of lead localization determined by radial strain~     imaging in a prospective, randomized manner.~   "
110973|NCT01603693|"~     Amongst the consequences of missing teeth are change of appearance and difficulties in~     mastication and speech. Dental implants in the maxilla or mandible provide a common~     treatment modality by offering anchorage to fixed or removable fixtures. In many cases, the~     lack of teeth is accompanied by lack of appropriate bone volume in the desired area for~     dental implant placement. Possible causes for this lack of sufficient bone volume are varied~     and include earlier bone atrophy, traumatic tooth extraction and bone resorption due to~     periodontal disease. In such cases, dental implant placement is preceded by alveolar bone~     augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in~     which a bulk of bone substitute is placed in the area which needs more volume before placing~     a dental implant. The bone substitute is covered with an inert membrane and may provide a~     scaffold and encourage cells from the patient to reach the area and build new bone volume. A~     common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM)~     which resembles human bone and helps encourage new bone formation. On the contrary its~     structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate~     is another common bone substitute with easy handling properties and good structural~     stability during early healing. Its replacement by natural bone contributes to the~     augmentation process. Although DBBM efficacy in GBR process has been investigated, using~     DBBM in combination with bi-phasic calcium-sulphate as a binding material during GBR was not~     examined. This prospective study will examine augmented bone quality and quantity following~     a GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in~     a combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will~     precede dental implant placement as custom. The quality and quantity of the new formed bone~     will be assessed by a C.T (computerized tomography) which is done routinely before dental~     implant placement and by further analyses of bone residues which will follow drilling the~     dental implant placement site while preparing it (as common).~   "
110974|NCT01603680|"~     1. Evaluation of the efficacy of the circumferential versus non circumferential~          distribution of mepivacaine around the median and ulnar nerves.~        2. Evaluation the onset of action of mepivacaine in circumferential versus non~          circumferential distribution around the median and ulnar nerves.~        3. Spread of mepivacaine after injection guided by ultrasonography.~        4. Complications of both anesthetic techniques in postoperative time.~   "
110975|NCT01603667|"~     The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg~     versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with~     an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.~      The secondary objectives are as follows:~        -  To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by~          Barthel Index (BI) score at Day 90.~        -  To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent~          stroke, cardiovascular events and death of all causes.~        -  To evaluate the safety of PG2 Injection 500 mg treatment~   "
110983|NCT01603563|"~     The aim of this R34 study is to develop and test the feasibility of a Stepped Care~     intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will~     focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive~     Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a~     randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard~     Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures,~     treatment acceptability and satisfaction, and costs of treatment delivery. Findings from~     this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et~     al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the~     effectiveness of SC-TF-CBT for early childhood PTSD.~   "
110984|NCT01603550|"~     This proposed laboratory study will extend previous findings on relationships between~     cognitive function and nutritional status to conditions that more closely resemble military~     operations where aerobic exercise, inadequate nutritional intake and sleep deprivation~     combine to degrade cognitive function. The investigators will examine cognitive function,~     brain activity and glucose levels in volunteers who are calorie-deprived, performing high~     workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for~     approximately 48 hours. A comprehensive cognitive test battery will be repeatedly~     administered and several cognitive tests will be administered when volunteers are~     exercising. Interstitial glucose levels will be assessed and whole body nitrogen utilization~     determined. The effects of energy restriction and the physiological basis of the~     relationship between peripheral glucose levels and cognitive function will be examined using~     a state-of-the-art imaging technology, functional Magnetic Resonance Imaging (fMRI). This~     technique will allow any key brain regions affected by caloric deprivation to be identified.~   "
110985|NCT01603537|"~     Trauma is the leading cause of death among persons below 60 years of age. It is a~     well-established belief that optimal treatment in the early phase after trauma has a major~     impact on mortality, and the implementation of specific educational programs for trauma care~     have been a widely adopted strategy aimed at improving the outcome. This strategy has high~     face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support~     (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the~     Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital~     caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one~     of the leading educational programs for prehospital emergency trauma care. However, the~     scientific support for improved patient outcome from courses such as PHTLS and ATLS is~     limited. According to a Cochrane analysis published 2010 there is no evidence to recommend~     advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis~     concerning ATLS gave similar results and a recent study indicated even worsened outcome~     after the implementation of ATLS. An observational study in the county of Uppsala indicated~     reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a~     low overall mortality. The aim of this study is to further investigate the association~     between PHTLS training of ambulance crew members and the outcome in trauma patients in a~     larger study population. To accomplish this the investigators will use an epidemiological~     semi-individual design applied to all victims of traffic injury that occurred during the~     implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets~     of patients will be analyzed: Mortality before hospital admission, mortality within 30 days,~     time to death among survivors to hospital admission and return to work among survivors to~     hospital discharge.~   "
110986|NCT01603524|"~     This proposal outlines the design of a cluster randomized controlled trial to compare the~     effectiveness of a new approach to integrating smoking cessation services into routine~     interactions with patients in the primary care setting using an adaptation of the Ottawa~     Model for Smoking Cessation (OMSC). The OMSC aims to systematically identify the smoking~     status of all patients, provide brief cessation advice, and offer evidence-based cessation~     support to those interested in embarking on a quit attempt. This study will provide~     important new evidence to assist with the development of a more comprehensive cessation~     system in the province of Ontario and across Canada.~   "
110987|NCT01603511|"~     The study will compare the rewarming effectiveness of heat donation through the head or the~     torso during rewarming of mildly hypothermic subjects. Warming will be accomplished through~     either forced-air warming or using a charcoal heater; both units are commonly used for~     warming. The investigators hypothesize that head warming will be as, or more, effective~     compared to~   "
110988|NCT01603498|"~     The main aim of the present study was to investigate the effect of preemptive dexamethasone~     and methylprednisolone to prevent pain, swelling and limitation in mouth opening following~     third molar extraction.~   "
110989|NCT01603485|"~     The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different~     modified-release formulations of lersivirine and compare it to the PK of the~     immediate-release tablet. The effect of food on the PK of one of the modified-release~     tablets will also be assess along with the safety and tolerability of each treatment.~   "
110990|NCT01603472|"~     Parenteral nutrition (PN) is the provision of nutrients via the intravenous route.~     Parenteral nutrition associated metabolic bone disease (MBD) was first described in children~     in the 1980s. Since then, there has been little to no research into the underlying~     relationship and as a result, little evidence on which to base clinical care. In adults, MBD~     is associated with increased fractures. At the Hospital for Sick children in Toronto, an~     intestinal failure program has been set up since 2003. This is the only intestinal failure~     program in Canada and receives country wide referrals. Most of the patients have short bowel~     syndrome (SBS) and require PN for prolonged periods, or for life. About 90% of these~     patients have MBD, and some have had bone fractures. An understanding of the etiology of MBD~     would provide information to guide care, and prevent this condition. Funding for this area~     of research however is challenging because intestinal failure requiring long term PN is a~     rare condition, accounting for approximately 200 - 300 children in all of Canada. The goal~     of this study therefore is to gather pilot data on markers of MBD in children on long term~     PN, and to compare these markers to age and gender matched control patients who are fed by~     mouth or feeding tube. The information gathered from this study will help us begin to~     understand what is actually happening in the bones of children on long term PN and will form~     the basis for future studies and improved clinical care.~   "
110991|NCT01603459|"~     The purpose of this study is to determine whether injections with increasing doses (up to~     800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and~     effective in treating patients with spasticity on one body side due to cerebral causes.~   "
111024|NCT01603030|"~     This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate~     the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual~     administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post~     Operative Inflammation and Infection in LASIK surgery.~   "
110992|NCT01603446|"~     MELAS patients suffer from exercise intolerance, weakness, poor vision or blindness, poor~     growth, developmental delay, and deafness. They also have unique 'stroke-like' episodes~     (SLEs) which are not due to blockages of large or medium arteries. These 'strokes' are~     thought to be due to energy failure of very small brain blood vessels combined with energy~     failure in the mitochondria (cell battery) of the brain cells, especially in the back region~     of the brain in the vision centre. This leads to visual loss and paralysis. The overall goal~     of this study is to better understand the mechanism of these SLEs at the level of the brain~     cells and small blood vessels.~   "
110993|NCT01603433|"~     This is a single center, prospective, non-randomized, feasibility study for the evaluation~     of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of~     incompetent saphenous veins.~   "
110994|NCT01603420|"~     The purpose of this study is to compare the effects on prostate cancer using radiation~     therapy with or without chemotherapy.~   "
110995|NCT01603407|"~     The Finding the Optimum Regimen for Duchenne Muscular Dystrophy (FOR DMD) study will compare~     three ways of giving corticosteroids to boys with Duchenne muscular dystrophy (DMD) to~     determine which of the three ways increases muscle strength the most, and which causes the~     fewest side effects. Using the results of this study, the investigators aim to provide~     patients and families with clearer information about the best way to take these drugs.~   "
110996|NCT01603394|"~     The primary objective is to explore whether sensory symptom cluster analysis is useful for~     predicting treatment response in Postherpetic Neuralgia.~   "
110997|NCT01603381|"~     The investigators intend to assess the following:~        -  the efficacy of CBTi in treating insomnia during recovery,~        -  does a family history of alcoholism moderate the insomnia symptoms,~        -  does an improvement in insomnia lead to a decrease in impulsivity.~   "
110998|NCT01603368|"~     Mortality and incidence of severe complications is still high among extremely premature~     infants. Common causes of severe complications in this population are poor nutrition,~     necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common~     problem resulting in prolonged need for intravenous lines and poor nutrition.~      The aim of the study is to evaluate whether supplementation with the probiotic bacterium~     Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight~     increases feeding tolerance to breast milk and thereby improves nutrition, increases growth~     and reduces serious complications and mortality in this population. Beyond this, possible~     mechanisms underlying these effects will be analyzed in stool, breast milk and blood~     samples.~   "
110999|NCT01603355|"~     The investigators are doing this research study to see if tocilizumab (Actemra) is safe and~     effective when used for severe or refractory non-infectious uveitis. Uveitis is an~     inflammation of the eye that is caused by the body's immune system reacting against the eye~     tissues.~   "
111000|NCT01603342|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     determine the feasibility of demonstrating a quantifiable change from baseline in punch~     biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving~     clopidogrel anti-platelet therapy.~   "
111001|NCT01603329|"~     The goal of this project is to increase patient adherence to medication using communications~     and incentives for physicians. The investigators are partnering with a health insurance~     company, Humana Inc, to design and implement an incentives program for physicians whose~     patients increase their medication adherence for oral diabetes medication, hypertension~     (ACEI or ARB) medication, and/or cholesterol (statins) medication. The investigators will~     use behavioral economics to explore the best way to communicate the incentives to the~     physicians.~   "
111002|NCT01603316|"~     The investigators have found that many patients getting treatment for cancer have trouble~     getting enough to eat, or do not always have enough money for food. When a patient has these~     problems it can lead to difficulties with completing cancer treatment. Across New York City,~     there are many hospitals that offer their patients food pantry services on location. The~     investigators would like to compare how food pantries within the hospital and two other food~     assistance options: monthly food vouchers and weekly grocery deliveries maybe possible~     solutions to this problem. The patient will be randomly assigned to one of the three~     different food program groups, which means everyone has an equal chance in being in any~     group, like a flip of a coin. The investigators hope to learn how to best help patients with~     trouble getting food and to see if this will help with completing cancer treatment.~   "
111003|NCT01603303|"~     Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning~     after treatment in women who are in menopause and who had breast cancer that was sensitive~     to the hormone estrogen.~      The goal of this study is to learn if it is possible to prevent some AI side effects,~     particularly problems with vaginal dryness and pain during sexual activity. Researchers also~     want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid~     vaginal dryness. Researchers want to see if preventing these side effects will decrease the~     number of women who stop taking AIs due to the side effects they cause.~   "
111004|NCT01603290|"~     The purposes of this study are to (1) explore the severity of symptom of leukemia patients~     experienced before and after chemotherapy in hospital, (2) investigate the trajectories of~     the fatigue and physical fitness, and their related factors, and (3) the correlation between~     fatigue and physical fitness~   "
111005|NCT01603277|"~     This study will evaluate the safety, tolerability and efficacy of a single dose level of~     KB003 in subjects with inadequately controlled asthma.~   "
111006|NCT01603264|"~     In this study, healthy male volunteers will receive a single intravenous administration of~     either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During~     the course of the study, the pharmacokinetics will be assessed by sampling the levels of~     drug in the blood, and by comparing these levels among the different administration arms of~     PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability,~     and immunologic response also will be evaluated throughout.~   "
111007|NCT01603251|"~     The purpose of this study is to determine the safety and impact of ivermectin, administered~     as single or repeated dose, in combination with artemether-lumefantrine in reducing the~     proportion of mosquitoes that survive and become infected after feeding on a blood meal from~     a malaria-infected individual.~   "
111008|NCT01603238|"~     This was an open-label, non-randomised, single-dose study in 6 healthy male subjects.~     Subjects attended a screening visit within 28 days before drug administration. Subjects were~     admitted to the clinical unit on the morning of the day before dosing (Day -1) and received~     a single oral administration of study drug in a fasted state on Day 1. Subjects were~     resident in the clinic for up to 7 days after dosing; they could be discharged sooner if a~     mass balance cumulative recovery of >95% was achieved, or if a mass balance cumulative~     recovery of >90% was achieved and <1% was collected within 2 separate, consecutive 24 h~     periods. At specified times during the study period, blood samples were taken and urine and~     faeces were collected for PK analysis. Safety assessments were also performed.~   "
111009|NCT01603225|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities, such as speech, language and other efforts at~     communication in individuals with autism.~      In this research, battery powered device is used to deliver very weak electrical current to~     the surface of the scalp while participants are involved in tasks aimed at training or~     measuring communicative efforts, speech, language or related cognitive functions. Our aim is~     to find out whether tDCS will improve these mental abilities.~   "
111010|NCT01603212|"~     The goal of the Phase I part of this clinical research study is to find the highest~     tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in~     combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The~     safety of this combination will also be studied.~      The goal of Phase II is to learn if this study drug combination can help to control advanced~     or metastatic melanoma.~   "
111011|NCT01603199|"~     Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a~     progressive course that can lead to liver cirrhosis. There are few studies on dietary~     management in primary biliary cirrhosis and most of them have focused on micronutrients~     specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent~     hyperlipidemia, but few recommendations have been made regarding a complete dietary~     approach. Fiber has been proven to increase the excretion of nitrogen products and~     consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has~     shown to decrease endogenous catabolism in cirrhotic patients.~      The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in~     the nutritional status of patients with primary biliary cirrhosis.~   "
111012|NCT01603186|"~     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single~     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test~     Product and the corresponding Reference Product under fed condition in normal, healthy,~     adult, human subjects.~   "
111013|NCT01603173|"~     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single~     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test~     Product and the corresponding Reference Product under fasting condition in normal, healthy,~     adult, human subjects.~   "
111014|NCT01603160|"~     The objective of this study is to design, implement and test quality improvement measures to~     improve the care of adults with sickle cell disease in the emergency department.~   "
111015|NCT01603147|"~     The primary objective is to determine the safety and tolerability of single, ascending~     intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse~     event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a,~     randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered~     ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will~     receive a single dose of ch-mAb7F9 or placebo (saline).~   "
111016|NCT01603134|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over comparative pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in normal, healthy, adult, human male subjects.~   "
111017|NCT01603121|"~     The primary goal of the study is to investigate the safety and tolerability of the~     investigational drug lisofylline, when administered under the skin or in the vein, in people~     with type 1 diabetes. A second aim is to determine how much drug is available in the blood~     after injection under the skin, compared to injection in the vein.~   "
111018|NCT01603108|"~     The purpose of this study is to determine if the administration of a poorly-absorbable~     antibiotic (rifaximin) for the first three months after liver transplant will reduce the~     amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent~     hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that~     comes from the bacteria in intestines and may cause scarring in the liver.~      Approximately 60 subjects will participate in this study. Subjects will be part of the study~     for approximately 1 year post transplant.~   "
111019|NCT01603095|"~     Multicenter, multinational study to collect consistent baseline growth measurements on~     pediatric patients with Achondroplasia being considered for subsequent enrollment in Study~     111-202. No study drug is administered.~   "
111020|NCT01603082|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS~     patients undergoing an Ad Hoc PCI~   "
111021|NCT01603069|"~     This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a~     blinded and randomized assignment. The main objective is to see if safety and tolerability~     of the drug is acceptable.~   "
111022|NCT01603056|"~     Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT~     HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with~     or without asthma.~      Sublingual immunotherapy has been used during several years and has been shown to provide~     benefits compare to traditional subcutaneous treatment. This study will investigate if~     improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as~     a consequence of being treated under specific immunotherapy.~      This study aim also to contribute to the documentation of tolerability and safety profile of~     Pangramin HDM Mix.~   "
111023|NCT01603043|"~     The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT)~     injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size~     change from baseline at Month 12.~   "
147588|NCT01122550|"~     The purpose of this study is to evaluate its reproducibility of overactive bladder symptom~     score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.~   "
111025|NCT01603017|"~     Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in~     osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to~     investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the~     knee joint.~      The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate~     oteoarthosis of the knee.~   "
111026|NCT01603004|"~     Sunitinib and everolimus are two new treatments approved in 2011 for patients with~     pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are~     often used to treat pancreatic NETs. Traditional chemotherapy is also known as cytotoxic~     therapy and works by killing cells that are actively dividing. There have been no studies~     to compare the different types of treatment. Since the patient is eligible for treatment~     with either sunitinib, everolimus or traditional chemotherapy it can help us identify~     factors that may help future patients benefit from these therapies.~   "
111027|NCT01602991|"~     This study aims to determine that this new technology, nasopharyngoendoscopy, is just as~     effective in diagnosing problems as the current gold standard.~   "
111028|NCT01602978|"~     The purpose of this study is to investigate whether a validated sensor that is able to~     measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and~     Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage~     how much fluid and possibly blood you need to get during your surgery. The hope of the study~     is that the device may provide an early indication you are having bleeding and this may mean~     you need to be treated with a transfusion. Our current method of checking this is by getting~     a blood sample for analysis. The investigators hope is that this device may be able to alert~     the clinician of the need for blood or fluids without a blood draw being needed.~   "
111029|NCT01602965|"~     The purpose of this study is to evaluate the most effectiveness between a personalized~     nutritional program with a counseling monthly phone call Versus personalized nutritional~     program with self help Informative Booklet in a group of obesity or overweight patients~     without counseling phone call.~   "
111030|NCT01602952|"~     A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic~     myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase~     inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of~     CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated~     phases.~      Phase 1~      1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of~     oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects~     who are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or~     intolerant to at least one second-generation targeted anticancer agent while being~     resistant, suboptimal responsive, or intolerant to imatinib simultaneously.~      Phase 2~        1. To investigate safety of oral Radotinib HCl in CML patients who are resistant or~          intolerable to imatinib in the chronic and accelerated phases.~        2. To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCl in CML patients~          who are resistant or intolerable to imatinib in the chronic and accelerated phases.~   "
111031|NCT01602939|"~     The aim of this study is to evaluate the efficacy in terms of clinical and biological~     response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with~     advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.~   "
111032|NCT01602926|"~     Hallux valgus is a common deformity of the big toe, defined as medial deviation of the first~     metatarsal bone along with lateral deviation of the first toe. Surgery has been shown to be~     beneficial when compared to orthotics or no treatment. While generally effective, surgery is~     associated with significant post-operative pain and disability, with several weeks of~     limited mobility. Minimally invasive techniques have the potential to lead to increased~     patient satisfaction while still achieving adequate correction of the deformity.~      This trial is a non-inferiority treatment study, with open-label, randomized, prospective,~     controlled, parallel experimental design, to compare the clinical and radiographic outcomes~     of a minimally invasive surgery versus a conventional surgery for hallux valgus. This trial~     examines two different surgical interventions. No drug or device is being evaluated in this~     trial.~      60 to 100 patients, over the age of 18 years, undergoing surgical correction of mild to~     moderate hallux valgus will be enrolled in the trial. The patients will be randomized to two~     groups, one treated with a conventional distal osteotomy surgery, the other treated with a~     minimally invasive surgery. Randomization will occur immediately prior to surgery via a~     multitude of opaque envelopes containing a coded group assignment. Due to the differences in~     the techniques, neither the investigator and the subject can be effectively blinded to the~     group assignment. Data collection for the outcomes measures will occur preop, and then post~     of at 2 weeks, 12 weeks, and at 1,2, and 3 years.~      The primary outcomes measure is the Manchester-Oxford Foot Questionnaire Score (MOXFQ).~     Manchester-Oxford Foot Questionnaire' (MOXFQ), a 16 item patient-reported questionnaire~     consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items)~     and 'Social interaction' (four items). The MOXFQ is a validated disease-specific outcomes~     scale for foot and ankle surgery which has been shown to be responsive and reliable.~      Secondary outcome measures are preoperative to postoperative change in hallux valgus angle~     (HVA). Radiographic outcomes parameters will be measured using weight-bearing radiographs to~     analyze preoperative and postoperative hallux valgus angle, and the correction or~     normalization thereof. (Degrees of correction = 2 week preoperative HVA - 12 week~     postoperative HVA.)~   "
111033|NCT01602913|"~     Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability~     to regulate glucose levels in the blood. Diabetes can cause many severe complications if not~     treated properly. Hyperglycemia is a regular effect of uncontrolled diabetes and can lead to~     complications such as cardiovascular disease, chronic renal failure, diabetic retinopathy~     and inability to maintain a healthy body weight.~      Cardiovascular Disease (CVD) is now the leading cause of death worldwide, affecting millions~     of people in both developed and non-developed countries. The buildup of cholesterol in the~     bloodstream may cause the excess to be deposited in the coronary arteries of the heart and~     the carotid arteries of the brain. The cholesterol deposits are a factor of the plaques that~     cause blockage of the arteries which can in turn lead to heart disease and stroke. By~     lowering the blood levels of cholesterol, risks of heart disease, strokes and heart attacks~     are reduced. Medications such as HMG-CoA reductase inhibitors and fibrates are useful in the~     prevention of CVD.~      Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase~     inhibitors, and is shown as an adjunctive therapy to diet. It is known to reduce the amount~     of cholesterol and other fatty substances in the blood. In addition, pravastatin is~     indicated to reduce the risk of myocardial infarction, revascularization and cardiovascular~     mortality in hypercholesterolemic patients who do not have clinically apparent coronary~     heart disease. The recommended starting dose for adults is 40 mg once daily. For patients~     who do not reach the LDL-C goal with 40 mg, it is recommended to use an 80 mg dose. For~     persons with significant renal impairment the recommended dose is 10 mg. Children aged 8-13~     years have a recommended starting dose of 20 mg daily. Adolescents aged 14 to 18 years have~     a recommended starting dose of 40 mg daily.~      Depression is known as the most common mental disorder and most prevalent type of mood~     disorder today. It can be seen as a state of mood, a symptom, a syndrome or as a clinical~     diagnosis. Depression is a common disorder, affecting about 121 million people worldwide.~     Depression is more likely to co-occur with medical illnesses such as stroke, heart disease,~     cancer and diabetes. Up to one-quarter of people with diabetes are estimated to experience~     depression which is two times more than those who do not suffer from diabetes. Studies have~     shown that major depression mainly occurs in 2¬4 percent of people in the community, in 5-10~     percent of primary care patients and 10-14 percent of medical inpatients. Also, recent~     studies have estimated that the symptoms continue over a 6 month to one year period in~     patients with major depression. The severity of the symptoms and the incidence of medical~     illness are expected to predict the persistence of depression. Depression can be treated~     effectively by a variety of antidepressants and/or psychotherapies. If treated~     appropriately, over 80 percent of people who suffer from depression can be helped.~      Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI)~     antidepressant. It was the first antidepressant that was formally approved in the United~     States for the treatment of panic attacks, major depression, post¬traumatic stress disorder,~     social anxiety, generalized anxiety disorder, panic disorder and obsessive-compulsive~     disorder. Paroxetine has a well-established safety profile and it shares the common side~     effects and contraindications of other SSRI's which include nausea and somnolence and is~     associated with weight gain.~      This study proposes to conduct a retrospective cohort study to assess the risk of new onset~     diabetes among patients undergoing treatment with Pravastatin or other statins, and~     Paroxetine or other SSRI's. This study will compare the risk of co administration of two~     drug classes versus the use of each agent alone. In addition, the risk among patients~     prescribed Paroxetine and fibrates in combination, relative to the use of Paroxetine singly,~     will be examined to determine whether any interaction found between Paroxetine and statins~     extends to other drugs indicated for hypercholesterolemia.~      The first primary objective of the study is to estimate the incidence of Type 2 Diabetes~     (T2DM) among patients newly exposed to pravastatin in combination with paroxetine, or other~     SSRIs, compared to those newly exposed to pravastatin alone. The second primary objective is~     to estimate the incidence of Type 2 Diabetes (T2DM) among patients newly exposed to~     paroxetine in combination with pravastatin, other statins, or fibrates, compared to those~     newly exposed to paroxetine alone.~   "
111034|NCT01602900|"~     This study will investigate if a new experimental drug to treat Huntington's Disease gets~     into the brain. If it does get into the brain the study will explore the relationship~     between the amount of drug in the brain and the amount of drug in the blood. The study will~     involve healthy male volunteers.~   "
111035|NCT01602887|"~     This is a BA study comparing the bioavailability of two new capsule formulations and one~     solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy~     volunteers.~   "
111036|NCT01602874|"~     The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone~     regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal~     infections (cIAI) and community acquired pneumonia (CAP).~   "
111037|NCT01602861|"~     The purpose of this study is to assess whether the diuretic drug spironolactone can prevent~     chronic damage to transplanted kidneys caused by the medication that prevents rejection.~      Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of~     being involved in the processes leading to chronic rejection of transplanted kidneys. Hence,~     by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function~     in transplant patients.~   "
111101|NCT01602029|"~     Negative symptoms and cognitive deficits are two partially-related features of schizophrenia~     which have a major negative impact on social function and objective quality of life.~     Standard drug treatments have little impact on either and arguably no effect on primary~     negative symptoms. Social dysfunction has major economic consequences in both the developed~     and developing world. There is evidence that anti-inflammatory treatment may have beneficial~     effects in patients with schizophrenia.~   "
111038|NCT01602848|"~     Medicaid-insured patients with frequent hospitalizations account for a disproportionate~     share of visits and costs, and have caught the attention of policy makers, creating an~     impetus for hospitals and health care providers to better understand and control associated~     expenditures. Many such patients have specific unmet health and social needs. Based on our~     extensive pilot work with this population, the New York State Department of Health recently~     awarded the New York City Health and Hospitals Corporation one of seven statewide contracts~     to implement a Chronic Illness Demonstration Project, aimed at improving care and reducing~     healthcare expenditures for high cost Medicaid patients. Within this framework, the~     investigators propose a group-randomized trial design to test whether specific outcomes~     related to health, functional status, and quality of life resulting from a patient-centered,~     intensive care coordination and management intervention correlate with improved linkage to~     primary care while reducing hospitalizations and emergency department visits. The~     investigators will then relate these benefits to program costs using standard~     cost-effectiveness analysis techniques. Given that there are few examples of successful~     interventions for this population and currently unparalleled Medicaid spending, there is an~     urgent need to demonstrate that interventions to improve care coordination and optimize~     patients' use of the health and social care system result in more efficient and less costly~     care.~   "
111039|NCT01602835|"~     This is a prospective cross-sectional, observational, single-center study of Alport~     patients, in which a single, first morning voided urine collection will be acquired and used~     to validate assays of urine biomarkers that reflect changes in glomerular protein filtration~     barrier function.~      The purpose of this study is to identify biomarkers indicative of changes in glomerular~     filtration function that occur during the course of proteinuric renal diseases such as~     Alport nephropathy.~   "
111040|NCT01602822|"~     This study will evaluate how safe and tolerable a combination of taking three-drugs will be~     for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in~     HIV uninfected adults.~   "
111041|NCT01602809|"~     Background:~      - Small blood vessels (microvessels) in many different organs are affected by diseases such~     as diabetes and atherosclerosis. These microvessels may also be abnormal in people who have~     sickle cell disease. Stiffness of the red blood cells leads to problems in the microvessels~     of the heart and kidneys. However, these problems may not be detected until these organs are~     severely affected. Researchers want to study problems with microvessels in people with and~     without sickle cell disease.~      Objectives:~      - To study how microvessels in the heart and other organs are affected by sickle cell~     disease.~      Eligibility:~        -  Individuals at least 18 years of age who have sickle cell disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have about 3 to 4 hours of testing for the study. Participants~          with sickle cell disease who are having a pain crisis at the time they enter the study~          may be asked to have the testing again when the crisis is over. The repeat testing will~          occur at least 4 weeks after the pain crisis ends.~        -  All participants will have the following tests:~        -  Blood draws to check kidney and liver function, and other blood tests~        -  Measure of blood flow in the brachial (upper arm) artery~        -  Heart ultrasound~        -  Ultrasound scans of arm muscles to study blood flow~        -  Ultrasound scans after taking vasodilators to increase blood flow~        -  Healthy volunteers will also have a magnetic resonance imaging scan. It will show blood~          flow in the heart. This scan will involve another dose of a vasodilator.~   "
111042|NCT01602796|"~     In this multicenter cluster randomized controlled trial stratified by school baseline~     prevalence of smoking will be randomly allocated to the control or intervention group.~     Control schools will receive normal smoking education and intrvention schools will receive a~     four year class-based curriculum intervention (22 Classroom lessons), reinforcement of~     smoke-free school policy, smoking cessation in parents, pupils, and teachers and information~     and annual meeting with parents.~      Study participants will be children aged 12 to 15 years old ; they will be followed to 2~     years after high school. External evaluator and analyst will be blinded to school~     allocation.~      The aim of this study is to analyze the effectiveness of a complex intervention to reduce~     the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18~     yrs-old) .~   "
111043|NCT01602783|"~     This research is being conducted to test an imaging technique that may be able to detect~     small amounts of prostate cancer that can not be detected by standard imaging.~      Many patients who are diagnosed with prostate cancer undergo surgery to remove the prostate.~     After this surgery, some patients have a PSA blood test that reveals a low but detectable~     level of PSA. This PSA may be produced by cancer cells in one of two locations: (1) near the~     area where the prostate used to be, or (2) elsewhere in the body. If the cancer is only in~     the area where the prostate used to be, it can be successfully treated with radiation to~     that area. If the cancer is elsewhere, radiation is not helpful. Currently, there is no~     available scan that can detect cancer when the PSA is still so low.~      The test used in this study is called [11C] acetate PET screening. [11C] acetate is a~     radioactive tracer that is given by vein to patients before PET scanning. The PET scanner~     then detects radioactivity from the tracer that is attached to cells within your body and~     uses this information to create images (pictures) on a computer screen.~      [11C] acetate PET scanning has been shown in early studies to detect smaller amounts of~     prostate cancer that can be detected by standard imaging tests such as CT scan and bone~     scan. If it is successful at detecting very small amounts of prostate cancer, [11C] acetate~     PET scanning will help doctors identify patients who will benefit from radiation therapy~     after their prostate has been surgically removed. It will also help them identify patients~     who have small amounts of prostate cancer in other parts of the body and will not benefit~     from radiation to the prostate area.~      This type of PET scan is investigational. Investigational means that the scan is still~     being studied and that research doctors are trying to find out more about it. It also means~     that the FDA has not approved this type of PET scan for your type of cancer. The information~     collected by this scan will determine whether this type of scanning is helpful but it will~     not be used to make decisions about your medical care.~   "
111057|NCT01602601|"~     Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients~     who are currently being treated with idursulfase, an enzyme replacement therapy, and in at~     least a single patient who is naïve to treatment, if possible to recruit. All patients~     enrolled into the study will have a single blood draw for the analysis of antibodies induced~     by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to~     antibodies induced by idursulfase will be used to further evaluate whether the antibodies~     induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies~     neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit,~     which may occur at their regularly scheduled out-patient visit. If the patient consents to~     participate in the study, a blood sample (total volume of approximately 3mL) for~     immunogenicity analysis will be drawn before their current treatment infusion~   "
111044|NCT01602770|"~     Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being~     the first oral contraceptive delivering estradiol. It has been recently approved in Mexico.~     To evaluate the clinical profile of this drug combination under routine medical condition, a~     post-authorization safety study required by Mexican Health Authorities will be conducted in~     Mexican women.~      The study will be performed as a descriptive study, no hypothesis will be tested. The cohort~     consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical~     conditions. Subjects should provide all necessary information on health-related events or~     changes in health status during Qlaira use.~      Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or~     not related to Qlaira during at least 2 years of observation.~      In order to comply with the criteria of a non-interventional study, women only will be~     informed about the study, asked to participate and included in the study after Qlaira has~     been prescribed.~      Study patients follow-up will be done in accordance with common clinical practice as~     described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM~     005-SSA2-1993).~   "
111045|NCT01602757|"~     This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-,~     and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without~     heat.~   "
111046|NCT01602744|"~     The purpose of this study is to determine if the use of STOPP/START criteria~     (STOPP-screening tool of older persons potentially inappropriate prescriptions~     START-screening tool to alert doctors to right treatment)for medication intervention in~     elderly population living in a geriatric hospital will lower the number of~     falls,hospitalization,will improve functioning, quality of life and reduce financial costs.~   "
111047|NCT01602731|"~     Trialing an automated medication dispensing device (AMDD) to improve medication adherence in~     patients with heart failure.~   "
111048|NCT01602718|"~     This study will compare physical activity levels and physical functioning in patients~     treated with home dialysis vs. those treated with in-center dialysis. The investigators will~     first compare prevalent patients, and will also compare the two groups longitudinally in~     incident patients over the first 18 months of beginning the dialysis treatments. Patients~     will be tested for physical functioning using standard performance-based testing such as~     gait speed, chair stand, balance test, as well as self-reported limitations in activities of~     daily living. The investigators will monitor physical activity using step counters and~     activity questionnaires. Blood samples will be drawn at each testing time to measure~     inflammatory markers. A pilot study of home dialysis patients will be done to determine the~     effects of an independent home-based exercise program on physical functioning and~     inflammatory markers. For this pilot study, 30 patients will be randomized into exercise~     intervention and usual care with testing at baseline and again after 3 months of the~     intervention.~   "
111049|NCT01602705|"~     We hypothesise that feedback and feedback + psychology informed intervention delivered to~     primary care medical practices will reduce high-risk prescribing to patients compared to a~     simple educational intervention alone. The specific objectives are :~        1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified~          primary outcome of a composite measure of high-risk antipsychotic, non-steroidal~          anti-inflammatory drug, and antiplatelet drug prescribing~        2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified~          secondary outcomes of the six individual measures constituting the composite~        3. To assess the cost-effectiveness of the intervention~   "
111050|NCT01602692|"~     The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent~     solution containing both dilute lidocaine and epinephrine will lead to better control of~     postoperative pain, nausea, vomiting, shorter time through postoperative phases of care,~     quicker discharge from the hospital and lower numbers of hospital readmissions than the use~     of tumescent solution containing only dilute epinephrine.~   "
111051|NCT01602679|"~     The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in~     women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency~     within 10 hours. The investigators propose to assess this further with a randomized,~     cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will~     be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10~     hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone.~     Either oral micronized progesterone suspension or placebo will be administered at 0900 h.~     During a subsequent menstrual cycle, subjects will undergo another study identical to the~     first except that oral progesterone will be exchanged for placebo or vice versa in~     accordance with a crossover design.~   "
111052|NCT01602666|"~     Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy~     with radiation therapy may kill more tumor cells. This phase II trial studies how well~     chemotherapy and radiation therapy work in treating younger patients with newly diagnosed~     central nervous system germ cell tumors.~   "
111053|NCT01602653|"~     The purpose of this study is to compare two different ranges of energy flux density with~     Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.~   "
111054|NCT01602640|"~     Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and~     extubation, as compared to the combination of fentanyl and midazolam in critically-ill~     patients.~   "
111055|NCT01602627|"~     This phase I trial studies the side effects and best dose of Hsp90 inhibitor AUY922 in~     treating older patients with advanced solid malignancies. Hsp90 inhibitor AUY922 may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth~   "
111056|NCT01602614|"~     This is a clinical sampling study, and no study drugs will be administered under this~     protocol. Premature infants who receive intravenous ganciclovir as part of clinical care~     will be eligible for participation in this study. Intravenous ganciclovir will not be~     provided under this protocol.~   "
111058|NCT01602588|"~     There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the~     prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve~     survival outcome in a variety of cancers including HGG, with few side effects.~      In this trial the investigators wish to investigate whether treatment with radiotherapy and~     hydroxychloroquine is more effective than treatment with radiotherapy alone.~   "
111059|NCT01602575|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate~     brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training~     on these measures. The goal of this study is to identify biomarkers of IBS and assess the~     responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is~     in general a substance or measure used as an indicator of a biological state. It is a~     characteristic that is measured and evaluated as an indicator of normal biological~     processes, disease processes, or responses to a therapeutic intervention, in this case MBSR.~   "
111060|NCT01602562|"~     The purpose of this study is to evaluate the preventive efficacy for HSV infection and~     safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.~   "
111061|NCT01602549|"~     Gastric emptying is the end-result of a complex and carefully regulated series of events~     which follow the ingestion of a meal, each of which is dependent on the other and subject to~     neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum,~     whose physiological action is mediated by motilin receptors located on enteric neurons,~     peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and~     non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore~     provide a potential approach to the treatment of a range of clinical conditions in which~     delayed gastric emptying is thought to be part of the physiopathology and may be~     contributory to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative~     disorder characterized by degeneration of nigrostriatal dopaminergic neurones. It affects~     1.5% of the global population over 65 years of age. Cardinal symptoms comprise bradykinesia,~     rigidity, resting tremors and postural instability. Gastrointestinal dysfunction, including~     gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is~     caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug~     therapy. The therapeutic mainstay for PD treatment is the neutral amino acid~     L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and~     effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA~     bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its~     proximal small intestinal absorption sites, increasing the extent of presystemic metabolism,~     and leading to slowed and diminished absorption.~   "
111062|NCT01602536|"~     In Phase I (N=40), we developed a treatment protocol for smoking cessation and relapse~     prevention that used virtual quit-smoking Twitter groups and Twitter-enabled interactive~     peer messaging. We tested and refined this protocol using two quit-smoking Twitter groups.~     In Phase II (N=160), we conducted a two-arm (test vs. control) randomized controlled trial~     of the treatment protocol created in Phase I. In Phase III (N=80) we ran additional~     quit-smoking Twitter groups and tested various interventions to increase engagement in the~     intervention, e.g., peer leaders. This research provided crucial data about the viability~     and methodology to be used in a larger randomized controlled trial that would directly~     measure smoking behavior.~   "
111063|NCT01602523|"~     This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an~     inhaled medication that contains 2 drugs. One is a medication that opens up the airways~     (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort~     is not an experimental medication. It is approved by the Food and Drug Administration for~     use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The~     cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by~     opening the airways and reducing lung inflammation. It is not known for sure if these~     effects actually improve sleep and quality of life. It is hoped that this study will answer~     this question.~   "
111064|NCT01602510|"~     This registration study in China is a multi-centre, double-blind, placebo-controlled~     clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of~     recurrence/relapse of mood episodes in subjects with bipolar I disorder. Subjects are~     bipolar I disorder patients with recent/current manic, hypomanic, mixed or depressive~     episode. The study will include an open-label phase and a randomized phase. During the~     open-label phase, subjects will have lamotrigine monotherapy or combination therapy~     escalation. The target dose of lamotrigine is 200 milligram (mg)/day monotherapy. The~     duration of treatment in the open-label phase will last 6-16 weeks, until subjects reach a~     stable dose of lamotrigine. Beginning at week 7 of the open-label phase, subjects who have~     reached a stable dose of lamotrigine and met response criteria, defined as maintaining a~     Clinical Global Impression of Severity (CGI-S) score <= 3 for at least 4 continuous weeks~     and maintaining lamotrigine 200 mg/day monotherapy for at least 1 week, will be eligible to~     enroll in the double-blind phase of the study. Subjects who have not met response criteria~     after 16 weeks of participation in the open-label phase will be withdrawn from the study.~     Subjects will have lamotrigine 200 mg/day monotherapy for at least 1 week prior to~     randomization. Subjects who have met randomization requirements will be randomized 1:1 to~     lamotrigine 200 mg/day or placebo for 36 weeks double-blind treatment. After randomization,~     subjects will be assessed at weekly intervals for the first month, biweekly intervals for~     the second month, and then at monthly intervals for up to 36 weeks of double-blind~     treatment. The primary endpoint will be TIME, defined as the time to intervention (addition~     of pharmacotherapy or electroconvulsive therapy [ECT]) for any mood episode (relapse or~     recurrence of a depressive, manic, hypomanic or mixed episode) after randomization. The~     secondary endpoints will include time to intervention for manic, hypomanic or mixed episode~     (TIMan) and time to intervention for depressive episode (TIDep).The scores on the Hamilton~     Depression (HAMD), Young Mania Rating Scale (YMRS), CGI-I, CGI-S and Global Assessment Scale~     (GAS) will be used as indicators for both intensity and duration of mood symptoms during~     this phase. Subjects who withdraw early from the study prior to week 36 or reach TIME will~     have a follow-up visit 14 days after the last dose of investigational drug.~   "
111065|NCT01602497|"~     This study is going to evaluate the effects of repetitive transcranial magnetic stimulation~     (rTMS) on Borderline Personality Disorder patients symptoms.~   "
111066|NCT01602484|"~     The investigators wish to perform a randomized controlled study to determine how much time~     and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint~     packs compared to bulk supplies.~   "
111067|NCT01602471|"~     This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for~     carotid plaque imaging and will be conducted as a Phase II trial since this compound has~     already been tested in humans for phase I and phase II imaging. All study results will be~     evaluated and analyzed in order to consider the design for future clinical trials.~   "
111068|NCT01602458|"~     The study's objective is to compare the global scar outcomes in those treated with silicone~     only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of~     hypertrophic scarring in children with skin grafts after traumatic skin injury.~   "
111069|NCT01602445|"~     The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases~     their quality of life, delays their treatment and may cause death. The best way to avoid new~     clots is by giving blood thinners before clots are formed, but even some patients who are~     taking blood thinners may form blood clots. A major problem is that it is difficult to know~     which patients form clots while they are receiving blood thinners, a situation called~     treatment failure. Several studies have shown that by doing blood tests that measure the~     formation of clots, the investigators could know if the patient is responding to the blood~     thinners. If this is proven, the investigators will be able to apply these tests to all~     patients.~   "
111070|NCT01602432|"~     Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli)~     which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays~     cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients~     without blood clots. Blood thinners may prevent clots but major bleeding is also a problem,~     so preventive therapies are not used routinely. Identifying patients at highest risk for~     clots is critical. A tool exists but it has not been used outside of research. We propose to~     study how to apply this tool in clinical practice and test if it works.~   "
111071|NCT01602419|"~     This is an observational study, hence there is no study hypothesis~   "
111072|NCT01602406|"~     This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum~     Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in~     combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2~     (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study~     consists of a dose escalation part and a dose expansion part. LJM716 will be administered~     intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or~     once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing,~     administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15~     patients are anticipated to be treated in successive cohorts. The dose escalation will~     continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a~     dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD)~     considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients~     will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to~     further assess the safety, tolerability, and anti-tumor activity of the combination.~   "
111073|NCT01602393|"~     The purpose of the study is to evaluate the safety and tolerability of ascending oral doses~     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.~   "
111074|NCT01602380|"~     The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or~     Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or~     metastatic breast cancer who have not had prior hormonal treatment.~   "
111075|NCT01602367|"~     The purpose of this study is to determine whether BMS-823778 is safe and effective in the~     treatment of hypertension in overweight and obese patients.~   "
111076|NCT01602354|"~     The purpose of this observational study is to determine whether endotoxin levels and/or~     their trends can be considered predictive of morbility or mortality in septic shock caused~     by gram-negative bacteria, searching also for a possible correlation with Simplified Acute~     Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells~     (WBC) and Platelets (PLT).~   "
111077|NCT01602341|"~     The purpose of this study is to determine the safety and efficacy of AN2728 Topical~     Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment~     of adolescents with atopic dermatitis (AD)~   "
111078|NCT01602328|"~     Subjects entering the study will have undergone cardiac surgery. Those who experience kidney~     injury within 48 hours of their surgery will be enrolled into the study. Once enrolled,~     subjects will receive a single administration of AC607 or placebo. Kidney recovery will be~     evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated~     within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year~     extension phase of the study to monitor safety and long-term outcomes (follow-up period).~   "
111079|NCT01602315|"~     This is a multi-center, open-label, Phase Ib dose escalation / Phase II study in recurrent~     or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be~     resistant, ineligible or intolerant to platinum-based chemotherapy. The first aim of the~     Phase Ib is to determine the Maximum Tolerated Dose(s) (MTD(s)) and/or the Recommended Phase~     II Dose(s) (RP2D(s)) for BYL719 in combination with cetuximab This part will include two~     different arms using two different administration methods of BYL719 tablets together with~     cetuximab as recommended by the label: Arm A - whole tablets will be administered to~     patients able to swallow the tablets vs. Arm B - a drinkable suspension prepared from~     crushed tablets will be administered to patients with swallowing dysfunction. The second aim~     of the Phase Ib is to compare the pharmacokinetics (PK) of the new dispersible tablet~     formulation of BYL719 in combination with cetuximab. A third arm will be opened: Arm C,~     which will use a suspension from a dispersible tablet administered via gastric feeding tube~     (G tube). The safety, tolerability, PK, PD, and efficacy will be investigated separately in~     the Phase Ib arms. The MTD/RP2D will only be investigated independently for Arm A and B. The~     one of Arm B will be compared to that of Arm A. If the MTD/RP2D is the same, then both~     administration methods of BYL719 may be used in Phase II. If the MTD/RP2D is different, then~     only the administration of BYL719 whole tablets will be allowed in the Phase II. Arm C is an~     independent relative bioavailability study of the new dispersible tablet formulation of~     BYL719, which will begin at the starting dose/RP2D identified with a safety cohort followed~     by an expansion cohort. There will be no dose escalation or de-escalation in this Arm. If~     either the safety or pharmacokinetic profile of the RP2D of 300 mg QD in Arm C is not~     comparable with Arm A, then enrollment in Arm C will cease and the dispersible tablet will~     not be implemented in Phase II.~      The Phase Ib dose escalation part is expected to enroll approximately 12 patients for Arm A~     and B and will be guided by a Bayesian logistic regression model (BLRM). The available~     safety, tolerability, PK, PD and efficacy data, as well as the recommendations from the~     BLRM, are used to determine the dose combination for the next cohort(s). The Phase II part~     of the study will commence upon MTD/RP2D declaration of Arm A in Phase Ib, regardless of the~     progress of Arm B and C.~      The Phase II part will assess the clinical efficacy of BYL719 in combination with cetuximab~     in two patient populations: patients will be assigned to one of two schemes of enrollment~     based on prior therapy with cetuximab.~      Patients considered cetuximab naïve per protocol will be assigned to Scheme 1. The primary~     purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination with~     cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2) in RM HNSCC patients' naïve to~     cetuximab. Patients in scheme 1 will be randomized in a 2:1 ratio via IRT in two Phase II~     arms: BYL719 in combination with cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2).~     Patients randomized to Arm 2 (cetuximab monotherapy) will have the opportunity to cross-over~     to combination treatment with BYL719 + cetuximab after experiencing disease progression. Arm~     1 will consist of approximately 66 patients and Arm 2 of approximately 33 patients.~      Patients having received prior cetuximab per protocol will be assigned to Scheme 2. The~     primary purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination~     with cetuximab in RM HNSCC cetuximab resistant patients (Arm 3). Patients in this scheme~     will not be randomized. 40 patients will be enrolled. Phase II will further characterize the~     safety and PK of the drug combination.~      Patients will be treated until progression of disease (except for phase II Arm 2),~     unacceptable toxicity, or withdrawal of informed consent, whichever occurs first. Patients~     enrolled in Arm 2 experiencing disease progression will have the opportunity to crossover to~     the combination treatment (Arm 2B) and they will continue until they experience unacceptable~     toxicity that precludes any further treatment, until disease progression, and/or until~     treatment is discontinued at the discretion of the Investigator or by patient refusal. In~     the follow-up period all patients must complete the safety follow-up assessments 30 days~     after the last dose of the study treatment. Patients who have not progressed at the time of~     discontinuation of study treatment should be radiologically followed for disease status~     until disease progression, initiation of subsequent anticancer therapies, or death,~     whichever occurs first. In addition, all patients enrolled in Phase II will be followed for~     survival.~   "
111080|NCT01602302|"~     biological DMARDs may be stopped in Rheumatoid Arthritis (RA) patients treated with a~     combination of synthetic DMARD plus bDMARDs which are in persistent clinical remission. The~     research question of this study is, whether musculoskeletal sonography is a useful biomarker~     predicting a disease flare after cessation of bDMARD therapy.~   "
111081|NCT01602289|"~     The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese~     participants with cancer that is advanced and/or may have spread to another part of the~     body.~   "
111082|NCT01602276|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain abilities related to cognition, emotion and/or physical~     functioning in individuals with subcortical brain damage.~   "
111083|NCT01602263|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities. In this research, battery powered device is~     used to deliver very weak electrical current to the surface of the scalp while participants~     complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance~     in both healthy adults and those with neurological impairment.~   "
111084|NCT01602250|"~     The systemic toxicity of local anaesthetics may be treated using lipid emulsions (lipid~     rescue). However, there is no evidence-based proof of the efficacy of the treatment. The~     aim of the intended protocol is to study the effect of the emulsion Intralipid® on the~     toxicity prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a~     sensitization session with lidocaine, subjects will receive in a double blind, crossover~     manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of~     Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of~     toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be~     performed in order to evaluate the changes in pharmacokinetics induced by the emulsion.~   "
111085|NCT01602237|"~     The study is a follow-up of investigations done in the years 1999-2002 in bakery employees.~     The main purposes are to look at the associations between flour dust exposure and~     respiratory disease, and to find out the best ways to reduce the flour dust levels in the~     working environment.~   "
111086|NCT01602224|"~     The purpose of this study is to evaluate an investigational drug called tabalumab in~     participants with Multiple Myeloma (MM) who have tried at least one other therapy in the~     past. Tabalumab will be given in combination with standard doses of two other drugs that are~     often used to treat MM. Study doctors will collect information about the effectiveness and~     side effects of this therapy.~   "
111098|NCT01602068|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis~     with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation~     of a posterior chamber intraocular lens.~   "
111087|NCT01602211|"~     This randomized clinical trial studies an internet and social-media program for improving~     quality of life in long-term survivors who underwent stem cell transplant. In this study,~     researchers want to compare a survivorship internet program to the standard treatment of~     currently available internet sites for transplant survivors to learn which works better for~     people who have received bone marrow or blood stem cell transplants. A survivorship-focused~     internet program may improve mood, stress, and preventive health care, and provide useful~     health resources for transplant survivors. It is not yet known whether currently available~     internet sites are more effective than a survivorship-focused internet program in improving~     quality of life in cancer survivors.~   "
111088|NCT01602198|"~     The goal of this project is to determine if task-activated fMRI is sensitive to the central~     cholinergic deficit associated with Mild Cognitive Impairment.~   "
111089|NCT01602185|"~     The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to~     ketamine maintains or induces a decrease of pain intensity.~      In clinical, after ketamine cure, clinicians have often difficulties to treat patients in~     order to maintain analgesia or suggest another treatment if analgesia induced by ketamine~     was not effective, which occurs in one quarter of patients. It will be very useful for~     monitoring of painful patients evaluate if memantine or dextromethorphan could be an~     effective therapeutic alternative in neuropathic pain treatment.~   "
111090|NCT01602172|"~     Veterans drink, binge drink, and drive under the influence of alcohol at higher rates than~     non-Veterans do. Addressing alcohol misuse, the range of alcohol consumption from risky~     drinking to alcohol abuse and alcoholism, is a national priority for the VA. It is~     recommended that people keep their alcohol consumption below limits established by the~     National Institutes of Health (NIH). A type of 10-15 minute counseling known as brief~     intervention (BI) has been shown to help risky drinkers cut back to the NIH-recommended~     limits. This study will examine the impact of a nurse-delivered alcohol BI on hospitalized~     Veterans' weekly number of drinks, monthly number of binge drinking episodes, readiness to~     change drinking behavior, and alcohol-related problems. This preventative approach for~     reducing alcohol consumption is intended to help Veterans avoid many of the physical and~     psychosocial consequences of alcohol misuse.~   "
111091|NCT01602159|"~     This is a prospective randomized controlled trial to compare clinical improvement, cost~     effectiveness and patency rates between new and improved Nitinol stents and open bypass~     surgery in the superficial femoral artery disease.~      Secondary outcomes also include comparing quality of life, re-intervention rate, mortality,~     morbidity and time to return to work or regular activities.~      Patients with superficial femoral artery lesions will be considered. Patients with TASC II A~     lesions will not be randomized but treated with PTA/stenting as standard of care. Patients~     with TASC II B and C lesions will be prospectively randomized into either receiving open~     bypass or stenting.~      Patients with TASC D lesions will be treated with open bypass surgery after angiography.~      The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on~     all enrolled the patients.~   "
111092|NCT01602146|"~     Acute physiological consequences of ultramarathon running are still unknown, particularly in~     women. Results from the investigators first studies conducted in 2009 have shown that a~     large part of fatigue induced by a mountain ultramarathon could be attributed to central~     fatigue. The investigators have investigated the biological consequences and neuromuscular~     fatigue only in male runners. Data from the literature suggest that amplitude and etiology~     of fatigue after prolonged exercise might be gender-dependant.The main purpose of the~     present project is thus to quantify supraspinal central fatigue and associated changes in~     cortical excitability after an extreme exercise such as a mountain ultramarathon: the~     Ultra-Trail du Mont-blanc, by using TMS.~   "
111093|NCT01602133|"~     Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous~     catheter during a period of seven days.~   "
111094|NCT01602120|"~     This extension to study CFD4870g (GX01456) will assess the long-term safety and tolerability~     of repeated intravitreal administration of FCFD4514S in patients with geographic atrophy.~     Patients are eligible to participate who have completed the 18 month treatment assignment~     for study CFD4870g (GX01456), and meet GX28198 eligibility criteria. The anticipated time on~     study treatment is 18 months.~   "
111095|NCT01602107|"~     Urinary incontinence (UI) affects up to 50% of adult populations and stress urinary~     incontinence (SUI) is the most common form of UI, accounting for approximately 60% of~     patients. Women are affected by SUI much more often than men. Urine leakage in women with~     SUI occurs on exertion or during tasks that increase pressure on the bladder such as~     sneezing or coughing. SUI has been shown to be a barrier to physical activity in women, and~     as such can contribute to the development of diseases and disorders associated with~     inactivity.~      SUI appears to have many contributing factors such as structural damage (eg. tears in the~     pelvic organ supporting tissues), muscle weakness related to nerve injury or aging, or~     thinning of the urethral wall and/or its surrounding muscular sphincters. Currently the most~     common treatments for SUI are conservative therapy, which normally takes the form of~     exercise therapy provided by specialized nurses or physical therapists, and surgery, which~     is aimed at enhancing urethral support. Exercise therapy is effective, resulting in complete~     cure in 50% of cases, and surgery is effective for approximately 80% of patients but carries~     risks such as the development of urinary retention. It is currently not clear which~     treatment approach is better for which women.~      Through the proposed research, the investigators aim to determine how to predict which~     patients will improve or be cured with exercise therapy such that surgery can be avoided.~     Specifically the investigators will determine what is different between patients in whom~     exercise therapy succeeds and in whom exercise therapy fails. The investigators will also~     determine whether physiotherapist-supervised training of the pelvic floor muscles before~     surgery improves surgical outcomes. The proposed research will enable us to better~     understand the female continence system and how it responds to physiotherapeutic~     intervention. It will help us to develop improved assessment procedures that can streamline~     patient management.~   "
111096|NCT01602094|"~     Prevalence of participants who have protective immunity to measles virus is less than ninety~     percent.~      Predictor of adequate measles antibody levels include the following :~        -  History of measles infection~        -  History of complete measles primary immunization( 2 doses with at least 1 month~          interval after age of 9 months)~        -  History of measles exposure~      Predictor of inadequate measles antibody levels include the following :~        -  Born outside Thailand~        -  History of staying outside Thailand for long time in childhood~        -  Living in the rural area for a long period in childhood~        -  Fail to participate school system on time~   "
111097|NCT01602081|"~     The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of~     fistula closure in patients with persistent trans-sphincteric anal fistula who receive the~     Biodesign® Tissue graft as part of their LIFT procedure.~   "
111102|NCT01602016|"~     Researchers at Arkansas Children's Hospital Research Institute are conducting a study~     looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language~     impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment~     (there is no compensation for this visit). If language impairment is verified in the phase 1~     screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12~     weeks of folinic acid or an inactive placebo, in addition to several evaluations of your~     child's abilities and a single blood test. Children that complete phase 2 will be eligible~     for a 12 week open-label trial of folinic acid which is phase 3.~   "
111103|NCT01602003|"~     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group~     study The study was divided into three parts: part 1 was a screening period started with an~     initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during~     which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25~     mg bid (twice daily), or LC15-0444 50 mg qd groups and received the assigned treatment for~     24 weeks; part 3 was for those patients who completed part 1 & 2 and consented to receive~     another 28 weeks of treatment with LC15-0444 50 mg qd.~      Screening tests were performed on the patients who had given the written informed consent.~     After 2-week exercise/diet program according to the generally recognized guideline, eligible~     patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of~     24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18,~     and 24. Completing double-blind treatment for 24 weeks, each patient was asked to provide~     consent to participate in the part 3 of the study where all the patients were to receive~     LC15-0444 50 mg once daily. During 28-week treatment period of the part 3, each patient~     visited the study~   "
111104|NCT01601990|"~     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group~     study The study was divided into three parts: part 1 was started with an initial 2 weeks of~     exercise/diet program followed by another 2 weeks of single-blind placebo run-in period;~     part 2 was a double-blind treatment period during which eligible patients were randomized to~     LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3~     was for those patients who completed part 1 & 2 and consented to receive another 28 weeks of~     treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given~     the written informed consent. After 2-week exercise/diet program according to the generally~     recognized guideline, patients took placebo for another 2 weeks while continuing~     exercise/diet program. When the 2-week placebo run-in period was completed, eligible~     patients were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the~     total of 24- week treatment period of part 2 after randomization, each patient visited the~     investigational site at Week 6, 12, 18, and 24. Completing treatment with placebo or~     LC15-0444 50mg for 24 weeks after randomization, each patient was asked to provide consent~     to participate in the part 3 of the study where all the patients were to receive LC15-0444~     50mg regardless of the treatment received during the part 2 of the study. During 28-week~     treatment period of the part 3, each patient visited the investigational site at Week 30,~     38, 46, and 52. Total study period from screening was 56 weeks per each patient.~   "
111105|NCT01601977|"~     COPD continues to be a cause of major morbidity for patients. Those patients who also have~     respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and~     death and have worse health related quality of life than similar COPD patients without~     respiratory failure.~      Treatment options in this group of patients have been limited and data to support the use of~     machines to assist breathing (non-invasive ventilators) in stable patients are limited. A~     major limitation of these devices has been patient acceptance and achieving sufficient~     control of sleep breathing disturbance.~      Currently devices are set at a fixed pressure to support the breathing throughout the night.~     The new software within the trial device will aim to better match the support provided by~     the machine to that needed by the patient. It is hoped that this may offer enhanced comfort~     as well as superior control of respiratory failure.~   "
111106|NCT01601964|"~     The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and~     change in patient with ectopic pregnancy who needs to surgical treatment.~      Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be~     included in the study. This is an observational study.The plasma Vascular Endothelial Growth~     Factor level will be measured first day and two day after the diagnosis of ectopic~     pregnancy.~   "
111107|NCT01601951|"~     The purpose of this study is to determine if Bone Marrow Concentrate may be successful in~     the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of~     cells that has been shown to have regenerative properties. This study is designed to~     evaluate the short-term clinical and x-ray outcomes of injections for hip and knee~     osteoarthritis.~      Inclusion Criteria:~        -  Subjects must be scheduled for an autologous bone marrow hip or knee injection~        -  Subjects must have a diagnosis of hip or knee osteoarthritis~        -  Subjects must be between the ages of 18 and 85~        -  Subjects must be willing and able to sign Informed Consent~        -  Subjects must be willing and able to return for scheduled follow-up evaluations~      Exclusion Criteria:~        -  Subjects who have had any type of visco-supplementation in the treated joint within the~          last three months prior to enrollment~        -  Subjects for whom baseline data is not available~   "
111108|NCT01601938|"~     This study will be performed to determine whether selenium replacement reduces 28-day~     mortality of severe sepsis and septic shock patients, and to investigate whether selenium~     replacement contributes differently to the mortality reduction of the patients according to~     their initial serum selenium level.~   "
111109|NCT01601925|"~     Stellate ganglion block targets are C6 transverse process or C7 transverse process in~     anterior paratracheal approach which is most popular method. Cricoid cartilage is known that~     it is located at C6 level in supine neutral position of the neck. But stellate ganglion~     block is performed in supine extended position of the neck. So cricoid cartilage will move~     up to cephalad direction and pain doctors should find C6 or C7 transverse process at lower~     neck area than cricoid cartilage.~   "
111122|NCT01601756|"~     Hypothesis: navigated revision total knee arthroplasty results in a more precise~     reconstruction of preoperatively planned joint line than conventional revision total knee~     arthroplasty (rTKA).~   "
111110|NCT01601912|"~     The primary study aim is to unravel the nature of impaired pain inhibition during exercise~     in patients with chronic Whiplash-Associated Disorders (WAD). This will be ascertained by~     examining whether activation of serotonergic and/or noradrenergic descending pathways~     improves pain inhibition during exercise in these patients. In addition, it is aimed at~     examining whether activation of serotonergic and/or noradrenergic descending pathways~     prevents post-exertional malaise following submaximal exercise in chronic WAD patients. A~     secondary study aim comprises of examining the effect of an acute submaximal exercise with~     and without activation of serotonergic or noradrenergic descending pathways on chronic WAD~     patients' cognitive performance. Furthermore, the isolated effect of activated serotonergic~     and noradrenergic descending pathways on chronic WAD patients' cognitive performance will be~     studied.~   "
111111|NCT01601899|"~     Even with the benefits of HIV therapy, there is a possibility that HIV-infected individuals~     develop metabolic complications once they initiate treatment, which may also ultimately put~     them at a risk for impending heart disease in the next decades.~      The main mechanism through which the main HIV drugs are thought to cause these metabolic~     changes and organ toxicities is mitochondrial toxicity. Most of studies that have been done,~     have taken place in the West, but few, if any, have been done in South Africa.~      The purpose of this study is to prospectively identify early changes between the two~     different drugs, Stavudine and Tenofovir, to assess their virological response, molecular,~     biochemical and clinical picture, and the possible associated change in cardiovascular risk~     factors, this, in the South African setting, and make recommendations to modify the current~     National AIDS role out programme~   "
111112|NCT01601886|"~     This study was designed to analyze whether initiation of the NICHD Neonatal Research Network~     SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery~     room in non-participants and whether these changes were associated with changes in~     management and outcomes.~      The investigators hypothesized that the investigators would observe following the initiation~     of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among~     non-participants preterm infants at Parkland Memorial Hospital.~   "
111113|NCT01601873|"~     The purpose for this study is to evaluate the patency and outcomes of conventional and~     heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.~   "
111114|NCT01601860|"~     Although there are studies that investigated the use of non-pharmacological pain relief and~     correction of dystocia during labor, there are few randomized controlled trials, especially~     related to combined protocols that use such resources. The use of combined protocols could~     potentiate the effects of resource use alone, evidencing the need for more studies related~     to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In~     order to verify the effect of these methods in various stages of labor, childbirth and~     immediately becomes necessary to conduct a randomized controlled trial well-designed and~     adequate sample size that can make the future systematic reviews that can definitely~     conclude about the potential effectiveness of protocols that use combined resources to~     non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a~     protocol of non-pharmacological resources on pain of pregnant women in the active phase of~     cervical dilatation and compared with controls.~   "
111115|NCT01601847|"~     The goal of this study is to identify a vitamin D supplementation strategy that best~     promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks~     gestational age). This is a high risk population that seems to have unique vitamin D needs,~     and inappropriate supplementation may promote wheezing or allergy. The results of this study~     will help form nutritional recommendations for the approximately 100,000 black infants born~     at 30-36 weeks gestational age in the U.S. every year.~   "
111116|NCT01601834|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time~     course of plasma concentration of single oral doses of PF-06273340. The effect of food on~     the Pharmacokinetic of PF-06273340 may also be investigated.~   "
111117|NCT01601821|"~     To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) +~     corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the~     introduction of MMF in de novo renal allograft recipients.~   "
111118|NCT01601808|"~     ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib~     chemotherapy with gemcitabine alone in patients with locally advanced or metastatic~     pancreatic carcinoma.~   "
111119|NCT01601795|"~     The use of volatile anesthetics in cardiac anesthesia is very common, because of their~     cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In~     line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics~     are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile~     anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the~     cardiopulmonary bypass machine (during extracorporeal circulation).~      Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients~     undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the~     cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until~     now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have~     been described.~      Sevoflurane might be of advantage because of additional myocardial protective effects during~     cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane~     during CPB have not been investigated so far, although its being used at many hospitals.~      The investigators will conduct a randomized prospective study with either sevoflurane or~     isoflurane during cardiopulmonary bypass surgery. The study will help to answer the~     questions about the possible cardioprotective effects of the widely used volatile~     anesthetics and the hemodynamic stability during cardiopulmonary bypass. Knowing the~     pharmacokinetics of these drugs allows the anesthesiologist to titrate the volatile~     anesthetics more precise.~      The investigators hypothesizes that the maximal postoperative increase in troponin T will be~     smaller in the sevoflurane group than in the isoflurane group. The investigators~     hypothesizes that the total amount of noradrenaline needed during the entire period of~     cardiopulmonary bypass will be smaller in the sevoflurane group than in the isoflurane~     group. The investigators hypothesizes that kinetics of washin and washout at the CPB will be~     faster in the sevoflurane group than in the isoflurane group. The investigators hypothesizes~     that the time to extubation, respectively the length of stay in intensive care unit and~     hospital is shorter in the sevoflurane group than in the isoflurane group.~   "
111120|NCT01601782|"~     Determine if volume imaging can diagnose bone, ligament, muscle injuries.~   "
111121|NCT01601769|"~     Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis~     and therapy of lesions of the female genital tract as a substitution or a complementary~     method to colposcopy with the development of new standards for a tissue sparing therapy Use~     of existing laparoscopic instruments, which allow a better quality level in the diagnosis~     and therapy than the current routine.~      Development of new optics and instruments, which allow a tissue sparing approach Pre and~     postoperative measurement of the cervical volume, to be sure that the tissue removal is kept~     to a minimum level Development of qualitaty parameters for the most tissue respecting~     operations of the uterine cervix Prospective evaluation of the influence of tissue sparing~     surgery on future pregnancies~   "
111126|NCT01601704|"~     The purpose of this study is to determine the effects of NB relative to placebo on major~     adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial~     infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk~     of having these events because they have diabetes and/or other cardiovascular risk factors.~   "
111127|NCT01601691|"~     The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a~     spacer between prostate and rectum in prostate cancer low dose brachytherapy.~   "
111128|NCT01601678|"~     The aim of this study is to compare short and long-term feasibility, safety and efficacy of~     endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.~   "
111129|NCT01601665|"~     The purpose of this study is to evaluate the use of toric high cylinder power intraocular~     lenses in a larger population in clinical practice and assure the continued safety of these~     approved devices.~   "
111130|NCT01601652|"~     The study will evaluate the safety and efficacy of an intravenous fish oil emulsion~     (omegaven) in infants with parenteral nutrition associated cholestasis.~   "
111131|NCT01601639|"~     The investigators goal is to compare the standard argon plasma coagulation (APC) treatment~     with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.~   "
111132|NCT01601626|"~     There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment~     regimens for HIV-related tuberculosis (TB) among patients who require protease~     inhibitor-based antiretroviral therapy. This study will compare three alternative~     co-treatment options among participants in high TB endemic resource-constrained settings, in~     which one co-treatment option explores if an additional anti-HIV drug needs to be used when~     patients are being treated with a protease inhibitor together with rifabutin-based anti-TB~     treatment.~      Accrual will take place in two accrual periods. Accrual period 1 will enroll 60 participants~     who will undergo an initial dose-finding period before continuing regular study follow-up.~     Once the review of the dose-finding pharmacokinetic and safety data from accrual period 1~     participants is completed, accrual period 2 will begin.~   "
111133|NCT01601613|"~     This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety~     of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with~     Dengue haemorrhagic fever (DHF).~   "
111134|NCT01601600|"~     The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal~     muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly~     adults with sarcopenia and mobility limitations. In addition, this study will generate data~     on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response~     on additional physical function measures in this population. Furthermore, the extended study~     duration will provide information on the stability of BYM-induced changes in skeletal muscle~     and patient function in this subgroup of the older population.~   "
111135|NCT01601587|"~     Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities~     and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway:~     patients are entitled to have influence on their treatment and should receive sufficient~     information directed at empowerment. Nevertheless, studies from Norway have found that~     patients who seek help are dissatisfied with the information they receive and doubt their~     possibility for real influence on their treatment. One way to improve individual PP might be~     to give patients sufficient information and education before they start their treatment in~     the form of an educational group intervention, an introduction seminar (IS); this group~     intervention is less time and resource consuming than individual interventions.~      Aims: The main purpose of this project is to develop and evaluate an IS for patients on a~     waiting list of DPC. The seminar will educate patients, so they can actively participate in~     their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of~     treatment. Another aim is to enable patients to participate in their own treatment, to cope~     with their problems while they are waiting for treatment by providing them contact with~     primary health care and user organizations during their waiting time, and to increase~     adherence.~      Methods: The project involves three components: an exploratory study of educational content~     of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences~     and choices, activation, satisfaction, mental health and cost-benefit) and then a~     post-seminar qualitative evaluation, which will be used to create a broad yet deep~     understanding of the practical side of the participants`experience and the seminar's effect.~   "
111136|NCT01601574|"~     The purpose of this study is to determine whether the Weight Watchers program modified for~     use by people with Type 2 diabetes results in more improvements in blood glucose control~     relative to a control group receiving standard diabetes counseling.~   "
111137|NCT01601561|"~     Background: The hyperinsulinemic-normoglycaemic clamp technique is a precise method of~     providing insulin and glucose while maintaining normoglycemia. High-dose insulin has~     profound effects on glucose and protein metabolism. It has been demonstrated in coronary~     artery bypass graft (CABG) surgery patients that high-dose insulin causes~     hypoaminoacidaemia. The investigators hypothesize that the reduction of plasma amino acids~     (AAs) levels as seen in patients undergoing CABG surgery and receiving high-dose insulin is~     a consequence of an inhibition of whole body proteolysis as assessed by L-[1-13C]leucine~     tracer kinetics.~      Objective: The present study aims to investigate the effect of high-dose insulin therapy on~     whole body protein, glucose and end-organ metabolism in patients undergoing CABG surgery~     using stable isotope tracers [6,6-2H2]glucose, L-[1-13C]-leucine and L-[2H5]phenylalanine.~     The changes in the metabolic-endocrine milieu will also be evaluated by plasma~     concentrations of glucose, lactate, free fatty acids, prealbumin, albumin, fibrinogen,~     insulin, glucagon, and cortisol.~      Methods: With the approval of local institution's ethical committee, 30 patients scheduled~     for elective will be enrolled. The patients will be divided randomly into two groups. The~     control group will receive a standard IV insulin protocol with the aim of keeping blood~     glucose < 10 mmol/L. The treatment group will be administered a high dose insulin infusion~     of 5 mU/kg/min coupled with a variable infusion of glucose to maintain normoglycemia (4-6~     mmol/L). Insulin infusion will be continued until the end of the study period approximately~     8 hours after surgery. L-[1-13C]leucine and [6,6-2H2]glucose kinetics will be used to assess~     changes in whole body protein and glucose kinetics. Hepatic albumin synthesis will be~     determined by using primed continuous infusion of L-[2H5]phenylalanine. The preoperative~     measurements will be performed on the morning before the surgery. Postoperative studies will~     be conducted two hours after arrival in the intensive care unit. Tracer kinetics between the~     two groups will be analyzed using ANOVA for repeated measurements.~      Significance: High-dose-insulin results in a significant reduction in plasma AAs in cardiac~     surgery. This study should address if this drop in plasma AA levels is secondary to a~     decrease in breakdown, an increase in synthesis or both during high-dose insulin therapy in~     open heart surgery.~   "
111286|NCT01599819|"~     The objectives of this study are to assess the tolerability and safety after single dose~     treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to~     determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE,~     and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.~   "
111138|NCT01601548|"~     Upon the completion of aggressive chemotherapy and radiation for curative intent cancers,~     many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such~     as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and~     anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention.~     Mind-body interventions are defined as practices or interventions that focus on the~     connection and integration of the mind and body and the ability for these connections to~     effect changes on physical, emotional and spiritual levels for the purpose of promoting~     health and well being.~   "
111139|NCT01601535|"~     The goal of the first part of this clinical trial (Phase I portion) is to study the side~     effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to~     standard chemotherapy drugs, irinotecan and temozolomide.~      The goal of the second part of this clinical trial (Phase II portion) is to learn how many~     children and young adults show improvements in their neuroblastoma when treated with the~     combination of MLN8237, irinotecan, and temozolomide.~   "
111140|NCT01601522|"~     The purpose of the study is to determine how a type of treatment for peanut allergy known as~     oral desensitization works in the immune system.~   "
111141|NCT01601509|"~     Nasal resistance presents considerable variations during night[8]. Additionally, Oral and~     oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas~     [7].The hypothesis that the present study aims to test is whether the pharmacological~     prevention of increased nasal resistance during night could alter breathing route pattern~     and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal~     resistance.~   "
111142|NCT01601496|"~     The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular~     Graft.~   "
111143|NCT01601483|"~     This is a Phase II/III vehicle controlled, double masked, single center study. A single eye~     of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD)~     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2~     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for~     these patients.~      An analysis of the primary and secondary endpoints will be conducted when all subjects have~     completed 12, 18 and 24 months.~   "
111144|NCT01601470|"~     This study was conducted to investigate the potential for a pharmacokinetic drug-drug~     interaction in support of the co-administration of LCZ696 and sildenafil.~   "
111145|NCT01601457|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of~     activated recombinant human factor VIIgiven in conjunction with standard therapy in patients~     undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular~     fractures.~   "
111146|NCT01601444|"~     Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical~     detection of pleural effusion is often not possible.~      Radiographic examination, widely used for detecting pleural effusion ,is not suitable for~     prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at~     home The currently available methods for monitoring and early detection such as the~     measurement of pulmonary capillary wedge pressure or measurement by double indicator~     thermodilution, are not reliable enough and may themselves lead to complications.~      Measuring internal thoracic impedance (ITI), the main component of which is lung impedance,~     is a noninvasive and safe method. PLE will be diagnosed in accordance with well-accepted~     clinical signs(dyspnea, cyanosis, pulmonary rales, crepitations, arterial hypoxemia) and~     roentgenological criteria~   "
111147|NCT01601431|"~     This is a research study about the usefulness of transparent cap during screening~     colonoscopy. The purpose of the research is to test the usefulness of adding small cap to~     the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy~     will improve the detection of adenomatous polyps (polyps which can become colon cancer later~     on) in comparison to the standard colonoscopy.~   "
111148|NCT01601418|"~     The objective of the study was to assess the effect of a range of single oral doses of YF476~     on pentagastrin-induced gastric acid output in healthy volunteers~   "
111149|NCT01601405|"~     The objectives of the study were:~        1. To show that a single dose of YF476 blocks gastrin receptors in healthy subjects~        2. To show that YF476 retains its ability to block gastrin receptors after repeated dosing~          despite losing its ability to suppress gastric acidity.~   "
111150|NCT01601392|"~     The purpose of this study will to compare the long-term effect of anodal versus cathodal~     transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke~     patients. Forty patients with subacute ischemic stroke will randomly assigned to one of~     three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA~     for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected~     (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke~     Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength~     scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later.~     Motor cortical excitability will be measured at baseline and after the 6th session in both~     hemispheres.~   "
111151|NCT01601379|"~     The purpose of this observational study (this means that no drug is being tested in this~     study) is to obtain updated and detailed information about the Gastroesophageal Reflux~     Disease (GERD) specificities in European patients. The information about patients suffering~     from typical GERD symptoms will be collected in order to establish a classification of adult~     patients profile based on the characteristics of GERD symptoms. This study will only involve~     data collection about the disease. The treatment will not be affected by the study.~   "
111165|NCT01601197|"~     Immunization injections are a significant source of pain for infants. Tactile stimulation~     (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention -~     it is cost neutral, and has been shown to be effective in children and adults undergoing~     injections. The aim of this study is to determine the added benefit of tactile stimulation~     when added to other proven analgesic interventions during routine infant immunization~     injections.~   "
111230|NCT01600352|"~     The purpose of this study is to evaluate the clinical utility of specific autoantibody~     testing in unmasking an underlying connective tissue disorder in patients who present with~     interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt~     connective tissue disease manifestations OR borderline/negative ANA with some clinical~     suggestion of connective tissue disease.~   "
111152|NCT01601366|"~     Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the~     myometrium are associated with surrounding myometrial hypertrophy. The finding classically~     associated with adenomyosis is excessive uterine bleeding accompanied by worsening~     dysmenorrhea. The advent of endovaginal US has substantially improved the ability to~     diagnose adenomyosis. Different US features of adenomyosis have been reported, including~     uterine enlargement not explainable by the presence of leiomyomas, asymmetric thickening of~     the anterior or posterior myometrial wall, lack of contour abnormality or mass effect,~     heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of~     varying sizes, and increased echotexture of the myometrium.~      Transvaginal power Doppler application is useful in studying the vascular tree of~     adenomyosis and can aid clinicians in planning the most appropriate therapeutic strategy.~     The differential diagnosis using power Doppler sonography is based on vascular~     characteristics. Adenomyosis is characterized by a preserved vascular texture supply that~     results in dilated spiral arteries running perpendicular toward the myometrium into the~     endometrial surface. Leiomyomata exhibits a vascular tree that typically circumscribes the~     solid mass. 2D transvaginal power Doppler angiography should be used to improve diagnostic~     sensitivity and facilitate appropriate therapeutic intervention.~      The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe~     for contraception since 1990. Because of the suppressive effect of levonorgestrel on the~     endometrium, Mirena has also been proven to be effective for the management of menorrhagia~     and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was~     introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many~     cases of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for~     the treatment of adenomyosis in Taiwan.~      The current study is designed to evaluate the best treatment modality for treatment of~     adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual~     analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and~     Doppler indices.~   "
111153|NCT01601353|"~     The purpose of this study is to evaluate the safety and efficacy of adipose derived cells~     for the treatment of erectile dysfunction symptoms.~   "
111154|NCT01601340|"~     The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with~     sickle cell disease.~   "
111155|NCT01601327|"~     The aim of the present study was to demonstrate the influences of three different treatment~     strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic~     hypogonadotropic hypogonadism (IHH).~   "
111156|NCT01601314|"~     The purpose of this study is to determine the relationship between magnesium sulphate~     administration and levels of S100B protein in serum of patients undergoing supratentorial~     brain parenchymal resection.~   "
111157|NCT01601301|"~     The purpose of this study is to obtain post market performance and safety data of the~     Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral~     limb lengthening.~   "
111158|NCT01601288|"~     The purpose of this study is to create a prospective database of all patients who have~     undergone pulmonary function testing from which the investigators can study the clinical~     phenotypes of various respiratory conditions. The investigators hope by understanding the~     differences in these myriad phenotypes to be able to provide individualized,~     patient-targeted therapy in the future.~   "
111159|NCT01601275|"~     Prospective data collection of all patients with microbiologically proven mycobacteria~     tuberculosis infection treated at Singapore General Hospital.~   "
111160|NCT01601262|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth~     of new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who~     respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and~     Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were~     Partial Responders to the Initial Treatment.~   "
111161|NCT01601249|"~     Selecting one or two IVF embryos with the highest potential to implant is extremely~     important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal~     gestations. The currently used IVF embryo grading method is based solely on embryo~     morphology (cleavage rate and fragmentation) just before the transfer, which is not very~     well correlated with the implantation potential of each embryo. Oocyte quality and adequacy~     are the most important factors determining the biological quality and implantation potential~     of the embryo. It impossible to grade oocytes using plain optical systems, other than~     maturity and gross anomalies.~      Polscope systems allow to visualize intra ooplasmic structures and determine their~     retardance, as well as that of the Zona Pellucida. The investigators hypothesize that~     grading embryos using the oocyte's parameters as visualized by polscope is superior to~     conventional morphology and correlates better with their implantation potential.~      Here the investigators will perform a prospective randomized controlled trial to examine~     this hypothesis.~   "
111162|NCT01601236|"~     This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety~     of daily Acthar administration in diabetic patients with nephropathy and proteinuria.~     Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be~     enrolled and randomized into 6 study groups and will be treated with either Acthar or~     Placebo for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The~     study will compare three dose regimens of Acthar (8 U [0.1 mL], 16 U [0.2 mL], and 32 U [0.4~     mL]) to equivalent volumes of Placebo to ensure the double-blind nature of the study.~      Insulin-requiring patients are being enrolled to aid compliance with the daily SC~     administration of study medication and to allow for ease of blood glucose control by~     adjustment of current insulin therapy in the event of glycemic excursions. Routine safety~     measures, including glycemic control, will be monitored throughout the study. The adaptive~     design component of the study allows for the re-assignment of the high dose group to the mid~     dose group if unacceptable toxicity is noted as per study protocol in the high dose group.~     Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria~     (via urinary protein to creatinine ratio [PCR]). Serum cortisol concentration and additional~     biomarkers in blood and urine will also be monitored.~   "
111163|NCT01601223|"~     Objectives~        1. To characterize mechanical ventilation practices during general anesthesia for surgery~        2. To assess the dependence of intra-operative and post-operative pulmonary complications~          on intra-operative Mechanical Ventilation (MV) settings~   "
111164|NCT01601210|"~     The purpose of this study is to see if creatine, which is a naturally occurring chemical in~     the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.~      The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate~     for eight weeks will be associated with a significant increase in brain phosphocreatine~     (PCr) concentrations.~   "
111231|NCT01600339|"~     In this phase II multicenter study, the investigators aim to evaluate the efficacy and~     tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for~     metastatic urothelial carcinoma.~   "
111166|NCT01601184|"~     The purpose of this study is to evaluate the safety of vismodegib in combination with~     temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in~     combination with temozolomide in adult patients with recurrent, progressive, or refractory~     medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase~     II).~      This study is an open-label Phase I/II, international, randomized.~      38 patients will be included in the study.~   "
111167|NCT01601171|"~     The purpose of this study is to explore the genetic basis of reproductive disorders.~   "
111168|NCT01601158|"~     This open-label study aims to evaluate the safety and efficacy of umbilical cord blood~     therapy for children with global developmental delay.~   "
111169|NCT01601145|"~     The aim of the present research protocol was to evaluate the effect of probiotics daily~     used, on the plaque acidogenicity of children. The null hypothesis was that the plaque~     acidogenicity would remain unchanged and not associate with the use of probiotics. Moreover,~     the in situ study will be carried out to investigate the plaque formation as biofilm in~     demineralised enamel specimens following the regular consumption of a probiotic product~     compared to a control group. Metabolic of the biofilm formed on of the enamel specimens~     resulting from the consumption will be evaluated over a period of 8 weeks.~   "
111170|NCT01601132|"~     Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe~     substrate. When the two are co-administered the potential exists for a clinically~     significant drug interaction. This study aims to determine the effect of steady-state~     colchicine on the pharmacokinetics of theophylline administered as a single dose. A~     secondary goal is to evaluate the safety and tolerability of this regimen in healthy~     volunteers. All study subjects will be monitored for adverse events throughout the entire~     study period.~   "
111171|NCT01601119|"~     The objective is to establish the impact of current disease modifying therapies (DMTs) and~     associated support services on Patient Reported Experience Measures and Patient Reported~     Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the~     United Kingdom (UK).~   "
111172|NCT01601106|"~     Cardiovascular disease(CVD) is the leading cause of morbidity and mortality in developed~     nations. CVD is primarily caused by atherosclerosis, a systemic disease characterized by~     lipid deposition in the subendothelial space with a concomitant, low-grade inflammatory~     reaction.(Fuster, Moreno et al. 2005) To date, most therapeutic interventions aimed at~     lowering CVD have thus far focused on modulating lipid levels, either lowering LDLc or~     increasing HDLc levels. Yet, since the introduction of statins 20 years ago, there have been~     few breakthroughs in the treatment of this disease. A promising strategy to reduce CVD is to~     directly target inflammation at the level of the vessel wall.(van Leuven, van Wijk et al.;~     Libby 2002) A potential drawback of anti-inflammatory strategies pertains to the thin line~     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression.~     Therefore, continuous low dosed anti-inflammatory drugs have great potential as novel~     treatment strategies. In the present project, the investigators propose to inject liposomal~     glucocorticoids intravenously in patients with an increased risk of atherosclerotic disease~     aiming to reduce vessel wall inflammation.~   "
111173|NCT01601093|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory~     and urinary tract acute bacterial infection.~   "
111174|NCT01601080|"~     This is an observational, retrospective, UK & Ireland audit measuring patient adherence to~     Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple~     Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™~     device for injection for a minimum of 24 months.~   "
111175|NCT01601067|"~     Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common.~     Currently available treatments often do not lead to sustained recovery from these disorders,~     possibly because they typically do not include exposure therapy which is considered best~     practice treatments for PTSD. This study compares exposure-based integrated treatment to~     integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and~     PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain~     PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change~     common treatment practices for comorbid AD and PTSD by increasing the availability of~     evidence-based PTSD treatment for those with AD.~   "
111176|NCT01601054|"~     Within the last decade there has been an increase in the number of surgical procedures for~     deformities of the spine. This is caused by the increase in the elderly population, improved~     surgical techniques and an increased number of patients who have undergone previous surgical~     treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities~     bears a revision rate between 15 and 30% depending on definition, and one of the primary~     reasons for revision surgery is implant loosening in the lumbosacral region.~      The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar~     spine in addition to the usual posterior instrumentation can reduce the revision rate with~     50%.~   "
111177|NCT01601041|"~     The purpose of this prospective study is to investigate the association between the amount~     of residual urine and asymptomatic bacterial prostate infection with the occurrence of~     recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic~     (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction~     performing intermittent catheterization.~      The following hypotheses will be tested:~        1. The amount of residual urine after intermittent catheterization is significantly~          greater in SCI patients suffering from frequent (>2 /year) urinary tract infections~          compared to those without.~        2. The incidence of asymptomatic bacterial prostate infections is significantly higher in~          SCI patients suffering from frequent (>2 /year) urinary tract infections compared to~          those without.~   "
111207|NCT01600651|"~     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar~     epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the~     pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the~     influence of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The~     purpose of this prospective monocentric randomized controlled cross-over study is to~     describe the effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse~     ARDS.~   "
111178|NCT01601028|"~     Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with~     dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome~     patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren~     syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies~     have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no~     randomized controlled study has been done. So the investigators evaluate the effectiveness~     and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled~     study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N =~     30).~   "
111179|NCT01601015|"~     Background. Tension-type headache (TTH) is the most common form of primary headache and it~     is a real problem for the subjects suffering from it. Until now, physiotherapy treatments~     have included different techniques combined together, without establishing which of them is~     more effective.~      Objective. The purpose of this study is to know the effectiveness of manipulative and manual~     therapy treatments, with regard to pain perception and neck mobility in patients with~     tension-type headache.~      Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed~     with tension-type headache, divided into three treatment groups -manual therapy,~     manipulative therapy, and a combination of both techniques-, and a placebo control group.~     Four treatment sessions were administered during four weeks, with post-treatment assessment,~     and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well~     as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches~     (weekly register).~   "
111180|NCT01601002|"~     Patients with an episode of depression in late life prescribed mirtazapine recruited from a~     clinical sample will be monitored for weight and receive a blood test during their usual~     course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect~     weight gain.~   "
111181|NCT01600989|"~     Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria~     and that the resulting mitochondrial dysfunction is related to the severity and outcome of~     the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and~     ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal~     and heart muscle tissue and blood cells. Circulating immune cells play an important role in~     the pathophysiology of sepsis. Stimulation of the immune system alters the energy~     requirements of immune cells; down-regulation of immune-cell activity has been associated~     with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively~     investigate changes in mitochondrial function of immune cells in patients with severe sepsis~     and septic shock. The following main hypotheses will be evaluated:~        -  Severe sepsis and septic shock leads to increased energy requirements of immune cells~          and to an increase in mitochondrial enzyme activities and energy production.~        -  Changes of mitochondrial function in human immune cells are associated with alterations~          in clinical and laboratory markers of severity of sepsis.~        -  Prolonged sepsis and unfavourable outcome is associated with down regulation of~          mitochondrial function.~      Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to~     severe sepsis or septic shock will be included in the study; 30 healthy volunteers serve as~     controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases,~     after transplantations or receiving immunosuppressive agents are excluded.~      Collected baseline characteristics include patient demographics, diagnosis and severity of~     illness scores at the time of admission. Daily collected follow up data include clinical and~     laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of~     antibiotics, use of steroids and results of microbiological cultures/stains.~      Negative identification and isolation of monocytes, B cells and CD4 T cells will be~     performed daily from ICU admission to discharge using an antibody-antigen mediated~     immunomagnetic cell isolation procedure that depletes all blood cells except the specific~     target cells. Mitochondrial function of immune cells will be assessed by measurement of~     mitochondrial complex activity for complexes I to IV by a standard titration protocol.~     Additionally, the levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6,~     IL-10, TNF-α) will be assessed throughout the stay in the ICU. For comparison mitochondrial~     function of of monocytes, B cells and CD4 T cells and cytokine levels will be measured in a~     group of 10 healthy volunteers.~      Analysis plan: Changes in mitochondrial function of immune cells over time compared to a~     healthy control group and during the course of severe sepsis and septic shock is the main~     outcome parameter of this study. Assessed predictors are determined by the severity of the~     underlying septic condition and include clinical and laboratory evidence for dysfunction of~     vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.~   "
111182|NCT01600976|"~     The purpose of this study is to determine whether the pharmacokinetic (what the body does to~     the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment,~     compared to the pharmacokinetic parameters in patients with normal liver function, and~     measure the relative unbound plasma concentrations of telaprevir.~   "
111183|NCT01600963|"~     The purpose of this study is to provide safety and efficacy data for TMC207 and to~     demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the~     BR plus placebo.~   "
111184|NCT01600950|"~     The study involves a single injection of LY2963016 and a single injection of Lantus, on 2~     separate occasions in participants with type I diabetes. Following each dose, participants~     will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7~     days between the two periods, during which time there will be no study treatment, but~     participants will resume their regular therapy. The duration of this study can be up to 9.5~     weeks. The purposes of this study are to understand how the blood sugar lowering effect of~     LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are~     metabolized by participants with type I diabetes.~   "
111185|NCT01600937|"~     Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to~     ensure optimal benefits to control blood glucose, lipids, blood pressure, and other~     cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put~     into action for a number of barriers and poor long-term patient compliance. This project~     will assess the effect of a behavioral intervention strategy on the promotion and~     maintenance of physical activity in type 2 diabetes.~   "
111186|NCT01600924|"~     This project will assess the independent predictors of impaired muscle and bone strength~     through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes~     consecutively attending an outpatients diabetes clinics for the annual screening of~     complications.~   "
111187|NCT01600911|"~     Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients~     and non-nutrients still remains to be discovered.We design a feeding study which provides~     plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The~     goal of this study is to establish a protocol for documenting metabolomics response to plant~     foods and try to characterize plant foods in terms of their anti-hypertension potentials~     with metabolomic profiling information.~   "
111208|NCT01600638|"~     The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and~     the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population~     with sharp body curvature.~   "
111232|NCT01600326|"~     The purpose of this study is to determine the effectiveness of various treatment soft~     tendinosis also known as tendinitis.~   "
111233|NCT01600313|"~     The purpose of this study is to determine the effect of rice bran oil with low calorie diet~     on lipid profiles.~   "
111188|NCT01600898|"~     In this prospective study, the investigators will implement a systematic screening program~     and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is~     designed to:~        -  determine predictive factors (biological, functional, radiological and hemodynamic) of~          development of PAH~        -  monitor these subjects' clinical, functional, biological, echocardiographic and~          hemodynamic characteristics~        -  assess the risk of occurrence of PAH~        -  screen patients with PAH at an early stage of disease and offer them an early~          management~        -  constitute a collection of biological samples (0, 12, 24 months follow-up) of~          asymptomatic BMPR2 mutation carriers.~   "
111189|NCT01600885|"~     The purpose of the study is~        1. To establish the feasibility of fMRI studies of the interaction of guanfacine and~          ketamine.~        2. To explore the possibility that guanfacine can ameliorate the negative effects of~          ketamine on task-related prefrontal activation.~        3. To assess the strength of any interaction between guanfacine and ketamine.~   "
111190|NCT01600872|"~     Both oxidative stress and Bisphenol A (BPA) had been associated with polycystic ovary~     syndrome (PCOS). BPA, one of endocrine-disrupting chemicals (EDCs), is an environmental~     estrogen used in the synthesis of plastics, is a high-volume production chemical with~     widespread human exposure. BPA was been reported in several female reproductive disturbance.~     However, the pathological pathway of BPA impact on female reproductive system had not been~     well-understood. Reactive oxygen species (ROS) have a role in the modulation of gamete~     quality and gamete interaction. Persistent and elevated generation of ROS leads to a~     disturbance of redox potential that in turn causes oxidative stress (OS). The first part of~     The investigators study is aim to evaluate the oxidative stress impact on the biochemical~     parameters in women with PCOS; the secondary part of the investigators study is to~     investigate the BPA on the clinical and biochemical of women with PCOS; finally, the~     investigators plan to test the hypothesis that BPA might increase oxidative stress and then~     elevated ROS in women with menstrual disturbance, furthermore, the role of oxidative stress~     and BPA impact on insulin resistance and metabolic disturbance will be also investigated.~      Study and control cases will be included. Serum total oxidant status (TOS), total~     antioxidant status (TAS), Bisphenol A (BPA), and clinical/biochemical parameters will be~     obtained for all cases. Oxidative stress and BPA will be evaluated with all~     clinical/biochemical parameters for all subjects.~   "
111191|NCT01600859|"~     Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild~     cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking~     thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor~     (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to~     Screening and remain on their stable dose throughout the trial. Subjects will receive~     placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally,~     the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid~     biomarkers and cognitive and psychological measures.~   "
111192|NCT01600846|"~     The purpose of this study is to further integrate pharmacogenetic (PGx) testing into~     clinical practice by educating physicians about pharmacogenetics and offering testing to~     their patients. Pharmacogenetic testing may help physicians choose the best drug and dosage~     for their patients which can reduce side effects, increase effectiveness, and improve~     patient adherence.~      Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to~     physicians and to advise what patients may benefit from PGx testing; the other clinic will~     have a pharmacist on call.~      Patient and physician perspectives about PGx testing and their utilization will be examined~     via surveys.~      The investigators hypothesize that with education about PGx testing, more physicians will~     utilize testing.~   "
111193|NCT01600833|"~     The purpose of this study is to study the association of serum ferritin and homocysteine~     levels with insulin resistance and metabolic syndrome in women with polycystic ovary~     syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10%~     of women with reproductive age. Insulin resistance and metabolic disturbance are well-known~     long-term consequence of women with PCOS. Recent evidence suggests that increased body iron~     might be involved in the pathogenesis of insulin-resistance disorders, furthermore,~     hyperhomocysteinemia is associated with an increased risk of atherosclerotic and~     thromboembolic disorder. The investigators plan to retrospectively review the medical~     records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang~     Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.~   "
111194|NCT01600820|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly~     hypercholesterolemic subjects treated or not by statins.~   "
111195|NCT01600807|"~     OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been~     used in other research studies and information from those suggests that OSI-906 may help~     block cell receptors involved in tumor growth.~      Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this~     research study, the investigators are looking for the highest dose of OSI-906 that can be~     given safely in combination with gemcitabine and erlotinib. This dose will then be given~     together with gemcitabine and erlotinib to a further group of patients with pancreatic~     cancer.~   "
111227|NCT01600391|"~     Given that visual information comprises one of the most important and salient sources of~     information used during walking, that visual cues have been shown to be more effective than~     auditory cues in triggering gait adjustments and that stroke survivors have been reported to~     become more dependent on visual cues, the investigators hypothesize that visual cues would~     be more effective in triggering gait recovery and adaptability following stroke than~     interventions not including visual cues.~      The investigators will integrate visual cues with walking and turning practice, and contrast~     this intervention to routine overground walking practice. Stroke participants recruited from~     NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three~     gait rehabilitation groups. Each group will receive the same frequency and duration of~     treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and~     usual care (UC) groups will be treated in participating NHS sites. Treadmill training with~     visual cues (TVCT) will take place at the University of Birmingham.~   "
111196|NCT01600794|"~     Because the society convention is changed, people are late for getting married, leading to~     increasing the bearing age in women. According to the previous study, if the age is over 30,~     the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is~     collected by Bureau of Health Promotion, Department of Health shows that there are about~     7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in~     every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is~     important to know how to estimate and approve the ovary function that lead to increase the~     live birth rate. The investigators plan to estimate the correlation between the serum~     androgens levels and pregnancy outcome in the women who have infertility problem.~     Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of~     the possible effect from stimulated drugs used on previous cycle. It's important to~     understand the ovary function for IVF patient to choose the appropriate drugs and dose.~      The investigators use blood and clinical test to analyze, the items for analysis are below:~        1. Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、~        2. Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S~        3. Clinical test: Ultrasound~        4. Personal condition. In order to finishing the test, every patient will be asked to~          collect about 10 to 15 cc blood for the research.~   "
111197|NCT01600781|"~     This is a randomised, controlled, open-label intervention study. It is hypothesized that~     supplementation with a fibre enriched sip feed will improve the nutritional status, gut~     microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may~     enhance their immune response. This could give them a better chance to finish their~     induction chemotherapy successfully with fewer side effects.~   "
111198|NCT01600768|"~     The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of~     extended infusion of beta-lactams in intensive care patients who are infected with~     Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).~   "
111199|NCT01600755|"~     The aim of this clinical study is to investigate the safety and feasibility of Autologous~     Muscle Derived Cells (AMDC; a preparation of a patient's own cells) injection into the anal~     sphincter for treatment of patients with fecal incontinence.~   "
111200|NCT01600742|"~     Vorinostat is a potent and well tolerated HDAC inhibitor. It has been reported to enhance~     radiosensitivity of cancer cells. We hypothesize that the addition of vorinostat to WBRT may~     increase therapeutic efficacy for patients with brain metastases.~   "
111201|NCT01600729|"~     This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle~     Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.~   "
111202|NCT01600716|"~     This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the~     treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.~   "
111203|NCT01600703|"~     Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon~     like peptide 1) reduces intestinal production of lipoprotein particles. The investigators~     therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will~     reduce intestinal lipoprotein production in humans. The investigators are unable to~     speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of~     of data from animal studies or in vitro data. Sitagliptin is already an approved treatment~     for type 2 diabetes.~   "
111204|NCT01600690|"~     Statins are commonly prescribed to lower cardiovascular risk in primary and secondary~     prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a~     short term statin withdrawal can have dramatic consequences on atherosclerotic plaque~     stability, owing to a rebound in cholesterol levels and inflammation.~      The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and~     monocyte/macrophage polarization is unknown.~      In this study, the investigators will explore the effects of a 5-day statin withdrawal on~     EPC and monocyte/macrophage polarization, together with other inflammatory biomarkers in~     type 2 diabetic patients. The investigators hypothesize that statin withdrawal determines a~     reduction in EPC levels and an inflammatory cell polarization.~      Patients will be randomized to continue their habitual statin regimen or to withdraw statin.~     At baseline and 5 days later, blood samples will be collected for experimental measures.~   "
111205|NCT01600677|"~     The research study is a randomized controlled trial (RCT). The primary endpoint is to~     compare medication adherence of adult patients recently hospitalized with a diagnosis of~     common cardiac conditions who require medication assistance either by receiving usual care~     or by using a medication delivery unit. The overall study will last a total of 12 months.~     Each subject will be enrolled for a period of 90 days.~   "
111206|NCT01600664|"~     A randomized controlled study to evaluate the effect of 3 months use with interactive~     computer game- My Diabetic Friend- comparing to conventional diabetes education on~     metabolic control, quality of life and diabetes knowledge.Patients will be randomized into~     two groups- one group will be supplied with interactive computer game, My Diabetic friend,~     installed on a computer designed for children's educational needs for a period of three~     months and the other group will be supplied with the same computer without the interactive~     computer game for three months. Metabolic control, quality of life and diabetes knowledge~     will be evaluated before and after the use of the computer.~      The trial is consisting of two main periods: 3 months of the main study period and an~     optional extension period consisting of the following 3 months :~      The study will include two main periods;~        1. Period 1 which will last 3 months, in a randomized controlled manner, this period will~          serve as the main study period to assess the primary and secondary endpoints of the~          study.~        2. Period 2: this extension period will not be an integral part of the study, and only~          patients who are willing will take part at this period, will continue to participate at~          the optional extension period. During the extension period, patients in the~          intervention group will be offered to continue the use of the Computer game -My~          diabetic friend) for the following 3 months, and patients who participated at the~          control group during period 1, will be offered to start to use the Computer Game - My~          Diabetic Friend for the following 3 months.~   "
111234|NCT01600300|"~     Hypothesis: external electrical stimulation of the retina with low level electrical currents~     improves visual acuity in subjects with age-related dry macular degeneration.~   "
111209|NCT01600625|"~     One of the important factors in obtaining successful outcomes when treating severe meibomian~     gland dysfunction (MGD) is to control the existing ocular and eyelid inflammation. Thus, in~     previous studies, topical and systemic antibiotics with anti-inflammatory function, such as~     topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to~     treat severe MGD. In this study, minocycline which had the fewest side effects was used to~     evaluate the effect on cytokine levels in severe MGD. At study initiation, all patients~     completed an Ocular Surface Disease Index (OSDI) questionnaire and had an ocular surface,~     tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time~     (TBUT), Schirmer test, corneal and conjunctival fluorescein staining, microscopic~     examination of lid margins and meibomian glands, and tear cytokine levels. All measurements~     except tear cytokine levels were conducted in the same manner before treatment, after 1~     month, and after 2 months of treatment. Tear cytokine levels were evaluated before treatment~     and after 2 months of treatment. The aim of this research was to determine the concentration~     of inflammatory cytokines in the tears of patients with MGD and to compare the cytokine~     levels, corresponding clinical responses, and ocular symptoms before and after 2 months of~     treatment with oral minocycline.~   "
111210|NCT01600612|"~     Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an~     estimated mortality of 140 000 per year. Uterine atony is one of the most important causes~     of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the~     most conventional drug which was proved effective. However, it has the shortcomings of short~     half life and the necessity of intravenous administration. Misopristol, and more recently~     Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.~      Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin~     for treatment of atonic PPH.~   "
111211|NCT01600599|"~     The purpose of this study is to assess the efficacy of IV Tranexamic Acid and topical~     Tranexamic Acid to control post op bleeding following Coronary Artery Bypass Graft Surgery~     using Cardiopulmonary Bypass.~   "
111212|NCT01600586|"~     NICU infants are at high risk for oromotor difficulties including poor coordination of~     sucking swallowing and breathing. These feeding difficulties often result in prolonged~     hospitalization, with increased physiologic stressors and poor growth. In preliminary~     studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and~     decreased length of hospitalization.~      The investigators propose to test the hypothesis that a week-long PAL intervention can~     improve feeding skills and decrease stress compared to standard of care parental~     interactions in infants in the late preterm period. The investigators also hypothesize that~     these improvements will result in shorter hospital stays and increased growth in the~     intervention group.~      Our study design is a prospective randomized controlled trial design of 94 NICU infants~     (Post-conceptional ages 34-36 weeks) in the Vanderbilt NICU. The 47 intervention-group~     infant/mother dads will receive a book library with one lullaby book and record her voice to~     the PAL, which the music therapist will then administer in 15-minute sessions for 5~     consecutive days. The 47 participants in the control group will receive the same library but~     no recording will be made or PAL used. Outcomes measured will include time to full oral~     feeds, suck rate and efficiency, salivary cortisol levels before and after intervention,~     daily growth parameters and nutritional data, and hospital length of stay.~   "
111213|NCT01600573|"~     This clinical trial shall clarify the efficacy and safety of pazopanib in combination with~     weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive~     recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma~   "
111214|NCT01600560|"~     With the surge in use of electronic media among adolescents, a strategy that has been~     utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents.~     To date, no published study has looked at the effectiveness of texting adolescents~     themselves (especially boys) rather than their parents OR compared texting to social network~     sites to increase HPV knowledge and uptake of HPV vaccination in boys. Interactive~     technology-based interventions targeted at youth are feasible in North Carolina for the~     following reasons: (1) through the NC Minors' Consent Law adolescents can consent to the~     prevention, diagnosis, and treatment of sexually transmitted diseases (N.C. Gen. Stat. §~     90-21.5(a); and (2) many school based health centers can provide immunizations. Since HPV~     infection is a sexually transmitted infection, NC teens do not have to get consent for HPV~     prevention (i.e., vaccination).~      To optimize HPV vaccination in young people, especially males, communication strategies are~     needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated~     to be a feasible, popular, and effective method of sexual health promotion to young people~     with a relatively low withdrawal rate, positive feedback, and an observed improvement in~     sexual health knowledge and STI testing (12). Social media communication strategies are a~     new and potentially effective channel for communicating public health messages about HPV~     vaccine that are also likely to increase HPV initiation and completion among adolescent~     girls in addition to boys.~      According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13~     had received at least one dose of HPV vaccine. In the investigators continuity clinic less~     than 50 percent of adolescents are fully immunized. This project will identify social~     behavioral, emotional, and cognitive correlates and predictors that help explain why teens~     pursue, complete, and do not complete HPV vaccination, and develop a social media~     communication intervention collaboratively with teens to increase HPV vaccine initiation and~     completion.~   "
111215|NCT01600547|"~     Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and~     fall increases the risk of fracture. Falls in the elderly are associated with a high~     morbidity and mortality with potentially life-threatening consequences of falls including~     fractures. Besides fracture fall may cause long term problems such as disability fear of~     falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip~     and spine. The investigators want to investigate whether other more accessible and less~     expensive testing methods can be used to diagnose osteoporosis. Additionally, the~     investigators will examine the incidence of osteoporosis among the elderly in the~     municipality of Odense. Finally, the investigators would like to investigate the association~     between factors that can lead to falls and to investigate the performance of older and~     whether there are changes in functional ability over time.~   "
111216|NCT01600534|"~     This study includes a behavioral educational intervention that focuses on healthy eating and~     physical activity during pregnancy and the postpartum among women newly diagnosed with~     gestational diabetes mellitus (GDM).~   "
111217|NCT01600521|"~     The purpose of this study is to evaluate the efficacy and safety of a combined therapy for~     rheumatoid arthritis (RA). The combined therapy contained paeoniflorin (Brand name:~     Pafulin), which has anti-inflammation properties, and Cervus and Cucumis polypeptide~     injection (Brand name: Songmeile), which has bone healing, pain relieving, and~     anti-inflammation properties. The hypothesis is that this remedy, which has long been used~     by the world's largest RA community, is effective and safe when tested by modern clinical~     standards and criteria.~   "
111218|NCT01600508|"~     Background:~      Videoconference (VC) is a common clinical tool and has huge potential to alter medical~     practice and to offer patients the best expertise in treatment and follow-up in spite of~     long distances, especially in rural areas. Studies upon selected patient groups have shown~     that VC is safe and cost-effective. However, RCT of VC patients with stoma problems have~     never been performed.~      Patients with stoma problems are resource demanding patients. The University Hospital North~     Norway (UNN) has several hundred consultations for this patient group each year, serving the~     population in North Norway.~      Methods: In this randomised controlled trial (RCT), patients are either randomised to a VC~     consultation or a regular consultation at the outpatient clinic. All patients with a stoma~     that needs special attention are eligible for inclusion. Patients randomised to the VC~     group, are set-up to a meeting at the nearest VC studio located to their home community.~     There will be educated VC- stoma nurses that will participate in the clinical examination at~     the hospital outpatient clinic and at the rural VC studio.~      Endpoints: Primary endpoints are patient satisfaction and quality of life. Secondary~     endpoints are number of consultations and cost effectiveness.~      Sample size calculations showed that 170 patients had to be included in the trial.~      The investigators hypothesize that postoperative follow-up of stoma patients by VC will not~     have any impact on patients' quality of life compared to Hospital outpatient follow-up.~     Furthermore, the investigators hypothesize that the incremental cost-effectiveness ratio~     will improve.~   "
111219|NCT01600495|"~     The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical~     Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research~     will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant~     women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be~     divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and~     will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm~     of cervical dilation. The evaluation will be performed by numerical category scale, location~     and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a~     questionnaire of customer satisfaction.~   "
111220|NCT01600482|"~     The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and~     effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery~     access site in patients on anticoagulation who are undergoing a percutaneous coronary~     intervention (PCI) procedure using either a 6F or 7F procedural sheath.~   "
111221|NCT01600469|"~     NMDA activation plays an important role in learning and memory. NMDA receptors were found to~     decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive~     function impairment. This study is a randomized, double-blind, placebo-controlled drug~     trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group~     (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The~     investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive~     function in patients with mild cognitive impairment or mild Alzheimer's disease.~   "
111222|NCT01600456|"~     The specific aims of this study are:~        1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE)~          to that of PE and medication (sertraline).~        2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9~          months post-treatment.~        3. To compare those who have chosen their treatment to those who have not in terms of~          completion of treatment, treatment satisfaction, and short- and long-term effectiveness~          of the treatment.~        4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.~   "
111223|NCT01600443|"~     The study is undertaken to investigate if the urethral microtrauma, caused by intermittent~     catheterization, differs between three hydrophilic catheters for intermittent~     catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a~     prospective, randomised, cross-over, single-centre study.~      Each subject will be randomized to use three different catheter types. Three~     catheterizations will be performed with each catheter type during one day, with at least two~     hours between each catheterization. The washout period between catheter switch will be at~     least one week.~      The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters~     with regards to hematuria after intermittent catheterization.~      The secondary objectives are to evaluate urethral microtrauma for three hydrophilic~     catheters with regards to pyuria and subjective evaluation after intermittent~     catheterization.~      The safety of the three catheters will be evaluated in terms of adverse advents, non-serious~     and serious, rated for causality.~      The hypothesis that level of hematuria is equal after using different catheters will be~     tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is~     less than 5%.~   "
111224|NCT01600430|"~     The study hypothesis states that giving early enteral Vitamin D supplementation to preterm~     infants will decrease respiratory morbidity in extremely preterm infants.~   "
111225|NCT01600417|"~     The aim of the study is to evaluate the feasibility and validity of conventional radiographs~     of the lumbo-sacral spine when the patient is lying on a special table which facilitates~     maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on~     the table will be compared with those gained from standard flexion-extension radiographs of~     the lumbo-sacral spine.~   "
111226|NCT01600404|"~     Prospective evaluation of the cognitive function of in-house patients suffering from an~     acute traumatic spinal cord injury before and three months after the initiation of~     antimuscarinic treatment.~      The following hypothesis will be tested: Antimuscarinic treatment results in significantly~     worse cognitive test results three months after traumatic spinal cord injury compared to the~     pre-treatment results and the results of the control group.~   "
111228|NCT01600378|"~     The purpose of this study is to generate a prospective database of all patients evaluated~     for diffuse parenchymal lung diseases to provide much needed data on the various disease~     aetiologies, incidence and prevalence rates, clinical and radiological presentations,~     pathologic correlations, disease progression and response to treatment, and final outcomes~     in this group of patients in Singapore.~   "
111229|NCT01600365|"~     The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of~     conjunctivitis caused by adenovirus.~   "
111287|NCT01599806|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to~     Doripenem for treating hospitalized patients with complicated urinary tract infections,~     including acute pyelonephritis~   "
111236|NCT01600274|"~     -  Characterisation of relative bioavailability of Diena (Test) in comparison to Valette®~          (Reference) after single dose administration under fasting conditions~        -  Assessment of bioequivalence of Test vs. Reference after single dose administration~          under fasting conditions, determined by use of area under the concentration time curve~          AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and~          dienogest (DNG)~        -  Descriptive characterisation of safety and tolerability of the investigational products~          in the study population~   "
111237|NCT01600261|"~     Comparison study to assess photo image quality of a new color fundus camera compared to that~     of a commercially available color fundus camera.~   "
111238|NCT01600248|"~     This study will evaluate the usefulness of an online, self-directed treatment for chronic~     pain that has been designed specifically for individuals who are currently or have~     previously served in the military.~   "
111239|NCT01600235|"~     The purpose of this study is to evaluate the safety and efficacy of the induced hypertension~     using phenylephrine in patients with noncardioembolic ischemic stroke.~      The investigators hypothesized that phenylephrine induced-hypertension can result in good~     clinical response without serious complications in patients with noncardioembolic ischemic~     stroke.~   "
111240|NCT01600222|"~     A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of~     LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.~   "
111241|NCT01600209|"~     The objective of this study is to confirm the sensitivity and specificity of a stool DNA~     test for detection of colorectal cancer and pre-cancer.~   "
111242|NCT01600196|"~     The purpose of this study is to evaluate the long-term efficacy and safety of surgical~     resection compared with best supportive care in patients with resectable hepatocellular~     carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.~   "
111243|NCT01600183|"~     This is a prospective, randomized, control, open label study in which up to 50 subjects with~     metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard~     casting or using the UNFO-s device for total time of 20 weeks.~   "
111244|NCT01600170|"~     HIV associated neurological disorders (HAND), are a major problem even in ART treated~     people. HAND results from chronic inflammation which is largely attributed to expansion and~     activation of monocytes. These activated monocytes, some of which also carry virus to the~     brain, invade the CNS and release cytokines / chemokines resulting in further recruitment of~     monocytes, as well as release viral proteins which injure neurons and cause activation of~     other brain cells. Persistent monocyte/macrophage activation is thus a potential critical~     target for adjunctive therapy to treat or prevent HAND. The investigators therefore propose~     to study the effects of a statin drug (Atorvastatin), which has anti-inflammatory functions,~     on the monocyte activation status in vitro and in ART treated HIV+ individuals.~      The investigators objectives are based on the hypothesis that Atorvastatin treatment will~     reduce the inflammatory and activated phenotype and function of monocytes which have been~     linked to HIV associated neuropathogenesis and occur in HIV infected subjects despite ART.~     In this study the investigators propose to~        1. determine how Atorvastatin modulates monocyte activation, intracellular signaling~          pathways and functions implicated in the pathogenesis of HAND in vitro~        2. define the effect of Atorvastatin on monocyte activation in HIV infected / ART treated~          subjects in a double blind, placebo controlled crossover study~        3. define gene expression patters of monocyte activation before and following statin~          treatment~        4. assess Atorvastatin effects on CNS immune activation markers and neurocognitive~          function in ART treated subjects.~   "
111245|NCT01600157|"~     Background Fast-track concepts reduced hospital stay from 15-20 days to three days for~     patients who underwent a colon resection [1-5]. A well-designed pilot study determined the~     efficacy of a fast-track program for a laparoscopic radical nephrectomy, and the fast-track~     group was discharged earlier from the recovery room median (74+/-23 v 103+/-47 minutes) as~     well as from the hospital median (41+/-11 v 59+/-11 hours) [6]. Implementation of the~     principles of the fast-track program shortened the postoperative hospital stay from eight to~     four days for patients who underwent an open radical nephrectomy [7]. Taek-Gu Lee et al.~     documented how early mobilization after colon surgery resulted in reduced recovery times~     without increased complications [8]. Laparoscopic surgery is minimal invasive with less~     surgical stress, morbidity and mortality [9]. The use of laparoscopic nephrectomy in Denmark~     reduces the hospital stay to 5.2 days which did not meet the foreign countries outcome [06].~      Therefore a combination of the advantages of laparoscopic surgery and the fast-track~     concepts could be used by nephrectomies. However, no prospective studies describing the~     course after nephrectomies, where these advantages are exploited and it is important to make~     a basic study to describe and understand the factors of surgical outcome.~      Aim of study To describe the postoperative period after laparoscopic trans-peritoneal~     nephrectomy that performed as an ambulatory procedure.~      Method A prospective study will involve 62 patients who have been diagnosed with Cancer~     Renis DC649.~      All patients will receive the results of CT-scanning at outpatient and of them who meet the~     inclusion criteria for the study will be informed about the study and will receive a written~     information according to appendix 1., and a new time with (NA) to get the results for kidney~     function and oral information about the study as well as their acceptation to be connected~     to the study, those patients will receive a standard recommendation to be discharged from~     hospital on the day of their operation and they will restart their normal activities the day~     after the operation unless there are preventing factors. All patients will be thoroughly~     informed by the examiner how to complete the questionnaire and will come through different~     tests according to appendix 2., a blood test will be taken according to appendix 12.~      All patients should have a CT-scanning of abdomen, chest X-ray and kidney function test~     before the operations.~      Statistic The number of patients, have been decided to be included to each study, is based~     on the realized number of nephrectomy operations that can be done during the specified~     period within each department and not on the statistic power of study.~      The Scheffé's test will be used for multiple comparisons. The correlation between variables~     will be evaluated by using the Spearman's rank correlation coefficient. P values less than~     0.05 is considered significant. Statistical analyses will be performed by SPSS statistic~     program software.~      Publications The results of each study, irrespective of whether these are positive or~     negative, will be published in international scientific journals and will be distributed at~     relative conferences. The published articles will have Azawi NH as first author, Christensen~     T as last author and co-authors according to Vancouver rules.~      Ethics The study will be reported to the Danish National Committee on Biomedical Research~     Ethics and regionsjaelland paraplygodtkendelsen data control, Ph.D. student (NA) will apply~     for enrollment to the PhD programme at the University of Copenhagen. Consent forms will be~     received from all patients and they will receive written information about project. The~     project will protect all of the data gathered.~   "
111246|NCT01599169|"~     The purpose of this study is to determine the efficacy and the tolerance of the food~     supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and~     Extramel®, on the burnout syndrome.~   "
111247|NCT01599156|"~     The purpose of this study is to examine if the use of reflexology can alleviate chronic~     constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks~     of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18~     years of age or older, which are able to comply with the study guidelines; Fewer than three~     spontaneous bowel movement per week; and one or more of the following symptoms/signs during~     more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1)~     straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion~     criteria are: Loose or watery stool in the absence of laxative use for more than 25% of~     bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of~     6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria~     for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological~     pathologies; Psychiatric conditions; Chronic use of medication with a gastro~     intestinal-activity.~   "
111248|NCT01599143|"~     Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon~     Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to~     conventional treatment for patients suffering from many diverse chronic ailments. Three~     decades of research have documented it's benefits, but few papers have focused on~     identifying which particular aspect of MBSR directly correlates with it's degree of~     therapeutic efficacy. This study will use 7 well validated questionnaires to compare~     participants responses prior to, and following completion of an eight-week MBSR program at~     the North York General Hospital, as well as follow-up results at 1 month and 1 year post~     completion of the MBSR group.~   "
111249|NCT01599130|"~     For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but~     without HBeAg loss, switching to peg-interferon may increase the response rate. In the~     investigators study, patients were divided into two groups. In Group A, patients continued~     entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a~     monotherapy for 48 weeks, then followed up 24 weeks.~   "
111250|NCT01599117|"~     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5~     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with~     heart failure with preserved ejection fraction (HFpEF).~   "
111251|NCT01599104|"~     This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension~   "
111252|NCT01599091|"~     Porphyromonas gingivalis is one of the major bacteria involved in the formation and~     progression of chronic periodontitis. Pathogens invading the gingiva face the host's innate~     immune system at first and later on the acquired immune system which includes secreted~     antibodies and specialized cells. Although both the arms of the immune system are~     coordinated to overcome the infection, there are several known mechanisms which help~     pathogens as Porphyromonas gingivalis evade immunity. As a result, inflammatory mediators~     secreted by immune cells cause tissue damage and lead the inflammation process towards~     chronicity instead of clearing the pathogen. Up till recently most of the studies focused on~     the role of macrophages, dendritic cells and lymphocytes at the response to periodontal~     pathogenic bacteria while the role of fibroblasts (the most abundant cell in the connective~     tissue) was less examined. Fibroblasts are spindle shaped cells which have the ability to~     produce extra cellular matrix and respond to growth factors and cytokines. They are able to~     affect cells in the infected tissue and contribute to immune response efficiency. As known~     in the case of lymphocytes, fibroblasts also vary in subtypes, each differs in phenotype,~     immune interactions, extra cellular matrix production and destruction, migration abilities~     and so on. Two main fibroblasts subtypes in the oral cavity originate in the gingival tissue~     and the periodontal ligament anchoring teeth to the surrounding alveolar bone. Amongst the~     differences between the two are collagen production ability and receptors profile over the~     cell surface. Considering all that, the investigators aim to obtain and use periodontal~     ligament and gingival tissues removed anyways during common dental procedures in order to~     extract the different fibroblasts subtypes residing there and compare their response to~     Porphyromonas gingivalis.~   "
111253|NCT01599078|"~     The purpose of this study is to assess the safety and efficacy of administering~     intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following~     percutaneous revascularization to prevent restenosis.~   "
111254|NCT01599065|"~     The purpose of this study is to compare the two options for management of ICDs (internal~     cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1)~     programming ICD therapies off, or (2) use of a magnet to suspend ICD therapies By~     comparing these two techniques the investigators hope to demonstrate the efficiency of using~     an ICD magnet protocol during perioperative management of patients undergoing electrocautery~     procedures. Secondary purposes are to gain further information on health care resources,~     incidence of EMI, handoff communications and to document lack of adverse events in either~     group.~      Primary objective will be: ICD therapy off times will be less with the use of a magnet~     protocol compared to an off-on protocol. Secondary objectives will be: (1) Healthcare~     resources (time and costs of skilled personnel) will be less using a magnet protocol~     compared to an off-on protocol, and (2) there will be no difference between adverse events~     in the magnet protocol compared to an off-on protocol. The incidence of EMI and number of~     handoff communications will be documented.~      The investigators hypothesis is that the number of minutes with ICD therapies off will be~     significantly less with magnet use. The investigators also expect health care resources to~     be less with magnet use compared to reprogramming.~   "
111255|NCT01599052|"~     There is ample evidence that children treated for a brain tumour (BT) often develop deficits~     in social and emotional functioning. The investigators wish to examine the cause of these~     deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment~     and developmental delay in social cognition (and related cognitive functions) caused by~     brain damage in patients treated for a BT in childhood as compared to a reference group of~     chronically ill children. If we can identify the specific deficits these patients~     experience, neuropsychological treatment and guidance can be developed to give patients the~     most optimal chances to live as normal as possible, to improve their quality of life (QoL)~     and to prevent them from developing depression and anxiety. Eventually, an intervention~     programme could be developed based on our results, to improve social, vocational and~     emotional QoL.~   "
111256|NCT01599039|"~     The goal of the study is to investigate the use of bio-impedance spectroscopy in the~     assessment of breast cancer related lymphoedema in patients operated with lumpectomy or~     mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water~     volumetry. As a control group, patients with colon rectal cancer are used to compare~     volumetric and spectometric changes during follow-up.~   "
111257|NCT01599026|"~     Good glycemic control is superior to poor glycemic control in reducing risk of~     interventricular septum thickness among fetuses of diabetic mothers~   "
111258|NCT01599013|"~     This study is assessing the combination of well known cytotoxics with a novel anti-cancer~     agent that could be administered as monotherapy without renal toxicity in patients with~     renal impairment presenting with advanced or metastatic urothelial carcinoma previously~     treated with a platinum-based regimen. The intent of this study is to clarify the~     benefit/risk ratio of the two most promising associations of cytotoxics including the novel~     therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.~   "
111259|NCT01599000|"~     In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national~     first-line drug for uncomplicated malaria. The principal purpose of this study is to measure~     the absolute effectiveness of AL when used under real-life clinical conditions, as compared~     to optimized in-vivo trial conditions. This question was raised by the National Department~     of Health in preparation for the country-wide roll-out of AL.~      The study is designed as a randomized controlled trial comparing two study arms. Patients in~     the effectiveness arm receive the first dose of AL under full supervision in the clinic;~     the following doses will be taken at home, as in real-life clinical practice and according~     to the new national treatment guidelines. Patients in the efficacy arm will receive all~     doses of AL as directly observed treatment in the clinic in order to establish the efficacy~     of the drug when used under ideal conditions.~      The study will enroll outpatients aged 6 months to 10 years with a history of fever and a~     positive rapid test for malaria. Patients meeting all enrollment criteria and providing full~     written informed consent by a parent/caretaker will be randomized into either of the two~     study arms. Patients in both arms will be followed up actively for 42 days. Patients in the~     efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in~     the effectiveness arm on days 0, 3, 7, 14, 28 and 42.~   "
111260|NCT01598987|"~     This study was designed to assess the evolution of renal function and to collect efficacy,~     safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric~     liver transplant recipients.~   "
111261|NCT01600144|"~     Mammographical data collection (raw data) for CAD evaluation by VUCOMp software.~   "
111273|NCT01599988|"~     The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external~     representatives, legal representatives and appropriate individuals and ex-officio~     administrative members with needed expertise. Ethics Committee members, including the Chair,~     are appointed by the Head of College, University College Cork, Medical School.~      The Ethics Committee meets once a month.~   "
111262|NCT01600131|"~     Aims and Intervention:~      The long-term goal is to implement stroke caregiver programs that involve low-cost~     interventions that are sustainable in routine clinical practice. The immediate objective is~     to test, using a randomized controlled trial, a problem-solving intervention for stroke~     caregivers that can be delivered during the transitional care period (e.g., time which~     Veteran is discharged to home) followed by online, in-home sessions. The investigators will~     modify the traditional, problem-solving intervention by adding web-based training using~     interactive modules, factsheets, and tools on previously developed and nationally available~     RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also~     provide on-line, skills training and application of the problem-solving approach via the~     RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the~     intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline~     data collection. Aim #2 is to test the effect of the intervention on stroke caregivers'~     burden, positive aspects of caregiving, self-efficacy, health-related quality of life~     (HRQOL), and satisfaction with care at 11 and 19 weeks after baseline data collection. Aim~     #3 is to test the effect of the intervention on Veterans' outcomes: functional abilities and~     healthcare utilization (i.e., unintended hospital bed days of care, number of emergency room~     visits, number of unscheduled clinic visits) at 11 and 19 weeks after baseline data~     collection. Aim #4 is to determine the budgetary impact for implementing the intervention.~     Aim #5 is to determine the facilitators, barriers and best practices for implementing the~     intervention.~      Design and Methods:~      The investigators will conduct a two-group randomized controlled trial. The investigators~     will enroll 240 stroke caregivers at 5 study sites (North Florida/South Georgia Veterans~     Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa,~     Richmond VA Medical Center and Michael E. DeBakey VA Medical Center in Houston). Eligible~     caregivers will be interviewed, complete baseline measures, and then be randomized to two~     groups: 1) intervention group, or 2) standard care. A team member will telephone caregivers~     at 11 weeks and 19 weeks after baseline data collection to answer questions on instruments~     with established reliability and validity. Qualitative interviews will be conducted with~     selected caregivers to obtain in-depth perceptions of the value, facilitators, and barriers~     of the intervention.~      Impact:~      This is the first known study to test a transition-to-home intervention combined with~     technology to improve the quality of caregiving and the recovery of Veterans.~   "
111263|NCT01600118|"~     This randomized clinical trial investigates the effect of the extracorporeal shockwave~     therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically~     approved non invasive method to influence bone turnover and tissue regeneration. The~     hypotheses of this trial are that ESWT increases the periodontal stability of~     orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal~     stability would reduce the retention phase, relapse risk and accelerate the rehabilitation~     of the surrounding tissues.~   "
111264|NCT01600105|"~     Patients with chronic liver disease are at high risk of developing liver scarring~     (fibrosis), with ultimate risks of cirrhosis and liver cancer that may require liver~     transplant. The investigators would like to develop non invasive advanced Magnetic Resonance~     Imaging (MRI) techniques (MR diffusion, perfusion and elastography) to assess the degree of~     liver damage in patients with chronic liver disease. These techniques combined could reach~     high diagnostic performance for detection of liver fibrosis; and could decrease the number~     of liver biopsies, which have risks and sample only a small portion of the liver.~   "
111265|NCT01600092|"~     A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™~     with the existing formulation in infants. The primary hypothesis of the study is that the~     new formulation will be noninferior to the existing formulation on the basis of~     immunogenicity.~   "
111266|NCT01600079|"~     This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of~     herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared~     to a cohort of unvaccinated participants.~   "
111267|NCT01600066|"~     Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies~     suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may~     reverse erectile dysfunction in affected patients. The present study aims to investigate in~     a larger cohort if severe sleep apnea is independently associated with erectile dysfunction~     and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.~   "
111268|NCT01600053|"~     The purpose of this study is to determine whether on course (6 cycles) of consolidation~     therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in~     the bone marrow.~   "
111269|NCT01600040|"~     Proton beam radiation therapy is known to spare surrounding normal tissues from radiation.~     Proton beam radiation delivers less radiation beyond the area of the target tissues. This~     may reduce side effects that patients would normally experience with standard (photon)~     radiation therapy which tends to unavoidably include more normal tissue along with tumor~     target tissue.~      In this research study, the investigators are looking to determine if proton beam radiation~     is effective in controlling your cancer growth. The investigators are also looking to see if~     proton beam radiation can reduce side effects when compared to standard radiation treatment~     (photon radiation).~   "
111270|NCT01600027|"~     Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures~     of the mid-third of the femur which are intensely painful. The pain of the fracture is~     thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps~     mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no~     need for high-skill or expensive equipments. It has higher success rate in more than 90%of~     the children thigh procedures.~      Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective~     α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine~     and much less α1 effects, which is responsible for the hypnotic and analgesic effects.~     Perinural dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and~     motor block without neurotoxicity in experimental studies.It has been reported to improve~     the quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe~     and effective in IV regional anesthetic and axillary block in adult. No study-up to the date~     -has been carried to evaluate its effect on the character of fascia iliaca compartment~     blocks as adjuvant to bupivacaine. The objectives of this study were designed to detect the~     effects of addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia~     iliaca block on the quality of postoperative analgesia and also to determine its effects on~     the hemodynamics, recovery behaviors, sedation and possible side effects in children~     undergoing thigh surgeries (fracture femur).~   "
111271|NCT01600014|"~     The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in~     treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging~     in a previously cleared field.~   "
111272|NCT01600001|"~     The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic~     Idiopathic Constipation (CIC) patients.~   "
111319|NCT01599390|"~     The study will assess the burden of severe influenza outcomes by age, risk status, and~     influenza subtype, in order to create a profile of the burden of influenza-related morbidity~     and mortality in United States from July 1997 to April 2009.~   "
111274|NCT01599975|"~     This study is being done to see if a drug called long acting methylphenidate (Concerta) is~     safe and effective as a treatment for problems with mental function in adults infected with~     HIV.~      A subset of patients with HIV-associated memory loss have a defect in the speed with which~     they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have~     been shown on tests to improve the ability to rapidly absorb information; these tests are~     called reaction time tests. These drugs are already FDA-approved to treat Attention~     Deficit Disorders: ADD or ADHD.~      At baseline, all subjects get tests of memory and brain function; then they are split into~     two groups. One group on this study will receive Concerta for 2 weeks, and a second group~     will receive a placebo x 2 weeks. After that period both groups will receive memory and~     other tests of brain function, and then the groups will switch. The first group will receive~     placebo and the second will receive Concerta x 2 weeks, followed by more memory and~     neurological tests. After that all subjects will have the option to receive Concerta for~     free for 8 more weeks. At the last visit all subjects get memory and brain tests again.~   "
111275|NCT01599962|"~     To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in~     healthy humans.~   "
111276|NCT01599949|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients~     with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy~     regimen and who progressed after bortezomib therapy.~   "
111277|NCT01599936|"~     There is no FDA approved therapy for the treatment of scorpion envenomation. Centruroides~     scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity~     ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a~     clinical syndrome which may require sedation with benzodiazepines and observation for 6 to~     28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression~     of symptoms early in the clinical course while avoiding the clinical deterioration that can~     occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more~     effective than the present standard of care, midazolam, and faster-acting thus eliminating~     the need to transport most rural patients and reducing hospitalization time.~   "
111278|NCT01599923|"~     There is no FDA approved therapy for the treatment of scorpion envenomation in the United~     States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a~     spectrum of severity ranging from trivial to life threatening. Patients stung by~     Centruroides scorpions develop a clinical syndrome which may require sedation with~     benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe~     therapy is necessary to halt the progression of symptoms early in the clinical course while~     avoiding the clinical deterioration that can occur en route to a tertiary facility.~     Alacramyn® is anticipated to be safer and more effective than the present standard of care~     in the United States, midazolam, and faster-acting thus eliminating the need to transport~     most rural patients and reducing hospitalization time.~   "
111279|NCT01599910|"~     This study will evaluate the effect of scribes on an academic emergency department.~   "
111280|NCT01599897|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the~     recombinant four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with~     the adjuvant GLA-SE.~   "
111281|NCT01599884|"~     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is~     widely prescribed for patients with chronic obstructive pulmonary disease (COPD),~     particularly for those who have accompanying symptoms of chronic cough and sputum~     production. Randomized, placebo controlled indicate that it is safe and that it may have~     some clinical benefit when used at relatively low doses. It is postulated that substantially~     higher doses of NAC will be well-tolerated and will provide better symptom control while~     also decreasing blood makers of oxidant stress and inflammation.~   "
111282|NCT01599871|"~     The main objective of the study is to determine the effects of low-dose oral theophylline~     added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid~     (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of~     exacerbations defined as increase of symptoms that requires a change of medication~     (antibiotics and/or systemic glucocorticoid) or hospitalisation.~      DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel,~     prospective study. Patient will be recruited during an hospitalisation due to COPD~     exacerbation and randomised at the time of discharge to receive theophylline 100 mg or~     placebo on top of combination therapy with inhaled corticosteroids and long-acting beta~     agonist. The rate of exacerbations will be determined every three months up to one year~     follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of~     them, the following information will be obtained:~        -  Number/severity of exacerbations or hospitalisation since last clinic visit~        -  Compliance and side effects~        -  Blood sample~        -  Plasma levels of theophylline~        -  Sputum (induced)~        -  MMRC~        -  SGRQ~        -  Forced spirometry + inspiratory capacity~           - At the beginning and at the end of the study~        -  6MWT~        -  BMI~        -  BODE~   "
111283|NCT01599858|"~     The objectives of this study were:~      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to~     their effect on basal- and food- stimulated gastric pH in healthy volunteers.~      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to~     their effect on basal and meal stimulated pH.~      To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in~     healthy volunteers.~   "
111284|NCT01599845|"~     Investigation of the differences between the levels of extracellular and intracellular~     nano-particles in workers exposed to environmental particles during their employment to~     enhance understanding the process of penetration of the particles to respiratory epithelial~     cells.~   "
111285|NCT01599832|"~     The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride)~     (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure,~     and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved~     for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new~     blood vessel formation. The use of pazopanib described in this study is a standard of care,~     but the additional MRI and blood tests that will be performed are experimental~   "
111288|NCT01599793|"~     This study is being done to help researchers understand more about prostate cancer that has~     spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to~     better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone~     disease. The other purposes of the study are to better understand the effect of XL184 on~     prostate cancer progression, bone pain, and on any cancer cells that patients may have~     circulating within the blood (called circulating tumor cells)~   "
111289|NCT01599780|"~     This research investigates the ways in which preterm birth affects how very young children~     learn to speak and understand language, and how older children gain efficiency in language~     processing. The investigators observe how children at different ages learn new words and~     comprehend familiar words, how they communicate effectively with others, and how they use~     both linguistic and non-linguistic skills in problem-solving. All of the activities in the~     investigators' studies are designed to be age-appropriate and fun for children.~   "
111290|NCT01599767|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain associated with spinal cord injury. This study is part of the~     Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease~     in pain levels with active stimulation, when compared to sham stimulation, using a 3 week~     stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of~     stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also~     have follow ups at 2, 4 and 8 weeks after the second course of stimulation.~      If a subject receives sham during the experiment, he/she may enroll in an open-label portion~     of the study and receive 10 days of active stimulation.~   "
111291|NCT01599754|"~     The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or~     delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high~     risk patients.~   "
111292|NCT01599741|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes, shorter~     pulses and the introduction of automatic real-time motion compensation in subtraction~     imaging are used, which are known to positively influence image quality . The final effect~     on the clinical image quality in peripheral angiography is investigated in this study.~   "
111293|NCT01599728|"~     Despite modern advances in treatment, heart failure continues to carry a poor prognosis with~     high morbidity and mortality rates. Hence, there remains a major interest in the development~     of novel therapeutic agents for this debilitating condition. Urocortins have recently shot~     into limelight with their potential role in the pathophysiology and treatment of heart~     failure.~      Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that~     Urocortin 2 and 3 are potent arterial vasodilators, the effects of which are reproducible~     and well tolerated in healthy male volunteers. Previous studies using heart failure models~     in animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there~     is great scope for Urocortins as novel biomarkers and as potential therapeutic agents in~     heart failure. With this in mind, the investigators wish to study the local vasomotor~     effects of these peptides in greater detail in patients with heart failure.~   "
111294|NCT01599715|"~     More than one in three US women suffers from the distressing, embarrassing, and often~     unreported problem of urinary incontinence (UI). UI severity increases with age and the~     financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of~     the 2008 International Consultation on Incontinence concluded that pelvic floor muscle~     training (PFMT) should be offered as first line therapy to all women with stress, urge, or~     mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative~     strategies are low risk and differ from other forms of UI management in that they do not~     prejudice future treatments. They also may decrease symptoms of urgency and frequency that~     do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.~   "
111295|NCT01599702|"~     The study is a prospective, non-controlled, open-label multi-centre pilot safety study of~     iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory~     Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two~     treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will~     receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion,~     whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV~     iron isomaltoside 1000 divided into two administrations.~   "
111296|NCT01599689|"~     This pilot cluster-randomised controlled trial aims to determine whether the use of bedside~     mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium~     and improve outcomes in the older cardiac surgical patient.~   "
111297|NCT01599676|"~     The aim of this study is to assess the effect of citrulline supplementation on muscle~     strength in elderly institutionalized subjects undergoing a resistance exercise training~     program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.~   "
111298|NCT01599663|"~     The purpose of this study is to evaluate the effect of an algorithm, where ICU patients pain~     are assessed systematically with valid pain assessment tools and where pain is treated after~     pain intensity score.~   "
111299|NCT01599650|"~     This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing~     administered with or without adjunctive laser treatment versus laser photocoagulation (the~     current standard of care) up to Month 6 in patients with visual impairment due to ME~     secondary to BRVO. Additionally the results of this study will provide long-term (24-month)~     safety and efficacy data for ranibizumab, administered with or without adjunctive laser~     treatment in this indication.~   "
111300|NCT01599637|"~     The study is designed to explore the mode of action for omalizumab therapy in patients with~     chronic idiopathic urticaria.~   "
111320|NCT01599377|"~     The overall aim of the study is to establish bioequivalence between commercial tofacitinib~     tablet formulations with the tofacitinib capsule formulation.~   "
111321|NCT01599364|"~     The purpose of this study is to evaluate the virological efficacy of maintenance therapy~     with atazanavir with ritonavir combined with lamivudine in treatment experienced HIV~     positive patients with full and stable virological suppression.~   "
111301|NCT01599624|"~     The Stress Resilience Training System (SRTS) program is a stress reduction and resilience~     building system that blends cognitive training to anticipate the effects of stress with~     advanced biofeedback to mitigate stress effects and aftereffects, using a game-based~     learning framework on an iPad platform.~      The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived~     stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and~     class/operational performance among United States Navy service members.~   "
111302|NCT01599611|"~     The objective of this study was to investigate whether infants with total serum bilirubin >~     450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin~     encephalopathy develop long term sequelae with impairment of motor development, hearing and~     executive function compared with a control group.~   "
111303|NCT01599598|"~     Military operations and training situations present many physical and psychological~     challenges for service members to adapt to and overcome. The challenges of these changing~     conditions necessitate having to cope with stress, which is seen as the negative~     perceptions, feelings, and emotions that manifest from the subjective physical and/or mental~     strain on life processes. In addition, service members are returning from deployments having~     gone through traumatic experiences that can develop into posttraumatic stress disorder~     (PTSD), depression or other serious conditions. The Surface Warfare Independent Duty~     Corpsman (IDC) School is an example of a training environment where some students may be~     entering the program with symptoms of PTSD, which may preclude or make it more difficult for~     them to perform well. Autonomic nervous system (ANS) dysregulation has been observed in~     patients with PTSD and those experiencing chronic stress, such that there is more arousing,~     sympathetic input to the heart than calming, parasympathetic input, which is usually the~     dominant division of the ANS involved in controlling one's heart rate. The IDC training~     program is an example of an environment where the service member is expected to excel while~     being subjected to multiple sources of stress. The fast tempo coupled with performance~     expectations may induce stress and actually inhibit learning. The Institute of HeartMath has~     developed the Coherence Advantage program which teaches one to self-regulate their emotions~     while focusing on breathing to compliment the active process of self-regulation. In~     conjunction, the emWave Personal Stress Reliever allows the user to receive heart rate~     variability (HRV) biofeedback, hence giving the user the opportunity to self-regulate their~     ANS through breathing and self-regulation techniques. The proposed study will test the~     effectiveness of the Coherence Advantage program versus progressive muscle relaxation (PMR)~     in reducing stress symptomatology among Surface Warfare IDC students. The effectiveness of~     these two different interventions will be compared on outcomes of PTSD, depression, anxiety,~     sleep quality, perceived stress, attrition, and class performance.~   "
111304|NCT01599585|"~     This study will evaluate the effectiveness of a web-based behavioral activation(BA)~     treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans~     with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of~     in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of~     hopelessness and depression as in-person BA treatment for depression.~   "
111305|NCT01599572|"~     Background: Zinc supplementation has the potential to improve serum zinc levels and immunity~     of zinc deficient nursing home elderly.~      Objective: To determine the effect of zinc supplementation of 30mg/d for 3 months on serum~     zinc levels and T-cell mediated function of zinc deficient nursing home elderly.~      Design: This is a randomized, double-blind, placebo-controlled study. Outcome measures~     included change in serum zinc levels and various T-cell mediated immune factors between~     baseline and month 3.~      Hypotheses: The investigators hypothesize that zinc supplementation of 30mg/d for 3 months~     will improve serum zinc levels as well as various T-cell mediated immune factors in zinc~     deficient nursing home elderly.~   "
111306|NCT01599559|"~     Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and~     the monoclonal antibody rituximab (chemoimmunotherapy).~      Following chemoimmunotherapy patients receive radiation therapy if they have residues which~     may be active tumour. However at the end of chemoimmunotherapy the majority of patients show~     tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to~     be a good tool to accurately identify active tumor from scar tissue in patients treated for~     mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is~     really necessary in patients where PET/CT has shown that the tumor is no longer active.~     Therefore we will compare radiation treatment with careful observation.~      Patients that at the end of conventional treatment of chemoimmunotherapy have a negative~     PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to~     two different treatment groups: one treatment group will receive the radiation treatment,~     and the other treatment group will receive careful observation.~      The trial is planned according to a non-inferiority design aimed at demonstrating that~     progression free survival after the experimental treatment (observation) is not worse than~     after the standard comparator (mediastinal irradiation.Participation in this study could~     spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative)~     radiation therapy that may be unnecessary.~   "
111307|NCT01599546|"~     The purpose of this study is to understand reading abilities of children born preterm: their~     cognitive profiles, the neural basis of good and poor reading abilities, and the behavioral~     and neural factors that predict persistent difficulties. The investigators hope to learn~        -  what specific skills correlate reading skills~        -  if preterm children have different cognitive profiles than full term children with~          respect to reading~        -  if cognitive skills measured in kindergarten predict reading ability in the second~          grade~        -  if parts of the brain are associated with reading skill~        -  whether brain characteristics in kindergarten predict reading in second grade.~   "
111308|NCT01599533|"~     Many publications deal with the natural history of aortic aneurysms in literature. Except~     for connective tissue disorders as Marfan or Loeys-Dietz syndrome, aortic aneurysms are a~     complex multifactorial disease with genetic and environmental risk factors. Susceptibility~     loci identified in thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA) do~     not overlap, suggesting that different genetic risk factors contribute to these two forms of~     aneuryms. With a higher prevalence correlated to ageing (5%), AAA is usually presented as~     the degenerative form of the disease. However, a recent epidemiologic study by Olsson et al.~     has revealed an increasing incidence of thoracic aortic disease among older individuals~     (70+/-12 years) with 60% of aneurysmal rupture or dissection at diagnosis, and a 1.7 :1~     male-to-female ratio compared to 6:1 in AAA. From this current knowledge arises the concept~     of diffuse or plurisegmental degenerative aneurysmal aortic disease, poorly explored so far.~     As regards to the prevention policy, there is a consensus statement in which ultrasonography~     screening for AAA is recommended for all individuals aged > 60 years (particularly in men~     who have ever smoked) and for those aged > 50 years with family history of AAA.~     Nevertheless, screening for a concomittant thoracic location of the disease (except~     thoracoabdominal aneurysm) is not yet required, whereas it could change the prognosis of the~     patients and influence their management.~   "
111309|NCT01599520|"~     Cancer patients receiving chemotherapy experience a number of aversive symptoms that are~     accompanied by declines in physical and mental well-being. Although the benefits of stress~     management training interventions on quality of life are well documented, there are no~     published studies examining the efficacy of these interventions among Hispanic women and~     Latinas (hereafter referred to as Latinas) receiving chemotherapy. This dearth of research~     reflects the general lack of stress management interventions for cancer patients whose~     preferred language is Spanish. Simply translating existing English-language interventions~     into Spanish may seem to be a solution for the lack of Spanish-language stress management~     interventions. This approach, however, does not take into account cultural values, beliefs~     and situational realities that are likely to contribute to patients' uptake of health~     promoting behaviors. The proposed research seeks to address this gap by evaluating a stress~     management training intervention developed specifically for Latinas beginning chemotherapy~     for cancer.~      In response to the identified need, the investigators created a Spanish-Language~     Self-Administered Stress Management Training (SL-SAT) intervention Cómo tratar el estrés~     durante la quimioterapia (How to manage stress during chemotherapy). The intervention is~     based on an English-language self-administered stress management training intervention the~     investigators previously developed and showed to be efficacious in a randomized controlled~     trial. Development of the Spanish-language intervention was the result of extensive use of~     ethnographic and learner verification methods, guided by a community-based participatory~     research approach. Similar to the English-language version, the SL-SAT intervention consists~     of a digital video disc(DVD), booklet, and audio compact disc (CD), and provides instruction~     in three well-established stress management techniques: deep breathing; progressive muscle~     relaxation and guided imagery; and use of coping self-statements. The proposed study will~     evaluate the efficacy of this transcreated intervention in a randomized controlled trial~     involving Spanish-speaking Latinas about to begin chemotherapy for cancer. Following a~     baseline assessment, participants will receive usual care or usual care plus the SL-SAT~     intervention. Participants will be reassessed on study measures approximately 7 and 13 weeks~     after the baseline assessment.~   "
111310|NCT01599507|"~     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the~     correction of anemia in non-dialysis chronic kidney disease patients.~   "
111311|NCT01599494|"~     This study, conducted in India, will be recruiting women participants who are between the~     ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but~     have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection~     (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell)~     production after administration of the investigative drug, MK-8962 (corifollitropin alfa) +~     recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference~     drug, recFSH.~   "
111312|NCT01599481|"~     The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a~     model of supported employment (the Individual Career Management (ICM) model) designed to~     help people with common mental illness return to work.~   "
111313|NCT01599468|"~     The purpose of this study was to evaluate the effect of early administration of tranexamic~     acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section~     delivery.~      This was a randomised, placebo controlled trial including 74 patients. The investigators~     included ASA1 parturients with correct haemostatic status undergoing cesarean section under~     spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and~     starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg~     of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within~     the 2 following hours. Placebo Group received same volumes of normal saline. The~     investigators compared blood loss and transfusions in both groups.~   "
111314|NCT01599455|"~     Following spinal cord injury (SCI), the body loses normal control of blood pressure and~     heart rate, and there is a risk of sudden and dangerous increases in blood pressure, namely,~     autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and~     heart rates in individuals in order to detect AD. However, baseline values vary in~     developing children, and may be more variable in children with SCI. Thus, the objective of~     this study is to determine baseline blood pressure and heart rate measurements in children~     with SCI during rest and during urodynamic testing.~      The investigators hypothesize that 1) blood pressures will increase with increasing age and~     body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will~     increase with increase in bladder filling; 4) blood pressures will increase will increase~     with increasing duration of injury.~   "
111315|NCT01599442|"~     Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous~     system), vascular, mechanic and metabolic factors, which are further complicated by an~     impairment of the immune system and a corresponding increase in the risk for infections.~     Results from clinical trials about the efficacy of interventions aimed at reducing the~     number of patient-relevant end points are of limited comparability due to the heterogenity~     of patient characteristics. By their very nature, randomized clinical trials (RCT) can only~     focus on a limited section of the wide range of possible intervention regimes. In clinical~     practice, however, a number of patients with dfs will never have been part of a clinical~     trial. Furthermore, there are only very few contemporary registers for this indication from~     which conclusions with regard to the comparative merits of different therapeutic strategies~     may be drawn.~      The register was conceived to find out to which extent RCT patients are representative for~     the overall patient collective with dfs and critical limb ischemia and to evaluate the~     therapeutic success of other treatment strategies. An RCT to assess the efficacy of~     urokinase versus placebo is imbedded in the register.~   "
111316|NCT01599429|"~     Positron emission tomography uses various radioactive tracers to measure the metabolic~     activity in a none-invasive way, and specially to follow the activity of the disease during~     the treatments.~      Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool~     would allow to image and follow time wise acute myeloid leukemia (AML). The investigators~     want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic~     before and after chemotherapy treatment.~      The aim of this study is to be able to identify earlier the responders, because if they are~     detected sooner, these patients will benefit from more aggressive treatments.~   "
111317|NCT01599416|"~     The purpose of this study is to understand the effect of using oral U-relax on HPV infected~     women for vaginal environment health promotion, and the HPV DNA Test Index change from~     positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax~     contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on~     treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive~     result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of~     cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and~     patients with HPV DNA test positive result.~   "
111318|NCT01599403|"~     The primary objective of this study is to investigate whether continuous PVB is equal in~     efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2,~     or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs~     equal to or greater than 1.2.~   "
111322|NCT01599351|"~     The objective of this study is to evaluate the radiation dose to patient at two positions~     (prone and left lateral) and to medical staff during Endoscopic retrograde~     cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and~     thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and~     20 patients at left lateral position.~   "
111323|NCT01599338|"~     Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1~     analogues decrease satiety and food intake leading to a significant weight loss in patients.~     However, little is known about their effects on food hedonic sensations and taste~     perception.~      The aim of this study is to investigate the impact of Liraglutide on the liking and wanting~     components of the food reward system, taste sensitivity and sensory specific satiety in type~     2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models,~     it is expected that Liraglutide will modify food preference and gustative perception in~     humans.~      Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide~     (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the~     treatment administration. Olfactory liking, recalled liking and wanting for several food~     items will be assessed. Sensory specific satiety will be measured as well as detection~     thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on~     hunger, pleasure in eating, and food intake.~   "
111324|NCT01599325|"~     The purpose of the study is to determine whether azacitidine is safe and effective in the~     treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).~   "
111325|NCT01599312|"~     In this randomized crossover trial the investigators test whether three different brands of~     videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare~     them with a classic Macintosh laryngoscope blade.~   "
111326|NCT01599299|"~     The purpose of this study is to determine whether there is a difference between the~     diameter, and the cross-sectional area of the right internal in left internal jugular vein~     in preoperative, mechanically ventilated patients.~      Secondary the relationship between the internal jugular vein to the common carotid artery~     will be examined.~   "
111327|NCT01599286|"~     The overall objective of this drug trial is to determine whether treatment of acute~     hyperammonemia with N-carbamyl-L-glutamate (NCG, Carglumic acid, NCG) in propionic acidemia~     (PA), methylmalonic acidemia (MMA), late-onset CPS1 deficiency (CPSD) and late-onset~     Ornithine transcarbamylase deficiency (OTCD) accelerates the resolution of hyperammonemia~     efficiently and safely.~      The primary goal is to determine if the study drug (NCG) efficiently reduces ammonia levels~     following a hyperammonemia episode(s).~      Secondly, the investigators want to know if treatment with this study drug (NCG) efficiently~     improves neurologic function, reduces plasma glutamine levels and lessens the duration of~     hospitalization after each hyperammonemic episode.~   "
111328|NCT01599273|"~     Thyroid-associated ophthalmopathy (TAO) is an autoimmune process that can affect the orbital~     and periorbital tissues and the thyroid gland. Periorbital inflammation can cause swelling,~     fatty infiltration, and scarring of the eyelid muscles resulting in eyelid retraction and~     upper scleral exposure, which is the most common clinical features of TAO.Even with mild~     eyelid retraction and swelling, most patients become disappointed and depressed due to their~     cosmetically unacceptable appearance, and they are unwilling to wait for spontaneous~     resolution or a clinically inactive period for surgical intervention. Thus, most~     ophthalmologists and endocrinologists recommend surgery in the chronic burnt-out stage.~     Several treatment options have been described for correction of eyelid retraction, including~     Botox and filler injection, and surgeries in the burnt-out stage such as lowering the upper~     lid by recessing the levator muscle, excision of Müller's muscle, introducing a spacer, or~     myotomies.Surgical options have significant risks as well as an unpredictable course and~     outcome in some cases. Several authors have reported that subconjunctival botulinum toxin~     injection provides an immediate, effective treatment by reducing excessive levator function~     in patients who suffer from disfiguring eyelid appearance and do not want to wait for~     surgery for upper eyelid retraction.Botox treatment is usually temporary. However, unwanted~     ptosis, although temporary, was observed in five out of 24 patients (20.8%) in the study by~     Costa, which may be even more disappointing and cosmetically unacceptable to some~     patients.Recently, hyaluronic acid gel fillers, which were injected into the subconjunctival~     levator-Muller plane, demonstrated efficacy in managing Graves' eyelid retraction in three~     patients.However, complications such as a lumps, fluid buildup, and skin pigment darkening~     may occur using this technique.Steroid treatment represents a well-established TAO~     management strategy due to its anti-inflammatory and immunosuppressive actions. However,~     multiple systemic side effects such as diabetes, infection, hypertension, osteoporosis, and~     stomach ulcers are major drawbacks of systemic steroid treatment. Due to limitations of~     systemic steroid treatment, several studies reported TAO improvement with periorbital~     injections of methylprednisolone and triamcinolone, primarily focusing on reducing proptosis~     and diplopia. So far, however, only a single small case series study has suggested that an~     injection of 20 mg triamcinolone into the subconjunctival region of the lid, between the~     conjunctiva and Muller's muscle, improves upper eyelid retraction within 1 month in three of~     the four patients. The investigators are not aware of any study designed to demonstrate the~     treatment efficacy of locally administered triamcinolone to improve eyelid retraction and~     swelling in a prospective manner. Therefore, we aimed to evaluate both the short-term and~     long-term effects of subconjunctival triamcinolone injections in treating eyelid retraction~     and inflammatory swelling caused by TAO.~   "
111329|NCT01599260|"~     People with rheumatic disease often have decreased strength, muscle mass, and bone mineral~     density due to repeated bouts of inflammation, normal effects of aging, disuse, and~     inactivity. The medications used to quell the disease process, such as prednisone, can also~     have detrimental effects on body composition, strength, and functional capacity. The~     investigators propose to investigate the feasibility, safety, and effects of resistance~     exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique~     resistance protocol the investigators propose involves performing movements in a slow and~     controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of~     the resistance) to minimize force on the joints and connective tissues. This will be~     conducted in an individually-supervised environment with a new generation of exercise~     equipment that will accommodate their musculoskeletal capabilities and allow for~     reproducibility of the exercise protocol. The investigators intend to investigate the~     feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise~     protocol in older patients with rheumatoid arthritis and vasculitis by testing their~     strength, body composition, functional ability, mood, and quality of life before and after~     this 16-week resistance exercise intervention.~   "
111330|NCT01599247|"~     Specific aim #1: To assess the study team's ability to recruit subjects in this cohort and~     to successfully complete follow-up assessments by phone or mail.~      Hypothesis: Over 50% of eligible subjects will enroll in the observational study, and 70% of~     follow-up assessments will be successfully completed.~      Specific aim #2: To determine the natural history of hopelessness, ongoing suicidal~     thoughts, and optimism in subjects at 2, 4 and 8 weeks after discharge.~      Hypothesis: Subjects will continue to have moderate levels of hopelessness, suicidal~     thoughts, and optimism at follow-up assessments.~   "
111331|NCT01599234|"~     The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of~     spasticity in multiple sclerosis~   "
111332|NCT01599221|"~     This is an observational, retrospective and prospective study where subjects who have~     undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be~     followed for data collection since the day before their surgery (retrospectively) until day~     180 after surgery (retrospectively and prospectively).~      This study is aimed at collecting data from patients who have already been treated with EBA2~     nail. Data collection will cover the details of the fracture and surgery (from which the~     retrospective nature of the study), as well as details of follow up visits after surgery~     that patients routinely carry out up to 6 months (from which the prospective nature of the~     study).~      The study will be conducted in three clinical sites in Italy.~   "
111333|NCT01599208|"~     The goal of the proposed research is to map the effects—in particular facilitation—of~     Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the~     processing of associative memory. TMS technology has the potential to selectively enhance~     functions mediated by areas in the temporal cortex, including the MTL, known to be the~     primary neuronal seat of episodic memory. By using this technology the investigators can~     further our understanding of theoretical models of human memory (specifically regarding the~     role of Recollection and Familiarity processes), and additionally, provide a possible route~     to the recovery of some of memory loss typically observed in the elderly—namely, memory for~     associations. Given the MTL's critical role in human memory and facilitation-inducing~     qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory~     performance in young and elderly healthy participants.~   "
111334|NCT01599195|"~     The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect~     the presence of bruit by using an acoustic signal to represent the bruit. This pilot study~     will address two questions: is there a detectable difference in recorded sound signal of~     carotid and femoral bruit when compared to sound signals captured when there is no bruit~     present; is the use of a visual recorded signal more accurate in identifying carotid and~     femoral bruit when compared to traditional auscultation with a regular stethoscope and~     ultrasound.~   "
111335|NCT01599182|"~     This study will work towards understanding the changes in your body (metabolism) that~     develop with treatment in prostate cancer. Hormonal therapies such as ADT often result in~     detrimental changes in body composition, including lean tissue loss and fat gains, compared~     to those patients receiving radiation therapy. These changes in body composition are linked~     to risk of diabetes and cardiovascular disease in survivorship. The investigators will be~     evaluating 50 patients to primarily examine the changes in metabolism, nutrition, physical~     function and body composition at the end of treatment, 6 weeks and 6 months following the~     end of treatment. Patients will continue to be followed every 6 months for up to 5 years~     following the end of treatment. The investigators findings will provide a new perspective~     for future work and novel approaches in the treatment of prostate cancer.~   "
111336|NCT01598974|"~     Acupuncture has been used for many years to help relieve pain. However, it is not clear how~     acupuncture works. We are doing this study to learn about the effects of different forms of~     acupuncture on chronic low back pain. We are interested in learning about brain activity~     during pain. We plan to look at brain activity at the beginning and the end of the study,~     after 6 sessions of acupuncture.~   "
111337|NCT01598961|"~     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical~     outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular~     blockade should be performed or no neuromuscular blockade could be performed during LSR~     monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of~     different degree of partial neuromuscular blockade, including no neuromuscular blockade on~     the LSR monitoring for MVD surgery.~   "
111338|NCT01598948|"~     Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart~     disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of~     disease. In most patients life style modification together with lipid lowering drug therapy~     is sufficient to achieve this goal. In some patients with severe forms of~     hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis~     (a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug~     (apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe~     forms of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent~     mipomersen can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1~     of the study will test how 6 months of weekly therapy with mipomersen affects~     LDL-cholesterol in patients with severe LDL-hypercholesterolemia treated with regular~     apheresis. Phase 2 will test in how many patients this will result in a meaningful reduction~     of apheresis time, apheresis frequency or if apheresis can be stopped completely.~   "
111339|NCT01598935|"~     Today, there is an important lack of knowledge on the effects of dietary protein on protein~     metabolism after physical activity in children. Here, the investigators will measure changes~     in whole body protein metabolism using minimally invasive techniques and stable isotope~     methodology at rest and after physical activity with the intake of milk protein.~   "
111340|NCT01598922|"~     The purpose of this study is to understand the effectiveness of a ten-week internet-based~     cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and~     resilience skills, and cognitive processing.~   "
111341|NCT01598909|"~     Arnica ointment is currently used in homeopathic preparations for strains and bruises. In~     the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use~     Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent~     study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical~     outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment~     postoperatively will reduce the development of ecchymosis and improve outcome.~   "
111342|NCT01598896|"~     Cannabis use disorders are an important public health problem in the United States, but no~     effective pharmacotherapies are available to treat these disorders. People with~     schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen~     clinical outcomes in this group, making the identification of pharmacotherapy to treat~     cannabis dependence in those with schizophrenia important. The investigators intend to test~     the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist~     clonidine, for cannabis dependence in subjects with schizophrenia. The combination of~     dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing~     treatment-seeking outpatients to benefit from medical management (MM) sessions when they are~     trying to stop using cannabis. The investigators propose to assess the relationship of~     dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent~     patients with schizophrenia.~      Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and~     clonidine will significantly reduce cannabis use compared to those receiving placebo.~   "
111343|NCT01598883|"~     This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients~     undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The~     investigators will evaluate the hypothesis that AHR may be directly related to, modulated or~     mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one~     or more acute phase proteins. The investigators are particularly interested in identifying~     patients with true heparin resistance, that is, patients who demonstrate AHR even after~     antithrombin-replenishment in the presence of an adequate systemic dose of heparin.~   "
111344|NCT01598870|"~     The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial~     peritonitis and the decisional thresholds to start treatment. The accuracy of current~     diagnostic tests will be compared with that of new tests, which could potentially become~     more accurate reference standards. This could lead to the definition of a more accurate and~     effective diagnostic algorithm.~   "
111345|NCT01598857|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod~     when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel~     Vasculitis.~   "
111350|NCT01598792|"~     It is the investigators intention to investigate whether a specially designed vaccine, based~     on a genetically modified strain of the bacterium Listeria monocytogenes and called~     ADXS11-001 is safe to use and is able to boost the immune system of patients presenting with~     Human Papilloma Virus (HPV) associated oropharyngeal cancer (OPSCC). It is hoped that the~     vaccine will boost the immune system so that immune cells with cell killing properties are~     able to attack any cancer cells remaining after the patients have been treated. However, the~     vaccine is so novel the investigators are not sure whether it is able to do this and before~     they can answer that question in a larger group of patients they need to make sure that the~     vaccine is safe to use and has some effect on the immune system in the patients for whom~     they intend its ultimate use. In a previous study, patients with incurable cervix cancer~     which is caused by the same virus, were vaccinated with ADXS11-001. Although all patients~     vaccinated experienced flu-like symptoms, patients tolerated the vaccine well with no~     patient suffering long term adverse effects of vaccination. However, because the patients~     and cancer type was so different in this earlier study, the investigators need to test~     whether ADXS11-001 is also safe in patients with HPV associated OPSCC. That said, the~     earlier study guided the dosing schedule for the current study and patients entering the~     REALISTIC trial will receive lower doses than those administered to patients in the earlier~     cervix cancer study. It is hoped that by doing this, patients will experience fewer side~     effects of vaccination without reducing the chances of stimulating the immune system.~   "
111351|NCT01598779|"~     The summary of this study is to know which HPV types are present in genital warts in~     Argentinean population.~   "
111352|NCT01598766|"~     This study is a feasibility study to evaluate new technology to improve the MRI experience,~     with coils, sequences and software. Patients from the Principle Investigator's exam schedule~     are given the opportunity to participate in this study is their MRI exam is appropriate for~     the specific coil, sequence or software being evaluated. If they agree, they can receive~     their MRI exam with the new coil, sequence or software instead of the standard one.~   "
111353|NCT01598753|"~     This is a randomized control study that involves a combination of a drug treatment,~     behavioral health, and placebo controls.~      Some participants will receive a medication approved by the Food and Drug Administration for~     treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive~     an inactive pill, called a placebo. There will also be 2 different types of behavioral~     health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which~     have been recommended for the treatment of patients with FM by the American Pain Society.~      There are 4 possible study treatment combinations:~        1. Tramadol + CBT,~        2. Tramadol + HE,~        3. Placebo + CBT,~        4. Placebo + HE.~      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there~     have been no studies that have evaluated the combination of medication and a behavioral~     health treatment. The primary purpose of this study is to compare the benefits of the 4~     combinations listed.~   "
111354|NCT01598740|"~     The purpose of this study is to determine the effects of CLP, with and without~     spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic~     kidney disease.~   "
111355|NCT01598727|"~     Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection~     of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid~     surgery.~      Aims: The aims of this phase of the study are to determine the feasibility of using near~     infrared fluorescent technology in the detection of parathyroid tissue and its~     differentiation from adjacent soft tissue during surgery on parathyroid glands.~      Objectives of the phase I study:~        1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device~          (Fluoptics).~        2. To understand the patterns (onset, intensity and duration) of fluorescent staining of~          normal parathyroid glands, thyroid glands and other soft tissue structures encountered~          during parathyroidectomy.~      Further research:~      This will be followed by a phase II study during which fluorescent imaging will be used in~     conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and~     parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum~     possible dose of MB for the identification of parathyroid glands. This will then be tested~     in the pilot phase of a randomized clinical trial.~   "
111356|NCT01598714|"~     This study compares patient satisfaction in terms of pain relief, mobility and ease of use~     between 3 commonly used types of post-surgical footwear. This study randomises patients who~     participate into one of 3 groups of footwear, namely Darco, Podalux or standard dressing~     shoe. Number of patients enrolled is determined by power calculation. Patients complete a~     single, simple previously validated questionnaire the MOXFQ (Manchester-Oxford Foot~     Questionnaire) at their 6 week follow-up appointment and statistical differences between the~     group are calculated using a significance level of p<0.05. This study will help us determine~     the best foot-wear to offer the investigators post-surgical patients.~      This study will form original research.~   "
111357|NCT01598701|"~     The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an~     effective adjunct therapeutic agent in patients undergoing craniotomy.~   "
111358|NCT01598688|"~     The purpose of this study is to verify whether differences exist in cyclosporine levels~     between the samples collected through peripheral venous access, the catheter line used to~     infuse the drug and the line not used for infusion immediately after interrupting the drug~     infusion or five minutes after the interruption.~   "
111359|NCT01598675|"~     Many of the 780,000 people affected by stroke each year are left with slow, asymmetric~     walking patterns. The proposed project will evaluate the effectiveness of two competing~     motor learning approaches to restore symmetric gait for faster, more efficient, and safer~     walking.~   "
111360|NCT01598662|"~     This is randomized controlled trial designed for pregnant women who deliver vaginally at the~     University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted~     for postpartum contraception. After informed consent is obtained, eligible study~     participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or~     within 10 minutes of delivery of the placenta following a normal vaginal delivery. The~     investigators seek to determine the expulsion rate and complication rate in subjects with~     IUD immediately after placental delivery compared to insertion at six weeks postpartum or~     later. The investigators hypothesize that immediate placement safe and has an acceptably low~     expulsion rate to merit earlier placement in the indigent population.~   "
111362|NCT01598636|"~     The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL)~     surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the~     tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock~     problems in the antero-medial part of the tibia as often encountered in ACL revision~     surgery. In ACL revision surgery it is often impossible to perform a one-stage revision~     surgery procedure due to bone stock deficiency in the antero-medial side of the tibia. It is~     hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a~     one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel~     technique allows better graft fixation in two-stage ACL revision surgery. Several~     biomechanical studies proved biomechanical superiority of the new technique compared to the~     classical technique.~   "
111363|NCT01598623|"~     The objectives of the study are:~        1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on~          social functioning in schizophrenia.~        2. To evaluate the effect of socially oriented CBT administered to patients immediately~          after they receive OT, compared to patients who receive OT with not-socially oriented~          CBT, and compared to patients who receive socially oriented CBT without OT. The~          investigators hypothesize that OT and socially oriented CBT will have a synergistic~          effect, and will be better than OT or CBT alone.~        3. Use a detailed, in depth analysis of social interaction to assess these putative~          effects of OT. The investigators hypothesize that the use of this analysis will show~          larger treatment effects of OT than previously shown in less sensitive assessments,~          such as PANSS.~        4. To assess the effect of epigenetic status on response to OT. The investigators~          hypothesize that epigenetic variants associated with lower OT plasma levels will be~          associated with greater response to OT treatment.~        5. To assess in the relationships between levels of salivary OT and vasopressin, and~          social interactions in schizophrenia.~        6. To assess in the relationships between levels of salivary OT and vasopressin, and~          response to OT treatment.~   "
111364|NCT01598610|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
111365|NCT01598597|"~     This pilot, non-interventional, observational, Web-based, prospective cohort study is~     designed to collect self-reported safety and effectiveness and genetic data from subjects~     with locally recurrent breast cancer (BC) or metastatic breast cancer (MBC), metastatic~     colorectal cancer (MCRC), metastatic non-squamous non-small cell lung cancer (MNSCLC),~     recurrent glioblastoma (RGBM), or metastatic renal cell cancer (MRCC) in the United States~     who have been previously treated with Avastin (bevacizumab). The cohort will be composed of~     male and female subjects who have been diagnosed with locally recurrent BC or MBC, MCRC,~     MNSCLC, RGBM, or MRCC who have received treatment with bevacizumab in combination with~     chemotherapy, which started prior to or up to 31 December 2012. Participants will be~     self-referred to this study. They will be recruited online via a number of sources,~     including through the involvement of patient advocacy groups, social media tools,~     traditional media, physicians, and events to raise awareness of this study. After~     appropriate informed consent and authorization are obtained, data will be collected directly~     from subjects in an online survey. Participants will be contacted electronically to complete~     quarterly follow-up surveys. The follow-up period will be 1 year from responding to the~     baseline survey. DNA collection will be performed as part of this study. DNA will be~     extracted from saliva, which will be provided by the subject utilizing a collection kit sent~     to the participants for at-home use.~   "
111366|NCT01598584|"~     Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression~     has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has~     a high risk increase weight. So the investigators assume Mirtazapine would not only improve~     the anxiety and depression of metastasis pancreas cancer but also would improve the appetite~     of such patients which would improve dyscrasia of pancreas cancer patients. The drug may~     improve the quality of life in advanced pancreatic cancer which is of short survival.~   "
111367|NCT01598571|"~     Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer~     dose.~   "
111368|NCT01598558|"~     Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells.~     Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation~     of extent of disease and response to therapy than the current standard of care, F-18 FDG~     PET/CT.~      The main purpose of the study is to investigate a new PET/CT imaging probe for detection and~     follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma~     patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability,~     pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT~     in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to~     rituximab-based treatment in CD20-positive B-cell NHL~   "
111369|NCT01598545|"~     This study will investigate the dose of hydromorphone which will relieve the pain of women~     following a cesarean section when delivered directly in the area around the spinal cord~     (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal~     hydromorphone that results in a pain score of less than 3 out of 10 12 hours after~     intrathecal injection in 50% of women. Secondary objectives include determining the average~     amount of time patients obtain pain relief after injection. Other secondary objectives~     include determining the frequency and severity of side-effects associated with intrathecal~     administration of hydromorphone, including: bradycardia, hypotension, respiratory~     depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted~     to labor and delivery for planned cesarean section desiring will be consented for the study.~     The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential~     allocation method of statistical analysis will be used, meaning that each subsequent dose~     will be dependent upon the result obtained from the prior dose - ergo, if the initial~     subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the~     initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg~     more) of hydromorphone.~      After the intrathecal injection is given, patients will undergo their cesarean section. The~     patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.~     The patient's medical record will be reviewed to determine when she first requested~     supplemental pain medication. A pain score of less than three will be a positive result. A~     pain score of three or greater will be a negative result. Blood pressure, heart rate,~     arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be~     assessed.~   "
111370|NCT01598532|"~     The purpose of the study is to investigate whether transcranial, high-intensity LED placed~     on the scalp can improve working memory in people who have sustained a concussion with~     lingering effects or a mild brain injury.~   "
113466|NCT01570998|"~     This study proposes to study the efficacy and toxicity of breast radiotherapy given~     intra-operatively as a single dose after breast conserving surgery, with or without whole~     breast radiation as indicated by pathologic risk factors, in women with early stage breast~     cancer.~   "
111371|NCT01598519|"~     The primary aim of this study is to examine whether a school-based suicide intervention is~     effective in reducing suicide related risk factors in a population of middle and high~     students. It hypothesized that receiving the intervention will reduce the severity of~     suicide related risk factors such as depression, hopelessness, suicidal behaviors and~     increasing protective factors such as social support, self esteem, suicide knowledge and~     attitude and so on, as compared to the control group.~   "
111372|NCT01598506|"~     This study will investigate the dose of hydromorphone which will relieve the pain of women~     in labor when delivered directly in the area around the spinal cord (i.e., intrathecal~     injection). The primary objective is to determine the dose of intrathecal hydromorphone that~     results in a pain score of less than 3 out of 10 thirty minutes after intrathecal injection~     in 50% of women. Secondary objectives include determining this dose at five and ten minutes~     after injection. Thirty women admitted to labor and delivery for planned vaginal delivery~     desiring epidural placement will be consented for the study. The starting dose of~     intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of~     statistical analysis will be used, meaning that each subsequent dose will be dependent upon~     the result obtained from the prior dose - ergo, if the initial subject has pain relief, the~     second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have~     pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.~      After the intrathecal injection is given and the epidural is placed, visual analogue pain~     scores will be assessed 60 minutes following injection. A pain score of less than three will~     be a positive result. A pain score of three or greater will be a negative result. Blood~     pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects~     will also be assessed.~   "
111373|NCT01598493|"~     Background:~      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing~     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of~     activated carbon fiber impregnated with silver particles. The highly porous nature and the~     large specific surface area of activated carbon fiber provide a tremendous adsorptive~     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray~     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue~     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through~     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial~     investigates wound healing effects of BCT Antimicrobial Dressing on deep dermal burn~     patients.~      Aim:~      To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.~      Methods:~      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are~     diagnosed as deep dermal burn, the procedure of Informed Consent is conducted by the project~     investigator. As long as the patient agrees to join this clinical trial and signs the~     Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and~     distributed to the control and research groups respectively by coin flipping. The wound in~     the research group is first cleansed with normal saline and then applied with BCT~     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3~     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the~     wound is healed. Flamazine is applied on the wound in the control group instead and then~     covered with sterile gauze, and the frequency of dressing change is daily until the wound is~     recovered. The healed and non-healed area of wound is recorded and photographed every 3~     days, and the wound color and infection are also evaluated. On Day 12 and Day 21, compare~     the ratio of healing and non-healed areas in the control and research groups, and the ending~     point is set on the 21st day.~      Statistics Analysis:~      Paired Student's t-test will be performed to analyze the clinical data by comparing the~     difference of the healing percentage, the healing rate, the infection rate, and the~     frequency of dressing change. It is statistically significant when P<0.05.~   "
111374|NCT01598480|"~     Background:~      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing~     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of~     activated carbon fiber impregnated with silver particles. The highly porous nature and the~     large specific surface area of activated carbon fiber provide a tremendous adsorptive~     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray~     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue~     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through~     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial~     investigates wound healing effects of BCT Antimicrobial Dressing on superficial dermal burn~     patients.~      Aim:~      To investigate wound healing effects of BCT Antimicrobial Dressing on superficial dermal~     burn.~      Methods:~      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are~     diagnosed as superficial dermal burn, the procedure of Informed Consent is conducted by the~     project investigator. As long as the patient agrees to join this clinical trial and signs~     the Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and~     distributed to the control and research groups respectively by coin flipping. The wound in~     the research group is first cleansed with normal saline and then applied with BCT~     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3~     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the~     wound is healed. Flamazine is applied on the wound in the control group instead and then~     covered with sterile gauze, and the frequency of dressing change is daily until the wound is~     recovered. The healed and non-healed area of wound is recorded and photographed every 3~     days, and the wound color and infection are also evaluated. On Day 12 and Day 21, compare~     the ratio of healing and non-healed areas in the control and research groups, and the ending~     point is set on the 21st day.~      Statistics Analysis:~      Paired Student's t-test will be performed to analyze the clinical data by comparing the~     difference of the healing percentage, the healing rate, the infection rate, and the~     frequency of dressing change. It is statistically significant when P<0.05.~   "
111375|NCT01598467|"~     The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy~     for repair of pelvic organ prolapse in high volume european centers.~   "
111376|NCT01598454|"~     This study will be carried out in children with diagnosis of cancer with tumors known to~     express N-glycolylated gangliosides. The disease must be resistant to conventional therapy.~     The acute toxicity and immune response will be evaluated.~      The expression of N-glycolylated gangliosides in tumors has previously been investigated in~     the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in~     neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma.~      Gliomas and the aforementioned tumor types have a very bad prognosis when conventional~     treatment is ineffective.~      New therapeutic strategies have thus been examined, and several immunotherapeutic~     approaches, including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines~     are currently being assessed.~      Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies~     in patients with melanoma, breast cancer and lung cancer.~      Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range.~     The 1 mg dose level was selected for the ensuing clinical studies.~      This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg,~     owing to the difference in body surface between an adult (1.73 sq. m in average) and the~     candidate population for this study (0.55 to 0.7 sq. m).~   "
111377|NCT01598441|"~     This study was designed to investigate treatment of postoperative pulmonary hypertension by~     iloprost inhalation in children with congenital heart defects. It was a controlled~     single-blind randomized multi-center prospective study in order to explore the efficacy of~     this method in the treatment and prevention of pediatric pulmonary hypertension after~     corrective open-heart surgery for congenital heart defects.~   "
111686|NCT01594411|"~     This is a prospective, multi-center study examining the clinical impact of the Corus® CAD~     assay in approximately 250 evaluable subjects with no history of obstructive coronary artery~     disease who now present with chest pain or anginal-equivalent symptoms to a primary care~     physician (PCP) for evaluation.~   "
111378|NCT01598428|"~     -  The purpose of this study is to evaluate effects of anterior capsule polishing on~          effective lens position (ELP) and actual axial movement of the intraocular lens (IOL)~          by measuring anterior chamber depth (ACD)~        -  patients with bilateral age-related cataract undergo bilateral uneventful cataract~          surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable~          IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd~          Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was~          measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical~          Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was~          defined as the root mean square (RMS) of the change in ELP at each visit.~   "
111379|NCT01598415|"~     Study objectives:~        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,~          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.~        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and~          tolerability of a single intra-articular dose of SAR113945.~   "
111380|NCT01598402|"~     Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have~     (during and shortly after this treatment) a high risk of developing pneumonia by aspiration.~     This pneumonia is often associated with a hospital admission and affects the quality of~     life.~      The purpose of the study, is to determine whether prophylactic antibiotics may decrease the~     development of pneumonia. Prophylactic antibiotics means that there are no signs of~     pneumonia are already~   "
111381|NCT01598389|"~     The purpose of this study was to compare weight-discordant siblings in eating in the absence~     of hunger, caloric compensation, and the quality of their habitual diet. The investigator~     hypothesized that, within families and controlling for age differences, overweight and obese~     siblings would show greater eating in the absence of hunger, poorer caloric compensation,~     and poorer diet quality (e.g., increased percent of energy from fat and caloric beverages)~     compared to normal-weight siblings.~   "
111382|NCT01598376|"~     Objective~      To investigate the tissue reaction produced by implanted polyglactin suture material in~     normal human skin and to determine the effect of suture gauge on this response.~      Design~      A prospective, double blind, randomized clinical trial using a novel ethical study design.~     Both the patient and clinician analyzing the histology were blinded to the suture gauge~     used.~      Participants~      A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional~     entropion and horizontal eyelid laxity, who provided written consent to participate, were~     enrolled in the study.~      Intervention~      Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms~     were alleviated during the wait for definitive surgery by the placement of temporary eyelid~     everting sutures including a test suture. After 28 days, entropion correction was achieved~     by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis~     was carried out, blind to the suture gauge used, on the excised eyelid containing the test~     suture.~      Main outcome measure~      Defined histological parameters of suture-related granulomas were measured at multiple~     levels. Data included granuloma outer diameter, central cellular diameter, giant cell number~     and area of fibrous coat (calculated from the coat diameter and thickness at multiple~     levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.~   "
111383|NCT01598363|"~     The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the~     pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant~     administration of bardoxolone methyl with digoxin or rosuvastatin.~   "
111384|NCT01598350|"~     On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long~     disability and increased risk for comorbidities.1 Individuals with DS are also susceptible~     to secondary physical impairments and limitations as a result of complications associated~     with joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary~     impairments such as pes planus (flat feet), weakened muscles, bony abnormalities and~     arthritis may lead to painful joints and feet. Additionally, children with DS often manifest~     deviations in gait as a result of physical limitations imposed by orthopedic and muscular~     deficiencies that may lead to decreased postural stability. These secondary losses in~     function, which exacerbate disabilities, may be preventable with the use of appropriate~     early interventions aimed at correcting abnormal joint alignment. Research exploring~     effective physical therapy interventions for adults and children with DS is currently very~     limited. However, the use of orthotic devices to support lax ligaments and hypotonic~     muscles, which are common manifestations of DS, is one accepted method of intervention for~     children within this population. Orthoses are variable in structure and the degree of~     support provided to the foot and ankle also differ between foot orthoses (FOs) and~     supramalleolar orthoses (SMOs). Previous studies have supported the effectiveness of~     orthoses on improving ankle and foot alignment, as well as gait parameters. However,~     disagreement currently exists concerning which type of orthotic device is most beneficial~     for the population of children with DS. Children with DS express variable degrees of joint~     laxity and hypotonicity, as well as differences in the severity of specific alignment~     abnormalities such as excessive pronation or calcaneal eversion.6 Current literature is~     insufficient for explaining differences in the benefits provided by FOs and SMOs and the~     specific indications for their use in children with DS is unclear.~      Study Aims This study will demonstrate the differences in structural outcomes provided by~     FOs and SMOs and develop specific criterion for matching individuals of differing orthopedic~     impairments with the most beneficial orthotic device.~   "
111385|NCT01598337|"~     This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel)~     on the incidence of early and intermediate graft patency after CABG.~   "
111386|NCT01598324|"~     This is an ancillary study to a clinical trial that is being conducted at Massachusetts~     General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy~     of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399).~     This observational study will involve magnetic resonance scans to examine brain chemistry~     (neurotransmitter levels), brain activity, and functional connections between brain regions~     before and after participating in the trial. The neurotransmitters of interest are~     glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive~     ziprasidone and individuals who receive an inactive placebo. Differences between~     participants who respond to standard antidepressants and those who require additional~     medication will also be examined. All participants will have a baseline magnetic resonance~     scan before starting medication. The second scan will be after 8 weeks of escitalopram~     treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or~     placebo (16 weeks after starting) for those who do not respond to escitalopram alone.~     Participants will complete standard rating scales for depression at each visit.~   "
111387|NCT01598311|"~     608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this~     study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will~     last for 10 days and participants will be followed up for at least 40 days and a maximum of~     100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as~     compared to vancomycin.~   "
111388|NCT01598298|"~     RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by~     hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than~     a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.~      PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works~     compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage~     breast cancer receiving hormone therapy.~   "
111389|NCT01598285|"~     GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100~     non-responders and 100 best responders) metastatic breast cancer patients, will search for~     specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response.~     Only patients suffering from metastatic (disseminated at the time of diagnosis) breast~     cancer, treated with bevacizumab, will be included.~        1. -To identify genetic variants as bevacizumab response predictors in metastatic breast~          cancer~        2. To identify miRNA signatures in whole blood as bevacizumab response predictors in~          metastatic breast cancer patients.~      The main endpoint will be progression-free survival (PFS)~      The duration of the study will be approximately 18 months~   "
111390|NCT01598272|"~     Determine the effects of 8 week Investigational Supplement on cellular detoxification and~     gene expression profiles~   "
111391|NCT01598259|"~     The specific aims of this investigation in children during burn rehabilitation include 1.)~     to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.)~     investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and~     3.) develop a new methodology specific for burn patients that accurately screens for the~     presence of intrinsic dyssomnia.~   "
111392|NCT01598246|"~     This is a prospective chart review of all extubations in the pediatric intensive care unit.~     Over a one year period all extubations in the unit are to be recorded on a designated form~     and standard variables charted and compared. All data will be collected from the chart,~     retrospectively after the extubation event. Patients who fail extubation will be compared to~     those who succeed. We aim to identify factors which contribute to extubation failures in the~     unit, to come up with a unit specific extubation policy~   "
111393|NCT01598233|"~     The purpose of this study is to evaluate the effects of intragastric balloon on bone,~     metabolic and respiratory parameters in 50 patients with metabolic syndrome.~   "
111394|NCT01598220|"~     The purpose of this study is to determine whether computer-assisted cognitive remediation~     therapy is effective in the treatment of cognitive deficits in schizophrenia.~   "
111395|NCT01598207|"~     Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is~     associated with poor quality of life and high health care expenditure of 8 Billion Dollars a~     year.~      Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological~     issues may cause NCCP.~      The mechanism(s) for pain continue to be explored and include central and peripheral~     hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on~     relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone,~     or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly~     there is a large unmet therapeutic need.~      Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main~     component of Cannabis acts through specific receptors, that are located primarily on central~     and peripheral neurons (including the enteric nervous system) and myenteric plexus where~     they modulate neurotransmitter release. Activation of these receptors reduces excitatory~     enteric transmission and may improve esophageal hyperreactivity and hypersensitivity, the~     hallmarks of NCCP.~      STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux~     chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and~     esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom~     diary and impedance planimetry. The primary outcome measure will be the frequency of chest~     pain episodes. Secondary outcome measures include improvement in esophageal sensory~     thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and~     global improvement of symptoms.~      HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in~     NCCP patients, when compared to placebo.~      AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a~     CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of~     action.~   "
111396|NCT01598194|"~     The goal of this clinical research study is to compare the performance of a newly available~     needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles~     to see which needle gives better diagnostic information for pancreatic lesions.~   "
111397|NCT01598181|"~     The purpose of this study is to investigate Transcranial Direct Current Stimulation as~     treatment method for pain in fibromyalgia.~   "
111398|NCT01598168|"~     Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with~     heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some~     patients develop an allergic reaction to heparin, a condition called heparin-induced~     thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was~     designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and~     death. The objective of this 200 patient study is to determine if a new blood thinner called~     rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not~     require blood testing, and had a low risk of bleeding when it was used to treat blood clots~     in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT,~     there will be two very important benefits. For patients with HIT, the benefit will be having~     a safe, and easy-to-use drug to protect them from developing further life or~     limb-threatening blood clots. For the Canadian health care system, the benefit will be~     having a drug that is much less expensive than the drugs currently used to treat HIT.~   "
111399|NCT01598155|"~     Seventy patients will be previously treated for moderate-to-severe periodontitis according~     to their individual needs. Thirty days after completion of periodontal treatment, these~     patients will be randomized to one of the following groups of periodic preventive~     maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and~     subgingival control (when necessary).~      The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis~     is that the effect of the supragingival control (conducted over 24 months) will be similar~     to the effect of the supra- and subgingival control combined, above the restoration and~     progression of periodontitis.~   "
111400|NCT01598142|"~     The single-operator wire-guided cannulation technique doesn't require an experienced~     assistant and precise coordination between the assistant and endoscopist.~   "
111401|NCT01598129|"~     The purpose of the study is to investigate the safety and the recommended dose for later use~     of an oncolytic adenovirus CGTG-102 in combination with low-dose oral cyclophosphamide in~     the treatment of advanced cancers.~   "
111402|NCT01598116|"~     Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all~     have the potential for significantly harmful side effects. The purpose of this study is to~     identify potential biomarkers that can be used to design clinical trials and accelerate the~     delivery of new treatment alternatives to children with hemangiomas.~   "
111403|NCT01598103|"~     This study will assess the safety, tolerability and efficacy of SAF312 in patients with~     overactive bladder disease due to spinal cord lesions. The overactive bladder of patients~     who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients~     poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be~     primarily determined via urodynamic measurements.~   "
111404|NCT01598090|"~     The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined~     with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis~     C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.~   "
111405|NCT01598077|"~     This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or~     recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV~     infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or~     HER2 overexpressing metastatic breast cancer or gastric cancer~   "
111406|NCT01598064|"~     Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the~     junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation;~     hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with~     portal hypertension often suffer from infections from intestinal flora, the investigators~     speculate that probiotics will be beneficial to those patients.~   "
111407|NCT01598051|"~     The objective of this study is to understand if Rivaroxaban can improve treatment~     satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real~     clinical practice.~      A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey~     will be conducted at month 0, 3, 6 using ACTS/TSQM.~      This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a~     local prospective and observational study of patients who have received Xarelto for SPAF.~   "
111408|NCT01598038|"~     The investigators hypothesize everolimus toxicities are linked to pharmacokinetic~     variabilities of everolimus. Thus, early detection of clinical or biological risk factors~     will lead to personalized dosage treatment and permit a better tolerance without altering~     efficacy.~   "
111409|NCT01598025|"~     Approximately 30% of patients who are candidates for bone marrow transplants do not have an~     HLA-matched, or close to matched, donor available. For this reason, doctors have been~     testing ways to make transplants from HLA-partially matched donors as safe and effective as~     transplants from HLA-matched donors.~      This study is being done to test the safety and the treatment results of a specific kind of~     transplant. In this transplant, blood from two donors will be used. Each donor will share~     one half of your HLA type. Blood from both donors will be transplanted at the same time.~   "
111410|NCT01598012|"~     Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it~     was used for antipain during menstruation or dysmenorrhea. This drug has been described by~     alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and~     showed clinical satisfied response. From review about this agent, it does not have clinical~     trial to prove its efficacy. So the author produce this research to study in efficacy of~     Ayurved Siriraj Prasaplai.~   "
111411|NCT01597999|"~     This study examines the additional benefits of magnetic resonance imaging (MRI) with~     Gadovist in early breast cancer with poor prognostic features.~   "
111412|NCT01597986|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.~   "
111413|NCT01597973|"~     Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are~     non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated~     to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or~     pneumonia due to at least one of the following gram-negative bacilli organisms:~     Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or~     Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively~     drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a~     subject has both BSI and pneumonia at the time of study enrollment, they will be included as~     a subject with pneumonia.~      Objectives:~      Primary:~      •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a~     carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality~     compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia~     due to XDR-GNB.~      Secondary:~      •Determine what treatment regimen (colistin monotherapy or colistin combined with a~     carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin~     resistance among XDR-GNB isolates during therapy.~   "
111414|NCT01597960|"~     The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and~     this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk. It~     is hoped that a better understanding of the value of this therapy will provide a sound~     scientific basis for including yoga in mainstream clinical practice. The investigators~     propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited~     from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an~     acute coronary syndrome. Those who agree will undergo a series of baseline and follow-up~     measurements. 20 Indian Asians and 20 Europeans will be randomized to the yoga intervention~     plus their standard cardiac rehabilitation programme (usual care), and the remaining 20~     Indian Asians and 20 Europeans will be randomized to usual care alone. Baseline and~     follow-up measurements will be performed on all participants. In order to determine the~     acute effects of yoga the group randomised to the yoga intervention will also undergo a~     series of acute tests before and after their first yoga session.~   "
111415|NCT01597947|"~     This is a double-blind, randomized, placebo-controlled, single ascending dose study to~     assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study~     will take place in the US at one clinical site.~   "
111416|NCT01597934|"~     Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result~     in faster and greater antiviral activity and lower rates of resistance emergence over~     maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders~     to LAM/LdT+ADV rescue therapy.~      Earlier switching to combination with the most potent regimen will be more effective to~     achieve virologic response(VR) and prevent further resistance emergence.~      All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be~     assessed at baseline and every three months thereafter. Evaluations at each visit will~     include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse~     events. At baseline and every six months thereafter, serum will be assayed for HBV serology.~     Genotypic analysis will be performed at baseline and 48 weeks.~   "
111417|NCT01597921|"~     The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of~     acute radiation dermatitis in patients with breast cancer receiving radiotherapy.~   "
111418|NCT01597908|"~     This is a two-arm, open-label, randomised, Phase III study comparing dabrafenib (GSK2118436)~     and trametinib (GSK1120212) combination therapy to vemurafenib. Subjects with histologically~     confirmed cutaneous melanoma that is either stage IIIc (unresectable) or stage IV, and BRAF~     V600E/K mutation positive will be screened for eligibility. Subjects who have had prior~     systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible~     although prior systemic treatment in the adjuvant setting will be allowed. Approximately 694~     subjects will be randomised 1:1 (combination therapy:vemurafenib). The primary endpoint is~     overall survival (OS) for subjects receiving the combination therapy compared with those~     receiving vemurafenib.~   "
111419|NCT01597895|"~     The purpose of this study is to determine the effect that telaprevir and boceprevir has on~     the pharmacokinetics of maraviroc.~   "
111420|NCT01597882|"~     The UK population is ageing and the likelihood of having a long term health condition~     increases with age. Three out of every five people over 60 in the UK have a long term~     condition. Ageing and having a long term condition increases the chance of having difficulty~     being independent and carrying out day to day activities. In recent years the NHS has made a~     greater effort to prevent these difficulties in patients with long term conditions.~      One approach to help patients with long term conditions is case management, where by~     (usually) a community matron visits patients at home, looking for early warning signs of any~     worsening of their condition and arranging care and treatment. But the current way this is~     done varies across the country and hospital admissions are still rising. In order to give~     the right care at the right time, effective monitoring is needed to help the community~     matron detect and act on changes in the patient's condition.~      Loss of muscle strength in old age is linked to a poor health, but it is not known whether~     simple measures of muscle strength could be used to detect and predict declines in health in~     the short to medium term to help maintain independence and prevent an accident or hospital~     admission.~      The aim of this study is to look at whether monitoring muscle strength in case managed~     patients is practical, acceptable and useful in detecting when a patient's condition~     worsens. Each patient will be visited by the researcher in their home twice in the first~     week, then once every two weeks, for another 5 weeks, to carry out three simple measures of~     grip and respiratory strength, and complete questionnaires about their health and ability to~     carry out day to day activities. Each visit will last about 20 to 30 minutes. A small group~     of clinicians will be asked about their views of the strength measures. Database analysis~     will allow descriptive data on the patient group to be gathered and analysed.~   "
111421|NCT01597869|"~     The purpose of this study is to find all kinds of complications and it's frequency related~     to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to~     evaluate associated risk factors in patients who developed complications. The investigators~     performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All~     complications during or after the procedure will be recorded prospectively.~   "
111422|NCT01597856|"~     Veterans can apply for compensation and pension (C & P) benefits for a disability related to~     military service. The application exam for these benefits provides an opportunity for~     Veterans returning from service to access VA care. The investigators will recruit Veterans~     applying for C & P to participate in this study. All enrolled participants will complete~     questionnaires around the time of their C & P exam related to substance abuse, PTSD, service~     use, and attitudes. The investigators will monitor enrolled Veterans' attendance at~     treatment over time, and examine whether C & P award, substance use, and beliefs about~     benefits are related to treatment attendance. Some enrolled participants will be assigned to~     one of two study groups: a treatment group and a no-additional-treatment group. People~     assigned to these groups will complete the same substance abuse, PTSD, service use, and~     attitudes questionnaires two additional times during the study. Participants assigned to the~     treatment group will receive information about the relationship between substance use and~     PTSD and will be referred to relevant treatment. The investigators will test whether~     Veterans who receive no-additional-treatment have different symptoms over time and attend~     less treatment sessions (mental health or substance abuse) than people assigned to~     treatment.~   "
111423|NCT01597843|"~     This project will design, deliver, and evaluate a peer support intervention that will help~     veterans become familiar with and register for Veterans Health Administration (VHA) My~     HealtheVet (MHV). It will lay the groundwork for 2 types of future projects. First, the~     investigators will develop materials that can be used in other settings to increase~     registration, authentication, and meaningful use of MHV. Second, it will allow us to develop~     and study interventions that use informed, peer-supported Internet use to improve health~     behaviors and outcomes among veterans.~   "
111424|NCT01597830|"~     This study evaluates the effects of specialized footwear on pain and knee loading in knee~     osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and~     knee pain.~   "
111446|NCT01597544|"~     This study is divided into two parts. The first part is a prospective observational study of~     patients undergoing pelvic organ prolapse (POP) surgery. The goal is to determine patient~     preference between 3 different methods of bladder drainage in case of post-operative voiding~     dysfunction (POVD): transurethral indwelling catheterization (TIC), clean intermittent~     self-catheterization (CISC), and suprapubic tube (SPT). The second part of the study will be~     for those that choose CISC as their preferred method, whereby these patients will be~     randomized to receive CISC instruction either pre- or post-operatively to determine whether~     there is a difference in overall patient satisfaction based on timing of teaching.~      The investigators hypothesize that patients that receive informed consent pre-operatively~     will favour the use of SPT over TIC and CISC to manage potential POVD.~      Among those patients who opted for CISC in management of their post-operative voiding~     dysfunction, patients that are taught how to perform CISC pre-operatively in the clinic will~     have a higher level of satisfaction compared to those that are taught post-operatively in~     the hospital.~   "
111447|NCT01597531|"~     The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric~     banding can improve remission of type 2 diabetes.~   "
111425|NCT01597817|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by exacerbations~     and remission of intensely pruritic lesions of variable location. AD may be acute~     (short-term and severe) with predominantly redness, vesicles and oozing, or it may be~     chronic (long-term) with scaling, skin thickening, altered pigmentation and exaggerated~     surface markings. The condition affects mainly the creases of the elbows and knees, and the~     face and neck, although it can affect any part of the body. The severity of AD is variable,~     ranging from localized mild scaling to generalized involvement of the whole body. Itching is~     the predominant symptom, which can induce a vicious cycle of scratching, leading to skin~     damage. There is a tendency to lifelong dry sensitive skin. Skin of AD is often colonized by~     Staphylococcus aureus contributing to perpetuating cutaneous inflammation. AD treatment is~     based on skin hydration, identification and elimination of flare factors, and pharmacologic~     therapy. Biofunctional textiles are emerging as new and complementary tools . Chitosan is a~     natural polysaccharide with in vitro anti-microbial activity and regenerating properties.~     The investigators aim to evaluate the effect of a textile coated with chitosan in AD~     treatment as well as its impact on systemic inflammation and skin microbiome. The~     investigators hypothesize the use of biofunctional textile coated with chitosan will improve~     severity of AD , quality of life and diminish skin colonization with Staphylococcus aureus~     and some skin moulds, namely Malassezia.~   "
111426|NCT01597804|"~     This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical~     site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk~     of wound infection, extended length of hospital stay, readmission into the hospital, and the~     overall healthcare costs in patients undergoing surgery.~   "
111427|NCT01597791|"~     The investigators hypothesize that many parturients can, in fact, spontaneously micturate~     with low dose combined spinal epidural analgesic doses given for labor and that Foley~     catheterization is unnecessary in the majority of these parturients. At Prentice Women's~     Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those~     receive Foley catheters. By potentially reducing the necessity for Foley catheters, the~     investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract~     infections and urethritis leading to unnecessary treatment with antibiotics, as well as~     reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving~     low dose combined spinal epidural analgesia for analgesia after induction of labor who are~     randomized to a spontaneous micturition protocol will require fewer Foley catheter~     placements and demonstrate a lower incidence of positive urine culture postpartum than those~     who undergo standard Foley catheter placement.~   "
111428|NCT01597778|"~     Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or~     lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar~     tissue type can be used for HCT. This study will compare the effectiveness of two new types~     of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow~     donated from family members with only partially matched bone marrow; and, one that uses two~     partially matched cord blood units.~   "
111429|NCT01597765|"~     The purpose of this study is to determine the efficacy of antioxidant cocktails on the~     alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.~   "
111430|NCT01597752|"~     The objective of this study is to determine the biologic activity of a Blomia tropicalis~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
111431|NCT01597739|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in~     patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug~     (DMARD) therapy.~   "
111432|NCT01597726|"~     The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming~     to laminaria priming among women undergoing D&E at 13-20 weeks gestation in the Western Cape~     Province, South Africa~   "
111433|NCT01597713|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of~     NNC 0148-0000-0362 as tablets in healthy volunteers.~      The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362,~     placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC~     0148-0000-0362 administered orally or intravenously.~   "
111434|NCT01597700|"~     Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by~     Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of~     Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study.~     Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and~     given their informed consent will be entered into the study. They will be fasted and receive~     one tablet by mouth in accordance with a randomisation list and blood samples will be taken~     at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will~     receive the opposite tablet and the clinical process repeated. Subjects will be continuously~     monitored while in the trial clinic and at ambulatory visits with regular measurements of~     vital signs and questioned for adverse events. Drug concentrations will be analysed and~     these results compared to ascertain bioequivalence by applying statistical methods to the~     pharmacokinetic data; this information and all safety data will be formally reported.~   "
111435|NCT01597687|"~     This study aims to determine the burden of pertussis infection among adolescents and adults~     with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and~     Thailand. This study also aims to assess the health economic (HE) impact of pertussis.~   "
111436|NCT01597674|"~     The objective of the study was to assess whether the tolerance to the effect of YF476 on~     gastric pH observed with repeated doses in a previous study in healthy volunteers can be~     avoided by using smaller doses of YF476.~   "
111473|NCT01597180|"~     The purpose of this trial is to learn about potential interactions between raltegravir and a~     birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on~     steady state raltegravir containing highly active antiretroviral therapy (HAART), ages~     20-40, inclusive, who report regular monthly menses.~      The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE)~     and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular~     medical care. Women will be enrolled in the study for approximately 8 months.~   "
111437|NCT01597661|"~     Bupropion is a unique drug that is used both to treat depression and as an aid in smoking~     cessation. In 2008, the final report from the Bupropion pregnancy registry described 24~     congenital malformations among the 675 women exposed to bupropion in the first trimester of~     pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number~     of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of~     the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease~     Control and Prevention's case-control National Birth Defects Prevention Study, reported an~     increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that~     includes coarctation of the aorta and hypoplastic left heart syndrome.~      Data from the Slone Epidemiology Center Birth Defects Study will be used to test these~     observations. The outcomes of primary interest will include those hypothesized to be~     associated with bupropion in recent studies: left outflow tract defects considered as a~     group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined~     separately. All infants with congenital heart defects are further classified into subgroups~     that are embryologically meaningful, including left outflow tract defects. In secondary~     analyses, other heart defect classes for which there are adequate numbers of cases will be~     evaluated.~   "
111438|NCT01597648|"~     This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined~     Formulated Tablet compared with maraviroc and Combivir administered concurrently versus~     maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects~     complete dosing and critical assessments. The total duration of a subject's participation~     will be approximately 33 to 35 days, including a screening period (Day −21 to Day −1), 2~     treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a~     follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing~     period will begin the evening prior to dosing and extend until 48 hours (Day 3) after~     dosing. Subjects will be randomly assigned to receive 1 of the following 2 treatments in~     Period 1 then crossover to receive the alternate treatment in Period 2:~      In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and~     Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day~     washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine~     150 mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B~     consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an~     overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the~     morning after an overnight fast of at least 8 hours. Study drug will be administered with~     240 mL of water. Dosing in each treatment period will be separated by a minimum washout~     period of at least 7 days between doses. All subjects will undergo safety and other~     assessments. Subjects may be discharged after all study procedures are completed on the~     morning of Day 3, with instructions to return for the next study period or the follow-up~     visit, as appropriate. The follow-up visit will occur 7 to 14 days after the last dose of~     study drug in Period 2. Pharmacokinetic blood samples will be collected during each~     treatment period for evaluation of maraviroc, lamivudine, and zidovudine before dosing and~     at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total~     of 16 PK time points per treatment period). Protocol waivers or exemptions are not allowed,~     with the exception of immediate safety concerns. Therefore, adherence to the study protocol~     requirements, including those specified in the Time and Events Table, are essential and~     required for study conduct.~   "
111439|NCT01597635|"~     This is an early phase (phase IIa), randomized, multi-center study in subjects with acute~     lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study~     is to investigate the safety of GSK2586881 and to determine what effects it has on people~     with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).~      The study has two parts: Part A will be an open-label investigation in five subjects. Part B~     will be a double-blind, placebo controlled investigation and will involve approximately 60~     subjects.~   "
111440|NCT01597622|"~     This study provides subjects who complete the BEL113750 study and subjects who complete the~     open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of~     continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those~     randomized to belimumab, or the option to begin treatment with belimumab for those~     randomized to placebo, as an add-on to their standard of care SLE therapy.~   "
111441|NCT01597609|"~     Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark~     study to investigate the physiological changes associated with weight loss and regain. The~     aim is to estimate the changes in body composition during and after three interventions (i)~     calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted~     diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The~     interventions will last 12 weeks, after which there is a further 12 week observation period~     during which subjects will return to their normal lifestyle and are expected to regain~     weight. Additionally, a range of biomarkers may be evaluated to determine whether there are~     correlations at early and late time points with weight and fat loss and weight and fat~     regain. The changes in body composition and other biomarkers will be used to determine~     whether mathematical models can be built that predict the weight loss and regain of~     individual subjects. In addition, the usefulness of tools that may aid the physiological~     characterisation of weight loss/regain will be assessed, in particular methods for measuring~     energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion~     Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the~     Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition~     changes resulting from these typical weight loss interventions and predictive markers of~     response would facilitate the design of future studies for novel anti-obesity agents and~     allow earlier, more informed triaging of NCEs.~   "
111442|NCT01597596|"~     A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of~     alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who~     had been diagnosed with infantile-onset Pompe disease. Participants were treated with~     alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in~     the regions outside the US.~   "
111443|NCT01597583|"~     The main aim of this study is to conduct a randomized control trial to compare~     MobileMedMinder, a mobile phone based medication reminder software product, with currently~     accepted and empirically supported methods for increasing medication compliance through~     reminders and tracking.~   "
111444|NCT01597570|"~     It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access~     Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to~     hemstasis) and ambulation (TTA; Time to ambulation) at the puncture site of common femoral~     artery (CFA) after the procedures of Fastseal® Biosorbable Vascular Access Closure System or~     Perclose® ProGlide Suture-Mediated Closure System during 1 month observation.~   "
111445|NCT01597557|"~     The proposed study is designed to evaluate the effect of an intravenous infusion of~     magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in~     decreasing the energy threshold (in J) required for successful cardioversion of atrial~     fibrillation into sinus rhythm.~   "
113599|NCT01569269|"~     The purpose of this study is to test whether people with symptoms of chemotherapy-induced~     peripheral neuropathy (CIPN) receive physical or psychological benefits from participating~     in a six-week Reiki, Yoga, Meditation, or Educational experience.~   "
111448|NCT01597518|"~     The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of~     patients with acute SCI. The primary objective is to evaluate the superiority of riluzole,~     at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days~     after injury, as compared to placebo, in change between 180 days and baseline in motor~     outcomes as measured by International Standards for Neurological Classification of Spinal~     Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI,~     presenting to the hospital less than 12 hours after injury. Secondary objectives are to~     evaluate the effects of riluzole on overall neurologic recovery, sensory recovery,~     functional outcomes, quality of life outcomes, health utilities, mortality, and adverse~     events. The working hypothesis is that the riluzole treated subjects will experience~     superior motor, sensory, functional, and quality of life outcomes as compared to those~     receiving placebo, with an acceptable safety profile.~   "
111449|NCT01597505|"~     608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this~     study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will~     last for 10 days and participants will be followed up for at least 40 days and a maximum of~     100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as~     compared to vancomycin.~   "
111450|NCT01597492|"~     The purpose of this study is to assess the impact of belimumab on immune response to~     pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).~   "
111451|NCT01597479|"~     The aim of this clinical trial is to determinate if distal ultrasound guided peripheral~     nerve blocks on target nerves (radial and median nerve blocks at the elbow), using low~     volume and low concentration of long acting local anesthetic provide better postoperative~     pain control compare with systemic analgesia alone after thumb resection arthroplasty (TRA)~     due to a prolonged selective sensitive block on the tissue trauma.~   "
111452|NCT01597466|"~     The purpose of this study is to evaluate the use of the Epidrum device to identify the~     epidural space in patients requiring thoracic epidural analgesia.~   "
111453|NCT01597453|"~     NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60~     years. Patients, partners and the couple´s adult children who are at least 18 years old, are~     all invited to ultrasound examinations due to a standardized protocol.~      Parents of patients and partners are invited to return their answers of standardized~     questionnaires about clinical ischemic events such as stroke, angina or myocardial~     infarction or peripheral artery disease.~      Study inclusion time of patients and their families is 5 years. A biobank is build from~     samples from patients, partners and adult children. Clinical follow-ups for patients and~     partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are~     planned after 10 and 20 years.~      Hypotheses:~      What do patients know about their parents clinical ischemic events? How much established~     pathology in arteries do we find by a standardized ultrasound protocol at the time of~     ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings~     between patients and partners? Differences between children from families with several~     ischemic events among parents and grandparents vs. children from families without ischemic~     events? Biochemical markers related to ultrasound findings and artery disease.~   "
111454|NCT01597440|"~     Background: Very few drugs exist that treat hyperammonemia, specifically PA and MMA. Diet~     restrictions and alternate pathway agents are the current primary treatments, but they~     frequently fail to prohibit brain damage.~      Orthotopic liver transplantation cures the hyperammonemia of urea cycle disorders, but organ~     availability is limited and the procedure is highly invasive and requires life-long~     immunosuppression.~      A drug that could repair or stimulate a dysfunctional urea cycle such as this would have~     several advantages over current therapy. A drug called N-carbamyl-L-glutamate, Carglumic~     acid (NCG or Carbaglu)has recently been found to be virtually curative of another urea cycle~     defect called NAGS deficiency. In this disorder, treatment with NCG alone normalizes~     ureagenesis, blood ammonia and glutamine levels, allows normal protein tolerance and~     restores health. Knowledge from this study is being applied to acquired hyperammonemia,~     specifically in patients with propionic PA and MMA, to try and improve neurodevelopmental~     outcomes by improving the hyperammonemia.~      Aims: The overall objective of this project is to determine whether treatment of acute~     hyperammonemia with Carglumic acid in propionic acidemia (PA), methylmalonic acidemia (MMA)~     changes the long-term outcome of disease and to determine if it is effective in restoring~     urine ammonia levels to normal levels.~   "
111455|NCT01597427|"~     The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary~     artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.~   "
111456|NCT01597414|"~     Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic~     breast cancer. Chemotherapy however is associated with significant side-effects and can~     impact on Quality of Life and functionality in older patients.~      The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to~     delay or even avoid the use of classical chemotherapy because of competing risks of death in~     this frail/elderly patient group.~   "
111457|NCT01597401|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and~     pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural [5-HMF])~     compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be~     measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and~     laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red~     blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be~     assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated~     with oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo~     antisickling effects in a hypoxic environment, and by imaging related changes in tissue~     blood flow and oxygen levels.~   "
111458|NCT01597388|"~     The purpose of this study is to assess safety and tolerability of AZD2014 when given in~     combination with Fulvestrant.~   "
111565|NCT01595984|"~     The main objective of this protocol is to compare the impact on renal function of two~     different immunosuppressive regimens in patients with de novo renal transplant.~      Renal function will be accurately evaluated by measuring the clearance of iohexol.~      The protocol will also evaluate the efficacy and safety in a short term of these two~     different immunosuppressive regimens.~   "
111459|NCT01597375|"~     The investigators are doing this research study to find out if giving a drug called~     prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people~     with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every~     day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,~     severe runny nose, polyps in the nose, and develop allergic reactions if they take~     medications like aspirin.~      People with AERD can be desensitized to aspirin in order to be able to safely use it daily,~     but the investigators do not know if prasugrel may prevent reactions to aspirin and provide~     a safer way for people with AERD to tolerate aspirin.~      The investigators also want to understand what is different about the cells and urine from~     subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and~     subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want~     to understand how aspirin acts differently in subjects who have AERD, in comparison to~     subjects who have asthma but do not have AERD.~   "
111460|NCT01597362|"~     The study compares the Veress needle technique, the Direct trocar insertion and the Open~     technique with each other, in terms of minor complications, in elective laparoscopic~     procedures for benign pathologies.~   "
111461|NCT01597349|"~     The purpose of this research study is to learn how effective and safe FP01 lozenges are when~     given to subjects with a cough due to an upper respiratory tract infection. The study will~     include subjects who have an upper respiratory tract infection, with a cough of less than~     six weeks duration.~   "
111462|NCT01597336|"~     The objective of this study is to evaluate the utility of fibrinolysis when draining an~     abdominal abscess as defined by length of stay after drainage.~   "
111463|NCT01597323|"~     Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light~     based device for the treatment of facial wrinkles.~   "
111464|NCT01597310|"~     This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the~     CYP2C9 probe substrate warfarin in healthy volunteers.~   "
111465|NCT01597297|"~     The objectives of this study in Multiple Sclerosis (MS) participants treated with~     prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated~     with placebo are to assess the effect over 24 weeks on the following parameters to explore~     endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static~     balance, subjective impression of well-being, and participants' global impression of change~     in walking . Another purpose of this study is to evaluate the safety and tolerability of~     prolonged-release fampridine.~   "
111466|NCT01597284|"~     The investigators propose to evaluate the compliance of oral cancer therapies, particularly~     the possible link between this observance and cognitive function of patients at initiation~     of treatment. To our knowledge, this study will be among the first conducted on the issue in~     France and is an innovative approach in the management of cancer patients. The inclusion of~     cognitive dysfunction is part of a comprehensive approach to improving the quality of life~     and fully meets the objectives of both plans cancer, including those of the axis Living~     during and after cancer highlighted in the Cancer Plan~   "
111467|NCT01597258|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or~     efficacy of this drug.~   "
111468|NCT01597245|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to~     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.~   "
111469|NCT01597232|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or~     surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and~     10g/dL is necessary and important in clinical practice.~      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen~     consumption, the investigators hypothesize that index of transfusion trigger for patients~     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including~     infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired~     oxygen, core temperature, and angina. To verify this hypothesis, the investigators present~     West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according~     to the patient's history and monitoring parameters, and the investigators design a~     randomized controlled clinical trial to test this score.~   "
111470|NCT01597219|"~     This trial investigates stem cell transplants from partially mismatched donors in patients~     with blood and bone marrow cancers. The trial will test two kinds of transplants - a full~     intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced~     intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be~     entered for the treatment pathway that is most appropriate for their level of health and~     fitness~   "
111471|NCT01597206|"~     Dental services for large sectors of the population of the Western Cape (WC) Province of~     South Africa (SA) has been, and continues to be, limited to low-cost treatment options and~     emergency services, such as extractions at public health clinics. Replacement of missing~     teeth for the disadvantaged majority of the population is provided almost exclusively at the~     dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result~     of disease and the lack of restorative care and then having these replaced by a removable~     partial denture, if the patient can afford it Null Hypothesis: The daily functional needs~     and quality of life of partially dentate adult patients with a reduced posterior dental arch~     and /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the~     posterior teeth with a removable prosthesis.~   "
111472|NCT01597193|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in~     patients with incurable breast cancer.~   "
111566|NCT01595971|"~     The purpose of this study is to evaluate the effectiveness of multifaceted educational~     interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in~     teams of the Family Health Strategy and the consequent clinical improvement patients.~   "
111474|NCT01597167|"~     The proposed study is a 1-week, randomized, double-blind, placebo-controlled, trial to~     evaluate the efficacy of an IV infusion of magnesium sulfate on symptoms of treatment~     resistant mild and moderate depression in 20 males and females (21-70 years of age).~     Participants will be assessed at screening/baseline, day 1, day 2, day 7, and day 8. Each~     subject will be randomized in a double-blind fashion to receive either IV infusion of~     magnesium sulfate or 5% dextrose followed by a washout period of 5 days then crossover to~     receive either IV infusion of 5% dextrose or magnesium sulfate.~   "
111475|NCT01597154|"~     Background: Little is known about the efficacy of intensive lifestyle therapy (i.e.~     increased physical activity and dietary changes) for the management of glycemia and~     cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).~      Our hypothesis is that education regarding healthy lifestyle changes will significantly~     reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary~     hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions~     in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL~     cholesterol, serum triglycerides and apolipoprotein B.~   "
111476|NCT01597141|"~     The primary aim of this application is to conduct a randomized, controlled clinical trial of~     a specialized mental health service delivery system specifically developed for prodromal~     psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT).~     The goal of the treatment is prevention of psychosis and disability. This study will assess~     experimentally the clinical effectiveness of this new type of mental health service. Other~     domains of outcome include cognitive dysfunction and functional disability.~   "
111477|NCT01597128|"~     This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE®~     Reconstructive Tissue Matrixin the repair of hernias.~   "
111478|NCT01597115|"~     The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular~     access surgery with native vein for hemodialysis can increase the maturation rate of~     arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1~     randomized study. Enrolled patients will be randomized as a control group (Physical exam at~     2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4~     weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after~     surgery by duplex in all patients.~   "
111479|NCT01597102|"~     The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy.~     Patients with the indication to liver transplantation mostly have mild to severe hepatic~     encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is~     to investigate the AR during liver transplantation, with the questions if the AR is impaired~     at the beginning of surgery and if there are changes in AR. For follow up the AR will be~     measured at the first days after transplantation at the ICU.~   "
111480|NCT01597089|"~     Background:~      - Bronchoalveolar lavage (BAL) is a procedure where a tube is passed through the mouth or~     nose into the lungs. Fluid is squirted through the tube into a part of the lung and then~     collected for examination. It is used to detect respiratory viruses. BAL is a relatively~     invasive procedure, and researchers want to test the accuracy of other procedures that do~     not involve collecting fluid from the lungs. The nasopharynx is the area of the upper throat~     that lies behind the nose. Researchers want to see if a swab taken from this area is as~     accurate as a BAL sample.~      Objectives:~      - To see if a nasopharynx swab can be used to detect respiratory viruses as well as BAL~     samples.~      Eligibility:~      - Individuals at least 12 years of age who will have a bronchoscopy to collect a BAL sample~     to test for respiratory viruses.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a BAL sample collected.~        -  Participants will then have a nasopharynx swab. The swab will be inserted into the~          nose, left in place for up to 10 seconds, and then removed~   "
111481|NCT01597076|"~     The objectives of this clinical trial are to evaluate the effectiveness of an iridoid~     enriched beverage containing noni and cornelian juices and olive leaf extract on advanced~     glycation end product levels.~   "
111482|NCT01597063|"~     Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled.~     Study blood will be collected in the first or second trimester at a scheduled prenatal~     screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will~     be followed until delivery and the birth outcome recorded.~   "
111483|NCT01597050|"~     The purpose of this study is to determine the safety, efficacy and tolerability of topical~     R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)~     patients with active discoid lesions.~   "
111484|NCT01597037|"~     The purpose of this study is to evaluate how changing different conditions of the~     speech-language treatment (such as cues, feedback, complexity and practice schedule) affects~     the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension~     and expression of spoken and written language) following a stroke.~   "
111485|NCT01597024|"~     The primary aim of this work is, to 'relate psychological and behavioural parameters of~     hunger/satiety and food preference to gut hormones, neural activation and energy metabolism~     by dietary manipulation, across the human lifespan'.~   "
111486|NCT01597011|"~     In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is~     either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue~     (Tisseel/Tissucol) or left unfixated.~      The investigators believe, and previous studies indicate, that the use of fibrin glue~     greatly reduces the amount of postoperative complications (ex. chronic pain, impaired~     ejaculation in men or recurrence of the hernia)when compared with the use of tacks or~     staples.~      The aim of this study is to compare the recurrence rates and amount of postoperative~     complications in patients who have had inguinal hernia repair with fibrin glue and in~     patients who have had inguinal hernia repair with tacks, staples or sutures.~   "
111487|NCT01596998|"~     The aim of this study is to determine the effect of the addition of vasoconstrictor in the~     plasma concentrations achieved and the extent of the transversus abdominis plane block in~     healthy male volunteers.~   "
111567|NCT01595958|"~     The investigators hypothesised that cyclosporine A administration at the onset of~     cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore,~     could prevent the post cardiac arrest syndrome and improve outcomes.~   "
111488|NCT01596985|"~     Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation~     using the PlasmaJet system versus cystectomy, using postoperative examination by 3D~     ultrasound.~      Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two~     University tertiary referral centers.~      Patients: Fifty women with no previous history of ovarian surgery managed for unilateral~     ovarian endometrioma > 30 mm in diameter.~      Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian~     tissue sparing cystectomy.~      Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume~     and antral follicle count (AFC) .~   "
111489|NCT01596972|"~     The primary aim of this study is to determine if a self-administered semi-quantitative urine~     pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of~     women with a complete uterine evacuation who require a clinic or lab visit to confirm~     completion.~      The investigators hypothesize that women with complete uterine evacuation will be less~     likely to require a follow-up clinic or lab visit by using a standardized pregnancy~     questionnaire and home SQ-UPT, than by using serum hCG as the objective measure of~     completion.~   "
111490|NCT01596959|"~     This study will be a single blind prospective randomised control trial in patients~     undergoing ablation for the treatment of typical atrial flutter, with the aim of~     investigating the benefit of a new impedance-based computer software application which~     measures tissue contact between the ablation catheter and the inside of the heart.~      The investigators hope to demonstrate that the use of this tissue contact information~     reduces ablation time, Xray time, and procedure time required to complete the procedure~     successfully. Study participants will be randomly assigned to undergo their procedure with~     or without this contact data displayed for the doctor performing the ablation to see. The~     acute procedural endpoint of ablation is successful conduction block across the~     cavotricuspid isthmus of the right atrium. If the outcome of this study is positive, it will~     have a significant beneficial impact on this procedure, reducing procedure length, patient~     discomfort, and potentially reducing risk for the patient, recurrent arrythmia symptoms, and~     the need for repeat procedures later on.~   "
111491|NCT01596946|"~     Though partner notification is mandatory to perform of Chlamydia trachomatis infected~     individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997~     and 2007 indicating that partner notification may not be effective in preventing~     transmission. The investigators wanted to determine whether there was any difference in time~     between home-sampling and clinical testing as a tool of partner notification measured from~     eliciting of partners to date of testing.~   "
111492|NCT01596933|"~     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering~     from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly~     by cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour~     localisation can interfere with food intake, since alcohol and tobacco abuse - two~     etiological risk factors of H&N cancer - are associated with nutritional deficits, and since~     the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids~     have gained interest for their beneficial effects in several diseases. Moreover, nutritional~     supplementation enriched with omega-3 FA could potentially maintain body weight in cancer~     patients undergoing intensive treatment.~      Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation~     as nutritional and the investigators would like to identify potential risk factors,~     biomarkers and objective measurement tools which can predict therapy-induced cachexia.~   "
111493|NCT01596920|"~     The primary objective of the present study is to further establish in a randomized~     controlled trial, the safety and efficacy of weekly Grafix® administration versus control in~     patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure~     of the index wound, defined as 100% re-epithelialization as determined by the Investigator.~      Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue~     Based Product (HCT/P) under Title 21 CFR Part 1271.~   "
111494|NCT01596907|"~     Purpose is to determine the effect of ephedrine and caffeine, on metabolic rate and weight~     loss after bariatric surgery. Approximately 40% of patients struggle with their weight loss~     rate, or metabolic rate, after bariatric surgery, and at least 30% previously had or develop~     a low metabolic rate after surgery. Metabolic rate is the speed at which calories are~     burned. The fewer the calories eaten and the more calories burned, the more rapidly weight~     is lost. It is possible that despite a very low calorie intake following bariatric surgery~     metabolic rate will decrease so much so that weight does not decrease even if intake is~     reduced to 1000 calories per day. Ephedrine is a medicine used commonly to treat asthma,~     difficulty breathing, and wheezing. However, 40 years ago it was reported in scientific~     studies that ephedrine increases weight loss in patients on low calorie diets by increase~     the amount of calories that are burned. Combining caffeine with ephedrine makes ephedrine~     work more efficiently (more weight loss over time). Many studies show the effect of~     ephedrine on weight loss that began in 1974 with patients on food diets. Ephedrine used in~     various strengths and with a number of different combinations has shown to be effective and~     safe, especially when directed by a physician. There is only one study where ephedrine has~     been used in patients after bariatric surgery. In that study, both the patient and medical~     staff knew they were taking ephedrine (i.e., they were not blinded). The patients who were~     not losing weight or had measured low metabolic rates were treated with ephedrine. The~     patients taking ephedrine lost more weight after surgery than those not taking ephedrine.~     While this is a significant finding, the study was not designed to be the best test of the~     effects of ephedrine. The best test is where neither the patients nor the medical staff know~     if the patient is taking the active drug (double blind). All patients enrolled into the~     Research Study will receive capsules that contain either ephedrine and caffeine (the active~     drug) or identical capsules with no active ingredient (called a placebo). Neither group of~     patients will know which set of capsules they receive. The expected duration of treatment in~     the Study is 7 months from the day of surgery. This is a single site study. All patients~     will have their gastric bypass performed through Oregon Weight Loss Surgery at Legacy Good~     Samaritan Hospital. The investigators expect to study 200 patients with 100 receiving the~     study drugs (ephedrine and caffeine in a capsule) and 100 receiving placebo (inactive~     ingredients in an identical capsule) over approximately 6 months.~   "
111495|NCT01596894|"~     The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of~     Azithromycin combined with Metronidazole compared with 2 months antibiotic course of~     Metronidazole alone.~   "
111517|NCT01596608|"~     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and~     is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive~     disorder (OCD). However, its use is limited by significant adverse effects on memory and~     cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable~     pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is~     currently under investigation as a targetable, cognition-sparing alternative to ECT. MST~     uses magnetic fields rather than electrical stimuli for seizure induction, dramatically~     reducing the passage of induced current through undesired brain regions. 10 years of~     experimental studies have established the safety of MST in animal and human subjects. This~     pilot study will investigate whether MST has similar efficacy to ECT, with fewer cognitive~     side effects, in patients with severe depression, schizophrenia, and OCD.~   "
111496|NCT01596881|"~     Recent studies have shown that people with multiple sclerosis (MS) who also have diseases~     related to vascular health such as high cholesterol, high blood pressure, diabetes,~     cardiovascular disease, and others, may end up more disabled than people with MS who don't~     have those diseases. This has led to a growing interest in the role of vascular diseases in~     MS since they may provide another avenue of MS treatment. Some also think that vascular~     disease may even be a cause of MS. The back of the eye, the retina, is well-suited to~     studying vascular diseases as blood vessels can be seen even on routine examination of the~     eye by eye doctors. These specialists are used to seeing changes in retinal blood vessels~     due to diseases known to affect the eyes such as glaucoma and diabetes. Sophisticated~     techniques for examining the retina allow for not only visualization of blood vessels, but~     the rate of blood flow through the blood vessels as well. These blood flow changes are~     thought to come before changes in what the blood vessels look like, and so may be able to~     detect problems even earlier than routine examination of the retina by eye doctors. Retinal~     blood flow has never been carefully studied in MS. Given that MS affects the retina due to~     the late effects of inflammation of the optic nerve, or optic neuritis, the investigators~     expect to see altered blood flow in the retinal blood vessels of people with MS compared to~     healthy control subjects. If so, the investigators can then use retinal blood flow as a way~     to measure therapies that target vascular diseases in the MS population and determine if~     those therapies can alter the course of disease.~   "
111497|NCT01596868|"~     The present study is a randomized, control, phase II study of locally advanced~     nasopharyngeal carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin~     regimen (GP) or Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by~     concurrent chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal~     carcinoma (NPC). The effectiveness, side effects and quality of life will be evaluated~     according to Standard WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H&N35~     questionnaire.~   "
111498|NCT01596855|"~     The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining~     and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on~     maintenance hemodialysis and receiving epoetin alfa.~   "
111499|NCT01596842|"~     Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1,~     25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high~     dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D~     concentrations were significantly increased after 3 months of omega-3 FA supplementation~     compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients.~     In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D~     supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to~     25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or~     deficient 25-hydroxyvitamin D levels.~   "
111500|NCT01596829|"~     Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to~     antibiotic associated diarrhea. Previous studies have shown that the risk of developing~     diarrhea during a course of antibiotics may be reduced by simultaneous consumption of~     probiotics. The aim of the present study is to assess the effect of a probiotic formula~     containing four strains on reducing the risk of antibiotic associated diarrhea.~   "
111501|NCT01596816|"~     The aim of this study is to assess the safety of hypofractionated stereotactic boost~     radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).~   "
111502|NCT01596803|"~     On the basis of published data and the investigators' results indicating that oxidative~     stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD,~     the investigators propose a study to test whether or not an antioxidant supplementation has~     a therapeutic interest for patients with FSHD. Their results have important implications for~     the successful implementation of rational antioxidant therapy in FSHD in which cell loss~     could be linked to oxidative stress.~   "
111503|NCT01596790|"~     Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During~     these last years, many new chemotherapies and targeted therapies have been developed~     improving significantly the overall survival of patients. However, the choice of the~     therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers~     of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor~     of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers~     to propose the best personalized 1rst line therapeutic sequence. One idea would be to~     enumerate and characterize the circulating tumor cells (CTC) which, as it has been described~     in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer,~     would give us an early evaluation of the therapeutic efficiency. In this context, the~     investigators have developed an innovative technology, the EPISPOT assay (patent of the~     University Medical Center of Montpellier), that allows the detection & characterization of~     viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the~     breast and prostate cancer. Thus, the investigators would like to perform a prospective~     study on a cohort of patients with metastatic colorectal cancer to confirm, with this~     technology, the predictive value of CTC count for the efficacy of the treatment.~   "
111504|NCT01596777|"~     The purpose of this study is to describe the effects of methylnaltrexone in preventing~     loperamide-induced delay of the oro-cecal and whole-gut transit time and measure~     pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate~     release and extended release capsules.~   "
111505|NCT01596764|"~     The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in~     preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to~     measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral~     administration of methylnaltrexone and naloxone.~   "
111506|NCT01596751|"~     The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397~     when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2~     portion of the study is to find out what effects, good and/or bad, these drugs have on~     patients and their metastatic breast cancer.~   "
111760|NCT01593449|"~     The present study aims to initially test a community dog walking intervention that addresses~     individual, interpersonal and community factors associated with dog walking. The study will~     be conducted in two cities, Worcester and Lowell, as a collaboration between investigators~     from UMass Medical School and UMass-Lowell.~   "
111507|NCT01596738|"~     The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a~     standard management strategy for patients with acute coronary syndrome. On this background,~     an increasing percentage of patients presenting for surgical coronary revascularization is~     the subject to irreversible platelet inhibition.~      Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for~     aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB~     activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological~     inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and~     fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin~     formation and inhibits fibrinolysis.~      Many studies and meta-analyses have shown a reduction in postoperative bleeding and~     transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery.~     Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few~     studies specify the time between the last clopidogrel ingestion and surgery.Several studies~     were keen on the blood loss and allogeneic transfusion in patients who received their last~     clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the~     secession of aprotinin and the increasing proportion of patients with persistence on~     clopidogrel until their surgery, evolutional work is expected, especially in the eastern~     population.~      The purpose of this study is to assess the effect of tranexamic acid in patients with~     clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis~     is that tranexamic acid would reduce bleeding and transfusion requirements in this specific~     population of patients.~   "
111508|NCT01596725|"~     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian~     flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down~     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test~     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment~     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts~     of the study.~   "
111509|NCT01596712|"~     This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and~     immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the~     eligibility of Japanese patients in subsequent clinical studies.~   "
111510|NCT01596699|"~     The purpose of this study is to find out what effects, good and/or bad, the addition of~     clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning~     treatment has. The study will also look at what causes some people to have high drug levels~     of these medications in their body compared to other people that may have low drug levels~     even if they all receive the same dose of medication.~   "
111511|NCT01596686|"~     The investigators intend to study the impact of two different preparation regimens for~     colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient~     tolerability.~   "
111512|NCT01596673|"~     The purpose of this study is to assess the relative abuse potential of the hydrocodone~     bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.~   "
111513|NCT01596660|"~     The ambulatory management after laparoscopic hysterectomy is a reality in our service, where~     90% of hysterectomies are laparoscopically done and 80% of these are managed on an~     ambulatory basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79)~     range from 5 to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours)~      So far the immediate analgesic management has been made systemically, and the satisfaction~     reported by patients was high, even though some patients require longer stay in recovery and~     need higher doses of analgesics before their discharge criteria, allowing an optimal~     ambulatory management.~      There are several treatment options that theoretically could be used but the results have~     been variable and have failed to demonstrate the expected benefit.~      The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the~     plane between the internal oblique and transverse abdominal, looking to infiltrate the~     spinal nerves at this level, so the innervation to the skin, muscles and the parietal~     peritoneum will be interrupted. The TAP Block was first described in 2001 , based on anatomy~     marks techniques of the peripheral nerves and was developed and evaluated later by McDonnell~     et al.~   "
111514|NCT01596647|"~     This is a multi-center, open-label, phase I study to assess the effects of dovitinib~     (TKI258) on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and~     midazolam in patients with advanced solid tumors, excluding breast cancer. The aim of this~     study is to evaluate the potential effect of dovitinib (TKI258) on the metabolism of the~     probe drugs caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2,~     CYP2C9, CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the~     single-dose pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the~     individual probe drug co-administered with and without multiple dose of dovitinib (TKI258)~     500 mg under a 5 days on / 2 days off dose schedule. The study foresees two treatment~     phases: DDI (drug-drug interaction) followed by post-DDI. During the DDI phase patients~     receive treatment with the probe drug cocktail and dovitinib (TKI258). During the post-DDI~     phase patients may continue to receive treatment with dovitinib (TKI258) until disease~     progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from~     the study treatment for any other reason.~   "
111515|NCT01596634|"~     The purpose of this research study is to determine if using a lactoferrin supplement will~     improve taste perception. Lactoferrin is a type of protein that is naturally produced in the~     body and is commonly found in saliva.~   "
111516|NCT01596621|"~     The primary objective of the study is to determine the overall response rate (ORR), which~     includes complete response (CR) and partial response (PR), to bendamustine treatment in~     patients with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a~     rituximab-containing therapy.~   "
111518|NCT01596595|"~     Post-approval studies of implanted leads provide an opportunity to observe and assess~     patient outcomes and technology performance in a real-world setting. The goal of the study~     is to evaluate, document and report on the appropriate clinical performance, long-term~     reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™~     Lead and the pulse generator 4-SITE Header.~   "
111771|NCT01593306|"~     The purpose of this study is to check whether addition of paclitaxel to cisplatin and~     radiation therapy will improve the outcome in locally advanced carcinoma cervix.~   "
111519|NCT01596582|"~     Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal~     cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel~     computer-based decision aid facilitates several components of SDM from both the patient and~     provider perspective, there is a reluctance among providers to acquiesce to patient~     preferences for a particular screening strategy when its differs from their own. The overall~     objective of this study is to assess whether risk stratification for advanced colorectal~     neoplasia influences clinical decision-making related to screening test selection and~     adherence within a SDM framework. Eligible subjects will be randomized to either an~     experimental arm, in which they will be asked to complete a 6-item risk assessment~     questionnaire known as the Advanced Colorectal Neoplasia Index [ACNI] before reviewing a~     web-based decision aid, or a control arm, in which they will only review the decision aid.~     Both interventions will take place just before a prearranged office visit with their~     provider. The primary outcome will be screening test ordered; secondary outcomes will~     include test completion rates, value concordance, patient satisfaction with decision-making~     process and provider satisfaction. Outcomes will be evaluated using computerized tracking~     systems or validated instruments.~   "
111520|NCT01596569|"~     This study investigates the efficacy of a novel neurorehabilitation program combining~     noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive~     therapy, on cognitive function and quality of life in individuals with blast-induced~     traumatic brain injury (bTBI).~   "
111521|NCT01596556|"~     To the best of our knowledge, a possible relation between smoking and heat injuries or heat~     intolerance was never scientifically examined, although such a relation is logical according~     to the observations that smoking has a thermogenic effect, decreases physical fitness and~     affects the body's heat dissipation.16 healthy young male volunteers will participate in the~     study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will~     perform VO2 test and heat tolerance test (HTT) in different conditions.~   "
111522|NCT01596543|"~     The purpose of the present study is to evaluate the effect of partial and complete sleep~     deprivation on exercise heat tolerance. Twelve healthy young male volunteers will~     participate in the study. They will arrive to our lab four times, in each visit the will~     undergo VO2 test and Heat Tolerance Test (HTT) after sleeping different amount of hours.~   "
111523|NCT01596530|"~     To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours~   "
111524|NCT01596517|"~     The purpose of this study is to investigate the efficacy and effectiveness of peginterferon~     alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.~   "
111525|NCT01596504|"~     Primary Objective:~      - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily~     (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma~     glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after~     a standardized breakfast at the end of a 8-week treatment period in participants with type 2~     diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).~      Secondary Objectives:~        -  To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8~          mg QD after an 8-week treatment period in participants with T2DM not adequately~          controlled with insulin glargine (± metformin) on:~             -  Post-prandial C-peptide, glucagon and appetite perceptions after a standardized~               breakfast,~             -  Appetite perceptions after standardized dinner,~             -  Gastric emptying after a standardized labelled test meal,~             -  Fasting plasma glucose, 24-hour plasma glucose profile,~             -  Glycosylated hemoglobin (HbA1c),~             -  Insulin glargine dose,~             -  7-point self monitored plasma glucose (SMPG),~             -  Body weight and waist circumference,~             -  24-hour heart rate and blood pressure,~        -  To assess lixisenatide and liraglutide safety and tolerability as add on treatment to~          insulin glargine (± metformin).~   "
111526|NCT01596491|"~     The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use~     of capsaicin on skin.~      The investigators first experiences with capsaicin in patients with peripheral nerve injury~     showed changes in the sensibility, which achieved its maximal extent after four weeks and~     was regressive, but not completely abolished 1,5 months after application.~      In this study the investigators hope to specify, how long and in which way exactly this~     changes in sensibility appear.~   "
111527|NCT01596478|"~     The efficacy of psychosocial treatments for PG, including cognitive-behaviour therapy (CBT)~     and motivational interviewing (MI) approaches, has been supported in a handful of clinical~     trials. Indeed, there is more evidence supporting these two approaches than for any other~     psychosocial treatment for problem gambling. However, while efficacy studies have been~     conducted, few studies have examined the effectiveness of behavioural treatment in~     community-based gambling treatment settings. That is to say, the investigators have a good~     idea of what works in a laboratory setting (i.e., university research settings), but the~     investigators have no research assessing the transfer of evidence-based treatments for~     problem gambling to community care. Efficacy studies provide substantially less information~     about the actual utility of treatments than do effectiveness trials because the way in which~     treatment is actually provided in the field (with flexibility in terms of time-frame and~     technique and the tendency to address co-occurring problems) is different from the much more~     single-focused (on gambling) way it is conducted in laboratory settings. The proposed study~     is designed to address this significant gap in the research literature. The investigators~     propose to conduct a treatment effectiveness trial examining a combined cognitive~     motivational behavior therapy (CMBT) delivered by community-based problem gambling treatment~     providers, compared with treatment as usual (TAU).~   "
111528|NCT01596465|"~     Our objective was to test two educational interventions for teaching cardiac auscultation:~     self-directed learning using portable audio files versus a single, massed multimedia lecture~     intervention similar to current best practice, to determine which would most effectively~     increase recognition of common cardiac sounds by physicians. The investigators hypothesized~     that doctors learning on their own time could better improve their skills.~   "
111529|NCT01596452|"~     Modern anti-cancer treatments are focused on development of molecular based therapies i.e.~     specific treatments targeted against underlying biological processes. There is still much to~     learn about the biology of cancer, especially in tumours such as colorectal and lung cancer~     where it is likely multiple heterogenous signaling pathways are responsible for progression~     of disease. This project aims to evaluate circulating tumour cells (CTCs) as a surrogate~     biomarker for tumour characteristics and to determine how they may used to identify new~     targets for therapeutic agents. Their use could be applied to diagnosis of cancer,~     prediction of response to therapies and prognosis, ultimately across a broad range of tumour~     types. Currently the only way to investigate molecular features of a cancer is through~     procurement of an invasive tumour biopsy that is often difficult to obtain, often results in~     insufficient material and is unpleasant for the patient. A blood-based test would provide a~     much more practical and patient friendly alternative. The enumeration and molecular~     characterisation of CTCs has the novel potential of being a virtual biopsy of the tumour~     and offers the opportunity for immediate therapeutic decisions (eg. if the tumour develops a~     therapy resistant genotype while on treatment). CTCs have been known to circulate in~     bloodstream of cancer patients for many years and are known to lead to cancer metastases.~     They have been very difficult to detect, up until recently, due to the complexity of the~     metastatic process and detecting relatively small numbers of CTCs amongst billions of red~     and white blood cells. However, technology has moved on dramatically in the last few years.~     The FDA approved CellSearch platform (Veridex, NJ) can isolate and enumerate CTCs based on~     the immunomagnetic capture of EpCAM (epithelial cell adhesion molecule) positive cells.~     Several studies have recently demonstrated the value of CTC enumeration in reflecting~     prognosis and predicting early response to systemic chemotherapy. For example, in a study~     comprising 456 patients with metastatic colorectal cancer starting a new line of therapy,~     patients with =3 CTCs per 7.5 ml blood at baseline had shorter progression free survival~     (PFS) and overall survival (OS) compared to those patients with < 3CTCs at baseline (PFS 4.5~     versus 7.9 months P=0.0001; OS 8.5 versus 19.1 months P=0.0000 respectively). Overall~     survival for patients converting to or maintaining CTCs =3 within a few weeks of commencing~     systemic therapy remained worse than for those patients maintaining CTC counts < 3 per 7.5ml~     blood. Similar results have been reported in patients with breast and hormone refractory~     prostate cancer (HRPC). These studies have led to FDA approval of the CellSearch system as~     an adjunct to monitoring patients with these 3 tumour types. The CellSearch platform,~     however, does not allow for the downstream DNA analysis of captured cells and the~     ferroparticle-coated CTCs are non-viable. Furthermore, this platform is a multi-machine,~     multi-kit system that is laborious (typical 3-7 days turnover time), expensive (USD 650),~     and subject to operator variance. In this protocol, the investigators propose for the first~     time, an automated, fully quantitative system for isolation and enrichment of CTCs. The key~     differentiating feature of our novel CMOS system is the electrochemical identification and~     counting of tumour cells using a high density electrode array with associated electronics~     for addressing the electrodes. This leads to a standardized assay for tumour cells with a~     shorter turnover time and without the need of a skilled operator. This system also holds the~     potential for allowing the molecular characterization of CTCs. This study aims to enumerate~     CTCs using a novel CMOS technology in patients with metastatic cancer who are scheduled to~     receive palliative chemotherapy, and to correlate CTC number with clinical outcome. In Part~     I of the study, the investigators will recruit 10 patients with metastatic NSCLC and 10~     patients with metastatic CRC in order to assess the feasibility of CTC enumeration in~     patients. In particular, the investigators aim to establish whether CTCs are detectable~     using the novel CMOS technology in patients with metastatic cancer. In Part II of the study,~     the investigators will recruit 21 patients with metastatic NSCLC and 89 patients with~     metastatic CRC in order to compare CTC counts as determined by the CMOS technology with CTC~     counts as determined by the CellSearch platform. Blood samples will be collected at a single~     time point prior to the start of palliative chemotherapy. CTC numbers will be correlated~     with clinical outcome in all evaluable patients.~      The investigators hypothesize that CTC enumeration by a novel CMOS technology is~     non-inferior to CTC enumeration by the CellSearch platform in patients with advanced solid~     malignancies.~   "
111541|NCT01596296|"~     The purpose of this study is to assess the effectiveness and safety of transcervical foley~     catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening~     and labor induction in term parous women with unfavorable cervix.~   "
111530|NCT01596439|"~     The primary objective of this prospective pilot study is to examine the variation of~     cognitive function at various time-points in stage I-III breast cancer patients who have~     undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal~     therapy) and compare this to a group of healthy controls to evaluate if there is a~     difference. All randomized patients and their respective controls would be required to~     complete the computerized neuropsychological assessment CANTAB at certain time-points.These~     patients and controls would also be given on the same day as CANTAB testing, a set of~     questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or~     menopausal symptoms which may also have an effect on cognition. Subjective assessment of~     cognitive function will rely on self-reporting by study participants using a validated~     questionnaire.The potential risks to subjects are minimal, as this is a study without any~     intervention regarding the medical management of patients. By participating in this study,~     subjects will be helping in the aim of determining if there is cognitive impairment~     post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes~     with time. This will consequentially play an important role with regard to patient~     knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment,~     further studies can be carried out to determine the exact pathophysiology behind this~     phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in~     patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open~     the avenue for research in preventing or alleviating this phenomenon. This is crucial in~     improving patients' quality of life, social and occupational performance.~      The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy~     and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive~     impairment.~   "
111531|NCT01596426|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5~     years.~   "
111532|NCT01596413|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12~     years.~   "
111533|NCT01596400|"~     The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17~     years.~   "
111534|NCT01596387|"~     The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model~     to administer propofol in obese patients.~      Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing~     weight and that mathematical models to administer drugs in obese patients can be developed~     to accurately predict dose schemes in this population.~   "
111535|NCT01596374|"~     Alterations involving the ROS (v-ros UR2 sarcoma virus oncogene homolog 1) gene such as~     mutations, overexpression and gene rearrangements has been implicated in carcinogenesis and~     has been demonstrated to be a relevant target for ALK inhibitors. While emerging reports~     have demonstrated the role of ROS rearrangement in non-small cell lung cancer and~     cholangiocarcinoma, the functional significance of ROS dysregulation in solid tumors remain~     largely unstudied. The investigators aims are: (1) To characterize the frequency of ROS gene~     fusion, ROS protein overexpression and ROS gene mutations in cell lines and tumors from~     patients with hepatocellular carcinoma, colorectal, gastric, breast, ovarian,~     cholangiocarcinoma and non-small cell lung cancer, (2) To identify novel ROS gene variants~     in human solid tumors harboring ROS aberrations using next generation sequencing (NGS), (3)~     To determine the functional relevance of novel ROS gene variants identified with NGS, (4) To~     characterize the sensitivity of cells with functionally relevant ROS aberrations using ROS~     tyrosine kinase inhibitors. ROS fusions and protein overexpression will be screened in a~     panel of cell lines and primary tumors using Fluorescence In-situ Hybridization and~     immunohistochemistry respectively. Targeted next-generation sequencing will be applied to~     identify ROS variants in matching cancer types demonstrating high levels of gene fusion and~     protein overexpression. Functional characterization of novel ROS variants will be performed~     by silencing (shRNA) and overexpressing candidate cell lines with the respective ROS~     mutations/fusions, and evaluating their effects on biological functions including cell~     proliferation, migration, invasion and apoptosis, as well as sensitivity against ROS/ALK~     inhibitors. The investigators anticipate findings from this study will improve the~     investigators understanding of aberrant ROS signaling in an expanded group of cancer types,~     and potentially identifying a larger group of cancer patients that will benefit from ROS~     targeted therapy.~      Further insight of the role of ROS receptor tyrosine kinase will confirm it as a therapeutic~     target in human solid tumors and hence expand the indication of crizotinib and other dual~     ALK/ ROS inhibitors. Furthermore, given the rarity of ROS fusion receptor tyrosine kinase in~     reported cancers, defining the epidemiology of ROS aberrations in other unreported cancers~     harboring ROS pathway activation is essential to properly design future clinical trials of~     ROS inhibitors. The validation of ROS receptor tyrosine kinase will also provide a new~     therapeutic target in the treatment of cancer and expand the role of novel targeted agents.~     Findings from this study will further the investigators knowledge on the oncogenic functions~     of the ROS and the application of ROS inhibitors in an extended group of solid tumors.~   "
111536|NCT01596361|"~     Interethnic variability in chemotherapy response is becoming increasingly evident, making~     approaches for customizing chemotherapy treatment to different ethnic populations desirable.~     At the same time, significant genetic variation has also been observed between ethnic~     groups, including many germline and somatic pharmacogenetic variants involved in~     chemotherapy pharmacology. Recently, based on meta-analyses of studies on germline~     pharmacogenetic variant frequencies and clinical trials, the investigators found that~     chemotherapy outcomes between Asians and Caucasians colorectal cancer (CRC) patients could~     potentially be inferred from the frequencies of variants between the ethnic groups and their~     respective biological functions. In this study, the investigators seek to further clarify~     the validity of using pharmacogenetic variants to customize chemotherapy between ethnicities~     through the following specific aims: (1) To verify the differences observed in the frequency~     of germline pharmacogenetic variants related to chemotherapy between Asian and Caucasian CRC~     patients, (2) To test whether variations in the frequency of somatic pharmacogenetic gene~     mutations between Asian and Caucasian CRC patients could be used to infer differences in~     clinical outcomes between the two ethnicities. (3) (4) For Aim 1, DNA samples from~     approximately 1000 Asian and Caucasian CRC patients each will be analyzed for the frequency~     of a panel of germline pharmacogenetic variants identified in our meta-analyses using~     high-throughput methodology. For Aim 2, meta-analyses will be performed on pharmacogenetic~     studies and clinical trials to establish the relative frequencies of somatic variants and~     clinical outcomes in Asian and Caucasian CRC patients. These frequencies will be verified on~     the same series of DNA samples used in Aim 1. The clinical outcomes inferred from the~     frequency differences and biological functions will then be compared to those summarized~     from clinical trials. This data could provide a basis for developing a rational approach to~     customizing chemotherapy in non-Caucasian populations and improve assessment of drug~     feasibility in different ethnic populations.If validated, this working hypothesis would be~     of high clinical interest, giving the opportunity to use this as a DNA prognosis biomarker~     in CRC.~      Pharmacogenetic frequencies could be a potentially useful approach for predicting likely~     chemotherapy outcomes in non-Caucasian populations~   "
111537|NCT01596348|"~     The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.~   "
111538|NCT01596335|"~     The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison~     with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with~     Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The~     pharmacokinetics of TA-650 is also examined.~   "
111539|NCT01596322|"~     Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.~   "
111540|NCT01596309|"~     Obesity prevalence in elderly populations has increased in the last years, and the reduction~     of overweight and obesity is a priority target in populations of all age ranges worldwide.~     Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic~     functions may be compromised, and therefore there is a risk of developing comorbidities such~     as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context,~     plant extracts are a good source of antioxidant compounds. Among these compounds,~     polyphenols have been shown to have an important antioxidant effect. Scientific evidence~     based on epidemiological studies suggest that flavonoids from the diet play an important~     role on the prevention of cardiovascular disease. Cocoa and related products are an~     important source of flavonoids, providing even more than tea or wine. Generally, benefits~     associated to cocoa consumption are related to the ability for improving lipid profile and~     insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial~     dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly~     due to the capacity of the polyphenols contained to modify cellular transcription, and the~     secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages~     and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of~     cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body~     weight and to improve cardiovascular risk factors compared to the same diet with standard~     prepared meals.~   "
111542|NCT01596283|"~     The purpose of this study is to help us learn what is the best amount of fluid to administer~     to patients during liver surgery. Patients will receive either an amount for this surgery~     based on weight, blood pressure, heart rate and urine output or an amount guided by a~     computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The~     FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on~     real time information like blood pressure, pulse and the ability of the heart and blood~     vessels to maintain normal vital signs.~   "
111543|NCT01596270|"~     Primary Objective:~      - To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a~     day in patients with solid tumors or lymphoma.~      Secondary Objectives:~        -  To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or~          twice a day in patients with solid tumors or lymphoma.~        -  To evaluate the effect of food on blood levels of SAR245409 after administration of~          SAR245409 tablets in patients with solid tumors or lymphoma.~        -  To evaluate the effect of SAR245409 on the body after administration of SAR245409~          tablets once or twice a day in patients with solid tumors or lymphoma.~        -  To obtain information on how SAR245409 administered once or twice a day to patients~          with solid tumors or lymphoma affect disease symptoms and study treatment side effects~          as reported by the patients on a questionnaire.~        -  To explore the antitumor activity of SAR245409 tablets administered once or twice a day~          to patients with solid tumors or lymphoma.~   "
111544|NCT01596257|"~     The purpose of this study is to find out if getting a blood stem cell transplant with donor~     stem cells given over several days is better than getting a blood stem cell transplant with~     donor stem cells given over 1 day. We want to find out which procedure over will result in~     improved recovery of blood and immune function after transplant. When donor stem cells are~     given over various days in mice, the blood and immune system recovery is quicker.~   "
111545|NCT01596244|"~     The purpose of the study is to provide participants in economically depressed areas of~     Jordan essential knowledge, practical skills, and intimate support groups—called~     microclinics—for managing their diabetes. Microclinics consist of 2-8 individuals from~     pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that~     voluntarily participate in ongoing education and medical monitoring from local health care~     professionals, learning and practicing diabetes management strategies, sharing much-needed~     medical supplies, and exchanging social support in the form of regular micro-clinic~     meetings.~   "
111546|NCT01596231|"~     This is a study designed to test whether a single administration of kudzu extract (2 mg)~     will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking~     session when given as pretreatment 2 ½ hours before the drinking session.~   "
111547|NCT01596218|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved brentuximab vedotin for the treatment of GVHD.~      Currently, corticosteroids are the standard/first line of treatment for people with GVHD.~     However, some patients do not achieve a good response with steroids and other experience~     flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a~     weakening of the immune system. For this reason, there have been increased attempts by~     researchers to find other options for the treatment of Graft vs. Host Disease.~      Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of~     cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of~     protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target~     CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD,~     but results from other research studies show that it could help slow the growth of your~     disease.~      In this research study, we are trying to determine the safest dose of brentuximab vedotin~     that can be given to patients with GVHD.~   "
111548|NCT01596205|"~     Previous studies about cognitive intervention targeting older adults revealed that cognitive~     training had effects on the improvement of cognitive function.However, researches are rare~     that investigated direct changes of brain structures after cognitive training.~      The advanced scientific technique allowed us to develop service robots designed to assist~     human work, which can be important with an increase in the aging population and high costs~     of elderly care. In this regard, the investigators considered robots for elderly's cognitive~     training and developed 17 cognitive programs in collaboration with Center for Intelligent~     Robotics at Korea Institute of Science and Technology.~      The purposes of this study were to demonstrate the effects of the investigators newly~     developed robot assisted group cognitive training programs on the brain in older adults and~     to identify whether they can help to improve cognitive function or mood in the elderly~     compared to the conventional cognitive training or control group that were not involved in~     any cognitive training.~   "
111549|NCT01596192|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-[fluorine-18]~     fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that~     allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG~     uptake is caused by increased local metabolic activity. In this study, we aim to evaluate~     and characterize the correlation between CT-PET findings in patients suspected to have acute~     GVHD, and the disease course.~   "
111550|NCT01596179|"~     The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the~     best way to provide breast cancer patients with information through a computer connected to~     the internet. The study will determine if giving information during treatment may help~     patients cope better with their treatment. The hypothesis is that participants assigned to~     receive Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to~     treatment regimens and have improved symptom management than women who have access to the~     education portal only.~   "
111564|NCT01595997|"~     The overall purpose of this study is to support the development of a DLX105 topical~     formulation for the indication mild to moderate psoriasis vulgaris.~   "
111805|NCT01592864|"~     A study to compare the efficacy of a test dentifrice against a control dentifrice in~     reducing dentinal hypersensitivity over an eight week treatment period.~   "
111551|NCT01596166|"~     Migraine headaches are a common problem for children. When treatment at home fails, children~     may benefit from intravenous treatment administered in a hospital setting like the Emergency~     Department. Most treatments used however have only been tested in adults and the best~     treatment strategy for children is not always clear. The combination of more than one~     medication is frequently prescribed in Canadian Emergency Departments. The purpose of this~     study is to investigate whether the combination of ketorolac (an anti-inflammatory pain~     medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches)~     is better than metoclopramide by itself.~   "
111552|NCT01596153|"~     The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx)~     versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or~     antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.~   "
111553|NCT01596140|"~     The goal of this clinical research study is to find the highest tolerable dose of~     vemurafenib that can be given in combination with either everolimus or temsirolimus. The~     safety of these drug combinations will also be studied.~      Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is~     involved in cancer cell growth.~      Temsirolimus and everolimus are designed to block the growth of cancer cells, which may~     cause cancer cells to die.~   "
111554|NCT01596127|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     rituximab given by spinal tap in patients with lymphoid malignancies involving the central~     nervous system.~      A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is~     collected by inserting a needle into the lower back. The affected area is numbed with local~     anesthetic during the procedure. It will also be used to give chemotherapy in this study.~      Rituximab is designed to bind to a protein, called CD20, that is on the surface of the~     leukemia cells. This may cause the leukemia cells to die.~   "
111555|NCT01596114|"~     The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of~     molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine~     Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular~     response (MMR) or better after stopping TKI therapy.~      Secondary goals include:~        -  Identification of clinical and biological factors affecting the persistence of complete~          molecular remission after stopping TKI (e.g. level of Complete molecular remission~          (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)~        -  Evaluation of quality of life (QoL) in patients stopping TKI~        -  Evaluation of medico-economic impact of stopping TKI~        -  Estimating the number of patients in CMR who are eligible for stopping TKI therapy by~          setting up a screening log~        -  Time to recovery of CMR There will be no randomised comparison. Based on the experience~          of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month~          molecular-relapse-free survival probability of at least 40%. An interim analysis will~          be performed after a pilot phase where 200 patients have been observed for at least six~          months. Formally, it is planned to test the null hypothesis H0: Six-month molecular~          relapse-free survival probability P ≤ 40% against the alternative hypothesis H1:~          Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML~          patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log~          reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed~          by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will~          be performed during 3 years: Associated scientific projects are performed. Recruitment~          period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500~   "
111556|NCT01596101|"~     Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children~     admitted to the burn intensive care unit.~   "
111557|NCT01596088|"~     The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in~     the treatment of accidental extravasation of anthracycline anti-cancer agents.~   "
111558|NCT01596075|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the~     incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from~     HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched~     unrelated transplants. More effective prevention and treatment strategies are needed.~      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in~     animal models of various inflammatory diseases including multiple sclerosis, inflammatory~     bowel disease and rheumatoid arthritis.~      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and~     immunosuppressive effects.~      As such, it may be effective for both prevention and treatment of acute GVHD after~     allogeneic stem cell transplantation.~   "
111559|NCT01596062|"~     The aims of this study are to extensively study the levels of CD25-Receptors saturation and~     expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to~     demonstrate that saturation and expression vary according to the dose of Simulect® given),~     and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the~     data with Neoral®.~      It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks~     post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in~     combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin~     inhibitor free immunosuppressant therapy.~   "
111560|NCT01596049|"~     This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical~     repair of unilateral inguinal hernia, which is becoming the new standard of care in open~     surgical repair of inguinal hernia.~      The study design is interventional, enrolling 300 patients above 18 years of age, admitted~     for elective repair in the surgical department of Rambam Medical Health Care Campus, an~     academic medical center.~      The study will assess several outcomes including post-surgical pain, recurrence, quality of~     life and post surgical complications (e.g. wound infection, the formation of hematoma or~     seroma, etc).~   "
111561|NCT01596036|"~     The purpose of this study is to test if an early appointment (within 10 days) when compared~     to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation~     orientation and subsequent enrollment into cardiac rehabilitation.~   "
111562|NCT01596023|"~     The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA~     clearance for use in patients with respiratory difficulty. The investigators believe that~     the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing~     added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very~     severe chronic obstructive lung disease (COPD) to assess their work of breathing while using~     the NIOV system as measured by esophageal and stomach pressures.~   "
111563|NCT01596010|"~     This trial is conducted in Europe. The aim of this trial is to investigate whether a~     reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of~     Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.~   "
111568|NCT01595945|"~     Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even~     after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is~     still unclear. Lower resting metabolic rates were also reported after gastric banding~     bariatric surgery but have not yet been investigated in subjects after gastric bypass. The~     purpose of this study is to investigate the consequences on resting metabolic rate in~     subjects with obesity after moderate caloric restriction or gastric bypass.~   "
111569|NCT01595932|"~     The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in~     pediatric patients with predominant gas-related symptoms.~   "
111570|NCT01595919|"~     The objective of the current study is to determine the effects of an ad libitum intake of 1%~     milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food~     intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize~     that 1% milk will reduce food intake and result in better post-meal glycemic response~     compared to the other beverages.~   "
111571|NCT01595906|"~     The use of infantry helmets under heavy heat stress conditions, during physical exertion,~     may hinder the body's ability to effectively dissipate heat from the head area, thereby~     damaging the soldier's function. Therefore head cooling may potentially enable a longer~     duration of activity until reaching fatigue. An improvement in function may also be~     possible.The purpose of this research is to determine the extent of the cognitive and~     physiological strain caused by wearing a helmet under exertional conditions while exposed to~     heavy heat stress and to evaluate the effect of a unique ventilation system connected to the~     helmet on strain reduction.~   "
111572|NCT01595893|"~     Polymorphic light eruption (PLE) is a common photodermatosis with a high prevalence of~     approximately 11 to 21% in the population. Similar to lupus erythematosus (LE), an~     UV-inducible systemic autoimmune disease, PLE has a female preponderance with a mean onset~     in the second to third decade of life. PLE lesions are very itchy and typically appear on~     sun-exposed body sites in spring or early summer. The quality of life in patients with PLE~     is often severely disturbed, as evidenced by high levels of anxiety and depression. For~     prophylaxis besides conventional sunscreens, photo(chemo)therapy is effective in many cases,~     when administered over several weeks for hardening in early spring before the first natural~     sun exposure takes place. However, because prolonged treatment with UVB and/or~     photochemotherapy is potentially carcinogenic, the search for pathogenic mechanisms and new~     treatment options in PLE is ongoing. The exact pathogenesis of PLE is currently unknown but~     findings suggest an autoimmune-type background with resistance to UV-induced immune~     suppression and simultaneous immune reactions against skin photo-neoantigens. The~     investigators have recently found that PLE patients had significantly reduced~     1,25-(OH)2-vitamin D3 serum levels (13-14ng/ml) compared to the normal population~     (>30ng/ml). In addition, the investigators were able to demonstrate in an intra-individual~     half-body trial that topical administration of an immunostimulatory 1,25-(OH)2-vitamin-D3~     analogue calcipotriol reduced PLE symptoms in an experimental study. In the proposed~     randomized double-blinded placebo-controlled trial the investigators attempt to study the~     effect of oral vitamin D3 supplementation (2 x 40.000 IE, given orally two weeks apart) on~     PLE symptoms.~   "
111573|NCT01595880|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations~     of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component~     administered alone in healthy male volunteers.~   "
111574|NCT01595867|"~     This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study~     designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine~     sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational~     opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to~     be selected during Part A of the study (Dose Selection Phase). Each subject participated in~     the study for up to (approximately) 16 weeks and was confined in the clinic for a total of~     up to 12 nights.~   "
111575|NCT01595854|"~     Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new~     pharmacodynamic methods~   "
111576|NCT01595841|"~     Dialysis patients presenting for angioplasty intervention for graft failure will be~     randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess~     the time from primary failure or angioplasty intervention to second or next angioplasty~     intervention or graft failure.~   "
111577|NCT01595828|"~     The purpose of this study is to examine in detail the acute and chronic effects of~     pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk~     for the premature development of atherosclerosis (CAPITAIN).~   "
111578|NCT01595815|"~     Artificial oocyte activation with strontium chloride or calcium ionophore improves~     fertilization, embryo quality, pregnancy and delivery rate in women who showed complete~     fertilization failure or low fertilization rates~   "
111579|NCT01595802|"~     The purpose of the study is to determine the sensitivity, specificity and predictive values~     of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison~     to Trans Cranial Doppler(TCD).~   "
111580|NCT01595789|"~     The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1~     (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints~     compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly~     diagnosed type 2 diabetes (T2D).~      It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD~     patients with T2D will improve beta-cell function, left ventricular ejection fraction~     (LVEF), heart rate variability and lower 24h blood pressure among other selected endpoints.~      The present study on CAD patients with newly diagnosed T2D will address these selected~     endpoints during an investigator initiated, randomized, double blind, crossover,~     placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.~   "
111581|NCT01595776|"~     Aim: to value the safety and efficacy of local intramuscular administration of~     immunoselected autologous endothelial progenitor cells in the treatment of critical limb~     ischemia in patients without revascularization options.~      Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto~     transplantation of endothelial progenitor cells.~      Secondary goal: to value the efficacy of local administration of autologous endothelial~     progenitor cells in the treatment of critical limb ischemia~   "
111582|NCT01595763|"~     To asses the cost-effectiveness of implementing different diagnostic strategies in patients~     with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in~     primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care.~     To describe the differential diagnosis and the strength of association between each outcome~     variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional,~     multicentric study.~   "
111583|NCT01595750|"~     REVASC is a randomized, double-blind, placebo-controlled study which will involve 150~     patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment~     period beginimg in the coming weeks, will last nine months. Patients included in the study~     will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75~     patients) in a randomized manner. The CIBERES, as promoter of this study is expected to~     release final results for the third quarter of 2013.~      Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz,~     Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La~     Paz, Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.~      Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been~     studied in an extensive clinical program involving over 12,000 patients with COPD. In these~     studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of~     exacerbations and improved lung function, especially in those patients with associated~     chronic bronchitis.~   "
111584|NCT01595737|"~     This study aims to examine the efficacy of levosimendan in terms of reducing postoperative~     mortality and severe morbidity in patients undergoing non-emergent surgery for coronary~     revascularisation with or without ischaemic mitral regurgitation and who may or may not~     require repair or replacement of the mitral valve and have a LVEF < 35%.~   "
111585|NCT01595724|"~     The study aims to collect data on the influence of a treatment with Visanne (Dienogest~     2mg/d) on the Endometriosis related quality of life. These data will be collected using a~     special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also~     be used to describe the basic disease status and demographic characteristics of patients~     searching treatment by a gynecologist because of their endometriosis. In addition, the study~     will give insight into the typical diagnostic measures the physicians in different countries~     are using in the field of endometriosis.~   "
111586|NCT01595711|"~     The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo,~     Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance~     of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the~     individual, with higher sensitivity and specificity than other available objective methods.~      The skin conductance response to a calibrated noxious stimulus varies among patients. It~     defines two types of people depending on its magnitude.~      The investigators assume that the importance of skin conductance response to a noxious~     stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.~   "
111587|NCT01595698|"~     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,~     affecting 1% of the population. The treatment of schizophrenia is basically done with~     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a~     form of treatment seems to be considered. Among the most recommended exercise for the~     general population, the investigators highlight the aerobic and resistance exercises.~     However, few studies have reported the positive effect of aerobic exercise in the~     pathogenesis of schizophrenia. In relation to resistance exercise, it is unknown if the~     effect in patients with the disease, especially when one considers the junction of the two~     types of exercises in the same training session (called concurrent training). However, it is~     known, through clinical studies and animal models, that exercise modifies the brain improves~     neuroplasticity, the mental condition of the individual frames and reverses~     neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of~     aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression,~     and clinical global improvement. The hypothesis is that the types of proposed training,~     aerobic training, resistance training and concurrent training can improve clinical symptoms~     of the disease, and improve the side effects caused by drugs. It is believed that the~     clinical changes are accompanied by increased serum IGF-1 by resistance training and aerobic~     training by BDNF.~   "
111588|NCT01595685|"~     The goal of chronic hepatitis B (CHB) treatment is complete and permanent eradication of~     hepatitis B virus (HBV) from patient's body, which is best represented by serum HBsAg loss~     accompanied by undetectable serum HBV DNA level.~      While the most recently approved nucleos(t)ide analogues (NA) have marked antiviral potency~     and can induce HBV DNA undetectability in the majority of patients through prolonged~     treatment, NA need to be given long term, almost indefinitely, in most cases because they~     suppress HBV DNA only during therapy. For example, even after HBeAg-loss by a potent NA,~     suppression of serum HBV DNA to undetectable level is sustained only in about 23%-37% at 24~     weeks off treatment. Thus, continuous therapy with NA until HBsAg clearance remains~     necessary in a majority of cases.~      The recent availability of commercial quantitative assays of serum hepatitis B surface~     antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and~     treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or~     entecavir therapy is slower and less pronounced compared to interferon treatment, despite a~     higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that~     the predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is~     more than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear~     advantage in reducing the treatment duration required to achieve HBsAg-loss.~      Interestingly, in a recent preliminary study, 24-weeks of treatment with telbivudine has~     induced HBsAg decline as comparable to pegylated interferon treatment. Although there has~     been no head-to-head trial comparing NAs in inducing HBsAg decline, previous studies~     consistently suggested that the decline of HBsAg is greater during telbivudine treatment~     compared with lamivudine or entecavir.~      Thus, in this clinical trial, the investigators will investigate whether telbivudine is more~     effective in inducing HBsAg decline compared with entecavir in HBeAg-positive CHB patients~     who have achieved undetectable serum HBV DNA by preceding entecavir treatment.~   "
111589|NCT01595672|"~     The purpose of this study is to determine the effect and safety of early high-volume~     continuous veno-venous hemofiltration for patients with severe acute pancreatitis.~   "
111590|NCT01595659|"~     Among the many risk factors that contribute to young drivers' crash involvement, two are~     critical: peer passenger presence, which is unique to young drivers, and the influence of~     alcohol, a universal risk for drivers but one against which young drivers are most~     susceptible. Clarification of how passenger presence interacts with alcohol consumption to~     increase risk is needed. The impact of experimentally manipulated passenger characteristics~     and alcohol quantity on risky driving is observed using driving simulation and a random~     assignment experimental design with a sample of 18-19 year old male and female drivers.~   "
111806|NCT01592851|"~     A study to compare the efficacy of a test dentifrice against a control dentifrice in~     reducing dentinal hypersensitivity over a two week treatment period.~   "
111591|NCT01595646|"~     The study will examine the effects of intranasally administered long-acting insulin detemir~     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment~     (aMCI). The rationale for these studies is derived from growing evidence that insulin~     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD~     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may~     have beneficial effects on brain function. Intranasal administration of insulin increases~     insulin signaling in the brain without raising peripheral levels and causing hypoglycemia.~     Insulin detemir is an insulin analogue that may have better action in brain than other~     insulin formulations because of its albumin binding properties. The investigators will test~     the therapeutic effects of intranasally-administered insulin detemir in a study in which~     participants will receive insulin detemir, regular insulin, or placebo over a four month~     period. The investigators will test the hypothesis that insulin and insulin detemir will~     both improve memory and daily functioning in persons with AD/aMCI compared with placebo, but~     that insulin detemir will have the greatest effect.~   "
111592|NCT01595633|"~     In Korea, the number of suboptimal responders to rescue combination therapy is also~     increasing. As a matter of fact, according to the investigations in Korea, HBV DNA~     undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for~     patients with lamivudine resistance was reported to be only 32.4%, which suggested that the~     appropriate another rescue therapy might be urgently required. However, there is no~     promising oral antiviral agents to control these patients in Asia-Pacific region, where~     tenofovir is not widely available. Tenofovir has a higher potent antiviral efficacy and a~     negligible drug resistance rate. The switch from adefovir to tenofovir in patients who have~     insufficient hepatitis B virus (HBV) suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to~     increased viral suppression or more HBeAg loss/seroconversion.~      Here, the investigators aimed to conduct a randomized study on evaluating the antiviral~     efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic~     hepatitis B patients who have suboptimal response to adefovir-based combination rescue~     therapy due to nucleoside analogues Resistance (SATIS study).~   "
111593|NCT01595620|"~     The purpose of this study is to test the effects of cannabinoids on pain response using a~     variety of human experimental pain models.~   "
111594|NCT01595607|"~     The study will investigate the effect of avocado consumption on markers of vascular health.~     Sixty participants will be enrolled in the 6-week study. A randomized parallel design will~     be utilized. Participants will either receive a typical American diet, or a modified typical~     American diet in which avocado is substituted for foods that contain moderate and high~     amounts of saturated fat, to allow the isoenergetic inclusion of avocado.~   "
111595|NCT01595594|"~     The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non~     surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals~     will be selected and divided in two groups. On the treatment stage, the control group (Group~     C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will~     be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will~     be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until~     accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters~     measured will be: plaque index, pocket depth, bleeding on probing, relative clinical~     insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and~     the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard~     technique. The investigators expect to find identical or better results for the test group.~   "
111596|NCT01595581|"~     This study is being done to test whether taking testosterone can prevent loss of muscle mass~     and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is~     the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential~     for the development of male reproductive tissues and promotes increased muscle, bone mass,~     and the growth of body hair.~      The investigators hope to learn whether testosterone given before and after ACL~     reconstructive surgery will increase muscle mass and strength and potentially improve~     recovery time following surgery.~   "
111597|NCT01595568|"~     In adolescents, mental health problems are frequently associated with substance misuse, even~     considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to~     complicate the patient's treatment and prognosis by increasing, among others, substance use~     problems, reckless behaviours, relationships and school problems and suicidal thoughts. It~     is therefore critical to invest time and effort into developing an efficient approach to~     prevent and reduce substance use problems and offer these children a more global and optimal~     treatment.~      A brief personality-targeted intervention was developed with students of Canadian and~     English high schools based on four personality factors known to be implicated in the~     vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative~     Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).~      By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural~     intervention proved to reduce binge drinking, quantity and frequency of use and substance~     use problems (Conrod et al., 2006,2011).~      The purpose of this study is to assess the impact of this intervention if combined to a~     regular treatment in a youth psychiatric population.~      60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be~     screened for personality risk with self-report assessments including the Substance Use Risk~     Profile Scale. Participants will be randomly assigned to a personality matched~     cognitive-behavioural intervention or a no-intervention control.~      The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary~     measures include mental health symptoms.~   "
111598|NCT01595555|"~     This research will examine whether an Internet-based mindfulness program for stress~     management produced positive outcomes for participants and is technologically feasible~   "
111599|NCT01595542|"~     The study will evaluate a health services intervention to increase uptake of adolescent~     vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five~     school health centers by improving the consent process for parents.~   "
111758|NCT01593475|"~     This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed~     by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer~     patients with locally advanced disease and the purpose of this trial is to evaluate the~     efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable~     pancreatic carcinoma.~   "
111600|NCT01595529|"~     To determine if halting antimicrobial therapy in subjects who have exhibited clinical~     improvement 5 days after starting antibiotic therapy (short course therapy) have the same~     failure rate, defined as symptomatic Urinary Tract Infection (UTI) through Test of Cure~     (TOC) on Day 11-14, as subjects who continue to take antibiotics for an additional 5 days~     (standard course therapy). To determine if short-course therapy compared to standard course~     therapy results in similar numbers of children with gastrointestinal colonization of~     antimicrobial resistant Escherichia coli (E. coli) and Klebsiella pneumonia (K. pneumoniae).~   "
111601|NCT01595516|"~     The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult~     humans with elevated blood pressure to a greater extent than either metoprolol or placebo.~     The investigators further hypothesize that the improvement in the capacity of the vascular~     endothelium to release t-PA with nebivolol is mediated, in part, by the compound's~     antioxidant properties.~   "
111602|NCT01595503|"~     Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses~     magnetic energy applied to the scalp to modulate activity in the underlying regions of the~     brain. In this study we will examine the efficacy of treating auditory hallucinations in~     schizophrenia with rTMS, comparing two methods to target stimulation to a language~     processing region of the brain. One method targets the stimulation site using scalp~     landmarks, while the other uses functional magnetic resonance imaging (fMRI) combined with a~     language task.~   "
111603|NCT01595490|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic~     stress symptoms, depression, and levels of aggression compared to a control group.~   "
111604|NCT01595477|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized children in Gaza will result in improvement of posttraumatic~     stress symptoms, depression, and decreased hopelessness compared to a control group.~   "
111605|NCT01595464|"~     The objective of this study is to determine whether participation in a mind-body skills~     program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress~     symptoms and depression, and will increase posttraumatic growth compared to a control group.~   "
111606|NCT01595451|"~     We are doing this study to investigate the effects of acupuncture on chronic low back pain.~     We are interested in learning about brain activity during pain. We plan to look at brain~     activity at the beginning and the end of the study, after 6 sessions of acupuncture~     treatment. You will be randomly assigned to one of two groups to receive either real or~     placebo acupuncture.~      Acupuncture has been used for many years to help relieve pain. However, it is not clear how~     acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system.~     Some studies indicate that acupuncture may relieve the low back pain. However, we need more~     research to see how well acupuncture works to relieve pain for people with this condition.~      In this study, we will measure your brain activity before and after you do exercises to make~     your back pain worse. We will also measure your brain activity while inflating a pressure~     cuff device on your lower leg. We will measure this brain activity using a research tool~     called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a~     magnet, and allows the study investigators to look at changes in blood flow to different~     parts of the brain when there are changes in brain activity.~   "
111607|NCT01595438|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to~     Doripenem for treating hospitalized patients with complicated urinary tract infections,~     including acute pyelonephritis~   "
111608|NCT01595425|"~     This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC~     capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of~     these two formulations in healthy male Japanese subjects.~   "
111609|NCT01595412|"~     Background:~      Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the~     western world. Surgery is the only definite treatment and is preferably performed minimally~     invasive. High-level prospective studies on treatment strategies for RP currently are~     lacking and, thus, no consensus exist regarding the optimal treatment for patients with RP.~     Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral~     rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection~     Rectopexy (LRR) remains the golden standard.~      Objective:~      To determine the optimal minimally invasive surgical treatment for patients with RP.~      Design:~      International, prospective, comparative double cohort study. The first cohort will consist~     of 120 European patients with a RP and will be treated with LVR. Centres in The Netherlands,~     Belgium and the UK are enlisted for participation. The second cohort will consist of 120~     American patients with a RP, treated with LRR. Several US centres are enlisted. Preoperative~     work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is~     set on two years. During FU, pre-operative imaging and questionnaires will be repeated.~      Primary & secondary outcomes:~      Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI).~     Secondary endpoints will be generic Quality-of-Life, functional results, morbidity,~     mortality, recurrences and cost-effectiveness.~      Time frame:~      Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24~     months. Therefore, total study duration will be 42-48 months.~   "
111610|NCT01595399|"~     The purpose of this study is to compare heart rate in infants who receive atropine as a part~     of their medication before intubation to those who do not.~      To be able to find out , we need to divided babies into 2 groups;~      group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline~     ( placebo group) + sedation + muscle relaxant~      Then we need to compare heart rate during intubation and duration of intubation between the~     2 groups.~   "
111611|NCT01595386|"~     This protocol is designed to offer insight into critical illness related corticosteroid~     insufficiency and steroid supplementation in neonates undergoing cardiac surgery with~     cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative~     period.~   "
111612|NCT01595373|"~     The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are~     healthy young men. End points are interstitial concentrations of glucose, lactate, and~     glycerol.~   "
111613|NCT01595360|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in~     healthy volunteers after tooth extraction.~   "
111614|NCT01595347|"~     Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly~     immobilized persons, increasing the burden of care to professionals in the health system, as~     well as pharmaceutical spending. There are studies of the effectiveness of various products~     in the prevention of the UPP, most made in hospitals and using fundamentally composed based~     on oily hyperbecome oxygenated acids (AGHO).~      There do not exist studies realized specifically with cream of olive oil.~      AIMS:~      Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized~     patients consisting in the application of cream of olive oil. Secondary: To evaluate the~     cost - efficiency of this new intervention opposite to AGHO's application.~      To value the degree of satisfaction of the patient and his keeper with regard to the use of~     cream of olive oil.~      METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population~     consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients~     immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive~     oil to the group of intervention and AGHO's administration to the group control. Follow-up~     for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and~     clinical data, presence of technical supports, information of the caragiver and~     questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's~     calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of~     Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model~     multivariant.~   "
111615|NCT01595334|"~     1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions~          during menstrual cycle at appropriate plasma levels'~        2. In early follicular phase,in the requisite range,LH is known to contribute to~          maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).~        3. If during this transition, appropriate level of LH can be maintained either through the~          use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or~          supplementation with exogenous LH, if found deficient, maturation process can be~          enhanced.~        4. Further maintenance of suitable combination of recombinant follicle stimulating hormone~          (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher~          probability of establishing clinical pregnancy.~   "
111616|NCT01595321|"~     The purpose of this study is to estimate safety of a whole cell vaccine with immune~     modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in~     pancreatic cancer patients after surgery.~   "
111617|NCT01595308|"~     How daily consumption of pomegranate juice affects the concentration, morphology or motility~     of sperm in healthy men.~   "
111618|NCT01595295|"~     This Patient Registry is set up to collect real-world experience in the management of~     patients with myelodysplastic syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or~     elderly patients with Acute myeloid leukemia (AML) ineligible for high dose chemotherapy,~     treated with hypomethylating agents in Austria. This registry will collect data in a~     retrospective as well as in a prospective manner at various sites in Austria. The aim is to~     gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical~     setting in patients with various comorbidities.~   "
111619|NCT01595282|"~     The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on~     immediate post-procedural pain scores in patients undergoing first trimester suction~     curettage with local anesthesia only.~      Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an~     approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately~     after the procedure.~      Secondary hypotheses include:~        -  Pain scores on the 21-point scale will also be significantly lower in the ketorolac~          group immediately after cervical dilation and 15 minutes post-procedure.~        -  Fewer patients in the ketorolac group will rate their pain as severe on a subjective~          pain rating scale.~        -  Patients in the ketorolac group will be more satisfied with their pain control.~        -  Side effects will be similar between groups.~   "
111620|NCT01595269|"~     This project addresses the following Null Hypotheses:~        1. There will be no difference will be found in the use of the search engine and the~          information accessed among the three education modes.~        2. There will be no difference in education mode's effect on metabolic control, self-care~          management practices, and medical resource utilization.~        3. There will be no difference in the economic impact on the health care system based on~          differing education modes.~   "
111621|NCT01595256|"~     The aims of this four-year study are to~        1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and~          lower legs)~        2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on~          muscle strength and fatigue.~        3. develop a clinical guidelines of home-based walking program for patients with~          colorectal cancer receiving active treatment and survivors in Taiwan.~        4. explore the relationships among the self-report fatigue intensity and metabolism.~   "
111622|NCT01595243|"~     The aims of this three-year study are to:~        1. From patients and family perspective to explore the needs for home care after receiving~          TACE, PEI, and RFA~        2. Develop a telephone follow-up and consultation program and examine its effect on~          self-efficacy, anxiety, depression and quality of life in liver cancer patients~          receiving non-surgical treatment.~   "
111623|NCT01595230|"~     The purpose of this study is to determine whether closure of all mesenteric defects with~     clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction-~     internal hernias~   "
111624|NCT01595217|"~     Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI~     sequence with MRCP versus MRCP only separately.~   "
111633|NCT01595100|"~     Childhood obesity is a major public health issue, and the identification of children who are~     at increased risk of health problems due to their obesity is a priority for modern health~     care. Abdominal fat is considered to be the most harmful in the body, and the development of~     reliable landmarks and procedures for the assessment of intra-abdominal visceral adipose~     tissue and total body fat in children will have a major impact on 1) the early~     identification of children at elevated health risk, 2) the proper prioritization of health~     care resources, and 3) the standardization of obesity surveillance procedures within and~     between countries.~   "
113665|NCT01568411|"~     This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)~     and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10~     mg tablet of TD- 1211 administered orally to fasted subjects.~   "
111625|NCT01595204|"~     Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic~     score to predict possibility of optimal cytoreduction in patients with ovarian / tubal /~     peritoneal advanced at the time of first surgery. The study consists of subjecting all~     patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs).~      Laparoscopy should be described and recorded in electronic form. After the procedure each~     patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI).~     The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The~     data collected and the video should be sent to the Center Coordinator, who will determine~     the adequacy of the procedure and the accuracy of the score enrollment is completed for each~     center. All eligible subjects will be considered by intention-to-treat population (ITT). For~     this phase of the study, it is not necessary know the outcome of the surgical patient (RT)~     or if it was then subjected to exploratory laparotomy or less.~   "
111626|NCT01595191|"~     Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy~     preterm infants. Whether this finding is related to music per-se or to music by Mozart is~     unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE~     similar to that of Mozart music.~   "
111627|NCT01595178|"~     Smoking and drinking are two of the three leading causes of preventable deaths in the United~     States today. Using both alcohol and tobacco significantly multiplies the risk of disease~     and death from myocardial infarction, COPD, and multiple cancers. Combined use of these~     substances is extremely common; people who drink are three times more likely than the~     general population to smoke, and tobacco dependent individuals are four times more likely~     than the general population to be alcohol-dependent.~      Research has shown that there is a high prevalence of unmet substance abuse treatment need~     among adult Emergency Department (ED) patients. The current project aims to conduct a pilot~     feasibility study with 50 adult ED patients to develop a brief counseling intervention that~     is feasible and acceptable to patients who are both smokers and at-risk drinkers to help~     them reduce these behaviors.~      The overarching aim of this line of research is to find the best treatment for ED patients~     who are combo smokers and at-risk drinkers. The study will focus on the development of an~     intervention that will be tested in a future larger scale randomized clinical trial.~   "
111628|NCT01595165|"~     Transversus abdominis plane (TAP) block has gained popularity for the control of~     postoperative pain in various surgeries. Three studies showed inconsistent result on pain~     control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these~     studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid~     incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP~     rarely extend above T8, the investigators undergo subcostal TAP block for this type of~     surgery. The investigators are going to investigate the effect of subcostal TAP on early~     postoperative pain after laparoscopic cholecystectomy.~   "
111629|NCT01595152|"~     Hypothesis:~      Objective 1: To advance the investigators understanding on the effect of solifenacin~     succinate (10 mg OD) vs. fesoterodine (8mg OD) on urinary urgency using a validated Urgency~     Severity and Impact Questionnaire (USIQ).~      Hypothesis 1.1: The severity of urgency symptoms as measured by USIQ will change differently~     in women with OAB following a 3 month treatment with solifenacin succinate (10 mg OD) vs.~     fesoterodine (8mg OD).~      Hypothesis 2.1: Condition-specific quality of life (QOL) as measured by USIQ will change~     differently in women with OAB following a 3 month treatment with solifenacin succinate (10~     mg OD) vs. fesoterodine (8mg OD).~      Objective 2: To advance the investigators understanding on the adverse events (AE's) of~     solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).~      Hypothesis 1.1: The severity and rate of AE's in women with OAB following a 3 month of~     treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD) will be different.~   "
111630|NCT01595139|"~     MicroRNAs are small molecules which have recently been discovered in cells. They are known~     to be responsible for the normal development of cells and when they are disrupted can~     contribute to the development of cancer. Many previous studies have been done evaluating the~     expression of microRNAs in normal tissues as well as in a wide variety of cancers.~      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients~     with cancer. This presents a novel opportunity to assess the utility of microRNAs in the~     blood as an early predictor of cancer as well as a marker of response to therapy. No~     previous studies have been performed evaluating microRNAs in archived tumor tissue and blood~     of patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility~     study to evaluate the presence of microRNAs in archived tumor tissue and the blood of~     patients with NF-1. If the investigators are able to identify circulating microRNAs in this~     population of pediatric patients, they will build upon this data in proposing a future~     study.~   "
111631|NCT01595126|"~     Biomarkers are small molecules that can be detected in the body fluids of patients; they~     often correlate with the presence of a cancer. MicroRNAs and proteins are small molecules~     which have recently been discovered in cells. They are known to be responsible for the~     normal development of cells and when they are disrupted can contribute to the development of~     cancer. Many previous studies have been done evaluating the expression of microRNAs and~     proteins in normal tissues as well as a wide variety of cancers.~      Recently, microRNAs and proteins from tumor cells have been detected circulating in the~     blood of patients with cancer. This presents a novel opportunity to use microRNAs and~     proteins in the blood as an early predictor of cancer as well as a marker of response to~     therapy. Previous work in our labs have identified miRNAs and proteins in the blood and~     cerebrospinal fluid (CSF) of pediatric patients with brain tumors.~      To determine a longitudinal evaluation of the presence of microRNAs and proteins in the~     blood, cerebrospinal fluid and urine of patients with central nervous system tumors from~     diagnosis through the course of their treatment. Though the duration of active treatment~     varies significantly based upon the diagnosis, patients will be followed for up to 24 months~     after enrollment onto the study).~   "
111632|NCT01595113|"~     The purpose of this study is to evaluate the safety of the previously conducted clinical~     trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial~     infarction. This is a follow-up observational study and targeting the subjects who~     participated in the previously conducted clinical trial.~   "
111658|NCT01594775|"~     effects of intranasal oxytocin and couple interaction on wound healing.~        -  Trial with medicinal product~   "
111634|NCT01595087|"~     This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety~     and biological efficacy of up to six dose levels of Osteodex of patients with metastatic~     castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing~     three known substances; dextran, alendronate and guanidine.~      The objective of the study is to define the maximum tolerable dose of Osteodex when given~     every third week. The following objectives will also be evaluated: overall survival, PSA~     response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and~     assessment of pharmacokinetic parameters.~   "
111635|NCT01595074|"~     This research trial studies biomarkers in predicting treatment response in samples from~     patients with early-stage non-small cell lung cancer previously treated with adjuvant~     chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~   "
111636|NCT01595061|"~     This phase II trial studies how well giving radiation therapy together with gemcitabine~     hydrochloride and cisplatin work in treating patients with locally advanced squamous cell~     carcinoma of the vulva. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving radiation therapy together with gemcitabine hydrochloride and~     cisplatin may kill more tumor cells.~   "
111637|NCT01595048|"~     This randomized phase II/III trial studies how well combination chemotherapy with or without~     rituximab works in treating younger patients with stage III-IV non-Hodgkin lymphoma or~     B-cell acute leukemia. Drugs used in chemotherapy work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Monoclonal antibody, such as rituximab, may block cancer growth in~     different ways by targeting certain cells. It is not yet known whether combination~     chemotherapy together with rituximab is more effective in treating patients with non-Hodgkin~     lymphoma or B-cell acute leukemia.~   "
111638|NCT01595035|"~     Evidence indicates that postoperative pain after day surgery is inadequately controlled.~     Patients have different experiences and knowledge about how to deal with pain, and the need~     for information and clarification may vary. The aim of this study is to enhance pain~     management by academic detailing (patients' current knowledge and motivations are the basis~     for information) and nurse coaching (frequent and individualized support). The study~     consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by~     a structured telephone interview; (2) development of an intervention to improve pain~     management; (3) implement and evaluate the intervention; (4) evaluate the incidence of~     chronic pain after day surgery. Even if patients are prescribed sufficient doses of~     analgesics, pain relief is dependent on patients' adherence with the analgesic regimen.~     Psychological factors, such as catastrophizing may also contribute to patients' experience~     of postoperative pain. Strategies that may be more effective than general information~     concerning surgery and pain management is academic detailing and nurse coaching, and will be~     used as frame for the intervention.~      Hypothesis:~      Over the seven days after surgery patients in the intervention group report;~        -  higher adherence with the analgesic regimen,~        -  have less pain intensity and pain interference with function and~        -  lower severity of side effects compared to the control group.~   "
111639|NCT01595022|"~     The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01~     and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and~     pain compared to a placebo T-frame intrauterine system.~   "
111640|NCT01595009|"~     To provide everolimus to patients with p-NET, GI or lung NETs before potential everolimus~     approval, the expanded access study CRAD001K24133 was designed to provide treatment until~     disease progression or unacceptable toxicity or until 30 May 2012, whichever occurs first.~     In this study, 60 patients with GI or lung NETs were enrolled in Germany and there are still~     approximately 40 patients benefiting from everolimus treatment.~      To provide the study medication to these patients beyond 30 May 2012, this open label~     extension will allow those patients who have been experiencing clinical benefit from~     everolimus treatment and who did not suffer from unacceptable toxicity to continue to~     receive treatment with the therapy until disease progression, unacceptable toxicity, or~     until study end on 31 May 2014, whichever comes first. Patients will be followed for safety~     and tolerability and for efficacy of everolimus.~   "
111641|NCT01594996|"~     The purpose of this retrospective observational study is to evaluate the characteristics of~     patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study~     will also investigate how the medication is used for these patients and if there are any~     differences in drug utilisation between the included countries. The study is observing~     patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months~     following the launch of the product in each country for the MDD indication. A drug~     utilisation questionnaire will be used to collect study data from patients' medical records.~   "
111642|NCT01594983|"~     This study is to determine a dose response signal for LCQ908 monotherapy and to assess the~     efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.~   "
111643|NCT01594970|"~     This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with~     elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular~     hypertension (OH).~   "
111644|NCT01594957|"~     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of~     hepatic impairment to healthy subjects.~   "
111645|NCT01594944|"~     The investigators will measure fetal orbital transverse and anterior-posterior diameter by~     2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other~     examinations during pregnancy. The investigators will examine 5-10 women in each gestational~     age in order to create a normal values curve throughout pregnancy.~   "
111659|NCT01594762|"~     The purpose of this study is to establish the clinical superiority and the safety of topical~     pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus~     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.~   "
111646|NCT01594931|"~     This is a double-blind, multicentre, randomised, parallel group, dose-finding study of the~     safety, tolerability and efficacy of a three day regimen of the combination of~     pyronaridine/artesunate in the ratio 3:1. The primary trial objective is to determine the~     clinical effective dose of orally administered pyronaridine/artesunate (3:1 weight/weight)~     ratio in the treatment of patients with acute uncomplicated P. falciparum malaria using the~     PCR-corrected adequate clinical and parasitological response (ACPR) at Day 28 as primary~     endpoint. Secondary trial objectives are to determine the safety of once daily dosing for~     three (3) days of pyronaridine+artesunate (3:1) combination in male and female patients with~     uncomplicated P. falciparum malaria and to explore possible ethnic differences in safety or~     efficacy in the two regions: South East Asia and Africa~   "
111647|NCT01594918|"~     The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone~     (CAMP) in combination at different dose levels and to determine the highest dose that does~     not cause bad side effects. The investigators want to find out what effects, good and/or~     bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.~   "
111648|NCT01594905|"~     Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective~     antiviral activity and prevent further development of antiviral resistance in hepatitis B e~     antigen(HBeAg)-positive or -negative Chronic Hepatitis B(CHB) patients who experienced~     multidrug resistance~      All subjects will orally take investigational drugs once daily for 48 weeks. All subjects~     will be assessed at baseline, Week 4, 12, 24, 36 and 48. Evaluations at each visit will~     include vital signs, physical examinations, laboratory tests and HBV DNA levels. They were~     also questioned about adverse events and concomitant medications. At baseline and every six~     months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be~     performed at baseline and 48 weeks.~   "
111649|NCT01594892|"~     It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly~     improves pain relief compared to historic data of conventionally fractionated radiotherapy.~     Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain~     reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale.~     60 patients will be included into this II trial.~   "
111650|NCT01594879|"~     A prospective multicenter trial has been started in Korea to investigate the treatment~     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone~     Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.~      The standard treatment for endometrial cancer is total hysterectomy and bilateral~     salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young~     patients who desire to preserve their potential for fertility may find this standard~     treatment difficult to accept. Therefore, the conservative treatment for these patients has~     remained a challenge. A number of studies have reported the effectiveness of hormonal~     therapy using systemic progestin in women clinically diagnosed with early endometrial~     adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. In~     addition, several recent studies reported the use of LNG-IUS to treat patients at a high~     risk of perioperative complications who cannot tolerate systemic progesterone because of its~     adverse effects. Nevertheless, there has been no prospective multicenter trial that~     investigated the effectiveness of treatment with systemic progesterone in combination with~     intrauterine progesterone in young women with endometrial cancer.~      Therefore, the investigators conducted a prospective trial of the treatment of the~     presumably early-stage grade 1 endometrial cancer in young women who desire to preserve~     fertility by using oral MPA in combination with LNG-IUS.~      Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is~     presumably confined to the endometrium, who desired to preserve fertility potential go~     through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently.~     Follow-up and treatment response assessment were implemented at a 3-month interval with~     office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage~     after removal of LNG-IUS.~      The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of~     the results between office endometrial aspiration biopsy and dilatation and curettage (D&C)~     procedure.~   "
111651|NCT01594866|"~     The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and~     30 mg in patients with major depressive disorder.~   "
111652|NCT01594853|"~     The purpose is to see how X-linked adrenoleukodystrophy (X-ALD) is associated with strength~     and sensation using MRI, in women with X-ALD. The investigators will also see whether~     exercise can improve these symptoms for women with X-ALD.~   "
111653|NCT01594840|"~     This randomized trial has two sets of diapers-- a normal one and one that has tips for how~     to talk to and engage your toddler. The investigators are hoping that the intervention~     improves language development.~   "
111654|NCT01594827|"~     The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection~     in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests~     that persistent infection with MRSA may result in an increased rate of decline in FEV1 and~     shortened survival. Currently there are no conclusive studies demonstrating an effective~     aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data~     demonstrating an effective and safe method of clearing persistent MRSA infection are needed.~      The purpose of this study is to evaluate the safety and efficacy of a 28-day course of~     vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in~     eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA~     infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250~     mg twice a day) or taste matched placebo and will be followed for 3 additional months. In~     addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or~     doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes.~     Forty patients with persistent respiratory tract MRSA infection will be enrolled in this~     trial.~   "
111655|NCT01594814|"~     Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating~     tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in~     relatively young age in patients without apparent structural heart disease or significant~     comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).~      The PPRA study is a prospective observational study developed to thoroughly analyze quality~     of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT~     or AVRT.~      Based on collected data the investigators will prepare a profile of patient who will benefit~     most from radiofrequency ablation and who should be scheduled in first place for the~     ablation in case of problems with accessibility to this service.~      What is more an analysis of medical and indirect costs of care will be performed.~   "
111656|NCT01594801|"~     This is the test protocol for the InsuPad device. The aim of the study is to show economical~     benefit when using the InsuPad device, by testing the effect of the InsuPad device on~     reducing injected insulin dose while keeping the same overall glycaemic control.~   "
111657|NCT01594788|"~     Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin~     (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure~     (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).~   "
111660|NCT01594749|"~     This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3~     (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of~     fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and~     corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV)~     associated with moderately emetogenic chemotherapy (MEC).~   "
111661|NCT01594736|"~     This prospective, randomized trial will compare the extent of covered stent strut segments~     by assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE~     PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).~   "
111662|NCT01594723|"~     The primary purpose of this study is to measure the response rate in participants with the~     myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET),~     or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an~     intolerance to, failure of primary response to, or have demonstrated disease progression~     while on ruxolitinib.~   "
111663|NCT01594710|"~     In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore,~     the investigators intend to the collect the blood sample, laboratory, anthropometric, and~     body composition parameters prospectively to examine the risk factors of metabolic syndrome.~     Furthermore, the investigators will collect the data of carotid IMT and branchial ankle~     pulse wave velocity to clarify the metabolic risk factors of atherosclerosis.~   "
111664|NCT01594697|"~     The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of~     pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome~     (PCOS) women became pregnant during metformin treatment and continued taking the drug during~     gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were~     performed at each trimester of gestation.~   "
111665|NCT01594684|"~     In stent restenosis in peripheral artery disease (superficial and popliteal artery) either~     treated with uncoated or paclitaxel coated balloons.~   "
111666|NCT01594671|"~     Total knee arthroplasty is often associated with excessive postoperative bleeding due to~     increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to~     determine the peri-operative bleeding comparing the application of topical and intravenous~     tranexamic acid with the habitual surgical haemostasis.~   "
111667|NCT01594658|"~     The venous ulcer due to venous insufficiency causes an important morbility to those people~     suffering from this condition. Most of therapies available under the obligatory health plan~     (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical~     handling using saline solutions, topical antibiotics and elastic dressings, implying an~     important intake from health resources due to its chronicity and the delay in ulcers~     healing, which usually takes periods ranging from 6 months to several years. therapeutical~     alternatives, which can guarantee optimal, fast and persistent in time healings, should be~     identified.~      The aim of this study is to determine the percentage of healing of active venous ulcers~     (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6)~     following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with~     chronic venous ulceration after six months from the intervention, compared with conservative~     medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of~     superficial venous reflux will diminish the time of ulcer healing compared with standard~     handling.~   "
111668|NCT01594645|"~     Presently spermatozoa for ICSI are selected based on morphology and motion, without~     determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although~     not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be~     an indicator of better spermatozoon quality and implantation potential, especially in severe~     OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to~     determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are~     injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using~     polarized light microscopy due to different bifriengance.~      In this study the investigators seek to determine, by a prospective RCT, if selecting only~     acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the~     entire IVF process.~   "
111669|NCT01594632|"~     A study to assess the contraceptive effectiveness of Sino-implant (II).~   "
111670|NCT01594619|"~     Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics~     of naloxegol.~   "
111671|NCT01594606|"~     The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI~     consists of a 10-week program in which adjudicated adolescents train shelter dogs and will~     be compared to a dog walking control group matched for educational content and dog contact~     time. The investigators expect that the AAI will result in improved empathy skills and that~     dog attachment will explain these findings. The investigators also explore the extent to~     which the AAI will improve internalizing and externalizing symptoms in these adolescents.~   "
111672|NCT01594593|"~     Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause~     of death in American men. Those diagnosed with localized prostate cancer encounter three~     sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3)~     the often life-altering side effects of treatment. In addition, patients who choose to~     undergo active surveillance which focuses on monitoring cancer in lieu of treatment,~     experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT)~     is an established psychosocial intervention that has been used extensively for mental health~     treatment and has shown benefits for various chronic conditions. ACT is a behavioral~     intervention that focuses on tolerating distress and improving function. This pilot study is~     designed to test the feasibility of ACT for distress reduction and improved quality of life~     in patients recently diagnosed with early-stage, localized PCa.~   "
111673|NCT01594580|"~     This study will test if nurses wearing scrubs treated with an antimicrobial agent while~     performing patient care will:~      - Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital~     shift during routine use after home laundering~      This study will gather information by obtaining swabs from scrubs treated with an~     antimicrobial and from non-treated scrubs.~   "
111759|NCT01593462|"~     The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE~     (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately~     diagnosing and following Small Bowel Crohn Disease (SBCD) in children.~   "
111674|NCT01594567|"~     Dietary pulses, more commonly known as legumes, are generally recognized as healthy~     components of the diet. Canada's Food Guide encourages consumptions of meat alternatives,~     such as beans more often; and the dietary guidelines for Americans both recommend~     consumption of 3 cups of legumes per week. However, there still remain insufficient~     information on the usefulness of these foods in protecting heart health. To improve~     evidence-based guidance for non-oil-seed pulse recommendations, the investigators propose to~     conduct a systematic review of clinical studies to assess the effect of eating pulses in~     exchange for other foods on measures of heart disease risk and blood sugar control in~     humans. The systematic review process allows the combining of the results from many small~     studies in order to arrive at a pooled estimate, similar to a weighted average, of the true~     effect. The investigators will be able to explore whether eating pulses has different~     effects between men and women, in different age groups, in people with high or normal sugar~     or blood fat levels, and whether or not the effect of pulses depends on how much/often they~     are eaten. The findings of this proposed knowledge synthesis will help improve the health of~     Canadians through informing recommendations for the general public, as well as those at risk~     of heart disease and diabetes.~   "
111675|NCT01594554|"~     A 5-year study to observe and describe long-term patient management and treatment patterns~     with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the~     CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their~     genotype characterized at diagnosis of HCV infection in a real world clinical practice in~     China.~   "
111676|NCT01594541|"~     This retrospective analysis of de-identified data from 700 charts of consecutive patients~     from this patient population is to investigate the prevalence of hyperhomocysteinemia and~     associated metabolic abnormalities in this naturalistic grouping of patients with various~     stages of cognitive loss and diagnosed with various types of dementia.~   "
111677|NCT01594528|"~     Numerous factors can influence the processing of pain message: the affective or emotional,~     the sensorial and the cognitive components. Interindividual variations at the emotional and~     cognitive levels may interfere with the pain message and the consecutive behavior. Some~     modifications in these components are observed in psychiatric troubles, but their influences~     on the behavior to pain have not been studied, although they have been studied in some~     populations characterized as non communicating, with obvious cognitive degradations (subject~     with dementia, older, newborns,…).In an other study in course, the past pain experience is~     explored in relation to results to experimental pain tests, emotional and anxious~     characteristics. This present pilot study aims at studying the infra-verbal behavioural~     signs during experimentally induced pain in subjects with schizophrenia, major depression,~     and controls.~   "
111678|NCT01594515|"~     In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected~     pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.~   "
111679|NCT01594502|"~     The goal of this study is to apply cutting-edge imaging approaches, incorporating~     machine-learning for pattern recognition and multispectral analysis, to the development and~     validation of intermediate endpoint biomarkers in benign tissue that characterize the~     response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer~     among men with negative biopsies.~   "
111680|NCT01594489|"~     The purpose of this study is to determine whether additional therapy with Aminophylline to~     hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective~     to prevent contrast induced acute kidney injury in patients undergoing primary coronary~     intervention for acute ST elevation myocardial infarction.~   "
111681|NCT01594476|"~     Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead~     to negative consequences during the subsequent pregnancy. Providers have traditionally~     delayed starting birth control, especially placement of intrauterine devices (IUDs),~     post-delivery for a number of reasons. The first postpartum visit after a woman has given~     birth is typically scheduled for 6 weeks after her delivery, during which she is typically~     provided with her chosen method of birth control. This study will evaluate two different IUD~     placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to~     determine if placement time affects a woman's follow-through obtaining the IUD and keeping~     it inserted in place. The researchers will also look at bleeding patterns and~     patient/provider satisfaction with the IUD placement~   "
111682|NCT01594463|"~     Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity~     of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be~     associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and~     hospitalization in intensive care unit. The investigators hypothesis that a later third~     trimester routine ultrasound may be more accurate to diagnose late intrauterine growth~     restriction.~   "
111683|NCT01594450|"~     The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single~     blinded trial comparing the use of biological mesh versus traditional wound care without~     biological mesh in patients with an infected incisional ventral hernia. The primary endpoint~     is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate~     at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative~     pain, quality of life, time to healing, need for wound reoperation, impact of the~     cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be~     included.~   "
111684|NCT01594437|"~     The purpose of this study is to compare the safety profile in healthy adult volunteers of~     single or multiple intravenous administrations of TCN-202 as compared with placebo.~   "
111685|NCT01594424|"~     In this Phase I/II trial, 10 highly sensitized patients will be entered after informed~     consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg~     x 5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA~     antibody are seen, patients will progress to kidney transplantation when an acceptable~     crossmatch is achieved with a living donor (LD) or deceased donor (DD). Those receiving~     transplants will also receive Tocilizumab infusion monthly X7 doses post-transplant. All~     subjects will have intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and~     routine post-transplant labs. At 6 months post-transplant, those who have retained their~     transplanted kidney will have a protocol biopsy.~   "
111687|NCT01594398|"~     The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of~     the experimental drug, entinostat, in women with breast cancer and men and women with~     non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated~     when entinostat is given by itself as well as with the approved drugs, exemestane~     (Aromasin®) or erlotinib (Tarceva®). A biomarker (chemical marker in the blood/tissue that~     may be related to your response to the study drug) will also be tested.~   "
111688|NCT01594385|"~     The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who~     are undergoing open abdomen damage control management for traumatic injuries when compared~     to no adhesion barrier use. Specifically, the researchers wish to study the effects of~     Seprafilm adhesion barrier on:~        -  the number and intensity of adhesions,~        -  whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm)~          who go on to successful definitive abdominal closure,~        -  rate of occurrence of secondary complications (such as abscesses) associated with~          short- and long-term beneficial effects of reducing adhesion formation,and~        -  whether there is any difference between treatment groups regarding patient functional~          recovery.~   "
111689|NCT01594372|"~     Investigators intend to conduct a prospective randomized trial to compare vaginal~     hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy~     with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for~     uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they~     have not been compared directly. The investigators hypothesize that there is no difference~     in objective, subjective, or cost-effectiveness between the two procedures for up to two~     years after surgery.~   "
111690|NCT01594359|"~     The purpose of this study is to determine whether beans bred to have a high iron content are~     effective in improving the iron status of young women.~   "
111691|NCT01594346|"~     The purpose of this study is to determine the safety and effectiveness of 2,000~     international units of Vitamin E (alpha tocopherol)on cognitive function of aging persons~     with Down syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36~     months. It is expected that Vitamin E will slow the deterioration in cognitive functions~     associated with Alzheimer disease.~   "
111692|NCT01594333|"~     The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial~     investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death~     in people with type 2 diabetes or metabolic syndrome that have had a heart attack or~     multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood~     Institute (NHLBI)/National Institutes of Health (NIH).~   "
111693|NCT01594320|"~     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian~     flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down~     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test~     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment~     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts~     of the study.~   "
111694|NCT01594307|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 13.5 cm-22 cm.~   "
111695|NCT01594294|"~     The purpose of this study was to assess and compare the effect of the repeated usage of 2~     different care systems (one hydrogen peroxide based cleaning and disinfecting system and one~     PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn~     on a daily wear basis for a 3-month period.~   "
111696|NCT01594281|"~     This study will assess the efficacy and safety of Ranibizumab alone or in combination with~     laser treatment vs. laser treatment alone in Proliferative Diabetic Retinopathy. Efficacy~     will be primarily measured by the change of area of neovascularizations as measured by~     Fluorescein Angiography at month 12 (difference to baseline value).~   "
111697|NCT01594268|"~     A prospective, open label study of CERtican in KIdney transplantation~   "
111698|NCT01594255|"~     This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the~     QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.~   "
111699|NCT01594242|"~     The purpose of this study is to better understand the effects of the chemotherapy medication~     bortezomib on cancer cells. The investigators are therefore taking blood and bone marrow~     samples from patients with myeloma who are receiving bortezomib to see if the investigators~     can detect autophagy in the myeloma cells from the bone marrow and in immune cells in the~     blood. Subjects are eligible if their doctor is planning to treat them with bortezomib for~     the first time for their myeloma.~   "
111700|NCT01594229|"~     This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic~     profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in~     approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study~     will evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects~     when administered in combination with Bendamustine/Rituximab following a dose escalation~     scheme, with the objective of defining the dose limiting toxicity and the maximum tolerated~     dose.~   "
111701|NCT01594216|"~     This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in~     combination with Exemestane in patients with estrogen-receptor positive advanced breast~     cancer. The objective of this study is to determine the preliminary safety and efficacy of~     the combination of exemestane and Ruxolitinib (INCB018424).~   "
111702|NCT01594203|"~     Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in~     60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel~     therapy in advanced cases survival is still short, approximately 12 month.~      Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced~     pretreated STS.~      Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either~     for pre- / post- treatment evaluation or follow up.~      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change~     of treatment as early as possible,when the tumor is non-responsive before serious side~     effects appear or before depletion of body resources.~      The aim of the study is to investigate the contribution of FDG PET/CT to assessment of~     treatment response.~   "
111703|NCT01594190|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of the optimal dose of physical activity in stroke patients immediately after~     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation~     as well as the optimal dose of physical rehabilitation is of great importance for many~     patients, their relatives as well as of a great socioeconomic importance.~      The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical~     activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic~     stroke, gives patients the best improvement in neurological dysfunction.~   "
111704|NCT01594177|"~     Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the~     standard of care in the neoadjuvant setting. In HER2 positive disease trastuzumab is given~     simultaneously. Neoadjuvant anthracycline-taxane-based chemotherapy given simul-taneously~     with trastuzumab achieves a pCR rate of approx. 40%. Recent data showed that a double~     blockade of the HER2 receptor (e.g. trastuzumab + lapatinib; trastuzumab + pertuzumab) given~     together with a few cycles of chemotherapy can increase the pCR rate by approximately 20%.~     So far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker~     can lead to an even more complete blockade of the HER2 pathway when given in combination~     with trastuzumab. The neoadjuvant setting provides the unique opportunity to assess~     precisely and at short term the effect of systemic treatment by assessing the pCR at~     surgery. It also allows treating patients with HER2 positive breast cancer before surgery~     without standard trastuzumab treatment, as, according to current guideline, trastuzumab can~     also be given sequentially after surgery. The aim of the study is to show that chemotherapy~     + trastuzumab + afatinib can achieve significant pCR rates.~   "
111705|NCT01594164|"~     In this study the changes in upper airway geometry and resistance between images, obtained~     in upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography~     (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20~     subjects. The upright morphology will be obtained using CBCT scan while the supine upper~     airway geometry will be determined using a standard High Resolution Computed Tomography~     (HRCT) scanner.~   "
111706|NCT01594151|"~     Asthma in children is recognized as a disease area with a high medical need. As the~     investigators move into this field it is necessary to improve the investigators knowledge of~     upper airway anatomical structure in paediatric patients. This study will provide~     airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can~     be used in order to build models to study the delivery of medication through a device that~     requires for example a facemask. In this study the anatomical structure of the upper airway~     and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan.~     The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.~   "
111707|NCT01594138|"~     The purpose of this study is to determine whether patients who have a high risk for serious~     suicide behavior will demonstrate a speech pattern that has a relationship to language~     patterns found in suicide notes.~   "
111708|NCT01594125|"~     The aim of the study is to investigate the safety, tolerability, efficacy and~     pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to~     curative surgery or loco regional therapy~   "
111709|NCT01594112|"~     The purpose of the THORN registry is to show the ability of Home-Monitoring® to early~     identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients~     (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single,~     dual, or triple chamber).~      The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to~     early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate~     therapies (IT), and to take preventive actions in order to reduce the burden of these~     inappropriate therapies.~      THORN is an observational epidemiologic, prospective and multicenter registry. The primary~     objective is to measure the relative proportion of patients experiencing at least one~     inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess~     the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD~     patients.~   "
111710|NCT01594099|"~     The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin~     /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced~     cervical cancer in elderly women.~   "
111711|NCT01594086|"~     Green tea contains catechins and theanine as major ingredients and has been reported to have~     various beneficial influences on human health. It is reported that the drinking green tea is~     inversely associated with serum homocysteine level in elderly. However the effect of green~     tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this~     study is to investigate the effects of green tea consumption on homocysteine metabolism and~     cognitive dysfunction in elderly with impaired cognitive function.~   "
111712|NCT01594073|"~     Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with~     chronic heart failure and reduced left ventricular ejection fraction (LVEF) <36%.~     Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class~     alone seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT~     study prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects,~     such as operation risk, infection, pneumothorax, lead dislocation, and inadequate icd~     therapy. On the other hand, patients with advanced or end stage heart failure might rather~     die off progressive heart failure death and thus not benefit from ICD therapy.~      It therefore seems appropriate and necessary to improve the individualized risk~     stratification in these patients. The aim of this study is to evaluate multiple cardiac~     biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.~   "
111713|NCT01594060|"~     A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized~     in the medical department. The first approach is called basal-bolus in which 4 insulin shots~     are given daily ( 3 short acting before meals and one long acting before bed time). The~     second approach is called sliding scale in which short acting insulin alone is given before~     meals and before bed time according to the patient's glucose values. The aim is to keep~     fasting glucose between 140-180 mg/dl.~   "
111714|NCT01594047|"~     Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents~     opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal~     surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a~     N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative~     Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia~     after abdominal surgery.~   "
111715|NCT01594034|"~     Our objective is to determine whether or not the presence of hemoperitoneum in trauma~     patients is associated with increased Carbon Monoxide (CO) formation, and to determine if~     elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired~     platelet aggregation, and/or multiple organ failure.~   "
111716|NCT01594021|"~     Induction of general anesthesia induces frequently arterial hypotension. The short term goal~     of this study is to evaluate if preemptive volume loading prevents such complication.~   "
111717|NCT01594008|"~     The goal of the study is to find out whether a high fat meal increases blood lipids and~     causes monocyte (white blood cell) activation, and whether blueberry intake at the same meal~     lessens monocyte activation in healthy people.~   "
111718|NCT01593995|"~     Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has~     demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer.~     But, their use is associated with dermatologic reactions of varying severity. Incidence of~     Erlotinib related skin effect (ERSE) was reported ~75% in NSCLC and pancreatic cancer phase~     III trials. Even though the dermatologic reactions could be a surrogated marker, it may be~     cause of dose modification. Also, it could give significant physical and psycho-social~     discomfort to patients. However, there is still a wide variety of drugs used- including,~     steroid, antibiotics, and vitamin D without any clear evidence based management~     recommendation.~      The role of epidermal growth factor (EGF) has been extensively investigated in normal and~     pathological wound healing. It is implicated in keratinocyte migration, fibroblast function~     and the formation of granulation tissue. The first growth factor to be isolated growth~     factor therapy has progressed into clinical practice in the treatment of wounds.~      Therefore, the investigators propose an epidermal growth factor ointment apply for patients~     with Erlotinib related skin effects.~   "
111719|NCT01593982|"~     Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder,~     symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine~     addicts.~      Several factors indicate that repetitive transcranial magnetic stimulation might be a~     strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and~     cognitive function in cocaine addicts.~      However, up to current days there have been no studies evaluating the effects of Repetitive~     Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals~     suffering from the ADHD.~   "
111720|NCT01593969|"~     The investigators will perform a randomised controlled trial of the provision of food~     designed for rehabilitation of malnourished children that is supplemented with n-3 fatty~     acids compared to usual composition. The investigators want to see whether the provision of~     such a food normalises the deficiencies in essential fatty acids observed in severely~     malnourished children faster than standard composition.~   "
111721|NCT01593956|"~     Concussed athlethes have discrete decreased abilities in motor learning. Recent research~     could further show, that cortical plasticity, as measured by transcranial magnetic~     stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what~     have been found in concussed athletes by paired pulse protocols in TMS.~      GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a~     polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS~     increased tDCS.~      Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed~     athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in~     concussed athlethes.~   "
111722|NCT01593943|"~     The major barrier to India meeting its national goal of replacement fertility is the huge~     discrepancy between urban and rural family planning, with rural young women at highest risk~     for unplanned and unspaced pregnancies. These concerns are considered to drive the~     persistent and unacceptably high rates of maternal and infant mortality in India. Major~     impediments to these young wives' acquisition of family planning services include high male~     partner control over reproductive decision-making, low mobility, and very low access to~     family planning services in villages. Such findings document the need for male-centered~     family planning efforts available at the village level, to better meet the needs of rural~     young wives. These male-centered efforts must address male gender role and gender inequity~     ideologies and norms (e.g., son preference, wife abuse) and marital communication, as these~     factors are associated with lower likelihood of contraceptive use in rural young Indian~     couples. Hence, the proposed study involves development and testing of the CHARM Program, a~     gender equity (GE)-focused, male-centered family planning (FP) program delivered by village~     health providers (VHPs), via a public-private partnership with primary health centers (PHCs)~     and private providers serving rural India. In Phase 1 the investigators will conduct~     formative research including health care resource mapping of Vasai within the Thane district~     of Maharashtra to identify villages and VHPs for inclusion in subsequent research and~     intervention. The investigators will also conduct in-depth interviews with rural young~     husbands (n=30), rural young wives (n=20), and health care providers (n=12), as well as~     focus groups with mothers' of rural young husbands (n=40). These data will be used to~     develop the CHARM program and efficacy trial. Phase 2 will involve development and pilot~     testing of CHARM protocols and training of VHPs for their role in the intervention trial~     (Phase 3). The CHARM intervention will involve VHP-delivered GE and FP counseling. It is~     delivered via a single session with 2 optional additional sessions one of which would~     include their wife. Phase 3 will involve evaluation of CHARM, using a two-armed randomized~     controlled trial design. Villages (N=50) will be randomized to receive either CHARM or the~     control program (standard FP referral to government public health centers [PHCs] located~     outside of villages), to assess treatment impact on spacing contraceptive use, pregnancy,~     and unmet family planning need. Intervention effects will be assessed via behavioral surveys~     with rural young husbands (18-30 years) and their wives (N=1000 couples, 20 couples per~     village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests from wives,~     conducted at baseline and 18 month follow-up. A process evaluation will be undertaken via~     interviews with study participants and VHPs, as well as through VHP interviews and clinical~     record review, to assess program adherence, participation rates, response to program, and~     ease of delivery. In-depth interviews will also be conducted with key informants from the~     village and public and rural health systems to assess sustainability and~     institutionalization of the model.~   "
111723|NCT01593930|"~     The purpose of this study is to determine the success rate of pulpal anesthesia in~     mandibular firs molar following infiltration of 4% articaine alone and as supplemental~     injection after inferior alveolar nerve block(IANB).~   "
111724|NCT01593917|"~     To collect long term follow up study data of the Trifecta valve in subjects who had the~     Trifecta valve implanted during the IDE study.~   "
111725|NCT01593904|"~     1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS~          patients and controls.~        2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain~          perfusion and Cerebrospinal flow before and after the procedure on a large number of~          patients to determine these outcomes~   "
111726|NCT01593891|"~     Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic~     Cerebral Spinal Venous Insufficiency Treatment~   "
111727|NCT01593878|"~     This study aims to test whether middle school students test performance is affected by~     background TV. Students will complete a high school entrance exam either with or without a~     TV on in the test room. Scores will be compared.~   "
111728|NCT01593865|"~     The present study hypothesizes that the systematic use of bilateral internal mammary artery~     (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for~     the treatment of multivessel coronary artery disease (primary hypothesis). The secondary~     study hypothesis is that the BIMA grafting meets the safety endpoint compared with the~     conventional surgical strategy entailing left mammary artery grafting plus great saphenous~     vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis~     is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms~     related to coronary disease, of repeat revascularization and of cardiac mortality compared~     with patients treated with the conventional surgical strategy entailing left mammary artery~     grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.~   "
111729|NCT01593852|"~     Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image~     noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality .~      The primary aim of this study is to verify if a significant reduction in total procedural~     X-ray dose during electrophysiological interventions can be achieved by using advanced image~     processing (Allura Clarity).~   "
111730|NCT01593839|"~     The main objective of this study is to investigate the muscle metabolism in individuals with~     chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back~     pain.~   "
111731|NCT01593826|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler~     with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the~     bloodstream.~   "
111732|NCT01593813|"~     The theoretical benefits of the repair of the pronator quadratus include flexor tendon~     protection, remain of the normal pronation-supination range of motion (ROM) and strength,~     and keeping the stable DRUJ.~      Repair or not repair pronator quadratus in the volar plating of distal radial fracture-Are~     functional outcomes differ?~   "
111733|NCT01593800|"~     Lactose intolerance (LI), also known as lactose malabsorption is the most common type of~     carbohydrate malabsorption. It is associated with the inability to digest lactose into its~     constituents, glucose and galactose, due to low levels of lactase enzyme activity (1-2). At~     birth, lactase activity is at the highest and it declines after weaning (1-2). The~     unabsorbed lactose is metabolized by colonic bacteria to produce gas (hydrogen (H2) and~     methane (CH4)) and short chain fatty acids. Symptoms related to LI appear 30 minutes to 2~     hours after consumption of food products containing lactose. Related symptoms include:~     bloating, cramping, flatulence and loose stool (1-2, 17-18).~      Highest rates of LI are found in the Asian populations, Native Americans and African~     Americans (60-100%), while lowest rates are found in people of northern European origin~     (including northern Americans) (3-4).~      The diagnosis of LI based on patients' symptoms is sometimes problematic, since these~     symptoms are not specific and may differ from one patient to another. Breath hydrogen test~     have been advocated as the best diagnostic tool for the assessment of LI (15-16). During the~     test, subjects are sampled for hydrogen levels of breath samples at base line and every 30~     minutes after the administration of 50 grams of oral lactose, for a total period of 180~     minutes. A breath sample with > 20 ppm above baseline is considered positive for LI (15-16).~      There are no established treatments for LI, other than almost complete avoidance of lactose~     rich dairy products. Avoidance of dairy products is a major concern since its outcome may~     result in a dietary calcium intake that is well below recommended dose of 1,000 mg per day~     for men and women and 1,300 mg for adolescents (8-10). For this reason different course of~     action needs to be considered instead of a complete exclusion of dairy products by LI~     patients.~      Two possible interventions in the case of LI are the supplement of commercially available~     lactase (tablets) or the addition of probiotics.~      The consumption of lactase enzyme as a food supplement may assist in restoring adequate~     levels of the enzyme needed for hydrolysis of lactose, especially for patients with low, or~     non existent levels of lactase. On the other hand, lactase products are problematic since~     not all lactase preparations are of the same concentration. Moreover, it is difficult to~     asses the amount of lactase tablets needed in order do fully hydrolyze lactose in each dairy~     mill (14).~      Probiotics are live microorganisms that are commonly used in order to prevent or treat a~     disease. The current definition by the Food and Drug Administration and the World Health~     Organization is Live microorganisms which, when administered in adequate amounts, confer a~     health benefit on the host. These microorganisms are a heterogeneous group, they are~     nonpathogenic and produce beta- galactosidase or lactase intracellularly that may assist in~     the digestion of lactose (11).~      Studies have shown that people with lactose intolerance tolerated the lactose in yogurt~     better than the same amount of lactose in milk. The assumption was that the presence of~     lactase producing bacteria in the yogurt, especially Lactobacillus acidophilus, contributed~     to the digestion and absorption of lactose (5-6, 13).~      It was also found that the presence of Lactobacillus bulgaricus and Streptococcus~     thermophilus alleviate lactose intolerance through their ability to produce lactase enzyme~     (7).~      Finally, in another study it was found that consumption of milk containing Bifidobacterium~     longum resulted in significantly less hydrogen production and flatulence as compared to the~     consumption of control pasteurized milk (12).~      Based on the mentioned data, the investigators speculate that the administration of~     probiotics may assist with the consumption of dairy products containing lactose. Therefore,~     the aim of this study is to evaluate the effect of probiotics on patients with LI.~   "
111734|NCT01593787|"~     This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive~     patients with renal dysfunction.~   "
111735|NCT01593774|"~     The purpose of this study is to determine whether melatonin can prevent metabolic side~     effects of olanzapine such as weight gain, elevated glucose concentrations and lipid~     abnormalities.~   "
111736|NCT01593761|"~     Primary Objective:~      To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with~     cABSSSI (major cutaneous abscesses) due to MRSA.~      Secondary Objective(s):~        -  To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due~          to MRSA~        -  To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.~        -  To assess the safety of multiple doses of CG400459~   "
111737|NCT01593748|"~     This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs~     Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this~     study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with~     Gemcitabine and Docetaxel in participants with soft tissue sarcoma.~   "
111738|NCT01593735|"~     This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts.~     Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part~     II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently~     or may be staggered.~   "
111739|NCT01593722|"~     Background:~        -  Loa loa is a small worm that infects people in West and Central Africa. It is spread by~          the bite of a fly. Adult worms live under the skin and can cause swelling in the arms,~          legs, and face. Some people have more serious infections in the heart, kidneys, or~          brain. Most people with Loa loa infection have no symptoms at all. The standard~          treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some~          people have bad reactions to DEC, including itching, muscle pains, and in severe cases~          coma and death.~        -  Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread~          of worm infections that cause blindness and massive swelling (elephantiasis). However,~          people who also have Loa loa have had serious bad reactions to ivermectin. Researchers~          want to study both DEC and ivermectin to find out why these reactions occur. If they~          can be prevented, mass drug treatment programs will be able to be used in areas in~          Africa where Loa loa exists.~      Objectives:~      - To study the side effects of DEC and ivermectin treatment for Loa loa infection.~      Eligibility:~      - Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist,~     who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level~     of Loa loa parasites in the blood, but are otherwise healthy.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected to check for Loa loa infection. Participants will also have an eye~          exam and provide skin samples to check for other worm infections that may interfere~          with the study treatment.~        -  Participants will be admitted to the hospital for 4 days (during and after the~          treatment). They will receive a single dose of either DEC or ivermectin.~        -  After treatment, regular blood samples will be collected. Participants will be asked~          questions about how they feel after treatment. Physical exams will be performed. If~          side effects develop, participants will be treated at the hospital.~        -  After leaving the hospital, participants will have followup visits. These visits will~          happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a~          short physical exam and collection of blood samples.~        -  At the end of the study, participants will be offered a full 21-day DEC treatment to~          cure the Loa loa infection.~   "
111740|NCT01593709|"~     Background:~      - Vaccines and antiviral therapies are critical for preventing and treating viral diseases.~     Testing these vaccines and drugs often requires healthy volunteers. To ensure that~     volunteers are healthy and eligible to participate in these studies, they will be screened~     before the start of the study. This screening may involve a medical history, physical exam,~     and blood test. Other samples may also be collected. This study will help identify~     volunteers who are eligible to participate in vaccine or antiviral therapy trials.~      Objectives:~      - To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus~     infections.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Screening may begin several months before the start of the clinical trial. Participants~          may come to the National Institutes of Health clinic one or more times.~        -  Participants may be screened with a physical exam and medical history. Blood samples~          will be collected. Other samples may also be collected, including urine, nasal wash,~          nasal swab, or stool samples. All samples will be stored for reference by the study~          researchers....~   "
111741|NCT01593696|"~     Background:~      - Although progress has been made in treating children with B-cell cancers such as leukemia~     or lymphoma, many children do not respond to the standard treatments. One possible treatment~     involves collecting white blood cells called T cells from the person with cancer and~     modifying the cells to attack the B-cell cancer. The cells can then be given back to the~     participant. This study will use T cells that have been modified to attack the CD19 protein,~     which is found on the surface of some B-cell cancers.~      Objectives:~      - To see if anti-CD19 modified white blood cells are a safe and effective treatment for~     children and young adults with advanced B-cell cancer.~      Eligibility:~        -  Children and young adults between 1 and 30 years of age who have B-cell cancer~          (leukemia or lymphoma) that has not responded to standard treatments.~        -  The leukemia or the lymphoma must have the CD19 protein.~        -  There must be adequate organ function.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies or bone marrow biopsies may be performed~          depending on the type of cancer.~        -  Participants will undergo a process where white blood cells are collected, called~          apheresis. These cells will be modified to contain the anti-CD19 gene.~        -  Participants will have 3 days of chemotherapy to prepare their immune system to accept~          the modified cells.~        -  Participants will receive an infusion of their own modified white blood cells. They~          will remain in the hospital until they have recovered from the treatment.~        -  Participants will have frequent follow-up visits to monitor the outcome of the~          treatment.~        -  If the participant benefits from the treatment, then he/she may have the option for~          another round of treatment.~   "
111742|NCT01593683|"~     The purpose of this study is to test a brief education program for oncology nurses, to~     enhance their skills for managing psychosocial stressors associated with providing direct~     patient care. The investigators will explore efficacy of the intervention for reducing~     psychological stress and medical errors.~   "
111743|NCT01593670|"~     This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat~     twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural~     killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell~     survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The~     intent is to administer all treatment in the outpatient setting.~   "
111744|NCT01593657|"~     The purpose of this clinical trial is to understand if women undergoing surgery for a~     suspected gynecologic malignancy are interested in participating in a Mindful Movement and~     Breathing program and what the effects of this program are on women and the surgery-related~     symptoms they experience. Mindful Movement and Breathing programs may be effective for~     easing distress, post-surgical pain, and other symptoms of surgical procedures.~   "
111745|NCT01593644|"~     The purpose of this study is to evaluate the efficacy and tolerance of a~     dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to~     adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary~     flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using~     transthoracic echodoppler~   "
111746|NCT01593631|"~     Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose~     malabsorbers than unfermented dairy products. The intake of dietary supplements containing~     acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to~     reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to~     compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to~     the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose~     malabsorbers. It is hypothized that the combination preparation will be more effective~     and/or will show a more reliable effect than the two mono-preparations.~   "
111747|NCT01593618|"~     This is a randomized controlled trial of a web-based informational intervention (UMFollowUp)~     for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and~     psychosocial functioning.~   "
111748|NCT01593605|"~     The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their~     ability to control glucose levels in persons without diabetes but with impaired fasting~     glucose. Secondary assessments will examine the effect of these nutritional supplements~     versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term~     metabolic markers of risk in diabetes.~   "
111749|NCT01593592|"~     Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.~   "
111750|NCT01593579|"~     Some Akt inhibitors have produced functional cardiovascular effects such as marked~     hypotension that may limit their clinical benefit. There are no current data on whether this~     autonomic failure presents in humans at clinically used doses. We will test the hypothesis~     that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.~   "
111751|NCT01593566|"~     Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for~     analgesia after Anterior Cruciate Ligament (ACL) reconstruction.~   "
111752|NCT01593553|"~     The purpose of this study is to determine whether screening for atrial fibrillation by~     intermittent ECG recording and initiation of anticoagulation treatment among high risk~     individuals is cost-effective and can lower the incidence of stroke.~   "
111753|NCT01593540|"~     The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding~     Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig~     metal-core interdental brush.~   "
111754|NCT01593527|"~     The purpose of this study is to confirm the efficacy and safety results obtained in a~     chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a~     larger, independent patient population with difficult to treat gouty arthritis and moderate~     to severe CKD (stage 3 - 4).~   "
111755|NCT01593514|"~     The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N~     meningitidis is classified into different serogroups (types), based on its outer~     polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W & Y are responsible for the vast~     majority of meningococcal disease worldwide.~      Older vaccines against types A,C,W & Y contain part of the polysaccharide capsule of the~     germ. However, these polysaccharide vaccines do not provide long-term protection against~     disease and are less effective in young children, the group most at risk of meningococcal~     disease. Newer conjugate ACWY vaccines attach a polysaccharide to a protein carrier -~     these provoke a good response in young children and can provide long-term protection.~      White blood cells called B cells produce antibodies, which are the main components of~     protection against meningococcal disease. Although many studies have investigated the immune~     response to these vaccines in different age groups by measuring specific antibodies, there~     is limited information about the B cells underlying such an immune response. Several~     different subsets (populations) of B cells exist in the blood. Previous studies by the~     investigators group suggest that different numbers of B cells are produced in response to~     each vaccine type. However, little is understood about which subset of B cell is important~     for antibody production in response to these polysaccharide or conjugate vaccines.~      This study aims to provide detailed information on the immune response to meningococcal~     vaccines by investigating the appearance of B cells and their subsets in the blood after~     vaccination with the polysaccharide and conjugate vaccines. These observations will help us~     understand how polysaccharide and conjugate vaccines stimulate the immune system in~     different ways. This knowledge will help in the development of new vaccines that are~     effective across all age groups.~      The investigators aim to recruit 20 adults aged 30-70 from Oxfordshire. The study will be~     funded by the Oxford Vaccine Group.~   "
111756|NCT01593501|"~     The investigators aim to recruit 60 women who have agreed to participate in an existing~     randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency,~     HSC 2009-0055). In this trial, the investigators propose to evaluate the associations~     between magnesium intake, magnesium stores, fractional magnesium absorption and calcium~     homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that~     approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and~     high-dose vitamin D). The investigators already assess calcium homeostasis throughout the~     study by measuring bone mineral density, fractional calcium absorption, serum and urine~     calcium levels, among other tests. In the sub-study of 60 women, the investigators will~     evaluate whether habitually higher magnesium intake increases or decreases fractional~     calcium absorption. The investigators will evaluate the interplay between magnesium stores,~     vitamin D levels and serum parathyroid hormone levels. The investigators will directly~     assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will~     measure magnesium absorption using the dual stable isotope approach.~   "
111757|NCT01593488|"~     The purpose of this study is to describe the activity and toxicity of a new formulation of~     cytarabine called liposomal cytarabine given into the central nervous system for the~     treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in~     children and adolescents.~   "
111761|NCT01593436|"~     Summary~      Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the~     investigators analyzed, often related to stress states acquired, generalized anxiety and~     stress, which are important factors that disrupt normal sleep. The investigators point out a~     fact that still intrigue the students of medicine and sleep that is distorted perception of~     sleep by the sleepless nights, polysomnography shows greater effectiveness than that~     perceived by them. On the other hand, there is evidence that mindfulness techniques may~     reduce symptoms of stress and anxiety as well as improve the general attention, which may~     contribute to a better perception of the effectiveness of sleep. In addition, there are~     studies showing that meditation is associated with metabolic and neurophysiological~     characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women~     trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and~     also assess the quality of sleep experienced meditators menopausal comparing them to the~     group of healthy postmenopausal women untrained in the art.~   "
111762|NCT01593423|"~     The project is a three arm randomized control trial in rural Cambodia designed to evaluate~     the impact of homestead food production (home gardens) with and without fish ponds versus~     control on household food security, dietary intake of women and youngest child, biochemical~     nutritional status of women, and household livelihoods over a 22 month period. Baseline and~     end line surveys will be conducted that involve questionnaires and a blood sample.~   "
111763|NCT01593410|"~     The purpose of this study is to determine the efficacy of lenalidomide plus low-dose~     dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma.~      Even though the efficacy and safety of lenalidomide has already been well-demonstrated in~     other populations including Asians, this study will assess the efficacy and safety as well~     as pharmacokinetics of lenalidomide in Chinese subjects. In addition, this study will~     generate clinically meaningful information in guiding the therapeutic use of lenalidomide~     for Chinese subjects.~   "
111764|NCT01593397|"~     The primary objective of this study is to determine the influence of insulin resistance on~     drug metabolism and response in obese subjects. The investigators hypothesize that~     expression of adiponectin (a hormone secreted by fat tissue), and specific variants in the~     adiponectin gene can predict the insulin resistance and drug response among obese subjects.~   "
111765|NCT01593384|"~     Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion~     detection in dense breasted women. Even though DBT has been regarded as a study for dense~     breasted women, it may also improve lesion detection at an earlier stage and smaller size in~     women with less dense breast tissue. The overlapping of tissue on a standard of care 2D~     mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that~     mimic cancers. This leads to patients being asked to come back for additional imaging~     including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by~     up to 43% in reader studies. Even though these results are promising they were not done in a~     realistic clinical setting.The purpose of this study is to evaluate the FDA-approved~     combination standard digital mammography (DM) and DBT technology and its impact on our~     clinical practice.~   "
111766|NCT01593371|"~     Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients~     with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as~     metformin), are two major groups of hypoglycemic medications that while function via~     different pathways, are both effective in short- and long-term glycemic control . These~     medications diminish or at least delay long term micro- and macrovascular complications~     associated with prolonged insulin resistance although at different rates. The mechanisms by~     which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a~     key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic~     agents might regulate these substances by direct and indirect routes.~   "
111767|NCT01593358|"~     To establish if there are venous obstructions in patients with neurodegenerative disorders~   "
111768|NCT01593345|"~     The population is aging and chronic conditions, which are major causes of pain and mobility~     limitations, are on the rise, however, current access to physiotherapy is difficult.~     Knowledge on managing disability is substantial, but methods to translate into action are~     lacking. This project is designed to test a novel method of promoting function in vulnerable~     seniors and simultaneously develop awareness in the new generation of physiotherapists that~     they can have a proactive role in health promotion. The investigators are proposing a pilot~     project targeting both students and patients.~      The research question are (1) What are the needs of vulnerable patients at the MUHC? Two~     groups will be targeted; newly discharged seniors (who will be eligible for an intervention)~     and cancer outpatients who will be surveyed only);(2) For a senior population at risk for~     physical deterioration, to what extent is a personalized mentoring approach to optimizing~     function and preventing disability through developing self-management skills more effective~     in improving outcomes than the provision of written material covering the same general~     content? (3) Does a mentoring experience with vulnerable seniors through development and~     teaching of a self-management program (comprised of education and support) produce~     meaningful positive changes in future clinicians' knowledge, skills and attitude towards~     modes of delivering physiotherapy services and promoting self-management in Canadian~     seniors?~      There are two phases to this study: a survey and randomized controlled trial (RCT). The~     survey phase will identify mobility needs of two groups, newly discharged seniors and cancer~     outpatients. The needs assessment for newly discharged seniors will identify people eligible~     for the (RCT) component; the needs assessment for cancer outpatients will inform the~     development of interventions for this specific group. The RCT component will be piloted for~     recently discharged community dwelling seniors 70 years and older only.~      A sample of 400 seniors recently discharged from the adult, general, hospital sites of the~     MUHC will be contacted for a needs assessment. From this pool, the investigators anticipate~     100 will be eligible and 60 will be randomized, 30 to the mentor intervention and 30 to the~     control group. Participants will be followed-up for 6 months and assessments will be~     performed at 2 time points (baseline and 6 months). The main outcome is a standardized~     response ratio (SRR) estimated across all persons and measures. SRRs will be calculated for~     three groups of response variables: impairment/mobility measures, quality of life~     indicators, and health services outcomes.~      In parallel, to determine cancer survivor needs, the investigators will contact 600 cancer~     survivors; as the investigators anticipate 400 will answer the survey. The analysis of this~     survey will consist of frequency of specific needs by diagnosis and treatment.~   "
111769|NCT01593332|"~     In this project the investigators decide to evaluate the efficacy and safety of half dose~     mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of~     rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs~     limited in the investigators refractory patients as the first line drugs because of its~     cost.~   "
111770|NCT01593319|"~     The main hypothesis of the study is that anaesthesia of the hip using infiltration with a~     local anesthetic solution is preferable over traditional analgesia with oral opioid~     medications in the acute stage of the management of patients with a fracture of the hip.~      To study the hypothesis the investigators designed a prospective randomised study where~     patients are assigned in two groups, the first receiving local hip anesthesia and the other~     placebo treatment. Both groups are eligible to use of standard oral pain treatment.~      Effect of analgesia as well as medical complications will be recorded.~   "
111772|NCT01593293|"~     The number of NSCLC patients above 70 years of age who are non-squamous histology is~     increasing around the world. Although previous guidelines often recommend single agent~     therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard~     monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with~     non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy~     in terms disease progression, overall survival, and quality of life and tolerability.~   "
111773|NCT01593280|"~     Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea~     and pruritus, which may affect quality of recovery. The investigators hypothesize that~     long-acting local anesthetic infusions via TAP catheter can provide better quality of~     recovery after cesarean section than spinal morphine.~   "
111774|NCT01593267|"~     With evolving endovascular technologies there is a growing debate centered on the relative~     safety and efficacy of the currently accepted alternatives for the treatment of ruptured~     cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this~     study is to compare the safety and efficacy of microsurgical clipping and endovascular~     coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.~   "
111775|NCT01593254|"~     The purpose of this study is to test the hypothesis that patients with CML who have not~     achieved optimal response after 3 months of treatment with imatinib will have a better~     response by switching to dasatinib compared to staying on their original imatinib regimen.~   "
111776|NCT01593241|"~     The main objective of this trial is to test the efficacy and safety of carboplatin~     chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.~   "
111777|NCT01593228|"~     The purpose of this study is to assess the safety and tolerability of iniparib administered~     as monotherapy or in combination regimens in patients previously treated with iniparib in a~     clinical study and who have derived clinical benefit after completion of the parental~     study's objectives.~   "
111778|NCT01593215|"~     The investigators have recently discovered a genetic variant in an adrenergic receptor that~     leads to increased risk for type 2 diabetes. The investigators have also seen that blockers~     of that receptor improves impaired insulin secretion in animals. The investigators will now~     test the blocker in patients with type 2 diabetes with or without the risk variant in an~     effort to make diabetes treatment more individualized.~   "
111779|NCT01593202|"~     The purpose of the study is to evaluate the long-term efficacy of dialectical behavior~     therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced~     usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been~     included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was~     repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of~     outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have~     been assessed so far on five different time-points: baseline (before starting treatment), 9~     weeks, 15 weeks, 19 weeks and 71 weeks after start of the treatment. In the current project~     patients will be assessed a 6th time 2 years after treatment completion.~      The main study hypotheses are:~        -  DBT will be significantly more efficacious in reducing the number of self-harm episodes~          with or without intent to die, as well as reducing the number of emergency room visits~          for self-harm or suicidal behaviour, compared to EUC.~        -  DBT will be significantly more efficacious in reducing the level of suicidal ideation~          and depressive symptoms compared to EUC.~   "
111780|NCT01593189|"~     This study focuses on children entering kindergarten with co-occurring developmental~     disabilities and behavior problems, a population especially likely to have low levels of~     school readiness. Prior research has shown that children with developmental disabilities are~     at risk for academic difficulties. Behavioral and social problems are likely to interfere~     with school adjustment. The investigators hypothesize that children who receive the~     intervention will show better school readiness and school adjustment outcomes.~   "
111781|NCT01593176|"~     The investigators are doing this research study to look at how distal femoral fractures~     (knee bone break) heal. In this study, the investigators will use Radiostereometric Analysis~     (RSA) to look at how the pieces of femur bone move as the bone heals. RSA is a special x-ray~     that uses radiographs to measure very small movements in the bone over time. The question~     that will be answered by this study is whether RSA can be used as a tool to monitor fracture~     healing.~   "
111782|NCT01593163|"~     Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it~     has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA~     treatment according to the last version of the Cochrane review. Nowadays the best dose~     regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized~     controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen~     treatment versus standard treatment could reduce the number of doses of ibuprofen without~     increasing the reopening rate and reducing the side effects associated to this medication.~   "
111783|NCT01593150|"~     Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60~     years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of~     life, increased morbidity, mortality and health economic costs.~      Presentation of AF differs substantially among patients ranging from self-limiting short~     episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC)~     cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually~     tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard~     treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant~     treatment with Warfarin. According to guidelines DC-cardioversion can be performed when~     anticoagulation treatment has been in therapeutic range for at least 4 weeks. However~     introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time~     to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF~     contributes to left atrial remodeling and increases in inflammatory and neurohumoral~     biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the~     risk of AF recurrence after DC-cardioversion.~      Early cardioversion of patients with persistent AF is possible if preceded by~     transesophageal echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in~     the ACUTE study, is a safe and efficient alternative to conventional treatment. This~     treatment regime is not routinely used in clinical practice.~      The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional~     treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be~     randomized to early cardioversion preceded by TEE in accordance with guidelines or~     conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion.~      The investigators will determine the outcome in the two groups regarding:~        -  Left atrial function and size assessed by left atrial strain, left atrial ejection~          fraction and left atrial volume.~        -  Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP.~        -  Time to recurrence of AF (AF documented by ECG or Holter monitoring)~      Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring~     will be performed at the time of randomization, 4 weeks, 3 month and 6 month post~     DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence~     for a period of one year. AF recurrence will be documented by 12 lead ECG.~   "
111784|NCT01593137|"~     The process of atherosclerosis is multifactorial and involves many mechanisms. The majority~     of published works have identified endothelial dysfunction as the first step in a cascade of~     events that culminates in plaque formation. Among the various mechanisms that occur~     following the attack on the vessel wall, it is thought that stem cells in the form of~     endothelial progenitor cells (EPCs) are the endothelial protection mechanism.~      Factors identified as cardiovascular risk factors, or rather those conditions which suppose~     a threat to the vessel wall, should therefore be associated with low levels of EPCs. To date~     this link has been shown in hypertension, diabetes, hyperlipidaemia, and smoking.~     Furthermore, the lack of wall protection in situations of low levels of EPCs is clearly a~     biomarker of cardiovascular morbidity and mortality.~      On the other hand, the correction of a risk factor allows recuperation of EPCs and is~     therefore showing itself to be a promising tool for measuring therapeutic efficacy.~      The tools for correcting EPC levels are not clearly defined. The effect of statins on levels~     of EPC has been shown, and the low levels of EPCs in diabetes seem to be susceptible to~     treatment with statins.~      The role of glucagon-like peptide (GLP-1) is slowly being elucidated but the actual~     mechanism of its potential endothelial protection is unknown, and its effect on EPCs has not~     been studied.~      Liraglutide, a long-acting GLP-1 analogue, could also be an interesting option for long-term~     vessel wall protection, but to date its ability to correct cardiovascular biomarkers such as~     EPCs has not been studied.~   "
111785|NCT01593124|"~     This study investigates the response of vaginal and cervical tissue after exposure to three~     vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ)~     cream.~   "
111786|NCT01593111|"~     Exposure to household allergens is a major contributor to asthma symptoms. Aggressive~     measures to reduce household allergens has the potential to reduce asthma symptoms and the~     need for medications to control asthma. The investigators plan to enroll patients aged 6 and~     above into a single blind, randomized study comparing intensive environmental intervention~     with usual asthma care over a 48 week study period. All subjects will have asthma treatment~     optimized according to guideline based care. Subjects will be randomized to an aggressive~     environmental remediation arm versus distribution of written materials regarding allergen~     reduction (usual care). Primary outcome measure will be ability to reduce asthma step~     therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality~     of life.~   "
111787|NCT01593098|"~     To prospectively determine the prevalence of colorectal neoplasia in siblings of Hong Kong~     Chinese patients with advanced neoplasm compared with a sex and age-matched control~     population. To determine the molecular alteration profiles of colonic adenomas in siblings~     of patients with advanced neoplasm~   "
111788|NCT01593085|"~     The investigators propose a study that aims to develop a methodology for assessing this risk~     and the psychological consequences of the malignancy in the palliative phase.~   "
111789|NCT01593072|"~     The purpose of this study is to evaluate the safety and tolerability of healthy male and~     female subjects with intravenous (IV) infusions of AVI 7537 compared to matched placebo in~     and to evaluate the pharmacokinetics (PK).~   "
111790|NCT01593059|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
111791|NCT01593046|"~     LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety,~     tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a~     long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to~     3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or~     subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone~     for 2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months.~     For the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be~     given alone. Three dose levels of GSK1265744 will be evaluated partly in combination with~     TMC278 LA to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability,~     and PK profile. A total enrolment of approximately 40 healthy subjects is planned for this~     study.~   "
111792|NCT01593033|"~     The purpose of this study is to investigate the therapeutic effectiveness of micronutrients~     (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut~     absorptive and immunological function as measured by the dual sugar permeability test and~     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental~     Enteropathy.~   "
111793|NCT01593020|"~     The goal of this clinical research study is to learn if and how well eribulin, given in~     combination with standard chemotherapy, can treat early-stage breast cancer compared to~     paclitaxel given in combination with standard chemotherapy. In this study, the standard~     chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called~     FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).~      Eribulin is a changed version of the structure of a natural substance from a sea sponge. It~     is designed to block cells from dividing, which may cause cancer cells to die.~      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.~      5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow~     or stop their growth and spread throughout the body. This may cause the cancer cells to die.~      Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop~     their growth and spread throughout the body. This may cause the cancer cells to die.~      Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to~     die.~      Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may~     slow or stop their growth and/or keep them from spreading throughout the body. This may~     cause the cancer cells to die.~   "
111807|NCT01592838|"~     This study aims to investigate whether a change in the pattern of hospitalisation was~     observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change~     in staff workforce availability was observed in paediatric wards over the last 6 years~     (during a whole year or during specific time periods of the year) and if changes of any of~     the variables measured during the observation period could be linked to the introduction of~     rotavirus vaccination.~   "
112068|NCT01589406|"~     Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete~     questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment~     (surgery or radiotherapy) and after completion of treatment in order to estimate the~     influence of disease and treatment on quality of life indices.~   "
111794|NCT01593007|"~     Objectives: To evaluate regional lung ventilation distribution in patients suffering from~     chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate~     it with functional capacity and quality of life among these individuals. Methods and~     Results: Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before~     and after muscle training, subjects were submitted to assessment protocol for respiratory~     muscles, digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test~     (6MWT) and a quality of life questionnaire (MLHFQ). There was no difference in lung function~     following the 12-week training period in either group. However, the IMT group showed an~     increase in actual and predicted MIP, higher MLFHQ score and greater distance walked in the~     6MWT, as well as a reduction in the Borg scale after the 6 MWT in relation to the control.~     For the OEP, IMT group members exhibited higher values for total chest wall volume (Vcw),~     abdominal rib cage volume (Vrc,a) and abdominal volume (Vab) when compared to the control.~     Conclusions: For patients with CHF, IMT proved efficient in improving muscle strength,~     functional capacity and quality of life. The present study also analyzed the distribution~     behavior of lung volumes for the thoracoabdominal system in this population, showing that~     larger abdominal rib cage and abdomen volumes may result in more effective diaphragmatic~     contraction.~   "
111795|NCT01592994|"~     This grant involved the development, implementation, and assessment of the feasibility and~     acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives~     (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was~     adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV~     intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was~     from their primary male partner (Raj et al. 2001).~      Specific aims of this study are as follows:~        1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with~          demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use~          with at-risk Indian wives.~        2. To determine the feasibility and acceptability of RHANI Wives with at risk wives* in~          India. A two-group cluster randomized trial will involve random assignment of 12~          neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a~          control condition (n=150). Intervention effects on the more proximal and likely safer~          sex mediating outcome of marital communication for this feasibility trial will be~          assessed via surveys at baseline and 3 month follow-up.~      NOTE: Only 220 participants were able to be recruited into the study.~      *At risk wives are defined as having a husband at higher risk for transactional sex based on~     wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7~     days) or partner violence perpetration~   "
111796|NCT01592981|"~     The purpose of this trial is to assess tolerability and efficacy of the Bortezomib,~     Cyclophosphamide and Rituximab combination as initial therapy for previously untreated~     patients with symptomatic Waldenstrom's macroglobulinaemia.~   "
111797|NCT01592968|"~     The goal of this clinical research study is to compare stereotactic radiosurgery to whole~     brain radiation therapy in patients with 4-10 non-melanoma brain tumors.~      Stereotactic radiosurgery is the delivery of focused, high-dose radiation given in a single~     session to the tumors with a minimal dose given to uninvolved areas of the brain.~      Whole brain radiation is the delivery of lower dose radiation to the entire brain given~     daily over 2 weeks.~   "
111798|NCT01592955|"~     The purpose of this study is to evaluate the effectiveness and the safety of the~     cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma~     patients~   "
111799|NCT01592942|"~     This is a prospective, randomized multi-centre study to find out most safe, feasible,~     painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh~     fixation techniques are compared to find out best technique in local anaesthesia~     Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap~     method compared to conventional Lichtenstein technique.~   "
111800|NCT01592929|"~     In this study the possible changes in upper airway geometry induced by variations in the~     characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory~     imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.~      Different mouthpiece designs will be evaluated for each subject by using magnetic resonance~     imaging (MRI) scans. The results will help to identify the influence of the height, width,~     protrusion and resistance of the mouthpiece on upper airway geometry.~      Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece~     variants, in supine and upright position, will be completed.~      A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper~     airway will be taken to respectively compare the time dependence on 3D imaging with MRI and~     to provide a 3D image in an upright position.~      Dental impressions will be optically scanned to obtain a more accurate representation of the~     oral cavity, mainly in MRI.~   "
111801|NCT01592916|"~     The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have~     shown that exercise improves body functions and/or symptom severity in most patients, but~     not in all. About a third of patients with FM have been shown to have low levels of IGF-1.~     The purpose of this project is to study individual and biological factors that interact with~     outcomes of short-term (acute) exercise in FM.~      Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy~     age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer~     bicycle exercise tests will be conducted in feasting patients, separated by one month. The~     first exercise test is at a low and the second at a high intensity. Measurements comprise~     blood test, pain rating and pain threshold, conducted before and after the test. The levels~     of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health~     status and pain.~   "
111802|NCT01592903|"~     The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC)~     responsible for the formation and growth of leiomyomas using the Side Population method.~   "
111803|NCT01592890|"~     This single-center, open-label study will assess the excretion balance, pharmacokinetics and~     metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive~     a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of~     [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time~     on study is up to 15 weeks.~   "
111804|NCT01592877|"~     To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate~     and heart rate monitor, ICU bedside monitor is used as the gold standard.~   "
111808|NCT01592825|"~     The improvement of the healing rates for breast cancer is based to an important part on the~     consistent use of so-called adjuvant (supporting ) medicamentous therapies, including~     chemotherapy. However this success has a price due to still inaccurate knowledge of the~     individual risk of relapse: a high number of unnecessary therapies are applied~     (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and~     PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors~     with high clinical relevance for patients with node negative breast cancer. Compared to~     clinical and pathological factors (further: traditional factors ) they show better~     estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy~     and may thus essentially contribute to the improvement of the quality of life in these~     women. In this study we aim to evaluate, how large the portion of the patients with early,~     operable, node negative breast cancer will be, in whom, by improved low-risk identification~     through uPA/PAI-1, adjuvant chemotherapy can be omitted.~   "
111809|NCT01592812|"~     Stimulation of arterial inflow to the lower limb is important to obtain functional~     improvement in peripheral artery diseased (PAD) patients with claudication. The clinical~     effect of muscle stimulation to increase arterial inflow and the direct evaluation of the~     regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in~     PAD patients.~      Fifteen adult patients with stable arterial claudication will participate. Recruitment will~     be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope)~     After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an~     increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most~     symptomatic side.~      The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the~     femoral artery, and near infra-red spectrometry (NIRS) on both sides.~      Patients will be instructed to report eventual contraction-induced pain in the stimulated~     calf.~   "
111810|NCT01592799|"~     This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed~     influenza, and compare the clinical features, severity, complications, risk factors and~     socioeconomic impact of influenza in children presenting with acute respiratory illness~     (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.~   "
111811|NCT01592786|"~     The purpose of this study is to evaluate the safety and tolerability of memantine in~     pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive~     Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for~     participation in a follow-up randomized withdrawal study.~   "
111812|NCT01592773|"~     The objective of this study is to evaluate the long-term safety and tolerability of~     memantine in the treatment of pediatric patients with autism, Asperger's Disorder or~     Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).~   "
111813|NCT01592760|"~     The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the~     air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube~     that sits above the vocal cords that does not require inflation of a cuff with air. The~     purpose of this study is to compare the ability of the aILA-SP to maintain patency of a~     patient's airway during general anesthesia with that of the aILA and i-gel devices. As a~     measure of this ability, we hypothesized that the airway sealing pressures will be equal~     between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel~     will be lower).~   "
111814|NCT01592747|"~     This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled,~     randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or~     Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to~     evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.~   "
111815|NCT01592734|"~     The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of~     a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal~     impaction and in the treatment of chronic constipation~   "
111816|NCT01592721|"~     The incorporation of novel targeted therapies to radiation therapy is of particular interest~     in head and neck cancer and may improve efficacy without significantly increasing toxicity.~     The investigators hypothesize that the addition of a second EGFR-targeted agent that~     inhibits EGFR at the intracellular level will improve the antitumor effect of standard~     radiation and cetuximab. The goal of this study is to evaluate the safety, efficacy, and the~     biologic effects in patients with locally advanced SCCHN of an antisense gene targeting the~     EGFR in combination with standard therapy with radiation and cetuximab.~   "
111817|NCT01592708|"~     The purpose of this study is to determine whether a multi-modal anesthesia and pain control~     protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in~     patients undergoing upper jaw corrective surgery.~   "
111818|NCT01592695|"~     The proposed work is designed to help increase access to tobacco cessation services among~     rural veterans and to develop more effective treatment services that better address comorbid~     issues commonly experienced by rural smokers. The objectives are:~        1. Study the feasibility of an individually-tailored telephone intervention for rural~          smokers.~        2. Examine the impact of the intervention on tobacco use outcomes.~        3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers~          including depressive symptoms, alcohol use, and weight gain.~   "
111819|NCT01592682|"~     This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a~     smoke-free educational intervention or self-help control group. The smokefree educational~     intervention includes group education about smokefree environments and smoking cessation,~     follow-up phone calls, and tobacco exposure lab reports. The control group is referred to~     usual care with local in-language smoking cessation classes or quitline, and is otherwise~     assessment only. The investigators hypothesize that pairs in the intervention group will~     have higher rates of tobacco cessation and elimination of smoke exposure, compared to the~     control group.~   "
111841|NCT01592383|"~     The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people~     with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer.~     Erlotinib has been approved by the United States Food and Drug Administration (FDA) for~     other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma.~     This research is being done because there is no current standard treatment for malignant~     peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant~     peritoneal mesothelioma.~   "
111820|NCT01592669|"~     Background:~      The pneumatic tourniquet is frequently used in total knee arthroplasty. Tourniquet deflation~     may result in hypotension and tachycardia caused by the rapid shift of blood volume back to~     the ischemic limb and a decrease in cardiac preload. Passive leg raising (PLR) represents a~     self-volume challenge that can result in an increase in preload. Such a PLR-induced~     increase in preload was hypothesized to attenuate the decrease in preload resulting from~     tourniquet deflation. This study was designed to evaluate the effect of PLR on hypotension~     and tachycardia following tourniquet deflation.~      Methods:~      Seventy patients who underwent unilateral total knee arthroplasty were assigned to either~     the bilateral PLR group (n = 35) or the control group (n = 35), in a prospective randomized~     trial. The patients' blood pressure and heart rate were measured before, during, and after~     tourniquet deflation.~   "
111821|NCT01592656|"~     In this multicenter study the comparison of the mass flow distribution and redistribution~     versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q)~     matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will~     be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore~     a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with~     non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The~     CT-scan will be used for FRI.~   "
111822|NCT01592643|"~     The purpose of this research is to determine if an investigational thin shield over the~     cornea can safely and effectively reduce or eliminate pain following Post Photorefractive~     Keratectomy (PRK).~      The thin shield is made of silicone. The materials used to make the corneal shield all have~     a history of use in medical devices, contact lenses, and/or corneal shields and have been~     used safely in the eye.~   "
111823|NCT01592630|"~     The control of postoperative pain has become a major issue in surgery awareness and it is~     considered an important measurement of patient satisfaction. Improvements in pain relief,~     including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to~     the surgical patient. When pain is aggressively addressed, patients respond by recovering~     faster.~      The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting~     local anesthetic wound infiltration has been widely recognized as a useful adjunct to~     multimodal postoperative pain management. On that basis, a system that delivers a continuous~     local anesthetic to the surgical wound was developed, and better pain control has been~     achieved after several surgical procedures.~      In patients undergoing abdominal procedures, such as colon resection, adequate pain control~     remains an issue. It is known that innervation to the antero-lateral abdomen is provided by~     sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the~     transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been~     described and has shown to be effective for immediate postoperative pain control.~      Recently, the use of the On-Q pain relief system with catheters placed within the TAP has~     been evaluated. Published results have shown significant improvement of pain control~     (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more~     coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of~     prospective trials investigating the effectiveness of a continuous wound infusion with local~     anesthetics after general surgery procedures the investigators sought to determine the~     efficacy of this technique after laparoscopic colon resection procedures.~   "
111824|NCT01592617|"~     The investigators identified three cancer-testis antigens, as targets for cancer vaccination~     against lung cancer. In this clinical study, the investigators examine using a combination~     of three peptides from these three antigens (S-488410) the safety, immunogenicity, and~     antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.~   "
111825|NCT01592604|"~     Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common~     fractures in the foot, frequently treated in fracture clinics and involving significant~     resources. At present methods of treatment and follow up vary widely from no active~     treatment to surgery, depending entirely on a treating doctor preference. There is no~     agreement on simple, safe and reliable method of treatment. The investigators believe that~     vast majority of these injuries heal well on its own without any specific treatment. By~     comparing two most commonly used treatments the investigators aim to establish one simple,~     safe and reliable mode of treatments. The investigators are going to evaluate functional~     results of these two treatments in a short and longer time prospective, by using the best~     available scientific tools. The investigators believe that results of the investigators~     study will eventually lead to change of practise and more efficient NHS care for these~     patients. It will reduce unnecessary treatments and clinic appointments, and bring~     substantial savings to the NHS in a long prospective.~   "
111826|NCT01592578|"~     The purpose of this study is to evaluate the efficacy of two different endoscopic treatment~     in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus~     sclerotherapy in addition to cyanoacrylates~   "
111827|NCT01592565|"~     This study is being done to demonstrate a powerful new method for detecting heart disease~     that combines the proven prognostic capability of exercise stress testing with the superior~     image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to~     demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to~     exercise stress SPECT for detecting obstructive artery disease.~   "
111828|NCT01592552|"~     The purpose of this research project is to collect and store blood samples and clinical~     data. Researchers can then use the stored samples in future studies. Through such studies,~     they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.~   "
111829|NCT01592539|"~     The effects of high serum glucose on bone could be direct or could be indirect through its~     effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have~     found significant differences in skin blood flow between diabetics and control. The~     investigators are proposing that blood flow measurements of the skin may be correlated with~     bone remodeling rates in iliac bone biopsies.~   "
111842|NCT01592370|"~     The purpose of this study is to determine the side effects of treatment with Nivolumab by~     itself or in combination in patients with relapsed/ refractory lymphoma or multiple myeloma.~   "
113467|NCT01570985|"~     This is a study on the treatment of frozen shoulder with injection of cortisone into the~     shoulder joint. The purpose of the study is to evaluate whether injection with stretching of~     the shoulder capsule or plain injection is more effective than no specific treatment.~   "
111830|NCT01592526|"~     Critical illness, severe infection, extensive trauma or tissue damage cause an inflammatory~     (irritative) reaction in the body. This reaction affects the whole body and causes malaise,~     circulatory and cardiac changes, fever, increases the number of white blood cells in the~     blood stream and prompts release of signaling proteins. This reaction contributes to the~     development of considerable organ damage and possibly organ failure. These are serious~     complications in critical illness which are associated with a high mortality. This~     inflammatory reaction is affected by the autonomic nervous system. This is the part of the~     nervous system, which is beyond the control of the free will, and the part that regulates~     circulation, breathing and digestive functions. The autonomic nervous system works via~     so-called sympathetic signals, which set the body in a state of alertness to overcome~     immediate challenges, and parasympathetic (vagal) signals, which are especially active~     during restitution and rest. It is known, that the balanced activity in the autonomic~     nervous system affects the body's inflammatory response in critical illness. A study in mice~     has shown that if parasympathetic (vagal) signals are blocked mortality in critical illness~     is increased. Reversely, when the autonomic nervous system is medically stimulated towards~     parasympathetic signaling, the magnitude of the inflammatory response is decreased. Nicotine~     exerts this stimulatory effect.~      Also, we know that individuals in good physical shape have increased parasympathetic tone~     compared to less trained individuals. However, studies have never addressed whether this~     shifted balance in the autonomic nervous system affects the inflammatory response related to~     critical illness.~      Over the last 30 years an experimental model mimicking the inflammatory response has been~     used in studies. Inflammation may be simulated by injecting the drug E.Coli LPS, which~     induces a controlled, fully reversible, harmless reaction the duration of which is a few~     hours. Influenza-like symptoms occur and changes in circulatory parameters and~     concentrations of signaling proteins can be measured.~      Using this experimental model, the investigators wish to study whether this shifted balance~     in the autonomic nervous system in individuals in good physical shape affects the body's~     reaction to critical illness. Investigators also want to determine how nicotine (using a~     nicotine patch) affects this reaction.~   "
111831|NCT01592513|"~     In this research, the investigators will asses the effect of BIS monitoring on propofol~     usage during elective flexible fiberoptic bronchoscopy.~      The investigators will examine whether use of BIS monitor enables reduction of sedative dose~     during bronchoscopy.~      The investigators will also examine whether administration of lower total sedative dose~     enables prevention of possible complications.~   "
111832|NCT01592500|"~     This is a phase II, open label, active-controlled, randomized safety and dose finding study~     of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth~     hormone deficient children.~   "
111833|NCT01592487|"~     This study is designed to test how breakfast affects brain function, memory and learning in~     healthy children.~      Hypotheses: Based on the results of our initial study and the relevant literature, it is~     hypothesized that arousal, attention, and performance will be:~        1. Greater in those who eat breakfast relative to those who do not;~        2. Greater in lean than in overweight children receiving the higher protein breakfast;~        3. Greater in fasting lean than fasting overweight children; and~        4. Improved following a morning snack in all study groups.~        5. Poorer in children with higher stress-related measures (e.g., higher cortisol levels).~        6. Heart rate will be lower in fasting relative to fed participants, and across groups~          will be higher in overweight children.~   "
111834|NCT01592474|"~     The purpose of this study is~        -  To examine if Avaonex can delay the development of clinically definite multiple~          sclerosis.~        -  To investigate if Avonex can delay disability progression by slowing brain atrophy.~   "
111835|NCT01592461|"~     The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269)~     about 2 to 5 years since they were originally recruited from 8 substance abuse treatment~     clinics (located in 5 states) to participate in a prior clinical trial study called START~     (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be~     conducted over 5 years and will involve three follow-up interviews with START participants.~      The specific aims of the START Follow-up Study are as follows.~        1. To determine longer-term outcomes of Suboxone versus methadone treatment received in~          the START~        2. To investigate patient and treatment factors associated with post-START treatment~          access, utilization, and outcomes among Suboxone and methadone patients~        3. To explore other correlates of the long-term outcomes among START patients.~   "
111836|NCT01592448|"~     The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews,~     the efficacy of 'enhanced' acetaminophen messages and icons in improving consumer~     understanding and use of prescription (Rx) and non-prescription (over-the-counter, OTC)~     acetaminophen containing products compared to the current standard.~   "
111837|NCT01592435|"~     The study objective is to acquire composite images generated by the Carestream Long Length~     Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI~     software and the images stitched using a approved predicate device are acceptable for~     clinical use.~   "
111838|NCT01592422|"~     The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not~     been confirmed. Many treatment modalities like chemotherapy, interferons and other~     biological agents have been tested as maintenance therapy in SCLC, but the results are~     disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and~     interferon-alpha, however, the functioning status and immune system may get worse, which~     subsequently has a negative impact on patient's quality-of-life. Immunotherapy with~     autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism~     through stimulating immune response and altering the interaction between tumor and its host.~     This effect may result in improved tumor control and survival, as well as a better quality~     of life. To test the hypothesis, a randomized controlled study was conducted to compare CIK~     cells with best supportive care as maintenance therapy for SCLC.~   "
111839|NCT01592409|"~     Motor vehicle collisions are the leading cause of death for young people. The investigators~     have recently found that driving after using cannabis is more common among young Canadian~     drivers than driving after drinking. While this observation raises concerns, the effects of~     cannabis on driving-related skills in this age group are not well understood. As well,~     evidence suggests that residual effects of cannabis on driving-related skills may be~     observed up to 24 hours later. These residual effects may have important implications for~     the effects of cannabis use on collision risk, but little evidence on them in available.~     This study will examine the effects of a single dose of cannabis (marijuana) on~     driving-related skills immediately following consumption, 24 hours later, and 48 hours~     later. To date, the residual effect at 48 hours has not been examined. A total of 142~     subjects aged 19 to 25 years old will be randomly assigned to smoke either a placebo or~     active cannabis cigarette (12.5% THC potency). Following an eligibility screening and~     practice session, participants will attend 3 testing days; drug-administration, 24-hour~     follow-up and 48-hour follow-up. The effects of cannabis/placebo on performance of~     driving-related skills using a high-fidelity driving simulator will be assessed on each~     testing day. The effects of cannabis on mood, cognition, memory and complex reaction time~     will also be assessed. Identifying factors that affect the collision risks experienced by~     young drivers is a public health priority. While many young people believe that cannabis~     does not impair driving, some recent studies suggest that these may be very dangerous~     beliefs. This study will provide important information on how cannabis may affect the~     driving skills of young drivers, to inform efforts to understand and address~     cannabis-related collision in this age group.~   "
111840|NCT01592396|"~     The pharmacokinetic (PK) profile of tralokinumab (CAT‐354) will be studied in adolescent~     subjects with asthma.~   "
113666|NCT01568398|"~     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD),~     in participants with a history of gastric or duodenal ulcer requiring long-term low-dose~     aspirin therapy will be investigated.~   "
111843|NCT01592357|"~     Cardiac exercise rehabilitation consists of walking and bicycling activities. As the~     population requiring rehabilitation is aging, other forms of exercise may be useful and~     better tolerated. Tai Chi has been used for centuries, is easy to perform even by more~     debilitated individuals, and promotes improvement in blood pressure, fitness, and~     relaxation. Tai Chi may be more beneficial for frail cardiac patients because it is~     especially suited for the unfit and elderly, and can be practiced anywhere. Further studies~     are required to assess this form of exercise in cardiac patients. The objective of this~     randomized controlled study is to compare the effects of Tai Chi to sham exercise training~     in 200 frail cardiac patients who have completed six months of cardiac rehabilitation and~     are 60 years of age or older. Participants will be randomized to Tai Chi or sham exercise~     training and have their gait speed, blood pressure, heart rate, exercise capacity, balance,~     quality of life and cognitive function assessed before and after 24 week of training.~   "
111844|NCT01592344|"~     The purpose of this study is to investigate whether the StimRouter (SR) electrical~     stimulation therapy leads to clinically important pain relief in patients with chronic~     intractable pain of peripheral nerve origin after three months of treatment. At the same~     time, this study will gather information on side effects associated with the StimRouter~     electrical stimulation therapy.~   "
111845|NCT01592331|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.~      Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or~     placebo. In-unit period is 6 days.~   "
111846|NCT01592318|"~     This randomized, open-label, crossover study will evaluate the relative bioavailability of~     ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc~     combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects~     will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an~     FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a~     crossover design, subjects will participate in 3 study periods with at least a 7-day washout~     between periods. In Part 2, single dose administration of film-coated FDCs will be compared~     to reference tablets.~   "
111847|NCT01592305|"~     This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study~     will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered~     with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in~     healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral~     doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2,~     all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study~     treatment is up to 20 days.~   "
111848|NCT01592292|"~     This prospective, multi-center, observational study will evaluate the efficacy and the~     safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not~     responded or have been intolerant to a first anti-TNF alpha therapy. Participants have~     commenced MabThera or an alternative anti-TNF alpha treatment as a second biological~     therapy. Data will be collected for 12 months.~   "
111849|NCT01592279|"~     The new incretin-based therapies offer appealing advantages over existing drugs. Aside from~     glucose dependent insulin secretion and a proven glucose lowering efficacy, they have other~     concomitant beneficial effects, such as low risk of hypoglycemia, inhibition of the glucagon~     secretion with maintenance of counter-regulatory mechanism, promotion of weight loss, and~     possible cardiovascular benefits (improvement of lipid profile, blood pressure, endothelial~     and myocardial function). The glucose lowering effects resulting from the inhibition of~     glucagon secretion and the gastric emptying rate could be of clinical importance in type 1~     diabetes.~      The rationale behind the use of GLP-1 analogues in the treatment of type 1 diabetes relies~     on the assumption that these drugs, in addition to their action on insulin secretion and~     glucose regulation, may be effective in preserving and even expanding the β-cell mass. This~     class of drugs may represent an entirely new approach to the treatment of type 1 diabetes,~     focused on protection and preservation of β-cells. These therapies have the opportunity to~     interfere with the disease progression if used as an early intervention, when enough β-cell~     mass/ function can still be preserved or restored.~      Hypothesis:~      GLP-1 analogue (liraglutide) will improve glycemic control as measured by HbA1c in~     uncontrolled type 1 diabetic patients. The investigators expect a reduction of 1% in HbA1C~     from baseline.~   "
111850|NCT01592266|"~     PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a~     precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution.~     Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic~     disease either in bone marrow or extramedullary.~      F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as~     well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive~     study can replace bone marrow biopsy and predict response vs. non response to therapy.~   "
111851|NCT01592253|"~     For patients who meet the inclusion criteria and who agree to participate in this study, the~     investigators sampled peripheral blood 10cc and performed the analysis for immunologic~     profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year~     from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha~     analysis fo immune profile again. During the study period, the interval of the visit of~     subclinic and the kinds of laboratory test (Blood and urine test) would not change compared~     to before the start of this study.~   "
111852|NCT01592240|"~     To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615~     administered subcutaneously at monthly intervals, or twice monthly intervals in subjects~     with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a~     statin.~   "
111853|NCT01592227|"~     A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and~     an adjuvant from two different paracetamol formulations.~   "
111869|NCT01592019|"~     The investigators hypothesize that a technique called microdialysis can be used to measure~     the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin.~     Microdialysis uses a small device called a 'probe' to determine the amount of drug which~     enters a body tissue. The small device is placed directly in the fatty tissue and samples~     are taken at specific times. The investigators will determine whether site of application~     affects the availability of the drug.~   "
111854|NCT01592214|"~     This is a Phase I, multi-center, clinical study of XF-73 to evaluate the local (nasal)~     safety and tolerability of a modified, thinner lower viscosity formulation of intranasal~     XF-73 in healthy male and female subjects. In addition, the potential for systemic~     absorption of XF-73 in the modified, thinner lower viscosity and the previously investigated~     thicker, higher viscosity formulations and their decolonization efficacy in comparison to~     placebo will be evaluated. Both parts of the study will be double-blinded and Part 2 will~     also be placebo-controlled. Primary objective is to establish the safety and tolerability of~     two concentrations of a modified thinner, lower viscosity nasal formulation of XF-73 and to~     compare them to a previously investigated, thicker, higher viscosity formulation~   "
111855|NCT01592201|"~     The purpose of this study is to compare the patient satisfaction between continued~     administration of previous antipsychotics versus switched administration to paliperidone ER~     in non-satisfied patients with previous (paliperidone)~   "
111856|NCT01592188|"~     This project will explore the effect of Cognitively-Based Compassion Training or mindfulness~     training on behavior and saliva stress hormones in elementary school-age children.~   "
111857|NCT01592175|"~     The tight relationship between attention and conscious perception makes them difficult to~     study in isolation and has led many scientists to closely link these two processes. However,~     while some authors argue that conscious perception cannot occurs without attention,~     magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are~     two distinct brain processes.~      If endogenously triggered attention and consciousness are dissociated, it has been proposed~     that orienting of exogenous attention is a necessary, though not sufficient, antecedent of~     conscious perception.~      In the present study we used MEG to explore the neural correlates of exogenous attention and~     consciousness during visual processing.~   "
111858|NCT01592162|"~     The objective of this study is to evaluate the influence of different propofol formulations~     (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is~     administered using a closed-loop algorithm in order to reach a Bispectral Index target of~     50.~   "
111859|NCT01592149|"~     The study is an epidemiological survey to find out the incidence of loss of appetite in~     Indian patients suffering from various health disorders. This survey will be conducted to~     obtain information on appetite from a total of 17500 subjects This study does not intend to~     study the effect of any drugs. The primary source of information will be the subjects~     themselves. The study will be conducted at 275 - 350 centres spread across India.This is a~     single visit study.The physician will conduct routine clinical, physical and general~     examination.~   "
111860|NCT01592136|"~     This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic~     myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic~     leukemia (Ph+ALL) who have failed all available treatment options.~   "
111861|NCT01592123|"~     The aim of this report was to assess the frequency of poor sleep quality, daytime and dream~     anxiety and their response to subsequent surgical treatment for a representative group~     patients with nasal septum deviation.~   "
111862|NCT01592110|"~     This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of~     three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro~     Needle-Free Delivery System in patients with chronic, stable schizophrenia.~   "
111863|NCT01592097|"~     Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its~     clinical effect in the Hispanics with MS given that clinical studies had limited~     representation of this population. It is also unclear if Gilenya would be as effective in~     individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS)~     commonly seen in Asian populations.~      Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting~     OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response~     and clinical disease state.~   "
111864|NCT01592084|"~     The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis~     (ALS) pathophysiology and its impact on disease progression and survival is unclear. The~     investigators analyzed the correlation between lipid levels with disease progression and~     survival in ALS patients and the association of LLT with these outcomes.~   "
111865|NCT01592071|"~     This study assessed the effect of an IgG-mediated food sensitivity test in combination with~     a food elimination diet on body composition and secondary outcomes in people who were~     overweight.~   "
111866|NCT01592058|"~     The purpose of this study is to learn whether women who use progestin-only methods of birth~     control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS~     (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared~     to women using the non-hormonal copper IUC (ParaGard).~      The investigators primary hypothesis is that users of DMPA will gain excess weight and~     increase their BMI above the copper-IUC users; secondarily, the investigators will compare~     users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.~   "
111867|NCT01592045|"~     The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of~     chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC]~     or the National Cancer Institute [NCI]).~   "
111868|NCT01592032|"~     The antibiotic lock technique (ALT) is used as local treatment for Catheter-Related~     Bacteremia (CRB). It consists in the administration of a concentrated antimicrobial solution~     with a calculated volume to fill the lumen of the catheter. The lock solution is indwelled~     within the catheter for a defined period of hours or days before been removed.~      Currently, the Infectious Diseases Society of America (IDSA) Guidelines for treatment and~     management of CRB, recommends to change the antibiotic solution every 24 hours.~      The investigators expect to determine the stability of the concentration of vancomycin,~     teicoplanin, linezolid, daptomycin and tigecycline used in lock solutions, and thus to assay~     the optimal timeframe that the concentration of antibiotic used in lock solution keeps its~     in vivo antimicrobial activity.~      Study Hypothesis: An antibiotic lock solution maintains in vivo concentration and~     antimicrobial activity for at least 10 days after its infusion inside a subcutaneous port~     catheter.~   "
111881|NCT01591863|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
111870|NCT01592006|"~     Patients are being asked to be part of this study because they are a liver transplant~     recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver~     transplant patients includes taking two medications called pegylated interferon alfa-2a~     (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment~     of HCV.~      This study will evaluate the safety and efficacy of adding a third drug called telaprevir~     for the experimental treatment of HCV in liver transplant patients. The combination of~     Pegasys, ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is~     specifically not FDA approved for HCV patients who have had a liver transplant. This is~     because more information is needed about possible drug interactions between telaprevir and~     cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are~     typically part of routine care for transplant patients.~      Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys~     and ribavirin for the treatment of HCV. However, these studies did not include adequate~     information on transplant patients due to the potential drug interactions.~      The investigators hope to gather more information about the safety and efficacy of~     telaprevir given in combination with Pegasys and ribavirin in the liver transplant patients~     who have HCV that is not well controlled with Pegasys and ribavirin alone.~   "
111871|NCT01591993|"~     Sensitive skin syndrome is a frequent self-diagnosed entity that has not been previously~     described in a Latin-american population. One hypothesis to its development is an alteration~     of the barrier function of the skin. The aim of the study is to describe the frequency of~     sensitive skin in a mexican population detected through the lactic acid test, and to explore~     its response through biophysical measures (colorimetry, transepidermal water loss (TEWL) and~     capacitance). The prevalence of this syndrome in studied populations is approximately 50%.~     Considering racial skin differences, the investigators would expect at least a 20%~     prevalence.~      For this purpose, the investigators would need a minimum of 243 healthy volunteers, 18 years~     or older, with previous informed consent, to whom the lactic acid test will be performed.~     The investigators will record any unpleasant sensation graded in a Visual Analog Scale (VAS)~     of 10 points, colorimetry, TEWL and capacitance before the test and at 3, 5, 8 and 10~     minutes after the lactic acid test.~   "
111872|NCT01591980|"~     Objective: To compare the incidence of chronic pain at 3 months among adults undergoing~     craniotomy between those received two different doses of pregabalin and those receiving~     placebo.~   "
111873|NCT01591967|"~     The purpose of this randomized controlled trial (RCT) is to measure the effects of specific~     thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both~     normotensive and hypertensive humans.~   "
111874|NCT01591954|"~     Current standard of care for complex head, neck and skull base surgery require navigation~     systems that allow instruments to be tracked optically or electromagnetically while~     registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance~     image (MRI). However, conventionally, the CT/MRI data is not registered with video~     endoscopy. Augmentation of endoscopic video by preoperative data can facilitate navigation~     around critical structures and robust target resection. The work presented here describes~     evaluation of a high definition (HD) video-overlay system for endonasal endoscopic skull~     base surgery. We adopt a modular design that can be extended for other video augmentation~     applications. The system supports fast automatic camera calibration, comparable in~     re-projection errors to standard camera calibration tools, while performing within~     appropriate run time for clinical use. Phantom studies have shown the registration accuracy~     of the system to be equivalent to that of conventional optical tracking. With this system we~     are proposing a clinical pilot study in a small number of patients at Johns Hopkins Hospital~     to evaluate basic feasibility and to gather qualitative assessment of the video augmentation~     system.~   "
111875|NCT01591941|"~     There is a large number of young women who sustain serious knee injuries from playing~     soccer. Female athletes are at high risk of knee injuries from soccer than males. We will~     conduct a research project to assess the effect of a warm-up on changing some of the~     movement patterns thought to contribute to these serious knee injuries.~      It is hypothesized that a core position and control movement strategy (Core-PAC) group~     reduce biomechanical risk factors at the knee compared to a control after the training~     program.~   "
111876|NCT01591928|"~     Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along~     the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly~     associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA).~     Advances in cardiac surgery have improved HS mortality such that there is increasing~     attention to IRA and their management. The objective of this research project is to~     prospectively observe a cohort of infants with HS and IRA and evaluate their long term~     outcomes. Specifically, the investigators would like to determine what is the natural~     history of asymptomatic IRA in patients with HS and what is the morbidity and mortality~     secondary to an elective Ladd procedure for asymptomatic IRA in a population with HS? The~     investigators plan a prospective, multi-center, observational study to follow this~     complicated group of patients. This will be a web-based database collected from major~     cardiac tertiary care centers in both Canada and the United States. Patients with HS will be~     recruited by their primary site and clinical data will be collected by their primary site~     prospectively throughout childhood until they are at least five years of age. This patient~     population will be followed by their own clinical care givers; this is not an interventional~     study. No additional clinic visits will be required and the patients will not have to be~     contacted. Patient medical records will be accessed by a member of the study team at the~     primary site at least once per year or more frequently if interventions are required or~     complications develop.~   "
111877|NCT01591915|"~     The purpose of this study is to evaluate the effect of mindfulness based stress reduction~     intervention in women with breast cancer~   "
111878|NCT01591902|"~     To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of~     Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and~     Type 2 diabetes mellitus (T2DM).~   "
111879|NCT01591889|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Tinidazole 500 mg Tablet under fed conditions.~   "
111880|NCT01591876|"~     The aim of this study is to evaluate whether a three month intra-dialytic exercise programme~     improves arterial function.~   "
111882|NCT01591850|"~     This randomized, single-center, open-label, one-sequence, two-period crossover study in~     three parts will assess the effects of multiple doses of ketoconazole, rifampicin and~     ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in~     healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of~     RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple~     oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated~     time on study is up to 8.5 weeks.~   "
111883|NCT01591837|"~     This is a study to assess the immune (antibody) response and safety of the 2012/2013~     formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or~     older.~   "
111884|NCT01591824|"~     Through this research is to conduct a pilot clinical trial in the treatment of chronic~     nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that~     will apply a technique of physiotherapy by passive movement of the column with oscillations~     in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called Pold~     Concept), another group that applies the standard protocol of treatment for this condition,~     as used in the hospital where performed the study.~      It will compare the levels of efficiency and effectiveness of each treatment and the~     comparison between them. This will measure the perception of pain intensity and disability.~   "
111885|NCT01591811|"~     1. To test the hypothesis that when prone, patients treated with 3D-CRT breast~          radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed~          develop acute toxicity that is not significantly worse than that of a concurrent cohort~          of patients treated with IMRT randomly assigned to a weekly or daily boost regimen.~        2. To test the hypothesis that when prone, patients treated with 3D-CRT breast~          radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed~          develop late toxicity that is not significantly worse than that of concurrent cohort of~          patients treated with IMRT randomly assigned to a weekly of daily boost.~        3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be~          achieved in each of the two randomized arms, for either technique tested.~   "
111886|NCT01591798|"~     After introducing minimally invasive surgery, robotic surgery has been increasingly used in~     colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of~     this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low~     rectal cancer.~   "
111887|NCT01591785|"~     Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In~     adults, eczema commonly localizes to the hands or feet. Several studies have implicated~     bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor~     in atopic dermatitis, as infection with this bacteria correlates with disease severity. No~     trial to date has investigated how to treat S. aureus infection in adults with hand or~     hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet,~     the investigators expect to have a significant clearance rate of s. aureus infection. The~     investigators believe that treating the bacterial infection along with treating the~     condition with a topical corticosteroid will significantly decrease the severity of~     hand/foot dermatitis in our study population.~   "
111888|NCT01591772|"~     The purpose of this study is to learn about possible changes in brain anatomy and function,~     and in thinking abilities, such as memory skills, in patients with ovarian cancer who~     receive treatment with chemotherapy. Cancer patients treated with chemotherapy may~     experience changes in thinking abilities, and these may interfere with quality of life. Most~     of the research to date has involved patients with breast cancer, and there are no studies~     in women with ovarian cancer looking at at treatment-related changes in brain anatomy and~     function.~   "
111889|NCT01591759|"~     This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive~     function, clinical state and substance use in 40 individuals with mild traumatic brain~     injury (mTBI).~   "
111890|NCT01591746|"~     Each year, the number of breast cancer survivors who choose post-mastectomy breast~     reconstruction keeps rising. Among women who elect to pursue breast reconstruction,~     approximately 75% will choose prosthetic breast reconstruction. Implant-based breast~     reconstruction is frequently achieved in two-stages. The first stage consists of the~     placement of a tissue expander after mastectomy. This is followed by a period of biweekly~     tissue expansions that can last several months. In the second stage, the tissue expander is~     removed in a surgical procedure and replaced with a permanent breast implant. Tissue~     expansion is a well-established breast reconstruction technique characterized by high~     success rates and high patient satisfaction. Despite the well-recognized advantages of this~     successful breast reconstruction technique, the subpectoral placement of a tissue expander~     is associated with significant pain and discomfort in the immediate post-operative period~     and during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently~     reported problem during tissue expansion. Legeby et al. recently showed that women who~     underwent prosthetic breast reconstruction had higher pain scores and took more analgesics~     that those who did not choose post-mastectomy reconstruction.~      In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of~     clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by~     Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has~     both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought~     to be related to its effects on muscular contraction. However, a recent in vitro study of~     embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a~     neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic~     properties of BTX-A is increasingly supported by several clinical observations: pain relief~     with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic~     tennis elbow, and post-operative pain control for lower limb lengthening correction, among~     others.~      This aspect has never been studied in breast cancer survivors who elect to pursue breast~     reconstruction with tissue expanders. Furthermore, physical function outcomes are important~     to consider with BTX-A use because the link between temporary muscle paralysis and~     improvements in participation in daily activities is not a given.~      The investigators propose to complete a double-blinded prospective randomized controlled~     trial of women undergoing unilateral and bilateral mastectomies with immediate placement of~     tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in~     improving physical well-being during the expansion period.~   "
111904|NCT01591564|"~     The purpose of this study is to determine the feasibility and acceptability of an utilizing~     an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for~     Depressed Adolescents, for youth with severe mood dysregulation (SMD).~      The investigators hypothesize that retention rates will be >80%,satisfaction scores will~     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD~     intervention will have overall improvement in SMD symptoms.~   "
111905|NCT01591551|"~     The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep~     efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients~     receiving Natalizumab for 6 months relative to baseline.~   "
111906|NCT01591538|"~     Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative~     bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6~     months outside France.~   "
111891|NCT01591733|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.~     Investigational means that the therapy is still being studied and that research doctors~     are trying to find out more about it-such as the safest dose to use, the side effects it may~     cause, and if therapy is effective for treating different types of cancer. Proton beam~     radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery~     system.~      Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as~     it delivers less radiation beyond the area of the target tissues. This may reduce side~     effects that patients would normally experience with standard (photon) radiation therapy,~     which tends to include more normal tissue along with tumor target tissue.~      Researchers in the laboratory have discovered that there are pathways inside the cells that~     can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and~     capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,~     and may result in the tumor shrinking in size.~      In this research study, the investigators are looking to determine if proton beam radiation~     in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of~     your cancer.~   "
111892|NCT01591720|"~     A tailored Internet-based cognitive-behavioural intervention is tested within a primary care~     clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant~     within-group effects are expected.~   "
111893|NCT01591707|"~     The purpose of this study is to test the effectiveness of a school-based treatment aimed at~     increasing language and social skills in preschool-aged children with autism spectrum~     disorder (ASD). Through interactive development (continually seeking educator feedback for~     intervention improvement) and implementation of the intervention, the investigators hope to~     provide a feasible and practical means for educators to work with children with ASD in real~     world, large scale settings. ASD preschool educators, the children enrolled in their~     classes, between the ages of 3 and 6 years and their families may join.~   "
111894|NCT01591694|"~     Trauma-informed treatment will improve emotional regulation and behavior.~   "
111895|NCT01591681|"~     The purpose of this study is to see whether low blood sugar at night can be reduced by using~     a system that turns off the insulin pump automatically. The study system includes a~     combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc~     and a regular laptop computer that runs a computer program that predicts low blood sugar. It~     works by (1) measuring the glucose levels under the skin with a continuous glucose monitor,~     (2) using a computer program on a laptop to predict what will happen to the glucose level~     over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program~     predicts that low blood sugar will occur.~      This study has several phases and will take about 3 months for a patient to complete.~     Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure~     that they are able and willing to use this system and to determine if they meet the~     investigators study criteria to proceed with the next phase of the study. Patients will be~     provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic~     CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is~     able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most~     recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to~     complete the CGM run-in phase will have an extra office visit for training.~      If eligible to continue in the study, patients will need to use the study system for 5~     nights at home so that the investigators can make sure they are able to use it correctly.~     After that, patients will be asked to use the study system each night for an additional 6 to~     8 weeks. If the system is active and predicts that a patient's blood sugar will become low,~     the insulin pump will shut off for up to 2 hours.~      The study will include about 45 individuals at 3 clinical centers in the United States and~     Canada.~   "
111896|NCT01591668|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up~     visits are also required periodically through day 43. Study procedures involve taking blood~     samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.~   "
111897|NCT01591655|"~     The objective of this clinical study is to compare the safety and efficacy of mapracorat~     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation~     and pain following cataract surgery. Participants from the United States and Canada will be~     recruited for this study.~   "
111898|NCT01591642|"~     The main purposes of this study are: (1) to investigate the difference of the physical~     fitness, and quality of life (QOL) among different physical activity levels in post-coronary~     artery bypass graft (CABG) patients; (2) to analyze the relationships between physical~     activity and physical fitness and QOL in this population. The investigators predict physical~     activity and physical fitness remain limited in patients after CABG, and patients with~     higher physical activity levels will have higher QOL and physical fitness.~   "
111899|NCT01591629|"~     The purpose of this project is to examine the effects of mu-opiate antagonism on the~     rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main~     psychoactive ingredient of cannabis.~   "
111900|NCT01591616|"~     To establish Oraqix is safe when used on adolescent volunteers.~   "
111901|NCT01591603|"~     The study will investigate the difference in success rate between popliteal peripheral nerve~     catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.~   "
111902|NCT01591590|"~     The purpose of this study is to assess whether in a population of patients with advanced~     colorectal cancer for which no known effective therapy is available, measuring the~     spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and~     Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that~     serial FDG PET-CT and Diffusion MRI are able to measure it.~   "
111903|NCT01591577|"~     The purpose of this study is to test the safety and effects of a combination of a study~     drug, Lapatinib, plus the administration of standard radiation therapy and an FDA approved~     drug Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma~     Multiforme.Currently, only radiation therapy and Temozolomide chemotherapy are standard~     treatment for brain cancer.Lapatinib has not been FDA approved for use in brain tumors~     treatment. It has been approved to be used as a daily treatment with other chemotherapies by~     the FDA for the treatment of advanced breast cancer.~      The purpose of this study is to find the answers to the following research questions:~        1. Is Lapatinib given twice a week at higher dosages, with radiation therapy and~          Temozolomide, safe when given to patients with brain tumor?~        2. What are the side effects of Lapatinib given twice a week at higher dosages when given~          with radiation therapy and Temozolomide and how often do they occur?~        3. Can Lapatinib, radiation, and Temozolomide be effective in shrinking tumors when given~          to patients with brain tumors?~        4. To determine whether the presence of genetic alterations specific proteins in the tumor~          samples can predict whether this study drug is effective on the tumor.~   "
111907|NCT01591525|"~     The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in~     minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as~     help patients without a regular primary care physician (PCP) find one within their~     community. These goals will be achieved first through a glucose measurement. Individuals~     with a high glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test.~     The HgA1c test will tell us about the patients average blood sugar over the past 3 months,~     which will allow us to immediately diagnose new and uncontrolled type II diabetics. All~     participants will fill out a survey on healthcare seeking behaviors before glucose testing.~     All patients who enter the study will receive education on T2D and the value of regularly~     visiting their PCP, and will be provided a list of PCP currently accepting new patients~     within a 3 mile radius. Follow-up visits at 4 and 8 months will help us determine the~     success this community based screening.~      The investigators hypothesis is that community based screening designed with adequate~     education and follow-up, and performed by qualified medical professionals will improve~     diabetes care in minority communities as assessed through hemoglobin A1c levels over 8~     months, and in the change in the number patients who visit/obtain their PCP within the study~     period.~   "
111908|NCT01591512|"~     The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays~     independently as aids for monitoring the course of disease and therapy in subjects diagnosed~     with SCLC.~   "
111909|NCT01591499|"~     This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare~     the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses~     allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a~     ratio of 1/0.5), in presbyopic patients.~   "
111910|NCT01591486|"~     Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding~     worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs~     (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population [1,2].~     Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases~     is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy~     after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a~     10-fold increased incidence of all-cause mortality compared to those who received continuous~     ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold~     increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer~     bleeding in ASA users is important in reducing morbidity and mortality.~      Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this~     prospective cohort study aims to determine whether testing for Hp will have any impact on~     the long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The~     investigators hypothesize that among ASA users with Hp infection and ulcer bleeding, the~     long-term incidence of recurrent ulcer bleeding with ASA use will be low after eradication~     of Hp alone.~   "
111911|NCT01591473|"~     The purpose of this study is to evaluate FluMist with and without Ampligen in healthy~     volunteers.~   "
111912|NCT01591460|"~     This open-label, multicenter, treatment response guided study will evaluate the sustained~     virological response and safety of the triple combination therapy boceprevir, Pegasys~     (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with~     genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual~     combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination~     therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be~     administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment~     response. The anticipated time on study treatment is up to 48 weeks.~   "
111913|NCT01591447|"~     To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the~     treatment of uncomplicated urogenital gonorrhea.~   "
111914|NCT01591434|"~     Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such~     it is anticipated that through improved exudate management a longer wear time will be~     achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic~     wounds such as venous leg ulcers.~   "
111915|NCT01591421|"~     For the first phase of this study (phase I), the purpose will be to find the dose of a new~     drug, BKM120, that can safely be given in combination with standard dose panitumumab.~      For the second phase of this study (phase II), the purpose is to find out what effects the~     combination of BKM120 and panitumumab, in doses found to be safe in the first part of the~     study, has on patients and their colorectal cancer.~   "
111916|NCT01591408|"~     The proposed study, Placebo-controlled study of EEG biofeedback therapy as an adjunct~     treatment for PTSD, evaluating symptoms and EEG dynamics, will investigate the brain~     dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or~     sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San~     Diego (NMCSD) OASIS program.~      EEG biofeedback treatment protocols for PTSD and other disorders have been developed and~     honed by private practice clinicians over the past 25 years, during which EEG biofeedback~     has become an increasingly popular adjunct therapy.~      The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy~     warrants a clinical study investigating not only symptom reduction, but also the underlying~     neurobiological mechanism. To this end, we propose a study using high density EEG recordings~     before and after treatment for PTSD symptoms to determine which brain activities correlate~     with reported symptom changes.~      The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG~     biofeedback is shown to improve symptom reduction over the placebo controlled condition, it~     would offer a non-pharmacological intervention that would avoid undesirable side effects,~     and accelerate recovery compared with the current standard of care.~   "
111939|NCT01591096|"~     Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and~     dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to~     determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among~     three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset~     of acute AIS.~   "
112178|NCT01587950|"~     A randomized, controlled, double blind exploratory study to explore the effects of two~     different potassium nitrate concentrations and water on exposed dentine in reducing dentinal~     hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by~     visual analogue scale (VAS) scores following evaporative (air) stimulus.~   "
111917|NCT01591395|"~     Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety~     and feasibility of laparoscopy was established and gaining popularity in recent few years.~     Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter~     recovery period, earlier return to normal daily activities and work, and better cosmetic~     results. The laparoscopic hernia repair usually require three working ports ranging from 5~     to 10 mm. However, with each increasing laparoscopic ports usually associated with possible~     increasing morbidity and pain related to ports.~      Efforts are continuing to further reduce the port related morbidities and improve the~     cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of~     ports. This has led to the evolution of a novel surgical approach now collectively known as~     laparoendoscopic single site surgery. LESS has been performed for variable indications~     including extirpative and reconstructive urologic procedure via the transperitoneal~     approach. Early experience has demonstrated the feasibility as well as the safe and~     successful completion of these LESS procedures. Although these initial reports are~     promising, the clinical advantages of LESS procedures over conventional laparoscopic~     procedures have not been defined. Therefore, we conducted a single center, randomized trial~     to compare the safety and other outcomes after conventional laparoscopic and LESS inguinal~     hernia repair in adult patients.~   "
111918|NCT01591382|"~     Patients who are dependent on opioids often have poor pain relief after major surgery. This~     study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of~     intravenous opioids for postoperative pain will improve pain relief in this subset of~     patients.~   "
111919|NCT01591356|"~     The goal of this clinical research study is to learn about the safety of siRNA-EphA2-DOPC~     when given to patients with advanced, recurrent cancer. Researchers also want to learn the~     highest tolerable dose of this drug that can be given.~      siRNA-EphA2-DOPC is designed to shut down the activity of a genetic biomarker called EphA2.~     Biomarkers are found in the blood and tissue and may be related to your reaction to the~     study drug.~      You are being asked to take part in this study because you have advanced cancer that is~     recurrent (has come back).~   "
111920|NCT01591343|"~     Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides~     pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or~     rhinoconjunctivitis with or without asthma.~      Primary variable: number of subjects [%] who experienced at least one immediate or delayed~     systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.~   "
111921|NCT01591330|"~     The study will evaluate the effect of different particle size of LY2140023. The study~     involves four single doses of 80 mg LY2140023 taken as 1 tablet by mouth with a washout~     period of at least 3 days between doses. This study will last approximately 60 days not~     including screening. Screening is required within 30 days prior to study entry.~   "
111922|NCT01591317|"~     The purpose of this study is to investigate how the body processes prasugrel and how~     prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of~     prasugrel will be given. Information on side effects will also be collected.~   "
111923|NCT01591304|"~     This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.~   "
111924|NCT01591291|"~     Heavy drinking can cause serious health, family, and economic problems. Finding treatments~     that are effective in decreasing heavy drinking among alcohol-dependent individuals is,~     therefore, an important scientific and health goal. A novel and important strategy to~     enhance alcoholism treatment efforts uses a personalized medicine approach to optimize~     treatment effects by selecting the right patient therapeutically and potentially with a~     minimum of adverse events, for a specific medication.~      This study will extend findings from a randomized double-blind clinical trial of~     ondansetron, in which the medication was found to reduce drinking among individuals with~     certain genotypes (i.e., forms of DNA, the material that controls the inheritance of~     characteristics). The proposed study will address a number of limitations in the prior work,~     including testing the medication in both European-American and African-American samples.~   "
111925|NCT01591278|"~     The objective of the study is to evaluate and compare, clinically and radiographically,the~     effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human~     primary molars.~   "
111926|NCT01591265|"~     This clinical trial investigates relative benefits (clinical effectiveness and quality of~     life) of two extraction patterns when lower first permanent molars (FPM) are extracted in~     children: the conventional treatment where current guidance is followed and extraction of~     the upper FPM is carried out, compared with the intervention where there is no compensation~     extraction of the upper FPM following extraction of the lower FPM.~      Study objectives: To determine whether compensating extraction of upper FPMs following loss~     of lower FPMs in children is of benefit. The particular benefits being investigated are~     related to the resulting occlusion, patient experience and oral health related quality of~     life. The follow up will extend over a period of 5 years or until the patient is 14 years of~     age - whichever is earlier.~   "
111927|NCT01591252|"~     In a group of HIV-positive patients under observation since their first exposure to ART or~     monitored off of ART, BMD changes over one year will be determined. For each subject, the~     investigators will also determine associations between changes in BMD and 1) ART initiation,~     2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated~     through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a},~     high-sensitivity c-reactive protein {hsCRP}).~      Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of~     ART, after excluding those subjects treated with tenofovir.~      BMD will decrease most significantly in HIV-positive subjects with the highest levels of~     cumulative viremia.~      HIV-positive persons with highest cumulative viremia will have the highest levels of~     inflammation, as measured by pro-inflammatory cytokines.~      Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare~     sample and fracture association with the use of varying ART medications among dual-eligible~     persons in Medicare and Medicaid datasets.~      Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to~     HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest~     duration of ART exposure.~   "
113667|NCT01568385|"~     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD),~     in participants with a history of gastric or duodenal ulcer requiring long-term NSAID~     therapy will be investigated.~   "
111928|NCT01591239|"~     This project is aimed at parents with a teenager who is already starting to use drugs. The~     study will test a new, innovative version of a brief intervention. This program will be home~     based rather than implemented by a counselor in a clinical setting. The stage I activities~     will involve manual development, parent training development, and a small feasibility study;~     Stage II involves an efficacy study. Two samples, 110 families each, will participate in the~     trial. Families will be assigned to either an intervention or control condition. The~     investigators hypothesize that the home-based intervention will be superior to the control~     condition. In addition, the investigators expect response to the intervention by the~     adolescent to be mediated by motivation, cognitions, problem solving, peer drug use,~     parenting skills and parent self-efficacy.~   "
111929|NCT01591226|"~     A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term,~     high-intensity exercise task was shown by several studies. These studies were conducted with~     healthy, able-bodied subjects.~      The aim of the study is to investigate whether caffeine or sodium citrate ingestion could~     enhance performance in spinal cord injured wheelchair athletes. It is a double blind,~     placebo controlled and randomized study.~   "
111930|NCT01591213|"~     -The St. Jude Cancer Education for Children Program was created in 2006 as part of the~     outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research~     Hospital. The curriculum is designed to teach schoolchildren about cancer and dispel common~     misconceptions, inform students about healthy lifestyle choices that can translate to~     reduced cancer risk in adulthood, and to inspire an interest in science and scientific~     careers. In the 2010-2011 school year, researchers examined the impact of the program in~     regard to knowledge.~      It has always been clear that St. Jude personnel are limited to visiting a small number of~     schools in person each year so in 2011, a teacher's kit to the education program was~     created. The kit includes all the lesson plans needed to complete the program without the~     presence of St. Jude staff members. As a result, researchers at St. Jude Children's Research~     Hospital want to test the feasibility of the intervention by schoolteachers, and how this~     mechanism of delivery will affect student knowledge, attitudes, and health behaviors~     associated with cancer and healthy living.~   "
111931|NCT01591200|"~     This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with~     cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in~     various parameters will be observed over 2 years.~   "
111932|NCT01591187|"~     Exposure to secondhand smoke is a leading preventable cause of child morbidity and~     mortality, and the adverse health consequences of secondhand smoke are magnified among~     youngsters with cancer and sickle cell disease. Current methods for measuring secondhand~     smoke exposure (SHSe) rely on retrospective reports over extended time periods that are~     subject to recall errors and systematic inaccuracies in reporting and often do not include~     the youngster as the primary informant. These methods may underestimate the extent of~     cumulative SHSe and are not well suited to capturing exposure over time and across settings~     where young people frequent. More appealing methods that engage youngsters to better monitor~     tobacco smoke in their environment are warranted.~      The study will examine the feasibility of cell phone texting to obtain measures of~     secondhand smoke exposure (SHSe) in children treated for cancer or sickle cell disease~     (SCD).~   "
111933|NCT01591174|"~     The purpose of this research is to see if there are differences between children who have FD~     and children without FD in the ability of the stomach to empty food and/or in ghrelin~     hormone levels before and after eating.~      Chronic abdominal pain is the most common persistent pain condition in children and~     adolescents. One of the most often diagnosed types of abdominal pain is functional dyspepsia~     (FD). FD is abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that~     does not get better by having a bowel movement.~      One possible explanation for having FD is a delay in the emptying of food from the stomach,~     or delayed gastric (stomach) emptying. Failing to empty the stomach quickly enough may~     result in the feeling of being full and cause symptoms of bloating, nausea, vomiting and~     pain. Further, hormonal changes occur before, during, or after eating food that appear to~     impact stomach emptying.~      One of the hormones that changes with meals is called ghrelin. The relationship between~     ghrelin and stomach emptying needs to be explored more in children with FD. Better~     understanding of what causes FD symptoms may help us to improve treatment for this~     condition.~   "
111934|NCT01591161|"~     The objective of this clinical study is to compare the safety and efficacy of mapracorat~     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation~     and pain following cataract surgery.~   "
111935|NCT01591148|"~     This study will determine how morbid obesity affects the distribution and metabolism of the~     drug propofol. The investigators hypothesize that propofol will be distributed and~     metabolized differently in morbidly obese subjects as compared to normal weight subjects.~   "
111936|NCT01591135|"~     The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has~     better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients~     with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited~     into this study.~   "
111937|NCT01591122|"~     The purpose of this study is to demonstrate the safety and effectiveness of abiraterone~     acetate when co-administered with prednisone in patients with chemo-naive metastatic~     castration resistant prostate Cancer (mCRPC).~   "
111938|NCT01591109|"~     Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of~     the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with~     metastatic liver tumors derived from colorectal cancer.~      Background Data: Direct evidence on the reversibility of any change in tumor vascularity~     upon bevacizumab cessation in the clinical setting is lacking.~      Methods: The study included 10 patients who received chemotherapy including bevacizumab,~     experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently~     underwent liver resection. CEUS was performed before and immediately after 4 courses of~     chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34~     antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD).~     As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were~     examined.~   "
113668|NCT01568372|"~     The purpose of this study is to determine if a nurse telephone follow-up to parents of~     children who underwent a removal of their tonsils would be effective in reducing pain~     intensity, complications and resort to other healthcare services~   "
111940|NCT01591083|"~     Patients with comorbidities have an increased risk of ulcer re-bleeding, especially within~     the 14 days after first bleeding event. Three-day high dose esomeprazole infusion can~     prevent peptic ulcer rebleeding after endoscopic therapy. However, the optimal dose of oral~     esomeprazole is uncertain, especially for high risky patients. This study is to test whether~     a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with~     Rockall score ≥ 6. Additionally, the second aim of this prospective study was to identify~     the selection criteria to predict poor fading and residual major stigmata of recent~     hemorrhage (SRH) or early recurrent bleeding after successful endoscopic hemostasis and~     high-dose PPI infusion.~   "
111941|NCT01591070|"~     The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment~     once or twice weekly can keep adult facial SD in remission and reduce the incidence of~     exacerbation.~   "
111942|NCT01591057|"~     This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in~     blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed~     either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly~     assigned). Volunteers will have all their food provided during the study, and will consume~     two meals each weekday at the University. Volunteers will complete diet and lifestyle~     questionnaires at the start and end of the study and will have blood and urine samples~     collected at 0, 2 and 4 weeks.~   "
111943|NCT01591044|"~     The purpose of this study is to determine the safety, efficacy and tolerability of R940343~     in the treatment of mild to moderate asthma.~   "
111944|NCT01591031|"~     Anesthesia induction with sevoflurane is not associated with an increased incidence or~     severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.~   "
111945|NCT01591018|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis~     (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of~     risk of brain infarctions due to the activation of endogenous fibrinolytic system during~     cardiac surgery (CS). 120 patients indicated for CS (CABG or valve replacement) will be~     enrolled into the study in order to demonstrate a twenty-percent risk reduction of number~     and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in~     5% level of significance. Patients will be randomized - subgroup 1 will undergo a~     40-240minute non-diagnostic TCD monitoring during CS, subgroup 2 will undergo interventions~     without TCD monitoring.~      The aim of the project is a concordance with the aim No 1 of the Resort Program of a~     Research and Development: Improvement of quality of life of patients using the modern~     therapeutic methods but with relative small positive effect of quality of life. The aim of~     the project is in concordance with a priority of announced public grant competition:~     Development of the new therapeutic methods of cardiovascular disorders, especially coronary~     heart disease and stroke. Confirmation of our hypothesis that sonothrombolysis is able to~     activate endogenous fibrinolytic system during CS with consecutive reduction of the number~     and volume of brain infarcts, can lead to the increase of the safety of CS in patients. We~     can presume that up to 50% of patients indicated for CS can be treated using these methods~     in the future.~   "
111946|NCT01591005|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis~     (continual transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the~     reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic~     system during carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated~     for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to~     demonstrate a twenty-percent risk reduction of number and volume of brain infarctions~     detected using MRI examination 24 hours after CEA or CS in 5% level of significance.~     Patients will be randomized - subgroup 1 will undergo a 60minute non-diagnostic transcranial~     Doppler (TCD) monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD~     monitoring. The second aim is to compare number of brain infarctions detected using MRI~     between CEA and CS patients.~      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate~     endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and~     volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients~     with internal carotid artery stenosis. The investigators can presume that up to 50% of~     patients indicated for CEA or CS can be treated using these methods in the future.~      In the Substudy Risk of brain infarction after carotid endarterectomy and stenting the the~     risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as~     well as morbidity and mortality at 30 days between patients with symptomatic and~     asymptomatic severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS~     will be compared.~      The sample size of the Substudy was based on an expected 80% difference of new ischemic~     lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study~     calculations showed that a minimum of 73 patients in each group was needed to reach a~     significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8~     assuming that 15% of subjects would be lost to follow-up or refuse to participate in the~     study.~   "
111947|NCT01590992|"~     The purpose of this study is to determine whether psychotherapy (based on exposure~     techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform~     Disorders (as exemplified here in subjects with globus sensations in the throat).~   "
111948|NCT01590979|"~     The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset~     atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient~     population at Staten Island University hospital.~   "
111949|NCT01590966|"~     In this open-label monocentric explorative pilot trial the objective is to show the~     biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active~     rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is~     certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high~     specificity for TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of~     this study is to show the TNFα triggered inflammation process in the inflamed joints,~     especially in patients who have very early joint damage where currently other imaging~     methods such as X-rays are not sensitive enough for detection.~   "
111950|NCT01590953|"~     Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled~     in a fitness program consisting 90 days of a structured exercise program and dietary~     counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and~     absenteeism rates will be measured at 0, 90 days, in one year.~   "
111970|NCT01590693|"~     The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable~     effect to treatment of idiopathic toe-walking with below knee walking casts. The specific~     hypothesis to be tested is that a combination of BTX and casting is more effective than~     casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation~     methods include 3-D gait analysis, parents' perception of toe-walking frequency, passive~     joint range of motion measurements, and strength of ankle dorsal extension.~   "
111951|NCT01590940|"~     The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic~     variability in the number and composition of meshes currently on the world market. The use~     of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These~     selected polymers have the ability to degrade while implanted, allowing for sufficient~     natural tissue healing and scarring. This usage presumably favors a decrease in foreignness,~     inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with~     similar plug meshes in the same indication have yielded favorable results which require this~     mesh to be investigated in its specific application.~      Primary Objective~      Evaluate the incidence of peri-operative and post-operative complications after the~     application of the Parietex plug and patch hernia system in open inguinal hernia repair. We~     will assess the efficacy of this mesh by examination and the application of a pain scale at~     the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended~     to evaluate:~        -  Patient report of pain via their Pain score~        -  Wound complication~        -  Incidence of chronic groin pain~        -  Recurrence rate~        -  Other complications Secondary Objectives~      Record the description and assessment of the Parietex plug and patch hernia system:~        -  surgical technique~        -  description of dissection and mesh placement~        -  method of fixation~        -  operative times, anesthesia choice~        -  length of hospital stay~        -  mesh handling characteristics~        -  return to daily activities~        -  overall patient satisfaction~   "
111952|NCT01590927|"~     Now a days the ultrasound is seen as a valid and reliable measurement tool to test the~     Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, & Galea, 2005). The~     hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM~     movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be~     used in measuring functional movements. In this Master thesis the hypothesis is to show a~     good reliability by trampoline jumping (physical activity).~   "
111953|NCT01590914|"~     Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain~     activation in response to highly palatable (high energy density [kcal/g]), less palatable~     and non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing~     bariatric surgery (in surgery patients) and at equivalent times for control groups in fed~     and fasted conditions at each time point.~      Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric~     banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month~     formula weight loss program or (ii) those who qualify, but do not undergo bariatric surgery,~     and receive no weight loss treatment.~   "
111954|NCT01590901|"~     The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral~     doses of probucol in healthy male subjects.~   "
111955|NCT01590888|"~     Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000~     people in both the United States and Australia. HD is characterized by brain cell death that~     usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral~     signs and symptoms. While there are medications to help relieve some of the disease~     symptoms, there is no known treatment to address the cognitive impairment associated with~     HD.~      Normally occurring metals in the brain play a significant role in diseases such as Alzheimer~     disease and HD. PBT2 is a drug designed to interrupt interactions between these biological~     metals and target proteins in the brain, to prevent deterioration of brain cells. PBT2, has~     shown in animal models, and as well as in a small group of patients with Alzheimer's~     disease, it may improve cognition. There is some indication in animal models of HD, that the~     drug may improve motor function and control and reduce the amount of brain cell~     degeneration.~      PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a~     day administered as oral daily capsules compared to a placebo over a six month treatment~     period. The trial will also measure whether there is an effect on cognitive abilities as~     well as other HD symptoms including motor and overall functioning of individuals with HD.~   "
111956|NCT01590875|"~     Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins~     during atrial fibrillation ablation, however, the methodology has not been validated either~     in terms of the reproducibility of the adenosine response or the effect on clinical~     outcomes, namely whether using pulmonary vein reconnection to guide additional ablation~     lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that~     the response to adenosine used in this manner is reproducible over time.~   "
111957|NCT01590862|"~     The primary aim of this study is to test the effects of excitation of ventral striatal~     circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators~     predict that stimulation will increase subject willingness to expend effort for rewards and~     facilitate motivation for reward learning. The investigators further predict that individual~     differences in the effects of DBS on reward motivation as will be associated with effects of~     DBS treatment on anhedonic symptoms.~   "
111958|NCT01590849|"~     The use of combined oral contraceptives has been associated with increased risk of adverse~     cardiovascular events. The exact mechanism by which these drugs exert this influence is~     uncertain. It is possible that changes in autonomic nervous system are involved. The~     objective of these study was to evaluate the effect of the use of a contraceptive containing~     20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in~     healthy women. Few studies have been conducted in the field of hormonal contraception and~     evaluation of the autonomic nervous system work and no prospective, controlled study was~     published so far. These study will be the first.~   "
111959|NCT01590836|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic response (the effect of the investigated drug on the body) of insulin~     degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.~   "
111971|NCT01590680|"~     Primary Objectives:~        -  Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma,~          pheochromocytoma, or paraganglioma.~        -  Gain more information about acute and late toxicity of 131I-MIBG therapy for patients~          with refractory neuroblastoma, pheochromocytoma, or paraganglioma.~   "
111972|NCT01590667|"~     The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy~     subjects, to provide more comprehensive and robust clinical evidence in its mode of action~     for the treatment of obesity and weight management through dietary fat binding.~   "
111960|NCT01590823|"~     Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and~     require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant,~     warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will~     difficulties given the multitude of drug and food interactions, need for frequent~     coagulation monitoring and dosage adjustment, and concern that warfarin enhances vascular~     calcification in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin~     inhibitor, has been approved for use in AF patients with normal renal function. Since many~     drugs are eliminated by the kidneys and removed from the plasma during dialysis, it is~     important to determine proper drug dosing in hemodialysis patients through evaluating~     pharmacokinetics.~   "
111961|NCT01590810|"~     This study will evaluate the safety and tolerability of MK-8150 and its effect on central~     systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given~     as single oral doses in healthy males and in males with mild-to-moderate hypertension. A~     primary study hypothesis is that post dose mean change from baseline of time-weighted~     average across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered~     MK-8150 compared to placebo in males with mild to moderate hypertension. A mean decrease~     from baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points~     in TWA0-24hrs AIx is considered clinically meaningful.~   "
111962|NCT01590797|"~     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to~     stable insulin alone or in combination with metformin in participants with type 2 diabetes~     mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition~     of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in~     T2DM participants on insulin alone or in combination with metformin.~   "
111963|NCT01590784|"~     Depression in patients with schizophrenia is common. Several factors was found to be~     associated with depression including medical illness, quality of life, positive symptoms,~     and typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly~     used for screening depression in schizophrenia,however; the Thai version of CDSS has not~     been validated.~      This study aims to a.) test the reliability and validity of the Thai version of Calgary~     depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors~     associated with depression in patients with schizophrenia including quality of life, type of~     antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the~     Faculty of Medicine, Chiang Mai University, Thailand.~   "
111964|NCT01590771|"~     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to~     stable sulfonylurea alone or in combination with metformin in participants with type 2~     diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the~     addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C~     (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.~   "
111965|NCT01590758|"~     The purpose of this study is to establish the clinical superiority and the safety of topical~     pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus~     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.~   "
111966|NCT01590745|"~     Carpal Tunnel Syndrome (CTS) is a recognisable pattern of symptoms and signs, which are~     caused by compression of the median (middle) nerve as it passes through the carpal tunnel at~     the wrist.~      This condition affects individuals by causing pain, numbness, tingling sensations and~     sometimes weakness in the fingers and may extend to shoulder and neck areas. The cause for~     most cases is unknown (idiopathic) though some common conditions are associated with an~     increased incidence, including obesity, pregnancy, hypothyroidism, arthritis, diabetes, and~     trauma.~      Diagnosis is primarily clinical and the condition is easily recognised from the~     characteristic symptoms in straightforward cases but diagnostic support is provided by~     investigations such as nerve conduction studies and ultrasound imaging.~      Treatment may include splinting, local steroid injection at wrist, activity~     modification,physical or occupational therapy (controversial), medications, and surgery.~     Treatment with local therapeutic ultrasound has been suggested to be effective but existing~     trials are inconclusive.~      Wrist splinting is only partially effective with a success rate of 34%, Steroid injection is~     followed by frequent relapses and there remains uncertainty about the safety of serial~     injections. Surgery is effective but has a small but significant incidence of permanent~     complications. Any demonstrably effective and safe addition to the therapeutic options would~     be a significant advance in treatment. Therapeutic ultrasound at present appears a promising~     option, having a very good safety record but so far uncertain evidence of efficacy.~      In our trial patients, with mild carpal tunnel syndrome, confirmed by nerve conduction~     studies, will all be given wrist splints so that no patients will be left untreated. They~     will be randomly allocated to either therapeutic or sham ultrasound therapy (20 sessions~     over 7 weeks) and followed up for 1year. The patients, operators of the ultrasound equipment~     and assessors will all be blind to treatment allocation.~      The effect of treatment on symptoms will be assessed using a validated questionnaire and~     nerve conduction studies will be repeated at completion of the ultrasound treatment, 6 and~     12 months.~      This study is designed to find out to whether therapeutic ultrasound is an effective~     treatment for carpal tunnel syndrome (CTS).~   "
111967|NCT01590732|"~     The goal of this clinical research study is find the highest tolerable dose of romidepsin~     that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients~     with PTCL. The safety of this drug combination will also be studied.~      Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from~     forming around the cancer cells. This may cause the cancer cells to die.~      Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.~      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell~     division, which may cause the cells to die.~   "
111968|NCT01590719|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with~     metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction.~     Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo~     in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or~     placebo until disease progression, unacceptable toxicity, patient or physician decision to~     discontinue treatment.~   "
111969|NCT01590706|"~     -  Although aging process appears to be generally characterized, investigators have been~          paid much attention to the specific target molecules, which leads to discover the~          clinical markers of the senescence. The present study is to investigate the clinical~          and biological profile of cognitive decline and functional cardiac senescence in~          healthy middle aged and elderly Korean volunteers.~        -  This study was conducted as a cross-sectional, single-center, comparative clinical~          study.~        -  Each volunteer was given informed consent for checking cognition and cardiac function.~          Blood and urine samples were collected to analyze genome, proteome, and metabolome to~          assess cognition and cardiac function of its muscle enzymes.~   "
111973|NCT01590654|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are~     required periodically through day 43. Subjects with sustained reductions in HbsAg will be~     requested to return for additional follow-up follow-up visits at 3 and 6 months post last~     dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic,~     and safety assessments~   "
111974|NCT01590641|"~     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2~     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and~     activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up~     visits are also required periodically through day 43, and potential viral load follow-up~     visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for~     pharmacokinetic, pharmacodynamic, virologic, and safety assessments~   "
111975|NCT01590628|"~     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a~     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells and a Second,~     Unmanipulated CBU in Patients with Hemoglobinopathies.~   "
111976|NCT01590615|"~     This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of~     follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of~     liver decompensation, death, or conclusion of the registry.~   "
111977|NCT01590602|"~     The study aims to monitor the progression of symptoms and signs of those affected by JHD~     using modified UHDRS scales of motor and function (functional assessment, TFC). This will~     provide some basic data to analyse the usefulness of the proposed rating scales.~     Specifically, the initial aim is to assess these rating scales using an iterative process.~      There may be significant delays in diagnosis of JHD especially if the young person presents~     with behavioural problems. Caregivers will be asked questions to capture the number of~     contacts with professionals in the time between onset of concerns about the young person and~     the confirmation of diagnosis.~      Aim is to monitor the progression of symptoms and signs of those affected by JHD using~     modified UHDRS scales of motor and function (functional assessment, TFC). This will provide~     some basic data to analyse the usefulness of the proposed rating scales.~   "
111978|NCT01590589|"~     This is a multi-centre, multi-national, prospective, observational study of Huntington's~     disease (HD) with a control group of volunteers to:~        -  obtain natural history data on many HD mutation carriers and individuals who are part~          of an HD family~        -  relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of premanifest and manifest HD which may also be~          potential outcome measures for use in future clinical trials and clinical care~        -  plan for future research studies~   "
111979|NCT01590576|"~     The purpose of this study is to investigate the comorbidities of lower urinary tract~     symptoms or pelvic organ prolapse in a nationwide population-based data in Taiwan during the~     study period of 2001-2010, a total of 10 years.~   "
111980|NCT01590563|"~     Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion,~     malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is~     inserted in a similar fashion into the uterus and takes a three dimensional spherical shape~     while curving away from the fundus. Apart for an anticipated reduction in the rate of stated~     complications, its smaller size and mallable characteristics are also expected to improve~     user experience. The clinical trial is intended to evaluate the safety and initial efficacy~     of this novel device.~   "
111981|NCT01590550|"~     Providing hemodialysis requires the use of an extracorporeal circuit which must be~     anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with~     decreased circuit blood flows, inefficient dialysis and even significant blood loss~     secondary to circuit clotting.Heparin has been traditional agent used to provide~     anticoagulation. Heparin has multiple adverse side effects that would be best avoided in~     acutely ill patients who are at risk for bleeding. Alternative means of providing~     anticoagulation include citrate based anticoagulation. Citrasate® is a heparin free~     anticoagulant alternative that has been FDA approved since 1999 and readily available for~     commercial use since 2001. Citrasate® utilizes citric acid instead of acetic acid for~     acidification; the presence of small amounts of citrate in the dialysate also provides the~     means for anticoagulation. The concentration of citrate is low (2.4meq/L) and thus has a~     minimal effect on serum calcium values. No calcium monitoring or infusion is indicated.~      The purpose of this study is to obtain further data on the use of Citrasate® in admitted~     pediatric patients who receive hemodialysis as part of their therapy for acute kidney~     injury.~   "
111982|NCT01590537|"~     This is local prospective, non-interventional multi-center comparative study. Primary study~     objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year~     after insertion ( patient assessment questionnaire) in daily practice. For each patient, the~     treating gynecologist documents demographics, medical data, safety parameters and treatment~     signs and symptoms at an initial visit and one or two follow-up visit(s).~   "
111983|NCT01590524|"~     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle~     relaxation are effective as stress reducing techniques in parents of hospitalized children~     with cancer.~   "
111984|NCT01590511|"~     The main objective of this study is to show that the variation of the subaortic velocity~     time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100)~     is predictive of response to filling (defined as an increase in aortic velocity time~     integral measured by transthoracic ultrasound over 15% after administration of 500 cc of~     normal saline over 15 minutes) in non-ventilated shock patients.~   "
111985|NCT01590498|"~     The purpose of the study is to determine whether radiotherapy improves cancer control and~     overall survival among patients with Castration resistant prostate cancer.~   "
111986|NCT01590485|"~     The purpose of this study is to determine whether saffron is effective in the pain control~     after root canal therapy in vital teeth.~   "
112051|NCT01589627|"~     The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for~     wrist extension contracture following a distal radius fracture.~   "
111987|NCT01590472|"~     The purpose of this research study is to investigate the possibility that a person's genes~     put a person at a higher risk of developing mesothelioma. The investigators will examine~     genes from DNA (genetic material) isolated from blood. This study will also examine the~     impact of environmental and work exposures and family history of common cancers on the~     development of mesothelioma. The genetic markers in this study will basically identify how a~     person's body processes frequently encountered environmental pollutants and will not tell~     about chromosomes, specific diseases, or other potential health problems.~   "
111988|NCT01590459|"~     This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3~     inhibitor, for treatment of subjects with active RA who have had an inadequate response to~     Methotrexate.~   "
111989|NCT01590446|"~     The purpose of this study is to measure how much of the study drug gets into the blood-~     stream and how long it takes the body to get rid of it when given as a single dose.~     Information about any side effects that may occur will also be collected.~   "
111990|NCT01590433|"~     The investigators are conducting a study that will investigate the possible mechanisms of~     weight loss associated with exenatide treatment and the metabolic characteristics of high~     responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment.~     The investigators will also examine the magnitude and duration of weight loss among a cohort~     of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.~      Hypothesis:~      The mechanisms of weight loss with exenatide are not fully understood, and weight loss~     responses to exenatide are highly variable, possibly reflecting distinct metabolic~     parameters. By identifying and following a group of obese women who lose greater than 5%~     body weight after short-term exenatide treatment, the investigators can gain insights into~     the possible mechanisms of weight loss and assess long-term weight loss with this~     pharmacotherapeutic intervention.~   "
111991|NCT01590420|"~     The purpose of this study is to estimate the cost-utility of continuous positive airway~     pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil,~     after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of~     medical visits, hospitalizations, medical examinations, used medications, new case incidence~     and cost of traffic accidents and absence from work. It is also designed to estimate~     quality-adjusted extended years of life, and to assess cost-effects of the therapy (device,~     masks, supplies, maintenance/year for membership of professional consulting, electric power)~     on the cost-effectiveness~   "
111992|NCT01590407|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers~     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.~      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will~     assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing~     pharmacokinetics and safety in subjects with CHC genotype 1 infection.~   "
111993|NCT01590394|"~     Plastic biliary stents which are a new larger size will remain free of obstructions for a~     longer period of time than currently used 10 French stents in cancer in the common bile~     duct.~   "
111994|NCT01590381|"~     The purpose of this study is to assess HBV immunity and institute policy regarding the~     Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during~     infancy.~   "
111995|NCT01590368|"~     It is hypothesised that the adhesion of electrodes and acceptability of the~     Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test~     products) after 30 minutes (the intended period of use) of the electrodes.~   "
111996|NCT01590355|"~     The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx~     is radiation therapy. Some patients require chemotherapy with the radiation, and some~     patients require surgery if the tumour or lymph nodes have not responded after radiation.~      This study will compare radiation therapy with a new surgical treatment called transoral~     robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon~     in removing the tumour, potentially with fewer side effects than older surgical techniques.~   "
111997|NCT01590342|"~     The primary objective is to demonstrate the clinical benefits of diclofenac (added to~     standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic~     pulmonary embolism and right ventricular dysfunction.~      The secondary objective is to assess the safety after administration of diclofenac in~     normotensive patients with acute symptomatic pulmonary embolism and right ventricular~     dysfunction.~   "
111998|NCT01590329|"~     This case series will assess the use of suction blister epidermal grafts harvested by a~     novel device on select patients with hypo pigmented skin or surgical skin wounds.~   "
111999|NCT01590316|"~     Background 25,000 infants are born extremely preterm every year in Europe. This group of~     infants carries a high risk of death and subsequent cerebral impairment for the infant,~     especially in the first 72 hours of life. Mortality is about 20%, and about 25% of survivors~     live with either cerebral palsy or low intelligence quotient. Preventative measures are keys~     to reducing mortality and morbidity in this population. There is evidence that the cerebral~     oxygenation time spent out of range (time with hypoxia or hyperoxia) is associated with poor~     outcome in infants. Near-infrared spectroscopy (NIRS) has been used to monitor tissue~     oxygenation since the mid-1980s, and quantification of oxygenation (rStO2) in a percentage~     from 0 to 100% has been possible for 10 years. From almost 400 preterm infants normal ranges~     of rStO2 has been determined to be from 55% to 85%. Still, there are no clinical trials and~     thus no solid evidence of the clinical utility of NIRS in preterm infants. Thus, research on~     the benefits and harms of cerebral monitoring using NIRS as a part of clinical management of~     premature infants is much needed.~      Objectives The primary objective of the SafeBoosC trial is to examine if it is possible to~     stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of~     life through the application of cerebral NIRS oximetry and implementation of an~     rStO2-specific clinical treatment guideline. We hypothesise that by using the specified~     treatment guideline to respond to cerebral monitoring readings outside the target range, we~     would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury.~      Trial design This is an investigator-initiated randomised, blinded, multinational, phase II~     feasibility clinical trial involving preterm infants from 12 European countries.~      Inclusion criteria The inclusion criteria are: neonates born more than 12 weeks preterm~     (gestational age up to 27 weeks and 6 days); decision to conduct full life support; parental~     informed consent; and cerebral NIRS oximeter placed within 3 hours after birth.~      Sample size With a 50% reduction of the area outside the normal range of oxygenation in~     %hours in the experimental group compared to the control group as the minimal clinically~     significant difference, a standard deviation of the area outside the normal range of 83.2~     %hours, a type I error (alpha) of 5%, and a type II error of 0.05 (power of 95%) inclusion~     of 75 preterm infants in the experimental group and 75 preterm infants in the control group~     is required. The inclusion of twins are likely to decrease power, so it has been decided to~     increase sample size to 165 on a pragmatic basis of estimating intracluster correlation,~     control event rate, and incidence of twin births.~      Intervention The premature infants will be randomised into one of two groups (experimental~     or control). Common is that both groups will have a cerebral oximeter monitoring device~     placed within three hours after birth. In the experimental group, the cerebral oxygenation~     reading is visible, and the infant will be treated accordingly using a defined treatment~     guideline. In the control group, the cerebral oxygenation reading is NOT visible, and the~     infant will be treated as usual.~      Trial duration Monitoring by cerebral oximeter will be started as soon as possible and~     within 3 hours after birth and the intervention will last for 72 hours. Thereafter, each~     neonate will be followed up at term date (approximately three months after birth) and at 24~     months after term date.~      Outcome measures The primary outcome is the burden of hypo- and hyperoxia in %hours during~     the first 72 hours after birth. The secondary outcomes are brain activity on an~     amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding~     protein (BFABP), neuroketal, and S100β), serious adverse reactions (SARs), severe brain~     injury, and all cause mortality at term date (approximately three months after birth). The~     exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain~     injury score on magnetic resonance imaging (MRI), number of therapies implemented during the~     intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen~     saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor~     impairment according to neurodevelopmental scales at 24 months after term date.~   "
112000|NCT01590303|"~     This study is designed to determine if Vitamin C administration to septic patients will~     result in an improvement in organ dysfunction which occurs during a septic illness.~      Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce~     the length of time on a ventilator, length of stay in the intensive care unit and in~     hospital.~   "
112001|NCT01590290|"~     The purpose of this study is to determine if a pay for performance model in contrast to the~     traditional fee for service model may improve the number of patients discharged being~     treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit~     organization that accredits health care organizations) standards and standard of care for~     management of hyperlipidemia~      In this study the investigators will evaluate these two models by training resident~     physicians (doctors in training) on JCAHO core measures and specific criteria related to~     accepted standard of care for acute myocardial infarction and heart failure. The physicians~     will be randomized to a pay for performance or a fee for service model. Then a medical~     record review will be performed on patient records that received a discharge diagnosis of~     myocardial infarction or heart failure and were cared for by the physician subjects~   "
112002|NCT01590277|"~     Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is~     looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's~     effects on driving an automobile.~   "
112052|NCT01589614|"~     The purpose of this study is to investigate the effect of co-administration with~     erythromycin on the time course of PH-797804 concentration in the blood following dosing by~     oral immediate release tablet formulation.~   "
112003|NCT01590264|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique~     that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex.~     The investigators propose an open-label pilot study investigating the effectiveness of rTMS~     in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC),~     an area known to be important for mood and attention, along with stimulation of the left~     temporoparietal cortex (TPC). This is a feasibility pilot study.~   "
112004|NCT01590251|"~     This study is designed to develop an effective adjunctive treatment using yoga for chronic~     pain and opioid dependence.~   "
112005|NCT01590238|"~     Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active~     production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal~     findings of improvement of hair appearance after PRFM injection in the scalp suggest that~     PRFM may play a role in the treatment of thinning hair. Patients will be treated on a~     monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair~     density will be assessed by comparing pre- and post-treatment photographs and non-invasive~     measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.~   "
112006|NCT01590225|"~     This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of~     boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In~     Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who~     are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to~     (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment~     failure) (Part B). Part C is long-term follow up and no study treatment will be administered~     during this period, but participants who do not achieve viral clearance will be allowed to~     receive other treatments for CHC.~   "
112007|NCT01590212|"~     The purpose of this study is to compare the effectiveness of a relationships based antenatal~     intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and~     also against the normal antenatal care which is received during pregnancy (Care As Usual).~     The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity~     whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety.~     This will allow the researchers to determine what type of intervention, if any, is most~     successful at improving the outcomes of the mother and child. This will be measured by~     looking at the mother's stress response, anxiety, depression and irritability, the baby's~     stress response and the interactions between the mother and the baby. Participants in the~     study will be pregnant women who would be between 20 and 30 weeks pregnant at the start of~     the antenatal intervention. Participants will be chosen to take part in one of the three~     conditions (Mellow Bumps, Chillout In Pregnancy or Care As Usual) at random. All~     participants will be asked to complete questionnaires and give saliva samples prior to the~     intervention. The questionnaires will also be repeated at the end of the intervention and at~     a follow up occurring eight to twelve weeks after birth. Consent will also be sought to take~     saliva samples from the baby before and after a routine blood test when the baby is five~     days old. This information will then be evaluated to establish the effectiveness of the~     proposed interventions.~   "
112008|NCT01590199|"~     This study will evaluate long-term safety and tolerability of pasireotide LAR in combination~     with everolimus in advanced metastatic NET patients, who who have not progressed during 12~     months of combination therapy with pasireotide LAR and everolimus.~   "
112009|NCT01590186|"~     Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity~     is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore,~     metatarsalgia can be a sign of excessive load caused by sport activities or at work. The~     condition is very common at diabetics and patients with rheumatism.~      The purpose of the study is to examine the load under the front foot at health people and~     patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the~     best treatment of the flat foot deformity at each patient.~   "
112010|NCT01590173|"~     The addition of heparin and prednisolone increases pregnancy outcome parameters in women~     undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.~   "
112011|NCT01590160|"~     Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal~     pleural mesothelium, and is associated with exposure to asbestos.~      Once a rare disease, it is increasing in incidence in the UK and is presently more common~     than cervical cancer. MPM is characterized by local invasion of adjacent structures~     including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive~     shortness of breath.~      Median survival with best supportive care alone is approximately 6-9 months and most cases~     of mesothelioma present in the advanced setting. Therefore this trial will be looking at~     whether a new drug, Ganetespib has any improvement on survival for these types of patients.~   "
112012|NCT01590147|"~     This randomized clinical trial studies the preliminary efficacy of a yoga skills training~     (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in~     patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue,~     other treatment-related symptoms, and improve the quality of life (QOL) of patients with~     colorectal cancer. It is not yet known whether YST is more effective then CE in reducing~     these outcomes.~   "
112013|NCT01590134|"~     Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat~     anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators~     think that there could be ways to reduce the number of iron tablets needed, by increasing~     the dietary intake of iron. In this study the investigators will assess the efficacy and~     safety of a dietary iron supplement compared to iron tablets using controls and new~     biomarkers.~   "
112014|NCT01590121|"~     Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal~     blood vessels which makes them more likely to bleed than other people, particularly in the~     lungs, which results in low blood oxygen levels. Flying may make this worse and cause~     problems. The investigators want to know if there are an increased number of problems on~     flights compared to on land.~      The investigators currently do not have any evidence based guidelines on air travel to best~     advice people who suffer with HHT. The investigators would therefore like to ask individuals~     who have HHT about their experience on a flight, using a postal questionnaire.~   "
112015|NCT01590108|"~     The purpose of this study is to~        -  Determine blood peptide levels and investigate any tissue gradients of apelin in~          patients with idiopathic pulmonary arterial hypertension and healthy volunteers.~        -  Evaluate the effect of exogenous apelin infusion on exercise performance in healthy~          volunteers and patients with idiopathic pulmonary arterial hypertension.~   "
112016|NCT01590095|"~     Brief Summary:~      The purpose of this study is to measure the independent and combined effects of~     interventions that improve water quality, sanitation, hand washing, and nutrition on child~     growth and development in the first years of life.~   "
112017|NCT01590082|"~     The goal of this clinical research study is to find the highest tolerable dose of~     doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced~     melanoma. The safety and level of effectiveness of the study drug combination will also be~     studied.~      Doxycycline is designed to treat bacterial infection. It also blocks a protein called iNOS~     that is important in tumor cell growth, which may slow the growth of or kill cancer cells.~      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~      Ipilimumab is designed to block the activity of cells that decrease the immune system's~     ability to fight cancer.~   "
112018|NCT01590069|"~     The goal of this clinical research study is find the highest tolerable dose of interleukin-2~     (IL-2) that can be given as an inhaled mist to patients with lung metastases. The safety of~     this drug using this administration will also be studied.~      IL-2 is a protein that triggers white blood cells, called natural killer cells or T-cells,~     to kill cancer cells. When given as a shot or by vein, IL-2 has been known to cause fevers~     and flu-like side effects, including rashes, fatigue, and extra fluid in the skin or lungs.~     These symptoms are less when IL-2 is inhaled as a mist into your body.~   "
112019|NCT01590056|"~     About 300 patients with Parkinson's disease (PD) have been successfully treated by deep~     brain stimulation (DBS) during the last 10 years in Hadassah. In most of the patients the~     site of stimulation is the subthalamic nucleus (STN). Recent studies by our group and others~     have demonstrated that the STN is divided into motor and non-motor areas. The investigators~     have recently shown that electrophysiological mapping of the STN during the surgery can~     differentiate motor and non-motor areas of the STN. Existing methods of adjustment of DBS~     parameters aim at amelioration of the motor signs and therefore with inactivation of the STN~     motor territory only. Although the DBS parameter setting is believed to influence the mental~     and cognitive states, there is no data that correlates stimulation parameters with mental~     and cognitive state. In addition, DBS parameter setting is also believed to influence~     important verbal functions which are partially related to motor, mental and cognitive~     states, but no data correlates the verbal function with the DBS stimulation parameters.~      The investigators hypothesize that the cognitive areas of the STN have distinct~     electrophysiological properties similar to our findings with the limbic / mental areas of~     the STN. The investigators further hypothesize that specific stimulation of these cognitive~     areas can influence the cognitive state and thus treatment with cognitive-adjusted DBS can~     improve the cognitive symptoms of PD.~      In this project, the investigators intend to map the motor, emotional and cognitive areas of~     the STN using neuronal (single units) responses to emotional voices and cognitive tasks and~     to identify the emotional and cognitive spectral signature of the STN single unit activity~     using spectral analysis and neuronal responses to emotional voices and cognitive tasks. In~     addition the investigators intend to find the neuronal signature of speech and to find the~     correlation between motor, mental and limbic electrophysiology to speech. The investigators~     also intend to investigate the motor, emotional and cognitive processing of PD patients by~     manipulating the stimulation of the STN. The proposed study will combine neural recording,~     stimulation and psychological and cognitive tests to shed new light on processing in the~     basal ganglia, as well as to provide better treatment for PD patients.~   "
112020|NCT01590043|"~     Under normal conditions intestinal mucosa presents a baseline physiological inflammation~     caused by a controlled immune response that eliminates offending dietary and microbial~     antigens. This inflammation disappears once the cause is eradicated. In case of~     inappropriate immunological response, the inflammation becomes chronic and harmful,~     resulting in anatomical and functional abnormalities, namely inflammatory bowel disease~     (IBD).~      Although it is critical for the IBD patients to undergo early diagnosis and management~     before the development of severe complications, but as IBD has vague and non-pathognomonic~     clinical features, the clinician is usually mislead into late suspicion and detection of~     IBD.~      Diagnosis traditionally depended on a combination of pathologic evaluation together with the~     histological, clinical, radiological, endoscopic, surgical, laboratory (serological)~     features. Recently, serological markers were identified and became of special interest as~     they do not only detect the occurrence of IBD but also the potential of its development and~     may be used as prognostic tools. More recently, stool markers were detected and used for~     diagnosis.~      Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic~     tool. Saliva can present an alternative form of body fluids that simplify diagnostic~     procedures.~      Our hypothesis is that IBD patients have special salivary biomarkers that may be identified~     through salivary analysis, where later on a simple non-invasive test can be applied in the~     form of an easy-to-use kit, being available at the clinician's clinic for the establishment~     of an immediate and early diagnosis of the destructive inflammatory bowel disease.~   "
112021|NCT01590030|"~     The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and~     fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.~   "
112022|NCT01590017|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together~     with radiation therapy may be an effective treatment for cervical cancer.~      PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating~     participants with HIV-associated locally advanced cervical cancer.~   "
112023|NCT01590004|"~     This study aims to develop a technical description of lumbar medial branch ablation using~     the LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in~     treating patients with diagnosed lumbar facet joint pain.~   "
112024|NCT01589991|"~     Fluoride toothpaste has been associated not only with declining dental caries prevalence but~     also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride~     toothpaste use, the purpose of this study is to evaluate the availability of fluoride~     concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries~     effect), and the fluoride concentration in urine, as an indicator of fluoride absorption~     from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young~     Brazilian children using toothpaste formulations representative of those available and most~     used by this age-group.~   "
112025|NCT01589978|"~     This study is designed to observe clinical outcomes in patients receiving the PROMUS Element~     Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical~     practice. Patients will have symptomatic heart disease or documented silent ischemia. This~     is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5~     years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United~     States.~   "
112026|NCT01589965|"~     The HIV/AIDS epidemic is a major concern in many countries. The epidemic is especially acute~     in Lesotho where roughly one quarter of the population is infected by HIV/AIDS. In Lesotho,~     and elsewhere, new innovative approaches to induce safer sexual behavior have been~     desperately called for, particularly in view of the limited impact that existing prevention~     schemes have had on the trajectory of the HIV/AIDS epidemic.~      One of the key questions is to understand why individuals get involved in short-term risky~     sexual behavior when the potential long-term cost of becoming HIV infected is so high? A~     follow-up question is what replicable and feasible interventions can affect this trade-off~     between short and long run returns? The primary aim of this study is to evaluate whether the~     use of short-term financial incentives can affect this trade-off, thereby influencing young~     individuals' decisions with respect to sexual and reproductive health behavior, and thus in~     the end reduce HIV incidence rates. The investigators will study this question using a~     sample of population attending served by New Start Voluntary Counseling and Testing (VCT)~     sites that a local NGO, Population Service International (PSI), has already implemented in~     Lesotho.~      The investigators propose to conduct a randomized controlled trial to test whether adding a~     financial incentive to remain STI-negative in the form of a lottery can promote safer sexual~     activity. The lotteries will work as follows: if the individual is tested negative on a set~     of curable STIs, she will get a lottery ticket with the chance to win a big prize. If she~     is tested positive, she will receive free treatment, but no lottery ticket. If an individual~     who tested positive is cured, she can come back in the lottery system and get a later chance~     to win the lottery ticket if she remains STI-negative. The outcome will be to measure the~     impact of financial incentives on HIV incidence after two years.~      The results of this research project will be disseminated through academic and non-academic~     conferences, workshops, publications in academic journals, and also in policy journals with~     the aim to reach out to policy makers outside the research community.~   "
112027|NCT01589952|"~     According to published literature, treatment with pegylated interferon (Peg-IFN) is~     associated with end of treatment response in treatment naive patients with chronic hepatitis~     B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN~     results in improvement of liver histology and down regulation of progression to cirrhosis of~     liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is~     that only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral~     drug, entecavir (ETV), on the other hand, reduces HBV replication in most patients, but~     causes improvement of liver histology in only 30%, possibly because of its lack of immune~     modulatory ability like Peg-IFN. Also, ETV treatment is associated with several~     complications like emergence of HBV mutant. The aim of this study is to assess whether the~     combination of these two 'unique' anti-viral drugs offer the best possible outcome to~     treatment-naïve CHB patients, in terms of treatment response (virological and biochemical),~     treatment cost and duration and adverse events.~   "
112028|NCT01589939|"~     This prospective study evaluates the clinical utility of a novel real-time localization~     system allowing for smaller volumes of normal tissue to be included in radiation field and~     determines dosimetric parameters and adverse effect profiles of radiation therapy using this~     technology. Subjects will have beacon transponders implanted into the prostate to more~     precisely localize the position of the organ during radiation therapy. Hypothesis: 1.~     Treatment with highly targeted radiation therapy can be delivered in a daily treatment time~     consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced~     PTV margin will result in a significant decrease in rectal and bladder volume treated.~   "
112029|NCT01589926|"~     Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is~     diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever,~     or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an~     exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level~     Positive Airway Pressure (BLPAP) is a device that blows air into a patients lungs via a mask~     that covers the nose. Our goal is to determine whether giving children BLPAP when they have~     ACS, in addition to providing standard clinical care for ACS alters the clinical course of~     these patients. The investigators hypothesize that patients receiving effective BLPAP will~     have milder clinical courses resulting in shorter hospital stays and fewer transfers to the~     intensive care unit and exchange transfusions.~   "
112030|NCT01589913|"~     Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many~     ICD-patients experience psychosocial complications such as anxiety disorders, depression and~     reduced quality of life after ICD-implantation. A recent review has indicated great~     potential for psychosocial interventions to reduce anxiety and to increase exercise capacity~     of ICD-patients. In a previous study, the investigators showed that mailed information about~     technical, medical and psychological effects of ICD plus phone counseling are effective~     interventions for reducing anxiety, psychological distress and increasing QoL in~     ICD-patients < 65 years. In a pilot study the investigators also documented promising~     effects of an internet based intervention with similar content.~      Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized,~     controlled clinical trial N = 200 patients with an ICD will either receive medical care as~     usual or additionally attend a psychosocial prevention program via remote care. Psychosocial~     support will be provided utilizing the advantages of the internet. Thus, patient-centered~     support will be offered independent from time and location.~      Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac~     functioning, and clinical status which will be assessed up to 1 week before ICD-implantation~     (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12~     months after T0 (T3). Furthermore, demographic data, personality characteristics,~     expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as~     mediating or moderating variables.~      Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads~     to increased QoL and reduced anxiety and depression. Secondary goals are the identification~     of psychosocial and medical predictors, mediators, and moderators of treatment efficacy.~     Moreover, differences between patients with ICDs implanted for primary vs. secondary~     prevention will be explored.~      Conclusion: This project will evaluate the feasibility and efficacy of an internet based~     intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors~     and mediators of treatment outcome. This will improve interdisciplinary care for~     ICD-patients; further applications for other cardiovascular disorders as well as preventive~     programs for heart failure seem possible.~   "
112031|NCT01589900|"~     Sox2 has been studied in several types of human solid tumors. The investigators found that~     Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal~     tissues. So the investigators assumed that whether Sox2 plays an important role in the~     progression and migration of colon cancer.~   "
112032|NCT01589874|"~     Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal~     iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC)~     survival is a very common problem in hospitalized patients for acute inflammatory diseases~     and develops within few days from the onset of illness. Deleterious effects of anemia~     include increased risk of cardiac related morbidity and mortality in critically ill and~     older patients.~      Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to~     iron trafficking.~      Several studies have been performed on pathophysiology of AI in patients affected by chronic~     diseases but few explore iron metabolism in humans with acute inflammation.~      The aim is to develop effective new strategies to detect and manage AI in the setting of~     acutely ill patients, based on the understanding of iron balance underlying this disorder.~   "
113838|NCT01566149|"~     The purpose of this study is to assess the safety, tolerability & effectiveness of 2~     strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the~     treatment of persistent asthma in adults & adolescents.~   "
112033|NCT01589861|"~     This study is based upon the following points:~        1. Resistance to trastuzumab, either primary or secondary, is a clinically relevant issue.~        2. PI3K/AKT activation, due to loss of expression/function of PTEN and/or activating~          mutations of PIK3CA, is a mechanism of resistance with clinical relevance in breast~          cancer. Such activation can be detected by:~             -  IHC evaluation of PTEN protein expression~             -  genotyping of PIK3CA exon 9 and 20~             -  IHC evaluation of phospho-AKT expression~        3. BKM120 is an effective PI3K inhibitor. BKM120 and anti-HER2 therapy may have a~          synergistic antitumor activity in preclinical model of HER2+ breast cancer.~        4. Lapatinib is an effective anti-HER2 therapy in trastuzumab-resistant disease.~        5. For the evaluation of novel targeted therapies, selecting a patient population enriched~          for activation of the target to be modulated should allow to maximize the differences~          in clinical outcome that are expected in the experimental arm, and thus to minimize the~          patient number to include.~        6. We propose to test in a phase I/II study the combination of lapatinib and BKM120 in~          trastuzumab-resistant HER2+ MBC patients, enriched for activation of PI3K/AKT as~          detected by loss of expression of PTEN (IHC), and/or mutation of PIK3CA and/or~          overexpression of phospho-AKT (IHC). Only for phase II patients, mutational status will~          be an inclusion criteria. For phase I patients molecular status will be a retrospective~          exploratory analysis.~   "
112034|NCT01589848|"~     1. Hypothesis~           a. There are patients with von Willebrand Disease in Cuenca.~        2. Primary question~           a. How many women referred with a history of bleeding may have von Willebrand disease?~        3. Secondary~             1. Associations between the bleeding score and initial laboratory studies~             2. What are the differences on subgroups of enrolled patients with the bleeding~               score?~        4. Ancillary~             1. What is the clinical and socio-economic status of women with von Willebrand~               Disease in Cuenca?~             2. What is the clinical and socio-economic status of patients with Hemophilia in~               Cuenca?~   "
112035|NCT01589835|"~     Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and~     approximately 50% of these will develop type 2 diabetes within five years. The investigators~     wish to help these people change their lifestyle, to prevent them from getting diabetes.~     Trials have shown that by supporting people with prediabetes to be more active and have~     healthier eating habits they can halve their risk. However, these interventions were very~     costly and not performed in Canada. With the help of local Family Physicians and other~     health professionals (e.g. physiotherapy, psychology, endocrinology, nursing) the~     investigators have created a less expensive intervention suitable for the Canadian~     population and health system. The investigators need to perform a study to see whether these~     modified approaches are practical for Canadians and likely to be effective. People at risk~     will be invited to participate from family practices that have helped us in the initial~     stages of this program. Family practices will be randomized to giving either the study~     intervention or continue with the physician's usual care. People receiving the intervention~     will have an appointment with their family doctor to discuss their exercise and eating~     habits and agree changes that are necessary. A prescription detailing these changes will be~     completed and signed by the family physician and participant. Participants will be given the~     name of a lifestyle change facilitator (LCF) who will receive a copy of the prescription and~     contact the participant to help them set achievable goals. The LCF will contact participants~     once a month for six months to help them achieve these goals. The investigators eventual aim~     is to test this intervention in a large-scale randomized control trial. To achieve this it~     is necessary to pilot all aspects of the trial. Information from the pilot study can then be~     used to design and perform a large-scale study effectively. The investigators hope that~     eventually the numbers of Canadians progressing to having diabetes will be reduced.~   "
112036|NCT01589822|"~     The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin~     Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.~   "
112037|NCT01589809|"~     The purpose of the interventional study is to determine whether Nicotinamide is effective at~     upregulating the Frataxin (FXN) gene in patients with Friedreich's ataxia (FRDA) where this~     gene is abnormally 'switched off'.~      The purpose of the non-interventional study is to investigate the use of novel,~     highly-sensitive technology to capture clinical deficit and measure subtle changes in the~     activities of daily living and to correlate functional changes to levels of expression of~     Frataxin protein and the epigenetic structure of the Frataxin gene over a 9-12 month period~     without nicotinamide. Healthy volunteers will be included as comparators in this part of the~     study.~   "
112038|NCT01589796|"~     Pain relief after open inguinal hernia repair could be improved by administration of TAP~     block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The~     investigators hypothesize that doing TAP block closer to the middle of the abdomen would~     result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric~     nerves.~   "
112039|NCT01589783|"~     Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of~     this vitamin for the proper development of the fetus, are a significant risk group. The~     purpose of this study is to examine which factors - education, knowledge from~     non-professional sources, recommendations from medical staff - influence the use of vitamin~     D among pregnant women in light of the lack of a clear health policy, and to help~     formulating guidelines for a new health policy with specific recommendations for vitamin D~     dosage in pregnancy.~   "
112040|NCT01589770|"~     Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart~     disease than people that do not have RA. we believe this is caused by the inflammation~     produced by RA.~   "
112053|NCT01589601|"~     The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary~     palliative care intervention combined with usual heart failure management on health-related~     quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the~     Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.~   "
112054|NCT01589588|"~     This study will investigate the possible difference in treatment effect between three~     different oxygen delivery systems in the acute treatment of cluster headaches.~   "
112055|NCT01589575|"~     The main objective of this study is to compare the rate of reported anxiety / depression~     (HADS >= 8) among spouses and other family members in ICU patients.~   "
112056|NCT01589562|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and~     Megace 800mg/20ml in healthy male volunteers under fed condition.~   "
112057|NCT01589549|"~     A randomised study of corticosteroid therapy with or without mesenchymal stromal cell~     therapy for newly diagnosed acute graft versus host disease after bone marrow~     transplantation or donor lymphocyte therapy.~      It is hypothesised that mesenchymal stromal cell therapy will be superior~   "
112058|NCT01589536|"~     The purpose of the study is to verfiy the hypothesis if a short intensive~     psychocardiological interval-intervention, combined with a structured follow up, decreases~     the rate of disability retirements caused by psychosocial co-morbidity of patients with~     coronary heart disease.~   "
112041|NCT01589757|"~     MAIN STUDY: Low glycaemic index (GI) diets are recommended by the Canadian Diabetes~     Association for treating type 1 and 2 diabetes mellitus (DM), but the role of GI in the~     management of gestational diabetes(GDM)is not yet clear. The main purpose of this study is~     to determine the effect of a low GI diet on blood sugar control in women with GDM. The~     effect of a low GI diet on maternal oxidative stress, pregnancy and delivery outcomes and~     markers of risk for diabetes after birth in both the mother and baby will also be assessed.~     SUB-STUDY: The main purpose of the sub-study is to determine if the breast milk (BM) of~     women with GDM consuming a low GI diet will have a higher antioxidant capacity than the BM~     of women receiving a medium-high GI diet (control/standard care). The effect of a low~     glycaemic index diet on maternal dietary intake of specific nutrient-antioxidants (i.e.~     vitamin C, E, and beta-carotene) (prenatal and postpartum) and concentration of vitamin C,~     E, and beta-carotene in participants' transitional and mature BM will also be assessed. The~     ORAC (Oxygen radical absorbance capacity) assay will be used to assess overall antioxidant~     capacity. The antioxidant capacity of BM in women with GDM will also be compared with that~     of women without GDM.~      Hypotheses:~      MAIN: The use of low-GI foods in the management of GDM reduces postprandial BG and oxidative~     stress; thereby reducing maternal and infant perinatal complications.~      SUB-STUDY: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM~     antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have~     lower antioxidant capacity than that of women without GDM.~   "
112042|NCT01589744|"~     The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical~     practice, if after giving birth, the placenta is not expelled naturally, an active~     management should be triggered. Escalating therapy after obstetric maneuvers (placenta,~     uterus, examination of the birth canal), begins with uterotonic treatments for invasive~     treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of~     these techniques and the desire to preserve fertility required to devise new therapeutic~     solutions, which have recently led to the development of an innovative medical device~     intrauterine hemostasis.~      The postpartum haemorrhage are mainly the result of weak and bleeding from the surface~     corresponds to the placental insertion, which is no longer localized. With the innovative~     medical device, our main hypothesis is that the uterine walls will append to the walls of~     the cup after depressurization of the latter. The actuation of the suction cup will lead to~     aspiration of all sides of the uterus (it is mostly the anterior and posterior that are~     important). The suction cup is flexible to adapt to the size of the uterus in order to be~     placed and removed easily from the uterine cavity.~   "
112043|NCT01589731|"~     Bovine β-lactoglobulin (Bos d 5) is an allergen from cow's milk with relevance to human~     health. We employed β-lactoglobulin polymerized using microbial transglutaminase as a model~     of study to identify whether protein polymerization could reduce in vivo allergenicity and~     maintain in vitro and ex vivo immunoreactivity for the purpose of producing a suitable~     molecule for use in tolerance-induction protocols. Based on previous protocols applied in~     mice and children, we performed in vivo challenges (using a skin prick test) with native and~     polymerized β-lactoglobulin in adult patients with an IgE-mediated allergy to Bos d 5. In~     vitro humoral immunoreactivity was analyzed using immunoblotting. Cell-mediated~     immunoreactivity was analyzed using ex vivo challenges with native and polymerized~     β-lactoglobulin monitored by leukocyte adherence inhibition tests. The study hypothesis is~     to identify a decrease on beta-lactoglobulin immunoreactivity after polymerization.~   "
112044|NCT01589718|"~     The purpose of this study is to assess whether preoperative pegaptanib sodium safely~     improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of~     pre-existing tractional retinal detachment.~   "
112045|NCT01589705|"~     There are substantial data demonstrating increased endothelial dysfunction, inflammation and~     oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the~     association between serum uric acid level and endothelial dysfunction has not been~     elucidated yet in these patients. Therefore, in this study, the investigators aimed to~     examine the relationship between the uric acid level and the ED in normotensive ADPKD~     patients with preserved renal function.~   "
112046|NCT01589692|"~     In the United States, over 300,000 individuals over age 65 suffer from distal radius~     fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of~     experience treating DRFs, management of elderly DRFs is still controversial. Close reduction~     and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures,~     common in the elderly, often collapse and displace. The three currently applied surgical~     techniques are close reduction and percutaneous pinning, external fixation with or without~     percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence~     indicates that locking plate fixation can permit elderly patients to move their hands and~     wrists much sooner in order to return to self-care activities more quickly. Although these~     outcomes are promising, there is no randomized controlled clinical trial to demonstrate that~     the more invasive, and perhaps more costly, plating technique is superior to the other~     simpler approaches.~      The specific aim of this 18-center randomized controlled trial is to compare outcomes of~     these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim~     is to follow a cohort of elderly patients who choose not to have surgery to evaluate~     outcomes following treatment by close reduction and casting alone. This clinical trial is~     the most ambitious study in hand surgery by assembling most of the leading centers in North~     America to collect evidence-based data to guide future treatment of this prevalent injury in~     the growing elderly population.~   "
112047|NCT01589679|"~     To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of~     hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.~   "
112048|NCT01589666|"~     This study is a Phase 1, single-center, open-label, ascending dose study which will assess~     the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma~     (Resusix®) in healthy volunteers.~   "
112049|NCT01589653|"~     This trial is conducted in Africa and Asia. The aim of the trial is to compare~     patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in~     type 2 diabetes patients uncontrolled on NPH insulin.~   "
112050|NCT01589640|"~     This is a single center clinical study designed to determine patient satisfaction and the~     effect of the use of artificial tears on tear osmolarity with time after instillation of~     three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and~     Systane Balance).~   "
112059|NCT01589523|"~     The purpose of this research study is to determine the way (mechanisms) by which your defect~     in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of~     vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your~     vitamin absorption and your liver disease. An investigational therapy is one that not~     approved by the United States Food and Drug Administration (FDA) and is being provided to~     you under an Investigational New Drug application from the FDA.~   "
112060|NCT01589510|"~     A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or~     OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion~     of the participating physicians according to their clinical judgment and the local standard~     of medical care.~   "
112061|NCT01589497|"~     Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are~     very small living agents that are spread by coughing and can be killed by taking TB drugs.~     To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months~     and then two drugs for a further 4 months. During the first 2 months patients take~     rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid~     and rifampicin for a further 4 months, making a total of 6 months therapy.~      The investigators want to test a new combination of drugs to see if the investigators can~     treat TB faster in the future. By being in this study, you will not have a shorter course of~     anti-TB treatment; you must still take anti-TB medications for about 6 months.~      Studies in animals have suggested that one of the four drugs, isoniazid, only works for a~     few days and may not be needed after the first two doses of TB treatment to kill the TB~     bacteria. After that its effects wear off to the point that it may even interfere with the~     other drugs. The investigators want to see if stopping isoniazid early, or using~     moxifloxacin, a different drug, instead could treat TB faster. This study will be the first~     time that this type of regimen without isoniazid has been tested in humans. If the~     investigators can show that isoniazid stops working after a few days, the investigators~     could then try to see if they can possibly make a better tuberculosis treatment in the~     future.~   "
112062|NCT01589484|"~     Kidney stone disease affects almost 10% of overall population, often requiring a surgical~     intervention. Currently, shock wave lithotripsy is considered a first-line treatment option~     for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing~     reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several~     factors including stone burden, stone density, stone-skin distance (SSD), and patient's body~     habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography~     scan) performed to assess the presence of residual fragments also impacts on SWL outcome~     analysis.~      We aim to perform a well-controlled prospective evaluation of all variables that may impact~     on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed~     exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of~     an intravenous urography to study renal collecting system anatomy; an imaging exam that is~     not routinely performed anymore for kidney stone patients.~   "
112063|NCT01589471|"~     Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer.~     Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious~     impacts on quality of life in a third of the cases.~      One possible physiopathology hypothesis suggests an ongoing spastic process; different~     mechanisms have been postulated. These include alteration of normal anorectal sensation with~     loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced~     rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy~     or during surgery.~      Current available treatments are often ineffective, highlighting the need for more~     successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine~     release at the neuromuscular junction. It is currently used for the treatment of various~     smooth muscle spastic diseases.~      The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical~     treatment alternative for LARS. The goal of this study is to document the effects of~     intra-rectal BTX-A injections on sphincter function and quality of life of patients with~     LARS.~   "
112064|NCT01589458|"~     Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based~     toothpastes, the present study aim to evaluate F availability in saliva after use of the~     top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers~     will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste~     (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based~     toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated~     saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total~     soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined~     after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using~     an ion selective electrode.~   "
112065|NCT01589445|"~     -  The present study was undertaken to assess the efficacy and safety of two different~          insulin sensitizers (namely Pioglitazone and Metformin) among subjects with type 2~          diabetes mellitus (T2DM) in Bangladesh.~        -  A prospective, double-blind, single group, 'within-subject' designed clinical trial of~          77 diagnosed T2DM patients out of 130 patients with glycosylated haemoglobin (HbA1c)~          ≥7.2±1.5%, aged 46±6.4 years and registered for diabetes treatment in Bangladesh~          Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders~          (BIRDEM) was carried out.~        -  The study was conducted between November 2008 and September 2010.~        -  Baseline data, included case history of the patients,anthropometric measurement,~          biomedical parameters psychosocial factors, were collected from each subject and then~          enrolled to receive treatment with 001 drug once daily for three months, then the~          patients were left for wash out with metformin 850mg once daily for one month; then~          they received 002 drug once daily for further three months.~        -  Dietary chart was remained as before.~        -  DNA was isolated by Chelex method using the primers and control DNA,restriction~          Digestion Enzyme Endonuclease Hae 111 for genotyping PPARγ-(Peroxisome Proliferator~          Activated Receptor gamma)Pro12Pro~             -  (Proline12Proline)/Pro12Ala-(Proline12 Alanine))/Ala12Ala-(Alanine12Alanine).~        -  The blinded drugs were decoded after analyzing results, 001 tablet was pioglitazone (30~          mg once daily) and 002 tablets was metformin (850mg once daily). Bio-medical outcomes~          were measured to assess the efficacy of both the drugs each month. After finishing the~          treatment period the effects of two drugs were compared using SPSS.And the association~          between the pioglitazone drug effects and genetic polymorphism was also assessed.~        -  The metformin effects was assessed also using the response rate of HbA1c <7.0% after 3~          months treatment to the patients.~   "
112066|NCT01589432|"~     People with diabetes can, over time develop nerve damage throughout the body with symptoms~     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.~   "
112069|NCT01589393|"~     Victims of trauma with severe head injury who have bled into their brains are at high risk~     of developing blood clots in their legs. These blood clots can break off and travel through~     the bloodstream to the lungs causing death. Blood thinners can be given to patients to~     prevent blood clots from developing but this can leave patients at risk for additional~     bleeding in the brain causing further damage or death. The earlier blood thinners are~     started the more effective they are at preventing blood clots but some patients with severe~     head injury who have bled into their brains will develop further bleeding even if they do~     not receive blood thinners. Even though a growing body of research has shown that the~     majority of bleeding in the brain stops within the first 24 hours after injury and that it~     is safe to start blood thinners as early as 24 hours after injury, doctors are still waiting~     longer than 4 days to start blood thinners in these patients over concerns of worsening~     bleeding. In Canada, almost half of the patients with severe head injury do not receive~     blood thinners until at least five days after injury. Delays in starting blood thinners~     appear to put patients at increased risk of developing blood clots, unnecessarily. This~     study will compare the benefits of starting low-molecular weight heparin (LMWH), a type of~     blood thinner, early (less than 48 hours) versus the current practice (waiting until the 5th~     day after being injured) in preventing blood clots in patients who have bled into their~     brains after severe head injury. The investigators believe that starting LMWH earlier will~     be more effective in preventing blood clots without worsening any bleeding when compared to~     waiting to start blood thinners. This study is called OPTTTICH (Optimal Timing of~     Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian~     investigator-initiated randomized control trial on blood clot prevention in trauma patients~     with severe head injury who have bled into their brains.~   "
112070|NCT01589380|"~     We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and~     decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse~     LV remodeling favorably in patients with asymptomatic moderate to severe AS.~   "
112071|NCT01589367|"~     Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor~     positive breast cancer patients~      Phase II multicenter 1:1 randomized clinical trial Total 208 patients~      Primary endpoint Clinical response rate~      Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent~     mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy~     Toxicity profile of neoadjuvant letrozole, metformin~   "
112072|NCT01589354|"~     This study evaluates two anaesthetic techniques namely interscalene brachial plexus block~     and intra-articular local anaesthetic injection. Both techniques are currently used for~     providing postoperative pain relief following arthroscopic shoulder stabilisation operation.~     It will be a randomised controlled trial involving 30 patients in two groups.~   "
112073|NCT01589341|"~     This research studies chromosomes in samples from younger patients with neuroblastoma.~     Studying samples of tumor tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~   "
112074|NCT01589328|"~     Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer,~     EPADE-PB~      Purpose~      To determine whether early palliative care integrated with usual oncologic care with~     automated symptom monitoring can improve depression and pain in patients with cancer~   "
112075|NCT01589315|"~     This pilot, open label investigation evaluates the safety and efficacy of a new form of~     electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are~     highly contingent on the intracerebral current paths and current density of the ECT~     stimulus. However, the impedance of the skull and individual differences in skull anatomy~     severely limit the spatial targeting of stimulation, and create marked individual~     differences in intracerebral current density. To address these problems, the investigators~     are exploring various means of overcoming this limitation.~      An approach is to modify the electrical stimulus to induce focal seizures. The most common~     methods of ECT administration in the US use a bidirectional, constant current, brief pulse,~     with large (approximately 3 sq. in. surface area) and identically sized and shaped~     electrodes. In contrast, in this protocol the investigators have coupled unidirectional~     current flow with an electrode geometry involving a small and large electrode that differ by~     more than 3:1 in surface area.~      Unidirectional currents were widely used in ECT during the, 1940's and continue to be used~     in European and American devices today. Transcranial electrical stimulation can be made~     focal by stimulating with an anode-cathode arrangement, with the electrodes differing in~     surface area. The investigators have shown in nonhuman primates the capacity to produce~     focal frontal seizure induction under conditions when a unidirectional current flows from a~     small anterior anode (placed on the forehead over the nasion) to a large posterior cathode~     just anterior to the motor strip. Furthermore, the investigators expect that some, if not~     all, of these seizures do not result in motor convulsions.~      Thirty outpatients referred for ECT will participate. Relative to concurrent reference data~     from our ongoing ECT protocols, the investigators hypothesize that acute and subacute~     adverse cognitive effects of FEAST will be substantially less than those in patients~     receiving state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The~     investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by~     improving the efficiency of the ECT stimulus with the switch to unidirectional current and~     the use of a new electrode geometry, the investigators expect to be able to induce focal~     seizures. The investigators hypothesize that this pilot study will provide evidence that~     this treatment is superior to traditional ECT in having lower dosing requirements and a~     superior side effect profile.~   "
112076|NCT01589302|"~     This is a Phase II, single institution open-label, non-randomized monotherapy study to~     evaluate the clinical efficacy and durable disease control of PCI-32765 administered to~     patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having~     deletion 17p13 independently evaluated.~   "
112077|NCT01589289|"~     The impact of neurological disorders is enormous worldwide, and it is increased in poor~     settings, due to lack of diagnosis and treatment facilities as well as delayed management.~     In sub-Saharan Africa, the few observational studies conducted for the past 20 years show~     that neurological disorders accounted for 7 to 24% of all admissions. Central nervous system~     (CNS) infections were suspected in one third of all patients admitted with neurological~     symptoms, with a specific microbial aetiology identified in half of these. Most CNS~     infections may be considered as severe and treatable diseases, e.g. human African~     trypanosomiasis (HAT), cerebral malaria, bacterial meningitis, CNS tuberculosis etc. If left~     untreated, death or serious sequels occur (mortality rates were as high as 30% in the above~     mentioned studies), but the outcome may be favourable with timely and appropriate~     management.~      In poor settings, such conditions should be targeted in priority in the clinical~     decision-making process. Unfortunately, most neuro-infections present with non-specific~     symptoms in their early stages, leading to important diagnostic delays. Moreover, they~     require advanced diagnostic technology, which is not available in most tropical rural~     settings: here, you have to rely on clinical judgment and first-line laboratory results,~     whose confirming or excluding powers are limited or unknown. Several rapid diagnostic tests~     (RDTs) have been recently developed for conditions like malaria or HIV, but their diagnostic~     contribution has not been evaluated within a multi-disease approach.~      Thus, this research aims at improving the early diagnosis of severe and treatable neglected~     and non-neglected infectious diseases which present with neurological symptoms in the~     province of Bandundu, Democratic Republic of Congo (DRC), by combining classic clinical~     predictors with a panel of simple point-of-care rapid diagnostic tests.~      The evaluation of existing algorithms and elaboration/validation of new guidelines will be~     described in a subsequent protocol.~   "
112078|NCT01589276|"~     The aim of present study was to evaluate the clinical course after emergency ventral hernia~     repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk~     factors for emergency repair.~   "
112094|NCT01589068|"~     The proposed clinical studies will analyze the interactions between progesterone, nicotine,~     fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and~     cardiovascular measures. It is hypothesized that the administration of progesterone at a~     dose that mimics luteal phase levels in normal cycling women will diminish the positive~     subjective effects of nicotine, as has been consistently observed for cocaine. This novel~     approach could have direct implications for facilitating smoking cessation treatment in~     women of reproductive age~   "
112079|NCT01589263|"~     Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that~     affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms~     (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life~     significantly, and are costly.~      his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled,~     parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per~     day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS [American~     Urologic Association Symptom Score (AUASS) equal to or greater than 8] associated with BPH.~     A total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers~     will include only males who are greater than 50 years of age and diagnosed with LUTS~     associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs~     Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or~     ethnicity.~   "
112080|NCT01589250|"~     Use of risk scoring systems in the assessment of patients presenting with upper~     gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify~     the system of choice, but the majority of these are characterized by retrospective designs,~     small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this~     study was to identify the optimal scoring system.~   "
112081|NCT01589237|"~     This study was to determine long-term safety and tolerability, and continued efficacy in~     lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS)~     (HLP type I).~   "
112082|NCT01589224|"~     Coronary MDCT (multi-detector computed tomography) has been useful screening imaging~     modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well~     as various inflammatory markers have been known as direct regulators of atherosclerosis.~     Therefore, the investigators examine the correlation of various metabolic risk factors~     including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT~     in apparently healthy people.~   "
112083|NCT01589211|"~     To investigate the effectiveness of a smoking cessation intervention of two sessions (120~     min at a time) in a group setting on the basis of Motivational Interviewing (MI) and~     important elements of Cognitive Behavioural Therapy (CBT). According to national and~     international guidelines patients are advised to quit and pharmacologically supported with~     one of the established first line smoking cessation treatments.~   "
112084|NCT01589198|"~     The purpose of this study is to learn more about asthma in people who are not~     well-controlled with current asthma medication (refractory asthma). The investigators will~     compare data from refractory asthmatic patients here at National Jewish Health to mild~     asthmatics subjects and to people without asthma. Study experiments involve looking at~     samples from all 3 groups and comparing them at a molecular level. These laboratory~     experiments may help identify subtypes of refractory asthmatics that require different~     treatments.~   "
112085|NCT01589185|"~     The objectives of this study are to assess the safety, tolerability, pharmacokinetics,~     pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by~     Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in~     addition of standard of care antibiotic treatment.~   "
112086|NCT01589172|"~     The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to~     the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and~     after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities~     of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin~     time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio~     (INR).~   "
112087|NCT01589159|"~     This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and~     safety study. Eligible patients are enrolled in a single group. The investigators propose to~     determine the efficacy and safety of low-dose metronomic chemotherapy with~     Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with~     Anthracyclines and/or Taxanes.~   "
112088|NCT01589146|"~     Overall, only limited evidence exists regarding the clinical benefit of antithrombotic~     prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of~     venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ~     concerning study design, site of cancer, regimens for antithrombotic prophylaxis and~     reported incidence of VTE.~      The aim of this multicenter, randomized study is to assess the clinical benefit of extended~     (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for~     colorectal cancer.~   "
112089|NCT01589133|"~     The purpose of this study is to assess the consistency of the results of irregular antibody~     screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent),~     and the consistency of the results of irregular antibody screening with investigational~     reagent on serum and plasma from same patients.~   "
112090|NCT01589120|"~     The purpose of this study is to compare the decision making of subjects with advanced CHF~     having a verbal discussion about goals of care compared to subjects using a video.~   "
112091|NCT01589107|"~     To demonstrate that clinical surrogates of SICU patients who view a video decision aid in~     addition to receiving written and verbal information about procedures and life sustaining~     therapy in the SICU make more informed decisions than patients and clinical surrogates who~     receive written and verbal information alone.~   "
112092|NCT01589094|"~     The purpose of this study is to find out if standard chemotherapy (gemcitabine and~     cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can~     help shrink the tumor better than standard chemotherapy given on a standard treatment~     schedule before the patient undergoes surgery for bladder cancer.~   "
112093|NCT01589081|"~     The proposed clinical studies will analyze the interactions between progesterone, nicotine,~     alterations in endocrine hormones, mood and cardiovascular measures. It is hypothesized that~     the administration of progesterone at a dose that mimics luteal phase levels in normal~     cycling women will diminish the positive subjective effects of nicotine, as has been~     consistently observed for cocaine. This novel approach could have direct implications for~     facilitating smoking cessation treatment in women of reproductive age~   "
112117|NCT01588769|"~     It is the primary objective of this study to show safety and tolerability for administration~     of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a~     secondary objective to establish if any indications of positive therapeutic or palliative~     effects may be observed.~   "
112095|NCT01589055|"~     Clinical studies are proposed to analyze the interactions between nicotine, alterations in~     endocrine hormones, mood and cardiovascular measures. The studies are designed to examine~     the contribution of gender and menstrual cycle phase. It is hypothesized that analysis of~     nicotine's rapid hormonal, cardiovascular and subjective effects will be important for~     developing novel biologic approaches to treatment for nicotine abuse and dependence as well~     as advancing understanding of the neurobiology of nicotine reinforcement.~   "
112096|NCT01589042|"~     To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the~     effectiveness of the device for use during percutaneous transluminal angioplasty (PTA)~     procedures.~   "
112097|NCT01589029|"~     The pilot study evaluates the efficacy and safety of Canakinumab (ILARIS®) in subjects with~     proliferative diabetic retinopathy secondary to type 1 and 2 diabetes. Ten subjects will be~     enrolled to receive 150 mg Canakinumab (ILARIS®) by subcutaneous injection. Beginning on day~     0, each subject will receive a subcutaneous injection of study drug every 8 weeks for 16~     weeks, a total of 3 injections. All subjects will undergo regular follow-up assessments~     every 8 weeks through 24 weeks. Fluorescein angiography (FA) is repeated every 8 weeks. In~     case of progression of retinal neovascularization on FA panretinal laser photocoagulation is~     administered as rescue therapy. The primary outcome is the regression of retinal~     neovascularizations (NVE and NVD) in FA at 24 weeks. In addition to key secondary outcomes~     including regression of diabetic macular edema, change in best-corrected visual acuity,~     change in HbA1c levels and change in markers of systemic inflammation. Safety will be~     assessed by measurements of vital signs, clinical laboratory assessments, and the recording~     of adverse clinical events.~   "
112098|NCT01589016|"~     The purpose of this study is to determine the predictive value of a single serum~     determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in~     Vitro Fertilization (IVF) cycles, in both native and donated oocytes.~   "
112099|NCT01589003|"~     The current study proposes to investigate the impact of a low glycaemic index (GI),~     fortified toddlers milkpowder on mood, behaviour and cognitive function in young children.~   "
112100|NCT01588990|"~     This open-label, prospective, single-arm, multicenter study will evaluate the relationship~     of the markers of inflammation and progression-free survival in patients with previously~     untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment:~     XELOX plus Avastin (bevacizumab), or mFOLFOX6 plus Avastin administered until first disease~     progression. Patients will then continue with Phase B treatment: FOLFIRI plus Avastin until~     second disease progression. The anticipated time on study treatment is 4 years.~   "
112101|NCT01588977|"~     The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The~     creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study~     demonstrated tibial subchondral microfractures in the group antegrade tibial tunnel unlike~     group retrograde tibial tunnel. To our knowledge, no clinical evaluation was performed.~     The investigators hypothesize that retrograde drilling will cause less local bone injury~     than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.~   "
112102|NCT01588964|"~     In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the~     re-challenge with a compound of platinum-based, or a treatment with carboplatin in~     combination with paclitaxel , determines a rate of clinical response similar to the primary~     treatment, which is all the more important as the longer the time to progression from the~     primary therapy.In the clinical setting there are many studies that have shown activity of~     oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have~     shown clinical efficacy of the combination carboplatin / docetaxel in the first line~     oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from~     studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis~     including approximately 7000 patients in advanced stages of disease, that the extent of~     cytoreduction is the most powerful determinant of survival.The role of secondary surgical~     cytoreduction in case of recurrent disease has yet to be determined because of the lack of~     prospective randomized clinical studies that may highlight the superiority of such~     aggressive treatment.The combination of aggressive cytoreductive surgery and hyperthermic~     intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a~     prolonged time to progression and disease-free survival in patients with ovarian cancer.~     However, these studies were conducted on groups of patients with very different among~     themselves and with other drugs, it is difficult to draw definitive conclusions.Given the~     activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2~     clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive,~     treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative~     intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and~     docetaxel systemically every 21 days.~   "
112103|NCT01588951|"~     The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of~     patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to~     the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission~     (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell~     transplantation (SCT).~   "
112104|NCT01588938|"~     This prospective study at MAMC evaluates the utility of a rigid pelvic external~     immobilization compared to limited immobilization using a novel real-time localization~     system of the prostate. The sample population will include patients referred to the~     radiation oncology services of both facilities for definitive treatment of prostate cancer.~     The study will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy~     fractions.~      Subjects will have Beacon® Transponders implanted into the prostate to more precisely~     localize the position of the organ during radiation therapy. They will be randomized to~     rigid pelvic immobilization using a Vac-Lok® system or limited immobilization with a band~     around the patient's feet. They will then undergo radiation therapy planning with standard~     planning target margins. The Calypso® 4D Localization System will monitor, in real time, the~     position of the prostate target and adjust radiation treatments as required to ensure~     accurate treatment of the prostate gland. The time of, the number, and extent of adjustments~     will be recorded for analysis.~      Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization~     is not necessary when using real-time, state-of-the-art motion tracking of the prostate.~   "
112105|NCT01588925|"~     The objective of the present study is to investigate the effect dexamethasone and hyaluronic~     acid have on hearing preservation~   "
112118|NCT01588756|"~     The purpose of the study is to validate a new reference marker for evaluation of renal~     function (glomerular filtration rate).~   "
112173|NCT01588015|"~     This randomized phase I trial studies the side effects of vaccine therapy in preventing~     cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor~     stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body~     build an effective immune response and prevent or delay the recurrence of CMV infection in~     patients undergoing donor stem cell transplant for hematological malignancies.~   "
112106|NCT01588912|"~     Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B~     include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American~     Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European~     association for the Study of the Liver (EASL) Treatment Guidelines recommend the~     administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine~     has low antiviral potency and high incidence of mutation in long-term administration~     compared to Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK),~     side effects including myositis/myopathy and much mutation in the long-term administration.~     Globe study demonstrated Telbivudine had more excellent antiviral potency than Lamivudine,~     which was also comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice~     of treatment drugs can be limited due to the mutation rate of 25% for 2 years. However, the~     analysis of Globe study results showed that 2-year treatment progress was very good in~     patient who showed virologic response at 24 weeks after the initiation of treatment and that~     high antiviral potency and low mutation rate were observed when the Telbivudine roadmap~     strategy (in the event that virologic response is shown at 24 weeks, telbivudine monotherapy~     is maintained and in the event that virologic response is not shown, tenofovir add-on~     therapy is done) recently implemented and announced in 2011 Asian Pacific Association for~     the Study of the Liver (APASL) was applied. However, the study was single arm study, which~     restricted the comparison between Entecavir and Tenofovir monotherapy groups. Therefore,~     this study intends to compare the anti-viral effect and mutation rate between Entecavir~     0.5mg monotherapy group and Telbivudine roadmap strategy group in patients with~     HBeAg-positive chronic hepatitis B through a randomized study.~   "
112107|NCT01588899|"~     The purpose of this study is to demonstrate safety and effectiveness of the Philips~     Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for~     treatment of uterine fibroids in a Chinese population.~   "
112108|NCT01588886|"~     Chronic kidney disease is a severe medical problem in Taiwan public health issue, which the~     highest incidence and prevalence rate in the world.Proton pump inhibitors may increase the~     risk of pneumonia appearance, which were caused by profound irreversible gastric acid~     suppression. The study purpose was to characterize difference of developing pneumonia in~     chronic kidney disease of prior use proton pump inhibitors.~   "
112109|NCT01588873|"~     The main aims of this study are:~        -  to investigate and compare the effects of long lasting use (59 weeks) of vaginal and~          oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid~          profile, and serum levels of SHBG and hs-CRP in women with PCOS.~        -  to compare the metabolic effects of oral and vaginal combined contraceptives and to~          find out whether oral or transvaginal contraceptive can be recommended to a particular~          group of women, for example in women with increased metabolic risks.~        -  to clarify whether the unfavourable effects of combined contraceptives diminish with~          time (after use of one year).~   "
112110|NCT01588860|"~     Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and~     constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High~     prevalence in southeast and eastern Asia has been observed. At present, the cellular and~     molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.~      The RAS gene product has a key role in controlling cell growth and differentiation through~     its intrinsic GTPase activity. Point mutations that activate the RAS protein and its~     downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the~     RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals.~     Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer~     and lung cancer. Studies from European and Japanese groups have recently described that~     activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma~     of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF~     mutation in the same tumor as well as the results from Thailand. In this study, the~     investigators hypothesize copy number changes rather than genetic mutation of either KRAS or~     BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary~     tracts.~   "
112111|NCT01588847|"~     Studies in animals and retrospective studies in humans show that regional anesthesia reduces~     metastatic cancer dissemination.~      The investigators hypothesize that in patients suffering from malignant melanoma who have to~     undergo radical inguinal lymph node dissection immune function will be less compromised and~     long term survival will be superior when spinal anesthesia is compared to general~     anesthesia.~   "
112112|NCT01588834|"~     The investigators hypothesize that knowledge of the functional behavior of areas of~     mammographic density will enable more specific identification of dense tissue at-risk for~     breast cancer, ultimately providing predictive information on an individual's risk of~     developing breast cancer.~   "
112113|NCT01588821|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not approved the drug for this type of cancer, or for~     any use outside of research studies.~      When cancer spreads from the primary tumor, one of the most commons sites it spreads to is~     bone. When cancer spreads to bone there can be significant symptoms such as pain.~      Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the~     growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been~     studied or is being studied in research studies as a possible treatment for various types of~     cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney~     cancer.~      Previous clinical research studies indicate that cabozantinib may also have activity against~     cancer once it has spread to the bones.~      The purpose of this study is to find out if cabozantinib is effective in treating cancer~     that has spread to the bone.~   "
112114|NCT01588808|"~     In the present study, the effects of 5 days of lower limb immobilization with or without~     twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be~     determined. A young group will be included to compare the changes in muscle mass and muscle~     fiber characteristics between young and old men.~   "
112115|NCT01588795|"~     The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized,~     controlled study of the effectiveness of renal denervation in addition to standardized~     medical treatment compared to medical treatment alone in diabetic subjects with diabetic~     nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using~     the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy~     through the luminal surface of the renal artery.~   "
112116|NCT01588782|"~     The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for~     drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is~     co-administered with abiraterone acetate in healthy adult men.~   "
112119|NCT01588743|"~     It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to~     impairment in islet β-cell function and development of insulin resistance. A growing body of~     evidence also indicates that this impairment inβ-cell function and insulin action could be~     restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this~     study, we are determined to use the golden standard of insulin sensitivity evaluation in~     vivo—hyperinsulinemia euglycemic glucose clamp—to estimate insulin resistance improvement in~     patients before and after intensive insulin therapy, investigate first phase insulin~     secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin~     secretion resulting from normalization of plasma glucose levels in both lean and obese~     patients by insulin pump therapy.~   "
112120|NCT01588730|"~     The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to~     static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).~   "
112121|NCT01588717|"~     The study consists of measurement of antidepressant-induced excessive sweating and its~     treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which~     will be added to the antidepressant. This is an open-label study (no placebo group or~     concealment of the nature of the treatment) that will last 8 weeks, including two weeks of~     baseline measurement without treatment with the study medication followed by six weeks of~     treatment with the study medication. The study is pilot study by Dr. Rajnish Mago that is~     based on the hypothesis that glycopyrrolate will be effective in reducing the severity of~     excessive sweating caused by antidepressant treatment, and will have minimal side-effects.~   "
112122|NCT01588704|"~     The prognosis of patients with unresectable, locally advanced non-small cell lung cancer~     (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The~     newer drug regimens can be expected to improve survival in this subset of NSCLC patients.~     Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially~     for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is~     bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF).~     Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy~     may change the previous treatment modality. It allows some lung cancer patients to be~     downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be~     improved.~   "
112123|NCT01588691|"~     Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury.~     This study will specifically examine patients with mild traumatic brain injury (TBI) who~     have persistent cognitive impairments lasting one year or longer. Neuropsychological testing~     will occur to confirm the diagnosis.~   "
112124|NCT01588678|"~     DS-3078a will be evaluated as a single agent in subjects with advanced solid tumor~     malignancies or lymphomas refractory to standard treatment or for which no standard~     treatment is available.~   "
112125|NCT01588665|"~     The two specific aims of this study are 1) to assess the relative contributions of two major~     maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron~     to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental~     transfer of these two iron sources in pregnant women and adolescents during the last~     trimester of pregnancy.~   "
112126|NCT01588639|"~     This is a prospective, multi-center, open-label, non-interventional, 12-week study in people~     with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N,~     SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term~     study insulins will be used in this protocol for these drugs and combinations.~   "
112127|NCT01588626|"~     The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active~     metabolite, safety, tolerability of AZD6140 following single administration in healthy male~     Japanese volunteers.~   "
112128|NCT01588600|"~     The effects of a dietary fiber on hunger and food intake will be tested in men and women.~     Participants will receive fiber as part of a breakfast meal on two occasions. On another~     occasion, participants will receive the same breakfast, without added fiber. Their feelings~     of hunger and fullness will be measured over the day. They will be offered lunch, dinner and~     an evening snack and how much they eat will be recorded. It is expected that the fiber~     supplement will enhance their feelings of satiety and reduce the amount they eat over the~     day.~   "
112129|NCT01588587|"~     Recently, DPP-IV inhibitors are used as a novel way to augment the incretin system and one~     of the newest classes of medications in the treatment of type 2 diabetes mellitus (T2DM).~     Since the DPP-IV inhibitor was first used, about 5 years have passed in USA. However, there~     were no major side effects including occurrence of cancers. The main mechanism for DPP-IV~     inhibitors is due to suppress the function of DPP-IV activity. As it is known that the~     suppressed DPP-IV activity is a marker for early diagnosis of cancers, the reason of~     disassociation is not clear.~      Activation of receptor for advanced glycation endproduct (AGE) is related to sideration of~     cancers. Meanwhile, the DPP-IV inhibitors may be related to inhibit the activation of~     receptor for AGE (RAGE). Therefore, DPP-IV inhibitors may work as a cancer protective agent~     in diabetes by blocking the AGE-RAGE axis.~      However, it is not demonstrated why DPP-IV inhibitors have no side effect of occurrence of~     cancer via blocking the activation of AGE-RAGE.~      The investigators examined effect of DPP-IV inhibitors on frequency of cancers and the~     underlying mechanism using AGE and RAGE before and 5 years after administration of DPP-IV~     inhibitors in Japanese patients with T2DM.~   "
112130|NCT01588574|"~     The purpose of this study is to determine the Optimal dose for safety and efficacy in the~     treatment of cervical dystonia.~   "
112131|NCT01588561|"~     Clinical studies are proposed to measure the covariance between nicotine-induced changes in~     endocrine, subjective and cardiovascular effects and the temporal concordance with increases~     in serum nicotine and cotinine levels. Possible gender and menstrual cycle phase influences~     on the effects of nicotine on hypothalamic-pituitary-adrenal axis (HPA) and~     hypothalamic-pituitary-gonadal axis (HPG) hormones have not been clearly delineated.~     Accordingly, the investigators propose to compare the acute effects of nicotine in men and~     women, and to study women at the follicular and the luteal phases of the menstrual cycle.~   "
112132|NCT01588548|"~     The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a~     maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when~     given daily to patients with advanced solid malignancies including malignant lymphoma~   "
112137|NCT01588483|"~     Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of~     age. The disease has limited mortality, mostly due to the development of aortic aneurysms,~     leading to dissection and rupture. The probability to develop this complication is 17 x~     higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in~     patients with GCA when compared with a control group. Therefore, follow-up of the aortic~     diameter in patients with GCA is part of good clinical practice. Previous retrospective~     research showed a link between FDG-uptake at the level of the thoracic aorta, on~     positron-emission-tomography (PET) at the time of diagnosis, and the increase of diameter~     and volume of the thoracic aorta during follow-up (on computed tomography (CT)).~      The purpose of this prospective study is to follow-up on the aortic diameter, and to~     correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to~     define a group of patients at high risk to develop an aortic aneurysm, already at the time~     of diagnosis.~   "
112138|NCT01588470|"~     The purpose of this study is to examine the existence of heart abnormalities in patients~     with diabetes and the effect of pioglitazone in correcting these abnormalities.~   "
112139|NCT01588457|"~     The purpose of this study is to compare which of the two mood stabilizers (drugs that help~     to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is~     more effective in patients with bipolar disorder over 26 weeks. The study will also compare~     if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus~     lithium or divalproex used with lamotrigine is more effective when symptoms of depression~     develop.~   "
112140|NCT01588444|"~     The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft~     (FDBA) materials in the preservation of alveolar bone following extraction of non-molar~     teeth. The primary objective is to histologically evaluate and compare the healing of~     extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for~     ridge preservation.~   "
112141|NCT01588431|"~     Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with~     various combinations of radiation and chemotherapy. This study aims to evaluate the rate of~     complete responses with induction therapy (primary endpoint) and progression-free survival,~     overall survival and objective response rates of docetaxel, cisplatin, cetuximab, and~     bevacizumab (TPE-A) followed by radiation therapy, cisplatin, cetuximab, and bevacizumab~     (XPE-A). Also, the investigators plan to investigate a panel of EGFR and angiogenesis~     biomarkers in pre-and post- treatment tumor biopsies. Finally, the investigators will~     evaluate the associated treatment toxicities and the quality of life.~   "
112142|NCT01588418|"~     This research study will examine brain glucose metabolism after an overnight fast to~     determine the effect of exenatide on brain glucose metabolism and lipid metabolism.~   "
112143|NCT01588405|"~     This multi-center, open-label study will assess the tolerability and safety of transitioning~     subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)~     or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)~     tablets).~      This study will consist of an in-hospital transition phase, dose optimization/evaluation~     phase, and follow up phase.~   "
112144|NCT01588392|"~     The purpose of this study is to examine if short bouts of structured physical activity~     implemented within the classroom setting as part of designated gross-motor playtime will~     increase preschool-age children during-school physical activity level.~   "
112145|NCT01588379|"~     The purpose of this study is to examine the feasibility and efficacy of a 12-week~     afterschool afro-centric dance physical activity program for daughters and mothers on the~     physical activity level of African-American girls.~   "
112146|NCT01588366|"~     This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of~     LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study~     will image the liver using magnetic resonance imaging (MRI) and magnetic resonance~     spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes~     mellitus, when they take LY2409021 to see if liver changes happen at the same time as~     changes in blood tests. This study is approximately 11 weeks long, not including screening.~     A screening appointment is required within 28 days prior to the start of the study.~   "
112147|NCT01588353|"~     To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.~      To determine plasma concentration after the first injection of AK160 in patients with~     Dupuytren's Contracture.~   "
112148|NCT01588340|"~     The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring~     sedation to ultrasound in the assessment of hydronephrosis.~   "
112149|NCT01588327|"~     The ability to explain bleeding or clotting complications in patients treated with~     dabigatran remains challenging. In addition, there is limited data on how coagulation tests~     perform in patients treated with therapeutic doses of dabigatran. Predicted responses of~     coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding~     abnormal responses to dabigatran. The purpose of the study is to define a therapeutic~     reference range for peak and trough coagulation tests in patients taking FDA approved doses~     of dabigatran and to determine which tests may be most clinically useful for monitoring~     dabigatran.~   "
112150|NCT01588314|"~     The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling~     peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid~     analgesics. The investigators are conducting a randomized, double-blind, placebo controlled,~     single center, cross-over study. The primary endpoint is percent reduction in patients' use~     of hydrocodone-acetaminophen.~   "
112174|NCT01588002|"~     This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study~     will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose~     ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive~     multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period~     2, all subjects will receive multiple oral doses of the combination danoprevir with~     ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.~   "
112527|NCT01583309|"~     Convective therapies have been proposed for improving chronic dialysis patient outcomes,~     including intradialytic symptomatic hypotension.~      To evaluate the frequency of sessions with intradialytic symptomatic hypotension in~     different types and doses of convective therapies compared with low-flux hemodialysis (HD),~     the investigators performed a multicentre, open-label, randomized controlled trial.~   "
112151|NCT01588301|"~     Scientific Context:~      High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.~     Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's~     well-known that this test has significantly contributed to the reduction of mortality and~     morbidity due to cervical cancer. In France, it now seems that the screening strategy could~     be optimized. The two main ways are to reach the 7 million underscreened women (organized~     screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA~     testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA~     testing could be a relevant screening option: this technique appears reliable and it could~     allow to reach women who are never or seldom screened. The performance of the SCVS to detect~     cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.~      The goal of this study is to compare the attitudes of women not attending organized cervical~     cancer screening face to different strategies: further invitation to make a cervical smear~     or kit for self-collected vaginal sample sent at home.~      Description of the project :~      Nine months after a primary invitation to make a cervical smear, a random sample of 6000~     women not attending organized cervical cancer screening will be randomly assigned to one of~     the following arms:~        -  Intervention arm 1:~      Women will receive a further invitation to make a cervical smear~        -  Intervention arm 2:~      Women will be directly sent the kit for self-collected vaginal sample at home. The women who~     will send the self-sample to the laboratory for analyse will receive their results at home~     as well as their general practitioner if the HPV DNA test is positive (infection by a~     high-risk HPV).~      For them who will have a HPV DNA test positive, it will be necessary to complete the~     screening action with a cervical smear. That's why those women will receive an invitation to~     make a cervical smear if they won't do it during the 9 months following the first mail.~        -  Control arm: Those women will receive complete information about the study, the main~          results and the screening recommendations at the end of the study.~   "
112152|NCT01588288|"~     The investigators will dose galectin 3 in plasma and water rinse of the needle aspiration~     biopsy in patients with thyroid nodules. The investigators aim to show that preoperative~     dosage of the galectin 3 could provide good diagnosis of malignant versus benign thyroid~     cancer.~   "
112153|NCT01588275|"~     The purpose of this study is to compare the cost-effectiveness and effectiveness of~     mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP)~     therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).~   "
112154|NCT01588262|"~     A life threatening disease such as cancer may lead to post traumatic stress disorder, and~     even when reporting low levels of side-effects from cancer disease and treatment, 80% report~     high levels of stress symptoms. The purpose of the present randomised controlled trial is to~     examine the psychosocial effects of a stress management intervention based on cognitive~     behaviour therapy and with focus on increased physical activity in patients with various~     cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is~     possible to study the level and intensity of stress management intervention required to~     achieve increased well-being. A cost-utility analysis will also be performed. 300 adult~     patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or~     lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland~     University Hospital, will be consecutively included in the prospective intervention study.~     The patients will be randomized to intervention or control. In step 1, all patients in the~     intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically~     significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by~     Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression~     Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There~     will also be a focus on motivating to increase physical activity level. Both the~     intervention (I) and control group (C) are allowed to take part in the common rehabilitation~     program with patient education and physical training. Data will be collected with~     self-reported standardized questionnaires. Objectively measures of physical activity level,~     sleep and daily energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point~     is at inclusion and than after 6 week, 4, 8, 12 and 24 month.~   "
112155|NCT01588249|"~     Cough is a frequent symptom in children and infants and is one of the most common reasons~     parents visit a healthcare provider for their child. The US Food and Drug Administration has~     issued a warning that over-the-counter cough and cold medicines including antihistamines,~     decongestants, anti-tussives, and expectorants should not be administered to children~     younger than 2 years of age due not only to lack of proven efficacy, but also because of~     important safety concerns. A product that has been used in alternative medicine for cough is~     maple syrup. Although no studies have formally evaluated the use of maple syrup for~     nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some~     relief from cough in children. A novel formulation of pasteurized maple cough syrup, when~     compared to placebo, should provide superior relief on nocturnal cough and the sleep~     difficulty associated with URI in children under 12 months and sleep difficulty of their~     parent/caregiver.~   "
112156|NCT01588236|"~     The purpose of this study is to further assess the efficacy, safety and dose-response of~     KYG0395 in the treatment of primary dysmenorrhea.~   "
112157|NCT01588223|"~     The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that~     can predict endometrial receptivity.~   "
112158|NCT01588210|"~     The hypothesis of this study is that the concentration of fluoride in oral interproximal~     fluids would increase more after using high-viscosity GIC as pit and fissure sealant,~     compared to Resin-Based sealants containing fluoride and RB sealants without fluoride~     content. To validate this hypothesis a randomized clinical trial was designed and performed~     in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo~     after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants~     containing fluoride and RB sealants without fluoride content.~   "
112159|NCT01588197|"~     The purpose of this study is to determine whether real-time functional magnetic resonance~     imaging may be a viable treatment for chronic pain in the future.~   "
112160|NCT01588184|"~     This single-arm, open-label, multicentre extension study will provide continued Avastin~     [bevacizumab] therapy to patients with solid tumours who were previously enrolled in a~     Roche/Genentech sponsored study and who derived benefit from the Avastin therapy. Patients~     will receive the same dose and regimen as used in the previous parent trial and continue~     this treatment until disease progression or unacceptable toxicity.~   "
112161|NCT01588171|"~     The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH~     (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for~     venous thrombosis.~   "
112175|NCT01587989|"~     This multicenter study with a randomized, double-blind, parallel-group phase will evaluate~     the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate~     versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis,~     with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg~     intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients~     with a good/moderate EULAR response will then be randomized to receive either~     RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12~     weeks. Anticipated time on study treatment is 6 months.~   "
112176|NCT01587976|"~     The purpose of this trial is to study health related quality of life (HQoL)after resection~     of colorectal liver metastases combined with perioperative chemotherapy. The investigators~     want to study if an aggressive, life prolonging and multimodal treatment can be defended~     from a quality of life perspective.~   "
112162|NCT01588158|"~     Adequate pain relief has been a priority of the Joint Commission and is featured on national~     inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction~     with pain relief in the United States, a great deal of emphasis has been placed on opioid~     pain medications. Some of this emphasis on opioid pain medication is driven by the~     pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.~      There is evidence that the pain is the fifth vital sign campaign of the Joint Commission~     led to an increased incidence of prescription of opioids, but there is less evidence of~     improved satisfaction with pain relief. There is some evidence of an increase in~     opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has~     the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the~     Emergency Department for opioid overdose doubled between 2004 and 2008.~      Patients in other countries take far less opioid pain medication and are equally satisfied~     with pain relief. For instance, Lindenhovius et al. found in a retrospective study that~     Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture~     surgery and have comparable or better satisfaction with pain relief than American patients,~     most of whom take oxycodone. That study was repeated prospectively (unpublished) and~     confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine~     use after a femur fracture demonstrated that American patients used far more than Vietnamese~     patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief.~     These sociological differences are striking and suggest strongly that personal factors may~     be the most important determinant of satisfaction with pain relief.~      It is our impression that most American hand surgeons give patients a prescription for an~     opioid pain medication after carpal tunnel release, and that is certainly true in our~     practice. This seems to be based primarily on the outliers, and intended to avoid~     confrontation with patients that desire opioids; however, most patients take little or no~     narcotic pain medication, and many who do use the opioids complain of the side~     effects—nausea and pruritis in particular. It is therefore not clear whether routine opioids~     is the optimal pain management strategy after carpal tunnel release. In the study of Stahl~     et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal~     tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use~     acetaminophen or other pain medication at all after the operation.~      Our aim is to determine if there is a difference in satisfaction with pain relief between~     patients advised to take opioids compared to patients advised to use over the counter~     acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to~     determine if personal factors account for more of the variability in satisfaction with pain~     relief than opioid strategy.~   "
112163|NCT01588145|"~     The main objective of this study is to evaluate the safety and tolerability of HM61713.~   "
112164|NCT01588132|"~     In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of~     Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical~     evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and~     low bleeding potential in healthy human subjects.~   "
112165|NCT01588119|"~     Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban,~     Edoxaban) in routine treatment will recorded in this register. Within this register a~     characterization of patients (with regard to demography and indication) and therapy (with~     regard to medication, dose and duration) will be done. On basis of defined clinical relevant~     end points the long-term efficacy and safety will be evaluated.~   "
112166|NCT01588106|"~     The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with~     AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE)~     enables behavioral changes that may lead to improvement in glycemic control, expressed as a~     reduction in HbA1c as primary endpoint.~      Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be~     trained in using the devices and return every 3 months until month 9 after baseline.~   "
112167|NCT01588093|"~     Hormonal disturbances in the GH-IGF-I axis are considered important for the deterioration of~     glycemic control in T1DM particularly in adolescents. In addition it may have direct~     implications on the development of insulin resistance and long-term complications.~      The Investigators hypothesis is that low circulating IGF-I and compensatory hyper-secretion~     of GH, in the presence of peripheral insulin excess, results in increased local IGF-I~     expression explaining both the deterioration in metabolic control and the increased risk for~     microvascular complications. Correction of imbalance in circulating and tissue-specific~     levels of IGF-I could lead to both better early metabolic control and to prevention of early~     diabetic complications in type 1 diabetic (T1DM) patients.~      Aim of the present study is to validate the microdialysis technique as a useable tool to~     predict local biological effects of IGF-1 and to understand the pharmacokinetics of local~     IGF-I actions after sc injection of Increlex in type 1 diabetic patients.~   "
112168|NCT01588080|"~     When babies are born premature, they often need help with their breathing. The equipment~     used to help them breathe is not very comfortable and they sometimes need to be put on a~     specialized breathing machine with a tube into their lungs. The breathing machine or~     ventilator can be damaging to the newborn's lungs and more damage can occur the longer the~     newborn stays on a ventilator leading to chronic lung disease later in their lives. A new~     device called neurally adjusted ventilatory assist or NAVA is available that the~     investigators believe may be more comfortable for the premature newborn and may help the~     baby come off breathing support sooner. When using this device, babies may not need to be~     put on a ventilator and can avoid the lung damage associated with the breathing tube and the~     ventilator. The objective of this pilot study is to compare this new breathing device called~     NAVA, to the equipment that is currently being used, called SiPAP, to support premature~     newborn's breathing after birth without a breathing tube. The investigators hope to show~     that with this new technology, premature newborns that are having a difficult time~     breathing, will come off breathing support sooner compared to the breathing machines that~     are currently being used. The hypothesis for this proposed study is that improved synchrony~     with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid~     intubation.~   "
112169|NCT01588067|"~     This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD)~     patients undergoing lower extremity revascularization to describe the population and assess~     comparative effectiveness of endovascular therapy versus surgery. In addition, this study~     will conduct a prospective cohort study of patients treated medically or undergoing lower~     extremity revascularization at the VA and Kaiser Colorado to compare changes in health~     status.~   "
112170|NCT01588054|"~     The purpose of this study is to define clinical and demographic features within the~     population suffering from cervical deformity to assist health professionals to make~     important treatment decisions.~   "
112171|NCT01588041|"~     The purpose of this study is to investigate the use of optical coherence tomography imaging~     integrated with an operating microscope (MIOCT) in ophthalmic surgeries.~   "
112172|NCT01588028|"~     CH5424802 is a newly invented, selective oral ALK inhibitor. In the Phase I portion, the~     goal is to determine the following: dose limiting toxicity, the maximum tolerated dose,~     pharmacokinetic (PK) parameters, and the recommended dose.~   "
112177|NCT01587963|"~     It has been shown that the stress that occurs during trauma, infection and/or shock depletes~     many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to~     further complications. The purpose of this study is to determine the effectiveness of high~     doses of Vitamin C in critically ill patients.~   "
112179|NCT01587937|"~     Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic~     resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in~     hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has~     published guidelines stating that all hospitals should develop an institutional program to~     enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic~     stewardship audit-and-feedback intervention for all patients reaching their third or tenth~     day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic~     use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The~     investigators hypothesize that this intervention will result in similar benefits outside of~     the intensive care unit, and so expanded the intervention to non-ICU medical and surgical~     wards. To increase the rigor of our program evaluation, the roll-out was conducted in a~     stepped-wedge randomized controlled design.~   "
112180|NCT01587924|"~     This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center~     study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from~     stable rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia~     associated with chronic kidney disease. The study consists of a screening phase of 2 weeks,~     a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study~     eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with~     total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening~     visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and~     Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic~     kidney disease after switching from a stable maintenance dose of recombinant human~     erythropoetin (rhEPO).~   "
112181|NCT01587911|"~     Assessing 5 different milk derived proteins versus placebo for appetite regulation and~     satiety, delivered via shake vehicle.~   "
112182|NCT01587898|"~     This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group,~     multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in~     approximately 68 subjects with anemia associated with chronic kidney disease who are not~     taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility~     is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once~     daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.~   "
112183|NCT01587885|"~     This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination~     product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with~     frequent heartburn.~   "
112184|NCT01587872|"~     The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors~     can make the procedure difficult, and sometimes a complete examination is not possible.~     Complicating factors include poor bowel preparation and technical challenges such as~     differences in anatomy (long, redundant colonic segments), post-surgical adhesions,~     strictures and diverticulosis. A special endoscope with two inflatable balloons, originally~     designed to examine the small bowel, has been used for several years with success in such~     technically difficult colonoscopies. More recently a modified double-balloon instrument was~     designed specifically for colonoscopy, but the documentation of the performance of this~     instrument is limited. The aim of the present study is to investigate the performance of the~     double-balloon colonoscope in cases where conventional colonoscopy have failed due to~     technical difficulties.~   "
112185|NCT01587859|"~     Background:~      The existence, diagnosis and treatment of short esophagus is one of the controversies of the~     past which has recently re-emerged. The missed diagnosis of short esophagus and the~     consequent inadequacy of treatment is one of the major causes of failure of antireflux~     surgery.~      The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could~     take advantage of the definition of frequency, preoperative predictors, intraoperative~     management and post operative outcomes of cases of foreshortened esophagus, in order to~     offer the patient affected by GERD the elements necessary for a conscious choice of therapy~     and to plan the best performance of the surgical procedure.~      Aims of the Study To define the percentage of cases among the total of antireflux procedures~     performed for type II-IV hiatus hernia, in which, after standard isolation of the ge~     junction and dissection of the mediastinal esophagus at least two centimetres of esophagus~     can not be replaced without any applied tension below the apex of the diaphragmatic hiatus.~   "
112186|NCT01587846|"~     Beneficial therapeutic effect of probiotics has been reported in children with irritable~     bowel syndrome, but not consistently in other functional gastrointestinal disorders.~     Although there is evidence that probiotics increase stool frequency and decrease stool~     consistency in healthy individuals the evidence for efficacy in constipation is limited.~      Children with functional abdominal pain (FAP) and constipation will be included in the~     study. Children with FAP will be randomized in one of two groups and will receive either L.~     reuteri in a daily dose of 108 CFU, or placebo during three months. Children with chronic~     constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or~     placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and~     after intervention will be recorded in children with FAP. Frequency of defecation, stool~     consistency and need for lactulose will be recorded in children with chronic constipation.~   "
112187|NCT01587833|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      Benzodiazepines (BZDs) are one of the therapeutic groups most widely used, mainly indicated~     as hypnotics and anxiolytics. Guidelines recommend treatment courses not exceeding 4-6~     weeks. However, long-term treatment is highly prevalent, particularly in older people with a~     prevalence ranging from 15 to 30%. However, treatment is often taken as needed.~      Hip/femur fractures are a major cause of morbidity and mortality, impair quality of life and~     impose a considerable economic burden. Among people aged 50 years and older, a case-fatality~     rate of 20% is associated within the first year.~      The relationship between benzodiazepines and hip fractures remains controversial.~     Psychotropic medication has been traditionally associated with hip fractures. Among~     psychotropic medication, long elimination half-life benzodiazepines were found to increase~     the risk of hip fractures in a case-control study published in the late eighties. Since~     then, several investigations have been performed, mostly in older patients focusing on the~     relationship between benzodiazepines and hip fractures, and between benzodiazepines and~     falls as a mechanism underlying this effect. A review performed in 2003, which included 11~     epidemiological studies, reported that results were not always consistent. Seven out of~     eight cohort and population based case-control studies, found an association, but different~     results were reported according to benzodiazepines' half-life. In four hospital-based~     case-control studies no association between benzodiazepines use and hip fracture has been~     described. Data on dosing was only included in three of the studies, and once more results~     were not conclusive. Results ranged from no effect to an increased risk with high dose~     regimens. Results from subsequent succeeding studies have also shown contradictions, with no~     association reported in one of the studies, and an association described for the short-term~     use of short half-life, high-potency benzodiazepines.~      Even though there is epidemiological evidence suggesting that the use of benzodiazepines~     increases the risk of hip fractures, problems rise with the definition of benzodiazepine~     exposure, or biases such as confounding by indication and the control for confounders. These~     remain unresolved topics that should be addressed in future studies. In the present~     protocol, it is proposed to further asses the risk of hip/femur fractures associated with~     benzodiazepines using different study designs in different primary databases, and to compare~     the results in order to evaluate the impact of design and population differences on the~     outcome of the study association.~      The objective of this study is to assess the association between benzodiazepines use and~     hip/femur fracture with different study designs (descriptive, cohort, nested case-control,~     case crossover and self control case series) across different primary care databases~     (Bavarian, Mondriaan, National Databases (Denmark), General Practice Research Database~     (GPRD), Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria~     (BIFAP) and The Health Improvement Network (THIN)) and to compare the results between~     databases, across designs to evaluate the impact of design/database/population differences~     on the outcome of the studied association.~   "
112188|NCT01587820|"~     This is a randomized, open-label investigator initiated pilot/ feasibility study comparing~     the effectiveness of intra-arterial administration of cisplatin therapy to intravenous~     administration of cisplatin when each is combined with the radiation therapy found in~     standard care. Participants will be randomized to either intra-arterial or intravenous~     cisplatin chemotherapy. This study is designed to determine whether a large scale study is~     practical in the investigators clinical setting. Approximately 10 subjects will be enrolled~     over a 2 year period.~   "
112189|NCT01587807|"~     GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The~     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a~     single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a~     single-dose, parallel group design comprising 2 groups of healthy subjects assessing the~     effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose~     administered in Part 2 will be determined from emerging safety and PK data from Part 1 and~     Study TFR110951.~   "
112190|NCT01587794|"~     Experimental retinal detachment and reattachment models have demonstrated the recovery~     process of successfully reattached retina. However, optical coherence tomography analysis of~     each retinal layers following retinal reattachment has not been investigated This study~     investigated changes in thickness profiles of retinal layers after resolution of~     recent-onset rhegmatogenous retinal detachment (RRD) using optical coherence tomography~     images.~   "
112191|NCT01587781|"~     This study is about a drug called enoxaparin which is used to prevent or treat blood clots.~     There are no studies about the use of this drug in obese adolescents and yet the~     investigators use it to prevent clots when they have surgery at Children's National for~     weight loss. The investigators hypothesis is that the obesity leads to increased kidney size~     and faster drug clearance. Therefore the investigators think they might be underdosing these~     adolescents. This study will check the drug levels at different points after the drug dose~     to see whether the investigators are achieving the expected levels for prevention of clots.~   "
112192|NCT01587768|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test~     and disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on 5 key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation. The standards to develop will contribute to~     decreasing the discrepancies in results from different studies in the future and increase~     the usefulness and reliability of these studies for benefit-risk assessment in the EU.~      We propose to assess the association between antibiotics use and idiopathic acute liver~     injury with different study designs (descriptive, cohort, nested case-control and case~     crossover) across different primary care databases and to compare the results between~     databases, across designs to evaluate the impact of design/database/population differences~     on the outcome of the studied association.~      Specific aims (in each database):~        1. To describe characteristics, clinical features, and risk factors for acute liver injury~          in patients exposed and unexposed to antibiotics.~        2. To estimate the overall risk of acute liver injury associated with antibiotics exposure~          (users and non-users) in each database~        3. To estimate the risk of acute liver injury associated with various antibiotics classes~        4. To estimate the risk of acute liver injury associated with specific individual~          antibiotics~        5. To assess the effect of dose and duration of use for specific individual antibiotics.~        6. To compare the results of a case-control study with the results of a retrospective~          cohort study and self-controlled case series study in the different databases~      The proposed studies will be collected in populations from the following databases: The~     General Practice Research Database [GPRD] (UK), Health Improvement Network [THIN] (UK),~     BIFAP [Base de datos Informatizada para estudios Farmacoepidemiologicos en Atencion~     Primaria] (Spain)- the Bavarian Claims Database (Germany), Mondriaan (Netherlands), and the~     National Databases of Denmark.~   "
112193|NCT01587755|"~     A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together~     with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.~   "
112194|NCT01587742|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test~     and disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on 5 key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation. The standards to develop will contribute to~     decreasing the discrepancies in results from different studies in the future and increase~     the usefulness and reliability of these studies for benefit-risk assessment in the EU.~      Within WP2, five possible adverse event - drug pairs have been selected for analyses; one of~     these includes the possible role of calcium channel blockers (CCBs) in the risk of cancer.~     Analyses will address the hypothesis that CCBs modify the risk of cancer (all forms of~     cancer combined and various groups of cancers).~      This hypothesis will be investigated using two sources of data: the UK General Practice~     Research Database (GPRD) and the Danish national databases. Investigations in the UK may~     also use The Health Improvement Network (THIN).~      The primary objective of the study is to investigate the possible association between use of~     CCBs and risk of all forms of cancer combined, among adult patients (18 to 79 years of age~     during the study period, January 1, 1996 to December 31, 2009). The study will be conducted~     using three databases with different study designs (descriptive, cohort, population based~     cohort study and nested case-control) across different databases (GPRD, THIN, Danish~     databases) and to compare the results between databases, across designs to evaluate the~     impact of design/database/population differences on the outcome of the studied association.~      Secondary objectives are to investigate the potential association between use of CCBs and~     risk of all forms of breast cancer in women; all forms of prostate cancer; and all forms of~     colon cancer using the same age groups and databases).~   "
112195|NCT01587729|"~     The studies described in this protocol are all performed within the framework of PROTECT~     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)~     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and~     disseminate methodological standards for the design, conduct and analysis of~     Pharmacoepidemiological (PE) studies applicable to different safety issues and using~     different data sources. To achieve this, results from PE studies on five key adverse events~     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the~     methodological aspects of the studies in this protocol and not on the clinical consequences~     of the association under investigation.~      Fracture of the proximal end of the femur or hip is associated with considerable morbidity~     and mortality. Hip/femur fractures impair quality of life and impose a considerable economic~     burden, and occur with 20% mortality rate within the first year. Antidepressants (AD),~     mainly tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) have been~     associated with fractures in several studies. A review of 13 observational studies showed~     risk ratios ranging from 1.2 to 3.7 for current TCA users and a wide range of 1.5 to 8.6 for~     SSRI users. The majority of the studies in the aforementioned review reported increased~     risks of fractures in general with SSRIs use and more mixed risk outcomes for TCA use.~     Several mechanisms underlying this adverse effect have been postulated in the literature:~     e.g. through decrease in bone mineral density (BMD) or through blocking the serotonin~     transporter activity (5-hydroxytryptamine re-uptake) and hence affecting bone metabolism and~     structure or simply by falling or through co-morbidities such as depression itself. Previous~     observational studies differ in design, conduct and analysis of the considered association~     with varying degree of accounting for confounders. Confounding factors such as depression~     and other co-morbidities, previous fractures, concomitant drug use and lifestyle factors~     such as smoking have usually not been accounted for in most of the studies. In addition,~     small sample size, different methods used to ascertain exposure, selection bias and lack of~     data on compliance as well as important covariates limit the use of these results in~     benefit-risk analyses. Furthermore, studies evaluating different types of SSRI and TCA are~     few and dose-response relationship for most of the AD remains to be studied. We will study~     effects of cumulative exposure focusing on acute (less than 6 months) and long term exposure~     (at least 5 years) and doses of exposure.~      The objective of the study is to assess the association between AD use and hip/femur~     fracture using different study designs (descriptive, cohort, nested case-control and case~     crossover) across different databases and to compare the results between and across~     databases and designs. This is to evaluate the impact of design/database /population~     difference in the outcome of the studies association.~      Data will be collected from the following databases: The Health Improvement Network~     [(THIN]), a UK-based primary care electronic medical record database, the Dutch Mondriaan~     project (a primarily general physician based database with some linkage to survey data from~     the Netherlands), Base de Datos para la Investigación Farmacoepidemiológica en Atencion~     Primaria [(BIFAP] (Spanish primary care database)), and the Bavarian statutory health~     insurance physicians' association database (German health insurance database from primary~     and secondary care).~   "
112196|NCT01587716|"~     This is a study of the sodium channel inhibitor, GSK2339345. Cohort 1 will assess the~     safety, tolerability and PK of single ascending doses of GSK2339345 administered via an~     aqueous droplet inhaler in healthy subjects. Cohort 2 will assess the safety, tolerability,~     and PK of repeat doses of GSK2339345 administered four times a day for two consecutive days~     via an aqueous droplet inhaler.~   "
112197|NCT01587703|"~     This study is divided into two parts; Part 1 of the study is a dose escalation phase to~     select the recommended dose for Part 2 based on the safety, pharmacokinetic, and~     pharmacodynamic profiles observed after oral administration of GSK525762 in the following~     subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal~     cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple~     negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and~     MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability,~     pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part~     1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate~     cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER~     positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1~     and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in~     Part 1 to approximately 10-12 subjects in the United States to investigate the relative~     bioavailability of the besylate tablet compared to the amorphous free-base tablet at the~     maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat~     high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the~     dose proportionality of two doses of GSK525762 administered as besylate tablet.~   "
112198|NCT01587690|"~     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported~     in many human diseases. The purpose of this pilot study is to determine if microRNA~     expression is changed in untreated and interferon-beta-treated patients with multiple~     sclerosis.~   "
112236|NCT01587196|"~     The proposed project will use fMRI and specific probes of reward and inhibition as~     biomarkers predicting drug use during and after treatment in 72 subjects addicted to~     prescription opioids/medications. Subjects will be scanned before, during, and after 12~     weeks of active medication. The brain fMRI measures will be correlated with the primary~     clinical outcome of drug use (by urine drug screen) during the treatment and follow-up~     phase.~   "
114144|NCT01562132|"~     The purpose of this study is to determine if treatment with two medicines in combination~     (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for~     the treatment of an early infection with a fungus called cryptococcus.~   "
112199|NCT01587677|"~     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.~     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis~     require advanced and expensive diagnostic methods that restrict their availability in~     resource limited countries where the burden of tuberculosis is highest. The development of~     rapid point of care diagnostics is required.~      Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is~     released when bacteria are multiplying or dying. LAM can be detected in the urine since it~     is filtered from the blood in the kidneys. The detection of LAM in the urine by conventional~     enzyme linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low~     sensitivity and multiple processing steps. Recently, fluorescence linked immuno-sorbent~     assay (FLISA) has been shown to detect LAM in concentrations that are several magnitudes~     lower that with ELISA based methods. Furthermore the procedure requires less separate steps~     for processing the sample.~      This study aims to validate the new diagnostic test by comparing patients with (a) confirmed~     tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial~     carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated~     n=20). Single blood and urine samples of these groups will be used to evaluate the~     sensitivity and specificity of the test.~      In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker~     for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine~     are required during the first week, followed by twice weekly and weekly sampling intervals~     over a period of 12 weeks maximum. The study participation ends when the patient is~     discharged from hospital.~      As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent~     assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium~     tuberculosis.~   "
112200|NCT01587664|"~     The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez~     intra-laryngeal implant in patients with dysfunctional larynx.~   "
112201|NCT01587651|"~     This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized,~     3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study~     will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with~     ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have~     previously received ticagrelor loading does (LD) and maintenance dose (MD)..~   "
112202|NCT01587638|"~     This study used an observational, retrospective cohort design to compare the presence and~     timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with~     carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following~     cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate~     (referred to hereafter as 'other BB').~      The aim of the study was to investigate the likelihood of developing NOD among hypertensive~     patients initiating carvedilol therapy vs other BB therapy in a real world setting derived~     from data contained in a large United States (US) managed care database.~   "
112203|NCT01587625|"~     In a randomized control trial conducted in three hospitals in the southwest of Sweden,~     consenting nulliparous women in active phase of labour and with a defined delayed labour~     progress will be randomized to receive a regimen of either high or low dose of oxytocin.~     Primary outcome is caesarean delivery rate. Secondary outcomes are Apgar score < 7 at 5~     minutes, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous~     vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations,~     experienced labour pain, epidural analgesia and the women´s childbirth experience one month~     postpartum (assessed with Childbirth Experience Questionnaire). Study results will~     contribute to establish good evidence-based routines regarding oxytocin treatment of delayed~     labour progress.~   "
112204|NCT01587612|"~     Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited~     functional ability cause problems with work-related activities, sport activities and leisure~     activities.~      There are only few studies of the frequency of pain related to hyperpronation in foot and~     the effect of exercises. Medics and physiotherapists need sufficient evidence-based~     knowledge to treat these patients correctly.~      Therefore, the investigators want to study the effect of exercises and inner soles for~     treatment of patients with chronic pain and hyperpronation of foot.~   "
112205|NCT01587599|"~     Design and Procedure:~      The design is a randomised controlled multi-centre pilot study. 18 community pharmacies~     located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an~     intervention group. These pharmacies recruited eligible patients out of their clientele and~     invited them to take part in the study. Participants were visited at home by the pharmacist~     and home-based medication reviews were conducted. The survey form has been developed by the~     research team and comprised amongst others items to adherence, adverse effects, drug intake,~     storage and quality of life. Thereafter all data were analysed by the pharmacist with a~     newly developed document called analysis guide aiming at the detection of drug related~     problems. Pharmacists of the intervention group discussed the results with the family doctor~     of the patients and the patients and tried to solve the drug related problems. This~     procedure was not undertaken in the control group.~      Six months later a second medication review was carried out in both groups.~      Study hypothesis:~      Pharmaceutical care reduces the overall number of drug-related problems of elderly patients~     with diabetes and impairments in mobility.~      Aim:~      The purpose of this study is to show that pharmaceutical care reduces the overall number of~     drug-related problems of elderly diabetes-patients with impairments in mobility and leads to~     both an improved health status and an improved quality of life.~   "
112206|NCT01587586|"~     Primary objectives:~      The purpose of this study is to determine and compare the sustained virologic response (SVR,~     undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.~      To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment~     groups.~   "
112207|NCT01587573|"~     The purpose of this study is to verify the discriminatory value of previously identified~     salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use~     population of patients with oral lesions suspicious for cancer.~   "
112208|NCT01587560|"~     The purpose of the study is to investigate fixation to bone and the clinical results~     following shoulder resurfacing arthroplasty. The study will compare results between an~     implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.~   "
112209|NCT01587547|"~     The purpose of this study is to develop an algorithm for embryo selection based on amino~     acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on~     the ongoing implantation rate of the individual embryos transferred. As evaluated by~     ultrasound scan in gestational week 7.~   "
112210|NCT01587534|"~     The investigators planned a prospective, randomized, placebo controlled trial to test the~     hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion~     of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy~     in combination with dietary counseling.~   "
112211|NCT01587521|"~     Patients with schizophrenia are more likely to have metabolic syndrome compared to general~     population. The criterion for metabolic syndrome in Asian people including: elevated waist~     circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL~     cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg,~     elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with~     metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history~     of metabolic disorder, stress, and quality of life.~      However, little is known about the prevalence of and factors associated in Asian. This study~     aimed to:~        1. Identify the prevalence of metabolic syndrome in patients with schizophrenia.~        2. Identify the factors associated with metabolic syndrome in patients with schizophrenia.~   "
112212|NCT01587508|"~     The purpose of this study is to assess the efficacy end tolerability of a new drug~     containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components~     alone in the treatment of acute lumbago.~   "
112213|NCT01587495|"~     The investigators are doing this study to learn more about the dosing and safety of~     ertapenem in women with suspected serious infections less than 42 days from the delivery of~     their infant.~   "
112214|NCT01587482|"~     Nowadays, stenting is became a standard of care in revascularization for superficial femoral~     artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains~     in-stent restenosis (ISR). While most of local therapies have failed to demonstrate~     significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous~     transluminal angioplasty remains the current standard of care for this indication. Recent~     studies have shown successful results of drug eluting balloon in the treatment of SFA~     de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up~     to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of~     SFA atherosclerotic lesions.~   "
112215|NCT01587469|"~     This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a~     longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for~     pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium~     tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will~     be compared to gold standard conventional culture methods on two sputum specimens, in~     HIV-infected and HIV-uninfected participants.~   "
112216|NCT01587456|"~     The investigators planned to study relationship between osteoporosis and arterial rigidity~     within fractured patients cohort.~   "
112217|NCT01587443|"~     End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and~     social life, as well as overall quality of life (QoL). Health-related quality of life~     (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is~     affected by ESRD and/or its treatment, and has been increasingly used as an outcome measure~     in interventional studies. Additionally, associations between social support and QoL have~     been observed, indicating that improved social support could improve HRQoL, morbidity and~     mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal~     dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social~     support between HD and PD patients in the multiethnic society of Singapore have not been~     evaluated. As such, the investigators propose to conduct this cross-sectional study in the~     investigators local multiethnic ESRD patient population to evaluate and compare~     patient-reported outcomes (HRQoL and social support), economic and clinical laboratory~     outcomes in HD and PD patients.~      All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in~     this cross-sectional, observational study. Information on patient demographics,~     medical/medication histories, dialysis vintage, clinical laboratory data and associated~     medical costs will be obtained from clinic notes, electronic medical records and hospital~     databases. Patient-reported outcomes will be determined from scores of the Kidney Disease~     Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social~     Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological~     Distress Scale and Health Services Utilization questionnaires (for indirect costs), and~     compared between HD and PD patients.~      Results from this study will provide important HRQoL information to assist renal physicians~     and patients to make treatment decisions. Furthermore, intervention programs could be~     developed to improve social support based on patients' needs. These could in turn improve~     patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.~   "
112218|NCT01587430|"~     The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone~     consolidation followed by maintenance in the setting of high total cumulative anthracyclines~     dose(720-660 mg/m2).~   "
112219|NCT01587417|"~     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and~     pharmacodynamics of BI 187004 CL within a predefined dose range~   "
112220|NCT01587404|"~     Until recently, there was no way of telling how firmly the tip of the catheter was in~     contact with the heart and how this contact was orientated. The electrical signals measured~     through the catheters, known as electrograms, are used to guide the sites and duration of~     ablation, but the effect of catheter contact and orientation on these signals in human heart~     muscle that is fibrillating is not known. New catheters have now been developed which can~     measure the force of contact at their tip: using these, the investigators will examine how~     contact force affects the electrical behaviour of heart muscle tissue in atrial~     fibrillation. The effect the force of contact has on the electrogram recorded will also be~     investigated. In so doing we hope to gain a better understanding of the relationship between~     tissue contact and the electrograms we measure and in so doing improve the safety and~     effectiveness of ablation procedures.~      Hypothesis: Catheter contact force and orientation have a significant impact on the~     characteristics of bipolar electrograms in the fibrillating human atrium.~   "
112221|NCT01587391|"~     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and~     pharmacodynamics of BI 163538 XX within a predefined dose range~   "
112222|NCT01587378|"~     The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late~     miscarriages and preterm deliveries in PCOS women treated with metformin from first~     trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial~     setting.~      The investigators hypothesis is that metformin compared to placebo treatment from the first~     trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and~     preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003~     consensus criteria, with singleton pregnancy.~   "
112223|NCT01587365|"~     To obtain safety and tolerability information in healthy subjects is administered as a~     single dose~   "
112224|NCT01587352|"~     This phase II trial studies how well vorinostat works in treating patients with melanoma of~     the eye that has spread to other parts of the body. Vorinostat may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
112273|NCT01586715|"~     The purpose of this study is to evaluate the practicability of the autologous e-ASC~     (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant~     perianal fistulae.~   "
112225|NCT01587339|"~     There are a number of anti-epileptic drugs available for the treatment of partial onset~     seizures in patients with epilepsy. This study is a systematic review of the published~     literature on anti-epileptic drugs and is designed to compare the relative effectiveness and~     tolerability of a selection of them with retigabine. The drugs chosen for this comparison~     were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen~     because they belong to the newer generation of drugs for epilepsy (as does retigabine) and~     they have a similar license as well as having published data from studies that were~     conducted in similar patient populations with similar methods. GSK commissioned YHEC (York~     Health Economic Consortium) to carry out this review and analysis. YHEC identified relevant~     studies from international databases. These studies had compared one of the chosen~     anti-epileptic drugs with placebo. The results were pooled and combined in order to~     summarize the data for individual drugs as well to compare the results for different drugs~     with each other and with retigabine. Since none of the individual clinical studies compared~     one active drug with another, this systematic review is an indirect comparison of these~     drugs, using an established and recognised methodology which has well understood~     limitations.~   "
112226|NCT01587326|"~     The association of cytokines with escitalopram has not been investigated in patients with~     major depressive disorder (MDD). Hence, the investigators will examine this association.~   "
112227|NCT01587313|"~     This is a single center, open-label, two-period study. There will be nine healthy human~     volunteers arbitrarily assigned to one of four groups. The study objective is to compare the~     action of various combinations of BiDil extended-release capsules and commercial BiDil~     Tablets in the body over a period of time.~   "
112228|NCT01587300|"~     Medical scientists want to find better ways to treat neuroblastoma and to find ways to~     prevent the tumor from growing back. To do this, they need more information about the~     characteristics of neuroblastoma cells. Therefore, they want to study samples of~     neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that~     may be related to the growth of neuroblastoma cells. Doctors and other medical scientists~     also want to find better ways to detect and measure neuroblastoma to improve the ability to~     follow the response of tumor cells to therapy.~   "
112229|NCT01587287|"~     To comprehensively assess the precision and agreement of anterior corneal power measurements~     using 8 different devices.~   "
112230|NCT01587274|"~     Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7~     million visits annually. In a general low back pain (LBP) population, prognosis is poor.~     About 50% of patients who visited general practitioners with new onset musculoskeletal LBP~     report persistent pain and functional disability three months after the index visit.~     Outcomes are similarly poor for the population of patients forced to use an ED for~     management of their LBP. In an observational study of patients with non-traumatic LBP~     recently completed at the PI's institution, patients were contacted one week after ED~     discharge: 70% reported persistent back-pain related functional impairment, 59% reported~     moderate or severe LBP, and 69% reported analgesic use within the previous 24 hours. Three~     months after the ED visit, 48% reported functional impairment, 42% reported moderate or~     severe pain, and 46% reported analgesic use within the previous 24 hours.~      A variety of evidence-based medications are available to treat LBP. Non-steroidal~     anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain~     relief, global improvement, and requirement of analgesic medication. Skeletal~     muscle-relaxants too are effective for short-term pain relief and global efficacy. Opioids~     are commonly used for moderate or severe acute LBP,(9) though high-quality evidence~     supporting this practice is lacking.~      Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency~     physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination.~     Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle~     relaxants to monotherapy with just one of these agents. These trials have reported~     heterogeneous results. The combination of opioids + NSAIDS has not been evaluated~     experimentally in patients with acute LBP.~      Given the poor pain and functional outcomes that persist beyond an ED visit for~     musculoskeletal LBP, the investigators propose a clinical trial to evaluate whether~     combining muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy~     for the treatment of non-traumatic, non-radicular low back pain. Specifically, the~     investigators will evaluate three distinct hypotheses:~        1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than~          naproxen alone seven days after an ED visit, as measured by the Roland Morris low back~          pain functional disability scale~        2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of~          LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris~          low back pain functional disability scale~        3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of~          LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the~          Roland Morris low back pain functional disability scale~   "
112231|NCT01587261|"~     Animal and human data have supported the notion that administration of large doses of~     Vitamin C has beneficial effects on those subjects suffering from large burns. This effect~     may be due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C.~     These studies have demonstrated an improvement in urine output during resuscitation and~     reduced need for fluid volumes during resuscitation. In turn, these subjects demonstrated a~     reduction of wound edema, improved respiratory status (demonstrated by improvements in P:F~     ratios and reduced ventilator days), and no differences in terms of the possible~     complications of high-dose vitamin C administration between standard and treatment groups.~     The purpose of this study is to prospectively determine if Vitamin C can be safely used as~     an adjunctive treatment for patients suffering severe thermal injuries. High-dose vitamin C~     administered at a dose of 66mg/kg/hr during the acute phase of severe burn injuries will~     reduce fluid requirements in the first 48 hours after injury.~   "
112232|NCT01587248|"~     To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss~     (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site~     infection and postoperative pain in adult females undergoing MRM at a tertiary care~     hospital. We hypothesized that harmonic yields better outcome than electrocautery~     dissection.~   "
112233|NCT01587235|"~     This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current~     standard treatment with other statins for the treatment of dyslipidemia in moderate,~     moderately-high and high-risk participants.~   "
112234|NCT01587222|"~     The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin~     during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and~     followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks~     after the beginning of the treatment by isotopic evidence and biochemist determinations.~     Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma~     renin, aldosterone and norepinephrine).~   "
112235|NCT01587209|"~     The investigators hypothesize that membrane microparticles (MPs) are liberated into the~     blood stream in response to decompression stress and that certain MPs characteristics~     initiate inflammatory responses that contribute to the clinical syndrome the investigators~     call decompression sickness. The research goal is to evaluate the number, type and~     time-course for elevations in MPs in sport SCUBA divers who present for treatment of~     decompression sickness. Blood samples are to be taken from consenting patients before and~     after they undergo treatment for decompression sickness and at a follow-up clinic visit from~     1 to 3 weeks later (three samples total).~   "
112237|NCT01587183|"~     This study will test strategies to help people with prehypertension adopt a running program~     to reduce their blood pressure in the long term. This study will be a 12 week intervention~     of about 40 participants randomized to running educational material, group based running~     instruction, or group based running instruction focused on form and all given the option to~     use the supplemental mHealth intervention. The purpose of this study is to collect~     feasibility, acceptability and preliminary efficacy data in preparation for a larger planned~     NIH-R01 study.~   "
112238|NCT01587170|"~     After spinal cord injury, patients develop a spastic syndrome that is characterized by~     hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The~     neuronal mechanisms behind the development of spasticity remain largely unknown, though~     animal experiments have shown that changes occur both at the level of the motoneuron and~     sensory neurons. This project aims to examine the changes that occur in the modulation of~     sensory afferent transmission after spinal cord injury, and how these changes can contribute~     to the triggering and initiation of muscle spasms after chronic spinal cord injury in~     humans.~      It is known that after spinal cord injury, the majority of descending sources of monoamines,~     such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on~     sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a~     result, after spinal cord injury these receptors are no longer activated below an injury,~     resulting in the production of large, long excitatory responses in the motoneuron when~     sensory are activated. This large sensory activation of the motoneuron can, in turn,~     activate a long response in the motoneuron to produce an involuntary muscle spasm. The aim~     of our study is to determine whether, similar to animal experiments, the 5HT1 receptors are~     responsible for sensory inhibition in spinal cord injured subjects, and whether activating~     these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition~     of sensory transmission that is lost after injury, thereby resulting in a decrease in the~     initiation of involuntary muscle spasms.~   "
112239|NCT01587157|"~     Capnography provides noninvasive monitoring of ventilation and can allow early recognition~     of altered respiration patterns and apnea. The aim of this prospective study was to compare~     the detection of apnea and the prediction of oxygen desaturation and hypoxemia by~     capnography versus clinical surveillance during procedural sedation for percutaneous~     transhepatic cholangiodrainage (PTCD).~   "
112240|NCT01587144|"~     The purpose of the study is to determine the effectiveness of an investigational drug called~     lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of~     Glioblastoma Multiforme (GBM).~   "
112241|NCT01587131|"~     The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will~     be safe and generally well tolerated in healthy elderly adult volunteers and will result in~     greater immunogenicity when used to prime the immune response to a dose of a trivalent~     inactivated seasonal vaccine.~   "
112242|NCT01587118|"~     This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic~     Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of~     standard antidepressant treatment.~   "
112243|NCT01587105|"~     Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington~     State Department of Social and Health Services developed the Comprehensive Case Management~     (CCM) program with the goal to reduce costs of care for medically complex children cared for~     at SCH as well as improve their health status and the quality of care they receive. The CCM~     program aims to develop and facilitate a reliable and standardized process that empowers the~     child's primary care provider and provides him/her with the resources s/he needs to avoid~     unnecessary emergency department visits and admissions. Our study will include children who~     had a hospitalization or emergency department visit at Seattle Children's between 2009-2012~     and, at that time, had multiple active chronic medical issues but had no specialty service~     at Seattle Children's to help their primary care providers manage them.~   "
112244|NCT01587092|"~     This is a pilot study to assess the feasibility of using treadmill desks (Workstations)~     within a Louisiana office workplace and to determine the effects of walking while working in~     overweight or obese, sedentary individuals.~   "
112245|NCT01587079|"~     The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol~     Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate~     to severe COPD~   "
112246|NCT01587066|"~     Quetiapine is one of atypical antipsychotics with good efficacy and better side effect~     profiles than conventional antipsychotics, so it is being widely used beyond the treatment~     of schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is~     an effective and well-tolerated treatment for depressive episodes in bipolar disorder.~     However, most c1inicians did not have confidence with quetiapine monotherapy yet, and most~     practice guidelines recommend the monotherapy with mood stabilizer as the first-line~     treatment. The Korean medication algorithm for bipolar disorder published in 2006 also~     recommend the monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild~     to moderate depressive episode of bipolar disorder.~      Therefore, the aim of this study is investigating the efficacy and safety of quetiapine~     monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators~     are going to reveal the quality of sleep and quality of life, of the two groups of patients.~   "
112247|NCT01587053|"~     The purpose of this study is to measure the INR (International Normalized Ratio) time~     percentage in the target zone (TTR: time in therapeutic range) of children benefiting from~     the AVK therapeutic education program.~   "
112248|NCT01587040|"~     Primary Objective:~      The purpose of this study is to determine the long term safety and tolerability of SAR245408~     and SAR245409 as a monotherapy or as part of a combination regimen in subjects who are~     benefiting from treatment.~   "
112249|NCT01587027|"~     This safety study is the first in a series of studies testing the application of the~     combination of aminophylline and methazolamide.~   "
112274|NCT01586702|"~     Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial~     infarction. Poor adherence to evidence based secondary prevention regimens is frequently~     seen. Support programs for patients may not only improve adherence to recommended therapies~     but also reduce the recurrence rate of stroke and heart attack. The investigators~     hypothesize that compared to regular care, a structured and patient centered secondary~     prevention program will lead to a relative risk reduction of at least 28% of recurrent~     vascular events.~   "
112250|NCT01587014|"~     The purpose of this study is to test the safety and feasibility of the Prima-Temp~     Thermometer Patch in determining baseline temperatures of research subjects in a hospital~     intensive care unit (ICU).~      Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin~     site assessments.~      Secondary Objective: Establish individual subject baseline temperature using intermittent~     temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and~     wireless transmission of the data to a receiver box and HIPAA compliant, centrally located~     personal computer (PC) and compare research subject's baseline temperature with temperatures~     taken in the ICU in the normal course of care.~   "
112251|NCT01587001|"~     This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC),~     on inflammation and oxidative stress in sarcoidosis.~   "
112252|NCT01586988|"~     The IMAGE intervention was developed to improve parenting and self-care skills in mothers~     infected with HIV. It is expected that an improvement in these areas will in turn improve~     the mother's physical and mental health as well as the child's mental health and behavioral~     adjustment.~   "
112253|NCT01586975|"~     The purpose of this study is to determine if PFA results correlate with ischemic event~     outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more~     efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.~   "
112254|NCT01586962|"~     This is an open label, in-use study to assess the warming sensation, acceptability and local~     tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in~     subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to~     evaluate the acceptability concerning a warming sensation effect and its potential benefit~     in the target population.~      The primary objective is to assess the warming sensation caused by the excipient IFF flavor~     316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup.~     The syrup contains (0.15% w/v) warming flavor.~      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and~     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from~     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal~     congestion associated with colds and flu symptoms such as pain, headache and/or fever.~     Subjects must have one or more symptoms per category:~        1. mild to moderate body pain, headache, fever or sore throat~        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing~          Adolescents will be included in the study population~   "
112255|NCT01586949|"~     The purpose of this study is to determine whether the intervention Daily Challenge (MeYou~     Health, LLC), a behavioral intervention delivered online, is effective in improving~     individuals' well-being.~   "
112256|NCT01586936|"~     This study is conducted in Japan. The aim of this registry study is to observe the use of~     single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term~     outcomes, including effectiveness, safety, quality of life and treatment satisfaction with~     the approved treatments.~   "
112257|NCT01586923|"~     The hypothesis of this study is that prolonged-storage RBCs are not inferior to~     short-storage RBCs for the time required to clear elevated blood lactate levels in children~     with severe anemia.~   "
112258|NCT01586910|"~     The purpose of the study is to investigate the safety and efficacy of transcatheter aortic~     valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at~     intermediate surgical risk by randomizing patients to either Surgical Aortic Valve~     Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.~      Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of~     transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic~     Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the~     pivotal clinical trial.~   "
112259|NCT01586897|"~     This project tests a model of chronic disease medication management in which the decision to~     initiate or adjust medical therapy is directly linked to a sequence of subsequent clinical~     actions (e.g. monitoring for adverse drug events, assessing response to therapy, changing~     medication dose) performed independently of the office visit. The investigators hypothesize~     that establishing a visit-independent, health information technology (IT) supported cycle of~     laboratory monitoring and iterative medication dose adjustment will result in more effective~     chronic disease care.~   "
112260|NCT01586884|"~     It is hypothesized that it is both safe and feasible to use an interventional approach to LV~     lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the~     LV lead can be placed in a position that is superior to the initial empiric lateral wall LV~     lead location in less than 30 minutes without significant risk to patients. The time from RV~     capture to LV activation correlates with the optimal pacing site based on stroke volume &~     dP/dt measurements.~   "
112261|NCT01586871|"~     Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies,~     and they have been linked to heart health complications. However, there are currently no~     proven markers of heart and artery health for this population. The main purpose of this~     observational study is to evaluate the ease and convenience of a non-invasive measurement of~     artery function in MPS I, MPS II and MPS VI patients compared to healthy control subjects.~     An observational study is a research design meaning that there is no treatment in this~     study.~      The research questions are:~        1. Is the artery health of MPS I, II and VI patients different than healthy controls?~        2. Is the artery health of MPS VI patients different than MPS I and II patients?~      It is hypothesized that MPS patients will have poorer outcomes of artery health compared to~     healthy controls.~   "
112262|NCT01586858|"~     Rituximab is the first drug approved by the United States Food and Drug Administration (FDA)~     for the treatment of patients with granulomatosis with polyangiitis (Wegener's~     granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the~     long-term safety and efficacy of this drug is not yet clear. This study proposes to follow~     patients who were enrolled in the RAVE study to determine if treatment with rituximab~     influences long-term outcomes.~   "
112263|NCT01586845|"~     The purpose of this study is to demonstrate the efficacy and safety of voclosporin~     administered orally twice daily for the prevention of acute allograft rejection in~     recipients of a kidney transplant.~   "
112264|NCT01586832|"~     Stocking of essential supplies in an emergency department (ED) is crucial in order to~     efficiently and effectively take care of patients. When equipment and supplies are not~     available to patient care providers, an imbalance in the delivery of care is created. The~     amount of time nurses spend away from the bedside obtaining supplies has only been~     superficially studied; however, one study proposed that the majority of nurses spend 5 to 20~     percent or more of their time during a shift. This results in 30 minutes to two-and-a-half~     hours of a twelve hour shift being lost to retrieving supplies that are not available.~      Cabinets and drawers have recently been eliminated in the rooms and stock is kept in supply~     towers that contain all the necessary supplies to adequately take care of patients with the~     exception of medications, or stationary supplies. Towers are restocked every morning by a~     stocking technician by taking the towers to the stock room, resupplying them based on~     previously established PAR levels, and utilizing a standard chart that describes exactly~     what supply, and how many to stock within a specified area of the cart.~      During their shift, the stocking technician must also respond to pages concerning low stock~     levels.~      Hypothesis:~      Nurses spend a significant amount of time away from the patient bedside during their shift~     looking for supplies.~   "
112265|NCT01586819|"~     This study is being done to find out if the use of botulinum toxin prior to a medium~     strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid~     peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel~     alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block~     muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid~     (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two~     products/procedures have been FDA approved to improve the appearance of facial wrinkles.~   "
112266|NCT01586806|"~     For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative~     period can be a painful experience without adequate pain management. Hence the investigators~     propose a randomized controlled clinical study, investigating prolonged saphenous nerve~     blocks. Patients will be randomized to receive saphenous nerve blocks with or without~     dexamethasone, a corticosteroid used to prolong analgesia.~      Depending on the randomized treatment assignment, patients may receive one of the following:~        1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);~        2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;~        3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.~      Patients will be followed postoperatively. Following admission to the recovery room, data~     collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data~     collectors will also record patient satisfaction, pain medication use and any side effects~     experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative~     days 1, 2 and 14 and asked questions about their general well-being.~   "
112267|NCT01586793|"~     The aim of this randomized, single-blind trial is to evaluate the effectiveness and~     tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation~     (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive~     either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high)~     frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right~     dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several~     psychometric instruments at baseline, and at weeks 5 and 9.~   "
112268|NCT01586780|"~     The purpose of the study was to investigate the efficacy of intake of whey or soy protein~     isolates, respectively, with or without supplementation of amino acids, on post-meal insulin~     secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut~     hormones and ghrelin in plasma, as well as subjective satiety was investigated.~   "
112269|NCT01586767|"~     The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy~     (IMRT) or proton radiation therapy would result in improved local control rate and lowered~     toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result~     in equivalent or improved local control rate with similar or lower toxicity compared to~     IMRT, in the treatment of locally advanced sinonasal malignancy.~      Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in~     promising outcome in patients with sinonasal malignancy. To this date, no prospective study~     has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton~     radiation therapy. This Phase II trial is the first prospective study conducted to determine~     the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.~      IMRT and proton radiation therapy are the two most established and most commonly employed~     advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly~     controversial whether one is superior to the other in terms of local control and toxicity~     outcome. It is also not clear if a subset of patients would benefit more from one treatment~     technology versus the other.~      Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam~     is only available at a few centers in the United States, it is not feasible at present to do~     a Phase III study randomizing patients between IMRT and proton radiation therapy. In this~     study, a planned secondary analysis will be performed, comparing the treatment and toxicity~     outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial~     will be used to design future multi-center prospective trials and to determine if randomized~     trial is necessary.~      In this study, the treatment technique employed for an individual case will not be~     determined by the treating physician(s), but rather by the most advanced technology~     available at the treating institution for the treatment of the sinonasal cancer. At the~     Massachusetts General Hospital (MGH), proton beam therapy will be used for patients who meet~     the eligibility criteria. For institutions where protons are not available or institutions~     where the proton planning systems have not been optimized, IMRT exclusively will be used for~     the treatment of sinonasal cancer. Patient and tumor characteristics are expected to be~     comparable between IMRT- and proton- institutions~   "
112270|NCT01586754|"~     Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction~     and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic~     and randomized clinical trials. Carotis intima-media thickness is also found to be elevated~     in early stages of atherosclerosis. Recent studies have shown correlations between~     homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but~     no data exists for obese or overweight patients who also have metabolic syndrome, in terms~     of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular~     disease and since it is known that patients with metabolic syndrome are at higher risk of~     cardiovascular events, the investigators wanted to examine whether there is an association~     between homocysteine, microalbumin levels and carotid intima-media thickness in patients~     with or without metabolic syndrome, who are either overweight or obese.~   "
112271|NCT01586741|"~     This is a three armed prospective randomized trial that will compare two different surgical~     techniques for reconstruction of the abdominal wall diastasis with a conservative treatment~     procedure.~      The study hypothesis:~      Which surgical approach provides the safest and best long term results for patients with~     abdominal wall diastasis either the insertion of net alternative with a double row suture or~     exercise alone?~   "
112272|NCT01586728|"~     This is an open, multicenter, prospective, randomised and cross over study, comparing in~     patients with cystic fibrosis aged > 6 years, 2 periods of 6 weeks of oxygen therapy or room~     air, separated by a wash out period of 2 to 6 weeks.~   "
112275|NCT01586689|"~     This study is examining the relative effects of alternative aftercare models for~     ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal,~     randomized field trial that assigns participants to one of three conditions: Oxford House, a~     professionally-run residential treatment facility, or a control condition that involves~     usual aftercare chosen by participants (which may include no treatment at all). Oxford~     Houses are self-run residential recovery homes based on the premise of mutual support. These~     homes do not involve professional treatment staff and the expenses (e.g. rent, utilities)~     are paid for by the residents. The hypothesis of this study is that Oxford House~     participants will have as good or better outcomes in terms of substance recovery,~     recidivism, and health in comparison to the participants who were assigned to the~     residential treatment facility, and better outcomes in comparison to the control group. In~     addition, the cost to government/tax payers will be substantially lower given that~     participants pay their own way.~   "
112276|NCT01586676|"~     The virtual requirement that substance abuse programs use evidence-based treatments (EBT)~     has prompted the development of dissemination strategies to promote EBT technology transfer.~     Implementation research, clinical trial training methods, and clinician training studies~     suggest that clinical supervision that involves direct observation, fidelity rating-based~     feedback, and coaching of therapeutic skills is a promising dissemination approach. However,~     clinical supervision delivered within substance abuse programs by on-site supervisors has~     never been directly tested in a randomized controlled trial to determine the impact of~     supervision on both clinician EBT skills and client treatment outcomes.~      Recent results from two NIDA CTN protocols testing the effectiveness of Motivational~     Interviewing (MI) have shown that community program clinicians can learn to deliver MI with~     fidelity when receiving MI supervision from their program supervisors after workshop~     training and that their implementation of MI early in treatment improves client retention~     and primary substance use outcomes. A MI supervision manual called MIA: STEP (Motivational~     Interviewing Assessment: Supervisory Tools for Enhancing Proficiency) was developed from~     these protocols and has begun to be widely distributed by NIDA in partnership with SAMHSA~     for community program use. The effectiveness of the MIA: STEP supervision approach is~     unknown.~      This study will directly test the effectiveness of MIA: STEP supervision on clinician MI~     fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using~     outpatients from 11 community programs within Connecticut to one of two conditions in which~     clinicians in both conditions will deliver a 1-session MI intervention to clients as the~     enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2)~     workshop training alone with supervision-as-usual practices used at each program. This~     project will be the first randomized trial to examine the impact of clinical supervision in~     an empirically based treatment on both clinician and client outcomes. Moreover, because it~     will provide workshop training and supervision completely within the context of community~     programs and utilize in-house program supervisors, it will provide a rigorous evaluation of~     a feasible model for disseminating EBTs such as MI.~   "
112277|NCT01586663|"~     This is a randomized controlled trial with blinded evaluator and follow-up of one year.~     Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The~     patients can not change their medication during the study. Patients will be evaluated at~     baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time~     position splint who will be adjusted monthly, while the control group will remain the drug~     treatment. The outcomes assessed will be: pain, hand range of motion, quality of life,~     functional capacity, upper limb function and dexterity. Our hypothesis is that the serial~     night time position splint will improve the hand range of motion in diffuse systemic~     sclerosis patients.~   "
112278|NCT01586650|"~     This is a randomized controlled trial with blinded assessor on the effects of aerobic~     exercise (walking)in patients with Ankylosing Spondylitis.~   "
112279|NCT01586637|"~     Effectiveness of an art therapy program for the treatment of pain and improvements in both~     quality of life and body image of patients with fibromyalgia.~   "
112280|NCT01586624|"~     The purpose of this study is to determine whether using two drugs together called vandetanib~     and selumetinib is effective in the treatment of cancer. The first part of this study will~     include patients with any solid tumour and the second part of this study will include only~     patients with non small cell lung cancer. The four main aims of this clinical study are to~     find out:~        -  If the two drugs can be given safely to patients when given together.~        -  The maximum dose that can be given safely to patients.~        -  More about the potential side effects of the drugs and how they can be managed.~        -  What happens to vandetanib and selumetinib inside the body.~   "
112281|NCT01586611|"~     Chemotherapy is often used to help shrink the cancer temporarily and may improve survival~     for patients with incurable pancreas cancer that has spread to other organs. In Canada, the~     gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination~     of oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and~     irinotecan has also been studied and has benefit for patients with advanced pancreas cancer.~     To date, there is no test that can be done on a patient's tumour to tell if chemotherapy~     will work in pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has~     been shown to be a possible predictor that gemcitabine may or may not work but this needs to~     be proven in a randomized study where patients get treated with gemcitabine or a different~     kind of chemotherapy while their tumours get tested for hENT1.~      This study is being done because we want to prove that hENT1 can predict if gemcitabine will~     work in advanced pancreas cancer and if it can, we also would like to show that a different~     chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and~     oxaliplatin) will be helpful for patients whose tumours don't have hENT1.~   "
112282|NCT01586598|"~     The purpose of this study is to determine whether sensory retraining exercise could improve~     lip numbness caused by bilateral sagittal split of mandible.~   "
112283|NCT01586585|"~     The investigators will monitor cardiac patients rehabilitation post op upon their pre op~     status.~   "
112284|NCT01586572|"~     Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases~     continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in~     tribal areas present special challenges in interrupting transmission rapidly. There exists~     limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity~     levels in young children. The aim of this study is to demonstrate the non-inferiority of~     shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary~     interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals~     beginning at 6 weeks of age.~   "
112285|NCT01586559|"~     A comparative prospective study assessing the outcomes of recti muscle diastasis correction~     with absorbable suture.~   "
112309|NCT01586247|"~     Healthy older volunteers will be recruited to a study where they will be given four~     different treatments over a 28 week period. These treatments include: a prebiotic, a~     probiotic, a synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and~     saliva will be collected and analysed for changes in faecal microbial populations and~     selected immune responses.~   "
112286|NCT01586546|"~     Aim: To answer the questions of whether a Mind-Body Medicine (MBM) skills group facilitated~     face-to-face and online can improve measures of Quality of Life (QOL) in a population of~     cancer patients.~      Value of Study: Technological advances have contributed to new venues for healthcare~     delivery. It is imperative that these new delivery methods, for individual and/or group~     psychosocial services are sufficiently tested and validated. Research shows that there is~     very little knowledge about differences in communication styles between online and~     face-to-face groups, nor is there much knowledge on the overall efficacy of online groups.~      Phenomenon Studied: Can MBM skills groups improve the quality of life of cancer patients? Is~     there a difference in outcome between a MBM skills group delivered face-to-face and a MBM~     skills group delivered online.~      Reasons Leading to Proposing the Project: Despite encouraging research showing that~     psychosocial interventions have positive effects in the lives of cancer patients, more~     research is needed due to several problems of current research, such as poor study design,~     lack of use of technological advances and relatively few existing studies on the~     effectiveness of MBM therapies in the oncological setting.~      Stated Hypothesis:~      Hypothesis 1:~      There is no difference between baseline QOL measures and QOL measures at the end of~     face-to-face facilitated MBM skills groups.~      Hypothesis 2:~      There is no difference between baseline QOL measures and QOL measures at the end of Online~     facilitated MBM skills groups.~      Hypothesis 3:~      Participation in either, online facilitated MBM skills groups or face-to-face facilitated~     MBM skills groups will improve QOL measures when compared to control group.~      Hypothesis 4:~      Patients in the control group (waitlist control, care as usual group) will have no~     improvement on QOL measures.~      Anticipated Value to the Larger Community: According to the National Center for~     Complementary and Alternative Medicine (NCCAM) …there is a need for reliable, objective,~     evidence-based information regarding the usefulness and safety—or lack thereof—of CAM~     (National Center for Complementary and Alternative Medicine, 2011, p.3). This study will add~     to general scientific knowledge of CAM and MBM.~   "
112287|NCT01586533|"~     This double-blind, randomized, comparator-controlled Phase II study is designed to establish~     the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with~     left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease~     activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects~     will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or~     comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally~     into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the~     trial will be enrolled concurrently in a randomized fashion.~   "
112288|NCT01586520|"~     Thyroid cancer is a relatively rare disease but its incidence is increasing in many~     countries.. Early and accurate diagnosis leading to earlier treatment and intervention is~     recognised as a major factor in determining a good outcomes. This study will investigate new~     ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers.~     The study will take samples from patients with differentiated thyroid cancer and measure~     relative quantities of 1000s of proteins within the blood. These measures will be explored~     to see if, when used in combination they can accurately diagnose thyroid cancer. If~     successful this technique could be extended to routine screening and could replace more~     invasive tests currently used. Participants will be required to supply a small sample of~     blood, answer questions on their medical history and also consent for their medical records~     to be examined. A lifestyle questionnaire will also be supplied to each participant. In the~     case where a diagnosis is predicted for a condition the participant was not aware of the~     medical team will discuss the best interests of the patient with their GP and if required~     refer them to a suitable specialist. The study will run for 24 months and will routinely~     process around 15 and 20 participants with a history of thyroid cancer per month. All~     patient details will be kept confidential and only non identifiable information will leave~     the clinic. The work will be published and if successful will be validated on another site,~     commercialised and made available for routine clinical use.~   "
112289|NCT01586507|"~     The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of~     ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old,~     inclusive (up to 17 years 364 days) with pain due to injury or nonmalignant disease, to the~     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic~     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and~     how it is removed from the body over time.~   "
112290|NCT01586494|"~     The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of~     ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old,~     inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the~     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic~     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and~     how it is removed from the body over time.~   "
112291|NCT01586481|"~     It's a pilot prospective opened multicentric randomised study. We measure the efficiency and~     the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK)~     to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic~     patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis~     or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with~     BAROUK shoe~   "
112292|NCT01586468|"~     Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects~     with persistent allergic rhinitis.~      Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre~     trial.~      Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis~     for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be~     required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)~     (mean score of morning and evening reflective TNSS assessments for the 3 days prior to~     randomization and treatment.~      Treatments At the first treatment visit (T1), subjects that comply with the inclusion and~     exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.~      Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into~     500 mL saline solution. Treatment will be administered once daily for 5 consecutive days~     (Visits T1-T5) via intravenous infusion.~   "
112293|NCT01586455|"~     The purpose of this clinical trial is to investigate the safety of human placental-derived~     stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in~     patients with various malignant or nonmalignant disorders who require a stem cell~     transplant. Patients will get either full dose (high-intensity) or lower dose (low~     intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and~     HPDSC.~   "
112294|NCT01586442|"~     In this proposal,the investigators will examine whether the selectivity of eplerenone for~     the MR will translate into a better glucose and metabolic profile compare to spironolactone~     in patients with HF with glucose intolerance or type 2 diabetes. In addition, the~     investigators will also compare the impact of these two agents on changes of concentrations~     of established prognostic biomarkers of neurohormonal activation and extracellular matrix~     turnover.~   "
112295|NCT01586429|"~     Post-operative pain following total knee replacement can be disabling and sometimes lead to~     the need for prolonged hospital stay. Therefore development of improved post-operative~     modalities for total knee replacement surgery pain control is important. High-resolution~     ultrasound (US) allows accurate visualization of nerves and surrounding structures and can~     lead to higher success rates of nerve block. The investigators aim at comparing the~     analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural~     analgesia for patients with knee OA who underwent unilateral total knee replacement.~   "
112296|NCT01586416|"~     The purpose of this study is to develop and pilot test a behavioral intervention for elderly~     adults in treatment for colon cancer, to enhance their skills for managing the challenges of~     completing chemotherapy regimens. The investigators will assess feasibility and~     acceptability of the intervention, and explore preliminary efficacy of the intervention for~     reducing psychological distress and improving rates of optimal chemotherapy adherence.~   "
112297|NCT01586403|"~     This is a phase one trial to determine if genetically engineered lymphocytes can be safely~     delivered to patients with metastatic melanoma.~   "
112298|NCT01586390|"~     In this study we compare two treatment options for ankle sprains. 100 patients were~     randomised between a flexible cast treatment and a removable and adjustable brace made out~     of the same materials.~      Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures~     were patient satisfaction scores with treatment as well as treatment result.~   "
112299|NCT01586377|"~     Recent clinical investigations have suggested that the cause of abnormal pain in complex~     regional pain syndrome could be ischemia and inflammation, due to poor blood flow to deep~     tissues from microvascular pathology. This study aims to determine if a new technology~     called near infrared spectroscopy can measure this microvascular dysfunction. The study~     hypothesizes that significant differences can be measured in the microcirculation of~     patients with CRPS-I using near infrared spectroscopy and the vascular occlusion test.~   "
112300|NCT01586364|"~     The objective of the study was to assess the long-term safety of daily doses of ospemifene~     60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a~     uterus.~   "
112301|NCT01586351|"~     The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix~     from Arthrex is possible with the arthroscopic technique.~   "
112302|NCT01586338|"~     Primary Objective:~        -  To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis~          Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score~        -  To evaluate the safety using the incidence, severity, seriousness, relatedness, and~          frequency of all treatment emergent Adverse Events (AEs)~      Secondary Objectives:~        -  To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks~          8, and 12~        -  To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and~          26~        -  To evaluate the change in Patient Global Assessment (PTGA) score between baseline and~          weeks 8, 12 and 26~        -  To evaluate the change in Clinical Observer Global Assessment (COGA) score between~          baseline and weeks 8, 12 and 26~        -  To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and~          between baseline and weeks 1, 2, 8, 12 and 26~   "
112303|NCT01586325|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a~     drug is absorbed and distributed in the body), and intrinsic antiviral activity of~     JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus~     (HCV)-genotype-1-infected patients at different doses and dose regimens.~   "
112304|NCT01586312|"~     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells~     (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis.~     The trial is based in our own previous results with autologous MSC (ongoing NCT01183728~     trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized,~     blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The~     assay consists of two arms with 15 patients each one. Patients in the experimental arm will~     be given an intra-articular transplantation of allogenic MSC, expanded Ex Vivo with our~     GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as~     in NCT01183728). In the control arm a standard treatment with intra-articular injection of~     hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality~     of life and quantitative changes in structure and composition of cartilage determined by~     T2-weighted MRI relaxation (Cartigram) for one year.~   "
112305|NCT01586299|"~     The purpose of this study is to evaluate the influence of routine NSAIDs treatment for~     hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all~     in conjunction with adequate antibiotic therapy).~   "
112306|NCT01586286|"~     The objective of this study is to perform a randomized controlled trial among female~     patients with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with~     associated pain, dysfunctional voiding, dyspareunia, and/ or obstructed defecation.~   "
112307|NCT01586273|"~     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic~     Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating~     painful bone metastases.~   "
112308|NCT01586260|"~     The purpose of this research study is to evaluate a new investigational drug to prevent~     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The~     objectives of this study will be to monitor for safety and look at efficacy of DFMO.~      The safety of the proposed dosing regimen in this trial will be tested by an on-going~     risk/benefit assessment during the study. A patient benefiting from treatment, not~     progressing on therapy, and in the absence of any safety issues associated with DFMO may~     continue on treatment up to 27 cycles with the expectation that there will be an overall~     clinical benefit.~      The procedures involved in this study include Medical history, Physical exam, Vital signs~     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the~     tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are~     considered standard of care for this population. Drug administration is also part of this~     protocol, including an investigational new drug called DFMO.~      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day~     while on study. There will be 27 cycles. Each cycle will be 28 days in length.~   "
112314|NCT01586182|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational intervention (in this case, the stereotactic radiation boost). Phase I~     studies also try to define the appropriate dose of the investigational intervention to use~     for further studies. Investigational means that the stereotactic radiation treatment is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved a stereotactic radiation boost for your type of cancer.~      In this research study, the investigators are looking for the highest dose of the~     stereotactic radiation boost that can be given safely. Because the stereotactic radiation~     boost is so precise, the investigators are testing whether it can be used to increase the~     dose to the primary tumor without significantly increasing the side effects you experience;~     the goal is to improve the likelihood of successfully treating the tumor.~   "
112315|NCT01586169|"~     The purpose of this study is to determine whether the triple co administration of~     albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that~     consists to treat with albendazole plus ivermectin together and a week later to treat with~     azithromycin in areas co endemic for lymphatic filariasis and trachoma.~   "
112316|NCT01586156|"~     Pulmonary arterial hypertension (PAH) is a serious condition characterized by endothelial~     dysfunction leading to pulmonary vascular constriction, smooth muscle and endothelial~     proliferation, and progressive right-sided heart failure. The severity of pulmonary~     hypertension is mostly determined by the response of the right ventricle (RV) to the~     increased afterload or pulmonary pressures, and RV failure is the leading cause of death in~     PAH. Most accepted therapies for PAH have been aimed at vasodilation of the pulmonary~     vasculature, and there has been little thought that PAH patients would benefit from~     traditional left heart failure treatments. A cornerstone therapy in left heart failure is~     £]-adrenergic receptor blockade because of its ability to reverse cardiac remodeling and~     improve clinical outcomes, despite decades of concern regarding its propensity to exacerbate~     heart failure. It has been reported to reduce mortality by about 30% in patients, and while~     the precise mechanisms that contribute to its beneficial effects remain to be elucidated,~     there is evidence that patients with underlying contractile reserve (i.e., via recruitment~     of viable myocardium with £]-adrenergic receptor stimulation) may experience greater~     recovery of their cardiac function. In a study using rats with pulmonary hypertension~     treated with £] blocker, RV function improved, and maladaptive myocardial remodeling was~     prevented.~   "
112317|NCT01586143|"~     This is a clinical study that aims to investigate and compare the efficacy of transbuccal~     paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with~     acute pain of moderate intensity accepted to emergency room following a minor trauma of the~     lower limbs and/or superiors. To this end, several pain scoring will be performed using a~     visual analogue scale (VAS) at various times after drug administration.~   "
112318|NCT01586130|"~     Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs,~     especially the quadriceps; leading to disease progression. Advantages of muscular strength~     training for the treatment of this kind of O.A. is now well established. In this therapeutic~     field, isokinetic exercises seem to have a better efficiency than other, more frequently~     used, kinds of exercises such as isometric or isotonic exercises.~      Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces~     muscles to work in eccentric mode.~      The hypothesis of this study is that muscular strengthening using isokinetic exercises in~     eccentric mode would have a more important benefit than isokinetic exercises in concentric~     mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative~     knee exercises in the treatment of knee O.A.~   "
112319|NCT01586117|"~     The purpose of this study is to evaluate the effect of intrarectal Amifostine administration~     on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.~   "
112320|NCT01586104|"~     This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating~     younger patients with lung metastases. Specialized radiation therapy that delivers a high~     dose of radiation directly to the tumor may kill more tumor cells and cause less damage to~     normal tissue.~   "
112321|NCT01586091|"~     Primary objective:~      The comparative efficacy of levocetirizine 5 mg once daily with that of fexofenadine 60 mg~     twice daily against histamine induced wheal, flare and itch responses measured at 0~     (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours.~      Secondary objectives:~        1. The areas under the curves (0 , 12 hours, 12 - 24 hours and 0 - 24 hours) for~          inhibition of histamine induced wheal, flare and itch responses for levocetirizine 5 mg~          once daily and fexofenadine 60 mg twice daily.~        2. The number of individuals with peak responses in each 10 percentile (Because of the~          variable absorption of fexofenadine, it is predicted that fexofenadine will have a~          variable response between individuals).~        3. The mean plasma levels of levocetirizine and fexofenadine at 0 (baseline), 0.5, 1, 2,~          3, 4, 6, 8, 10, 12 and 24 hours.~   "
112322|NCT01586065|"~     The purpose of this study is to see if children and adolescents with poorly controlled type~     1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be~     used to check blood sugars.~   "
112323|NCT01586052|"~     This purpose of this phase 1 study is to investigate the safety and efficacy of~     erythropoetin for children with cerebral palsy.~   "
112347|NCT01585740|"~     The objective of this study is to compare the effect on mean maternal and neonatal pH, and~     24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated~     versus normal saline in caesarean section at Mulago Hospital.~      The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section~     at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than~     intraoperative infusion of normal saline.~   "
112564|NCT01582828|"~     Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the~     surgical (epicardial) approach seems to be the most effective. Still, however a significant~     amount of failures exist which is mostly due to incompleteness of the surgical ablation~     lines. Checking, and if necessary additional ablation, of these lines afterwards~     endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this~     problem.~   "
112565|NCT01582815|"~     The purpose of this study is to evaluate the efficacy and overall safety and tolerability of~     treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety~     symptoms being treated with an antidepressant.~   "
112324|NCT01586039|"~     The timing and quality of sleep is governed by environmental and physiologic factors.~     Environmental factors, especially ambient lighting can impact the circadian system and alter~     the timing and structure of sleep. Light exposure can also acutely alter neural activation~     state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength~     blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue~     light in the evening persist for at least 3-4 hours after the lights are turned off, and can~     disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to~     sleep on subsequent sleep would be beneficial to sleep quality and potentially health.~      The investigators will compare the effects of two light sources, equated for visual stimulus~     (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux~     exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white~     light source that is depleted in the short-wavelength visible range (Biological Illumination~     LCC, FL). In a within-subject design, the investigators will test the hypotheses that~     exposure as compared to a CFL 90 lux exposure 90 lux of the blue-depleted LED will cause~     significantly:~        1. Less melatonin suppression between melatonin onset and bedtime;~        2. Less subjective and objective alerting responses before bedtime;~        3. Less disruption of nocturnal sleep structure and quality.~   "
112325|NCT01586026|"~     This study is to compare the rate of adverse events in subjects with maintenance flushes~     greater than 28 days.~   "
112326|NCT01586013|"~     This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol~     model. The plasma effect-site rate constant (ke0) obtained is affected by age.~   "
112327|NCT01586000|"~     This clinical trial is an experimental research study using a potential new form of birth~     control. Clinical trials include people who volunteer to take part in a study. Take your~     time to decide if you want to be part of this experimental research study. If you want to~     know more about this study first, ask the study doctor or study site staff. The~     investigators can also give you the study information written for doctors and clinic staff.~   "
112328|NCT01585987|"~     The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as~     sequential or maintenance treatment immediately after first-line chemotherapy in the~     treatment of unresectable or metastatic gastric and gastro-esophageal cancer.~   "
112329|NCT01585974|"~     This study is a prospective, non-interventional, non-controlled, multi-center, observational~     cohort study. The medication is prescribed within the regular practice of the physician.~     Duration and dosage of treatment is solely at the discretion of the attending physician. The~     primary objective of this study is to assess duration of treatment in Turkish renal cell~     carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate~     prior cytokine treatment within the first month of treatment.~   "
112330|NCT01585961|"~     This is a prospective, interventional, observational, unblinded, single-arm, multicenter~     registry of younger and older subjects with drug refractory, recurrent, symptomatic~     paroxysmal atrial fibrillation.~   "
112331|NCT01585948|"~     In the present study the investigators will measure the extent of coronary artery disease~     via coronary angiography and the correlating risk factors.~   "
112332|NCT01585935|"~     Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot~     immediately be nourished with mother´s or formula milk and are typically dependent on~     parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver~     complications of PN, namely parenteral nutrition associated cholestasis (PNAC).~      Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision~     of energy and essential fatty acids in preterm infants. However, they might be implicated in~     the pathogenesis of PNAC.~      ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion~     containing 15 % fish oil together with soy bean, olive and MCT oil has become available in~     Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the~     standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore~     ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there~     are no data so far.~      The study aims to evaluate the fish oil containing ILE SMOFlipid® for its protective~     effect against PNAC in ELBW infants compared to standard treatment with the soy bean based~     ILE Intralipid®. Furthermore neurodevelopment at 12 and 24 months of corrected gestational~     age will be investigated.~   "
112333|NCT01585922|"~     In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on~     decreasing inflammatory response, improving the pathophysiological manifestation and~     reducing the morbidity and mortality in the moderate acute respiratory distress syndrome~     (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive~     mechanical ventilation in more than twenty ICUs in China.~   "
112334|NCT01585909|"~     The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in~     preventing invasion of gastrointestinal bacteria.~   "
112335|NCT01585896|"~     The proposed study aims to investigate the efficacy of a facilitated self-help group for the~     treatment of hoarding disorder. Eligible participants will take part in a facilitated~     self-help group. The investigators aim to investigate the effects of a self-help group on~     hoarding symptoms. The investigators hypothesize that participants will demonstrate~     decreased hoarding symptoms over time.~   "
112336|NCT01585883|"~     The purpose of this study is to investigate the suitability and practicality of a coaching~     and support intervention in helping patients to use daily strategies for managing~     breathlessness. Also, the investigators will try to understand how useful it is in helping~     patients to reduce intensity of breathlessness and its impact their quality of life.~   "
112363|NCT01585519|"~     This study will examine if health benefits of consuming nutrient-rich apples, an apple~     extract and freeze dried apple product will be similar. 50 volunteers at increased risk of~     heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol~     apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten~     participants per group, randomly assigned). Apart from the extract group, all volunteers~     will consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other~     than what has been provided by the research team. Volunteers will complete food diaries at~     the start and end of the study and a number of questionnaires. Blood and urine samples~     collected at 0 and 4 weeks~   "
112337|NCT01585870|"~     This Phase 1 study will be conducted in an open-label, non-randomized, dose-escalation~     design in subjects with advanced, metastatic or refractory solid malignancy who are not~     candidates for standard therapy. The study drugs are sorafenib and eribulin mesylate.~      Up to 24 subjects with solid tumors will participate in the dose escalation part of the~     study, and once the maximum tolerated dose is defined, up to 30 subjects with advanced,~     metastatic or refractory solid tumors will participate in the expansion phase of the study.~      Eribulin (mesylate) will be administered intravenously at a fixed dose of 1.4 mg/m2 on Days~     1 and 8 of 21-day Cycles.~      The starting sorafenib dose (Dose Level 1) is 200 mg twice daily. Sorafenib is given orally,~     continuously on days 11 to 21 of Cycle 1, and from Day 1 to Day 21 of all subsequent cycles.~     If 200 mg sorafenib twice daily is tolerated with eribulin, the sorafenib dose will be~     escalated sequentially to 200 mg morning dose and 400 mg evening dose (Dose Level 2) in a~     new cohort. If Dose Level 2 is tolerated, a second dose escalation to 400 mg twice daily~     (Dose Level 3) will be studied in a new cohort. If the starting dose of sorafenib is not~     tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg once daily in a~     new cohort. Subjects will need to receive two cycles of eribulin plus sorafenib therapy and~     safety data for the first and second cycle needs to be available before the start of the~     next cohort.~   "
112338|NCT01585857|"~     Primary:~      To study the safety of a single injection of autologous adipose derived mesenchymal stromal~     cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).~      Secondary:~      To study the efficacy of a single injection of autologous adipose derived mesenchymal~     stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).~   "
112339|NCT01585844|"~     Obstructive sleep apnea is known to be a significant source of morbidity in the general~     population. It has been proposed to be associated with the development of preeclampsia and~     fetal growth restriction. As these are conditions that have long term maternal and neonatal~     implications, further information may help improve maternal/fetal outcome. One reason why~     women and in particular pregnant women are under diagnosed is the lack of an effective,~     reliable screening tool. Validated questionnaires used in the general population may not be~     effective in screening pregnant women. The investigators hypothesize that sleep apnea will~     have 20% prevalence in the obese pregnant population and that it is associated with~     increased maternal and neonatal morbidity. The investigators will recruit obese pregnant~     women in their prenatal care clinics and they will be screened for OSA using validated sleep~     questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin~     Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a~     portable sleep apnea detection device. Women who meet clinical criteria for OSA will be~     referred for overnight polysomnogram and management by the Pulmonary and Critical Care~     Division of the Internal Medicine Department. For all enrolled patients the remainder of~     prenatal care will be per routine. Data will be collected regarding the pregnancy course and~     outcomes.~      The primary outcome of interest is the prevalence of sleep apnea in obese women and the~     associated maternal and neonatal morbidity. The secondary outcome measures will be molecular~     measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep~     apnea.~   "
112340|NCT01585831|"~     The purpose of this study is to determine if testosterone replacement therapy leads to~     changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also~     called Klinefelter syndrome). This study will also evaluate whether certain genetic factors~     of the X chromosome affect the psychological or motor features of XXY/Klinefelter syndrome.~   "
112341|NCT01585818|"~     Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally~     accepted as the cornerstone for the treatment of people with type 2 diabetes mellitus~     (T2DM). Consumption of low glycaemic index (GI) meals have been shown to improve glycaemic~     control, lipid profile and reduced systemic inflammation. However, these studies and~     international evidence-based nutritional recommendations are principally based on people of~     European ethnicity consuming fairly typical western diets. There are few published~     controlled dietary intervention studies which have attempted to determine appropriate~     dietary patterns for the treatment of diabetes amongst populations consuming rice-based~     diets.~      HYPOTHESIS~        1. The glycaemic response over 6 days as measured by CGMS will have a lower mean glucose~          level and postprandial increase in individuals consuming the LGI compared with the SDI~          meal plan.~        2. A LGI meal plan is acceptable and participants will adhere and comply to the diet to~          the same level as those receiving the SDI meal plan.~        3. Glycaemic and metabolic parameters as measured by integrated area under the curve~          (IAUC) of glucose and insulin are lower after a single meal comprising of LGI than~          compared with an SDI meal.~        4. The effect of a single meal of LGI reduces appetite and increases satiety compared with~          a meal of SDI.~   "
112342|NCT01585805|"~     This randomized phase II trial studies how well veliparib together with gemcitabine~     hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone~     in treating patients with pancreatic cancer that has spread from where it started to nearby~     tissue or lymph nodes (locally advanced) or spread from the primary site (place where it~     started) to other places in the body (metastatic). Veliparib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. It is not yet known whether giving veliparib together with gemcitabine~     hydrochloride and cisplatin is an effective treatment for pancreatic cancer.~   "
112343|NCT01585792|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875~     in diabetic patients.~   "
112344|NCT01585779|"~     The purpose of this study is to gather clinical information on the hemodynamic performance~     of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.~   "
112345|NCT01585766|"~     The purpose of this study is to evaluate the safety and tolerability of ascending~     intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing~     forms of multiple sclerosis (MS).~   "
112346|NCT01585753|"~     This is a substudy of MARCH, in which we are exploring the changes in the vascular~     endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure~     the changes in small and large arterial elasticity in participants of the MARCH study who~     switch to maraviroc-based regimens over 96 weeks of follow-up.~   "
112348|NCT01585727|"~     One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which~     is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs~     for diagnostics and treatment of short and long-term urogenital dysfunction are immense.~     Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with~     rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).~      The study will examine the impact of a newly developed continuous monitoring device for~     preservation of urogenital function in patients with TME for rectal cancer. 188 patients~     will be included in the prospective, randomized, single-blind, parallel group multi-centre~     trial including two arms (TME with and without intraoperative continuous monitoring of~     pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function~     measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital~     functions measured as secondary endpoints. The application of the continuous intraoperative~     neuromonitoring device could enhance the objective intraoperative confirmation of pelvic~     nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes~     the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An~     enormous reduction of treatment costs is to be expected.~   "
112349|NCT01585701|"~     The purpose of this first clinical study of the noval multiple AGC kinase inhibitor,~     AT13148, is to identify the recommended dose for future studies in cancer patients by~     exploring the safety and maximum tolerated dose and biological effects in patients with~     advanced solid tumours.~   "
112350|NCT01585688|"~     The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to~     determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated~     dosing schedule). The secondary objectives are to obtain information on efficacy,~     pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose~     for subsequent studies.~   "
112351|NCT01585675|"~     The primary objective of the protocol is to develop a comprehensive specimen banking program~     from patients with lung cancer for future translation research, which will enable the~     investigators to detect lung cancer earlier, develop better therapies and explore screening~     and prevention strategies.~   "
112352|NCT01585662|"~     EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to~     place several stents to drain the content of cyst into GI tract. In the investigators~     experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than~     placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified~     naso-pancreatic tube drainage method were found recurrent with a follow up period from 3~     months-34 months. So, the investigators designed this prospective random comparing study to~     confirm the result.~   "
112353|NCT01585649|"~     This is a Phase I, open label study aimed at assessing the pharmacokinetics,~     pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in~     children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy~     (CTX)~   "
112354|NCT01585636|"~     This is a phase 1, first in man study to evaluate single oral doses (5-300 mg) of SQ109, a~     new investigational drug being developed for treatment of tuberculosis. If single doses are~     safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy~     volunteers and patients with pulmonary tuberculosis.~   "
112355|NCT01585623|"~     Primary Objective:~        -  To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the~          cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).~        -  To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.~      Secondary Objectives:~        -  To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in~          Segment 1~        -  To characterize the safety and tolerability of 28-day consecutive doses of 500 mg~          SAR302503 in Segment 2~        -  To determine antitumor activity in Segment 2~   "
112356|NCT01585610|"~     The purpose of this study is to determine if a newly designed DVD program performs better~     than standard, printed quit-smoking materials to help smokers who have mobility limitations~     (e.g., use a cane, wheelchair, braces, crutches, prosthesis) to quit smoking.~   "
112357|NCT01585597|"~     The purpose of this study is to determine whether reducing a patients body temperature (mild~     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury~     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a~     significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).~   "
112358|NCT01585584|"~     The purpose of this study is to test the potential antiviral efficacy of triple-combination~     therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype~     3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).~   "
112359|NCT01585571|"~     The results of this study will have an impact upon public heath policy as adults with~     cerebral palsy (CP) present a growing and underserved population in the United States. At~     the conclusion of this study, we will have identified the means by which the adult with CP~     maintains their upright position, which is essential for activities of daily living and for~     movement. With this knowledge, it will be possible to develop clinical and rehabilitation~     interventions that will improve their arm and leg function, and reduce the risk of falls for~     the adult with CP.~   "
112360|NCT01585558|"~     The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily~     doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal~     women with an intact uterus.~   "
112361|NCT01585545|"~     The purpose of this study is to evaluate relationships between multiparametric imaging~     biomarkers and genetic analysis in NSCLC patients.~   "
112362|NCT01585532|"~     Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis~     specific nucleic acid in urine and blood of patients.~   "
112364|NCT01585506|"~     This study is conducted in Europe. The aim of this study is to investigate psychosocial~     factors related to compliance with treatment with biphasic insulin analogues.~   "
112716|NCT01580826|"~     We hypothesize that short term infection-related benefits of human milk feeding are~     decreased by the process of pasteurization. Primary objective of the study is to compare the~     incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive~     either pasteurized or raw expressed mothers'own milk.~   "
112365|NCT01585493|"~     Schizophrenia is a life shortening disease, not only because of suicide but also because of~     increased mortality from natural causes. Recently, a large register-based study, involving~     complete national data from Denmark, Sweden and Finland, showed that life expectancy for~     schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the~     general population, and that mortality from medical conditions and diseases are responsible~     for a large proportion of the reduced life expectancy. Patients with schizophrenia had a~     twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases,~     lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated~     physical disorders play an important role in this excess mortality.Results from the Danish~     National Indicator Project for Schizophrenia showed that a much higher proportion of~     patients with schizophrenia compared to the general population have measures of waist~     circumference, body mass index, blood pressure, blood lipids and blood glucoses above the~     recommended upper values.~      In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two~     different interventions both aiming to reduce risk for death from medical diseases. We will~     compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to~     connect the patient to general practice and primary care and 3) affiliation to a staff~     member from the CHANGE team who should facilitate life style changes and contact with~     general practice. The objective is to identify interventions that can reduce the risk of~     early death in patients with schizophrenia.~   "
112366|NCT01585480|"~     The purpose of this research study is to develop, implement, and evaluate a multi-component~     obesity prevention program in a workplace setting. A quasi-experimental design will be~     utilized, with hospital employees receiving the intervention and clinic employees serving as~     the comparison group. It is hypothesized that the intervention group will see greater~     changes in healthier eating, increased participation in physical activity, and reduced risk~     for obesity (weight, BMI, waist circumference).~   "
112367|NCT01585467|"~     To compare and validate the two clinical algorithms~   "
112368|NCT01585454|"~     Background:~      - Women can gain too much weight or develop diabetes during pregnancy. If the mother is~     overweight or has diabetes during pregnancy, her baby may also be at risk of being~     overweight or developing diabetes. A woman s chance of getting diabetes increases if her~     parents or family members are overweight or have diabetes. Poor diet and exercise habits can~     also lead to weight gain and diabetes. Researchers want to study how best to improve the~     health of pregnant women and their children. They will do so by providing healthy lifestyle~     counseling for women receiving prenatal care at the Phoenix Indian Medical Center.~      Objectives:~      - To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic~     pregnant women.~      Eligibility:~        -  Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian~          Medical Center.~        -  Participants must be overweight or obese. They may or may not have diabetes.~      Design:~        -  Participants will receive standard prenatal care from the midwives, doctors, and~          dietitians at the Phoenix Indian Medical Center.~        -  Participants will work with National Institutes of Health staff for about 2 hours every~          week. These sessions may include phone calls, home visits, or group meetings.~        -  Participants will have a total of nine measurement visits. The first visit will be at~          or before 16 weeks of pregnancy. The next three visits will be within a week of the~          first visit. Another four visits will take place between 23 and 28 weeks of pregnancy.~        -  Participants will have different tests through their pregnancy. They will wear heart~          monitors and wrist monitors to measure heart rate and movement. They will provide~          information on their eating habits, physical activity, and mood and feelings during~          pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.~        -  Participants will receive counseling on healthy eating and physical activity habits.~          They will be encouraged to invite friends or family members to learn more about healthy~          lifestyle choices.~        -  The study will end with the final visit about 6 to 8 weeks after giving birth. A final~          blood sample will be collected. Participants will be asked questions about mood and~          feelings.~   "
112369|NCT01585441|"~     Background:~        -  Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under~          the retina. It affects the macula, which is in the center of the retina and is needed~          for sharp, clear vision. In many cases, CSC resolves on its own and does not need~          treatment. However, in some cases it does not go away or comes back after treatment.~          This is known as chronic CSC.~        -  Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can~          alter the effects certain of androgens. Researchers want to compare finasteride with a~          placebo to see if it is a safe and effective treatment for chronic CSC.~      Objectives:~      - To see if finasteride is a safe and effective treatment for chronic CSC.~      Eligibility:~      - Individuals at least 18 years of age who have chronic CSC in one or both eyes.~      Design:~        -  Participants will be screened with a physical exam and medical history. A full eye exam~          will be performed. Blood and urine samples will also be collected.~        -  Some participants may have photodynamic therapy (PDT), the standard treatment for CSC.~          PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for~          3 months after PDT before starting the finasteride study.~        -  Participants will be separated into two groups. One group will take finasteride 5 mg~          (formulated into capsules); the other group will take a placebo capsule. All~          participants will take the capsules for 3 months.~        -  After 3 months on the assigned capsule (finasteride or placebo), all participants will~          have the opportunity to take finasteride for at least another 4 years and 9 months.~          This phase of the study is optional.~        -  Participants will have regular study visits. At each visit, they will have physical~          exams and eye exams. They will also provide blood and urine samples.~        -  During the first 3 months, participants will have 2 study visits. After 3 months, if~          the participant continues in the optional (or as needed) phase of the protocol, visits~          will occur at Month 6, Month 12 and every 12 months thereafter. However, additional~          visits may be needed.~   "
112370|NCT01585428|"~     Background:~      The human papillomavirus (HPV) can cause a number of cancers, including cervical and throat~     cancers. The NCI Surgery Branch has developed an experimental therapy that involves taking~     white blood cells from patients' tumors, growing them in the laboratory in large numbers,~     and then giving the cells back to the patient. These cells are called Tumor Infiltrating~     Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with~     melanoma. Researchers want to know if TIL shrink s tumors in people with HPV-related cancer.~     In this study, we are selecting a specific subset of white blood cells from the tumor that~     we think are the most effective in fighting tumors and will use only these cells in making~     the tumor fighting cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause HPV-related cancers to shrink and to see if this treatment is safe.~      Eligibility:~      - Adults age 18-66 with HPV-related cancer who have a tumor that can be safely removed.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed.~      Surgery: If the patients meet all of the requirements for the study they will undergo~     surgery to remove a tumor that can be used to grow the TIL product.~      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for~     the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital~     for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
112406|NCT01584934|"~     Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by~     physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very~     common in CFS patients, however, the relationship between (disturbed) sleep quality and~     fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue~     and to explore the interdependence of sleep quality and fatigue in CFS, a double blind,~     randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS~     patients.~      The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as~     a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying~     medical or psychiatric illness. The answer to this question may shed further light on the~     enigmatic relationship between sleep and fatigue. We also want to investigate the effect of~     sodium oxybate on sleepiness and general health in the same target population.~      Zero-hypothesis: there is no effect.~   "
112371|NCT01585415|"~     Background:~      - One possible treatment for advanced melanoma involves collecting white blood cells from~     the person with cancer and growing them in a laboratory. The cells can then be given back to~     the donor. This study will use this white blood cell treatment with the cancer treatment~     drug vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene,~     and may be able to make them shrink.~      Objectives:~      - To see if vemurafenib and white blood cell therapy is a safe and effective treatment for~     advanced melanoma.~      Eligibility:~      - Individuals at least 18 years and less than or equal to 66 years of age who have advanced~     melanoma that contains the B-raf genetic mutation.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  White blood cells will be collected from tumor cells. These cells will be collected~          during surgery or a tumor biopsy.~        -  Participants will have leukapheresis to collect additional white blood cells for the~          procedure.~        -  Participants will take vemurafenib twice a day, starting 3 weeks before receiving the~          white blood cells.~        -  Participants will have 1 week of chemotherapy to prepare their immune system to accept~          the white blood cells.~        -  Participants will receive an infusion of their collected white blood cells. They will~          also receive aldesleukin for up to 5 days to boost the immune system s response to the~          white blood cells. They will remain in the hospital until they have recovered from the~          treatment.~        -  Participants will have frequent follow-up visits to monitor the outcome of the~          treatment.~   "
112372|NCT01585402|"~     Background:~        -  Arterial Calcifications due to Deficiency in CD73 (ACDC) is a rare genetic disease.~          People with ACDC develop calcium deposits in the arteries and joints of the fingers,~          wrists, ankles and feet. These deposits cause severe pain in the hands and feet, even~          when the person is at rest, and may lead to loss of the affected hand or foot.~          Currently, there are no standard treatments for ACDC.~        -  Etidronate is a drug that helps to slow or stop the natural process that dissolves bone~          tissue. It is approved to treat Paget s disease, a condition in which the bones are~          soft and weak and may be deformed, painful, or easily broken. It is also used to treat~          high blood calcium levels. Researchers want to see if it can be used to treat the~          symptoms of ACDC and improve pain and blood flow in the hands and feet.~      Objectives:~      - To see if etridronate is a safe and effective treatment for ACDC.~      Eligibility:~      - People between 18 and 80 years of age who have been diagnosed with ACDC.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have imaging studies, including x-rays and DEXA bone scans, before starting treatment.~          Blood and urine samples will be collected. An exercise tolerance test will also be~          given.~        -  Participants will take etridronate by mouth once a day for 14 days every 3 months. They~          will be assigned an individualized 6-month drug schedule to follow. Participants should~          not eat foods that are high in calcium for at least 2 hours after taking the study~          drug.~        -  Participants will have regular study visits throughout the treatment period. These~          visits will involve imaging studies, full dental exams, and blood and urine tests.~          Participants will also have exercise tolerance tests and arm and leg blood pressure~          tests to measure pain and blood flow.~        -  Participants may also provide tissue samples for further study.~        -  Treatment will continue for up to 3 years as long as the side effects are not severe~          and the condition does not become worse. Participants will have a final follow-up visit~          after stopping treatment.~   "
112373|NCT01585389|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to brain tumors.~      PURPOSE: This research studies gene expression and location in samples from patients with~     brain tumors.~   "
112374|NCT01585376|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and find biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies genes in samples from younger patients with~     rhabdomyosarcoma.~   "
112375|NCT01585350|"~     The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1)~     combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and~     Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to~     test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at~     whether the experimental vaccine and these drugs cause any changes to the immune system.~   "
112376|NCT01585337|"~     The hypotheses of this study are as follows:~        1. There is no significant muscle activity difference of each muscle in patients between~          pre and post operation.~        2. There is no significant forward reach distance/average velocity difference in patients~          between pre and post operation.~        3. There is no significant standard deviation of center of pressure (COP) along x axis,~          speed of COP along y axis during the task and COP path during the 3-sec holding phase~          difference in patients between pre and post operation.~        4. There is no significant muscle activity difference between muscles on both sides at~          post operation.~   "
112377|NCT01585324|"~     This open-label, multicenter, phase IV study will evaluate the relationship between the drop~     in hemoglobin levels and sustained virological response in patients with chronic hepatitis C~     genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients~     will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously~     weekly. Anticipated time on study treatment, depending on virological response, will be 48~     or 72 weeks.~   "
112378|NCT01585311|"~     The purpose of this retrospective study is to test the hypothesis that uncontrolled~     tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after~     Subarachnoid Hemorrhage (SAH).~   "
112379|NCT01585298|"~     Study to evaluate bradycardiac events during first dose observation of fingolimod in MS~     patients~   "
112380|NCT01585285|"~     The purpose of the AMI-PONT trial is to assess whether the results in term of graft patency~     with a novel coronary artery bypass (CABG) strategy, including a saphenous vein bridge to~     distribute the arterial flow of the left anterior mammary artery (LIMA) to all the~     anterolateral territory, are not inferior than a conventional CABG strategy combining~     separated LIMA graft to left anterior descending coronary and vein graft for other target~     vessels of the anterolateral territory.~   "
112427|NCT01584661|"~     Objectives:~        1. To determine the level of compliance with nutritional recommendations (dietary and~          nutritional supplements) following discharge from hospitalization;~        2. To identify barriers for post-discharge adherence to professional nutritional~          recommendations;~        3. To determine the impact of adherence (high vs. low) to the nutritional treatment~          guidelines on functional and health indicators.~      Working hypothesis:~      High adherence to nutritional care after hospitalization will be associated with better~     functional and health outcomes.~   "
112767|NCT01580150|"~     The purpose of this study is to investigate whether berries are effective in lowering blood~     glucose and insulin responses to meals containing starch or sucrose.~   "
112381|NCT01585272|"~     This phase IIIb study is intended to implement a consistent treatment way for switching to~     Exelon transdermal patch from oral formulation of rivastigmine to stress the importance of~     (1) advantages of transdermal patch over conventional oral therapies: smooth drug delivery~     with reduced side effects;(2) encourage treatment compliance in the Alzheimer's dementia~     setting.~      This study is a single-arm, treatment-switched design. Eligible patients, who are under~     Exelon capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed~     by treatment switch from oral capsule to patch for 48 weeks maintenance treatment. During~     the maintenance period, the treatment will be initiated with Exelon Patch 4.6 mg/24 hours~     (Exelon Patch 5 cm^2) for the first 24 weeks and the dose will be escalated to Exelon Patch~     9.5 mg/24 hours (Exelon Patch 10 cm^2) for another 24 weeks if well tolerated. Visits to~     assess safety are scheduled at baseline, 3 days, 1 week and 2 weeks after the first~     treatment switch, every 4 weeks until Week 40, and at the end of study (Week 52). The~     assessment to address the primary objective will focus on the safety of treatment switching~     (Week 0~28); however the safety assessment will be performed during the whole study period.~   "
112382|NCT01585259|"~     Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction~     patients~   "
112383|NCT01585246|"~     The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing~     the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms~     will be recorded each week, as well as assessment of quality of life through: 1) Physical~     Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional~     Well-Being.~   "
112384|NCT01585233|"~     The purpose of this study is to explore the safety and tolerability of multiple doses of~     ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects~     with moderate to severe psoriasis.~   "
112385|NCT01585220|"~     This study design is a randomized, multi-center, double Masked, matched Pairs,~     active-controlled clinical trial. Subjects who voluntarily signed the informed consent and~     are judged to be eligible for this study will be intradermally injected both of study device~     and comparator device. Subjects will be randomized to receive injection of study device and~     comparator device on their each nasolabial fold. Efficacy is evaluated based on the change~     in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24~     weeks follow up visits and subject diary which will be given to subjects during the first 2~     weeks after the injection. Any uncomfortable things and adverse events will be investigated~     from subeject diary and follow up visits.~   "
112386|NCT01585207|"~     The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication,~     will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted~     into adulthood and have not responded to usual treatment.~   "
112387|NCT01585194|"~     The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to~     control uveal melanoma.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow~     the body's immune system to work against tumor cells.~   "
112388|NCT01585181|"~     The purpose of this study is to compare the safety and immunogenicity of a single dose of~     the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether~     PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in~     the same household.~   "
112389|NCT01585168|"~     This project compares Family History Positive (FHP) for alcoholism subjects to matched~     Family History Negative (FHN) subjects derived from the project Principal Investigator's~     National Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking~     behavior in a 2000 college freshman population (known as the Brain and Alcohol Research in~     College Students study (BARCS)). The age of these subjects is a valuable one at which to~     capture the transition from harmful use to abuse/dependence. This project explores the~     effects of memantine in a double-blind, randomized, counterbalanced manner on alcoholism~     risk-relevant tasks. More specifically, this project studies functional MRI tasks related to~     different aspects of reward and/or impulsivity-related behavior in different contexts,~     compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the~     glutamatergic system to examine NMDA/DA interactions. The combined measures provide the~     opportunity to advance our understanding of specific aspects of brain function related to~     familial alcoholism vulnerability in an already well-characterized population as some~     members evolve into alcohol abuse. In addition to conventional within-task analyses,~     functional network connectivity and allied approaches will be used to examine brain networks~     across tasks.~      The investigators will study adult male and female subjects in equal numbers who are either~     offspring of an alcoholic parent or are FHN matched controls. The investigators will recruit~     and assess a total of 84 (42 FHP and 42 matched FHN) subjects between the ages of 18-21~     years on initial BARCS contact. The investigators will use 4 cognitive tasks during the~     functional MRI (fMRI) which include: 1) a Monetary Incentive Delay Task that distinguishes~     networks engaged in motivational (anticipation) and consummatory (outcome) components of~     reward processing; 2) a Go/No-Go Task that measures the ability to inhibit response to a~     pre-potent stimulus; 3) an Alcohol Cue Reactivity Task that examines Nucleus Accumbens~     response to alcohol-related versus matched soft drink stimuli; and 4) a~     Pavlovian-to-Instrumental Transfer (PIT) Task that dissects a component of the Monetary~     Incentive Delay (MID) Task, and provides an imaging assay of a transfer-like process that~     can be related to real-world drinking behavior, thus informing upon and extending the key~     findings from CTNA-2.~   "
112390|NCT01585155|"~     The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity~     index (CAI) score and other evaluation indicators in pediatric patients with moderate to~     severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2,~     and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also~     evaluated.~   "
112391|NCT01585142|"~     The purpose of this study is to assess the growth of infants fed with BabyNes System,~     compared to the World Health Organization Reference, during the first four months of life.~   "
112392|NCT01585129|"~     To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for~     pregnancies with treated chorioamnionitis.~   "
112393|NCT01585103|"~     Whether the cytosponge will be a useful non-invasive tool in evaluating patients with~     eosinophilic esophagitis?~   "
112442|NCT01584466|"~     Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and~     nonadherence, which is one of the most problematic issues. People with schizophrenia and~     substance use disorders (SUDs) are at an increased risk nonadherence compared to those who~     do not use alcohol and illicit drugs. The investigators propose that this new marketed~     injectable antipsychotic with many benefits over other available long acting injectable~     agents would be beneficial in the dually diagnosed population and may represent a specific~     schizophrenia subpopulation where long acting agents may be considered an important~     therapeutic option.~   "
112394|NCT01585090|"~     Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female~     pelvic floor dysfunction. Actually the best position to facilitate PFM force is~     controversial in different studies. The aim of this study is to assess the effect of ankle~     positions on pelvic ﬂoor muscle force during PFM exercises.~      This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of~     pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad~     University of Medical Sciences in 1389. After clinical examination and confirmation of~     pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing~     strengthening exercises of PFM in standing position with passive ankle dorsi ﬂexion (on~     wooden surface with 15 degree angle)(n=20), active ankle plantar ﬂexion with arm up~     (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises~     were instructed to women by using a pamphlet and face to face education. They were followed~     up every two week by telephone call and were asked to refer to women's clinic after 4 & 8~     weeks. Pelvic floor muscles strength was assessed with brink score before and after~     intervention. Data analyzed by using analytic-descriptive statistics.~   "
112395|NCT01585077|"~     This study is a randomized clinical trial designed to compare the susceptibility of naive~     and pre-immune volunteers to infectious challenge with viable Plasmodium vivax sporozoites.~     The term preimmune hereafter denoted only previous experience with infection by this~     parasite and not a definite state of immunity to malaria infection. The study hypothesis is~     that pre-immune volunteers present a delayed onset of malaria clinical and parasitological~     manifestations when compared to naive individuals. The development of this study will~     establish a protocol for evaluating the effectiveness of vaccine candidates against P. vivax~     in subsequent Phases IIa and IIb clinical trials.~   "
112396|NCT01585064|"~     The purpose of this trial is to assess the effect of two Intensive Outpatient Management~     Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid~     Arthritis (RA) that are treated with adalimumab.~      This is a multi-center, randomized, controlled, parallel group, single (patient) blind~     trial. A total of 300 patients (100 per group) with RA will be recruited from approximately~     40 sites across Canada.~   "
112397|NCT01585051|"~     The effect of administration of vitamin D is tested on the long-term control of blood sugar~     (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour~     blood pressure profiles)in patients with stable type 2 diabetes mellitus~   "
112398|NCT01585038|"~     The purpose of this study is to compare the cardiovascular profiles of efavirenz and~     rilpivirine, which are two drugs used to treat HIV infection.~   "
112399|NCT01585025|"~     The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile~     acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid~     or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that~     patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast~     Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid~     synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether~     OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective~     treatment.~   "
112400|NCT01585012|"~     This is a human factors usability study designed to validated usability by obtaining~     feedback in a home use environment regarding ease of use of the Focus Touch™ Conception~     System Conceptacle (when used to collect semen) and the instructions for use. The~     investigators will collect data to demonstrate that the usability requirements of the~     conception system as collection device, as determined by Usability Specification: Focus~     Touch Conception System, ER-000001 have been met. The ability of the device to be used~     during sexual intercourse without discomfort or injury to the female participant's~     vaginal/cervical tissues shall also be taken into account. Participating couples will be~     asked to use the Focus Touch™ Conception System Conceptacle (in condom form), using the~     Instructions For Use, to collect semen during sexual intercourse in a home use environment.~     This study will involve sexual intercourse between monogamous, heterosexual couples who are~     trying to conceive or are on a non-vaginal birth control with which they do not normally use~     condoms. Participants will be asked to complete the study and the questionnaire within 3~     days of receiving the study packet. Contact information shall be collected, but participants~     will only be contacted if they fail to return the questionnaire within the requested~     timeframe.~   "
112401|NCT01584999|"~     Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three~     types of RBCs: 1- fresh standard RBCs (storage <10 days); 2-leukodepleted RBCs and 3-old~     standard RBCs (storage >15 days) respectively. Before and 1 hour after the transfusion,~     microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed~     Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate,~     mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.~   "
112402|NCT01584986|"~     Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an~     emerging treatment modality for no-option patients with peripheral artery disease (PAD). The~     purpose of this study was to assess safety and efficacy of ex vivo expanded, peripheral~     blood-derived, autologous angiogenic cell precursors (ACPs) in no-option PAD patients.~   "
112403|NCT01584973|"~     Stair negotiation is an important activity of daily living. Patients with cruciate ligament~     injury may have difficulty in stair negotiation because of the proprioception deficit and~     neuromuscular deficit caused by ligament injury. However, the influence of knee cruciate~     ligament injury on the control of movement is still unclear. Since inter-joint coordination~     can provide the information of relationship between angle position and angle velocity, it~     may be useful to analysis the change of movement pattern.This current study aimed to~     investigate the change of inter-joint coordination and muscle activation in patients with~     cruciate ligament injury during stair negotiation.~   "
112404|NCT01584960|"~     The aim of the present study is to investigate the effect of endurance on PSA doubling time~     in prostate cancer patients with an elevation in PSA following radical prostatectomy for~     localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory~     markers and improvement in insulin sensitivity and body composition are investigated.~   "
112405|NCT01584947|"~     The aim of the project is to do a fase two trial, where the effect of a local anesthetic~     lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste~     as well as investigate a potential antiinflammatory effect in patients with burning mouth~     syndrome, Sjögrens syndrome and lichen planus.~   "
112407|NCT01584921|"~     Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to~     the bloodstream EPO binds to its receptor predominantly located within the bone marrow where~     erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO)~     down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies~     revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in~     glomerular filtration rate (GFR). These results for the first time demonstrate a link~     between EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn~     results in rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the~     major oxygen consuming factor in the kidney. The expected result will be an increase of the~     oxygen tension in the environment of renal EPO producing cells, in this way initiating an~     appropriate signal for down-regulation of endogenous EPO synthesis when circulating levels~     of EPO are high.~      The aim of this project is to test this hypothesis by investigating the renal effects of~     rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo,~     or low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium~     balance studies will be conducted together with renal clearance studies for measurements of~     renal plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA~     clearance) and the segmentel tubular handling of sodium and water (lithium clearance).~      EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the~     project will provide new information about basic physiological issues regarding the~     association between renal function and the regulation of EPO synthesis.~   "
112408|NCT01584908|"~     Influenza is an important public health problem. Organ transplant patients are particularly~     susceptible to severe disease. Also, they shed higher quantities of virus for longer~     durations, leading to greater contagious potential, thereby potentially serving as nodes of~     spread in the community. Therefore, improved strategies to prevent influenza in this~     population is an important public health concern. Standard vaccination is poorly immunogenic~     post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules~     that create a strong local inflammatory response and they attract immune cells to the site~     of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal~     influenza vaccines containing adjuvants have become available in Canada but have only~     limited information in transplant patients. This randomized trial is designed to assess the~     immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for~     seasonal influenza in a cohort of adult organ transplant recipients.~   "
112409|NCT01584895|"~     Cardiac rehabilitation programs improve mortality, functional capacity, and quality of life,~     for a variety of patients with heart disease. It stands to reason that patients with LVADs~     might therefore also benefit from the same structured exercise training, education, and~     clinical surveillance. One potential benefit of cardiac rehabilitation in this patient~     population is reversal of the skeletal muscle atrophy that occurs due to extended periods of~     poor peripheral perfusion (i.e. before implantation) and prolonged sedentary behavior.~      Purpose: The purpose of this proposed study is to examine the effects of a 6-week exercise~     program on cardiorespiratory fitness, quality of life, and device flow rate in patients with~     recently implanted LVADs.~      Methods: 30 patients with recently implanted LVADs will be referred by the Henry Ford~     Hospital Advanced Heart Failure Program once the patient is deemed appropriate for exercise.~     Before enrollment into cardiac rehabilitation patients will undergo a six minute walk test~     and graded exercise stress test on a treadmill to determine exercise capacity. Additionally,~     a quality of life questionnaire will be given.~      Following the stress test, patients will be randomized (2 to 1 ratio) into either cardiac~     rehabilitation or control. Those chosen to be in the control group will be encouraged to~     maintain daily activities; those in the rehabilitation group will partake in 6 weeks of a~     standard cardiac rehabilitation program. This will consist of 3 days a week of supervised~     exercise as well as education regarding diet and lifestyle modifications.~      At 6 weeks after randomization both groups will again undergo fitness assessments and retake~     the quality of life questionnaires.~   "
112410|NCT01584882|"~     Electronic dental records (EDR) are a potentially powerful tool to incorporate current~     scientific evidence into clinical practice by providing key information at the point of~     patient care. The investigators know that disseminating evidence-based guidelines is not~     sufficient to change clinical practice so innovative approaches need to be tested in~     dentistry. The composite expertise of the investigators and consultants on this project and~     a large group practice with multiple clinics utilizing one EDR are essential to address the~     aims of this study. This project will examine whether dentists and hygienists will assess~     interest in quitting and deliver a tobacco intervention more frequently when provided with~     computer assisted guidance compared to a control group. Specifically the investigators will~     measure the delivery of questions assessing willingness to change and appropriate~     interventions based on willingness to change by measuring the recording of these activities~     in the EDR and patient receipt of these recommendations through a phone survey. In addition,~     the study will do a qualitative assessment of the patient perceived value of the~     provider-patient encounter to further inform us about patient perception of this~     interaction. The investigators want to know if dental providers will utilize these tools~     during the dental encounter. If they are used, the investigators would propose further~     studies examining smoking cessation rates. The investigators were not able to measure~     cessation rates due to the short two year timeline of this funding mechanism. This tool has~     potential application for other clinical topics, which makes this approach very innovative~     when considering the translation of evidence into the unique clinical practice of dentistry.~   "
112411|NCT01584869|"~     Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe~     GI-Bleeding.~   "
112464|NCT01584167|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain~     swelling associated cerebrovascular disease. The narrow-time-frame is a major issue (time~     is brain). To provide immediate cooling without delay, easy to use, mobile and effective~     methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS~     Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive~     surface cooling system. A comparison of these two induction methods has never been done~     before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the~     first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.~   "
112412|NCT01584856|"~     It is known that small dense LDL particles are associated with an increased cardiovascular~     risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to~     their size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects~     with small dense LDL particles compared to subjects with large LDL particles. This study~     aims at evaluating the predictive value of small dense LDL particles in patients with~     prediabetes and type 2 diabetes mellitus concerning future changes in intima media~     thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin~     resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the~     study. Assessment will include medical history (risk factors), physical examination (blood~     pressure, BMI, waist-to-hip ratio), collection of serum, oral glucose tolerance test,~     measurement of intima media thickness and endothelial dysfunction by ultrasound. All~     measurements will be repeated after 2 years. Data will be analysed to assess whether the~     amount of small dense LDL particles can predict further structural and functional changes of~     the cardiovascular system or changes in the severity of the disease (insulin resistance).~   "
112413|NCT01584843|"~     Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820~     compared with non-treatment in patients with strabismus based on angles of strabismus in the~     primary position.~   "
112414|NCT01584830|"~     The purpose of this study is to assess if Regorafenib in combination with best supportive~     care will slow down tumor progression and result in increased survival in patients with~     metastatic colorectal cancer.~   "
112415|NCT01584817|"~     Cell phone retell the instruction of bowel preparation on the day before colonoscopy would~     help patient to prepare for colonoscopy and improve the quality of the bowel preparation.~   "
112416|NCT01584804|"~     This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough~     variant asthma.~      The investigators hypothesize:~      Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang~     antitussive capsule.~   "
112417|NCT01584791|"~     The aim of the current study is to compare the antiplatelet efficacy and safety of~     clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients~     after coronary stent implantation.~   "
112418|NCT01584778|"~     Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported~     to reflect eosinophil activity. Few studies have examined the role of eosinophils in the~     pathogenesis of Behçet's disease. The purpose of the present study is to investigate the~     serum ECP levels in BD and its relation to clinical activity.~   "
112419|NCT01584765|"~     Drug re-administration or rechallenge should be avoided after drug-induced liver injury~     (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug~     and patient subjects. In order to better predict these outcomes, the objective of this~     analysis is to assess clinical outcomes of positive drug rechallenge following possible~     drug-induced liver injury. Electronic medical records from Kaiser Permanente California~     (KPSC), a managed care organization, will be utilized to identify patients who experience~     possible drug-induced liver injury following exposure to medications associated with~     hepatotoxicity, and who are then rechallenged with the medication.~   "
112420|NCT01584752|"~     This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high~     transsphincteric fistulas. Follow-up time is six months~   "
112421|NCT01584739|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation~     of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given~     once daily.~   "
112422|NCT01584726|"~     The purpose of this study is to investigate the use of magnesium sulfate nebulization in~     patient with moderate to severe asthma exacerbation in pediatric emergency.~   "
112423|NCT01584713|"~     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the~     treatment of enterocutaneous fistula.~   "
112424|NCT01584700|"~     Heart failure is a common condition with debilitating symptoms and a poor prognosis.~     Patients with heart failure have a massively overactive sympathetic nervous system which~     attempts to compensate for their poorly functioning heart. This ultimately has only~     detrimental effects.~      One of the principle mediators for this sympathetic response is found in the nerve cells in~     the kidneys. Whilst a significant proportion of medications used to treat heart failure act~     on these harmful pathways, none target the kidney sympathetic-nerve cells specifically.~     Additionally, because of their multiple sites of action these drugs all have side effects.~      A new procedure that has recently been developed for the treatment of high blood pressure is~     renal denervation. This involves inserting a small catheter through the femoral artery and~     passing it to the kidney artery under x-ray guidance. From there, using radiofrequency~     waves, the sympathetic nerves within the kidney can be destroyed.~      The investigators anticipate that this procedure will have a significant positive effect on~     patients with heart failure and aim to perform a pilot safety study on 7 individuals with~     advanced heart failure to assess its safety and effectiveness. The investigators hypothesise~     that renal artery denervation will lead to significant clinical and biochemical improvements~     in patients with marked heart failure.~   "
112425|NCT01584687|"~     Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and~     monitor the response to omalizumab in patients with difficult control asthma 2. Identify~     which genes are switched on and which are switched off by using Omalizumab.~      Methods: This study is an open label clinical trial, with six patients. The patients will~     receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days)~     for 4 months. There will be a run-in period of one month, when allergic asthma diagnosis~     will be confirmed and treatment will be optimized. Patients will be evaluated and will have~     blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the~     end of the study. Blood samples will always be collected one week after the last omalizumab~     dose. Primary outcome will be RNA expression of 20 genes measured by real time-PCR~     (high-affinity IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between~     others). Secondary outcomes will be ACT, ACQ and spirometry.~   "
112426|NCT01584674|"~     The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic~     System in patients with moderate to severe facial acne vulgaris using a split-face design~     (treated hemiface vs untreated hemiface).~   "
112428|NCT01584648|"~     This is a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib~     (GSK2118436) and trametinib (GSK1120212) combination therapy to dabrafenib administered with~     a trametinib placebo (dabrafenib monotherapy). Subjects with histologically confirmed~     cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K~     mutation positive will be screened for eligibility. Subjects who have had prior systemic~     anti-cancer treatment in the advanced or metastatic setting will not be eligible although~     prior systemic treatment in the adjuvant setting will be allowed. Approximately 340 subjects~     will be randomized 1:1 (combination therapy: dabrafenib monotherapy). Subjects will be~     stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus~     less than or equal to the ULN) and BRAF mutation (V600E versus V600K). The primary endpoint~     is investigator-assessed, progression-free survival for subjects receiving the combination~     therapy compared with those receiving dabrafenib monotherapy. Subjects will be followed for~     overall survival; crossover will not be permitted.~   "
112429|NCT01584635|"~     Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less~     invasive treatment for Achalasia has been developed.~      The purpose of this study is to decide the role this less invasive treatment (Peroral~     Endoscopic Myotomy) has in the treatment of patient's with achalasia.~   "
112430|NCT01584622|"~     The purpose of the study is to evaluate the effectiveness of the CADence system, a~     non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in~     the coronary tree.~   "
112431|NCT01584609|"~     This is a prospective, randomized, single blind, concurrent controlled, multi-center study.~     Patients presenting with symptoms of acute ischemic stroke who have evidence of a large~     vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned~     to either the Penumbra System with the Separator 3D or the Penumbra System without the~     Separator 3D. Each treated patient will be followed and assessed for 3 months after~     randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute~     ischemic stroke in vessels accessible to the Penumbra Separator 3D System for~     revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the~     safety and effectiveness of the Penumbra System with the Separator 3D for the~     revascularization of large vessel occlusion is not inferior to the Penumbra System alone.~   "
112432|NCT01584596|"~     The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight~     and obesity, which are the result of long-term disruptions in energy imbalance where dietary~     energy intake has exceeded energy expenditure associated with physical activity. To address~     this issue, the overall goal of this project is to determine ways in which the U.S.~     Department of Health and Human Services and U.S. Department of Agriculture Dietary~     Guidelines for Americans (2005) physical activity recommendations can be effectively adapted~     for the LMD population. Phase I of this study was completed in early 2011.~   "
112433|NCT01584583|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 22 cm-36 cm.~   "
112434|NCT01584570|"~     The purpose of this study is to investigate effect of dexmedetomidine and tracheal~     intubation on heart rate variability and QTc interval.~   "
112435|NCT01584557|"~     The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in~     subjects hospitalized for worsening heart failure who have volume overload and one of the~     following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.~     The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8~     and 16 hours.~   "
112436|NCT01584544|"~     This phase I study is designed to determine the maximum tolerant dose of capecitabine when~     used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75~     years old.~   "
112437|NCT01584531|"~     The primary objectives of this study are to determine if rigosertib sodium, given orally in~     the form of soft gel capsules, is safe and is associated with a reduction in the number of~     blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS)~     classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2~     (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent.~     Rigosertib will be taken on days 1 to 21 of a 21-day cycle.~   "
112438|NCT01584518|"~     The long-range goal of this proposal is to decrease morbidity and mortality related to~     pulmonary edema and congestive heart failure (CHF) in post-operative patients. The~     short-range goal is to determine a mechanistic endpoint when therapy for impending heart~     failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels.~     The investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.~   "
112439|NCT01584505|"~     Cardiac Safety Study~   "
112440|NCT01584492|"~     The purpose of this clinical study is to compare the improvement in breathing of single~     administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug~     beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with~     spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose~     100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)~     given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.~      Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to~     placebo and the effect on other lung function parameters, to assess the safety and~     tolerability of CHF 1535 dosages in children.~   "
112441|NCT01584479|"~     This study is one component of a program to improve the maintenance of good dental health~     and the prevention of disease by use of risk stratification methods to efficiently guide~     increased preventive services to adult dental patients who are at increased risk for the~     major dental diseases, caries and adult periodontitis.~      The investigators will use a retrospective cohort model to analyze a large dental claims~     database to determine if the frequency of preventive services influenced the periodontal~     disease outcomes and to determine if periodontal risk assessment information can be used to~     stratify dental patients into high risk and low risk categories that influence the~     effect of preventive services on periodontitis outcomes.~      Primary Objective To evaluate whether dental patients who are classified as low risk for~     periodontal disease progression, based on history of periodontitis (claims history),~     smoking, diabetes, and IL-1 genetic variations, have different primary and secondary~     endpoints if they had two dental cleanings per year compared to one cleaning per year.~      Secondary Objectives To evaluate whether dental patients who are classified as high risk~     for periodontal disease progression, based on a history of periodontitis, smoking, diabetes,~     and IL-1 genetic variations, have different primary and secondary endpoints if they had two~     dental cleanings per year compared to one cleaning per year.~      To evaluate whether dental patients who have had one dental cleaning per year have different~     primary and secondary endpoints if they are classified as low risk for periodontal disease~     compared to patients who are classified as high risk. To evaluate whether dental patients~     who have had two dental cleaning per year have different primary and secondary endpoints if~     they are classified as low risk for periodontal disease compared to patients who are~     classified as high risk.~   "
112465|NCT01584154|"~     The purpose of this study is to compare the safety and effectiveness of cryoablation and~     radiofrequency ablation in the treatment of the commonest kind of supraventricular~     tachycardia, namely atrioventricular nodal reentrant tachycardia. The study hypothesis is~     that cryoablation is non-inferior to radiofrequency.~   "
112443|NCT01584453|"~     Despite advances in the treatment of heart attacks the complications and death rates from~     failure of the heart to pump properly after treatment remain high. A heart attack occurs~     when one or more of the arteries that supply blood to the heart become blocked, causing the~     heart to be starved of oxygen and nutrients. This results in damage to the heart and so the~     the heart pumps less well. The main treatment for a heart attack is balloon treatment to~     open the blocked artery (called primary angioplasty). Whilst re-opening the artery is~     essential and allows blood to flow to the area of the heart starved of oxygen, this process~     also causes damage itself (called reperfusion injury) and increases the size of the heart~     attack further. Currently there are no treatments available that reduce this reperfusion~     injury. The investigators and others have shown that a substance called sodium nitrite~     reduces reperfusion injury in experimental models of a heart attack. The aim of this~     research is to perform a trial to investigate whether during a heart attack, an infusion of~     sodium nitrite into the damaged artery protects against reperfusion injury and reduces heart~     attack size in patients.~   "
112444|NCT01584440|"~     The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923~     compared to placebo, for the treatment of symptoms of agitation in patients with Alzheimer's~     Disease (AD).~   "
112445|NCT01584427|"~     Background Life style related disease is an increasing problem all over the world. The~     Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood~     lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high~     risk of developing Type 2 Diabetes and cardiovascular disease.~      Dietary fibers have been shown to have positive effects on the components of MetS. The~     investigators have special interest in the combination of two types of fiber (Resistant (RS)~     starch and Arabinoxylans (AX)) .~      Hypotheses Increase of RS and AX in the dietary composition has a positive effects on~     components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and~     markers of inflammation.~      The subjects undergo two dietary interventions of 4 weeks duration each: A Healthy~     Carbohydrate Diet with a high content of RS and AX is compared to a Western Style Diet~     with a low content of RS and AX.~   "
112446|NCT01584414|"~     Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and~     neoplastic cells. Because of the potential importance of such a capability, the~     investigators undertook to investigate Zetiq's CellDetect® staining technology as applied to~     cultured cell lines as well as an initial sample of clinical cases. This goal was pursued by~     investigating four types of comparisons: 1) cancer cell lines before and after~     differentiation; 2) cervical squamous-cell carcinoma (SCC) biopsies to non-neoplastic~     squamous epithelium; 3) SCCs to neoplastic, nonmalignant squamous epithelium; and 4)~     neoplastic squamous cells to non-neoplastic squamous cells in cytological preparations. The~     clinical material was also stained with hematoxylin and eosin (biopsies) or Pap (cytologies)~     for diagnostic purposes. The investigators found that all CellDetect®-stained cells~     exhibited one of the two tinctorial outcomes. Cell lines with malignant phenotype uniformly~     had red/purple cytoplasm, whereas the differentiated phenotype changed the color to~     blue/green.~   "
112447|NCT01584401|"~     Main study objectives:~        1. To compare the temperature measured using Medisim's thermometers to the temperature~          measured using mercury or equivalent reference thermometers.~        2. To develop more accurate algorithms for measuring on the forehead as well as behind the~          ear.~        3. To test the difference between various forehead measurement locations in order to allow~          more convenient measuring that is not depended on the exact location.~   "
112448|NCT01584388|"~     The primary objective of this study is to evaluate the safety and effectiveness of rituximab~     in IgG4-RD.~   "
112449|NCT01584375|"~     Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences~     of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head~     to one side may increase intracranial pressure and occlude major ipsilateral veins in the~     neck, which could increase cerebral venous pressure and decrease cerebral venous drainage.~     Keeping preterm infants' heads in a slightly elevated midline position (side or supine)~     during the first 168 hours(HOL) has been recommended as one of the 10 potentially better~     practices to reduce the incidence of IVH in preterm infants. To the best of our knowledge,~     there has been no systematically collected clinical data quantifying the relationship~     between IVH and head position in preterm infants. However, the midline head position may~     challenge the well-known right neonatal head position preference. This preference continues~     until 3-6 months of age, after which preterm neonates keep their heads mainly in midline.~     The best head position for preterm neonates is still to be determined. Therefore, the~     investigators are aiming to conduct a large scale multicenter randomized control trial on~     order to answer the following research question: Does keeping heads of preterm infants less~     than 30 weeks of gestation in flat midline (FM) throughout the first 168 HOL reduce the risk~     of IVH compared to right flat lateral (rFL)? We hypothesized that keeping heads of preterm~     infants less than 30 weeks of gestation in FM throughout the first 168 HOL would reduce the~     risk of IVH compared to rFL.~   "
112450|NCT01584362|"~     This research is being done to learn about the safety in humans of a medicine that is~     already used in cows and pigs to treat worms. The medicine may be useful for people who have~     these or other worms. The medicine will be studied first in healthy people, who will be~     given a very small amount of the medicine once. If the smallest amount of medicine is found~     to be safe, a slightly higher amount will be given to a new group of volunteers. The highest~     amount that will be tested is similar to the amount given to animals. If the medicine can be~     given safely to healthy people in the planned amounts, a later study will be done in people~     who have worms to see if the medicine kills the worms.~   "
112451|NCT01584336|"~     The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted~     total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This~     study will performed via prospective, multicenter design.~   "
112452|NCT01584323|"~     In this study the investigators sought to determine the effects of Pomegranate (Natural~     pomegranate polyphenol (P. granatum L) extract) :~        1. On the maternal and fetal oxidative stress and inflammation associated with PPROM.~        2. On the time interval from PPROM to delivery and on fetal Ph and apger score.~   "
115917|NCT01538849|"~     This study is to investigate the optimal clinical dose and administration methods of YH4808~     in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral~     administration.~   "
112453|NCT01584310|"~     Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss~     or insufficient weight gain, is related to an increase in morbidity and mortality and~     exposes the child to medical complications. In addition, obesity is also related to~     complications during hospitalization and complications in general, and therefore early~     identification of these children is extremely important. Studies show that malnutrition is~     frequent among children upon hospitalization, where the risk of pediatric nutritional~     deterioration increases, even in the presence of mild stress factors. This risk is frequent~     mainly among children that arrive at the hospital with an initial poor nutritional status.~     Improving the nutritional status as part of the standard of care already at the ambulatory~     setting might improve the prognosis of children when ill. In Israel, nutritional screening~     in not conducted among children since there is no proper validated screening tool. Study~     objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk~     which is designed to be used by nurses, and to compare it to a complete nutritional~     assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the~     investigators wish to examine the effects of using a screening tool for nutritional risk on~     the medical staff's attention to the nutritional status; this is measured by the collection~     of nutritional status-related data and their recording in the patient file.~      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric~     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3~     questions with a summary score, according to which the nutritional risk level shall be~     determined. These children shall also undergo a complete dietician assessment in order to~     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the~     beginning of the research and after 6 months in order to estimate the change in medical~     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to~     nutritional status- related tests and recording of anthropometric measurements.~      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using~     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi~     square test.~   "
112454|NCT01584297|"~     Our proposal is to conduct an open phase II clinical trial that allows us to explore the~     activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors~     similar to what has been done in prostate cancer. The rational is based on dysregulation~     that FOXL2 mutations present in almost all granulosa tumors result in the expression of~     CYP17 that appears to be key in the development and progression of the disease.~      This work would represent the first attempt to address the treatment of ovarian granulosa~     cancer with a molecular solid rational, drawing on the recent identification of the mutation~     leader of this tumor. If succeed provide a widely available therapeutic alternative~     compared with current cancer therapies, with low toxicity. In addition it would open a new~     line of research with CYP17 enzyme inhibitors that could alter the course and outcome,~     usually fatal, in advanced stages of disease.~   "
112455|NCT01584284|"~     The purpose of this study is to determine the safety and tolerability of GL-ONC1~     administered intravenously in combination with radiation therapy and cisplatin (CDDP)in~     patients with locoregionally advanced head and neck cancer.~   "
112456|NCT01584271|"~     Phase II 3 arm double blinded clinical study, to evaluate pain killing and healing time of~     Botanical Ear Drops, Ear Comfort™, in Severe External Ear Infection (AOE) patients in~     comparison to Dex-Otic® and Otidin®.~      Study Outcome (hypothesis): if Ear Comfort™ proves to perform as well as Dex-Otic, then~     ENT's and family doctors will have a botanical non-antibiotic product that does not promote~     the formation of antibiotic-resistant infections and may be given to anti-biotics sensitive~     patients.~      Ear comfort™ is pharmacologically stable for at least 3 years on the shelves.~   "
112457|NCT01584258|"~     This study is an international multicentre randomised study of organ confined low and~     intermediate risk prostate cancer and is composed of two parallel randomisation schemes~     based on applicability of surgery as a treatment for the patient. Patients for whom surgery~     is a consideration are randomised to either laparoscopic prostatectomy or prostate SBRT.~     Patients for whom surgery is not a consideration are randomised to either conventionally~     fractionated radiation therapy or prostate SBRT. Efficacy, toxicity and quality of life~     outcomes will be compared across the pairs in each randomisation.~   "
112458|NCT01584245|"~     This clinical trial will evaluate the efficacy of an amino acid formula in infants with~     allergic manifestations.~   "
112459|NCT01584232|"~     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265~     (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic~     medication (OAM).~   "
112460|NCT01584219|"~     Immature myeloid cells (IMCs) that are generated in the bone marrow, and differentiate into~     mature granulocytes, macrophages and dendritic cells (DCs) in the steady state. Recently, it~     was demonstrated that the IMC population expands in malignancy, both in animal models and in~     humans. These cells were described as immunosuppressants but have also been shown to promote~     tumor angiogenesis. Accordingly, IMCs were also found to take part in the burn injury wound~     healing process and other pathologies that involve angiogenesis. It was shown in the~     investigators' laboratory, that a very similar population of IMCs populates the mouse and~     human placenta, and that these cells actively promote angiogenesis.~      Dendritic cells (DCs) that can differentiate from IMCs, are antigen presenting cells (APCs)~     that initiate and coordinate the innate and adaptive immune responses. DCs can take up a~     diverse array of antigens and present them to T cells as peptides bound to MHC products.~     These antigen-specific responses are critical for resistance to infection and tumors.~     Conversely, DCs have roles in autoimmunity, transplant rejection and immunological~     tolerance. In the reproductive system, DCs were shown to account for 5%-10% of all~     hematopoietic cells in the uterine decidua at the embryonic implantation site. They were~     shown to promote angiogenesis during early pregnancy, especially during implantation. Very~     little is known about their function in the placenta and in the latter part of pregnancy~     when significant angiogenesis takes part.~      The investigators' preliminary mouse experiments and human data, demonstrate a shift in~     IMC/DC populations with the development of the placenta. The investigators hypothesize that~     this population shift may contribute to the labor and delivery process.~      The investigators' aim is to understand the role of these myeloid cell populations during~     pregnancy, to characterize their phenotype and try to shed light on the cellular and~     molecular mechanisms of pregnancy complications, such as preeclampsia, pre-term labor,~     intrauterine growth restriction, etc.~   "
112461|NCT01584206|"~     Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an~     inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this~     study is to determine if ezetimibe improves whole body plant sterol and cholesterol~     homeostasis.~   "
112462|NCT01584193|"~     The purpose of this study is to compare two different surgical techniques for implementation~     of totally implantable central venous access ports. Ultrasound-guided suclavian vein~     puncture is compared to cephalic vein dissection.~   "
112463|NCT01584180|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain~     swelling associated cerebrovascular disease. The narrow-time-frame is a major issue (time~     is brain). To provide immediate cooling without delay, easy to use, mobile and effective~     methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS~     Brain.Pad (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive~     surface cooling system. A comparison of these two induction methods has never been done~     before. Neither was the effect of the EMCOOLS Brain.Pad on brain-temperature measured. For~     the first time iCOOL 3 compares feasibility, safety and efficacy of the two methods.~   "
114145|NCT01562119|"~     The present study was to retrospectively evaluate the long-term outcomes of the cograft~     acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of~     functional regional wounds in burned patients.~   "
112466|NCT01584141|"~     Background:~      - Lymphoma rates in Asia have been lower than in the West, but rates have been rising in~     recent years. Most studies of lymphoma patients have been conducted in the West. Less~     information is available about the factors that might contribute to the rise of lymphoma in~     Asia. Researchers want to collect medical and personal histories and samples from people who~     have recently been diagnosed with lymphoma. This information will help them study possible~     reasons for this increase.~      Objectives:~      - To collect samples and histories as part of an introductory study of lymphoma in Asia.~      Eligibility:~        -  People between 18 and 79 years of age who have entered study hospitals in Hong Kong,~          Taiwan, and mainland China for treatment for any type of lymphoma.~        -  Healthy volunteers between 18 and 79 who have never had lymphoma.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  They will provide blood samples and cheek cell samples for testing.~        -  Participants will complete a questionnaire about their personal health history. They~          will answer questions about exposures to chemicals like pesticides. They will also be~          asked about family medical history and work and residential history. Finally they will~          answer questions about lifestyle factors like diet and exercise.~        -  They will give permission for the researchers to see their medical records. Researchers~          will also have access to any tumor samples collected as part of treatment.~   "
112467|NCT01584128|"~     The goal of the investigators study is to determine whether the use of oxidized regenerated~     cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff~     dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize~     that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff~     cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic~     hysterectomy.~   "
112468|NCT01584115|"~     This study is a clinical trial phase I/II. Its goal is to determine the safety,~     tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen~     NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.~   "
112469|NCT01584102|"~     The intervention included biweekly access to group fitness classes, with (Group 1) or~     without (Group 2) weekly nutrition and physical activity education sessions. Outcome~     measures were assessed at baseline and immediately post intervention and included BMI, waist~     circumference, blood pressure, physical activity and dietary behaviors, and psychosocial~     variables.~   "
112470|NCT01584076|"~     Amblyopia is the leading cause of monocular visual impairment in children and adults.~     Despite conventional treatment with patching or eye drops, many older children and adults do~     not achieve normal vision in the amblyopic eye.~      Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter~     acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by~     the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's~     Hospital to improve vision and reverse amblyopia in animal models.~      The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for~     residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.~   "
112471|NCT01584063|"~     Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial~     that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce~     risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to~     the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and~     2006 in southwest Detroit.~   "
112472|NCT01584050|"~     Folic acid, a form of the vitamin folate, is added to grain products in Canada to help~     reduce birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't~     break down) when added to foods. There are emerging health concerns about chronic folic acid~     consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate~     (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women~     to determine if supplements containing L-MTHF consumed over three months raises blood folate~     levels as much as supplements containing folic acid. The investigators hypothesize that~     L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.~   "
112473|NCT01584037|"~     The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect~     data concerning:~        1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,~        2. Potential confounding factors, and~        3. The outcome of these pregnancies.~      The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the~     frequency of birth defects in prospectively enrolled pregnant women. This Registry is also~     designed to detect any unusual patterns of birth defects.~   "
112474|NCT01584024|"~     The purpose of this study is to determine whether lesion infiltration is an effective~     management strategy to arrest early tooth decay.~   "
112475|NCT01584011|"~     Objectives~      To evaluate the impact of taste disturbance in different types of chronic middle ear~     diseases and after middle ear surgery.~      Hypothesis~      That patients with chronic otitis media and cholesteatoma has taste disturbance already~     before surgery due to the disease itself, of course depending on degree of the disease.~      That patients with otosclerosis, has a normal nerve function before surgery.~      That patients with normal taste before surgery are more likely to notices a taste~     disturbance.~      That nerve in continuity after surgery, even if it is maltreated, gives less taste~     disturbance than a divided nerve.~      Methods~      A clinical study has been launched that measures taste function with two different methods~     for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD)~     before and after middle ear surgery in patients operated with middle ear surgery because of~     otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120~     patients in this study.~      A parallel study of the patients own experience of the symptom has also been launched were~     the patients answer a questionary and a quality of life document. The investigators plan to~     include 300 patients in this study.~      A histological study where specimens of CTN from healthy ears and from ears with chronic~     disease will be investigated with electron microscopy has also started.~   "
112495|NCT01583725|"~     The investigators are looking at the differences in appetite and obesity between weight loss~     participants and patients undergoing bariatric surgery.~      Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether~     or not they intend to undergo bariatric surgery.~   "
112476|NCT01583998|"~     The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT~     Southwestern MyChart personal health record is feasible, associated with patient and health~     care team satisfaction, and improves treatment outcomes compared to a standard treatment~     model. The project will be conducted in the Simmons Cancer Center Clinic at the University~     of Texas Southwestern Medical Center, Dallas as a collaborative effort between the~     Departments of Psychiatry, Oncology, and Family and Community Medicine. The primary patient~     population will include adults with significant depression and/or starting an antidepressant~     treatment and/or experiencing a treatment change. The study will compare two groups, an~     e-MBC group and an office-based standard care MBC group. Study staff will explain the study~     to the patients, specifically explaining that study participants will receive either~     office-based MBC or e-MBC. Eligible participants must be willing to receive either form of~     treatment monitoring. Participating patients will be randomly assigned to receive either~     e-MBC or office-based MBC. In the e-MBC group once a month the study nurse will send a~     prompt from the participating patients treating physician requesting the patient to use the~     MyChart system to fill-out the MBC scales. Beyond these monthly assessments, patients will~     be encouraged to utilize the MyChart MBC assessments (e-MBC) at any time to communicate with~     their physician. Patients experiencing difficulties using the e-MBC system will be given~     additional instruction by the study nurse. Patients and physicians will be trained in the~     use of the eMBC system. In the office-based MBC group the study nurse will schedule monthly~     treatment visits and request the patient call as needed to report symptoms. The evaluation~     period will be 6 months.~   "
112477|NCT01583985|"~     Chronic musculoskeletal pain conditions are among the most prevalent conditions in VA~     primary care. Over the past two decades, improved clinical attention to pain has been~     associated with exponentially greater use of long-term opioid therapy for chronic non-cancer~     pain, both within and outside the VA system. Despite this change in practice, the proper~     place of opioids in chronic pain management continues to be controversial because research~     has not demonstrated the long-term safety and effectiveness of opioids for chronic~     musculoskeletal pain. The Strategies for Prescribing Analgesics Comparative Effectiveness~     (SPACE) Trial will fill a critical gap in the evidence by comparing effectiveness and harms~     of two clinically relevant analgesic prescribing strategies-one that emphasizes early use of~     strong opioids and one that delays and minimizes opioid use-for Veterans with chronic back,~     hip, or knee pain. SPACE is designed to be highly relevant to clinical decision-making in VA~     primary care and to produce knowledge that will improve the lives of Veterans living with~     chronic pain.~   "
112478|NCT01583972|"~     Vitamin A supplementation at birth may increase survival of infants through one year of age~     by reducing mortality from infectious diseases, though current studies are not conclusive on~     this point. The goal of our study is to determine if supplementation of newborn infants with~     50,000 IU of vitamin A improves aspects of immune function that may be impaired by vitamin A~     deficiency. Our underlying assumption is that supplementation may thus decrease risk of~     death by improving immune function and the ability to survive infections. This project will~     be limited to the examination of the impact of vitamin A on immune function and will not aim~     to determine the impact on morbidity or mortality, which would require larger sample sizes.~     The hypotheses addressed by this study are as follows: Provision of vitamin A supplements to~     newborns at risk of vitamin A deficiency will (1) improve functioning of the thymus (the~     source of T lymphocytes, cells of the immune system that are important in response to~     infection and immunization); (2) enhance T lymphocyte-mediated responses to standard~     vaccines given at birth and early in infancy; and (3) improve gut barrier function (i.e.,~     ability to prevent bacterial infection across the epithelial barrier), relative to provision~     of a placebo.~   "
112479|NCT01583959|"~     Introduction: Methotrexate is the sheet anchor for the treatment of rheumatoid arthritis.~     Folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate~     adverse effects. Patients at our center are usually on the higher dose. However, it is~     unclear if higher doses are required, recent international recommendations suggest 5-10 mg~     per week only.~      Objectives: To randomize rheumatoid patients being being started on Methotrexate into 2~     groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice~     a week (10 mg per week) for 24weeks. To look at difference in~        1. Adverse effects due to methotrexate~           a. Minor adverse effects: By symptom chart~           a. Major adverse effects: Cytopenia (predefined) and transaminitis.~        2. Disease activity using Disease activity score 28 joints (3 variable) and functional~          status by health assessment questionnaire~        3. RBC folic acid levels Methodology: Randomised controlled trial, double blinded, placebo~          controlled. Sample size 50 in each group. One group of patients will receive folic acid~          5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5~          mg 6 days a week for 24 weeks.~      Patients will be administered adverse effects proforma, assessed for having cytopenias and~     transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in~     the beginning at then at 8,16 and 24 weeks. In addition will look at the functional status~     and RBC folate levels at 0 and 24 weeks. Statistical analysis using chi-square test for~     proportions and t test for continuous variables.~   "
112506|NCT01583582|"~     The purpose of this proof of concept study is to find out the efficacy of Marealis Refined~     Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing~     ACE-inhibiting peptides on blood pressure in subjects with mild or moderate hypertension.~   "
112507|NCT01583569|"~     Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the~     relationship between voice samples, heart rate, respiration, movement, galvanic skin~     conductance, and sleep architecture with mood states in patients with Major Depressive~     Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear~     dynamic analyses will be able to reveal hidden patterns of complexity in each domain of~     voice, heart rate variability, movement, arousal, and sleep stage data.~   "
112649|NCT01581710|"~     Primary hypothesis: Montelukast will decrease bronchial hyperresponsiveness in subjects with~     persistent allergic rhinitis when compared with those treated with placebo in a double-~     blind, placebo-controlled, cross-over 5-week randomized trial.~      Secondary hypothesis: There will be a significant correlation between allergic rhinitis~     severity and bronchial hyperresponsiveness severity and baseline lung function measures.~      Tertiary hypothesis: Subjects who respond well to montelukast will have particular~     characteristics of allergic rhinitis when compared with those who do not respond to~     montelukast.~   "
112480|NCT01583946|"~     As individuals age, they undergo transitions in many aspects of their lives. These~     transitions include social, economic and health transitions. People review their lives, and~     reflect on past choices. Future time is limited by the increasing proximity to end of life.~     This may lead to regrets and, in people with the ability to use compensatory mechanisms, a~     redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the~     context of aging, individuals' past, present, and future-oriented subjective well-being~     (SWB) may change. There is an incomplete understanding of the relationship of SWB, intra-~     and inter-personal resources, and outcomes, (particularly health and healthcare-cost~     outcomes). These issues have complicated the use of SWB measures and the investigators are~     left with traditional metrics such as life expectancy, infant mortality, wealth, and poverty~     to assess healthy aging, resulting in an incomplete picture of healthy aging. This project~     will examine the relationships among SWB, intra- and inter-personal resources, and health~     and healthcare-cost outcomes. It will advance the understanding of SWB and its role in~     healthy aging in order to assist policy makers in valuing the potential benefits of~     improving SWB on health and healthcare costs. The investigators will accomplish this through~     the following specific aim:~      Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life~     transitions, and (2) affects outcomes after life transitions.~   "
112481|NCT01583933|"~     There are several factors involved in the decision and the retention plan, such as~     occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of~     the cusps and health of the tissues involved, relationships inclined planes, size of the~     arches, harmony of the arches, muscle pressure, interdental proximal contact, cell~     metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable~     decision making with respect to the retainer that offers the best features of containment~     and stability.~   "
112482|NCT01583920|"~     Radiation therapy is considered a standard treatment option for the management of localized~     prostate cancer. Among the 20-30% who recur, a proportion of them will present with an~     isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as~     a source for subsequent metastases. Salvage options available for isolated local recurrence~     include; temporary or permanent implantation of radioactive seeds into the prostate,~     complete removal of the prostate gland, use of low temperatures to treat the disease, and~     high frequency ultrasound to treat the disease. There are risks of complications associated~     with all these treatments, and there is presently no consensus as to which treatment is the~     best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of~     focal treatment of the prostate using temporary implantation of radioactive seeds into the~     prostate which the investigators hope will be less since the entire prostate is not treated.~   "
112483|NCT01583907|"~     The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on~     the nutritional status, body growth and tolerance acquisition in children with cow's milk~     allergy.~   "
112484|NCT01583894|"~     This study will collect pain-related information from chronic pain patients to gain an~     understanding of the prevalence of multi-site pain, and how it affects health outcomes like~     function, quality of life, depression, and anxiety.~   "
112485|NCT01583881|"~     Increasing evidence suggests an important role of activation of the sympathetic nervous~     system (SNS) in the clinical phenomena of heart failure with normal left ventricular~     ejection fraction and hypertension. The current study aims to evaluate efficacy and safety~     of renal sympathetic denervation for the modulation of the SNS in patients with heart~     failure with normal LV ejection fraction.~   "
112486|NCT01583855|"~     Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is~     treated by catheter ablation (making an ablation lesion or burn inside the heart using a~     fine wire (catheter)). A new system for manipulating the catheters has recently been~     introduced into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is~     designed to answer two primary questions: a) is the contact force (the force with which the~     catheter comes into contact with the heart) any different using the RCS to manual~     techniques,and b)are the resulting ablation lesions within the heart any different in terms~     of the volume and contiguity of the lesions produced. Additionally the investigators aim to~     determine how the two techniques compare in success (the proportion of patients whose heart~     rhythm disturbance is corrected by the procedure).~   "
112487|NCT01583842|"~     This is a pilot study with the primary purpose to describe organ dosimetry and acute~     toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with~     neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or~     refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.~     After all eligibility criteria are met, patients will receive a diagnostic imaging dose of~     124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent,~     planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as~     specified by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG~     PET-CT scan will be done to assess tumor sites 6 weeks after the patient has their MIBG~     therapy.~   "
112488|NCT01583829|"~     This study examines the efficacy of two computer-based attention training systems, one with~     and one without neurofeedback. The training systems intend to help children learn to focus~     and attend more effectively.~   "
112489|NCT01583816|"~     A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple~     Actinic Keratosis Lesions~   "
112490|NCT01583803|"~     Females have a lower incidence of hypertensive and cardiovascular disorders that may relate~     to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled~     with the help of oral bacteria to nitric oxide which is protective against vascular~     disorders. This study will test the hypothesis that females have different numbers and~     species of these nitrogen-oxide reducing bacteria.~   "
112491|NCT01583790|"~     The purpose of this study is to report data with patients after bariatric surgery.~   "
112492|NCT01583777|"~     The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of~     belinostat following IV administration in patients with a recurrent or progressive~     malignancy.~   "
112493|NCT01583751|"~     This study examines performing pilonidal sinus surgery minimal invasively with~     videoendoscopic approach.~   "
112494|NCT01583738|"~     Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.~   "
112496|NCT01583712|"~     Early diagnosis of acute Gastrointestinal Graft-versus-Host disease (aGI-GvHD) has a strong~     impact on morbidity and mortality of patients who underwent haematopoietic stem cell~     transplantation (HSCT). Recent results at the investigators department showed that mucosal~     biopsies from the small intestine have a high diagnostic yield for aGI-GvHD specific~     changes. By performing an enteroscopic examination, aGI-GvHD suspected patients can be~     prevented from colonoscopy and prior bowel preparation which is clinically important,~     considering the rather bad general condition of this patient group. To further reduce~     invasive procedures the investigators want to evaluate the in vivo histological features of~     aGI-GvHD in the small bowel. Therefore aGI-GvHD suspected patients will undergo confocal~     laser endomicroscopy of the upper GI-tract, including duodenum and jejunum, in the context~     of a prospective clinical pilot trial. The histological evaluation of biopsy samples taken~     from these sites will be used as comparable gold standard. Endomicroscopic aspects of~     patients with celiac disease, infectious enteritis, inflammatory bowel disease and healthy~     subjects should serve as controls. If it is possible to diagnose aGI-GvHD from~     endomicroscopic features of the small bowel alone, this could be another important step to~     improve the diagnostic management of post HSCT patients, especially when taking of biopsy~     samples is difficult because of a bad coagulation status. Additionally, an accurate~     diagnosis in vivo could lead to immediate treatment to prevent progression and site~     spreading of the disease.~   "
112497|NCT01583699|"~     Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue~     (MALT-lymphoma) represents a distinct clinical entity and is the most common form of~     extranodal lymphoma, with a predilection for the stomach. About 90% of gastric~     MALT-lymphomas are associated with infection with Helicobacter pylori (HP) and eradication~     of the pathogen leads to regression of the tumor in a high percentage of patients at early~     tumour stages. Nevertheless, following complete remission after HP-eradication, the risk of~     relapse justifies lifelong follow-up examinations. Supported by recent findings at the~     investigators department, endoscopic controls should include a close examination of the~     small bowel, as relapses can involve different gastrointestinal sites. To continue the~     investigators diagnostic approach as well as to further improve the detection rate of~     MALT-lymphoma relapses, the investigators plan to introduce the novel confocal laser~     endomicroscope (CLE) into the diagnostic management of MALT-lymphoma patients. In the~     context of a prospective clinical pilot trial the investigators aim to establish~     MALT-lymphoma specific CLE-markers that can be used for the in vivo diagnosis of the~     disease. Comparing endomicroscopic findings, drawn from the stomach and small bowel of 50~     MALT-lymphoma patients who will undergo staging or follow up endoscopies at the~     investigators department, to the histological evaluation of biopsy samples as present gold~     standard, the investigators want to determine whether CLE can provide reliable data for the~     accurate detection of MALT-lymphoma associated changes. Endomicroscopic aspects of patients~     with chronic gastritis, gastric adenocarcinoma and healthy subjects should serve as~     controls. In comparison to random biopsies which represent the current standard, the~     investigators aim to prove, whether endomicroscopy will find MALT-lymphoma lesions more~     accurately and thus help to spare patients unnecessary biopsies.~   "
112498|NCT01583686|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     metastatic cancer that involves taking white blood cells from the patient, growing them in~     the laboratory in large numbers, genetically modifying these specific cells with a type of~     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the~     patient. This type of therapy is called gene transfer. In this protocol, we are modifying~     the patient s white blood cells with a retrovirus that has the gene for anti-mesothelin~     incorporated in the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these tumor fighting cells (anti-mesothelin cells) cause metastatic cancer tumors to~     shrink.~      Eligibility:~      - Adults age 18-70 with metastatic cancer expressing the mesothelin molecule.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed~      Leukapheresis: If the patients meet all of the requirements for the study they will undergo~     leukapheresis to obtain white blood cells to make the anti-mesothelin cells. {Leukapheresis~     is a common procedure, which removes only the white blood cells from the patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for~     the conditioning chemotherapy, the anti-mesothelin cells, and aldesleukin. They will stay in~     the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
112499|NCT01583673|"~     The primary objective of the clinical trial is to compare growth in infants (expressed as~     weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially~     available hypoallergenic formula over a period of 4 months.~   "
112500|NCT01583660|"~     With the development of society, aged population is growing. Hip fracture is the most common~     disease for aged people. With the life being longer than before, incidence of this disease~     is growing. The mortality of this disease is high—— almost 10% patients will die within 1~     month, about 1/3 of patients will die within 12 months. About 20%-30% aged people who have~     hip fracture will die within one year.~      The damaged organs caused by excessive inflammatory is one of possible reasons to cause~     higher mortality. Therefore, the investigators imagined that if they gave medicines to~     patients in time to reduce the inflammatory level, the inflammatory might have less effects~     on organs, and the recovery could be improved.~      The investigators hypothesis on the basic research: the anti-inflammatory function of non~     steroidal antiinflammatory drugs (NSAIDs) can inhibit the inflammatory level of elderly hip~     fracture, so as to improve the recovery level and reduce the complicating disease and~     mortality. The investigators designed a clinic study to research NSAIDS' effects on~     inflammatory level and prognosis of elderly hip fracture.~   "
112501|NCT01583647|"~     The purpose of this study is to determine the pharmacokinetics of laropiprant following~     administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of~     MK-0524A in adolescents with heterozygous familial hypercholesterolemia.~   "
112502|NCT01583634|"~     Accuracy of the oximeter.~   "
112503|NCT01583621|"~     Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3~     supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.~      Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3~     supplementations on non-invasive vascular measures including pulse wave velocity (PWV),~     flow-mediated dilation (FMD), carotid arterial compliance (CAC), carotid Intima-Media~     Thickness (cIMT), and 24-hours Ambulatory Blood Pressure (ABP) monitoring as well as casual~     BP.~   "
112504|NCT01583608|"~     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting~     bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery~     lesions in all-day clinical practice.~   "
112505|NCT01583595|"~     Most patients with chronic lung disease underestimate their actual walking ability due to~     low confidence. To better understand the relationships between lung function, self-efficacy~     for walking (confidence in ability to walk a defined distance), actual walking ability for~     the same distance gait speed and physical activity level-PAL- (total energy~     expenditure/resting metabolic rate).~      Quality of life, self efficacy for activity questionnaires, physical activity level~     measurement, 4-meter gait speed and 6-minute walk distance will be measured.~   "
112508|NCT01583556|"~     Many common arm fractures have an excellent prognosis with little more than symptomatic~     treatment. When studying these fractures, investigators find that a substantial number of~     patients do not attend follow-up appointments. The difficulty of maneuvering in big cities,~     the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are~     all inconveniences that some patients might prefer to avoid. Building on prior research, it~     is appropriate to offer patients with common minor upper extremity fractures that have an~     excellent prognosis optional follow-up after the first visit. The plan would be to be~     available by phone, email and subsequent appointment at the patient's discretion if they~     felt that the recovery was off course. Benefit to individual participants is unlikely. The~     study will benefit the society as a whole, by providing a better understanding of these~     common fractures. It can also affect the economics of our health system by avoiding further~     follow-up appointments.~      Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury~     between patients that return for a second visit, and patients that do not.~      Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after~     injury between patients that return for a second visit, and patients that do not.~   "
112509|NCT01583543|"~     This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult~     participants with recurrent/metastatic Ewing's Sarcoma following failure of prior~     chemotherapy.~   "
112510|NCT01583530|"~     The purpose of this study is to measure the amount of belimumab in the blood when given as~     an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability~     of multiple injections under the skin in healthy subjects.~   "
112511|NCT01583517|"~     The therapeutic impact of ERCP with sphincterotomy in the management of patients with~     idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators~     conducted a single center, feasibility, randomized trial to determine 1) the role of~     pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy~     of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).~   "
112512|NCT01583504|"~     Hypothesis: High volume saline injections are an effective pain relieving treatment for~     people with longstanding pain in the achilles tendon which has not improved with a~     physiotherapy programme.~      Objective 1: To establish whether high volume saline injections are an effective treatment~     in decreasing pain for people with achilles tendinopathy~      Objective 2: To investigate whether high volume saline injections can improve day to day~     functioning, quality of life and the ultrasound appearances of the tendon for people with~     achilles tendinopathy~      Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction~     using a simple questionnaire.~      Objective 4: To follow up the cohort of people who have received the injection for 9 months~     and ascertain whether any benefits persisted, or if the symptoms recurred.~      Background: Achilles tendon disorders are a common problem for athletes with a lifetime risk~     of around 50%. They are also common for less active people with a lifetime risk of around~     6%.~      Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing~     and swelling of the tendon. Symptoms may occur with exercise at first but can progress to~     occurring at rest and interfering with day to day activities. When the problematic tendon is~     examined under the microscope, it usually shows signs of degeneration rather than~     inflammation - especially when symptoms have been persistent. An ultrasound scan will~     usually show that the tendon is swollen with an increased water content and a disorganised~     tendon structure.~      A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound,~     often shows areas of increased blood flow around the tendon. Studies have shown that when~     these areas of increased blood flow are present, the patient tends to be experiencing more~     pain and stiffness in the tendon. Under the microscope, these blood vessels are often~     accompanied by nerve fibres and it has been suggested that these newly growing nerve endings~     are responsible for the persistent pain that patients experience.~      There is robust evidence that a particular type of exercise programme (eccentric loading) is~     an effective treatment for achilles tendinopathy. These exercises involve taking weight on~     the tendon whilst it is being compressed rather than stretched - heel lowering exercises.~     Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45%~     of patients will still have symptoms. There is no clear consensus amongst doctors as to what~     is the best second line treatment to try for this group of people.~      A number of different treatments have been described in research literature to try to treat~     this group of people with persistent symptoms, although no firm conclusion can be reached.~     There have been 2 small trials of high volume saline injections which showed some promising~     potential for the treatment. The aim of this injection is to destroy the blood vessels and~     nerve endings that grow into the swollen tendon to reduce pain and allow people to move and~     exercise more normally using the tendon. These studies simply looked at before and after~     injection results and did not compare the injections to a placebo or other treatment. The~     aim of this project is to conduct a high quality comparison of this new type of injection~     against a more common steroid and local anaesthetic injection around the tendon sheath. The~     design of the trial is a double blind, randomised controlled trial. This means that neither~     the patient, nor the doctor collecting data on pain scores knows which treatment the~     participant has been given, allowing a fair comparison of the interventions.~      The main comparisons between the 2 groups will take place at a 6 week follow up appointment.~     Once outcome measures have been recorded by the blinded assessor, the participant will then~     be told which arm of the study they are on. If they previously received the control~     injection (steroid and local anaesthetic only)and they still have symptoms, they will at~     this stage be offered the high volume saline injection as well. The investigators will then~     follow all of the study participants up for 9 months to ascertain whether people show a~     persistent benefit from the treatment, or whether symptoms subsequently return.~      The full study protocol is available on request from the Principle Investigator, along with~     information leaflets, ethical approvals etc.~   "
112513|NCT01583491|"~     The purpose of this study is to determine the influence of platelet rich fibrin to reduction~     of periodontal problems after surgical removal of third molar.~   "
112514|NCT01583478|"~     The objective of the study is to compare the efficacy and duration of escalating doses of~     IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the~     eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female~     patients 18 years of age or older with moderate to severe glabellar rhytids at maximum~     contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a~     one-time dose to the treatment area.~      The efficacy endpoints will be determined by investigator and subject live assessment of the~     glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days~     post-injection, every month for 9 months following) using a validated 4 point photographic~     scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles~     [3]) used in previous studies. A written description of each photograph will be included to~     help standardize the application of the Photographic Scale.~   "
112515|NCT01583465|"~     The purpose of this study is to establish whether or not there is a clinical advantage to~     the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical~     Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine~     intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound~     healing will be assessed by a blinded observer and based upon a simple and subjective~     criteria: a) as expected, b) better than expected or c) worse than expected. The blinded~     observer is experienced in the care of the surgical patient and wound evaluation.~   "
112516|NCT01583452|"~     Post- operative ileus refers to the time after surgery before coordinated electromotor bowel~     function resumes. It's treatment and prevention may signify an elevated hospitalization cost~     and the exposure to the patient to adverse effects of drugs.~      The current clinical trial has as primary objective to prove the efficacy of chewing gum as~     a preventive measure of post-operative ileus in pediatric patients after gastrointestinal~     surgery through the determination of the time the patient takes to tolerate oral intake,~     pass flatus, present bowel movements and the time of hospital stay.~      Patients will be assigned either to the case group (chewing gum + standard treatment) or to~     the control group (standard treatment), in both of them time from the end of surgery to the~     moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any~     type of food) and is discharged from hospital; will be measured in hours and then analyzed~     to determine the validity of these data.~   "
112517|NCT01583439|"~     The goal of the Mochudi Prevention Project is to reduce the number of new HIV infections~     in the village of Mochudi, Botswana by promoting a comprehensive package of interventions~     that have proven to be effective in preventing the spread of HIV. This antiretroviral~     treatment (ART) clinical study is nested within the Mochudi Prevention Project, and is being~     conducted in the north-east segment (NES) of the village of Mochudi. The ART intervention~     component of the Mochudi Project is designed to determine the uptake of, adherence to, and~     feasibility of 3-drug combination ART as a component of a package of transmission prevention~     strategies. The hypotheses are 1) that ART (with 3 antiretrovirals from two classes of~     drugs) among participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable~     and safe and 2) Eighty percent of eligible participants will agree to start 3-drug ART.~   "
112526|NCT01583322|"~     Patients with extensive and bulky disease are often those whose initial surgery is delayed~     after 3 or 4 cycles of neo-adjuvant chemotherapy.~      In that case, there is, indeed, some concern to administer bevacizumab during the~     chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21~     days) of this monoclonal antibody and the interference of anti angiogenic agents with wound~     healing.~      Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant~     setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary~     experience in cancer did not show a trend for increased incidence of fistula or bowel~     perforation. For more details please refer to the investigator drug brochure for Vargatef®~     (Nintedanib).~      This trial will compare progression-free survival and surgical complications of 188 patients~     with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy~     (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef®~     (Nintedanib).~   "
112518|NCT01583426|"~     Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast~     cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6~     cycles of TAC based on previous large scale studies.~      Treatment of patients with HER2-positive disease should include also simultaneous~     application of trastuzumab.~      Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active~     agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a~     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require~     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated~     hypersensitivity reactions. This new formulation improves safety profile, allows higher~     dosing with shorter infusion duration, and produces higher tumor drug concentration.~      As neoadjuvant treatment does not only allow to compare competing treatment approaches with~     a very high quality (homogenous treatment population, precise assessment of response by~     histological assessment), but also to identify predictive markers, this trial will compare~     weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses.~      In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab~     additionally.~   "
112519|NCT01583413|"~     Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation~     associated with significant morbidity, including prolongation of mechanical ventilation and~     increased ICU and hospital length-of-stay. Numerous strategies have been proposed to~     decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use~     of daily sedative interruptions and daily spontaneous breathing trials can improve sedative~     management, decrease ventilator time, improve outcomes for mechanically ventilated~     patients,and possibly decrease VAP.Combining daily sedative interruption with daily~     spontaneous breathing trials confers additive improvement in ventilator days, intensive care~     days, and possibly mortality compared to daily spontaneous breathing trials alone.~      The primary aim of this study is to determine the impact of an opt-out protocol for paired~     daily sedative interruptions and spontaneous breathing trials on VAP rates using a new~     streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's~     proposed new surveillance definitions for ventilator-associated events to this quality~     improvement initiative. The study will be nested within the Epicenters Streamlined versus~     Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be~     participating in this intervention arm.~   "
112520|NCT01583400|"~     Primary care physicians have emerged as the predominant mental health care providers for~     diagnosing and treating depression. The majority of patients with mood disorders receive~     treatment in the primary care setting, within which approximately 10-30% of all patients~     present with a depressive disorder. Comprehensive 'Collaborative Care' models of depression~     management significantly improve depression outcomes and health-related quality of life.~     Core features of these programs include use of a trained depression care manager to closely~     coordinate with primary care clinicians, support treatment recommendations, provide patient~     education, conduct patient follow-up to ensure adequate treatment, and manage as-needed~     access to psychiatrists for patients with more complex presentations. Evidence based~     Collaborative Care models do not currently weave in the use of web-based or mobile~     technologies. These technologies offer unique features that may make collaborative~     depression care more effective. The digital health coaching program for depressive symptoms~     enhanced during Phase I of the current project is a web-based tool featuring video, text,~     links and graphics which provide patients with education, self-management techniques,~     tailored feedback, and tools for tracking treatment progress. The RESPECT-D (Re-engineering~     Systems of Primary Care Treatment of Depression) intervention is a collaborative depression~     management model for primary care. The primary objective of this project is to compare the~     efficacy of an enhanced Collaborative Care model for depression (RESPECT-D-E) to the~     standard model (RESPECT-D) for patients with minor and major depression and dysthymic~     disorder. This study will be a randomized controlled trial with 150 participants who are~     receiving antidepressant medication treatment in the primary care setting. The primary~     objectives are: reduction in subject reported depressive symptoms, improvement in subject~     reported health related quality of life and improvement in subject adherence to treatment~     regimen as demonstrated by self-report measures and clinician-administered assessment. The~     investigators hypothesize that compared to RESPECT-D at 12 weeks, participants randomized to~     RESPECT-D-E will demonstrate: a greater reduction in depressive symptoms, a greater~     improvement in health-related quality of life and a greater satisfaction with quality of~     depression care received.~   "
112521|NCT01583387|"~     The main purpose of the study is to assess the effect of water intake on the formation of~     4-ABP DNA adducts.~   "
112522|NCT01583374|"~     Apremilast is a new, orally available, small molecule drug that specifically inhibits~     phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical~     study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.~   "
112523|NCT01583361|"~     This is a randomized, multicenter, controlled trial to prove efficacy of S‐1 and Oxaliplatin~     as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.~      The primary endpoint is three-year free disease and the second primary includes five-year~     overall survival, safety and R0 resection rate.~   "
112524|NCT01583348|"~     While gold standard in the treatment of symptomatic gall stones is laparoscopic~     cholecystectomy with instruments introduced through multiple abdominal wall incisions,~     transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the~     abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective~     and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography~     is feasible during such procedure. This observational case series describes success and~     technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy.~     The investigators hypothesis is that cholangiography is feasible equal to conventional~     laparoscopic cholecystectomy.~   "
112525|NCT01583335|"~     Obesity prevention should remain a priority, although there is some evidence of a possible~     leveling off in some age groups across European countries and in USA, Japan and Australia.~     Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity~     in childhood is associated with psychological and social problems, low self-esteem,~     stigmatization and being teased and bullied by friends. Danish research suggests that the~     causes behind the increase in obesity occurrence are present already in early childhood, and~     that prevention of obesity therefore has to start early. Research has suggested that at~     least three sub-groups can be considered at high risk of becoming obese: Children with~     obesity among their 1st degree relatives; children with a high birth weight or children~     coming from socially disadvantaged families (low socioeconomic status). Earlier intervention~     programs has showed little effect in preventing excessive weight gain and knowledge on how~     to develop effective intervention programs that reduce overweight and obesity remains~     limited. It has been suggested that future prevention programs may be more successful if~     specifically targeting groups that are at high risk, as mention above, of excessive weight~     gain.~      Based on these suggestions, the Sund Start project was initiated. The purpose of the study~     was to determine whether aiming prevention towards 2-6 years old Danish children who were~     yet normal weight, but were considered predisposed to becoming overweight or obese could~     prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was~     possible to improve diet habits, increase physical activity, reduce stress and improve~     sleeping habits among children at high risk for later on overweight and obesity.~      The Sund Start project will contribute with knowledge about whether targeting normal~     weight, predisposed children is effective in preventing overweight and obesity, and if~     reduced stress and improved sleep, should be considered important new obesity prevention~     tools. Moreover, the project will contribute with knowledge about how to change lifestyle~     and its effects on development of overweight and obesity in high risk Danish preschool~     children.~   "
114146|NCT01562106|"~     The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence~     imaging in endometrial cancer staging by sentinel node assessment.~   "
112528|NCT01583296|"~     The research plan involves two aims: 1) Cultural adaptation of the Panic-Asthma Treatment~     and 2) a randomized, placebo-controlled pilot study. Participants will be primarily~     recruited from two major, inner-city hospitals in the Bronx, NY. Diagnosis of Panic Disorder~     (PD) will be based on the Structured Clinical Interview for DSM-IV. Diagnosis of asthma will~     be based on national guidelines. The first year of the project will be devoted to~     approximately 5 focus groups with Latino (primarily Puerto Rican) participants, pilot~     treatment and participant feedback. The protocol will be adapted based on key cultural~     issues that are systematically observed during Phase 1. During Years 2-3, 40 participants~     with PD and asthma will be randomized into two treatment arms: Panic-Asthma Treatment and an~     active placebo condition involving music therapy and paced breathing at resting respiration~     rates. Each treatment will involve 8 weekly sessions. An interviewer, who will be blind to~     treatment condition, will conduct assessments at pre-treatment, mid-treatment,~     post-treatment, and 3-month follow-up. The primary hypotheses are that participants in the~     Panic-Asthma treatment group will have greater decreases than subjects in the placebo~     condition on the PD severity scale and albuterol use (i.e., rescue asthma medication) from~     pre-test to post-test and across 3-month follow-up.~   "
112529|NCT01583283|"~     The purpose of this study is to determine the best dose of ACY-1215 in combination with~     lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple~     myeloma. Once determined, the purpose of this study will be to determine the efficacy of~     ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed~     multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.~   "
112530|NCT01583270|"~     Sedentary lifestyles and increasing obesity are main causes of the global increase in the~     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,~     particularly composition of carbohydrate play also a significant role. Barley, oat and rye~     may in addition to reducing the acute post prandial glucose response also reduce glucose~     response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect~     levels of satiety hormones. In contrast, our knowledge of the physiological effect of~     arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is~     limited in relation to second meal effects. The investigators also lack knowledge of the~     second meal effect of arabinoxyan in combination with rye kernels.~      Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the~     formation of short chain fatty acids and improve the glycemic response.~      The aim of the present study is to compare the effect of porridge test meals based on~     purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and~     semolina porridge as control on acute postprandial response as well as response at a~     subsequent standardized meal. The study will be conducted in subjects with the metabolic~     syndrome. The primary endpoint is glucose response. Secondary endpoints are the following~     items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics,~     breath hydrogen and subjective satiety feeling.~      This project will improve opportunities for identifying and designing foods with low GI that~     is particularly suited to people who are at high risk of developing T2DM. The investigators~     also expect to gain a greater understanding of the metabolic fingerprint, as seen after~     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods~     affect health by altering metabolic processes. This will give us a deeper insight into the~     metabolic processes that are necessary for maintaining normal glucose homeostasis~   "
112531|NCT01583257|"~     Background:~      Renal transplant recipients have a greater risk of morbidity and mortality primarily due to~     cardiovascular disease when compared to the general population. Cardiovascular disease is~     responsible for 50% to 60% percent of deaths amongst renal transplant population and death~     from cardiovascular disease is a leading cause of functioning graft loss.~      Physical activity is an effective form of secondary prevention in existing cardiovascular~     disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects~     overall on quality of life and well-being. Transplant patients who participated in regular~     cardiovascular exercise have significant more positive scores on the SF-36 Health Status~     Questionnaire in comparison to inactive transplant recipients.~      Active video gaming is evolving as an innovative method to increase physical activity.~     Active video gaming has supported physical activity in children and youth. There is however~     a paucity of literature examining interactive games as a means to facilitate physical~     activity and its impact on CVD and quality of life in the adult population nor any~     literature examining AVG and its impact on an adult surgical population.~      This pilot study is designed to determine if Active Video Gaming is feasible and is able to~     lead to behavioral modifications and Quality of Life improvement.~      Subject Selection:~      This is a pilot study during which 10 patients who have undergone renal transplant will be~     selected to exercise with Active Video Gaming for a duration of 3 months. The program~     activity will begin 6 months post surgery.~   "
112532|NCT01583244|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Orencia® so that the regulatory authority can manage the marketing approval~     properly.~   "
112533|NCT01583231|"~     The aim of this research is to examine if the brushless scrub is effective in reducing~     bioburden on the hands of the operating room (OR) personnel both with a prewash of one~     minute prior to scrub and without a prewash prior to scrub, and to compare the bioburden~     reduction between both methods.~      Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases~     bioburden than brushless scrub alone.~      Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after~     the application of the brushless scrub within 20 seconds of application for both groups.~      Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5~     minutes after application of the brushless scrub for both groups.~   "
112534|NCT01583218|"~     The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban~     can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for~     an acute medical illness and to compare these results with standard of care enoxaparin. The~     safety of betrixaban will also be studied.~   "
112577|NCT01582659|"~     Constipation is a condition often seen in children. Constipation is often associated with~     impaired quality of life of the child and of great concern among parents. Despite the fact~     that both diagnosis and treatment is a simple task, it is often seen that the treatment~     fails, and many children are referred to a pediatric ward for specialized treatment.~      There is currently little research on the subject and treatment is therefore based on expert~     knowledge rather than scientific research.~      The study objective is to identify the most effective and least stressful treatment of~     children with constipation for both families and the health care system.~      The following will be tested:~      Does treatment of constipation in children require specialized knowledge and extensive~     resources or can the treatment be simplified?~      The results from this study are expected to form the basis for a evidence based treatment of~     children with constipation.~   "
112535|NCT01583205|"~     The investigators propose to adapt and pilot test a behavioral intervention for recently~     diagnosed patients with Amyotrophic Lateral Sclerosis (ALS), and/or a family care partner.~     ALS fatal neurodegenerative disease, the diagnosis of which can have a devastating impact on~     patients and their families. Our eight session intervention is derived from Coping~     Effectiveness Training, a manualized intervention based on stress and coping theory. It is~     designed to strengthen coping skills and alleviate distress following diagnosis.~      Participants (patients and/or care partners) will be recruited from the Eleanor and Lou~     Gehrig MDA/ALS Research Center, Columbia University. The main outcomes are changes in~     distress level, depression and anxiety symptoms, and coping self-efficacy.~      Once the investigators gain preliminary experience with the manual, get some sense of~     feasibility and acceptance, and learn about patient and care partner reactions, the~     investigators will be better able to prepare a grant application seeking NIH support for the~     development of the intervention, with the eventual goal of a multisite randomized controlled~     trial (RCT).~   "
112536|NCT01583192|"~     The study will prospectively compare the efficacy and safety of chloride hexidine soluted in~     alcohol with povidine-jodine soluted in alcohol in forefoot surgery.~   "
112537|NCT01583179|"~     The patients included will be those who have already agreed to have a brachial plexus nerve~     block for surgery. A flip of the coin will decide who gets and additive called buprenorphine~     in their block or not. They will both contain the same amount and type of numbing medicine.~     The goal will be to see if the additive extends the life of the pain control portion of the~     ultrasound guided supraclavicular nerve block.~   "
112538|NCT01583166|"~     The purpose of this study is to determine if there is a difference in post-operative voiding~     function between subjects receiving local anesthetic and those receiving placebo at the time~     of mid-urethral sling placement. The secondary objective is to evaluate pain after the~     procedure in the two groups.~   "
112539|NCT01583153|"~     Total knee replacement (TKR) surgery is a common and highly effective treatment option for~     alleviating the pain and disability caused by chronic arthritis. The associated~     rehabilitation costs, however, impose a significant burden on the health system. In~     particular, inpatient rehabilitation - utilised by approximately 43% of private TKR~     recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000~     (AU) per inpatient episode.~      The overarching aim of this study is to establish whether inpatient rehabilitation is~     necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged~     directly home.~      The main hypothesis to be tested by the proposed study is that TKR recipients who receive~     inpatient rehabilitation in addition to participating in a home programme, compared to~     patients who participate in a home programme only, will achieve a superior level of~     mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.~      Secondary hypotheses to be tested relate to patient-reported knee pain and function,~     health-related quality of life, functional ambulation, and knee joint mobility.~      Superiority in these outcomes will be evident at six months after surgery.~   "
112540|NCT01583140|"~     In this study the investigators are specifically targeting Latina women because they are~     more likely to be inactive and, therefore, are at higher risk for developing chronic~     conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and~     cognitive interviews with Latinas in the Providence area, the investigators have modified~     our print-based intervention, already tested and proven to be effective in English-speaking~     communities, to be culturally and linguistically appropriate for the Latina community.~      The objective of Seamos Saludables is to determine whether this culturally tailored print~     intervention will produce greater increases in physical activity levels among Latina women~     than a program focused on general health topics. Participants are randomly assigned to one~     of two groups (exercise and general wellness) and attend 4 clinic visits to complete~     baseline and follow-up assessments.~      The investigators hypothesize that at the end of treatment, intervention participants will~     report significantly more minutes of at least moderate intensity physical activity per week~     than the wellness contact control participants.~   "
112541|NCT01583127|"~     To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions~     and Supports, which is a school-based prevention program aimed at reducing behavior problems~     in children.~   "
112542|NCT01583114|"~     This is a multicentre European double-blind,randomized and controlled trial with 2 parallel~     groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors~     (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated~     cardiomyopathy).~      Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a~     mutation (leading to a genetic form of heart failure) but have not yet developed DCM.~      Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to~     systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with~     autosomal dominant inheritance, and underlying genes and mutations are increasingly~     identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related~     penetrance (or delayed-onset), that means that the cardiac expression of the disease~     (echocardiographic abnormalities) is usually absent for a long period and progressively~     appears with advanced age, usually after 20 years of age~      Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical~     stage).~      Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge~     derived from basic research (genes identification in DCM) will be translated into clinical~     practice (early identification of subjects at high risk of developing heart failure through~     predictive genetic testing) with the development of new therapeutic management (early ACEi)~     that will help to decrease the morbidity and mortality associated with the disease. This~     will constitute a paradigm of the development of preventive medicine thanks to the~     development of genetics in the cardiovascular field.~      Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible~     for DCM and are at a preclinical stage of the disease. Total duration of treatment~     (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled~     (100 in each group) in 7 centres.~   "
112543|NCT01583101|"~     The investigators have developed a novel decision support system for implementing clinical~     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer~     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a~     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing~     electronic medical record systems. The result is a system that both delivers just-in-time~     patient-relevant guidelines to physicians during the clinical encounter, and accurately~     captures structured data from all who interact with it. Preliminary work with CHICA has~     demonstrated the feasibility of using the system to implement and evaluate clinical~     guidelines.~      However, analyses have shown that physicians ignore a fair number of prompts. The~     investigators would like to experiment with changes to the system to see if they can~     increase physicians' response rates. This could include highlighting prompts, reordering~     them, or flagging them in other ways. The main outcome of interest in the rate at which~     physicians answer prompts.~   "
112544|NCT01583088|"~     ALS is is characterized by a progressive degeneration of motor neurons, leading to~     progressive weakness of muscles, including respiratory muscles, the diaphragm. Although~     specific therapy is lacking, correct respiratory therapy improves quality of life and~     increases survival. Substituting the failing respiratory muscles by non invasive mechanical~     ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic~     nerve stimulation is a new treatment and has been the object of a preliminary international~     proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic~     nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is~     that phrenic stimulation induces diaphragm conditioning and can delay the need for~     mechanical ventilation in ALS patients. We will study, during 24 months, 2 groups of 37~     patients at the beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic~     nerve stimulation in one group and a sham stimulation in the other group. Although, all the~     patients will be implanted, thus, at the end of the study, all the patients will receive~     effective stimulation.~   "
112545|NCT01583075|"~     The single-ring ablation method aims for isolation of the posterior LA wall including the~     pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is~     unlikely.~      Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided~     single-ring ablation method as compared to standard RMN-guided circumferential PVA.~   "
112546|NCT01583062|"~     Facial fractures make up a significant proportion of injuries in trauma patients. Treatment~     of these fractures often results in standard surgical interventions. While up to the early~     1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its~     efficacy is well accepted today. Chole and his team could show that the administration of~     antibiotics one hour preoperatively and eight hours after the intervention reduces the~     incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there~     is still no consensus about the duration of the postoperative administration. In literature~     postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration~     of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with~     allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial~     resistance. In addition some authors assume that a prolonged administration of antibiotics~     might increase the risk of infectious complications via superinfection. On the other hand a~     short term or single shot administration might not be enough to prevent the onset of an~     postoperative infection. Up to date there is no standard to support the administration of~     antibiotics after surgical repair of a facial fracture.~      The purpose of this prospective, randomized double-blinded trial is to investigate the~     utility of antibiotics administered in the postoperative period after surgical revision of~     facial fractures.~      Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally~     effective as a long-term administration of 5 days in facial fractures.~   "
112547|NCT01583049|"~     Primary objective: This is a descriptive study and the primary objective is to determine the~     incidence of injection site and systemic adverse events after Triaxis administration as a~     5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children~   "
112548|NCT01583036|"~     An interaction study to assess the effect of the ezogabine/retigabine and the main~     metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers~   "
112549|NCT01583023|"~     The purpose of this study is to evaluate whether repetitive transcranial magnetic~     stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and~     Bupropion.~   "
112550|NCT01583010|"~     Needle tip visualization, although fundamental to the safety and efficacy of~     ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is~     most marked at steep insertion angles. Studies in patients with UGRA demonstrate that~     echogenic needle designs have the potential to offer improved visibility and accuracy.~      Our study pursues another approach. We use (for differentiation) echogenic nerve block~     needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization~     Technology®). We will compare UGRA with ANV® against standard UGRA without using this~     SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve~     blocks as part of their routine anesthetic management are included.~      This work represents the first randomized controlled double blinded clinical trial of ANV®~     in patients undergoing UGRA. We hypothesize, that we can decrease the time without needle~     visualization (Loss of needle time in percentage of procedure time) during in-line regional~     anaesthesia. Furthermore we will record quality of visibility, duration of procedure and~     insertion angle of the needle.~   "
112551|NCT01582997|"~     BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This~     study will be designed to assess safety, tolerability, single and repeat dose PK profile and~     preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive~     solid tumors using continuous daily dosing schedule.~   "
112552|NCT01582984|"~     A structured consent process, in combination with one or a number of the aforementioned~     modalities (nursing education, handout, video, etc), may reasonably be expected to improve~     surgical informed consent. The investigators hypothesized that overall patient~     knowledge/retention would be influenced by the type of consent process and that more~     intensive training and review would result in better patient retention and recall. The~     investigators further hypothesized that the knowledge retention would decline following the~     consent process and surgery, but in a stratified manner based on the nature of preoperative~     teaching.~   "
112553|NCT01582971|"~     The purpose of this project is to test foot reflexology delivered by a friend or family~     member in the home for women with breast cancer. The primary aims of the proposed study in a~     sample of women (post-attrition n=200) with breast cancer receiving chemotherapy and/or~     hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly~     reflexology sessions compared to an attention control group.~   "
112578|NCT01582646|"~     Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants~     (ADs) are recommended as the first line treatment. In a murine model, the investigators~     evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic~     receptor stimulation and that β-mimetics display the same effect. These data support the~     idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain~     treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain~     symptoms.~   "
112554|NCT01582958|"~     This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT)~     given to patients with moderate to severe chronic obstructive pulmonary disease (COPD)~     enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved~     respiratory pump function over and above that seen in sham and control groups. Specifically,~     we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial~     release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level;~     and (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key~     clinical readouts will include: spirometry, P100 (and index of diaphragm and inspiratory~     muscle efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure~     (MEP), as well as laser evaluation of chest wall excursion. Supplementing these objective~     parameters will be several more subjective clinical outcome measures: exercise tolerance~     (6-minute walk test), dyspnea (shortness of breath questionnaire), and quality of life~     questionnaire. Finally, an attempt will be made to correlate biochemical alterations that~     may shed light on the biological mechanism underlying the OMT procedures.~   "
112555|NCT01582945|"~     Ketamine infusion has been shown to have rapid antidepressant properties, however the~     possible use of ketamine in treatment-resistant depression as augmentation has not been~     investigated. The overall aim of this study is to assess the feasibility, safety and~     tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate~     antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in~     subjects with severe treatment-resistant depression (TRD).~      This is an open-label study (pilot).~   "
112556|NCT01582932|"~     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects~     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for~     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a~     multicenter study comparing calcipotriene foam, 0.005% with vehicle foam in pediatric~     subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or~     their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day~     on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and~     pharmacokinetics of calcipotriene will be evaluated.~   "
112557|NCT01582919|"~     It is now acknowledged that Alzheimer's disease is characterized by a long period of~     pathophysiological change. Developing new strategies to achieve diagnoses as early as~     possible has become a major goal for therapies aimed at slowing the progression of this~     disease. While diagnoses currently rely principally on clinical neuropsychology, the typical~     diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The~     goal of our project is to identify very early imaging markers for Alzheimer's disease among~     patients with no report of cognitive difficulties. In order to achieve this goal, we propose~     a longitudinal study in an elderly population cohort.~   "
112558|NCT01582906|"~     After treatment women surviving gynaecological cancer may experience lateeffects and~     longterm challenges specific to their disease and treatment resulting in functional deficits~     and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available~     research on best models of posttreatment rehabilitation support for women posttreatment for~     gynaecological cancer is limited. The primary objective of this study is to determine if~     there is any additional benefit, over usual rehabilitation care, of additional~     rehabilitation appointments to develop a survivorship care plan on cancer specific health~     related quality of life.~      Secondary objectives are to determine any additional benefit to general selfefficacy,~     generic health related quality of life or social and health economics for patients who have~     completed treatment for stage I or II gynaecological cancer. Also to explore the patient's~     perspectives of the intervention. The study will be open to patients attending the~     outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently~     completed treatment for Stage I or II gynaecological cancer. They will report that they have~     experienced a physical or psychosocial need resulting from the disease or its treatment; be~     aged over 18 years and be willing and able to articulate their needs. The study will last~     for six months for each participant. It will involve completing questionnaires and attending~     two extra rehabilitation appointments to develop a survivorship care plan at the hospital~     may also include attending for an interview about being involved in the study for those~     randomised to the intervention group~   "
112559|NCT01582893|"~     Chronic dialysis patients with end stage renal disease have an increased mortality rate as~     compared to the age matched healthy population. It is known that chronic inflammation~     contributes to the high incidence of cardiovascular events in chronic dialysis patients.~     Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be~     beneficial in the elimination of inflammatory mediators and may improve the inflammatory~     status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100~     will improve the inflammatory status of chronic dialysis patients.~   "
112560|NCT01582880|"~     The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet~     A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston~     KPro) in patients with higher risk for corneal melting (keratolysis).~   "
112561|NCT01582867|"~     The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration~     treatment.~   "
112562|NCT01582854|"~     The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in~     subjects with post stroke cognitive impairment (PSCI) during a six month treatment period~     compared to subjects administered placebo. Subjects received IV infusions whilst in~     hospital, and tablets once discharged. Subjects were followed up for a further six months~     after their treatment had been stopped to explore if the cognitive symptoms of the subjects~     treated with Actovegin showed sustained improvement. The trial also explored the possible~     prevention of dementia with Actovegin in patients who had suffered a recent ischaemic~     stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on~     Actovegin was collected.~   "
112563|NCT01582841|"~     The investigators research mobilizes the resources of an integrated health-delivery system~     with extensive electronic clinical data to implement and evaluate a new strategy to maximize~     screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.~   "
114147|NCT01562093|"~     In this study we will investigate the effect of intranasal corticosteroid therapy, which is~     known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.~   "
112566|NCT01582802|"~     Multiple births in the United States are rapidly increasing in large part due to assisted~     reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of~     all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia~     yet there are virtually no data on Fe status in women carrying multiples and current~     recommendations do not necessitate Fe screening among this high risk group. Maternal anemia~     is known to increase the risk of adverse birth outcomes including preterm birth and low~     birth weight. Moreover, the developing brain is increasingly recognized to be susceptible to~     Fe insufficiency in utero and growing data support that suboptimal Fe stores at birth are~     associated with long-term irreversible cognitive deficits in the offspring. To address these~     gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe~     status indicators and serum hepcidin across pregnancy in approximately 120 women carrying~     twins and triplets. Determinants of maternal anemia will be identified. Neonatal~     hematological measures will be assessed in cord blood from each neonate at birth for~     assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal~     anemia will be identified. Inflammatory markers will be measured in all blood samples and~     related to outcomes. Stable iron isotopes will be given to a subset of women to assess~     maternal Fe absorption and fetal Fe uptake.~   "
112567|NCT01582789|"~     The purpose of this study is to obtain objective and subjective clinical data to compare the~     performance of two soft contact lenses.~   "
112568|NCT01582776|"~     This study is to determine first the appropriate dose of lenalidomide to administer in~     combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma~     patients.~      In a second step, this study aims to determine the efficacy of this combination in 3~     separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma~     and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and~     previously untreated follicular lymphoma (cohorts 3 and 4).~   "
112569|NCT01582763|"~     International GBS Outcome Study (IGOS) is a study conducted by the members of the~     Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease~     course and outcome in Guillain-Barré syndrome (GBS).~      The IGOS aims to identify clinical and biological determinants and predictors of disease~     course and outcome in individual patients with Guillain-Barré syndrome, as early as possible~     after onset of disease.~   "
112570|NCT01582750|"~     The purpose of this study is to determine the role of endoscopic ultrasound measurement of~     the primary tumor maximum diameter changes in absolute / relative values in predicting the~     tumor regression after concurrent chemoradiotherapy for rectal cancer.~   "
112571|NCT01582737|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Xarelto for SPAF.~      The objective of this study is to assess safety and effectiveness of Xarelto using in real~     clinical practice.~      A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational~     period. An annual follow-up survey will be conducted for 5 years at the longest after~     standard observational period.~   "
112572|NCT01582724|"~     The aim of the study is to evaluate the effectiveness of additional self-care acupressure in~     women with menstrual pain compared to usual care alone.~   "
112573|NCT01582711|"~     The study is an open label, multicenter, randomized (three arms: DOT (standard control),~     SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients~     diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The~     primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly~     rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to~     self-administered therapy (SAT). The secondary objectives:~        -  To compare the treatment completion rates between participants randomized to SAT~          without reminders versus SAT with weekly SMS reminders~        -  To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among~          participants who complete treatment and those who discontinue therapy prior to~          completion.~        -  To determine the availability and acceptability of using SMS reminders among all~          patients consenting to participate in the study.~        -  To determine the toxicity and tolerability by comparing the rates of any drug-related~          grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both~          combined and individually)~        -  To compare the frequency, timing, and causes for failure to complete treatment between~          the DOT arm and the SAT arms~        -  To collect patient-specific cost data related to the 3 treatment arms~        -  To describe the pattern of antituberculosis drug resistance among Mycobacterium~          tuberculosis strains cultured from participants who develop active TB.~   "
112574|NCT01582698|"~     The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after~     the first booster TBE vaccination with FSME-IMMUN 0.5ml.~   "
112575|NCT01582685|"~     The investigators hypothesize that exercise in postmenopausal breast cancer survivors will~     result in an increase in the plasma concentrations of angiostatic factors and a decrease in~     the plasma concentrations of angiogenic factors. Exercise is expected to result in a~     circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer~     tumor, growth of microscopic residual disease after breast cancer resection, decreases rates~     of local-regional recurrence, decreases rates of distant recurrence, and increases survival.~   "
112576|NCT01582672|"~     This is a trial of AGS-003, which is being studied as a possible treatment for Advanced~     Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall~     survival (OS) benefit between subjects treated with AGS-003 in combination with standard~     treatment versus subjects treated with standard treatment alone.~   "
112602|NCT01582321|"~     Inflammation is a key initiating and damaging factor in many illnesses including infection,~     arthritis and cancer but also of particular relevance to this study in diseases of the heart~     and blood vessels (i.e. cardiovascular disease). Much evidence now exists demonstrating that~     male sex increases ones risk of cardiovascular disease. More recent evidence demonstrates~     that inflammatory responses in females appear to dampened in comparison to age matched~     males. Since inflammation is thought to be a key initiating phenomenon in many~     cardiovascular disease states the investigators will examine the differences in acute~     inflammatory responses between the sexes in healthy volunteers and the impact this has on~     the function of blood vessels.~   "
112579|NCT01582633|"~     This study will evaluate the immunological response and the safety profiles of seasonal,~     inactivated vaccine which contains in its composition the A/California/7/2009 H1N1~     pandemic influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via~     IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and~     control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects~     from 42 to 60 years old.~      Reduced doses into the skin will be delivered by an investigational intradermal model of a~     licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA~     manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and~     dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also~     rapid and simple and overcomes the difficulty and patient discomfort of the traditional~     Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin~     testing.~      Participants will be assessed for local and systemic adverse events by clinical observation~     immediately after injection and then upon return on day 21 after each injection. In~     addition, investigators will call participants by telephone on days 2 and 7 days to collect~     information local and systemic side effects.~      Serum will be collected on day 21 after each injection, and assayed for hemagglutination~     inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto~     de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant.~     Information about the adverse events would be collected on days 1, 3 and 7 after dose~     delivery. The investigators assessing adverse reactions will be blinded to the study arm to~     which each subject was allocated.~      The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each~     dose in accordance with international parameters which include: seroconversion or~     significant title increase (SCR), the frequencies by study arm of seroprotection defined as~     a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs)~     of post-vaccination sera.~   "
112580|NCT01582620|"~     The purpose is to study the clinical, technological and organizational impacts of a~     telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in~     Lofoten and Vesterålen. The stroke specialist in Bodø will examine the patient in~     cooperation with the doctor at the local hospital through video- and sound communication.~     Radiology images are transmitted using the RIS/PACS system.~      Telestroke consultations may be useful to assess whether the patient needs thrombolysis~     medication, and also whether there is a need for more advanced specialist neurological or~     neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit.~      The study design is a multi-method approach using before-and-after hospital information data~     as well as registration forms monitoring patient outcome and pathways. The research~     questions will be approached from medical, organisational and technological perspectives.~      A telestroke service in North Norway is expected to face other challenges than those~     reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of~     cases is low, clinicians have high turnover, technical support is not available 24/7 and~     severe weather conditions and long distances might add to the transport time.~      Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and~     proper treatment~      Secondary hypothesis: Telestroke leads to improved overall patient treatment~   "
112581|NCT01582607|"~     The purpose of the investigators study is to compare the clinical effects and side-effects~     of these three local anaesthetics as sole agents or with the supplementation with fentanyl~     for c-section, especially when administered in doses achieving approximately an ED 50.~   "
112582|NCT01582594|"~     To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test~     using known anti-HCV seropositive and seronegative specimens.~      Registration for license application~   "
112583|NCT01582581|"~     The purpose of this study is to evaluate a computer-guided, telephone-based therapy for~     adolescent depression, delivered in a pediatric primary setting in the community.~   "
112584|NCT01582568|"~     The primary objective of this study is to assess perianal and perirectal fistula healing~     (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI~     (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no~     fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab~     (Cimzia).~   "
112585|NCT01582555|"~     Nasal irrigation techniques have been used for many years and been shown to improve symptoms~     of rhinosinusitis. Although there is a wealth of literature available, establishing~     treatment protocols can be difficult because of the great variability in recommended~     composition (seawater or hypertonic or isotonic saline with or without additives) and~     irrigation technique (variations in pressure and volume). Nasal irrigation is also used in~     many centers as part of postoperative treatment protocols and in particular has been~     recommended following endoscopic sinus surgery (ESS). Nasal crusting and thick nasal~     discharge have a negative impact on these patients quality of life (QOL). At the time of our~     study, there are no studies comparing irrigation with mucolysis with saline irrigation~     following ESS. The investigators aimed to assess whether mucolysis is effective at improving~     patients QOL and reducing postoperative signs as assessed endoscopically.~   "
112586|NCT01582542|"~     The purpose of this study is to prospectively assess whether Desmopressin, given for a~     period of month to patients after radical cystectomy with orthotopic bladder reconstruction,~     improves and lowers the rate of nocturnal enuresis.~   "
112587|NCT01582529|"~     The purpose of this study is to learn about the relationship between family factors and~     developmental and psychosocial outcomes in children with congenital heart disease at 6 years~     of age. A secondary purpose is to learn more about psychosocial outcomes in children with~     congenital heart disease and their families over time.~      About 250 mothers and fathers at 15 medical centers will take part in this study; 35 will be~     from Children's Hospital of Wisconsin.~   "
112603|NCT01582308|"~     A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV~     (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin~     and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice~     daily dosing in participants with T2DM. The primary hypothesis is that following multiple~     daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin~     will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg~     saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM.~     Each participant will receive all 5 treatments in randomized order. There will be a washout~     interval of at least 10 days between the last dose of study drug in one period and the first~     dose of study drug in the following period.~   "
112667|NCT01581476|"~     The purpose of this study is to determine whether use of blood pressure lowering drugs,~     Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs~     (statins) may have a place in the treatment of adolescents with diabetes and can help reduce~     serious long-term health problems in this population.~   "
116163|NCT01535651|"~     The investigators are exploring the use of short message service (text) messaging by cell~     phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy~     prevention program.~   "
112588|NCT01582516|"~     In the Netherlands a 2 center investigator-driven phase I/II clinical trial is initiated in~     June 2010 testing the oncolytic adenovirus Delta24-RGD to treat glioblastoma patients. The~     virus is administrated using convection-enhanced delivery by 4 catheters as delivery~     technique, targeting solid tumor as well as infiltrated tumor cells within the peri-tumoral~     brain. Patients will be enrolled in cohorts of 3 per dose-level. The dose levels to be~     explored are: 10^7, 10^8, 10^9, 10^10, 3*10^10 and 10^11 viral particles (vp). Once the MTD~     has been determined, or the study has reached the highest dose cohort, a further 6 or 9~     patients will be enrolled at the MTD and evaluated for safety and preliminary signs of~     efficacy, such that in total at least 12 patients have received the MTD.~      The primary objective is to determine the safety and tolerability of Delta-24-RGD~     administered by CED to the tumor and the surrounding infiltrated brain in patients with~     recurrent GBM. Secondary objectives are to determine the Progression Free Survival (PFS),~     Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable~     for surgical resection and treated at the MTD.~      Cerebrospinal fluid as well as brain interstitial fluid by microdialysis next to the~     routinely collected samples of blood at various timepoints before, during and after virus~     infusion. Various neurodegenerative biomarkers as well as markers of immune response will be~     assessed in these samples.~      Furthermore extensive sampling and PCR analyses will be performed to evaluate distribution~     and shedding of the virus.~   "
112589|NCT01582503|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain~     inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a~     second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous~     repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will~     continue their usual asthma medication throughout the study. Anticipated time on study~     treatment is 36 weeks, with a 48-week follow-up.~   "
112590|NCT01582490|"~     This is a Phase 4, prospective, open-label, non-randomized, sequential study with two~     treatment groups differing only in the technique used for EXPAREL administration~     (instillation or infiltration).~   "
112591|NCT01582477|"~     The purpose of the study is to assess the safety and efficacy of EXPAREL when administered~     via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical~     analgesia in men undergoing robot-assisted laparoscopic prostatectomy.~   "
112592|NCT01582464|"~     The goal of this phase of the project is to identify the elements of the Theory of Planned~     Behavior (TPB) that should be targeted to provide the most influence on older adults'~     behavior (or other stakeholders) to purchase and wear protective headwear. The investigators~     also intend to determine the format of communication (social marketing/academic detailing)~     that is most influential for different key stakeholder groups. The TPB has been useful in~     understanding behavior change related to exercise and adaptive equipment use (such as grab~     bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social~     norms and perceived behavioral control inform the development of intention that leads to~     behavior change.~   "
112593|NCT01582451|"~     The purpose of this study is to compare LY2605541 and insulin glargine using the following~     measures after participants have been treated for 26 weeks:~        -  Change in participants' overall blood sugar control~        -  The number of night time low blood sugar episodes~        -  The number of participants that reach blood sugar targets without low blood sugar~          episodes at night~        -  The total number of low blood sugar episodes reported~   "
112594|NCT01582438|"~     The purpose of this study is to provide sildenafil therapy to subjects who have completed~     the A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and~     are judged by the Investigator to derive clinical benefit from continued treatment with~     sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary~     Arterial Hypertension (PAH) until the subject continues to derive benefits from the~     treatment. The treating physicians (and the sponsor) will be responsible for reporting~     serious adverse events.~   "
112595|NCT01582425|"~     The primary purpose of this study is to assess the effect of multiple doses of isavuconazole~     on the pharmacokinetics (PK) of methadone after single dose administration. The secondary~     purpose is to assess the safety and tolerability of isavuconazole alone and in combination~     with methadone.~   "
112596|NCT01582412|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of digoxin in healthy adult subjects.~   "
112597|NCT01582399|"~     The objective of this study is to assess levels of ASKP1240 in the blood after a single dose~     given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how~     the drug behaves inside the body and how it is eliminated from the body by looking at the~     pharmacokinetics of ASP1240.~      In addition, the study will determine the effects of ASKP1240 on the body by looking at its~     pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as~     SC injection.~   "
112598|NCT01582373|"~     The current pilot study aims to assess the feasibility and preliminary efficacy of a novel,~     12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.~   "
112599|NCT01582360|"~     The main purpose of the study is to examine if changes in pharmacokinetics of important~     antiinfectives in Critically Ill patients in need of continuous renal replacement therapy~     (CRRT), causes inadequate concentrations in plasma.~      The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of~     filter, filter lifetime etc.~      Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased~     in critically ill patients receiving CRRT. Inadequate plasma concentrations of~     antiinfectives may contribute to increased mortality in this group.~   "
112600|NCT01582347|"~     This study is designed to determine if opioid dependent subjects who are already receiving~     Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will~     continue their pre-study prescribed dosage of Subutex and/or Suboxone~   "
112601|NCT01582334|"~     This is an Argentinian, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®~     via easypod™.~   "
112604|NCT01582295|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means the FDA has not approved the drug for your type of cancer.~      Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug~     cabozantinib works by inhibiting several different proteins which are believed to be~     involved in multiple myeloma growth, its ability to spread, and its ability to form new~     blood vessels. This drug has been used in other research studies and information from those~     other research studies suggests that this drug may help to slow or stop disease growth to~     bones and prevent cancer growth.~      In this research study, we are looking to see how effective cabozantanib is in slowing or~     stopping disease growth to the bones as well as preventing your cancer from worsening. We~     are also looking for the highest dose of cabozantinib that can be given safely to patients~     who have multiple myeloma with bone disease.~   "
112605|NCT01582282|"~     A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2~     phases; 1) an 8-week lead-in period during which patients followed a diet judged to be~     within the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the~     beginning of which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo,~     3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a~     total of 13.6 g/day (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the~     fiber-free placebo BID, just prior to breakfast and dinner.~      Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6,~     -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where~     a blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum~     glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done~     at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician~     at each visit and discussed with the patient to ensure compliance with the recommended diet~     and the patients' body weights were recorded~   "
112606|NCT01582269|"~     The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299~     plus lomustine therapy or lomustine plus placebo can help participants with brain cancer~   "
112607|NCT01582256|"~     The study aims to investigate whether neuropsychological function (particularly cognitive~     flexibility and executive function), functional (assessed by resting functional MRI, rfMRI)~     and structural connectivity (assessed by DSI), and electrophysiological function (assessed~     by event-related potential [ERP]: mismatch negativity, MMN and P50) can be effective~     cognitive endophenotypes (biomarkers) for Autism spectrum disorders (ASD).~   "
112608|NCT01582243|"~     This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2~     diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment~   "
112609|NCT01582230|"~     The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid~     add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus~     inadequately controlled on insulin with or without metformin treatment.~   "
112610|NCT01582217|"~     The purpose of this study is to assess the the 1-year rates of ischemic and bleeding~     complications in patients whose dual antiplatelet therapy regimen post-PCI has been~     determined with the use of a clinical algorithm that includes both clinical risks and~     platelet reactivity while on chronic clopidogrel therapy.~   "
112611|NCT01582204|"~     Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors.~     Sometimes, even when a drug is working, it can take several months before the effects are~     seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called~     124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular~     CT scan.~      Research has shown that certain proteins in the blood, called antibodies, can attach~     themselves to cancer cells without binding to normal cells. In this study, an antibody is~     used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive~     isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body,~     124I shows up on the PET scan.~   "
112612|NCT01582191|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of vandetanib and everolimus that can be given to patients with advanced cancer.~     The effects of the study drugs at different dose levels and the safety of the study drugs~     will also be studied.~      Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth.~     This may stop or slow the growth or spread of cancer cells.~   "
112613|NCT01582178|"~     Water immersion insertion has been documented to decrease procedure-related discomfort~     during colonoscopy. There was used warm water infusion for colonoscope insertion in most of~     the water immersion colonoscopy trials.~      The investigators have been using room temperature water (20-24°C) for water immersion and~     the investigators did not notice any drawback of it. In our opinion, it is simpler and~     cheaper option for water immersion colonoscopy and proof of its efficacy and safety could~     support the use of water immersion technique in routine practice.~      The primary endpoint is cecal intubation time and the investigators suppose that the use of~     warm water infusion does not shorten it significantly. Patient comfort during colonoscope~     insertion, water consumption, length of the scope while reaching the cecum, need for~     external compression, need for positioning of the patient and endoscopist´s difficulty with~     colonoscopy will be also assessed.~   "
112614|NCT01582165|"~     Female patients presenting with persistent chest pain despite no obstructive coronary artery~     disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as~     20% of women with chest pain and minimal angiographic CAD have evidence of myocardial~     ischemia, suggesting impaired coronary microcirculation. The index of microvascular~     resistance (IMR) is a method for indirectly investigating microvascular function in the~     cardiac catheterization laboratory.~      66 female patients, age 30-70 years, with chest pain and normal or near normal coronary~     angiograms will be included. After coronary physiologic evaluation, patients will be~     randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for~     altogether 6 months.~      The investigators hypothesize that:~        1. A substantial number of women with chest pain and normal or minimal pathology on~          angiograms have microvascular dysfunction defined by a raised IMR.~        2. Statins, based on its pleiotropic action will improve endothelial function and thereby~          IMR.~   "
112615|NCT01582152|"~     The goal of Part I of this clinical research study is to find the highest tolerable dose of~     TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part~     II is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma~     better than when bevacizumab is given alone. The safety of the drug combination will also be~     studied.~      TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a~     protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may~     be able to cause the cancer cells to shrink or stop growing.~      Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the~     growth of blood vessels.~   "
112616|NCT01582139|"~     The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell~     Phone + Closed Loop Control) can successfully control blood sugar in people with type 1~     diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be~     studying to see if information about heart rate can help the AP Platform reduce hypoglycemia~     related to exercise.~   "
112617|NCT01582126|"~     People with multiple sclerosis (MS) often have affected balance capacity and an increased~     risk for falls. A risk factor for falls are activities requiring dual attention. Another~     factor leading to reduced balance capacity is trunk stability, and decreased trunk stability~     has been seen in people with MS compared to healthy controls. Earlier studies using core~     stability exercises have shown positive effects on balance, compared to no training. In~     Sweden, physical therapy for people with MS has often included group training. However,~     evidence for this intervention is scarce. The aim of this study is therefore to investigate~     balance training in group. The balance training includes core stability exercises and dual~     attention activities. A multi-centre study is planned with a waiting-list design.~     Participants are randomised to either exercise group with early start or with late start.~     The group balance training includes training 60 minutes 2 times per week for 7 weeks.~   "
112618|NCT01582113|"~     To determine the functional effects of Citicoline, a natural supplement, when administered~     for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The~     investigators hypothesize that citicoline will provide cognitive benefits to this population~     after 28 days of supplementation.~   "
112619|NCT01582100|"~     Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently~     encountered in the health care setting. It affects roughly 40% of Americans monthly and 10%~     weekly. Of those with GERD, there exists a cohort that experience nausea with or without~     vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment~     options are limited and these symptoms may substantially alter their quality of life. New~     and novel therapies emerging include neuromodulation devices that may affect the central~     pathways leading to these symptoms. Of these, the Reletex band has been tested and proven~     efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy,~     and surgery, in addition to standard anti-nausea medications. The investigators propose that~     through a similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce~     GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of~     lives in this patient population.~   "
112620|NCT01582087|"~     The purpose of this study is to understand mechanisms associated with the development of~     coma during hepatic failure. As of today, those mechanisms are not understood and it is~     difficult to intervene and prevent coma development which is often associated with~     mortality. Understanding the mechanism involved, may allow us to prevent coma and develop~     new therapies to treat this disease.~   "
112621|NCT01582074|"~     Background:~      - Studies have shown that changes in breast density (the amount of white area on a woman's~     mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way~     to measure breast density repeatedly over time. Researchers want to test whether ultrasound~     tomography scans can show changes in breast density. To examine these changes, healthy~     volunteers with no history of breast cancer and women who are taking tamoxifen will have~     ultrasound tomography scans.~      Objectives:~      - To test whether ultrasound tomography scans can show changes in breast density related to~     tamoxifen exposure.~      Eligibility:~      - Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy~     volunteers who have never had breast cancer.~      Design:~        -  All participants will have a screening visit. Healthy volunteers will have one~          additional study visit; women taking tamoxifen will have three additional study visits.~        -  All participants will be screened with a physical exam and medical history. They will~          also give blood and saliva samples. This visit will also include an initial ultrasound~          tomography breast scan.~        -  For the healthy volunteers:~        -  At the study visit (12 months after the screening visit), participants will have a~          short interview and be weighed. They will also have an ultrasound tomography breast~          scan and provide a blood sample.~        -  For the women taking tamoxifen:~        -  At the second and third visits (1 to 3 months and 3 to 6 months after starting~          tamoxifen), participants will have a short interview. They will also be weighed and~          have an ultrasound tomography breast scan.~        -  At the fourth visit (12 months after starting tamoxifen), participants will have a~          short interview, weight measurement, and the ultrasound tomography breast scan, and~          will also provide a blood sample.~        -  All participants may be followed for up to 5 years after their final study visit.~   "
112622|NCT01582061|"~     This study will document the safety and efficacy of pasireotide s.c. in patients with~     Cushing's disease.~   "
112623|NCT01582048|"~     Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus,~     mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a~     reduced intensity conditioning regimen with fludarabine/treosulfan~   "
112624|NCT01582035|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug~     is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055~     given in combination with telaprevir in HCV infected patients. TMC647055 is being~     investigated for the treatment of hepatitis C infection. Telaprevir has recently been~     approved in the USA and in Europe for the treatment of chronic hepatitis C infected~     patients.~   "
112625|NCT01582022|"~     Research Methodology:~      It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual~     study in which one tonsillar fossa will be the tested side, and the other fossa will be the~     control. And the tested side will be packed with bupivacaine for five minutes. In the other~     hand, the controlled side will be packed for five minutes with gauze soaked in normal~     saline. The selection of the tested side and controlled side will be randomized based on the~     last digit in the medical record number (i.e. if the last digit is even then the tested side~     is the right and if the last digit is odd then the tested side is the left). Pain evaluation~     will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours~     post-op.~   "
112626|NCT01582009|"~     RATIONALE: Panobinostat and everolimus may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth or by blocking blood flow to the tumor.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     panobinostat together with everolimus and to see how well they work in treating patients~     with metastatic or unresectable renal cell cancer that does not respond to treatment with~     sunitinib malate or sorafenib tosylate~   "
112627|NCT01581996|"~     Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are~     very common complications of people with advanced chronic kidney disease (i.e., stage 5~     CKD), including chronic dialysis patients, and are associated with severe morbidity and~     increased mortality. Despite attempts to control serum phosphorus with dietary phosphorus~     restriction and the use of medicines that bind phosphorus in the gastrointestinal tract so~     that the phosphorus cannot be absorbed into the body( also called phosphate binders),~     chronic dialysis patients frequently remain hyperphosphatemic, particularly at the time when~     they commence each of their regular dialysis treatments.~      Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal~     phosphate binder that appears to have the advantages of being safe, well tolerated and~     effective at binding phosphate. There are limited data on the magnitude of binding of~     phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney~     disease.~      The specific aims for this proposal are as follows:~        1. To quantify, under precisely controlled metabolic balance conditions, the increase in~          fecal excretion of dietary phosphorus that occurs when patients undergoing chronic~          peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).~        2. To examine a dose response relationship between Fosrenol treatment and fecal phosphorus~          excretion. The investigators will examine in CPD patients ingesting a constant~          phosphorus intake, how much additional phosphorus is excreted in the feces at three~          different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.~        3. To examine how increased fecal phosphorus losses and more negative phosphorus balance~          caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of~          phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23,~          25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and~          fetuin-A.~        4. To assess whether there is any effect of Fosrenol and increased intestinal phosphate~          binding on protein-nitrogen balance.~   "
112628|NCT01581983|"~     The purpose of this study is to assess feasibility of an internet and individual format of~     mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression~     symptoms~   "
112629|NCT01581970|"~     This is a feasibility study to assess the effectiveness of cetuximab when administered with~     low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and~     neck who have progressed on first line chemotherapy other than a cetuximab containing~     regimen will be treated with standard of care weekly cetuximab and twice daily low dose oral~     cyclophosphamide for 12 weeks.~   "
112630|NCT01581957|"~     Specifically designed enteral formulations may improve the gastrointestinal tolerance during~     early enteral nutrition in the critically ill patient.~      This pilot trial will permit testing the design of the full-scale study providing valuable~     data on the expected effect of the formulation, the variability, thus helping to better~     estimate the required sample size.~   "
112631|NCT01581944|"~     Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids~     are benign growth in the womb or uterus and in order to preserve the fertility of women~     they, require an operation called myomectomy or shelling out of the fibroid. This procedure~     can be associated with large blood loss.~      In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to~     the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in~     current gynaecological practice to treat women with heavy periods.~      In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin~     agonist prior to their operation and no treatment. The intraoperative blood loss was~     measured. The study hypothesis: To determine whether administration of gonadotropin~     releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.~   "
112632|NCT01581931|"~     To establish bioequivalence (BE) under fed conditions between metformin in~     linagliptin/metformin fixed dose combination tablet and metformin reference product~     administered in free combination togther with linagliptin~   "
112633|NCT01581918|"~     Nausea and vomiting are common problems for cancer patients. Half of them will experience~     these symptoms during the course of their disease, either because of the cancer itself or~     because of their treatment1. They are ranked by patients as two of the worst adverse effects~     of cancer chemotherapy and cause a negative impact on patient's functional, emotional,~     social and nutritional status and quality of life2,3.~      Nowadays, a wide variety of antiemetic agents are available for the prevention and treatment~     of CINV. In this scenario, three classes play a critical role: Selective 5-HT3-receptor~     antagonists - approved for clinical practice in early 1990s, revolutionized the management~     of CINV representing the most effective agents in the treatment of acute emesis -,~     Corticosteroids - with unknown mechanism of action, effective when administered as single~     agents in patients receiving chemotherapy of low emetic potential but are most beneficial~     when used in combination with other antiemetic agents, potentiating their anti-emetic~     efficacy in both acute and delayed symptoms - and neurokinin 1 receptor antagonist - also~     effective against both acute and delayed emesis, but restricted utility in daily clinical~     practice because of its high cost.~   "
112634|NCT01581905|"~     Approximately 600,000 women undergo hysterectomy each year in the United States, of which~     12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine~     leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total~     laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven~     that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter~     hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has~     also shown the complication rates for laparoscopic cases are similar to open procedures in~     the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and~     Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an~     alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not~     indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages~     of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter~     hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the~     recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies~     are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques~     are the technical obstacles of performing minimally invasive hysterectomies. Robotic~     technology has emerged as a means to decrease the learning curve and increase the~     availability of minimally invasive surgery to patients. A current review of the literature~     reveals no randomized trials evaluating the efficacy of conventional laparoscopic~     hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to~     address this void.~      The primary objective of this study is to determine whether Robot-Assisted Laparoscopic~     Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to~     operative time, blood loss, and hospital stay. The investigator's secondary objective was to~     assess the cost, morbidity, and mortality of each procedure.~   "
112635|NCT01581892|"~     The aim of the study is to determine the safety and feasibility of autologous mononuclear~     stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.~   "
112636|NCT01581879|"~     The objective of this study is to compare the rate and extent of absorption of ziprasidone~     20 mg capsules versus Geodon 20 mg capsules under fed conditions.~   "
112637|NCT01581866|"~     The objective of this study is to compare the rate and extent of absorption of ziprasidone~     20 mg capsules versus Geodon 20 mg capsules under fasting conditions.~   "
112638|NCT01581853|"~     Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while~     Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago.~     The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200~     mg monotherapy once a day.~   "
112639|NCT01581840|"~     Treatment is based on radiochemotherapy for locally advanced tumours. The objective of~     treatment is to provide a cure without resorting to abdominoperineal amputation, while~     preserving sphincter function.~      The prognosis is mainly related to tumour size and lymph node invasion. The large majority~     of patients do not show any spread remote from the tumour at the time of diagnosis (2).~      Recurrences are mainly of a local/regional nature and require abdominoperineal amputation.~     This type of intervention is not always possible or complete, which then gives rise to the~     particularly distressing risk of local progression, with survival at 3 years of~     approximately 30% (3).~      It is therefore very important to achieve a complete and permanent tumour response from~     initial treatment with radiochemotherapy.~      Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in~     ENT cancer was able to increase recurrence-free survival and overall survival in these~     patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR~     antibodies in epidermoid cancer of the anus.~   "
112640|NCT01581827|"~     Heart failure (when the heart does not pump as well as it used to) is a medical condition~     which reduces the quality of life for the sufferers. Approximately 10% of people in western~     societies aged over 75 develop heart failure. There has been a shift towards prevention of~     this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal~     proBNP) will prove to be useful indicators of those at greatest risk. The current study~     therefore plans to follow up the 3500 participants at risk of heart failure from the~     original SCREEN-HF study.~      Participants who are willing to participate will be contacted annually. They will undergo a~     short physical exam, will be asked to complete a Quality of Life questionnaire and will have~     a blood sample taken. At the end of the study participants will also have an ECG and an~     echocardiogram.~   "
112641|NCT01581814|"~     To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin~     alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic~     PCOS patients~   "
112642|NCT01581801|"~     Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2~     obesity associated with complications. Among the bariatric surgical procedures, roux-en-y~     gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in~     the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before~     performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were~     super-obese, has recently emerged as a new restrictive bariatric procedure.~      Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although~     it seems to occur also after SG, in about 3% of the cases. However, until now no prospective~     studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies~     have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of~     hypoglycemic episodes.~      The primary aim of the present study is to conduct a 1-year randomized trial to compare the~     incidence of hypoglycemia after RYGB or SG.~   "
112643|NCT01581788|"~     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER~     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in~     healthy, adult, human subjects, under fed conditions and to monitor adverse events and~     ensure the safety of subjects.~   "
112644|NCT01581775|"~     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER~     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in~     healthy, adult, human subjects, under fasting conditions and to monitor adverse events and~     ensure the safety of subjects.~   "
112645|NCT01581762|"~     Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation~     tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with~     accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored~     to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles~     are similar. It has been suggested that although thinner needles provide less cellular~     material than do larger needles, the specimens from the former are less contaminated by~     blood, and thus easier to interpret. In addition, thinner needles may be easier to use~     because of greater flexibility, particularly for locations requiring important scope~     bending. As a result, a new 22G FNA needle has been designed in order to improve the~     tissue-sampling rate (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the~     tip of the new needle with promotes collection of core sample by shearing material from~     target lesion during retrograde movement of the needle in the lesion. The feasibility and~     safety of this newly design EUS-FNA needle have been demonstrated in a recent multicenter,~     pooled, cohort study using the 19G version. Successful puncture was technically feasible in~     98.2% of cases and the overall accuracy of 92.9%. There were no complications related to the~     technique.~      The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy~     rate of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.~   "
112646|NCT01581749|"~     The primary safety purpose of this study is to estimate the rates of immediate and long-term~     high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years~     after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate~     cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free~     survival rates with TrueBeam to 5 year biochemical diseases free survival rates with~     dose-escalated external beam radiation therapy.~   "
112647|NCT01581736|"~     This protocol is being conducted to determine the mechanisms responsible for insulin~     resistance, obesity and type 2 diabetes.~   "
112648|NCT01581723|"~     Bladder cancer is a common urological malignant disease. Patients with bladder cancer will~     first be managed with transurethral resection (TUR) of bladder tumor. For many years,~     monopolar transurethral resection of bladder tumor (TURP) has been the gold standard for~     treatment. However, complications including bleeding, bladder perforation and inadequate~     sampling of deep tumor biopsy remain the major concerns. Recently published papers suggested~     that the newer bipolar TUR technology has similar surgical outcomes but less complications~     comparing with monopolar TUR. In this study, investigators will investigate the benefit of~     new technology as compared with conventional monopolar resection on tumor clearance,~     complication and recurrence rates.~   "
112688|NCT01581190|"~     This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate~     drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress,~     and innate immune function using traditional and metabolomics-based profiling.~   "
112650|NCT01581697|"~     Atherosclerosis is the leading cause of death and disability in adults. However,~     investigations suggest that the basic pathology of heart disease as more severe myocardial~     infarction which usually reach mainly middle-aged or above, starts from childhood.~     Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults~     and children, is associated with early deposition of lipids in the aorta and coronary~     arteries.~      Among other recommendations for prevention and treatment of heart disease and risk factors,~     is the recommendation to encourage the intake of soluble fiber. The oats, a major source of~     soluble fiber, has been recognized as a potential component of the diet to lower blood~     cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble~     fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted~     that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the~     recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim~     for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per~     serving.~      The objective of this project will be compared by randomized clinical trial, the impact of~     intake of oats, for 8 weeks in the lipid profile of children and adolescents with~     dyslipidemia.~      Will be included in the study 120 volunteers aged between 5 and 16 years who are in~     nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2~     groups, with a control group and another intervention will receive 3 tablespoons of soup~     filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch~     and dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of~     treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the~     beginning and end of the study. To compare the groups are used Student's t and squared chi.~     The alpha of 0.05 is considered critical. The program will be used Statistical Package for~     the Social Sciences (SPSS) version 15.0.~      It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living~     habits and healthy alternatives to prevent these risk factors should be done since~     childhood, especially in children who already have cholesterol levels of change.~   "
112651|NCT01581684|"~     The primary objective of the current study is to investigate the safety, tolerability and~     pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of~     single rising doses.~      The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19~     (Cytochrome P450) genotyped extensive metabolisers (EM).~      Another objective is to compare the safety and pharmacokinetic profiles between two~     different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor~     metabolisers (PM)~   "
112652|NCT01581671|"~     The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT)~     testing as another way of predicting potential coronary artery blockages in the heart.~   "
112653|NCT01581658|"~     The objective of this study is to assess the effect of the different degrees of renal~     impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral~     administration of high dose BI10773 as a single dose in Japanese patients with type 2~     diabetes mellitus.~   "
112654|NCT01581645|"~     Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients~     with Parkinson's disease and Parkinsonism.~   "
112655|NCT01581632|"~     The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an~     integral role in early atherosclerosis, and contributes to the mechanism of coronary~     endothelial dysfunction and to the structural and mechanical properties that characterize~     plaque vulnerability. Thus, our study will characterize prospectively the correlation~     between the functional and structural vascular wall properties, and the activity of the~     Lp-PLA2 pathway.~   "
112656|NCT01581619|"~     Standard therapy for patients with early stage breast cancer consists of surgery to remove~     the cancer followed by radiation therapy. One question regarding radiation therapy for early~     stage breast cancer is whether the entire breast needs to be radiated or only a more limited~     area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the~     whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area~     of the breast where the cancer was removed (called the tumor bed).~      The investigators hope the option of PBI will reduce side effects from radiation therapy and~     shorten the radiation treatment process when compared to WBI, since only part of the breast~     is being treated. The investigators also hope that this will make such treatment more~     convenient for breast cancer patients.~      The purpose of the study is to evaluate the the safety of external-beam PBI in selected~     early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The~     investigators will also evaluate the local control and the cosmetic results.~   "
112657|NCT01581606|"~     Hypothesis:~      The use of teleophthalmology for patient screening will result in more rapid patient access~     for treatment. The use of teleophthalmology to monitor patients with wet AMD post-treatment~     will result in maintenance of good visual outcomes combined with a reduction in patient~     travel and improved patients satisfaction in a cost effective manner.~      Objectives :~      The Evaluation of Teleophthalmology in AMD project objectives are as follows:~        1. To evaluate the efficacy of teleophthalmology in screening patients referred to retina~          specialists for suspected wet AMD.~        2. To compare the time to treatment/retreatment with this program with that of patient's~          entering the system and being followed conventionally to determine the efficacy of~          teleophthalmology to provide rapid entry/re-entry into treatment programs.~        3. To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post~          therapy.~        4. To determine the compliance rate for monitoring wet AMD during follow-up utilizing~          teleophthalmology.~        5. To evaluate the cost effectiveness of teleophthalmology in screening/monitoring wet AMD~          patients including direct costs to the OHIP system and indirect costs to the~          patient/caregiver.~        6. To assess patient satisfaction with teleophthalmology versus standard clinical care in~          the monitoring of post-treatment wet AMD.~        7. To evaluate teleophthalmology as a tool for communication between community based~          Optometrists /Ophthalmologists and Retina Specialists.~   "
112658|NCT01581593|"~     The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin~     solution) is effective in treating Primary Immunodeficiency (PID).~   "
112689|NCT01581177|"~     The main objective of this study is to evaluate the efficacy, dose-ranging and initial~     safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to~     180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose~     inhaler (MDI) Active Control.~      This study will be conducted in male and female adult patients who have mild-to-moderate~     persistent asthma for at least 6 months, but are otherwise generally healthy.~   "
112690|NCT01581164|"~     The purpose of this research study is to perform a serial analysis of immune function using~     blood cells and sera obtained from patients after vaccination following hematopoietic stem~     cell transplantation (HSCT). The focus of this study will be to characterize several immune~     parameters during the clinical course of HSCT and correlate these findings with the effect~     of vaccination.~   "
112659|NCT01581580|"~     Background:~      - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like~     Parkinson's disease, that do not respond well to other treatments. DBS uses a~     battery-powered device called a neurostimulator (like a pacemaker) that is placed under the~     skin in the chest. It is used to stimulate the areas of the brain that affect movement.~     Stimulating these areas helps to block the nerve signals that cause abnormal movements.~     Researchers also want to record the brain function of people with movement disorders during~     the surgery.~      Objectives:~        -  To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.~        -  To obtain information on brain and nerve cell function during DBS surgery.~      Eligibility:~      - People at least 18 years of age who have movement disorders, like Parkinson's disease,~     essential tremor, and dystonia.~      Design:~        -  Researchers will screen patients with physical and neurological exams to decide whether~          they can have the surgery. Patients will also have a medical history, blood tests,~          imaging studies, and other tests. Before the surgery, participants will practice~          movement and memory tests.~        -  During surgery, the stimulator will be placed to provide the right amount of~          stimulation for the brain. Patients will perform the movement and memory tests that~          they practiced earlier.~        -  After surgery, participants will recover in the hospital. They will have a followup~          visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be~          programmed and adjusted over weeks to months to find the best settings.~        -  Participants will return for followup visits at 1, 2, and 3 months after surgery.~          Researchers will test their movement, memory, and general quality of life. Each visit~          will last about 2 hours.~   "
112660|NCT01581567|"~     Background:~      - Information and samples collected from participants in medical research studies can be~     useful even after the original study is complete. Researchers can use the information and~     samples to learn more about multiple sclerosis or other immune system disorders. They can~     also be used for research into other disorders. Researchers would like to get permission to~     use samples collected from older studies to launch new lines of research.~      Objectives:~      - To look at information and samples from earlier National Institutes of Health~     Neuroimmunology Branch studies.~      Eligibility:~      - People who provided samples and medical information for earlier studies.~      Design:~        -  Researchers will contact people who took part in earlier studies. Researchers will ask~          if they can study previously collected data and samples.~        -  Data and samples may include physical exam data and psychological test results. Imaging~          study results are included. Preserved samples of body fluids and tissues may be~          studied. These include blood and urine samples.~        -  No new treatment will be provided as part of this research study.~   "
112661|NCT01581554|"~     Background:~      - Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and~     cancer of the liver. There is no cure for the infection, but several drugs have been~     approved to treat it. These drugs can keep the virus levels low. They seem to be safe for~     short-term use. But the drugs have not yet been approved for long-term use because some of~     them can have serious side effects. However, stopping treatment too soon can make the~     infection worse and may lead to more serious forms of liver disease. Researchers have not~     been able to determine a when to stop treatment. They want to study people with chronic~     hepatitis B infection to find out the best time to stop treatment and prevent the disease~     from causing further liver damage.~      Objectives:~        -  To study the safety and effectiveness of withdrawing antiviral treatment for chronic~          hepatitis B after at least 4 years of treatment.~        -  To determine whether stopping long-term antiviral treatment for chronic hepatitis B~          makes the infection worse.~      Eligibility:~      - People who are at least 18 years of age; have been taking antiviral drugs to treat chronic~     hepatitis B for at least 4 years; and are being evaluated to stop treatment.~      Design:~        -  Those in the study will be screened with a physical exam, medical history,~          questionnaire, and blood tests. They will remain under the care of their regular doctor~          during the study.~        -  They will have an abdominal ultrasound to study scarring in the liver, if they have not~          had one in the past year.~        -  Those without detectable levels of the hepatitis B virus in their blood will stop~          antiviral treatment. They will have monthly blood tests for the first 6 months to check~          virus levels, and then every 3 months afterward.~        -  Those whose blood tests show an increase in virus levels will restart antiviral~          treatment as directed by the study doctors and their personal doctor.~        -  All those in the study will be monitored until the end of the study.~   "
112662|NCT01581541|"~     Background:~      - PU-H71 is an experimental drug used to treat cancer. It works by blocking a protein in~     tumors. When this protein is blocked, it affects other proteins inside the cell that cancers~     need to grow. Researchers want to study whether PU-H71 is a safe and effective way to treat~     solid tumors and non-Hodgkin's lymphoma.~      Objectives:~      - To evaluate the safety and effectiveness of PU-H71 in solid tumors and non-Hodgkin's~     lymphoma that have not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or non-Hodgkin s lymphoma that~     have not responded to standard treatments.~      Design:~        -  Patients will be screened with a physical exam, medical history, blood tests, and~          imaging studies.~        -  Patients will receive PU-H71 as a 1-hour dose on days 1 and 8 of a 21-day cycle of~          treatment. The first treatment cycle will be done in the hospital so that patients can~          be monitored. The next treatment cycles will be done on an outpatient basis.~        -  Patients will have blood and urine tests and eye exams.~        -  Patients will provide tumor samples for study.~        -  Patients will have imaging studies to monitor tumor response to treatment.~        -  Patients will continue to take PU-H71 for as long as side effects remain tolerable and~          their tumor or lymphoma does not worsen. Study researchers may adjust the dose if~          needed.~   "
112663|NCT01581528|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors identify learn more about biomarkers related to cancer. It~     may also help doctors to find better ways to treat cancer.~      PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic~     leukemia (T-ALL).~   "
112664|NCT01581515|"~     The purpose of this study is to compare the degree of stent malapposition on an immediate~     optical coherence tomography (OCT) after nominal stent pressure and at a final~     post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the~     intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM~     stents versus Xience PRIME® stents.~   "
112665|NCT01581502|"~     The purpose of this study is to determine choice of anticoagulant therapy during acute and~     chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke~     recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.~   "
112666|NCT01581489|"~     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by~     increasing the infant's iron endowment at birth. Compared to early clamping, a delay in~     clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of~     bodyweight to the newborn infant.~      The results of previous intervention studies on delayed clamping are mixed, and few have~     followed the infants beyond the perinatal period. All longer follow up studies have been~     performed in low income countries except for the investigators earlier study, showing less~     iron deficiency and improved iron stores after delayed cord clamping at 4 months of age.~      The main objective of the current study is to assess whether the time of cord clamping~     affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants.~     The investigators hypothesis is that as delayed cord clamping improves iron stores at 4~     months, this could affect the child's development positively.~   "
114148|NCT01562080|"~     The aim of this study is to demonstrate whether, along with dietary recommendations,~     Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a~     change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III~     (ATP III)~   "
112668|NCT01581463|"~     Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10~     Million in the United States and 80 Million patients world-wide are hypothyroid, usually the~     result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result~     from low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid~     hormone production by the thyroid gland. Every tissue in the body is a thyroid hormone~     target and hypothyroid symptoms can be debilitating.~      BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt~     utilized as the active ingredient in currently marketed products.~      The current gold standard for treatment of hypothyroidism are products containing~     Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3~     by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally~     not euthyroid as measured by clinical presentation, a condition hypothesized to result from~     low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of~     conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the~     patient.~      BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented~     formulation and granulation procedure that solves multiple clinical and stability problems~     associated with T3-based products. Thus, BCT303 is designed to have:~        1. Increased shelf stability to ensure the maintenance of claimed dosage.~        2. A sustained-release profile to minimize side effects associated with spikes in serum T3~          levels.~        3. Uniformity of dose between production batches and between tablets.~   "
112669|NCT01581450|"~     Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia~     induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in~     20 healthy volunteers.~      The duration of participation for each volunteer is expected to be around 9 weeks with the~     performance of 4 experimental session 2 weeks apart.~      The selection visit will last half a day; each experimental session will last half a day;~     the study end will last 2 hours maximum.~   "
112670|NCT01581437|"~     The 64 pole basket catheter used for the mapping procedure will be defined atypical sites~     which sustain atrial fibrillation. The ablation through the driver will lead to more rapid~     ablation of the atrial fibrillation.~   "
112671|NCT01581424|"~     The investigators will perform a study with two major components. The first is a natural~     history study of untreated Fabry patients. This study component will detail kidney~     microscopic structural changes in Fabry patients before starting enzyme replacement therapy~     and will correlate these changes with kidney function, including glomerular filtration rate~     and urinary albumin excretion rate. The investigators will perform studies on samples~     obtained at baseline, or before enzyme replacement therapy is initiated. The goal of our~     study is to find kidney microscopic changes in the biopsies that are associated with kidney~     disfunction. Our hypotheses for this study are:~        1. Much of the natural history of Fabry renal structural changes will occur without~          detectable renal functional alterations.~        2. Structural changes associated with the initial onset of proteinuria and those~          associated with the subsequent progressive loss of filtration function will differ and~          will be best described by non-linear models.~        3. There will be sufficient precision of Fabry renal structural-functional relationships~          to support renal structure as an acceptable clinical trial surrogate endpoint for later~          renal functional deterioration.~      The second component examines the effects of age and gender at start of enzyme replacement~     therapy (ERT), as well as dosage levels of ERT on the renal cellular clearance of GL3 from~     Fabry patients by comparing baseline to follow-up kidney biopsies performed 5, 11, and 60~     months later, with all comparisons matched for ERT treatment duration. Our hypotheses for~     this component of the study are as follows:~        1. Enzyme Replacement Therapy(ERT) instituted at younger ages is more effective in~          reducing podocytes(PC),distal tubular cells(DTC),and arterial smooth muscle cells~          (ASMC)GL-3 than in older Fabry patients.~        2. Earlier institution of ERT will stabilize PC numbers while later ERT institution,~          especially in proteinuric adults, may not prevent progressive decline in PC numbers and~          associated glomerular sclerosis, tubulointerstitial injury, and GFR loss.~        3. Whereas lower ERT dose may effectively clear GL-3 from endothelial and mesangial cells,~          it will be less effective in clearing GL-3 from PC and also from DTC and ASMC.~        4. Affected cells will be cleared of GL-3 equivalently in females and males.~   "
112672|NCT01581411|"~     1. Study hypothesis: Injection of t-PA, a thrombolytic drug (clot busting medicine)into~          the ophthalmic artery (the blood vessel feeding the eye), in patients with recent~          severe central retinal vein occlusion, may reopen the central retinal vein and improve~          retinal blood flow, which may in turn improve visual acuity and prevent the long-term~          complications of the disease.~        2. Experimental intervention: An outpatient procedure during which the ophthalmic artery~          is selective catheterized (with a small plastic tube called a microcatheter introduced~          from the artery of the leg) and infused with t-PA during two hours.~   "
112673|NCT01581398|"~     The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b~     (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of~     180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study~     will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending~     on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be~     enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b~     group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral~     daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients~     will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon~     alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy~     and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be~     followed for 24 weeks after the end of therapy.~   "
112674|NCT01581385|"~     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging~     method, Acoustic Radiation Force Impulse (ARFI) ultrasound, to describe the composition and~     structure of atherosclerotic plaques. The hypothesis being tested is that in vivo,~     transcutaneous ARFI ultrasound delineates plaque composition and structure in human carotid~     arteries.~   "
112691|NCT01581151|"~     This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to~     monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or~     central retinal vein occlusion. This is based on the null hypothesis that dexamethasone~     implant with rescue ranibizumab has inferior best corrected visual acuity at six months~     compared to monthly ranibizumab alone.~   "
112692|NCT01581138|"~     The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in~     subjects who have chronic hepatitis C and have not received treatment yet.~   "
112693|NCT01581125|"~     The purpose of this study is to test the hypothesis that sleep and performance depend on~     length of time awake, length of time asleep, the amount of sleep over several sleep~     episodes, and circadian phase.~   "
112768|NCT01580137|"~     The purpose of this study is to find out if we can predict the progress of acute upper~     respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by~     symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or~     nitric oxide measurement.~   "
112675|NCT01581372|"~     Background:~      Cardiovascular disease (CVD) is the cause of one-third of all deaths in Canada. One~     important risk factor for CVD is dyslipidemia. The Canadian Health Measures survey, which~     was conducted from 2007-2009, found that roughly 36% of Canadians had unhealthy levels of~     LDL. Despite strong evidence and clear practice guidelines for the management of this risk~     factor, it remains poorly treated.~      Pharmacists are front-line primary care professionals who see patients at risk for~     cardiovascular disease more frequently than other healthcare professionals. As such,~     pharmacists have the opportunity to systematically and proactively identify patients with~     undertreated dyslipidemia, as one public health approach to chronic disease management.~      The objective of this study is to evaluate the effect of enhanced pharmacist care (i.e.,~     participant identification, assessment, care plan development, education/counseling,~     prescribing/titration of lipid-lowering medications and close follow-up) on the proportion~     of participants achieving target LDL-cholesterol levels.~      Hypothesis: Enhanced pharmacist care will result in a more significant decrease in LDL-c~     levels, than that observed in the usual care patients.~      Design:~      This is a randomized controlled trial of enhanced pharmacist care. The study will be~     conducted in twelve community pharmacies in Alberta, including several Safeway Pharmacies.~     The participant population will be composed of adults with uncontrolled dyslipidemia as~     defined by the 2009 Canadian Dyslipidemia Guidelines. The primary intervention will be~     pharmacist directed dyslipidemia care. Participants randomized to usual care will receive~     usual care from their pharmacist and physician.~      Study Implications:~      To the investigators knowledge, this study is the first randomized trial of pharmacist~     prescribing in dyslipidemia. This study will have important implications for improving~     patients' access to care, especially as most provinces are proceeding with granting~     additional prescribing authority to pharmacists. The ability to conduct this study in a~     province where pharmacists already have the ability to prescribe is unique. The results will~     also encourage more pharmacists to get involved in cardiovascular prevention and will~     increase the number of prescribers in the area of dyslipidemia.~   "
112676|NCT01581359|"~     The purpose of this study is to determine whether the administration of an analogue of~     gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an~     IVF may improve the response to ovarian stimulation, implantation rate and clinical~     pregnancy rate in patients with endometriosis/ endometriomas.~   "
112677|NCT01581346|"~     In the course of their disease patients with Non small cell lung cancer (NSCLC) often~     experience impaired psychological and physical functioning resulting in a reduced quality of~     life (QoL). The aim of the study is to explore the feasibility and the effects of an eight~     weeks combined muscle strength and endurance training on physical capacity and QoL.~   "
112678|NCT01581333|"~     Clinical trial intended to reduce the antibiotic therapy duration in in-hospital patients~     with haematological diseases who develop fever and low white blood cell count (neutropenia).~   "
112679|NCT01581320|"~     A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to~     evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the~     improvement of vitamin D in postmenopausal women with osteoporosis.~   "
112680|NCT01581307|"~     The purpose of this study is to evaluate the safety and impact on survival with treatment~     with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and~     oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory~     metastatic pancreatic cancer with predominantly liver metastases.~   "
112681|NCT01581294|"~     NOR-DMARD is a register-based longitudinal observational study of which the main objectives~     are to study the effectiveness of treatment of inflammatory joint diseases with biological~     disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease~     activity, health related quality of life, function and joint damage, and to study the~     long-term safety of such treatment. Other objectives include the assessment of~     cost-effectiveness of treatment, to identify and and validate clinical, genetic and~     immunological predictors of efficacy and adverse events, to assess the impact of treatment~     with biological DMARDs on work participation and work productivity, to investigate different~     strategies for use of biological DMARDs, to assess the performance of different outcome~     measures, and to ensure a systematic and timely follow-up of patients treated with~     biological DMARDs.~   "
112682|NCT01581281|"~     The purpose of this research study is to test two medicines for migraine prevention in~     children and adolescents.~   "
112683|NCT01581255|"~     Mechanical ventilation, although life-saving, damages the lungs through what is known as~     ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as~     a ventilation method that may be less injurious to the lungs than conventional mechanical~     ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the~     OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress~     syndrome randomized to high frequency oscillation ventilation vs conventional lung~     protective ventilation. The present study is a substudy of the OSCILLATE trial looking at~     biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled~     in OSCILLATE. The objective is to look for biochemical evidence of decreased~     ventilator-induced lung injury in patients treated with high frequency oscillation~     ventilation relative to conventional ventilation.~   "
112684|NCT01581242|"~     This is a randomized, open-label, three-sequence, three-period, three-treatment clinical~     trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir~     dipivoxil after oral administration in healthy male subjects.~   "
112685|NCT01581229|"~     To assess the safety and efficacy of noninvasive positive pressure ventilation for patients~     with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration~     oxygen therapy.~   "
112686|NCT01581216|"~     Fatigue related to cancer is the most common reported symptom and it prevents 91% of~     patients of having an active life, and in several cases, the fatigue persists for several~     months or even years after treatment. Fatigue does cause an impact in all dimensions of~     patients' quality of life and it is the main cause of reduction in patients' daily life~     activities.~      Fatigue is reported by cancer patients in all phases of the illness as one of the most~     frequent symptoms, especially in cases presenting metastases.~      In order to monitor fatigue, pharmacological and non-pharmacological techniques may be~     employed, such as physical activity. Physical exercise has shown positive results in~     mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients'~     quality of life.~      This study will assess the efficiency of physical activity upon controlling the fatigue and~     quality of life in patients with advanced stage of the disease at the end of 7 days using~     FACT-F subscale.~   "
112687|NCT01581203|"~     The purpose of this study is to estimate efficacy, as determined by the proportion of~     subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as~     Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at~     post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who~     are treatment-naive.~   "
116452|NCT01531972|"~     This is an open-label study investigating the relationship between SEP-228432 and SEP-228431~     (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT~     occupancy, both measured by SPECT imaging.~   "
112694|NCT01581112|"~     The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that~     armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living~     microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up~     scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by~     a trained smelling panel, the bacteria living on the armpit/foot is examined by means of~     molecular techniques. The microbial transplantation and its follow-up happens under the~     supervision of a doctor.~   "
112695|NCT01581099|"~     Introduction- Primary prevention is the main strategy to control the global burden of~     cardiovascular disease. In clinical practice, food restriction represents a valuable~     preventive resource. However, low adhesion rates and diet abandonment are considered~     important obstacles in treatment. Considering the discovery of new markers and mechanisms~     that relate food restriction and to all other cardiovascular risk factors, it is possible~     and necessary to seek for efficient alternatives to increase adherence and effectiveness of~     the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote~     food restriction. The bariatric surgery have gained importance not only for its potential~     application in obesity treatment but also in the control of cardiovascular risk factors~     refractory to medical treatment. Among bariatric operations, there is a group called~     digestive adaptations III that has specific characteristics.This surgical intervention~     modifies intestinal tract by reducing gastric volume and performing an anastomosis between~     ileum and stomach, creating a bipartition in the gut. This structural modification promotes~     satiety and increased insulin sensitivity more intensely than other surgical strategies. The~     effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers~     related to the development of atherosclerosis are not yet established.~      Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and~     laboratory parameters and cardiovascular risk factors.~      Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal~     obesity will be included in the study. Of this group, half will be randomly selected to~     perform the Digestive Adaptations III surgery. All participants will undergo clinical and~     biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four~     months after surgery. On these occasions besides the lipid profile and glucose, we will~     determine incretin hormones, adipokines and assess the amount of epicardial fat.~   "
112696|NCT01581086|"~     This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension~     PAH) in HIV and COPD patients.~   "
112697|NCT01581073|"~     The purpose of this study is to ask whether treating non-diabetic chronic kidney disease~     (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and~     13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The~     investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher~     adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to~     11g/dL.~   "
112698|NCT01581060|"~     The aim of part 1 of this study is to determine the optimal biological dose (OBD) and~     maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the~     chronic treatment in part 2. The aim of part 2 is to further determine the safety and~     tolerability of chronic treatment with WX-554.~   "
112699|NCT01581047|"~     Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and~     dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic~     can't be changed, but the dosing scheme can be optimized. Recent studies proved that an~     optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum~     antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is~     due to the pathophysiologic processes in the patients on intensive care units: increased~     distribution volume, hypoproteinemia, organ failure… The investigators guess that similar~     processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and~     cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in~     seriously ill patients are better known, physicians are more confident prescribing these~     drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously~     ill patients, can help to give the physician the confidence to prescribe these~     small-spectrum antibiotics.~      In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic~     acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a~     central catheter on different moments after one administration of the antibiotic in the~     steady state phase. All the patients are prescribed the antibiotics for the treatment of~     their infections: they get the antibiotic therapy anyway. By measuring the concentrations on~     different moments after one administration, the investigators can reconstruct the~     pharmacokinetic function.~   "
112700|NCT01581034|"~     This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6~     week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous~     systems in patients with coronary artery disease. The investigators hypothesize that PADMA~     28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic~     nervous systen and the blood inflammatory markers in patients with coronary artery disease~     compared to placebo treatment.~   "
112701|NCT01581021|"~     Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is~     the main method of correcting this deformity. Rods are attached to the spine to make it~     strait. There are two ways to fix these rods to the bone of the spine: laminar hooks or~     pedicle screws. Hooks are an older form of fixation and do not penetrate the bone, but are~     instead placed over a part of the vertebra called the lamina. Screws are newer and do~     penetrate the bone. Screws are placed into the part of the vertebra called the pedicle. Most~     surgeons think screws correct scoliosis better than hooks. The current literature agrees~     that screws are better for deformity correction in the lumbar spine and patients with severe~     deformity. There is disagreement in the literature regarding which works better in the~     thoracic spine in less severe deformity. There are no randomized, controlled trials in the~     literature that examine whether constructs that use hooks in the thoracic spine and screws~     in the lumbar spine (called hybrid constructs) work as well as all-screw constructs. This~     clinical study is a randomized controlled trial being conducted to evaluate treatment~     outcomes in patients with scoliosis undergoing surgical correction for their curves using~     either all-screw or hybrid constructs as fixation devices. The study population is limited~     to those with less severe deformity and the investigators' hypothesis is that hybrid~     constructs will be as acceptable as screws in terms of correction.~   "
112702|NCT01581008|"~     The overall goal of this study is to evaluate the pilot implementation of two palliative~     care interventions in veterans with chronic heart failure at the Denver VA Medical Center.~     This is a study of behavioral and care strategy interventions and involves no~     investigational drugs or devices.~   "
113125|NCT01575470|"~     The purpose of this study is to determine if bone marrow harvest, BMMNC separation, and~     re-infusion in adults with acute severe TBI is safe and will improve functional outcome.~      12/09/2015 Update: The study is closed to new enrollment and all follow-up visits have been~     completed. Data analysis is underway.~   "
112703|NCT01580995|"~     The purpose of this study is to examine the effects of valacyclovir in patients who have~     chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have~     antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly~     causes cold sores or fever blisters, also known as herpes labialis, but most persons do not~     have any symptoms at all. Valacyclovir is a medication which is approved by the Food and~     Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat~     chronic hepatitis C infection.~      The study will take 16 weeks. Participants will be assigned to take either the study drug,~     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and~     patients will not know which medication they are receiving. Study visits will occur every~     two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V.~     Sonny Montgomery VA Medical Center in Jackson, Mississippi.~   "
112704|NCT01580982|"~     The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined~     from tumor tissue or tumor cell lines derived from available archival samples and/or from~     standard-of-care re-biopsy upon suspected tumor progression.~   "
112705|NCT01580969|"~     The primary objective of step 1 is the rate of adverse events of minocycline and bevacizumab~     during reirradiation and of step 2 is the response rate to bevacizumab, reirradiation, and~     minocycline. The secondary objectives are the response rate, PFS-3, PFS-6, and effects on~     quality of life and cognition from repeat radiation and bevacizumab.~   "
112706|NCT01580956|"~     Variable PSV is a new ventilatory mode which delivered a pressure support variable from 0~     to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior,~     sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and standard (or fixed)-PSV~     during the weaning phase of critically ill patients who required mechanical ventilation.~   "
112707|NCT01580943|"~     The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine~     and 0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine~     non-alcohol base mouth rinse (Corsodyl Care®).~   "
112708|NCT01580930|"~     The purpose of this study is to determine if individuals involved in exercise training~     change habitual activity and inactivity behavior outside of exercise training. Eligible~     participants were randomly assigned to one of four groups: control, exercise training,~     sedentary time reduction, or exercise training plus sedentary time reduction. It was~     hypothesized that participants in the exercise training group will compensate for exercise~     training by reducing free-living physical activity behavior and increasing sedentary time.~     Participant free-living behavior was monitored for one week at baseline, 3, 6, 9 and 12~     weeks using an activPAL wearable monitor.~   "
112709|NCT01580917|"~     The purpose of this pilot study is to compare the dynamic response of microcirculation in~     the skin on the bottom of the big toe after applying controlled plantar stress in 25~     diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better~     understand the role of local hypoxia in neuropathic foot ulceration in subjects with~     diabetes.~      The investigators hypothesize that if they apply a gait simulating load to the plantar foot~     and measure microvascular function, diabetic individuals will demonstrate an increased delay~     in reestablishing microvascular flow compared to healthy individuals.~   "
112710|NCT01580904|"~     The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug~     treatment and to improve their quality of life. This study will measure the impact of~     pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single~     blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the~     intervention group will be held the pharmacotherapeutic follow using a methodology called~     the practice of pharmaceutical care, which identifies and resolves problems related to~     drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline~     glucose, total cholesterol and its fractions (for example LDL), all these measures will be~     made in the intervention group and control group. Patients will be followed for 24 weeks,~     and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95%~     and a significance of p <0.05, and will use the Student t test, chi-square analysis of~     variance (ANOVA) and others if necessary. Expects good results and serve as a model for~     other researchers.~   "
112711|NCT01580891|"~     The objective of this study is to evaluate the efficacy and safety of the test formulation~     of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed~     formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients~     with tinea pedis and to show the superiority of the active treatments over placebo when~     dosed once a day for 28 days.~   "
112712|NCT01580878|"~     The primary objective of this study is to determine the comparability of the safety and~     efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra®~     (the reference listed drug) in subjects with interdigital tinea pedis. It will also be~     determined whether the efficacy of each of the two active treatments is superior to that of~     the vehicle cream (placebo).~   "
112713|NCT01580865|"~     Prospective, multi-center, randomized, controlled, trial to compare tacrolimus with~     mycophenolate mofetil (MMF) for induces complete remission in lupus nephritis patients. The~     study duration is one year.~      Research hypothesis~        -  The proportion of patients who have achieved complete remission between regimen of~          tacrolimus plus prednisolone is greater than MMF plus prednisolone as an induction~          therapy in lupus nephritis.~   "
112714|NCT01580852|"~     BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes~     in several body systems including the endocrine system. To date, there have only been a~     small number of reports that balneology can reduce blood sugar Levels in patients with type~     2 diabetes mellitus (DM].~      OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose~     levels in patients with type 2 DM.~      METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice~     daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath~     continue for 20 minutes.~   "
112715|NCT01580839|"~     The primary hypothesis being tested in this trial is that ischaemic stroke patients selected~     with significant penumbral mismatch (according to imaging criteria) at 4.5 (or 3 hours~     depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke'~     (WUS) will have improved clinical outcomes when given intravenous tissue plasminogen~     activator (tPA) compared to placebo.~   "
112717|NCT01580813|"~     People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of~     certain fats in their blood. The blood vessels and heart of most of these individuals do not~     work normally and people with T2DM also have an impaired ability to perform exercise. The~     purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily~     decrease the level of fat in the bloodstream of people with T2DM and observe the~     physiological changes to blood vessel function and exercise capacity and insulin~     sensitivity. This will help the investigators to understand ways of improving blood vessel~     function and the ability to exercise effectively in people who are overweight or have T2DM.~   "
112718|NCT01580800|"~     The purpose of the National Breast Cancer Lymphedema Registry is to collect health~     information in order to study the lymphedema as a complication of breast cancer treatment.~     The investigators hope to learn whether early diagnosis will help to prevent lymphedema or,~     if it does occur, to reduce the severity.~   "
112719|NCT01580787|"~     The objective of this work was to compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the balance, functionality and cognition of patients with Parkinson´s disease. It was a~     prospective, single blinded, randomized clinical trial performed at Brazil Parkinson~     Association and Center of Research of the courses of Speech Therapy, Physical Therapy and~     Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages~     1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and~     experimental group, 16 each one.~      The study was finished at december 2011.~   "
112720|NCT01580774|"~     The purpose of this study is to determine whether a post-discharge telephone call to general~     medical patients discharged home will improve quality of care and adherence, and reduce~     hospital readmission.~   "
112721|NCT01580761|"~     Insufficient sleep may be one of the most common, and most preventable, obesity risk~     factors. The investigators wish to determine whether 14 nights of modest sleep restriction~     results in increased energy balance, thus potentially increasing the risk of obesity. The~     investigators hypothesize that sleep restriction will result in increased energy balance.~   "
112722|NCT01580748|"~     There is currently no effective treatment of bronchiectasis other than treating its~     complications such as infection, bleeding, etc. Roflumilast is a newly developed~     anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that~     Roflumilast might be effective in symptomatic bronchiectasis patients~   "
112723|NCT01580735|"~     The primary objective of this study is to examine if the combination regimen of ARQ 197 with~     erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating~     mutation EGFR who progressed on EGFR-TKI monotherapy.~   "
112724|NCT01580722|"~     The purpose of this study is to determine which surgical method is better for anterior~     cruciate ligament teas in outcomes.~   "
112725|NCT01580709|"~     Differentiating malignant from benign bile duct strictures is a conundrum, since no~     diagnostic test is highly sensitive for diagnosing cancer. While ERCP is effective in~     palliating obstructive jaundice, standard diagnostic tools in ERCP have a low diagnostic~     sensitivity and confirm the stricture's etiology in <50% of cases. During the first ERCP,~     standard practice is to obtain routine cytology (RC) using a single brush sample. If this is~     not diagnostic, patients often undergo repeat ERCP, endoscopic ultrasound or other,~     increasing health care costs. The incremental yield of performing alternate ERCP-based~     diagnostic tools during the first ERCP including fluorescence in situ hybridization (FISH),~     cholangioscopy w/biopsy and multiple brushes for routine cytology is currently unknown.~     There are no studies quantifying the amount of testing utilized to firmly diagnose the~     etiology of the stricture, or the most efficient combination of diagnostic tools during the~     first ERCP. These are important knowledge deficiencies since a definitive tissue diagnosis~     during the first ERCP could reduce the need for downstream tests and expedite treatment,~     thereby improving patient-centered and economic outcomes. The added costs of using multiple~     tools during the first ERCP may be offset by these benefits.~      Among patients with indeterminate bile duct strictures, the investigators hypothesize that a~     multimodality approach will be more sensitive without a significant reduction in specificity~     compared to multiple brush samples for routine cytology. The investigators will test this~     hypothesis using an experimental trial design by randomizing patients during their first~     ERCP to multiple brushing samples for cytology vs. a single brush sample for cytology + FISH~     + cholangioscopy w/biopsy. To obtain preliminary data for a definitive multi-center trial,~     the investigators propose a pilot and feasibility study to compare the performance~     characteristics of each approach by evaluating the prospective clinical course, including~     treatment delay, quality of life, and life expectancy for each enrolled patient. If our~     hypothesis is validated in a subsequent definitive study, the standard approach to tissue~     sampling during the first ERCP may be altered.~   "
112726|NCT01580696|"~     Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial~     cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T~     lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory.~     The purpose of this study is to test whether a peptide-based vaccine consisting of the E39~     peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating~     factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune~     response. Furthermore, the investigators intend to determine the best dose of the vaccine to~     utilize to produce this immunity most efficiently. The investigators will determine whether~     immunity to FBP will prevent clinical recurrence. Additionally, the investigators will~     compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu~     protein) in ovarian and endometrial cancer patients in preparation for studying a~     combination vaccine.~   "
112727|NCT01580683|"~     The purpose of this study is to determine if vitamin C decreases the chance of developing~     atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery.~     This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in~     about one third of patients. It poses extra risks to people who develop it. Our hypothesis~     is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.~   "
112728|NCT01580670|"~     The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's~     Disease Activity Index (PCDAI) and other evaluation indicators in pediatric patients with~     moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at weeks~     0, 2, and 6, then every 8 weeks after week 14 up to week 46, and at a dose of 10 mg/kg if~     the effect is attenuated. The safety and pharmacokinetics are also evaluated.~   "
112729|NCT01580657|"~     Randomized clinical trials of HIV prevention interventions typically include extensive~     baseline assessments of the risk behaviors that interventions target. Such pretests have the~     potential to direct participants' attention to the factors that put them at risk of HIV~     infection. Evidence from intervention study control groups, the motivational enhancement and~     attitude change literature, and our preliminary studies suggest that assessments that lead~     people to think about behaviors with potentially negative outcomes lead to motivation for~     risk behavior reduction. As a consequence, HIV intervention research using baseline~     assessments may not accurately predict the impact of a given HIV prevention intervention~     outside of the research context, in particular when interventions are evaluated among~     high-risk, isolated individuals. However, the actual effects as well as public-health~     consequences and mechanisms of HIV assessment reactivity have never been systematically~     tested.~      The proposed assessment reactivity study will be conducted in South Africa, a country with~     high levels of HIV prevalence, incidence, and stigma. The Republic of South Africa's~     HIV/AIDS epidemic has emerged recently relative to other sub-Saharan countries, and yet~     21.5% of South Africans aged 15-49 -- more than 1 in 5 people -- are infected with HIV~     (UNAIDS, 2004). Despite the common presence of HIV in South Africa, it remains largely a~     hidden disease and HIV-related stigma interferes with peoples' ability to protect themselves~     through open discussion or spontaneous reflection on personal risk. Under these conditions,~     it is reasonable to expect a sizable effect from directing people's attention to their HIV~     relevant behaviors, an effect that could be incorrectly ascribed to brief interventions used~     in low-resource settings. The conditions in South Africa, therefore, heighten the clinical~     and public health significance of the assessment reactivity issue in that (a) it is vital to~     understand how reactivity may affect the results of behavioral intervention trials, and (b)~     it may be possible to capitalize on assessment reactivity through brief, assessment-based~     interventions.~      This study will allow us to achieve our primary aim:~      1. To separate the effect of a brief HIV-risk reduction intervention from the potential~     effects of two types of baseline assessment commonly applied in HIV intervention research: a~     detailed, calendar-based assessment and a general frequency assessment. The detailed~     calendar-based assessment will potentially lead participants to observe themselves in~     specific risk-behavior situations, providing them with the opportunity to reassess the risk~     involved in those situations in light of their health goals and thus motivating them for~     behavior change. The general frequency assessment will merely prompt participants to~     estimate the overall frequency with which they engaged in several HIV-related behaviors. The~     effect of these assessments on participants' sexual behavior will be examined alone and in~     combination with the HIV-risk reduction intervention.~      In addition, this project has two important secondary aims:~        1. To generate urgently needed additional efficacy data for a promising HIV risk reduction~          intervention culturally tailored for use and found to be effective in South Africa~        2. To determine potential HIV preventive effects of different types of HIV risk behavior~          assessments on risk behavior reduction in South Africa for future intervention~          development~      To achieve the above aims, the investigators will:~        1. Recruit 1500 patients (50% women), age 18-44, from the Spencer Rd. STD Clinic, Cape~          Town, South Africa.~        2. Randomly assign participants within gender to one of 6 study arms in a modified Solomon~          Four-Group (SFG) design. The 2 (intervention: standard of care vs. an efficacious~          theory based HIV prevention intervention) x 3 (baseline face-to-face interview: none~          vs. basic single-item frequency questions vs. detailed partner-by-partner~          calendar-based interview) factorial design is depicted below:~   "
112730|NCT01580644|"~     The purpose of this study is to evaluate the amount of GLPG0187 present in the blood~     (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy~     subjects.~      Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and~     dose proportionality of the best formulation.~      Furthermore, during the course of the study, safety and tolerability will be characterized.~   "
112731|NCT01580631|"~     Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415~     nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's~     microvasculature and enhances detail on the surface of the mucosa revealing subtle changes.~     Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by~     angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise~     for the prediction of dysplasia in BE mucosa.~      NBI images of the BE mucosa obtained during endoscopy will be classified by academic~     endoscopists and community endoscopists initially. The endoscopists will then be asked to~     predict histopathology based on the NBI surface patterns. This clinical trial will evaluate~     the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI)~     classification system of surface patterns and its ability to differentiate dysplastic versus~     non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance~     in expert academic centers and in community GI practice as well. Their performance will be~     evaluated for accuracy, sensitivity, specificity, positive predictive value and negative~     predictive value of each pattern that is visualized on NBI.~   "
112732|NCT01580618|"~     The objective of the study is to determine the safety and efficacy of TNK infusion for the~     treatment of loculated pleural effusions in patients with known malignancy compared to~     normal saline infusion.~   "
112733|NCT01580605|"~     This study is conducted in Europe. The aim of this study is to extract data from the French~     National Registry holding information about patients having initiated growth hormone therapy~     with the objective to describe patients receiving growth hormone therapy, assess efficacy~     and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.~   "
112734|NCT01580592|"~     Urticaria is a very frequent skin condition characterised by transient wheal and flare type~     skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent~     form of physical urticaria that is characterized by the development of wheal and flare type~     skin reactions due to the release of histamine and other proinflammatory mast cell mediators~     following exposure of the skin to cold. Among all physical urticaria subtypes the frequency~     of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU~     are known to severely impair the quality of life of affected patients.~      The treatment of choice in CCU, as well as in other inducible forms and spontaneous~     urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1~     blockers is significantly more effective in reducing symptoms in cold urticaria than~     standard-dose treatment. Thus, patients who cannot be sufficiently controlled with~     standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard~     dose as recommended by the new international guidelines for the management of urticaria.~      Previous phase II studies in patients with chronic spontaneous urticaria have shown~     favorable results for the treatment with omalizumab (Xolair®). Proof-of-concept data from~     completed studies suggest that omalizumab improves urticaria in patients with chronic~     spontaneous urticaria who have failed treatment with H1 antihistamines as well as those who~     have failed treatment with a combination of H1 and H2 antihistamines and a leukotriene~     receptor antagonist. In addition, two case reports of patients with severe therapy~     refractory CCU treated with omalizumab reported a complete response with no urticarial~     symptoms after cold challenge. In summary, these data suggest that omalizumab may have a~     beneficial effect in the treatment of CCU.~   "
112735|NCT01580579|"~     Lung cancer [LC] is the leading cause of cancer death worldwide. The standard treatment of~     locally advanced lung cancer unresectable or marginally resectable is combination therapy~     with radical or preoperative chemoradiation. The local control rates and survival with this~     treatment modality have increased by more than 30%. Radiotherapy [RT] with technical molded~     3D [3D-CRT, Three-Dimensional Conformal Radiation Therapy] or IMRT [intensity-modulated~     radiation therapy] has allowed that the total dose of radiation has increased which leads to~     a direct benefit on the results treatment.~      Between 17-30% of patients are susceptible to pneumonitis due to radiation [NR]. This~     complication may appear at the end of the RT or up to 6 months after the treatment. In~     severe cases, mortality can reach 50%.~      It's well known that in various diseases, functional abnormalities precede the clinical~     manifestations. The degree of pulmonary failure secondary to RT is measured following the~     standards of the Radiation Therapy Oncology Group who ranks in degrees [0 to 4].~      Not precisely known factors that influence the development of NR.~   "
112736|NCT01580566|"~     The purpose of this study is to determine if a sizable myocardial infarction (heart attack)~     results in negative changes to renal structure and function (i.e. has a negative impact on~     the kidneys).~      To determine if the renal response to a myocardial infarction is a predictor of the patients~     future health.~   "
112737|NCT01580553|"~     The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in~     treatment of Chinese patients with heart failure.~      A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical~     study was performed.~      Treatment period: 7 days, follow-up: 1 month~   "
112738|NCT01580540|"~     The study aims to show non-inferiority in the clinical performance of the investigational~     assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline~     eligible subjects.~   "
112739|NCT01580527|"~     Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality~     partially related to the altered nutritional status of the patients. The perioperative~     malnutrition is a major risk factor of postoperative complications and worsens the prognosis~     of the patients. The perioperative artificial nutrition has for objectives to correct the~     preoperative malnutrition, and to maintain the nutritional status in the post-operative~     period. The current guidelines in surgery are in favour of a realisation of a perioperative~     artificial nutrition support that privilege the enteral nutrition. However, after~     pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the~     early postoperative period, although rare studies suggest a benefit of the enteral nutrition~     in term of reduction of the post-operative complications. Indeed, no recommendation was~     formulated concerning early enteral nutrition after pancreaticoduodenectomy because few~     studies were realized on its profits.~      The data of the literature report rates of complications (essentially major) from 49 % to 59~     % after major digestive surgery (not only pancreatic) on patients having received a total~     parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early~     enteral nutrition.~      A preliminary prospective study realized in the investigators centre showed a rate of 74 %~     complication versus 44 %, respectively in the total parenteral nutrition and early enteral~     nutrition groups (50 patients in every group, with p < 0.01. All the complications were~     listed prospectively).~      Hypothesis :~      The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at~     least, 19 % complications of any stage according to the classification of Dindo-Clavien (59~     % versus 40 %).~   "
113135|NCT01575340|"~     The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish~     oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy~   "
112740|NCT01580514|"~     Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has~     significant cardiovascular protective effects in various conditions. The investigators~     examined whether conventional use of exenatide at the time of primary percutaneous coronary~     intervention would reduce the infarct size in patients with ST-segment elevation myocardial~     infarction (STEMI).~   "
112741|NCT01580501|"~     PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia~     and restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in~     boys with DMD. The investigators specific aim is to perform an efficient dose-titration~     study to inform the design of a randomized multicenter trial of PDE5A inhibition for~     clinical skeletal muscle and cardiac endpoints.~   "
112742|NCT01580488|"~     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different~     formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the~     psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.~   "
112743|NCT01580475|"~     -  This study examine the effects of training, detraining and retraining, using a combined~          strength and aerobic exercise program, on physiological parameters in patients with~          type 2 diabetes.~        -  Thirteen women with type 2 diabetes followed a supervised aerobic and strength training~          program for 9 months, interrupted for 3 months (detraining) and resumed again for a~          period of 9 months (retraining).~        -  Training improved body mass index, fasting plasma glucose,postprandial glucose,~          glycosylated hemoglobin, peak oxygen consumption,power output and total muscle~          strength. Detraining reversed PPG, HbA1C and physical fitness parameters. Resumption of~          training however, improved further the initial training adaptations.~        -  Diabetic patients should follow a regular and uninterrupted exercise program throughout~          life in order to control glucose metabolism and improve health status.~   "
112744|NCT01580462|"~     The aim of the research is to develop a mathematical model called ADHERENCE index, and to~     evaluate its effectiveness.~   "
112745|NCT01580436|"~     De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following~     mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve~     annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when~     tricuspid annular dilatation is present even in absence of significant TR. However, whether~     such a strategy of prophylactic TVP results in improved outcomes has not been shown to~     date by a prospective randomized study. The investigators goal is therefore to initiate such~     a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients~     scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.~   "
112746|NCT01580423|"~     Substance P is released from sensory nerves and transmits pain information into the central~     nervous system. As pain and dyspnea share many characteristics, including similar~     neurological pathways, it is possible that substance P may contribute to the sensation of~     dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary~     disease (COPD) will provide lower ratings of breathlessness during resistive load breathing~     with oral aprepitant, a medication that blocks the activity of substance P, compared with~     placebo.~   "
112747|NCT01580410|"~     This randomized phase II trial is studying the side effects and how well giving oxaliplatin~     or mitomycin C directly into the abdomen after surgery works in treating patients with~     tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Heating a chemotherapy solution and infusing it directly into~     the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any~     tumor cells that remain after surgery.~   "
112748|NCT01580397|"~     Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas~     (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor~     prognosis with progression-free survival of around 13 weeks and median overall survival of~     approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin~     may be preferentially concentrated in pancreatic cancers that appear to be starved for this~     protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based~     on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin~     without increasing its toxicity, as has been demonstrated in animal studies, and induce~     enhanced anti-tumor efficacy.~   "
112749|NCT01580384|"~     This non-drug, longitudinal, multi-center, multi-national study will evaluate the~     suitability of neurocognitive tests and functioning scales for the measurement of cognitive~     and functioning changes in individuals with Down Syndrome. Tests will be administered at~     clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be~     between 24 and 27 weeks.~   "
112750|NCT01580371|"~     This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT),~     safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients~     with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by~     response rate, progression free survival.~   "
112751|NCT01580358|"~     Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help~     these people improve the quality of life.~   "
112752|NCT01580345|"~     Low birth weight and preterm birth-the leading causes of neonatal morbidity and mortality~     will be prevented by Docosa hexaenoic acid(DHA-omega 3 fatty acid)during pregnancy (from~     <=20 weeks of gestation through delivery)~   "
112769|NCT01580124|"~     Study design:~      Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming~     for atrial fibrillation termination by using a stepwise approach consisting of pulmonary~     vein isolation, biatrial defragmentation aiming for fractionated electrograms and linear~     ablation if required.~   "
112770|NCT01580111|"~     In resolving lactic acidosis among children with severe malarial anemia, there is no~     difference between those transfused with blood of longer storage compared to shorter storage~     age~   "
112771|NCT01580098|"~     Evaluation whether the introduction of large-scale personalized and technology supported~     telemonitoring and health coaching interventions produces benefits in terms of health~     related quality of life, health status and empowerment of patients with type 2 diabetes~     mellitus. In addition, the trials evaluate the economical and organizational impact of the~     new services and examine their acceptability by patients and health professionals.~   "
112753|NCT01580332|"~     Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk~     populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality.~     Unfortunately, the vast majority of positive findings on these CT scans are benign (>95%).~     Currently, an inordinate amount of expensive follow-up testing is required for these~     patients to try to prove who among them truly has a cancer.~      Several new emerging non-invasive and potentially cheaper tests are now being investigated~     to help differentiate patients with cancers versus just benign lung nodules. These new tests~     include a new type of sputum analysis, a breath analysis, a blood test measuring certain~     tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of~     these tests have different sensitivity and specificity rates when looking for lung cancer,~     and it is unclear which test is best.~      This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of~     50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the~     tests. A follow-on study will then perform the same panel of tests on 300 lung nodule~     patients to see which test, or combination of tests, gives the best overall accuracy in~     terms of predicting who really has lung cancer. It is hoped that the use of such a panel~     could lead to dramatically decreased need for expensive and morbid invasive testing for this~     population.~   "
112754|NCT01580319|"~     This research project is about a physical activity intervention in pediatric outpatients to~     try control and prevent heart diseases such as hypertension, obesity, high cholesterol.~   "
112755|NCT01580306|"~     The main objective of this study is to investigate the influence of mild, moderate and~     severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a~     control group with normal renal function after single dose of BI 201335.~   "
112756|NCT01580293|"~     Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to~     form blood clots is missing or not present in sufficient levels. In a person with~     haemophilia A, the clotting process is slowed and the person experiences bleeds that can~     result in serious problems and potential disability.~      The current standard treatment for severe haemophilia A is regularly scheduled infusion of~     FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII,~     prophylaxis may require treatment as often as every other day.~      In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is~     evaluated in subjects with severe Hemophilia A.~      120-140 patients will receive open label treatment with long-acting rFVIII either on-demand~     to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional~     extension to continue treatment for at least 100 total exposure days (ED). Patients on~     prophylactic treatment will receive study drug at dosing intervals between once and twice a~     week depending on their observed bleeding. Patients will attend the treatment centre for~     routine blood samples and be required to keep an electronic diary.~      Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at~     least 50 exposure days may be eligible for this study.~   "
112757|NCT01580280|"~     Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper~     thoracic thrust manipulation will demonstrate significant and clinically important changes~     in outcomes when compared to the mobilization and exercise group.~   "
112758|NCT01580267|"~     Anemia (decreased number of red blood cells) is common in critically ill trauma patients~     admitted to an Intensive Care Unit and is associated with a high rate of blood transfusions.~     This anemia of inflammation is a result of three mechanisms: impaired iron regulation,~     shortened red blood cell life span, and reduced rate of erythropoiesis (a protein that helps~     make new red blood cells).~      Hepcidin, a protein made in the liver, regulates iron and is decreased when iron in the~     blood is low. This can lead to anemia.~      This research study is being conducted to learn how inflammation, hepcidin, and~     erythropoietin interact in critically ill patients. The findings will help in determining~     effective treatment for patients with anemia of inflammation.~   "
112759|NCT01580254|"~     This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops~     preparations, commercially available in Italy, in subjects affected by primary open angle~     glaucoma.~   "
112760|NCT01580241|"~     The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients~     with pancreatic cancer. The investigators would like to analyze its expression pre and post~     treatment, to gauge the correlation between current pancreatic cancer therapies and the~     expression of DCAMKL-1~   "
112761|NCT01580228|"~     This study is being conducted to demonstrate the superiority in progression-free survival~     (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL)~     participants with del 17p or in the overall population who are refractory to either~     fludarabine treatment or chemoimmunotherapy.~   "
112762|NCT01580215|"~     This is an observational prospective single arm multicentre study to observe the effect over~     5 years of Zephyr endobronchial valve therapy for emphysema.~   "
112763|NCT01580202|"~     Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of~     HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in~     such circumstance according to the practice guidelines despite of limited evidence. However,~     failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs~     occasionally, which may lead to liver-related morbidity and mortality as well as premature~     interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM,~     studies on the proper prophylactic antiviral regimen is warranted. The present multicenter,~     prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for~     the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic~     malignancy undergoing cytotoxic chemotherapy.~   "
112764|NCT01580189|"~     The purpose of the study is to examine the effects of consuming protein supplement (whey)~     compared to whole milk immediately after bouts of resistance training on muscular strength~     and body composition.~   "
112765|NCT01580176|"~     This study will be the first study in which the new central venous microdialysis-based~     continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the~     performance of this Continuous GlucoseMonitor, as the measurements will be compared with a~     point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are~     also much less blood samplings / blood loss for the patient and personnel costs.~   "
112766|NCT01580163|"~     The purpose of this research is to observe the efficacy of comprehensive treatment model to~     improve treatment compliance and relapse prevention.~   "
112772|NCT01580085|"~     Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of~     the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in~     intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall~     may ensue. An increased tendency for coagulation has also been reported in OSA. Venous~     stasis, vascular endothelial activation and hypercoagulability are also known risk factors~     for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients~     for the development of pulmonary embolism (PE) however there is limited data about role of~     thromboembolic events in OSA.~   "
112773|NCT01580072|"~     Evaluation whether the introduction of large-scale telemonitoring of patients with COPD~     produces benefits in terms of reduced hospital readmissions, improved health related quality~     of life and health status. In addition, the trials evaluate the economical and~     organizational impact of the new services and examine their acceptability by patients and~     health professionals.~   "
112774|NCT01580046|"~     The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in~     patients with renal dysfunction.~   "
112775|NCT01580033|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine~     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection~     caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the~     infant's normal immune programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age~     of two, and the remaining 60% with a low antibody level and a short duration.~      The immunogenicity and safety of this vaccine has been proved in older children aged 6-23~     months and 2-5 years. And in the phase I study which was conducted in February, 2012, the~     safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The~     phase III study is aimed to further evaluate the safety and the immunization of the vaccine.~     The objective of this study is to evaluate the safety of the group A, C polysaccharide~     meningococcal and type b haemophilus influenzal conjugate vaccine.~   "
112776|NCT01580020|"~     The study is intended to characterize the clinical benefit regarding safety and efficacy of~     a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months~     and a 3-month follow-up period, following the initial 6-month treatment in the respective~     core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).~   "
112777|NCT01580007|"~     Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated~     macrophages and induces expression and release of the cathelicidin, LL-37, a human~     antimicrobial peptide involved in killing of MTB. We aimed to investigate whether treatment~     of newly diagnosed pulmonary TB patients for 2 months with adjunctive PBA and vitamin D~     (Cholecalciferol) in combination with standard DOTS therapy (i) can improve response to~     standard short course TB therapy towards a rapid recovery; (ii) can induce expression of~     LL-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from TB~     patients infected in vitro with MTB; and (iv) does not evoke any adverse effects.~   "
112778|NCT01579994|"~     About 18 patients will take part in the phase 1 portion of the trial. In the beginning of~     the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the~     standard dose of crizotinib. If this dose does not cause significant side effects, it will~     be increased as new patients take part in the study. The study will only be open at Memorial~     Sloan Kettering Cancer Center.~   "
112779|NCT01579981|"~     After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically~     increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim~     of this study is to establish causality between the two observations. By meal testing 10 T2D~     subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1~     week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing~     beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore,~     effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined~   "
112780|NCT01579968|"~     This study is conducted in Japan. The aim of this non-interventional study is to investigate~     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing~     surgery under normal clinical practice conditions.~   "
112781|NCT01579955|"~     This study is conducted in Japan. The aim of this non-interventional study is to investigate~     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal~     clinical practice conditions.~   "
112782|NCT01579942|"~     The investigators are doing this study to find out if they can use electroencephalographic~     (EEG) recordings, which measure brain waves, to predict response to antidepressant~     treatments, as well as to distinguish patients who have depression from those who do not. In~     particular the investigators want to test the usefulness of a new type of analysis of EEG~     recordings called brain network activation or BNA. BNA allows to identify patterns of~     activation in brain networks and to track their changes over time.~   "
112796|NCT01579760|"~     The purpose of this study is to assess the safety of intravitreal aflibercept injection - in~     the treatment of macular edema associated with retinopathy secondary to previous radiation~     therapy.~   "
112797|NCT01579747|"~     Ultrasound have been shown to improve the time needed to locate and block nerves in the non~     obese population. However, its utility is still unknown in the obese population. Ultrasound~     is known to produce poorer quality images in the obese population. This study aims to find~     out if it is a better tool for nerve localization compared to the traditional nerve~     stimulation technique.~   "
112798|NCT01579734|"~     The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer~     prevention in HRT (Hormone Replacement Therapy)users.~   "
112799|NCT01579721|"~     Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity~     and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma.~     However, the feasibility of this procedure in rectal surgery has not been determined yet.~     The aim of this study is to evaluate our initial experience using single port access in~     laparoscopic rectal surgery.~      Design: randomized, prospective clinical study Patients: 40 patients~   "
112783|NCT01579929|"~     The purpose of this study is to test the safety of study drug LDE225 at different dose~     levels. The investigators will be testing three different dose levels and the dose will~     depend on when the patients enters the study and which dose is being tested at that time. At~     the same time, the investigators will also be testing the safety of LDE225 in combination~     with etoposide and cisplatin.~      The investigators also want to learn more about how to manage side effects the patient may~     develop during chemotherapy. Cancer patients may develop side effects during treatment, such~     as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may~     be due to the cancer itself, or due to treatments. Doctors and nurses often ask patients~     about their symptoms, because an important part of cancer treatment is to make patients feel~     as well as possible. If patients do not feel well, the investigators may need to change the~     way they are treating the patients or prescribe therapies that will decrease their symptoms.~      The best way to find out how the patient is feeling is to ask them directly. The~     investigators are interested in developing new ways to ask patients about how they are~     feeling, using the Internet. A special new website called STAR (Symptom Tracking and~     Reporting for Patients) has been developed to help patients record this information, so~     that their doctors and nurses can review it during clinic appointments. This study is~     designed to help us see if STAR is a helpful way for us to keep track of information about~     patients' symptoms and quality of life. The information from STAR is going to be placed on a~     very secure Internet site. This will provide your doctor with all of the information needed~     to determine if this drug combination is safe enough for you and whether to continue it.~   "
112784|NCT01579916|"~     This prospective annual release study was designed to assess the safety of a trivalent~     influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season~     not previously contained in the trivalent intranasal FluMist vaccine.~      Three hundred healthy adults will receive a single dose of vaccine or placebo and will be~     followed for 180 days after study vaccination.~   "
112785|NCT01579903|"~     This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when~     administered as 2 different dose presentations. The first is the current product vials with~     prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.~   "
112786|NCT01579890|"~     This was a compassionate use, open treatment safety study of Pennsaid topical lotion~     (diclofenac) for osteo or rheumatoid arthritis.~   "
112787|NCT01579877|"~     The aims of this study are to investigate the effect of famous herbal formula extract on~     xerostomia, and to determine whether this formula affect various xerostomia-related~     questionnaires, salivary flow rate, residual saliva and salivary tests.~   "
112788|NCT01579864|"~     Myorelaxation is generally used as a part of general anesthesia for interventional rigid~     bronchoscopy. Succinylcholine is most often used because its short duration of action but~     rocuronium can be used since sugammadex permits a rapid and complete reversal of the~     neuromuscular block. The aim of ths study is to compare both agents.~   "
112789|NCT01579851|"~     Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its~     administration could induce signs of recovery despite continuation of anesthetic drugs. The~     goal of the present study is to look is the arte of this event is different according to the~     primary anesthetic agent used.~   "
112790|NCT01579838|"~     The investigators have identified patients with CD59 deficiency that suffers from chronic~     hemolysis and peripheral demyelinating disease. It was shown that complement terminal~     pathway can cause inflammation in the peripheral nervous system. Complement can greatly~     increase the immune attack in the nerves. Eculizumab has already been shown to be effective~     in a rare blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH). Attacks of PNH~     are also mediated through complement. Therefore, the investigators of this study are~     investigating whether by 'turning off' complement in CD59 deficiency, further attacks of~     hemolysis and nerve injury can be avoided and whether the neurological status will~     ameliorate.~   "
112791|NCT01579825|"~     Hypothesis:~      The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who~     receive bicarbonate buffer at the time of polio immunization.~   "
112792|NCT01579812|"~     The primary objective of this study is to determine if metformin administered in combination~     with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube~     cancer will improve recurrence-free survival at 18 months compared to controls.~   "
112793|NCT01579799|"~     This is a pilot dose-finding study, which is performed with a randomized, double-blind,~     3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine~     Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized~     sequence on three different study days in six healthy volunteers. Each study day involves~     the repeated measurement of gastric content volume, gastric secretion volume and intestinal~     fluid volume using MRI before and after intragastric infusion of L-lysine Monohydrate test~     meals. Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and~     urge to defecate will be recorded using a scale from 0-10. In parallel, samples of gastric~     juice to measure intragastric pH and pepsin concentration, samples of venous blood to assess~     blood pH and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin~     plasma concentration and samples of arterialized blood from ear lobe to measure glucose~     blood concentration will be collected~   "
112794|NCT01579786|"~     The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA~     (remifentanil) consumption and post operative pain measured with VAS, italian version Mc~     Gill Questionnaire Pain and drug consumption (acetaminophen daily consumption).~   "
112795|NCT01579773|"~     The purpose of this study is to learn if women gain weight using progestin-only methods of~     contraception and if so, how much. The investigators will look at users of two~     progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC)~     and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to~     that of users of a non-hormonal method, the copper intrauterine device.~      The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition~     will increase more than the copper-IUD users. The investigators will collect body~     composition data using dual-energy x-ray absorptiometry (DEXA), and collect information~     about diet and activity using validated questionnaires.~   "
112800|NCT01579708|"~     Cardiovascular disease continues to be the principal cause of death in the world. At~     present, the risk factors for cardiovascular disease continue to appear at an earlier age~     permitting prevention activities and the promotion of healthy habits to focus on children.~     Numerous studies have shown that these factors can be controlled in children through~     school-based interventions. At the same time, data shows that there is a persistence of~     unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc…) that begin in~     childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy~     lifestyles should begin as early as possible. The SI Program for Preschool Education is an~     intervention that is both school and home based designed to improve the habits, knowledge~     and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and~     Managing Emotions. This intervention will be implemented in children from three to five~     years of age, in their parents and in their teachers. To evaluate the efficacy of this~     intervention, the principal aim of the phase of evaluations is to quantify the behavior~     changes in the three groups/populations mentioned. The evaluation has been designed~     according to the controlled intervention model, in which twenty-four schools from the~     Community of Madrid will be randomized to implement the Program si! for Preschool Education~     or to function as control schools.~   "
112801|NCT01579695|"~     The purpose of this observational, 10-year, prospective cohort study is to assess the~     potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with~     abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.~   "
112802|NCT01579682|"~     Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric~     disorder. The most promising treatment for adolescents with AN is family-based treatment~     (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up.~     Consequently, providing an alternative therapy early in the treatment course for those not~     responding to FBT may enhance overall outcome. This study aims to develop a new treatment -~     Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged~     12-18 years, who do not show an early response to FBT.~   "
112803|NCT01579669|"~     The goal of this proposal is to develop and evaluate patient-centered care tools for~     autistic adults and their primary care providers (PCPs).~   "
112804|NCT01579656|"~     Consumption of whole grains has been heavily endorsed by both government and major health~     agencies, as evidenced in Health Canada's Food Guide, the US Department of Agriculture's~     Food Pyramid, and the Heart and Stroke Foundation's healthy eating guide. Whole grains have~     been championed for their proposed cardioprotective and weight control effects as suggested~     by epidemiological studies. The health benefits of whole grain products may be attributable~     to their nutrient composition, which contains dietary fibre, protein and several essential~     nutrients. There has also been a concurrent increase in seed consumption. Seeds have a~     similar and potentially superior nutritional composition to whole grains and they are rich~     in mammalian lignans and polyunsaturated fats, especially the highly valued omega-3 fatty~     acids. Preliminary studies on seeds have shown that they impart health benefits similar to~     those imparted by whole grains. Consumer choices regarding seed consumption may be based on~     their potential health benefits. Furthermore, they may also be affected by subjective~     sensory factors, such as appearance, taste and pre-conceived perceptions. Therefore, this~     study will compare the health properties of four seeds and their effects on appetite and~     sensory parameters in healthy individuals. These four seeds will be that of flax, poppy and~     sesame, due to their popularity and consumption as well as Salba, which has also recently~     received much attention for its associated health benefits.~   "
112805|NCT01579643|"~     The primary goal of the trial is to determine if laser-assisted lamellar anterior~     keratoplasty (LALAK) will reduce the risks of post-operative complications such as~     adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty~     (PK).~   "
112806|NCT01579630|"~     The study aims to randomize 52 patients with advanced (Stage IV) EGFR mutation negative~     nonsquamous non-small cell lung cancer (NSCLC) who respond (CR/PR/SD) to 4 cycles of~     pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy. In order to achieve~     that, approximately 144 treatment naïve patients with advanced nonsquamous NSCLC need to be~     enrolled from around 6 investigational sites in Taiwan that have expertise in lung cancer~     diagnosis.~   "
112807|NCT01579617|"~     The purpose of this study is to evaluate the efficacy of an online pregnancy prevention~     intervention that was adapted from the evidence based small group intervention SiHLE.~   "
112808|NCT01579604|"~     The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More~     than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss~     of function in the upper extremities.~      Traditionally, patients sustaining a cervical spine injury were followed for 2 years to~     ensure that recovery had stabilized before offering upper extremity reconstruction. This~     type of reconstruction includes active muscle transfer, tendon transfer and joint fusion.~      Patients are most commonly assessed immediately at the time of injury. Muscle testing is~     commonly performed using Medical Research Grading System (MRC).~      Although complete neurologic stabilization may not be complete until 2 years post-injury, in~     the group with initial grade 0 muscle strength after the acute phase of injury, expectations~     of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3~     muscle strength is felt to be the minimum useful functional strength in a muscle group.~      The investigators propose an early nerve reconstruction approach to the tetraplegic patient~     with dysfunction of the upper extremity to augment the available tendon transfers.~      A comparative pilot study is proposed to determine the effectiveness of supinator branch to~     posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury.~     Patient who fits inclusion criteria will be offered the opportunity to be involved in the~     study and reviewed at 6 months from injury. If the patient still has not regained Grade 3~     power in finger or thumb extension, they will be randomized to be in a surgical group or~     non-surgical group.~      If informed consent is obtained, then surgery will be completed between 6-9 months from the~     patient's original cervical spine injury. The patient will be followed at regular intervals~     post-operatively with expectation of 18-24 month follow-up.~      Measures will be used pre and post-operatively for comparison. Measures will include MRC~     muscle grade (EDC), range of motion, DASH, and GRASSP (Kalsi-Ryan, 2011).~   "
112809|NCT01579591|"~     This is a randomized, double-blind, placebo-controlled phase III study involving 160~     patients designed to assess the efficacy of the high potency probiotic preparation VSL#3®~     versus placebo in increasing the pathological major response rate in patients undergoing~     concurrent CT and pelvic RT.~   "
112810|NCT01579578|"~     The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus~     paclitaxel versus paclitaxel alone in patients with metastatic, gastric or~     gastro-oesophageal junction, cancer.~   "
112811|NCT01579565|"~     The purpose of this study is to determine the safety, efficacy and pharmacokinetics of~     OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post~     operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.~   "
112812|NCT01579552|"~     The purpose of this study is to empower women to improve their health in two very important~     areas: breast and heart health. This twelve-month study will compare two methods of~     informing participants about potential health risks and ways to stay healthy.~      The EMPOWER Study has been designed for adult women who were treated for a childhood cancer~     with chest radiation.~   "
112813|NCT01579539|"~     Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye~     disease, is a common orbital disease in adults. Patients with TAO, especially in its active~     phase, often complain about symptoms of ocular surface discomfort, including excess tearing,~     gritty sensation, increased sensitivity to light and foreign-body sensation, which are~     similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete~     blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear~     evaporation, which increases the tear fluid's osmolarity, and results in ocular surface~     damage. The administration of intravenous glucocorticoids can be an effective treatment for~     TAO.~      The rationale of the present study is to assess the effect of intravenously administered~     glucocorticoids on the signs of DES in patients with TAO with new methods such as~     measurement of tear film thickness, tear film osmolarity and scattering of the tear film and~     well established methods for assessment of the severity of DES. Additionally, impression~     cytology and determination of tear cytokines/chemokines will be performed to obtain~     information about inflammatory processes on the ocular surface.~   "
112814|NCT01579526|"~     The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy~     volunteers.~   "
112815|NCT01579513|"~     Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart~     surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent~     inflammatory response secondary to the body's recognition of the abnormal environment of the~     heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney~     function after the heart surgery. This is turn can lead to longer times on the ventilator~     (breathing machine), the need for higher doses of heart medications, a longer stay in the~     intensive care unit and even death. This is particularly true in infants less than one month~     of age due to their size and the immaturity of their organs. The appreciation of the~     post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions~     directed at its reduction. No therapy has been recognized as the standard of care; however~     steroid therapy has been applied most often despite unclear evidence of a benefit. This~     study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.~   "
112816|NCT01579500|"~     The purpose of this study is to determine whether botulinum toxin A is effective in the~     treatment of neuropathic pain in spinal cord injury patients.~   "
112817|NCT01579487|"~     This study is being performed to follow up on subjects who participated in the initial study~     (ZA10-001) in 2010.~   "
112818|NCT01579474|"~     The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24~     weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1~     hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients~   "
112819|NCT01579461|"~     The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with~     mild and moderate hepatic impairment compared to healthy subjects.~   "
112820|NCT01579448|"~     Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection~     over 3 years and data regarding the protective efficacy over five years is anticipated for~     2012. Regardless at the end of five years, it may still be necessary to provide a booster~     dose or reimmunize with two doses to maintain protection in previously immunized~     populations. This study examines the immune protection and safety of providing a one and two~     dose boosting regimen of Shanchol™ given five years after the initial dose.~   "
112821|NCT01579435|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to~     identify the cerebral mechanisms involved in these potential effects.~   "
112822|NCT01579422|"~     The primary aim of this proposal is to develop, refine, manualize and assess the feasibility~     and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for~     individuals with psychosis. The intervention will focus on helping individuals interpret~     social situations, specifically the intentions and feelings of others.~      Study methods include preliminary treatment and manual development based on series of~     uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly~     developed intervention.~   "
112823|NCT01579409|"~     In France, primary cardiovascular and metabolic prevention is supported by the French~     National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).~      The investigators made the hypothesis that, independently of other diseases, the non~     adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction,~     change in microcirculation and in cardiac autonomic system. These changes may exist at~     fasting but also be reinforced after a standardised breakfast.~      The investigators aim is to evaluate arterial stiffness, endothelial function,~     microcirculation and cardiac autonomic system according to PNNS status in a case control~     study.~   "
112824|NCT01579396|"~     A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with~     incidence of systemic inflammatory response syndrome (SIRS) and associated increased risk~     for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase~     the postoperative IL-6/Il-10 ratio.~   "
112825|NCT01579383|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous~     injection.~   "
112826|NCT01579370|"~     Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for~     the prevention of healthcare-associated infections (HAIs) due to selected~     multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large~     prospective, multicenter study enhanced terminal room disinfection to 1) determine the~     efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs~     and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens~     among hospitalized patients.~   "
112827|NCT01579357|"~     The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on~     the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen~     is given combined with Oxaliplatin (OxPt).~   "
112828|NCT01579344|"~     The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid~     carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy~     and metastases. Although serious complications are uncommon after treatment, there are~     well-documented adverse reactions secondary to the involvement of the salivary glands, such~     as dry mouth, pain in the parotid glands and dysphagia, even after administration of low~     doses of radioiodine. However, ocular complications of such treatment are scarcely reported~     in literature.~      Among them the investigators can mention recurrent and chronic conjunctivitis,~     keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive~     iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially~     after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction~     have been reported as complications associated with the use of radioiodine, although studies~     are not available to assess its true incidence through the systematic evaluation of~     patients.~      It can be seen in routine practice that these patients would normally be referred for~     ophthalmological examination only if a complaint, what happens in the process of OVL already~     installed after the use of high doses of radioiodine. With the early evaluation of these~     patients, the investigators focused on detecting the process of ongoing obstruction in order~     to study interventions that prevent its final installation.~   "
112829|NCT01579331|"~     Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular~     pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be~     compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the~     gold standard technique.~   "
112830|NCT01579318|"~     A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor~     activity of intratumoral IL-12 plasmid (i.e., pIL-12) electroporation in subjects with stage~     IB to IIIB mycosis fungoides.~      All subjects may receive up to six cycles of treatment consisting of two treatment days,~     Days 1 and 8, in a 28-day cycle. Patients will receive intra-tumoral injection of pIL-12 at~     a concentration of 0.5mg/ml and a fixed volume of 0.25 mL per each 1.0 cm diameter of target~     region, followed immediately by electrical discharge around the tumor site resulting in~     electroporation of plasmid DNA into tumor cells.~   "
112831|NCT01579305|"~     The purpose of this study is evaluate lip fullness 3 months following treatment with~     Juvéderm® Volbella with Lidocaine or Restylane-L®~   "
112832|NCT01579292|"~     The goals of the study are to:~        1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary~          intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared~          to a control group.~        2. To explore the association between low heath-literacy levels at baseline and adherence~          to mobile phone usage.~        3. To conduct process evaluation to gain insights into patient compliance to the mobile~          intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months~          using a semi-structured interview method.~   "
112833|NCT01579279|"~     To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic~     neuropathic pain. People with diabetes can, over time develop nerve damage throughout the~     body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms,~     feet and legs.~   "
112834|NCT01579266|"~     Background:~      - People with writer s cramp develop tightness in arm muscles and abnormal hand posture when~     writing, which makes writing difficult or impossible. At present, there is no suitable~     rating scale to measure the symptoms of or disability associated with writer s cramp.~     Researchers want to videotape people performing simple writing tasks. They will then compare~     the performance of people with writer s cramp on these tasks to those of people without~     writer s cramp. This information will help develop a rating scale to evaluate writer s~     cramp.~      Objectives:~      - To develop a new rating scale for writer s cramp.~      Eligibility:~      - Individuals at least 18 years of age who have writer s cramp.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have one outpatient study visit that will last about 3 hours.~        -  Participants will perform tasks related to writing, such as writing passages and~          drawing spirals and loops. They will be videotaped during these tasks. They will repeat~          some of the writing tasks three more times; on paper attached to a writing tablet,~          directly on the writing tablet, and on a computer tablet.~        -  The angles made by the joints will be measured at rest not while writing~      healthy volunteers.~   "
112835|NCT01579253|"~     Patients with recurrent glioblastoma who are planned to receive a second course of radiation~     are to be included into this monocentric cohort trial. Due to multiple pre-treatments~     simultaneous combined positron emission tomography (PET) with~     O-(2-[18F]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used~     for treatment planning and follow-up imaging as it allows for a better distinction between~     treatment-related changes and viable tumor tissue.~   "
112836|NCT01579240|"~     This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older~     adults adopt and maintain an exercise regimen. A total of 368 men and women over 55 years of~     age (x = 60.3; SD 4.9 ) were recruited and screened on line. They randomized into treatment~     and control groups and assessed at pre-test, 12 weeks, and at six months.~      The multivariate model was significant at posttest (p = .001; large effect size) and at six~     months (p = .001; medium effect size). At posttest, intervention participation showed~     significant improvement on 13 of 14 outcome measures compared to the control group. At six~     months, treatment group participants were found to maintain large gains compared to the Ctrl~     participants on all 14 measures.~   "
112837|NCT01579227|"~     The following two objectives are proposed in healthy subjects to characterize (1) wound~     closure, (2) scar formation/appearance, and (3) inflammatory response:~      Objective 1, (topical only - referred to as TOP) - Topical application of Tocotrienol~     (TCT) vs placebo in bilateral punch biopsy~      Objective 2, (oral and topical - referred to as OTOP) - Combined oral supplementation and~     topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy~      Objective 3, (topical only - referred to as TAM) - Topical application of tamoxifen vs~     placebo in bilateral punch biopsy.~      Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on~     bilateral lets on normal skin.~   "
112838|NCT01579214|"~     The investigators will study the efficacy of a novel cellular phone messaging system to~     communicate health information and facilitate early return to clinic after abnormal~     laboratory results in rural Uganda.~   "
112841|NCT01579175|"~     The investigators are randomizing patients to receive chewing gum (Extra Sugar Free,~     Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative~     care. The investigators then have them fill out a survey in house and 1 week after their~     surgery that record time to first flatus, hunger, toleration of clear liquids and food and~     some information about pain, satisfaction, and quality of life. The investigators contact~     them via phone and email a maximum of three times in order to collect this information. 30~     days postoperatively the investigators also contact them and perform a chart review for any~     postoperative complications.~   "
112842|NCT01579162|"~     HepQuant tests are new liver tests that are being developed to accurately measure liver~     function with sensitivity and specificity while being safe and non-invasive. The primary~     goal of this study is to define the intra-individual reproducibility of the HepQuant tests,~     that is, to see if a person is given the tests several times that the test results are~     essentially the same each time. Subjects for this study will include healthy controls and~     patients with chronic liver diseases. The chronic liver diseases will include hepatitis C~     virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic~     steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with~     early stage and late stage liver disease as defined by the amount of fibrosis observed in~     their liver biopsies. Once a subject has been enrolled in the study they will be given the~     HepQuant tests on three separate days within the span of one month. The hypothesis of this~     study is that HepQuant tests will reproducibly report liver function in healthy controls and~     patients with all stages of chronic HCV and NASH liver disease and that liver function will~     decrease as the amount of liver fibrosis increases in the chronic liver disease patients.~   "
112843|NCT01579149|"~     The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor~     injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese~     descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be~     enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of~     plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC~     dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled~     first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally~     the highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose~     escalation are met.~   "
112844|NCT01579136|"~     The purpose of this study is to determine if home blood pressure monitors can help decrease~     blood pressure in patients with diabetes at a low income clinic.~   "
112845|NCT01579123|"~     The reason the investigators are doing this study is to compare the results of laser~     atherectomy versus angioplasty with or without the placement of a stent in the artery. A~     stent is a metal tube used to open up narrow arteries in the body.~   "
112846|NCT01579110|"~     The purpose of this study is to determine whether Levamisole plus prednisone can further~     improve the efficacy，extend the remission duration and reduce the dosage of prednisone for~     newly diagnosed warm antibody autoimmune hemolytic anemia.~   "
112847|NCT01579097|"~     The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared~     to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in~     hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or~     contraindicated.~   "
112848|NCT01579084|"~     This study will evaluate the safety and tolerability of AGN-199201 for the treatment of~     erythema associated with rosacea.~   "
112849|NCT01579071|"~     Insufflation is essential procedure to observe the lumen of gastrointestinal tract in~     gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for~     insufflation According to recent clinical studies have shown that carbon dioxide have better~     safe and reduce stomachache than room air when endoscopy and endoscopic procedure is~     performed.~      However, there was still no research data or study in Korea. In this study, the~     investigators will try to make comparison between Carbon dioxide and room air insufflation~     for endoscopic submucosal dissection for Gastric Tumor and investigate the efficacy and~     safety~   "
112850|NCT01579058|"~     Aortic stenosis has been thought to be a degenerative process basically induced by~     long-lasting mechanical stress, and hemodynamic factors such as shear forces, acceleration~     of blood flow, hypertension and rapid heart rate might contribute to progression of aortic~     stenosis. Peak aortic jet velocity is known to be associated with clinical outcomes in mild~     and moderate AS, and our previous study showed that rate of progression was significantly~     associated with baseline aortic jet velocity in mild aortic stenosis. Because beta-blocker~     therapy would decrease aortic jet velocity and heart rate, it might decrease hemodynamic~     stress and eventually slow down the degenerative process in patients whose disease is not~     too advanced for therapy to be effective. The investigators hypothesized that a beta-blocker~     therapy would decrease the rate of progression of aortic stenosis by modifying hemodynamic~     factors favorably in patients with mild to moderate aortic stenosis.~   "
112851|NCT01579045|"~     Primary Hypotheses:~      Senofilcon A will provide significantly less rotation with subjects in a recumbent position~     than Filcon II 3 monthly .~      Etafilcon A will provide significantly less rotation with subjects in a recumbent position~     than Filcon II 3 1 1 day .~      Etafilcon A will provide rotation with subjects a recumbent position non-inferior to~     nelfilcon A. A margin of 5 degrees will be used.~      Secondary Hypotheses:~      Senofilcon A will have significantly better monocular visual performance with subjects in a~     recumbent position than Filcon II 3 monthly.~      Etafilcon A for astigmatism will have significantly better monocular visual performance with~     subjects in a recumbent position than Filcon II 3 1 day.~      Etafilcon A will have monocular visual performance with subjects in a recumbent position~     non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.~   "
112852|NCT01579032|"~     The aims of the presented study are as follows:~        1. To evaluate the endothelial function and arterial stiffness in a large cohort of~          prevalent CKD patients by means of non-invasive applantion tonometry.~        2. To evaluate the association between the serum levels of the representatives of the~          various classes of uremic toxins and markers of endothelial function and arterial~          stiffness.~        3. To evaluate the association between markers of inflammation and oxidative stress and~          markers of endothelial function and arterial stiffness.~        4. To evaluate the association between echocardiographic parameters and markers of~          arterial stiffness~   "
112853|NCT01579019|"~     This randomized, double blind, phase II study will evaluate the efficacy and safety of two~     doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys~     (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease~     inhibitor containing regimen with or without pegylated interferon. Patients will be~     randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice~     daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or~     1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with~     danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and~     Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination~     with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on~     study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.~   "
112854|NCT01579006|"~     This multi-center, observational study will evaluate the clinical practice patterns,~     efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had~     an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with~     one biological agent. Data will be collected from each eligible patient initiated on~     RoActemra/Actemra treatment by their treating physician according to approved label for 6~     months from start of treatment.~   "
112855|NCT01578993|"~     The purpose of this study is to determine the rate and timing of interventions and~     complications related to the use of peripherally inserted central venous catheters in adult~     patients.~   "
112856|NCT01578980|"~     A single arm, single treatment study is proposed to assess the feasibility of the AP~     Platform (cell phone + Control to Range system) outside of a hospital based clinical~     research center.~   "
112857|NCT01578967|"~     The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4~     chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of~     cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In~     addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive~     radiation therapy. The use of chemotherapy and radiation may cause long term treatment~     related side effects such as heart problems and other cancers. Researchers are trying to~     find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD~     chemotherapy cycles given is just as effective as the standard Hodgkin treatment.~      Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for~     the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study,~     the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered~     investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug~     attached to it. Antibodies are proteins that are part of your immune system. They can stick~     to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks~     to a target called CD30. CD30 is an important molecule on some cancer cells and some normal~     cells of the immune system.~      The purpose of this research study is to see the effects of treatment with fewer cycles of~     the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on~     study participants and Hodgkins lymphoma.~   "
112858|NCT01578954|"~     The purpose of this research study is to test the safety of the study drug, lenalidomide, at~     different dose levels in people diagnosed with acute myeloid leukemia (AML) who have~     finished standard induction therapy and have had a partial or complete response to induction~     therapy. The investigators want to find out what effects (for example, side effects) the~     study drug, lenalidomide, has on people and their leukemia. The investigators also want to~     see if additional treatment (maintenance therapy) with lenalidomide will keep the leukemia~     from relapsing (coming back).~   "
112859|NCT01578941|"~     The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg)~     taken at the first onset of menstrual migraine will both terminate the acute headache and~     assist in preventing headache recurrence and the need for repeat abortive therapy over the~     ensuing days of menses.~   "
112860|NCT01578928|"~     The purpose of this study is to assess the effect of renal impairment on the~     pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different~     degrees of renal impairment.~   "
112861|NCT01578915|"~     Both population based surveys and more focused research studies indicate that increased~     numbers of sexual partners and partner concurrency contribute to increased risk for~     acquisition of sexually transmitted infection (STI), including HIV infection. However,~     unlike for men, both national and sub-population-based studies consistently find that the~     great majority of women with or without STIs report only 1-2 sex partners in the preceding~     year and that a minority of women acknowledge > 3 sex partners over the same period,~     suggesting that this relatively small proportion of women with higher numbers of sex~     partners play a disproportionate role in sustaining community STI rates. Despite these~     observations, surprisingly little is known about women with increased numbers of sexual~     partners, the factors which contribute to increased partner number, and the potential for~     those factors to be intervened upon to reduce risk for STI. The implications of these facts~     for STI/HIV prevention efforts are profound. For instance, interventions that include the~     implication that target audiences have multiple sex partners might be dismissed as~     irrelevant by those with single partners. Conversely, interventions targeting women with~     multiple sex partners may be based on assumptions derived from data which, while~     representative of the general target audience, may not reflect relevant circumstances for~     the subset of women with higher numbers of partners.~      This study will begin to generate data that will provide critical information on this topic~     and help inform future development of STI/HIV interventions tailored to womens' individual~     circumstances and contexts. The investigators hypothesize that women with 4 or more sexual~     partners during the past year will report higher rates of depression and substance abuse~     (alcohol and drugs), higher rates of intimate partner violence, less social support, more~     non-vaginal sex, more same-sex contacts, and higher rates of STIs than women reporting only~     one sexual partner during the past year.~   "
112862|NCT01578902|"~     The purpose of this study is to determine the safety and efficacy of a short course of~     radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.~   "
112863|NCT01578889|"~     Some vaccines may work better when given together with another substance known as an~     adjuvant or when given with an experimental procedure called electroporation (EP). EP is a~     method where an electric pulse is administered to the same muscle where the vaccine~     injection is given. The addition of the adjuvant to the vaccine and the delivery with EP may~     increase a person's immune response to the vaccine. Combination approaches such as a DNA~     vaccine followed by live vector boost may also increase a person's immune response to the~     vaccine components. All of these interventions will be tested in this study.~      This study will evaluate the safety and tolerability of and immune response to an HIV DNA~     vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live~     vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.~   "
112864|NCT01578876|"~     The purpose of this study is to determine the effectiveness of cardiac shock wave therapy~     (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.~   "
112865|NCT01578863|"~     The child health and sports center, at the Meir Medical Center, runs for over 10 years an~     intervention program to treat obese children. The program includes physical activity,~     nutritional intervention and behavioral treatment. A similar program exists in the nearby~     city of Hadera. The aim of the programs is to promote weight loss, encourage physical~     activity and modify behavior in order to get long term results. The aim of the present study~     is to try and identify the demographic and behavioral characteristics of children who~     succeed in the program.~   "
112866|NCT01578850|"~     To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly~     plus methotrexate with or without other disease modifying antirheumatic drugs therapy with~     that of methotrexate with or without other disease modifying antirheumatic drugs therapy at~     Week 52 in subjects with moderately to severely active rheumatoid arthritis who have~     achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg~     once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.~   "
112867|NCT01578837|"~     The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind~     randomized placebo controlled trial. The objective is to investigate whether the combination~     of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are~     effective and safe in the long-term management of high blood pressure while managing type 2~     diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key~     inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.~   "
112868|NCT01578824|"~     Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in~     exhaled breath condensate in vitamin D resistant rickets.~      Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy~     and inflammatory mediators in exhaled breath condensate in a prospective study evaluating~     patients with vitamin D resistant rickets and in healthy controls.~      Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as~     assessed by methacholine challenge test.~      Secondary outcome parameters: All other parameters are the secondary end points.~   "
112869|NCT01578811|"~     The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With~     acute and chronic gastritis.~   "
112870|NCT01578798|"~     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and~     adaptive branches of the immune system are affected by surgical trauma. The purpose of this~     study to characterize the cellular and molecular mechanisms immune response to surgical~     trauma. Additionally, detailed information about patients' recovery profile will be recorded~     over a period of 6 weeks, with the eventual goal of linking immune responses to recovery~     profiles.~   "
112871|NCT01578785|"~     This study will investigate the efficacy, safety and tolerability of a new formulation of~     glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with~     Relapsing-Remitting Multiple Sclerosis (RRMS).~   "
112872|NCT01578772|"~     This research study is to see whether blood vessel function, an early sign of heart disease,~     improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators~     will be looking at how a blood vessel in the arm, called the brachial artery, changes in~     response to stress before and after taking telmisartan. To determine how well the blood~     vessel functions, the investigators will be using an ultrasound machine.~      Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat~     blood pressure, but has been shown to improve blood vessel function in HIV-negative people~     with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this~     trial is sponsored by The Campbell Foundation.~   "
112873|NCT01578759|"~     The purpose of this study is to assess the feasibility of performing a randomized clinical~     trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during~     laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes~     can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled~     tubes)and additional invasive procedures such as further imaging work-ups and further~     surgery related to the tubes.~   "
112874|NCT01578746|"~     In total hip arthroplasty several approaches can be used. The newly introduced minimally~     invasive anterior approach is supposed to cause less damage to tendons and muscles. At the~     same time there are reports that there are more complications when this approach is used.~     The direct lateral approach is the most used in Norway and is well documented. There are~     however those who postulate that there is to high risk of damage to the gluteus medius~     causing Trendelenburg gait. In the investigators hospital both the anterior and direct~     lateral approach is used with good result. The investigators main study hypothesis is that~     there is no difference between the use of anterior or direct lateral approach i total hip~     arthroplasty in regards to postoperative function and pain, complications, radiological~     finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.~   "
112875|NCT01578733|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the~     nitrogen balance method have been well described. Importantly, nitrogen balanced~     underestimates requirements.~      The current DRI requirement for healthy adult males is based on the reanalysis of the~     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by~     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and~     0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group~     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2~     g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70~     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which~     represents about 15 % of calories. Depending on the calculations used for ideal body weight~     some older adults could be getting higher or lower than requirement. There is no~     scientifically derived protein estimate for older adults. Therefore there is a need to~     measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of female elderly~     subjects between the ages of 65 - 70 years using the IAAO technique.~   "
112876|NCT01578720|"~     The purpose of this study is to assess the efficacy and safety of intravitreal injection of~     aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed~     ocular histoplasmosis syndrome (POHS).~   "
112877|NCT01578707|"~     The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy~     results in a clinically significant improvement in progression free survival (PFS) as~     compared to treatment with ofatumumab in patients with relapsed or refractory Chronic~     Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)~   "
112878|NCT01578694|"~     Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One~     of the techniques which has shown great promise is the imaging technique called T1ρ~     (T1-rho). T1ρ is a modified pulse sequence from the standard T1 sequence used in the~     clinical MRI. Because the initial phases of arthritis occur at the molecular level, the main~     advantage of the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is~     a molecule that is important to cartilage structure, and is lost as osteoarthritis develops.~     If we can show that this non-invasive tool can accurately assess cartilage damage and levels~     of proteoglycan, the clinical applications are numerous. The results can potentially help~     determine optimal surgical techniques and timing of surgical intervention to halt or slow~     the progression of arthritis, and will assist in the study of the effects of FAI and the~     success of the surgery performed to correct FAI.~   "
112879|NCT01578681|"~     The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.~      Primary objective:~      -To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to~     placebo.~      Secondary objectives:~        -  To evaluate the level of knowledge of airway clearance techniques and adherence to them~          in patients with bronchiectasis.~        -  To assess the side effects during the procedure: oxygen desaturation, increased dyspnea~          and hemoptysis.~   "
112880|NCT01578668|"~     The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are~     effective and safe in treating lung adenocarcinoma with brain metastases.~   "
112881|NCT01578655|"~     This Phase 3 study has been designed to confirm that adding custirsen to~     cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes~     compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate~     resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,~     international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.~     cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal~     probability to the two arms.~   "
112882|NCT01578642|"~     The EndoStim Stimulation System is an investigational device intended to improve the lower~     esophageal sphincter (LES) resting tone and restore LES function in individuals suffering~     with gastroesophageal reflux disease (GERD).~   "
112883|NCT01578629|"~     A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as~     barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and~     lowers cholesterol, which make it a potential therapy for stroke prevention, though these~     effects are less well characterized for TCT. We plan to conduct two trials (I & IIA) to~     determine the effects of orally supplemented TCT on platelet function and cholesterol.~   "
112884|NCT01578616|"~     Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability.~     The high resolution of optical coherence tomography (OCT) provides an accurate measurement~     of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque~     and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive~     automatic and quantitative method to evaluate endothelial function. The investigators will~     investigate the association between endothelial function assessed by RH-PAT and plaque~     vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).~   "
112885|NCT01578603|"~     The purpose of this study is to determine the effect of three times a day mastication,~     during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various~     factors associated with dental caries and gingivitis.~   "
112886|NCT01578590|"~     Rationale: The consumption of dietary protein immediately after exercise is necessary to~     maximally stimulate muscle protein synthesis rates (24, 37). Recent work suggests that the~     type of protein consumed (e.g., animal vs. plant-derived proteins) during post-exercise~     recovery can affect the amplitude of acute increases in muscle protein synthesis rates (25,~     31). Specifically, consumption of bovine milk proteins immediately after a single bout of~     resistance exercise stimulates muscle protein synthesis rates greater than consumption of an~     isonitrogenous soy-protein beverage (31, 37). Importantly, consumption of milk promotes~     greater hypertrophy than soy after resistance training (10). Thus, it is generally assumed~     that the acute muscle protein synthetic response predicts long-term training outcomes, such~     as hypertrophy. Currently, a great amount of work has been carried out to study the effects~     of consuming milk proteins on muscle protein synthesis rates after resistance exercise (5,~     7, 26, 32). However, very little is known about the effects of other types of high-quality~     animal proteins, such as beef, on stimulating post-exercise muscle protein synthesis rates.~     Further describing the muscle protein synthetic response after consumption of other types of~     high-quality animal proteins will provide valuable information for individuals with milk~     allergies, lactose intolerance, or simply a strong dislike of dairy products.~      Objective: To investigate whether the in vivo post-resistance exercise muscle protein~     synthetic response is augmented when minced beef is ingested as compared to an~     isonitrogenous-matched milk protein beverage in healthy young men.~      Study design: Crossover, randomized~      Study population: 12 healthy young males (18-35 y).~      Intervention: Subjects will perform resistance exercise and consume either a piece of meat~     (135 grams, 35 g of protein) or an isonitrogenous-matched milk protein beverage on two~     separate test days. In addition, continuous intravenous tracer infusions will be applied,~     with plasma and muscle samples collected. A two week 'wash-out' period will be included~     between trials.~      Main study parameters/endpoints Primary endpoint: Muscle protein synthetic rate, expressed~     as fractional synthetic rate (FSR). Secondary endpoints: Rate of protein digestion and~     absorption and whole body protein balance.~   "
112887|NCT01578577|"~     Many patients have difficulty performing routine medication management tasks. Individuals~     with limited literacy are at high risk for these problems. The overall study objective is to~     rigorously evaluate two primary care-based medication therapy management strategies that~     leverage an electronic health record (EHR) to promote patient understanding, medication~     reconciliation, medication adherence and disease control among hypertensive patients at~     safety net clinics.~   "
112888|NCT01578564|"~     The purpose of this study is to determine the safety and tolerability of the drug SOR-C13~     when given as an intravenous infusion in patients with ovarian cancer or other cancers known~     to over express the TRPV6 calcium channel.~   "
112889|NCT01578551|"~     To determine the 1 year progression-free survival (PFS) of the combination of metformin and~     standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary~     adenocarcinoma.~   "
112890|NCT01578538|"~     Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective~     complications.~   "
112891|NCT01578525|"~     The purpose of this study is to determine whether additional pharmaceutical care for elderly~     patients (home-cared patients, nursing-home residents) has a positive impact on drug-related~     readmissions.~   "
112894|NCT01578486|"~     This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15~     schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive~     functioning, and metabolic parameters.~      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or~     Massachusetts General Hospital. A total of 15 subjects will be enrolled.~   "
112895|NCT01578473|"~     Two recent studies have identified low levels of serum testosterone in association with~     Peyronie's Disease (PD), with a significant correlation noted between severity of~     testosterone deficiency and severity of curvature. The study hypothesis is to determine~     whether treatment with testosterone may help men with PD and penile curvature.~   "
112896|NCT01578460|"~     Poor glucose control during pregnancy is a significant concern for Canadian women with~     diabetes. This problem is magnified in First Nations women, who have among the highest rates~     of gestational diabetes (GDM) in the world (up to 18% of First Nations women will develop~     GDM during pregnancy and 70% of these will go on to develop type 2 diabetes later).~     Continuous glucose monitoring (CGM) technology has the potential to help women maintain~     tighter control during pregnancy, however, in the First Nations population, there are many~     unique barriers that may affect use of this technology. Such barriers include remoteness of~     the community, cultural apprehension, lack or difficulty of access to care, and language~     differences.~      A total of 60 participants from three participating First Nations communities in Southern~     Ontario will participate in the study. Participants will self-select to either the CGM group~     (n=30) or the control group (n=30) after consenting to participate in the study.~     Participants in both groups will be asked to monitor their blood glucose for 5 days for the~     28th, 32nd and 36th week of gestation. Primary outcomes to be evaluated include maternal A1c~     and offspring birth weight. To assess the feasibility and acceptability of CGMs among First~     Nations women, a questionnaire will be distributed to participants to gather insight into~     their rationale for enrolling into either group. Recruitment rates for both groups will also~     be used to assess feasibility and acceptability of CGMs. Additionally, all participants will~     be encouraged to participate in a community lifestyle program consisting of 30-min exercise~     sessions offered five days a week. The community lifestyle program will be adapted to the~     community, linked to existing programs with support from program personnel and will include~     educational sessions related to diabetes and healthy lifestyles. It is hypothesized that~     through participation in the community lifestyle program, pregnant First Nations women with~     diabetes will experience a decrease in their blood glucose values post-exercise, mitigate~     excessive weight gain and normalize their A1c's. It is further hypothesized that an increase~     in women's regular physical activity levels, the number of steps taken and knowledge of~     diabetes will be observed.~   "
112897|NCT01578447|"~     The purpose of this study is to assess acceptability and side effects of a low-dose~     injectable contraceptive formulation which is delivered under the skin (subcutaneously), as~     compared with injectable contraception delivered into the muscle (intramuscularly) among~     adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable~     contraception. The investigators will also assess experiences experiences delivering these~     two types of injections among health care providers working within the HIV care clinics.~   "
112898|NCT01578434|"~     Rickets, a common nutritional disorder, is usually considered to be due to vitamin D~     deficiency. However, in the last few decades many studies have shown that in tropical~     countries, with abundance of sunshine, calcium deficiency may play a more important role in~     the causation of rickets. Studies from adults in India have also shown that calcium intake~     of our population is much below the recommended allowance. The calcium deficiency gets~     compounded by the high level of phytates in the conventional vegetarian diet consumed by the~     majority of the population. There are few studies on children in India / other Asian~     countries on assessment of dietary calcium intake.~      However, recent studies from many nations of the world have also shown a wide spread~     prevalence of vitamin D deficiency in adolescent and adult population. A study done at our~     own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and~     their infants.~      Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not~     clear what plays a more important role in the etiology of rickets in India or other Asian~     countries.~      The present study is therefore planned with the following objectives:~        1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in~          children with and without rickets.~        2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the~          treatment of nutritional rickets.~   "
112899|NCT01578421|"~     The purpose of the study is to compare clearance and removal rates of phosphate,~     ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during~     post-dilution online hemodiafiltration.~   "
112900|NCT01578408|"~     The purpose of this prospective randomized study is to compare the quality of treatment~     between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip~     Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.~      Our hypothesis is that an uncemented option spares the patient the operative load of the~     cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn~     also perhaps reduces the postoperative cognition strain and improves mobilization~     parameters.~      If the uncemented option has the same excellent fixation in poor bone stock, as in the case~     of these osteopenic fractures, and also has the same good clinical outcome, it would be a~     viable standard option for the treatment of dislocated femoral neck fractures.~   "
112901|NCT01578395|"~     Trial with medicinal products~      Recent studies revealed that radiation-based procedures in patients may lead to DNA~     double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human~     blood lymphocytes have shown a protective effect of antioxidant agents which have been~     described to decrease the number of DNA double-strand breaks.~      This study represents a prospective, double-blinded, randomized, single center, and~     placebo-controlled phase II clinical trial which analyzes the capability of antioxidant~     agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in~     patients undergoing radiation-based cardiac examinations (30 patients with high-dose~     radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without~     radiation exposure).~      A protective effect of antioxidant drugs in patients undergoing radiation-based examinations~     could therefore change patient management and would provide an important clinical impact.~   "
112902|NCT01578382|"~     Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin~     infarction) which occurs in long-term hypertensive subjects.~      Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin~     infarction) which occurs in subjects with end-stage kidney disease or after kidney~     transplantation.~   "
112903|NCT01578369|"~     To investigate the effect of pelvic floor muscle training taught in a general exercise class~     during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.~   "
112977|NCT01577394|"~     The aim of this study is to determine whether saccadic eye movement recording may help in~     the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of~     the disease.~      Study type: Interventional Study design: Intervention Model: Single group assignment Primary~     purpose: Diagnostic~   "
112904|NCT01578356|"~     For primary surgical treatment of prostate cancer the investigators compare the classic open~     surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery~     (RALP). Oncological results are obtained at standard follow-up consultations through~     Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional~     results (continence, potency, quality of life) are obtained through standardised~     questionnaires. Currently the investigators perform all of their prostatectomies in a~     robot-assisted manner. For results of the open surgery the investigators send questionnaires~     to patients who had the operation in the past.~   "
112905|NCT01578343|"~     1. Rationale In mantle cell lymphoma, the conventional chemotherapy achieves only~          temporary responses with a median duration of remissions only from 1 to 2 years.~          Therefore, mantle cell lymphoma is known as one of the B-cell lymphomas with poor~          prognosis. Although the treatment outcome of mantle cell lymphoma has been improved~          since intensive chemotherapy regimens such as HyperCVAD was used, a substantial number~          of patients are still frequently relapsed after chemotherapy. After relapse, most of~          them became refractory to various kinds of salvage treatment. That is why the results~          of most salvage chemotherapy regimens were disappointing. In addition, mantle cell~          lymphoma generally occurs in elderly people. Thus, intensive salvage chemotherapy may~          not be feasible for elderly patients. Therefore, an effective, novel combination~          treatment is urgently needed in relapsed or refractory mantle cell lymphoma patients.~        2. Hypothesis~             -  Vorinostat will produce synergism with a combination treatment regimen~               (Fludarabine, mitoxantrone, dexamethasone, FND) without overlapping toxicity~             -  Vorinostat maintenance treatment will reduce the relapse rate in patients~               ineligible for autologous stem cell transplantation.~        3. Purpose A phase II investigation to determin the effectiveness of vorinostat in~          combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients~          with relapsed or refractory mantle cell lymphomain patients with relapsed or refractory~          mantle cell lymphoma.~   "
112906|NCT01578330|"~     The study will assess the patients' satisfaction of treatment after 12 months treatment with~     fingolimod It also will assess the tolerability profile of fingolimod in a small population.~   "
112907|NCT01578317|"~     Background:~      - Adjuvants are substances included in vaccines that stimulate the immune system and~     increase the body's response to the vaccine. The MF59 adjuvant is used in seasonal flu~     vaccines in Europe. However, it has not been fully tested in the United States. Researchers~     want to test the immune responses of people who receive a bird flu vaccine with or without~     MF59 to better understand how the adjuvant works. This information may help develop better~     flu vaccines.~      Objectives:~      - To compare the healthy immune system responses to bird flu vaccine with or without the~     MF59 adjuvant.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be assigned to one of two groups. Each group will have an initial~          vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the~          same type of vaccine. One group will have the vaccine with MF59; the other group will~          have the vaccine without it.~        -  All participants will have two 36-hour inpatient stays to receive the vaccine. Each~          stay will involve the vaccination, followed by regular and frequent blood draws.~          Participants will be monitored for any signs or symptoms that may be caused by the~          vaccine.~        -  Additional blood samples will be collected 7, 28, 42, and 100 days after the initial~          vaccination....~   "
112908|NCT01578304|"~     To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg~     b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary~     frequency associated with urgency as may occur in patients with overactive bladder.~   "
112909|NCT01578291|"~     Hypothesis: The use of parent education and medical play will be able to reduce patient~     discomfort with potential uncomfortable medical procedures.~      Children that have urinary tract infections and those diagnosed with vesicoureteral reflux~     undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow~     vesicoureteral reflux. For many children and parents this can lead to considerable distress.~     Pre-procedure preparation can potentially reduce anxiety and improve overall experience with~     the procedure.~   "
112910|NCT01578278|"~     This is a clinical study to evaluate the safety and efficacy of a bepotastine~     besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic~     rhinitis (SAR) in subjects with a demonstrated history of Mountain Cedar pollen allergy. The~     primary study objective is to assess the reduction from baseline in averaged morning (AM)~     and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays~     (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate~     nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For~     enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with~     placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day~     with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for~     both nasal and ocular symptoms prior to each dosing.~   "
112911|NCT01578265|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, human subjects.~   "
112912|NCT01578252|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
112933|NCT01577979|"~     In this project, the investigators will develop, implement, and evaluate an adolescent~     vaccination quality improvement program, with the program designed to encourage adolescents~     to visit their usual primary care provider to receive vaccinations and other recommended~     preventive health services. This study will be conducted in different types of primary care~     settings, such as public, private, and managed care clinics serving adolescent patients of~     diverse backgrounds, and will provide important information to help guide future public~     health efforts to achieve high rates of immunization in adolescents.~   "
112934|NCT01577966|"~     The main purpose of this part of the study is to determine the Central Nervous System~     bioavailability of sulfasalazine.~   "
112913|NCT01578239|"~     The purpose of this study is to~        -  compare Progression Free Survival (PFS) after treatment with~          177Lu-DOTA0-Tyr3-Octreotate plus best supportive care (30 mg Octreotide LAR) to~          treatment with high dose (60 mg) Octreotide LAR in patients with inoperable,~          progressive (as determined by Response Evaluation Criteria in Solid Tumors [RECIST]~          Criteria), somatostatin receptor positive, well-differentiated neuroendocrine tumours~          of the small bowel (midgut carcinoid tumours).~        -  compare the Objective Response Rate (ORR) between the two study arms~        -  compare the Overall Survival (OS) between the two study arms~        -  compare the Time to Tumour Progression (TTP) between the two study arms~        -  evaluate the safety and tolerability of 177Lu-DOTA0-Tyr3-Octreotate~        -  evaluate the health related quality of life (QoL) as measured by the European~          Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire~        -  explore the correlation of toxicity outcomes and administered radiation doses corrected~          for body weight and body surface area~        -  explore the correlation of clinical efficacy outcomes with the levels of the biomarkers~          Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine~        -  evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients~        -  explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake~          score~        -  explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase~          (AP)~   "
112914|NCT01578226|"~     Infections are frequent life-threatening events in patients with cirrhosis, occurring at~     least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among~     cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no~     clear-cut clinical and biochemical features are helpful in diagnosing and prognostically~     stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker~     presenting high sensibility and specificity in diagnosing bacterial infections in different~     clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and~     prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.~   "
112915|NCT01578213|"~     The purpose of this study is to assess the capability of the dPCR technique to predict the~     absence of disease relapses after imatinib discontinuation in CML patients with negative~     Q-RT-PCR results for longer than 18 months.~   "
112916|NCT01578200|"~     The purpose of this study is to demonstrate decrease in cardiovascular mortality and~     morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with~     those with Calcium carbonate.~   "
112917|NCT01578187|"~     The purpose of this study is to test label comprehension and usability of the hair removal~     device in 60 male and female participants. The study population will represent the US~     demographic distribution of skin types and will include varying levels of literacy.~   "
112918|NCT01578174|"~     The investigators examined the effect of dexmedetomidine in the management of pain after~     uterine artery embolization.~   "
112919|NCT01578161|"~     After genernal anesthesia using sevoflurane or desflurane, the investigators can observe~     many cases of agiation (over 80%) and despite of no report of long-term complication,~     agitation is a big issue in PACU for doctors and nurses. The investigators use~     dexmedetomidine for prevention of agiation of preschool aged children. The investigators~     expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain~     without any complication like oculocardiac reflex requiring atopine for treatment.~   "
112920|NCT01578148|"~     The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic~     pain, and compare it with standard physical therapy using electrical stimulation on patients~     with chronic pain.~      Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific~     procedure with precise location, duration and intensity of TENS stimulation within the~     general FDA guidelines. The therapy substantially relieves general muscular/tendon pain and~     persistently restores the muscle and tendon function. The surface locations of nociceptors~     at the free nerve ending (i.e., Noxipoints) are focused on in the stimulation therapy.~     Multiple clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such~     stimulation at Noxipoints. An observational study of Noxipoint therapy within the~     FDA-approved use of TENS demonstrated an encouraging 93% success rate in eliminating the~     chronic pain, such as frozen shoulder pain, within 2-3 sessions. It is an order-of-magnitude~     improvement over the non-specific application of TENS and any other modalities in pain~     treatment. A unique neuro-immuno-signaling pathway that implicates the activation of adult~     stem cells, such as satellite cells in muscles, is implicated based on such a high success~     rate.~   "
112921|NCT01578135|"~     This study is conducted in Europe. The aim of the study is to describe the patient~     population and therapeutic practices (study phase I), assess efficacy on growth and adult~     height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II).~   "
112922|NCT01578122|"~     Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal~     deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its~     prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying~     30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely~     to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS~     may be difficult to apply and to wear.~      ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more~     comfortable. This could favor a better compliance.~      CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS~     applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of~     targeted pressure at the ankle~   "
112923|NCT01578109|"~     This pilot clinical trial studies the side effects of sorafenib tosylate before and after~     donor bone marrow transplantation in treating patients with acute myeloid leukemia.~     Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
112924|NCT01578096|"~     The primary aims of this study are to:~        1. Tailor a diabetes stress management intervention for delivery by community health~          workers (CHWs) serving an urban Latino population.~        2. Investigate the efficacy of the stress management intervention on glycemic control.~           Secondary aims of this study are to:~        3. Investigate the efficacy of the stress management intervention on stress hormones,~          psychosocial functioning, and stress-glucose reactivity.~      Study hypothesis:~      A CHW-led group-based diabetes education model enhanced with stress management education~     will improve glycemic control more than CHW-led group-based diabetes education alone.~   "
112925|NCT01578083|"~     The investigators overall research hypothesis is that systemic chemotherapy induces~     structural changes in the white matter of the brain as demonstrated with Diffusion Tensor~     Imaging (DTI) and functional changes in well-defined cortical neural networks as~     demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators~     believe these structural and functional changes are responsible for the cognitive symptoms~     associated with chemotherapy-induced cognitive impairment (CICI).~      The Specific Aim for this study is:~      To assess the impact of chemotherapy on structural white matter as defined by DTI and~     functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer~     survivors with self-reported CICI to breast cancer survivors without CICI.~      Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have~     abnormal structural connections characterized by DTI-defined disruptions in fractional~     anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized~     by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without~     self-reported CICI.~   "
112926|NCT01578070|"~     The purpose of this study is to show that ViscoGel® is safe when administrated alone and as~     an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the~     quantitative and qualitative effect on the immune response.~   "
112927|NCT01578057|"~     The purpose of this research study is to understand if there is any difference in the~     effects of tasimelteon when it is taken alone or in combination with alcohol. This research~     study is also being done to understand if there is any difference in the amount of~     tasimelteon (and its breakdown products) or alcohol in the blood when taken alone or~     together. Finally, the study will also look at the safety and tolerability (how acceptable~     it is) of tasimelteon.~   "
112928|NCT01578044|"~     Atrial fibrillation is common and increases the risk of clotting especially in patients with~     multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant,~     require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed~     anti-coagulation clinics that routinely contact them to remind them about blood draws,~     re-enforce medication adherence, and adjust dosing based on labs.~      Dabigatran, a newly approved medication that may be better for some with atrial fibrillation~     to lower risk of stroke and clotting, has been found to have fewer drug problems and~     eliminates lab monitoring need. Following instructions for taking dabigatran is important~     because it is a twice daily medication requiring monthly refills. Rivaroxaban is a once~     daily, newly approved Factor Xa inhibitor oral medication, prescribed to reduce risk of~     stroke and systemic embolism among patients with atrial fibrillation. Apixaban is a twice~     daily, FDA approved Factor Xa inhibitor oral anticoagulant, prescribed to reduce the risk of~     stroke and blood clots among patients with atrial fibrillation. In a double-blind RCT,~     apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and~     death. Patients on dabigatran, rivaroxaban, and apixaban will not be followed in~     anti-coagulation clinics, therefore will not benefit from the support provided by these~     clinics.~      It's anticipated many patients will be switched to dabigatran, rivaroxaban, or apixaban~     following recent publication of criteria for dabigatran use from the VA National Pharmacy~     Benefits Management Program, providing an opportune time to conduct the proposed adherence~     study. We will conduct qualitative interviews with patients(n~30) and pharmacists(n~20) to~     understand barriers/facilitators to oral anticoagulant adherence. Informed by the findings,~     we will develop and pilot test a multi faceted intervention to improve adherence among~     patients recently started on dabigatran/rivaroxaban/apixaban.~      Specific study aims:~        1. Conduct interviews with a sample of patients (n=30) recently started on dabigatran for~          atrial fibrillation to determine why patients do or don't take medications~        2. Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to~          understand their opinions why patients do or don't take medications~        3. Informed by interviews, develop and test an intervention targeting patients/pharmacists~          to improve adherence to dabigatran/rivaroxaban/apixaban~   "
112929|NCT01578031|"~     The investigators' overall goal is to compare the effect of CPAP treatment on intermediate~     cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea~     (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative~     data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups~     will have comparable improvements in daytime sleepiness, but that the cardiovascular and~     metabolic improvements following CPAP therapy will be decreased in OSA patients with~     increased visceral adipose tissue. The investigators anticipate that, although there will be~     a greater absolute change in markers of sympathetic activity, inflammation and oxidative~     stress in obese compared to lean OSA patients following CPAP treatment, the levels will~     still be abnormally high in the obese patients resulting in the decreased improvements in~     insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA~     patients.~   "
112930|NCT01578018|"~     DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem~     cells in colonic crypts. Mutations within the stem cell population are thought to be~     responsible for the development of most colorectal carcinomas and studies have shown that~     DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development~     of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung~     cancers.~      The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with~     suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking~     status.~   "
112931|NCT01578005|"~     Coronary angioplasty is rather frequently performed in such situations, presumably because,~     changes in the atherosclerotic plaque under drug treatment, have remained poorly described~     so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma,~     better than the one provided by coronary angiography.~   "
112932|NCT01577992|"~     Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by~     autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P~     subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad~     because it ended with the patient's death few years later. No neuroprotective treatment has~     shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful~     sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest~     the implication of dopamine neuromediator pathway in integration and modulation of pain.~     Several studies suggest the existence of various influences with dopamine implication in the~     appearance of painful sensation and that would be inhibitory. That's why observed painful~     symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to~     a lost of control of sensitizes centres, to Parkinson control.~      It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold~     and to characterise the levodopa effect on the patient's pain threshold. Better~     physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care.~     Because the efficacy of others treatments is low, it's important to improve the research for~     a better comfort of patients with a better understanding, analysing and treating of the~     pain.~   "
112947|NCT01577797|"~     This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for~     methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based~     short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.~   "
112935|NCT01577953|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need~     for novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product~     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the~     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).~      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic~     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and~     thereby reduces key features of allergic airway inflammation. DNAzymes are generated~     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)~     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by~     use of any living organism including cell culture or bacteria. The molecules are highly~     water-soluble and will be applied as solution directly in their synthesized form.~      The current study will evaluate the safety and tolerability of increasing single doses of~     inhaled SB010 in male patients with asthma who have airway hyperresponsiveness(demonstrated~     by methacholine bronchial challenge test).~   "
112936|NCT01577940|"~     The purpose of this method study in healthy volunteers is to determine the extent of sensory~     block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of~     ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of~     the TAP block and the influence on the lung function.~   "
112937|NCT01577927|"~     Patients at high complexity with severe chronic diseases can require several admission in~     intensive care units (ICU) to overcome acute exacerbations by the use of assisted~     ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of~     patients often needing weaning procedures due to a long-lasting period of mechanical~     ventilation. These patients are often under chronic conditions with recurrent symptoms,~     reduced effort tolerance and depression.~      Weaning process is a frail step in the medical history of a patient who has survived an~     acute episode of respiratory failure and has spent a period of time under mechanical~     ventilation. Patients are followed for the duration of in-hospital stay, an expected average~     period of 4 weeks.~      When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is~     usually managed by GPs and by the hospital where he has been admitted to following~     re-exacerbations. The conventional approach is for sure inadequate for this type of patient~     whose clinical complexity, disability and frailty need for a continuity of care through a~     higher complex approach of management.~      A structured program of Home Rehabilitation could be a possible solution to this problem.~     Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy~     of a home rehabilitative network for prolonged weaned patients discharged from a weaning~     unit.~   "
112938|NCT01577914|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
112939|NCT01577901|"~     Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue~     Advanced Pregnancy test, following the instructions for use. The test will be conducted~     following both the instructions for the in stream method of sampling and the method of~     testing when a sample is collected into a container. The results will be compared to those~     achieved by the study technician.~   "
112940|NCT01577888|"~     To study the early safety and performance of the Shockwave Medical System in subjects to~     demonstrate that the device can safely and effectively deliver localized energy for the~     treatment of vascular disease.~   "
112941|NCT01577875|"~     The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow~     band imaging.~   "
112942|NCT01577862|"~     Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with~     high lethality in hospitalised critically ill patients. It can acquire resistance to all~     classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may~     be the only therapeutic option. However, colistin is not registered for this indication. The~     addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be~     promising in vivo, but this combination has not been studied in comparison with colistin~     alone.~      The purpose of this randomised, open-label, multicentre clinical trial is to assess whether~     the association of colistin and rifampicin reduces significantly the mortality of patients~     with severe MDR A. baumannii infections compared with colistin alone.~      The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care~     hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be~     randomly allocated to either colistin alone (control arm) or colistin plus rifampicin~     (experimental arm).~      Primary end point is overall mortality, defined as death occurring within 30 days from~     randomisation.~      Secondary end points will be disease-specific death, microbiological eradication,~     hospitalization length, emergence of resistance to colistin during treatment.~   "
112943|NCT01577849|"~     The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206~     (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU~     Vitamin D3 , qd) after oral administration in healthy adult volunteers.~   "
112944|NCT01577836|"~     The main objective of the study is to estimate and compare the overall cost of care of~     patients over 24 months of follow-up between two groups: (1) patients undergoing~     robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients~     undergoing robot-assisted radical prostatectomy via laparotomy.~   "
112945|NCT01577823|"~     A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical~     patients receiving spinal anesthesia. Study will track clinical outcomes, patient~     satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary~     tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden~     without increasing postoperative urinary retention (POUR) incidence.~   "
112946|NCT01577810|"~     It is routine practice for a cardiologist to perform a battery of tests to assess the degree~     of heart failure. The purpose of this study is to establish a non-invasive method to~     reliably predict cardiac output state in real-time in children and adolescents with heart~     failure in an outpatient setting. This study will rely on the use of near infrared~     spectroscopy monitors to measure cardiac output in the outpatient setting.~   "
112948|NCT01577784|"~     The principal aim of the study is to determine the objective response rate that offers the~     second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that~     have progressed or that have not tolerated the first line of treatment with a Tyrosine~     Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment~     safety profile for these patients in second-line treatment with pazopanib. The exploratory~     aim is to determine the correlation between biomarkers in patient blood and tumor samples,~     and the clinical results obtained with pazopanib.~   "
112949|NCT01577771|"~     This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal~     conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso.~     Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and~     9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be~     assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age~     will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart.~     Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later.~     Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA~     assessments pre-vaccination and 1 month post-vaccination.~      The immunogenicity and reactogenicity of PCV13 in the standard schedule groups (e.g. 6,~     10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in~     the PCV13 licensure trials. Within each age group the alternative schedule will be compared~     to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage~     (infants only).~   "
112950|NCT01577758|"~     This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in~     Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.~   "
112951|NCT01577745|"~     This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation~     (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity~     of MEDI0639.~   "
112952|NCT01577732|"~     This study aims to evaluate the safety and reactogenicity of a booster dose of~     Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age~     who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within~     their first six months of lives.~   "
112953|NCT01577719|"~     People who originate from the Indian subcontinent known as South Asians are the fastest~     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,~     type 2 diabetes and heart disease. They also develop these risk factors at significantly~     lower body weight and at younger ages compared to people of European origin. The purpose of~     SAHARA (South Asian HeArt Risk Assessment) Pilot, is to recruit 400 South Asians from~     Ontario, who use the internet, email and other multimedia devices. Among these participants~     the investigators will compare the effectiveness of a 6-month interactive multi-media health~     behaviour intervention to usual care in reducing cardiac risk factors. This intervention~     enables participants to set their health goals and provides health messaging and feedback~     designed to improve their smoking, dietary habits and physical activity. In addition, the~     investigators will test if knowledge of genetic risk for heart attack influences behaviour~     change and their heart health risk factor profile. The information generated from SAHARA~     will enable individuals, physicians, health professionals, and policy makers to develop risk~     factor modification programs to prevent cardiovascular disease in this high-risk group.~   "
112954|NCT01577706|"~     An advanced technique for rapid magnetic resonance proton spectroscopic imaging (1H-MRSI)~     will be employed in a drug challenge study in healthy volunteers to spatially map and~     measure acute changes in the brain chemicals GABA, glutamate and glutamine after~     administration of a drug. Three condition will be tested in a double-blind fashion,~     i)depressant, ii)stimulant, iii)placebo. It is hypothesized that unique and reproducible~     spatial and directional metabolic response patterns will be observed, unique to each~     condition within the brain.~   "
112955|NCT01577693|"~     The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel~     formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted~     healthy male subjects.~   "
112956|NCT01577680|"~     This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol~     combination in healthy subjects and subjects with moderate hepatic impairment. The results~     of this study will provide guidance on the use of the product in patients with hepatic~     impairment.~   "
112957|NCT01577667|"~     Partial automation of mechanical ventilation in resuscitation has been available for several~     years. New modalities are being developed to completely automate ventilation and oxygenation~     parameters (IntelliVent®.~      This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus~     a conventional ventilation modality.~   "
112958|NCT01577654|"~     This study will test the activity of single-agent EC145 and the combination of EC145 plus~     docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer~     (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants~     of the lung) in participants with all target lesions expressing the folate receptor~     [FR(++)].~   "
112959|NCT01577628|"~     There is a lack of prospective scientific data on the regular use of moisturizers in~     patients at risk of developing atopic dermatitis. Although generally accepted and widely~     used for secondary prevention, emollients have not been studied as a primary prevention~     strategy. Strategies previously studied for the prevention of atopic dermatitis include~     maternal and child's dietary manipulations, allergens avoidance, delay of food introduction,~     exclusive breastfeeding and probiotic supplementation. Despite years of research, none of~     those strategies yielded to strong evidence of a protective effect. There is therefore a~     need to explore novel strategies.~      There is a need to compare the cumulative incidence rate of atopic dermatitis in newborns~     using a standard bathing and moisturizing routine with a good moisturizer to a non~     interventional group.~      This 2-year study will recruit approximately four hundred and sixty (460) pregnant women~     with a first degree relative of the child to be born who currently has (or previously had) a~     diagnosis of atopic dermatitis in order to study approximately 200 eligible newborns in each~     of the two study groups at the beginning of the study.~      Pregnant women will be randomized (1:1) to either daily use of the moisturizer Lipikar Balm~     AP (applied to their infant) starting from birth (Group 1) immediately after bathing or to~     no intervention (Group 2).~   "
112960|NCT01577615|"~     The PEPI study is designed to provide a patterned feeding experience. By using a regularly~     occurring and necessary caregiving event, feeding, as the vehicle for the patterned~     experience, the intervention should be effective at promoting and reinforcing neuronal~     growth and connections that are critical for neurobehavioral and cognitive function while at~     the same time being cost effective in its delivery.~   "
112961|NCT01577602|"~     The purpose of this study is to determine if two basic medical office visit interventions~     improve the agreement of medication lists between electronic medical record and patient~     self, home-based report. The interventions are:~        -  giving patients a printed list of medications before the visit~        -  asking the patients about their medications with a scripted, open ended question.~   "
112962|NCT01577589|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     Ceftaroline 600 mg when administered by varying infusion volumes.~   "
112963|NCT01577576|"~     The main objective of this study is to obtain data for the integrated analysis of~     morphological, functional and biomechanical parameters pertaining to lower limb arteries in~     various categories of elite athletes (without cardiovascular risk and practicing high- or~     low-impact aerobic activities which preferentially implicate lower limb activity) as~     compared to (each other and to) sedentary controls.~   "
112964|NCT01577563|"~     RATIONAL is a multinational, multicentre, observational, cross sectional study of adult~     patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before~     study visit (at least one dose).~   "
112965|NCT01577550|"~     Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to~     severe psoriasis.~   "
112966|NCT01577537|"~     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to~     placebo gel for the treatment of bacterial vaginosis (BV).~      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or~     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime~     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and~     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day~     9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure,~     TOC, Day 21-30).~   "
112967|NCT01577524|"~     The purpose of the study is to determine whether diluted Povidone Iodine solution used to~     irrigate surgical wounds during spine surgery decreases the incidence of surgical site~     infections.~   "
112968|NCT01577511|"~     The main objective of this study is to identify and characterize subpopulations of cells~     with invasive capacity in colorectal cancer from primary tumor, blood and metastatic~     samples.~   "
112969|NCT01577498|"~     Economic globalisation has been associated with a rise of cross-border migration in Europe.~     In France, courts commonly demand appropriate medical tests aimed at age estimations of~     supposed minors without documentation. Determining the age of foreign adolescents may be~     important in order to define the rights and protection afforded them by law depending on~     this status, and the conditions in which they may be detained or held in police custody if~     they are under suspicion. Age estimation is considered to be ideally based on the~     combination of clinical, skeletal, and dental examinations. A number of forensic physicians~     do not integrate published recommendations or the results of published studies into their~     daily practice. Previous studies have shown that medical practice is heterogeneous in this~     area. Factors determining this heterogeneity are unknown.~      We hypothesize that the personal and professional development of the physician, as well as~     the characteristics and the circumstances of medical examination can affect medical response~     on age determination, beyond clinical and radiological data. The purpose of this study is to~     identify factors determining medical response to courts.~   "
112970|NCT01577485|"~     We want to study the effect of short-term consumption of probiotics (a mixture of L.~     rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.~   "
112971|NCT01577472|"~     The aim of this study is to assess the oocyte yield of infertile women with suspected or~     known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with~     Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC~     (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT~     has been conducted to compare the reproductive outcome of patients with POR as defined by~     the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH~     antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo.~     We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to~     an additional increment of endogenous GT thus increasing the oocytes yield after controlled~     ovarian stimulation due to higher endogenous gonadotropin secretion.~   "
112972|NCT01577459|"~     This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the~     pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult~     volunteers.~   "
112973|NCT01577446|"~     Current recommendations require a QRS duration of ≥120ms as a condition for prescribing~     cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that~     patients with heart failure of ischemic origin, current indications for defibrillator~     implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical~     dyssynchrony.~   "
112974|NCT01577433|"~     The purpose of this observational registry is to determine the freedom from driveline (DL)~     infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone~     portion of the DL is externalized resulting in a silicone skin interface (SSI)~   "
112975|NCT01577420|"~     The aim of this study is to test a complementary therapy intervention (reflexology) that~     will assist in improving quality of life (QOL) for women undergoing chemotherapy for late~     stage (III or IV) breast cancer within the context of conventional medical care. Quality of~     life will be assessed via intermediate indicators: 1) physical indicators (greater physical~     functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality,~     lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of~     life.~   "
112976|NCT01577407|"~     The purpose of this protocol is to test the effects of the non opioid nefopam on~     experimental dyspnea and on the counterirritation (ie inhibition of one pain by another~     pain) induced by dyspnea in healthy subjects.~   "
112979|NCT01577368|"~     The main objective is to verify that the administration of piperacillin / tazobactam~     administered by continuous infusion to treat complicated infections or with known or~     suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30%~     higher dose administered in conventional short infusion.~      The secondary objectives were compared between the following variables:~        -  Microbiological response at 3 days of starting treatment~        -  Time to microbiological cure~        -  Clinical response at 3 days of starting treatment~        -  Time to achieve defervescence~        -  To examine the relationship between pharmacokinetic variables and parameters of~          efficacy and safety~        -  To test the hypothesis that continuous infusion maintains adequate plasma drug levels~          compared with levels achieved with intermittent administration.~        -  Cost-effectiveness analysis~        -  Occurrence of adverse effects~      To this end, we designed a multicenter, randomized, controlled, double blind, comparing both~     forms of administration in patients with complicated or nosocomial infection with or without~     isolation of Pseudomonas aeruginosa.~      Patients who are candidates for inclusion are classified according to APACHE II and to have~     or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive~     piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as~     the ultimate effectiveness of treatment and other variables such as high efficiency, safety,~     pharmacokinetic and pharmacoeconomic.~   "
112980|NCT01577355|"~     This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the~     absorption, distribution, metabolism and excretion of LY2784544. This study is for research~     purposes only and is not intended to treat any medical condition.~   "
112981|NCT01577342|"~     Ranibizumab (Lucentis) is currently the best treatment for wet Age-Related Macular~     Degeneration (AMD). To work, the drug must be injected by means of an intravitreal injection~     (IVT) into the vitreous (jelly-like material) cavity in the back of the eye, repeatedly at~     intervals ranging from one to several months. Endophthalmitis is a rare but devastating~     infection of the eye that occurs in approximately 0.2% of patients after IVT injection. Many~     ophthalmologists ask patients to use antibiotic eye drops after IVT injection in the hope~     that this may reduce the risk of endophthalmitis. There is no proof that this happens and~     there is a possible risk that repeated exposure to the same antibiotic may cause antibiotic~     resistance organisms (bacteria) to develop over time.~      The investigators hypothesize that repeated exposure to antibiotic during the initial stages~     of treatment for AMD will result in a progressive shift in the conjunctival flora with an~     increasing number of antibiotic resistant organisms appearing over time. If this is~     demonstrated, changes to the prevailing treatment approach will be needed to reduce the long~     term risk of a patient developing antibiotic resistant endophthalmitis during treatment.~   "
112982|NCT01577329|"~     The purpose of this study is to assess the feasibility and potential impact of an eight week~     program of meditation on expiratory time, anxiety and dyspnea in people with COPD.~   "
112983|NCT01577316|"~     The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine~     (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to~     15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.~   "
112984|NCT01577303|"~     The purpose of this study is to determine whether different internet-based treatment~     programs, consisting of cognitive bias modification, reduce symptoms of social phobia among~     a population diagnosed with this disorder.~   "
112985|NCT01577290|"~     The purpose of this study is to examine the effects of a 10 week mindfulness training~     program -- without therapist-support -- as treatment of anxiety. Effects on depression,~     quality of life, and insomnia symptoms will also be studied.~   "
112986|NCT01577277|"~     The present study is based on cross-sectional data from the baseline investigations carried~     out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary~     schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th~     grades (8-12 year olds) took part in these baseline investigations of socioeconomic status,~     pubertal status, growth status, learning abilities, well-being, sleep, physical activity and~     risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.~   "
112987|NCT01577264|"~     This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated~     with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.~   "
112988|NCT01577251|"~     The goal of this study is two-fold: to establish a tissue banking respository (defined as~     blood, urine, soft tissue, tumor specimen, and normal tissue from areas surrounding tumor~     specimens), and to prospectively assess health related quality of life (QOL) over time in~     patients with a pathologically confirmed diagnosis of neoplasia receiving radiotherapy or~     photodynamic therapy (PDT)~   "
112989|NCT01577238|"~     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to~     placebo gel for the treatment of bacterial vaginosis (BV).~      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or~     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime~     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and~     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day~     9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure,~     TOC, Day 21-30).~   "
112990|NCT01577225|"~     OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact~     layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial~     barrier and is coated with a water-based adhesive. The comparator is a standard care~     treatment regime comprising tape and gauze.~      This study requires 100 eligible patients which will be recruited from the patients~     routinely see by the study investigators at each study site. Eligible patients will undergo~     surgery that results in a surgical wound of 27cm or less that is expected to have low or~     moderate levels of exudate and will have received at least one randomised study treatment.~     The primary objective is to compare OPOV and tape/gauze in terms of wear time per patient.~   "
112991|NCT01577212|"~     The aim of this present study is to test the feasibility and toxicity of individualized~     hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has~     favorable results, a phase II/III trial on maximally tolerable, individualized,~     hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.~   "
112992|NCT01577199|"~     The purpose of this study is compare two commonly-used medication protocols ( low-dose~     clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with~     diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF.~     This research is being done because we do not know if these two medication protocols are~     equally likely to help a woman become pregnant.~   "
112993|NCT01577186|"~     The purpose of this study is to explore the relationship between achieving symptomatic~     remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS),~     and personal and social functioning by means of the Personal and Social Performance (PSP)~     scale in participants treated with flexibly dosed paliperidone ER.~   "
112994|NCT01577173|"~     This phase II, open-label, randomized study will evaluate the efficacy and safety of~     MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of~     the head and neck who have progressed during or following platinum-based chemotherapy.~     Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2~     weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients~     treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation~     of progressive disease and upon meeting eligibility criteria. Anticipated time on study~     treatment is until disease progression or intolerable toxicity occurs.~   "
112995|NCT01577160|"~     The purpose of this study is to evaluate the effectiveness of paliperidone ER for the~     treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability,~     detachment from reality, often with delusions and hallucinations, and withdrawal into the~     self) participants.~   "
112996|NCT01577147|"~     Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation~     prediction products to help identify their most fertile time and aid conception. Volunteers~     will provide SPD with a daily urine sample throughout the study period, which will be used~     for the development and validation of SPD products related to pregnancy and fertility.~   "
112997|NCT01577134|"~     PREFER II aims at developing psychological targeted theory- and evidence-based intervention~     components, which support older people with multiple illnesses in performing more physical~     activity. Many studies provide evidence for the importance of physical activity as a central~     mediator of health. This means that determinants of physical activity such as personal~     resources constitute an ideal target for interventions.~      Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning~     and self-monitoring will be targeted in the interventions. These factors are important both~     for motivating older people with multiple illnesses to change their health behaviors and to~     translate such motivation into behavior.~   "
112998|NCT01577121|"~     To demonstrate if indomethacin associated to conventional treatment for preterm labor is~     useful to delay delivery and to improve neonatal morbimortality in women with preterm labor~     with high risk of intraamniotic inflammation~   "
112999|NCT01577108|"~     The purpose of this study is to examine whether daily use of oral gelatin capsules~     containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can~     reduce the GBS colonization rate of vagina and rectum in pregnant women who present with~     GBS-positive diagnosed by GBS culture at 35-37 weeks gestation.~      This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS~     screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our~     out-patient department. Subjects with vagina and rectum GBS colonization are invited to~     participate in our study after informed consent. A total of 200 pregnant women will~     participate in the study during the 12-months trial period. They are randomly assigned to~     one of the two groups. The study group is treated with two oral capsules of probiotics once~     daily (before sleeping) for 14 days, and the control group will take 2 capsules of placebos.~     Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All~     participators will treated according to GBS guideline by CDC in 2002 during laboring.~   "
113000|NCT01577095|"~     Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined~     therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo~     controlled clinical trial was used.~      Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the~     eligibility criteria were recruited and received various allocated interventions. They were~     randomly assigned into two groups, the control group (TZD, N=15) and the experimental group~     (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels~     together with their homeostasis model assessment (HOMA) indices were statistically assessed~     between before and after treatment. Hypoglycemic activity (%) was also compared between~     these two groups.~      Expecting Results: This study will compare the hypoglycemic activity and the ability of~     improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of~     the plasma FFA concentration will be investigated.~   "
113001|NCT01577082|"~     The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA~     pMDI in terms of lung function considering change from baseline to the entire treatment~     period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled~     on high doses of ICS or on medium dose of ICS+LABA.~   "
113002|NCT01577069|"~     The purpose of the study is to~      1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS)~     technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected~     patients under/after Telaprevir treatment.~   "
113003|NCT01577056|"~     The purpose of this study is to determine whether fish oil supplementation is effective in~     the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.~   "
113004|NCT01577043|"~     The purpose of this study is to determine the effect of racecadotril in acute watery~     diarrhea in children. The investigators will evaluate the effect of product versus placebo.~   "
113038|NCT01576601|"~     The purpose of this prospective, clinical observational trial is to assess the incidence of~     pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics,~     methods of analgesic delivery, and patient/parent satisfaction in patients undergoing~     craniotomy surgery at three major children's hospitals (Boston Children's Hospital,~     Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the~     United States.~   "
113039|NCT01576588|"~     The study will test the efficacy rituximab in addition to glucocorticoids for the treatment~     of B-CLL in elderly or unfit patients.~   "
113005|NCT01577030|"~     Elevated systolic blood pressure is by far the largest single contributor to cardiovascular~     risks in middle-aged and older adults. Lifestyle modifications, including dietary~     modifications, are the first line approach for treating and preventing hypertension. The~     general aim of the proposed study is to address the efficacy of conventional dairy products~     as part of the normal routine diet for lowing arterial blood pressure in middle-aged and~     older adults with elevated blood pressure. The investigators hypothesize that the dietary~     intervention including dairy products will induce significant decreases in arterial blood~     pressure in this population. A secondary aim will be to test the hypothesis that these~     reductions in systolic blood pressure will be associated with increases in arterial~     stiffness/compliance and endothelial vasodilatory function.~   "
113006|NCT01577017|"~     As both medications i.e. CC and letrozole have been shown to be effective in inducing~     ovulation in PCOS patients, this study was performed in order to evaluate which regime~     (whether CC or letrozole) is the best to be used as the first line treatment for PCOS~     patients with infertility for local population. The best regime will therefore could be~     included in the protocol of management of infertility patients with PCOS so that the quality~     of patients' care could be improved.~   "
113007|NCT01577004|"~     BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of~     apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's~     disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption~     of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD,~     pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is~     actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also~     not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and~     DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4~     carriers was half that seen in non-carriers.~      HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as~     EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will~     improve cognitive performance but only in non-carriers of ApoE4.~      OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters~     incorporation of 13C-DHA into plasma lipids or its beta-oxidation.~      ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better~     cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or~     DHA.~      EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA~     metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n =~     20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of~     50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated~     monthly during the supplementation period. Cognitive testing was performed before and 4~     months after starting the omega-3 fatty acid supplement.~      IMPLICATIONS: This project will help explain the apparent link that is newly emerging~     between ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive~     decline, and should help in the development of nutraceutical-based clinical trials using~     fish oil for the elderly.~   "
113008|NCT01576991|"~     The purpose of the study is to describe the relationship between leukocyte, granulose cell~     and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of~     oocyte spindles and their frequency in the eggs from older women and associations with~     aneuploidy.~   "
113009|NCT01576978|"~     The aim of this study is to identify evaluate the effectiveness of stretching exercises of~     Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia.~     -There will be a randomized clinical trial with 60 pregnant women with these symptoms. They~     will be randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga~     for ten weeks, once a week group B postural follow the guidelines recommended for the~     treatment of these pains, for ten weeks. Will be used as a technique for evaluating the~     Visual Analogue Scale to measure pain intensity and confirmation tests of the lumbar and~     posterior pelvic pain in order to differentiate them. A descriptive statistical analysis of~     univariate and bivariate distributions will be made through frequency and graphical~     representation. The association between the variables will be tested by statistical tests:~     [chi-square (X ²)], Fisher's exact test, Student's t test or Mann-Whitney, [Student's t test~     to compare means], ANOVA for the analysis of effects between the groups. [The significance~     level is predetermined to 5%]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from~     the database created .~   "
113010|NCT01576965|"~     The purpose of this study is to learn about bowel preparation (cleansing) before~     laparoscopic hysterectomy and/or sacrocolpopexy. We are most interested in the ability of~     the surgeon to view necessary anatomy for the surgery, which will be assessed by a~     questionnaire completed at the end of your operation by the surgeon. We hypothesize that~     bowel preparation before laparoscopic hysterectomy will result in improved ability of the~     surgeon to view necessary anatomy for the surgery.~   "
113011|NCT01576952|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of~     topical administration of ISV-303 compared with DuraSite Vehicle.~   "
113012|NCT01576939|"~     The main objective of this study is to determine the feasibility of optimizing the IMRT~     treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the~     dental fillings to reduce such dose to < 35 Gy without compromising tumor coverage and/or~     increasing the dose to the remaining oral cavity or nearby parotid glands.~   "
113013|NCT01576926|"~     Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation~     stylopharyngeal muscle.~   "
113014|NCT01576913|"~     Study hypothesis: Music pacing improves the quality of exercise testing in children.~      Children tend to cycle in a non-constant pace during exercise testing, which might make the~     test less reliable.~      20 boys will perform two exercise tests on a cycle ergometer. One test will be done with~     constant tempoed music, and the other without. Different parameters will be checked~     including pedaling cadence, aerobic fitness, level of work load obtained.~   "
113015|NCT01576900|"~     In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better~     outcomes.~      Systemic video instruction might prove to be beneficial by helping patients have better~     understanding on treatment and replacing healthcare personnel.~   "
113016|NCT01576887|"~     This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl~     treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus~     (T2DM) on peritoneal dialysis.~   "
113040|NCT01576575|"~     The purpose of this study is to determine how people absorb and break down (metabolize) and~     eliminate buprenorphine and if CYP3A is involved.~   "
113041|NCT01576562|"~     The purpose of this research study is to test the function of a subjects implantable~     cardioverter defibrillator (ICD) function throughout the duration of their heart surgery.~     ICD function can be altered during some types of heart surgery such as those when a pump~     (ventricular assist device - VAD) is implanted. The investigators would like to study the~     mechanism of device and ICD malfunction.~   "
113017|NCT01576874|"~     The purpose of this study is to determine the impact of gender and hormones (estradiol,~     progesterone, testosterone and cortisol) on responses to stress and smoking cues presented~     in daily, real-world cue presentations compared to a final cue session in a lab. In~     addition, the study will examine the impact of a single dose of oxytocin (chemical produced~     in the body) versus placebo (inactive substance) on stress in males and females.~      This study involves a cue presentation technology known as CREMA (Cue Reactivity Ecologic~     Momentary Assessment) which delivers four daily cue presentations to you on a handheld~     device during your everyday routine. Additionally, the study involves daily collection of~     saliva samples for hormonal testing. These daily procedures will provide information about~     the role of cues and hormones in daily life.~   "
113018|NCT01576861|"~     After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients~     With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the~     investigators wanted to collect data about the long-term efficacy and safety of this kind of~     therapy.~   "
113019|NCT01576848|"~     Rationale: Age related muscle loss (sarcopenia) is assumed to be related to the impaired~     postprandial muscle protein synthetic response to protein and/or amino acid administration~     in the elderly vs the young. Co-ingestion of carbohydrate increases post-prandial insulin~     secretion. Insulin affects skeletal muscle blood flow and may therefore affect substrate~     availability and postprandial muscle protein synthesis. However, it is unclear whether the~     response to the combined intake of protein and carbohydrates is different in elderly~     compared to young subjects.~      Hypothesis: Adding carbohydrate to a bolus of protein represents an effective strategy to~     overcome the impaired postprandial muscle protein synthesis in the elderly.~      Objective: The primary objective of the study is to investigate whether carbohydrate~     co-ingestion augments the in vivo postprandial muscle protein synthetic response after~     protein ingestion and whether this response is different between young and elderly subjects.~     The secondary objective of the study is to assess the effect of carbohydrate co-ingestion on~     insulin levels and microvascular perfusion in young and elderly subjects.~      Intervention: The intervention consists of a single test day during which the subjects will~     receive a drink containing 20 gram intrinsically labelled casein with or without 60 gram~     carbohydrates. In addition, continuous intravenous tracer infusions of labeled amino acids~     will be administered. During the test day 18 plasma samples and 4 muscle biopsies will be~     collected over a period of 8½ h. Furthermore, muscle skeletal blood flow will be estimated~     using sidestream darkfield imaging (SDF) in sublingual position.~   "
113020|NCT01576835|"~     This study will compare the results of a clinically ordered abdominal CT angiography to a~     research non-contrast MR angiogram (MRA). CTA is a gold-standard for identifying blockages~     in the kidney arteries or other blood vessel problems. CTA requires radiation and contrast~     to obtain useful images. Conversely, the MR abdomen technique being used for the study uses~     no radiation or contrast and is felt to be a safer option for individuals who have kidney~     problems. there is benefit to establishing non-contrast MRA as a clinically accurate test.~   "
113021|NCT01576822|"~     The goal of this study is to assess the feasibility of the approach, conduct a dose-finding~     investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials~     in the assessment of human chemical body burden reduction, for general wellness,~     detoxification, and pain reduction.~      The investigators wish to determine if a hyperthermia-based detoxification protocol is~     feasible to conduct: including assessment of recruitment, enrollment, retention, protocol~     adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).~   "
113022|NCT01576809|"~     This is an open label, in-use study to assess the warming sensation, acceptability and local~     tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as~     a single dose in subjects suffering from symptoms of an upper respiratory tract infection.~     The purpose is to evaluate the acceptability concerning a warming sensation effect and its~     potential benefit in the target population.~      The primary objective is to assess the warming sensation caused by the excipient IFF flavor~     316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg~     per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.~      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and~     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from~     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal~     congestion associated with colds and flu symptoms such as pain, headache and/or fever.~     Subjects must have one or more symptoms per category:~        1. mild to moderate body pain, headache, fever or sore throat~        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing~        3. productive cough Adolescents will be included in the study population~   "
113023|NCT01576796|"~     This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in~     the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III~     NSCLC not amenable to surgery and candidate for chemoradiotherapy.~      Preliminary studies in head and neck cancers have demonstrated the feasibility and support~     the medical benefit of this novel approach.~      The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement~     (boost) in this difficult medical condition for which only limited treatment options are~     available.~   "
113024|NCT01576783|"~     The purpose of this study is to examine whether supplementation with certain polyunsaturated~     fatty acids can help the cognitive development of children born preterm.~   "
113025|NCT01576770|"~     The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch),~     used to numb the skin before IV placement, is effective in reducing pain associated with~     propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl~     Chloride topical anesthetic skin refrigerant.~   "
113026|NCT01576757|"~     The purpose of this study is to determine whether the harvest, isolation and culture of~     cardiac stem cells from endomyocardial biopsies is feasible.~   "
113042|NCT01576549|"~     This study will investigate how LY2127399 works in participants with rheumatoid arthritis~     (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399~     via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study~     procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA~     activity.~   "
113043|NCT01576536|"~     The aim of the study is to test whether genetic variation in the alpha 2A adrenergic~     receptor affects diurnal variation in platelet aggregation.~   "
113027|NCT01576744|"~     Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect~     of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the~     gonadotrophin and steroid status affect the serum levels of this marker. Findings will be~     compared to serum concentrations of CA-125, which is currently the most often used marker~     for ovarian cancer.~      The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in~     20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist~     suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following~     embryo transfer at the time of the hCG-test. The ovarian follicle count and the serum~     estradiol concentrations are recorded throughout the treatment. The serum biomarker HE4 is~     expected to ba a stable marker, which does not respond significantly to hormonal~     stimulation.~   "
113028|NCT01576731|"~     As a measure of secondary prophylaxis, and with the final objective of avoiding the~     infection, it has been suggested to use antiretroviral therapy. This is known as~     post-exposure prophylaxis (PEP).~      Although there are different recommendations, almost every guideline recommend using 3 drugs~     as PEP both in USA and Europe.~      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are~     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.~      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus~     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a~     high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.~   "
113029|NCT01576718|"~     This is a randomized, double-blind, placebo and open-label active controlled,~     parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and~     older with severe persistent asthma who remain symptomatic despite high dose inhaled~     corticosteroid (ICS) therapy. The primary objective of this study is to evaluate the dose~     response, efficacy and safety of 4 different doses of fluticasone propionate (Dose 1, Dose~     2, Dose 3, and Dose 4) delivered as Fluticasone Dry Powder Inhaler (Fp DPI) when~     administered twice daily.~   "
113030|NCT01576705|"~     Evaluation of the following in very young children with Down syndrome:~        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically~          and by ultrasensitive thyreostimulating hormone (TSH) assay),~        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,~        -  any interaction between these two treatments.~   "
113031|NCT01576692|"~     This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2~     antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic~     natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory~     neuroblastoma.~   "
113032|NCT01576679|"~     The objective of this study is to establish the efficacy of tPA when used in pediatric~     intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the~     ultrasound appearance or consistency of the drained fluid.~   "
113033|NCT01576666|"~     The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be~     safely given together to patients and/or the dose that will be used in future studies. This~     study will also learn more about how the combination of these two investigational drugs may~     work for patients with certain cancers (specifically metastatic breast cancer, advanced~     pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma~     multiforme).~   "
113034|NCT01576653|"~     In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early~     initiation of appropriate antifungal therapy and thereby survival. Conventional culture is~     still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however,~     is low (50%) and time to results minimum 24 hours.~      Therefore usage of serological tests detecting fungal antigens has increased dramatically~     over recent years. Main advantages of this new methods are rapid results and higher~     sensitivity when compared to conventional culture. One of the most promising serological~     marker currently used is beta-D-Glucan, which is a component of the fungal cell wall.~     ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The~     Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of~     ß-D-Glucan in peripheral blood.~      Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar~     lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic~     performance of the Fungitell Assay in BAL from patients with solid organ transplant or~     hematologic malignancy.~      In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as~     well as PCR will be determined and used as comparators for BDG performance.~   "
113035|NCT01576640|"~     After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse~     shortly after discontinuation of treatment. The purpose of this study was to assess the~     feasibility and effectiveness of a 12-month relapse prevention intervention in recently~     abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation~     phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and~     cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate~     1 week of abstinence, they continued in the relapse prevention phase of the study, where~     they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and~     cognitive behavioral therapy.~   "
113036|NCT01576627|"~     The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory~     properties and a high zinc content, as an alternative zinc compound to be used for~     supplementation or food fortification. The bioavailability of zinc citrate given as a~     supplement to young Swiss adults will be assessed and compared to the bioavailability of the~     commonly used zinc compounds zinc gluconate and zinc oxide.~   "
113037|NCT01576614|"~     Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the~     surgical intensive care unit has an impact on nurse-physician collaboration.~      Study question: Does the addition of mobile video communication provided by RTP affect~     nurse-physician collaboration during off shift rounding in the surgical intensive care unit~     when compared to the more common clinical practice of off-shift rounding using the~     telephone?~   "
113055|NCT01576380|"~     This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof~     of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate~     efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric~     carcinoma (SGC) that have progressed after one or two prior systemic treatments.~   "
113044|NCT01576523|"~     The aim of the study is to assess what happens to C1-esterase inhibitor that is administered~     under the skin of subjects with hereditary angioedema. Three different dosing regimens of~     C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3~     dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor~     in the blood will be measured during each 4-week period. The study will also examine how~     well C1-esterase inhibitor administered under the skin is tolerated by the subjects.~   "
113045|NCT01576510|"~     To employ a fear learning-extinction paradigm with functional magnetic resonance imaging~     (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic~     stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural~     circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement~     in response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.~   "
113046|NCT01576497|"~     EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the~     operator's preference, EUS-FNA with suction or without suction technique has been used. To~     date, little is known about optimal number of to-and-fro motion during each needle pass. As~     usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically,~     more number of to-and-fro motions may be required in EUS-FNA without suction. In this~     circumstance, the contamination of blood in specimen and possible adverse event may occur.~     To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in~     terms of with suction or without suction, this prospective single-blinded randomized trial~     was conducted.~   "
113047|NCT01576484|"~     This is a phase 2, open-label extension study to assess the long-term safety and efficacy of~     REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously~     participating in the R727-CL-1003 study.~   "
113048|NCT01576471|"~     This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept~     study with a parallel group design to evaluate the safety and efficacy of oral Trichuris~     Suis Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely~     active Crohn's disease. This study will also have an optional open-label extension for~     patients completing the double-blind phase of the study.~   "
113049|NCT01576458|"~     The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid~     (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).~      In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP~     received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the~     third trimester of pregnancy. The severity of pruritus was registered. Itching scores and~     serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone,~     prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin~     time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the~     treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and~     analysed.~   "
113050|NCT01576445|"~     When performing total knee replacement surgery, the surgeon has a choice as to which type of~     surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the~     so-called 'medial parapatellar' exposure. And alternative and more recently introduced~     technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the~     muscle at the front of the leg. In this study we compare the two surgical techniques in a~     so-called randomized trial. This means that we put people randomly into two groups, one~     group will receive surgery with the 'Mid-vastus approach' and the other group the surgery~     with the 'Medial parapatellar approach'. It is hypothesized that people who receive the~     Mid-vastus approach recover quicker and have a better short-term functional outcome than~     people who receive the 'Medial parapatellar approach'.~   "
113051|NCT01576432|"~     Objective~      To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to~     skin-to-skin contact versus other methods of non-pharmacological analgesia during blood~     sampling through heel lance in healthy term neonates. The influences of non-pharmacological~     methods on crying time, percentage of crying while sampling, heart rate, number of attempts~     and duration of sampling were studied.~      Methods~      Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of~     a tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed~     and absence of feeding during the previous 60 minutes. Neonates were randomly assigned to~     four groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with~     skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose~     Data for the primary objective was analysed per intention to treat. This study was approved~     by local ethical committee.~   "
113052|NCT01576419|"~     The objective of this study was to to evaluate the efficacy and safety of PG201 in~     osteoarthritis patients.~      This clinical study was designated to be non-inferiority test with level of significance:~     95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%.~     Assuming 20% drop-out rate, the number of subjects required for each treatment group was~     estimated to be 154, while the total number of subjects required for the study 308.~      non-inferiority margin: 8mm~   "
113053|NCT01576406|"~     This study is designed to evaluate the potential effect of hepatic impairment on the~     pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer~     patients with mild, moderate or severe liver dysfunction as well as patients with normal~     liver function will be enrolled in this study.~   "
113054|NCT01576393|"~     Given the reciprocal nature of parent-child interaction, involvement of the adolescent in~     their mother's substance abuse treatment plan might be associated with reductions in adult~     relapse and improvements in child functioning. These findings would support the assertion~     that focus on family dynamics in substance abuse treatment programs is an effective use of~     resources and an important target of intervention efforts. One hundred eighty-three~     substance abusing mothers and their child (n=61 assigned to each condition) will receive~     treatment as usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy~     (EBFT) conducted in the home or 2) Ecologically-based family therapy conducted at the~     treatment center, or 3) an attention control, Women's Health Education (WHE). In order to~     examine the endurance of treatment effects, this project will assess the parent and child at~     3, 6, 12, and 18 months post-baseline.~      Hypotheses~        1. It is expected that 1) mothers and children assigned to home and office based family~          therapy will show greater reductions in substance use and improvement in individual and~          family functioning at post-treatment compared to those in the attention control, and 2)~          those assigned to home-based family therapy will show greater reductions in substance~          use and improved individual and family functioning at post-treatment compared to those~          assigned to office-based family therapy.~        2. It is expected that 1) those assigned to home or office based family therapy will~          continue to maintain improvements in substance use, individual and family domains over~          time (time by treatment interaction) compared to those assigned to the attention~          control and 2) those assigned to home-based family therapy will continue to maintain~          improvements in substance use, individual and family domains over time (time by~          treatment interaction) compared to those assigned to office-based family therapy.~        3. It is hypothesized that improved family interaction skills will mediate substance use,~          individual and family outcomes.~        4. It is expected that EBFT in the home and EBFT in the office will be more cost effective~          than TAU, and that EBFT in the home will be more cost effective than EBFT in the office~   "
113057|NCT01576354|"~     The objective of the present investigator-initiated mono-center trial to be performed at the~     Department of Neurology of the University Hospital Zurich is a detailed characterization of~     the effects of prolonged-release fampridine on walking function of 50-70 patients with MS.~     In a randomized, double-blind, placebo-controlled study with cross-over design, changes of~     essential gait elements such as stability, coordination, correct loading, posture or~     endurance in addition to walking speed after treatment with prolonged-release fampridine~     will be investigated using a comprehensive kinematic gait analysis protocol. This protocol~     comprises outcome parameters ranging from very specific and sensitive biomechanical measures~     to clinically meaningful indicators of improved ambulatory function. Kinematic, kinetic and~     electromyographic gait parameters will be assessed during treadmill walking (primary outcome~     parameters). Changes in overground walking capacity will be investigated by means of~     different functional walking tests (e.g. six minute walk test). Furthermore, the patient's~     perception of the effects of the treatment on walking function will be evaluated by a~     standardized questionnaire. Changes of global ambulatory activity will be assessed~     (Actimeter) indicating a successful translation of improved gait (sub-)functions due to~     prolonged-release fampridine treatment into everyday life. The study will last for a period~     of 18 weeks, excluding the screening period. Based on the mechanism of action, the~     investigators hypothesize that treatment with prolonged-release fampridine will not only~     improve walking speed, but also clinically more meaningful features of walking function in~     patients with MS.~        -  Trial with medicinal product~   "
113058|NCT01576341|"~     The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa~     administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney~     disease (CKD)~   "
113059|NCT01576328|"~     This study is being conducted to assess the overall safety and tolerability of a single~     intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in~     subjects with Type 2 Diabetes inadequately controlled on Metformin.~   "
113060|NCT01576315|"~     Aspergillus infection is an infectious complication which frequently occurs in cystic~     fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent~     positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole~     and voriconazole in this indication has never been evaluated in a large prospective~     controlled clinical trial, even though many teams already use it. The ATCF study aims to~     assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the~     efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for~     Aspergillus.~   "
113061|NCT01576302|"~     Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent~     regurgitation of recently ingested food. Very little is understood about the nature and~     treatment of this disorder. The act of regurgitation in rumination involves the opening of~     the upper esophageal sphincter and the muscular contraction of the abdomins rectus.~     Behavioral treatment of these symptoms is the clinical intervention of choice; however, only~     uncontrolled case documentation exists to support its effectiveness. However, an effective~     behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint,~     muscular relaxation is incompatible with the necessary muscular contraction for rumination.~      To date, single case documentation and few designed single case studies have examined the~     clinical effectiveness of behavioral interventions for GI rumination. In the current study,~     the investigators seek to examine the effectiveness of two behavioral relaxation~     interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our~     primary goals are to examine the clinical effectiveness of these interventions in symptom~     reduction at 1- and 3-month follow-up.~   "
113062|NCT01576289|"~     Multicenter study to correlate histological findings in the upper gastrointestinal tract~     with endoscopic and clinical data.~   "
113063|NCT01576276|"~     Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of~     morphine and ketorolac on brain activity in response to pain stimuli as measured by~     functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study~     will be conducted on six separate days not requiring an overnight stay in the hospital.~   "
113064|NCT01576263|"~     Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications~     even in elderly patients with previous or current medical conditions. Especially comorbidity~     like cardiovascular diseases and conditions with increased risk of bleeding or previous~     thrombo-embolic events are major challenges.~      To facilitate safe use of ropivacaine as an analgesic, information on the concentrations~     levels after autologous blood transfusion following local infiltration analgesia is very~     crucial. However, very limited data are available. To verify the safety of autologous blood~     transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total~     knee arthroplasty or total hip arthroplasty.~   "
113065|NCT01576250|"~     The purpose of this study is to investigate the effects of lowered physical activity~     (resulting in decreased muscle mitochondrial oxidative capacity) alone and together with~     increased plasma free fatty acid availability (by infusion of a clinically widely used lipid~     emulsion (Intralipid)) on insulin sensitivity and glucose and lipid metabolism. To this end,~     we will compare skeletal muscle insulin sensitivity and glucose and lipid metabolism (within~     one subject) after 9 days of immobilization of one leg (unilateral lower limb~     suspension(ULLS))(decreased muscle mitochondrial oxidative capacity) versus an active~     control leg (unchanged muscle mitochondrial oxidative capacity). Further, changes in IMCL~     and fatty acid intermediates will be investigated in the immobilized vs the control leg, and~     this will be related to insulin sensitivity. The effectiveness of the ULLS intervention will~     be tested by measuring muscle mitochondrial oxidative capacity in both the immobilized and~     the control leg. All measurements will be performed both in the immobilized and control leg~     after 9 days of ULLS.~   "
113066|NCT01576237|"~     During a five years period the participating transfusion medicine establishments will report~     all their non-trivial adverse events (AE) occurring during preparative hemaphereses.~     Complications may be related to the blood donors, the blood products, the disposables or the~     apheresis devices. The study hypothesis regarding each participating center is that their~     procedure-related AE rate is not higher than the respective rate of all other centers in~     total.~   "
114218|NCT01561157|"~     The objective of this protocol is to conduct a longitudinal multidisciplinary investigation~     of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and~     mortality in people with these disorders.~   "
113067|NCT01576224|"~     The aim of this study is to investigate the post operational mobilization after volar~     locking plate osteosynthesis of distal radius fractures. One group is admitted training~     exercises just after the fracture treatment, one group after 14 days immobilization in a~     cast.~      The primary hypothesis is, that immediate training leads to earlier and faster recovery.~      Our second hypothesis is, that immediate training does not lead to increased risk of~     fracture displacement.~   "
113068|NCT01576211|"~     RATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor~     tissue samples from patients with Wilms tumor.~   "
113069|NCT01576198|"~     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in~     the laboratory may help doctors to learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms~     tumor.~   "
113070|NCT01576185|"~     These laboratory trial studies the development and treatment of a mouse model for acute~     myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples~     from patients with cancer in the laboratory may help doctors learn more about cancer and how~     well patients will respond to treatment.~   "
113071|NCT01576172|"~     This randomized phase II trial studies abiraterone acetate and prednisone together with~     veliparib to see how well it works compared to abiraterone acetate and prednisone alone in~     treating patients with hormone-resistant prostate cancer that has spread from the primary~     site to other places in the body. Androgens can cause the growth of prostate cancer cells.~     Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by~     the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving abiraterone acetate together with prednisone and veliparib~     may work better than abiraterone acetate and prednisone alone in treating patients with~     hormone-resistant prostate cancer.~   "
113072|NCT01576159|"~     Acute effects of physical exercise on the deformational behavior of articular cartilage and~     changes in cartilage oligomeric matrix protein (COMP) are definite. However, conclusive~     positive effects of fitness exercise on functional adaptation of articular cartilage have~     not been proved.Therefore, in this parallel-group randomized control trial, the~     investigators tested the hypothesis that adequate amount of physical exercise with enough~     impact would be able to stimulate the functional behavior of articular cartilage.~      The investigators evaluated 44 healthy males for their physical fitness levels and their~     blood samples were obtained before, immediately after and 0.5 h after a 30-min walking~     exercise. Thereafter, participants were assigned to the running, the cycling, the swimming~     and the control groups. At the end of 12-weeks of intervention, same measurement procedures~     were applied. Mixed repeated-measures ANOVA design was used for statistics. (Level of~     evidence: 2)~   "
113073|NCT01576146|"~     The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly~     intravenous (IV) administration of KAI-4169 in the treatment of secondary~     hyperparathyroidism (SHPT) in hemodialysis subjects.~   "
113074|NCT01576133|"~     The purpose of the study is to determine whether a combination of occupational therapy~     visits, nursing visits, and handyman repair are effective in helping low income older adults~     avoid costly health care services~   "
113075|NCT01576120|"~     The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients,~     using the PillCam Colon system.~   "
113076|NCT01576107|"~     Impact of a 4-week exercise intervention vs. a stress-management-training on physical~     activity (measured objectively and by questionnaire) of cancer patients of different~     entities and out-patient regimes.~   "
113077|NCT01576094|"~     Congenital heart defects are the most prevalent group of congenital malformations in~     newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for~     the unfavourable outcome of this population. The early use of inodilators (INDs),~     specifically milrinone (MR), is proposed to reduce afterload and increase inotropism.~     Studies in the paediatric population appear to support a clinical usefulness of MR similar~     to that observed in adults. Levosimendan (LEVO) is a novel class IND developed for the~     treatment of heart failure. Experience with LEVO in paediatric patients is scarce. The~     purpose of this study was to systematically test the efficacy and safety of milrinone (MR)~     and levosimendan (LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary~     bypass (CPB). Given the uncertainty about LEVO pharmacokinetics in neonates, the study was~     designed as a pilot, phase I feasibility study.~   "
113078|NCT01576081|"~     The present study aimed to investigate the importance of gravitational induced forces that~     appear during normal ambulation for the health of muscles, bones and blood vessels. The main~     hypothesis of the present study is that gravitational loading alone, without muscle~     contractions, is insufficient to maintain bone strength.~   "
113079|NCT01576068|"~     Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators~     country, underdiagnosis has been estimated in around 80% of subjects. Early detection is~     done mainly in primary care but due to actual situation new alternatives have been proposed~     to decrease underdiagnosis.~      This present study promote by a multidisciplinary research team (respiratory medicine,~     primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD~     case finding program guide by spirometry in community-pharmacies.~      From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in~     which the investigators showed the feasibility of spirometry in community-pharmacies for the~     early detection of COPD, the investigators have design a second phase to evaluate the effect~     of this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk~     customers and will conduct a spirometry in agreement with the design protocol. 3600~     spirometries is the establish objective. Participants hospitals will train pharmacist in~     spirometry and also control spirometry quality daily by a telematic pathway. Spirometry~     results will be evaluate in terms of effect and costs. The investigators will also evaluate~     the impact of this program in the health system by numbers of subjects diagnosed and follow~     up in primary care.~   "
113202|NCT01574534|"~     The investigators hypothesize that in a real-world population undergoing percutaneous~     coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3~     mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents~     (DES).~   "
113080|NCT01576055|"~     The primary objective of the randomized study is to evaluate the safety and effectiveness of~     the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic~     lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries~     (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).~   "
113081|NCT01576042|"~     The purpose of this pilot trial is to determine the feasibility of a large, multi-center~     randomized clinical trial aimed to test whether a treatment strategy of percutaneous~     catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art~     pharmacologic therapy at reducing all-cause mortality in patients with an implantable~     cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible~     cause.~   "
113082|NCT01576029|"~     Primary Objective:~        -  To compare the continuation of treatment with docetaxel versus switching to cabazitaxel~          regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in~          patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of~          docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or~          increase of up to 24% in PSA levels.~      Secondary Objectives:~        -  PSA response rate~        -  Overall survival (OS)~        -  Incidence of Adverse Events~   "
113083|NCT01576016|"~     The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety~     and efficacy of the Accent MRI™ System in a patient population indicated for implant of a~     pacemaker within and outside of the MRI environment.~   "
113084|NCT01576003|"~     The purpose of this research study is to evaluate the effects (good and bad) of~     supplementation with Glutamine to that of a placebo (L-alanine), on your child and their~     Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine~     to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream~     infections, improving growth, and/or changing the make-up of bacteria in your child's~     intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In~     this study, the investigators will be assessing how well Glutamine affects Short Bowel~     Syndrome in children.~   "
113085|NCT01575990|"~     The purpose of this research study is to explore ways to improve appropriate colorectal~     cancer (CRC) screening in the elderly by attempting to target screening in those most likely~     to benefit and avoiding screening in those least likely to benefit.~   "
113086|NCT01575977|"~     The main objective of this study is to predict cartilage contact pressures in the hip after~     periacetabular osteotomy (PAO).~   "
113087|NCT01575964|"~     The purpose of this study is to determine the influence of FAI abnormalities on hip joint~     biomechanics.~   "
113088|NCT01575951|"~     This is a pilot study to determine the diagnostic value of dynamic contrast enhancing MRI~     (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular~     permeability and microvessel density before and after preoperative radiotherapy.~   "
113089|NCT01575938|"~     The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction~     intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition~     or transmission.~   "
113090|NCT01575925|"~     The purpose of this study is to determine the pharmacokinetics (PK) and safety for the~     combination of pomalidomide (POM) + low-dose dexamethasone (LD-DEX) in subjects with~     relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.~   "
113091|NCT01575912|"~     Differences in pain perception between subjects with and without psychiatric illness may be~     influenced by the individual experience, and not primarily by the pathology, although the~     pathological frame may amplify it.The aim of this study is to establish if the~     characteristics of experimental pain feeling are influenced by the past pain experience,~     anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated~     by an inventory of the potentially painful situations that one can come across through the~     life, to determine the following points : Number of painful events in the past, number of~     painful points during the last 6 months, number of painful events lasting more than 6~     months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum~     of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly~     affective, mostly sensorial, or both).~      Schizophrenic, depressed and control participants will be recruited, and their pain~     experience throughout life will be put it in relation to experimental pain tests results~     (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and~     Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR)~     variation, Blood Pressure (BP) variation.~   "
113092|NCT01575899|"~     This prospective controlled randomized open-label clinical trial is designed to determine~     the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen~     compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in~     Eastern Taiwan.~   "
113093|NCT01575886|"~     The goal of this study is to test an intervention that teaches clinicians to integrate the~     use of 'teachable moments' with the key skills of motivational interviewing tailored to~     address smoking and weight management in the primary care outpatient visit setting.~   "
113094|NCT01575873|"~     This study is being conducted in patients taking glucocorticoids for treatment of various~     diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.~   "
113095|NCT01575860|"~     This study is being conducted to evaluate the overall safety of lenalidomide (also known as~     Revlimid) in patients with lymphoma, and to determine whether it is effective in preventing~     this disease from returning after stem cell transplant. This study will also determine the~     dose of lenalidomide that can be given without causing severe side effects. Lenalidomide has~     not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of~     lymphoma. At least 28 people will be enrolled on this study at the University of~     Pennsylvania.~   "
113108|NCT01575691|"~     5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS).~     Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase~     the effects of 5-aza. The goal of this clinical research study is to find the highest safe~     dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and~     all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness~     of this combination therapy will also be studied.~   "
113109|NCT01575678|"~     Aim: To investigate the effect of melatonin in bedwetting.~   "
113096|NCT01575847|"~     This study is a non-intervention, clinical study to test research use only APAP protein~     adducts dipsticks in human blood samples. The study will be conducted in two phases. In~     phase 1, the research use only dipsticks and dipstick testing components will be tested for~     feasibility in the emergency department at UAMS. Patients will be enrolled that are having~     an acetaminophen level obtained as part of their medical evaluation. In phase 2, the~     research use only dipsticks will be tested in centers that participate in the Acute Liver~     Failure Study Group (ALFSG), a clinical research network funded by the National Institutes~     of Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical~     registry of the ALFSG will be approached for enrollment. These patients all have the~     diagnosis of acute liver failure or acute liver injury from a variety of etiologies,~     including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing~     by the dipstick and 2) testing by high performance liquid chromatography with~     electrochemical detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also~     be determined from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks~     will be read manually and by dipstick readers by independent testers that are not directly~     involved in the clinical care of the patients. The results of the two dipstick readings will~     be recorded, will remain confidential and will not be used in the diagnosis or management of~     the patient. The results of the dipsticks and HPLC-EC assays will be compared to the final~     patient diagnoses.~   "
113097|NCT01575834|"~     The purpose of this study is to determine if treatment is effective in preventing fractures~     in women with postmenopausal osteoporosis~   "
113098|NCT01575821|"~     Cough is a common symptom in pediatric practice. It can be particularly troubling to~     children and their parents.It often results in discomfort to the child and loss of sleep to~     both the child and the parent. The objective of this trial was to compare the effects on~     nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of~     three different honey products compared to placebo~   "
113099|NCT01575808|"~     The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment~     of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be~     measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured~     by comparison to Surgical Bypass data derived from a retrospective study.~   "
113100|NCT01575795|"~     This is a multi-center, prospective, randomized, single-blind, investigator initiated,~     pharmacodynamic study of parallel design, performed at 3 institutions (Patras University~     Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).~      Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing~     primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present~     high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary~     intervention, will be randomized after informed consent, in a 1:1 ratio to either:~      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting~     12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance~     dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at~     randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow~     assay, in platelet reactivity units (PRU).~      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent~     revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic~     Research Consortium criteria) will be performed until patient's discharge.~   "
113101|NCT01575782|"~     Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial~     chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3~     patients.~   "
113102|NCT01575769|"~     This long-term, interventional, open-label extension study will evaluate the safety and~     efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with~     polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients~     will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study~     treatment is 104 weeks.~   "
113103|NCT01575756|"~     The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy~     and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with~     congenital fibrinogen deficiency~   "
113104|NCT01575743|"~     The aim of the present study is to investigate the impact of regular aerobic exercise on~     psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological~     functioning in people suffering from professional burnout. Pre- and postassessments after 12~     weeks of training will be performed.~   "
113105|NCT01575730|"~     Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable~     patients with surgery followed by instillation of heated chemotherapy inside the abdominal~     cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or~     HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug~     active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this~     study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90~     minutes) may be safer and at least as efficient. Patients will be treated with one of three~     possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min,~     37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and~     pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer~     cell kill effects will be compared in order to establish the safest and most active HIPEC~     regimen.~   "
113106|NCT01575717|"~     The purpose of this study is to investigate the effect of two different doses of vitamin D3~     (2000 IU vs. 4000 IU) on serum 25-hydroxyvitamin D (25OHD) levels in patients with~     hepatocellular carcinoma on the liver transplant list. The study will help determine the~     dose of vitamin D3 that is required for patients with liver cancer to reach a normal level~     of 25OHD in the blood.~   "
113107|NCT01575704|"~     The purpose of this randomized controlled two-part study examines the effects of a~     structured sports intervention before, during and after hematopoetic stem cell~     transplantation (hsct) in children and adolescents.~      The main aspects in the sports groups are resistance, endurance and flexibility training.~     The control group performs a mental training as well as relaxation exercises.~   "
113124|NCT01575483|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Onglyza® so that the regulatory authority can manage the marketing approval~     properly.~   "
113110|NCT01575665|"~     Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing~     which has proven hard to treat effectively. The investigators hypothesised that by~     periodically inducing normocapnia over several weeks, it would be possible to raise the~     normal resting level/set point of CO2 and achieve a reduction of symptoms.~      Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing~     mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.~      Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline~     and once each week at least three hours after mask use, as well as spirometric values,~     breath holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire~     (NQ),.~   "
113111|NCT01575652|"~     The objective of this study was to examine the effects of angiotensin converting enzyme~     inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in~     peritoneal dialysis patients.~   "
113112|NCT01575639|"~     Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal~     treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no~     consensus on the dosage of Prednisolone required for the treatment of infantile spasms.~     Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual~     dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these~     doses. A higher steroid dose may also be associated with more side effects. Therefore, this~     study was planned to compare the efficacy and tolerability of the high dose versus the usual~     dose in children with infantile spasms, in a randomized open-label trial design~   "
113113|NCT01575626|"~     One important goal in anesthetic management during ocular surgery is to provide adequate~     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients~     with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect~     of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist~     of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with~     short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to~     reduce the IOP. To this end there is no data in the literature to support or disprove this~     finding.~      Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant~     effect on the IOP.~   "
113114|NCT01575613|"~     In this study, the investigators propose to determine the value of rolling out four targeted~     malaria control efforts in reducing overall malaria transmission. These targeted control~     efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In~     addition, larviciding will be employed to target malaria vectors, also those that are less~     susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the~     human infectious reservoir will be reduced in hotspots of malaria transmission by treating~     parasite carriers and their household members with the current first-line antimalarial drug.~     The impact of these targeted interventions on overall transmission intensity will be~     assessed in the context of currently ongoing malaria control activities in a plausibility~     study. Hotspots of malaria transmission are defined in an area of 100km2 and randomized to~     receive hotspot targeted interventions and compared with their baseline and with control~     clusters where the routine (untargeted) malaria control activities continue. The~     interventions will be evaluated based on changes in parasite prevalence measured in~     community surveys inside and outside hotspots of malaria transmission. Parasite prevalence~     will be compared before and after the intervention in intervention clusters and between~     intervention and control clusters.~      In addition to malaria surveys in the human population, an entomological evaluation will~     take place where the densities of mosquito larvae and adult mosquitoes are monitored~     longitudinally.~   "
113115|NCT01575600|"~     The purpose of this randomized clinical trial is to evaluate the interaction of intravenous~     fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The~     hypothesis is that perioperative supplemental intravenous fluid administration reduces the~     incidence of postoperative vomiting.~   "
113116|NCT01575587|"~     The purpose of this study is to evaluate the effect of timing of food intake on systemic~     abiraterone exposure observed in healthy adult Japanese and Caucasian men.~   "
113117|NCT01575574|"~     This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of~     hepatocellular carcinoma~   "
113118|NCT01575561|"~     This is an open-label, multi-center,12 week extension study designed to evaluate the longer~     term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to~     lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either~     completed the core study D1050296 or experienced a protocol defined recurrence of a mood~     event in the double-blind phase of the core study D1050296~   "
113119|NCT01575548|"~     This randomized phase III trial studies how well pazopanib hydrochloride works compared to~     placebo in treating patients with kidney cancer that has spread to other parts of the body~     who have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood~     flow to the tumor.~   "
113120|NCT01575535|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies bone marrow samples from women with acute myeloid~     leukemia.~   "
113121|NCT01575522|"~     This phase II trial studies how well tivantinib works in treating patients with recurrent or~     metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
113122|NCT01575509|"~     This study aims to determine the 2 hour glycemic responses of two bread products and one~     dried lingonberry product. The average postprandial response of each product is compared~     with glycemic response after ingestion of control solution with a similar carbohydrate~     content (glucose, glucose-fructose) as the provided by the respective test product.~   "
113123|NCT01575496|"~     The purpose of this study is to determine if repeated sessions of transcranial direct~     current stimulation (tDCS) are effective for treating chronic subjective tinnitus. Previous~     studies have reported brief improvements in tinnitus after safe and noninvasive stimulation~     of the auditory cortex or limbic system. The investigators hypothesize that a greater~     improvement in tinnitus will be achieved following repeated sessions of tDCS that target~     both auditory and limbic systems.~   "
113126|NCT01575457|"~     The purpose of the Harriet Lane Clinic Healthy Futures Program is to increase academic or~     workforce development success among adolescents and young adults. To this end, the Healthy~     Futures educational intervention includes motivational interviewing and knowledge and skill~     building activities that will focus on improving educational, vocational, health, and self~     sufficiency outcomes for youth who attend the Harriet Lane Clinic. Goals of this youth~     development project include determining what factors are associated with school engagement,~     parental academic involvement, and future planning.~   "
113127|NCT01575444|"~     This proposal has been developed through collaboration between the University of Minnesota~     and New American Community Services (NACS), and the research design is based on a needs~     assessment conducted by the community partner. The investigators will test the hypotheses~     that women who are offered home vaginal bio-specimen collection will have higher rate of~     cervical cancer screening completion than that of women referred for clinic-based Pap test.~     All participants will be given identical education materials on cervical cancer screening~     and HPV, currently in use by the Minnesota Sage Program.~   "
113128|NCT01575431|"~     The aim of this study is to prospectively investigate the relationship of circulating~     endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent~     development of in-stent restenosis or progression of coronary atherosclerosis.~   "
113129|NCT01575418|"~     This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied~     tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal~     formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be~     enrolled.~      Each participant will receive two inpatient doses of each radiolabeled study product. The~     first inpatient dose of each product will be administered without coital dynamics simulation~     (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post~     dose with instillation of radiolabeled autologous semen. There will be a washout period of~     at least 11 days between each dose.~   "
113130|NCT01575405|"~     This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo~     efficacy study of three rectally-applied tenofovir-based microbicide formulations.~     Approximately 18 total evaluable HIV-negative men and women (~9 per site) will be enrolled~     across two study sites: University of California at Los Angeles (UCLA) and Magee-Womens~     Research Institute (MWRI) at University of Pittsburgh.~      Each participant will experience seven rectal exposures to the rectal-specific formulation~     (RF) and seven rectal exposures to the reduced glycerin vaginal formulation (RGVF) of~     tenofovir 1% gel, but only one exposure to the vaginal formulation (VF), which will be~     coupled with six preceding exposures to the Universal HEC Placebo Gel to balance out the VF~     study stage. Participant accrual will take approximately 6 months and each participant will~     be on study for approximately 3 months. The total duration of the study will be~     approximately 1 year.~      The primary objectives of the study are safety, acceptability, and pharmacokinetics,~     specifically:~        -  To evaluate the safety of each tenofovir-based microbicide gel formulation when applied~          rectally~        -  To evaluate the acceptability of each tenofovir-based microbicide gel formulation when~          applied rectally~        -  To compare systemic and compartment pharmacokinetics among the three tenofovir-based~          microbicide gel formulations when applied rectally~      Secondary objective of the study is to evaluate the mucosal immunotoxicity of each~     tenofovir-based microbicide gel formulation when applied rectally.~      And the exploratory objective of the study is to assess the preliminary (ex vivo) efficacy~     of each tenofovir-based microbicide gel formulation using biopsy explants after each product~     is applied rectally.~   "
113131|NCT01575392|"~     In clinical practice the 24-hour creatinine clearance is often used to obtain an impression~     of renal function. However, the glomerular filtration rate is considered to be the best~     indicator of renal function. For practical and financial purposes, GFR is often estimated by~     means of serum creatinine based equations. These equations are also used in internation~     guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine~     measurements are important to make reliable estimates of renal function. However, previous~     research has revealed a large variability in creatinine measurements using different~     measuring methods. In this study the investigators aim to establish the degree of~     variability in different methods to measure creatinine in a heterogenous group of Caucasian~     people with and without renal function loss and the influence of this variability on renal~     function estimating equations and the 24-hour creatinine clearance.~   "
113132|NCT01575379|"~     Recent evidence from epidemiological studies suggests that serum uric acid levels higher~     than average predispose diabetic patients to kidney damage. The purpose of this study is to~     gather preliminary information on whether lowering serum uric acid by means of oral~     allopurinol (a drug commonly used for the treatment of gout) can be used to prevent or delay~     the loss of kidney function that may accompany diabetes. The results of this study will help~     us design a larger study to find out whether this medication can prevent kidney problems, in~     particular the loss of kidney function, in people with type 1 diabetes.~   "
113133|NCT01575366|"~     Aim 1. Determine whether higher-velocity finger tracking training improves hand function~     more than slower velocity training. Working hypotheses: The higher-velocity training will~     have significantly greater functional improvement compared to the lower-velocity training,~     as measured by standardized upper extremity functional tests (Jebsen Taylor test, Box &~     Block Test, and Finger extension force test)~      Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces~     cortical reorganization as compared to lower-velocity finger tracking training.~      Working hypotheses: The higher-velocity training will have significantly greater cortical~     reorganization compared to the lower-velocity training, as measured by:~        1. TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor~          digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area~          (M1).~        2. fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional~          M1.~      Aim 3. Explore whether the functional improvements correlate with the cortical~     reorganization. Working hypotheses: The functional improvements will correlate with the~     cortical reorganization.~   "
113134|NCT01575353|"~     The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and~     Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is~     that nasal high-flow may be superior to the Venturi mask in terms of oxygenation~   "
113136|NCT01575327|"~     The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen~     Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test~     in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and~     hypercapnia.~      The study was designed to test the following hypotheses:~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher~     exercise tolerance (distance during ESWT) and lower desaturation events without increase in~     hypercapnia in patients with COPD, oxygen therapy and hypercapnia.~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea~     and leg fatigue scores at a given endurance time during the shuttle walking test in patients~     with COPD, oxygen therapy and hypercapnia.~      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac~     and respiratory frequencies at a given endurance time during the shuttle walking test in~     patients with COPD, oxygen therapy and hypercapnia.~   "
113137|NCT01575314|"~     The purpose of this study is to compare the efficacy and cost difference of using a~     parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with~     lung disease (mass or others).~   "
113138|NCT01575301|"~     The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists~     and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these~     agents.~   "
113139|NCT01575288|"~     The proposed study will assess the ability of a naturally occurring sugar to improve the~     function of arteries with age. Overall, the proposed research project has the long-term~     potential to influence clinical practice guidelines by establishing a novel, easy to~     deliver, cost-effective therapy for treating age-associated arterial dysfunction and~     reducing the risk of cardiovascular disease with age.~   "
113140|NCT01575275|"~     The purpose of this study is to investigate the safety and performance of an investigational~     agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for~     visualizing a tumor during surgery. It is also being studied to determine if there are~     differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance~     imaging (MRI)~   "
113141|NCT01575262|"~     The purpose of this study is to investigate the effectiveness of using incentives to~     encourage adults to be physically active.~   "
113142|NCT01575249|"~     The investigators aim to identify all clinical, biological, echo and imagistic parameters~     that predispose to increased progression rates in a prospective observational trial which~     will include ONLY patients with moderate AS, with the complete cardiological investigational~     tools provided in 2012. Once those parameters are found, medical and interventional~     treatment could be implemented to decrease the mortality rates.~   "
113143|NCT01575236|"~     The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,~     fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the~     LMA SupremeTM in paralyzed, anesthetized patients.~   "
113144|NCT01575223|"~     Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™)~     offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early~     post-operative management in patients with chronic rhino sinusitis.~   "
113145|NCT01575197|"~     The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on~     alternate dosing schedules will enhance the immune response to the vaccine in a~     low-resource, high-burden country in Africa. Alternate dosing schedules studied include~     giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of~     the vaccine.~   "
113146|NCT01575184|"~     Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing~     major surgery. Although it has been suggested that head rotation increases the degree of~     overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation~     is extremely difficult in infants. The aim of the present study is to evaluate whether the~     caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between~     IJV and CA in infants during head rotation.~   "
113147|NCT01575171|"~     Behavioral economics represents a powerful, albeit underutilized tool to influence provider~     and systems behavior in a large-scale, meaningful, and sustainable way. The investigators~     propose to use a sophisticated electronic health record (EHR) system to change the default~     choice for physicians to the choice most supported by clinical practice guidelines (CPG).~      Multiple guidelines exist describing best practices for effective interventions, yet a large~     gap persists between actual and optimal guideline compliance. The proposed study will~     examine the comparative effectiveness of an opt-out medication management protocol relative~     to usual care for patients not at goal, using national guidelines for cholesterol management~     implemented in large multispecialty private practices that use an Electronic Health Record~     system.~      Specific Aim: To determine the effectiveness of altering the default option in an EHR in~     prescribing statins to selected patients using clinical decision support.~      Hypotheses: Compared to usual care, a CPG-concordant intervention designed using behavioral~     economics principles will significantly improve the proportion of patients who are~     prescribed statins.~   "
113148|NCT01575158|"~     citalopram and clomipramine are better than placebo in preventing new episodes of depression~     in patients with recurrent depression~   "
113149|NCT01575145|"~     The study is being done to determine whether an in-hospital intervention using a brief~     intervention to facilitate quitline utilization will increase quitline utilization by~     hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.~      Study participants will be randomized to receive either a brief quitline facilitation~     intervention , or a control intervention of a brief stop-smoking message.~      The study will also compare healthcare costs and utilization in the first six months~     following hospitalization between the two groups.~   "
113150|NCT01575132|"~     The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS)~     for patients with Parkinson's Disease. We have data for patients operated with DBS since~     1998. We wish to examine the effect of stimulation on motor symptoms as well as make a~     follow-up on complications and side-effects related to treatment. We also wish to follow-up~     on the quality of life-studies made in the years 2003-2008.~   "
113390|NCT01571999|"~     This study will assess the safety and pharmacokinetics of inhaled GSK573719 and~     GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal~     impairment. The results of the study will provide guidance on the use of this product in~     subjects with severe renal impairment.~   "
113151|NCT01575119|"~     Smokers have three choices when faced with surgery: keep smoking, quit for a short time~     around surgery or quit for good. In the first specific aim, a decision aid was designed to~     help facilitate the discussion of these choices between smokers and healthcare providers.~     This second aim will test whether this decision aid improves the decisional quality compared~     with standard methods used to discuss perioperative smoking.~   "
113152|NCT01575106|"~     This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how~     contextual learning/expectation relieves or aggravates pain experience in the same cohort of~     subjects and the same study session.~   "
113153|NCT01575093|"~     This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2~     Capsule Endoscopy.~   "
113154|NCT01575080|"~     The purpose of this study is to determine if untrained subjects who have diabetes can~     operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.~   "
113155|NCT01574040|"~     Rationale: Lifestyle modifications, such as increasing physical exercise and reducing~     dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity~     and mortality. Relevant improvements can already be achieved by small adaptations in~     everyday life. It is unclear whether simple low-cost interventions in the working~     environment can promote such healthy lifestyle adaptations.~      Objective: To study the effect of low-cost interventions for promoting healthy lifestyle~     modifications.~      Study design: Before-and-after intervention study. The study period will be subdivided in~     four parts of 2 weeks each: a run-in period, a before-measurement period, an~     intervention-period, and an after measurement period.~      Study population: Staff and visitors of the University Medical Center Utrecht.~      Study interventions:~        -  Promotion of stair climbing.~        -  Promotion of a low-salt soup alternative for the 'soup of the day'.~        -  Promotion of a low-fat alternative for the butter croissants.~        -  Exchange of the basket positions of butter and margarine between convenient and harder~          to reach locations.~      Outcome measures:~        -  Number of passages through each part of the stair cases.~        -  Number of low-salt cream soup and normal clear soup cups sold in the hospital~          restaurant and ratio between them.~        -  Number of low-fat and normal croissants sold in the hospital restaurant and the ratio~          between them.~        -  Number of low-fat margarine servings and butter servings sold in the hospital~          restaurant and the ratio between them.~   "
113156|NCT01574027|"~     Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30~     years, but has never been directly studied in humans. The biologically active version of~     vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause~     serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side~     effect. The investigators previous research suggests that the enzyme necessary to convert~     25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine~     (colon).~      Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped~     cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely~     uses methods that allow ACF counting to be done as a part of standard practice. ACF's are~     not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC~     decreases.~      The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or~     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary~     objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to~     placebo, causes significant reduction of ACF number from baseline levels. The primary~     endpoint will be change in ACF number.~   "
113157|NCT01574014|"~     Social phobia is the third most common psychiatric disorder besides depression and~     alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy~     in the treatment of social phobia. Nevertheless, there is no effect in a third of the people~     at the existing treatment methods. Pharmacological therapies have similar effects, but there~     is a high rate of relapse after discontinuation of medication.~      Social phobia is characterized by fear of performance or interaction situations. The strong~     fear of negative evaluation by others is usually accompanied by a marked avoidance behavior~     and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The~     confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive~     memories, resulting in an immediate anxiety response. Several studies had already shown that~     elevated glucocorticoids impair retrieval of declarative memory contents in healthy~     subjects. The investigators demonstrated an anxiety-reducing effect after the administration~     of cortisone before the confrontation with a phobic stimulus in patients with social and~     spider phobia.~   "
113158|NCT01574001|"~     The primary objective of the present randomized controlled trial is to compare the~     effectiveness of three anti-smoking interventions of different intensities. It has been~     hypothesised that early follow-up visits facilitate post-stroke smoking cessation in~     patients hospitalized because of first-ever ischemic stroke.~   "
113159|NCT01573988|"~     In this study, the investigators are interested in assessing the effects of the isocaloric~     increase of eating frequency on appetite and metabolism. How the consumption of an~     isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean~     and obese subjects through :~        -  the physiological consequences : difference in postprandial kinetics of glucose, non~          esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin,~          ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1~          (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde~          (MDA), glutathion, lipid hydroperoxides)~        -  eating behavior during an ad libitum buffet test meal~   "
113160|NCT01573975|"~     The purpose of this study is to compare the eradication efficacy of 10-day triple therapy~     with 10-day sequential therapy with tetracycline or metronidazole.~   "
113161|NCT01575067|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     preformed cuff ranged 22 cm-42 cm.~   "
113162|NCT01575054|"~     This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult~     post-stroke lower limb spasticity.~   "
113163|NCT01575041|"~     To determine the effect of (1) increased sodium intake and (2) increased potassium intake on~     blood pressure, vascular function and renal function in untreated (pre)hypertensive~     subjects.~   "
113164|NCT01575028|"~     This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One~     group of patients will receive a transversus abdominis plane (TAP) block. The second group~     will receive local anesthetic infiltration injected at the surgical site by the surgeon at~     the end of surgery for a laparoscopic appendectomy. The purpose of this study is to~     prospectively compare post-operative pain relief in pediatric patients undergoing~     laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block~     or local anesthetic infiltration by the surgeon for analgesia to compare the most~     appropriate delivery of effective analgesia. In an effort to improve postoperative analgesia~     while limiting opioid-related adverse effects, there continues to be an increased use of~     multimodal techniques in infants and children.~   "
113165|NCT01575015|"~     Patient with liver failure waiting for liver transplantation are often hospitalized and~     commonly supported in an intensive care unit prior to surgery. These patients are sick, and~     in addition to the complications of a failing liver, other organs such as the kidneys often~     fail as well. As a consequence, these patients are at an increased risk for complications~     related to their kidney failure during their liver transplantation procedure. One potential~     method to diminish the risk of these complications is to provide dialysis support to these~     patients during their liver transplantation in the operating theater in the form of~     continuous renal replacement therapy (CRRT). While this is increasingly being performed and~     is theoretically appealing, there is very little information to support this practice. In~     addition, the use of CRRT during surgery is not entirely without risk. The investigators~     have performed two preliminary studies on the use of CRRT during liver transplantation and~     our data would strongly support the need to conduct further higher-quality studies to better~     evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized~     trial comparing the use of CRRT during surgery with standard supportive care in sick~     patients with liver failure scheduled to receive a liver transplantation.~   "
113166|NCT01575002|"~     In this study the investigators aim to examine the effects of Transcranial Direct Current~     Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing~     in individuals with chronic pain of the cornea -- and also compared with healthy controls.~   "
113167|NCT01574989|"~     In this study the investigators aim to investigate the effects of two different types of~     non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation~     (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This~     is a cross-over study where subjects will receive 5 sessions of stimulation (each separated~     by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham~     tDCS and rTMS.~   "
113168|NCT01574976|"~     The purpose of this study is to determine how feedback and practice affect decision making~     in adolescents with attention deficit and hyperactivity disorder.~      Participants will have to choose between low and certain outcome and a higher but uncertain~     outcome, with or without serial feedback after each trial. Participants will perform the~     task twice to examine practice effects.~   "
113169|NCT01574963|"~     Osteoprotegerin (OPG) is membrane bound in the immune system but can also be produced and~     secreted almost everywhere in the organism, so that it is mainly available in soluble form.~     So far, the OPG/RANKL/RANK system has been most intensively studied in bone. The binding of~     RANKL on its receptor RANK, which is expressed by osteoclasts, activates a number of~     osteoclastic cell functions. OPG also has a key function in the vascular system. Patients~     with coronary heart disease (CAD) have elevated OPG serum levels, probably as a sign of~     ischemic or inflammatory endothelial damage. Elevated OPG levels were also found in patients~     with advanced heart failure, whereby OPG correlated with pro BNP (brain natriuretic peptide)~     and was a predictor for cardiovascular morbidity and mortality.~      Our prospective cohort study will include 150 men (75 patients requiring surgery for CAD and~     a control group without coronary heart disease). The primary endpoints are the differences~     between the two groups in serum levels of OPG and RANKL, markers of bone metabolism~     (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH)~     vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to~     vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density. Metabolomic~     based biomarkers will be evaluated to explore the mechanisms behind OPG-RANKL linked CVD~     damage. In the patients further studies of the mRNA expression of OPG, RANKL, TRAP5b,~     arginine:glycine amidinotransferase (AGAT) and osteocalcin in bone (sternum sliver) and~     vascular wall (aorta, internal thoracic artery and the great saphenous vein) will be~     performed.~      A further study endpoint is the analysis of a causal coincidence between osteoporosis and~     CAD and the discrimination of possible key factors in the two entities. These will be~     determined by the correlation between the above-mentioned markers in serum and the~     expression in different vessels and in bone tissue.~      In addition to analysis of the degree of vascular sclerosis, the mineral content of the bone~     will also be analyzed in a subpopulation with quantitative backscattered electron imaging~     (qBEI) related to the degree of vascular sclerosis and bone mineral density. The ultimate~     goal of the analysis is the discrimination of the most sensitive predictive marker(s) for~     diagnosis and outcome of patients with CAD for the purpose of early diagnosis and primary~     prevention of the disease.~      CAD and osteoporosis are increasingly prevalent diseases that overlap. In both entities, OPG~     plays a role not only in pathogenesis but also as an outcome predictor. We aim to study the~     relevance of OPG concentration in serum but also in the vessel wall and the bone.~   "
113170|NCT01574950|"~     Delirium (confusion) after surgery is common and associated with a longer hospitl stay and~     increased hopsital cost. There is very little information available about how often delirium~     occurs and the complications associated with it. Elderly patients are at high risk for~     delirium after surgery. This research is being done to measure how often delirium after~     spine surgery occurs and to see if there are ways to predict if delirium will develop. The~     results from this study will provide important information on a possible mechanism and~     predictor of delirium.~   "
113171|NCT01574937|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for~     use in participants, including people with your type of cancer.~      In this research study, we are testing the safety of XL184 at different dose levels. XL184~     is a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may~     prevent tumor growth by stopping the formation of blood vessels inside the tumor and also~     shrink tumors.~      This drug has been used in early-stage studies and is also currently being studied in other~     trials. Information from those other research studies suggests that XL184 may help to slow~     or stop tumor growth including prostate cancer. We will also be taking blood and urine tests~     to look at how your body processes the drug.~   "
113391|NCT01571986|"~     A single center, observational, prospective study to improve knowledge about non-invasive~     ventilation, obtaining data about compliance, efficacy, imaging in patients who already~     receive non-invasive ventilation as standard of care.~   "
113172|NCT01574924|"~     The Ethics Committee of Hospital and University Center of Coimbra (Portugal) complies,~     reports and is supervisioned by the Portuguese Ethics Committee.~      The Ethics Committee of Hospital and University Center of Coimbra is an multidisciplinary~     organ of Ethics experts that give support to the board of hospital directors, the health~     personnel and patients, regarding bioethical issues emerging from clinical assistance~     activities (addressed to patient's health being, education and clinical research).~   "
113173|NCT01574911|"~     Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The~     objective of this project is the validation of real-time reconstruction and calculation of~     limb volume using a 3D laser scanner.~      Water - displacement volumetry (water-filled boot) is the reference method with known~     accuracy and reproducibility, but is not commonly used in clinical practice because it is~     cumbersome, difficult, and time-consuming. The most commonly used method remains segmental~     limb perimetry with a tape measure, followed by volume calculation using the truncated cones~     formula, thus excluding de facts extremities (hands and feet) which can neither be likened~     to cones nor easily measured.~      Quantification limb volume and volume changes is essential for the diagnosis and follow-up~     of patients with chronic venous insufficiency or lymphedema, two very common pathological~     conditions. It is mandatory for the evaluation of therapeutic approaches.~      The present study will use an innovative technology of volume acquisition by freehand laser~     scanning with a hand-held camera with Quantification limb volume and volume changes is~     essential for the diagnosis and follow-up of patients with chronic venous insufficiency or~     lymphedema, two very common pathological conditions. It is mandatory for the evaluation of~     therapeutic approaches.~      The present study will use an innovative technology of volume acquisition by freehand laser~     scanning with a hand-held camera with real-time 3D reconstruction.~      Its advantages are non-contact, accurate and detailed quantification of edema, including~     extremities, allowing to assess the magnitude and topography of physiological, pathological,~     or treatment - induced volume changes. This approach will ultimately provide data that will~     used for designing personalized limb compression ortheses.~   "
113174|NCT01574898|"~     The purpose of this study is to determine the pharmacokinetic profile of nicotine following~     a single oral administration of three new nicotine lozenge formulations (V0474) in~     comparison with two reference products. The clinical and biological safety of V0474 and the~     lozenge acceptability will also be assessed.~   "
113175|NCT01574885|"~     The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo~     treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at~     least six months.~   "
113176|NCT01574872|"~     The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the~     prognosis of inverse psoriasis or sebopsoriasis present for at least one year~   "
113177|NCT01574859|"~     Retrospective trial of 300 patients with pituitary insufficiency treated in Department of~     Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4)~     replacement and cardiovascular risk factors. The hypothesis is that subtle central~     hypothyroidism is associated with adverse cardiac risk factors, such as body composition and~     serum lipids, and that improved T4 replacement will eliminate this increased risk,~     independently of other pituitary hormone replacements.~   "
113178|NCT01574846|"~     The aim of this non-interventional (observational) study is to document, in collaboration~     with established urologists in Scandinavia, experience gained from routine use of Vantas®~     for the treatment of patients with advanced prostate cancer. In this observational study~     particular attention will be directed to treatment duration, quality of life and patient and~     physician acceptance of the medicinal product for long-term therapy. Patient-based~     measurement parameters such as quality of life and degree of satisfaction will allow~     registration of information that extends beyond the clinical parameters. The knowledge~     gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical~     outcome will also be documented by measuring serum testosterone and prostate specific~     antigen (PSA) levels.~   "
113179|NCT01574833|"~     The investigators hypothesized that early applied pulsed electromagnetic field treatment on~     delayed union might lead to increased rate of fracture union and shortened period of~     treatment.~   "
113180|NCT01574820|"~     Objectives:~      The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial~     for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).~      Background:~      Microvascular and macrovascular complications are common in type 2 DM. There is no evidence~     about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ~     activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory~     process activators) on pre-DM patients with documented CAD.~   "
113181|NCT01574807|"~     The inferior alveolar nerve block (shot) is the most frequently used injection technique for~     achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this~     injection does not always result in successful pulpal (tooth) anesthesia (patient felt~     pain). No study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for~     this type of injection (shot). The investigators propose to compare an injection of~     mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to~     determine if there is a difference in effectiveness.~   "
113182|NCT01574794|"~     The goal of this study is to understand the effects of muscle strengthening and stretching~     exercise intervention on isometric muscle strength, joint flexibility and running~     biomechanical patterns in older recreational runners. To do so, the subjects will be~     assessed before and after they engage in a 8-week exercise intervention program.~   "
113183|NCT01574781|"~     The primary purpose of this study is to collect maternal blood samples from pregnant women~     to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal~     blood.~   "
113184|NCT01574768|"~     The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment~     of snore and OSAS.~   "
113185|NCT01574755|"~     APC of gastric inlet patches is successful for the treatment of globus sensations in the~     throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term~     efficiency of this treatment. To measure long term efficacy all patients treated with this~     therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.~   "
113392|NCT01571973|"~     The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of~     depressed outpatients.~   "
113186|NCT01574742|"~     A single center, open label study assessing the feasibility, safety and therapeutic effect~     of Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients~     diagnosed with unipolar depression that are in a current depressive episode. The patients~     will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and~     have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant~     medications for the duration of the study. All subjects are prescribed minocycline 200~     mg/day orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline~     400 mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary~     objective of this study is to assess the therapeutic effect of Minocycline in unipolar~     depression.~      The secondary objectives of this study are to assess the therapeutic effect, the feasibility~     and safety of Minocycline in unipolar depression.~   "
113187|NCT01574729|"~     The primary objectives of this study are to investigate the efficacy and safety of surgery~     combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma~     (NSCLC). The study efficacy endpoints include overall survival, progress-free survival,~     quality of life, and local recurrent rate. The safety endpoint is complications and adverse~     effects.~      The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the~     local recurrent rate.~   "
113188|NCT01574716|"~     This study is being done to see if MORAb-004 increases the effectiveness of the~     chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.~   "
113189|NCT01574703|"~     Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety~     for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total~     of 52 weeks of cardiovascular safety data collection.~   "
113190|NCT01574690|"~     The purpose of this study is to establish the accuracy of a non-invasive device that uses~     near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to~     physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).~   "
113191|NCT01574677|"~     Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and~     affects men and women almost equally. The United States Preventative Services Task Force~     (USPSTF) currently recommends screening with any of three options, which include fecal~     testing, flexible sigmoidoscopy, or colonoscopy.~      Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually~     or biennially has been shown to decrease mortality 15-33% primarily through detection of~     early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance~     of benefit and risk in screening populations, is the least expensive, and is the preferred~     method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers~     significant improvements over the gFOBT, most notably that it is easier to use (requires~     fewer samples and no dietary or medication restrictions) and is more sensitive than the~     gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved~     test performance and usability, in 2008 multiple professional societies endorsed the use of~     four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the~     OC-Micro FIT as the fecal screening test in all regions.~      In recent years, intensive efforts have been undertaken to identify blood-based markers that~     may provide a promising alternative or supplement to fecal testing for non-invasive CRC~     screening. One method under development is to identify aberrantly methylated genes in cancer~     tissue through a blood test. Prior studies have explored those specific colorectal cancer~     genes that show the highest differences in methylation between the cancer and background~     genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is~     relatively well studied.~      The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement~     the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded~     colonoscopies. The population of interest for this study—those with a positive screening~     OC-Micro fecal immunochemical test—has a CRC prevalence of approximately 5%. Knowing how~     well Septin 9 can identify those without cancer prior to colonoscopy is important largely~     because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can~     cause serious complications.~   "
113192|NCT01574664|"~     The goal of this investigation is to obtain clinical data to show the Health Beacons~     Radiofrequency Identification (RFID) Localization System is safe and performs as intended as~     a localization device for marking and retrieving a non-palpable surgical target from the~     breast.~   "
113193|NCT01574651|"~     This study will assess the efficacy and safety of QVA149 compared to tiotropium plus~     formoterol in patients with moderate to severe COPD.~   "
113194|NCT01574638|"~     This study will evaluate two different ways to give rifapentine (RPT), a drug that may help~     shorten treatment duration for tuberculosis (TB) disease.~   "
113195|NCT01574625|"~     A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of~     patients who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve~     Replacement with a Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate~     the long term safety, efficacy and clinical performance of the Mosaic Bioprostheses.~   "
113196|NCT01574612|"~     To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of~     recurrent cold sores in children ages 6-11yrs after 5 days of treatment.~   "
113197|NCT01574599|"~     The purpose of this study is to assess whether a novel therapy approach (repetitive~     facilitative exercise (RFE)) is more effective than conventional rehabilitation in~     facilitating the recovery of upper extremity function following stroke.~   "
113198|NCT01574586|"~     The primary objective of this study is to make a comparison of safety and efficacy of DESs~     with different link number (2-link Nobori and 3-link Xience) in patients with de novo true~     bifurcation lesions.~      The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE~     rate until one year after PCI will be assessed in both groups.~   "
113199|NCT01574573|"~     By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of~     gastric contents. The investigators hypothesized that the loss of weight will decrease this~     gradient and as a result decrease the severity and frequency of GERD symptoms. GERD~     negatively affects health related quality of life. Since loss of weight may decrease~     gastroesophageal reflux, the investigators hypothesized that it obesity contributes to poor~     quality of life in GERD subjects and losing weight should also favorably impact and improve~     quality of life in GERD patients.~   "
113200|NCT01574560|"~     Smoking is widely accepted to cause an increase in an individual's likelihood of developing~     cancer and heart disease. The effects of tobacco smoke are not limited to smokers.~     Secondhand smoke inhaled by a non-smoker has also been associated with the development of~     several illnesses. This study focuses on learning how to make your home smoke-free.~   "
113201|NCT01574547|"~     This study was designed to: estimate the incidence of cat scratch colon in the investigators~     environment; explore the diseases associated to its development; identify the factors~     related to its development; and assess its clinical repercussions.~   "
113203|NCT01574521|"~     Animal experiments demonstrated that father might transmit HBV vertically via male germ~     line, however, whether it is really existed in human remains to be determined. Since HBV is~     a blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if~     their fetuses carried the virus from fathers. If women had been vaccinated for HBV before~     conception, what would happen to a maternal immune system if her fetus carried HBV from~     spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare,~     the viral replicating status and fetal immune response in uterus are unknown. The aim of~     study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.~   "
113204|NCT01574508|"~     The current study will compare the different efficacy of two transient intensive insulin~     treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily~     insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic~     agents.~   "
113205|NCT01574495|"~     This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that~     leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer~     singles out and magnifies a stroke survivor's movement errors from a desired trajectory,~     thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art~     system which uses haptics (robotic forces) and graphics (visual display) interfaces, a~     subject's desired trajectory can be determined and the movement errors can be amplified in~     real-time with dramatic results. This project evaluates a practical approach of error~     augmentation, using therapist-driven trajectories. The investigators intend to determine~     clinical efficacy of several types of therapist-assisted error augmentation on retraining~     the nervous system in functional activities. The investigators will test two experimental~     treatments in a crossover design. The investigators hypothesize that combined haptic and~     visual error augmentation will lead to the best functional recovery.~   "
113206|NCT01574482|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption~     in mildly hypercholesterolemic people treated or not by statins~   "
113207|NCT01574469|"~     The purpose of this study is to investigate the effect on cholesterolemia profile of a low~     fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in~     mildly hypercholesterolemic people treated or not by statins.~   "
113208|NCT01574456|"~     The main aim of the present study is to improve our understanding of the role of blood-brain~     barrier function in dementia of the Alzheimer's type. The investigators hypothesize that~     microvascular dysfunction - more specifically cerebral perfusion and blood-brain barrier~     leakage - is a determinant of cognitive decline and cortical atrophy in Alzheimer's~     disease.~   "
113209|NCT01574443|"~     The principle aim of this project is to characterize the changes in relative stability of~     the intrinsic brain dynamics during onset of sleep and induction of general anesthesia. The~     investigators hypothesize that brain dynamics in the awake state are critical akin to~     physical systems close to a second order phase transition and that during loss of~     consciousness the dynamics move away from the critical point.~   "
113210|NCT01574430|"~     The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin~     dose in the treatment of CSC.~   "
113211|NCT01574417|"~     Plant sterols and stanols are dietary components that are naturally present in plants. Their~     biological function in plants is comparable with these of cholesterol in animals. They are~     structurally related to cholesterol, but are absorbed by enterocytes to a much lesser~     extent. It is generally accepted that they inhibit intestinal cholesterol absorption and~     consequently lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10%~     at daily intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol~     mediated reduction in intestinal cholesterol absorption is still unknown. It has been~     suggested that they lower the activity of sterol uptake transporters like Niemann-Pick C1~     like 1 protein (NPC1L1) in enterocytes, otherwise several studies indicated that these~     compounds could activate the liver X receptor (LXR) in enterocytes, thereby activating the~     ABC transporters involved in the intestinal cholesterol metabolism, whereas recently~     suggestions have been made that plant sterols and stanols activate transintestinal~     cholesterol excretion (TICE). This is the direct cholesterol secretion from the blood into~     the intestinal lumen, in which the enterocytes play a central role. None of these~     assumptions have so far been evaluated in humans.~      Objective: The major objective of the present study is to examine the acute effects of~     dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal~     biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term~     use (3 weeks) of plant stanol esters have an effect on microbiota composition.~   "
113212|NCT01574404|"~     People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a~     method called preimplantation genetic screening (PGS) before they are implanted in the~     uterus to possibly increase their chances of having a successful pregnancy. One or more~     cells are removed from the embryo. The chromosomes inside the cells are then tested to~     identify normal or aneuploid embryo(s).~      The investigators propose to evaluate a test called micro array analysis on the chromosomes~     of the first polar body. This method tests part of the egg that would normally be lost and~     may help us choose the embryo most likely to become a healthy baby.~   "
113213|NCT01574391|"~     The purpose of this study is to determine whether the use of the Epidrum device to identify~     the epidural space in labouring parturients reduces morbidity, when compared to standard~     loss of resistance techniques.~   "
113214|NCT01574378|"~     VLock suture studied in abdominal wound closure. Time and cosmesis was studied~   "
113215|NCT01574365|"~     A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes~     mellitus.~   "
113241|NCT01573949|"~     The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will~     assess the use of the medication metformin to improve quality of life, exercise capacity,~     and improved outcomes in heart failure patients with pre-DM or early DM (type II).~      If the patient participates in this study, the patient will receive the drug metformin for~     approximately 3 months. During the study the patient will undergo comprehensive testing~     which includes blood draws and echocardiograms. The patient will also fill out a~     questionnaire. The patient must be 18 years old to participate.~   "
113216|NCT01574352|"~     Strong and consistent evidence have shown that overweight, including obesity, is an~     important risk factor for the development of cardiovascular disease (CVD) in adults. Several~     studies have found an association between overweight in childhood and increased risk of~     morbidity and mortality later in life. The prevalence of overweight in children and~     adolescents has increased in recent years, and consequently it is important to identify~     effective approaches in the prevention and treatment of overweight in young individuals.~      Approaches such as resident weight loss camps have shown promising results. A residential~     camp setting provides an opportunity to increase and control exposure to, for instance,~     particular foodstuffs, beverages and physical activity opportunities. However, well-designed~     studies with sufficient participants are still needed on the reversal of overweight in~     childhood with increased focus on documenting predictors of behavior changes associated with~     decreases in overweight.~      This study is carried through as a randomized controlled trial which investigates the effect~     of participating in a 6 week health promoting resident for overweight fifth grade children~     camp followed by 42 weeks of family support.~      The study hypothesis is that participating in a 6 week resident camp and a following period~     of 42 weeks of child and family support will induce a reduction in body mass index (BMI). In~     addition it is expected that the intensity and duration intervention program is sufficient~     to cause changes in physiological parameters related to a reduced risk of lifestyle~     diseases.~   "
113217|NCT01574339|"~     The EndoStim LES Stimulation System is an investigational device intended to improve the LES~     pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from~     Gastroesophageal Reflux Disease (GERD).~   "
113218|NCT01574326|"~     Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to~        -  Evaluate the safety and tolerability of sevelamer carbonate~        -  Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus~   "
113219|NCT01574313|"~     Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for~     years. However, objective evidence of the effect of SGB was still lack. The investigators~     conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of~     electrocochleography (ECoG).~   "
113220|NCT01574300|"~     The purpose of this study is to facilitate application of the known biomarkers to patients~     presenting today, and to establish a collection of biospecimens that will be useful for~     discovering and validating new biomarkers for future use.~   "
113221|NCT01574287|"~     Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a~     small growth called an adenoma in the parathyroid glands) is an increasingly significant~     medical and public health condition.~      Surgery is the only effective management for primary hyperparathyroidism. However; it is~     sometimes difficult to pinpoint the adenoma, in part because current methods of imaging~     often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative~     parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an~     even greater role. Unfortunately current multiple imaging methods fail to localize 10-15%~     these of tumors.~      SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing~     the tumor. This, however, is a challenge because the parathyroid glands usually are located~     close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and~     parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the~     parathyroid but not in the thyroid.~      A more sensitive and specific radiotracer/tracking agent would markedly improve the~     investigators ability to identify parathyroid tumors preoperatively, and thus offer more~     patients a minimally invasive parathyroidectomy.~      anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in~     detecting a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown~     uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think~     that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc~     sestamibi.~      The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates~     uptake within parathyroid adenomas. 12 patients with a diagnosis of primary~     hyperparathyroidism will undergo PET-CT using anti-3-[18F]FACBC in addition to the standard~     99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound,~     MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery~     routinely, the investigators will then compare findings at surgery to those of the~     anti-3-[18F]FACBC PET-CT to determine if this radiotracer is worthy of further study in a~     more comprehensive experiment.~   "
113222|NCT01574274|"~     This study is being conducted to learn about the effects of SC-PEG, which is a new form of a~     chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic~     lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a~     week for 30 weeks. There are other forms of asparaginase. The investigators will be studying~     two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously~     studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with~     ALL, and have shown that this dosing did not lead to any more side effects than Elspar given~     weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar.~     SC-PEG has been given in the vein to children and adolescents with ALL as part of other~     research studies, and it appears to last longer in the blood after a dose than Oncaspar. It~     has not yet been approved by the FDA. The goal of this research study is to learn whether~     the side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to~     Oncaspar given into the vein about every 2 weeks.~      The study will also help to determine whether changing treatment for children and~     adolescents with ALL with high levels of minimal residual disease may improve cure rates.~     Measuring minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells~     that the investigators cannot see under the microscope. In the past, it has been shown that~     children and adolescents with ALL with high levels of MRD after one month of treatment are~     less likely to be cured than those with low levels of MRD. Therefore, on the study, the bone~     marrow and blood at the end of the first month of treatment will be measured in participants~     with leukemia, and changes in therapy will be implemented based on this measurement. It is~     not known for sure that changing treatment will improve cure rates. MRD levels can only be~     measured if the marrow is filled with cancer cells at the time of diagnosis. Therefore, MRD~     studies will only be done in children and adolescents with ALL and not in those with~     lymphoblastic lymphoma.~      Another part of the study is to determine whether giving antibiotics during the first month~     of treatment even to participants without fever will prevent serious infections in the blood~     and other parts of the body. About 25% of children and adolescents with ALL and~     lymphoblastic lymphoma who receive standard treatment develop a serious blood infection from~     a bacteria during the first month of treatment. Typically, antibiotics (medicines that fight~     bacteria) are given by vein only after a child with leukemia or lymphoma develops a fever or~     have other signs of infection. In this study, antibiotics will be given by mouth or in the~     vein to all participants during the first month of treatment, whether or not they develop~     fever.~      Another goal of the study to learn how vitamin D levels relate to bone problems (such as~     broken bones or fractures) that children and adolescents with ALL and lymphoblastic lymphoma~     experience while on treatment. Some of the chemotherapy drugs used to treat ALL and~     lymphoblastic lymphoma can make bones weaker, which make fractures more likely. Vitamin D is~     a natural substance from food and sunlight that can help keep bones strong. The~     investigators will study how often participants have low levels of vitamin D while receiving~     chemotherapy, and, for those with low levels, whether giving vitamin D supplements will~     increase those levels.~      Another focus of the study is to learn more about the biology of ALL and lymphoblastic~     lymphoma by doing research on blood, bone and spinal fluid bone marrow samples. The goal of~     this research is to improve treatment for children with leukemia in the future.~   "
113223|NCT01574261|"~     Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The~     aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk~     factors in PCOS patients.~   "
113224|NCT01574248|"~     Individuals with heart disease or high blood pressure are often prescribed angiotensin~     converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE~     inhibitors can be associated with angioedema, a rare but life-threatening condition that~     causes swelling of the face and other body parts. This study will evaluate the effectiveness~     of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who~     develop the condition.~   "
113225|NCT01574235|"~     The main aim of the study is to assess the safety of Nivestim® treatment in patients treated~     with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant~     hemopathy.~   "
113226|NCT01574222|"~     The purpose of this study is to determine the dose that the vaccine can be given safely to~     patients when injected directly into the lung tumor, without any serious side effects.~   "
113227|NCT01574209|"~     It is well known that the intestinal barrier is altered in celiac disease (CD), an~     autoimmune disease that develops in genetically predisposed subjects exposed to ingestion of~     wheat gliadin and of related prolamines of barley and rye. More recently, defective~     epithelial barrier has been implicated in the pathogenesis of other conditions such as~     irritable bowel syndrome (IBS). At present IBS is still considered a functional condition~     although low-grade inflammation has been associated with its manifestation, particularly~     that following infection. Different substances have been implicated in the (dis)regulation~     of intestinal barrier, among them zonulin seems to play a key role. Other gastrointestinal~     peptides are GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on~     the hormonal regulation of intestinal barrier function in celiac patients before undergoing~     a gluten free diet and possible differences with those of IBS patients, in the present study~     the investigators will apply the non-invasive lactulose/mannitol permeability test toward~     the evaluation of intestinal damage. The pattern of intestinal permeability and the GI~     peptides concentration will be compared in celiac patients, IBS patients and healthy~     controls.~   "
113315|NCT01572974|"~     To Compare the overall quality of life of patients with no Barrett's esophagus ,~     non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia~     (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall~     quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease~     (GERD) symptoms to those with no GERD symptoms~   "
113228|NCT01574196|"~     The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en~     Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne)~     coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at~     re-examining, in their initial treatment center, all patients (a cohort of 495 patients~     alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except~     leukemia) in the Rhône-Alpes and Auvergne regions.~      The rationale for this study is based on the observation that although the survival rate of~     childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are~     high and greatly increase the risk of mortality in later years (estimated to be 14% in the~     literature).~      The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the~     activity of the intrinsic cardiac autonomic regulation, which represents a powerful~     predictor of cardiovascular morbidity to the individual.~   "
113229|NCT01574183|"~     Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated~     pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy~     of vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency~     management intervention (CM)and motivational enhancement therapy (MET)will be incorporated~     to encourage study engagement and retention, and genomic DNA will be extracted to~     characterize subjects according to polymorphisms of genes potentially relevant to the~     activity of vilazodone. It is hypothesized that vilazodone combined with MET and CM will~     reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent~     individuals as compared to a placebo treatment combined with MET and CM.~   "
113230|NCT01574170|"~     This is a biomedical study of interventional type. The trial will include 270 patients (180~     patients in the first cohort and 90 patients in a second cohort) over a period of 3 years +~     2 years of follow up.~      This prospective study will be conduct in patients who will receive a third line~     chemotherapy for metastatic breast cancer.~      The main objective of the study (first cohort) is to identify patients who benefit from a~     third line treatment in terms of overall survival with a score established from clinical,~     histological, but also biological classic and innovative (account of circulating tumor~     cells) criteria, all of these criteria must be measurable before the introduction of the 3rd~     line.~      This score will then be validated on the 2nd cohort.~      There will be no interruption of inclusions between first and second cohort of patients~   "
113231|NCT01574157|"~     The purpose of this study is to see if treatment with sodium bicarbonate will lower urine~     levels of proteins that are indicators of kidney damage in people with diabetes who also~     have chronic kidney disease.~   "
113232|NCT01574144|"~     The purpose of this observational study is to collect and characterize multiple physiologic~     data from a broad subset of subjects with acute heart failure (HF)~      Changes in physiologic data are expected to correlate with 30-day readmission rates in this~     population~   "
113233|NCT01574131|"~     The purpose of this study is to learn the following: whether long-term treatment (6 months)~     with fenofibrate will decrease burn related sugar and fat increased in the blood and help~     prevent muscle loss and improve wound healing.~   "
113234|NCT01574118|"~     This study is investigating a new brief psychotherapy for post-traumatic stress disorder~     (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components~     and modifying several others. The goal of the study is to determine whether this~     experimental treatment outperforms the well-established standard treatment.~   "
113235|NCT01574105|"~     Blood is anticoagulated using a drug named heparin during open-heart surgery to allow it to~     safely pass through the heart-lung machine which pumps the blood throughout the body during~     the surgery. Each patient is given the heparin they need for their surgery. This means some~     patients receive more or less heparin than other patients. In this study, the investigators~     will be evaluating the current anticoagulation protocol for open heart surgery in use at the~     Royal University Hospital. The goal of this project is to compare patients who require and~     receive more heparin for proper anticoagulation to those patients who require and receive~     less heparin.~      Open-heart surgery will proceed according to the standard hospital protocol. All research~     participants will be treated according to standard post-open heart surgery protocol in the~     ICU. This will include measurement of blood loss by keeping track of chest tube outputs and~     administration of blood transfusions.~      This study focuses on Saskatoon Health Region patients having open heart surgery in terms of~     the protocol for anticoagulation and blood transfusions.~   "
113236|NCT01574092|"~     Tumours of the brain and of the central nervous system (CNS) are the most common solid~     tumours in children. Amongst these, gliomas are the most frequent, although this term covers~     different histological subtypes, the most frequent being astrocytoma. However, they are rare~     diseases of low prevalence.~      The interest in the cisplatin/irinotecan combination in brain tumours motivated a previous~     pilot study at our hospital, with encouraging results. This experience, together with the~     need for new strategies for high-risk pediatric gliomas has motivated the conduct of this~     study.~   "
113237|NCT01574079|"~     Mirror therapy may be an effective intervention in increasing motor control and gait~     performance in patients with stroke.~   "
113238|NCT01574066|"~     Primary objective : to estimate impact of CT-scan on diagnostic for emergency department~     (ED) patients with suspected Community-acquired Pneumonia (CAP).~      Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and~     site of care for ED patients with suspected CAP.~   "
113239|NCT01574053|"~     Enroll-HD is a longitudinal, observational, multinational study that will integrate two~     existing Huntington's Disease (HD) registries, REGISTRY in Europe and COHORT in North~     America and Australia, while also expanding to include sites in Latin America and Asia. With~     no end date and annual assessments, the goal of Enroll-HD is to build a large and rich~     database of longitudinal clinical information and biospecimens. This database will serve as~     a basis for future studies aimed at developing tools and biomarkers for progression and~     prognosis, identifying clinically relevant phenotypic characteristics, and establishing~     clearly defined endpoints for interventional studies.~   "
113240|NCT01573962|"~     The objective of this sample collection study is to collect blood and urine samples. This~     study is observational and will have no impact on the medical management of the subject.~   "
113242|NCT01573936|"~     The purposes of this study were to evaluate the influence of an interdisciplinary~     rehabilitation program in the improvement of the health-related quality of life among adult~     neurological patients and to identify the sociodemographic and clinical associated~     characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis~     survivors participated in the study. All participants underwent a rehabilitation program~     (RP) from January 2008 through July 2010, which consists of 40-minutes of many therapies for~     1-2 days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.~   "
113243|NCT01573923|"~     Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality~     worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel~     therapies are necessary to prevent or block the process of the disease. In this current~     prospective cohort, the investigators plan to organize four hospitals to determine the~     safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the~     treatment of patients with liver cirrhosis in next three years.~   "
113244|NCT01573910|"~     The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the~     treatment of bacterial conjunctivitis in Chinese patients.~   "
113245|NCT01573897|"~     Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low~     transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor~     for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and~     sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing~     the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2~     between the end of the night and midday in patients with -or at risk of- diabetic foot wound~     according to the presence or not of sleep apnea syndrome.The secondary objective is to~     address the microvascularisation of diabetic patients having foot wounds according to their~     status regarding sleep apnea syndrome.~   "
113246|NCT01573884|"~     -  Exploratory analyses of the immune response in a ex vivo culture system~        -  Characterization of the composition of maternal milk and infant urine~   "
113247|NCT01573871|"~     The objective of the study is to assess gastrointestinal tolerance and compliance in infants~     who require a hydrolyzed formula.~   "
113248|NCT01573858|"~     The objectives of the present trial are to test the following three hypotheses in~     anovulatory women with PCOS:~        1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than~          acupuncture protocol 2 combined with CC (Arm B),~        2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than~          acupuncture protocol 1 plus placebo (Arm C),~        3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than~          acupuncture protocol 2 plus placebo (Arm D).~   "
113249|NCT01573845|"~     The central hypothesis of The GREEN Project Lunch Box Study is that a school-based~     communication campaign that combines healthy eating and eco-friendly messages will improve~     the quality of foods that children bring from home to school more than a healthy eating~     campaign alone and compared to a control/delayed intervention condition at the end of one~     school year.~   "
113250|NCT01573832|"~     This study will use a randomized control trial design to compare wound care clients who~     receive integrated care versus usual care in Community Care Access Centres (CCAC) in~     Ontario. Data will be collected by existing administrative databases and linked by the~     Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these~     databases and report findings.~   "
113251|NCT01573819|"~     The study drug, GSK356278, is a possible new medicine for the treatment of Huntington's~     disease. Huntington's disease, which is often called HD, is caused by a faulty gene that is~     passed down through families. HD causes damage to nerve cells in the brain which causes them~     to waste away. As the damage progresses patients develop symptoms that affect every aspect~     of life. HD reduces people's ability to walk, talk, think, communicate and causes~     uncontrolled movements. GSK356278 may slow down the progression of damage to nerve cells in~     people with HD and help with their ability to think.~      GSK356278 was well tolerated when it was given as a single dose to healthy people. In this~     study we want to see what effects, both good and bad, GSK356278 has in people when it is~     taken every day. During the study we will look at about 3 different doses of GSK356278 in~     about 36 healthy people. The study will also look at how GSK356278 tablets behave in the~     body after it is swallowed (this is called pharmacokinetics). The study will also look at~     effects of GSK356278 on the body (this is called pharmacodynamics). The study will help to~     design future clinical studies with GSK356278.~   "
113252|NCT01573806|"~     Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will~     examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of~     four does of exenatide injected every 12 hours to children with shock from infection (septic~     shock). The investigators hypothesize that exenatide can be safely dosed to children with~     sepsis to achieve blood levels of drug similar to that achieved in teenagers with type 2~     diabetes. The investigators further hypothesize that injection of exenatide to children with~     septic shock will normalize blood glucose levels and decrease levels of inflammation~     proteins in the blood during the early course of sepsis.~   "
113253|NCT01573793|"~     The purpose of this study is to determine if providing parenting education materials~     delivered in different ways during the first 30 months of a child's life will increase~     child-parent attachment and promote mother-child interaction, if certain types of strategies~     improve cognitive, language, and emotional development in infants and toddlers, and if our~     way of delivering these materials is cost-effective.~   "
113254|NCT01573780|"~     The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and~     tolerated when given with gemcitabine hydrochloride to patients with advanced cancer~   "
113304|NCT01573117|"~     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac~     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain~     swelling associated cerebrovascular disease. The narrow-time-frame is a major issue (time~     is brain). To provide immediate cooling without delay, easy to use, mobile and effective~     methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill~     (BeneChill, USA) is a new device. A comparison of these two induction methods has never been~     done before. Neither was the effect of cold infusions on brain-temperature measured. For the~     first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.~   "
113255|NCT01573767|"~     This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group,~     placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma.~     Subjects entering the run-in period will stop their current asthma medication and be given~     open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and~     salbutamol/albuterol as required to use throughout the run-in and double-blind treatment~     period. At Visit 3 subjects meeting the randomization eligibility criteria will receive~     vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI)~     once daily for 4 weeks in addition to open-label fluticasone propionate twice daily~     throughout the treatment period. Primary endpoints consist of change from baseline in clinic~     visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period~     in all subjects. Safety assessments include adverse events, oropharyngeal examinations,~     clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all~     subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at~     specific time intervals relative to the dose of study drug.~   "
113256|NCT01573754|"~     Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by~     phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are~     limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of~     time to remission. Patients with well documented PCT are assigned to treatment by~     randomization if specific criteria are met. All patients are followed until remission -~     defined as achieving a normal plasma porphyrin concentration.~   "
113257|NCT01573741|"~     Primary Outcome Measures:~      Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.~      Secondary Outcome Measures:~      Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in~     psychiatric symptoms, and suicidal ideation.~   "
113258|NCT01573728|"~     The pilot project proposed here will establish the feasibility and preliminary data~     necessary to test in a subsequent randomized trial: 1) whether independent of social~     contact, aerobic exercise training is effective in the treatment of depression and 2)~     whether changes in biological markers indicate an anti-inflammatory process, neurogenesis~     process, or both as a result of exercise. Target participants are adults aged 46 years or~     over who have current minor to moderate depressive symptoms.~      This pilot is a three-arm design of low dose exercise versus public health dose exercise~     intended to: 1) establish the feasibility, acceptance, and safety of Internet-based~     supervised exercise training and 2) obtain retention and attendance estimates needed to~     determine sample sizes for the follow-up trial.~   "
113259|NCT01573715|"~     Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical~     ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a~     prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular~     blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et~     al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could~     improve survival remain speculative. They are as follows:~        -  reduction of the consumption of oxygen linked to ventilatory workload;~        -  increase of chest wall compliance improving mechanical ventilation during ARDS and~          better adaptation to the protective ventilation strategy;~        -  anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and~          improvement in oxygenation,~        -  reduction of the variations of transpulmonary pressure (TPP) by the way of better~          synchronisation between patient and the ventilator.~      The use of NMBA could also reduce the ventilator induced lung injury by a better control of~     TPP.~   "
113260|NCT01573702|"~     - Progression free survival after locally ablative therapy and erlotinib in EGFR patients~     progressed after EGFR-TKI therapy~   "
113261|NCT01573689|"~     The methodology of this clinical trial is based on the realisation of a group intervention~     with children who lost a parent. Interviews preintervention and postintervention with~     participants will be done as well. The purpose of this study is to answer the following~     question: What are the benefits for children who are in the process of bereaving a parent~     to participate in a group work intervention based on the mutual aid model ?. The aim of the~     research is to explore the benefits for grieving children to participate in an group work~     intervention based on the mutual aid model. To do so, the research has three distinct~     objectives : 1) to develop and apply a program of group work interventions for grieving~     children based on the mutual aid model ; 2) to explore the extent to which participation in~     the group facilitates changes in the children's discourse about death and the loss of their~     parents, and 3) to examine, from the children's own perceptive, the possible impact that~     their participation in the group have on their experience of bereavement.~   "
113262|NCT01573676|"~     Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep~     breathing disorders in patients with extreme BMI.~      Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The~     characteristics of patients with sleep apnea that were evaluated for bariatric surgery and~     had a full overnight polysomnography (PSG) screening for OSA were described and it was found~     that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of~     pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.~      The investigators would like to demonstrate the impact of bariatric surgery on OSA as a~     function of time.~   "
113263|NCT01573663|"~     The purpose of this study is to evaluate the drug-durg interaction between ambroxol and~     levodropropizine.~   "
113264|NCT01573650|"~     1. To analyse the outcome of different treatment options of peripheral nerve repair with~          no gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize~          peripheral nerve repair~        2. To reduce morbidity with the same outcome~   "
113265|NCT01573637|"~     The efficacy of raloxifene versus placebo was compared over a six-month period, as an~     adjuvant treatment of the negative symptoms of schizophrenia in a group of 80~     post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect~     on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms~     in general, and on social and neuropsychological functioning, and to study the influence of~     genetic polymorphisms in treatment response.~   "
113314|NCT01572987|"~     This clinical trial will evaluate a patient population with Barrett's esophagus(BE)~     containing high grade dysplasia or intramucosal cancer and compare the effects of~     endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise~     endoscopic mucosal resection(S-EMR).~   "
113266|NCT01573624|"~     Brief Summary: The purpose of this study is to characterize the dose response of GSK573719~     in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with~     inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active~     control.~      Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic~     bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms~     on large and small airways. Most of the experience with older anti-cholinergics had been~     with acute use and little is known about their effect in chronic use in asthma. This is a~     multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled~     GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and~     Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each~     eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3~     treatment periods per subject. The total duration of subject participation is approximately~     14 weeks.~   "
113267|NCT01573611|"~     Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and~     anticarcinogenic properties. In the past decade, there has been emerging evidence regarding~     a potential role for grapes in slowing cognitive decline and other effects of aging.~     Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape~     seed extract improves cognitive performance. Despite the promising accumulating data~     supporting the use of grapes as a safe and effective strategy for delaying the incidence of~     dementia, it remains unclear how grape intake would be useful with respect to factors such~     as dose schedule or stage of dementing illness. In general, well-controlled experimental~     data obtained in human subjects is in need of much further development. The investigators~     aim to measure effects of grape intake on cerebral metabolism and cognitive function, and to~     determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed~     by positron emission tomography (PET) can serve respectively as a predictor of, and~     biomarker for, the magnitude of cognitive changes resulting from intake of grapes.~   "
113268|NCT01573598|"~     Safety and Efficacy of Vilazodone in Major Depressive Disorder~   "
113269|NCT01573585|"~     The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping~     Training) exercises will improve walking balance in individuals after stroke to a greater~     extent than usual care.~      Hypothesis: The primary hypothesis is that improvements in walking balance will be larger~     following 12 sessions of FAST exercise retraining compared to usual care in persons in the~     sub-acute phase after stroke.~   "
113270|NCT01573572|"~     Due to the lack of information generated in the pivotal phase III trials assessing potential~     effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal~     endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study~     to support that there are no adverse effects on the corneal endothelium following~     intravitreal injections of Macugen.~   "
113271|NCT01573559|"~     This study serves as a comparison study between the EPIC ClearView and a predicate device.~   "
113272|NCT01573546|"~     ENLIGHTEN will examine the effects of exercise, the dietary approaches to stop hypertension~     diet (DASH), and a combined exercise and DASH intervention on cognitive function among~     adults with cardiovascular disease (CVD) risk and cognitive deficits. Participants will be~     randomized to one of the three treatments, or a health education control condition, for 6~     months, and will complete assessments of CVD health and cognitive function before and after~     treatment.~   "
113273|NCT01573533|"~     The purpose of this study is to determine whether Rituximab therapy is safe and effective in~     treating patients with the kidney condition, focal segmental glomerulosclerosis (FSGS), that~     is no longer responsive to traditional therapies.~   "
113274|NCT01573520|"~     Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients~     is cumbersome, partly due to patient's non-adherence to prescribed drugs.~      The main objective of this study was to assess whether an integrated care (IC) approach, in~     which adherence data are integrated in the decisional process, led to improved therapeutic~     control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as~     compared to a usual care (UC) approach, in which biological values represent the main stem~     of the decisional process.~      The predefined hypothesis was that patients of the IC group should reach the iPTH targets~     using 25% less doses of cinacalcet at 6 months than those of the UC group.~   "
113275|NCT01573507|"~     Background: Although glucose is essential to cerebral function, abundant experimental and~     clinical evidence demonstrates that endogenously released lactate, rather than glucose, is~     the preferential energy substrate for the brain in conditions of stress and acute injury. In~     patients with severe Traumatic Brain Injury (TBI) and aneurysmal subarachnoid hemorrhage~     (SAH) monitored with cerebral microdialysis and brain tissue oxygen (PbtO2), our preliminary~     data show that increased brain extracellular lactate is frequently observed. Our findings~     indicate that elevated brain lactate more often occurs in the absence of brain~     hypoxia/ischemia and is mainly the consequence of increased cerebral glycolysis, i.e. it~     occurs in association with high extracellular pyruvate. These data suggest that the primary~     source of elevated lactate is activated glycolysis and strongly support the concept that~     endogenously released lactate can be utilized by the injured human brain as energy~     substrate. They prompt further investigation to examine whether exogenous lactate~     supplementation can be a valuable neuroprotective strategy after TBI or SAH. Indeed, in~     animal models of brain injury, administration of exogenous lactate improves neuronal and~     cognitive recovery.~      Hypothesis: The investigators test the hypothesis that lactate therapy, administered during~     the acute phase of TBI or SAH, might exercise neuroprotective actions by restoring brain~     energetics and improving brain tissue PO2 and cerebral blood flow (CBF).~      Aim of the study: The aim of this single-center study is to examine the effect of sodium~     lactate infusion on cerebral extracellular metabolites, brain tissue PO2 and cerebral blood~     flow, measured with CT perfusion and transcranial doppler (TCD).~      Design: Prospective phase II interventional study examining the effect of a continuous 3-6~     hours infusion of sodium lactate (20-40 µmol/kg/min), administered within 48 hours from TBI~     or SAH, on cerebral extracellular glucose, pyruvate, glutamate, glycerol, PbtO2 and CBF.~   "
113287|NCT01573338|"~     This is the first study where BAY1000394 is given in combination with chemotherapy:~     cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will~     be treated. Every patient will receive drug treatment, there is no placebo group. Different~     groups of patients will receive different dosages of BAY1000394 to determine the safety and~     maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of~     chemotherapy is the standard dose usually administered and will not change.~      The study will also assess how the drug is metabolized by the body and changes in tumor~     size.~      BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will~     stop if the tumor continues to grow, if side effects occur which the patient can not~     tolerate or if the patients decides to exit treatment.~   "
113288|NCT01573325|"~     The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a~     single center for those who are pre-liver transplant candidates~   "
113276|NCT01573494|"~     Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as~     a prognostic factor and predictor of therapeutic response. The detection of CTC by~     immunomagnetic method has proved its reliability and its usefulness for monitoring breast~     cancer, colon and prostate in the metastatic and immunomagnetic detection system~     (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date~     there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR~     amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new~     detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United~     States). This system has the advantage of combining immunomagnetic selection step and a step~     of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma~     cells has shown encouraging results. The investigators propose a prospective study of the~     CellSearch system in patients with melanoma.~      Primary objective: To determine the effect of treatment on the number of circulating~     melanoma cells in patients with metastatic melanoma.~      Secondary objectives:~        -  determine the percentage of patients with metastatic melanoma with melanoma cells~          circulating~        -  seek a relationship between the number of circulating melanoma cells and prognosis in~          patients with metastatic melanoma~        -  seek a relationship between the change in the number of circulating melanoma cells~          before / after treatment and tumor response in patients with metastatic melanoma~   "
113277|NCT01573481|"~     The purpose of the study is to compare pressure controlled continuous mandatory ventilation~     versus pressure support ventilation during the night for weaning to mechanical ventilation~     in chronic obstructive pulmonary disease patients and their impact onto sleep quality.~   "
113278|NCT01573468|"~     This study is being performed to evaluate the efficacy and safety of capecitabine in~     combination with tesetaxel versus capecitabine in combination with placebo as second-line~     treatment for patients with gastric cancer.~   "
113279|NCT01573442|"~     This randomized phase III trial studies testosterone to see how well it works compared to~     placebo in treating postmenopausal patients with arthralgia (joint pain) caused by~     anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia~     associated with the use of aromatase inhibitors, such as anastrozole or letrozole.~   "
113280|NCT01573429|"~     Background:~      - Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and~     thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and~     water from plastic products, including water and baby bottles. However, not all of the risks~     of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the~     body gets rid of BPA.~      Objectives:~      - To study controlled exposure to BPA and its effects on the body.~      Eligibility:~      - Healthy, non-obese volunteers between 25 and 45 years of age.~      Design:~        -  Participants will have five visits over about 2 to 4 weeks for this study.~        -  At the first visit, participants will be screened with a physical exam and blood and~          urine tests. They will complete a questionnaire about exposure to BPA-containing~          products. They will also receive a list of medications that should not be taken during~          the study period.~        -  The second visit will last about 13 hours. Participants will fast for 8 hours before~          the visit. They will then have a single dose of d-BPA (a modified form of BPA that is~          easier to study in the body). Regular blood samples will be taken over the 13-hour~          visit. All urine will also be collected. Participants will receive breakfast and lunch~          during the visit.~        -  Participants will have three follow-up visits. They will collect and store all of their~          urine between each follow-up visit. Blood samples will be collected at the follow-up~          visits.~   "
113281|NCT01573416|"~     Alcohol and drugs consumption are among the highest risk factor for health in Chile and~     abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden~     of disease while lost years of healthy life are higher than many other risk factors such as~     hypertension, overweight and obesity, and hyperglycemia. It is important to say that the~     impact of alcohol consumption is greater in younger age groups where fatal injuries occur~     relatively early in life, as well.~      In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the~     last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even~     greater in young adults and adolescents and is associated with other mental health issues~     and poorer life quality. Those who have consumed marihuana during the last year, 25% report~     dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers.~     This data reinforce the need to design and implement strategies for reducing alcohol and~     drugs consumption in our population.~      Also, it is well known that a high number of those who suffers from any addiction problem do~     not get attention in a specialized center. The are many barriers to do so, such as lack of~     motivation, lack of resources, social problems, access to care problems, and so on.~      Chile has a shortage of preventive interventions for those at risk to develop an addiction~     at an early stage of substance use because front line health services (Primary health care~     and emergency care) and other social services (police stations, local justice courts) do not~     have a screening system and a model of brief intervention.~      The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC)~     and its Department of Family Medicine, is working in conjunction with SENDA (Servicio~     Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design,~     implement and evaluate a communal system for early detection, brief intervention and~     referral to treatment (SBIRT), in people older than 18 years, with substance consumption in~     five municipalities in the country.~      The aid of this study is to demonstrate that a model of brief intervention is more effective~     than the approach currently used in patients with substance use at moderate risk~     (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a~     group to receive brief intervention and a control group that is kept in control and waiting~     list being re-evaluated three months later.~      The target population is composed by users whose ASSIST screening scores place them in the~     moderate risk group, for which there has not been defined a structured intervention yet by~     our health system. The information will be obtained from the scores obtained after the~     application of the ASSIST-WHO questionnaire.~   "
113282|NCT01573403|"~     This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical~     study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation~     as well as its safety in healthy volunteers.~      DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is~     hypothetically more potential than PPIs in suppressing gastric acid as our previous~     preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+~     ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression.~     It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.~   "
113283|NCT01573390|"~     1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system~        2. Quantitative validation of non-contact vascular function imaging by the CWC imaging~          system~        3. Evaluation of the clinical usability of the CWC imaging system for further technology~          development and engineering improvement~   "
113284|NCT01573377|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in~     reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed~     menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might~     become the patients with impaired glucose tolerance or type 2 diabetes. It has been~     confirmed that insulin resistance (IR) is a common feature in PCOS and adipokines might play~     roles in the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects~     on carbohydrate and lipid metabolism.~      The present clinical trial intends to compare the effects of metformin and oral~     contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and~     menstrual cycle etc. The investigators also aim to study the effects of metformin on serum~     adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS~     patients.~   "
113285|NCT01573364|"~     The aim of this observational study is to evaluate the pulmonary hyperinflation and its~     immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent~     asthmatic patients with dyspnea.~   "
113286|NCT01573351|"~     The purpose of this study is to assess efficacy, as determined by the proportion of subjects~     with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C~     virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.~   "
113302|NCT01573143|"~     The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether~     perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial~     fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing~     elective cardiac surgery.~   "
113303|NCT01573130|"~     The purpose of the study is to investigate the effects of an internet-administered,~     therapist-assisted physical exercise program for the treatment of depression.~   "
113289|NCT01573312|"~     This is a single center, randomized, double-blinded, controlled, Phase I, small targeted~     prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old,~     inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an~     intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005)~     virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or~     without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses~     administered 28 days apart. This study will use a systems biology approach to assess the~     human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first~     vaccination. The systems data will be integrated with immunogenicity and reactogenicity data~     to develop a systems model of the human immune response to A/H5N1 vaccine with or without~     AS03 adjuvant.~   "
113290|NCT01573299|"~     Even if it is a daily questioning for the stroke physician, no concrete recommendation~     exists regarding the time-point of the mobilization of stroke patients. In this study, we~     will compare two mobilisation strategies: early versus delayed verticalisation. 400~     ischemic stroke patients will be included in this prospective randomized controlled trial,~     equally distributed in two groups. In the early mobilisation procedure the patient is~     allowed to go and sit outside of the bed the day after the stroke onset, whereas in the~     other arm, this procedure is delayed to the third day after stroke onset. The outcome in~     both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly~     used in stroke study to investigate the functional outcome of the patients.~   "
113291|NCT01573286|"~     This protocol outlines a randomized,open label trial examining the safety, pharmacology and~     efficacy of Glucagon like peptide 2 (GLP-2) in infants and children with intestinal failure.~     The investigators hypothesize that GLP-2 given subcutaneously in these patients will be well~     tolerated, and have similar metabolism to what has been shown in adults. The investigators~     also expect to show an improvement in the tolerance of enteral nutrition, and a decreased~     requirement for intravenous feeding.~   "
113292|NCT01573273|"~     Stress is likely involved in relapse to cocaine use. This project will investigate the role~     oxytocin may play in the stress response in cocaine-dependent men and women and examine how~     oxytocin may impact brain activity in individuals exposed to cocaine-related cues.~   "
113293|NCT01573260|"~     Parkinson's disease involves many motor difficulties as well as non-motor ones. Recent~     research has strongly suggested that exercise is very important for Parkinson's disease. We~     are interested especially in dance as a form of exercise, because it combines physical~     movements with balance tasks, social engagement, and mental stimulation. Therefore, we think~     dance classes may be a very beneficial exercise for Parkinson's disease; the purpose of this~     study is to see if Argentinean Tango classes might improve motor and non-motor~     manifestations of Parkinson's disease.~   "
113294|NCT01573247|"~     This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine~     the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for~     further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML).~     The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.~   "
113295|NCT01573234|"~     Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best~     practice clinical care in subjects with cut injuries and abrasions with particular regard~     to: Wound healing (complete reepithelialization) and patient's pain.~      In the context of the study will be collected secondary outcomes related to type of lesion~     and its clinical evolution through the analysis of the items in the scale of the Pressure~     Sore Status Tool(PSST).~   "
113296|NCT01573221|"~     Evaluation of the sensitivity and specificity of PMSI to identify the burden of stroke in~     France,from 2500 cases~   "
113297|NCT01573208|"~     The goal of the study is to know if the reconstruction of the lower limb mechanical axis and~     the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient~     specific instruments.~   "
113298|NCT01573195|"~     The purpose of this study is to pilot the use of best practices alerts to enhance an~     antimicrobial stewardship program using the electronic medical record, EPIC.~   "
113299|NCT01573182|"~     The purpose of this study is to determine whether vaccination of stem cell donors with~     Zostavax can reduce the rate of Herpes Zoster reactivations in transplant recipients.~      The clinical hypotheses is: 1) that Zostavax given to stem cell donors will induce~     protective VZV specific T cell proliferation in allogeneic stem cell transplant recipients~     that can be transferred to recipients; 2) and that donor vaccination with Zostavax is safe~     for transplant recipients as measured by viral load measurement by polymerase chain reaction~     assay (PCR) at the time of stem cell donation.~   "
113300|NCT01573169|"~     Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.~     Intermittent pneumatic compression combined with elastic stockings have been shown to be~     superior to elastic stockings alone in reducing the rate of asymptomatic deep vein~     thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings~     alone are ineffective in preventing deep vein thrombosis in patients with ischemic or~     hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous~     thromboembolism in patients with ICH because the use of anticoagulants may cause an~     enlargement of the hematoma. In a multicenter, randomized trial, the investigators will~     assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in~     patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or~     standard therapy (graduated compression stockings and/or intermittent pneumatic compression~     and/or early mobilization) will be given subcutaneously for not less than 10 days beginning~     after 72 hours from stroke onset.~   "
113301|NCT01573156|"~     Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11,~     may offer an alternative, providing tumour destruction via a minimally invasive approach. In~     this investigation, the investigators plan to use the WST11 VTP procedure to treat a~     predetermined small renal tumour targets. Patients will be given a general anaesthetic, to~     ensure immobility, and prevent discomfort during treatment sessions. Treated patients will~     then undergo surgical resection of their tumours, and the accuracy and reliability of tissue~     death with VTP will be assessed histologically. The aim of this proof of concept study is to~     demonstrate whether this modality has potential for a clinical role in the treatment of~     oncological kidney disease, either as an alternative to surgery, or where surgery is not~     feasible.~   "
113305|NCT01573104|"~     The investigators have a new technique of looking at urine to see whether it contains~     protein fragments that are released by damaged kidneys. These fragments seem to be more~     accurate than the current blood tests that the investigators use to diagnose renal failure.~     This technique needs to be validated with a group of patients that have a relatively high~     incidence of renal failure, cardiopulmonary bypass.~      The investigators hypothesise that using novel markers of renal dysfunction will identify~     patients who go on to develop renal failure earlier, and in a higher number than the~     standard blood tests.~      The investigators aim to collect urine from patients before going onto bypass, and then at~     Day 1 and Day 2 after bypass. This urine will be analysed for protein fragments, as well as~     other new markers of renal dysfunction. The investigators will also take blood at baseline~     and for the first two days in Cardiac Intensive Care, and compare the accuracy of the new~     tests with the 'gold standard' that is creatinine.~   "
113306|NCT01573091|"~     The purpose of the study is to collect some parameters (clinical, electrical, radiographic,~     echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.~   "
113307|NCT01573078|"~     The purpose of this study is to determine whether emotional processing and somatic~     dissociation influence IBS-like symptoms in Crohn's Disease patients.~   "
113308|NCT01573065|"~     The purpose of this study was to determine whether a brief counseling intervention coupled~     with rapid HIV testing was feasible and effective at decreasing alcohol consumption and~     sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency~     Department.~   "
113309|NCT01573052|"~     A randomized, double-blind controlled trial comparing treatment outcomes between~     chloriazepide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent~     veteran subjects. The objective of this trial is to compare the safety and effectiveness of~     these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin~     over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence,~     withdrawal severity scores, adverse events including ataxia, sedation, cognitive function~     and alcohol craving.~   "
113310|NCT01573039|"~     CMV disease is a challenge to the success of renal transplantation. Recently, the~     investigators analyzed data from 792 renal transplant recipients performed at our hospital~     between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This~     population showed that the incidence of CMV disease is stable and occurs in approximately~     20-22% of all patients and invasive disease in approximately 5% every year. In seronegative~     patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir~     for 90 days is our routine and in the majority of transplant centers. In seropositive~     patients without associated risk factors (such as the use of AL) universal prophylaxis is~     not done. Rather, in this group, early diagnosis, by detection of antigenemia or viremia by~     quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In~     the investigators analysis the incidence of CMV disease in seropositive patients is around~     16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This~     leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion,~     etc. Besides these costs, the survival of the grafts in the long run is lower in patients~     with CMV disease than in those without CMV, particularly when associated with acute~     rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive~     treatment when it reaches substantial values, have increasingly been suggested. Patients in~     whom the detection of viremia in progressive values is detected would be treated as~     outpatients before the disease develops. To turn this hypothesis into reality, there is an~     urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.~   "
113311|NCT01573026|"~     The purpose of this research study is to document the use if the Keystone Dental Genesis~     Dental Implant System in standard clinical use and to provide 5 year survival data.~   "
113312|NCT01573013|"~     In a cross-sectional study allotted by the ethical committee of the ETH Zurich, we are~     investigating the extent of anemia, iron deficiency and lead intoxication in young children.~     For this purpose an assessment of body lead burden and iron status was conducted in a cohort~     of individuals residing in areas of presumed high lead exposure. Associations between lead~     burden and iron status will be investigated in the near future (current status of the~     study).~      In a follow-on intervention study, the effect of iron fortification with and without NaEDTA~     on blood lead levels in lead-exposed children will be evaluated; and the relative impact of~     these two strategies on child growth, motor and cognitive test performance will be compared.~      This study will investigate the potential use of iron fortification to not only combat~     anemia but also reduce body lead burden in lead-exposed populations; it specifically~     investigates whether iron fortification with NaFeEDTA could have additional beneficial~     effects to iron alone.~   "
113313|NCT01573000|"~     Subjects were randomized to receive either tositumomab (Anti-B1 Antibody) and iodine I 131~     tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to Arm B were~     allowed to cross over and receive I 131 tositumomab once their disease had progressed as~     long as they still fulfilled the protocol entry criteria (except for exclusion criterion 12,~     prior monoclonal antibody therapy) and were human anti-murine antibody (HAMA) negative.~     Study endpoint assessments of response were conducted by a Masked Independent Randomized~     Radiographic and Oncologic Review (MIRROR) panel and the Study Investigators' assessments of~     safety and survival. Subjects who completed at least two years of follow-up in Protocol~     BEX104515 (formerly Corixa Protocol RIT-II-002) were enrolled in long term follow-up~     Protocol BEX104526 (formerly Corixa Protocol CCBX001-051), an administrative protocol, for~     continued radiographic response evaluations and safety evaluations every 6 months for years~     3 through 5 post-treatment and annually for years 6 through 10 post-treatment. Subjects in~     BEX104526 were assessed for survival, disease status, subsequent therapy for NHL, and~     long-term safety, including the use of thyroid medication, development of hypothyroidism,~     human anti murine antibody (HAMA), myelodysplastic syndrome, acute myelogenous leukemia, and~     all other secondary malignancies. Additionally, subjects were followed for the development~     of any adverse event(s) deemed by the Principal Investigator as being possibly or probably~     related to a subject's previous treatment with Iodine I-131 tositumomab. Laboratory~     evaluations consisting of a thyroid stimulating hormone level and a complete blood cell~     count, with a differential and platelet count, were obtained annually through year 10~     post-treatment.~      Dosimetric Dose: Subjects received 450 mg of tositumomab IV followed by 5.0 mCi of Iodine~     I-131 and 35 mg of tositumomab. Following the dosimetric dose, whole body dosimetry was~     performed on each subject using a total body gamma camera. Whole body anterior and posterior~     whole body images were obtained at the following timepoints.~        1. Within one hour of infusion of the dosimetric dose and prior to urination~        2. 2-4 days after infusion of the dosimetric dose, following urination~        3. 6-7 days after infusion of the dosimetric dose, following urination Therapeutic Dose:~          The total body residence time, derived from total body gamma camera counts obtained at~          the 3 time points, was used to calculate the iodine-131 activity (mCi) to be~          administered to deliver the therapeutic total body irradiation dose of 65 or 75 cGy.~          The therapeutic step was administered 7-14 days after the dosimetric step and consisted~          of tositumomab 450 mg followed by an activity (mCi) of iodine-131 calculated to deliver~          75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg of~          tositumomab.~      For subjects with ≥150,000 platelets/mm3, the recommended dose was the activity of~     iodine-131 calculated to deliver 75 cGy of total body irradiation; for subjects with NCI~     Grade 1 thrombocytopenia (platelet counts ≥100,000 but <150,000 platelets/mm3), the~     recommended dose was the activity of iodine-131 calculated to deliver 65 cGy of total body~     irradiation.~   "
113316|NCT01572961|"~     Current stimulation induces microvascular dilation in human skin. The investigators aimed to~     study (1) whether the current vasodilation is amplified after two segmental current~     stimulation as compared to one stimulation; (2) whether this amplification relies on~     prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover~     trial is conducted in Angers, France.~   "
113317|NCT01572948|"~     The purpose of the study is to propose that roflumilast is associated with meaningful~     reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including~     confirmation of previously described results, and correlate these findings with improvement~     in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD.~     The investigators aim to demonstrate this regardless of concomitant medication use,~     including inhaled corticosteroids. Additionally, the investigators hope to provide a~     mechanistic pathway by which these effects occur.~   "
113318|NCT01572935|"~     Background: Recent evidence from several countries has emerged suggesting that the increase~     in the prevalence of childhood obesity has slowed down substantially, or even leveled off.~     Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and~     girls, respectively, were overweight or obese in Switzerland. In 2007, the prevalence of~     overweight was significantly lower, with 11.3% and 9.9% of school-aged boys and girls,~     respectively, being overweight or obese. Further trend analyses are necessary to confirm~     that the stabilizing trend observed reflects a long-term change in the rates of childhood~     overweight and obesity.~      Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national~     studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12~     year old children in Switzerland during this 5 respectively 10 year time period. Height and~     weight will be measured and used to calculate body mass index (BMI). BMI references form the~     Centers for Disease Control and Prevention will be used to determine the prevalence of~     underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥~     95th percentile). Waist and hip circumference will be measured. Moreover, skinfold~     thicknesses and bioelectrical impedance analysis will be performed to calculate body fat~     percentage.~   "
113319|NCT01572922|"~     Iron overload is a severe complication of multiple blood transfusions. As the body has no~     physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in~     organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to~     quantify excessive iron accumulation and to monitor response to iron chelation therapy.~     Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic~     iron concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2~     and R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown~     that their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g.~     Current R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads~     (HIC ~ 15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2*~     is so high that the MR signal decays before it can be measured accurately.~      Overall accrual: 235 (200 patients, 35 healthy volunteers)~      Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of~     people with large amounts of iron and compare the results with the same patient's liver bx.~     Estimated patient accrual is 200. It is estimated that 41 of these patients will have~     clinical indication for liver biopsy.~      Volunteer purpose: To test the UTE MRI to ensure it runs correctly before testing in~     patients, collect data of normal values of iron in the liver in people without iron overload~     using the UTE MRI and to compare the current MRI (GRE) with the UTE. The UTE MRI will give~     an accurate value of liver iron in patients with large iron deposits in the liver, therefore~     providing an accurate means to diagnose, monitor, and provide treatments for participants.~     This new technology will impact the care of many different populations with iron overload,~     such as patients with sickle cell disease and thalassemia. Estimated accrual for healthy~     volunteers is 35.~   "
113320|NCT01572909|"~     The purpose of this research study is to assess the effectiveness, safety and tolerability~     of an investigational drug, called Bendavia, on reducing the area of heart muscle affected~     by a myocardial infarction (heart attack) in participants who have undergone successful~     coronary intervention (heart treatment) and stenting.~      Participation in the study is due to last for approximately 7 months. It is planned that up~     to 300 participants will take part in the study from centers in the United States and around~     the world.~   "
113321|NCT01572896|"~     The purpose of this study is to demonstrate the effectiveness of the Taking Charge:~     Managing JIA Online Internet intervention, when compared with an attention (static~     education only websites) control group in improving pain and HRQL as well as other health~     outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and~     self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294~     adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to~     either the experimental or control groups.~   "
113322|NCT01572883|"~     The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab~     (patients treated for early breast cancer) is really safe for the heart even years after~     treatment and if the investigators should use these two treatments concomitantly without~     additional harm.~   "
113323|NCT01572870|"~     Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease~     in CF Patients.~      Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to~     ABPA or persistent Aspergillus infection.~      Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be~     assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1~     duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be~     assessed for RAST, skin prick test.~      Primary outcome measure is the difference in CHIT1 genotyping between the groups.~   "
113324|NCT01572857|"~     The measurement of 24-hour proteinuria allows an assessment of treatment response in~     patients with multiple myeloma. But it is difficult and restrictive to make.~      This study was therefore designed to investigate the correlation between the ratio of~     proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in~     assessing response to this treatment .~   "
113336|NCT01572701|"~     This is a single arm, open label study of up to 24 high risk prostate cancer patients~     scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single~     IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection.~     As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection~     (PLND) within two weeks of study drug dosing. Patients may receive a second injection of~     study drug within 24 hours of surgery to measure activity counts in tissue samples~     post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated~     for visible uptake and compared with histopathology.~   "
113337|NCT01572688|"~     The purpose of the study is to evaluate the safety and effectiveness of melphalan for~     injection for autologous stem cell transplant in multiple myeloma~   "
113325|NCT01572844|"~     Dermatomyositis is an inflammatory muscle disorder that is often associated with many skin~     findings. One of the skin findings seen in up to 50% of individuals with juvenile~     dermatomyositis, an early onset form of this condition, and up to 20-30% of adult~     dermatomyositis patients who have not responded to treatment, is calcinosis, or deposits of~     calcium within the skin and muscle tissue. In addition to being cosmetically unappealing,~     involvement of deeper tissues with calcinosis may lead to contractures, or shortening of~     muscles, which may have a significant impact on functioning and quality of life.~     Unfortunately, there is no known effective treatment of dermatomyositis associated~     calcinosis. However, recent reports have shown that a medication called sodium thiosulfate~     has been effective in treating individuals with calciphylaxis, a condition where calcium is~     deposited within blood vessels, and with tumoral calcinosis, a genetic form of~     calcification, when receiving this medication by vein. In addition, recent advances in laser~     technology have led to the development of methods that may allow topical medications to~     penetrate deeper layers of the skin. The investigators have designed a pilot study to~     evaluate the use of topical sodium thiosulfate solution in treating superficial calcinosis~     in individuals with juvenile and adult dermatomyositis. The investigators will use laser to~     assist in the delivery of this medication to areas of calcinosis.~   "
113326|NCT01572831|"~     Patients in the ICU whose infection is resolving will be randomized to standard duration of~     antibiotics compared to duration determined by a combination of a procalcitonin value and a~     simple evaluation of clinical status.~   "
113327|NCT01572818|"~     The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as~     evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron~     overload patients.~   "
113328|NCT01572805|"~     The purpose of this study is to assess the effect of melatonin on pain and amount of blood~     loss after cesarean delivery one hundred twenty women with singleton term pregnancy~     undergoing elective or emergency lower segment cesarean section under spinal anesthesia were~     included in this study. The patients were randomly allocated to one of three groups of 40~     each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of~     anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated~     Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after~     delivery of the neonate was infused . Time to first requirement of analgesic supplement,~     Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of~     the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain~     assessment. If the VRS exceeded four and the patient requested a supplement analgesic,~     diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For~     breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine~     25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for~     additional oxytocics and ,the volume of blood in the suction bottle was measured, blood~     soaked sponges. Hemoglobin values were determined both before surgery and 12 h following~     surgery~   "
113329|NCT01572792|"~     The purpose of this Phase III study is to evaluate the long-term safety and tolerability of~     two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium~     bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic~     Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and~     health-related quality of life assessments will also be evaluated. This extension study will~     include a 28 week treatment period, followed by a four week follow up visit. All patients~     will remain in the same treatment group as for the lead-in study and continue on one of the~     four treatment arms or placebo.~   "
113330|NCT01572779|"~     A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread~     across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks~     for the chronic group. The device records movement and muscle activity data relating to the~     lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or~     vibration and aims to prompt the subject to alter their posture or position in line with~     recommendations given by the treating practitioner. Four small sensors are adhered to the~     lower back and send data wirelessly to a data logger carried in the pocket by the subject~     (the size of a small mobile phone).~   "
113331|NCT01572766|"~     The study seeks to determine the impact of assessing risk for osteoporosis in women on~     patient and physician behaviors through a pharmacist directed osteoporosis screening~     program. Women will be offered a heel ultrasound to screen for their bone density and may or~     may not be asked questions about their risk for bone fracture. Pharmacists will counsel and~     educate all women on ways to prevent the onset of osteoporosis. Women will be telephoned~     three months after the screening and asked a series of 10 questions to follow up on~     decisions made by their physicians or changes made to their health behaviors related to bone~     health.~   "
113332|NCT01572753|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing~     conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.~   "
113333|NCT01572740|"~     This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and~     safety of liraglutide in combination with insulin therapy compared to insulin alone in~     Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial~     insulin therapy.~   "
113334|NCT01572727|"~     This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective~     and safe in treating patients with HER2- locally advanced or metastatic breast cancer.~   "
113335|NCT01572714|"~     The objective of this study is to conduct a randomized controlled trial to examine the~     effectiveness of a telehealth intervention that supports individuals in managing fatigue and~     increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The~     hypothesis is that a fatigue management plus physical activity intervention will~     significantly improve fatigue, quality of life, physical function, and community~     integration.~   "
113338|NCT01572675|"~     This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical~     practice in France as well as the use of celecoxib (Celebrex®).~   "
113388|NCT01572025|"~     -  To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to~          and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved)~          and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and~          IVF/ICSI treatment.~        -  To evaluate the feasibility of conducting a large multicentre trial~   "
113339|NCT01572662|"~     The goal of this clinical research study is to learn if giving busulfan and fludarabine~     before a stem cell transplant can help control the disease better than the standard method~     in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses~     of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of~     busulfan and fludarabine during the week before the stem cell transplant, rather than the~     standard method of giving 4 doses of busulfan and fludarabine only during the week before~     the stem cell transplant.~      The safety of this combination therapy will also be studied.~      Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells),~     which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.~      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the~     cancer cells to die.~   "
113340|NCT01572649|"~     Primary Objective:~      - To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as~     compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric~     population (10-17 years old) and adults as controls~      Secondary Objectives:~      - To evaluate in both paediatric and adult populations:~        -  the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single~          subcutaneous ascending doses~        -  the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide~          and glucagon plasma concentrations following a standardized breakfast~        -  safety and tolerability.~   "
113341|NCT01572636|"~     This is a standard of care treatment guideline for patients with the diagnosis of~     mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are being considered as~     candidates for first hematopoietic stem cell transplantation (HSCT) according to a~     University of Minnesota myeloablative HSCT protocol.~   "
113342|NCT01572623|"~     The purpose of this study is to evaluate the efficacy and safety of two different loading~     doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural~     ischemic brain damage in patients undergoing carotid angioplasty.~   "
113343|NCT01572610|"~     A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney~     disease (CKD) patients with type 2 diabetes mellitus.~   "
113344|NCT01572597|"~     Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and~     amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole,~     clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter~     pylori infection.~   "
113345|NCT01572584|"~     Background~        -  Assessment of the percentage of lung collapse is crucial in the therapeutic~          decision-making of pneumothorax.~        -  The methods normally used to this purpose are radiological. Computerized tomography~          scan (CT) is highly accurate because it allows the exact evaluation of the volume of~          the air layer. However, in clinical practice assessment of the volume of pneumothorax~          mainly relies on the measurement of the inter-pleural distance at conventional chest~          radiography (CXR). This latter method is inaccurate.~        -  Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax,~          with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.~        -  The scientific community is actually debating about the usefulness of lung ultrasound~          in the quantification of pneumothorax []. Lung ultrasound can assess the superficial~          extension of the pneumothorax, but cannot evaluate its volume.~      Aim~        -  Main purpose of the study is to compare measurement of the superficial extension of~          pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the~          air volume performed by CT in patients with pneumothorax.~        -  The main hypothesis of the study is that the cut-off between small (<11% of lung~          collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung~          ultrasound evaluation of the superficial extension of pneumothorax.~        -  Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in~          predicting the volume of pneumothorax assessed by CT.~        -  Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the~          prediction of volume of pneumothorax and percentage of lung collapse.~      Methods~        -  Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled~          and submitted to lung ultrasound within 20 min from the CT study.~        -  Different locations of the sonographic lung point on the chest wall (i.e. the point~          on the chest wall where the sonographic pattern of the normally aerated lung alternates~          with the pathologic sonographic pattern of pneumothorax) are compared with different~          volumes of pneumothorax measured by CT.~   "
113346|NCT01572571|"~     Background~        -  Symptomatic undifferentiated hypotension represents a negative prognostic factor and~          the strongest predictor of in-hospital mortality.~        -  Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening~          conditions.~      Aim~      - The aim of the study is to evaluate the feasibility and accuracy of a new bedside~     ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins,~     in emergency.~      Methods~        -  Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining~          of at least one of the neurologic, respiratory and cutaneous signs and symptoms of~          inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment~          of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.~        -  On the basis of physical examination and ultrasound results, the operator declares the~          diagnostic hypothesis without influencing the attending physician and the following~          diagnostic procedure (which includes ultrasound, when needed).~        -  The diagnostic hypothesis is compared with the final diagnosis, obtained after the~          hospital route and discussed by a panel of three blinded experts (one radiologist, one~          cardiologist and one emergency physician).~        -  The statistical agreement is calculated by the k of Cohen with p-value, confidence~          intervals and raw agreement (Ra).~   "
113347|NCT01572558|"~     This is a feasibility study that will be performed at the Astrid Lindgren Children´s~     Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients,~     randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The~     study will test an computerized randomization system, the availability of patients willing~     to participate in the trial and the trial protocol. The investigators will assess the~     characteristics of the patients who agree to participate in the study and those who do not.~     The investigators will explore short term outcome and design suitable long term outcome~     measures.~   "
113348|NCT01572545|"~     The primary aim of the study is the comparative effect of zolendronic acid versus denosumab~     on serum sclerostin levels in postmenopausal women with low bone mass.~      Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor~     activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen~     type I N-terminal peptide [PINP] and C-terminal cross-linking telopeptide of type I collagen~     [CTX]).~   "
113358|NCT01572415|"~     The primary objective is to identify compare SCOUT DS to random capillary glucose for~     identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.~   "
113359|NCT01572402|"~     Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides~     will be measured in patients with type 2 diabetes versus healthy subjects in a fasting~     status and in response to standard meals (at times 0', 30', 60', 120' and 180').~   "
116906|NCT01525810|"~     The primary purpose of this study is to determine whether the hepatitis C virus continues to~     remain unable to be detected in subjects who were previously treated with BMS-914143 and~     achieved sustained virologic response~   "
113349|NCT01572532|"~     The primary aim of this study is to determine the impact of community-based screening and~     treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19~     weeks) on preterm live birth in Sylhet district, Bangladesh.~      Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent~     score >4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the~     population rate of preterm live birth by at least 15%.~      The secondary aims of this study are:~        -  To determine the impact of community-based screening and treatment of abnormal vaginal~          flora and urinary tract infections on the:~             -  proportion of pregnancies with outcomes occurring prior to 37 weeks (late~               miscarriage, preterm still birth and preterm live birth); and~             -  proportion of babies with early onset neonatal sepsis.~        -  To determine the prevalence of abnormal vaginal flora and urinary tract infections,~          including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.~        -  To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for~          detecting bacterial vaginosis and urinary tract infections by community health workers~          in a rural, developing country setting.~   "
113350|NCT01572519|"~     The purpose of this study is to determine the safety, pharmacokinetics, and preliminary~     efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin~     lymphoma.~   "
113351|NCT01572506|"~     Background:~      - Anemia occurs commonly and is associated with poor outcomes in the elderly. In about a~     third of anemia cases in older people (over age 65), the cause of anemia is unexplained.~     Anemia in older adults may be caused by the bone marrow's inability to produce red blood~     cells fast enough to replace older red blood cells that have died. Researchers want to look~     at unexplained anemia by studying the life span of red blood cells in younger adults and~     older adults. To do so, a vitamin called Biotin will be used as a marker on the red blood~     cells.~      Objectives:~      - To investigate possible causes of unexplained anemia in older people.~      Eligibility:~        -  Individuals in the following groups:~        -  Men and women between 18 and 50 years of age who do not have anemia~        -  Men and women at least 70 years of age who do not have anemia.~        -  Men and women at least 70 years of age who have iron-deficiency anemia.~        -  Men and women at least 70 years of age who have anemia with no known cause.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an overnight stay for the first study visit. They will provide a~          blood sample to which Biotin will be added. The blood sample with Biotin will then be~          returned to the participant. Twenty-four hours later, another blood sample will be~          collected.~        -  Participants will have up to 14 additional study visits. At each visit, blood samples~          will be collected to measure the amount of Biotin remaining in the blood.~        -  Participants may also provide a separate blood sample for genetic testing. These tests~          may provide more information about genetic causes of unexplained anemia.~   "
113352|NCT01572493|"~     Background:~      - People with cancer can have a weak immune system as a result of the cancer itself, or from~     prior treatments. . Still, treatments that stimulate the immune system have been shown to be~     effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15)~     is a drug that is designed to boost the immune system. Researchers are interested in seeing~     if rhIL-15 can strengthen the immune system's response against cancer. The drug will be~     given through a vein without a break for 10 days (240 hours).~      Objectives:~        -  To see rhIL-15 given as a continuous infusion over 10 days can be used to treat~          advanced cancer~        -  Identify the side effects associated with this treatment.~      Eligibility:~      - Individuals at least 18 years of age with advanced cancer for which there are no effective~     treatments.~      Design:~        -  Participants screening procedures will include a physical exam and medical history,~          laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the~          protocol. --Appropriate participants with easily accessible tumor deposits may also be~          asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. .~        -  Eligible participants will be admitted to the hospital for the rhIL-15 treatment and~          will spend about 12 days in the hospital. .~        -  Participants will receive one 10 day infusion each cycle (about every 42 days) for as~          long as there are no serious side effects and the disease does not progress.~        -  Participants will continue treatment as long as imaging studies show that the tumor~          continues to shrink or for two additional cycles after it has disappeared from the~          x-rays to make that the cancer is completely gone.~        -  Participants who stop treatment for side effects or because their tumor did not shrink~          or stopped responding to the treatment will continue to have follow-up visits to~          monitor the outcome of the rhIL-15 treatment until there is evidence their cancer has~          progress or they begin another treatment.~   "
113353|NCT01572480|"~     Background:~        -  Multiple myeloma is a blood cancer that affects the plasma cells. These cells help~          produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related~          condition that may develop into multiple myeloma. The current standard of care for SMM~          is close follow-up without treatment until multiple myeloma develops. However,~          researchers are studying possible treatments for SMM itself. One possible treatment~          involves a combination of cancer treatment drugs.~        -  Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells.~          Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two~          drugs are an approved treatment for multiple myeloma that has not responded to at least~          one other treatment. Carfilzomib is an experimental drug that has been effective in~          treating multiple myeloma. Researchers want to combine these three drugs to see if they~          are a safe and effective treatment for SMM.~      Objectives:~      - To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment~     for smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have SMM that is likely to progress to multiple~     myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will~          also be collected.~        -  Participants will have eight 28-day cycles of treatment with the three study drugs. The~          drugs will be given as tablets or as infusions. Treatment will be monitored with~          frequent blood tests and study visits.~        -  After the first four cycles, participants who are eligible for a stem cell transplant~          will have their stem cells collected and stored for future use.~        -  At the end of eight cycles, participants whose disease has not progressed will have up~          to 12 more cycles of treatment with lenalidomide tablets alone.~   "
113354|NCT01572467|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify biomarkers related to cancer.~      PURPOSE: This research trial is studying genes in tumor samples from younger patients with~     ovarian or testicular sex cord stromal tumors.~   "
113355|NCT01572454|"~     We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease~     the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in~     patients undergoing off-pump coronary artery bypass graft, and trying compare these effects~     with those of remifentanil infusion.~   "
113356|NCT01572441|"~     The purpose of this study is to observe parent-adolescent interactions and to examine the~     parenting behaviors and adolescent emotional and physiological responses that are associated~     with youth's substance use.~   "
113357|NCT01572428|"~     This is a study to determine if using Narrow-Band Imaging of the colon, rather than the~     usual white light on the colon, will improve the detection of a type of polyp called~     serrated. The polyps are called serrated because of their appearance under the microscope~     after they have been removed. They tend to be located up high in the colon, far away from~     the rectum. They have been definitely shown to be a type of precancerous polyp and it is~     possible that using Narrow-Band Imaging will make it easier to see them, as they can be~     quite difficult to see with standard white light.~   "
113360|NCT01572389|"~     This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient~     Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at~     6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242~     largely rural Veterans with uncontrolled diabetes and clinically-significant depressive~     symptoms. Both groups will receive screening, education, and notification of clinical~     findings along with follow-up in usual primary care. HOPE participants will also receive~     behavioral coaching telephone sessions over a six month period. Patients in the control~     group will be screened, and providers will be notified of high risk patients' status and~     need for intervention. Both groups will receive only usual primary care during the~     subsequent 6 month maintenance period. Study measurements using self-report questionnaires~     will also be collected at baseline, 6 and 12 months follow-up. The investigators will also~     conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in~     measurements from baseline will be compared between groups. This intervention will reach~     Veterans in rural setting where community-based primary care is needed, especially care that~     blends treatment strategies for physical and emotional health.~   "
113361|NCT01572376|"~     The aim of the study is to determine the safety and feasibility of an autologous mononuclear~     stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the~     efficacy of the treatment.~   "
113362|NCT01572363|"~     In patients with one anatomical or functional ventricular chamber, which encompasses a~     spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in~     view of an ultimate Fontan operation has become the procedure of choice. Especially in the~     earlier era, perioperative mortality was the leading cause of death. However, many patients~     have a long and high-quality life, continuously improved by a better understanding of Fontan~     hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of~     eventual failure of the Fontan circulation remains a major concern. More specifically,~     evaluation of the pulmonary circulation becomes particularly important as the failing Fontan~     circulation has become a common indication for cardiac transplantation. Although essential,~     especially in the preoperative setting, a comprehensive evaluation of the pulmonary~     circulation remains difficult in this patient population~      Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the~     development of pulmonary vascular lesions after the Fontan operation and that - together the~     absence of a subpulmonary ventricle for pressure generation - this increasing afterload will~     result in systemic ventricular underfilling and will eventually lead to a failing Fontan~     circulation.~   "
113363|NCT01572350|"~     This clinical trial is designed to investigate differences in terms of efficacy (mean change~     in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3~     therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser~     alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.~   "
113364|NCT01572337|"~     A large multicentre, randomized, controlled trial to demonstrate that non invasive~     ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive~     care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to~     the best available treatment usually performed in the non-ICU wards.~   "
113365|NCT01572324|"~     This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic~     arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable~     Biliary tract carcinomas, and to explore a better first-line treatment regimen for these~     patients.~   "
113366|NCT01572311|"~     The investigators proposed research will establish whether combining aerobic exercise with~     cognitive challenges is feasible and effective in community dwelling older adults with early~     signs of cognitive impairment.~   "
113367|NCT01572298|"~     When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of~     bone may make it impossible to place a dental implant. Guided bone regeneration procedures~     are used to re-establish a bone dimension sufficient to place a dental implant. The primary~     objective of the study is to determine whether there is any difference in the gain of~     horizontal alveolar ridge width following guided bone regeneration surgery using a combined~     autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous~     bone has historically been considered the gold standard for alveolar ridge grafting;~     however, other materials including allografts and xenografts have also been used with~     excellent results. This study evaluates the potential benefits, or lack thereof, for using a~     combined autogenous/allograft approach versus an allograft alone. The investigators will~     clinically evaluate the efficacy of this technique and determine the difference in bone~     formation between groups following healing at 5 months by observing bone growth relative to~     heads of the tenting screws placed horizontally in the locations of greatest defect in the~     alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement.~     The null hypothesis is that there will be no difference in the amount of horizontal ridge~     width gain at 5 months post-grafting between the two different grafting materials (allograft~     alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is~     that histologically, the combination graft (MinerOss®/particulate autograft) will have a~     similar percentage of vital bone present at 5 months compared to the allograft-alone group~     (MinerOss®).~   "
113368|NCT01572285|"~     The purpose of this study is to determine whether transforaminal dexamethasone injections~     are effective in the treatment of chronic Hemiplegic Shoulder Pain.~   "
113369|NCT01572272|"~     Primary:~      The purpose of this study is to assess the clinical implications of continuous distal CO2~     monitoring when used for clinical decisions~      Sub Study:~      • Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison~     to the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying~     material).~      Description of Study Design:~      Patients will be randomized at the baseline evaluation visit into one of the following~     groups:~        -  Masked group: Data derived from the Capnostream20p will be recorded; however the~          medical staff will be masked from it and hence will not use it.~        -  Open group: Data derived from the Capnostream20p and displayed to the medical team. It~          will allow the treating physician and the nursing team to review the real time data and~          make clinical decisions based upon it if felt necessary.~   "
116907|NCT01525797|"~     The purpose of this study is to see what a lab test will show and if there is a way to~     predict which patients will be more likely to have rejection after receiving a liver~     transplant.~   "
113370|NCT01572259|"~     Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality~     in insulin resistant states. The typical dyslipidemia that is associated with insulin~     resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL)~     with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to~     play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48~     overproduction appeared as a newly recognized component of insulin resistance. There is only~     a limited amount of information in the literature regarding the factors and the mechanisms~     modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance~   "
113371|NCT01572246|"~     This observational protocol will evaluate the effects of monopolar electrocautery (ME) on~     implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause~     electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge~     (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will~     be used to prevent patients from receiving inadvertent shocks. This requires the presence of~     someone trained in ICD programming, but a trained person is not always readily available.~      In this study the investigators will reprogram ICDs prior to surgery according to current~     practice, but will also record what would have happened had the ICD reprogramming not~     occurred (detection on but therapy off). In addition, the investigators will evaluate~     the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of~     EMI. The investigators hypothesize that directing the current return path away from the ICD~     will result in lower EMI rates than previously described.~   "
113372|NCT01572233|"~     This 4-year project will be guided by a biobehavioral model for the study of exercise~     interventions in two phases with the purposes to :~        1. explore the patients' physical activity preferences and develop doable activity lists~          during treatment period~        2. examine the changes of health-related physical fitness component over interferon~          treatment~        3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test~          its effects on decreasing fatigue, physical and psychological distress, and improving~          their health-related physical fitness and quality of life in patients with chronic~          hepatitis C receiving Interferon with Ribavirin Combination Therapy~        4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the~          sustained virological response (SVR) in 24 weeks after the end of treatment, and the~          time-consuming for education program during intervention.~   "
113373|NCT01572220|"~     The current study is designed to have broad generalizability and inform a potential shift~     toward greater utilization of stress echocardiography with UCA. This will be accomplished by~     comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients~     presenting with atraumatic chest pain. This study seeks to demonstrate: clinical~     comparability of the 2 modalities (based on non-diagnostic test rates), improved care~     efficiency (based on length of stay), lower costs, improved provider satisfaction, and a~     presumed improved safety profile through the elimination of radiation exposure.~      Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography~     will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among~     patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.~   "
113374|NCT01572207|"~     The purpose of this research study is to evaluate whether tailored print material can~     promote physical activity and exercise, and subsequently improve quality of life and fitness~     levels among people with multiple sclerosis (MS). Research suggests that routine physical~     activity is beneficial in people with mild to moderate MS. However, people with MS may face~     many barriers for engaging in regular physical activity. Prescribing a home exercise program~     and receiving tailored motivational print material may help people engage in physical~     activity. Thus, the investigators hope to figure out whether tailored print material can be~     used as strategy to promote physical activity and improve physical function in people with~     MS.~   "
113375|NCT01572194|"~     Chronic renal failure is a serious complication of lung transplantation especially in~     patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has~     already exposed to kidney damage. Post-lung transplantation, these patients are subjected to~     renal toxicity anticalcineurins they receive large doses.~      The measurement of renal function of patients by formula to estimate GFR in routine use is~     unreliable and other markers seem indispensable.~      The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal~     peptide N), whose urinary levels was correlated to the intensity of fibrosis in different~     types of kidney disease.~   "
113376|NCT01572181|"~     The purpose of this study is to assess transplant-related mortality (TRM) at one year after~     allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a reduced~     toxicity myeloablative conditioning regimen in young patients (children and adolescents)~     with hematologic malignancies.~   "
113377|NCT01572168|"~     Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy~     and/or radiation. Recently, methods to measure fatigue have improved - however, no~     non-medication interventions have been studied. Ameliorating fatigue may result in an~     improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure~     and has been used for many indications in pediatric patients. Adult studies have suggested~     improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose~     using acupuncture for the treatment in cancer-related fatigue in children and adolescents~     with central nervous system tumors.~   "
113378|NCT01572155|"~     Hypothesis:~      Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and~     represents a new therapeutic approach to shorten postoperative ileus.~      Aims:~      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect~     of peroperative electrical stimulation of the vagus nerve. To this end, the following aims~     are formulated:~        1. to optimize the technique of intra-operative electrical vagus nerve stimulation~        2. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the~          inflammatory response to abdominal surgery~        3. to evaluate whether electrical stimulation of the vagus nerve leads to clinical~          improvement (collect pilot data)~   "
113389|NCT01572012|"~     This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of~     ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously,~     intramuscularly, and orally in normal healthy volunteers.~   "
113379|NCT01572142|"~     The overarching goal of this prospective cohort study is to test the hypotheses that greater~     severity of hyposmia is associated with increased risk of cognitive decline in PD and that~     worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the~     goals of this project, patients with PD without dementia or at-risk of dementia or with~     dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years.~     AChE [11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be~     performed both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will~     also be performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid~     PET will be performed at study entry or at 2 years (± 6 months). Annual olfactory testing~     will be performed to better understand dynamic changes underlying the clinical and PET~     outcome measures.~   "
113380|NCT01572129|"~     Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with~     aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous~     coronary intervention.~      The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in~     patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous~     coronary intervention.~   "
113381|NCT01572116|"~     The aim of this study was to compare the effects of Lidocaine/epinephrine with and without~     Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in~     teeth with irreversible pulpitis.~   "
113382|NCT01572103|"~     Background: In patients with chronic HCV-related liver damage, coffee is associated with a~     reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This~     prospective trial is aimed at assessing the mechanisms underlying the protective effect of~     coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with~     HCV-related hepatitis will be recruited and randomized into two groups: the first will~     consume 4 coffee cups/day/1 month, while the second will remain coffee abstinent. At day~     30, the two groups will be switched over and exposed to coffee or not for a second month.~     Before entering the study (time 0), during coffee exposure and during abstinence we will~     evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine~     (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.~   "
113383|NCT01572090|"~     Patients with overweight or obesity are in need to loose weight and represent a particularly~     challenging medical condition. Undoubtedly, any intervention achieving a negative energy~     balance over an extended time period will result in weight loss. Although several treatment~     modalities are available, currently the most extended approaches are lifestyle changes,~     pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the~     main therapeutic strategies involve either conventional treatment or bariatric surgery.~     Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per~     week. The main modifiable factors affecting energy balance are dietary energy intake and~     energy expended through physical activity. In spite of the difficulty in achieving relevant~     and sustained weight loss via the conventional approach, some patients are successful in~     reducing weight and obesity-associated complications. Bariatric surgery has proved to be the~     most effective long-term treatment for weight loss and comorbidity improvement. While some~     of the surgery-induced benefits are directly dependent on adipose tissue reduction, others~     are due to specific gastrointestinal changes that take place early on and before any~     significant effects on body weight are observed. The present study contemplates the~     determination and comparison of the anthropometric and metabolic changes produced by the~     conventional and surgery-induced treatment modalities. Particular emphasis will be placed on~     the potential differential effects between conventional and surgical weight loss on body~     composition changes, circulating adipokines and gastrointestinal hormones together with~     their subsequent impact on cardiometabolic risk factors.~   "
113384|NCT01572077|"~     The purpose of this study is to evaluate patterns of metabolic activity in the heart of~     patients with pulmonary arterial hypertension(PAH). Patients with PAH are at risk of~     developing weakness or failure of the right side of the heart.It is possible that there is a~     relationship between the development of heart failure and the way the heart uses energy~     sources, such as sugar. This study is designed to evaluate the way the heart uses sugar~     uptake in patients with PAH using positron emission tomography(PET imaging)~   "
113385|NCT01572064|"~     The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging~     (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators~     can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic~     venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring~     and portal hypertension.~   "
113386|NCT01572051|"~     Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of~     patients. Patients can become disabled early in life by OA. The Osteoarthritis Research~     Society International (OARSI) is concerned to publish guidelines with the respective levels~     of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is~     believed that an education program has a positive impact on quality of life of patients with~     OA. Changing the habits of those patients is imperative for clinical improvement.~      The investigators propose the creation of an educational program consisting of various~     health professionals so that we can educate the patients about OA disease, and their role in~     treatment. This program will be administered in a single day and reviewed/reinforced after~     an interval of time. Half the patients will be monitored monthly by phone when questions~     specific to each health area will be made to participants. This way we will evaluate the~     strength of the telephone follow-up. The investigators are going to create educational~     printed an audiovisual materials for patients, so the patients can access the information~     given in the theoretical course at home. Calculation of cost-effectiveness and presentation~     of data to the authorities.~   "
113387|NCT01572038|"~     This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and~     tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane~     (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with~     metastatic or locally recurrent HER2-positive breast cancer. Participants will receive~     pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3~     weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease~     progression, or death, whichever occurs first.~   "
113394|NCT01571947|"~     There is increasing evidence suggests that elevated levels of postprandial triacylglycerol~     (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A~     prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a~     variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and~     oxidative stress. However, current evidence on the acute effects of type of fats on~     postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as~     well as satiation are limited and inconsistent, in particular in metabolic syndrome~     population in Asian. Hence, this study aimed to investigate the postprandial effects of high~     fat meals enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic~     sunflower oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic~     syndrome.~   "
113395|NCT01571934|"~     Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly.~     The disease is classified based on how much factor VIII is in the blood. People with mild or~     moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with~     trauma or surgery. At the time of surgery, they need to receive factor VIII replacement by~     infusion into the vein so that blood can clot normally and abnormal bleeding can be avoided.~     A complication of hemophilia A is the development of an antibody that binds factor VIII and~     makes the factor VIII infused for treatment not work properly. This antibody is called an~     inhibitor. In mild and moderate hemophilia A, inhibitors are not common, but have been~     reported to occur after intensive factor VIII infusions, as may occur at the time of~     surgery. This study is designed to observe people with mild and moderate hemophilia A who~     are having surgery. Information on the surgery, treatments given, bleeding, and infection~     will be gathered. Also, blood will be drawn to determine how the immune system is reacting~     to the factor VIII. No specific treatments will be given as part of this study. We will use~     the information to determine what influences inhibitor development. A better understanding~     of inhibitor development will help medical providers do things to avoid inhibitor~     development in this population or researchers to design new treatments.~   "
113396|NCT01571921|"~     Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written~     informed consent to participate in the trial will be recruited to compare the rate and~     extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation~     with TRF.~   "
113397|NCT01571908|"~     Magnesium accelerates the reaction of rocuronium, a neuromuscular blocker used for muscle~     relaxation to ease the intubation during anaesthesia.~      Succinylcholine is a very fast reacting neuromuscular blocker. It is often used in emergency~     procedures, when rapid intubation is necessary.~      We want to now if a perfusion of magnesium before anaesthesia accelerates to such an extent~     the reaction of rocuronium that intubation conditions are comparable or even better than~     with succinylcholine alone (prior perfusion of saline=placebo)~   "
113398|NCT01571895|"~     The study will be a phase 2, multicentre, single arm, pilot study. It has been designed to~     determine if DF2156A has sufficient activity to warrant its further development.~      A total of twelve (12) BP patients will be involved, who will be administered DF2156A orally~     at the dose of 150 mg twice a day for a maximum of 14 days.~      Recruitment will be competitive among the study sites, until the planned number of patients~     is enrolled. Competitive recruitment has been chosen to increase the speed of recruitment~     and to account for any unexpected occurrence at a site that negatively impact enrolment~     rate.~      The single arm design has been chosen as an appropriate tool for this pilot phase 2 study,~     considering that BP is a rare disease where a placebo control is not acceptable. Moreover,~     as there is no spontaneous acute recovery from the active blistering condition, any~     improvement in patient outcome can be attributed to a positive effect of the Investigational~     Product.~      Each patient will be involved in the study for a screening period, for 14 days of treatment,~     for all required measurements up to hospital discharge (planned on day 8+1 of treatment) and~     for one assessment occasion on day 15+1, either during hospital stay or after hospital~     discharge (out-patient visit). An optional post-treatment visit might be scheduled at day~     30+3.~      The objective of this clinical trial is to evaluate whether DF2156A has a potential in~     improving the clinical outcome in patients with active blistering BP to warrant its further~     development. The safety of DF2156A in the specific clinical setting will be also evaluated.~   "
113399|NCT01571882|"~     The objective of this study is to investigate the effect of consumption of a low-fat, no~     added sugar, dairy fermented product enriched with plant sterols and policosanols at two~     doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of~     product consumption versus active control product.~   "
113400|NCT01571869|"~     The objective of this study is to compare efficacy of a plant sterol enriched yogurt given~     at different moments of the day in lowering blood cholesterol of hypercholesterolemic.~   "
113401|NCT01571856|"~     The purpose of this study is to determine the effect of zinc in acute watery diarrhea in~     children. The investigators will evaluate the effect of product versus placebo.~   "
113402|NCT01571843|"~     The purpose of the study is to determine the effect of forearm exercise on forearm bone~     density in post-menopausal women with or without primary hyperparathyroidism.~      The investigators hypothesize that forearm exercise will increase forearm bone density in~     patients with primary hyperparathyroidism more so than in patients without primary~     hyperparathyroidism.~   "
113410|NCT01571739|"~     Background:~      - Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB~     bacteria but have not become sick are said to have latent TB. Many people with latent TB~     will not get sick from it, but some people will develop active TB and become sick. Much is~     known about how to treat and diagnose active TB, but little is known about the best way to~     treat latent TB. Researchers also want to know more about the risk that latent TB will~     develop into active TB, and whether it is possible to test for this risk.~      Objectives:~      - To test possible methods of determining a person s risk for developing active TB.~      Eligibility:~      - Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to~     someone with active TB in the past 9 months, or (3) have not been exposed to TB.~      Design:~        -  Participants will be separated into groups based on their exposure to TB.~        -  Healthy participants who were not exposed to TB will answer questions about their~          medical history. They will also provide blood and urine samples.~        -  Participants who have active TB will have a physical exam and medical history. They~          will provide blood, urine, and sputum samples, and will have a chest x-ray. They will~          be treated with the standard of care for active TB. Some participants with active TB~          may have additional tests as part of this study.~        -  Participants who were exposed to TB and have latent TB will have a physical exam and~          medical history. They will provide blood, urine, and sputum samples, and will have a~          chest x-ray. They will be asked to return for five more clinic visits over the next 12~          months to repeat these tests. They may also have additional chest imaging studies~          depending on the study needs.~        -  Some of the exposed participants may have been exposed to drug-resistant TB. These~          participants will receive the drug isoniazid to take on a regular schedule to help~          prevent the latent TB from becoming active TB.~   "
113403|NCT01571830|"~     -  Hypothesis 1: Food allergies are associated with poor growth which can be corrected~          with nutrition intervention.~             -  More than 10% of children with multiple food allergies will have a weight-for-age~               z-score less than - 2 at diagnosis. The z-score is a measure of the distance from~               the mean value, or 50th percentile on the growth chart. A z-score of less than - 2~               indicates that the child is underweight.~             -  Growth parameters of children with multiple food allergies will improve after~               intervention by a team that includes a dietitian and an allergist.~        -  Hypothesis 2: Food allergies are associated with low micronutrient intake which can be~          corrected with nutrition intervention.~           o More than 30% of children with multiple food allergies will consume less than 67% of~          the Dietary Reference Intake for at least one macronutrient or micronutrient at~          diagnosis.~        -  Macronutrient and micronutrient intake will increase after intervention by a team that~          includes a dietitian and an allergist.~      • Hypothesis 3: Food allergies are related to behavioral feeding problems which can be~     corrected with nutrition intervention.~        -  At least 25% of children with multiple food allergies will have behavioral feeding~          problems at diagnosis.~        -  Prevalence of behavioral feeding problems will decrease after nutrition intervention.~   "
113404|NCT01571817|"~     The overall objective of this pilot project is to evaluate the safety and efficacy of the~     gastric submucosal space as a novel site for clinical islet transplantation. The site has~     several physiologic attributes that may improve the outcomes of islet transplantation~     compared with the conventional intraportal transplant site.~   "
113405|NCT01571804|"~     Preoperative administration of pregabalin would reduce the end tidal concentration of~     sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the~     quality of postoperative analgesia.~   "
113406|NCT01571791|"~     Rheumatic heart valve diseases are prevalent among the young people in Egypt secondary to~     the socioeconomic conditions. The goal of anesthetic management of these patients is~     maintenance of sinus rhythm, systemic blood pressure, preload, coronary perfusion, and~     cardiac output. Many women still prefer general anesthesia rather than regional techniques~     at the author's country.~      The pharmacological modifications of the sympathetic response to tracheal intubation and~     surgical stimulation using opioids have adverse effects on the neonatal outcome after~     cesarean delivery. The authors have demonstrated in their previous studies the safety of~     both perioperative infusion of both of ketorolac and lidocaine in the attenuation of the~     hemodynamic and hormonal responses of tracheal intubation and surgery during cesarean~     delivery with favorable neonatal outcome and without added risk of perioperative bleeding.~     Therefore, the authors reported successful anesthetic management of a parturient with~     infective endocarditis on top of rheumatic mitral valve disease with use of~     paracetamol-lidocaine-ketorolac-propofol anesthesia.~      The investigators hypothesize that the perioperative use of ketorolac-lidocaine would reduce~     the maternal hemodynamic responses to intubation and surgery without any harmful effects on~     mother or baby during uncomplicated cesarean delivery in the parturients with valvular hear~     diseases.~      The investigators are aiming to compare the effects of ketorolac-lidocaine and fentanyl on~     surgical stress responses, intraoperative fentanyl and vasoactive drugs consumption and~     neonatal outcome during cesarean delivery in the parturients with valvular hear diseases.~   "
113407|NCT01571778|"~     The importance of healthcare worker hand hygiene in decreasing bacterial transmission~     between patients is well documented. Healthcare workers may don non-sterile gloves in~     routine care of patients, particularly for those patients known or suspected to harbor~     epidemiologically important microorganisms. Governing bodies currently recommend performing~     hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene~     post glove removal is well shown, however few studies exist to show utility of hand hygiene~     prior to donning gloves. In fact, data suggests that glove use is an impediment to hand~     hygiene and may reduce compliance with hand washing. In light of this and the fact that no~     evidence exists that washing hands BEFORE glove use is important, the aim of the study is to~     asses the utility of routine hand hygiene prior to donning non-sterile gloves before a~     patient contact.~   "
113408|NCT01571765|"~     The investigators will assess whether in Bushenyi District in southwestern Uganda, a two~     year intervention providing comprehensive MNCH programming will:~        -  Reduce morbidity and mortality for children under five years old and;~        -  Improve access to maternal health services Compared to a control community without MNCH~          intervention?~      Hypothesis:~      Comprehensive maternal, newborn and child health programming in Bushenyi Distrcit can have a~     positive impact on morbidity and mortality for children under five years and will improve~     access for women to maternal health services which may lead, in the longer term, to~     decreased maternal mortality.~   "
113409|NCT01571752|"~     Background:~      - Researchers have been studying patterns of mood and drug use in specific neighborhoods.~     This study will look at environmental factors that may affect drug use, addiction, and~     treatment seeking in Baltimore neighborhoods. The results could inform prevention efforts,~     enhance treatment interventions, and improve substance use outcomes.~      Objectives:~      - To better understand why some people start to use drugs, why some people who use drugs~     become addicted, and why some people who become addicted enter treatment.~      Eligibility:~      - Individuals at least 18 years of age who are living in the neighborhoods participating in~     the study.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will be~          separated into one of four groups: (1) people who do not use drugs, (2) people who have~          used drugs in the past, (3) people who are using drugs and want treatment, and (4)~          people who are using drugs and do not want treatment.~        -  This study will include two outpatient visits about 12 months apart. Each visit will~          last about 5 hours. Each study visit may be done in 1 day or in 2 days.~        -  At each study visit, participants will provide blood, breath, urine, and saliva~          samples. They will also have a heart function test and body measurements. They will~          complete questionnaires about personal and family history.~        -  There will be monthly follow-up phone calls between the two visits.~   "
113439|NCT01571362|"~     The primary objective of the study is to determine the analgesic efficacy and safety of~     ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to~     severe chronic low back pain.~   "
113411|NCT01571726|"~     Background:~      - Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells,~     which help produce antibodies and fight infection. MM is nearly always preceded by a~     pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering~     multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or~     SMM will develop MM. Also, the disease changes in those early states are not well~     understood. Researchers want to look at imaging studies of people with MGUS, SMM, and MM.~     They will study whether the growth of blood vessels can be used to predict disease~     progression.~      Objectives:~      - To use imaging studies to evaluate disease progression in multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and provide bone marrow samples.~        -  Participants will have positron emission tomography (PET) scans with the new contrast~          agent [18]F-Fluciclatide. The contrast agent is intended to show patterns of increased~          vessel growth in the bone marrow.~        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be~          done according to standard procedures.~        -  Researchers will compare these scans with blood tests and other clinical information to~          study disease progression of MGUS, SMM, and MM....~   "
113412|NCT01571713|"~     The study seeks to analyze the patient reported effects of pulmonary hypertension~     medications and compare these with the side effects described on the package inserts. Side~     effects for these PH medications have been described in the adult population, but have never~     been described in the pediatric population. This information can better improve patient care~     and be used to characterize the side effects resultant from these medications.~   "
113413|NCT01571700|"~     The purpose of the study is to determine whether patients with pulmonary hypertension (PH)~     have dysynchrony, and if so whether it is electrical or mechanical. Once this has been~     determined, during a catheterization the investigators will test if pacing the heart~     improves blood circulation.~   "
113414|NCT01571687|"~     Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high~     altitude illnesses. Recently, there is rising interest on coagulation activation during~     trekking and mountaineering in higher regions and on development of oxidative stress due to~     hypoxia. 30 volunteers have been examined during an high altitude research expedition to the~     7134m high mount Pik Lenin in Kyrgyzstan to investigate mechanisms of coagulation activation~     and effects of antioxidant supplements on oxidative stress.~   "
113415|NCT01571674|"~     The purpose of this study is to determine the validity of previously identified prognostic~     variables that may identify patients with shoulder pain that are likely to benefit from~     cervicothoracic spine manipulation.~   "
113416|NCT01571661|"~     This is a double blind, randomised, placebo controlled, single dose escalation,~     first-time-in-human, 5-way crossover study to assess the safety, tolerability,~     pharmacokinetic and pharmacodynamic parameters of ascending doses of GSK189075A in healthy~     subjects (Part A). Single doses will be given to 10 healthy subjects. The planned doses are~     20mg, 50mg, 150mg, 500mg, and 1000mg. Each subject will receive 4 of the 5 active doses and~     a placebo separated by a washout of 5-10 days. A second cohort of 6 subjects with type 2~     diabetes mellitus will receive 2 active doses and a placebo along with oral glucose in a~     three-way, randomised, placebo controlled, crossover design to assess glucose lowering~     following GSK189075A administration (Part B). Blood samples will be taken throughout the~     study day for pharmacokinetic analysis of prodrug and metabolites. Safety will be assessed~     by measurement of blood glucose, blood pressure, heart rate, ECGs, laboratory safety~     screens, and collection of adverse events.~   "
113417|NCT01571648|"~     The purpose of this study is to evaluate the tolerability of oral azacitidine in the~     treatment of patients with Myelodysplastic Syndromes (MDS).~   "
113418|NCT01571635|"~     Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in~     adults with Beta (β)-Thalassemia~   "
113419|NCT01571622|"~     The aim of the present study is to examine the therapeutic effect of whey protein~     concentrate (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be~     administered before breakfast and its effects on posprandial glucose, insulin, c-peptide,~     intact and total GIP and GLP-1, and DPP-4 plasma levels will be assessed.~   "
113420|NCT01571609|"~     The purpose of the present study is to conduct a thorough and relevant physiology study of~     carriers and non-carriers of the gene variant X in order to determine the effect of the~     genetic variant on various metabolic parameters.~   "
113421|NCT01571596|"~     The primary purpose of this study is to assess the safety and efficacy of repeated~     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia~     (XLH).~   "
113422|NCT01571583|"~     The purpose of this study is to evaluate the effectiveness of telaprevir in combination with~     Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C~     virus (HCV) genotype 1.~   "
113423|NCT01571570|"~     The purpose of this study is to evaluate the relative bioavailability and the short-term~     safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg,~     given as different formulations in healthy adult participants. In addition, this study is to~     assess for the acceptability of the taste of both liquid formulations.~   "
113424|NCT01571557|"~     This study will evaluate the relationship between time since onset of macular oedema~     symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and~     diagnostic procedures provided are at the discretion of the participating physicians~     according to their clinical judgment and local standard of medical care.~   "
113425|NCT01571544|"~     Unintentional hypothermia of a patient is a common adverse effect during surgical~     procedures. The aim of this prospective, randomised, controlled study is to determine~     whether the use of thermal suit could prevent surgical patient from experiencing thermal~     loss than conventional measures.~      Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between~     the groups is clinically relevant.~   "
113440|NCT01571349|"~     The investigators are trying to investigate the coagulation status of idiopathic (immune)~     thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von~     Willebrand factor level, thromboelastography.~   "
113441|NCT01571336|"~     This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during~     an interval of two years after Alacare®-PDT.~   "
113426|NCT01571531|"~     Today there is accumulating evidence from animal experiments that regeneration can be~     induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic~     approaches to induce some regeneration will be included in the treatment of patients with~     SCI. The aim of this proposal is to provide the required clinical basis for the~     implementation of novel interventional therapies. The establishment of combined clinical,~     functional and neurophysiological measures for a qualitative and quantitative assessment of~     spinal cord function in patients with SCI at different stages during rehabilitation~     represents a basic requirement to monitor any significant effect of a new treatment.~     Therefore, several European Paraplegic Centres involved in the rehabilitation of acute~     traumatic SCI patients build up a close collaboration for standardised assessment. The aim~     is to get knowledge about the natural recovery after spinal cord lesion in a larger~     population of patients in the sense of a historical control group and to bring new~     standardised assessment tools to the clinical setting.~   "
113427|NCT01571518|"~     After resection of lymph node positive breast cancer, the injection duration and timing of~     Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC~     (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.~   "
113428|NCT01571505|"~     Oral polio and rotavirus vaccines are significantly less effective in children living in the~     developing world. Tropical enteropathy, which is associated with intestinal inflammation,~     decreased absorption and increased permeability, may contribute substantially to oral~     vaccine failure in developing country settings. Other possible causes of oral vaccine~     underperformance include malnutrition, interference with maternal or breast milk antibodies,~     changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is~     to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus~     vaccines is associated with the presence of tropical enteropathy.~   "
113429|NCT01571492|"~     This prospective study is intended to compare the analgesic efficacy, preservation of lower~     extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach~     compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local~     anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.~      The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain~     treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy~     and motor power sparing with greater promotion of early achievement of postoperative~     physical therapy goals.~   "
113430|NCT01571479|"~     The aim of this study was to show that this technique is feasible, safe and easily~     reproducible and to evaluate the selection criteria for a three-port laparoscopic~     cholecystectomy using a 2-mm mini-port.~   "
113431|NCT01571466|"~     30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will~     be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will~     be observed at the Investigation Unit of the study site for one hour following vaccination.~     At week 24 they will stop their HAART until the end of the study.~   "
113432|NCT01571453|"~     This study will be conducted with the aim of investigating the efficacy, safety and~     tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active~     comparator (venlafaxine extended release 150 mg/day).~   "
113433|NCT01571440|"~     The purpose of this study was to determine the effect of soluble corn fiber on calcium~     absorption and retention and gut microflora in adolescent boys and girls.~   "
113434|NCT01571427|"~     Past epidemiological studies have demonstrated that larger social networks, or more frequent~     social interactions, could have potential protective effects on the incidence of Alzheimer's~     Disease (AD). However, in those studies, indicators of social interactions were often broad,~     and included distinct elements that affected cognition and overall health. the investigators~     will examine whether conversation-based cognitive stimulations have positive effects on~     general, and domain-specific cognitive functions among the elderly. Face-to-face~     communication will be conducted through the use of personal computers, webcams, and~     user-friendly simple interactive Internet programs to allow participants to have social~     engagement while staying at their home and also for the cost effective execution of the~     study.~   "
113435|NCT01571414|"~     Tuberculosis (TB) is a global public health concern and developing new treatment regimens is~     an important research priority. PA-824 is an experimental TB medication. This study will~     evaluate the safety and tolerability of PA-824 when combined with efavirenz (EFV) or~     ritonavir-boosted lopinavir (LPV/r), which are medications used to treat HIV infection, or~     rifampin (RIF), which is a medication used to treat TB. Study researchers will examine the~     safety and tolerability of these drug combinations and how the medications affect the levels~     of PA-824 in the blood.~   "
113436|NCT01571401|"~     Objectives: The purpose of this study is to find out if a new program can help kidney cancer~     survivors (KCS) increase their physical activity (PA) and improve their quality of life~     (QoL).~      Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer~     Registry. Participants will undergo submaximal exercise testing, a physical function test~     and measures of height and weight, which will be completed at baseline and the end of the~     physical activity program (at 12 weeks). Participants will also complete questionnaires on~     PA and QoL at the baseline, after the supervised portion of the program (at 4 weeks), and at~     the end of the entire program (at 12 weeks). Following baseline assessments, participants~     will be randomly assigned to either: (1) supervised physical activity plus traditional~     exercise counseling or (2) supervised physical activity plus behavioural counseling.~     Participants will be asked to attend six individual supervised exercise and counseling~     sessions over a 4-week period with a PA specialist that eventually tapers to a home-based~     program by the end of the program.~      Implications: The investigators hope that this PA intervention for KCS is feasible and~     results in meaningful improvements in health outcomes that can be translated to public~     health practice.~   "
113437|NCT01571388|"~     The study will determine if there are differences in how dacomitinib is absorbed and~     eliminated between healthy subjects and subjects with mild and moderately impaired hepatic~     function.~   "
113438|NCT01571375|"~     The Aim of the Study is to Measure the Effect of Finnish Physician-staffed EMS Unit~     Treatment Methods on Traumatic Brain Injury (TBI) Patient Prognosis.~      Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to~     compare the results against a historical database to see if the implementation of a HEMS~     unit will improve the prognosis of TBI patients.~   "
113442|NCT01571323|"~     The purpose of this study is to demonstrate that the combined used of low dose of oxytocin~     and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol~     alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing~     elective or emergency lower segment cesarean section under spinal anesthesia were included~     in this study. The patients were randomly allocated to one of three groups of 50 each. The~     oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after~     delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved~     in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period,~     immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 µg~     sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and~     the combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus~     intravenously immediately after delivery of the neonate . The main outcome measures were~     blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics~     and drug related side effects.The volume of blood in the suction bottle was measured, blood~     soaked sponges and added to volume from suction bottle. Hemoglobin values were determined~     both before surgery and 24 h following surgery. Hemodynamic variables were recorded every 5~     minutes during surgery .The need for additional oxytocic therapy, operating time, infusion~     volume given intraoperatively, need for blood transfusion, side effects of study drug and~     any significant puerperal morbidity were also recorded.~   "
113443|NCT01571310|"~     The investigators will explore the effect of omission of breakfast on postprandial~     hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2~     diabetic patients~   "
113444|NCT01571297|"~     The purpose of this study is to evaluate the effects of RM-131 on gastric emptying,~     gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in~     patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed~     to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131~     and placebo) will be administered subcutaneously in a blinded fashion.~   "
113445|NCT01571284|"~     Primary Objective:~      To provide metastatic colorectal cancer patients with access to aflibercept and to document~     the overall safety in these patients~      Secondary Objective:~      To document the Health-Related Quality of Life of aflibercept in this patient population~   "
113446|NCT01571271|"~     Bile duct stones that can't be removed by conventional means can often be removed after~     fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation~     of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser~     (laser lithotripsy). Although both techniques have been used for many years, there are no~     studies comparing the efficacy of the two. The purpose of this study is to find out which~     technique is more effective.~   "
113447|NCT01571258|"~     The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded~     content, intervention strategies and interactive database logic, novel online enrollment,~     and automatic baseline scoring of measures to support a 12 month weight loss SMS~     intervention. The investigators hypothesized that the intervention group would have greater~     weight loss at 6 and 12 months than the control group and increased adherence to SMS would~     be associated with greater weight loss at 6 and 12 months.~   "
113448|NCT01571245|"~     Objective psychophysiologic reactivity data may be useful for predicting post-traumatic~     stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack~     of a clearly superior treatment, a reliable and valid approach to predicting treatment~     response is needed.~      Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to~     predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring~     Freedom/Operation Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD.~     2). Evaluate the clinical utility of psychophysiologic reactivity measures to predict~     psychosocial functioning and health-related quality of life (HRQoL) response among~     OEF/OIF/OND veterans in treatment for PTSD. Exploratory). Develop psychophysiologic,~     neuropsychological, and/or self-report models to predict PTSD symptom response to~     pharmacotherapy, psychotherapy, and combined pharmacotherapy/psychotherapy. The~     investigators will divide psychophysiologic reactivity predictors into two groups: heart~     rate variability and attentional bias (eye gaze tracking and modified Stroop). The~     investigators will collect observational and longitudinal data from a treatment-seeking~     sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central Arkansas Veterans~     Healthcare System (CAVHS) Mental Health Clinics.~   "
113449|NCT01571232|"~     The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone~     implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant~     diabetic macular edema.~   "
113450|NCT01571219|"~     CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc.~     This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion,~     efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess~     the long-term efficacy and safety of multiple doses of CT-P13.~   "
113451|NCT01571206|"~     This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion,~     efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess~     the long-term efficacy and safety of multiple doses of CT-P13.~   "
113452|NCT01571193|"~     In the present study, the investigators will examine and determine whether pomegranate~     extract benefits cognitive abilities in middle-aged and older non-demented volunteers. More~     specifically, the investigators will test the following primary hypothesis:~        1. Non-demented volunteers aged 50-75 who receive a daily dietary supplement of~          pomegranate extract will show improved cognitive performance compared to baseline~          versus those receiving a placebo after one, six, and twelve months.~           The investigators will also explore the following secondary hypothesis:~        2. Cognitive change in the pomegranate intervention group will vary according to genotypes~          found to influence age-related cognitive decline (i.e., apolipoprotein E [APOE]).~   "
113453|NCT01571180|"~     Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned~     preoperatively and one, three, six and twelve months after gastric bypass surgery. The~     purpose of this study is to explore current practice regarding the use of medication and~     medication counseling after RYGB and to examine the changes in dietary pattern before and~     after RYGB.~   "
113455|NCT01571141|"~     Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the~     development of cervical cancer. Persistence of the infection is one of the main factors~     responsible for the invasive progression and women diagnosed with intraepithelial squamous~     lesions are referred for further assessment and surgical treatments which are prone to~     complications. Despite this, there are several reports on the spontaneous regression of the~     infection.~      In this study the investigators will evaluate the effectiveness of a long term~     polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance~     reducing the time exposure to the infection and avoiding the complications associated with~     the invasive treatments currently available.~      Women diagnosed with HPV infection were randomly assigned to receive six months of treatment~     with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same~     period of time.~      The administration of Monogin® has been performed every three days for fifteen days and then~     every fifteen days for the subsequent six months.~   "
113456|NCT01571128|"~     MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a~     gender-specific combination HIV prevention package for youth (aged 15-24) in high burden~     settings. The study aims to pilot a combination package of gender-specific interventions in~     western Kenya in a mobile health delivery format using integrated services delivery.~   "
113457|NCT01571115|"~     INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder~     characterized by difficulty initiating or maintaining sleep, waking early or by~     non-restorative sleep, resulting in losses in the daily functioning of patients, such as~     lack of attention, concentration and memory, fatigue, moodiness and irritability that are~     potentially associated with changes in sleep architecture, especially the reduction in~     slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but~     currently the resistive exercise is an important non-pharmacological intervention known to~     provide enough increase in slow wave sleep, and improve other parameters of sleep, as well~     as reducing symptoms of anxiety that are directly associated with the framework of insomnia.~     OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the~     profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY:~     30 patients will be selected (male and female) with chronic primary insomnia. (Clinical~     diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP.~     The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the~     AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15~     participants, which will hold a resistive exercise and the other stretching exercise. This~     study will consist of three assessments: Pre-intervention (baseline), intermediate Rating (2~     months) and post-intervention (at the end of 4 months). In the program of resistive exercise~     will be held 48 sessions that involve upper and lower limbs, abdominal and paraspinal~     region. It will be initially used a relative intensity 50% 1-RM. After 2 months of training~     intensity will be increased to 60% of 1-RM. Each exercise will be conducted in three sets of~     12 repetitions, at intervals of 30 seconds between sets and one minute between each~     exercise. The total duration of the training session will be approximately 50 minutes.~     Before starting the training, participants will hold for 5 minutes stretching and warming on~     a bicycle ergometer (Life Cycle 9100) or treadmill (Life Fitness 9100) for the same period.~     After the session, the volunteers performed repeated stretches at the start of training. The~     group submitted to follow the practice of stretching protocol performed by Tworoger et al.~     that consist of 48 sessions of stretching for 60 minutes of low intensity, three times a~     week. The session will begin with 5 minutes of walking around the room, followed by 45~     minutes of stretching exercises that involve the upper and lower limbs, 8 to 10 types for~     each region and end with 10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of~     sleep, body composition and maximal repetition test will be analyzed using the software~     Statistica 7.0 (StaSoft, INC). The appropriate statistical test, parametric or~     nonparametric, will be chosen according to the data of the sample groups.~   "
113458|NCT01571102|"~     In this study we investigate whether physiotherapy offers added value in rehabilitation~     after meniscectomy compared with no therapy or a home program. The population consists of~     180 post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients~     received no therapy, the next 60 patients were offered a treatment by their home~     physiotherapist according to our established protocol and the last 60 patients we have~     prepared a home program .~      The physiotherapeutic treatment has been prepared based on scientific literature and own~     experience from the program at Ghent University and internships. It includes exercises to~     promote mobility, strength and stability and exercises to reduce pain and swelling depending~     on the phase of tissue repair and evolution of the patient. This schedule will be given to~     the patient along with the questionnaires at registration of the operation and will serve as~     a guideline for the physiotherapist for the rehabilitation of the patient after surgery.~     Monitoring of the evolution will take place by calling the physiotherapist on regular basis.~      The home program is prepared on the basis of commonly used home exercises after arthroscopy~     and also includes exercises to promote mobility, strength and stability and exercises to~     reduce pain and swelling. The difference with the physiotherapeutic treatment is that there~     is no control and supervision of a physiotherapist and that the treatment is more limited.~     This program is given with the patient along with the questionnaires at registration of the~     operation.~      Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an~     evaluation of the current condition of the patient will happen on the basis of standardized~     questionnaires. Based on the results of these questionnaires, collected at different times,~     we can determine which treatment provides the best rehabilitation after meniscectomy. The~     first (preoperative) questionnaire, given at registration of the operation, is completed and~     given to the nurse of the day hospital on the day of surgery, the other (postoperative)~     questionnaires are sent electronically to the patient's email address and need to be~     returned, after filling up.~      This study spends specific attention to the speed of resumption of work / sports and daily~     activities and the presence or absence of complaints.~   "
113459|NCT01571089|"~     The main interest in this study is to investigate if it is possible to use strategies from~     Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive~     Behavioral Therapy (CBT) for patients with anxiety disorders. For the patients included in~     this study, previous exposure-based treatment should have been unsuccessful (drop-out,~     relapse or lack of positive results after treatment).~   "
113460|NCT01571076|"~     Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal~     embryos before the transfer in IVF treatments in many cases. There is great debate in the~     scientific community as to whether this is an efficient practice in patients of different~     prognosis.~      This prospective and randomized study seeks to study the results of chromosomal diagnosis~     using the new Comparative Genomic hybridization (CGH) arrays technique by practicing~     Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not~     on the other arm in order to compare the results. The investigators will study the ongoing~     pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos~     (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two~     different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male~     severe factor (≥2 million spermatozoids/ml.).~   "
113461|NCT01571063|"~     Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to~     biochemical and histological parameters.~        -  Trial with medicinal product~   "
113462|NCT01571050|"~     The risk of dental fluorosis development is related to the systemic exposure to fluoride~     during enamel formation. Currently, diet and fluoride toothpastes are the main sources of~     fluoride to children at the age-risk for fluorosis development. However, when estimating the~     risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the~     systemic fluoride bioavailability. Since some toothpaste formulations may contain part of~     fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride~     in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult~     volunteers will ingest a standardized dose of total fluoride from commercially available~     toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic~     bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after~     ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.~   "
113463|NCT01571037|"~     Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left~     ventricular assist device (LVAD) implantation and has been shown to adversely affect~     peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and~     post-operatively are limited. Inhaled milrinone has been shown in several small human~     studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics.~      Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may~     provide pulmonary artery vasodilation and therefore improved RV function in patients with~     end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation~     or as destination therapy.~      Specifically, we aim to:~        -  demonstrate safety of inhaled milrinone in this patient cohort~        -  demonstrate efficacy of inhaled milrinone in this patient cohort~   "
113464|NCT01571024|"~     The purpose of this study is to establish the safety and tolerability of BKM120 when~     combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this~     combination in advanced solid tumors including metastatic pancreatic cancer.~   "
113465|NCT01571011|"~     The purpose of the study is to determine whether a culturally tailored, low-cost, primary~     care/internet based depression prevention intervention (CURB) is superior to wait-list~     control for African American and Hispanic youth in terms of depression-related outcomes. It~     is hypothesized that compared to teens in the wait-list control condition, teens in the CURB~     program will exhibit lower levels of depressed mood and/or more rapid changes in mood during~     the follow-up time.~   "
113468|NCT01570972|"~     Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are~     evidence-based treatments for first episode psychosis. However, like all treatments for~     psychotic disorders, neither MFG nor GCBT are perfect—some individuals who receive these~     interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms~     through which these interventions produce their clinical benefits and identifying the~     factors that may maximize an individual's response to MFG and GCBT could improve the~     clinical benefits facilitated by these two interventions.~   "
113469|NCT01570959|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.~   "
113470|NCT01570946|"~     Primary prevention of diabetes is of paramount importance in both developed and in~     developing countries. Several studies including the Indian Diabetes Prevention Programmes~     have shown that Lifestyle modification in people with prediabetes can reduce the progression~     to diabetes by 58%. However, there are two main problems in applying diabetes prevention~     strategies to the population as a whole. (1) Trial based interventions are unrealistic on a~     population level in any country. (2) The oral glucose tolerance test applied so far to~     identify those at high risk is a poorly reproducible and time consuming test both for the~     participant and for health care workers. Hence more practical means of defining individuals~     who would benefit from lifestyle intervention are required.~      The current study proposes a prevention strategy that will employ a lifestyle modification~     programme delivered by text messaging in both India and the UK.Subjects will be identified~     based on the HbA1c measurement instead of the oral glucose tolerance test. The study will~     also assess the efficacy, acceptability and cost effectiveness of mobile phone based~     intervention both in India and the UK.~      Messages will be based to deliver education, treatment targets, advice, support and~     motivation. Subjects will be invited to participate and, once recruited, will be randomised~     to usual care or the SMS intervention group.~      Usual care will consist of a one-to-one 30 minute interview, conducted by the research team,~     delivering personalised diet and exercise advice.~      The intervention group will undergo the same initial interview and, in addition, will~     receive 3 times weekly text messaging with education, advice, support and motivation. These~     messages will be personalised to individual targets set at the initial interview.~      Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical~     activity / Cardiovascular risk factors/and quality of life.~      The study programme is compatible with major initiatives in both the UK and India for the~     prevention of diabetes and cardiovascular disease (CVD).~   "
113471|NCT01570933|"~     Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require~     non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal~     interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows,~     through an oesophageal catheter, to record the electrical activity of the diaphragm and~     thereby synchronize breaths from the ventilator on the inspiratory efforts of the child.~     Moreover, the pressure support delivered by the ventilator may be proportional to the~     diaphragmatic effort developed by the child. This mode, associated with the interface~     Miniflow®, could increase the comfort of the child by allowing a more efficient~     synchronization and reducing its respiratory work. To our knowledge, this ventilation mode~     with this interface has not been evaluated in the postoperative period of cardiac surgery in~     the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory~     mode and evaluate its influence on ventilatory parameters of this category of infants.~   "
113472|NCT01570920|"~     Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3~     months. The physical training program was based on walking.~   "
113473|NCT01570907|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 25 mg Tablet under fasted conditions.~   "
113474|NCT01570894|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Quetiapine Fumarate 25 mg Tablet under fed conditions.~   "
113475|NCT01570881|"~     Delirium is common complications in postoperative critically ill patients. However the~     mechanism of postoperative delirium is not well understood.The investigators designed a~     prospective observational study to investigate the association of perioperative plasma~     melatonin levels with postoperative delirium and general anesthesia. The investigators~     included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia~     in an academic tertiary care hospital. The investigators measured plasma melatonin levels 4~     times and assessed postoperative delirium using Confusion Assessment Method for the~     intensive care unit (CAM-ICU).~   "
113476|NCT01570868|"~     The goal of this clinical research study is to learn if ponatinib can help to control~     Chronic Myeloid Leukemia (CML) in accelerated phase. The safety of this drug will also be~     studied.~      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein~     responsible for causing leukemia in certain cells.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the~     location of the clot, this could cause a heart attack, a stroke, severe damage to other~     tissue, or death. A blood clot may occur within 2 weeks after you start taking the drug.~     About 25% (1 in 4) of patients taking the drug form an abnormal clot. Blood clots can occur~     in patients that do not have other known risk factors for forming clots. If you develop a~     blood clot, you will need to stop taking ponatinib. In some cases, emergency surgery could~     be needed to remove the clot and restore blood flow.~   "
113477|NCT01570855|"~     The purpose of this study is to screen chemotherapy drugs currently used to treat lung~     cancer and determine the most effective treatment based on results of chemo sensitivity~     testing on the patients own cancer cells in the laboratory. The results of this screening~     will not influence the patients treatment.~   "
113478|NCT01570842|"~     Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity)~     associated with an increase in acidic and non acidic reflux as well as systemic inflammation~     involving esophageal mucosa, thereby increasing esophageal injury and predisposing to~     subsequent development of Barrett's esophagus (BE)?~   "
113479|NCT01570829|"~     -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in~          treatment of obese patients (BMI 35,0-39,9 kg/m2).~        -  To assess clinical efficiency of Dietressa in the dose of 6 tablets daily within 24~          weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).~   "
113480|NCT01570816|"~     The purpose of this research study is to evaluate the effectiveness of functional electrical~     stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and~     ankle function to improve walking in people with partial paralysis.~   "
113492|NCT01570660|"~     Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the~     investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently~     of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as~     mediators.~   "
113493|NCT01570647|"~     The purpose of this study is to develop a measure - the needle torque test - capable of~     detecting connective tissue abnormalities associated with musculoskeletal disorders.~   "
113481|NCT01570803|"~     Recent stent design improvements focus on decreasing stent fracture rates which can~     negatively impact patency rates by rearranging strut alignment. Although there have been~     several retrospective or registry studies for atherosclerotic femoropopliteal disease in the~     East, there have been few randomized control trial for comparison of stent fracture and~     primary patency between different nitinol stents. Smart stent has the peak-to-valley bridge~     and in-line interconnection. Medtronics company have claimed Complete's stent crowns have~     been configured to minimize crown to crown interaction, increasing the stent's flexibility~     without compromising radial strength. We made the hypothesis that the design of Complete-SE~     stent might be more fracture-resistant or effective for in-stent restenosis, compared with~     Smart stent. On the other hand, 2011 ESC guideline recommended that dual antiplatelet~     therapy with aspirin and a thienopyridine for at least one month is recommended after~     infrainguinal bare-metal-stent implantation. Recent meta-analysis has shown that the~     efficacy of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However,~     still specific data regarding a variety of antiplatelet regimen are limited. To date, there~     is no the study for comparison between clopidogrel and cilostazole in patient undergone~     stent implantation in femoropopliteal lesion. In conclusion, the purpose of our study is to~     examine and compare Primary patency and stent fracture between different two-nitinol stents~     (S.M.A.R.T. CONTROL versus Complete SE) and to compare binary restenosis rate between~     clopidogrel and cilostazol in femoropopliteal arterial lesion.~   "
113482|NCT01570790|"~     The purpose of the study is assess safety, bioactivity, and maximal tolerated dose of~     repeated weekly intravenous infusion of combretastatin A-4 phosphate (CA4P) in patients with~     neovascular age-related macular degeneration~   "
113483|NCT01570777|"~     The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of~     the effectiveness and costs of renal denervation in addition to standardized medical~     treatment compared to medical treatment alone in subjects with resistant hypertension.~     Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous~     system that delivers radiofrequency (RF) energy through the luminal surface of the renal~     artery.~   "
113484|NCT01570764|"~     By including in this study patients with significant worsening of their lung volumes and /~     or their DLCO (carbon monoxide diffusing capacity) in the previous year, on the basis of an~     open retrospective study we recently conducted, we hope to demonstrate that a strategy~     combining prednisone and intravenous cyclophosphamide therapy is accompanied by an increase~     in the frequency stabilization / improvement of lung volumes and / or DLCO of patients at 12~     months of 15% in the placebo and prednisone cyclophosphamide 50% in cyclophosphamide and~     prednisone.We also hope to demonstrate significant decrease in the number of patients~     excluded for failure in the CYC arm as compared to the placebo arm.~   "
113485|NCT01570751|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in~     controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.~   "
113486|NCT01570738|"~     Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem.~     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most~     of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in~     the age group of 6 and less and about 1.5% above. The in-lab sleep study using full~     Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep~     Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full~     night PSG, together with long waiting lists for sleep studies, have led to the commonly used~     procedure of split-night for OSAS patients, as well as to the development of a variety of~     ambulatory sleep study systems. The primary study objective is to compare the efficacy of~     the WatchPAT200 (WP200), as an ambulatory device for aiding in the diagnosis of sleep~     disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a~     gold standard.~   "
113487|NCT01570725|"~     Background. Preoperative anxiety is a common problem for patients who undergo surgical~     operations, being often associated with a number of negative behaviours during and after the~     surgical experience. Since drug treatments alone have frequently proved to be inadequate to~     reduce stress and anxiety in surgical contexts, in the last decades there has been an~     increased interest in non invasive complementary and alternative medical therapies (CAM),~     including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension~     during pre and post operative phases. Virtual reality can be considered an innovative form~     of e-health-based CAM therapy having gained recognition as a means of attenuating pain~     during medical procedures. VR reduces distress and pain perception by providing a~     particularly intense form of immersive distraction that taxes the patient's limited~     attention capacity, resulting in the withdrawal of attention from the real, noxious,~     external stimulus with a subsequent reduction in pain and stress.~      Objective. The aim of this study is to test the efficacy of a small, portable and immersive~     virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory~     surgical operations under local or regional anaesthesia.~   "
113488|NCT01570712|"~     As mental health care shifted from state psychiatric hospitals to the community in France~     and western countries, the mental health system became inevitably involved in housing as it~     strove to meet the broader psychosocial needs of consumers. Simultaneously, as many~     consumers found themselves unable to find stable living in the community and struggling with~     addictions, they became a significant subgroup within a larger homeless population, which~     has received increasing policy attention over the past three decades. There are two distinct~     service models for adults who have severe mental illness and are homeless: the residential~     continuum model and the Housing First model.~   "
113489|NCT01570699|"~     The main objective is to compare the genotypes of the COMT Val158Met polymorphism between~     opiate-users and opiate-dependent subjects. The secondary objective is to constitute a~     sample of opiate-users without any lifetime opiate dependence.~   "
113490|NCT01570686|"~     The purpose of this study is to evaluate the effect of food on aliskiren's efficacy,~     pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light~     meal versus fasted conditions.~   "
113491|NCT01570673|"~     What are we doing? A pilot research study is planned to take place within the Pediatric~     Urology program at McMaster Children's hospital starting this spring/summer 2012. The pilot~     study will compare standard individual teaching that occurs in pediatric urology clinic~     about bladder re-training and achieving healthy bladder and bowel habits to a group teaching~     session. The group teaching session will be one hour in length and include the same content~     taught in pediatric urology clinic and provide more time for the children to ask questions,~     demonstrate and practice different exercises and talk about some of the challenges~     associated with having problems with their bladder. The group teaching session will be~     approximately one hour in length and occur weekly in the evenings for 12 to 15 weeks. Study~     participants will be asked to attend either one group teaching session or one individual~     teaching session which will occur in regular pediatric urology clinic. Parents will be asked~     to complete a demographics questionnaire at the start of the study and child participants~     will be asked to complete 2 short questionnaires about symptoms and quality of life before~     and after either individual or group teaching sessions. At the 3 month follow up, parents~     and child participants will also be asked to fill out an evaluation form of the session~     received. Children between the ages of 6 and 10 years old and a diagnosis of nonneurogenic~     lower urinary tract dysfunction will be asked if they would like to participate.~      Why are we doing it? Some of the symptoms of bladder dysfunction include incontinence~     (wetting), recurrent urinary tract infections, frequency (having to pee a lot) and urgency~     (having sudden urges to pee). These symptoms can affect a child's physical and~     emotional/mental well-being. Treatment includes improving bladder habits through bladder~     re-training and improving bowel habits through treatment and management of constipation as~     well as establishing a bowel routine. Children are taught about their urinary tract system~     and what they need to do to improve and maintain its health. Children are asked to void~     (pee) every 2 hours, double void and drink more water. Sometimes they also need to take~     medications. Often in a busy clinic, parents are taught what the child needs to do and~     expected to return home and implement the bladder re-training instructions. Participation of~     the child during these visits varies. However, participation and engagement of the child in~     bladder re-training is crucial for success. Also, little time is spent on the impact of~     bladder dysfunction on the lives of these children. Many children do not want to follow the~     instructions on bladder re-training because they are worried about what their peers may say.~      What do we hope to accomplish? The purpose of this study is to assess the feasibility of a~     group teaching session and evaluate the preliminary effectiveness of the session.~     Questionnaire results will be compared before and after the teaching sessions and between~     the individual and group teaching groups. Evaluation forms will provide feedback about the~     teaching sessions which will help determine the strengths of the sessions and improvements~     that could be made to improve the quality and effectiveness of future treatment. Outcomes~     that will be measured include symptoms and quality of life. This pilot study will also~     provide important information related to symptoms and quality of life for these children.~   "
114910|NCT01552070|"~     The purpose of this study is to investigate the change of extravascular lung water (EVLW),~     cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute~     respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.~   "
113494|NCT01570634|"~     Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to~     life-threatening colitis. Illness from C. difficile most commonly affects patients in~     hospitals and long-term care facilities and typically occurs after a patient has received~     antibiotics.~      In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to~     bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce~     severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection.~     This would likely occur in conjunction with neutralization of C. difficile toxins A&B by~     CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A&M University~     supports this hypothesis.~      The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care~     therapy will reduce the duration and severity of diarrhea and other symptoms in patients~     with C. difficile infection.~   "
113495|NCT01570621|"~     Achalasia is a rare esophageal motility disorder, characterized by incomplete lower~     esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and~     aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and~     chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin~     injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral~     endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal~     invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM~     in our department, and to assess short-term and long-term efficacy of POEM by using Stooler~     score, Echardt score, esophageal barium and manometry.~   "
113496|NCT01570608|"~     Ranibizumab has been proven to be effective in large multicentre studies. However, the~     injections have to be repeated monthly. A combined therapy with the established photodynamic~     therapy might even be more effective, less intravitreal injections might be necessary due to~     a synergistic effect.~      The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in~     combination with verteporfin photodynamic therapy under a new time regime is an effective,~     safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV)~     secondary to Age-Related Macular Degeneration (AMD).~   "
113497|NCT01570595|"~     The purpose of this study is to evaluate the first web-based cessation program developed~     expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate~     the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and~     (2) to complete a prospective, randomized controlled trial comparing the efficacy of the~     online program to standard care with a primary outcome of 3 month point-prevalence~     abstinence.~   "
113498|NCT01570582|"~     purpose Primary endpoint~        -  To evaluate the 24 month disease free survival Second endpoints~        -  To evaluate the 24 month overall survival To analyze the toxicity and the quality of~          life~   "
113499|NCT01570569|"~     The investigators objectives were developing mini dose five-drug cocktail regimen to~     evaluate potential drug-drug interactions associated with use of a cocktail of caffeine,~     losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2,~     CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.~   "
113500|NCT01570556|"~     When considering occult infections during the diagnostic workup of inflammation in~     Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential~     site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on~     hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a~     relevant issue because the urinary tract is often overlooked as a source of infection in~     dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms~     in HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence~     of low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to~     voiding, which is reduced or absent in these patients. Persistence of asymptomatic~     bacteriuria and UTI may be related to higher levels of inflammatory markers in HD~     population. In view of the association between cardiovascular disease and cardio-vascular~     and all-cause mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels~     in HD patients, the investigators questioned whether presence of asymptomatic UTI could~     contribute to elevated levels of inflammatory markers in patients with ESRD on maintenance~     HD therapy. Such a finding would provide a potential link between a treatable infection and~     a potential cardiovascular risk factor in this population.~   "
113501|NCT01570543|"~     The purpose of the study is to improve image quality, increase speed of scanning and to see~     how well certain products test by scanning people who have an orthopedic hip or knee~     metallic implant.~   "
113502|NCT01570530|"~     The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both~     during preoperative and postoperative period), as prophylaxis against postoperative atrial~     fibrillation after cardiac surgery, in a valve disease patient population (with or without~     associated coronary artery disease), with no previous history of atrial fibrillation and not~     receiving beta-blocking drugs.~   "
113503|NCT01570517|"~     The purpose of this study is to evaluate the safety and potential benefits of the~     interatrial septal defect (IASD) System in patients with heart failure with preserved~     ejection fraction.~   "
113504|NCT01570504|"~     Ivermectin is currently the best drug to cure strongyloidiasis, but the standard single~     dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be~     fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to~     eradicate the parasite.~      Aim of this study is to define the most effective dose schedule of ivermectin to cure~     strongyloidiasis.~   "
113522|NCT01570270|"~     In this study the investigators aimed at verifying whether consumption of a sheep cheese,~     naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic~     acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild~     hypercholesterolemic subjects.~   "
113523|NCT01570257|"~     In treating idiopathic normal pressure hydrocephalus with a shunt there is always a risk of~     underdrainage or overdrainage. The hypothesis is tested whether treatment of patients with~     an adjustable valve preset at the highest opening pressure (OPV), leads to comparable~     clinical results with less subdural effusions than in a control group with an opening~     pressure preset and kept fixed at a low pressure level.~   "
113524|NCT01570244|"~     This study will investigate possible effect of multiple oral doses of BI 201335 on the~     steady state pharmacokinetics of ethinylestradiol and levonogestrel~   "
113505|NCT01570491|"~     No sample size estimation methodology currently exists for the right-censored count data~     models. We expect less number of attempts in the ultrasound group a 20 % difference between~     the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level~     of significance with a power of 0.8, we will require a minimum of 20 patients per~     group,therefore we plan to recruit 40 patients in total. Patients who consent to receive~     spinal anesthesia (as opposed to some other anesthetic technique) and who meet the~     inclusion/exclusion criteria for the study (given below) will be randomized on day of~     surgery after obtaining informed consent to either ultrasound-guided or standard spinal~     anesthesia technique. A block randomization scheme with random block sizes ranging from 2-8~     patients will be used. The outcomes will be recorded by a third party observer in the block~     room/operating room who might be a nurse or resident or clinical research fellow not~     directly involved with performing the block. The post procedure outcomes will also be~     recorded by a clinical research fellow or resident who was not directly involved with~     performing the block. The analysis will be conducted by a statistician who will be blinded.~   "
113506|NCT01570478|"~     The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler®~     100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation~     b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in~     post-dose peripheral airway resistance) in patients with asthma.~   "
113507|NCT01570465|"~     All patients receiving induction, consolidation and salvage chemotherapy, and autologous or~     allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310~     protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other~     microbiologically documented bacterial infections, pneumonia, other invasive tissue~     infections and viral diseases) during each chemotherapy and transplant and the impact of~     these infections on survival will be evaluated until 24 months from the diagnosis of AML.~   "
113508|NCT01570452|"~     Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology.~     Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with~     metastatic disease even though it is expressed in most tumor states. Our purpose is to~     analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its~     expression as a potential biomarker of cancer disease in patients surgically treated for~     benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from~     recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin~     expression by histology, immunohistochemistry, ELISA and Western blotting.~      If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue~     as well as in the regional lymph nodes it might be used as a complement in investigating~     suspected locally advanced cancer.~   "
113509|NCT01570439|"~     Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens~     (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.~      Methods: The panel of candidate peptides are synthesized and tested for their ability to~     induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable~     for the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from~     HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate~     peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell~     pulsed with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes~     were negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for~     their peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These~     conditions are completely performed in in-vitro system. Importance in medicine: If one could~     identify the peptide epitopes from novel Oncoantigens, it is applicable for clinical trials~     of cancer vaccination.~      Benefits & Risks : There is no risk except for the matter of venipuncture in each~     individuals.~      The ideal target molecules for cancer vaccination are thought to be selectively expressed in~     tumor cells, but not in the normal cells, with high frequent and homogenous expression~     within tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these~     characters as ideal target molecules for the cancer vaccination and are highly expressed in~     a variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101~     haplotype is most frequent in Singaporean, it is essential to indentify the~     HLA-A1101-restriced peptides derived from these Oncoantigens to develop cancer vaccination.~   "
113510|NCT01570426|"~     The purpose of this research is to learn more about how children with mental health~     problems, including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD),~     and generalized anxiety disorder (GAD), differ from children without these problems. The~     investigators want to understand how these 4 groups of children differ in brain activity,~     function, and structure.~   "
113511|NCT01570413|"~     This study is designed to determine whether the pelvic examination (including bimanual and~     speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower~     abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with~     the chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and~     positive HCG will be considered for this non-inferiority-designed clinical trial. All~     patients who present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and~     have had serum or urine HCG testing and a formal ultrasound by a credentialed emergency~     physician or radiology technician as part of standard of care will be screened for further~     eligibility. Those patients with intra-uterine pregnancies < 16 weeks gestation seen on~     ultrasound and meet inclusion criteria will then be asked to provide informed consent to~     participate in the study. Randomization will occur after consent has been obtained. Half of~     the patients will be randomized to receive pelvic examinations and the other half will not.~     Further care will be determined by the treating attending physician. The primary outcome~     will be a composite morbidity endpoint at 30 days, including return visits to the ED,~     emergency surgery, need for transfusion, infection, or other missed source of bleeding/~     pain. Secondary outcomes of interest include ED throughput time, and patient satisfaction.~   "
113512|NCT01570400|"~     The purpose of this study is to determine whether an internet-based treatment program,~     consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces~     symptoms of social phobia among a population diagnosed with this disorder.~   "
113557|NCT01569815|"~     The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and~     its metabolites in subjects with mild to moderate renal impairment and to evaluate the~     safety of LCZ696 in this population.~   "
113513|NCT01570387|"~     This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the~     standard melphalan chemotherapy-based regimens is either not recommended or is not their~     preference.~      Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the~     functioning of the immune system. So, in theory, it may reduce or prevent the production of~     the amyloid protein. Pomalidomide is not currently FDA-approved for AL Amyloidosis.~     Pomalidomide is chemically similar to thalidomide and lenalidomide, both of these drugs have~     been approved by the FDA for treatment of patients with multiple myeloma (MM), a disease~     similar to AL Amyloidosis.~      Participants in this study will receive pomalidomide and dexamethasone. Phase I is a~     dose-escalation study and dose escalation will proceed through 3 dose-levels according to~     standard rules in which dose levels are started sequentially after complete evaluation of~     the occurrence of dose-limiting toxicities. In the Phase II portion, participants will~     receive pomalidomide and dexamethasone using the defined maximum tolerated dose.~   "
113514|NCT01570374|"~     The purpose of this study is to determine whether internet-administered cognitive behavior~     therapy is a feasible treatment for generalized anxiety disorder.~   "
113515|NCT01570361|"~     The objective of this study is to determine whether early radiofrequency (RF) ablation~     treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family~     (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial~     fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug~     therapy (either rate or rhythm control) using current AF management guidelines.~   "
113516|NCT01570348|"~     This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in~     treating patients with refractory Crohn's Disease. We will select patients with severe~     Crohn's Disease and active inflammation despite the best medical and surgical treatments.~     These patients must be healthy enough to undergo a transplantation procedure. They cannot~     have an active infection, and their heart, lungs, kidneys, and liver cannot be failing. The~     transplant procedure starts with chemotherapy and a small dose of radiation, to weaken a~     patient's immune system so that it will accept bone marrow cells from another person. After~     that other person's bone marrow cells are given to the patient, immune suppressive medicines~     are given to prevent the new cells from being rejected and to stop those cells from damaging~     the patient. After the new donor cells start to work, blood counts will rise and the new~     immune system will start to grow. During this time, there is a risk of infection.~     Antibiotics and anti-viral drugs will be given to prevent infection. When the new donor~     cells are well-established, immune suppressive medicines are discontinued. We will examine~     parts of the intestine that were inflamed before the start of the transplant procedure, to~     be sure the Crohn's Disease has disappeared after the transplant. Patients will be formally~     evaluated for Crohn's activity at around 100 days after transplant, and yearly after that~     for 5 years.~   "
113517|NCT01570335|"~     The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the~     perinatal department.~   "
113518|NCT01570322|"~     Study the factors that explain Health-Related Quality of Life (HRQL) in patients with~     Alzheimer disease including:~        -  The influence of the environment (physical and human) on Health-Related Quality of Life~          (HRQL),~        -  The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),~        -  The influence of formal and informal help mobilized,~        -  The influence of interactions patient - caregiver on Health-Related Quality of Life~          (HRQL),~        -  The influence of the ratio necessary cost on available resources on Health-Related~          Quality of Life (HRQL)~   "
113519|NCT01570309|"~     Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular~     disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and~     prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living~     populations in the United States especially in urban, and multi-ethnic low income Northern~     cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk~     and evaluate outcomes have not been performed.~      The investigators propose a double-blind, randomized wait-list control trial in subjects~     with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim~     1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry~     (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to~     measure levels of inflammation before and after treatment with Vit D replacement therapy.~     These aims will test the hypotheses that Vit D repletion will improve endothelial function~     and reduce the levels of detectable inflammation in the plasma of these subjects.~   "
113520|NCT01570296|"~     The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib~     and BKM120 will be determined.~   "
113521|NCT01570283|"~     The subjects eligible for this trial have a type of blood cell cancer, other blood disease~     or a genetic disease for which they will receive a stem cell transplant. The donor of the~     stem cells will be either the subject's brother or sister, or another relative, or a closely~     matched unrelated donor. The Investigators are asking subjects to participate in this study~     which tests if blood cells from the subject's donor that have been grown in a special way,~     can prevent or be a effective treatment for early infection by five viruses - Epstein Barr~     virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6~     (HHV6).~      Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious~     life-threatening infections in patients who have weak immune systems. It can affect the~     lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and~     eyes.~      CMV can also cause serious infections in patients with weak or suppressed immune systems. It~     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,~     the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body.~     In healthy people CMV rarely causes any problems because the immune system can keep it under~     control, but after a transplant, the risk of developing CMV disease is much higher because~     the immune system is so weak.~      EBV is the virus that causes glandular fever or kissing disease. It is also a life long~     infection like CMV that is normally controlled by immune system. When immunity is weak, the~     virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of~     cancer called lymphoma.~      BKV is a virus that usually causes symptoms of a common cold such as fever and normally does~     not cause problems. If the immune system is weakened in some way, for example following a~     bone marrow transplant, then BKV can cause life-threatening infections affecting mainly the~     kidneys, bladder, and urinary tract.~      HHV6 is another virus that infects most people in childhood causing symptoms like fever,~     diarrhea and rash. Like CMV, EBV, and BKV, HHV6 remains in the body for life and can cause~     problems when the immune system is weakened. When this occurs the virus can affect many~     organs including the brain, lungs, heart, kidney and gastrointestinal tract.~      The Investigators want to see if they can use a kind of white blood cell called T~     lymphocytes (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the~     early stages of reactivation or infection.~      The Investigators have grown T cells from the subject's stem cell donor in the laboratory in~     a way that will train them to recognize the viruses and control them when the T cells are~     given after a transplant. This treatment with specially trained T cells (also called~     cytotoxic T cells or CTLs) has had activity against three of these viruses (CMV, EBV and~     Adenovirus) in previous studies. In this study the Investigators want to see if they~     increase the number of viruses that can be targeted to include BKV and HHV6 using a simple~     and fast approach to make the cells.~   "
114911|NCT01552057|"~     The purpose of the study is to assess the effectiveness and safety of duloxetine in~     participants with fibromyalgia.~   "
113525|NCT01570231|"~     Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the~     heart. This study aims to evaluate the feasibility, safety and initial efficacy of using~     briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in~     octogenarians with symptomatic intracranial arterial stenosis.~   "
113526|NCT01570218|"~     OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer~     in patients with breast's or gynecology's cancer, during the radiotherapy treatment.~   "
113527|NCT01570205|"~     The objective of the study is to investigate safety, tolerability, and pharmacokinetics of~     XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to~     healthy male volunteers~   "
113528|NCT01570192|"~     The primary objective of this study is to demonstrate a low rate of emergence of antibiotic~     resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized~     patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem~     administered as a prolonged infusion in combination with a parenteral aminoglycoside plus~     tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 -~     control arm).~   "
113529|NCT01570179|"~     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight~     or the ideal body weight?~      The main objective of the trial is to compare in patients undergoing bariatric surgery the~     efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on~     real body weight (control intervention) with dosing based on ideal body weight (experimental~     intervention). The research hypothesis is that both dosing regimens are equivalent~      The secondary objective of the trial is to compare the impact of the depth of neuromuscular~     blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very~     deep block (TOF count = 0 and PTC < 5)~   "
113530|NCT01570166|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence~     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5~     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC~     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival~     after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out~     only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the~     poor functional liver reserve or because of widespread intrahepatic recurrence. In the past~     two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment~     modality and has attracted great interest because of its effectiveness and safety for small~     HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported~     a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is~     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors~     are usually detected when they are small and PRFA causes the least deterioration of liver~     function in the patients. To the best of our knowledge, there has been no report published~     in the medical literature comparing the efficacy of repeat hepatectomy with PRFA for~     recurrent HCC. The aim of this retrospective study is to compare the outcome of repeat~     hepatectomy with PRFA for small recurrent HCC after partial hepatectomy.~   "
113531|NCT01570153|"~     The purpose of this study is to evaluate the ability of a non-invasive monitor that measures~     how much fluid is in the body as well as various blood tests for their ability to predict~     worsening kidney function in patients with heart failure.~   "
113532|NCT01570140|"~     Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch~     population, the investigators expect further growth of number of known diabetes patients.~     The economic burden with this increase will be enormous, the healthcare system is under~     increasing pressure to provide better but more time efficient service to more people with~     limited human resources. the investigators hypothesize that, by increasing the patients~     self-management by offering remote care services, this reduction of the individual caseload~     can be achieved.~      Objective: Primary objective is to test the hypothesis that the consistent use of a web~     portal and its educational content and the possibility to review personal diabetes related~     data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an~     improvement quality of life.~      Study design and methods: In this Prospective observational cohort study the investigators~     examine the effect of the voluntarily use of a web portal and its educational content. The~     primary end point is health related quality of life. We predefined a clinically relevant~     difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related~     distress and well being and a selection of clinical measurements, number of contacts with~     health care provider and the amount of prescribed medication. The participants are being~     followed for 1-year and the data will be collected at baseline, after 6 months and 12~     months.~   "
113533|NCT01570127|"~     The purpose of this study is to determine whether acupuncture treatment(Individualized &~     Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment)~     and also whether individualized acupuncture is more effective than standardized acupuncture.~   "
113534|NCT01570114|"~     Self-expanding metallic stent placement is a safe and effective endoscopic procedure~     increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and~     plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and~     tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages~     over non-covered stents, including the possibility of retrieval and limited local tissue~     reaction, while providing alleviation of obstruction at possibly lower costs. Only few~     reports of fully covered metal stent placement in patients with benign colorectal strictures~     are available in the literature. The aim of this study was to assess the effectiveness of~     FCSEMS in the management of the colonic benign strictures.~   "
113535|NCT01570101|"~     The primary objective for this clinical study is to assess the role of the CE Marked Sapheon~     Closure System in closure of incompetent great saphenous veins GSV in a routine clinical~     setting.~   "
113558|NCT01569802|"~     The primary aim of this study is to measure, document and compare recall rates of~     two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of~     2D mammography in a screening population. This study will compare recall rates for both~     non-cancer and cancer cases.~   "
113536|NCT01570088|"~     Folic acid is the synthetic form of vitamin folate. Because of its high stability and~     bioavailability, it is the form of folate added to bread in Canada to reduce birth defects.~     There are health concerns about long-term folic acid consumption. Another form of folate,~     L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these~     health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the~     investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan~     to conduct a randomized trial to compare the bioavailability of bread fortified with~     L-5-MTHF versus folic acid.~      The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell~     folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.~   "
113537|NCT01570075|"~     Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global~     cause of cancer-related death. With an increase in life-expectancy of the general~     population, the number of elderly with HCC is expected to increase. Current curative~     treatment options for HCC include: liver transplantation, liver resection (LR) and local~     ablation therapy. Liver transplantation is a good treatment for HCC within the Milan~     criteria (single HCC ≤ 5 cm or up to 3 nodules each < 3 cm). As a consequence of the lack of~     liver donors, one relative contraindication for liver transplantation is age over 65 years,~     or the protocol requires elderly patients to have very good general health before they can~     be put on a transplant list. Transcatheter arterial chemoembolization (TACE) is used more~     commonly for the treatment of intermediate and advanced-staged HCC, while liver resection~     and local ablation therapy are used for early-staged HCC. Amongst the local ablative~     therapies, radiofrequency ablation (RFA) is most widely used. It has the advantage of~     minimally invasiveness, making it the first-line treatment for small HCC in patients with~     compromised liver function or associated severe medical conditions.~      Elderly patients are more likely to have poor general conditions and associated medical~     diseases. RFA has the advantage of being less invasive and it causes less pain, less blood~     loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor~     track seeding may happen. Several studies have demonstrated the safety of LR for elderly~     patients. There is no good evidence in the medical literature to support whether RFA or LR~     is a better treatment for elderly patients with HCC.~   "
113538|NCT01570062|"~     This study is focused on the effects of HEPA filtration to reduce exposures to~     combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health~     benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of~     CDAP, specifically traffic and residential wood combustion.~      Specifically, the purpose of this study is to evaluate the ability of portable high~     efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution~     indoors and to improve subclinical indicators of microvascular function and systemic~     inflammation among healthy adult participants.~      The investigators hypothesize that HEPA filter use will help decrease indoor concentrations~     of CDAP thereby helping to mitigate the associated cardiovascular risks.~   "
113539|NCT01570049|"~     The purpose of this study is to determine whether bendamustine HCl for injection is safe and~     effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.~   "
113540|NCT01570036|"~     The study will be a multi-center, prospective, randomized, single-blinded,~     placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte~     macrophage-colony stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target~     study population is node-positive (NP) (or node-negative [NN] if negative for both ER and~     PR) breast cancer patients with HER2 1+ and 2+ expressing tumors who are disease-free after~     standard of care therapy. Disease-free subjects after standard of care multi-modality~     therapy will be screened and HLA-typed. E75 is a CD8-eliciting peptide vaccine that is~     restricted to HLA-A2+ or HLA-A3+ patients (approximately two-thirds of the US population).~   "
113541|NCT01570023|"~     This study is a multisite, randomized clinical trial to determine the effectiveness of an~     8-week rehabilitative exercise regime performed by patients with swallowing problems, termed~     dysphagia, compared to a control group of patients with swallowing problems who do not~     exercise, but receive standard clinical care. One hundred male and female patients will take~     part in this study from eight participating facilities around the country.~   "
113542|NCT01570010|"~     The aim of this study to examine whether an intensive dietary intervention affects health~     measures and development of lifestyle diseases in colorectal cancer survivors.~   "
113543|NCT01569997|"~     Introduction: Epidemiological data show that in France only half of patients with Alzheimer~     disease are currently diagnosed in the general population. The absence of early diagnosis of~     dementia reduces the opportunities of patients to receive optimal care. One of the~     consequences of undiagnosed dementia is inadequate use of emergency care units.~      The main objective: The main aim of this study is to evaluate the impact of a systematic~     case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of~     hospitalization in emergency care units.~      Secondary objectives:~      To assess the impact of systematic tracking of dementia cases on the:~        -  Quantity and quality of drug-prescription~        -  Appropriateness of hospitalizations~        -  Prevalence of neuropsychiatric symptoms~        -  Dependency~        -  Quality of life~        -  Burden of nursing staff working conditions~        -  Planning of specific therapeutic measures~        -  Overall health care costs~   "
113544|NCT01569984|"~     This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging~     (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal~     metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to~     SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of~     bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription~     dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks.~     Total SBRT dose will be determined by size of target lesion, liver sparing and~     organs-at-risk dose constraints. DCE-CT, CEUS and Quantitative US will be performed within 7~     days prior to the first dose of bevacizumab, after the second dose of bevacizumab and within~     7 days of completing SBRT.~   "
113586|NCT01569438|"~     The purpose of this study is to assess the efficacy of a single dose level of AF-219 in~     female subjects with moderate to severe pain associated with interstitial cystitis/bladder~     pain syndrome (IC/BPS) after 4 weeks of treatment.~   "
113545|NCT01569971|"~     Sickle cell disease (SCD) is a debilitating genetic disorder affecting 70,000-100,000~     Americans. It is frequently associated with very serious medical complications. For children~     with SCD, successfully transitioning to adult care is a vital step in ensuring continuity of~     care, managing their disease, and improving their health outcomes. Transition programs have~     been created to facilitate the transition process. However, few studies have assessed~     transition readiness and whether transition program components meet the transition needs of~     patients and families.~      The purpose of this study is to explore transitioning from pediatric care to adult care and~     to assess components of the SJCRH SCD Transition Program from three perspectives:~     adolescents with SCD, their caregivers, and young adults with SCD who have transitioned to~     adult care. Data collection methods will include focus groups, questionnaires, and~     checklists. Qualitative data analysis procedures will be used to examine the data.~   "
113546|NCT01569958|"~     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by~     progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons,~     the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal~     chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment,~     modestly slow disease progression.~      Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation~     that is currently studied as a possible therapeutic tool for several neurological and~     psychiatric diseases and has been found safe and well tolerated. Based on experimental~     evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability~     and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation,~     one of postulated pathophysiological mechanisms in ALS.~      This study will investigate if transcranial direct current stimulation of motor cortex is~     useful in delaying disease progression and is well tolerated in ALS patients.~   "
113547|NCT01569945|"~     What is the best medication for hormonal stimulation in cycles with high intra-uterine~     insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days)~     or daily injections with Human Menopausal Gonadotropin (Menopur)?~   "
113548|NCT01569932|"~     This study will document the cognitive (mental) and functional abilities of newly diagnosed~     cancer patients. The study will also examine the changes in cognitive and functional~     abilities during and after chemotherapy (your cancer treatment).~      A comprehensive set of questionnaires and tasks, or assessments, have been put together in~     order for doctors and nurses to learn more about the day to day functioning of newly~     diagnosed adult cancer patients. The investigators would also like to follow up with the~     same adult patients, during and following completion of their cancer treatment, to learn~     about the kinds of treatments they received and how their cognitive status and level of~     participation in activities of daily living has changed. With follow-up assessments, doctors~     and nurses can learn more about the complications or health problems that adult patients may~     experience as a result of undergoing cancer therapy. This is a study involving two visits.~     The first visit occurs within two weeks before starting your cancer therapy, specifically~     chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.~   "
113549|NCT01569919|"~     This study is for patients with malignant mesothelioma of the lung lining (called pleura)~     who are planning to have pemetrexed-cisplatin chemotherapy.~      We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin~     chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This~     vaccine has been used in combination with chemotherapy in other types of cancer and has been~     shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight~     the disease, in a similar way to the immune system fighting infection. In laboratory~     experiments, the vaccine has been shown to stimulate an immune response to a particular~     protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is~     hoped that the vaccine will stimulate the immune system to attack mesothelioma cells~     carrying the 5T4 protein.~      Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with~     mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the~     combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy~     alone.~      Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The~     TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3~     weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks.~     Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the~     planned trial schedule. We aim to recruit 26 patients into the trial over a two year period.~     If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe~     and beneficial in terms of stimulating the immune system, the combination will be tested~     further in larger clinical trials.~   "
113550|NCT01569906|"~     To assess prospectively, the response of moderate to severe atopic eczema to a standard~     course of narrowband ultraviolet B phototherapy by using validated objective and subjective~     scoring systems.~   "
113551|NCT01569893|"~     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,~     centralized and large scale tele-monitoring of blood glucose levels, and whether this~     intervention produces health and economic benefits when introduced without major changes to~     the existing organization of a large treatment care center.~   "
113552|NCT01569880|"~     The purpose of the study is to investigate the relationship between hypoxemia achieved~     during Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial~     blood gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to~     study the effect of slow walk in a hypoxic environment, comparable to slow walking along the~     aisle.~   "
113553|NCT01569867|"~     This study intends to investigate genetic influences on how individuals process statins.~   "
113554|NCT01569854|"~     The study intends to investigate whether genetics influence how individuals respond to~     statins (clinical outcomes and changes in carotid intimal media thickness)~   "
113555|NCT01569841|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the efficacy of insulin decludec with insulin glargine on glycaemic control using~     continuous glucose monitoring in patients with type 1 diabetes.~   "
113556|NCT01569828|"~     An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696~     and its metabolites in subjects with severe renal impairment compared to matched healthy~     subjects with normal renal function~   "
113559|NCT01569789|"~     The autonomic (self-regulating) nervous system is important for the function of many organs~     in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve~     carries incoming information from the nervous system to the brain, providing information~     about what the body is doing, and it also transmits outgoing information which governs a~     range of reflex responses. It plays an important role in the immune system. A part of the~     vagus nerve is reachable for stimulation at specific locations in the ear.~      The purpose of this study is to better understand how different ways of stimulating the~     vagus nerve at the ear can affect a chemical marker of inflammation found in human blood~     that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and~     lupus. This information may lead to in future studies to see if stimulation of the vagus~     nerve can improve inflammation in chronic inflammatory diseases.~   "
113560|NCT01569776|"~     The primary objective of this clinical trial is to determine whether a new amino acid-based~     formula is hypoallergenic as defined by the American Academy of Pediatrics (2000),~     demonstrating that the test formula does not provoke allergenic activity in 90% of infants~     or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a~     commercially available hypoallergenic formula.~   "
113561|NCT01569763|"~     The primary objective of this study is to evaluate the safety and effectiveness of the~     Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial~     ablation in reducing menstrual blood loss at 12 months post-treatment.~   "
113562|NCT01569750|"~     The purpose of this study is to identify if, and at what dose, ibrutinib may be administered~     with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to~     document responses of this combination in patients with newly diagnosed diffuse large B-cell~     lymphoma (DLBCL).~   "
113563|NCT01569737|"~     The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies~     exposed to ella, whether due to failure of the emergency contraception or inadvertent~     exposure during pregnancy.~   "
113564|NCT01569724|"~     Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell~     lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not~     well known. The purpose of this study is to research a carbohydrate metabolism disorder~     associated in bexarotene-induced hypertriglyceridemia.~   "
113565|NCT01569711|"~     Depression is a common, recurrent and disabling disorder. Among patients with a chronic~     course of the disease, 20 to 30% are resistant to antidepressant medications. Among those~     patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients,~     deep brain stimulation (DBS) of nucleus accumbens is considered.~   "
113566|NCT01569698|"~     Limited prospective data is available to compare morbidity and mortality between renal~     replacement modalities in pediatric acute renal failure.~      In the absence of clear standard of care, the choice of the extra renal replacement therapy~     modality is subject to clinical judgement, practical aspects, and costs.~      This study will supply important data about usual modalities of pediatric acute extra renal~     replacement therapy and their impact on patient outcome and renal recovery. An obvious next~     step will be to conduct a randomized controlled trial comparing the different strategies.~   "
113567|NCT01569685|"~     Background: The treatment of traumatised refugees is one of the areas within the field of~     psychiatry with the weakest evidence for the different types of treatment. This is a problem~     for both patients and doctors as well as for society.~      The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants~     from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug~     Sertraline. The evidence for the use of these drugs as treatment for chronically complex~     PTSD in traumatised refugees is however very limited and a large part of the group is~     estimated to be insufficiently treated with this type of medicine. Venlafaxine is an~     antidepressant from the subgroup of dual action product which means that is works on several~     pathways in the brain. Among others it influences the area in the brain that is responsible~     for the enhanced anxiety and hyperarousal experienced by traumatised refugees and which is~     found to be enlarged among patients suffering from PTSD.~      All together there is not sufficient evidence to conclude which type of medical and~     psychological treatment that is most efficient when it comes to the treatment of traumatised~     refugees. Also there is a lack of studies which examines social functioning and the relation~     between psychosocial resources and outcome from treatment. Furthermore there is a lack of~     knowledge of predictors of treatment outcome for the individual patients. This study seeks~     to produce some of this evidence.~      Method: This study is expected to include approximately 150 patients randomised into two~     different groups. The patients are treated with Setraline or Venlafaxine depending on the~     group the randomised to. Patients in both groups are getting the same version of manual~     based Cognitive Behavioural Therapy that is specially adapted to this group of patients. The~     treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and~     social functioning all measured on internationally validated ratings scales.~      Furthermore the study will examine the relation between expected outcome of treatment from a~     range of predictors and the actual treatment results for the individual patient.~      Results: Altogether this study will bring forward new standards for clinical evaluation and~     treatment of traumatised refugees and the results are expected to be used in reference~     programmes/clinical guidelines.~   "
113568|NCT01569672|"~     The Ohio Patient Navigator Research Program (OPNRP) proposes to alleviate disparities in~     relation to the timely diagnosis and treatment of breast, cervical and colorectal cancer in~     Columbus, OH.~   "
113569|NCT01569659|"~     The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a~     standard dose of lurasidone in patients with treatment resistant schizophrenia or~     schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of~     positive symptoms and other components of psychopathology (negative symptoms, general~     psychopathology, anxiety, depression, cognitive function, global function, severity of~     illness and tolerability). Patients must qualify for treatment resistance after two or more~     antipsychotic drug trials to be included in this trial.~   "
113570|NCT01569646|"~     Increased white blood cell count at the onset of an acute ST elevation myocardial infarction~     has been shown to be associated of increased incidence of heart failure and mortality. Now~     monocytes which are a subset of white blood cells may have a prognostic value for patients~     presenting with acute ST segment elevation myocardial infarction. A monocyte count of~     greater than 800/mm3 following acute myocardial infarction has been shown to be associated~     with increased incidence of left ventricular dysfunction. The investigators study would~     retrospectively collect data on patients with ST elevation myocardial infarction, looking~     for an association between high monocyte count and the culprit vessel causing the myocardial~     infarction. The investigators would also investigate whether monocytosis would be a marker~     of poor prognosis.~   "
113587|NCT01569425|"~     In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin~     resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss~     is not required in lean PCOS patients; nevertheless, the influence of meal timing and~     composition on glucose metabolism and hyperandrogenism may have clinical value. In this~     study the investigators investigate the effects of two isocaloric diets with different meal~     timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.~   "
113571|NCT01569633|"~     Objective of this study are:~      1) To determine if medication help extreme preterm infants to tolerate feeding better by~     reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1)~     Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to~     study after parental consent. Infant would be blinded to care givers. Infants will be~     randomized to receive one of three medication for 7-14 days. If infants fail on one~     medication they will be allowed to crossover to other medication. Infant would be allowed to~     treat like other infants. Blindness can be broken if deem necessary by attending~     neonatologist.~   "
113572|NCT01569620|"~     The proposed study seeks to investigate the impact of a culturally targeted print~     educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among~     Hispanics. If, as expected, the addition of culturally targeted materials to best clinical~     practices as compared to a) best clinical practices plus standard materials or b) best~     clinical practices alone leads to higher rates of CRC screening via colonoscopy then the~     culturally targeted print educational materials can be easily disseminated among this~     rapidly growing minority group who have low rates of CRC screening and whose disease is~     detected at later, less curable stages.~   "
113573|NCT01569607|"~     Stroke is a leading cause of morbidity in the U.S. but identification of treatment~     strategies to improve outcome is limited by the incomplete understanding of the mechanisms~     of recovery. M1 reorganization plays a major-role in the recovery of motor deficits~     post-stroke; hence the importance for further development of rehabilitative strategies that~     utilize this potential for recovery. Non-invasive cortical stimulation can enhance the~     beneficial effects of motor training on performance and functional plasticity of motor~     cortex. Among the different approaches used in these studies, Hebbian-type M1 stimulation is~     particularly intriguing, as it seems to be more effective when compared to random M1~     stimulation. There is emerging evidence that motor training or cortical stimulation related~     improvement of function are associated with increases in the grey matter of targeted brain~     areas. While there is therefore some evidence supporting structural reorganization in human~     M1 in response to motor learning and cortical stimulation, the mechanisms underlying these~     changes and their relationship to functional plasticity are not known. A better~     understanding of the sequences of events is critical to development of optimal therapeutic~     interventions to improve recovery following stroke. In Specific Aim 1, we will determine if~     repeated exposure to training combined with Hebbian-type M1 stimulation enhances functional~     M1 reorganization in lesioned M1 of stroke patients. In Specific Aim 2, we will determine if~     repeated exposure to training combined with Hebbian-type M1 stimulation enhances structural~     cortical reorganization in lesioned M1 of stroke patients and to explore whether these~     structural changes are related to the training induced functional cortical reorganization.~     At the completion of this project, it is our expectation that we will have determined the~     effect of Hebbian- type stimulation on both, functional and structural brain reorganization,~     thereby obtaining indirect evidence for the neuronal substrate underlying training related~     improvement and maintenance of motor function in stroke patients. This knowledge would be~     expected to have a substantial positive impact on treatment for stroke patients that will~     significantly improve recovery and would move the field of neurorehabilitation forward.~   "
113574|NCT01569594|"~     The objective of this registry is to capture and assess device performance data from~     subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy~     using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This~     registry provides an ongoing post-market surveillance mechanism to document clinical~     outcomes on the use of the CorMatrix ECM for Carotid Repair.~   "
113575|NCT01569581|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final~     results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit~     vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by~     SFDA in China, Dec. 2010. The phase I clinical and phase II trials were completed, in~     Guangxi Province, China. The results of these clinical trials showed that this vaccine was~     safe and could induce effective antibodies for the infants. The purpose of phase III is to~     evaluate the protected and efficacy of the formalin-inactivated EV71 vaccine in Chinese~     infants and children (from 6 to 71 months old).~   "
113576|NCT01569568|"~     The purpose of this study is to use various types of MRI and cognitive testing to evaluate~     changes in the brain and cognitive function that occur in subjects with ornithine~     transcarbamylase deficiency (OTCD) relative to healthy individuals~   "
113577|NCT01569555|"~     By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician~     would then be able to use this correlation to risk stratify his/her patients for significant~     pathology.~   "
113578|NCT01569542|"~     By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician~     would then be able to use this correlation to risk stratify his/her patients for significant~     pathology.~   "
113579|NCT01569529|"~     The purpose of this study is to determine whether tailored online advertisements will drive~     young adult smoker's (18 to 26 years old), who are motivated to quit, to use Internet-based~     cessation treatment.~   "
113580|NCT01569516|"~     The main purpose of this study is to evaluate the safety and efficacy of~     Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to~     moderate Alzheimer's Disease.~   "
113581|NCT01569503|"~     The purpose of this study is to determine whether (VNS) Vagus Nerve Stimulation , is~     effective in the treatment of Crohn's disease.~   "
113582|NCT01569490|"~     This study is designed to test the hypotheses that incentives can increase both~     participation in smoking cessation treatment and resulting cessation rates, when they are~     offered to Medicaid BadgerCare Plus pregnant smokers.~   "
113583|NCT01569477|"~     This study is designed to test the hypotheses that incentives can increase both~     participation in smoking cessation treatment and resulting cessation rates when they are~     offered to Medicaid BadgerCare Plus members.~   "
113584|NCT01569464|"~     The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS)~     symptoms in subjects with moderate to severe RLS during both day and evening.~   "
113585|NCT01569451|"~     The purpose of this study is (1) to determine if rituximab induction therapy followed by~     glatiramer acetate (GA) is substantially superior to placebo induction followed by GA for~     the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis~     (RMS) and (2) to explore the changes in lymphocyte populations in the CNS as a consequence~     of treatment with rituximab followed by chronic GA therapy.~   "
113588|NCT01569412|"~     Patients with HER2/neu expressing solid tumors progressing after standard therapy will be~     treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this~     trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as~     well as efficacy.~   "
113589|NCT01569399|"~     Prior research in substance dependence has suggested potential anti-craving effects of~     repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral~     prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect~     of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham~     stimulation on craving and alcohol consumption.~   "
113590|NCT01569386|"~     Low intensity physical activity by half squat of the elderly people with hemiplegia~     significantly slow down the pulse wave velocity of the arteries of the lower limbs of the~     paralyzed side within 8 weeks.~   "
113591|NCT01569373|"~     Samples of blood and urine will be analyzed for biomarkers to check their predictivity of~     Graft-versus-Host Disease (GVHD) outcomes.~   "
113592|NCT01569360|"~     Corsets are often used in the management of patients with a spinal cord injury. They may~     help to rigidify the patients' trunk which might help some patients to sit upright; their~     use may also reduce the sensation of dyspnea some patients have while sitting upright. Due~     to spinal cord injury, abdominal muscles are weakened which can contribute to alter the~     respiratory function of the patients. But the corset by rigidifying the abdominal wall can~     improve the efficiency of the respiratory muscles in some patients and reduce dyspnea in the~     sitting position for some patients. However, when patients with spinal cord injury are~     followed over time, one can observe that some patients discontinue corset use. The~     investigators observed that the patients who pursue the corset use still have a significant~     improvement of their respiratory function with the corset while the patients who have~     discontinued the use have improved their respiratory function in the upright position~     (without the corset). As of now, the investigators do not know whether the use of the corset~     is discontinued because of a spontaneous improvement of the respiratory function or whether~     discontinuing the use of the corset may help to develop abdominal spasticity and therefore~     to improve respiratory function. The investigators seek to investigate this issue in order~     to optimize the management of patients who present spinal cord injury.~   "
113593|NCT01569347|"~     The aim of this study is to determine the clinical, genetic and environmental factors~     associated with the phenotype severe psychotic symptoms caused by cocaine.~   "
113594|NCT01569334|"~     Heart transplantation is the best option for patients with end-stage heart failure. Cardiac~     allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation~     and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of~     coronary artery disease (CAD) with similarities to atherosclerosis but also particular~     features of endothelial dysfunction associated to the alloimmune conflict and humoral~     responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method~     for late CAV diagnosis, but occurs lesions are established. Identification of reliable~     non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage~     thus remain a major challenge to optimize therapeutic management of post transplant~     morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from~     a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by~     recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16)~     and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA~     receptors), Natural Killer (NK) cells represent effector cells with unique potential to~     generate both humoral and innate immune injury of graft endothelium.~   "
113595|NCT01569321|"~     Breast cancer is the first cancer in women, the second etiology of death by cancer and the~     first cause for women between 35 and 55 years.~      Diagnostic tools and large screening have been realized with positive impact in a recent~     review with 31% less likely to die of breast cancer over nearly 30 years compared to women~     who didn't get regular screening mammograms. Diagnostic tools and treatment also are~     improving continuously.~      However, for some women, breast cancer diagnosis is difficult, in case of high density~     breast, breast modifications after surgery… In these cases, breast MRI is currently the best~     imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that~     lead to futile biopsies.~      Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify~     cancer treatment.~      However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor~     because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET~     scan for breast, called Positron Emission Mammography. Our project is in this field of view~     and is named CLEARPEMSONIC.~      First clinical studies with PEM showed very good performance of this imaging modality for~     initial evaluation of breast tumors. PEM performance is not affected by breast density,~     hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI,~     adding a better specificity value.~      In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which~     combined PEM scan and ultrasonography.~      Technologic evaluation was made. Now a feasibility study is the first step for clinical~     applications.~      The main objective of this project is to confirm the feasibility of PEM scan with the~     ClearPEmSonic.~      Secondary objectives are to compare results with other conventional imaging modalities and~     MRI.~      The gold standard will be histology of the breast tumor.~   "
113596|NCT01569308|"~     Objective: To determine the value of pulse pressure variation (ΔRESPPP) to predict fluid~     responsiveness in patients ventilated with low tidal volumes (VT), and to investigate~     whether a lower ΔRESPPP cut-off point should be used when patients are ventilated with low~     tidal volumes.~      Methods: This cross-sectional, observational study included 37 critically ill patients with~     acute circulatory failure requiring fluid challenge. They were sedated and mechanically~     ventilated with Tidal Volume (VT) 6-7 ml/kg IBW (ideal body weight), monitored by pulmonary~     artery catheter and arterial line. Mechanical ventilation and hemodynamic parameters,~     including ΔRESPPP, were measured before and after fluid challenge with 1,000 ml crystalloids~     or 500 ml colloids. Fluid responsiveness was defined as an increase of at least 15% in~     cardiac index.~      The present study was designed to (1) determine the value of ΔRESPPP to predict fluid~     responsiveness in patients ventilated with low tidal volumes, and (2) to investigate whether~     a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal~     volumes.~      The study hypothesis is not a good predictor of fluid responsiveness in patients ventilated~     with low tidal volumes.~   "
113597|NCT01569295|"~     This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect~     of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will~     be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib~     or placebo. All subjects will be administered bendamustine and rituximab.~   "
113598|NCT01569282|"~     Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in~     patients planned for curative pancreatic resection in whom peroperative findings makes~     resection impossible.~   "
113600|NCT01569256|"~     Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting~     follicular fluid hormone microenvironmentally altering the follicular fluid levels of~     insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and~     hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian~     hyperstimulation syndrome (OHSS).~   "
113601|NCT01569243|"~     This study is a 2-arm randomized controlled trial examining the effect of personalized text~     messages on physical activity and clinical outcomes in patients with type 2 diabetes~     mellitus.~      The investigators hypothesize that:~      i. The use of personalized text messages will promote physical activity in patients with~     T2DM.~      ii. Increased physical activity and behavior change correlate with better clinical outcomes~     (Change in HbA1c).~      iii. The text messaging program will lead to sustained physical activity behavior change in~     patients with T2DM~   "
113602|NCT01569230|"~     The purpose of this study is to verify the efficacy and safety of acupuncture treatments~     (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).~   "
113603|NCT01569217|"~     The aim of this study is to better discriminate respiratory muscle dysfunction by comparing~     the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the~     conventional tests of respiratory muscle strength. The final objective is to better select~     in the future the patients who need more specific assessment of diaphragmatic function like~     maximal transdiaphragmatic pressure measurement and phrenic nerve stimulation.~   "
113604|NCT01569204|"~     The Purpose of this trial is:~        -  to determine complete response rate (CRR) after six cycles of chemotherapy~        -  to determine complete remission rate (CR/CRr) as final treatment outcome after~          completion of treatment~   "
113605|NCT01569191|"~     Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many~     people, caused by hypersensitivity to normally harmless substances such as pollen, and often~     accompanies seasonal hay fever. Treatments that can be used before initiating medical~     therapy include artificial tear supplements (ATS) and cold compresses (CC). However, there~     is no evidence in the scientific literature that demonstrates their efficacy compared to no~     treatment or their combined effect with anti-allergic medication. Therefore the~     investigators aim to examine the efficacy of ATS and CC alone, in comparison to~     anti-allergic medication, and CC in combination with anti-allergic medication. In addition,~     the investigators also aim to determine the time course of ocular allergic reactions. At the~     end of the study the investigators will be able to see whether or not ATS and CC are~     effective in treating SAC.~   "
113606|NCT01569178|"~     This is a multinational, multicentre, randomised open-label, controlled, parallel-group~     phase III study. Its aim is to demonstrate that a single intracoronary infusion of~     autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in~     patients with reduced left ventricular ejection fraction(</=45%) after successful~     reperfusion for acute myocardial infarction when compared to a control group of patients~     undergoing best medical care.~   "
113607|NCT01569165|"~     The aim of this study was to determine whether rinsing with water or cleansing teeth after~     topical fluoride therapy affect the dental plaque pH.~   "
113608|NCT01569152|"~     The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate~     (MTX) in subjects with active rheumatoid arthritis (RA) despite MTX therapy. The primary~     hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as~     measured by the proportion of subjects who achieve American College of Rheumatology 20 (ACR~     20) response after 12 weeks of treatment.~   "
113609|NCT01569139|"~     Medical information is increasingly processed electronically. This study will describe the~     similarities and differences in the data recorded by different databases of electronic~     healthcare database. These will include the General Practice Research Database (GPRD) and~     the Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics~     (HES).~   "
113610|NCT01569126|"~     The purposes of this study are to look at safety, how well the study drug (LY110140) is~     tolerated, and how much of the study drug gets into the blood stream when given as single~     dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will~     participate in SD portion for approximately 6 weeks and in MD portion for approximately 10~     weeks.~   "
113611|NCT01569113|"~     The purposes of this study are to compare the effects on ovarian activity of quick starting~     a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.~   "
113612|NCT01569100|"~     The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins,~     have recently been demonstrated to improve endothelial function. Additionally, numerous~     studies have shown statins as having antiinflammatory and cell-signaling effects together~     with a selective up-regulation of the eNOS activity. These findings are of potential benefit~     for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed,~     one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of~     eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate~     effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and~     outcome at one year.~   "
113613|NCT01569087|"~     The purpose of the study is to compare safety and efficacy of a single dose of~     empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of~     5 μg/kg/day.~   "
113614|NCT01569074|"~     The purpose of the study is to evaluate the effectiveness of four dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate but not responding. The study will last for 12 weeks.~   "
113615|NCT01569061|"~     The primary objective of this study is to determine the effectiveness of~     transvaginally-delivered low level laser therapy (LLLT) versus Sham in the treatment of~     overactive bladder symptoms in women. The secondary objective is to determine the effect of~     transvaginally-delivered LLLT vs. sham on the quality of life.~   "
113626|NCT01568918|"~     Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a~     large portion of this population which results in increased morbidity as a result of~     increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital~     stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in~     the incidence and duration of postoperative urinary retention and therefore a reduction in~     morbidity related to treatment of urinary retention as well as shortened hospital stays.~   "
113616|NCT01569048|"~     Various maneuvers are commonly used to achieve the ideal operative field necessary for~     successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor~     agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the~     hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral~     vasoconstriction thus it is thus theologically appropriate for reducing bleeding during~     intranasal operation.~      The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor~     agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to~     remifentanil , an ultrashort-acting opioid.~   "
113617|NCT01569035|"~     This study examines using oral anti coagulant warfarin in the management of unexplained~     oligohydramnios improve the perinatal outcome with little or no complications to the mother~     or the neonates.~   "
113618|NCT01569022|"~     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder~     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in~     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and~     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment~     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the~     general population. The proposed study aims at comparing the efficacy, tolerability, and~     adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is~     instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA~     phenotype that would predict oral appliance response~   "
113619|NCT01569009|"~     The primary aim of this study is to examine the physical activity levels of patients with~     bronchiectasis.~      Subsidiary aims are:~        1. To examine whether there is a relationship between the physical activity levels of~          patients with bronchiectasis and clinical phenotype (disease severity, exercise~          capacity, quality of life or other symptoms of their disease). The investigators also~          want to explore the relationship between physical activity levels and readiness to~          change physical activity behaviour (stages of change, self-efficacy, decisional balance~          and processes of change).~        2. To assess the feasibility and acceptability of the physical activity assessment tools:~          ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.~      Hypothesis:~      Patients with bronchiectasis will have low levels of physical activity, and this is related~     to their clinical phenotype (disease severity, exercise capacity, quality of life and other~     symptoms of their disease) and also their readiness to change physical activity behaviour~     (stages of change, self-efficacy, processes of change and decisional balance).~   "
113620|NCT01568996|"~     This is a pilot study to see if oral administration of freeze dried, powdered broccoli~     sprouts have any effect on whether moles end up becoming melanoma.~   "
113621|NCT01568983|"~     The purpose of this study is to investigate the effects of berry juices containing different~     levels of polyphenols on blood pressure and other cardiovascular risk factors.~      The study is a 12 week double blinded randomized controlled intervention trial. The subjects~     will be divided in three groups where one receives a placebo juice while the two other will~     consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will~     be monitored and blood samples will be taken.~   "
113622|NCT01568970|"~     The large number of people on long-term sick leave is a major public health concern in~     Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term~     sick leave causes a decline in individual life-quality, is associated with increased risk~     for mental disorders and represents a very large cost for the Norwegian society.~      The purpose of this study is to determine whether the patients included return to work after~     rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is~     considered to be the effect of Return-to-work rehabilitation measured before, during and~     after the stay at the rehabilitation centre:~      The study specifically looks at the effect of structured and standardized return-to-work~     follow up of the patient, including contact with stakeholders (general practitioner, social~     security office and workplace).~      In addition there is a need to describe the patients participating in the program. The~     aetiology of complex symptom disorders is poorly understood and the role of genetics and~     stress is not translatable to a complex symptom population. This complicates the transition~     from current biological research to a clinical use regarding these patients. If the~     investigators can assist in understanding how these patients, who are multiusers of health~     care and have received sickness benefit for a long time, develop their disorders and~     symptoms, it will be of great importance to the Norwegian community. Therefore the study~     consists of multimodal measurements of the patients before, during and after a~     rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype,~     saliva cortisol, medical-, psychological-, physiological diagnostics and work related~     factors.~      Related aims:~      Investigate if multidisciplinary treatment based on acceptance and commitment therapy,~     contributes to normalisation of cortisol release with regards to a standardized stress test.~      See wether individual differences regarding the stress profile can predict return to work in~     patients with complex symptom disorders.~      Investigate genetic risk factors in relation to Return to Work rehabilitation and identify~     treatment moderators in a multidisciplinary rehabilitation program.~   "
113623|NCT01568957|"~     Community ambulation is a highly complex skill requiring the ability to adapt to increased~     environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking~     may severely compromise the ability to participate fully in community living. Unfortunately,~     current rehabilitation practice for stroke fails to adequately address dual-task~     limitations; individuals with stroke continue to exhibit clinically significant dual-task~     costs on gait at discharge. As a result, many stroke survivors are living in the community~     with residual deficits that may increase disability in the real world and lead to falls with~     devastating consequences. To address this issue, the proposed study investigates the~     efficacy of dual-task gait training on attention allocation and locomotor performance in~     community-dwelling stroke survivors. Because walking in the real world often requires~     time-critical tasks and obstacle avoidance, the investigators will test the impact of~     dual-task gait training on cognitive-motor interference during walking at preferred speed~     and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2).~     The investigators will also evaluate the effects of the intervention on community~     reintegration and participation (Aim 3).~   "
113624|NCT01568944|"~     The investigators hypothesize that blood dendritic cells harbor pathogens from the oral~     cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.~   "
113625|NCT01568931|"~     Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting~     of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of~     myocardial tissue.~      Although the use of thrombus aspiration with PCI can result in improved rates of normal~     epicardial flow and myocardial perfusion, several unmet needs remain.~      Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of~     thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective~     in patients with STEMI.~   "
113627|NCT01568905|"~     Smoking remains a leading cause of preventable disease and premature death worldwide.~     Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half~     of all daily smokers will die prematurely from tobacco-related illness. Reducing the~     nicotine in cigarettes to the point that they are rendered non-addictive can potentially be~     an effective public policy measure that can significantly reduce tobacco-related mortality~     and morbidity by decreasing the initiation of smoking and promoting cessation. The Family~     Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco~     product standards including placing limits on the allowable nicotine content of cigarettes.~     Currently, no reduced nicotine cigarettes are available that will allow studying the~     feasibility of this policy measure. The National Institute on Drug Abuse has contracted with~     Research Triangle Institute to assist in the development of cigarettes with varying nicotine~     content that can be made available to researchers. They have established a contract that~     will result in the manufacture of 9 million cigarettes to be distributed to the research~     community. Prior to full production, the palatability and nicotine intake of these~     cigarettes in smokers must be determined.~   "
113628|NCT01568892|"~     Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-~     controlled, functional monotherapy phase to quantify the antiviral activity attributable to~     dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing~     virological failure on an Integrase inhibitor containing regimen (current RAL or ELV~     failures), with evidence of genotypic resistance to RAL or ELV at study entry. Thirty~     subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B)~     with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to~     dosing with DTG). At Day 8, subjects from both arms will enter an open label phase and~     receive open label DTG 50mg BID with an optimized background regimen containing at least one~     fully active drug.~   "
113629|NCT01568879|"~     The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based~     chronic disease management program compared to patients receiving usual care in achieving a~     target serum uric acid level in patients with recurrent gout.~   "
113630|NCT01568866|"~     The primary objective of this study was to compare progression-free survival in patients~     with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib~     plus dexamethasone or bortezomib plus dexamethasone.~   "
113631|NCT01568853|"~     The role of complement system in bridging innate and adaptive immunity has been confirmed in~     various invasive pathogens. The aim of this study is to investigate the alteration of~     complement C3 in patients with severe abdominal sepsis and evaluate the role of complement~     C3 depletion in prognosis of such patients. The relationship between complement C3 depletion~     and adaptive immunity is studied meanwhile.~   "
113632|NCT01568840|"~     The purpose of this study is to assess the effectiveness of global postural reeducation~     relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.~   "
113633|NCT01568827|"~     Pilot study to determine whether daily consumption of blackraspberry powder (high in~     polyphenols) can reduce markers of inflammation and to determine whether genetics influence~     baseline levels of inflammatory markers as well as individual's response to polyphenols. A~     total of 10 males participated in this cross-over study.~   "
113634|NCT01568814|"~     Morning only low volume PEG with low reside meals may enhance patient tolerability and have~     similar bowel cleansing efficacy compared to standard method using high volume split-dose~     PEG with standard diet.~   "
113635|NCT01568801|"~     This is a RCT studying the effectiveness of the Singapore Program for All Inclusive Care for~     the Elderly (SingaPACE) demonstration project over a 36 month period. SingaPACE is modelled~     on the US PACE home and community based service that acts as an alternative to institutional~     care. The comparator is best referrals for care as currently arranged through the Agency for~     Integrated Care (AIC) and referred by medical social workers. This research aims to~     determine how the SingaPACE model of health and social care affects use of emergency and~     acute care hospital services, institutional care, the quality of life (QOL) and satisfaction~     of the participants aged 60+ and their caregivers.~      The hypotheses to be tested are:~      H01: The elderly in SingaPACE will have fewer admissions to accident & emergency (A&E)~     hospitalization than the elderly who are not in SingaPACE.~      H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than~     the elderly who are not in SingaPACE.~      H03: The elderly in SingaPACE will delay first admission to institutionalized nursing home~     care more than the elderly who are not in SingaPACE.~      H04: The elderly in SingaPACE clients will have a higher QOL compared to the elderly who are~     not in SingaPACE.~      H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to~     caregivers of the elderly who are not in SingaPACE.~   "
113636|NCT01568788|"~     Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May,~     2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza~     vaccine of Hualanbio has obtained production permission and marketing authorization in May,~     2008.~      In order to further investigate the safety and immunogenicity of the vaccine in the market,~     The clinical observation was planned to be conducted in Mianyang city (Yanting County),~     Sichuan Province, China.~   "
113637|NCT01568775|"~     This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy~     subjects and patients with End Stage Renal Disease on hemodialysis.~   "
113638|NCT01568762|"~     This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258~     (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576)~     in patients with well-controlled mild to moderate asthma.~   "
113639|NCT01568749|"~     A study investigating the pharmacokinetic profiles of four extended release paracetamol~     formulations~   "
113663|NCT01568437|"~     Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid~     obesity, which is performed under general anesthesia. TAP block is an analgesic strategy~     covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP~     between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are~     located. As far as the investigators know, this analgesic technique has never been studied~     in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP~     block provides improved analgesia during the first 24 hours after laparoscopic~     gastric-bypass surgery, compared to conventional therapy only.~   "
113640|NCT01568736|"~     The hyper IgD syndrome (HIDS) is an inflammatory disease caused by mevalonate kinase~     deficiency. There is no cure, and available treatments of HIDS febrile episodes have shown~     limited clinical efficacy. The development of effective interventions for HIDS is limited by~     our poor understanding of the disease. The goal of the study is to better characterize the~     inflammatory response during HIDS episodes and to determine the relationship between this~     response and blood and urine markers of mevalonate kinase deficiency. This knowledge will~     help us learn more about the cause of the disease and should lead to the identification of~     new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic~     trials.~      The primary hypothesis is that the costimulatory B7 glycoprotein abnormalities identified in~     the murine MKD model will be recapitulated in sera obtained from human HIDS patients, either~     before, during or after febrile episodes. The secondary hypothesis is that B7 glycoprotein~     molecule levels will correlate with clinical symptomatic severity score, other known~     biomarkers of HIDS, markers of inflammation and or markers of isoprenoid metabolism.~   "
113641|NCT01568723|"~     The purpose of this study is to determine biomarkers which can predict response to ablation~     therapy in patients with Barretts esophagus.~   "
113642|NCT01568710|"~     Background:~      - Many people with sickle cell disease have repeated episodes of severe pain that lasts for~     days, requiring hospital care. These episodes, called pain crises, may be caused by changes~     in blood flow. Researchers want to study blood flow in people with sickle cell disease who~     are having a pain crisis and compare it with their blood flow after the pain crisis has~     resolved. They also want to compare these measurements against blood flow in healthy people~     who do not have sickle cell disease.~      Objectives:~      - To study whether changes in blood flow cause pain crises in people with sickle cell~     disease.~      Eligibility:~        -  Individuals at least 18 years of age who have sickle cell disease and are being treated~          for a pain crisis.~        -  Individuals at least 18 years of age who have sickle cell disease and are not~          experiencing a pain crisis.~        -  Healthy volunteers matched by age and gender with the participants who have sickle cell~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants having a sickle cell pain crisis will have two visits, one during the~          crisis and one about 4 weeks after the crisis has resolved.~        -  Participants not having a sickle cell pain crisis will have one or two study visits.~          Blood samples will be collected during at least one of these visits.~        -  Healthy volunteers will have one or two study visits. Blood samples will be collected~          during at least one of these visits.~        -  During each visit for all participants, cameras and blood flow monitoring equipment~          will be used to measure blood flow in the forearm.~      sickle cell disease.~   "
113643|NCT01568697|"~     Background:~      - Gum disease is a condition in which the tissue around the tooth root becomes swollen and~     infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and~     how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune~     system of an individual handles these bacteria. Researchers want to look at the oral~     bacteria and genetic immune problems of different people to learn how these affect gum~     disease and other conditions of the mouth.~      Objectives:~      - To study how immune system problems may lead to problems in the mouth, including gum~     disease.~      Eligibility:~        -  Children and adults at least 7 years of age who have genetic problems with their immune~          system.~        -  Healthy adults that have periodontal disease~        -  Health adults that do not have periodontal disease~      Design:~        -  This study will involve a screening visit and a study visit.~        -  Participants will be screened with a medical history, blood work and a full oral and~          dental exam, including dental x-rays and photos.~        -  The study visit will involve collection of blood, urine, and other samples, including~          saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy.~          Additional oral and dental exams will be performed. Participants will also answer~          questions about any current medical or dental problems.~   "
113644|NCT01568684|"~     Background:~      - Antidepressants help many people with depression, however, some do not seem to benefit as~     much. Currently, it is not possible to determine who will improve with certain~     antidepressants. Studies have shown that genes may influence whether an antidepressant works~     for an individual. Other studies have shown that depressed people tend to have lower levels~     of a chemical called glutamate in parts of their brain, and that glutamate levels increase~     after recovering from depression. Researchers want to study the antidepressant citalopram~     (Celexa) to see how it affects glutamate levels in the brain. They also want to study how a~     person s genes affect their response to this treatment.~      Objectives:~      - To see whether glutamate levels and certain genes affect how a person responds to a~     particular antidepressant medication.~      Eligibility:~      - Individuals between 25 and 55 years of age who have been diagnosed with major depression~     (without psychotic features). Participants may not have tried more than three antidepressant~     treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          answer questions about mood and current feelings of depression, as well as family~          history of depression. Blood and urine samples will be collected.~        -  This study will have two phases. The first phase may last up to 7 weeks depending on~          current antidepressant use and involves one to seven outpatient visits. The second~          phase lasts 8 weeks and involves five outpatient visits, one every 2 weeks.~        -  In the first phase, participants will stop taking their current antidepressant~          medications for at least 2 weeks before the next phase of the study. Participants who~          are on fluoxetine (Prozac) will need to be off it for 6 weeks.~        -  At the end of this phase, participants will have brain imaging studies to look at brain~          function and chemistry.~        -  In the second phase, participants will take citalopram at the standard dose. They will~          answer questions about mood and response to the medication. They will also provide~          blood and saliva samples for tests.~        -  At the end of this phase, participants will have brain imaging studies to look at brain~          function and chemistry.~   "
113645|NCT01568671|"~     Background:~      - The way that the body burns calories is known as energy expenditure. Some studies show~     that when we are cold, we burn more calories to keep our bodies warm. Brown fat is a special~     kind of fat that can use energy to keep the body warm. Small animals and infants have been~     known to have brown fat for many years. Recently, it has been suggested that adult humans~     also have brown fat. If brown fat becomes active (burns calories) in adult humans when~     exposed to cold, then these people would tend to burn off more calories and might not gain~     weight easily. Learning more about the relationship between energy expenditure, brown fat,~     environmental temperature, and body temperature may help explain why some people become~     obese and other people do not.~      Objectives:~        -  To better understand how the body burns calories when exposed to different~          temperatures.~        -  To study brown fat and how it burns calories in cold temperatures.~      Eligibility:~        -  Healthy men between 18 and 35 or 55 and 75 years of age.~        -  Healthy women between 18 and 35 years of age.~        -  To control for ethnicity, participants must be non-Hispanic whites or African~          Americans.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will stay in the Metabolic Unit of the National Institutes of Health~          Clinical Center as inpatients for no more than 14 days. The length of the hospital stay~          will depend on how participants respond to the different study temperatures.~        -  Every afternoon, participants will walk for 30 minutes on a treadmill. All meals will~          be provided.~        -  Participants will stay up to 5 hours per day in a specialized room with different~          temperature settings. Temperatures will range from about 61 degrees to 88 degrees~          Fahrenheit. Body temperature, activity, calorie burning, and cold/hot sensations will~          be monitored. On the study day of the coldest temperature, participants will have an~          imaging study to look for brown fat activity.~        -  Participants will be compensated for their time and participation at the end of the~          study....~   "
113646|NCT01568658|"~     Background:~      - Some nerve and muscle disorders that start early in life (before age 25), like some forms~     of muscular dystrophy, can run in families. However, the genetic causes of these disorders~     are not known. Also, doctors do not fully understand how symptoms of these disorders change~     over time. Researchers want to learn more about genetic nerve and muscle disorders that~     start in childhood by studying affected people and their family members, as well as healthy~     volunteers.~      Objectives:~      - To better understand nerve and muscle disorders that start early in life and run in~     families.~      Eligibility:~        -  Individuals at least 4 weeks old with childhood-onset muscular and nerve disorders,~          including those who have a later onset of a disorder that typically has childhood~          onset.~        -  Affected and unaffected family members of the individuals with muscular and nerve~          disorders.~        -  Healthy volunteers at least 4 weeks old with no nerve or muscle disorders.~      Design:~        -  Participants will be screened with a physical exam and medical history. Genetic~          information will be collected from blood, saliva, cheek swab, or skin samples. Urine~          samples may also be collected.~        -  Healthy volunteers and unaffected family members will have imaging studies of the~          muscles. These studies will include magnetic resonance imaging (MRI) and ultrasound~          scans. Results will be compared with those from the affected participants.~        -  All participants with nerve and muscle disorders will have multiple tests, including~          the following:~        -  Imaging studies of the muscles, including ultrasound and MRI scans.~        -  Imaging studies of the bones, such as x-rays and DEXA scans.~        -  Heart and lung function tests.~        -  Eye exams.~        -  Nerve and muscle electrical activity tests and biopsies.~        -  Video and photo image collection of affected muscles.~        -  Speech, language, and swallowing evaluation.~        -  Lumbar puncture to collect spinal fluid for study.~        -  Tests of movement, attention, thinking, and coordination.~        -  Participants with nerve and muscle disorders will return to the Clinical Center every~          year. They will repeat the tests and studies at these visits.~   "
113647|NCT01568645|"~     Background:~      - About one-tenth of adults with sickle cell disease have pulmonary hypertension (high blood~     pressure in the lungs). This condition can cause shortness of breath, pain crisis, and~     congestive heart failure. It may even lead to death. Researchers want to test the drugs~     imatinib and carvedilol to see if they can treat high blood pressure in the lungs. Both~     drugs have been used to treat other types of heart problems, but they have not been tested~     as a treatment for high blood pressure related to sickle cell disease.~      Objectives:~      - To see if imatinib and carvedilol are safe and effective treatments for high blood~     pressure in the lungs in adults with sickle cell disease.~      Eligibility:~      - Adults at least 18 years of age who have sickle cell disease and have or may have high~     blood pressure in the lungs.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have different tests of heart and lung function, including a walking test and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants who meet specific criteria will take one of two possible study drugs.~          Those who receive imatinib will take it daily. Those who receive carvedilol will take~          it twice a day.~        -  Participants will have weekly study visits for blood tests and other exams. The study~          drug dose will be adjusted at each weekly visit. It will be increased slowly to reach a~          target dose(based on the participant s weight) or to find a stable effective dose.~        -  Participants may continue to take their study drug for up to 24 weeks, with weekly~          study visits. Regular blood samples and heart and lung function tests will be~          performed.~        -  After 24 weeks, qualified participants may continue to take their study drug for up to~          6 more months. They will have regular study visits to monitor the treatment.~   "
113648|NCT01568632|"~     Background:~      - Imetelstat is a cancer treatment drug that may slow or stop tumor growth. It may also~     prevent tumors from spreading to other parts of the body. Researchers want to see if it can~     be a safe and effective treatment for children who have solid tumors or lymphoma that have~     not responded to other treatments.~      Objectives:~      - To see if imetelstat is a safe and effective treatment for children who have solid tumors~     or lymphoma that have not responded to other treatments.~      Eligibility:~      - Children and adolescents between 1 and 21 years of age who have solid tumors or lymphoma~     that have not responded to other treatments.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants will receive imetelstat on the first and eighth day of a 21-day cycle of~          treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor~          biopsies may also be performed.~        -  Participants will keep taking the study drugs for up to a total of 18 cycles as long as~          the disease does not progress and there are no severe side effects....~   "
113649|NCT01568619|"~     The investigators would like to find out if AESCULON®, a new device that non-invasively and~     continuously measures cardiac output using electrical cardiometry, works as well as one~     existing method--Fick method in patients undergoing cardiopulmonary exercise testing.~   "
113650|NCT01568606|"~     The purpose of this study is to define the safety of using bioimpedance for analysis of body~     composition in heart failure patients with ICD devices. The Biospace America InBody 520~     scale, using direct segmental multifrequency bioimpedance, will be utilized to assess~     patients' fat mass, lean muscle mass, and edema status.~      Although the Biospace America InBody 520 scale is routinely used to analyze body composition~     in various settings including the Ahmanson-UCLA Cardiomyopathy clinic, due to theoretical~     concerns of safety, bioimpedance has not been routinely used in patients with ICDs. The~     investigators hope that this study will allow us to routinely analyze body composition in~     heart failure patients with ICDs, information which can be used to help guide dietary,~     exercise, and medical prescriptions for the investigators heart failure patients.~   "
113651|NCT01568593|"~     Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to~     severe Dry Eye Syndrome~   "
113652|NCT01568580|"~     The purpose of this study is to study the evaluation of efficacy and safety of GreenGene~     (Recombinant Factor VIII).~   "
113653|NCT01568567|"~     Lactobacilli are commensal bacteria common to the gut of all mammals studied and~     traditionally associated with foods are considered safe.The established safe use on a~     diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus~     reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract~     of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants~     as well as adults.~      Although the tolerability of DSM 17938 in a tablet formulation has earlier been established,~     it is desirable to repeat the assessment in this novel formulation.~   "
113654|NCT01568554|"~     The purpose of this study is to test whether a focused questionnaire and laboratory tests~     can better define risk factors associated with possible genetic porphyria. The investigators~     hypothesize that the genetic carrier state of acute porphyria is distinctive enough that the~     Genetic Carrier Profile the investigators devise through this study will be useful in~     identifying carriers of genetic porphyria among the large population with undiagnosed~     abdominal pain.~   "
113655|NCT01568541|"~     There are controversial data about fluoride intake by children when tooth brushing with~     children's or regular toothpastes. However, a study have showed that children were exposed~     to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and~     and regular toothpaste, respectively. Fluorides doses were too close and is questioned if~     there is a real clinical relevance in terms of risk of dental fluorosis. It is important to~     evaluate if children's toothpastes does really represent a risk of fluoride intake when~     compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is~     that both children's and regular toothpastes can represente risks of development of dental~     fluorosis and can represent similar fluoride exposure by children.~   "
114929|NCT01551823|"~     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza~     Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains~     Preservative.~   "
113656|NCT01568528|"~     The focus of the current project is to advance our understanding of the effects of oxytocin~     (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in~     our understanding of the role of OT in rodent models of social behavior and an explosion of~     interest in the prosocial effects of OT in healthy controls, little work has been done to~     dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits~     are a crucial aspect of the functional impairments that limit the rehabilitation of patients~     with SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome,~     Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of~     the illness. Our currently available medications do very little to improve these social~     deficits. Hence it is of utmost public health importance to address the knowledge gap~     regarding the potential of OT to improve social function in this illness. Intact social~     function depends on the competent functioning of several cognitive domains that subserve~     perception of social cues and the generation of motivated social behavior. We propose to~     conduct a pharmacological challenge study of OT vs. placebo administration to study the~     effects of OT on specific components of social cognition in male deficit syndrome SCZ~     subjects.~      Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit~     syndrome SCZ.~   "
113657|NCT01568515|"~     Introduction: Although vaccination against HPV and subsequent HPV-related cancers is a~     significant breakthrough, uptake is low. We sought to understand whether a low-cost~     intervention of electronic (text and/or email) appointment reminders coupled with electronic~     health educational messaging about HPV and the HPV vaccine could increase HPV vaccine uptake~     and knowledge among college students.~      Methods: Study participants included both female and male English speaking students between~     the ages of 18-26 who attended a large university in North Carolina. Students were~     randomized to the intervention or control group. Intervention group participants received~     the electronic messaging while the control group received standard of care at the student~     health center across a 7-month study period. Baseline and follow-up survey data was~     collected. Main outcome measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine~     knowledge. Study recruitment ran from August 2011 to December 2013.~      Results: Completion rates for the intervention and control group were similar for HPV-2 (53%~     vs. 52%) and HPV-3 (34% vs. 32%), respectively. The mean knowledge score at follow-up for~     intervention group participants (n=44, mean knowledge score = 93%, SD = 0.08) was~     significantly higher (p=0.01) than the mean knowledge score at baseline (n=44, mean~     knowledge score = 87%, SD = 0.11). No significant changes in knowledge from baseline to~     follow-up were found for control group participants. The single most important predictor of~     HPV vaccine uptake overall was female gender where female participants were 2.35 times~     [confidence interval (CI) 1.17-4.69] as likely to complete the series as compared to male~     participants.~      Conclusion: In this sample of college students, the electronic messaging intervention~     increased knowledge but not uptake. More randomized controlled trials on the efficacy of HPV~     vaccine electronic reminder interventions for catch-up age populations for both females and~     males are needed.~   "
113658|NCT01568502|"~     Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both~     established non-invasive techniques, used in the clinical routine for the diagnostic~     classification and risk stratification of patients with suspected or known coronary artery~     disease (CAD).~      In this regard, regional wall motion abnormalities (WMA) during dobutamine stress, precede~     the development of ST-segment depression and anginal symptoms, enabling the detection of~     anatomically significant CAD and the assessment of clinical outcomes.~      In a head-to-head comparison between the 2 techniques, favourable diagnostic characteristics~     in terms of higher sensitivity and accuracy were noted for DCMR compared to DSE.~      Although it has been reported that stress induced WMA both in DCMR and in DSE are~     independent predictors for hard cardiac events such as cardiac death or myocardial~     infarction, the value of the 2 techniques for the risk stratification of patients with CAD~     has not been compared to each other so far.~      Comparison of these 2 non-invasive techniques is important, because referring physicians~     need to know which modality is more reliable for the identification of patients at higher~     risk for subsequent cardiac events, who would benefit from early invasive therapy.~      In the investigators study the investigators therefore sought to compare the ability of DSE~     versus DCMR to predict subsequent hard cardiac events and revascularization procedures in a~     patient cohort with high CAD prevalence. Their predictive value was compared to that of~     conventional atherogenic risk factors and to resting WMA. In addition, the investigators~     sought to determine if both techniques are equally suitable for structuring invasive or~     conservative treatment according to the presence or absence of inducible ischemia,~     respectively.~   "
113659|NCT01568489|"~     The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009~     Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).~   "
113660|NCT01568476|"~     Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the~     popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal~     fossa, the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve~     (TN). Studies have shown that when both branches are blocked separately distal to the~     bifurcation site, block onset time is reduced by 30%. Through clinical observation, the~     investigators found that onset time is further shortened when ultrasound-guided SNB is~     performed at the site of bifurcation. This is because the local anesthetic spreads~     interneurally. The purpose of this study is to compare the block onset time of an~     ultrasound-guided sciatic nerve block at the site of nerve bifurcation with the blockade of~     each terminal nerve separately (TN and CPN) distal to sciatic nerve bifurcation.~   "
113661|NCT01568463|"~     Patients experience significant postoperative pain following shoulder surgery, Single shot~     interscalene block is used in ambulatory shoulder surgery for its advantages that include~     significant reduction in acute pain and analgesic requirements, prolonged time to first~     analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The~     process of nerve block requires several needle passes, with each of them being at risk of~     causing nerve injury either by direct trauma or intraneural injection even with the use of~     the ultrasound. These facts raised concerns and several authors stated that maybe the~     anesthesiologists should be more careful, keep a safe distance from the nerve, and inject~     the local anesthetics into fascial planes containing the nerve and not attempt to place the~     needle in close proximity to the nerve. This study is designed to determine the maximal~     effective distance away from the nerve for the injection to be effective.~   "
113662|NCT01568450|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.~      GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.~   "
113664|NCT01568424|"~     The study objective is to gather post-market clinical data on the use of the CentriMag RVAS~     when used for temporary mechanical circulatory support of the right ventricle in patients~     with acute right ventricular failure from any cause~   "
113669|NCT01568359|"~     The purpose of the study is to evaluate the Calcium homeostasis in adult patients with~     uncontrolled acromegaly. The measurements will be repeated 3-6 months after the treatment of~     acromegaly (surgical or medical). The control group consists of patients with nonfunctioning~     pituitary tumors who will undergo surgical removal.~   "
113670|NCT01568346|"~     This study is being done to find out the number of surgical procedures required to achieve~     clear margins in women with newly diagnosed early stage breast carcinoma. The investigators~     are also looking at the number of additional biopsies performed before surgery, the~     mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma),~     time form diagnosis to local therapy, and evaluation time to local recurrence.~   "
113671|NCT01568333|"~     Decitabine has been reported to have a clinically significant, often long lasting effect on~     the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine~     could increase platelet counts by enhancing megakaryocyte maturation and platelet release.~     Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized~     by transient or persistent decrease of the platelet count. However, refractory ITP is~     lacking of effective treatments and the efficacy of decitabine in ITP remains poorly~     understood. Data from this study may provide some idea of decitabine in the treatment of~     ITP.~   "
113672|NCT01568320|"~     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the~     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of~     acute, complicate Type B aortic dissection.~   "
113673|NCT01568307|"~     There is strong evidence that patients with major depressive disorder (MDD) have an~     increased risk of developing coronary heart disease (CHD). This elevated risk is independent~     of standard risk factors such as smoking, obesity, high cholesterol, diabetes, and high~     blood pressure. The relative risk of developing CHD is proportional to the severity of~     depression (the more severe the depression, the more likely the development of CHD).~      The sympathetic nervous system (the part of your nervous system that makes your heart beat~     harder and faster) is responsible for our flight and fight response to a threatening~     situation. It has been determined that increased sympathetic nervous system activation~     occurs in approximately one in three untreated patients with MDD (with no underlying CHD).~     There is growing evidence linking elevated sympathetic activity to early stages of kidney~     dysfunction and an increased incidence of cardiovascular (heart and blood vessel) disease~     development (eg, heart attacks). Sympathetic nervous system activation over a prolonged~     period of time may also be associated with abnormal blood pressure regulation and the~     development of insulin resistance (an important feature of type 2 diabetes).~      It has been suggested that a certain gene, known as the serotonin transporter (5-HTT) gene,~     may be involved. In particular, work from our group indicates that a particular type of this~     gene, the short form (or short allele) may be important in linking MDD, sympathetic~     nervous activation, and increased cardiac risk.~      This study aims to examine the role of the 5-HTT gene on cardiovascular risk factors~     associated with elevated sympathetic activity in patients with MDD. Additionally, the study~     will examine the effect of serotonin re-uptake inhibitor (SSRI) therapy on these parameters.~      A clearer understanding of these systems and processes will allow for identification of~     patients with increased cardiac risk and development of risk reduction strategies. Such~     information is clinically significant given the link between cardiovascular disease and MDD.~      Hypothesis 1: That MDD patients carrying the s allele of the 5-HTT transporter have higher~     sympathetic activity than homozygous ll patients.~      Hypothesis 2: that MDD patients with elevated sympathetic activity display early signs of~     left ventricular hypertrophy (LVH) and diastolic dysfunction.~      Hypothesis 3: That MDD patients with high sympathetic activity have greater morning surges~     in blood pressure than patients with normal sympathetic activity.~      Hypothesis 4: That MDD patients with elevated sympathetic activity display early signs of~     insulin resistance.~      Hypothesis 5: That SSRI therapy, in particular in those who carry the s allele of the 5-HTT,~     has a favourable effect on blood pressure variability and morning surge in blood pressure,~     sympathetic stress reactivity, and markers of insulin resistance.~   "
113674|NCT01568294|"~     The purpose of this study is to determine the tolerated dose of pomalidomide and also to~     evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with~     refractory or relapsed and refractory multiple myeloma.~   "
113675|NCT01568281|"~     This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet~     after a single oral administration of each anastrozole formulation.~   "
113676|NCT01568268|"~     This study was designed to evaluate the treatment efficacy and safety of palonosetron for~     the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general~     anesthesia.~   "
113677|NCT01568255|"~     Statins are a class of drugs that are highly effective at lowering cholesterol levels.~     However, compliance is often limited by symptoms of muscle pain. The investigators would~     like to study Vitamin-D deficient individuals who also have muscle pain due to statin use.~     About 1 billion people are estimated to have low or insufficient levels of vitamin D~     worldwide. Patients with low or insufficient levels of vitamin D may develop muscle disease.~     The purpose of this study is to identify if these symptoms are associated with vitamin D~     deficiency, and most importantly, if treatment of vitamin D deficiency can reduce muscle~     pain that is caused by statin treatment.~   "
113678|NCT01568242|"~     Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen~     during an uneventful phaco surgery. Significant changes occur between the baseline~     temperature and after every step of the surgery.~   "
113679|NCT01568229|"~     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of~     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in~     period on their current antipsychotic treatment, patients will be randomized to one of the~     four treatment arms as add-on therapy for a treatment duration of up to 3 months.~   "
113680|NCT01568216|"~     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of~     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in~     period on their current antipsychotic treatment, patients will be randomized to one of the~     four treatment arms as add-on therapy for a treatment duration of up to 3 months.~   "
113681|NCT01568203|"~     The purpose of this study is to assess the safety and tolerability of AMG 579 following a~     single oral dose administration in healthy subjects (Part A) and in patients with~     schizophrenia or stable schizoaffective disorder (Part B). The study in healthy subjects~     (Part A) concluded, and following a protocol amendment, enrolled only patients with~     schizophrenia or stable schizoaffective disorder (Part B).~   "
113682|NCT01568190|"~     The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite~     mix.~   "
113683|NCT01568177|"~     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in~     heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3~     million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous~     system (ANS) is part of the central nervous system to help people adapt to changes in their~     environment. It controls what are normally involuntary activities, such as heart rate,~     respiration (breathing), body temperature, blood pressure, and urinary function. However,~     there is a limited understanding of the role of ANS in MCD. This research is proposed to~     investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous~     system in women with MCD using mental stress testing, peripheral vascular testing, advanced~     cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited~     in the next five years.~   "
113684|NCT01568164|"~     The purpose of this prospective, single-armed, multi-center clinical trial is to further~     establish the safety and feasibility of using the BioVentrix PliCath HF System for the~     treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from~     heart failure.~   "
113685|NCT01568151|"~     This study is being done to see if teaching physicians and people who are at least 50 years~     old and have not been screened within guidelines for colorectal cancer about the importance~     of colorectal cancer screening will increase screenings for colorectal cancer. The~     researchers want to understand what ways will work best to motivate and educate both~     patients and the doctors and nurses who care for them.~   "
113686|NCT01568138|"~     The purpose of the study is to determine the safety, and feasibility of a device, which~     enables LV volume and radius reduction through scar exclusion in patients whose systolic HF~     is due to ischemic cardiomyopathy.~      Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV~     distribution. Use of this device replicates the geometric reconfiguration of the ventricle~     achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating,~     unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass~     pump (CBP).~   "
113687|NCT01568125|"~     It is well known that incretin, particular GLP-１enhances satiety and reduces energy intake~     in controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.).~     Recently, incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK).~     However, it is not clear how the incretin-based therapy affects energy and content of~     dietary intake in patients with type 2 diabetes mellitus (T2DM). Previously, the~     investigators reported the amount of energy and content of dietary intake in type 2 diabetic~     Japanese patients with more than 10 years of long time duration after discovery using~     questionnaire (Inoue K et al.) and the patients were impaired a secretion of active GLP-1~     (Kamoi et al).~      The investigators examine whether the incretin-based therapy effects on the energy and~     content of dietary intake in the same patients before and one year after administration of~     incretin-related drugs using the same method previously (Inoue K et al.).~   "
113688|NCT01568112|"~     The primary objective of the study is to evaluate whether premedication with 325 mg~     microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the~     incidence and severity of flushing and GI events following oral administration of BG00012~     dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this~     study is to evaluate the safety and tolerability of BG00012 when administered orally as a~     240 mg BID dose regimen with and without 325 mg ASA premedication or following a~     slow-titration dosing schedule in healthy volunteers.~   "
113689|NCT01568099|"~     This is a phase I study to assess the tolerability and safety of 4 injections of two~     different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early~     Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and~     45 years if there is no evidence for genetic forms of the disease and the diagnosis of~     idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in~     Vienna (Austria) will be involved. Each patient's participation will last 1 year.~      In addition, up to 8 patients will be offered participation within an untreated control~     group.~   "
113690|NCT01568086|"~     This is a phase Ib follow-up study to evaluate long-term safety and tolerability of~     immunization with AFFITOPE AD03 applied during AFFiRiS 005A.~   "
113691|NCT01568073|"~     This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with~     entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa~     Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose~     motor fluctuations.~   "
113692|NCT01568060|"~     The purpose of this study is to collect safety information following routine vaccination~     with Infanrix-IPV among infants and children in Korea.~   "
113693|NCT01568047|"~     The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at~     steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated~     with levodopa/dopa-decarboxylase inhibitor.~   "
113694|NCT01568034|"~     The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa~     pharmacokinetics when administered in combination with immediate release levodopa/carbidopa~     or levodopa/benserazide in Parkinson's Disease (PD) patients.~   "
113695|NCT01568021|"~     This multicenter observational study will assess the efficacy and tolerability of OZURDEX®~     in clinical practice, and will assess the time at which patients are considered for~     retreatment.~   "
113696|NCT01568008|"~     This is an observational study in patients with POAG or OHT that will collect data on the~     use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting.~     Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after~     baseline, as per normal clinical practice.~   "
113697|NCT01567995|"~     This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base)~     -controlled, parallel-group study in subjects with moderate to severe eczema (defined by~     investigators global assessment (IGA) score greater than or equal to 3).~      Subjects were screened within 3 days prior to randomization. At the screen visit, subjects~     gave informed consent and were then assessed for health status and eligibility for inclusion~     in the study. At the baseline visit, subject eligibility was assessed for randomization (Day~     0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle~     (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the~     sites in day 7 post-baseline visit for assessment of their disease status and eligibility to~     continue on the study. During the final visit, 14 days after the baseline, subjects returned~     to the study sites for assessment of their disease status before completing the study. In~     addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed~     through the whole trial.~   "
113698|NCT01567982|"~     We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal~     symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.~   "
113796|NCT01566695|"~     Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus~     Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent~     anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk~     myelodysplastic syndromes (MDS).~   "
113699|NCT01567969|"~     The Family Health and Development Project (FHDP) is a randomized controlled trial to~     evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service~     (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically~     disordered children at risk of a psychiatric inpatient admission and their families.~     Children and families are randomized to receive IICAPS or Home-based Child Treatment~     Coordination (Home-based CTC), a home-based case management intervention for coordination of~     mental health services for children. Approximately 144 children and their families will be~     enrolled for a 12 month study period. Data will be collected through interviews with the~     child's parent/legal guardian, and from the child's teacher, the child's school, and the~     Department of Social Services (claims data). This study will test the hypotheses that~     children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less~     likely to experience a psychiatric hospitalization and/or out-of-home placement during and~     up to six months post-discharge from services.~   "
113700|NCT01567956|"~     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine~     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the~     proportion of patients with disease remission at the end of the 8 weeks of treatment. It~     will also aim to investigate capability of the treatment in the maintenance of remission~     after four weeks of treatment interruption; histological changes will be also evaluated and~     finally, improvement in the overall quality of life as measured by the Short Inflammatory~     Bowel Disease Questionnaire (SIBDQ) will be investigated.~   "
113701|NCT01567943|"~     The investigators will evaluate the efficacy of a comprehensive 12-week contingency~     management intervention for treating alcohol dependence for persons with severe mental~     illness who are seen within the context of a community mental health center setting. The~     primary contingency will be submission of alcohol-free urines. Additional reinforcers will~     be provided for intensive outpatient addiction treatment attendance. Reinforcers will be~     vouchers or actual items useful for day-to-day living. Participants will be 120 adults~     diagnosed with alcohol dependance and severe mental illness.~   "
113702|NCT01567930|"~     The purpose of this study is to evaluate the activity of temsirolimus in patients who have~     advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy~     or biologic therapy like sorafenib, but have experienced disease progression or intolerance~     to that therapy.~   "
113703|NCT01567917|"~     Venous thromboembolism (VTE) has harmful effects on morbidity and mortality of cancer~     patients. In Western VTE guidelines, all solid cancer patients receiving abdominal major~     surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such~     as low molecular weight heparin (LMWH) in the perioperative periods. These recommendations~     are based on the high incidence of postoperative VTE development in Western cancer patients.~     However, there have been many cumulative data about the effect of different ethnicity on the~     VTE development and more and more investigators and clinicians admit that Asian ethnicity~     has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to~     apply Western guidelines as it is to the clinical situation of Asian cancer patients.~      Although colorectal cancer (CRC) is one of the common cancers and the incidence is rapidly~     increasing in Asia, there have been few prospective data on the incidence of VTE development~     during the postoperative period in Asian CRC patients. To our knowledge, there have been a~     few small-sized prospective studies in Asia and thus clear conclusions could have not been~     drawn based on those studies. Most Korean colorectal surgeons think that the incidence of~     postoperative VTE development is very rare based on their own clinical experiences. They~     also have much concern about the complications such as bleeding that might be caused by~     routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore,~     in most clinical situation, many Korean colorectal surgeons do not perform perioperative~     pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Asia~     including Korea, the uncritical acceptance of Western guidelines may be inappropriate. The~     necessity of pharmacologic thrombo-prophylaxis can be answered only from our own prospective~     study on the incidence of postoperative VTE development after CRC surgery. Moreover, current~     surgical trend in cancer patients is minimally invasive approach such as laparoscopic~     surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving~     laparoscopic cancer surgery has not been evaluated even in Western countries. Western~     guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really~     necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds,~     this study was designed.~   "
113704|NCT01567904|"~     Primary Objective:~      - To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin~     [AVE5026] (assessed from the anti-Xa activity of Semuloparin) in children in order to~     determine the dose to be assessed in a clinical efficacy/safety study in this population.~      Secondary Objective:~      - To assess the tolerability of Semuloparin when administered at a weight-adjusted, once~     daily dose for up to 30 days in patients less than 18 years of age with central venous line.~   "
113705|NCT01567891|"~     This study, will take a subject's T cells and teach them to be able to recognize and~     attack the ovarian cancer cells. This is done by putting in a gene or genetic material that~     will change how a subject's T cells work and hopefully get them to attack and kill ovarian~     cancer cells. These new T cells are called engineered T cells because the new gene is~     causing them to become directed toward the ovarian cancer cells rather than their usual~     targets. These are also called gene-modified T cells. For subjects who have the HLA A2~     tissue-type marker, the T cells would be engineered to recognize a substance called~     NY-ESO-1. After putting this new gene in T cells (a procedure called gene therapy) the~     investigators will grow the cells in the laboratory and give these cells back to subjects.~   "
113706|NCT01567878|"~     -  Evaluate the correlation of ultrasound MASEI index with clinical, functional,~          radiographic and laboratorial variables in patients with ankylosing spondylitis.~        -  Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound~          (synovitis, erosions, power doppler) with same variables.~        -  Evaluate correlation between articular and enthesis ultrasound exam in this study.~        -  Compare patients and healthy individuals data, to calculate the ROC curve to estimate~          predictor value of disease.~   "
113707|NCT01567865|"~     The proposed JEV05 study is a four-arm double-blind randomized controlled single center~     trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot~     consistency of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP~     facility, and to establish non-inferiority of the new vaccine in comparison to a single lot~     of the same vaccine manufactured in the existing facility. The study will enroll a total of~     1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity~     data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among~     Bangladeshi children. This will be the first step to secure licensure for this life-saving~     vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live~     attenuated SA 14-14-2 vaccine.~   "
113708|NCT01567852|"~     When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter~     using ketamine for induction than using methohexital.~   "
114930|NCT01551810|"~     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza~     Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .~   "
113709|NCT01567839|"~     Infiltration (injecting next to the tooth) injections are common in dentistry and a number~     of studies have shown that articaine anesthetic, when injected next to the tooth as a~     supplemental injection, works very well following a typical inferior alveolar (lower jaw)~     nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine~     with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower~     jaw) infiltration injections of the first molar. The purpose of this prospective,~     randomized, double-blind, crossover study is to compare the degree of anesthesia obtained~     from the three solutions as a primary infiltration injection next to the mandibular first~     molar. The investigators also will record the pain of injection and postoperative pain.~   "
113710|NCT01567826|"~     The study will assess the regression of yellow plaque content of the lipid pool after~     aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin~     10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This~     is a single site study. A total of 100 subjects will randomized, of which 40 will receive~     intensive lipid therapy (Rosuvastatin 40mg) and 40 will receive standard care lipid lowering~     therapy.~   "
113711|NCT01567813|"~     This is a post-licensure safety observation cohort study to describe the general safety of~     GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.~   "
113712|NCT01567800|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer~     using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have~     an effect on how prostate cancer grows and responds to treatments like radiotherapy and~     chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the~     methods used previously.~   "
113713|NCT01567787|"~     The purpose of this study is to determine if Proton Therapy can provide effective and safe~     treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the~     spine.~   "
113714|NCT01567774|"~     Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy~     (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.~      Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment~     with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel.~      Atorvastatin and simvastatin are metabolized by CYP3A4 [Clin pharmacokinetic 2002; 41:~     343-70], whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be~     minimal and principally mediated by the 2C9 isoenzyme, with little involvement of CYP3A4~     [Clin Ther 2003; 25: 2822-5.].~      Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet~     function tests have yielded conflicting results.~   "
113715|NCT01567761|"~     The purpose of this study is to examine whether the intraocular pressure of operated people~     under general anesthesia is affected by the artificial respiration method. If it is proven~     that there is such influence, the findings may lead to select the best method for patients~     with increased intraocular pressure.~      In this study, the investigators will monitor the changes observed in intraocular pressure~     caused during an operation in two different artificial respiration methods:~        1. Intermittent positive pressure ventilation (IPPV)~        2. High frequency jet ventilation (HFJV)~      Study recruited 50 patients aged 18 - 40, candidates to elective orthopedic surgery in the~     limbs. These patients do not suffer from general diseases that restrict their daily~     functioning.~      The selection of the type of surgery was done to prevent the involvement of any other~     factor, except the respiration method, determination of intraocular pressure.~      Exclusion Criteria:~        -  Patients who are unable to provide an Informed Consent~        -  Patients suffering from any eye disease~        -  Patients with corneal thickness less than 450 microns or more than 600 microns~        -  Smokers~        -  Patients with pulmonary disease restrictive or obstructive~        -  Patients using bronchodilator~      All patients operated under general anesthesia using total intravenous anesthesia )TIVA)~     method.~      All patients will be resuscitating half of the time of surgery using IPPV, and in the second~     half of surgery using HFJV.~      During the surgery the IOP will be measured by an ophthalmologist who is unaware of the~     respiration method.~      Correction will be made to the intraocular pressure values, depending on the thickness of~     the cornea.~      The results of the measurements will be collected and the clinical significance will be~     reviewed by acceptable statistical methods.~   "
113716|NCT01567748|"~     Central aortic blood pressure (BP) and flow are generally more informative about the health~     condition of the heart and the arterial system compared with BP measured in peripheral~     locations (e.g. arm or leg). However, their clinical impact has been limited due to the~     cost, risk and discomfort associated with their measurements. Peripheral BP is attractive~     because it can be measured relatively easily than central aortic BP. However, peripheral BP~     is not as useful as central aortic BP since the shape of its waveform is different from that~     of central aortic BP. The applicant recently developed two innovative methods, the~     Individualized Transfer Functions (ITF), which is able to estimate the central aortic BP~     waveform of a patient using the measurements of peripheral BP waveform(s). The methods were~     successfully validated using animal and simulated human subjects. The objective of the~     proposed research project is to examine the validity of these innovative methods in human~     subjects.~      Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion~     healthcare-related cost in Canada every year. The proposed research project will make~     significant contribution in improving clinical care by the potential of ITF in detection and~     diagnostics of cardiovascular disease. In fact, the proposed research project is a key~     initial step towards our long-term research objective of non-invasive cardiovascular disease~     diagnostics. The success of the proposed research project will demonstrate that ITF can~     serve as a low-cost, non-invasive and convenient alternative for central aortic BP~     measurement, which can further be used for the development of detection and diagnostics~     methods for a number of cardiovascular diseases (e.g. aortic valve impairment and peripheral~     arterial disease) by virtue of the relevant health and disease conditions of central and~     peripheral arterial vessels that ITF can deliver.~   "
113717|NCT01567735|"~     The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in~     combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both~     treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4~     infected patients.~   "
113718|NCT01567722|"~     RATIONALE: Collecting and studying tissue samples from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies collecting tissue samples from patients with~     HIV-related malignancies.~   "
113719|NCT01567709|"~     This phase I trial studies the side effects and the best dose of alisertib when given~     together with vorinostat in treating patients with Hodgkin lymphoma, B-cell non-Hodgkin~     lymphoma, or peripheral T-cell lymphoma that has come back. Alisertib and vorinostat may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
113720|NCT01567696|"~     The purpose of this study is to more fully understand the reason(s) that joint replacement~     implants fail and to better identify diagnosis and outcome methods both pre-operatively and~     post-operatively with revision surgery. Analysis of joint replacement failure will include a~     through analysis of laboratory, radiographic, implant, surgical and demographic data.~   "
113721|NCT01567683|"~     This study is designed to assess the tolerability of test product and vehicle in terms of~     skin reactions during repeated topical applications on healthy skin under controlled~     conditions on the basis of the international guidelines for testing of skin irritations (FDA~     Guidance for Industry (1999)).~   "
113722|NCT01567670|"~     The investigators are studying a new treatment for one subtype of obesity. Obesity is not a~     disease. It is a symptom of several different diseases. These diseases have distinct~     etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by~     such non-critical mechanisms might be corrected fairly easily and safely. The investigators~     are interested in overeating and obesity that is caused by the opioidergic system. The~     opioidergic system appears to be responsible for a subtype of obesity associated with binge~     eating disorder (BED). People, especially with the right genetic predisposition, can become~     addicted to foods that release endorphins, in the way that people become addicted to~     exogenous opiates and other drugs that release endorphins. The particular application in our~     proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were~     similar and the bioavailability of naloxone intranasally was 100% (the same) of that~     available IV. IN administration of naloxone has since been broadly tested in humans, as~     well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone~     given by injection .~   "
113723|NCT01567657|"~     The purpose of this study is to determine whether sedation with a combination of pethidin~     hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in~     relation to blood pressure drops during an transesophageal echocardiographic examination~     (TEE).~   "
113724|NCT01567644|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of~     patients with refractory angina not amenable to revascularization with angioplasty or bypass~     surgery.~   "
113725|NCT01567631|"~     The purpose of this research is to compare the classical procedure with intrahepatic~     Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and~     limitations were assessed objectively through our clinical prospective study. The~     investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's~     approach is safe, effective and feasible.~   "
113726|NCT01567618|"~     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly~     docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line~     therapy.~   "
113727|NCT01567605|"~     The main goal of this project is to determine the effects of lidocaine lubricant on~     cardiovascular function during routine bowel care in individuals with spinal cord injury.~     Bowel care is a common trigger of blood pressure and heart rate changes after spinal cord~     injury. In this project, we will be measuring blood pressure and heart rate non-invasively~     during normal bowel routine (which can be performed in the subject's home or at one of the~     investigators facilities). The measurements will occur twice over a period of 28 days: once~     using lidocaine lubricant and once using normal (placebo) lubricant. The recording equipment~     will be attached and subjects will have complete privacy during their bowel routine. The~     trial will be double-blind, meaning that neither the subject or the Nurse Continence Advisor~     who assists with testing will know which lubricant is being used for each test.~      The use of a lubricant gel containing an anesthetic is the standard of care in many hospital~     facilities when performing bowel care for individuals with spinal cord injury; however, it~     is not often used in the home setting. It is thought that using anaesthetic might reduce the~     cardiovascular effects of bowel care after spinal cord injury. However, it is not known~     whether this is the case.~      The investigators hypothesize that the lidocaine lubricant will alleviate some of the blood~     pressure and heart rate changes that occur during bowel care.~   "
113728|NCT01567592|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of~     patients with refractory angina not amenable to revascularization with angioplasty or bypass~     surgery.~   "
113729|NCT01567579|"~     The purpose of this study is to understand how having a heart problem affects~     development,quality of life, and family life in young children and their families. Results~     for children and families with heart disease will be compared to children and families~     without heart disease. The investigators hope that this information may help us to support~     children and families better in the future. All children and families that are seen in the~     HHC Developmental Follow-Up Program will be asked if they would like to take part in this~     study. It is hypothesized that children with congenital heart disease will demonstrate~     developmental delays when compared to normative values.~   "
113730|NCT01567566|"~     The primary objective of this study is to compare the efficacy of two different exercise~     programs for the reduction of pain and disability in a specific subgroup of NSLBP patients~     and aims to investigate the additive effect of hip stabilization exercises. The~     investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer~     program (T2) will be more effective in reducing pain and disability in NSLBP patients~     compared to the local (segmental) stabilizer program (T1).~   "
113731|NCT01567553|"~     While significant progress has been made on medical imagery in recent years in the~     individualization of different lesions in the nervous system for demyelination, axonal loss,~     atrophy, little progress has been made in the specific recognition the inflammatory process.~     Yet this point is essential since the currently available treatments have a partial impact~     mainly on the inflammatory component and that many uncertainties remain about the links~     between inflammation and tissue destruction affecting myelin and axons. The recent discovery~     of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the~     opportunity to answer important questions which one can sense that this could have a~     significant impact on therapeutic drug monitoring of these patients. This study will involve~     50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse)~     from the earliest manifestations of the disease with clinical and MRI scheduled for the~     first 3 years of their disease.~   "
113772|NCT01567007|"~     The purpose of this study is to evaluate the impact of different types of intervention on~     physical activity level and co-morbidities in women workers aged between 40 and 50 years.~     Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to~     participate were randomized to one of the following interventions: GI = Control (n = 47),~     GII = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical~     training set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a~     pedometer), quality of life (SF-36), body composition (BMI, waist circumference and~     bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).~   "
113732|NCT01567540|"~     Hepatitis C infection is a major public health problem with nearly 175 million infected~     individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously~     resolve infection and 40-80% of chronically infected patients (numbers vary depending on~     viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus~     and are sustained virologic responders (SVR). Still for many, the virus manages to~     circumvent natural immunity and current therapeutic strategies, resulting in significant~     morbidity and mortality.~      To better define the distinct clinical outcomes of HCV infection many investigators have~     performed candidate molecules screens or transcriptional profiling in order to identify~     correlates of viral clearance. One molecule that has gained significant attention is CXCL10~     (also known as interferon-gamma induced protein-10 or IP-10) as an important negative~     prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates~     chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is~     counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.~      The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in~     situ, resulting in the generation of an antagonist form of the chemokine. Based on the use~     of specific inhibitors, the investigators now propose to test whether protection of the~     agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy.~     This can be achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal~     truncation of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV~     patients will be tested in future trials that examine potential clearance benefits.~   "
113733|NCT01567527|"~     This will be a randomized, double-blind, placebo-controlled trial to assess the time to~     recurrence of any mood episode in subjects with bipolar I disorder who have maintained~     stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and~     female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder,~     according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric~     Interview (MINI), who have experienced at least one previous manic episode of sufficient~     severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic~     agent in addition to their current manic episode. All subjects must be experiencing a manic~     episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both~     inpatients and outpatients are eligible for this trial.~      This trial will consist of a screening phase followed by 4 treatment phases. Subjects will~     undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy~     phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM~     depot stabilization phase, and, a double-blind, placebo-controlled phase.~   "
113734|NCT01567514|"~     The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on~     risk of pulpal complications in deep occlusal cavities with resin-based restorations.~   "
113735|NCT01567501|"~     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this~     study is to assess the bioequivalence between Test Product and the corresponding Reference~     Product under fed condition in normal, healthy, adult, human subjects.~   "
113736|NCT01567488|"~     The underlying hypothesis of the synergistic activity of octreotide and everolimus is based~     on the combination of a) a direct action of everolimus over mTOR (mammalian target of~     rapamycin), and b) the inhibitory effect of octreotide on the IGF-I (insulin like growth~     factor 1) system preventing the activation of the mTOR system by this factor. Both types of~     inhibition would completely cancel this signal transduction pathway, which is so important~     in neuroendocrine tumours.~      Furthermore, the biological study proposed in this protocol will allow for better~     establishing the relationship between the activation of the IGFR-PI3K-mTOR signal~     transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response;~     this information is relevant since the IGFR-PI3K-mTOR activation status could be a response~     prediction factor.~      This study will provide significant additional information about the efficacy of the~     combination treatment of everolimus with octreotide LAR® in non-functioning GI NET.~   "
113737|NCT01567475|"~     This study is an open label, multicenter study with two phases:~        -  Phase I is a dose escalation study of RAD001 in combination with one injection of~          Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive~          non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum~          tolerated dose (MTD). The purpose of the study is to assess the feasibility of the~          combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug~          interaction (DDI).~        -  Phase II will define the efficacy and safety profile of RAD001 and Rituximab~          combination at the RP2D in patients with lymphomas.~      Patients with lymphomas will be treated at the RP2D established during phase I and evaluated~     for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR)~     and stable disease (SD), and time to progression using the IWG criteria for treatment~     response.~      Induction therapy will follow the same schedule than during the phase I study.~      Maintenance therapy: Monthly cycles for up to 2 years with:~        -  Daily RAD001 at the same dose than during induction therapy.~        -  Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual~          maintenance schedule for Rituximab.~      Response to therapy will be assessed between day 42 and day 49, then every two months.~   "
113738|NCT01567462|"~     The purpose of this study is to compare the uses of two types of equipment during~     transurethral resection of bladder tumors (TURBT). The two types of surgical devices are:~     the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode.~     These two devices do the same task but differ in the way they create electric current when~     removing cancerous tissue. The investigators hope to examine and compare the uses of these~     two surgical devices to see if any advantages do exist or whether they actually are similar.~     The goal of the study will be to prove similarity in outcomes between the two techniques and~     analyze the outcomes resulting from each case.~   "
113739|NCT01567449|"~     The purpose of this study is to examine the risk factors for aneurysm rebleeding.~   "
113740|NCT01567436|"~     Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy~     as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007),~     based on three randomized controlled trials in Kenya, Uganda, and South Africa, that~     reported a protective effect of about 60%~   "
113741|NCT01567423|"~     In the Democratic Republic of Congo (DRC), malaria is an important cause of morbidity and~     mortality. It is estimated that malaria is responsible for 30% of admissions to hospital~     averaged throughout the country and for 25-30% mortality in children under five.~      In 2005, DRC adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial~     treatment. As WHO recommended that the efficacy of antimalarial drugs was monitored~     regularly to avoid an upsurge of mortality and morbidity due to continued use of ineffective~     drugs, a randomized, non-inferiority open-label trial was conducted in Katanga, in order to~     compare the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL),~      Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were~     enrolledand randomly allocated into one of the two regimens. The risk of recurrent~     parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish~     recrudescence from new infection, was analysed.~      Between April 2008 and March 2009, 301 childrenwere included: 156 with ASAQ and 145 with AL.~     No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32~     patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group~     and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI,~     94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference -0.7%,~     one sided 95%CI -3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment~     regimens were generally well tolerated.~      Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of~     uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large~     country such as DRC, and because of possible emergence of resistance from other endemic~     regions, surveillance of efficacy of artemisinin-based combination treatments, including~     other evaluations of the resistance of ASAQ, need to be done in other provinces.~   "
113742|NCT01567410|"~     The purpose of this study is to determine wether e-learning is a more effective than~     traditional classroom teaching at norwegian nurses ability to use the Braden risk assessment~     scale and pressure ulcer classification.~   "
113743|NCT01567397|"~     Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to~     randomised controlled studies.While such studies are essential to determine efficacy and~     safety of the product (usually compared to placebo), they provide no information on the~     effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality~     of life and other patient-related outcomes) in the typical real-life setting under~     clinical practice conditions.Thus, the present study aims to collect data on the~        -  Drug utilization of Microbial Collagenase in the hand of physicians, with focus on~          feasibility, treatment patterns, and effectiveness in clinical practice~        -  Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant~          treatment, follow-up therapy)~        -  Effectiveness (with focus on functionality)~        -  Tolerability~        -  Patient-related outcomes: patient satisfaction, health-related quality of life~        -  Physician satisfaction with therapy~        -  Resource utilization (hospital stays, drug consumption, concomitant medication etc.)~        -  Long-term outcomes~   "
113744|NCT01567384|"~     The purpose of the study is to test the safety of an experimental drug called OSI-906 when~     combined with pemetrexed at different dose levels and to find out the optimal doses of the~     two drugs that can be given as a combination. Pemetrexed has been widely used for treatment~     of certain solid organ tumors and is effective and approved for use in treatment of lung~     cancer and mesothelioma.~   "
113745|NCT01567371|"~     This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid~     monitor) during a period of phlebotomy and graded blood loss in patients who are having~     cardiac surgery.~   "
113746|NCT01567358|"~     The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in~     patients with Rheumatoid Arthritis inadequately treated with Methotrexate.~   "
113747|NCT01567345|"~     The aim of this study is to compare intrathecal morphine administration: using a pump with~     continuous or programmable flow.~   "
113748|NCT01567332|"~     Recovery of neurological deficits after stroke results from a reorganization of cortical~     activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation~     (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of~     neuroplasticity. Its use to improve function after stroke, particularly of the upper limb,~     was validated. The investigators propose to evaluate in a prospective pilot against placebo,~     the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and~     medium term, especially on walking function and spasticity in patients with sequelae of~     cerebral infarction in the MCA territory with gait disturbance and motor weakness of the~     upper limb.~   "
113749|NCT01567319|"~     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. Many factors such as the biovariability, differences in~     extraction process and subsequent handling of allergens can affect the final composition,~     potency, and stability of allergen preparations. Genetic diversity of affected people adds~     another level of complexity. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. Therefore, the system for biological~     standardization mainly used in Europe still is the biological calibration of in-House~     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on~     Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick~     Test (SPT) value. The aim of this procedure is to estimate the biological activity of~     allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the~     extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked~     by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated~     using the same technique (prick testing) on at least 20 individuals who are sensitized to~     the allergen concerned.~      The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium~     perenne, Secale cereale y Olea europaea by using this method.~   "
113750|NCT01567306|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic diseases the aim of this study is~     to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen~     extract subcutaneous vaccine.~   "
113773|NCT01566994|"~     If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine~     Replacement Therapy and Transtheoretical tailored interventions produces an increasing~     treatment trajectory, it will produce unprecedented impacts with unmotivated smokers~     specifically and population cessation generally. These recruitment and intervention~     strategies require limited resources from health care providers and could be readily~     disseminable to other health care systems for application with populations of smokers,~     especially unmotivated smokers who have been understudied and underserved.~   "
113751|NCT01567280|"~     The study design consists of a cross-sectional survey on the clinical characteristics of~     patients with asthma and their level of asthma control and current quality of life, and on a~     prospective evaluation of the rate of switch from the uncontrolled/poorly controlled~     condition to the status of controlled asthma. Asthma control will be based on the Asthma~     Control Questionnaire scoring system, that has been fully validated for use in both clinical~     practice and clinical trials and has strong discriminative properties which means that it~     can detect small differences between patients with different levels of asthma control and it~     is very sensitive to within-patient change in asthma control over time.~      Quality of life as a reflection of the control of the disease, will also be evaluated by~     means of the Mini Asthma Quality of Life Questionnaire scoring system.~   "
113752|NCT01567267|"~     The purpose of this study is to identify the effect of a short term educational intervention~     for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good~     Scientific Practice (GSP) to high-school biology students.~   "
113753|NCT01567254|"~     Background: Pediatric patients with type 1 diabetes mellitus are known to be a challenging~     group for achieving recommended glycemic control. Coping with the demands of self-managing~     IDDM in children and adolescents can be a formidable task, requiring a healthy and balanced~     diet, monitoring and regular insulin injections. Most patients are non-compliant to the~     treatment. A number of controlled studies have examined the efficiency of psychosocial~     interventions for improving compliance and glycemic control among diabetic youth. None has~     examined the effectiveness of guided imagery in treatment of type 1 diabetes mellitus.~      Primary Objective: To asses simultaneously the effect of listening to auditory guided~     imagery and blood glucose variability, compared to variability in blood glucose while~     listening to songs.~      Secondary Objective To assess the effect of routine auditory guided imagery to glycemic~     control and quality of life in children with type 1 diabetes mellitus, compared to listening~     listening to songs.~      Methods:~      Subjects: 14 youth ages 7-16 years with type 1 diabetes mellitus , for at least 6 months,~     and not during the honey moon period will be recruited, and will be blindly randomized to~     receive intervention (auditory guided imagery group) or control (regular auditory music).~      Protocol:~      Design: A randomized Controlled Blinded Study Intervention: 14 randomly numbered CD's will~     be prepared at study initiation, half containing auditory guided imagery and half containing~     music.~      Study protocol: After an initial check up, including HbA1C levels, and explanation of study~     procedures the participants will be given either the intervention or the control CD, to be~     used twice a day for five days. During this period continuous glucose monitoring will be~     performed. On days one and five the procedure will take place while the participants are~     connected to biofeedback. QOL questionnaires will be completed at the beginning of day one,~     or before.~      In the second part of the study the children will use the intervention / control CD at home~     twice a week for 12 weeks. At the end of the study period they will again be evaluated,~     including HbA1C, and all subjects will again complete QOL questionnaires~   "
113754|NCT01567241|"~     Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction~     techniques are required?~   "
113755|NCT01567228|"~     Physician counseling for physical activity, dental services, and academic support services~     such as tutoring could be improved through physician knowledge of local community resources~     and physician counseling directing patients to such services that are near the patient's~     residential address. This study will test the hypothesis that an electronic medical record~     enhanced with geographic information systems can improved physician counseling for physical~     activity, dental services, and academic support services by identifying services that are~     near the patient's residential address and informing MD's of such info at the point of care.~   "
113756|NCT01567215|"~     The investigators want to show that steroid creme and even better alcohol swaps are just as~     effective or equal to the current treatment with silver nitrate of granuloma umbilical in~     newborns.~   "
113757|NCT01567202|"~     This is a Phase II study in a single center to determine the efficacy of autologous~     dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as~     a vaccination in adults with glioblastoma multiforme (primary or secondary).~   "
113758|NCT01567189|"~     The hypothesis is that home based clinical rehabilitation (CR) is less expensive than~     hospital based CR with similar clinical effectiveness. The investigators will compare the~     results of two forms of CR on~        1. direct and indirect healthcare costs~        2. effectiveness on mortality, morbidity, modifiable risk factors control, functional~          capacity measured by exercise testing, health related quality of life and satisfaction~          rate~        3. cost/effectiveness analysis~   "
113759|NCT01567176|"~     This study follows the results of the COMPALICLAMP study (NCT00951392) where the~     investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in~     muscle depending on the quality of aging. The investigators seek to confirm this difference~     in expression level of circulating leukocytes on a larger sample.~   "
113760|NCT01567163|"~     The purpose of this study is to assess the effect of concomitant ramucirumab on the~     pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.~      Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to~     schedule will be replaced for the purpose of analysis; these participants may continue to~     receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles~     1 and 2.~   "
113761|NCT01567150|"~     This study is being conducted to characterize the way leg wounds respond to a new type of~     wound dressing, compared to wounds in patients who are not using the new dressing. The~     investigators will collect wound fluid for biochemical analysis, and they will measure the~     wound healing that occurs with and without the new dressing.~   "
113762|NCT01567137|"~     Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in~     detecting, localising and characterising satellite lesions in relation to an index breast~     tumour in order to improve definition of clinical target volume after local excision.~      Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for~     localising unsuspected multifocal and multicentric lesions in women diagnosed with early~     breast cancer.~   "
113774|NCT01566981|"~     The purpose of the study is to clinically evaluate a new approach to treatment of patients~     with diabetes mellitus type II by using specially developed mobile-internet software~     solution.~      The effect of information and communication technologies (ICT) to improve the integrated~     care of people with diabetes will be identified, developed, introduced and clinically~     evaluated.~      The investigators expect that usage of an e-Health application in health care of patients~     with diabetes mellitus type II could improve the following healthcare outcomes: results of~     the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood~     pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.~   "
114004|NCT01564160|"~     A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna~     canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.~      The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day)~     bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population~     of healthy adult participants.~   "
113763|NCT01567124|"~     The use of antipsychotic medications has increased over the past decade. While more recently~     developed medications are improved with regards to extrapyramidal side effects, the use of~     atypical antipsychotics has been associated with substantial weight gain and a worsening of~     metabolic profile. The time course and extent of weight gain differs among antipsychotics,~     with olanzapine and clozapine being associated with greatest weight gain.~      Mechanisms underlying a worsening metabolic profile, obesity and obesity-related illnesses~     are complex, extending beyond sedentary lifestyle, poor diet and genetic predisposition.~     There is also a growing body of evidence that the sympathetic nervous system (SNS) has a~     role in the generation of both obesity and obesity-related illness. While the role of the~     SNS in blood pressure control is readily acknowledged it is less well appreciated that~     activation of the SNS exerts profound metabolic effects.~      Although the fact of a causal relation linking antipsychotic drugs and obesity is~     unequivocally established, the biological mechanisms operating are unclear, and strategies~     for preventive therapy remain largely unformulated.~      This study aims to investigate the role of the SNS and its association with the metabolic~     abnormalities that are frequently observed in patients with schizophrenia following~     treatment with antipsychotic medications.~      Additionally, the study will investigate whether treatment with the centrally acting~     sympatholytic agent moxonidine will modify SNS activity and, hence, favourably influence the~     downstream metabolic abnormalities seen in antipsychotic treated patients with~     schizophrenia.~      Hypothesis 1: Elevated sympathetic nervous system activity underlies the metabolic~     disturbances observed in patients following antipsychotic therapy.~      Aim 1: To investigate the role of the sympathetic nervous system and its association with~     the metabolic abnormalities that are frequently observed in patients with schizophrenia~     following treatment with antipsychotic medications~      Hypothesis 2: Central sympathoinhibition with moxonidine will blunt the elevated sympathetic~     nervous activity and downstream metabolic abnormalities observed in antipsychotic treated~     patients with schizophrenia.~      Aim 2: Determine whether treatment with the centrally acting sympatholytic agent moxonidine~     will modify sympathetic nervous system activity and, hence, favourably influence the~     downstream metabolic abnormalities seen in antipsychotic treated patients with~     schizophrenia.~   "
113764|NCT01567111|"~     Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of~     secondary hypertension. The diagnosis and targeted treatment of PA is essential because of~     high vascular morbidity associated with PA as compared to essential hypertension with~     comparable blood pressure levels. PA is usually caused by either a unilateral~     aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction~     between APA and BAH is critical since the former may be cured by adrenalectomy, and the~     latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA).~     Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s)~     producing the most of aldosterone excess. The distinction between unilateral and bilateral~     PA can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008~     guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning~     which does not distinguish between aldosterone-producing and common non-functioning adrenal~     nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive,~     dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive~     functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).~      Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary~     objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in~     histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic~     accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial~     remission rates (blood pressure response expressed in Daily Defined Dosages, medical~     therapy, use of potassium supplements) after allocating subjects to MRA-therapy or~     adrenalectomy at 1 and 5 years.~   "
113765|NCT01567098|"~     A randomized trial to study the null hypothesis: single incision appendectomy does not take~     longer operation time when compared to conventional 3-port appendectomy. The study will be~     carried out in a tertiary referral center in Hong Kong with a catchment population of 1~     million.~   "
113766|NCT01567085|"~     Primary Objective:~      To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated~     Rejection (AMR) in sensitized recipients of deceased donor kidney transplants.~   "
113767|NCT01567072|"~     It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing,~     but the knowledge is based only on animal studies, and the results are automatically raised~     for the people.~      Many patients with bone fracture must therefore avoid the formerly so popular and good~     painkillers, although no clinical trial evidence is, that this medicine is really harmful~     for patients with fractures.~      The purpose of this study is to investigate whether these drugs slows bone healing, and what~     the relationship is between various bone studies - DEXA scanning, biochemical bone marker~     tests, radiographic controls and tissue examination of newly formed bone under a microscope.~     How sensitive and specific, each of the above study methods? If they are just as sensitive,~     the cheapest of them recommended as a routine investigation on suspicion of bone effects.~     Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of~     these drugs and their possible harmful side effects (affected and delayed bone healing).~      The expectation is that the study may contribute to increased knowledge about NSAIDs effect~     do pain management, rehabilitation and the entire treatment process significantly easier and~     safer, so that patients recover faster and return to usual activities.~   "
113768|NCT01567059|"~     This study examines a new oral chemotherapy drug called tosedostat, in combination with~     cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of~     amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in~     early studies to have activity against a variety of cancers, including leukemias. Patients~     with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific~     genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after~     treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve~     outcomes for patients that do not respond as well with the current chemotherapy regimens,~     without increasing the risks of treatment.~   "
113769|NCT01567046|"~     This research trial studies genes in tissue samples from younger and adolescent patients~     with soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer~   "
113770|NCT01567033|"~     The purpose of this research study is to evaluate two different Parents as Teachers~     curriculums taught by parent educators, during home visits. The control curriculum includes~     only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons~     plus additional information about how families can live healthy and active lives while~     reaching a healthy weight. The investigators hypothesize the intervention lessons will~     change the way people eat and/or their activity level.~   "
113771|NCT01567020|"~     The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of~     exposure to high-intensity blasts and resulting brain injury. This research team has~     established that recently blast-exposed Soldiers show differences from controls on tests of~     central auditory function. This project will 1) develop a more accurate estimate of the~     prevalence of central auditory dysfunction among Veterans exposed to blasts over the past~     ten years, 2) identify the functional outcomes associated with abnormal performance on tests~     of central processing, and 3) improve understanding of the ways in which blast-exposure~     resembles and differs from both the normal aging process and non-blast-related TBI in terms~     of performance on tests of central auditory processing.~   "
114018|NCT01563978|"~     The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on~     ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a~     disease-modifying anti-rheumatic drug (DMARD).~      The study will last for 57 days.~   "
113775|NCT01566968|"~     The sensitivity of a person's cough reflex can be measured by getting them to breathe in~     (inhale) irritant chemicals. There are different methods by which subjects are asked to~     inhale these chemicals, either by taking one deep breath in, or by asking them to just~     continue to take a number of breaths. The purpose of this clinical research study is to see~     if the coughing responses are different in healthy people and people with respiratory~     problems that make them cough when they are given these chemicals in these two methods.~   "
113776|NCT01566955|"~     The main reason for this trial is to show the feasibility of removing the ovarien and~     fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to~     look for more indications of scarless surgery and we will show that the transgastric~     adnexectomy can be performed in an easy way. It is necessary that there is an indication for~     removing the ovaries and fallopian tubes and if the patient agree we will do it instead of~     through the belly through the gaster and maybe with an additional inzision in the vagina.~     All patients with indication for adnexectomy are potential candidates.~   "
113777|NCT01566942|"~     the aim of this study is to observe the effect of irinotecan-based regimen in patients with~     advanced colorectal cancer.~   "
113778|NCT01566929|"~     The primary aim of the study is to evaluate if weight management intervention for obese~     women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per~     participating woman, as compared to women where no intervention was made.~   "
113779|NCT01566916|"~     This prospective, randomized study will study the 2 year survivorship and short term~     outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using~     two surgical approaches. The surgical approaches being studied are direct anterior and~     anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will~     be compared. Subjects will be randomized to surgical approach and followed for a period of~     two years.~   "
113780|NCT01566903|"~     MR angiography (MRA) has become essential in the treatment of neurovascular diseases,~     including ischemic stroke - the first cause of disability in occidental countries, vascular~     malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments~     are improving year after year.~      MRA is an alternative to digital substracted angiography (DSA), circumventing th use of~     endovascular catheterism, irradiation and injection of iodinated contrast agent.~     Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard~     for vascular MR exploration but still presents many limitations inherent to the injection of~     contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection~     limits the improvement of spatial and temporal resolutions and requires an accurate~     synchronization of the acquisition with the arrival of the bolus.~      Moreover, the acquisition can be repeated as required as it does not require any contrast~     injection.~      Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be~     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has~     restricted the use of CE-MRA. More than 500 cases were described to date in the world.~      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal~     insufficiency and its mortality around 30 %.~      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent~     (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST~     *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30~     ml/mn.~      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide~     complete and non-invasive investigation of the vasculature, thus offering patients with~     chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side~     effects.~      Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio.~     Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can~     achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms~     close to those of cerebral DSA.~      These sequences allow a joint hemodynamical and morphological assessment of lesions, both at~     the cervical and cerebral levels, whether at diagnosis or during patient follow-up~   "
113781|NCT01566890|"~     Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to~     change their shape from a round shape to a half-moon/crescent or sickled shape.~     Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood~     flow, and can cause inflammation and injury to important body parts. There are no specific~     treatments that improve this condition and promote blood flow hindered by sickle cell~     blockages. Another big challenge in managing sickle cell disease is that there are no good~     measures to determine changes and improvements in blood flow.~      Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the~     heart, muscles, and other organs. It is extremely sensitive and can detect blood flow in the~     smallest of blood vessels. It would be very useful in helping healthcare providers know~     whether treatment strategies are improving blood flow during sickle cell blockages.~      The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining~     changes in blood flow of subjects with sickle cell disease.~   "
113782|NCT01566877|"~     The purpose of this study is to evaluate the safety and tolerability of healthy male and~     female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in~     and to evaluate the pharmacokinetics (PK).~   "
113783|NCT01566864|"~     The investigators have designed a three-part quality improvement intervention to 1) improve~     the clinic-based measurement of blood pressure, 2) introduce a care management system to~     promote self-management behaviors and rapidly titrate medications by algorithms developed in~     accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider~     education system that promotes patient-centered care and provides practical examples of~     patient-provider communication strategies. The intervention will occur at six clinics within~     the metropolitan area of Baltimore, Maryland. The investigators will also describe clinic~     and health system characteristics and measure their association with implementation~     (uptake), success (improvements in blood pressure control and reductions in racial~     disparities), and sustainability of the three-part intervention over 12 -24 months.~   "
113794|NCT01566721|"~     This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and~     tolerability of assisted- and self-administered subcutaneous Herceptin (trastuzumab) as~     adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been~     excised. Patients will receive Herceptin 600 mg subcutaneously every 3 weeks for 18 cycles,~     either by an assisted administration using a conventional syringe and needle (vial~     formulation, Cohort A) or with assisted- and self-administration using a single-use~     injection device (SID) in selected patients (Cohort B). Anticipated time on study treatment~     is up to 1 year.~   "
113795|NCT01566708|"~     To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute~     tinnitus drug treatments are only rated as being successful in approximately half of all~     cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic~     approach (the Heidelberg Model of Music Therapy) as a new treatment option for patients~     with recent onset tinnitus after initial medical treatment has failed.~   "
113784|NCT01566851|"~     Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis~     (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for~     cardiovascular risk management in patients with rheumatoid arthritis, including a~     cardiovascular risk assessment annually.~      The goal of this study is to evaluate the application of EULAR recommendations in real life~     in patients with RA in the french population. Inclusion criteria: all patients over 18 years~     old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy,~     affiliated to the RSI (regime social des independents which correspond to other branches of~     the universal healthcare insurance agency). Non inclusion criteria: patients declared as~     rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The~     following analysis will be performed on the whole database of the RSI, without name~     identification. Evaluation criteria: at least once a years the prescription of at least one~     of the following items use in the evaluation of the cardiovascular risk factors: lipides~     dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs~     arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This~     evaluation will be done on the whole national population of RSI for the year 2011~     (01/01/2011 - 31/12/2011). On a subgroup of patients from the region Provence Alpes Côte~     d'Azur, the investigators will analyze the year 2009, and compare to year 2011, to evaluate~     the impact of theses recommendations.~   "
113785|NCT01566838|"~     Rationale: For the past 3 years the investigators have routinely used an axial subpleural~     tunneling technique that del~      Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure~     performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be~     screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery,~     need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or~     hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic~     ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary~     disease (COPD), inability to consent, or are pregnant. All patients included will be~     screened, consented, and operated on by the one year anniversary of institutional review~     board (IRB) approval.~      Study Methodology: Eighty-six consented patients will be randomized into the study arm (use~     of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain~     catheter). The primary outcome is the use of narcotic pain medication post-operatively,~     compared between study groups. Secondary outcomes will include postoperative pain scores,~     hospital and length of stay.~      The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere,~     creating a functional multi level rib block. Despite positive subjective results, objective~     data is lacking. The investigators have also noted that some patients develop an annoying~     short term paresthesia that has been minimized by using lower anesthetic concentrations than~     described in other publications.~      Objectives: To evaluate visual analog pain scores post-operatively up to 30 days~     post-operative, and to determine any association between pain management and length of stay.~      Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology:~     Total amount of narcotic pain medication administered through postoperative day 7, will be~     compared between the study groups using student's t-tests and Wilcoxon rank-sum tests.~     Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30~     post-operatively, hospital length of stay, and overall hospital cost, will also be compared~     among study groups using student's t-tests and Wilcoxon rank-sum tests.~   "
113786|NCT01566825|"~     The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep~     dependent consolidation of procedural memory (visual discrimination task,~     Karni-Sagi-paradigm).~   "
113787|NCT01566812|"~     This study aims to find out whether breast feeding optimization will increase breast feeding~     rates and to evaluate its effect on cardiovascular risk and general health of children.~   "
113788|NCT01566799|"~     Background Obesity and overweight are well known risk factors for breast cancer and also are~     associated with higher recurrence and mortality rates.~      Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms~     of pathologic complete response in comparison with placebo plus the same chemotherapy~     regimen Design: Randomized, double blind, clinical trial. This study will be performed at~     National Cancer Institute of Mexico City, at breast cancer unit.~      Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.~      After completion of chemotherapy all patients will have a breast surgery to assess~     pathologic response.~      Complete pathologic response is defined as the abscence of malignant cells in breast tissue~     and lymph nodes. The presence of DCIS is considered as pCR~   "
113789|NCT01566786|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate~     the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®)~     in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).~   "
113790|NCT01566773|"~     The overall objective of this study is to determine an optimal dose and dosing regimen of~     PT001 MDI for further evaluation in later stage studies.~   "
113791|NCT01566760|"~     This is an open-label (both the physician and healthy volunteer know which medication will~     be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics~     (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by~     the body) and the effects of food on the pharmacokinetics of the drug. This study will take~     place over approximately 8 weeks and will consist of a screening visit to determine~     eligibility for the study, and 2- or 3-period treatment phase for each cohort.~   "
113792|NCT01566747|"~     This is a phase II open label, single arm study evaluating treatment with pazopanib post~     sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will~     receive 800mg pazopanib per day given continuously until disease progression. Patients must~     have received treatment with sunitinib and relapsed. Patient must have received prior~     treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or~     everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage~     design with an interim analysis planned after the first 15 evaluable patients. If 8 or more~     of the first 15 evaluable patients remains disease free at 4 months, then a further 28~     patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is~     estimated that there could be up to 10% of patients dropping out and so to achieve the~     required number of 43 evaluable patients the study will recruit up to 48 patients to ensure~     that 43 complete if stage 2 is required.~      Patients will receive treatment until disease progression, unacceptable toxicity or~     withdrawal of patient consent. Response assessments will be carried out every 8 weeks until~     disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for~     liver function tests after 2 weeks) for the first six months and then every eight weeks~     until disease progression. A further safety assessment will be carried out 4 weeks after~     treatment discontinuation.~   "
113793|NCT01566734|"~     This study conducted to assess the effects of normal saline or cefazolin irrigation on the~     incidence of SSIs.~      Hypothesis:~      Normal saline or cefazolin irrigation decreases the incidence of SSIs.~   "
113797|NCT01566682|"~     The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy~     in the risk stratification of patients with pulmonary lesions identified by CT that are~     suspicious for lung cancer. A statistically significant result will indicate that patients~     with a high ProLung Test result have a greater risk of developing lung cancer than patients~     with a low test result.~      There are three Specific Aims of this study:~        1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in~          patients with a diagnosis.~        2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by~          comparing the test result to the conclusive patient diagnosis.~        3. Assess the safety and tolerability of the ProLung Test procedures.~      Study Design This Study consists of two distinct phases, Stabilization and Validation. The~     Study will collect data from multiple sites (3 to 12), and each site may enroll patients and~     collect data for the Stabilization and Validation Phases with a minimum of three sites for~     the Validation Phase.~   "
113798|NCT01566669|"~     The purpose of this study is to determine the effects of parecoxib in combination with~     epidural morphine in providing analgesia for patients undergoing gynecological surgery.~   "
113799|NCT01566656|"~     Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to~     reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities~     associated with the transplant. Consequently non-relapse mortality has been reduced,~     including in elderly patients with comorbidities. However, despite this benefit in terms of~     toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the~     initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal~     and viral infections are always serious complications. The aim of our study is to check if a~     new modality of reduced intensity preparative regimen combining total lymphoid irradiation~     (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the~     incidence of acute GVHD after allogeneic transplantation while preserving the antitumor~     benefit.~   "
113800|NCT01566643|"~     This prospective controlled randomized open-label clinical trial is designed to determine~     the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies~     for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will~     receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole +~     amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin +~     clarithromycin + metronidazole.~   "
113801|NCT01566630|"~     This study is designed in two parts. Part 1 will assess the safety and tolerability of~     different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood~     pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can~     prolong pregnancy in women with pre-eclampsia.~   "
113802|NCT01566617|"~     The investigators hypothesize that pharmaceutical care may constitute an important tool for~     the clinical management of these patients by improving their compliance to their treatment~     with consequent improvement in their quality of life by minimizing symptoms, and decreasing~     the number of hospital admissions and adverse drug reactions. Therefore, the aim of this~     trial is to evaluate the contribution of pharmaceutical care to clinical treatment of~     patients with Chagas heart disease complicated by heart failure.~      Study Type: Interventional~      Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1)~     group who will receive standard care and pharmaceutical care; and (2) group who will receive~     only standard care. Both groups will be subjected to a follow-up period of 12 months. The~     primary outcome of this trial is the evaluation of quality of life, measured by the 36-item~     short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes~     include drug-related problems and exercise tolerance measured by the standard six-minute~     walk test.~   "
113803|NCT01566604|"~     This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237~     in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks~     treatment.~   "
113804|NCT01566591|"~     The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS~     in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully~     treated with antidepressant medications.~   "
113805|NCT01566578|"~     Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.~   "
113806|NCT01566565|"~     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with~     the primary objective of testing the safety and tolerability of combined oral doses of~     theophylline and bambuterol in healthy human subjects. The secondary objective is to assess~     the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in~     combination. It is hypothesized that the combination of these drugs is generally safe, and~     that no drug interaction can be observed.~   "
113807|NCT01566552|"~     The study is designed to determine the use of delivering point of care, rapid diagnosis with~     rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary~     Health Center (PHC) settings with regard to operational feasibility, safety and final cure~     rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the~     PHC level would bring the best available interventions closer to the patients with visceral~     leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would~     support the VL elimination program in the Indian subcontinent.~   "
113831|NCT01566240|"~     Chemoradiation has been the standard treatment for advanced cervical cancer for a decade,~     but one third of women still die from a failure to control systemic disease. In a recent~     multicentre phase II trial of 46 women the investigators found that, 68% of women had~     tumours that responded to weekly induction chemotherapy prior to chemoradiation. The~     induction chemotherapy had acceptable toxicity and did not compromise the standard~     chemoradiation treatment. In addition, the overall survival and progression free survival at~     3 years was 66% (95% CI 4779). These results, together with acceptable toxicity, provide~     justification for evaluating induction chemotherapy prior to chemoradiation in a randomised~     phase III trial. The investigators aim to investigate in a randomised trial whether~     additional induction chemotherapy given on a weekly schedule immediately before standard~     chemoradiation leads to an improvement in overall survival. The investigators plan to~     recruit 770 women with locally advanced cervical cancer who are eligible for standard~     chemoradiation, they will be randomised to weekly carboplatin and paclitaxel chemotherapy~     for 6 weeks followed by chemoradiation or to chemoradiation alone. The trial will recruit~     for 4 years with 5 years of follow up period.~   "
113808|NCT01566539|"~     The overall objective of this project is to explore the biological bases of individual~     variation in cooperative social behavior among normal subjects, with the goal of developing~     hypotheses to explain more extreme variation that manifests as mental illness. Cooperative~     behavior will be measured in an interactive social task known as the Prisoner's Dilemma (PD)~     Game. There are eight specific aims. Aim 1 is to examine the relationship between individual~     variation in cooperative behavior and individual variation in brain function during the PD~     game. This will be accomplished by imaging subjects' brains with functional Magnetic~     Resonance Imaging (fMRI) as they play many rounds of the PD Game with two assumed human~     partners. Aim 2 is to examine the relationship between individual variation in cooperative~     behavior and individual variation in prefrontal cortex anatomy. This aim will involve~     acquiring a structural Magnetic Resonance Imaging (MRI) scan from each subject to measure~     morphometric variation, as well as a diffusion tensor imaging (DTI) brain scan to measure~     white matter integrity. Aim 3 is to investigate the impact of intranasal oxytocin (OT) and~     vasopressin (AVP), neuropeptides associated with social bonding, on cooperative behavior and~     associated brain activity. In this placebo-controlled, double-blind experiment, subjects~     will be randomized to one of three conditions: intranasal oxytocin (OT) administration,~     intranasal vasopressin (AVP) administration, or intranasal placebo administration.~     Functional brain activity and behavior will be compared across treatment groups. Aim 4 is to~     examine the effect of oxytocin (OT) and vasopressin (AVP) on cortisol levels. Aim 5 is to~     examine the relationship between individual variation in cooperative behavior and individual~     genetic variation. Saliva samples will be collected from each subject for analysis of genes~     hypothesized to have an influence on cooperative social behavior. Aim 6 is to examine the~     relationship between individual variation in cooperative behavior and individual variation~     in personality, as assessed by personality tests. Aim 7 is to examine the relationship~     between individual variation in social intelligence and individual variation in brain~     anatomy. Aim 8 is to use functional Magnetic Resonance Imaging (fMRI) to test the effect of~     vasopressin (AVP) on neural responses to faces, which are powerful social signals important~     for emotional communication. Aim 9 is to use fMRI to investigate the brain regions active~     during an empathy and perspective-taking task. Aim 10 involves testing the effect of OT on~     both empathy-related behavior and functional brain activation, using a within-subjects~     placebo-controlled design. Aim 11 investigates the role of early life experience,~     spirituality, self-reported prosocial activities, and general cognition on empathic and~     cooperative behavior. Aim 12 is to examine the neural and behavioral effect of Lorazepam~     used as a challenge agent in the context of iterated PD game in healthy controls. Aim 13 is~     to examine the effect of OT on behavior and brain activity of unmedicated depressed or~     anxious men in the context of the iterated PD game. Aim 14 is to determine if DNA~     methylation of the oxytocin receptor gene (OXTR) modulates the effect of intranasal OT on~     cooperative behavior and associated brain activity in humans subjects immersed in genuine~     social interactions.~   "
113809|NCT01566526|"~     The purpose of this study is to use retrospective data to evaluate the efficacy, safety and~     re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein~     occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs~     Program.~   "
113810|NCT01566513|"~     The current study, through a randomized controlled design, will evaluate the effectiveness~     of peer support, as compared to usual care and to an equivalent amount of support offered by~     peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions~     and in promoting recovery and community inclusion among adults with mental illnesses with~     histories of multiple hospitalizations. The current study evaluates the cost-effectiveness~     of adding peer support to the array of services available to persons with serious mental~     illnesses who have histories of multiple hospitalizations and will test a theoretical model~     of the active ingredients of peer support, focusing specifically on the roles of 1)~     instillation of hope through positive self-disclosure; 2) role modeling of self-care and~     exploring new ways of using experiential knowledge; and 3) a trusting relationship~     characterized by acceptance, understanding, and empathy with conditional regard.~   "
113811|NCT01566500|"~     There is an urgent need to understand the psychological and situational factors that~     influence medication adherence in individuals with epilepsy. According to the Center for~     Disease Control (CDC, 2010) about 2.5 million people in the United States have epilepsy and~     one third of them still have seizures despite receiving treatment. With proper medication,~     an estimated 60-70% of individuals with new onset epilepsy become, and remain, seizure free~     (Kwan & Brodie, 2000). Despite the success of medical treatment of epilepsy, many patients~     do not receive these benefits due to inadequate adherence to medication (Meyer et al.,~     2010). And, as with other chronic medical conditions, estimates suggest that between 30% and~     60% of patients with epilepsy are not adherent with their drug regimens (Green & Simons~     Morton, 1988; Leppik, 1990; Jones et al., 2006). Poor adherence may be the most important~     cause of poorly controlled epilepsy (Gomes et al., 1998). Stanaway et al. (1985) found that~     31% of seizures were precipitated by nonadherence to medication.~      Questions regarding adherence are theoretically informed by Fisher et al. (2006)'s~     Information Motivation Behavioral Skills (IMB) model. While originally developed to~     describe, predict, and inform interventions for antiretroviral treatment for human~     immunodeficiency virus (HIV), this study applies the model to epilepsy for the first time.~     In addition, this study intends to produce an accurate description of how individuals with~     epilepsy manage their medication adherence by identifying current self regulation strategies~     (immediate adherence behaviors, preparatory behaviors, and barrier management strategies)~     and their situational determinants. Situational determinants can explain some of the~     fluctuations in medication adherence. Patients who are motivated to take their medications~     might still show inconsistent medication adherence. For example, patients might miss good~     opportunities to take their medication or fail to anticipate unexpected barriers such as a~     spontaneous dinner with friends or a bout of depression. Therefore, the study will take~     particular care to investigate situational cues such as good opportunities for adherence~     (e.g., taking medication with regular meals or before brushing teeth) and expected and~     unexpected barriers. Preparatory behaviors and their cues are also of interest in this~     study: Some patients use facilitators (such as physical or electronic reminder systems,~     electronic pill bottles and pill boxes) to ensure adequate medication adherence. Social~     support can serve a similar function of reminding patients to take their medication. To~     address these questions, the investigators plan to explore how individual regulation and~     social support influence medication adherence in patients with epilepsy. The specific aims~     of the proposed research are:~        1. To test the hypothesis that there will be a main effect of information, motivation and~          behavioral skills, on adherence behavior, and that a mediation model will show that~          information and motivation effects are partially mediated through behavioral skills.~        2. To identify self regulation strategies and their situational cues (good opportunities,~          facilitators, and barriers) for medication adherence among individuals with epilepsy to~          better describe best practices and challenges.~   "
113812|NCT01566487|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,~     crossover, multicentric experimental bioequivalence study.~   "
113813|NCT01566474|"~     The study consists on determining whether melatonin decreases oxidative stress in Barrett's~     esophageal mucosa after 6 months of treatment. In order to achieve the clinical trial, the~     patients will be randomized to two possible arms: omeprazole alone or omeprazole plus~     melatonin. The patients will be followed around four visits during six months.~      GERD is one of the most prevalent pathologies in the digestive tract. Barrett's esophagus, a~     complication of chronic GERD, has attracted the attention of researchers due to its~     condition of pre-neoplastic lesion. At present, treatment of Barrett's patients is limited~     to acid inhibition with PPIs. Although there are several studies which indicate that~     treatment with PPIs could decrease the incidence of high grade dysplasia and EAC, treatment~     with PPIs does not eliminate the risk of EAC in these patients. Therefore, it is necessary~     to find chemo-preventive agents that stop neoplastic progression of Barrett's esophagus.~     Among them, antioxidants have become the most promising agent. This pilot study will~     determine the efficacy of melatonin in the chemoprevention of EAC.~      So, the main objective of this study is to determine whether melatonin decreases oxidative~     stress in Barrett's esophageal mucosa after 6 months of treatment.~      To evaluate whether melatonin modifies other mechanisms associated to neoplastic progression~     in BE patients: proliferation and apoptotic index and molecular markers of progression:~     17pLOH, 9pLOH, p16 methylation and DNA ploidy (tetraploidy and/or aneuploidy).~   "
113814|NCT01566461|"~     The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral~     drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral~     arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.~   "
113815|NCT01566448|"~     Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect~     when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about~     40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation~     therapy of the head and neck, and up to 100% of patients undergoing a bone marrow~     transplant. Because the pain from mucositis can be so bad it can cause the inability to eat~     or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer~     treatment because patients may have to be given a lower dose of a drug or stop treatment~     completely. There are not many treatments today that can help relieve the severe pain caused~     from mucositis. This research study will help researchers determine if using an oral~     mouthwash called Ketamine will help lessen mucositis pain.~      Ketamine is approved by the Food and Drug Administration (FDA) for use with general~     anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a~     standard treatment option for mucositis pain.~      During this study patients will be assessed to determine the level of pain caused by their~     mucositis. This will occur before the first dose, one hour after the first dose, and then~     daily until they are no longer on the study. Patients will use the mouthwash by swishing and~     spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will~     use the mouthwash on this study until their mucositis gets better or until the mucositis~     gets worse (or if the pain does not get better after three days of treatment).~   "
113816|NCT01566435|"~     This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF)~     consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel),~     cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with~     stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to~     reduce or downgrade locally aggressive tumors, and improve the chance of eradication by~     chemoradiation.~   "
113817|NCT01566422|"~     Despite the use of prophylactic systemic antibiotics and improved surgical technique,~     surgical site infections remain a serious concern. The incidence of deep infection after~     spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for~     traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of~     treating such infections is profound. With diminishing healthcare dollars and policy that~     refuses to reimburse for postoperative infections, it is critical that physicians and~     hospital systems seek out cost effective ways of decreasing postoperative infections. Local~     delivery of antibiotics into the surgical site have been found to significantly decrease~     infection rates in those undergoing posterior spine fusion for traumatic injuries as studied~     in a retrospective manner by the investigators of this grant. In this proposal the~     investigators will prospectively randomize patients undergoing posterior spinal~     stabilization for traumatic injuries into either receiving vancomycin powder into the~     surgical site (treatment) versus not receiving vancomycin powder (control) and subsequently~     follow infection rate, complications, and cost of care. The investigator's hypothesis is~     that i) vancomycin powder will decrease infection rates ii) have no systemic toxicity iii)~     and be a cost saving advancement in the safety of delivering spine surgical care.~   "
113818|NCT01566409|"~     Constipation is a common problem among children. The majority of children suffering from~     constipation have no underlying disease. Although constipation has no basis in underlying~     disease, it often leads to a reduced quality of life of children who are on par with or~     worse than for children suffering from serious diseases such as cardiovascular and rheumatic~     diseases.~      Despite the high frequency of constipation among children, little is known about the causes~     and treatment of constipation.~      Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol~     junior has proven very effective and are therefore widely used in children as disimpaction~     and maintenance treatment. There is currently no research to prove the need for and length~     of maintenance treatment with laxative medications in children.~      The purpose is to examining the effectiveness of maintenance treatment with Movicol.~     Additional til study will examine how the anal diameter change during a course of treatment~     and the degree to which it can be used as an indicator of treatment efficacy.~      The study will test the following:~      • What is the effect of maintenance treatment with PEG compared to placebo?~      The results from this study are expected to form the basis for an evidence-based approach to~     the use of maintenance therapy and the use of ultrasound of the rectum in children with~     constipation.~   "
113819|NCT01566396|"~     The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation~     and resurfacing of the skin, and for the treatment of facial wrinkles. This study was~     designed in order to evaluate the safety and efficacy of the A3F for treatment of facial~     wrinkles.~   "
113820|NCT01566383|"~     The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between~     ages, gender, race and different values of body mass index (BMI). This fact can cause new~     modifications in the normal values such as making new scales for different age groups or BMI~     groups.~      Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never~     experienced reflux related symptoms and are in between the same ranges of age and BMI of our~     gastroesophageal reflux disease (GERD) patient population.~   "
113821|NCT01566370|"~     This is a randomized, double blind, placebo controlled trial of the medication zonisamide~     for the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms,~     in bipolar subjects that drink excessively and heavily.~      Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in:~        1. significant reduction in heavy drinking days, drinks per week and per drinking day, and~          significantly greater increase in abstinent days, ii) greater rates of abstinence and~          abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such~          as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or~          craving,~        2. Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or~          no worsening of euthymic mood, and significant improvement on the Clinical Global~          Impressions Scale-Severity.~        3. (Secondary aims) Add-on zonisamide compared to placebo will result in significant~          reduction in weight (kilograms) and other secondary weight-related metabolic factors~          such as fasting glucose, lipid profile, and blood pressure.~        4. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical~          global impression, overall functioning, quality of life, and reduced medical symptoms.~      5.) (Exploratory Aims) To will examine interactions between genotype and medication on~     treatment response for allelic variation in genetic loci related to the major~     neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder,~     alcoholism, and zonisamide mechanism of action.~   "
113822|NCT01566357|"~     This in situ study aims to investigate~        -  the protective potential of milk and fluoridated milk on erosive wear of enamel~        -  the protective potential of milk and fluoridated milk on erosive wear of dentin~        -  to compare to protective potential of milk and fluoridated milk with products~          containing casein phosphopeptide-amorphous calcium phosphate~        -  to compare the protective potential of milk and fluoridated milk with a fluoridated~          toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)~   "
113823|NCT01566344|"~     Frequent monomorphic premature ventricular complexes (PVCs) may cause a cardiomyopathy (CMP)~     that is reversible by suppression of the ectopic focus. This study investigates whether PVC~     suppression therapy can improve cardiac function and clinical condition of patients with~     idiopathic or ischemic CMP and frequent monomorphic PVCs. For this purpose, patients will be~     randomized to either one of two treatment strategies: 1) conventional heart failure therapy~     plus PVC suppression therapy, consisting of RFCA as primary treatment and Amiodarone as~     secondary treatment in case of unsuccessful RFCA, or 2) conventional heart failure therapy~     without PVC suppression therapy.~   "
113832|NCT01566227|"~     This research is being done to find out the ideal number of implants/attachments required to~     provide adequate stability of dentures during function.~   "
113833|NCT01566214|"~     The purpose of this research study is to survey patients to learn about their beliefs and~     behaviors related to the management of heart disease and to discuss options for making~     healthy lifestyle changes. From the information the investigators get from patients, the~     investigators hope to develop better methods for taking care of patients who have heart~     disease.~   "
113824|NCT01566331|"~     Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important~     goal among obstetricians, midwifes, scientific society all over the world. Maternal and~     newborn clinical problems and complications following vaginal delivery cause a big amount of~     medico-legal problems and high costs in the sanitary field.~      Among the maneuvers that are used in the second stage of labor, uterine fundal pressure is~     one of the most controversial and often diffuse in all over the world, generally not~     documented, or under reported in medical records . Many Authors affirms that a different new~     way to push may be of help. This maneuver was introduced by Kristeller, that in 1867~     minutely described a procedure to shorten, through the application of a pressure on the~     uterine fundus whose intensity was quantified by a dynamometer and the duration measured in~     seconds, the length of the second phase of the labor. Although uterine fundal pressure~     maneuver was described by Kristeller as the placement of two hands on the uterine fundus and~     the consequential application of longitudinal steady pressure at a 30- to 45-degree angle~     directed toward the pelvis, with the avoidance of direct pressure toward the maternal spine,~     there is no clear definition of the maneuver and no indication for its use has been formally~     described to date.~      The aim of this study was therefore to assess whether the use of the Baby-guardTM system,~     through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of~     biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure~     during the second stage of labor in the direction of the pelvic outlet, may be of maternal~     and fetus aid for a safe natural childbirth for their better outcomes.~   "
113825|NCT01566318|"~     Seniors who receive supportive services face a variety of psychosocial vulnerabilities that~     put them at risk for depression. One group with very high risk is older adults receiving~     aging services through Medicaid waiver programs. This 3-year research uses a randomized~     controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem~     solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent~     depression in seniors receiving aging services.~   "
113826|NCT01566305|"~     Rationale and objective:~      Based on the results of a pilot study, the objective of the present study is to evaluate~     whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL~     cholesterol raising effects of eggs.~      Study Design:~      The study has a randomized placebo-controlled factorial 2x2 design. The total study duration~     is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period.~     Subjects will be stratified for age, gender and BMI over the experimental groups.~      Study population:~      One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly~     elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).~      Intervention:~      During the entire study period, volunteers are instructed to consume a diet according to the~     Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates).~     During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed~     milk. During the 12 weeks experimental period, a first group of subjects will continue~     drinking the skimmed milk (control group), while a second group will consume a low-fat~     buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk~     incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in~     lutein. Whole egg consumption (others than provided by us) is not allowed during the entire~     study.~      Main study parameters/endpoints:~      Measurements will be performed during the run-in period (days 0, 11 and 14) and during the~     experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk~     consumption) will be calculated as the absolute differences between values obtained at the~     end of the experimental (average days 95 and 98) and run-in (average days 11 and 14)~     periods. The primary endpoint is the change in serum LDL cholesterol concentrations.~     Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I,~     apoB and hsCRP concentrations.~   "
113827|NCT01566292|"~     The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal~     invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign~     prostatic hyperplasia (BPH).~      Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH~     and unsatisfactory response to combined medical therapy.~   "
113828|NCT01566279|"~     The investigators hypothesize that certain mutations in the individual cancer genomes will~     predict response to Everolimus therapy. To identify possible genetic mutations that affect~     tumor response to Everolimus the investigators will obtain sequence analysis of tumors from~     all patients that will be treated with Everolimus in this study. Moreover, the investigators~     performed a systematic review of the currently available data to identify mutations that~     could be predictive for increased mTOR activity in cancer cells. These mutations have been~     described to lead to mTOR activation but their predictive value for response to Everolimus~     therapy remains unclear. The investigators will use the data generated in the investigators~     own prospective treatment study and the data from literature to select patients for entry~     into a second part of this trial. In this part the investigators want to test the hypothesis~     that selecting patients based on their specific genetic mutations increases the likelihood~     of response.~   "
113829|NCT01566266|"~     It is well known that metabolic responses to diet and drugs are affected by genetic and~     environmental factors. Still, a large part of differences in responses between individuals~     remains unexplained. To increase our understanding of individual differences, more and more~     attention is paid to the role of intestinal microbiota. Not only energy and glucose may be~     related to the microbiota, but also lipid metabolism. This is not surprising as lipid~     metabolism, glucose metabolism, and obesity are closely linked.~      There is substantial evidence from in particular animal studies that the gut microbiota is~     related to lipid and lipoprotein metabolism. However, there is less evidence to what extent~     modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.~   "
113830|NCT01566253|"~     C-section deliveries are painful and need adequate analgesia. In the same time, mothers need~     early rehabilitation to take care of the baby.~      Hypothesis: Early oral self administration of painkillers could be as effective as usual IV~     administration by nursing staff.~      Purpose of the study: Evaluation of the efficacy of a program of self administration of~     painkillers postoperatively of C-section delivery.~   "
113834|NCT01566201|"~     Inhibition of interleukin-1 (IL-1) activity in patients with RA without CAD ameliorates~     vascular and LV function. Moreover, data from species shows beneficial effect of this~     treatment on LV function after experimental myocardial infarction. The purpose of this study~     is to investigate whether anakinra, an IL-1 receptor antagonist, improves vascular and left~     ventricular (LV) function in patients with coronary artery disease (CAD) and coexistent~     rheumatoid arthritis (RA).~   "
113835|NCT01566188|"~     The overall aims of the present project are to investigate the impact of a nutritional~     approach based on omega-3 from vegetal origin on vascular function in hypertension~     associated with metabolic syndrome.~   "
113836|NCT01566175|"~     The purpose of this study is to implant the Reducer in patients with the symptoms of~     refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.~   "
113839|NCT01566136|"~     Hip fractures are a danger to an individual's mobility, independence and ability to live in~     the community. When patients have a cognitive impairment (such as dementia or delirium) they~     do not recover as well or go back to their homes as often as those patients who do not have~     a cognitive impairment. Therefore, our team developed a rehabilitation model to care for~     patients with hip fractures, and specifically for those patients with CI. The model of care~     is called the Patient Centred Rehabilitation Model of Care (PCRM-CI). This 3 year study will~     focus on comparing the new model with usual rehabilitation care. This study will also focus~     on understanding the factors that could influence the use of the model on new rehabilitation~     units. The investigators hypothesize that patients who have received the new model of care~     will have better mobility outcomes over time. The investigators will collect data in 2~     hospitals, 70 patients receiving the usual care and 70 patients receiving the care in the~     new model. The team will invite 60 staff and their unit managers as well. This study will~     help decision makers to use research findings to make better decisions about care of older~     Canadians.~   "
113840|NCT01566123|"~     Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain~     disappointing even after gross total resection, mainly because wide margins are not~     achievable in the majority of patients. In contrast to extremity sarcoma, postoperative~     radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose~     and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some~     centers to overcome these dose limitations and resulted in improved outcome, local failure~     rates are still high even if considerable treatment related toxicity is accepted. As~     postoperative administration of RT has some general disadvantages, neoadjuvant approaches~     could offer benefits in terms of dose escalation, target coverage and reduction of toxicity,~     especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT)~     are considered.~      Therefore the RETROWTS trials has been designed as a prospective, one armed, single center~     phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy)~     followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable~     RSTS. The primary objective is the local control rate after five years. Secondary endpoints~     are progression-free and overall survival, acute and late toxicity, surgical resectability~     and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.~   "
113841|NCT01566110|"~     Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac~     disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to~     clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing~     will be evaluated in this study. A randomized controlled study longitudinally evaluating~     HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine~     the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.~   "
113842|NCT01566097|"~     Despite the establishment of various smoking cessation methods, including pharmacological~     intervention, only a small proportion of smokers who visit doctors choose to receive such~     assistance. Such under-utilization is especially apparent in some cultures, as in the case~     of Korea, where a government survey showed that only 0.5% of current or formal smoker~     reported they had been prescribed smoking cessation medication. Shame in asking for help for~     an addictive disorder has been recognized as one of the most recognized cultural barrier in~     Asian-American population. It is clear that culturally focused studies on smoking cessation~     is warranted.~      Patient decision aids are tools that help people become involved in decision making by~     providing information about the options and outcomes and by clarifying personal values.~     Patient decision aids have been developed to help patients decide whether to quit smoking or~     not, or whether to use smoking medication or not. However, such previous studies have only~     been focused on western populations.~      The main purpose of this study is to develop a culturally appropriate decision aid for~     smoking cessation for the Korean population, as well as evaluate its effect on their~     decision to use smoking cessation medication. The investigators expect that culturally~     tailored smoking cessation decision aids would increase knowledge about efficacy of smoking~     cessation, make people have more positive attitudes toward smoking cessation medication,~     encourage people to discuss about smoking cessation medication with their physicians.~     Ultimately the investigators expect it would increase usage of smoking cessation medication~     and enhance the quitting rate of smoking, which is a very important clinical issue.~   "
113843|NCT01566084|"~     The investigators hypothesize that reducing salt in the diet will improve the function of~     blood vessels in middle aged and older adults with moderately elevated systolic blood~     pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and~     reducing the amount of oxidative stress.~   "
113844|NCT01566071|"~     The main objectives of this study are:~        -  To evaluate the driving capacities in a population of elderly subjects with early stage~          Alzheimer Disease (AD) in a real-life situation.~        -  Define a typology of the main errors made in this population.~        -  Propose adaptive measures or technological aids that would make it possible for these~          patients to maintain their ability to drive a car while limiting risk.~   "
113845|NCT01566058|"~     The main objective of this study is to compare the degree of maternal anxiety at Day 3~     postpartum in mothers who did or did not have access to a video communication system (BB-Box~     system) from the time of initial separation with their baby.~   "
113846|NCT01566045|"~     This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion~     biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing~     subjects with prostate cancer.~   "
113847|NCT01566032|"~     The amount of air leaking from a chest tube can be measured in two main ways:~        1. electronic monitor connected to the chest tube~        2. numerical (non-electronic) monitor connected to the chest tube~      For people who have had lung surgery, it is important to understand the impact of measuring~     air leaks accurately in both the short term and the long term. An electronic medical device~     called Thopaz measures air leak electronically. Another medical device called Pleur-evac~     measures air leak numerically. The purpose of this study is to understand the accuracy of~     the method used by doctors and nurses to determine if a chest tube has an air leak. It is~     also important to determine the size or severity of an air leak.~   "
114931|NCT01551797|"~     This proof of principle study will evaluate an experimental formulation of paracetamol that~     is being developed for eventual long lasting use. This study is also used for drug safety~     evaluation.~   "
113848|NCT01566019|"~     The primary objective of the study is to use high throughput molecular analysis (CGH Array~     and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order~     to improve the progression free survival compared to the previous treatment line.~      The secondary objectives are to investigate clinical practical feasibility of such technics,~     to potentially improve the overall survival of patients and to describe molecular portrait~     of Phase 1 candidates.~   "
113849|NCT01566006|"~     Diabetes mellitus (DM) is a growing disease and it is a public health concern, and~     projections of its future effect are alarming. About one third of those affected will~     develop diabetic nephropathy at 20 years after diagnosis. Of these patients, 20% will~     develop clinically end-stage renal disease ESRD, requiring renal replacement therapy (RRT).~     Patients with type 2 diabetes account for most patients with end stage renal disease (ESRD)~     and RRT.~      To the best of the investigators knowledge, the effects of MMF on diabetic nephropathy in~     patients with DM type II were not studied so far. Therefore, the purpose of this pilot study~     is to evaluate the effects of Mofetil Mycophenolate (MMF) on proteinuria and progression of~     kidney disease of diabetic origin, in patients at high risk for progressive renal failure in~     whom other treatment modalities are insufficient or had failed.~   "
113850|NCT01565993|"~     The aim of our study is to analyze the advantages of the prophylactic use of hemoclips~     before polypectomy in our usual clinical practice, through a prospective randomized study~     that determines their effectiveness compared to conventional polypectomy, assessing the~     decrease in immediate and delayed post-polypectomy bleeding~   "
113851|NCT01565980|"~     Managing psychological and physical symptoms to improve quality of life in patients with~     lung cancer are a major public health concern. Mindfulness-based therapies are showing~     promise in modifying psychological distress and improving quality of life in some cancer~     groups, but little testing has included lung cancer samples. Mindfulness-based therapies~     integrate meditation, breathing, and gentle yoga practices to promote an attitude of~     nonjudgmental acceptance and awareness of bodily states. Such strategies may promote well~     being, self-regulation, and symptom management. The study purpose was to test the~     acceptability, feasibility, and symptom / health-related quality of life (HRQOL) outcomes of~     a home-based mindfulness intervention for individuals with advanced lung cancer during~     non-curative treatment (radiation and/or chemotherapy). Acceptability and feasibility were~     measured via patient consent and retention rates, therapy expectancy, study adherence,~     attrition reasons, and quality assurance indicators. Efficacy was determined via symptom and~     HRQOL (health perceptions, physical and emotional function) outcomes. 40 patients undergoing~     treatment of non-small cell lung cancer were randomized to receive either six weekly~     mindfulness sessions (N=20) or an attention control condition (N=20). Outcome data was~     obtained at baseline (Time 1), post-intervention (Time 2, week 8), and four weeks after~     completion (Time 3, week 11). In addition, both groups received weekly symptom assessment~     interviews. The hypothesis was that the mindfulness group would report better symptom~     management and HRQOL (lower worry, dyspnea, insomnia, depression; higher physical and social~     function; more positive health perceptions) than the attention control group at the protocol~     end and that these differences will be sustained at Time 3.~   "
113852|NCT01565967|"~     The purpose of this study is to show the success of the AutoLog System in removing lipids to~     less than 10mg/dl in vivo. The Autolog registry has two objectives:~        1. to determine the lipid removal capabilities of the Medtronic AutoLog System.~        2. to obtain in vivo data on blood component removal and washing capabilities of the~          Medtronic AutoLog System.~   "
113853|NCT01565954|"~     In Sickle cell disease children, sleep respiratory abnormalities are risk factors for~     vaso-occlusive complications, as well as cerebral vasculopathy.~      A 18 months follow-up children with sickle cell disease evaluating sleep respiratory~     problems frequency and etiology, as well as their influence on sickle cell disease~     complications.~   "
113854|NCT01565941|"~     Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels,~     is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown~     to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult~     critically ill surgical patients but has since come under intense scrutiny due to~     conflicting results in recent adult trials. One pediatric RCT has been published to date~     that demonstrated survival benefit but was complicated by an unacceptably high rate of~     severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT)~     trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose~     control in hyperglycemic critically ill children with heart and/or lung failure. Both target~     ranges of glucose control fall within the range of usual care for critically ill children~     managed in pediatric intensive care units.~      The purpose of the study is to determine the comparative effectiveness of tight glycemic~     control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of~     150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU)~     length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or~     respiratory failure. This will be accomplished using an explicit insulin titration algorithm~     and continuous glucose monitoring to safely achieve these glucose targets. Both groups will~     receive identical standardized intravenous glucose at an age-appropriate rate in order to~     provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an~     explicit algorithm combined with continuous glucose monitoring using a protocol that has~     been safely implemented in 490 critically ill infants and children.~   "
113855|NCT01565928|"~     The purpose of this study is to determine the safety of MDV3100 given in combination with~     Docetaxel in men with advanced prostate cancer.~   "
113856|NCT01565915|"~     The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.~   "
113857|NCT01565902|"~     This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate~     and severe hepatic impairment compared to healthy control subjects.~   "
113858|NCT01565889|"~     This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug~     interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral~     therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977;~     PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV)~     coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety~     of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with~     HIV/HCV coinfection.~   "
113859|NCT01565876|"~     Combat soldiers are required to perform under strenuous physical conditions; hence, their~     physical fitness is a crucial factor in their survivability.~      The Auxiliary Device- Minkal, is suggested (by its manufactures) to be able to reduce the~     soldiers' physiological strain by lowering the absolute load being carried by the soldier.~     As a result, it may improve the soldier's physiological abilities and performance through~     enduring missions with heavy loads, and may lead to better protection on the soldier from~     overuse injuries.~   "
113860|NCT01565863|"~     The purpose of this study is to test the effectiveness of the Progressive Goal Attainment~     Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans~     with disabilities.~   "
113861|NCT01565850|"~     This study is to evaluate the safety and efficacy~     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination~     (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir~     disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as~     determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.~   "
113862|NCT01565837|"~     The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as~     stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab~     (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer~     sites (oligometastatic).~      Blood samples will be collected for research purposes. Planned studies include exploration~     of certain gene mutations and serum markers as predictors of response to ipilimumab~     treatment. Research lab studies will also evaluate if circulating tumor cells (CTC) can be~     accurately detected and isolated from the blood using novel laboratory techniques and if~     they are a prognostic/predictive marker for treatment response. Test results will not be~     given to participants or their physicians. In some cases, CTC may be grown for long-term~     cell lines for further research.~   "
113863|NCT01565824|"~     The aim is to investigate whether the implementation of a web-based support to women with~     type 1 diabetes during pregnancy and early motherhood can improve well-being and self~     management of diabetes. Type 1 diabetes is associated with increased medical risks and~     increased psychosocial pressure in relation to childbearing. There is need for extended~     support from both health care professionals and peers. Web-based interventions can improve~     personal capacity and self-management in people with long- term illnesses but are not~     evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size~     browsers and mobile devices has been developed through a participatory design by~     multidisciplinary researchers, health care professionals, experienced mothers with type 1~     diabetes and web designers. In a randomised control study the developed web site offering~     information, communication with health care professionals, person-centred self-care diaries~     and online social community of included women, is provided to the intervention group in~     early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A~     control group will receive standard care (usual care). Total n = 160. Primary outcomes are~     Well-Being Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive~     solutions for strengthening patients' decision making of diabetes in daily life during~     pregnancy and early motherhood, and is expected to increase their wellbeing, personal~     capacity and knowledge of diabetes.~   "
113864|NCT01565811|"~     Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal~     cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic~     factors in oncologic surgery; however, the role of lymph node dissection remains unclear for~     colorectal cancer liver metastasis.~   "
113865|NCT01565798|"~     CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and~     mortality. Commonly touched items in the patient care environment harbor microorganisms that~     may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective~     strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a~     theoretical advantage to conventional cleaning, as disinfection is continuous rather than~     episodic.~      OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care~     unit (ICU) reduce risk of HAI.~      DESIGN: An intention to treat study where patients are sequentially placed into rooms with~     or without copper-alloy surfaced objects.~      SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer~     center, and a Veteran's Administration Medical Center.~      PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study~     hospital is eligible for placement into a study room if available.~      INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME~     MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus~     aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.~   "
113866|NCT01565785|"~     The purpose of this study is to pilot test the 'Family Self- Management Discharge~     Preparation Intervention [FSM-DPI]' that focuses on content and delivery methods to support~     an effective family transition to home self-management after a child's hospitalization.~   "
113867|NCT01565772|"~     This research study is looking at an alternative way of delivering radiation therapy with~     protons. Protons are tiny particles with a positive charge that can be controlled to travel~     a certain distance and stop inside the body. In theory, this allows better control of where~     the radiation dose is delivered as compared to photons. Information from other research~     studies suggests that proton radiation may help to reduce unwanted side effects from~     radiation and allow an increase in radiation dose that increase the odds of tumor killing.~      The purpose of this study is to determine the safest dose of proton radiation therapy to~     give in combination with standard chemotherapy in participants with Non-Small Cell Lung~     Cancer (NSCLC).~   "
113879|NCT01565616|"~     The primary goal of this multicenter study is to determine the safety and feasibility of a~     Bone Marrow Transplantation (BMT) in young adults with severe sickle cell disease (SCD)~     using a reduced toxicity conditioning regimen consisting of busulfan (Bu)/ fludarabine~     (Flu)/ anti-thymocyte globulin (ATG). A two-component design will be used for this study.~     The first component will be restricted to patients who have an HLA-identical sibling donor.~     Five patients will be enrolled during the first component of the study. The second component~     of enrollment will include patients who have a related or an unrelated HLA-matched donor. Up~     to 10 additional patients will be enrolled in this component of the study.~   "
113868|NCT01565759|"~     Psychiatric disorders often result from dysregulation in cellular and molecular mechanisms~     at the level of the brain. Unable to directly study brain tissues in patients affected by~     psychiatric conditions, researchers have created alternative experimental models that use~     different and easy to collect tissues. The underlying assumption is that by studying these~     proxy tissues, it is possible to obtain information on biological mechanisms that is a~     good approximation of what would be detected in the brain. One of the most established~     experimental models are lymphoblastoid cell lines derived from B-lymphocytes. Lymphocytes~     are present in the peripheral blood and can be easily collected and stored virtually forever~     after undergoing a special laboratory procedure that immortalize them. These cell lines have~     proved to be very useful in genetic and pharmacogenetic research and, using these, the~     investigators want to investigate the cellular effects of a mood stabilizing drug called~     lithium on this specific procedure that makes them virtually immortal. Two main reasons lead~     us to study this drug: 1) it is the most effective treatment in bipolar disorder, where~     approximately 30% of patients achieve complete illness remission with prevention of episode~     recurrence; 2) it has well established regulatory effects on the expression of specific~     target genes and proteins. The investigators can take advantage of these well-established~     properties of lithium in regulating the expression of genes, proteins, and enzymes in a~     stable manner. Conversely, these biological measures could be used as markers for the~     effects of lithium on the gene expression.~      The purpose of this study is to learn more about the changes in the activity of genes in~     cells sampled from healthy individuals treated with lithium. By studying these cellular~     changes, the investigators hope to understand if lymphoblastoid cell lines are valid tools~     in psychiatric genetics research. Specifically, the investigators want to see how specially~     treated lymphoblastoid cell lines are influenced by external conditions and specifically~     lithium treatment at the moment of sampling. To do so, the investigators will measure the~     gene expression (i.e. how much gene is in the cell) of lymphoblastoid cell lines and compare~     the levels between those sampled before and after one month of lithium treatment.~   "
113869|NCT01565746|"~     This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety,~     biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in~     Japanese patients with castration-resistant prostate cancer and bone metastases.~   "
113870|NCT01565733|"~     This study is conducted in Europe. The aim of this study is to evaluate the safety and~     efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2~     diabetes with the aim of intensifying their treatment.~   "
113871|NCT01565720|"~     This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization~     in healthy adult subjects. Eligible subjects will be randomized to one of four treatment~     groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as~     an active control on the last dosing day to healthy subjects in one of the four groups. All~     treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the~     study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on~     three study days. ECGs, vital signs, blood draws will be obtained throughout the study for~     safety and to assess the amount of study drug in body.~   "
113872|NCT01565707|"~     Solifenacin succinate as a tablet formulation is already on the market for the treatment of~     symptoms of overactive bladder in adults. For the use in children and adolescent patients a~     new formulation of solifenacin has been developed.~      This study investigated the effect and safety of solifenacin succinate liquid suspension~     compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the~     double blind period was a single-blind placebo run-in period in combination with behavioral~     urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder~     (OAB) information, awareness, instruction, life-style advice and documentation of voiding~     habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also~     investigated how well solifenacin succinate suspension is taken-up by the body and how long~     it stays in the body during this time.~   "
113873|NCT01565694|"~     The purpose of this study is to investigate a medicine for the treatment of symptoms and~     complications of neurogenic detrusor overactivity (NDO) in children and adolescents. NDO~     often occurs in patients with spina bifida or other spinal cord damage where the bladder~     muscle contracts more than normal during filling. These patients often have an inability to~     void, so that catheterization is required to empty the bladder.~      The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets~     are given to adults for the treatment of overactive bladder. A new liquid suspension has~     been developed to treat children and adolescents in this and other studies.~      The efficacy and safety of the solifenacin suspension will be investigated. The take-up and~     length of time that the solifenacin suspension stays in the body will also be investigated~     during this study.~      The study will last for approximately 12 months, where completing patients will receive 52~     weeks of continuous treatment.~      Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and~     urine volumes measured during catheterization together with the diary responses relating to~     the number of incontinence episodes or incontinence free days.~      Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of~     the kidney, simple memory and understanding tests (cognitive function) and the ability to~     see near and far objects (visual accommodation).~   "
113874|NCT01565681|"~     The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in~     healthy subjects.~   "
113875|NCT01565668|"~     This study will evaluate two doses of Quizartinib in patients with relapsed or refractory~     acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication (~     FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment~     arms. Both treatment arms will receive Quizartinib but at different doses. The study~     treatment is taken orally in 28 day cycles until either disease progression occurs or an~     unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease,~     blood will be drawn to measure drug levels and biomarkers. Patients will be followed for~     survival at three month intervals after the end of treatment.~   "
113876|NCT01565655|"~     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to~     severe rheumatoid arthritis (RA) subjects~   "
113877|NCT01565642|"~     This cluster randomized controlled trial is to examine whether decision support for goals of~     care can improve quality of communication and decision-making and improve the quality of~     palliative care for nursing home residents with advanced dementia.~   "
113878|NCT01565629|"~     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)~     program for children with anxiety and autism spectrum disorders.~   "
114019|NCT01563965|"~     Prolonged pre-operative fasting increases postoperative hospital stay and current evidence~     recommends carbohydrate (CHO) drinks 2 hours before surgery. Our hypothesis is that the~     addition of hydrolized protein to a CHO-based drink not only reduces the inflammatory~     response but also diminish hospitalization.~   "
113880|NCT01565603|"~     Mechanisms underlying high-altitude intolerance as well as exercise performance limitation~     in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances~     on one hand and cerebral perturbations on teh other hand may be key mechanisms. The~     investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7~     days in order to better describe sleep and cerebral responses. The investigators~     hypothesized that sleep and cerebral disturbances play a critical role for the developement~     of acute mountain sickness and for exercise performance limitation during acute~     high-altitude exposure.~   "
113881|NCT01565590|"~     The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage~     on dexmedetomidine compared to propofol to assess if one group has decreased inflammation.~     The investigators hypothesis is that the group assigned to receive dexmedetomidine will have~     a more profound decrease in markers of inflammation over time.~   "
113882|NCT01565577|"~     This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in~     children aged 4-8 years.~   "
113883|NCT01565564|"~     Research question (s)/hypothesis:~        1. . The effectiveness of the shared care management of gestational diabetes mellitus;~        2. . The cost-effectiveness of the shared care management;~        3. . Its sustainability~   "
113884|NCT01565551|"~     The global aim of this proposal is to test and refine Common Data Elements (CDEs),~     neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain~     Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center~     prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH),~     University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge~     (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The~     investigators will create and expand existing data repositories for patient demographics,~     neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing~     researchers and clinicians with the infrastructure to establish multidisciplinary,~     multicenter research networks and improve clinical research in the TBI field.~   "
113885|NCT01565538|"~     Both pemetrexed and erlotinib are second-line treatment options for patients with advanced~     non-small cell lung cancer. It is controversial that whether it is necessary to detect~     epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after~     the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive~     marker remains controversial. Therefore, we investigate the efficacy of erlotinib and~     pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR~     FISH-positive advanced lung adenocarcinoma.~   "
113886|NCT01565525|"~     The purpose of this pilot project is to test anticipatory guidance, which is information~     given to families during a well child visit to prevent obesity during childhood. The~     objectives were to compare two styles of anticipatory guidance during the first year of~     life, maternal focused and infant focused, versus usual care and determine which style, if~     any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were~     any differences in infant weight for height at one year of age. The investigators~     hypothesized that mothers who received the maternal focused anticipatory guidance (which~     gave information on eating family meals, not having tv on during meals, and maternal~     nutrition) would actually have the best infant feeding behaviors and weight for height of~     infants at one year.~   "
113887|NCT01565512|"~     The indwelling urethral foley is a major source of discomfort following radical~     prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with~     bupivacaine may decrease immediate post-operative foley discomfort.~   "
113888|NCT01565499|"~     Study GEICAM 2011-02 is a multicenter, open label, non-randomized phase 2 trial to evaluate~     the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive HER2~     negative patients amenable to receive neoadjuvant chemotherapy.~      The primary objetive of the trial is to determine the percentage of patients with poor~     response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual~     cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients~     with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.~      The primary endpoint of the study is to determine the residual cancer burden grade III~     (RCB-III) after surgery.~      The total number of patients to be included in this study is 78 patients.~      The duration of the study, from first patient visit to last patient visit will be~     approximately 90 months (Including follow-ups)~   "
113889|NCT01565486|"~     The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device~     (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure~     Precise™, Covidien) in surgery for thyroid cancer.~      Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES),~     Recurrence-free survival (RFS), Overall survival (OS)~   "
113890|NCT01565473|"~     This research plan is focused on neurochemical positron emission tomography (PET) studies of~     Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and~     considerable progress has been made in understanding and treating the typical movement~     abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are~     all initially responsive to dopamine replacement therapy, and have been investigated~     intensively with respect to their relationships to degeneration of the nigrostriatal~     dopamine projection. More recently, increased attention has focused on the non-motor~     clinical aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic~     defects. These clinical features are less reliably affected by dopaminergic therapy, and are~     likely to be associated with other, non-dopaminergic neural degenerations. Indeed, detailed~     postmortem assessments of PD brain reveal substantial neuronal losses in a variety of~     chemically-defined neurons, including brainstem serotonin and norepinephrine neurons and~     basal forebrain cholinergic neurons. Projects in the proposal will focus on dementia,~     depression, sleep-apnea and dysautonomia in PD patients, employing PET measures of~     presynaptic dopaminergic, serotoninergic and cholinergic CNS neurons and of peripheral~     sympathetic neurons. Results of the investigations may identify associations of non-motor PD~     signs and symptoms with the non-dopaminergic neuronal losses. These findings will establish~     additional therapeutic targets for symptomatic, but also for potential neuroprotective PD~     therapies. In addition, a majority of patients will be characterized with all 3 CNS PET~     measures. The availability of multiple markers of distinct neuronal populations involved in~     PD neurodegeneration will permit exploratory analyses to assess whether the degenerations~     are correlated (possibly manifestations of a common pathophysiology) or apparently~     independent (possibly a manifestation of multiple PD subtypes or pathophysiologies).~     Ultimately, better understanding of these non-motor features will be essential to developing~     future treatments that address the entire PD patient.~   "
113891|NCT01565460|"~     The purpose of this study is to create a long-term storage of bile and brushings of~     pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future~     research.~      Recently, a lot of research has been done to test for certain markers in the bile and~     brushings to detect cancer in a stricture. The samples will be used to measure biomarkers~     (proteins) in biliary diseases.~   "
113892|NCT01565447|"~     This purpose of this study it to characterize the walking patterns of children diagnosed~     with Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in~     the treatment protocol and after completion of treatment. Their walking patterns will be~     compared to children without ALL or LL to see if their walking patterns are different at~     specific times in their treatment program or up to 10 years after completion of their~     treatment. The investigators will gather data by observing how the child walks, runs, hops~     on one foot and climbs stairs and by recording walking patterns on a pressure sensitive mat.~     The investigators will compare this data to children without ALL and LL.~   "
113893|NCT01563523|"~     This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this~     trial is to evaluate the efficacy of activated recombinant human factor VII given in~     conjunction with standard therapy in the treatment of massive bleeding in subjects with~     severe blunt and/or penetrating trauma injury.~   "
113894|NCT01563510|"~     The purpose of this research is to investigate the key technology and the related issues of~     minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive~     operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic~     operation were assessed objectively through our clinical prospective study. The technique~     points, indications and contraindications were summarized to evaluate the status and role of~     minimal invasive laparoscopic operation in the treatment of hepatolithiasis.~   "
113895|NCT01563497|"~     The primary purpose of this study is to estimate the relative bioavailability and food~     effect of a PF-05089771 tablet.~   "
113896|NCT01563484|"~     Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the~     world. In men is the fifth most frequently diagnosed cancer worldwide but the second most~     frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer~     and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and~     695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were~     estimated to occur in China. Surgical resection and liver transplantation can be curative~     treatment options, but less than 20% of PHC patients are candidates for surgery. The~     prognosis of patients with unresectable PHC is poor; if left untreated, the median survival~     is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a~     palliative treatment in patients with unresectable HCC, it has become one of the most common~     forms of interventional therapy. However, the possibility of treatment-related complication~     may offset the survival benefit, especially by the worsening of liver functions.TACE~     increases several parameters of hepatic cytolysis and decreases the metabolic activity of~     the liver. Such a deterioration of liver function due to ischemia following TACE may result~     in liver failure, or even death. TACE also may have an adverse effect on the kidney.~     Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown~     that the use of contrast medium increases the risk of renal failure, especially the~     low-osmolar contrast media. The aim of this trials was to compare the change of liver and~     renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar~     contrast media.~   "
113897|NCT01565434|"~     Main objective: investigate whether a functional polymorphism of CR1 (length, number of~     binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined~     genetic or acquired, is a susceptibility factor for the disease Alzheimer's.~   "
113898|NCT01565421|"~     This study will assess the effect of IT-101 on delaying cancer progression in patients with~     platinum sensitive ovarian cancer.~   "
113899|NCT01565408|"~     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the~     safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid~     arthritis (RA).~   "
113900|NCT01565395|"~     The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A~     (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's~     Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.~   "
113901|NCT01565382|"~     Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers~     trained using updated reading methodology. The scans in this study came from subjects who~     had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).~   "
113902|NCT01565369|"~     The purpose of this study is re-read of brain amyloid positron emission tomography (PET)~     scans acquired in previous florbetapir F 18 clinical studies by readers trained using~     updated reading methodology. The scans in this study came from subjects who had an autopsy~     to reveal the subject's true amyloid status.~   "
113903|NCT01565356|"~     This study will re-read 10-minute positron emission tomography (PET) scans acquired in~     previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the~     results.~   "
113904|NCT01565343|"~     This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy~     volunteers provide the same results. The study will also test two different AV-45 injection~     methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).~   "
113905|NCT01565330|"~     This study will test two different doses of florbetapir F 18 to determine which dose is best~     to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron~     emission tomography (PET) scanner.~   "
113906|NCT01565317|"~     The purpose of this study is to find out the impact of improving diabetes control through~     weight reduction and lifestyle changes on a common diabetes complication called peripheral~     neuropathy.~   "
113907|NCT01565304|"~     The purpose of this study is to evaluate the effectiveness of the POWER Through Choices~     (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth~     living in group foster care homes.~   "
113908|NCT01565291|"~     A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies~     of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron~     emission tomography (PET) scanner.~   "
114020|NCT01563952|"~     Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates,~     because lumen and stent dimensions can be accurately determined by intravascular ultrasound~     (IVUS).~   "
114219|NCT01561144|"~     The purpose of the study is to analyze the different patient profiles implanted with an~     Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient~     prognosis as a function of clinical profile, implant indication, arrhythmias incidence,~     treatments or device programming.~   "
113909|NCT01565278|"~     Patients who are not able to eat normally for a longer time require parenteral nutrition,~     i.e. they receive liquids and nutrients directly into their veins. This can have many~     long-term side effects, including liver problems. This study will examine whether a specific~     lipid emulsion containing fish oil can improve liver disease in patients on parenteral~     nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3~     months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard~     lipids + a fish-oil containing emulsion. The investigators will also assess liver histology,~     the kind of fat, oxidative stress and gene expression in the liver at the beginning and~     after 6 months of fish-oil. The investigators also want to compare the baseline values from~     all 20 patients to 20 healthy controls. This will help to explain how fish oil may improve~     liver disease in patients on parenteral nutrition.~   "
113910|NCT01565265|"~     The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist~     (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women~     undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI~     treatment because of male infertility.~      To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or~     a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to~     determine the safety of ovarian stimulation.~      Subsample analysis: in 10 patients of each of both arms, serum samples will be collected~     daily during the stimulation period and be stored frozen at -70 °C. The following hormone~     concentrations will be measured later in single assay batches: LH, FSH, oestradiol,~     progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.~      Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study.~     Eligible patients will be randomly allocated to one of the two groups: the agonist group~     will receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the~     natural cycle until downregulation until the day of ovulation induction. The antagonist~     group will receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both~     groups, Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation~     from cycle day 2 to ovulation induction.~   "
113911|NCT01565252|"~     Study Rationale:~      As epidemiological research has shown negative effects of high egg consumption on increased~     all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate~     their effects on diseases risks, it is important to test the effect of eggs with different~     composition on markers associated with dyslipidemia, dysglycemia and inflammation.~      The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to~     omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.~   "
113912|NCT01565239|"~     Experiments suggest that during treatment with vitamin K antagonists (VKA) the activity of~     coagulation factors (F) II and X better reflect anticoagulation than does FVII. Based on~     this a new prothrombin time based monitoring test (Fiix-PT) has been invented which is only~     sensitive to FII and FX. The Fiix-PT can be converted to INR (Fiix-INR).~      The investigators hypothesize that the Fiix-PT may reflect anticoagulation and the~     antithrombotic effect of VKA as accurately or better than the current PT based tests do (INR~     based on PT or P&P). The protocol describes a prospective randomized double-blind trial that~     will be conducted at the Landspitali Anticoagulation Management Center (AMC).~      The objective of the protocol is to evaluate the efficacy and safety of Fiix-INR as a~     monitoring test compared to the current PT based assays (INR) used to monitor patients~     treated with VKA to prevent thromboembolism. The investigators will randomize 1200 clients~     of the AMC into two identically sized monitoring groups, Fiix-INR (test group) and INR~     (control group).~      The clinical endpoints to be studied include efficacy (arterial and venous thromboembolic~     event rate) and safety (bleeding events). Additionally, surrogate convenience endpoints will~     be studied such as test frequency and time within target range.~   "
113913|NCT01565226|"~     -  This will be an observational study. Respiratory data will be recorded using~          Capnostream20p. There will be no use in the recorded data for the medical care of the~          patients. Other clinical data will be captured in the CRF. Similar study is currently~          conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited~          without any adverse events.~        -  During the study the medical team will capture in the CRF the following: Blood gas and~          distal capnography values at time of sampling, ventilator settings at time of sampling.~        -  Changes made in the ventilation parameters, blood gas time and results, concomitant~          treatment (e.g. suction) and concomitant medication (respiratory related e.g.~          surfactant), vital signs all these will be retrieved from the patient's medical charts.~   "
113914|NCT01565213|"~     The purpose of this study is to compare the effects of CBT and MMI on the quality of life~     and relief of psychological symptoms of patients with common mental disorders or problems~     attending primary health care centre.~   "
113915|NCT01565200|"~     T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the~     coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine~     derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35%~     objective response rate, 44% stable disease, 18% progressive disease) in patients with~     advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab~     and lapatinib.~      Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is key since~     the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the~     external domain of HER2.~      The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test~     which shows promise in measuring HER2 expression (extracellular domain) for the entire~     disease burden and which could identify non responding patients prior to TDM1~     administration.~      Rationale II: As for many such agents, it is desirable to identify early on (here with the~     use of FDG-PET/CT) which patients are unlikely to benefit from the therapy~   "
113916|NCT01565187|"~     A prospective multicenter study utilizing standardized instruments for the psychological~     assessment of hand transplant candidates pre and post-transplant as well as those candidates~     excluded for transplantation.~   "
114033|NCT01563783|"~     This Post Market study is being conducted to compare the direct and indirect cost of three~     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of~     symptomatic uterine fibroids.~   "
113917|NCT01565174|"~     There is growing evidence of high rates of substance use disorders among individuals with~     psychotic disorders especially in young people with predisposition for psychosis. There is~     some genetic evidence that carriers of the valine158 allele of the~     catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms~     and to develop schizophrenia if they used cannabis by the age of 18. It was also shown that~     carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic~     experiences but this was conditional on pre-existing susceptibility to psychosis. The~     investigators propose to use brain-imaging and molecular genetics to investigate whether~     genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis-~     induced psychosis.~   "
113918|NCT01565161|"~     While childhood obesity rates may have plateaued in some US population subgroups, such as~     whites and those of higher socioeconomic status, overall rates of obesity remain high and~     racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising~     approaches for childhood obesity prevention and management are interventions that begin~     early in life and that support change at the individual and community levels.~      The goal of this project is to develop and test an intervention delivered to racial/ethnic~     minority and low income parents of 2-5 year old children in their homes, designed to promote~     adoption of household routines and parenting strategies that are preventive of obesity. To~     achieve this goal, the investigators will work with community health centers in Boston,~     Cambridge, and Somerville to recruit families to participate in an individual-level~     randomized controlled trial. The investigators partner community health centers include the~     Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the~     Cambridge Health Alliance (CHA).~      Participants will be randomized to receive either 1) mailed educational materials for the~     duration of the 6-month program (control), or 2) home-based health coaching visits and phone~     calls with a health educator, text messages, and educational materials promoting the~     adoption of household routines and target behaviors (intervention).~      The investigators goal is to evaluate the feasibility and effectiveness of the investigators~     designed intervention (as compared to the control condition) using baseline and~     post-intervention data. In order to do so, the investigators will assess change from~     baseline to post-intervention in the investigators key behavioral outcomes of interest,~     including adoption of three household routines:~        1. Regularly eating meals together as a family~        2. Obtaining adequate sleep~        3. Limiting screen-viewing time~   "
113919|NCT01565148|"~     -  To assess the safety of repeated iCo-007 intravitreal injections in treatment of~          subjects with diabetic macular edema as monotherapy and in combination with ranibizumab~          or laser photocoagulation~        -  To assess the change in visual acuity and retinal thickness on OCT from baseline to~          month 8 and month 12~   "
113920|NCT01565135|"~     The purpose of this study is to determine if a multimodal immunization program carried out~     in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn~     patients' immunization rates, specifically for Tdap, HPV, and influenza vaccines, than the~     usual care provided to patients in ob/gyn practices.~   "
113921|NCT01565122|"~     This multi-center, observational study will evaluate the clinical practice patterns,~     efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid~     arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra~     treatment by their treating physician according to approved label for up to 12 months from~     start of treatment.~   "
113922|NCT01565109|"~     It is estimated to 7300 the number of new cases of gastric cancer each year in France.~      According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU)~     administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma~     of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant~     chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a~     median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of~     chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with~     chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly~     prolonged with a hazard ratio of 0.66.~      The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the~     schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple~     combination as a reference treatment in metastatic gastric cancer in patients under 65~     years.~      Preoperative radiochemotherapy is expected to increase the rate of curative resections,~     reduce gastrointestinal and hematologic toxicity.~      Two studies evaluating the feasibility of preoperative RTCT in operable gastric~     adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the~     combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.~      The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with~     Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous~     5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV~     non-metastatic administered before surgery.~   "
113923|NCT01565096|"~     The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to~     glimepiride on beta cell function and the cardiovascular risk profile in patients previously~     treated with Metformin monotherapy.~   "
113924|NCT01565083|"~     This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy~     of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first~     line participants with metastatic or locally advanced HER2-positive breast cancer.~     Participants will receive pertuzumab and trastuzumab administered sequentially as separate~     intravenous (IV) infusions (followed by vinorelbine) and conventional sequential~     administration of pertuzumab and trastuzumab in separate infusion bags, followed by~     vinorelbine.~   "
113925|NCT01565070|"~     Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies~     in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively,~     which is produced by menthol, apparently through the newly discovered receptor TRPM8~     (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if~     BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated~     with moderate knee osteoarthritis, which would decrease the immobility and isolation in~     older adults.~   "
113926|NCT01565057|"~     This comparative study is designed to compare the gastric layering and rates of emptying and~     by inference rates of digestion of two food emulsions. Two types of dairy based foods will~     be used, one which will sediment in the stomach and one that will not. On each of two study~     days, a total of 9 post drink MRI scans will be taken to assess gastric layering and~     emptying. Cannulation will allow blood samples to be taken periodically for subsequent~     analysis for the presence of specific digestion related hormones. A total volume of 36 ml of~     blood will be removed and volunteers will also be asked to complete a questionnaire at~     predetermined times to assess feelings of satiation.~   "
114932|NCT01551784|"~     The aim with this study is to investigate the effect of statin induced changes in HDL-C on~     all cause mortality and CVD with adjustment for changes in other blood lipids and clinical~     parameters in Sweden, UK and the Netherlands.~   "
113927|NCT01565044|"~     Many patients retain upper-limb motor impairment following stroke. Most conventional~     rehabilitation techniques are aimed to improve motor intentional movement by repeated~     exercises. These techniques require attentional load and are responsible for significant~     fatigue that probably represents a limiting factor. Alternatively, the automatic control of~     action is now well documented. A rehabilitation method based on this principle could allow~     recovery of more natural movements.~      Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a~     rehabilitation technique based on intentional movements.~   "
113928|NCT01565031|"~     The optimal score to predict unfavourable outcome in well-controlled asthma patients who are~     undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is~     warranted to prospectively develop a prognostic system -easy to perform (suitable for use in~     the clinical rather the research setting)- for asthmatic patients in this clinical setting.~      HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in~     well-controlled patients who are undergoing a step-wise down-titration of their medication~     according to international guidelines.~      METHODS The investigators designed a prospective, multicenter, observational study at five~     centers in cities across Spain.~      The patients group (N = 225) will be evaluated to produce a clinical prediction rule for~     loss of control. The investigators will consider the following variables in the risk factor~     analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient~     of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction~     of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.~      The score model will be prospectively validated in an independent set of 113 patients.~   "
113929|NCT01565018|"~     To investigate and compare the drug amount delivered to the body after each single~     administration of Rotigotine patch with 2 different formulations in healthy Japanese~     subjects.~   "
113930|NCT01565005|"~     The purpose of this study is to:~      I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by~     ASPM mutations already characterized and published (Passemard et al. 2009a) with other~     MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT~     mutations)~      II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients~     suffering from Fanconi anemia, and compared them to subjects with:~        -  Fanconi anemia but normal OFC (head circumference)~        -  MCPH patients~        -  Healthy control subjects Our hypothesis is that mutations in genes responsible of~          microcephaly impact differentially cortical brain development and functioning~   "
113931|NCT01564992|"~     This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of~     treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients~     will be followed annually for up to 5 years. A biological collection will be associated with~     a full clinical assessment of motor and non motor symptoms, medical and treatment history,~     environmental factors. The association between candidate gene polymorphisms and disease or~     treatment complications will be analyzed.~   "
113932|NCT01564979|"~     The purpose of this study is to determine whether pretarsal and preseptal techniques of~     Botulinum toxin type A injection have any effect on tear functions.~   "
113933|NCT01564966|"~     -  A reduce in renal mass may result in remnant single nephron hyperfiltration, with~          associated proteinuria and an accelerated loss of kidney function.~        -  Live-donor kidney transplantation is generally considered the best choice for patients~          who have renal failure and are awaiting transplantation, because these kidneys function~          better than kidneys from deceased donors, and waiting times for deceased-donor~          transplants are long~        -  Although several studies have shown that kidney donation has low short-term morbidity~          and mortality, the data on long-term outcomes are much less complete.~        -  This study is designed to prospectively evaluate the effects of unilateral nephrectomy~          on cardiovascular-renal functions of donors after living kidney donation: the~          development of hypertension, albuminuria, renal failure, inflammatory and endothelial~          changes.~   "
113934|NCT01564953|"~     This study will investigate the serum level of vitamin D, magnesium and calcium in patients~     with chronic obstructive pulmonary disease (COPD) in order to evaluate the impact of vitamin~     D, magnesium and calcium on lung function in COPD-patients.~   "
113935|NCT01564940|"~     The purpose of this study is to obtain subjective feedback in a home use environment~     regarding usability and ease of use of the applicator and conception cap and the~     instructions for use. Data will be collected and evaluation to determine if the usability~     requirements of the conception system as determined by the usability specification have been~     met. The study will not involve sexual intercourse or delivery of any fluids to the cervix.~     The study will only involve use of the applicator to insert the cervical cap into the~     vagina, track it to the cervix and prepare and release the cervical cap (with removal string~     attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.~   "
113936|NCT01564927|"~     The aims of the study are to investigate the physiological responses associated with deqi~     during stimulation of the LI11 and LI4 acupuncture points and the correlation between the~     intensity of the deqi sensation to such responses.~   "
113937|NCT01564914|"~     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with~     recurrent or progressive glioblastoma after prior antiangiogenic therapy (including~     anti-VEGF therapy)~   "
113938|NCT01564901|"~     This prospective, observational, multicenter study will assess the efficacy and safety of~     RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to~     severe rheumatoid arthritis and an inadequate response to previous disease-modifying~     antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.~   "
113939|NCT01564888|"~     Evaluating the effect of ulnar artery compression while pressing on radial artery to stop~     bleeding, in maintaining radial artery potency, after cardiac catheterization through the~     radial artery. We prospectively plan to compare 3000 patients referred for cardiac~     catheterization, randomized into two groups, one group receiving radial artery compression~     for stopping bleeding, in a standard fashion following best practices, and the other group~     receiving radial artery compression using standard best practices and ulnar artery~     compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure~     to evaluate its potency, using plethysmography.~   "
113940|NCT01564875|"~     Study design~        -  Multicenter, double-dummy, double-blinded, randomized, Phase 4 study~        -  Patients will be randomized to either a study group or a control group in a 1:1 ratio,~          and will be orally administered the assigned drugs~      Study Objective~      -The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast~     Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with~     stage 3,4,5 chronic kidney disease with hyperlipidemia~      Primary objective~      -to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney~     Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.~   "
113941|NCT01564862|"~     The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on~     cognitive dysfunction in patients with major depressive disorder.~   "
113942|NCT01564849|"~     An explosion of interest in the numerous therapeutic properties of Punica granatum over the~     last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a~     potent antioxidant, superior to red wine and equal to or better than green tea. In addition,~     anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or~     adjunct for prevention and treatment of several types of cancer and cardiovascular disease.~     Because of pomegranate's antimicrobial properties, it may aid in preventing infection by~     dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as~     methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial~     pathogens has only been tested in vitro, however, necessitating human trials to refute or~     substantiate any clinical effect.~      The possibility that pomegranate extracts may also have an effect on several other disease~     processes, such as Alzheimer's and obesity, underscores the need for more clinical research.~     Currently, numerous clinical trials are in progress exploring the therapeutic potential of~     pomegranate extracts.~      Aim The investigators want to evaluate the effect of Punica granatum components on Chronic~     sinusitis, nasal polyps and chronic rhinitis.~   "
113943|NCT01564836|"~     This prospective study is performed to identify safer and more concrete indicators of~     successful discontinuation and explore contributing factors for sustained undetectable~     transcript~   "
113944|NCT01564823|"~     The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on~     prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease~     patients after 52 weeks of treatment.~   "
113945|NCT01564810|"~     In this study, the investigators assessed the effect of Cetuximab in combination with~     chemotherapy in the treatment of unresectable metastatic colorectal cancer.~   "
113946|NCT01564797|"~     The aims of the study are to investigate~        1. the effects of an intervention vs. control on levels of glycosylated haemoglobin~          (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c~          at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar~          levels over the past 3 months. Elevated hA1c levels are seen in diabetics and~          pre-diabetics.~        2. the effects of the intervention vs control on consumption of fresh fruit and vegetables~        3. the effects of the intervention vs control on levels of physical activity~   "
113947|NCT01564784|"~     This study will compare the efficacy, in terms of complete responses and overall survival,~     of inotuzumab ozogamicin versus investigator's choice of chemotherapy.~   "
113948|NCT01564771|"~     Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates~     and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates~     collected each year are limited and depict a certain proportion of patients who have easy~     access to tertiary care or have underlying medical reasons which necessitate inpatient care.~     It is also probable that the real burden of pneumococcal disease is not well estimated~     especially among adults. New additions in the laboratory setting such as the pneumococcal~     urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the~     detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might~     be helpful in identifying more pneumococcal infections compared to the previous years. This~     NIS is based on the unmet scientific need to describe the serotype distribution and the~     resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.~   "
113949|NCT01564758|"~     The purpose of this study is to determine if Linezolid is safe for adult Filipino patients~     diagnosed with gram positive infections.~   "
113950|NCT01564745|"~     In our knowledge there is only few data about the cough determinants in mechanically~     ventilated patients. However some failure of extubation is due to inefficiency cough. In~     order to determine some determinants of cough, the investigators propose to evaluate~     systematically different physiological parameters before and after extubation.~   "
113951|NCT01564732|"~     The purpose of this study is to compare plicated laparoscopic adjustable gastric banding~     (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective~     randomized clinical trial. We hypothesize the plicated procedure will provide greater short-~     and long-term excess weight loss than the standard procedure. There exists little~     prospective randomized data regarding this topic and the recent position statement from the~     American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study.~     Further information on background and design of this study are provided in the detailed~     description.~   "
113952|NCT01564719|"~     This study seeks to test a two-year intervention designed for United Methodist clergy. The~     intervention consists of: the stress reduction program Williams LifeSkills, adapted for~     clergy; the 10-session online weight loss program Naturally Slim Foundations plus its~     7-session online booster program, Naturally Slim Advanced; monthly phone conversations with~     Wellness Advocates who function as health coaches; and three in-person workshops that cover~     the theology of the body and incarnation and provide the religious rationale for caring for~     the mind and body. Participants were randomly assigned to one of three cohorts, all of which~     will eventually receive the intervention but which differ by intervention timing, thereby~     building in a randomized waitlist control group. The investigators hypothesize that~     intervention participants will achieve reductions in metabolic syndrome, depression, and~     stress, and achieve improvements in quality of life and spiritual well-being, compared to~     the waiting control group participants.~   "
113953|NCT01564706|"~     This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed~     throughout the body.~   "
113954|NCT01564693|"~     The pathogenesis of cancer anorexia is complex and multifactorial. However, a number of~     consistent and robust evidence point to a prominent role for the central nervous system. In~     particular, the hyperactivation of the immune system, due to tumour growth, causes a~     systemic inflammatory response primarily mediated by pro-inflammatory cytokines. At the~     central level, inflammatory response profoundly alters the activity of the hypothalamic~     nuclei, which are involved in the regulation of energy homeostasis. In particular,~     pro-inflammatory cytokines inhibit prophagic neurons activity, while enhance the activation~     of the anorexigenic neurons. Although supported by compelling experimental evidence, it~     should be acknowledged that this pathogenic hypothesis has not been confirmed yet by human~     studies.~      Aim of the present study is to determine the specific pattern(s) of the brain activation~     after assumption of a standard meal in both anorexic and non-anorexic cancer patients to~     reveal potential differences, which will be correlated with the levels of concurrently~     measured circulating pro-inflammatory cytokines. The results obtained would help in~     assessing the role of the central nervous system and, in particular of the hypothalamus, in~     the pathogenesis of cancer anorexia.~   "
113955|NCT01564680|"~     Background: The aim of this prospective, randomized, double-blind study is to determine the~     most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain~     relief after lower abdominal surgery.~      Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were~     randomly allocated to receive either isotonic saline (Control group), intravenous~     paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h~     (Lornoxicam group). Additionally pain was treated postoperatively using morphine~     patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score~     (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8,~     12 and 24 hours postoperatively.~   "
113956|NCT01564667|"~     Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either~     Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a~     placebo control condition not designed to change attention patterns. Outcome measures will~     be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological~     interviews and questionnaires. Participants will also be invited to participate in~     physiological testing before and after receiving AMBT or placebo to serve as additional~     outcome measures and assess brain functioning, heart rate, and muscle tension.~      The investigators expect to see significant PTSD symptom reduction in the Attention Bias~     Modification Treatment (ABMT) group relative to the placebo control group in which no~     symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective,~     we will offer active ABMT to those participants randomly assigned to the placebo arm if they~     would like to receive the treatment.~   "
113957|NCT01564654|"~     This study involves retrospective collection of data regarding the first approximately 100~     iTotal Knee Replacement System surgeries and their short term outcomes at a small set of~     centers throughout the US.~   "
113958|NCT01564641|"~     To evaluate the ConforMIS iDuo G2 implant~   "
113959|NCT01564628|"~     The purpose of the study is to optimize an already existing algorithm for diagnosing~     atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).~   "
113960|NCT01564615|"~     The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the~     occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.~   "
113961|NCT01564602|"~     The main objective of this trial is to assess the efficacy and safety of single port-access~     laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood~     loss and hospital stay will be record, respectively. The pain score is based on the visual~     analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours~     after surgery.~   "
113962|NCT01563471|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics of three different single doses activated recombinant human factor VII in~     Caucasian and Japanese healthy subjects.~   "
113963|NCT01563458|"~     This trial is conducted in Europe, North America and Oceania. The aim of this trial is to~     evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects~     undergoing orthotopic liver transplantation surgery.~   "
113964|NCT01563445|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the safety and preliminary efficacy of activated recombinant human factor VII~     (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).~   "
113965|NCT01563432|"~     This study was designed to compare and evaluate the pharmacokinetic characteristics of~     febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in~     healthy adults; and to evaluate safety and tolerance following a single-dose administration.~   "
113966|NCT01563419|"~     Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit~     inadequate glycemic control in spite of combination of oral antidiabetic drugs and~     eventually need insulin therapy. Patients who need insulin therapy are older and have poor~     visual acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In~     this study, the investigators examined the clinical usefulness of a magnifier for elderly~     diabetic patients who had used insulin pens.~   "
113967|NCT01563406|"~     Central venous catheter infections are common preventable adverse events among hospital~     patients. Microbes may enter catheter hubs, also known as needleless connectors, and result~     in downstream contamination. This study aims to compare alcohol disinfection of catheter~     hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a~     superior disinfectant at the site of central venous catheter insertion. Scrub duration of~     central venous catheter hubs will also be evaluated.~   "
113977|NCT01564511|"~     Multiple Sclerosis is a very disabling disorder in young adult patients leading to an~     important limitation in daily life activities and social participation. Among of the~     different causes of disability in MS patients gait impairments, fatigue and balance~     disorders can be considered as the main concerns. Thus, gait restoration in patients with MS~     is the one of the primary objective of rehabilitation and often influences whether a patient~     can return home or to work. Even if potentially innovative treatments like treadmill~     training have been proposed, nowadays the role of robotic assisted locomotion rehabilitation~     has not been extensively studied in patients with MS.~   "
113968|NCT01563393|"~     Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic~     malnutrition caused by chronic diseases. According to various studies, about 10-20% of those~     admitted to hospitals in different countries suffer from malnutrition or are at risk of~     malnutrition.~      Several pediatric nutritional screening tools were recently published. However, there is no~     conventional pediatric nutritional screening tool and the effect of the recently published~     tools on further nutritional risk and the behavior of the attending staff are unclear.~      Study objectives: to test the validity and reliability of the STAMP nutritional screening~     tool (Screening Tool for the Assessment of Malnutrition in Pediatrics) among children~     hospitalized in a pediatric medical center and to examine the effect of the STAMP tool use~     on the attitude of the medical staff to the patient nutritional status.~      An additional objective is to compare the skill of a nurse versus a dietician in performing~     the evaluation according to STAMP.~      Methods: for the validation, 50 children between 1 and 17 years of age from internal~     medicine and surgical departments will undergo a complete evaluation by an investigating~     dietician and assessment by the STAMP tool in order to determine the extent of the~     nutritional risk on a numerical scale. All the children will undergo STAMP evaluation by a~     nurse and another investigating dietician as well.~      In order to examine the effect of the tool on the medical staff awareness, 300 files of~     hospitalized children will be tested: 150 files at the beginning of the study and prior to~     using the tool and 150 after 6 months at the same ages and in the same departments.~      The effect of using the STAMP questionnaire will be examined according to the results of~     data collection from the beginning of the study and after 6 months. Questionnaire use,~     recording of appropriate diagnoses, collection of blood tests demonstrating the nutritional~     status, weight, height and waist circumference measurements will be obtained from the~     patients' medical files.~   "
113969|NCT01563380|"~     This study was designed to evaluate the efficacy of leucocyte free autologous platelet rich~     plasma on blood loss, pain, wound healing and functional outcome after total knee~     arthroplasty. The investigators hypothesized that application of platelet rich plasma would~     help in reducing blood loss, postoperative pain and expedite wound healing and better~     short-term functional outcome following total knee arthroplasty.~   "
113970|NCT01563367|"~     The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000~     (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level~     in non-anaemic patients undergoing cardiac surgery~   "
113971|NCT01563354|"~     This is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a~     single-stage design in each arm. The purpose of this study is to test the effectiveness and~     safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with~     advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the~     lung and thymus. It is expected that a total of 120 patients with 40 patients in each arm~     will be enrolled into this study. Patients with disease control (SD or better) in the~     combination arm or monotherapy with pasireotide LAR and everolimus and who are not~     experiencing unacceptable toxicity are permitted to continue treatment after the 12 month~     treatment period in the extension phase of the study. Primary Endpoint is defined as the~     proportion of patients who are progression-free at 9 months according to RECIST V 1.1~   "
113972|NCT01564576|"~     The aim of the present study is to prospectively assess whether deep neuromuscular blockade~     (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses~     using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex~     (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end~     of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients~     undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing~     deep NMB throughout the procedure creates better conditions for surgery, while reversal of~     deep NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and~     fewer postoperative respiratory events as compared to neostigmine (Prostigmin®,~     Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an~     expected average of 7 days.~   "
113973|NCT01564563|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in~     patients having undergone a hematopoietic stem cell transplantation.~   "
113974|NCT01564550|"~     In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics~     in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The~     kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The~     investigators hypothesis is that the investigators will find an increased VLDL1 production~     in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators~     wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males,~     where the investigators expect less variance in VLDL production when the subject is given an~     isocaloric diet.~   "
113975|NCT01564537|"~     The purpose of this study is to determine whether the addition of oral ixazomib to the~     background therapy of lenalidomide and dexamethasone improves progression free survival~     (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).~   "
113976|NCT01564524|"~     Traumatic facial injuries, especially those sustained in military combat, are characterized~     by destruction of bone and soft tissue. While the bony structures of the face can be~     reconstructed, it is difficult to return the soft tissue back to its original form. Many~     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of~     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat~     is taken from areas throughout the body, usually the thighs or abdomen, with a small~     liposuction tube. The fat is then transferred into the area that has lost volume or~     fullness. The fullness of the soft tissue area may decrease over time because the~     transferred fat can be reabsorbed by the body. Altering the current fat grafting procedure,~     slightly, could lead to less reabsorption and a lasting fullness of the soft tissue area~     outcome of the fat graft procedure.~      We are conducting this research study to help us improve the surgical treatment of people~     who have suffered facial soft tissue loss as a result of trauma. The goal of this research~     study is to see how each person's fat grafts will maintain the fat over time and to measure~     the quality of life during a 9 month post-surgical follow-up period. The total duration of~     participation is approximately 11 months.~      In this study, we will concentrate the fat in the fat grafting procedure to determine~     whether this process will maintain the fat over time. The areas treated with enhanced fat~     grafts will be compared with areas treated with standard of care fat grafts. At least two~     areas of your face will be treated with fat grafts, (standard of care fat grafts and~     concentrated fat grafts).~   "
114002|NCT01564186|"~     The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac~     hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class~     assessment and echocardiographic measurements are performed at 3 months and 12 months~     post-implant to characterize long-term effect of MPP.~   "
116951|NCT01525212|"~     The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid~     (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype~     subtype 1a and 1b HCV infected subjects~   "
113978|NCT01564498|"~     The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds~     including anthocyanins will have higher antioxidant and other biological activities, than~     more lightly coloured versions of these foods. Diets of human subjects will be modified to~     allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be~     randomized to consume either orange or purple carrots, or white or purple potatoes. They~     will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined~     as well as anthropometry and blood biochemistry for changes in risk factors associated with~     cardiovascular disease.~   "
113979|NCT01564485|"~     This study looked at the role of cardiac CT in improving risk factor control in those with~     diabetes.~   "
113980|NCT01564472|"~     The objective of this study is to validate the ability of the Sleepware G3 polysomnography~     software platform to correctly identify and score sleep related events.~   "
113981|NCT01564459|"~     The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the~     treatment of painful diabetic neuropathy (PDN) in adults.~   "
113982|NCT01564446|"~     Background and Significance: Adverse drug events (ADE) are the most common of all healthcare~     associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE~     and avoidable healthcare utilization affecting up to 20% of patients. Insufficient~     monitoring has been identified as a particularly common cause of preventable and ameliorable~     ADE. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called~     for a process to accurately and completely reconcile medications across the continuum of~     care. Inpatient computerized medication reconciliation tools have shown great potential,~     but little is known about successful medication reconciliation strategies immediately~     post-discharge. One promising solution to outpatient medication reconciliation is the use of~     secure electronic communication (SEC) between patients, accessing their personal health~     record via a web portal, and providers within an electronic health record. Surveys have~     consistently found that patients want to communicate with their primary care providers via~     SEC, and SEC is rapidly becoming a standard feature in electronic health records. A~     SEC-based approach to outpatient medication reconciliation following hospital discharge has~     the potential to improve patient safety, but important questions must be addressed,~     including: What information needs to be included in the SEC? What elements of the SEC are~     essential to its design? How can SEC be best incorporated into the workflow of the primary~     care office practice? Will patients and physicians find this approach acceptable? To address~     these questions, we propose a one-year pilot study at VA Boston with the following specific~     aims:~      Aim 1: To evaluate the primary care environment's receptivity to secure electronic~     communication (SEC) for medication reconciliation and design a prototype SEC. We will use~     qualitative methods to characterize the primary care clinic environment - the physical space~     and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills~     of staff and, most importantly, the patients. Specific approaches will include in-depth~     interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a~     prototype SEC for medication reconciliation through a participatory design process,~     involving primary care clinicians, staff and patients working collaboratively with the~     research team, and to test the usability and acceptability of the prototype SEC among a~     sample of patients and primary care clinicians.~      Research and Development Plan: With extensive experience in designing and evaluating health~     care informatics innovations, we have assembled a multi-disciplinary team with expertise~     from primary care internal medicine, clinical informatics, health services research,~     qualitative research, clinical pharmacy, nursing and industrial engineering. This team will~     carry out a formative evaluation and develop a prototype of a secure electronic message to~     facilitate medication reconciliation following hospital discharge. The proposed CIMIT~     project will leverage the resources and expertise of the e-Health QUERI (a national VA~     program for innovation and evaluation of the VA's e-Health programs) at VA Boston and other~     participating VA facilities nationwide. The figure below shows a very rough~     conceptualization of the SEC that will guide the qualitative research and participatory~     design of the prototype. This project will lay the foundation for a future rigorous~     evaluation of this approach to medication reconciliation and improving patient safety.~   "
113983|NCT01564433|"~     Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and~     muscle coordination caused by damage to one or more areas of the brain, usually occurring~     during fetal development or infancy. One of the most disabling mobility impairments in CP is~     gait impairment, clinically characterized by reduced speed and endurance, as well as reduced~     step, stride length and toe clearance during gait.~      Recently, gait rehabilitation methods in patients with neurological impairment have relied~     on technological devices, which drive the patient's gait in a body-weight support condition~     and emphasize the beneficial role of repetitive practice. Early studies in gait~     rehabilitation in patients with CP were carried out by using partial body-weight support~     treadmill training (PBWSTT) and robotic-assisted treadmill therapy. Despite their potential,~     these technologies have practical limitations in their routine application.~      More recently, several studies have focused on the use of a new electromechanical gait~     trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have~     experienced a stroke. They have shown that training with this device may significantly~     improve gait performance. Despite the clinical impact of this new rehabilitative procedure,~     to date, no studies have been conducted on its use in children with CP.~   "
113984|NCT01564420|"~     The currently available data are insufficient to develop a model that achieves optimum~     morphine dose individualization at the postoperative period of coronary artery bypass~     grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could~     justify morphine consumption, drug plasma concentration and pain intensity during the~     postoperative period after CABG and evaluate the post operative pain.~   "
113985|NCT01564407|"~     The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the~     treatment of stable, restrictive scars in subjects who have suffered a burn injury.~     Evaluation will be achieved through regular assessment of adverse events, vital signs, blood~     work monitoring and laboratory analysis cellular properties of the scar through biopsy.~      The secondary objectives of this study are to evaluate improvement in symptoms of scars~     including reduced pain, discomfort and itching, improvement in mobility and daily function,~     improvement in appearance and scar texture.~   "
113986|NCT01564394|"~     Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly~     prostate cancer survivors.~      Describe participation, retention, and adherence rates and assess reasons for participation,~     attrition, and non-adherence.~      Identify effective recruitment and retention strategies. Ascertain participants' level of~     satisfaction and additional perceptions of the experimental and control interventions,~     perceived study burden, study design, and implementation.~      Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching~     exercises on fatigue, psychosocial outcomes, and health-related quality of life in~     preparation for a future R01 application for a larger, definitive randomized controlled~     trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life,~     and related psychosocial and health outcomes compared to those randomized to the non-aerobic~     stretching group.~   "
113987|NCT01564381|"~     The investigators hope to learn if resveratrol supplementation can be beneficial for the~     cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are~     interested in learning if a novel form of resveratrol, ResA, which is a mixture of~     resveratrol with amino acid, may have greater bioavailability and lead to greater~     improvement in vascular function, compared to standard resveratrol supplement.~   "
113988|NCT01564368|"~     RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI)~     and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating~     how well patients with breast cancer respond to treatment.~      PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in~     patients with breast cancer undergoing neoadjuvant chemotherapy.~   "
113989|NCT01564355|"~     Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It~     affects about 5 to 10% of Canadians. Patients suffer from congestion in the nose and~     sinuses, nasal discharge, pressure in the face, and a reduced sense of smell. This affects~     people's enjoyment of life. Medical management uses sprays or pills to treat these symptoms~     but for some patients sinus surgery is needed. This type of surgery is called endoscopic~     sinus surgery (ESS).~      There is no single correct approach to take care of patients after sinus surgery. Most~     experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus~     swelling and minimize complications related to scarring.~      Steroid-eluting nasal spacers are devices placed inside the sinus during surgery and~     slowly release topical steroids into the sinuses better than steroid sprays. These spacers~     have been shown to improve results following sinus surgery. When using these special~     spacers, there may no longer be a need for oral steroid pills following surgery. This~     would help to avoid potential side effects associated with these medications.~      The purpose of this study is to find out whether taking oral (systemic) steroid pills~     following sinus surgery is necessary to improve surgical results, now that steroid-eluting~     nasal spacers are commonly used during surgery.~   "
114003|NCT01564173|"~     The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at~     each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with~     impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic~     function will be assessed during a pacing protocol with a pressure catheter inserted in the~     LV.~   "
113990|NCT01564342|"~     This study is designed to compare the infection rates in wounds irrigated with sterile~     normal saline to those irrigated with chlorinated tap water. The hypothesis is that the~     wound infection rate subsequent to irrigation with tap water is not significantly different~     than the infection rate for wounds irrigated with sterile normal saline.~      Inclusion criteria are patients older than 1-year of age who present to the emergency~     department with a soft-tissue laceration requiring repair. Exclusion criteria include~     patients with any underlying immunocompromising illness, current use of antibiotics,~     puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine~     hours old.~      Patients are randomized to have their wounds irrigated either with tap water or sterile~     normal saline prior to closure, controlling for the volume and irrigation method used.~     Structured follow-up is completed at 48 hours and 30 days to determine the presence of~     infection.~      The primary outcome measure is the difference in wound infection rates between the two~     randomized groups.~   "
113991|NCT01564329|"~     To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time~     sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window~     period.~   "
113992|NCT01564316|"~     Using to method of Proteomics, for aims to conquer intractable disease, try to access~     variety experiment. Biomarker is necessary to develop new diagnosis method and target of~     treatment.~   "
113993|NCT01564303|"~     CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially~     effective and have not been approved by the Food and Drug Administration yet. The lack of~     effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new~     drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best~     of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on~     CIAKI prevention has not been examined, so far.~   "
113994|NCT01564290|"~     The purpose of this study is to determine the effect of probiotic yogurt in acute watery~     diarrhea in children. The investigators will compare the effect of two different probiotics~     products.~   "
113995|NCT01564277|"~     This randomized phase II trial studies how well giving rasburicase together with allopurinol~     works in treating patients with hematologic malignancies. Rasburicase may reduce the level~     of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more~     effective in treating hematologic malignancies when given together with or without~     allopurinol.~   "
113996|NCT01564264|"~     The purpose of this study is to determine if there is a difference between the lymphatic~     drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix~     and blue dye in the corpus of the uterus and to investigate the identification rate of~     sentinel nodes using this technique in patients with cancer of the uterus.~   "
113997|NCT01564251|"~     This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety,~     tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination~     with gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1,~     cohorts of participants will receive multiple ascending oral doses of GDC-0575 alone or in~     combination with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575~     orally in combination with intravenous gemcitabine at or below the maximum tolerated dose~     determined in Stage 1. Anticipated time on study treatment is until disease progression or~     unacceptable toxicity occurs, up to approximately 5 years.~   "
113998|NCT01564238|"~     Optimal calcium retention is important for building bone mass within the genetic potential,~     a key to reducing risk of osteoporosis later in life. Calcium retention is high during the~     rapid growth period. The investigators know that urinary calcium is affected by sodium~     intake but the investigators do not know the effects of sodium intake during the growth~     spurt or the differences in calcium retention between blacks and whites. Our hypothesis was~     that a high dietary sodium increases the calcium intakes required for optimal calcium~     retention in both black and white adolescent girls. The investigators tested calcium~     retention while girls consumed a low and high sodium diet during three week periods. The~     subjects were housed in a Purdue fraternity house during the summer and they were supervised~     at all times by trained staff. During the summer of 1999, subjects consumed diets with 2~     levels of dietary Na+ with a fixed diet low in calcium. On the next summer, they switched to~     a high calcium diet. Subjects collected fecal and urine daily for 20 days. Other~     measurements included daily body weight, blood pressure every other day, blood sample at the~     end of each session. Baseline measures included bone mass, self-assessment of pubertal~     development, a physical examination and diet history.~   "
113999|NCT01564225|"~     Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked~     Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure~     data for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected~     adults for this study provides a genetic match and biologic relevance to XLHED-affected~     neonates. Both males and females will be enrolled, providing safety experience with EDI200~     that will inform the planned neonate study as well as supportive data for potential future~     trials of antenatal EDI200 administration.~   "
114000|NCT01564212|"~     With approval of the IRB at the Cleveland Clinic and written informed consent, the~     investigators propose to study up to 20 healthy volunteers in the protocol below as this~     will allow for drop-outs. As the investigators believe that 10 volunteers will provide~     sufficient power to detect clinically-meaningful differences between laminar air flow~     treatments.~      The study has been designed to find out whether heat loss increases significantly in laminar~     air flow operating rooms. Furthermore the investigators will find out whether active warming~     minimizes this heat loss. Increased heat loss increases the amount of perioperative~     hypothermia. It has been shown that perioperative hypothermia is associated with severe~     complications such as an increased incidence of surgical wound infections. On the other hand~     laminar air flow is explicitly used to decrease air-borne infections. Our study results will~     help to optimize thermal management of orthopedic patients.~   "
114001|NCT01564199|"~     The objective of the study is to assess the extent to which the charcoal prevents the~     absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on~     comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).~   "
114005|NCT01564147|"~     Taking into account the recommendations of the Health Authority [1] and the application of~     patients' associations, we have structured a course of therapeutic education includes three~     stages for patients with rheumatoid arthritis and followed at Nantes University Hospital.~     Step 1: initial interview with a nurse patient education for diagnosis and education with~     the patient to choose three subjects from among 10 offered him problematic; Step 2:~     Orientation in an educational path that provides access to 6 months group workshops (3~     maximum) and / or interviews tailored to the three selected topics; Step 3: final interview~     with a nurse said therapeutic education formative assessment to take stock. The main~     objective of our work is to ensure that the patient finds it easier solutions to the three~     problematic topics him after 6 months of education after six months without treatment.~   "
114006|NCT01564134|"~     An interventional study will be performed in subjects aged 1-65 years old to evaluate~     effects of different doses of hepatitis B vaccines in low or non-response population.~   "
114007|NCT01564121|"~     The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the~     metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal~     radius.It is responsible for bony destruction in para-articular zone fracture and leading to~     the breakdown and destruction of the underlying joint.~      Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent~     of giant type cell of type osteoclastic responsible for bone resorption that accompanies~     these tumors and a contingent of lengthened cells fibroblast-like considered to be~     contingent tumor.~      The treatment is exclusively surgical; or by resection of the lesion which takes away tumour~     and its environment, solution which, if it prevents local recurrence, imposes an important~     bony and articular reconstruction, always limited and deteriorating rapidly over time in~     these young patients; or by curettage of lesion, by hollowing-out of the bone, creating a~     hole which it will be necessary to fill up by a bony grafting or a substitute of the bone~     (cement). This last solution, if it preserves a better function, exposes at risk of local~     recurrence,putting into play the prognosis of articulation near, most often the knee.Despite~     different local adjuvants treatments used during surgical operation, after having curetted~     the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25~     %) in literature.~      The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by~     a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is~     molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the~     recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,~     biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast.~     These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic~     cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental~     data of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours~     with giant cells but no clinical study assessed potential on the prevention of the local~     recurrence.~      The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on~     the prevention of the local recurrence of tumours with primary huge cells after surgical~     treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.~      Number of patients: 24~   "
114008|NCT01564108|"~     Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the~     treatment of a variety of retinal diseases. This study addresses a condition which affects a~     large number of our patients in whom the investigators face difficult management decisions.~     These patients with uveitis are severely disabled with visual loss related to cystoid~     macular oedema (CMO) and few options remain when standard treatment has either failed or is~     contraindicated.~      The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis~     is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is~     hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will~     be more effective in improving quality of life by reducing macular thickening and restoring~     visual function.~   "
114009|NCT01564095|"~     Utilisation of extended criteria donors due to critical organ shortage contributes to~     increased ischemia reperfusion injury as well as mortality following liver transplantation.~     Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using~     the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse.~     Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver~     transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic~     injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of~     the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on~     cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs~     according to Eurotransplant's definition of EDC grafts.~   "
114010|NCT01564082|"~     Patients presenting for elective surgery will be randomized to having the breathing tube~     inserted partly into the throat prior to GlideScope insertion, or having it inserted fully~     after GlideScope insertion.~   "
114011|NCT01564069|"~     Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer~     pain will report no improvement treatment efficacy when compared to patients with chronic~     pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that~     patients with intrathecal delivery systems for chronic non-cancer pain will report no~     improvement in treatment efficacy when compared to patients with chronic pain who are~     managed with non-opioid therapies.~   "
114012|NCT01564056|"~     The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall~     survival for elderly patients with breast cancer, in a sub group with a high risk of relapse~     according to Genomic Grade test.~   "
114013|NCT01564043|"~     Higher levels of physical activity are associated with better functional status, fewer~     hospital admissions, and lower mortality. The investigators studied the feasibility and~     safety of a novel program that combines a pedometer with a website to increase walking. This~     is a pilot study.~   "
114014|NCT01564030|"~     Solid food or fluid residue in the stomach is always a major concern when patients need~     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary~     aspiration of the stomach contents. This is especially important in emergency procedures,~     when a fasting period is not observed. The aspiration of the stomach contents into one's~     lungs can lead to serious complications (such as severe respiratory failure). Information~     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide~     whether or not it's safe to proceed, cancel or delay a surgical procedure.~   "
114015|NCT01564017|"~     As part of the registration plan of our products and after performing a Phase I study the~     present trial has been designed to compare the efficacy of 5 different doses of subcutaneous~     immunotherapy in depot presentation.~   "
114016|NCT01564004|"~     Does clinical hypnosis or neuro-linguistic programming improve the success rate of external~     cephalic version?~   "
114017|NCT01563991|"~     Subjects undergoing surgery on the small or large bowel will be randomized to one of 2~     groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact~     of this change on recovery after surgery.~   "
114021|NCT01563939|"~     Epidural analgesia for pain relief in labor may not be suitable for all patients, and~     intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative.~     The purpose of this study is to assess the effectiveness of two methods remifentanil~     administration in the form of either an infusion or PCA demand bolus (intravenous injection~     of a single dose over a short period of time). Currently, our hospital gives remifentanil by~     demand bolus, however it may be equally effective, with less side effects, to give the drug~     as an infusion.~   "
114022|NCT01563926|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid~     somatropin formulation in children with growth hormone deficiency.~   "
114023|NCT01563913|"~     The purpose of this research study is to measure the safety (side effects) of an Omega 3~     Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary~     movements) in Parkinson 's disease (PD).~   "
114024|NCT01563900|"~     Fatigue is a symptom present in 76 to 92% of people with multiple sclerosis (MS). Fatigue is~     usually described as an overwhelming sense of tiredness, lack of energy, and feeling of~     exhaustion which is different from sleepiness. Fatigue is also a symptom commonly seen in~     people with obstructive sleep apnea (OSA). The overall objective is to develop a~     non-pharmacological treatment for fatigue in MS. The objective of this study is to evaluate~     if treatment of OSA with continuous positive airway pressure (CPAP) improves fatigue in MS~     subjects with OSA and fatigue. This will be a small pilot randomized, double-blind,~     sham-controlled clinical trial; the control group will be treated with a sham-CPAP machine~     and intervention group will be treated with an auto-titration CPAP machine. The primary~     outcome measure will be improvement (decrease) in the Modified Fatigue Impact Scale from~     baseline. The duration of intervention will be 12 weeks to achieve a clinical response in~     the treatment group. After this intervention participants in both groups will be offered a~     referral to the sleep clinic of their preference for formal treatment as per standard of~     care.~   "
114025|NCT01563887|"~     This study will recruit drivers with Type 1 diabetes from across the U.S. and assign them to~     four groups based on their presumed risk level- routine care low risk, routine care high~     risk, or to one of two Internet interventions focused on reducing hypoglycemia driving. All~     subjects will be followed for two years to determine whether and which intervention was most~     effective at reducing hypoglycemia related driving collisions.~   "
114026|NCT01563874|"~     BACKGROUND:~      Lymphomas are comprised of a diversity of tumors with different pathologic and clinical~     features. While distinct differences in gene expression profiles have been elucidated in~     different lymphomas, there has been inconsistent correlation with the few published~     proteomic studies.~      Greater insights into the biology of lymphomas may be achieved by integrating current~     genomic information with additional studies focused on the interrelationships in tumors of~     the patterns of chromatin protein expression, chromatin protein modification, and RNA~     expression profiling (both within bulk tumor and within specific microscopic tumor niches~     accessible by microdissection and cell sorting approaches).~      OBJECTIVES:~      The goals of this protocol are to identify the global levels of all histones (including~     variant histones) and non-histone chromosomal proteins, and to measure the relative levels~     of most known covalent modifications on histone and non-histone chromosomal proteins.~      For a limited number of cases illustrative of selected pathological entities, we propose to~     map the genome-wide distribution of those modifications judged to be biochemically~     instructive.~      ELIGIBILITY:~      This work will involve the analysis of a broad panel of lymphoma and lymphoid samples, which~     were previously procured under multiple protocols at the NIH, and for which there is excess~     tissue available for research. We also request permission to extend this analysis to surplus~     materials to be accrued under existing protocols, upon completion of all superseding~     diagnostic tests and medical/scientific studies. The criteria for inclusion in this study~     are subsumed under the enveloping protocols. The number of cases to be included is dependent~     upon the size of these protocols; because statistical significance improves with increasing~     numbers. We hope to include up to 300 cases.~      DESIGN:~      Lysates from surplus samples will be prepared and arrayed onto microarrays.~      These arrays will be probed with panels of protein and modification specific antibodies.~      The antibody reactivity will be quantified and samples will be subjected to statistical~     analysis, especially hierarchical clustering to correlate patterns of reactivity with~     clinical and histological features.~      Representative cases for which sufficient surplus tissue remains will be subjected to~     ChIP-Seq to map the distribution of modifications across the genome.~   "
114027|NCT01563861|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors find better ways to treat cancer.~      PURPOSE: This research trial studies genes in samples from patients with limited and~     advanced diffuse large B-cell lymphoma.~   "
114028|NCT01563848|"~     The investigators hypothesized that revealing the incidence of AF following RFA of the CTI~     and cryoablation PVI reduces incidence of AF following RFA of the CTI.~   "
114029|NCT01563835|"~     There has been very little investigation into the management of pain from 2nd trimester~     termination of pregnancy or unexpected fetal loss. The standard of practice in North America~     is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as~     fentanyl. The goal of this study is to compare the quality of recovery after termination of~     pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard~     of care for live births. The study will be conducted as a randomized controlled trial.~   "
114030|NCT01563822|"~     Background:~      Traditionally during ovum pick-up in ICSI, we aspirate the follicles for oocyte retrieval~     but unfortunately we don't make use of the follicular fluid (FF) and we discard it in spite~     of the fact that this does not happen in nature. The fallopian tube picks-up the FF with the~     oocyte during ovulation. As this fluid contains stem cell factor and C-Kit receptor~     responsible for implantation and IGF responsible for endometrial growth and TGF that~     improves implantation. That's why flushing the endometrial cavity with FF after ovum pick-up~     might improve endometrial receptivity and implantation rates; the limiting step in ICSI.~      Patients and Methods:~      100 patients attending kasr El-Aini IVF center preparing for ICSI cycles are randomized into~     two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular~     fluid surrounding mature oocytes through an IUI catheter is done after ovum pick-up While in~     the control group, no flushing of the endometrial cavity with FF is done. The implantation~     rates and pregnancy rates in both groups will be assessed.~   "
114031|NCT01563809|"~     Basing the investigators study on the evidence that basal serum androgens decrease with age,~     the investigators hypothesize that women with serum androgens below a certain level could be~     the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The~     objective of the present study is to explore the relationship between basal serum androgen~     levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.~   "
114032|NCT01563796|"~     The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in~     the urine of patients suspected of having bladder cancer. The measurement of urine DEK~     protein, relative to an established cut-off, is correlated with the presence or absence of~     bladder cancer.~   "
114034|NCT01563770|"~     Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional~     Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and~     myocardial infarction. Several preclinical studies point towards promising effects of~     Danshen on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia~     and hypertension.~      Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract~     (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on~     hypertension. Further objectives are to determine its effect on endothelial function,~     oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.~   "
114035|NCT01563757|"~     The investigators are studying what causes Plastic Bronchitis and Protein Losing~     Enteropathy. The investigators think that these problems are from too much of two small~     proteins called Vasoactive Intestinal Peptide (VIP) and Substance P. VIP and Substance P are~     important proteins in the body that normally tell the body to make small amounts of fluid~     and they help the intestines work. Normally, VIP and Substance P are made in the intestines~     and then destroyed in the lungs after they do their normal work. The investigators think~     that kids who have Plastic Bronchitis and/or Protein Losing Enteropathy who also had the~     Fontan surgery might have too much VIP and Substance P in their bodies. The investigators~     think this causes too much fluid to go in the lungs and too much protein in the intestines.~   "
114036|NCT01563744|"~     Adequate bowel preparation is of critical importance for colonoscopy. Particularly among~     hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient~     intolerance to prescribed laxative regimen, elderly population, and co-existing conditions~     that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel~     preparation for colonoscopy in hospitalized patients would likely improve patient care and~     reduce hospital costs. The purpose of this study is to determine if administering a portion~     of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized~     patients.~   "
114037|NCT01563731|"~     Stroke is one of the major causes not only of mortality, but of disease burden worldwide,~     because of residual disability and cognitive decline. Although blood pressure lowering has~     been clearly shown to be the most effective means for primary and secondary prevention of~     stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to~     optimize prevention results are unknown, and whether SBP levels lower than those usually~     recommended are accompanied by further or reduced benefits is undecided yet. Likewise, while~     low-density lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be~     associated with primary and secondary stroke prevention, whether more intense lowering is or~     is not of further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial~     (ESH-CHL-SHOT) is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to~     test the hypothesis that in elderly patients at high risk of recurrent stroke (previous~     recent stroke or TIA) antihypertensive treatment programs aimed at reducing SBP to the~     usually recommended values (< 145 to 135 mmHg), to a lower goal (< 135 to 125 mmHg) or to~     even lower values (< 125 mmHg) will result in progressively greater reductions in recurrent~     stroke, incidence of cardiovascular outcomes and cognitive decline. Parallely, the~     preventive efficacy of more and less intense LDL-C reductions will be tested on the same~     outcomes.~   "
114038|NCT01563718|"~     Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction~     and it has been reported to be clinically effective in parolee populations although it is~     rarely used. Recently a depot formulation with one-month duration has received FDA approval~     for the treatment of alcoholism and opiate dependence. This means that rather than having to~     take medication daily, individuals can receive one injection that lasts for approximately 30~     days. The purpose of this study is to determine whether this monthly injection of naltrexone~     is practical and useful in the prevention of relapse to opioids and re-incarceration when~     administered to inmates prior to release from prison. The investigators will also monitor~     HIV risk behaviors to determine whether the intervention reduces risky behaviors associated~     with intravenous drug abuse and the spread of viruses such as HIV and hepatitis C.~     Volunteers will be randomized to receive an injection of depot naltrexone prior to release~     from prison or to contact study personnel in the community following release. Participants~     assigned to receive naltrexone in prison will receive 1 injection in prison, and 5~     additional monthly injections for 5 months upon release. Participants assigned to contact~     study personnel upon release will receive all 6 injections in the community at RIH after~     their release from the ACI. Patients in both groups will be given identical follow up~     monthly for six months including measures of opiate use by self-report, and urine tests. An~     additional scheduled urine test will take place each month between monthly visits. There~     will also be a 12-month follow-up period for participants in both groups, which will consist~     of 2 visits, spaced 6 months apart, meaning that participants will be enrolled in the study~     for a total of about 18 months. All participants will be asked to complete brief~     questionnaires at follow-up visits to assess things such as services received, drug use, and~     depression.~   "
114039|NCT01563705|"~     The aim of this study is to improve knowledge of natural history and methods of monitoring~     the evolution of Glycogen storage disease type III regarding the muscle and to study the~     prospective approach of large series of patients, and using the same protocol for the follow~     up of the children and adults.~   "
114040|NCT01563692|"~     Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most~     important cause of severe respiratory illness in infants and young children, a major cause~     of infantile bronchiolitis and is the most frequent cause of hospitalization of infants and~     young children in industrialized countries. Severe RSV infection early in life is associated~     with an increased risk of subsequent recurrent wheezing and asthma. There are few~     population-based estimates of the incidence of RSV disease from developing countries, but~     the existing data clearly indicates that the virus accounts for a high proportion of Acute~     Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest~     that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar~     to that in industrialized countries, and WHO has estimated the global RSV disease burden at~     64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly~     and immune-compromised adults, and the burden of RSV disease in the elderly is comparable to~     that of seasonal influenza. The economic impact of RSV-related disease in adults estimated~     to be greater than that of influenza in relation to numbers of days lost from work.~      The development of a safe and effective vaccine against RSV would benefit greatly from data~     on the immune responses in healthy adults naturally exposed to the virus. RSV infection has~     been shown to increase and induce short-lived circulating antibody secreting cells and~     produce an increase in the RSV specific antibody titres but very limited data is available~     on the cellular immune responses induced by RSV during natural infection in healthy adults.~     The existence of cell mediated immune response against RSV in humans has been described but~     characterization of this response remains poor and simultaneous analysis of several~     immunological parameters have not been attempted in an RSV exposed population before.~   "
114041|NCT01563679|"~     This is a study involving patients with cancer who are referred by their treating physician~     for percutaneous locoregional therapies.~      Patient's clinical and radiology findings, pathology findings, survival, treatment~     responses, and complications after their locoregional therapy will be studied.~   "
114129|NCT01562327|"~     This multi-center, observational study will evaluate the clinical practice patterns,~     efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to~     severe rheumatoid arthritis. Data will be collected from each eligible participant initiated~     on RoActemra/Actemra treatment by their treating physician according to local label for 6~     months from start of treatment.~   "
114042|NCT01563653|"~     The investigators hypothesize that an innovative test device simulating transvaginal tape~     support will increase the performance and reproducibility of the diagnosis of urethral~     hypermobility before surgery for urinary incontinence.~      The main objective of this study is to compare two prognostic tests in their ability to~     predict the success (or failure) of the implementation of a suburethral TVT (tension-free~     vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in~     women. The Q-tip test (test mentioned in the French and international recommendations) is~     compared to test a new test (clip strip).~   "
114043|NCT01563640|"~     This is a randomised controlled trial that will be conducted in eastern Thailand in a group~     of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms~     will be commercially treated to ensure consistent high quality of insecticide impregnation~     with permethrin. A double-blind randomised cross-over trial at the school level will cover~     two dengue transmission seasons.~   "
114044|NCT01563627|"~     Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug~     resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies~     with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where~     feasible, surgical removal of the home is the best therapeutic outcome.~      Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical~     and experimental studies have shown that dysfunction of the blood-brain barrier (BBB)~     contributes to epileptogenesis and drug resistance. It is now recognized that cytokines~     exacerbate the excitability and permeability of the BBB, which was recently confirmed by~     studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have~     described an association between pathological angiogenesis and BBB permeability in the~     tissue of patients with excision of drug-resistant TLE. With experimental models, it was~     revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the~     BBB.~      The investigators hypothesis is that the identification of factors involved in BBB~     permeability may designate potential targets for drug-resistant partial epilepsy.~   "
114045|NCT01563614|"~     The purpose of this trial is to test the safety and tolerance of the combination therapy~     with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from~     malignant melanoma.~   "
114046|NCT01563601|"~     This is a randomized, multi-center, open-label study of approximately 24 months duration~     (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in~     combination with carboplatin and etoposide versus carboplatin and etoposide alone in~     chemotherapy-naive patients with extensive-stage small cell lung cancer.~   "
114047|NCT01563588|"~     Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them~     are able to find back to their initial weight after all treatments are finished. Other~     studies have shown that overweight at diagnosis was associated to a twice higher risk of~     relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse.~     In western countries, 75% of BCP have insufficient physical activity. Dietary and activity~     programs seem to be able to significantly reduce the mortality risk after breast cancer.~      The investigators performed a prospective randomized trial consisting in dietary counseling,~     physical training and physiotherapy in hydrothermal centers. Intervention were delivered in~     small group session lasting 12 days. SPA cares were offered to patients. Patients in the~     control group also received dietary counseling given by a dietetician inside anticancer~     hospital, and were asked to perform more physical activities. Main endpoints of the trial~     addressed quality of life (SF36) one year after inclusion, weight reduction,~     anxiety/depression (HAD), sleep quality and long term compliance to instructions. An~     economic study was associated to the protocol, for volunteers only.~   "
114048|NCT01563575|"~     The project's background is the notion that patient centred clinical health promotion has~     been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO~     describes health promotion as a key dimension of quality in hospitals, and the organization~     has developed standards on the topic in order to help hospital management and staff members~     to assess and improve the quality of health care and thereby achieve better health for~     patients, staff, and community. Even so, however, health promotion is still a very implicit~     part of nearly all quality standards on hospitals. Moreover, assessing hospitals~     departments' health promotion performance is still quite an unexplored area. On this basis,~     this project will test a new recognition process that uses the relevant WHO-HPH tools and~     standards to assess performance, by way of explicit documentation and evaluation of clinical~     health promotion activity. The project is deigned as a RCT, with a control group that~     undergoes the recognition process immediately and a control group that continue usual~     clinical routine. Then, after one year, the control group also begins the recognition~     process (= delayed start), while the Intervention group (=immediate-start) continues with~     the recognition process. Doing this allows for a great array of measurements, and hopefully~     the project will then show whether the recognition process really benefits implementation of~     health promotion in hospitals and health services, and also, if this really generates better~     health gains for patients and staff. The outcome measurements will be frequency of health~     promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition,~     and physical activity to patients in need. Such services could for instance be motivational~     counselling and brief interventions, as well as intervention, rehabilitation and after~     treatment. Physical, mental, and social health status among patients and staff will be~     measured by short form (SF36).~   "
114049|NCT01563562|"~     The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl~     following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate,~     and severe hepatic impairment, as compared to healthy volunteers.~   "
114050|NCT01563536|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and~     antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)~     administered as two-day monotherapy followed by ABT-267 in combination therapy with other~     direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also~     known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)~     infection without cirrhosis.~   "
114051|NCT01563341|"~     Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus~     potentially improve cognitive function in patients with Parkinsons disease.~   "
114062|NCT01563198|"~     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of~     claustrophobia or inability to hold still. Training staff working in MRI facilities to~     provide Comfort TalkTM promises to enable patients to complete and obtain high quality~     imaging without medication, which will increase comfort and reduce sedation risks for the~     patients, and increase efficiency and reduce loss of revenue for the facilities.~   "
114142|NCT01562158|"~     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate~     the efficacy of placebo and activated recombinant human factor VII in patients having~     undergone allogeneic or autologous stem cell transplantation.~   "
114052|NCT01563328|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of human immunodeficiency virus (HIV) infection.~     Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is~     expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and~     Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently~     approved by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have~     rapidly been adopted to standard of care in combination with pegylated interferon and~     ribavarin. This is a single-center, open-label, two-cohort, two-period, one-way, study in~     healthy adult subjects. A total of approximately 32 subjects will be enrolled, in order to~     obtain 24 evaluable subjects (12 per cohort). In the first treatment period, all subjects~     will receive DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will~     receive DTG 50 mg once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750~     mg q8h (treatment C) for 10 days. There will be no washout between treatments. Safety~     evaluations and serial PK samples will be collected during each treatment period.~      Subjects will have a screening visit within 30 days prior to the first dose of study drug,~     two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.~      This study will be conducted at one center in the US, with healthy adult male and female~     subjects.~   "
114053|NCT01563315|"~     The purpose of this study is to determine the etiology of community-acquired pneumonia, to~     assess risk factors and to investigate potential prognostic biomarkers of serious disease~     and fatal outcome.~   "
114054|NCT01563302|"~     This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of~     patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas~     will be enrolled into the dose-expansion cohort.~   "
114055|NCT01563289|"~     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients~     with ankle injuries.~   "
114056|NCT01563276|"~     The purpose of this study is to better understand why individuals with Progressive~     Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction~     in individuals with PSP may provide us with important early diagnostic tools, allowing for~     earlier identification of mobility problems and to better evaluate medical therapies aimed~     at improving motor disability.~      The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All~     subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for~     an initial screening visit. They will meet with the primary investigator to conduct a brief~     interview and physical examination. In addition, they will be asked to answer questions~     regarding current and past medical illness, how often they fall and what kinds of~     medications they are on.~      Subjects who agree to participate will come to the Oregon Clinical and Translational~     Research Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or~     sit on a movable platform with eyes open or closed. Prior to standing on the platform, the~     investigators will place 6 small sensors on body which are held in place by velcro straps~     (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or~     slide) while subjects try to keep their balance. During all of the balance tests described~     above, body movements will be recorded from the sensors on the subjects' body. This data is~     directly recorded by a computer and analyzed to help us gain better understanding of the~     subjects' posture and their ability to remain up right.~   "
114057|NCT01563263|"~     This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase~     II/III study. The study population consists of male or female intensive care unit (ICU)~     patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and~     80 years.~   "
114058|NCT01563250|"~     By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the~     investigators can effectively reduce ED wait times and ED length of stay by decreasing~     overall hospital admissions and telemetry admissions. In addition, the investigators~     hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by~     increasing the patient to health care provider ratio.~   "
114059|NCT01563237|"~     To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma~     that is inadequately controlled on maximum tolerated medical therapy with intraocular~     pressure ≥ 18 mm Hg and ≤ 40 mm Hg~   "
114060|NCT01563224|"~     There are several developing lines of evidence suggesting that brain receptors called GABA-B~     receptors play a significant role in addiction and its treatment. The investigators wish to~     examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of~     the investigators MRC programme of research in neurotransmitters in alcohol and opiate~     addiction (NOAA). In this present study the investigators will give 2 different single doses~     of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects~     GABA-B receptors in the central nervous system and is licensed for the treatment of~     spasticity in people with eg spinal injuries; the investigators are interested in its~     effects on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye~     movements, blood pressure and heart rate, motor co-ordination and subjective effects and~     also blood levels of the drug in the investigators volunteers before and at intervals after~     dosing. The investigators will use a double-blind randomised design to minimise expectation~     effects. The study will provide information on timing and magnitude of effects of baclofen~     on brain function in healthy subjects so that the investigators can optimise selection and~     timing of functional measures in future studies of addicts.~   "
114061|NCT01563211|"~     Patients with breast cancer, who are treated with curative intent, have a combination of~     surgery (excision of the tumor) and a course of medical therapy (chemotherapy or endocrine~     treatment). Both treatments are associated with significant side effects. Chemotherapy is~     associated with nausea, vomiting, hair loss and bone marrow suppression, whereas endocrine~     therapy is associated with arthritis and menopausal symptoms. Patients taking either~     chemotherapy or endocrine treatment may experience a range of side effects. The range and~     severity of side effects experienced vary from patient to patient. Little or nothing is~     known about the reason for this difference.~      The aim of the investigators proposal is to develop a pretreatment test to identify patients~     who are likely to undergo moderate to severe side effects, and therefore help doctors and~     patients plan and optimize medical therapy. The pretreatment test will be based on~     identifying a metabolic profile which can differentiate those patients who are likely to~     have severe or moderate side effects from those with either no or mild side effects. To do~     this, the investigators will take urine and blood samples from patients before and after the~     administration of endocrine treatment or chemotherapy and generate metabolic profiles.~      Furthermore, the investigators aim to gain an understanding into why side effects~     experienced between different patients are so variable. To do this the investigators plan to~     perform cytokine analysis, targeted genetic analysis and pharmaokinetic analysis on blood~     sample collected from patients before and after treatment has commenced. Patients who have~     planned surgical excision of tumor and are recommended to receive medical therapy before or~     after surgery would be invited to join the study. Each patient will be required to make~     additional visits to the hospital to complete questionnaires regarding side effects~     experienced and for sample (urine and blood) collection. The investigators plan to recruit~     168 patients.~   "
114063|NCT01563185|"~     The primary objective of this Phase 4, multi-center, open-label study is to evaluate the~     safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10~     years to 16 years, 11 months, treated up to 24 weeks.~      The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients~     and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11~     months receiving DUEXIS for up to 24 weeks.~   "
114064|NCT01563172|"~     This study will evaluate and compare the effect of the amount of toothpaste used and~     brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR)~     and enamel fluoride uptake (EFU).~   "
114065|NCT01563159|"~     This study aims to confirm the statistically significant decline in rotavirus related and in~     acute gastro-enteritis (AGE) related hospital admissions that was observed in 11~     participating hospitals, after the introduction of RV vaccines in Belgium in 2006.~   "
114066|NCT01563146|"~     This study aims to collect data and assess the number of rotavirus related hospitalizations~     in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis~     over time.~   "
114067|NCT01563133|"~     This study focuses on three different lesions: pancreatic cysts, lymph nodes near the~     gastrointestinal tract and pancreatic masses.~      On one hand, the results obtained during previous studies are more advanced for the~     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser~     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have~     already been performed, and an interpretation criteria classification exists. On the other~     hand, results for pancreatic masses and Lymph nodes are less developed.~      The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on~     pancreatic masses and lymph nodes.~        1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and~          tissue sampling allows better characterization of pancreatic cysts and improves~          appropriate therapeutic decision-making.~           For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts~          could impact patient management by :~             -  Ruling out malignancy for patients with benign appearing nCLE images.~             -  Characterizing more malignant tumors in the pancreas.~        2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo~          imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during~          EUS-FNA procedures is feasible and that descriptive criteria can be defined to further~          differentiate the different types of lesions.~   "
114068|NCT01563120|"~     Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards~     include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG~     recommend glucose control in order to reduce the incidence of hyperglycemia induced~     complications. Glucose control can be achieved using diet and life style changes. Insulin is~     initiated in women who fail to obtain glucose control with diet alone. During the past 11~     years oral hypoglycemic drugs have been tested and proven to be efficacious and safe.~      Objectives~        1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of~          women diagnosed with GDM~        2. To evaluate the improvement in glycemic control after the addition of a second oral~          hypoglycemic drug after failure of the first~      Hypothesis GDM is one of the major conditions contributing to obstetrical complications and~     prenatal morbidity. Improving glycemic control, by means of improving compliance and patient~     satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and~     have positive long term health implications.~      Study design Prospective, randomized, open label~      Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM~     will be defined by a pathological OGTT (according to Carpenter and Coustan criteria)~     performed at or after 13 weeks of gestation.~      Study period From recruitment until discharge of the newborn baby after delivery~      Study protocol Women will be randomized at recruitment. Demographic and obstetrical data~     will be collected. Average glucose levels during the previous two weeks, estimated fetal~     weight and amniotic fluid index, and lab exams reflecting glycemic control will be noted.~     Women will provide daily glucose levels via fax or mail once a week. Glycemic control will~     be evaluated by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a~     7th measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a~     sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol~     after 38 w of gestation will be according to our ward's protocol. The study was approved by~     the local Helsinki committee.~      Time table Duration: two years~   "
114069|NCT01563107|"~     Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma~     volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma~     volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be~     impaired in POTS and may respond inappropriately to changes in dietary sodium. The~     investigators propose that the changes in urinary sodium and dopamine excretion caused by~     consuming low-sodium and high-sodium diets will be different between patients with POTS and~     healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary~     sodium level appropriately influence sodium excretion in POTS; (2) whether changes in~     dietary sodium level appropriately influence DA excretion in POTS; (3) whether a high~     dietary sodium level appropriately expands plasma volume in POTS; and (4) whether patients~     with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a~     high dietary sodium level.~   "
114070|NCT01563094|"~     This is a prospective observational trial of healthy postpartum women to investigate changes~     in bone density and markers of bone turnover during lactation. The study hypothesis is that~     women who breast-feed 5 months or more will lose bone density and subsequently regain the~     bone density after weaning. This study seeks to define determinants of the regain in bone~     density.~   "
114071|NCT01563081|"~     To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients~     aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the~     skin diseases.~   "
114072|NCT01563068|"~     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects~     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for~     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a~     multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their~     primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas~     of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14~     days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of~     calcipotriene will be evaluated~   "
114073|NCT01563055|"~     This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic~     profile of ofatumumab in combination with chlorambucil in Japanese patients with previously~     untreated Chronic Lymphocytic Leukemia (CLL).~   "
114074|NCT01563042|"~     An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics,~     immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in~     healthy male subjects~   "
114075|NCT01563029|"~     This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,~     parallel-group, placebo and active controlled study in children aged 5-11 years with~     persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of~     the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period~     during which time they will continue their current medications. Visit 2 will occur two weeks~     into the run-in period to allow a review of compliance with daily diary and run-in~     medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility~     criteria who remain uncontrolled despite baseline therapy will be stratified based on pre~     screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to~     the treatment phase of the study where they will receive one of five treatments for 12~     weeks. Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a~     total of 115 randomized/evaluable subjects per treatment arm. Subjects will attend~     on-treatment visits at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up~     contact will be performed one week after completing study medication. All subjects must~     attempt spirometry measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine~     collection for urinary cortisol and creatinine excretion will be performed prior to~     randomization at Visit 2 and within 7 days prior to Visit 7. All subjects must perform PEF~     daily between visits 1 and 7. The primary endpoint will be change from baseline in pre-dose~     (i.e. dosing trough) PM PEF from patient hand held electronic daily diary at Endpoint~     (Endpoint is defined as the mean over the last 7 days of treatment). Safety assessments~     include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol,~     and vital signs.~   "
114076|NCT01563016|"~     The research aims to investigate the relationship between self-control ability and blood~     glucose level in schizophrenic patients. The main purpose of the present study is to explore~     whether the close relationship of blood glucose and self-regulatory strength observed in~     healthy individuals, is applicable to schizophrenic patients. More specifically, the current~     study aims~        -  to investigate whether the exertion of self-control reduces blood glucose,~        -  to examine whether low level of blood glucose deteriorates subsequent self-control~          performances~        -  to examine whether restoring the glucose level eliminates these impairments, in~          schizophrenic patients.~   "
114077|NCT01563003|"~     Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this~     study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in~     50 adolescents versus other available treatment options.~   "
114078|NCT01562990|"~     The purpose of this study is to determine the recommended dose of CMC544 administered in~     combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and~     oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of~     this combination will be evaluated preliminarily in patients with DLBCL in relapse or~     refractory, who are no candidates for autologous transplant.~   "
114079|NCT01562977|"~     The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin~     and dexametasone (R-GemOx) chemotherapy schedule.~   "
114080|NCT01562964|"~     This study will investigate whether clinical hypnotherapy can effectively treat chest pain~     symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest~     pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal'~     coronary arteries is found in 25% of patients undergoing investigation of chest pain using~     coronary angiography (when dye is injected into the coronary arteries whilst xray pictures~     are taken), and the majority of these patients are postmenopausal women. Often there is no~     obvious physical cause. Despite symptoms being treated using conventional drugs, and life~     expectancy is not affected, many patients continue to suffer from debilitating chest pain~     symptoms, frequently resulting in visits to hospital, increased psychological illness and~     poor quality of life. The investigators are interested in finding ways of improving not only~     chest pain symptoms but also psychological wellbeing and quality of life in these patients.~     Previous studies of ours have found improvement in these patients after taking part in a~     support group, and using a relaxation technique called Autogenic training. Recently the~     investigators conducted a pilot study which showed a favourable effect of hypnotherapy on~     physical ability, well-being and quality of life. The investigators would now like to extend~     this study, performing a larger randomised, controlled trial. The investigators hypothesise~     that hypnotherapy will beneficially affect symptoms and quality of life in patients with~     cardiac Syndrome X.~   "
114081|NCT01562951|"~     This study will test that individualized treatment in patients with Crohn's Disease in~     remission or mild clinical activity under immunosuppressants may improve prognosis, rather~     than just treating flares.~   "
114082|NCT01562938|"~     This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult~     subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive~     MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will~     be followed for safety from the time of Informed Consent through 360 days post dose.~   "
114083|NCT01562925|"~     Patients with impaired renal function are at elevated risk for development of~     contrast-medium induced acute kidney injury (CI-AKI). CI-AKI is associated with increased~     risk for cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are~     needed.~      The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine~     consumption prior to contrast-medium use is effective in CI-AKI prevention.~      Consecutive patients with impaired renal function undergoing elective coronary angiography~     will be assigned in one of four treatment arms: a. control patients receiving standard care~     b. patients receiving standard care plus red wine c. patients receiving standard care plus~     white wine d. patients receiving standard care plus beer This study will give important~     answers on how to prevent CI-AKI in patients with impaired renal function undergoing~     contrast media exposure.~   "
114084|NCT01562912|"~     Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF~     is associated with increased risk of stroke, heart failure, and even mortality1. AF can also~     cause debilitating symptoms and adversely affect a patient's quality of life and functional~     status. These are amongst several reasons why a strategy of sinus rhythm may be pursued over~     a strategy of allowing AF to persist2-6.~      Percutaneous catheter ablation has emerged as an effective alternative to antiarrhythmic~     drugs (AAD) for maintaining sinus rhythm7. The cornerstone of AF ablation procedures today~     is electrical disconnection or isolation of the pulmonary vein (PV) antra from the rest of~     the left atrium (LA)8-13. In experienced hands, the success rate of PV isolation off AAD is~     about 80-90% in patients with paroxysmal AF, but repeat procedures are required in up to 40%~     of patients14-18. Thus, after one ablation, the success rate may only be 50-70% off drugs.~      Current standard ablation procedures for PV antral isolation employ mapping systems with~     which reconstructions of the LA and PV anatomy can be created. Visualization may be~     supplemented by integration of CT or MRI images and/or intracardiac echocardiography.~     Robotic navigation systems have also been employed to assist in ablation. The result is that~     ablation technology has become very complex and costly. Furthermore, all of these~     technologies are based on a single point unipolar radiofrequency (RF) ablation catheter~     where lesions are created point-by-point around the PVs to eventually obtain electrical~     isolation. This results in a lengthy procedure, often more than 4 hours, which requires a~     high degree of operator skill. Creation of contiguous, transmural lesions is also~     challenging with standard single-point RF.~      Recently, a novel multipolar catheter ablation system has been evaluated for achieving PV~     isolation (PVAC catheter, Ablation Frontiers, Medtronic Inc., Minneapolis, MN). Based on an~     over-the-wire circular mapping and ablation design, the catheter can be advanced into the PV~     antrum, and multiple lesions around the circumference of the catheter can be delivered~     simultaneously using duty-cycled unipolar and bipolar RF energy. In early reports, the~     system can achieve complete PV isolation with reduced fluoroscopy and procedural times and~     uses lower powers to achieve more reliable lesion sets19-21. Long-term efficacy also seems~     comparable to standard RF ablation22,23.~      This novel technology has the potential to broaden the application of AF ablation, by making~     the procedures less time-consuming and less complex without compromising on procedural~     efficacy. However, published data on outcomes related to use of PVAC technology are limited~     to studies with relatively small sample sizes ranging from 12 to 102 patients20-25. Data has~     been restricted to experiences from a small number of European centers performing moderate~     numbers of PVAC procedures and there is no prospective, multicenter data. The investigators~     therefore know little about the efficiency of PVAC procedures, which in turn, may allow for~     an assessment of the cost-effectiveness of using this technology.~   "
114097|NCT01562743|"~     The aims of the trial are to assess the safety and the efficacy of SPM 962 following~     once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese~     patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum~     treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week,~     double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003).~     The trial is also for an exploratory investigation of incidence of augmentation, the most~     problematic complications in dopaminergic treatment.~   "
114098|NCT01562730|"~     Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict~     myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography~     findings~   "
114099|NCT01562717|"~     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients~     with ankle injuries.~   "
114085|NCT01562899|"~     This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part~     is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the~     combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the~     clinical efficacy and to further assess the safety of the combination in selected patient~     populations. The dose escalation part of the study will be guided by a Bayesian Logistic~     Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose~     escalation part.~      Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess~     efficacy of the combination as well as to better understand the safety, tolerability, PK,~     antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist~     of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will~     consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm~     3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.~      Patients will be treated until progression of disease, unacceptable toxicity develops, or~     withdrawal of informed consent, whichever occurs first. All patients will be followed up -~     at minimum patients must complete the safety follow-up assessments 30 days after the last~     dose of the study treatment.~   "
114086|NCT01562886|"~     This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral~     therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of~     the study the participants will attend clinic where they will have blood collected followed~     by a lumbar puncture where cerebrospinal fluid will be collected to measure drug~     concentration. The participants will then restart their original regime with nevirapine.~   "
114087|NCT01562873|"~     This research study is a Phase II clinical trial. Phase II trials test the effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that drug is still being studied and that research doctors are~     trying to find out more about it-such as the safest dose to use, the side effects it may~     cause, and if the drug is effective for treating different types of cancer. It also means~     that the FDA has not approved ruxolitinib for your type of cancer.~      Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is~     thought that this pathway might be important in certain types of breast cancer, and that~     blocking this pathway might lead to anti-cancer effects. This study is testing the effects~     of ruxolitinib in patients with breast cancer.~   "
114088|NCT01562860|"~     The investigators are comparing two standard of care procedures which can be performed at~     the same time, or sequentially. The hypothesis being tested is whether simultaneous release~     of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of~     symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of~     both carpal tunnel and pronator Teres syndromes are present.~   "
114089|NCT01562847|"~     The purposes of this study are to investigate expression and frequency of ABL point~     mutations, a major cause of resistance in imatinib failed CML Asian patients and to find~     causes of Asian-specific resistance to cancer-targeting therapies through a prospective~     investigation of dynamics of point mutations and expression of new point mutations during~     nilotinib treatment.~   "
114090|NCT01562834|"~     This trial is conducted in Europe. The aim of this trial is to assess the effect of~     somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients~     with a growth hormone deficiency.~   "
114091|NCT01562821|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic~     efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to~     undergo partial hepatectomy due to liver cancer or benign tumours.~   "
114092|NCT01562808|"~     Dopamine receptor occupancy and brain metabolism were measured using positron emission~     tomography after the administration of aripiprazole. Working memory performance was also~     measured using N-back task.~      The investigators explored the relationship between changes in brain metabolism and working~     memory performance.~   "
114093|NCT01562795|"~     This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have~     therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the~     two nonsteroid anti-inflammatory drops with topical corticosteroids.~   "
114094|NCT01562782|"~     The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in~     response to the ingestion of a mixture of glucose and fructose is greater in South Asians~     compared to controls (Caucasians).~   "
114095|NCT01562769|"~     Application of isolation (=contact precautions) in hospitalized patients is recommended when~     patient is colonized (or infected) by micro-organism known for its outbreak capacity or high~     pathogenicity. It allows the reinforcement of universal precautions (=standard precautions)~     in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy~     of this measure is questioned and its impact on patient care seems deleterious.~      In a particular context of Infectious Disease Unit, where standard precautions are handled~     (favorable architecture and appropriate practice for hand hygiene), assessment of contact~     precautions to reduce the incidence of acquired bacteria during hospitalization would be of~     interest.~      The investigators design a non-inferiority comparative study to measure the colonization~     pressure in patients hospitalized in two different parts of the department: one unit only~     with standard precautions applied (intervention) and one unit with contact precautions~     (control) as current routine care.~   "
114096|NCT01562756|"~     In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research~     will pilot the study intended to pursue the following specific aims:~        -  Collect preliminary estimates of variability and effect size to identify if~          physiological measures predict patient-centered outcomes in patients with chronic low~          back pain; and~        -  Collect preliminary estimates of variability and effect size to determine if~          differences in spinal manipulation delivery, as estimated by thrust contact force and~          spinal segment load, are related to patient-centered outcomes in patients with chronic~          low back pain.~   "
114100|NCT01562704|"~     Paracetamol is one of the most widely used analgesic in the world, indicated for the~     symptomatic treatment of fever and pain. The objective of this study is to evaluate the~     mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools~     (functional MRI and test inducing pain by thermal stimulation.~   "
114101|NCT01562691|"~     The purpose of this study is to determine the effect of integrated airway in nasal packing~     material foe patients receiving nasal septoplasty surgery.~   "
114102|NCT01562678|"~     The main purpose of this study is to help us understand the effects of diabetes medication~     Liraglutide on weight loss and hunger. The investigators have already determined what the~     highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide~     was approved by the FDA in January 2010 for treatment of diabetes.~      The investigators will also study the following:~        1. The impact of Liraglutide on brain responses to food~        2. It's effect on physiological and mental performance~        3. If its effect on the brain differs among obese and lean diabetic subjects.~   "
114103|NCT01562665|"~     The overall aim of the study is:~      To provide accurate and reliable information regarding NSCLC clinical management across MENA~     region in order to detect unmet medical needs of this disease in terms of:~        -  Patient and hospital characteristics.~        -  Diagnostic and treatment approaches: initial and subsequent.~        -  Follow-up patterns in clinical management.~        -  Outcomes: symptoms, death, functionality, quality of life.~        -  Use of resources and burden on patients and health care systems.~   "
114104|NCT01562652|"~     Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated~     that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms~     of the disease are pain and functional disability.~      This study has two aims:~        1. To characterise the gait patterns and clinical parameters of patients with knee~          osteoarthritis (KOA) in Singapore at baseline, prior to treatment.~        2. To investigate the changes in gait patterns and the clinical benefits of treatment with~          a new biomechanical device, AposTherapy, for patients with KOA.~   "
114105|NCT01562639|"~     The purpose of this study is to collect following data in patients given Nexium capsule~     (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly~     recurring/relapsing reflux oesophagitis.~   "
114106|NCT01562626|"~     The purpose of this study is to test the safety and efficacy of an investigational drug~     called APS001F when given with flucytosine (5-FC) for treatment of solid tumors. APS001F is~     a recombinant Bifidobacterium longum (a live bacteria normally found in the digestive tract)~     that has been modified to produce an enzyme, cytosine deaminase (CD). The patient will first~     receive an injection of APS001F followed by oral 5-FC. APS001F is expected to go to the site~     of the tumor(s) where the agent will produce CD enzyme. CD enzyme will convert the 5-FC into~     5-fluorouracil (5-FU) which is a standard chemotherapy drug for several types of cancer.~     Additionally, some patients will also receive 10% maltose injection, a sugar that has been~     shown to enhance the growth and effectiveness of APS001F in animals. This is the first study~     where APS001F is being used in humans.~   "
114107|NCT01562613|"~     The primary objective of the study is to evaluate the proportion of hypertensive patients~     who achieve regulation of their blood pressure (BP) levels according to the European Society~     of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with~     eprosartan for 6 months under standard medical practice conditions. The absolute change in~     Systolic blood pressure from baseline will also be calculated.~      This study also aims in the evaluation of Framingham stroke risk profile score of patients~     treated with eprosartan under standard clinical practice conditions during the observation~     period. Besides the primary and the secondary objective of the study, the assessment of the~     percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs),~     Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per~     observed event) and the percentage of patients who discontinued treatment prematurely before~     the advent of the 6-month observation period due to toxicity to the study medication~     constitutes another important objective that is related to the safety of the treatment.~   "
114108|NCT01562600|"~     The purpose of this investigation is to collect following data in patients given Nexium~     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence~     of gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).~   "
114109|NCT01562587|"~     This trial is conducted in Europe. The aim of this trial is to determine the~     pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac~     patients in a non-bleeding state.~   "
114110|NCT01562574|"~     This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of~     activated recombinant human factor VII and standard treatment compared with standard~     haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric~     congenital heart disease.~   "
114111|NCT01562561|"~     This trial is conducted in Asia and South Africa. The aim of this trial is to compare the~     efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn)~     with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on~     repaglinide.~   "
114112|NCT01562548|"~     Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to~     investigate the evidence that guaifenesin is an effective treatment for upper~     back/neck/shoulder muscle spasm/stiffness and pain.~   "
114113|NCT01562535|"~     Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It~     is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when~     a parent tries to pull the child by the arm and a clic or clunk is felt with immediate~     pain and unwilling to move the arm. It is not a dangerous condition although it is~     distressing for kids and their parents/caretakers.~   "
114114|NCT01562522|"~     The purpose of the protocol, is to assess the feasibility of conducting a larger trial to~     evaluate the effect of a psychological intervention on the well-being of patients on~     luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and~     their partners.~   "
114115|NCT01562509|"~     The main objective of the proposed study is to assess the effectiveness, feasibility and~     costs of a tailored strategy (developed in accordance with the barriers found and current~     practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a~     common strategy of 'audit & feedback'.~   "
114116|NCT01562496|"~     The primary goal of this study is to determine the neuroprotective qualities of long-term,~     in home, exercise therapy program in human PD patients. It is hypothesized that an exercise~     intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection).~     The first part involves a pilot-study in which the feasibility of the intervention and~     outcome measures will be tested.~   "
114117|NCT01562483|"~     Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain~     can persist for months or even years and significantly diminishes quality of life. The exact~     underlying cause for this pain persistence is still unclear, which makes its treatment still~     a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the~     improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the~     basis of the present research proposal.~      The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic~     during a long-term treatment (52 days) of persistent postsurgical abdominal pain.~   "
114118|NCT01562470|"~     Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.~      This will be a double-blind, placebo-controlled study involving subjects with distinctive~     cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo~     to the other, by random allocation, and cellulite appearance will be measured at week 0, 8~     and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher,~     who will assess cellulite appearance on a precisely-measured upper leg area. The subjects'~     own perception of cellulite appearance, from their diaries, will be numerically coded, and~     all three measures will be collated and analysed statistically.~   "
114119|NCT01562457|"~     This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the~     intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two~     administrations of activated recombinant human factor VII in haemophilia patients in a non~     bleeding state.~      The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a~     (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM®~     parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum~     Clot Firmness) and LI60 (Lysis index 60 min after CT).~   "
114120|NCT01562444|"~     The aim of this study is to investigate the immunogenicity response in adults up to 10 years~     after one booster dose. Data collected from this study will allow for greater information to~     prescribers who administer TBE vaccine, so that they can appropriately time the~     administration of booster vaccinations to individuals who received different vaccination~     schedules and who live in tick borne encephalitis endemic regions.~   "
114121|NCT01562431|"~     Background~      An important part of individuals undergoing genetic counseling and/or testing for cancer~     experience psychosocial problems and worries during or after this process. Approximately 20%~     of these individuals experience serious problems, such as fear for cancer in themselves or~     their relatives, family communication problems, unresolved grief, problems in coping with~     the DNA-test-results, difficulties in choices with regard to DNA-testing, preventive~     surgeries, and concerns about insurance or work. Research shows that these problems are~     frequently undetected by the counselors. Within the limited available time of a counseling~     session, a lot of information should be given to the counselee. This information is mostly~     biomedical and provider driven. Therefore psychosocial issues can be underexposed. The use~     of a brief questionnaire, completed by the counselee prior to the counseling session, can~     serve as a tool for the counselor to screen and address the relevant psychosocial issues in~     a systematic manner. Therefore, in 2009-2010 the investigators have developed and validated~     the 'Signal-checklist' to identify relevant psychosocial problems frequently encountered in~     the cancer-genetics setting, and need for extra psychosocial services. This~     'Signal-checklist' can serve as a tool in screening systematically for psychosocial issues,~     addressing these issues and directing appropriate referrals to extra psychosocial services.~     The Signal-Trial will be performed to evaluate the use and effectiveness of the checklist.~      Aim~      The aim of the trial is to evaluate the implementation of a short, self-developed~     cancer-genetics checklist; the 'Signal-checklist', as an aid in 1) facilitating~     communication on psychosocial issues during the genetic counseling session, 2) increasing~     counselors awareness of psychosocial problems of the counselee, and 3) improving the~     management of these psychosocial problems during and after the process of genetic~     counselling.~      Method~      This study is a collaboration between the family cancer clinics of the NKI-AVL and the UMCU.~     Individuals requesting genetic counseling for the high incidence of cancer in their family~     are invited to participate in the trial. Participants will be asked to complete the 'Signal~     checklist' prior to their counseling visit. Participants (N=264) will be randomly assigned~     to one of the two study arms. The intervention group will receive feed-back on the~     'Signal-checklist', whereas the control group will not receive feed-back. Three weeks after~     the DNA-test disclosure session, participants will be asked to complete again the~     'Signal-checklist' followed by a telephone call by their counselor. Again, the results of~     the 'Signal-checklist' will be available to the counselor for participants in the~     intervention group, but not for the control group. Both the genetic counseling session and~     telephone call will be audio taped. Furthermore, all participants will be asked to complete~     three questionnaires on the Internet (or by mail, if preferred); 1) before randomization (3~     weeks prior to the counseling session), 2) three weeks after the counseling session, and 3)~     four months after the potential DNA-test result disclosure. These questionnaires include~     items on communication during genetic counseling, the need for professional psychosocial~     support, cancer worries, satisfaction with received care, and experiences with the use of~     the 'Signal-checklist'. The audio-tapes and completed questionnaires will be used to measure~     psychosocial problems of the counselees, the awareness of the counselors of these problems,~     and the management of these problems. Secondary analysis will be conducted to assess the~     need for extra psychosocial services, satisfaction with genetic counseling, feasibility of~     implementing the 'Signal-checklist' and decreasing psychosocial problems over time.~   "
114122|NCT01562418|"~     Computer settings points to a number of risk factors which may induce the development of~     Work related MSD (WRMSD). In light of the expanded use of computers and the increased~     occurrence of Upper Extremity (UE) WRMSD among computer operators various intervention~     programs have been developed and tested. Nevertheless, many of these programs do not meet~     the criteria of quality and level of evidence.~      The main objective of this study is to use simultaneously a three dimensional (3D) kinematic~     analysis system, surface electromyography (SEMG) and fingertip force measurement system~     (Flexiforce) while typing, to test the efficacy of primary and secondary preventive~     intervention programs aimed at reducing MSD among computer operators.~      Work hypothesis: Significant score differences will be found on the evaluation parameters~     between the research group which underwent ergonomic training with biofeedback, the group~     without feedback, and the control group.The evaluated parameters will correlate with the~     appearance of MSD symptoms and pain and will affect level of function.~      The study will include 66 participants, programmers and computer engineers. The participants~     will be assigned randomly to one of three groups: 1) participants will receive ergonomic~     training with biofeedback; 2) participants will receive ergonomic training without~     biofeedback; and 3) control group, without intervention. Each group will consist of 22~     participants.~      Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D~     kinematic measurements and fingertip forces relevant to typing while entering a standard~     text will be measured. At the work site, anthropometric and measurements, work station~     measurements, posture observation and questionnaires about, psychosocial status, function~     and pain level will be filled The preventive program will be performed at the workstation~     after the preliminary data collection phase. The program will consist of one group meeting~     at the workplace for all employees participating in the study, and individual instruction at~     the workstation, including 3-6 meetings for the two research groups. Data will be collected~     before and after the intervention program.~   "
114123|NCT01562405|"~     It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or~     prevent the growth of cancer cells along with improving anemia and bone lesions that~     sometimes occur in people with multiple myeloma.~      This current study is the first study combining ACE 011 with lenalidomide. In this research~     study, the investigators are looking for the highest dose of ACE 011 that can be given with~     lenalidomide and dexamethasone. The investigators will also begin to collect information~     about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple~     myeloma.~   "
114124|NCT01562392|"~     The purpose of the study is to study the potential anti-inflammatory- and metabolic effects~     of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries~     and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In~     addition the purpose is to investigate the effects on cognitive functions of the berry~     product.~   "
114125|NCT01562379|"~     The purpose of this study is to test the impact on child growth of three specially~     formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially~     available complementary food, and vs. a control group that receives no food. All groups will~     receive nutrition education related to infant and young child feeding. This will be a~     cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in~     Bangladesh.~   "
114126|NCT01562366|"~     Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater~     Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a~     difference between the two treatment groups.~   "
114127|NCT01562353|"~     This is a clinical study on patients who have been prescribed opioids (narcotic pain~     relievers) for the treatment of pain, to determine what genetic factors influence outcome of~     treatment. Procedures include: an initial telephone prescreening, completion of a number of~     questionnaires, and a blood draw to determine genetic factors. Participants will take part~     in a one-time clinic visit, during which all procedures will be completed.~      The investigators hypothesize that several classes of genes, including genes in opioid,~     pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed~     nondependent subjects.~   "
114128|NCT01562340|"~     In this study, the investigators will administer pomegranate juice or fruit extract as a~     targeted antioxidant therapy to hemodialysis patients.~      The investigators will examine whether these pomegranate products will be safe and~     well-tolerated. The investigators will also examine whether these products may lead to~     improvements in blood serum biomarkers of:~        -  oxidative stress status~        -  inflammatory status~        -  endothelial dysfunction~   "
114143|NCT01562145|"~     The aim of the study was to investigate the levels of matrixmetalloproteinases and their~     inhibitors in blood samples from patients with rotator cuff tears and compare with blood~     samples from healthy matched controls.~   "
114130|NCT01562314|"~     Ulcerative Colitis is an inflammatory bowel disease (IBD) effecting large amounts of the~     population. The most common treatment for this condition is 5-aminosalicylic acid (5-ASA),~     however patients failing to respond to this and incurring a flare up are often escalated to~     steroidal treatments.~      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the~     efficacy and safety of GWP42003 (0mg - 250mg twice daily), compared with placebo, by the~     percentage of participants achieving remission quantified as a Mayo score of 2 or less (with~     no subscore > 1) after 10 weeks treatment.~      This is the first study to determine whether the study medication has a positive benefit for~     subjects on their ulcerative colitis symptom control, as well as effects on inflammatory~     marker cytokines (plasma tumour necrosis factor [TNF]α, interleukin [IL]-2, IL-6), C~     reactive protein [CRP], faecal inflammatory marker (calprotectin), stool frequency (NRS),~     rectal bleeding (NRS), pain (NRS). In addition, various IBD questionnaires are being~     implemented in the study to observe further benefits on the study medication, compared with~     placebo.~      This study will be a multi-centre, randomised, double-blind, placebo-controlled,~     parallel-group pilot study. There will be two parallel groups of participants (0mg-250mg~     GWP42003 and placebo, twice daily), with a treatment duration of 10 weeks as well as a 7 day~     baseline period and one week follow-up. The two treatment groups of 0mg-250mg GWP42003 and~     placebo will be randomised equally into a 1:1 ratio, with 31 participants in the active IMP~     group and 31 participants allocated placebo treatment.~      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years~     and above (18-65 for Czech Republic) and be clinically diagnosed with with mild or moderate~     ulcerative colitis and on a fixed dose of 5-ASA treatment (0 mg dose of 5-ASA is acceptable)~     and have been on a stable dose for at least 2 weeks prior to screening.~      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a~     baseline period. Each subject will have a Mayo (including endoscopy) assessment conducted to~     confirm eligibility. If eligible, the subject will be randomised into the 10-week treatment~     phase. There are a total of 6 visits in the study.~   "
114131|NCT01562301|"~     The goal of this clinical research study is to find the highest tolerable dose of Anvirzel~     (Nerium Oleander) that can be given to lung cancer patients receiving standard therapy with~     carboplatin and docetaxel. Researchers also want to learn what effect Nerium Oleander may~     have in combination with carboplatin and docetaxel.~   "
114132|NCT01562288|"~     RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received~     chemotherapy with or without trastuzumab may help doctors learn more about the effects of~     trastuzumab on cells. It may also help doctors understand how well patients respond to~     treatment.~      PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer~     treated with chemotherapy with or without trastuzumab.~   "
114133|NCT01562275|"~     This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety,~     tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in~     combination in patients with locally advanced or metastatic solid tumors. Cohorts of~     patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on~     study treatment is until disease progression or unacceptable toxicity occurs.~   "
114134|NCT01562262|"~     Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have~     excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with~     increasing reaction time to external stimuli and correlates with excessive sleepiness. So,~     the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it`s~     maintenance in patients with OSAS compared with healthy, to better clarify were patients~     with and without somnolence differ. For that, will be recruited 30 male volunteers aged~     between 20 and 50 year old to participate in the study. They will be distributed in three~     groups: CONTROL (without symptoms of sleepiness and apnea and hypopnea index (AHI) less~     than 5), SS (with AHI between 5 and 15 without symptoms of somnolence) and group CS~     (with AHI between 5 and 15 with symptoms of somnolence). The groups will undergo a~     polysomnography and subsequently, the Test and Maintenance of Wakefulness and PVT Battery~     Tests. The reaction time will be compared, as well as the ability to keep the reaction time~     over time between groups to see whether there is a difference between the motor performance~     throughout the day and the perception of sleepiness.~   "
114135|NCT01562249|"~     The purpose of this study is to verify the effectiveness of a systematic rehabilitative~     program for mastication in patients submitted to orthognathic surgery.~   "
114136|NCT01562236|"~     Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome~     following preterm birth. The investigators aimed to investigate gender-related differences~     in amplitude-integrated electroencephalography (aEEG) and to correlate these findings with~     neurodevelopmental outcome.~      Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were~     prospectively included. aEEGs obtained within the first two weeks of life were evaluated and~     classified according to background activity, sleep-wake cycling (SWC) and seizure activity.~     Outcome was assessed at three years.~   "
114137|NCT01562223|"~     RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance~     imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate~     cancer or any cancer that remains after biopsy.~      PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate~     cancer.~   "
114138|NCT01562210|"~     Phase I dose escalating trial. Primary objective of this study is to define the maximal~     tolerated dose (MTD)of Olaparib in combination with high dose radiotherapy with or without~     daily dose Cisplatin in locally advanced NSCLC. Secondary objectives include to define~     safety profile, determine PK/Pd variables and document preliminary evidence of objective~     tumor response.~   "
114139|NCT01562197|"~     This clinical trial will recruit patients diagnosed with glioblastoma at the time of~     recurrence or progression following prior treatment with surgery, radiation therapy and~     alkylating chemotherapy. Patients will be screened and if found eligible will be randomized~     to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib~     treatment-arm will be treated with Axitinib until progression (they can be treated after~     progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or~     patients refusal to continue study treatment. Patients randomized to the Axitinib plus~     Lomustine-arm will receive treatment until progression, unacceptable treatment related~     toxicity, or patients refusal to continue study treatment.~   "
114140|NCT01562184|"~     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression~     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled~     trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing~     its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and~     biomarkers will be measured during the trial.~   "
114141|NCT01562171|"~     Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks~     will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with~     high cholesterol and obesity.~   "
114149|NCT01562067|"~     Cervical tumors are characterized by vascular changes (in terms of quantity, volume and~     Flows) in the tumor. Due to a good access to the cervix through the vagina, these parameters~     can be assessed using a three dimensional supersonic. Sonographic characteristics of tumor~     indices measures before and after oncological treatments may shed light on the patient's~     prognosis.~   "
114150|NCT01562054|"~     The operating room, OR, is a high-tech and complex domain in which clinicians' possession of~     clinical knowledge and good technical skills are essential, but not sufficient.~     Retrospective studies have shown that a large proportion of the mistakes that occur during~     surgery are not caused by lack of clinical skills but rather by insufficient communication~     and teamwork. Prospective studies have shown that insufficient teamwork in the OR causes a~     higher risk of complications and that communication failure in the surgical team causes~     procedural errors and delays. It is therefore evident, that surgeons and the surgical teams~     need skills in communication, teamwork, decision making and leadership (so called~     non-technical skills) to ensure a good outcome for surgical patients.~      Internationally different behavioural marker systems have been developed to aid training and~     assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from~     Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula~     for surgical trainees, but no formal training or assessment occurs at this point.~      The investigators developed a behavioural marker system for general surgeons adapted to the~     Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists~     of four categories: leadership, situation awareness, decision making and communication &~     teamwork. Each category has between 3 and 4 elements underpinning it and each element has~     several behavioural examples illustrating good and poor behaviour.~      The system needs evaluation to ensure that it is valid and can be used reliably to observe~     and rate surgeons' intra operative performance.~      Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation~     to it's construct validity, reliability, and usability in a simulated setting.~      Research questions:~        -  What is the inter rater reliability among raters?~        -  Are these ratings consistent with expert ratings (= gold standard ratings)?~        -  Can a one day training session improve novice raters' agreements (construct validity)?~      METHODS The study is designed to explore the reliability of the ratings made by surgeons as~     well as to examine whether the reliability improves with training. The study setting will be~     a one day course in which surgeons are asked to rate the non-technical performance of~     surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The~     first at the beginning of the day when the surgeons have had no prior training in or~     knowledge of rating non-technical skills and at the end of the day after 5 hours of~     training.~      Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited~     to participate as raters after the heads of the departments have been contacted and informed~     about the project. The investigators wish to recruit consultant surgeons (n=10) and senior~     residents in surgery (n=10) who have an interest in education and supervision. Once~     recruited background information such as age, gender, position, years of surgical experience~     and prior experience with assessment of others will be collected.~      Training and rating session The surgeons will attend a one day course. The course will~     consist of three parts: first a rating session to get baseline-ratings from participants of~     6 video scenarios, then a teaching and training session and then another rating session with~     4 new and 2 of the baseline-videos. During the first rating session the surgeons will only~     have the NOTSSdk rating form and will not be allowed to discuss with each other. The second~     rating session will be like the first but in addition to the rating form the participants~     will also be allowed to look in the full NOTSSdk behavioral marker system. The teaching will~     include an introduction to Human Factors and non-technical skills in surgery, and a short~     description of the development and intended use of NOTSSdk. The following training will~     allow participants to practice the rating of surgeons' non-technical skills on 4 video~     recorded scenarios and then discuss their ratings.~      Ratings of the lead surgeons' performance will be obtained at the category level of each~     scenario.~      Video recordings 14 simulated video recordings will be made showing general surgeons~     acting in their own roles during surgery. The scenarios will be scripted to display~     various scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy)~     and non-routine situations (such as unexpected bleeding during open surgery). The scenarios~     will be designed after a specific structure aiming at a specific variation in the surgeons'~     non-technical performance according to the four categories of NOTSSdk.~   "
114151|NCT01562041|"~     The study is designed to evaluate the use of ETT ECG indices as biomarkers in the assessment~     of atherosclerotic coronary vascular disease (ASCVD).~   "
114152|NCT01562028|"~     Rationale:~      Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor~     receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival~     between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations~     can only imperfectly predict outcome. The investigators hypothesize that progression-free~     survival could be influenced both by the pretreatment EGFR T790M mutation and by components~     of DNA repair pathways.~      The investigators propose a model of treatment whereby patients with EGFR mutations (single~     or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus~     bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is~     that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.~   "
114153|NCT01562015|"~     Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior~     therapies. The study will take place globally at multiple study centers. Subjects will be~     enrolled to receive ganetespib one time per week for three weeks followed by a rest week;~     and will repeat this schedule until the cancer gets worse or the subject is unable to~     tolerate ganetespib. The primary goal of the study is to determine how ganetespib is~     tolerated and how active it is in ALK positive NSCLC.~   "
114154|NCT01562002|"~     The purpose of the study is to determine whether allogenic bone marrow stem cell transplant~     is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic~     limbus stem cell transplant.~   "
114155|NCT01561989|"~     This randomized clinical trial studies cholecalciferol and flu vaccine in treating healthy~     participants. Cholecalciferol may increase the immunologic response of flu vaccine in~     healthy participants. Flu vaccine may help the body build an immune response and help~     prevent flu~   "
114156|NCT01561976|"~     Metformin hydrochloride in its immediate release (IR) form has been successfully used for~     decades in the treatment of type 2 diabetes; however the IR formulation may be associated~     with gastrointestinal side effects (especially nausea, diarrhea) in 20-30% patients, which~     can limit the tolerated dose, reduce adherence and result in discontinuation of therapy.~     Metformin hydrochloride extended release formulations have been developed to overcome these~     problems. In India, extended release formulations of metformin hydrochloride include~     metformin SR 1000mg tablet and combination of metformin hydrochloride SR 1000mg/glimepiride~     2mg tablet. In the combination tablet, only metformin hydrochloride is in the extended~     release form. In view of the fact that extended release metformin hydrochloride is usually~     recommended with a meal, that food is known to affect the pharmacokinetic (PK) parameters of~     metformin and that there is a potential for dose dumping with extended release formulations~     that may lead to side effects similar to IR formulations, a study to estimate the magnitude~     of the food effect for these formulations in fed state compared to the fasting state is~     warranted. This study will be a randomized, single-center, open-label, single-dose,~     three-period, 6 sequence crossover study in 30 healthy adult volunteers to estimate the~     bioavailability of metformin from metformin hydrochloride 1000mg SR tablet given in fasting~     condition relative to metformin hydrochloride 1000mg SR tablet and a fixed dose combination~     of metformin hydrochloride 1000mg SR /glimepiride 2mg tablet, each given in fed condition.~     The safety and tolerability profile of metformin SR 1000mg tablet and metformin~     hydrochloride SR 1000mg/glimepiride 2mg tablet will also be evaluated in this study. The~     primary PK endpoints will be Cmax and AUC (0-∞). The secondary PK endpoints will include AUC~     (0-t), Tmax , T lag, Kel and t1/2. Safety endpoints will include vital signs, ECG, physical~     examination, clinical laboratory tests and adverse event reporting.~   "
114157|NCT01561963|"~     The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be~     affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.~   "
114158|NCT01561950|"~     This trial is conducted in the United States of the America (USA). The aim of this trial is~     to evaluate the effectiveness of activated recombinant human factor VII to mitigate~     experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).~   "
114159|NCT01561937|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the efficacy of activated recombinant human factor VII to mitigate~     experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a~     targeted INR (International Normalization Ratio).~   "
114160|NCT01561924|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM®~     (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in~     a non-bleeding state.~   "
114161|NCT01561911|"~     The Purpose of this study is to evaluate the safety and tolerability, and the biological~     effects of the chimeric anti-CD40 monoclonal antibody Chi Lob 7/4, given intravenously,~     weekly for 4 weeks in the treatment of patients with advanced malignancies refractory to~     conventional anti-cancer treatment.~   "
114162|NCT01561898|"~     The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients~     with schizophrenia over a long term period.~   "
114163|NCT01561885|"~     The aim of this study is to determine if by providing a collaborative, integrated~     pathway-based healthcare compared to the usual healthcare, whether or not this would be~     superior in reducing the length of hospital stay across five high frequency /high risk~     medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired~     Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.~   "
114164|NCT01561872|"~     2 URCC in the Limousin region will be equipped with the automated telesurveillance system.~     Patient will be selected by ward's geriatrician and randomized into two groups after~     informed consent. One group will have cameras installed and the other will not and will act~     as a comparison group. Patient will be assessed twice during the study, at admission in~     (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies~     a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for~     behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be~     considered as adverse events and will therefore be listed along the study and characterized~     in types and number.~   "
114165|NCT01561859|"~     The proposed project is designed to examine the effects of cognitive rehabilitation on brain~     structure and function in a randomized trial of 102 early course schizophrenia patients~     treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched~     Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.~   "
114166|NCT01561846|"~     In this study the investigators aimed at verifying whether consumption of a sheep cheese,~     naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid~     profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double~     blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in~     Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched~     cheese for 3 weeks, with a cross over after 3 weeks of washout.~   "
114167|NCT01561833|"~     This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell~     lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy~     (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other~     transformed T-cell lymphomas with the primary objective of studying the biological effects~     of the multikinase inhibitor, sorafenib.~   "
114168|NCT01561820|"~     This is a small pilot trial of a 5 month aerobic exercise intervention in participants with~     MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to~     exercise without an assigned buddy. The investigators hypothesize that participants with MCI~     who exercise with a buddy will have higher adherence to the protocol and greater improvement~     in 400 meter walk time.~   "
114169|NCT01561807|"~     The purpose of this study is to determine the antiviral activity and safety of VX-787 given~     to healthy adult volunteers that have been inoculated with the influenza virus.~   "
114170|NCT01561794|"~     The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the~     relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and~     Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID)~     in hospitalized patients with bacterial pneumonia or secondary infection of chronic~     respiratory disease with severe disease or a poor response to other antimicrobials. In~     addition, the efficacy of the ciprofloxacin, in terms of clinical response and~     microbiological response, will be investigated, but as a secondary endpoint.~   "
114171|NCT01561781|"~     This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin~     administered alone and in combination with Vandetanib.~   "
114172|NCT01561768|"~     The purpose of this study is to determine the immune response of three dose levels of the~     Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into~     5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group~     1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will~     receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially~     available trivalent influenza vaccine (TIV). The study will also evaluate the safety and~     tolerability of the Novavax Quadrivalent vaccine.~   "
114173|NCT01561755|"~     The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an~     effective treatment for HIV associated myelopathy.~   "
114174|NCT01561742|"~     This study aims to examine the efficacy of minocycline augmentation in a sample of~     moderately ill outpatients with early-course schizophrenia on their~     chlorpromazine-equivalent doses of second-generation antipsychotic medications. The~     investigators hypothesize that as compared to placebo a 2-month treatment with minocycline~     in 120 volunteers with early-course schizophrenia will result in a more significant~     improvement in psychopathology (primary outcome) and cognitive symptoms (secondary outcome).~     In addition, cytokine plasma levels will be used as another secondary outcome measure to see~     if treatment-induced changes in total PANSS score are associated with changes in cytokine~     levels.~   "
114175|NCT01561729|"~     This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if~     there is proper placement of a nasogastric or orogastric tube.~   "
114176|NCT01561716|"~     The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus~     games as compared with resting and treadmill walking/running.~   "
114177|NCT01561703|"~     This study is designed to look at healthcare utilization following the removal of tonsils~     and adenoids in pediatric patients who are not given an antibiotic following surgery.~   "
114178|NCT01561690|"~     This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the~     effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent~     asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the~     US will be enrolled in this study.~   "
114179|NCT01561677|"~     Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but~     little is known about the consequences of OSAS on the outcome and the survival after stroke.~     The aim of the investigators study is first to evaluate the outcome and the survival of~     patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare~     the outcome and survival of patients with severe OSAS depending on the treatment of the~     syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is~     that OSAS is associated with worst survival and outcome and needs to be treated at the~     subacute phase of stroke.~   "
114180|NCT01561664|"~     Insulin resistance is one of the main mechanisms involved in metabolic diseases.~     inflammation has been implicated in its pathogenesis, due to innate immunity activation by~     free fatty acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate~     activate innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4,~     NFkB, IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b,~     IL6), chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in~     TLR signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in~     inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been~     recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI~     and RNase L in TLR regulation, and its potential implication in the link between obesity,~     inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.~   "
114203|NCT01561365|"~     The aim of this prospective study was to compare outcomes in patients handled by emergency~     physician according to OAR versus by an orthopedic resident.~      92 consecutive patients with ankle injuries attending our emergency department were divided~     in two groups. The study group comprised 32 patients who arrived during the morning shift~     and were examined by an emergency physician according to OAR. Patients discharged without an~     x-ray were followed in the clinic or by telephone communication. The control group~     constituted 60 patients who were examined during the evening and night shifts by orthopedic~     residents unaware of this study.~   "
114181|NCT01561651|"~     Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all~     strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as~     coumadin. Although these blood thinners are effective, they are limited by the risk of~     serious bleeding, by physician and patient reluctance to use, and by noncompliance and~     discontinuation. The left atrial appendage is a structure on the upper chamber of the heart~     that is the most common source of stroke in patients with AF. This structure is easily~     accessible during open heart surgery for removal, and has been an area of interest for~     stroke prevention. However, there is currently no strong evidence that removing it works.~      The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF~     undergoing heart surgery for other reasons to have the left atrial appendage removed or not.~     These patients, other than this small procedure which has been shown to be quite safe, will~     be treated in the usual manner. The full study of 4700 patients, followed for an average of~     4 years, will determine if removing the left atrial appendage can reduce stroke and other~     complications on top of usual therapy. A positive study will change the way heart surgery is~     performed on AF patients and results in a large reduction in the number of strokes in a~     large population. Further, it will promote further research into this approach that could be~     applied beyond AF patients undergoing heart surgery.~   "
114182|NCT01561638|"~     The pulsed dose RF treatment in various painful disorders may provides better pain relief~     with longer duration compared to previous Pulsed Radiofrequency (PRF) treatment in similar~     clinical settings. Also, there would has not been any worrisome complications from the~     procedures.~   "
114183|NCT01561625|"~     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary~     disease (COPD). Although resistance exercises increase strength and muscle mass in patients~     with COPD, the response to training appears to be suboptimal in these individuals. A~     dysregulation in the signaling pathways involved in the regulation of muscle mass could play~     an important role in this phenomenon.~      Hypothesis: Proteins involved in muscle mass regulation will be less activated in the~     quadriceps of patients with COPD following the acute bout of resistance training exercise~     compared to healthy age-matched controls.~   "
114184|NCT01561612|"~     The overall goal of the PROBIT study is to investigate the influence of a randomized~     breastfeeding promotion intervention designed to increase the duration and exclusivity of~     breastfeeding (the breastfeeding promotion intervention) on the development of maternal~     and child health outcomes. The hypothesis is that randomization to the intervention will be~     associated with lower child adiposity, lower risk of asthma and atopy, improved lung~     function, and improved cognitive outcomes.~   "
114185|NCT01561599|"~     The study is designed to evaluate the safety and efficacy of an intravenously administered~     drug in recipients of kidneys from cardiac death donors who are risk for developing delayed~     graft function.~   "
114186|NCT01561586|"~     Current standard treatment for locally advanced cervical cancer is cisplatin-based~     concurrent chemoradiation (CRT). Although recently reported meta-analysis studies also~     demonstrated improved local control rates and survival with cisplatin-based chemotherapy~     concurrent to radiation therapy (RT), the optimal cisplatin dose and dosing schedule are~     still undetermined.~      In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered~     to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized~     phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better~     outcome in locally advanced cervical cancer.~      In this randomized phase III trial, the investigators investigate that there may be a~     survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2~     administration concurrent to RT in cervical cancer.~   "
114187|NCT01561573|"~     PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in~     the evaluation and reduction of colles fractures as compared with traditional pre and post~     reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility~     in guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final~     assessment of reduction adequacy.~   "
114188|NCT01561560|"~     The purpose of this crossover study was to evaluate the end-of-day comfort of two~     commercially available, daily disposable, silicone hydrogel contact lenses.~   "
114189|NCT01561547|"~     Mothers can provide pain relief to their newborns, even in the context of intensive neonatal~     care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane~     review, that mothers holding their infants in a bare-chested skin-to-skin position, known as~     Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single~     painful procedure. While evidence is compelling, leading to recommendations for its use, to~     date there is not a single study on the repeated efficacy to reduce pain. Current guidelines~     recommend sweet taste for minor painful procedures. Although there is some controversy about~     its continued use in this population based on one study with negative neurodevelopmental~     outcomes as well as its potential interaction with dopaminergic development, oral sucrose~     (sweet taste) remains efficacious in decreasing pain response over several weeks. The~     combination of KMC and sucrose is marginally more potent, but again, long term use remains~     unstudied.~      AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to~     usual care (sucrose), and of KMC in combination with sucrose by examining each condition at~     least three times during NICU stay. A secondary aim is to compare these interventions on~     neurodevelopment at discharge from the NICU.~   "
114204|NCT01561352|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess the efficacy of activated recombinant human factor VII in the treatment of refractory~     haemorrhagic cystitis (HC) following chemotherapy.~   "
114217|NCT01561170|"~     Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous~     insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency~     of the disease, primarily among elderly people. Recently, electromagnetic field therapy has~     been tested on various diseases in musculoskeletal system with a beneficial effect. In~     recent years, there has been an increasing interest in using electromagnetic field therapy~     to treat chronically venous ulcer.~      The hypothesis of the investigators is that the electronic magnetic field therapy improves~     the healing process and reduces pain for patients suffering from chronically venous ulcer.~     The investigators assume that the bioactivity is affected by a cellular response which~     affects the DNA synthesis, transcription og protein synthesis.~   "
114190|NCT01561534|"~     The rehabilitation of patients affected by defects of the jaws after tumor resection is~     still very challenging. Resection can lead to significant facial deformity, impaired oral~     functions such as speech, swallowing, saliva retention, and concomitant psychological~     problems. Moreover, the loss of teeth and the alveolar and basal jawbone can lead to~     significant impairment of mastication. The reconstruction of such defects with autogenous~     bone grafts or revascularized free flaps has become a valuable means for the rehabilitation~     of these patients. Major benefits of such procedure include an usually low morbidity of the~     donor site and an extensive length of the bone graft. Moreover, vascularized grafts provide~     a good bulk of bone in which to place implants and a satisfactory contour. In fact, after~     reconstruction, local hard and soft tissue conditions often exclude the integration of~     conventional dentures because of the impairment of dental prosthetic retention by thin~     cutaneous tissue, the thickness of subcutaneous tissues, the absence of a perilingual and~     vestibular groove, and the fragility of soft tissues. In Literature it has been well~     established the high biologic value of vascularized fibula grafts regarding the potential of~     implant osseointegration, which seemed to be equal to regional mandibular or maxillary bone~     and eventually capable to provide sufficient stabilization of prosthesis.~      It must be kept in mind that the final prosthetic success may be affected by some~     difficulties in this clinical scenario. These include the limited opening of the~     scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little~     information about the profile of the underlying harvested bone, the need for limited bony~     exposure in a field that may well have been irradiated and they all may cause poor~     prosthetically-guided implant positioning and eventually disappointing results in dental~     rehabilitation, either functionally or esthetically. It can be postulated that these~     complications can be overcome, or at least reduced, by adopting the new methods of computed~     tomography (CT)-assisted implant surgery.~   "
114191|NCT01561521|"~     The purpose of this study is to evaluate the onset and duration of action of two~     concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen~     challenge (CAC) model of acute allergic conjunctivitis.~   "
114192|NCT01561508|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the body's immune system~     attacks and destroys the insulin producing beta cells of the pancreas. This condition is~     very prevalent, affecting up to 1:400/500 persons worldwide. Type 1 diabetes, previously~     known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood,~     but lasts for a lifetime. To date, there have been no treatments that can arrest or reverse~     the ongoing beta cell destruction. The patients affected by this disease require multiple~     daily insulin injections to manage their blood sugars and usually have trouble regulating~     their blood sugars. Moreover, they are at risk for heart disease, kidney failure, eye~     problems, and other complications from this life-long condition.~      The investigators plan to utilize gamma-amino butyric acid (GABA) in children with newly~     diagnosed T1DM. This neurotransmitter is made in the brain from the amino acid glutamate~     with the aid of vitamin B6. There have been some recent studies in diabetic mice utilizing~     GABA to reverse inflammation on the pancreas and improve hyperglycemia. GABA studied in~     healthy human subjects demonstrated that large oral doses of GABA increased insulin~     secretion from the pancreas.~      The investigators propose that GABA given to children with new onset T1DM will be able to~     increase insulin production, suppress glucagon release, and decrease the inflammation~     surrounding the pancreas. The investigators hope this will at least prolong the beta cell~     life after diagnosis, if not lead to a cure for type 1 diabetes.~   "
114193|NCT01561495|"~     This is a study of proton radiotherapy for the pre- or post- operative treatment of patients~     with extremity sarcoma. This study will treat patients in two dose groups:~        1. patients receiving pre-operative proton therapy and~        2. patients receiving post-operative proton therapy. In each dose group, the study is~          divided into two phases. In the first phase of the study, the investigators will~          determine if treatment with proton therapy is safe and can be delivered on a regular~          basis. In the second phase, the investigators will determine if proton therapy has less~          long term side effects compared to standard radiation in both pre-operative patients~          and post-operative patients.~   "
114194|NCT01561482|"~     The purpose of this study is to find out whether the two drugs used in the study, metformin~     and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop~     its rise or even bring the level down.~      Recently, scientists noticed that men who take metformin to treat their high blood sugar or~     simvastatin to treat their high cholesterol are less likely to develop prostate cancer.~     Also, scientists found that, when these drugs are used in preclinical studies, they can slow~     down the growth of the prostate cancer cells. This study will try to find out whether these~     drugs can actually slow down the growth of prostate cancer in men.~   "
114195|NCT01561469|"~     The objective of this study is to review the local management of patients with~     methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with~     vancomycin or linezolid with the goal to define if any difference exists among these~     antimicrobials in regard to clinical and economic outcomes.~   "
114196|NCT01561456|"~     The purpose of this study is to compare effectiveness and safety of experimental anticancer~     medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma~     of the lung.~   "
114197|NCT01561443|"~     This is the first study focused on features/stereotypes of the first and second-line~     treatment patterns in Russia, comparison of different treatments, and determination of~     effective hormone treatment patterns in real-life practice with evaluation of~     pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical~     effectiveness of second-line hormone treatment and quality of life in patients with breast~     cancer(BC).~   "
114198|NCT01561430|"~     The purpose of this Phase 2 study is to evaluate how the body handles the drug and the~     drug's effect on the body of participants with mild cognitive impairment (MCI) due to~     Alzheimer's Disease (AD) or mild AD who test positive for amyloid plaque.~   "
114199|NCT01561417|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence~     between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a~     new formulation stable at 25°C (VII25).~   "
114200|NCT01561404|"~     This is an exploratory study based on the hypothesis that kidney transplant patients treated~     with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin~     (m-TOR) may increase resistance to physical exercise, which would result in an improvement~     in the quality of life of these patients.~   "
114201|NCT01561391|"~     This trial is conducted in North America. The aim of this trial is to compare the safety and~     efficacy of activated recombinant human factor VII in patients with haemophilia A or B~     undergoing major surgical procedures.~   "
114202|NCT01561378|"~     The goal of this study is to determine the potential ability of intranasal insulin to~     prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac~     surgery population.~   "
114205|NCT01561326|"~     Objective: Previous studies have suggested that psycho-educational interventions delivered~     by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further~     explore strategies for enhanced follow-up to medical care recommendations, we studied the~     impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at~     2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive~     telephone barriers intervention was compared to an enhanced comparison group and a group~     that received tailored print materials.~      Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly~     assigned to: 1) telephone assessment of barriers to follow up adherence recommendations~     combined with tailored telephone barriers counseling; 2) telephone assessment combined with~     tailored barriers print brochure; or 3) telephone assessment with no barriers counseling.~     Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.~   "
114206|NCT01561313|"~     This study will compare injection site pain levels between current Humira® formulation~     versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are~     either currently on a stable dose (minimum six consecutive doses) of on-label Humira or~     biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid~     Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech~     Republic (3 sites).~   "
114207|NCT01561300|"~     This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract,~     equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.~   "
114208|NCT01561287|"~     Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer~     patients undergo some form of breast reconstruction. Several types of reconstructive~     procedures are available for appropriate patients. A reconstructive sequence consisting of a~     tissue expander followed by permanent implant placement is a popular choice for many women.~     In the past several years, acellular dermal matrices (allografts) have been used at the time~     of tissue expander placement to extend submuscular coverage. Reported benefits include the~     ability to initially fill the expander to a greater extent, improved control of the~     inframammary crease, and possible decrease in capsular contracture rate. Potential~     disadvantages of dermal allografts include foreign body reaction, incomplete tissue~     integration, or increased infection rates. The latter is especially worrisome, as infection~     in the setting of a tissue expander often necessitates the removal of the implant and~     interruption of the reconstructive sequence. There have been a few scattered reports of the~     use of dermal autografts in implant-based breast reconstruction, but they have not been~     widely used. Dermal autografts carry the potential benefit of improved tissue integration~     and lowered complication rates. However, to date there have been no studies which compare~     acellular dermal allograft matrices to dermal autograft for use in breast reconstruction.~     The objectives of this study are to compare dermal allograft to dermal autograft with~     respect to cost, tissue integration, patient satisfaction with scar, and complication~     profile in patients undergoing mastectomy followed by tissue expander/implant~     reconstruction.~   "
114209|NCT01561274|"~     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.~     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and~     is one cause of this hypotension. The higher the spread of the blockade will result in a~     higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to~     spread within the intrathecal space before it will be taken up by the nerve roots. The time~     that a patient remains in one position after medication injection will affect the spread of~     the resultant anesthetic block. A patient who is left sitting for a longer period of time~     after injection of hyperbaric medication will have a lower level of block than someone who~     is placed supine immediately. In this study, the investigators wish to use up down~     sequential analysis to determine the time period a patient should remain seated after~     intrathecal injection of hyperbaric bupivacaine that will result in a 50% rate of~     hypotension.~   "
114210|NCT01561261|"~     The long-term objective is to develop a tool to aid in making a timely and accurate~     diagnosis of acute compartment syndrome (ACS).~      The immediate objective is to develop a model to accurately predict the likelihood of ACS~     based on data available to the clinician within the first 48 hours of injury (specific~     clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy~     (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).~      Our primary outcome is the retrospective assessment of the likelihood of compartment~     syndrome made by a panel of clinicians using the following data:~        -  A physiologic fingerprint composed of continuous pressure versus time curve,~          continuous oximetry values, response of muscle to fasciotomy when performed, and serum~          biomarkers of muscle injury (CPK levels).~        -  Clinical and functional outcomes at 6 months post-injury including: sensory exam,~          muscle function, presence/absence of myoneural deficit, and patient reported function~          using the Short Musculoskeletal Function Assessment (SMFA).~   "
114211|NCT01561248|"~     The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli~     (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop~     hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.~   "
114212|NCT01561235|"~     Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how~     protein exerts its effect on appetite is not fully known. The effect have been suggested to~     be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also~     to a greater thermogenic effect causing greater increase in core temperature. The~     involvement of peripheral appetite-regulating hormones has only been sparingly investigated.~      The objective is to investigate the satiating effects of meals with varying content of~     meat-based protein and whether a dose-response effect can be found on appetite-regulating~     hormones and appetite ratings.~      Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The~     test meals is isocaloric with 30E% fat and increasing protein content at the expense of~     carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein~     content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite~     ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will~     served an ad libitum lunch.~   "
114213|NCT01561222|"~     Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression~     so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.~   "
114220|NCT01561131|"~     The primary aim is to examine the effect of a high protein intake (from soy or whey protein)~     on weightmaintenance after weight loss in a group of predisposed (severe) obese persons.~     Furthermore, to examine short-term and long-term effect of a high protein intake on appetite~     regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on~     weightmaintence, bloodlipid profilen, appetite regulation and DIT.~      The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie~     diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200~     overweight/obese subjects will be enrolled into the study and randomized to placebo~     (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At~     baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight~     and composition will be measured and blood samples will be collected. Meal test will be~     performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces~     will be collected three times during the study. Subjects will receive dietary counseling (in~     groups) regularly during the study and body weight will be measured at each visit.~   "
114221|NCT01561118|"~     Physical activity is considered essential for optimal health, development, socialization and~     well-being of children. However patients with end-stage renal disease (ESRD) are often~     restricted from participation in exercise activities. This is especially true for children~     on hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but~     most impressively after HD. In a nationwide randomized, multi-center design this study aims~     to proof the influence of an individualised endurance training program by bicycle ergometer~     performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary~     goals are to enhance physical performance, physical and mental well-being, and to improve~     measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A~     positive impact of physical activity was observed in adults on HD, although most studies did~     not address this issue in a randomised protocol. Despite this beneficial evidence in adults,~     sport is still not integrated as part of standard care in patients on maintenance HD. The~     study protocol, developed in close collaboration with the German Sport University Cologne,~     differs substantially from previously published reports as it uses bicycle ergometer~     training in an upright position outside the dialysis couch and adapts the intensity of~     intervention to the patient's capabilities. Based on the expected results the investigators~     will develop an individualised training program to be integrated in the standard care of~     (pediatric) patients on maintenance HD.~   "
114222|NCT01561105|"~     Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to~     Collaborative Treatment(IMPACT) collaborative care management program for late-life~     depression.~   "
114223|NCT01561092|"~     Growing international scientific evidence has indicated a positive effect of SSRI treatment~     (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to~     conduct a prospective randomised double blind placebo-controlled multicenter study of the~     combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion~     of the SERT (serotonin transporter) gene may influence this treatment effect and may in~     itself be a risk factor for stroke, an aspect we also wish to explore.~      Hypotheses:~        1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new~          thromboembolic events and leads to better rehabilitation.~        2. A specific SERT genotype is associated with an increased risk of first ever stroke.~        3. A specific SERT genotype is associated with a higher risk of post stroke depression.~      600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1~     ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6~     months. During these 6 months there will be 2 clinical follow up visits, one telephone~     control and one visit to evaluate compliance regarding medication. Patients who had an MRI~     as a part of the routine investigations done upon admission (approximately 300 patients)~     will have a control MRI after 6 months.~      Additionally 400 patients, not eligible for participation i the randomised controlled trial,~     will be genotyped and answer questionnaires after 1 and 6 months.~   "
114224|NCT01561079|"~     This research will track the longitudinal neurobehavioral development of the~     buprenorphine-exposed fetus across gestation through 1 month of age in an effort to~     determine the safety of this medication for use during gestation, the relationship between~     maternal physiologic changes due to buprenorphine administration and newborn functioning,~     and to determine potential fetal neurobehavioral markers that may predict Neonatal~     Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results~     from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to~     advance the way the investigators inform the treatment of the opioid dependent woman during~     pregnancy and her infant after birth.~   "
114225|NCT01561066|"~     Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output~     enterocutaneous fistulas. However, there are only few studies that report autologous glue~     application in a larger patient group or clinical-controlled studies in this setting. The~     aim of this study was to investigate the efficacy and safety of autologous platelet-rich~     fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with~     conservative management without the use of adjuvant application of FG into the fistulous~     tract.~   "
114226|NCT01561053|"~     The purpose of this study is to evaluate the changes in the cognitive, functional,~     behavioral and global domains based on the different applicable psychometric batteries and~     scales.~   "
114235|NCT01560936|"~     The purpose of this study is to determine the contamination rate of the parents cell phone~     in a newborn intensive care setting and identify the types of bacteria contaminating the~     cell phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the~     transmission of bacteria from the cell phone to the parents hands.~   "
114236|NCT01560923|"~     This is a randomized, double blind, multi-institutional phase II therapeutic study of~     Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in~     men with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration~     resistant (hormone refractory). Patients are randomized to receive either twice daily oral~     Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T~     infusion.~   "
115053|NCT01550185|"~     The purpose of this study is to find out the highest safe dose and examine the side effects~     and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML)~     treated with chemotherapy that have not responded to previous therapy or have suffered a~     relapse~   "
114227|NCT01561040|"~     Dry eye disease (DED) is a common but often inadequately treated disease of the tears and~     surface of the eye. It can cause poor vision and chronic pain and is more frequent with~     increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical~     Trials in Dry Eye defined dry eye as a disorder of the tear film due to tear deficiency or~     excessive evaporation, which causes damage to the interpalpebral ocular surface and is~     associated with symptoms of ocular discomfort. The International Dry Eye Work Shop (DEWS)~     committee subsequently defined dry eye as a multi-factorial disease of the tears and ocular~     surface that results in symptoms of discomfort, visual disturbance, and tear film~     instability with potential damage to the ocular surface. It is accompanied by increased~     osmolarity of the tear film and inflammation of the ocular surface. Typically, symptoms~     associated with dry eye disease include ocular burning, foreign body sensation (sand or~     grit), photophobia (light sensitivity), and other symptoms that result in overall long term~     discomfort in patients. The proposed eight week feasibility study if dry eye subjects~     confirmed elevated osmolarity and symptoms respond to nutritional therapy.~   "
114228|NCT01561027|"~     The study is a randomized, double blind, cross-over study to evaluate the safety and~     efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.~   "
114229|NCT01561014|"~     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride~     when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone~     after surgery in treating patients with locally advanced cancer of the esophagus and~     gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib~     hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after~     surgery may kill any tumor cells that remain after surgery~   "
114230|NCT01561001|"~     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous~     humor via the trabecular meshwork towards the systemic circulation. This may lead to an~     increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to~     lower IOP in order to prevent progression of the optic neuropathy and subsequent visual~     loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP~     remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP,~     surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a~     non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the~     enhancement of the aqueous outflow. This forms the rationale to conduct this prospective,~     open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in~     patients with POAG before and after DSCI.~   "
114231|NCT01560988|"~     This study plans to look at whether borage and echium seed oils (natural oils from two~     plants) help decrease asthma symptoms and affect cells involved in inflammation. The~     investigators also want to look at how these plant oils decrease the generation of~     inflammatory cells in people with asthma.~   "
114232|NCT01560975|"~     Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in~     the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common~     sleep-related breathing disorder and is characterized by repeated partial or complete upper~     airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the~     diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called~     respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous~     positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The~     association between OSAS and glaucoma has been extensively studied, although a few reports~     have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading~     to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic~     neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure~     (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.~      The purpose of this study is to investigate how IOP varies in time, particularly during~     sleep in OSAS patients with or without glaucoma, and if the IOP variations are associated~     with the use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a~     portable investigational device using a contact lens sensor that monitors the IOP~     fluctuation continuously over 24-hours.~   "
114233|NCT01560962|"~     Objective: To determine the preliminary outcome of external over the counter (OTC) povidone~     iodine (PI) application in the management of chronic and acute blepharitis vs. currently~     clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or~     antibiotic/steroid ointments.~      Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled~     and randomized into four groups.~      In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     twice daily for 10 days and the other eye with no intervention.~      In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive warm soaked eyelid wash.~      In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10~     days.~      In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI~     and the other eye will receive tobradex ointment applied to the lid margin.~      Subjective variables assessed included itchiness, foreign body sensation and eyelid edema~     (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland~     plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the~     initiation and at the cessation of treatment were obtained.~   "
114234|NCT01560949|"~     The goal of this clinical research study is to learn if a chemotherapy combination called~     modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation~     therapy, followed by surgery, can help to control pancreatic cancer. The safety of this~     treatment will also be studied.~      mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with~     gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer~     cell death.~   "
114237|NCT01560910|"~     Study design and objective The primary outcome of this prospective cohort study was to~     identify the endoscopic findings that have diagnostic value for the prediction of NERD~     (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to~     evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without~     minimal change esophagitis.~   "
114238|NCT01560897|"~     The aim of this pilot study is to evaluate the validity and reproducibility of a functional~     test Test C13 ureogenesis to measure in vivo, using the methodology Laboratory of~     Metabolic Diseases of Cliniques Universitaires Saint-Luc~   "
114239|NCT01560884|"~     The purpose of this trial is to study safety, tolerability, and phosphate binding capacity~     of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal~     failure. Renal excretion of phosphate is expected to decrease and fecal excretion of~     phosphate is expected to increase after treatment.~   "
114240|NCT01560871|"~     Patients with chronic heart failure need a safe and effective exercise program that will~     improve their quality of life. For this study, we will determine if adult chronic heart~     failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle~     Training (IMT) program will have an additional beneficial effects on respiratory muscle~     strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate~     variability, and physical activity level compared to subjects who are assigned to the home~     walking and sham Inspiratory Muscle Training (IMT) program.~   "
114241|NCT01560858|"~     The purpose of the protocol is to describe treatment patterns among patients with prostate~     cancer prior to diagnosis of castration-resistant state.~   "
114242|NCT01560845|"~     In recent years, the safety and efficacy of autologous bone marrow stem cells infusion~     (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone~     marrow stem cells (ABMSC) through inserting a catheter into right gastric artery as far as~     proper hepatic artery after finishing open abdominal portal hypertension surgery. The~     present study was designed to treat bleeding from esophageal varices and hypersplenism and~     hopefully to improve the liver function as well.~   "
114243|NCT01560832|"~     Clostridium difficile is an important pathogen, causing disease that ranges from mild~     self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C.~     difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and~     for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two~     large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical~     illness. Primary risk factors for C. difficile clinically apparent infection include~     antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥~     65 years), and increased length of hospital stay. The incidence of CDI both in the hospital~     and the community is important in the understanding and characterization of the disease and~     its prevention. This observational, epidemiological study will advance the investigators~     understanding of CDI risk factors in several hospitals and possibly the community in the~     Asia Pacific region.~   "
114244|NCT01560819|"~     Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder~     affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2~     different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades,~     Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a~     treatment option for Clostridium difficile colitis and UC. The literature supports strong~     evidence for the plausibility of using GMT for patients with IBD associated colitis,~     especially for patients with UC.~      This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric~     gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to~     evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis~     (UC and CD with colonic involvement only) will be approached for GMT as a treatment option~     for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily~     on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be~     done at their regularly scheduled clinic follow up.~      Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family~     members and friends. Donors will be required to complete a screening questionnaire, provide~     medical history, and undergo blood and stool tests.~   "
114245|NCT01560806|"~     A quasi-experimental study design was chosen to compare the model of hypertension management~     at commune-level with conventional management for people with high blood pressure in two~     communes (one for intervention versus one for reference).~      A intervention model included the commune-based programme on hypertension management~     combined with comprehensive health promotion campaigns~   "
114246|NCT01560793|"~     This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a~     recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range~     of doses.~   "
114247|NCT01560780|"~     This is a randomized-controlled clinical trial that will randomize 120 patients undergoing~     clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg~     daily or matching placebo for 12 months, starting at the time of hospital dismissal from~     surgery. The primary goal of the study is to determine whether prasugrel administration will~     prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by~     optical coherence tomography.~   "
114248|NCT01560767|"~     Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac~     30mg reduces postoperative pain following primary total knee replacement compared with the~     current standard treatment of femoral nerve blockade.~   "
114249|NCT01560754|"~     The primary objective of this study is to demonstrate that transdermal nicotine treatment~     retards disease progression as measured by change in total Unified Parkinson's Disease~     Rating Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study~     treatment plus two more months wash out (60 weeks).~   "
114276|NCT01560403|"~     This study is a 1-year open label extension study to collect long term efficacy and safety~     data from patients who have completed approximately 2 years of dosing in Study CL0600-021.~   "
114277|NCT01560390|"~     The aim of the study is to evaluate the impact of ketamine associated to an opioid for~     sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be~     drive by nurses according to an algorithm. The investigators will evaluate the quantity of~     opioates used in each arm and the safety of ketamine.~   "
114250|NCT01560741|"~     The critical nature of respiratory diseases, the continuously increasing prevalence of these~     conditions, and the subjective perception of patients vis-à-vis their pulmonary function and~     health status underscore the importance of home telemonitoring. These conditions are~     critical and necessitate close and regular monitoring that may be achieved at distance using~     telemonitoring. This study will assess a number of measures both at baseline and~     post-intervention from a number of domains, including Arterial Blood Gases (ABG),~     BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life,~     patients satisfaction and utilization of healthcare resources.~   "
114251|NCT01560728|"~     Youth with mental illnesses are disproportionately represented in juvenile correctional~     facilities and limited evidence exists about effective treatments in this setting. This~     study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to~     be efficacious in community settings, to the correctional setting and study the feasibility~     of its implementation. Conducted within Texas youth correctional facilities, the findings~     will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to~     meet the unique needs of incarcerated youth and the correctional system, one of the~     priorities outlined in the National Institute of Mental Health Strategic Plan.~   "
114252|NCT01560715|"~     The purpose of this study is to evaluate the short-term safety and efficacy of a single~     intravitreal injection of autologous bone marrow stem cells in patients with retinitis~     pigmentosa.~   "
114253|NCT01560702|"~     Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.~   "
114254|NCT01560689|"~     The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective~     in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.~   "
114255|NCT01560676|"~     Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills~     training delivered to high school students on BMI, nutrition and physical activity~     behaviors, and self-efficacy over 6 months.~   "
114256|NCT01560663|"~     Neoadjuvant (preoperative) chemotherapy is an interesting research tool which allows~     investigators to test new drugs and/or new schedules with a validated surrogate endpoint,~     pCR. It also represents an ideal model to evaluate the relationships between treatments and~     tumor biomarkers. Recent publications have shown that new molecular classifications of~     breast cancer (intrinsic subtypes) have an important prognostic and predictive value. Using~     microarrays for gene expression profiling seems to be the best way to perform this~     classification; nevertheless such assays are not optimally available for common clinical~     practice. The IHC-based classification systems are still useful, as fresh tissue is not~     normally available in clinical practice, and has been shown to correlate well with intrinsic~     classification using gene expression microarrays. Recently the PAM50 gene set provided a~     risk of relapse score not only in ER-positive, node negative patients (similarly to the~     Oncotype Dx Recurrence Score) but also in the ER negative disease. Additionally, the PAM 50~     assay was highly predictive of neoadjuvant response when considering all patients. This~     assay added significant prognostic and predictive value to pathologic staging, histologic~     grade, and standard clinical molecular markers while using an easy technique that can be~     performed in clinical practice because the qRT-PCR assay can be performed using FFEP tissue.~      Triple Negative Breast Cancer (TNBC) is defined by a lack of expression of ER, PgR and~     HER-2. DNA microarray profiling studies have led to the classification of invasive breast~     carcinoma into five subtypes: luminal A and B, normal breast-like, HER2/neu overexpressing~     and basal-like subtypes, with clinical implications. Later on, a new subtype, the~     claudin-low, has been described. Although not synonymous, the majority of TNBCs carry the~     basal-like breast cancer (BLBC) molecular profile.~      The triple negative subtype accounts for 11-20% of breast cancer in different studies,~     whereas in selected cohorts of patients with advanced breast cancer or African-American~     ethnicity, TNBC may be diagnosed among as many as 23-28%.~      Patients with TN breast tumors treated with standard chemotherapy have a shorter DFS and OS~     than non-TNBC, this difference have been shown to be independent from tumor grade, nodal~     status and treatment in some studies. The peak risk of recurrence occurs within the first 3~     years after initial treatment, with the majority of deaths occurring in the first five~     years.~      Chemotherapy remains the only systemic treatment option available for TNBC patients. Several~     studies have shown that TNBC/BLBC is associated with an increased response rate to~     neoadjuvant chemotherapy when compared with luminal tumors. However, TNBC patients have a~     significantly decreased DFS and OS in comparison with luminal patients. The largest study~     exploring response and survival in early stage breast cancer treated with neoadjuvant~     chemotherapy was reported by Liedtke et al. Although an increase pCR rate was observed among~     the TNBC patients, they had a shorter lifespan than the non-TN ones. Patients experiencing~     pCR had an excellent OS regardless of hormone receptor expression, but patients with~     residual disease had a significantly shorter survival associated with TNBC compared with~     non-TN ones. This demonstrates that poor OS is derived from chemo-resistant patients (what~     unfortunately represent > 50% of them).~      A relevant problem is the differential response to drugs of TN tumors. These tumors are~     usually treated with multidrug combinations including anthracyclines and taxanes, with pCR´s~     of 28-32%. Only recently, the results of a few small trials combining platinum salts and~     taxanes have been reported, with encouraging results (pCR of 44-77%). The taxane-platinum~     salt combinations have a biological background, since TN not associated BRCA1 mutations are~     sensitive to taxanes and resistant to anthracyclines and platinum salts are effective in TN~     tumors probably because a significant proportion of them have functional DNA repair~     deficiencies.~      The primary objective of the study is to identify predictors of response to~     docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined~     as lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR,~     pathological complete response).~   "
114257|NCT01560650|"~     The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid~     doses of 35 ml/kg/h is better, but the result is according to white people, black people .~     It is Whether the best amount of replacement fluid for Chinese people, it is unclear.~     Especially,there is little evidence about the optimal dose from randomized trials in Cardiac~     surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical~     situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14~     days, 28 days, 90 days survival and renal function.~   "
114258|NCT01560637|"~     This study is an international, multi-center, open-label study designed to provide oral~     treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have~     completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety~     of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.~   "
114259|NCT01560624|"~     This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C):~     placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial~     Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30~     days at randomization for their PAH. Study visits will occur in four week intervals for the~     first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to~     first clinical worsening event and the 6-minute walk test at Week 24. Study procedures~     include routine blood tests, medical history, physical exams, disease evaluation, and~     exercise tests. Patients who complete all required assessments will also be eligible to~     enter a long-term, open-label, extension study (TDE-PH-311).~   "
114260|NCT01560611|"~     In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain~     and heart are preserved while others (skin, gut and skeletal muscle) are being~     underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not~     clinically available but threatens end-organ perfusion and carries the risk of multi-organ~     failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the~     present study aims at detecting silent peroperative hypoperfusion episodes. The~     investigators hypothesize that gradient, measured during the surgical procedure, will~     predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate~     concentration, measured in intensive care unit.~   "
114261|NCT01560598|"~     We aimed to risk faoctors for GERD and association between visceral obesity, plasma~     adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy~     Koreans.~   "
114262|NCT01560585|"~     This is an open label study of isotretinoin, a medication which is FDA approved for~     treatment of other conditions to determine initial safety in Alzheimer's disease.~   "
114263|NCT01560572|"~     A prospective, open, randomized trial, in which the investigators aim to achieve optimal~     immunosuppression after renal renal transplantation with maximal reduction of side effects,~     especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies.~     Immunosuppression without steroids and CNI minimization is compared to standard~     immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.~   "
114264|NCT01560559|"~     Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and~     Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient~     in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as~     surgical myotomy but less invasive and more effective with less complications than~     endoscopic pneumatic dilation. Up to now, published studies have confirmed these~     expectations, with 100% efficacy and no clinically significant complications. The present~     clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary~     achalasia patients.~   "
114265|NCT01560546|"~     A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.~      Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by~     hyperinsulinaemia and insulin resistance.~      Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with~     low normal levels of bioavailable testosterone and type 2 DM.~   "
114949|NCT01551563|"~     The study aims at studying the outcomes of a protocol-based handling of newly diagnosed~     Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a~     descriptive study and no hypothesis is predefined.~      Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating~     purposes.~   "
114266|NCT01560533|"~     The project aims to understand better how patients live the event of cancer and live its~     consequences on their bodily representations. In the study, the dynamic of the body image is~     not restricted to appearance but include sensations and visions of the inner body, what~     explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and~     HIPEC.~      The three objectives of the study are:~        -  identifying the impact of the representations of the treated body on the psychological~          strategies to cope with the disease, the bodily changes and the prospects of life;~        -  making explicit the positive or negative impacts of these representations on the~          relationship between patients and health professionals (easing factors,~          misunderstandings, negotiations, etc.);~        -  associating the health professionals with the study in its course and evaluation in~          order to elaborate a methodological collaborative approach between patients, health~          professionals and researchers in social sciences.~   "
114267|NCT01560520|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of physical activity in stroke patients immediately after debut of symptoms~     and examination of both the biochemical aspects of physical rehabilitation as well as the~     optimal dose of physical rehabilitation is of great importance for many patients, their~     relatives as well as of a great socioeconomic importance.~      The purpose of the project is to describe the amount and pattern of physical activity in~     stroke patients in the first week after admission. The investigators hypothesis is that~     patients are inactive for most of the time during hospitalization, activity being correlated~     with severity of stroke, but not with age, BMI and sex.~   "
114268|NCT01560507|"~     The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using~     an adaptive treatment algorithm developed in previous clinical trials, in order to calculate~     cost-effectiveness of the treatment; 2) the relationship between genotype and response to~     cigarette smoking cessation treatment.~   "
114269|NCT01560494|"~     This study describes the development and validation of a structured training and assessment~     curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that~     residents trained using the STAC curriculum would demonstrate superior technical skills in~     the operating room compared to residents that were trained using a traditional curriculum.~   "
114270|NCT01560481|"~     Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the~     treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in~     naive patients with type 2 diabetes.~      The objective of this study is to evaluate the safety, tolerability and pK profile of~     Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single~     dose, in step A. In step A will be included 25 volunteers.~      In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin~     Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be~     included 24 volunteers.~   "
114271|NCT01560468|"~     This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver~     Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX~     5061 oral monotherapy will be safe in adults during and after liver transplantation and that~     therapy will also inhibit HCV infection of newly transplanted livers in adults with prior~     HCV infection.~   "
114272|NCT01560455|"~     This study will examine use of two-stent versus one-stent techniques for patients with large~     calibre bifurcation lesions including significant side branch disease.~   "
114273|NCT01560442|"~     The purpose is to study the relation between pupillary diameter measured under scotopic~     conditions, and the pain thresholds measured at the time of peak and residual effect of~     methadone/buprenorphine in opiate-dependent patients following a substitution program.~   "
114274|NCT01560429|"~     Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous~     epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural~     anesthesia (PCEA) is more effective but little research has compared the two methods~     following thoracotomy. The current randomized, prospective clinical investigation did just~     this. Following institutional ethics approval 52 patients scheduled for thoracotomy were~     recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter~     was sited preoperatively. Postoperatively all patients were titrated on continuous epidural~     infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at~     ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively~     determined randomization (either remained on continuous epidural infusion or they were~     switched to receive 2/3 of the stabilized background dose via continuous epidural infusion~     with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants~     remained on their allocated analgesic regimens for 48 hours postoperatively. The primary~     outcome was consumption of local anaesthetics/opioids. The secondary outcomes were worst~     pain and pain while coughing (0-10 NRS).~   "
114275|NCT01560416|"~     Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in~     other research studies and laboratory experiments. It has also been studied in phase I~     trials, where the appropriate dosing has been determined. Ganetespib is considered an HSP90~     inhibitor. By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells~     to become resistant to treatment.~      Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing~     so, it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a~     decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the~     FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the~     results of phase III clinical trials.~      In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It~     is not known whether this is true in humans. In this research study, we are evaluating the~     effect of the addition of ganetespib to fulvestrant in participants with hormone~     receptor-positive, metastatic breast cancer.~   "
114278|NCT01560377|"~     The purpose of this study is to demonstrate that NIR fluorescence angiography using the~     PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT System or PINPOINT) can assess~     viability of colon tissue during laparoscopic left colectomy. This information will provide~     the surgeon with clinically relevant information in assessing whether or not the tissue has~     adequate blood supply in the lower section of the colon prior to a colectomy.~   "
114279|NCT01560364|"~     This is a prospective observational clinical multicentric study in ICU with acute renal~     failure requiring renal replacement therapy.~   "
114280|NCT01560351|"~     The aim of this study is to evaluate the effect of repeated low-frequency Transcranial~     Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with~     gambling cues, on gambling craving. Participants are pathological gamblers. A single real~     stimulation and a single shame stimulation are administered in a random order for each~     participant (cross-over study).~   "
114281|NCT01560338|"~     The purpose of the study will help us understand the complex interaction between hypothermia~     (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their~     impact on how routinely given sedation drug are broken down and used by the body when given~     to children after cardiac arrest (when heart stops pumping blood) and are critically ill.~   "
114282|NCT01560325|"~     A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection~     on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy.~     The usefulness of the this regimen is evaluated by response rate, progression free survival~     and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.~   "
114283|NCT01560312|"~     Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic.~     Patients with refractory hypertension will be randomized in 1:1 manner either to renal~     denervation plus optimal medical antihypertensive treatment without spironolactone or to~     antihypertensive treatment alone including spironolactone if not contraindicated. The~     primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline~     and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is~     120 patients. Patients follow-up is planned for 3 years.~   "
114284|NCT01560299|"~     Iodine therapy is the best treatment for graves disease.Most patients receive methimozale~     prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.~      Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and~     others prefer longer off - methimazole period which bothers most patients. This study aimed~     to evaluate optimum time for methimazole discontinuation in graves disease.~   "
114285|NCT01560286|"~     The primary objective of the study is to evaluate the effect of dosing regimens of multiple~     subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while~     decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.~   "
114286|NCT01560273|"~     The purpose of this clinical investigation is to evaluate the clinical outcomes of subject~     with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™~     Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry~     Disability Index (ODI) improvement and success of fusion.~   "
114287|NCT01560260|"~     This phase II trial studies how well linsitinib works in treating younger and adult patients~     with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
114288|NCT01560247|"~     To determine the revascularization rate, clinical efficacy and safety of the CE-marked~     MindFrame System in ischemic stroke patients~   "
114289|NCT01560234|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of single ascending doses of AZD8848 in healthy subjects.~   "
114290|NCT01560221|"~     The combination of using injection drugs, smoking crack cocaine, having multiple sex~     partners, and inconsistent condom use results in substantial risk for acquiring and~     transmitting HIV, and many drug dependent adults who have been arrested on charges of~     prostitution fit this profile. Existing interventions for reducing HIV risk have had limited~     efficacy in drug-dependent sex workers, and criminal justice approaches have been~     ineffective despite their high cost. A potentially ideal alternative is to divert~     drug-dependent arrestees from prosecution to a treatment that reduces drug use and HIV sex~     risk behaviors, while providing job skills training and promoting community employment to~     alleviate the financial need to continue sex work. In order to provide an effective~     therapeutic alternative to criminal prosecution, the investigators propose to develop a~     multifaceted intervention that includes opiate agonist treatment (i.e., methadone OR~     buprenorphine) and the Therapeutic Workplace. The Therapeutic Workplace is a supported~     environment in which participants are required to provide drug-free urine samples to access~     paid job skills training or employment and to maintain the maximum rate of pay. The overall~     intervention is designed to reduce drug use and HIV risk behaviors, and simultaneously~     promote employment. The proposed project is a 2-year Stage I behavior therapy development~     effort that will include the development, manualization and pilot testing of a Therapeutic~     Workplace intervention tailored to drug-dependent adults arrested for prostitution. In the~     pilot study, the investigators will recruit opiate- and cocaine-dependent adults arrested~     for prostitution from the Eastside District Court in Baltimore. Eligible individuals will be~     offered methadone treatment in lieu of prosecution and will be required to remain in~     methadone treatment for 90 days to have the charges against them dropped. After enrolling in~     opiate agonist treatment, the diverted individuals will be invited to participate in the~     pilot study. Interested individuals will be randomly assigned to receive the standard opiate~     agonist treatment services or these services plus the Therapeutic Workplace. The Therapeutic~     Workplace has two phases. In Phase 1, participants will be offered four months of~     stipend-supported job training in the Therapeutic Workplace. In Phase 2, participants will~     be encouraged to seek employment in a community job and will receive wage subsidies for four~     months for maintaining community employment or engaging in supervised job seeking.~     Throughout both phases, participants will be required to provide drug-free urine samples to~     receive Therapeutic Workplace wages (training stipends in Phase 1 and wage subsidies in~     Phase 2). The wage subsidy program will include drug testing managed by a national supplier~     of drug-free workplace services. Overall, this treatment could serve as a novel and ideal~     intervention for drug-dependent adults arrested for prostitution while reducing criminal~     justice costs.~   "
114300|NCT01560078|"~     Tubercular pleural effusion is the second most common form of extrapulmonary tuberculosis~     (EPTB) seen in clinical practice after tuberculosis (TB) lymphadenitis. It is common that~     after complete treatment of the patient with tubercular pleural effusion with six months of~     the short-course chemotherapy under Directly Observed Treatment Short-Course (DOTS), pleural~     effusion has not resolved completely. In these cases treatment need to be extended for one~     or two more months by giving extension pouches.~      Since DOTS does not recommend demonstration of complete resolution of tubercular pleural~     effusion at the end of treatment completion, there is paucity of data in terms of the~     patients declared cure for the sputum negative pulmonary and extra-pulmonary TB as such~     which includes TB pleural effusion as well. This project aims to look into the patient~     characteristics, treatment outcome, and compute the number of cases which require an~     extended regimen and to what extent is the pleural effusion persistent at the end of six~     months of standard DOTS therapy.~   "
114291|NCT01560208|"~     Corneal diseases are a major cause of blindness worldwide, and corneal infections are a~     substantial cause of blindness in Asia. The aim of the Asia Cornea Society Infectious~     Keratitis Study (ACSIKS) is to study infectious keratitis (corneal infections) in Asian~     countries, so as to improve strategies for prevention and treatment, and to reduce the~     burden of blindness in Asia.~      The first phase of ACSIKS is an 18-month observational study involving 11 eye hospitals in 8~     Asian countries; these hospitals manage more than 6700 cases of corneal infections every~     year. From the first quarter of 2012, all patients with a corneal infection will be~     recruited and a standard ACSIKS protocol will be applied; this protocol includes the use of~     a common set of study forms and a suggested panel of microbiological examinations. However,~     each centre will be continue to treat their patients with the anti-infective therapy~     standard for their centre. Data will be recorded for each patient for a period of six~     months, including their medical and surgical management, the final clinical outcome and~     vision.~      Bacterial and fungal growths from patients will also be stored for further research during a~     second phase of ACSIKS. These studies will focus on evaluating the resistance of the most~     common bacterial infections to the current available antibiotics, performing DNA testing to~     compare our strains with bacterial infections in the West, and to developing new diagnostic~     tests and anti-infective therapies tailored to corneal infections in Asia.~   "
114292|NCT01560195|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase~     2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma~     half-life, and prolonged efficacy in compare with ﬁlgrastim. The purpose of this study is to~     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia~     following chemotherapy in patients with advanced NSCLC.~   "
114293|NCT01560182|"~     This is a phase I/II protocol aiming at the assessment of the safety and efficacy of ARSA~     gene transfer into hematopoietic stem/progenitor cells for the treatment of Metachromatic~     Leukodystrophy.~   "
114294|NCT01560169|"~     This is an evaluation of celiac-specific patient reported outcome instruments in celiac~     disease patients.~   "
114295|NCT01560143|"~     If tigecycline clearance increases with body size then serum exposure values will be lower~     in obese class III compared to normal weight subjects because exposure changes inversely~     with clearance when the dose is fixed without regard to weight.~   "
114296|NCT01560130|"~     Behavioral weight loss programs can successfully reduce body weight, but these programs are~     available to limited numbers of overweight and obese individuals. This project evaluates a~     unique weight loss approach that combines a self-sustaining weight loss campaign (for~     outreach) with training in behavioral weight loss strategies and tests the efficacy of~     adding components designed to enhance accountability and increase motivation for weight~     loss.~   "
114297|NCT01560117|"~     Immunotherapy with the monoclonal anti-CD20 antibody rituximab has become standard of care~     for patients with follicular lymphoma. However, there are still open questions regarding~     dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners~     during induction as well as the best interval and length of rituximab maintenance treatment.~     Fludarabine-mitoxantrone combinations have shown strong debulking activity as initial~     therapy followed by rituximab maintenance. While rituximab maintenance with a standard dose~     of 375 mg/m2 prolongs clinical remissions, administration schedules still vary:~     Three-monthly infusions for 2 years and two-monthly infusions for one or 2 years are most~     frequently used. A few pharmacokinetic data for rituximab have been reported for induction~     treatment. These studies have proposed a presumptive active level of 25.000 ng/ml in~     anti-lymphoma treatment. However, there is only limited information regarding maintenance~     treatment in patients who are in remission and have no remaining tumor load.~      The aim of this trial is to investigate the effect of treatment with oral Fludarabine,~     Mitoxantrone und Rituximab and Rituximab maintenance on the depth of remission measured by~     BCL2/IgH PCR.~   "
114298|NCT01560104|"~     A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin~     and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated~     Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).~   "
114299|NCT01560091|"~     Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown~     to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a~     new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific~     receptors on the ureter. The investigators would like to see if there is some benefit to~     taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to~     break kidney stones in terms of allowing the ureteral fragments to pass through the ureter.~     Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of~     allowing stones to pass, but may allow them to pass more quickly because of the rapid onset~     of action.~      The side effect profile for both drugs is quite similar and tolerable. Patients may~     experience some common side effects associated with tamsulosin, including abnormal~     ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness).~     Serious reactions include orthostatic hypotension, syncope (fainting), and priapism~     (prolonged undesired erection).~      Patients may experience some common side effects with both silodosin and tamsulosin~     including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache.~     Serious side effects are rare and include orthostatic hypotension, intra-operative floppy~     iris syndrome, syncope, and priapism.~      Patients will experience the discomfort normally associated with kidney stones. All efforts~     will be made to alleviate these discomforts, including the use of the study medications.~     Patients will be able to take their routine prescribed pain medications, and will be asked~     to keep a record of their pain medication use.~      The investigators will be randomly enrolling patients from all racial backgrounds and of~     both genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no~     prior treatment for the study.~      The primary endpoint of this study is the clearance rate of kidney stones. That is, in what~     period of time does the patient achieve clearance, is stone free and has all residual stones~     gone. The secondary endpoints of this study include analgesic use, residual stones~     remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the~     need for hospitalization.~   "
114320|NCT01559818|"~     Patients who were previously enrolled in Study IMM-101-001 and who provide informed consent~     will be eligible to participate in this study.~      Once eligibility is confirmed, a full medical history covering the period from their~     completion of Study IMM-101-001 to date will be taken.~      The treatment regimen with IMM-101 will be one dose given every 4 weeks or as close to this~     interval as permitted due to practical or logistic considerations. The dose interval may be~     modified at the discretion of the Investigator provided the minimum period between doses in~     no less than 14 days.~      The overall objective is to determine the long term safety profile of IMM-101 administered~     intradermally for extended use.~   "
114950|NCT01551550|"~     This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the~     thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt~     tube exposure in patients undergoing glaucoma drainage device implantation.~   "
114301|NCT01560065|"~     Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates~     (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules~     is higher than in serum and it was increasing during the movement through the epididymis and~     the deferent duct. In the present study, the role of myo-inositol has been investigated as a~     possible antioxidant agent for the systemic treatment of male infertility and the~     improvement of the sperm's quality.~      Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF~     cycle: healthy subjects and subjects with oligoasthenospermia (OA, < 15 mil/ml). The~     collected samples were submitted to optic microscopy in order to evaluate semen's volume,~     spermatozoa's number and motility, during the initial semen analysis and after density~     gradient separation method; these parameters were evaluated before and after the~     administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three~     months.~      These values were compared with samples of seminal fluid of healthy patients undergoing to a~     IVF cycle for a female cause of infertility (control group).~   "
114302|NCT01560052|"~     This study will evaluate the long-term efficacy and safety of low dose oral~     methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor~     therapy, in preventing kidney events in patients with IgA nephropathy and features~     suggesting a high risk of progression.~   "
114303|NCT01560039|"~     Chronic neuropathic pain is a global health concern, affecting millions of patients~     worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic~     challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful~     analgesics combined with different classes of drugs that change nerve cell membrane~     properties. However, response to pharmacotherapy is often poor and mandates interventional~     strategies. Among the latest and most promising interventional strategies is the use of~     neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor~     cortex stimulation , both invasive and noninvasive (using megnetic or electical~     stimulation), has emerged as a highly beneficial treatment, and is currently included in~     different professional guidelines for the treatment of medically refractory neuropathic~     pain.~      A possible alternative way to achieve stimulation of the motor cortex is by using EEG based~     neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the~     patient to voluntarily modulate the activity of a circumscribed brain area after a few~     training sessions. While EEG based neurofeedfback is decades old, it has never been tested~     in neuropathic pain patients.~      This experiment is intended to compare both the clinical effects and the brain correlates of~     a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a~     population of patients suffering from chronic neuropathic pain of an upper limb. 15 such~     patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of~     M1 as described in the literature. A further 30 patients will be divided into two groups: 15~     will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity~     and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline~     chronic pain levels and their response to acute painful stimuli will be clinically evaluated~     before and after the course, and for an additional 1 month. Furthermore, before and after~     the course patients will be scanned using functional MRI during rest (baseline pain levels)~     and during acute pain. These scans are performed both to describe the neural correlates of~     the analgesia induced by motor cortex magnetic stimulation , and to compare the observed~     networks to the network effect of a BCI neurofeedback modulation of motor cortex activity.~   "
114304|NCT01560026|"~     Endometrial cancer is one of the most common female malignancies in the United States, and~     has increased in incidence in Taiwan in recent decades.A recent population-based analysis~     noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore~     it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment~     of endometrial cancer results in surgical menopause and places patients at risk for the~     long-term sequelae of estrogen deprivation. The goal of this study was to determine the~     frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian~     preservation in women with treatment for endometrial cancer.~   "
114305|NCT01560013|"~     Alcohol dependence is a major health problem worldwide and recently in Israel and it has~     major health care costs. Cannabis dependence is also a major health issue and many cannabis~     users find it difficult to quit. Similar to dependence on heavy drugs, alcohol and~     cannabis-dependent patients find it difficult to quit drinking and smoking cannabis and they~     relapse to drinking alcohol and using cannabis during treatment. Craving for alcohol and~     cannabis and withdrawal during detoxification are major factors for relapse to drinking and~     using cannabis. The cue-exposure and priming paradigms have been used in order to induce~     craving for alcohol and cannabis in the laboratory. Several studies have delineated the~     brain mechanisms responsible for cue-induced craving for alcohol using functional Magnetic~     Resonance Imaging (fMRI), a method that can be useful in monitoring progress of treatment. A~     proven useful medication for treatment of alcohol dependence is the opiate antagonist~     naltrexone commonly used for treatment of opiate dependence. We have found that~     cannabis-dependent patients in treatment for cannabis dependence who also were heavy users~     of alcohol have dropped early from treatment.~   "
114306|NCT01560000|"~     The objective of this study is to determine the satiety value of different bran fibers on~     appetite & subsequent food intake with acute consumption. Satiety will be measured~     subjectively by visual analogue scales (VAS).~   "
114307|NCT01559987|"~     The purpose of this research study is to investigate water flow in dental devices and to~     understand the function of water flow behind oral hygiene improvements. Understanding this~     mechanism may help with the design of future products.~   "
114308|NCT01559974|"~     The purpose of this study is to determine whether the intake of Vitamin D has a positive~     effect on walking ability of patients with peripheral artery occlusive disease. Skeletal~     muscle fibers change morphology in peripheral artery occlusive disease. In patients with~     Vitamin D-deficiency there are also changes of skeletal muscle fibers. The investigators~     have the hypothesis that patients with peripheral artery occlusive disease with subsequent~     changes of muscle fibers morphology of calf muscles might take profit of the administration~     of Vitamin D in combination with training.~   "
114309|NCT01559961|"~     The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in~     women with interstitial cystitis/bladder pain syndrome.~   "
114321|NCT01559805|"~     The study involves delivering one of two interventions - either Promoting Action Towards~     Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men~     (MSM) who have recently been diagnosed with HIV and assessing whether participants who~     received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of~     care and adherence to treatment, and engage in less sexual HIV transmission risk behavior~     than participants who received PCC.~        -  PATH consists of two preliminary sessions plus booster sessions after 1, 3, and 6~          months.~        -  Personalized Cognitive Counseling consists of one session.~      Participants will complete assessments before participating in their intervention (i.e., at~     baseline) and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be~     measured at approximately 6 and 12 months following baseline.~   "
114310|NCT01559948|"~     The purpose of this randomized clinical trial is to examine the usefulness of the addition~     of a pelvic compression belt to a lumbopelvic stabilization program for patients with~     sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic~     compression belt to lumbopelvic stabilization exercises alone. Outcome measures including~     the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and~     IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound~     imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall~     perceived improvement using the Global Rating of Change (GROC) scale will be collected.~     Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the~     compression belt in addition to the lumbopelvic stabilization program as compared to those~     who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for~     the deep abdominals as well as the GROC scores will be higher for those who receive the~     compression belt in addition to the lumbopelvic stabilization program as compared to those~     who receive the lumbopelvic stabilization alone.~   "
114311|NCT01559935|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     new drug called carfilzomib, in combination with dexamethasone in subjects with newly~     diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin~     (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) [BiRD] then lenalidomide~     alone.~   "
114312|NCT01559922|"~     The purpose of this study is to determine whether Artefill is safe and effective for the~     correction of atrophic facial acne scars.~   "
114313|NCT01559909|"~     Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a~     socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated~     limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and~     function. To date, there is no evidence to support whether VAS alters balance, kinematics,~     and kinetics when walking for TF amputees as compared to conventional socket suspension~     technology. Further, there is question regarding what the optimal height of the socket~     should be to maintain stability and function. So long as stability is not sacrificed, it may~     be advantageous to lower the height of the socket to allow full hip motion and improve~     sitting comfort. The purpose of this investigation is to assess if the socket height alters~     the motion of the leg and changes the way one walks when using VAS compared to conventional~     socket suspension technology. In this study, TF amputees will be fitted with a VAS socket~     that will be attached to their current prosthesis using similar alignment. Individuals will~     be assessed while walking on a level floor and during stair negotiation while wearing the~     prosthesis with the VAS socket at various socket heights as well as their current socket.~     Additionally, balance and socket standing and sitting comfort will be investigated.~   "
114314|NCT01559896|"~     The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are~     at increased risk of developing long term micro- and macrovascular complications. Subjects~     with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral~     glucose load. These subjects have a markedly increased risk of later T2DM development.~      T2DM development can be prevented or delayed by lifestyle modifications. To support~     lifestyle changes and reduce the risk of T2DM development, foods containing functional~     ingredients are being developed. An interesting functional ingredient is protein~     hydrolysate. An egg protein hydrolysate has been experimentally shown to improve endothelial~     function, to inhibit plasma angiotensin converting enzyme (ACE) and to reduce blood pressure~     in rats. Egg protein hydrolysate could thus be a interesting ingredient to treat the~     cardiovascular dysfunction associated with T2DM. In the present study, the effects of egg~     protein hydrolysate will be evaluated in subjects with overweight or moderate obesity and~     IGT or T2DM.~   "
114315|NCT01559883|"~     The study aims to document the flow of German patients with cancer and acute deep vein~     thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures,~     and therapy modalities.~   "
114316|NCT01559870|"~     The purpose of this study is to create a model using intra-operative modified SOFA score and~     peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit~     (CICU) for adult cardiac surgery with heart-lung machine~   "
114317|NCT01559857|"~     The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can~     cause changes in mood in some depressed patients. Study participants receive assessment of~     their cognitive and metabolic functioning.~      If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a~     90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting~     insulin and glucose levels, as well as routine blood testing.~      The investigators hope to quantify the role of Pioglitazone in patients with mood disorders~     and compare the values to those previously obtained in a healthy age-matched control~     population. The investigators also hope to examine the association between IR and cognitive~     performance and clinical course of depression in patients with mood disorders.~   "
114318|NCT01559844|"~     The primary objective is to determine if the administration of a combination of sofosbuvir~     (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular~     carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could~     prevent post-transplant re-infection as determined by a sustained post-transplant~     virological response (HCV RNA < LLoQ) at 12 weeks post-transplant.~      Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants~     enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to~     an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48~     weeks in the pretransplant treatment will have a second baseline at Week 24 for combined~     analysis in the pretransplant retreatment phase.~      Participants who undergo liver transplant will stop all study drug 24 hours prior to~     transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.~   "
114319|NCT01559831|"~     IC51-319 is a single-arm, open-label study that investigates immune responses in subjects~     undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during~     primary immunization.~   "
114345|NCT01559493|"~     Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of~     coronary artery stenosis severity in routine practice~        -  To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous~          coronary intervention (PCI).~        -  To investigate the influence of hyperemia on iFR.~        -  To test reproducibility of iFR and FFR.~   "
114322|NCT01559792|"~     The investigators want to study the changes in secretion of gastrointestinal hormones,~     absorption and metabolism of food and liquids before and after gastric bypass and in~     patients who are gastric banded but are getting conversion to a gastric bypass. All patients~     are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption~     of food is faster after gastric bypass and the secretion of gastrointestinal hormones~     change.~   "
114323|NCT01559779|"~     The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric~     bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as~     well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a~     bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to~     cause remission of type 2 diabetes shortly after the operation, before any significant~     weight loss. The altered transit of nutrient through the gastrointestinal tract after the~     operation is thought to play a key role in this remission and studies have shown significant~     changes in the secretion of gut hormones, namely the incretin hormone glucagon-like~     peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic~     islets as well as the stimulatory effect of the incretin hormones is changes~     postoperatively.~   "
114324|NCT01559766|"~     Vitamin A deficiency remains a major public health problem in developing country worldwide.~     Young Children are considered to be at greatest risk of deficiency. However, there is little~     information on the vitamin A requirement of Chinese children. In the present study, about~     400 children aged between 4 and 9 years old in a kindergarten and an elementary school of~     Shiyan City were screened before admission by questionnaire and anthropometric measurement.~     The vitamin A status of children was assessed by serum vitamin A level, relative dosage~     reaction and stable-isotope dilution technique. At the same time, their dietary vitamin A~     intakes were estimated by weighted-food dietary survey. The dietary vitamin A requirement in~     young children was determined on the basis of dietary vitamin A intakes in Children with~     adequate vitamin A level.~   "
114325|NCT01559753|"~     The duration of treatment of community acquired pulmonary infection varies between 5 and 14~     days according to the authors (22), or even 3 days with new drugs having long half-life (2).~     For nosocomial pulmonary infection, treatment durations are not standardized (5). It is~     simply mentioned the concept of usual treatment of at least 15 days. However, recent~     studies used 10 days of treatment without significant decrease in the rate of healing~     compared to usual treatment. It is essential to clarify the optimal duration of antibiotic~     treatment. Indeed, any excessive extension of treatment may increase the occurrence of~     adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to~     antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and~     an increase in the cost of treatment~   "
114326|NCT01559740|"~     After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may~     experience some amount of pain in the post-operative period. As part of the anesthesia~     technique, the investigators routinely provide a nerve block done on the abdominal wall that~     will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP~     block. The purpose of this study is to determine if the nerve block performed with local~     anesthetic solution using a regular concentration solution vs. a diluted solution may offer~     different durations of pain relief.~   "
114327|NCT01559727|"~     The purpose of this study is to examine the efficacy of three doses of prednisone, a~     glucocorticoid, in treatment of patients with symptomatic heart failure.~   "
114328|NCT01559714|"~     Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical~     Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical~     HCM).~      Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and~     pre-clinical HCM patients.~   "
114329|NCT01559701|"~     Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low~     Back Pain Or Osteoarthritis~   "
114330|NCT01559688|"~     Service members and veterans often experience symptoms of psychological trauma following~     combat deployments. While efforts are being made in the military and at the Veteran's~     Affairs to meet the large number of soldiers and veterans experiencing symptoms of~     psychological trauma, there remains a need to evaluate new treatments, particularly those~     that are designed to be brief in length.~      A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological~     therapy that is designed for rapid resolution of symptoms of psychological trauma. This~     approach uses a combination of talking and sets of eye movements guided by the therapist.~     During therapy, this interactive personal guidance is thought to be helpful in resolving~     problems (such as bad memories).~      The purpose of this study is to:~        1. Evaluate how effective ART is in treating symptoms of psychological trauma among~          non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring~          Freedom in Iraq and in Afghanistan or other combat conflicts.~        2. Learn if there is improvement in symptoms of psychological trauma (such as bad~          memories, anxiety, depression, and guilt) after receiving Accelerated Resolution~          Therapy (ART).~   "
114331|NCT01559675|"~     The purpose of this study is to evaluate the effect of low dose versus high dose steroids~     vital signs of patients currently on steroids or recently treated with steroids undergoing~     major colorectal surgery. The investigators hypothesize that there will be no statistically~     significant difference in orthostatic hypotension (blood pressure measured on lying,~     sitting, and standing), blood pressure, temperature or heart rate in the standard and low~     dose groups.~   "
114332|NCT01559662|"~     The Purpose of this study is to evaluate the effect of gum chewing on recovery of~     gastrointestinal function in patient undergoing major colorectal surgery. The investigators~     hypothesize that patients who chew gum after major colorectal surgery will have faster~     recovery of gastrointestinal function.~   "
114346|NCT01559480|"~     Endometriosis is one of the most common disease in reproductive aged women.Surgical~     intervention has a significant symptoms relief. However, symptom recurrence is often after~     surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in~     pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary~     outcome measurement is pain score at 6 months after surgery.~   "
114951|NCT01551537|"~     This PMS study aims to collect safety and reactogenicity data of Cervarix in the local~     population as per the licensing requirement of the Sri Lankan regulatory authority.~   "
114333|NCT01559649|"~     Stroke is a major medical problem in the United States, and veterans are at significant risk~     given that the most critical risk factors of stroke, older age and associated medical~     problems such as high blood pressure, are common. Dysphagia, swallowing problems, can lead~     to aspiration which in turn may result increased pneumonia, particularly in stroke patients.~     Development and implementation of an accurate and consistent nursing swallowing screening~     tool to identify risk of aspiration in individuals admitted with suspected stroke is~     critical as it allows for immediate intervention, thereby reducing associated medical~     complications, length of stay, and healthcare costs. The availability of such screening~     tools, however, is limited. The primary objective of this study is to construct a reliable~     and valid swallowing screening tool to identify risk of aspiration in individuals admitted~     with suspected stroke.~   "
114334|NCT01559636|"~     Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have~     been eliminated since 1988, outbreaks continue to occur, and new tools are needed to~     accelerate eradication. One concern in this effort is that some populations have decreased~     immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased~     seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV)~     was recommended for use in immunization campaigns, and will likely replace tOPV in routine~     immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been~     studied.~      This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who~     reside in Nepal. The investigators conducted a prospective, interventional study that~     assessed immune response to bOPV among infants with and without diarrhea. Immune responses~     were compared among infants with and without diarrhea.~      This study will result in a better understanding of the factors that decrease the ability of~     some children to seroconvert to OPV and be protected from poliomyelitis infection.~   "
114335|NCT01559623|"~     The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma~     urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder~     symptoms, and to correlate these findings with cystoscopic and urodynamic findings.~   "
114336|NCT01559610|"~     The purpose of this study is to determine whether the guidelines preoperative performed by a~     nurse contribute to the recovery of the patient submitted to cardiac surgery compared with~     the guidelines for routine.~   "
114337|NCT01559597|"~     The purpose of this study is to determine the effectiveness, safety and feasibility of a~     tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a~     controlled temperature chain (CTC). The CTC is defined as the storage and transport of~     vaccines within a temperature range appropriate to the heat stability profile of TT vaccine.~     In this study vaccines are transported and stored in the cold chain up to district level.~     From district to beneficiary level vaccines are exposed to ambient temperatures during a~     limited period of time.~      In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For~     this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in~     the laboratory and compared to vaccines that have been maintained in cold chain. If all~     parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the~     strategy in CTC will be used.~      Only if the laboratory results are adequate, villages will be assigned to one of the~     vaccination strategies. All women between 14 to 49 years of age in the selected villages who~     fulfill the inclusion criteria will be invited to participate.~      In order to determine the baseline anti-tetanus protection, TT vaccination history will be~     collected from all participants using a standardized questionnaire. Women who have already~     received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood~     will be collected from all participants to later verify in laboratory the baseline~     protection.~      A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold~     chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the~     same strategy employed for the first dose. Finally, four weeks after the second dose, a~     blood sample will be collected from all participants who received two doses of vaccine. The~     serological responses will be compared in the group that received two doses of TT vaccine~     maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.~   "
114338|NCT01559584|"~     Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a~     strong component of autoimmune origin. It is characterized by non-scarring hair loss on the~     scalp or any hair-bearing surface.~      Various therapeutic agents have been described for the treatment of AA, but none are~     curative or preventive. The aim of AA treatment is to suppress the activity of the disease.~     Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well~     documented therapy for AA since 1978.~      A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two~     previous studies. Sessions were carried out once every 3 months, and a higher efficacy with~     more encouraging response rates in comparison to the conventional PUVA therapy has been~     documented. This assumed upper hand over the conventional PUVA might be due to increasing~     the amount of UV reaching the hair follicle cells and the surrounding inflammatory cells.~     Also it has been suggested that it might play a role as a powerful initiating agent of~     suppression through direct action at the DNA level. However, still the exact effect of this~     treatment has not been fully clarified.~   "
114339|NCT01559571|"~     The purpose of this study is to determine what factors influence the visual outcomes of~     infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.~   "
114340|NCT01559558|"~     The purpose of this study is to retrospectively review the impact of vaginal packing on the~     urodynamic studies, especially for urethral pressure profiles.~   "
114341|NCT01559545|"~     Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly~     in people who have taken potent antibiotics. When C. difficile multiplies within the colon,~     it produces two toxins that cause inflammation and resultant abdominal pain, fever and~     diarrhea. Current treatment of mild to moderate disease is with immediate release~     metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed~     a delayed release form of metronidazole to release just before the colon to increase the~     concentration of antibiotic in the colon to improve the effectiveness of metronidazole~     treatment and potentially to allow less whole body exposure to the antibiotic.~      This study will measure the amount of metronidazole in the blood and stool of patients with~     C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing~     the antibiotic as designed, immediately before the colon.~   "
114342|NCT01559532|"~     This is an observational study to analyze the influence of surgery duration and tourniquet~     time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total~     knee arthroplasty (TKA).~   "
114343|NCT01559519|"~     The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post~     tips hepatic encephalopathy'~   "
114344|NCT01559506|"~     The objective of this study is to determine whether the Air Barrier System (ABS) reduces~     airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior~     spinal procedures~   "
117214|NCT01521767|"~     A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two~     Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial~     Extended Release Capsules~   "
114347|NCT01559467|"~     Approximately half of patients with acute chest pain, a very common reason for emergency~     department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac~     cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The~     diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms,~     electrocardiographic changes, and increased serum cardiac specific biomarkers~     (high-sensitive troponin T). Although being very sensitive of myocardial injury, increased~     high-sensitive troponin T levels are not specific for myocardial infarction. Invasive~     coronary angiography is still the reference standard for coronary imaging in suspected~     non-ST-elevation myocardial infarction. This study investigates whether non-invasive imaging~     early in the diagnostic process (computed tomography angiography (CTA) or cardiovascular~     magnetic resonance imaging (CMR)) can prevent unnecessary invasive coronary angiography. For~     this, patients will be randomly assigned to either one of three strategies: 1) routine~     clinical care and computed tomography angiography early in the diagnostic process, 2)~     routine clinical care and cardiovascular magnetic resonance imaging early in the diagnostic~     process, or 3) routine clinical care without non-invasive imaging early in the diagnostic~     process.~   "
114348|NCT01559454|"~     Chronic pain patients are treated with prescription opioids and many exhibit opioid~     addiction. Currently, there are no evidence-based guidelines to better manage patients with~     chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and~     methadone treatment in these patients. The investigators hypothesize that both buprenorphine~     and methadone treatment will reduce pain and addiction behaviors and increase functioning in~     these patients.~   "
114349|NCT01559441|"~     Increased postprandial lipemia may increase the risk for cardiovascular diseases. An~     important mechanistic link between lipemia following a high-fat meal and adverse~     cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important~     to identify nutrients that can neutralize this acute vascular disturbance.~      The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could~     improve vascular activity during the postprandial phase.~   "
114350|NCT01559428|"~     Plant sterols and stanols (also called phytosterols and phytostanols) are structurally~     related to cholesterol, but absorbed to a much lesser extent. Due to this structural~     similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower~     serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol-~     and stanol-enriched food products are therefore widely available on the market to lower the~     risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the~     formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are~     atherogenic. Although oxyphytosterols have been identified in human serum samples, the~     effect of an increased intake of plant sterols on serum oxyphytosterol concentrations in~     humans is not known. On the other hand, plant stanols cannot be oxidized and lower not only~     cholesterol absorption, but also plant sterol absorption.~      The major objective of the present study is to examine the effects of dietary plant sterols~     and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to~     investigate the effects of these products on postprandial serum oxyphytosterol~     concentrations.~   "
114351|NCT01559415|"~     Almost half of the Dutch population is currently characterized by overweight and obesity.~     Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight~     regain after weight loss: the yoyo-effect. The primary objective of this study is to~     investigate the association between the weight-loss-induced cellular stress response and the~     rate of weight regain. The secondary objective is to investigate the differences in cellular~     stress response and weight regain after rapid and slow weight loss. To investigate this,~     subjects will receive meal replacements replacing either all or part of the daily meals~     during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks~     while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week~     normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up~     period subjects will receive dietary advice according to the Dutch recommendations for~     healthy eating. The association between the amount of weight regain after the weight loss~     period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue~     metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress~     protein expression and gene polymorphisms in selected genes.~   "
114352|NCT01559402|"~     The study investigates if applying a special ventilatory strategy during anesthesia for~     laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of~     using 100 % oxygen during pre oxygenation and induction of anesthesia. The study~     investigates oxygenation with blood gas samples but also with a new method that might give~     more information without the use of blood gas samples.~      Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction~     and maintenance of anesthesia is performed with either a continuous positive airway pressure~     (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in~     comparison to a technique without CPAP but with a PEEP of 10 cm H2O.~      Secondary: The improved oxygenation during anesthesia can be prolonged inte the~     postoperative period if emergence from anesthesia is performed without high levels of~     oxygen.~   "
114353|NCT01559389|"~     Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI)~     and identify how treatment may improve the relationship.~   "
114354|NCT01559376|"~     The objectives of the study are two-fold:~        1. To determine the mean 5 year patency rate of the radial artery graft (Open vs.~          Endoscopic) of patients who have already had CABG surgery and who previously~          participated in the centre's RCT back in 2005-2007 using CTA and MPS-MIBI~        2. To determine patient quality of life at 5 years post CABG surgery~      It is hypothesized that the mean 5 year patency rate of the radial artery graft harvested~     endoscopically will be equal to or have greater patency than the radial artery graft~     harvested via the conventional/open technique. It is further hypothesized that patient~     quality of life will be similar amongst patients having had the open vs. endoscopic radial~     artery graft during CABG surgery.~   "
114355|NCT01559363|"~     The primary objective of this study is to determine the safety, plasma pharmacokinetics, and~     maximum tolerated dose (MTD) of KD019 when administered to subjects with ADPKD.~   "
115054|NCT01550172|"~     The purpose of the study is to determine whether a combined intervention of a night home~     monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in~     improving sleep in dementia caregivers who arise at night.~   "
114356|NCT01559350|"~     The ideal grafts for the right coronary artery system in coronary artery bypass surgery~     remain controversial. The objective of this study is to compare the long-term patency of a~     right gastroepiploic artery and a saphenous vein graft used for revascularization of the~     right coronary artery system in off pump coronary artery bypass surgery and to analyze the~     long-term clinical outcomes.~      Total 224 patients will be enrolled according to the randomization protocol.~      Check list~        1. Laboratories~        2. Quantitative coronary analysis (preoperative)~        3. Major adverse cardiac and cerebrovascular event~        4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years~          postoperatively~        5. Echocardiogram~      5. Cardiac enzyme~   "
114357|NCT01559337|"~     A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger~     pulp, which results in functional disability.The dorsal branch of the PDN can be transferred~     for reconstruction of such nerve defects.In this study, the investigators modified the~     Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for~     PDN defects. For comparison, the investigators collected a consecutive series of 32 patients~     with finger PDN defects treated using a traditional sural nerve graft from February 2005 to~     October 2008.~   "
114358|NCT01559324|"~     ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85~     years. There is limited evidence on the efficacy and cognitive side-effects of right~     unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered~     safe for the elderly. As far as the investigators know no randomized controlled trials~     (RCTs) have yet been published describing this population treated with BF or RU ECT.~     Non-demented depressed patients will be randomized to either method (n = 2x36). Symptom~     intensity, global cognitive function and biomarkers will be related to 20 healthy~     comparators. Testing, evaluation of depression and blood-tests are done before~     ECT-treatment, after a series of 6-16 ECT and 3 months after terminated ECT-treatment.~   "
114359|NCT01559311|"~     The purpose of this clinical project is to evaluate the efficacy of the presence of Right~     Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for~     bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection~     fraction (LVEF). The results of this project may provide with the evidence based medicine~     for guidelines expansion of using Cardiac resynchronization therapy (CRT) in patients with~     Heart Block and normal LVEF (LVEF >45%).~   "
114360|NCT01559298|"~     The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as~     antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the~     prevention of major ischemic events [myocardial infarction (MI), ischemic stroke] or death~     without increasing the risk of major bleeding events.~   "
114361|NCT01559285|"~     In this trial, the investigators intend to examine whether the concentration of local~     anesthetics during epidural analgesia could be modulating factor for change of hemodynamics~     in patients undergoing major upper abdominal surgery.~   "
114362|NCT01559272|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a~     paliperidone palmitate 3-month formulation in patients with schizophrenia.~   "
114363|NCT01559259|"~     This study will determine the overall analgesic efficacy of three different fixed dose~     ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.~   "
114364|NCT01559246|"~     The purpose of this study is to compare short term (up to 48 hours) traditional cardiac~     rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14~     days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA~     (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected~     cardiac arrhythmias.~   "
114365|NCT01559233|"~     Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides~     treatment procedures has grown dramatically over the past decade as new treatments and~     technologies have been introduced.~      This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus~     System, an innovative noninvasive system intended for wrinkles and rhytides treatment.~      Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months~     after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos~     were introduced to three uninvolved physicians for blinded evaluation.~   "
114366|NCT01559220|"~     The purpose of this clinical study is to investigate the safety and efficacy of deep brain~     stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and~     functional disability of Alzheimer's disease.~   "
114367|NCT01559207|"~     The main objective of this study is to evaluate, for 15 healthy volunteers and for 15~     patients with a history of venous thromboembolism (VTE), the monthly variation (over 6~     months) of plasma nucleosome and free DNA concentrations.~   "
114368|NCT01559194|"~     The primary specific aim of this study was to determine if overweight and obese~     premenopausal women can lose weight and if long term weight loss impacts biomarkers~     associated with breast cancer risk.~   "
114369|NCT01559181|"~     There is an increasing trend in the society for developing obesity, type 2 diabetes and~     cardiovascular diseases. It is therefore important to identify the risk factors behind this~     tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy~     (as in mothers with type 1 diabetes) may play a role in the development of obesity, type 2~     diabetes and cardiovascular diseases later in life for the children. Some studies suggest~     that high blood sugar levels during pregnancy can also affects cognitive function as well as~     growth and development of puberty. The mechanisms behind this are not sufficiently clarified~     yet.~      In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and~     information about the course of pregnancy was collected, including the long-term blood sugar~     level during pregnancy and the children's' condition at birth. The unique opportunities in~     Denmark to identify and follow the children of these mothers and the possibility to select a~     comparison group of children of non-diabetic mothers gives a unique opportunity to examine~     the children of mothers with type 1 diabetes and accurately investigate the effect of blood~     sugar levels in pregnancy on conditions later in life.~      There has not previously been made any study of this size and it is the investigators hope~     to be able to quantify the effect of blood sugar level during pregnancy on outcomes later in~     life. This will potentially give the possibility to detect individuals at risk for~     cardiovascular diseases earlier and to improve prevention targets in children of mothers~     with diabetes.~   "
114370|NCT01559168|"~     The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh~     over a 12 month follow up period, using a composite outcome including a good anatomical~     correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge)~     symptoms (answer no at question 3 of the PFDI-20) and no reintervention for recurrent~     prolapse of the anterior or apical compartment.~   "
114371|NCT01559155|"~     The primary objective of this study is to describe and compare plasmatic anti-proteasome~     auto-antibody concentrations among three distinct groups: (1) patients suffering from~     bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases;~     (3) an elderly control group.~   "
114372|NCT01559142|"~     The aim of the study is confirmation of efficacy of induction therapy with three doses of~     infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and~     safety of two regiment of maintenance therapy:~        1. Infliximab with immunomodulation~        2. Infliximab alone~   "
114373|NCT01559129|"~     The purpose of this first study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of pomalidomide (CC-4047) in the treatment of subjects with~     systemic sclerosis with interstitial lung disease.~   "
114374|NCT01559116|"~     The primary objective of the trial is to determine the 24-hour FEV1-time profile of~     tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks~     of treatment.~   "
114375|NCT01559103|"~     Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients~   "
114376|NCT01559090|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     pharmacodynamics of MEDI-546 in Japanese SLE patients.~   "
114377|NCT01559077|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.~   "
114378|NCT01559064|"~     This is a prospective, observational study of the volumizing effect of aesthetic use of~     Juvéderm VOLUMA® with lidocaine in the mid-face area.~   "
114379|NCT01559051|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the health of patients with human Chronic~     Obstructive Pulmonary Disease.~   "
114380|NCT01559038|"~     The current study will assess the real - life effectiveness of adalimumab in the management~     of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis~     (PsA).~   "
114381|NCT01559025|"~     The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the~     prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus~     newly diagnosis ( less than 6 months).~      The secondary objectives are:~        1. To define the immune and inflammatory profile~        2. To define the secretion of glucagon and GLP-1~        3. To assess the glycemic variability~   "
114382|NCT01559012|"~     CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the~     effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis~     Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a~     crossover design.~   "
114383|NCT01558999|"~     The purpose of this study is to assess the safety and effectiveness of SI-614 solution~     compared with placebo solution in treating patients with dry eye~   "
114384|NCT01558986|"~     This is a randomized, double blinded, placebo-controlled trial on the routine use of~     preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy~     of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI)~     in patients undergoing modified radical mastectomy (MRM) for breast care.~   "
114385|NCT01558973|"~     The purpose of this study is to explore whether frontal brain activation in response to~     stress varies as a function of the presence or extent of early trauma and whether or not~     this effect is greater in women compared to men. To examine the effect of stress on thinking~     and remembering. To examine the separate and interactive effects of stress, addiction,~     withdrawal, and genetics; and to examine fMRI brain activation associated with stressful,~     reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video~     clips in addicted individuals and in healthy controls.~   "
114386|NCT01558960|"~     Retinoblastoma treatment has become more and more focused in the last years. New treatments~     developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.~      Intra-arterial chemotherapy with Melphalan has shown success in some patients but with~     limited response when there is marked vitreal seeding. For these cases Intravitreal~     injections of Melphalan have been successful in Japan.~      In this study the same chemotherapy (melphalan) will be administered intravitreally~     (directly through the eye wall) and the response (short and long term) will be monitored.~   "
114387|NCT01558947|"~     The purpose of this study is to evaluate the safety and the effect of perioperative~     chemotherapy in the treatment of advanced gastric cancer.~   "
114388|NCT01558934|"~     The primary objective of this study is to assess QTc (an interval of the heart rythym)~     interaction effects between lofexidine and methadone. The secondary objectives of the study~     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring~     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)~     and adverse events (side effects) when co-administered with methadone; and to describe~     effects on opiate withdrawal when lofexidine is introduced following a 50% or 100% methadone~     dose reduction, as required to elicit a withdrawal response. The investigators hypothesize~     that while both agents are known to prolong the QTc interval, the combination of the drugs~     will not create an additive effect which creates a significant safety concern. The~     investigators further hypothesize that subjects will be able to tolerate the therapeutic~     dose of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered~     to elicit withdrawal.~   "
114420|NCT01555606|"~     The purpose of the study is to develop a database containing patient-reported information~     that may be used to understand and to increase awareness of the impact that~     moderate-to-severe plaque psoriasis can have on both daily life and life in general from a~     patient's perspective. The database will include self-reported patient narratives on the~     topic of the experience of having moderate-to-severe plaque psoriasis and will include~     information on treatments received, as well as de-identified clinical photographs taken over~     the course of the disease.~   "
114389|NCT01558921|"~     Currently the 3-year disease free survival of patients with locally advanced rectal cancer~     is about 50%. Current standard treatment for patients at high risk of failing locally and/or~     systemically includes pre-operative long course radiotherapy (5 weeks) in combination with~     chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy~     has been demonstrated to improve local control, but had no effect on the overall survival.~     Different studies in patients with rectal cancer studying the effect of adjuvant post~     operative chemotherapy did not result in an improved survival. This may be due the fact that~     rectal cancer surgery (TME) is associated with a high complication rate so substantial~     proportion of patients cannot receive chemotherapy postoperatively. An alternative approach~     is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor~     short-course radiotherapy (5 days) is given, as different studies showed local control of~     the tumor for a long time. During this waiting period the patient is in a good condition to~     receive an optimal dose of chemotherapy. The investigators hypothesize that with this~     proposed protocol both the local tumour and possible micrometastases are effectively treated~     and that this will result in an increased survival. The investigators will compare this with~     the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional~     adjuvant chemotherapy.~   "
114390|NCT01558908|"~     This is a 15 patient clinical trial assessing the safety and feasibility of using~     Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are~     not eligible for surgical or catheter-based interventions. Three doses of ERC will be~     examined. The hypothesis is that ERC administration will be well-tolerated and possibly~     induce a therapeutic benefit.~   "
114391|NCT01558895|"~     The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat~     treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of~     the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the~     treatment. Clinical symptoms were also observed simultaneously.~   "
114392|NCT01558882|"~     The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo~     implantation. They are at the origin of the local secretion of cytokines, growth factors,~     chemokines affecting vascular development and the local immunotrophisme for the conceptus.~     The main objective of this study is to evaluate the expression of endometrial uNK cells~     before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of~     various cytokines and growth factors will also be studied.~   "
114393|NCT01558869|"~     This is an open-label, single centre, single-arm phase II study which aims to assess the~     efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan~     (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma.~     Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and~     analyzed in this study. The patients' data will be collected and maintained in the Division~     of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong~     Kong.~   "
114394|NCT01558856|"~     The primary objective of this study is to compare the efficacy of unilateral and bilateral~     neuromodulation tests at 1 month.~   "
114395|NCT01558843|"~     This multicenter, observational, study will enroll severe neurologically injured patients~     both prospectively and retrospectively. The aims are to identify the percent of~     neurocritical care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies~     employed, determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium~     concentrations in patients prior to sodium altering therapy, and evaluate outcomes through~     evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).~   "
114396|NCT01558830|"~     Ranolazine is an effective and remarkably safe agent for the treatment of patients with~     chronic stable angina, but its inhibition of voltage gated potassium channels and~     electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to~     question its safety when combined with antiarrhythmic drugs. The investigators have proposed~     a study to determine the safety of ranolazine in patients with chronic stable angina who~     also take amiodarone. And are conducting a prospective single-center randomized~     single-blinded placebo controlled trial to run out of our large cardiology practice setting~     at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference~     in the ventricular arrhythmia burden. The primary outcome will be the measurement of~     ventricular arrhythmia episodes on serial holter monitor and other serially acquired~     recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data,~     and stress test data) over a three month trial period.~   "
114397|NCT01558817|"~     Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly~     in patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic~     cancer. Recent work found that in-hospital CPR is being performed more often before death~     with unchanging survival and that fewer CPR survivors are being discharged home, thus~     suggesting that CPR is increasingly performed without benefit and that the burden of this~     ineffective treatment is increasing. Unlike other medical procedures, CPR has become the~     default provided to all patients even those with tremendously poor outcomes. It is time to~     change the paradigm of CPR. Through comparing an innovative informed assent approach~     toward in-hospital CPR (informing patients that their underlying chronic illness makes~     outcomes of CPR so poor that CPR is not performed while allowing them to disagree) versus~     usual care in a group of chronically ill patients with reduced life expectancy, the~     investigators aspire to demonstrate that CPR delivery can be reduced. And in addition that~     DNR status increases, while preserving patient quality of life and decreasing the burden of~     this ineffective treatment to both patients and families. If effective, this informed assent~     intervention has the potential to revolutionize how the investigators discuss CPR with the~     investigators chronically ill patients.~   "
114398|NCT01558804|"~     The purpose of the research is to help understand why some children become carriers of strep~     and whether children who are carriers need to be treated with antibiotics.~   "
114421|NCT01558596|"~     The investigators have previously shown that elective vascular surgery is a high-risk~     operation with an anticipated risk of either death or heart attack of 15%. This study is~     testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior~     to the operation is safe, feasible and reduces the incidence of an adverse, perioperative~     cardiac complication.~   "
114399|NCT01558791|"~     This research study is designed to learn about Veterans' understanding of mild TBI~     (traumatic brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to~     one of the study-related clinics for TBI screening will be invited to participate. An~     educational handout on TBI will be given to half of the participants along with their TBI~     screening. The other half of the participants will have the usual TBI screening without the~     educational handout.~      Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire.~     The questionnaire will ask:~        -  About the individual: such as gender and branch of service~        -  About what happened during the TBI screening: such as whether the Veteran had a chance~          to ask the provider any questions~        -  About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are~          long lasting~      Veterans who receive the educational handout will be asked specific questions about the~     handout and its information.~   "
114400|NCT01558778|"~     This pilot clinical trial studies mechanical stimulation in preventing bone density loss in~     patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent,~     or reverse bone loss, increase muscle and cardiac performance, and improve overall health~   "
114401|NCT01558765|"~     The aim of the study is to investigate the effect of an integrated rehabilitation programme,~     consisting of physical exercise training and psycho-educational consultations, for patients~     after heart valve surgery.~      The hypothesis is that integrated rehabilitation can improve physical capacity measured by~     V02 peak, self-rated mental health and life quality by validated questionnaires such as~     SF-36, and other objective parameters such as cardiac-specific biomarkers and~     echocardiographic measurements.~   "
114402|NCT01558752|"~     The main goal prospectively evaluate bone mineral density adjacent to the femoral component~     and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem~     compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL~     femoral stem group to show significantly less bone loss on the femoral side as compared to~     the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD)~     (g/cm2) from baseline (10-14 days post-op) to the one year post-operative interval, as~     measured radiographically in zones 1 and 7.~      Patients will be randomized to one of the two treatment groups prior to surgery. Each~     patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month~     visits following surgery.~      Bilateral DEXA bone mineral density tests will be performed at 10-14 days following surgery~     (baseline assessment) and at 6, 12, and 24 months post-operatively.~      Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months~     post-operatively after an overnight fast.~      The Harris Hip Score will be completed at each post-operative visit except the immediate~     (10-14 days), when risk of dislocation precludes a determination of range of motion. At the~     3, 6, 12 and 24 month post-operative visits, the patient will complete the RAND-36 Item~     Health Survey, WOMAC and UCLA activity scale.~   "
114403|NCT01558739|"~     The primary objective of this study is to evaluate the efficacy of INC424 in patients with~     PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (> 50%~     reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (>50%~     reduction in total symptom score at 48 weeks).~   "
114404|NCT01558726|"~     The purpose of this study is to evaluate the effectiveness of a Case Management (CM)~     intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs~     (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and~     90 days, considering the following outcomes: treatment retention, abstinence and changes in~     severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study~     hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during~     the 3-month follow-up compared with usual care (controls); 2)Individuals who received the~     intervention with GC are going to present a higher rate of abstinence; 3)The summary scores~     of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months~     follow-up.~   "
114405|NCT01558713|"~     Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine~     with addition of fentanyl for c-section either combined or not with administration of 10 ml~     of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile,~     haemodynamics and side effects were assessed.~   "
114406|NCT01558700|"~     This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after~     treatment with either duloxetine or placebo is associated with changes in brain anatomy.~   "
114407|NCT01558687|"~     The main purpose of this clinical trial is to find out if cilengitide has an effect on brain~     tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and~     oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.~      In addition, this clinical trial will investigate if the addition of cilengitide in~     combination with standard treatment prolongs life in patients with non-resectable~     glioblastoma. Similarly, the duration of response of the cancer to this treatment and the~     side effects of the therapy will be analyzed. Furthermore, additional data on how the body~     deals with this substance will be collected (this is called pharmacokinetics or~     pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to~     learn more about the disease and the response to the experimental medication by measuring~     certain markers.~      This imaging trial will investigate the biological effects of cilengitide monotherapy on the~     tumor microvascular function and tumor viability in a homogenous non-pretreated subject~     population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to~     study the effect that cilengitide may have on certain markers of cancer in your tumor and/or~     blood and to learn if there are any disease-related markers that could help in predicting~     how subjects respond to the administration of cilengitide.~      The investigators anticipate that approximately 30 subjects will participate in this~     clinical trial. The clinical trial will be conducted in approximately 4 medical centers in~     the following countries: Germany, Poland, and Switzerland. The investigators anticipate the~     clinical trial will last until the end of 2013. Your participation in the trial may last up~     to 86 weeks.~   "
114444|NCT01558297|"~     This study will test the effectiveness of two distinct treatments for weight loss:~        1. Motivational Interviewing~        2. Nutritional Counseling. These treatments will be compared to Treatment as Usual.~          Participants will be recruited through local primary care offices.~   "
114408|NCT01558674|"~     Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to~     furosemide in participants with moderate-to-severe renal insufficiency (RI) without heart~     failure (HF). Primary hypothesis for Part I is that at least one well-tolerated dose of~     MK-7145 will produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of~     MK-7145 dosing than 80 mg furosemide (on the 1st day of furosemide dosing) in participants~     with moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this~     study, MK-7145 will be investigated in participants with heart failure (HF) and RI (Part~     II).~      Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration~     (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable~     maintenance regimen of furosemide or torsemide in participants with New York Heart~     Association (NYHA) Class II and III heart failure and moderate or severe renal~     insufficiency. The primary hypothesis for Part II is that at least one dose of MK-7145,~     titrated according to a fixed dose titration regimen, will be associated with a reduction in~     N-terminal pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at~     24 hours postdose on the last dosing day of each period) in participants with NYHA class~     II/III HF with moderate or severe RI.~   "
114409|NCT01558661|"~     The purpose of this study is to find out what effects, good and/or bad, a new treatment~     called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study~     is called a phase II study.~      Axitinib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if axitinib is a useful~     drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug~     that has not yet been approved by the Food and Drug Administration for use in adenoid cystic~     carcinoma.~   "
114410|NCT01558648|"~     The goal of this study is to evaluate how surgery for esophageal cancer affects the~     patient's quality of life over time. The investigators hope this study will provide~     important information that can be used to improve the quality of life of patients with~     esophageal cancer. This study will also look at how standard tests and information collected~     from the patients difficulty swallowing can predict the extent of their esophageal cancer~     before surgery.~   "
114411|NCT01558635|"~     Studies have shown that taking drugs to stay out of AF has limited success. This research is~     designed to study heart rhythm after surgical therapy, namely by measuring if there are~     benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex~     Surgical Ablation System. The system is approved and commercially available with CE mark.~     The purpose of this study is to support evidence that the Cardioblate System is safe and~     effective to treat AF.~   "
114412|NCT01558622|"~     The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol,~     tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic~     Nissen fundoplication.~   "
114413|NCT01555697|"~     Cognitive training is moderately effective at reducing symptoms and improving life function~     in schizophrenia patients. The present application develops a strategy for increasing the~     effectiveness of cognitive training through the use of pro-cognitive medications. Specific~     biomarkers will be studied that identify patients most sensitive to these pro-cognitive~     medications, to test the feasibility of using these biomarkers in a large clinical trial of~     medication-enhanced cognitive training in schizophrenia.~   "
114414|NCT01555684|"~     Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that~     often results in reduced muscle function which produces fatigue, weakness and a decline in~     daily mobility. Although the underlying cause of the disease is unknown a possible~     contributory mechanism is chronic cerebrospinal venous insufficiency (CCSVI). Post-mortem~     studies and magnetic resonance venography have shown a strong relationship between the~     cerebral venous system and MS cortical plaques. From this a role for CCSVI in MS has been~     suggested: venous malformations that result in venous hypertension, pressure on the blood~     brain barrier and subsequent inflammation due to leakage of haemosiderin into the~     parenchyma. This provokes an immune response which results in neurodegeneration. A procedure~     known as percutaneous venoplasty whereupon a balloon is inserted and inflated into the~     jugular vein has been developed to improve this drainage of the CNS, reduce venous~     hypertension and improve symptoms associated with MS. Although this procedure is widely~     practiced throughout the world it has yet to be fully accepted as it needs to be supported~     by evidence based clinical trials. As such NHS National Institute for Health and Clinical~     Excellence (NICE) recently issued a consultation document to determine more about the~     procedure's clinical safety and efficacy. A common concern raised is the ability to prevent~     any possible placebo effect and like any other clinical trial should offer a sham procedure~     to a matched control group. The difficulty with this option are the ethical issues~     associated with an invasive sham treatment and also the practical issues of masking a~     potentially painful treatment such as venoplasty. One option is to have blinded neurological~     assessment of patients who have either been treated with venoplasty or had no active~     treatment. Another option is to use dependent measures that are unaffected by motivational~     or psychological influences which avoids any placebo effect issue. One such dependent~     measure is motor unit firing behaviour whilst contracting at a submaximal target force.~     Typically clinicians have used this to manage motor disorder patients but have used~     cumbersome invasive technology that can only measure a few motor units with limited~     accuracy. However, De Luca et al recently developed a high density surface electromyographic~     (HDsEMG) system that can measure 30-40 motor units with 92-97% accuracy. From this it has~     been proposed as a highly effective tool for evaluating efficacy of therapeutic~     interventions for upper motoneuron disorders such as MS.~      Accordingly the investigators propose to use a repeated measures design on an experimental~     (receiving venoplasty) and control (not receiving venoplasty) MS groups (6 patients in each~     group) to determine the effect of the treatment on muscular function, mobility and fatigue.~     This would be combined with independent blinded neurological assessment of the two groups of~     patients.~      This design enables us to achieve two aims:~        1. Acute neuromuscular response to the treatment~        2. Chronic response to the treatment (6 weeks) to determine the effect on muscular~          function, mobility and fatigue.*~      Methods~        -  Four (first two to establish baseline variability of measures) repeat visits to the~          laboratory at University of Stirling to establish neuromuscular measures:~             1. HDsEMG pre and post tetanic induced fatigue~             2. Muscle fibre conduction velocity as previously described (Hunter et al., 2011)~             3. Ultrasound for CCSVI determination on visits 1 and 3~             4. DEXA scans for alterations in body composition on visits 2 and 4~        -  With the use of accelerometers monitor free living activity on days 0-7 and 9-42 (post~          venoplasty).~   "
114415|NCT01555671|"~     Labor pain is universal and occurs acutely. This is the most painful experience in a woman's~     life. Pain relief during labor is expected to have positive impact on the progress, outcome~     and cost of labor. However, it is controversial whether labor analgesia shortens the length~     of labor and influences progression to cesarean.Labor analgesia can be performed via spinal,~     epidural or systemic routes (intravenous or intramuscular). Opioid agonists (meperidine,~     fentanyl etc.) as well are the systemic agents frequently used for labor analgesia.Results~     of the studies concerning effect of meperidine on the length of labor are controversial.~      Many studies have expressed that meperidine has no effect or effect on the progress of~     labor.This study aims to evaluate the effect of meperidine on the length of active phase of~     labor in nulliparous or multiparous women, who will be randomized into case and control~     groups.~   "
114416|NCT01555658|"~     Background:~      Randomized trials show improved outcomes among acute coronary syndrome (ACS) patients~     treated with Bivalirudin1. Optimal antithrombotic treatment in patients undergoing~     percutaneous coronary intervention (PCI) is crucial to balance the risk of post-PCI bleeding~     versus ischemic complications2. Bivalirudin, a direct thrombin inhibitor has been~     extensively investigated as an intra-procedural antithrombotic therapy in patients with~     stable angina, Non ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment~     elevation myocardial infarction (STEMI). Bivalirudin, when used with or without glycoprotein~     IIb/IIIa inhibitors (GPI) during PCI has been found to be superior to Unfractionated heparin~     (UFH) with or without GPI in reducing 30-day bleeding complications without significant~     increase in the rate of ischemic events3-5.~      Moreover,after otherwise successful PCI,an increase in cardiac biomarkers has been shown to~     occur in 5% to 30% of patients6. Recent studies have focused their attention onthe reduction~     of infarct size and the incidence of periprocedural (type IVa) myocardial infarction~     (PMI)after elective PCI7-8. Therefore, we will perform a single-center, prospective and~     randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of~     biomarkers of MI after coronary stent implantation in patients already treated with aspirin~     and clopidogrel,with anatomically complex lesion.~      Objective:~      to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients~     with coronary artery disease (CAD), after stent implantation in coronary long lesions, to~     avoid periprocedural myocardial necrosis.~      Setting:~      Single-center, spontaneous, prospective, randomized 1:1 study of Bivalirudin infusion vs UFH~     in the setting of CAD, after PCI with stenting incoronary long lesions.~      Comparison: Bivalirudin vs UFH, in preventing elevation of biomarkers of MI after coronary~     stent implantation in patients already treated with aspirin and clopidogrel, with~     anatomically complex lesion.~      Population:Patients with diffuse CAD undergoing percutaneous treatment on a native coronary~     vessel with planned implantation stents in overlapping with a total stent length >33 mm for~     long coronary lesions in vessels with a reference vessel diameter 2.25-4.0 mm.~      Assessment Following the procedure, blood samples for CK, CK-MB and Troponin will be~     collected at 6,12 and 24 h post PCI. CK-MB values will be considered abnormal if they will~     elevate above the upper limit of normal (ULN). This is set at 6 mg/L by our local~     laboratory. If the first blood sample showed a CK-MB level ≥18 mg/L (≥3 times upper normal~     limit), a second blood sample would be drawn every 8 h later until a downward trend will be~     observed. For patients with two or more blood samples drawn, the peak CK-MB level will be~     used for analysis.~      End-points:~      The primary end-point of this study will be the incidence of periprocedural myonecrosis that~     was defined as a peak post-procedural CK-MB elevation > 1 time the upper limit of normal~     (ULN) alone or associated with chest pain or ST-segment or T-wave abnormalities, in patients~     undergoing non-urgent PCI.~      Secondary end-points will be the rate of MACCE (major adverse cerebro-cardiovascular events,~     ie the composite of death, myocardial infarction [defined according to the Academic Research~     Consortium statement], target vessel revascularization or stroke), the rate of major~     bleedings (Bleeding Academic Consortium [BARC] 3-5), minor bleedings (BARC 2), and the rate~     of NACE (net adverse clinical events, ie the composite of MACCE and major bleedings) at 30~     days, 6 and 12 month follow-up. Adverse events will be determined by telephone interview~     and/or medical record review. Clinical follow-up: telephone-based interviews and~     office-based direct visits will be performed at 1, 6 and 12 months, respectively, for~     end-point adjudication.~      Sample size and statistical analysis: Given an expected rate of abnormal post-procedural~     peak CK-MB > 1 x ULM of 48% (based on results of the INSTANT trial) for the control group~     and 29% for the experimental group (thus a 40% relative risk reduction), aiming for a 0.05~     alpha and 0.80 power, a total of 204 patients will need to be enrolled (102 patients per~     group).~   "
114417|NCT01555645|"~     The purpose of this study within Caring sciences is to identify women with breast cancer who~     have stress symptoms and to offer these women appropriate care to reduce stress and increase~     well-being. This will be achieved by~        1. Studying the prevalence of stress related symptoms in female patients with breast~          cancer~        2. Testing the use of two short screening instruments to identify women at risk for~          developing long-standing stress symptoms~        3. Studying the level and intensity of stress management interventions required to achieve~          increased well-being, using a stepped-care approach.~        4. Studying the effects of interventions based on cognitive behavior therapy, delivered~          individually or in a group format.~      The hypothesis is that half of the individuals assigned to a low intensity intervention will~     be significantly improved after treatment. For individuals who continue to have symptoms~     after low intensity treatment it is hypothesized that continued treatment in a group setting~     with high intensity interventions will be more cost-effective. In addition the assumption is~     that reduction of stress symptoms in women with breast cancer will lead to a reduction in~     socio-economic costs.~   "
114418|NCT01555632|"~     This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic~     syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy.~     Atorvastatin calcium may help prevent or reduce metabolic syndrome caused by long-term~     androgen-deprivation therapy~   "
114419|NCT01555619|"~     The purpose of this post approval study is to evaluate the acute and chronic performance of~     a Quadripolar CRT-D device system in a patient population indicated for cardiac~     resynchronization therapy.~   "
114445|NCT01558284|"~     Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS,~     20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and~     5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.~   "
114422|NCT01558583|"~     Participants will be recruited from the United States and Australia to take an online survey~     about colon cancer screening or prostate cancer screening. Individuals selected for both the~     prostate cancer survey and the colon cancer study will be randomized to take one of three~     survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will~     help participants clarify their values and opinions about screening options for colon cancer~     or prostate cancer. Participants' responses to the online survey are measured at one point~     in time - the time at which the participant takes the survey.~   "
114423|NCT01558570|"~     The purpose of this protocol is to collect serum zonulin levels in people with~     schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin~     (tissue transglutaminase and antigliadin antibodies) and other information that may relate~     to increased intracellular tight junction permeability as it related to the immune and~     stress system and the immune association with kynurenic acid pathway 50. Data will be~     collected for use in future grant applications and published reports.~   "
114424|NCT01558557|"~     Background: Celiac disease is an immune-mediated reaction to gluten, presenting with~     diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic~     and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates~     back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia~     participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)~     study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease~     (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age~     adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison~     sample). It is hypothesized that a gluten free diet in people with schizophrenia who have~     Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.~      Objectives: The aim of this proposed pilot study is to establish the feasibility of a~     initiating and maintaining a Gluten-free diet in these two groups. For this study The~     investigators will identify 8 individuals who have positive assays to tTG antibodies and~     confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The~     investigators plan to consent at least 2 subjects from each group and ask them to~     participate in a two-week open label treatment of a gluten free diet. The groups are;~        1. Celiac disease (positive tTG antibody); and~        2. Positive assay on Antigliadin antibodies~   "
114425|NCT01558544|"~     The study hopes to contribute to the development of technologies of ovarian tissue~     freezing-thawing and in vitro maturation of immature eggs such that a person at risk for~     premature ovarian failure might be able to conceive a genetically related child.~   "
114426|NCT01558531|"~     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty~     followed versus conventional balloon angioplasty in superficial femoral artery and popliteal~     artery re-stenosis.~   "
114427|NCT01558518|"~     Transthoracic echocardiography (TTE) represents an established and fundamental tool for the~     evaluation of patients with known or suspected cardiovascular disease. Recently,~     manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a~     physician's lab coat. Studies assessing these handheld devices have several limitations.~     While they have generally evaluated the handheld devices favorably, previous studies has not~     consistently studied handheld devices under the best possible clinical conditions and have~     not necessarily highlighted the devices' limitations.~      In this proposal, we seek to analyze the applicability of handheld echocardiograms to~     standard clinical practice. The investigators plan to use trained sonographers to perform~     handheld examinations on patients referred for TTE without established cardiovascular~     disease. The handheld images will be interpreted by experienced, consultant-level~     echocardiographers. The investigators then plan to compare findings from the handheld~     echocardiogram to the patient's standard clinical TTE.~   "
114428|NCT01558505|"~     Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral~     intervention (PTA). The aim of the study is to investigate in a randomized fashion the~     efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec,~     Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia,~     Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of~     below-the-knee (BTK) vessels.~   "
114429|NCT01558492|"~     The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel~     and correlate response to study treatment with biologic parameters (i.e. lab studies of~     blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into~     the underlying biology of prostate tumor progression and perhaps predict which patients may~     benefit from this chemotherapy regimen.~   "
114430|NCT01558479|"~     The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching~     for genes that increase the risk of developing Parkinson's disease (PD) and related~     disorders. The study is a joint effort by neurologists and researchers across the United~     States and is sponsored by the National Institutes of Health. The coordinating center for~     PaGeR is located at the University of Washington and the VA Puget Sound Health Care System~     in Seattle.~   "
114431|NCT01558466|"~     This study hopes to evaluate the effectiveness of early combined use of Sildenafil and~     nitric oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or~     hypoxemic respiratory failure and assess whether this would improve oxygenation, improve~     time on mechanical ventilation for these babies and also prevent rebound hypoxic episodes.~   "
114432|NCT01558453|"~     The purpose of this study is to determine the pediatric neoplastic response to chemotherapy~     proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1~     expression analysis.~   "
114446|NCT01558271|"~     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in~     participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.~   "
114625|NCT01556061|"~     The investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable~     alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese~     patients. The D-MAC will enable superior view of the glottic structures as well as easier~     endotracheal intubations than the C-MAC blade. This is the first study to investigate the~     individual and comparative performances of C-MAC and D-MAC in this patient cohort.~   "
115055|NCT01550159|"~     This study aims to evaluate the possible Correlation Between Serum Levels of Markers of~     Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.~   "
114433|NCT01558440|"~     Hypothesis:~      During rehabilitation phase of management of severe acute malnourished Bangladeshi infants~     less than 6 months old, rates of weight gain will be significantly more in children fed~     F-100 and diluted F-100 compared to those fed infant formula.~      Brief summary:~      Until recently, severe malnutrition has been relatively rare in infants younger than 6~     months, but with urbanization and the HIV/AIDS pandemic it is feared that the incidence of~     severe malnutrition among young infants will rise. The question of how best to feed infants~     aged <6 months has thus come to the forefront. Given the lack of published evidence~     regarding the most advantageous formulations for feeding severely malnourished infants aged~     <6 months, there is a need for observational studies and comparative randomized trials of~     alternative formulations to guide decisions about optimum dietary management in this age~     group. This area has been aptly considered a research priority during the consultation~     meeting of experts from all over the world convened by the World Health Organization on~     management of severe malnutrition in September 2004.~      In the WHO case-management guidelines for severe malnutrition, there is no separate~     provision for young infants (infants less than 6 months old). The guidelines suggest the use~     of a low-solute formula (F-75) and continued breastfeeding in the initial stabilisation~     phase. In the rehabilitation phase, the guidelines advise F-100 with an energy density of~     100kcal/100ml to promote catch-up growth. There is a concern that the renal solute load from~     using F-100 is too high for young infants, and some groups have started using diluted F-100~     with an energy density of 75 kcal/100 ml.~      Another related issue is the contribution of breastfeeding in dietary intakes during~     rehabilitation. In severely malnourished infants, breast milk intakes are likely to be low~     initially when appetite is poor, but may be substantial as the infant recovers. Uncertainty~     about breast milk intakes has led to conflicting opinions and advice, weaning from the~     breast as it is not providing sufficient energy (1).~      The aim of this study, to be conducted in a carefully supervised Nutrition Rehabilitation~     Unit (NRU), will compare three recovery diets (Infant formula, F-100 and diluted F-100) in~     order to provide the evidence-base to determine if a change or add-on in terms of diet in~     the WHO guidelines is needed. It will also measure the potential renal solute load~     (mosmol/l), serum electrolytes and plasma osmolality of the same children. Body composition~     of the infants will also be measured using stable isotope dilution technique before and~     after the intervention diet is provided.~   "
114434|NCT01558427|"~     Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are~     conventionally treated with androgen deprivation therapy. However, in patients with limited~     metastatic load, the time to progression might be. Subsequently, active surveillance of~     these patients until progression might defer the start of androgen deprivation therapy (ADT)~     for several months to years. As an alternative, salvage treatment of the limited number of~     metastases with either surgery or radiotherapy might postpone the start of ADT even longer.~     The current trial hypothesizes that ADT might be deferred longer following salvage treatment~     as compared to active surveillance.~   "
114435|NCT01558414|"~     Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study~     will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a~     transumbilical single site incision will be performed with two different manners:~     single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope~     and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The~     third group is the control one, a conventional laparoscopic approach.~      The trial is designed as a pilot study to assess, as main objective, if these two endoscopic~     approaches have the same security and effectiveness in cholecystectomy.~      Hypothesis:~      Transumbilical approaches with single port and single incision with the flexible endoscope~     have the same efficacy and safety performing the endoscopic cholecystectomy.~      Objectives:~      Main objective:~      Assess whether both approaches are equally safe in its application to endoscopic~     cholecystectomy.~      Secondary objectives:~      Investigate the differences in the rate of conversion to open surgery between different~     surgical approaches.~      Investigate the differences in the rate of wound infection between the different surgical~     approaches.~      Investigate the differences in the rate of postoperative incisional hernias between~     different surgical approaches.~      Investigate whether there are differences in the rate of overall complications, all-cause~     mortality and the cost between different surgical approaches.~   "
114436|NCT01558401|"~     The purpose of this study was to identify the effects and the efficiency of an adapted~     physical activity program as regards the physical condition of older Brazilian women.~   "
114437|NCT01558388|"~     Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of~     Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic~     bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased~     risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial~     vaginosis has been reported in 10-70% of cases. This study aims to verify if administration~     of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of~     bacterial vaginosis during pregnancy.~   "
114438|NCT01558375|"~     Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and~     the efficacy of anakinra over placebo for the management of patients with hidradenitis~     suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on~     subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the~     protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the~     comparisons of visual analogue scores, of disease activity, of Sartorius score and of~     dermatology life quality index between the two groups of treatment over follow-up.~   "
114439|NCT01558362|"~     The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient~     management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian~     Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute.~     Initial testing results in rats and pigs suggest that in addition to being a~     cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer~     for measuring myocardial perfusion.This Phase 1 study will study the safety and~     tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution~     and localization of I123-CMICE-013in healthy adult volunteers.~   "
114440|NCT01558349|"~     The main objective of this study is to compare results for the detection of circulating~     melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques~     between a group of patients with metastatic melanoma and a group of hospitalized control~     patients.~   "
114441|NCT01558336|"~     The purpose of this study is to evaluate the impact of praziquantel for the treatment of~     Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.~   "
114442|NCT01558323|"~     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of~     renal impairment to healthy subjects~   "
114443|NCT01558310|"~     This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous~     injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The~     purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the~     treatment of scalp psoriasis by determining the proportion of subjects who clear or almost~     clear in scalp specific physician assessments. The study will include approximately 30~     subjects.~   "
114447|NCT01558258|"~     Younger women with breast cancer experience substantially greater distress and depressive~     symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can~     reduce the risk of recurrence and/or other chronic diseases. The primary objective of this~     study is to evaluate the feasibility and preliminary efficacy of a mindfulness~     meditation-based intervention for this at-risk group of women. The investigators hypothesize~     that a structured program of mindfulness meditation will lead to significant improvements in~     psychological well-being (i.e., depression, stress), with corresponding improvements in~     health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior~     to age 50. The investigators will also examine mechanisms for intervention effects,~     including increased mindfulness and ability to relax.~   "
114448|NCT01558245|"~     The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the~     long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis~     of the middle cerebral artery (MCA) M1 segment~   "
114449|NCT01558232|"~     The objective of this clinical study is to examine acute changes in stability, force~     allocation, work, and mobility from using a wearable, portable, battery-operated robotic~     orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity~     physical therapy.~   "
114450|NCT01558219|"~     This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of~     metastatic castration resistant prostate cancer (mCRPC) patients previously treated with~     docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include~     time to treatment failure, response rate, overall survival and quality of life.~   "
114451|NCT01558206|"~     In this study the investigators compare the diagnostic validity of Bedside Ultrasonography~     of chest and Pulmonary artery CT Angiography in the patients who came to Emergency~     Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory~     symptoms and signs in favor of Pulmonary Thromboemboli (PTE).~   "
114452|NCT01558193|"~     There is a series of well designed studies that have reported, in those with a history of~     anti-social behavior, that supplementation with vitamins / minerals, omega-3 fatty acids~     (n-3 FA), or both, reduces the incidence of aggressive behavior. Although there is evidence~     that all these nutrients have a role, to date the relative contribution of fatty acids and~     vitamins / minerals has not been considered: for example the possibility of a synergistic~     interaction has not yet been examined. In addition the topic has to date been studied under~     real-life condition, such as a prison, making the topic difficult to study. The major aim of~     the present study was to develop a paradigm that would allow the study of the topic in a~     sample from the general population without a history of anti-social behavior. Subjects~     received either a vitamin/mineral supplement, a fatty acid supplement, both or neither for~     three months, Measures of impulsivity and aggression were assessed before and after~     supplementation. Although in the past measures of actual behaviour have proved to be~     sensitive to supplementation, questionnaire measures have not. The second major objective~     was therefore to consider whether such phenomena can be studied in a sample without a~     history of anti-social behavior, using standardized, sensitive laboratory based measures and~     to compare these with questionnaire measures.~   "
114453|NCT01558180|"~     The investigators will conduct a randomized controlled trial comparing a telephone based~     intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a~     series of phone calls to assist caregivers in learning and modifying behavioral strategies~     that may help young children with autism to sleep better. Objective (activity monitors) and~     subjective (rating scales) data will be collected by an independent research assistant at~     the end of the project. The investigators hypothesize that TCM improves sleep duration and~     decreases sleep problems relative to a usual care control condition (UC).~   "
114454|NCT01558167|"~     This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define~     safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a~     safe and efficacious dose for future phase II/III study.~      Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and~     efficient.~   "
114455|NCT01558154|"~     Comparison of different assessment methods to evaluate the treatment efficacy of Chinese~     medicine on minor and mild depression.~   "
114456|NCT01558141|"~     Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy,~     which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm~     insemination, embryo culture and embryo transfer.~      The oocytes are removed during surgery by aspirating the follicles using a single lumen~     needle with an ultrasound to guide the procedure. There is some data that flushing the~     follicles with embryo culture media before aspiration using a double lumen needle increases~     the number of oocytes retrieved, particularly among poor responding patients for whom each~     additional oocyte recovered may substantially alter the outcome of that IVF cycle.~      The objective of the research is to evaluate the effect of follicular flushing in poor~     responders on IVF cycle outcomes.~   "
114457|NCT01558128|"~     To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop~     postoperative atrial fibrillation~   "
114469|NCT01557972|"~     Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at~     home (HBP) in the morning offer stronger predictive power for micro- and macrovascular~     complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure~     measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study~     for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up~     HBP provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et~     al, 2010).~      However, it is not clear to show which of BP measurement provides the stronger predictive~     power for outcomes by comparing cumulative events over a longer time than 6 years.~     Therefore, the investigators examined which of HBP or CBP provides the stronger predictive~     power for outcomes in addition of renal anemia reported previously over 10 years in the~     patients with type 2 diabetes.~   "
114658|NCT01555372|"~     The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking~     Plate (LP) reduces the postoperative complications and leads to a better functional recovery~     after unstable distal clavicle fractures (Neer 2b).~   "
116119|NCT01536223|"~     Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive~     either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and~     5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.~   "
114458|NCT01558115|"~     Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone~     (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen~     most often in postmenopausal women. Many patients with PHPT have low bone mineral density~     (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the~     forearm. There is currently no effective medical therapy which increases bone density at the~     forearm in patients with PHPT.~      PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions~     are beginning to be identified. Prior research suggests that RANKL, a molecule important in~     bone metabolism, responds to PTH, and that if the RANKL is inactivated, PTH is shifted~     towards building bone. The investigators will study the effect of Denosumab, a therapeutic~     agent that binds to and inactivates RANKL, in 28 postmenopausal women with PHPT. Our~     hypothesis is that Denosumab will increase bone mineral density in primary~     hyperparathyroidism.~      The study will last two years, and subjects will be randomly assigned to receive either~     placebo or Denosumab for the first year of the study. In the second year, all subjects will~     receive Denosumab. Denosumab (60 mg) or placebo will be given every 6 months by an injection~     just under the skin. Study procedures performed will include bone mineral density tests by~     DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) scans, and~     assessments of biochemical markers of calcium metabolism and bone turnover using both blood~     and urine samples of subjects with PHPT.~   "
114459|NCT01558102|"~     The primary objective of this retrospective study is to determine the incidence of important~     safety outcomes in patients who have undergone Pipeline Embolization Device placement for~     intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed~     to observe and capture information from numerous hospitals.~      Data collection will be initiated starting March 2012 and continue until approximately April~     2017.~   "
114460|NCT01558089|"~     This open-label, prospective, observational study will evaluate the clinical response to~     etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis,~     as prescribed by the rheumatologist in a normal clinical setting in Greece~   "
114461|NCT01558076|"~     The purpose of this study is to use comprehensive exercise testing to examine longitudinal~     changes in exercise capacity over a 2 year period in children and young adults with sickle~     cell anemia.~   "
114462|NCT01558063|"~     Depressed patients will be offered experimental treatment with a new, potentially~     fast-acting antidepressant called ketamine while being scanned by magnetic resonance imaging~     (MRI) to measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0~     (placebo), 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg. If a patient does not respond to ketamine after~     the first infusion, it may be because s/he received ketamine placebo or the dose of ketamine~     was too low. In that case, an optional second scan and infusion of active ketamine (0.5~     mg/kg) will be offered. This second scan will occur no later than weeks after the first~     scan/infusion (as scheduling permits). There is no guarantee that the patient will respond~     to the second ketamine infusion. Patients enrolled in the study are eligible for up to 6~     months treatment with their study psychiatrist after the ketamine infusion(s).~      Healthy Volunteers: Healthy controls will receive an infusion of ketamine at a single dose~     (0.5 mg/kg). Volunteers will only receive one MRI scan and infusion.~   "
114463|NCT01558050|"~     In this study the investigators investigate the effect of a red rice product on plasma~     lipids in a sample of physicians and/or their family members.~      After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to~     receive a commercially available red rice product or placebo. After a period of 8 weeks,~     lipid levels are measured again.~   "
114464|NCT01558037|"~     Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having~     evidence of having the infection at sometime in their life. Patients who have undergone~     transplantation are at risk at developing CMV, especially those patients who do not have~     antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies~     to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware~     they have the infection without tests to detect the virus. CMV can less commonly cause~     serious infections that affect many parts of the body including the intestines, liver, or~     lungs. In rare cases CMV infection in transplant patients can cause death.~      All patients who receive a transplant are monitored for CMV infection. The purpose of this~     study is to determine if there is a way the investigators can determine in advance which~     patients are at greatest risk of CMV infection. Specifically, this study will analyze the~     immune system of transplant patients to determine if there are specific elements of the~     immune system that 1) helps protect the body against CMV infection, and 2) helps the body~     combat CMV once it is infected. Identifying these specific elements of the immune system~     could improve the physician's ability to monitor the SOT patients for CMV infection, and to~     help treat CMV in those patients that become infected.~   "
114465|NCT01558024|"~     The main objective of this study is to obtain data to determine, in each individual with and~     without wearing compression stockings of different strengths and during different postures,~     the relationship between interface pressure and the area and circumference of the great~     saphenous vein and posterior tibial veins in the calf and ankle.~   "
114466|NCT01558011|"~     This is an open-label, non-comparative phase II study of sequential capecitabine plus~     oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric~     adenocarcinoma.~   "
114467|NCT01557998|"~     Interventions for injecting drug users (IDUs) in sub-Saharan African have been almost~     entirely absent, despite the fact that in countries like Kenya they contribute a growing~     proportion of incident HIV infections. This study will leverage a historic decision in Kenya~     to launch needle exchange program (NSP) and related services for this most-at-risk~     population (MARP). The investigators will use this NSP/MARP platform to seek out IDUs,~     deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers,~     and evaluate community viral load impact using a stepped wedge cluster-randomized design.~     Lessons learned will have important applicability throughout sub-Saharan African.~   "
114468|NCT01557985|"~     This study is being done to try to learn more about how a child's body breaks down~     bupivacaine, a local anesthetic medication that is being used for pain control. This study~     will provide information about how much medication gets into the bloodstream and how long it~     remains in the blood. Newborns and young infants often process drugs in their body in a~     different way than older children. This study will help the investigators determine how~     bupivacaine is broken down in the body of infants.~   "
114470|NCT01557959|"~     This phase II trial is studying how well docetaxel given together with cisplatin and~     pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB~     or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim,~     may increase the number of immune cells found in bone marrow or peripheral blood and may~     help the immune system recover from the side effects of chemotherapy. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and~     erlotinib hydrochloride may kill more tumor cells~   "
114471|NCT01557946|"~     Primarily, this study seeks to evaluate whether citalopram treatment is associated with an~     increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC)~     from baseline to day 3 of treatment. Additionally, this study would like to examine whether~     citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from~     baseline to day 7 of treatment.~   "
114472|NCT01557933|"~     The primary purpose of this study is to use magnetic resonance spectroscopy (MRS) to measure~     the levels of several brain chemicals including, but not limited to, glutamate, glutamine,~     and N-acetylaspartate, before and after treatment with ECT. In addition to MRS, the~     investigators will use several other MRI techniques including structural MRI, resting state~     functional MRI (fMRI), and diffusion tensor imaging (DTI) to measure how the structure and~     function of the brain changes with ECT.~      The investigators hypothesize that the Gln/Glu ratio is increased in the anterior cingulate~     cortex (ACC), but not the parieto-occipital cortex (POC), following the first ECT treatment.~   "
114473|NCT01557920|"~     The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper~     airway to collapse more easily and causes less activity in the tongue muscle. Additionally,~     the investigators hypothesize that, under increased carbon dioxide concentrations of the air~     inhaled, the upper airway will be less likely to collapse under anesthesia and there will be~     increased activity in the tongue muscle under both propofol and sevoflurane, when compared~     to breathing normal concentrations of carbon dioxide, as in room air. Furthermore the~     investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an~     effect additionally altered by increased carbon dioxide through increased respiratory drive.~   "
114474|NCT01557907|"~     The primary objective of this study is to investigate if intradermal (in the skin) basal and~     bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately~     control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period~     of up to three days and if intradermal delivery of insulin has advantages over standard~     subcutaneous (under the skin) delivery.~   "
114475|NCT01557894|"~     The main aim of this study is to investigate the effectiveness of an Internet-delivered~     intervention for social phobia by comparing it to a waitlist control group. The second aim~     of the study is to track the potential changes in participants' thinking patterns. Because~     this is among the first guided Internet-delivered interventions conducted in Romania, the~     treatment credibility will also be investigated. Finally, the predictive power of anxiety~     sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.~   "
114476|NCT01557881|"~     This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging~     (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as~     PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to~     treatment~   "
114477|NCT01557868|"~     The purpose of this study is to evaluate whether the investigators can develop a computer~     algorithm to predict which individual patients will respond to injections of hyaluronic acid~     (HA) products for knee osteoarthritis.~   "
114478|NCT01557855|"~     The objective of this study is to collect data on the commercial use of CORUS® (validated~     quantitative in vitro diagnostic test) Coronary Artery Disease (CAD) blood test to evaluate~     the clinical referral patterns of Primary Care Physicians after receipt of their patients'~     CORUS Score, and to better understand patient management patterns for clinicians ordering~     the test.~   "
114479|NCT01557842|"~     The purpose of this study is to determine if early ablation (i.e., ablation of ventricular~     tachycardia in patients with infrequent VT episodes) is more effective than medical therapy~     alone for the treatment of ischemic ventricular tachycardia in patients with Implantable~     Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia~     despite drug therapy.~   "
114480|NCT01557829|"~     This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into~     two groups: one to receive a new ceramic implant and a control group with a more traditional~     PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will~     measure and compare pain and disability improvement with the two implanted devices over a~     period of two years. The fusion status will also be judged with plane x-rays and one CT~     scan.~   "
114481|NCT01557816|"~     This study aims to evaluate various methods of measuring pain relief in subjects who have~     chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be~     treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day~     followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment,~     subjects will have another week of wash-out followed by a second period of 1 week of the~     alternate treatment. Subjects will not be allowed to use oral non-steroidal~     anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their~     target knees during the study. Acetaminophen will be allowed as a rescue medication.~   "
114530|NCT01557257|"~     To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the~     administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice~     Daily in Healthy Volunteers~   "
114531|NCT01557244|"~     The objective of the study is to find out if the medicine fesoterodine is a useful treatment~     in children with bladder muscle overactivity caused by a neurological condition. Children~     will be aged 6 to 17 years old. This is done by finding out how well it works, what the body~     does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It~     will be compared with the medicine oxybutynin, which is already available for treating the~     condition.~   "
116120|NCT01536210|"~     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children~     with ADHD.~   "
114482|NCT01557803|"~     The objective of this project is to determine clinical and biological predictors of Immune~     Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are~     started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of~     this syndrome. The investigators will prospectively study HIV infected patients in Sub~     Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its~     different appearances. In these patients, the investigators will assess the value of~     clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain~     insight into which inflammatory pathways become activated during IRIS. This project will~     provide novel knowledge about this clinically highly relevant healthcare problem in a~     resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt.~     In Gabon little research has been done in the field of HIV. The epidemiological pattern of~     IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for~     their use in daily practice.~   "
114483|NCT01557790|"~     Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with~     Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the~     Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of~     Defense. In the feasibility portion of the study patients will be evaluated to determine~     acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that~     proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).~   "
114484|NCT01557777|"~     Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia~     (CLL).~   "
114485|NCT01557764|"~     This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together~     with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2~     gene mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for~     cell division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor~     cells to grow and spread. Giving lapatinib together with trastuzumab may provide a more~     effective treatment for patients with this type of cancer.~   "
114486|NCT01557751|"~     In preparation for future large-scale genome wide association studies, reliable methods must~     be developed for measuring perceived pain and for estimating the effects of potentially~     confounding factors such as appropriate covariates. The major objectives of our pilot~     investigation are to develop optimal methods to characterize the primary endpoint of the~     study—knee pain, and to gather preliminary data on genetic markers in the human genome that~     are associated with a certain pain phenotype. The specific issues for this study will be to~     carry out a preliminary gene association analysis of acute perioperative pain in individuals~     undergoing total knee replacement and to define a pain phenotype that is composed of~     multidimensional domains such as opioid consumption, inflammatory markers, anxiety level,~     degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up~     changes in pain experience that can be attributed to single nucleotide polymorphisms.~   "
114487|NCT01557738|"~     It has well known that diets rich in fruits, vegetables and cocoa products are associated~     with positive health benefits and these positive effects have been shown to be due to~     compounds they contain called flavanols. Flavanols have been shown to exert their positive~     effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent~     vasodilator that is believed to play a role in increasing blood flow to active muscle during~     exercise. This regulatory process is impaired with healthy aging. The underlying premise to~     this study is that if NO bioavailability can be increased following flavanol ingestion, will~     there be a restoration of blood flow during exercise in older individuals? Accordingly, the~     first part of this research project will compare the acute vascular effects of flavanol~     ingestion between a young and old group. The investigators have hypothesized that both~     groups will show an improvement in blood flow to active muscle during exercise, though the~     magnitude of the change will be greater in the older group. The second part of this project~     will look at the effects of 4 weeks of daily flavanol ingestion in the old group. The~     investigators hypothesize that subjects will demonstrate an improvement in blood flow to~     active muscle during exercise after the 4 week intervention and that the magnitude of the~     change will be greater than the acute effects. Findings from this proposal will provide~     evidence for the efficacy of flavanols to be used (as a simple and safe lifestyle~     intervention) to reverse or combat impaired blood flow regulation in older individuals.~   "
114488|NCT01557725|"~     There are many different views regarding ideal duration and type of thromboprophylaxis after~     hip or knee surgery.~      An important factor in Fast-track surgery is early mobilization, which in itself is thought~     to prevent clotting.~      The investigators hypothesize that there is no increase with regards to thrombosis in~     patients receiving fast-track surgery with early mobilization and chemical thrombosis~     prophylaxis only during hospitalization.~   "
114489|NCT01557712|"~     The objective of this study is to evaluate the effectiveness of ketamine (infusion of~     0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major~     depression (MADRS score ≥ 20 ) to six weeks of treatment.~   "
114490|NCT01557699|"~     This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be~     given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV~     by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will~     be followed for 180 days for safety.~   "
114491|NCT01557686|"~     The purpose of this pilot study is to test an exercise-based multidimensional intervention~     for patients with acute leukaemia undergoing consolidation chemotherapy in the context of~     outpatient management. Further, to test for safety, feasibility and preliminary effect on~     physical and functional capacity, and health related quality of life.~   "
114557|NCT01556906|"~     The primary objective of this study is to evaluate the safety and tolerability of 4 doses of~     lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an~     additional 3 dose levels over a 16-week period.~      The secondary objectives of this study included the evaluation of the pharmacodynamics of~     lomitapide based on:~        -  Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC),~          triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at~          the end of each 4-week dosing period compared to the Baseline value of each parameter~          at the end of the previous dose phase(s).~        -  Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo~          CIII, apo E) and lipoprotein a [Lp(a)].~   "
114492|NCT01557673|"~     Following surgery some patients are unable to swallow. For those requiring nutritional~     support a tube is sometimes passed through the nose into the stomach to provide feeding.~     Traditionally this type of feeding is given slowly over the course of the day. However, it~     is thought that this mode of feeding might increase the amount of fluid entering the bowel~     contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger~     volumes in a shorter space of time resembles normal feeding patterns and may reduce the~     amount of water entering the bowel.~      In this study we want to use a non invasive medical imaging technique called magnetic~     resonance imaging (or MRI) to look at the volume of bowel water following these two feeding~     strategies in 12 healthy volunteers.~      Each volunteer will have a tube inserted into the stomach via the nose and undergo the two~     feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner~     to assess the bowel response and some samples of blood are required for analysis of blood~     sugar.~   "
114493|NCT01555593|"~     -  Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by~          inflammation of peripheral airways walls.~        -  Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8),~          Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor~          alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde~          (NO) are implicated in the inflammation.~        -  Exhaled NO concentration is usually used to monitor bronchial inflammation~        -  The relationship between decubitus and small airways behaviour is not well understood.~        -  Our hypothesis is that cyclic opening and closure of peripheral airways during~          decubitus can provoke an inflammatory response which can be monitored by exhaled NO.~        -  Data about these physiopathological aspects is missing in literature.~   "
114494|NCT01555580|"~     The purpose of this study is to determine whether the drug Leukine (GM-CFS) is safe and~     tolerated by patients with autoimmune myasthenia gravis (MG).~   "
114495|NCT01555567|"~     Quadriceps muscle weakness is a common consequence of ACL injury. This muscle weakness is~     considered to result from neural inhibition preventing full muscle contraction and is~     referred to as arthrogenic muscle inhibition (AMI). AMI hinders rehabilitation by preventing~     gains in strength, increasing the risk of re-injury, and potentially placing patients at~     risk for chronic degenerative joint conditions. Quadriceps weakness that occurs following~     ACL injury is also thought to be caused by muscle atrophy which is thought to manifest due~     to alterations in muscle architecture, selective fiber atrophy or even neural deficits such~     as AMI. Importantly, interventions that are designed to counter this muscle weakness are~     required in order to promote long-term knee joint health. Hence, the purpose of the current~     study is to determine the efficacy of interventions that target quadriceps weakness to~     improve quadriceps muscle function and biomechanics in patients prior to and following ACL~     reconstruction. Specifically, the efficacy of neuromuscular electrical stimulation aimed at~     improving quadriceps neural activity and eccentric exercise intended to minimize quadriceps~     muscle atrophy will be investigated. The investigators expect that patients who receive the~     electrical stimulation therapy will demonstrate improvements in quadriceps strength and~     activation. Furthermore, it is expected that patients who receive both the electrical~     stimulation and eccentric intervention will demonstrate markedly greater gains in quadriceps~     strength and activation than patients who receive only the electrical stimulation therapy or~     standard of care post-surgery. The investigators also hypothesize that the patients who~     receive the electrical stimulation therapy and/or eccentrics will display knee motion~     similar to uninjured control subjects.~   "
114496|NCT01555554|"~     Understanding what treatments may facilitate perioperative care of Veterans with~     posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.~      Patients with PTSD are characterized by elevated central nervous system catecholamine~     concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At~     present, there are no data on the effects of perioperative beta blocker therapy in patients~     with PTSD, despite the rising significance of PTSD in Veteran populations.~      This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled~     for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to~     either a 14-day course of propranolol or placebo. This study will then follow these Veterans~     for a one-year period to evaluate the effects of the intervention on Veterans' surgical~     outcomes.~      The investigators hypothesize that patients with PTSD randomized to the propranolol group~     will demonstrate a reduced incidence of perioperative and postoperative morbidity and~     mortality.~   "
114497|NCT01555541|"~     The goal of this clinical trial is to show that incorporating ofatumumab instead of~     rituximab in combination with etoposide and cytarabine (OVA) is successful in collecting~     autologous stem cells for use in an autologous stem cell transplantation (autoSCT) and to~     examine its effectiveness in eliminating residual diffuse large B-Cell Lymphoma (DLBCL) in~     patients.~   "
114498|NCT01555528|"~     This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
114499|NCT01555515|"~     In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will~     get it by a small implant of skin using their own skin, the implant will be treated in the~     laboratory and programmed to secrete Epo. The implant secretes the patients own epo~     minimizing the need for injections for a period of up to 6 months.~   "
114500|NCT01557660|"~     Open-label extension of RIN-PH-302.~   "
114501|NCT01557647|"~     To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and~     time to clinical worsening.~   "
114558|NCT01556893|"~     This will be a prospective, single-center clinical trial of up to 50 eyes of subjects~     scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be~     screened for eligibility.~      Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior~     to excimer laser treatment.~      Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the~     stromal bed quality, and the amount of opaque bubble layer. All patients will be followed~     with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity,~     manifest refraction, slit lamp examination, and endothelial cell counts.~   "
114559|NCT01556880|"~     The purpose of this study is to prevent the professional drivers from pre-diabetes to~     diabetes.~   "
114502|NCT01557634|"~     The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid~     increase in preschool children. Intensive control of blood glucose levels, although~     essential to protect against onset and progression of diabetes-related complications, faces~     unique challenges in toddlers and preschool children. A closed-loop system can enhance~     accuracy of insulin delivery and help people with T1D attain a tight glucose control~     avoiding the risk of hypoglycaemia. The main components of the system are a continuous~     glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm',~     which calculates the amount of insulin to be given by the insulin pump according to the CGM~     values. In the studies performed thus far the efficacy and safety of closed-loop glucose~     control were evaluated in children and adolescents aged 6 to 18 years. The results showed~     that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as~     compared to the conventional insulin pump therapy. The objective of the current study is to~     extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may~     gain a great benefit from this novel therapy. The present study adopts an open-label,~     randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted~     insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12~     young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight~     studies in a clinical research facility, during which glucose levels will be controlled by~     either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with~     standard insulin. On both occasions, participants will receive a self-selected evening meal~     and closed-loop will run from 17:00 until 08:00am the following day. The study will take~     place at the Wellcome Trust Clinical Research Facility, Cambridge with participants~     recruited from paediatric diabetes clinics in England.~   "
114503|NCT01557621|"~     The purpose of this study is to determine if a collaborative centralized population-based~     reminder/recall intervention is more effective than a traditional practice-based~     reminder/recall intervention at increasing immunizations among young children.~   "
114504|NCT01557608|"~     Numbness, tingling, and pain in the hands and feet following the administration of~     chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in~     oncology patients. However, more information is needed on why patients develop neuropathy~     and how it impacts their mood, ability to function, and their quality of life. In addition,~     effective treatments for this problem are not available at the present time. This study will~     be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did~     not develop CIN will be evaluated to determine why some patients do and other patients do~     not develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of~     life will be evaluated by comparing patients' reports on these important outcome measures.~     In addition, genetic markers that contribute to or protect against the development of CIN~     will be evaluated. Part 2 of this study will test the effects of a new treatment called~     photon stimulation (also called infrared light therapy) compared to placebo treatment to~     improve sensations in the feet of oncology patients with CIN. Patients who receive the~     photon stimulation will have greater improvement in sensation in their feet compared with~     those who do not receive photon stimulation.~   "
114505|NCT01557595|"~     Patients with ADHD often report staying up late on the computer, watching TV, or using other~     electronic devices, all strong emitters of blue light which may be contributing to the~     delayed sleep onset times seen in some of these patients. Evening use of polarizing glasses~     which filter out blue light may decrease the contribution of environmental light late at~     night to delayed bedtime. This is a treatment that Dr. Fargason uses when patients do not~     want to use sleep medication to help them fall asleep. The purpose of this study is to~     evaluate the effectiveness of this treatment by use of sleep diaries and sleep~     questionnaires.~   "
114506|NCT01557582|"~     The primary endpoint of this study is the percent difference between the VentriPoint Medical~     System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular~     volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial~     will be defined as positive if the mean VMS-cMRI percent difference is <10% and >-10% at a~     1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety~     concerns for the VMS procedure.~   "
114507|NCT01557569|"~     The purpose of this study is to examine the ability of atomoxetine compared to placebo to~     increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that~     atomoxetine will increase time before (if) the participant relapses.~   "
114508|NCT01557556|"~     Background:~      - Stressful situations often cause tobacco cravings. These cravings can make it very~     difficult for smokers who are trying to quit. Research has shown that craving may involve~     hormone pathways in the brain. The anti-anxiety drug pexacerfont acts on these hormone~     pathways. Researchers want to see if pexacerfont can act on the brain and lessen~     stress-related tobacco cravings in smokers who are trying to quit.~      Objectives:~      - To test the effects of pexacerfont on tobacco craving in smokers who want to quit smoking.~      Eligibility:~      - Smokers between 18 to 55 years of age who are trying to quit. (Participants must have~     smoked at least 10 cigarettes per day for at least 1 year.)~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be assigned to take either pexacerfont or a placebo. They will take~          three pills every morning for the first 7 days, then one pill every morning for 23~          days.~        -  At the first visit, participants will provide blood and urine samples. They will then~          be asked to prepare a 5-minute speech and give it to the study researchers. They will~          also be asked to do mental math problems for another 5 minutes. During these tests,~          blood pressure, heart rate, sweating, and skin temperature will be measured.~          Participants will fill out questionnaires about stress levels, tobacco cravings, and~          personal experiences.~        -  Participants will take the study pills for 30 days. Before the 2-week point,~          participants will be asked to try to quit smoking for 2 weeks.~        -  Participants will have four study visits. These visits will involve brain imaging scans~          and emotional stress tests. Tobacco cravings and other stress levels will be measured~          at each study. Blood and urine samples may be collected at these studies.~        -  Participants will have follow-up visits and phone calls for up to 6 months after the~          end of the study visits.~   "
114509|NCT01557543|"~     Background:~      - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated~     and are found to make large amounts of growth factors. Because they make growth factors,~     these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged~     heart muscle suggest that injecting these cells directly into damaged heart muscle can~     improve heart function. Researchers want to give stem cells to people who are having open~     heart surgery to see if they can help to repair heart muscle damage.~      Objectives:~      - To test the safety and effectiveness of bone marrow stromal stem cell injections given~     during heart surgery to treat heart muscle damage.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have open heart surgery for~     heart artery or vein blockages.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  Participants will have bone marrow taken from both hip bones about 3 weeks before the~          heart surgery.~        -  During the surgery, the stromal stem cells collected from the bone marrow will be given~          into the damaged portion of the heart muscle. The rest of the heart surgery will be~          performed according to standard procedures.~        -  After the surgery, participants will be monitored for complications from the stromal~          stem cells.~        -  Participants will have heart function tests to see if the stromal stem cell treatments~          were effective.~   "
114510|NCT01557517|"~     Background:~      - Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow~     transplants. It is the result of the donor cells trying to attack the recipient s body.~     Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors,~     and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can~     cause side effects when given as pills or injections. Steroids given in a cream or rinse~     form, applied directly to the site of the symptoms, can have fewer side effects. However,~     their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if~     a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.~      Objectives:~      - To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host~     disease.~      Eligibility:~      - Individuals at least 12 years of age who have oral GHVD and are not allergic to~     clobetasol.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and~          other tests before starting the study drug.~        -  Participants will be separated into two groups. One group will receive clobetasol; the~          other will have a placebo liquid.~        -  Participants will rinse their mouths with the study liquid three times a day after~          meals for 2 weeks.~        -  After 2 weeks, participants will have another study visit with blood tests and other~          exams.~        -  After the study visit, all participants will start to use the clobetasol rinse. Those~          who originally had clobetasol will use the rinse for another 2 weeks. Those who~          originally had a placebo will use the rinse for 4 weeks.~        -  Participants will have a follow-up exam after the end of treatment....~   "
114511|NCT01557504|"~     The purpose of this study is to assess:~        1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in~          pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years~        2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two~          sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets~          (excluding marking)~        3. the pharmacokinetics of sitagliptin and metformin following the administration of two~          sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM,~          aged 10 to 17 years.~   "
114512|NCT01557491|"~     Loss of hair growth potential in long surgical scalp incisions can become obvious to the~     patient and others, given hair's tendency to part along the resulting scar. Bevelling~     incisions perpendicular to the hair follicle angle may increase hair growth through the~     scar. However, many factors may be confounders such as wound tension and cauterizing the~     incision. This study will investigate the effect a bevelled incision has on hair growth~     preservation compared to a standard incision that incises the skin perpendicular to its~     surface irrespective of hair follicle angles. Following informed voluntary consent, subjects~     who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The~     right side of this bilateral incision will be randomized to receive either a bevelled or a~     standard incision and the left side will receive the opposite type. During routine surgical~     follow-up the hair growth within the scar of the two sides will be recorded for comparison~     and it is our hypothesis that the side with the bevelled incision will have more hair within~     the scar.~   "
114513|NCT01557478|"~     The study evaluate the effect of melatonin in improving quality of life and reducing post~     operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a~     multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or~     III breast cancer patients. Mixed-block randomization, stratified by center and treatment~     scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched~     placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on~     the first night prior to surgery and continue for 24 months. Standard treatment is surgery~     followed by chemotherapy according to each center's standard protocol. Study endpoints are~     QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence~     rate and progression-free survival.~   "
114514|NCT01557465|"~     The purpose of this study is to determine whether mechanical alternans (alternating strong~     and weak heart beats with a constant beat-to-beat interval), can be used to predict~     malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies,~     and to predict progression of heart failure and death.~   "
114515|NCT01557452|"~     Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular~     JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as~     IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.~   "
114516|NCT01557439|"~     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this~     study is to assess the bioequivalence between Test Product and the corresponding Reference~     Product under fasting condition in normal, healthy, adult, human subjects.~   "
114517|NCT01557426|"~     Objectives:~      This study aims to characterize severe skin and soft tissue infections (SSTIs) in the~     emergency department through the acquisition of ultrasound images. A wide range of SSTIs~     will be imaged and recorded, leading to a registry of these infections. The registry will~     show whether ED (emergency department) sonographers can accurately characterize these~     infections, as compared to the final hospital diagnosis. The registry will also provide data~     for a case-control study comparing ultrasonographic characteristics of necrotizing skin and~     soft tissue infections (NSTIs) to those of non-necrotizing SSTIs.~      Research procedures:~      In this study, the investigators will approach patients who present to the Emergency~     Department with a possible skin and/or tissue infection. Study subjects must be ED patients~     requiring admission to the hospital for the primary problem of an SSTI due to the need for~     follow-up. If the patient consents to participating in the study, the investigator will~     obtain and record an ultrasound image of the infected area. An ultrasound image of an~     uninfected area of skin will also be recorded for comparison. Patient information regarding~     personal history, physical examination, blood tests and x-rays will also be gathered from~     participants.~   "
114518|NCT01557413|"~     Primary purpose of this study was to compare functional outcomes after displaced and~     proximal humerus fracture between nails and locked plates.~      The hypothesis is that intramedullary nails provides satisfactory fixation and functional~     outcome compared to locked plate.~   "
114573|NCT01555450|"~     Variations in participation to the colorectal cancer screening seems to reveal social and~     geographical inequalities. Our study will investigate whether patient navigation could~     increase the participation to the colorectal cancer screening and in the same time, reduce~     the social inequalities.~   "
114574|NCT01556737|"~     Alleged benefits experienced after the consumption of soy in Asian countries have been~     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones~     are believed to relieve menopausal symptoms and are therefore often consumed in supplement~     form in Western countries. These supplements contain relatively high amounts of isoflavones~     and are on the market in different compositions. The question is whether supplements with~     different compositions exert similar effects or whether the effects differ substantially.~   "
114519|NCT01557400|"~     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is~     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining~     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads~     to weakness and loss of walking ability during childhood and teenage years. A specific type~     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in~     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense~     mutation. This study is an open-label trial for patients with nonsense mutation~     dystrophinopathy who received ataluren in a prior PTC-sponsored study at a clinical trial~     site in Europe, Israel, Australia, or Canada. The primary objective of the study is to~     evaluate the long-term safety of ataluren, as determined by adverse events and laboratory~     abnormalities.~   "
114520|NCT01557387|"~     Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds~     expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could~     decrease the need and expense of endoscopic biopsy for these lesions.~      Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging~     techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying~     techniques using indigo carmine which will predict diagnosis without biopsy.~      100 patients with inflammatory bowel disease will be enrolled in the study. Following a~     standard bowel preparation, each patient will be evaluated using standard endoscopic~     equipment. All patients will receive a standard bowel preparation (sodium phosphate,~     PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be~     performed for indications unrelated to the present study, including evaluation of response~     to medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal~     bleeding. Polypoid lesions will be examined using four consecutive methods: (a) high~     definition white light, (b) narrow band imaging, (c) chromoendoscopy (high definition white~     light with indigo carmine dye-spraying), and (d) histologic examination following biopsy.~     The flat mucosa surrounding the polypoid lesions will also be examined using theses four~     techniques in an effort to identify dysplastic tissue associated with these polypoid~     growths.~      High definition white light is the standard imaging modality used for colonoscopy. Narrow~     band imaging (blue wavelength of light) is also used routinely and is available on all~     current generation colonoscopes with the press of a button. Our division routinely uses~     chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel~     disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa.~     The dye used will be indigo carmine.~      Directed biopsy specimens will then be performed using a multibite forceps for targeted~     biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will~     be reviewed by the gastrointestinal pathologists at the University of Miami. The~     gastroenterologist's interpretation based on each of the three successive endoscopic methods~     will then be compared to the histologic evaluation with each individual lesion serving as~     its own control.~   "
114521|NCT01557374|"~     Ever since the biotherapy agents have entered the market, the recommended therapeutic~     objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try~     to reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to~     their tolerance in the medium and long term as well as their high price. Nevertheless, we do~     not dispose considerable data on the risks of relapse or structural progression during such~     a step down strategy. A few studies on anti-TNF agents have shown the possibility of such~     therapy reduction. A national study,  STRASS , coordinated by Bruno FAUTREL, has evaluated~     the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data~     concerning Abatacept or Tocilizumab has been published.~      As the expected result, this study is aimed to test the feasibility of a step down strategy~     on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.~   "
114522|NCT01557361|"~     The objectives of this trial are to determine whether, in critically ill patients with~     severe acute kidney injury (AKI), randomization to accelerated initiation of renal~     replacement therapy (RRT), compared with standard initiation, is:~        1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates,~          and achievement of follow-up; and~        2. Safe, from the perspective of potential adverse events associated with earlier~          initiation of RRT~   "
114523|NCT01557348|"~     This multicenter, prospective, observational study will assess the efficacy of~     MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid~     arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will~     be collected from each patient from the time of change in biologic therapy for 12 months.~   "
114524|NCT01557335|"~     This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel~     dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel~     dosed concomitantly.~   "
114525|NCT01557322|"~     1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world~          setting across two moderate RA cohorts: a Test Group of patients newly exposed to~          etanercept (Enbrel) therapy and a Control Group of patients with similar disease~          characteristics newly exposed to other, non-biologic therapies.~        2. To assess the change over time (from baseline to the most recent follow-up) in the~          characteristics described at baseline in 2 British Society for Rheumatology Biologics~          Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying~          anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).~   "
114526|NCT01557309|"~     The optimal timing for surgical repair of traumatic rotator cuff tears is controversial.~     Today there are no prospective studies investigating the short to mid-term outcome after~     early arthroscopic repair of traumatic rotator cuff tears and the Swedish National~     Musculoskeletal Competence Centre requests more research to this subject. The investigators~     will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair~     during the first year after surgery.~      The investigators hypothesise that the outcome after rotator cuff repair is good.~   "
114527|NCT01557296|"~     The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2~     and gastroparesis:~        -  validate radiopaque markers with fluoroscopy with gastric scintigraphy method~        -  study the difference of metabolic control including the frequents of hypoglycaemia,~          gastrointestinal symptoms, quality of life and nutrition state during dietary treatment~          of food of small particle size compared with food of large particle size~        -  validate the radiopaque markers method and measurement of the blood glucose and~          gastrointestinal symptoms after a test meal, against the gastric scintigraphy~        -  determine if the function of gastric emptying can be improved after intervention~   "
114528|NCT01557283|"~     With the new reimbursement criteria, we want:~      To describe the average treatment duration of patients with Enbrel expressed as a number of~     weeks/year.~      To describe the number of patients who receive continuous treatment To describe the number~     of patients who receive intermittent treatment To describe the number of weeks off treatment~   "
114529|NCT01557270|"~     The purpose of this study is to test the efficacy and safety of dexmedetomidine added to~     ropivacaine in patients undergoing shoulder surgery.~   "
114532|NCT01557231|"~     Chronic pain, by definition, persists over long periods of time, but both sufferers of pain~     and their caregivers are aware that pain levels can fluctuate greatly over time. Being able~     to define pain variability and its underlying causes would be an important advance in our~     understanding of chronic pain, and would in turn lead to better approaches to the treatment~     of chronic pain. In this study, the investigators propose to evaluate in 60 people with~     chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding~     magnitude of pain, physical activity level, and medication status twice daily during this~     period of time. The investigators then will assess the variability in pain levels over time,~     the frequency of flares of osteoarthritis (OA) pain and their relationship to physical~     activity, medications, and clinical descriptors of the population, e.g., age, gender, body~     mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA~     knee pain as well as assessment of subgroups of patients with the overall group being~     studied.~   "
114533|NCT01557218|"~     Intake of vegetables and fruits in preschool children is less than recommended amounts.~     Although offering a variety of foods has been shown to increase intake, this effect has not~     been well studied for low-energy-dense foods. The purpose of this study was to test whether~     increasing the variety of vegetables and fruits served to preschool children affected the~     amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would~     increase both the amount selected and the amount eaten.~   "
114534|NCT01557205|"~     The investigators will obtain human skin specimen (sized approximately 1 cm x 1 cm) for~     dermatological surgical patients in National Taiwan University Hospital, after informed~     consent was obtained. Human skin keratinocytes, fibroblasts, and melanocytes will be~     cultured from the human skin specimen. The three dimensional images of these cultured cells~     will be observed by a ultra-high resolution 3-dimensional optical coherence tomography.~   "
114535|NCT01557192|"~     To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation~     (LFMS) as an antidepressant treatment in subjects with mood disorders.~   "
114536|NCT01557179|"~     This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took~     place at four centers in China. The primary objective of this study was to assess the~     efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the~     current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was~     not inferior to that of estriol cream, with no clinically significant difference between~     them, in the treatment of vaginal dryness symptoms.~   "
114537|NCT01557166|"~     This trial is conducted in North America. The aim of the trial is to investigate the effect~     of liraglutide in obese subjects with sleep apnoea.~   "
114538|NCT01557153|"~     Depression has a high occurrence and causes other problems in older people, two thirds of~     these patients will not have a lessening in their condition from routine treatment~     medication. About half have a form of depression known as 'vascular depression'.~     Augmentation, the addition to, antidepressant treatment with a vascular type of treatment~     (such as a group of medications called Calcium Channel Blocker including the medication~     called amlodipine) may be effective in this group of patients but previously published~     studies have been from highly selected specific patient groups. The investigators would like~     to find out if giving amlodipine medication to people with late life non-responding vascular~     depression would be acceptable to this patient group. The investigators would also like to~     know how they feel while having the treatment and whether this provides a measurable benefit~     for those patients and whether those benefits are relevant to the patients. The~     investigators would also like to find out the information the investigators need to plan and~     prepare for a larger version of this study.~   "
114539|NCT01557140|"~     Chronic Chagas cardiomyopathy causes substantial morbidity and mortality in Latin America.~     Whether RAS inhibitors and beta-blockers are safe and beneficial has been challenged because~     of the lack of formal trials. Hence, the objective of this study was to determine the safety~     and efficacy of renin-angiotensin system (RAS) inhibitors and beta-blockers in chronic~     Chagas cardiomyopathy. This way, the investigators conducted a double-blind,~     placebo-controlled, and randomized trial in 42 patients with Trypanosoma cruzi infection and~     cardiomyopathy. All patients received enalapril (up-titrated to 20 mg BID) and~     spironolactone (25 mg QD). Subsequently, the patients were randomly assigned to receive~     placebo (n = 20) or carvedilol up-titrated to 25 mg BID (n = 19). The primary end points~     were change in left ventricular ejection fraction (LVEF) after RAS inhibition and that after~     the addition of carvedilol. The secondary end points were changes in other echocardiographic~     parameters, Framingham score, quality of life (36-item Short-Form Health Survey), New York~     Heart Association class, radiographic indices, brain natriuretic peptide levels, and~     chemokines as well as safety end points.~   "
114540|NCT01557127|"~     This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate~     the actual dosing of Nexavar in real-life setting vs. the prescribed dose.~   "
114541|NCT01557114|"~     RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association~     with melanoma peptides has been shown as well as synergy between radiation therapy and~     anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant~     effects.Radiotherapy increases tumor immunogenicity in several preclinical models by~     increasing MHC molecules expression and is able to induce significant tumor reduction in~     around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could~     elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens~     (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the~     immune antitumor response. In this therapeutical model, the use of the own patient tumor as~     a source of tumor antigens (in opposition with other vaccination protocols, where TAA are~     exogenic) is particularly adapted.~      PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy~     administered in combination with ipilimumab.~   "
114542|NCT01557101|"~     The purpose of this study is to determine if the adherence to screening in first grade~     relatives of patients with CCR is higher than optical colonoscopy.~   "
114856|NCT01552785|"~     A comparison of three different devices using near infrared spectroscopy to measure the~     regional oxygenation. Both absolute values, reproducibility of measurements and sensitivity~     to changes will be estimated. The study hypothesis is that NONIN EQUANOX 7600 with sensor~     Model 8004CA, INVOS 5100c with sensor SAFB-SM and FORE-SIGHT with medium sensor have similar~     characteristics.~   "
114543|NCT01557088|"~     The majority of the acute coronary events are caused by coronary artery segments with~     minimal luminal disease, but with potentially significant vascular wall inflammation and~     oxidative stress leading to plaque vulnerability. It has become apparent that an initial~     injury at the endothelial surface, is the primary site of the mechanisms involved and a role~     for vascular inflammation and the interaction with oxidative stress continues to emerge.~     Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall~     inflammation that circulates in the blood bound to both low density (LDL) and high density~     (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and~     activity are an independent risk factor for cardiovascular events. Recent studies,~     demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction.~     However, the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary~     arteries, and the contribution of lipoprotein binding to the deleterious potential of Lp-~     PLA2 have not been elucidated. Our working hypothesis is that the endogenous local~     activation of the Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis~     and contributes to the mechanism of coronary endothelial dysfunction and the structural and~     mechanical properties reflecting plaque vulnerability. Thus, the current application will~     characterize prospectively the correlation between the functional, mechanical, and~     structural vascular wall properties, and the systemic as well as the coronary activity of~     the Lp-PLA2 pathway.~   "
114544|NCT01557075|"~     The purpose of this study is to determine whether high dose statin therapy in patients with~     aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and~     were free of the adverse cardiac events during the first 12 months could be superior over~     pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events~     during the additional 12 months.~      Study Design.~   "
114545|NCT01557062|"~     Objectives: To assess the effect of passive body heating on the sleep pattern of patients~     with fibromyalgia.~      Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined~     by the American College of Rheumatology were included. All women underwent passive immersion~     in a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep~     pattern was assessed by polysomnography at the following conditions: pre-intervention~     (baseline), on the first day of intervention (acute), on the last day of intervention~     (chronic) and 3 weeks after the end of interventions (follow-up). Core body temperature was~     evaluated by a thermistor pill at the above-mentioned conditions. The impact on fibromyalgia~     was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.~   "
114546|NCT01557049|"~     The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation~     (GPR) program in subjects with chronic low back pain.~   "
114547|NCT01557036|"~     The primary objective of this study is to further expand the body of clinical knowledge in~     patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for~     intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.~   "
114548|NCT01557023|"~     This trial will study the percentage of women with at least one occurrence of intracyclic~     bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or~     reference drug.~   "
114549|NCT01557010|"~     The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in~     Postherpetic Neuralgia.~   "
114550|NCT01556997|"~     The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination~     drug compared to two other drugs (monotherapies) in controlling hypertension.~   "
114551|NCT01556984|"~     Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators~     hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In~     this study, the investigators will select 200 diabetic patients who have a DSA for diabetic~     foot screening. Also, the investigators will select 100 healthy subjects as controls. The~     endothelial function will be determined by high resolution ultrasound before and after DSA.~     The investigators will observe the changes of endothelial function after DSA assay.~   "
114552|NCT01556971|"~     The objective of this proposed study is to obtain data on the efficacy of Botox in reducing~     symptoms of MDD in male and female patients between the ages of 18 and 65 years old.~      The secondary object is to visually assess each patient's frown before and after the Botox~     injection to determine if there is a correlation between changes in the frown and changes in~     mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will~     be compared to determine if there is a visible improvement in the frown lines corresponding~     to an improvement in the efficacy rating scores.~   "
114553|NCT01556958|"~     The primary goal of the study is to more firmly establish correlations between~     WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including~     spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.~   "
114554|NCT01556945|"~     The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS,~     combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are~     safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines~     can prevent malaria infection.~      The RTS,S vaccine contains a malaria protein in combination with a portion of the~     commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria~     protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are~     done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after~     the 3rd vaccination.~   "
114555|NCT01556932|"~     This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and~     haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an~     effective treatment for nausea and vomiting. The general purpose of this research study is~     to improve the treatment of nausea and vomiting.~   "
114556|NCT01556919|"~     The investigators are looking at a novel approach to measuring gastroesophageal reflux~     disease (GERD) damage and reducing the need for costly and less optimal testing presently~     used for diagnostic and treatment purposes. The investigators will be using three custom~     mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on~     the esophagus.~   "
115117|NCT01549340|"~     The purpose of this study is to determine the proportion of participants that initiate~     allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion~     of participants that persist with their AIT throughout the recommended course.~   "
114560|NCT01556867|"~     At birth, the umbilical cord is cut, separating physically and symbolically the mother of~     his child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus,~     umbilical cord infections constitute a major cause of neonatal morbidity and mortality in~     developing countries. In industrialized countries, omphalitis cases have almost disappeared~     whatever cord care strategies. At this day, care practices appear extremely different~     between countries, based more on habits and convictions that on evidence-based medicine. The~     investigators propose to conduct a non inferiority multicenter clustered crossed randomized~     study. Observations sessions will be performed on two consecutive periods of 5 months: 4~     months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord~     care practice would not expose to a higher risk of omphalitis than antiseptic based care~     approach. The purpose of NEOCORD study is a simplification of cord care for paramedical~     teams and parents, but also a significant reduction of costs in a medico-economic approach.~   "
114561|NCT01556854|"~     The primary objective of this study is to compare effectiveness of five different~     neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and~     piracetam, among patients with acute ischemic stroke.~      The secondary objectives of the study are as follows:~        -  To compare safety of five different neuroprotectents, including butylphthalide,~          edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic~          stroke.~        -  To compare cost-effectiveness of five different neuroprotectents, including~          butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with~          acute ischemic stroke.~   "
114562|NCT01556841|"~     The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in~     extending the time to progression in patients with asymptomatic relapsed platinum resistant~     ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall~     survival times and quality of life.~   "
114563|NCT01556828|"~     The goal of this study is to identify genetic changes associated with the initiation,~     progression, and treatment response of response of cutaneous and hematologic disorders using~     recently developed high-throughput sequencing technologies. The improved understanding of~     the genetic changes associated with cutaneous and hematologic disorders may lead to improved~     diagnostic, prognostic and therapeutic options for these disorders.~   "
114564|NCT01556815|"~     Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular~     carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to~     release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block~     tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable~     HCC may benefit from sorafenib in combination with TACE.~   "
114565|NCT01556802|"~     The investigators will evaluate the National Institute of Health Stroke Scale/Score~     (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo~     for five days, then perform periodic evaluations to determine the status and degree of~     neurological sequelae developed.~   "
114566|NCT01556789|"~     Open label, two part, Phase 1 dose escalation study to evaluate the safety and~     immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated~     Stage 3 or 4 solid tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered~     subcutaneously every two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the~     safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8~     weeks at the Q2W and QW maximum tolerated does/recommended dose (MTD/RD) in cohorts of 15~     patients each.~   "
114567|NCT01556776|"~     CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance~     therapy to that of placebo maintenance therapy in high-risk subjects with Chronic~     Lymphocytic Leukemia (CLL) who have achieved at least a partial response (PR) and either:~        -  MRD levels of ≥ 10-2 or~        -  MRD levels of ≥ 10-4 - < 10-2 combined with at least one of the following factors:~             -  an unmutated IGHV-status~             -  17p-deletion or~             -  TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of~               contraindications to receive Rituximab).~   "
114568|NCT01556763|"~     This study in patients with schizophrenia is designed to provide preliminary evidence of the~     safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2~     doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic~     medication.~   "
114569|NCT01555502|"~     To test the effect of post operative complications on the health related quality of life~     (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer~     (NSCLC).~      The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery)~     using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then~     at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will~     be assessed using the same questionnaires to determine the difference between patients with~     low/no post operative complications to those with high grade post-operative complications.~      Post operative complications will be assess while the patients in the hospital on a daily~     basis using the Clavien classification system for surgical complications.~   "
114570|NCT01555489|"~     The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA)~     plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic~     pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams~     of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial~     test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same~     standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic~     pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as~     front-line treatment. The phase I data suggests that ascorbic acid when given in combination~     with gemcitabine and erlotinib may result in some tumor response, and the goal of this study~     is to better evaluate the response and confirm initial safety data~   "
114571|NCT01555476|"~     This study is designed to assess bioequivalence between one test and one reference~     formulation used for temporary relief of pain. The results will help decide if the new~     medicine is likely to provide pain relief similar to the product being sold.~   "
114572|NCT01555463|"~     The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam,~     15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea~     compared to its vehicle.~   "
114575|NCT01556724|"~     Peripheral nerve blocks are the standard of care for pain management after hip replacement~     surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the~     effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total~     hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the~     standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of~     bupivacaine, is often used in place of bupivacaine due to less motor blockade and less~     severe cardiovascular and central nervous system potential toxicity.~      The primary goal of this study to examine the effect of a low concentration infusion of~     ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36~     hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar~     plexus catheters after primary total hip arthroplasty. Secondary goals are to examine motor~     function, VAS scores and patient satisfaction with pain control in low concentration 0.1%~     ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after~     primary total hip arthroplasty.~   "
114576|NCT01556711|"~     The objectives of the study are to document device performance with respect to the primary~     and secondary endpoints.~   "
114577|NCT01556698|"~     The primary objective of this study is to compare the tolerability, safety and efficacy of~     NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to~     severe acne vulgaris.~   "
114578|NCT01556685|"~     This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine~     the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the~     long term retrospective observational evaluation conducted to measure efficacy, adherence to~     therapy, tolerability, and safety in subjects with relapsing MS related to antibody status~     and treatment.~   "
114579|NCT01556672|"~     This study will determine the prevalence of small bowel lesions suggestive of Crohn's~     disease (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy.~     The study also aims to determine if the treatment of psoriasis with adalimumab will have an~     effect on the healing of the small bowel for patients who have lesions suggestive of CD.~      Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the~     exact prevalence of CD in patients with psoriasis at this time is unknown as many patients~     probably have undiagnosed disease as the early signs will often cause no symptoms. CD is~     therefore receiving very little attention from dermatologists who are treating patients with~     psoriasis. For example, very few dermatologists will actively question patients with~     psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By~     the time the diagnosis is made and patients receive their first treatment, they may already~     have significant fibrosis and stenosis of the intestine. Current treatments, including~     adalimumab, cannot reverse small bowel anomalies to normal in the presence of fibrosis.~     Therefore, many patients with a late diagnosis will still have symptoms or will eventually~     require surgery despite good control of the inflammation. Treatment of CD should start as~     early as possible, as early treatment has been associated with an increased rate of complete~     healing. Complete control of the disease at its early stages may prevent complications.~   "
114580|NCT01556659|"~     Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST~     segment elevation myocardial infarction (STEMI). It is a feared complication since it might~     increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin~     K antagonist treatment in these patients. However patients with STEMI nowadays undergo~     primary percutaneous coronary intervention (PCI) with coronary stent placement and~     consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent~     stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with~     triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and~     vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a~     strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet~     therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings~     are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective~     analysis did not show any beneficial effects of addition of vitamin K antagonist to dual~     anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted,~     morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized~     trial is warranted to address this issue.~      Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of~     the study is to determine in a randomized fashion the risks and benefits of the addition of~     vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in~     patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or~     baseline Magnetic Resonance Imaging (MRI).~   "
114581|NCT01556646|"~     Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related~     quality of life in cirrhotic patients with hyponatremia~   "
114582|NCT01556633|"~     This open-label, prospective, single dose study will evaluate the pharmacokinetics and~     safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a~     creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of~     Tamiflu.~   "
114583|NCT01556620|"~     We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical,~     USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra~     Neurosciences, USA) and that values are correlated.~   "
114584|NCT01556607|"~     The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled~     by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.~   "
114599|NCT01556412|"~     Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically~     affecting middle aged men and is frequently associated with inflammatory bowel disease.~     Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical~     challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography~     (ERC) or percutaneous liver biopsy are needed when magnetic resonance~     cholangiopancreaticography remains inconclusive. As these procedures are associated with~     significant risks for the patient, the goal of this study is to evaluate, if endoscopic~     ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.~   "
114600|NCT01556399|"~     The purpose is to investigate whether polyps that look different at endoscopy, have formed~     via different mutations and have different risks of turning into cancer.~   "
114585|NCT01556594|"~     Hypoglycemia is common in people with type 1 diabetes. Mild and moderate hypoglycaemia is~     normally treated by consuming oral carbohydrates. During an episode of severe hypoglycaemia~     however, the person with diabetes is unable to consume carbohydrates and requires help from~     another person. The current standard treatment for severe hypoglycemia is intravenous~     glucose or an injection of glucagon, which causes an increase of blood glucose, which allows~     the person with diabetes to recover sufficiently to consume carbohydrate.~      AMG Medical is investigating a novel formulation of glucagon which may be easier to~     administer than the currently available glucagon formulations.~      In this study, patients with Type 1 diabetes will receive injected insulin to reduce their~     blood glucose, and will then receive one of three doses of the new glucagon formulation or a~     dose of glucagon for injection, and their blood glucose will be measured for 3 hours.~      The study hypothesis is that the new glucagon formulation will be as effective as the~     current injected formulation at raising blood glucose levels within 15 minutes.~   "
114586|NCT01556581|"~     The primary purpose of this study is to compare the effectiveness of two management~     strategies for patients with a recent onset of low back pain (LBP). One is based on usual~     care and the other is based on early access to physical therapy following a pragmatic~     treatment-based classification approach. The secondary purposes are to compare the~     subsequent healthcare utilization associated with two management strategies as well as to~     evaluate the importance of psychosocial factors on outcomes within both groups of treatment.~     The overall hypothesis guiding the study is that the additional initial treatment expense~     incurred by early implementation will result in superior short-term clinical effectiveness,~     and will be more cost-effective in the long-term due to reduced healthcare utilization. We~     will also explore the importance of psychosocial factors on outcomes within both treatment~     groups, which may provide insights for further improving treatment strategies.~   "
114587|NCT01556568|"~     The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK~     activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk~     pathway that lead to MEK activation, would be beneficial over a 6 month treatment period in~     hypertrophy regression.~   "
114588|NCT01556555|"~     This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing~     cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP).~     Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication~     for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy~     using Spyglass direct visualization system. Clinical data on all patients will be collected~     at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and~     inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.~      A structured data collection form including information on Majoie Score, macroscopic~     features of the bile ducts at cholangioscopy, quality of the investigation, technical~     difficulties, and an overall judgment of whether any abnormalities observed were benign or~     malignant was completed by the endoscopist in conjunction with the procedure.~   "
114589|NCT01556542|"~     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty~     followed by nitinol stent implantation versus nitinol stent implantation in superficial~     femoral artery and popliteal artery stenosis.~   "
114590|NCT01556529|"~     The CDRM study will evaluate a newly developed approach to improve management and secondary~     prevention in diabetes care. The research will explore the impact of an medical care~     intervention via a computer-assisted diabetes risk management system (CDRMS) on compliance~     and outcome The focus will be on the effect on patients' diabetes and diabetes complication~     risk profiles, medical effectiveness and patients- reported outcomes.~   "
114591|NCT01556516|"~     This study explores the outcome and effect of pregnancy on Pompe Disease. The results are~     expected to guide clinicians in counseling and care of women with Pompe disease, who are~     planning to become pregnant, and during the pregnancy.~   "
114592|NCT01556503|"~     The purpose of this study is to show how well a new device, confocal microscope, works to~     detect malignant melanoma, a type of skin cancer.~   "
114593|NCT01556490|"~     The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable~     hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All~     patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.~   "
114594|NCT01556477|"~     The proposed phase II trial is a multicenter, randomized, open-label study that will~     evaluate the efficacy and safety of azacitidine alone or in combination with lenalidomide in~     high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype~     including del(5q). The primary objective will be to evaluate the efficacy in terms of~     response according to International Working Group (IWG) criteria for MDS and AML after 6~     cycles of azacitidine or azacitidine + lenalidomide treatment, or at end of study if this~     occurs at an earlier time point.~   "
114595|NCT01556464|"~     This study will test the following hypotheses:~        1. Treatment of newly diagnosed Obstructive Sleep Apnea (OSA) in acutely ill patients with~          auto-adjusting Continuous Positive Airway Pressure (CPAP) would result in fewer~          in-hospital complications, as compared to no treatment (primary outcome).~        2. Treatment of newly identified OSA in acutely ill patients with auto-adjusting CPAP~          would result in shorter length of stay, lower re-admission rate, better blood pressure~          (BP) control, better long term compliance with OSA treatment, as compared to no~          treatment (secondary outcomes).~   "
114596|NCT01556451|"~     This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean~     adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be~     enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical~     hypothesis testing will be conducted in the study.~   "
114597|NCT01556438|"~     The purpose of this study is to evaluate the safety and effect on the body of LY2127399 in~     combination with bortezomib and dexamethasone in Japanese patients with relapsed or~     refractory multiple myeloma (MM).~   "
114598|NCT01556425|"~     In this 5-year study, the investigators propose to evaluate the separate and combined~     effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and~     employment-based reinforcement of opiate abstinence in promoting opiate abstinence and~     reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug~     users.~   "
114602|NCT01556373|"~     This study aims to assess the effect of acute inflammation on arterial stiffness and~     microcirculation. Patients with severe sepsis will be compared with age-, sex- and~     cardiovascular risk factors-matched controls.~      The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures~     are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate,~     cardiac output, left ventricular ejection fraction, systemic vascular resistances), central~     hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index),~     thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen,~     C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of~     metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).~   "
114603|NCT01556360|"~     The purpose of this study is to describe bone status on patients with genetic~     hemochromatosis, at diagnostic time and his evolution under treatment.~   "
114604|NCT01556347|"~     Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies)~     to other human tissues via pregnancy, transfusions or previous transplantation, which limits~     the ability to find an acceptable donor heart for transplantation. Such patients are at high~     risk for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For~     successful transplantation, patients must receive organs from donors who lack the HLA~     antigens that correspond to their alloantibody specificities. No successful desensitization~     strategy currently exists.~      Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug~     approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively~     eliminate or significantly reduce alloantibody levels and permit highly sensitized patients~     to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and~     will require re-immunization.~   "
114605|NCT01556334|"~     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin~     or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result~     in stomach upset in some patients, causing them to stop taking the medication. Therefore,~     azithromycin is often prescribed instead. Azithromycin is usually taken only once and~     stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a~     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin)~     in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The~     working hypothesis is that there is no difference in the clinical effectiveness between~     antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging~     latency in PPROM.~   "
114606|NCT01556321|"~     Green tea may have positive effects for weight control and on body composition via several~     approaches such as a positive effect on the gut flora, a decrease in fat absorption from the~     intestines and an increase in resting energy expenditure.~   "
114607|NCT01556308|"~     Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis~     characterized by spontaneous or post traumatic large cutaneous blisters. No curative~     treatment is actually available. Some data suggest a role of inflammation in the occurrence~     of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in~     DM-EBS.~      Material and methods: A first retrospective immunohistochemical study will be led on~     remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical~     multicentric prospective study will be led on 8 patients older than 1 year with severe~     DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In~     case of flare of the disease, the liquid and the top of the blisters will be took. Samples~     will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid~     blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated~     Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with~     Luminex® technical with a multiplex targeting cytokines and chemokines. An~     immuno-histochemic analysis in association with a quantitative PCR will be made on the top~     of the blisters. If unknown, genotypic study will be made.~      Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer~     new therapeutic ways.~   "
114608|NCT01556295|"~     The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior~     among nurses with low back pain using validated measures and compare the findings to those~     from nurses without back pain.~   "
114609|NCT01556282|"~     Therasphere will be administered via catheter through the Hepatic Artery to treat patients~     with Hepatocellular Carcinoma and Portal vein Thrombosis.~   "
114610|NCT01556256|"~     This randomized trial studies how well music therapy and parents' education work in~     improving communication, emotional distress, and recovery in adolescents/young adult~     patients undergoing treatment for high-risk cancer and their parents. Making a music therapy~     video may improve communication, emotional distress, and recovery in younger patients~     undergoing treatment for cancer. It is not yet known whether music therapy and counseling~     for parents is more effective than information handouts for parents in improving~     communication and emotional distress in patients undergoing treatment for cancer.~   "
114611|NCT01556243|"~     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer~     and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x~     rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation~     therapy work in treating patients with multiple ipsilateral breast cancer~   "
114612|NCT01556230|"~     This project is the first comprehensive prospective study of clinically non-functioning~     pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of~     100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic~     and do not require surgery; Group II will consist of 250 patients who have pituitary lesions~     that are symptomatic and require surgery. Patients will be followed with a series of~     endocrine laboratory testing, physical examinations, testing of quality of life and~     neurocognitive function before and serially over time either during non-surgical management~     or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary~     magnetic resonance imaging (MRI) studies and visual field testing being done over time~     during follow up as part of clinical care will be collected.~   "
114613|NCT01556217|"~     The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in~     the blood and cerebrospinal fluid of healthy adult volunteers following administration of a~     single dose of JNJ-39393406.~   "
114615|NCT01556191|"~     Lung Cancer is to become the first cause of death related to cancer in France as it's~     already the case in United States. At Present, Lung Cancer in women and in men is treated~     similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities~     : at the time of the diagnosis female patients are younger, there are less clinical signs,~     clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is~     weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism).~     Response rate to chemotherapy is better. Prognosis is better~      Numerous hypotheses have been put forward to account for the specific characteristics of~     female lung cancer described above.~        -  One hypothesis is that there are different genetic anomalies in women. Some studies~          show an increase of EGFR mutation and HER2 expression and a decrease of expression of~          repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to~          tabagism and to chemotherapy.~        -  Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer~          presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual~          cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer~          incidence and on survival of lung cancer in women. Cellular and animal models show that~          ER pathway is activated in lung cancer and participates in oncogenesis.~        -  Moreover an interaction between RE and EGFR pathway has been demonstrated on lung~          cancer cell lines and mouse models.~      EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib)~     and in women with EGFR mutations (with gefitinib). In this study, the use of these two~     treatment will be in accordance with their market authorisations.~      The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to~     EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates~     its breakdown. It has a market authorisation in breast cancer. Furthermore the association~     between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between~     RE and EGFR pathways .~   "
114616|NCT01556178|"~     In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other~     molecules such as proteins and nucleic acids. In patients with central nervous system (CNS)~     and other conditions, the levels of these molecules may be altered. In several other studies~     at our institution, the investigators are investigating such molecules in tumor specimens as~     well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However,~     these levels are difficult to interpret without comparing them to levels in patients without~     CNS tumors. The investigators propose a study to collect small amounts of blood and~     cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a~     diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.~   "
114617|NCT01556165|"~     Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy~     in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in~     levodopa-treated PD patients with motor fluctuations.~      The rationale for conducting this study is to evaluate the efficacy, tolerability, and~     safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.~   "
114618|NCT01556152|"~     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent~     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,~     and costs from a public health perspective. Painful diabetic neuropathy affects 16% of~     patients with diabetes. Pharmacological agents used in the management of painful DPN mainly~     include tricyclic antidepressants, selective serotonin and norepinephrine reuptake~     inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and~     pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of~     painful DPN. Generally, the available treatment options do not give total relief, are not~     effective in all patients, and only about one-third of patients may achieve more than 50%~     pain relief. Hence newer therapies are required for the treatment of DPN.~      This is randomized, double-blind, placebo-controlled, parallel group study. The study will~     include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to~     DPN for least 6 months and no greater than 5 years.~      Patients will be recruited after providing written informed consent.~   "
114619|NCT01556139|"~     The reduction in effort tolerance as result of a decreased efficiency in ventilation is~     common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF)~     (Ribeiro, Frankenstein). One of the most common cause is the reduced respiratory muscle~     strength and endurance. Some studies have evaluated the effect of a specific training on the~     muscular strength both in pulmonary (Battaglia, Powell) and cardiac patients (Winkelmann,~     Chiappa). Moreover, only few studies investigated a specific training for such patients~     (Koppers, Sherer) because of the complicated equipment needed to prevent hypocapnia. Up to~     date, portable and economic systems for isocapnic hyperpnea have been developed for~     respiratory muscle training.~      Primary aim of the study was to evaluate the effectiveness of the respiratory muscle~     training -by the technique of the isocapnic hyperpnea- on the effort tolerance and endurance~     in patients with COPD and CHF~      Secondary aims were: A.to quantify the number of patients with deficit of respiratory~     muscles endurance and B.to verify different response of training between COPD and CHF~     patients~   "
114620|NCT01556126|"~     The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting~     Stent, in patients comparable to the everyday's clinical practice population, with a~     specific focus on diabetics, that will be part of a pre-specified study subgroup.~   "
114621|NCT01556113|"~     To explore whether there is a different response to omega-3 fatty acid rich diet with~     respect to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the~     rs738409 minor allele (GG) and the common allele homozygous (CC) of PNPLA3.~      Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will~     lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention~     than the common allele homozygous supplementation.~   "
114622|NCT01556100|"~     A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years~     of age may be eligible for this study. Candidates are screened with a medical history and~     physical examination, and blood test.~   "
114623|NCT01556087|"~     The investigators propose that inability to tolerate the distress of opioid withdrawal and~     the negative affect associated with early abstinence are key factors in early illicit opioid~     lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing~     distress tolerance is designed to increase treatment adherence.~   "
114624|NCT01556074|"~     The primary objective of this preliminary study is to estimate sleep outcome effect sizes~     and determine feasibility for a novel yoga treatment of insomnia in participants with post~     traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of~     sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible~     mechanisms of action.~   "
115078|NCT01549860|"~     This trial is a prospective, randomized, controlled, multi-center study of subjects~     presenting with chronic lower extremity venous ulcers. The study will evaluate the safety~     and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of~     Care (SOC) alone in the treatment of lower extremity venous ulcers.~   "
114626|NCT01556048|"~     The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed~     public health problem for which are no empirically supported treatments. The purpose of this~     application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well~     supported, stand alone intervention for depression and recently applied to posttraumatic~     stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart~     access to natural rewarding contingencies and resources. The treatment focuses on promoting~     stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with~     pleasurable activities and significant social resources. Rumination, disengagement, and low~     self-efficacy are defining features of PG. Further, in response to loss of intimates, the~     key factors that differentiate resilient people from those that have difficulties adapting~     is the maintenance or fast resumption of social and occupational functioning. Thus, the main~     hypothesis of this study is that BA for PG will result in clinically significant reductions~     in rumination and functional disengagement. This is a preliminary small-scale pilot~     assessment of potential efficacy and feasibility of completing a large scale study of BA for~     PG.~   "
114627|NCT01556035|"~     In spite of high initial response rate after a first line treatment by R-polychemotherapy,~     cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the~     patients with PCBCL-LT. Thereafter there is no consensus concerning patients care:~     radiotherapy has only a palliative effect, advanced age often limits using more aggressive~     chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing~     cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an~     antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic~     properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse~     large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these~     results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it~     has a manageable toxicity even in advanced age patients.~      If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its~     evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.~   "
114628|NCT01556022|"~     This is a prospective, randomized, placebo-controlled, double blind safety and feasibility~     clinical trial.~   "
114629|NCT01556009|"~     The purpose of this study is to evaluate and compare the safety and efficacy of intermittent~     vismodegib and of Photodynamic Therapy (PDT).~   "
114630|NCT01555996|"~     This is a randomized, controlled trial to compare the efficacy of two strategies of~     non-pharmacological prevention of delirium in critically non-ventilated older patients:~        -  standard non-pharmacological prevention~        -  intensive nonpharmacological prevention (standard non-pharmacological prevention plus~          early and intensive occupational therapy).~   "
114631|NCT01555983|"~     This study will demonstrate that vaporized marijuana results in antinociception when~     compared to placebo in subjects with spinal cord injury. To further evaluate potential~     benefits and side effects, the effect of different strengths of cannabis on mood, cognition,~     and psychomotor performance will also be measured.~   "
114632|NCT01555970|"~     The primary objective of this study is to determine if N-Acetylcysteine (NAC) has efficacy~     as an augmentation agent in the treatment of treatment-resistant obsessive-compulsive~     disorder (OCD). The investigators predict that NAC will reduce OCD symptoms after sixteen~     weeks of add-on treatment as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).~   "
114633|NCT01555957|"~     The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC~     in late preterm and term neonates with major GI surgical disorders~   "
114634|NCT01555944|"~     This is an open, multicentre, prospective observational (non-interventional) study,~     performed in Belgium.~      Principal objectives:~        1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as~          routinely evaluated) before treatment with anthracyclines of patients with metastatic~          breast cancer (MBC) aged > or = 65 years~        2. To observe the management of cardiovascular risk during and after anthracycline~          treatment~        3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac~          function, outcome and quality of life (EORTC QLQ-C30)~      Secondary objectives:~        1. To evaluate the efficacy of anthracyclines on progression free survival and tumor~          response as routinely measured (e.g. recist criteria, tumor markers and other exams)~        2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection~          fraction, heart failure and rate according to allocated treatment.~        3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30~          criteria or Karnofsky index is achieved in the various patient subgroups~        4. To correlate the therapeutic choice and posology of anthracyclines for MBC with~          Cardiovascular risk at baseline~        5. To calculate the cardiovascular risk according to SCORE~   "
114635|NCT01555931|"~     This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed~     their infant for at least 6 months and desire to use the LNG-IUS as their primary~     contraceptive method postpartum. The investigators will compare the frequency of~     breastfeeding among women receiving the levonorgestrel-releasing intrauterine system~     (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators~     hypothesize there will be no difference in breastfeeding prevalence between the two groups.~   "
114636|NCT01555918|"~     The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole~     (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after~     single-dose and steady state (multiple-dose) administration of isavuconazole BAL8557 in~     healthy Chinese subjects.~   "
114637|NCT01555905|"~     Inspiratory Muscle strength training (IMST) will significantly improve maximal inspiratory~     pressure and pulmonary function in patients with neuromuscular disease and respiratory~     muscle contractile dysfunction.~   "
114669|NCT01555229|"~     Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above~     the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia.~     Subglottic secretion drainage can be either continuous or intermittent. However, concerns~     about the safety of continuous subglottic secretion drainage were raised in an experimental~     study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our~     objective is therefore to compare intermittent versus continuous subglottic secretion~     drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an~     expected duration of more than 24 hours.~   "
114638|NCT01555892|"~     Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or~     T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which~     has come back, is at risk of coming back, or has not gone away after treatment, including~     the best treatment we know for these diseases.~      Some patients with Lymphoma or T/NK-lymphoproliferative disease or CAEBV show signs of virus~     that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono~     or the kissing disease) before or at the time of their diagnosis. EBV is found in the~     cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role~     in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV)~     infected by EBV are able to hide from the body's immune system and escape destruction. We~     want to see if special white blood cells, called GRALE T cells, that have been trained to~     kill EBV infected cells can survive in the blood and affect the tumor.~      We have used this sort of therapy to treat a different type of cancer that occurs after bone~     marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the~     tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the lab that~     recognized all 9 proteins and were able to successfully prevent and treat post transplant~     lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor~     cells and B cells only express 4 EBV proteins. In a previous study, we made T cells that~     recognized all 9 proteins and gave them to patients with HD. Some patients had a partial~     response to this therapy but no patients had a complete response. We then did follow up~     studies where we made T cells that recognized the 2 EBV proteins seen in patients with~     lymphoma, T/NK-lymphoproliferative disease and CAEBV. Those proteins are called LMP-1 and~     LMP-2. The cells are called LMP-specific cytotoxic T-Lymphocytes (CTLs). We have treated~     over 45 people on those studies. About 63% of those patients who had disease at the time~     they got the cells had responses including some patients with complete responses. This study~     will expand on those results and we will try and make the T cells in the lab in a simpler~     faster way. We will also make T cells that will still see the LMP proteins but also 2 other~     EBV proteins called EBNA-1 and BARF. These cells are called GRALE T cells. These GRALE CTLs~     are an investigational product not approved by the FDA.~      The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T~     cells created using this new manufacturing technique. We will learn what the side effects~     are and to see whether this therapy might help patients with HD or NHL or EBV associated~     T/NK-lymphoproliferative disease or CAEBV.~   "
114639|NCT01555879|"~     The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical~     practice. The main hypothesis to be examined in this study is, Abatacept's effectiveness~     results in a single real-world clinic (n = 100) are reproducible at another site (n ~=~     200).~   "
114640|NCT01555866|"~     This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the~     pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics~     in healthy subjects with normal renal function.~   "
114641|NCT01555853|"~     This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of~     paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients~     with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well~     tolerated therapies are needed to treat patients with relapsed and refractory lymphomas.~     Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the~     anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and~     may be an effective treatment for lymphoma.~   "
114642|NCT01555840|"~     A capsule steered by magnetic field force developed by Siemens and Olympus has recently been~     evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N,~     Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of~     stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun~     30.18). This blinded prospective study investigates the accuracy of the magnetically guided~     capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric~     symptoms and indication for upper GI Endoscopy.~   "
114643|NCT01555827|"~     A few studies suggest that patients suffering from neurodegenerative diseases (such a~     multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal~     nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain~     optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye,~     offers a precise and standardized estimation of this parameter, which could constitute a~     biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest~     sign of AD, prior to damage of the hippocampal region that impacts memory.~      Besides, some associations of AD with some degenerative diseases of the eye (glaucoma,~     microvascular abnormalities, age-related macular degeneration (AMD)) have also been~     reported.~      It therefore seems interesting to determine whether RNFL thickness, and other ocular~     parameters, may give some indications for a better detection of AD and cognitive decline in~     the elderly.~   "
114644|NCT01555814|"~     The investigators want to relate disturbances in first-episode schizophrenic patients in~     (dopaminergic) D2 receptors, brain structure, brain function, and information processing to~     each other and to psychopathology. Additionally, the investigators want to examine the~     influence of D2 receptor blockade on these disturbances. The investigators expect~     disturbances in the dopaminergic system at baseline to correlate with specific structural~     and functional changes and with disruption in information processing as measured with~     psychophysiological and neurocognitive methods - and investigators expect D2 receptor~     blockade to reverse some of the functional and cognitive impairments. The investigators do~     not expect any effect of treatment on brain structure.~   "
114645|NCT01555801|"~     Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the~     choices of treatment. At present, the main diagnostic method for early esophageal cancer is~     endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is~     necessary to improve endoscopic ultrasound examination methods. This project is concerning~     on the efficacy of EUS combining with submucosal injection of saline for staging T1a and~     T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early~     esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group~     (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All~     the cases will be performance by endoscopic or surgical resection; postoperative pathologic~     diagnosis will be obtained involving echo, depth, margin and other features. The EUS results~     of two groups of patients will be compared with pathologic results. From comparison, the~     efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will~     be validated. Through this study, the investigators may develop a routine diagnostic and~     accurately staging method for early esophageal cancer patients.~   "
114646|NCT01555788|"~     The primary purpose of this pilot study is to test an artificial pancreas system which uses~     the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.~   "
114704|NCT01554774|"~     Many studies have evaluated the viability of measuring the pulmonary vascular resistance~     (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary~     thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found~     other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that~     in patients with COPD, the severity of obstruction, expressed by GOLD class, is associated~     with an increase of PVR.~   "
114647|NCT01555775|"~     The aim of this study is to assess the effect of ingesting a commercial carbohydrate and~     protein dietary supplement in powder form (P-CHO supplement) or a milk shake with skimmed~     milk, strawberries and banana (MS), after resistance exercise, in muscle damage, oxidative~     stress, inflammation and functional recovery. It is hypothesised if the ingestion of a milk~     shake with skimmed milk and fruit (strawberry and banana) has the same impact on markers of~     muscle damage, oxidative stress, inflammation and functional recovery induced by resistance~     exercise, as the intake of a commercial powder with the same CHO and protein amounts.~      Fifteen adult athletes from the Portuguese Athletic Federation will complete 2 trials~     separated at least by 2 weeks. Alternate legs and drinks will be used in each trial and~     participants will be overnight-fasted. This study will have a single-blind, randomized,~     crossover, repeated-measures experimental design. In each trial, after warm-up, the~     eccentric peak torque of the knee joint extensors will be determined using an isokinetic~     dynamometer. After this, participants will complete an isokinetic exercise until exhaustion~     at a constant angular velocity of 60° • s-1. After the exhaustion protocol, athletes will~     perform again the peak torque determination. Immediately after, participants will drink the~     P-CHO supplement or MS during the first 2 h. Both drinks will contain 0.8-1.2 g~     carbohydrates • kg-1 • h-1 and 0.2-0.4 g protein • kg-1 • h-1. Twenty four and 48 h after~     the exhaustion protocol participants will return to the laboratory to repeat the peak torque~     determination. Blood samples will be collected before warming-up, immediately and 2 h after~     the last peak torque determination and 24 h and 48 h after. Serum samples will be analyzed~     for creatine kinase, lactate dehydrogenase, interleukine-6, protein carbonyls and total~     antioxidant status. The delayed onset muscle soreness, using a visual analogue scale, and~     girths will be measured at the same moments as blood sampling. Two-way repeated-measures~     ANOVA will be used for statistical analysis of the data.~   "
114648|NCT01555762|"~     This multicenter, prospective, observational study will evaluate the efficacy and safety of~     Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal~     cancer. Data will be collected from eligible patients for24 months.~   "
114649|NCT01555749|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered~     subcutaneously, at two different dose levels, in healthy Japanese subjects.~   "
114650|NCT01555736|"~     Specific immunotherapy, which involves the administration of allergic extracts to patients~     with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology.~     According to the latest studies immunotherapy not only reduces symptoms' severity but also~     may modify the course of allergic disease by reducing the risk of new sensitisations and~     development of more advanced stages of the disease.It has been hypothesized basing on~     clinical observation that perennial immunotherapy is more effective and safer in comparison~     to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial~     and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.~   "
114651|NCT01555723|"~     Background: Treatment of HIV-1 infected Ugandan children with antiretroviral therapy (ART)~     is increasing but few prospective long-term studies evaluating the treatment process have~     been reported. In this study we sought to determine prospectively how consistent monitoring~     of HIV-1 RNA levels impacts the ART treatment process.~      Methods: One hundred and eight children initiating ART were enrolled into this study. These~     children had comprehensive laboratory monitoring including HIV-1 RNA level determination and~     genotype analysis (where appropriate), CD4 % plus absolute counts, and safety laboratory~     measurements performed prior to starting therapy and at regular intervals after receiving~     ART. Kaplan-Meier statistics were used to examine predictors of survival and virologic~     failure. Viral genotype analysis was performed on samples obtained from children having~     virologic failure to determent the emergence of mutations.~   "
114652|NCT01555710|"~     This is a multinational, multicenter, randomized controlled, open-label, adaptive study to~     evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with~     extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and~     Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio~     to receive either PaCE or CE chemotherapy.~      The study design uses an adaptive group sequential approach with sample size re-estimation~     at the interim analysis.~      Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and~     disease-related symptoms. Tumor-related endpoints will be assessed according to the Response~     Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.~      The safety of study treatments will be assessed by the frequency and severity of adverse~     events as determined by National Cancer Institute (NCI) Common Terminology Criteria for~     Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim~     analysis of safety data only will be performed.~      An independent Data Monitoring Committee (DMC) will be convened to assess the safety and~     efficacy of the study interventions and to monitor the overall conduct of the clinical~     trial.~   "
114653|NCT01555437|"~     Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical~     presentation can vary considerably. Patients are frequently assessed by capsule endoscopy~     (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the~     correlations between CE scoring index (CESI), biological markers, and disease activity~     indices remain undefined.~      Methods: A prospective study was conducted between October 2008 and February 2011 on 58~     established SBCD patients and suspected patients who received a definitive SBCD diagnosis~     during study. Patients underwent complete CE, and were scored according to the CESI~     (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and~     Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein~     (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the~     patients underwent CE with scoring for CESI, HBI, and CRP.~   "
114654|NCT01555424|"~     The investigators hypotheses is that the consumption of the investigators vitamin D~     fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older~     institutionalized adults. Also, the consumption of the cheese with the higher amount of~     vitamin D will result in an improvement in wellbeing scores.~   "
114655|NCT01555411|"~     Akershus Cardiac Examination (ACE) 1950 Study will be a large, observational, prospective,~     longitudinal, population-based cohort study. The overall aim is to establish an extensive~     cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal~     long-term follow-up studies of cardiovascular and cerebrovascular disease.~   "
114656|NCT01555398|"~     The purpose of this study is to evaluate the effect of food on the pharmacokinetic~     characteristics of fenofibric acid for HIP0901 capsule.~   "
114657|NCT01555385|"~     The aim of the study is to investigate the influence of nutritive (high-protein or~     high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and~     physiological responses of mental workload during multitasking in healthy volunteers.~   "
115079|NCT01549847|"~     This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle~     fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.~   "
114659|NCT01555359|"~     Autologous hematopoietic cell transplantation (HCT) is a treatment strategy used as advanced~     line therapy for different malignancies, mainly hematological. Its main advantage lies in~     the ability to provide hematologic and immune rescue after high dose chemotherapy therapy.~     The first requirement of a successful transplantation is recruitment of sufficient amount of~     cells. This is achieved by mobilizing CD34+ stem cells from the bone marrow to the~     peripheral blood, by G-CSF priming, and then harvesting the cells from the peripheral blood~     at the right timing by means of apheresis. Currently, the decision on the optimal collection~     timing is based on the pre-collection CD34 cells blood concentrations.~      The investigators goal is to investigate whether telomerase, the telomere elongation enzyme,~     which constitutionally and solely expressed in progenitor cells, is correlated with~     collection and post HCT engraftment characteristics.~      The investigators will collect blood from patients when starting GCSF and on the day of~     planned apheresis. Pearson correlation test will be used to correlate between telomerase~     activity in the samples and with collection and engraftment characteristics.~   "
114660|NCT01555346|"~     Whole blood samples will be collected from high-risk pregnant women to validate the clinical~     performance of the SEQureDx Trisomy 21 Test.~   "
114661|NCT01555333|"~     This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are~     currently participating in Protocol 2202 into a long-term study in which all subjects will~     receive active drug (arbaclofen).~   "
114662|NCT01555320|"~     CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in~     treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria,~     the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided~     into two groups (treatment and control group) by central randomization service. The~     treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag)~     three times a day in addition to standardized western medications. Whereas the control group~     will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in~     addition to standardized western medications. Efficacy indicators include primary indicator~     (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause~     death, emergency/re-admission to hospital due to HF, frequency of re-admission due to~     cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock,~     revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.;~     Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function~     classification; Minnesota life quality scale; scores from the four traditional chinese~     medicine (TCM) diagnostic methods). Other indicators include blood cholesterol,~     triglyceride, high density cholesterol and low density cholesterol. Safety indicators~     include blood pressure, heart rate, blood and urine routine tests, liver and renal function~     tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will~     receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd,~     6th, 9th, 12th month after recruitment. All patients will be followed up until the end of~     study (Refers to the 12th month of the last case recruited into the study).~   "
114663|NCT01555307|"~     The purpose of the study was to evaluate the effectiveness of balance exercises added to~     typical joint range of motion and muscle strengthening exercises on balance in patients~     following total hip or knee joint arthroplasty~   "
114664|NCT01555294|"~     Multiple risk factors contribute to atherosclerosis, which ultimately results in clinical~     manifestation of cardiovascular disease. Atherosclerosis results in both functional and~     morphological changes in the vessel wall, which can be measured by ultrasonography. The~     current study has been designed to~        1. To evaluate whether non-invasive measurements of atherosclerosis are independent~          predictors of cardiovascular disease and~        2. to delineate new biochemical parameters and genetic variations, allowing earlier and~          more effective preventive therapy~        3. The investigators intend to set guidelines for use of NIMA in an outpatient setting to~          facilitate early detection of increased cardiovascular risk and monitor life-style and~          pharmaceutical interventions.~      In both the general population and in Familial Combined Hyperlipidemia.~   "
114665|NCT01555281|"~     There is a great need for treatment options in patients with multiple myeloma (MM) after~     failure of the lenalidomide/dexamethasone regimen as there is no established standard active~     therapy for these patients.~      Combining nelfinavir, a drug targeting both the proteasome and PI3K/Akt pathway, with~     lenalidomide, may restore lenalidomide-sensitivity to the disease as has been shown in vivo~     for the PI3K/Akt inhibitor perifosine and the proteasome inhibitor bortezomib.~      Patients expected to be included in the trial are heavily pretreated and might not be~     candidates for further intensive therapies. The combination of nelfinavir with~     lenalidomide/dexamethasone offers also to these patients an alternative. Preliminary~     experiences in another SAKK trial with the combination of bortezomib and nelfinavir are~     positive with few side effects with nelfinavir doses of up to 1875 mg twice daily (bid). For~     the phase I part of the trial a starting dose of 1250 mg nelfinavir bid was chosen, since~     the necessary plasma concentration of nelfinavir will not be reached with lower doses.~      In case of progression during or after the trial treatment any other lenalidomide- or~     bortezomib-based chemotherapy combination could be an option for the patient. However, the~     addition of a chemotherapeutic drug like cyclophosphamide or doxorubicin has known side~     effects like hematological toxicities, nausea, vomiting and hair loss.~      The aim of this trial is to demonstrate that the combination of nelfinavir with~     lenalidomide/dexamethasone is safe (phase I, dose escalation of nelfinavir) and active~     (phase II). Patients who do not respond to trial medication will stop trial treatment after~     4 months of therapy at the latest.~      If the combination of nelfinavir with lenalidomide/dexamethasone should prove to be safe and~     efficient in treatment of lenalidomide-refractory MM, this would be the first orally~     available treatment for these patients and establish a new class of drugs (human~     immunodeficiency virus (HIV) protease inhibitors) as active antineoplastic agents in MM. In~     addition this would establish the concept of re-sensitizing patients to lenalidomide~     therapy and demonstrate the effect of nelfinavir on proteasomal degradation and Akt~     phosphorylation in cancer patients in vivo.~   "
114666|NCT01555268|"~     This phase I trial studies the side effects and the best dose of trebananib when given~     together with or without low-dose cytarabine in treating patients with acute myeloid~     leukemia (AML). Trebananib may stop the growth of AML by blocking blood flow to the cancer.~     Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     trebananib together with cytarabine may be an effective treatment for patients with AML.~   "
114667|NCT01555255|"~     This study seeks to determine whether screening pregnant women for malaria with malaria~     rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth~     outcomes due to malaria in areas of varied malaria transmission in Africa.~   "
114668|NCT01555242|"~     This is a phase I, open-label, multiple dose, dose escalation study to assess the safety,~     tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally~     in patients with advanced cancer and lymphomas.~   "
115080|NCT01549834|"~     This is an efficacy and safety study evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease.~   "
114670|NCT01555216|"~     Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of~     postoperative pain control included oral narcotics, single injection regional techniques and~     more recently continuous nerve catheters. Recent studies have demonstrated a benefit with~     continuous popliteal catheters when compared to single injection techniques in regards to~     postoperative pain control and patient satisfaction for foot surgeries.~      Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial~     nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and~     does not involve the peroneal nerve. The purpose of this study is to compare the continuous~     posterior tibial nerve catheter with a single injection posterior tibial nerve block when~     used as part of a surgical ankle block for forefoot surgery.~   "
114671|NCT01555203|"~     The objective of this Phase II research is to evaluate the effectiveness of a~     population-based, individually tailored multiple health behavior change program for~     exercise, healthy eating, and stress management in a randomized trial including~     approximately 1,500 college students.~   "
114672|NCT01555190|"~     Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous~     ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our~     study is to investigate the role of folic acid conteined in the inositol preparation. The~     study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr)~     and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include~     menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance~     test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months~     of treatment.~   "
114673|NCT01555177|"~     Background~      It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of~     the coronary artery, resulting in blood clots which impede blood flow. Currently, the~     investigators do not know whether heart attacks in patients who had a recent surgery are~     caused by the same disease process as those who did not have any surgery. This study will~     inform the investigators of very vital information about the cause of surgery-related heart~     attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT).~     Images will also be taken from heart attack patients who did not have recent surgery, and~     the two groups will be compared.~      OCT imaging~      OCT is a relatively new imaging technology which is much better at taking images of the~     inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary~     angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary~     artery, it will record video images of a length of the artery. These images will take~     approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of~     the angiogram procedure is carried out in exactly the same way as it would normally proceed.~      The OCT study will provide doctors with new information about the cause of surgery-related~     heart attacks, and will guide doctors in treating and preventing heart attacks in patients~     who undergo surgery.~      Hypothesis~      The investigators hypothesize that features of acute plaque rupture will be more common in~     patients with non-surgery related heart attacks compared to those which occur following~     surgery.~      Design~      Two groups of patients will be recruited(>20 in each group):~        1. non-surgery related heart attack patients~        2. patients who suffered from a heart attack following an operation.~      Outcome measures~      Using OCT, plaque features in coronary arteries of patients with heart attacks from both the~     surgical and non-surgical groups at the time of coronary angiogram will be compared.~   "
114674|NCT01555164|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to~     determine the effect of ranolazine when added to metformin on glycemic control in adults~     with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current~     treatment with stable metformin therapy in addition to diet and exercise.~   "
114675|NCT01555151|"~     The purpose of this study is to compare the efficacy, safety and pharmacokinetics of~     Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and~     adolescent patients with persistent asthma.~   "
114676|NCT01555138|"~     The purpose of this study is to compare the effectiveness and safety of indacaterol with~     salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive~     pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone~     propionate.~   "
114677|NCT01555125|"~     The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI~     and IGA response rates versus placebo in subjects with moderate to severe chronic~     plaque-type psoriasis.~   "
114678|NCT01555112|"~     The purpose of this study is to determine whether the improved topical ointment formulation,~     AS101, is safe and effective in the treatment of external genital warts in females.~   "
114679|NCT01555099|"~     The purpose of the study is to assess the efficacy and safety of two staggered dose levels~     of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a~     background therapy of formoterol.~   "
114680|NCT01555086|"~     This study examines Limited versus extended pelvic lymphadenectomy.~   "
114681|NCT01555073|"~     Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being~     present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has~     been hysterectomy in post child bearing woman. However, over the last decade, the use of a~     minimal invasive technique called uterine artery embolization has become increasingly~     popular due to high patient satisfaction, cost effectiveness, and shorter recovery period.~     The purpose of this randomized blinded placebo controlled study is to compare pre-emptive~     analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term~     pain control, and improved quality of life in woman following uterine artery embolization~     surgery. The study consists of four drug groups including a placebo group. The addition of~     pregabalin and celecoxib together with epidural analgesia may improve pain management as~     well as leading to a better post-procedure outcome in women following uterine artery~     embolization.~      Many investigators believe that the ischemia in the normal myometrium is the primary source~     of pain immediately following surgery making postoperative pain management challenging.~     Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to~     being an effective analgesic for chronic pain syndromes, the use of pregabalin provides~     effective postoperative analgesia when it is administered pre-emptively before an operation.~     Preemptive analgesia involves the introduction of an analgesic regimen before the onset of~     noxious stimuli, with the goal of preventing sensitization of the nervous system to~     subsequent stimuli that could amplify pain. In human trials, pregabalin has been~     demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post~     herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide~     more effective analgesia by providing antihyperalgesia. Therefore, the addition of~     pregabalin and celecoxib together with epidural analgesia may improve pain management as~     well as having an effect on long term sequelae.~   "
114682|NCT01555060|"~     The purpose of this study is to investigate the effect of daily iron supplements after blood~     donation on time to recovery of hemoglobin and iron stores. The study will also determine~     whether the effect of iron supplements on time to recovery is different in men and women, in~     older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with~     replete vs. diminished pre-donation iron stores.~   "
114705|NCT01554761|"~     This study is to evaluate the necessity of considering posterior corneal toricity on~     refractive outcome of patients with cataracts and corneal astigmatism after implantation of~     intraocular lenses.~      This is determined by comparing total corneal and refractive astigmatism,and by comparing~     the expected refractive result with actual refractive astigmatism postoperatively,using~     total corneal and anterior corneal astigmatism to calculate respectively.~   "
114683|NCT01555047|"~     Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas~     (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra~     contaminating the semen during ejaculation. However, these microorganisms, especially~     Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species~     playing an etiologic role in both genital infections and male infertility. Despite there are~     many consentaneous opinions about its relationship with infertility, its correlation with~     sperm regular parameters is still controversially. Sperm DNA damage can negatively influence~     fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate,~     and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI~     pregnancy loss rate. Until now, there were fewer clinical researches about the relationship~     among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the~     investigators conduct this prospective study to investigate the relationship among them.~   "
114684|NCT01555034|"~     The Child health and Sports Center, Meir Medical Center, has an intervention program to~     treat obese children. The program includes physical activity, nutritional intervention and~     behavioral treatment.The emphasis given in the center to physical activity and sport enables~     a strong connection with movement therapy. Movement therapy allows obese children to face~     and cope with the psychological and emotional aspects of obesity.~      The purpose of this study is to evaluate the contribution of the movement therapy~     intervention to our program.~   "
114685|NCT01555021|"~     More than one out of three individuals treated for major depressive disorder (MDD) do not~     experience a full reduction of symptoms even when treated with adequate antidepressant~     medication. These individuals may have treatment-resistant depression. This is a condition~     that contributes to the tremendous costs of MDD, in terms of health care costs, functional~     impairment (limitation of an individual's functional ability), and diminished quality of~     life.~      There is a clear need for personalized medicine, for people at high risk for~     treatment-resistant depression. If these individuals could be identified early in the course~     of their depression, they could be recommended for more intensive or specialized~     interventions. Doing so could improve their likelihood of having a full reduction in their~     symptoms.~      Today, there are many treatment options for MDD. Individuals can spend months or years in~     and out of treatment before receiving one that works for their treatment-resistant~     depression.~      The investigators want to study treatment resistant depression by examining specific genes~     (genotyping) that might influence how your body responds to certain antidepressant~     medications. This process of examining specific genes is not experimental. To look at your~     specific genes, the investigators will collect a saliva sample. Genes contain the material~     passed from parent to child that determines the make-up of the body and mind. For example,~     some genes control the color of your hair or eyes. Genes are contained in your DNA~     (deoxyribonucleic acid). There are many differences in DNA, from one person to another.~     These differences may affect a person's chances of having a particular disease.~   "
114686|NCT01555008|"~     This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and tolerability of LX4211 following once daily oral administration in subjects with~     type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.~   "
114687|NCT01554995|"~     Primary~      - To investigate the safety and tolerability of LCB01-0371 after a single oral dose~      Secondary~        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral~          dose~        -  To investigate the safety of LCB01-0371 after a single oral dose~   "
114688|NCT01554982|"~     A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have~     completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may~     participate in this trial.~   "
114689|NCT01554969|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine,~     radiation, and the study drug kill cancer cells in different ways. Giving these treatments~     together may make your cancer shrink or slow down its growth more than it would if you got~     treated with capecitabine and radiation alone.~      This is a Phase I drug study of ganetespib given together with capecitabine and radiation in~     patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not~     approved by the Food and Drug Administration (FDA). The other two, capecitabine and~     radiation, are approved by FDA for use in rectal cancer.~      In this study, the investigators will test different dosages of the investigational~     (experimental) drug, called ganetespib (the study drug). The study drug is investigational~     because it is not approved by the FDA for use. The study drug has been previously tested in~     humans. The study uses a well-established process of slowly increasing drug dosage to~     determine the highest dosage that can be given without causing serious side effects. In~     addition, the study will help researchers to determine what the side effects and drug~     interactions might be.~      The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and~     capecitabine with radiation work in your body (for example how long the drugs last in your~     body.)~   "
114690|NCT01554956|"~     Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for~     topical ocular use will be evaluated for the indication of treatment of ligneous~     conjunctivitis.~      KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects~     with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All~     subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a~     possibility for extended treatment (Continuation segment)~   "
114706|NCT01554748|"~     The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal~     (TMC) joint by monitoring the survival of different implant types using radiostereometry~     (RSA) evaluation of the implants.~   "
114707|NCT01554735|"~     This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced~     by exercise and diet, improves metabolic and inflammatory profile, endothelial function,~     erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life~     in obese men.~   "
114708|NCT01554722|"~     Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal~     method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy~     and avoidance of needle-nerve contact has not been established. In this study the~     investigators tests the hypothesis that the incidence of needle-nerve contact is higher with~     the needle insertion in an out-of-plane than with the in-plane approach.~   "
114691|NCT01554943|"~     Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial~     involving node-positive early breast cancer patients with a long median follow-up (~ 15~     years)~      OBJECTIFS~      Primary:~      • To compare the incidence of late cardiac events between anthracycline and~     non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian~     three arm randomized clinical trial~      Secondary:~        -  To compare the late incidence of cardiac events between higher and lower dose~          anthracycline treated node-positive breast cancer patients;~        -  To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy~          for:~        -  left ventricular diastolic function assessed by Echo~        -  exercise capacity assessed by 6-minute walk test (6MWT)~        -  cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI~        -  serum cardiac biomarkers (BNP and TNT)~        -  patient-reported cardiac symptoms~        -  patient-reported cardiac symptoms assessed by QOL questionnaires are associated with~          subclinical findings on LVEF assessment~        -  cognitive function, functional autonomy, and psychological distress~   "
114692|NCT01554930|"~     The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a~     traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth~     disease (HFMD).~   "
114693|NCT01554917|"~     This study is intended to evaluate the safety and efficacy of Iguratimod in patients with~     active Rheumatoid Arthritis.~   "
114694|NCT01554904|"~     The study will test the hypothesis that training with the Facial-Flex exercise device for~     six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.~   "
114695|NCT01554891|"~     The current study will evaluate the initial reliability and validity of a new instrument,~     the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of~     Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)~     veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium~     investigators and designed to be given by a trained administrator. It allows for a~     determination of the level of evidence for exposure to a mild traumatic brain injury (TBI)~     using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The~     first objective is to determine the reliability (both test-retest and inter-rater) in a~     sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord and~     Fort Bragg (Cohort 1), who have screened positive for TBI on the Post-Deployment Health~     Assessment. The second objective is to determine the concordance between the SAFE-TBI and~     the VA TBI Screen in 100 OEF/OIF/OND veterans within the Northern New England VA Research~     Consortium (Cohort 2). The third objective, to be carried out in a sample of 200 Walter Reed~     National Military Medical Center (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND~     patients (Cohort 3), is to determine the sensitivity and specificity of the SAFE-TBI using~     the INTRuST study Brain Indices of Risk for Posttraumatic Stress Disorder after Mild~     Traumatic Brain Injury initial evaluation as the gold standard for TBI assessment.~   "
114696|NCT01554878|"~     The purpose of the study is to evaluate prospectively the outcome of treatment interventions~     of knee osteochondral lesions Outerbridge grade III and IV.~   "
114697|NCT01554865|"~     This study aims to compare the efficacy of a partial meal replacement diet with a~     conventional diet, for inducing weight loss and improving metabolic and inflammatory~     profile, endothelial function, erectile function, sexual desire, lower urinary tract~     symptoms (LUTS), and quality of life in obese men.~   "
114698|NCT01554852|"~     The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide,~     dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus~     lenalidomide with or without carfilzomib.~      Patients who do not have the best response to their initial treatment may then also be given~     a combination of cyclophosphamide, dexamethasone plus bortezomib.~      Patients who are relatively fit may, on their doctor's advice, go on to receive more~     intensive chemotherapy, supported with a transplant of their own blood cells. This is~     standard treatment which patients may be offered anyway even if they didn't take part in~     this study.~      After maximal response has been achieved with the treatment described above, and as long as~     the myeloma has not got worse, patients will be treated with either long-term lenalidomide,~     lenalidomide with vorinostat, or receive no further treatment, with close observation.~   "
114699|NCT01554839|"~     The purpose of this study is to evaluate the effectiveness of a unique web based educational~     tool called Family of Heroes, which is designed to educate families about Post Traumatic~     Stress Disorder (PTSD) and provide them with practical tools for interacting with affected~     veteran family members. The study includes veterans and a family member of their choosing.~     Participants are randomly assigned to a group which takes the online training or a group~     that does not take the training. Both groups complete a baseline questionnaire and a follow~     up questionaire 60 days later. The study will examine the number of Veteran Affairs (VA)~     mental health visits.~   "
114700|NCT01554826|"~     The clinical trial was designed to evaluate the immunogenicity and safety against pediatric~     Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on~     infants age 6 months to 36 months.~   "
114701|NCT01554813|"~     The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The~     purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's~     Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old~     population.~   "
114702|NCT01554800|"~     This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant~     human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery~     disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501.~     The dose will be escalated by cohort.~   "
114703|NCT01554787|"~     The high levels of fatigue in stroke patients without neurological impairment suggest it has~     a central origin rather than being the result of increased physical effort required after~     stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more~     serious stroke patients are more prone to fatigue（Windward et al., 2009）.~      Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most~     effective of all traditional Chinese medicine and can tonifying middle and tonify the~     original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus~     membranaceus on post-stroke fatigue.~   "
114711|NCT01554683|"~     The main purpose of this research project is to study how seizure-like activity affects the~     blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can~     change memory and thinking ability, as happens in Alzheimer's disease. The investigators are~     using a study drug called Levetiracetam, which helps control seizure-like activity to see if~     it can help change the abnormal blood flow in the brain that is seen in some people with~     Alzheimer's disease.~   "
114712|NCT01554670|"~     The purpose of this study is to determine whether radio-frequency (RF)-based plasma~     micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome~     with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that~     treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive~     either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic~     subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40).~     Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of~     motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of~     California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score~     were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and~     1-year.~   "
114713|NCT01554657|"~     The goal of the study is to determine if patients who are being treated for pneumonia in the~     intensive care unit can be safely treated with five days of antibiotics (the current~     standard is seven to eight days). The goal is to determine if the investigators can minimize~     antibiotic complications while still treating the infection. Patients in the study are~     randomly assigned to either receive antibiotics for a goal of five days or a goal of seven~     days. Every patient is followed daily, and if they are not responding to the antibiotics,~     the treating team in the intensive care unit care can continue the antibiotics for a longer~     course regardless of what group the patient is assigned. The investigator's hypothesis is~     that patients in the five day treatment goal will be able to receive less antibiotics than~     patients in the seven day treatment goal without any adverse effects.~   "
114714|NCT01554644|"~     This is a randomized controlled double blinded study involving two (2) investigational sites~     in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation~     Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This~     is a 12-week study.~   "
114715|NCT01554631|"~     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg~     taken without or with water and the Glucobay standard tablet 100 mg taken with water.~   "
114716|NCT01554618|"~     The study examines the Safety and efficacy study of exenatide once weekly in children and~     adolescents with type 2 diabetes.~   "
114717|NCT01554605|"~     The objective of this study is to investigate the role of gait disturbance as a cause for~     difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the~     following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments~     for Balance and Gait and Cognitive assessments.~   "
114718|NCT01554592|"~     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function~     as a pump to move blood around the body. This sets up a complex physiologic response to~     compensate, which include activation of many hormonal mechanisms which result in fluid~     accumulation.~      In recent years, medications to block the hormonal response to heart failure are given as~     standard drugs, and these include ACE inhibitors and beta blockers. Mortality is reduced~     with these medications, as well as symptoms improved. Other medications are also used in~     heart failure, for which a clear-cut benefit has not been demonstrated. Statins, also called~     HMG CoA reductase inhibitors, are used to reduce cholesterol levels and can help to prevent~     heart failure by preventing heart attacks. They have been used in heart failure that is not~     caused by heart attacks in the belief that they had pleiotropic effects, meaning that they~     had beneficial effects in heart failure separate from the reduction in cholesterol.~      However large trials in heart failure have demonstrated that statins do not increase~     survival compared with placebo. There is no evidence to recommend their routine use in~     established heart failure caused by either heart attacks or genetics.~      The investigators propose that the use of statins in heart failure is unnecessary and could~     be stopped. The importance of finding evidence to cease unproven medications in heart~     failure cannot be understated. Patients with heart failure take an average of six~     prescription medications each day. Each medication has side effects and the interactions of~     all the drugs together are unknown. Statins are the commonest reason for side effects in~     patients with heart failure, causing muscle pains and gastrointestinal upset.~      In this study, the investigators plan to withdraw statins from patients with stable heart~     failure in a closely monitored environment and watch for the effect of this on heart failure~     and on how they feel generally.~   "
114719|NCT01554579|"~     The purpose of this study is to assess the efficacy of a single dose level of AF-219 in~     subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee~     compared with placebo after 4 weeks of treatment.~      The study will also assess the safety and tolerability, changes in physical function,~     stiffness, global assessment of OA, treatment response and health outcomes.~   "
114720|NCT01554566|"~     This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in~     patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks~     intervention periods) was used to measure honey effects. The subjects were randomized into~     two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each~     group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day~     in the first 12-week period (period 1) while the subjects in the C/I group did not receive~     honey as a control in period 1. After period 1 the subjects of each group exchanged their~     protocol for the following 12-week period (period 2).~   "
114721|NCT01554553|"~     The purpose of this study is to evaluate the superiority of posterior crural repair during~     sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical~     reflux disease.~   "
114722|NCT01554540|"~     The purpose of the study is to assess skin blood flow after non-invasive local~     administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the~     forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The~     investigators also aim at assessing the systemic bioavailability and dermal diffusion of~     treprostinil iontophoresis.~   "
114723|NCT01554527|"~     Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to~     problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood.~     Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now~     performed more often for suspected SDB than for any other indication. However, recent~     studies indicate that many if not most children still have SDB after AT, and many still have~     learning or behavioral problems associated with SDB. The goals of this study are: (1) to~     assess the extent that behavior, cognition, and sleepiness in children can improve with~     Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which~     patients stand to gain most from post-operative assessment and treatment.~   "
114724|NCT01554514|"~     Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots~     throughout the body that can damage major organs and cause death. TTP is treated with plasma~     exchange (also called plasmapheresis). Patients who do not respond initially to plasma~     exchange often are helped by later treatment with rituximab. The purpose of this study is to~     see whether combining low doses of rituximab with plasma exchange will help patients get~     better sooner and reduce the chance of getting TTP again.~   "
114725|NCT01554501|"~     The purpose of this study is to examine the effects of stress on mental and physical health~     and behavior.~   "
114726|NCT01554488|"~     The Chairman of the Veterans' Disability Benefits Commission reported at a recent US Senate~     hearing that asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea are among~     the top 13 most frequent diagnoses leading to disability under the Department of Defense and~     the VA system statutes. Recent research finds that sleep apnea is more common among asthma~     and COPD individuals, and this may be caused by inhaled corticosteroid use. Many Veterans~     are currently using inhaled corticosteroids, and many more will be prescribed such~     medications, given their recent inclusion in international treatment guidelines. As such,~     this study addresses a critical need by researching the role of a potent inhaled~     corticosteroid in promoting sleep apnea, the determinants of this response, and the ways~     through which it occurs. Results from this study will form the foundation for future~     research aimed at expanding understanding of the effects of inhaled corticosteroids on the~     upper airway, as well as developing means to prevent or counteract them.~   "
114727|NCT01554475|"~     So far, no drugs have shown to stop or delay the pathological processes of dementia.~     Available pharmacological treatment includes a small number of drugs; cholinesterase~     inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist~     memantine, all of which only affect the symptoms of the disease. At the same time,~     alternative medicines like herbal products and dietary supplements are often intensively~     marketed with the assertion of curative or alleviating effects on dementia. The~     documentation of clinical effects, side effects and the potential for interaction with~     prescribed drugs are, however, generally scarce. The aims of this study are to make a survey~     of the use of alternative medicine in patients with dementia and mild cognitive dysfunction~     attending the investigators out-patient dementia clinic, and to assess the interaction~     potential with the patient's other medications.~   "
114728|NCT01554462|"~     Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD)~     receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary~     intervention. Cognitive control functions are measured with functional Magnetic Resonance~     Imaging (MRI) before and after the intervention. Behavioural change is monitored with~     behavioural scales.~   "
114729|NCT01554449|"~     The purpose of this study is to assess the efficiency of occupational therapy enhanced by~     dedicated adaptative video games in rehabilitation of the upper arm of stroke patients in~     the acute phase after their cerebro-vascular accident. Our hypothesis is that occupational~     therapy enhanced by dedicated adaptative video games is more efficient in improving motor~     recovery of the upper arm than conventional occupational therapy alone.~   "
114730|NCT01554436|"~     The low overall effectiveness of available smoking cessation treatment so far, indicate the~     need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a~     highly heterogeneous population. Identification of individual characteristics that predict~     success in smoking cessation is highly desirable to allow designing more specific strategies~     in order to enhance success in quitting tobacco.The main objective of this study is to~     assess whether the presence of certain neuropsychological deficits found before the~     initiation of smoking cessation is associated with a greater relapse rate.The secondary~     objectives concern how neuropsychological performance are involved in motivation and craving~     in the whole sample of smokers or in subsample. Long-term perspective is to define clinical~     or neuropsychological factors associated with agood or poor prognosis for success and~     provived more specific and therefore more effective care.~   "
114731|NCT01554423|"~     This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral~     Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of~     a brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT)~     intervention alone and in combination against a comparison condition to reduce new cases of~     HIV and sexually transmitted infections and increase condom use and decrease sexual risk~     behavior, drug use, and intimate partner violence among young female drug users in Pretoria,~     South Africa and their primary intimate partners. In the RCT, 384 couples comprised of young~     female drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate~     heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and~     counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples'~     intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples~     include an HIV-negative drug using female aged 18 to 40 and their primary intimate partner~     or spouse who is also HIV negative. Each partner of each couple will be administered~     assessments with a rapid test for HIV and urine tests for Chlamydia, gonorrhea,~     trichomoniasis, and drug use at baseline and 3-month, 6-month, and 12-month follow-up.~   "
114732|NCT01554410|"~     The primary objective of the study is to identify the highest dose of gemcitabine that can~     be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in~     women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will~     reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine~     to be feasibly delivered in patients with locally advanced cervical cancer.~   "
114733|NCT01554397|"~     The purpose of this study is to find out whether patients with cervical cancer treated with~     IMRT have less side effects with equal cancer control compared to standard radiation~     techniques. With standard radiation techniques, normal pelvic organs near the tumor receive~     radiation dose, which leads to side effects. IMRT is a new radiation technique that can~     reduce radiation dose to these organs and may reduce side effects.~      Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute~     hematologic and gastrointestinal toxicity for cervical cancer patients treated with~     concurrent cisplatin.~   "
115456|NCT01545050|"~     The purpose of this study is to characterize the safety, efficacy and dose response of~     BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an~     insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor~     (anti-TNF) therapy.~   "
114734|NCT01554384|"~     Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can~     detect TB genetic material in sputum samples as well as test for genetic resistance to~     rifampicin providing results within 2 hours. Xpert received WHO endorsement in December~     2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related~     patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at~     the point-of-treatment (POT) i.e. in primary care clinic location. The investigators~     hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve~     time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with~     suspected TB presenting to primary level TB clinics in high HIV prevalent settings.~   "
114735|NCT01554371|"~     The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide~     (Cytoxan®) given together at different doses. This study will look at what effects, good~     and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved~     by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide~     has been approved for different types of cancers (including breast cancer). However, the~     combination of eribulin and cyclophosphamide is considered experimental; that means this~     combination has not been approved by the FDA.~      The funding for this study is provided by Eisai Inc., the maker of eribulin.~   "
114736|NCT01554358|"~     A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009~     have and continues to be randomly assigned to either the intervention group or the control~     group. GDM women in the intervention group will have five consulting sessions with a~     dietician during the first year and two sessions during the second year. The intervention~     group are given detailed advice about how to achieve the six goals of the intervention. The~     primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes~     (T2D) in women with prior GDM. The second aim will test gene-intervention interactions~     through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation~     to metabolic traits for T2D in GDM women.~   "
114737|NCT01554345|"~     The purpose of this study is to determine whether Kidney injury happens in controlled~     hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin~     ELISA Kit and if so, does VitaminE+Selenium prevent it~   "
114738|NCT01554332|"~     The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an~     adjunctive treatment for chronic neuropathic pain.~   "
114739|NCT01554319|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need~     for novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product~     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA~     (deoxyribonucleic acid)zymes (antisense oligonucleotide). DNAzymes are catalytically active~     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3~     mRNA, hgd40 reduces specific cytokine production and thereby reduces key features of~     allergic airway inflammation.~      DNAzymes are generated completely by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or~     bacteria. The molecules are highly water-soluble and will be applied as solution directly in~     their synthesized form.~      The current study will evaluate the safety and tolerability of increasing multiple doses of~     inhaled SB010 in healthy male subjects.~   "
114740|NCT01554306|"~     Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor~     symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can~     also be present during the night. Half of the patients with PD have difficulty turning~     around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep~     problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical~     interview. There is a need for a diagnostic devices that measures nocturnal movements,~     preferably in the home setting. This device can be used in the diagnostic trajectory as well~     in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has~     been developed to register nocturnal movements. The tri-axial accelerometer has been~     developed to measure position changes in the night. A validation study with actigraphy and~     polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for~     assessing intensity and physical activity and changes of body position during sleep.~      Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of~     dopaminergics is adequate, but most of the time slow release dopaminergics are needed.~     However response fluctuations can negatively influence the treatment. In these cases~     continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats~     response fluctuations during the day and studies show that sleep quality measured with~     questionnaires improves. If the improvement of sleep quality is caused by improved bed~     mobility has not been studied yet. The study hypothesis is that rotigotine does not~     influence nocturnal hypokinesia in PD.~      Objective of the study:~      Primary:~      • To study the effect of rotigotine on nocturnal hypokinesia~      Secondary:~        -  To study the possibility of measuring nocturnal hypokinesia and its severity in a home~          setting~        -  To correlate improvements in sleep quality by rotigotine with changes in nocturnal~          hypokinesia~      Study design:~      We will study patients who will recieve rotigotine as a part of their usual care. During~     three nights, nocturnal movements are being registered with movement sensors, before~     treatment has started as well as after a stable medication dose of one month. We will also~     assess sleep quality with questionnaires.~      Study population:~      The study population are patients with Parkinson's disease with sleep problems caused by~     nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited~     in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen.~     We will ask the treating neurologist to inform us when a patient will start treatment with~     rotigotine. One of the researchers will contact the patient to give further information~     about the study. The study is a first hypothesis generating study and we will start with the~     inclusion of 10 patients.~      Intervention (if applicable):~      Primary study parameters/outcome of the study:~      Position changes over the night.~      Secundary study parameters/outcome of the study (if applicable):~      Objective~        -  Degree of mobility, measured as the speed of the movements~        -  Total amount of movements~        -  Score on the motor symptom scale according to the MDS-UPDRS part III~      Subjective~        -  Nocturnal sleep quality Excessive daytime sleepiness~        -  Presence of nocturnal akinesia~   "
114741|NCT01554293|"~     PBL 1427 is a Dipeptidyl peptidase (DPP)-IV inhibitor being developed for treatment of type~     2 diabetes. Although a number of DPP-IV inhibitors have been described, there still exists a~     need for new DPP-IV inhibitors that have better half-life, advantageous potency, stability~     and selectivity, less toxicity and/or better pharmacodynamic properties.~   "
114742|NCT01554280|"~     The purpose of this study is to investigate whether preventative placement of a removable~     oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the~     precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The~     stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks~     later by repeat Endoscopy. Patients will be followed up weekly following insertion of the~     oesophageal stent.~   "
114783|NCT01553734|"~     The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with~     life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new~     macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is~     that patients hospitalized with severe community acquired pneumonia, usually with multiple~     comorbid conditions will have a higher rate of QT prolongation, compared to the clinical~     trials published~   "
114743|NCT01554267|"~     In the investigators previous study of 51 breast reconstructions (32 patients), we compared~     three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein~     dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because~     tissue with poor perfusion becomes necrotic and can compromise the success of breast~     reconstruction, it is important that tissue with poor perfusion be removed at the time of~     the reconstructive surgery. However, it is also important to remove the least amount of~     potentially necrotic tissue as possible so that the breast reconstruction is not compromised~     by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a~     vital clinical question. In the initial study the 3 different assessment methods which were~     made at the time of surgery were compared to the subsequent development of necrotic tissue.~      In the initial study, clinical judgment was the basis for determining the tissue removed~     because it had the potential to become necrotic. The investigators collected data with the~     FDA system and ICG system, but this data was not used in making the clinical decisions. The~     study followed the progression of tissue to overt necrosis and this clinical outcome was~     then compared to the predictions made by the three different assessment strategies. The~     investigators found that clinical judgment failed to detect tissue which subsequently became~     necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted~     larger areas of potentially necrotic tissue than clinical judgment, but was found to~     over-predict the area that became necrotic by 82% - 88% (88% if all cases were included and~     82% if only those cases which subsequently developed necrosis were included). Although the~     ICG system is similar to the FDA system in that a dye is used to assess perfusion, the ICG~     system has enhanced software which improves the estimated perfusion. The ICG system provided~     90% sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific~     absolute perfusion units values.~      Hypothesis: Using the values of absolute perfusion units discovered in the previous study~     and implementing its use in the operating room will decrease all-inclusive necrosis rates to~     below 10%, reflecting a 31% decrease in the investigators necrosis rate.~   "
114744|NCT01554254|"~     Engraftment failure is a major obstacle to the success of cord blood transplantation in~     children with malignancies and inherited metabolic disorders, despite the fact that they~     receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically~     formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (which~     contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127~     has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data~     show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors,~     increases engraftment of committed hematopoietic progenitors, and induces more rapid~     production of platelets and neutrophils in the peripheral circulation, especially in limited~     cell number transplants. Treatment with TXA127 following UCBT is expected to increase the~     numbers of hematopoietic progenitors and accelerate engraftment.~   "
114745|NCT01554241|"~     Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D~     supplementation. The limited data available show marked inter-individual variability in~     response to vitamin D supplementation in very old, frail elderly with almost 25% remaining~     vitamin D deficient (25-OH D < 20 ng/mL) when receiving the currently recommended 800 IU/day~     vitamin D. This proposal is for exploratory research on the use of a wide range of oral~     vitamin D3 doses in frail elderly living in controlled living environments.~   "
114746|NCT01554228|"~     Bariatric surgery provides a strong and long-term effect in reducing weight in obese~     subjects. Studies showed that obesity and its comorbidities are associated with a lower~     cognitive performance. The aim of the researchers study is to examine the cognitive~     performance of the patients before and after bariatric surgery.~   "
114747|NCT01554215|"~     Mom Power is a weekly attachment based parenting program aimed to increase parenting and~     self-care skills for families.~   "
114748|NCT01554202|"~     According to estimations, Alzheimer's disease affects approximately 860,000 people aged of~     more than 65 years in France. This disease is characterized by disorders of cognitive~     functions, including memory, associated with structural and functional modifications of the~     brain. These changes are evolving within the pathology progression and can be evaluated with~     neuropsychological tests (to assess capabilities such as language, orientation, etc.) and~     also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood,~     nevertheless currently available treatments can slow its development if the disease is~     diagnosed early enough.~      Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to~     better describe the evolution of this disease.~      The three main objectives of this project are~        -  to identify, compare and combine predictive markers of Alzheimer's disease~        -  to make a significant contribution to the understanding of the pathophysiological~          mechanisms of Alzheimer's disease~        -  to study the ability of different neuroimaging techniques to follow the evolution of~          this pathology.~   "
114749|NCT01554189|"~     This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics~     (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts~     to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll~     only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a~     HCV-infected participants. All parts may run concurrently, or may be staggered as needed by~     the clinical sites.~   "
114750|NCT01554176|"~     The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096)~     versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants~     who are partial responders to antidepressant monotherapy with one of identified selective~     serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors~     (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to~     placebo as augmentation therapy with respect to change from baseline to Week 6 in the~     Montgomery Asberg Depression Rating Scale (MADRS) total score.~   "
114751|NCT01554163|"~     The main purpose of this study is to establish that etoricoxib 30 mg is safe and not~     inferior to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in~     Korean patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of~     osteoarthritis has been established, and that prescription drugs, such as celecoxib, are~     available for the treatment of pain associated with osteoarthritis in Korea, it would be~     inappropriate to subject patients with a flare of osteoarthritic pain to the placebo~     treatment for 12 weeks, and thus the study is designed as an active-comparator study.~   "
114752|NCT01554150|"~     The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an~     effective intervention for treating clients with a range of presenting problems in primary~     care by comparing it with a waiting list control condition.~   "
114779|NCT01553786|"~     This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by~     complete response rate at the end of treatment. Approximately 80 patients aged between 60~     and 80 years will be included, to have 70 evaluable patients. The treatment consists of two~     phases of four 3-weeks cycles: induction phase and consolidation phase, for a total~     treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will~     be administered in the hospital on day 1, prednisone is continued for 5 days and~     lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after~     inclusion of the last patient.~   "
114753|NCT01554137|"~     Stroke (CVA) is the leading cause of death and the leading cause of disability in developed~     countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients~     keep a permanent disability in 75% of cases and only one quarter of them is able to resume~     work. The post stroke sequelae are sensory-motor and cognitive.~      According to literature data, 75-83% of patients who survive a stroke learn to walk only 25~     to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).~      The existence of a phase called plateau in motor recovery after stroke has been suggested~     (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase~     where the rehabilitation techniques used in the subacute phase are deemed less effective.~     Recently, Page (2004) speculated that this plateau phase is rather the consequence of~     adaptation to the type of patient follow-up training and not that of a limit to the~     possibilities of recovery. In an observational study on the recovery of upper limb conducted~     over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post~     stroke. The results of studies on different techniques for rehabilitation of chronic stroke~     patients tend to confirm the hypothesis of page. Therefore, varying the training parameters~     (type, intensity, frequency) could improve the functional capabilities of these patients,~     even at a distance of stroke.~      Strength training is part of the management of hemiparetic patients. The results of several~     studies show an improvement in muscle strength and functional ability to walk after a~     building program isokinetic lower limb (Sharp, 1997).~      The objective of our project is to evaluate the effectiveness of a building program of~     isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months~     of a stroke.~   "
114754|NCT01554124|"~     This phase I-II multicenter international trial is designed to study the pharmacokinetics of~     meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤~     90 days of postnatal age with probable or confirmed bacterial meningitis.~   "
114755|NCT01554111|"~     Objective and Hypothesis:~      The investigators objective is to help determine the efficacy of oral and rectal bowel~     preparation regimens for sigmoidoscopy. The investigators hypothesis is that oral~     preparation will reduce the amount of repeat rectal enemas required and improve the quality~     of a bowel exam at the sigmoidoscopy.~   "
114756|NCT01554098|"~     This study will compare two strategies for colonoscope withdrawal, using polyp detection as~     the primary outcome measure, to determine the optimal withdrawal strategy.~      Null Hypothesis:~      On withdrawal of the colonoscope, examining patients with dynamic position change does not~     yield more polyps than the supine position.~      Alternative Hypothesis:~      On withdrawal of the colonoscope, examining the patients with dynamic position change~     improves polyp detection compared to the supine position.~   "
114757|NCT01554085|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers~     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.~      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will~     assess food effects on pharmacokinetics in HV.~      Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with~     CHC genotype 1 infection.~   "
114758|NCT01554072|"~     Pulmonary rehabilitation consists of a multidisciplinary program of care for patients with~     chronic respiratory disease, which currently encompasses numerous features and physical~     training methods aimed at maintaining stability clinic for people with Chronic Obstructive~     Pulmonary Disease (COPD), especially in patients who, even with optimized clinical~     treatment, continue their decline and symptomatic physical functions and 8 so that these~     social. goals are achieved the patient with COPD should integrate into a program of RP~     assiduous and with accompanying several times per week, for several months, which for a~     number of factors is not always possible. For this reason, it is the research of methodology~     of RP that hold their effectiveness, but with greater flexibility and viability to people~     with COPD. On this basis, this study aims to investigate the effectiveness of a program of~     RP semi-domiciliar in which the patient suffering from COPD can receive guidance and~     training in person, to develop it partially in own domicile.~   "
114759|NCT01554059|"~     The purpose of the study is to evaluate the efficacy and safety of the combination of~     cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with~     radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable~     rectal adenocarcinoma.~   "
114760|NCT01554046|"~     The purpose of this study is to investigate the familial response to Methylphenidate~     treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects~     development.~   "
114761|NCT01554033|"~     REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's~     disease (HD) with a control group of volunteers. It is an open-ended study which will~     include as many eligible participants as willing to participate. The goal of the project is~     to collect longitudinal data on the phenotypical characteristics of HD gene mutation~     carriers regardless of whether they display clinical symptoms and signs of the disease and~     of individuals who are part of an HD family (irrespective of their mutation carrier status),~     in order to:~        -  obtain natural history data on a wide spectrum of HD mutation carriers and individuals~          who are part of an HD family~        -  relate phenotypical characteristics~             -  with genetic factors ('genetic modifiers')~             -  with data derived from the study of body fluids (blood, urine - 'wet biomarker')~               and~             -  imaging data ('dry biomarker')~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of premanifest and manifest HD which may also be~          potential outcome measures for use in future clinical trials and clinical care.~        -  plan for future research studies (observational and interventional trials aimed at~          better symptom control or aimed at slowing or postponing the onset and progression of~          HD).~   "
114762|NCT01554020|"~     This prospective international clinical trial is a two-arm, double-blind, randomized,~     placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be~     randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender.~     The intervention period is 12 weeks. The primary outcome is fasting glucose levels.~   "
114780|NCT01553773|"~     The aim of this trial was to compare the effects of estradiol or genistein treatment on the~     hialuronic acid concentration on the postmenopausal facial skin. In this study, 30~     postmenopausal women were evaluated through a prospective, randomized, double-blind trial.~     The volunteers were postmenopausal women treated in the Gynecology Department of the Federal~     University of São Paulo (UNIFESP). The participants were divided into two groups: group E,~     treated with 17 β estradiol gel 0.01% (n = 15), and group G, treated with genistein gel 4 %~     (isoflavones, n=15). The length of treatment was 24 consecutive weeks. Preauricular skin~     biopsies were performed on each patient before and after the treatment for evaluating~     hyaluronic acid in the tissue. The materials were processed through immunohistochemical and~     biochemical methods.~   "
114763|NCT01554007|"~     In the past decade, the incidence and prevalence of CD (Crohn's disease) has continued to~     increase in Korea. Previous studies have indicated that Asian IBD (inflammatory bowel~     disease) patients differ from those of Western patients with regard to the genetic~     susceptibility and some clinical features. However, the available published data from~     retrospective studies in Korea were largely incomplete. The investigators aim of the study~     is a set-up of Korean cohort for CD, and thereby to assess the clinical course of Korean CD~     patients through a prospective multicenter long-term follow-up study. Secondary aims of this~     study are as follows: (1) to evaluate the efficacy, tolerability, and predictors to response~     to anti-TNF therapy for CD, (2) to identify the risk factors for postoperative recurrence on~     the basis of information obtained at initial diagnosis, and (3) to evaluate~     genotype-phenotype correlation.~   "
114764|NCT01553994|"~     Overview and rationale: Through Swedish health care registers it is possible vaccine~     effectiveness. The overall aim is to develop tools for fast and reliable evaluation of~     vaccines focusing on effectiveness. In this study the investigators will assess the~     population impact on condyloma prescribed drugs after HPV-vaccination and to estimate the~     economic burden of hospitalizations due to condyloma. Genital warts (condyloma) are one of~     the most common sexually transmitted diseases in Sweden, estimated 20 000 identified cases~     per year, and are primarily treated with Podofyllotoxin and Immiquimod. One of the approved~     HPV vaccines also protects against condyloma. In clinical trials, this vaccine is safe and~     highly efficacious (90-100%) against persistent infection with HPV 6 and 11 and genital~     warts in women and men. However, these results are from clinical trials and do not answer~     the question weather the vaccine works when delivered, as it would be in the real world. By~     linkage between the Svevac, the patient register and the Drug prescription register the~     investigators can estimate the effectiveness of the HPV vaccine in preventing cases of~     condyloma in a defined population.~      Method and execution: This is a retrospective collection of data from Swedish health care~     registries where the study population will consist of persons who are HPV-vaccinated as well~     as a non-HPV-vaccinated control group (identified through the population-based register,~     matched on sex, age and living area). The primary statistical analysis will be a calculation~     of prescriptions of condyloma treatments after vaccination compared to the non-vaccinated~     control group.~   "
114765|NCT01553981|"~     Systemic sclerosis (SSc, scleroderma) is a multisystem autoimmune rheumatic disease that~     causes inﬂammation, vascular damage and ﬁbrosis. Besides involvement of skin, fibrosis also~     affects lung and heart. Although advances in understanding in pathophysiology and use of~     immunosuppressive therapy has brought significant improvement in outcome of other autoimmune~     diseases, scleroderma still remains as a disease with high mortality and 10 yr survival rate~     has improved only from 54% to 66% during last 25 years1. The frequency of deaths due to~     renal crisis significantly decreased (mainly due to effectiveness of ACE Inhibitors), from~     42% to 6% of scleroderma-related deaths (p 0.001), whereas the proportion of patients with~     scleroderma who died of pulmonary fibrosis increased (due to lack of significant treatment)~     from 6% to 33% (p 0.001). However, presently, trials with immunosuppressive drugs including~     cyclophosphamide and other targeted molecules like Bosentan and Imatinib mesylate have shown~     very modest results at the best and given the risk of toxicity. The investigators have~     conducted three clinical trials with PDE5 inhibitor Tadalafil in the refractory Raynaud's~     phenomenon (RP) in SSc over last 3 years and had found good response in RP, healing of~     digital ulcers, prevention of new digital ulcers and also observed improvement in skin~     tightening, endothelial dysfunction and improvement of quality of life. The investigators~     therefore hypothesize that tadalafil may have an efficacy in improving the ILD of SSc.~      The investigators therefore design this double-blind, randomized, placebo-controlled trial~     of oral Tadalafil (20 mg alternate day) in patients with SSc having ILD. Patients will be~     randomly assigned in a 1:1 ratio to receive either Tadalafil or matched placebo and will be~     followed up for 6 months. Prednisolone (if required for indications other than ILD) will be~     allowed up to 10 mg/d in all patients. Patient/s requiring more than 10 mg/d of prednisolone~     or equivalent dose of steroid will be excluded from the study. Patients who will fail on~     therapy during the study will be excluded from the study and will be asked to choose any~     therapeutic option from the rescue protocol.~      Patients with FVC ≤ 70% predicted or DLCO ≤ 70 % of predicted, Evidence of ILD on HRCT will~     be enrolled. The primary objective of the study will be the change in FVC (expressed as a~     percentage of the predicted value) from baseline values at the end of 6-months of treatment.~     The secondary objectives will be improvement in dyspnea, improvement in 6 min walk distance,~     change in DLCO, change in total lung capacity, change in the disability index of the Health~     Assessment Questionnaire (S HAQ), and change quality of life (SF-36), levels of NT pro-BNP~     and fibrosis markers.~   "
114766|NCT01553968|"~     It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie~     insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus.~     Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected~     that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will~     accumulate, because of an improved balance between supply and demand of lipids.~      The major research objective is to examine if acute exercise results in a more pronounced~     increase in acetylcarnitine concentration in sedentary subjects compared to~     endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is~     restored more quickly in endurance-trained subjects when compared to sedentary subjects.~      The investigators hypothesize that the increase in acetylcarnitine levels will be lower in~     trained subjects when compared to sedentary subjects, due to a better balance between lipid~     supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine~     concentrations will be restored faster in these trained subjects, because of a tighter~     regulation of influx of fatty acids.~      To test this hypothesis the investigators want to compare the acetylcarnitine response to~     exercise in a group of sedentary subjects and a group of endurance trained subjects. This~     response will be measured for 30 minutes after exercise with the use of 1H-MRS.~   "
114767|NCT01553955|"~     This is a device study in some respects, in that specialized centrifuges are commonly used~     to make platelet rich plasma, and we are studying the use of standard laboratory equipment~     to do so. However, it is primarily interventional in that we will evaluate the percentage~     success of trainees in the concentration of viable platelets to more than 4X baseline using~     a generic speed centrifuge and a single spin method.~   "
114781|NCT01553760|"~     The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as~     the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm~     corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm~     corneal incision).~   "
114782|NCT01553747|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     different doses of JNJ-27018966 compared with placebo in the treatment of patients with~     diarrhea-predominant irritable bowel syndrome.~   "
114784|NCT01553721|"~     This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy~     and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).~   "
115457|NCT01545037|"~     The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms~     of IBS.~   "
114768|NCT01553942|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that study~     doctors are trying to find out more about it-such as the safest dose to use, the side~     effects it may cause, and if the drug is effective for treating different types of cancer.~     It also means that the FDA has not yet approved the drug for the patients type of cancer or~     for any use outside of research studies.~      Chemotherapy and radiation is the standard treatment for the patients with stage III~     non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR)~     mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase~     the response to treatment.~      Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in~     participants with more advanced NSCLC. Results from that study indicate it may be helpful in~     treating NSCLC with EGFR mutations.~      In this study, patients with stage III NSCLC and EGFR mutations will receive the standard~     treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by~     surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim~     of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the~     radiation therapy more effective since radiation therapy tends to work better on smaller~     tumors.~      The goal of this study is to see if adding afatinib to standard treatment helps to improve~     the response to treatment.~   "
114769|NCT01553929|"~     Regular physical activity is now recognized as a key element of good physical and mental~     health and this all ages.~      MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive~     training in improving the cognitive function of patients diagnosed with Mild Cognitive~     Impairment (MCI).~      DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for~     the patient with three groups : one physical training and cognitive exercise group, one~     physical training without cognitive exercise group and one control group.~      In agreement with the literature on the effects of physiological stress on cognitive~     performance, the investigators expect the best cognitive test scores in groups with exercise~     training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD,~     depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.~     Furthermore the investigators hypothesize that this positive effect is greater in the~     physical training and cognitive exercise group compared with the physical training group~     only.~   "
114770|NCT01553916|"~     This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium)~     to patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain~     (PCI; prophylactic cranial irradiation). PCI is used to prevent cancer metastases from~     returning in the brain. This treatment can cause short-term memory problems by damaging the~     hippocampus. Lithium may help prevent or lessen memory problems caused by PCI by protecting~     the hippocampus.~   "
114771|NCT01553903|"~     This is a biomedical study of interventional type which includes 29 patients on 9 months: 8~     months recruiting and 1 month follow up.~      Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an~     indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained,~     will be enrolled in this study.~      The main objective of this study is to evaluate the feasibility for the determination of~     Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of~     treatment (ie, at D0 before and D28 after beginning of treatment).~   "
114772|NCT01553890|"~     The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and~     compare with control. A second goal is anti vitamin D levels in serum of scleroderma~     patients in relation to the clinical manifestations of the disease.~   "
114773|NCT01553877|"~     The prevention of malnutrition among children under 5 years of age requires consumption of~     nutritious food, including exclusive breast feeding for the first six months of life,~     followed by breastfeeding in combination with complementary foods thereafter until at least~     24 months of age; a hygienic environment; access to preventive as well as curative health~     services, and good prenatal care. The proposed research is on the possible options for~     providing a nutritious diet, realizing the constraints of poverty and food insecurity faced~     by care givers whose children are at risk of developing or confirmed to be suffering from~     moderate malnutrition. Even when people are not typically food insecure but consume a~     relatively monotonous diet with few good-quality foods, they also have to have options for~     dietary improvement, and especially the possibility of ready-to-use complementary food~     supplements (RUCFS) for young children. This proposed research on development of RUCFS will~     pave the way for programmatic considerations for expansion of the use of new complementary~     food supplements for preventing malnutrition among young children in Bangladesh.~   "
114774|NCT01553851|"~     This phase II trial studies how trametinib effects tumor cells in patients with oral cavity~     squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by~     blocking an enzyme pathway needed for cell growth.~   "
114775|NCT01553838|"~     The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher~     prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy~     in patients with increased PSA values > 4.0 ng/ml.~   "
114776|NCT01553825|"~     Assessing the mindset of cancer patients will help us better understand which patients are~     having difficulty dealing with the diagnosis and treatment that may not otherwise be fully~     appreciated by their physicians. By identifying such patients, we may then be able to design~     and implement strategies that can help improve their coping skills both during the treatment~     as well as after the completion of treatment. In addition to addressing physical concerns~     and symptoms, this approach will help address the overall emotional impact of a cancer~     diagnosis as more patients are living as cancer survivors.~   "
114777|NCT01553812|"~     The study hypothesize that parameters of new function machine---'forced oscillation~     technique' (FOT) can correlate well with the conventional lung function data for measurement~     of airway resistance and airtrapping in elderly COPD patients.~   "
114778|NCT01553799|"~     tracheal and endobronchial misplaced will be checked quickly qith US~   "
114832|NCT01553097|"~     This longitudinal project will investigate a common complaint of women who receive~     chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress,~     and depression to cognitive difficulties will be examined. The findings should lead to~     interventions to decrease the effects of these problematic side effects.~   "
114785|NCT01553708|"~     Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism~     of epithelialization. However, it depends on the depth of the wounds and patient condition.~     Infection is one of the most common complications causing delay in wound healing which might~     affect to quality of patient's life. Generally, the standard treatment of partial thickness~     burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the~     broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not~     demonstrate the accelerating effect of wound healing. Therefore, the combination of~     substance which can promote wound healing to topical silver sulfadiazine cream might benefit~     for partial thickness burn wound treatment.~      The objective of this study was to compare the results of partial thickness burn wound~     treatment at burn unit, Siriraj hospital with topical cream containing 1% silver~     sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The~     demographic data (age, sex, %body surface area burn), time of wound closure, pain and~     itching, dose and type of pain and itching medication, adverse effect of topical medication,~     some laboratory results and cost of expenses.~      This is the prospective, double blinded, randomize-controlled study. The sample sizes were~     partial thickness burn wound patients who were treated at burn unit, Siriraj hospital.~     Patients were allocated into 2 groups receiving treatment with either topical silver~     sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with~     repeated measure ANOVA and independent t-test.~   "
114786|NCT01553695|"~     ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5%~     of adults worldwide. This condition is under-recognised in France and other European~     countries and, therefore, under-diagnosed.~      As part of the European Network for Adult ADHD, the investigators translated into French a~     structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators~     also translated rating scales such as the ASRS and the WURS. Validation studies are rare in~     France.~      The aim of this study is to include two groups of 50 adults whether they have or not ADHD~     with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as~     implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to~     fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale~     (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a~     screening tool for ADHD in childhood with respect of the Utah criteria). The investigator~     will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the~     past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence~     of ADHD in adults will be computed.~   "
114787|NCT01553682|"~     Young African-American women who report a higher frequency of alcohol use have particularly~     higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV)~     sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be~     gender- and culturally-appropriate for this population. To address this, the investigators~     propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new~     intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in~     reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined~     Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent~     Horizons+attention control general health promotion (GHP) portion focusing on nutrition~     health promotion, and to an enhanced standard-of-care program. In this study, 600 young~     African American women, 18-24 years of age, who report 3 or more occasions where they drank~     alcohol in the past 90 days will be recruited to complete a four-part baseline assessment~     consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped~     communication role plays to objectively measure communication skill ability (subsample), 3.~     provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After~     participants complete their baseline assessment, they will be randomly assigned to one of~     three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent~     Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET~     alcohol-specific component has shown to be effective in influencing several alcohol-specific~     concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among~     culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to~     increase woman's awareness of the unfavorable effects of alcohol on themselves, their sexual~     decision-making, and their male partner and teaches women strategies to reduce the~     possibility of engaging in sex under the influence of alcohol. In addition, the GMET~     alcohol-specific module provides skills training needed to effectively talk about sexual~     intentions to use condoms and/or refuse risky sex when they or their male sex partner has~     been using alcohol. After completing one of the three conditions, participants will complete~     a brief ACASI posttest to evaluate immediate changes in hypothesized social and~     psychological mediators of safer sex and alcohol use. Participants will also return to~     complete follow-up assessments at 3, 6, 9, and 12-months after their intervention. If the~     Horizons+GMET intervention is observed to be effective, investigators will work closely with~     the CDC DEBI program to help distribute the intervention to public health agencies and~     community based organizations (CBOs).~   "
114788|NCT01553669|"~     The primary hypothesis is, comparing with the control group, reminiscence therapy is~     significantly and clinically effective to improve the experiment group's depressive symptoms~     after six weeks therapy, and the efficacy can be maintained on the three months follow-up.~      The secondary hypothesis is, comparing with the control group, reminiscence therapy~     significantly reduce the loneliness and increase the self-esteem and life satisfaction of~     the experiment group.~   "
114789|NCT01553656|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics~     (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral~     doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors.~     Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients~     with various activating mutations will be evaluated at the recommended Phase 2 dose.~   "
114790|NCT01553643|"~     Intracranial arterial prominent stenosis (IAPS) is one of main cause of stroke especially in~     Asia. Although antiplatelet aggregative or anticoagulant agent and even surgical operation~     are used to treat patients with IAPS, the incidence of stroke occurrence still remains high.~     In addition, symptomatic IAPS most common cause continuous deterioration, thus, increase the~     incidence of stroke. Therefore, there is a good method to reduce the inceidence of stroke~     that is to prevent the progressive deterioration of IAPS.~      Huang-Chi-Wu-Wu-Tang is made of Astrgalus membranaceus (Fisch.) Gge , Paeonia lactiflora~     Pall , Cinnamom Twig , Zingiber officinale Rose , Ziziphus jujube Mill , and can treat~     hemiplegia in the traditional Chinese medicine writings. Astragaloside IV is a component of~     Astrgalus membranaceus, may reduce th cerebral infarction area in middle cerebral arterial~     occlusion mice. The investigators previous studies have known that paeoniflorin that a~     component of Paeonia lactiflora Pall can decrease the cerebral infarction area and~     neurological deficit in middle cerebral arterial occlusion rats. Therefore, the purpose of~     the present study was to investigate the effect of Huang-Chi-Wu-Wu-Tang on patients with~     IAPS.~   "
115130|NCT01549171|"~     Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site~     for early embryo development. The effect of prostacyclin on human early embryo development~     is waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo~     development.~   "
114791|NCT01553630|"~     Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and~     distal tibia are difficult to treat and typically have more complications than other~     metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures~     are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia~     treated with locked plates often have a critical sized fracture gap (poorly organized~     cortical pieces many of which are stripped of soft tissue). Optimal management strategies~     that minimize both fracture healing time and complication rates remain controversial.~     Primary bone grafts or early secondary bone grafts have been recommended for these~     comminuted open fractures, but have not been studied as the primary end point in a~     randomized trial. There is a need to study primary bone grafting during open reduction and~     internal fixation (plating) of these difficult fractures, to determine if shorter healing~     time, and thus less need for reoperation, can be achieved.~      Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and~     radiographic union with a lower need for secondary procedures~   "
114792|NCT01553617|"~     The study will compare the efficacy and safety of VolulyteTM and human albumin in elective~     open-heart surgery in adult patients.~   "
114793|NCT01553604|"~     This study was designed to determine whether the duration of dressing wear following~     augmentation mammaplasty influence skin colonization and eventually surgical site infections~     rates.~   "
114794|NCT01553591|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     different doses of JNJ-27018966 compared with placebo in the treatment of patients with~     diarrhea-predominant irritable bowel syndrome.~   "
114795|NCT01553578|"~     This randomized clinical trial studies healing touch or guided imagery in treating pain,~     fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided~     imagery may help treat complications caused by chemotherapy. It is not yet known whether~     healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and~     anxiety in patients undergoing chemotherapy~   "
114796|NCT01553565|"~     1. Background: The ideal method to remove small colorectal polyps in patients who are~          taking antithrombotic agents is unknown.~        2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete~          retrieval rate after the removal by colon snare transection without electrocautery for~          small polyps in patients who are taking antithrombotic agents.~        3. Design: A prospective, consecutive study.~        4. Setting: Municipal hospital outpatients.~        5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for~          colorectal polyps up to 10 mm in diameter in patients who continue to take~          antithrombotic agents. The primary outcome measure was bleeding within two weeks after~          polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal~          polyps based on the pathological examination.~   "
114797|NCT01553552|"~     SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the~     immune response of children to childhood vaccine antigens, as well as the impact of this~     infection on their nutritional status and their haemoglobinaemia.~   "
114798|NCT01553539|"~     This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line~     therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be~     removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking~     blood flow to the tumor.~      Funding Source - FDA Office of Orphan Drug Products (OOPD)~   "
114799|NCT01553526|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
114800|NCT01553513|"~     This is a single-centre prospective trial with 140 patients employing~     [18F]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance~     motion correction and image fusion algorithms to create motion frozen displays and quantify~     FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree.~     Four groups of patients, two with stable coronary artery disease and two with acute coronary~     syndrome will be compared and the results of FDG PET/CT will be correlated to results of~     invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk~     profile and serum markers of inflammation.~      The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques~     shows a positive correlation with inflammatory activity in coronary plaques and markers of~     plaque vulnerability as well as the risk profile of the patients and serum markers of~     inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect~     high risk patients and provide an important means for risk stratification and optimization~     of patient management.~   "
114801|NCT01553500|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The~     pathogenesis of NAFLD is generally considered the result of a series of liver injuries,~     commonly referred as multi-hit hypothesis. Insulin resistance and increased serum levels~     of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive~     lipid accumulation in hepatocytes resulting in steatosis.~      Has been reported that a diet rich in high-viscosity fiber improves glycemic control and~     lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.~      Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children~     affected by non alcoholic fatty liver disease.~   "
114802|NCT01553487|"~     The aim of the present study is to investigate the effects of vibrating the forearm bone in~     the free limb on muscle strength and bone mineral density of the forearm in patients with~     forearm/elbow fracture.~      A total of 80 patients with forearm/elbow fracture are planned to include in this study.~     Patients will be randomly attained Training or Control group. Training period will be six~     weeks. Patients in the control group will receive standard care for provided for fractures,~     including fixation and rest.Before the start of the study and after six weeks, bilateral~     bone density of distal radius will be measured by DXA. Before trials, grip strength and the~     rest muscle electrical activity of contralateral wrist flexors and extensors will be~     measured. After six weeks, bilateral grip strength and the rest muscle electrical activity~     will be measured.~   "
115145|NCT01548976|"~     The main objective of this study is to perform the linguistic validation of the french~     version of the PISQ-R questionnaire in a population of sexually active (or not) patients who~     have undergone surgery (or not) for stress urinary incontinence or genital prolapse.~   "
114803|NCT01553474|"~     Background:~      - The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study~     participants will provide blood and saliva samples. The samples will be stored for research~     on eye diseases.~      Objectives:~      - To collect blood and saliva samples for AREDS 2 research.~      Eligibility:~      - AREDS 2 research study participants.~      Design:~        -  Participants will provide blood and saliva samples.~        -  The samples will be submitted with personal and medical information. This information~          will be collected during the AREDS 2 procedures.~   "
114804|NCT01553461|"~     Background:~      - Cord blood transplants can treat cancers and other diseases in children and adults. The~     U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under~     certain safety standards. However, most available cord blood units were collected before the~     FDA set these standards. These units may not meet FDA standards, but they do meet similar~     standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units~     that do not meet the new FDA standards may be used for transplants only as part of a~     research study. Doctors want to allow people who need transplants to receive cord blood that~     meets NMDP standards but may not meet FDA standards.~      Objectives:~      - To allow selected cord blood units that do not meet current FDA standards to be used for~     transplant.~      Eligibility:~      - Individuals who need cord blood units for transplant, and who best match cord blood units~     that are not FDA-licensed.~      Design:~        -  Participants will provide consent to receive cord blood that meets NMDP standards but~          may not meet FDA standards.~        -  Participants will remain on the study for observation for up to 1 year after~          transplant, or until they withdraw from the study for personal or medical reasons.~   "
114805|NCT01553448|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from younger patients with~     neuroblastoma.~   "
114806|NCT01553435|"~     Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods~     analgesia and tolerance in Pediatric Intensive Care Unit Patients~   "
114807|NCT01553422|"~     This study assess the relation between intra abdominal pressure and collapsibility index of~     inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.~   "
114808|NCT01553409|"~     The investigators want to investigate the effects of blood donation to blood pressure, to~     iron metabolism and oxidative stress.~      There are results of other studies that show, that there is a positive effect of blood~     donation to high blood pressure, iron metabolism and oxidative stress.~   "
114809|NCT01553396|"~     This study shows an evaluation of the correlation between the muscle strength levels and~     functional autonomy of elderly women.~   "
114810|NCT01553383|"~     Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime~     sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP)~     valve Provent in obstructive sleep apnea. The hypothesis is the efficacy will be better~     than dental device.~   "
114811|NCT01553370|"~     Maintaining a healthy body weight is a major challenge for the majority of Canadians. A~     lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most~     importantly, can be incorporated into daily life with relative ease is essential. This study~     will determine if an effective strategy includes increased physical activity in conjunction~     with higher intakes of dairy products immediately following exercise. Fifty-six overweight~     adult males who do not regularly exercise will be assigned to one of four groups for 12~     weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5~     times per week). Two groups will consume supplemental low fat milk (3 servings per day) with~     one these groups consuming it immediately after exercise while the other will consume it~     either well before or long after the exercise session. The other two groups will consume a~     carbohydrate drink that has the same amount of energy as the low fat milk, with one of these~     groups consuming the drink right after exercise and the other another group will consume it~     either well before or long after the exercise session. Markers of health status including~     body weight, muscle mass, and bone mass will be measured at the start and after the 12- week~     intervention. The investigators anticipate that providing the low fat milk immediately after~     exercise will result in the most favorable changes in health outcomes, and provide a~     realistic lifestyle intervention for overweight individuals to attain a healthy body weight,~     and by doing so, optimize their ability to prevent chronic disease.~   "
114812|NCT01553357|"~     This is an open label, multicenter, exploratory, single arm, two-stage study aiming to~     explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line~     therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).~   "
114813|NCT01553344|"~     The aim of this study is to determine serum sclerostin levels and change in serum sclerostin~     levels in patients with Vitamin D deficiency treated with calcium and vitamin D.~      Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated~     with calcium and vitamin D will be included in the study. This is an observational study.~     The serum sclerostin levels will be measured before and after Vitamin D treatment.~   "
114814|NCT01553331|"~     Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting~     at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is~     another option. The aim is to test the hypothesis that with ultrasonic dissection technique~     a better same day discharge and a shorter operative time can be achieved.~   "
114833|NCT01553084|"~     The overall purpose of this research is two-fold. First, the two smoking cessation~     medication treatments with the strongest evidence of effectiveness have never been directly~     compared. This research will determine how these two treatments compare in effectiveness in~     a head-to-head trial, and which types of smokers benefit most from each. Second, much of the~     data on smoking and health come from studies from many years ago. Today's smokers differ~     from earlier smokers in many ways that could influence the impact of smoking on health~     (e.g., weight, sex, diet, socio-economic status); the proposed work will determine how~     smoking cessation affects cardiovascular and pulmonary health in today's smokers.~   "
116291|NCT01533935|"~     The primary objective of this trial is to investigate the effect of 6 weeks treatment with~     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation~     and exercise tolerance in patients with COPD.~   "
114815|NCT01553318|"~     The purpose of this 10-week study is to determine the effects of a medication called~     Ketotifen on pain sensitivity; and fibromyalgia-related pain.~      Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that~     are known to cause inflammation. It is an antihistamine that reduces the harmful effects of~     histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food~     and Drug Administration (FDA) and has been available in the United States for more than a~     decade. Oral (taken by mouth) ketotifen has been in available in other countries for several~     decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis,~     ketotifen has long track record of safety. To date, the oral form of ketotifen has not been~     approved by the FDA, therefore this study is referred to as an investigational drug study.~     Prior to opening recruitment an investigational new drug (IND) application which included~     scientific data and information regarding human safety plans was submitted to and approved~     by the FDA.~   "
114816|NCT01553305|"~     The purpose of this study is to compare the effectiveness of a supervised high-intensity~     exercise programme followed by an unsupervised exercise programme to an unsupervised~     exercise programme in patients with Rheumatoid Arthritis.~   "
114817|NCT01553292|"~     Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called~     ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is~     needed to adapt the use of large volume surfactant of 4-5 ml/kg.~      The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada~     called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation~     suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on~     CPAP.~   "
114818|NCT01553279|"~     Primary objective~      • To evaluate the concomitant administration of PR5I with two types of MCC vaccines (MCC-TT~     and MCC-CRM)~      Secondary objectives~      Part I~        -  To describe the immunogenicity of PR5I when PR5I is given at 2 months of age and~          concomitantly with MCC vaccines at 3 and 4 months of age~        -  To describe the immunogenicity of MCC vaccines when MCC vaccines are given~          concomitantly with PR5I at 3 and 4 months of age (post-dose 1 and post-dose 2)~        -  To describe the safety of PR5I given concomitantly with PCV-13 and MCC vaccines~      Part II~      • To describe the immunogenicity and safety of Hib-MCC when given at 12 months of age in~     subjects who have received PR5I at 2, 3 and 4 months of age~   "
114819|NCT01553266|"~     The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education~     Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's~     effectiveness in improving patient clinical and care process outcomes.~      The study's hypotheses are that the MDET intervention results in the following outcomes:~        -  Improvement in patient clinical outcomes;~        -  An increase in the proportion of primary care physicians (PCPs) performing patient care~          processes according to clinical practice guidelines;~        -  An increase in the proportion of referrals to, and patients' utilization of, diabetes~          education programs (DEPs).~   "
114820|NCT01553253|"~     Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the~     first week after the operation is a predictive factor for the development of chronic pain,~     but it is unknown whether the risk is more related to one of the different components of~     acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been~     systematically described in terms of type of pain or sensory abnormalities etc. (allodynia,~     hyperalgesia etc.).~      The purpose of the study is to examine whether intensity of components of acute pain is~     predictive for development of chronic pain after cholecystectomy and to characterize the~     chronic pain by quantitative sensory testing.~      DNA-samples are collected to examine genetical factors, important for perception of pain,~     and the development of chronic pain.~   "
114821|NCT01553240|"~     This study uses functional brain imaging and noninvasive brain stimulation techniques to~     study the brain basis of developmental disorders like Autism Spectrum Disorder and Asperger~     Disorder. Functional magnetic resonance imaging (fMRI) and recently approved FDA treatment~     of depression, Transcranial magnetic stimulation (TMS) will be used to study the~     neurocircuitry of certain symptom clusters in developmental disorders.~   "
114822|NCT01553227|"~     Sleep Apnea Hypopnea Syndrome (OSAHS), is common in patients with OHS, compared to single~     Obesity Hypoventilation Syndrome (OHS) or OSAHS ,patients with both of them are more~     susceptible to have serious hypoxia and carbon dioxide retention during sleep, and much more~     likely to result in pulmonary hypertension and cor-pulmonale.~      At present, the most widely and valid method for these patients is the Bilevel Positive~     Airway Pressure (BiPAP) ventilation, while, recently, the investigators discovered a~     completely novel device, namely auto-trilevel Ventilator. In contrast to the traditional~     therapy, auto-trilevel Ventilator has a more flexible expiratory positive airway pressure~     (EPAP), with which it can removing residual obstructive sleep apnea hypopnea events and~     correcting hypercapnia without contradiction. Treated with auto-trilevel ventilator may~     delay the progression of disease and improve life quality. The overall purpose of this study~     is to determine the curative effects of auto-trilevel ventilators on patients with OHS and~     OSAHS.~   "
114850|NCT01552863|"~     This is an open-label (both the physician and healthy volunteer know which medication will~     be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics~     of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and~     eliminated by the body). This study will consist of three parts that will take place over~     approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have~     one dosing period each.~   "
114851|NCT01552850|"~     To estimate the pharmacokinetics and relative bioavailability of oxycodone after~     administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution~   "
114852|NCT01552837|"~     The aim of the study was to determine the pharmacological induced equivalents of~     neurogenesis and synaptic sprouting in the hippocampus, localized volume changes, changes in~     water content and neurochemical changes in the medial temporal regions.~   "
114853|NCT01552824|"~     There are two options of fetal treatment in cases of severe lower urinary tract~     obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study~     confirming the effectiveness of these treatment, specially comparing both techniques. The~     present study aims to investigate the effectiveness of these treatments.~   "
114823|NCT01553214|"~     Background:~      - White blood cells called granulocytes help the body fight infection. People who have had~     chemotherapy or bone marrow transplants may have very low numbers of these cells.~     Transfusions of these cells can help improve the body's ability to fight infection. However,~     most of the cells are located in the bone marrow or spleen, and are hard to collect from~     healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the~     bloodstream to be collected by apheresis. Researchers want to study the best ways to collect~     these white blood cells. They also want to monitor the effects of the injections and~     donations on the volunteer donors.~      Objectives:~      - To improve the amount and quality of granulocytes (white blood cells) collected by~     apheresis for donation.~      Eligibility:~      - Healthy volunteers between 18 and 75 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Initial blood~          tests will be done to check for eligibility.~        -  Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year.~          Donations will not usually be requested more often than every 4 weeks. Donors will be~          allowed to decline participation at any time.~        -  Participants will have one injection of filgrastim 12 to 24 hours before donation. They~          will also have two tablets of dexamethasone 12 hours before donation.~        -  White blood cells will be collected through apheresis. The apheresis will last about 2~          hours.~        -  Participants will be eligible to donate until they reach their 76th birthday.~   "
114824|NCT01553201|"~     Background:~      - Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms~     of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest~     that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to~     see if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms~     in women with pelvic pain.~      Objectives:~      - To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic~     pain.~      Eligibility:~      - Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and~     endometriosis. Pain must be persistent (lasting for at least 3 months).~      Design:~        -  Participants will keep a pain diary and record their pain medication use for a month~          before the first visit.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Participants will also answer questions about their pain~          levels and quality of life.~        -  Participants will receive either botulinum toxin or a placebo (salt water) injection.~          The injection will be given into the pelvic floor muscles through the vaginal wall.~          Participants will take a muscle relaxant like Valium and have anesthetic cream put on~          the vaginal wall before the injection.~        -  After the injection, participants will keep a pain diary for another month.~        -  At a 1-month followup visit, participants will answer questions about their pain. If~          the pain has not improved, all participants may have a botulinum toxin injection (no~          placebo) into the pelvic floor muscles as before.~        -  Participants will have followup visits for up to a year after the initial 1-month~          followup visit.~   "
114825|NCT01553188|"~     Background:~        -  Advanced prostate cancer is treated with surgery or drugs that lower the levels of~          androgens (male hormones) in the body. However, some cancers become resistant to this~          treatment. These types of cancers are known as castration-resistant prostate cancers.~        -  Interfering with the growth of blood vessels that feed tumors can slow prostate cancer~          growth. AMG 386, a new anticancer drug, targets the blood vessels that feed tumors. It~          has been tested for different types of cancer, but not for prostate cancer. Researchers~          want to see if AMG 386 can slow disease progression in men with castration-resistant~          prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that~          are also used to treat advanced prostate cancer.~      Objectives:~      - To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant~     prostate cancer.~      Eligibility:~      - Men at least 18 years of age with castration-resistant prostate cancer.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies. Blood and urine samples will also be collected.~        -  Participants will be separated into two groups.~        -  The first group will have AMG 386 once per week for a total of four doses during a~          28-day cycle. They will also take abiraterone once a day and prednisone twice a day,~          every day of the cycle.~        -  The second group will not have AMG 386. They will take abiraterone once a day and~          prednisone twice a day, every day of the 28-day cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drugs as long as the disease does not~          progress and there are no severe side effects.~   "
114826|NCT01553175|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and find biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid~     tumors.~   "
114827|NCT01553162|"~     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in~     the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples~     from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.~   "
114828|NCT01553149|"~     This randomized phase II trial studies how well low-dose lenalidomide works compared with~     high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or~     optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment~     (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may~     stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known~     whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in~     treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.~   "
114829|NCT01553136|"~     The purpose of this study is to determine whether varenicline is effective in the treatment~     of alcohol dependence in smokers.~   "
114830|NCT01553123|"~     The purpose of this study is to determine whether ulipristal acetate is effective in the~     treatment of females with anemia associated with uterine leiomyomas. The safety of this~     product will also be evaluated.~   "
114831|NCT01553110|"~     This is a study to learn more about the common cold from studying the nasal secretions~     produced during a cold or episode of allergic rhinitis.~   "
114834|NCT01553071|"~     In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that~     causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides,~     has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide~     precursor. This phase I study represents the first clinical trial employing this promising~     combination. The drug administration schedule (fenretinide given on Days 1-5, safingol given~     on Days 1-2 of each 21-day cycle) reflects the in vitro observation that tumor cell exposure~     to safingol increased fenretinide efficacy both during and after safingol administration.~     The total dose of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction~     from the single agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study.~     This fenretinide dose is expected to produce plasma levels in the 30?s ?M. This dose~     reduction has been employed to reduce the potential for overlapping hepatic toxicities~     between these two agents.~      The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to~     1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial~     exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous~     lipases, thereby permitting tolerance of higher total doses fenretinide emulsion~     subsequently administered. The starting dose of safingol in this study, 210 mg/m2/day x 2~     days (420 mg/m2 total), corresponds to 50% of the recommended Phase II safingol dose (bolus)~     determined in the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the~     MTD of single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol~     run-in monotherapy portion of this study), and was selected to provide an adequate safety~     margin against the potential for overlapping toxicities (such as hepatic transaminitis).~      The study has been designed to optimize the safety of this novel combination. Treatment will~     be administered in the inpatient setting. Central venous access will be mandated to avoid~     the potential for hemolysis and thrombophlebitis associated with the preclinical peripheral~     administration of a previous safingol formulation in rats. To reduce the incidence of~     hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients~     will also be encouraged to maintain a low-fat diet during fenretinide administration. Serum~     triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was~     noted in canine studies at the highest dose of safingol plus fenretinide tested, serum~     troponin T levels will be monitored daily. To limit the potential for hepatotoxicity~     resulting from a possible drug interaction observed between intravenous fenretinide,~     ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of~     ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.~   "
114835|NCT01553058|"~     The purpose of this study is to assess the effect of adalimumab (Humira), when compared to~     NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may~     resemble an active substance but has no medical value) injection. The study will compare the~     effects of each on systemic inflammation and cardiovascular disease risk factors in subjects~     diagnosed with moderate to severe psoriasis.~      This study will look for systemic vascular inflammation in subjects with a test called~     FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study~     will also look for cardio metabolic (heart disease and metabolic factors such as diabetes)~     identifiers in the blood. A blood sample will be taken that will look for these markers~     identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to~     move in the body), metabolic factors, and inflammation.~      This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB~     phototherapy or placebo injection on psoriasis activity and severity. The study will also~     compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This~     study will also evaluate subjects' reported outcomes through a questionnaire that will~     assess quality-of-life in subjects living with psoriasis.~   "
114836|NCT01553045|"~     Atrial fibrillation is the most common cardiac arrhythmia. There is a large variation in~     symptoms; from almost none to severe but the reason for this is unclear.~      The investigators aim to find correlations between symptom burden and intracardiac pressure,~     biomarkers and findings with echocardiography in order to find alternative means of~     treatment.~      It is even intended to study the neurohormonal activation directly after the atrial~     fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.~   "
114837|NCT01553032|"~     This is a national multicenter phase IV study to assess acute radiation dermatitis of~     combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced,~     non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).~   "
114838|NCT01553019|"~     The purpose of this study is to find out what effects, good and/or bad, proton radiation~     combined with chemotherapy has on resected pancreatic cancer.~   "
114839|NCT01553006|"~     Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about~     the efficacy of this drug at low and high doses.~   "
114840|NCT01552993|"~     The aim of this study is to see if paracetamol has a pain-relieving effect during eye~     examination in premature infants.~   "
114841|NCT01552980|"~     This is an open-label, phase II study to evaluate the efficacy and safety of a modified~     regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line~     therapy.~   "
114842|NCT01552967|"~     This is an open-label, phase II study to evaluate the efficacy and safety of a modified~     regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the~     first-line therapy.~   "
114843|NCT01552954|"~     Purpose of this study~        1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of~          Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in~          Koreans compared to conventional prescription of medication.~        2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium~          excretion compared to control group, effectively.~   "
114844|NCT01552941|"~     This is a 12 week open label pilot study to determine the efficacy and safety of a~     surgically implanted, electrically active vagal nerve stimulation device in patients with~     active rheumatoid arthritis.~   "
114845|NCT01552928|"~     According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated~     for their ability to prolong the QT interval which represents the duration of ventricular~     depolarization and subsequent repolarization. The primary objective of the study is to~     assess the effect of anagrelide on QT/QTc interval following a therapeutic and~     supratherapeutic dose of anagrelide when compared to placebo and a positive control.~   "
114846|NCT01552915|"~     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in~     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).~   "
114847|NCT01552902|"~     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in~     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).~   "
114848|NCT01552889|"~     This study compares the effects of depression screening and case management to usual care in~     cardiology outpatients with documented evidence of coronary heart disease. Despite strong~     evidence that depression is a risk factor for cardiac events, there is insufficient evidence~     to support the use of depression screening in cardiac patients.~   "
114849|NCT01552876|"~     This study is evaluating the initial fit of toric contact lenses.~   "
114854|NCT01552811|"~     This study investigates the hypothesis that differences in beta-cell mass in patients with~     diabetes and healthy individuals can be monitored by the positron emission tomography (PET)~     tracer [11C]5-hydroxytryptophane.~   "
114857|NCT01552772|"~     This study will test the safety of an aripiprazole injection in subjects with schizophrenia~     that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in~     this study will receive one injection of aripiprazole and will need to stop taking their~     other antipsychotic medication two weeks after the injection. The study will last one month.~     Subjects will be required to come to a clinic for evaluations and drug and urine collection~     five times during the course of the study.~   "
114858|NCT01552759|"~     This study investigates the hormones that the body produces in response to food intake and~     in response to stress, and the way that stress influences food intake. In particular, it~     compares the hormone levels and food intake of people with and without binge eating~     disorder. In order to find out how these appetite- and stress-related hormones are linked to~     brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at~     which regions of the brain are most active during a food-related scenario.~   "
114859|NCT01552746|"~     Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain~     is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is~     believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem~     1 year after surgery, but it is unknown if it is related to acute postoperative shoulder~     pain.~      The purpose of the study is to systematically describe postoperative shoulder pain after~     lobectomy and examine the time progress up to 1 year after surgery.~   "
114860|NCT01552733|"~     Weakness and impairment of the upper limb is a common contributing factor to post stroke~     disability. Specially designed robotic systems have been developed to try to improve this.~     The investigators already know that their use helps improve limb function after stroke when~     it has been present for many months. The investigators do not know whether they can help~     early after stroke and enhance recovery of limb function, and perhaps prevent weakness~     becoming chronic.~      The investigators plan a randomised controlled blinded study to explore the benefits of~     robot assisted therapy early after stroke in 80 stroke survivors. Participants will be~     randomised by 7 days after stroke to standard care or to robotic therapy (40 participants~     per study group).~      Standard of care will be rehabilitation therapy according to local guidelines delivered by~     NHS multidisciplinary team.~      Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in~     first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a~     series of taks including circle-drawing, reaching targets and holding/moving against~     moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation~     will be delivered. This study will take 3 years to complete.~   "
114861|NCT01552720|"~     Data reported by the international registry of acute aortic dissection (IRAD) in not~     sufficient to reflect clinical characteristics of acute aortic dissection in China.~     Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data.~     The aim of this study is analyze changing trend of clinical characteristics of Chinese~     patients with acute aortic dissection.~   "
114862|NCT01552707|"~     The present prospective, randomized study, compares the spinal fusion obtained after~     instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from~     his/her own bone marrow which will be fixed in human bone tissue form a donor), with the~     current procedure that consists in instrumented spinal fusion and the use of each patient's~     bone obtained from his/her iliac crest.~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its~     associated morbidity.~   "
114863|NCT01552694|"~     People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk~     for developing diabetes and heart disease than the general population. They need safe and~     effective treatments that reduce the risk for developing diabetes and heart disease, and~     improve their quality of life. This project will explore whether a new anti-diabetes~     medication (Januvia) with a novel mechanism of action reduces inflammation, and improves~     blood vessel function in HIV infected men and women with several risk factors for developing~     cardiovascular disease.~   "
114864|NCT01552681|"~     The purpose of the study is to find out if the experimental study agent, baminercept, is~     effective in treating patients with Sjögren's syndrome. The study will also determine if the~     study agent can be safely given to patients with Sjögren's syndrome; examine how it affects~     symptoms of the disease; and attempt to understand how baminercept affects the underlying~     mechanisms of Sjögren's syndrome and the immune system.~   "
114865|NCT01552668|"~     The purpose of this research study is to evaluate the effectiveness of an antibiotic called~     fidaxomicin in preventing C. difficile infection.~   "
114866|NCT01552655|"~     The purpose of this study is to elucidate the value of dual-time-point PET/CT in the~     recurrence of breast cancer and to determine whether the method is better than the~     modalities used in the standard work up.~      150 patients with suspected breast cancer recurrence will be included. All patients will~     undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After~     completion of the examinations the early and the late PET/CT scan will be compared with each~     other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious~     findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained,~     the presence of recurrence will be verified with additional imaging follow-up to ensure the~     highest possible confidence. Sensitivity, specificity, accuracy, negative and positive~     predictive value (NPV/PPV) will be calculated for each modality (incl. early and late~     PET/CT).~   "
114867|NCT01552642|"~     The overall purpose of this study is to develop and implement an effective intervention~     program designed to prevent and treat obesity in young children.~   "
114868|NCT01552629|"~     The study will assess the safety and efficacy of QGE031 in the treatment of moderate to~     severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured~     and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of~     the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already~     established as being effective in atopic dermatitis.~   "
114893|NCT01552304|"~     Hypotheses:~        1. Postoperative oxygen therapy significantly improves postoperative oxygenation in OSA~          surgical patients.~        2. Postoperative oxygen therapy do not significantly increase the number of apnea episodes~          and the duration of apnea episodes.~        3. Postoperative oxygen therapy do not significantly increase arterial carbon dioxide(CO2)~          level in OSA surgical patients.~   "
114869|NCT01552616|"~     Critically-ill patients who have long stays in the hospital often face prolonged periods of~     bed rest. It is known that these patient develop profound weakness and debilitation. The~     effectiveness of existing muscle activation devices that could otherwise prevent the onset~     of debilitation in an immobilized patient has not been demonstrated widely in this cohort.~     It is hypothesized that using thermal methods to augment existing muscle activation~     techniques may demonstrate improved performance with no corresponding change in the safety~     profile.~   "
114870|NCT01552603|"~     The purpose of this study is to verify an automated system of blood glucose control in Type~     I Diabetics. The automated system consists of the investigational Artificial Pancreas~     Control software (APC), two blood glucose sensors, and two hormone pumps, one for delivering~     insulin to lower blood sugar, and the second for delivering glucagon to raise blood sugar.~     The blood glucose sensors relays information to the Artificial Pancreas software, which uses~     the Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon~     infusion by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm~     has been verified, but required manual input into the computer and hormone pumps. This study~     differs in that it uses a fully automated system under the control of the Artificial~     Pancreas Control software. The importance of this change is that it is the next step to~     enable outpatient use of automated, closed loop blood glucose control.~   "
114871|NCT01552590|"~     This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum~     sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and~     hyponatremia~   "
114872|NCT01552577|"~     The purpose of this study is to develop and validate eye-tracking measures that can be used~     to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).~   "
114873|NCT01552564|"~     This study investigates the association between the microvascular resistance at the time of~     primary percutaneous intervention, with microvascular obstruction on CMR and blood markers~     of myocardial damage.~   "
114874|NCT01552551|"~     Older adults at high risk of falls will complete the PA Healthy Steps program. This program~     will be implemented by research staff who will follow the training manual and implement the~     program as it was designed to assess the effectiveness of the program. Participants will~     then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in~     which adherence to physician and home safety assessments will be facilitated; and (iii)~     Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy~     Steps. All participants will be followed monthly for 6 months through personal and automated~     telephone interview protocols to ascertain falls and injuries.~   "
114875|NCT01552538|"~     This will be an open label multicenter study of the safety and efficacy of an active~     implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis.~     Patients who complete study SPM-005 will be enrolled in this study at the time of the last~     visit of the preceding study.~   "
114876|NCT01552525|"~     The purpose of the study is to determine the association between acute kidney injury and~     serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive~     influence on mortality, renal function and on arterial stiffness.~   "
114877|NCT01552512|"~     This randomized, controlled effectiveness study examines Nutributter programming within an~     integrated package of maternal and child health services offered by Haiti's Ministry of~     Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the~     process evaluation is to better understand the uptake of Nutributter® as a complementary~     food in the diets of young children and its feasibility and acceptability as part of MSPP's~     package of services. This project is being carried out at a public hospital in Fort San~     Michel, an impoverished community outside of Cap Haitien, Haiti.~   "
114878|NCT01552499|"~     The purpose of this study is to determine whether the EpiFix human amniotic membrane is~     effective in the treatment of diabetic foot ulcers.~   "
114879|NCT01552486|"~     Comparisons of surgical and non-operative treatment of patients with acute sciatica~     secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable~     difference in outcome. The composition of the non-operative treatment of this patient~     population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value~     in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic~     benefit through the modulation of in vivo inflammatory mediators. This feasibility study~     will define the key experimental variables required to conduct a large multicentre study~     that will clarify the biological and clinical outcomes of SMT in the treatment of patients~     with AS/LDH.~   "
114880|NCT01552473|"~     This study is being done to improve the ability to diagnose and to achieve higher-levels of~     functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain~     Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than~     12 months).~   "
114881|NCT01552460|"~     The purpose of this study is to explore the effects of genes and genetic variation on brain~     structure and function. Investigators at Harvard plan to explore the relationship between~     candidate genes that affect cognitive performance and brain structure/function. Since brain~     phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show~     greater sensitivity than cognitive performance to measure gene effects.~   "
114882|NCT01552447|"~     The purpose of this study is to determine whether the EpiFix human amniotic membrane is~     effective in the treatment of venous leg ulcers.~   "
114883|NCT01552434|"~     The goal of this clinical research study is to find the highest tolerable dose of Avastin~     (bevacizumab) and Torisel (temsirolimus) that can be given in combination with either~     valproic acid or cetuximab to patients with advanced cancer that is refractory. The safety~     of this drug combination will also be studied.~      Bevacizumab is designed to block the growth of blood vessels, which may help to slow or~     block the growth of cancer.~      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells~     to die.~      Valproic acid is an anti-seizure drug that may be able to activate tumor-fighting genes,~     causing cancer cells to die.~      Cetuximab is designed to block a certain protein, called EGFR, that is thought to cause~     cancer cells to grow. This may cause cancer cells to die.~   "
114909|NCT01552083|"~     The purpose of this study is to evaluate the feasibility and the effectiveness of sleep~     apnea screening program for patients at risk in community pharmacies.~   "
114884|NCT01552421|"~     Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to~     severe pain until the first postoperative day. This will subside during the second and third~     postoperative day [1]. A feeling of low general well-being will also be present until the~     first postoperative day and subside during the next couple of days [2].~      To achieve faster recovery after laparoscopic interventions it has been shown that a~     reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative~     pain [3,4].~      A new minimal invasive surgical technique is based on the principle of completely~     eliminating the use of ports through the abdominal wall. This new technique is called~     Natural Orifice Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal~     invasive access to the abdominal cavity through the body's natural openings like the mouth~     and stomach, anus, urethra and vagina. With the NOTES technique one can completely avoid~     incisions in the abdominal wall and thereby reduce the surgical trauma. The benefits of this~     technique is a reduction of postoperative pain, elimination of incisional hernias,~     prevention of wound infections, reduction of peritoneal adherence formation, achieving a~     faster recovery and a better cosmetic result [7,8].~      The most documented and well-described way for gaining NOTES access to the abdominal cavity~     is through the vagina, transvaginal (TV). TV NOTES has mainly been used for cholecystectomy~     because of the direct line of vision to the upper abdomen and gallbladder that is achieved~     through this opening.~      Compilation of results show that TV NOTES cholecystectomy can be implemented with low~     complication rates [20-22]. One retrospective case-control and one prospective observational~     study report less postoperative pain, reduced consumption of analgesics and faster recovery~     for TV NOTES compared to conventional laparoscopic cholecystectomy [23,24]. To date there~     are no systematic prospective randomized data on whether or not TV NOTES cholecystectomy~     leads to a better surgical outcome.~      In the present study the postoperative course after TV NOTES cholecystectomy will be~     compared to laparoscopic cholecystectomy in a prospective randomized and blinded trial. The~     outcome of the randomization between the two surgical techniques will be blinded to patient~     and the nurse staff for the first 72 hours after the operation. The primary outcome~     parameter will be postoperative pain score during the first 24 hours. Secondary outcome~     parameters are postoperative pain score for the first 72 hours, fatigue, well-being, nausea,~     consumption of analgesics, complications, cosmetic result and sexual function.~      The hypothesis being that TV NOTES cholecystectomy gives less postoperative pain, fatigue~     and nausea, a reduction in analgesics and a better cosmetic result and general well-being~     than conventional 4 port laparoscopic cholecystectomy.~   "
114885|NCT01552408|"~     This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of~     ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with~     ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with~     CSME-CI secondary to diabetes mellitus (Type 1 or 2).~   "
114886|NCT01552395|"~     A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice~   "
114887|NCT01552382|"~     We will use a retrospective data analysis to evaluate the association of vitamin D status~     with clinical outcome in cardiac surgical patients. The occurrence of several postoperative~     adverse events such as myocardial infarction, low cardiac output syndrome, stroke and~     in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will~     assess the association of vitamin D status with the duration of mechanical ventilatory~     support and intensive care unit stay from cardiac surgery to discharge. Moreover,~     in-hospital stay will be assessed according to vitamin D status.~   "
114888|NCT01552369|"~     This is a study of two different approaches for the prevention of CMV disease in liver~     transplant recipients. The primary purpose is to determine if Preemptive therapy is the same~     or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative~     recipients that receive a CMV positive liver transplant. Patients meeting study criteria and~     who have provided informed consent will be randomized within 10 days of transplant to~     receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg~     orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV~     viremia by plasma PCR) for 100 days with initiation of oral valganciclovir 900mg orally~     twice daily only at onset of CMV viremia and continued until plasma PCR is negative on two~     consecutive weekly PCR tests.~   "
114889|NCT01552356|"~     This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in~     treating patients with solid tumors that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced) or does not respond to treatment~     (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that~     tumors need to grow. Studying samples of blood in the laboratory from patients receiving~     pazopanib hydrochloride may help doctors learn more about the effects of the body on the~     drug. It may also help doctors understand how well patients respond to treatment.~   "
114890|NCT01552343|"~     The purpose of this study is to assess psychometric properties (reliability and validity) of~     the Nocturia Impact (NI) diary.~      To assess the association between reduction of number of nocturnal voids and the mean~     changes in NI scores(sensitivity of the NI total score to change in nocturia).~      To assess which NI diary items account for the main difference in change in total NI score~     in treatment versus placebo.~   "
114891|NCT01552330|"~     The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification~     of early detection as well as treatment monitoring in malaria infection. It is widely~     accepted that the development of resistance can be delayed by the use of combination~     therapy, especially combinations that include artemisinin derivatives (acts). As the~     resistance problem is considered extremely serious; as a consequence, who has recommended~     that all monotherapy for malaria should be stopped.~      Current WHO guidelines recommend that the drug combination regimens using ACT with effective~     partner medicines should be used to decrease the risk of development or spreading of~     artemisinin resistance.~   "
114892|NCT01552317|"~     Patients with kidney disease benefit from reducing the amount of salt in the food that they~     eat. The benefits include lower blood pressure and better kidney function. Therefore,~     lowering the amount of salt that is eaten could reduce the number of people who will develop~     kidney failure. The effect on blood pressure could also reduce the number of strokes and~     heart attacks. Similar benefits are also seen for people without kidney disease.~      Guidelines for patients with kidney disease recommend that they lower the amount of salt~     that they eat, but most patients do not manage to do this. The reasons for this are not~     unclear, but are likely to reflect the difficulty that patients have in reducing the amount~     of salt in their food and the nature of the advice that they are given.~      The investigators have developed a package of interventions to help patients to make~     healthier choices that will lower their salt intake. The package helps patients to learn~     about salt in food and how to avoid it. It provide practical advice on cutting down on salt~     using information booklets, text messages, emails, telephone calls, and a website.~      Participants will be recruited from hospital kidney clinics and general practice. The~     investigators will randomly allocate participants to receive either the normal care that~     they would get or to receive the new package of interventions to help them lower salt. The~     package of interventions will involve patients receiving text messages, telephone calls,~     emails and written information. They will complete a questionnaire and collect urine samples~     which will can be used to measure the amount of salt that they are eating. No more than 6~     visits will be required. The study is funded by the British Renal Society which is a charity~     that funds research to help patients with kidney disease.~   "
114894|NCT01552291|"~     Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic~     diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress~     immune function, exaggerate stress response and cause organ system dysfunction. Increased~     susceptibility to infection, protracted wound healing, impaired blood clotting and vessel~     wall fragility have been shown to be the leading causes of postoperative morbidity and~     mortality in malnourished patients undergoing major surgical resections.~      This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot~     study in a academic single center in Switzerland. A total of 50 malnourished patients with~     gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period~     of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration~     is feasible, well tolerated, will decrease postoperative morbidity, will suppress~     postoperative cell damage and inflammatory response, and will improve the perioperative~     immunocompetence of the patients.~   "
114895|NCT01552265|"~     This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who~     convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the~     conversion.~   "
114896|NCT01552252|"~     The null hypothesis tested was that there are no differences in the taste palatability of~     the apple juices before and after adding POs-Ca.~   "
114897|NCT01552239|"~     RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to~     minimize morbidity and maximize efficacy. An additional boost dose can be provided locally~     by HDR-brachytherapy in patients with positive margins after tumor resection.~      PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern~     radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue~     (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works~     in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.~   "
114898|NCT01552226|"~     This is a prospective randomized study of 114 patients. The purpose of this study is to~     compare the efficacy of two standard methods of analgesia for pain control in patients~     undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS)~     and by the need for supplemental narcotic analgesics. This study is designed to determine if~     postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q~     Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).~   "
114899|NCT01552213|"~     The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for~     pregnant women with prediabetes decreases the rate and severity of impaired glucose~     tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of~     obesity and diabetes in this country even among young women and the adverse affects of~     diabetes of pregnant women and their infants, the investigators feel that it is important to~     not only identify women at high risk for diabetes early in pregnancy but determine the~     appropriate management strategy~   "
114900|NCT01552200|"~     The purpose of this study is to compare the additional diagnostic yield obtained by~     performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard~     colonoscopy procedure.~   "
114901|NCT01552187|"~     This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of~     colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention,~     and post-operative atrial fibrillation prevention.~   "
114902|NCT01552174|"~     The purpose of this study is to determine the incidence and characteristics of eyelid~     inflammatory disorders during general ophthalmological consultations and to demonstrate~     association between palpebral pathologies and ocular surface pathologies.~   "
114903|NCT01552161|"~     The purpose of this study is to estimate the prevalence of allergic diseases and atopy among~     patients with angiographically confirmed coronary artery disease as well as to assess levels~     of serum allergic inflammation markers in this population.~   "
114904|NCT01552148|"~     Purpose To evaluate whether adding a transversus abdominis plane block in patients~     undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA)~     morphine requirements during the first 24 hours postoperatively.~      Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:~        1. Group treatment TAP (n=23) will receive the following analgesia:~             -  US guided transversus abdominis plane block performed with 40ml of 0.375%~               levobupivacaine (20 ml per side) after general anaesthesia induction, before~               surgical start~             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at~               rest~        2. Group control will receive:~             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at~               rest~      Primary Outcome Measures:~      Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control~      Secondary Outcome Measures:~        -  Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain~          when resting in bed and during cough during the first 24 hours postoperatively~        -  Time to PACU dimission, evaluated as patient's achievement of a White's score > or =~          12/14~        -  Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9~        -  Functional patient capacity as measured before surgery and whenever a White's score >~          or = 12 will be reached (2minute walking test)~        -  Eventual side effects such as nausea/vomiting~   "
114905|NCT01552135|"~     The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin~     when the skin is intact and when the skin is sunburned. The hypothesis is Does~     nanotitandioxide penetrate intact or sunburned skin?~   "
114906|NCT01552122|"~     This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral~     density in osteoporotic postmenopausal women who were previously treated with alendronate.~   "
114907|NCT01552109|"~     The purpose of this study is to describe the clinical profile and current status of the~     diagnosis and management of stable angina in India by non-interventional consulting~     physicians (CP) through a large multicenter observational registry.~   "
114908|NCT01552096|"~     The investigators postulate that the use of pre-incisional peritonsillar infiltration of~     tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic~     consumption, without harmful effects. Therefore, the present study is designed to evaluate~     the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum~     protein, C-reactive protein, and analgesic consumption after tonsillectomy.~   "
114912|NCT01552044|"~     The objective of the study is to evaluate the effect of spironolactone on 16 patients~     presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate~     whether spironolactone can resolve sub retinal fluid in these patients.~      CSCR is a major cause of visual loss in the young population. It is characterized by sub~     retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes~     of the disease remain unknown but a choroidopathy has been suggested. Moreover,~     corticotherapy and stress are known risk factors of CSCR.~      Our preclinical studies have demonstrated that the mineralocorticoid pathway could be~     involved in the control of choroidal blood flow.~      The investigators propose to evaluate the mineralocorticoid receptors antagonist~     spironolactone in the treatment of CSCR.~      Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary~     endpoint: visual acuity gain ≥ 15 EDTRS letters~   "
114913|NCT01552031|"~     Chronic obstructive pulmonary disease (COPD) is a pathological condition whose progression~     is characterized by stable periods broken up by intermittent acute exacerbations of the~     symptoms, during which a severe inflammatory process occurs often requiring hospitalization.~     During exacerbations the risk of death is very high making the social and economical impact~     of such events important.~      The need of rationalize the utilization of health care resources together with the~     optimization of patient's care has prompted the development of models of assistance based on~     home monitoring. At the present time most of the suggested models were based on the~     utilization of diaries for symptoms perceived by the patients. Even if positive results are~     reported in terms of reduction of in hospitalization many COPD patients tend to~     underestimate the severity of their condition and their compliance in recording their~     symptoms rapidly decreases with time.~      Attempts of using more objective measurements such as home spirometers have been done but~     poor results were reported mainly due to the difficulties in performing a spirometric test~     without medical supervision.~      A more suitable approach to get objective information on the function of the respiratory~     system is the Forced Oscillation Technique (FOT). Such methodology is based on the analysis~     of the response of the system to small pressure stimuli over-imposed to the normal breathing~     of the patients. The measurements require minimal cooperation and can be performed without~     medical supervision.~      The purpose of this study is to measure daily variability of FOT data measured at home of a~     group of COPD patients in order to identify possible correlations between symptoms change,~     breathing pattern, lung mechanical impedance and occurrence of exacerbation.~   "
114914|NCT01552018|"~     Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve~     glycaemic control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone~     glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased~     insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in~     atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and~     chemokines associated with atherosclerosis/inflammation.~      The purpose of this study is to explore the effects of 3 months intervention with DPP-4~     inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable~     coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in~     circulating monocytes and adipose tissue.~      A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic~     effect of DPP-4 inhibitors beyond glycaemic control alone.~      Due to reduced sample size (recruitment problems) the main focus has changed and will now be~     on cellular aspects and gene regulation (initially secondary outcome measure).~   "
114915|NCT01552005|"~     The purpose of this study is to respond to The French Health Authority which has requested~     BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a~     representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with~     Saxagliptin to generate real world data on drug utilization, joint population, non~     comparative effectiveness and safety~   "
114916|NCT01551992|"~     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh~     attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring~     1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™,~     Ethicon, Somerville, NJ, USA).~      1.2 SECONDARY OBJECTIVE - To compare laparoscopic sacrocolpopexy anatomic failure rates at 6~     months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture~     (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed~     absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also~     assess mesh erosion rates, costs, and surgeon satisfaction rates.~      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with~     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,~     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique~     using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1~     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,~     Canada) will be less costly than the standard fixation interrupted technique using 0~     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).~      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.~      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique~     based on subjective surgeon satisfaction questionnaires.~   "
114917|NCT01551979|"~     The aim of this study is to look at the effectiveness of repetitive transcranial magnetic~     stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The~     primary outcome is improvement in negative symptoms related to schizophrenia. The~     investigators are focusing on negative symptoms given their greater resistance to~     pharmacological and other established therapies. If the investigators trial were to show~     beneficial effects, its clinical significance would be great.~   "
114965|NCT01551355|"~     As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular~     Institute, a multidisciplinary team design and implemented a pedagogic and communication~     strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included~     educational materials, pedagogical activities and the use of Sesame Workshop healthy habits~     for life materials. For Colombia, the latter were largely developed in collaboration with~     the Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular~     Surgery, Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.~   "
114918|NCT01551966|"~     The portal hypertension (PHT) is the main complication in patients presenting with~     cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric~     varices and can also contribute to the development of ascites, hepatic encephalopathy and~     pleuropulmonary complications.~      In the paediatric population presenting with the PHT, one of every two children develops~     varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule~     endoscopy (VCE) is now routinely used in children for the exploration of the small bowel.~     But the role of the VCE for examination of the other parts of digestive tract still needs to~     be evaluated.~      For the esophagus, the VCE could allow the diagnosis without the need of general sedation.~     Recent studies have shown a good sensitivity and tolerance of this technique for the initial~     diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension,~     but it has not yet been validated for this indication.~      The investigators hypothesize that the VCE could be used in children with similar results in~     term of efficacy, as for adults.~      This prospective simple blind multicentre study (blind for the lecture of the capsule~     endoscopy record), will investigate the diagnostic value of the VCE compared to the~     conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and~     the control of esophageal varices in children.~      If it is provided that the VCE is as efficient as it is for the adults, it could become a~     very interesting alternative to the conventional EGD because less expensive and less~     invasive. Moreover, this technique would be very useful as a means of early detection on the~     EV and/or their control.~   "
114919|NCT01551953|"~     The main purpose of this study is to determine feasibility and effects of tai chi and~     mind-body breathing in patients with COPD.~   "
114920|NCT01551940|"~     Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral~     sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in~     parotids and submandibular glands. The investigators want to demonstrate 1 month after the~     injection, by a multicenter French randomized double blind study, an improvement of at least~     25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale,~     a decrease of the quantity of saliva and a decrease of the embarrassment for the main~     caregiver.~   "
114921|NCT01551927|"~     Aim: To investigate and compare women's and men's expectations before investigation and~     treatment of suspected coronary artery disease and to examine how these expectations are~     met.~      Do women and men, of different ages, have the same expectations for the evaluation and~     treatment of stable coronary artery disease and are their expectations met in a equal~     degree?~      Are there differences in expectations and the fulfilment of these according to age and other~     clinical history variables? Do the findings in the specially developed questionnaire~     designed to gather patients' expectations to the outcome on quality of life and degree of~     angina pectoris relate to their appearance in the designated forms? Is there a relationship~     between NTproBNP - levels, as a measure of cardiac workload, and expectations and the~     fulfilment of these as well as the quality of life and degree of angina pectoris?~      Method: Patients will be asked to participate in the study, in the context of medical~     consultation before coronary angiography by a physician and / or a study nurse. This occurs~     during an outpatient visit at the cardiac clinic at the respective centre. Included are all~     patients planned for elective coronary angiography before possible revascularization during~     a eight month period regardless of diagnosis. Including are four hospitals in the region of~     Västra Götaland.~   "
114922|NCT01551914|"~     The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon~     Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy)~     by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to~     conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation).~     Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii)~     postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques~     (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of~     costs and medical outcomes and (vii) an estimation of the potential impact of new technology~     on the organization of operating rooms (operating time).~   "
114923|NCT01551901|"~     The purpose of this trial is to evaluate the performance, safety and effectiveness of the~     Luna system for the treatment of degenerative disc disease.~   "
114924|NCT01551888|"~     The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and~     tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall~     Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for~     five days to patients with moderate to severe COPD.~   "
114925|NCT01551875|"~     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to~     obtain the distribution of measurements of CIMT in Indian subjects and will involve approx.~     30 investigative sites from all over the country. Each investigative site will be expected~     to enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each~     individual as described in the protocol.~      All the procedures could be completed in a single day, however due to any reason any study~     variable is not taken subject may be asked to come back for a second visit within 7 days of~     the first visit.~   "
114926|NCT01551862|"~     A prospective study on 50 consecutive patients who are going to have a lower body lift~     procedure is performed. Measures include comorbidities and complications. Risk factors~     assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max),~     current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.~   "
114927|NCT01551849|"~     The purpose of this study is to evaluate echocardiographic markers of cardiac function to~     assess the ability of patients to successfully end VA-ECMO support.~   "
114928|NCT01551836|"~     This will be a single centre, open label, randomised, two-way crossover study in healthy~     volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in~     this study to establish at what time point a therapeutic concentration of paracetamol in the~     blood is reached. Subjects will attend a screening visit to check if they are eligible for~     study participation then within 15 days they will check-in to the unit for a stay of~     approximately 48 hours (hrs). They will be given a single dose of one of the preparations on~     the first day and then the other preparation on the next day. Regular blood samples will be~     taken along with other assessments for safety.~   "
114933|NCT01551771|"~     This study is the first administration of GW824575 in humans. This will be a single centre,~     masked, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics~     (PK) and pharmacodynamics (PD) of GW824575, given as single and repeated oral doses to~     healthy male subjects. The study will be comprised of 4 parts and enroll approximately 40~     subjects: Part A will consist of two cohorts of 8 healthy male subjects to assess the~     safety, tolerability, PK, and PD of ascending single oral doses of GW824575. All available~     safety, tolerability, and PK data will be monitored prior to each dose escalation. In order~     to support the possible indication for age-related macular degeneration (AMD), Part B will~     be one cohort of 12 subjects to examine the safety, tolerability, PK, and PD of a repeated~     dose of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50~     years of age. The total daily dose in this cohort will not exceed the maximum tolerated dose~     (MTD) from Parts A and D. Subjects in this cohort will undergo ophthalmology assessments~     before receiving investigational product and after Day 7 of the 21-day in-patient treatment,~     after steady state has been reached. As part of protocol amendment 2, Part C (Cohort 4) is~     removed from the protocol. Part D, added under protocol amendment 2, will consist of one~     cohort of 12 healthy male subjects to assess safety, tolerability, PK, and PD of ascending~     single doses of GW824575 as well as the effect of food on the PK of GW824575.~   "
114934|NCT01551758|"~     This study is designed to compare the effectiveness and safety of Fluticasone~     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg~     Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI)~     compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed~     with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet~     the eligibility criteria are randomised and will enter a 12 month treatment period.~   "
114935|NCT01551745|"~     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with~     bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary~     surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7~     cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every~     2 weeks.~   "
114936|NCT01551732|"~     The purpose of this study is to determine whether adding an interactive biofeedback video~     game to anger control cognitive behavioral therapy is an effective and feasible treatment.~   "
114937|NCT01551719|"~     The general objective of the study is to assess whether the implementation of the antibiotic~     essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of~     infection may improve the outcome of infections compared to using only the standard~     procedures.~   "
114938|NCT01551706|"~     This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect~     of ENI Patented Whole Grape Extract on Antioxidant Status.~   "
114939|NCT01551693|"~     STA9090 is a drug which inactivates or blocks the work of a protein called Heat Shock~     Protein 90 or HSP90. HSP90 is a protein that helps some molecules inside your cells to have~     the right shape. By stopping HSP90's activity, those molecules never get to have the right~     structure of be functional and they are destroyed. The investigators believe that if they~     stop the activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow~     down. In this research study the investigators are looking to see how well STA9090 works in~     stopping the spread of your melanoma.~   "
114940|NCT01551680|"~     Recent pre-clinical and clinical data have indicated that BSI-201 does not possess~     characteristics typical of the PARP inhibitor class. Based on the results from in vitro and~     in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with~     radiotherapy in patients who present with multiple non operable brain metastases. As~     radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201~     has shown no major toxicity against tissues without DNA alterations, the proposed~     combination is expected to provide tumor-selective therapy and leading to a clinical benefit~     improvement.~      Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute~     toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain~     radiotherapy (WBR) and a small molecule BSI-201 in non operable brain metastases.~   "
114941|NCT01551667|"~     The primary objective of this study is to detect differences in anti-S. aureus antibody~     assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia~     due to a chronic wound (cases) and (2) a group of patients with localized chronic wound~     infections (control).~   "
114942|NCT01551654|"~     Colonoscopy is a stressful and unpleasant procedure especially during the passage of the~     endoscope through angulations of colon. Electro-acupuncture is one of the alternative to~     reduce colorectal discomfort. However acupuncture is invasive. This present study explored~     the effectiveness of a non-invasive treatment modality, Transcutaneous Electrical Nerve~     Stimulation over Acupuncture points in reduction of colorectal discomfort during~     barostat-induced rectal distension.~   "
114943|NCT01551641|"~     The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients~     by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal~     cancer receiving chemoradiotherapy were divided into different sub-group according to~     dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added~     thalidomide at random. Efficacy and side effect of thalidomide combined with~     chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on~     esophageal cancer and its clinical safely were assessed.~   "
114944|NCT01551628|"~     The purpose of this study is to determine whether Recombinant Human Arginase 1 (rhArg1)is~     safe and effective in the treatment of patients with Relapsed or Refractory Leukemia or~     Lymphoma.~   "
114945|NCT01551615|"~     Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone~     and In Combination with Vandetanib~   "
114946|NCT01551602|"~     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability~     of AK159 administered to healthy postmenopausal women.~   "
114947|NCT01551589|"~     This study examines contrast advantages and disadvantages of elective or prophylactic nodal~     irradiation in the treatment of esophageal cancer with three-dimensional conformed~     radiotherapy.~   "
114948|NCT01551576|"~     The purpose of our study is to image human prostate tissue using a transrectal photoacoustic~     imaging probe.~   "
114952|NCT01551524|"~     This study is an open label, multicenter study with a dose escalation of Asparec®~     administered once every two to four weeks for two administrations. The primary objective of~     this study is to determine the Maximum Tolerated Dose following one single dose of Asparec~     when administered in a population of patients with relapsed or refractory hematological~     malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which~     are to evaluate the safety of Asparec and to determine the PK profile as assessed by~     measurement of plasma L-asparaginase enzymatic activity following single and repeated doses~     of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be~     measured.~   "
114953|NCT01551511|"~     Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and~     long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered~     as first choice in pain management of CP, resulting in regularly prescription of opioids.~     The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid~     induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to~     treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive~     substance of the cannabis plant, has been shown in previous studies to be a promising~     analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an~     improved pharmacokinetic profile, provides the opportunity to test the analgesic potential~     of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic~     efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal~     pain resulting from CP.~   "
114954|NCT01551498|"~     This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc~     dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid~     function in subjects with autoimmune thyroiditis.~   "
114955|NCT01551485|"~     Sleep after surgery has been found to be very distrubed immediately after major surgery.~     This is also seen after fast-track hip and knee replacement with length of stay of less than~     3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and~     decline in cognitive abilities.~   "
114956|NCT01551472|"~     The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using~     Vitamin E UHMWPE tibial inserts for total knee replacement surgery.~   "
114957|NCT01551459|"~     Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer~     spreads, it is more difficult to treat.~      Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine,~     but they are always looking to find new ways to treat uveal melanoma.~      This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how~     long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.~   "
114958|NCT01551446|"~     This study is to evaluate the variability of several pharmacodynamic measures of kidney~     function, cardiovascular function, cerebral perfusion, and haemodynamics.~   "
114959|NCT01551433|"~     The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal~     of a portion of the stomach and esophagus with re-attachment) there is an association~     between the intraoperative level of oxygen at the site where the esophagus is re-attached to~     the stomach (measured using the Wipox), and the incidence of a disruption at the site of the~     attachment after the surgery.~   "
114960|NCT01551420|"~     The overall study objective is to examine the feasibility, acceptance, and benefits of home~     use of an advanced upper limb prosthetic device as well as the logistical support~     requirements utilized during 3 months of home usage. All participating subjects will enroll~     in Part A of the study which will involve supervised training. Eligible subjects will be~     invited to participate in Part B, the home use portion of the study.~   "
114961|NCT01551407|"~     The objective of the study is to compare Hexvix® flexible cystoscopy and white light~     flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined~     as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.~   "
114962|NCT01551394|"~     This phase III multicentric international randomized trial is designed to compare the~     efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical~     or confirmed late-onset sepsis (LOS).~      The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well~     known and documented in this population.~   "
114963|NCT01551381|"~     The principal objective of this study is to evaluate the safety and tolerability of repeated~     doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The~     secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral~     doses of EV-077-3201-2TBS on platelet function, vascular function, vascular inflammation,~     vascular oxidative stress, renal function and a selection of exploratory parameters and~     biomarkers in type 2 diabetic subjects, as well as multiple dose pharmacokinetics in~     diabetic subjects.~      In order to ensure the safety of the diabetic subjects, initial parts of the study will~     evaluate the safety and tolerability of EV-077-3201-2TBS. In Part A, the safety of different~     doses EV-077-3201-2TBS will be investigated in healthy subjects treated for 4 weeks. In~     parallel, Part B will investigate potential interactions between EV-077-3201-2TBS and ASA in~     healthy subjects. Part C will then investigate the safety, pharmacokinetics and~     pharmacodynamics of EV-077-3201-2TBS in type 2 diabetic subjects with and without~     concomitant ASA therapy.~   "
114964|NCT01551368|"~     Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel~     blockers is fat soluble and therefore is able to cross the blood-brain barrier1.~     Gonadotropin releasing hormone (GnRH) neurons are clustered in the hypothalamus and are~     dependent on calcium flux to release GnRH responsible for the release of~     follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary.~     In a natural menstrual cycle a spontaneous LH surge occurs mid-cycle which triggers~     ovulation. The investigators hypothesized that nimodipine, by blocking calcium channels, may~     effectively suppress the release of GnRH and consequently the natural LH surge.~      In this prospective double-blinded randomized study the investigators will evaluate the~     efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled~     ovarian stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful,~     may represent an inexpensive oral medication as an alternative to the currently used GnRH~     agonists or GnRH antagonists in assisted reproductive technologies like IVF.~   "
114966|NCT01551342|"~     -  This study includes two semi-consecutive parts:~             -  Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect®~               device for identifying bladder cancer cells in urine samples.~             -  Part II Prospective, controlled, blinded part to determine the performance of the~               CellDetect® device in monitoring bladder cancer recurrence in patients with a~               history of TCC, using urine cytology samples~        -  The following subjects will be enrolled:~      Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic~     surveillance, TURT or Cystectomy.~   "
114967|NCT01551329|"~     The purpose of this study is to evaluate the efficacy of ketamine in reducing depressive~     symptoms in subjects with a comorbid major depressive episode and alcohol dependence. The~     investigators hypothesize the following for the present study:~      A single dose of ketamine will induce a rapid, robust and sustained reduction in depressive~     symptoms in subjects with a comorbid major depressive episode and alcohol dependence~     relative to placebo as defined by change in Hamilton Depression Rating Scale total scores at~     72 hours post infusion.~      A single dose of ketamine can be delivered safely, with minimal adverse events or~     complications, in subjects with a comorbid major depressive episode and alcohol dependence.~   "
114968|NCT01551316|"~     In MediciNova's clinical development plan for MN-221, it was recognized that treatment of~     COPD exacerbations may necessitate more than one single i.v. infusion and that patients in~     this population may have more co-morbidities (and concomitant medications) than has been~     generally studied so far. Thus, the primary objective of this clinical study is to determine~     the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to~     placebo with repeated administration over several days in moderate to severe COPD patients~     who may also have co-morbidities and concomitant medications (CM) common in this population.~     Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).~      This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year~     (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human~     clinical trial information.~   "
114969|NCT01551303|"~     The purpose of this study is to learn more about how emotional processing may be affected by~     a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may~     play an important role in the way that the brain perceives information.~   "
114970|NCT01551290|"~     The purpose of this study is to evaluate the effectiveness and safety of infliximab in~     Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine~     and rectum).~   "
114971|NCT01551277|"~     Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the~     distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized~     clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two~     groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n~     = 16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung~     ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright~     spirometer. GBS held three techniques with an interval of three minutes. The GC used the~     same circuit without the occlusion of the expiratory branch. Results: GBS was found to be~     higher in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and~     decrease in abdominal compartment (p = 0.03), whereas the CG showed no difference in~     distribution. Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no~     difference before and after the technical BS and GBS in the GC. Conclusions: The technique~     BS altered the distribution pattern of regional ventilation, resulting in greater~     contribution in lung volume in the lower rib cage, corresponding to activity of the~     diaphragm, with redistribution of volume between compartments.~   "
114972|NCT01551264|"~     Prolonged bracing reduces the rate of clubfoot recurrence. In addition to bracing length,~     other factors, including compliance with bracing, gender, age, severity of clubfoot~     deformity and family history contribute to clubfoot recurrence.~   "
114973|NCT01551251|"~     The purpose of this study is to investigate the effects of tumor associated macrophage (TAM)~     in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and~     outcome of these subjects. Pathologic specimens from tissue bank will be stained by~     immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will~     be analyzed between high or low TAM.~   "
114974|NCT01551238|"~     The purpose of this study is to determine energy expenditure and sleep in response to~     protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of~     time.~   "
114975|NCT01551225|"~     This study will be executed according to a randomized double-blind placebo-controlled trial~     with two parallel groups, treated over the period of 6 months with escitalopram or placebo.~      Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal~     symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is~     more effective than placebo in the control of psychiatric symptoms, in IBS patients with~     panic disorder.~   "
114976|NCT01551212|"~     This trial will evaluate the efficacy of Everolimus in combination tacrolimus versus a~     standard immunosuppressive regimen concerning kidney function in liver transplant~     recipients.~   "
114977|NCT01551199|"~     To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure~     Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid~     posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase~     of the study will examine the feasibility and acceptability of MCET-V.~   "
114978|NCT01551186|"~     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus~     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in~     patients on a ventilator.~   "
114979|NCT01551173|"~     This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended~     Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in~     LDL-C lowering from baseline to week 12 (endpoint) in patients with primary~     hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve~     their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.~   "
115009|NCT01550770|"~     Exploration of the hypothesis that general anesthesia is not a singular threshold but is a~     continuum of central nervous system depression dependent on interpretation of nociceptive~     stimuli.~   "
114980|NCT01551160|"~     Patients in hospital can have unexpected clinical emergencies. When this occurs the Medical~     Emergency Team (MET) are called with the intention of resolving the problem. Previous~     investigations have found that patients who have more than one call during their admission~     have worse outcomes than patients who only have one call. But it has not been established~     why.~      The aim of this research will be to examine these repeated calls and why patients subject to~     them go on to have worse outcomes. A predictive model will be developed to identify~     potential sources of risk. One potential source is poor communication between health care~     providers. An intervention to improve communication around MET calls may provide benefit to~     patients and improve outcomes.~   "
114981|NCT01551147|"~     The primary objectives are~        -  to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on~          early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled~          allergen~        -  to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days~          in patients with asthma~      The secondary objectives are:~        -  to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1~          following allergen exposure, and~        -  to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced~          airway hyperresponsiveness (AHR) as measured by methacholine challenge~   "
114982|NCT01551134|"~     The aim of the study was to compare short- and longterm outcomes after laparoscopic and open~     Nissen fundoplication in children.~   "
114983|NCT01551121|"~     3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance~     system. Patient will be selected by general practitioner and randomized into two groups~     after informed consent. One group will have cameras installed and the other will not and~     will act as a comparison group. Patient will be assessed three times during the study, at~     inclusion, 6 months and 12 months. Each assessment is composed of a standard geriatric~     assessment, a fall questionnaire, an autonomy scale (SMAF scale) and a quality of life~     questionnaire (EQ5D). Every falls will be considered as adverse events and will therefore be~     listed along the study and characterized in types and number.~   "
114984|NCT01551108|"~     This study is designed to determine if parents can deliver an intervention that will help~     increase physical activity in their children. The parents will be given the intervention~     through their mobile phones.~   "
114985|NCT01551095|"~     This research is being done to study the safety of an investigational percutaneous~     endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of~     the J tube prevents it from slipping back into the stomach.~   "
114986|NCT01551082|"~     Discharging patients home with air leak and chest tube to portable drainage device after~     thoracic resection is cost effective and safe without compromising patients outcome or~     satisfaction. Despite good outcomes this practice is not done universally by thoracic~     surgeons.~   "
114987|NCT01551069|"~     Primary Objective:~      - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily~     regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus~     (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI~     [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4)~     concomitant treatment with or without corticosteroid.~      Secondary Objectives:~        -  To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of~          once daily regiment of HCQ versus placebo as the reference group in patients with CLE~          and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant~          treatment with or without corticosteroid.~        -  To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in~          patients with CLE and SLE with active skin manifestation concomitant treatment with or~          without corticosteroid.~        -  To investigate the safety and efficacy of 52 weeks long-term treatment of once daily~          regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose~          reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with~          corticosteroid~        -  To investigate efficacy of once daily regimen of HCQ on systemic symptoms,~          musculoskeletal symptoms and immunological parameters in SLE patients.~   "
114988|NCT01551056|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis~     in the conjunctival allergen challenge (CAC) model.~   "
114989|NCT01551043|"~     The primary objective is to determine the safety and survival of the redirected allogeneic T~     cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).~   "
114990|NCT01551030|"~     The purpose of this study is to learn what effects, good and/or bad, Buparlisib has on~     advanced urothelial cancer. Buparlisib is a pill that works by shutting down some of the~     signals in cancer cells that make tumors grow. It is being tested in patients in research~     studies such as this one. As of 2010, more than 80 patients with various types of cancer~     have received treatment with Buparlisib in research studies.~      This clinical research study is divided into two parts. The goal of the first part of this~     study is to learn if the study drug Buparlisib can shrink or slow the growth of cancer in~     patients with urothelial tumors. The goal of the second part of this study is to learn if~     the study drug Buparlisib can shrink or slow the growth of urothelial tumors in patients~     known to have certain genetic alterations that cause these types of tumors. The study doctor~     will inform the patient which part of the study is currently enrolling participants.~     Participants in both parts of the study will receive the same treatment and tests.~      The safety of this drug will also be studied in both parts. The physical state, changes in~     the size of the tumor, and laboratory findings taken while on-study will help us decide if~     Buparlisib is safe and effective.~   "
115047|NCT01550263|"~     This is an investigatory study to determine whether high levels of pre-operative~     psychological distress predict worse outcomes after hip preservation. This is a low risk~     study and does not alter the treatment or course of care for patients undergoing this~     procedure~   "
115090|NCT01549691|"~     The purpose of this study is to test the level of anxiety in patients, the day before~     surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.~        -  one receiving placebo before going to sleep (before sleep), the day prior surgery and~          placebo when awakening (awakening), the day of surgery~        -  one receiving zopiclone (7.5 mg) before sleep and placebo at awakening~        -  one receiving placebo before sleep and alprazolam (0.5 mg)at awakening~      double blind, randomized controlled study~   "
114991|NCT01551017|"~     Fast Track Recovery Arthroplasty Project is supposed to analyse a new medical method to~     accelerate patient's remobilisation process after total knee endoprostheses. The method,~     called c-treatment, is a computer-controlled cryotherapy (soothing cooling therapy) at which~     the device measures temperature at the affected site (the operated knee in the investigators~     investigation) and optimizes the cooling temperature. The optimized cooling therapy is~     supposed to reduce swelling and postoperative pain whereby patient's postoperative~     mobilization can be done earlier leading to a reduction of length of hospitalization.~      To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split~     in a test group and a standard group. The standard group is treated following the standard~     protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen,~     product code 93.000.00.042). Patient's in the test group receive c-treatment therapy~     following the study protocol.~      All patients are instructed to fill in standardized questionnaires to evaluate social scores~     and pain scores preoperative as well as postoperative. The knee's swelling and range of~     motion as well as blood parameters monitoring the healing process are measured following the~     study protocol.~      The comparison of these parameters between the standard and the test group is supposed to~     verify c-treatment's efficiency.~   "
114992|NCT01551004|"~     Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and~     pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male~     and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per~     Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop~     out. The primary objective of the study is to determine the safety and tolerability of~     escalating doses of CRS3123 following oral administration to healthy subjects. The secondary~     objective is to assess whether there is measurable systemic exposure and if so, to determine~     the plasma pharmacokinetic characteristics of CRS3123 after a single oral dose.~   "
114993|NCT01550978|"~     The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system~     during the course of mechanical ventilation and intubation of critical care patients in~     Intensive Care Unit.~   "
114994|NCT01550965|"~     This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment~     in participants with ulcerative colitis (UC).~   "
114995|NCT01550952|"~     Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain.~     Commonly, patients receive general anesthesia with interscalene block (injection of local~     anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of~     the interscalene block, patients often experience sensory and motor blockade. The purpose of~     this study is to determine the effects of the interscalene block on the anterior deltoid~     muscle and hand grip strength after total shoulder arthroplasty.~   "
114996|NCT01550939|"~     The objectives of this study are to determine the time needed to complete a full set of~     measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement)~     by each test device, the Lenstar 900 Version i4 and IOL Master 500.~   "
114997|NCT01550926|"~     The purpose of this study is to determine whether a new dosage form and dose of orlistat is~     equivalent to the currently marketed form.~   "
114998|NCT01550913|"~     This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy~     (IPT) in treating women with depression and comorbid substance abuse.~   "
114999|NCT01550900|"~     The goal of this clinical research study is to learn if metformin extended release (ER) can~     prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a~     placebo.~      Metformin ER is designed to block a protein in tumor cells that is important in tumor growth~     and blood vessel development. This may cause cell death or reduce the spread of the disease.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
115000|NCT01550887|"~     This study main objective is investigating impulsivity on cocaine or crack addicts. The~     investigators main hypothesis is that different measures (such as scales or behavioral~     tasks, for example) of impulsivity may produce distinct outcomes, and they might also differ~     among cocaine (sniffed) and crack users. Thus, it would be of great value to compare such~     measures once these data are often interpreted as the same phenomenon.~   "
115001|NCT01550874|"~     Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking~     program will result in sustainable enhanced PA.~   "
115002|NCT01550861|"~     The objectives of this study are to evaluate the clinical efficacy of Natural in vitro~     Fertilization and in vitro maturation.~   "
115003|NCT01550848|"~     The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with~     Gemcitabine in the patients with metastatic breast cancer.~   "
115004|NCT01550835|"~     The purpose of this study is to determine whether aspiration thrombectomy following carotid~     stent deployment will reduce the number of procedure related signals as identified by~     diffusion weighted MRI of the brain.~   "
115005|NCT01550822|"~     This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise,~     and smoking cessation) among stroke survivors and result in a reduction in measures of~     general and abdominal obesity.~   "
115006|NCT01550809|"~     Achieving near-normoglycemia has been established as the main objective for most patients~     with type 1 diabetes (T1DM). However, insulin dosing is an empirical process and its success~     is highly dependent on the patients' and physicians' skills, either with multiple daily~     injections (MDI) or with continuous subcutaneous insulin infusion (CSII, the gold standard~     of insulin treatment).~      Postprandial glucose control is one of the most challenging issues in the everyday diabetes~     care. Indeed, postprandial glucose excursions are the major contributors to plasma glucose~     (PG) variability of subjects with (T1DM) and the poor reproducibility of postprandial~     glucose response is burdensome for both patients and healthcare professionals.~      During the past 10-15 years, there has been an exponentially increasing intrusion of~     technology into diabetes care with the expectation of making life easier for patients with~     diabetes. Some tools have been developed to aid patients in the prandial bolus~     decision-making process, i.e. bolus advisors, which have been implemented in insulin pumps~     and more recently in the newest generations of glucometers. Currently, the availability of~     continuous glucose monitoring (CGM) has opened new scenarios for improving glycemic control~     and increasing understanding of post-prandial glycemic response in patients with diabetes.~      Results from clinical studies suggest that sensor-augmented pumps (SAP)may be effective in~     improving metabolic control, especially when included as part of structured educational~     programs resulting in patients' empowerment. Similarly, preliminary results from pilot~     studies indicate that automated glycemic control, especially during nighttime,based on~     information from CGM is feasible. However, automatic management of meal bolus is currently~     one of the main challenges found in clinical validations of the few existing prototypes of~     an artificial pancreas. Indeed, fully closed-loop systems where information about meals size~     and timing is not given to the system have shown poor performance, with postprandial glucose~     higher and post meal nadir glucose lower than desired. This has promoted other~     less-ambitious approaches, where prandial insulin is administered following meal~     announcement (semi closed-loop). However, despite the use of meal announcement, currently~     used algorithms for glucose control (the so-called PID and MPC), show results that are not~     yet satisfactory due to the risk of producing hypoglycemia.~      One of the limitations of the current open-loop (bolus advisors) and closed-loop control~     strategies is that glycemic variability is not taken into account. As an example, settings~     of CSII consider inter-individual variation of the parameters (insulin/carbohydrates ratio,~     correction dose, etc.) but disregard the day-to-day intra-individual variability of~     postprandial glucose response. Availability of massive amount of information from CGM,~     together with mathematic tools, may allow for the characterization of the individual~     variability and the development of strategies to cope with the uncertainty of the glycemic~     response to a meal.~      In this project, a rigorous clinical testing of a CGM-based, user-independent algorithm for~     prandial insulin administration will be carried out in type 1 diabetic patients treated with~     insulin CSII.~      First of all, an individual patient's model characterizing a 5-hour postprandial period will~     be obtained from a 6-day CGM period. The model will account for a 20% uncertainty in insulin~     sensitivity and 10% variability in the estimation of the ingested carbohydrates. Based on~     this model (derived from CGM), a mealtime insulin dose will be calculated (referred as~     iBolus). Then, the same subjects will undergo standardized meal test studies comparing the~     administration of a traditional bolus (tBolus, based on insulin to CHO ratio, correction~     factor, etc.) with the CGM-based prandial insulin delivery (iBolus).~      Significant advances in postprandial control are expected. Should its efficiency be~     demonstrated clinically, the method could be incorporated in advanced sensor augmented pumps~     as well as feedforward action in closed-loop control algorithms for the artificial pancreas,~     in future work.~   "
115007|NCT01550796|"~     The purpose of this research study is to determine if a medication along with a computer~     program designed to improve memory and other mental processes can help people like yourself~     with tinnitus. The medication that will be investigated, d-cycloserine, was developed as an~     antibiotic. However, more recently, research in other studies has shown that this medication~     may enhance learning and memory. The investigators would like to determine if computer~     programs designed to improve memory and attention are enhanced by this medication. In~     addition, the investigators hope to learn if the use of these programs can help participants~     with their tinnitus as well as their ability to remember and focus. All research~     participants will receive therapy with a computer-based program designed to improve memory~     and attention. Half of participants will also receive d-cycloserine while the other half of~     participants will receive placebo. The placebo is a sugar pill without active medication.~   "
115008|NCT01550783|"~     This randomized clinical trial studies home-based HPV or clinic-based Pap screening for~     cervical cancer. It is not yet known whether home-based screening is more effective,~     cost-effective, and/or acceptable than clinic-based screening for cervical cancer.~   "
115010|NCT01550757|"~     Aligning Resources to Care for Homeless Veterans (ARCH) will study ways to best organize~     and deliver primary care for homeless Veterans. The investigators will assess 4 different~     adaptations of the PACT primary care model in a mixed methods study that includes~     multi-center, randomized-controlled trials of embedded peer-mentoring within different~     iterations of the PACT model, focus groups of study participants assessing satisfaction,~     treatment engagement and self-efficacy within the different care models and a cost-utility~     analysis to determine the most cost-efficient approach to organizing care for this~     population. Findings from this study will help determine optimal care approaches for~     reducing emergency department visits and acute hospitalizations, increasing patient~     satisfaction, and improving chronic disease management. Findings from this study will also~     substantively add to our understanding of health seeking behavior and the care of~     vulnerable/high-risk Veteran populations as well as clinical systems design. This project~     reflects a true field-based study to identify optimal and feasible approaches to patient~     care within our current VHA system. Finally, it will help inform pressing policy issues~     relevant to two identified T-21 priority areas: Ending Veteran Homelessness in 5 Years and~     Transforming to a Patient Centered Primary Care model.~   "
115011|NCT01550744|"~     The purpose of the study is to assess the effect of extending maintenance dosing intervals~     beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with~     moderate-to-severe plaque psoriasis.~   "
115012|NCT01550731|"~     Millions of diverse Veterans live with severe and chronic illness for which they will face~     complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered~     chronic care, interventions to prepare Veterans for complex decision-making over the course~     of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of~     a novel preparation guide designed to prepare Veterans to communicate with their surrogates~     and to work with clinicians to make complex, ongoing decisions. The multi-media guide~     teaches communication and preparation skill behaviors (e.g., how to choose a surrogate and~     ask clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th~     grade reading level). This study aims to provide an impetus for changing the paradigm of~     advance care planning policies within the VA by moving beyond documentation of end-of-life~     wishes to the activation of Veterans to participate in ongoing communication of their values~     and goals - a process that is essential to fully realize patient-centered care.~   "
115013|NCT01550718|"~     Alzheimer's disease (AD) is increasing exponentially, with a projected quadrupling of cases~     by the mid 21st century. Individuals with AD are at increased risk for a host of medical and~     psychiatric conditions, and evidence is accumulating supporting the efficacy and~     effectiveness of psychosocial interventions for improving their mood, function, health, and~     quality of life. Such interventions are likely to be most effective when they are~     implemented during the early stages of dementia, when individuals and their family members~     are coping with the initial diagnosis and associated changes in abilities and activities.~     Recent randomized clinical trials by the Principal Investigator and colleagues have~     developed two non-pharmacologic interventions to reduce the social, psychological, physical,~     and behavioral impact of dementia. This investigation is focused on facilitating their~     translation into ongoing community-based programs, such as those provided by Alzheimer's~     Association chapters, senior centers, retirement homes, and other health care providers. The~     core content of each intervention has been retained in order to maintain or improve their~     efficacy, and each has been modified to a 4-week group format to increase efficiency of~     delivery. These modified interventions (ESML-Social and ESML-Ex) will be compared to each~     other and to a usual care (UC) control group. Outcomes will be assessed at baseline, 1-month~     post treatment, and 4 month follow-up. Primary outcomes at the 1-month assessment include:~     social activity participation, family communication, physical activity participation, and~     physical function. Primary outcomes at 4-month follow up include overall quality of life and~     depression. It is hypothesized that ESML-Ex and ESML-Social both will have greater~     improvements than UC. It is hypothesized that ESML-Social will have greater improvements in~     social participation and family communication than ESML-Ex and UC. It is hypothesized that~     ESML-Ex will have greater improvements in physical activity participation and physical~     functioning than ESML-Social and UC. If successful, these 4-week programs may be developed~     into modules that can be incorporated into programming for individuals with early stage~     dementia in a variety of community settings.~   "
115014|NCT01550705|"~     In erythropoietic protoporphyria there is an accumulation of protoporphyrin IX (PPIX) in the~     plasma and liver. The reason it builds up is either the last step to make heme, insertion of~     iron into PPIX, is rate limiting or there is an increase in activity in the first step in~     the heme pathway.~      It may be possible to decrease the amount of PPIX made and see a decrease in symptoms. The~     first step to make heme is the key step in the pathway and it uses vitamin B6 as a cofactor.~     If the investigators can limit the amount of vitamin B6 the investigators can possibly~     reduce the activity of this rate limiting step. With decreased activity of the enzyme it may~     be possible for the body to utilize all the PPIX that is made so that none builds up.~   "
115015|NCT01550679|"~     Even though the main risk factor for the development of chronic obstructive pulmonary~     disease (COPD) is smoking only in less than one third of the smokers the clinically manifest~     COPD will develop. The disease progressive nature with high disability and mortality~     especially in the final stages makes it plausible to detect the disease as early as possible~     thus allowing for the early intervention. Major intervention trials in COPD, Towards a~     Revolution in COPD Health (TORCH), Investigating New Standards for Prophylaxis in Reducing~     Exacerbations (INSPIRE), and Understanding Potential Long-term Impacts on Function with~     Tiotropium (UPLIFT) have recently shown that the beneficial impact of intervention was~     larger in patients being treated in earlier stages of the disease development. Till now the~     only tool for an early diagnosis and early intervention that could be used on the global~     scale was spirometry even though symptoms and deprivation of quality of life (QoL) precedes~     clinically relevant spirometric changes. So there is a need for a new simple tool that would~     allow detection of patients in a very early stage of COPD.~      So the aim of this study is the development of diagnostic tools for an early detection of~     COPD, even before the significant change in spirometry.~   "
115048|NCT01550250|"~     Women who have undergone breast cancer surgery may develop swelling of the arm on the side~     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This~     study will examine night-time compression system garments for lymphedema. Our objective is~     to determine if breast cancer survivors are willing and able to use the garment overnight to~     help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled~     in the 24-week long study. Measurements will be taken of each arm to assess the extent of~     lymphedema and to measure changes over the study period. We will also examine other outcomes~     such as the impact of the night-time compression system garment on sleep. The study will~     provide important information on the feasibility of night-time compression system garments~     as a self-management strategy for lymphedema.~   "
115091|NCT01549678|"~     The hypothesis to be tested is that the use of total contact insoles for six months reduces~     foot pain, improves function and quality of life of patients diagnosed with plantar~     fasciitis.~   "
115016|NCT01550666|"~     People with schizophrenia often have problems with negative symptoms; expressing and~     identifying their emotions, their amount of speech, motivation and interests, feelings of~     purpose, social skills, and experiencing enjoyment. For this reason, new interventions are~     being developed to treat these problems. One new intervention is the Motivation and~     Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly~     meetings for 9 months between a patient and a trainer. The weekly meetings will consist of~     goal setting and organization of the home to make daily tasks more manageable. During the~     weekly meetings the patient and trainer will discuss emotions and the trainer will help the~     patient identify their emotions.~      The researchers hope to learn whether MOVE will help improve the problems. If it works the~     researchers will do a larger study comparing MOVE to other treatments that have addressed~     some of the problems already.~      The therapist will ask you if the sessions can be audio taped to ensure that the therapist~     is doing a helpful job for you. They will also ask if the session can be video taped so that~     the tapes can be used to train other therapists learning about MOVE. The choice to do either~     of these is voluntary and you can continue to participate in the study if you choose not to~     have the session be audio and/or video taped.You will be provided a University Release~     document to provide that permission if you so choose.~   "
115017|NCT01550653|"~     This study examines the hypothesis, that subcutaneous administration of liraglutide, an~     analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in~     healthy humans.~   "
115018|NCT01550640|"~     Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of~     insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the~     lack of opioid administration. Opioids easily cross placental barrier and negatively~     influence newborn postpartum adaptation by respiratory depression. Introduction to GA is~     thus accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia.~     The use of ultra-short acting opioid remifentanil should suppress stress response in mother~     without increasing the risk for newborn. There are only a few clinical data available. This~     study will be the first one systematically studying the influence of remifentanil in~     pregnant women with hypertension on hemodynamic stability and newborns safety. This study~     will also identify potential pharmacogenetic factors of individual variability in~     remifentanil response with respect of drug efficacy and safety in mother and newborn.~   "
115019|NCT01550627|"~     The aim of the study was to evaluate the influence of a systematic extra intravenous fluid~     supplementation during phototherapy in comparison to a fluid supplementation due to short~     term demand in preterm infants.~   "
115020|NCT01550614|"~     The purpose of this study is to determine whether a single intracoronary infusion of~     Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial~     perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8~     weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary~     endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.~   "
115021|NCT01550601|"~     The bariatric surgery is recognized, at present, as the only effective therapeutic for the~     patients with morbid obesity. Two surgical procedures (said restrictive) are considered as~     consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring~     périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy~     (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008).~     It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/-~     antrum). However, lot of technical disagreements are brought back by expert teams. The most~     important disagreement concerns the conservation or the exeresis of the gastric antrum. In~     fact, the conservation of gastric antrum could facilitate the gastric emptying and to~     decrease the RGO (main complication) and act on the regulations of hormones modulators of~     the insulino-secretion.~      A prospective,randomized study comparing these both techniques is necessary to determine a~     unique consensual technique~   "
115022|NCT01550588|"~     Background and hypothesis:~      The appropriate treatment strategy for secondary stroke prevention in patients with~     cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and~     anatomical variables reported to be risk factors associated with stroke recurrence include~     older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm~     (ASA), which, however, were not confirmed by other studies. The investigators hypothesized~     that percutaneous closure of PFO could be an effective option for secondary prevention in~     cryptogenic stroke patients with high-risk PFO.~      Trial Objective:~      The primary objective of this study is to assess whether percutaneous device closure of PFO~     is superior to conventional antithrombotic treatment in preventing stroke recurrence in the~     cryptogenic stroke patients with high-risk PFO.~   "
115023|NCT01550575|"~     This study will evaluate deidentified (anonymous) data in subject medical charts to review~     the clinical outcomes of spinal cord stimulation.~   "
115024|NCT01550562|"~     The purpose of this study is to investigate the effects of varying programming parameters in~     subthreshold spinal cord stimulation therapy for pain relief.~   "
115025|NCT01550549|"~     This study will investigate the performance of physician readers trained to read~     florbetapir-PET scans using electronic media training.~   "
115026|NCT01550536|"~     The primary purpose of this study is to expand research on the effects of physical activity~     on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the~     effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training~     program. The investigators will measure BMR by indirect calorimetry and normalize it across~     subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups~     will be compared: an intervention group (no previous participation in regular exercise,~     newly enrolled in this study's 16 week training program), and a long-term athlete group~     (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). A~     secondary aim is to generate an equation for the prediction of BMR from fat free mass in~     physically active postmenopausal women, to be applied to hypotheses in biological~     anthropology. The investigators expect to find at baseline that, controlling for fat free~     mass and VO2MAX, the long-term group will have significantly higher BMR than the~     intervention group. At 16 weeks the investigators expect no change in BMR for the long-term~     group, while BMR will have increased in the intervention group. At the same time, the~     investigators expect to find that after completing the training regimen, the intervention~     group will have BMR similar to that of the long-term athletes.~   "
115027|NCT01550523|"~     This human Phase I trial involves taking the patient's own tumor cells during surgical~     craniotomy, treating them with an investigational new drug (an antisense molecule) designed~     to shut down a targeted surface receptor protein, and re-implanting the cells, now~     encapsulated in small diffusion chambers the size of a dime in the patient's abdomen within~     24 hours after the surgery. Loss of the surface receptor causes the tumor cells to die in a~     process called apoptosis. As the tumor cells die, they release small particles called~     exosomes, each full of tumor antigens. It is believed that these exosomes as well as the~     presence of the antisense molecule work together to activate the immune system against the~     tumor as they slowly diffuse out of the chamber. This combination product therefore serves~     as a slow-release antigen depot. Immune cells are immediately available for activation~     outside of the chamber because a wound was created to implant these tumor cells and a~     foreign body (the chamber) is present in the wound. The wound and the chamber fortify the~     initial immune response which eventually leads to the activation of immune system T cells~     that attack and eliminate the tumor. By training the immune system to recognize the tumor,~     the patient is also protected through immune surveillance from later tumor growth should the~     tumor recur. Compared to the other immunotherapy strategies, this treatment marshalls the~     native immune system (specifically the antigen presenting cells, or dendritic cells) rather~     than engineering the differentiation of these immune cells and re-injecting them. Compared~     to traditional treatment alternatives for tumor recurrence, including a boost of further~     radiation and more chemotherapy, this treatment represents potentially greater benefit with~     fewer risks.~      This combination product serves as a therapeutic vaccine with an acceptable safety profile,~     which activates an anti-tumor adaptive immune response resulting in radiographic tumor~     regression.~   "
115028|NCT01550510|"~     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment~     with irinotecan versus treatment with irinotecan alone in patients with recurrent or~     advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based~     therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.~   "
115029|NCT01550497|"~     1. Do spinal stabilization exercises demonstrate immediate and long-term effects of weight~          weeks of spinal stabilization exercises as measured by pain intensity and quality of~          life scores?~        2. Does eight weeks of spinal stabilization exercises improve back muscle endurance in~          adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a~          one-time treatment (control)?~      Hypotheses:~      The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal~     stabilization exercises will demonstrate significantly improved pain intensity and quality~     of life scores compared to participants who receive a one-time treatment after eight weeks~     of the intervention period and at six-month follow-up.~      The research hypothesis for Question 2 is: Participants who receive eight weeks of the~     spinal stabilization exercises will demonstrate significantly improved back muscle~     endurance, compared to participants who receive a one-time treatment after eight weeks of~     intervention.~   "
115030|NCT01550484|"~     The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to~     differentiate subjects with Parkinson's Disease from other movement disorders.~   "
115031|NCT01550471|"~     This study will provide the clinicians guidance on the safest combination of inhaled and~     nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;~     however, one safety concern is that these products are independently known to have~     dose-related effects on short term and intermediate term growth. Knemometry is a non~     invasive technique for measuring short-term lower leg growth in children and is currently~     the method of choice in growth studies of short duration. Subjects will be seen on a weekly~     basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.~   "
115032|NCT01550458|"~     The objective of the study is to determine the safety and pharmacokinetics of a 7 day course~     of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation~     study in which the total daily dose of mibefradil will be increased with each cohort.~   "
115033|NCT01550445|"~     The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3~     months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and~     basiliximab. This study is an open-label, prospective, controlled clinical trial in a single~     center. Those patients who fulfill the entry criteria could enter in this prospective~     controlled trial of steroid withdrawal three months after transplantation.~   "
115034|NCT01550432|"~     The rationale for the potential role of antioxidants in the prevention of cardiovascular~     diseases (CVD) remains strong despite the disappointing results of recent trials with a few~     select antioxidant vitamins. Glutathione (GSH) is one of the body's most powerful~     antioxidant agents but there is a surprising paucity of data on its use as an interventional~     therapy.~      Glutathione, when taken orally, is immediately broken down into its constituent amino acids,~     of which cysteine is the only one to be essential. Available cysteine is the critical~     determinant of intracellular GSH concentrations. N-acetyl cysteine (NAC) is an antioxidant~     supplement that has been used to provide a source of cysteine to replete GSH levels. By~     replenishing endogenous glutathione, it is possible that NAC would exert the same effect(s)~     as exogenous GSH.~      However, there is a new delivery system, liposomal GSH, which keeps glutathione intact. In~     this study, the investigators propose to match the cysteine content of NAC and GSH and~     compare the effects of these two supplements, at two different doses, on markers of~     inflammation and oxidative stress.~   "
115049|NCT01550237|"~     The clinical importance of cone beam computer tomography based image guided radiotherapy~     (CT- IGRT) has not been established. The primary aim of the present trial is to investigate~     whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects~     from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning~     target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as~     secondary outcome.~      An open randomised phase III trial. The included men will be randomised to receive curative~     radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and~     standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position~     verification and reduced safety margins (7mm).~   "
115050|NCT01550224|"~     The purpose of the study is to first determine if Temozolomide plus Vorinostat in~     combination can control relapsed or refractory AML and determine if this combination can be~     safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in~     combination and whether the treatment schedule is tolerated.~   "
115051|NCT01550211|"~     This study aims to identify electrophysiological correlates of impaired perceptual and~     linguistic processes in chronic schizophrenic patients, un-medicated first-episode~     schizophrenic patients and their healthy relatives.~      Following administrating some questionnaires (demographic details and psychiatric history~     questionnaire, handedness questionnaire, reading abilities test and positive and negative~     symptoms questionnaire) and performing a perception test and a verbal abstract intelligence~     test, participants will conduct a brain scan during a series of perceptual and linguistic~     tasks.~   "
115035|NCT01550419|"~     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in~     ventilated critically ill patients specially in intensive care unit (ICU). It is associated~     with an increased duration of mechanical ventilation, high death rates and increased~     healthcare costs in China. However, VAP is preventable and many practices have been~     demonstrated to reduce the incidence of this disease, but the morbidity is still so high. So~     much more methods of prevention should be needed to reduce the incidence of VAP.~      Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) present~     anti-inflammatory and immunomodulatory effects besides their ability to regulate cholesterol~     composition. So it is hypothesized that early use of statin may prevent some of the~     infection disease such as VAP.~      Actually, Two studies have showed that statin treatment is associated with reduced risk of~     pneumonia. However, the relationship between statins and reduced risk of pneumonia is not~     consistent.~      After reviewing some of the guidelines,meta analyses and system reviews, the investigator~     find that advanced age,immune suppression from disease or medication and specially depressed~     level of consciousness are the risk factors of VAP. So the investigator assumes that early~     use of statin may give us a favorable outcome in the patients with coma or in the patients~     with severe disease (Acute Physiology and Chronic Health Evaluation II score > 15 or Glasgow~     coma score < 7).~      In addition there is no prospective study to investigate the role of statins in VAP in the~     patients with ischemic stroke. The investigator hopes that this study can approve the~     relationship between statins and reduced risk of VAP in the patients with ischemic stroke.~     And it can improve the processes,outcomes and costs of critical care as well.~   "
115036|NCT01550406|"~     To date, there has been many methods suggested to reduce pancreatic fistula. But there are~     no evidence of superiority to the other methods. This study is a multicenter prospective~     randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to~     prevent of pancreatic fistula after distal pancreatectomy.~   "
115037|NCT01550393|"~     RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help~     doctors identify biomarkers related to cancer.~      PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.~   "
115038|NCT01550380|"~     This is a phase II open label fixed dose study in subjects with advanced, metastatic, or~     refractory endometrial or ovarian, fallopian tube, or primary peritoneal cancer with PI3~     kinase pathway activation as demonstrated by PIK3CA gene mutation, PTEN gene mutation, or~     PTEN null/low protein expression.~   "
115039|NCT01550367|"~     The main goal of the research study is to determine whether treating renal cell cancer~     patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of~     kidney cancer that has spread to other parts of the body, can make the cancer easier to kill~     and eliminate. Another goal is to see how the study drug affects the body's immune cells~     which fight cancer cells.~   "
115040|NCT01550354|"~     Several methods have been demonstrated to improve intubating conditions during sevoflurane~     induction in children. These include opioids, propofol, and addition of neuromuscular~     blocking agents in pediatric patients. But the study about the comparison of these agents~     has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short~     procedure performed under general anesthesia. The investigators aimed to compare intubating~     conditions among children with propofol, alfentanil or rocuronium after sevoflurane~     induction.~   "
115041|NCT01550341|"~     As of July, 2014 the study aims have changed. The revised project, called STRIDE2, is a~     longitudinal, non-randomized, observational study of individuals living with HIV who are~     dependent on opioids. This study is funded by the National Institute on Drug Abuse~     (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason~     University, Yale University, and Howard University. Those individuals originally enrolled in~     the STRIDE RCT will be followed for 12 months.~   "
115042|NCT01550328|"~     The primary objective is to identify device characteristics, components or subsystems that~     manifest as screening score bias in SCOUT DS.~   "
115043|NCT01550315|"~     The investigators will test the hypothesis that markers of vascular endothelial dysfunction~     will be exaggerated acutely with an extreme high sodium diet compared to an extreme~     low-sodium diet. The investigators will compare patients with postural orthostatic~     tachycardia (POTS) to healthy control subjects.~   "
115044|NCT01550302|"~     The investigators want to know whether injecting numbing medication on the side of the neck~     (also called superficial cervical plexus block) can prevent or reduce shoulder pain that~     patients commonly experience after lung surgery. The investigators will perform the~     injection at the end of your surgery while the subjects are still under general anesthesia~     and before they wake up. The investigators will use a local anesthetic (bupivacaine or~     Marcaine®) that is routinely used for skin infiltration of the surgical wounds.~      This study is randomized and single-blind. This means that subjects will be assigned by~     chance (like flipping a coin) to receive either an injection with active medication~     (bupivacaine), or no injection at all.~   "
115045|NCT01550289|"~     The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine~     in India adult subjects.~      Primary Objectives:~        -  To describe the neutralizing antibody response to each dengue virus serotype before the~          first vaccination and after each vaccination with CYD dengue vaccine in all subjects.~        -  To describe the safety of the CYD dengue vaccine after each dose in all subjects.~      Secondary Objective:~        -  To detect symptomatic dengue cases occurring at any time in the trial.~   "
115046|NCT01550276|"~     Background. Headache is one of the most common causes of consultation in primary health care~     and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion~     at the suboccipital level, facilitating the referred head pain.~      Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type~     headache.~      Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and~     a follow-up at one month post-treatment. Eighty-four patients with tension-type headache~     were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included~     manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global~     manipulation, and a combination of both techniques. Outcome measures were: impact of~     headache, disability caused by headache, ranges of motion of the craniocervical junction,~     frequency and intensity of headache, and associated headache symptoms.~      Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01),~     disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue~     inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and~     craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group;~     and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and~     intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated~     headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to~     large.~      Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective~     than suboccipital soft tissue inhibition for tension-type headache. The treatment with~     suboccipital soft tissue inhibition, despite producing less significant results, also has~     positive effects on different aspects of headache.~   "
115056|NCT01550146|"~     Fracture neck of femur is a common cause of hospital admission in the elderly and requires~     operative fixation.~      Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative~     glucocorticoids improve analgesia and decrease opioid consumption with reduction in~     associated side effects in a variety of clinical settings.~      The investigators hypothesis was that a single dose of preoperative dexamethasone enhance~     postoperative analgesia and attenuates the inflammatory response in patients undergoing~     operative fixation of fractured neck of femur, in a prospective, randomized, placebo~     controled trial.~   "
115057|NCT01550133|"~     This study has two main aims: 1) To determine if ingestion of solid or beverage food forms~     will change appetite hormone responses, and 2) To determine whether learning (defined as 2~     week daily consumption) about the metabolic consequence of ingesting solid or beverage foods~     forms varying in energy alters appetite hormone responses.~      Beverage consumption has been implicated in the problem of obesity. However, the exact~     relationship between beverages, lower appetitive response and lower compensatory dietary~     responses remains unclear. This study aims to address this gap in the research. For aim 1,~     the null hypothesis is that the energy in beverage and solid forms will not affect appetite~     hormonal responses differently. The alternative hypothesis is that exposure to the~     energy-yielding beverage will elicit a lower appetitive hormone response compared to oral~     exposure to the solid food form. For aim 2, the null hypothesis is that learning will not~     change appetite hormone responses. The alternative hypothesis is that learning will decrease~     appetite hormone responses in the non-energy-yielding beverage more than in the~     energy-yielding beverage.~   "
115058|NCT01550120|"~     This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds~     change with repeated testing. Threshold testing for NEFA taste has been reported by a number~     of laboratories, including our own; however, these studies have reported data for only one~     testing occasion. The investigators seek to conduct repeated testing to measure the~     test-retest reliability of these methods. The investigators believe that with repeated~     exposure to NEFA, a person's sensitivity increases. The investigators are also testing the~     efficiency of testing by two methods (forced-choice ascending trial versus staircase).~     Additionally, the association between taste responses, diet and BMI will be explored.~   "
115059|NCT01550107|"~     Sarcopenia is defined as the presence of low muscle mass and either decreased muscle~     strength or function. It is increasingly becoming a significant cause of frailty, loss of~     independence and physical disability in ageing western populations. Recent experimental~     evidence has revealed that skeletal muscle is particularly susceptible to damaging molecules~     that result in oxidative stress and that oxidative stress plays a prominent role in the~     development and progression of sarcopenia. The investigators have previously shown that the~     xanthine oxidase inhibitor allopurinol is able to abolish vascular oxidative stress and~     improve endothelial function in cohorts such as optimally treated chronic heart failure and~     chronic kidney disease. Recently, the investigators have also shown that allopurinol~     improves exercise tolerance and time to ST-depression in optimally treated coronary artery~     disease, suggesting that allopurinol could also exert its effects through ATP and/or oxygen~     sparing mechanisms.~      Therefore, we propose a randomised double blind placebo-controlled parallel group trial of~     allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated~     Dilatation to investigate the possible mechanisms that underlie this exciting possibility~   "
115060|NCT01550094|"~     One technique for the nerve block involves injecting the numbing medicine where the nerve is~     together (higher up in the back of the thigh). The other technique involves injecting the~     numbing medicine where the nerve splits into two parts. By injecting numbing medication~     around the nerve(s), there will be less pain after the procedure. It is thought that the~     numbing medicine will be easier to inject in the group that the nerves are split. It is~     expected that subjects may need less pain medication and have lower pain ratings in this~     group too.~   "
115061|NCT01550081|"~     Aerobic interval training is shown to be superior in increasing oxygen uptake in both~     healthy and patients with coronary artery disease (CAD), compared to moderate continuous~     training. However, in cardiac rehabilitation exercise groups, exercise intensity is usually~     controlled with perceived exertion (Borg scale). The investigators will investigate degree~     of agreement between target heart rate and perceived exertion during interval training in~     cardiac rehabilitation.~   "
115062|NCT01550068|"~     Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry~     between the M-protein on the group A β-hemolytic streptococci (GABHS) cell membrane and~     cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart~     Disease (RHD). RHD remains a major contributor to morbidity and premature death in the~     working age population in Nepal. Secondary prevention with regular oral or intravenous~     administration of penicillin continued until early adulthood is recommended to prevent the~     progression of the development of endocarditis and subsequent valvular dysfunction.~      Screening for rheumatic heart disease using echocardiography has the potential to detect~     rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical~     examination alone and might have a beneficial impact on long-term outcome of children with~     RHD. Schoolchildren aged 5-15 years from several public and private schools from rural and~     urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography.~      Three main inter-related objectives will be pursued in three phases of the study: In a first~     phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will~     be investigated among a representative sample of schoolchildren from public and private~     schools in urban and rural areas. In a second phase, using a cohort study approach among~     those children diagnosed at different stages of RHD, clinical outcomes with regular medical~     surveillance will be assessed (a), and clinical and social risk factors associated with~     prognosis of the disease after receiving medical care at various stages of disease at~     diagnosis will be determined (b). A third phase will integrate the prevalence rates from~     phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact~     of screening and RHD treatment on health resource utilization.~   "
115063|NCT01550055|"~     The primary purpose of this study is to evaluate the clinical response and safety of~     cetuximab plus irinotecan synchronously/subsequently in patients with KRAS wild-type~     metastatic colorectal cancer~   "
115064|NCT01550042|"~     Recent studies demonstrated that prolonged rhythm observation increases the detection of~     atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial~     fibrillation in these patients has important therapeutic implications for the~     anticoagulation regimen. However, data on optimal monitoring duration and method of AF~     detection are limited.~   "
115065|NCT01550029|"~     The purpose of this research is to develop and test a new type of smoking cessation~     counseling for individuals with bipolar disorder.~   "
115066|NCT01550016|"~     Improvements in diagnosis of dengue fever and prediction of which patients will get more~     severe disease are urgently needed to improve the treatment of patients with dengue. This is~     very important in places with many people who suffer from dengue but have limited health~     care resources. This study will enroll patients with fever which may be caused by dengue in~     6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El~     Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with~     blood tests and exams until they recover. Symptoms and laboratory tests will be followed so~     that the cause of fever can be determined. For patients who have dengue, the investigators~     will look for symptoms and tests which indicate more serious disease. This study will help~     to determine how to identify patients with dengue fever based on symptoms and simple~     laboratory tests and those who will get more serious disease. It will also help to define a~     more standardized management of patients with dengue fever.~   "
115067|NCT01550003|"~     A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of~     Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active~     Polyarticular-course Juvenile Idiopathic Arthritis (JIA).~   "
115068|NCT01549990|"~     Living-donor kidney transplantation has been considered as the best treatment for patients~     with end-stage renal disease (ESRD). Kidney donation from living donors has been performed~     widely under their noble humanity and a belief that donation would not harm the donor.~     Although the overall evidences proposed that living kidney donor have medical outcomes~     similar to those in general population, several reports have demonstrated the potential~     risks for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be~     concentrated on ensuring their safety and preserving the function of their remained kidney~     during anesthesia maintenance.~      Inhaled anesthetics have been frequently used for the induction and maintenance of general~     anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride,~     which may be directly nephrotoxic through impairments of renal concentrating ability. The~     typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The~     defluorination of sevoflurane can results in increased serum inorganic fluoride ion~     concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human.~     On the other hand, desflurane is extremely resistant to defluorination, and desflurane does~     not appear to be nephrotoxic.~      The inhaled anesthetics which are currently used in general anesthesia have no clinical~     evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially~     in the patients who one kidney is donated. The purpose of the current retrospective, single~     center study was to evaluate and compare postoperative renal function of living kidney donor~     after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based~     recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.~   "
115069|NCT01549977|"~     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared~     to placebo as an add on to stable anti-anginal therapy, on the total exercise time of~     participants with Chronic Stable Angina.~   "
115070|NCT01549964|"~     The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50~     mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus~     metformin on lowering blood sugar.~   "
115071|NCT01549951|"~     The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to~     investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with~     Metastatic Castration-Resistant Prostrate Cancer~   "
115072|NCT01549938|"~     This is a feasibility double-blind randomised controlled trial in 32 participants. It~     evaluates the feasibility of a full trial which will examine the efficacy of weekly~     supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent~     frequency and severity of objectively-verified symptomatic acute respiratory tract~     infection, overall and as a proportion of detected colonisations of the upper respiratory~     tract by 9 of the most common aetiologic viral pathogens.~   "
115073|NCT01549925|"~     The objective of this prospective randomized surgical trial is to evaluate whether the use~     of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women~     with ovarian cancer will reduce the surgical time compared to standard surgical resection~     using clamps and surgical ligatures.~   "
115074|NCT01549912|"~     The primary objective of this research is to examine the result of rotator cuff repairs~     following acute shoulder dislocations and to investigate whether timing of surgery following~     acute shoulder dislocations affects patients perception of pain, function, and strength~     following surgery.~   "
115075|NCT01549899|"~     The objective of this study is to directly compare 6 sessions of in-person and Internet~     administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control~     (MC), within an active duty military population to determine the comparative benefits of~     these interventions on improvement in sleep as well as domains strongly related to insomnia~     such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel~     with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions~     (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The~     investigators will compare these three groups on subjective and objective measures of sleep.~     The CBTi and MC control groups will be compared on other variables of interest (e.g.,~     depression, substance abuse, and PTSD symptoms) and predictors of outcomes.~   "
115076|NCT01549886|"~     The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen~     compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory,~     low-grade or follicular NHL.~      Effectiveness of the experimental regimen will be assessed by complete response rate within~     6 months of study entry (primary endpoint), complete response rate within 3 months of study~     entry, and overall response rate within 6 month of study entry.~   "
115077|NCT01549873|"~     When patients have spinal surgery, electrodes are placed on the body to measure motor evoked~     potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV~     anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At~     this hospital the investigators typically use inhaled anesthesia and are able to~     successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia~     is better than the other for measuring MEP and SSEP.~   "
115081|NCT01549808|"~     Abstract Many patients experience serious reduced functional ability after a critical~     illness and hospitalization in an Intensive Care Unit. The cause of the reduced functional~     ability is the combination of critical illness and immobilization following treatment with a~     ventilator. The functional ability of patients can be affected up till a year after the~     discharge, and may shows a decrease in ability to walk and in problems with focusing.~      Studies show that it is safe and possible to mobilize the patients with for instance bed~     bikes, sitting up and standing up, even during ventilator therapy. The effect is shown as~     lesser days with delirium, on a ventilator therapy or hospitalization. No study has shown~     how early and at which intensity a patient can be mobilized. Our hypothesis is that an early~     systematic mobilization improves functional ability of the critically ill patient, mentally,~     physically and their life expectancy. The purpose of this study is to evaluate a~     mobilization protocol applied at critically ill patients, including a contribute related to~     knowledge of how soon and how intense patients ventilated for more than 48 hours can endure~     mobilization. To evaluate the connections between functional ability and life expectancy for~     critically ill patients are compared to a population matching in age.~      This intervention project has a multicenter design with pre- and post research related to~     effect in early systematic mobilization of critically ill patients. 200 patients are~     included in the project.~      Data are collected at tests showing the functional ability of patients in different ways.~     The tests are made at the discharge from the Intensive Care Unit and 5 days after at their~     wards and again at 3 and 12 month from discharge when the patients have returned to their~     home. The project started in February 2011 and is expected to end in May 2013, findings is~     expected in November 2013.~   "
115082|NCT01549795|"~     Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be~     subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.~      Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent~     in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of~     developing this type of neoplasm. Only a minority of patients are suitable for resection~     partly because of the anatomic position of the tumor (which often arises from the bile duct~     bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is~     currently considered a major contraindication to liver transplantation (OLT) at the majority~     of centers, given a 5-year survival rate of 0%-35%.~      New strategies have been developed for the treatment of this kind of cancer arising in PSC.~     The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a~     neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver~     transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver~     transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5~     years survival. More convincing results come from the Mayo Clinic. An accurate selection of~     patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy~     and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver~     transplantation.~   "
115083|NCT01549782|"~     Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium.~     Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface~     epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal~     inflammation. Modifications in intestinal microbiota, such as an increase in the number of~     pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is~     assessed by its capacity to stimulate the proliferation of healthy bacteria~     (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).~      The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could~     modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients~     affected of gynaecological cancer and treated with abdominal radiotherapy.~   "
115084|NCT01549769|"~     This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in~     patients with chronic kidney disease and type 2 diabetes.~   "
115085|NCT01549756|"~     Find A Cure Panel is looking for people with Stage 4 stomach/gastric cancer or the~     caregivers of people with Stage 4 stomach/gastric cancer to participate in anonymous and~     qualitative research that will take an estimated 60 minutes of your time.~      This is opinion based, experiential research and is NOT a drug trial.~      Note that Stage IV is also known as advance disease or metastatic stomach/gastric cancer.~      If you are interested in participating, please email FACP at: info@findacurepanel.com~   "
115086|NCT01549743|"~     This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and~     rebamipide in healthy male subjects.~   "
115087|NCT01549730|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix~     cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia~     may have an effect on how cervix cancer grows and responds to treatments like radiotherapy~     and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300~     patients. The use of PET scans to measure hypoxia may be better and simpler than the methods~     used previously.~   "
115088|NCT01549717|"~     The investigators plan to study patients who have had cardiac surgery. Current standard~     practice is to monitor patients who have had cardiac surgery using wall-mounted monitors~     whilst they are on the Overnight Intensive Recovery (OIR) and the cardiac High Dependency~     Unit (HDU). The wall-mounted monitors monitor the vital signs continuously and alert the~     nurses if any abnormalities are detected. Once a patient is transferred from HDU to the~     cardiac surgery ward for the most part they are no longer connected to a continuous monitor.~     Instead, the majority of patients on the ward have their vital signs only intermittently~     checked during the day, using a spot check monitor. There is a small minority, chosen on~     clinical grounds, who are assessed with wireless telemetry monitors for a day or two.~      In this study the investigators will continuously monitor the vital signs of all enrolled~     patients from the time that they leave the operating theatre to the the time they are~     discharged from hospital. Whilst they are on OIR and HDU they will be monitored with the~     standard wall-mounted monitors in the normal fashion. When they then move to the ward the~     investigators will give all enrolled patients a telemetry monitor to wear as well as asking~     the nurses to check their vital signs with spot check monitors.~      The investigators will also collect information about the patients' general state of health~     and record indicators of worsening in patients' condition so that the investigators can~     determine how changes in the vital signs relate to deterioration. Finally the investigators~     plan to survey the patients and nurses to understand their experiences of continuous~     monitoring and what needs to be changed to improve the patient experience.~   "
115089|NCT01549704|"~     The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior~     to placebo when it comes to analgetic efficacy in high pain responders after Total Knee~     Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during~     knee flexion the 1. or 2. day after surgery.~   "
116292|NCT01533922|"~     The primary objective of this trial is to investigate the effect of 6 weeks treatment with~     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation~     and exercise tolerance in patients with COPD~   "
115092|NCT01549665|"~     Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic~     stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or~     chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be~     effective for some patients, outcomes of those who are refractory to corticosteroid are~     dismal. Secondary agents can be used for steroid-refractory cases; however, their efficacy~     is variable and usually limited. The quality of life issue of chronic GVHD is especially~     important for pediatric survivors who have longer life expectancy than adults. Many in-vitro~     and in-vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and~     possibilities of treating diseases caused by immune dysregulation such as GVHD. Recent data~     revealed that bone marrow-derived MSCs were very useful to treat steroid-refractory acute~     GVHD, which led to improved overall survival compared with controls. More recently, a number~     of reports suggest MSCs may also be useful in treating chronic GVHD as well as acute GVHD.~     It has been also reported that third party MSCs are also useful as well as those from~     autologous or HLA-matched donors. The investigator recently demonstrated that MSCs obtained~     from umbilical cord blood (UCB) have similar immunosuppressive properties as bone~     marrow-MSCs. UCB-MSCs can be obtained without doing any harm to donors that it may be more~     appropriate source of MSCs than bone marrow for off-the-shelf use. However, little is known~     about the safety and efficacy of UCB-MSCs in treating GVHD. Therefore, the investigator~     designed this study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric~     patients with steroid-refractory acute or chronic GVHD.~   "
115093|NCT01549652|"~     Opioid medications are commonly used for pain relief. When given over time, physical~     dependence can occur. This results in unpleasant side effects--such as agitation and~     nausea--if opioid medications are suddenly stopped. This study aims to test the use of the~     drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the~     progression of opioid physical dependence, thereby allowing future investigators to better~     test the role of physical dependence in the development of addiction and also possibly~     improving acceptance of abstinence-based programs for addiction.~   "
115094|NCT01549639|"~     Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit~     and the operating room. The pharmacokinetics of propofol are difficult to predict in~     patients not conforming to the norms in which the original pharmacokinetic research was~     based. Such patients, including the critically ill, and morbidly obese, are increasingly~     being encountered. The investigators group have been involved in the development of a device~     which can measure blood propofol concentrations, and hope for this to be available to use in~     the operating room in a clinically useful timeframe in the future. Data will be collected on~     patients undergoing propofol based general anaesthesia. The Marsh target controlled~     algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy~     using the propofol monitor. A new proportional correction method will be developed using~     this data, designed to enable recalibration of the TCI algorithm in near real time in order~     to achieve a more accurate estimated propofol concentration in these identified patient~     groups. The research will investigate the effectiveness of a correction of estimated~     propofol levels based on a one off measurement early on in the anaesthetic, and will take~     subsequent samples to measure propofol levels without modifying the TCI algorithm.~     Additionally, data on anaesthetist choice of TCI model, and method of administration in this~     relatively unselected group of patients will be analysed.~   "
115095|NCT01549626|"~     Inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating~     obesity. The hypothesis of this study is to compare the effects of three types of flaxseed~     flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour~     in the sensations of appetite and satiety, lipid profile, pressure levels and associated~     costs in overweight and obese women.~   "
115096|NCT01549613|"~     This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the~     Emergency Department (ED) treatment of complicated skin and skin structure infection in the~     Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who~     are admitted to the RDTC cellulitis protocol in the ED will be randomized to either~     vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or~     daptomycin, which is the experimental treatment in this study. The primary hypothesis is~     that daptomycin treatment is as efficacious as standard therapy in the treatment of ED~     cellulitis.~   "
115097|NCT01549600|"~     The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium~     and microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting~     glucose.~   "
115098|NCT01549587|"~     This study will track changes in oral health in pregnant women. Subjects will be assigned to~     either regular oral care or advanced oral care and be given oral care products to use until~     they deliver. A comparison between the two groups (regular and advanced oral care) will be~     made to see if the oral care products impacted oral health and maternity variables.~   "
115099|NCT01549574|"~     This is an open-label, randomized, cross-over, single dose study in healthy volunteers to~     evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the~     pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of~     crioztinib with or without esomeprazole separated by a washout period of at least 14 days.~   "
115100|NCT01549561|"~     The primary goal of this study is to test the efficacy of two levels of the KEEP~     intervention with adolescents and their foster and kin parents in the San Diego Child~     Welfare System.~   "
115101|NCT01549548|"~     The main purpose of this protocol is to provide expanded access to the study drug~     (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib-~     resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of~     this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that~     have not responded to prior treatment.~   "
115116|NCT01549353|"~     Gum chewing has been reported to stimulate bowel motility after open surgery, such as~     cesarean section and other abdominal surgeries. In general, after laparoscopic surgery~     problems with reduced bowel motility are not as common as after open surgery. In this study~     the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel~     motility after gynecologic laparoscopic surgery. Further the investigators study patient~     satisfaction and potential side effects of postoperative gum chewing.~   "
115102|NCT01549535|"~     The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light~     source and other ancillary equipment. The system is intended for endoscopic diagnosis,~     treatment and video observation of the digestive tract. The PeerScope system model B is~     indicated for use for endoscopy and endoscopic treatment within the lower digestive tract~     (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.~      Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™~     extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.~      In addition, time measurements including time to cecum, time for withdrawal and overall~     procedure time will be analyzed and reported for each group.~   "
115103|NCT01549522|"~     This is opinion based, experiential research and is NOT a drug trial.~   "
115104|NCT01549509|"~     The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not~     infected with HIV. Participants in that study are randomly assigned to receive either the~     HIV vaccine or placebo. This study will enroll people who are participating in the RV 156~     study. In this study, researchers will evaluate the safety of and immune response to a~     different experimental HIV vaccine in people who participated in the RV 156 study.~   "
115105|NCT01549496|"~     The purpose of this study is to evaluate the pharmacokinetic interactions between the~     hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine~     and diltiazem in healthy volunteers.~   "
115106|NCT01549483|"~     The purpose of this study is to study differences in small airways (<2mm) parameters in~     asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.~   "
115107|NCT01549470|"~     Currently, no vaccine prevents HIV infection. This study will test the safety and immune~     responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.~   "
115108|NCT01549457|"~     This study will examine the impact of use of mobile phones and text messaging on adherence~     to treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study~     participants will receive weekly text messages inquiring on their health status in relation~     to their prescribed treatment, while the other half (50%) will not receive weekly text~     messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and~     by interviewing patients at each of these visits.~      The investigators hypothesis is that enhanced communication with a health care provider, via~     a structured cell phone SMS text messaging based program (WelTel), will result in a 15%~     improvement in the proportion of patients who successfully complete their LTBI treatment~     regimens.~   "
115109|NCT01549444|"~     The purpose of this study is to find out if mothers with high blood pressure (Hypertension)~     and/or diabetes have babies with high levels of different substances (that help to regulate~     blood pressure, called Renin and Aldosterone) in their blood. The investigators are also~     trying to determine if these babies have higher blood pressure than those babies born to~     mothers without high blood pressure or diabetes, during the first year of life.~      The investigators will measure your baby's blood pressure once a day for the first 4 days,~     at 1 week of age, and then once per week until your baby is discharged. The investigators~     will also measure the blood pressure after discharge at 4 and 10 months of age, either on~     the day of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit~     to our Outpatient Nephrology Clinic, both at CHEO.~   "
115110|NCT01549431|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     panobinostat and carfilzomib have on the patient's cancer. It will determine the side~     effects of different dose levels of panobinostat and carfilzomib and determine the best dose~     and schedule of the two drugs to recommend for future studies. The study will assess the~     effects of the drug on multiple myeloma. In addition, tests to study the way the drugs work~     will also be done.~      The combination of the 2 drug classes have shown both pre-clinical (studies done in the lab)~     and clinical (studies done with people) effects against multiple myeloma. For this reason,~     these 2 drugs are being studied in combination to determine the side effects and~     anti-myeloma effects of the 2 drugs.~   "
115111|NCT01549418|"~     The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin~     is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to~     compare the risk of significant bleeding after endoscopic polypectomy of large (>=10mm)~     colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid~     (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg~     daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint~     of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints~     are composite cardiovascular events occurring between the date of randomization and 30 days~     after polypectomy.~   "
115112|NCT01549405|"~     Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of~     patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy~     tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib~     level would alleviate postoperative pain and reduce analgesic consumption.~   "
115113|NCT01549392|"~     This study aims to assess the effect of Avastin on brain vascularity and blood-brain~     permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications~     have documented the method by which DECT can determine alterations in vascular volume and~     tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood~     flow cerebral blood volume and permeability-surface area can be generated from the DECT~     studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect~     tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and~     DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not~     receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence~     will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.~   "
115114|NCT01549379|"~     For patients undergoing treatment for head and neck cancer, this study will use dynamic~     contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer~     and require surgical removal.~   "
115115|NCT01549366|"~     The purpose of this clinical investigation is to evaluate the Aspen™ device compared to~     pedicle screw instrumentation for posterior fixation in the treatment of patients with~     degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to~     pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of~     fusion.~   "
115118|NCT01549327|"~     For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information~     and support as well as guidance to access the most appropriate health care services is~     crucial for cancer self-management and support. Timely access to high quality cancer~     information is suggested to contribute to patient empowerment - defined as the perception of~     being better able to manage illness demands. With the advent of the information age,~     individuals are increasingly turning to online health information resources. The use of~     rigorous web-based tools is found to be an engaging and convenient way to access health~     information, while being tailored to people's needs and preferences. The present study seeks~     to examine the effects of a recently developed high quality and person-centred web-based~     tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document~     its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly~     assigned to experimental or control groups with the former having unrestricted access to the~     OIN for 8 months. Participants in the control group will receive care as usual. Information~     on background, medical characteristics, and empowerment will be collected as well as~     cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed~     for national implementation across Canadian cancer centers. Work is currently underway to~     add over 23 types of cancer diagnosis to the OIN.~   "
115119|NCT01549314|"~     The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR~     potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis~     with at least one G551D CFTR mutation.~   "
115120|NCT01549301|"~     The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects~     of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous~     or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy~     subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters~     (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).~   "
115121|NCT01549288|"~     Infantile spasms comprise an infantile epileptic encephalopathy characterized by~     hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the~     treatment of this disorder remains difficult. The first-line options which include hormonal~     therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin~     are effective in 60-70% of the patients. Hormonal therapy is considered the best available~     treatment. Vigabatrin being expensive and of limited availability is not a feasible option~     for most patients in our setting. Also, these are however associated with significant side~     effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and~     levetiracetam have also been evaluated; however these drugs are less effective than ACTH.~     The ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment~     of intractable childhood epilepsy. The KD has also been shown to be effective for~     intractable infantile spasms; often after ACTH and vigabatrin have failed.~      The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy~     that was designed to be a less restrictive alternative to the traditional ketogenic diet.~     This diet is started on an outpatient basis without a fast, allows unlimited protein and~     fat, and does not restrict calories or fluids. Preliminary data have shown efficacy in~     refractory infantile spasms. This diet is also ideal for resource-constraint settings with~     paucity of trained dieticians. Hence this study has been planned to evaluate the efficacy~     and tolerability of the modified Atkins diet in children with infantile spasms refractory to~     hormonal treatment in a randomized controlled trial.~   "
115122|NCT01549275|"~     The purposes of this prospective study were to evaluate the successful rate of primary~     culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the~     residual specimens in routine fine-needle aspiration of hepatic tumor and the potential~     application of this method as an additional tool for personalized treatment of~     hepatocellular carcinoma patients.~   "
115123|NCT01549262|"~     The purpose of this study is to determine whether the multivariable model for embryo~     selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by~     a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison~     with standard incubator and an embryo selection process based exclusively in morphology.~   "
115124|NCT01549249|"~     The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM)~     surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.~   "
115125|NCT01549236|"~     The purpose of this study is to describe the population pharmacokinetics parameters of~     benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.~   "
115126|NCT01549223|"~     The central objective of this study will be to evaluate a standardized, evidence-based~     regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean~     delivery~      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when~     compared to conventional dosing regimen, during elective cesarean delivery will:~      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain~     satisfactory uterine tone.~      Secondary outcomes to be evaluated will be:~        1. Reduce the side effects associated with uterotonic drug use~        2. Reduce the time to establishment and maintenance of adequate uterine tone~   "
115127|NCT01549210|"~     The study aims to identify which characteristics are associated with disability and poor~     quality of life in patients suffering from gout. This is a multicentre prospective~     observational study carried out in a cohort of Italian patients with gout. Subjects are~     randomly selected from a list of patients referred to each participant rheumatology clinic~     in the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months;~     data are retrieved about sociodemographic variables, life-styles, history of gout,~     comorbidities and patterns of treatment. At each visit patients complete questionnaires~     assessing disability and health-related quality of life. Preplanned analyses will be~     performed to investigate predictors of disability and poor quality of life in these~     patients.~   "
115128|NCT01549197|"~     The purpose of the study is to evaluate the quality of the dying process in french ICUs~     (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions~     and experiences, with a one-year follow-up of bereaved relatives.~      Our hypothesis is that perception of the quality of dying may impact on relatives'~     experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress~     disorder (PTSD)).~   "
115129|NCT01549184|"~     Retrospective study of the safety and efficacy of hydroxychloroquine among patients with~     immune Thrombopenia (ITP).~   "
115131|NCT01549158|"~     This is a randomized, open-label, blinded-endpoint, crossover, single dose study to compare~     the pharmacodynamics of Torasemide-PR 10 mg, Torasemide-IR10 mg and furosemide-IR 40 mg. 30~     patients of both sexes with CHF with a maximum imbalance of 60:40% in either direction will~     be included in the study. Patients with compensated heart failure, grade II or III as~     defined by the European Society of Cardiology, with a duration of ≥ 3 months at the time of~     inclusion documented in the patient's record or patients who previously required diuretic~     therapy.~      Principal variable will be the efficiency of sodium excretion that will be assessed as the~     ratio between the average drug-induced natriuresis and the average drug recovered in urine~     over 24 hours.~      The difference between the efficiency of 24 hour sodium excretion following administration~     of torasemide PR and furosemide will be formally tested by means of a Students t-test for~     paired samples. The test will be two-sided at 5% significance level. Efficiency changes over~     time will also be assessed, however will not be subject to formal statistical testing.~   "
115132|NCT01549145|"~     The objectives of this study are to evaluate the safety and efficacy of applying electrical~     stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic~     stimulation regimen.~   "
115133|NCT01549132|"~     The investigators believe that oxygen saturation measurements in the retina may provide more~     information on how well the retina is working and may detect problems in the retina earlier~     than the fundus fluorescein angiography (FFA). This may be useful to an ophthalmologist so~     that they may identify abnormal areas of the retina and commence or change the treatment so~     that they may prevent irreversible blindness.~      Most patients with clinically significant macular oedema and/or ischaemic diabetic~     retinopathy could have either laser or Intravitreal Anti-VEGF injection treatment provided~     they are counseled about the risks. It is known the Anti-VEGF injections reduce oedema and~     it is believed that laser treatment of the retina in this condition improves the oxygen~     supply to the retina and sometimes reverses the damage. It will be useful to take pictures~     of these treated eyes using the Oxymap spectral retinal camera(s) to see whether the~     investigators can detect a change in the oxygen saturation in the retina before and after~     treatment using our oxygen saturation methods.~   "
115134|NCT01549119|"~     The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic~     vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with~     undetectable viral loads.~   "
115135|NCT01549106|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the~     effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.~   "
115136|NCT01549093|"~     The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are~     more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung~     Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is~     a more effective way.~   "
115137|NCT01549080|"~     The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy~     can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the~     same time, evaluate its safety in the treatment of Thalassemia with the syndrome of~     deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.~   "
115138|NCT01549067|"~     Collect the real clinical background of advanced colorectal cancer c of China.~   "
115139|NCT01549054|"~     This is a study in healthy subjects. There are two parts to the study. In the first part of~     the study each subject will receive a single 10mg dose of each of the four formulations of~     E550. Based on the results from Part 1, an optimal formulation will be selected for further~     evaluation in Part 2.~   "
115140|NCT01549041|"~     The investigators propose to explore: 1. the acceptance by patients of once versus twice~     daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing~     with asenapine, and 3. the changes in psychopathology associated with these two dosing~     strategies, in 30 patients with schizophrenia or schizoaffective disorder.~      The investigators hypothesize that patient and staff acceptance will be better with once~     daily dosing and that improvements in psychopathology will be similar across once daily and~     twice daily dosing~   "
115141|NCT01549028|"~     Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of~     osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and~     may impair respiratory function even further if the patient experiences vertebral~     compressions.~      In this study, we will survey the prevalence, correlations and effectiveness of intervention~     of osteoporosis in COPD patients.~   "
115142|NCT01549015|"~     This diagnostic study will be performed to investigate the performance of the urea cycle in~     healthy subjects, asymptomatic carriers of Urea Cycle Disorders (UCD) mutations and subjects~     with genetically proven urea cycle disorders. The ureagenesis rate will be measured by 13C~     incorporation assay, a method for in vivo measurement of urea cycle performance with stable~     isotopes.~   "
115143|NCT01549002|"~     Children can develop abscesses (a collection of pus under their skin) that require a~     physician to cut it open to let the pus drain out. This is a painful procedure. Most medical~     professionals will use numbing cream and inject numbing medicine into the skin, just like at~     the dentist, to help reduce the pain. While this helps minimize the pain of cutting the~     skin, it doesn't help the pain associated with draining out the pus.~      There are many strategies and medications available to physicians to help decrease the pain~     of this procedure. Most of the medications available to treat the pain require the placement~     of an intravenous (IV) catheter through the patient's skin, which itself is a painful~     procedure. In the investigators emergency department, many patients with abscesses that need~     a procedure to drain the pus receive a medicine called morphine through an IV.~      Some pain medicines, however, can be sprayed into a patient's nose, and have been shown to~     be helpful at reducing the pain of a broken bone or a burn. These medicines do not require~     the placement of an IV.~      The purpose of this research study is to determine whether a medicine called fentanyl, when~     sprayed into the nose of patients aged 4 to 18 years undergoing abscess drainage, is not~     worse than IV morphine in decreasing the pain of the procedure.~      After the risks and benefits of the study are explained to patients and their parents,~     written informed consent will be obtained. Written informed assent will be obtained for~     patients older than 8 years of age. Like the flipping of a coin, a computer program will~     decide randomly which half of the patients will receive fentanyl nose spray and which half~     will receive morphine by IV.~      The patients assigned to receive fentanyl nose spray will not have an IV placed. The~     patients assigned to receive morphine will have an IV placed. Both groups of patients will~     have the abscess drainage procedure done the same way. All patients will be videotaped in~     order to score their pain by a trained observer. This score is the main outcome~     (measurement) in the study.~   "
115144|NCT01548989|"~     The main objective of this study is to perform the linguistic validation of a new french~     questionnaire in a population of sexually active (or not) patients who have undergone~     surgery (or not) for stress urinary incontinence or genital prolapse.~   "
115146|NCT01548963|"~     It is known that acute stress of organism often leads to hyperglycemia even in nondiabetic~     patients. It is also known that pathophysiological mechanisms: enhanced gluconeogenesis,~     impaired insulin secretion and decreased insulin sensitivity due to anti-insulin effect of~     stress hormones and proinflammatory cytokines, or changes of glucose excretion and renal~     tubular resorption.~      Many studies proved the negative effects of hyperglycemia to different tissues and organs,~     e.g. hearth (increasing size of myocardial necrosis, reducing coronary collateral blood~     flow, exaggerating ischemia-reperfusion injury, impairing ischemic preconditioning),~     vascular (increased risk of thrombosis, endothelial dysfunction, activation of systemic~     inflammation with destabilization of atherosclerotic plaques), kidneys and its association~     with infectious complications.~      The first Leuven study (published in 2001) demonstrated that hyperglycemia in critical care~     patients significantly increases risk of organ complication and total mortality. Although~     the importance of postoperative tight glycemia control is now widely accepted, glycemia~     stability during cardiac surgery is often neglected. It is known that postoperative~     hyperglycemia has negative effects, but it is not known what effect has its peroperative~     elevation.~      Goal of this study is to demonstrate, whether full perioperative intensive glycemia control~     can reduce the incidence of postoperative morbidity even more than postoperative glycemia~     control only.~   "
115147|NCT01548950|"~     The purpose of this study is to test the hypothesis that treating PAH-CHD patients~     preoperatively with PAH drugs and keeping them on treatment for six months after surgery~     reduces the risk of immediate postoperative death and the risk of residual PAH at six months~     following operation to <10%.~   "
115148|NCT01548937|"~     This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20~     AD depressive); each evaluable subject involved in this study must fulfill all the inclusion~     and exclusion criteria according the subject grouping.~      Safety measurement will be evaluated by medical history, vital signs, physical examinations,~     laboratory examinations and collecting of adverse events.~      This study is expected to be completed in a period of 3 years.~   "
115149|NCT01548924|"~     The investigators plan to study the determination of the dose and the combination of~     antiangiogenic effect of dovitinib and cytotoxic activity of weekly paclitaxel in different~     types of malignant tumors.~   "
115150|NCT01548911|"~     This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works~     in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab~     ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
115151|NCT01548898|"~     Laser causes elimination and miniaturization of hair shafts that are the principal~     contributor to inflammation in Acne Keloidalis Nuchae (AKN).~   "
115152|NCT01548885|"~     The purpose of this study was to evaluate the performance of one investigational Bayer Blood~     Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring~     Systems from other companies. All meter BG results were compared with plasma results~     obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of~     the five systems was evaluated across the glucose range of the BGMSs using capillary blood.~     All testing and lancing were performed by study staff and some blood samples were glycolyzed~     to lower the glucose levels.~   "
115153|NCT01548872|"~     The purpose of this study is to compare two different cardioplegia solutions effect on~     postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.~   "
115154|NCT01548859|"~     The purpose of this study is to compare two different anaesthetic agent effect on~     postoperative Troponin I levels in pediatric cardiac surgery~   "
115155|NCT01548846|"~     This is a study whose main objective is to evaluate prospectively the proportion of patients~     with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.~   "
115156|NCT01548833|"~     The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1®~     silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel~     daily disposable contact lenses.~   "
115157|NCT01548820|"~     On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients~   "
115158|NCT01548807|"~     This is a Phase 1 dose escalation study of an investigational agent, everolimus, given in~     combination with standard radiation therapy, in prostate cancers with a rising PSA following~     a prostatectomy. A maximum of 33 people will be enrolled on this study at the University of~     Pennsylvania. The primary objective of this study is to determine the acute and chronic~     toxicities and maximum tolerated dose of everolimus with concurrent radiation.~   "
115159|NCT01548794|"~     The purpose of this study is the investigation of whether adding lidocaine to hyperbaric~     bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter~     recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy~     procedures.~   "
115160|NCT01548781|"~     Disturbances in movement coordination are the least well understood but often the most~     debilitating with respect to functional recovery following stroke. These deficits in~     coordination are expressed in the form of abnormal muscle synergies and result in limited~     and stereotypic movement patterns that are functionally disabling. The result of these~     constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow~     flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an~     individual with stroke when they lift up the weight of the impaired arm against gravity. The~     investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated~     research grant, has shown that the abnormal synergy between shoulder abduction and elbow~     flexion can be significantly reduced thus increasing total reaching range of motion in~     individuals with severe stroke. The previous work established progressive abduction loading~     as a key element to the rehabilitation of reaching. Although individuals with severe stroke~     benefited from the investigators previous work, residual flexion synergy continued to hinder~     normal arm function in most participants with severe stroke. This study will utilize the~     ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate~     resistance to reaching while accounting for the known benefits of progressive abduction~     loading. The investigators propose to randomize forty participants with severe stroke into~     two closely related interventions. The groups will both practice reaching under abduction~     loading, however, the experimental group will also move against resistance while reaching.~     Rigorous and quantitative investigation of therapeutic elements such as resistance to~     reaching and progressive abduction loading is only possible with a device such as the ACT3D.~     the investigators will be able to standardize the delivery of each intervention using~     kinematic and kinetic parameters, which will allow for a clear identification of the~     therapeutic effect of resistance to reaching. the investigators hypothesize that resistance~     to reaching in combination with progressive abduction loading will further increase dynamic~     multi-joint strength, increase total reaching range of motion, and increase arm function~     thus enhancing actual amount of use of the arm, participation in life roles, and quality of~     life in individuals with severe stroke.~   "
116134|NCT01536028|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics~     and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin~     aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.~   "
115161|NCT01548768|"~     Anti-TNF drugs are a major class of treatment in patients with rheumatoid arthritis (RA).~     Data in non-RA patients with advanced heart failure suggest that anti-TNF agents may not~     help heart failure and may even be harmful. However, the effect of these agents on the~     hearts of RA patients has never been directly studied. However, observational studies~     suggest that anti-TNF agents may actually prevent the onset of heart failure in RA patients~     and may reduce hospitalizations in RA patients who have heart failure. The investigators~     hypothesize that anti-TNF agents in RA patients without heart disease will not adversely~     affect the heart (will not cause a detrimental change in heart structure or its function).~      In order to investigate these hypotheses, the investigators will identify 25 patients who~     have joint inflammation that have not responded adequately to treatment with methotrexate or~     other oral DMARDs . As would happen under standard of care (even without participation in~     the study) patients will receive additional treatment to control their joint disease. The~     investigators will assign these patients to be prescribed (in agreement with the patients~     and their Rheumatologists), a TNF inhibitor in addition to their current treatment.TNF~     inhibitors are an FDA approved treatment for management of RA and have been used by~     Rheumatologists for many years. At enrollment and 6 months after starting treatment patients~     will have imaging of their heart with PET-CT scanning and echocardiogram at both time~     points. Participants will also provide information about their RA and other medical~     conditions and blood will be drawn.~   "
115162|NCT01548755|"~     The purpose of this study is to study workload assessment of home monitoring based follow up~     for ICD or CRTD implanted patient.~   "
115163|NCT01548742|"~     Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in~     serious impairments in interpersonal, occupational and social functioning. Effective~     treatments are available for PTSD but they do not work for everyone. Alternative treatments~     are needed to help those veterans not helped by currently available treatments. Mindfulness~     Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation.~     MBSR has been found to be effective in helping people with problems with pain and anxiety.~     MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR~     with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to~     Veterans' health because of the need to develop alternative treatments for veterans with~     PTSD who have not responded to currently available treatments.~   "
115164|NCT01548729|"~     Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may~     benefit from combined lung-pancreatic islet transplantation. A recent case series showed~     that combined bilateral lung and pancreatic islet transplantation is a viable therapeutic~     option for patients with end-stage CF and CFRD. The use of different organs from a single~     donor may lead to reduced immunogenicity. As the prevalence of CFRD has increased~     dramatically with the improved life expectancy of patients with CF, islet transplantation~     should be considered at the end-stage CF. By restoring metabolic control, the investigators~     hypothesize that islet transplantation may improve the management of CF patients undergoing~     lung transplant and decrease the complication rate in the early postoperative period.~   "
115165|NCT01548716|"~     Hypothesis:~      25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than~     those in HD patients with itching~      25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and~     compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of~     patients complaining of itching.~   "
115166|NCT01548703|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     BCI-838 and its metabolite BCI-632 in healthy male and female subjects.~   "
115167|NCT01548690|"~     This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute~     liver failure/acute liver injury (ALF/ALI) in regard to:~        -  safety and tolerability;~        -  metabolism of the compound to glutamine and phenylacetylglutamine (PAGN);~        -  its effect on circulating ammonia levels and neurological function in patients with and~          without impaired renal function after continuous infusion at different infusion rates.~      Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day~     follow-up visit post infusion. It is anticipated that this early safety and tolerability~     study, with appropriate PK/PD data, will lead to a development program for the use of~     OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver~     conditions. The hypotheses are:~        -  Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute~          liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune~          hepatitis, viral hepatitis or indeterminate etiologies.~        -  A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations~          within 6-12h with little additional accumulation in the ALI/ALF setting.~        -  Treatment with OCR-002 will reduce ammonia and improve neurological function in~          patients with acute liver failure/severe acute liver injury.~   "
115168|NCT01548677|"~     This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer~     (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable~     circulating tumour cells (CTC) in peripheral blood.~      Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the~     observation arm.~   "
115169|NCT01548664|"~     The purpose of this study is to identify whether the utilization of the Nintendo Wii™ gaming~     system, as an adjunct to conventional outpatient rehabilitation therapy, influence outcomes~     of patients following total knee replacement (TKR). The investigators hypothesize that the~     Nintendo Wii™ gaming system has a positive influence in the outcomes of patients following~     TKR.~   "
115170|NCT01548651|"~     The purpose of the study is to examine the effect of saxagliptin, an anti-diabetes~     medication, on hepatic and myocardial fat content and monocyte inflammation in patients with~     Impaired Glucose Tolerance (IGT).~   "
115171|NCT01548638|"~     This is a preliminary open-label study to determine whether a medication called galantamine~     (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that~     smokers experience during a quit attempt.~   "
115184|NCT01548469|"~     The hypothesis of this study is that using Bio Mineral toothpaste for 4 weeks will~     decrease plaque and gingivitis of mild periodontitis patients compared to patients using~     Perio Total Care toothpaste.~      This study is Single blind, Randomized, Active-controlled Comparative clinical trial to~     evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral~     toothpaste in patients with mild periodontitis.~   "
115172|NCT01548625|"~     Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular~     events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as~     a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of~     the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant~     defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure~     on the cardiovascular system in healthy middle-aged subjects.~      Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype~     had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3,~     200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.~   "
115173|NCT01548612|"~     In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain~     unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO~     is a gas with unique chemistry and influences the release of neurotransmitters, learning,~     memory and neurodevelopment. Recent studies that investigated the role of NO in patients~     with schizophrenia found evidence that points to a disruption in NO-mediated~     neurotransmission in schizophrenia. Accordingly, we believe that the administration of~     sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.~   "
115174|NCT01548599|"~     This pilot study aims to determine whether an agricultural intervention will improve food~     security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV~     transmission risk among people living with HIV/AIDS. The intervention will include: a) a~     human-powered water pump and other required farm commodities, b) a micro-finance loan (~$75)~     to purchase the pump and agricultural implements, and c) education in sustainable farming~     practices.~   "
115175|NCT01548586|"~     Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to~     modulate cerebral cortex excitability. It was shown that anodal stimulation increases~     cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et~     al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the~     corticodiaphragmatic pathways. This preliminary study aims to test and validate the~     modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the~     hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in~     patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be~     assessed before and after applications of three different modalities of tDCS (anodal,~     cathodal and placebo).~   "
115176|NCT01548573|"~     This study is designed to decrease toxicity associated with prior tandem transplant~     protocols by reducing the intensity of induction, consolidation and maintenance therapy,~     while increasing event-free survival by adding bortezomib (Velcade®), thalidomide,~     gemcitabine and carmustine to the transplant regimens to down-regulate the rescue of myeloma~     cells by the micro-environment and to prevent DNA repair post high-dose alkylating agent~     therapy. By reducing drug resistance, it is hoped that 3-year event-free survival will be~     increased significantly when compared to Total Therapy II. Additionally, participants will~     have the option of providing biospecimens for a sub-study evaluating gene expression~     profiling at specific timepoints to better understand drug-resistance in myeloma, and to~     determine whether there are genes or gene products in the resistant population that can be~     targeted by novel therapies.~   "
115177|NCT01548560|"~     This is a study to determine the safety of dapivirine gel and dapvirine film for healthy,~     HIV-uninfected women aged 18-45 years using the product for 7 daily doses.~   "
115178|NCT01548547|"~     This study aims to compare the clinical efficacy of multimedia audiovisual training to hands~     on practice till perfect training for pediatric and emergency medicine residents'~     procedural skills. This initial study will explore the success rates on infant lumbar~     puncture and child intravenous access skills in post-graduate year one pediatric residents.~   "
115179|NCT01548534|"~     The aim of this study is to increase, by DHA-induced chemosensitization, the activity of~     anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a~     nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).~   "
115180|NCT01548521|"~     Background: Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder~     arising from the lack of expression of paternally inherited imprinted genes on chromosome~     15q11-q13. The syndrome includes severe neonatal hypotonia with impaired suckling leading to~     failure to thrive in the most severe cases, subsequently followed by an early onset of~     morbid obesity with insatiable hunger, combined with other endocrine dysfunction probably~     due to hypothalamic dysfunction. The pathophysiological mechanism of the occurrence of the 2~     main nutritional phases of PWS is unknown. A deficit in the oxytocin (OT)-producing neurons~     of the paraventricular nucleus in the brain of these patients has been reported. In addition~     of its well-known anorexigenic effect, OT is involved in establishing and maintaining social~     codes. Indeed, we have recently shown in a double blind placebo study, that OT~     administration to adult patients with PWS significantly decreased depressive mood tendencies~     and tantrums while increasing trust in others with some data on a trend to decrease appetite~     with higher satiety. Moreover in a PWS mouse model generated from a MAGEL2 KO gene a single~     OT injection at 5 hr of life prevent the early death observed in 50 % of the new born mice~     by recovering normal suckling. Interestingly this effect is no longer observed if OT~     injection takes place later. These data, OT deficit in PWS, good tolerance of OT and its~     effect after intranasal administration in adult patients with PWS and the recent striking~     data obtained in the MAGEL2 mouse model, prompted us to evaluate the tolerance of a single~     administration of intranasal OT in PWS newborns and its possible effect on suckling and food~     intake. Nowadays the diagnosis of PWS is done during the first months of life in our~     country. At this age, children still present with poor suckling suggesting that OT may be~     still efficient. Moreover in adult patients with PWS we have shown that OT improves some~     typical behavioral troubles. Therefore we first want to evaluate the tolerance of the~     intranasal administration of OT in 6 infants with PWS genetically confirmed and its effect~     on suckling, milk intake and weight gain.~   "
115181|NCT01548508|"~     The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation~     (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment~     could improve functional exercise capacity.~   "
115182|NCT01548495|"~     The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum~     patients who had an inadequate response or did not respond to Recombinant human~     erythropoietin (rHuEPO) treatment.~   "
115183|NCT01548482|"~     This phase I trial studies the side effects and the best dose of trebananib and temsirolimus~     when given together in treating patients with solid tumors that are metastatic or cannot be~     removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to~     the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving trebananib with temsirolimus may be an effective treatment~     for solid tumors.~   "
115185|NCT01548456|"~     This is a prospective observational study of patients with femur fractures in Dar es Salaam,~     Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open~     reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of~     reoperation for any reason, and the secondary outcomes are fracture healing, return to work,~     and health-related quality-of-life. The investigators hypothesize that there will be a~     difference in the rate of reoperation for patients with femur fractures treated with an IMN~     compared to ORIF with a plate.~   "
115186|NCT01548443|"~     The wound healing efficacy and safety of Medifoam H in patients with minor, acute trauma.~      The hypothesis of this study is that using Medifoam H dressing for a week is not inferior~     to using Duoderm THIN dressing in wound healing.~   "
115187|NCT01548430|"~     The purpose of the study is to examine the safety, tolerability, immunogenicity and~     pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive~     impairment.~   "
115188|NCT01548417|"~     The primary hypotheses under test are that alcohol dependent subjects treated with~     mifepristone will report decreased craving for alcohol following alcohol exposure in the~     laboratory and report significantly less drinking under naturalistic conditions, than those~     treated with placebo.~   "
115189|NCT01548404|"~     To assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668/SAR231893 in~     adult patients with moderate-to-severe atopic dermatitis (AD).~   "
115190|NCT01548391|"~     This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171~     in healthy male subjects.~   "
115191|NCT01548378|"~     The purpose of this study is to evaluate whether intramuscular injections of NL003 into the~     calf is safe and effective in the treatment of critical limb ischemia~   "
115192|NCT01548365|"~     The purpose of this study is to determine whether an infusion therapy nursing expert service~     is effective in decreasing hospital length of stay, improving the clinical results of venous~     access devices and increasing patient satisfaction with venous access.~   "
115193|NCT01548352|"~     Syncope is a major health problem. In the emergency department (ED), the management of~     patients with syncope still remains a clinical challenge because underlying diseases and~     prognosis can be extremely various. Structural heart disease and primary electrical~     disorders are major risk factors for sudden cardiac death and mortality in patients with~     syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease~     have an excellent prognosis.~      Therefore The investigators test the hypothesis that the use of a meticulous patient~     history, clinical examination and novel biomarkers can improve the rapid and accurate~     diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk~     stratification regarding adverse outcomes.~      The prospective multicenter cohort study is designed to enroll 720 patients presenting with~     transient loss of consciousness within the last 12 hours to the ED. Blood samples for the~     measurement of novel biomarkers will be obtained at presentation.~      All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse~     events (death, resuscitation, recurrence of syncope, hospitalization for syncope).~   "
115194|NCT01548339|"~     The purpose of this study is to compare the clinical outcomes of early versus delayed~     laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.~   "
115195|NCT01548326|"~     The purpose of this study is to determine whether short-term Atorvastatin can increase the~     immunity response to hepatitis B vaccination in vaccine Nonresponders.~   "
115196|NCT01548313|"~     The ideal food for normal infants is human milk. In addition, breast milk has been shown to~     be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they~     play a key role in the initiation and development of the gut microbiota. Intestinal~     colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and~     the homeostasis of the intestinal epithelium. Colonization begins immediately after birth,~     while later the composition of the gut microbiota is affected by feeding practices. Results~     of some studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the~     adhesion of probiotics to mucosal surfaces and along with probiotic bacteria contribute to~     the regulation of innate and adaptive immune responses and present a link among mother's~     diet, and microbes. The main purpose of the proposed research is to establish the link among~     mothers' nutrition, human milk LCPUFAs composition and microbiota and their potential~     influence on child's gut microbiota development. Pregnant women from three different regions~     of Slovenia will be involved into the study. Dietary intakes will be assessed during~     pregnancy, at the beginning of the 3rd trimester of pregnancy, and during lactation, at 4~     weeks post partum, by 7-day weighed dietary protocol (7DP). Human milk (colostrum, and~     mature human milk) and infant's faeces will be sampled twice: at 2 or 3rd day post partum~     (meconium) and at 4 weeks post partum for the determination of human milk LCPUFAs~     composition and the assessment of human milk (colostrum und mature) and faeces microbiota.~     The fatty acid composition of human milk will be analysed by capillary gas-liquid~     chromatography (GC). Microbiota of milk and faeces will be studied using conventional~     microbiological and modern molecular approach such as qualitative and quantitative PCR~     amplification of informative genomic regions, DGGE/TGGE and/or t-RFLP and sequencing.~     Regular monthly meetings with the researchers will be organised for discussion and advising.~     Basic health parameters of infants will be followed. Data will be gathered from maternity~     department medical charts, from regular paediatric health care visits and from especially~     designed health care diary each mother will keep until the end of her child's first year.~   "
115197|NCT01548300|"~     The investigators posit that a multi-national collaborative effort with focused~     investigations in environments with the highest levels of exposure (developing countries~     such as China and India), are likely to provide new and much needed data on the risk posed~     by these variables on an individuals life-time risk for type 2 diabetes and cardiovascular~     complications. The investigators will test this hypothesis through the establishment of a~     network that would lead studies on the links between exposure and adverse Chronic~     cardiometabolic effects and propose doing this in this as part of 3 specific aims.~   "
115198|NCT01548287|"~     This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease~     or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is~     to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.~   "
115199|NCT01548274|"~     The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial~     progenitor cells of patients with atherosclerosis.~   "
115268|NCT01547377|"~     The aim of this randomized double-blind study was to evaluate the effect of oral zinc and~     selenium supplementation on oxidative stress and inflammation biomarkers as well as the~     status of zinc and selenium in patients with atherosclerosis and angina stable treated with~     rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs~     zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and~     selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and~     anti-inflammatory as well as the status of minerals?~   "
115200|NCT01548261|"~     Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have~     good clinical results in treating patients with ocular surface disorders in both human and~     animal studies. However, such technique has not been well established in this hospital. The~     main purpose of this study is to obtain the discarded oral mucosal tissue from healthy~     donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal~     tissue will be cultured under different types (co-culture with or without 3T3~     cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14,~     Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin~     cell line co-culture system on cell condition. The investigators plan to start the study~     from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.~   "
115201|NCT01548248|"~     This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety~     of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and~     incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes~     treated with insulin NPH under normal clinical practice conditions in Slovakia.~   "
115202|NCT01548235|"~     This study is conducted in Europe. The aim of this study is to investigate safety and~     efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin~     aspart 30 (NovoMix® 30) treatment.~   "
115203|NCT01548222|"~     This is a trial to determine if patients who are well controlled and on basal insulin are~     treated with excessive basal dose.~   "
115204|NCT01548209|"~     Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine~     was reported to a reduced PONV due to opioid-sparing effect. It is not clear if~     dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study:~     intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than~     placebo for reducing of PONV and improve postoperative quality of recovery score within 48~     postoperative hours.~   "
115205|NCT01548196|"~     The purpose of the study is to assess and compare the efficacy and morbidity standard~     percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be~     enrolled. Patients will be randomized to one of four groups: standard percutaneous~     nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or~     ureteral stent/catheter. Primary Outcome Measures will include length of procedure and~     estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores,~     time to ambulation, time to oral intake, and pain scores will also be recorded. Time to~     nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge~     from the hospital will also be recorded. Incidence and type of post-operative complications~     will also be recorded.~   "
115206|NCT01548183|"~     The US preventative services task force (USPSTF) recommends behavioral counseling in the~     primary care setting for prevention of sexually transmitted diseases, however, screening and~     counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect~     behavior change in patients, but its effect on patients that report at-risk sexual behavior~     in the emergency department (ED) is unknown. The investigators seek to assess the~     feasibility of ED-based screening of young adult females for at-risk sexual behavior and~     enrolling them in a 3 month trial using TM to deliver information and skill building to~     improve health behavior.~   "
115207|NCT01548170|"~     Sunitinib is an ATP competitive tyrosine kinase inhibitor of several membrane receptors~     including VEGFR-1, -2, and -3, PDGFR-α and -β, c-KIT, CSF-1R, FLT-3, and RET. Through this~     molecular mode of action, sunitinib is able to avoid tumoral angiogenesis and proliferation.~     Sunitinib is already approved by the FDA, EMEA and AEMPS for the treatment of patients with~     metastatic renal cell carcinomas and those with metastatic gastrointestinal stromal tumors~     (GIST) with progression or intolerance to imatinib.~      Suntinib has recently reported to be superior than placebo in terms of response rate (9.3%~     vs. 0%; p<0.05), progression free survival (11.4 vs. 5,5 months; HR 0.41;p<0.05), and~     overall survival (HR 0.40;p<0.05) when administered in a phase 3 trial to patients with~     advanced pancreatic neuroendocrine tumors (NETs).~      Sunitinib is an expensive drug that drains the budget of health public system therefore it~     demands a rational drug use.~      Sunitinib is metabolized by CYP3A4, that belongs to the P450 cytochrome system in the liver.~     Most of the drug is eliminated in faeces and only 16% by urine. Sunitinib has no food-effect~     when taken with meals. Pharmacokinetics parameters did not differ between cancer patients~     and healthy volunteers.~      Houk et al. Showed that the area under the curve of plasmatic concentration of sunitinib and~     its active metabolite did correlate with clinical outcome. In other words, the higher plasma~     concentration area under the curve the highest rates of radiological response, progression~     free and overall survival rates.~      Ketoconazol is an antifungal drug that inhibits the CY3A4 inducing an elevation of peak~     plasma levels of other drugs administered simultaneously and that are metabolized by the~     same system. In the labeling sheet of sunitinib it is said that ketoconazol induced a 49%~     and 51% of increase of plasmatic sunitinib Cmax y AUC0-∞ when both drugs were administered~     together. This fact makes that the investigatorspropose that by administering both drugs~     simultaneously the investigators could reduce sunitinib dose by a lower metabolization with~     similar plasma concentration. The dose reduction would impact in drug cost.~      Here the investigators propose to determine the most optimal combination dose of sunitinib~     (25 mg or 37.5 mg) and ketoconazol (200mg o 400mg) by which the investigators could have~     plasmatic bioequivalent concentrations compared with single dose of sunitinib 50mg.~      Each volunteer will be assigned to a treatment arm (Arm A and Arm B). Volunteers included in~     Arm A will take: sunitinib 50 mg, sunitinib 37.5 mg + ketoconazole 200 mg and sunitinib 37.5~     mg + 400 mg ketoconazole. Volunteers included in Arm B will take: sunitinib 50 mg, sunitinib~     25 mg + ketoconazole 200 mg and sunitinib 25 mg + 400 mg ketoconazole~   "
115208|NCT01548157|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HCP1007 capsules and Rosuvastatin plus Omega-3.~   "
115209|NCT01548144|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed)~     or of the combination of 3 study drugs that can be given to patients with advanced cancer.~     The safety of these drug combinations will also be studied.~      Crizotinib is designed to block a protein called ALK, which is involved in cancer cell~     growth and survival.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Pemetrexed is designed to block proteins that may cause tumors to grow.~   "
115210|NCT01548131|"~     Site of research: Helsinki University Central Hospital (HUCH), Department of Obstetrics and~     Gynaecology and University of Helsinki Department of Psychology, in collaboration with~     Karolinska University Hospital in Stockholm, Sweden~      In Finland and in Sweden, fear of childbirth is one of the most common reasons for~     consultation of obstetrician, and for an elective caesarean section. Approximately 5 to 6%~     of pregnant women suffer from severe fear of childbirth, which disturbs family-life and~     working and prevents the preparation to normal childbirth and parenthood. It represents as~     nightmares, panic attacks, anxiety, and as numerous physical complaints. After giving birth~     it can be difficult for these women to form an early mother-infant-relationship. Their risk~     for puerperal depression is also increased.~      Finland and Sweden have both a long tradition in research of this field. In Finland, the~     investigators research group started the first out-patient clinic for fearful pregnant women~     in HUCH in1996. Different strategies how to treat fear of childbirth have been applied to~     clinical practise. Studies on the treatment for fear of childbirth are, however, scanty.~     Some descriptive studies have showed that far more than one half of patients can, after the~     treatment, prepare to a normal vaginal delivery and caesarean without a medical indication~     can be avoided. The aim of the treatment should be both to avoid unnecessary caesareans,~     increase the number of uneventful vaginal deliveries and to help the pregnant couple to~     prepare to parenthood, as well as to prevent puerperal depression.~      In this study, psychotherapeutic group psychoeducation is studied as promising treatment for~     severe fear of childbirth. To screen fear of childbirth, all women coming to ultrasound~     screening at the 18 to 20 gestational week in HUCH are asked to fill in a specific~     questionnaire. Those nulliparous women whose score for fear exceeds 95th percentile are~     randomized to intervention and to control group.~      The intervention group is invited to start a psychotherapeutic group therapy based on~     cognitive and psychodynamic therapy combined with training in relaxation. Each group~     consists of six nulliparous women and meets six times during pregnancy 120 minutes at a~     time. Between the sessions the patients fill in a homework questionnaire. One session~     focuses on the partner's role and the partners are present then. Three months after~     delivery, the groups meet once more.~      The women in the control group stay in the care of community midwives and general~     physicians. If needed, they are referred to out-patient clinic in the maternity hospital~     where their fear is treated according the clinical practice of that hospital, mainly support~     from obstetrician or midwife.~      The women and their partners in both groups are asked, approximately one month after the~     screening and one month before the due date of delivery, to fill in the questionnaires~     examining depression, self-esteem, general anxiety, social support, marital satisfaction,~     personal projects and concerns, and efficacy concerning childbirth and maternity. After~     childbirth, data about the childbirth will be collected. Three months and two years after~     childbirth mothers and fathers in both groups receive again a psychosocial questionnaires.~      The aim of the study is to help the authorities to organize the treatment for fear of~     childbirth in their districts by examining the benefits of the treatment also in long-run.~     The investigators hope the results would lead to production of Current Care guidelines for~     fear of childbirth.~   "
115211|NCT01548118|"~     This study will evaluate the safety of a novel recombinant human papillomavirus bivalent (~     types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45~     years of age at enrollment.~   "
115212|NCT01548105|"~     Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found~     to be associated with severe POP. The authors' proposed explanation was that smoking impairs~     tissue and wound healing. Our primary objective is to document whether smokers with pelvic~     organ prolapse (POP) are different from non-smokers with POP with respect to collagen~     biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.~   "
115213|NCT01548092|"~     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the~     treatment of recto-vaginal fistula.~   "
115214|NCT01548079|"~     In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric~     surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day~     before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as~     controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a~     complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and~     fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal~     stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will~     be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose~     tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1~     g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in~     liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for~     quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis,~     respectively, histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and~     measuring of hepatic and white adipose tissue (WAT) lipase activity. In all patients at~     randomization, abdominal ultrasound will be performed for the detection of NAFLD and~     gallstones and a blood sample will be taken for the analysis of polymorphisms of hepatic~     lipid synthesis, storage, fatty acid (FA) oxidation and export genes. Six month after~     operation, HOMA, OGTT and abdominal ultrasound will be repeated.~   "
115215|NCT01548066|"~     Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and~     regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at~     low level through regulation by GSK-3, multifunctional serine/threonin kinase. After~     phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore,~     inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce~     growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for~     decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been~     studied yet.~   "
115216|NCT01548053|"~     Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000~     individuals in Canada and the numbers of community dwelling older adults with AD is rapidly~     growing. AD is associated with over $15 billion annually in care costs. Most individuals~     with AD are under the care of primary care providers (PCPs) including family physicians and~     primary care nurses. The evaluation and management of AD is challenging for PCPs and the~     quality of care provided to older adults with AD by PCP could be improved which would~     optimize outcomes for this vulnerable population. Provision of quality care to older adults~     with AD involves implementation of best practices as outlined in guidelines such as the~     Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia.~     Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals~     affected by AD, this project will develop practical, clinically relevant resources for~     primary care physicians and nurses to aid in the evaluation of older adults with AD. A~     knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool)~     will be introduced into several primary care settings in Ontario using educational sessions~     with PCP with additional support from internet resource and a dementia care manager. The~     quality of dementia care provided to older adults newly diagnosed with AD will be assessed~     in the three years preceding the intervention compared to the year following the~     implementation. This project will also describe the process of knowledge exchange with PCPs,~     including potential barriers and facilitators of knowledge uptake and examine if the care~     provided during the intervention was patient-centred through interviews with patients and~     caregivers.~      Research Objectives:~        1. Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on~          best evidence;~        2. Transfer these knowledge tools into a variety of primary care settings in Ontario; and,~        3. Evaluate the effects of this intervention on dementia quality of care, PCP application~          of knowledge, and the patient-centeredness of care.~   "
115217|NCT01548040|"~     The study is a double-blind randomized controlled clinical trial.Approximately 118 patients~     (males and females) who are at least 40 years of age, who are scheduled for total-knee~     arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab~     XP and a standard rehabilitation program and 2) a control group who receive only a sham~     device and a standard rehabilitation program. Patients are tracked for measures of function,~     pain, quality of life, physical performance and acceptable states status at 6 weeks and 1~     week before surgery and 3, 6, 12, and 52 weeks following surgery.~      Hypothesis 1: The effect of 12-weeks of Kneehab XP (peri-operative NMES) combined with~     standard rehabilitation in patients undergoing TKA surgery will lead to increased quadriceps~     strength compared to a control group at the 6 week post-operative time point.~      Hypothesis 2: The effect of 12-weeks of Kneehab XP (peri-operative NMES) combined with~     standard rehabilitation in patients undergoing TKA surgery is better than the control group~     as measured by PASS at post-operative week 6. The investigators hypothesize that a~     significantly larger proportion of patients will indicate a positive PASS in the Kneehab XP~     group compared to the control group.~      Hypothesis 2:The investigators hypothesize that the mean change scores for pain, physical~     and functional performance measures will be significantly better for the Kneehab XP group at~     post operative week 6. Additionally, the investigators report the baseline corrected scores~     for these outcomes, as well as the primary and secondary outcomes, at all the other follow~     up time points.~   "
115218|NCT01548027|"~     The objective of this study to determine the effect of surgical transversus abdominis plane~     block and local infiltration for postoperative pain control in major abdominal surgery~     compare with control group.~   "
115219|NCT01548014|"~     The purpose was to evaluate as to whether administration of infliximab of 12 week interval~     with supplementary VSL#3 is more effective or at least of similar efficacy when compared to~     conventional administration of infliximab only of 8 week interval.~   "
115220|NCT01548001|"~     This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod~     in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid~     Arthritis (RA).~   "
115221|NCT01547988|"~     The purpose of this study was to evaluate the effect of a group-based functional and~     specific balance training program on balance function in healthy older adults. It is~     commonly considered difficult to improve balance function in healthy older adults. The~     program included dual-task exercises; physical training exercises and a cognitive task (e.g.~     reading or reciting a story) performed simultaneously, as well as perturbation exercises,~     where balance is challenged in unexpected ways.~      The investigators hypothesized that following the proposed training, older adults would~     improve their speed of taking a step in both single and dual task conditions, refine their~     ability to control balance when standing still and improve their self-reported physical~     function.~   "
115222|NCT01547975|"~     Currently, no demographic and surgical results comparing different donor cornea sources were~     available in Taiwan. National Taiwan University Hospital (NTUH), as one of the largest~     tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care~     for patients receiving corneal transplantation. With detailed medical record done of these~     patients during care in the ward and out-patient clinic, the investigators are competence~     for this meaningful program.~   "
115223|NCT01547962|"~     The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a~     free autogenous graft using donor tissue harvested from the subject's palate in the~     treatment of subjects who have an insufficient zone of attached gingiva associated with at~     least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between~     treatment and control in the change in amount of attached gingiva over the 6 month~     observation period.~      Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft~     will be placed in the other. The grafts will be evaluated clinically to determine the change~     in the amount of attached gingiva and on at least three subjects, a small biopsy will be~     taken to allow histologic evaluation and comparison of both grafts.~   "
115224|NCT01547949|"~     The purpose of this study is to assess the effects of tart cherry juice to reduce serum~     biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout~     of controlled eccentric exercise.~   "
115225|NCT01547936|"~     The purpose of this study is to evaluate the effect of the controlled adverse environment~     (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.~   "
115226|NCT01547923|"~     The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic~     screening of DPD deficiency for predicting toxicity to fluoropyrimidines.~   "
115227|NCT01547910|"~     The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with~     non-alcoholic fatty liver disease.~   "
115228|NCT01547897|"~     Primary objective:~      - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine~     ratio (ACR) in patients with type 2 diabetes and albuminuria~      Secondary objectives:~        -  To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)~        -  To evaluate the effect of study drug on markers of glycemic disorders, systemic~          inflammation, renal and liver disease and cardiovascular function~        -  To assess the safety and tolerability of study drug~        -  To determine the population pharmacokinetics (PK) of study drug~   "
115229|NCT01547884|"~     Background:~      - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is~     spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also~     cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and~     scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing~     elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may~     not be infected with filariasis. This study will look at the way that people with latent TB~     fight infection with these worms.~      Objectives:~      - To study how the immune systems of people with latent TB react to filarial infection.~      Eligibility:~      - Individuals between 18 and 65 years of age who have latent TB and may or may not have~     filarial infection.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide a blood and stool sample to test for infection.~        -  Participants who do not have lymphatic filariasis but have another kind of intestinal~          worm will be treated for the parasite. This will be their last study visit.~        -  Participants who have latent TB and lymphatic filariasis will be treated with the~          standard treatment for the disease. They will come back for a second visit 6 months~          later, and will provide another blood sample.~   "
115230|NCT01547871|"~     Background:~      - Spinal muscular atrophy type 1 (SMA 1) causes severe muscle weakness and problems with~     eating and breathing. The symptoms begin in infancy, and children affected with SMA 1 often~     die in early childhood. Researchers want to collect information on how SMA symptoms progress~     in first two years.~      Objectives:~      - To study how the symptoms of SMA 1 progress in infants and children.~      Eligibility:~      - Infants and children with SMA 1 born on or after January 1, 2007.~      Design:~        -  Researchers will review the child s medical records and talk with parents by telephone.~        -  For children who are under 2 years of age, the researchers will review the child s~          medical records and speak with you on telephone every 2-4 months. Phone calls with~          parents will take about 10 minutes and will involve questions about symptoms of SMA 1.~          Children will be followed until age 2.- Researchers are also interested in looking at~          medical records of children who are no longer alive or who are more than 2 years of~          age.~      Parents or children do not have to come to the NIH. They will provide consent to view these~     records, and information over the telephone.~      - No treatment or care will be provided as part of this study.~   "
115231|NCT01547858|"~     Background:~      - Formaldehyde has many uses in industry and medicine. However, exposure to formaldehyde has~     been associated with increased risk for myeloid leukemia. There are still questions about~     how the chemical reacts with bone marrow to increase this cancer risk. Some smaller studies~     have looked at how it affects stem cells, which are found in bone marrow. Researchers want~     to develop a much larger study of workers in China. The study will look at different levels~     of formaldehyde exposure. It will focus on how the chemical affects the blood cells and bone~     marrow.~      Objectives:~      - To study the effects of formaldehyde exposure on blood cells and bone marrow.~      Eligibility:~      - Individuals between 18 and 60 years of age who work in selected factories in Guangdong~     Province, China.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          be screened with a work history. Those who have been exposed to benzene, butadiene,~          styrene, or radiation will not be included.~        -  Participants will be studied based on their regular formaldehyde exposure level.~          One-third will be those exposed to more than 1 part per million (ppm) of the chemical.~          One-third will be those exposed to 0.3 to 1 ppm. A control group will have no exposure~          to formaldehyde or any other known toxic chemical.~        -  Participants will provide blood and cheek swab samples. They will also answer questions~          about their work habits.~        -  To look at chemical exposure levels, participants will wear a small monitor to work on~          3 different days. They may provide additional blood and cell samples as directed.~        -  No treatment will be provided as part of this study.~   "
115269|NCT01547364|"~     Objective: The purposes of the study are to~        1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W~          in comparison to normal saline.~        2. Determine if cumulative benefit results from caudal dextrose injection.~        3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow~          for blind injection of D5W.~   "
115232|NCT01547845|"~     Background:~      - Cancer and cancer treatments can cause symptoms and side effects. Pain, fatigue, and~     emotional distress are three common symptoms. Accurate reporting of these symptoms can~     improve treatment methods and outcomes. Even though symptom reporting is important to~     treatment, there is no method to collect and compare patient data from multiple cancer care~     centers. Researchers want to develop a method for collecting cancer patient symptom~     information from multiple centers. This method may help improve cancer treatment at~     hospitals and other care centers.~      Objectives:~      - To collect patient-reported symptom information from multiple cancer care centers.~      Eligibility:~        -  Individuals at least 21 years of age who were treated for breast or colon cancer in the~          past year.~        -  Participants will come from one of the participating cancer care centers.~      Design:~        -  Participants will answer a short questionnaire about their symptoms during cancer~          treatment. Questions will ask about symptom severity and experiences. Other questions~          will ask how well the doctors and nurses managed the symptoms.~        -  Participant responses will be compared with other medical and personal information.~          This information may include cancer type, age at diagnosis, and type of treatment.~        -  Treatment will not be provided as part of this study.~   "
115233|NCT01547832|"~     Background:~      - Early-onset Parkinson's disease (EOPD) is more likely to be caused by gene mutations than~     Parkinson's disease that develops in older people. Studying these mutations may help find~     therapies for EOPD. Researchers want to study mutations on a gene called PARK2. These~     mutations prevent fat uptake into cells and may interfere with normal brain function.~     Researchers want to study fat and cholesterol in the body to look at the effects of these~     mutations on the body and brain.~      Objectives:~      - To study connections between genetic mutations and EOPD.~      Eligibility:~        -  Individuals between 18 and 80 years of age with EOPD.~        -  Individuals between 18 and 80 years of age with no family history of Parkinson s~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  Participants will have some or all of the following tests:~        -  Blood samples and tissue (skin and fat) biopsies~        -  Cell line development from these tissue samples to study the function of PARK2~        -  DEXA scan to measure body fat context using low dose x-rays~        -  Glucose and insulin tolerance testing to measure blood sugar levels.~        -  Treatment will not be provided as part of this protocol....~   "
115234|NCT01547819|"~     Background:~      - Some people who have a traumatic brain injury (TBI) recover completely. Others, however,~     develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research~     suggests that levels of a brain chemical called GABA may differ in people with PTSD compared~     to those without PTSD. Researchers want to see if TBI can affect GABA in the brain and help~     develop PTSD. To look at the brain, researchers will use imaging studies with the chemical~     11C-Flumazenil, which will help the scan show GABA levels in the brain.~      Objectives:~      - To study the relationship between PTSD and TBI.~      Eligibility:~      The subjects will be recruited from the Walter Reed National Military Medical Center~     (WRNMMC).~        -  Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.~        -  Healthy individuals between 18 and 50 years of age who have no history TBI and no~          history of PTSD.~      Design:~        -  Participants will be screened with a physical exam and medical history. Urine and~          breath samples will also be collected.~        -  Participants will have two imaging studies, on the same day if possible. The first will~          be a magnetic resonance imaging scan to look at the brain. The second will be a~          positron emission tomography scan with the study chemical to look at GABA pathways in~          the brain.~   "
115235|NCT01547806|"~     Background:~      - One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by~     stem cell transplant. Researchers want to collect stem cells from the blood for later~     transplant.~      Objectives:~      - To collect stem cells for transplant as part of treatment for plasma cell myeloma.~      Eligibility:~      - Individuals at least 18 years of age who will have chemotherapy and stem cell transplant~     for plasma cell myeloma.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have filgrastim injections for 5 days before collection. This will~          move stem cells from the bone marrow to the blood.~        -  Participants will have apheresis to collect the stem cells.~        -  Participants who need additional apheresis procedures to collect stem cells will have~          filgrastim and a dose of plerixafor to improve the collection yield.~   "
115236|NCT01547793|"~     Background:~      - Some people with sickle cell disease have different health problems than others. This may~     be related to how easily and frequently the red blood cells break apart in the blood.~     Researchers want to test breath and blood samples from people with sickle cell disease to~     look for very small amounts of carbon monoxide, which is produced when red blood cells break~     apart. They will compare these results with breath samples from healthy volunteers. Studying~     different levels of carbon monoxide may help predict what health problems a person with~     sickle cell disease may get. It may also provide more information on possible treatments.~      Objectives:~      - To study breath carbon monoxide levels and their possible relation to the severity of~     sickle cell disease.~      Eligibility:~        -  Individuals at least 18 years of age with sickle cell disease.~        -  Healthy volunteers who are matched for age, sex, and race with the sickle cell disease~          group.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants with sickle cell disease will provide a blood sample and have a heart~          function test. They will also breathe into a bag to provide an exhaled breath sample.~        -  Healthy volunteers will provide an exhaled breath sample.~        -  No treatment or care will be provided as part of this study.~   "
115273|NCT01547312|"~     This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA)~     as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of~     Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C~     virus (HCV). The first segment, is a procedural pilot conducted prior to the main study,~     that is aimed at ensuring optimal execution of the FNA procedure. During the procedural~     pilot, core needle biopsy (CNB) will be performed on participants as part of their standard~     of care, but no study drugs will be administered, nor will any procedures other than FNA be~     conducted. The second segment, the main study, is designed to evaluate the feasibility of~     measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other~     additional procedures will be conducted.~   "
115237|NCT01547780|"~     Background:~      - People with traumatic brain injury (TBI) often have inflammation in the brain. A protein~     called the translocator protein (TSPO) is often present with inflammation. Researchers want~     to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and~     inflammation in the brain of people with TBI.~      Objectives:~      - To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic~     brain injury.~      Eligibility:~        -  Individuals at least 18 years of age who have had TBI and have had a brain scan that~          shows signs of inflammation.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  All participants will have two brain scans during an outpatient visit. A magnetic~          resonance imaging scan will study brain activity. A positron emission tomography (PET)~          scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.~        -  Participants with TBI will have two PET scans within 10 days of the head injury, and a~          PET scan around 90 days after the injury. They may also have MRI scans under this or~          another study. Tests of thinking, memory, and concentration will be used to study the~          effects of the injury and inflammation~   "
115238|NCT01547767|"~     Background:~      - A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that~     affects the muscles. Researchers collected clinical samples from people with this myopathy.~     More research is being done to develop a therapy for this disease. Researchers are asking~     for permission to study the samples already collected.~      Objectives:~      - To allow researchers to use clinical samples collected to study new treatments for ISCU~     myopathy.~      Eligibility:~      - People with ISCU myopathy who have provided clinical samples for study.~      Design:~        -  Participants will allow researchers to study clinical samples already collected. Blood,~          urine, muscle, and cell samples may be used. Medical records and photographs may also~          be studied.~        -  Treatment will not be provided as part of this study.~   "
115239|NCT01547754|"~     Background:~      - Some people with human immunodeficiency virus (HIV) develop problems with thinking and~     concentration when the virus affects the brain. This is known as mild neurocognitive~     disorder (MND). Research has shown that some HIV medications do not get through the blood~     brain barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood~     brain barrier. Differences in the activity of P-gp may help explain why some people with HIV~     develop MND. It is also possible that MND is partly due to inflammation in the brain.~     Researchers want to study P-gp and its effect on MND and HIV infection.~      Objectives:~      - To study P-gp and brain inflammation related to HIV infection.~      Eligibility:~        -  Individuals between 18 and 60 years of age who have HIV and either do or do not have~          MND.~        -  Healthy volunteers between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be collected.~        -  Participants will have one outpatient visit and one 3-day inpatient stay.~        -  At the outpatient visit, participants will provide blood samples and have a lumbar~          puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study.~        -  At the inpatient visit, participants will have two positron emission tomography (PET)~          scans of the brain. These scans will study brain activity and possible inflammation.~          One scan will involve a study drug called tariquidar, which blocks the activity of~          P-gp. A second lumbar puncture will be done before the first PET scan. Blood and urine~          samples will be collected daily.~   "
115240|NCT01547741|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast~     cancer cells, either by killing the cells or by stopping them from dividing. Giving the~     drugs in different combinations may kill more breast cancer cells. Giving combination~     chemotherapy after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This randomized phase III trial is studying different combination chemotherapy~     regimens and their side effects and comparing how well they work in treating women with~     non-metastatic breast cancer.~   "
115241|NCT01547728|"~     The objective of this study is to prospectively evaluate the response of recombinant~     antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to~     undergo cardiac surgery.~   "
115242|NCT01547715|"~     This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal~     ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.~   "
115243|NCT01547702|"~     The purpose of this study is to evaluate, by way of randomized controlled trial, the~     effectiveness of a web-based, time-flexible, and teacher-directed Teacher Help for ADHD~     program in reducing the impact of ADHD symptoms in elementary students.~   "
115244|NCT01547689|"~     The primary purpose of this study is to evaluate the safety and the tolerability of UC-MSC~     (Human Umbilical Cord-Derived Mesenchymal Stem Cell) .This study is also to investigate the~     efficacy of this treatment in patients with Alzheimer's disease (AD).~   "
115245|NCT01547676|"~     This randomized pilot trial studies clamped or unclamped surgery in treating patients with~     kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects~   "
115246|NCT01547663|"~     This study aims to test validity, reliability and practicality of translated NCS, CNPI and~     FLACC in unconscious patients in 48 hour following craniotomy.~   "
115270|NCT01547351|"~     This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in~     clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general~     neurology practices, or other academic or private practice settings) in the United States to~     assess the psychometric properties of the ARMS questionnaire in approximately 100 adult~     patients with MS who are experiencing a confirmed relapse, as identified by the investigator~     or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this~     study.~      The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on~     1 page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms~     affect daily activities and overall function, as well as patient's response to past~     treatments for previous relapses, as a means of guiding treatment selection. Part 2 is~     designed to evaluate treatment response in terms of symptom relief and functioning, as well~     as treatment tolerability. Part 1 of the survey is to be completed when the patient presents~     with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after~     initiation of treatment for relapse of MS. Treatment for relapse will be at the sole~     discretion of the investigator.~   "
115247|NCT01547650|"~     Rossi NF & Schrier RW reported that for having differential diagnosis in hyponatremic state,~     it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works~     showed that it is not easy to estimate the ECF state using by physical findings and by usual~     laboratory methods.~      Damaraju SC et al. first demonstrated that measuring central venous pressure (CVP) is~     significant to evaluate the ECF state in hyponatremic patients with intracranial diseases.~     Accordingly, it may be useful to measure the CVP in the hyponatremic patients. However,~     usually it is difficult to measure the CVP in all patients with hyponatremia because that~     the method is due to invasive procedure. With recently development, it is possible to~     estimate the CVP calculation using cardiac echogram without invasion. However, it is not~     clear that an evaluation by using such echogram estimates the state of ECF volume in~     hyponatremic patients.~      Therefore, the investigators examine whether the CVP calculation by using cardiac echogram~     by Marcelino P et al. method without invasion is estimated such condition in hyponatremic~     patients before and after treatments.~      As the primary endpoint, the VCI index values is investigated and compared with each group~     before and after correction of disorders of fluid with sodium. Furthermore, some variables~     including sodium, potassium, chloride, creatinine, BUN, uric acid, osmolality in blood and~     urine and plasma vasopressin are investigated and compared with each group before and after~     correction of disorders of fluid with sodium.~   "
115248|NCT01547637|"~     The key objective of this study is to compare success rates of ultrasound guided obturator~     nerve block and anatomic landmark guided obturator nerve block as determined by~     neuromonitoring endpoints and surgeon observations.~   "
115249|NCT01547624|"~     Today there is evidence for that neck specific exercises reduce neck pain problems in~     patients with mechanical neck pain. However, there is a lack of consensus on how to optimize~     neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine~     which and how muscles are activated in exercises thought to be neck-specific. There is~     neither enough knowledge of differences in neck muscle activation between patients with long~     standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle~     function improved with specific neck exercises. One approach would be a real time study of~     deformation and deformation rate in different layers of neck muscles in patients with~     residual long-term neck pain and disability after a whiplash trauma. The purpose of the~     present study was to investigate deformation and deformation rate in different layers of~     dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during~     rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion~     until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder~     elevation. Forty patients with long standing (more than 6 months but less than 3~     years)patients and 40 controls matched for age and gender will be included for comparisons~     between patients and healthy in neck muscle activation. The investigators also include 60~     patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific~     exercises in a 3 months period and B. will 30 be on a waiting list for 3 months.~     Measurements are performed at baseline and at 3 months follow-up. Those patients who~     fulfilled the 3 months period of neck specific exercises will also be asked for a 6 months~     follow-up.~   "
115250|NCT01547611|"~     Many patients with cervical disc disease have long-lasting and complex symptoms with chronic~     pain, low levels of physical and psychological function and sick-leave. Surgery on a few~     segmental levels might be expected to solve the disc-specific pain but not the non-specific~     neck pain and the patients'illness. As much as 2/3 of the patients have been reported to~     have remaining physical/ psychological disability long-term after surgery. A structured~     physiotherapy programme after surgery may improve patients'function and return to work. The~     main purpose of the study is to evaluate what a well structured rehabilitation program adds~     to the customary treatment after surgery for radiculopathy due to cervical disc disease in~     respect to function, disability, workability and cost effectiveness. The study is a~     prospective randomised controlled multi-centre study, with an independent and blinded~     investigator comparing two alternatives of rehabilitation. 200 patients in working age, with~     cervical disc disease with clinical findings and symptoms of cervical nerve root compression~     will be included after informed consent. After inclusion in the study patients will be~     randomised to one out of the two alternatives of physiotherapy, (A) customary treatment~     (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised~     and structured program of neck specific exercises combined with a behavioural approach plus~     customary treatment. Patients will be evaluated both clinically and with questionnaires~     before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main~     outcome variable are neck specific disability. Cost-effectiveness will be calculated. The~     inclusion will preliminary be closed 2012. The study could contribute to a better clinical~     decision making, a better health care which will reduce physical, mental and social costs~     for the patients, and improve the rates of patients returning to and staying at work.~   "
115251|NCT01547598|"~     This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost~     ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination~     ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution~     0.004%) monotherapy.~   "
115252|NCT01547585|"~     This study is being conducted to test the hypothesis that daily consumption of a baked food~     product containing whole soy for 6 weeks will significantly reduce plasma Low Density~     Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the~     overall goals of this study are to determine whether daily consumption of muffins made from~     whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether~     the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed~     chemical and physical characterization of certified defatted whole soy flour that will be~     incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin~     along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial~     in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a~     human clinical trial. All participants will be randomized into one of three groups and asked~     to eat two muffins daily for 6 weeks in the following combination: high dose soy; control~     group or low dose soy. Before, after, and mid-way during the feeding period, blood samples~     will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy~     phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI)~     and blood pressure will also be examined.~   "
115271|NCT01547338|"~     Current qualitative methods of assessing the aesthetic result following breast~     reconstruction are known to be poor.~      The investigators believe that real time digital video footage followed by expert panel~     review would be a superior method of qualitative assessment of breast cancer reconstruction~     aesthetics. This has never been studied before.~   "
115272|NCT01547325|"~     The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo~     Hydrogel on Dehisced Surgical Wounds.~   "
115274|NCT01547299|"~     The purpose of this study is to determine if enzalutamide is an effective therapy in~     treating localized prostate cancer prior to prostatectomy.~   "
115253|NCT01547572|"~     Since the introduction and favourable early results of enhanced recovery programmes more~     than a decade ago, such programmes have become increasingly popular following major surgery.~     Many elements of these programmes are based on solid evidence and derived from published~     trials. These programmes optimize different factors to reduce the stress of surgery with the~     aim of improving patient outcome and speed up recovery after surgery. Key factors prior to~     surgery are conditioning of expectations and optimizing associated disease. Strategies~     during the operation include use of short-acting anaesthetic (sleeping) agents, maintenance~     of normal temperatures and minimal access surgery (keyhole surgery).~      Care after surgery is optimized with appropriate analgesia (pain killers), early~     mobilisation (walking) and early feeding. This combined approach reduces hospital stay to~     2-4 days. There is also evidence that the improvements resulting from the implementation of~     an enhanced recovery programme do not cause significant deterioration in quality of life or~     transfer costs to another component of health care.~      The relative contribution of each of the single elements in the enhanced recovery programme~     remains uncertain. Good patient information gives confidence and improves overall outcome.~     No studies have examined the impact of video education on recovery.~      The aim of this study is to explore the use of video information provision for patients~     participating in an enhanced recovery programme.~   "
115254|NCT01547559|"~     We aim to evaluate the protective effects of eradication of HP and continue using~     Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to~     explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium~     in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.~   "
115255|NCT01547546|"~     This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and~     tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with~     progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the~     study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.~   "
115256|NCT01547533|"~     The investigators propose to study the transfer of benznidazole into breastmilk from the~     blood of lactating women who receive the drug for the treatment of Chagas disease.~     Breastmilk and blood samples will be obtained from these patients at given times after they~     take the clinically indicated medication, and the concentrations in both matrices will be~     compared to estimate degree of transfer, which in turn will be used to evaluate potential~     degree of exposure of infants breastfed by these women. This study will help clarify safety~     of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.~   "
115257|NCT01547520|"~     Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and~     analgesic effects, so its use may be helpful for patients receiving upper endoscopy.~   "
115258|NCT01547507|"~     The aim of this prospective, randomized study is to compare the performance, safety, and~     ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction~     System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26~     adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups~     to receive one of the following closed suction systems endotracheal tubes:~        1. AirWay Medix Closed Suction System~        2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared~          regarding the safety, performance and ease of use (usability).~   "
115259|NCT01547494|"~     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,~     vegan diet improves pain more effectively than a control supplement or a placebo. The~     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in~     migraines frequency. The study duration is 36 weeks.~   "
115260|NCT01547481|"~     This proposal is focused on developing a reliable, valid, and reproducible imaging~     techniques and statistical methodology for segregation of various forms of Parkinsonism from~     healthy adults without Parkinsonism.~   "
115261|NCT01547468|"~     The purpose of this study is compare the rates of post-operative delirium between a group of~     people receiving intravenous (IV) pain control after hip fracture surgery and a group of~     people receiving a femoral nerve catheter for pain control. Post-operative delirium is~     confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the~     group receiving the femoral nerve catheter for pain may have a lower incidence of delirium~     than the group receiveing IV pain medication.~   "
115262|NCT01547455|"~     Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative~     stress effects and stabilise plaque in some conditions. Some researches indicate loading~     dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers~     were significantly decreased. The investigators hypothesis loading dose atorvastatin may~     attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce~     postoperative acute kidney injury in cardiac surgery.~   "
115263|NCT01547442|"~     The purpose of this study is to determine the safety and effectiveness of the Artisan~     Aphakia Lens in the treatment of aphakia in children.~   "
115264|NCT01547429|"~     This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used~     as a secondary implant to correct aphakia in adults.~   "
115265|NCT01547416|"~     The aim of this study was to investigate whether robot assisted laparoscopic radical~     prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and~     whether combined general/epidural anesthesia could provide better postoperative~     diaphragmatic function.~   "
115266|NCT01547403|"~     The primary objective of the CUSTOM study is to respond to customer support issues (outside~     of the US) and to assess the impact of a particular treatment or perturbation relative to an~     initial control measurement. Sequential subject measurements will be analyzed to determine~     if a given action or condition induces a score shift, an inflation of measurement variance~     or elevated outlier rates.~   "
115267|NCT01547390|"~     This is a randomized controlled trial to estimate the efficacy of low dose aspirin for~     preventing preeclampsia in women identified as high risk. The investigators hypothesize that~     the risk of preeclampsia in women identified by a first trimester multiparameter predictive~     model to be at high risk will be significantly reduced by initiating low dose aspirin early~     in pregnancy.~   "
115297|NCT01547000|"~     The goal of this pilot study is to obtain preliminary information on the tolerability and~     efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette~     Disorder (TD, also called Tourette syndrome).~   "
115275|NCT01547286|"~     Asthma is a disease of rapidly increasing incidence that already affects more than 17~     million people in the United States alone. It has long been known that areas of severely~     reduced airflow occur in asthma and contribute significantly to the impairment of gas~     exchange in this disease. However, the extent to which local blood flow changes during an~     asthmatic attack is unclear. The purpose of this study is using PET-CT imaging to evaluate~     how the blood flow changes in the lungs during an asthma attack induced by allergens.~   "
115276|NCT01547273|"~     The purpose of this investigator-initiated study is to evaluate the facial gingival profile~     following immediate implant placement and provisionalization in conjunction with connective~     tissue graft with or without bone graft~   "
115277|NCT01547260|"~     The purpose of this study is to ascertain whether treatment with lenalidomide or~     lenalidomide in combination with gemcitabine induces modulation of immune effector functions~     and to characterize the nature of immune functions.~   "
115278|NCT01547247|"~     Water immersion insertion has been documented to decrease procedure-related discomfort~     during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten~     cecal intubation time. The investigators would like to assess whether combination of~     cap-fitted colonoscopy and water immersion insertion is feasible and safe method of~     diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators~     suppose that the use of cap is able to shorten it significantly. Patient comfort during~     colonoscope insertion, water consumption, length of the scope while reaching the cecum, need~     for external compression, need for positioning of the patient and endoscopist´s difficulty~     with colonoscopy are assessed.~   "
115279|NCT01547234|"~     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young~     adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men.~     The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive~     course.~      Several immunotherapies were developed in the last 10-15 years for the long term management~     of the relapsing type of disease. Treatment with these drugs decreases disease activity~     though cannot cure it.~      There are few treatments for targeting specific symptoms of MS, such as Provigil for the~     treatment of fatigue.~      Regarding problems related to spasticity and related gait problems , which is stated by over~     40 % of MS patients as their main complaint - present treatments include:~     non-pharmacological treatments such as physiotherapy, occupational therapy, hydrotherapy and~     pharmacological treatments such as Baclofen, Tizanidine and Botulinium toxin.~      Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This~     drug acts by blocking potassium ion channels and has been proven to improve walking in 35%~     of the patients after one month of treatment.~      The effect of Fampyra on hand function in MS has yet to be studied. The aim of this research~     project is to assess the effect of treatment with Fampyra on manual function of patients~     with MS. The investigators hypothesize that through the same mechanism by which Fampyra~     improves ambulation it can also improve manual function.~      MS patients visiting the MS center clinic at the Carmel Medical Center, with walking~     disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be~     offered to participate in this study. Participants who agree to participate will be asked to~     sign a written informed consent. Information regarding their personal and family medical~     history will be collected via questionnaires. Medical staff will fill clinical~     questionnaires detailing patient clinical status prior to the study.~      Patients will be followed up to 4 months after initiation of treatment with Fampyra.~     Compliance to treatment will be assessed by collection of the empty vials of the medication.~      In each of the follow-up meetings evaluation of manual function, evaluation of ambulation~     and evaluation of general neurological function will be performed.~   "
115280|NCT01547221|"~     Otomycosis is a superficial fungal infection of the external ear canal. Patients should be~     treated with cleaning fungal debris combined with topical antifungal agent. There is wide~     range of topical antifungal agents. However, there is still no consensus of the most~     effective topical antifungal agents in treatment otomycosis is still lacking.~      According to Thai National List of essential medicines for topical antifugal agents are:~        -  acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)~        -  boric acid (3% in isopropyl alcohol)~        -  gentian violet~        -  clotrimazole ear drop. But from literature review, there is no comparative study~          between boric acid and clotrimazole solution before.~      Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole~     solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.~   "
115281|NCT01547208|"~     The purpose of this study is to assess whether the burden of untreated non-sustained~     ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates~     with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if~     the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.~   "
115282|NCT01547195|"~     The recent scientific evidence shows that FM patients improve exercise capacity, symptoms~     and quality of life with the holding of regular exercise, especially aerobic exercise.~     Swimming is an aerobic workout of low impact, but no study has evaluated the effect of this~     activity in patients with fibromyalgia.~      Randomized controlled trial with blinded evaluator, which will be evaluated patients with~     fibromyalgia were divided into two groups.~      The intervention group will hold an exercise program of swimming (freestyle) and the other~     considered the control group held a walking program.~   "
115283|NCT01547182|"~     The aim is to study the effects of weight loss and weight loss combined with different types~     of physical activity on changes in physical functioning of older adults who are at-risk for~     cardiovascular disease.~   "
115284|NCT01547169|"~     The study will examine the effects of intranasally administered long-acting insulin detemir~     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment~     (aMCI). The rationale for these studies is derived from growing evidence that insulin~     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD~     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may~     have beneficial effects on brain function. Intranasal administration of insulin increases~     insulin signaling in brain without raising peripheral levels and causing hypoglycemia.~     Insulin detemir is an insulin analogue that may have better action in brain than other~     insulin formulations because of its albumin binding properties. The investigators will test~     the therapeutic effects of intranasally-administered insulin detemir in a dose-finding study~     in which participants will receive one of two doses of insulin detemir or placebo for a~     three week period. The investigators will test the hypothesis that either dose will improve~     memory and daily functioning in persons with AD/aMCI compared with placebo.~   "
115285|NCT01547156|"~     Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of~     diabetes and hypertensive patients by introducing a remote patient monitoring system~     supported with automatic patient decision support. The feedback system is coupled with~     back-office health coaching.~   "
115327|NCT01546597|"~     The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady~     state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).~   "
115286|NCT01547143|"~     The investigators would like to propose a pilot study evaluating the efficacy of etoposide~     combined with immunosuppressive agents for adult secondary hemophagocytic~     lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94~     or HLH-2004 protocol for childhood patients can improve the outcome and decrease the~     toxicities. The results of this pilot study will be a base of a more-improved phase-2~     protocol.~   "
115287|NCT01547130|"~     A quality colonoscopy examination remains as the gold standard for colorectal cancer~     screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in~     all cases that undergo the procedure. Currently, the most widely used cleansing methods~     employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large~     volume of PEG solution is required for it to be effective, and many patients refuse to drink~     a sufficient amount due to non-palatability. In this study, the investigators compare a~     novel colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based~     solution (HalfLytely) for large bowel cleansing.~   "
115288|NCT01547117|"~     Patients with POTS may not adequately expand their plasma volume in response to a~     high-sodium diet. Mechanisms involved in the regulation of plasma volume, such as the~     renin-angiotensin-aldosterone system and renal DA, may be impaired in POTS and may respond~     inappropriately to changes in dietary sodium.The purpose of this study is to determine (1)~     whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether~     plasma renin activity and aldosterone are modified appropriately by changes in dietary~     sodium in POTS; and (3) whether patients with POTS have improvements in their orthostatic~     tachycardia and symptoms as a result of a high dietary sodium level.~   "
115289|NCT01547104|"~     The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison~     to Glimepiride as add on therapy on several parameters characterizing postprandial~     metabolism and oxidative stress in type 2 diabetic patients on stable control with~     metformin.~   "
115290|NCT01547091|"~     Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic~     inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the~     destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis~     is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects~     and thus potentially alleviates the progression of rheumatoid arthritis. The study is to~     explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid~     arthritis.~   "
115291|NCT01547078|"~     A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in~     patients with liver disease.~   "
115292|NCT01547065|"~     The investigators hypothesize that transesophageal echocardiography is a valid method to~     obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a~     correlation between abnormal TEE resistive index measurements, intraoperative events and~     post-operative creatinine changes~   "
115293|NCT01547052|"~     I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children~     (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and~     60 children in the comparison condition).~      Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment~     attendance, treatment satisfaction, and any differences in these rates by groups.~      Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly~     greater treatment satisfaction rating by subjects, as well as by therapists and milieu~     staff.~      Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and~     externalizing symptoms.~      Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer~     internalizing and externalizing symptoms.~      Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation,~     risk taking, and social skills, and reducing depression.~      Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have~     significantly greater improvement in adaptive coping skills, emotion regulation, risk taking~     and impulsivity and social skills, and reducing depressive symptoms.~      Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.~      Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer~     critical incidents, including psychiatric hospitalization, emergency room visits, total~     number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual~     acting out, running away, stealing, police involvement, etc.~      II: Finalize therapist training manuals and educational materials to guide selection,~     training, and supervision of treatment providers.~   "
115294|NCT01547039|"~     The purpose of this study is to analyze the association between aspirin efficacy and general~     platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy~     (CEA).~   "
115295|NCT01547026|"~     Patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by~     weight gain. Sport programs have been shown to improve somatic and psychological health.~     However, the motivation to participate in sports therapy is usually impaired due to~     illness-related factors such as anhedonia and negative symptoms. Previous attempts to~     increase participation in sports therapy have used psycho-educational and behavioral~     attempts that require a lot of resources. In this study the investigators will use a brief~     method developed in experimental social psychology to build up implementation intentions.~     This method has been shown to improve psychological test performance in schizophrenia~     patients but has never been used in a clinical context.~      In two psychiatric hospitals, in-patients with schizophrenia who have been examined by a~     medical doctor, for whom any medical concerns for sports therapy participation have been~     excluded and who declared their motivation to participate in an existing standard sports~     exercise program will be recruited for the study. After information on the study and signing~     of an informed consent patients will be randomly assigned to two treatment conditions. In~     the control condition, the main therapist will individually deliver a 10-minute~     psycho-education on the helpfulness of sports to improve the health; this will be repeated~     in a shorter form in the regular individual treatment sessions over the following weeks. The~     intervention condition will use a structured procedure of the same duration to build up~     implementation intentions to participate in the sports therapy. The implementation~     intentions will briefly be repeated and updated in the following session.~      Primary outcome variables will be percentage of attended sport therapy sessions, persistence~     and compliance. Secondary outcome variables will be Body Mass Index. As confounding~     variables the investigators will assess amount of anti-psychotic medication in~     Chlorpromazine equivalents, negative and depressive symptoms, usual sport activities and~     cognitive impairments.~      The investigators expect that building up implementation intentions will increase~     participation, persistence and compliance of the patients in the sports and exercise therapy~     program compared to the patients who just have received psycho-education.~   "
115296|NCT01547013|"~     This is a study intended to evaluate a new device that uses light to measure the amount of~     oxygen in the muscles of injured and non-injured legs and forearms in specific situations.~     The name of this technology is NIRS (near-infrared spectroscopy). This is a prospective~     observational cohort study intended to gather data using NIRS among injured and noninjured~     extremities over time. Additionally, this data will help in establishing diagnostic~     perfusion value thresholds to be used in a subsequent interventional study confirming the~     efficacy of NIRS-based ACS monitoring.~   "
115298|NCT01546987|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid~     17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount~     of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor~     cells. This may be an effective treatment for prostate cancer when combined with hormone~     therapy. Studying quality-of-life in patients having cancer treatment may help identify the~     intermediate- and long-term effects of treatment on patients with prostate cancer.~      PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including~     TAK-700, together with radiation therapy in treating patients with prostate cancer.~   "
115299|NCT01546974|"~     The purpose of this study is to determine which humidification system is more effective in~     preventing pneumonia in mechanically ventilated patients. The study will compare a heat and~     moisture exchanger versus heated humidification.~   "
115300|NCT01546961|"~     For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body~     of evidence suggesting that pregnant women may require different doses of drugs, including~     antimalarials due to the physiological changes of pregnancy. It is important that any drug~     used in pregnant women it is given at the correct dose. The only way to evaluate this is by~     pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of~     chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same~     evaluation in the same woman post-partum is required as a control.~   "
115301|NCT01546948|"~     The primary aim of this randomized, double-blind study is to examine the effect of a single~     intraoperative dose of methadone on analgesic requirements during the first three days after~     hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a~     standard dose of the traditional intraoperative opioid (hydromorphone). Secondary outcome~     measures to be assessed will include postoperative pain scores and standard recovery~     variables such as hospital length of stay.~   "
115302|NCT01546935|"~     Currently, there is no treatment for children less than one year of age with influenza~     related lower respiratory tract infection that is either considered standard or registered~     in any country. This dismal scenario exists even though influenza related LRTI is a~     significant illness causing morbidity and mortality, especially in children less than 6~     months of age. Avian influenza has been reported rarely in children less than one.~      There are no data in Vietnam and very few data in Thailand on the burden of influenza in~     children less than one. This young age group suffers high mortality. Oseltamivir may be~     beneficial in such children. This is basis of this trial.~   "
115303|NCT01546922|"~     The aim of this study is to investigate whether a physiologically low hydrocortisone (HC)~     dose is better for cognition as compared to a physiologically high HC dose. In addition,~     quality of life, metabolic profile and somatosensation will be described in relation to HC~     dose.~   "
115304|NCT01546909|"~     PRIMARY OBJECTIVES~        -  To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or~          DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and~          poliovirus types 1, 2 and 3~        -  To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses~          against diphtheria, tetanus, and poliovirus types 1, 2 and 3~      SECONDARY OBJECTIVES~        -  To describe other parameters of the antibody persistence against diphtheria, tetanus~          and poliomyelitis antigens~        -  To describe other parameters of the immune responses to diphtheria, tetanus and~          poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE~        -  To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE~   "
115305|NCT01546896|"~     This research aims to investigate the efficacy and safety of buspirone in treating~     generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective~     effects using magnetic resonance imaging.~   "
115306|NCT01546883|"~     This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an~     anti-coagulant for a period of one year to see if there are any significant changes in the~     degree of left atrial structural remodeling in these patients. The investigators hypothesize~     that there will be a significant decrease in the degree of left atrial structural remodeling~     (fibrosis) in AF patients treated with dabigatran.~   "
115307|NCT01546870|"~     Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality~     in pediatric heart transplantation (PHT). Understanding the pathophysiology and early~     detection along with attempted medical management are crucial in preventing advancement of~     the disease and retransplantation or mortality. Coronary angiogram, although routinely used~     is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary~     flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and~     flow intracoronary wire may be more sensitive in evaluating the integrity of coronary~     vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge,~     measurement of these parameters has not been previously reported in PHT.~   "
115308|NCT01546857|"~     This study is being done to determine if a drug called gabapentin helps in the postoperative~     management of patients undergoing hip and knee operations. The investigators wish to~     determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a~     patient's pain and improve sleep, the patient will be better able to participate in their~     physical therapy. Gabapentin has already been shown to lessen postoperative pain when given~     before surgery. In healthy patients, it has also been shown to improve certain aspects of~     sleep. We hope to identify the effect of the drug, when given after surgery, on patients'~     pain and sleep.~   "
115309|NCT01546844|"~     This purpose of this is study is to evaluate the effectiveness of an interactive mobile~     health information service, Care4Life, in supporting patient self-management of Type II~     Diabetes Mellitus.~   "
115310|NCT01546818|"~     The purpose of this study is to examine the safety, tolerability, and immune response to~     killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected~     individuals.~   "
115311|NCT01546805|"~     The purpose of this study is to determine whether zinc supplements are effective in~     enhancing the treatment of oculofacial spasm disorders with botulinum toxin.~   "
115328|NCT01546571|"~     The purpose of this study is to determine how safe and how well POL-103A works in preventing~     the relapse of melanoma after patients who have undergone surgery.~   "
115329|NCT01546558|"~     The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on~     the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes~     mellitus (T2DM).~   "
115312|NCT01546792|"~     Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by~     interrupted breathing while sleeping. It is associated with cardiovascular problems such as~     high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are~     overweight and have impaired quality of life. Lifestyle interventions incorporating exercise~     training, dietary advice and behaviour change have been shown to elicit favourable changes~     in quality of life, body mass/composition and cardiovascular risk in a range of patient~     groups. However, no study has investigated the impact of lifestyle modification on such~     health outcomes in patients with OSAHS. This study will address this issue by investigating~     the effects of a lifestyle intervention on quality of life, body mass/composition and~     cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and~     randomly allocated to one of the two groups. Patients in the intervention group will be~     offered a 12-week individualised lifestyle programme consisting of supervised exercise~     training, dietary advice and behaviour change counselling. Patients in the control group~     will receive an educational booklet detailing healthy eating and exercise guidelines but no~     supervised or structured intervention. The results of this study will inform the design of a~     larger, multi-centre randomised controlled trial.~   "
115313|NCT01546779|"~     Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing~     strategies, to clear secretions from their lungs. Hand held devices may aid mucus~     expectoration, and also motivate the patient to manage by themselves. Our aims was to study~     if resistive expiration through volumetric incentive spirometer (VISex) can improve lung~     function in the short term in Cystic Fibrosis (CF) patients.~   "
115314|NCT01546766|"~     The basic objective of this project is to test a modification of existing technology for~     monitoring the responses of the pupil to light as a method for detecting regional losses of~     function of the retina. The instrument consists of a commercially available set of goggles~     that monitor the eye positions and pupils using infrared light and small cameras. The~     signals from the monitoring cameras are collected in a computer that records how their~     pupils have responded to each lighting condition. Because diabetics develop damage initially~     to certain parts of the retina before they have more serious damage, the ultimate goal of~     this research is to develop a simple, noninvasive, rapid method for widespread screening of~     diabetics in order to identify those who may require medical attention and/or therapy for~     diabetic retinopathy.~   "
115315|NCT01546753|"~     The purpose of this study is to determine if walnut oral immunotherapy can be used in~     subjects allergic to tree nuts to reduce tree nut allergy and induce changes in the~     subject's immune system.~   "
115316|NCT01546740|"~     there is a variety of glaucoma prevalence within different populations. this study examine~     the prevalence of glaucoma in the Arab population in Israel' as well as the demographic~     variables and the compliance to treatment in the population.~   "
115317|NCT01546727|"~     This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic~     and home family behavioral intervention (LAUNCH) against 1) motivational interviewing~     (attention control; MI) and 2) standard of care (true standard of care control; STC) with~     168 children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body~     mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH,~     MI) or standard of care. The primary end-point will be change in BMI z-score at the end of~     treatment. The investigators will also assess maintenance of treatment gains at 6 and 12~     months after treatment, and changes in factors thought to be mechanisms for change in weight~     (food intake and activity level), changes in the obesiogenic environment (parent weight,~     food intake and activity, and changes in the home food environment) and factors that could~     be negatively impacted (parent and child eating and feeding interactions).~   "
115318|NCT01546714|"~     The purpose of this study is to determine rates of sexually transmitted infections (STIs)~     among African American women who have sex with women (AAWSW). In addition, the study is~     interested in better understanding the types of risk behaviors that place AAWSW at risk for~     STIs. The investigators hypothesis is that AAWSW experience high rates of STIs, similar to~     heterosexual African American women. Knowledge gained from this study will guide development~     of interventions to reduce women's risk for these types of infections and will improve how~     AAWSW are screened for STIs.~   "
115319|NCT01546701|"~     The purpose of this study is to determine whether sublingual Buprenorphine is as effective~     as Iv Morphine sulfate on pain control of the patients with acute renal colic in the~     emergency department.~   "
115320|NCT01546688|"~     A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide~     arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will~     be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic~     (AEDs).~   "
115321|NCT01546675|"~     The purpose of this pilot study was to conduct a head-to-head comparison of two designs for~     transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket~     design hypothesized to provide greater skeletal stabilization. The investigators comparisons~     included assessments of patient comfort and satisfaction with fit, as well as dynamic~     kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel~     high-speed, high-resolution, bi-plane video radiography system.~   "
115322|NCT01546662|"~     The study will be conducted in two phases. First phase will be 16 weeks study to assess the~     safety, efficacy & to determine the most appropriate dose. Will consist of following visits.~      Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted~     to assess the sustained efficacy of the investigational product and accordingly the study~     will enter into phase II.~   "
115323|NCT01546649|"~     Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated~     against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with~     premenopausal breast cancer~   "
115324|NCT01546636|"~     The aim of this clinical investigation is to determine the effect of intraoperative~     ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder~     surgery in the beach chair position (BCP)~   "
115325|NCT01546623|"~     The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and~     efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously~     treated with hormonal therapy.~   "
115326|NCT01546610|"~     The present study aims to evaluate the effect of insoles for foot arthritis.~   "
115332|NCT01546519|"~     This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate~     the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies~     (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or~     for whom no standard therapy exists.~   "
115333|NCT01546506|"~     Rationale:~      Classical antiviral therapies target viral proteins and are consequently subject to~     resistance. To counteract this limitation, alternative strategies have been developed that~     target cellular factors. We hypothesized that such an approach could also be useful to~     identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral~     diversity and because of the need to develop therapies against unpredictable viruses as~     recently underlined by the H1N1 pandemic. Gene-expression signature-based screening~     identified broadly effective influenza A antivirals. Midodrine showed great results in~     inhibiting viral growth and was the most suited to confirm its efficacy in vivo.~      The main objective of the study is to assess the efficacy of midodrine taken at usual~     recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus~     Influenza A.~      Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3~     5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as~     the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of~     midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic~     of viral replication; analysis of the frequency of emergence of mutants and associated~     resistance.~      Methods:~      This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years~     infected by influenza A virus. Nasopharyngeal washing will be performed at day 0~     (randomization), 2, 3, 5 to show the viral replication evolution.~      161 patients will be randomized as follows :~        -  Arm 1 : Midodrine, 2.5 mg, 3 times a day~        -  Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon~          area.~   "
115334|NCT01546493|"~     Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause~     of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics~     and joint degradation to better identify 'at-risk' patients requiring corrective surgery~     will be scrutinized to gain a better understanding of the condition's natural history. The~     influence of certain morphologies (e.g. size and location of the deformity) will be analyzed~     to determine if this leads to aberrant loading of regions of the cartilage and subchondral~     bone, resulting in cartilage damage and joint degradation. Additionally, this research will~     determine if changes in the subchondral bone precede cartilage degeneration.~      The methodology for establishing the morphology/cartilage degeneration relationship includes~     Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer~     simulation/finite element analysis.~      The outcomes of this research may lead to a reduction in total hip replacement cases by as~     much as 70%, saving many Canadians from a painful and debilitating condition and reducing~     costs to the Canadian health care system by as much as $290 million annually.~   "
115335|NCT01546480|"~     Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to~     persisting inflammation.~      The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod~     at patients 12 months after the operation.~      DNA-samples are collected to examine genetical factors, important for perception of pain,~     and the development of chronic pain.~   "
115336|NCT01546467|"~     The purpose of the study is to investigate the effect of a 30 hour cognitive remediation~     program for young patients with early phase schizophrenia spectrum disorders on cognitive,~     clinical and functional outcome measures. The remediation program is integrated with~     whatever active rehabilitation the participant is currently attending (school, work, day~     program etc).~   "
115337|NCT01546454|"~     Women who have regular menstrual cycles have a lower risk of heart disease than men of the~     same age or women who no longer have menstrual cycles. The purpose of this study is to help~     determine why the menstrual cycle causes a lower risk of heart disease. The investigators~     believe that the hormones (estradiol and progesterone) produced during the menstrual cycle,~     as well as the normal processes occurring in the follicle and corpus luteum (transformed~     follicle), change levels of good and bad cholesterol in the blood-stream. These levels~     of good and bad cholesterol are an important risk factor for heart disease. Therefore, our~     goal is to determine what effects each of these factors (estradiol, progesterone, follicle,~     corpus luteum) have on the levels of good and bad cholesterol in the woman's bloodstream. As~     many women take birth control pills, which contain synthetic forms of estradiol and~     progesterone that block ovulation and development of a corpus luteum, the investigators also~     want to determine what effect one common type of birth control pill has on levels of good~     and bad cholesterol.~   "
115338|NCT01546441|"~     The IMPACT Plus Integrated Complex Care Clinic will create a team model of simultaneous~     interprofessional consultation and planning that brings together patients with complex or~     multiple chronic diseases, significant others/caregivers, the primary care team, community~     care providers and, uniquely, secondary consultation in real time at the primary care site.~     The purpose of this study is to evaluate whether the IMPACT clinic will reduce admission to~     hospital and visits to the emergency department (ED) in comparison to a control (usual care)~     group during a one year period of observation. Chart audits will be conducted on a monthly~     basis to calculate patients' complexity scores and data on all health services provided~     during the intervention phase, and compared between the intervention and control group.~     Additionally, surveys and semi-structured interviews aimed to measure patient, caregiver,~     and healthcare professional satisfaction of the IMPACT+ prior to and after initial~     assessment will be collected.~   "
115339|NCT01546428|"~     INC280 will be administered to Japanese patients with advanced soid tumors whose disease has~     progressed despite standard therapy or for whom no standard therapy exists. The trial will~     assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280~   "
115340|NCT01546415|"~     The study is designed to collect safety and efficacy of Desferasirox in Chinese patients~     with Iron Overload and Aplastic Anemia.~   "
115380|NCT01545882|"~     This study is being offered to patients who have hormone resistant prostate cancer (HRPC).~     This means that their prostate cancer is no longer responding to standard hormonal therapy.~      The purpose of this study is to determine whether Degarelix will be able to stop the PSA~     from rising in patients with hormone resistant prostate cancer.~   "
115341|NCT01546402|"~     This study is undertaken to determine the effect of intravitreal long acting dexamethasone~     implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic~     macular edema.~      Diabetic Macular Edema and cataract constitute important causes of visual impairment in~     patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated~     with progression of retinopathy.~      Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase~     inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with~     internal limiting membrane peeling have been tried for managing inflammatory cystoid macular~     edema.~      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to~     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular~     edema in patients who receive intravitreal TA is a major concern as the patients need~     multiple repeat injections.~      In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug~     Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was~     recently developed. Promising results have been shown in certain patients with persistent~     diabetic macular edema receiving this intravitreal drug delivery system with improvement in~     visual acuity~      The present study introduces a novel concept of using intraoperative Ozurdex ® implant in~     patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening~     of diabetic maculopathy.~   "
115342|NCT01546389|"~     This study will randomize 30 healthy adult participants to one of three cohorts comprised of~     six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID~     route. The goal will be to determine the optimal dose required to achieve 100% infectivity~     (ID100) of adult volunteers with P. falciparum malaria.~   "
115343|NCT01546376|"~     Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT~     and last weeks of RT .~   "
115344|NCT01546363|"~     The purpose of this study is to measure the levels of serum proteins and other biomarkers in~     cervical cancer patients. We believe that some of these markers may be useful in selecting~     patients for specific types of cancer therapies. These markers may also help to predict~     response to therapy, relapse after therapy, and survival after therapy.~   "
115345|NCT01546350|"~     The investigators propose to perform a clinical randomized trial to evaluate the effect of~     single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete~     chromosome complement of the blastocyst in comparison to standard ART methods in which one~     or more embryo are replaced. Patients will be randomized into two groups:~        -  Control group: patients will have up to two embryos replaced on day 5 based on~          morphological and developmental characteristics, and the other embryos reaching~          blastocyst stage will be vitrified. If patients in the control group do not have a~          pregnancy to term from that fresh cycle, they will be offered free PGD either for the~          frozen embryos of that cycle or for the next cycle (up to the center and patient). Data~          from that PGD is not part of the study.~        -  Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on~          day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any~          morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but~          vitrified for use in a future cycle.~   "
115346|NCT01546337|"~     Anemia is common among cancer patients and the treatment of choice is now~     Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to~     treatment. The purpose of this study is to evaluate the predictive value of endogenous~     erythropoietin rate on the response to erythropoietin beta. First, by confirming the~     predictive value of endogenous erythropoietin observed / predicted ratio on this response.~     Then if it is confirmed by establishing the optimal value of this ratio.~   "
115347|NCT01546324|"~     The purpose of this study is to collect blood samples from pregnant women who achieved~     pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy~     screening (with or without single gene gene testing). These samples will be used for test~     development of non-invasive prenatal diagnostic testing.~   "
115348|NCT01546311|"~     The primary objective of this study is to assess the effectiveness of the pro-active dynamic~     socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees~     during ambulation and rest, addressing residual limb volume fluctuations with a controlled~     flow bladder system.~   "
115349|NCT01546298|"~     This study hopes to improve the investigators understanding of how the immune system acts in~     allergic contact dermatitis. In order to reach this goal, normal volunteers, who are~     suspected of having allergic contact dermatitis, will be patch tested for the fifteen most~     common allergens. Then, biopsies will be taken of the skin at the sites where the there is a~     positive reaction to the allergen. Also, small biopsies will be taken from an area that~     received a patch but no allergen and an area that did not receive a patch to serve as~     controls. In a second stage of the study, volunteers will receive patches with the allergen~     to which they demonstrated an allergic response. More biopsies will be taken, over three~     designated time points. The biopsied skin samples will then be studied in a laboratory.~   "
115350|NCT01546285|"~     The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient~     Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.~   "
115351|NCT01546272|"~     A surgery made by an external incision requires to stitch the subcutaneous plans, usually~     performed using absorbable synthetic sutures hold on wire needle. This national,~     prospective, multicentric, and randomized study is devoted to estimate a technique of suture~     of the subcutaneous plans based on an implantable medical device delivering automatically~     absorbable staples. This particularly innovative technique lets to expect a tolerance and an~     efficiency at least equivalent to the reference technique (main objective). Moreover, this~     technique allows to anticipate a reduction of the duration of surgical procedure and~     anesthetic time while limiting the risks of blood wounds of the medical staff.The medical~     economic part of this study will check, from the point of view of the health care hospital,~     wether the technique is likely to reduce the costs and time consuming theater room~     procedures.~   "
115394|NCT01545700|"~     The question of a possible hyperglycemic effect from single-dose dexamethasone is an~     important issue for clinicians managing patients in the intraoperative and postoperative~     periods. Recent evidence suggests that even moderate elevations in blood glucose levels may~     be associated with adverse events.~      The aim of this clinical investigation is to determine whether standard clinical doses of~     dexamethasone produce hyperglycemia in the perioperative period.~   "
115352|NCT01546259|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Female gender and low-body mass index (BMI) is independently associated with incomplete~     colonoscopy, respectively. The investigators postulate that low-BMI female patients may~     benefit from using the water method for colonoscopy. In this proposal the investigators test~     the hypothesis that compared with conventional air insufflations the water method with water~     exchange significantly enhances the success rate of cecal intubation in low-BMI female~     patients.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in low-BMI female patients. The primary outcome is cecal~     intubation success rate. The secondary outcomes include cecal intubation time, maximum pain~     score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.~   "
115353|NCT01546246|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Colonoscopy has been considered the gold standard procedure in screening for colorectal~     disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult~     anatomy and prior abdominal or pelvic surgery. The investigators postulate that these~     patients may benefit from using the water method for colonoscopy. In this proposal the~     investigators test the hypothesis that compared with conventional air insufflations the~     water method with water exchange significantly enhances the success rate of cecal intubation~     in patients with immediately failed colonoscopy.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in patients with incomplete colonoscopy. The primary outcome is~     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum~     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection~     rate.~   "
115354|NCT01546233|"~     The purpose of this study is to compare the fatigue in lung cancer patients receiving~     chemotherapy treatment, between the education programme in self-care a multidisciplinary~     with the group who received standard care.~   "
115355|NCT01546220|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Older age is independently associated with incomplete colonoscopy, the investigators~     postulate that these patients may benefit from using the water method for colonoscopy. In~     this proposal the investigators test the hypothesis that compared with conventional air~     insufflations the water method with water exchange significantly enhances the success rate~     of cecal intubation in elder patients.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in elder patients. The primary outcome is cecal intubation~     success rate. The secondary outcomes include cecal intubation time, maximum pain score~     during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.~   "
115356|NCT01546207|"~     The goal of this trial is to test the impact of a step-wise approach for catheter ablation~     of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom~     chambers of the heart), in patients with a previous heart attack for whom catheter ablation~     is clinically indicated.~   "
115357|NCT01546194|"~     In most current academic anesthesia groups, it appears that consent for research is acquired~     on the day of surgery. This practice raises concerns because the hospital may be regarded as~     a coercive environment and there may be the possibility that the immediate preoperative~     environment prohibits adequate time for understanding the research project and making an~     informed decision about participation. However, this is often the only opportunity for~     anesthesiologists to obtain research consent. The aim of the present investigation is to~     utilize a survey study to determine if patients at Evanston Hospital are comfortable~     consenting for research on the day of surgery~   "
115358|NCT01546181|"~     Using an adaptive optics imaging device, retinal structures are observed in healthy and~     diseased subjects.~   "
115359|NCT01546168|"~     In this randomized double-blind study, the investigators would like to compare standard~     practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal~     deviation during AF ablation. The investigators hypothesize that the strategy of esophageal~     deviation will result in safer ablation strategy with a reduction in the incidence of~     esophageal injury as assessed by endoscopy.~   "
115360|NCT01546155|"~     Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain~     will alter the binding properties of ([11C]diprenorphine), a molecule that can be used~     during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance~     (fMRI) imaging will be used in this study.~   "
115361|NCT01546142|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
115440|NCT01544127|"~     The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing~     to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically~     hospitalized Veterans at high risk for suicide.~   "
115441|NCT01544114|"~     A 6 month study of VIMOVO in adolescents aged 12-16 years with juvenile idiopathic Arthritis~     (JIA)~   "
115362|NCT01546129|"~     Perineal massage at the end of labor stage 2 has been investigated in 2 randomized~     controlled trials using a water soluble lubricant. In one trial a significant reduction of~     labor stage 2 has been found, both trials did not show a significant increase of perineum~     integrity.~      In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a~     significant increase of perineal integrity have been shown. No adverse events have been~     reported.~      (see also Obstetric gel shortens second stage of labor and prevents perineal trauma in~     nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi~     M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135).~      Today's practice- Lubricants are widely used to enable manual vaginal examination during~     labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor~     stage 2 to protect the perineum. It has been shown for the first time that the use of the~     Dianatal Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been~     introduced to the EU markets in 2008.~   "
115363|NCT01546116|"~     -  Entecavir has been one of the option for treatment of lamivudine resistant chronic~          hepatitis B (CHB).~        -  In case of entecavir resistance, adefovir could be used. However, sequential~          monotherapy may result in multidrug resistance.~        -  It is thought that adefovir and lamivudine combination therapy reduce the risk of~          adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B~          virus (HBV) DNA to be undetectable in patients with entecavir resistance.~        -  This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy~          in CHB patients with entecavir resistance.~   "
115364|NCT01546103|"~     The purpose of this research study is to determine whether taking vitamin D, every day, over~     a 12 week period will improve the vitamin D status, risks for poor heart health, risks for~     developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers~     with low vitamin D levels.~   "
115365|NCT01546090|"~     The purpose of this prospective, randomized, double-blind, placebo-controlled study is to~     evaluate the effect of preoperative administration of alprazolam on the success of the IAN~     block for teeth with irreversible pulpitis.~   "
115366|NCT01546077|"~     The purpose of this study is to assess the efficacy of the hydrolocalization technique for~     placement of popliteal perineural catheters in comparison with the stimulating catheters. A~     non inferiority trial.~   "
115367|NCT01546064|"~     The purpose of this study was to compare the incidence and severity of biliary complications~     due to liver transplantation after choledochocholedochostomy with or without a T-tube. A~     per-protocol analysis was designed for recipients of orthotopic liver transplantation in a~     single center, who were randomly assigned to choledochocholedochostomy with or without a~     T-tube. It is a prospective and randomized study.~   "
115368|NCT01546051|"~     This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its~     metabolite BCI-632 and several new pro-drugs in healthy male subjects.~   "
115369|NCT01546038|"~     This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute~     Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents~     used to treat these diseases.~   "
115370|NCT01546025|"~     This is a 2-year research project to test the efficacy of brief motivational intervention~     for reducing heavy alcohol use in young adults transitioning out of high school.~     Participation occurs within 3 months prior to graduation or within 1 year following~     graduation or dropout from high school. Heavy drinkers ages 17-20 will be randomly assigned~     to receive one session of BMI or one session of relaxation training. All participants~     complete identical assessments at baseline and immediately post-intervention (during session~     1). Participants also complete in-person 6-week and 3-month follow up assessments to~     evaluate intervention effects. Study aims involve: a) testing the comparative efficacy of~     BMI; b) identifying moderators (person-level predictors) of intervention response; and c)~     identifying mediators (mechanisms) of intervention effects, that is, how BMI exerts its~     effect on outcomes.~   "
115371|NCT01546012|"~     Assess the patient feeling about the handiness of two different vials used to deliver both,~     unpreserved hyaluronic eye drops.~   "
115372|NCT01545999|"~     The purpose of this study is to~        1. assess the effect of PAS in schizophrenia in the dorsolateral prefrontal cortex (DLPFC)~        2. assess the effect of PAS induced long-term potentiation (LTP) on the performance of~          patients with schizophrenia on a cognitive task related to DLFPC.~   "
115373|NCT01545986|"~     The purpose of this study was to compare the effects of two exercise programs, using low~     velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have~     undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals~     performing HV exercise, compared to LV, would exhibit superior outcomes.~   "
115374|NCT01545973|"~     The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and~     sweat gland density on Scanning Kelvin Probe measurements.~   "
115375|NCT01545960|"~     The purpose of this study is to characterize the surface electrical potential of acupuncture~     points with a Scanning Kelvin Probe.~   "
115376|NCT01545947|"~     The main purpose of this first study combining an investigational dual mTOR inhibitor,~     CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to~     establish a maximum tolerated dose level for each combination in order to evaluate their~     effects in future clinical trials for advanced non-small cell lung cancer.~   "
115377|NCT01545934|"~     The purpose of this study is to study the effects of a multicomponent lifestyle intervention~     that includes partial meal replacements as a means to prevent excessive gestational weight~     gain in obese women. The primary hypothesis is that the intervention will reduce the rate of~     gestational weight gain compared with standard care.~   "
115378|NCT01545921|"~     The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated~     to the end of life for French cancer patients.~   "
115379|NCT01545908|"~     Ulcerative colitis is a condition that mainly affects young adults where the lining of the~     bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and~     treatments remain imperfect with no cure for the disease. Initial success has been shown~     with a highly novel treatment where patients with active ulcerative colitis receive a fecal~     enema to try and replace their stool containing bacteria that may be driving their disease~     with that from a healthy donor. To assess if this works by comparing how well it treats the~     disease compared to a placebo enema.~   "
115381|NCT01545869|"~     Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and~     sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a~     fair complexion patient, but may be present in other skin types.~      The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles,~     pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid~     1990s. The traditional CO2 laser was very effective, however it fell out of favor because it~     required general anesthesia. It also had a prolonged recovery time. Over the last several~     years, advances in technology known as fractional resurfacing has made the CO2 laser popular~     again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It~     proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of~     our knowledge, based on a thorough search of literature, no clinical studies assessing~     fractional CO2 laser in treatment of freckles could be retrieved.~   "
115382|NCT01545856|"~     Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The~     background incidence rate of CV events in a levodopa-treated PD population was assessed to~     better understand these comorbidities in the PD population. One objective of the study is to~     identify a population of prevalent PD patients with incident levodopa use within the years~     2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second~     objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and~     12-18 months after first prescription of levodopa among all new levodopa users.~   "
115383|NCT01545843|"~     The purpose of the study is to determine whether changing sleep patterns improves response~     to an antidepressant medication.~   "
115384|NCT01545830|"~     Vitamin D deficiency is widespread and appears to represent one easily and inexpensively~     modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data~     link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2~     diabetes and increased cardiovascular risk.~      Screening for vitamin D deficiency followed by supplementation in appropriate individuals~     could be among the simplest and most cost-effective measures for reducing metabolic syndrome~     and insulin resistance in the general population.~      This study will test the hypothesis that increasing vitamin D status in vitamin D deficient~     individuals with metabolic syndrome will:~        1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular~          disease,~        2. stabilize or reverse the stage of pre-diabetes,~        3. improve quality of life, and,~        4. improve the ability to make health-related behavioral changes.~   "
115385|NCT01545817|"~     Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by~     second-line everolimus in metastatic and advanced renal cell carcinoma~   "
115386|NCT01545804|"~     This is a single-arm, open-label phase II trial. Eligible patients must have histological or~     clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable~     to loco-regional therapy, documented progression with or intolerance to sorafenib-based~     treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.~   "
115387|NCT01545791|"~     This study is conducted in Europe. The aim of the study is to observe the safety of insulin~     detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.~   "
115388|NCT01545778|"~     The purpose of this study is to compare the risk of shopping behavior of tapentadol~     immediate release with the risk of shopping behavior of oxycodone immediate release.~   "
115389|NCT01545765|"~     The purpose of this study is to evaluate the duration of anesthetic effect produced ,~     Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the~     face and thigh.~   "
115390|NCT01545752|"~     Using different methods of electronic learning has been increasingly developed by emerging~     electronic educational technologies. They could apply on the net, CDs, Mobile, etc in~     different usage alternatives: interactive and non-interactive both in online and off-line~     approaches. In this educational trial, the interactive and non-interactive CD-based method~     for teaching medical terminology to nursing students of MUMS school of nursing and Midwifery~     during 2009-2012 was compared.~   "
115391|NCT01545739|"~     The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac~     resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and~     efficacy of these pacemakers. In particular, the left ventricular (LV) capture control~     feature is evaluated, which automatically measures the LV pacing threshold and subsequently~     adjusts the pacing output.~   "
115392|NCT01545726|"~     This study will assess the safety and efficacy of QAW039 when added to current therapy in~     patients that have sputum eosinophilia and persistent asthma.~   "
115393|NCT01545713|"~     Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation.~     The main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the~     donor HLA antigens. Additional potential targets are antibodies against MIC-A antigens or~     antibodies against targets expressed on the donor endothelial cells.~      Until recently, no specific means were available to test for the presence of donor-specific~     endothelial cell antibodies. The newly introduced XM-One AbSorber® assay allows isolating~     precursor endothelial cells from donor peripheral blood, and thus assessing the presence of~     donor-specific endothelial cell antibodies.~      XM-One AbSorber® is an in-vitro assay that allows for the specific enrichment of precursor~     endothelial cells which in turn promotes endothelial cells specific cross match testing.~      This assay is currently being used in an on-going Northwestern University (NU) research~     study (STU#00029988). The preliminary results of this study indicate that indeed some of the~     patients test positive against their respective donors. One potential explanation for this~     observation, that was not previously entertained, is that the antibodies causing the~     positive cross match response are actually of autoimmune nature. In order to rule-out such a~     potential explanation the investigators would like to further test these patients by~     performing an autologous XM-One AbSorber® assay in which the recipient sera will be~     incubated with the patients' own cells (as opposed to the respective donor cells in the~     parental study). This information is crucial for proper analysis of the data obtained in the~     NU STU#00029988 study.~   "
115444|NCT01544075|"~     With the present study the investigators wish to examine if reconceptualisation of pain, by~     educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of~     pain, in combination with psychologic innoculation is able to influence maladaptive (pain)~     cognitions, pain (inhibition) and movement performance, and reduce symptoms.~   "
115395|NCT01545687|"~     RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth~     sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve~     the quality of life of patients with head and neck cancer.~      PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral~     mucositis in patients with head and neck cancer who are being treated with cisplatin and~     radiation therapy. These results will be compared to results in patients using placebo~     lozenges.~   "
115396|NCT01545674|"~     This prospective blinded study will assess the diagnostic capability of an informatics~     enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying~     a fetus with an aneuploidy from fee floating DNA in the maternal blood.~   "
115397|NCT01545661|"~     This study will investigate the benefit of using Sputum induction for TB diagnosis in a~     primary care clinic for adult TB suspects that are either unable to produce a sputum sample~     (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO~     standard for frontline TB diagnosis). The investigators hypothesize that acquiring an~     induced sputum sample for smear microscopy and liquid TB culture will decrease~     time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce TB~     patients in a primary care clinic in a resource-limited high TB HIV prevalent setting.~   "
115398|NCT01545648|"~     The purpose of this study is to see whether taking denosumab for 12 months in women with a~     significant number of disseminated tumor cells in the bone marrow can reduce the number of~     these cells below a significant level.~   "
115399|NCT01545635|"~     Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University~     Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage~     will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and~     subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient~     meets the inclusion criteria (T1) and is recruited for the study, a first study related~     blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be~     randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or~     FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive~     fresh frozen plasma (FFP),respectively.~      Treatment failure will be registered if bleeding persists and ROTEM parameters do not~     improve after two times dosages of study drug. In these cases haemostatic rescue therapy~     will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will~     be administered to patients randomized to receive FFP and FFP will be administered to~     patients of the CFC group.~      In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse~     bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII~     concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy~     will be documented and a ROTEM will be performed thereafter.~      At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study~     related blood samples are drawn (40mL each).~      The indications for transfusion of red blood cells or platelets, administration of~     antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement~     are similar for both groups and treatment is performed according to clinical routine.~      Besides coagulation management during ED treatment until 24h on ICU, patient's care is not~     influenced by the study and follows clinical routine.~   "
115400|NCT01545622|"~     The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear~     radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more~     prone to making a definitive diagnosis based on a given scan than a nuclear radiologist.~     Accuracy of localization of the two groups will be analyzed. A secure website has been~     designed to which the physician will be able to login and view and rate the quality of each~     image and make a localizing diagnosis. Once they are finished, they will not be able to make~     any more changes, and their responses will be compared to the responses of their colleagues.~     The results will be analyzed to find if there is a significant variation in the ratings~     between the surgeons and the nuclear radiologists as to the quality, location, and number of~     parathyroid glands, if any, on the scans.~   "
115401|NCT01545609|"~     This study is a randomized controlled trial assessing the effectiveness in a series of~     educational text messages in improving continuation of a birth control method in comparison~     to the 'standard counseling', when girls initiate a new method of birth control. Girls aged~     15-19 year olds who are attending for a reproductive health visit and who own a working cell~     phone will be approached and asked if they would like to participate. Following completion~     of a baseline questionnaire and consultation for initiation of a new birth control method~     they will be randomized to receive either the intervention or standard counseling.~      If randomized to the intervention they will receive 3 messages per week for the initial 3~     weeks, 2 messages per week for the following 5 weeks and then one message per week~     thereafter. Messages will be tailored to the birth control method the participant has~     initiated. At 4 months all participants will be contacted via telephone and asked to~     complete a questionnaire regarding continuation of use.~   "
115402|NCT01545596|"~     The objective of this study is to use a decision-support system combined with an electronic~     anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) <~     75 mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic~     support. Specifically, the project will test the hypothesis that providing Double Low alerts~     reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate~     early clinician responses, subsequent changes in MAP and hospital length of stay.~   "
115403|NCT01545583|"~     The purpose of this study is to investigate the safety and tolerability of LY3016859~     administered as single doses, and to determine how long LY3016859 remains in the body~   "
115404|NCT01545570|"~     This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating~     dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one~     clinical study center in the United States.~   "
115405|NCT01545557|"~     The aim of this study is to assess performance and tolerance as well as investigator and~     subject satisfaction further to pan-facial volume restoration with a new cross-linked~     hyaluronic acid dermal filler containing lidocaine 0.3%.~   "
115406|NCT01545544|"~     An prospective / retrospective multicenter observational study whose objectives are to~     understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The~     characteristics , evolution and treatment of diseases will be observed from the study.~   "
115407|NCT01545531|"~     The purpose of this study is to measure glomerular filtration rate (GFR) by iohexol plasma~     disappearance (gold standard) and measure serum Cystatin C levels (surrogate marker) in~     patients enrolled in our prospective study at baseline, day 100 and 1 year after~     hematopoietic cell transplant and determine if these levels correlate with serum creatinine~     and an estimated GFR using the Modification of Diet in Renal Disease (MDRD) equation and~     Schwartz formula in children.~   "
115408|NCT01545518|"~     The purpose of the initial screening study is to find out if immune problems are an~     unrecognized cause of epilepsy in some patients. This study consists of a single blood~     sample, which will be tested for possible immune abnormalities. If enough patients are found~     who show immune abnormalities, those patients who are still having uncontrolled seizures~     will be invited to participate in a study of immune treatment with a compound called~     intravenous immunoglobulin (IVIG).~      The study hypothesis is that a significant proportion of the young-onset, refractory,~     image-negative, partial-onset epilepsy population have an underlying autoimmune disorder,~     and many of these patients will respond to immune therapies, including IVIG.~      At present, the importance of immune abnormalities in causing epilepsy, and the proper~     treatment when they are found, are both poorly understood. The investigators hope that this~     study will help us understand the cause of some cases that are difficult to treat.~   "
115409|NCT01545505|"~     Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors~     predicting PTSD relapse are still unknown. The aim of this study is to examine whether~     clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that~     characterized PTSD can be observed in people with past PTSD (children and their families)~     and whether these persistent changes are predictive of PTSD relapse.~   "
115410|NCT01545492|"~     INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled~     trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic~     BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in~     pregnancy is better for the baby without increasing maternal risk.~      CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to~     non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing~     and a maternal questionnaire about infant feeding practices and background]. Annual contact~     will be maintained in years 2-5 and contact will include annual parental measurement of the~     child's height, weight and waist circumference.~      OBJECTIVE: To directly test, for the first time in humans, whether differential blood~     pressure (BP) control in pregnancy has developmental programming effects, independent of~     birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less~     tight') control of maternal BP will be associated with fetal under-nutrition and effects~     will be consistent with developmental programming.~   "
115411|NCT01545479|"~     It is well established that renal hypoxia is associated with the development of renal~     injury. The purpose of this study is measure the alterations in renal blood oxygenation~     after angiotensin II converting enzyme inhibition. The understanding of kidney adaptive~     mechanisms to renin angiotensin system effects in healthy subjects will be useful for the~     early detection of renal disease and for the development of new therapies to decrease the~     progression of the disease and its consequences.~   "
115412|NCT01545466|"~     This proposal describes a randomized controlled pilot trial investigating feasibility,~     safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness~     based stress reduction (MBSR) program compared to a wait-list control group.~   "
115413|NCT01545453|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains~     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller~     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment~     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks~     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a~     52-week double-blind active treatment extension. The anticipated time on study treatment is~     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study~     drug for all patients.~   "
115414|NCT01545440|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains~     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller~     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment~     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks~     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a~     52-week double-blind active treatment extension. The anticipated time on study treatment is~     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study~     drug for all patients.~   "
115415|NCT01545427|"~     The purpose of this study is to investigate the effectiveness and safety of the drug Gleevec~     (imatinib) as a new treatment for patients with active diffuse scleroderma. This drug has~     not been used previously to treat scleroderma, but it has been found to advance the~     treatment and life span of patients with a type of leukemia called chronic myeloid leukemia~     or CML. Gleevec acts on chemical signals in the cells that may decrease fibrosis (the~     hardening of the skin that occurs in scleroderma). It works by interfering in the process~     that activates many molecules that cause fibrosis, including TGFbeta (which may be a key~     part of disease activity in scleroderma).~      This study proposes to treat patients that have significant diffuse scleroderma with Gleevec~     for 6 months and investigate several measures of scleroderma disease activity before, during~     and at the end of treatment (0, 3 months and 6 months). This is a randomized, double blind,~     placebo-controlled trial: 20 patients will be divided into two groups in a 4:1 ratio, with~     16 patients taking 400mg of Gleevec per day and 4 taking a placebo. The differences between~     the groups that will be measured include safety, Modified Rodnan skin score (mRSS), Health~     Assessment Questionnaire (HAQ), global assessments (100mm VAS) and changes in biomarkers in~     blood and skin biopsies.~   "
115416|NCT01545414|"~     The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral~     Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety~     symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment~     (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to~     SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that~     ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.~   "
115445|NCT01544062|"~     Patients undergoing cardiac surgery experience significant postoperative pain, which may~     impact postoperative outcomes. The aim of this single center, double-blind, randomized,~     placebo controlled trial is to determine if intravenous (IV) acetaminophen will~     significantly decrease 24 hour postoperative opioid consumption.~   "
115417|NCT01545401|"~     BACKGROUND~      Chronic disease management (CDM) presents enormous challenges to the primary care workforce~     due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was~     proven effective in improving chronic disease outcomes in developed countries. Evidence that~     this model works in developing countries is still scarce. Therefore, the aim of this study~     is to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM~     strategies based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension~     (HPT), using readily available resources in the Malaysian public primary care setting.~      METHODS~      This is a pragmatic cluster randomised controlled trial - participatory action research~     which is currently being conducted in 10 public primary care clinics in Selangor and Kuala~     Lumpur, Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention~     for 1 year, while the other 5 clinics continued with usual care. Each clinic recruits~     consecutive T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a~     2-week period.~      The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM~     Team; and training the team to utilise the Global CV Risks Self-Management Booklet to~     support patient care and reinforcing them to utilise relevant clinical practice guidelines~     to aid management and prescribing.~      For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c~     of <6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients~     achieving target blood pressure of <140/90 mmHg. Secondary outcomes include the proportion~     of patients achieving targets serum lipid profile, body mass index and waist circumference.~     Other outcome measures include medication adherence levels, process of care and prescribing~     patterns. Patients' assessment of their chronic disease care, providers' perception,~     attitude and perceived barriers in delivering the care and cost-effectiveness of the~     intervention are also evaluated.~      CONCLUSION~      Results from this study will provide objective evidence of the effectiveness and~     cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint~     public primary care setting. It is hoped that the evidence will instigate the much needed~     primary care system change in Malaysia.~   "
115418|NCT01545388|"~     This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice~     daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes~     mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and~     sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg~     b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from~     baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg~     q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline~     in HbA1c at 24 weeks.~   "
115419|NCT01545375|"~     The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis~     media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine~     GSK2189242A in Native American infants aged less than 24 months, living in the southwestern~     US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the~     impact on acute lower respiratory tract infections (ALRI) up to the second year of life.~   "
115420|NCT01545362|"~     To determine if preop nutritional status is an indicator for outcomes of bilateral staged~     total knee arthroplasty. The investigators expect that patients having staged bilateral~     total knee arthroplasty with the second procedure performed within one week of the first and~     have a total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams~     per liter will have the same or less complications and shorter length of stay than those~     with lower lymphocyte count and albumin level.~   "
115421|NCT01545349|"~     This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated~     influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of~     several strains of Lactobacilli that is used as a probiotic or microorganism administered to~     confer health benefits. Our research is focused on studying the possible therapeutic~     effects of LGG. The study hypotheses are:~        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly~          subjects who have just received the live attenuated influenza vaccine,~        2. The immune response to the influenza vaccine at day 21, 28, and 56 will be higher in~          the LGG group than the placebo group,~        3. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28,~          and 56 will be greater in the LGG group than the placebo group.~   "
115422|NCT01545336|"~     The main purpose of this clinical trial is to study the safety and efficacy of anastrozole~     in adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how~     well the drug is tolerated. The study will also evaluate if anastrozole effects estradiol~     (E2) hormone levels, a sex hormone, and improves the function of the lower right chamber of~     the heart (right ventricle).~   "
115423|NCT01545323|"~     Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This~     gene controls the formation of a protein called LEKTI, which important for skin barrier~     function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the~     skin (epidermis). The function of the serine proteinases is to break down the intracellular~     cement that holds together the horny cells in the epidermis, in order for the skin to be~     able to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited~     desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier~     function of the skin is also affected. The permeability of the skin increases, and its~     capacity to bind water decreases, which causes dryness. The thinness of the barrier also~     results in over absorption of chemicals, for example topical medical treatments.~     Historically one in ten infants dies before their first birthday. Currently there are no~     proven treatments to cure this condition.~      The investigators have been developing a gene therapy approach to treat this disorder. The~     investigators have used a disabled virus (vector) to carry a functional copy of the SPINK5~     gene into skin stem cells. Proof-of-principle experiments have shown the investigators can~     restore almost normal shape and size of the upper layer of the skin in skin grafts grown in~     the lab. Even if only a small number of cells are genetically modified to carry the~     corrected SPINK5 gene, there seems to be a correction over a wide area of the graft.~      In this trial the investigators propose grafting of autologous epidermal sheets generated~     from genetically modified skin stem cells for the treatment of patients with Netherton~     Syndrome. The investigators anticipate production and release of LEKTI protein from even a~     small patch of skin will be beneficial.~   "
115424|NCT01545310|"~     This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor~     occupancy in the brain using positron emission tomography (PET) following single oral doses~     of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia,~     between 18-55 years of age are to complete the study.~   "
115442|NCT01544101|"~     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a~     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a~     control supplement or a placebo. The principal measure is pain as measured by Visual Analog~     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,~     respectively. The study duration is 36 weeks.~   "
115443|NCT01544088|"~     The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT)~     is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a~     primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive~     group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment~     of PTSD and related symptoms will be conducted at pre-treatment, mid treatment,~     post-treatment, and 3-, 6-, - and 12-month follow-up.~   "
115425|NCT01545297|"~     Awake craniotomy for resection of brain tumor located in close proximity to areas of~     eloquent brain function, such as speech, motor and sensory, is an accepted procedure used to~     minimize neurological injury during resection. During awake craniotomy, anesthesia is~     usually provided using a combination of local anesthesia (regional scalp block and/or local~     infiltration) and intravenous (IV) agents to provide sedation, anxiolysis and analgesia.~     Propofol sedation, commonly in combination with a shorter acting opioid such as fentanyl, or~     remifentanil, is an effective and popular technique during awake craniotomy, achieving a~     high degree of patient satisfaction and acceptance. Most of the anesthetic agents are~     associated with some respiratory depression.~      The anesthetic agent called dexmedetomidine is a potent, highly selective α2-adrenoceptor~     agonist. The effects of dexmedetomidine are anxiolysis, analgesia, sedation and~     sympatholysis, and it is not associated with respiratory depressive effect. Bekker et al.~     first reported the successful use of dexmedetomidine in awake craniotomy in 2001.~      The purpose of this blinded, prospective, randomized study is to compare the efficacy of~     dexmedetomidine versus propofol-remifentanil based sedation in patients undergoing awake~     craniotomy for resection of tumors. The study hypothesis is that the efficacy of performing~     intra-operative brain mapping is identical between dexmedetomidine and the~     propofol-remifentanil based sedation. The primary end-points are to assess the ability to~     perform intraoperative mapping during awake craniotomy. Secondary end-points will assess the~     incidence of complications (respiratory depression, failure to provide adequate analgesia),~     as well as patient and surgeon satisfaction to the corresponding anesthetic technique.~   "
115426|NCT01545284|"~     This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate~     the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .~   "
115427|NCT01545271|"~     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with~     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard~     treatment for this condition. The hypothesis is that the xenon + cooling combination will~     produce better neuroprotection than the standard treatment of cooling alone.~   "
115428|NCT01545258|"~     A commonly administered conservative non-pharmacological treatment for OA is exercise, with~     beneficial effects in terms of reduced pain and disability.~      While the link between exercise and reduced disability is mediated by e.g. increased muscle~     strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA~     patients have both peripheral and central sensitization of pain mechanisms resulting in~     hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral~     and central mechanisms but it unknown if exercise affects either of these mechanisms.~      It is hypothesized that in knee OA patients exercise reduces the pain sensitivity~   "
115429|NCT01545245|"~     The primary objective of the study is to determine whether the incidence of atopic asthma~     after three years old may be suppressed in the children who were born as preterm infants and~     prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections~     during the infancy.~      The secondary objective is to determine whether the incidence of recurrent wheezing after~     three years old may be suppressed in the children who were born as preterm infants and~     prophylactically treated with palivizumab for RS virus infections during the infancy.~   "
115430|NCT01545232|"~     Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial~     designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted~     to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells~     (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which~     clinicians make decisions about transfusion protocols for massively bleeding patients.~      PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National~     Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and~     the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial~     at Level I Adult Trauma Centers in North America.~   "
115431|NCT01545219|"~     Healthy volunteers will be recruited to a study where they will be given four different~     treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a~     synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be~     collected and analysed for changes in faecal microbial populations and selected immune~     responses.~   "
115432|NCT01545206|"~     The investigators tried to determined whether the less D2B time led to costs savings~     benefited insurance payer and better outcomes to patients.~   "
115433|NCT01545193|"~     Residual neuromuscular blockade is frequently observed in the early postoperative period~     when patients have received a general anesthetic with muscle relaxants. At the present time~     it is uncertain whether certain patient populations are at greater risk for this common~     anesthetic complication. However, it is possible that elderly surgical patients may exhibit~     a higher incidence of residual neuromuscular blockade. The aim of this clinical trial is to~     determine the incidence of residual neuromuscular blockade in a cohort of younger (ages~     18-50) and older (ages 70-90) patients undergoing surgery and general anesthesia.~   "
115434|NCT01545180|"~     This study will better understand the post-capillary pulmonary hypertension in heart~     failure, to determine its prognostic role and to consider specific treatment of different~     forms of pulmonary hypertension in post-capillary pulmonary heart failure.~   "
115435|NCT01545167|"~     This study will investigate several genes and other factors measured in the blood that may~     cause recurrent acute pancreatitis and chronic pancreatitis.~   "
115436|NCT01545154|"~     This study is being done to find out if transperineal ultrasound (TPUS) can help define the~     prostate gland for radiation treatment planning and improve upon current methods of image~     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement~     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they~     are lying on their back in the position they will receive their treatment. Image-guidance is~     required for the treatment of prostate cancer because the prostate shifts position depending~     on how full the bladder and rectum are. Image-guided radiation therapy has been done at~     Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal~     ultrasound images are obtained every day and compared to an ultrasound that was done on the~     day of treatment planning. Adjustments in radiation field position can be done on a daily~     basis by comparing these images. Transperineal ultrasound has never been used for~     image-guidance. The investigators completed an earlier study and have developed a TPUS~     device and process that allow us to get clear ultrasound pictures of the prostate gland. The~     TPUS has three potential advantages over the transabdominal method the investigators~     currently use:~        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get~          clearer images, however it is difficult for some men with prostate cancer to~          comfortably keep a full bladder. It is also particularly difficult to get good images~          in larger men who have long distances from the skin surface to the prostate gland. TPUS~          is not dependent on a man having a full bladder and should be less dependent on the~          size of the man.~        2. TPUS images and the planning CT images can be acquired simultaneously. This is not~          possible with the abdominal probe because it gets in the way of the CT machine.~          Simultaneous imaging eliminates the possibility of the prostate gland shifting~          positions during the time between imaging studies.~        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe~          gets in the way of the treatment machine) and may in the future allow us to watch the~          prostate gland during treatment. If the investigators discover that they can accurately~          view the prostate gland in real time, TPUS may ultimately allow us to treat even~          smaller radiation fields and possibly decrease the risk of radiation complications.~      Patients in this study will be treated for their prostate cancer with the standard image~     guidance techniques used at Fletcher Allen Health Care: transabdominal ultrasound and/or~     X-ray imaging of gold marker seeds that have been placed the prostate gland. In addition to~     standard care, all men in this study will have TPUS and CT scans done a total of four times~     over 12 weeks to compare these methods of prostate localization over the course of radiation~     treatments. Some men may choose to take part in an additional study that will also include~     MRI of the pelvis to compare with the TPUS and CT. Because the prostate gland can be more~     clearly defined on MRI, some institutions (not Fletcher Allen) routinely have patients with~     prostate cancer get MRI scans for treatment planning. This has not been proven to improve~     the care of men with prostate cancer and it is possible that TPUS will provide similarly~     clear images. The potential advantages to TPUS imaging for prostate localization over MRI~     include the fact that it is done at the same time as the CT for treatment planning (so~     eliminates the possibility of movement of the prostate gland from the time of the MRI to the~     time of the CT) and can be done at a much lower cost.~   "
115437|NCT01545141|"~     Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with~     recurrent colorectal cancer. This will also test whether the above combination can help the~     immune system to fight the tumors. The results will allow the investigators to determine the~     preferred combination for subsequent extended studies.~   "
115438|NCT01544153|"~     This study will compare the efficacy of an interactive, evidence-based smoking cessation~     website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social~     network (SN) protocol designed to integrate participants into the online community, and 2)~     access to a 4-week supply of free NRT.~   "
115439|NCT01544140|"~     The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of~     Midazolam administered alone and in combination with Vandetanib.~   "
115446|NCT01544049|"~     The purpose of this study is to better understand why women choose to have their fallopian~     tubes removed as a method for ovarian cancer prevention. This will be done through a paper~     questionnaire and phone interviews. The investigators hope to gain information that will~     allow us to better counsel women about ovarian cancer prevention.~   "
115447|NCT01544036|"~     Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated~     with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM)~     induce kidney injury through vasoconstriction and ischemia as well as direct tubular~     toxicity. Older subjects, individuals with preexisting kidney disease, diabetes,~     hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within~     the last several years, multiple strategies have been used in clinical studies to reduce the~     risk of CN in high risk individuals with inconsistent results. In general, it is agreed that~     volume expansion is effective in reducing the risk. However, no study has looked at changes~     in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to~     investigate its relationship with occurrence of CN.~      In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an~     estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25~     individuals with normal renal function (total of up to 150 individuals) who are scheduled~     for coronary angiography will be studied. Each individual will have serial measurements of~     RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM,~     using the novel technique of contrast enhanced ultrasound (CEU). The investigators will~     investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a~     rise of > 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM)~     after adjusting for other known risk factors in the group of subjects with reduced GFR. The~     investigators will also examine the correlation between RBF changes and other urinary and~     serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney~     function will be studied in a separate part of the study in which the accuracy of CEU based~     measurements of RBF will be compared to the RBF and blood flow velocity obtained~     simultaneously using a Doppler flow probe placed directly inside the main renal artery~     during coronary angiogram procedure. Total to enroll = 150.~   "
115448|NCT01544023|"~     A new approach for single stage implant based breast reconstruction (BR) is the use of a~     titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix~     (ADM). These TCPM have a good biocompatibility and can be used in a similar way as ADM. This~     study addresses indications, limitations and complications of TCPM in implant based breast~     reconstruction.~   "
115449|NCT01544010|"~     This study explored optimal tailoring strategies for population tobacco cessation in 4~     treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored~     feedback on all 14 variables has been found to be a robust population cessation strategy~     across studies. This proposal sought to find a subset of these variables that is optimal for~     tailoring, both minimizing response burden while maximizing effectiveness. Addiction~     variables have been demonstrated to predict smoking outcomes across studies as well, so we~     will integrate tailored feedback using TTM and addiction variables into an enhanced~     tailoring group. Optimally tailored feedback that both helps unmotivated smokers reduce~     their addiction and helps motivated smokers quit could lead to a breakthrough in population~     cessation.~   "
115450|NCT01545128|"~     The purpose of this study is to study the direct cost of illness study of COPD patients who~     participated in a Pulmonary rehabilitation program for 8 weeks.~   "
115451|NCT01545115|"~     Longitudinal survey in Northern Senegal to investigate the environmental factors modulating~     the immune response to childhood vaccines and to malaria.~      A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor~     District) was followed-up for 18 months. During that period, 5 visits have been made to the~     villages to assess the immunological and nutritional status of the children.~   "
115452|NCT01545102|"~     Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic~     heart failure (CHF), since it addresses the complex interplay of medical, psychological and~     behavioural factors facing these individuals. Structured exercise training within a cardiac~     rehabilitation programme is firmly recommended for these patients. However, it is~     questionable whether patients are achieving an adequate dose of exercise to provide optimal~     benefits. The essential components for setting optimal training include the appropriate~     mode, duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation~     describe the frequency and duration of training, but here is scant information on exercise~     intensity. However, it is apparent that randomised controlled trials of exercise training~     use doses more than 4 times greater than in UK current practice. The Eastbourne Exercise~     Cardiology Research Group has demonstrated that although patients benefit from improved~     quality of life and submaximal fitness after a hospital outpatient cardiac rehabilitation~     programme, they do not achieve the increases in important prognostic indicators reported by~     the majority of exercise training trials.~      The critical factor in terms of eliciting a sufficient training effect while minimising risk~     is the intensity of the exercise performed. It is now widely accepted that the traditional~     methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise~     intensity include serious errors. The European Society of Cardiology recommends that~     cardiopulmonary exercise testing should be used to provide an objective evaluation of the~     metabolic demand of exercise. This allows physiologically meaningful reference points to be~     established for aerobic exercise prescription and is the solution to defining safe and~     effective training intensities. The next step is to determine whether this information can~     be transferred to a practical cardiac rehabilitation environment to set and monitor exercise~     intensity~   "
115453|NCT01545089|"~     The main objective of this research project is to measure the impact on patient satisfaction~     of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.~   "
115454|NCT01545076|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20~     compared with placebo for maintenance treatment of patients with CIDP.~      Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks~     before screening will be assessed during 4 separate study periods. Patients first undergo a~     Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for~     ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will~     be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients~     with improved and maintained adjusted inflammatory neuropathy cause and treatment scale~     (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the~     study. Patients entering the 24 week SC Treatment Period will be randomized to receive~     weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.~      The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the~     Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the~     Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS),~     and electrophysiological evaluations.~   "
115455|NCT01545063|"~     This research aims to give an overview of a number of aspects related to the quality of care~     for adult patients on home parenteral nutrition.~      Concretely this study follows up different aspects on different moments in the care of the~     patient pathways:~        -  process indicators concerning indication, parenteral nutrition, training, team access~          roads and the succession of complications~        -  Outcome indicators~        -  the health-related quality of life~        -  discrepancies in medication use~        -  the role of the different health care providers~   "
115458|NCT01545024|"~     Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is~     regulated by the enteric nervous system, the afferent and efferent vagus nerves [1].~     Further, Kazakos et al. [2] reported that autonomic nerve disturbance (AND) in patients with~     T2DM impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen~     et al. [3] reported that the decreased GLP-1 responses in the patients with type 2 diabetes~     mellitus (T2DM) are unlikely to be related to the AND and, thus, did not support the results~     of Rocca et al. and Kazakos et al. Recently, Yabe at al. [4] also observed the same~     observations in Japanese patients with T2DM. Meanwhile, Jin et al. reported that~     administration of DPP-IV inhibitor recovered the disturbance of diabetic nerve dysfunction~     in rat [5]. However, it is unknown whether the administration of DPP-IV inhibitor effects on~     the AND in human, although many studies are performed to investigate the effect of the~     DPP-IV inhibitors on glycemic control.~      Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic~     control and autonomic neuropathy in diabetic patients.~   "
115459|NCT01545011|"~     The purpose of this study is to determinate whether inspiratory muscle training (IMT)~     associated with a conventional respiratory rehabilitation program is more effective than a~     conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive~     pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60~     cmH2O).~   "
115460|NCT01544998|"~     This study is being done to determine the effects of subcutaneous (under the skin) injection~     of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the~     heart, in combination with Tadalafil on:~        -  The pumping function of the heart~        -  Kidney function~        -  Hormonal function (levels of different hormones in your blood) in persons with lower~          pumping function of their heart.~   "
115461|NCT01544985|"~     INTRODUCTION AND JUSTIFICATION~      The use of sucrose has been well studied for certain procedures in neonatal intensive care~     unit patients and in the newborn nursery settings, particularly for venous blood draws,~     capillary blood tests and circumcision. In these studies, infants receiving oral sucrose~     solutions before procedures cried less and had overall decreased behavioural pain responses~     when compared with those receiving placebo.~      In Emergency Departments (ED), children undergo many painful procedures, such as bladder~     catheterization, capillary blood tests, venipuncture and lumbar puncture. Only two studies~     have examined the effectiveness of sweet solutions as an analgesic in the ED. A randomized~     controlled trial in an emergency setting of sucrose and/or pacifier for infants receiving~     venipuncture conducted by Curtis and al among infants of 0 to 6 months demonstrated a trend~     in reducing pain among the sub-group of infants of 0 to 3 months. However, this study showed~     no difference in pain scales after 3 months of age. Also, in a study examining the effect of~     sucrose during bladder catheterization, the subgroup of infants 1 to 30 days old who~     received a sweet solution showed smaller changes in pain scores, were less likely to cry~     during catheterization and returned to baseline more quickly, in comparison with the placebo~     group. However, among children of 31 to 90 days, there was no statistically significant~     difference in pain scores. In this study, they used a sucrose solution of only 24% and as~     they said in the discussion, it is possible that older infants, who on average received a~     smaller dose (in milligrams per kilogram), were in fact underdosed.~      Finally, the painful procedure chosen for this study is bladder catheterization. Bladder~     catheterizations are frequently performed in the ED in this age group.~      HYPOTHESIS The investigators believe that providing an oral sucrose solution during bladder~     catheterization will decrease pain levels in infants 1 to 3 months of age.~      OBJECTIVES The investigators primary objective is to compare the efficacy an oral 88%~     sucrose solution to a placebo solution in reducing pain as assessed by the FLACC scale in~     children of 1 to 3 months during bladder catheterization in the ED. The investigators~     secondary objective is to asses changes in pain levels as per the NIPS score. The~     investigators will also measure variations in heart rate and crying time. All side effects~     will also be reported.~   "
115462|NCT01544972|"~     The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety~     in relation to serum levels in closure of patent ductus arteriosus in preterm infants.~   "
115463|NCT01544959|"~     The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol~     during general anesthesia for patients undergoing mastectomy will result in less pain and~     less narcotic consumption in the recovery room. The investigators will also verify the~     impact of that substitution on nausea and vomiting, on the time spent in the recovery room~     and on chronic postsurgical pain (3 and 6 months).~      Finally, the investigators will see the impact on breast cancer recurrence 5 years after the~     surgery.~   "
115464|NCT01544946|"~     Background: Early recognition and treatment of pain among children is important for their~     cognitive development and their future response to pain throughout their life. Oral sweet~     solutions have been accepted as effective pain reducing agents for procedures in the~     neonatal population. To date, there have been a limited number of published clinical trials~     in an emergency setting studying this type of intervention among infants undergoing venous~     puncture and bladder catheterization. These studies have reported conflicting results. No~     previous studies have evaluated the utilization of sucrose to manage pain during~     nasopharyngeal aspiration.~      Objective: To compare the efficacy of an oral sucrose solution versus placebo in reducing~     pain in children one to three months of age during nasopharyngeal aspiration in the~     Emergency Department.~   "
115465|NCT01544933|"~     The purpose of this study is to analyse the anatomic influence of the ribs related to the~     incidence and severity of burst spine fractures.~   "
115466|NCT01544920|"~     The primary purpose of this study is to compare the efficacy of two boceprevir~     (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic~     hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.~      The regimens differ in the treatment for participants who achieve undetectable HCV~     ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin~     (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN +~     RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of~     participants with undetectable HCV RNA at Follow-Up (FU) Week 24.~   "
115467|NCT01544907|"~     A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty~     versus conventional percutaneous transluminal angioplasty balloon for the treatment of~     hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late~     luminal loss and restenosis rates, while prolonging primary and secondary patencies.~   "
115468|NCT01544894|"~     The purpose of this study was to compare compliance and efficacy of raloxifene and strontium~     ranelate in a group of women with postmenopausal osteoporosis.~   "
115469|NCT01544881|"~     This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response~     (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.~   "
115479|NCT01544751|"~     The first line approach to NAFLD is currently based on diet and lifestyle modification. Aim~     of our Unit is to compare the efficacy of two different doses of metformin (1 g/day and 2~     g/day) with atorvastatin (20 mg/day) on amelioration of inflammatory and cardiometabolic~     parameters, ultrasound signs and clinical scores associated with liver fibrosis in~     early-stage NAFLD non-diabetic patients.~   "
115470|NCT01544868|"~     The purpose of this study is to measure resting energy expenditure, total energy~     expenditure, and physical activity in recovering burn children to better understand their~     relation to impaired growth and nutritional status; and to measure whole body and muscle~     protein turnover during recovery from burn injury to understand their impact on body~     composition and energy metabolism. It also aims to look at changes in lean body mass, fat~     mass, bone mineral density and bone mineral content during rehabilitation and during early~     convalescence.~   "
115471|NCT01544855|"~     Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the~     elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is~     prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does~     not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing~     docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may~     be incorporated as a prevention strategy for lowering the risk of AD. However, fish intake~     seems not to protect APOE4 carriers from developing AD. One explanation as to why APOE4~     carriers may not benefit from fish intake is potentially linked with imbalances in omega-3~     fatty acid metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6~     weeks, increases in the two fatty acids was less for carriers resulting in a significant~     gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate~     the fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators~     hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein~     concentrations which has the consequence to be associated with imbalances in EPA and DHA~     transport. The investigators will recruit and test 100 healthy young adults since at older~     ages carriers of ApoE4 usually take medication altering their lipoprotein profile. They will~     receive an EPA + DHA supplement for one month. This period was chosen because the 3 class of~     lipoproteins (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and~     cholesteryl esters and to fully investigate lipoprotein fatty acid changes, one month of~     supplementation is needed to change EPA and DHA in all lipid classes. The investigators will~     monitor the distribution of EPA and DHA in the lipoproteins over a one month supplementation~     with fish oil and the investigators will separate the investigators groups by APOE4 carriers~     and non-carriers.~   "
115472|NCT01544842|"~     The purpose of this study is to compare the effectiveness of topical tacrolimus,~     triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).~   "
115473|NCT01544829|"~     The main aim of this study is to determine whether there is a difference in the~     physiological effects of theobromine when provided via a single serving compared to multiple~     servings adding up to the same amount of theobromine provided on a day.~      This study also aims to study the pharmacokinetics of theobromine after administration once~     per day versus administration 4 times per day.~      Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is~     given in 4 smaller doses.~   "
115474|NCT01544816|"~     To determine the effect of snack products varying in composition, on energy in healthy adult~     subjects.~   "
115475|NCT01544803|"~     Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed~     randomized controlled design, measuring outcomes in terms of changes in problematic alcohol~     use up to one year after study recruitment. The eScreen brief Internet intervention for~     problematic alcohol and drug use offers self-screening, in-depth self-reporting,~     personalized feedback and treatment recommendations as well as an electronic diary. Progress~     over time is shown in diagrams detailing consumption levels. A more extensive Internet~     intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based~     psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.~      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are~     randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen~     referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related~     symptoms are assessed after 3, 6 and 12 months.~      The first hypothesis is that all three groups will reduce their alcohol consumption and~     alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis~     is that there will be no differences between participants in the eScreen and the~     Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at~     follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen~     group will show a greater reduction in alcohol consumption and alcohol-related problems~     compared to the control group (no intervention) at follow-ups. For a greater understanding~     of the study results possible other interventions received by the study participants for~     their problematic alcohol use during these 12 months of study participation will be~     investigated.~   "
115476|NCT01544790|"~     This is the first randomized controlled trial designed to compare robot-assisted minimally~     invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as~     surgical treatment for resectable esophageal cancer.~      If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic~     esophagectomy will result in a lower percentage of postoperative complications, lower blood~     loss, shorter hospital stay, but with at least similar oncologic outcomes and better~     postoperative quality of life compared with the open transthoracic esophagectomy (current~     standard).~   "
115477|NCT01544777|"~     To evaluate visual acuity and quality of vision in participants undergoing cataract surgery~     with a Hoya model 751 intra-ocular lens and to compare the visual results to the common~     monofocal lens in use.~   "
115478|NCT01544764|"~     The North Carolina Immunization Branch will evaluate the use of the CDC program to improve~     adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or~     AFIX). This evaluation is the first of its kind in the nation and may have a profound impact~     on prevention.~      AFIX has four major components: 1) Assessment of a provider's current immunization practices~     and vaccination levels, 2) Feedback of the assessment results and strategies to improve~     coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information~     and resources necessary to facilitate improvement.~      This program will evaluate the effectiveness of AFIX visits on affecting provider practices~     to increase adolescent (age 11-18) immunization. Visits include discussion of that~     practice's immunization rates and strategies for improving rates. The investigators will~     compare the changes, from baseline to 5 months, in immunization for practices receiving~     virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices~     will be randomly assigned to each intervention type. The main outcomes of this study are~     practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as~     pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data~     will be collected on practices with at least 200 adolescent patients (note: there is no~     patient-level data collected in this study).~   "
115504|NCT01544426|"~     Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI)~     cycles , in cases of repeated implantation failure. It is found that it will improve the~     implantation rate.~   "
115480|NCT01544738|"~     Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease~     (PD). Several studies have shown that patients with PD exhibit slowness because they are~     unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by~     external stimulation. Indeed, these patients have difficulties to integrate multi-sensorial~     information, mainly proprioception.~      The investigators investigated changes in shoulder velocity during pointing movements by~     patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The~     stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the~     aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has~     previously been shown to decrease passive tension and the tendon reflex response of the~     manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of~     shoulder muscles therefore creates a modification in the proprioceptive information, which~     in return temporarily decreases the bradykinesia of shoulder movements.~   "
115481|NCT01544725|"~     Using Ketamine for procedural sedation in adults is often uncomfortable for emergency~     physicians because of the significant proportion of patients experimenting recovery~     agitation. The investigators believe that combining propofol to ketamine, the proportion of~     recovery agitation will be significantly lowered.~      The objectives of this double-blinded, randomized controlled trial are to compare the~     proportion of recovery agitation in adults receiving procedural sedation with~     ketamine-propofol versus ketamine alone, and to compare the proportion of other classical~     procedural sedation side-effects and parameters such as respiratory depression, hypotension,~     sedation duration, time of recovery, procedural failures, and levels of satisfaction.~   "
115482|NCT01544712|"~     In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow~     grafting was reported with a reduction of the functional evolution and the necessity of a~     total prosthesis placement in a non-controlled retrospective trial. Based on this~     experience, the investigators would like to start a randomized controlled double blind study~     on the effect of autologous implantation of autologous bone marrow cells into the necrotic~     lesion of stage 3 ON of the femoral head.~   "
115483|NCT01544699|"~     tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to~     improve a variety of functions with superior or inferior limb.~   "
115484|NCT01544686|"~     In neutropenic cancer patients, catheter-related bloodstream infections may cause severe~     infections and even death. To assess the prophylactic effect of a chlorhexidine coated~     catheter securement dressing on the incidence of catheter-related bloodstream infections,~     this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will~     be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.~   "
115485|NCT01544673|"~     Results from previous studies have been inconclusive and the effect of linezolid on~     cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the~     functionality of white blood cells (neutrophils and monocytes) in healthy subjects.~   "
115486|NCT01544660|"~     Our overarching aim is to set up a procedural, analytic and developmental framework to~     establish CT of the central and peripheral skeleton as a clinically useful biomarker for~     skeletal strength in the clinical research and ultimately in the clinical setting. To~     accomplish this, the investigators will develop and validate phantoms and scanning~     procedures to standardize strength and structure measurements between different vQCT~     scanners and develop standardized acquisition, analytical, and quality control techniques~     for HR-pQCT with an emphasis on optimization for multi-center studies.~   "
115487|NCT01544647|"~     Non-pharmacological treatments are recommended for the management of knee osteoarthritis~     (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving~     symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known~     about the advantage of one modality of thermal therapy over another.~      The main objective of the study is to compare the number of patients achieving a composite~     response criteria associating the minimal clinically important improvement at 6 months,~     defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised~     Western Ontario and McMaster Universities osteoarthritis index function score and no knee~     surgery in 2 spa therapy protocols (a usual protocol and an active protocol) in knee~     osteoarthritis.~      The secondary objectives are:~        1. To compare the efficacy of the 2 protocols at 3 months.~        2. To determine the evolution of quality of life and medical care consumption~        3. To describe postural abnormalities~        4. To determine predictive factors to a favourable response at 3 and 6 months~   "
115488|NCT01544634|"~     Current asthma medicines include inhalers. A common type of inhaler is called a~     'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the~     airway causing it to widen. Although these drugs are useful short term, long term use can~     make asthma worse in some people.~      'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in~     patients with asthma. Beta-blockers cause problems in asthmatics in the short term,~     including severe asthma attacks.~      The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer'~     medication. These work by dampening down the inflammation in the lungs that occurs in~     asthma.~      New research has suggested that longer term use of beta-blockers can also reduce airway~     inflammation which may improve asthma control. This research was done in asthmatic patients~     who didn't need inhaled steroids to control their asthma. At the moment the investigators~     are studying to see if there is a benefit of beta-blocker use for asthma over and above~     asthmatics own usual doses of inhaled steroids.~      In this study, the investigators will be trying to find out if adding a beta blocker to a~     smaller dose of steroid inhaler has the same effect on asthma control as just using a higher~     dose of steroid inhaler by itself.~   "
115489|NCT01544621|"~     Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40~     General Practice (GP) centers with 800 smokers will participate.~   "
115490|NCT01544608|"~     The primary objective of this Non- Interventional Study (NIS) is to describe the use of~     atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to~     acute psychotic episode by evaluation of drug, dose and mode of administration of the~     medication.~   "
115534|NCT01543880|"~     This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy~     in adults treated with somatropin (Norditropin®).~   "
115491|NCT01544595|"~     This is an extension study of secukinumab prefilled syringes in subjects with moderate to~     severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with~     secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies~     (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III~     studies) will be eligible to join this extension study. This extension study is planned to~     collect an additional 2 years of long-term efficacy, safety, and tolerability data of~     secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in~     subjects showing at least partial response to secukinumab and completing treatment period on~     secukinumab in previous phase III studies. In this extension study, the prefilled syringe~     (PFS) liquid formulation of secukinumab will be used.~   "
115492|NCT01544582|"~     This is an observational prospective follow-up study to assess the utilization of boceprevir~     and the management of pre-specified health outcomes of interest (HOIs) under conditions of~     routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.~      As an observational prospective study, this study is not intended to change the~     participant/physician relationship, nor influence the physician's drug prescription or~     therapeutic management of the participant. No individual administration of any therapeutic~     or prophylactic agent is assigned in this protocol, and there are no procedures required as~     part of this protocol. Physician choice of the drug used to treat the participant is based~     on clinical judgment alone.~   "
115493|NCT01544569|"~     RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory~     may help doctor learn more about changes that occur in DNA and identify genes related to~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid~     tumors.~   "
115494|NCT01544556|"~     Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The~     appearance of the scar is a major factor contributing to the aesthetic outcome of the~     procedure and depends largely on the technique of wound closure. The investigators routinely~     used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure.~     To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives~     were introduced as a new technology. The new PrineoTM wound closure system was created to~     combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a~     self-adhering mesh to make closure of long skin incisions even more safe and reliable.~     PrineoTM has the potential to offer a patient several benefits over traditional wound~     closure with sutures.A patient treated with Prineo™ can shower immediately following a~     procedure because the product forms a watertight barrier over the incision. PrineoTM can be~     easily removed, often with less pain than is sometimes associated with suture removal, after~     the natural wound healing process is complete (approximately 12 to 25 days). Other benefits~     are that it forms a microbial barrier and provides even distribution of tension across the~     length of the incision to ensure wound edge approximation throughout the wound healing~     process. Furthermore, it reduces subcuticular closure time as compared to subcuticular~     suturing.~      However, these potential advantages have not been proven until now, as the methods used to~     assess the aesthetic outcome were not reproducible in most assessments, and none of these~     studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical~     patient population. For these reasons, the investigators prospectively studied the results~     of wound closure after abdominoplasty with randomized use of PrineoTM and conventional~     suturing to assess the possible difference in outcome between these two methods.~   "
115495|NCT01544543|"~     VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability~     and interobserver reliability) of healthcare quality standards in chronic obstructive~     pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery~     Society), and at establishing the foundation for a future validation (construct and~     criterion validation) of the aforementioned standards.~   "
115496|NCT01544530|"~     The purpose of this study is to assess the feasibility and safety of mild-to-moderate~     hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60~     brain-dead organ donors.~   "
115497|NCT01544517|"~     A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential~     therapy for eradication of H. pylori infection.~   "
115498|NCT01544504|"~     This study, a nonrandomized open-label safety and exploratory study, will evaluate the~     safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing~     radiation therapy.~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation dermatitis experienced by these patients.~   "
115499|NCT01544491|"~     The purpose of this study is to determine if everolimus combined with reduced exposure CNI~     (TAC) is efficacious and safe and will support corticosteroid elimination compared to a~     standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation.~     An additional purpose of the study is to assess the effect of the combination of EVR and~     reduced exposure CNI (TAC) on renal function.~      This study is part of the requirements of the Paediatric Investigational Plan approved by~     Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and~     is intended to support the indication of everolimus in the prevention of acute rejection in~     paediatric recipients of a renal transplant.~   "
115500|NCT01544478|"~     This study will evaluate the long term safety of quadrivalent Human Papillomavirus (HPV)~     types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical~     intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV~     in Japanese women.~   "
115501|NCT01544465|"~     The purpose of this study is to examine the ability of a structured physical activity~     program to improve sleep quality and daytime sleepiness in patients with Parkinson's~     disease.~   "
115502|NCT01544452|"~     Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or~     thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic~     evaluation before surgery. MR colonography have been shown to have high sensitivity and~     specificity for larger polyps and cancer and MRI of the liver have been shown to have~     similar or higher sensitivity than CT of the liver for metastasis. Since patients already~     undergo MR of the rectum, the investigators have proposed a total diagnostic evaluation with~     MRI of the liver, abdomen, colonography and rectum in one session (minus thorax evaluation)~     instead of two or three different methods of evaluation. The investigators hypothesis is~     that the total MR evaluation is equal or superior to the existing preoperative evaluation~     regarding the diagnosis of synchronous cancers and liver metastasis and regarding~     cost-benefit for the total diagnostic evaluation.~   "
115503|NCT01544439|"~     The aim of this study was to evaluate the effectiveness of the splint occlusal associated~     with counseling in reducing pain in patients with temporomandibular disorders, under the~     assumption that the occlusal appliance offers the highest rates of improvement than their~     placebo.~   "
115505|NCT01544413|"~     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric~     cancer is less invasive method which can increase quality of life. Multicenter phase III~     trial is requred to validate this method. In this study all items which are necessary for~     laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated~     the performance completement.~   "
115506|NCT01544400|"~     Athletes in particular elite athletes have obsessional food and body concerns, in bond with~     a worship of the performance more and more invading, which lead to clinical and subclinical~     eating disorders. These eating disorders differ according to the disciplines and are~     difficult to diagnose in athletes because there are insufficiently described.~      Our aim at estimating the frequency of eating disorders in athletes and describing eating~     disorders by means of somatic, dietetic and psychological evaluations.~   "
115507|NCT01544387|"~     The objective of this study is to determine, through a randomized clinical trial, whether~     bed rest is helpful for the management of pregnancies complicated by preterm premature~     rupture of membranes (PPROM).~   "
115508|NCT01544374|"~     Breast cancer is the second most common cause of cancer death in women. Black women are less~     likely than white women to develop breast cancer but, they are more likely to die of the~     disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies~     proven to increase survival. Breast cancer treatment often requires coordination among~     surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC,~     black and Hispanic women who accessed care and underwent surgical treatment of their breast~     cancer were twice as likely as whites to experience underuse of adjuvant treatment.~     Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended~     treatment, the patient did not refuse and yet, care did not ensue. Underuse in such~     circumstances is attributable to system failures than to specific provider or patient~     factors.~      In this proposed randomized controlled trial, the investigators aim to test the~     effectiveness of a Tracking and Feedback (T&F) registry innovation to increase rates of~     completed oncology consultation and reduce both underuse of needed adjuvant therapy and~     racial disparities in receipt of these treatments. The investigators also aim to assess the~     feasibility of implementing a T&F Registry in these high-risk hospitals by evaluating~     implementation effectiveness for that innovation. The investigators have recruited 10~     hospitals that serve large proportions of minority women with breast cancer. The~     investigators will randomize hospitals and aim to recruit 354 women with a new breast~     cancer, 177 per intervention arm. The investigators choose these high risk hospitals~     because they serve predominantly minority populations, and such hospitals have higher rates~     of the system failure cause of underuse, and particularly, the type of underuse targeted by~     our Tracking and Feedback Registry.~   "
115509|NCT01544361|"~     This is a Phase 1 study to evaluate the safety and tolerability of single ascending~     intravenous doses of MEDI7814 in healthy adult subjects.~   "
115510|NCT01544348|"~     Phase 1 study to evaluate the safety of MEDI4212.~   "
115511|NCT01544335|"~     The purpose of this study is to determine whether measuring the fluid in your arms using~     Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as~     measurements with the Perometer. The investigators will also evaluate any symptoms you may~     experience in your arms during and after treatment for breast cancer with a questionnaire.~   "
115512|NCT01544322|"~     The purpose of this study is to determine the tolerability of ME-344, find the maximum~     tolerated dose, and the safety profile in patients with refractory solid tumors.~   "
115513|NCT01544309|"~     The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid~     lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes~     mellitus.~   "
115514|NCT01544296|"~     This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and~     safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.~   "
115515|NCT01544283|"~     Objective:~      This purpose of this pilot study is to explore the potential usefulness of Synera for the~     treatment of pain associated with shoulder impingement syndrome.~   "
115516|NCT01544270|"~     The study aims to investigate the role of dietary factors in chronically stressed subjects.~     Previous studies have shown that milk proteins, B vitamins and probiotics may influence on~     subjective well-being in stressed subjects.~   "
115517|NCT01544257|"~     The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented~     and results from previous studies suggest the association between OMT and length of stay~     (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of~     the present study is to show the effect of OMT on LOS in a sample of premature infants.~   "
115518|NCT01544244|"~     The primary objective of this study is to demonstrate the superiority of the CGE physical~     therapy protocol versus a standard physical therapy protocol of the shoulder by measuring~     the following after 1 month of physical therapy: the FI2S score including validated measures~     of pain, glenohumeral joint range of motion in the three planes, the ability to perform~     certain everyday activities and the strength of forward elevation measured with a~     dynamometer.~   "
115519|NCT01544231|"~     This research project consists of a prospective diagnostic study conducted on patients with~     clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University~     Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main~     objective of this study is to determine whether the plasma level of Neutrophil Gelatinase~     Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF)~     occurring within 48 hours after admission for rhabdomyolysis.~   "
115520|NCT01544218|"~     Alcohol use is a serious health threat to the 26% youth in the US with chronic medical~     conditions. While alcohol use can significantly impact an underlying illness and its~     safe/effective management, medical specialists rarely screen their adolescent patients for~     alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18~     year old youth with chronic medical conditions. Comprehensive assessment information will be~     collected and analyzed to describe relationships between youth alcohol use, other substance~     use, and chronic disease outcomes and findings integrated into the validated screen as~     actionable clinician guidance and health advice.~   "
115521|NCT01544205|"~     The purpose of the study is to investigate whether neurofeedback delivered via functional~     magnetic resonance imaging signals can be used to train depressed patients to self-regulate~     emotion networks and whether this improves clinical symptoms.~   "
115535|NCT01543867|"~     This study is conducted in Europe. The aim of this study is to evaluate safety during the~     long-term use of somatropin (Norditropin®) in children as well as efficacy on change in~     height. A subgroup of children small for their gestational age is included.~   "
115536|NCT01543854|"~     This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute~     heart failure. In addition safety and effects on renal function and biomarkers will be~     assessed.~   "
115522|NCT01544192|"~     Background: The significance of retinal ganglion cell protection in the glaucoma led the~     view that, glaucomatous optical neuropathy can also be considered as a pathology of central~     nervous system. It is known that α−tocopherol and Gingko Biloba have specific~     neuroprotective and vasoregulatory activities, in addition to antioxidant effects. In this~     study, the investigators compared early neuroprotective effects of α−tocopherol and GB with~     each other as well as control and a strong antioxidant formulation in patients with~     glaucoma.~      Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were~     enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the~     controls, patients in the 3 antioxidant groups received α−tocopherol, Gingko Biloba and a~     strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as~     thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded.~     The data were compared statistically.~   "
115523|NCT01544179|"~     The purpose of this study is to assess the efficacy and safety of gefitinib in patients who~     have progressed on first line gefitinib, comparing continuing gefitinib in addition to~     cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed~     combination chemotherapy alone.~   "
115524|NCT01544166|"~     The main purpose of this study is to collect data on the way gadobutrol is taken into, moves~     around, and is eliminated from, the body of children aged 0 to less than 2 years. The study~     will also evaluate safety and tolerability, and efficacy of gadobutrol.~      A maximum total amount of approximately 5 ml of blood will be needed for these analyses~     which will be drawn within 2-3 days.~      Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI),~     potentially allowing better visibility of tissues in the body. Children aged under 2 years~     scheduled for a routine contrast-enhanced MRI examination of any body region may take part~     in this study, in which case they will receive gadobutrol as contrast agent intravenously at~     the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal~     insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age~     adjusted normal value calculated based on the Schwartz formula) will be included in the~     trial.~      The duration of this study as a whole is around 1 year and the total number of children to~     be enrolled is 50. A child will be expected to take part in the study for around 7 days.~   "
115525|NCT01543997|"~     The purpose of this study is to investigate clinical benefits of a novel sleep-focused~     mind-body program on Gulf War Illness (GWI) symptoms.~   "
115526|NCT01543984|"~     The purpose of this study is to test the effect of Tailored Physical Activity on the~     number of sick-days.~      The hypothesis is that Tailored Physical Activity is superior in efficacy on sick-days.~   "
115527|NCT01543971|"~     This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily~     injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.~      The aim of the study is to determine the safety of the TXA127 alone and in combination with~     Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen~     enhances peripheral blood stem cell (CD34+)mobilization.~   "
115528|NCT01543958|"~     HIV-infected people can have an increase in inflammation in their body organs, even after~     taking anti-HIV medicines.~      Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind~     endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients.~     Sevelamer carbonate decreases the inflammation endotoxin causes in dialysis patients.~      A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer~     carbonate administration on markers of microbial translocation and T-cell activation in the~     blood in chronically HIV-infected subjects not receiving ART.~   "
115529|NCT01543945|"~     The purpose of this study is to compare the incidence of Postoperative nausea and vomiting~     between the intervention group who received multimodal antiemetic management and the control~     group who did not get this protocol.~   "
115530|NCT01543932|"~     Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in~     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention~     (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet~     response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet~     reactivity [PR], variability of the drug metabolism, and various drug interactions) being~     implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a~     prospective, single-center, investigator-initiated, randomized, study to compare platelet~     inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day~     Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose~     of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and~     with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized~     (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or~     Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.~   "
115531|NCT01543919|"~     PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is~     associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to~     patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety~     and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)~   "
115532|NCT01543906|"~     The purpose of this study is:~        -  To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in~          RP subjects with an autosomal dominant mutation in RPE65.~        -  To evaluate duration of visual function improvement (if observed) in RP subjects with~          an autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.~        -  To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP~          subjects with an autosomal dominant mutation in RPE65.~   "
115533|NCT01543893|"~     Resistance training is widely used in training and rehabilitation. During recent years~     elastic resistance training has become increasingly popular for preventing or relieving~     neck/shoulder/arm pain among sedentary employees. While most research studies documenting~     positive effects of such interventions have used training instructors, most training in~     practice does not use an instructor but rather depends on information from other sources~     such as the internet. Here the investigators examine - in a outcome assessor blinded~     randomized controlled trial - the effect of 2 weeks elastic resistance training for the~     neck/shoulder/arm with personal versus video instruction on technical execution.~   "
115537|NCT01543841|"~     Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in~     healthy individuals and in people with cancer. These cells may play a role in the growth of~     blood vessels (veins/arteries), and may be particularly important in the growth of blood~     vessels that supply tumours. Understanding how these cells work may therefore help~     researchers to develop cancer treatments that starve tumors of their blood supply.~      This research study involves an analysis of the behaviour of blood cells in response to~     different drugs in a test tube. The goal is to develop tests that can then be used to~     monitor patients treated with drugs that target blood vessel growth.~   "
115538|NCT01543828|"~     This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in~     moderate-severe COPD patients with breathing symptoms to assess time to patient's perception~     of onset of effect.~   "
115539|NCT01543815|"~     The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this~     RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the~     gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients'~     management (CM) for psychological distress and promotion of healthy behaviors in Cardiac~     Patients.~   "
115540|NCT01543802|"~     The purpose of this study is to examine if a short-term treatment with pazopanib, an oral~     drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue~     sarcomas and thus facilitate their resection when given prior to surgery. Moreover, the~     study assesses the prognostic and predictive value of several new biomarkers (endothelial~     progenitor cells, soluble vascular epithelial growth factor),~   "
115541|NCT01543789|"~     The use of mesh in the repair of umbilical hernias is a gold standard. The best location of~     the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal~     cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so~     not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists~     of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory~     ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and~     subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and~     the surgery.~      This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene~     for preperitoneal use), will be used in this multicentric trial, to evaluate the best~     procedure in terms of efficacy, safety and postoperative complications.~   "
115542|NCT01543776|"~     This randomized phase II trial studies the best way to give abiraterone acetate in treating~     patients with castration-resistant prostate cancer. Abiraterone acetate is effective in~     treating castrate resistant prostate cancer and is taken in the fasting state. However, the~     body's absorption of abiraterone is increased with food intake. This study will test the~     whether a lower dose of abiraterone taken with food has a similar effect on prostate~     specific antigen (PSA) compared to full dose taken fasting.~   "
115543|NCT01543763|"~     This is a open-label non-randomized, dose escalation and expansion Phase Ia/b study to~     determine the safety, tolerability and maximum tolerated dose (MTD) of pazopanib in~     combination with PCI-24781 in patients with advanced solid tumors.~   "
115544|NCT01543750|"~     Episodic ataxia type 2 (EA2) is a rare familial neurological condition characterized by~     debilitating episodes of vertigo and imbalance. Since the serendipitous discovery of~     dramatic response of EA2 to acetazolamide, acetazolamide has been the first-line treatment~     for EA2. Yet, for those patients who do not respond to or cannot tolerate acetazolamide,~     there is no alternative treatment. The purpose of this randomized trial is to test whether~     4-aminopyridine may reduce the ataxia episodes in EA2 as an alternative to acetazolamide.~     Funding Source - FDA OOPD~   "
115545|NCT01543737|"~     The purpose of this study is to assess whether a single injection hyaluronic acid (HA)~     product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of~     effectiveness in reducing pain when walking in patients suffering from symptomatic~     tibiofemoral osteoarthritis of the knee.~   "
115546|NCT01543724|"~     The investigators will assess Li-induced gray matter volume changes with regard to the~     endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more~     attributable to neurotrophic and neuroprotective characteristics of Li, which were closely~     related to the inhibition of apoptotic activity of GSK3beta.~   "
115547|NCT01543711|"~     Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently~     occurring late effects of breast cancer treatment. The investigators have previously~     published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006.~     Very few studies have examined how these late effects change in time. The aim of this study~     is to examine in a well defined patient population any change in the prevalence of~     persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk~     factor profile.~   "
115548|NCT01543698|"~     This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate~     the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple~     combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part~     to assess the clinical efficacy and to further assess the safety of the combinations in~     selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous~     schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off~     schedule. Patients will be treated until progression of disease, unacceptable toxicity~     develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as~     28 days. The dose escalation parts of the trial will be conducted in adult patients with~     BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for~     the dual combination and at least 12 patients for the triple combination. The dose~     escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D~     declaration, patients will be enrolled in three Phase II arms for the dual combination and~     one Phase II arm for the triple combination. All patients will be followed for 30 days for~     safety assessments after study drugs discontinuation. All patients enrolled in the Phase II~     part of the study will be followed for survival.~   "
115549|NCT01543685|"~     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and~     effective for the treatment of postoperative bunionectomy pain.~   "
115550|NCT01543672|"~     Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer~     patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation~     study.~   "
115551|NCT01543659|"~     The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans.~     By improving our ability to find cancer cells, the investigators hope to be able to improve~     treatment for patients in the future.~      The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET~     scan, can specifically see prostate cancer that has spread to other parts of the body,~     especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts~     with the body and how long it stays in the body. The investigators will also ask the patient~     to have a biopsy performed. The study doctors will compare the findings the investigators~     see on the scans with findings on the optional tissue biopsy. Finally, the investigators~     will compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan~     (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans,~     depending on which standard scans the doctor has ordered.~      PET scanning uses a small amount of radiation attached to a molecule that is taken up by the~     cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is~     a standard tracer for PET scans. The patient will also undergo another type of PET scan that~     is experimental. This experimental PET uses a radioactive protein called J591. The radiation~     source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr,~     is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in~     a scan should find where the cancer is in the body.~   "
115552|NCT01543646|"~     The RIAL study aims to investigate whether non-invasive measurement of liver fat, iron~     content and fibrosis are as accurate as liver biopsy specimens in determining if patients~     have non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), or other suspected~     liver disease.~      Currently, the gold-standard for the diagnosis and staging of liver disease is a liver~     biopsy.~      In this study, consecutive patients will be offered a multiparametric MR scan to assess~     their liver while they await a liver biopsy.~      Study time-frame: The scan will be performed in the 6-week period before their biopsy, and~     results will be compared to biopsy findings. results will be presented at the end of the~     study when MR data outcomes are compared to gold-standard biopsy dat. Participants will only~     have to attend one study visit to participate - there will be no patient follow-up.~   "
115553|NCT01543633|"~     The purpose of this study is to investigate how the commonly used anesthetic drug propofol~     works in the brain to produce loss of consciousness. While under general anesthesia your~     brain waves will be measured using electroencephalogram (EEG). On a separate day, the~     patient's brain will be imaged using magnetic resonance imaging (MRI).~   "
115554|NCT01543620|"~     The project is designed to test new biomarkers that are more sensitive than the current~     standard in detecting injury to the proximal kidney tubule and will establish better~     criteria for when kidney safety concerns may halt further testing of a drug in humans.~   "
115555|NCT01543607|"~     Patients with malignant bile duct stenosis have poor prognosis and most of the patients are~     not good candidate for surgery at the time of diagnosis. Placement of the stent is the~     palliative care for these patients. However over 50% of the stents get blocked within 6-8~     months. Use of the radiofrequency ablation before the stent placement may improve stent~     patency. Heat will be applied to the bile duct in order to open the blockage and prevent the~     re-growth of tissue into the stent. The investigators are looking to see how safe and~     feasible RFA catheter is in patient with malignant bile duct stenosis.~   "
115556|NCT01543594|"~     The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a~     fundamental discovery to treat rheumatic patients whose disease appears to be refractory to~     conventional therapy. These biologic drugs have been registered for human therapy from a few~     years, thereby the investigators miss long-term data for safety and efficacy. Aim of this~     study is to register all the clinical data of patients with rheumatoid arthritis and~     spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term~     safety and efficacy in the real life.~   "
115557|NCT01543581|"~     The primary objectives of this study are to assess, using Mohs micrographic surgery (MMS) at~     the end of treatment, the efficacy (primary) and safety (secondary) of vismodegib compared~     to placebo in the oral adjunctive pre surgical treatment of basal cell carcinoma. A~     secondary objective is to assess how often and in what types of lesions does pre surgical~     treatment with vismodegib result in complete eradication of the tumor.~   "
115558|NCT01543568|"~     50 Patients with recalcitrant exudative age-related macular degeneration with a history of~     retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg~     and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of~     ranibizumab.~   "
115559|NCT01543555|"~     Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular~     complications. Statins have shown to lower cholesterol levels and reduce cardiovascular~     events in other scenarios. The objective of this study is to explore the effects of~     atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal~     Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo~     noncardiac surgery.~   "
115560|NCT01543542|"~     Helical tomotherapy is a novel radiation treatment machine that combines two existing~     technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy~     imaging of the body. This new machine can potentially allow radiation treatments to be~     focused more precisely, and delivered more accurately than with existing radiation machines.~     In this study, helical tomotherapy will be used to provide radiation treatments (whole brain~     radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to~     the brain. In addition, the individual spots of cancer (metastases) in the brain will be~     treated to a higher dose (approximately 2 times higher) than the dose to the whole brain.~     The purpose of this study is to determine the effectiveness of whole brain radiation with~     lesion boosting with the helical tomotherapy machine.~   "
115561|NCT01543529|"~     This single-center, randomized, double-blind, four-period crossover study will investigate~     the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy~     volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose~     of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and~     alcohol, and placebo to RO4917838 and non-alcoholic drink.~   "
115589|NCT01543165|"~     This study is to see whether the combination regimen of ketorolac and nefopam is superior to~     that of ketorolac and morphine in controlling ureter stone-related acute flank pain.~   "
115562|NCT01543516|"~     The aim of this case-control study is the comparison of the cell distribution in induced~     sputum in young adults with asthma and in healthy controls.~      The study consists of two visits. At both visits subjects are asked to perform a lung~     function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured.~     At the first visit a blood sample is drawn to determine the inflammatory and allergic status~     of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit~     another sputum sample is induced by a nozzle nebulizer. The cell distribution will be~     evaluated in both sputum samples.~   "
115563|NCT01543503|"~     This prospective, multi-center, observational study will assess the efficacy and safety of~     treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra~     (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.~   "
115564|NCT01543490|"~     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305~     (Dexamethasone in DuraSite®) compared to Vehicle in the treatment of subjects with~     Non-Bacterial Blepharitis.~   "
115565|NCT01543477|"~     The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA),~     neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with~     Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The~     other key objective of this study is to obtain information on adverse drug reactions (ADR)~     associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation~     and data on long term use.~   "
115566|NCT01543464|"~     The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance~     the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.~   "
115567|NCT01543451|"~     The main objective of this study will be to obtain data on the efficacy of elsiglutide in~     preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving~     5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.~   "
115568|NCT01543438|"~     The goal of this project is to develop the content and delivery platform that electronically~     distributes mobile video discharge education for underserved populations and to demonstrate~     utilization, satisfaction, and improved health outcomes.~   "
115569|NCT01543425|"~     Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in~     maintaining homeostasis. The literature reports that pain in patients treated with opioids,~     significant changes are taking place in this axis with a collapse in hormone concentrations~     that are correlated with the decline on tests of quality of life and psychological testing.~     The investigators hypothesis is that this endocrinopathy could also be present in patients~     treated for neuropathic pain with other drug classes as opiates (antidepressants,~     antiepileptics), and may explain, at least in part, the impairement of the quality of life~     of these patients.~   "
115570|NCT01543412|"~     No validated second-line chemotherapy for the treatment of locally advanced/metastatic~     pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or~     Oxaliplatin)-based regimen.~      Irinotecan seems to be a moderately active drug in the treatment of this disease Recently~     was reported some interesting results using a potentially non -cross resistant regimen~     (FOLFIRI) which could be useful even as second-line chemotherapy.~      An exploratory study in this setting seem warranted.~   "
115571|NCT01543399|"~     The interruption of the secretion of sex steroids occurring during menopause, causes a~     change in vascular pattern at various levels. As a result, several agencies have side~     effects that interfere with women's health. The use of hormone replacement therapy has~     contributed to the improvement in these effects. In previous studies the investigators~     showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens,~     medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal~     arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated~     Dilatation of the brachial artery.~   "
115572|NCT01543386|"~     The aim of this study is to determine if an oral loading-dose of curcumin can improve~     vascular endothelium reactivity in patients with moderate cardiovascular risk~   "
115573|NCT01543373|"~     The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting~     Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent~     (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical~     Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered~     to Total Stent Struts Per Cross Section) score ≤ 0.3.~   "
115574|NCT01543360|"~     The main objective of this study is to compare the rate of successful establishment of a~     central venous catheter in the first two attempts of ultrasound-guided puncture between two~     techniques: (1) a subclavian technique versus (2) an axillary technique.~   "
115575|NCT01543347|"~     This study is aimed at demonstrating the efficacy of temocillin in the treatment of~     complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases~     (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.~   "
115576|NCT01543334|"~     The primary objective of the DALI study is to compare antibiotic concentrations in patient~     blood samples with bacteriological objectives associated with maximum bactericidal activity.~     The antibiotics studied are certain lactams and glycopeptides.~   "
115590|NCT01543152|"~     The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral~     load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.~   "
115591|NCT01543139|"~     This proposed research is aimed to investigate the efficacy and safety of the creatine and~     cytidine augmentation in treating bipolar depression and to evaluate changes in relevant~     brain biochemical metabolism using magnetic resonance spectroscopy.~   "
115592|NCT01543126|"~     Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy~     correlate with the prognosis of the disease~   "
115602|NCT01542983|"~     Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect~     their mood, their memory and their quality of life. The investigators are testing whether it~     is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start~     of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and~     quality of life.~   "
115603|NCT01542970|"~     The incidence of allergic disease has increased worldwide during the last decades.~     Initially, a lot of effort has been put in elucidating which of the known risk factors~     commonly associated to the development of allergic disease early in life was the cause of~     this increase. Studies showing a reduced incidence of allergic disease in the former~     socialist countries in comparison to countries with a Western lifestyle have shown that~     risk factors as allergen exposure, environmental pollution and tobacco exposure are also~     present in societies with a less affluent lifestyle. This suggests the disappearance of~     factor protecting against the development of allergic diseases in affluent environment.The~     development of allergic diseases begins during the first year of life with eczema, both~     non-IgE- and IgE-associated, and food allergy, progressing during childhood with the~     development of asthma bronchiale, also both non-IgE- and IgE-associated, and later~     development of allergic rhinoconjunctivitis, i.e. the atopic march. The immune system of the~     neonate is influenced by maternal immunity, both via the placenta and breast milk. Thus, the~     immunological interaction between the mother and her offspring is close during pregnancy and~     lactation. The association of cord blood IgE levels with maternal but not paternal atopic~     heredity, may depend on a possibly stronger placental Th2 shift in atopic mothers. Thus,~     factors influencing/protecting against the development of allergic disease early in life,~     would be important already during pregnancy, birth and early postnatal life. Two major~     hypotheses have been assessed during the last decade: Proper microbial stimulation,~     including the establishment of the gut flora in infancy and the relationship between low~     omega 3-polyunsaturated fatty acids in the western diet and the incidence of allergic~     disease.~      This is a double blind randomized study. Families with at least one parent/sibling with~     clinical symptoms/history of allergic disease will be invited to participate in this study.~     Pregnant mothers will be included in the study at the 20th week of gestation. They will be~     randomized to 4 study groups, one will receive placebo capsules, the second will receive~     omega-3 PUFA supplementation and placebo regarding L. reuteri, the third will receive L.~     reuteri and placebo regarding omega-3 PUFA and the fourth group will receive both omega-3~     PUFA and L. reuteri supplementation. Omega-3 supplementation will be given to mothers from~     pregnancy and lactation while L. reuteri will be given to the mothers during pregnancy and~     later to the children during the first year of life.The children will be clinically followed~     by an allergy nurse regularly. Questionnaires regarding data on environment, siblings, pets,~     breast feeding, smoking exposure, upper respiratory and other infections and clinical~     symptoms of allergic disease will be filled regularly. Skin prick tests (SPTs) will be~     performed in the children at 6 and 12 months with milk, egg, wheat, peanut and cat. At 24~     months, timothy and birch allergen extracts will be added. A pediatrician will assess the~     children at 24 months of life and whenever it is needed during the study period. Dietary~     habits will be assessed during pregnancy (25th gestational week) and 6 months after child~     birth. Blood samples in the children will be taken from cord blood and at 6, 12 and 24~     months of life. Maternal blood samples will be taken at 20th weeks of gestation and at child~     birth. Milk samples will be collected 1-4 days after partus and monthly during the first 4~     months of lactation. Maternal gastrointestinal function will be addressed by validated diary~     cards. Saliva from the children and fecal samples from mother and child will also be~     collected according to the following protocol.~   "
115577|NCT01543321|"~     Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of~     abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least~     three months. This important public health issue arises for 15-20% of patients treated with~     neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and~     seriously impacts the patients' quality of life. In over 50% of cases, it is~     irreversible-that is to say that he will persist despite discontinuation of the offending~     drug.~      Risk factors have been described: the age and female gender are established, a higher dosage~     of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia~     are likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or~     powerful, longer term use of corrective treatments including anticholinergics are still~     discussed.~      Apart from preventive treatment, which consists in using antipsychotics as being coerced,~     support is disappointing: the etiological treatment, which is to stop the offending~     antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late~     irreversible. Must still have the possibility to interrupt the treatment, which is usually~     impossible in the risk of decompensation of the mental illness for which the neuroleptic was~     prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme~     cases, because it is not without risk, in terms of morbidity and mortality. So it's the~     medication that is most often offered: many drugs have been proposed, a direct result of the~     multiplicity of neurotransmitter systems implicated.~      However, in the vast majority of cases, this approach is disappointing not to say~     ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®.~     Empirically, neurologists specializing in pathology of the movement are almost unanimous:~     its efficiency is very good, with good tolerance. Some preliminary studies have reinforced~     this impression. However, their level of evidence remains low and that is why the~     investigators propose to implement a prospective multicenter clinical trial, double-blind~     with placebo which will include two groups of 27 patients.~   "
115578|NCT01543308|"~     The protein composition of HDL is complicated. The investigators have identified 40 distinct~     proteins associated with HDL by proteomics technology, and these proteins have been~     confirmed to be related to the function of anti-inflammation, anti-oxidation, improvement of~     endothelial function, inhibition of thrombosis and so on. And the investigators also found~     that the levels of some proteins in HDL changed in patients with coronary heart disease,~     compared with the healthy control group.~      So, this study is to conduct in the two following aspects: enlarge the sample size to verify~     the preliminary results to find new research ideas of pathogenesis and biomarkers for~     coronary heart disease; and study the changes of HDL protein composition in patients with~     coronary heart disease before and after statins treatment using proteomics technology in~     order to find the mechanism of statins pleiotropic effects and indicators for evaluating the~     treatment effectiveness.~   "
115579|NCT01543295|"~     This study has been designed to evaluate the performance of the Chembio Diagnostics Systems,~     Inc. DPP® Syphilis Screen and Confirm rapid test. The device is intended to qualitatively~     and simultaneously detect the presence of antibodies to Non-treponemal and Treponema~     pallidum antigens in whole blood (capillary and venous), serum or plasma.~   "
115580|NCT01543282|"~     This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles~     in consecutive patients.~      Summary~      Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration~     (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies~     comparing them regarding efficacy and feasibility are lacking.~      Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of~     the conventional 22 G compared with the 25 G needle.~      Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for~     inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant~     coagulopathy (APT < 50% or platelets < 50000/mm3), use of warfarin or other anticoagulants,~     use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent~     and pregnancy or suspected pregnancy will be excluded.~      Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to~     compare proportions. Continuous variables will be compared using Student´s t test. A~     two-tailed P values of less than 0.05 will be considered statistically significant. The~     diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity,~     specificity, positive predictive value and negative predictive value. An expected rate of~     85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a~     power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a~     15% difference in the rate of diagnostic yield.~   "
115581|NCT01543269|"~     This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1,~     following oral administrations in healthy volunteers.~      The study shall be divided into four plans as given below:~        1. Plan I: Single dose escalation trial~        2. Plan II: Multiple dose escalation trial~        3. Plan III: Food effect trial.~        4. Plan IV: Gender Effect trial.~      The safety and tolerability shall be evaluated using physical examinations, Standard~     laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG)~     and thyroid scanning. Spontaneously reported and solicited adverse events will also be used~     for safety parameters.~   "
115582|NCT01543256|"~     The purpose of this of this study is to compare the use of Self Expanding Metal Stents~     (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic~     pancreatitis as it pertains to stricture resolution rates, complication rates and number of~     ERCP procedures during 24 months.~      Statistical testing will be performed to determine if the rate of stricture resolution for~     the metal stent is non-inferior to the plastic stent group.~   "
115583|NCT01543243|"~     This study aims to examine~        1. the feasibility~        2. immediately~        3. long term effects on postural control and strength of mechanical SR-WBV intervention in~          a frail elderly population.~   "
115584|NCT01543230|"~     The primary objective of this investigation is to evaluate survivorship at ten years. For~     this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a~     constant 1% per year.~   "
115585|NCT01543217|"~     The aim of this study is to reduce the number of subsequent hospital admissions and/or~     emergency department (ED) visits for hospitalized patients with chronic obstructive~     pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management~     (RCP-DM) program compared to standard discharge instructions and planning.~   "
115586|NCT01543204|"~     This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who~     have lost a satisfactory response to adalimumab.~   "
115587|NCT01543191|"~     The purpose of this study is to determine whether PUR118 is safe and tolerable in a~     population of subjects with Cystic Fibrosis.~   "
115588|NCT01543178|"~     This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550~     mg three times a day in patients with IBS with diarrhea who respond to initial treatment of~     rifaximin 550 mg three times a day.~   "
115593|NCT01543113|"~     Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of~     cancer death in young patients. Until now, available therapies were few and unreliable, but~     recent understanding of melanomas' molecular pathways has improve their classification and~     new clinical strategies have been proposed.~      Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most~     frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic~     Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and~     Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the~     predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous~     Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex~     with four exons being affected leading to different mutations, which incidence and~     biological impact are less documented.~      BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets.~     Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E~     BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations~     modulate differently c-Kit function and the response to targeted therapies.~      Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to~     identify the most frequent mutations present in our population to propose appropriate~     screening test and adapt the therapy.~      Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population~     (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct~     sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR~     and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be~     analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in~     codon 12, 13 and 61 (Pyrosequencing).~      Expected Results:~      Taken together, the investigators anticipate that the present genetic analysis of the~     tumours from patients with advanced melanoma will first document the type and frequency of~     cKit mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually~     exclusive and document their repartition in the melanomas sub-types. Finally this study will~     clue researchers in to how well patients will respond to a therapy that targets the~     growth-promoting proteins BRAF/NRAS and cKIT.~   "
115594|NCT01543100|"~     Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the~     literature to be associated with vascular failures and dysfunction that reflect~     neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy~     patients although they significantly increase in several cancers including myeloma. However,~     no study explored to date a correlation of CEC and/or circulating endothelial progenitors~     (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is~     no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to~     evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal~     gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary~     multicentric study.~   "
115595|NCT01543087|"~     This study is a follow-up of Pfizer studies using rLP (treatment assignment known) and~     investigational product (treatment assignment unknown) in which the subjects will attend up~     to 6 study visits for collection of a 20-mL blood sample at each visit.~   "
115596|NCT01543074|"~     This pilot, three-week study will help scientists understand more about how the foods people~     eat can modify histone deacetylases, enzymes the body produces naturally. Broccoli sprout~     extract (BSE) and garlic oil are thought to modify these enzymes. The purpose of this study~     is to see if taking broccoli sprout extract alone, garlic oil alone, or broccoli sprout~     extract and garlic oil together, can decrease the action of histone deacetylase (HDAC) and~     turn on genes in white blood cells. There will be 80 people in this study.~   "
115597|NCT01543061|"~     The objectives of the investigation will be to assess the effect of the repeated usage of a~     new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with~     contact lens related comfort problems and to quantify any potential benefit.~   "
115598|NCT01543048|"~     CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They~     are subsequent to a persistent HPV infection and are classically treated by conization.~     Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2~     years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high~     risk women who might develop cervical cancer. Colposcopy and cytology have been recommended~     since 1989 by French ANAES, but these methods have poor sensitivity and specificity.~     However, DNA HPV testing is more sensitive and has demonstrated a very high negative~     predictive value, while specificity and positive predictive value remain average. Other HPV~     markers like genotyping, viral load and integration begin to be used in screening but have~     not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which~     predict CIN2/3 recurrence after conization. The primary objective is to describe HPV~     expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the~     follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression~     (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization,~     compared to the other clinical and virological risk factors.~   "
115599|NCT01543035|"~     Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL)~     cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in~     HIV-infected individuals, and has been associated with HIV infection itself and~     antiretroviral therapy (ART). These abnormalities are well-established markers of~     cardiovascular (CVD) risk in the general population. Studies have suggested an increased~     risk of CVD associated with ART exposure over and above that conveyed by traditional~     cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual~     clinical strategy remains to add a statin treatment.~      Recent studies suggested ART switch can represent an interesting alternative to statins to~     reduce lipid plasma levels.~      The purpose of this study is to evaluate the frequency with which the replacement of LPV/r~     (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV~     (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would~     obviate the necessity to administer statins.~      A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on~     antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.~      At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will~     replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore~     for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined.~     Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers~     will be measured at baseline, at drug switch and at the end of the study~      Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for~     study drug will be done at week-4 and week-12, Returned study medication will be counted and~     the amount notified on the Case Report Form (CRF).~   "
115600|NCT01543022|"~     The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter~     pulsation therapy for up to thirty (30) days to patients with chronic heart failure who have~     persistent worsening of their condition despite optimal medical therapy. Patients will be in~     New York Heart Association (NYHA) Class IIIb or IV heart failure and have exhausted all~     medical or surgical options.~   "
115601|NCT01543009|"~     The aim of this study is to determine if local application of heat increases the probability~     of insertion of peripheral venous catheter at the first attempt, reduces the time needed to~     obtain cannulation and maintains the analgesic effect of Emla in children undergoing~     peripheral venous cannulation and previously treated with local analgesia with Emla.~   "
115604|NCT01542957|"~     The purpose of this study is to determine the efficacy of a brief psychological intervention~     focused on the personal dilemmas identified for each depressive patient. For that, this~     intervention is combined to group cognitive therapy (an already proven efficacious format)~     and compared to cognitive individual therapy.~   "
115605|NCT01542944|"~     The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar~     version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of~     stem cells from normal sibling donors for allogeneic stem cell transplantation.~   "
115606|NCT01542931|"~     Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally~     advanced or aggressive cancers, and to improve the chance of eradication of the locoregional~     lesions by radical surgery and/or radiotherapy. However, there are still debates on the~     clinical value of induction chemotherapy for patients with advanced and resectable oral~     squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of~     TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with~     locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival~     rate, local control, and safety.~   "
115607|NCT01542918|"~     This is a Phase I study, which means that the goal is to see if the study treatment is safe.~     The purpose of this study is to test the safety of Lenalidomide at different dose levels,~     and to test the safety of Lenalidomide alone or in combination with Rituximab (also known as~     Rituxan®).~   "
115608|NCT01542905|"~     The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red~     Ginseng and examine changes in brain structure, function and metabolites. A total of 60~     healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group~     or placebo group. Individuals will be examined through clinical assessment,~     neuropsychological function tests and neuroimaging.~   "
115609|NCT01542892|"~     Several trials have found that nutritional supplementation can elicit an increased rate of~     skeletal muscle protein synthesis following a single bout of exercise in both young and~     older individuals. However, there have been no studies that have investigated if nutritional~     supplementation and exercise can cause a sustained increase in physical functioning and fat~     free mass, particularly in older adults with functional limitations. This study will compare~     the effects of a nutritional supplement versus a placebo on exercise training induced~     changes in physical functioning older adults who are at risk for mobility disability.~   "
115610|NCT01542879|"~     A research study on the diagnosis of spread of disease for children who have been diagnosed~     with solid tumors using a new whole body imaging technique and a new MR contrast agent~     (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a~     child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron~     Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG)~     scanning. The purpose of this study is to determine if newer imaging tests referred to as~     whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of~     the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The~     advantage of the new imaging test is that it is associated with no or significantly reduced~     radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole~     body MR and PET/MR will be compared with that of the conventional, standard imaging studies~     for tumor detecting.~   "
115611|NCT01542866|"~     This is a prospective pilot study to evaluate the usability and applicability of a self~     monitoring test of visual function with the handheld Health Management Tool (HMT) to~     remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential~     change in disease status.~   "
115612|NCT01542853|"~     MRI has shoved little correlation with the clinical finding during treatment of~     spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good~     as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better~     in predicting residual disease in patients with spondylodiscitis.~      Preliminary study.~   "
115613|NCT01542840|"~     The purpose of this study is to compare injecting local anesthetic (numbing medication) in~     different patterns around a major nerve in the leg. Patients who undergo surgery to the~     lower leg and/or foot are usually offered the option of a nerve block to help with pain~     control after surgery. A nerve block involves injecting local anesthetic (numbing medicine)~     by a nerve or nerves that provide sensation to the area where surgery will be performed. The~     local anesthetic (numbing medication) numbs up the area where the surgery is performed and~     helps decrease the amount of pain felt after surgery. The local anesthetic (numbing~     medication) can be injected in various patterns by a nerve, such as in one spot by a nerve~     or completely surrounding a nerve. The local anesthetic will be either injected around the~     sciatic nerve or will injected in a way that will split the sciatic nerve into the two~     component nerves that make it up, the tibial and sciatic, and surrounds each nerve.~      The hypothesis is that subjects in the group that local anesthetic is injected in a pattern~     that separates the sciatic nerve into the two component nerves may have a faster onset time~     of regional anesthesia and block success than subjects in the group that have the local~     anesthetic injected at around the nerve.~   "
115614|NCT01542827|"~     Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and~     tenderness of muscles and joints. However, double-blind randomized controlled trials are~     lacking. Here the investigators examine - in a double-blind randomized controlled cross-over~     trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol~     scent) on neck pain.~   "
115615|NCT01542814|"~     This image-acquisition study is designed to acquire the study image data and establish and~     document the clinical findings for each subject. The acquired data will be used to support~     FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital~     Mammography) and future regulatory submissions.~   "
115616|NCT01542801|"~     -  For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver~          cirrhosis, norfloxacin 400mg per day is a standard regimen.~        -  Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In~          addition, ciprofloxacin once weekly administration is more convenient and less costly.~        -  Therefore ciprofloxacin once weekly could be more useful if the the efficacy is~          comparable to norfloxacin once daily.~        -  This study aims to prove ciprofloxacin once weekly administration is as effective as~          norfloxacin once daily administration for the prevention of SBP in cirrhotic patients~          with ascites.~   "
115617|NCT01542788|"~     This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection~     who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants~     were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to~     match SOF+placebo to match RBV. Randomization was stratified by presence/absence of~     cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at~     screening.~   "
115618|NCT01542775|"~     The purpose of this study is to examine the effects of exercise on diverse cardiometabolic~     risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus~     (T2DM).~   "
115619|NCT01542762|"~     Currently, guidelines and clinical practice differ considerably with respect to use of~     anticoagulant treatment during cast immobilization of the lower leg. Trials that have been~     carried out were aimed at efficacy only, had small sample sizes and therefore mainly used~     asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could~     not be established, hence the current controversy. In the proposed study the investigators~     will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the~     investigators will follow subjects with an adverse event for a longer period, during which~     the investigators will assess the long term sequelae of these events. Lastly, the~     investigators will determine high risk groups that will benefit most from anticoagulant~     treatment.~      Objective: Comparative effectiveness research to determine cost-effectiveness of two~     existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg~     plaster cast immobilization following surgical or conservative treatment. In addition the~     investigators will investigate personalized prophylaxis based on genetic and acquired risk~     factors.~   "
115620|NCT01542749|"~     The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is~     based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In~     addition to calculating human blood volume it is hypothesized that measurement of the~     dilution of the tracer can also yield an accurate measurement of total body albumin.~   "
115621|NCT01542736|"~     To study the efficacy of the combination of reduced dose craniospinal radiation (reduced~     from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine~     administration for metastatic classical histology medulloblastomas and high-risk~     supratentorial PNETs and metastatic PNETs.~   "
115622|NCT01542723|"~     Currently, guidelines and clinical practice differ considerably with respect to use of~     anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out~     were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic~     thrombosis as endpoint. From these trials an overall risk benefit-balance could not be~     established, hence the current controversy. In the proposed study the investigators will use~     relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators~     will follow subjects with an adverse event for a longer period, during which the~     investigators will assess the long term sequelae of these events. Lastly, the investigators~     will determine high risk groups that will benefit most from anticoagulant treatment.~      Objective: Comparative effectiveness research to determine cost-effectiveness of two~     existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy~     of the knee. In addition the investigators will investigate personalized prophylaxis based~     on genetic and acquired risk factors.~   "
115623|NCT01542710|"~     The purpose of this study is to compare 2 fixed combination medications in intraocular~     pressure lowering.~   "
115624|NCT01542697|"~     intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and~     analgesic consumption in postoperative period following laparoscopic cholecystectomy.~   "
115625|NCT01542684|"~     The goal of this clinical research study is to learn if the combination of azacitidine and~     GM-CSF can help to control MDS. The safety of these drugs will also be studied.~      Azacitidine is designed to block certain proteins that stop the function of tumor-fighting~     genes. By blocking the bad proteins, the tumor-fighting genes may be able to work better.~      Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white~     blood cells. This may help to fight infections.~   "
115626|NCT01542671|"~     The primary objective of the study is to evaluate the effectiveness of tailored lifestyle~     intervention in primary care by comparing changes in the primary measure of weight and body~     mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and~     fruit/vegetable servings within the two arms (intervention and control) of the study. It is~     hypothesized that the intervention cohort will demonstrate greater reductions in body~     weight, body neglect, and fat calories consumed and greater increases in physical activity~     and fruits/vegetable servings after two years compared to the control cohort. The study also~     aims to evaluate and compare the cost of intervention for purpose per each unit of measure~     lost between the two arms of the study as a secondary objective. The cost of intervention~     will be evaluated as it relates to study replication.~   "
115627|NCT01542658|"~     This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy~     (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative~     variables and short-term outcome of RALM and TLM patients.~   "
115628|NCT01542645|"~     The primary aim of this randomized, double-blind study is to examine the effect of a single~     intraoperative dose of methadone on postoperative pain and analgesic requirements in~     patients undergoing cardiac surgery with cardiopulmonary bypass. These patients will be~     compared to subjects receiving a standard dose of the traditional intraoperative opioid~     (fentanyl). Secondary outcome measures to be assessed will include standard recovery~     variables (such as length of postoperative intubation, ICU length of stay, incidence of~     nausea or vomiting, level of sedation). In addition, patients will be assessed for the~     development of chronic postoperative pain.~   "
115646|NCT01542411|"~     This study evaluated the effect of anticoagulant treatment on the live-birth rate in women~     with a history of at least two continuous unexplained miscarriages or thrombophilia. It also~     compared two methods of treatment with aspirin and aspirin plus heparin.~   "
115647|NCT01542398|"~     The main research question of the study is whether a family-based, life-skills focused~     psychosocial intervention is effective in reducing psychological distress and stigma and~     improving inter-personal relations and functioning among war-affected children in the~     Democratic Republic of Congo.~   "
115629|NCT01542632|"~     A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose~     schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to~     compare the immunogenicity of different dose schedules of the vaccine.~      Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of~     viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then~     on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue~     neutralizing antibodies in serum were obtained at baseline [during the screening period or~     on day of vaccination (Day 0)], then on Days 30, 90 and 120.~      The entire duration for each individual subjects participation was approximately 5 months~     including recruitment and collection of data for primary outcomes (through Day 120).~   "
115630|NCT01542619|"~     This is a first in man, prospective, single-center, randomized, double-blind,~     dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of~     rVIIa-FP in comparison to placebo.~   "
115631|NCT01542606|"~     This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes~     into contact with vaginal secretions having an elevated pH level~   "
115632|NCT01542593|"~     Proper selection of ureteral stent length might help in reducing comorbidities associated~     with ureteral stenting, currently there is no standardized way of measuring ureteral length.~      Measurement of ureteral length according to Computed Tomography (CT) scan might provide~     useful information when selecting the length of a ureteral stent. Our aim in this study is~     to compare ureteral measurements using CT scan and measurement of actual ureteral length~     measured during ureteral stenting.~   "
115633|NCT01542580|"~     The purpose of this study is to evaluate performance of the Vanguard 360 revision knee~     system utilizing offset on either the tibial component, femoral component, or both in terms~     of the restoration of mechanical alignment, clinical outcomes and survivorship.~   "
115634|NCT01542567|"~     This study is designed to test the effectiveness of diclofenac suppositories in the~     prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.~   "
115635|NCT01542554|"~     The purpose of this study is to investigate the effect of low glycaemic diet on blood~     glucose control in Chinese type 2 diabetic patients.~   "
115636|NCT01542541|"~     Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG)~     that is taken-up by active cells such as cancer cells. This contrast can then be seen in the~     body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can~     produce false positive signals from the colon. Our hypothesis is that much of this signal~     comes from bacteria that are present in high concentrations in the colon. If this is the~     case, using an antibiotic to suppress the activity of bacteria may improve the ability of~     PET-CT to distinguish abnormal cells from normal cells in the colon.~   "
115637|NCT01542528|"~     The investigators are conducting this randomized trial to determine if IBBS (Integrated~     Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit~     Hyperactivity Disorder) in two culturally distinct settings; Hamden, Connecticut and~     Beijing, China. A subgroup of the children in Hamden will also participate in a brain~     imaging study before and after IBBS.~      IBBS combines computer-presented brain exercises with a physical education curriculum, all~     of which is designed to be fun, as well as to enhance sustained attention, inhibitory~     control and other executive capacities.~      IBBS is a school-based program in which groups children (composed of children with ADHD,~     children at risk for ADHD, and typically developing children) alternate between a classroom~     setting and the gymnasium four days a week for 15 weeks. These mixed age groups will be~     composed of children with ADHD, children at-risk for ADHD, and typically developing~     children. Although IBBS takes place in a group setting, the computer game component~     individualizes instruction to maximize benefit for each child.~   "
115638|NCT01542515|"~     Hypothesis:~      The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for~     the surgical treatment of basal joint arthritis of the thumb.~      A variety of surgical procedures have been developed for the treatment of basal joint~     osteoarthritis of the thumb. Problems with persistent pain and poor function have been~     reported to some degree for each of these procedures. Using the concept of an implant acting~     as a spacer and stabilizer the investigators proposed and implemented a novel surgical~     technique using allograft knee meniscus as a biologic implant for the treatment of basal~     joint arthritis of the thumb.~   "
115639|NCT01542502|"~     This will be a randomized, double-blind, crossover pilot study to measure the safety and~     feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart~     failure with preserved ejection fraction.~   "
115640|NCT01542489|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of~     Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic~     events in insulin treated subjects with type 1 or type 2 diabetes.~   "
115641|NCT01542476|"~     This study is conducted in Europe. The aim of this study is to assess the well-being of~     patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type~     2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting~     basal insulin analogue is needed.~   "
115642|NCT01542463|"~     This study conducted in Europe. The aim of this study is to evaluated the use of insulin~     detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.~   "
115643|NCT01542450|"~     This trial is conducted in Japan. The aim for this trial is to investigate the~     pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese~     subjects with type 1 diabetes mellitus.~   "
115644|NCT01542437|"~     Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line~     chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status~     were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were~     measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes~     in serum HGF levels and their association with objective response rate (ORR), PFS and~     overall survival (OS).~   "
115645|NCT01542424|"~     This trial is conducted in Europe. The aim of this trial is to investigate efficacy and~     safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects~     with type 1 or 2 diabetes mellitus.~   "
115648|NCT01542385|"~     The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined~     with adjunctive anticoagulation is superior to immediate stent implantation at improving~     cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial~     Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined~     with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined~     occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and~     target vessel revascularization at 90 days.~   "
115649|NCT01542372|"~     This project aims to investigate the efficacy of two models to treat Posttraumatic Stress~     Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is~     giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine~     reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those~     patients who still have PTSD, the second step is either another medication or a culturally~     sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients~     will improve in both models, but more so in the the CBT model.~   "
115650|NCT01542359|"~     The proposed study will compare a well defined and integrated yoga practice (postures/breath~     control/meditation) to a conventional exercise program in reducing hypertension. The~     expected outcomes include data on the effects of yoga on ambulatory blood pressure,~     psychosocial stress, and the autonomic system in individuals with pre- and Stage I~     hypertension. The information gained in this study will have a positive impact by providing~     critical preliminary and feasibility data to support a larger multi-ethnic randomized~     clinical trial on the effects of yoga on individuals with hypertension.~   "
115651|NCT01542346|"~     This is a double blinded randomized study investigating if subcutaneous adaption has an~     impact on cosmetic outcome after Caesarean delivery.~   "
115652|NCT01542333|"~     RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory~     may help doctor learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms~     tumor.~   "
115653|NCT01542320|"~     The purpose of this study is to understand how a probiotic might change the immune response~     of healthy infants.~   "
115654|NCT01542307|"~     This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in~     acute migraine headache.~   "
115655|NCT01542294|"~     The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin~     combination chemotherapy based on the adverse events and survival period by performing a~     phase I/II study of this combination in patients with D2 resection of gastric cancer.~   "
115656|NCT01542281|"~     1. To determine whether a combined nutritional support program and exercise-based~          prehabilitation is superior to nutritional support alone in increasing functional~          recovery and reducing post-operative morbidity after surgery for HPB malignancy.~        2. To understand which measures of immediate surgical recovery are sensitive to~          prehabilitation interventions and predict change in later outcome measures.~   "
115657|NCT01542268|"~     The purpose of this study is to determine the therapeutics effectiveness of oral~     pentoxifylline treatment in patients with IBS.~   "
115658|NCT01542255|"~     SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low~     Dose Vinblastine, Cyclophosphamide, and Dacarbazine.~      Patients with measurable metastatic melanoma are eligible. All patients will be treated as~     outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will~     be treated continuously, until evidence of progression of disease, or for up to two cycles~     following disappearance of all disease. A cycle will be defined as three weeks of continuous~     therapy with a one week rest.~   "
115659|NCT01542242|"~     Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in~     patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive~     effect and has been associated with weight loss in patients with type 2 diabetes.~     Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See~     attached Citation). In this case report, the subject showed improvements in hemoglobin A1c~     and body weight over 14 weeks.~      The investigators plan to examine the use of liraglutide in a single subject with Prader~     Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical~     parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid~     control.~   "
115660|NCT01542229|"~     As in the general population, there is no clear standard of care within Veterans Affairs~     Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with~     severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic~     stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among~     Veterans and this symptom presentation clearly exacerbates the overall course and severity~     of mental illness. This study is significant in that it proposes to establish the efficacy~     of a frontline exposure based intervention for posttraumatic stress disorder (PTSD),~     Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes~     among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it~     is anticipated that these data will establish a much needed clinical course of action for~     what is considered a vulnerable yet highly underserved patient population.~   "
115661|NCT01542216|"~     With the increased success in breast cancer therapies, survivors develop unhealthy changes~     in body composition, such as muscle loss and fat gains, which lead to increased risk of~     cardiovascular disease and diabetes in survivorship. This study will examine the effects of~     a nutrition, cardiovascular and strength exercise program compared with a yoga program~     (representing usual care) on body composition and metabolism in recently diagnosed breast~     cancer patients. Nutrition and exercise may improve various body composition and metabolic~     parameters, which may improve quality of life in survivorship, reduce risk of recurrence and~     reduce the risk of developing cardiovascular disease and diabetes in survivorship.~   "
115672|NCT01542073|"~     This is an open-label PET/CT (positron emission tomography/computed tomography) study to~     investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of myocardial~     infarction. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be~     intravenously injected into myocardial infarction patients. Visual and semiquantitative~     method will be used to assess the 68Ga-BNOTA-PRGD2 PET/CT cardiac images and compared to the~     99mTc-MIBI SPECT myocardial perfusion images and the 18F-FDG metabolism images.~   "
115662|NCT01542203|"~     This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This~     study is designed to measure drug concentrations in the blood of 18 female breast cancer~     patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute~     infusion) as part of standard medical care. Up to a total of 40 adult female participants~     will be consented for the study at the cancer center. Eighteen of these participants are~     needed to complete the study. The others will likely be screen failures. The participants~     will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just~     prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h~     after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The~     intravenous catheter will be removed when the participant is discharged from the cancer~     center on day 1. The participant will be asked to return to the cancer center at 12-24 and~     24-72 hours to have the final 2 blood draws conducted. The participants must be treated with~     Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis~     study.~   "
115663|NCT01542190|"~     The purpose of this study is to compare effects of preoperative and postoperative use of~     topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.~      Patients scheduled to undergo phacoemulsification will be randomized to receive either~     topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID~     (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID~     (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary~     outcome 5 weeks after surgery will be angiographic cystoid macular edema.~   "
115664|NCT01542177|"~     This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer~     using an imaging test called positron emission tomography (PET). Hypoxia can influence how~     pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy.~     The use of PET scans to measure hypoxia may be better and simpler than the approaches used~     previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA~     (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic~     cancer. Also as part of the study, a blood sample will be taken to study biomarkers~     (substances in the body that may be important indicators of hypoxia and/or pancreatic~     cancer) that may be useful in studying pancreatic cancer and hypoxia.~   "
115665|NCT01542164|"~     The overall purpose of this study is to examine the effect of calcium on fecal fat and~     energy excretion.~   "
115666|NCT01542151|"~     This randomized clinical trial will examine if there are any differences between post-dates~     inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the~     evening for first-time mothers. Sleep and fatigue measures will be measured to see if they~     differ by time of induction. Other measures will include the rate of births within 24 hours~     of admission, length of labor, use of labor analgesics, and method of delivery.~   "
115667|NCT01542138|"~     Axillary hyperpigmentation is a frequent consultation in dark skin populations although its~     exact prevalency is unknown. Currently, there are not studies about physiopathology and~     treatment for this entity. The objective is to evaluate the depigmenting effect of topical~     4% niacinamide versus 0.05% desonide in axillary hyperpigmentation.~      At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50~     years are going to be randomly assigned to receive niacinamide, desonide or placebo daily.~     No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9~     weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as~     Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.~   "
115668|NCT01542125|"~     The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation,~     occurs once adequate bone healing has taken place. At the Stollery Children's Hospital~     (SCH), this frequently performed procedure is currently done without anesthetic, making it a~     painful and uncomfortable experience for the child and their caregiver(s). Liposomal~     Lidocaine is a relatively new effective and needle-free topical anesthetic. The~     investigators were interested in examining its effectiveness in pain reduction in children~     undergoing Perc Pin removal. Objective: To determine if Liposomal Lidocaine is effective in~     reducing pain in a pediatric population undergoing Perc Pin removal compared to a placebo.~     Hypothesis: The investigators hypothesize that Liposomal Lidocaine would significantly~     reduce pain during Perc Pin removal compared to a placebo. Research Design: This was a~     triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients~     each in the Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher~     Scale (children) and a 10-cm Visual Analog Scale (parents and caregivers) were collected~     prior to randomization and immediately after Perc Pin removal. Data was analyzed using a~     Student's t-test and the Wilcoxon signed ranks test.~   "
115669|NCT01542112|"~     This new model to manage patient expectations was developed based on our international study~     conducted in four countries. The model is designed to address the main issues that lie at~     the core of initiatives to manage patient expectations and improve patient satisfaction. It~     is a structured interventional set of activities, which gives the clinician an opportunity~     to meet patient expectations and needs and thereby, improve patient satisfaction.~      The interventional model comprise teachable-learnable communicative steps occurring between~     the clinician and the patient which are: Gather information on the patient's expectations~     and perception of the hospitalization, Respond, Provide relevant information and Document~     the intervention.~      The intervention includes all frontline care givers; however, most of the activities will be~     done by the nursing staff. The set of activities will be executed by the nurses at three~     separate periods of time during the patient's hospitalization: time of admission,~     intermediate time and at time of discharge.~      The study is based on the hypothesis that a structured interventional model will~     significantly improve patient satisfaction during hospitalization.~   "
115670|NCT01542099|"~     The purpose of this study is to evaluate the effect site concentration of remifentanil~     blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.~   "
115671|NCT01542086|"~     The investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in~     patients with intermediate pre-test probability of CHD. To this end, patients with~     intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and~     myocardial SPECT. The patients will be analyzed for cost and also, for outcome.~   "
115674|NCT01542047|"~     This study is designed to investigate the possibility that use of two similar but distinct~     drugs used together in treatment of advanced cancer might prove less toxic than either agent~     used alone, because dosages can be reduced for each agent. This is a phase I study that is~     designed to measure the frequency and levels of specific side effects when Carboplatin and~     Pazopanib are used in combination in advanced cancer patients. The possibility that~     anti-tumor activity will occur is also going to be investigated.~   "
115675|NCT01542034|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
115676|NCT01542021|"~     Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone~     levels in the body.~      Degarelix is commonly given with radiation for prostate cancer, but less frequently with~     surgery since there has been no proven benefit with this approach.~      The investigators do not expect the patient to benefit directly from treatment with~     degarelix since their prostate will be removed shortly after the drug is given. Instead, the~     investigators hope to learn about how degarelix and other treatment that lowers your~     testosterone effects prostate cancer cells and use this information to develop better~     treatments in the future.~   "
115677|NCT01542008|"~     Bipolar disorder (BD) is a serious and chronic mental illness that is associated with~     substantial impairment in quality of life and functional outcomes, high rates of suicide,~     and high financial costs. In spite of a proliferation of treatments for BD, nearly half of~     individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication~     treatment adherence. Non-adherence with BD medication treatment dramatically worsens~     outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it~     has been suggested that adherence enhancement might work best if the intervention~     specifically addresses factors that are important and modifiable for a specific individual.~     In spite of the enormity of the problem, the literature on interventions to improve~     treatment adherence is surprisingly limited. There is an urgent need for interventions to~     enhance treatment adherence among BD patients that: 1) are at high risk for future treatment~     non-adherence; 2) may not have access to or interest in long-term, high-intensity, and~     specialized care; and 3) are flexible and patient-focused taking into account reasons for~     non-adherence for a specific individual.~      The proposed study is a first-ever RCT focused specifically on BD treatment adherence~     enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial~     intervention improves adherence and mental health outcomes compared to broadly-directed,~     non-individualized education (EDU). The proposed project has the potential to greatly~     advance the care of BD patients who are at greatest risk for poor health outcomes, with~     findings expected to be generalizable across a variety of treatment settings.~      Hypothesis 1: CAE will be associated with greater improvement in treatment adherence~     compared to broadly-directed, non-individualized BD education (EDU).~      Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.~   "
115678|NCT01541995|"~     The study aims to compare the value of contrast medium enhanced post mortem CT to classic~     autopsy.~   "
115679|NCT01541982|"~     The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for~     quality control in intensive care medicine.~   "
115680|NCT01541969|"~     The purpose of this study is to determine whether a new device delivering a sound-based~     intervention (termed acoustic coordinated reset neuromodulation) has significant clinical~     benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern~     of sound stimulation delivered by the device acts to break up patterns of synchronous nerve~     firing in the brain that may be responsible for the sensation of tinnitus. We will also~     measure brain activity in a subset of participants to determine if the intervention results~     in changes in brainwave activity.~   "
115681|NCT01541956|"~     This is an open-labeled, randomized, multicenter, prospective, parallel group,~     interventional study to demonstrate the effectiveness of 24 weeks treatment with~     Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg~     bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage~     metformin monotherapy.~   "
115682|NCT01541943|"~     The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with~     essential hypertension and hyperlipidemia~   "
115683|NCT01541930|"~     This clinical trial objective is to investigate the safety and efficacy of GK567 to~     alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours,~     over 14 days of treatment.~      The clinical hypothesis is that the success rate is no worse than 70% in the population of~     interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of~     treatment, as assessed by the Study Investigator.~   "
115684|NCT01541917|"~     The purpose of this multi-site randomized clinical trial is to determine if an online coping~     skills training program will produce superior improvements in pain and health-related~     quality of life outcomes for adolescents with JIA relative to outcomes attained with~     reviewing online educational information about JIA.~   "
115685|NCT01541904|"~     The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118~     ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal~     (SAC) and perennial (PAC) allergic conjunctivitis.~   "
115686|NCT01541891|"~     The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic~     solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms~     of mild-to-moderate dry eye syndrome.~   "
115687|NCT01541878|"~     Breast cancer is the most common malignancy affecting women. It is the second leading cause~     of cancer related death in women in many parts of the world. Breast cancer also occurs in~     men, accounting for nearly 1% of the total incidence. As a result of continuing research~     into new treatment methods, women and men with breast cancer now have more treatment~     options, and a better chance of long-term survival than ever before.~      The primary treatment for breast cancer is surgery. Early stage breast cancer, defined for~     the purposes of this registry as newly diagnosed, clinical stage I to IV breast cancer with~     no prior therapy for current disease, is often curable with surgery alone. Reports from the~     National Surgical Adjuvant Breast and Bowel Project (NSABP) and the European Organization~     for Research and Treatment of Cancer (EORTC) longitudinal trials have explored the efficacy~     of various surgical techniques as primary treatment of early stage breast cancer1-7. These~     studies include 20 years of follow-up data that have not shown any significant differences~     in overall survival or in rates of distant recurrences in women who underwent~     breast-conserving surgery with radiation therapy versus those who underwent mastectomy. The~     results of these studies have supported the use of surgery as the standard breast cancer~     treatment practice around the world.~      Data have shown that regardless of the surgical procedure selected for the removal of the~     primary tumor, micrometastases may be present and lead to the development of disease~     relapse. In order to decrease the risk of recurrence, patients may receive various~     therapies. Systemic treatments include chemotherapy and hormonal therapy. Local treatment,~     such as radiotherapy, can also be used to eliminate malignant cells that remain in the~     breast, chest wall, or lymph nodes after surgery.~      The selection of systemic therapy is a complex process, which is based partly on prognostic~     factors such as lymph node status, and predictive factors such as hormone receptor status. A~     number of additional factors are emerging such as HER2/neu overexpression8-10, p53 status,~     histological evidence of vascular invasion, and quantitative parameters of angiogenesis, but~     these await confirmation by further research11. However, patient age, socioeconomic status,~     and availability of treatment options are among a number of other factors that may play a~     role in determining the type of therapy that a patient is offered.~      Over the years, results from a large number of clinical trials have led to the development~     of various guidelines for breast cancer therapy, including the Early Breast Cancer Trialists~     Group (EBCTG) conferences in 199512 and 200013, the 2000 National Institutes of Health (NIH)~     Consensus Conference14, and the 8th St Gallen meeting in 200315. Despite the overview~     analyses and consensus recommendations, detailed information is lacking regarding the actual~     use of the currently available breast cancer treatments. Furthermore, the reasons that~     patients and physicians choose specific therapeutic regimens are not well understood.~      With more than 1.2 million people worldwide diagnosed with breast cancer in 200116, and the~     incidence predicted to increase, making appropriate treatment choices is critical to each~     breast cancer patient's survival, well-being and quality of life. The plethora of available~     scientific and lay information can result in a complex and arduous decision-making process~     for the breast cancer patient and his/her health care provider(s). It is anticipated that~     this registry will assist in the decision-making process by providing up-to-date information~     about treatment patterns.~      STUDY OBJECTIVES The purpose of the study is to collect, analyze, and disseminate data on~     patients with stage I-IV breast cancer. The goal of this registry is to improve patients~     care through a better understanding of treatment patterns and outcomes within individual~     countries, geographic regions, and ultimately, worldwide.~      Primary Objectives:~        -  Characterize the clinical pattern of patients with breast cancer (clinical stage I-IV~          as defined by the AJCC17).~        -  Characterize existing and evolving practice patterns.~        -  Assess patient disease free and overall survival outcomes.~      Secondary Objectives:~        -  Disseminate findings through publication in peer-reviewed scientific journals.~        -  Provide supportive data to the development of standard therapies.~        -  Analyze data and design ancillary studies to address unanswered clinical questions.~   "
115688|NCT01541865|"~     The Study objective is to assess the performance of the Vessix V2 Renal Denervation System~     for the treatment of uncontrolled hypertension using an innovative percutaneous Radio~     Frequency (RF) balloon catheter renal denervation device.~   "
115689|NCT01541852|"~     The main purpose of this study is to determine the effect of Losmapimod on blood vessels in~     patients with Chronic Obstructive Pulmonary Disease (COPD). Although COPD is a lung disease,~     it is also associated with an increased risk of cardiovascular disease (e.g. heart attacks~     and stroke). The investigators believe that this is a result of inflammation within the~     body, which damages the lining (endothelium) and walls of blood vessels. These changes can~     promote the development of fatty deposits within the walls of arteries (atherosclerosis)~     which can rupture and block arteries causing damage.~   "
115690|NCT01541839|"~     The primary objective of this study is to determine if there is a time savings in the~     operating room by using a septal stapler instead of suture in closure of primary~     septoplasty.~      The secondary objectives are to determine the subjective outcome of patients undergoing~     closure with the septal stapler instead of suture via questionnaire, and to determine if~     there is a difference in postoperative complications between groups.~   "
115691|NCT01541826|"~     The purpose of this project is to determine whether chokeberry polyphenols mitigate~     cardiovascular disease risk in former smokers.~   "
117283|NCT01520870|"~     This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety~     of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene~     amplification and/or EGFRvIII mutation.~   "
115692|NCT01541813|"~     Chronic iron overload is responsible for morbidity and mortality. There are many genetic and~     acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone~     for iron. The study explores this specific cause, and aim to characterize this iron overload~     in term of clinical, biological, genetic and functional specificities.~   "
115693|NCT01541800|"~     MicroRNAs are small molecules which have recently been discovered in cells. They are known~     to be responsible for the normal development of cells and when they are disrupted can~     contribute to the development of cancer. Many previous studies have been done evaluating the~     expression of microRNAs in normal tissues as well as a wide variety of cancers.~      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients~     with cancer. This presents a novel opportunity to use microRNAs in the blood as an early~     predictor of cancer as well as a marker of response to therapy. No previous studies have~     been performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with~     childhood cancers. We propose a feasibility study to evaluate the presence of microRNAs in~     the blood and cerebrospinal fluid of patients with central nervous system tumors, leukemia~     and lymphoma who are currently on chemotherapy and undergoing blood draws, lumbar punctures~     and/or reservoir taps for routine clinical care. If we're able to identify circulating~     microRNAs in this population of pediatric patients, we will build upon this data in~     proposing a future study.~   "
115694|NCT01541774|"~     The purpose of this study is to evaluate the procedural safety and effectiveness of the~     Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic~     lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is~     intended for use in atherectomy of the peripheral vasculature. The intended peripheral~     vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system~     is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of~     this study will be used to support a 510(k) submission to the Food and Drug Administration.~   "
115695|NCT01541761|"~     The proposed study is a randomized controlled trial to test the effectiveness of a primary~     care, family-centered child obesity prevention program beginning in pregnancy and continuing~     throughout the first three years of life compared to routine standard of care. The study~     aims to reduce the prevalence of obesity at age three, improve child diet composition and~     healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical~     center serving primarily low-income immigrant Latino families. The intervention Starting~     Early will consist of three components. 1) Family Groups: interactive groups coordinated~     with the child's primary care visits and led by a Nutritionist/ Child Developmental~     Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will~     be incorporated into family group discussions. 3) Plain Language Handouts: given to~     reinforce the curriculum from the family groups.~      Hypothesis: Compared to controls, the intervention group will show reduced obesity and~     improved parent feeding knowledge and increased healthy feeding attitudes, styles and~     practices~   "
115696|NCT01541748|"~     This study is a prospective, single arm, multi-center, post-market study to evaluate the~     efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and~     posterior) pelvic organ prolapse repair.~   "
115697|NCT01541735|"~     The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in~     drug-naïve patients with type 2 diabetes.~   "
115698|NCT01541722|"~     The primary purpose of the proposed study is to characterize the oxidative stress and~     inflammatory cytokine status in UCD during baseline and decompensated states.~   "
115699|NCT01541709|"~     KIT exon 9 mutants had poorer survival compared with KIT exon 11 mutants when they were~     treated with the same dose of imatinib, 400 mg per day, and that patients with KIT exon 9~     mutation had better progression-free survival with imatinib treatment at an escalated dose,~     800 mg per day, than with imatinib treatment at a dose of 400 mg per day.10,11 Based on the~     results, imatinib 800 mg per day is now considered the standard dose for the treatment of~     patients with metastatic or unresectable GIST showing KIT exon 9 mutation in Western~     countries.~   "
115700|NCT01541696|"~     The broad objective is to improve zinc status in older infants and young children who are at~     risk of zinc deficiency because of combination of inadequate dietary zinc intake and high~     rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the~     proposed study will measure the amount of zinc absorbed from a test meal of typical~     unfortified complementary foods consumed by Pakistani infants, or the same complementary~     foods fortified by the addition of the Zn-containing Sprinkle.~   "
115701|NCT01541683|"~     The investigators aim is to study the efficacy of mentholyptus drops in improving the~     palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study~     is a randomized controlled trial which will include patients undergoing elective colonoscopy~     at the American University of Beirut Medical Center. Patients will be randomized into one of~     two study arms using a computer generated randomization list. Patients assigned to the~     intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while~     drinking the PEG solution unlike the control arm patients who will only receive the PEG~     solution. All patients will then be evaluated for the tolerability of the preparation while~     taking into account the palatability of the solution as main outcome and the remaining~     volume of the PEG solution and side effects as secondary outcomes.~   "
115702|NCT01541670|"~     The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody~     in subjects with lupus nephritis.~   "
115703|NCT01541657|"~     The purpose of this study is to determine the effect of 3 types of sensory-targeted~     rehabilitation interventions on subjective and objective measures of function for those with~     chronic ankle instability. The investigators hypothesize that subjective and objective~     measures of function including self-reported disability, balance, and range of motion will~     improve after 2-weeks of sensory-targeted interventions.~   "
115717|NCT01541475|"~     The current study is being conducted in patients with major depression. The study aims to 1)~     investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and~     bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue,~     hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes~     using magnetic resonance imaging (MRI), 3) and examine a relationship between the~     improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.~   "
115704|NCT01541644|"~     Patients are asked to be in this study if they have multiple myeloma and are having~     tingling, numbness and pain from taking bortezomib (velcade®). Patients who have been~     diagnosed with multiple myeloma often take bortezomib (velcade®).~      This research is being done to find out if acupuncture can reduce the nerve pain, tingling,~     and/or numbness patients experience due to bortezomib (velcade®).~      Acupuncture is a medical technique of inserting very thin needles into the energy points~     on the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can~     be used to ease nerve pain and tingling, numbness that is caused by bortezomib.~   "
115705|NCT01541631|"~     In this study, it is hypothesized that helminth infections modulate immune responses against~     HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS~     and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of~     helminth infections on progression of HIV-1 infection is dependent on helminth infection~     intensity, host background immunity, nutritional status, demographic factors and~     socio-economic status. Also, treatment of helminth infections using praziquantel and~     albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads,~     improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and~     reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1~     infection is associated with poor anthelminthic treatment outcome as compared to non-HIV~     infected individuals~   "
115706|NCT01541618|"~     The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients~     before and after beginning Natalizumab.~   "
115707|NCT01541605|"~     This study aims at evaluating the efficacy and safety of methylphenidate in the initial~     treatment of acute mania in patients with bipolar affective disorders.~   "
115708|NCT01541592|"~     It has been shown that intravenous fatty acids given to normal volunteers in the form of~     heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is~     not known if this same phenomenon can be demonstrated with oral fat. The investigators are~     specifically interested in whether or not there are differences in the induction of insulin~     resistance between the 3 main classes of fatty acids (saturated, monounsaturated and~     polyunsaturated).~      The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of~     which frequently accompany insulin resistance.~   "
115709|NCT01541579|"~     The current multicentre phase III study is proposed to confirm in an add-on therapy design~     compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from~     healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease~     over a 24-week period and an extended follow-up period up to 104 weeks.~   "
115710|NCT01541566|"~     The purpose of this study is to assess whether, in patients at high cardiovascular risk~     (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most~     effective when based on home blood pressure telemonitoring and on the feedback to the~     patient by the doctor between visits, or when based only on blood pressure determination~     during quarterly office visits.~   "
115711|NCT01541553|"~     The purpose of this trial is to compare the rate of complete clearance of actinic keratosis~     (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to~     cryotherapy alone.~   "
115712|NCT01541540|"~     This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects~     will continue with their prescribed medications. Our main objective is to assess whether~     preventive e-counseling (provided through a website of the Heart and Stroke Foundation)~     improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will~     also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and~     adherence to prescribed medications. Finally, we will quantify the amount of e-counseling~     support that is required during REACH to evoke a significant reduction in blood pressure. It~     is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure~     and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide~     information that is critical to our understanding of how internet-based programs can help to~     improve blood pressure and to reduce the risk for cardiovascular disease.~   "
115713|NCT01541527|"~     Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication~     in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the~     molecule are named inhibitors whereas Abs directed towards non-functional epitopes are named~     non-neutralizing antibodies (NNA). These NNA are poorly studied and their prevalence is~     ill-defined.~      In a recent retrospective study the investigators evaluated, in a cohort of 210 patients~     without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy~     chain (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based~     assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC,~     the second to display Abs directed towards the B domain. NNA were found in 38 out of 210~     patients (18).~      Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both~     chains. The proportion of NNA directed towards the B domain was 18%.~      Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe~     HA patients, approximately 50% of severe HA patients develop an immune response against~     infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the~     routine clinical practice.~      However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the~     variations in the kinectics of FVIII observed in certain patients.~      The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not~     still been demonstrated.~      The investigators propose to perform a multicentre prospective study with the aim to~     confirm, in severe, moderate and mild HA treated patietns, the NNA prevalence observed in~     our retrospective study, to study the evolution over time of the epitopemapping of these NNA~     and to explore the correlation between these NNA and clinical/biological parameters.~   "
115714|NCT01541514|"~     The overall purpose to the study is to prospectively study how often patients with and~     without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked~     breaths. The investigators seek to describe the quantity of stacked breaths by continuously~     recording flow, volume, and pressure waveforms routinely displayed on the vent. The~     investigators also seek to describe how primary ICU teams manage asynchrony documenting~     interventions of sedation or vent manipulation and what modality is most successful.~   "
115715|NCT01541501|"~     Study wants to compare central corneal thickness (CCT) obtained through 3 different~     no-contact instruments and to compare them with contact ultrasound pachymetry, actually the~     gold standard technique.~   "
115716|NCT01541488|"~     Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral~     doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)~   "
115781|NCT01540643|"~     The purpose of this registry is to obtain case reports of physician experience with the~     Spiral-Z® graft under routine clinical care.~   "
115718|NCT01541462|"~     Patients requiring the use of artificial ventilation (also called mechanical ventilation)~     for more than 21 days account for more than 37% of all ICU costs. As such, these patients~     are now transferred to centers that specialize in weaning patients from the respirator;~     these units are referred to as long-term acute care (LTAC) facilities. Despite the increase~     of LTAC facilities, research on the fastest method for disconnecting the patient from the~     respirator is lacking. In addition, little information is available regarding the long-term~     survival and quality of life after a prolonged course of artificial ventilation. The purpose~     of this study is to determine the fastest method for disconnecting the patient from the~     respirator at a LTAC facility and its effect on long-term survival and quality of life.~   "
115719|NCT01541449|"~     The investigators think that there is a connection between the use of plaquenil and the~     prevention of Age related macular degeneration (AMD). The investigators believe that the use~     of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization~     (CNV) growth.~   "
115720|NCT01541436|"~     This research is being done because pain is a significant problem for patients with a~     variety of medical problems and following surgery or traumatic injury. Currently available~     pain medications may not relieve all types of pain or may relieve pain only at doses that~     produce side effects and potential complications.~      Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several~     unanswered questions about how it works. This research trial will help determine how RIPC~     may activate the bodies natural pain control system. The goals of this study are to see if~     RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV-~     B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to~     skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the~     active ingredient in hot chili peppers) on skin.~      Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood~     pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then~     deflated and blood flow resumes. The process is repeated up to three times. This procedure~     causes the body to increase its natural pain relief system that may help to decrease the~     amount of postsurgical pain.~   "
115721|NCT01541423|"~     This observational (non-interventional) study is being conducted to characterize the safety~     and use of CINRYZE in routine clinical practice when administered for (1) routine prevention~     of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3)~     treatment of angioedema attacks.~   "
115722|NCT01541410|"~     The purpose of this feasibility study is to investigate the clinical performance of the~     Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the~     thoracic aorta.~   "
115723|NCT01541397|"~     Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy~     to those not on therapy. The investigators hypothesize that after one year of KUVAN™~     therapy, there will be an improvement in their bone mineral density.~   "
115724|NCT01541384|"~     Novel wireless technology has created inexpensive tools that allow both accurate monitoring~     of adherence to pills as well as real-time interventions such as automated reminders in the~     event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an~     electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle~     opening and a valid approach to verifying self-administered pill taking, reflecting not only~     daily use but also patterns of drug use and timing. At the prescribed times, bottle will~     electronically transmit whether a subject opened the pill cap to take the immunosuppressant~     medication via a built-in transmitter to the central server. The investigators will~     randomize participants to usual care, customized reminders, and customized reminders paired~     with provider notification in the event of low adherence.~      The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney~     transplant recipients.~      The investigators' hypotheses: a) Automated reminders will improve adherence to~     immunosuppression compared to usual care, and b) Automated reminders, paired with provider~     notification about patients with poor adherence, will improve adherence to immunosuppression~     compared to usual care.~   "
115725|NCT01541371|"~     The purpose of this study is to evaluate the effectiveness of paliperidone extended-release~     (ER; designed to slowly release a drug in the body over an extended period of time) tablets~     in participants with schizophrenia (psychiatric disorder with symptoms of emotional~     instability, detachment from reality, often with delusions [a false belief held in the face~     of strong differing evidence, especially as a symptom of psychiatric disorder] and~     hallucinations [imagining things], and withdrawal into the self) who were not satisfied with~     other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute~     psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine,~     quetiapine and risperidone) they had been taking. The safety and tolerability of~     paliperidone ER tablets will also be assessed.~   "
115726|NCT01541358|"~     This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography~     (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic~     procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone~     cancer~   "
115727|NCT01541345|"~     Since there are no clinical studies available comparing the gold standard (autogenous bone~     graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded~     with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the~     present exploratory study has been designed.~      The aim of the present study is therefore to test whether or not the application of a~     xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and~     histologically similar outcomes as the gold standard (autogenous bone block) for the~     regeneration of chronic ridge defects.~      The investigators expect that there is no difference in bone quantity and quality between~     the two methods and that the use of the test treatment will be more user and patient~     friendly according to the patient perception/acceptance since no second surgical site will~     be necessary as well as cause less complications.~   "
115818|NCT01540162|"~     EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in~     Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers~     including those on tube feeding tube, diarrhea in children, prophylactics of pathological~     colonization in newborns including premature newborns, and improvement of immunity in~     newborns (mature and premature).~      The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for~     immunity improvement in preterm newborn infants~   "
115728|NCT01541332|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness~     (good and bad effects) of a combination of three different drugs, pomalidomide, pegylated~     liposomal doxorubicin, and dexamethasone when used to treat relapsed (the disease came back)~     or refractory (the disease did not respond to past treatment) multiple myeloma. Different~     dosages (amount of study drug) of pomalidomide are first being tested to determine if there~     are any side effects or risks associated with combining this study drug with the other two~     listed. Once the optimal dose is decided on, the study will change its focus to determining~     the effectiveness of the study drug in this combination.~   "
115729|NCT01541319|"~     A large multicenter randomized controlled trial of approximately 1700 critically ill~     patients' status post complex cardiac surgery with sternotomy, called the Red Cell Storage~     Duration Study (RECESS), is currently ongoing. In the RECESS trial, study groups are~     randomized to either RBCs of less than or equal to 10 days storage time or to greater than~     or equal to 21 days. The primary outcome of RECESS is a change in multiple organ dysfunction~     score. Secondary outcomes in RECESS include all cause 28-day mortality, mechanical~     ventilation free days, and other clinical outcomes. The RECESS study presents a unique~     opportunity to investigate mechanisms associated with RBC storage duration in the context of~     clinical outcomes for well-characterized surgical study groups. The ancillary study~     described here is called the Mechanism and Repository Study (MARS) for RECESS.~      The MARS study will analyze the most commonly reported and hypothesized mechanisms~     considered to be associated with the RBC storage lesion and adverse outcomes in critically~     ill patients. Laboratories with expertise in RBC function, nitric oxide mechanisms, the~     coagulation cascade, microparticle analysis and immunology will each examine hypotheses~     addressing mechanisms potentially able to relate storage time to clinical outcomes in RBC~     transfusion recipients. At the conclusion of the study, the results will provide a much~     better understanding of how RBC storage age affects recipient RBC function, coagulation~     parameters, microparticle load and immune modulation. Perhaps most importantly, this study~     will also develop a large sample repository for future analysis.~   "
115730|NCT01541306|"~     Achondroplasia and hypochondroplasia are the most common forms of dwarfism. Recent studies~     have shown that a small hormone called C-type natriuretic peptide (CNP) is an important~     regulator of linear growth. The investigators believe that genetic abnormality that causes~     achondroplasia and hypochondroplasia also disrupts CNP signaling, which may contribute to~     the growth problem. The investigators propose to look at levels of this and other closely~     related hormones in children and adults with achondroplasia or hypochondroplasia to see if~     they are different from levels in healthy people. The investigators hypothesis is that CNP~     levels are elevated in children with achondroplasia or hypochondroplasia, compared the~     healthy population. Another hypothesis is that CNP levels are not elevated in adults with~     achondroplasia or hypochondroplasia, since adults have no growth-plate cartilage. By~     studying the potential role of the CNP system in achondroplasia and hypochondroplasia, not~     only will the investigators provide further insight into the pathophysiology of these common~     syndromes, the investigators will also provide greater insight into the regulation of normal~     linear growth.~   "
115731|NCT01541293|"~     This is a study to investigate whether instilling a small amount of liquid lidocaine into~     the uterus will decrease pain felt by women during laminaria insertions done for cervical~     dilation prior to second trimester abortion.~      The investigators hypothesize that women who receive intrauterine lidocaine in addition to a~     paracervical block will experience less pain than women who receive only a paracervical~     block.~   "
115732|NCT01541280|"~     Patients included in the study with high risk acute myeloid leukemia or myelodysplastic~     syndrome as defined will receive an allogeneic transplantation conditioned by either~     myeloablative or reduced regimen. Following allogeneic transplantation, patients will~     receive a maintenance regimen combining chemotherapy with azacitidine (aza) and~     immunotherapy with donor lymphocyte infusion.~   "
115733|NCT01541267|"~     The main purpose of the study is to compare the effects of three different types of RAAS~     blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.~   "
115734|NCT01541254|"~     The purpose of this study is to evaluate the safety and probable benefit of the Low-profile~     Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when~     used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with~     bare platinum embolization coils.~   "
115735|NCT01541241|"~     THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients~     with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery~     resistance index and pulsatility index) to prove the relationship between these changes and~     bleeding in these patient .~   "
115736|NCT01541228|"~     Aim of the study: To evaluate clinical effectiveness of two different light doses when~     treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.~   "
115737|NCT01541215|"~     This trial is conducted globally. The aim of this trial is to assess the efficacy and safety~     of liraglutide in the paediatric population in order to potentially address the unmet need~     for treatment of children and adolescents with type 2 diabetes.~   "
115738|NCT01541202|"~     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of~     heart failure.~   "
115739|NCT01541189|"~     To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.~   "
115740|NCT01541176|"~     The main objective of this study is to demonstrate that the absence of post-transplantation~     corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical~     reading) on biopsy at one year post-transplantation than immunosuppressive treatment~     strategy that includes standard oral corticosteroids.The secondary objectives of the study~     consist to compare on various parameters (fibrosis progression, renal function, dialysis,~     ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival,~     clinical and biological tolerance) therapy with no corticosteroids post-transplantation in~     comparison to standard immunosuppressive treatment strategies including oral~     corticosteroids. Secondary objectives of the study consist also to compare the two~     techniques for assessing fibrosis by numerical reading and by centralized blinded reading of~     the treatment group (by 2 anatomical pathologists).~   "
115819|NCT01540149|"~     The purpose of the registry is to assess workload of a Home Monitoring based follow up for~     Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization~     therapy defibrillators (CRTD) patients.~   "
115741|NCT01541163|"~     Although cardio-embolic etiology of ischemic stroke (IS) is largely respected, there is~     still no clear recommendation for routine complex cardiological examination in all IS~     patients. Using complex cardiological examination the investigators expect:~        1. more accurate detection of patients with concomitant heart disease (cardiac rhythm~          disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial~          and ventricle septum defects)~        2. higher number of etiologically determinated IS, which is crucial for accurate secondary~          prevention.~   "
115742|NCT01541150|"~     Pedophilic behaviors represent a public health problem with serious consequences. The~     investigators hypothesize a disruption in the decision-making strategies among sex offenders~     pedophiles. Highlight this type of abnormality would offer a specific treatment of a~     possible neuropsychological deficit (with cognitive remediation for instance) and perhaps~     avoid recurrences of this type of behavior.~   "
115743|NCT01541137|"~     The investigators investigated whether a strictly controlled pain management with patients~     participating in a clinical study can attenuate persistence of post-thoracotomy pain. The~     investigators also wanted to find out whether NSAID + intravenous patient-controlled~     analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.~   "
115744|NCT01541124|"~     Background and Objectives:~      The drugs used as recommended by the WHO does not promote pain relief for all patients with~     cancer pain. The objective of this study was to evaluate the use of morphine as the first~     drug for the treatment of moderate cancer pain by visual analogue scale in patients with~     advanced disease and / or metastases, as an alternative to the recommendations of the WHO~     analgesic ladder advocated. Methods: The patients without opioid therapy with more than 18~     years, were randomly divided into two groups. G1 patients received medication according to~     the analgesic ladder, starting treatment with non-opioid in the first step, the second weak~     opioid and opioid potent in the third, and G2 received morphine as first analgesic. There~     was evaluated the efficacy and tolerability of initial use of morphine every 2 weeks for 3~     months. Results: The study was performed in 63 patients. The groups had similar~     demographics.~   "
115745|NCT01541111|"~     This study is an evaluation of the analgesic effect of magnesium associated with morphine in~     patients with cancer pain.~   "
115746|NCT01541098|"~     This is a multi center, phase 2 randomized controlled study to determine the effect of~     lyophilized plasma in patients on warfarin therapy.~   "
115747|NCT01541085|"~     The purpose of this study is to study the kinetics (study of the rate of change) of immune~     recovery quality and function in stored plasma blood samples of treatment-naive (not~     previously treated with antiretroviral drugs) patients with advanced human immunodeficiency~     virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active~     antiretroviral therapy (HAART) regimen.~   "
115748|NCT01541072|"~     The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution~     after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell~     malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral~     stem cell transplantation.~   "
115749|NCT01541059|"~     The main objective of this study is to demonstrate the superiority of local analgesia with~     ropivacaine versus placebo on postoperative pain during the first 24 hours following~     bilateral surgery of all four third molars under general anesthesia.~   "
115750|NCT01541046|"~     Infantile colic is a common medical condition which remains a frustrating problem for~     parents and health care providers with no clear treatment guidelines. To fill the void in~     existing literature, we present a protocol to examine whether probiotics are effective in~     decreasing infantile colic symptoms when compared to placebo treatment.~      We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce~     symptoms of infantile colic in breastfed infants in comparison to placebo.~      An interim analysis will be conducted after 50 infants randomized to monitor both safety and~     efficacy.~   "
115751|NCT01541033|"~     The purpose of this study is to identify biomarkers in this subset of autism patients,~     design a protein based assay system for screening serum for these biomarkers and confirm~     that these serum antibodies are still present at one year's time.~   "
115752|NCT01541020|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance. Deficits in proprioception are found in a subgroup of~     patients with low back pain. In addition, disorders of respiration have been identified as~     strongly related to low back pain.~      The aim of the study is to clarify whether loading of the inspiratory muscles has a negative~     effect upon proprioceptive postural control in healthy individuals and individuals with~     recurrent low back pain.~   "
115753|NCT01541007|"~     Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in~     men with metastatic castration resistant prostate cancer. This was demonstrated in the~     Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost~     one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose~     delays or stopped treatment due to toxicity. ConCab examines another scheduling for~     cabazitaxel to see if we can improve tolerability so that patients will receive a higher~     percentage of the treatment as planned.~   "
115754|NCT01540994|"~     The purpose of this study is to evaluate a short course (five radiation treatments) of very~     focused (stereotactic) external beam radiation therapy for the treatment of early stage~     prostate cancer.~   "
115755|NCT01540981|"~     The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction~     with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury~     (DTI) progression to advanced stage pressure ulcers.~   "
115756|NCT01540968|"~     The purpose of this study is to investigate the effect of a combined treatment of~     nutritional therapy and physical exercise in palliative cancer out-patients. The~     investigators hypothesize that this combined intervention consisting of an increased energy-~     and protein intake and physical exercise level improves quality of life (QoL), functional~     and clinical status.~   "
115820|NCT01540136|"~     This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with~     IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal~     carcinoma.~   "
115757|NCT01540955|"~     There are over 2 million breast cancer survivors in the US today. Along with extended~     survival, many women experience short and long-term after effects of treatment, which may~     decrease their quality of life and contribute to other health problems. Cognitive~     complaints---difficulties with memory, concentration, and planning—are commonly reported~     after adjuvant treatments for breast cancer. This study is designed to test the efficacy of~     a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints~     and test performance, in comparison to women who will receive the same intervention at a~     later time (wait-list control). Women will also have an EEG test performed before and after~     the intervention program to see if improvements in cognitive complaints and performance can~     be documented by examining the EEG.~   "
115758|NCT01540942|"~     The study was aimed to determine whether perioperative nutrition treat and(or)the~     perioperative disease activity were associated with postoperative recurrence and~     complications after bowel resection for Crohn's disease.~   "
115759|NCT01540929|"~     This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form~     600s (SF600s) generated during screening of service members for possible immunization with~     the ACAM2000® smallpox vaccine.~      Primary Objective:~        -  To evaluate the accuracy of the DoD smallpox vaccination screening process in military~          personnel.~      Secondary Objective:~        -  To describe the number of subjects who are excluded from vaccination, stratified by the~          pre-defined categories for exclusion (separately for the Screened and Evaluable~          Populations).~   "
115760|NCT01540916|"~     Alterations of acid-base equilibrium are very common in critically ill patients. Thus,~     understanding their pathophysiology and the possible compensatory mechanisms acting in~     different organs may play an important role in better set the consequent clinical treatment.~     The lung and the kidney are the two principal actors of such regulations. Although the~     respiratory response to acid-base alterations is well understood, less information are~     available for what the renal system is concerned. Such lack of information is partially due~     to: 1) the historical consideration of the kidney as a slow organ, in response to~     variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess~     renal response.~      Our group has recently developed a monitoring system aimed at analyzing, in a~     quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of~     urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).~      The investigators hypothesize that the renal system reacts to large as well as to minimal~     variations of the acid-base equilibrium (especially induced by a variation in the~     respiratory function) in a very fast way, modifying the urinary concentration (and therefore~     the urinary excretion) of ammonium and some electrolytes (especially chloride).~   "
115761|NCT01540903|"~     The proposed trial will evaluate whether relatively non immune populations in endemic~     countries can be effectively infected with aseptic, purified, cryopreserved sporozoites~     (PfSPZ Challenge) given intradermally.~   "
115762|NCT01540890|"~     Main of the study is to assess the influence of high-dose opioids on the sleep architecture~     and patterns of breathing using non-invasive polysomnographic measurements before and after~     opioid withdrawal in patient who undergo opioid withdrawal independently from the present~     study. These data will be compared to polysomnographic data of patients under opioid~     treatment who do not undergo opioid withdrawal as well as to patients without opioid~     treatment.~   "
115763|NCT01540877|"~     Main of the present study was to develop a model of concomitant C-fibre block and~     sensitization eliciting spontaneous pain as well applying topical capsaicin and local~     anesthetics (LA) to examine the sensory alterations after combined C-fiber block and~     sensitization in both different application orders (sensitization of blocked C-fibers and~     block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect~     stronger sensory changes during the combined substance application than during the~     monoapplication. We expect also contralateral sensory alterations mirroring the changes on~     the intervention site after the combined capsaicin and LA application, being stronger than~     after sensitization alone absent after C-fiber block alone.~   "
115764|NCT01540864|"~     The purpose of this study is to compare the safety and effect of HPP404 versus placebo on~     body weight in overweight or obese subjects.~   "
115765|NCT01540851|"~     The objectives of this research are to:~      Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing~     primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will~     compare a Care Navigator post-discharge intervention versus Usual Care post discharge~     management of patients undergoing TKA. The intervention will focus on the challenging~     process of transitions from the acute care hospital to inpatient or outpatient~     rehabilitation, and from inpatient rehabilitation to home.~      The principal goals of the trial are:~        1. To establish whether Care Navigator intervention improves functional outcomes as~          compared with the Usual Care treatment six months after TKA surgery.~        2. To establish whether Care Navigator intervention is cost effective six months after~          TKA surgery.~      The investigators hypothesize that:~        1. Incorporating the Care Navigator role into the Usual Care treatment will increase TKA~          patients' rate of adherence to the rehabilitation protocol and improve functional~          outcomes.~        2. Addition of a Care Navigator is cost-effective.~   "
115766|NCT01540838|"~     The main purpose of this trial is to test if mortality of childhood bacterial meningitis can~     be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional~     bolus administration four times daily (qid), combined with high-dose paracetamol orally,~     when both treatments are executed for the first 4 days. The series will be collected at~     Hospital Pediátrico David Bernardino, Luanda, Angola.~      The recruitment of patients begins, the conditions permitting, in early 2012. The criteria~     for patient participation is a child at the age of 2 months to 15 years who presents with~     the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is~     performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.~   "
115767|NCT01540825|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 113608 in healthy male volunteers following oral administration of single rising doses.~      A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single~     dosing.~   "
116135|NCT01536015|"~     The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor~     symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis:~     Rotigotine will decrease OFF time compared to Placebo.~   "
115768|NCT01540812|"~     Trial protocol intended the optimization of induction treatment with:~        1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.~        2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of~          high doses of anthracyclines has not brought higher response rates or longer duration~        3. Replacing the poor cytological response at day 14 by the level of ER at the end of~          induction as a criterion to decide the further treatment (consolidation or second~          induction), so as to have only one criterion (the ER) throughout the study to decision~          making.~      For another hand, reducing non-essential drugs consolidation blocks to try to reduce~     toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to~     ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3~     to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate~     with this strategy.~      Performing an allo-HSCT early (after one cycle of consolidation) for patients with~     inadequate level of ER after two cycles of induction or in those patients who required two~     courses of induction and have obtained proper ER after the second.~      Conducting studies of RD centrally by cytofluorometry following Euroflow consensus~     standards, to avoid bias in making treatment decisions~   "
115769|NCT01540799|"~     The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine~     ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine~     headache symptoms and migraine frequency in high disability migraineurs.~   "
115770|NCT01540786|"~     This study aims to identify differences in bladder contractions during the storage phase~     (non voiding activities) between OAB subjects and healthy subjects, using high resolution~     urodynamics.~      The study is divided into two parts:~        -  PART 1: Consists of 5 females with overactive bladder~        -  PART 2: Consists of 25 females with overactive bladder and 15 healthy females~      Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects~     will be reviewed and analysed by a group of experts before starting the second part (part 2)~     of the study.~   "
115771|NCT01540773|"~     The purpose of the study is to confirm the results of a prior study that demonstrated pills~     containing two amino acids which are in foods increased growth hormone and insulin-like~     growth factor-1.~   "
115772|NCT01540760|"~     This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose~     study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy~     volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15~     and 29.~   "
115773|NCT01540747|"~     To evaluate the effects of melatonin supplementation on the main in vitro fertilization~     (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome~     (PCOS).~   "
115774|NCT01540734|"~     A single dose pharmacokinetic study investigating two paracetamol formulations~   "
115775|NCT01540721|"~     This study will evaluate the pharmacokinetic profiles of experimental formulations of~     paracetamol.~   "
115776|NCT01540708|"~     The purpose of this study is to optimise the device and/or formulation of the Fluticasone~     propionate (FP)/salmeterol (SALM) unit dose powder inhaler (Rotahaler) to achieve drug~     delivery characteristics comparable to the Fluticasone propionate /salmeterol DISKUS~     inhaler. The indication is asthma and chronic obstructive pulmonary disease. The study is an~     open-label, randomised, cross-over, single centre study in healthy volunteers and will be~     conducted in a maximum of 3 parts, A, B and C. The design is adaptive and pharmacokinetic~     (PK) data analysis follows each part to enable a decision on whether progression to the~     subsequent parts is required.~      Part A of the study will test an alternative version of the Rotahaler with a low airflow~     resistance. The study will then test one or more of the following options depending on the~     outcome of part A. If progressed, part B will test modified Rotacap formulations including:~     (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule~     types. Part B will also test other versions of the Rotahaler with intermediate airflow~     resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a~     new unit dose DPI device (BUDI).~      A total of 36 subjects will be enrolled in each part to ensure 32 complete. In each~     cross-over arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling~     following administration of the 7th dose. A three-day minimum wash-out period will separate~     each cross-over arm.~   "
115777|NCT01540695|"~     This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims~     to determine whether:~        1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE)~          H&E sections alters the histology in skin tumor specimens.~        2. Which specific histologic parameters are altered between previously cryofixed versus~          routine FFPE sections. Histologic observations will be recorded by two~          dermatopathologists and two Mohs surgeons and statistically analyzed.~   "
115778|NCT01540682|"~     This study will evaluate the initial safety and effectiveness of an investigational drug,~     MLN8237, added to routine radiation therapy and cetuximab in patients with head and neck~     cancer. This study will also determine the highest dose of MLN8237 that can be given~     together with cetuximab and radiation therapy without causing severe side effects.~   "
115779|NCT01540669|"~     The aim of the study is to test the effect of polydextrose on whole gut transit time and~     gastrointestinal symptoms in a dose-responsive manner.~   "
115780|NCT01540656|"~     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in~     pressure was observed in the external urethral sphincter along with an increase in bladder~     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve~     Stimulation (TMNS) in women could induce pressure increment of the external urethral~     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33~     women suffering from urinary stress incontinence were able to contract their pelvic floor~     muscles and had become free of symptoms. Another pilot study has shown promising effect on~     the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after~     a radical prostatectomy have shown promising results. A randomized investigation of TMNS~     applied in the immediate period after a radical prostatectomy to investigate effects on both~     continence and erectile function is on going.~      The present study aims to treat urinary incontinence in men who are still incontinent more~     than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of~     6 weeks and the results of the treatment is then evaluated. The participants will be~     randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts~     after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at~     12 weeks.~      The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks~     with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis~     of questionnaires, micturition diaries and diaper tests.~      If the investigators are able to demonstrate a significant reduction in the incontinence~     symptoms in the subjects the investigators asses that vibration can be a way of~     reestablishing normal continence in men after a radical prostatectomy.~   "
115782|NCT01540630|"~     This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in~     patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an~     initial open-label phase.~      Patients will participate in an initial open-label treatment period of 21 days of CNV1014802~     150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg~     tid or placebo.~      Following an interim analysis after 10 evaluable patients have completed the open-label~     phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the~     trial if the responder rate is less than 60%.~   "
115783|NCT01540617|"~     Low back pain (LBP) is a well known health problem in Western society that is significantly~     responsible for socio-economic problems like absenteeism and disability. The lifetime~     prevalence of LBP is 60-80% and approximately 85% of this LBP has a non-specific character~     whereby the underlying causes and risk factors cannot be demonstrated. While many people~     recover within a month, most individuals will have recurrence within a year with more severe~     symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired~     proprioception, the ability to discern body/limb positions and movements, may cause and~     maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP~     rely more on proprioceptive signals from the ankles due to less reliable proprioceptive~     input of proximal segments. Moreover, they show a decreased variability in postural control~     and less postural robustness, while variability is a prerequisite for optimal functioning of~     biological systems. However, further clarification of the neural correlates is necessary.~     Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with~     a decreased ability of the brain to process proprioceptive inputs.~      The aim of this project is to clarify the central changes in individuals with recurrent~     non-specific low back pain and healthy controls. To evaluate these central changes MRI~     techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between~     central changes and postural control tasks will be evaluated.~   "
115784|NCT01540604|"~     This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy~     (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.~   "
115785|NCT01540591|"~     Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm~     injection ( ICSI) failure due to elevated TH1 cytokine response.~   "
115786|NCT01540578|"~     This clinical trial is studying biomarkers as a diagnostic tool in samples from younger~     patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help~     improve the treatment of patients with B-cell acute lymphoblastic leukemia~   "
115787|NCT01540565|"~     This phase II trial studies how well veliparib works in treating patients with epithelial~     ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond~     to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
115788|NCT01540552|"~     RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung~     cancer may help doctors learn more about the disease and find better methods of treatment.~      PURPOSE: This trial studies the natural history of lung nodules using CT scans from~     participants at high-risk for lung cancer.~   "
115789|NCT01540539|"~     The purpose of this study is to study the safety and tolerability of intravenous (IV) and~     subcutaneous (SC) administration of REGN1154 in normal healthy subjects.~   "
115790|NCT01540526|"~     The main purpose of this study is to learn more about the safety of an investigational drug,~     axitinib. An investigational drug is a drug that has not been approved by the Food and Drug~     Administration (FDA) and is available for research use only. Researchers will also see what~     changes happen to the tumors while taking the axitinib and after it is stopped (during the~     scheduled breaks), and what changes in the tumor may be responsible for this growth. This~     will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is~     considered an investigational type of scan and is not used for clinical care. These scans~     are not approved by the FDA, their use in this study is just for research purposes.~      In addition, the investigators want to find out how the drug is processed and distributed in~     the human body. The investigators will also look at how different types of cancer are~     affected by axitinib.~   "
115791|NCT01540513|"~     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404~     PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and~     determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating~     tumor dosimetry. The long-term goals of this research are to improve the diagnosis and~     treatment of malignant brain tumors by using radioiodinated NM404~   "
115792|NCT01540500|"~     The purpose of this research study is to evaluate whether administration of a CYP1A2~     inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The~     safety and tolerability of tasimelteon will also be assessed throughout the study.~   "
115793|NCT01540487|"~     The aim of the trial is to assess the relative bioavailability of fixed dose combination~     tablets of linagliptin and metformin compared to the administration of two single tablets~     (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose~     combination tablet is expected to significantly enhance patients` compliance with~     antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic~     patients.~   "
115809|NCT01540279|"~     Background: Poor wound healing and the development of surgical site infection (SSI) continue~     to occur and remain a significant cause of disability among operated patients. In spite of~     the substantial advances in our understanding of the epidemiology, pathogenesis and~     prevention it remains one of the most common complications in conventional abdominal surgery~     with an incidence in the literature between 4% and 17%. As it is known that surgical sutures~     potentiate the development of wound infection the search for an ideal suture material,~     suitable for all purposes has been pursued by surgeons for decades.~      Hypothesis: In line with in-vitro results the investigators hypothesize that the use of~     antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after~     open abdominal surgery Methods: To prevent microbial colonization of suture material in~     operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture~     materials with antibacterial activity will be tested against un-coated suture material for~     skin closure after open abdominal surgery of 200 patients. The study is planed as a single~     center, randomized controlled trial. After ethical approval the patients will be~     consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University~     Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to~     detect and document wound complications. Wound complications will be classified according to~     Center for Disease Control and Prevention Standard guidelines. Data will be collected and~     the rate of SSI will be analysed in both groups.~      Expected value of the proposed project: If the investigators can confirm the proposed~     hypothesis in our study this could be a promising and feasible approach to lower SSI after~     open abdominal surgery and might be also used in other surgical fields. By lowering the rate~     of SSI the investigators might offer a new and cost saving procedure to the surgical~     community.~   "
115794|NCT01540474|"~     Malaria has remained a major concern for the US military. During World War II, malaria was~     the leading cause of disease and non-battle injury with 500-700 men infected per day,~     resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for~     protecting troops against malaria are insecticidal nets, clothing, and antimalarial~     treatment. To be effective, these methods must be self-administered and be used~     consistently, often unattainable in field or combat situations. The United States Army~     Medical Research and Development Command (USAMRMC), through the United States Army Medical~     Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research~     (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum~     malaria; development of such a vaccine is a high priority for the US military and other~     individuals who travel to endemic regions, and is equally important to populations residing~     in those areas.~      A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS)~     vaccine will~        1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine~          FMP012/GLA-SE~           Secondary:~        2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent~          assay (ELISA)~        3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite~          challenge.~   "
115795|NCT01540461|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).~   "
115796|NCT01540448|"~     The aim of this study is to evaluate if the prior knowledge of the individual mesenteric~     vascular anatomy of patients represents an advantage in performing laparoscopic colorectal~     resections. The investigators want demonstrate that the three-dimensional reconstruction of~     colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and~     less extensive dissection and to a fewer intraoperative and postoperative complications.~   "
115797|NCT01540435|"~     This randomized, controlled, multicenter, non-comparative phase II trial compares an~     intensified perioperative treatment of patients with resectable synchronous or metachronous~     colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.~   "
115798|NCT01540422|"~     The purpose of this study is to demonstrate improved vein graft patency rates at 12 months~     for endoscopically harvested saphenous vein grafts. The study will evaluate use~     modifications to existing techniques in vein graft handling during harvests. A secondary aim~     is to develop a standardized approach for harvesting, handling, and preparing vein grafts in~     the endoscopic approach.~   "
115799|NCT01540409|"~     The primary objective of this study is to assess the ongoing efficacy, safety, and~     tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne~     muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen~     study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers~     for DMD and the clinical status of participating DMD subjects.~   "
115800|NCT01540396|"~     This is a pilot feasibility study of 40 pregnant women to test the investigators'~     recruitment, enrollment and randomization procedures in preparation to conduct a larger~     randomized control trial to compare diagnostic methods for gestational diabetes. The two~     methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1~     hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and~     Coustan criteria).~   "
115801|NCT01540383|"~     The purpose of this study is to examine whether 3 weeks of intensive language therapy~     provided in clinical in- and outpatient settings is effective in improving everyday~     communication in postacute/chronic post-stroke aphasia, as measured by performance on the~     Amsterdam Nijmegen Everyday Language Test (ANELT).~   "
115802|NCT01540370|"~     This study will evaluate assessments from the Goniometric Lens compared with those from~     anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular~     hypertension (OHT).~   "
115803|NCT01540357|"~     In the present randomized waiting-list-controlled study the investigators examined a~     specific manualized mindfulness-based therapeutic approach in the treatment of chronic~     tinnitus.~   "
115804|NCT01540344|"~     The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS)~     of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS)~     and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with~     peritoneal carcinomatosis arising from colorectal cancer.~   "
115805|NCT01540331|"~     The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term~     of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.~   "
115806|NCT01540318|"~     The major goal of this project is to conduct a randomized controlled trial studying an~     initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal~     ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's~     objectives are to compare the following variables in those that randomize to abdominal~     ultrasound versus those that do not:~        1. rate of abdominal CT scanning~        2. time to emergency department disposition~        3. the rate of missed/delayed diagnosis of intra-abdominal injury~        4. the costs.~   "
115807|NCT01540305|"~     This study aimed at verifying whether sessions of repetitive transcranial magnetic~     stimulation over a certain brain area (the supplementary motor area) could be useful in the~     relief of Obsessive-Compulsive Disorder symptoms.~   "
115808|NCT01540292|"~     This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in~     Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with~     active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) > 220~     despite conventional treatment will be included over 4 years in this phase I-II trial. This~     will be a pilot open label trial. Patients will be treated with 2 successive injections of~     allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8~     and 12.~   "
115810|NCT01540266|"~     Assessing whether structuring of discharge information improves the sender's recall capacity~   "
115865|NCT01539525|"~     The investigators propose to use obstetric-gynecological clinics to conduct a randomized~     clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and~     Treatment), delivered either by a trained nurse or by computer, to usual care (a control~     condition). As part of this trial, the investigators will include outcomes that allow us to~     assess the cost effectiveness of these three conditions.~   "
115811|NCT01540253|"~     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when~     given together with docetaxel in treating patients with advanced solid tumor that is locally~     advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120~     together with docetaxel may kill more tumor cells.~   "
115812|NCT01540240|"~     The primary objective of the study is to compare the tolerance and safety between a low-dose~     Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV~     patients initiating a first line antiretroviral therapy. The investigators expect that the~     low-dose regimen will show improved tolerability and safety compared to the standard dosage,~     with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or~     increasing their anaemia grade during the first 6 months of treatment.~      The secondary objectives of the study is to compare the efficacy of the two dosing regimen,~     as measured by classical clinical and biological markers: the number of new AIDS defining~     illness, the mortality rate, the proportion of patients achieving virological success and~     the mean CD4 cell count increase from baseline.~   "
115813|NCT01540227|"~     Syphilis is a sexually transmitted infection that causes genital sores and rash, but in some~     circumstances may result in more severe and unexpected symptoms. These severe symptoms could~     include eye infections, meningitis (infection of the membranes covering the brain and spinal~     cord), and liver infection. If not properly treated, syphilis can also lead to heart~     problems and dementia (a decline in reasoning, memory and other mental abilities) years down~     the road. There has been an increase in the number of reported cases of syphilis in North~     America, Europe, and Australia over the past decade. The number of new syphilis infections~     in Canada has increased roughly 10-fold over the past 10 years.~      Since 1943, the antibiotic penicillin has been used to treat syphilis; however, very little~     information has been gathered to determine the proper dose of penicillin or appropriate~     duration of treatment. Added to this, several studies have shown that the recommended dose~     of penicillin fails to cure syphilis in 20-30% of patients. Since the number of people~     infected with syphilis is increasing, and since syphilis has the potential to cause serious~     disease, the investigators need better information on how to treat syphilis effectively.~      This study aims to determine whether the current dose of penicillin recommended to treat~     syphilis is sufficient to cure the infection. Specifically the investigators will try to~     determine whether the amount of penicillin in your blood 3 and 7 days after receiving~     treatment for syphilis is sufficient to cure the infection as demonstrated by a blood test 6~     or 12 months from now. This study is a multi-centered trial based in Ottawa but with centers~     recruiting both in Montreal and Toronto. A total of 120 participants with syphilis will be~     recruited into this study. The treatment you will receive for syphilis in this study does~     not differ from that you would receive normally; the investigators are only observing the~     levels of penicillin in your blood and relating them with the outcome of treatment.~   "
115814|NCT01540214|"~     Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are~     present in approximately 50% of patients with POP. For many women the accompanying symptoms~     of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse~     may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with~     dissatisfaction with the final results of an operation for POP.~      The primary aim of this research project is to investigate the difference in prevalence~     (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair~     surgery. The secondary objectives are to determine changes in bladder function at 6 and 12~     months after surgery and to identify predictive factors for persistence, disappearance or de~     novo symptoms of OAB after POP surgery.~      Women who present with POP and who will undergo surgical treatment will be evaluated at~     baseline before their surgery and will be followed for the duration of one year after~     surgery.~   "
115815|NCT01540201|"~     Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung~     ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs~     the inspiratory time greater than expiratory time, can be applied for adult respiratory~     distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean~     airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV~     with lung protective strategy.~   "
115816|NCT01540188|"~     Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection~     is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily~     contact with their family or live in their parent's home. The burden on their families is~     substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct~     an intervention pilot to develop and evaluate a family intervention to improve outcomes over~     time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a~     province located about 80 km from Hanoi, Vietnam's capital.~      Two teams with complementary expertise collaborate to implement this study: the UCLA team~     and the Vietnamese team from the Vietnam National Institute of Hygiene & Epidemiology~     (NIHE). The study has two phases:~        -  In Phase 1, the investigators develop the content, format and an implementation plan~          for the intervention from a focus group of 10 service providers, administrators and~          community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-)~          recruited from the local drug rehabilitation center (the 06 Center) and from two~          local communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the~          IDUs family members (FM). Based on the findings, the investigators collaborate on~          designing a Vietnamese-specific family intervention for IDUs and their family members.~        -  In Phase 2, the investigators pilot the intervention in the local commune health~          centers in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members~          are recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a~          intervention group and a control group. After the 4-week intervention, 3-month and~          6-month follow-ups are conducted to assess the effectiveness of the intervention.~          Participants randomized to the control group only complete the assessments (baseline,~          3-, and 6-month) at the same time points.~   "
115817|NCT01540175|"~     Autologous stem cell rescue is an established therapy in high risk neuroblastoma and~     relapsed Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors~     to facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is~     usually tolerated with acceptable toxicity and graft failure is practically not existent.~     But whereas immune reconstitution in allogeneic hematopoietic stem cell transplantation~     (HSCT) setting is widely studied, the investigators have no comprehensive data available in~     the autologous setting regarding recovery of the innate and adaptive immune system. However,~     observations in patients with autoimmune disease undergoing autologous HSCT suggest not an~     exact recovery of the patient's pre-transplant immune system but some re-education during~     reconstitution of immune function.~      Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and~     immunocytokines rely on activity of the patient's own immune system via complement-mediated~     or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or~     shortly after conventional chemotherapy. To find the optimal time point for administration~     of immunotherapy, it is important to know how and when immune effector cells recover after~     conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in~     Induction regimens.~      Researchers at St. Jude Children's Research Hospital want to study the research~     participant's immune profile once prior and at multiple set time points after autologous~     stem cell infusion during the recovery process. In a subset of participants the~     investigators want to study the recovery of lymphocyte subsets and function after one course~     of conventional chemotherapy preceding the high dose chemotherapy and autologous stem cell~     transplant. That way the investigators hope to learn about the pace and order of recovery~     and the functional capacity of different compartments of the immune system during~     reconstitution.~   "
115918|NCT01538836|"~     The purpose of this study is to determine whether consuming additional protein during~     calorie restriction induced weight loss has beneficial or harmful effects on multi-organ~     (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut~     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal~     women.~   "
115821|NCT01540123|"~     Berry fruits are widely recognised as natural functional food products. They contain several~     different phytochemicals which have potential to modulate human health and wellbeing. There~     is however some debate regarding the mechanisms driving their health promoting properties.~      Despite the wide health promoting properties of fruit extracts reported in the literature,~     considerable interest over the past decade has primarily been focused on their roles in~     reducing risk factors associated with cancer and heart disease. Consequently, there remains~     a paucity of actual scientific information on their role in modulating brain functions, such~     as mood, learning and memory, any decrements of which have very negative impacts on the~     quality of life.~      Fruit phytochemicals from other sources have been shown to mediate both peripheral and~     cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with~     berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of~     oxygen and glucose as well as the removal of waste products. The modulation of cerebral~     blood flow via supplementation of berry polyphenols could therefore be a potential way to~     positively modulate human cognitive behavior. The link between acute increases in cerebral~     blood flow and increased cognition is currently a little weak but it could give a good~     platform for long term behavioral and health benefits via increased cerebral/peripheral~     blood flow and decreased MAO-B activity.~      The aims of the study are therefore to investigate the impact of the berry extract on~     digital volume pulse, blood pressure and cerebral blood flow.~   "
115822|NCT01540110|"~     Primary~      The purpose of this study is to evaluate tumour pathological complete response rate after~     six cycles of neoadjuvant docetaxel and cyclophosphamide in an Asian population.~      Secondary~      To assess:~        1. Pharmacokinetics (PK) and pharmacogenomics (PG) of docetaxel cyclophosphamide in Asian~          patients,~        2. Safety and toxicity of docetaxel cyclophosphamide in Asian patients, and~        3. To determine efficacy of short course (3 days) filgrastim in primary and secondary~          prophylaxis against febrile neutropenia in patients receiving docetaxel and~          cyclophosphamide.~   "
115823|NCT01540084|"~     Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep~     sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause~     oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can~     reduce the dosage of propofol and may result in a lower risk of oversedation. The~     investigators prospectively compare the efficacy, recovery time, patient satisfactory, and~     side effects between cocktail and conventional sedations in patients undergoing ERCP.~   "
115824|NCT01540071|"~     This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing~     down/stopping/reversing progression of the castration resistant and taxane resistant~     prostate cancer.~   "
115825|NCT01540058|"~     This is a european randomised, phase III, multi-centric study comparing a diagnostic and~     therapeutic strategy based on molecular analysis followed by suspected primary cancer~     tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown~     primary. The purpose of this trial is to determine whether or not a strategy based on~     molecular analysis is effective in improving the progression free survival rates of patients~     with carcinoma of unknown primary (CUP).~   "
115826|NCT01540045|"~     One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the~     combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like~     dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight~     loss and malnutrition, which leads to a prognostic impact in a lower patient response to~     chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects,~     impacting treatment discontinuation and therefore, morbidity and survival of patients. The~     objective of this study is to describe the threshold of perception and recognition of basic~     tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy~     and after the second cycle, and analyze the effect in the developement of dysgeusia, as well~     as the association between these and the nutritional status and quality of life.~   "
115827|NCT01540032|"~     The purpose of this study is to determine whether a low salicylate diet will improve the~     quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).~   "
115828|NCT01540019|"~     Denutrition, lost of weight and anorexia are present in many oncologic patients at any time~     of the disease. Anorexia is the spontaneous loss of appetite and many changes in the~     metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that~     includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia~     cupana) is originally from Brazil and Venezuela and has been used culturally for headaches,~     muscle pains, depression and others. As it has shown a good response and tolerability for~     fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná~     as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond~     questionaries about quality of life.~   "
115829|NCT01540006|"~     The aim of this prospective trial is the manifestation of guidelines developed for~     outpatient cardiac rehabilitation in Austria.~      The evaluation of prospective and retrospective data is supposed to give evidence on~     morbidity and/or mortality advantages compared to patients not participating in cardiac~     rehabilitation programs.~      The database created in this context is supposed to pave the way as instrument to document~     and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in~     Austria as a key for quality management.~   "
115830|NCT01539993|"~     This study is designed for patients diagnosed with Liver cancer to collect information about~     the relationship between types of liver cancer, methods of treatment and outcomes over time.~   "
115831|NCT01539980|"~     1. Silk sericin wound dressing may reduce time for complete epithelialisation of~          split-thickness skin graft donor sites compared to Bactigras®.~        2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor~          sites compared to Bactigras® .~        3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites~          infection as compared to Bactigras®.~        4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may~          not cause significant adverse events.~   "
115919|NCT01538823|"~     The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis~     of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective,~     screening techniques.~   "
115832|NCT01539967|"~     Obesity is a worldwide health problematic whose incidence is increasing especially in~     developed countries. The surgical management of this illness consists in different~     techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient~     enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could~     include the residual gastric volume.~      The aim of the present study was to determine whether the residual gastric volume is~     involved in Laparoscopic Sleeve Gastrectomy's failure.~   "
115833|NCT01539954|"~     The goal of this project is to develop a computerized screening program for primary care~     offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents~     and assess its psychometric properties among nine- to 18-yr-old primary care patients. There~     have been few studies of alcohol screening and brief intervention conducted among~     adolescents receiving primary medical care. This project will develop and validate a new~     computerized Alcohol Screening for Children and Adolescents (cASCA) system based on the two~     age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as~     secondary risk and problem assessments. The system will yield a provider report with the~     screening results, level of risk, and recommended brief advice, counseling, or referral~     strategies. The Specific Aims of this project are to: 1)Assess the sensitivity, specificity,~     positive and negative predictive values of the 'any drinking/number of drinking days' and~     'friends' questions of the cASCA in identifying past-year use as determined by the Timeline~     Follow-Back Calendar (TLFB), and for identifying any problem use, abuse or dependence as~     determined by the AUDIT, CRAFFT and a structured psychiatric diagnostic interview~     (computerized DISC-IV, Youth Version) at baseline (criterion validity); 2)Assess the~     test-retest reliability of the cASCA in measuring drinking frequency categories and in~     classifying patients into Low, Medium and High risk categories; 3)Assess the predictive~     validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting~     drinking, binge drinking, and any problem use, abuse or dependence at 12-mos follow-up;~     4)Assess the degree to which the 'any drinking/number of drinking days' item of the cASCA~     predicts drug use risk as measured by the TLFB (any use and frequency), tobacco use as~     measured by the Hooked on Nicotine Checklist (screen for potential nicotine dependence),~     drug use disorders as measured by the Drug Abuse Screening Test for Adolescents, and the~     degree to which it predicts other mental health problems as measured by the Youth DISC~     Predictive Scales at baseline and 12-month follow-up; 5)Compare the psychometric properties~     of the cASCA across subgroups, including: age, gender, race/ethnicity, practice type,~     provider type, and patient risks (e.g., those with/without friends who drink); and explore~     the possible effects of the cASCA system on drinking at 3-, 6-, 9-, and 12-month follow-ups.~   "
115834|NCT01539941|"~     The goal of this proposal is to develop and pilot a brief protocol designed to~     systematically integrate pharmacological interventions for attention deficit hyperactivity~     disorder (ADHD) into behavioral treatment services for adolescent substance users with~     comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent~     substance use (ASU) that can significantly impede successful ASU treatment but is vastly~     under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD~     medication acceptance and compliance is particularly difficult to achieve in high-risk~     adolescent populations.~   "
115835|NCT01539928|"~     The purpose of this study is to compare conventional PET/CT scan performed 1 hour after~     injection of the radioactive tracer FDG (PET/CT[1]) with PET/CT performed after 3 hours~     (PET/CT[3]) in a group of patients with biopsy verified lung cancer or high suspicion of~     lung cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are~     potentially operable.~   "
115836|NCT01539915|"~     This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic~     patients to better understand the skin penetration of topically applied BCT194.~   "
115837|NCT01539902|"~     The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on~     remission of lupus nephritis (combined partial and complete remission) in terms of~     stabilization and improvement in renal function.~   "
115838|NCT01539889|"~     Pulmonary hypertension (PH) can be the result of various clinical conditions. It may be~     idiopathic or associated with various cardiovascular and lung disorders. Currently there is~     no test that can non-invasively detect abnormalities of the pulmonary circulation. There is~     a growing need for a non-invasive method to detect PH. There currently exists only ne agent~     approved in Canada for clinical imaging of the pulmonary circulation, 99mTc-labeled~     macroaggregates. This agent is exclusively used for the diagnosis of physical defects of the~     circulation due to pulmonary embolus. This agent is larger than small pulmonary vessels,~     limiting its sensitivity to detect small vascular defects, as well as potential infectious~     risks since albumin macroaggregates are derived from human albumin. There is need then for~     new lung tracers that could provide a greater safety profile while enabling functional as~     well as anatomical imaging of the pulmonary circulation. DFH-12 (PulmoBind) is a peptide~     derived from human adrenomedullin (hAMI-52). Hence the development of this novel AM~     derivative, PulmoBind, for molecular imaging of the pulmonary circulation. PulmoBind is~     labeled with 99mTc, the most commonly used imaging isotope in nuclear medicine.~   "
115839|NCT01539876|"~     The purpose of this study is to assess the fine needle aspiration methodology in collecting~     sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample~     receiving Taxane treatment~   "
115840|NCT01539863|"~     As low back pain is often a recurrent and sometime persistent problem, research into~     prevention is important. Chiropractors have traditionally treated patients with maintenance~     care, which means that patients are seen on a regular basis to prevent recurrences or to~     stop a persistent problem getting worse. However, it is not known if this has the expected~     effect.~      This study will test the effectiveness of the maintenance care approach. Patients with~     recurrent or persistent low back pain will be treated in accordance with two different~     models. The first model is the maintenance care model, meaning that chiropractors will see~     the patient on a regular basis, regardless symptoms. The other model means that patients~     should be treated patients only when they themselves experience symptoms bad enough to seek~     care. After one year, it will be possible to see if there has been any difference between~     the groups in terms of pain, disability, quality of life and total number of treatments over~     the study period and to investigate if there is any difference in the cost-effectiveness~     between the two treatment models.Thus, the study hypothesis is that there is no difference~     between the two models regarding the number of days with pain.~      This study will be a multi-centre trial, and as part of the study, it will be necessary to~     formalize a network of research clinics all over Sweden in which participating chiropractors~     accept to perform complex data collection. This network will then have the expertise and~     potential to perform future clinical studies together with networks in other countries,~     allowing large clinical trials across countries.~   "
115841|NCT01539850|"~     The main objective of this study is to evaluate the LGL102 implant safety in obese to~     morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight~     changes will be also evaluated.~   "
115920|NCT01538810|"~     The purpose of this study is to assemble a collection of urine and blood samples for the~     development and validation of biomarkers potentially useful in correlating or improving the~     diagnostic utility of abdominal imaging.~   "
115842|NCT01539837|"~     Parkinson's disease (PD) is a common neurodegenerative disease affecting movement. Although~     drug treatments for PD are available they only treat the symptoms of the disease, fail to~     halt neuronal loss, and are associated with long term side effects and loss of efficacy.~     There is a chronic need to develop neuroprotective therapies. Increased iron and oxidative~     stress have been heavily implicated in the neurodegenerative process in PD, hence removal of~     excess iron by iron chelation represents a potential drug target. Iron chelators are~     extensively utilised to treat peripheral iron overload disorders (e.g. thalassaemia) and~     recently the investigators have demonstrated iron chelators such as Deferiprone can enter~     the brain removing excess iron and are neuroprotective in PD animal models. Although good~     tolerability and efficacy to remove brain iron has also been shown in a pilot study with the~     iron chelators Deferiprone in young patients with Friedreich Ataxia, where iron accumulates~     in the dentate nucleus, no studies have been conducted in aged individuals affected by PD.~     Hence the aims of this study are 1) to assess whether Deferiprone is well tolerated in PD~     patients, 2) whether Deferiprone can remove the excess iron levels found in the brain area~     affected by PD, the substantia nigra, as assessed by Magnetic resonance imaging (MRI) and 3)~     whether Deferiprone has any direct effect on the clinical symptoms of PD. Three groups of 12~     (total 36) early stage drug free PD patients will be treated with 20 or 30mg/kg/d~     Deferiprone or Placebo for 6 months. Over the 6 months patients will receive serial MRI~     scans, neurological examinations not only to assess PD symptoms but also psychological~     state, plus blood test to monitor for potential side effects. Positive results from this~     pilot will help support larger clinical trials to evaluate whether Deferiprone can slow~     down/halt PD.~   "
115843|NCT01539824|"~     The purpose of this study is to investigate the safety and effects of IMM 101 in combination~     with a single targeted dose of radiation in patients with metastatic colorectal cancer in~     whom chemotherapy or other treatment has not been effective. Administration of radiation~     (using the CyberKnife) to the target tumour growth in the liver results in the release of~     tumour material. IMM-101 may help the immune system to react to the tumour material released~     from the damaged tumour, and so have a beneficial effect in slowing down the rate of growth~     of other tumour growths in the liver and other organs.~   "
115844|NCT01539811|"~     This is a pilot study to explore the effects of long-course versus short course antibiotics~     on wound healing in surgically managed diabetic foot infections. Hypothesis: Diabetic Foot~     Infections (DFIs) are best managed with an early aggressive surgical approach and short term~     antibiotic use. Post-operative prolonged antibiotic use increases costs and resource~     utilization without improving outcomes.~   "
115845|NCT01539798|"~     The investigators conducted a cross-over study to compare the response of healthy young~     volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the~     body composition, serum electrolytes, albumin, and hematological parameters.~      The investigators hypothesized that these parameters will differently adapt depending on the~     route of infusion~   "
115846|NCT01539785|"~     The purpose of this study is to determine the role of surgery followed by hyperthermic~     intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with~     platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective~     randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC~     versus surgery alone in terms of progression free interval, overall survival, morbidity and~     mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28~     questionnaires.~   "
115847|NCT01539772|"~     This is a multi-center natural history study that will be conducted at participating centers~     in the Cooperative International Neuromuscular Research Group (CINRG). Following a baseline~     evaluation, participants will have three follow-up visits over a three-year period. The~     investigators will characterize the Becker muscular dystrophy phenotype, and correlate~     specific abnormal dystrophin proteins with the range of clinical outcomes.~   "
115848|NCT01539759|"~     This is a randomized controlled trial among women who deliver by cesarean at UNC Women's~     Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After~     consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a~     postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of~     the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the~     4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that~     women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months~     later than women who plan on receiving an IUD 4-8 weeks after delivery.~   "
115849|NCT01539746|"~     The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for~     predilation of the native aortic valve is associated with a reduction of the composite~     primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction~     (LVEF ≤35%).~   "
115850|NCT01539733|"~     The investigators designed a randomised multicenter clinical trial for patients with~     advanced cancer who are admitted to the medical oncology ward or high-care hospice. On~     admission all patients with advanced cancer will be asked to participate in this study.~     Consenting patients will be submitted to delirium observation screening according to the~     DOS. Subsequently DOS screening will be performed twice weekly until discharge. Each patient~     who's score is > 3 (DOS positive) is showing significant symptoms of delirium and will be~     submitted to the revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test~     validity of the DOS scale for this particular population, each DOS positive score will be~     randomly matched with a patient with a DOS score < 3 (DOSnegative) and this patient will~     also be submitted to DRS-R-98. When diagnosis of delirium is confirmed by DRS-98, patients~     will be randomised between treatment of delirium with olanzapine or haloperidol (usual~     care). Treatment in both groups will consist of identification and management of underlying~     aetiologies of delirium if possible and adding neuroleptic medication for symptom control.~     Patients who recover from their delirium episode as well as their caregivers will be asked~     to complete the Delirium Experience Questionnaire (DEQ) to assess recall of the delirium~     experience and the degree of distress related to the delirium episode.~   "
115866|NCT01539512|"~     This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect~     of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor~     control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible~     patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive~     either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating~     primary study therapy but experience definitive CLL progression are eligible to receive~     active idelalisib therapy in the extension study, GS-US-312-0117.~   "
115867|NCT01539499|"~     The goal of this study is to help better determine the complication rates for endocrine~     surgery across the nation for both benign and malignant disease. It is our hypothesis that~     the complication rates are low overall and that malignant disease results in a higher~     complication rate than benign disease. This study will do a database review from all~     University HealthSystem Consortium (UHC).~   "
115851|NCT01539720|"~     Unintended pregnancy rates in the United States are among the highest of developed nations.~     These high rates can largely be attributed to incorrect or under contraception of women. One~     focus of decreasing unintended pregnancy and abortion rates has centered on expanding access~     to and use of long acting reversible contraceptive (LARC) methods which include intrauterine~     devices (IUDs), and subdermal implants. Emergency contraception, or post-coital~     contraception, offers significant reductions in the chance of pregnancy following an act of~     unprotected or under-protected vaginal intercourse. The most common method of emergency~     contraception used in the United States is the oral levonorgestrel regimen which reduces~     pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine~     device. The intrauterine device has the added benefit of providing extended contraceptive~     use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated~     with heavier and more crampy menses however, likely dissuading women from use. Among all IUD~     users, the levonorgestrel IUS has gained popularity over the Cu-T380, perhaps because it~     offers the potential to improve menstrual related symptoms. There is no data however on the~     efficacy of the levonorgestrel IUS as a form of emergency contraception. The purpose of this~     study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception.~     Participants will be randomized to receive either the most common method, oral emergency~     contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following~     method allocation for pregnancy. Lastly, participants will be asked to complete a telephone~     surveys at 6 and 12 months following method allocation assessing their use of a consistent~     contraceptive method, their satisfaction with their contraceptive method, any use of~     emergency contraception since their enrollment in the study, and lastly any unintended~     pregnancies experienced since enrollment in the study. If we could show that the~     levonorgestrel IUS is as effective as the most commonly prescribed method of emergency~     contraception, we would be introducing another opportunity for LARC initiation and~     subsequently impacting unintended pregnancy and abortion rates.~   "
115852|NCT01539707|"~     The purpose of this study is to evaluate blood levels of solifenacin succinate (the study~     drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If~     the bladder contracts strongly and without warning, the muscles surrounding the urethra~     (detrusor muscles) may not be able to keep urine from passing. This may happen as a~     consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.~   "
115853|NCT01539681|"~     Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular~     Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with~     sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate~     the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with~     HCC under daily-life treatment conditions.~   "
115854|NCT01539668|"~     This study evaluates the women cervical samples through molecular tests in order to:~      1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer~     Hospital to evaluate their performance;~   "
115855|NCT01539655|"~     Study in healthy volunteers to assess effect of omeprazole and ranitidine on the~     pharmacokinetics of vandetanib~   "
115856|NCT01539642|"~     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab~     PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute~     moderate to severe post-operative pain after open abdominal surgery.~   "
115857|NCT01539629|"~     This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D~     device to evaluate a new feature for future heart failure devices.~   "
115858|NCT01539616|"~     ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected~     to decrease triglyceride level and also correct dyslipidemia.~   "
115859|NCT01539603|"~     The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon~     first and then bare metal stent compared with drug-eluting stent for treatment of de novo~     lesions (DEB first).~   "
115860|NCT01539590|"~     The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function~     following myocardial infarction (heart attack).~   "
115861|NCT01539577|"~     This study is a multicenter, prospective, observational study to evaluate the long-term~     safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion~     (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior~     segment uveitis in real-world clinical practice.~   "
115862|NCT01539564|"~     The objective of the study is to evaluate the safety and effectiveness of Arestin~     (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when~     used in combination with mechanical debridement.~      The hypothesis of the study is that Arestin in combination with mechanical debridement is~     more effective in the treatment of peri-implantitis when compared to mechanical debridement~     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as~     measured at qualifying implant sites.~   "
115863|NCT01539551|"~     B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the~     ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis~     related cardiac dysfunction and volume overload in critical ill patients. It is also a~     marker associated with prognosis in patients with severe sepsis and septic shock. However,~     the clinical utility of BNP level in management of early severe sepsis and septic shock over~     the first 48 hours is not clear. Besides, Lactate represents as a maker of tissue~     hypoperfusion, which has been used as a guide therapy for sepsis patients and high serum~     lactate level is independently associated with mortality in severe sepsis. Today, in~     management of early severe sepsis and septic shock, current guideline emphasize the early~     goal-directed therapy (EGDT) with achieving the central venous pressure (CVP) level 8-12~     mmHg by fluid support first, then targeting the next goal to maintain mean airway pressure~     (MAP) at least 65 mmHg by vasopressor agent (ie, Norepinephrine) and finally keeping central~     venous oxyhemoglobin saturation (ScvO2) > 70% via optimal Hct > 30% and dobutamine usage~     within first 6 hours of emergency department admission. However, the role of BNP and lactate~     in patients with severe sepsis and septic shock with or without myocardial dysfunction under~     EGDT management are not clear.~      The investigators will conduct a prospective observational study to investigate the change~     of BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT~     management, their association of cardiac dysfunction and their role in predicting various~     clinical outcome. The investigators also want to see if BNP and lactate could be useful~     tools to guide the adjustment of optimal fluid supply and the timing of inotropic agent~     intervention.~   "
115864|NCT01539538|"~     The study is intended to show that the Sufentanil NanoTab PCA System is as effective as~     morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.~     Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat~     their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.~   "
116016|NCT01537562|"~     Today a large proportion of early abortions are medical, in accordance to the woman's~     choice. The main objective of the present study was to compare, in a randomised fashion,~     initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post~     medical abortion with regard to expulsions and safety.~   "
115868|NCT01539486|"~     The intent for this study is to do a retrospective chart review of all patients who have~     undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data~     collected will be recorded under assigned identification numbers that will have no~     association with medical record or hospital numbers. Identifying characteristics will~     include age and sex. Anonymity will be upheld. The patient/family will not be contacted~     directly. All information will be obtained from the medical chart. Demographics, location,~     preoperative PTH levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and~     the outcome based on the hospital notes will be obtained from patients' charts and will be~     transferred to a secure database. It is our hypothesis that there is a linear relationship~     between immediate preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and~     the aim of this study is to better describe this relationship.~   "
115869|NCT01539473|"~     Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered~     with tyramine~   "
115870|NCT01539460|"~     Patients with axillary osmidrosis are treated with minimally invasive procedure combined~     tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in~     reducing odor is to be determined.~   "
115871|NCT01539447|"~     In a brief summary the study would like to evaluate the effectiveness of Naproxen in~     preventing radiographically detected heterotopic ossification following hip arthroscopy for~     the treatment of femoroacetabular impingement.~   "
115872|NCT01539434|"~     The purpose of this study is to investigate to what extent patients with COPD, who have~     participated in physical training for 12 weeks, can maintain their physical activity~     behaviour and physical capacity on a long-term basis if they get a behavioural medicine~     intervention.~   "
115873|NCT01539421|"~     This study was designed to evaluate the effectiveness of 12 weeks' home exercise training~     using the Nintendo ® Wii Fit system in patients with COPD. Following an initial pilot study~     at one institution to determine the physiological responses to exercise training using the~     home based interactive computer system, a longitudinal study was performed to evaluate~     outcomes across several areas. Outcomes were measured at baseline, after 6 weeks of standard~     care, and after 6 and 12 weeks of home exercise training. Three hospital based pulmonary~     rehabilitation centers in Connecticut participated in the longitudinal study.~   "
115874|NCT01539408|"~     Women diagnosed with incomplete abortion in this health facility will be randomized to~     receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or~     standard surgical treatment (MVA). The investigators hypothesize that treatment of~     incomplete abortion with misoprostol using 400 mcg administered sublingually will be as~     effective as surgical evacuation.~   "
115875|NCT01539395|"~     This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple~     Sclerosis.~   "
115876|NCT01539382|"~     The purpose of this study is to test whether keeping the amount of oxygen delivered to the~     brain above a certain level during surgery and 24-hours after surgery improves recovery.~      Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level~     during surgery and 24-hours after surgery improves cognitive and neurological outcomes after~     cardiac and aortic surgery.~      Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level~     during surgery and 24-hours after surgery helps reduce major organ problems after cardiac~     and aortic surgery.~      To test our hypotheses, the investigators will conduct a randomized control trial. Patients~     will be randomly assigned to one of two possible study groups. In the Treatment Group, the~     brain oxygen level will be watched by doctors and used to guide care in the operating room~     and the first day in the intensive care unit after surgery. Doctors will try to keep the~     brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and~     blood acidity levels, and blood count. In the Control Group, the doctors will not be aware~     of the brain oxygen level unless it falls below a level that may be dangerous. If a~     patient's brain oxygen falls below such a level, the doctors will adjust the blood pressure,~     carbon dioxide and blood acidity levels, and blood count to increase the brain oxygen level.~     All other procedures will be part of regular medical care and will be performed according to~     the standard of care.~   "
115877|NCT01539369|"~     The purpose of this parallel design study is to assess the relative effects of two 12-week~     healthy eating dietary interventions: general healthy eating (Diet A) and general healthy~     eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a~     large proportion of the fibre intake derived from cereal or wheat bran), in overweight~     low-fibre consuming premenopausal female adults on body weight change (kg). It is~     hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater~     weight loss and/or weight loss maintenance than following a healthy eating diet alone (Diet~     A).~   "
115878|NCT01539356|"~     A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of~     iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron~     retention in reticuloendothelial cells. The aims of this study were to determine serum~     hepcidin levels in preterm infants who receive blood transfusion and preterm infants having~     sepsis, in order to assess possible relationships between hepcidin and serum iron, serum~     ferritin,in iron load situations.~   "
115879|NCT01539343|"~     A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly~     into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter~     and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the~     CVC usually needs to be replaced.~      The goal of this clinical research study is to learn if an antimicrobial catheter lock~     solution can make it possible for the CVC to stay in place while treating an infection with~     antibiotics. The safety of the solution will also be tested.~      Your outcome will be compared to the outcome of patients who had the same type of infection~     but had their CVC removed.~      The antimicrobial catheter lock solution is made up of 3 chemicals:~      Minocycline and ethanol are designed to disinfect the CVC. Disodium~     ethylenediaminetetraacetate is designed to prevent the CVC from clogging.~   "
115893|NCT01539161|"~     The study Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients~     with Chagas Disease is a prospective, multicenter, randomized study that is being conducted~     at several centers in Latin America with commercially available products.~      The primary study hypothesis is that patients with implantable cardiac monitors will have a~     shorter time to the decision to treat for electrical or arrhythmic disorders during the~     follow-up period.~      The geography includes Argentina and Colombia.~   "
115880|NCT01539330|"~     The present study aims at measuring unbound voriconazole concentrations in plasma and at the~     relevant target site of systemic fungal infections, i.e. the interstitial space fluid of~     soft tissues, to assess the target site pharmacokinetics. For this purpose the microdialysis~     technique will be employed which is capable of measuring the unbound, microbiologically~     active concentration of antifungals in the interstitial space fluid of virtually all~     tissues. This is the first human study of this drug employing the microdialysis technique~     determining the target site concentrations over several days (single and multiple dosing).~   "
115881|NCT01539317|"~     The purpose of this protocol is to determine whether pain with sexual intercourse can be~     reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a~     non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.~      The investigators hypothesize that the pain arises in the vulvar vestibule. The~     investigators predict that the localized use of lidocaine will be more efficacious than use~     of placebo liquid.~   "
115882|NCT01539304|"~     Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry~     Syrup in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo~     Controlled, Parallel Designed, Multi-centered, Phase III Study.~   "
115883|NCT01539291|"~     This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension~     study that is a companion study to Study GS-US-312-0116, to evaluate the effect of~     idelalisib on the onset, magnitude, and duration of tumor control.~   "
115884|NCT01539278|"~     In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep~     apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the~     tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure~     the majority of children. However, for children with only a mild degree of OSA and few~     symptoms, surgery is less clear-cut, since two-thirds of these children do not develop~     worsening disease.~      Research shows that some children with mild OSA and behavior problems are helped by removing~     the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores~     on tests that measure quality of life (QOL).~      The investigators hypothesize that children with mild OSA will demonstrate changes on QOL~     assessment following adenotonsillectomy. These findings may help to guide the surgeon in~     selecting the children with mild OSA who are more likely to benefit from surgery.~   "
115885|NCT01539265|"~     The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary~     calculi patients.~   "
115886|NCT01539252|"~     The purpose of this study is to investigate the effectiveness of using two dialysers to~     lower the blood mineral levels in people receiving hemodialysis as compared to using one~     dialyser (usual treatment).~   "
115887|NCT01539239|"~     This clinical trial is a prospective, randomized, controlled, multicenter, study. After~     informed consent is obtained, patients will be evaluated for eligibility based on glaucoma~     severity, eye health, and visual acuity. Following successful screening, use of all topical~     glaucoma medications will be stopped for a period of washout to establish a qualifying~     medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over~     the course of the 24 month study, and examinations will be repeated to monitor eye health.~     At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be~     instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and~     afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The~     primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24~     months diurnal IOP following medication washout.~   "
115888|NCT01539226|"~     This is a double-blind, randomised, placebo-controlled study to assess the safety and~     efficacy of a silicone elastomer vaginal matrix ring.~   "
115889|NCT01539213|"~     The proposed exploratory study aims to understand the in vivo skin distribution properties~     of subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow~     microperfusion (OFM). The data of this study will help to understand the mode of action of~     AIN457 in its target tissue.~      It aims to establish a technique assessing in vivo distribution of AIN457 and its~     metabolites in human dermal interstitial fluid (ISF) and exploring a potential~     pharmacodynamic effect in situ. In addition, the study will further evaluate safety and~     local tolerability of subcutaneously administered AIN457 and explore dermal interstitial~     fluid skin levels of potential disease relevant biomarkers.~      The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the~     method is completed and Part II with 8 psoriasis patients will start based on the outcome of~     Part I.~   "
115890|NCT01539200|"~     Malnutrition and lack of regular exercise are often found in older adults and have been~     identified as important risk factors for independence loss and nursing home admission in~     older community-dwelling adults.~      Existing evidence suggests that high protein nutritional supplements can increase skeletal~     muscle protein synthesis following exercise in older individuals. However, increase of~     muscle strength by resistance training does not decrease the rate of falls and is not~     necessarily linked to an improvement of physical function. In contrast to resistance~     training, T'ai Chi, dance and eurhythmics have been shown to decrease fall incidence and~     improve mobility and physical function in older adults. The investigators will examine the~     combination of eurhythmics and high protein nutritional supplements.~      The aim of the study is to investigate whether there is an increase in normal walking~     velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze~     Eurhythmics training.~   "
115891|NCT01539187|"~     The purpose of this study is to establish the effectiveness and confirm the safety of the~     VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.~   "
115892|NCT01539174|"~     This phase II trial studies how well giving rituximab together with combination chemotherapy~     works in treating patients with previously untreated high- or high-intermediate-risk diffuse~     large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving more than one drug, combination~     chemotherapy, may kill more cancer cells. Giving rituximab together with combination~     chemotherapy together may be an effective treatment for DLBCL~   "
115894|NCT01539148|"~     The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to~     enroll in a five year Quality of Life clinical trial study in which the participant has~     previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat~     their illness. This study is a quality of life study and not a treatment study. Participants~     participating in the study will be asked to complete quality of life questionnaires. The~     questionnaires completed by the patients will measure mood, energy level, ability to~     function, level of pain, and other measures that indicate how a patient feels about the~     quality of their daily living.~   "
115895|NCT01539135|"~     Surgical patients have an endotracheal tube inserted into their windpipe to help them~     breathe while under general anesthesia. These tubes have a cuff on the outside that is~     inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come~     in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that~     has been shown in animals to decrease the leakage of fluid past the cuff better than a~     traditional tube that has a barrel-shaped cuff. This study is designed to examine whether~     the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past~     the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study~     will investigate whether the use of the TaperGuard tube is associated with a decrease in~     respiratory complications often seen following surgery which may be related to fluid leaking~     past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal~     tube will result in a decrease in fluid leakage past the cuff and that it will be associated~     with a decrease in respiratory complications during the 30 days after surgery.~   "
115896|NCT01539122|"~     The objective of this randomized controlled study is to obtain outcomes data on the Zimmer~     TM glenoid component by analysis of standard scoring systems and radiographs in comparison~     to the cemented glenoid component. In addition, the investigators plan to provide cost~     analysis based on the economic data collected to justify the cost difference between both~     implants.~      Patients with acceptable glenoid bone stock will be randomized into two groups to be treated~     with either a TM Glenoid or cemented glenoid component with minimum 2 years follow-up;~     maximum 10 years follow-up.~      Hypothesis: The early and long-term clinical outcomes and radiographic analysis of the TM~     glenoid components are superior to the cemented glenoid components in total shoulder~     arthroplasty patients.~   "
115897|NCT01539109|"~     The purpose of this study is to investigate whether combining a noninvasive method of brain~     stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of~     training of the affected upper limbs in patients with incomplete Spinal Cord Injury.~   "
115898|NCT01539096|"~     The purpose of this study is to investigate whether benefits of training the affected hand~     in patients with stroke can be improved by combining training with a painless, noninvasive~     technique called Transcranial Direct Current Stimulation (TDCS). TDCS will be applied over~     the part of the brain responsible for movements of the affected hand. Also, the~     investigators will study the changes in the brain that favor recovery of hand function~     following combination of training and tDCS.~   "
115899|NCT01539083|"~     The purpose of this study is to determine if bortezomib when added to consolidation~     treatment with thalidomide and prednisolone leads to an improved response in patients with~     multiple myeloma who have undergone autologous stem cell transplant and initial treatment~     with bortezomib, cyclophosphamide, and dexamethasone.~   "
115900|NCT01539070|"~     The purpose of this study is to develop, implement and evaluate an intervention focused to~     change feeding practices and patterns of physical activity of preschool children through~     providing motivational counseling to the mother. The aim is to prevent obesity in children~     aged 2 to 4 years 11 months with risk of overweight or with overweight.~   "
115901|NCT01539057|"~     Objective:~        -  To evaluate the efficacy of preoperative administration of fibrinogen in liver~          transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared~          with placebo, reflecting a reduction in the number of RBC units transfused during the~          procedure.~        -  To determine the influence of fibrinogen administration on mortality and survival of~          liver graft evaluated one year after the procedure.~        -  To determine the safety of fibrinogen administration recording thrombotic complications~          evaluated during hospitalization or at least 30 days postoperatively.~   "
115902|NCT01539044|"~     Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide~     better quality of muscle relaxation and rapid recovery from anaesthesia compared with~     intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.~      50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90~     minutes will be randomised into 2 treatment arms: CI-sugammadex & IB-Neostigmine.~      After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be~     started on rocuronium infusion immediately and rate adjusted according to the targeted PTC~     of 1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at~     reappearance of TOFC of 2.~      At the end of the surgery, the subject will be reversed with either sugammadex or~     neostigmine at different depth of block, ie PTC 1-2 and TOFC 2 respectively.~      Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique,~     CI-Sugammadex and IB-Neostigmine will be compared with respect to:~        1. Time to full reversal (T4/T1 [TOF] ratios ≥ 0.9) of neuromuscular blockade from:~             -  PTC 1-2 in CI-Sugammadex group~             -  TOFC ≥2 in IB-Neostigmine group~        2. Incidence of residual neuromuscular blockade (T4/T1 ratios < 0.9)~        3. Improved quality of intraoperative neuromuscular relaxation by maintaining profound~          neuromuscular blockade, as reflected by reduced incidence of intraoperative events and~          high VAS grading of relaxation quality by surgeon~   "
115903|NCT01539031|"~     The purpose of this study is to compare 23 mg donepezil sustained release to the currently~     marketed formulation of 10 mg donepezil immediate release in patients with severe~     Alzheimer's disease.~   "
115916|NCT01538862|"~     This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is~     effective as a treatment of Dystrophic Epidermolysis Bullosa (EB.) Patients will receive one~     course of treatment with the study drug. The course will be 7 days in length. After~     receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of~     the drug. Thirty day follow up can be done via telephone communication with the patient or~     family.~   "
115904|NCT01539018|"~     -  Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic~          Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated.~        -  According to the SHARP study subgroup analysis, it seems that HCV associated HCC~          patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib~          arm & the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).~        -  In spite of improvement in terms of overall survival (OS) and time to progression~          (TTP), in all studies where Sorafenib was compared to placebo, the Sorafenib arm was~          not accompanied by a significant volumetric reduction, and this may explains the lack~          of any symptomatic improvement (time to symptomatic progression (TTSP) almost~          identical)~        -  Reviewing the chemotherapy outcome, although there is no convincing evidence in~          survival benefit to patients with advanced HCC, however true shrinkage (reduction in~          tumor size), has been consistently reported although the magnitude of response is~          lacking consistency.~      This indicates the need for coupling Sorafenib to a chemotherapeutic agent but:~        -  For patients with Hepatocellular Carcinoma, the toxicity profile of any~          chemotherapeutic agent of choice to be added to Sorafenib should be take in~          consideration~        -  The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage &~          with minimal toxicity regarding:~        -  Cardio-toxicity~        -  HFSR~        -  Diarrhea~        -  Hepato-toxicity~        -  Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib,~          yet the HCC patients may have HCV related thrombocytopenia and variable degree of~          hypersplenism related pancytopenia)~      Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)?~        -  Efficacy: For UFT, although the efficacy data in HCC are not as extensive as~          Doxorubicin, however in one phase II study UFT could improve survival when compared~          with conservative management.~        -  UFT Toxicity Profile:~      In a phase III trial to asses the compare Efficacy & Safety of UFT with that of 5 FU in~     treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia,~     neutropenia, febrile neutropenia, thrombocytopenia & was 3% for anemia), while the most~     commonly seen SE was grade I & II Diarrhea~      •Accordingly UFT may be considered as a potential partner to Sorafenib in patients with~     advanced HCC.~   "
115905|NCT01539005|"~     This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence~     in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly~     active antiretroviral therapy (HAART).The primary objective of this study is to determine~     the incidence of TB recurrence in patients on HAART.The study is being conducted at the~     CAPRISA eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu~     Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No~     hypotheses will be tested in this study; however, the primary study question will determine~     the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402~     participants~   "
115906|NCT01538992|"~     Sympathetic system has important role occurrence of symptoms in heart failure. Renal~     denervation that is ablated some of sympathetic nerves is affected pathology of heart~     failure. This interventional therapy improves symptoms and life quality.~   "
115907|NCT01538979|"~     The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects.~     It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief~     off allergy symptoms over a two year study period.~   "
115908|NCT01538966|"~     In this study the investigators will evaluate whether combination low dose somatostatin~     receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of~     serum IGF-1 levels, compared to combination high dose SRL and weekly Pegvisomant. Lower~     doses of therapy will greatly reduce cost of acromegaly therapy.~   "
115909|NCT01538953|"~     This study is designed to evaluate the effect of different methods of drinking water~     treatment on the occurrence of diarrhea among children living in squatter settlements in~     Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260~     households will receive a new product which combines flocculation with chlorination to~     produce clearer, less chemically contaminated drinking water. 260 households will receive~     dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive~     soap and encouraged to wash their hands regularly. 260 households will receive both soap and~     the combination flocculation/chlorination water treatment. 260 households will continue~     their standard water treatment and handwashing practices. The households will be visited~     each week for 9 months, and the episodes of diarrhea from each child in the household~     recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months,~     households who were part of the standard habits and practice group will receive a water~     storage vessel and disinfectant.~   "
115910|NCT01538940|"~     This study will assess the efficacy of a new intradermal formulation of the trivalent~     inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected~     men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different~     formulations of influenza vaccine will be assessed by comparing immunologic responses to~     vaccine between the two study arms.~   "
115911|NCT01538927|"~     The aim of this randomized controlled clinical trial is to compare wound healing after the~     use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for~     their periodontal (gum)problems are selected and invited. Two regions will be operated in a~     selected patient. One region will receive fibrin sealant (test site) and the other region~     will get sutures (control site). Wound healing will be assessed by evaluating inflammatory~     markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.~      Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels~     of interleukin (1beta and 8) compared to use of sutures.~   "
115912|NCT01538914|"~     The purpose of this study is to compare the analgesic effect of paravertebral block with~     that of intravenous patient-controlled analgesia after video assisted thoracic surgery.~   "
115913|NCT01538901|"~     The purpose of this study is to compare two different therapies for actinic keratoses in~     organ transplant recipients with regard to efficacy and tolerability. The investiagtors are~     planning to examine treatment with Imiquimod 5% cream versus treatment with~     Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called~     photodynamic therapy, in this patients' group. A secondary objective of our study is to~     investigate the reduction in the field cancerisation after both treatments using~     fluorescence diagnostic method and digital imaging.~   "
115914|NCT01538888|"~     This study makes sure that the training of whole body vibration induces changes in~     ergospirometric parameters, in strength and influence in quality of life in healthy elderly.~     A case that is run like a vibration training combined, increasing strength and VO2.~   "
115915|NCT01538875|"~     Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure >~     110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication~     with severe and even deadly consequences. The management in this population had been~     studied, but no consensus has been reached with regards to which treatment is better. Our~     study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive~     crisis.~   "
115921|NCT01538797|"~     The objectives of the study were:~        -  To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect~          to their effects on basal- and food- stimulated gastric pH in healthy volunteers.~        -  To assess whether there is a relationship between the pharmacokinetics of YF476 and~          gastric pH in healthy volunteers.~        -  To assess the safety and tolerability of single doses of YF476 in healthy volunteers.~   "
115922|NCT01538784|"~     The objectives of the study were:~        -  To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.~        -  To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy~          volunteers.~   "
115923|NCT01538771|"~     Prospective, randomized and open label trial~      Hypothesis~        -  Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce~          infarct size and post-infarct pathologic left ventricular remodeling in patients with~          ST-segment elevation myocardial infarction.~      Methods~        -  Randomization into control group or treatment group~        -  Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via~          over-the-wire balloon system simultaneously with first balloon inflation and~          conventional treatment~        -  Control group : conventional treatment~      Endpoints~        -  peak CK-MB & troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr~        -  MRI at baseline : infarct size, area at risk and salvaged myocardium~        -  MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition:~          increase of end-diastolic volume index > 20% compared to baseline)~        -  safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis,~          ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding~          and urgent target lesion revascularization~   "
115924|NCT01538758|"~     Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain~     due to calcifying tendinitis. However, evidence for this treatment is lacking. The~     investigators expect that patients treated with us guided needling with corticosteroid~     injection compared with patients treated with only corticosteroid injections in the~     subacromial bursa have better clinical outcome after one year follow-up.~   "
115925|NCT01538745|"~     The purpose of this study is to compare the safety and effectiveness of intravenous low dose~     ketamine to the industry standard of morphine in regards to controlling acute pain in the~     emergency department.~      Both LDK and morphine have side effects. The amount and character of these side effects will~     be compared. Additionally, the degree of sedation or agitation will be specifically~     measured. The aim of this current study is to make this comparison and shift the evidence~     for LDK use from the anecdotal to the scientific.~   "
115926|NCT01538732|"~     This is a single center, prospective, open label, single arm, investigator initiated pilot~     study investigating the effect of alitretinoin on severe lichen planus with mucosal~     manifestations. The target population comprises patients with MLP for at least 3 months,~     with or without LP lesions on other areas of the skin, who are refractory to topical therapy~     and standard skin care, and who are otherwise in good health. Patients will be recruited at~     the outpatient clinic of the dermatology department, University hospital Zurich.The planned~     duration of the study is 2 years. A total of 20 patients will be included. Patients who meet~     enrolment criteria will receive 30mg alitretinoin, given orally as gelatin capsules, once~     daily for 24 weeks. Dose interruptions are permitted in response to adverse effects,~     consistent with use of retinoids and the product label.~      Most clinical evaluations will be performed every 4 weeks. A safety follow-up visit is~     planned 4 weeks after the end of treatment. Further follow-up visits will be conducted 16~     and 24 weeks after end of treatment in those patients meeting the primary endpoint~        -  Trial with medicinal product~   "
115927|NCT01538719|"~     Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin~     and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys~     and tissue fibrosis is widespread. SSc presents special problems for developing therapies~     due to the heterogeneous clinical presentation, the variability of disease progression and~     the difficulty quantifying the extent of disease. For most disease manifestations, treatment~     is primarily symptomatic and generally inadequate.~      This study will utilize a 4-gene biomarker of skin disease as the primary efficacy outcome~     in a short duration, placebo-controlled clinical trial of rilonacept, designed to provide~     preliminary data for a larger trial. These gene biomarkers should provide a strong surrogate~     for such trials in the future and, if IL-1 is indeed the cytokine leading to fibrosis in~     this disease, provide a highly significant start to finding a therapeutic for SSc that for~     the first time might dramatically affect fibrosis. A central hypothesis of this study is~     that IL-1 inhibition will downregulate the 4-gene biomarker over a relatively short period~     of time, much shorter than is historically thought necessary to see changes in the MRSS, a~     skin score measurement tool. Entry criteria will include the recent onset of diffuse~     cutaneous SSc as this is the population most likely to show progressive skin disease and~     also the population examined in previous studies showing correlations between MRSS and the~     4-gene biomarker.~      Secondary outcomes will include other validated measures of SSc disease activity. MRSS and~     SSc health assessment questionnaire (SHAQ), will be followed during the trial. This study~     will also test the effect of rilonacept on global skin gene expression using microarray~     analyses of skin biopsies. In addition, serum biomarkers of SSc disease activity (COMP,~     THS-1 and IFI44) and a biomarker of inflammasome activation (CRP) will be tested before and~     after treatment.~   "
115928|NCT01538706|"~     The purpose of this non-randomized controlled intervention study was to evaluate the effects~     of a hospital-based home care program for children with cancer at a university hospital in~     Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit~     or an in-patient admission without increasing the incidence of adverse events and costs.~     Furthermore, to enhance the children's quality of life and the psychosocial impact on the~     family.~   "
115929|NCT01538693|"~     The purpose of this study is to determine whether exercising (walking) at different~     intensities increases levels of factors in the blood and saliva that are known to impact~     neuroplasticity (how the connections in the spinal cord and brain can change) and if these~     levels are changed by pairing exercise with a single dose of commonly used prescription~     drugs or by your mood.~   "
115930|NCT01538680|"~     This is a phase III B, prospective, interventional, open-label, single-arm, multicenter~     study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who~     have failed after standard therapy and for whom no therapy alternatives exist, in the time~     between positive results and approval / availability on the market, and to collect safety~     data for regorafenib until market access.~      Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase~     inhibitor targets certain key proteins that are essential for the survival of the cancer~     cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The~     growth of the tumor may be decreased by preventing these specific proteins from functioning.~      The primary endpoint of this study will be safety.~   "
115931|NCT01538667|"~     The purpose of this study is to characterize variability and extent of the deposition of~     ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with~     chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg~     active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be~     evaluated. In this study the radiolabeled substance will be administered and scintigraphy~     imaging techniques will be used to demonstrate the lung deposition visually. In the healthy~     subjects an additional pharmacokinetic method is used to calculate lung deposition~     indirectly based on pharmacokinetic data derived from plasma. For this purpose they will~     inhale at a separate occasion another dose of ciprofloxacin after having ingested activated~     charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the~     inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the~     blood (charcoal block). Safety investigations will focus on local tolerability in the lung.~      Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of~     the study drug.~      Results from this study will be used to show how the drug is distributed in the human lung.~   "
115932|NCT01538654|"~     The purposes of the esperience is:~        1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF~          )performed in cycles of ten days/months for six months~        2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance,~          polmonary function tests and metabolic pattern)~        3. to verify the weight mantainance after 6 months from the treatment suspension~   "
115933|NCT01538641|"~     Study Proposal:~      Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol,~     Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior~     activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin~     is more attractive and should be explored in this group of disorders. Based on these data~     and considering the advantage of its favorable toxicity profile, we propose a phase II study~     in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including~     peripheral T-cell lymphomas which are known to have a poor outcome when compared with~     equivalent aggressive B-cell lymphomas.~   "
115934|NCT01538628|"~     The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel~     is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)~     and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation~     exposure to the anterior rectum.~   "
115935|NCT01538615|"~     The goal of the proposed project is to see if an innovative family-based intervention can~     reduce childhood obesity by actively engaging the whole family in promoting healthy~     behaviors in the home. In additions, the project will also examine how the HOME Plus family~     intervention influences children's dietary intake, frequency of family meals, availability~     of healthy and unhealthy foods in the home and served at meals and snacks, and screen time~     (TV, game systems). The study will provide important information on strategies that families~     can use at home to prevent obesity.~   "
115936|NCT01538602|"~     Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and~     hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia~     and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased~     long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume,~     the thromboxane A2 level and the PCOS, an observational study was planned. Clinical~     evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.~   "
115937|NCT01538589|"~     This study is conducted in Japan. The aim of this study is to evaluate the incidence of~     severe hypoglycaemia under normal clinical practice.~   "
115938|NCT01538576|"~     This study is conducted in Japan. The aim of this study is to collect safety and efficacy~     data when using insulin aspart in children with diabetes under normal clinical practice~     conditions.~   "
115939|NCT01538563|"~     The primary purpose of this study is to determine the highest dose of ON 01910.Na that can~     be safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to~     patients with advanced solid tumors.~   "
115940|NCT01538550|"~     The Norwegian government has funded a pilot study of a national colorectal cancer screening~     programme. This implies initiation of a screening pilot in the catchment area for two~     hospitals in Norway. The target population is average risk men and women at age 50-74 years.~     The programme is designed as a comparative effectiveness programme evaluating acceptance and~     test performance for two screening methods - fecal occult blood testing (FOBT) and flexible~     sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary~     resources and the expected effects.~   "
115941|NCT01538537|"~     The primary objective of this study is to determine the largest dose of ON 01910.Na~     (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2~     weeks (2-week cycle) in patients with advanced cancer.~   "
115942|NCT01538524|"~     Patient safety is a great concern for the whole society. Since the investigators have a~     leadership in the medical field in Taiwan, the investigators should be courageous to face~     the reality from the patients seeking second opinions undergoing orthodontic treatment.~      Orthodontics just became a recognized specialty by the Department of Health in Taiwan in~     2009. It is just a beginning to set up the training course criteria at the national level.~     It will be a good timing for us to look at the treatment quality when patients seeking~     second opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic~     expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills,~     or a simple communication problem, depend on a good systemic analysis from the records and~     questionnaire collected in a timely fashion.~      The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment~     and seeking second opinion to join this study. The investigators will thoroughly explain to~     patients before they agree to take records and fill in questionnaire. Then the investigators~     use these records to perform root cause analysis.~      Our hypothesis is that the risk of adverse event (AE) is related to the training quality,~     communication skills, patient's understanding and compliance. From these results, the~     investigators shall be able to assess the risk of AE and make the education policy either at~     continued education level or special training courses towards a patient satisfied treatment.~   "
115943|NCT01538511|"~     This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin~     aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin~     aspart 30 (NN-X14Mix30) in healthy volunteers.~   "
115944|NCT01538498|"~     -  Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian~          cancer, tubal cancer and primary peritoneal cancer that can represent perioperative~          intraperitoneal tumor burden objectively~        -  Secondary objectives: To establish the relationship and find out clinical significance~          between PCI, tumor location and tumor characteristics~   "
115945|NCT01538485|"~     In this pilot study the investigators aim to investigate the effects of vitamin D~     supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women~     and men.~   "
115946|NCT01538472|"~     The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and~     rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood~     or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease~     the chances of the cancer coming back.~   "
115947|NCT01538459|"~     The purpose of this study is to determine the Finger Blood Glucose (sugar) when~     dexamethasone is added to a local anesthetic for a shoulder nerve block procedure. The~     investigators hypothesize that there is no increase in plasma glucose when 8 mg of~     dexamethasone is used as an adjuvant with local anesthetic to interscalene regional~     anesthesia. By performing finger stick blood glucose measures pre/peri and post operatively~     the investigators will be able to determine if any such increase exists.~   "
115948|NCT01538446|"~     The purpose of this study is to demonstrate the superiority of a strategy of platelet~     monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders~     and up-adjustment of the dose of prasugrel in low responders as compared to a more~     conventional strategy of a fixed dose of 5 mg to every patient without monitoring~     (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular~     (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type~     definite), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).~   "
115949|NCT01538433|"~     This is a survey of factors which affect a pathologically defined early or delayed diagnosis~     of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed~     diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford~     classification of IgA nephropathy. The factors to be surveyed include health examination~     including urine test, socioeconomic status of patients including education,etc.~   "
115950|NCT01538420|"~     GLPG0492 is a selective androgen receptor modulator: the compound should help protect~     against (or help restore) muscle loss in case of immobilization (e.g. after orthopedic~     surgery) or due to aging (androgenic effect), but without anabolic effects (e.g. effect on~     testosterone). In the first part of the current study it will be tested whether GLPG0492~     given orally to healthy male volunteers increases the protein synthesis in muscle, as~     measured by the uptake into the muscle of intravenously infused phenylalanine.~      In the second part of the study, the effect of the compound on the hormone household in~     healthy, postmenopausal women will be assessed.~   "
115951|NCT01538407|"~     This is a longitudinal, randomized, controlled interventional multi centric study on the~     effects of lower leg strengthening exercise on quadriceps force during walking in people~     with knee osteoarthritis. At each study centre twenty subjects will be included, for a total~     of 40 participants. Subjects will be randomized equally (1:1) into 1 active arm and 1~     control arm.~      The objective of the study is to evaluate the effect of twelve weeks of quadriceps~     strengthening on the mechanical output of the quadriceps during locomotion. A secondary~     purpose is to explore the relationship between quadriceps strengthening and compressive knee~     loadings. The hypothesis is that quadriceps strength training will not change quadriceps~     force, power, and work in locomotion in people with knee osteoarthritis.~      Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power~     and work and knee compressive loads during walking. Explorative measures are isometric and~     concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and~     Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up~     test (maximum number of reps).~   "
115952|NCT01538394|"~     The purpose of this study is to assess the efficacy of smoking cessation by using~     varenicline as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine~     patches).~   "
115953|NCT01538381|"~     The general objectives are to evaluate the pre-operative activity and the safety of afatinib~     in head and neck cancer and to explore the different downstream molecular pathways to~     identify tumor response and resistance mechanisms. The results from this study can be used~     to conduct a larger trial that would allow us to confirm or validate the hypotheses~     generated.~   "
115954|NCT01538368|"~     The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is~     primarily performed by radiologists who only in some cases have experience with the~     interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is~     unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional~     endoscopic procedures might be necessary in an individual case or if an additional~     MRCP-interpretation by the endoscopist renders any clinical impact.~   "
115955|NCT01538355|"~     It is well accepted that nutrition as an environmental factor is involved in the~     pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic~     low glycemic load treatment to alter the course of multiple sclerosis (MS)? The~     investigators think yes there is. Primarily the investigators want to detect if these diets~     are feasible for MS patients. Therefore the investigators examine the impact of this dietary~     intervention on the health related quality of life for individuals after 7 days, 3 months~     and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological~     and immunological changes after 7 days, 3 months and 6 months in compare to baseline.~   "
115967|NCT01538199|"~     The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the~     PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD).~     TLT works by briefly delivering near-infrared (non-visible) radiations to the forehead. The~     radiations penetrate the brain and stimulate the cells & metabolism.~      Our goals are~        -  To assess the antidepressant effect of the TLT in depressed subjects.~        -  To assess the safety and tolerability of the TLT in depressed subjects~        -  To assess the acceptability of the TLT in depressed subjects~        -  To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary~          Study)~   "
115956|NCT01538342|"~     Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory~     caspases, cysteine proteases involved in the processing of many proteins, are activated.~     Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src~     family, develop an inflammatory syndrome with the characteristics of human psoriasis.~      To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the~     investigators intend to develop a clinical study to analyze the expression, cleavage and~     activity of Lyn and the activation of caspases from skin biopsies of patients with this~     disease.~      This study will be conducted on a cohort of patients with different forms of psoriasis~     (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated~     with chronic inflammation. Thus, the investigators will evaluate the expression and activity~     of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the~     level of caspase activation and apoptotic inflammatory.~      Thus, the investigators will verify that the cleavage by caspases of Lyn is associated~     specifically with psoriasis, as the investigators believe, or more generally to the skin~     inflammation. The investigators work would then define the cleavage by caspases of Lyn as a~     new potential marker of human psoriasis.~   "
115957|NCT01538329|"~     Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the~     early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This~     treatment is usually maintained for no more than the first few months of management, before~     resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more~     modern use of the drug is at a more advanced stage of PD when dyskinesia are already~     established and become disabling for the patients. There is no data between these two~     extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and~     the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia~     suggest that the early and prolonged use of amantadine in the early years of management,~     before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on~     long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism~     of brain plasticity-of the disease modification type.~      The primary purpose of this study is to demonstrate that early introduction of treatment~     with amantadine (200 mg / d) in the early years of therapeutic care, that is to say during~     the honeymoon of levodopa (early phase of disease <3 years of diagnosis <1 year of L-dopa~     and lack of complications of levodopa therapy) decreases the rate of subjects with abnormal~     involuntary dyskinetic movements after 18 months of follow-up.~   "
115958|NCT01538316|"~     The aim of the randomized controlled double-blind crossover trial is to evaluate the~     effectiveness of two dietary supplements containing polyphenolic phytochemicals~     (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of~     increase in prostate-specific antigen (PSA). In addition, secondary objective is to evaluate~     the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as~     indicators of the oxidative status.~   "
115959|NCT01538303|"~     The purpose of this study is first to evaluate absolute myocardial blood flow and resistance~     over time in the acute and sub-acute phase of myocardial infarction and second, to correlate~     these parameters to preservation of left ventricular function and long-term outcome.~   "
115960|NCT01538290|"~     The investigators want to validate two non-invasive devices for the determination of central~     blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).~   "
115961|NCT01538277|"~     The knowledge of the real-time contact force leads to a greater reduction in atrial~     fibrillation burden after pulmonary vein antrum isolation.~   "
115962|NCT01538264|"~     The investigators are studying the use of an advanced magnetic resonance imaging (MRI)~     technique for measuring blood flow into brain tumors. This technique does not use~     radioactive tracers, and it can provide high quality images that can be obtained in a~     standard MRI scanner.~   "
115963|NCT01538251|"~     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine~     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the~     proportion of patients with disease remission at the end of the 8 weeks of treatment. It~     will also aim to investigate capability of the treatment in the maintenance of remission~     after four weeks of treatment interruption; histological changes will be also evaluated and~     finally, improvement in the overall quality of life as measured by the Short Inflammatory~     Bowel Disease Questionnaire (SIBDQ)will be investigated.~   "
115964|NCT01538238|"~     Recent advances in understanding the biology and genetics of renal cell carcinoma (RCC) have~     led to major therapeutic implications. Von Hippel-Lindau (VHL) gene inactivation, present in~     the majority of sporadic forms of RCC, leads to a defective VHL protein, followed by an~     active transcription of hypoxia-inducible genes, including vascular endothelial growth~     factor (VEGF), platelet-derived growth factor (PDGF), c-kit, and others. However, the~     concept of VHL inactivation in RCC and the subsequent malignant phenotype is almost~     exclusively seen in patients with clear cell histology.~      The data about efficacy of VEGF receptor inhibitors for non-clear cell RCC (NCRCC) is rare~     until now. Recently, however, sunitinib and sorafenib showed its worth for NCRCC in extended~     access programs.1-3 Although it is not certain, the underlying mechanism of their action~     might lie in that papillary, chromophobe, and sarcomatoid type overexpress c-kit, which is~     also a target of both drugs and could therefore provide a therapeutic target for non-clear~     cell subtypes.4-7 Pazopanib is also a potent and selective, orally available, small molecule~     inhibitor of VEGFR-1,-2, and -3, PDGF-α, PDGF-β, and c-kit tyrosine kinases. It has been~     validated and licensed for advanced clear cell RCC (CCRCC).8 However, there is very few data~     about its efficacy for NCRCC.~      In this study, we try to evaluate the efficacy of pazopanib in metastatic NCRCC.~   "
115965|NCT01538225|"~     Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate~     cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with~     secondary or primary progressive Multiple Sclerosis (MS).~   "
115966|NCT01538212|"~     This evaluation of the efficacy and safety of AXONA will be a chart review carried out at 16~     practices in which AXONA has been prescribed for the treatment of patients with~     mild-to-moderate AD. Efficacy of AXONA will be assessed by comparison of patient status~     before and after initiation of treatment.~   "
117284|NCT01520857|"~     The purpose of the study is to assess whether spinal anesthesia is superior to the standard~     general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal~     hernia repair (TAPP).~   "
115968|NCT01538186|"~     This retrospective observational study included patients (pts) with percutaneous coronary~     intervention (PCI) of a de novo coronary bifurcation lesion in one German center between~     January 2008 - August 2011. The investigators included all consecutive patients where the~     side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.~      Two different methods were compared: group A represents patients with a simple strategy~     without any treatment of the side branch (SB). Group B consisted of patients where the SB~     was treated (PCI and/or stenting).~      For the treatment of bifurcation lesions we used the concept of provisional stenting,~     indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction <~     2. Final-kissing PCI was intended in all patients of group B.~      MACE during follow-up was evaluated in all patients.~   "
115969|NCT01538173|"~     In this prospective study we investigated the impact of an improved postoperative~     microcirculation and its effect of surgical side infections after breast reduction.~   "
115970|NCT01538160|"~     Lately the investigators found that patients with severe factor XI deficiency and inhibitors~     could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic~     agent. These results encourage us to apply this treatment in clinical trial setting to~     patients with severe factor XI deficiency undergoing surgery instead of blood product.~   "
115971|NCT01538147|"~     Restless Leg Syndrome is a common but not well recognized central nervous system disorder.~     It is more prevalent during pregnancy and, if present before pregnancy, can develop an~     exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the~     physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has~     been done trying to link both disorders.~   "
115972|NCT01538134|"~     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed~     against cell membrane phospholipids (antiphospholipid antibodies) can cause an~     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,~     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis~     includes the development of fetal growth restriction (diagnosed postpartum), but this was~     done without solid evidence of a relation between the two or using the most common form of~     fetal growth restriction diagnosis (ultrasound). Our study will try to add information to~     this particular point.~   "
115973|NCT01538121|"~     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed~     against cell membrane phospholipids (antiphospholipid antibodies) can cause an~     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,~     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis~     includes the development of severe preeclampsia before 34 weeks of gestation, but this was~     done without solid evidence of a relation between the two. Our study will try to add~     information to this particular point.~   "
115974|NCT01538108|"~     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's~     percutaneous transluminal angioplasty (PTA) Balloon.~   "
115975|NCT01538095|"~     This phase I trial studies the side effects and best dose of trebananib in treating patients~     with solid tumors that has returned after a period of improvement or does not respond to~     treatment, including central nervous system tumors. Trebananib may stop the growth of tumor~     cells by blocking blood flow to the tumor.~   "
115976|NCT01538082|"~     The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people~     of high risk, of 40 or more years and attended in the Primary Care. Evaluating the~     association between anxiety, depression, quality of life and the vital stressful events, and~     the development of the metabolic syndrome in general population.~      Our hypothesis is that population of the cohort with bigger degree of stress will develop~     earlier the metabolic syndrome.~      If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing~     in a future interventions on these factors of risk to prevent or to decrease the incidence~     of this syndrome in the Primary Care.~   "
115977|NCT01538069|"~     Introduction. Heart failure is the result of primary ventricular dysfunction followed by~     neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal~     and respiratory muscles, which determine their clinical and prognosis. Despite the~     advancement in treatment, morbidity and mortality remain high. Physical training appears as~     a therapeutic strategy, because most of its beneficial effects is by inducing changes in~     peripheral physiological changes resulting from heart failure. Associated factors that may~     contribute to its progression and worse prognosis, now beginning to be studied, such as~     sleep apnea, the diagnosis provides important prognostic information and a potential~     therapeutic option for these patients.~      Objectives. Demonstrate the benefits of physical training for patients with heart failure~     and sleep apnea, and compare treatment with CPAP alone and associated with the exercise~     program. Will also be assessed risk and adherence to physical training.~      Material and Methods. The design will be prospective, longitudinal, randomized consecutive~     patients. After screening and baseline evaluations the patients will be randomized into~     Group 1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical~     Training, n = 20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and~     3 months): Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual~     function (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and~     isokinetic testing). Physical training: aerobic and resistance exercises three times a week~     for three months. CPAP therapy:after polysomnography for titration with ventilator~     servo-assisted, and outpatient follow monthly, for three months.~   "
115978|NCT01538056|"~     The primary objectives of this study are to determine whether physician modified~     endovascular grafts are a safe and effective method of treating patients with elective,~     symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be~     unsuitable candidates for open surgical repair and have no other options for treatment.~   "
115979|NCT01538043|"~     The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible~     mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).~   "
116015|NCT01537575|"~     Postpolio syndrome is a condition that affects many polio survivors years after the acute~     infection and causes symptoms to increase or new symptoms to develop. Proinflammatory~     cytokine production within the central nervous system (CNS) indicates an underlying~     inflammatory process, amenable to immunomodulatory therapy. In this study the investigators~     sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves~     the disease.~   "
115980|NCT01538030|"~     Premature rupture of membranes is an important cause of neonatal morbidity and mortality,~     mainly because of the complications associated with this pathology (oligohydramnios, cord~     compression or prolapse, infection). When rupture of the membranes occur the risk of cord~     compression increases but there is little evidence regarding this complication and amniotic~     fluid volume. The investigator's focus are the perinatal outcomes according to amniotic~     fluid volume (< 5 or >5).~   "
115981|NCT01538017|"~     Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's~     contracture affecting proximal interphalangeal joints. An open label, medico-independent~     randomized controlled trial.~   "
115982|NCT01538004|"~     The use of automated blood pressure measurement (ABPM) devices in the office setting is~     increasingly recognized as superior to manual BP measurement. Current guidelines recommend~     that patients be alone in a quiet room, with no interactions with health care professionals~     during the readings; in practice, this means using an exam room. However, we found no~     evidence supporting the location of ABPM. Furthermore, exam rooms are constantly being used~     in primary care offices, so this may not be practical in routine care.~      For this study, fifty consecutive consenting patients age 18 or more in each of seven~     community based primary care offices will randomly be allocated to either ABPM in an exam~     room, or in a non-private area of the clinic. After being tested in the first location they~     will then be tested in the second location with the same device. The main outcome will be~     the mean value of the last five systolic blood pressures for each location within offices.~     Secondary measures will include blood pressures for patients with or without hypertension, a~     comparison of the initial and second set of blood pressures and of the effect of office~     noise in decibels on BP readings.~      New technology is more readily adopted if barriers to use are minimized. If we find no~     differences in BP readings between office locations, clinicians will then have the option to~     use an additional office area to implement the automated BP measurement device.~   "
115983|NCT01537991|"~     The I-START trial is designed to determine the highest doses of radiotherapy that can safely~     be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are~     expected to live longer than three months and are fit to receive radical radiotherapy~     (radiotherapy given with curative intent) will be eligible to participate. All trial~     participants will receive 20 doses (called fractions) of radiotherapy. Evidence is available~     that suggests increasing the dose of radiotherapy given per fraction may improve both local~     control of the cancer and survival in some patients. However, high dose radiotherapy can~     damage normal tissues as well as the tumour. The dose of radiotherapy that can be used to~     treat lung cancer is limited by the normal tissues close to the cancer. For most of these~     normal tissues (lung, spinal cord and heart) the maximum safe radiotherapy dose that can be~     given is known. The maximum safe dose of radiotherapy for the oesophagus (gullet) is not~     currently known.~      The trial will be split into two parts:~        1. For those participants where the oesophagus will receive a high dose of radiation due~          to it lying close to the cancer, the first part of the trial will establish the maximum~          safe dose of radiotherapy to the oesophagus. The first group of participants will~          receive a slightly higher dose than is currently used to treat lung cancer. If these~          participants do not have any significant side effects, a second group of participants~          will receive a slightly higher dose than the first group. This process will continue~          incrementally until side effects from the treatment become evident, thus demonstrating~          the maximum dose that can safely be given. Once the maximum safe dose to the oesophagus~          is known this will be classed as the recommended Phase II dose and all further patients~          entering the trial will receive no more than this dose to the oesophagus.~        2. For those participants where the cancer is a safe distance from their oesophagus, the~          highest dose of radiotherapy that does not exceed the known safe dose limits of the~          normal structures (lung, spinal cord and heart) will be used.~      The findings of both parts of this study will determine whether increasing the dose of~     radiotherapy for NSCLC patients is a tolerable, safe and effective treatment. If the results~     are positive then this new treatment may be compared against the best currently available~     standard treatments in a future larger randomised (Phase III) trial.~   "
115984|NCT01537978|"~     The purpose of this study is to evaluate whether there are functional improvements in arm~     muscles and movments for spinal cord injured indviduals after performing video gaming.~   "
115985|NCT01537965|"~     The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now~     entering clinical practice. It is based on blood tests, especially FibroMetre® and~     Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory~     diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on~     the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive~     values , however, are far from be perfect in a given patient. With these technique, failures~     are also possible and the measures do not meet quality standards that increase the risk of~     misclassification. It would be particularly useful to have new generation techniques with a~     better diagnostic performance.~      In this project, in response to the problems presented above, we propose to evaluate the~     diagnostic performance of five innovative ultrasonic techniques for the non-invasive~     diagnosis of fibrosis.~   "
115986|NCT01537952|"~     Objective: Microbiologic etiologies of facial palsy in children were investigated.~      Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with~     facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were~     tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes~     putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and~     -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia~     burgdorferi, influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory~     syncytial-, coxsackie B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma~     gondii. Besides the routine tests in clinical practice, serum and cerebrospinal fluid~     samples were tested with a highly sensitive microarray assay for DNA of herpes simplex~     virus-1 and -2, human herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and~     varicella-zoster viruses.~   "
115987|NCT01537939|"~     ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to~     reduce the number of days employees spend being inactive.~      Study aims were:~        1. to have a minimum of 400 employee participants from each university site reach a level~          of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;~        2. to have 70% of the employee participants from each university site maintain two or~          fewer inactive days per week, defined as a level of less than 3,000 steps per day;~        3. to describe the socio-demographic, psychosocial, environmental and health-related~          determinants of success in the intervention; and~        4. to evaluate the effects of a pedometer-based walking intervention in a university~          setting on changes in self-perceived health and stress level, sleep patterns,~          anthropometric measures and fitness.~   "
116014|NCT01537588|"~     The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and~     apply that knowledge to the treatment and management of patients who undergo anterior~     cruciate ligament (ACL) reconstruction. There are three main components of this study:~        1. How do muscle shape, size, strength, and ability to function change following hamstring~          grafting for ACL reconstruction;~        2. How does physical activity change following ACL reconstruction;~        3. Is there a difference in outcome if graft harvest is done from the injured versus~          uninjured limbs~   "
115988|NCT01537926|"~     The purpose of the sudy is to conduct a small study to gather the preliminary data for~     future lage scale clinical studies that will be designed test the potential beneficial~     efffect of over-the counter study anti-oxidant drug called N-acetylcysteine (NAC) in~     patients with a heart muscle condition called Hypertrophic Cardiomyopathy (HCM). The present~     study is a pilot feasibility study, the investigators want to find out whether the~     investigators can recruit and retain patients with HCM in the study and whether these~     patients can tolerate this drug and can stay on one year. Likewise, the investigators want~     to find out any potential side effects that this drug might have and estimate whether ii has~     any beneficial effects.~   "
115989|NCT01537913|"~     Hypothesis: FOUR score is a better predictor of outcome (in hospital mortality and~     functional outcome at discharge) than GCS in children 5- 18 years age admitted in pediatric~     ward/ ICU with non-traumatic impaired consciousness.~      The assessment of comatose patients is an important part of critical care. The assessment of~     the level of coma relies on clinical scores. The Glasgow Coma Scale (GCS),remains the most~     commonly used scoring system for altered state of consciousness. Despite its widespread use,~     a number of limitations have been identified with GCS like inability to assess verbal score~     in intubated patients and non-inclusion of vital brainstem functions. The FOUR (Full Outline~     of UnResponsiveness) score, a coma scale consisting of four components (eye response, motor~     response, brainstem reflexes, and respiration pattern) was recently proposed by~     investigators from the Mayo Clinic.keeping in view the limitations of GCS, this study was~     planned to compare the new FOUR score with GCS as a predictor of mortality and poor~     functional outcome at hospital discharge.~   "
115990|NCT01537900|"~     The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver~     tissue to plasma PK after administration of grazoprevir (MK-5172) to participants with~     chronic hepatitis C virus (HCV) infection. Participants will be randomized to one of four~     different liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or~     72-hours after the Day 7 dose).~   "
115991|NCT01537887|"~     The purpose of this study is to evaluate the effect on the electrical activity of the heart~     as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to~     10 days of placebo in relation to a single dose of moxifloxacin. Information about any side~     effects that occur will also be collected.~   "
115992|NCT01537874|"~     This study evaluates the effectiveness of a motivational interviewing intervention with~     families with young children ages 0-5 where smoking is happening in the home to adopt a~     smoke-free home plan and reduce child's second-hand smoke exposure.~   "
115993|NCT01537861|"~     Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in~     patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for~     myeloma cells, depriving them of key support signals and rendering them more sensitive to~     chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore~     the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based~     treatment regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma~     and 2) to generate correlative data for a subsequent larger study looking at the~     combination.~   "
115994|NCT01537848|"~     This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided~     transmural drainage of post-operative collections during a 9 years period.~   "
115995|NCT01537835|"~     Healthcare worker uniforms are frequently contaminated with bacteria known to cause~     infections in humans. These bacteria are acquired during the workday. A new technology of~     antimicrobial textiles have been developed and incorporated into the fabric of health care~     worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature~     describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial~     properties in the clinical setting. Because of the potential benefit that such uniforms~     could offer HCWs and patients alike, further investigation into whether these fabrics are~     effective is warranted.~      Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the~     general internal medicine wards will be invited to participate in this study. Participants~     will be randomized to wear either uniforms (scrubs) that have antimicrobial properties or~     standard scrubs provided by the hospital. At the end of an 8-hour workday, three areas on~     each uniform and each subject's wrist area will be cultured to assess for total bacterial~     colonization as well as for various resistant bacteria such as methicillin-resistant~     Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant~     gram-negative rods.~      Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial~     contamination than standard uniforms (scrubs) at the end of an 8-hour workday.~      Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial~     contamination of sites swabbed compared to standard uniform after an 8-hour workday.~      Specific aim 1b. Demonstrate that antimicrobial uniforms will have less~     antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and~     resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour~     workday.~   "
115996|NCT01537822|"~     Rationale:~      The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps,~     myomas and placental tissue. It withholds some technical advantages over resectoscopy.~     Previous data suggest that it's a faster technique than the latter, and shows that it has a~     low complication rate.~      Objective:~      To compare the HM to bipolar resectoscopy for removal of:~      1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue,~     in terms of efficiency and complications.~      Study design: Single blind, randomized controlled multicenter trial.~      Study population: Women aged over 18 years old with:~      1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual~     placental tissue, who are planned for hysteroscopic removal.~      Intervention:~      Patients are randomized between removal with the HM or the bipolar resectoscope.~      Main study parameters/endpoints:~      Installation and operating time.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Women who are referred to our polyclinic will be seen on a first visit, and, according to~     the standard work-up, an ultrasound will be performed when intrauterine pathology is~     suspected. To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant~     diagnostic hysteroscopy will be performed consequently. Once the diagnosis is confirmed and~     surgery is planned, women will be asked whether they want to take part in this study. At~     this moment, both techniques are used in our hospitals and the choice of treatment depends~     on the preference of the gynaecologist. All women will be treated with operative~     hysteroscopy in a daycare setting according to the standard of care, only now randomized~     between the two techniques. A standard postoperative visit with ultrasound examination~     and/or ambulant diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative~     complications and complaints are recorded.~      It is expected that the HM beholds some advantages over the bipolar resectoscope such as~     shorter operating time and less complications (e.g. risk of perforation, current and fluid~     related complications). Previous data do not demonstrate any additional risks related to the~     use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine~     adhesion formation, as this might influence patient's fertility.~   "
115997|NCT01537809|"~     The purpose of this research is to determine what supplemental doses of vitamin D may be~     necessary to raise serum levels to optimal levels and how vitamin D supplementation and~     changes in vitamin D status impact cardiovascular risk factors in schoolchildren.~   "
115998|NCT01537796|"~     The purpose of this study is to examine the effect of an enhanced technology-based system,~     that involves a wearable device to measure calories burned combined with a website, in~     comparison to previous versions of similar technology and a standard behavioral weight loss~     on body weight across 6 months in obese adults.~   "
116762|NCT01527708|"~     Primary objective of this study was to assess the intrasession, intersession and~     interobserver variability of the Pentacam-derived curvature and zernike coefficients in back~     surface of normal, keratoconic and crosslinked corneas.~   "
115999|NCT01537783|"~     In this study, the investigators will enroll patients who present to the emergency~     department with abscesses to the study. The patients will be randomly selected to either~     have the standard of care, which includes the standard drainage of the abscess and then~     usually a follow-up visit to recheck the wound, or to have the standard of care plus~     instructions to use a topical scrub of a soap called chlorhexidine once a day for five days~     and twice daily application of a topical antibiotic ointment called mupirocin to the nasal~     passages for five days.~      The investigators will then call back the patients at 7 days, 14 days (if in the treatment~     arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation.~     The study hypothesis is that the patients who have undergone the decontamination protocol~     will have fewer subsequent infections.~   "
116000|NCT01537770|"~     The main purpose of this study:~      - to determine whether vertebroplasty has a pain palliating effect superior to a~     sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar~     spine.~      Secondary purposes:~        -  To determine if there are differences in the two methods on preventing forward tilting~          of the spine and/or shortening of the total height of the spine.~        -  measure if there are differences in change of lung capacity between the two methods~   "
116001|NCT01537757|"~     This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in~     participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931~     in participants with severe renal disease and in healthy matched control participants will~     be studied. If data from Part 1 confirms that severe renal impairment does not alter the~     pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study~     will be required and Part 2 will be optional. If the data does not support this conclusion,~     then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with~     moderate and mild renal impairment compared to healthy matched controls.~   "
116002|NCT01537744|"~     The purpose of this study is to determine whether 5-azacitidine in combination with~     romidepsin cancer are effective in the treatment of advanced solid tumors.~   "
116003|NCT01537731|"~     Previous studies have shown that chronic pain after hysterectomy is common. The aim of this~     study is to investigate the incidence of chronic pain after vaginal or laparoscopic~     hysterectomy for benign reasons. The aim of this prospective study is also to study the role~     of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.~   "
116004|NCT01537718|"~     The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized,~     longitudinal study.~   "
116005|NCT01537705|"~     A clinical outcomes study measuring reduction in pain and numbness experienced in four types~     of peripheral neuropathy patients during 60 day administration of the an amino acid~     formulation.~   "
116006|NCT01537692|"~     The purpose of this study is to compare the systemic levels of beclomethasone 17~     monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of~     BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in~     healthy volunteers.~   "
116007|NCT01537679|"~     The purpose of this study is to determine whether meditation will reduce stress and~     depressive of adult caregivers of a person with dementia.~   "
116008|NCT01537666|"~     The study is carried out to evaluate the safety, tolerability and pharmacokinetics of~     AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.~   "
116009|NCT01537653|"~     Primary Objective:~      Assess the safety and tolerability of SAR231893 (REGN668) after ascending single~     subcutaneous (SC) doses in healthy Japanese adult male subjects~      Secondary Objectives:~      Assess the following parameters after ascending single SC doses in healthy Japanese adult~     male subjects~        -  The pharmacokinetics of SAR231893 (REGN668)~        -  The immunogenicity of SAR231893 (REGN668)~        -  Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)~   "
116010|NCT01537640|"~     Primary Objective:~      To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893~     (REGN668) drug products after administration of a single subcutaneous (SC) dose~      Secondary Objective:~      To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug~     products after administration of a single SC dose~   "
116011|NCT01537627|"~     Several impairing factors contribute to physical limitation in chronic obstructive pulmonary~     disease (COPD) as deconditioning, muscle dysfunction and physical inactivity. The available~     literature clearly indicates that these therapeutic targets benefit from exercise training~     in patients with COPD and, currently, the key point is not whether patients should or not~     exercise, but which is the specific contribution of each exercise modality to this~     population. About this topic, the characteristics of a physical training program to be~     offered to patients have been a point discussed among researchers in this field, although~     recently the high-intensity training has been recognized as superior in comparison to the~     low-intensity training. Literature also indicates that, in order to change the sedentary~     lifestyle of patients with COPD, long-term training programs are indicated. However, a doubt~     still remains: if long-term programs are one of the key points to reduce physical~     inactivity, it is not yet clear whether it is necessary to include high-intensity exercises~     in that long-term program. If the duration is the only factor influencing the outcomes of~     the program, thus the intensity of training could be reduced, increasing the adherence of~     patients to the protocol. Based on this hypothesis, the aim of this study is to compare the~     effects of two physical training protocols in a long-term rehabilitation program (6 months)~     in patients with COPD: a high-intensity protocol (based on endurance and resistive training)~     and a low-intensity protocol (based on callisthenic and breathing exercises training). It is~     expected that the results of this study contribute to the scientific literature by~     demonstrating whether low- and high-intensity training contribute equally to change the~     sedentary lifestyle of patients after a long-term exercise program.~   "
116012|NCT01537614|"~     Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI~     colimycin either as an aerosol or after IV injection, the administration being separated by~     5 to 10 days intervals~   "
116013|NCT01537601|"~     Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary~     tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs~     in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has~     not yet been studied. Through a prospective randomised trial of children with posterior~     urethral valves the investigators wish to determine the effect of circumcision on the risk~     of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other~     will be on antibiotic prophylaxis plus circumcision performed at the time of valve~     resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6,~     12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological~     renal function will also be monitored. The relative risk of presenting a febrile UTI in each~     group will be determined. Clinical, radiological and antenatal data concerning each child~     will be analysed. At 24 months follow-up, an impact on family scale survey (IOFS) will be~     proposed parents.~   "
116017|NCT01537549|"~     Studies have shown that alpha-lipoic acid and L-acetyl carnitine may have some~     neuroprotective activities and it is hoped that they could be helpful for people with~     neurodegenerative illnesses such as progressive supranuclear palsy (PSP).~      The purpose of this study is to find out whether the nutritional supplement alpha-lipoic~     acid/L-acetyl carnitine is safe and well-tolerated in individuals with PSP when given daily,~     and whether it affects their well-being, brain scan measurements and blood tests that~     measure the energy metabolism in cells.~   "
116018|NCT01537536|"~     The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as~     measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of~     weekly paclitaxel. This is a prospective single-center study that will investigate the~     activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast~     cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant~     chemotherapy).~   "
116019|NCT01537523|"~     The early community-care program is well-known rehabiliation for the fracture hip patient.~     For the discharged fracture hip patient from hospital, it is worth to investigate the effect~     of early mobilization program to improve their physical and psychological aspects.~   "
116020|NCT01537510|"~     Childhood obesity is highly prevalent and is associated with both short- and long-term~     adverse outcomes.~      Despite availability of guidelines for nearly a decade and more recent comparative~     effectiveness research (CER) evidence, the health care system has been slow to adopt~     recommended practices. Although pediatric health care providers often cite barriers such as~     limited time, skill, and resources, a frequently overlooked barrier is the lack of data~     systems to efficiently and accurately assess guideline implementation and to improve quality~     of care for childhood obesity. Health information technology (HIT) offers potential for~     accelerating the adoption of CER evidence regarding childhood obesity screening and~     management, for establishing treatment benchmarks, and for supporting patients and their~     clinical teams in care improvement. Incorporation of HIT may be especially effective if~     augmented by outreach to parents and children.~      The goal of this study is to develop and test system-level interventions to accelerate the~     adoption of CER evidence on childhood obesity screening and management, and ultimately~     improve obesity-related health care quality and outcomes. To achieve this goal, the~     investigators will work with two health care systems in Massachusetts with strong track~     records of research collaboration: Cambridge Health Alliance (CHA), an integrated academic~     public health system, and Harvard Vanguard Medical Associates (HVMA), a large multi-site~     group practice. Both systems use an electronic medical record for all aspects of ambulatory~     care, including point of care services such as electronic order entry and centralized~     functions such as patient scheduling.~      In these settings of innovation and commitment to improving quality of care, the~     investigators will develop and test two systematic strategies for adoption of CER evidence.~     The first incorporates computerized point of care decision alerts to pediatric primary care~     providers during routine office visits, linked to CER-based algorithms of care. The second~     augments this HIT approach with direct-to-parent communication of child's body mass index~     (BMI) along with recommended evaluation and management. The specific aims of this study are:~        1. In 18 community health centers of CHA, to identify barriers to and facilitators of~          adoption of an existing set of computerized point of care decision alerts for childhood~          obesity screening and management. The investigators will achieve this aim through~          in-depth interviews and surveys with primary care clinicians, which will inform the~          design of the investigators proposed intervention.~        2. In 14 practices of HVMA, to conduct a cluster-randomized controlled trial to examine~          the extent to which computerized point of care decision alerts to pediatric primary~          care providers, with or without direct-to-parent communications, will increase adoption~          of CER evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥~          95th percentile. The investigators will determine the extent to which each of the 2~          intervention conditions, compared with the usual care control condition and with each~          other, results in:~             1. Increased screening and assessment of childhood obesity at the point of care,~               including BMI, blood pressure, and laboratory screening, and provision of~               nutrition and physical activity counseling,~             2. A smaller age-associated increase in BMI over a 1-year period, and,~             3. Improved specific dietary, physical activity, and sedentary behaviors over a~               1-year period.~        3. To evaluate each intervention's costs (including clinician and family time) and~          cost-effectiveness in terms of children's change in BMI and weight-related behaviors.~        4. To develop a detailed dissemination guide to further accelerate adoption of CER~          evidence on childhood obesity in practices and communities interested in implementing~          similar interventions.~      To achieve the investigators aims, the investigators have assembled a research team with~     extensive experience in obesity prevention, clinician and child behavior change, clinical~     informatics, statistical methodology in cluster randomized controlled trials,~     cost-effectiveness analyses, and dissemination science. If successful, this project will~     provide new and sustainable approaches for accelerating adoption of CER evidence for~     childhood obesity screening and management and for improving quality of care for childhood~     obesity in pediatric primary care.~   "
116021|NCT01537497|"~     The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of~     PF-05175157 in a dose-dependent fashion in healthy volunteers~   "
116022|NCT01537484|"~     The purpose of this study is to verify the efficacy of an 8-week course of manualized~     Swedish massage for reducing pain and increasing function compared to light-touch bodywork,~     and usual care, in 222 adults with OA of the knee.~   "
116023|NCT01537471|"~     The purpose of the investigators research is to test whether problems people have with~     processing their senses (feeling overwhelmed, distracted or upset by sounds and other~     stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines,~     which are medicines used for things like allergies, sleep problems, or the common cold.~   "
116024|NCT01537458|"~     Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is~     known to cause significant morbidity and mortality, no good guidelines are available to~     guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with~     mitral valve repair. Treatment options for isolated repair have not been investigated~     thoroughly.~      The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve~     repair, performed in our center. By doing this, the investigators want to evaluate~     predictors of outcome after repair.~   "
116025|NCT01537445|"~     The purpose of this study is to evaluate the beneficial effect of pancreas transplantation~     for long term kidney function in patients undergoing single-pancreas transplantation.~   "
116026|NCT01537432|"~     This study is designed to evaluate the proportion of patients achieving reversal of chronic~     plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered~     subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive~     multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.~     Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to~     better understand, why secukinumab may be effective in psoriasis patients.~   "
116027|NCT01537419|"~     This study will evaluate the efficacy of attachment based family therapy (ABFT) for~     treatment of suicidality in adolescents. The study will compare 16 weeks of treatment with~     ABFT to a control condition Family Enhanced Non-directive Supportive Therapy (FE-NST).~   "
116028|NCT01537406|"~     The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years~     after the delivery of the radiation treatment, and to compare the frequency between subjects~     that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received~     standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast~     compared to the non-treated breast, will be assessed. Also, the occurrence of delayed~     radiation treatment side effects including tiny red vessels in the skin, breast indurations~     (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin~     dryness will be captured.~   "
116029|NCT01537393|"~     The purpose of this study is to determine if the 3-year graft failure rate following~     endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14~     days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or~     fewer days are used.~   "
116030|NCT01537380|"~     With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a~     chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal~     complications. The risk of mortality and morbidity are directly proportional to the~     importance of overweight and medical treatment alone is only moderately effective weight~     loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body~     mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection~     (SSI). The SSI are the third most common nosocomial infection after urinary tract infections~     and airway. The fight against the ISO requires the administration of antibiotic prophylaxis~     acting on the main bacteria found in bariatric surgery. There are several studies in the~     literature interested in the dose of cefazolin in bariatric surgery. However, no published~     pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic~     concentrations of cefazolin higher than minimum inhibitory concentrations of the main germs~     encountered in these surgery. Only empirical recommendations are published, including the~     SFAR and the National Institute of Health in 2010. This study aims to determine whether the~     dose of 4 grams of cefazolin can achieve these goals of concentration and estimate an~     injection time of preoperative ideal for an adequate tissue concentration at the time of the~     incision.~   "
116042|NCT01537224|"~     The role of the basal ganglia in the processing of information with emotional or~     motivational content has been demonstrated by several lesion and functional imaging studies~     in humans and animals. Deep brain stimulation surgery provides an opportunity to study these~     structures in humans in electrophysiological terms. The aim of this study is to investigate~     modifications in the electrophysiological activity of the subthalamic nucleus (STN) during~     the perception of auditory and visual stimuli with emotional or motivational connotations in~     patients with Parkinson's disease who have just undergone implantation of a deep brain~     stimulator in the STN.~   "
116031|NCT01537367|"~     PROJECT OVERVIEW~      This research is a collaboration between the Centers for Disease Control and Prevention~     (CDC), the Health Resources and Services Administration (HRSA), and six~     university-affiliated HIV clinics in the United States.~      Study title: Intervention Trials to Retain HIV Patients in Medical Care~      Study sites: The study will be performed at six HIV clinics affiliated with academic medical~     centers.~      Objectives: Using HIV patients' clinical data (without personal identifiers) routinely~     archived in electronic databases at the six participating clinics do the following:~      • To examine the extent to which a client-centered intervention delivered by trained~     interventionists (Phase 2 trial of the project) improves patient attendance for HIV primary~     care over and above the effect of the clinic-wide intervention. Phase 2 is a three-arm~     randomized controlled trial conducted at each of the participating six clinics. 300 patients~     will be enrolled in the Phase 2 trial at each clinic. One hundred will be new patients and~     200 will be patients with inconsistent attendance for HIV primary care at the clinic in the~     prior 12 months. Patients will be randomized to: (1) an enhanced contact plus behavioral~     skills arm or (2) an enhanced contact-only arm in which patients will receive a longer or a~     shorter client-centered intervention from two trained interventionists, or (3) the standard~     of care arm in which patients will receive the clinic-wide intervention and routine HIV~     clinical care only.~   "
116032|NCT01537354|"~     This is a null hypothesis study. The investigators hypothesize that there will be no~     difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute~     intervals after administration of either surfactant and there will be no differences in the~     number of doses needed between the two surfactants in premature infants admitted to our~     NICU.~   "
116033|NCT01537341|"~     Innovative advances in rehabilitation technology have created a split-belt treadmill capable~     of providing a much needed intervention aimed at limiting mobility disability. When~     desynchronized, the split-belt treadmill imposes demands on each leg such that the central~     nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing~     the split-belt treadmill, the investigators hypothesize this intervention can challenge the~     locomotor processes required for safe, efficient gait while concurrently providing an~     aerobic stimulus will produce favorable changes in physical function in older adults at risk~     for mobility disability.~   "
116034|NCT01537328|"~     The purpose of this study is to evaluate the effectiveness of a progressive resistance~     rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional~     rehabilitation program (TRAD).~      The investigators hypothesized:~        -  PROG will result in greater improvements in functional outcome measures such as: stair~          climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee~          Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).~        -  PROG will result in greater improvements in quadriceps muscle strength gains after TKA~          compared to TRAD.~        -  PROG will result in greater improvements in muscle mass and central activation compared~          to TRAD.~   "
116035|NCT01537315|"~     Presence of multiple traditional and nontraditional risk factors of atherosclerosis and~     cardiovascular disease (CVD) including inflammation in patients with chronic kidney disease~     (CKD) contribute to high CVD morbidity and mortality in this patient population.~     Additionally, the traditional approaches towards the therapy of CVD have little impact on CV~     mortality in these patients. Hydroxychloroquine (HCQ) used as anti-inflammatory in~     rheumatological disorders, has multiple beneficial properties relevant to the process of~     vascular disease. The effects of HCQ on atherosclerosis (AS) and vascular disease in CKD is~     not known yet. Thus, the study hypothesis is that HCQ treatment in individuals with CKD will~     provide clinically significant benefit in the management of CVD and will provide biological~     and functional atherosclerotic benefits.~   "
116036|NCT01537302|"~     Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted~     orientation while simultaneously crossing totally occluded femoropopliteal arteries.~   "
116037|NCT01537289|"~     A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with~     traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.~      There are no clinical data on tube-site pain. The investigators hypothesize that PC tube~     site pain is less than CT.~   "
116038|NCT01537276|"~     As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages~     including the lack of need for anesthesia, a non-invasive procedure with less cost and~     relative easy to put into practice. However, it would be failed to detect the extra-tubal~     and peritoneal pathology and would be also difficult to distinguish the obstruction caused~     by the spasm of intramural segment. Obviously, imaging quality plays a key role in~     diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the~     fluoroscopy were reported a higher sensitivity and specificity than those only taken two~     images in the examination. And hybridized radiography with CT or MRI system may provide the~     good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect~     the tubal patency in real time, can show pelvic pathologies better than HSG. However, no~     parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken~     more images can improving the diagnostic quality of the HSG. The aim of this study is to~     evaluate whether the accuracy of HSG can be improved by real-time evaluating under the~     fluoroscopy.~   "
116039|NCT01537263|"~     The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by~     ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage~     (SAH).~   "
116040|NCT01537250|"~     The purpose of this study is to evaluate the safety, tolerability and population~     pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.~   "
116041|NCT01537237|"~     The purpose of this study is to compare rotational angiography (3DATG~     technology)intra-procedure (during the ablation procedure) with CT (x-ray) pre-procedure~     (before the ablation procedure) fusion to create an anatomical picture of a heart to help~     adequately guide an ablation procedure for patients with arrhythmias.~   "
116089|NCT01536613|"~     This study is conducted in Asia. The aim of this study is to review the safety and efficacy~     of biphasic insulin aspart 30 in post-marketing use.~   "
116090|NCT01536600|"~     This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate~     biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic~     agent (OHA) for type 2 diabetes management in routine clinical practice.~   "
116043|NCT01537211|"~     In older adults, poor circulation in the lower extremities leads to serious health~     complications including limb loss. In addition, individuals with dysvascular disease also~     suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An~     individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to~     assist with function, including a prosthetic knee and a prosthetic foot. Currently,~     dysvascular amputees are given a prosthetic knee based on the basic expectation that they~     will be functionally stable. This consideration does not address higher levels of function~     like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not~     able to counteract their co-morbidities with a more active lifestyle. Walking is less energy~     efficient; their traditional prostheses may cause early onset of fatigue and induce a fear~     of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk~     on different surfaces and at multiple cadences through better control in swing and stance~     phases of gait. The impact of the functional differences in the prostheses is not clear and~     requires additional investigation to clarify the choice of the most appropriate functional~     prosthesis. The purpose of this study is to compare the functional outcomes with the~     traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.~   "
116044|NCT01537198|"~     Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual~     practice according to the approved Korean product label will be registered into this~     observational study. Baseline data will be obtained at enrollment including demographics,~     gestational age, birth weight and underlying diseases and complications especially in regard~     to respiratory disease and cardiovascular disease. At routine visits for Synagis~     administration, which will occur according to usual medical practice, information on Synagis~     prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days~     after the last administration of Synagis.~   "
116045|NCT01537185|"~     The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine~     (SPWCV) given with alum is safe and well tolerated by healthy adults.~   "
116046|NCT01537172|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053~     across ascending single and multiple doses in healthy adult male and female subjects.~      The secondary objective of the study is to characterize the pharmacokinetic profile of~     ONO-4053 in healthy adult male and female subjects.~   "
116047|NCT01537159|"~     The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI)~     scan of the bone marrow before the start of standard chemotherapy can predict complete~     remission of leukemia patients after the therapy. This type of MRI scan, called dynamic~     contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do~     not achieve complete remission status after initial therapy and will be treated with~     additional therapy, the investigators are also interested in determining if the second MRI~     exam before the additional therapy can predict complete remission. If successfully tested,~     the MRI exam may be used in the future to help with early identification of patients who are~     unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic~     plan to be developed for these patients at an early stage and prevent them from being~     exposed to toxic and ineffective therapies.~   "
116048|NCT01537146|"~     The purpose of this study is to elucidate whether patients operated with high tibia~     open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so~     that both healing and rehabilitation are served optimally.~   "
116049|NCT01537133|"~     There are new, very sensitive methods for detecting bacteria. These methods show that~     hundreds of millions of microbes (organisms that can only be seen with microscopes),~     especially bacteria, live in healthy people. The collection of different microbes found in a~     site is called a microbiome. The investigators know that microbiomes of the skin, sinuses,~     mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome -~     which bacteria are found in a site - may be necessary for good health. For example, the~     microbiome of the mouth is different in people with inflammation of the gums~     (periodontitis), and the microbiome of the bowel is different in people with inflammation of~     the intestinal tract (inflammatory bowel disease).~      The purpose of this research study is to find out if the microbiome in the lungs is~     different in healthy people without asthma compared to people with asthma. This study will~     also find out if the microbiome of the lungs changes when people with asthma take a daily~     controller medication called an inhaled corticosteroid.~   "
116050|NCT01537120|"~     This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool~     for the evaluation of both new and existing pharmacological treatments for type 2 diabetes,~     using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as~     a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral~     Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour~     weighted-mean glucose (WMG) relative to placebo.~   "
116051|NCT01537107|"~     This phase I trial studies the side effects and the best dose of sirolimus when given~     together with vismodegib in treating patients with solid tumors or pancreatic cancer that is~     metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth~   "
116052|NCT01537094|"~     Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated~     by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However,~     the role of micronutrients, such as vitamins, on GH secretion has not been investigated in~     much detail. Vitamin C levels are also reduced in obesity, and the investigators recently~     demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion~     in two preliminary retrospective studies. The investigators therefore propose a more~     detailed prospective physiological study to examine the effects of increasing dietary~     vitamin C intake on GH secretion in a physiologic, intervention study. The investigators~     hypothesize that increasing vitamin C concentrations in obese subjects with sub-optimal~     plasma vitamin C levels and reduced GH secretion will increase GH secretion.~   "
116053|NCT01537081|"~     The study is designed to meet regulatory requirement outside the US. The dosing regimen and~     assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not~     match approved Mucinex labeling in the U.S. The purpose of this study is to determine~     whether Mucinex is effective and non-inferior as compared to placebo and immediate release~     guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design~     was required based on EU regulatory guidance.~   "
116054|NCT01537068|"~     The investigators are studying a new antidepressant medicine, desvenlafaxine, for the~     treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been~     approved by the FDA for the treatment of major depression.~      The investigators are testing whether this medicine is also effective for adults with a type~     of chronic depression that is less severe than major depression. This condition is also~     known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years,~     often causes significant suffering and impairment.~      In addition, the investigators are using MRI imaging, which uses magnetic signals to make~     pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in~     this study is to see whether chronic depression is associated with differences in brain~     structure or functioning, and whether such differences change after medication or placebo~     treatment. To test this MRI scans are done at the start of the study and after 12 weeks of~     medication or placebo treatment. Getting MRI imaging will be an option for participants in~     this study but is not required.~      This study involves a 6 to 12 week double-blind period during which half of the participants~     will take the new medication and half will take a placebo (an inactive look-alike pill).~     After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved~     antidepressant medication.~      Assessments (of depressive symptoms, social functioning, and personality) will be done by~     study staff and by patients before the study starts, at each study visit for the first 12~     weeks, and again after 24 weeks in the study.~   "
116055|NCT01537055|"~     To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple~     therapy in the second line therapy for those who fail from one eradication therapy~   "
116056|NCT01537042|"~     This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in~     subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.~      The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to~     investigate the effect of Rotigotine on quality of life and sleep.~   "
116057|NCT01537029|"~     To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in~     participants who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I~     obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that~     participants who weigh more will have higher doxorubicin and cyclophosphamide clearances~     than participants who weigh less. Restated, the area under the drug-concentration time~     profile, also known as the AUC, in participants will decrease as participant weight~     increases.~   "
116058|NCT01537016|"~     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)~     treated with targeted interventions such as protease modulating therapies can improve~     clinical and economic outcomes.~      It is hypothesized that protease modulating dressings may provide significantly better~     clinical outcomes on EPA wounds over current standard of care.~   "
116059|NCT01537003|"~     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)~     treated with targeted interventions such as protease modulating therapies can improve~     clinical and economic outcomes.~      Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds~   "
116060|NCT01536990|"~     The purpose of this study was to investigate the reliability, construct validity, and~     sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected~     by stroke.~   "
116061|NCT01536977|"~     This pilot clinical trial studies early brief behavioral intervention in treating sleep~     disturbance and improving quality of life in patients undergoing bone marrow transplant~     (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and~     improve quality of life and cognitive function in patients undergoing BMT~   "
116062|NCT01536964|"~     Heart Attacks are a major cause of death in this country. When patients have a heart attack,~     they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is~     important that Prasugrel starts to work as quickly as possible following a heart attack. As~     many patients who have a heart attack experience excruciating pain, they are often given~     morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how~     Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We~     intend to study the effect of morphine on the absorption of Prasugrel.~   "
116063|NCT01536951|"~     This will be a 2-part, randomized, subject- and investigator-blind study in healthy males~     and females.~      Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that~     yields drug exposures slightly exceeding typical exposures anticipated from repeated~     administration of an efficacious dose to patients. The concentration of the drug in the~     blood stream will be measured and information about any side effects that may occur will~     also be collected.~      Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of~     the heart as measured by electrocardiogram (ECG) in relation to placebo following a single~     oral dose.~   "
116064|NCT01536938|"~     The purpose of this study is to investigate whether LEO 90100, calcipotriol and~     betamethasone are effective in the treatment of psoriasis vulgaris.~   "
116065|NCT01536925|"~     This research deals with behaviors that are part of opioid dependence. The purpose is to~     study the extent to which stress and other factors, including money and amount of work~     effort, affect opioid choice. Specifically, the investigators will examine the effects of~     three issues/factors. The first is how hard participants are willing to work to obtain an~     opioid drug; the second is how much opioid drug would participants choose instead of money;~     and the third factor is how much participant's opioid drug choices are influenced after they~     are administered the drugs yohimbine and hydrocortisone, both of which could produce~     stress-like symptoms.~   "
116066|NCT01536912|"~     More scientific information is needed about medical marijuana use among HIV positive~     patients. There is conflicting information about the use of marijuana, use of medical~     marijuana, and the associations between them and health status/health risk behaviors/health~     care utilization. In addition, it is not clear whether patients who participate in~     prospective clinical studies differ from participants who do not participate; if there are~     differences between those two groups, then this would limit generalizability of knowledge~     about these issues.~      The goal of this project is to describe the use of marijuana among HIV positive patients and~     its association with health status/health risk behaviors/health care utilization.~   "
116067|NCT01536899|"~     The investigators are interested in understanding personal factors such as medical~     conditions and mental health, as well as social and economic factors, that influence~     marijuana (and other substance) use in HIV-positive patients.~      Several alternative hypotheses will be evaluated in the proposed project:~        1. healthier patients may self-select marijuana use;~        2. marijuana use may be associated with consequences that create barriers to seeking~          healthcare;~        3. marijuana use may have medicinal value that reduces the need for such care.~   "
116068|NCT01536886|"~     The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus~     betamethasone are effective in the treatment of psoriasis vulgaris.~   "
116069|NCT01536873|"~     ING114916 is an open-label, multi-center, expanded access (EAP) study~   "
116070|NCT01536860|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycemic~     responses to a liquid meal tolerance test (LMTT).~   "
116071|NCT01536847|"~     The purpose of this study is to assess whether added food ingredient(s) affect glycemic~     responses to a liquid meal tolerance test (LMTT).~   "
116072|NCT01536834|"~     This is a non comparative pre-CE marking pilot clinical investigation is required to~     evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class~     IIa medical device for verrucas in the adult population. The treatment regime will be~     topical application of the Verruca treatment to the verruca, identified as the reference,~     once daily for 4 weeks.~      Patient & investigator derived outcomes will also be collected to assess clinical~     performance and adverse events and adverse device effects will be reported to assess safety~     profile.~      Patient assessments will take place pre-treatment to determine patient demography, baseline~     clinical status, pain and verruca size prior to treatment. Compliance with treatment~     schedule will be collected via patient diary cards. Furthermore, patients will be assessed~     on day 2 after starting treatment and then again at 7, 14, 21 & 28 days after starting~     treatment. Diary cards will completed through-out the investigation.~   "
116073|NCT01536821|"~     The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be~     important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene~     will often develop Parkinson's disease. Eligible participants will be asked to complete a~     single Study Visit at an affiliated research facility closest to their home.~   "
116074|NCT01536808|"~     The potential clinical implications of this study are to optimise the selection of a~     population at risk for developing a diabetic cardiomyopathy among diabetic patients in order~     to develop early therapeutic strategies to prevent the left ventricular remodelling.~      Therefore, the originality of this project is to hypothesize that :~        -  Diabetes mellitus is often associated with a premature aging syndrome~        -  Cellular senescence may potentiate the mechanisms that are involved in decreasing~          myocardial contractility in DM and,~        -  DM associated to premature aging may increase the risk of developing a cardiomyopathy~          Thus, the modulation of telomerase activity and the control of telomere length,~          together with the attenuation of the formation of reactive oxygen species, might~          represent important new targets in order to develop therapeutic tools in prevention of~          diabetic cardiomyopathy.~   "
116075|NCT01536795|"~     This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing)~     is more effective than WR279396 without occlusion for once daily treatment.~      Extensive objective and subjective local tolerance data will also be captured during this~     trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the~     deep dermis) that may help to determine the optimal number and duration of treatments.~      The results from this study will help determine the most practical treatment schedule and~     will answer questions that are crucial to improve the present treatment regimen with~     WR279396 which is twice a day for 20 days.~   "
116076|NCT01536782|"~     The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or~     pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated~     calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck~     undergoing chemoradiation therapy.~   "
116077|NCT01536769|"~     The cause of Parkinson's disease (PD) is unknown and a reliable biomarker to identify PD~     patients as early as possible is urgently needed. Nerve cells near the nose and in the gut~     become first affected in PD and patients frequently suffer from loss of smell and~     constipation. The nose and gut harbor very high amounts of bacteria that influence our body~     functions in many ways, even in the brain. The investigators are examining a possible role~     of bacteria of the nose and gut in the pathogenesis of PD. This may lead to a better~     understanding of what PD causes and may open new possibilities for diagnosis and treatment.~      The investigators will recruit 100 PD patients and 100 control subjects. The investigators~     will characterize all subjects carefully with respect to clinical symptoms. The~     investigators will collect bacterial samples from the nose, mouth and stool of these~     subjects. Using modern genomic techniques the investigators will read out the genetic code~     of all bacteria contained in these samples and will be able to identify which species of~     bacteria are present in the samples. Using complex cluster computing the investigators will~     compare the pattern of bacterial species between PD patients and controls and look for~     specific abnormalities in PD patients.~      If the investigators can detect specific differences of bacterial communities between PD~     patients and controls this may point to a role of bacteria as a cause of PD. Since there are~     many ways to influence bacterial communities pharmacologically (antibiotics, probiotics) it~     will be possible to investigate whether these therapies could alleviate or even reverse PD~     symptoms. Furthermore, the investigators would be able to use these differences as a~     biomarker which would enable us to develop a quick screening test for bacterial samples that~     may reveal whether a person has PD or not.~      By doing this study the investigators will learn whether bacteria play a role in the~     development of PD and whether the investigators can use them as a biomarker or therapeutic~     target. So hopefully the investigators will be able in the future to better understand what~     causes PD, how the investigators can diagnose it as early as possible and how to cure~     patients from PD.~   "
116091|NCT01536587|"~     This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects~     with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive~     Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with~     salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32~     subjects is planned to be enrolled.~   "
116092|NCT01536574|"~     This open label extension study allows assessment of the long term safety profile of REQUIP~     PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.~      Subjects must not have a break in study medication between completing the feeder study and~     entering extension study, treatment must be continuous.~      Subjects will be dispensed down-titration medication at the study completion/early~     withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after~     the last dose of study medication.~   "
116136|NCT01536002|"~     The objectives of this study are~        -  To determine PK of propofol in bariatric patients~        -  To identify the physiological variables that induce propofol PK changes in bariatric~          patients, when compared to a normal-weight population.~        -  To define context-sensitive half-time profiles for propofol in bariatric patients.~   "
116078|NCT01536756|"~     Evidence shows that depression was found to be associated with physical inactivity and on~     the other hand, high prevalence of depression was also found in patients with chronic pain.~     Structured physical rehabilitation program with exercises as main component and pain~     management provided by physiotherapy has been proved by overseas studies to be effective in~     reducing the psychological symptoms of depression through increasing the physical fitness~     and relieving the pain. Literatures also reported a strong sociocultural influence on the~     prevalence of depression and the manifestations of their clinical signs and symptoms in~     patients suffered from mental health problems between Chinese and Western societies. The~     benefits of physical rehabilitation program in the management of depression cannot be~     assumed in the Chinese population. The purpose of this study is to investigate the~     effectiveness of a structured Physical Rehabilitation Program for Chinese patients~     diagnosed with depressive disorder (mild to severe severity) on the physical fitness and~     negative psychological symptoms of the recruited patients.~      The Hypothesis are:~        1. The Physical Rehabilitation Program is effective in improving the physical fitness in~          Chinese patients with depressive disorders.~        2. The Physical Rehabilitation Program is effective in alleviating the negative~          psychological symptoms in Chinese patients with depressive disorders.~   "
116079|NCT01536743|"~     The purpose of this study is to obtain an estimate of the biochemical response rate as~     determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response~     criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125~     response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days~     after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125~     assessments).~   "
116080|NCT01536730|"~     The Centers for Disease Control and Prevention has declared that AIDS is a state of~     emergency in the US for African Americans - young African American men are especially~     vulnerable in this epidemic. Thus, the development of effective interventions tailored to~     this population is a national priority. The investigators previous preliminary studies~     suggest that a brief, clinic-initiated, home-based, self-guided condom use program may~     effectively promote the acceptance of condom use and increase the quality and consistency of~     condom-protected sexual behaviors. This pilot study will (1) develop and test the~     feasibility of this program (Homework Intervention Strategy, HIS) for young African American~     men attending an urban STD clinic and (2) identify variables that may mediate the efficacy~     of the program. The HIS has the potential to be readily translated into widespread practice,~     while requiring only minimal resources. Unlike previously tested interventions, the HIS can~     be applied to all men who use condoms, regardless of the sex of their partners or their~     HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed~     study will include a formative phase during which the basic intervention instructions~     which will be delivered by DVD will be refined and tailored for this population.~      One hundred young African American men recruited from an urban STD clinic will be randomized~     to each of two groups (HIS vs. standard of care) in a randomized 2-arm trial with 5~     assessment periods over the course of 6 months. Assessments will compare the groups on~     frequency of unprotected sex, quality of the condom use experience, experience of condom use~     errors and problems, attitudes regarding condom use, condom use acceptability, and condom~     use self-efficacy and confidence.~   "
116081|NCT01536717|"~     The purpose of this study is to examine the wound infusion of articaine for treatment of~     acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized~     design and an active control (bupivacaine)~   "
116082|NCT01536704|"~     To compare the bio equivalence of new nicotine lozenge formulation with the reference~     nicotine lozenge so as to deliver the same nicotine blood profile.~   "
116083|NCT01536691|"~     The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and~     Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for~     preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):~      Prospective multicenter, randomized, single blinded, phase III study.~   "
116084|NCT01536678|"~     GSK markets a drug called levothyroxine or T4 that is used to treat patients with~     hypothyroidism. Till date, the active drug substance or active pharmaceutical ingredient~     (API) for levothyroxine tablets marketed in India has been obtained from a particular~     source. GSK India proposes to change the source of the API from the existing source to a new~     source. Some patients may experience a change in clinical effect when switched from one~     formulation to another. Therefore this study is being done to understand whether a change in~     API in levothyroxine tablet has any impact on the clinical effect of the drug.~      The purpose of this study is to:~      See how quickly the levothyroxine tablet from the new source (single dose of 600mcg) enters~     the bloodstream, is distributed in the body, broken down and removed compared to the~     levothyroxine tablet from the existing source (single dose of 600mcg).~      Study the effect of single 600mcg doses of levothyroxine tablet from new source and~     levothyroxine tablet from existing source on TSH level in the blood.~      Study the safety and side effects of single 600mcg doses of levothyroxine tablet from new~     source and levothyroxine tablet from existing source.~   "
116085|NCT01536665|"~     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide~     adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects~     with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment~     with liraglutide or placebo.~      Subjects will initially be randomised to one of the three dose groups, and subsequently~     randomly allocated to one of two treatment sequences (liraglutide/placebo or~     placebo/liraglutide).~   "
116086|NCT01536652|"~     This study is conducted in Europe. The aim of this observational study is to document the~     glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic~     episodes, in patients that switched from insulin glargine combined with oral antidiabetic~     drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when~     applicable.~   "
116087|NCT01536639|"~     This study is conducted in Europe. The aim of the study was to evaluate the safety and~     efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix~     insulin analogue treatment compared to previous insulin regimen in routine clinical practice~     in the Slovak Republic.~   "
116088|NCT01536626|"~     This study is conducted in Europe. The aim of this observational study is to observe and~     investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic~     insulin aspart 30/70 (BIAsp 30) in an outpatient setting.~   "
116093|NCT01536561|"~     Phase I/II, single-center, dose-escalation study of the safety, pharmacokinetics, dosimetry,~     and efficacy of TST/I-131 TST for the treatment of patients with chemotherapy-refractory or~     resistant low-grade, intermediate-grade, or high-grade B-cell lymphoma. Subjects received 1~     to 3 dosimetric doses followed by a therapeutic dose of TST/I-131 TST. Study BEX104526 was a~     follow-up study of the long-term safety and efficacy data from the surviving patients who~     completed at least 2 years of follow-up following administration of TST/I 131 TST on Study~     BEX104728.~      Dosimetric dose: Subjects received 1 to 3 dosimetric doses of TST/I-131 TST, followed by a~     therapeutic dose of TST/I-131 TST. Subjects received various doses of unlabeled TST (0, 95~     or 475 mg) to determine the dose of unlabeled TST that optimized the radiation dose~     delivered to the tumor by TST/I-131 TST. The unlabeled TST was followed by 5 milliCurie~     (mCi) of I-131 TST. Serial whole body sodium iodide scintillation probe counts were obtained~     daily, for at least 5 days, in order to determine the rate of whole body clearance of~     radioactivity (residence time). The residence time was used to determine the radioactive~     clearance for the subject and the activity (in mCi) of I-131 required to deliver the desired~     TBD of radiation during the therapeutic dose. Because 475 mg was determined to be the~     optimal pre-dose of TST in the first subjects entered, the last 34 subjects received a~     single dosimetric dose that was preceded by an infusion of 475 mg of TST.~      Therapeutic dose: Groups of 3-6 subjects were enrolled at successively higher whole-body~     radiation dose levels beginning at a total body dose (TBD) of 25 centiGray (cGy). The TBD of~     each subsequent dose level was escalated by 10 cGy. Subjects who had undergone bone marrow~     transplantation (BMT) underwent a separate dose escalation (10 cGy TBD increase per dose~     level) beginning at a TBD level of 65 cGy. The MTD was defined as the highest dose level at~     which 0/3 or 1/6 subjects experienced dose-limiting toxicity (DLT). DLT was defined as~     follows:~      Any Grade 4 hematologic toxicity (National Cancer Institute [NCI] criteria) lasting greater~     than 7 days, or Any Grade 3 hematologic toxicity lasting greater than 2 weeks, or Any Grade~     3 or 4 nonhematologic toxicity Redosing. Subjects who achieved tumor regression were~     considered for re-dosing, using the original therapeutic dose of TST/I-131 TST, at the time~     the tumor was no longer shrinking in an attempt to upgrade their response.~      Retreatment. Subjects who achieved partial (PR) or complete response (CR) were considered~     for retreatment following relapse of their NHL, if progression occurred ≥6 weeks following~     the therapeutic dose. The original therapeutic dose of TST/I-131 TST was given unless a~     grade 2 or greater toxicity had been encountered, in which case a reduced dose was~     administered for the repeat therapeutic dose.~   "
116094|NCT01536548|"~     Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a~     button-hole technique is increasingly recommended. By using the same two sites for~     cannulation there are reports of less risk of complications and less pain for the patient.~     However, button-hole cannulation can be difficult for the dialysis nurse, and failing~     cannulations can damage the AV fistula and increase patient discomfort. The investigators~     therefore will test whether a simple marking on the skin of the direction and angle of~     cannulation used in each specific patient could improve the probability of a successful and~     painfree cannulation.~   "
116095|NCT01536535|"~     This is a multi-center, open-label study to determine the safety and effectiveness (how well~     it works) of two standardized treatments called mesalamine (Pentasa®) and prednisone in~     children with newly diagnosed UC. Standardized treatments are types of treatments agreed~     upon and used by many qualified doctors. The medications being used in this study are~     considered standard of care. Currently the ways in which these medicines are used (doses,~     frequency of dosing) may vary from site to site. This study will determine response to a~     standardized way of giving these medicines.~      This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that~     doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there~     is in the bowel, how the inflammation is produced, and whether the inflammation is~     responding to treatment. Collecting response and remission (free of symptoms) information on~     these standardized treatments and the biomarkers can possibly help doctors create a model,~     or plan to know which children with UC may respond quickly, or which children may develop~     complications.~   "
116096|NCT01536522|"~     The overall goal of the Asthma Inflammation Research [AIR] Translational Program is to~     create an integrated multidisciplinary team for the focused purpose of development of~     diagnostic and prognostic tests informative for airway inflammation, and for the design of~     innovative, targeted biologic therapeutics.~      The overarching aims of the AIR program are to conceptualize, develop, and test the~     next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will~     allow us to improve the standard of asthma care.~   "
116097|NCT01536509|"~     The purpose of the study is to test an online behavioral intervention to improve medication~     adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be~     monitored for four weeks to determine how frequently their child's IBD medication is taken.~     Patient's taking less than 90% of medications will be randomized to one of two intervention~     conditions to complete intervention sessions online. The study consists of 4 online~     intervention sessions with topics differing by condition and 5 online assessments to~     complete quality of life questionnaires over a 14 month time frame.~   "
116098|NCT01536496|"~     The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional~     coagulation testing for diagnosing and treating coagulation abnormalities in severely~     injured patients who are likely to require transfusion therapy.~   "
116099|NCT01536483|"~     Clinical management of very low birth weight newborns (VLBW <1250g) consists in several~     challenges to adapt immature physiological systems to extrauterine life. Advances in~     neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have~     significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract~     remains a major cause of morbidity due to~        1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and~          translocation),~        2. the complication of GI tract immaturity: intestinal perforation and enterocolitis~          necrotizing)~        3. the need of a prolonged parenteral nutrition and its complications (central venous~          catheter infections, sepsis, electrolyte disturbances) but without generate a high~          proof level on this targeted population (<1250g).~      The GI functions are progressively acquired during development and are largely sensitive to~     the environment, especially the intestinal luminal content. Indeed, probiotics and~     prebiotics have shown beneficial effects upon GI functions of newborns. One of the~     metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain~     fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic~     amount of butyrate increases gradually after birth. The beneficial effects of butyrate are~     related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant,~     barrier repair) and upon the enteric nervous system (network of neurons and glial cells)~     that regulate GI functions and in particular colonic motility.~      To date, there is no clinical consensus to manage digestive disorders of VLBW. Several~     clinical studies have assessed the effects of prokinetic drugs, dietary supplements~     (probiotics, prebiotics) but without generate a high proof level on this targeted~     population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant~     004) has shown benefit effects of oral probiotics supplementation in children with birth~     weight greater than 1000g but not in extreme preterms with birth weight less than 1000g.~      The main hypothesis to explain theses results lies in the intensive use of antibiotic and~     feeding interruption frequency in this targeted population which induce disturbances in the~     composition of the gut lumen (in particular the flora).~      Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate~     a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic~     mechanisms.~      Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a~     prospective randomized clinical trial blinded design.~      The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the~     nutritional management of extreme preterm less than 1250 grams, by facilitating the~     development of colic motility and clinical nutrition tolerance.~   "
116100|NCT01536470|"~     The purpose of this study is to evaluate whether a preventive strategy of intraoperative~     arterial hypotension using noradrenaline can reduce the incidence of postoperative organ~     failure.~   "
116101|NCT01536457|"~     There have been a number of studies which attribute causality between reflux disease and~     asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid~     suppressing medications (e.g. lansoprazole). However, clinical trials only recently have~     shed some light on this dilemma, with recent studies suggesting that the association is not~     as clear. This retrospective analysis of a prospective study which treated mod-severe~     asthmatics with lansoprazole or placebo will enter the collected raw data into a database,~     then perform statistical analyses to determine if children with asthma treated with acid~     suppression improved their asthma compared to those receiving placebo.~   "
116102|NCT01536444|"~     This case series will assess the use of suction blister epidermal grafts harvested by a~     novel device on select patients that have wounds from Mohs or excisional surgery.~   "
116103|NCT01536431|"~     The purpose of this study is to address the safety issue of whether, in patients with~     newly−diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely~     affects the rate of damage to the insulin making cells.~   "
116116|NCT01536262|"~     The primary objective of this study is to assess the safety of 52 weeks once daily treatment~     with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT~     Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
116117|NCT01536249|"~     This study will assess the effect of cimetidine on the pharmacokinetics (PK) of~     dexpramipexole in healthy volunteer and evaluate the safety and tolerability of~     dexpramipexole when given with or without cimetidine. Additionally, this study will explore~     the influence of genetic variation on the PK of dexpramipexole when given with or without~     cimetidine.~   "
116118|NCT01536236|"~     To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse~     Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.~   "
116104|NCT01536418|"~     This is a multi-centre, randomised, double-blind, active treatment, parallel group induction~     study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive~     one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for~     12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease~     Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI~     score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to~     qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary~     objectives will include assessment of the safety and evaluation of the efficacy in induction~     of clinical response or remission. Safety will be assessed by recording of adverse events~     and assessment of changes in clinical laboratory parameters, vital signs and~     electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A.~     Health outcomes assessments will include changes in Inflammatory Bowel Disease~     Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.~   "
116105|NCT01536405|"~     This study will compare the safety, tolerability, and immunogenicity of measles, mumps,~     rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with~     those of the 2006 process~   "
116106|NCT01536392|"~     The goal of this clinical research study is to compare granisetron (when given through a~     patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with~     cervical, endometrial, or vaginal cancer having chemoradiation.~      Granisetron and ondansetron are designed to help reduce nausea and vomiting.~   "
116107|NCT01536379|"~     Kidney transplantation is the best treatment for many patients with kidney failure.~     Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of~     immune system cells, including B cells, are active in rejection. B cells produce antibodies~     against anything the body sees as non-self, like germs or a transplanted kidney. Most~     medicines that help prevent transplant rejection affect cells other than B cells. Belimumab~     is a medication used to treat a disease called lupus. Belimumab slows development of~     antibody-producing B cells. This study will test whether belimumab works on parts of the~     immune system that cause rejection. Twenty to thirty adults getting a kidney transplant will~     be in this study. Like flipping a coin, a computer will randomly assign half to be given~     belimumab and half to be given placebo (a fake medicine). Patients and doctors will not know~     which medicine was assigned until the study is over. A total of 7 doses of study medicine~     will be given through a vein. One dose will be given during transplant surgery, and the~     other 6 will be given 2, 4, 8, 12, 16 and 20 weeks after transplant surgery. Usual~     transplant medicines will also be given. After all of the doses have been given, patients~     will be watched and tested at 24, 36, and 52 weeks after the transplant surgery. Blood~     samples will be tested to see what study medicines do to the immune system in transplant~     patients. If patients get a kidney biopsy, the samples will be tested to see if belimumab~     had any effect. Patients will be asked many questions to see if they are having any side~     effects. The study will be done at Addenbrooke's Hospital in Cambridge and Guys &St Thomas~     Hospital in London, United Kingdom. A pharmaceutical company, GlaxoSmithKline, is funding~     the study.~   "
116108|NCT01536366|"~     The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.~   "
116109|NCT01536353|"~     The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet~     in healthy male volunteers.~   "
116110|NCT01536340|"~     The purpose of this study is to:~      -Determine the incidence of adverse events, preventable adverse events, and ameliorable~     adverse events, and the timeliness of post-discharge ambulatory appointments, affecting~     urban and rural patients approximately 3-4 weeks after discharge from a hospitalist-run~     medical service of a large community hospital to home.~      H1: The incidence of post-discharge adverse events will be higher in rural patients compared~     with urban patients discharged from a hospitalist-run medical service of a large community~     hospital.~      -Identify and classify the types of post-discharge adverse events (e.g., adverse drug~     events, procedure-related events, hospital acquired (nosocomial) infections, falls, and~     other) affecting urban and rural patients approximately 3-4 weeks after discharge from a~     hospitalist-run medical service of a large community hospital to home.~      H2: All patients will be at higher risk for adverse drug events than other types of adverse~     events.~      -Examine the relationships between the population at risk, characteristics of the health~     care delivery system, and the utilization of post-discharge health services, and how these~     relationships help us understand the incidence of post-discharge adverse events.~      H3: Several factors will be independently associated with the incidence of post-discharge~     adverse events in rural and urban patients, including patient comorbidity, severity of acute~     illness, presence of a primary care physician prior to hospitalization, and a scheduled~     timely post-discharge ambulatory follow-up appointment.~   "
116111|NCT01536327|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     metachromatic leukodystrophy disease from plasma. Testing for clinical robustness,~     specificity and long-term stability of the biomarker.~   "
116112|NCT01536314|"~     The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2~     weeks before surgery induces a decrease of painful intensity 3 months after surgery,~     compared to placebo group.~   "
116113|NCT01536301|"~     The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared~     to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus,~     respiratory depression, urinary retention, allergies, hallucination) by 50% in adult~     patients operated on for prosthetic hip surgery.~   "
116114|NCT01536288|"~     Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance~     physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat~     fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are~     widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by~     human study. The investigators conducted a randomized, double blind, placebo controlled,~     crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.~   "
116115|NCT01536275|"~     In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the~     first week in critically ill children is beneficial, compared to the current standard of the~     early start of parenteral nutrition.~   "
116121|NCT01536197|"~     The investigators wish to study the effects of two forms of bariatric surgery, gastric~     bypass and lap banding. The surgery is not part of the clinical trial. If your insurance~     does not cover the procedure, then the patient is responsible for payment of the surgical~     process. The investigators are doing pre and post surgery testing to provide a better~     understanding of the effect of bariatric surgery-induced weight-loss on taste perception.~   "
116122|NCT01536184|"~     Study Summary: This study is being conducted in order to rigorously evaluate the real-world~     effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of~     Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes~     in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk~     for FASD, as delivered under routine practice conditions.~      Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list~     control group receiving standard services, the treatment group receiving COS will show~     greater improvement in caregiver behaviour, as well as child emotional and behavioural~     outcomes.~   "
116123|NCT01536171|"~     This experimental study will compare impact forces and metabolic cost in runners (N=20; ages~     18-45 years, who already use a forefoot strike running gait) in two treadmill running test~     sessions (shod vs barefoot running)~   "
116124|NCT01536158|"~     The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better~     or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.~   "
116125|NCT01536145|"~     This study represents the first-in-human study for CP-751,871. The study aimed to define the~     safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple~     myeloma through a dose escalation design.~   "
116126|NCT01536132|"~     The purpose of this study is to determine the safety and efficacy of intravenous~     administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of~     levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in~     ambulatory patients with advanced chronic heart failure.~   "
116127|NCT01536119|"~     The purpose of this trial is to evaluate the effectiveness of a Coparenting Breastfeeding~     Support Intervention with first time parents on exclusive breastfeeding rates at 12 weeks~     postpartum. Partner support and the coparenting relationship will also be evaluated.~   "
116128|NCT01536106|"~     The primary objective of the study is to determine the feasibility and safety of~     intracoronary administration of autologous bone marrow derived mononuclear cell product in~     patients at risk for clinically significant cardiac dysfunction following AMI.~      The secondary objective of the study is to assess the effect on cardiac function and infarct~     region perfusion. A concurrent placebo control patient group meeting eligibility but not~     receiving autologous bone marrow derived stem cells will be evaluated similar to the treated~     group to assess the rate of significant spontaneous improvement in cardiac function.~   "
116129|NCT01536093|"~     Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory~     protection against nosocomial infection in extremely premature infants. However, most of~     them could not proceed enteral feedings due to clinical instability in the first few days.~     Recent studies supports oropharyngeal administration as a potentially safe and effective~     delivery method for immunologic benefits and only small amount of colostrum could be~     administrated for immune therapy for extremely premature babies. The purpose of this study~     is to determine the beneficial effects of oropharyngeal administration of colostrum for~     immunologic aspects in extremely low gestational age infants and evaluated the safety of~     this method to extremely premature infants in the first few days of life.~   "
116130|NCT01536080|"~     Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final~     diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even~     functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal~     symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the~     measurement of GERD symptoms and response of proton pump inhibitor in short time. Several~     questionnaires have been made for the assessment of GERD symptoms in recent years However,~     their screening tools do not include the impact of symptoms on everyday life and take a long~     time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been~     developed to compensate for this. It is a simple, one-page, questionnaire to communicate to~     the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing~     that it might also prompt clinicians to make appropriate treatment for patients' symptoms.~     However, there was no report regarding comparison of the characteristics and response to PPI~     in RE, NERD and FH groups using GIS questionnaire so far.~   "
116131|NCT01536067|"~     This phase II trial studies how well giving ofatumumab together with bortezomib works in~     treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal~     antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways.~     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help~     kill them or carry cancer-killing substances to them. Giving ofatumumab together with~     bortezomib may be a better way to block cancer growth~   "
116132|NCT01536054|"~     This phase I trial studies the side effects and best dose and schedule of sirolimus when~     given together with vaccine therapy in treating patients with stage II-IV ovarian~     epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made~     from a gene-modified virus may help the body build an effective immune response to kill~     tumor cells. Giving vaccine therapy together with sirolimus may be an effective treatment~     for ovarian, fallopian tube, or primary peritoneal cancer~   "
116133|NCT01536041|"~     The primary objectives of this study are:~      i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo~     on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of~     forced expiratory volume in 1 second (FEV1) after exercise challenge~      ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg~     of ONO-6950 in asthmatic patients.~      The secondary objectives of this study are:~      i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus~     montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise~     challenge~      ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200~     mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.~   "
116137|NCT01535989|"~     This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted~     intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin,~     in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in~     patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both~     Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in~     combination with rituximab in patients with NHLs. This is the first study combining the two~     agents together. In the present study Inotuzumab Ozogamicin will be administered~     intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered~     intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated~     every 28 days.~   "
116138|NCT01535976|"~     Procedures performed under sedation have the same severity in regards to morbidity and~     mortality as procedures performed under general anesthesia1. The demand for anesthesia care~     outside the operating room has increased tremendously and it poses, according to a closed~     claim analysis, major risks to patients . Both closed claim analysis identified respiratory~     depression due to oversedation as the main risk to patients undergoing procedures under~     sedation. The major problem is that hypoventilation is only detected at very late stages in~     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,~     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.~      The incidence of anesthetized patients with obstructive sleep apnea has increased~     substantially over the last years along with the current national obesity epidemic. These~     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The~     context of the massive increase in procedural sedation and the extremely high prevalence of~     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near~     future, increase malpractice claims to anesthesiologists. The development of safer~     anesthesia regimen for sedation are, therefore, needed. The establishment of safer~     anesthetics regimen for sedation is in direct relationship with the anesthesia patient~     safety foundation priorities. It addresses peri-anesthetic safety problems for healthy~     patient's. It can also be broadly applicable and easily implemented into daily clinical~     care.~      Ketamine has an established effect on analgesia but the effects of ketamine on ventilation~     have not been clearly defined. The lack of validated and sensitive instruments to evaluate~     the effects of ketamine on ventilation is an important reason for the conflicting~     results.The investigators have demonstrated that the transcutaneous carbon dioxide monitor~     is accurate in detecting hypoventilation in patients undergoing deep sedation. Animal data~     suggest that when added to propofol in a sedation regimen, ketamine decreased~     hypoventilation when compared to propofol alone. It is unknown if ketamine added to a~     commonly used sedative agent (propofol) can decrease the incidence and severity of~     hypoventilation in patients undergoing deep sedation. It is also unknown if the effect of~     ketamine on ventilation are different in patients with and without obstructive sleep apnea.~      The investigators hypothesized that patients receiving ketamine and propofol will develop~     less intraoperative hypoventilation than patients receiving propofol alone. The~     investigators also hypothesized that this effect will be even greater in patients with~     obstructive sleep apnea than patients without obstructive sleep apnea.~      Significance: Respiratory depression due to oversedation was identified twice as the major~     factor responsible for claims related to anesthesia. The high prevalence of obstructive~     sleep apnea combined with more complex procedures done in outpatient settings can increase~     physical risks to patients and liability cases to anesthesiologists. The main goal of this~     project is to establish the effect of ketamine in preventing respiratory depression to~     patients undergoing procedures under sedation. If the investigators confirm the their~     hypothesis , their findings can be valuable not only to anesthesiologist but also to other~     specialties ( Emergency medicine, gastroenterologists, cardiologists, radiologists) that~     frequently performed procedural sedation. The research questions is;does ketamine prevent~     hypoventilation during deep sedation? The hypotheses is; ketamine will prevent~     hypoventilation during sedation cases.~   "
116139|NCT01535963|"~     The primary objective of this study is to measure the overall level of satisfaction in~     patients after cutaneous surgery in 4 different categories, including the surgeon, facility,~     procedure and recovery and outcome.~   "
116140|NCT01535950|"~     This study will assess the safety and efficacy of LFG316 in patients with age related~     macular degeneration.~   "
116141|NCT01535937|"~     This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the~     time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent~     individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week~     combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.~   "
116142|NCT01535924|"~     This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride~     when given together with gemcitabine hydrochloride and to see how well it works in treating~     patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving more than one drug, combination chemotherapy, may kill more cancer cells.~   "
116143|NCT01535911|"~     This study will look at the effects, good and/or bad, of treating primary brain cancers with~     diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy~     restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal~     while at the same time increasing the blood concentration of metabolic break down products~     called ketones. This diet is currently used to treat children with uncontrollable seizures.~     This diet is well tolerated by the children with minimal side effects reported after using~     the diet for years.~        -  The main purpose of this study is to find out whether or not the energy restricted~          ketogenic diet will help patients with primary brain cancer by either decreasing the~          size of the cancer or by keeping the cancer from growing.~        -  Another reason for doing this study is to learn about the side effects associated with~          the energy restricted ketogenic diet in patients with primary brain cancer.~   "
116144|NCT01535898|"~     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the~     body using magnetic field and radio frequency pulses that can not be felt. The purpose of~     this study is to determine if a new MR imaging method can help tumor evaluation in head and~     neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted~     Magnetic Resonance Imaging which provides image contrast through detection of small~     restrictions in the movement of water molecules. This study may help us provide additional~     information about the tumor along with the picture of the organ.~   "
116145|NCT01535885|"~     This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus~     Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a~     related family member or an unrelated donor. Recipients of these types of transplants are~     severely immune compromised during the early post-transplant period and are more susceptible~     to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T~     Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr~     Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease~     (GVHD) or other infusion related toxicities.~   "
116146|NCT01535872|"~     The aim of this study is to show solid evidences of the efficacy of DHEA in improving the~     success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.~   "
116147|NCT01535859|"~     The purpose of this study is to determine whether cabergoline is effective in reducing the~     incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe~     cases; and to derive biomarkers for the risk of developing OHSS.~   "
116148|NCT01535846|"~     Energy-restricted diets often require dieting rules, which forced the dieter to eat~     according to cognitive norms, which increase his vulnerability to external food cues.~     Allowing the recognition of internal hunger and satiety cues by using conscious food tasting~     could be helpful among restrained eaters to facilitate an internalized regulation of food~     intake.~      The objectives of the proposed study are to investigate among restrained women whether~     conscious food tasting can influence 1) attitudes and behaviors associated with food and~     eating; 2) reliance on hunger and satiety signals; and 3) development of taste and olfactory~     memory.~      Females (n=50) will be randomly assigned to: 1) experimental group (conscious food tasting~     intervention) (n=24), or 2) control group (n=26). The conscious food tasting intervention~     will be conducted by a registered dietitian into groups of ten to twelve women during six~     weekly 2-hour workshops. Women in the control group will not receive any intervention.~     Measurements will be taken at baseline, at the end of the intervention period, and at~     12-week post-intervention. Restraint Scale, Three-Factor Eating Questionnaire, Mindful~     Eating Questionnaire, Intuitive Eating Scale, Body-Esteem Scale and Rosenberg Self-Esteem~     Scale will measure attitudes and behaviors associated with food and eating as well as some~     aspects related to psychological functioning. The Intuitive Eating Scale and a snack-meal~     taste rating task (visual analogue scales) will assess internal hunger/satiety cues.~     Vocabulary used to describe the foods will be recorded from the snack-meal taste rating task~     and use to assess taste and olfactory memory. Sensory capabilities will be assessed by odour~     detection and identification test, and a taste detection test.~      The proposed study will provide a better understanding of the effects of conscious food~     tasting on eating attitudes and behaviors, which is relevant to dietetic practice as it~     could help to promote sustainable healthy eating habits.~   "
116149|NCT01535833|"~     The investigators scientific aims are to determine the benefits associated with the use of~     robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how~     the benefits impact the patient, physician and the institution, and to determine the~     complications associated with the use of the robot. This will be a prospective cohort~     following 100 patients for a 24 month period.~   "
116150|NCT01535820|"~     The purpose of this study is to assess the bioequivalence of the contraceptive hormones of~     ORTHO EVRA when the patch is applied with and without an adhesive overlay.~   "
116162|NCT01535664|"~     The purpose of this study is to determine changes on overall gait as well as in multiple~     gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are~     receiving the medication consistently for at least two weeks prior to screening.~   "
116151|NCT01535807|"~     The objective of this study is to identify proteomic inflammatory biomarkers to determine if~     there are differences in the biomarkers in patients who are treated using the CorMatrix ECM~     implant to close the pericardium and the patients whose pericardium is left open (the~     current standard of care).~   "
116152|NCT01535794|"~     The FDA has recently approved Gardasil for the prevention of anal cancer in people aged~     9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and~     could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and~     little is known about factors associated with vaccine acceptance in this population. With~     the risk of anal cancer among MSM higher than the risk of cervical cancer among women before~     routine cytological screening was introduced, acceptance of a prophylactic vaccine in this~     subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence~     of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine~     has many acceptable concepts among these men, there are multiple barriers which may~     potentially interfere with their likelihood of initiating the vaccine series. Vaccine~     catch-up rates among women of a similar age has been poor, and there is no reason to expect~     this to be higher among men. One potential strategy to increase vaccine uptake in this~     catch-up group is to implement a patient-driven program to promote vaccination among men.~      This project will contribute to the investigators understanding of how the investigators can~     utilize social networks to identify barriers to HPV vaccination among YMSM, and how to~     potentially influence a patient-driven vaccination effort to increase uptake among men in~     the catch-up age group. This research will inform future interventions to targeted~     populations that may be incorporated into online social networking websites to encourage HPV~     vaccination.~   "
116153|NCT01535781|"~     The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with~     pertrochanteric hip fractures.~      Tranexamic acid is a well known drug used in many types of surgery. The investigators wish~     to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood~     loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric~     hip fracture.~      An interim analysis was planned when reaching 60 inclusions. The interim analysis was~     conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was~     considered a reason to halt the study. The 0.001 level was chosen as a simple approach to~     this interim analysis from the Haybittle-Peto boundary~   "
116154|NCT01535768|"~     After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation~     phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months~     postoperatively. When this does occur, it is treated with aqueous suppressant eye drops.~      This study aims to determine if it is possible to reduce the rate of hyperencapsulation~     phase. Patients in the treatment group will receive aqueous suppressant eye drops before the~     hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure~     is above a pre-defined level, and will target a pre-defined range.~   "
116155|NCT01535755|"~     The investigators use a protocol to wean from noninvasive mechanical ventilation.~   "
116156|NCT01535742|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate~     through the Ambu Aura-i or air-Q ILA.~   "
116157|NCT01535729|"~     This prospective observational study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after~     failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in~     routine clinical practice will be collected for 1 year.~   "
116158|NCT01535716|"~     Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the~     medical care during anesthesia.According to medical literature, goal-directed fluid and~     hemodynamic optimizations are more efficient when based on the dynamic parameters than when~     based on the statics ones, and the major dynamic criteria is the cardiac output.~     Unfortunately, transpulmonary thermodilution, the device considered as The gold standard~     to evaluate cardiac output is associated with many complications.Furthermore, devices~     commercialized in the past decade were not able to replace the transpulmonary~     thermodilution.~      As all monitoring devices aren't reliable enough to be widely used in practice they are left~     aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on~     the analysis of several clinical parameters seems to guarantee good cares thanks to a~     favorable benefits/risks balance, it could be improved by new plug and play mini-invasive~     systems.~      In the investigators opinion, the ECOM system seems able to provide a monitoring tool which~     responds to all the expectations of a modern hemodynamic monitoring device. It uses a well~     known technique, the bioimpedance. The investigators suppose this device should be more~     efficient than the one that has been used before. Indeed, as the system is build on the~     endotracheal tube, it comes closer to the aorta, where all the measures are made, and the~     recorded signal should be less affected by the passage through the surrounding tissues.~      This randomized and controlled trial will study Patients scheduled for elective coronary~     surgery with cardiopulmonary bypass.~      The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed~     hemodynamic therapy based on the ECOM cardiac output measure on mortality and major~     postoperative cardiac morbidity after coronary surgery, when compared with a standard~     management strategy.~      Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard~     management strategy, applied to the control group, will be set and led by the attending~     anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face~     the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and~     stroke volume variation.~      The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure~     will reduce mortality and morbidity after cardiac surgery.~   "
116159|NCT01535703|"~     Monitoring could secure management for patient but stay invasive. The purpose of this study~     was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary~     thermodilution(reference method) and digital photoplethysmography (non invasive) for~     absolute value and dynamics changes before and after fluid expansion for patients with~     indication of fluid challenge.~   "
116160|NCT01535690|"~     Background: Photodynamic therapy (PDT) is a method of microbial reduction which can benefit~     periodontal treatment in areas of difficult access, such as deep pockets and furcations. The~     aim of this randomized controlled clinical trial was to evaluate the effects of PDT as an~     adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic~     periodontitis.~      Methods: Twenty-two patients with at least one pocket with probing depth (PD) ≥ 7 mm and one~     pocket with PD ≥ 5 mm and bleeding on probing (BOP) on each side of the mouth were included,~     characterizing a split mouth design. The control group underwent full-mouth ultrasonic~     debridement and test group received the same treatment associated with PDT. The following~     clinical parameters were evaluated: plaque index, gingival index, BOP, gingival recession~     (GR), PD, and clinical attachment level (CAL). All parameters were collected before, 1, 3~     and 6 months after treatment.~   "
116161|NCT01535677|"~     This is an open-label, randomised study to compare the similarity of a combination~     Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and~     fed conditions in healthy volunteers.~   "
116164|NCT01535638|"~     The primary objective of the current study is to investigate the relative bioavailability of~     three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation~     (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets~     and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy~     volunteers, with the aim to compare the bioavailability of the three formulations. All~     treatments will be applied fed, 30 minutes after start of the intake of a standard normal~     breakfast.~   "
116165|NCT01535625|"~     This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system~     for the treatment of single de novo lesions in a native coronary artery. The stent is coated~     with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to~     increase the resistance towards corrosion and to significantly improve endothelialisation~     through the inhibition of elution of metallic ions.~   "
116166|NCT01535612|"~     The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes~     (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple~     patch on insulin delivery device) to control his/her blood glucose.~   "
116167|NCT01535599|"~     The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic~     Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for~     the treatment of acute otitis externa (AOE).~   "
116168|NCT01535586|"~     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder~     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in~     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and~     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment~     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the~     general population. The proposed study aims at comparing the efficacy, tolerability, and~     adherence of mandibular advancing devices-an alternative therapy to OSA- to CPAP. The study~     is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA~     phenotype that would predict MAD response.~   "
116169|NCT01535573|"~     This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine~     dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent~     patients will be assigned equally to one of three medication conditions: placebo or the~     Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or~     40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase~     periods of sustained abstinence substantially more than placebo. Performance on a set of~     behavioral tasks of impulsivity will be analyzed as potential predictors of treatment~     response.~   "
116170|NCT01535560|"~     The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle~     based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa~     (AOE).~   "
116171|NCT01535547|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of tacrolimus after single dose administration.~   "
116172|NCT01535534|"~     During the past years many investigators have focused on the immunological changes in sepsis~     disease, and great attention has been paid to the development of practicable means of~     immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during~     the time course of patients with sepsis.~   "
116173|NCT01535521|"~     The investigators will perform a clinical trial comparing mandibular advancement device~     (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in~     patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive~     polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD.~     PSGs are performed at the Antwerp University Hospital.~   "
116174|NCT01535508|"~     Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation,~     titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in~     vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.~      The study will determine if initial safety and effect estimates predict that a double blind~     randomized control trial (RCT) with a larger set of patients will be worthwhile in the~     localization of this treatment aimed at improving the symptoms of ASDs.~      Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core~     symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior,~     and sleep, as determined by parental and clinical evaluation scales.~   "
116175|NCT01535495|"~     This study is investigating if the oral beta antagonist propranolol can induce regression of~     retinal neovascularization associated with proliferative diabetic retinopathy.~   "
116176|NCT01535482|"~     The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT)~     with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of~     suicide ideation (SI) and the severity of depression and hopelessness among older men. The~     investigators expect that suicidal older men randomly assigned to the CT intervention~     condition will have a lower rate of SI during the follow-up period than participants~     assigned to the control condition.~   "
116177|NCT01535469|"~     This will be a stepped wedge randomized trial design to evaluate the implementation of~     cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected~     persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are~     ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral~     flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose~     fluconazole. After 6 months survival with retention-in-care will be compared between those~     who are CRAG+ and CRAG negative~   "
116178|NCT01535456|"~     The main purpose of this study is to see if this tracer can be used to determine how well~     chemotherapy is working in patients with certain types of leukemia.~   "
116179|NCT01535443|"~     Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in~     healthy volunteers.~   "
116191|NCT01535287|"~     The investigators are inviting your child to participate in this research study because your~     child is having myringotomy (putting a tiny incision in the eardrum with or without tube~     insertion) under general anesthesia.~      The purpose of this study is to determine whether a single injection of Dexmedetomidine~     (study medication) decreases the frequency of awaking from anesthesia frightened or agitated~     in children having myringotomy surgery as compared to those children who receive placebo~     (sterile saltwater).~   "
116180|NCT01535430|"~     Purpose of the study:~      AIM 1 Prospectively collect pre-operative (fMRI, DTI, MEG) and intra-operative mapping data~     in patients with intra-axial brain tumors to assess how well each modality predicts the~     location of eloquent brain function. In addition, each modality will be compared with the~     other.~      AIM 2 Assess reorganization of eloquent brain function and plasticity in patients with~     intra-axial brain tumors. This will be accomplished by prospectively collecting~     post-operative mapping studies and neuropsychological tests to compare them to prior mapping~     studies as stated above.~   "
116181|NCT01535417|"~     The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a~     new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.~   "
116182|NCT01535404|"~     The purpose of this study is to compare chronic (1-year) effects on left ventricular~     ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA)~     versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left~     ventricular systolic function (>= 45%).~   "
116183|NCT01535391|"~     This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally~     twice daily for 24 months and indefinitely if it is in the interest of the patient.~      The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice~     daily with dose increase to 400 mg twice daily in case of suboptimal response or failure~     (excluding patients who will fail for progression to ABP), in a population of patients with~     Ph-positive, BCR-ABL positive CML in early CP.~   "
116184|NCT01535378|"~     If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more~     and more important. Treatment of patients presenting TMD is based on conservative and~     reversible therapeutics. The behavioural reeducation of these patients which aims at~     decreasing their parafunctions is a treatment often performed.~   "
116185|NCT01535365|"~     Muscle sprains of the back and neck are very common. In addition to pain and~     antiinflammatory medications the use of either cold or hot packs has been recommended. In~     the current study we will compare ice packs and heat packs to see which is more effective at~     relieving pain from back and neck sprains while in the Emergency Department.~   "
116186|NCT01535352|"~     Low income mothers of young children represent a disadvantaged group who are at exceptional~     risk for depressive syndromes and who have increasingly limited access to mental health~     services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated~     cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with~     Depression Course, and tailored to mothers of young children. Mom-Net, which was developed~     and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to~     overcome the substantial barriers to treatment participation that exist for mothers~     experiencing economic hardship and those in rural communities. Though the pilot trial~     demonstrated that the program was very effective in reducing depressive symptoms and related~     difficulties, it was conducted under the 'idealized' conditions typical of initial~     intervention tests (e.g., computers and internet connections were supplied to all~     participants; access to the internet was provided by a single browser; coaches who provided~     weekly phone support were research staff, and initial recruitment and motivational~     interviews sessions were conducted via home visits to participants). These conditions likely~     facilitated recruitment and retention of participants, as well as ease and fidelity of~     treatment delivery. Thus one goal of the current project is to evaluate the intervention~     under conditions that are closer to those of real-world service providers and recipients.~     The current project is also intended to provide a more rigorous test of the intervention~     than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers~     of 3-5 year old children recruited through Head Start classrooms and prescreened for the~     presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment,~     participants will be randomized to either the intervention or facilitated usual care (FUC)~     condition. The evaluation of the intervention will focus on maternal depressive symptoms,~     parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and~     24-month intervals) will enable us to examine maintenance of effects. Overall, the~     investigation will contribute to the evidentiary base regarding the dissemination potential~     of this empirically-supported intervention, adaptations to which have the potential to~     enable a greater proportion of the population to access and benefit from it.~   "
116187|NCT01535339|"~     Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport.~     Despite ongoing research, there is no highly sensitive clinical test for cognitive function.~     This makes the clinical diagnosis of concussion particularly difficult as the clinical~     presentation of concussion is highly variable with symptoms often evolving over time. Given~     the variability in concussion presentations, there is no single test that can diagnose a~     concussion. Current recommendations are that sports medicine providers apply a multifaceted~     concussion assessment battery that combines subjective symptoms, motor control and cognitive~     assessment.~      This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in~     detecting and managing concussive injuries. This study will establish the reliability of~     BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC~     and sub-concussive head impacts on BNA scores.~   "
116188|NCT01535326|"~     In minimally sedated Asian patients in a community setting the investigators showed that a~     limited volume of water infusion instead of air insufflation in either the rectal sigmoid~     colon or the whole colon significantly reduced pain score during colonoscopy. Cecal~     intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in~     our previous studies.1, 2 In contrast, several US reports described the successful use~     larger volumes of water infused throughout the entire colon in patients undergoing~     colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A~     recent review suggested that the cause of the difference might lies in the timing of water~     removal.6 Specifically, the investigators group removed the infused water predominantly~     during withdrawal phase (water immersion) and the U.S. group removed water during insertion~     phase (water exchange).~      This prospective, randomized controlled trial compared water exchange or water immersion~     with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The~     investigators test the hypothesis that water exchange can reduce more pain than water~     immersion in the investigators clinical setting.~   "
116189|NCT01535313|"~     Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness~     is improved with a powered bone marrow biopsy device in comparison with a manual device.~   "
116190|NCT01535300|"~     The aim of the present study was to evaluate the role of ultrasound in paediatric patients~     to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal~     transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by~     different age-related formulas.~      The investigators hypothesize that a prediction of pediatric ETT is possible with the~     ultrasonographic measurement of the MTTD.~   "
116202|NCT01535144|"~     The purpose of the study is to show the equivalence of a new degradable metallic device to a~     non-degradable metallic device in patients with Hallux Valgus.~   "
116192|NCT01535274|"~     The seated or beach chair position during surgery and general anesthesia decreases brain~     oxygen levels and can result in stroke. As such, poor neurological outcome following beach~     chair positioning is a growing concern. In the proposed study the investigators test the~     hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral~     oxygenation in anesthetized patients in the beach chair position.~   "
116193|NCT01535261|"~     The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using~     as needed (PRN) dosing over 24 months in patients with visual impairment due to macular~     edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition~     optical coherence tomography (OCT) images was analyzed to gain insights into predictive~     factors for disease progression and the possibility of reduced monitoring was assessed in~     Year 2. The results of this open-label study provided long-term safety and efficacy data to~     further guide recommendations on the use of ranibizumab in this indication.~   "
116194|NCT01535248|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize~     and evaluate the pancreatic and biliary systems. It has been reported that rare instances of~     air embolus have been found associated with the performance of an ERCP and many of these~     events are fatal. It is our proposal to use transthoracic echocardiography to continuously~     evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and~     attempt to quantify the incidence of this complication and any potential patient factors~     that might increase the risk of this complication.~   "
116195|NCT01535235|"~     The investigators propose a proof-of-concept, pathogenesis-oriented, randomized,~     placebo-controlled pilot study to assess whether the addition of an angiotensin converting~     enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses~     lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune~     responses and an accelerated clearance of the latent reservoir.~   "
116196|NCT01535222|"~     The purpose of this study is to demonstrate that periprocedural infusion of escalating doses~     of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to~     characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of~     MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and~     to investigate the effect on exploratory clinical endpoints of bleeding, transfusion~     requirements and reexploration.~   "
116197|NCT01535209|"~     Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is~     considered as a standard associated with side effects leading to decreased neurocognitive~     function. The Investigators addressed the question whether stereotactic radiotherapy of the~     resection cavity impairs neurological status and/or cognitive functions in compare to~     adjuvant WBRT.~   "
116198|NCT01535196|"~     The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin~     substitution improve the heart function in chronic heart failure.~      Type of study: Controlled, randomized, double blind, placebo control~      Number of patient: 300; 150 treated and 150 placebo controlled~      Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month~      Duration of study:1+1 year~      Primary end points:~      Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,~      Secondary end points:~      Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant~     in 6 minutes~      Visits:~      Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,~   "
116199|NCT01535183|"~     The outcome of pediatric refractory or relapsed brain tumor is very dismal. Standard~     chemotherapy showed poor response to these patients. Although tandem high dose chemotherapy~     with hematopoietic progenitor stem cell rescues has been chosen as a potentially curative~     therapy for long term survival and better outcome is expected if tumor burden before~     transplantation reduced by chemotherapy, effective salvage chemotherapy for tumor reduction~     is not established yet. Irinotecan is a recently developed topoisomerase I inhibitor, and~     there are preclinical and phase I, II data which proved practical effects in brain tumors.~     In those studies, irinotecan was administered alone or in combination with one other drug.~      Vincristine, etoposide, carboplatin, and cyclophosphamide have been used in many protocols~     for brain tumors but the result was very poor in refractory or relapsed cases. However,~     irinotecan can be effective with these multiple chemotherapeutic agents. According to the~     pilot study of irinotecan in combination with vincristine, etoposide, carboplatin and~     cyclophosphamide in the investigators center, 75% percent of total 12 patients reached more~     than stable disease, and 2 patients got long term complete remission only with this~     multi-agent combination chemotherapy. But the combination of irinotecan, vincristine,~     etoposide, carboplatin, and cyclophosphamide is not clinically studied yet especially for~     pediatric patients. To improve response rate and progression-free survival, the combination~     chemotherapy of irinotecan, vincristine, etoposide, carboplatin, and cyclophosphamide is~     designed for pediatric refractory or relapsed brain tumor.~   "
116200|NCT01535170|"~     Nosocomial infection with antibiotic-resistant strains is a major threat to critical care~     medicine. Selective decontamination of the digestive tract (SDD) is one of the strategies to~     reduce ventilator associated pneumonia and sepsis in critically ill patients. Lactoferrin~     (LF) is a natural multifunctional protein with antimicrobial, anti-tumor, antioxidant, and~     immunomodulatory effects. It has been shown to inhibit the growth of a number of pathogenic~     bacteria including antibiotic-resistant strains, fungi and even viruses in both in vitro and~     in vivo studies.~      In a recent study, the investigators performed pathogen challenges of the digestive tract of~     a transgenic milk-fed animal model. The results showed that recombinant LF has broad~     spectrum antimicrobial activity in the digestive tract and protects the mucosa of the small~     intestine from injury, implying that LF can be used as an effective selective decontaminant~     of the digestive tract.~      This study is a prospective, randomized, double-blind, placebo- controlled clinical trial~     examining whether oral supplementation with bLF can reduce nosocomial infection, sepsis and~     even mortality in patients with prolonged mechanical ventilation (MV). Patients with MV for~     more than 21 days and no signs of infection on admission to our Respiratory Care Center~     (RCC) will be enrolled. They will be randomized to receive either bovine LF (bLF, 10~     mg/kg/day) or placebo for 6 weeks by center.~      The primary objective is to evaluate the effectiveness of bLF in the prevention of~     nosocomial infection. Secondary objectives are assessment of incidence of nosocomial~     infection, mortality, weaning rate from MV and change of the immune system. The~     investigators hypothesize that bLF may 1) prevent nosocomial infection; 2) reduce mortality;~     3)increase weaning rate from MV; 4)increase immunity in patients with prolonged MV.~   "
116201|NCT01535157|"~     The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus~     ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma.~     In addition, researchers would like to determine if the drugs are most effective together or~     if fenretinide (4-HPR/LXS) is most effective alone.~   "
116203|NCT01535131|"~     This study compares a standard method for palate repair (the Furlow palatoplasty) with a~     modification of that method to determine which, if either, is more effective in reducing the~     duration of middle-ear disease (fluid in the ear) in cleft palate patients.~   "
116204|NCT01535118|"~     This study will gather information on allergic rhinoconjunctivitis from surveys completed by~     adults and children.~   "
116205|NCT01535105|"~     Obesity is increasing all over the world in adults, adolescents and children,and is followed~     by morbidity, including the metabolic syndrome.~      Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis~      The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18~     years, among high risk diabetes prone population, for diagnosis and treatment.~   "
116206|NCT01535092|"~     Orthotopic liver transplantation (OLT) is the treatment of choice for patients with~     Hepatitis C Virus (HCV) infection and end-stage liver disease or hepatocellular carcinoma;~     infection of the graft and hepatitis C recurrence is universal after OLT and recurrent HCV~     hepatitis often follows an accelerated course after OLT, with rapid histological recurrence~     and cirrhosis. These very poor outcome significantly affect graft and patient survival and~     reduces the benefit of transplantation for this indication. Therapeutic strategies are not~     available; high viral load, high prevalence of genotype 1b and need of dose reduction of~     interferon and ribavirin because of the side effects or intolerance, together with the~     interference of immunosuppressive drugs, resulted in the vast majority of the patients in~     failure in obtaining viral eradication.~      Recently, Silibinin, has been studied and reported to be capable to act as potent antiviral~     agent in patients with HCV; it has been used successfully in a protocol of a 14 day~     intravenous infusion in previous non-responders to peginterferon/ribavirin therapy. In view~     of his postulated profile of safety, it seems an ideal drug to be used in the setting of HCV~     recurrent patients after liver transplant.~      Aim of this prospective, randomized, double-blind, placebo-controlled, parallel group study~     is to determine the therapeutic effect of Legalon SIL in the prevention of HCV reinfection~     in chronically infected hepatitis C patients after OLT.~      Awaiting orthotopic liver transplantation patients affected by HCV will be randomised 3:1 to~     receive, in addition to their current therapy, silibinin 20mg/kg/day (Legalon SIL) or~     placebo infused over 2 hours from 14 to 21 consecutive days; in addition, patients will~     receive treatment with silibinin 20mg/kg/day (Legalon SIL), infused over 2 hours, for 7 days~     after transplant.~      The Primary Efficacy endpoint is to achieve sustained virological response (SVR) while~     Secondary Efficacy endpoints are to evaluate the virologic response, the percentage of~     patients who has a decreased of at least 2 log10 the levels of HCV-RNA and the safety of~     Legalon SIL in this population.~   "
116207|NCT01535079|"~     Sore throat is one of the most common complaints encountered in clinical practice. And in~     65% of cases, the infection is thought to be viral in nature.~      The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after~     single administration in acute sore throat pain.~   "
116208|NCT01535066|"~     RATIONALE: Acupuncture may help relieve joint pain.~      PURPOSE: This randomized phase III trial studies acupuncture to see how well it works~     compared to sham acupuncture or waitlist in treating patients with joint pain related to~     aromatase inhibitors in patients with early-stage breast cancer.~   "
116209|NCT01535053|"~     This randomized phase III trial studies how well methotrexate works compared to dactinomycin~     in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in~     chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether methotrexate is more effective~     than dactinomycin in treating gestational trophoblastic disease.~   "
116210|NCT01535040|"~     RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms~     of nicotine withdrawal.~      PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride~     works compared to placebo in helping cancer survivors stop smoking.~   "
116211|NCT01535027|"~     Increased bone formation in the absence of accelerated resorption is resulting in a marked~     anabolic response to teriparatide (TPTD) during the early phase after treatment initiation.~     Months later, due to coupling mechanism, the sustained increase of bone formation and~     ongoing anabolic effects are accompanied by significantly increased bone resorption as well.~     Antiresorptives influence the balance of bone formation and resorption. Therefore the~     investigators aim is to investigate the effects of the addition of antiresorptives to the~     second half of TPTD cycle when resorption is already also markedly elevated.~   "
116212|NCT01535014|"~     The purpose of this study is:~        -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in~          treatment of obese patients.~        -  To assess clinical efficiency of Dietressa in the dose of 6 tablets daily within 24~          weeks of therapy in reducing body weight in obese patients.~        -  To compare clinical efficiency of two dosage patterns for Dietressa (1 tablet 6 times~          daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.~   "
116213|NCT01535001|"~     The purpose of this study is to test whether an algorithm for systematic non-surgical~     treatment consisting of corrective insoles, neuromuscular training, weight loss, patient~     education and pharmacological treatment with paracetamol, non steroidal anti inflammatory~     drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality~     of life than standard non-surgical treatment (information on the disease and how to treat~     it) in patients with knee osteoarthritis.~      The H1-hypothesis is that the treatment algorithm results in a greater increase in quality~     of life and functional capacity and greater reduction in pain than standard treatment at the~     primary endpoint, which is follow-up 12months after the start of the treatment.~      See statistical analysis plan available under Links for further description of the study.~   "
116224|NCT01534845|"~     1. The management of anaplastic gliomas of WHO grade 3 is currently largely based on~          surgery followed by radiotherapy, of which prognosis remains still dismal with the~          median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is~          unclear of modest at best with conventional cytotoxic agents, and the role of~          temozolomide for these entities still is not elucidated.~        2. Codeletion of chromosome 1p/19q is considered the most important marker of prognostic~          significance in WHO grade 3 gliomas.~        3. To project a randomized phase 2 screening trial examining the efficacy of concurrent~          chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3~          gliomas without codeletion of chromosome 1p/19q.~        4. The prognostic significance of methylation status of MGMT and IDH1 mutation as~          molecular markers will be also assessed in each arm as key secondary analysis.~   "
116225|NCT01534832|"~     The study will examine the safety and performance of a new surgical smoke clearance system~     designed for use during laparoscopic surgery.~   "
116710|NCT01528384|"~     This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients~     who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior~     treatments. The study hypothesis is that this drug will be safe in pediatric patients.~   "
116214|NCT01534975|"~     The purpose of this study is to compare the effects of a certain contrast agent (iodixanol)~     to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol~     (Omnipaque), on heart and kidney safety in patients undergoing a cardiac CT angiogram. The~     investigators will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is~     better tolerated (flushing, injection site pain/warmth, headache, nausea) and provides equal~     image quality compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice~     multidetector computed tomography angiography (MDCTA). A fourth group (Visipaque 270) will~     be included, using low radiation dose technology during acquisition, to evaluate image~     quality, tolerability, and contrast enhancement compared to both Visipaque 320 and Omnipaque~     and Isovue. In addition to image quality, tolerability, and contrast enhancement, the~     investigators will evaluate heart rate, adverse events, reimaging, costs, and patient~     satisfaction among all four cohorts.~      The study will recruit 400 participants already undergoing CT angiography and consent and~     randomize them to one of four groups. Each of the possible contrast agents used are commonly~     used for CT angiography, so the primary risk is loss of confidentiality and being asked~     questions about tolerability. All other facets of the study (3 lead ECG, beta blockade,~     nitroglycerine use, CT angiography and contrast administration) are standard of care and~     being done for clinical uses.~   "
116215|NCT01534962|"~     Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low,~     intermediate and high, given BID) versus placebo in maintaining sinus rhythm after~     successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).~      After successful cardioversion and subsequent randomisation, patients report~     trans-telephonic EGCs on a daily basis to a central core ECG facility.~      Maximum treatment duration is 112 days (16 weeks).~   "
116216|NCT01534949|"~     This study is designed to provide initial evidence of safety, pharmacokinetics,~     pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.~   "
116217|NCT01534936|"~     This is a noninterventional observational study lead amongst psychiatrists, to assess the~     the overall status of schizophrenic outpatients with affective symptoms treated with~     atypical antipsychotics.~   "
116218|NCT01534923|"~     The purpose of this study is to learn more about doctor-patient communication about colon~     cancer screening. This study will also look to see if there are differences in those who get~     colon cancer screening based on the discussion the doctor had with the patient.~   "
116219|NCT01534910|"~     The investigators will be assessing the effect of Aged Garlic Extract on the coronary~     arteries. The investigators will enroll patients in a double blind study, where half the~     patients will receive placebo, and have the patients undergo a series of tests of plaque (CT~     scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and~     then repeat the tests and blood work at the end of one year. The investigators will assess~     if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries.~     The investigators will also assess the effect of aged garlic extract on markers of~     inflammation. Patients will receive free drug, free testing and be compensated, and learn~     more about their heart and neck arteries. if successful, more patients can use this drug to~     benefit their health. The harms include the radiation from the CT scan and the medication,~     which has mild side effects.~   "
116220|NCT01534897|"~     Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid~     Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no~     longer respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence~     suggest that blocking the BRAF gene may help to re-sensitize the tumors to radioactive~     iodine. BRAF is a protein that plays a central role in the growth and survival of cancer~     cells in some types of PTC. The investigational drug GSK2118436 may work by blocking the~     BRAF protein in cancer cells lines and tumors that have a mutated BRAF gene.~      In this research study, the investigators are looking to see if GSK2118436 can re-sensitize~     iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at~     the safety of adding GSK2118436 to radioactive iodine therapy.~   "
116221|NCT01534884|"~     This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective,~     Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last~     and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA~     concomitantly treated with MTX during the Core Study Period.~   "
116222|NCT01534871|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects approximately 1% of~     all Canadians. RA is associated with a higher rate of disease and death as well as a~     decreased life expectancy. Changes in death rates and life expectancy are mainly the result~     of an increased frequency of cardiovascular disease (CVD). The increase in CVD frequency is~     primarily attributable to accelerated atherosclerosis. It is believed that elevated levels~     of inflammation, which are characteristic of RA, play a key role in accelerated rate of CVD~     in RA patients. Thus, inflammation is considered a primary risk factor for CVD in RA~     patients. Interestingly, despite a better understanding of the relationship between RA and~     CVD and improved treatment for RA patients the death rate in RA population continues to~     increase. Thus, there is an immediate need to develop treatment strategies to reduce the~     risk of CVD associated with inflammation in the RA population.~      Exercise is commonly used to reduce the risk of CVD. Preventative exercise programs are~     often offered as part of cardiac rehabilitation (CR) programs. These programs help patients~     modify CVD risk factors, improve physical capacity and decrease CVD risk. Studies also~     suggest that CR programs decrease levels of inflammation. Since RA patients have an elevated~     risk for CVD, which is primarily attributed to increased levels of inflammation, they are~     prime candidates for CR programs. However, RA patients are very rarely referred to CR~     programs. Thus, there is a lack of information regarding the effects of CR on RA patients.~     Thus studies are needed to determine whether CR modifies levels of inflammation and~     decreases CVD risk in RA patients. Therefore, the purpose of this study is to determine the~     effects of a 12-week standardized cardiac rehabilitation exercise program on systemic~     inflammation and CVD risk in individuals with RA. Specifically, this study will characterize~     the effects of a community based CR exercise program on systemic markers of inflammation~     (proinflammatory cytokines) and global CVD risk (Framingham risk profile) as well as the~     therapeutic effects of CR exercise on the severity of RA.~      This study will help to clarify the mechanism(s) by which exercise impacts CVD risk in~     patients with inflammatory disease. In addition, the study will show how CR may benefit~     patients with inflammatory disease with respect to their ability to exercise, global risk~     for cardiovascular disease and quality of life.~   "
116223|NCT01534858|"~     The purpose of this study is to evaluate the healing of split thickness skin grafts when~     treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.~   "
116258|NCT01534377|"~     This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A)~     for the treatment of depression and prevention of depression in maltreated and nonmaltreated~     girls between the ages of 13-15 years old.~   "
116263|NCT01534312|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has~     proven safe and with no influence on dietary intake. We hypothesize that orally administered~     CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative~     colitis.~   "
116226|NCT01534819|"~     Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX~     EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be~     divided, as appropriate, into two groups.~        1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA~          where the investigator believes the proximal aortic neck is challenging such that the~          risk of failure or fixation and/or sealing is great enough so that the use of the~          Heli-FX EndoAnchor System is warranted.~        2. Revision Group- Those subjects who have previously undergone an EVAR procedure where~          the investigator believes that use of the Heli-FX EndoAnchor System is warranted to A-~          Treat existing graft migration and/or type 1a endoleak, with or without the concurrent~          use of other devices. B- Treat subjects believed to be at risk for migration and/or~          Type 1a endoleak~      Subjects must sign an ICF prior to obtaining any study specific information. Subjects are~     eligible to be consented up to 30 days post-procedure.~      Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post~     procedure. Study recommended follow-up is per SVS and ESVS guidance.~   "
116227|NCT01534806|"~     The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in~     combination lead in a larger reduction in pain score compared to prochlorperazine alone when~     treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this~     combination of medications treats not only the pain but also the associated gastrointestinal~     symptoms of migraine. The main outcome of this study is the reduction in the patient's pain~     score at 60 minutes from administration of the study medications. Secondary outcomes include~     the number of patients achieving complete resolution of the headache while in the ED, the~     number of patients requiring additional treatment interventions by the treating physician,~     the number of patients with resolution of the associated symptoms like nausea, vomiting,~     photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge,~     and side effects of the medications.~   "
116228|NCT01534793|"~     This observational study aims at describing the learning curve of the Holmium Enucleation of~     the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.~   "
116229|NCT01534780|"~     Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7~     cm, laparoscopic surgery with intraperitoneal onlay mesh.~      Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated~     with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the~     2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions~     at 1, 6, 12, 24, 36, 48 and 60 months postoperative.~   "
116230|NCT01534754|"~     This is a multi-centre, randomised, double blind, double-dummy, parallel groups,~     placebo-controlled trial was conducted in a population of patients suffering from~     symptomatic uncomplicated diverticular disease in order to investigate which is the best~     treatment in preventing relapses of the disease.~      Patients were randomly divided in double-blind fashion in one of the following groups:~      Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei~     placebo, 1 sachet/day for 10 days/month;~      Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800~     placebo, 2 tablets/day for 10 days/month;~      Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1~     sachet/day for 10 days/month;~      Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1~     sachet/day for 10 days/month.~      The main objective was to assess the safety and the efficacy of mesalazine and/or~     Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular~     disease~   "
116231|NCT01534741|"~     Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied~     Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic~     hemodialysis patients Treatment: Each patient will be treated by post-dilution online~     hemodiafiltration once with each dialyzer type.~      Study objectives: Intraindividual comparison of removal rate of urea, phosphate,~     ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and~     alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during~     post-dilution online hemodiafiltration.~      Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea,~     phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and~     alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects~   "
116232|NCT01534728|"~     Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of~     the global population. Contrary to other chronic infections such as HIV, clearance of HCV is~     possible. While much is now known about the response to treatment in chronic HCV patients,~     the fact that acute HCV infection is typically asymptomatic (~80% of patients show no~     clinical signs) has made it challenging to define the mechanisms involved in spontaneous~     clearance.~      Immune protection against HCV is thought to be largely dependent upon the CD8 T cell~     response. Therefore using the latest T cell detection technology the investigators will~     develop a panel of tetramers specific for all potential HCV epitopes. To produce the~     tetramers the investigators will utilize HLA ligand exchange technology which allows the~     production of very large collections of peptide-HLA multimers for T cell staining. The~     investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T~     cell epitopes using published viral sequences and algorithm prediction databases. Using this~     information the investigators are currently in the process of developing collections of~     peptide-HLA multimers for T cell staining. Therefore the investigators require large~     lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each~     tetramer on the CD3+CD8+ T cells.~      The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be~     able to test and compare the frequency of possible conserved epitopes present in both HCVg1~     and HCVg4 infections. Once developed this technique will allow us to examine all~     virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller~     quantities of blood. The development of these technologies will also allow us to tailor such~     future diagnostic tests to local populations where a viral subspecies is prevalent; for~     example using North-African HLA alleles for HCVg4 epitopes.~      The work carried out using such assays will provide important immunological correlates of~     viral clearance that will impact vaccine design for HCV infections. Finally, the~     identification of protective CD8 T cells specific for HCV may allow new diagnostic tools~     with predictive powers of disease progression that can be used on any flow cytometer~     machine.~   "
116233|NCT01534715|"~     The purpose of this study is to test the safety and tolerability of IMGN529 in patients with~     relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).~   "
116259|NCT01534364|"~     The aim of this study is to assess the effect of a diet prior to cardiac surgery on the~     common postoperative decline of renal function. Until now, there is no known drug or~     procedure to preserve the kidneys from this impairment. Patients with a known kidney disease~     are especially at risk. A potential beneficial effect of a diet prior to surgery has been~     shown in investigations in mammals, therefore this study will investigate if a preoperative~     diet in patients with known kidney disease and scheduled heart surgery can attenuate or~     prevent a postoperative loss of kidney function.~   "
116234|NCT01534702|"~     With current chemotherapy protocols, in 60-80% of patients with acute myeloid leukemia (AML)~     the leukemic blasts in the bone marrow can be reduced to < 5%. This is called complete~     remission (CR) and is the prerequisite for cure of the disease. During the last years,~     several genetic and biologic risk factors for the achievement of CR have been defined, and~     the remission rates vary considerably between patient groups with different risk profiles.~     On one hand, patients with certain chromosomal or molecular aberrations have very high CR~     rates of approximately 90%. Moreover, in some of these patients, molecularly targeted~     therapies for specific genetic aberrations are currently evaluated in clinical trials.~     However, these genetic aberrations account for only 50-60% of the overall patient population~     in AML. The remaining patients have a significantly inferior CR rate of only 50-60% with 30%~     resistant disease after two cycles of standard induction chemotherapy. In conclusion, there~     is need for improved induction regimens in a large number of adult patients with AML. An~     improved CR rate in this patient population will increase the number of patients eligible~     for intensive consolidation such as an allogeneic stem cell transplantation and might~     thereby be the basis for a better overall outcome. However, there is no clear evidence that~     this goal can be achieved with the currently available chemotherapy protocols. Clofarabine~     (2-chloro-2-fluoro-deoxy-9-D-arabinofuranosyladenine) is a nucleoside analogon which~     combines properties of fludarabine and cladribine. Due to the lack of neurological side~     effects, clofarabine could be explored in higher doses than other nucleoside analogues and~     has shown considerable antileukemic activity in patients with relapsed or refractory acute~     leukemias and elderly AML patients alone or in combination with cytarabine. In addition, the~     combination of clofarabine, cytarabine and idarubicin has produced promising results with~     acceptable toxicity in patients with relapsed or refractory AML. Based on these initial~     studies, there is need for a further optimization of the clofarabine dose in this~     combination. The aim of the AMLSG 17-10 study is therefore to evaluate the tolerability and~     safety of increasing doses of clofarabine in combination with idarubicin/cytarabine in~     patients with high risk AML defined by the genetic and molecular risk profile.~   "
116235|NCT01534689|"~     The purpose of this study is to determine whether low level laser light is effective in the~     treatment of toenail fungus.~   "
116236|NCT01534676|"~     The purpose of this study is to determine the effects of transfusion of fresh and stored~     blood on patients.~      The investigators hope to test:~        -  whether a similar effect (older stored blood is associated with worse outcomes) is seen~          in chronically transfused patients with hemoglobinopathies. This patient population~          will also allow the investigators to test whether iron- chelation therapy is beneficial~          in this setting.~        -  whether washing or cryopreserving the red blood cells has any effect on this outcome.~      These findings may explain the immunomodulatory effects of older stored blood in patients~     and will help us develop safer transfusion products for patients.~   "
116237|NCT01534663|"~     The aim of this study is to determine whether supplementation of glutamine and fish oil can~     improve peripheral skeletal muscle function and metabolism in patients with heart failure.~     The investigators propose a randomized, double-blind, placebo controlled study comparing the~     combined supplementation of fish oil and glutamine with placebo in patients with stable~     heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g~     fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in~     this study is the change in muscle functional capacity measured as changes in maximum muscle~     strength and fatigability, peak VO2 and exercise time after supplementation. A secondary~     outcome is the measurement of systemic and local markers of inflammation.~   "
116238|NCT01534650|"~     The purpose of this study is to collect kinematic motion data from subjects with movement~     disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate~     algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements),~     dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks~     and/or activities of daily living.~   "
116239|NCT01534637|"~     This pilot clinical trial is studying how well aprepitant works in preventing nausea and~     vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.~     Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in~     patients receiving chemotherapy and radiation therapy~   "
116240|NCT01534624|"~     Background:~      - Researchers are interested in studying the roles that genes play in drug and alcohol~     addiction. Genes seem to account for about half of the differences between people who become~     addicted to drugs and people who do not. This study will collect blood and skin cell~     samples. These cells will be used to develop stem cells that are useful for studying how~     genes are related to drug use and dependence.~      Objectives:~      - To study genetic and cellular differences between people who are addicted to drugs and~     those who are not.~      Eligibility:~        -  Individuals between 21 and 65 years of age who do not use drugs.~        -  Individuals between 21 and 65 years of age who are in treatment with buprenorphine or~          methadone.~      Design:~        -  Participants will be screened with a brief physical exam and medical history.~        -  Participants will also answer questions about physical and mental health, quality of~          life, and history of drug and alcohol use. A urine sample and cheek swab sample will be~          collected.~        -  Participants whose genetic samples match the study requirements will be asked to come~          back to provide a skin biopsy sample and a second urine sample.~   "
116241|NCT01534598|"~     Background:~      - FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are~     experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU~     helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people~     on other cancer treatment trials, usually by vein. Researchers want to give FdCyd and THU by~     mouth to see if they work against cancers that have not responded to earlier treatments.~      Objectives:~      - To test oral FdCyd and THU on advanced solid tumors that have not responded to earlier~     treatments.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors that have not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and tumor samples will used to study the~          cancer before treatment.~        -  FdCyd and THU will be given in 21-day cycles. THU should be taken 30 minutes before~          taking FdCyd.~        -  Participants will take FdCyd and THU by mouth, once a day, for 3 days at the beginning~          of the first and second weeks of each cycle (days 1 3 and 8 10). The drugs will not be~          taken during the entire third week of each cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as the cancer is responding to the drugs and serious~          side effects do not develop....~   "
116289|NCT01533961|"~     This study is aimed at assessing the tolerability and pharmacokinetic parameters of~     SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental~     Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.~   "
116819|NCT01526941|"~     This trial is conducted in Europe. The aim of this trial is to compare the single dose and~     steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70~     in subjects with type 1 diabetes.~   "
116242|NCT01534585|"~     Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation~     therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer.~     Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC.~     However, concurrent chemoradiotherapy increased significantly local and systemic toxic~     effects, which may preclude many patients from proceeding with combined therapy. The~     epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is~     overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter~     survival following chemoradiotherapy in locoregionally advanced NPC. And some basic~     researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the~     radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line.~     Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib~     hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base~     on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in~     combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The~     prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT~     in patients with NPC. This regimen is of great interest and it has potential to alleviate~     the adverse effects, improve patient compliance and better therapeutic ratio.~   "
116243|NCT01534572|"~     There is a constant exchange between the gut epithelium and lumen, including microbial~     interplay. The aim of this study was to investigate dietary test products on inflammatory~     proliferation markers in the gut, and thereby if the products had positive effects in the~     gut as well as in other parts of the body.~      The hypothesis was that the test products would reduce the inflammatory and proliferation~     activity of the gut epithelium by fermentation of normal food products and by converting~     dietary phenolic compounds into anti-inflammatory substances.~   "
116244|NCT01534559|"~     It widely accepted that a number of medication related problems can occur after the patient~     has been discharged from the hospital. An obvious extension of the ongoing integrated~     medicines management programme (IMMP) is therefore to provide a medicines management clinic~     within an outpatient setting as well as follow-up telephone calls from a clinical~     pharmacist. This study aims to assess the influence a pharmacist-led medicines management~     outpatient service on patients at high risk of medication related problems.~      It is anticipated that this service will~        -  Ensure continuity of pharmaceutical care for patients post discharge.~        -  Reinforce patient education in order to improve knowledge and understanding of the~          medication prescribed.~        -  Ensure that both prescription medicines and OTC preparations are used appropriately.~        -  Facilitate the communication with other members of healthcare team in order to agree~          and implement measures to overcome medication related problems.~   "
116245|NCT01534546|"~     Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued by~     eastern and western scholars. For patients with clinical stage of cT4b/N+M0, or cT4aN+M0,~     the prognosis is rather poor, and the primary lesions might not be resectable at the time of~     diagnosis. MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of~     ECF has increased 13% on 5yOS compared with surgery alone; However, eastern studies such as~     ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX (oxaliplatin/capecitabine)~     combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery~     could achieve the significant survival benefit. So whether perioperative or post operative~     therapy is more beneficial for LAGC patients lacks of data supported by prospective study.~      So in this prospective randomized phase III study, the investigators aim to compare the~     survival benefit as well as the safety for SOX (oxaliplatin/TS-1) as perioperative therapy~     versus SOX or XELOX as postoperative therapy after D2 dissection.~   "
116246|NCT01534533|"~     This study is to investigate the possible positive effects of lutein and lycopene~     supplementation on early atherosclerosis in Beijing.~   "
116247|NCT01534520|"~     This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is~     effective at decreasing pain during intrauterine device insertion in nulliparous women.~   "
116248|NCT01534507|"~     Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite~     disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort~     along with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two~     (referred to as IBS subtypes). Despite much research efforts to further understand the~     pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been~     identified that can be use to aid the diagnosis and reduce the need for unnecessary,~     unpleasant and expensive tests.~      Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small~     bowel. In this study, the investigators hypothesise that since anxiety is a common feature~     of IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the~     difference in stool frequency and consistency in IBS subgroups are therefore likely to~     reflect differences in colonic function. The investigator wish to test this by measuring~     both small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate~     the results of the MRI with two methods currently used in clinical practice -The previously~     validated lactose-C13 Ureide breath test (for small bowel transit) and the standard~     radio-opaque pellet method to assess the whole gut transit (WGT) time.~   "
116260|NCT01534351|"~     This study is designed to compare safety and efficacy of monotherapy finasteride to~     combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic~     hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that~     concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to~     BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from~     baseline on the International Prostate Symptoms Score (IPSS) and will be superior with~     respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as~     measured by percent change from baseline in prostate volume.~   "
116261|NCT01534338|"~     The primary aim of the study is to test the effect of mindfulness training on sleep~     parameters among older adults with insomnia symptoms~      The secondary aims are to examine if changes in mindfulness meditation practice (daily log)~     and level of mindfulness (self-report) are associated with changes in sleep parameters, and~     to determine if mindfulness training is associated with in vitro biological markers of~     peripheral inflammation~   "
116262|NCT01534325|"~     The purpose of this study is to determine whether the SD unique device is effective in~     treatment of overweight and obesity.~   "
116249|NCT01534494|"~     This trial is an open-label pilot study (N = 10) designed to assess the effects of~     psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated~     behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.~     Participants will receive psilocybin orally in two all-day administration sessions,~     conducted in a secure outpatient psychiatric setting, in a dose range that has been~     well-tolerated in recent studies. Psilocybin administration will occur in the context of a~     behavioral intervention including a total of 12 sessions over 12 weeks, incorporating~     Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on~     Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as~     preparation before and debriefing after the psilocybin administration sessions. The MET will~     incorporate attention to spirituality as well as drinking behavior as a primary subject of~     change. Drinking outcomes and changes in several potential mediators of treatment effect,~     including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions~     of the experience, will be measured during treatment and for 24 weeks after the end of~     treatment. The investigators hypothesize that drinking will decrease following the~     psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality~     (primary contrast 12 weeks vs. baseline) will be observed among study participants.~   "
116250|NCT01534481|"~     The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26~     months of donor human milk as compared to preterm infant formula as the in-hospital diet for~     infants whose mothers choose not to provide breast milk or are able to provide only a~     minimal amount. Infants will be randomized to receive donor breast milk or formula during~     their hospital stay. Infant's will be followed until they reach 22-26 months of age.~   "
116251|NCT01534468|"~     H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs.~     This study will evaluate the safety and immune response to an H7N7 vaccine in people who~     have previously received a live attenuated influenza vaccine (LAIV) as part of a research~     study and people who have not previously received a LAIV.~   "
116252|NCT01534455|"~     -  Lapatinib in combination with capecitabine has been approved for the treatment of women~          with HER-2-positive advanced breast cancer that have progressed after anthracycline-,~          taxane-, and trastuzumab-containing therapies. The use of this combination is limited~          by overlapping toxicity such as diarrhea and cutaneous side effects.~        -  A significant number of patients receive today capecitabine with trastuzumab as first-~          or second-line treatment. Therefore, other combinations of lapatinib with less toxic~          cytotoxic agents are needed.~        -  Eribulin mesylate (E7389) is a synthetic analog of Halichondrin B (HalB), a large~          polyether macrolide isolated from a marine sponge. Eribulin is a mechanistically unique~          antagonist of microtubule dynamics among tubulin-targeted agents, leading to inhibition~          of microtubule growth in the absence of effects on microtubule shortening, and~          formation of non- productive tubulin aggregates.~        -  Eribulin mesylate at a dose of 1.4 mg/m² given on day 1, 8 every 3 weeks has shown~          better overall survival by 2.5 months compared to treatment of physicians choice in~          patients with locally advanced or metastatic breast cancer who were previously treated~          for 2-5 lines with anthracyclines, taxanes, and capecitabine (EMBRACE study).~        -  The most frequently reported eribulin-related AEs were asthenia/fatigue (65%), alopecia~          (60%), neutropenia (60%), nausea (44%), anemia (28%), pyrexia (23%), leucopenia (22%),~          anorexia (21%), constipation (19%), vomiting (18%), and peripheral neuropathy (5.5%;~          only grade 3). Grade 4 neutropenia occurred in 32% of patients, and febrile neutropenia~          occurred in 5.5% of patients. The frequency of all other grade 3/4 AEs was less than~          3%. This toxicity profile does not overlap with that of lapatinib.~        -  There is uncertainty in how far a once every 3 week schedule of eribulin mesylate at a~          dose of 2.0 mg/m² would be better tolerated. Several phase II studies are currently~          conducted in various non-breast cancer indications to compare the d1+8 q d21 with a d1~          q d21 schedule.~        -  The aim of this randomized phase II study is to compare the efficacy and tolerability~          of two dose-schedules of eribulin plus lapatinib in HER2-positive breast cancer,~          pre-treated with trastuzumab in the adjuvant and/or metastatic setting.~   "
116253|NCT01534442|"~     The aim of this study is to investigate the role of transmission of vagal cholinerg for the~     GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin~     response by using atropin administration.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the investigators will research individuals with an intact~     nervous supply with and without atropin administration.~   "
116254|NCT01534429|"~     Increasing experience has identified post-herniorraphy chronic pain as an under-recognized~     and important complication. Nerve entrapment and injury are recognized as causes of such~     pain. Operative treatment for selected patients with this condition includes surgical~     exploration of the affected groin, identification and removal of involved nerves, and~     removal of meshoma. This procedure has been highly effective in treatment of chronic pain.~     This study will attempt to subjectively and objectively evaluate the patient's chronic groin~     pain using quantitative sensory testing (QST) and validated pain scales and questionnaires.~     Quantitative sensory testing is a method used to assess damage to the small and large nerve~     fibers. It is used to diagnose and assess the severity of nerve damage, and can also help to~     determine if a neuropathy is responding to treatment. QST uses a computer testing system to~     measure how nerves react to vibration and changes in temperature. The procedure is~     non-invasive and the patient will feel minimal to no discomfort during testing. The~     hypothesis is that any decrease in subjective pain scores would be accompanied by improved~     QST results.~   "
116255|NCT01534416|"~     The purpose of this study is to determine the effectiveness of placing numbing medication~     around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain~     after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted~     myomectomies. It will assess whether patients who receive the medication experience less~     pain and require less pain medication post operatively and if it helps reduce the number of~     patients who require hospitalization for pain control following surgery.~   "
116256|NCT01534403|"~     The study is an open-labeled extension study to continue to assess the safety and~     tolerability of Epratuzumab in moderate to severe SLE subjects who have previously~     participated in SL0026 [NCT01449071] phase I/II trial.~   "
116257|NCT01534390|"~     Studies showed that infusion or injection of drugs and fluids results in introduction of~     microparticles into the bloodstream. These microparticles may cause organ damage and~     stimulate the immune system thus aggravating the underlying disease. Given that critically~     ill patients are characteristically suffering from a high disease severity and receive large~     amounts of fluids and drugs, they may be at particular risk of harm by these microparticles.~     In-line microfilters have been shown to clear microparticles from intravenous drugs and~     solutions. The investigators hypothesize that use of in-line microfilters reduce the days~     with the systemic inflammatory response syndrome in adult critically ill patients.~   "
117285|NCT01520844|"~     A consortium of research teams has studied the immunovirological characteristics of these~     patients:~      The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study~   "
116264|NCT01534299|"~     This is a prospective, multi-center, single-arm, non-interventional and open-label registry.~     The purpose of the registry is to document the long-term safety and effectiveness of renal~     denervation in a real world patient population with hypertension and gathering data for~     other diseases characterized by elevated sympathetic drive, such as diabetes mellitus type~     2, renal insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000~     patients who undergo the renal denervation procedure, from over 200 sites worldwide.~   "
116265|NCT01534286|"~     The purpose of this study will be to show the patient response to analgesics taken post~     surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The~     data collected will be used to show that patients have a shorter and lower post operative~     pain measurement and the time to discontinuation of analgesics is less in the active~     comparator group.~   "
116266|NCT01534273|"~     The purpose of this phase I study in healthy participants will be to evaluate the safety and~     tolerability of LY2886721 single and multiple doses, how the body handles the drug and the~     drug's effect on the body.~   "
116267|NCT01534260|"~     This research is being done because treatment options are very limited and usually~     unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with~     disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited~     to participate in this study that will examine the use of three drugs called Sorafenib~     (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid~     leukemia.~   "
116268|NCT01534247|"~     The purpose of the study is to assess whether there is any pharmacokinetic interactions~     between CAZ-AVI and metronidazole.~   "
116269|NCT01534234|"~     The objective of this study is to assess the safety and effectiveness of the automatic~     atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in~     the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device~     (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip~     of the atrial pacing lead, and compatible SmartView programming software.~      This study will evaluate the effectiveness of the automatic optimization algorithm in~     increasing the rate of patients responding to the therapy as compared to an~     echocardiographic optimization method.~      This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing~     lead.~   "
116270|NCT01534221|"~     The superiority of a percutaneous coronary intervention (PCI) by one stent over another in~     terms of clinical outcome is usually documented in large randomized controlled trials (RCT).~     Although generated from selected study populations these data form the basis for evidence~     based practice (EBP) in the entire population of patients considered for coronary~     intervention. An inherent limitation of this approach is that study populations differ~     significantly from all comers in terms of patient characteristics and prognosis undermining~     the foundation for extrapolation of trial results to all comers. Furthermore, other trials~     are based on a one-fits-all concept, while the benefits of an individual-tailored~     approach that might be superior, is not investigated.~      The Purpose of the current study is to~        -  Compare clinical outcome between several CE marked drug eluting stents~        -  Compare clinical outcome between several CE marked bare metal stents~        -  Compare clinical outcome in all comers with that of the selected study population of~          RCT's~        -  Evolve methods to compare clinical outcomes between the generalized one-fits-all~          versus the individualized or individual-tailored stent selection approaches~      The Method employed is~        -  All comer PCI registry - single centre~        -  Randomisation of all eligible patients within the registry to one of several study~          stent~        -  Quality assurance in non-randomized population within the registry by periodical~          alternating the institutional standard stent~        -  Continuous follow up of all patients included the registry by means of systematic event~          detection and classification by an independent safety and end point committee~        -  Assessment of effects on quality of life by heart and health questionnaires~      Outcome Measures~      Primary endpoints:~        -  Composite of cardiac death, acute myocardial infraction and target vessel~          revascularisation~        -  Stent thrombosis~        -  A specifically developed Treatment Failure Rate classification~      Secondary outcome measures include each of the above, target lesion revascularisation and~     total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.~      Tertiary outcome measure is self reported quality of life based on health questionnaires on~     general health and cardiac symptoms.~      Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an~     absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment~     arms.~      Prespecified Analysis include~        1. The MACE rates between stent types~        2. The Stent thrombosis rates between stent types~        3. The Treatment failure rates between stent types~        4. The randomized population versus non-randomized population~        5. The individualized versus the generalized Population~        6. QOL between stent types~   "
116271|NCT01534208|"~     ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men~     with secondary hypogonadism.~   "
116272|NCT01534195|"~     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival~     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to~     treatment with a proven ocular anti-inflammatory medication,~      Prednisolone, assessed by the following measures:~        -  Ocular itching~        -  Conjunctival redness~   "
116273|NCT01534182|"~     A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient~     Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing~     Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease~     Modifying Therapy.~   "
116274|NCT01534169|"~     Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe.~     However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients~     need further treatment. In our previous study, a new treatment strategy for GD has been~     introduced. After methimazole (18 months) combined with intrathyroid injection of~     dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly~     reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year~     follow-up period. The results have been published in the 'J Clin Endocrinol Metab,~     2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD~     is not fully understood. In vitro study, we have proven that DEX could effectively improve~     the function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in~     GD patients(this results have been in press in the Eur J Endocrinol). In order to elucidate~     mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and~     treat those patients by intrathyroid injection of DEX combined with methimazole, and the~     function of Treg cells and balance of Th1/Th2 will be evaluated.~   "
116275|NCT01534143|"~     This pilot phase II trial studies how well giving high dose busulfan together with~     bortezomib works in treating patients with high risk multiple myeloma undergoing stem cell~     transplant. Drugs used in chemotherapy, such as busulfan, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cells growth. Giving busulfan together with bortezomib before a stem cell transplant may~     kill more cancer cells~   "
116290|NCT01533948|"~     This phase II trial studies how well axitinib works in treating patients with melanoma that~     has spread to other places in the body or cannot be removed by surgery. Axitinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
116276|NCT01534130|"~     The investigators will conduct acupuncture for participants with chronic fatigue~     syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep~     structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to~     investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye~     movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture~     for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the~     fatigue, reducing accompanying symptoms and for improving the life quality of CFS.~   "
116277|NCT01534117|"~     The investigators are assessing the platelet function analysis of those who sustained~     significant head trauma while on aspirin or plavix and to assess if any qualitative~     difference is obtained if platelets are administered.~   "
116278|NCT01534104|"~     Many patients with brain tumors require surgery. Some patients have brain tumors near~     important parts of the brain. These brain areas have roles in language or motor function.~     Avoiding these motor and language areas helps to prevent neurological deficits. The~     investigators are studying the parts of the brain involved in motor and language. Patients~     usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping~     and diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter~     mapping. These special MRI sequences are used to plan surgery. Patients are scheduled to~     have imaging to help plan for possible surgery.~      Some patients may require stimulation during surgery to motor and language areas. In~     patients who require stimulation as part of their standard of care, the investigators will~     compare the investigators imaging results with the stimulation results. The purpose of this~     study is to improve MRI mapping of the motor and language pathways in the brain.~      The scans are necessary stimulation for this protocol are part of the standard of care. In~     other words, these tests are done as part of the best possible care even if they did not~     join this study. The investigators are studying new techniques for analyzing the MRI data.~     These new techniques may give the doctor a better view of where the brain tumor is located~     relative to important parts of the brain.~      The investigators will only perform the test sequences that are necessary for mapping the~     tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or~     DTI. The investigators may also ask to perform optional sequences during the scan.~     Multi-echo is an modified form of fMRI. DSI is a modified form of DTI. These optional~     sequences are for research only. The patient would not get these sequences if they do not~     enroll in this study.~   "
116279|NCT01534091|"~     The purpose of this study is to examine if internet supervised by pedometer will contribute~     to enhance the amount of physical activity at leisure time by obese children.~      The investigators hypothesize that using pedometer will increase the amount of physical~     activity done by obese children in the afternoon and will improve the likelihood of success~     in the intervention program.~   "
116280|NCT01534078|"~     Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a~     protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the~     antibody portion to enter into the Hodgkin lymphoma cells and then releasing the~     chemotherapy portion, which attempts to destroy the cell.~      The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you~     will receive in this research study are approved for use in people with Hodgkin Lymphoma. A~     drug called bleomycin is usually included with AVD, but since it appears to be a less~     effective drug with significant potential risks, it is being replaced in this study with the~     drug brentuximab.~      In this research study, the investigators are looking to see whether brentuximab in~     combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.~   "
116281|NCT01534065|"~     The purpose of this multi-center post marketing surveillance study is to monitor the safety~     and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the~     L1 - S1 spinal disc.~   "
116282|NCT01534052|"~     A study to assess the safety of continued administration of MDV3100 in subjects with~     Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.~   "
116283|NCT01534039|"~     A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or~     urostomy.~      Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin~     protection, wear-time, ease of use, ease of teaching, and comfort.~   "
116284|NCT01534026|"~     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function~     as a pump to move blood around the body. Aspirin has been traditionally used in heart~     failure because a tendency towards blood clots (including stroke and heart attack, clots in~     the legs and in the lungs) has been observed in this group and aspirin's mechanism of action~     is to prevent blood clots. This is important because two-thirds of cases of heart failure~     are caused by a blood clot in the coronary artery resulting in a heart attack, and aspirin~     is given to reduce the chances of further heart attacks.~      However aspirin was introduced before clinical trials as the investigators know them now~     were run. Systematic review of the trials of aspirin in heart failure has shown that its use~     does not increase survival, and there is no evidence to recommend its routine use. Another~     important finding was that use of aspirin may reduce the beneficial effects of ACE~     inhibitors which do have a mortality benefit, and that aspirin was associated with an~     increase in hospitalisation for heart failure compared to other drugs which prevent clots or~     placebo.~      The investigators propose that the use of aspirin in heart failure that is not caused by~     heart attacks (non-ischaemic cardiomyopathy) is unnecessary and could be stopped. The~     importance of finding evidence to cease unproven medications in heart failure cannot be~     understated. Patients with heart failure take an average of six prescription medications~     each day. Each medication has side effects and the interactions of all the drugs together~     are unknown. Aspirin itself is a drug which frequently has side effects of increased risk of~     bleeding, gastrointestinal ulceration, as well as kidney impairment.~      In this study, the investigators plan to withdraw aspirin from patients with stable~     non-ischaemic heart failure in a closely monitored environment and watch for the effect of~     this on heart failure.~   "
116285|NCT01534013|"~     The purpose of the study is to assess the safety and efficacy of the Imperial College closed~     loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.~   "
116286|NCT01534000|"~     Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a~     prospective randomized controlled trial designed to evaluate the clinical value of cardiac~     multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients~     with acute chest pain, compared to a conventional functional-based testing strategy.~      Methods:~      Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal~     electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary~     angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial~     perfusion imaging - MPI (Control group).~      After one year, patients will be followed-up, with registration of clinical endpoints such~     as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart~     related problems, sustained chest pain, live quality score, use of medication.~   "
116287|NCT01533987|"~     The purpose of the study is to determine the effects of daily ingestion of Juice Plus+®~     capsules containing Orchard, Garden and Vineyard blends on endothelial function and~     biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in~     overweight men as compared to the placebo group.~   "
116288|NCT01533974|"~     The overall aim of this 5-year project is to capitalize on the strong theoretical and~     promising empirical evidence for Acceptance & Commitment Therapy (ACT) as an intervention~     for smoking cessation by comparing the effectiveness of ACT against standard cognitive~     behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy~     (NRT) and delivered within a real world healthcare setting.~   "
116293|NCT01533909|"~     The aim of the study is to develop a screenings tool that will enable hospital nurses to~     detect and stage cancer cachectic patients. The early detection and staging of cancer~     cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made~     patient care.~   "
116294|NCT01533896|"~     Parents should receive anticipatory guidance about obesity prevention as part of the routine~     well child visit. Educational resources are needed to help physicians routinely provide~     these important anticipatory guidance messages. In this study, consecutive parents will be~     exposed to routine anticipatory guidance messages before the well child visit with the~     physician. After the clinic visit, parents will be invited to participate in a research~     study to determine if they plan any changes at home. The key research question of this study~     is: Can a brief multimedia intervention help parents develop plans to help their children~     have a healthy weight?~   "
116295|NCT01533883|"~     Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a~     transfemoral delivery system. The aim of this study is to evaluate the performance and~     safety of the Cardioband for repair of mitral regurgitation.~   "
116296|NCT01533870|"~     Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics~     of NKTR-118.~   "
116297|NCT01533857|"~     This study is set up to determine pharmacokinetics of phenolic acids after a single oral~     dose to healthy males.~   "
116298|NCT01533844|"~     The objective of this multi-center, prospective observational study is to determine the~     feasibility of a potential interventional study with fidaxomicin. The incidence and clinical~     aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will~     be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy~     might improve outcome.~   "
116299|NCT01533818|"~     The aim of the study is to determine optimal management of isolated fast breathing in young~     infants in a trial design conducted in primary care settings.~      The investigators hypothesized that proportion of infants who fail therapy will be 4% in~     each group. A 6% or less difference in failure rate will be considered equivalent.~   "
116300|NCT01533805|"~     The purpose of this study is to compare different methods of application of the Pilates~     Method with exercises in controlling in low back pain in women aged between 45 and 60 years.~     Two groups will be formed. One will do Pilates exercises with stabilization segmental. The~     other group will do classic Pilates exercises. Will be measure pre and pos intervention of~     the responses already shown above.~   "
116301|NCT01533792|"~     Objective: The objective of this research was to compare the effect of a single session~     supragingival scaling in a group of pregnant women with periodontal disease with a group~     that received supra and subgingival scaling.~      Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4~     teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing~     in the same place. Women were divided into two groups, the group 1 received supra and~     subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received~     only supragingival scaling with OHO too.~   "
116302|NCT01533779|"~     Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil~     functions like chemotaxis, superoxide production, hydrogen peroxide production, and the~     presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and~     hematological malignancies. This data could shed new light on the mechanism responsible for~     the increased susceptibility to infection among these patients and aid in improving their~     prophylactic antimicrobial treatment.~      NETs formation against tumor cell lines and their ability to kill tumor cells will also be~     examined. The finding of NETs activity against tumor cells could have a major contribution~     to the investigators understanding of the function of the immune system against cancer.~   "
116303|NCT01533766|"~     The purpose of this study is to compare the safety and efficacy of CombiflexOmega in~     comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.~   "
116304|NCT01533753|"~     The purpose of this study is to assess the change in quality of life over a 6 month period~     between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes~     related to androgen deprivation therapy.~   "
116305|NCT01533740|"~     Aim of the present study is to investigate whether baseline or early post-treatment (one~     month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs~     OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence~     long-term clinical outcome (i.e. radiological response, progression-free survival or overall~     survival) in metastatic colorectal cancer patients treated with a standard first-line~     chemotherapy including fluorouracil, irinotecan and bevacizumab~   "
116306|NCT01533727|"~     Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main~     treatment for early stage patients is surgical resection, but about 30% -70% patients will~     relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection~     NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic~     adjuvant chemotherapy. It is necessary to further improve the survival time of patients with~     lung cancer. Biological treatment is becoming a new treatment modality for Cancer following~     with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant~     treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK)~     characterized as fast amplification, strong anti-cancer activity and broad anti-tumor~     spectrum is most widely used and thought to be the first choice for the new generation of~     anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of~     Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy~     for stage IB-IIIA NSCLC.~   "
116307|NCT01533714|"~     The primary objective of this study is to assess the long-term safety of CDP6038.~   "
116308|NCT01533701|"~     The purpose of this study is to compare lactate and total acid-base status in fetal scalp~     blood with lactate and total acid-base status in maternal blood and amniotic fluids to~     provide information on how lactate and base deficit correlates with scalp samples.~      Furthermore, the investigators want to study whether angiogenic factors in fluids above may~     be a possible marker of asphyxia during labor.~   "
116453|NCT01531959|"~     We hypothesize that midodrine treatment of refractory hypotension in patients otherwise~     ready for discharge from the ICU shortens duration of receiving IV vasopressors and SICU~     length of stay without increasing MGH length of stay or putting the patient at risk of being~     readmitted to an ICU.~   "
116309|NCT01533688|"~     Poor bowel preparation and patient intolerance of the procedure are the most important~     factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in~     incomplete testing, increased potential to miss lesions, increased cost, and decreased~     patient satisfaction. The investigators hope to gain better insight into which bowel~     preparation works best in diabetic patients and hence would increase patient satisfaction,~     tolerability of the bowel preparation and decrease overall costs. The investigators will~     investigate which bowel preparation for colonoscopy will work optimally in diabetic patients~     using three different regimens.~   "
116310|NCT01533675|"~     Sutures are an integral part of surgery and available materials are diverse, as are the~     options for post-procedure care. Both saline and hydrogen peroxide are commonly used~     cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on~     the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.~   "
116311|NCT01533662|"~     Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This~     loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation~     resulting in hypotension. A severe and prolonged hypotension can compromise regional~     perfusion and worse outcome especially in very elderly patients. Moreover the venous~     vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a~     cardiac output decrease. Several authors had identified the prevention of hypotension as a~     key role during spinal anesthesia although none prophylactic treatment has been identified.~     Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous~     spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension.~     Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic~     agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine~     infusion for preventing hypotension has been demonstrated during spinal anesthesia for~     cesarean delivery. The investigators want to assess for the first time the prophylactic~     phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic~     lower limb surgery under spinal anesthesia single injection.~   "
116312|NCT01533649|"~     The assumption of the unpredictability of seizures may have an enormous impact on the~     perception of self-efficacy and may contribute more to a patient's poor quality-of-life than~     the actual seizures. Patients with epilepsy are especially susceptible to the influence of~     the arbitrary nature of this condition on socialization,education,and the formation of~     self-identity. Consequentially, the psychosocial and psychological aftermath is likely to be~     observed even in individuals with well-controlled seizures. The relationship between seizure~     occurrence and the effects of having epileptic seizures on quality of life can be~     characterized as reciprocal; e.g. emotional stress is not only a result of having seizures;~     it is also the most frequently reported seizure precipitant. Whereas behavioral~     interventions have repeatedly been considered as the third pillar of the treatment of~     epilepsy, the main focus still remains on passive seizure control per pharmacological and~     surgical interventions, which may further aggravate victimization. Outcome after epilepsy~     surgery is closely correlated with pre-surgical characteristics. Consequentially, there is~     an upsurge of interest in the medical community for research on non-pharmacologic~     interventions to facilitate the transition from chronically sick to well with preventive~     therapeutic interventions in the context of habitual seizures. The Andrews/Reiter (AR)~     approach to epilepsy is a systematic counseling intervention that assists the individual to~     identify seizure warning signs,seizure precipitants and general life stressors in order to~     develop strategies of active seizure control and improve self-defined life quality.~     Literature review indicates that AR represents the most comprehensively developed~     psychological approach. The proposed trial will address the question if AR decreases seizure~     frequency and psychopathologic comorbidities and increases seizure self-efficacy and overall~     quality of life in patients with medically intractable epilepsy.~   "
116313|NCT01533636|"~     The investigators will collect samples of sputum from healthy volunteers and patients with~     cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding~     studies and; b) assessment of the effects of carbohydrates on the rheologic properties of~     the sputum.~      This study has two hypotheses:~        1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in~          a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic~          compounds.~        2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and~          Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF~          sputum.~   "
116314|NCT01533623|"~     The investigators will perform a 1-year clinical trial measuring objective compliance during~     mandibular advancement device (MAD) treatment.~      The investigators will enroll 50 patients that received treatment with a titratable, duobloc~     MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original~     study Objective versus subjective compliance with oral appliance therapy for obstructive~     sleep apnea hypopnea syndrome, registered at Clinical Trials.gov (NCT01284881).~      Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided~     by the Handelsagentur Gschladt without any costs. The sampling interval of the recording~     will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this~     sample interval, the capacity of the active microsensor allows for data acquisition during a~     100 day period.~      A follow-up appointment is scheduled +/- 265 days after the start of the original study. A~     second follow-up visit is scheduled again 1 year after the start of the original study.~      The objective measurement of MAD wear time (total hours of wear time and the mean hours of~     wear per night over the respective period) will be based on the assumption that the MAD has~     been worn when the chip records a temperature intraorally.~   "
116315|NCT01533610|"~     RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic~     stress disorder (PTSD).~      PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve~     block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era)~     induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part~     of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).~   "
116316|NCT01533597|"~     The aim of the study is to investigate if the combination therapy consisting of~     anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive~     Bladder (OAB).~   "
116317|NCT01533584|"~     The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood~     pressure and home blood pressure (BP) measurements through a) comparison of mean BP and~     nocturnal dipping assessed with the two methods, b) correlation of those parameters with~     parameters of target-organ damage and c) comparison of the potential of the two methods to~     define non-dippers.~   "
116349|NCT01533168|"~     RATIONALE: Testing for minimal residual disease in cell samples from patients with acute~     lymphoblastic leukemia may help doctors plan better treatment.~      PURPOSE: This research trial studies a genetic test in identifying previously undetectable~     minimal residual disease in cell samples from younger patients with acute lymphoblastic~     leukemia.~   "
116318|NCT01533571|"~     This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate~     resorption and soft tissue recession following immediate implant placement in extraction~     sockets in the maxillary esthetic zone using different socket morphology-guided treatment~     modalities.~      Expected results of the study are:~        -  To have found the optimal materials and GBR procedures modalities for buccal plate~          resorption degree reduction;~        -  Soft tissue recession and best esthetic result achievement. There will be possibilities~          to study socket morphology influence on final esthetic result achievement.~   "
116319|NCT01533558|"~     The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to~     non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU~     patients, who will get caspofungin as standard care.~      Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be~     taken daily.~   "
116320|NCT01533545|"~     The aim of this study is to determine the effect of epinephrine on systemic absorption of~     local anaesthetic mepivacaine administered for brachial plexus block in uremic patients~     scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of~     epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.~   "
116321|NCT01533532|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients~     with endometriosis.~   "
116322|NCT01533519|"~     This study is designed to investigate the safety of intranasal administration of NPY using a~     dose escalation, randomized, double-blinded, placebo-controlled crossover design in a~     medication-free, symptomatic PTSD group.~   "
116323|NCT01533506|"~     The patient has failed all other available agents and has intractable epilepsy due to Dravet~     Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy~     with Stiripentol are primarily to significantly reduce the frequency and severity of~     seizures.~   "
116324|NCT01533493|"~     This is a 12-week clinical trial evaluating the efficacy and safety of memantine~     hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults~     with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with~     OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of~     treatment with memantine on ADHD symptoms. Following screening procedures, memantine is~     prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for~     12 weeks, along with open-label OROS-MPH (everyone receives medication).~   "
116325|NCT01533480|"~     The investigators are conducting this study because the patient have an eye infection which~     is called adenoviral conjunctivitis, and is the most common cause of pink eye. There is~     currently no treatment for this condition. However, the researchers associated with this~     study want to understand if using a product called Zirgan, which is a topical ointment that~     is already FDA-approved for other types of eye infections, will help with the type of~     infection that the patient currently have. Zirgan is not FDA-approved to treat your type of~     eye infection. Your participation in this study is expected to last 21 days but the patient~     will only apply the topical ointment for 14 of those days. During the study, the patient~     will be asked to come into this clinic 8 times.~      The purpose of this study is to determine whether topical Zirgan can reduce days that the~     patient suffers from the eye infection, and also to see if it can prevent the infection from~     spreading to your second eye and to also see if it can prevent the spreading of the~     infection to people that the patient come in close contact with.~      Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye~     lubricant gel and is commonly used for treatment of dry eye.~      The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times~     a day for the first 7 days and then 3 times a day for the following 7 days. The patient will~     be asked to return to the clinic 21 days after the patient starts the study for a final~     check-up.~      It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this~     study between 8-12 sites across the United States.~      The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to~     flipping a coin.~      The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor~     or study staff will be able to pick which study group The patient is in. The patient will~     not know and the study doctor or study staff will not know which study group the patient is~     in. The study doctor or study staff can find out if it is necessary to know for your health.~     If this happens, the study doctor or study staff may not be able to tell the patient which~     study group the patient was in until everyone finishes the study.~   "
116326|NCT01533467|"~     Objective:~      To investigate the protective effects of a newly invented device for reducing tears in the~     perineum during vaginal childbirth.~      Design:~      A multicenter randomized control trial performed at three hospitals in Sweden, in~     Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery~     (N=1200), cephalic presentation. They will be randomized to an intervention group, with a~     perineal protection device, and a control group deliver as normal.~      Main outcome measures:~      The effect on the frequency and extension of perineal ruptures grade I, II and anal~     sphincter rupture are measured.~   "
116327|NCT01533454|"~     The purpose of this study is to test the extent to which incentives, when combined with an~     existing evidence-based weight loss program, improve weight loss and weight loss~     maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss~     programs to the basic program without incentives.~   "
116328|NCT01533441|"~     The objective of the SAFE K study is to demonstrate that in patients treated with the~     antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as~     naturally produced by the ferments used in fermented dairy products, does not upset the~     balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum~     or placebo for four months after a 4-month run-in period.In addition, the study evaluates if~     regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation~     treatment and improve the markers of bone mineralisation.~   "
116329|NCT01533428|"~     The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin~     8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain)~     caused by diabetes.~   "
116330|NCT01533415|"~     Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and~     or current treatments including medication and psychotherapy.~   "
116331|NCT01533402|"~     The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a~     feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia,~     panic disorder, specific phobia, generalized anxiety disorder or separation anxiety~     disorder). The program is directed toward both the parents and children. The patients work~     with the treatment is supported through on-line contact with a therapist. Approximately 128~     patients will be included in the study and randomized to either condition. All included~     patients are assessed before the treatment starts and after 10 weeks (post treatment).~     Follow-up assessments are conducted at 3 and 12 months after treatment.~   "
116350|NCT01533155|"~     Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics~     of NKTR-118~   "
117124|NCT01522937|"~     This is a Phase II trial to characterize the safety and efficacy of individualized~     stereotactic body radiation therapy (SRBT) for patients who have had previous liver~     treatment or who have primary hepatocellular carcinoma (HCC).~   "
116332|NCT01533389|"~     A lower ureteral calculus, which measures 5 millimeters and less, may be easily expelled by~     symptomatic therapy. Actually, it has about a 50% chance of successful expulsion.~      However, a complication such as urinary tract infection or hydronephrosis or persistent pain~     may occur before it is expelled. Thus, it is imperative to minimize the occurrence of~     complications in the process of expectant treatment and also to reduce the time required to~     expel calculi.~      Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily.~      This clinical trial is to evaluate the efficacy of silodosin, a selective α1A-blocker, on~     calculous expulsion in expectant treatment for patients with lower and mid ureteral calculi.~   "
116333|NCT01533376|"~     Primary Objective:~      • To assess the possible utility of topical timolol in the management of port-wine mark~     (PWM) in Sturge-Weber syndrome in children.~   "
116334|NCT01533363|"~     The purpose of this study was to determine the influence on Patient comfort after Stapled~     Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular~     hemorrhoids.~   "
116335|NCT01533350|"~     Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late~     follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other~     fourteen with trilaminar endometrium (group 2), were included from our Department. The~     endometrial tissues were collected and Four biomarkers for endometrial receptivity and~     ultrastructure were assessed before and 6-7 days after ovulation.~   "
116336|NCT01533337|"~     The aim of the current report is to investigate the feasibility of transferring the free~     dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to~     reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed~     digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of~     the donor middle and ring fingers was measured.~   "
116337|NCT01533324|"~     S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in~     Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good~     efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is~     better than common course 4 week regimen in tolerance. So the investigators want to examine~     the efficiency and safety of SL one week on and one week off regimen in HCC.~   "
116338|NCT01533311|"~     The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with~     gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer~     than flat and polypoid lesions.~   "
116339|NCT01533298|"~     The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in~     comparison to SmofKabiven peripheral in postoperative patients requiring parenteral~     nutrition.~   "
116340|NCT01533285|"~     The purpose of this study is to explore the effect of an inflammatory and a psychosocial~     stressor and the combination thereof on mood in healthy young and elderly participants and~     patients with Major Depressive Disorder (MDD).~   "
116341|NCT01533272|"~     As a measure of secondary prophylaxis, and with the final objective of avoiding the~     infection, it has been suggested to use antiretroviral therapy. This is known as~     post-exposure prophylaxis (PEP).~      Although there are different recommendations, almost every guideline recommend using 3 drugs~     as PEP both in USA and Europe.~      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are~     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.~      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus~     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with~     a 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated,~     coul be an adequate drug for PEP.~   "
116342|NCT01533259|"~     This study will evaluate the efficacy of Stribild®~     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF))~     single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus~     Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in~     virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety,~     tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.~   "
116343|NCT01533246|"~     This phase II trial studies how well linsitinib works in treating patients with asymptomatic~     or mild symptomatic metastatic prostate cancer. Linsitinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
116344|NCT01533233|"~     The purpose of this study is to study the safety and results of thoracoscopic lobectomy~     using non-intubated thoracic epidural anesthesia versus intubated general anesthesia for~     lung cancer patients.~   "
116345|NCT01533220|"~     The common cold is a major cause of nasal obstruction and reaches children and adults twice~     or more times a year. At the moment, there is no cure for the common cold, and therefore the~     reduction of symptoms is the focus of treatment.~      The study was designed to parallel distribution, with two equal groups, with one group will~     receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate +~     panthenol and the other will receive treatment with naphazoline hydrocloride.~   "
116346|NCT01533207|"~     This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel~     followed by doxorubicin hydrochloride work compared to observation in treating patients with~     high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy,~     such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.~   "
116347|NCT01533194|"~     This pilot phase I trial studies the side effects and the best dose of giving viral therapy~     to patients with relapsed or refractory multiple myeloma. Viral therapy, such as wild-type~     reovirus, may be able to kill cancer cells without damaging normal cells.~   "
116348|NCT01533181|"~     The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow~     down the growth and/or progression of the tumors of participants with relapsed or recurrent~     Small Cell Lung Cancer.~      This study also plans to find out what effects, good or bad (side effects), OSI-906 has on~     participants and or Small Cell Lung Cancer. The study will also investigate if some proteins~     measured in the blood or tumor and some imaging features obtained from computed tomography~     (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small~     Cell Lung Cancer.~   "
116351|NCT01533142|"~     Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is~     now an established treatment at several other hospitals in the health region (Voss Hospital~     (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse~     Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund:~     gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion~     with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in~     Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from~     different surgical methods.~      This project is part of the regional strategic research initiative in the Helse Vest~   "
116352|NCT01533129|"~     The study searched for answers to two questions~        1. What is the effect of testosterone replacement therapy on endothelial dysfunction,~          inflammation and insulin resistance?~        2. Regarding the above parameters, is there any difference between daily transdermal~          testosterone implementation and intramuscular injection performed in three weeks.~   "
116353|NCT01533116|"~     To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa~     pharmacokinetics~   "
116354|NCT01533090|"~     The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the~     procedure is safe and effective. It has been the standard cleansing regimen for the last 25~     years. To overcome the difficulty in completing the bowel preparation due to large volume~     and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been~     shown to provide adequate colon cleansing and better tolerability.~      LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with~     bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing~     prior to colonoscopy thanks to the reduced volume and improved taste. The present study is~     intended to compare the new dosing regimen of the bowel lavage solution given the same day~     compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.~   "
116355|NCT01533077|"~     To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA~     9-1067 or 1 hour after.~   "
116356|NCT01533064|"~     Objective: Reports have described how hospitalized psychiatric patients respond to~     disasters; however, few reports have described the response to disaster among psychiatric~     outpatients, who have relatively mild disease in comparison with hospitalized, severely ill~     psychiatric patients. Here the investigators have analyzed the response to disaster among~     this under-studied population.~      Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The~     investigators studied psychiatric change among a population of psychiatric outpatients in~     Tochigi prefecture, located ~160 km (~100 miles) southeast of the Fukushima nuclear power~     plant, in an area that suffered moderate damage from the earthquake. A total of 328~     psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2~     (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4~     (neurotic, stress-related, and somatoform disorders). All diagnoses were made using~     International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were~     measured as a change in psychotropic medication after the disaster.~   "
116357|NCT01533051|"~     The aim of this study is to investigate the off-treatment sustained virological and~     biochemical response in chronic hepatitis B patients following the guideline by the Asian~     Pacific Association for the Study of the Liver (APASL) in Korea.~   "
116358|NCT01533038|"~     The purpose of this study is to compare the UroLift System Treatment to Transurethral~     Resection of the Prostate (TURP) in improving a patient's overall quality of life, while~     evaluating healthcare expenditures associated with each therapy.~   "
116359|NCT01533025|"~     The clinical outcomes of anterior cruciate ligament reconstruction using free tendon~     Achilles allograft are comparable to those using Achilles allograft with bone block on its~     end.~   "
116360|NCT01533012|"~     The purpose of this study is to investigate a performance of initial positioning of left~     sided double lumen endobronchial tubes using peak inspiratory pressures difference between~     two lungs.~   "
116361|NCT01532999|"~     Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with~     antidepressants which have limited efficacy and yield extremely low remission rates. New and~     improved treatments are sorely needed, especially in light of the inadequate evidence to~     support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD.~     Complementary and Alternative Medicine practices, such as meditation, may fill this void.~     Several other illnesses often found in association with PTSD, such as chronic pain, anxiety,~     and depression, have shown positive response to meditation, specifically Mindfulness Based~     Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single~     6-hour silent retreat session based on a systematic procedure to develop enhanced~     non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~     MBSR is well tolerated, already well disseminated. MBSR has been shown to be effective in~     reducing conditions that are commonly associated with PTSD, including pain, depression,~     anxiety and panic, and insomnia. The investigators are conducting a multisite study of~     Mindfulness Based Stress Reduction (MBSR) compared to Present Centered Group Therapy (PCGT)~     for the treatment of PTSD. The primary aim of this study will be to determine how well the~     MBSR form of meditation, i.e. MBSR, works to treat symptoms of PTSD in veterans compared to~     PCGT. The investigators will evaluate the effects of treatment on levels of mindfulness,~     depression, PTSD symptom clusters, and response rates. The investigators will evaluate~     veterans' satisfaction and acceptability of the MBSR intervention. Additionally, biomarkers~     will be utilized to aid in our understanding of the pathophysiology of meditation and~     explore the relationship between treatment outcome and neuroimmune response.~   "
116370|NCT01532882|"~     Diosmin has a well established use status in improvement of the symptoms of venolymphatic~     insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of~     capillary fragility.~      Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo,~     to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).~      The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin~     600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre,~     controlled, randomised, double blind, placebo-controlled, parallel-group study.~   "
116371|NCT01532869|"~     This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group~     study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in~     participants with systemic sclerosis. Participants will be randomized to receive either~     RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week~     96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly.~     Anticipated time on study treatment is 96 weeks.~   "
117151|NCT01522586|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.~   "
116362|NCT01532986|"~     Health care benefits and services are received through the Veterans Health Administration~     (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans~     across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a~     chronic condition that affects motor function as well as cognition, mood, sleep, and~     autonomic function. There are not enough subspecialists to manage every Veteran with~     Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates~     using needs assessments, evidence-based protocols, and VHA and community access coordination~     mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease~     care and patient-centered outcomes. If efficacious, this model may be practical to~     disseminate via an existing VHA national consortium network for Parkinson's disease.~      Objectives are (1) to implement then analyze via a randomized controlled trial whether a~     nurse-led, coordinated care management intervention, Care Coordination for Health Promotion~     and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence~     to evidence-based practice guidelines and improve health outcomes in Veterans with~     Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of~     implementation of the CHAPS intervention and its costs to determine how the intervention can~     be made sustainable and disseminated throughout Veterans Affairs Medical Centers if~     efficacious.~   "
116363|NCT01532973|"~     The purpose of this study is to assess the safety, pharmacokinetics (PK) and~     pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants.~     There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected~     participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll~     only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may~     be staggered.~      Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in~     HCV-infected participants, elbasvir administered for 5 consecutive days has superior~     antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by~     change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5,~     24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is~     anticipated).~      Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants,~     the mean maximum reduction in HCV viral load is greater following multiple dose oral~     administration of elbasvir as compared to placebo.~      Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in~     HCV-infected participants, elbasvir administered for 5 consecutive days has superior~     antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by~     change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose~     timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).~   "
116364|NCT01532960|"~     Despite advances in surgical, radiation and medical therapies of early stage breast cancer,~     some patients will experience disease recurrence. Because recurrence may not happen for~     years after definitive treatment, there is a period of time between resection and relapse~     when micrometastatic disease may be amenable to immune eradication or modulation. While the~     ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast~     immunotherapy is to define treatments that have immunologic efficacy. In this study, the~     investigators will determine whether a vaccine consisting of nine-class I breast specific~     peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with~     poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.~   "
116365|NCT01532947|"~     This in vivo study examined the contribution of remaining coronal dentin and placement of a~     prefabricated or customized fiber post to the six-year survival of endodontically treated~     premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic~     treatment. Groups were classified according to the number of remaining coronal walls before~     abutment build-up. Within each group, teeth were allocated to three subgroups: A) no~     post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression~     analysis was applied to assess whether the amount of residual coronal dentin and the type of~     endocanalar retention had a significant influence on failure risk of the restored teeth.~   "
116366|NCT01532934|"~     Substance use among criminal offenders constitutes a major public health problem and is tied~     to negative consequences for offenders, their families, and their communities. One of the~     direst of these consequences is repeated incarceration; thus, interventions that reduce~     criminal recidivism are needed. Forensic populations are often viewed with considerable~     therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and~     the assessment of individual differences among offenders may provide valuable information~     that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has~     emerged as an important personality construct for the understanding of violence and criminal~     recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and~     lack of remorse may have negative implications for the efficacy of psychosocial~     interventions. A foundational premise of the present work is that understanding the~     moderating role of psychopathic traits on substance use treatment outcomes among offenders~     is essential to determining what works, and for whom. The current proposal is a Phase II~     randomized clinical trial that aims to examine the impact of psychopathic traits on the~     efficacy of a brief substance use intervention for offenders in a jail diversion program.~     Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based~     treatment will reduce substance use and related consequences relative to a Standard Care~     only condition, 2) that the reduction in substance use in the intervention group will~     mediate a reduction in later criminal recidivism relative to the Standard Care condition,~     and 3) that core psychopathic traits will moderate the efficacy of the intervention such~     that individuals with lower levels of these traits will derive greater benefits with regard~     to decreased substance use, decreased drug use consequences, and decreased criminal~     recidivism at a one-year follow-up.~   "
116367|NCT01532921|"~     Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in~     order to position this product on the market, a post-market release study will be completed.~     The purpose of this study is to evaluate the hemodynamic performance of the Contour 3D®~     Tricuspid Annuloplasty Ring following Tricuspid Valve repair in a post-market environment.~   "
116368|NCT01532908|"~     The purpose of this study is to assess efficacy of a human monoclonal antibody against~     Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or~     sofosbuvir [part 2: an HCV NS5B polymerase inhibitor] in a 56 day treatment duration in~     patients undergoing liver transplantation due to chronic HCV infection. There is an option~     for extended study treatment through 84 days if viral load is undetectable at day 56.~   "
116369|NCT01532895|"~     The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat~     cancer pain in patients who have not been treated with a strong opioid.~   "
116528|NCT01530776|"~     The purpose of this study is to assess the feasibility and efficacy of an~     electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared~     to usual obstetric care, on changes in weight and cardiometabolic biomarkers among~     overweight and obese Black women.~   "
116372|NCT01532856|"~     This protocol is an international, multicenter, comparative, open and randomized study~     designed to compare the safety and efficacy (in terms of response rate) from three induction~     chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus~     Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is~     also designed to compare the safety and efficacy (in terms of duration of response) of two~     maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each~     treatment arm will include 100 patients and assessments and scheduled visits will be~     conducted in three periods: Pre-treatment, treatment and monitoring. Security will be~     evaluated by monitoring all adverse events, physical examination, vital signs and~     biochemical studies. Response to treatment will be evaluated according to the EBMT21~     criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles~     of induction therapy and monthly during the first year of maintenance therapy and every 3~     months thereafter.~   "
116373|NCT01532843|"~     Treatment with a nucleoside analogue and subsequent viral decline has shown to partially~     restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies~     investigating whether the effect of lowering viral load with nucleoside analogue therapy~     prior to the initiation of peginterferon results in higher sustained off-treatment responses~     showed contradictory findings.~      The aim of this study is to investigate sustained off-treatment response to peginterferon~     alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide~     analogues, thereby lowering viral load~   "
116374|NCT01532830|"~     The purpose of this pilot study is to assess feasibility and clarify the design of future~     study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or~     prevention of migraine symptoms.~   "
116375|NCT01532817|"~     The purpose of this pilot study is to collect preliminary clinical data related to the~     safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the~     AlphaCore™ device for the relief of acute bronchoconstriction due to asthma.~      Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in~     the study may be enrolled at up to 5 investigational (study) sites. The study sites are~     clinic settings capable of treating any potential complications of bronchoconstriction, an~     acute exacerbation of asthma, and any emergencies associated with use of the investigational~     device.~   "
116376|NCT01532804|"~     This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and~     oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic~     colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.~   "
116377|NCT01532791|"~     Carriers of the m.3242A>G mutation often have clinical symptoms which can include migraines,~     seizures, strokes, hearing loss, balance issues, gastrointestinal issues, and many other~     symptoms. The investigators would like to learn more about these disorders and have designed~     a Natural History Study to monitor these conditions over time so that physicians and~     scientists can not only understand the problems that patients have, but work on developing~     treatments. The focus of the current work is to evaluate known mutation carriers of the~     m.3243A>G (mitochondrial DNA) and their maternal relatives (carrier status not a requirement~     for participation). Paternal relatives will serve as controls. This study involves no~     treatment.~   "
116378|NCT01532778|"~     The perception of fat represents major scientific and nutritional issues. This research aims~     to identify salivary markers that could predict and possibly explain this perception in~     healthy human being. This would help to develop nutritional strategies for a more rational~     consumption of fat.~   "
116379|NCT01532765|"~     Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on~     the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause~     symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has~     been performed to remove the membranes with few complications, and surgical results are~     generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM~     surgery have been popularized by a number of retrospective studies and one prospective case~     series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel~     compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable~     and transparent ILM is difficult and increases the risk of trauma to the retina. In~     addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM~     visualization, is costly and has been shown to be toxic to the retina. The investigators~     study will be the first randomized-controlled multi-centred clinical trial to compare the~     outcomes of ERM surgery with and without ILM peeling. The results will help guide and~     standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks,~     as well as to help economize healthcare cost.~   "
116380|NCT01531933|"~     This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12~     weeks of therapy to investigate clinical efficacy and safety of DLBS3233.~      It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as~     measured by the improvement of prandial (particularly the first phase) insulin secretion as~     well as insulin resistance in prediabetic subjects which may prevent the conversion of~     prediabetes into type 2 diabetes mellitus.~   "
116381|NCT01531920|"~     A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor~     function, and cognitive effects of perampanel when administered alone and with alcohol.~   "
116382|NCT01531907|"~     This study has been designed to study differences bone turnover in relation to glucagon-like~     peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the~     preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to~     determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on~     bone resorption.~      Hypotheses:~        1. Acute responses of GLP-2 and bone resorption markers following feeding are affected by~          body fat mass.~        2. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a~          reduction in trabecular and/or cortical bone mass~        3. GLP-2 has direct actions on osteoclast resorption via a functional receptor~   "
116434|NCT01532206|"~     Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous~     coronary intervention and coronary artery bypass surgery. Animal studies suggest remote~     ischemic preconditioning increases levels of interleukin 10. The investigators aim to~     determine whether remote ischemic preconditioning results in an increase in IL-10 levels in~     patients following acute myocardial infarction.~   "
116383|NCT01531894|"~     GSK2110183 is an orally administered, pan-AKT kinase inhibitor that has demonstrated~     nonclinical activity in hematologic as well as solid tumor cell lines and xenograft models.~     In the First Time In Human (FTIH) trial, monotherapy with GSK2110183 dosed orally, once~     daily has shown encouraging activity in subjects with hematologic malignancies. This~     multicenter, non-randomized, open-label, treatment continuation or 'rollover' study is~     designed to provide continued access to eligible subjects who have previously participated~     in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research~     organization working on behalf of GSK. Eligible subjects must be receiving clinical benefit~     from continued treatment and have an acceptable safety profile with GSK2110183. Subjects who~     have participated in a GSK2110183 combination study with an approved anti-cancer agent will~     also be eligible to enroll in this rollover study. Subjects who participated in combination~     studies with two investigational compounds (one being GSK2110183) will not be eligible for~     this rollover study. Subjects will be enrolled by cohort based on the duration and treatment~     received while in their parent study. Safety assessments (physical examinations, vital sign~     measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition~     scans, clinical laboratory assessments and monitoring of adverse events) will be evaluated~     during this study. Disease assessment will be performed using local standard of care imaging~     practices and criteria appropriate for disease type and location.~   "
116384|NCT01531881|"~     This research may help dentists or surgeons to better detect areas in the mouth that are~     either prone to cancer or are early cancers. The earlier the detection on cancer in the~     mouth, the better the chance that treatment or prevention can be more effective.~   "
116385|NCT01531868|"~     Background: In a previous study, information verbally presented as relative risk (e.g. 50%~     less likely) or qualitative risk (e.g. significantly less likely) resulted in many more~     people (66%) choosing a surgical procedure for narrowing or artery in the neck than people~     presented with absolute risk (e.g. 11% versus 5% over 5 years), annualized risk (e.g. 2%~     versus 1% per year for 5 years) and event-free survival (e.g. 95% versus 89% over 5~     years) (33%).~      Objectives: The purpose of this study is to determine whether the same observations are true~     for information that is presented visually as a bar graph. In addition, the investigators~     also seek to determine whether subjects feel that they understand the information better~     when presented visually as compared with verbally.~      Methods: 450 subjects will be approached in the neurology clinic as they are waiting for~     their office visit. If the subject agrees to participate in this 10 minute study, they will~     be taken to a quiet room where they will watch a 1 minute video on a laptop. The video will~     feature an acting physician. The presenter will be the same for all experiment groups. The~     presenter will describe a hypothetical medical situation in which a narrowing of one of the~     carotid (neck) arteries is present. The presenter will then describe the risk of a stroke~     related to that condition if the subject chooses medical therapy versus medical and surgical~     therapy. The presentation of risk will vary and may be presented in one of 3 different ways~     including a qualitative description, an absolute risk reduction over a fixed time period,~     and a relative risk reduction. These three risk groups will be presented either verbally or~     visually through bar graphs. In the visual subject groups, the presenter will be holding up~     a graph and remain silent while the graph is shown. The amount of time allotted for the~     graph on the video will be equal to the amount of time it takes the presenter to say the~     information in the auditory subject groups. Given that there will be 2 sensory modalities~     (verbal of visual) and 3 different presentation formats, there will be a total of 6~     different videos. After the video is complete, the subject will be asked to complete a 1~     page survey which will ask about the patient's age, gender, educational level, reason for~     the medical visit, and final decision about choice of treatment. The subjects will also~     answer how well they understood the data by making a mark on a 10 cm horizontal line.~   "
116386|NCT01531855|"~     The investigators hypothesise that reducing rapid-acting insulin dose after exercise will~     help prevent Type 1 diabetes individuals experiencing hypoglycaemia.~   "
116387|NCT01531842|"~     This is a research study to evaluate the effects of repeated intravitreal injections on~     bacteria around the eye.~   "
116388|NCT01531829|"~     In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant~     tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding~     tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is~     worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can~     rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse~     events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with~     acute normotensive PE with right ventricular dysfunction(RVD).~   "
116389|NCT01531816|"~     Critically ill patients are often confined to bedrest, because of the nature of their~     illness. However, it has now been shown that prolonged bedrest and immobility, particularly~     in critically ill adults and children, can lead to serious outcomes such as muscle weakness~     and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated~     that preventing immobility and introducing exercise and rehabilitation in adult patients~     early during their ICU illness can prevent these serious outcomes, reduce the duration of~     hospital stay, and enhance their recovery after they leave the ICU. The purpose of our~     research is to investigate if early mobilization and rehabilitation can also be performed in~     critically ill children, and eventually evaluate this results in beneficial outcomes in~     these children, as it has been shown to be in adults. However, given that children are not~     the same as adults, but have varying abilities to understand and participate in activities~     when they are sick, the investigators first have to evaluate the most appropriate and safe~     ways of helping children exercise while they are in the ICU. This objective of this study~     is to evaluate if 2 methods of rehabilitation (a stationary bike and interactive video game)~     can be implemented in critically ill children. These methods have been used in hospitalized~     children and in critically ill adults. The investigators will evaluate if these methods are~     safe for critically ill children.~   "
116390|NCT01531803|"~     This is a randomized, controlled, open-label clinical trial to be conducted at approximately~     12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of~     22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and~     30 days of treatment/follow-up period, and 3 months for study close-out.~      The study population will consist of at least 60 male and female pediatric subjects between~     0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery~     with an approximately equal number of subjects (n=10 to 25) in three of the four age groups:~     (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.~      Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be~     enrolled in the study will not be predefined as very a small number of elective surgical~     procedures is expected in this population.~      Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored~     annually (starting from the enrollment of the 60th subject) by an independent Safety~     Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to~     the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the~     threshold for acceptable safety will also be set.~      During the conduct of the study on the first 60 patients, if there is any safety signal~     linked to the primary safety endpoint (i.e. pulmonary fluid overload) or imbalance in the~     incidence of AEs between the treatment and control groups or based on relevant literature,~     as judged by the SMB, the enrolment will be increased to 100 patients using the same age~     stratification approach defined above (n=20 to 30 in each age group).~      Potential subjects will be pre-screened and informed consent/assent will be obtained from~     the subject and/or subject's parents or guardians prior to surgery. Post-surgery, the~     subject will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit~     (SICU/NICU/PICU) for postoperative recovery and care management. Subjects who show signs of~     hypovolemia as judged by the Principal Investigator (PI) will be screened to determine their~     eligibility to participate in this trial. Subjects will then be randomized to receive~     treatment with Kedbumin 25% or the comparator, normal saline (sodium chloride 0.9%).~      There is no specific post-treatment regimen for this protocol, as all subjects will receive~     the standard post-operative care based on their clinical status and response to treatment at~     the discretion of the Investigator.~      Vital signs and fluid management/replacement therapy recorded in the medical chart and~     results of standard complete blood count (CBC), biochemistry, and hematology and coagulation~     lab panels will be reviewed and recorded by research staff at specified time points,~     according to the hospital standard of care. Additionally, research staff will review and~     record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive~     measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr~     post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability~     will be evaluated based on site-specific age-defined reference ranges for heart rate, blood~     pressure, urine output, and cardiac index in children.~      The volume, rate and frequency of the Investigational Medicinal Product (IMP, either~     Kedbumin 25% or normal saline) administered will be recorded in addition to the type,~     timing, and amount of all other fluids administered. The time to hemodynamic stability,~     duration of stability once attained, and any relapse requiring additional treatment or use~     of secondary resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic~     stability within 3 days after treatment initiation and then relapse into hemodynamic~     instability as a result of surgical complications or infection will exit from the study, but~     the data be considered for the safety analysis. These subjects should continue treatment~     according the clinical practice standard since the study is not intended to evaluate the~     efficacy of Kedbumin 25%.~   "
116391|NCT01531790|"~     This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics~     of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in~     advanced non small cell lung cancer (NSCLC) patients.~   "
116392|NCT01531777|"~     RATIONALE:~      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.~     The investigators' phase I study has shown that the drug's toxicity is manageable.~      PURPOSE:~        1. Studying how well Apatinib works in treating patients.~        2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.~        3. Pharmacokinetics/Pharmacodynamics(PK/PD).~        4. Exploring new outcome measures of antiangiogenic drugs.~   "
116435|NCT01532193|"~     This study will determine whether the use of low oxygen tension during in vitro embryo~     culture may increase the pregnancy rates in women undergoing egg donation.~   "
116436|NCT01532180|"~     The objective of the study is to determine the safety and preliminary efficacy in patients~     utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).~   "
116393|NCT01531764|"~     This open-label, single-arm, multicentre phase II trial will be performed in patients with~     intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and~     one first-line therapy in the metastatic setting.~      The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in~     combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial~     shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination~     with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are~     warranted.~      Patients will be followed until progression. After progression, for the purpose of analysing~     overall survival, information on vital status and subsequent treatment will be collected.~      The primary objective is to determine the 6-month progression free survival rate of BIBW~     2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative~     breast cancer.~      BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the~     hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by~     immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit~     from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible~     EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.~   "
116394|NCT01531751|"~     The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis~     treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.~   "
116395|NCT01532739|"~     The purpose of this study is to investigate the feasibility and effectiveness of a cognitive~     training group in individuals with Mild Cognitive Impairment, using a new paradigm that will~     optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing~     traditional memory training with the teaching of an empirically-supported problem-solving~     approach, and (3) employing a clinically representative sample of individuals with MCI~     (e.g., not excluding those with mild affective symptoms).~   "
116396|NCT01532726|"~     This is a multicenter, non-interventional, prospective study. The observation period~     comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients~     with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit~     that occurs between 6 and 9 months of follow-up. The observation period will end after 9~     months of follow-up even if the final assessment is not performed.~   "
116397|NCT01532713|"~     Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the~     stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows~     continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation~     (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the~     baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with~     cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow~     in the non-block side. The investigators researched the effect of oxygen administration on~     rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was~     supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were~     measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.~      The present study suggests that oxygen administration can increase the rSO2 of non-block~     side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with~     cerebral vascular disease during SGB.~   "
116398|NCT01532700|"~     This is a phase 2, open-label, single institution trial of combination of intravenous (IV)~     ofatumumab and oral GSK2110183 in patients with relapsed or refractory Chronic Lymphocytic~     Leukemia (CLL). Patients must have received at least one prior line of therapy containing~     fludarabine (single-agent or combination therapy). During the initial 6 months Treatment~     Phase, ofatumumab will be administered weekly for 8 doses, then once every 4 week cycle for~     an additional 4 doses (dose and schedule identical to the pivotal phase 2 trial) and~     GSK2110183 will be given daily PO (Treatment Phase). There will be an initial 10 day lead-in~     with GSK2110183 alone prior to initiation of ofatumumab to allow for evaluation of changes~     in cell surface expression due to GSK2110183 and for GSK2110183 pharmacokinetic studies~     (Lead-in Phase). The official Cycle 1 Day 1 will start on the date of first dose of~     ofatumumab. Cycle duration = 4 weeks. Patients will be assessed for safety, disease~     assessment, response, and survival on day 1 of each cycle during the Treatment Phase. A~     formal review of safety data by the Data Safety Monitoring Board (DSMB) after the first 6~     patients have completed cycle 1 of the Treatment Phase will be performed before continuing~     accrual. All patients achieving SD, PR or CR by the end of the Treatment Phase will proceed~     to the Maintenance Phase. Patients with PD at any time, including by the end of Treatment~     Phase, will be taken off study. During the Maintenance Phase, single-agent GSK2110183 will~     be administered daily for a maximum of 12 months (12 cycles). Maximum duration on any study~     drug is 18 months (18 cycles). During the Follow-up Phase, patients will be assessed for~     safety, disease assessment, response, and survival every 3 months through month 36 (year 3),~     or until subsequent CLL therapy or death, whichever comes first. Key indications for study~     withdrawal are progressive disease, intolerable toxicity, or completion of therapy~   "
116399|NCT01532687|"~     This randomized phase II trial studies how well gemcitabine hydrochloride works with or~     without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor~     cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine~     hydrochloride is more effective with or without pazopanib hydrochloride in treating patients~     with soft tissue sarcoma.~   "
116400|NCT01532674|"~     The goal of this study is to determine if patients with chronic periodontitis when~     undergoing with scaling and root planing (SRP) plus photodynamic therapy in comparison with~     SRP alone result in improved clinical, microbiological and biochemical outcomes.~   "
116401|NCT01532661|"~     The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not~     been proven yet in this context. A national register has been set up in France identifying~     the patients which received rFVIIa.~      Those patients had persistent and active bleeding after severe trauma despite surgery and/or~     interventional radiology embolization.~      The aim of this present study is to report the first clinical results in those situations of~     patients treated with rFVIIa.~   "
116402|NCT01532648|"~     This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as~     add-on therapy to an existing oral 5-ASA regimen for the induction of remission in patients~     with active, mild or moderate ulcerative colitis (UC).~   "
116437|NCT01532167|"~     The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than~     clinical and laboratory values for the identification and assessment of inflammatory~     activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a~     precise evaluation of response to therapy.~   "
116403|NCT01532635|"~     This phase II clinical trial studies how well two donors stem cell transplant work in~     treating patients with high-risk hematologic malignancies. After receiving radiation to help~     further treat the disease, patients receive a dose of donors' T cells. T cells can fight~     infection and react against cancer cells. Two days after donors' T cells are given, patients~     receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue~     damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not~     destroyed by CY and they remain in the patient to help fight infection. A few days after the~     CY is given, patients receive donors' stem cells to help their blood counts recover. Using~     two donors' stem cell transplant instead of one donor may be more effective in treating~     patients with high-risk disease and may prevent the disease from coming back.~   "
116404|NCT01532622|"~     The purpose of this study is to determine the impact of blueberries on uric acid in patients~     with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis~     the investigators propose is that daily blueberries added to a pre-existing diet will~     promote uric acid lowering and improve quality of life without detriment to vital signs.~   "
116405|NCT01532609|"~     This study is an intervention pilot that integrates the current methadone maintenance~     treatment (MMT) program in China with psychosocial and behavioral components in order to~     address the critical link between drug use and HIV/AIDS.~      The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed~     the intervention manuals and supporting materials, and finalized assessment measures and~     implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT~     clinics involving 41 service providers and 179 clients, and followed up at three, six, and~     nine months.~   "
116406|NCT01532596|"~     The purpose of this study is to test if an 8-week mindfulness meditation training (vs a~     wait-list control condition) program reduces neurobehavioral reactivity and improves affect~     regulation in a sample of older adults, as measured by functional magnetic resonance~     imaging. Additionally, we will examine if mindfulness meditation training reduces loneliness~     and markers of chronic inflammation.~   "
116407|NCT01532583|"~     The aim of our study is to report the subjective and objective outcome of outside-in~     transobturator technique (TOT) (Monarc®) in long-term follow-up.~      This is a follow-up study concerning 191 patients operated on in Turku University Hospital~     between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress~     test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score~     (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a~     supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale~     (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and~     short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an~     absence of reoperation for SUI during the follow-up period.~   "
116408|NCT01532570|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of~     TA-650 in patients with Behcet's disease ( BD ) with special lesions after the~     administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks~     after week 14 up to week 46.~   "
116409|NCT01532544|"~     This is an investigator sponsored double-blinded, multinational, multi center, randomized~     (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with~     severe sepsis or septic shock, investigating the safety and efficacy of co-administration of~     Iloprost and escalating doses of Eptifibatide for continuous intravenous infusion in totally~     36 patients.~   "
116410|NCT01532531|"~     Collateral meridian therapy (CMT) is a recently developed technique according to traditional~     Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in~     numerous manners. CMT involves the manipulation of a distant non-painful collateral~     meridian, thereby facilitating the dissipation of pain. The technique avoids direct~     stimulation of the involved meridian, which enhances patient tolerability and prevents~     further injury to the disease and painful areas. Numerous clinical cases have reported the~     effectiveness of CMT in pain management. This study tests whether CMT is effective for~     treating knee OA pain and functional recovery.~   "
116411|NCT01532518|"~     The present pilot study is aimed to obtain preliminary data on the effect of three ascending~     oral dose levels of nepadutant on the relief of symptoms associated with feeding~     intolerance. In addition, the assessment of drug exposure (PK assessment) will provide~     additional information on the dose-effect relationship, thus supporting the dose selection~     and dosing schedule in the future studies.~   "
116412|NCT01532505|"~     The objective of this research is to compare the effect of a low dose Vasopressin infusion~     or placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and~     tissue oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in~     elective on pump cardiac surgery patients using a non-invasive near infrared spectrometry~     (NIRS) machine. The clinical implications are that NIRS may permit earlier, non-invasive~     detection of significant physiologic derangements and allow more accurate and timely~     titration of medications, fluids and surgical intervention. The use of a low dose~     vasopressin seems to be preventive for the incidence of observed post-cardiotomy~     vasodilatory shock and may improve the function of microcirculation that will be assessed~     using VOT and tNIRS. Finally, it may decrease both catecholamine dose and duration of their~     administration, it is considered as a useful agent for decreasing all heir side-effects~   "
116413|NCT01532492|"~     Arthroscopic rotator cuff repair is described as being a successful procedure. These results~     are often derived from clinical general shoulder examinations, which are then classified as~     'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications~     vary and sometimes modified scores are used.~      Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease~     specific health-related quality of life patient-administered questionnaires are needed. The~     WORC is a quality of life questionnaire designed for patients with disorders of the rotator~     cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair~     specifically.~      The aim of this study is to investigate reliability, validity and responsiveness of WORC in~     patients undergoing arthroscopic rotator cuff repair.~   "
116438|NCT01532154|"~     This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with~     multiple sclerosis who have been exposed to prolonged-release fampridine since the first day~     of their last menstrual period prior to conception or at any time during pregnancy.~   "
116414|NCT01532479|"~     The purpose of this study is to determine if Hyperbaric Oxygen (HBO) therapy improves~     salivary gland function in previously head-and-neck irradiated patients. The following will~     be evaluated: salivary a-amylase, IGF-1, Thrombospondin-1, and VEGF-A concentrations,~     resting and stimulated salivary flow rate and pH, and salivary buffering capacity.~     Demographic data, past medical/surgical histories, social history and habits, risk factors,~     medication list, nutritional status, stage and location of tumor treated, dose/duration of~     radiation, and time elapsed since radiation treatment will be reviewed and recorded.~     Subjects will complete a quality of life questionnaire, describe (presence/absence) dry~     mouth symptoms prior to HBO therapy, and provide current A1c level, or submit to a finger~     stick. The following groups will be evaluated: 1. Head-and-neck irradiated subjects with ORN~     (indicating HBO therapy) 2. Subjects with other conditions indicating HBO therapy (positive~     control), and 3. Head-and-neck irradiated subjects without ORN (negative control). Subjects~     will include 78 males or females, 18 years old and over. In total, participation will last~     22 weeks.~   "
116415|NCT01532466|"~     An intravenous bolus of fentanyl often induces a cough reflex. This study investigates~     whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.~   "
116416|NCT01532453|"~     The purpose of this trial is to investigate the prevention of actinic keratoses and squamous~     cell carcinomas by local application of MD-3511356 in comparison to standard sun protection~     measures in immunosuppressed solid organ transplant recipients.~   "
116417|NCT01532427|"~     This is a post market surveillance registry to monitor the safety and performance of the~     ALFApump system.~   "
116418|NCT01532414|"~     The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and~     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism~     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with~     placebo. Subjects must not have previously been treated with testosterone products within~     the last 6 months.~   "
116419|NCT01532401|"~     The primary objective of this study is to analyze the sensitivity of blood pressure to oral~     salt intake. Matched male and female participants will be selected as normal weight,~     overweight, and obese.~      Participating subjects will have a first visit with blood pressure measurement and a blood~     sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6~     grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.~   "
116420|NCT01532388|"~     Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled~     design, measuring outcomes in terms of changes in problematic drug use up to one year after~     study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug~     use offers self-screening, in-depth self-reporting, personalized feedback and treatment~     recommendations as well as an electronic diary. Progress over time is shown in diagrams~     detailing consumption levels.~      Method: Participants with only problematic drug use according to the Drug Use Disorders~     Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol~     use according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men~     and AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group~     (n=101). Outcomes on alcohol and/or drug use as well as health-related symptoms were~     assessed after 3, 6 and 12 months.~      Hypotheses that were tested in this study are 1) that both groups would reduce their drug~     consumption and drug-related problems at follow-ups compared to the baseline level and 2)~     that participants in the eScreen group would reduce their drug consumption and drug-related~     problems to a higher extent than participants in the control group (no intervention) at~     follow-ups.~   "
116421|NCT01532375|"~     With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be~     potentially effective in preventing and treating obesity and cardiovascular risks if proven~     in humans. However, human trial still have not been reported with KCJ supplementation. In~     the present study, we investigated the hypothesis that KCJ supplementation can be decrease~     the body fat and improve blood lipid profiles in overweight adults.~   "
116422|NCT01532362|"~     The primary objective for this trial is to determine the biological ability of apricoxib to~     decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects~     compared to those who have not in subjects with early stage Non-small Cell Lung Cancer~     (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit~     CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of~     apoptosis resistance, angiogenesis, invasion, and immunity.~   "
116423|NCT01532349|"~     This research is being done to study the effectiveness of vitamin D (cholecalciferol) to~     modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common~     problem in children with CKD. Anemia is when the body does not have enough healthy red blood~     cells. Hepcidin is a protein in the blood which interferes with the body's production of red~     blood cells. This study will see if vitamin D lowers hepcidin levels in children and young~     adults with CKD. If so, it could be used as an additional treatment for anemia in these~     children, in addition to the current therapies already in use including iron supplements and~     erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this~     study.~   "
116424|NCT01532336|"~     The purpose of this study is to evaluate the clinical and microbiological efficacy and~     safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one~     year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based~     upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen~     Screening, Inc).~      Subjects will be randomly assigned to receive either NVC-422 or Vehicle.~   "
116439|NCT01532141|"~     The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067~     pharmacokinetics in healthy subjects.~   "
116440|NCT01532128|"~     The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline~     pharmacokinetics in healthy subjects.~   "
116441|NCT01532115|"~     The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac~     repolarization in adult healthy men and women volunteers.~   "
116442|NCT01532102|"~     The purpose of this study is to determine the safety, tolerability and efficacy of the~     topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human~     papillomavirus (HPV).~   "
117333|NCT01520220|"~     The purpose of this study is to determine a dose of LY2784544 that may be safely~     administered to participants with myeloproliferative neoplasms.~   "
116425|NCT01532323|"~     In Human, the oral sphere is the first and main place where sensory stimuli are received and~     perceived. The phenomena occuring during food breakdown and sensory perception are complex~     and in this system saliva plays a major role.~      In the neonatal period, severe digestive diseases require the cessation of all oral feeding~     and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth~     and development of children while their disease is active. The early stages of sensory oral~     exposures and their consequences on the development of eating habits of these children are~     poorly documented. It is likely that the process of acquisition of preferences and eating~     habits is atypical because of a bypass of the oral sphere during the early stages of~     feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes~     and textures in the first year of life, which may impact on their oral acceptance at a later~     age. These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a~     refusal of certain consistencies and difficulties in chewing and swallowing. Few data are~     available on food typically accepted by these children.~      Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been~     described yet. It is likely that they may differ significantly from those of healthy (NOD).~      In this context, a population of OD children is particularly interesting for studying the~     effects of the absence of these learning stages and their consequences in the development of~     sensory perception and eating habits.~      The investigators formulate the hypothesis that the lack of exposure to a standard oral diet~     would modify the development of their oro-sensory systems including saliva.~      Studying such a population is a great opportunity to assess the influence of non oral food~     exposures and diet on saliva characteristics.~      Saliva has recently received attention as a potential easy to collect source of biomarkers~     in several conditions excluding OD.~      The potential impact of OD on salivary composition has never been studied. Several studies~     linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité~     Mixte de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already~     contributed to highlight the great inter-individual variability for a number of saliva~     markers and a change in saliva protein profiles in response to taste stimulation They also~     underlined the remarkable intra-stability for saliva flow and composition during a one year~     study.~      This study intends to prove the concept that it is relevant to relate saliva characteristics~     to food intake behaviour or food habits The first hypothesis to be tested in this study is~     that salivary profiles (biological signatures) can discriminate two groups of children~     differing by their orality.~      The second hypothesis to be tested is that these specific biological biological signatures~     may be correlated to certain food habits associated or not with oral disorders.~   "
116426|NCT01532310|"~     This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and~     pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who~     have received commercially supplied belimumab within the 4 months prior to and/or during~     pregnancy. The registry will also evaluate outcomes of infants born to mothers who were~     exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry~     will add to the current clinical experience with belimumab and will complement reproductive~     data from animal toxicology studies. It will also assist clinicians in weighing the~     potential risks against the benefits of treatment for individual patients with SLE.~     GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it~     holds Marketing Authorization.~   "
116427|NCT01532297|"~     Study investigating the safety and efficacy of the citrate dialysis solution compared to~     standard acetate dialysis solution. Use of citrate dialysis solution is not associated with~     a clinically relevant development of adverse events. It is hypothesized that citrate~     dialysate may provide a local anticoagulation effect in the dialyser improving removal of~     uremic toxins.~   "
116428|NCT01532284|"~     A pragmatic, multicentre, randomized double-blind controlled trial with an~     intention-to-treat analysis, of the use of preimplantation genetic screening (PGS) for~     aneuploidy by means of microarray comparative genomic hybridization (CGH) for the~     chromosomal analysis of the polar bodies (PB) of oocytes collected after ovarian stimulation~     for in vitro fertilization (IVF), and with the intention to assess the genetic competence of~     oocytes of advanced biological age, and the effect of this technique on reproductive~     outcome.~   "
116429|NCT01532271|"~     The use of Event Related Potentials (ERP) and neurocognitive performance in patients~     following concussion has been examined previously in small cohorts and relatively long after~     concussion occurred. However, little is known about the immediate changes in brain activity~     in specific brain regions and connectivity across them associated with performance on~     specific neurocognitive tests following a concussion, and the subsequent changes over time.~     The proposed study will provide initial evidence for the feasibility of an ERP based~     biomarker for concussion reflecting temporal and spatial changes in brain activity as well~     as brain functional connectivity associated with concussion.~   "
116430|NCT01532258|"~     This research is examining whether an 8-week online nutritional programming based on a~     Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and~     improvements in measures of body weight and laboratory measures of oxidative stress, a risk~     marker for cardiovascular disease. This study will also examine whether weekly short support~     and communication from a medical assistant (MA) in a primary care setting in addition to the~     online program will result in better program adherence and have a positive impact on health.~   "
116431|NCT01532245|"~     One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is~     application of PEEP to the dependent lung. However, only a minority of patients benefit from~     this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the~     total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve~     (1). LIP during OLV can be determined with super-syringe technique, but is too complicated~     for routine operating room use. An alternative is the constant-flow method which is easy and~     widely used in intensive care settings (2). The investigators goal was to confirm that the~     constant-flow method as applied by an intensive care ventilator works during OLV.~      Methods: After IRB approval and written, informed consent, data were obtained from 20~     patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS~     Healthcare) critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1~     tidal volume was used. During OLV, ventilation periods of ten minutes, with and without 5~     cmH2O PEEP were alternated. During each period, the investigators recorded arterial blood~     partial pressures, respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP.~     PEEPi and LIP were determined using the automatic mode of the ventilator; specifically, LIP~     was determined with a continuous flow of 3L/minute.~   "
116432|NCT01532232|"~     Breast cancer patients who smoke, are at greater risk for treatment complications. The~     purpose of this study is to see if the researchers can find ways to help patients who have~     breast cancer quit smoking. They will compare two ways to help people quit smoking. Some~     patients will receive varenicline, a prescription medicine also known as Chantix,®. Other~     patients will receive a placebo drug. A placebo is an inactive substance that contains no~     medicine. All patients will receive smoking cessation counseling provided by our tobacco~     treatment specialists. They hope that what the researchers learn from this study will help~     us improve our smoking cessation treatment program for breast cancer patients.~   "
116433|NCT01532219|"~     The overall aim of this study is to develop and test a psychodynamic Internet-delivered~     psychological treatment for patients with major depression and/or anxiety disorders and~     compare its efficacy to an active control group.~   "
116443|NCT01532089|"~     This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or~     without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung~     cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different~     ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking~     the growth of new blood vessels necessary for tumor growth. It is not yet known whether~     erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating~     patients with NSCLC.~   "
116444|NCT01532076|"~     Failure rates of up to 30% are reported after proximal humeral fractures despite~     angular-stable devices. This may devastate not only the functional outcome but also the~     independence of elderly patients.~      To increase bone mineral density and thereby holding-strength augmentation is an option.~     Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis~     since osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose~     tissue seems an alternative cell-source even in presence of osteoporosis.~      Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and~     vasculogenic potential and can be harvested in high numbers. Expansion associated with~     costly good-manufacturers-practice facilities is avoidable, so are repeated interventions.~     These cells have been successfully used to generate osteogenic composite grafts with~     intrinsic vascularity in preclinical models.~      For translation into clinical practice after a 20 patient external pilot a prospective~     randomized controlled trial with 270 patients is planned. For the trial lipoaspiration~     precedes open reduction and internal fixation in individuals over 60 years presenting with a~     proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS)~     and wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for~     augmentation of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks~     for immediate complications and after 6, 9 and 12 months. Functional assessment is performed~     after 6 weeks, 6 and 12 months using the Quick-Dash- and Constant-Score.~      The primary outcome is a reduction in secondary dislocation by 50% during the first~     postoperative year. Secondary dislocation is diagnosed on plain radiographs by an~     independent board certified radiologist specialised in musculoskeletal imaging if one or~     more of the following criteria are met:~        -  More than 20° varus collapse of the humeral head fragment in relation to the humeral~          shaft~        -  Screw penetration through the humeral head~   "
116445|NCT01532063|"~     Difficult intubation is challenging in intensive care units. There are limited data~     regarding risk factors of difficult intubation in ICU. The primary purpose of the~     investigators study is to assess the risk factors of difficult airway in adults in ICU.~   "
116446|NCT01532050|"~     The present research intends to focus clinically on selecting the right type of patient for~     mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging~     and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy~     techniques with simulation of the mandibular repositioning. The core of the research project~     relies on known and established methods accepted in several neighboring fields, but aims at~     the transfer of this knowledge by integrating it into this new domain. Doing so, the~     proposed biomedical research is directed towards clinical applications that incorporate~     innovative developments on the level of the diagnosis and therapy of a specific disease,~     being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering~     objective compliance during MAD therapy.~   "
116447|NCT01532037|"~     The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self~     help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).~   "
116448|NCT01532024|"~     Seriously ill patients may develop a complication called acute lung injury (ALI), a form of~     inflammation in which lung tissue is filled by fluid containing white blood cells called~     neutrophils. ALI is common and is often fatal (for example in the USA it is estimated that~     190,000 patients develop ALI per annum, of whom 75,000 die). No pharmacological treatment~     has been shown to improve ALI.~      Data from animal models and patients strongly suggest that neutrophils are central to~     disease progression. However no bedside methods exist to rapidly and accurately determine in~     seriously ill patients, if neutrophils are present and if they are releasing damaging~     enzymes such as elastase. As such, the investigating team have developed and synthesised to~     clinical grade, an imaging agent called NAP (Neutrophil Activation Probe) that detects~     activated neutrophils and also the damaging enzyme, human neutrophil elastase (HNE). The~     investigators have extensively tested NAP in animal models for efficacy and safety. It~     reliably detects activated neutrophils and is not toxic.~      NAP is a small molecule that is delivered in tiny doses (called microdoses) to areas of~     inflammation in human lungs through a bronchoscope. The activity of NAP is visualised by~     imaging though a tiny camera that is also introduced through the bronchoscope. This camera~     system is now widely used throughout the world in over 150 sites.~      The investigators therefore aim to test the utility and safety of NAP in an exploratory~     clinical study. The study involves the delivery of NAP to 6 healthy volunteers followed by~     delivering NAP to 3 patients in ICU with pulmonary infiltrates and 6 patients known to have~     bronchiectasis.~      In the healthy volunteers study, healthy male volunteers recruited from the University of~     Edinburgh will be invited to participate.~      In the ICU study, patients will be recruited from the ICU in the Royal Infirmary of~     Edinburgh.~      In the bronchiectasis study, patients will be recruited from the respiratory service in NHS~     Lothian.~      If the study (which is supported by the Medical Research Council) demonstrates safety and~     also the ability to image activated neutrophils, the investigators intention is to design~     future studies in patients with ALI.~   "
116449|NCT01532011|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of erlotinib and pralatrexate that can be given to patients with advanced~     cancer. The safety of the drug combination will also be studied.~      Pralatrexate is designed to block the body's ability to make folic acid, a protein that may~     help cancer tissue to develop and spread.~      Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells~     to grow. Erlotinib may help slow the growth of tumors.~   "
116450|NCT01531998|"~     The goal of this clinical research study is to find the highest tolerable dose of Siltuximab~     that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and~     dexamethasone to patients with MM. The safety of this drug combination will also be studied.~   "
116451|NCT01531985|"~     The purpose of this study is to find out whether a combination of new urine tests and blood~     tests can show kidney injury in its early stages, before kidney failure sets in. If the~     investigators find new tests that show kidney injury in early stages, the investigators hope~     to start treating people with kidney injury earlier, to prevent kidney failure. You/your~     child are at higher risk for kidney injury and kidney failure than most other people,~     because of having operations with cardiopulmonary bypass (a machine that pumps your/your~     child's blood during the operation). This research is being done because there are no tests~     yet proven to show kidney injury before it leads to kidney failure.~      The urine and blood tests the investigators are studying have each been shown to indicate~     some degree of kidney injury in certain people, but not with the accuracy needed to diagnose~     disease. The investigators think that the combination of urine and blood tests being tried~     in this research study may provide enough information to better diagnose kidney injury at an~     earlier stage.~      About 20 persons over 2 years old up to adults will take part in this study. All will be~     from the Herma Heart Center of Children's Hospital of Wisconsin.~   "
116454|NCT01531946|"~     The purpose of this study is to detect acute ischemic lesions in patients admitted with~     symptoms of transient ischemic attack (TIA).~      Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions~     after TIA. The problem is that this only gives the diagnosis in 30% of the cases.~      It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and~     diffusion tensor imaging will make it possible to give a more accurate diagnosis.~   "
116455|NCT01531738|"~     The investigators hypothesize that some of these changes in the reduced appetite after~     surgery may be due to alterations in taste. The aim is to compare obese patients before and~     after bariatric surgery (gastric bypass and banding) to define the reward value of sweet,~     fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.~   "
116456|NCT01531725|"~     The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK~     PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary~     arteries.~   "
116457|NCT01531712|"~     Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed~     by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with~     borderline resectability. The primary objective is to determine the resectability rate of~     patients with pancreas adenocarcinoma with borderline resectability determined~     radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy~     with Gemcitabine and Tarceva.~   "
116458|NCT01531699|"~     This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess~     the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal~     administration in healthy volunteers. Efficacy will be assessed by comparing the reduction~     in microbial load for up to 6 hours to that of saline control.~   "
116459|NCT01531686|"~     Intraosseous vascular access can be used to effectively and safely deliver contrast dye for~     CT examination.~   "
116460|NCT01531673|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and~     pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in~     subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation.~   "
116461|NCT01531660|"~     Background: Inactive individuals face motivational obstacles for becoming and staying~     physically active. Therefore, sustainable physical activity promotion programs tailored to~     reach inactive individuals are needed.~      Purpose: to test the effect (long and short-term) and feasibility of a training program and~     to evaluate the association between the baseline motivation to become physical activity and~     the change in physical activity and performance.~      Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and~     older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main~     outcome measures: physical performance and level of physical activity~   "
116462|NCT01531647|"~     This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug~     interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.~     Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,~     danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days~     18-21.~   "
116463|NCT01531634|"~     The field of psychiatric rehabilitation focuses on creating a personal narrative and~     developing coping strategies and environmental supports. The concept of recovery is~     person-centered and emphasizes the person's ability to change and to live meaningful life.~     The strengths approach has a central role in the recovery concept, emphasizing the person's~     abilities and potential. A preserved cognitive ability can be a significant strength in the~     recovery process.~      Research had shown growing support for the use of cognitive-behavioral approaches as the~     most effective therapy for people with borderline personality disorder, using structured~     interventions. A central focus in cognitive therapy is the change of maladaptive schemes.~     The dynamic-cognitive intervention (DCI) is based on the understanding of structural~     cognitive modifiability and suggests the use of mediated learning in order to enhance sense~     of competence and develop better psychological coping skills.~      The present study will focus on women diagnosed with borderline personality disorder, with~     normative cognitive ability seen as a strength as opposed to their emotional ability. This~     study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and~     on symptoms severity.~      The study will include 30 women aged 18-45 years. Participants will be randomly assigned to~     an intervention group and a control group. All participants will be assessed before and~     after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom~     Inventory.~      The intervention designed for this study is based on the principles of the Dynamic Cognitive~     Intervention. The intervention tools that will be used include: a. Instrumental Enrichment~     tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The~     intervention encompasses 12 sessions of 1.5 hours, with a routine structure.~      The results are expected to contribute to the understanding of the impact of a dynamic~     cognitive intervention in women diagnosed with borderline personality disorder.~   "
116464|NCT01531621|"~     -  A population-based prospective study to evaluate clinical behaviour, resectability and~          survival in 1st line metastatic colorectal cancer (CRC) patients in Finland~        -  Primary objective: To assess clinical behaviour of metastatic colorectal cancer and~          overall resectability, postoperative morbidity and outcomes after resection~        -  Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy~          and targeted drugs with overall response rates (ORR), failure free survival (FFS),~          progression free survival (PFS), and overall survival (OS); To radiologically assess~          tumour density and morphology, and assess alternative radiologic response evaluation in~          comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and~          tumour block biomarkers and DNA polymorphisms that may predict drug effects,~          resectability and clinical behaviour of the tumour~   "
116465|NCT01531608|"~     This is a single-institution study seeking to evaluate if mobile gamma camera imaging can be~     used independent of standard fixed gamma camera imaging in patients undergoing sentinel node~     biopsy for melanoma.~   "
116466|NCT01531595|"~     -  Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with~          alternating Xeliri and Xelox as first-line treatment of patients with metastatic~          colorectal cancer.~        -  Primary objective: PFS, To assess overall resectability in patients with metastatic~          colorectal cancer, postoperative morbidity and outcomes after resection.~        -  Secondary objectives: To assess response rates according to RECIST criteria, failure~          free survival (TTF) and overall survival (OS), Quality of life according to 15D~          questionnaire, To radiologically assess tumour density and morphology, and assess~          alternative radiologic response evaluation in comparison with RECIST response criteria,~          Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms~          that may predict drug effects, safety, resectability and clinical behaviour of the~          tumour~   "
116529|NCT01530763|"~     This is a study of safety and effectiveness of ceftaroline fosamil in children with~     Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.~   "
116467|NCT01531582|"~     There is mounting evidence to suggest that a treatment for Angelman syndrome is not just~     possible, but probable. The lack of known molecular targets associated with AS has hampered~     the development of specific therapeutics. However, a recent surge of potential therapeutics~     for other disorders associated with cognitive disruption has begun to be used in human~     clinical trials. The molecular modes of action for many of these new therapeutic agents have~     correlates to counter the molecular defects observed in AS. One such agent is minocycline~     (MC), a drug traditionally used as an antibiotic. This compound administered to a mouse~     model of AS showed a significant decrease in motor deficit and an increase in long term~     potentiation. The investigators believe a similar result will be observed when minocycline~     is administered to the AS patient and may lead to the development of an effective AS~     therapeutic.~   "
116468|NCT01531569|"~     This study is being done to look at age differences in the way the investigators bodies~     break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is~     administered to research subjects in a product called BeneFlax, which a concentrated version~     of flax seed containing 38% SDG.~      It is known that as people age, their bodies undergo physical changes both on the outside~     and the inside. The aging process may change the way that the investigators bodies deal with~     compounds the investigators eat. As an important measure of safety, the investigators want~     to check for evidence whether there is a difference in break down of SDG between different~     age groups.~   "
116469|NCT01531556|"~     Honey available in New Zealand can contain the toxins tutin and hyenanchin. Tutin is~     produced by several plants native to New Zealand. Bees collect honeydew contaminated with~     tutin and hyenanchin for honey production.~      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand~     since the 1800s, with the most recent outbreak in 2008.~      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.~     This information will help the Food Standards Australia New Zealand (FSANZ) give guidance on~     acceptable levels of tutin and hyenanchin in honey.~      About 6 healthy men will each take a single dose of honey containing known concentrations of~     tutin and hyenanchin.~      This dose level is similar to what someone who eats a lot of honey would consume, if the~     honey contained the maximum level of tutin allowed under the Food Standards Code.~      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after~     dosing, and any side effects will be recorded.~   "
116470|NCT01531543|"~     The aim of the project was to optimalize the process in severe peritonitis which is~     generally inflicted with high mortality and morbidity with long term costly therapy. Therapy~     of severe intraabdominal infection consist of treatment of the infection site and following~     closure of the abdominal cavity with possibility of re-laparotomy and in treatment of~     complications when needed; or closure introduction of laparostomy with intention to control~     complications prevention however with risk of tertiary peritonitis. Modern process is~     laparostomy with active suction (VAC) method which reduces the risk of tertiary peritonitis.~     It efficacy is however approved especially in therapy of complications. Based on the~     investigators experiences the investigators use this method even in case of primary~     treatment of severe peritonitis which led to protocol processing (VAC in case of primary~     closure of the abdominal cavity; VAC exchange according to scoring system; secondary closure~     of the abdominal cavity or early coverage with collagen mesh). The aim of this project is to~     prove reduced mortality, morbidity and hospitalization length (cost reduction) in~     prospective randomized study in patients treated due to severe peritonitis using VAC method~     in comparison to classical approach (primary closure of the abdominal cavity; secondary~     solution of complications).~   "
116471|NCT01531530|"~     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral~     vaccine) is safe and effective in the prevention of Shigella infection.~   "
116472|NCT01531517|"~     Clinical Trial Phase III-b~      Study Sponsor:~      European Egyptian Pharmaceutical Industries~      Sample Size:~      120 patients (60 per arm)~      Study Population:~      Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed.~     Those patients will be recruited from patients attending the Diabetic foot Center at Faculty~     of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo~     University.~      Recruitment Period: 9 months~      Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the~     ulcer.~      Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment~     whichever comes first~   "
116473|NCT01531504|"~     Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites~   "
116474|NCT01531491|"~     Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the~     rate of propofol elimination from the brain and the blood will be increased and the patient~     will awake more quickly. There has been no study about the effects of hypercapnia. The~     investigators will evaluate hypercapnia's effects on the recovery time from propofol~     anesthesia.~   "
116475|NCT01531478|"~     Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of~     850 French persons has survived childhood cancer. However, the complications of~     chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality,~     which the literature estimates is at 14%. Regular care has a positive impact on the quality~     of life and health of adults who survived cancer during their childhoods. It aims to detect~     the potential long-lasting effects of cancer and to provide therapeutic education and~     psychological care. Thanks to cancer registries, several countries (USA, Canada, UK,~     Germany, the Netherlands) have developed long-term care structures which function with~     specially trained adult medicine practitioners. There are only two structures in France: the~     Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes~     (France), and the LEA program for the follow-up of children treated for leukemia in the~     PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended~     to other centers.~      The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they~     compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary~     trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They~     analyzed the correlation between patients' quality of life and the long-term medical effect~     of cancer and treatment, both recorded in patients' medical files and declared by patients.~     These young adults who survived pediatric cancer appear to suffer from and declare many~     complications, although this does not impact their global quality of life much. There is a~     negative correlation between the number of complications (observed or declared) and the~     global quality of life score, but only three types of complications play a significant role~     (motor function complications, auditory complications, and alopecia.) In addition, there is~     a significant mismatch between patients's perceived health (what they say they experience),~     and the information contained in their medical files. These young adults expressed the need~     for their impressions to be better taken into account by health care professionals. This~     study does not assess patients' psychopathological characteristics.~   "
116583|NCT01530048|"~     This trial is conducted in Europe. The aim of this trial is to test if there is~     bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin~     aspart 200 U/mL (U200) formulation.~   "
116476|NCT01531465|"~     The purpose of this study is to compare two common methods of providing respiratory support:~     nasal continuous airway pressure and high flow nasal cannula to see what effect it has on~     babies breathing. The investigators also will compare the effects of slightly changing the~     level of support these two different types of therapy on how easily your baby is breathing.~     Changes in the level of support and between these two respiratory support modalities are~     frequently done and are part of the routine care in the neonatal intensive care unit.~   "
116477|NCT01531452|"~     The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as~     first-line treatment of advanced gastric cancer.~   "
116478|NCT01531439|"~     There will be two groups in this study: one group will be given the standard infusion of~     naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the~     other group will receive a higher dose. The trial is designed to determine if a higher dose~     of naloxone infusion will reduce side effects from opioid therapy in patients who have~     undergone spine fusion for scoliosis.~   "
116479|NCT01531426|"~     Data indicate that neurological prognostication is difficult after cardiac arrest if mild~     therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation~     detected by near-infrared spectroscopy, could be a new, non-invasive index marker for~     outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest~     survivors with a continuously low cerebral oxygenation index have a poor prognosis.~   "
116480|NCT01531413|"~     Oxygen has inherent bactericidal properties. The investigators are testing to see if they~     can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by~     insufflating with oxygen at the end of the case.~   "
116481|NCT01531400|"~     The investigators hypothesized that self-selected music played during electrodiagnosis is~     effective in relieving the discomfort caused by the procedures.~   "
116482|NCT01531387|"~     The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy~     (hydroxyurea) to standard care (observation) in children with sickle cell anemia and~     conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative~     regimen (hydroxyurea) to be declared superior to the standard treatment regimen~     (observation), the hydroxyurea-treated group must have a three-fold reduction in the~     incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard~     treatment arm.~   "
116483|NCT01531374|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®~     System in the treatment of symptomatic severe aortic stenosis in subjects who have a~     predicted very high risk and high risk for aortic valve surgery.~   "
116484|NCT01531361|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ZelborafTM (vemurafenib) with Nexavar® (sorafenib) or Xalkori® (crizotinib)~     that can be given to patients with advanced cancer. The safety of these drugs will also be~     studied.~      Vemurafenib is designed to block a protein called BRAF V600E inside the cancer cells, which~     is involved in cancer cell growth.~      Sorafenib is designed to block the function of important proteins in and outside of cancer~     cells. These proteins are involved in cancer cells growth and new blood vessel development.~      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause~     the cancer cells to die.~   "
116485|NCT01531348|"~     The purpose of this study is to determine the feasibility and safety of adult human bone~     marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis~     pigmentosa.~   "
116486|NCT01531335|"~     The aim of this study is to compare two nutritional regimes in critically ill patients.~     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition~     (15 kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment)~     score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of~     organic failure in these patients.~   "
116487|NCT01531322|"~     This study will assess the safety and tolerability of a single dose of 13-valent~     Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in~     healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5~     years, and then infants aged approximately 2 months.~   "
116488|NCT01531309|"~     Agomelatine (AGO178) was developed for the treatment of depression. A new formulation is~     being tested in the present study: a tablet to be placed and dissolved under the tongue~     (sublingual tablet). The goal of this trial is to study the pharmacokinetics of agomelatine~     given as sublingual tablet in patients with liver impairment and to compare the results to~     those of healthy volunteers who receive the same treatment.~   "
116489|NCT01531296|"~     Determining the investigators ability to accurately assess rotational malalignment~     clinically compared to imaging.~   "
116490|NCT01531283|"~     Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology~     in healthy subjects. The proposed research is an investigator-initiated study funded by the~     National Institutes of Health designed to examine the effect of physiologic levels of UAG on~     the regulation of glucose homeostasis as well as beta cell function.~   "
116491|NCT01531257|"~     Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is~     responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy~     strongly predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians~     because current monitoring tools, namely the serum creatinine concentration, are not~     sensitive to early changes in glomerular filtration rate (GFR) or to histologic damage.~      Despite advances in prevention of acute rejection (AR), it is still a significant and~     potentially devastating complication of solid organ transplantation. One strategy to reduce~     the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection~     (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR~     can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA.~      Kidney biopsies provide better information but are limited due to safety concerns, patient~     preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow~     early intervention as well as improved graft and better patient outcomes.~      This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in~     a prospective blood, urine and kidney tissue monitoring study of kidney transplant~     recipients who will be scheduled for standard of care biopsies.~   "
116492|NCT01531244|"~     This phase I/II trial studies the safety, best dose and effectiveness of targeted gene~     therapy combined with isolated limb infusion (ILI) of melphalan and dactinomycin for~     treating patients with advanced extremity melanoma that cannot be removed by surgery. Adding~     gene therapy to a standard chemotherapy regimen in the isolated limb may enhance anti-cancer~     effects by inducing a systemic immune response against the tumor cells.~   "
116493|NCT01531231|"~     The purpose of this study is to examine the role of every day experiences as they relate to~     coronary artery disease (CAD).~   "
116494|NCT01531218|"~     A randomized, double-blind, placebo-controlled clinical trial of azithromycin in~     Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics~     of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether~     patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to~     investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced~     diarrhea can better the symptoms and shorten the duration of illness.~   "
116495|NCT01531205|"~     The aim of this study is to test whether adding chemotherapy/cabazitaxel and~     hormonal/androgen deprivation therapy before surgical removal of your prostate would improve~     the outcome of salvage surgery for locally recurrent prostate cancer after the initial~     primary radiation therapy.~   "
116496|NCT01531192|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida~     colonization. The objective of this study is to evaluate the efficacy of prophylactic~     Lactobacillus reuteri in reducing the candida colonization and infection in very low birth~     weight infants.~   "
116497|NCT01531179|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in~     newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other~     lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in~     clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing~     enterocolitis in very low birth weight infants yet. The objective of this study is to~     evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence~     and severity of necrotizing enterocolitis in very low birth weight infants.~   "
116498|NCT01531166|"~     The current proposed study aims to bring answers following issues: the antiviral efficacy~     and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected~     with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability~     or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease~     progression to liver cirrhosis and liver cancer. In addition, this study aims to collect~     more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in~     patients with CHB.~   "
116499|NCT01531153|"~     Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo~     in reducing cocaine use as measured by cocaine urine results and self-report days of use.~      Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than~     placebo in improving attention, assessed with the Rapid Visual Information Processing (RVIP)~     and the Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in~     attention during the first four weeks of treatment will mediate galantamine's efficacy in~     reducing cocaine use.~   "
116500|NCT01531140|"~     Background:~      Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing~     prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes~     lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is~     needed.~      Aim:~      The efficacy and tolerability of three different bowel cleansing protocols used in children~     for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative~     (bisacodyl) compared with sennosides.~      Methods:~      Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day~     or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days~     prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a~     blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score,~     proportions of participants with excellent/good and with poor/inadequate bowel preparation),~     and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy~     evaluated with the visual analog scale. Analysis will be done on an intention to treat~     basis.~   "
116501|NCT01531127|"~     The purpose of this study is to determine whether there is a difference in executive~     function in learning in children with ADHD receiving medical treatment alone to the~     executive function in children receiving, in addition to medical treatment in learning~     strategies.~   "
116502|NCT01531114|"~     Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial~     infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent~     implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI~     undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in~     terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg)~     in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug~     administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study~     drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing~     PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the~     drug LD administration. All patients must will be naïve for platelet P2Y12 receptor~     inhibition therapy. A subanalysis will be performed between two study groups according to~     insulin treatment.~   "
116515|NCT01530945|"~     Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis~     and comorbid conditions but also associated symptoms and acute life-threatening events that~     contribute to functional limitations and increased risk of mortality. Yet little is known~     about the trajectories of quality of life dimensions in patients with ESKD when they~     experience acute life-threatening episodes, to guide palliative care for this population. In~     this prospective, descriptive study, we will identify trajectories of symptoms, physical~     functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with~     ESKD who are at a high risk of experiencing acute life-threatening events and mortality~     within 12 months.~   "
116503|NCT01531101|"~     The First Experimental Study on Transference work - In Teenagers (FEST-IT) will be a~     randomized clinical trial, which will be designed to explore effects of transference work in~     dynamic psychotherapy in adolescents with major depressive disorder (MDD). The design of the~     study is a so-called dismantling design, in which a single component is added and/or varied~     to an existent treatment method (psychodynamic psychotherapy). Thus, the efficiency of a~     specific technique (transference interventions) can be identified.~      The primary hypothesis is that the transference group may have a more favorable course over~     time than will the comparison group.~      The second hypothesis is that patients with a history of low Quality of Object Relations~     score and/or personality disorders—might benefit more from therapy with transference work~     than from therapy without.~      The third hypothesis is that female adolescents may have better treatment effect of~     transference work than male adolescents.~   "
116504|NCT01531088|"~     Adverse drug events (ADEs) are the most clinically significant and costly medication-related~     problems in nursing homes (NH) and are associated with an estimated 93,000 deaths a year and~     as much as $4 billion of excess healthcare expenditures. Current ADE detection and~     management strategies that rely on pharmacist retrospective chart reviews (i.e., usual care)~     are inadequate. Active medication monitoring systems are recommended by many safety~     organizations as an alternative to detect and manage ADEs. These systems have been shown to~     be less expensive, faster, and identify ADEs not normally detected by clinicians in the~     hospital setting. The investigators developed and pilot-tested an active medication~     monitoring system for use in a single NH, where it was shown to detect ADEs with a high~     degree of accuracy and at a rate of nearly 2.5 times that of usual care. The long-term~     objective of our proposed research is to improve patient safety with respect to medications~     in NHs. The short-term objectives or specific aims of our proposed research are to determine~     if NH patients managed by physicians who receive active medication monitoring alerts have~     more ADEs detected, have a faster ADE management response time, and can result in more~     cost-savings from a societal perspective compared to usual care.~   "
116505|NCT01531075|"~     The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of~     IBD patients treated with immunosuppressive medications.~   "
116506|NCT01531062|"~     The purpose of this study is to determine whether Nigella sativa seed extracts are effective~     in the treatment of dyslipidemia in elderly.~   "
116507|NCT01531049|"~     The purpose of this study is to assess the efficacy and effectiveness of varenicline and~     nicotine patch combined with motivational interview technique in smoking cessation of young~     adults over 12 months follow-up.~   "
116508|NCT01531036|"~     Breast Ultrasound Elastography is a complementary technique permitting a better~     characterization of breast lesions. 3D breast ultrasound elastography is a novel technique~     permitting a volumetric calculation of lesion stiffness. This could be particularly useful~     in patients with large breast tumors under pre-operative chemotherapy~   "
116509|NCT01531023|"~     The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine~     sample cultures has been increasing over the past decades.~      The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam~     treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and~     microbiological outcome of the same group of bacteria treated with other antiinfectious~     agents.~      Samples are gathered in primary care setting.~   "
116510|NCT01531010|"~     Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for~     preterm infants in comparison to pressure-limited ventilation. This study aims to compare~     pressure-limited to VTV in preterm infants.~      Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning~     criteria compared to pressure-limited ventilation~      Primary outcome: Time taken to achieve pre-specified weaning criteria.~      Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited~     within the first 24 hours of life and randomly allocated to receive either pressure-limited~     or VTV. Adjustments to ventilator settings were made according to the trial protocol.~     Infants were deemed to have met failure criteria if they required HFOV, required peak~     pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be~     by intention-to-treat.~   "
116511|NCT01530997|"~     The purpose of this research study is to learn about the effectiveness of using~     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated~     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.~     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment~     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is~     performed afterwards. This standard regimen causes a lot of side effects and long term~     complications. This study is evaluating whether a lower dose of radiation and chemotherapy~     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in~     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy~     followed by a limited surgical evaluation.~   "
116512|NCT01530984|"~     This is an open-label randomized phase II study. Patients are randomized so as to achieve~     uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per~     treatment arm, and a total of 54 prostate cancer patients will be required to complete this~     study. The study will assess for clinical activity by Prostate Specific Antigen (PSA)~     response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in~     chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.~   "
116513|NCT01530971|"~     Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean~     section under spinal anesthesia. However, evidences supporting the practice is not clear~     nowadays, especially for healthy parturients who are monitored continuously with pulse~     oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and~     newborns.~      Changing practice is not that easy. This study has been conducted to prove that supplemental~     oxygen is not necessary for healthy parturients during cesarean section.~   "
116514|NCT01530958|"~     The purpose of this study is to evaluate the feasibility and acceptability of two different~     interventions aimed at improving health outcomes among patients with chronic kidney disease~     (CKD), who are at high risk of CKD progression. Specifically, this study will examine how~     best to implement a provider-level intervention (access to a CKD-registry) and a~     patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on~     patient health outcomes, with a 2x2 factorial design.~   "
116516|NCT01530932|"~     Sepsis remains a common entity in critical care patients with remarkable mortality.~     Pulmonary and abdominal infections (with subsequent sepsis) are the most common in the ICU.~     Despite extended research activities, no differences in patient outcome or organ dysfunction~     were revealed.~      Sepsis is a complex immune reaction phenomenon based on unbalanced activation and~     suppression. In addition to changes of cytokine levels and immune cell activity, underlying~     genetic reactions are present. For instance, expression of miRNA (as a potential important~     step of immune cell activation) is likely changed during systemic and local immune~     reactions.~      The aim of this study is to perform a detailed assay of immune cell activation, to~     investigate the levels of pro- and antiinflammatory cytokines and the various expression of~     miRNA depending on the origin of infection in the two most common sides. This means in ICU~     patients with early pulmonary or abdominal sepsis as well as in healthy controls.~     Additionally, clinical parameters of organ function, current infection markers as CRP and~     procalcitonin, cardiovascular function and heart rate variability will be assessed.~     Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma~     adenosine concentration will be measured.~   "
116517|NCT01530919|"~     The main purpose of this research study is to evaluate the effectiveness of a minimally~     invasive surgical approach to removing parathyroid gland(s). The researchers are also~     interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that~     may contribute to overactive parathyroid gland(s).~   "
116518|NCT01530906|"~     Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory~     behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious~     disease for which current treatment strategies have to be improved.~      The aim of this study is to assess whether a transcranial magnetic stimulation reduces~     bulimic symptoms in a short term.~   "
116519|NCT01530893|"~     The primary aim of this placebo-controlled study is to determine whether flavonoids~     beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated~     cardiovascular risk.~      The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and~     we will assess the effects of the food matrix, and aspects of isoflavone metabolism.~   "
116520|NCT01530880|"~     Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head~     injuries and is associated with poor recovery after injury. The current standard of care is~     to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can~     effectively reduce fever but results in a high rate of shivering. Shivering is stressful to~     the heart and can further worsen brain injury. Methods to combat shivering have been~     developed and are successful in limiting the stress in the majority of patients that use a~     body cooling device. However, the drugs used to control shivering are sedating and may also~     interfere with brain recovery.~      The purpose of this study is to assess whether ibuprofen given intravenously is more~     effective in combating fever than the current standard of care. Should results from this~     study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to~     determine whether this aggressive fever control regimen leads to improved recovery after~     brain injury.~   "
116521|NCT01530867|"~     Over half of all Americans take dietary supplements (vitamins, minerals, herbal products)~     along with their prescription medications. With the economic downturn, dietary supplement~     sales have surged, perhaps as a result of people attempting to stave off or delay medical~     care. Supplements are generally thought to be harmless, but some can potentially interact~     with prescription medications, cause liver or kidney damage, and even adversely affect~     surgical outcomes. Those substituting dietary supplements for prescription medications also~     may suffer significant adverse consequences. The United States Food and Drug Administration~     and the Institute of Medicine recommend that patients considering dietary supplement use~     consult their providers. Unfortunately, patients fail to disclose dietary supplement use in~     up to two-thirds of outpatient office visits. To improve discussions, it is important to~     understand what prompts physicians and patients to communicate about dietary supplements.~      The overall objectives of this application are to understand how, when and why physicians~     and patients communicate about dietary supplements, and to assess how patients respond to~     these discussions. An ethnically diverse group of patients and their physicians will be~     surveyed and their office visits will be audio recorded. Audio recordings of the visits will~     be used to assess the relationship of patient and physician attitudes and values, and the~     physician-patient relationship on dietary supplement discussions. A subset of these patients~     and physicians will be interviewed to explore how they made decisions to initiate or forgo~     discussions about supplements. They also will be asked questions concerning the necessity of~     and responsibility for initiating dietary supplement conversations. Patient responses and~     reactions to actual discussions also will be explored. Data from observed and reported~     interactions will be compared to provide a deeper understanding of factors related to~     disclosure. This project aims to provide a broad understanding of the content of~     physician-patient discussions about dietary supplements, and to describe how and why~     physician and patient attitudes and opinions affect these discussions. Identification of~     mutable factors can result in interventions to increase communication about dietary~     supplements, help maintain patient safety, and promote appropriate use of supplements~     concurrent with prescription medications.~   "
116522|NCT01530854|"~     Plasma free fatty acids (FFAs) are thought to play a role in the generation of organ~     dysfunction. The investigators hypothesize that plasma FFA levels are a marker of poor~     prognosis in patients with sepsis. The present study will examine the relation between~     plasma FFA levels and severity of illness in patients with sepsis presenting to the~     Emergency Department. It will also examine the relation between plasma FFA levels and the~     risk of developing late morbidity, multiple organ dysfunction syndrome (MODS) and/or~     mortality during initial hospitalization and over a 30-day follow-up period.~   "
116523|NCT01530841|"~     Myotonic dystrophy type 1 is a myopathy with complex respiratory pattern and at risk to~     develop respiratory failure. Classical mode of ventilation are sometimes not tolerated or~     ineffective in this population. New modes of nocturnal ventilation by combining both~     volumetric and barometric advantages. The aim of this study is to compare effect of AVAPS~     mode to bilevel pressure support.~   "
116524|NCT01530828|"~     This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal~     perforation in infants who are at high risk. Analysis of perforation rates of all infants in~     the three largest participating sites shows that the majority of infants with perforation~     will do so prior to day of life 21. This study will target the group of infants at highest~     risk for IP, those with birth weight less than 1000 grams, within the time frame most likely~     to capture the perforation. Hypothesis: An IRT value exists that can adequately~     differentiate premature infants with and without intestinal perforation in the first 3 weeks~     of life.~   "
116525|NCT01530815|"~     The investigators are testing to see if infusion of bupivicaine between the mesh and~     abdominal wall can reduce postoperative pain and decrease use of narcotics in the~     postoperative setting.~   "
116526|NCT01530802|"~     The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with~     vascular clips can reduce blood loss significantly.~   "
116527|NCT01530789|"~     Feasibility monocentrique opened study estimating the use of an electronic personalized~     educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6~     months having an electronic pad.~   "
116530|NCT01530750|"~     Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up~     to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks~     before the surgery. Frequency, burden, and possible risk factors will be described.~      During the operation direct contact epicardial mapping will be performed and tissue samples~     will be collected to identify an electrophysiological and a structural substrate for~     development of AF.~   "
116531|NCT01530737|"~     The primary objective of this study is:~      1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age~     undergoing cardiopulmonary bypass (CPB) for cardiac surgery~      The secondary objectives of this study are:~        1. To determine if the administration of AT concentrate prior to heparinization will~          decrease the amount of heparin required to achieve optimal anticoagulation (as defined~          by anti-Xa levels) during CPB~        2. To determine if a decrease in activation and consumption of coagulation proteins,~          platelets and subsequent fibrinolysis will result in improved haemostasis following CPB~        3. To determine if there will be a reduction in postoperative bleeding and associated~          clinical complications~   "
116532|NCT01530724|"~     The investigators hypothesize that differential dynamics in fat depots in response to two~     opposing dietary strategies mediate the beneficial metabolic effects during weight loss and~     regain phases.~   "
116533|NCT01530711|"~     Observe the effect of terlipressin on renal function in patients with SHR type I adjusting~     the dose based on hemodynamic response.~   "
116534|NCT01530698|"~     Objectives: This is an exploratory study, consisting of two parts. In part I dose escalation~     is performed and the primary objective is the safety of different doses of TLR-DC and Trimix~     DC. In part II Trimix DC vaccination will be compared with TLR-DC vaccination and the~     primary objective of this part is the immunological response, with toxicity and clinical~     efficacy being secondary objectives. These studies will provide important data on the safety~     and immunological effects of TLR-DC and Trimix DC.~      Study design: Part I of this study is an open label dose escalation study. Part II of this~     study is an open label randomized phase II study.~      Study population: Our study population consists of melanoma patients, with proven expression~     of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional~     lymph node metastasis in whom a radical lymph node dissection is performed within 2 months~     of inclusion in this study (further referred to as stage III) and melanoma patients with~     measurable distant metastases (further referred to as stage IV) will be included.~   "
116535|NCT01530685|"~     The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary~     supplement, on glycemic control of overweight prediabetic subjects.~   "
116536|NCT01530672|"~     This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio~     Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic~     platform is designed for use at point of care (POC), it is made to provide similar~     performance as reference standards. Diagnosing HIV and syphilis accurately with a single POC~     test will save time for clinic health workers and technicians, reduce loss-to follow-up~     caused by lengthy delays for lab-based tests, and save costs by eliminating the need for~     multiple tests. For this study, the sensitivity and specificity of the MBio HIV/Syphilis~     Serology System point-of-care diagnostic test will be determined using reference tests~     performed under controlled laboratory conditions. For this, clients receiving routine care~     in the ANCs at the New Nyanza Provincial General Hospital (NNPGH) and Kisumu District~     Hospital (KDH) will be consented to provide blood for the proposed study. Study volunteers~     will receive HIV and syphilis rapid tests provided as part of routine care, and will donate~     an additional blood for evaluating the MBio test against the reference tests in a laboratory~     setting. This study is an investigational prototype, not for product registration. The~     results from this study will be used to inform product development of a second iteration of~     the MBio device design. At the time that the device is ready to be registered, it will~     undergo another field evaluation at which time it will be submitted to the appropriate~     regulatory body. Because the MBIO device is an HIV test, the device would be submitted to~     National AIDS & STI Control Program (NASCOP), which is the appropriate regulatory body for~     HIV tests in Kenya.~   "
116537|NCT01530659|"~     This clinical trial is a single-site, 30 patient study for participants who have early stage~     retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and~     Foundation Fighting Blindness.~   "
116538|NCT01530646|"~     It is known that dieting (restricted energy intake) without resistance training leads to a~     reduced metabolic rate, and the loss of both fat and muscle mass. When exercise is not~     included in a period of restricted energy intake, the degree to which muscle mass is lost is~     highly dependent upon protein consumption. Whey protein is a high quality protein isolated~     from milk and is known to stimulate new protein synthesis for all proteins in your body.~     Previous research has established that the consumption of whey protein has been correlated~     with retaining muscle mass while stimulating fat loss. However, the mechanisms behind these~     findings is still unknown. The purpose of this study is to establish a mechanistic~     underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control~     (maltodextrin), in promoting fat mass loss and lean mass retention during a period of~     short-term controlled dietary energy deficit (-750 kcalories/day).~   "
116539|NCT01530620|"~     The purpose of this clinical study is to compare efficacy and safety of propiverine~     hydrochloride extended and immediate release formulations in patients suffering from~     neurogenic detrusor overactivity.~   "
116540|NCT01530607|"~     This is a phase III trial of LHRH analog administration during chemotherapy to reduce~     ovarian failure following chemotherapy in early stage, hormone-receptor negative breast~     cancer.~   "
116541|NCT01530594|"~     This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose~     dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose~     dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma~     without an intent for immediate autologous stem cell transplant.~   "
116542|NCT01530581|"~     This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF~     stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for~     Haematologic Malignancies.~   "
117181|NCT01522196|"~     The purpose of this study is to determine the effectiveness of A 001 infusion in preventing~     acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis,~     fever, and elevated serum C-reactive protein (CRP).~   "
116543|NCT01530568|"~     Aim:~      To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene~     Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically~     ventilated in ICU, using tracheal aspirates.~      Hypothesis:~      Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will~     impact on rates of treatment initiation and hospital stay.~   "
116544|NCT01530555|"~     To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG,~     Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with~     acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA)~     and who are transfusion dependent. To compare the response rate of the combination of rabbit~     ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a~     series of matched AA patients; treated after 1994 with the combination of horse ATG~     (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).~   "
116545|NCT01530542|"~     This is an open-label (both the physician and healthy volunteer know which medication will~     be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics~     (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the~     body) and the effects of food on the pharmacokinetics of oxycodone. The study will take~     place over approximately two and a half months and will consist of three phases: a screening~     visit to determine eligibility for the study, a 5-dosing period treatment phase, and an~     end-of-study visit.~   "
116546|NCT01530529|"~     The purpose of this study is to assess the bioavailability, safety, and tolerability of a~     modified-release formulation of PF-05180999 relative to an immediate-release formulation in~     healthy adult subjects. Two doses of the modified-release formulation and one dose of the~     immediate-release formulation will be evaluated under fasted conditions. One dose of the~     modified-release formulation will also be evaluated in the presence of food.~   "
116547|NCT01530516|"~     Class II malocclusion (mismatch between the upper and lower jaw in which the lower jaw~     appears to be smaller from a profile point of view) are common in the general population.~     Around 1/3 of the population have some degree of this skeletal/dental problem and it is one~     frequent reason why patients decide to undergo orthodontic treatment. Treatment alternatives~     will basically depend on the facial skeletal development of the patient and also on the~     magnitude of the skeletal/dental discrepancy.~      For patients that are not yet fully skeletal mature, the treatment of mild to moderate Class~     II malocclusion involves a combination of a small skeletal growth modification effect and~     more significant dental movements. For skeletal mature individuals with a severe mismatch,~     the treatment usually involves jaw surgery to fully correct the malocclusion. For less~     severe cases orthodontic camouflage exclusively done by orthodontic movements is an option.~      If the case is not severe enough to warrant a surgical approach there are several treatment~     alternatives. One of the most commonly used options is the use of orthodontic loaded springs~     that apply forces through brackets and arch wires bonded into the teeth so that the teeth~     will interrelate better.~      A different alternative was proposed some years ago. The Xbow (spelled Crossbow) appliance~     differs from the above-proposed option in that no brackets are bonded or arch wires used.~     The orthodontic springs are applied to a metal framework cemented on some upper and lower~     teeth. Once the skeletal/dental problem is believed to have been significantly improved,~     fine tuning of the remaining dental problems is managed with brackets and arch wires. The~     theoretical advantage of such a design is that adverse effects, such as root resorption and~     decalcification from the long-term use of brackets and arch wires, are theoretically~     minimized as the brackets and arch wires have to be used for a shorter period of time.~      Although there are some retrospective reports about the skeletal and dental effects of the~     Xbow appliance and only one prospective trial comparing the skeletal and dental changes to a~     non-treated growing sample; no randomized clinical trial has yet evaluated the changes~     compared to a current standard of care alternative which is the simultaneous use of loaded~     springs concurrent with brackets and arch wires.~   "
116548|NCT01530503|"~     The purpose of this study is to assess the therapeutic activity of capecitabine alone or in~     combination with mitomycin C as second-line therapy in patients with advanced/metastatic~     biliary adenocarcinoma in progression after gemcitabine and platinum compounds~   "
116549|NCT01530490|"~     The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF)~     cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of~     cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.~   "
116550|NCT01530477|"~     This study is being conducted to examine the performance of three common DXA machines (1)~     Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body~     fat.~   "
116551|NCT01530464|"~     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with~     the primary objective of testing the safety and tolerability of combined oral doses of~     aminophylline and ambrisentan in healthy human subjects. The secondary objective is to~     assess the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when~     administered alone or in combination. It is hypothesized that the combination of these drugs~     is generally safe, and that no drug interaction can be observed.~   "
116552|NCT01530451|"~     The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia~     in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the~     quality of life will be measured.~   "
116553|NCT01530438|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only~     motor structures, as was previously thought, but also brain areas dealing with cognition as~     well as parts of the limbic system. Clinical, imaging and pathological evidence suggests~     that ALS and fronto-temporal dementia (FTD) have several features in common, and that these~     two diseases could be the two ends of a pathological continuum.~   "
116554|NCT01530425|"~     Two wheelchair types available for children in Kenya are compared for energy costs, utility,~     and complications. This study will arrive at a protocol for comparing wheelchairs in~     low-income settings, and in the process, provide wheelchair makers and providers with~     specific feedback. It also serves as a means to increase the skills of local health~     professionals working with the children in this study, while providing them with appropriate~     wheelchairs to use.~   "
116555|NCT01530412|"~     Sustained improvement after pulmonary rehabilitation in activity levels as measured by an~     activity armband.~      Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and~     prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also~     strong evidence that supports the use of pulmonary rehabilitation to decrease hospital~     admissions thereby reducing cost of care. Recent studies suggest that the significant~     benefits achieved through rehabilitation fade with time and that in order to improve~     activities of daily living; for example, average daily number of steps, programmes of longer~     duration are required.~      The primary aim of this study is to identify objective sustained improved in activity levels~     using the SenseWear activity armband after a short-term pulmonary rehabilitation programme.~     Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.~   "
117182|NCT01522183|"~     Post-marketing safety data on patients treated and untreated with eculizumab.~   "
116556|NCT01530399|"~     The objective of this study is to determine the dose response relationship regarding blood~     loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid~     in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the~     study is to define minimally effective dose of MDCO-2010.~   "
116557|NCT01530386|"~     The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated.~     The present study is being conducted to assess the effects of Lacosamide on sleep quality in~     healthy subjects.~   "
116558|NCT01530373|"~     Hot flashes present a considerable problem for many breast cancer patients; these symptoms~     may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This~     study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in~     reducing hot flashes, compared with clonidine (a medication often used for treating hot~     flashes).~   "
116559|NCT01530360|"~     Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The~     investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of~     hyper- and hypoxia can be accomplished during the first three days of life in infants born~     before 28 completed weeks of gestation. The investigators developed a treatment guideline~     and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can~     be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in~     10 infants.~   "
116560|NCT01530347|"~     Segment 1- this segment will include two main steps:~      Step 1-Calibration: During this step we plan to collect paired measurements of capillary~     blood glucose using reference method and data generated by the non invasive study device.~     Samples will be obtained at specific time points during 4 hours: at fasting, and after~     consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary~     blood glucose will be measured using the invasive reference method. The paired reference and~     study device data will be analyzed using multivariate regression model to formulate a~     calibration algorithm model. This model will convert the acetone values measured by study~     device to blood glucose values.~      step 2-Validation: During this segment the second step of this segment we plan to evaluate~     the validity and reliability of the non-invasive breath-based glucometer compared to~     standard invasive reference glucometer. Results will be compared using a Clark error grid.~      Segment 2- During this segment we plan to collect paired measurements of capillary blood~     glucose beta Hydroxybutyrate using reference method and acetone values generated by the non~     invasive breath based study device. Samples will be obtained at specific time points during~     4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to~     produce ketosis.~   "
116561|NCT01530334|"~     the primary objective is to characterise the impact of gefitinib on the Response Evaluation~     Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ;~     confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR;~     confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients~     with EGFR M+ NSCLC~   "
116562|NCT01530321|"~     This study will determine the number of visits to a chiropractor for spinal manipulation and~     light massage necessary for the optimal relief of cervicogenic headache (headache with~     associated neck pain). Effectiveness of care will also be determined.~   "
116563|NCT01530308|"~     The investigators propose a multicenter, randomized, double-blinded, placebo-controlled~     trial to study the effect of additive low-dose haloperidol prophylaxis on top of exciting~     care in a general population of older patients (age 70 years and over) acutely admitted to~     the hospital through the emergency department (ED) for general medicine and surgical~     specialties, and who are at-risk for developing in-hospital delirium on admission according~     to the VMS delirium risk questions (one or more positive answers out of three questions).~      The investigators hypothesize that this intervention will reduce the incidence of~     in-hospital delirium as well as duration and severity of delirium.~   "
116564|NCT01530295|"~     Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in~     Patients with High Risk Prostate Cancer.~      The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and~     prednisone are effective in the treatment of high risk localized prostate cancer.~   "
116565|NCT01530282|"~     The study aims to assess the agreement between respiratory mechanics parameters measured~     noninvasively by means of brief airways occlusions at the beginning of inspiration and the~     reference parameters obtained with standard techniques of esophageal and gastric pressure~     under static and dynamic conditions in a mixed population of ICU patients mechanically~     ventilated in pressure support ventilation mode.~   "
116566|NCT01530269|"~     Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant~     metastases from prostate cancer. This clinical trial is studying how this imaging test may~     help influence the choice and extent of initial treatments, and subsequent treatments.~   "
116567|NCT01530256|"~     The purpose of this study is to determine the safe and tolerable, biologically active, and~     potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to~     respond to glucocorticosteroids, for further investigation in Part B.~   "
116568|NCT01530243|"~     The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin~     and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.~   "
116569|NCT01530230|"~     The investigators examined whether there was a difference in the occurrence of ST~     depressions after injection of five or ten units of oxytocin, in preeclamptic patients~     delivered by caesarean section (CS) under regional anesthesia.~   "
116570|NCT01530217|"~     Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study~     is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office~     bleaching.~      Methods: 30 health adults who received either placebo or ibuprofen. The drugs were~     administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours~     during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity~     will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4.~     The shade evaluation will be performed before and 30 days after bleaching with visual shade~     guide and spectrophotometer.~   "
116571|NCT01530204|"~     The primary question addressed by this prevention study is to explore if improving pain and~     disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA)~     and mild depressive symptoms.~   "
116572|NCT01530191|"~     The specific aim of this study is to determine if pre-existing depression and anxiety affect~     perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.~        -  Hypothesis 1: Patients with depression will have increased analgesic use and longer~          hospital stays postoperatively~        -  Hypothesis 2: Patients with anxiety will have increased analgesic use and longer~          hospital stays postoperatively.~      A secondary aim is to characterize the incidence and severity of depression and anxiety in~     patients scheduled to undergo surgery for pelvic organ prolapse.~   "
116573|NCT01530178|"~     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal~     sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to~     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.~     This study is going to test whether this drug can improve the after meal sugars in people~     with type 1 diabetes. To test this you will be given a test mixed meal and its effects on~     insulin, other hormones that affect blood glucose as well as your sugar will be measured by~     a series of blood tests. Insulin dose will be reduced by 20-50% to prevent low blood sugars~     which might occur because of food staying longer in the stomach than usual or due to the~     suppression of a hormone called glucagon which increases blood sugar. If you qualify you~     will be given sitagliptin (Januvia) 3 different times in 25 mg, 50 mg and 100mg dosages. You~     and the researchers will not know which dose you are taking at any single visit. A total of~     30 people in which some will be children aged 13- 17 and others will be adults aged 18-30~     will participate. Some will have had diabetes for over a year, others will be within 3~     months of having been found to have type 1 diabetes. Furthermore, only 18-30 year people who~     are diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects)~     to establish safety data before younger subjects are enrolled into the study.~   "
116574|NCT01530165|"~     The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the~     prevention of type 2 diabetes. Approximately 20,000 people From four communities will be~     screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those~     found to be at increased risk will be given an oral glucose tolerance test. People who,~     after the oral glucose tolerance test, are identified as having prediabetes will have the~     opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention.~     This consists of culturally adjusted preventive strategies focusing on diet and physical~     activity in real-life settings. Another important aspect of this trial will be to assess the~     impact of urban planning on the prevalence of obesity and diabetes.~   "
116575|NCT01530152|"~     Aim:~      The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture~     Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis~     for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.~      The laryngoscopes are compared according to their ability to visualize the glottis area~     measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.~      A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible~     decrease of the saturation will also be made.~      Hypothesis:~      The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes~     the intubation les difficult.~      CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the~     hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview~     PCD™ laryngoscope.~   "
116576|NCT01530139|"~     The concept of personalised nutrition emerged following the sequencing of the human genome~     in 2000. It was hoped that with the identification of gene nutrient interactions, an~     individual's response and susceptibility to particular diets would be better understood and~     therefore appropriate dietary modifications could be made to optimise health and lower~     disease risk. Then Food4Me aims to study the development of personalized nutrition at three~     levels and determine whether providing more personalised dietary advice leads to better~     compliance and health outcomes compared to standard population advice.~      The hypotheses to be tested in the Food4Me study are as follows:~        -  Personalisation of dietary advice assists and/or motivates consumers to eat a healthier~          diet and follow a healthier lifestyle (in comparison with impersonal [conventional]~          dietary advice).~        -  Personalisation based on individualised biochemical (phenotypic) and/or genetic~          information is more effective in assisting and/or motivating study participants to~          make, and to sustain, appropriate healthy changes to their usual (habitual) diet and~          lifestyle.~   "
116577|NCT01530126|"~     The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth~     Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced~     periodontal osseous defects at 6 months of healing.~   "
116578|NCT01530113|"~     The study aims to develop a theoretical model explicating the inter-relationships between~     Childhood Sexual Abuse (CSA), Partial Vaginismus (PV) and Labor Dystocia (LD), including~     their associations with Depression (D) as a mediating variable.~      The following research hypotheses will be tested:~        1. CSA will serve as a risk factor for D, PV and LD.~             -  pregnant women with a history of CSA will have higher levels of D compared to~               pregnant women without a history of CSA.~             -  pregnant women with a history of CSA will have more PV compared to pregnant women~               without a history of CSA.~             -  pregnant women with a history of CSA will have higher levels of LD compared to~               pregnant women without a history of CSA.~        2. D will serve as a mediator between prenatal PV and LD.~        3. PV will serve as a risk factor for LD.~        4. postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of~          D.~   "
116579|NCT01530100|"~     This study will examine the use of lower laser therapy to reduce edema and pain in~     orthognathics surgery.~   "
116580|NCT01530087|"~     The purpose of this study is to provide preliminary assessment of the safety and performance~     of a novel barrier formulation (CASTLE) in a small population of subjects with irritated~     peristomal skin.~   "
116581|NCT01530074|"~     The purpose of this study is to determine the contribution of the innervation of the~     contra-lateral mandibular nerve for the innervation of the lower lip area.~      The investigators hypothesis is that the sensation of the lower lip is contributed by both~     mandibular nerves (from both sides of the jaw).~   "
116582|NCT01530061|"~     This study will determine which breakfast (egg breakfast or bagel breakfast) has the most~     beneficial effect on appetite.~   "
116584|NCT01530035|"~     A one-year intervention study of 41 healthy elderly men aged 65-75-years.Of these, 24~     subjects are untrained men with no regular training activity for the last 5 years. After~     medical screening and pre-testing, they will be randomized into a football group (n=9), a~     strength-training group (n=9) or a sedentary control group (n=6). Additional 17 subjects are~     recruited from local football clubs and have been active football players for the last 40~     years. Training will be performed 3x1 hour per week and evaluation will take place after 0,~     3 and 12 months. Primary endpoints will be changes in cardiac and vascular structure and~     function measured by advanced echocardiography (tissue Doppler and speckle tracking~     imaging), and peripheral arterial tonometry (Endo--‐PAT device). Secondary endpoints will be~     evaluation of potential changes in VO2 max, blood pressure, muscle capillaries, lipid~     profile, circulating catecholamines, body composition, and insulin resistance.~   "
116585|NCT01530022|"~     The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological~     effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after~     administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also~     be collected.~   "
116586|NCT01530009|"~     The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable~     effect on upper gastrointestinal motility compared to placebo. In particular, induction of~     phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary~     outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular~     contractions that pass through the walls of the stomach and intestinal tract during the~     fasting state. It is characterized by an initial period where there is a minimal electrical~     activity and muscular contraction (phase I), followed by a gradual increase in the frequency~     of contractions (phase III) that often leads to a characteristic cluster of contractions~     (phase III). This cycle occurs only in the fasting state in normal individuals and the~     frequency of phase III is quite varied, dependent on age and the presence of any underlying~     abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics~     of the MMC, patient demographics in responders and non-responders, and the safety profile of~     AMX at the intervention dose.~   "
116587|NCT01529996|"~     The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG~     laser in the treatment of facial redness.~   "
116588|NCT01529983|"~     The primary objective of this study is to compare the efficacy of intense focused ultrasound~     and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.~   "
116589|NCT01529970|"~     Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after~     Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor,~     rigidity and postural instability. Although PD appears to be sporadic in most cases, several~     causative genes and susceptibility factors have been identified that cause familial forms of~     the disease with Mendelian inheritance with autosomal dominant or autosomal recessive~     inheritance.~      Approximately 5~10% of patients with the clinical picture of PD carry a mutation in one of~     the known genes that cause monogenic forms of the disorder. The average age at onset is~     between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary~     parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and~     50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile~     parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is~     aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA~     sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and~     ATP13A2 (pattern: PARK9).~   "
116590|NCT01529957|"~     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in~     healthy Chinese volunteers.~   "
116591|NCT01529944|"~     This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation~     status and investigate the impact of the PTPN11 mutation status on the effect of somatropin~     (Norditropin®) by use of data obtained in the GHNOO-1658 trial.~   "
116592|NCT01529931|"~     The current study is a follow up study designed to gather information about the effect of~     the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic~     Hair2Go treatment. This study includes taking photos and documenting endpoints but does not~     include treatments.~   "
116593|NCT01529918|"~     This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential~     value of a strategy for web-diabetes risk assessment versus paper-based methods in an~     undiagnosed diabetes population over 40 years of age from all listed FHT provided through an~     electronic medical record database. Following randomization, intervention participants will~     have the option to decide to use web-based self-screening and the control group will receive~     only a paper-based method. There will be two options for web-based screening; one involves~     completion of the CAN-RISK screening tool as part of a personal health record~     self-management program (MyOscar) versus a one off online risk-assessment. The intervention~     and control group will be compared with respect to risk-assessment uptake. Educational~     sessions and further assessment of diabetes conducted by the clinical health care team will~     be offered to all participants who scored a high risk of diabetes in accordance with the~     CAN-RISK results. Actual numbers of diabetes cases in those with a high risk score will be~     compared between the intervention and control groups as well as compared to the usual method~     of diabetes screening in a randomly chosen non-identifiable sample from the same clinical~     setting in the same one year period. The assessment of patient acceptability in feasibility~     of the implementation of the self-screening tool will be accomplished through surveys~     designed to be completed by patients and staff.~   "
116594|NCT01529905|"~     The goal of this project is to study the course and outcome of illness in individuals who~     present with a first episode of depression or mania, or who have a recurrent disorder but~     have never received treatment. We plan to examine psychological, physical, social and~     environmental factors that may affect long-term outcome in these disorders~   "
116633|NCT01529398|"~     People with knee osteoarthritis (OA) have functional instability and defective neuromuscular~     function, it was recently suggested that sensorimotor exercises may be important and needed~     to improve the effectiveness of training programs for these patients. This study objective~     was to compare the effectiveness of a supervised resistance muscular training (RT) versus~     sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional~     improvement.~   "
116595|NCT01529892|"~     Methamphetamine abuse and addiction are widespread and is causing increasing pressures on~     social, public health and criminal justice systems worldwide. Some of the risk for~     developing addiction may be genetic. Identifying specific genotypes and understanding their~     interactions with the environment may help predict who is at risk for developing a disease.~     In this study the investigators are evaluating the contribution of differences in one~     genotype - called CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is~     removed from the body by special enzymes in the liver. One of these enzymes is called~     Cytochrome P450 2D6. The activity of 2D6 is genetically determined. Some people have no~     active 2D6 whereas in others 2D6 is very active. One group of scientists found that people~     with low 2D6 activity were less likely to become methamphetamine addicts. In this study the~     investigators will determine the activity of your 2D6 by looking at the CYP2D6 genotype. If~     low levels of 2D6 decrease the risk of methamphetamine addiction it may be because there is~     less of the chemicals (called metabolites) made by 2D6. The first step in the metabolism~     (the process of removal of drugs from the body) of methamphetamine by 2D6 is conversion of~     methamphetamine to amphetamine and para-hydroxymethamphetamine. 2D6 then converts these to~     inactive chemicals. In addition to determining your genotype, the investigators are~     interested in the relationship of genotype with the methamphetamine metabolism. Thus, as~     part of this study, you will be given a modest oral dose of 5 milligrams of methamphetamine.~     After receiving the methamphetamine you will need to collect your urine for 24 hours.~      The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the~     disposition of methamphetamine in the human body as well as its pharmacologic effects to~     humans.~   "
116596|NCT01529879|"~     Integration success rates and the preservation of crestal bone will be higher for the~     experimental device than for the control implants.~   "
116597|NCT01529866|"~     Integration success rates measured by lack of implant mobility and crestal bone regression~     measurement will be higher for the experimental implant design than for the control~     implants.~   "
116598|NCT01529853|"~     Primary Objective:~      To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and~     tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly~     over a 6-week period.~      Secondary Objectives:~      To assess in adult patients with IPF:~        -  The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests~          (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.~        -  The trough plasma concentrations of SAR156597~        -  The potential immunogenicity of SAR156597.~   "
116599|NCT01529840|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of~     somatropin (Norditropin®) on final height in children with Noonan syndrome having being~     treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal~     final height in the original trial S/GHD/004/NOO.~   "
116600|NCT01529827|"~     This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose~     total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT)~     works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as~     fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the~     growth of cancer and abnormal cells and helps stop the patient's immune system from~     rejecting the donor's stem cells. When the healthy stem cells from the donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an~     immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil~     (MMF), and methotrexate after transplant may stop this from happening~   "
116601|NCT01529814|"~     Integration success rates measured by resistance to countertorque testing will be higher for~     the experimental implant design than for the control implants.~   "
116602|NCT01529801|"~     A study where dental implants with different roughened surfaces will be evaluated for the~     ability to resist countertorque forces.~   "
116603|NCT01529788|"~     The objective of the study is to compare the time to onset of Dysport® versus Botox® in the~     treatment of lateral orbital rhytids (crow's feet). Thirty subjects were enrolled in the~     study; specifically 30 male or female patients 18 years or older with moderate to severe~     lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated~     with Dysport® on one side and Botox® on the other side. Both the injector and patient were~     blinded to the injected toxin.~      The efficacy endpoints were determined by investigator and subject live assessment of~     crow's feet at rest and maximum contraction at each visit (every other day for 6 days~     post-injection, every month for 9 months following) using a validated 5 point photographic~     scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or~     severe wrinkles [4]) used in previous studies. A written description of each photograph was~     included to help standardize the application of the Photographic Scale.~   "
116604|NCT01529775|"~     This study will demonstrate the benefits of platform switching design of the Osseotite~     dental implant.~   "
116605|NCT01529762|"~     Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.~   "
116606|NCT01529749|"~     This is a open controlled trial in which 48 HIV-1 patients successfully treated with~     EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1).~     The four arms are as follows:~      Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF +~     MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)~      The allocation will take place in two phases:~      Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan~      If losartan arm shows benefits we will proceed to the second phase:~      Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.~      Patients will be followed up during 12 months to determinate the proportion of patients with~     decreased collagen deposition in TL equal to or greater than 50%.~   "
116607|NCT01529736|"~     Osseotite implants placed with higher insertion torque (TEST procedure) will have higher~     initial stability and integration success than those placed with lower insertion torque~     forces.~   "
116608|NCT01529723|"~     Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke~     survivors depending on the anatomic location of the stroke and the diagnostic test used.~     There are no universally accepted methods for doing a screen test at the bedside in the~     immediate setting after stroke. This study will assess the reliability of a bedside screen~     in terms of reproducibility of results between 2 independent screeners and in comparison to~     a fiberoptic study done by a speech language pathologist.~   "
116634|NCT01529385|"~     The purpose of this study is to determine whether a specially designed sock for people with~     diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs,~     and improve physical activity patterns of those individuals by providing mild compression to~     their legs.~   "
116635|NCT01529372|"~     The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be~     conducted on twenty (20) eligible patients with a twelve month follow-up period.~   "
116609|NCT01529710|"~     Clinical Trial Phase:Phase III~      Primary Objectives:~        -  Compare Mirazid and Praziquantel cure rates for both Schistosoma species.~        -  Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both~          Schistosoma species.~      Secondary Objective:Identify and compare the types and severity of side and adverse effects~     between the Mirazid and Praziquantel.~      Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged~     from 15-35 years. Those subjects will be selected from among those screened.Subjects will~     include both genders excluding chronically ill such as chronic liver disease patients and~     those with both types of Schistosomiasis.~      Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months~     for statistical analysis and report writing Study Duration: Total study duration is expected~     to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data~     management and report writing.~      Endpoints: Will be measured at 3 months of successful administration of treatment either~     Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the~     response to treatment will be done by examining urine or stool of the subject for presence~     of Schistosoma eggs and its density if found.~      Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will~     indicate treatment success. One positive sample collected at week 12 will indicate infection~     with Schistosomiasis.~   "
116610|NCT01529697|"~     Inhaled medications are the mainstay of the therapeutic management of respiratory disorders.~     Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are~     often improperly used. However, there is no tool that can detect and record errors in either~     the timing or the method dose administration~      The investigators designed a device that makes an acoustic record each time an inhaler is~     used. Opening the device makes an acoustic file which is recorded, this file is~     time-stamped which means that the timing of drug administration is recorded. When the~     device is retrieved and acoustic analysis performed, the steps involved in using the inhaler~     can be determined. Hence, the subjects inhaler technique is assessed and errors in the~     inhaler use identified. Together this means that errors in inhaler technique and timing of~     use can be quantified.~      In this study the investigators attached the device to a discus dry powder inhaler. In order~     to eliminate the behavioral component of adherence and identify the mechanical issues~     associated with effective inhaler use the investigators studied subjects who were already in~     Hospital and already prescribed a discus inhaler. The investigators hypothesized that the~     device would identify which errors in technique were the most common and that this would~     provide insight into how these errors might be eliminated.~   "
116611|NCT01529684|"~     The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of~     excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled~     OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the~     Optional Treatment Phase.~   "
116612|NCT01529671|"~     The purpose of the study is primarily to determine the safety and toleration and~     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.~   "
116613|NCT01529658|"~     The Objective is to determine if renal hypothermia during open partial nephrectomy results~     in improved post-operative renal function compared to warm ischemia.~      Primary Aim is to determine the effect of hypothermia on preservation of overall renal~     function compared to no hypothermia in patients who require hilar vessel clamping during~     open partial nephrectomy for a renal tumor.~      Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal~     function.~      Secondary Aim is to determine the effect of hypothermia on preservation of affected renal~     function (kidney with the tumor) compared to no hypothermia in patients who require hilar~     vessel clamping during open partial nephrectomy for a renal tumor.~      Hypothesis: Hypothermia will result in improved post-operative preservation of affected~     renal function.~   "
116614|NCT01529645|"~     This study will evaluate the safety and efficacy of 9 different vaccines containing aP~     (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy~     subjects 18 to 40 years of age.~   "
116615|NCT01529632|"~     The study assessed the safety and efficacy of the fixed combination product QVA149 versus~     the component products QAB149 and NVA237, administered concurrently, in patients that have~     moderate to severe chronic obstructive pulmonary disease (COPD).~   "
116616|NCT01529619|"~     This is a multicenter study to evaluate the efficacy, safety and tolerability of~     Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from~     Cholinesterase Inhibitors.~   "
116617|NCT01529606|"~     The main objective of this entire research project is to develop a miniature atmospheric~     cold plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical~     trial portion of the study is to compare the longevity and durability of dental composite~     restorations created using the plasma brush, to that of the standard care in dentistry for~     treating dental cavities, and effects on caries prevention.~   "
116618|NCT01529593|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of temsirolimus and metformin that can be given to patients with advanced~     cancer. The safety of the drug combination will also be studied.~      Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause~     cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread~     of cancer cells or possibly kill them.~      Metformin was designed to treat patients with diabetes. It may be able to block the protein~     mTOR and slow the growth of tumors.~   "
116629|NCT01529450|"~     This is a prospective single-center, open label, pilot study to investigate the safety and~     efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.~      Primary Objectives:~      • To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of~     individuals with locally advanced or metastatic BCC who have been previously treated with a~     non-LDE225 Smo inhibitor.~      Secondary Objectives:~        -  To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii~          1, 2, Patched 1,2 and Ki67) in individuals which are non-naive to Smo inhibitors other~          than LDE225, at baseline and at end-of-treatment~        -  To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225~          Smo inhibitor usage~        -  To assess the overall survival rates of individuals with locally advanced BCC or~          metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment~          with LDE225~   "
116619|NCT01529580|"~     This project will address a major challenge to the field of autism research: improving~     expressive communication in children with autism who have reached school age but have not~     acquired functional spoken language (non-verbal school aged children with autism; NVSACA).~      Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy~     Krieger site and follow-up testing but continue to have minimal functional spoken language~     will be participants in this study. After eligibility is established, participants will be~     randomly assigned to a baseline duration of one week, two weeks or three weeks before the~     start of active treatment. Once the baseline duration is completed, participants begin~     active treatment one hour of intervention three days per week in the participants' school~     setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings~     begin to improve the child's generalization of skills and teach parents the strategies~     implemented in their child's treatment. Post-baseline and post-treatment assessments will be~     completed in the lab at a time that is convenient for the participants' families.~   "
116620|NCT01529567|"~     Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral.~     They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs.~     Both programs include mindfulness training, education about how excessive avoidant and~     control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer~     life. One of the programs also includes instructions on how to perform systematic exposure.~     The hypothesis of the study is while both groups will show improvement in terms of IBS~     symptom severity and quality of life, the addition of systematic exposure will lead to more~     improvement in symptoms.~   "
116621|NCT01529554|"~     Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and~     death rates and morbidity remain substantial in the years thereafter. Inflammation is a~     hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as~     well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing~     its harmful consequences constitutes an attractive therapeutic approach to address this~     unmet medical need.~      The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on~     infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial~     Infarction.~      The efficacy objectives are:~        1. (1° endpoint):~           To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as~          change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days~          follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality).~        2. (2° endpoint):~           To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after~          percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.~        3. (3° endpoints):~             1. Change of left ventricular volume from baseline (12-72 hours after percutaneous~               coronary intervention) to 30 days follow-up measured by MRI.~             2. Change of biomarkers from time of coronary angiography to 30 days follow-up~               including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6~               and inflammatory biomarkers OPG, sRANKL, OPN and CCN1.~      The safety objectives are:~      To explore the effect of mTOR inhibition (everolimus) on several clinical and safety~     laboratory parameters including plasma lipid levels and blood count. This will be~     complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral~     blood (CD4+ T helper lymphocyte subsets, monocyte subsets).~   "
116622|NCT01529541|"~     This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by~     proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled~     with metformin alone.~   "
116623|NCT01529528|"~     This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice~     daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by~     diet therapy or combination of diet and exercise therapy.~   "
116624|NCT01529515|"~     The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month~     formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse~     of the symptoms of schizophrenia.~   "
116625|NCT01529502|"~     The purpose of this study is to determine whether storage time affects how human body~     responds to autologous blood transfusion. An autologous blood transfusion is when a person~     donates blood and then receives that same blood back in the transfusion. We also want to~     find out if in this situation inhaled nitric oxide can help to prevent the potential~     reduction of vasodilation capacity. Vasodilation capacity is the ability of the blood vessel~     to widen when needed.~   "
116626|NCT01529489|"~     Patients with chronic obstructive pulmonary disease (COPD) present slowed pulmonary oxygen~     uptake (VO2) and heart rate (HR) kinetics compared with age-matched controls. Patients with~     COPD present significant loss of body mass, decreased strength and endurance of respiratory~     muscles and lower limbs, leading reduced exercise capacity. This reduced exercise capacity~     can be marked by slowed kinetics of VO2 and HR at the onset of heavy-intensity exercise.~     Additionally, derangements in the diffusive and convective transport of oxygen to skeletal~     muscle mitocondria, and intramyocyte metabolic machinery, higher ventilation and~     disturbances in mechanics of breathing, hypoxemia, pulmonary hemodynamics, autonomic~     balance, and peripheral vasodilation, and accumulation of by-products that might be related~     to increased muscle fatigability could slow the response of systemic (central) and~     peripheral (microvascular) oxygen delivery to a point where the kinetics of VO2 might become~     limited by O2 availability and HR. Thus, the physical training programs of the lower limbs,~     in addition to presenting scientific evidence A, are important components, resulting in~     the reversal of the manifestations of COPD, resulting in improvement in exercise capacity,~     well significantly speeded VO2 and HR kinetics in patients with COPD. However, it should be~     taken into account the choice of an appropriate program limitations and severity of disease.~     Assuming that COPD patients present slower VO2 and HR kinetics, the investigators~     hypothesized that the heavy-intense interval physical training in equipament elliptical~     would promote a greater increase in the functionality (functional performance) and speeded~     kinetics in the cycle ergometer and elliptical equipment constant-load intense exercises~     tests of COPD patients. In this context, the present study intends to evaluate and compare~     the effects of resistive plus aerobic physical training and interval physical training on~     oxygen consumption (VO2) and heart rate (HR) kinetics responses at the onset in cycle~     ergometer and elliptical equipment constant-load intense exercises tests in patients with~     COPD.~   "
116627|NCT01529476|"~     1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with~          Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)~        2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients~          with CAP after continuous oral administration and determine the pharmacokinetic~          (PK)/pharmacodynamic (PD).~   "
116628|NCT01529463|"~     The purpose of this study is to test the hypothesis that a comprehensive post-discharge~     disease management system is more effective in reducing the readmission rate for heart~     failure patients compared to standard care.~   "
116630|NCT01529437|"~     This is a study for children and adults who are interested in a new therapy for their~     allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy~     and the investigators are testing if it is safe and well tolerated.~   "
116631|NCT01529424|"~     The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS~     ApoC-III Rx vs. Placebo on fasting total apoC-III levels.~   "
116632|NCT01529411|"~     This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine~     administered after the standard treatment of the combination gemcitabine+cisplatin, when it~     has reached stabilization or response of the disease, as the first treatment inmeditely~     after the diagnosis of advanced or metastatic urothelial cancer.~   "
116642|NCT01529281|"~     It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function~     and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation~     has been shown to increase protein synthesis and decrease muscle protein breakdown, however,~     the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to~     examine the effects of a BCAA supplement on markers of muscle damage.~   "
116643|NCT01529268|"~     CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years~     with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD). The~     primary objective is to evaluate whether 52 weeks of treatment with cysteamine bitartrate~     delayed-release capsules will result in improvement in liver disease severity.~   "
116644|NCT01529255|"~     -  The purpose of this study is to to prove that the long-term efficacy of strategy of~          treatment adjustment at W24 according to virological response based on ROADMAP concept~          is better than standard of care strategy.~        -  To evaluate the off-treatment durability of HBeAg seroconversion in patients who~          discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml~          with over 12 months consolidation treatment~   "
116645|NCT01529242|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of acute cutaneous rash in children between 2~     and 12 years old.~   "
116646|NCT01529229|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of Moderate - Severe Persistent Allergic~     Rhinitis.~   "
116647|NCT01529216|"~     The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND~     System (A third Generation) in comparison to a sham treatment in terms of Glycemic control,~     measured as A1c, FBG and Post-Prandial Glucose levels.~      The study hypothesis is that HbA1c will show greater improvement in patients receiving 12~     months of therapy by the DIAMOMD System than in patients not receiving this therapy.~   "
116648|NCT01529203|"~     The aim of this study is to assess subjects' satisfaction linked to the pan facial~     management of rejuvenation with injections of Azzalure® and Restylane® fillers.~      This will be an open, multi-centre study.~   "
116649|NCT01529190|"~     Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been~     shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting~     central sensitization. The IL-6, is detectable 60 minutes after surgical incision,~     persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective~     of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum~     levels of IL6.~   "
116650|NCT01529177|"~     Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic~     abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian~     disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment~     with metformin.~   "
116651|NCT01529164|"~     Studies suggest that the addition of antiangiogenic agents to conventional therapeutic~     strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase~     clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has~     become an important treatment option and its combination with chemotherapy is now being one~     of the standard first line therapy. This phase II study was conducted to determine the~     efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in~     advanced colorectal cancer.~   "
116652|NCT01529151|"~     Western University of Health Sciences is seeking men and women to participate in a study on~     the effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation~     Therapy (VRT) in patients with vertigo. The purpose of this study is to examine the efficacy~     of OMT in the treatment of individuals with vertigo, alone and in combination with~     Vestibular Rehabilitation Therapy (VRT). Because of the health care costs associated with~     vertigo, the cost effectiveness of OMT and VRT will also be examined.~   "
116653|NCT01529138|"~     This study is being done to determine the highest safe dose of the combination of~     temsirolimus and axitinib; to learn the side effects when these drugs are given together;~     and to determine how the patient's disease responds to treatment.~      The combination of the drugs temsirolimus and axitinib has not been studied before so it is~     unknown whether this treatment will have any benefit in the patient's cancer.~      Temsirolimus is commercially available and approved for treatment of some types of kidney~     cancer.~      Axitinib has been tested in several diseases but it is not yet commercially available for~     the treatment of any cancer in the United States.~      The combination of temsirolimus and axitinib is not approved for treatment of any cancer~     outside of a clinical trial.~   "
116654|NCT01529125|"~     It is unclear whether children with HIV and severe acute malnutrition can be started on~     highly active antiretroviral therapy (HAART) safely while they are still malnourished and~     the manner in which this therapy should start. This study will examine the safety, efficacy,~     and metabolism of children started on HAART while still severely malnourished.~   "
116655|NCT01529112|"~     The purpose of this study is to compare the overall survival of patients receiving E7080 +~     Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.~   "
116656|NCT01529099|"~     This is a postmarketing study to assess the overall performance and survivorship of the~     SIGMA HP® PARTIAL KNEE SYSTEM.~   "
116657|NCT01529086|"~     The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident~     prostate cancer, as detected on biopsy, among men who are at increased risk for the disease.~     Dutasteride was compared with placebo for 4 years period. Results showed a relative risk~     reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.~      For REDUCE, biopsies were defined as protocol biopsy if performed at certain timeframes,~     and for cause if outside these predetermined timeframes.~      The investigators propose a post hoc analysis that would allow them to include biopsies that~     really justified a clinical indication, but were excluded from for cause analysis based on~     occurring at either the 2 or 4 year timeframes.~      Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:~      Group 1--dutasteride group biopsied for cause using several definitions: biopsy of~     patients who received dutasteride whose PSA rose from nadir as defined in your own~     protocol,who had a PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% .~     The investigators define these as such because this would reasonably instigate biopsy if the~     clinician had a patient with this scenario in the non-study setting.~      Group 2--placebo group biopsied for cause using several definitions, regardless of~     timeframe but reported at each year of the study and aggregate, with the aggregate number~     being the primary outcome. Thus the investigators would request results of biopsy of~     patients who received placebo To establish differences in biopsy positive rates the groups~     as per each definition listed, to determine if dutasteride decreased the likelihood of for~     cause biopsy compared to not for cause biopsy, and if there is a difference in cancer~     detection risk rate depending on cause vs. no cause in that group compared to placebo.~   "
116658|NCT01529073|"~     Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response~     (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ)~     in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and~     with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to~     compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical~     cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To~     evaluate the virological activity at weeks 4 and 12 after starting the combination of~     Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of~     Peg-IFN plus RBV plus NTZ in HIV/HCV-4-coinfected patients.~      Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II).~      Patients: Individuals with HIV infection and with confirmed chronic HCV infection.~      Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours~     plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks.~      Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing~     the programmed length of treatment.~      Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after~     finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10~     IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe~     adverse events.~   "
116659|NCT01529060|"~     The investigators have learned in past research that the drug phenylbutyrate can decrease~     the amounts of branched chain amino acids and their byproducts in the bloodstreams of~     healthy volunteer patients and also patients with certain disorders of protein breakdown~     including maple syrup urine disease. Through this study, the investigators will try to find~     out how well phenylbutyrate (NaPBA), also known by name brand Buphenyl-TM, decreases BCAA~     and branched chain keto chain acids in the blood of patients with MSUD. The investigators~     hope is that through this research the investigators will be better able to treat these~     patients.~      Subjects with MSUD will take phenylbutyrate (NaPBA) in powder form for a two-week treatment~     period and powder placebo, a substance with no effect on the body, for a two-week treatment~     period. They will be given the same amount of powder and undergo the same laboratory testing~     during both of the two-week treatment periods. The results will be compared once the study~     is over.~   "
116660|NCT01529047|"~     Rates of gambling and substance use behaviors are elevated among emerging adults (ages~     18-24), and these behaviors are individually and jointly associated with a host of negative~     consequences. Evidence suggests there is significant overlap between these behaviors as well~     as comorbidity of associated mental disorders (i.e., pathological gambling and substance~     abuse/dependence). Prior research suggests that a brief in-person delivered personalized~     feedback intervention (PFI) may be an effective method of reducing these behaviors and their~     associated consequences among emerging adults. Thus, the purpose of this study is to~     determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in~     reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample~     of emerging adults, as well as explore potential moderators and mediators of intervention~     efficacy and the longevity of intervention effects (over a period of 18-months).~   "
116661|NCT01529034|"~     The purpose of this study is to examine the long-term safety and tolerability of USL261 in~     the treatment of seizure clusters.~   "
116662|NCT01529021|"~     Millions of children in North America receive an annual flu vaccination, many of whom are at~     risk of experiencing severe distress. Children frequently use technologically advanced~     devices such as computers and cell phones. Based on this familiarity, the investigators~     introduced another sophisticated device - a humanoid robot to- interact with children during~     their vaccination. The investigators hypothesized that these children would experience less~     distress than children who did not have this interaction.~   "
116663|NCT01529008|"~     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of~     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.~     Core decompression is currently the treatment of choice for early stage osteonecrosis of the~     femoral head. This method consists in decompressing the rigid intra-osseous chamber to~     promote revascularization, thus halting progression of the disease and stimulating repair.~     Still this treatment remains highly controversial, since the success rates of the first~     studies have not been repeated.~      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.~     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,~     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells~     recruitment.~      Three studies have indicated the potential clinical benefits of cell-based approaches for~     the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al.~     2004). This is on the basis of these observations that a proprietary population of~     autologous osteoblastic cells (PREOB®) has been developed.~      This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment~     of early stage osteonecrosis of the femoral head. More specifically, the purpose of the~     study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion~     is superior to core decompression/placebo implantation in relieving hip symptoms and halting~     (or reverting) radiological progression of the disease.~   "
116664|NCT01528995|"~     Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising~     condition. It can have a distressing impact and restriction on quality of life.~     Obstetric-related fecal incontinence may occur early after childbirth. Previous obstetric~     injury is a major cause of fecal incontinence in older women.~      When conservative treatment fails, surgery may be an option. Both sacral nerve modulation~     and anal bulking injections is minimal invasive surgical alternatives. Step one in SNM is a~     trial period of temporary stimulation. If the test is successful, the patient can have an~     implantable stimulator (step 2). Transanal submucosal bulking injection of collagen is also~     a possible treatment option and can be an effective treatment for faecal incontinence.~      The purpose of this study is to compare the efficacy of sacral nerve stimulation to anal~     bulking injections in women with fecal incontinence after obstetric sphincter injuries~     (OASIS), through a multicenter blinded, randomized controlled trial.~   "
116665|NCT01528982|"~     The goal of this study is to assess the risk factors for the development of pathological~     gambling.~   "
117210|NCT01521819|"~     This is a pilot, single-center, interventional clinical trial in which subjects will receive~     16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.~   "
116666|NCT01528969|"~     1. The present controlled, randomized, doubleblind study aims to answer the following~          questions:~             -  How will the normal flora be affected by the xylitol consumption?~             -  Will daily consumption of xylitol change the plaque-saliva distribution of the~               mutans streptococci?~             -  The association of the test results will also be compared with the caries status~               at the baseline.~        2. About eighty subjects with MS counts of log CFU 5 or more will be identified and~          invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.~        3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be~          collected before and after gum use.~        4. Studying and quantifying of 16 bacterial species belonging to the normal flora by~          DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral~          flora in general.~   "
116667|NCT01528956|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies genes in samples from younger patients with~     adrenocortical tumor.~   "
116668|NCT01528943|"~     The purpose of this study is to investigate the effect of continuous perioperative infusion~     of prostacyclin on haemostasis and endothelial functionality in patients undergoing major~     abdominal surgery.~   "
116669|NCT01528930|"~     The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in~     human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In~     Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC)~     and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may~     require multiple drugs.~      Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin~     treatment is limited by its systemic route of administration and a lot of adverse events.~     Amikacin inhalation treatment could overcome these limitations and also could be effective~     for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The~     purpose of this study is to determine whether amikacin inhalation treatment is effective in~     patients with MAC infection who experienced treatment failure after standard treatment for~     more than 6 months or with M. abscessus infection.~   "
116670|NCT01528917|"~     This is a Natural History study to characterize key aspects of the clinical course of late~     onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).~   "
116671|NCT01528904|"~     The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with~     clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US)~     parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease~     (AITD).~   "
116672|NCT01528891|"~     To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of~     Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus~     Injection of Dexmedetomidine.~   "
116673|NCT01528878|"~     The purpose of this study is to determine a tolerable dose of radiation delivered by the~     CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).~   "
116674|NCT01528865|"~     Therapy for non-Hodgkin lymphoma (NHL) is in evolution as new molecular pathways and~     targeted therapies are identified. Although most NHLs respond to currently available~     therapies, the majority of patients relapse and many never have a complete response to~     therapy. In the investigators attempts to further understand the pathogenesis of NHLs, the~     investigators have identified and characterized expression of human endogenous retroviruses~     (HERVs) at the DNA, RNA and protein levels in association with the presence of NHLs (and~     other neoplastic diseases). The investigators preclinical evidence suggests a correlation~     with the level of HERV-K (a particular family of HERVs) expression and NHL disease activity,~     leading us to hypothesize that HERV-K expression may contribute to the development of the~     disease and/or to its recurrence. If this hypothesis is correct, then drugs that inhibit~     HERV-K expression may prevent recurrence of disease and/or may provide a novel therapeutic~     approach for NHLs.~      To test this hypothesis, the investigators eventually intend to study the use of~     anti-retroviral therapies in patients with NHL. The investigators in vitro studies have~     demonstrated that HERV-K expression decreases in response to the currently FDA-approved and~     available, anti-HIV drugs, Lamivudine and tenofovir disoproxil fumarate (tenofovir). These~     medications are tolerated well in HIV patients, but it is unknown how the combination of~     Lamivudine and Tenofovir will be tolerated by patients with NHL. To further test the~     investigators hypotheses, the investigators propose the following Specific Aims of the~     current study: (1) To evaluate the tolerability, toxicity and safety of administering~     Lamivudine and Tenofovir in combination to patients with relapsed or refractory NHL; (2) To~     evaluate the effects of the combination of lamivudine and tenofovir on HERV-K plasma viral~     RNA load; and (3) To monitor the response rate of the NHL to treatment with the combination~     of lamivudine and tenofovir.~      The investigators study will recruit adult patients with relapsed or refractory NHL whom the~     investigators have identified as having expression of HERV-K. Volunteer participants will be~     administered the combination of lamivudine and tenofovir and monitored for tolerability,~     toxicity, compliance, changes in viral RNA load and disease response.~   "
116675|NCT01528852|"~     In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine~     cleansing solution on umbilical cord of infants in first 10 days of life results in~        -  Reduction in neonatal mortality (deaths in first 28 days of life)~        -  Reduction in umbilical cord infections (defined by moderate or severe redness of the~          cord) during first 28 days of life~        -  Reduction in umbilical cord infections (defined by pus formation with any degree of~          redness) during first 28 days of life.~      The double blind part of study uses a control preparation without chlorhexidine (CHX) as~     control group while in the sub-study dry cord care group is also evaluated as second~     control. Hypothesis is that CHX group will have lower mortality and umbilical cord~     infections while control group and dry cord group will be similar as shown in a previous~     study in Nepal.~   "
116676|NCT01528839|"~     There is growing evidence that thyroid axis dysfunction may contribute to the~     pathophysiology of bipolar illness. Open-label studies have consistently demonstrated that~     the behavioral expression of bipolar disorder can be modified by a change in thyroid status,~     and in many instances the course of illness is improved through the use of adjunct thyroid~     hormone treatment. Recent evidence emerged from acute intervention studies that add-on~     treatment with supraphysiological doses of levothyroxine is an effective augmenting agent in~     patients with a major depressive episode. The primary goal of this international multicenter~     trial (5 sites) is to determine in a 13-week, randomized, placebo-controlled design (1 week~     single-blind placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety~     of add-on treatment with levothyroxine (300 mcg/d) in combination with mood~     stabilizer/antidepressant therapy in the treatment of patients with bipolar depression. The~     main hypotheses is: treatment with levothyroxine will result in a significantly greater mean~     reduction of HRSD total score and in a higher number of responders and remitters compared to~     placebo treatment. This proposal will build on our pilot data and provide evidence for the~     use of levothyroxine as an effective augmentation strategy in the treatment of bipolar~     depression.~   "
116678|NCT01528813|"~     The study aims to investigate the effectiveness of a single application of Er:YAG laser to~     the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of~     onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial~     respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a~     kind of onychomycosis that does not affect the ungual matrix). The patients will receive~     treatment for 6 months meanwhile they will be followed up to access efficacy of the~     treatment by means of the clearance of nail plate infection.~   "
116679|NCT01528800|"~     The purpose of this study is to see if vitamin K supplementation three times per week~     reduces the progression of coronary artery calcification over 12 months in dialysis patients~     compared to placebo?~   "
116680|NCT01528787|"~     In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized~     to receive Netarsudil (AR-13324) Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle~     (one eye), q.d. (AM) x 7 days. The first dose and last dose will be administered in the~     clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic~     throughout the study.~   "
116681|NCT01528774|"~     The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately~     detected and isolated from the blood of participants with melanoma using novel laboratory~     techniques. Blood samples will be collected from participants with melanoma, and also from~     participants with other solid tumor cancers and healthy volunteers for purposes of~     comparison.~      Relevant information will be collected from participant's medical record and stored in a~     coded manner in a password-protected format. This information will be used to look for~     correlations of research results on blood samples to participant's medical condition. Test~     results will not be given to participants or their physicians. In some cases, CTC may be~     grown for long-term cell lines for further research.~   "
116682|NCT01528761|"~     The purpose of this 12-month study is to compare how well two programs help older adults~     make physical activity a regular habit.~   "
116683|NCT01528748|"~     This study examines the effectiveness of Cognitive Behavioral Analysis System of~     Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults~     who are chronically depressed and alcohol dependent.~   "
116684|NCT01528735|"~     The objective of this trial is to investigate tolerability, safety, pharmacokinetics and~     antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8~     weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.~   "
116685|NCT01528722|"~     Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common~     procedure. This can be performed as an emergency operation when a patient has a complication~     of gall stones such as acute inflammation or pancreatitis. There are several trials which~     demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder~     surgery during a planned elective operation decreases post operative pain. This is the first~     trial to investigate the efficacy of this local anaesthetic during emergency~     cholecystectomy.~   "
116686|NCT01528709|"~     During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to~     bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein~     bypasses themselves develop blockages over time, a process termed saphenous vein graft~     disease. By lowering cholesterol levels in the blood, statin medications are used after~     surgery to prevent the development of atherosclerotic blockages in the vein bypasses.~     Recently, higher doses of statin medications have been introduced, with some studies showing~     that they are more effective than traditional doses when used in heart attack patients.~     Furthermore, laboratory tests have shown that higher doses of statin medications can slow~     the development of atherosclerosis. Despite these benefits, very little is known regarding~     the use of high-dose statin therapy after bypass surgery in humans.~      The goal of this study will be to see if high-dose statin therapy will prevent the~     development of vein graft occlusion during the first year after bypass surgery. Patients~     will be randomized to receive either high-dose statin therapy or conventional moderate-dose~     statin therapy starting within 4 days of surgery and continuing for the duration of one year~     after the operation. The statin medication will be given in capsule form. During the course~     of this study, neither the patient nor the health care team will know which treatment each~     patient is receiving. One year after bypass surgery, a computed tomography (CT) coronary~     angiogram will be performed to evaluate the patency of the vein bypasses.~   "
116687|NCT01528696|"~     Obese patients undergoing cesarean section are at high risk for wound complications, which~     occur in approximately 20% of patients. This is a randomized controlled trial designed to~     determine whether the risk for wound-related complications can be reduced by covering the~     incision with a silver-impregnated dressing in the postoperative period.~   "
116688|NCT01528683|"~     Treatment standard for patients with rectal cancer depends on the initial staging and~     includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III~     tumors, radiochemotherapy should be performed in addition to surgery, preferentially as~     preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in~     surgical approaches, especially the establishment of the total mesorectal excision (TME) in~     combination with sophisticated radiation and chemotherapy have reduced local recurrence~     rates to only few percent. However, due to the high incidence of rectal cancer, still a high~     absolute number of patients present with recurrent rectal carcinomas, and effective~     treatment is therefore needed.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose~     profile and the high local dose deposition within the Bragg peak precise dose application~     and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions~     offer an increase relative biological effectiveness (RBE), which can be calculated between 2~     and 5 depending on the cell line as well as the endpoint analyzed.~      Japanese data on the treatment of patients with recurrent rectal cancer previously not~     treated with radiation therapy have shown local control rates of carbon ion treatment~     superior to those of surgery. Therefore, this treatment concept should also be evaluated for~     recurrences after radiotherapy, when dose application using conventional photons is limited.~     Moreover, these patients are likely to benefit from the enhanced biological efficacy of~     carbon ions.~      In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy~     for recurrent rectal cancer will be determined in the Phase I part, and feasibility and~     progression-free survival will be assessed in the Phase II part of the study.~      Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.~      The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II~     part its progression-free survival.~   "
116711|NCT01528371|"~     Intravenous sedation was used for dealing with transient hypertension, so-called white-coat~     hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety~     effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the~     stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to~     evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in~     white-coat hypertensive dental patients.~   "
116689|NCT01528670|"~     The purpose of this clinical study is to investigate the clinical feasibility and~     effectiveness of off-line Positron-Emission-Tomography (PET) quality assurance for promoting~     the accuracy of proton and carbon ion beam therapy. One main clinical advantage of ion~     therapy over conventional radiation therapy is the excellent conformation of the delivered~     dose to the tumour volume while well sparing the surrounding healthy tissue. However,~     clinical exploitation of this potential to the maximum extent requires in-vivo validation of~     the actual treatment delivery and, in particular, of the ion beam range within the patient.~     Since the primary ions are completely stopped in the target volume as opposed to photon~     radiation, no conventional quality assurance techniques like transmission electronic portal~     imaging can be applied to monitor ion beam therapy. Hence, ion treatment planning currently~     relies on models and experimental data accurately validated in tissue-equivalent targets,~     but no direct verification of the actual treatment delivery and of the ion beam range within~     the patient is possible in standard clinical practice.~      At present, PET offers the unique possibility to monitor the precision of ion irradiation~     in-vivo and non-invasively. The method is based on the detection of the b+-activity which is~     formed as a by-product of the irradiation, i.e. without administration of radio-tracers to~     the patient. A positive clinical impact of in-beam (i.e. during the irradiation) PET~     monitoring has been demonstrated for carbon ion therapy in the pilot project at GSI~     Darmstadt, Germany, and promising clinical data of post-radiation PET/CT imaging have been~     recently reported for passive proton beam delivery in USA and Japan. Therefore, a pilot~     clinical study is hereby proposed at the Heidelberg Ion Therapy Center in order to 1) assess~     the applicability of post-radiation PET imaging to scanned ion beam delivery, 2) identify~     the patient population which may benefit from it and 3) extract population-based information~     on the reliability of the beam range in different tumour locations for all the ion species~     clinically available at HIT.~      The investigated patients are expected to benefit from this study, since in case of detected~     deviations between planned and actual treatment delivery a proper correction could be~     applied in the next irradiation fraction, assuring an overall better treatment than without~     any monitoring. Moreover, site-specific patient-population information on the ion range~     precision at HIT might enable improvement of the CT-range calibration curve as well as safe~     reduction of the treatment margins to promote enhanced treatment plan conformality for full~     clinical exploitation of the promises of ion beam therapy.~   "
116690|NCT01528657|"~     The objective of this study is to intra-individually compare the performances of two~     pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic~     Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare~     ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of~     atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients~     implanted with a pacemaker for Sick Sinus Syndrome.~   "
116691|NCT01528644|"~     Iron deficiency anaemia affects around two billion people worldwide. Food fortification with~     iron is a realistic way to combat this problem. Water soluble forms of iron are considered~     to be more bioavailable than nonsoluble iron compounds. However, the former often cause~     sensory problems when added to foods, while the latter cause fewer problems but are not~     generally well absorbed and are therefore ineffective as fortificants. A potential strategy~     for overcoming this problem is the use of water soluble iron compounds protected by a water~     resistant barrier, which will prevent potential organoleptic changes within fortified foods~     and protect the iron (from oxidation) through the digestion process thus increasing its~     availability. The investigators will use alginate, in the form of alginate beads, as a~     protective barrier for soluble iron gluconate. It has been shown that alginates bind~     divalent and trivalent cations and therefore may be a useful vehicle for soluble iron~     compounds to fortify foods.~      The aim of this project is to measure the effect of alginate on iron absorption from ferrous~     gluconate and assess the potential modulating effect of calcium on iron absorption in the~     presence and absence of alginate.~   "
116692|NCT01528631|"~     The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to~     sucrose in men.~   "
116693|NCT01528618|"~     The present study will be a randomized, control, multicenter phase III study of recurrent or~     metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and~     cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population~     consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical~     radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side~     effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.~   "
116694|NCT01528605|"~     This study is to investigate the protective effects of supplemental lutein and zeaxanthin on~     early age-related macular degeneration (AMD) patients in China.~   "
116695|NCT01528592|"~     Based on studies showing better responsiveness of motor versus cognitive symptoms to~     Parkinson's Disease medication, also known as dopaminergic treatments, the investigators~     hypothesize that comparison of resting state networks in the on versus off medication state~     in Parkinson's Disease patients will show greater effects on brain networks associated with~     motor control.~   "
116696|NCT01528579|"~     Background:~      Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated~     Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and~     personal sufferings there are only a few prospective randomized studies (RCT) in patients~     with chronic WAD, and none of them evaluating return to work, or the role of neck specific~     exercises with or without a combination of a behavioral approach compared with prescribed~     physical activity.~      Aim:~      The general aim of this RCT is to examine what neck-specific training with or without a~     combination with behavioral approach adds to prescribed physical activity of persons with~     chronic WAD with regard to pain intensity, physical and psychological function, health care~     consumption and return to work. Another aim is to study predictive factors of importance for~     a good outcome of rehabilitation.~      Method:~      After informed consent patients in age 18-63 years of age with WAD II-III with more than 6~     months duration will be randomized to one out of the three alternatives of physiotherapy,~     treatment with medical exercise therapy with neck specific exercises (A),treatment with a~     behavioral approach combined with neck specific exercises (B), prescribed physical activity~     (C). Randomisation will be done by the central project leader. 200 patients will be included~     in the study. All physiotherapists engaged in the structured and well described treatment~     will be introduced in the program by the project leader. The measurements with good~     clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24~     months after inclusion into the study. Clinical measurements will be performed by a blinded~     investigator. Background data, disease-specific and generic data will be measured by~     self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected~     from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck~     specific disability and return to work. Cost-effectiveness will be calculated.~   "
116697|NCT01528566|"~     This is the first study to test the effect of Tai Chi on pain from knee osteoarthritis in~     community-dwelling elders with mild cognitive impairment. If Tai Chi is effective in~     reducing pain, clinicians can use it routinely with this population; then elders can~     maintain their functional ability longer, and perhaps delay or prevent long-term care~     admission, and the investigators can save health care dollars.~   "
116698|NCT01528553|"~     In children with excessive knock knees it may be necessary to use guided growth (small~     surgical procedure) so the child outgrows the condition before maturity. A new implant is on~     the market and the investigators compare this implant (8plate) with the old technique~     (staples) in a randomised setup.~      The hypothesis is that the 8plate provides a faster correction rate and that this treatment~     is superior to stapling.~   "
116728|NCT01528150|"~     The purpose of this observational study is the assessment (safety and efficacy) of the St.~     Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™~     System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population~     includes patients with a standard bradycardia pacing indication.~   "
116699|NCT01528540|"~     Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief~     than placebo in patients with chronic pancreatitis.~      Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom~     that brings the patient to clinical attention. Pain in chronic pancreatitis is~     multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension,~     inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical~     allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for~     pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized~     controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage~     gated calcium channel blocking agent) can result in significant reduction of pain in CP.~      In this study, the investigators will study the efficacy of the combination of antioxidants~     and pregabalin in reducing pain and compare that with placebo. The investigators will~     randomize patients with documented chronic pancreatitis with recurrent/persistent pain after~     undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants +~     pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the~     secondary outcomes will be change in the number of painful days, analgesic requirements,~     quality of life and depression scale. Pain score will be quantified by the Izbicki pain~     score and visual analog scale; while quality of life and depression will be measured by the~     EORTC QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A~     vs B will be made by the Chi square test/Fischer Exact and the Student's 't' tests~     respectively and analysis will be done on a intention to treat and per protocol basis. With~     an expected improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a~     presumed 10% drop out rate, the required sample size in each group will be at least 40.~   "
116700|NCT01528514|"~     It is well-established that myocardial infarction (MI) associated with coronary artery~     bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective~     therapies to limit myocardial injury after CABG are lacking. Previous studies have shown~     that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery~     and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion~     injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI~     after CABG, compared to placebo.~   "
116701|NCT01528501|"~     This is an open-label, phase II trial evaluating the antitumor activity and safety of the~     oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589~     three times a week in patients with chemo-refractory HDAC overexpressing.~      metastatic adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett~     carcinoma). One cycle lasts 21 days. A total of 28 patients will be enrolled in this trial.~     In patients experiencing LBH589-related toxicity requiring treatment rest or dose reduction~     dose may be reduced. Subsequent dose adjustment will be permitted based on outcome.~     Treatment will continue until disease progression or intolerable adverse events.~     Subsequently, the patients will be followed-up for one year.~   "
116702|NCT01528488|"~     The epidermal growth factor receptor (EGFR) has become an important target for cancer~     therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an~     important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with~     the encouraging efficacy in NSCLC is the common side effects, of which the most common one~     is the specific papular and pustular acne-like rash which affects mainly the face, scalp,~     and upper torso. But till now, no medicament has been proved effective enough to treat or~     prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable~     activity at the rash prevention in our preliminary study, so the investigators conduct the~     randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC®~     Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.~   "
116703|NCT01528475|"~     This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of~     therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional~     post-resuscitation care. The goal of this trial is to increase the proportion of cardiac~     arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to~     reach the target body temperature within 6 hours of hospital arrival. The investigators~     believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians~     to continue therapeutic hypothermia, and will lead to care improvements across a health~     system.~   "
116704|NCT01528462|"~     The aim of the investigators was to determine whether the immediate management of any~     detected sleep disorders can improve outcomes in patients who have had a transient ischemic~     attack (TIA) or minor stroke. This group of patients is at high risk for having a recurrent~     stroke or TIA, and the investigators would like to investigate new ways of preventing~     potentially avoidable events. The treatment of sleep disorders immediately after a stroke or~     TIA may prove to be a novel method of avoiding future strokes and improving outcomes.~   "
116705|NCT01528449|"~     Both prospective and retrospective (look back) study of blood donors for laboratory evidence~     of babesia microti infection.~      Two laboratory methodologies will be utilized:~        1. - PCR, to look for the presence of B.microti in whole blood~        2. - IFA, to look for significant titers of B.microti antibody~   "
116706|NCT01528436|"~     This randomized controlled study aims to evaluate the efficacy of umbilical cord blood~     therapy for children with cerebral palsy.~   "
116707|NCT01528423|"~     The research is intended to evaluate the short-term reproducibility of the XtremeCT device~     for measurements of peripheral bone density and bone structure in population-based~     volunteers from different age groups and to compare the XtremeCT with current peripheral~     quantitative computed tomography (pQCT) technology. The investigators will also assess the~     correlation between XtremeCT measurements of bone structure with hormones and biochemical~     markers of bone turnover.~   "
116708|NCT01528410|"~     This is a multicentre, open, randomised, and controlled trial conducted in sixty (60)~     patients diagnosed with refractory or recurrent ascites. Patients will be randomised~     (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm~     B-standard of care with evacuation large volume paracentesis. The main aims of the study are~     to determine the paracentesis free survival, defined as the time to the first large volume~     therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of~     cirrhosis-related complications in the group of patients randomized to the ALFApump system~     group, as well as nutritional effects, resource utilisation, patient quality of life and~     survival non-inferiority.~   "
116709|NCT01528397|"~     A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory~     loss which can result in functional disability. This article reports the treatment of the~     thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN.~     Fourteen patients with the thumb PDN defect underwent a new surgical procedure in which the~     pedicled nerve graft was used to bridge nerve defect. For comparison, the investigators also~     collected a consecutive series of 21 patients with thumb PDN defects treated using a~     nonvascularized sural nerve graft. This study was designed to evaluate the efficacy of~     pedicled nerve grafting for PDN defects in the thumb.~   "
116712|NCT01528358|"~     Hypotheses:~        1. In the acute phase of early illness, tissue oxygen saturation and vascular occlusion~          test (VOT) are important adjuncts in differentiating severe critical illness requiring~          ICU admission from patients benefiting from less aggressive therapies (non-ICU~          admission).~        2. An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.~        3. Microvascular reactivity can be measured by means of vascular occlusion test (VOT)~          using non-invasive near infrared spectroscopy (NIRS) to measure tissue Oxygen~          saturation (StO2).~        4. Microvascular reactivity is significantly deranged in patients with early severe sepsis~          and is quantifiably different from non-septic critically ill patients.~        5. Other measures of microcirculatory perfusion ie. sublingual orthogonal polarization~          spectral (OPS) video microscopy, are abnormal and will directionally correlate with VOT~          and StO2 in severe sepsis~        6. In severely septic patients response to therapy can be assessed by VOT and StO2~          monitoring and will correlate with prognosis.~        7. A management protocol incorporating VOT and StO2 monitoring in addition to conventional~          hemodynamic and biochemical parameters as a guide to therapy will result in improved~          outcomes in severely septic patients.~      This project will investigate the use of a non-invasive near infrared light (NIR) device in~     conjunction with brief arm compression to measure the microcirculation in critically ill~     patients. It is know that in patients with overwhelming infections, their blood vessels do~     not respond normally and the NIR device can help measure how abnormal their blood vessels~     are. This type of testing is non-invasive and can be performed repeatedly without harm to~     the patient and may provide an earlier way to determine whether they have overwhelming~     sepsis and also may help to optimize the treatments they receive and better tailor their~     treatments to the degree of blood vessel abnormalities that are found. If our hypotheses are~     correct, this simple non-invasive test could provide a very rapid means of assessing~     patients that could be done more safely and quickly than some of the current methods. This~     would have an important effect to enhance patient safety and improve outcomes in such~     critically ill patients.~   "
116713|NCT01528345|"~     This trial is designed to enroll postmenopausal patients with locally advanced or~     metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or~     radiotherapy, and whose disease has progressed on or after prior endocrine therapy.~      Patients must undergo molecular pre-screening prior to entry.~   "
116714|NCT01528332|"~     The purpose of this study is to determine if the Pain Relief Patch, which shines light of a~     limited wavelength on the painful area of the back, relieves chronic musculoskeletal back~     pain. At the same time, this study will gather information on side effects associated with~     use of the Pain Relief Patch. The study will compare the Pain Relief Patch to a patch that~     is similar in appearance, but which shines a different, presumed nontherapeutic, wavelength~     of light.~   "
116715|NCT01528319|"~     To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for~     dislocation of shoulder~   "
116716|NCT01528306|"~     This is a pilot study designed to see if HP802-247, an investigational treatment with living~     human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis~     Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also~     be assessed.~   "
116717|NCT01528293|"~     This is a prospective, randomized, comparative interventional human subject trial. Patients~     with a chronic venous ulceration of the lower extremity will be enrolled into this study.~     These wounds must be recalcitrant to the standard treatment regimen. There are a total of~     two arms in this study. One group will be randomly assigned to receive Vacuum Assisted~     Closure (V.A.C. or VAC) by means of the ActiV.A.C. + Compression therapy group consisting of~     the application of this device along with compression therapy. The other group will be~     randomly assigned into compression therapy only group. A total of 60 subjects will be~     enrolled into this 6 week study. There will be a 2 week run-in period (prior to the onset of~     the intervention) to ensure that the wound has not healed greater than 35% prior to~     intervention and randomization. Wounds that heal within the 6 week trial period will have an~     additional confirmatory visit 2 weeks after healing was identified.~      If within the 6 week intervention period the wound bed is determined to be ready for a Split~     Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT), the surgery or~     clinic application will be scheduled within 4 weeks. Subjects deemed not to be a surgical~     candidate, will have Bio-engineered Alternative Tissue (BAT) application in the clinic. This~     includes patients who are medically unstable to receive a medical clearance for surgery or~     otherwise not a candidate for Split Thickness Skin Graft (STSG) surgery (e.g. donor site~     skin is compromised). During this period between the scheduled STSG surgery or BAT~     application, the subjects will continue within the assigned treatment group. A confirmatory~     visit will also occur 2 weeks after the application of a Split Thickness Skin Graft (STSG)~     or Bio-engineered Alternative Tissue (BAT).~      Patients diagnosed with a chronic venous ulceration will be assessed for study eligibility~     during their initial clinical evaluation. Patients who meet the eligibility requirements~     will be asked to enroll into the study (see Subject Recruitment). Subjects will be asked to~     sign the informed consent form and receive a copy of the informed consent.~   "
116718|NCT01528280|"~     The purpose of this study is to access whether shift workers (morning, afternoon or night)~     vaccinated against hepatitis A would have some humoral and cellular response impairment.~   "
116719|NCT01528267|"~     The prupose of this study is to determine the feasibility, effectiveness, and safety of~     injecting blood into the airways to cause lung volume reduction in people with severe~     emphysema.~   "
116720|NCT01528254|"~     The purpose of this study is to determine whether the initiation of a vildagliptin plus~     metformin combination regimen would result in more durable glycemic control than metformin~     monotherapy in treatment-naïve patients with T2DM.~   "
116721|NCT01528241|"~     This study is designed to characterize the regional distribution of [11C] ABP688 in brain by~     positron emission tomography (PET).~   "
116722|NCT01528228|"~     Following standard of care procedures for arthroscopy knee surgery it is anticipated that~     Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and~     improve functional outcomes.~   "
116723|NCT01528215|"~     The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to~     implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate~     up to five years after implant loading. The hypothesis is that there will be no clinically~     relevant differences in marginal bone level alterations one year after functional loading.~   "
116724|NCT01528202|"~     The aim of this investigation was to examine the effects of tart Montmorency cherry juice on~     urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled,~     cross-over design.~   "
116725|NCT01528189|"~     Despite improvements in surgical techniques and perioperative care, the high incidence of~     postoperative surgical site infections remains a major problem in patients undergoing major~     abdominal surgery (liver, pancreatic and colorectal surgery).~      Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of~     insulin combined with dextrose titrated to clamp blood glucose between 4 and 6 mmol/L, we~     successfully established and preserved normoglycemia during the perioperative period. Our~     objective of this study is to determine if the maintenance of perioperative normoglycemia by~     a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical~     site infections following abdominal surgery (liver, pancreatic and colorectal surgery).~   "
116726|NCT01528176|"~     To determine whether or not chronic kidney disease (CKD), stages III—V and ESRD , is~     associated with altered vitamin D metabolism related to fibroblast growth factor-23 (FGF-23)~     stimulation of Cyp24 and whether they have resistance to elevations of 25 Hydroxyvitamin D~     (25(OH)D3) after cholecalciferol supplementation.~      To determine if such resistance is related to enhanced catabolism of (25(OH)related to~     elevated levels of FGF-23.~   "
116727|NCT01528163|"~     In this clinical trial, the investigators want to know if cabazitaxel is more effective than~     methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head~     and neck in palliative treatment.~   "
116729|NCT01528137|"~     This phase I trial studies how well talactoferrin works in treating patients with relapsed~     or refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer.~     Biological therapies, such as talactoferrin, may stimulate the immune system in different~     ways and stop tumor cells from growing~   "
116730|NCT01528124|"~     This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and~     tolerability of the study drug in healthy people and investigate how much of the study drug~     gets into the blood stream and how long it takes the body to get rid of it. Information~     about any side effects that may occur will also be collected.~   "
116731|NCT01528111|"~     This Phase 1/2a study is intended to assess the safety, tolerability, and effects on~     intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered~     topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular~     hypertension.~   "
116732|NCT01528098|"~     The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus~     bisacodyl versus PEG alone for bowel preparation in hospitalized patients.~   "
116733|NCT01528085|"~     The goal of this trial is to evaluate the efficacy and the tolerance of the combination of~     nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy~     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a~     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be~     used in this trial with the addition of nilotinib as concomitant therapy during induction,~     consolidation and maintenance. The patients will be prospectively monitored for minimal~     residual disease and bcr-abl tyrosine kinase domain mutations.~   "
116734|NCT01528072|"~     The purpose of this study is to assess the safety and fusion rates following posterior~     lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to~     literature control.~   "
116735|NCT01528059|"~     Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be~     varied by different gastric-small intestine reconstruction used in the procedure. There are~     reports that Roux en Y reconstruction may give a better result. The purpose of this study is~     to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid~     with type 2 diabetes.~   "
116736|NCT01528046|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project~     Coordinator, but will not be recruiting locally.~      The purpose of this study is to evaluate the tolerability and safety of escalating doses of~     metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with~     recurrent and refractory solid tumors.~   "
116737|NCT01528033|"~     The Institute for Research in Operative Medicine as part of the Private University of Witten~     /Herdecke and Kinetic Concepts Incorporated are performing a clinical study to evaluate the~     efficacy of Vacuum Assisted Closure® (V.A.C.®) Therapy for the treatment of postsurgical~     abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous~     tissue that permeates the internal organs must be intact.~      Background of the study is the decision of a german authority, that is responsible for the~     reimbursement of medical therapies, (Joint Federal Committee of Germany) that Vacuum~     assisted closure therapy is inadmissible to be a standard benefit of health insurance~     companies in Germany.~      Basis for this decision have been reports of the Institute for Quality and Economic~     Efficiency in the Healthcare System, which showed an insufficient state of evidence~     regarding the efficacy of negative pressure wound therapy for the treatment of acute and~     chronic wounds.~      This study will be performed in several hospitals and countries to compare the efficacy of~     Vacuum Assisted Closure®-therapy with the methods of standard conventional wound therapy~     according to the existing hospital standard.~      Main outcome measure is the time which is needed to achieve a complete and stabile wound~     closure. Furthermore the therapy options will be examined regarding several other clinical,~     safety, patient reported and economic parameters.~      Patients will be assigned equally and by chance to both treatment groups. Study participants~     as well as the attending doctors and nurses will be informed about the assignment to the~     respective treatment arm.~      The primary outcome measure (time until complete and confirmed wound closure) and some of~     the secondary parameters like reappearance of the wound and the development of the wound~     size over time, examined within an active study treatment time of 42 days, will be~     photographed and analysed under the use of a central computer system. The central analysing~     personal will not be informed about patient details or therapy allocation.~      Based on already performed studies and the experiences of clinical practise V.A.C.®-therapy~     is suspected to be faster in achieving a complete and stabile wound closure than standard~     conventional wound therapy when used for the treatment of postsurgical abdominal wound~     healing impairments after surgery. Furthermore Vacuum Assisted Closure®-therapy is believed~     to be an effective and safe treatment option for abdominal wound healing impairments after~     surgery for inpatient as well as for outpatient care.~      belly wounds Patients with at first closed belly wounds with wound healing disorder in the~     postoperative course after surgery without an opening of the underlying layer of fibrous~     tissue are eligible to be included in the trial if the diagnosis of a wound healing~     impairment in the postoperative course is manifested as a wound with spontaneous dehiscence,~     a wound that requires an active reopening of the suture by the treating physician or a wound~     that cannot be closed by primary intention and requires further treatment to achieve~     permanent closure.~      Study participants will be selected and enrolled within clinical surgical departments which~     provide the respective personal, structural and scientific background for the conduction of~     the trial project.~      Trial therapy will be started in-hospital and may be continued in ambulatory care. It is~     very important to examine the therapy options also in the ambulant care setting thus study~     participants with good health who are able to continue the specific wound treatment in~     ambulant should be transferred to the ambulant service as soon as possible.~      The results of the study will be provided until the end of 2014 to make a contribution to~     the final decision of the Joint Federal Committee about Vacuum Assisted Closure® (V.A.C.®)~     Therapy to be a standard benefit of health insurance companies in Germany for inpatient and~     / or outpatient care.~   "
116738|NCT01528020|"~     Suicide is the third leading cause of death among adolescents in the US yet there is a~     paucity of research on effective treatments for this population. The primary aim of the~     research described in this application is to evaluate the efficacy of dialectical behavior~     therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal~     adults of reducing the incidence, frequency and medical risk of suicide attempts and~     non-suicidal self-injuries among individuals meeting criteria for borderline personality~     disorder (BPD). While DBT is widely used in the community with suicidal adolescents,~     particularly those with difficulties characteristic of BPD such as poor emotion regulation~     and impulse control, no randomized trial of DBT with suicidal adolescents has ever been~     conducted. And, while non-randomized trials indicate that the intervention is both safe and~     effective, without a randomized trial the investigators simply do not know whether DBT for~     suicidal adolescents is efficacious or not. Given the severity of the problem and the lack~     of alternative treatments for high risk adolescents, addressing this question is of great~     importance. The second aim of the research is to analyze mediators of reduced suicidal and~     self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los~     Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both~     treatments include 6 months of individual and group treatment and adolescents and a parent~     complete 5 assessments over a 1-year period.~   "
116739|NCT01528007|"~     The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as~     combined with CBT-intervention in the treatment of pathological gambling (PG). The study~     period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to~     participate to this placebo-controlled double-blind trial.~   "
116740|NCT01527994|"~     Current treatments for opioid addiction would benefit by the addition of a non-opioid based~     treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1)~     receptor is involved in opioid reward and withdrawal. This study proposes to study a~     potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist~     aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological~     characteristics of opioid addiction, and what is known of the currently employed treatments,~     the investigators propose that the therapeutic mechanism of any potential opioid addiction~     treatment medication must include the ability to reduce opioid withdrawal. This is of~     particular importance during treatment initiation (eg. detoxification). In addition, for~     long-term treatment and relapse prevention, it is important to manage drug craving and~     inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the~     investigators propose to study aprepitant using human models of opioid withdrawal, craving~     and acute opioid reward and reinforcement. The investigators will also include a~     neuro-economics choice procedure paradigm.~   "
116741|NCT01527981|"~     This study is a pilot behavioral intervention trial, designed to initially examine cognitive~     behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression~     and poorly controlled type 1 diabetes.~   "
116742|NCT01527968|"~     TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there~     is no literature available comparing the two in total knee arthroplasty (TKA). The~     investigators want to determine if TXA or EACA compared with placebo are effective and safe~     for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.~   "
116743|NCT01527955|"~     The purpose of this study is to determine how effective Kelee meditation is in improving~     stress, anxiety, and depression.~   "
116761|NCT01527721|"~     Primary objective of this study was to assess the impact of the two prevalent therapeutic~     options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on~     both anterior and posterior corneal High order aberations (HOAs).~   "
116744|NCT01527942|"~     Bariatric patients usually require the use of either intravenous or oral opioid medications.~     The use of opioids, however, is often associated with side-effects such as nausea, sedation~     pruritus, urinary retention and respiratory depression with often delay patient discharge.~     This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to~     determine if this will decrease the use of opioids post-operatively for pain management in~     morbidly obese patients undergoing laparoscopic bariatric surgery.~   "
116745|NCT01527929|"~     Primary Objective:~      - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics~     of cabazitaxel~      Secondary Objective:~      - To assess the safety of cabazitaxel in patients with various degrees of renal impairment~   "
116746|NCT01527916|"~     This is an efficacy and safety study evaluating a new treatment for subjects with mild to~     moderate Alzheimer's disease.~   "
116747|NCT01527903|"~     The purpose of this study is to compare propofol-remifentanil sedation with~     midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in~     the ICU, as well as the incidence of delirium. Primary end-points were weaning time and~     extubation time, and secondary end-points were the incidence of delirium and length of stay~     in the ICU.~   "
116748|NCT01527890|"~     In this retrospective study, the investigators examined incidence and risk factors of~     postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous~     patient-controlled analgesia (IV-PCA).~   "
116749|NCT01527877|"~     This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as~     therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.~   "
116750|NCT01527864|"~     A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out.~     Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control~     group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until~     disease progression or death.~   "
116751|NCT01527851|"~     Introduction: Currently, bariatric surgery appears to be the most effective treatment to~     improve the health of morbidly obese population. However, the massive weight loss induced by~     this intervention can create excess loose skin in various parts of the body contributing to~     the feeling of failure in their desire to feel better in some patients. Several studies show~     that people are once again disappointed and dissatisfied with their body appearance due to~     the mass of unsightly loose skin that disrupts their quality of life. However, very few~     studies have focused on the barriers that this excess skin could create in everyday physical~     activity. The aim of the investigators pilot study is to assess the impact of excess skin on~     the practice of physical activity in women who underwent bariatric surgery and evaluate if~     there is a relationship between physical activity and the level and location of excess skin.~     Also, the investigators will explore, the benefits of plastic surgery in patients who had~     this intervention.~      Materials and methods: About twenty women who underwent bariatric surgery and a dozen who~     had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight~     loss post bariatric and plastic surgery, motivational stage on the practice of physical~     activity, usual practice of physical activity, functional and physical ability, perceived~     benefits and barriers of physical activity, self-esteem and quality of life will be~     assessed. After analyzing the results, a group discussion will be established to further~     evaluate the impact of excess skin on the practice of physical activity. The evaluation will~     be identical for monitoring the effects of plastic surgery but the discussion group will~     also address the benefits and satisfaction related to plastic surgery.~      Expected results: Excess skin could be a barrier to physical activity by limiting the~     functional and physical capacity. Thus, plastic surgery could improve the practice of~     physical activity with a direct improvement of functional discomfort, the subjects'~     motivation to be physically active, perceived benefits and barriers to physical activity,~     self-esteem and quality of life.~      Issue project: This pilot project will generate data that will allow us, depending on the~     relevance of the results, to continue the investigators investigation with a larger cohort.~   "
116752|NCT01527838|"~     This trial is a prospective, open-label, single-arm trial of the safety of a single~     FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity~     conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects~     will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.~   "
116753|NCT01527825|"~     The overall aim of this project is to evaluate the safety and immunogenicity of 3 different~     dosing options of trivalent influenza vaccine (TIV) vaccination of HIV-infected pregnant~     women: single dose, double dose (at same time point) and two-doses (1 month apart).~   "
116754|NCT01527812|"~     The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound~     guided femoral nerve block using the following endpoints: circumferential spread, anterior~     or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for~     operative fixation of fractured neck of femur.~   "
116755|NCT01527799|"~     The purpose of this study is to use comprehensive exercise testing to examine causes of~     exercise limitation in children and young adults with sickle cell anemia.~   "
116756|NCT01527786|"~     Postpartum depressed women suffer from functional impairment in their mood, thoughts,~     cognition and physical well being leading to poor motivation, bonding difficulties,~     decreased productivity, conflict and neglect. Moderate/ severe depression responds best to a~     combination of antidepressants and counseling. This study will estimate the proportion of~     women who return to functionality after treatment with Desvenlafaxine and examine the~     differential impact of change in depression and anxiety symptoms on functionality over~     twelve weeks. Depression and anxiety symptoms will be monitored through six mood~     questionnaires; functional recovery will be monitored through a simple self-report~     questionnaire at each visit.~   "
116757|NCT01527773|"~     TOPDOCS is a prospective cohort study including COPD patients from currently six study~     centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up~     annually for at least 3 years. Yearly assessments will include a detailed patient history,~     quality of life and activity questionnaires, history of exacerbations, lung function,~     measurements of exercise capacity, measurements of vascular function, exhaled breath~     analysis and blood sampling. The overall objective of the project is to establish a~     meticulously characterized cohort of COPD patients living in Switzerland in order to allow~     high quality research on the pathogenesis, treatment and complications of COPD. The specific~     aim of the project is to determine clinically relevant COPD phenotypes and biological~     factors influencing vascular function in COPD patients.~   "
116758|NCT01527760|"~     To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential~     Hypertension by conducting clinical trial in moderate hypertensive patients for a period of~     six weeks.~   "
116759|NCT01527747|"~     The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes,~     on fasting and post-meal blood triglyceride (blood fat) levels.~   "
116760|NCT01527734|"~     The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose~     comparison with a open-label, crossover, formulation comparison.~   "
117376|NCT01519661|"~     This study assessed the long term safety data for the use of tobramycin inhalation powder in~     patients suffering from cystic fibrosis who have a chronic pulmonary infection with~     Pseudomonas aeruginosa.~   "
116763|NCT01527695|"~     This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or~     female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a~     clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20~     patients to complete this study.The study will evaluate the effect of 8 weeks treatment with~     AZD3241 on microglia activation as measured via PET examinations.~   "
116764|NCT01527682|"~     Objectives:~      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a~     selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to~     surgical procedures. Safety will be assessed, too.In the first version of the protocol 96~     eyes were forecasted to complete the enrolment. The protocol was then amended and now to~     complete the study 68 eyes should be included.~   "
116765|NCT01527669|"~     The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin~     acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet~     after single oral administration in healthy subjects.~   "
116766|NCT01527656|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.~   "
116767|NCT01527643|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.~   "
116768|NCT01527630|"~     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence~     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese~     subjects.~   "
116769|NCT01527617|"~     The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical~     trial is to investigate the potential antioxidant benefits of a cranberry beverage. The~     investigators hypothesize the chronic consumption of this beverage will improve indices of~     oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators~     also hypothesize that these benefits will be particularly evident following an oral glucose~     tolerance test.~   "
116770|NCT01527604|"~     The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to~     determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve~     biomarkers of inflammation in older, obese adults.~   "
116771|NCT01527591|"~     The purpose of this study is to determine the safety and long-term immunogenicity of the~     13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant~     recipients.~   "
116772|NCT01527578|"~     The University of California, San Francisco (UCSF) Simons Variation in Individuals Project~     (Simons VIP) is currently recruiting healthy controls for a study aimed at better~     understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting~     functional and structural imaging, neuropsychological evaluation, genetic testing, and~     neurologic exams in healthy individuals to compare with findings in autism spectrum~     disorder.~   "
116773|NCT01527565|"~     This trial is conducted in Africa. The aim of this trial is to investigate the~     bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.~   "
116774|NCT01527552|"~     This trial is conducted in Africa. The aim of this trial is to investigate the~     bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.~   "
116775|NCT01527539|"~     This trial is conducted in North America. The aim of this trial is asses the long term~     safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes~     who had participated in the BIAsp-1237 trial.~   "
116776|NCT01527526|"~     Objective:~      The purpose of this study is to determine the etiology of the weight increase in~     Depot-medroxyprogesterone Acetate (DMPA) users.~      Method:~      Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users~     of a non hormonal method follow for two years. Will be included only women who never used~     DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of~     corporal fat, lipids profile and glycemia parameters every six months. Thirty women and~     their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the~     resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial~     evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples.~     The metabolic alterations should elucidate the etiology, and the beginning of the sub~     clinical cardiovascular disease should be shown/discarded with the arterial evaluation.~   "
116777|NCT01527513|"~     To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo~     as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset~     seizures.~   "
116778|NCT01527500|"~     The amendment is designed to test the safety and efficacy of lower and higher doses of~     Intravitreal (IVT) LFG316 using single and 18 successive monthly injections in patients with~     geographic atrophy (GA). The study will also provide information on the safety,~     tolerability, serum concentrations and pharmacodynamics of single and multiple IVT doses of~     LFG316.~   "
116779|NCT01527487|"~     The investigators propose a randomized phase II study evaluating the pCR and toxicity~     profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC)~     as neoadjuvant therapy for locally advanced HER2-negative breast cancer.~   "
116780|NCT01527474|"~     This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as~     monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase~     of the study will consist of an 8 week treatment phase. Treatment of eligible participants~     will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based~     on the presence of depressive symptoms and side effects up to a maximum of 20mg/day.~      Study objectives are:~        1. to investigate the efficacy of escitalopram in the treatment of PPD.~        2. to assess the effects of escitalopram on patients quality of life.~   "
116781|NCT01527461|"~     The purpose of this study is to show that dogs are able to detect cancer in sweat samples.~     This potentially would be the base for developing a new efficient, non invasive and~     inexpensive diagnosis tool of lung cancer.~   "
116835|NCT01526733|"~     The purpose of this study is to evaluate consistency of accelerated insulin absorption and~     onset-of-action and shortened duration of action for bolus insulin infusions after~     pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20])~     injection at the time of infusion set insertion compared to sham injection.~   "
116782|NCT01527448|"~     This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy~     and safety of Quetiapine XR given as monotherapy in the treatment of non-lactating,~     post-partum women diagnosed with Bipolar II Disorder. Subjects will need to visit the study~     doctor up to 8 times over a period of 9 weeks.~      During the study period, subjects will be receiving a treatment with Quetiapine XR. The~     starting dose of quetiapine that subjects will receive is 50mg. The response to the~     treatment of quetiapine will determine whether the study doctor will increase the dosage of~     the subject's quetiapine. If the study doctor increases the quetiapine during the study, the~     maximum dosage allowable during the study is 300mg.~   "
116783|NCT01527435|"~     The purpose of this study is to evaluate the fact that 20 milligrams per day of oral~     Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative~     age related macular degeneration (ARMD) undergoing combination therapy with intravitreal~     Bevacizumab (Avastin), intravitreal Dexamethasone and PDT laser photocoagulation and~     improves anatomic and visual outcome compared to patients not receiving oral Zeaxanthin.~     Study patients will be taking AREDS(PreserVision) and multivitamins (Centrum Silver); in~     addition one-half of the patients will receive 20mg of oral Zeaxanthin.~   "
116784|NCT01527422|"~     We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim~     (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to~     administer the chemotherapy courses every 2 weeks with the practical advantage of requiring~     only one dose of PEG-filgrastim instead of daily doses of G-CSF.~   "
116785|NCT01527409|"~     The Objectives of this study is~        1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of~          participating in tailored program (Health Partnership Program) for 24 weeks~        2. To evaluate the efficacy for quality of life, life satisfaction, health leadership,~          anxiety, depression, impact of event, social support, cancer belief as a result of~          participating in tailored program (Health Partnership Program) for 24 weeks~        3. To assess the efficacy of such intervention compared with usual care in cancer patients~   "
116786|NCT01527396|"~     The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node~     metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial~     cancer.~   "
116787|NCT01527383|"~     This is a randomized, double-blind, placebo-controlled study to assess the safety and~     tolerability of V212 when administered to adults with autoimmune disease.~   "
116788|NCT01527370|"~     This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults~     in India.~   "
116789|NCT01527357|"~     The primary objective of the study is to demonstrate the superiority of Fibrocaps plus~     gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects~     with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue~     surgery.~      This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial~     that will be conducted at clinical trial sites in the European Union and United States.~   "
116790|NCT01527344|"~     Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in~     transplanted hearts which is a significant cause of morbidity and mortality. The broad~     objective of this research study is to advance our ability to diagnose as early as possible~     the presence of CAV and to non-invasively predict those patients at increased risk of CAV~     with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging~     technique using an optical analog of ultrasound with a resolution 10 times greater~     resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in~     peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and~     peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a~     precursor of atherosclerosis) which has been validated in non-transplant patients. Patients~     scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester,~     Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached~     on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial~     function testing. The investigators aim to 1) compare the frequency and plaque type of CAV~     as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and~     severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function~     scores.~   "
116791|NCT01527331|"~     The purpose of this study is to compare the decision making of hospitalized subjects with~     advanced cancer having a verbal discussion about CPR compared to subjects using a video.~   "
116792|NCT01527318|"~     Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the~     PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle~     weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due~     to cardiac failure. Not much is known about the underlying mechanisms, though recently it~     was discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased~     mitochondrial function, lipid accumulation and cardiac failure resulting in death at young~     age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced~     mortality rates in these mice. These findings may have a major impact for patients with~     NLSDM if these results can be translated to humans. Therefore, the investigators would like~     to evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac~     function in patients with NLSDM.~      Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements~     will be performed prior to the study and after treatment. Cardiac and muscular lipid~     accumulation, cardiac function, mitochondrial function and insulin sensitivity will be~     assessed during these baseline measurements.~   "
116793|NCT01527305|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute~     schizophrenia (that is within past 4 weeks).~   "
116794|NCT01527292|"~     The purpose of this study is to determine pain control rate (Percentage of patients in each~     arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months~     post-treatment.~   "
116795|NCT01527279|"~     The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial~     was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation~     during observation sinus rhythm.~   "
116892|NCT01525992|"~     In this study the investigators aim to evaluate the impact of a community pharmacy-based~     program to educate type 2 diabetic patients about medications, life style and self-care.~   "
116796|NCT01527266|"~     Several studies have reported that carbohydrate (CHO) ingestion can improve performance~     during exercise of short duration (less than 60 min). However, there is no apparent~     metabolic explanation for this observation because endogenous CHO stores should not be a~     limiting factor during short duration exercise. Nonetheless, several groups have attempted~     to investigate CHO administration during short duration exercise with varying results. When~     CHO was administered intravenously, no performance effect was observed despite greater~     plasma glucose availability (5). Therefore, it was suggested that during exercise of short~     duration, exogenous CHO ingestion may exert its ergogenic effect by action through the~     central nervous system, possibly mediated by glucose receptors in the mouth. The latter has~     been investigated using a CHO-mouth rinse, whereby the CHO solution is spat out to remove~     any influence of the gut on exogenous CHO oxidation or performance. Using this rinse,~     studies have demonstrated results both for (5, 16), and against (1, 19) any improvement in~     short duration exercise performance when compared with a placebo. The discrepancy in the~     findings may be due to testing subjects in the fed (1) or fasted-state (5), when liver~     glycogen stores may be compromised. However, no study has tested subjects in both the fasted~     and fed-state using a CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse~     is only effective at improving short duration exercise performance when subjects are in the~     fasted, compared with the fed-state. The investigators will test the hypothesis that~     CHO-mouth rinse improves performance in the fasted-state only compared with a placebo-rinse.~   "
116797|NCT01527253|"~     The study evaluates the effect of a diet combining two different functional concepts on~     markers associated to cardiometabolic risk. The functional concepts are selected on the~     basis of their reported ability to influence the inflammatory tonus. It is hypothesized that~     the medium-term consumption of a diet combining low GI-prebiotic foods may positively~     influence various biomarkers associated with the risk for developing metabolic syndrome and~     cardiometabolic disease. Also, the combination of functional mechanisms are expected to~     result in synergistic effects.~   "
116798|NCT01527240|"~     The main objective of this study is to determine whether a single injection of CsA after~     intravenous thrombolysis can significantly decreased the volume of cerebral infarction at~     day 30 ± 15 assessed with Flair MRI.~      Secondary objectives are to determine whether a single injection of CsA after intravenous~     thrombolysis is safe and effective regarding to death and disability.~   "
116799|NCT01527227|"~     The research will examine effects of personal, familial, societal and intergenerational~     characteristics on parentification, the effects of parentification on the quality of life of~     the child and what encourages a better quality of life. This research will include 130~     children between the ages of 10-18 who live with at least one parent who struggles with~     serious mental illness in a comparison to 130 children of the same socio-demographic~     characteristics raised by parents from a non-clinical population. The differences between~     these two populations with regard to parentification, quality of life, social support and~     fairness will also be examined. The parents and the children will fill out questionnaires.~     The research group will be recruited from rehabilitation services, mental health clinics,~     psychiatric hospitals and social welfare departments with sampling method. The comparison~     group will be recruited from schools. This research broadens the knowledge of the causes and~     the repercussions of parentification among children of parents who struggles with serious~     mental illness in comparison with children raised by parents from a non-clinical population.~     Few studies have examined children of the mentally ill in Israel, and there are none which~     examined parentification.~   "
116800|NCT01527214|"~     Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted~     through General Practice, sadly it tends to take a relatively long time from first time the~     patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are~     common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm~     symptoms. On average a General Practitioner in Denmark sees only one patient with newly~     diagnosed lung cancer a year and the doctor will therefore get the clinical experience that~     when they refer a patient, test often come out negative and they therefore fail to refer and~     delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is~     conventional chest X-ray, which unfortunately is inefficient in many cases, while CT~     scanning has proven effective even for small tumors.~      Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of~     cancer fast-track and detection of suspected lung cancer can be optimized in relation to~     interpretation of symptoms and subsequent referral practices and radiological investigation.~     2) General Practitioners with special training can change the referral routines and 3)~     direct access to fast CT scanning leads to earlier diagnosis of lung cancer.~      Methods: The first part of the study is a register-based study of lung cancer patients' road~     to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part~     of the study is a clinical, randomized study of the effect of referral directly to fast~     chest CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of~     fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects,~     including patient groups with increased delay.~      The study will contribute new knowledge to the way GP's interpret symptoms, the way they~     refer their patients when they suspect cancer, their use of diagnostic imaging and cancer~     fast-track pathways. It will then provide a unique opportunity to create the necessary~     knowledge about the effects of direct referral to fast CT scan and it might be a decision~     aid whether to open for direct CT scan in General Practice for a group of patients.~   "
116801|NCT01527201|"~     The purpose of this randomized controlled trial is to determine the effectiveness of~     treating cartilage lesions found during knee arthroscopy.~   "
116802|NCT01527188|"~     The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite~     (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score~     during the allergen chamber challenge before and after 6 months of treatment.~   "
116803|NCT01527175|"~     The subclavian vein (SCV) is often the preferred site for central venous access.~     Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC)~     approach have been proved to be useful in children. The investigators compared the success~     rate, number of attempts, time tocatheterization, and complication.~   "
116804|NCT01527162|"~     This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day~     walking activity and life participation of ambulatory children with cerebral palsy. The~     investigators propose that SAFO have not effect on levels of walking and life participation~     versus not wearing the SAFO.~   "
116820|NCT01526928|"~     Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)~     that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while~     sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic~     (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD)~     and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and~     efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR~     mutation.~   "
116805|NCT01527149|"~     This phase II trial studies how well ofatumumab in combination with cyclophosphamide,~     doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with~     ofatumumab in combination with cytarabine and methotrexate works in treating patients with~     newly diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, may~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone,~     cytarabine, and methotrexate, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ofatumumab together with alternating regimens of combination chemotherapy~     may kill more cancer cells.~   "
116806|NCT01527136|"~     This phase I trial studies the side effects and best dose of entolimod in treating patients~     with locally advanced or metastatic solid tumors that cannot be removed by surgery.~     Biological therapies, such as entolimod, may stimulate the immune system in different ways~     and stop tumor cells from growing.~   "
116807|NCT01527123|"~     This is a Phase 1, single-center, open-label study to evaluate the pharmacokinetics of the~     BPO metabolites benzoic acid and hippuric acid with 7-day repeat application of GSK2585823~     in subjects with acne vulgaris~   "
116808|NCT01527110|"~     This study will be an open-label, multi-center, single arm study to evaluate the safety and~     efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with~     laboratory confirmed influenza infection.~   "
116809|NCT01527097|"~     Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may~     be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and~     involvement of cells of the immune system. Atherosclerosis is frequently treated by statins~     (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce~     inflammation. Some new evidences also suggest that therapy with statins may improve~     psoriasis skin disease.~      The current study aims are to evaluate whether a strong statin named Atorvastatin can~     improve psoriatic skin disease and functioning of the arteries. The study also aims to~     evaluate if the activity of these two diseases are related to levels of common inflammatory~     biomarkers (substance in blood) and whether Atorvastatin can change their levels.~   "
116810|NCT01527084|"~     1. To determine the appropriate timing of surgical intervention after Percutaneous~          Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).~        2. To see the change in morbidity and mortality after changing the interval of surgery~          after PCD~   "
116811|NCT01527058|"~     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed~     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,~     biodistribution, safety and diagnostic performance of 68Ga-BNOTA-PRGD2 in healthy volunteers~     and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg~     BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer~     patients. Visual and semiquantitative method will be used to assess the PET/CT images.~     Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests,~     serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be~     collected from the volunteers. Adverse events will also be observed in the patients.~   "
116812|NCT01527045|"~     This phase II trial studies how well donor atorvastatin treatment works in preventing severe~     graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC)~     transplant in patients with hematological malignancies. Giving low doses of chemotherapy,~     such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of~     cancer cells and may also prevent the patient's immune system from rejecting the donor's~     stem cells. The donated stem cells may replace the patient's immune cells and help destroy~     any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells~     from a donor can also cause an immune response against the body's normal cells (GVHD).~     Giving atorvastatin to the donor before transplant may prevent severe GVHD.~   "
116813|NCT01527032|"~     High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy~     for systemic AL amyloidosis (AL), but treatment-related mortality (TRM) has historically~     been high. The investigators performed a phase II trial of risk-adapted SCT followed by~     adjuvant dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve~     response rates. Patients with newly diagnosed AL involving £2 organ systems were assigned to~     MEL 100, 140, or 200 mg/m2 with SCT, based on age, renal function and cardiac involvement.~     Patients with persistent clonal plasma cell disease 3 months post-SCT received 9 months of~     adjuvant thal/dex (or dex if there was a history of deep vein thrombosis or neuropathy). TRM~     was 4.4%. Thirty-one patients began adjuvant therapy, with 16 (52%) completing 9 months of~     treatment and 13 (42%) achieving an improvement in hematological response. By~     intention-to-treat, overall hematological response rate was 71% (36% complete response) with~     44% having organ responses. With a median follow-up of 31 months, 2-year survival was 84%~     (95% confidence interval: 73%, 94%). Risk-adapted SCT with adjuvant thal/ dex is feasible~     and results in low TRM and high hematological and organ response rates in AL patients.~   "
116814|NCT01527019|"~     This study is to assess if the efficacy of cephalosporin is similar to the efficacy of~     norfloxacin in the acute cystitis treatment.~   "
116815|NCT01527006|"~     This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel~     oral suspension on seizure frequency in pediatric participants maintained on one to three~     stable antiepileptic drugs~   "
116816|NCT01526980|"~     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control~     of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in~     subjects with type 2 diabetes.~   "
116817|NCT01526967|"~     The purpose of this study is to estimate the incidence and severity of peristomal skin~     lesions and evaluate the progression of the peristomal skin condition at 8-15 days following~     application of the barrier.~   "
116818|NCT01526954|"~     This study is designed to evaluate the safety and efficacy of the device while reducing the~     amount of drainage from surgical wounds following large flap surgical procedures, in this~     case abdominoplasty, as compared to the standard of care (closure techniques). It is~     hypothesized that the use of the Cohera device will facilitate reduction or closure of dead~     space when applied to planar surfaces created during an abdominoplasty procedure.~   "
116823|NCT01526889|"~     This is a multi-center, randomized, active-controlled, open-label study. Approximately 24~     patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring~     systemic immunosuppressive therapy will be enrolled.~      Safety, efficacy, and PK assessments will occur at scheduled visits over a 12-week period.~     Low-molecular-weight non-steroidal immunosuppressive medications are allowed up to the~     baseline day as long as the dose has not changed in the 3 weeks prior to baseline, except~     for corticosteroid doses for which may change.~      Patients responding to treatment will be offered up to 6 months of extended tretment~     Assessments for safety will include laboratory safety tests, ECGs, physical exams, ocular~     exams, vital signs and the monitoring of adverse events.~      Study participation may vary from a minimum of 3 months to a maximum of 9 months~   "
116824|NCT01526876|"~     Patients with acute brain injury are at risk for complications such as increased pressure in~     the brain (intracranial pressure, ICP), decreased blood flow, bleeding, and brain swelling~     (cerebral edema). Several studies have suggested that high blood pressure is associated with~     a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding,~     as well as increased brain swelling (cerebral edema). High systemic (body) blood pressure~     (SBP) may also increase the risk of ongoing bleeding. Therefore lowering the blood pressure~     (BP) is critical, as continued bleeding occurs most frequently in patients with high BP.~      Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment~     of acute high blood pressure (hypertension). Cleviprex is given through an intravenous line~     (IV) and has the benefit of being faster acting and easier to control adjustments than other~     drugs used to treat high BP. Patients who have an acute brain injury and who have severe~     high BP may benefit from this faster acting medication.~      For this study, eligible patients, 18 yrs of age or older, will have been admitted to the~     Neurocritical care unit within 24 hours after their brain injury, who have high systemic~     (body) SBP. The treating physicians will have already had multimodality brain monitoring~     placed for clinical management of the patient (standard care).~      The investigators will use Cleviprex to lower their SBP and record brain pressure and brain~     blood flow measurements from the multimodality monitoring. Due to the severity of their~     brain injury most of the patients eligible for the study will be unable to provide consent.~     Informed consent will be sought from a surrogate (family member, spouse or close friend)~     according to CUMC guidelines.~      Cleviprex is fast acting and effects are seen in about 90 seconds. The medication will be~     started at a low rate, and if the SBP still needs lowering, the dose increased every 90~     seconds until the maximum FDA approved dose is reached. If the SBP is still high, another~     medication used to treat high blood pressure will be added (Cardene or labetolol).~      Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. As part~     of standard care, patients have their blood pressure monitored continuously. After 6 hours~     the treating physician will make a determination to continue clinical management with~     cleviprex or another antihypertensive medication.~   "
116825|NCT01526863|"~     The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral~     tolerance induction to egg in children allergic to egg as compared to a placebo.~   "
116826|NCT01526850|"~     The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem~     cells (MSC) for the treatment of patients who have developed an extensive chronic graft~     versus host disease (with skin and/or liver damage) after HSCs transplantation and do not~     respond to first-line therapy.~      The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC)~     on one-year survival rate, long-term survival rate, life quality and recurrence of patients~     who have developed an extensive chronic graft versus host disease (with skin and/or liver~     damage) after HSCs transplantation and do not respond to hormone treatment.~   "
116827|NCT01526837|"~     This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered~     into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first~     recurrence.~   "
116828|NCT01526824|"~     In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in~     patients who are candidates for neuroendovascular stenting, it is standard of care to treat~     these patients with antiplatelet therapy, or blood-thinners, the most common of which is~     clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem~     encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study~     in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza,~     or fish oil) can increase a patient's response to therapy with clopidogrel, but there have~     been no studies in neuro patients. In this study, patients will be divided into one of two~     groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza.~     In the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done~     to measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5~     if still inpatient, and at a follow-up visit 20-30 days after the start of the study. The~     investigators believe that this study will show an increase in platelet aggregation in~     patients receiving both clopidogrel and Lovaza.~   "
116829|NCT01526811|"~     The purpose of this study is to assess the benefits of endovascular repair with Endurant~     Stent Graft System by documenting overall mortality, complications, the rate of conversion~     to open surgical repair, and the development and rupture of the aneurysm on a long term,~     i.e. at 5 years, in a cohort of patients representative of the population treated under~     real-life conditions of use in France.~   "
116830|NCT01526798|"~     Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical~     signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs).~     This study aims to demonstrate that high cut-off hemodialysis is effective in reducing~     chronic inflammation and thereby improving response to ESAs.~   "
116831|NCT01526785|"~     The objective of this study was to evaluate the efficacy and safety of treatment with 4000~     litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.~   "
116832|NCT01526772|"~     Improvements in imaging technology have allowed for the development of small endoscopes~     (slim scopes) half the size of a typical endoscope. These small endoscopes can be passed~     transnasally into the esophagus and stomach with only local anesthesia to the nasal passage~     without the need for deep sedation. They have been used in the detection of diseases of the~     esophagus and stomach,3,4 but have not been used in the detection of complications in the~     post bariatric population~   "
116833|NCT01526759|"~     Dietary fibre seems to have a relevant role in body weight management. In an acute study the~     investigators found that high viscous-high gelling pectin increased feelings of satiety. The~     objective of this study is to study the effects of 2 weeks of supplementation of high~     gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy~     intake.~      The investigators do this by measuring the difference in ad libitum energy intake after 15~     days of pectin or 15 days of control supplements. The investigators will further measure~     differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and~     composition of microbiota.~   "
116834|NCT01526746|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown products) in the blood of individuals with~     severe renal impairment compared to individuals who have normal renal function. The safety~     and tolerability of tasimelteon will also be assessed throughout this study.~   "
116836|NCT01526720|"~     Type 2 diabetes mellitus is a complex disease whose clinical phenotype results from the~     variable combination of genetic and nongenetic factors. The aim of the present study is to~     investigate the network linking phenotypes and genotypes in patients with newly diagnosed~     type 2 diabetes mellitus. In selected cases, in which clinical evidence hints at possible~     monogenic basis of the disease, the genotype and the phenotype of relatives also will be~     assessed to elucidate further the etiology of the disease.~   "
116837|NCT01526707|"~     Approximately 5−10% of people with asthma do not respond to to standard therapy and are~     referred to as having difficult asthma. Evidence shows that this poor response is not always~     related to asthma severity and non−adherence to treatment is recognized as a common~     underlying problem, in 35% of these patients. Recognising non−adherence in the clinic is~     problematic as there is no straightforward objective test to identify it.~      Previous studies have demonstrated up-regulation of FKBP51 gene expression following~     treatment with steroids, making it a potential biomarker of steroid exposure. It is~     therefore also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The~     investigators plan to assess the feasibility of distinguishing non-adherent subjects who are~     by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene~     expression in sputum and throat swabs.~      To do this the investigators will obtain throat swab and sputum samples from healthy~     volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if~     FKBP51 gene expression is comparable in each group.~      The investigators will then compare the FKBP51 gene expression response to directly observed~     inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will~     identify if the response in gene expression distinguishes steroid exposed (adherent) from~     steroid naïve (non-adherent) patients.~      Identifying non-adherence will benefit patients by enabling appropriate tailored management~     for non-adherence to enhance treatment effectiveness. It will also identify patients with~     therapy resistant asthma who have an unmet need and may benefit from expensive novel~     therapies such as Omalizumab.~   "
116838|NCT01526694|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in~     patients with multiple myeloma (MM) patients after treatment with lenalidomide and~     bortezomib or which are ineligible to one of these drugs.~   "
116839|NCT01526681|"~     This study is a registry of general use of Avance Nerve Graft and is intended to evaluate~     the uses, response rates, and safety of Avance Nerve Graft in the real life clinical~     setting.~   "
116840|NCT01526668|"~     The purpose of the study is to investigate the effect of four different follow-up strategies~     on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions.~     Furthermore the investigators aim to examine associations between preoperative thresholds~     for pain (thermal and pressure) and postoperative pain and development of chronic pelvic~     pain after benign hysterectomy.~   "
116841|NCT01526655|"~     The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy~     compared with abdominal hysterectomy in a fast track program gives a faster recovery~     postoperatively, causes less tissue damage and less effects on the immunological system, and~     is health economically cost-effective.~   "
116842|NCT01526642|"~     Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory~     failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed~     to treat acute respiratory failure but little information is available about the benefits of~     home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure~     surviving an acute hypercapnic respiratory failure. The purpose of this study is to~     determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic~     respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory~     failure (AHRF) treated by Non-invasive ventilation (NIV).~   "
116843|NCT01526629|"~     With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number~     of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the~     recent years. This has resulted in an increase of the number of follow-up (FU) to be~     performed and a growing workload for centers. Remote FU system such as the Medtronic~     Carelink system allows to check remotely the proper functioning of self evaluating devices~     and give informations of some clinical events.~      The objective of this study is to define which patients with a remote follow-up need~     additional onsite visit and to assess to which extent remote FU can be an alternative to~     onsite visit.~   "
116844|NCT01526616|"~     The investigators examined whether a combined therapy with low-dose spironolactone plus~     metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary~     Syndrome (PCOS) patients.~   "
116845|NCT01526603|"~     This is a standard of care document, outlining the therapy for children with high risk~     neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.~   "
116846|NCT01526590|"~     In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was~     estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer~     requires surgical removal. Surgical removal of the pancreas is associated with high~     morbidity and mortality, as well as high rates of complications. One way to aid surgeons in~     removing pancreatic tumors is by providing them with a good idea of where the tumor is~     located and what surrounding structures are involved. This currently happens through many~     different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound.~     Even with these forms of imaging (and sometimes others), surgeons will occasionally open a~     patient and find that the tumor cannot be removed due to its involvement with surrounding~     structures.~      One way to avoid potentially unnecessary procedures or to help a surgeon navigate this~     delicate procedure would be to provide more detailed information about the tumor. Several of~     the techniques currently used to image the body have rapidly advanced over recent years.~     Typical advancements come through better resolution of the images or contrast to enhance~     desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound~     has seen substantial advances in resolution to enhance picture quality, but contrast has not~     been used clinically to assess pancreatic masses whereas it is for cardiologists to use~     contrast to look at potential defects in the heart.~      The contrast that is used with ultrasound is different from that of CT scans. CT scanners~     use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in~     some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled~     with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the~     sound waves differently than the surrounding tissue and thus provide contrast between normal~     tissue and abnormal tissue. The contrast used in this study, Definity, and is the same~     contrast used by Cardiologists.~      The CE-EUS will be used for research purposes only and will not be used for any clinical~     decision making. The surgeon will be blinded to the results of the research CE-EUS. The~     investigators will compare the research pre-operative contrast enhanced endoscopic~     ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic~     involvement seen in surgery and the pathology reports.~   "
116847|NCT01526577|"~     This will be a dose block-randomized, double-blind, active and placebo controlled, single~     and multiple dosing, dose-escalation study to evaluate tolerability, safety and~     pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations,~     vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation~     and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic~     evaluations will be conducted at specified time points.~   "
116848|NCT01526564|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse~     drug reaction, and the primary manifestations are different degree of neuromotor,~     sensorineural and autonomic nervous dysfunction.~   "
116849|NCT01526551|"~     The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus~     (HPV) vaccination program to determine if the combination of increased disease and vaccine~     education coupled with the removal of barriers will positively impact the HPV vaccination~     uptake and completion rates among students.~   "
116850|NCT01526538|"~     This study will test the efficacy of d-cycloserine in enhancing response to learning-based~     treatment for cocaine dependence, specifically contingency management.~   "
116851|NCT01526525|"~     The aim of the present study is the comparison of the efficacy of the perioperative~     application of a multimodal analgesia model to the patients, combing common used analgesics~     via intravenous (IV) route, such as tramadol and ketamine, with or without the~     Electroacupuncture (E/A) technique application and the frequency of side effects accession.~   "
116852|NCT01526512|"~     The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide~     and capecitabine in pretreated metastatic breast cancer.~   "
116853|NCT01526499|"~     The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition~     to docetaxel in first line therapy in metastatic breast cancer.~   "
116854|NCT01526486|"~     Patients with melanoma, some other rare skin cancers, and some cancers of the penis and~     scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called~     the groin. Medically, this area is called the inguinal area. At present, for melanomas and~     skin cancers this type of spread is usually found with a special test called a sentinel~     lymph node biopsy. This procedure can find spread of even a few cells in a single lymph~     node—allowing the treating doctor to find the spread very early.~      Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of~     the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot~     have any evidence of cancer having spread either by physical examination or by radiology~     tests, the lymph nodes in this area are removed to check and see if there is cancer in them.~     This is called staging.~      At present, the standard way to remove all of the lymph nodes in the groin is by a large~     incision, approximately 8-10 inches in length. For patients who have this operation, there~     is a very high incidence of infection after surgery: as many as 50% as patients can have a~     problem after surgery. These infections range from a low grade skin infection needing oral~     antibiotics to deep infections requiring the wound to be opened and occasionally needing~     readmission to the hospital and antibiotics given via the vein.~      With the advent of new technology and new equipment, the ability to perform this procedure~     through small incisions away from the groin and further down the leg has become possible.~     This procedure has never been performed routinely nor compared side by side to the standard~     open approach. The investigators propose to perform this protocol in two phases.~      The investigators have performed procedures in 20 groins to this point and have confirmed~     the number of lymph nodes and visually verified that the procedure is identical to the open~     procedure. The investigators performed these procedures in order to insure that the~     investigators were offering an equivalent option regardless of which procedure the patient~     is randomized to.~      The study will involve the randomization of patients undergoing the procedure. The~     investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the~     videoscopic procedure for every one who gets the open procedure) until 73 patients are~     included in the video arm and 37 in the open arm. Outcomes including recurrence rate,~     duration of drain requirements, and incidence of lymphedema will be followed. Patients will~     be followed using standard of care processes, including regular office visits, physical~     exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.~   "
116855|NCT01526473|"~     HER2 is a protein that is over expressed in 20-30% of breast cancers. It is also found~     associated with lung, gastric, ovarian, and pancreatic cancers. Although there are existing~     therapies that can target HER2, most patients will eventually experience progression of~     their disease even though their cancer continues to express HER2. Therefore, new approaches~     are needed for treating tumors that express HER2.~      This clinical trial will use an investigational cancer vaccine called HER2 VRP or AVX901.~     The vaccine is based on a virus called Venezuelan equine encephalitis but it has been~     changed so it cannot cause active infection. Instead, the virus has been changed so it tells~     the immune system to attack cancer cells which make HER2.~      The objectives of the study are to evaluate the safety of immunization with HER2 VRP in~     patients with advanced or metastatic malignancies that express HER2, and to test whether~     immunization will causes a strong immune system attack against the cancer.~   "
116856|NCT01526460|"~     The purpose of this study is to evaluate the effect of a loading dose of two different~     statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which~     is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and~     clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for~     coronary disease with chronic stable angina and/or evidence of inducible myocardial~     ischemia.~   "
116857|NCT01526447|"~     The purpose of this randomized controlled trial is to determinate the efficacy and safety of~     Craniosacral Therapy in the treatment of chronic unspecific neck pain.~   "
116858|NCT01526434|"~     The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical~     function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in~     Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis~     Factor alpha (TNFα) Certolizumab Pegol (CZP).~   "
116859|NCT01526421|"~     Highly active antiretroviral therapy (HAART), the current standard of care for treatment of~     HIV infection, is highly effective when taken appropriately. Before starting this treatment,~     a person must be aware of their HIV status and present to a clinic for medical care. They~     then undergo screening procedures (medical assessment and laboratory tests) to determine~     whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe~     for them.~      In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV~     infection among users of illicit drugs. However, HIV-infected drug users often do not~     present to the medical system and complete the process necessary to start HAART. Given the~     known benefits of HAART, new strategies are required to increase rates of HAART initiation~     in this group. Contingency management (CM) is a strategy to affect behaviour by providing a~     reward (e.g. money) to reinforce the desired behaviour. CM has been used with success in~     other areas of medicine (e.g. smoking cessation, weight loss) and in the drug using~     population, but has not been established as a means to improve HAART uptake.~      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in~     engaging HIV-infected drug users in HAART programs. Drug users identified through outreach~     will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be~     offered a monetary-based reinforcer to participate (n=150) and participants in the second~     arm will be offered no reinforcer (n=150). Participation involves reporting to the study~     site for formal study of eligibility screening, consisting of clinical evaluation, medical~     history and laboratory testing required to determine eligibility to receive HAART.~     Participants randomized to the reinforcer arm will receive gift cards at the completion of~     screening procedures.~      Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly~     more likely to complete HAART eligibility screening than those not offered a reinforcer.~   "
116860|NCT01526408|"~     The specific aim of this study is to determine the efficacy of treatment with famciclovir in~     unilateral Meniere's Disease patients, specifically whether hearing can be improved. The~     investigators will determine the percentage of unilateral Meniere's Disease patients~     experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir~     as compared to the placebo arm.~   "
116861|NCT01526395|"~     In developing countries, electroconvulsive therapy (ECT) is typically delivered without the~     use of an anesthetic prior to the treatment, known as unmodified ECT. This interventional~     study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical~     University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose~     anesthetic (propofol) prior to ECT delivery. In so doing, the investigators hope to~     facilitate the transition from unmodified to modified ECT without incurring excessive costs~     to the center. It is hypothesized that ECT patients will opt for modified treatment, that~     adverse effects will be minimal, and that costs will not rise prohibitively.~   "
116862|NCT01526382|"~     PiCCO has been widely used in critical care settings for several decades. Together with~     pulmonary artery catheter, it is regarded as the important tool for guiding fluid management~     in patients with shock or acute respiratory distress syndrome. However, its effects on~     patients' outcome remain untested. The investigators study is a pilot study that is designed~     to test whether the use of PiCCO will improve patients' outcome, as compared to those~     without PiCCO monitoring.~   "
116863|NCT01526369|"~     The proposed phase III randomised trial will compare the efficacy of trastuzumab and~     paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2~     positive metastatic breast cancer. The investigators will also examine potential predictive~     biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and~     serum samples.~   "
116864|NCT01526356|"~     The study is a multi-center prospective, randomized, double-blind, placebo-controlled~     evaluation of the safety and efficacy of a topically applied formulation of rapamycin to~     cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will~     apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly~     to their angiofibromas for six months.~      The primary goal of this study is to evaluate the efficacy of the topical medication for~     reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study~     is to confirm the safety of the topical medication.~   "
116865|NCT01526343|"~     While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years,~     virtually all of the historical series reported only the recurrence of symptomatic AF and~     have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use~     of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the~     Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative~     arrhythmia burden following surgical treatment for AF in patients undergoing either lone or~     concomitant heart surgery.~   "
116866|NCT01526330|"~     The objective of this study is to assess the safety and tolerability of YH14618 during 24~     weeks of follow-up period after single administration in patients with degenerative disc~     disease.~   "
116867|NCT01526317|"~     This clinical trial is designed to compare the pharmacokinetic characteristics of~     combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin~     SR). Also investigate drug interaction between separate and combination administration.~      Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day~     administration, 10 days washout after 5th day of administration.~      All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3~     each period.~   "
116868|NCT01526304|"~     Kidney stones are very common in industrialized countries and the lifetime risk is about 10~     to 15% in this population. Kidney stones are composed of inorganic and organic components.~     Calcium containing stones are the most common stone type accounting for more than 80% of~     kidney stones. Many factors predispose or contribute to the development of kidney stones,~     including genetic variants or mutations, diet, environmental factors, and behavior. To date,~     little is known on fibroblast growth factor (FGF23) levels in patients with calcium~     nephrolithiasis. FGF23 is crucial for phosphate homeostasis including physiological and~     pathophysiological conditions such as X-linked hypophosphatemic rickets and it seems that~     FGF23 is probably the most important regulator of serum phosphate and calcitriol~     (1,25(OH)2D3) levels in addition to parathyroid hormone (PTH) produced by the parathyroid~     gland. Novel factors such as Klotho and Sclerostin, which are involved in the~     bone-kidney-parathyroid endocrine axis, have been identified recently. Klotho is a putative~     aging suppressor gene and its deficiency results in osteopenia, hyperphosphaturia, and~     calcification. Klotho is mainly expressed in the kidney but also in the parathyroid gland~     and acts as a FGF23 specific co-receptor mediating FGF23 participation in the~     bone-kidney-parathyroid endocrine axis as described above. Sclerostin is a protein secreted~     by osteocytes that inhibits bone formation by osteoblasts. However, the potential role of~     FGF23, Klotho, and Sclerostin in nephrolithiasis is still poorly under-stood or even~     unexplored. The aim of this study is to test if levels of FGF23, Klotho, and Sclerostin are~     differentially regulated in kidney stone formers.~   "
116869|NCT01526291|"~     This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related~     quality of life (QOL)in up to 550 active duty subjects prior to and six months following~     state-of-the-art laser in situ keratomileusis (LASIK).~   "
116870|NCT01526278|"~     This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy~     postmenopausal women~   "
116871|NCT01526265|"~     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking~     cessation randomized controlled trial (RCT) among CVS employees. The investigators will be~     able to determine the comparative and absolute efficacy and effectiveness of 4 different~     incentive structures that are each grounded in behavioral economic principles. Additionally,~     the investigators will measure rates of and reasons for acceptance of each incentive~     structure, and examine participant characteristics that modify the efficacy and acceptance~     of different incentive structures.~   "
116893|NCT01525979|"~     This proposed project aims to~        -  compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with~          bilateral upper limb rehabilitation based on task-related practice~        -  compare the effects of unilateral vs bilateral training based on robot-assisted devices~        -  study the predictors of treatment outcomes and clinimetric properties of the~          biomechanical measures~   "
116872|NCT01526252|"~     The SCAR study uses a software program entitled QLAB, a proprietory program, developed by~     Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle~     tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study~     is minimal. Accumulation of data relevant for a population of subjects will provide a set of~     normal values for interpretation of 2DSTE and minimize any influences from differences in~     data produced from different companies. This data may also assist other researchers~     investigate other cardiac diseases and abnormalities.~   "
116873|NCT01526239|"~     Colorectal cancer is the third most common cancer diagnosed and third leading cause of~     cancer-related deaths in the United States for both men and women. The American Cancer~     Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of~     rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this~     devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been~     dropping as a result of screening and early detection of cancer. In 2007, ACS reported that~     early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could~     be prevented each year if eligible patients received screening when necessary. However,~     despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible~     US patients are currently being screened.~      Specific Aims~      The central hypothesis of this proposal is that patient-initiated prompting of primary care~     physicians of the patient's interest in screening will increase referrals for CRC screening.~     The following three areas will be investigated during this research:~        1. To determine whether a communication tool provided to patients will initiate a~          conversation with their primary care physicians about CRC screening, especially via~          colonoscopy.~        2. To determine whether this tool will impact referral patterns for screening, especially,~          although not primarily, among poor and underserved populations.~        3. To determine whether differences exist in regard to patient-physician communication~          patterns about screening among residents and faculties in the fields of internal~          medicine and family practice clinics.~      At the close of the investigators study, the investigators wish to organize quantifiable~     data demonstrating how patient-initiated prompting of primary care physicians for CRC~     screening increases early detection and decreases potential mortality from colorectal~     cancer. This data will inform a second, larger study to pursue the questions surrounding~     patient-initiated prompting in~   "
116874|NCT01526226|"~     Preterm children are at increased risk for developing lung disease due to immature lungs.~     Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous~     positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal~     cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased~     pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short~     binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With~     HFNC oxygen/air is administered via two small, thin cannulas located just inside the~     nostrils, but the nostrils are not blocked.~      The aim of this study is to compare patient comfort in premature infants treated with nCPAP~     and HFNC. The investigators hypothesis is that HFNC increases patient comfort.~      The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion~     should be born before 34 weeks of gestation and have moderate respiratory distress, thus be~     in need of nCPAP. During the study period (48 hours) the investigators will consider how~     the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort~     assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are~     stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction.~     The child's breathing pattern will be carefully monitored. The study involves no extra~     painful investigations.~      The investigators plan to recruit 20 patients.~   "
116875|NCT01526213|"~     Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances~     shown to interact with a variety of medications. However, unanswered questions remain~     regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice~     interactions. Compounds in grapefruit juice called furanocoumarins have been established as~     major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs,~     leading to increased circulating drug concentrations. Increased drug concentrations can in~     turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown,~     paradoxically, to decrease circulating concentrations of some drugs, including the~     non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible~     metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine~     concentrations is unknown. The purpose of the proposed study is to compare the effects of a~     furanocoumarin-free grapefruit juice with grapefruit juice on circulating concentrations~     of fexofenadine.~   "
116876|NCT01526200|"~     Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver~     metastases (CLM) has become a part of clinical practice. However, if it should be~     selectively or routinely applied remains unclear. This study is carried out to clarify which~     are the criteria for a selective use of CE-IOUS if any.~   "
116877|NCT01526187|"~     The purpose of this study is to Measure the fecal carriage of multidrug-resistant bacteria~     after a travel in the tropics.~   "
116878|NCT01526174|"~     The investigators plan to conduct an open-label intratympanic injection proof-of-concept~     trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in~     patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using~     a two-arm approach. First, the investigators propose to dose 3 individual subjects with a~     single intratympanic injection of golimumab and follow each for 30 days, closely examining~     them for adverse events. If there are no serious adverse events, with FDA approval, the~     investigators propose to dose 14 subjects, each with 4 intratympanic injections of~     golimumab.~   "
116879|NCT01526161|"~     Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative~     medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment~     Guidelines recommend when this treatment is not working other treatments are started.~     Studies to support this have taken place in adults but not with children. If patients are~     instructed how to use inhalers and are given information about asthma, they can control~     their disease much better. The first part of this study, lasting 4 weeks, will make sure the~     children and their families understand how to use their inhaler. All children will be given~     the same steroid inhaler to use and after 4 weeks those still with symptoms will enter the~     study proper which lasts for 48 weeks. During this part of the study the children will be~     given one of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler~     containing a steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an~     active tablet. In this way the patient, the family and the researchers will not know which~     of the three treatments the child is taking until the code is broken at the end of the~     study.~      What matters to children is how they feel, are they able to run around and play with friends~     and are they well enough to go to school. The investigators will assess which of the above~     treatments best allow these to happen by asking the parents and children to fill in~     questionnaires on 4 occasions during the study. The investigators will also see which~     treatment best prevents the need for short courses of steroids tablets during the study.~     These are commonly given when asthma symptoms worsen.~      Most children will be started in the study through their general practitioner clinic. It~     will take one year to enroll all 900 children. Once enrolled the children will be~     followed-up in hospital centres. Much of the funding will be required to recruit and~     follow-up the children, train everyone to the same standard and develop and administer the~     questionnaires and health economic assessments. Asthma care is an expensive. The~     investigators will look at the costs and assess which treatment offers most benefit. The~     team has experience and ability in this field and will ensure the results are well~     publicised. Any child can withdraw from the study at any time.~   "
116880|NCT01526148|"~     This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness~     trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who~     currently require a medication change for their illness. Stratified randomization will~     reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The~     enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary~     outcome is the difference between lithium and quetiapine in the time to 'all cause'~     medication discontinuation.~   "
116881|NCT01526135|"~     This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with~     gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in~     patients with resected pancreatic adenocarcinoma.~   "
116882|NCT01526122|"~     The purpose of this study is to compare characteristics and safety after oral administration~     of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2~     capsules coadministration in healthy male volunteers.~   "
116883|NCT01526109|"~     Quality of Life (Qol) is a complex concept which relates to the perception of subjective~     satisfaction, especially in elderly population. It also relates to the self-perception of~     psychological status, independence level, to the social relationships, and to the~     environment where the elderly person lives. Consequently, there are a number of factors~     which may change the perception of QoL, namely the occurrence of diseases, physical~     impairment or incapacity, and the rupture of social relationship, as well as the aging~     process itself. Physical exercise is associated to improvement of mental and physical~     health. However, few studies investigated the effect of strength training and whole- body~     vibration training on elderly subjects. Following this line of reasoning, the purpose of the~     present study is to assess the effect of physical exercise on cognition and functional~     abilities in elderly subjects. Design: Randomized controlled trial, double-blinded, with~     12-week follow-up. Setting: Gama Filho University. Participants: Healthy Elderly.~     Interventions: The patients will be randomly assigned to a strength training group (STG),~     whole-body vibration training group (WBVG) and a control group (CG). Main outcome measures:~     Cognitive function will be assessed using Mini Metal State Examination (MMSE), Trail A and~     B, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional~     capacity will be evaluated using Senior Fitness Test, American Alliance for Health, Physical~     Education, Recreation & Dance(AAHPERD)functional fitness test, and Short Form 36(SF-36)~     health survey.~   "
116884|NCT01526096|"~     The purpose of this study is to test whether regulatory T-cell reduction is possible and~     safe in myeloma subjects undergoing autologous stem cell transplantation (ASCT).~   "
116885|NCT01526083|"~     The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day~     (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in~     healthy male volunteers.~   "
116886|NCT01526070|"~     Over the last several years, the standard of care for wet macular degeneration has become~     treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as~     frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor,~     Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained~     anatomic and visual improvement with many fewer injections (typically monthly injections for~     3 months, followed by every-other-month injections, and as few as 5 injections a year). The~     purpose of this study is to determine whether patients who have switched from ranibizumab to~     VEGF Trap-Eye have comparable results.~   "
116887|NCT01526057|"~     In this study, patients with moderate to severe rheumatoid arthritis who are being treated~     with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan~     (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the~     drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and~     by comparing these levels among the different treatments. Safety, tolerability and~     immunologic response also will be evaluated throughout.~   "
116888|NCT01526044|"~     The purpose of this study is to evaluate the accuracy and reliability of the continuous~     glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill~     patients by comparing subcutaneous measuring with the current standard of arterial measuring~     by a point of care glucometer.~   "
116889|NCT01526031|"~     The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture~     (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose~     effective.~   "
116890|NCT01526018|"~     The purpose of this study is to pilot test whether a novel infant feeding bottle changes how~     much formula an infant drinks and how quickly he/she drinks it, as compared to meals~     provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be~     provided with the novel feeding bottle and caregivers will be asked to acclimate their~     infant to this bottle during the next several weeks. Once acclimated, infants will undergo~     two weighed, timed, and videotaped test meals on two separate days; one with the novel~     bottle and one with their standard bottle, in random order. It is hypothesized that when the~     novel bottle is used, infants bottle will consume smaller meals and will have a longer meal~     duration, as compared to when a standard bottle is used.~   "
116891|NCT01526005|"~     Even though the health risks and societal costs of cigarette smoking are well-known, roughly~     19.8% of American adults continue to smoke. While most smokers endorse a desire to quit,~     very few (< 5%) will actually quit in a given year without treatment, and only about 20-25%~     achieve abstinence after 6 months or more of effective treatment. Therefore, there continues~     to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current~     first-line medications for Tobacco Dependence include nicotine replacement therapies (such~     as the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and~     bupropion HCl (Zyban), with the current standard of care in most treatment settings being to~     choose specific medications based primarily on availability, ease of use, and patient~     preference. The goal of the proposed research is to improve the delivery of smoking~     cessation treatment by determining if pre-treatment nicotine receptor density in cigarette~     smokers is associated with smoking cessation outcome with the standard nicotine patch taper.~     The study's main hypothesis is that cigarette smokers with less pre-treatment upregulation~     of nicotine receptors will have a greater likelihood of quitting smoking from a standard~     course of nicotine patch treatment than smokers with more up-regulation of these receptors.~     Positron emission tomography (PET) will be used to test this hypothesis.~   "
116894|NCT01525966|"~     This phase II trial studies how well giving carboplatin and paclitaxel albumin-stabilized~     nanoparticle formulation together before surgery works in treating patients with locally~     advanced or inflammatory triple negative breast cancer. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~   "
116895|NCT01525953|"~     The aim of this study is to identify prognostic factors for outcome in patients being~     complete clinical responders with chemoradiation or radiation for esophageal cancer~   "
116896|NCT01525940|"~     Colorectal cancer (CRC) is the second most common cause of cancer-related death in the~     Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary~     CRC screening tool in many countries. As a preventative procedure, its main purpose is to~     enable the early diagnosis of CRC at a curable stage and to identify and remove~     pre-malignant adenomas. Cecal intubation is associated with an increased detection rate of~     advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon.~     Complete colonic evaluation is therefore a well-recognized measure of colonoscopy quality~     control. Cecal intubation rates of ≥ 90% of all colonoscopies in routine clinical practice~     and ≥ 95% in screening colonoscopies are recommended. Unfortunately, the cecal intubation~     rate in daily clinical practice is often lower than the target of ≥ 90%, with reported~     percentages varying from 76.9% to 98.4%. This means that after an incomplete colonoscopy,~     malignant and pre-malignant lesions may be missed if further investigation is not pursued.~     Several explanatory factors for incomplete colonoscopy have been described. After an~     incomplete conventional colonoscopy, patients are required to undergo another test to~     complete the visualization of the colon. Options for incomplete examinations because of~     anatomic reasons include both radiologic and endoscopic means.~      CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not~     require sedation and is well accepted by the patient.~      The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an alternative approach~     for endoscopic visualization of the colon in patients with an incomplete conventional~     colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the~     elimination of the need for sedation, the minimally invasive, painless nature of the exam,~     no need of X-rays and the ability to pursue normal daily activities immediately following~     the procedure. This is a study that is designed to evaluate the performance of the PCCE in~     the evaluation of patients with an incomplete colonoscopy, compared to the CT-colonography.~     PCCE and CT-colonography procedures will be compared in regards to completeness of the~     procedure and detection of lesions in the colon that would have been missed by the~     incomplete conventional colonoscopy.~   "
116897|NCT01525927|"~     This study looks at the use of three cycles of chemotherapy given prior to radiation therapy~     in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma~     Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV~     have a better prognosis than those who do not have such evidence of exposure to HPV. The~     main hypothesis of this study is that using three cycles of chemotherapy prior to embarking~     on radiation therapy will allow the use of reduced doses of radiation therapy and,~     therefore, less radiation induced side-effects. The primary objective is to determine the~     activity of this pre-radiation chemotherapy strategy along with reduced dose levels of~     radiation with or without chemotherapy during the radiation phase. The effectiveness of the~     strategy will be assessed at three months following the completion of the radiation therapy~     phase and also at two years following completion of the radiation therapy.~   "
116898|NCT01525914|"~     Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with~     dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men~     who harbor occult high grade prostate cancer.~      The study will determine the prevalence of a secondary rise in PSA > 0.5 ng/ml and the PSA~     doubling time in subjects on surveillance being treated with dutasteride.~   "
116899|NCT01525901|"~     The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1)~     treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene~     deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection~     under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name~     Increlex for the treatment of children with short stature due to primary IGF-1 deficiency.~     It is being used off-label in the current study and is not FDA approved, nor has it yet been~     studied in humans for the treatment of SHANK3 deficiency.~   "
116900|NCT01525888|"~     The aim of the current study is to evaluate prospectively whether concomitant administration~     of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence~     the change in estimated glomerular filtration rate or GFR (eGFR) after administration of~     contrast media in patients undergoing non-emergent coronary angiography.~   "
116901|NCT01525875|"~     The purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on~     the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in~     subjects with pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that~     has been shown in some research to reduce these calcium deposits. This study consists of two~     parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an~     open-label, year-long study. In Part 1, qualified subjects will be randomized to receive~     either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The~     starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased.~     Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy;~     eye examination; bone density test; and photography of skin lesions. Subjects will be~     evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon~     completion of the first year, barring any safety concerns, all subjects will be administered~     magnesium oxide supplements for up to one additional year. Subjects will undergo the same~     evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a~     reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.~   "
116902|NCT01525862|"~     This is a study looking at transnasal sinus balloon dilation without tissue removal treating~     the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic~     improvement post-procedure.~   "
116903|NCT01525849|"~     The objective of this study is to show that long-term symptom improvement following sinus~     balloon dilation is not worse than symptom improvement following functional endoscopic sinus~     surgery.~   "
116904|NCT01525836|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Rituximab for the treatment of adults with refractory immune~     thrombocytopenia (ITP), compared to conventional Rituximab therapy.~   "
116905|NCT01525823|"~     The purpose of this study is to assess the effects of Metformin administered over two weeks~     on the peak plasma glucose concentrations following administration of BMS-754807.~   "
116908|NCT01525784|"~     The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age~     groups, especially among infants and toddlers.However, only 30% of diabetic children manage~     to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are~     treated by intensive insulin therapy.Recently, devices for real-time continuous glucose~     monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These~     devices enable the patients to see the interstitial glucose levels continuously, the trends~     of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .~      The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years~     in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the~     investigators study is to examine prospectively the short and long term effect of the~     RT-CGMS routine usage, in daily routine life of the diabetic child.~   "
116909|NCT01525771|"~     A maximum of 8 cycles of chemotherapy will be administered. Depending on patients'~     tolerability, 8 cycles of chemotherapy will be given to the patients.~   "
116910|NCT01525758|"~     The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with~     knee osteoarthritis by orally administration and to determine optimal dose.~   "
116911|NCT01525745|"~     The purpose of this study is to determine how effective SBRT is compared to traditional~     radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is~     delivered at a higher dose for a shorter period of time when compared to standard radiation~     therapy and the aim is to see if there will be an improvement both in pain control and your~     cancer It is not known whether SBRT is better or worse than current standard therapy. If you~     are selected to receive the experimental treatment in this research study, SBRT uses highly~     focused x-rays that deliver a single high dose to a specific area of the spine compared to~     conventional standard radiation over a period of 10 days which has been the standard proven~     treatment to help your condition. The investigators will also determine which treatment~     provides the most rapid pain relief with the least side effects. It is possible that SBRT~     may not be better or could be more toxic. The investigators will conduct quality of life~     assessments and pain scale index to assess how you are feeling once you have had the~     intervention.~   "
116912|NCT01525732|"~     Spastic esophageal motility disorders induced significant symptoms including dysphagia,~     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel~     approach to perform myotomy through the esophagus with long submucosal tunnel. This study~     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques~     from animal study to clinical practice in human.~   "
116913|NCT01525719|"~     The purpose of this study is to determine whether everolimus is effective in the treatment~     of patients with advance cholangiocarcinoma.~   "
116914|NCT01525706|"~     Pancreatic cysts are becoming diagnosed more frequently due to the increased use and~     sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested~     treatment is surgery for removal. However, surgery involves significant risks and emerging~     opinion suggests that not all cysts need to be surgically removed. An alternative therapy~     would be ideal, in particular for those where surgical risk outweighs the benefits of~     resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative~     to surgical resection.~      Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for~     treatment in those with per-cancerous, mucinous pancreatic cysts.~   "
116915|NCT01525693|"~     This is a study to gain better understanding on how those patients who are newly diagnosed~     with type 2 diabetes are treated and monitored. The study will record information such as~     type of therapy, therapeutic outcomes, and patients' satisfaction.~   "
116916|NCT01525680|"~     This study seeks to examine the efficacy of hydrocortisone administration in the~     augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically~     tested treatment shown to be effective in the the treatment of posttraumatic stress disorder~     (PTSD). The augmentation builds on both the translation of neuroscience findings~     demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical~     findings from other investigators demonstrating beneficial effects of GCs in reducing~     traumatic memories in trauma-exposed persons.~   "
116917|NCT01525667|"~     Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration~     of injured gluteal musculature after Total Hip Arthroplasty (THA).~   "
116918|NCT01525654|"~     The goal of PARASS is to develop a network of increased social support for Rheumatoid~     Arthritis (RA) patients that will improve patient outcomes and further promote understanding~     of RA among physicians and patients in the clinic community. This will be accomplished with~     the development and implementation of Buddy pairing and one -on- one informational support~     to be called Patient-to-Patient Connection.~   "
116919|NCT01525641|"~     Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily~     use of Mirapex®-LA Tablets in patients with Parkinson's disease.~   "
116920|NCT01525628|"~     To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their~     combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment~     naive or prior treatment relapse patients with chronic hepatitis C infection.~   "
116921|NCT01525615|"~     The primary objective of this study is to compare the effects of orally inhaled tiotropium +~     olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance~     after 12 weeks of treatment in patients with COPD.~   "
116922|NCT01525602|"~     The goal of this clinical study is to learn how PLX3397 and paclitaxel work together to~     affect the growth of cancer cells in advanced solid tumors.~   "
116923|NCT01525589|"~     A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of~     PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts~     response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety~     profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD~     (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx)~     expression profile in tumor samples.~   "
116924|NCT01525576|"~     In this trial, we test if adding an Internet-based booster program to regular Internet-based~     cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive~     disorder (OCD).~   "
116925|NCT01525563|"~     In India Duphaston is approved and widely used for the treatment of progesterone~     deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea,~     irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and~     habitual abortion, infertility due to luteal insufficiency, as well as part of hormone~     replacement therapy. One Indian study reported normalization of the cycle in 91.6% of women~     with menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from~     11th to the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone~     therapy in this study was noted to be 28.8 days, in contrast to 17.9 days (in the~     polymenorrhea group) and 50.6 days (in the oligomenorrhea group) before therapy.~     Furthermore, dydrogesterone also decreased the amount and duration of menstrual bleeding in~     this study.~      However, there are limited data regarding Duphaston's role in achieving cycle regularization~     from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston~     therapy persists after cessation of treatment and whether the persistent effect, if any, is~     related to the duration of Duphaston therapy.~      Hence, in this observational study, given that (based on previous clinical studies as~     mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is~     to tease out the possible implications of such treatment in terms of treatment length and~     response pattern.~   "
116926|NCT01525550|"~     The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects~     with unresectable pancreatic neuroendocrine tumors.~   "
116927|NCT01525537|"~     The aim of the present study was to compare SPI guided analgesia with standard clinical~     practise during general anesthesia using a balanced setting of sevoflurane and sufentanil~     anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular~     stability, less use of analgetics and shorter recovery from anesthesia.~   "
116928|NCT01525524|"~     Stroke is one of the main public health problems in America Latina. It can be associated~     with several neuropsychiatric complications, which include a broad spectrum of emotional~     distress and cognitive, results in important clinical implications for the prognosis of~     these patients. Depression is a common complication, affecting around 5-72% of patients and~     is associated with various cognitive deficits and also with increased mortality - up to 50%~     more deaths compared to non-depressed patients. Treatment of depression after stroke is~     important not only to improve depressive symptoms but can also be beneficial for cognitive~     deficits, activities of daily living. and leads to increased survival for these patients.~     There are different treatments for depression after stroke, all showing inconclusive~     results, even though antidepressants have been effective in some groups of patients,~     tolerability and treatment adherence were not very good-so it is necessary that new~     therapeutic modalities are presented with good tolerability. In this sense, transcranial~     direct current stimulation (tDCS) is an interesting technique that can provide interesting~     results, which proved to be effective for depression in some studies. This study proposes to~     investigate the effect of tDCS for the treatment of major depressive disorder after stroke.~     The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study~     in a subsample of participants in the prospective cohort of stroke: Study of Morbidity and~     Mortality of stroke. They will be allocated to one of the groups: sham or active tDCS group.~     Participants will receive ten consecutive days of active or sham stimulation and return at~     the end of two weeks to evaluate the improvement in depression, cognition and functionality.~     As objectives, the investigators expect to see a clinical improvement of depression through~     scales like Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect~     improvement on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental~     scale exam), FAB (frontal assessment battery) and trail test. Another goal is to see~     improvement in markers related to depression as BDNF, cortisol, interleukins and heart rate~     variability. With all this, the investigators hope to offer a new treatment, and effective~     with few side effects to treat depression after stroke.~   "
116929|NCT01525511|"~     The observed changes of P. falciparum sensitivity to artemisinin leads to the~     intensification of early detection as well as treatment monitoring in malaria infection. It~     is widely accepted that the development of resistance can be delayed by the use of~     combination therapy, especially artemisinin-based combination therapies (ACTs). The~     resistance problem is considered extremely serious and as the consequence WHO has~     recommended that all monotherapy for malaria should be stopped Current WHO guideline~     recommends the drug combination regimens using ACT with effective partner medicines to~     decrease the risk of development or spreading of artemisinin resistance.~      Dihydroartemisinin-piperaquine (DHA-PQP); the fixed-dose combination of Dihydroartemisinin~     (DHA) and Piperaquine phosphate (PQP) is now one of the recommended drugs by WHO as the oral~     treatment for uncomplicated P. falciparum. DHA-PQP composes of both blood schizonticidal~     drugs, with different mechanism of action and different half-life to improve the therapeutic~     efficacy and to prevent the development of drug resistance to the individual drug. Moreover,~     it is beneficial for the mutual protection against resistance and long lasting protection~     against new infection, due to long half-life of PQP.~      Primaquine is an effective gametocytocidal for P. falciparum transmission prevention and as~     tissue killing for the radical cure in Plasmodium vivax and Plasmodium ovale infection. It~     will be given only in the presence of other antimalarials, so it is necessary that the data~     of the potential drugs interaction of primaquine and DHA-PQP should be characterized. It is~     inevitable that in the near future, Dihydroartemisinin-piperaquine (DHA-PQP) and primaquine~     combination treatment becomes necessary. These drugs are metabolized by cytochrome P450~     enzyme which potentially causes pharmacokinetic alteration, resulting in clinically~     significant drug-drug interactions that can cause unanticipated adverse reactions or~     therapeutic failures because of the suboptimal exposure of the parasite.~      This study is planned to evaluate potential pharmacokinetic interaction of orally~     administered primaquine (PQ) and dihydroartemisinin-piperaquine (DHA-PQP) in healthy adult~     subjects. The results of these interaction studies are important in order to provide~     clinical guidance for the optimum combination of primaquine and DHA-PQP treatment regimens~     in malaria infections.~   "
116930|NCT01525498|"~     The objective of this study is to prospectively evaluate the effects of early versus delayed~     removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim~     is to determine the optimal time of removal of an indwelling transurethral catheter~     postoperatively in an effort to reduce the risk of postoperative urinary retention and~     urinary tract infection associated with catheter use. The investigators hypotheses are as~     follows:~      Hypothesis 1: Longer duration of postoperative catheter use will result in decreased~     postoperative urinary retention.~      Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence~     of urinary tract infection.~   "
116931|NCT01525485|"~     This prospective study compares quality of life measures of patients with refractory~     overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation~     (Group A) and sacral nerve stimulation (Group B).~      The specific aims are:~      1. To characterize patient symptom bother score, quality of life, and body image scores in~     patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.~      - Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of~     life, patient symptoms, and body image questionnaires.~   "
116952|NCT01525199|"~     The purpose of this trial is to compare the evolution of patients receiving first line~     treatment for locally advanced or metastatic lung cancer, taking into account if they were~     requested or not the EGFR mutation test as part of the diagnosis and treatment strategy.~     There is no assignment to any particular therapeutic strategy.~   "
117035|NCT01524094|"~     The purpose of this study is to see if there is a difference in survival between two~     different treatment strategies for colorectal peritoneal surface disease. The control arm~     administered the currently considered standard treatment which is palliative systemic~     chemotherapy. The experimental arm received the combination treatment cytoreductive surgery~     and intraperitoneal chemotherapy. The investigators hypothesis is that the combination~     treatment will improve the overall survival.~   "
116932|NCT01525472|"~     Numerous epidemiological studies clearly showed the relationship between the excessive~     growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes~     and other cardiovascular risk factors. However, the mechanisms contributing to the~     deleterious role of visceral adipose tissue remain to be elucidated. Several observations~     suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities~     according to their locations. We have recently shown that visceral fat depots display higher~     immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the~     endothelial cells of visceral compared to subcutaneous adipose tissues express a~     pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that~     visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent~     higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1)~     might be a phenomenon related to the location and therefore the microenvironment of adipose~     tissue and 2) might be responsible for an abnormal activation of proinflammatory response,~     favouring the development of metabolic and secretory dysfunction of adipose tissue in~     obesity. Our working hypothesis, based on these observations, is that the visceral adipose~     tissue provides a microenvironment that promotes accelerated aging. This senescence may be~     responsible for the establishment of an inflammatory reaction, alteration of the metabolic~     activity and adipocyte differentiation capacity of progenitor cells leading to the~     development of obesity associated diseases.~      The proposed project is a descriptive cross-sectional pathophysiological study .The aims are~     1) to better define the process of senescence in human adipose tissue, 2) to precise the~     mechanisms and 3) to analyse the cellular and functional consequences of aging on~     inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for~     bariatric surgery will be studied. The collection of clinical and laboratory data and the~     collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose~     tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis~     Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in~     vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells,~     progenitor cells and immuno-inflammatory cells).~      This project will permit to better understand the pathogenicity associated with the~     excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit~     obesity-associated pathologies.~   "
116933|NCT01525459|"~     Study on glioma patients treated with brain surgery is focusing on the analysis of their~     transcriptome expression profile measured in two immune cell populations, CD4+ T cells and~     CD56+ NK cells. The results of analysis will be compared to the reference data of healthy~     population. Furthermore, the metabolomic and immunological status will also be monitored and~     compared to healthy group reference data, before and after the surgery*. With comparative~     crossomics analysis the investigators intend to possibly identify new diagnostic and~     prognostic biological markers for the relapse of the disease. The results are expected to~     convey a deeper insight into pathophysiology of the glioma as well as into the mechanisms of~     the current surgical therapy.~      * The healthy reference data have been published in collaborative efforts of BTC, UMC and~     NIB (Gruden et al. 2012).~   "
116934|NCT01525446|"~     Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints~     high doses of radiation directly to cancer. Standard radiation (or photon radiation) is~     commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is~     a special type of radiation only available at a few institutions in the US and has not been~     previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy~     of the treatment and may help to minimize the dose delivered unnecessarily to healthy~     tissue.~      In this study, the investigators are evaluating the safety and effectiveness of proton-based~     SBRT for early-stage NSCLC located in the periphery of the lung.~   "
116935|NCT01525433|"~     In this study, 400 Hispanic women will be recruited and randomized to one of three~     interventions:~        1. Control (no change);~        2. A low-intensity information program, consisting of a video approach educating women on~          the importance of cervical cancer screening;~        3. A higher intensity program consisting of the video plus a 'promotora' or lay-community~          health educator led intervention at the participant's home to encourage cervical cancer~          screening.~      The investigators will compare which intervention is most effective in encouraging Hispanic~     women to undergo cervical cancer screening (Pap test)~   "
116936|NCT01525420|"~     The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation~     outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).~      Implementation outcomes:~        -  end of treatment and 6-month follow-up data retention rates;~        -  intervention implementation quality;~        -  number & length of calls completed.~      Comparison of each arm's implementation~   "
116937|NCT01525407|"~     This phase II trial studies donor atorvastatin treatment for the prevention of severe acute~     graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem~     cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a~     donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the~     patient's immune system reject the donor's stem cells. When the healthy stem cells from a~     donor are infused into the patient they may help the patient's bone marrow make stem cells,~     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a~     donor can make an immune response against the body's normal cells. Giving atorvastatin to~     the donor before transplant may prevent this from happening.~   "
116938|NCT01525394|"~     This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled,~     three-treatment, three-way crossover study in healthy subjects. There are two phases in this~     study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of~     Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment~     Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3.~     Completion of study termination procedures will be performed at Visit 11.~   "
116939|NCT01525381|"~     Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by~     a physician within the previous five years. It will be determined what diagnostic tests were~     initially performed to make this diagnosis. Participants will undergo lung function testing~     over 6-8 weeks to determine their respiratory status and to confirm they have asthma.~     Participants may be followed up to one year depending on their test results.~   "
116967|NCT01524991|"~     Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab~     has shown intriguing activity as neoadjuvant therapy in patients with clinically localized~     bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin,~     plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more~     durable responses and improved outcomes.~   "
116968|NCT01524978|"~     This open-label, multi-center study will assess the efficacy and safety of Zelboraf~     (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tumors and~     multiple myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is~     deemed the best treatment option in the opinion of the investigator. Patients will receive~     twice daily oral doses of 960 mg Zelboraf until disease progression, unacceptable toxicity,~     or withdrawal of consent.~      The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients~     with colorectal cancer will also be assessed.~   "
116940|NCT01525368|"~     Cognitive training has been shown to be successful in patients with amnestic mild cognitive~     impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a~     randomized controlled trial, the investigators recently found that aMCI patients receiving a~     cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an~     active control group showed pronounced hypometabolism on follow-up scans in regions~     typically affected in AD.~      Previous studies indicate that not all patients respond equally well to a cognitive~     intervention. Identifying factors that predict response to treatment could help selecting~     patients for a targeted intervention. A potentially important predictor is cognitive reserve~     defined as premorbid cognitive performance. The hypothesis is that different levels of~     cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different~     neurostructural and neurofunctional correlates and influence treatment response in a~     different way. Moreover, the impact of white matter lesions on treatment effects will be~     investigated.~      The investigator will perform a complex cognitive training program. Forty patients with aMCI~     (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this~     study. Since the patients are recruited consecutively, an estimated overall number of 80~     will be included and receive the training of whom about 40 will meet the inclusion criteria~     for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group~     will be used to analyze the potential impact of white matter lesions on response to the~     intervention. Cognitive effects of the intervention will be evaluated by neuropsychological~     testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be~     measured using resting state fMRI and diffusion tensor imaging (DTI).~      For comparison, a group of 30 aMCI patients will be recruited as an active control group~     receiving study investigations (neuropsychological testing as well as MRIs), and exercises~     for self-study at home, not the complex cognitive intervention.~   "
116941|NCT01525355|"~     Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram~     will identify and risk stratify patients for the presence of CBD stones and strictures.~   "
116942|NCT01525329|"~     This randomized, intra-patient comparative study is designed to investigate the combination~     regimen of 5-FU and PDT, versus PDT alone, for its ability to generate significantly~     elevated levels of the target photosensitizer, PpIX, in lesions of actinic keratoses (AKs)~     and to more effectively treat and prevent recurrence of AKs. The target population comprises~     patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent)~     subjects to control for possible influences of immunosuppression.~   "
116943|NCT01525316|"~     The investigators propose a clinical trial in premature infants to determine the effect of~     orally-administered bovine lactoferrin on occurrence of severe infections and to determine~     whether as a result of decreased infections, infants' growth and development improve after~     daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory~     properties. If successful, the use of lactoferrin as a protective protein could profoundly~     affect clinical care of neonates both in the developed and developing world.~   "
116944|NCT01525303|"~     This proposed study seeks to examine whether adding an aerobic exercise prescription to a~     behavioral treatment program for chronic headaches will improve headache frequency and~     intensity, headache-related disability, and mood. It is hypothesized that participants who~     receive the exercise prescription at the start of treatment will show greater gains than~     those who receive the prescription halfway through treatment. It is also predicted that~     participants who begin the exercise component halfway through treatment will demonstrate~     greater improvement in the second half of treatment compared to the first half.~   "
116945|NCT01525290|"~     WAKE-UP is an investigator initiated European multicenter randomized controlled clinical~     trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset,~     e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove~     efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking~     up with stroke symptoms or patients with otherwise unknown symptom onset.~   "
116946|NCT01525277|"~     Whether the side of implantable CVCs was associated with the complication rates remains~     unclear. The investigators plan this study to explore this issue by randomizing patients to~     receive CVC implantation at the left subclavian or righ subclavian vein.~   "
116947|NCT01525264|"~     Breast cancer is the most commonly occurring cancer and most common cause of cancer~     mortality among Korean American (KA) women, but mammography utilization among KA women~     remains suboptimal. Most breast cancer screening studies with KA women have been descriptive~     and correlational. Therefore, in this 4-year project, the effects of Korean Immigrants &~     Mammography—Culture-Specific Health Intervention (KIM-CHI) on adherence to recommended~     breast cancer screening protocols were tested. The specific aims are to: (1) compare the~     group receiving KIM-CHI with an attention control group on mammogram attainment outcomes~     including number of mammograms obtained (0, 1, or 2) and if obtained, length of time to~     obtain the first mammogram, at 15 months using survival analysis; (2) compare the two groups~     on the mediating variables of health beliefs, knowledge, self-efficacy, and spousal support~     at 2 weeks, 6 months, and 15 months using repeated measures multivariate analysis of~     variance; and (3) identify the mediating effects of health beliefs, knowledge,~     self-efficacy, and spousal support at 2 weeks on mammogram attainment outcomes at 15 months,~     using structural equation modeling. Data on mammography attainment and the mediating~     variables were collected at baseline and at 2-weeks, and 6- and 15-months post-baseline.~   "
116948|NCT01525251|"~     Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year~     in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to~     the survival rate in Western countries, the treatment in Taiwan needs more efforts to~     improve. According to the report from the Childhood Cancer Foundation ROC, several children~     with neuroblastoma did not complete their treatment and or not received the protocol. In~     addition to the efforts in improving protocol, the reasons for those who drop-out and do not~     receive complete treatment need the investigators more attention to think of.~      Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on~     caregivers' adaptation of disease uncertainty about then child with neuroblastorna.~      Methods: A longitudinal and prospective design will be used to perform this study.~     Questionnaire survey and chart review will be the means of data collection for the part of~     quantative analysis. The qualitative method , semi-structural interview , also will be used~     to collect data regarding caregiver's perception of social support and adaptation at the~     same time of self-report of questionnaires survey .There are five points of time to collect~     data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after~     eligible subjects agree to participate in the study.~      Subjects: The study will use a convenience sample. Once the caregiver's child is on has been~     diagnosed with neuroblastoma will be recruited in this study.~      Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the~     self-reported socio-demographic questionnaire will be used to collect data. Process~     recording will be typed once finishing interview for further analysis.~      Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The~     data will be analyzed using descriptive statistics and inferred statistics. Content analysis~     and theme formation will be categorized to assist the interpretation of quantitative~     results.~      Implication: The findings of this study will be expected of the effects of nurse care~     manager model on children with newoblastoma cancer survivors.~   "
116949|NCT01525238|"~     The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin~     in pediatric subjects with type 2 diabetes mellitus (T2DM)~   "
116950|NCT01525225|"~     The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy~     Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)~     following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet~     and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets~   "
116953|NCT01525186|"~     Background:~      A topic of interest in the etiology of child obesity is if and how parental feeding~     behaviors are associated with child food intake and weight status.~      Objectives:~      The objective was to explore if and how directive (overt) and non-directive (covert and food~     environmental structure) types of parental feeding control were associated with children's~     food intake and weight status.~      Design:~      This was a cross-sectional, exploratory study using structural equation modeling to~     determine directional associations between maternal feeding practices and their child's food~     intakes and weight status. Researchers collected data from 330 dyads of 3-5yr children and~     mothers participating in a federal preschool program for low-income families (Head Start) in~     Michigan. Mothers' feeding practices (directive and non-directive control), children's food~     intakes, height and weight of both mothers and children were measured. Structural equation~     models tested the relationships between maternal feeding practices, the child's food intake~     and weight status.~      Hypotheses:~        1. Child weight is negatively associated with parents' directive feeding control~          practices.~        2. Less directive control or greater non-directive control is associated with healthier~          food intakes in children.~   "
116954|NCT01525173|"~     This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic~     solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and~     brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients~     previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require~     additional intraocular pressure (IOP) lowering medication.~   "
116955|NCT01525160|"~     Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of~     females.~      OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping~     breathing at night). As well as affecting tiredness, mood, concentration and quality of life~     - there is growing concern that it can increase the risk of high blood pressure, heart~     problems, strokes and thromboses (clots in the veins).~      It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily~     it also causes damage to the lining of the blood vessels (endothelial injury). These effects~     seem independent of other risk factors such as obesity, smoking, family history of clots~     etc.~      The investigators are testing new biomarkers: gel point and fractal dimension developed at~     the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a~     similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies~     (Controls) Also markers of vascular inflammation are being measured.~   "
116956|NCT01525147|"~     A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I~     clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in~     healthy male volunteers~   "
116957|NCT01525134|"~     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational~     performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM)~     test in detecting tuberculosis in HIV-infected adults.~      A secondary study objective is to determine the accuracy, efficiency, costs, and~     cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including~     the novel Xpert MTB/Rif test.~   "
116958|NCT01525121|"~     This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage~     compression technique improves respiratory mechanics and is effective in secretion removal~     in mechanically ventilated patients.~   "
116959|NCT01525108|"~     In this study the investigators aim to evaluate the effect of home-based blood pressure~     measurement with an electronic device on medication adherence and blood pressure control.~   "
116960|NCT01525095|"~     The purpose of this study is to assure the uniform collection, handling, storage and~     transport of patient whole blood specimens and associated information to support validation~     of the T2 Candida Assay.~   "
116961|NCT01525082|"~     The purpose of this research is to evaluate the effectiveness and safety of a combination of~     capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic~     neuroendocrine tumors.~   "
116962|NCT01525069|"~     This pilot clinical trial studies the safety and effectiveness of continuous hepatic~     arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other~     chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that~     cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more~     directly to liver tumors and reduces side effects. HAI alone or in combination with~     oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with~     locally advanced cholangiocarcinoma.~   "
116963|NCT01525056|"~     The purpose of this study is to evaluate the accuracy of Positron emission tomography,~     Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal~     cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging~     studies will be compared to standard imaging studies and the histopathology of the surgical~     specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases~     pretreatment better than standard pretreatment scans and will better determine the degree of~     response of the primary rectal tumor to preoperative chemoradiation.~   "
116964|NCT01525043|"~     The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for~     patients with lateral and medial epicondylitis and compare it to Naproxen sodius.~   "
116965|NCT01525017|"~     The primary objective of this study is to answer the question Is it possible to inject the~     Combig-DC vaccine in a renal tumour without getting unacceptable side effects? Patients~     newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two~     occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will~     be eliminated. Adverse events will be registered, as well as changes in vital signs(heart~     rate, blood pressure and body temperature) and lab parameters. Immunologic response will be~     evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the~     size of the metastases three months after nephrectomy.~   "
116966|NCT01525004|"~     This is a phase I trial in which the both the safety and immunogenicity of the standard dose~     flu vaccine will be compared with high dose flu vaccine in children that have undergone~     solid organ transplantation (SOT).~   "
117087|NCT01523418|"~     The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis~     of VTE in Indian patients undergoing elective TKR/THR~   "
116969|NCT01524965|"~     Open reduction and locking plate osteosynthesis is a commonly used and well-accepted~     treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff~     despite intensive rehabilitation, limiting the function of the upper extremity and~     decreasing the quality of life. The accepted postoperative mobilisation protocol includes~     passive exercises until six weeks postoperatively and active range of motion exercises after~     that. There is good evidence that conservatively treated fractures of the same site heal~     better and faster if mobilised immediately. The study compares standard mobilisation~     versus immmediate mobilisation in a prospective, randomized, controlled trial in order to~     find the optimal time-frame for physiotherapy to produce best possible results. Outcome~     measures are assessed at specific time points after the operation and comparisons between~     groups are made to follow the rate of recovery and end results.~   "
116970|NCT01524952|"~     Objective:~      It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory~     fitness and reduce body fat in obese subjects. The purpose of this study is to investigate~     the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak~     oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical~     effects and the resultant lipolysis-related gene expression changes in adipocytes.~      Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per~     week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled~     with an accelerometer and nutritional questionnaire. Before and after the stimulation~     period, functional capacity are assessed by VO2 peak, and body composition was assessed by~     dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity~     will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary~     day, and adipose tissue biopsies will be taken for the gene expression analysis.~   "
116971|NCT01524939|"~     The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin~     Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.~   "
116972|NCT01524926|"~     The study will primarily assess the antitumor activity of crizotinib in a variety of tumors~     with alterations in ALK and/or MET pathways. The targeted patient population will include~     patients with tumors harboring specific alterations leading to ALK and/or MET activation,~     where tyrosine kinase inhibitors against these targets have not yet been adequately~     explored.~   "
116973|NCT01524913|"~     The purpose of this study is to determine whether the administration of hyaluronic acid or~     corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain~     relief and improved function.~      The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the~     mean visual analogue scale (VAS) at one month when compared to celestone and placebo.~   "
116974|NCT01524900|"~     This Post Marketing Surveillance study will be performed as an open-label, prospective,~     non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected~     patients. Data will only be documented in patients for whom a pharmacotherapy with~     nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients~     and pre-treated patients switching from nevirapine immediate release or other~     anti-retroviral therapy (ART) will be included in the study. The decision to initiate~     treatment with nevirapine extended release is independent of this study and is based~     entirely on individual patient need and the judgement of the treating physician. The aim of~     the study is to assess the safety and efficacy and treatment adherence of nevirapine~     extended release in HIV-1 infected patients in routine clinical practice. It is planned to~     document five visits for each patient over a twenty four week observational period.~   "
116975|NCT01524887|"~     The purpose of this study is to provide evidence of efficacy and safety to support the~     development of IGIV, 10% as a treatment option for patients with mild to moderate~     Alzheimer´s Disease.~   "
116976|NCT01524874|"~     The importance of vitamin D (VitD) in the prevention and treatment of human health~     conditions has gained increased attention in recent years. As a result, medical providers of~     all categories are screening clinical VitD status frequently, yet become challenged with how~     to best advise patients regarding repletion of VitD status, i.e. which form of VitD~     replacement is most effective. It has been recognized that to achieve significant effects -~     serum concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend~     substantially higher doses than were previously thought sufficient. These higher doses can~     be easily achieved orally. This clinical trial aims to compare absorption of three available~     forms of this fat-soluble vitamin, due to the potential differences in absorption of~     different preparations. High-quality powdered, chewable and lipid-emulsified VitD are~     readily available as supplements, yet these have not been systematically compared. This~     three-arm, randomized clinical trial will compare the difference in serum~     25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and~     after random administration of one of the three VitD preparations for 12-weeks at a dosage~     of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will~     result in an equivalent increase in serum 25OHD.~   "
116993|NCT01524653|"~     Patients with cancer have a high risk of developing venous blood clots or thromboembolism~     (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis~     (protective treatment for blood clots), numerous studies have identified serum biomarkers~     for risk of future VTE. There is also increasing evidence pointing to a prophylactic effect~     of statin therapy on the risk of developing VTE in high-risk populations including patients~     with advanced cancer. The purpose of this research study is to find out whether treatment~     with rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving~     chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on~     serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and~     tolerance of rosuvastatin therapy in this population.~      This is a phase II randomized crossover study with two 3-4 week treatment periods during~     which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a~     matching placebo tablet. Approximately two tablespoons of blood will be collected for~     biomarker analysis at the beginning and end of each treatment period. After the first~     treatment period there will be a 3-5 week break where subjects will undergo a washout.~     Following this washout period every subject will crossover or begin taking the alternative~     therapy so everyone enrolled will receive the study drug either during the first or the~     second treatment period. Biomarker levels will be analyzed in both treatment periods and~     compared to baseline, with every patient acting as their own control.~   "
116977|NCT01524861|"~     Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure~     reported to be triggered by stressful events and associated with a distinctive left~     ventricular (LV) contraction pattern.~      SC mimics acute coronary syndrome and is accompanied by reversible left ventricular apical~     ballooning in the absence of angiographically significant coronary artery stenosis.~     sympathetic activity dysfunction appears to play a very important role in the~     pathophysiology of takotsubo cardiomyopathy.~      In most cases, myocardial scintillography with 123Imetaiodobenzylguanidine (MIBG) showed~     altered captation of the radiotracer in several heart segments. In particular, the apical~     myocardium has poor sympathetic innervations and an uptake reduction in MIBG tracer.~      A hypothesis for this finding could be that the intense discharge of adrenalin, acting on~     heart segment with different and abnormal innervation, may produce a transient heart failure~     characterized by a particular shape of the left ventricle.~      While studies have shown that heterogeneous MIBG distribution, decreased MIBG uptake and~     increased norepinephrine content were completely prevented by α-lipoic acid or by L-acetyl~     carnitine administrations in diabetic cardiomyopathy, no studies have examined the effects~     of these therapies on tako-tsubo cardiomyopathy.~      On this basis, the investigators study will evaluate whether the dysfunction of adrenergic~     cardiac innervation, evaluated by MIBG, persist after previous experience of transient~     stress-induced cardiac dysfunction. Moreover, the investigators will assess whether the~     medications that restore sympatho-vagal alterations in diabetic cardiomyopathy, such as~     α-lipoic acid and L-acetyl carnitine, will improve the adrenergic cardiac innervation, in~     patients with SC.~   "
116978|NCT01524848|"~     Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who~     develop resistance against the two hitherto approved drugs for this disease, the tyrosin~     kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further~     response may be achieved by other drugs, mainly other TKIs, which have been explored in~     different studies but not yet have been approved for clinical use. Pazopanib is a TKI~     inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles~     in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves~     investigational trials. The drug is approved for metastatic renal cancer and is relatively~     well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after~     12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough~     levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control~     rate in relation to trough level week 12 and in relation to the primary mutation of the~     tumor (if known). The goal is to include 72 patients in the trial, which is open and single~     arm.~   "
116979|NCT01524835|"~     This study will gather information on the long-term effects of donating a lung lobe on~     living donors.~   "
116980|NCT01524822|"~     Background:~      - Repeated exposure to explosions may lead to changes in the way that people think or feel.~     Breachers (people trained to use explosives to get into buildings) are exposed to repeated~     blasts as part of their job. Researchers want to study how they might be affected by blast~     exposure. Breachers will be compared with other groups who have different levels of exposure~     to repeated blasts. Information will also be obtained from spouses or close companions.~      Objectives:~      - To study the effects of repeated exposure to low-level blasts on thinking, memory,~     behavior, and brain function.~      Eligibility:~        -  Experienced military and civilian breachers, experienced active duty artillery~          operators, and active duty military without frequent blast exposure, 18 and 60 years of~          age.~        -  Spouses or close companions of these individuals.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected and a urine pregnancy test will be required of participants (not~          companions) before MRI scanning.~        -  Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of~          tests each day. Tests will include the following:~        -  Medical and professional history, with questions about exposures to blasts~        -  Tests of thinking, memory, and concentration~        -  Balance tests~        -  Hearing tests~        -  Imaging studies, such as magnetic resonance imaging, to look at the brain~        -  Overnight sleep study to monitor brain waves~        -  Blood samples~        -  Participants will return 1 year later for a 3-day followup visit. Some of the tests~          from before will be repeated. A spouse or close companion (if available) will be asked~          to complete questionnaires or have a telephone interview.~   "
116981|NCT01524809|"~     This trial is conducted in Europe. The aim of this trial is to investigate steady state~     pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects~     with type 1 diabetes.~   "
116982|NCT01524796|"~     Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the~     treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.~   "
116983|NCT01524783|"~     The purpose of this study is to compare the antitumor activity of everolimus plus best~     supportive care versus placebo plus best supportive care in patients with advanced~     nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.~   "
116984|NCT01524770|"~     The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled~     manual syringe, the other given by an auto-injector. Injections will be separated by a~     minimum 28-day washout period. The study will evaluate if the levels of drug in the blood~     are similar when given by each method. Participation in the study is likely to take~     approximately 7 weeks, not including screening.~   "
116994|NCT01524640|"~     This is a randomized, double blind, placebo controlled trial to confirm the safety and~     determine the immune response of the killed oral cholera vaccine in healthy adults and~     children in Ethiopia.~   "
116995|NCT01524627|"~     Varenicline is the best smoking cessation agent to date; however it is only effective in a~     subgroup of smokers and is associated with undesirable side effects in other subgroups. To~     understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion~     functional magnetic resonance imaging and a functional candidate gene association approach~     using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic~     varenicline administration in smokers. Brain and behavioral responses to smoking cues will~     be will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat~     smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats.~   "
116985|NCT01524757|"~     Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in~     excessive iron overload causing damage of different important organs like heart, liver,~     pancreas and joints. Complications and symptoms can regress by intensive treatment reducing~     the iron overload stores.Different genes have been identified playing a role in the~     pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y,~     located on chromosome 6. Phlebotomy is currently the standard therapy which consists of~     removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients~     between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L.~     Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.~      For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the~     ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that~     HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting~     in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.~      Research question: The primary objective is to determine the effectiveness and cost~     effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron~     overload in HH patients.~      Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center,~     Maastricht university medical center ) and hospital in Belgium (University Hospital~     Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up~     will be one year.~      Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the~     ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100~     µg/L).~   "
116986|NCT01524744|"~     The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on~     erosive-atrophic 0ral lichen planus in a randomized clinical trial study.~   "
116987|NCT01524731|"~     Dexamethasone is a synthetic corticosteroid that has been proven to be effective and~     relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV).~      However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis~     after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA~     surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer~     this question, the investigators will conduct a randomized, double-blinded~     placebo-controlled trial with two different doses of dexamethasone in women undergoing~     elective gynecologic laparotomy.~   "
116988|NCT01524718|"~     Hip fractures are one of the most frequent operated fractures procedures in orthopedics,~     with a world wide annual incidence of approximately 1.7 million. These fractures are~     associated with substantial morbidity and mortality. As populations age and life expectancy~     increases worldwide, the incidence of these fractures is likely to raise, expected to triple~     in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an~     integral part of surgical procedures aiming to reduce and fixate the fractured femur. The~     risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery~     is a major slice of the total radiation dose. Optimal positioning and control of the imaging~     intensifier device may result in significant reduction of radiation dose and time and in~     substantial shortening of the procedure.~      The investigators hypothesis is that this technique would substantially shorten procedure~     time and reduce unnecessary radiation exposure for both the patient and the medical staff.~     Furthermore, by using this technique the investigators can eliminate the need for~     fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy~     views.~   "
116989|NCT01524705|"~     Results of recent studies using standard long and short acting insulin therapy (Basal -~     Bolus or BBI) in type 2 diabetes mellitus (T2DM) have not shown benefits to lower risks for~     heart attacks, strokes, or eye, nerve and kidney problems. Some studies also show a long~     time between the start of treatment and signs of benefit. This has led to a review of~     current ways to normalize blood glucose control with basal bolus insulin and how to make~     blood glucose better. Improving blood sugar with insulin therapy usually causes weight gain,~     more high sugar levels after meals, and more low blood sugars. Early studies suggest that~     when people take long-acting insulin and metformin, they have fewer blood sugar extremes~     when they also take a new type of medicine called glucagon-like polypeptide-1 (GLP-1)~     agonist named exenatide (Byetta), instead of meal-time insulin. This means there might be a~     better way to treat Type 2 diabetes.~      Participants are asked to take part in an eight month study to find out if middle-aged and~     older people with Type 2 diabetes who have added risk factors for heart disease can even out~     their blood sugar levels. They will start on long-acting insulin, mealtime insulin, and~     metformin, if they are not already on these medications. Their kidney function tests must be~     normal and they must not be allergic to metformin. Then, after a 2 month run-in phase, they~     must be willing to be assigned by chance into one of two groups. This means that they will~     have a 50/50 chance (like flipping a coin) of being in either group. Half of them will be~     started on the new medicine known as Byetta rather than the meal-time insulin and the other~     half will remain on the meal-time insulin during the next 6 months (26 weeks) to see which~     group has more steady blood sugars. They will be asked to use a continuous blood sugar~     monitoring system called DexCom. A sensor is inserted under the skin in the same areas the~     insulin is injected. The DexCom can check their blood sugars 24 hours of the day and night~     and will be worn until 7 days of recordings are collected. In the same 7 day period, they~     will also be asked to wear a Holter or Telemetry monitor that will record their heart beats~     and rhythm which will be compared to the blood sugar readings. They will also use home~     glucose meters to check their glucose levels about 3 to 4 times a day. The study will take~     place at 12 centers in the United States and enroll about 120-130 people.~   "
116990|NCT01524692|"~     The purpose of this study is to improve survival of patients with recurrent or metastatic~     Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational~     drug, TKI258, in treating ACC.~   "
116991|NCT01524679|"~     A prospective, randomised, open-label phase IIb clinical trial assessing the effect of~     pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing~     nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B~      The primary objective of the trial is to investigate whether the add-on of pegylated~     interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the~     percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48~     weeks.~      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an~     oral antiviral regimen and having a nondetectable viral load for at least 12 months are~     included.~   "
116992|NCT01524666|"~     This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small~     fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of~     Arginine) and monitored for two months. Improvement will be noted on their response to the~     Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by~     performing autonomic function testing at the beginning and end of the study.~   "
117163|NCT01522430|"~     The DEPART study end points are to provide conclusive evidence, using a randomized, double~     blinded, sham procedure controlled study design, that radiofrequency renal denervation:~        1. reduces daytime ambulatory blood pressure,~        2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure~          recording.~   "
116996|NCT01524614|"~     Upper airway obstruction (UAO) is common complication during induction of general~     anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior~     displacement of soft palate are believed to be the primary contributing factors. The~     mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea~     (OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway~     patent in patients with OSA, the investigators hypothesize that nCPAP during induction of~     anesthesia will reduce the incidence and severity of UAO.~   "
116997|NCT01524601|"~     Renal transplant recipients need life long immunosuppression and one of the new drugs is~     everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects~     are increased blood cholesterol levels. Many renal transplant recipients are treated with a~     cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering~     drug on the market with a potential higher cholesterol lowering potency. In the present~     study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol~     levels more than fluvastatin in renal transplant patients.~   "
116998|NCT01524588|"~     Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an~     ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to~     adjust, because an excess of exogenous hormone could lead to very severe complications for~     patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells~     surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.~      The investigators first aimed to research in the c-terminus part of the receptor the~     presence of allelic variants that could explain the variations of response to FSH~     stimulation.~      The investigators also would want to complete the data already known on a functionally~     determinant single nucleotide polymorphism on 680 position in the c-terminus part of the~     hFSHR.~      Then, the investigators would analyze the entire sequence of the hFSHR of patients~     presenting an unusual phenotype in response to FSH treatment, in order to detect a potential~     mutation involved in the receptor functionality.~      The results of this study could allow us to increase our knowledge on the hFSHR physiology~     and functionality, in order to adjust treatment to the genetic profile of patients.~   "
116999|NCT01524575|"~     The goal of this clinical trial is to improve and personalize pancreatic cancer care to~     deliver the most effective therapy while avoiding unnecessary exposure to potential side~     effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression~     predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are~     much more likely to respond to cisplatin than those whose tumors produce large amounts. The~     hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective~     regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of~     ERCC1.~   "
117000|NCT01524562|"~     Background:~      - Liver disease is a leading cause of death in people who have the human immunodeficiency~     virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses.~     Most research on HIV-related liver disease has been conducted in North America and Europe.~     However, HIV-related liver disease in Uganda and other African nations may involve other~     diseases that are not common in the West, and may not involve hepatitis B or C. Researchers~     want to study HIV-related liver disease in Uganda to learn more about the differences~     between Western and African trends of this disease.~      Objectives:~      - To study HIV-related liver disease in rural Uganda.~      Eligibility:~        -  Individuals at least 18 years of age who were tested for possible liver disease. Some~          participants will have HIV infection; others will be uninfected.~        -  All participants will be from rural areas of Uganda.~      Design:~        -  Participants will have at least two study visits.~        -  Participants will have a physical exam and medical history. They will complete a~          questionnaire about health and quality of life. Blood, urine, and stool samples will be~          collected. Participants will also have a liver scan to check for liver scarring, and an~          ultrasound to take images of the liver.~        -  Participants who may have liver disease will visit a local hospital for more tests. A~          liver biopsy will be performed to collect liver tissue samples.~   "
117001|NCT01524549|"~     Background:~      - The endothelium is the inner lining of blood vessels. The cells in this lining help~     regulate blood flow and immune system function. Problems with endothelial cells can~     contribute to heart disease, high blood pressure, and diabetes. Certain genes or parts of~     genes may be related to problems with endothelial function. Researchers want to study~     healthy adults who have genes that may affect their endothelial function. More information~     on these genes may provide more information on genetic risk for certain diseases.~      Objectives:~      - To study healthy adults who have genetic markers related to endothelial cell problems.~      Eligibility:~        -  Healthy volunteers between 18 and 65 years of age.~        -  Current participants of the Environmental Polymorphisms Registry and have certain genes~          related to endothelial cell problems.~      Design:~        -  Participants will have a single study visit to collect information and samples.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have an ultrasound of the artery in the arm and will be given a~          short-acting medication called nitroglycerin to study blood flow and blood pressure.~   "
117002|NCT01524536|"~     Background:~      - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils~     (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart,~     nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage.~     Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although~     most people respond to prednisone, some people develop side effects from it, or do not~     respond very well to treatment. Better ways of determining the dose to give could help to~     decide on the best therapy for HES.~      Objectives:~        -  To determine whether a single-dose of prednisone can be used to predict which people~          with hypereosinophilia respond to treatment.~        -  To study lack of response to steroid treatment in people with HES.~      Eligibility:~      Inclusion criteria:~        -  Individuals with hypereosinophilic syndrome with high eosinophil counts.~        -  Individuals who are willing to have blood drawn before and after getting steroids.~      Exclusion criteria:~        -  Individuals who are on more than 10mg of prednisone (or similar drug)~        -  Individuals with hypereosinophilic syndrome who are on other medications that could~          interfere with the study~        -  Women who are pregnant or breast-feeding~        -  Individuals who have a known gene mutation associated with chronic eosinophilic~          leukemia~        -  Children less than 18 years old who weigh less than 48kg or 106lb~      Design:~        -  Participants will have a screening visit with a physical exam and medical history.~          Blood and urine samples will be collected.~        -  Participants will have a single dose of the steroid prednisone by mouth in the morning.~          Blood samples will be collected 4 hours after this dose.~        -  On the day after the steroid dose, participants will provide another blood sample in~          the morning.~        -  Participants will start to take prednisone daily when they return home. Blood samples~          will be collected weekly at the participant s doctor s office. The dose of prednisone~          will be lowered depending on the weekly eosinophil count. We will try to get each~          person on the lowest dose of prednisone possible that will control the disorder.~          Participants who do not respond or have severe side effects will be taken off~          prednisone. Other treatments will be considered for people who do not respond to~          steroids. The goal is to evaluate the response to prednisone. Our research will try to~          figure out why some people do not respond to steroids. Most people will complete the~          study within 6 to 16 weeks, depending on their response to prednisone.~   "
117003|NCT01524523|"~     Background:~      - Many people feel pain during and after bone marrow aspiration (collection). Studies~     suggest that pain may be related to different kinds of inflammation, or the presence of~     nitric oxide (a normally occurring gas) in the body. Researchers want to study nitric oxide~     levels in the blood and breath before and after bone marrow collection. They will look at~     how these levels relate to feelings of pain.~      Objectives:~      - To better understand pain related to having a bone marrow collection.~      Eligibility:~      - Individuals at least 18 years of age who are enrolled in a study that requires bone marrow~     collection.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood sample.~        -  Participants will provide study blood and breath samples to check nitric oxide levels.~          Participants will also have a test to measure skin sensitivity to heat and touch.~        -  During the collection, participants will keep track of their pain levels.~        -  After the collection, participants will keep track of any pain medications they take.~          They will also record if and when they eat any foods that contain nitrates for about 24~          hours.~   "
117004|NCT01524510|"~     In this open prospective study 40 patients who received Mandibular Replacement Appliance~     (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be~     included. The patient's sleep will be registered during 2 periods of 2 days: one while the~     patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA.~     Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will~     be taken. These data must allow the investigators to validate the use of functional imaging~     (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA~     therapy in OSAHS patients.~   "
117005|NCT01524497|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for~     treatment of depression in Chinese population.~   "
117006|NCT01524484|"~     Data on quality of clinical anesthesia are important for the improvement of both quality and~     patient safety in this field. Routine quality data are often collected by professionals busy~     with patient care. This study examines the reliability of routinely collected quality data~     by comparing the electronic anesthesia record with the respective reports on~     quality-indicating events, i.e. whether events during the anesthetic (e.g., drop of blood~     pressure, irregular heart rhythm, and others) were actually reported or not. Additionally,~     interviews with reporting staff (physicians and nurses) are performed to gain insight in~     possible obstacles to reporting during the working process.~   "
117007|NCT01524471|"~     Spastic esophageal motility disorders induced significant symptoms including dysphagia,~     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel~     approach to perform myotomy through the esophagus with long submucosal tunnel. This study~     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques~     from animal study to clinical practice in human.~   "
117008|NCT01524458|"~     rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms~     to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The~     commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive~     lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES).~     Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary~     esophageal motility disorder in which the LES failed to relax with increased pressure.~     Currently the standard treatment for Achalasia and spastic motility disorders is~     Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery~     (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy~     (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after~     identification of the level of gastroesophageal junction. Myotomy will be performed with~     endoscopic instruments and the entrance site will be closed with clips.~   "
117009|NCT01524445|"~     The purpose of this retrospective study is to collect information about patients who~     received bortezomib as their first chemotherapy and who responded well to it, but who~     relapsed afterwards and were treated again with bortezomib a second time after a~     treatment-free period of at least 6 months. During this non-interventional study (this means~     that no drug is being tested in this study) the safety and effectiveness (whether it works~     or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma. Only~     data already mentioned in your clinical file will be collected. About 100 adult patients~     will take part in the study~   "
117010|NCT01524432|"~     This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects~     with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study~     which has a 2 week treatment period and a 4 week follow-up evaluation.~   "
117011|NCT01524419|"~     1. Increased women's involvement in decision making at labor process correlates with a~          positive perception of the labor process.~        2. Increased maternal satisfaction with midwifery and gynecological care at labor~          correlates with a more positive perception of the labor process.~   "
117012|NCT01524406|"~     This is a safety and tolerability study investigating the effect of HPP593 in healthy~     volunteers during and after limb immobilization.~   "
117013|NCT01524393|"~     Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has~     been reported in numerous case reports and in two small consecutive series. The incidence of~     venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of~     VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).~      The aim is to estimate and compare the risk of both PE and VTE during the the different~     phases of pregnancy after IVF to that in age and period matched control women. The~     investigators will use the Swedish National Health Registers to estimate the risk.~   "
117014|NCT01524380|"~     A double-blind, randomized, placebo-controlled trial of ginkgo biloba extract (Egb-761) as~     an add-on therapy to risperidone compared to risperidone plus placebo in the treatment of~     200 treatment-naive first-episode patients with schizophrenia. The study addresses an immune~     dysfunction hypothesis of schizophrenia.~   "
117177|NCT01522248|"~     Some people experience symptoms just after receiving the seasonal inactivated influenza~     vaccine. The cause of some of these symptoms is likely to be an immune response to the~     vaccine. The investigators would like to look at the earliest immune responses to the~     inactivated influenza vaccine. This pilot study will help us to determine at what time~     points we should look.~   "
117015|NCT01524367|"~     Excitement during the emergence from general anesthesia is a great post-operative problem.~     It may lead to serious consequences for the patient, such as injury, increased pain,~     hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or~     chemically restraining the patient. It has been reported that the incidence of postoperative~     emergence excitement in adults after general anesthesia is 21.3% occurrence.~      Many things are mentioned as risk factors for emergence excitement. Among them, excitement~     after orthognathic surgery (two-jaw) was more common than after other types of surgery. The~     patients undergoing emergence with nasotracheal intubation after orthognathic surgery may~     have a sense of suffocation during emergence from anesthesia, which may increase the~     incidence of emergence excitement.~      Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an~     S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1)~     compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.~      To the best of the investigators knowledge, effect of dexmedetomidine on emergence~     excitement was investigated only in children.~      The investigators hypothesized that single dose of dexmedetomidine would reduce the~     incidence and the severity of the emergence excitement in adults with nasotracheal~     intubation after orthognathic surgery (two-jaw).~   "
117016|NCT01524354|"~     The aim of our study was to evaluate the significance of monitoring anesthetic depth for the~     conduct of anesthesia and the early postoperative period in patients subjected to surgical~     correction of combined valvular disorders.~   "
117017|NCT01524341|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30~     mg/day~   "
117018|NCT01524328|"~     The purpose of this study is to investigate the proportion of use of complementary and~     alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition,~     the reason for, and satisfaction with use of CAM.~   "
117019|NCT01524315|"~     The objective of this study is to determine whether preoperative parenteral thiamin~     supplementation does prevent the intra and early postoperative increase of lactate and~     whether this effect is related to the extent of thiamine deficiency in patients undergoing~     heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing~     heart surgery will be determined.~   "
117020|NCT01524302|"~     This study will further analyze the use of ceftaroline for CABP and compare its potential to~     eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of~     ceftaroline compared to levofloxacin may be further highlighted from this investigation.~   "
117021|NCT01524289|"~     The objective of this study is to evaluate the efficacy and tolerability of adding~     anacetrapib to ongoing statin therapy in participants with heterozygous familial~     hypercholesterolemia.~   "
117022|NCT01524276|"~     The purpose of the Registry is to provide continuing evaluation and periodic reporting of~     safety and effectiveness of Medtronic market-released products. The Registry data is~     intended to benefit and support interests of patients, hospitals, clinicians, regulatory~     bodies, payers, and industry by streamlining the clinical surveillance process and~     facilitating leading edge performance assessment via the least burdensome approach.~   "
117023|NCT01524250|"~     Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose~     corticosteroids are already been chosen by the patient and the diagnosing physician will be~     contacted for screening and enrollment. Patients will then be randomized to receive~     equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve~     function assessments will be compared at baseline, prior to treatment, one and six months~     post corticosteroid treatment. This will allow for a comparison on whether the route of~     medication plays a role in the effectiveness of treatment with high dose corticosteroids.~   "
117024|NCT01524237|"~     This study will be comprised of 2 parts, Part A and Part B, both in healthy male~     participants.~      Part A of the study will investigate the safety of intravenous (IV) ketamine administration~     after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be~     completed before starting Part B.~      Part B of this study will investigate whether different dose levels of LY2979165 or~     LY2140023, when administered before ketamine, result in changes to the images on a brain~     scan seen with ketamine alone. Brain imaging is currently used for a number of reasons~     including understanding where in the brain medicines have their effects. Ketamine is an~     anesthetic used in this study to activate particular regions of the brain.~      The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg~     with matching dummy drug (placebo) for each dose.~      The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.~      Screening is required within 28 days prior to the start of the study and follow up 7-14 days~     after the last dose of study drug. The study will last up to 8-weeks for an individual~     participant.~   "
117025|NCT01524224|"~     This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV)~     LY2495655 in participants with advanced cancer.~   "
117026|NCT01524211|"~     The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular~     stent-graft system for the treatment of aortic aneurysms.~   "
117033|NCT01524120|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal~     disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several~     macroscopic and histologic features including patterns of inflammation, crypt abscesses and~     granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for~     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy~     of the gastrointestinal mucosa during the endoscopic procedure.~      The main objective of this study is to determine endoscopic and endomicroscopic features of~     mucosal healing in patients with IBD.~   "
117034|NCT01524107|"~     The medical literature does not provide sufficient information or recommendation regarding~     specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to~     compare maternal and neonatal morbidity of women who have undergone urgent Caesarian~     Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order~     to develop a standard treatment protocol. The Medical Record review will include many~     parameters including complications, type of antibiotic usage etc.~   "
117483|NCT01518244|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular~     hypertension.~   "
117027|NCT01524198|"~     Asthma is the most common chronic illness of childhood. About 10% of children are affected.~     Not surprisingly, acute asthma exacerbations are one of the common reasons to visit~     pediatric emergency rooms (ER). About 5.7% of all pediatric emergency room visits are due to~     acute asthma exacerbation. Around 8% of those get admitted to the hospital. This constitutes~     huge financial and administrative burden on the health care system.~      Inhaled corticosteroids (ICS) is the gold standard prophylactic therapy for patients with~     persistent asthma. In the setting of acute asthma exacerbation systemic steroids given early~     in the course of treatment help decrease the rate of admission and return to the ER.~     However, the anti-inflammatory action of corticosteroids, through which this effect is~     caused, takes 4 hours to start working. This is because it is mediated through genomic~     pathways where the transcription of several inflammatory cytokines is suppressed. It was~     also shown that corticosteroids can cause vasoconstriction through non-genomic pathways. The~     onset of this action is as quick as 30-60 minutes. It is proposed that this action is~     mediated by blocking the extraneuronal uptake (metabolism) of norepinephrine in vascular~     smooth muscle cells, hence, making it available for re-use by the sympathetic neuronal~     cells.~      Our objective is to compare the efficacy of adding repetitive sequential doses of budesonide~     versus placebo (normal saline (NS)) to β2-agonist and ipratropium bromide (IB) combination~     (standard treatment) in the management of acute asthma in children in the ER. We hypothesize~     that the addition of budesonide to β2-agonist and IB in the management of moderate to severe~     acute asthma in the ER is superior to the addition of placebo.~   "
117028|NCT01524185|"~     Children who have been exposed to trauma (defined as physical, sexual or emotional abuse,~     neglect, exposure to life threatening events, domestic and community violence, parental~     mental health disorders, substance abuse, and/or incarceration may also have parents who~     have experienced trauma. Often, unresolved intergenerational trauma makes treatment of~     children with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment~     disorders and dysregulation characterized by emotional lability, hyperarousal, and sleep and~     attention disturbances, difficult to manage. FamilyLive (FL) is a promising treatment~     approach developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years~     ago to address the unique needs of families with unresolved and untreated histories of~     neglect and disrupted attachment who need support to build skills for managing their~     children's responses and behaviors. FL uses a team approach with a therapist in the room~     with the family and call-in observations and clinical suggests from a clinician behind a~     one-way mirror. Through the call-in process the treatment team provides validation,~     acknowledgement, support and multiple perspectives for the family's experiences. The FL~     approach works with families to improve parental self-care, stress management, emotional~     regulation and self-awareness.~      Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been~     systematically evaluated using a randomized design. The proposed preliminary study will use~     a randomized design to evaluate the feasibility of conducting a larger randomized trial of~     FL compared to other standard mental health care treatments (SMHC) at the KKFC. We~     hypothesize that it will be feasible to recruit sufficient numbers of clients for and~     conduct a randomized controlled trial of FL on a cohort of children exposed to neglect and~     trauma. We also hypothesize that FL participants will evidence greater reductions in heart~     rate variability, behavior problems, trauma symptoms, and improvements in functioning~     compared to participants in the SMHC.~   "
117029|NCT01524172|"~     This preliminary study will examine the feasibility of conducting a randomized clinical~     trial of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment~     compared to SCMH for children ages 8-12 years who have a history of neglect and maltreatment~     (trauma). The goal of the study is to inform the method and sample size for a larger~     randomized trial to study the effect of YMBT with SCMH compared to SCMH in improving child~     regulation of behavior, emotions, and daily functioning. Children who have experienced~     trauma, including sexual abuse, physical abuse, emotional abuse, exposure to community or~     domestic violence, parental substance abuse, mental health disorders, and incarceration are~     at risk to have dysregulation of mood, emotions and behavior. In addition, children exposed~     to neglect and trauma may have poor attachment to caregivers and poor peer relations. It is~     hypothesized the using YBPG as an adjunct to SCMH may improve children's regulation of~     emotion and behavior.~   "
117030|NCT01524159|"~     The purpose of the study is to evaluate the effect of dietary supplementation of bromelain~     (a proteolytic enzyme from the pineapple plant) on the reduction of plasma fibrinogen level~     among type 2 diabetic subjects who have a high risk of cardiovascular disease.~      The null hypothesis [Ho] is: there is no significant improvement in plasma fibrinogen, serum~     lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for subjects~     with type 2 diabetes who are at risk of CVD following the intervention of bromelain~     supplementation compared to placebo group.~      The alternative hypothesis [H1] is: there is a significant improvement in plasma fibrinogen,~     serum lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for~     subjects with type 2 diabetes who are at risk of CVD following the intervention of bromelain~     supplementation compared to placebo group.~   "
117031|NCT01524146|"~     Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma~     in the United States. Several European studies have reported the efficacy and safety of~     Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported~     the same in the United States.~      The establishment of a registry to capture all PDT cases within and outside US can help the~     investigators evaluate a larger and non-ambiguous sample population. This would help the~     investigators evaluate the technical success rates, clinical success rates, feasibility and~     safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as~     a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need~     to further evaluate the efficacy and safety of such combined procedures as well. The~     ultimate objective is to assess if PDT with or without additional or adjuvant treatment~     options prolongs survival duration and improves quality of life in patients with~     unresectable cholangiocarcinoma.~      This multicenter registry has been initiated:~        -  To document the impact of PDT on the clinical management of unresectable~          cholangiocarcinoma.~        -  To assess the clinical and technical success rates of PDT for unresectable~          cholangiocarcinoma.~   "
117032|NCT01524133|"~     The current research study aims to compare the effectiveness of two proven treatments for~     posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their~     combination. In addition, the investigators are examining predictors of response to these~     two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by~     such treatments. Biological mechanisms of change are also examined including emotion~     processing and regulation in fMRI, HPA axis function, and genetics and genomics. In~     addition, the investigators will examine acceptability of each treatment and reasons for~     ending treatment.~   "
117484|NCT01518231|"~     The purpose of this study is to evaluate the safety and efficacy of autologous peripheral~     hematopoietic stem cell transplantation in ischemic stroke.~   "
117036|NCT01524081|"~     Aim of prospective randomized a placebo controlled study is to prove that in case of acute~     surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel~     and stomach appropriately administered antibiotic prophylaxis is effective with lower~     incidence of infection in surgical site and comparable risk of development of other~     nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to~     determine risk of developing nosocomial infection in the above mentioned group of patients,~     identify group of patients which does not benefit from prophylaxis, and compile financial~     costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the~     background for the recommended procedure with regards that such prospective study does not~     exist in the Czech Republic.~   "
117037|NCT01524068|"~     This is a randomized, multi-center, open-label Phase II clinical trial to determine the~     efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid~     administration, in comparison to corticosteroids alone, among patients with acute Idiopathic~     Pulmonary Fibrosis (IPF) exacerbations.~      The investigators central hypothesis is that antibody-mediated autoimmunity can play an~     important role in IPF exacerbations. The investigators propose to test our central~     hypothesis by establishing the efficacy of autoantibody removal by plasma exchange (PEX), in~     conjunction with B-cell depletion by rituximab to deplete immunoglobulins and minimize their~     further production, among patients with acute IPF exacerbations.~      The primary goal of this randomized, multi-center, open-label Phase II clinical trial is to~     determine effects of combined plasma exchange (PEX), rituximab, and conventional~     corticosteroid administration on selected, relevant immunological parameters, in comparison~     to effects of steroids alone, among AE-IPF patients. The investigators anticipate the~     findings of this will lead to larger incremental trial(s) to determine actual clinical~     efficacy of this treatment.~      A total of 40 subjects will be enrolled in this multi-center trial from 5 participating~     medical centers.~   "
117038|NCT01524055|"~     Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel.~     In 2008, a novel balloon-assisted enteroscope system has been developed using only a single~     balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and~     treatment of the small bowel. The investigators could demonstrate the both endoscopic~     procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic~     procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the~     bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas~     insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air,~     however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy,~     significant amounts of air are usually retained in the bowel segment inspected. This air has~     to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and~     discomfort during and after the examination due to the retention of air have been shown to~     be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air,~     is rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed~     from the GI tract. The use of CO2 has been shown to result in more comfortable examinations~     in both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these~     studies, CO2 insufflation had almost completely reduced procedure-related pain and~     discomfort.~      In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE.~     Another group confirmed our findings. To our knowledge, no study has been performed~     investigating the use of CO2 in SBE.~      The aim of the present study is to examine whether CO2 insufflation leads to a reduction of~     abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2~     insufflation facilities a deeper intubation of the endoscope, as shown for the DBE~     technique.~   "
117039|NCT01524042|"~     Recently colonoscopy has gained importance as screening programs for colon polyp, cancer and~     inflammatory bowel disease in the United States and other countries. The number of~     colonoscopy performed has been increased year by year. To make an increased compliance with~     colonoscopy in both screening and clinical surveillance programs, consideration of anxiety,~     shame and satisfaction in examinee is regarded to be important. During colonoscopy patients~     wear conventional single pants where there is no hole for insertion of scope. Patients take~     off the conventional single pants below the buttocks and expose their buttocks and perianal~     area during colonoscopy. Exposing perianal and perineal area during colonoscopy can make~     patients feel shameful and anxious and diminish satisfaction of colonoscopy. Recently~     considering the factors affecting satisfaction has been regarded to be important because~     patient satisfaction could be one of the quality indicators for colonoscopy. To diminish~     shame and anxiety by exposing perianal and perineal area of patients wearing conventional~     single pants during colonoscopy, we developed novel double pants with a hole in inner pants.~     Novel double pants are composed of double fabrics from hip to thigh and single fabric under~     the thigh such as common pants. In the inner pants of double pants, there is a hole for~     insertion of scope. The hole is 25 cm wide and 15 cm long. The outer pants are same as~     conventional single pants. If the patients dropped outer pants below hips, only hip and~     perianal area are exposed through the hole (25cm*15 cm) for insertion of scope without~     dropping inner pants. Therefore novel double pants minimized the exposed area of hips than~     conventional single pants because hips are exposed only the hole of inner pants. Smaller~     exposed area of hips by novel double pants can minimized the shame and anxiety by~     diminishing exposing perianal and perineal area during colonoscopy. Therefore advantage of~     novel double pants is decreasing shame and anxiety and increasing satisfaction by minimizing~     the exposed area of perianal and perineal area compared with conventional single pants. This~     study is a randomized controlled study. The investigators will survey the examinees older~     than 20 years who performed the colonoscopy at Severance Hospital from Feb. 2012 to Jul.~     2012 to compare the effect on the satisfaction, shame, and anxiety during colonoscopy~     between the two groups.~   "
117040|NCT01524029|"~     The goal of this study is to determine the value of the new mammography technique called~     Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital~     Mammography for the early detection of Breast Cancer.~      DBT is able to compute a three-dimensional image of a breast from several low-dose~     mammographies taken from different angles while the device is moving around the breast in a~     circular motion. This should overcome a significant limitation of Digital Mammography~     arising from the masking of breast cancer in a mammography image caused by overlying normal~     breast tissue.~      This is a study conducted in several Austrian Breast Imaging Centers.~   "
117041|NCT01524016|"~     Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin~     receptor positive mesenchymal tumor, which is frequently hidden in an unusual anatomical~     site and often goes undetected by conventional imaging. A permanent cure of the disease~     relies on exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a~     novel scan that might have improved sensitivity and resolution specifically for somatostatin~     receptor positive tumors. The investigators will scan the suspicious and confirmed patients~     of oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to~     see if it improves patient care.~   "
117042|NCT01524003|"~     The purpose of this study is to develop and implement a community based preventive~     healthcare model using cervical cancer screening as the target medical intervention.~      The investigators will first conduct 2 pilot studies to refine their preventive healthcare~     model based on the principles of community based participatory research (1000 participants).~     The investigators will then apply the model to screen 9000 women for cervical cancer over a~     period of 7-9 days. This 10,000 patient trial will explore the ability of a community to~     conduct their own screening program to identify who needs medical intervention based on~     self-collection and centralized high-throughput low cost human papillomavirus (HPV) testing.~   "
117043|NCT01523990|"~     A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1~     Infected Patients~   "
117178|NCT01522235|"~     The purpose of the study is to see if administering intravenous immune globulin (IVIG)~     (putting immune globulin directly into your blood) helps to improve the symptoms of~     orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality~     of life in men and women who have autoimmune autonomic ganglionopathy (AAG).~   "
117044|NCT01523977|"~     Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent~     tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus~     is approved for use in the United States for certain types of cancer, such as kidney cancer.~     It has been extensively studied in people with various types of cancer as a single agent (a~     drug that is used alone to treat the cancer) or in combination with a number of other drugs.~     Studies in adults with cancer have also evaluated Everolimus in combination with other~     anti-tumor drugs. Information from lab studies and some other clinical trials suggests that~     Everolimus may kill leukemia cells on its own, and also make it more likely that steroids~     (such as prednisone) are able to kill leukemia cells.~      In this research study, we are looking to learn more about how Everolimus works in~     combination with other drugs which are commonly used to treat relapsed acute lymphoblastic~     leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the~     study is to evaluate the side effects of this treatment combination in order to determine a~     safe dose of Everolimus which can be given with these other 4 drugs.~   "
117045|NCT01523964|"~     Physicians seek a method to assess neuromuscular disease that is both non-invasive and~     quantifiable. Many patients do not tolerate standard current day assessment tools (such as~     needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve~     as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful,~     these devices will allow for improved ability to diagnose neuromuscular disease and to~     assess disease progression or remission, allowing for better care of individual patients as~     well as for use in clinical trials, where improved outcome measures for neuromuscular~     diseases is being sought.~   "
117046|NCT01523951|"~     Aim of the study is to demonstrate superiority of a continuous cooling of the skin over~     topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8%~     patch (Qutenza).~      Secondary it will be tested, if the 2 different pre-treatments have an effect on the~     application pain within the first 24 hours, and if different pre-treatments have an effect~     on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza~     application.~   "
117047|NCT01523938|"~     The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac~     or spinal column surgery. A particular aim is to point out the effects on postoperative~     cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac~     stratum).~   "
117048|NCT01523925|"~     This project attempts to perform a randomized controlled trial to verify the efficacy and~     motor control mechanism of the proposed combined functional electrical therapy with~     distributed constraint-induced therapy or with robot-assisted Bilateral training.~   "
117049|NCT01523912|"~     The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the~     follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the~     last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment~     of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been~     studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the~     treatment of dysplastic gastric mucosa.~   "
117050|NCT01523899|"~     This study expands upon pilot data for feasibility since May 2011. The study aims to~     evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for~     non-MRSA abscesses in ambulatory patients in the Emergency Department (ED). The~     multi-institutional study will assess the feasibility of providing the GeneXpert® MRSA/SA~     SSTI assay to the ED and evaluate the impact of delivering the test result to clinicians in~     real-time on patient management decisions regarding the use of antimicrobial agents.~     Patients are randomized to standard culture (control arm) or to the GeneXpert® assay plus~     standard culture.~   "
117051|NCT01523886|"~     The purpose of this investigation is to compare the surgical conditions during laparoscopic~     cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.~      The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are~     better with deep muscle relaxation than moderate muscle relaxation.~   "
117052|NCT01523873|"~     The main purpose of this study is to prospectively assess the general safety profile of~     Dotarem~   "
117053|NCT01523860|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine +~     Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.~   "
117054|NCT01523847|"~     The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the~     cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is~     substituted for doxorubicin in the conventional ABVD regimen.~   "
117055|NCT01523834|"~     Treatment of adult patients with Diffuse Large B-cell Lymphoma (DLBCL), relapsed or~     refractory to previous CHOP-R (or CHOP-R like regimen) front line therapy, relapsed or~     refractory to second or subsequent salvage therapies which included high dose therapy with~     autologous stem cell support (ASCT).~      Treatment of adult patients with DLBCL relapsed or refractory to front line therapy with~     CHOP-R (or CHOP-R like regimen) or subsequent treatments, who are not consider eligible for~     ASCT consolidation because of age, co-morbidities, impossibility to perform ASCT.~      The trial is conducted according to the optimal two-stage design of Simon with alpha 0.05~     and beta 0.10, considering the following two hypotheses: first a response rate (RR) less~     than 10% is of no further interest; and second, an RR 30% is clinically meaningful. In the~     initial stage, 18 patients have to enter onto the study. If less than 3 responses (</=2 in~     18) will be observed, the trial would be terminated. Otherwise, accrual will continue to a~     total of a maximum of 35 patients. At the end of the trial, if 6 or fewer responses will~     occur among the 35 patients (</= 6 in 35), it will be concluded that the regimen is not~     worthy of further investigations for that group of patients.~      The treatment is divided in three phases: induction phase (course 1 to 6), consolidation~     phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any~     reason).~   "
117056|NCT01523821|"~     This phase I/II trial studies the side effects and best dose of alpha 1 anti-trypsin~     (alpha-1-proteinase inhibitor human) and to see how well it works in treating patients with~     acute graft-versus-host disease (GVHD). Alpha-1-proteinase inhibitor human may be a better~     treatment for graft-versus-host disease caused by a stem cell transplant.~   "
117057|NCT01523808|"~     The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo~     studies data showing an anti-neoplastic effect on pancreatic tumor cell lines.~     Interestingly, these studies suggest an additional effect of L-asparaginase associated to~     gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim~     of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on~     locally advanced or metastatic pancreatic tumors, after therapy failure of first or second~     line chemotherapy using gemcitabine.~   "
117058|NCT01523795|"~     The purpose of this study is to determine whether playing motion-controlled video games~     produces low caloric intake and higher caloric expenditure than watching TV or playing~     traditional video games.~   "
117059|NCT01523782|"~     There is not clinical validation that the benefits of L-asparaginase can offers during~     induction chemotherapy for elderly patients, where prevent toxicities is critical.This Phase~     IIa clinical trial propose to evaluate, specifically for elderly patients, the tolerated~     dose of GRASPA® in combination with a poly chemotherapy treatment which enables efficient~     L-asparagine depletion for a period at least equal to 7 days.~   "
117060|NCT01523769|"~     Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these~     infants have higher circulating blood volume in the first 24 hours, less need for blood~     transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord~     clamping has also been shown to increase the initial hematocrit and decrease the need for~     red blood cell (RBC) transfusions compared with no intervention in infants born between 27~     and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may~     theoretically interfere with neonatal resuscitation. There have been few studies that~     addressed the active milking of the cord and its effect on neonatal resuscitation. Active~     milking of the umbilical cord towards the baby prior to clamping (rather than passive)~     should take less than 5 seconds to perform and should not interfere with neonatal~     resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been~     shown to increase the circulatory blood volume expressed as the hemoglobin value. Active~     milking of the cord prior to clamping, however, is not considered standard of care and only~     1 Japanese randomized control study has reported that umbilical cord milking reduces the~     need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion~     as compared with control conditions. Our study aims to test the hypothesis that active~     milking of the umbilical cord will reduce the need for transfusion in preterm infants.~   "
117061|NCT01523756|"~     This is an open-labelled randomized cross-over and controlled exploratory intervention that~     aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy~     appliances each for two weeks. During the test a questionaire is to be filled out and~     interviews will take place. Primary parameter is leakage. A Study nurse will visit the~     participants in their homes every two week during the test.~   "
117062|NCT01523743|"~     The purpose of this study is to compare compact intermittent catheters with standard coated~     intermittent catheters with regard to quality of life, using the Intermittent~     Self-Catheterisation Quality of life Measure.~   "
117063|NCT01523730|"~     Cigarette smoking rates are extremely high in persons with schizophrenia and this increases~     the risk of disease and death due to tobacco-related disorders. One of the features of~     schizophrenia is reduced cognitive abilities, such as poor attention and memory. It is~     thought that people with schizophrenia smoke cigarettes to reduce these cognitive problems,~     as nicotine can improve cognitive function in these people. When people with schizophrenia~     stop smoking it causes further cognitive difficulties, which makes quitting harder for them~     compared to people without schizophrenia. A method called repetitive transcranial magnetic~     stimulation (rTMS) allows clinicians to give repeated magnetic pulses through the scalp to~     cause changes in brain activity and behaviour. rTMS can improve cognitive function in people~     with schizophrenia. Studies have also shown that rTMS can reduce tobacco craving and~     consumption of cigarettes. Therefore, we believe that rTMS will improve the cognitive~     deficits observed during cigarette smoking abstinence and help reduce cravings for~     cigarettes. Ultimately, rTMS may help smokers with schizophrenia who can't quit smoking with~     available treatments. This study will examine the effect of rTMS on tobacco cravings and~     cognitive problems produced by overnight abstinence from cigarette smoking in persons with~     schizophrenia in comparison to people without mental illness who smoke. Important~     information about the potential of rTMS for the treatment of cognitive deficits and tobacco~     addiction in schizophrenia will be obtained. Providing more effective smoking cessation~     treatments in people with schizophrenia may lead to improved physical and mental health for~     these patients, who are extremely susceptible to tobacco addiction and tobacco-related~     illness.~   "
117064|NCT01523717|"~     The purpose of this study is to investigate the relationship between a procalcitonin~     decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.~   "
117065|NCT01523704|"~     The number of patients with implantable pulse generator (IPG) has steadily increased in~     Japan causing increment in number of in office follow-ups and greater burden on many~     hospitals.~      The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home~     Monitoring system reduces office follow-up visits without compromising patient safety.~      Patients will be randomized into HM follow-up only (Group 1) or HM & in-office follow-up~     (Group 2) and will be followed-up for 27 months.~   "
117066|NCT01523691|"~     Goal of this study is to test the hypothesis that repeated exposure to cycles of~     insufficient sleep increases susceptibility to a variety of disease states by progressively~     compromising the integrity of stress response systems.~   "
117088|NCT01523405|"~     This is a non-interventional, cross sectional, multicentric study in T2DM patients which~     will involve a single visit for study related procedures. This study will be conducted in~     approximately 5,000 patients at around 300 hospitals/primary care clinics across India.~     Approximately 18-20 patients per site will be enrolled. This study has been designed to~     evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in~     relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM~     patients on oral / injectable anti-diabetic drugs with/without insulin therapy.~   "
117089|NCT01523392|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African~     American patients with stable coronary artery disease.~   "
117067|NCT01523678|"~     Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly~     paclitaxel/carboplatin regimen in gynaecological cancers.~      Purpose: This multicenter phase II trial is studying the side effects of weekly~     paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent~     epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or~     cervical carcinoma. Data obtained in this trial will be compared with historical data as~     published earlier.~      The trial will include 3 cohorts of 36 patients:~        -  Subjects with ovarian, fallopian tube or peritoneal carcinoma~        -  Subjects with endometrial cancer~        -  Subjects with cervical carcinoma~      Treatment:~      Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously~     weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and~     possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles~     of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next~     2 years and then if clinically indicated. Subjects who develop disease progression will~     discontinue therapy. Subjects who have no evidence of disease progression after completion~     of study therapy will be followed until disease progression, withdrawal of informed consent,~     or death.~   "
117068|NCT01523665|"~     Glucose metabolism is impaired in many critically ill patients and is often aggravated by~     parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion~     protocols, which are based on frequent bedside glucose monitoring, have been implemented on~     most critical care units. Despite extensive efforts of the intensive care unit staff~     difficulties were experienced in achieving efficient and safe glucose control. Several~     barriers to the implementation of glycemic control have been identified. Most importantly,~     there is concern about increased frequency of severe hypoglycemic episodes. To overcome~     these problems Space GlucoseControl was developed as a decision support system which helps~     to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l~     or 4.4 - 8.3 mmol/l).~      The objective of this non-interventional study is to gain additional information on the~     performance of the Space GlucoseControl system for glycaemic control in ICU patients when~     used in routine clinical practice.~   "
117069|NCT01523652|"~     The purpose of this study is to determine whether HGF serum concentration might be raised in~     vivo by administering nadroparin given with prophylactic purpose to gynecological patients.~   "
117070|NCT01523639|"~     This multicenter randomized, placebo-controlled phase II study will enroll 132 first-line~     palliative treated subjects with metastatic KRAS wild type CRC. Subjects with histologically~     confirmed, KRAS wild-type CRC without previous chemo-therapy for metastatic disease will be~     screened for this study.~      Approximately 10 sites in Austria will participate in the study. Subjects will be randomized~     in a ratio of 1:1 into two groups.~   "
117071|NCT01523626|"~     Computed tomography (CT) scanning has become essential in the early diagnostic phase of~     trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT~     scanners and infrastructural improvements made 'total body' CT scanning (TBCT) technically~     feasible and its usage is currently becoming common practice in several trauma centers.~      However, literature provides limited evidence whether immediate 'total body' CT scanning~     leads to better clinical outcome then conventional radiographic imaging supplemented with~     selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the~     value of immediate TBCT scanning in trauma patients.~      The investigators hypothesize that immediate 'total body' CT scanning during the primary~     survey of severely injured trauma patients has positive effects on patient outcome compared~     with standard conventional ATLS based radiological imaging supplemented with selective CT~     scanning.~   "
117072|NCT01523613|"~     The purpose of this study is to extend our knowledge concerning the clinical performance of~     two dental filling materials in molars. The study will compare two high-strength~     glass-ionomer filling materials.~      The investigators hypothesize that after two years (1) the clinical performance of both~     filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar~     or higher incidence of fracture than Fuji IX GP fillings.~   "
117073|NCT01523600|"~     The purpose of this randomised (double-blind) controlled exercise intervention trial is to~     determine whether the whole body vibration (WBV) training can effectively improve physical~     functioning of older people living in or regularly using services of sheltered housing,~     reduce their fear of falling, and prevent falling. The study comprises a 10-week training~     period and a 10-month follow-up period.~   "
117074|NCT01523587|"~     This randomised, open-label phase III trial will be performed in patients with advanced~     squamous cell carcinoma of the lung requiring second-line treatment after receiving~     first-line platinum-based chemotherapy. The primary objective of this trial is to compare~     the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.~   "
117075|NCT01523574|"~     Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part~     of many chemotherapy regimens for the treatment of several gastrointestinal malignancies.~     One of the most important limitations to its use is the induction of both acute and chronic~     peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the~     incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to~     determine if vitamin E could also prevent Ox-induced acute PN~   "
117076|NCT01523561|"~     The aim of this study is to evaluate if creative dance twice weekly can influence girls~     wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic~     problems and/or stress.~      Specific objectives are~        -  To assess the effect of the dance intervention in reducing psychosomatic problems (such~          as pain in the head, neck, shoulder or stomach), stress and depression~        -  Determine which factors are important for continuing dancing and keeping up new habits~        -  A cost-effectiveness analyse of the health outcome.~      Geographical area: Örebro County (population 276,000)~   "
117090|NCT01523379|"~     The complex regional pain syndrom is a weighty disease that often results in a lifelong~     disability. Mostly this disease appears unilateral after comparatively mundane fractures or~     operations. In early stages CRPS shows inflammatory processes. These inflammatory components~     can be seen as edema and vasodilatation. These inflammatory processes lead us to the~     hypothesis that selective COX-2-inhibitors might help patients with CRPS.~   "
117091|NCT01523366|"~     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic~     patients with stable coronary artery disease.~   "
117077|NCT01523548|"~     The purpose of this study is to examine the potential of carbon monoxide (CO) to decrease~     elevated blood pressure in the pulmonary artery. This symptom is seen in patients with~     pulmonary arterial hypertension, a rare disease that causes fatigue, dizziness, and~     shortness of breath because the blood vessels that supply the lungs narrow, forcing the~     heart to work harder to push blood through. Previous studies in the laboratory have shown~     that carbon monoxide has promise in treating these symptoms.~      Subjects in this study are being asked to undergo a new type of treatment to improve~     pulmonary arterial hypertension by breathing CO gas. CO is a colorless, tasteless, odorless~     gas usually found in car exhaust or cigarette smoke. It is administered with a continuous~     flow of air. Subjects will undergo a screening process during which it will be determined if~     they are eligible for the study. After the screening process, if subjects meet eligibility~     criteria for the study, they will begin carbon monoxide treatment through a cushioned mask~     that is placed over the nose and mouth. This treatment will last for sixteen weeks.~   "
117078|NCT01523535|"~     The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to~     stay. Americans are working more and more, frequently at multiple jobs. The pattern of short~     sleep during the week followed by attempts to recover on the weekend is in common practice,~     but we know little of the associated health risks. What is the cost in terms of increasing~     known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and~     is this cost compounded with repetition, without adequate recovery? Evidence is accumulating~     to suggest that short sleep duration is linked to the development of metabolic and~     inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the~     development of cardiovascular disease include impaired vascular function and inflammation.~     The current proposal is designed to investigate the effects of repeated periods of short~     nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep~     opportunity per night), and each cycle of short sleep followed by a single night of recovery~     sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation,~     and microcirculatory vasodilation will be assessed using perfusion imaging techniques. The~     dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function,~     will also be investigated.~   "
117079|NCT01523522|"~     This project aims to offer autologous muscle-derived progenitor cell injection as an~     efficient mini-invasive surgical therapy that would be simple for the patient and could be~     used in a majority of cases, including in young women in the post-partum. This approach may~     provide efficient tissue repair of the striated anal sphincter which is not permitted by~     existing therapies. This innovative therapy may ultimately be proposed after failure of the~     common treatments and before an high-risk invasive surgical intervention. Besides, injection~     of muscle-derived progenitor cells in animals has shown very encouraging results of the~     sphincter function assessed ex vivo. Hence, a high benefit may be expected with this~     approach.~   "
117080|NCT01523509|"~     The proposed test is intended to enable dentists to differentiate between cavitated and~     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).~     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays~     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low~     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,~     pain, root canals, and possible later loss of teeth.~      Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of~     early cavitation from 58% to 90%.~   "
117081|NCT01523496|"~     The purpose of this study is to determine the correct dose of Vitamin D to give to prevent~     HIV related complications.~   "
117082|NCT01523483|"~     The investigators study objective is to investigate the effectiveness of vaginal micronized~     progesterone in prolonging pregnancy after an episode of preterm labor which responded to~     tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of~     actions of progesterone supplementation by examining its effect on the two components of~     parturition: cervical ripening and myometrial contractility. The investigators will utilize~     transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive~     trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will~     also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO),~     though EMG is expected to provide much more information.~   "
117083|NCT01523470|"~     The investigators design a pilot randomised, single-centred, controlled trial to compare~     different withdrawal methods of Non-invasive ventilation. Our study aims at comparing~     stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive~     ventilation. The primary endpoint is to compare the rate of success between two withdrawal~     methods. The investigators define success as no recurrence of acute hypercapnic respiratory~     failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped. The~     secondary endpoints include time to recurrence of acute hypercapnic respiratory failure~     measured from the time of randomisation, the total days of Non-invasive ventilation use and~     the days of hospitalisation. Results from this trial will inform design of future randomised~     trial in this area.~   "
117084|NCT01523457|"~     The primary objective of this study is to determine the progression free survival in~     patients with metastatic pancreatic cancer and in patients with locally advanced~     unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of~     folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints~     include: determine objective response rate according to RECIST; determine overall survival;~     evaluate toxicity; determine rate of resection in locally advanced unresectable stratum;~     correlate time to progression, objective response, and overall survival with early changes~     in glucose metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography~     (PET) scanning.~   "
117085|NCT01523444|"~     This proposed study tests the effectiveness and examines the implementation of screening and~     brief intervention techniques to delay initiation and reduce substance use among adolescents~     accessing medical care in Federally Qualified Health Care settings with a~     computer-facilitated intervention. The primary hypothesis is that participants in the~     intervention groups will be more likely to cease or reduce substance use at follow-up~     compared to clients in the treatment as usual condition.~   "
117086|NCT01523431|"~     The purpose of this study is to investigate the influence of dose selection of CPT-11 on~     pharmacokinetics, response and toxicity according to UGT1A1 genotype in colorectal cancer~     patients.~   "
117092|NCT01523353|"~     Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to~     the liver. This is major surgery that offers a chance of cure, but can be associated with~     complications. Fitter patients are less likely to have serious complications. We are~     interested in finding out whether a short exercise program can improve patient fitness~     before surgery and whether this can reduce surgical complications.~      We plan to measure the fitness of patients who are going to have liver surgery. We will then~     give them an exercise programme for 4 weeks, after which we will assess their fitness again.~      We are also interested in whether fitter people have better Liver function. To assess this~     we will take a small sample of liver tissue during the operation for laboratory analysis of~     its function.~      Hypothesis~        1. A short period of exercise can significantly improve fitness prior to liver surgery~        2. Greater Fitness is associated with better liver function.~   "
117093|NCT01523340|"~     1. Trial design: Prospective observational study~        2. Target population: 200 NSCLC patients with histologically or cytologically confirmed~          stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy~          who consent for study participation and meet the study selection criteria~        3. Primary objective: To investigate C-met expression/amplification and EGFR gene~          mutations in NSCLC patients treated with Erlotinib~             -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR~        4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome~          (Overall Response Rate, Progression Free survival )~        5. Duration of Trial Recruitment: 2 years~   "
117094|NCT01523327|"~     Association of maternal uric acid with maternal condition and fetal outcome in pregnant~     women with hypertension.~   "
117095|NCT01523314|"~     The research group has developed new ocular drug delivery technology based on cyclodextrin~     nanoparticles (NP). The investigators plan to develop and test this technology to help treat~     diabetic macular edema (DME).~      An important step in research was the invention of cyclodextrin nanoparticles, which has~     just received a US patent. The investigators pre-clinical and clinical work has demonstrated~     the investigators eye drop suspension with cyclodextrin nano-particles to be superior to~     conventional eye drops. They increase drug absorbance into the eye and decrease systematic~     distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops~     deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in~     ocular pharmacology.~   "
117096|NCT01523301|"~     The purpose of this study was to show superiority of Rotigotine over placebo on improvement~     of depressive symptoms in subjects with idiopathic Parkinson's disease.~   "
117097|NCT01523288|"~     The projects aim is to investigate the intestinal function of patients suffering from~     Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal~     diameter and gastrointestinal transit time~   "
117098|NCT01523275|"~     This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the~     use of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical~     treatment of patients with laryngotracheal stenosis. We hypothesize that the use of~     mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal~     stenosis.~   "
117099|NCT01523262|"~     Primary To investigate whether peripheral predonditioning induced by brief, intermittent~     constriction of blood supply to an arm can reduce the incidence of perioperative myocardial~     ischemia in patients operated electively for infrarenal aortic aneurysm.~      Secondary To investigate the impact of peripheral preconditioning on perioperative~     inflammatory response.~      To investigate whether peripheral preconditoning can protect against perioperative~     myocardial infarction and reduced cardiac pump function.~   "
117100|NCT01523249|"~     The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D~     US) technique with the traditional palpation method for identification of the needle~     insertion site on patients' skin before epidural needle placement in pregnant women. The~     investigators hypothesize that the needle puncture site identified by 3D US is located~     within a 5 mm radius from the puncture site identified by palpation.~   "
117101|NCT01523236|"~     The objective of this study is to evaluate the clinical equivalence of the test formulation~     of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva~     Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed~     formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation~     (Schering) in patients with seasonal allergic rhinitis.~      In addition, the efficacy of both the test and reference nasal sprays will be compared to a~     placebo nasal spray and safety will be compared.~   "
117102|NCT01523223|"~     This phase I trial studies the side effects and the best dose of donor CD8+ memory T-cells~     in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy~     before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. The~     donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) after the transplant may help increase this effect~   "
117112|NCT01523093|"~     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron~     8 mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy~     Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg orally disintegrating tablets of~     GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting condition.~   "
117113|NCT01523080|"~     The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended~     release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of~     Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing~     acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A in healthy,~     adult, male human subjects under fasting condition.~   "
117123|NCT01522950|"~     This is a randomized, double-blind, placebo-controlled study comparing the efficacy of~     nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular~     disease risk in subjects with early vascular disease. Approximately 75 subjects with~     borderline/elevated blood pressures and impaired endothelial function, as measured by~     arterial elasticity scores, will be recruited and assigned to treatment groups using a block~     randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo,~     and then followed for 9 months.~   "
117103|NCT01523210|"~     Intramuscular application of botulinum toxin (BoNT) is used as a successful therapy of~     muscle spasticity. Clinical practice shows, that even with the use of special guidance~     techniques to increase accuracy of targeting, BoNT may spread to adjacent sites by~     diffusion. This causes fluctuating treatment response, unintended side effects, and decrease~     of effect due to production of antibodies. Hence, clinicians require increase of efficacy~     and safety by dose reduction, improvement of injection technique, and additional treatment~     strategies. Referring to this, animal model showed increased efficacy and decreased systemic~     side effects of BoNT in the injected muscle after active or passive manipulation of muscle.~     The mechanism of this effect remain unclear.~      T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of~     fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle~     tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.~      Up to the investigators knowledge, neither a human, in vivo measurement of the influence of~     passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of~     BoNT within spastic human muscle tissue, been evaluated.~      The aim of this explorative study is:~        -  to monitor the inflow and regional distribution of the injection bolus by dynamic~          T2-weighted-, DTI-sequences;~        -  to assess the effect of passive muscle exercise on the area of denervated, caused by~          BoNT, measured by DTI-, T2-weighted and flair sequences.~      The investigators hypothesize, that~        -  intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated~          Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is~          facilitated by passive muscle exercise;~        -  primary distribution of the injected BoNT bolus can be non-invasively monitored by~          dynamic T2-, DTI- and T2 weighted sequences.~      Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper~     limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic~     Resonance Tomography) MRI of the musculus biceps brachii will be performed at two~     consecutive, routine BoNT-injection days (baseline and week 16). Patients receive dosage as~     clinically indicated, due to routine treatment. Patients will be randomised to receive~     thirty minutes of physiotherapy of the affected arm, including exercise of the elbow~     flexors, at one of the injection days (baseline, or week 16, respectively). In addition, MRI~     will be repeated 3 weeks after injection.~   "
117104|NCT01523197|"~     Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are~     two diseases that often coexist and are called overlap syndrome(OS). Compared to single~     OSAS, OS patients are more susceptible to serious hypoxia and hypercapnia especially during~     sleep, and are much more likely to result in pulmonary hypertension and cor-pulmonal.~      With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation~     may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both~     removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia~     simultaneously. The overall purpose of this study is to compare the curative effects between~     fixed BiPAP and auto-trilevel ventilations on OS patients.~   "
117105|NCT01523184|"~     This will be a single-center, randomized, parallel group, multiple dose administration,~     double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small~     bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation.~     Four groups including a placebo group will be enrolled and will receive multiple oral doses~     of YKP10811 or matching placebo.~   "
117106|NCT01523171|"~     Primary Objective:~      - To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated~     with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms,~     Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera~     myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF)~     based on the reduction of spleen volume at the end of 6 treatment cycles;~      Secondary Objectives:~        -  To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary~        -  To evaluate the durability of splenic response~        -  To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6~        -  To evaluate the splenic response to SAR302503 at the end of Cycle 3~        -  To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden~        -  To evaluate the safety and tolerability of SAR302503 in this population~        -  To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted~   "
117107|NCT01523158|"~     Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The~     majority of affected individuals manage well with medication from the Pharmacy or from their~     general practitioner (GP), but for some severely affected people it severely impacts on~     quality of life. Less than 40% of those affected in UK general practice feel that these~     medications achieve good symptomatic control.~      Specific immunotherapy or desensitisation is the practice of administering small amounts of~     allergen to allergic patients in increasing doses. This treatment is highly effective in~     these patients and furthermore is truly disease-modifying, with benefits persisting~     long-term, even when the treatment has been completed. Desensitisation is a routine~     treatment in the UK, Europe and North America. The exact immune mechanisms that underlie~     this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor~     Kern have recently developed new methods for the investigation of immune responses to~     allergens. These methods require relatively small blood samples and may provide useful~     information about how immunotherapy exerts its effects. In addition to improving the~     investigators basic understanding of this treatment, such knowledge may drive improvements~     in the treatment and could be useful for monitoring patients for response. The investigators~     study proposes to investigate changes in the immune responses to pollen allergens during~     immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again~     just prior to the final injection. In this way the investigators will be able to compare the~     immune responses to pollen allergen before and after treatment.~   "
117108|NCT01523145|"~     Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the~     western world. Atrial fibrillation can be treated with a relatively new procedure, called~     radiofrequency ablation.~      The aim of this study is to explore if patients treated with ablation for atrial~     fibrillation, benefit from an integrated rehabilitation programme, that consist of physical~     training and psycho-educative consultations with a specialised nurse.~      The hypothesis is, that integrated rehabilitation can improve mental health, physical~     capacity and other factors.~   "
117109|NCT01523132|"~     The study is a prospective cohort study following breast cancer patients from before surgery~     to one year after. The aims of the study are to determine risk factors that predispose to~     the development of persistent pain.~   "
117110|NCT01523119|"~     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron~     8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy~     Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal~     health, UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed~     condition.~   "
117111|NCT01523106|"~     This is a randomized, double-blind, placebo-controlled study, comparing the effect of~     L-carnitine vs placebo on fatigue among Crohn's disease patients.~      The specific aim of this study is to determine if treatment with L-carnitine is more~     effective than placebo at decreasing fatigue severity scores, while accounting for disease~     activity and concomitant anemia, depression/anxiety and poor sleep quality.~   "
117114|NCT01523067|"~     The primary objective of the study is to evaluate the safety and tolerability of single~     ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with~     Stage 1 or Stage 2 essential hypertension.~      The secondary objectives of the study are to characterize the pharmacokinetic profile of~     single ascending doses of Vasomera and the relationship between serum concentrations of~     Vasomera and change in systolic and diastolic blood pressure as measured by:~        -  Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by~          ambulatory blood pressure monitoring (ABPM) as compared to placebo.~        -  Identification of the minimum and maximum decrease in systolic and diastolic blood~          pressure as measured by ABPM.~        -  Mean change from baseline in cuff systolic and diastolic blood pressure as compared to~          placebo.~        -  Effect of Vasomera on pulse pressure and heart rate.~      An additional secondary objective of this study will be to characterize the immunogenicity~     profile of Vasomera following a single subcutaneous dose.~   "
117115|NCT01523054|"~     The objective of the study was to compare treatment with two different oral formulations of~     metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in~     patients with acute myocardial infarction regarding the following:~      Pharmacokinetics, peak and trough plasma concentrations and area under the plasma~     concentration curve.~      Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open,~     randomised design with two parallel groups was employed.~   "
117116|NCT01523041|"~     This trial is conducted in Europe. The aim of this trial is to compare two formulations of~     biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart~     50 and biphasic insulin aspart 70 in healthy male subjects.~   "
117117|NCT01523028|"~     Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more~     important, hence underlying the importance of better understanding the fate of these~     potential health promoting antioxidants. However, some analytical barriers as well as some~     key aspects of metabolism still remain to be fully elucidated to get the full picture of~     coffee metabolism and bioavailability. One aspect addressed in the present study is the~     impact of food matrix in modulating absorption, plasma appearance and urinary excretion of~     coffee bioactives.~   "
117118|NCT01523015|"~     The high cancer related mortality has remained a significant issue of health care in Poland,~     Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and~     a marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction~     and esophagus has been observed in the developed countries. The most eminent drawback of~     majority commonly cited randomized trials is heterogenicity of cancer patient population.~     The epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of~     the esophago-gastric junction is the entirety different both from adenocarcinoma of the~     esophagus and adenocarcinoma of the stomach. The experience in a combined modality therapy~     for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on~     esophageal or gastric cancer, where the investigated population involved in part patients~     with carcinoma of the esophago-gastric junction. The proposed study has been designed to~     achieve the following objectives:~        -  The assessment of safety and efficacy of a combined modality therapy in homogenous~          patient population with adenocarcinoma of the esophago-gastric junction excluding~          individuals with adenocarcinoma of the esophagus or the stomach;~        -  The assessment of safety of a combined modality therapy in a form of chemo- and~          chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on~          postoperative morbidity or mortality rates;~        -  The assessment of efficacy of a combined modality therapy in a form of rate of response~          of the tumor to chemo- and chemoradiotherapy and a curative resection rate.~        -  The assessment of efficacy of a combined modality therapy in a form of cancer free~          survival and overall survival.~   "
117119|NCT01523002|"~     Pyronaridine: artesunate (Pyramax) is an antimalarial fixed-dose combination therapy which~     has been demonstrated to be well tolerated and effective treatment in patients with~     Plasmodium falciparum and vivax malaria.~      This open-label Phase I study has two parts: a drug-drug interaction part intended to~     investigate the interaction of Pyramax in the pharmacokinetics of the CYP2D6 probe~     metoprolol and a re-dosing evaluation part intended to investigate the differences on the~     changes in liver enzymes induced by Pyramax in a first and in a second treatment course and~     the effect of the redosing interval on the changes in liver enzymes induced by Pyramax in a~     first and in a second treatment course.~   "
117120|NCT01522989|"~     This study is for patients with advanced solid tumor malignancies (cancer that has spread to~     other parts of the body).~      The purpose of this study is to test the safety and effectiveness of a new combination of~     drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor~     malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called~     cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting~     this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the~     5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer~     cells, thus decreasing the tumors in the body.~      PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration for use in colorectal cancer. It is given as a~     pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and~     Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved~     for and used as chemotherapy for several cancers.~   "
117121|NCT01522976|"~     This randomized phase II/III trial studies how well azacitidine works with or without~     lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes~     or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, stopping~     them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of~     cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     azacitidine is more effective with or without lenalidomide or vorinostat in treating~     myelodysplastic syndromes or chronic myelomonocytic leukemia.~   "
117122|NCT01522963|"~     The purpose of this study is to determine the timeframe (relative to a stress task) that is~     most effective at attenuating the increase in symptoms of tobacco craving and withdrawal~     that occur when smokers are presented with stressful situations.~   "
117125|NCT01522924|"~     This study determines if there is a difference in dental students' attitudes, perceived~     barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation~     treatment, and cessation knowledge in those students receiving a tobacco cessation lecture~     along with practice sessions using standardized patients and those students receiving only a~     tobacco cessation lecture. The study determines if dental students' use of tobacco affects~     their intent to provide cessation treatment to patients, and if the time between receiving~     the lecture and participating in the practice sessions using standardized patients makes a~     difference in dental students' attitudes, perceived barriers, subjective norms. perceived~     skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.~   "
117126|NCT01522911|"~     To date there are no data suggesting substantial effects of hormonal interaction after~     percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding~     the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and~     consecutive release of the hormones may be reduced. Here, we present our experience of ANP~     and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.~   "
117127|NCT01522898|"~     Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who~     also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the~     ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an~     established treatment for heart failure patients who are in normal rhythm, called sinus~     rhythm. An important subset of heart failure patients are those with atrial fibrillation~     (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients~     with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as~     effective as in sinus rhythm, due to competition between beats generated by the CRT device~     and beats conducted from the heart's own electrical conduction system. In the current study,~     we aim to test the hypothesis that ablating the AV node, which controls electrical~     conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will~     improve survival and heart failure symptoms in CRT patients with co-existent AF. The results~     are important, because they will provide a way of passing on the benefits of CRT, such as~     improved survival, less heart failure symptoms, and better quality of life, to heart failure~     patients who also suffer from AF.~   "
117128|NCT01522885|"~     The purpose of this study is to investigate whether if KatGuide (a new developed medical~     device) improves the placing of a large bore chest tube in the pleural cavity compared to~     the conventional method.~   "
117129|NCT01522872|"~     This phase 2 study is designed to evaluate the safety and tolerability activity of TH-302~     and dexamethasone with or without bortezomib or pomalidomide in subjects with~     relapsed/refractory multiple myeloma.~   "
117130|NCT01522859|"~     The the aim of this study is to determine the benefits of Telehealth monitoring in the~     management of patients with chronic obstructive pulmonary disease.~   "
117131|NCT01522846|"~     Heparinized solution has been used for maintenance of arterial catheter during perioperative~     period. Although the infused dose of heparin is very low, the investigators examine whether~     the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM)~     analysis.~   "
117132|NCT01522833|"~     With roughly 80% of cancer patients receiving their oncology care in the community setting,~     the investigators are proposing to sample from a community-based center to evaluate the~     percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit~     from erlotinib and assess the clinical characteristics that are associated with~     erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are~     EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.~   "
117133|NCT01522820|"~     This phase I trial studies the side effects and best schedule of vaccine therapy with or~     without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing~     solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in~     different ways and stop tumor cells from growing. Vaccines made from a person's white blood~     cells mixed with tumor proteins may help the body build an effective immune response to kill~     tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause~     a stronger immune response and kill more tumor cells. It is not yet known whether vaccine~     therapy works better when given with or without sirolimus in treating solid tumors.~   "
117134|NCT01522807|"~     The purpose of the study is to evaluate the plasma drug concentrations of three formulations~     of PF-05190457 after administration of single doses to healthy volunteers.~   "
117135|NCT01522794|"~     The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on~     iron homeostasis during systemic inflammation induced by endotoxin.~      In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an~     inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa,~     with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron~     concentrations decrease.~      This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin~     and to prevent serum iron decrease in a pathophysiological model prior to studying the~     efficacy of NOX-H94 in patients with anemia of chronic disease.~   "
117136|NCT01522781|"~     The purpose of this study is to obtain a prospective database which will allow analysis of~     total knee outcomes.~   "
117137|NCT01522768|"~     The purpose of this study is to find out what effects, good or bad, the combination of~     standard chemotherapy agent paclitaxel with the investigational (experimental) drug afatinib~     that targets HER2, has on HER2-positive esophagogastric cancer that started to get bigger~     despite previous treatment with trastuzumab. The doctors will also study the tumor to~     understand why it grew while on trastuzumab treatment and to see the effects afatinib and~     paclitaxel has on the tumor.~   "
117164|NCT01522417|"~     The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a~     shortened infusion duration compared to label-dosing eptifibatide in patients undergoing~     percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of~     death, PCI-related myocardial infarction, urgent target vessel revascularization or~     in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever~     comes first.~   "
117179|NCT01522222|"~     To demonstrate that using continuous mechanical lung ventilatory support in combination with~     Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function~     and decrease lung complications after surgery.~   "
117138|NCT01522755|"~     Pacing leads are key elements of a pacing system as their proper functioning is one of the~     major factors affecting the long term performance of the whole system.~      Success of a pacing lead implant can be defined considering 3 items: ease of lead implant,~     lead stability and lead electrical performances.~      These factors may be related to the physician experience (global implant experience,~     experience with a given lead), to the implant procedure (lead access, lead position, implant~     time, scopy time) to the lead (handling and mechanical characteristics) and to the patient~     (ischemic history).~      Even though implant success rate is quite high with currently available leads, the weight of~     the different factors influencing success has never been studied systematically. The~     objective of the current study is then to define the predictive factors of an implant~     success with the CapsureFix MRI model 5086.~      This lead has been selected because it has been available for a short period, so the~     investigators have a limited experience of it and it has a unique design which makes it~     conditionally safe in an MRI environment and which may be associated with specific handling~     characteristics.~   "
117139|NCT01522742|"~     The main aims of this study are to determine whether: a) psoriasis patients with or without~     arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of~     etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by~     their treating clinicians) will decrease cardiovascular inflammation.~   "
117140|NCT01522729|"~     Recently, direct evidences point to the contributing role of peripheral muscle fatigue in~     exercise tolerance among patients with COPD. However, the physiological mechanisms by which~     peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors~     regulating peripheral muscle fatigue in COPD may be complex. One possible link between limb~     muscle fatigue and exercise intolerance could be enhanced afferent signals from the active~     limb muscles to the central command, thereby limiting central motor output and eventually~     leading to exercise termination.~      A direct method to investigate the regulation of peripheral muscle fatigue during exercise~     in patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia.~     Consequently, investigating the interplay between the peripheral muscular component and the~     central motor command during self-paced exercise could shed light on the regulation of~     peripheral muscle fatigue in COPD and its implication in exercise intolerance.~   "
117141|NCT01522716|"~     The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as~     treatment for steroid-refractory chronic graft-versus-host disease.~   "
117142|NCT01522703|"~     The primary objective of this study is to determine if broccoli sprouts (BS) improves airway~     inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen~     sensitization.~      The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo~     in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be~     randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a~     sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.~   "
117143|NCT01522690|"~     The objective of this study is to obtain normative accelerometry data during the six minute~     walk test and a 30 second walk test on healthy subjects in order to determine the~     accelerometric variables that are the most relevant to describe gait disorders in patient~     populations. Secondary objectives of this study are to investigate the impact of walking~     speed and muscle strength on the accelerometric parameters, to assess the reproducibility of~     the method and to compare accelerometric data obtained with two different devices.~   "
117144|NCT01522677|"~     The central hypothesis for this study is that it is safe and feasible to administer~     intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized~     inflammatory/immune response. The objective is to demonstrate the feasibility and safety of~     PDT to colon cancer patients administered before surgery and to characterize the~     inflammatory/immune response at the tumor site and systemically. The long-term objective of~     these studies is to modify he natural biology of colorectal cancers and improve patient~     survival.~   "
117145|NCT01522664|"~     This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A~     in patients with metastatic or unresectable melanoma. Cohorts of patients will receive~     escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the~     absence of disease progression or unacceptable toxicity, patients may continue to receive~     DEDN6552A for up to 17 cycles (1 year).~   "
117146|NCT01522651|"~     The purpose of this study is to evaluate whether treatment with ranolazine or low dose~     dronedarone reduces atrial fibrillation burden (AFB) in subjects with paroxysmal atrial~     fibrillation (PAF), and whether combination therapy (ranolazine and low dose dronedarone) is~     superior to individual drug therapy in reducing AFB.~      This phase 2 clinical trial will be conducted over 16 weeks and involves a Screening period~     (4 weeks) and a Treatment period (12 weeks). The final follow up visit will occur 2 weeks~     after the end of the Treatment period. Primary and Secondary endpoints will be evaluated~     according to treatment group, clinic visit period, and the overall Treatment period. Safety~     analyses will be conducted at each clinic visit, and include: cardiac rhythm monitoring, ECG~     testing, laboratory evaluation, and symptom and adverse event assessment.~   "
117147|NCT01522638|"~     The purpose of this study is to determine the anatomy of the retina and the optic nerve in~     patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of~     the study is to determine why patients with the same type of genetic material, i.e. the same~     mutation, have such large variations of symptoms, spanning from unaffected subjects to~     blindness. The project requires examination of both healthy and affected family members.~   "
117148|NCT01522625|"~     This study aims to clarify whether patients with chronic hepatitis B with high viral load~     will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.~   "
117149|NCT01522612|"~     OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of~     cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced~     colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil~     alone.~   "
117150|NCT01522599|"~     The main objective of this randomized multicenter clinical trial is to test the hypothesis~     that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as~     compared to the conventional ARDS-Net ventilation. Control of PaCO2 in the ~4 ml/kg arm~     would be accomplished by LFPPV- ECCO2-R.~   "
117152|NCT01522573|"~     The purpose of this registry is to record information and evaluate the impact of Endoscopic~     Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the~     management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and~     technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde~     cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided~     ERCP procedures have been assessed in a series of studies.~      This multi-center registry has been initiated:~        -  To document the impact of EUS-Guided ERCP procedures on the management of~          pancreatico-biliary disorders including malignancies.~        -  To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic~          or therapeutic procedures.~      Design is retrospective and prospective registry study.~      Procedures that will be captured include:~        1. EUS-Coils placement~        2. EUS Glue injection~        3. EUS-Fiducial placement~        4. EUS-Neurolysis~        5. EUS-Stent placement~        6. EUS-alcohol injection~        7. EUS-fluid collection, abscess or cavity drainage~        8. EUS guided ductal drainage~        9. EUS-guided Ablation~       10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary~          duct drainage~   "
117153|NCT01522560|"~     Professionalism is one of the six competences required by The Accreditation for Graduate~     Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia~     residents are faced with unique communication challenges in their practice including brief~     contact time with their patients, operating room efficiency pressure, etc. To assess~     professionalism in Anesthesiology residents is important to obtain evaluations from people~     with whom they interact including patients, surgeons, colleagues and members of the support~     team. The Multisource feedback (MSF) approach has been used to evaluate communication skills~     and professionalism among practicing physicians and residents in a variety of settings. This~     evaluation model has never been used previously to evaluate anesthesia residents. The~     investigators propose a randomized controlled trial to validate and evaluate a MSF in~     professionalism for anesthesia residents. Participants include eighty residents doing two~     months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia~     Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using~     face and content validity methods and comparing them with the current system of evaluation.~     Residents will be randomly assigned to a feedback group or to the control group. Both groups~     will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group~     assigned to feedback is going to have a 'coaching meeting' every month to identify strengths~     and weaknesses and create strategies for improvement. The investigators are planning to~     compare the mean values of the baseline evaluations with the mean values obtained after the~     first and second months from the MSF.~   "
117154|NCT01522547|"~     The purpose of the study is to determine the maximum tolerated dose, safety and effect on~     induction of fetal hemoglobin of pomalidomide in patients with Sickle Cell Disease.~   "
117155|NCT01522534|"~     The purpose of the study is to determine the efficacity of a simple blind technic of loco~     regional anaesthesia of the sciatic nerve compared to the gold standard in emergency~     medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma~     in the prehospital setting and mountain rescue.~   "
117156|NCT01522521|"~     The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese~     patients with primary osteoporosis.~   "
117157|NCT01522508|"~     The aim of this prospective randomized study was to evaluate the ability of the new~     Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful~     stimulation during either propofol or sevoflurane anesthesia and changing remifentanil~     concentrations.~   "
117158|NCT01522495|"~     Little is known about chronic wound microenvironments, especially in peripheral vascular~     disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells~     and tissue is unclear. A means to determine cell viability, particularly discerning an~     apoptotic or necrotic cell pathway would indicate where the line of demarcation should be~     drawn. The information generated would better predict clinical outcome using SPY Imaging.~     Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate~     surgeon subjectivity.~   "
117159|NCT01522482|"~     Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK.~     Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying~     particles), in particular low density lipoproteins (LDL) in circulation, is one of the most~     important physiological defects contributing to the development of CVD.~      The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE~     genotype, with E4 individuals (25% of the UK population) being most responsive to changes in~     dietary fats, showing greater reductions when low levels of saturated fats or fish oils are~     consumed and greater increases when high levels of these fats are consumed. Therefore the~     aims of the present study is to understand the mechanism that regulates the higher LDLC~     response associated with saturated fatty acids and fish oil consumption in healthy men~     prospectively recruited based on their APOE genotype.~   "
117160|NCT01522469|"~     This is a Phase II open label study of crenolanib besylate. This study will enroll subjects~     with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other~     FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses~     daily (preferably every eight hours), taken orally at least 30 minutes pre or post meal~     until disease progression, death, or the patient discontinues treatment for adverse events,~     investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic~     stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt~     to maintain remission.~   "
117161|NCT01522456|"~     To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to~     Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3~     weeks in terms of local tolerability parameters (erythema, dryness, scaling,~     stinging/burning) and preference.~   "
117162|NCT01522443|"~     Bone metastases and associated pain are a major cause of morbidity and mortality in~     castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability~     to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated~     by lack of resolution of lesions on bone scan with these agents) or the pain associated with~     these metastases.~      This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on~     pain response and bone scan response in men with CRPC.~   "
117165|NCT01522404|"~     The purpose of this study is to find out if atomoxetine causes a change in the biologic~     markers (substances that may indicate the presence of a disease) in the cerebrospinal fluid~     (CSF) of participants diagnosed with Mild Cognitive Impairment (MCI). In this research~     study, the spinal fluid of subjects with MCI who take atomoxetine will be compared to spinal~     fluid of those who take capsules containing inactive material, also known as placebo. At the~     six-month timepoint, subjects who were taking placebo during the first six months will be~     placed on active study medication, and those who received active study medication will be~     reassigned to placebo. After completion of the study, subjects will be able to receive~     open-label atomoxetine.~      This study will also evaluate if the drug is safe and well-tolerated. Additionally,~     information will be gathered to identify the dose of atomoxetine that is most beneficial,~     and how taking this medication affects thinking and behavior, as well as imaging and blood~     biomarkers. The results of this research will help determine if atomoxetine alters signs of~     inflammation and other biomarkers associated with Alzheimer's disease.~   "
117166|NCT01522391|"~     The primary objective of this study was to evaluate microbial density in eczematous lesions~     during two weeks of twice daily therapy with the investigational product, DPK-060 1%~     ointment, compared with placebo in patients with atopic dermatitis. This randomized,~     double-blind, placebo-controlled part of the study was preceded with an open-label~     investigation in a small group of patients (n=5) treated with two applications of DPK-060 1%~     ointment per day for four days to assess safety, local tolerability and systemic absorption~     of DPK-060.~      The secondary objectives were to evaluate severity of eczema and pruritus, to assess the~     tolerability and safety of the treatment and to assess the degree of systemic absorption of~     DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.~   "
117167|NCT01522378|"~     Congestive heart failure (CHF) affects nearly 5 million Americans and claims more than~     300,000 lives annually. A primary pathophysiologic mechanism in this deadly syndrome is an~     abnormally enhanced sympathetic nervous system that results in profound peripheral~     vasoconstriction, attenuated cardiovascular reflexes, higher susceptibility to ventricular~     arrhythmias, and sudden cardiac death. The reduction in mortality and morbidity in CHF by~     pharmacologic neurohumoral antagonists such as beta-receptor inhibitor and angiotensin~     II-converting enzyme (ACE) inhibitor has taught us that regulation of the impaired~     neurohumoral axis is important for improving clinical outcome. In addition, an emerging~     nonpharmacologic approach, cardiac resynchronization therapy (CRT), has shown promise for~     improving symptoms and quality of life in patients with New York Heart Association (NYHA)~     functional class III or IV and intraventricular conduction delay. However, despite~     significant advances in CHF treatment in the past two decades, a gap remains between~     clinical outcome and the mechanisms of the protective effects of these modern therapies.~      CHF is associated with increased concentrations of circulating norepinephrine (NE),~     down-regulation of adrenergic nerve terminals, and abnormal NE reuptake. The suppression of~     cardiac sympathetic nerve endings could be reversed by CRT, a novel anti-heart failure~     therapy, by rebalance cardiac sympathetic activity, and improve cardiac function in patients~     with heart failure.~   "
117168|NCT01522365|"~     This study has been designed in order to collect data with regards to the peri-implant~     tissue outcome of abutment-supported restoration and direct implant-fixed restoration.~     Therefore a small group of subjects with partly edentulous maxilla is selected to show that~     both techniques are efficient and safe and to show comparable peri-implant tissue outcome~     for both methods. At the time of impression forming for each centre treatment A (=~     abutment-supported XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE®~     CAD/CAM supra-structure) is assigned to the left and right side of the maxilla by being~     randomized at the time of impression forming.~   "
117169|NCT01522352|"~     This study suggests for the first time a comparison of the hemodynamic performance of the~     two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis~     available since September 2010 at the University Hospital of Clermont Ferrand.~   "
117170|NCT01522339|"~     The purpose of this study is to determine the safety of a customized MRI scanner and gather~     preliminary data on image quality in a group of 10 medically stable infants admitted to the~     Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center~     (CCHMC).~   "
117171|NCT01522326|"~     The objective of this study is to determine the efficacy of metoclopramide in relieving the~     symptoms of Acute Mountain Sickness (AMS).~      It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide~     (which has been study-proven to be effective in relieving symptoms of migraine headache)~     will prove to be more efficacious in relieving symptoms of acute mountain sickness than the~     standard, previously-studied analgesic medication, ibuprofen.~   "
117172|NCT01522313|"~     This study investigates the influence of perioperative changes in serum creatinine on~     hospital length of stay and mortality.~   "
117173|NCT01522300|"~     The main objective of the study is to assess the sensitivity and specificity of~     Tomosynthesis in detecting the multicentricity of mammary tumor.~   "
117174|NCT01522287|"~     The goal of this project is to improve access to effective treatments for obsessive~     compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT)~     treatment. There intervention involves both a computer program (BT Steps) and human~     interaction via telephone. The investigators will test the efficacy and feasibility of~     computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus~     a CBT therapist coach (n=35~   "
117175|NCT01522274|"~     This research study is for FEMALE cigarette smokers who want to quit smoking.~      Participants will be provided with brief quit-smoking education at the beginning of the~     study and will receive the nicotine patch for 10 weeks, free of charge.~      Participants will be assigned to either an exercise program or a general health education~     program. The exercise and health education programs will take place over 14 weeks, with~     follow-up appointments 3, 6, and 12 months after the end of the 14-week program.~      There is no fee for any part of this study and participants will be compensated for their~     time.~   "
117176|NCT01522261|"~     Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with~     visualization of the operative field during laparoscopic pelvic reconstructive surgery?~   "
117180|NCT01522209|"~     The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with~     the new method of intraoperative contrast enhanced ultrasound to compare all methods for~     their rate of detection of colorectal liver metastasis.~   "
117183|NCT01522170|"~     There is growing but limited information on the long term clinical status of aHUS patients~     who have previously received or are continuing to receive treatment with eculizumab. This~     study is designed to collect clinical data that will provide insight into the long-term~     outcomes of patients with aHUS.~   "
117184|NCT01522157|"~     The trial will study the acute metabolic effects of three different types of diet: low-fat~     diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus~     type 2 will be recruited and each of them will be given each type of diet on three different~     days. Menus with the same energy content but with different content of fat, carbohydrate and~     protein are designed. Breakfast and lunch are served for the patients each day of testing.~     Laboratory samplings are performed six times during the day. The order of the dietary~     intervention is randomized for each patient.~      The investigators suppose to find different reaction in plasma glucose and lipids depending~     on the type of diet.~   "
117185|NCT01522144|"~     The Children's Hospital of Philadelphia's ambulatory network uses an electronic health~     record (EHR) to document clinical information. Using the EHR, a clinical decision support~     tool will be designed to help the primary care physician's in caring for children with~     asthma. The goal will be to improve the primary care physician's use of the national~     Institutes of Health guidelines for the best care for asthma. To study this EHR decision~     support tool, it will be introduced into 5 practices while 5 other practices will have the~     existing asthma care information. It will be determined whether the physicians in the~     practices with the decision support tool are better at following the asthma guidelines. If~     the decision support tool works...then it will be offered to others to use with their EHR~     systems.~   "
117186|NCT01522131|"~     Purpose: The proposed study will evaluate and compare the clinical response of using~     bioresorbable collagen membrane alone or defect debridement with erbium Laser irradiation in~     conjunction with bioresorbable collagen membrane in the treatment of Class II furcation~     defects in maxillary and mandibular teeth. The study will examine whether there is a~     superior regeneration potential when the laser energy is combined with membrane defect~     isolation.~      Procedure: The study will use 2 groups, a control group and a test group with 16 patients in~     each group, with severe chronic periodontitis having clinical or radiographic evidence of~     Class II furcation defects in the buccal or lingual of the mandibular molars or Class II~     furcation defects on the buccal of maxillary molars. 16 patients will serve as the control~     group and open flap debridement with bioresorbable collagen membrane will be the mode of~     treatment. Group 2: 16 patients will serve as the test group and will undergo open flap~     debridement in conjunction with Er, Cr: YSGG laser irradiation and a bioresorbable collagen~     membrane will be used.~   "
117187|NCT01522118|"~     Since prostate specific antigen (PSA) was introduced as a clinical screening tool for~     prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced~     disease. The present choice of treatment for men with localized prostate cancer lies between~     active surveillance and radical therapy. Thus, the option of treating only the cancer within~     the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very~     controversial. At present there are no consistent scientific data on focal therapy and its~     major effectiveness.~      Focal therapy for prostate cancer is defined as therapy that selectively ablates known~     disease while preserving existing functions, with the overall aim of minimizing lifetime~     morbidity without compromising life expectancy.~      The aim of the investigators study is to test if Magnetic Resonance guided Focused~     Ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced~     prostate cancer.~      The study i designed as Phase 1, treatment & resection protocol. With this project the~     investigators further aim to evaluate the safety and identify side effects of Magnetic~     Resonance guided Focused Ultrasound in treating focal prostate cancer.~      This design will also expand knowledge of the effect of Magnetic Resonance guided Focused~     Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted~     after this non-invasive treatment.~   "
117188|NCT01522105|"~     5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose~     of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin~     administration a second lumbar puncture is performed to determine the peak concentration of~     daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will~     be measured in the plasma. The investigators anticipate that daptomycin penetrates into the~     cerebrospinal fluid in bactericidal concentrations~   "
117189|NCT01522092|"~     Anxiety and depression are common in patients with severe chronic obstructive pulmonary~     disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear~     and indeed this may be the main cause for the for hospital admission. Patients prone to a~     tendency to experience and communicate somatic distress in response to psychosocial stress~     and to seek medical help for it are top of the frequent flyer league, costing the health~     care economy dearly. This is a particular problem in Hull with the high levels of smoking~     and urban deprivation combining to place the city at the bottom of the Department of Health~     COPD league tables.~      Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes~     of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus~     allowing the patient time to access the existing community based support services.~   "
117190|NCT01522079|"~     Respiratory dysfunction is the major cause of morbidity and mortality in patients with~     spinal muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used~     but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not~     clear.~      Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic~     function in patients with spinal muscular atrophy types II and III.~      Methods: Patients with spinal muscle atrophy type II and III will be recruited.~     Electrocardiogram signals will be recorded for analyses of heart rate variability during air~     stacking in supine and sitting position.~   "
117211|NCT01521806|"~     This study will examine the effects of a dietary fiber on insulin sensitivity in overweight~     and obese women. The fiber will be added to snack foods and women will consume the foods for~     four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in~     another period. In a third period, no fiber will be added to the snack foods. Insulin~     senstivity will be measured at the end of each treatment period.~   "
117485|NCT01518218|"~     The objective of this study is to evaluate the effectiveness of 1-year administration of~     laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in~     Africa.~   "
117191|NCT01522066|"~     An alternative to general anesthesia - which puts a patient completely to sleep - is~     regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block'~     a nerve or set of nerves. This method allows a patient to be awake during surgery and avoids~     any unpleasant after-effects of general anesthetic. A regional block is normally performed~     by inserting a needle under the skin so that the needle tip is near the nerve to be blocked,~     followed by injection of a single shot of enough local anesthetic to block any sensation~     that the nerve normally provides. Although regional nerve blocks provide pain relief during~     a surgical procedure, they eventually wear off, occasionally leaving the patient to contend~     with localized pain in the part of the body that was operated on. In these cases,~     over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely~     take away the pain. We believe that, instead of giving a single shot of anesthetic, patients~     can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose~     of local anesthetic to block the nerve before surgery and which could also be used to~     deliver a second dose of anesthetic just prior to discharge from the hospital. This way, the~     patient still only receives one needle poke, but their pain can be better managed following~     surgery. Our study will compare the post-nerve block pain profiles of individuals who have~     received a single-shot injection of local anesthetic versus those who have received two~     doses via the catheter delivery method.~   "
117192|NCT01522053|"~     When anesthesiologists perform a regional nerve block, they will often put a catheter - a~     flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic.~     This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and~     after surgery. The most common method of placing the catheter close to a nerve involves~     threading the catheter through a needle which has been inserted under the skin. Because the~     catheter is very thin and flexible, it does not thread well through tissue and will buckle~     and kink when enough force is applied to it. Another problem is that the puncture hole left~     by the needle is larger than the diameter of the catheter, meaning that when the needle is~     withdrawn, the catheter is not secure, which increases the chance that it will dislodge and~     cause leakage of local anesthetic. One solution to these problems is to use a catheter~     placement method similar to how intravenous catheters are installed. In this method, the~     catheter fits around ('over') the needle, which results in more support for the catheter~     while it is being pushed under the skin. We wish to examine if a catheter-over-needle method~     would be useful for placing a catheter to deliver local anesthetic during peripheral nerve~     blockade. We will compare the catheter-over-needle method to the currently used~     catheter-through-needle method on patients who require continuous anesthetic delivery for~     their surgery; half the patients will receive anesthetic through one method, and the other~     half will receive anesthetic through the other method. We believe that using the~     catheter-over-needle method will result in more secure placement of the catheter and more~     efficient delivery of local anesthetic.~   "
117193|NCT01522040|"~     This is a prospective randomized pilot study that seeks to address the research question: In~     children with moderate-to-severe asthma, do intravenous magnesium infusions added to~     standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time~     from patient presentation until PICU discharge?~   "
117194|NCT01522027|"~     Critically ill patients or patients under prolonged unconsciousness need a tube inserted~     into their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be~     connected to a ventilation device to allow the patient to breathe when they cannot do it for~     themselves. In the hospital, doctors will perform a percutaneous tracheostomy (PT), where a~     needle is inserted through the skin of the neck into the windpipe, providing a guide for a~     tube that will dilate the tissue and create a hole that the tracheostomy tube can be~     inserted into. Although this is a common procedure in critical care units, it does carry~     some risks to the patient and is not always successful. The needle may puncture the back or~     side of the windpipe if it is inserted too far, or it can miss the windpipe altogether,~     causing damage to surrounding structures. We believe that doctors who perform PT would~     benefit from a method that improves the success rate of the procedure. We wish to test a~     device that alerts the doctor performing PT to when the needle tip is in the air-filled~     windpipe. The device has been proven to aid needle insertion in cadavers, but it needs to be~     tested on live patients. Since many intensive care patients undergo PT, we wish to test our~     technique on this population. It will be a controlled environment and the clinicians are~     experienced in PT. This technique should save valuable time, result in more accurate needle~     insertion, and lessen the risk of damaging other structures and tissues in the neck.~   "
117195|NCT01522014|"~     Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the~     geriatric population. Numerous studies have reported good mid and long term results of THA~     in patients over the age of 60 years. With the reported high success rate of this surgical~     intervention, the THA surgery is being performed in younger patients who have significant~     joint disease.~      A clinical trial, using a randomized blinded design, was undertaken to compare the~     functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire~     polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis~     of the hip.~      Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year~     follow-up is currently underway.~      The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the~     RAND-12, as well as measurement of complication and revision rates. The patient's demand on~     the implant as calculated by the patient's age, weight, health status and activity level was~     also measured.~   "
117212|NCT01521793|"~     The purpose of this study is:~        -  To evaluate the safety of up to 3 additional courses of oral QLT091001 administered~          once daily for 7 days in subjects treated previously with a single 7-day course of~          QLT091001 in Study RET IRD 01~        -  To evaluate whether up to 3 additional courses of oral QLT091001 administered once~          daily for 7 days can maintain or improve visual function.~   "
117213|NCT01521780|"~     The purpose of this study is to characterize the baseline variability of a panel of tissue~     (tumor and adjacent) and blood-based biomarkers obtained from participants with~     hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80%~     Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one~     core needle biopsy (CNB) equivalent is =< 0.65.~   "
117196|NCT01522001|"~     Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people~     suffering from Heart Disease. It involves;~        -  Dietary counseling,~        -  Exercise training,~        -  Psychosocial support,~        -  Physician~        -  smoking cessation~        -  Patient education~      The purpose is quick and complete recovery and to reduce the chance of recurrence.~      In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital~     based cardiac rehabilitation at discharge.~      The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the~     Regions, who runs the hospitals, to the municipalities.~      Shared care is in this setting that elements of treatment are completed different places in~     Health Care.~      The aim of this study is:~        -  to establish a shared care model for Cardiac rehabilitation following admission with~          Acute Coronary Syndrome and~        -  to compare this model to the existing hospital based cardiac rehabilitation after~          admission with Acute Coronary Syndrome.~      Primary outcome is participation in cardiac rehabilitation.~   "
117197|NCT01521988|"~     - Background:~      Atrial fibrillation is frequently associated with typical atrial flutter in clinical~     practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved~     in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation~     that occurs in about 70% of these patients after several years of follow-up. However, the~     latter arrhythmia is associated with significant morbidity and mortality. The problem of~     atrial fibrillation occurrence after successful ablation of typical atrial flutter remains~     physicians primary concern in monitoring these patients.~        -  Objectives:~      The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon~     cryotherapy technology performed at the time of flutter ablation, significantly reduces the~     risk of developing atrial fibrillation in the two year period following the procedure.~        -  Selection Criteria:~      Patients referred for ablation of typical atrial flutter with an history of at least one~     documented episode of atrial fibrillation (atrial flutter remaining the predominant~     arrhythmia)will be enrolled in the study.~        -  Study Methods:~      This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial~     fibrillation occurrence over a two years period following either an ablation procedure of~     typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation~     and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18~     months.~      Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then~     be regularly followed up clinically and by long-term ECG recordings.~        -  Evaluation Criteria:~      The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial~     fibrillation, documented by an ECG or an R-test, occurring between M3 and M24~        -  Number of patients:~           170 patients will be enrolled in the study~        -  Number of centers:~      Four French and three German centers will participate.~        -  Perspective:~      The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in~     the patient group with pulmonary vein isolation, could lead to a modification of atrial~     arrhythmia treatment indication.~   "
117198|NCT01521975|"~     Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an~     individualized telbivudine treatment roadmap strategy designed to achieve optimal viral~     suppression and low resistance rate in patients with chronic hepatitis B(CHB), which~     includes adding ADV treatment at different time points according to individual patient~     response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm~     LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve~     patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total~     CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log~     showed a good 2 year efficacy, but we still look forward to more efficient treatment and~     lower resistance rate. This study complies with the principle of individualized therapy~     recommended and ethical principles. It is expected that this study design with~     individualized treatment approach may improve efficacy and lower the resistance rates. In~     addition, it will provide important information on how to bring greater benefits to patients~     with CHB.~   "
117199|NCT01521962|"~     To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in~     patients with diabetes when used in combination with insulin.~   "
117200|NCT01521949|"~     Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long~     doubling times do not require immediate treatment with androgen deprivation therapy and may~     be safely observed. In these situations where current treatment options may cause more~     unnecessary side effects than anticipated benefit, it is reasonable to use a low-risk~     natural product such as Acai Juice Product with antioxidant properties to evaluate whether~     there are any anti-cancer effects.~   "
117201|NCT01521936|"~     This partially randomized phase II trial studies the side effects and best way to give and~     best dose of cholecalciferol in treating patients with acute myeloid leukemia (AML)~     undergoing intensive induction chemotherapy. Cholecalciferol may help improve the outcome of~     patients with AML undergoing intensive chemotherapy~   "
117202|NCT01521923|"~     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in~     combination with Methotrexate (MTX) for sustaining clinical response achieved in study~     RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved~     sustained Low Disease Activity at Week 52 in study RA0055 Period 1.~   "
117203|NCT01521910|"~     The purpose of the investigators study was to determine the effect of dietary protein~     restriction on survival and progression to end stage renal disease (ESRD) in diabetic~     nephropathy.~   "
117204|NCT01521897|"~     This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3)~     factors affecting safety in terms of the safety in infants starting to receive Prevenar at~     the age of more than 2 and less than 7 months in routine medical practice.~      This surveillance will specifically focus on the occurrence of the following:~        1. Local reactions at the injection site~        2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)~   "
117205|NCT01521884|"~     People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.~     In this study we are measuring the impact of SC biologics on these parameters.~   "
117206|NCT01521871|"~     By means of a prospective, randomised trial the investigators want to examine skin closure~     in living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue~     (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1;~     30 + 30 donors).~      Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least~     as good as conventional suture regarding wound healing/complications. (ii) Peroperatively,~     tissue glue is faster than conventional suture.~   "
117207|NCT01521858|"~     Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial~     blood loss. The investigators will investigate the relationship between the various~     hematologic variables and postoperative bleeding volume.~   "
117208|NCT01521845|"~     The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac~     necrosis(CKMB and troponin I) and inflammation marker CRP.~   "
117209|NCT01521832|"~     This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics~     of single and multiple escalating doses of SEN0014196.~   "
117215|NCT01521754|"~     The purpose of this observational registry is to evaluate the long-term effectiveness,~     safety and performance of market-released Medtronic Neuromodulation products for Deep Brain~     Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource~     use and patient reported outcomes, such as health related quality of life will be assessed.~   "
117216|NCT01521741|"~     The objective of this study is to determine the level of symptoms, functional disability,~     and changes in quality of life that breast cancer patients experience from changes in their~     arm(s) during and after treatment for breast cancer. These problems are often associated~     with transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered~     ability to use the arm for functional activities of daily living. The goal of this study is~     to collect data to support the hypothesis that swelling and other impairments in the upper~     extremities, causes a significant level of symptoms, functional disability and diminished~     quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in~     the upper extremity (such as decreased functionality, sensory changes, pain or stiffness)~     are related to early, low volume lymphedema.~   "
117217|NCT01521728|"~     The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis~     (ALS) often include: Does exercise help slow the progression of the disease?, Is there~     any harm in exercising?, or What type of exercise (endurance or resistance) is most~     appropriate? At this time, however, there is a lack of answers for people who suffer from~     an illness that affects their strength above all else. Yet the beneficial effects of~     exercise in both healthy people as well as people with other diseases have been extensively~     studied and resulted in recommendations about the types of exercise that are beneficial. In~     this study the investigators will ask participants with ALS to exercise in one of three~     ways: weightlifting (resistance exercise), stationary bicycling (endurance exercise), and~     range of motion exercise (the current standard of care for ALS patients). The~     investigators will use several different types of tests to determine whether one type of~     exercise is tolerated better and is safer than another. The investigators will also collect~     information about how the body responds to exercise in ALS. This study will help in the~     development of a larger national study to understand how exercise can be combined with other~     treatments to potentially improve strength and alter the course of the disease.~   "
117218|NCT01521715|"~     Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial~     Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable,~     intermediate and poor. To our knowledge there is only one study which examined the poor risk~     group (Hudes et al.), which led to the approval of temsirolimus in this population. However~     temsirolimus demonstrated a low response rate of 8.6% according to Response Evaluation~     Criteria In Solid Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5~     months and not all patients are suitable for temsirolimus treatment.~      Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase~     Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a~     mTKI-treatment in high-risk patients has not been conducted.~      Pazopanib was recently approved for the first-line treatment of advanced renal cell~     carcinoma in Europe and the USA. In the pivotal Phase III trial only nine patients in the~     pazopanib group were poor risk according to MSKCC risk criteria and no analysis of this~     subgroup was performed. Therefore further data in this group of patients with high medical~     need is needed.~      Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI~     treatment. This is one of the most important scientific questions in this field. In addition~     to the clinical endpoints in this study, the comprehensive biomarker program seeks to~     evaluate biomarker candidates and will help to learn more about the effects of pazopanib on~     the human organism.~   "
117219|NCT01521702|"~     The aim of this study is to test the additional value of neoadjuvant chemotherapy to the~     standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).~      This study will be performed in compliance with the study protocol, GCP (good clinical~     practice) and the applicable regulatory requirements.~   "
117220|NCT01521689|"~     Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances~     have established correlation between the quality of the response (in particular achievement~     of negativity of minimal residual disease (MRD) and progression free and overall survival.~     That is why MRD negative complete remission (CR) is the current goal in CLL treatment.~      The association of Rituximab fludarabine cyclophosphamide leads to the best response rate~     with 52 to 72% CR in medically fit untreated CLL patients. MRD results in this setting are~     still preliminary and around 50%. However many other situations (unfit, elderly, relapse,~     haematological toxicity leading to early interruption of treatment…) are associated with~     much lower response rate that would be improved by consolidation treatment.~      Monoclonal antibodies are the treatment of choice for consolidation because of sparing~     marrow and targeting CLL cells. Alemtuzumab has been used for this purpose and results~     confirm improvement of CR and MRD negative responses but alemtuzumab induced~     immunodeficiency lead to unacceptable infectious complications. Rituximab monotherapy~     induces low response rate at standard dose regimen. This is at least partially due to~     shaving of CD20, mechanism by which CD20 is lost from the leukemic cells but these cells are~     not cleared. Using low doses of rituximab reduced shaving and allowed CLL cells clearance by~     the mononuclear phagocytic system. Such low doses of rituximab can be administered~     subcutaneously.~      The investigators then propose subcutaneous low dose rituximab in consolidation to CLL~     patients responding after induction but having not achieved MRD negative CR.~   "
117221|NCT01521676|"~     Research of predictive clinical and biological factors in breast cancer :~      genomic, proteomic, mutation~   "
117222|NCT01521663|"~     The purpose of this study is to determine whether IPX159 is safe and effective in treating~     symptoms of RLS in subjects with Restless Legs Syndrome.~   "
117246|NCT01521351|"~     A prospective study of 700 patients with coronary artery disease will undergo non invasive~     evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients~     will be followed up for 3 years and their outcome regarding the cardiovascular events~     (death, cardiac events, cerebrovascular events) will be recorded~   "
117247|NCT01521338|"~     The goal of this research study is to collect blood and urine samples from people who have~     either the R117H type of CF or the non-G551D gating type of CF to be kept for future~     research.We will also use some of the collected blood to measure the number of neutrophils.~   "
117223|NCT01521650|"~     Longer surgical procedures require intubation and there is a potential risk of contaminating~     the lower airways with pathogenic bacteria from the mouth and oropharynx.~      Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal~     but those do occur among patients, both in those not so sick and patients with more severe~     problems.~      For ICU patients we have seen a reduction of emerging enteric bacteria in patients given~     oral care with probiotics and this is a pilot study to explore the possibility of the same~     kind of positive effects in patients due for longer (more than 4 hours of anesthesia)~     procedures.~      Randomisation~        -  No prophylaxis~        -  Preparation with a probiotic suspension before intubation.~      Cultures~        -  oropharynx~             -  before treatment~             -  after intubation~             -  before extubation~             -  day 1 postoperatively~        -  tracheal secretions~             -  after intubation~             -  before extubation~   "
117224|NCT01521637|"~     Subjects who are hospitalized in the ICU will be included after 24 hours of intubation~     during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be~     performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators~     hypothesize an attenuated loss in muscle fiber size.~   "
117225|NCT01521624|"~     Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic~     hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes~     of this process. Despite the critical role of oxidative stress in diabetes, most clinical~     trials with available antioxidants and vitamins have either failed to show any long term~     benefits or have produced inconsistent results (10-11). There has been growing interest in~     establishing the possible roles of oral hypoglycemic agents including Metformin in reduction~     of oxidative stress. Metformin, the most common prescribed oral medication in type 2~     diabetes, lowers HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or~     sulfonylureas), has relatively few contraindications, its adverse effects are generally~     tolerable, does not cause weight gain, is cheap, and is highly acceptable among patients.~     Given the long term benefits observed with metformin use, a role in modulating oxidative~     stress is imputable. We designed this study to evaluate the actions of metformin on~     oxidative stress in a group of medication-naïve newly diagnosed type 2 diabetes patients.~   "
117226|NCT01521611|"~     To determine whether a radiolabelled antibody that targets the bone marrow (the 'anti-CD66')~     can be administered safely to patients as part of the preparative treatment prior to~     haematopoietic stem cell transplantation ('a bone marrow transplant'). Can the radiolabelled~     antibody be shown to effectively target the bone marrow in these patients. If it can, could~     this result in better outcomes after transplantation.~   "
117227|NCT01521598|"~     Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic~     peripheral neuropathy pain (DPN).~      Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with~     painful diabetic peripheral neuropathy.~      Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit~     from the double-blind phase because of inadequate pain relief.~   "
117228|NCT01521585|"~     The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is~     administered orally over 12 weeks to male and female patients with Huntington's Disease.~   "
117229|NCT01521572|"~     The aim of this study is to assess the bronchodilator response of salbutamol on respiratory~     mechanics of healthy individuals, smokers and COPD with varying degrees of airway~     obstruction.~   "
117230|NCT01521559|"~     This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week~     study to assess the efficacy and safety of Intravitreal Aflibercept Injection~     (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary~     to BRVO.~   "
117231|NCT01521546|"~     Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and~     cardiac muscle damage. Treatment of pulmonary complications has improved survival; however,~     heart muscle disease or cardiomyopathy has emerged as a leading cause of death, typically by~     the third decade. Although myocardial changes begin early, clinically significant heart~     disease is rarely detected in the first decade of life. Consequently, DMD cardiomyopathy~     frequently goes unrecognized (and untreated) until advanced (and irreversible).~      Current DMD cardiovascular care guidelines recommend beta-blockers and angiotensin~     converting enzyme inhibitors (ACEIs) when decreased ejection fraction (EF) is noted by~     echocardiography (echo); however, this strategy has not significantly improved outcomes. Our~     team has recently made a breakthrough in a mouse study, showing in a model that causes the~     same heart muscle disease in humans with DMD adding an old medicine traditionally used for~     high blood pressure and late-stage heart failure can actually prevent heart muscle damage.~     Because of this drug's proven safety in both children and adults, it is ready to be studied~     immediately in an RCT in patients with DMD to hopefully show, as we did in mice, that we can~     prevent the devastating consequences of heart muscle damage.~   "
117232|NCT01521533|"~     The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in~     combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in~     previously treated patients with multiple myeloma (MM).~   "
117233|NCT01521520|"~     Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells~     of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically~     silent with immune cells invading the pancreatic islets, a process termed insulitis, which~     eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed,~     the body can not make enough insulin to maintain blood sugars in the normal range and~     clinical diabetes develops. The purpose of this study is to assess the ability of magnetic~     resonance imaging with ferumoxytol to detect changes in the pancreas associated with the~     insulitis of type 1 diabetes.~   "
117248|NCT01521325|"~     This research is being conducted to determine the biodistribution of radiolabeled amatuximab~     in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including~     mesothelioma, pancreatic, ovarian or non small cell lung cancer.~   "
117249|NCT01521312|"~     Glucose ACCES study will explore the acute and long term (12-week treatment) effects of~     saxagliptin in patients with impaired glucose tolerance during fasting and after a~     standardised breakfast. The investigations will be performed on:~        -  glycemic parameters~        -  on cardiovascular parameters~   "
117234|NCT01521507|"~     The study objective is to evaluate the long-term treatment effectiveness for adult patients~     with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the~     LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy~     over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with~     other MGD and dry eye treatments over a duration of up to 12 Months.~      This is a post-market, non-significant risk, prospective and multi-center clinical trial~     divided into two stages. The first stage from enrollment to 3 Months is an open-label,~     randomized controlled design to compare the effectiveness of a single LipiFlow® System~     treatment to a standardized daily warm compress and eyelid hygiene Control therapy with~     Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage,~     occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness~     of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration~     of up to 12 Months. Subjects are entered into the following subgroups based on the subject's~     self-assessment of the adequacy of symptom relief and protocol-defined criteria for~     additional treatment.~        1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.~        2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.~        3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by~          other MGD or dry eye treatment, as prescribed by the physician.~   "
117235|NCT01521494|"~     To investigate dose-response efficacy and safety in hemodialysis patients with~     hyperphosphatemia.~   "
117236|NCT01521481|"~     The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided~     inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).~   "
117237|NCT01521468|"~     A large number of cardiac catheterizations are performed each year, primarily to diagnose~     heart disease. However, a cardiac catheterization is an invasive procedure which is~     associated with serious complications such as heart infarction, stroke, and death.~     Therefore, there is a need for non-invasive procedures to diagnose coronary heart disease.~     The purpose of this study is, therefore, to assess the diagnostic accuracy of non-invasive~     cardiac imaging modalities for the detection of heart disease in patients presenting for the~     first time to the cardiologist with chest pain.~   "
117238|NCT01521455|"~     The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide~     250 Diskus when repeatedly dosed to Asthmatic patients.~   "
117239|NCT01521442|"~     The primary objective of the current study is to establish the safety and acceptability of~     Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD)~     among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)~     Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga~     Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism~     of therapeutic action.~   "
117240|NCT01521429|"~     Approximately 85% of individuals with Mucopolysaccharidosis (MPS) type I, II, or VI report~     weekly pain and 50-60% have significant limitations in their activities of daily living due~     to MPS related musculoskeletal disease despite treatment with enzyme replacement therapy~     (ERT). Thus there is a critical need to identify additional therapies to alleviate the~     burden of musculoskeletal disease in order to improve the health and quality of life of~     individuals with MPS. However, disease progression needs to be quantified to be able to~     determine efficacy of new therapies. This study is a multi-institutional, 5-year,~     longitudinal study of musculoskeletal disease in MPS. The objective is to quantitatively~     describe the progression of skeletal disease and identify biomarkers that either predict~     disease severity or could be used as therapeutic targets in individuals with MPS I, II, and~     VI. A database of standardized measurements of musculoskeletal disease in MPS will allow the~     field to efficiently move forward with therapeutic clinical trials in patients with MPS.~   "
117241|NCT01521416|"~     The objective of this study is to describe the burden associated with influenza in the UK,~     from both primary and secondary care perspectives, and to stratify the burden by the annual~     degree of mismatch between predicted and actual virus strains.~   "
117242|NCT01521403|"~     The objective of this study is to determine whether in the setting of primary health care it~     is effective to treat with metronidazole returning travellers with gastrointestinal symptoms~     and B. hominis in the stool or not.~   "
117243|NCT01521390|"~     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being~     developed for the treatment of chronic obstructive pulmonary disease (COPD). The long~     duration of action of GSK573719, when administered via inhalation to humans supports the~     potential for use as a long acting bronchodilator.This is a randomized, double-blind,~     placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The~     study will measure lung function after single inhaled doses from two configurations of the~     Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters:~     sGaw, FEV1~   "
117244|NCT01521377|"~     This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT~     study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and~     GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with~     placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose~     treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with~     moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with~     moxifloxacin placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with~     moxifloxacin placebo on day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10.~     All treatments are double blind except for moxifloxacin (400mg) and moxifloxacin placebo~     controls, given as a single-blind single dose on Day 10 of the appropriate treatment period.~      Primary endpoints are individual time-matched changes from baseline QTcF for~     GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing~     on Day 10. Secondary endpoints will include individual time-matched changes from baseline in~     QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours~     after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and~     ventricular rate at each time point after 10 days dosing of each GSK573719 and~     GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from~     baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each~     treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of~     GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram~     (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical~     laboratory safety tests and collection of adverse events (AEs).~   "
117245|NCT01521364|"~     Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA)~     in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis~     (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in~     different Mycobacteria strains. The investigators observed increased LIN serum levels in~     three cases after combining LIN and CLA of which the investigators described one in a case~     report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic~     study in MDR- and XDR-TB patients to quantify the above described interaction between LIN~     and CLA.~   "
117250|NCT01521299|"~     This is an open label Phase I study with two parts. Part Two with SCH900776 in combination~     with hydroxyurea will not be pursued at this time.~      Part One investigates monotherapy with oral hydroxyurea. The primary objective is to~     determine whether a tolerated dose (TD) of hydroxyurea as a single agent can increase the~     percentage of tumor cells in S and G2 phase of the cell cycle. For this reason, all patients~     in Part One must have a tumor lesion accessible for a skin punch biopsy. Tumor biopsies will~     be obtained on two separate occasions: prior to hydroxyurea and at 16-18h after starting~     hydroxurea therapy on day 1 only.~      A baseline 12-lead ECG will be obtained from each study participant. Single-agent~     hydroxyurea will be administered on days 1, 8 and 15 of a 28 day cycle, for ONE cycle only.~     On these days oral hydroxyurea will be started in the late afternoon and administered every~     4 hours for a total of 6 doses.~      Venous (up to 10 mL) blood samples will be obtained at time zero (pretreatment), 30 min, 1h,~     1.5 2, 2.5, 3.0, 3.5 and 4h following the first oral dose of hydroxyurea, and pretreatment~     and at the same times following the sixth oral dose of hydroxyurea (i.e., 20, 20.5, 21,~     21.5, 22, 22.5, 23, 23.5 and 24 h).~   "
117251|NCT01521286|"~     The purpose of this study is to collect data on the incidence, complications and impact on~     quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This~     study will also collect data on costs related to the HZ disease, especially postherpetic~     neuralgia (PHN)~   "
117252|NCT01521273|"~     Iron deficiency and iron deficiency anemia are among the major health problems in the~     developing world. Women of childbearing age as well as children are the most vulnerable~     population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A~     promising approach to combat iron deficiency in Rwanda is biofortification of beans. The~     average consumption of beans is about 150 g per person per day in Rwanda and beans are a~     major staple food. Traditional plant breeding has increased the iron content of certain bean~     varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3%~     low because of high phytate and high polyphenol contents. A recently conducted study in~     Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was~     similar to the amount of iron absorbed from a control bean, which had a 50% lower iron~     concentration. This was surprising since the subjects had a low iron status and where~     therefore expected to maximize iron absorption. However, it was concluded that the~     additional iron bred into the bean was not bioavailable most likely due to the strong~     inhibitory nature of phytate in the high iron bean. To clarify that, a multiple meal study~     (iron absorption study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and~     the Medical Faculty of the National University of Rwanda is planned. Subjects will receive~     two different bean varieties (normal iron vs. high iron) in combination with other food~     ingredients typical for that region. The bean varieties will be served with native phytate~     concentration, partially dephytinized (50%) or totally dephytinized.~      Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption~     will be determined by stable isotope techniques.~   "
117253|NCT01521260|"~     Peri-implantitis is an infectious disease that resides in the mucosa surrounding dental~     implants and also affects the supporting bone. Because the number of implants placed in~     everyday clinical practice is continuously increasing, it is reasonable to anticipate an~     increasing prevalence of peri-implantitis. However, from the literature there is very little~     reliable evidence suggesting which could be the most effective interventions for treating~     peri-implantitis.~      The primary objective of this controlled clinical study is to evaluate the microbiological~     effect of decontamination of the implant surface during the surgical treatment of~     peri-implantitis using a chlorhexidine or placebo solution. The secondary objectives are to~     assess both the clinical and the microbiological effectiveness of treatment of~     peri-implantitis.~      It is hypothesized that rinsing of the implant surface using a 0.12% chlorhexidine solution~     does not lead to better microbiological and clinical results compared to rinsing with a~     placebo solution.~      The present study is a double-blind, placebo-controlled, randomized clinical trial.~      Adult patients with at least one endosseous implant in the oral cavity with clinical and~     radiographical signs of peri-implantitis will be included in this study.~      Implants with peri-implantitis lesions will be surgically exposed, followed by mechanical~     cleansing using curettes and gauzes and cotton pellets soaked in saline followed by either 1~     minute of rinsing with a placebo solution (saline with appearance of chlorhexidine) (control~     group) or 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium~     chloride (CPC) without alcohol (Perio-aid®) (test group). After 1 minute of saline rinsing~     the gingival flap will be returned slightly apical (in order to reduce pockets) and will be~     firmly sutured. For both groups the surgery is followed by 2 weeks of mouthrinses with 0,12%~     chlorhexidine + Cetylpyridinium Chloride (CPC) without alcohol (Perio-aid®) two times daily~     during 30 seconds.~      The main study parameter is the microbial composition of the biofilm on the dental implant~     surface. Secondary study parameters are bleeding on probing, probing pocket depth,~     suppuration on probing, microbiological composition of the peri-implant sulcus, radiographic~     marginal bone level on standardized intraoral radiographs, presence of plaque, presence of~     calculus, marginal soft tissue recession implant failure, complications and adverse events.~   "
117254|NCT01521247|"~     Despite the clear and often stated need, a formal transition program does not exist for~     asthma patients as they move from pediatric to adult care in Western Canada. This population~     is not having their health care needs met. The investigators proposed study would evaluate a~     well structured transition program designed to facilitate continuity of care for this at~     risk patient population.~      Primary hypothesis: A pediatric-to-adult asthma transition program will improve the~     asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year~     period.~      Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma~     control, decrease asthma exacerbations, and reduce health care utilization in young asthma~     patients in the Calgary area over a 1 year period.~   "
117255|NCT01521234|"~     Regaining independent walking is the top priority for individuals recovering from stroke.~     Thus, physical rehabilitation post-stroke should focus on improving walking function and~     endurance. However, the amount of walking completed by individuals with stroke attending~     rehabilitation is far below that required for independent community ambulation. There has~     been increased interest in accelerometer-based monitoring of walking post-stroke. Walking~     monitoring could be integrated within the goal-setting process for those with ambulation~     goals in rehabilitation. The purpose of this study is to determine the effect of~     accelerometer-based feedback of daily walking activity during rehabilitation on the~     frequency and duration of walking post-stroke.~   "
117256|NCT01521221|"~     The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension~     in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for~     comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes~     and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood~     pressure, heart rate and symptoms will be continuously measured. First study will evaluate~     the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before~     the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the~     position changes.~   "
117257|NCT01521208|"~     The goal of this study is to show the superiority in survival at hospital admittance and in~     neurological outcome on hospital discharge of continuous mechanical chest compression using~     LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital~     cardiac arrest.~   "
117258|NCT01521195|"~     The investigators propose to examine the relationship between DO2 and VO2 in critically ill~     patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can~     provide complete support of heart and lung function. In so doing, the investigators will be~     able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow~     through the ECMO circuit.~      Null Hypothesis:~      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is~     not associated with an increase in oxygen consumption.~      Alternate Hypothesis:~      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is~     associated with an increase in oxygen consumption.~   "
117259|NCT01521182|"~     The purpose of this study is to determine whether the regular consumption of the active~     product enhances the immune function, in comparison to the control product.~   "
117260|NCT01521169|"~     The purpose of this study is to investigate the effect of consumption of a drinkable low fat~     fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol~     (LDL-cholesterol) concentration during 12 weeks of product consumption.~   "
117261|NCT01521156|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in~     midly hypercholesterolemic people.~   "
117262|NCT01521143|"~     As < 10% of the necessary patients required by the protocol were recruited and the data were~     not intended to support a labeling claim, it was determined that the abbreviated clinical~     study report (CSR) was the appropriate reporting format. No efficacy analyses were performed~     as the trial was terminated early with incomplete enrollment of < 10%.~      The purpose of this study is to determine if an investigational cell therapy called Cvac can~     help epithelial ovarian cancer (EOC) from returning when administered to patients who are in~     complete remission after surgical removal of their tumor followed by standard first-line~     (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo~     leukapheresis for the manufacture of the study agent. After completion of chemotherapy and~     confirmation of remission, patients will enter the treatment phase of the study.~   "
117263|NCT01521130|"~     This project examines how seizures, and abnormal brain activity, affect language skill in~     children with Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS). BECTS is a~     common type of childhood epilepsy, and while BECTS patients stop having seizures by their~     late teenage years, many studies have shown that these children have language problems that~     may lead to academic and social difficulties. Using standardized language testing,~     monitoring of brain activity, and MRI brain imaging, this project aims to determine what~     particular combination of BECTS symptoms put children most at risk for language problems and~     whether treatment with anti-epileptic medications may be helpful.~   "
117264|NCT01521117|"~     This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and~     muscle rigidity. Current medications for the treatment of PD do not improve gait and balance~     difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls~     in individuals with PD. The mechanism in which this reduction of falls occurs is unclear.~     The investigators study will look at what aspects of gait and balance are improved by the~     study drug. The study drug is not approved to treat PD in the United States or other~     countries because we do not know enough about it.~   "
117265|NCT01521104|"~     Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of~     invasive depth of colorectal neoplasia.~   "
117266|NCT01521091|"~     Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make~     accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be~     the first choice.~   "
117267|NCT01521078|"~     Excessive alcohol consumption in university students continues for be a serious public~     health concern with a variety of negative consequences. There have been a number of~     different brief interventions developed to address this issue among university students. The~     current project will add to this literature by evaluating the use of a personalized feedback~     intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine~     whether providing access to the CYDU will result in short-term reductions in drinking. This~     issue is important as use of these interventions is not a mandatory requirement for~     university students so the issue is whether making materials of this type available leads to~     any reductions in risky drinking. It is hypothesized that students provided access to the~     CYDU will display greater reductions in drinking at a six-week follow-up as compared to~     students who were not provided access to the CYDU.~   "
117268|NCT01521065|"~     The purpose of this study is to confirm the clinical and economic benefits of IRay treatment~     with respect to the number of anti-VEGF injections and frequency of visits during the first~     year after treatment for patients with wet Age-related Macular Degeneration (AMD).~   "
117269|NCT01521052|"~     Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in~     elderly patients suffering from major depressive episode.~      Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above,~     currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil~     (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor~     threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will~     be conducted before starting the trial (screening), once a week for the trial duration and~     one month following end of treatment.~   "
117270|NCT01521039|"~     Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).~   "
117271|NCT01521026|"~     This research on cognitive training addresses the following questions:~        1. Does cognitive training lead to improved cognition, functional abilities, psychiatric~          symptoms, treatment adherence, or quality of life in patients with psychoses?~        2. What are the neurocognitive and non-cognitive factors that predict good outcomes~          following cognitive rehabilitation? In addition to verbal learning and memory,~          immediate verbal memory, vigilance, and executive functioning, the cognitive training~          intervention attempted to improve prospective memory ability (i.e., the ability to~          remember to do things in the future, such as take medications or attend a doctor's~          appointment).~   "
117272|NCT01521013|"~     When patients present with both a chronic disease and depression, family physicians agree~     that treatment and follow-up is more complicated and that patients' health suffers as a~     result. Programs to help depressed patients learn skills to help manage their mood have been~     developed (depression self-care), using workbooks and audio-visual materials. The programs~     show promise, but little is known about how these self-care programs may work for patients~     with depression and chronic disease.~      Researchers are proposing a study to evaluate a depression self-care programme for patients~     age 40 and over who have at least mild depressive symptoms as well as a chronic physical~     illness and who are treated primarily by a family physician. All study participants (250~     patients selected from different family medicine clinics in Montreal) will receive a package~     of depression self-care materials which include the Antidepressant Skills Workbook,~     developed in Canada, available in French and English, and used in several provinces in~     depression self-management programs; a video on depression; a mood monitoring tool; an~     information booklet to give to family members; and information on additional resources~     (books, internet materials, and local community groups). The participants will be assigned~     to one of two groups randomly (like a coin toss): one group will receive the materials only,~     the other group will receive the materials as well as regular telephone support for up to 6~     months by a trained coach who will answer any questions the participant may have on the~     materials they are working with.~      All participants who agree to be in the study will be interviewed three times: once at the~     beginning of the study, then at 3 months and finally at 6 months. Patients' depression~     scores will be evaluated to determine the effectiveness of the self-care programme with and~     without the support of the coach. Researchers will also look at the effect that self-care~     may have on use and costs of health services, and whether engaging in self-care has an~     impact on health behaviours (like exercise, taking medications correctly and smoking and~     alcohol consumption).~      All study data will be anonymous; any information that could potentially allow~     identification of a participant will be removed.~   "
117273|NCT01521000|"~     Primary Objective: To determine whether early intervention (with garment sleeve and~     gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.~      Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to~     measure pre-clinical and clinical lymphedema.~      Tertiary Objective: To determine whether bioimpedance analysis is better than the gold~     standard of volume displacement to measure lymphedema.~      The successful completion of this study will address whether bioimpedance analysis is a~     reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we~     intend to evaluate whether bioimpedance analysis is better than the gold standard of volume~     displacement for measuring lymphedema. And most importantly, we will evaluate whether a~     short trial of compression garments in women identified to have pre-clinical lymphedema can~     actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the~     research and findings of this study, which may have future bearing on the post-operative~     therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.~      Study Design:Randomized, Pilot Study~   "
117274|NCT01520987|"~     To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects~   "
117275|NCT01520974|"~     The purpose of this study is to determine if an oral probiotic tablet taken once a day for~     twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and~     gum disease in a dentally healthy, young adult population.~   "
117276|NCT01520961|"~     Hueter anterior approach as described by Siguier allows an anatomical approach without~     muscle or tendon sections. It minimizes the rate of dislocation after primary total hip~     arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.~      The investigators hypothesis was Hueter anterior approach allows quicker functional recovery~     after partial hip replacement.~   "
117277|NCT01520948|"~     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of~     tremor, slowness of movement, and stiffness, leading to progressive disability and loss of~     independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI),~     urgency, and/or nocturia, are common non-motor symptoms that further diminish the already~     compromised quality of life for adults living with PD. Behavioral interventions for UI -~     including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized~     controlled trials and are free of side effects. Exercise-based behavioral therapy for UI~     requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral~     strategy that incorporates the PFME to suppress urinary urgency and prevent UI.~      We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based~     behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI~     severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be~     randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to~     achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month~     follow-up is planned in the treatment group.~      We hypothesize that:~        1. PD participants who are randomized to the exercise-based behavioral therapy group~          (Group A) will report a significant reduction in weekly frequency of UI episodes~          compared to PD participants in the behavioral control group (Group B). The primary~          outcome, frequency of UI, will be measured using a seven-day bladder diary.~        2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will~          be clinically meaningful as measured by a corresponding improvement on questionnaires~          of satisfaction and quality of life as well as a decline in other urinary symptoms~          including urgency and nocturia.~   "
117278|NCT01520935|"~     The study will assess the burden of influenza by age, risk status, vaccination status and~     influenza subtype, in order to create a complete profile of the burden of influenza-related~     morbidity and mortality in United Kingdom from 1996 to 2008.~   "
117279|NCT01520922|"~     This is a Phase II, open label, single arm, multi-centre study investigating the safety and~     efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL.~      Each subject from the screening phase who is willing to participate in the study and is~     found eligible according to the inclusion and exclusion criteria will enter the treatment~     phase and will receive a maximum of 6 Cycles of study treatment (ofatumumab plus~     bendamustine). All subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3).~     Eligibility to receive study treatment for Cycles 4, 5 and 6 will be assessed following the~     3rd Cycle. Subjects who have achieved at least stable disease with acceptable toxicity~     following 3 Cycles of treatment will be eligible to continue to receive study treatments for~     a maximum of 3 further Cycles. In case of progressive disease, at, or at any time after the~     start of Cycle 4, subjects must discontinue further study treatment and move into the~     study's follow-up period.~      During the treatment phase, all eligible subjects will be allocated to receive the following~     study treatments:~        1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle~          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days)~          in combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2,~          Days 1 and 2, every 28 Days).~        2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle~          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days)~          in combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2,~          Days 1 and 2, every 28 Days).~      The studies primary endpoint is overall response rate (ORR) as determined by Investigator~     evaluation. The ORR is the percentage of subjects achieving an objective response (i.e.,~     partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments~     are planned at the following time-points: After 3 Cycles of ofatumumab plus bendamustine~     treatment, after 6 Cycles of ofatumumab plus bendamustine treatment and after the last dose,~     if not after 6 cycles, of ofatumumab plus bendamustine treatment.~      Follow-up assessments will be performed every 3 months following the last study treatment.~     The follow-up period will last for a maximum of 3 years. Response evaluation assessments to~     determine subject response or progression will be performed during the follow-up period,~     according to the IWCLL updated NCI-WG guidelines. Following progression, only survival~     status and details concerning the subject's next CLL therapy will be recorded.~   "
117280|NCT01520909|"~     The purpose of this study is to investigate the efficacy, safety and tolerability of~     eltrombopag in children with previously treated chronic immune thrombocytopenia who are~     between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be~     randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete~     part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.~   "
117281|NCT01520896|"~     Study in healthy volunteers to investigate the effects of Ketoconazole on the~     Pharmacokinetics of NKTR-118~   "
117282|NCT01520883|"~     Many patients suffering from asthma are not compliant to their treatment and consequently,~     are not well controlled. Shared decision making intervention has shown an improvement in the~     outcome of patients with chronic disease. The aim of this study is to evaluate decisional~     conflict and to assess decisional needs of adults with asthma.~   "
117286|NCT01520831|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate a difference~     between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic~     insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.~   "
117287|NCT01520818|"~     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control~     of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30~     treatment.~   "
117288|NCT01520805|"~     The purpose of this study is to determine whether CPI-613 is effective and safe in either~     patients with refractory or relapsed acute myeloid leukemia (AML) or patients with~     myelodysplastic syndrome (MDS) who have failed therapy with a hypomethylating agent (such as~     decitabine [Vidaza] and azacitidine [AZA]).~   "
117289|NCT01520792|"~     Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on~     its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now~     considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a~     pro-drug.~      Indeed, it has been shown that paracetamol may have a deleterious effect, especially in~     vulnerable populations (hepatic insufficiency, elderly). First results showed a very~     significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of~     acetaminophen, which involves enzymes such as cytochrome P450.~      Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased~     detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to~     explain the results.~      Clinical studies showed a great variability of pain assessment by patients and variability~     in the metabolic response of paracetamol. Genetic factors probably play a role remains~     largely unknown.~      The review of the literature on genetic polymorphism shows the involvement of a number of~     enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but~     without connection with its analgesic effect. This is a critical missing link in the~     understanding of the analgesic effect of paracetamol.~   "
117290|NCT01520779|"~     analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular~     carcinoma within 1 year after radiofrequency ablation.~   "
117291|NCT01520766|"~     A randomized parallel-group clinical pilot study was designed to evaluate the impact of~     glass fiber reinforced composite posts compared to prefabricated titanium posts on long term~     survival of adhesively restored endodontically treated abutment teeth.~   "
117292|NCT01520753|"~     This trial is conducted in Europe. The aim of this trial is to compare two different active~     treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.~   "
117293|NCT01520740|"~     This study will evaluate the effects of baseline collateral ventilation status on outcomes~     following treatment with AeriSeal System in patients with advanced upper-lobe predominant~     heterogenous emphysema.~   "
117294|NCT01520727|"~     The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and~     catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after~     single oral ascending doses.~   "
117295|NCT01520714|"~     The purpose of this study is to determine whether changes in a patient's position affect LV~     capture thresholds in a clinically significant way.~   "
117296|NCT01520701|"~     The investigators hope to get by reduced and delayed acute radiodermatitis following the~     application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and~     improved quality of life of patients with head and neck cancer treated with concomitant~     radiotherapy.~   "
117297|NCT01520688|"~     Children with mild persistent asthma that have asthma symptoms once or twice a week and use~     a daily controller, while children with mild intermittent asthma rarely have asthma symptoms~     and do not use a daily controller. Inhaled corticosteroids are the standard treatment for~     mild peristent asthma. The purpose of this study is to measure children rate of growth while~     on different inhaled corticosteroids.~   "
117298|NCT01520675|"~     Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by~     destruction of pancreatic parenchyma and subsequent fibrosis. Patients with chronic~     pancreatitis can be treated with medical management, endoscopic therapy and surgical~     treatment. Among the various theories of causation of pain in chronic pancreatitis, there is~     theory of ductal hypertension. In this the pancreatic duct obstruction resulting in ductal~     dilatation, ductal hypertension and parenchymal hypertension is thought to be the cause of~     pain. For patients with dilated ducts, ductal decompression is advocated. Ductal~     decompression can be achieved by endoscopy and by surgery. Surgery comprises of lateral~     pancreaticojejunostomy with or without headcoring. Endoscopic treatment includes~     sphincterotomy, dilatation of strictures, removal of stones with or without extracorporeal~     shock wave lithotripsy (ESWL) and stenting. The pros and cons of endoscopic versus surgical~     therapy are debated. Lateral pancreaticojejunostomy relieves chronic abdominal pain in~     65%-93% of patients. Morbidity and mortality rates are generally low, averaging 20% and 2%,~     respectively. Long-term follow-up of patients after lateral pancreaticojejunostomy reveals~     that up to 50% of patients develop recurrent symptoms and 10%-35% fail to obtain pain~     relief. Studies indicate that more than 60% of patients undergoing pancreatic endotherapy~     are pain free 1 year after the procedure. There are only two randomized controlled trials~     comparing endoscopic treatment with the surgical therapy. In this study the investigators~     will be conducting a randomized trial, to compare endoscopic and surgical treatment of~     chronic pancreatitis. Outcome variables measured in the study will include pain relief,~     quality of life, morbidity, mortality, length of hospital stay and changes in pancreatic~     function.~   "
117299|NCT01520662|"~     Building upon our experience with a very sophisticated preventive services prompt and~     reminder system, the Preventive Services Reminder System (PSRS), the investigators propose~     to conduct a systematic three-year study with the following aims:~        1. To develop, field test, and refine an Internet-based patient Wellness Portal linked to~          PSRS to facilitate patient-centered, preventive care in primary care practices;~        2. To determine the impact of the Wellness Portal on the process of patient-centered~          preventive care by examining the behavior and experiences of both patients and~          providers and the degree to which recommended services are individualized; and~        3. To develop model Wellness Portal practices and disseminate the Wellness Portal~          technology and knowledge derived from Aims 1 and 2 findings.~   "
117300|NCT01520649|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in~     depressed human subjects study.~   "
117301|NCT01520636|"~     This study is designed to observe the respective effects of 2 types of physiotherapy early~     after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered~     (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative~     physiotherapy aiming at preventing complications.~   "
117377|NCT01519648|"~     Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute~     leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of~     chemotherapy), and hematopoietic stem cells transplantation.~   "
117302|NCT01520623|"~     Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative~     treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT,~     called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an~     immune response against healthy recipient cells leading to a graft-versus-host disease~     (GvHD) in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the~     gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality~     after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in~     the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD~     without affecting the GvL effect. According to GVHD experimental models, it is likely that~     GvL but not GvHD may occur in the absence of inflammatory signals induced by the~     transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the~     role of Complement system in patients who received allogeneic HSCT. Indeed, Complement~     system is a major actor of inflammation and in the generation of tissue destruction, both of~     which are involved in the physiopathology of GVHD. Furthermore, it might be a potential~     target of some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a~     preventive or curative manner in such patients. Preliminary data obtained from 34~     allografted patients in our institution suggest that Complement activation by the classical~     pathway is correlated to the occurrence of GI GVHD. The goal of our current project, in~     order to confirm these preliminary results in a larger series, is to explore Complement~     system activation in patients who received allogeneic HSCT in three Adult Hematology~     departments in Paris fot two years and to correlate the biological results to the clinical~     events occurring after HSCT.~   "
117303|NCT01520610|"~     This is a case-control association study with multicentric prospective recruitment.~      Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It~     is characterized by reversible left ventricular dysfunction that is frequently precipitated~     by a stressful event and most of patients are postmenopausal women.~      Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed,~     but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the~     investigators don't know why some patients with stressful event may present Tako-TSUBO~     cardiomyopathy whereas most of them don't.~      The investigators hypothesize that polymorphisms in the genes involved in the adrenergic~     pathway resulting in greater catecholamine sensitivity would be associated with an increased~     risk of Tako-TSUBO cardiomyopathy.~   "
117304|NCT01520597|"~     Listeriosis is a foodborne infection responsible for severe disease. Three main forms are~     described: septicaemia, central nervous system infections and maternal-fetal infections.~     Available data on the disease, are mostly retrospective and do not provide an accurate~     picture of the clinical / biological / genetic risk factors for the disease, nor identify~     any element to determine which patients are at higher risk of death, severe neurological~     impairment or fetal loss.~      The primary purpose of the study is to identify clinical, biological and genetic risk~     factors for systemic listeriosis and the determinants of listeriosis-associated mortality in~     the setting of a large prospective nation-wide study.~   "
117305|NCT01520584|"~     The vitamin,minerals and amino acid supplementation for 3 months will improve the semen~     parameters,fertilization rate and embryo quality in subfertile men undergoing IVF treatment~   "
117306|NCT01520571|"~     The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide~     better alignment and clinical function? (2) Do computer-assisted TKAs provide better~     survivorship of implants and less complication? and (3) Do correction of the mechanical axis~     of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery~     due to aseptic loosening?~   "
117307|NCT01520558|"~     This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1~     clinical study designed to examine the safety of infusing escalating doses of~     CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative),~     after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia~     (AML) who are in their first complete remission at the time of enrollment, are not~     candidates for stem cell transplant, and are considered to be at high risk for recurrence.~   "
117308|NCT01520545|"~     Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable~     pump~   "
117309|NCT01520532|"~     The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral~     lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed~     using best practices, including optimized procedural techniques and anti-coagulation~     therapy.~   "
117310|NCT01520519|"~     The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with~     rituximab can help to control CLL and SLL. The safety of this combination will also be~     studied.~      Ibrutinib is designed to stop a protein from working in the cells, which may cause the~     cancer cells to die or stop growing.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells~     to die.~   "
117311|NCT01520506|"~     The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF)~     energy through the wall of the renal artery to denervate the human kidney.~   "
117312|NCT01520493|"~     Pulmonary artery hypertension (PAH) is a rare, severe disease, characterized by a~     progressive increase in pulmonary vascular resistance ultimately leading to right~     ventricular (RV) failure and premature death. PAH may be idiopathic (IPAH) or may be also~     related to various conditions like portal hypertension, HIV infection, left to right shunt,~     connective tissue diseases such as scleroderma (PAHSSc). Symptoms include dyspnea and~     fatigue resulting in restricted exercise capacity and poor quality of life. The therapies~     currently approved have been shown to improve survival. Indeed, recent studies described a~     three year survival higher than 80%. This improved survival is associated with major~     challenges for clinicians as most patients remain with limited exercise capacity and poor~     quality of life. A clear understanding of exercise physiopathology is thus mandatory to~     specifically address mechanisms responsible for this exercise limitation and eventually~     improve patients' management. In order to better characterize the exercise physiopathology~     in PAH, the general objective of this research is to systematically examine blood flow~     distribution and limb muscles microcirculation at rest and during submaximal exercise in~     PAH.~   "
117313|NCT01520480|"~     In this study, the investigators analyze a consecutive series of patients operated for~     pathological subtrochanteric femur fracture to describe survival and reoperation rates after~     surgery and to identify risk factors for death. Moreover, the investigators include a cohort~     of patients with non-pathological subtrochanteric fractures for comparison.~   "
117423|NCT01519050|"~     The aim of the study is to investigate whether a predictive score (combination of several~     validated predictors) better predicts postoperative left ventricular function than any~     single predictor in patients undergoing mitral valve repair for degenerative mitral~     regurgitation.~      A single center, prospective cohort study~   "
117314|NCT01520467|"~     There is currently no drug with pediatric marketing authorization capable of limiting the~     advance in bone maturation of children with aggressive adrenarche. Estrogens are the~     principal actors involved in bone maturation and premature epiphyseal fusion. Aromatase~     inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of~     androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear~     to be well tolerated in children and are sometimes used within the framework of clinical~     trials to limit bone maturation and improve prognosis with respect to final size, notably in~     children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data~     reported are based on small sample sizes and do not include children with pathological~     adrenarche.~   "
117315|NCT01520454|"~     Obese people have elevated levels of the hormone leptin. Despite this, they seem to be~     resistant to the effects of this hormone, which usually regulates appetite and energy~     expenditure. This is similar to what happens with insulin levels in the obese.~      It has been shown that obese people also have higher levels of free fatty acids in the blood~     when compared with lean people, and that this may cause impaired effect of insulin. The~     investigators believe that elevated free fatty acids may also affect leptin function. In~     this study, the investigators are increasing the levels of free fatty acids in healthy~     volunteers and looking for effects on leptin function before and after.~   "
117316|NCT01520441|"~     This is a pilot study examining biological endpoints in men with localized prostate cancer~     who are scheduled to have radical prostatectomies and men with Benign Prostatic~     Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A~     (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections~     into the right peripheral and transition zones and sham saline injections into the left~     peripheral and transition zones.~   "
117317|NCT01520428|"~     The purpose of this study is to evaluate the effectiveness of diabetes management training~     combined with the method of Motivational Interviewing with elements of Cognitive Behaviour~     Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range~     13-20 years) compared to a control group. The investigators assess motivational changes and~     effects on metabolic control.~   "
117318|NCT01520415|"~     The objective of this study is to examine the short and long-term effect of myofascial~     trigger point injections with either a local anesthetic or saline in patients with chronic~     low back pain presenting with myofasical pain syndrome.~   "
117319|NCT01520402|"~     The purpose of this study is to determine the importance of genetic differences on~     individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by~     the trade name Coumadin and is in a class of medications called anticoagulants or blood~     thinners. Warfarin works by reducing the blood's ability to make clots. It is used to stop~     blood clots from forming or growing larger in your blood and blood vessels. Warfarin is~     prescribed for many conditions, including for people with certain types of irregular~     heartbeat, people with replacement or mechanical heart valves, people who have suffered a~     heart attack, people who have had orthopedic surgery, or who have a history of having blood~     clots. Warfarin is used to prevent or treat deep vein thrombosis (swelling and blood clot in~     a vein), pulmonary embolism (a blood clot in the lung), and strokes (a blood clot in the~     brain). Researchers have found that certain genes may affect how a person's body will break~     down or react to warfarin. If genetic information can help doctors better determine the best~     dose of warfarin before it is first given, this may help the doctors get patients to the~     correct levels of blood thinning and thereby reduce the risk of bleeding or the risk of~     developing a blood clot. The expectation of this study is that this information will~     ultimately improve warfarin therapy while lessening the risks associated with dosing errors.~     This study is considered investigational because the subjects are healthy and not being~     prescribed warfarin for clinical care.~   "
117320|NCT01520389|"~     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3~     design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in~     combination with irinotecan.~   "
117321|NCT01520376|"~     This study will try to elucidate wheter the impact of a psychiatric intervention in patients~     hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting~     at 1 and 6 month after discharge.~   "
117322|NCT01520363|"~     Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo~     controlled clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the~     Pediatric Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger~     Institute.~      Funding Source- FDA OOPD and the Johns Hopkins Institute for Clinical and Translational~     Research (ICTR).~      It has been shown that receptors for a certain brain chemical called glutamate, in~     particular the NMDA type, are increased in the brain of young RTT patients (<10 years of~     age). This chemical and its receptors, when in excess, cause harmful over-stimulation of~     nerve cells in the brain, contributing in part to the seizures, behavioral problems, and~     learning disabilities in RTT.~      The investigators propose to initiate a specific treatment using DM to counter/block the~     effects of this brain chemical and its excessive receptors to improve the ill effects of~     increased glutamate/NMDA receptors, because of DM's identified ability to block NMDA~     receptors. DM is available for human consumption. Infants and children with respiratory~     infections and cough, as well as non-ketotic hyperglycinemia, are treated with DM, which has~     been well tolerated.~   "
117334|NCT01520207|"~     Kidney failure can result from a variety of conditions and can be temporary or permanent.~     Hemodialysis is available as a replacement treatment to perform the work that the kidneys~     normally do. However, the dialysis procedure can be associated with rapid changes in the~     composition of the blood - this may lead to changes in blood pressure and in turn reduced~     blood supply to important parts of the body. We aim to investigate if giving a medicine~     (called mannitol) during dialysis may be able to reduce the frequency of these low blood~     pressure events.~   "
117335|NCT01520194|"~     Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and~     the lack of studies about both the economic and the psychosocial burden of these diseases,~     BEMFAM, a Brazilian non-governmental organization that provides reproductive health services~     and technical support to local governments proposes a study to measure the psychosocial and~     economic burden of genital warts.~   "
117323|NCT01520350|"~     Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to~     other antipsychotic agents, especially because of its partial dopaminergic agonistic~     activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the~     5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties~     should enable this molecule to provide antidepressant potentiating capabilities based on~     what has been observed with other compounds sharing similar pharmacological profiles.~      Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the~     treatment of unipolar depression. However, two randomized controlled trials of aripiprazole~     in the treatment of bipolar depression were negative. This surprising result may stem from~     the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3~     mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit~     dopaminergic activity in key brain areas involved in the modulation of rewards, motivation~     and concentration. Bipolar depression is indeed heavily loaded with general symptoms of~     psychomotor retardation including poor concentration, low energy level, hypersomnolence, and~     hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving~     dopaminergic function are used frequently to resolve residual symptoms of bipolar~     depression.~      It is expected that aripiprazole used at a more adequate lower dose than in previous~     studies, should be efficacious in the treatment of bipolar type I depression.~   "
117324|NCT01520337|"~     Polyp detection rate in colonoscopy following oral administration of MMX methylene blue~     tablets~   "
117325|NCT01520324|"~     Evaluation of the intraepithelial neoplasia detection rate in patients with long standing~     ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to~     colonoscopy.~   "
117326|NCT01520311|"~     The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph~     (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of~     Duplex Sonography Results and coronary angiography and major cardiovascular or~     cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein~     (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.~   "
117327|NCT01520298|"~     This research study is a prospective, randomized, blinded, placebo controlled trial~     evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip~     fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not~     have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered.~     All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo~     surgical intervention are eligible to participate. Hip fractures affect greater than 300,000~     geriatric patients annually, representing the second leading cause of hospitalization for~     this patient population. Pain control in these patients is often problematic due to~     co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects~     may receive the normal DVT prophylactic treatments post-op.~   "
117328|NCT01520285|"~     This study will be compare Felodipine sustained-release tablets, to Lercanidipine~     hydrochloride tablets (Zanidip®) for the treatment of patients with mild-to-moderate primary~     hypertension and to investigate the influence on patients' heart rate and blood pressure~     variability.~   "
117329|NCT01520272|"~     Background:~      - Cervical cancer is one of the leading causes of cancer death in women worldwide and in~     Uganda. It is caused by the human papillomavirus (HPV). A vaccine against HPV was offered~     for all 10-year-old girls in the Nakasongola district of Uganda from October 1, 2008, to~     October 31, 2009. The HPV vaccine requires three doses; however, some girls received only~     one or two doses. Researchers want to compare vaccine immunogenicity in girls who received~     all three doses with those who had only one or two doses.~      Objectives:~      - To examine the immunogenicity (antibody levels) of girls in Uganda who received only one,~     two or three doses of HPV vaccine.~      Eligibility:~        -  Girls who will be at least 12 years old by October 31, 2011, and had at least one dose~          of the HPV vaccine.~        -  All participants will come from the Nakasongola district of Uganda.~      Design:~        -  Participants will have a physical exam and answer questions about their medical history~          and HPV risk.~        -  Participants will provide a single blood sample for testing.~        -  Treatment and vaccines will not be provided as part of this study. Girls who did not~          receive all three doses of the HPV vaccine will be given information about the nearest~          health center. Health centers will provide the missed doses free of charge.~   "
117330|NCT01520259|"~     Background:~      - Chile has the highest diagnosis and death rates of gallbladder cancer in the world.~     Gallbladder cancer is also the leading cause of cancer death in Chilean women. High rates of~     gallstones and obesity, as well as genetic concerns, may explain these high rates.~     Researchers want to study gallbladder cancer in more depth in Chile. A small study must be~     done to see if a full-scale study is feasible.~      Objectives:~      - To test the methods and procedures of a small-scale study of gallbladder cancer in Chile.~      Eligibility:~        -  Individuals at least 18 years of age who have gallbladder cancer or gallstones, or are~          healthy control volunteers.~        -  Participants will be recruited from four clinical centers in Chile.~      Design:~        -  Participants will be screened with a physical exam and medical history. Because~          gallbladder cancer has a high fatality rate, family members may be asked to provide~          additional medical history information if study participants die or become too ill to~          provide this information.~        -  Participants will provide blood, urine, stool, hair, fingernail, and saliva samples.~        -  Gallstones, bile, and tissue samples will be collected from those who have gallbladder~          removal surgery. Normal and tumor tissue samples will be collected as needed.~        -  Treatment will not be provided as part of this protocol. This is a data collection~          study only.~   "
117331|NCT01520246|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors identify and learn more about biomarkers related to cancer. It may also~     help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in samples from patients with T-cell~     acute lymphoblastic leukemia.~   "
117332|NCT01520233|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in RNA and predict how patients will~     respond to treatment. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies gene expression in predicting outcomes in samples from~     patients with high-risk neuroblastoma.~   "
117336|NCT01520181|"~     Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common~     symptom whereas life-threatening anaphylaxis is rather rare. A recently published study~     (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described~     the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients,~     disregarding their penicillin skin test results. In the proposed study the investigators~     will similarly challenge beta-lactam allergic patients, both children and adults for an~     extended (5 days) period of time. The study will include patients with a history of a skin~     rash following beta-lactam administration as well as patients who cannot provide any data on~     their presumed allergic reaction, disregarding their penicillin skin test results.~   "
117337|NCT01520168|"~     From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh~     was implanted in an estimated 350,000 patients worldwide.~      The purpose of the study is to evaluate retrospectively the complications related to this~     mesh that occurred in our patients between 2003 and 2005, since new complications continue~     to be diagnosed, although the investigators discontinued the use of the mesh.~   "
117338|NCT01520155|"~     The key of this prospective study is to identify a potentially increased cardiovascular risk~     in patients with systemic Lupus erythematodes, with and without renal affection. Three~     groups of patients will be compared.~   "
117339|NCT01520142|"~     The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398~     using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.~   "
117340|NCT01520129|"~     The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social~     Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are~     currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake~     and social rhythm patterns in study participants using questionnaires and actigraphy.~     Primary aims of this study are to evaluate feasibility of this treatment and assessment~     approach. Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in~     subthreshold BP, 2) impact of IPSRT on symptoms and functioning over time and 3)~     relationship between sleep-wake and social rhythm patterns and treatment outcomes.~   "
117341|NCT01520116|"~     This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary~     efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or~     latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the~     first portion, approximately 75 subjects will be randomized to receive either ATS907 or~     vehicle eye drops for up to 28 days, administered both once and twice daily. In the second~     portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for~     up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of~     the study.~   "
117342|NCT01520103|"~     The purpose of this study is Examination of the superiority of a combination of vinorelbine~     with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in~     advanced breast cancer.~   "
117343|NCT01520090|"~     Starting from Jan 2012 for an interval of 4 months with minimum number of 1200 egyptian~     women will be asked to complete a questionairre to evaluate their knowledge of different~     contraceptive methods~   "
117344|NCT01520077|"~     Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take~     vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth.~      The investigators hypothesize that Vytorin medication may have an effect on the inflammatory~     process of alopecia areata. Inactivating the inflammatory process may help in permitting~     hair regrowth in those subjects.~   "
117345|NCT01520064|"~     -  Obtain and analyze medical record data on patients with advanced emphysema who receive~          treatment with the AeriSeal System to better understand safety and effectiveness in the~          post-market setting;~        -  Provide participating physicians access to specified data sets for the purpose of~          generating scientific manuscripts about the effects of AeriSeal System treatment.~   "
117346|NCT01520051|"~     Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory~     tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma~     frequently suffer from exacerbations, which can be triggered by allergens and, in~     particular, viral respiratory infections. It has recently been shown that mepolizumab, a~     humanized monoclonal antibody that neutralizes interleukin(IL)-5, markedly reduces the~     exacerbation rate in asthma patients with eosinophilic airway inflammation. Previous studies~     have indicated that in a mixed population (eosinophilic and non eosinophilic) of mild asthma~     patients, mepolizumab did not have an impact on lung function and asthma symptom scores upon~     allergen provocation, although it did on markers such as sputum and blood eosinophils.~     Together, these observations led to the hypothesis that mepolizumab treatment reduces the~     exacerbation rate by limiting virus-induced asthma exacerbations.~      The investigators hypothesize that neutralization of IL-5 during virus infection in patients~     with allergic asthma:~        1. Reduces virus-induced bronchial inflammation~        2. Attenuates virus-induced asthma symptoms, airflow limitation and bronchial~          hyperresponsiveness.~        3. Enhances cellular immune responses to the virus.~      The aims of this study are to:~        1. To investigate whether IL-5 neutralization reduces the inflammatory response to viral~          airway infections in allergic asthma patients~        2. To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during~          virus-induced asthma exacerbations~        3. To investigate whether IL-5 neutralization affects the cellular immune response to~          viral airway infections in allergic asthma patients~   "
117347|NCT01520038|"~     Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in~     the United States. The primary objective of the feasibility/Phase I portion of the study is~     to establish the feasibility and safety of proton and the safety of IMRT for patients with~     pure or mixed variant urothelial carcinoma.~   "
117348|NCT01520025|"~     Coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood~     to the heart muscle. Diagnosis in patients with symptoms of chest pain is now quickly done~     with CT coronary angiography. This x-ray test can show narrowed blood vessels but has~     limited ability to predict the severity of the narrowings in some cases. We have described a~     new approach using PET exercise 18F-FDG imaging as a method to image areas of heart muscle~     not getting enough blood during exercise stress. The 18F-FDG images are co-registered with~     the CT anatomy from the CTA to provide direct evidence of the consequences of the narrowing.~   "
117350|NCT01519999|"~     The purpose of this study is to increase colorectal cancer screening by implementing a~     community-wide shared decision-making (SDM) intervention, which embeds shared decision~     making within clinical practice and also uses an extensive community engagement campaign.~     The investigators hypothesize that colorectal cancer screening adherence will be higher in~     the intervention group (participating communities) compared to the usual care control group~     (non-participating comparison communities).~   "
117351|NCT01519986|"~     The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3~     (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal~     associated with the administration of the supplement.~   "
117352|NCT01519973|"~     Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging~     technique that is used extensively to study the heart and diagnose heart disease. There are~     three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the~     signal in the patient tissues and resolution, where the signal gets blurrier the further the~     nuclear activity is away from the camera. New software, Evolution for CardiacTM, by GE~     Healthcare and new cameras with computed tomography (CT) decrease the time needed for images~     to be obtained while maintaining image quality. Evaluation is needed before they become~     standard of care.~   "
117353|NCT01519960|"~     This parallel group, open label study will evaluate the safety and efficacy of Pegasys~     (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at~     baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and~     without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg~     subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with~     advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment~     with Pegasys. Children in the untreated control Group B who have not experienced~     seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of~     Pegasys treatment. This offer will be available for 1 year following 48 weeks from~     randomization. Anticipated time on study treatment is 48 weeks. All subjects will be~     followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B)~     period.~   "
117354|NCT01519947|"~     This comparative, open-label, multicenter, parallel-group study will evaluate the effect of~     altitude on dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to~     achieve a target haemoglobin concentration of 11-12 g/dL in patients with chronic renal~     anemia in pre-dialysis and dialysis. Four groups of patients, at sea level or an altitude~     above 6'000 feet and in pre-dialysis or dialysis, will receive 50-250 mcg Mircera~     subcutaneously according to local label. Anticipated time on study treatment is 36 weeks.~   "
117355|NCT01519934|"~     Up to 120 subjects within the study site's practice who have already had an Ultherapy™~     treatment to the face and neck will be enrolled to monitor treatment effectiveness.~     Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained~     at each follow-up visit.~   "
117356|NCT01519921|"~     This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in~     patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A~     (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS~     180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of~     treatment-free follow up.~   "
117357|NCT01519908|"~     The purpose of this study is to investigate: the relation of a set of (bio)markers and~     response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the~     potential predictive power of these (bio)markers on improvement and/or deterioration of~     cardiac function, cardiac geometry (reverse re-modeling during CRT) will be evaluated.~      (Bio)markers include but are not limited to: collagen, genomic markers, molecular markers,~     electrocardiographic markers, echocardiographic markers, arrhythmogenic markers and markers~     for renal function: blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate~     (GFR).~   "
117358|NCT01519895|"~     The purpose of this study is to assess the effectiveness of the telephone intervention~     program for caregivers of colorectal cancer.~   "
117359|NCT01519882|"~     This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the~     effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and~     night-time movement in bed, in patients with advanced Parkinson's disease.~   "
117360|NCT01519869|"~     This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant~     chemotherapy followed by interval surgical debulking with platinum-based adjuvant~     chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable~     survival, decreased morbidity, and increased quality of life in patients with International~     Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or~     fallopian tube cancer when compared to historical controls and to evaluate the hypothesis~     that cancer induced inflammation is a predictor of poor prognosis and response to therapy in~     this group of ovarian cancer patients.~   "
117361|NCT01519856|"~     Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of~     Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is~     unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has~     adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from~     the literature that the antagonistic properties of piribedil are correlated with an~     improvement of cognitive function and vigilance parameters in parkinson's disease. The aim~     of the present non-interventional study is to investigate the safety and efficacy of~     piribedil during long-term therapy of patients with M. Parkinson under consideration of~     cognitive functions and quality of life.~   "
117362|NCT01519843|"~     Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve~     motor learning.~      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying~     motor learning in healthy volunteers and in chronic stroke patients.~   "
117375|NCT01519674|"~     This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical~     trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30~     (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various~     regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or~     without other oral anti-diabetic drugs (OADs)).~      The trial is conducted as a phase 4 trial in the majority of the participating countries.~     However, in some countries the trial is conducted as phase 3b.~   "
117363|NCT01519830|"~     Depletion of iron stores is frequently observed in regular blood donors, but effects of iron~     deficiency on general health is not well studied. Recent studies in women suffering of~     fatigue suggest iron deficiency without concomitant anemia as a common cause of these~     complaints. Provided the same is true in healthy subjects, substitution of intravenous iron~     might result in an improvement of general well being in iron depleted blood donors.~      Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will~     be invited to participate in a randomized, placebo-controlled trial with substitution of~     intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and~     other factors of general health and well being will be assessed. If an improvement of such~     factors can be shown after iron replacement, relevant concerns about artificially lowering~     iron stores by repeated phlebotomies will arise and changes of monitoring and substitution~     policies in blood banking might have to be discussed.~   "
117364|NCT01519817|"~     Background:~      - Cancer vaccines are being developed to help teach the body's immune system to attack and~     destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is~     present in some tumor cells, and it can help tumor cells spread to other parts of the body.~     Researchers want to see whether the new Brachyury protein vaccine can help treat people with~     advanced carcinomas.~      Objectives:~      - To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in~     tumor cells.~      Eligibility:~        -  Individuals at least 18 years of age who have advanced cancers that have not responded~          or are no longer responding to standard treatments.~        -  Because the vaccine is made with yeast, people with yeast allergies will not be~          eligible.~      Design:~        -  Participants will be screened with a medical history and physical exam. Imaging studies~          will be used to examine the cancer. Heart and thyroid function tests will be conducted.~          Blood and urine samples will also be collected.~        -  Participants will receive vaccine injections every 2 weeks, for a total of seven~          visits. After seven visits, if the cancer has shrunk or stopped growing, participants~          will continue to have the vaccine about once a month.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Other tests~          will be given as directed by the study doctors. Some participants will have apheresis~          to collect additional blood cells for study.~        -  Participants will continue to receive the vaccine as long the tumor does not start~          growing again and there are no serious side effects....~   "
117365|NCT01519804|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in~     patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).~     Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on~     Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and~     platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not~     progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as~     maintenance therapy until disease progression or unacceptable toxicity occurs.~   "
117366|NCT01519791|"~     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in~     combination with Methotrexate (MTX) for inducing and sustaining clinical response in the~     treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active~     Rheumatoid Arthritis.~   "
117367|NCT01519778|"~     Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major~     cutaneous abscess or cellulitis/erysipelas.~   "
117368|NCT01519765|"~     Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,~     is a widely accepted induction agent, that has been proven safe and effective for induction~     of labor. It stimulates both cervical ripening and uterine contractions, thus making it an~     ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics~     of different administration routes and effects on uterine contractility, side effects, and~     safety. Vaginal misoprostol has been shown to be superior over oral administration however~     patients often prefer a more tolerable route. Buccal administration has already been shown~     to be as effective as vaginal misoprostol for cervical ripening and induction in both first~     trimester and second trimester abortions. There is minimal research comparing buccal versus~     vaginal for third trimester induction of labor. The investigators study is a prospective,~     double blinded, randomized control trial comparing vaginal misoprostol and buccal~     misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question~     whether buccal misoprostol is as effective as vaginal misoprostol for third trimester~     induction of labor.~   "
117369|NCT01519752|"~     The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is~     effective for the treatment of patients with moderate to severe Tinea pedis.~   "
117370|NCT01519739|"~     The purpose of this study is to evaluate the safety and performance of the MediGuide™ system~     during CRT implants.~   "
117371|NCT01519726|"~     Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively~     and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2~     years, and substantial weight loss, oral and i.v. midazolam are administered once more and~     blood samples are taken again.~   "
117372|NCT01519713|"~     This study is designed to assess the safety and immunogenicity of a single dose of~     Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~     (SP284) to support registration of the product in Japan.~      Primary Objective:~        -  To describe the seroprotection rate [% of subjects with serum bactericidal assay using~          baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y~          and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of~          age~      Secondary Objectives:~        -  To describe the safety following receipt of SP284 vaccine in subjects 2 through 55~          years of age~        -  To describe the immune responses to meningococcal antigens (serogroups A, C, Y and~          W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.~   "
117373|NCT01519700|"~     The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean~     duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast~     cancer patients.~   "
117374|NCT01519687|"~     The purpose of this study is to determine whether levotofisopam is safe and effective in the~     treatment of hyperuricemia and gout.~   "
117378|NCT01519635|"~     The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg~     (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to~     compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue~     oxygenation in patients with stage 1-2 hypertension with these effects with those of ESIDREX~     25mg (hydrochlorothiazide).~   "
117379|NCT01519622|"~     The purpose of this study is to determine the priorities of the elderly in the community~     about end-of-life decisions. To check the perception of the disease in the elderly in the~     community.~   "
117380|NCT01519609|"~     Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major~     single center has docuemted the advantage of using moviprep as bowel prep before~     colonoscopy.This randomised study was conducted to compare moviprep with the present~     standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in~     patients suspected of colorectal cancer, and to investigate number of days where patients~     need to stay home.~   "
117381|NCT01519596|"~     This is a randomized clinical trial that studies symptom-adapted physical activity~     intervention in minimizing physical function decline in older patients with acute myeloid~     leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional~     impairment and improve the quality of life in patients with AML undergoing chemotherapy.~   "
117382|NCT01519583|"~     The WalkMore study will help find out how walking interventions can help overweight/obese~     postmenopausal women with increased risk of cardiovascular disease lower their blood~     pressure.~   "
117383|NCT01519570|"~     Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain~     low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate~     the application of preventative health care, such as increasing immunization rates. A new~     care model that can increase the herpes zoster vaccination rate, as well as other~     preventative health services, is warranted. The objective of this study is to investigate if~     the functions of an EMR, in combination with a pharmacist as part of the care team, can~     improve the herpes zoster vaccination rate.~   "
117384|NCT01519557|"~     The investigators propose to recruit individuals with schizophrenia who are symptomatically~     stable and already taking medications to participate in this study. The investigators will~     recruit 90 individuals with schizophrenia and randomize them to low and high doses of~     DAR-0100A, as well as to placebo. The investigators will have them stay in the hospital for~     several weeks and receive up to 10 doses of DAR-0100A. The investigators will also test~     their cognition before and after receiving DAR-0100A to see if DAR-0100A is helpful and~     perform MRI scans before and after taking the medication to see which areas of the brain are~     activated when DAR-0100A is administered. These tests will be very important because they~     will help the investigators determine whether the D1 receptor is a good treatment target for~     schizophrenia and whether more research and resources should be devoted to finding~     medications that target this system.~      Patients with schizophrenia will be free of other medical, psychiatric and neurological~     disorders including alcohol and substance dependence, and will be able to understand the~     nature of the study and to provide informed consent.~   "
117385|NCT01519544|"~     More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to~     answer the question: Which medication is associated with better sleep at high altitude:~     temazepam or acetazolamide? The investigators hypothesis is that one medication will be~     associated with higher subjective sleep scores than the other. The study will compare the~     sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit~     to high altitude.~   "
117386|NCT01519531|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending~     multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and~     Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts~     corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed~     daily for 14 days.~   "
117387|NCT01519518|"~     The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the~     performance and subsequent outcomes of Primary percutaneous coronary intervention. This will~     be a pragmatic trial. Interventional procedures will be performed to reflect current and~     evolving standards, including predominant radial access. All patients will be treated with~     routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved~     for 'bail out' treatment only.~   "
117388|NCT01519505|"~     Public health strategy on type2 diabetes prevention in primary health care. European~     coordinated project (DE-PLAN) adapted to Catalonia (DE-PLAN-CAT). Two-step multicentre~     cohort study: cross-over period (screening) plus a follow-up period (preventive~     intervention): 12 centres, 7 working-groups, 42 units, 106 professionals). Interventions:~     Randomized non-invasive diabetes screening program by means of the FINDRISC score comparing~     with the oral glucose tolerance test results. At least one third of the screened subjects is~     expected to present high-risk criteria. They will choose 1 out of 3 interventions to modify~     lifestyle: self-acting vs. individualized or group-based educative (6-hour, 3 or 4 sessions~     program). Participants' motivation will be periodically reinforced. Follow-up will be~     focused on diabetes incidence, cardiovascular risk (HearthScore, Regicor scores),~     lifestyle-quality of life (assessed by European peer-reviewed questionnaires) and~     cost-effectiveness analysis. First-year results includes: protocol, measurement tools and~     database available, screening concluded (n=2082) and European intervention manual on type 2~     diabetes prevention started.~   "
117389|NCT01519492|"~     The purpose of the study is to determine the safety, tolerability and effectiveness of~     AFN-12520000 for in the treatment of Staphylococcal infections of the skin.~   "
117390|NCT01519479|"~     The purpose of this study is to assess the impact of palliative care consultation on quality~     of life and symptom management for patients hospitalized with acute heart failure with a~     randomized control trial at Abbott Northwestern Hospital.~   "
117391|NCT01519466|"~     The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood~     glucose meter with a built-in insulin calculator) on glucose control in people with type 1~     diabetes.~   "
117424|NCT01519037|"~     The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of~     cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the~     interaction between furosemide and cinacalcet on parathyroid hormone secretion.~   "
117392|NCT01519453|"~     Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical~     guidelines, low-income, minority children have disproportionately high morbidity and~     mortality from asthma. The National Center for Children in Poverty has strongly argued that~     effective interventions to improve asthma health disparities and reduce harm must begin in~     early childhood. Previous efficacy studies have suggested that asthma education programs can~     be effective in improving overall management of asthma for preschool children. However, for~     these promising asthma intervention strategies to have sustainable public health impact for~     low-income, minority children they must be integrated within those medical, educational and~     social structures that serve these young high risk children, such as community clinics,~     schools and day care programs. Because one of the core missions of federally-funded Head~     Start programs is to provide preventive health services and screening to their low-income~     preschool students, Head Start represents an ideal community setting for disseminating early~     asthma education. The investigators propose to draw on our established health and research~     partnership with Head Start programs in Baltimore City to test the effectiveness of this~     home-based asthma education intervention with demonstrated efficacy, when delivered in the~     context of a Head Start-wide asthma education program. The investigators further propose to~     partner with Head Start to support and evaluate adoption, maintenance and dissemination of~     new knowledge gained from this project. Specifically the investigators hypothesize that~     participants receiving the ABC intervention combined with a HS-level asthma education will~     have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with~     participants in the HS-level asthma education alone. The investigators plan to enroll of 406~     children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome~     measures include other measures of asthma morbidity (i.e., hospitalizations, ED visits, oral~     steroid bursts, school absences, and caregiver quality of life). The investigators will also~     evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge,~     motivation, and asthma management practices, as well as moderator effects, such as health~     literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head~     Start adoption and dissemination of an asthma education curriculum.~   "
117393|NCT01519440|"~     The purpose of this study is to determine whether a specific surgical technique, blunt~     compared with sharp expansion of the transverse lower uterine incision, is associated with~     risk of unintended extension of uterine incision~   "
117394|NCT01519427|"~     This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating~     patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or~     dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib~     and Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.~   "
117395|NCT01519414|"~     This randomized phase II trial studies how well tivantinib works compared to placebo in~     treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
117396|NCT01519401|"~     The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the~     metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).~      The objective of this study is to compare the effects of a long term administration of two~     EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of~     ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in~     normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to~     group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score~     evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic~     clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.~   "
117397|NCT01519388|"~     Neuromuscular disorders can be associated with swallowing dysfunction secondary to a~     dysfunction of the airway muscles involved in swallowing. The investigators have shown that~     respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular~     respiratory failure. Furthermore, although tracheostomy has been reported as impairing~     swallowing, the investigators have shown that when a tracheostomy is performed in~     neuromuscular patients, swallowing improves because it allows the patient to feed while~     ventilated.~      The investigators now want to evaluate whether non invasive ventilation may have a~     beneficial impact on swallowing by making some adjustments to ensure a good synchronisation~     between ventilation and swallowing. This could allow avoiding the necessity of a~     tracheostomy or a gastrostomy due to swallowing dysfunction and/or malnutrition in~     neuromuscular patients.~      Swallowing improvement under mechanical ventilation depends on improving the synchronisation~     between the patient and the ventilator during swallowing. For that purpose, the~     investigators developed a prototype ventilator able to temporarily suspend pressurisation~     under the patient's control so that when the patient needs to swallow under mechanical~     ventilation he may do so with an inadequate insufflation of the ventilator.~      Our objective is to to demonstrate that swallowing is more adapted and easier under nasal~     noninvasive ventilation than during spontaneous breathing in neuromuscular patients~     requiring prolonged noninvasive ventilation.~      In an open monocentric pilot study, the investigators will study 10 neuromuscular patients~     usually noninvasively ventilated. The patients will be their own control and their swallow~     will be studied during spontaneous breathing and under ventilation with the adapted~     ventilator while swallowing boluses of different volumes.~   "
117398|NCT01519375|"~     The primary objective of this cross-sectional observational real life study is to~     investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID~     associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis,~     Rheumatoid Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient~     questionnaires.~   "
117399|NCT01519362|"~     Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue~     augmentation in different parts of the body , such as face, breast , or even penis for more~     than a decade . However, there are never reports about the application of a large amount of~     PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with~     leukocytopenia. This fancy application turned out to be a disaster for the women who~     suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the~     affected tissues and temporal pain changing with the temperature and the facial expression .~   "
117400|NCT01519349|"~     The investigators are performing a gene therapy clinical trial in Becker muscular dystrophy~     (BMD) and sporadic inclusion body myositis (sIBM) patients. Both of these conditions have an~     important common feature: loss of ability to walk because of weakness of the thigh muscles.~     The investigators plan to do a gene therapy trial to deliver a gene to muscle called~     follistatin (FS344) that can build muscle size and strength. If successful, the~     investigators can increase the size of the thigh muscle and potentially prolong a patient's~     ability to walk. The gene will be carried into the muscle by a virus called adeno-associated~     virus (AAV). This virus occurs naturally in muscle and does not cause any human disease,~     setting the stage for its safe use in a clinical trial.~      Presently there is no treatment that can reverse Becker muscular dystrophy or sporadic~     inclusion body myositis. Only supportive care is currently possible.~      In this study, subjects with either of these diseases will have shots of the follistatin~     gene injected directly into thigh muscle on one (first cohort) or both legs (2nd and 3rd~     cohort). One hundred and eighty days following the gene delivery, the muscle will undergo~     biopsy to look closely at the muscle to see if the muscle fibers are bigger. Between the~     time of the gene transfer and the muscle biopsy, patients will be carefully monitored for~     any side effects of the treatment. This will include an MRI of the thigh muscle before~     treatment and at day 180 following treatment. Blood and urine tests, as well as physical~     examination will be done on the subjects during the screening visit and on days 0, 1, 2, 7,~     14, 30, 60, 90, and 180 to make sure that there are no side effects from the gene~     injections. Sutures will be removed 2 weeks post-biopsy.~      Additional blood samples will be collected at 9, 12, 18, and 24 months. Patients will be~     seen at the end of 1st and 2nd years for a physical exam, assessment of muscle strength and~     appropriate blood tests.~   "
117401|NCT01519336|"~     This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential~     drug-drug interactions between darunavir and danoprevir when administered together with~     low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to~     receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In~     Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10~     days. Anticipated time on study treatment is 20 days.~   "
117402|NCT01519323|"~     This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail~     extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy~     of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly~     diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma~     harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until~     disease progression or unacceptable toxicity occurs.~   "
117403|NCT01519310|"~     The purpose of this study is to see if intestinal bacteria plays a role in choline~     metabolism (a form of choline monitored in this study is called phosphatidylcholine, also~     known as lecithin). This study will help to determine if choline metabolism is affected by~     short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form~     of eating yogurt).~   "
117404|NCT01519297|"~     This study will compare blood vessel and hormone differences between women who have a~     history of a pregnancy complicated by preeclampsia or high blood pressure, and women who~     have a history of uncomplicated pregnancy in the last 10 years. The investigators~     hypothesize that postpartum women with history of preeclampsia will have altered blood~     vessel function and abnormal hormone levels compared with postpartum women with history of~     uncomplicated pregnancy.~      This study will take place over the course of 2 weeks. Each subject will be assessed on a~     fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood~     vessel imaging tests and fasting blood draws.~   "
117405|NCT01519284|"~     To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics,~     in comparison to placebo and entacapone.~   "
117406|NCT01519271|"~     Mild cognitive impairment, including difficulty with solving problems, planning, attention,~     or recalling information, can be a significant problem for individuals with Parkinson's~     disease. Even mild cognitive difficulties can lead to worse functioning, quality of life,~     depression, and difficulty for caregivers. Thus, ideally treatment at this stage would~     improve both cognitive symptoms and some of the other problems associated with these~     symptoms.~      Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease~     patients little is known about how best to treat it. This study is a 24-week clinical trial~     to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine)~     Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease.~     Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to~     moderate dementia in Alzheimer and Parkinson's disease patients.~   "
117407|NCT01519258|"~     Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical~     activity of the diaphragm to control the mechanical ventilator, offering inspiratory~     assistance in proportion to respiratory effort to patients who need artificial ventilatory~     support. It has been shown to improve the interaction between the patient and the mechanical~     ventilator in several clinical situations, but no previous studies have tried to use it for~     patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress~     Syndrome (ARDS). Patients with ARDS benefit form a mechanical ventilatory strategy that~     includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the~     application of such strategy frequently requires high levels of sedation. The investigators'~     hypothesis is that NAVA can be used for patients with ARDS, and that it will not be~     associated with excessive tidal volumes or elevated airway pressures.~   "
117408|NCT01519245|"~     The goal of this project is to determine whether the use of tranexamic acid, a~     clot-promoting drug, applied topically over the heart in coronary artery bypass graft~     surgery (CABG) will reduce post operative blood loss. The investigators' hypothesis is that~     the use of a tranexamic acid-containing cardiac bath prior to chest closure will result in a~     statistically significant reduction in blood loss and transfusion requirements in patients~     who undergo CABG.~   "
117409|NCT01519232|"~     Radiation-induced liver disease (RILD) is a syndrome characterized by the development of~     anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous~     studies have shown that both the volume of liver irradiated and the dose of radiation~     delivered are prominent factors for development of RILD. While use of a population-based~     normal tissue complication probability model allows investigators to limit the risk of RILD~     to a clinically acceptable level, a test that permits investigators to determine an~     individual's risk of RILD during the course of treatment may allow for individualized~     treatment modifications, either to prevent toxicity or increase efficacy.~   "
117410|NCT01519219|"~     The goal of the trial is to assess the effect of radiation treatment on liver function as~     determined by indocyanine green extraction. The long term goal is to determine if individual~     assessment of liver function using the IC-Green method, either alone or in combination with~     other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are~     superior to the probabilistic method currently in use.~   "
117411|NCT01519206|"~     The purpose of this study is to evaluate the Ulthera® System for obtaining lift and~     tightening of the cheek tissue, reduction of jowling, and improving jawline definition~     and/or submental skin laxity when increased density treatment is applied.~   "
117412|NCT01519193|"~     Street children and children of vulnerable families in conflict or former conflict regions~     are often exposed to multiple traumatic events and situations in which they are forced to~     engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo)~     aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor~     fearful experiences and positive emotions linked to violent behaviour in the past.~     Additionally, visions for the future are developed in order to foster successful~     reintegration into society.~   "
117413|NCT01519180|"~     Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even~     nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal~     motility impairement.~   "
117414|NCT01519167|"~     The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric~     population requiring non-intubated, spontaneous breathing, moderate to deep sedation~     (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30~     minutes.~   "
117425|NCT01519024|"~     Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor~     alterations and impairment in body balance due to postural misalignment. The investigators~     conducted this study to evaluate the postural control with different sensorial information~     condition in women with breast hypertrophy.~   "
117415|NCT01519154|"~     Children < 10 years of age often need deep sedation or anaesthesia to allow elective~     diagnostic magnetic resonance imaging; standard routine protocols are~        1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs~          and propofol infusion 10 mg/kg h~        2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed)~          and propofol infusion 5 mg / kg h~      both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI,~     cerebral perfusion/blood flow.~      Hypothesis:~        1. reduces recovery time compared to propofol mono sedation~        2. combination of ketamine-propofol increases incidence of Postoperative nausea and~          vomiting (PONV) compared to propofol mono sedation~        3. combination of ketamine-propofol increases global cerebral blood flow and changes~          regional distribution of cerebral perfusion compared to propofol mono sedation~   "
117416|NCT01519141|"~     This is a longitudinal observational study of HIV-infected patients and HIV-negative control~     patients that is being conducted to learn more about immunologic factors, inflammation, and~     cardiovascular risk in patients with HIV infection or in patients with autoimmune disease.~     The investigators plan to obtain measurement of carotid artery intima media thickness (IMT)~     using high resolution ultrasound as a noninvasive means for tracking atherosclerotic~     progression. The investigators will also measure lipid and lipoprotein levels, inflammatory~     markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic~     lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly~     collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell~     turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4~     count and HIV viral load measured in addition. Patients will undergo detailed clinical~     history including HIV disease, specific HIV medications, comorbid conditions, and health~     related behaviors. Physical exam and measurements will be obtained to assess for the~     presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw,~     and interview at 4-12 month intervals for the next 3 years.~      Patients will also go assessment of endothelial function, endothelial progenitor cells,~     arterial stiffness as measured using pulse wave tonometry.~      To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV~     positive and negative patients with cardiac disease, the investigators will use 48-hour~     Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history~     of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery~     hypertension for the presence of cardiac arrhythmia.~      The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography)~     will be used to detect and quantify inflammation in the body.~   "
117417|NCT01519128|"~     The purpose of this study is to investigate the effect of steady-state (constant~     concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what~     the body does to the medication) of digoxin.~   "
117418|NCT01519115|"~     Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization~     has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training~     cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to~     be effective in reducing neck pain, restoring cervical spinal function and mobility in many~     types of cervical spine dysfunction. However, the training of stabilizers has not been~     studied in individuals undergoing cervical spinal surgery, even though these individuals~     often have problems with residual pain and weakness after the surgery.~      Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes~     between an early PT intervention and usual care in patients who have undergone anterior~     cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved~     with early PT intervention.~      Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3)~     research design. The patients following ACF surgery will be randomly assigned in one of the~     two treatment groups: usual care and early intervention. Three outcome measures will be~     collected pre-operative for baseline, and then at 6-week and 12-week post-operative~     follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the~     cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability~     associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3)~     neck pain level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks,~     the global rate of change (GROC) scale will be obtained to determine the patient's~     perception of overall improvement as a result of surgery. The investigator performing the~     outcome measures will be blinded to group assignment, and therefore will not participate in~     treatment. After randomization, the usual care group will receive only one visit of PT for~     post-operative instruction. The early intervention group will receive verbal and written~     instructions for posture and training cervical spine stabilizers in addition to the usual~     care. The early intervention group also will be asked to perform these exercises at home and~     keep a log of the exercise.~      Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the~     differences in the CCF strength and the NDI scores between groups and at the three different~     time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will~     be used to compare the differences in the NPRS and GROC data over time and between groups.~   "
117419|NCT01519102|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main goal of this project is to assess whether a dual-hormone closed-loop strategy would~     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)~     without a significant degradation in post-meal glucose control.~      Each patient will be admitted twice to a clinical research facility. In one visit, patients~     will eat a morning meal accompanied with a matching insulin bolus (depending on the~     carbohydrate content of the meal) and glucose levels will be subsequently regulated using~     dual-hormone closed-loop system. In the other visit, patients will eat the same meal but~     will inject only a partial insulin bolus (not depending on carbohydrate content of the meal)~     and the remaining needed insulin will be delivered based on glucose sensor excursions as~     part of closed-loop operation. If post-meal glucose levels were indifferent between the two~     visits, then this would suggest that carbohydrate counting may not be necessary during~     closed-loop operation as the closed-loop system will give any remaining insulin needed to~     cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study.~   "
117420|NCT01519089|"~     The main objective of this study is to evaluate the long term safety of CP-690,550 in~     patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis.~     This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and~     10 mg BID) after 16 weeks of treatment.~   "
117421|NCT01519076|"~     This study is a prospective trial wherein each included subject will receive the~     experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of~     ten adult male or female patients who meet the inclusion and exclusion criteria and informed~     consent has been obtained. Subjects presenting in the emergency department with acute~     ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the~     study.~   "
117422|NCT01519063|"~     The purpose of this study is to evaluate the combined effects of the study medications~     naltrexone and memantine on alcohol drinking behaviors. Participants will be randomized to~     receive a combination of these medications over a one week period and then participate in a~     laboratory session. During this session, participants are given an initial drink of alcohol~     followed by the choice to drink up to 12 more drinks over a three-hour period. These~     medications are hypothesized to reduce craving and number of drinks consumed prior to and~     after exposure to the initial drink of alcohol and during the three hour drinking period.~   "
117426|NCT01519011|"~     The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine~     when administered once daily as two 150-mg tablets, including the effect of food, and to~     evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg~     tablets relative to three 100-mg tablets.~   "
117427|NCT01518998|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan~   "
117428|NCT01518985|"~     This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial~     enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the~     endothelial dysfunction induced by a single cigarette.~   "
117429|NCT01518972|"~     The purpose of this study is to determine whether the drug prazosin is effective for the~     treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).~   "
117430|NCT01518959|"~     Recent data have shown that the inadequate vitamin D status plays a role in the~     manifestation of the haematologic tumors and serum vitamin D level has a prognostic role~     also as it determines the tumor mortality. But data have not proved a causal relationship~     between the inadequate vitamin D status and the unfavourable outcomes so far. It is also~     still unknown, whether the normalization of vitamin D status in patient with vitamin D~     inadequacy is able to improve the prognosis and survival.~      In this study the investigators examine the role of the adequate vitamin D substitution in~     the improvement of the outcomes of haematologic disorders.~   "
117431|NCT01518946|"~     The purpose of this study is to determine whether midodrine works against the symptoms of~     orthostatic hypotension caused by being on a tilt table.~   "
117432|NCT01518933|"~     Hepatitis C virus (HCV)-related liver disease is the most common indication for liver~     transplantation (LT). However, LT does not cure the infection, and therapeutic strategies~     resulted in very limited efficacy and tolerability in LT recipients. In view of its~     postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV~     recurrent patients after liver transplantation.~   "
117433|NCT01518920|"~     The objective of this study is to examine the safety, tolerability, and effects on hearing~     thresholds of two single doses of PF-04958242 and placebo in subjects with age-related~     hearing loss.~   "
117434|NCT01518907|"~     This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of~     AA4500 at increasing doses and concentrations in the treatment of adult women with~     cellulite.~   "
117435|NCT01518894|"~     To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242~     administered orally to psychiatrically stable subjects with schizophrenia receiving~     antipsychotic and adjunctive medication.~   "
117436|NCT01518881|"~     This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human,~     single-ascending dose study with additional multiple-ascending dose cohorts in healthy male~     and female volunteers.~   "
117437|NCT01518855|"~     The primary objective of this study is to investigate incremental cost effectiveness of~     Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of~     essential hypertensive patients.~      To investigate incremental cost effectiveness, primary variables are mean treatment cost and~     achievement rate to target blood pressure level at the end of double-blind treatment period.~   "
117438|NCT01518842|"~     This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem~     cells in patients with ischemic retinopathy.~   "
117439|NCT01518829|"~     the value of serum procalcitonin in differentiation between bacterial infection and non~     infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.~   "
117440|NCT01518816|"~     The aim of this study is to detect the association between maternal serum antioxidant level~     and preterm labor.~   "
117441|NCT01518803|"~     Obesity has a major impact on the development of cardiovascular disease and other related~     conditions and it is of particular concern in children. The prevalence of childhood~     overweight and obesity in Spain is among the highest in the European continent. Childhood~     obesity has been associated with diseases that were thought to apply only to adults, such as~     the metabolic syndrome. Insulin resistance is the most important risk factor in subjects~     with severe obesity, which together with visceral obesity, exacerbates postprandial~     triglyceridemia, increasing cardiovascular risk.~      In this context, the investigators hypothesize that the postprandial lipid metabolism is~     also impaired in obese pre-adolescents, as it is in obese adults. This includes not only~     exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers.~     In addition, the investigators hypothesize that the lipid and protein composition of~     postprandial chylomicrons and chylomicron remnants are also altered in obese children when~     compared with their normal-weight counterparts, and that these postprandial lipoproteins~     induce foam cell formation differently. The investigators also believe that a~     Mediterranean-style meal can help to normalize the altered postprandial lipid metabolism in~     obese adolescents.~   "
117442|NCT01518790|"~     The investigators propose to conduct a prospective study of a widely used bowel preparation~     regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a~     colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1~     Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the~     cleanout, assess tolerability and acceptance of the regimen, determine an appropriate~     duration to complete the regimen and assess for any electrolyte changes or side effects.~   "
117443|NCT01518777|"~     This is a pilot study to see whether cardiac imaging can be performed using half the~     standard dose of radioisotope.~   "
117456|NCT01518608|"~     Induction of anesthesia:~      After 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil~     (0,10,20,30,40,50 or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will~     be administered over 15 sec. Laryngoscopy will be performed 40 s. after injection of~     rocuronium, with the goal being to have the endotracheal tube passed through the patients~     vocal cords and the cuff inflated within the following 15 s . The investigator performing~     the tracheal intubation is blinded to the dose of alfentanil administered.~      Blood samples:~      As part of the study efficacy, blood samples, will be collected prior to induction and 30~     s., 1 min. 3 min. and 5 min postintubation to determine blood concentrations of alfentanil~     and catecholamines.~   "
117444|NCT01518764|"~     Rationale:~      Epidemiological studies have shown that consumption of alcoholic beverages, red wine in~     particular, is associated with less cardiovascular mortality. In addition, there are~     reported beneficial effects of red wine on components of the metabolic syndrome, arguably~     the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic.~     Beneficial effects have also been reported with other polyphenol-rich food stuff, such as~     cocoa and green tea and points to a beneficial effect which does not seem to be dependent on~     the alcohol content of red wine. Experimental studies with mixed or separate Red Wine~     Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic~     parameters associated with obesity. Most research has focused on resveratrol, a specific~     polyphenol components which is quite specific to red wine and has, at least in animal~     studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial~     function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the~     same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce~      Objective:~      To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function~     (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.~      Study design:~      Randomized controlled trial (double blind).~      Study population:~      Obese (BMI >30); n=30, men or women, aged 18-60 years.~      Intervention:~      Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.~   "
117445|NCT01518751|"~     Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common~     amongst parkinson patients. The overall aim of this study is to examine blood pressure~     regulation and esophageal motility and gastric emptying in Parkinson`s disease (PD)~     patients.~      The investigators hypothesize that - compared to age-matched controls - PD patients display~     an altered regulation of blood pressure, altered gastroesophageal motility, and delayed~     gastric emptying. These symptoms occur already early in the disease process, but aggravate~     with progression of the disease.~      The investigators will perform a 7-day blood pressure measurement, measurement of central~     blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to~     assess orthostatic function, high resolution manometry assessments during swallowing acts,~     and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each~     Hoehn&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be~     interpreted in relation to the severity of PD motor symptoms.~      The investigators anticipate that blood pressure dysregulation and gastroesophageal motility~     disturbances will be present only in PD subjects, but not in matched controls without~     neurological disorders and without any extrapyramidal motor signs. Furthermore, the~     investigators expect to find an association between motor impairment and the severity of~     these autonomic symptoms, however, that according to the Braak staging, subtle disturbances~     must already be present in the early stages of PD.~   "
117446|NCT01518738|"~     The purpose of this study is to understand whether attention training is effective in~     moderating mind wandering.~   "
117447|NCT01518725|"~     The purpose of this study is to evaluate the change in vitamin D status with the change in~     muscular strength and muscular power in highly trained athletes over a 9-month study period.~     The investigators hypothesize that the greatest muscular strength and power gains will be~     demonstrated in the athletes who achieve and maintain a 25(OH)-D > 50 ng/mL (but < 100~     ng/mL) over the 6 month study duration.~      This hypothesis will be tested by carrying out the following specific aims: Aim 1. to~     determine the extent to which increasing serum 25(OH)D to > 50 ng/mL is associated with~     improved muscular power by assessing specific performance measures (e.g. Vertical Jump Test~     and Wingate test) relative to lean body mass; and Aim 2. to examine the correlation between~     vitamin D status and muscular power over time.~   "
117448|NCT01518712|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
117449|NCT01518699|"~     The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in~     Healthy Volunteers.~   "
117450|NCT01518686|"~     The purpose of this study is to determine normal values of the visual field (VF), corrected~     for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic~     perimetry (SKP).~   "
117451|NCT01518673|"~     Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays.~     Pediatric patients are known to be very radiosensitive with respect to radiation induced~     cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most~     important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can~     be detected. The technique will be applied in a multicenter setting for evaluation of~     X-effects induced by a computed tomography examination in a population of pediatric~     patients. To this end a blood sample will be taken from the patients before and after the~     examination.~   "
117452|NCT01518660|"~     The purpose of this study is to investigate underlying mechanisms possibly explaining the~     beneficial effects of progressive resistance training for people with multiple sclerosis.~   "
117453|NCT01518647|"~     The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in~     patients with long lasting health problems with no known medical explanation, defined as~     multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of~     treatment, a 9-session group therapy and a 1-day workshop followed by an individual~     consultation, and both are compared to standard treatment, which is one single advisory~     consultation. The study includes 180 patients.~   "
117454|NCT01518634|"~     The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in~     patients with longlasting health problems with no known medical explanation, defined as~     multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS~     have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing~     both pain and other symptoms of bodily distress for patients with BDS. Control conditions~     are pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13~     weeks, i.e. after 10 weeks of 25-75 mg study drug.~   "
117455|NCT01518621|"~     To determine if erlotinib given orally along with concurrent whole brain irradiation in lung~     cancer patients with brain metastases improves median overall survival and enhances local~     control compared to those treated with WBRT alone, without significantly increasing the risk~     of side effects or lowering quality of life.~   "
117457|NCT01518595|"~     The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is~     the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with~     hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication~     of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up~     to date, the only therapeutic option is liver transplantation. The study hypothesis is that~     administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary~     syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS~     according to the ERS task force criteria will be included in this block randomized,~     double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with~     placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8~     weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary~     endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration~     of the study is 2 years.~   "
117458|NCT01518582|"~     This is a prospective clinical study to assess the performance of the prosthesis according~     to a composite success criterion. The clinical and functional results and the patient's~     quality of life up to 24 months of follow-up will also be recorded.~      Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.~   "
117459|NCT01518569|"~     The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin~     inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response~     in cardiac surgery with CPB.~      Serial measurements and analysis of several inflammatory cytokines (bactericidal~     permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers~     of cardiac injury, renal impairment and oxygenation profile will be performed to determine~     ulinastatin's efficacy.~   "
117460|NCT01518556|"~     The purpose of this study is to determine whether idarubicin dose intensification is safe~     and effective as a remission induction therapy for acute myeloid leukemia.~   "
117461|NCT01518543|"~     There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of~     them.~      The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by~     Baciu and Filibiu (1979). In the technique, they did take the dowel out before turning it.~     The healing process takes place between surfaces of spongious bone. They showed excellent~     results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994)~     combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5~     weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients~     (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason~     may be the circular bone gap of at least 1 mm left by the saw blade.~      A new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow~     the dowel to be turned in situ without leaving in position. The staple is introduced into~     the joint line and will compress the dowel surfaces against the surrounding bone.~     Instruments are available to ensure the correct position and length of the dowel, and to~     rotate it in situ before the special wedge staple is introduced.~      Dr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series~     with 83 arthrodesis. The purpose of this study is now to collect and publish data from~     several centers, several users.~      The objective of this study is to obtain the percentage of healing 3 months after an~     implantation of the staple ASTUS.~   "
117462|NCT01518530|"~     The study is intended to examine the safety and efficacy of computerized mobilization of the~     neck for the treatment of patients with chronic neck pain. This is a third continuation~     study aimed at examining the Occiflex Robotic System. This time we will be studying tailored~     or personalized three dimensional movement of the neck.~   "
117463|NCT01518517|"~     Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by~     toxicities including hypersensitivity. Clinical allergy is associated with inactivation of~     asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any~     clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics,~     tolerability and maintain circulating asparaginase activity due to the protective barrier of~     the erythrocyte membrane.~      This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination~     with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without~     known hypersensitivity to L-asparaginase.~   "
117464|NCT01518504|"~     The purpose of this study is to investigate the effect of thoracic spine joint manipulation~     versus a sham intervention on active and passive shoulder flexion (elevation), external~     rotation, and internal rotation range of motion.~   "
117465|NCT01518491|"~     The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction~     with serial wound debridement and irrigation on the healing rates of open traumatic~     orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation~     alone in patients receiving negative pressure wound therapy/vacuum assisted closure~     (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.~   "
117466|NCT01518478|"~     A new flu vaccine which is injected into the skin instead of into the muscle has recently~     been approved by the Food and Drug Administration for vaccination of the general population~     including patients with atopic dermatitis (AD). This new vaccine has been shown to work as~     well as the vaccine which is injected into muscle when tested in people without atopic~     dermatitis. The primary endpoint of the study is to estimate the variance of the log fold~     change from baseline in HAI antibody titers for non-atopic controls and participants with~     atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration~     of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.~   "
117467|NCT01518465|"~     This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and~     low-dose dexamethasone together works in treating patients with previously untreated~     multiple myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from~     forming in patients being treated with lenalidomide and dexamethasone for multiple myeloma.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different~     ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may~     be an effective treatment for multiple myeloma~   "
117468|NCT01518452|"~     The main aim of this prospective interventional study is to compare quantitative EEG~     findings and cognitive and neuropsychological test results before and after training with~     the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e.~     ages 5-6 years. The investigators hypothesize that the children in the study may respond~     positively to the computerized training and improve working memory, but probably to~     different degrees depending on the underlying neurological condition. The investigators also~     hypothesize that training may benefit additional executive functions.~   "
117469|NCT01518439|"~     Inefficient cough is responsible of respiratory complications in neuromuscular patients~     which can lead to hospitalisation and can be life threatening. Techniques enhancing cough~     efficiency are successful in improving the clearance of bronchial secretions and help non~     invasive ventilation efficiency especially in case of acute respiratory failure. Combining~     mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency.~     Therefore the investigators want to compare cough efficiency under different techniques of~     instrumental and manual of cough assistance in order to determine the best combination to~     optimize cough flow.~   "
117470|NCT01518426|"~     The purpose of this study is to compare three different techniques of EEG recording for~     extraction of P300 Evoked Related Potentials (ERPs).~   "
117471|NCT01518413|"~     The purpose of this study is to determine the safest and most effective oral dose~     combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e.~     relapsed or refractory.~   "
117472|NCT01518400|"~     The purpose of this study is to develop a mechanism for utilizing the comprehensive clinical~     database of childhood cancer survivors at Childrens Hospital Los Angeles (CHLA) for research~     purposes. Using clinical information obtained from follow-up visits of childhood cancer~     survivors, the database will focus on interventions to improve health status and~     health-related quality of life in childhood cancer survivors. This study allows for~     establishment and analyses of a research database for LIFE survivors by the investigators~     listed herein. Over the last three decades, there has been marked improvement in survival~     following childhood cancer, with 5-year survival rates now approaching 80%. However, the use~     of cancer therapy at an early age can result in complications that may not be apparent until~     years later as the child matures. These resulting complications, called late effects, are~     principally related to the specific therapy employed and the age of the child at the time~     the therapy was administered. Late effects may affect virtually every body system and~     substantially impair quality of life. As many as two-thirds of childhood cancer survivors~     develop at least one late effect as a result of treatment, and approximately one-third have~     a late effect classified as severe or life threatening.~   "
117473|NCT01518387|"~     The purpose of this study is to assess the effect on reduction of serum phosphate and the~     safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing~     continuous ambulatory peritoneal dialysis.~   "
117474|NCT01518374|"~     This protocol is designed to standardize imaging studies using florbetapir F 18 PET to~     provide information on amyloid burden in subjects participating in other studies (companion~     protocol) such as longitudinal studies of aging and studies of biomarkers for~     neurodegenerative diseases.~   "
117475|NCT01518348|"~     To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E.~     Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin,~     Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric~     subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical~     history.~   "
117476|NCT01518335|"~     This research study hopes to determine whether or not platelet rich plasma therapy improves~     healing time of moderate to severe ankle sprain in comparison to standard of care therapy.~   "
117477|NCT01518322|"~     Overall Aim:~      To better understand the diagnostic process for prolonged respiratory events and determine~     the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology.~      Study Objectives:~      The specific objectives of this study are to:~        -  Determine the frequency of ICS prescription for the treatment of non-specific lower~          respiratory symptoms.~        -  Determine the frequency of asthma diagnosis as an etiology for the non-specific lower~          respiratory symptoms.~        -  Explore the value of FeNO in identifying asthma as the etiology of the non-specific~          lower respiratory symptoms.~      Number of Subjects:~      It is anticipated that up to approximately 3,000 patients will be asked to complete the~     brief screening questionnaire that will be used to identify up to approximately 280 eligible~     patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6~     week study enrollment period.~      Reference Product: NIOX MINO®~      Duration of the participants involvement in the investigation: Single Visit~      Performance assessments:~      Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO®~     device according to Instructions for NO measurements which will be provided to each~     Investigative site prior to patient enrollment.~      Safety Assessments:~      The Investigator is responsible for the detection, reporting, and documentation of events~     meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this~     clinical investigation plan from the time of informed consent/assent and during the study~     period.~      Criteria for Evaluation:~      The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS~     will be explored by correlation, measures of concordance and logistic modeling.~   "
117478|NCT01518309|"~     This is an open-label extension study to assess the long-term safety and tolerability of~     pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).~   "
117479|NCT01518296|"~     Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of~     this disorder varies and includes conservative and interventional treatment.~      Pelvic organs prolapse grading has an important roll in determining the appropriate~     treatment. Developments in this field has led to the development of an agreed method to rate~     the degree of pelvic organs prolapse (POPQ).~      The roll of Urodynamic test is to assess whether there is urinary incontinence and~     underlying cause.~      In Richard C. et al publication, that presented the Pelvic Organ Prolapse Quantification~     (POPQ) method for the first time, there was no reference to the urinary bladder state (full~     or empty) during the examination, hence the investigators are asking to conduct a~     prospective study in order to evaluate the degree of pelvic organs prolapse according to~     POPQ method during urodynamic examination, with a full and empty urinary bladder.~   "
117480|NCT01518283|"~     This is a multicenter open label non randomized phase II clinical trial of Weekly~     Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated~     with Docetaxel.~      The purpose of this study is to evaluate the activity of the weekly administration of~     cabazitaxel as time to progression by PSA at week 12.~   "
117481|NCT01518270|"~     This study will asses epidemiologic changes in eyelash characteristics with increasing age.~   "
117482|NCT01518257|"~     This study will evaluate the efficacy and safety of a single intra-articular (IA) injection~     of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee~     pain.~   "
117486|NCT01518205|"~     Diabetic foot (DF) is a common, severe and costly complication of diabetes. DF is underlied~     by neuropathy, atherosclerosis of distal arteries and infection, which result in tissue~     ulcers and necrosis. Alterations in microcirculatory function and in blood rheology may~     concur in causing tissue damage.~      In recent years there has been accumulating evidence that LDL apheresis (LA) does not only~     reduce cholesterol but also has a series of pleiotropic effects that improve the~     microcirculation, increasing peripheral tissue perfusion.~      HADIF is a randomized, multicentric, prospective clinical study aimed at assessing the~     effect of LDL apheresis treatment in association with traditional therapy for ulcers, in~     patients with an ischemic diabetic foot ulcer (class I and II Texas Wound Classification~     System)and peripheral vasculopathy not susceptible to revascularization. A total of 132~     patients will be enrolled. Participants will be centrally randomized to receive traditional~     therapy alone (TT) or in association with LA. TT includes standard medication of ulcers,~     antiaggregant therapy and statins. LA will be performed with HELP system, for a total of 10~     sessions in 9 weeks. The primary end-point of the study is ulcer healing; secondary~     endpoints include improvements of peripheral oxygenation, resolution of pain, reduction of~     circulating inflammatory markers, cardiovascular events during one year's follow-up.~      This clinical Study has been approved by local EC on 25 may 2011 (Study number 1953).~      TO BE NOTED: since diabetic patients in our Diabetic-Foot UNIT often presented foot ulcers~     more severe than class II Texas, a formal amendment has been submitted to EC for recruiting~     patients with diabetic foot ulcer of class III Texas. The amendment was already approved on~     5 may 2012.~   "
117487|NCT01518192|"~     Background:~        -  While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe~          as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult~          patients with erythema migrans has been assessed only in the USA where the causative~          agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main~          etiologic agents are B. afzelii and B. garinii.~        -  Controversy exists over the significance and even the existence of post-Lyme disease~          symptoms because of the high rate of similar background symptoms in the general~          population.~      Purpose:~      The two main purposes of this European, prospective clinical trial in which doxycycline and~     cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and~     which included a control group to address the significance of post-Lyme disease symptoms~     are:~        -  To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the~          treatment of erythema migrans using clinical and bacteriological criteria~          (noninferiority testing approach), and~        -  to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM~          with antibiotics and the frequency of similar symptoms in control subjects without Lyme~          disease.~   "
117488|NCT01518179|"~     Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be~     characterized by pain, stiffness, swelling, and decreased range of motion (hand and~     fingers), and grip strength.~      Compression gloves are used to enhance rehabilitation after various clinical conditions and~     injuries. However, there are no reports on the effect of compression gloves following Distal~     Radius Fracture (DRF).~      This study aims to assess the incremental effect of wearing Made-to-Measure Compression~     Gloves on rehabilitation following DRF.~      Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up~     and treatment will enhance rehabilitation, when compared with routine follow up and~     treatment, in patients following Distal Radius Fracture.~      ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal~     Radius Fractures):~      S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of~     lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of~     both ulna and radius: lower end (S52.6), shafts (S52.4).~      S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)~   "
117489|NCT01518166|"~     The trial is conducted in Europe. The aim of the trial is to investigate if there is any~     drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril~     (Zestril®), griseofulvin and digoxin (Lanoxin®).~   "
117490|NCT01518153|"~     The goal of this clinical research study is to learn what dose of a kind of immune cell~     called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell~     transplant has the best results. The safety of this treatment will also be studied. This~     will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple~     myeloma. These results are measured as helping to control the disease without severe~     graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues~     of the recipient's body.~      Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:~        -  Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells,~          which may cause the cancer cells to die.~        -  Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.~        -  Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of~          the transplant and graft-vs-host disease (GvHD).~      The donor infusion of T-cells is designed to help restore the immune system after the~     transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer~     coming back.~   "
117491|NCT01518140|"~     The goal of this clinical research study is to learn if 3 breathing devices reduce feeling~     short of breath in cancer patients. Researchers also want to learn if these devices can help~     to control shortness of breath.~   "
117492|NCT01518127|"~     The purpose of this study is to evaluate the behavior of intravitreal injection of of~     autologous bone marrow stem cells in patients with age related macular degeneration.~   "
117493|NCT01518114|"~     Exercise training (ET) is highly beneficial in heart failure patients and has been suggested~     to confer significant symptomatic and functional improvements in patients with diastolic~     dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a~     structured ET program in symptomatic HCM patients.~   "
117508|NCT01517919|"~     This study will systematically evaluate a training program in state-of-the-art behavioral~     change approaches and facilitation skills for peer leaders and a peer-led diabetes~     self-management support program designed to be conducted in community and clinic-based~     settings on an ongoing basis.~   "
117558|NCT01516307|"~     The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in~     combination with low dose cyclophosphamide, in post-treated metastatic breast cancer~     subjects with stable disease or response to treatment.~   "
117494|NCT01518101|"~     Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or~     analogs, which rely on the gastrointestinal hormones that are part of the incretin system~     for the treatment of T2DM, provide a therapeutic alternative to common oral~     antihyperglycemic agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and~     DPP-4 inhibitor medications are effective, there are differences between these products,~     including method of administration (injectable versus oral). Previous studies have shown~     that patients prefer additional oral agents over injectable agents because of fear of~     injections and the desire to avoid them. Patient preference is both clinically and~     financially important, as it can have long-term implications in terms of patients'~     motivation and insight into their disease state and its treatment, which might have a direct~     impact on the patient's compliance and treatment adherence. The aim of the current study is~     to evaluate the proportion of T2DM patients preferring oral anti-diabetic treatment with~     vildagliptin + metformin versus an injectable anti-diabetic treatment with liraglutide after~     4 weeks of treatment with each medication.~   "
117495|NCT01518088|"~     The purpose of the study is to examine how a dietary fiber affects metabolism in healthy~     overweight and obese adults. The fiber will be added to foods that participants will consume~     for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one~     period, and 30 g per day in the other. In another three-week period, they will consume the~     same foods, but with no fiber added. Major outcomes will include fermentability of the~     fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria.~     The caloric value of the fiber will be determined and metabolic measures related to blood~     glucose control and inflammation will also be taken.~   "
117496|NCT01518075|"~     In the investigators' knowledge there are no data about the impact of non invasive~     mechanical ventilation on the breathing-swallowing interaction.~      Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive~     Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute~     exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)~   "
117497|NCT01518062|"~     This trial is conducted in Europe. The aim of this trial is to assess whether increasing~     doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and~     improve final height. This trial has two trial periods, a main period of 4 years and an~     extension period until final height is reached.~   "
117498|NCT01518049|"~     The aim of this study is to develop a scale to measure the severity of depression with~     psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential~     biomarkers (substances in the blood) which can aid in the detection of psychotic depression.~      Main hypothesis: A clinically valid rating scale measuring the severity of psychotic~     depression can be developed.~   "
117499|NCT01518036|"~     This trial is conducted in Europe. The aim of this trial is to study the dose-response~     relationship and effect of somatropin (Norditropin®) on final height in girls with Turner~     Syndrome.~   "
117500|NCT01518023|"~     There is evidence that gastrointestinal operations for non weight-losing purposes are~     beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to~     gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for~     colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose~     and hemoglobin A1c concentration.~   "
117501|NCT01518010|"~     This research project aims to find out if a multiplayer online video game can provide~     therapeutic benefit for people who have survived a brain injury.~      Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of~     online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008).~     These positive emotional effects may enhance cognitive rehabilitation, because the cognitive~     and emotional sides of rehabilitation are connected (Mateer, 2005).~      The hypothesis is thus: that playing multiplayer online games can be a useful form of~     cognitive rehabilitation for brain-injured people.~      This research will identify whether or not multi-player online video games may be used as a~     complementary therapeutic tool. A further aim is to develop guidelines which would help~     others considering the use of video games for cognitive rehabilitation.~   "
117502|NCT01517997|"~     In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be~     randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study~     arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a~     paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES)~     study arm will undergo primary stenting using drug-eluting stent(s). The study's primary~     endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will~     include the immediate technical success,6-month primary patency, target lesion~     revascularization and limb salvage and complication rates.~   "
117503|NCT01517984|"~     The study will compare how well transplanted kidneys work and the response of people's~     immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this~     research study will evaluate whether reducing immunosuppression can decrease some of these~     side effects while still preventing rejection of the kidney.~   "
117504|NCT01517971|"~     This research trial studies biomarkers in predicting the risk of cancer returning after~     surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying~     samples of tumor tissue from patients with cancer in the laboratory may help doctors~     identify and learn more about biomarkers related to cancer and predict how well patients~     will respond to treatment.~   "
117505|NCT01517958|"~     The investigators hypothesize that ultrasonography of the newborn lung can be used as an~     effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of~     respiratory distress.~   "
117506|NCT01517945|"~     The purpose of this study is to customize and personalize an existing computer-based~     intervention program in order to help breast cancer survivors cope with fears of cancer~     recurrence.~   "
117507|NCT01517932|"~     Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for~     short-term postoperative sedation and analgesia.It can also reduce the stress response~     without respiratory depression.~      In this prospective, randomized, double-blind, placebo-controlled study，we gave~     dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of~     dexmedetomidine on stress response and postoperative analgesia in patients undergoing~     thoracotomy during anesthesia recovery period.~   "
117509|NCT01517906|"~     The purpose of this research study is to test a new type of counseling developed to decrease~     symptoms of anorexia nervosa and bulimia nervosa and improve health and well-being in women~     with these eating disorders. At this time, the most effective form of treatment for anorexia~     nervosa and bulimia nervosa is cognitive behavioral therapy. However, this form of treatment~     leads to a complete absence of symptoms in only about 50% of persons completing the~     treatment program. In this study we will test the effectiveness of a new form of counseling~     that focuses on identifying and building personal strengths and positive views of the self~     as the means to decrease eating disorder symptoms and improve health. This study will~     involve 150 women between the ages of 18 and 35 years who currently have symptoms of~     anorexia nervosa or bulimia nervosa. To participate in this study, women must also be: 1)~     not pregnant, 2) without any other diagnosable mental disorder, 3) not currently taking~     medications for their eating disorder or other mental disorder symptoms, 4) not ill enough~     to require inpatient treatment for their eating disorder and 5) willing to refrain from~     seeking other treatment for their eating disorder for the duration of this study. Each~     participant will participate in a 20-week treatment program that includes nutritional~     counseling and medical care. Both of these forms of treatment are considered by the American~     Psychiatric Association to be essential parts of treatment for eating disorders and have~     been found help to reduce symptoms. In addition, participants will receive one of two types~     of counseling:~        1. Experimental counseling that focuses on building strengths and positive self-views~        2. Standard counseling that helps the participant identify and solve problems that are~          believed to contribute to their eating disorder symptoms.~      The type of counseling that a participant receives will be determined randomly. To determine~     whether the experimental counseling is effective, eating disorder symptoms, psychological~     and functional health will be measured before the treatment begins and three times after the~     treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of~     this research study are expected to contribute to the development of effective interventions~     to decrease eating disorder symptoms, and increase health and well-being in women with~     anorexia nervosa and bulimia nervosa.~   "
117510|NCT01517893|"~     The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical~     trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new~     treatment for vitiligo. The aims of this placebo-controlled study seek to determine the~     safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male~     patients with generalized vitiligo. Additionally, the investigators will collect blood to~     examine the effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.~   "
117511|NCT01517880|"~     GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic~     myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA).~   "
117512|NCT01517867|"~     The purpose of this study is to compare the effectiveness of two parenting programs in a~     mental health clinic serving young children with behavior problems.~   "
117513|NCT01517854|"~     The investigators propose the first prospective, double blind, randomized controlled trial~     of treatment for pulmonary arterial hypertension (PAH) related to underlying portal~     hypertension. Specifically the investigators will evaluate the potential efficacy and safety~     of sildenafil (Revatio) in a 16 week blinded, multicentre study.~   "
117514|NCT01517841|"~     The purpose of this study is to understand what prevents chronic kidney disease patients~     from making a timely decision about dialysis modality options. This understanding will allow~     us to develop and implement interventions to assist patients in this turning point so that~     they can make the right decision for them in a timely enough manner so that each patient can~     start dialysis in the safest and best way for them. 200 later stage chronic kidney disease~     patients (20% or less of kidney function remaining) will be asked to participate in the~     study with the goal of having 150 patients participate in the study.~      Hypotheses:~        1. 50 % of patients will have made a modality decision when interviewed and patients in~          the action stage of behavior will be more likely to make a modality selection than~          patients in earlier stages of behavior change. Barriers to modality selection will act~          at several levels including patient, provider and health system level and will vary by~          behavioral stage of change~        2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of~          CKD, education, and income will likely be barriers to home dialysis choice.~   "
117515|NCT01517828|"~     Anesthesia is rarely used to intubate newborns in delivery room because of the very~     difficulty of accessing veins. The investigators hypothesized that intranasal administration~     of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used~     during neonates' intubation. They are also used intranasally in the absence of venous~     access-In a pilot study the investigators have demonstrated that sedation with Midazolam was~     effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4~     (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.~      The investigators hypothesized that intranasal ketamine would increase procedure~     effectiveness from 67 to 90%.~        -  Main objective: To compare newborns sedation quality as they are sedated either by~          intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.~        -  Secondary Objectives: To compare intubation quality, hemodynamic and respiratory~          tolerance, and neurological outcomeat 2 years within the two groups.~   "
117516|NCT01517815|"~     Overweight patients are susceptible to develop acute complications when they are admitted in~     an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure~     ('shock) and is associated with 35-50% mortality. One of the key issue to cure infection is~     to administer antibiotics. However, under dosing antibiotic is one of the main reason that~     explain treatment failure. There are very few data concerning particularities of antibiotic~     dosing in critically ill, overweight, patients. The aim of the present study is to describe~     the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both~     overweight and non overweight critically ill patients presenting a septic shock. The~     investigators hypothesis is that usual dose for those antibiotic may be accurate in non~     overweight patients but is not in overweight patients.~   "
117517|NCT01517802|"~     The purpose of this study is to collect follow-up safety data from participants in completed~     abiraterone acetate studies for a maximum duration of 6 years.~   "
117518|NCT01517789|"~     Visual morbidity (visual acuity and/or visual field deficit) must be taken into account~     during neurosurgical procedures for lesions near the optical pathways. Part of this~     morbidity is due to surgical manipulation. There is no validated tool for intraoperative~     visual monitoring and few publications have studied this issue.~      In a preliminary work based on analysis of these publications, we defined technical,~     anaesthetic and analytical parameters in order to optimise intraoperative visual evoked~     potentials monitoring. These parameters are special devices used for transpalpebral~     stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and~     pertinent analysis criteria of visual evoked potential (VEP). We suppose that these~     improvements will increase reliability of intraoperative VEP.~   "
117530|NCT01517633|"~     The purpose of this study is to compare the reliability and validity of a new device with~     standard methods for diagnosing between amniotic fluid leakage due to premature rupture of~     the membranes (PROM) and urine.~   "
117519|NCT01517776|"~     The primary objective of this study is to evaluate the efficacy of a combined treatment with~     cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS)~     after diagnosis of relapse or tumour progression in children and adolescents with relapsed~     or refractory high-grade malignant glioma and diffuse intrinsic pontine glioma.~      Secondary objectives include:~        1. To evaluate the safety and toxicity of the study treatment by common toxicity criteria~          (CTC; version 4.0).~        2. To assess~             -  the response rates at 6 months (continuous complete response = CCR, complete~               response = CR, partial response = PR, stable disease = SD, progressive disease =~               PD) and~             -  progression-free survival (PFS) at 6 months, and~             -  response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of~               tumor progression. Response will be presented including histopathological~               variants.~        3. To assess the pharmacokinetics of cilengitide administered as part of the study~          treatment.~      Indication and study population for this trial:~      Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas~     in paediatric patients ≥ 3 years and < 18 years of age.~      Patients included in the study receive~        -  Cilengitide 1800 mg/m² i.v. twice weekly~        -  Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory~          platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely:~          Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50~          - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until~          platelet recovery ≥ 100 000/µl (≥100 Gpt/l)~        -  Study treatment in the individual patient is scheduled for 1 year unless tumor~          progression or excessive toxicity occurs. However, study treatment may be extended~          beyond 1 year upon individual decision.~   "
117520|NCT01517763|"~     A total of 216 patients will be randomized into a partially single blind, randomized,~     parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can~     improve therapy adherence when compared to standard care with a fixed pressure Continuous~     Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP~     device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously~     diagnosed with moderate-severe obstructive sleep apnea (OSA).~   "
117521|NCT01517750|"~     Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper~     airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of~     the only technological advancements shown to increase adherence is heated humidification,~     now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique~     technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to~     deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to~     conventional humidification in reducing side effects, condensation and titrated pressure as~     well as increasing total sleep time. However, improved humidity delivery has not lead to~     significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.~      A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a~     single blind, randomized, parallel-arm trial to determine whether the the use of heated~     humidification will impact therapy adherence.~   "
117522|NCT01517737|"~     Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with~     anticipated long-term survival since the bearing surfaces wear less than the traditional~     metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of~     the wear is a concern because of the possible toxicity to cells. In Norwich England a number~     of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had~     very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom~     more than 20% have now been revised. There is an ongoing MHRA program to screen for problems~     using MRI scans with a technique developed in Norwich. Investigations so far show massive~     corrosion in the implants with a catastrophic immune response causing death of cells. This~     may include death of bone leading to fracture. In a third of patients revised there has been~     pain but normal plain X-rays. In some patients without pain who have been screened there are~     abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find~     out why this has happened. The study will include patients coming for a new hip to act as a~     comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and~     MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.~   "
117523|NCT01517724|"~     The aim of this trial is to determine whether bortezomib improves response and delays~     progression for multiple myeloma patients after high dose therapy and autologous stem cell~     transplant. It will also assess the effect of bortezomib treatment on patient bone health.~   "
117524|NCT01517711|"~     This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for~     posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related~     PTSD (n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 20) will be~     recruited. Blinded tramadol ER will begin with a 100 mg daily dose for the first week, with~     an option to increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of~     100-300 mg tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The~     primary hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce~     the symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms~     as rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions~     scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms~     will be stratified to ensure equivalence of the two arms (men and women, military and~     civilian trauma).~   "
117525|NCT01517698|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     investigate the efficacy and safety of RO4917523 in adolescent and adult patients with~     fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of~     RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12~     weeks.~   "
117526|NCT01517685|"~     This research is being done to study the effect of taking flax seed oil and fish oil on~     blood lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our~     health and we want to see how effective both flax seed oil and fish oil are in raising your~     Omega 3 Score (higher is better). The Omega 3 Score is one of many indicators that may show~     your personal risk of dying suddenly from a heart attack.~   "
117527|NCT01517672|"~     Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help~     elucidate reasons for variable treatment response and identify novel treatment targets.~     Exposure-based therapies have been associated with decreased amygdala and increased~     cingulate cortex response during emotional processing. The current study examined whether~     cognitive therapy for PTSD in women reduces activation in insula and amygdala and enhances~     activation in prefrontal regions during emotional anticipation and pre-treatment prefrontal~     activation predicts treatment response.~   "
117528|NCT01517659|"~     Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the~     ZELTIQ CoolSculpting System.~   "
117529|NCT01517646|"~     This study is being performed to reduce unwanted fat, in various body areas, using a new~     applicator and control unit for Zeltiq.~   "
117531|NCT01517620|"~     This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and~     safety of total glucosides paeony capsules in maintaining clinical remission in patients~     with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy.~     Patients will be divided into two groups randomly, one group receive non-steroid~     anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides~     paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the~     proportion of patients which disease activity reaches relapse criteria. The investigator's~     hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group~     would be lower than the NSAID mono-therapy group.~   "
117532|NCT01517607|"~     This non-interventional study examines whether the patient's level of information and the~     consideration of the patient's preference have a positive effect on the compliance and thus~     also on the therapeutic success.~   "
117533|NCT01517594|"~     Confirmation of safety profile~   "
117534|NCT01517581|"~     White and brown adipocytes differ in their expression of hormones, cytokines, and~     inflammatory factors, and they modulate different biological functions. While white adipose~     tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT)~     instead metabolizes fat to produce heat and regulate body temperature. BAT is likely present~     in all humans, but the low prevalence of BAT depiction in adults and elderly subjects has~     hindered longitudinal assessments of the relation between BAT activity and WAT. Under~     typical imaging conditions, BAT is detected more frequently in children and teenagers than~     in adults with malignancy. Since most children with cancer have significantly shorter~     treatment courses and greater survival rates compared to adult patients, the investigators~     have the ability to examine the relation of repeated measures of body composition and BAT by~     selecting pediatric patients. In this study, the investigators will longitudinally examine~     whether BAT activity is related to changes in weight and the amounts of SAT, VAT, and~     abdominal muscle in children successfully treated for pediatric cancer.~   "
117535|NCT01517568|"~     This trial is conducted in Europe. The aim of this trial is characterise the metabolic~     profile of liraglutide in plasma, urine, and faeces after a single injection of~     [3H]-liraglutide.~   "
117536|NCT01517555|"~     This trial is conducted in Europe. The aim of this trial is to to investigate if there is a~     drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the~     effect of liraglutide on post prandial glucose.~   "
117537|NCT01517542|"~     Stroke is the leading cause of disability worldwide and the leading cause of death in~     Brazil. It is estimated that about 18 million people will have a stroke in 2015 and~     approximately one third of these resulting in death. The factors most important modifiable~     risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia,~     sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk~     of another stroke. Healthy eating is among the changes in lifestyle that are recommended for~     prevention and treatment of one of the main risk factors for stroke. Studies show that the~     adoption of the DASH diet can significantly reduce blood pressure and the result is even~     more significant in hypertensive patients, making this diet a new alternative in the~     prevention and treatment of hypertension and consequently stroke. Compliance therapy is a~     determining factor for success in the treatment of chronic diseases. Adherence to long-term~     treatment in developed countries is around 50% and in developing countries the rates are~     even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling~     in an adapted DASH style diet on body weight, glycemic control, blood pressure values and~     improved lipid profile compared to the usual diet without nutritional counseling in patients~     with stroke within the last 3 months. The hypothesis is that nutritional counseling with an~     adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet~     without nutritional counseling in patients with stroke within 3 months. The stroke patients~     will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas~     de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be~     randomized to one of the 2 groups. In the first visit they will be submitted to a social~     class and international physical activity questionnaire and they will be submitted to a food~     frequency questionnaire, measures of weight, height, waist circumference, hip and neck,~     blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9~     and 12 months. The main endpoints will be the change in the body weight, blood glucose,~     blood pressure values and lipid profile.~   "
117538|NCT01517529|"~     The major goal of this project is to identify the role of the immune responses in the~     emergence of protease inhibitor mutants during therapy.~   "
117539|NCT01517516|"~     The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of~     Structural Neuroimaging is to use MRI technology to identify cortical and white matter~     morphometric differences between patients with chronic pain conditions and healthy control~     subjects.~      The purpose of the Resting State Neuroimaging study is to use functional MRI to identify~     possible disease related differences in various resting state networks in the brain.~      In addition we are looking at the effect gut microbiota on brain function in healthy and IBS~     participants.~      The overall goal is to identify structural and functional brain differences in persons with~     chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting~     Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel~     Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between~     these conditions and matched healthy control subjects.~   "
117540|NCT01517503|"~     The study will investigate the effectiveness of Cognitive Therapy and Acceptance and~     Commitment Therapy in a randomized controlled trial among patients with Major Depressive~     Disorder in routine clinical practice. Furthermore, the study will investigate whether each~     specific treatment approach is mediated by its proposed theoretical mechanism.~   "
117541|NCT01517490|"~     Retinal function is highly dependent on the glucose supply. Thus, functional adaptations~     occur in response to both acute and long-term changes in glycaemia.~      The purpose of this study is to examine functional and metabolic aspects of retinal~     adaptation to long-lasting changes in glycaemic control in patients with diabetes. The~     adaptational phenomena will be characterized by electroretinography, dark adaptation,~     measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and~     (OCT).~   "
117542|NCT01517477|"~     The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure~     (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on~     two anti-glaucoma medications.~   "
117543|NCT01517464|"~     This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of~     SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we~     will look for evidence of RB94 expression within tumor tissue after systemic administration~     of SGT-94.~   "
117544|NCT01517451|"~     A study to see how effective and tolerable radiation therapy along with androgen deprivation~     therapy is in treating prostate cancer.~   "
118348|NCT01506843|"~     The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody~     response changes after SLIT using house dust mite allergen with or without bacterial~     extracts in mite-allergic children.~   "
117545|NCT01516476|"~     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the~     efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately~     controlled with metformin alone. Patients will be randomized to receive doses of RO6807952,~     placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.~   "
117546|NCT01516463|"~     Subjects who have minor, second degree burns may be enrolled in this study. Subjects will~     receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals.~     Bandages will be used to keep the burn covered while it heals. Second degree burns generally~     leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to~     minimize the appearance of a scar.~      The study hypothesis is that burns treated with Santyl will have a better scar appearance~     than burns treated with bacitracin.~      Subjects enrolled in this study will make once a week visits to the University of Kansas~     Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for~     healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up~     to 1 year. At these visits, the appearance of the scar will be evaluated~   "
117547|NCT01516450|"~     This study is an open-label, randomized, 2 parallel group, single dose study in healthy~     Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous~     administration and single subcutaneous administration of GSK1550188. Serial blood samples~     for the determination of GSK1550188 concentration will be collected and safety assessments~     will be performed for each treatment group~   "
117548|NCT01516437|"~     The present study aims to assess the natural immunity to specific microbial antigens in~     healthy subjects and in subjects with stable COPD aged between 45-75 years.~   "
117549|NCT01516424|"~     A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical~     trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with~     Risperidone~   "
117550|NCT01516411|"~     The purpose of this research is to test programs to increase physical activity and reduce~     sedentary behavior using motivational messages over a cell phone.~   "
117551|NCT01516398|"~     A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes~     and death for premature infants. Infants with BPD are also at high risk for pulmonary~     hypertension (PH)—an important contributor to their condition. Previous research has~     suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary~     disease.~      This study aims to investigate the incidence of PH and levels of ET-1 among premature babies~     with BPD. It will also potentially allow us to focus further research efforts and treatment~     towards these infants, some of our sickest patients at LPCH.~   "
117552|NCT01516385|"~     This research looks for markers in the blood of people with spinal cord injury that may be a~     sign of injury severity, or serve as a clue to the degree of recovery. Investigators would~     also like to compare the marker profile of these patient with that of other neurological~     conditions such as stroke and Guillain-Barre syndrome.~      Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba~     medical center, Israel. They will join the trial at their arrival to the ward, no less than~     2 week after the beginning of their condition, but no later than 3 months.~      Patients will be examined by the research staff three times:~        1. At arrival, the patients will be neurologically examined and their functional abilities~          will be assessed. Blood will be drawn and sent to the lab.~        2. At 6 months after the beginning of the neurological condition the same will be~          repeated: the patients will be neurologically examined and their functional abilities~          will be assessed, and blood will be drawn and sent to the lab.~        3. The final examination will take place 1 year after the beginning of the neurological~          condition. This time only the neurological and functional abilities will be assessed~          without blood tests.~      The blood samples will be tested in the research lab. Then investigators shall compare the~     clinical findings with the laboratory findings, and see if any of the markers found reflect~     the injury severity or predict the recovery.~   "
117553|NCT01516372|"~     This will be a randomized, double-blind, placebo- controlled cross-over study to investigate~     the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive~     control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will~     take part in four dosing sessions. Subjects will receive, in a randomized order, a single~     dose of 1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive~     control) and placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose~     to approximately 24 hours after dosing on Day 1 of each study session. The primary~     comparison of interest will be the mean change from baseline in the time-matched differences~     in QTcF between each GEn treatment and placebo.~   "
117554|NCT01516359|"~     The purpose of this study is to investigate the incidence and predictive factors related to~     intestinal injury in patients undergoing heart valve replacement through a multicenter study~     in China.~   "
117555|NCT01516346|"~     The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide~     dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints~     include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity~     (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection~     Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave~     reflections induced by vasoactive therapy will correlate with the improvement in exercise~     capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the~     hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the~     sustained changes in the reflected wave and other hemodynamic parameters in response to~     chronic vasodilator therapy.~   "
117556|NCT01516333|"~     The study is to examine the effect of four diets differing in glycemic index and amount of~     carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.~   "
117557|NCT01516320|"~     The objective of this study is to investigate the different mechanisms by which Gastric~     Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy~     (VSG) affect glucose control. We wish to understand the role of weight loss versus changes~     in gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes~     Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent~     weight loss and at after surgery in terms of gut hormones levels, insulin secretion and~     glucose control.~   "
117559|NCT01516294|"~     This study will evaluate the efficacy of IRay treatment in patients with Polypoidal~     Choroidal Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion~     of lesion activity and lesion size at 12 months.~   "
117560|NCT01517438|"~     ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or~     adenoidectomy in children~   "
117561|NCT01517425|"~     This research is being done to understand how changes in DNA may put people at risk for~     developing coronary artery disease. Stem cells will be made using cells from blood and/or~     skin biopsy samples. We are trying to understand which specific changes in DNA negatively~     impact a person's health.~   "
117562|NCT01517412|"~     Primary Objective:~      - To compare the two treatment regimens in terms of change of glycosylated hemoglobin~     (HbA1c) from baseline to endpoint (Week 24)~      Secondary Objective:~        -  To assess the effect of the 2 lixisenatide regimens on:~             -  The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at~               Week 24~             -  Fasting Plasma Glucose (FPG)~             -  7-point Self-Monitored Plasma Glucose (SMPG) profiles~             -  Body weight~        -  To assess the safety and tolerability of the 2 lixisenatide regimens~   "
117563|NCT01517399|"~     The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics~     of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer.~   "
117564|NCT01517386|"~     For effective anesthesia and interventional pain treatments, correct needle placement is~     crucial. Currently used methods to guide needle placement and confirm the actual treatment~     location before injection of the medication include: image-guidance, loss-of-resistance, and~     electrical stimulation. However, accuracy of needle placement could be improved if~     information would be available that would complement the current methods. We have developed~     the so-called photonic needle technology based on optical spectroscopy that has the~     potential to provide such complementary information.~      This study is an observational study in a limited number of patients. A common~     ultrasound-guided regional anesthesia procedure has been selected, during which data will be~     acquired with the photonic needles at a number of points along the needle trajectory that~     allow for confirmation by imaging.~      Rationale for this study is to investigate the potential of the technology to discriminate~     tissues that are relevant to distinguish during the procedure.~   "
117565|NCT01517373|"~     This is a study to understand efficacy and safety of investigational agent (PF-04937319)~     compared to approved agent (glimepiride) in patients with diabetes on metformin~   "
117566|NCT01517360|"~     This study will evaluate whether oxytocin will facilitate the learning of social cognitive~     skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training~     (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin~     will demonstrate greater improvements in a summary measure of social cognition than subjects~     treated with placebo over the course of SCST.~   "
117567|NCT01517347|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia. However, relapse rate was still the key question to~     influence the overall survival after transplantation, even in standard risk leukemia.There~     were good evidences that natural killer cells and T regulatory cells, which were expanded~     and stimulated by the application of IL-2, could mediate protection against GvHD while~     maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in~     our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a~     prolonged period could be a safe and effective strategy to prevent relapse in acute~     lymphoblastic malignancy patients with high risk of recurrence after unmanipulated~     allo-HSCT.~      The study hypothesis:~      Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation~     in patients with standard risk acute leukemia can~        -  reduce relapse rate~        -  improve survival~   "
117568|NCT01517334|"~     The objective of the study is to evaluate the safety, effectiveness and anti-microbial~     effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with~     peri-implantitis, when used in combination with mechanical debridement.~      The hypothesis of the study is that Arestin in combination with mechanical debridement is~     more effective in the treatment of peri-implantitis when compared to mechanical debridement~     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as~     measured at qualifying implant sites.~   "
117569|NCT01517321|"~     This Phase III clinical trial will examine the safety, tolerability, and efficacy of the~     addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have~     inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue~     monotherapy.~   "
117570|NCT01517308|"~     Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic~     hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the~     efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated~     whether 48 weeks of therapy may achieve better results compared to the standard duration (24~     weeks).~   "
117571|NCT01517295|"~     Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite~     hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3~     months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.~   "
117572|NCT01517282|"~     Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous~     system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits~     an unpredictable and variable clinical course.~      Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have~     been identified to contribute significantly to demyelination in both clinical MS and animal~     models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates~     proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic~     cells and microglia with subsequent induction of proinflammatory biomolecules.~      Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.~   "
117573|NCT01517269|"~     Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have~     significantly higher diabetes knowledge (cognitive visual schemata), better technical and~     problem-solving competence and confidence, and lower fear and stress/anxiety levels; and~     provide better diabetes management at 14 weeks compared to those parents receiving standard~     diabetes education.~   "
117574|NCT01517256|"~     The investigators will evaluate the effectiveness of Living Everyday Above-and-beyond Pain~     (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group~     therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family~     Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of~     life, interaction with the health care system and their health care utilization. This is a~     pilot study to evaluate mainly feasibility. The investigators will make use of both~     experimental and qualitative methods gather evidence of the programs success, strengths and~     weaknesses.~   "
117575|NCT01517243|"~     In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on~     agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the~     vascular endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of~     mammalian target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved~     agents for mRCC. When agents like these are given together, the toxicity increases but they~     can be given safely, at full doses, sequentially. We hypothesize that alternating these~     agents will double the progression free survival (PFS) of the agents when given~     sequentially.~   "
117576|NCT01517230|"~     A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a~     comprehensive mass media campaign using local radio stations can change behaviours on a~     scale large enough to result in measurable and sustainable reductions in under-five child~     mortality.~      It is hypothesised that as a result of the scale and multi-pronged nature of the campaign,~     reductions of between 10% and 20% in child mortality will be achieved.~   "
117577|NCT01517217|"~     There is a considerable lack of knowledge in everyday surgical practice concerning treatment~     with a corset after laparotomy, in surgery for incisional hernia or as conservative~     treatment.~      The aims are to elucidate effects of corset treatment on patient experience and pain,~     physiology and abdominal wall strength.~      Effects of corset treatment after laparotomy will be studied in a randomised trial with the~     hypothesis that postoperative corset-use improves respiratory physiology and reduce pain.~     The primary end-point is PeakCoughFlow change, secondary end-points are vital capacity,~     residual volumes and patient perception as measured by the ventral hernia pain questionnaire~     (VHPQ) developed by our group. This study is powered for 50 patients.~      Conclusions from the study are of such a nature that they can be immediately transferred to~     clinical practice.~   "
117578|NCT01517204|"~     The purpose of this study is to investigate the effects of Trachway(R) compared with direct~     laryngoscope in tracheal intubation of double-lumen endobronchial tube.~   "
117579|NCT01517191|"~     This surveillance study will include all consenting adults hospitalized with influenza~     (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to~     assess vaccine effectiveness in each group. Both groups will be followed throughout their~     hospitalization and for 30 days post discharge to monitor severity of illness and outcomes~     following their illness.~   "
117580|NCT01517178|"~     The primary object of this study is to provide clinical documentation for the New base plate~     significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care~     base plates.~      The secondary objectives are to provide clinical documentation on several performance and~     safety parameters on the New base plate compared to Standard Care base plates.~      The primary hypothesis is that the New base plate significantly reduces degree of leakage~     under the base plate compared to Standard Care base plates.~      Each test period will last for two weeks. In addition to this there will be one week run-in~     period on New base plate. The data will be collected by investigator in the Case Report Form~     at the inclusion visit, cross-over visit and termination visit. Data will also be collected~     by the subject in a questionnaire during the two test periods.~      The subjects will change their base plates on per need basis and continue with their normal~     changing pattern in the entire study period.~      100 subjects with ileostomy will be included in the study. The subjects will be recruited~     from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.~   "
117581|NCT01517165|"~     Background:~        -  Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and~          diarrhea. Many people have these symptoms when trying to stop using opioid drugs.~          Long-acting opioids like methadone and buprenorphine are used to help people stop using~          other opioids, but these drugs can cause the same withdrawal symptoms. There are no~          non-opioid drugs that are approved specifically to treat those symptoms.~        -  Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug~          allowed heroin users to decrease their methadone dose faster without much discomfort,~          and stay abstinent from heroin. Researchers want to learn more about how pioglitazone~          helps treat opioid withdrawal symptoms.~      Objectives:~      - To test whether pioglitazone can reduce opioid withdrawal symptoms.~      Eligibility:~      - Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid~     dependency.~      Design:~        -  This study will last up to 17 weeks. Participants must come to the study clinic every~          day for at least 13 weeks.~        -  Participants will be screened with a physical exam and medical history. They will also~          answer questions about drug use habits, and provide blood and urine samples.~        -  Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose~          will be increased to a level that should help stop the use of opioids. For the next 4~          weeks, the dose will be decreased. Blood, urine, and breath samples will be collected~          at different study visits. Participants will also fill out questionnaires about mood,~          drug craving, and withdrawal symptoms.~        -  After 1 week on buprenorphine, participants will start the study pill (pioglitazone or~          a placebo) every day. They will take the study pill for 13 weeks.~        -  During the treatment period, participants will have drug counseling once a week for 30~          minutes.~        -  Some participants have other tests as part of this study. These tests include~          functional magnetic resonance imaging scans to look for changes in brain activity and~          giving samples of cerebrospinal fluid to study brain chemistry.~        -  Participants will have a final followup phone call 3 weeks after the last clinic visit.~   "
117591|NCT01517035|"~     Background:~      - People who have some kinds of cancer can benefit from donated bone marrow stem cells.~     These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal~     cells. However, stem cells transplants do not always work. Also, they may have serious side~     effects that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is~     studying methods to make stem cell transplant procedures safer and more effective.~      Objectives:~      - To test a new procedure that may improve the success and decrease the side effects of stem~     cell transplants.~      Eligibility:~        -  Individuals 10 to 75 years of age who have a life-threatening illness that may require~          a stem cell transplant.~        -  Healthy siblings who are able to provide stem cells for transplant.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and~          urine tests.~        -  Donor procedures:~        -  Stem cell donors will start by having apheresis to donate white blood cells.~        -  Donors will receive filgrastim shots for 5 days to help move stem cells into the blood~          for collection.~        -  Donors will have another round of apheresis to donate the stem cells for transplant.~        -  Recipient procedures:~        -  Before the transplant, recipients will have radiation twice a day for 3 days and~          chemotherapy for 7 days.~        -  After the radiation and chemotherapy, recipients will receive the stem cells provided~          by the donor.~        -  After the transplant, recipients will receive the white blood cells provided by the~          donor.~        -  Recipients will be monitored closely for 4 months to study the success of the~          transplant. They will have more followup visits at least yearly thereafter.~        -  Recipients will have a research apheresis prior to transplant and at 3 months.~   "
117593|NCT01517009|"~     The purpose of this study is to determine the feasibility of chemotherapy, consisting of~     docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer.~     Furthermore, an extended type of removal of lymph nodes will be implemented.~   "
117582|NCT01517152|"~     Background:~        -  The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and~          side effects that may occur when people are having cancer treatment. Doctors and nurses~          use this list to describe the side effects patients experience from cancer treatment.~          We have developed a questionnaire to ask people having cancer treatment directly about~          common symptoms and side effects and to supply this information to their doctors and~          nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient.~        -  PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish~          version of the patient questionnaire. To test whether the questions are well understood~          and whether it is easy to complete the questionnaire, the researchers will interview~          individuals whose primary language is Spanish and who are being treated for different~          types of cancer.~      Objectives:~      - To test a Spanish version of the PRO-CTCAE questionnaire.~      Eligibility:~      - Latinos at least 18 years of age who are having or have recently finished cancer~     treatments and whose main language is Spanish~      Design:~        -  Participants will complete a questionnaire in Spanish with selected questions from the~          translated PRO-CTCAE. They will discuss their answers and any difficulties they might~          have had in understanding or answer the questions with an interviewer, who will take~          notes and record comments and suggestions.~        -  Literacy is not required for this study. Participants may opt to have the questions~          read aloud to them by an interviewer.~   "
117583|NCT01517139|"~     Background:~      - Researchers want to collect information on diet, physical activity, and sun exposure in~     children and young adults. The data can provide information on the effect these factors~     might have on the development of cancer and other diseases. Information collected only from~     adults does not accurately measure these factors. To collect more accurate information, both~     mothers and children will provide information. Study participants will be from Hebei~     province in northeastern China and Jiangsu province in eastern China.~      Objectives:~      - To collect and study diet, activity, and sun exposure data from Chinese adolescents and~     their mothers.~      Eligibility:~        -  Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.~        -  Mothers of the study adolescents.~      Design:~        -  Participants will answer questions about their diet, physical activity, and time in the~          sun.~        -  Participants will wear a pedometer to measure activity for 7 days. They will also wear~          a badge to measure sun exposure for 3 days.~        -  Participants will record their activities and food and drinks consumed for 3 days.~          Urine samples will be collected for a full day.~        -  Participants will have a grip strength test. On the last day of the study, they will~          provide blood, saliva, and toenail samples.~        -  A smaller separate group of adolescents will provide saliva samples only and complete a~          food questionnaire.~   "
117584|NCT01517126|"~     Background:~      - Currently, there is no standard method to study suicide risk in youth with developmental~     delays or intellectual disabilities (DD/ID). Youth with DD/ID are often excluded from~     studies that are used to develop these methods. As a result, most current suicide risk~     assessments have not been tested for use with people with DD/ID. Researchers want to develop~     an effective suicide risk screening tool for children and adolescents with DD/ID.~      Objectives:~      - To develop a suicide risk screening tool for young adults with DD/ID.~      Eligibility:~        -  Young adults between 12 and 21 years of age who have DD/ID and are in mental health~          counseling.~        -  Participants will be in counseling at Surrey Place Centre, a community health center in~          Toronto, Canada.~      Design:~        -  Participants will fill out questionnaires during a 1-hour meeting with a therapist. The~          questions will ask about mood and current feelings, including whether the participant~          has been thinking about or planning to hurt or kill him or herself now or in the past.~          Other questions will ask about participants' understanding of death in general.~        -  Parents of participants may also fill out a questionnaire. It will ask about how the~          participant has been feeling. It will also ask whether the parent has noticed any signs~          that suggest suicidal thoughts or actions, now and in the past.~        -  Treatment will not be provided as part of this protocol. However, participants can~          receive counseling through the regular Surrey Place Centre services.~   "
117585|NCT01517113|"~     Background:~      - Advancing age is associated with greater risk of heart disease. High blood pressure and~     hardening of the arteries also have more complications with age. Studies suggest that~     age-related inflammation may affect fatty tissue in the body. If this fat develops in the~     muscles or around the heart, it may increase risks of heart disease. Researchers will study~     body composition in older adults to see if age-related changes in body fat are related to~     higher risks of heart disease.~      Objectives:~      - To study the relationship between fat deposits and aging, and greater risks of heart~     disease.~      Eligibility:~        -  Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of~          age.~        -  Individuals between 50 and 80 years of age who have been diagnosed with coronary artery~          disease.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will provide blood and urine samples. They will also have their height and~          weight measured. Waist circumference will also be taken.~        -  Participants will have a DEXA scan to study their muscles.~        -  Participants will have magnetic resonance imaging scans. These scans will study heart~          function and muscle and blood vessel health.~        -  Participants with coronary artery disease will have catheterization. Blood samples will~          be collected during the procedure.~   "
117592|NCT01517022|"~     The aim of the study is to determine the impact of a package of smoking-cessation~     interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.~      Given the lack of objective clinical data/evidence about the impact of smoking-cessation on~     TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely~     to be beneficial particularly in patients with TB, this study proposes to determine the~     impact of an intensive package of smoking-cessation interventions aimed to promote~     smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response~     to anti-tuberculosis therapy. This is to be compared with the structured counselling for~     smoking-cessation that is recommended to be routinely provided by health care workers to all~     patients who are smokers. If the results prove that such a smoking-cessation PI indeed~     improves outcomes in TB patients, such information would strongly motivate for the~     institution of more intensive smoking-cessation interventions in TB clinics than is~     currently being employed for TB patients~   "
117586|NCT01517100|"~     Background:~      - The endocannabinoid system is involved in different body functions and processes. It helps~     regulate appetite and mood, and sends signals to the nervous system. It may also be involved~     in how the body produces insulin during digestion. Researchers want to test two drugs that~     work on the endocannabinoid system: nabilone and CP-945,598. These drugs may be able to~     affect insulin levels in the blood. This information may suggest possible new treatments for~     people with diabetes.~      Objectives:~      - To study how the endocannabinoid system is involved in insulin production and action.~      Eligibility:~      - Healthy men between 21 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples. They will also have imaging studies to test their~          brain responses, especially to food-related cues. Some participants will also have a~          study visit to test their insulin resistance levels.~        -  Participants will have four separate study visits 6 weeks apart. They will keep a food~          diary before each visit. At each visit, they will have one of the following~          combinations of drugs:~        -  Double placebo~        -  Placebo and nabilone~        -  Placebo and low dose of CP-945,598~        -  Placebo and high dose of CP-945,598.~        -  Participants will have follow-up visits 1 week after each study visit. Blood samples~          will be taken.~   "
117587|NCT01517087|"~     Background:~      - People with motor neuron disorders have changes in the parts of the brain that control~     movement. Some tests that are currently used to study these changes are magnetic resonance~     imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and~     TMS give the same results if done at different times in the same person. Researchers want to~     see if these tests produce different results if given to healthy adults on two separate~     occasions.~      Objectives:~      - To test the reliability of different tests of the brain used to study motor neuron~     disorders.~      Eligibility:~        -  <TAB>Healthy individuals at least 35 years of age who have no history of neurological~          disorders and take no medications.~        -  <TAB>Pregnant women may not participate.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have two testing visits 1 to 6 months apart.~        -  The first visit will have three parts. The first part is a neurological exam to test~          strength, sensation, reflexes, and coordination of movement. The second part will be~          TMS tests. The third part will involve an MRI scan to study the parts of the brain that~          control movement.~        -  At the second visit, participants will have MRI scanning only.~   "
117588|NCT01517074|"~     Background:~      Autoimmune scleritis is an inflammatory disease that affects the white outer part of the~     eye. It is associated with immune system disorders like rheumatoid arthritis. It can cause~     blindness in severe cases. Most treatments for scleritis involve steroid or~     immune-suppressing drugs, but these can cause side effects in the whole body.~      Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune~     system from attacking the body. Researchers want to try giving sirolimus injections into the~     eye to treat severe scleritis.~      Objectives:~      To see if sirolimus is a safe and effective treatment for autoimmune scleritis.~      Eligibility:~      Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has~     not responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history, physical exam, and eye exam.~          Blood and urine samples will also be collected.~        -  One eye will be selected as the study eye to receive injections.~        -  Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8,~          12, and 16). The injection will be given at the first visit. If the study eye responds~          to the treatment, participants may have injections in the other eye at the second~          visit.~        -  If there is still inflammation after the first injection, or if the scleritis improves~          but then returns, participants may have a second injection at Week 4.~        -  Injections will be monitored with blood tests and eye exams.~        -  Participants may have study visits and injections for up to 1 year if the injections~          seem to be working.~   "
117589|NCT01517061|"~     Background:~      - Many people who lose a limb feel pain in the missing limb. This feeling is called phantom~     limb pain. Researchers do not fully understand what causes this pain. Differences in~     people's genes may play a role. Comparing the genes of people with and without phantom limb~     pain may help researchers better understand this feeling, who is likely to develop it, and~     how to treat it.~      Objectives:~      - To study whether genetic differences affect phantom limb pain.~      Eligibility:~      - Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will answer questions about how they lost the limb, and whether they feel~          phantom limb pain. They will also have a test to measure their sensitivity to heat and~          cold.~        -  Participants will provide a blood sample for genetic testing.~   "
117590|NCT01517048|"~     Background:~      - Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause~     problems with appetite regulation. People with PWS often have behavior and thinking~     problems. People with MC4R mutations may have problems with attention. These problems may be~     related to Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain~     development. Researchers want to study people with PWS and MC4R mutations to see how BDNF is~     involved in these conditions. Specifically, body weight and brain function will be studied,~     and compared with healthy volunteers.~      Objectives:~      - To study how BDNF affects body weight and brain function in people with PWS and MC4R~     mutations.~      Eligibility:~        -  Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations.~        -  Healthy volunteers of any age to act as control participants.~      Design:~        -  Participants will be screened with a medical history and physical exam. Height, weight,~          and waist/hip circumferences will be measured. Blood samples will be taken for genetic~          and other tests.~        -  Participants will fill out questionnaires about eating habits, pain perception, and~          sleep behavior.~        -  Participants will keep a 3-day food diary to record all food and drinks eaten.~        -  Tests and questionnaires will be given to study thinking, speech, movement, behavior,~          and mood. Some tests will be done on a computer; other tests will be on paper. Tests~          may also involve performing tasks with blocks and other objects.~        -  Participants may have other tests as directed. These will include hot and cold~          sensitivity tests, imaging studies like x-rays, and measurements of body fat and water~          content.~        -  Treatment will not be provided as part of this study.~   "
117594|NCT01516996|"~     The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to~     neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with~     locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.~   "
117595|NCT01516983|"~     The purpose of this study is to evaluate the safety and tolerability of Icotinib at~     different dose levels in combination with whole brain radiotherapy for NSCLC patients with~     brain metastases and EGFR mutation.~   "
117596|NCT01516970|"~     The primary purpose of this study is to assess the rate of early discontinuation from~     randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason~     other than confirmation of the negative HIV infection status of the index person in patients~     receiving HIV PEP for at least 28 and a maximum of 30 days.~   "
117597|NCT01516957|"~     The study will examine the safety and effectiveness of AMG 827 for the treatment of~     psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like~     liquid that does not have any drug in it) and neither the doctor nor the patient will know~     what treatment is being given.~   "
117598|NCT01516944|"~     Stage I：Neoadjuvant therapy~        -  Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to~          surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and~          Oteracil Potassium Capsules plus oxaliplatin~      Stage II: Perioperative therapy~        -  Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is~          superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin~          alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and~          Oteracil Potassium Capsules plus oxaliplatin~        -  A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX)~          and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with~          incurable locally advanced or metastatic gastric cancer. The investigators assessed~          whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant~          alone improves R0 resection rate and survival among patients with curable locally~          advanced gastric cancer.~   "
117599|NCT01516931|"~     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic~     stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome~     Measures:Time between subject randomization to treatment and the first occurrence of a~     relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as~     measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by~     Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject~     functioning using the Personal and Social Performance Scale.~   "
117600|NCT01516918|"~     The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen~     (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with~     cirrhosis.~   "
117601|NCT01516905|"~     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404~     PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by~     determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and~     calculating tumor dosimetry. A future aim of this study will be to compare non-invasive~     PET/CT and MRI findings with pathological specimens, which is the gold standard but is~     invasive and impractical in many cases, to determine the sensitivity and specificity of both~     techniques for accurately detecting tumor infiltration. The data obtained from this study~     will be used to develop larger diagnostic and therapeutic trials in brain tumors. The~     long-term goals of this research are to improve the diagnosis and treatment of malignant~     brain tumors by using radioiodinated NM404.~   "
117602|NCT01516892|"~     This open-label study will assess the long-term efficacy, safety, and tolerability of~     onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic~     migraine.~   "
117603|NCT01516879|"~     To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC)~     evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering~     therapy.~   "
117604|NCT01516866|"~     The purpose of this research study is to evaluate a newer imaging technique, called~     18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is~     very sensitive for changes in bone. By using this tracer with positron emission~     tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes~     in bone lesions could be greatly improved.~   "
117605|NCT01516853|"~     The purpose of this study is to validate magnetic resonance imaging as a biomarker of~     hepatic iron concentration (HIC). Excessive accumulation of iron in the body is highly~     toxic, specifically in the liver. Accurate, non-invasive assessment of HIC is needed for~     diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.~   "
117606|NCT01516840|"~     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and~     pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein~     thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary~     embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.~   "
117607|NCT01516827|"~     This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused~     Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino & Deblinger (2006)~     with a wait-list condition in a population of children aged 7-16 years who were exposed to~     traumatic events beyond the age of three years, at least three months ago, and developed~     Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT~     exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of~     treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the~     effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of~     patients and caregivers and to explore moderators and mediators of treatment response. The~     trial will contribute to implement an evidence-based treatment for traumatized children~     across a variety of healthcare settings in Germany. The novel aspect is to evaluate the~     effectiveness of TF-CBT with a broad range of traumatized real-world patients in the~     context of the German mental healthcare system.~   "
117608|NCT01516814|"~     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and~     pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the~     prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in~     Japanese patients with acute symptomatic PE with or without symptomatic DVT.~   "
117609|NCT01516801|"~     1. Does a one-page American College of Physicians educational flyer about the pros and~          cons of prostate cancer screening sent to men within two weeks of their scheduled~          annual health examinations in a general medicine clinic result in a different rate of~          prostate cancer screening than among men who were not sent the flyer?~        2. Do patients find the flyer useful and understandable?~      Context: The use of prostate specific antigen (PSA) screening for prostate cancer is~     controversial because of a lack of evidence that such screening saves lives when applied~     within a population and because such testing can lead to invasive downstream biopsies and~     aggressive treatment that is associated with a high risk of permanent side effects (e.g.~     impotence, incontinence). Almost all professional societies (American Cancer Society,~     American Urologic Association, American College of Physicians, United States Preventive~     Services Task Force) advocate that patients receive education and complete an informed~     decision-making discussion with their medical providers about the pros and cons of the PSA~     test, as well as their personal preferences, before proceeding with this test.~     Unfortunately, despite these recommendations, there is seldom sufficient time during clinic~     visits to achieve this goal.~   "
117610|NCT01516788|"~     Photosensitivity is well documented among lupus patients and is one of the diagnostic~     criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in~     lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly~     defined in lupus and its pathogenesis is not well understood. The purpose of this study is~     to characterize the early clinical and histopathological changes in lupus skin that occur as~     a response to ultraviolet light.~   "
117611|NCT01516775|"~     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to~     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general~     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of~     this study and can be investigated in children undergoing elective procedures in intubation~     anaesthesia without inconvenience or additional invasive procedure and hence without~     additional risk~      Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia~     induction than in those that drink until 2 hours before anaesthesia induction~   "
117612|NCT01516762|"~     This study is a prospective, interventional, open-label, multi-center early access program~     for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis~     and to collect additional short and long term safety data on the product.~   "
117613|NCT01516749|"~     This is an open-label, proof-of-concept research study to assess the effectiveness of~     anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned~     intervention is to provide about 6 HS patients with anakinra 100mg daily injections to~     administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a~     further 8 weeks to monitor for relapse of HS.~   "
117614|NCT01516736|"~     The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to~     the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy~     in breast cancer patients.~   "
117615|NCT01516723|"~     Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by~     high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark~     reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared~     to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar~     favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic~     Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also~     demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with~     bioresorbable polymer coatings were developed, to address safety concerns regarding the~     observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic~     inflammation, on the durable polymer coating of DES. However, none of these DES with~     bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a~     prospective, randomized, single-blinded, multi-center trial, designed to evaluate the~     safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with~     bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with~     durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.~   "
117616|NCT01516710|"~     The purpose of the study is to compare outcomes of laparoscopic versus open liver resection~     for colorectal metastases in a prospective and randomized study. The study will include all~     non-anatomic liver resections in our institution.~      The primary end point is that the use of laparoscopic technique significantly can reduce the~     frequency of complications to liver resection. Secondary end points are 5-year survival,~     immediate surgical outcomes, quality of life and degree of impairment of the immune system.~   "
117617|NCT01516697|"~     The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac~     output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the~     physician promptly, 2) provide information for the physician to make the differential~     diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction~     of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient~     outcome.~      -determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic~     profile of the patient under spinal anesthesia for cesarean section. To determine if using~     instantaneous measurements of SV and CO to guide patient management improves hemodynamic~     stability.~   "
117618|NCT01516684|"~     This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients~     undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the~     skin and reducing movement when applied prior to lumbar punctures and may reduce the amount~     of sedation necessary~   "
117619|NCT01516671|"~     Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to~     severe disability in survivors caused by cerebral vasospasm and infarction.~      This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol~     levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of~     the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.~   "
117620|NCT01516658|"~     HYBRID study is prospective randomized open label controlled multi center trial, to compare~     Hydrocoil and bare platinum coil for recanalization after endovascular treatment of~     intracranial aneurysms.~   "
117621|NCT01516645|"~     This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as~     monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy~     or for whom no standard therapy is available.~   "
117622|NCT01516632|"~     The investigators developed a text messaging-based smoking cessation program called SMS~     (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young~     adults. The investigators hypothesized that those in the SMS USA intervention would be~     significantly more likely to be quit at 6-months compared to the attention-matched control~     group.~   "
117623|NCT01516619|"~     This is a monocentric, prospective phase II trial addressing safety and capability to~     prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with~     NHL.~   "
117624|NCT01516606|"~     This is a prospective, phase II study on the activity and tolerability of high dose (2~     g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal~     zone lymphoma.~   "
117625|NCT01516593|"~     This is a multicenter,open-label trial to evaluate activity and safety of the~     investigational intensive in HIV+ patients with Burkitt's lymphoma.~      Experimental treatment consists of an induction phase followed by a consolidation or~     intensified phase according to tumor response.~      Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL~     was thought to limit the ability to administer intensive chemotherapeutic regimens due to~     infection rate. However, the advent of highly active antiretroviral therapy (HAART) and~     evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard~     chemotherapeutic regimens with improved outcomes have led investigators to treat~     HIV-positive patients with the same intensive chemotherapy regimens used to treat~     immuno-competent patients. Data suggest that these current approaches, along with supportive~     care, may result in improved patient outcomes, similar to those in the immuno-competent~     patient population.~   "
117626|NCT01516580|"~     The aim of the trial is to test whether adding 6 injections of rituximab to standard~     Lymphome malin B LMB chemotherapy regimen improves the Event Free Survival (EFS) compared~     with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin~     Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).~   "
117627|NCT01516567|"~     Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in~     children and adolescent with primary mediastinal large B cell lymphoma in terms of event~     free survival.~   "
117628|NCT01516554|"~     Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients~     and is often a significant source of disability. Unlike normal fatigue, multiple sclerosis~     related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to~     dysfunction in the neural pathways that regulate the perception of energy although the~     precise cause is still not understood. While MSRF can be managed through lifestyle~     modifications and with drug treatment, these measures are commonly either ineffective or~     only partially effective.~      Administration of the male sex hormone testosterone has been shown to improve energy levels~     in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients~     with other medical conditions not associated with low testosterone levels, suggesting that~     this treatment may also be useful in symptomatic control of MSRF.~      This proposed seven-month long clinical trial is designed to test the hypothesis that~     administration of oral testosterone tablets to male MS patients will result in an~     improvement of fatigue relative to the administration of placebo tablets. As fatigue is~     frequently reported by MS patients to be one of their most frustrating and disabling~     symptoms, any proven additional treatment option for MSRF would be beneficial in improving~     quality of life.~   "
117629|NCT01516541|"~     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will~     evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in~     patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated~     risk for cardiovascular disease. Eligible patients will be randomized to receive either~     dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary,~     guidelines-based medical care. Anticipated time on study treatment is 4 years.~   "
117630|NCT01516528|"~     This is a prospective, observational, non-drug interventional, non-randomized study to~     compare the rate of moderate-severe COPD exacerbations in patients of all Chronic~     Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A~     total study population of 3330 subjects will be recruited by general practitioners (GPs) and~     assessed over a 27 month time frame.~   "
117631|NCT01516515|"~     This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum~     undatum plant extract in patient with Actinic Keratosis (AK).~   "
117632|NCT01516502|"~     Objective: To compare the effectiveness of application of low-level laser therapy (LLLT) to~     trigger points and traditional acupoints for patients with cervical myofascial pain syndrome~     (MPS).~      Design: A single-blinded, randomized, placebo-controlled trial Setting: University~     rehabilitation hospital Participants: One hundred and twenty one patients with cervical MPS~     Intervention: The investigators performed this experiment using low level 810-nm gallium~     aluminum arsenide (Ga-Al-As) laser. One hundred participants were randomly assigned to four~     treatment groups, including (1) acupoint therapy (2) acupoint control (3) trigger point~     therapy and (4) trigger point control groups.~      Main Outcome measures: The investigators evaluated the patient's visual analogue scale (VAS)~     pain scores, pressure pain threshold and cervical range of motion (ROM) before and after the~     therapy.~   "
117633|NCT01516489|"~     This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial~     incentives directly integrated into primary care can improve fecal occult blood test (FOBT)~     completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs~     Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care,~     $5, $10, $20 incentives will each lead to a statistically significant increase in the rate~     of FOBT completion. We also hypothesize that there will be a direct dose-response~     relationship between the incentive amount and rates of FOBT completion. In stage 2, we~     hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a~     statistically significant increase in the rate of FOBT completion compared to a fixed~     payment incentive with an equivalent dollar per patient value.~   "
117634|NCT01516281|"~     The purpose of this study is to learn if a new brain imaging technology called DaTscan can~     detect subtle changes in the brain that are similar to those seen in early Parkinson's~     disease (PD). The results of this study may provide more information about a possible~     association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of~     this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122~     subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University~     HealthSystem during the years 2006-2011, and to select from willing eligible subjects a~     random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to~     undergo written informed consent, neurological examinations, blood drawing for DNA~     extraction and storage, and DaTscan brain imaging. The investigators will compare the~     findings from persons who experienced mTBI (cases) to persons without a history of brain~     injury (mTBI- or controls).~   "
117635|NCT01516268|"~     Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound~     guide can reduce narcotic dosage, side effects and pain after cesarean delivery.~   "
117636|NCT01516255|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered~     as positive control.~   "
117637|NCT01516242|"~     This study is conducted in Europe. The aim of the study is to monitor patients changing~     therapy from syringe to insulin delivery system as prescribed by the treating physician in~     Slovakia.~   "
117638|NCT01516229|"~     This study is conducted in Japan. The aim of this study is to assess the incidence rate of~     adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for~     achondroplasia without epiphyseal line closure under normal clinical practice conditions.~   "
117639|NCT01516216|"~     The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor~     in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell~     death. Vitamin D has been used in other research studies and information from those other~     research studies suggests that Vitamin D may help in the treatment of colorectal cancer.~      In this research study, the investigators are comparing standard and higher dose Vitamin D~     treatment when given in combination with standard treatment for metastatic colorectal~     cancer. Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and~     Oxaliplatin (FOLFOX) with bevacizumab.~   "
117640|NCT01516203|"~     The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day~     14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily,~     500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with~     newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled,~     with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration~     of drug treatment is 14 days.~   "
117641|NCT01516190|"~     This study is designed to look at the changes that occur in women who take part in exercise~     and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators~     will look at changes in stress, anxiety, mood and quality of life, to see if these types of~     short programs can make women feel better during this time. The investigators are also~     interested in looking at whether a short exercise or Mind-Body program leads to any changes~     in markers in breast cancer cells, such as their growth and death rates, or in blood~     hormones such as insulin, which have been linked to breast cancer development.~      Since the investigators do not know if these blood or tumor tests have any relationship to~     cancer recurrence, the investigators do not plan to share the results of these tests with~     you or your physician.~   "
117642|NCT01516177|"~     This is an observational study for people who have received a kidney transplant within the~     past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and~     cells in the blood that has been found in a group of rare transplant patients who do not~     need immunosuppression. The study goal is to find out how common this pattern is in~     transplant patients, as a first step in determining if it can be used to personalize~     anti-rejection drug regimens better.~   "
117643|NCT01516164|"~     Videolaryngoscopes offer the potential to make tracheal intubation easier for the~     anaesthetist and less traumatic for the patient. This study aims to compare the intubation~     difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC~     as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen)~     and the MacIntosh laryngoscopes.~   "
117644|NCT01516151|"~     To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting~     plasma serum triglycerides over a four week period in patients with mild-to-high~     hypertriglyceridemia as compared to the standard of care alone.~   "
117645|NCT01516138|"~     The purpose of this study is to evaluate the effects of modified glucose - insulin -~     potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).~   "
117646|NCT01516125|"~     The purpose of this research study is to screen healthy African American and Caucasian~     persons for specific differences in genes that control how fats are processed in the body.~   "
117647|NCT01516112|"~     The purpose of the registry is to assess workload of a Home Monitoring based follow up for~     Biotronik ICD and CRTD patients.~   "
117648|NCT01516099|"~     The primary aim of this study is to investigate how a physical activity counselor can offer~     an added value in the sports and exercise promotion in Flanders. The investigators will~     explore if the physical activity counselor, in collaboration with the setting of general~     practitioners and social-cultural associations, can refer sedentary people and persons who~     are active in a non-organized context, into systematic participation in sports and/or~     exercise. Additionally, the investigators want to determine if the physical activity~     counselor will succeed in referring the target population to the local supervised and~     structured sports and exercise activities.~   "
117649|NCT01516086|"~     This will be a multi-center, randomized, placebo controlled parallel-group study to~     Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly~     Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks,~     including 12 weeks of double-blind treatment.~   "
117650|NCT01516073|"~     This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate~     nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled~     and uncontrolled asthma. Individual participation will be approximately 16 weeks, including~     12 weeks of double-blind treatment.~   "
117651|NCT01516060|"~     The purpose is to investigate whether HIV and HIV medication can affect certain areas of~     brain function. This study will look at possible changes in brain function including memory,~     concentration and thought processes to see if there are any differences between the two~     doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood~   "
117652|NCT01516047|"~     The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult~     male patients with severe hepatic impairment and is being conducted to collect information~     that will support clinical dosing recommendations for this subpopulation.~   "
117653|NCT01516034|"~     The study is designed to determine the efficacy of the Cupola tattoo removal device for~     tattoo removal.~   "
117654|NCT01516021|"~     The aim of the current study was to investigate the effect of a high versus a low fat meal~     (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.~   "
117655|NCT01516008|"~     The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR~     50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours~     (SPID48) to measure analgesic effect in Korean patients with acute pain following~     bunionectomy.~   "
117656|NCT01515995|"~     The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as~     a vehicle for albuterol in children with moderate to severe asthma exacerbation.~   "
117657|NCT01515982|"~     The state of the art with regard to the neurodegenerative dementias, especially for~     Alzheimer´s disease (AD), is that their progression is still irreversible causing cognitive,~     motor, and behavioral impairment. Although the current pharmacological treatments attenuate~     cognitive decline in some cases, the majority of treatments does not avoid the motor and~     functional changes caused by the progress of the disease. Although several studies show that~     exercise has a positive effect when it comes to the treatment of the disease, some~     methodological questions affect the application of the training protocols. The use of~     recognized intensity patterns like maximum oxygen uptake (VO2max) and maximum heart rate~     (HRmax) percentage to control the training of patients with dementia is still rare in the~     literature. Therefore, this seems to interfere on the definition of an ideal prescription.~     Following this line of reasoning, the purpose of the present study is to assess the effect~     of moderate aerobic exercise on cognition and functional abilities in AD patients. Design:~     Randomized controlled trial, double-blinded, with 16-week follow-up. Setting: Center for~     Alzheimer's disease in the Institute of Psychiatry of the Federal University of Rio de~     Janeiro. Participants: Elderly with Alzheimer disease. Interventions: The patients will be~     randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and~     moderate intensity of 60% VO2max) and a control group (CG). Main outcome measures: Cognitive~     function will be assessed using CAMCOG, Trail Making Test A, Digit Span, Stroop Test, Rey~     auditory-verbal learning test and Clock Test, and functional capacity will be evaluated~     using Berg Balance Scale (BERG), Sit-to-Stand test (STS), functional reach test (FR), and~     the time to up and go test (TUGT).~   "
117658|NCT01515969|"~     This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib~     together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the~     epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer~     and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which~     may be important to treat lung cancer. The combination of both drugs may work better than~     either drug alone, but may also have increased side effects. This trial will look at the~     side effects of combining the drugs and look for how effective the combination may be.~   "
117659|NCT01515956|"~     This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk~     infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of~     administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome)~     for up to 208 weeks.~   "
117660|NCT01515943|"~     The purpose of this study is to determine the effectiveness of home-based computer therapy~     for symptomatic convergence insufficiency (CI) compared to traditional home-based near~     target push-ups and placebo treatment.~   "
117661|NCT01515930|"~     The purpose of this study is to develop an intervention to increase parental motivation for~     supervision and monitoring youth diabetes care behavior. The intervention will be tested in~     three brief session in conjunction with regularly scheduled diabetes clinic visits and~     delivered through a computer program based in the principles of Motivational Interviewing.~   "
117662|NCT01515917|"~     This is a placebo-controlled study intended to examine the effects of the neutraceutical~     citicholine, together with omega-3 fatty acids, on a range of measures in individuals with~     concussive head injury, often referred to as traumatic brain injury, or TBI. The study will~     consist of three visits, during which participants will complete brain scans, a thorough~     testing battery and a clinical interview to assess mood and other diagnostic information~     relevant to the study.~   "
117663|NCT01515904|"~     In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for~     children and adolescents with severe 'complex' obesity. As part of the program, a subset of~     adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes~     of children and adolescents participating in a 'clinical' setting and even fewer reports of~     outcomes of severely obese pediatric patients. Previously, the investigators evaluated~     clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an~     outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children~     with Central Tumours) and found significant benefit to those attending, including reduction~     of weight gain (or weight loss), improved psychosocial functioning, and increased care~     satisfaction. STOMP is a natural extension of this program, incorporating some core elements~     (e.g., interdisciplinary team, frequent visits, individualized care plans for~     medically-complex adolescents) and building on other aspects, such as increased psychosocial~     intervention; involvement of a key worker (nurse practitioner) to support families;~     provision of continuity of care with other health providers in all settings, community~     services and schools; a more diverse patient population; and group support sessions.~     Evaluation of the outcomes of this clinic is needed to inform best practice for children and~     adolescents with severe complex obesity~   "
117664|NCT01515891|"~     To determine the absorption, metabolism and excretion of BIA 9-1067.~   "
117665|NCT01515878|"~     It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves~     long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and~     by reduced incidence of intradialytic hypotensive episodes~   "
117666|NCT01515865|"~     To study the effect of midodrine against the symptoms of orthostatic hypotension~   "
117667|NCT01515852|"~     Examination of stress level in general anesthesia in comparison to local anesthesia in~     stereotactic biopsy~   "
117668|NCT01515839|"~     The investigators primary objective is to acquire preliminary data on one-hundred former NFL~     veterans with at least one full year of professional service using brain SPECT imaging in~     order to assess the degree to which NFL football puts players at risk for traumatic brain~     injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in~     neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house~     proprietary database comprised of the brains of healthy subjects.~      The investigators secondary objective is to acquire additional data on these players such~     that investigators may establish causative factors and risks associated with said TBI.~      The investigators tertiary objective is to acquire data on subjects using various mental~     health metrics in order to determine the effects of TBI.~   "
117669|NCT01515826|"~     The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate~     0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%)~     ophthalmic solution in the prevention of postoperative inflammation and infection.~   "
117670|NCT01515813|"~     Since people started taking HIV medications, illnesses related to AIDS have decreased, but~     other serious illnesses like heart disease (heart attacks) and certain kinds of cancer have~     increased. Studies show that HIV causes changes in the lining of the arteries and also~     causes inflammation (irritation) inside the body that may play a role in diseases like heart~     attacks and strokes. The levels of inflammation and artery lining health can also affect how~     well your brain works. These changes cannot be felt, but can be measured. Artery lining~     health can be looked at with a test that uses a blood pressure cuff on your arm to see how~     the artery responds when air is let in and out of the cuff. An ultrasound (machine that uses~     sound waves) is used to look at the artery during the test. This test is called Flow~     Mediated Dilation or FMD for short. Inflammation can be checked with blood tests (blood~     tests that measure this irritation inside the body that you cannot feel). HIV medications~     can improve the artery lining health and can partially lower levels of inflammation in the~     blood; however, these levels of inflammation may not be able to return back to normal.~      Pravastatin sodium is a medication that is approved by the Food and Drug Administration~     (FDA) for treating high cholesterol. Pravastatin sodium has also been able to improve the~     health of the lining of the arteries and lower the level of inflammation in people with~     other diseases, but has not been studied or approved for this purpose in people who have~     HIV. This research study will look at the effects of two types of medications used~     separately or together on the health of the lining of arteries and levels of inflammation in~     the blood: Atripla (a HIV medication) and pravastatin sodium. This study will also look at~     the effects of Atripla and pravastatin sodium on cholesterol levels, tests that measure how~     well you can think and calculate (tests of neurocognitive function), and at the effects of~     Atripla on the levels of pravastatin sodium in the blood.~   "
117671|NCT01515800|"~     RATIONALE: Measuring how text-message affects treatment compliance in women with breast~     cancer may help doctors plan the best treatment.~      PURPOSE: This randomized trial studies how well text-message works in reducing early~     discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer~     who underwent breast surgery.~   "
117672|NCT01515787|"~     The standard treatment for locally advanced rectal cancer involves chemotherapy and~     radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and~     radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a~     standard and important part of treatment for rectal cancer and has been shown to decrease~     the risk of the cancer coming back in the same area in the pelvis, some patients experience~     undesirable side effects from the radiation and there have been important advances in~     chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is~     to compare the effects, both good and bad, of the standard treatment of chemotherapy and~     radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs~     5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard~     treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA~     (Food and Drug Administration) approved and have been used routinely to treat patients with~     advanced colorectal cancer.~   "
117673|NCT01515774|"~     1. In order to observe the benefit, side effects, and patient preference of Mirapex ER~          when used in once-daily (QD) or twice-daily (BID) dosing~        2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER~   "
117674|NCT01515761|"~     The primary objective is to determine if lead positioning in the lateral wall of the left~     ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in~     determining myocardial function and affects the severity of mitral regurgitation.~   "
117675|NCT01515748|"~     Primary Objective:~      - To compare progression free survival (PFS) in the two treatment arms~      Secondary Objectives:~        -  Overall survival (OS)~        -  Postoperative stage and R0 (complete) resection rate~        -  Safety: Toxicities associated with neoadjuvant chemotherapy, surgery,~          morbidity/mortality, toxicity of adjuvant chemotherapy1~   "
117676|NCT01515735|"~     To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with~     pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene~     were analyzed by direct sequencing.~   "
117677|NCT01515722|"~     Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the~     medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to~     improve treatment outcomes~      Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance~     and persistence, thereby can improve the treatment outcomes in conjunction with~     pharmacological therapy in OAB patients~      Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals~   "
117678|NCT01515709|"~     Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems,~     particularly in their legs which makes them more limited in what they can do. The Short~     Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking~     speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg~     function.~      This study aims to evaluate whether the SPPB is comparable with current exercise tests used~     in COPD patients, and whether it is useful in predicting disability, death and health~     resource usage over time.~   "
117734|NCT01514968|"~     This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the~     effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in~     healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive~     a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a~     single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.~   "
117679|NCT01515696|"~     Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can~     be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect~     otherwise radiologically invisible perforations or an insufficient GIT anastomosis after~     surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a~     strong osmotic effect and leads to water influx into the intestine lumen. Thereby the~     peristaltic movement is accelerated and the premature infant excretes stool during the hours~     following application. Therefore Gastrografin might be effective to mobilize meconium from~     small bowel and deep parts of the colon. The investigators hypothesized that enteral~     application of Gastrografin accelerates meconium evacuation in premature infants, and~     thereby enhances feeding tolerance in this population.~   "
117680|NCT01515683|"~     Studies shows that reduced nervousness before anaesthesia may improve a course past~     anaesthesia. Therefore it is interesting to investigate how we can best help patients~     shortly before anaesthesia. A RCT with three intervention arms (with different personal~     support) and a control arm (with usual personal support) is therefore performed.~      Hypothesis: Nervousness is reduced by the new interventions compared to the usual help~     provided.~   "
117681|NCT01515670|"~     The purpose of the study is to determine the influence of preoperative co-morbidity in~     relation to increased length of stay and postoperative complications in patients receiving~     fast-track hip or knee replacement.~   "
117682|NCT01515657|"~     This study will determine if aspirin from PL2200, an investigational product, gets into the~     blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether~     PL2200 is able to prevent blood clots as effectively as these other products, when~     administered to patients with diabetes.~   "
117683|NCT01515644|"~     In this study the effect of Infant formula with added Inulin will be compared with the~     effect of Infant formula without Inulin on the Bifidobacterium level in stool.~      It is expected that drinking Infant formula with added Inulin will result in higher~     beneficial bacteria level in stool compared to an Infant formula without Inulin.~   "
117684|NCT01515631|"~     Patients who have Alagille Syndrome (AGS) also frequently have blockages (or stenoses) of~     their pulmonary arteries. Little is known about the degree or variability of these stenoses,~     or the effect of this disease on the right ventricle (the chamber of the heart which pumps~     blood to the lungs). This study will first quantify and describe pulmonary artery stenosis~     in patients with Alagille Syndrome. The study will also assess the effect of these stenoses~     on the right ventricle. The investigators hope to learn the degree and characteristics of~     pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the~     effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille~     Syndrome. This information is critical in the management of patients with Alagille syndrome,~     as there is currently no data to guide clinicians on the management of pulmonary artery~     stenosis. Furthermore, the information from this study may help physicians manage pulmonary~     artery stenosis in other patients as well.~   "
117685|NCT01515605|"~     Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or~     tissue from patients after kidney transplantation. In the present study the investigators~     examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the~     outcome after transplantation.~      Routine clinical and laboratory data from serum and urine are evaluated at baseline and~     after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation.~     Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes~     (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting~     T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase),~     TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential~     cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15~     (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix~     metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others)~     are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain~     reaction) techniques. Proteomic analysis were performed in plasma and urine samples.~     Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by~     descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or~     Kruskal-Wallis-test and Dunn`s multiple comparison post-test, as appropriate. Associations~     between variables are analyzed using regression analyses. Contingency tables are analyzed~     using Fisher's exact test.~   "
117686|NCT01515592|"~     This trial is conducted in Japan. The aim of this trial is to assess the safety and~     tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.~   "
117687|NCT01515579|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of~     the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7~     (formulation 3).~   "
117688|NCT01515566|"~     The goal of this clinical research study is to learn if fentanyl given under the skin can~     reduce shortness of breath in cancer patients. Researchers also want to learn if it can help~     to improve your physical function. In this study, fentanyl will be compared to a placebo.~      Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with~     their shortness of breath as well.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
117689|NCT01515553|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of~     the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation~     planned for phase 3b trials (final formulation 4).~   "
117690|NCT01515540|"~     The investigators tested whether pain decrease can be observed centrally with non-invasive~     brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of~     5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects~     of Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before~     treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double~     blind, placebo controlled trial, where participants either received Lidoderm or placebo~     patches, without cross over.~   "
118245|NCT01508195|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of the FDC tablets (canagliflozin and metformin IR).~   "
117691|NCT01515527|"~     The goal of this clinical research study is to learn if cladribine given in combination with~     low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML~     or MDS. The safety of this drug combination will also be studied.~      Cladribine is designed to interfere with the cell's ability to process DNA (the genetic~     material of cells). It can also insert itself into the DNA of cancer cells to stop them from~     growing and repairing themselves.~      Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing~     and repairing themselves.~      Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.~   "
117692|NCT01515514|"~     The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached~     to endoscope in comparison to standard free-hand image acquisition.~   "
117693|NCT01515501|"~     Patients undergoing routine rectal suction biopsy will undergo as part of the study an~     additional Endoscopic mucosal resection. The biopsy results will also be correlated with~     patient's clinical data including clinical history, Bristol stool scale, anorectal manometry~     results, and SITZ marker studies. Cost and recovery time will be compared.~   "
117694|NCT01515488|"~     An audio-assisted self-triage kiosk in the Pediatric Emergency Department (ED) is expected~     to significantly reduce triage times, without any sacrifice of the quality of information~     that would be obtained by nurse-initiated triage.~   "
117695|NCT01515475|"~     The purpose of this study is to compare visual acuity outcomes and development of strabismus~     after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia~     (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or~     only after confirmation of pre-specified deterioration criteria.~   "
117696|NCT01515462|"~     This is phase I/II protocol to evaluate the safety and efficacy of WAS gene transfer into~     hematopoietic stem/progenitor cells for the treatment of Wiskott Aldrich Syndrome.~   "
117697|NCT01515449|"~     The aim of the project is to ascertain the pre and intra operative predictors of poor~     outcomes in total knee replacement.~   "
117698|NCT01515436|"~     The purpose of this study is to determine if having children listen to the music of Wolfgang~     Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike~     discharges on his/her Electroencephalography (EEG). These spike discharges often occur~     during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with~     Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the~     amount of spike discharges after listening to Mozart's music, this information may lead to~     new understanding and possible treatments for epilepsy.~   "
117699|NCT01515423|"~     The purpose of this study is to demonstrate that a paliperidone palmitate 3 month~     formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M)~     in the treatment of patients with schizophrenia who have been stabilized on PP1M.~   "
117700|NCT01515410|"~     The primary objective of this study is to explore the efficacy and tolerability of DM-1992~     compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR)~     as measured by:~        -  ON time with no dyskinesia or non-troublesome dyskinesia~        -  OFF time~   "
117701|NCT01515397|"~     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.~     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital~     functions. To achieve this, different plasma substitutes are available: Albumin, dextran,~     hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base~     alterations during elective abdominal surgery can be reduced by the use of a new gelatine~     solution.~   "
117702|NCT01515384|"~     The purpose of this study is to evaluate the safety and pancreas imaging properties of~     18F-AV-133.~   "
117703|NCT01515371|"~     The purpose of this study is to identify out of up to three doses a safe and effective dose~     of Botulinum toxin type A for an injection into one side of the soft palate to treat~     snoring.~   "
117704|NCT01515358|"~     The purposes of this study are to determine the safety and side effects of LY3000328, to~     determine how well the body will tolerate LY3000328, and to determine how long LY3000328~     remains in the body.~   "
117705|NCT01515345|"~     The purpose of this study is to determine the efficacy and safety of a routine~     individualized antiplatelet therapy after coronary stent implantation by evaluating~     on-treatment platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate®~     Analyzer).~   "
117706|NCT01515332|"~     This study is simply to test the repeatability of the indirect calorimetry instrument the~     investigators use for our clinical studies.~   "
117707|NCT01515319|"~     Obesity causes 600 premature deaths per week in the UK and existing treatments are not~     effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream~     which make people feel full and which stop eating. One of these chemicals is known as~     Peptide YY (PYY). The investigators have previously shown that injections of PYY reduce~     appetite and food intake in human volunteers. The investigators have now developed a very~     similar chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has~     been shown to be safe, to reduce their appetite, and to last for much longer than PYY~     itself. This study will test Y242 to ensure that it is well tolerated in humans, and to see~     how long it lasts in the blood stream after being injected under the skin. It will also look~     for any effects on appetite.~   "
117708|NCT01515306|"~     The purpose of this study is to investigate whether there are no clinically significant~     pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by~     investigating the pharmacokinetics (PK) of each in participants with advanced malignant~     solid tumors.~      Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B)~     to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the~     pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.~   "
117709|NCT01515293|"~     The aim of this study is to compare the short-term outcomes of single-incision and~     conventional laparoscopic appendectomy.~   "
117735|NCT01514955|"~     Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant~     metastasis is quiet rare, increasing local control in the pelvis can directly translate into~     improvement in survival. Obstacles in front of this approach is the dose limitation to~     normal organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and~     Brachytherapy will grant safe delivery of more conformal higher doses of radiation to the~     tumor and allowing sparing of the normal structures.~   "
117710|NCT01515280|"~     The aim of this study is to have those patients taking part in the Clinical trial-: A~     Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of~     Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire~     (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment~     period. The investigators hope to demonstrate a clinically significant change in HARQ scores~     of at least 16 points from before and after treatment. Furthermore the investigators would~     hope to show a significantly improved HARQ score in patients on the BC036 arm of the study~     compared to the placebo arm.~   "
117711|NCT01515267|"~     Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination~     either by visual estimation (eyeballing) requiring high level of training and expertise~     and/or by manual tracing of the endocard from which EF is calculated (manual biplane method~     (MBP)). This procedure is subjective and time consuming. The objective of this study is to~     compare the performance of LVivoEF software system to the measurements obtained by the~     routinely used methods.~   "
117712|NCT01515254|"~     In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a~     tool to prevent obesity in young children. The purpose of the intervention is to improving~     caregiver feeding practices, child eating behaviors, and child self-regulation of energy~     intake in the short term.~   "
117713|NCT01515241|"~     Despite the availability of several classes of very effective drugs available to treat~     heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need~     for new, effective and well tolerated therapies. There are a number of therapies given on a~     chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty~     acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs,~     but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for~     cardiovascular events. There is still a need for acute therapies that can lead to rapid~     pacification of unstable plaque in order to reduce the risk of these events. This study will~     assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of~     atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and~     intravascular ultrasound (IVUS) evaluations in patients with HeFH.~   "
117714|NCT01515228|"~     The purpose of this study is to examine the safety and effectiveness of coronary stenting~     with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic~     patients.~   "
117715|NCT01515215|"~     Major Depressive Disorder (MDD) is one of the most prevalent mental illnesses in North~     America, in which 30% - 40% fail to respond to conventional treatment. Repetitive~     Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool~     for the treatment of MDD. This form of treatment involves a series of magnetic pulses~     directed to the brain for about 30 minutes. Importantly, such treatment is very safe and~     well tolerated. However, to date, most treatment studies show modest efficacy due to~     limitations, including: 1) treatments that are delivered to only one side of the brain; 2)~     treatment that does not directly target a specific brain region associated with depression;~     3) treatments that are of short duration; 4) treatments that are of insufficient intensity;~     and 5) insufficient understanding of the brain mechanisms responsible for therapeutic~     effect. This study is designed to directly address all of these limitations, as well as~     explore brain mechanisms (e.g. cortical excitability) through which treatment is optimized.~   "
117716|NCT01515202|"~     The purpose of this clinical study is to assess the safety and tolerability of multiple oral~     doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes~     Mellitus.~   "
117717|NCT01515189|"~     The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg~     will extend the lives of subjects with unresectable or metastatic melanoma more than giving~     Ipilimumab at a dose of 3 mg/kg~   "
117718|NCT01515176|"~     This phase I/II trial studies the side effects and the best dose of ofatumumab and~     dinaciclib and to see how well they work in treating patients with relapsed or refractory~     chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia.~     Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them.~     Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.~   "
117719|NCT01515163|"~     The investigators hypothesize that a three-month aerobic exercise training program will~     positively affect the lipid profile, insulin sensitivity , cytokine profile, the~     cardiovascular parameters and muscle strength in SLE patients.~   "
117720|NCT01515150|"~     Previous multicentre study NCT 01008488 indicates that a patient with CT-proven~     uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications~     such as perforations or abscesses. The question is whether or not hospitalization is~     necessary, and if patients in that case could return home without antibiotics.~      The purpose of this study is to evaluate if out-patients managements in uncomplicated~     colonic diverticulitis is possible without readmission or complications.~   "
117721|NCT01515137|"~     This trial was originally designed and powered to compare biomarker modulation in the~     neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical~     response to erlotinib in the adjuvant setting. Since implementing the trial in late 2005,~     The investigators have encountered significant obstacles to implementing the adjuvant~     therapy phase of the trial.~        -  Barriers included:~             1. disease recurrence~             2. patient refusal to take the agent~             3. patient refusal to travel to Pittsburgh for clinical evaluations.~      Given the institutional challenges to implement and complete the adjuvant portion, the~     investigators have decided to change the primary endpoint to a biomarker modulation~     endpoint. To achieve this goal, the investigators determined that they needed 39 paired~     tissue specimens (see statistical justification below).~      The central hypothesis to be tested in this study is that persistent activation of parallel~     and/or downstream pathways contributes to tumor progression in the setting of EGFR blockade.~     While not all head and neck squamous cell carcinoma (HNSCC) patients will respond to EGFR~     targeting, the optimal strategy to identify those subjects whose tumors are sensitive to~     EGFR inhibition remains unknown.~      The primary objective is centered around the concept of tumor biomarkers which may be~     modulated by EGFR and Cox-2 inhibitors and may serve as future therapeutic targets for~     therapy. To this end patients on this trial will be randomly assigned to one of three arms~     to receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative~     period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and~     again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative~     period, for group differences, for treatment effects and for further understanding of~     protein signaling pathways.~      Sample size for the primary objective~      Modification of Statistical Design:~      The primary endpoint is the difference between pre (biopsy) and post (surgery). There are 3~     hypotheses of interest: (1) placebo vs erlotinib alone, (2) placebo versus erlotinib plus~     sulindac, and (3) erlotinib vs erlotinib + sulindac. With a randomization in a 3:5:5 ratio,~     we have 88% power, alpha = .01 for an omnibus test to show between-group differences of 1~     log exist. This requires 39 patients. Basically, 39 patients will provide the ability to~     detect a one log difference between any 2 of the 3 groups in pre-post change.~   "
117722|NCT01515124|"~     WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer~     survivors who are overweight or obese with breast cancer related lymphedema. There will be~     four groups in this trial: exercise only, weight loss only, exercise and weight-loss~     combined, and a control group. The purpose of this study is to test the effects of these~     interventions on lymphedema outcomes, breast cancer recurrence and quality of life.~      The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER~     Survivor interventions and also model the impact of the WISER Survivor interventions over an~     extended time frame.~   "
117723|NCT01515111|"~     A national cross-sectional survey was conducted to evaluate recommendations on clinical~     preventive services and additional information on non-communicable disease prevention.~     Trained surveyors interviewed interns, residents and attendings of the Internal Medicine~     departments of all teaching hospitals in Guatemala. Analysis compared recommendation~     practices within and between hospitals.~   "
117724|NCT01515098|"~     Purpose: The purpose of this study is to examine the effect of blueberry consumption on~     cognitive decline and body composition in humans.~      Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an~     improvement in cognitive abilities as measured by a standardized battery of tests, relative~     to those who consume a placebo.~      Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an~     increase in processing speed and an improvement in memory abilities as measured in an~     electrophysiological paradigm and compared to those who consume a placebo.~      Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition~     (fat mass vs. lean mass).~      Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress~     and inflammatory markers.~   "
117725|NCT01515085|"~     Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or~     radiation give patients a beneficial increase in overall survival? Laser induced thermal~     therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of~     heat.~   "
117726|NCT01515072|"~     The purpose of this study is to determine whether application of lower limb remote ischemic~     preconditioning (RIPC) after determination of brain death improves donor stability, organ~     quality, organ yield, and early post transplant clinical outcomes.~      Neurological death donors will be stratified into standard and extended criteria donors~     (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is~     the number of organs recovered per donor. Secondary outcomes include donor hemodynamic~     state, donor organ-specific function parameters, pulsatile perfusion parameters, number of~     organs transplanted per donor, recipient hospital free survival and delayed graft function~     of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.~   "
117727|NCT01515059|"~     It is well established that bariatric (weightloss) surgery affords considerable improvement~     in glycaemic control (control of blood sugar), and in many cases may lead to a complete~     resolution of type 2 diabetes. However, the mechanisms underlying these changes are yet to~     be elucidated and no research project to date has attempted to characterise changes in~     glycaemic control sooner than 3 days post surgery.~      The primary objective of this study is to characterise changes in glycaemic control in~     individuals immediately following such surgery for a period of five days. Participants will~     be fitted with a continuous blood glucose measurement system (CGMS) prior to leaving~     theatre, which electronically records their blood glucose concentration every minute for up~     to five days. Upon returning the device each participant will undergo a standard meal test~     and have a small blood sample taken at 30 minute intervals (0-120 minutes) for the~     quantification of incretins (gut hormones involved in medium term control of blood sugar)~     insulin, glucose and appetite hormones.~      These measurements will be compared to those collected at the baseline session, three weeks~     prior to the patient's surgery. Additional baseline visit measurements include: fasting~     lipid profile, insulin concentration, blood glucose concentration, HBA1C (long term blood~     glucose measurement), blood pressure, height, weight, waist circumference, and an oral~     glucose tolerance test (OGTT) and medical and family history.~      All patients will be followed up twelve weeks post surgery, during which, all baseline~     measurements will be repeated.~   "
117728|NCT01515046|"~     This is a phase II study. It is designed to provide information about if high-dose ascorbate~     (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that~     vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening~     survival time for patients with advanced pancreatic cancer.~   "
117729|NCT01515033|"~     The purpose of the present study was to evaluate: 1) the effects of continuous exercise~     training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2)~     response during graded exercise test in patients with coronary artery disease; and 2)~     examine the effects of exercise training modalities on the association among PETCO2 at~     ventilatory anaerobic threshold (VAT) and indicators of ventilatory efficiency and~     cardiorespiratory fitness in patients with coronary artery disease.~   "
117730|NCT01515020|"~     Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia~     due to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients~     whose blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would~     improve treatment safety.~      Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of~     daptomycin versus vancomycin would increase by 15% the proportion of patients with~     sterilized blood cultures at 72 hours and would increase the treatment safety.~      Primary objective: To study the efficacy of daptomycin compared to vancomycin on the~     sterilization of blood cultures after 72 hours of therapy.~   "
117731|NCT01515007|"~     The DRCFI treatment will influence the time to first pulmonary exacerbation compared to~     placebo.~   "
117732|NCT01514994|"~     The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two~     phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty~     Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.~   "
117733|NCT01514981|"~     The purpose of this study is to determine that no significant safety issues will be~     identified following a single dose of AMG 761 in asthma subjects that would preclude further~     development of AMG 761.~   "
118246|NCT01508182|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of the FDC tablets (canagliflozin and metformin IR).~   "
117736|NCT01514942|"~     Insulin resistance has important implications in the pathogenesis of the polycystic ovary~     syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.~      Reduction of insulin levels with administration of insulin sensitizing agents has been found~     to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring~     ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely~     used in the long term treatment of women with PCOS in whom it modifies the ovarian~     morphology, improves intraovarian androgen levels, and enhances systemic and local insulin~     resistance. Despite to these beneficial effects, several side effects have been reported due~     to the long term administration of this drug.~      In the recent years, inositol has found more and more space in the reproductive clinical~     practice. Indeed, inositol have been classified as insulin sensitizing agent and it is~     mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in~     particular several studies on Myo-inositol and D-chiro-inositol were reported.~      In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in~     women with PCOS and with or without insulin resistance.~   "
117737|NCT01514929|"~     The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the~     QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase~     in the QT interval.~   "
117738|NCT01514916|"~     The medical device Vascular Join represents a new anastomotic technology that should~     reduce the inter-surgeons variability in anastomosis construction and increase the~     performances in terms of results. It allows a perfect mechanical anastomosis without suture,~     avoiding the disadvantages of operation length and difficulty of the act, thrombosis,~     clamping and embolism. The Vascular Join creates automatically the connection between the~     vein or prosthesis at both ends and bridging the artery while preventing the passage of the~     needle and suture through the vessel wall and clamping pressure. This makes it very easy to~     construct a vascular anastomosis using the endoscopic technique less traumatic for the~     patient, lessen the pain of the patient, thereby reducing health care costs by reducing the~     length of hospital stay.~      No part of the device is in contact with the patient's blood because the whole system~     remains in the thickness of the arterial wall and outside the vessel. Thus, the formation of~     intimal hyperplasia is greatly diminished and the risk of occlusion of the anastomosis is~     less than the currently available risk when a suture is used. This risk is shown by studies~     on animals in labs, with a mean follow up of 12 months. The Vascular Join creates a perfect~     congruence of anastomosed vessels because it allows a perfect match between each vascular~     tunic.~      The medical device Vascular Join has been designed in order to:~        -  Reduce the suture time;~        -  Reduce the risk of occlusion of vein after the surgical process;~        -  Avoid the contact risk between the external material steel (surgical needle) and blood;~        -  Standardize the quality of anastomoses independently of the skill of the surgeon.~   "
117739|NCT01514903|"~     This is a single dose open-label comparative pharmacokinetic study to assess the~     pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra~     (tablet) in healthy male subjects.~   "
117740|NCT01514890|"~     The purpose fo the study is to evaluate the efficacy defined by the sustained virological~     response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and~     telaprevir or boceprevir in the French Early Access Program for the use of protease~     inhibitors or after the approval of these drugs through the the marketing authorization.~   "
117741|NCT01514877|"~     The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT~     in treating patients with multiple brain metastases from NSCLC.~   "
117742|NCT01514864|"~     The purpose of this study is to establish whether patients with malignancy harboring a~     discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to~     dasatinib.~   "
117743|NCT01514851|"~     To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum~     Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized,~     double-blind, parallel group study in comparison with Calcium carbonate.~   "
117744|NCT01514838|"~     The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C~     as well as its safety in Asian subjects with type 2 diabetes mellitus.~   "
117745|NCT01514825|"~     The purpose of this study is to evaluate the safety and plasma concentration change of YM150~     after repeated administration to healthy elderly male and female subjects.~   "
117746|NCT01514812|"~     This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in~     healthy subjects.~   "
117747|NCT01514799|"~     Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is~     not always enough. Bypassing a longer segment of the gut may be more beneficial. Which part~     to bypass is not clear.~      The investigators want to compare the effects between preventing a proximal (oral) portion~     of the jejunum from food contact with the effects when preventing the jejunum from contact~     with bile and pancreatic juice.~      Endpoints are quality of life, gstrointestinal function, and weight development.~   "
117748|NCT01514786|"~     Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of~     multiple competing demands. A decision aid (DA) that clarifies patient preferences and~     improves decision quality could aid shared decision making (SDM) and be effective at~     increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year~     R01 study funded by the National Cancer Institute seeks to provide detailed understanding of~     how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS~     adherence.~   "
117749|NCT01514773|"~     To better understand the reasons for underutilization of defibrillator therapy in selected~     populations, the investigators propose a study to assess heart failure patient knowledge and~     attitudes toward device therapy. By carefully studying populations of patients with systolic~     heart failure, the investigators aim to identify the underlying reasons for implantable~     cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic~     heart failure.~   "
117761|NCT01514617|"~     It is known that volumetric response of leiomyomas following uterine artery embolization~     correlates well with patients clinical outcome. The aim of this study is to assess diffusion~     -and perfusion weighted MRI for the prediction of volumetric response following uterine~     artery embolization in patients with symptomatic leiomyomas.~   "
117750|NCT01514760|"~     Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and~     University of Arkansas for Medical Sciences Center for Distance Health will collaborate to~     develop a mobile-based Asthma Action Plan application to improve asthma self-management~     skills specifically targeting adolescents. The investigators hypothesize that an~     interactive, mobile-based asthma action plan will be a feasible means of reinforcing~     long-term asthma management guidelines as well as delivering acute management instructions~     to adolescents with asthma.~   "
117751|NCT01514747|"~     Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the~     US. These babies often have motor and/or visual problems when they grow up. It is very~     important to identify high risk ELBW infants as early as possible, so that the investigators~     can treat them earlier to prevent poor development. Neurological examination at early age is~     not good enough to identify high risk ELBW infants. One the other hand, some magnetic~     resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state~     functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor~     and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW~     infants at a very early age to predict long−term outcome and to identify infants who are at~     high risk of having motor and/or visual problems when they grow up.~   "
117752|NCT01514734|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular~     hypertension.~   "
117753|NCT01514721|"~     The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav®~     (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination~     pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with~     uncontrolled intraocular pressure (IOP).~   "
117754|NCT01514708|"~     The purpose of this study is to evaluate the antibody response to the influenza vaccine~     (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization~     in pregnant women in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.~   "
117755|NCT01514695|"~     The purpose of this study is to determine whether conscious sedation with a narcotic and~     sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy~     to achieve optimal patient comfort and ease of procedure.~   "
117756|NCT01514682|"~     Despite current antipsychotic treatment, the majority of people with schizophrenia continue~     to exhibit persistent positive and negative symptoms and cognitive impairments. An~     alternative approach to the use of psychotropic agents for the treatment of persistent~     symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state~     hypothesized to underlie the symptom and sign manifestations of the illness.~      The investigators primary hypothesis is that add-on anti-inflammatory combination therapy~     will have significant beneficial effects on persistent positive symptoms and cognitive~     impairments.~      The investigators secondary hypotheses are:~        1. add-on anti-inflammatory combination therapy will be associated with improvements in~          depressive and negative symptoms and a reduction in pro-inflammatory cytokines~        2. add-on anti-inflammatory combination therapy compared to placebo will not be associated~          with elevated adverse risk.~   "
117757|NCT01514669|"~     The purpose of this research study is to compare profiles in the blood and tears of patients~     with and without prostate cancer with the goal of developing a method of separating men with~     aggressive and non-aggressive disease.~   "
117758|NCT01514656|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival~     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than~     one third of witnessed SCA events. A number of barriers to bystander CPR training have been~     identified including time and cost of the training course. Since the large majority of~     arrest events occur in the home environment, studies have suggested that providing CPR~     training to family members of hospitalized cardiac patients may serve as a useful approach~     to address an environment in which bystander CPR is frequently not provided. Utilizing an~     existing in-hospital program to train adult family members, the investigators will assess~     the skills of those who learn CPR through two different education methods (video-only and~     video self-instruction (VSI) kit).~   "
117759|NCT01514643|"~     The purpose of the study is to investigate a relationship between the inflammatory response~     following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan~     to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum~     in patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial~     fluid and blood serum in patients who sustain an intraarticular tibial plafond fracture.~     This information will be combined with radiographs and patient outcome measures to determine~     a correlation between intraarticular inflammatory response and post-traumatic~     osteoarthritis.~   "
117760|NCT01514630|"~     Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked,~     snorted, injected or ingested orally to produce a release of high levels of dopamine into~     the brain and reduction of dopamine uptake. Its use results in feelings of pleasure,~     increased energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey~     on Drug Use and Health reported that 353,000 Americans aged 12 or older reported being~     current MA users. Over the past decade MA use rates have fluctuated with current use rates~     on the decline; however, importantly, even though overall use rates are declining, use rates~     among males and females are approaching equal proportions. This use rate pattern is unlike~     other drugs of abuse, which typically demonstrate males using more than females. In some~     states, more females than males consider MA as their drug of choice. Namely, in a 2010~     report in the state of Utah, more females were diagnosed with MA as a primary substance of~     abuse than males upon admission to treatment.~      Depression and MA use are highly comorbid. The relationship between MA use and depression is~     likely bidirectional, with MA use causing changes in mood and being used as a~     self-medicating behavior to reduce symptoms of depression. Several studies have shown that~     depression rates are higher in MA-using females compared to their male counterparts. It is~     likely that neurobiological and psychosocial mechanisms contribute to increased incidence of~     depressive symptoms in females.~      No clear treatment model exists to suggest how the comorbidity of depression and MA use is~     best managed. In studies of antidepressants for treatment of MA withdrawal and dependence,~     findings have suggested that antidepressants are ineffective for treating depressive~     symptoms.~      Creatine is an organic acid occurring naturally in vertebrates, where it takes part in~     energy homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been~     shown to increase brain concentrations of PCr. Neuroimaging studies of creatine have shown~     increased brain phosphocreatine (PCr) content with creatine administration. Therefore, we~     hypothesize that oral creatine administration will increase PCr levels and reduce depressive~     symptoms in a sample of depressed female MA users. This hypothesis will be tested by a~     within subjects design by giving depressed MA using females oral creatine for eight weeks~     and measuring PCr pre- and post-treatment with magnetic resonance spectroscopy. Moreover,~     depressive symptoms will be measured by administration of the Hamilton Depression Rating~     Scale twice weekly during the course of creatine treatment.~   "
117762|NCT01514604|"~     Constructing a learning curve in ultrasound guided needling~      Observational study - How many attempts, with continuous training and feedback, at in-plane~     ultrasound guided needling in a phantom model are required to attain competence?~      The use of ultrasound to enable real-time needle visualisation during regional anaesthesia~     (placing local anaesthetic, via a needle, near nerves to result in numbing of an area of the~     body to be operated on) has gained in popularity in recent years. It has been recognised by~     NICE (National Institute for Clinical Excellence) and guidelines on training have been~     published, with UK equivalents pending. These call for training in the technique on models~     or 'phantoms' prior to patient contact.~      It is unknown how much experience is necessary to attain competence in a phantom, prior to~     proceeding to patient contact. One study looking at experiential learning of the technique~     found a very wide range of experience needed between individuals.~      In order to study the effect of any changes in training methods on the learning of the~     technique it is necessary to have a baseline learning curve.~      The investigators are introducing a training package for anaesthetists new to the technique~     to meet the recommendations on initial phantom based training. Alongside this the~     investigators aim to gather prospective observational data allowing the investigators to~     generate a learning curve for the technique. This involves making a video recording of the~     ultrasound images of approximately 50 sequential attempts at performing a task in a phantom,~     with ongoing instruction and coaching. The whole training package will take approximately 1~     hour.~      These video clips will be reviewed and sequential attempts graded for quality of needle~     visualisation and task completion. This will allow the investigators to use a statistical~     method, Cumulative Sum (Cusum) analysis, to determine how many attempts were required to~     attain proficiency. The investigators hope to recruit approximately 20 participants to this~     pilot study, and from this determine the average amount of training necessary to attain~     proficiency. Using Cusum analysis requires the use of an acceptable failure rate, usually~     chosen arbitrarily. To add greater meaning to our findings the investigators will also~     invite anaesthetists experienced in the technique of in-plane ultrasound guided needling to~     participate. By measuring the actual success rate of our local trainers the investigators~     will be able to make a meaningful comparison of the training required to achieve a similar~     level of success.~   "
117763|NCT01514591|"~     The purpose of the study is to assess the coagulation changes that occur in laboring~     patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography~     (TEG). We will compare coagulation data to assess potential coagulation changes associated~     with hemoglobin changes before and after surgery, and related to estimated blood loss.~   "
117764|NCT01514578|"~     This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception~     and sedation in healthy adult males.~   "
117765|NCT01514565|"~     This is a prospective observational study aimed to validate biomarkers that predict~     response.~   "
117766|NCT01514552|"~     In areas of the world where populations are undernourished poor oral health is prevalent.~     Diets rich in fruit and vegetables are thought to have many health benefits including~     reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries~     contain many different compounds which may be responsible for these proposed health~     benefits.~      From this study, the researchers hope to gain information about how the tissues in the mouth~     absorb strawberry gummies in a population of habitually smoking and never smoking men and~     women. The researchers will measure inflammation hormones in your saliva and urine and the~     genes in your mouth and blood. Two different strawberry gummies will be tested in this~     study. The strawberry gummies were developed at OSU in the Department of Food Science and~     Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while~     the other type will have no fruit. In total the eight pieces of strawberry gummies that you~     will consume in one day will be at most equal to 1 cup of whole strawberries. The research~     team believes the two strawberry gummies may be digested and absorbed differently and that~     components in the strawberry gummies may be helpful for oral health.~   "
117767|NCT01514539|"~     Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies~     suggest that childbearing is an important contributor to the development of obesity in many~     women and that breastfeeding may be protective.~      Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy~     homeostasis and are biological neuroendocrine signals that potentially affect body weight~     and adiposity/~   "
117768|NCT01514526|"~     -  Design: non-randomized, open label, phase II clinical trial.~        -  Study population and disease: adult patients with metastatic or locally advanced~          non-resectable adrenocortical carcinoma, confirmed histologically.~        -  Estimated number of patients: 15.~        -  Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2~          days off.~        -  Treatment duration: study treatment period will be continued until disease progression,~          unacceptable toxicity, death or premature withdrawal from study. An average of 6 months~          treatment period is expected.~        -  Study duration: expected recruitment period will be 18 months, and patients will be~          followed for 6 additional months after last patient is included in the trial.Study~          total expected duration is 24 months.~        -  Sites: the study is planned to be conducted in 7 Spanish centers.~   "
117769|NCT01514513|"~     The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in~     eradicating head lice as compared to Nix, both are available over-the-counter lice~     treatments.~   "
117770|NCT01514500|"~     This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC0195-0092 compared to placebo in healthy~     male subjects.~   "
117771|NCT01514487|"~     This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence~     between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned~     Phase 3 formulation at pH 7.7.~   "
117772|NCT01514461|"~     The purpose of this study is to determine whether LCQ908 is effective and safe in lowering~     triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia~     [HLP] type I). Data from this study will be used to support a registration submission of~     LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).~   "
117773|NCT01514448|"~     Patients with metastatic renal cell carcinoma (mRCC) who have failed first-line therapy with~     sunitinib or pazopanib will be treated with everolimus. Efficacy and safety of everolimus~     will be evaluated in theses patients.~   "
117787|NCT01514266|"~     Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and~     health care use. Diffuse airways inflammation is seen in COPD and is thought to be the~     reason for deterioration of lung function in COPD. Currently there is no medication~     available that can modify or reduce this inflammation. Furthermore, from literature review~     it has been shown that chronic inflammation can result in cancerous changes.~      Curcumin is a food additive used for centuries. Several studies showed that curcumin~     suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b~     are down regulated by this substance. This study was designed to evaluate effect of~     combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is~     double-blind randomized pilot study.~   "
117774|NCT01514435|"~     There exist already a few studies that have measured changes of brain metabolism pre and~     post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were~     all performed in a small number of patients and used different methodologies. It is~     therefore not surprising that these investigations provided inconsistent results, as~     reviewed previously {{23 Schmidt,E.Z. 2008}}.~      In patients with treatment-refractory major depressive episodes, the investigators here~     therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur~     after treatment with ECT and (b) whether these correlate with the clinical amelioration of~     symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive~     function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and~     at the end of treatment.~      Patients with a treatment refractory depression - defined as absent clinical improvement of~     depressive symptoms after at least two trials with antidepressants from different~     pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30~     Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively~     asked for participation in this study. Patients had to be between 18 and 80 years old and to~     be physically healthy.~   "
117775|NCT01514422|"~     The purpose of this study is to evaluate minocycline as a potential treatment for bipolar~     depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is~     approved for the treatment of infections and acne. Participation in this research study is~     expected to last 8 weeks, and includes five outpatient visits.~   "
117776|NCT01514409|"~     5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and~     is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter~     that is involved in the regulation of mood.~      Previous research has assessed the effects of raising serotonin levels using tryptophan (the~     precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy~     volunteers. However, to date there has been no human trial investigating the effects of~     5-HTP on emotional processing in healthy volunteers.~      Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and~     mood in healthy volunteers.~   "
117777|NCT01514396|"~     The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™~     Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound~     closure of the topical skin in children presenting in the Emergency Department (ED).~   "
117778|NCT01514383|"~     The purpose of this study is to evaluate how surgical adhesive is used.~   "
117779|NCT01514370|"~     This is a prospective, monocentric, double blind, placebo controlled, two arm study.~      Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric)~     belonging to the Zingiberaceae family found in South Asian countries, especially India which~     is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil~     to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant~     and anti-inflammatory effects of the standard therapy maintaining a good safety profile.~   "
117780|NCT01514357|"~     The aim of this study is two fold: First the investigators want to determine the safe and~     most effective dose of subcutaneous (SQ) BNP in subjects with resistant hypertension.~     Second, the investigators want to demonstrate efficacy of chronically (one week)~     administered SQ BNP in resistant hypertension in reducing blood pressure.~   "
117781|NCT01514344|"~     Phase II, monocentric, open label study to assess safety and activity of intralesional~     Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.~   "
117782|NCT01514331|"~     The main purpose of this study is to investigate effects of SIMV+VG (synchronized~     intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support~     ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation~     synchrony, ventilation parameters and inflammatory mediators in neonates.~   "
117783|NCT01514318|"~     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes~     data on patients who received the Revelation Hip Stem prior to 2002.~   "
117784|NCT01514305|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4~     System when used as an adjuvant to blood glucose testing.~      Device performance will be primarily evaluated in terms of the proportion of glucose values~     within a pre-specified range compared to reference values.~      Safety data of the G4 System will also be collected vis-a-vis adverse event reporting~     characterized by the incidence and severity of Serious Adverse Device Events, and Adverse~     Device Events experienced by study participants.~   "
117785|NCT01514292|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4~     System when used as an adjuvant to blood glucose testing over a 7-day period in people >18~     years-old with diabetes mellitus.~      The primary objective is to characterize the System performance with respect to laboratory~     reference venous sample measurements. The device performance will be primarily evaluated in~     terms of point and rate accuracy of the G4 System in reference to YSI.~      Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse~     Device Effects experienced by study participants.~   "
117786|NCT01514279|"~     The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health~     (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood~     Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case~     Western Reserve/Cleveland's project is entitled Targeting Obesity and Blood Pressure in~     Urban Youth. The site name is IMPACT (Ideas Moving Parents and Adolescents to Change~     Together).~      The project assesses the effects of three interventions on Body Mass Index(BMI) in~     overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention~     (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only~     intervention (Tools4Change). In addition the study assesses the potential additional impact~     of a school-community based intervention on outcomes.~      The project has two phases: a formative phase (including focus groups and a pilot) and the~     main trial. The main trial will take place over approximately four years.~   "
117788|NCT01514253|"~     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the~     beneficial effects extend to care giving procedures that are performed after painful~     procedures. The investigators objective is to determine the effect of glucose 25% analgesia~     in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a~     subsequent care giving procedure.~   "
117789|NCT01514240|"~     The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily~     compared to Mesalazine 1 g three times a day to patients with mild to moderate active~     Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a~     score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission~     after 8-week treatment defined by a CDAI score of ≤ 150.~   "
117790|NCT01514227|"~     NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet~     Therapy (DAPT) following Nobori stent deployment.~   "
117791|NCT01514214|"~     Strictures in the bile duct cause a blockage of flow of bile. This leads to potential~     problems including jaundice, itch and infection in the bile duct. The usual first step in~     this situation would be to allow flow of bile by placing a stent across the stricture. This~     is usually done by a special type of endoscopy procedure called an endoscopic retrograde~     cholangiopancreatography, or ERCP.~      The most commonly used stent are made from a plastic material called polyethylene and has a~     central lumen in which bile drains through it. Health Canada has approved the sale and use~     of another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct~     strictures and is used routinely in our hospitals. However, the investigators do not know~     which stent is better at treating bile duct strictures. In order to determine which stent~     would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be~     studied under carefully controlled circumstances. This will be done by a randomized,~     subject-blinded study. Other trials in the past have looked at other stents in this way, but~     this is the first time the VIADUCT stent has been looked at in this manner. The~     investigators suspect that the design of the VIADUCT stent will allow it to work for a~     longer period of time compared to the traditional polyethylene stent.~   "
117792|NCT01514201|"~     This phase I/II trial studies the side effects and the best dose of veliparib when given~     together with radiation therapy and temozolomide and to see how well they work in treating~     younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy~     uses high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells either by killing the~     cells or by stopping them from dividing. Giving veliparib with radiation therapy and~     temozolomide may kill more tumor cells.~   "
117793|NCT01514188|"~     This is a phase 2b, randomized, open-label, prospective, multicenter study comparing~     treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or~     unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy~     except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor~     recurrence has occurred for at least 12 months.~   "
117794|NCT01514175|"~     The primary objective of this study is to compare the efficacy of a single dose of~     intravenous ibuprofen compared to a single dose of ketorolac for the treatment of~     postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).~   "
117795|NCT01514162|"~     To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in~     subjects who had a Trifecta valve implanted during the IDE study.~   "
117796|NCT01514149|"~     DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly~     injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin~     monotherapy.~   "
117797|NCT01514136|"~     Coloplast A/S has developed a new ostomy device in 8 versions.~      The primary objective of this investigation is to assess and compare the degree of leakage~     when using the 8 different devices.~      The secondary objective is to investigate several performance and safety parameters of the~     various devices.~      The aim of the primary and secondary objectives is to acquire more knowledge about the~     performance of the newly developed device and inspiration for their further development, if~     needed.~      Given that the investigation is exploratory, pass/fail criteria are not relevant. The~     investigation result will provide knowledge useful for continued decision-making/device~     development.~      The investigation is designed as a non-blinded, controlled, exploratory investigation that~     includes a total of 30-40 Danish ileostomy users.~      Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each~     device will be tested for 7 (± 2) days.~   "
117798|NCT01514123|"~     This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100~     alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study~     in subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the~     safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100~     when administered alone or in combination with bevacizumab.~   "
117799|NCT01514110|"~     The purpose of this study is to determine dose limiting toxicities (DLT) and maximum~     tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.~   "
117800|NCT01514097|"~     Pain is a common cause for children seeking care in the Emergency Department (ED). Children~     with orthopedic injuries often require pain control when seeking emergency care. Despite the~     high prevalence of ED visits requiring pain control, pain is often poorly assessed and~     treated in ED settings. Currently, no standard of care exists for the management of this~     fracture-related pain in children discharged from the ED. Furthermore, discrepancies in~     analgesia administration to patients of various racial groups seeking emergency care have~     been documented but are poorly understood. No research currently exists comparing pain~     severity between upper extremity fractures requiring simple splinting to those treated with~     sedated reduction and splinting. Furthermore, there is no research regarding the prevalence~     of significant post-discharge pain nor the differences among ethnic and age groups treated~     in the ED.~      Research Questions:~      What is the prevalence of significant post-discharge pain in children treated for upper~     extremity fractures?~      Is there a difference in severity between those children requiring reduction versus simple~     splinting?~      Is there a difference in pain severity noted among different ethnic or age groups?~      Design This is a prospective, un-blinded, observational study that will include patients~     seeking treatment for an upper extremity fracture.~   "
117844|NCT01513486|"~     In the present study, the effects of 5 days of lower limb immobilization with or without~     daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics~     will be determined.~   "
118247|NCT01508169|"~     The objective of this study was to determine if foot orthoses are effective in improving~     balance, pain and disability in elderly women with osteoporosis.~   "
117801|NCT01514084|"~     Facial lacerations are commonly treated in the emergency department. The nature of the~     injury leads to a great deal of concern about the long-term cosmetic appearance of the~     wounds.~      Research Questions~        1. What is the association between wound characteristics, wound management in the ED,~          patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured~          wounds?~        2. Is there a difference noted among ED providers with different levels of training?~        3. Is there an association between initial satisfaction scores and wound outcome?~        4. Is there an association between short term and long term wound scores?~      Design This is a non-randomized, prospective, observational study of patients who present to~     the ED seeking treatment for facial laceration repair.~   "
117802|NCT01514071|"~     It is difficult for Pediatric Emergency Department providers to recognize clinically~     significant head injuries that are likely to require neurosurgical intervention or close~     monitoring from those that can be safely discharged.~      Research Question How do a combination of education and an animated picture depicting the~     PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT~     scans?~      Design This is a within subject, repeated measures study design.~   "
117803|NCT01514058|"~     Patients who present with obstructive jaundice due to a malignant stricture often undergo a~     battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde~     cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom~     relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for~     fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not~     available at many centers, patients often undergo an initial ERCP procedure with stent~     placement (which is more widely available) prior to referral for EUS. It has been reported~     that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing,~     and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the~     EUS with FNA procedure may also be compromised in patients with biliary stents. As such,~     diagnosis and treatment options may be delayed. One retrospective study of 65 subjects~     showed a significant difference in the number of correctly staged pancreatic head cancers~     (mainly T stage) in patients without stents versus those with biliary stents (85% vs 47%).2~     A second retrospective study concluded that tissue diagnosis is not influenced in patients~     with stents placed greater than 24 hours before the EUS; however, patients with stents~     placed just prior to the EUS (less than 24 hours) were more likely to have indeterminate~     results.1 Although the findings are suggestive, the studies are limited by their~     retrospective design and these questions have not yet been addressed in a prospective study.~      Both procedures require anesthesia, and when performed sequentially in the same setting, the~     duration of anesthesia is prolonged. This is concerning for the patient since complications~     may theoretically increase with prolonged anesthesia. However, a retrospective review at a~     tertiary referral center showed that combined EUS and ERCP yielded a complication rate no~     higher than that of the component procedures.3~      At our institution, the current practice is to sequentially perform both EUS and ERCP in the~     same setting for patients with suspected malignant biliary obstruction. Typically, EUS-FNA~     is performed first, followed by ERCP.~      Hypothesis We hypothesize that performing ERCP with biliary stenting immediately prior to~     EUS-FNA will decrease the diagnostic yield of EUS-FNA and diminish the ability of EUS to~     accurately stage pancreas tumors. Conversely, performing EUS-FNA prior to ERCP will increase~     biliary cannulation time and increase success rate.~      The objectives of this study are as follows:~        1. Determine the diagnostic yield of EUS-FNA (for diagnosis of cancer vs benign process)~          when performed either immediately before or after ERCP with biliary stenting (primary~          outcome)~        2. Determine the ability of EUS to accurately stage pancreatic masses (T and N staging)~          when performed either immediately before or after ERCP with biliary stenting (secondary~          outcome) in comparison to the gold standard of surgical pathology post resection or in~          comparison to CT findings (in those patients who are not surgical candidates)~        3. Determine the biliary cannulation time (the time it takes to successfully pass a wire~          into the common bile duct from the start of the procedure) and success rate of placing~          a biliary stent during ERCP when performed either immediately before or after EUS-FNA~          (secondary outcome)~   "
117804|NCT01514045|"~     The Gastric Cancer Registry will combine data acquired directly from patients with gastric~     cancer via an online questionnaire with genomic data obtained from blood and tissue samples.~     The purpose of this registry is to gain better understanding of the causes of gastric~     cancer, both environmental and genetic; whether certain genomic data can predict outcomes of~     treatment and survival; as well as explore the issues that effect the quality of life of~     these patients after diagnosis and treatment.~   "
117805|NCT01514032|"~     The purpose of this study is to compare two established modalities for the treatment of~     kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with~     stone-extraction). Comparison of the stone-free rates 3month postoperative.~        -  Trial with surgical intervention~   "
117806|NCT01514019|"~     An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the~     effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and~     pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers~   "
117807|NCT01514006|"~     The purpose of this study is to evaluate the possible association between postoperative~     anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.~      The investigators hypothesise that patients with a higher degree of postoperative anaemia~     have impaired postoperative rehabilitation as measured by standardized functional outcome~     tests.~   "
117808|NCT01513993|"~     The purpose of this study is to evaluate whether telemonitoring of patients with chronic~     heart failure produces a reduction in the combined end point of all cause mortality and~     number of hospitalisations, and whether it improves health related quality of life. In~     addition, the trials evaluate the economic and organisational impact of the telemonitoring~     service and examine its acceptability by patients and health professionals.~   "
117809|NCT01513980|"~     The purpose of this study is to evaluate whether the introduction of large-scale~     telemonitoring of patients with COPD produces benefits in terms of improved health-related~     quality of life and reduced access to hospital facilities. In addition, the trial evaluates~     the economic and organisational impact of the new services, and examine their acceptability~     by patients and health professionals.~   "
117810|NCT01513967|"~     This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to~     investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The~     study will be divided into three parts: A, B, and C~   "
117811|NCT01513954|"~     The purpose of this study is to determine whether progesterone hormone levels differ~     following egg retrieval with a single lumen needle compared with a double lumen needle.~     These levels will be measured on several days before and after egg retrieval. The~     progesterone levels in each IVF group will also be compared to the group of women who are~     having IUI. In addition, these progesterone levels will be correlated with pregnancy~     outcomes.~   "
117812|NCT01513941|"~     The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given~     with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of~     hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human~     immunodeficiency virus (HIV-1).~   "
117813|NCT01513928|"~     This study is designed to compare the pharmacokinetics of three different formulations of~     Pf-04937319~   "
117814|NCT01513915|"~     The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention~     for children with anxiety disorders (AD) is undeniable. However, most children with AD have~     limited access to CBT. There is some controversial evidence on group CBT in AD involving~     families in treatment of their children and a published article on efficacy of a parent only~     group CBT for these children. Considering these data, the investigators hypothesized that~     teaching anxiety-fighting skills to parents of children with AD would diminish anxiety~     symptoms of both parents and children and improve family relational functioning.~   "
117815|NCT01513902|"~     Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less~     than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).~   "
117816|NCT01513863|"~     The objective of this study is to demonstrate that metronidazole 1% topical gel is effective~     for the treatment of patients with moderate to severe rosacea.~   "
117817|NCT01513850|"~     The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a~     study drug) after liver transplantation.~   "
117818|NCT01513837|"~     Based on the evidence for the common pathway in asthma presentation, our working~     hypothesis is that asthma severity and lack of control are related to the prevalence and~     severity of nasal and sinusal inflammatory pathology, and especially to chronic~     rhinosinusitis with nasal polyps.~   "
117819|NCT01513824|"~     The purpose of the study is to examine if bio feedback guided stress management by daily~     measurement of pressure pain sensitivity followed by acupressure reduces signs of depression~     and number clinical stress signs and increases quality of life in patients with stable,~     ischemic heart disease~   "
117845|NCT01513473|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of this trial is to investigate the efficacy and safety of insulin degludec in~     children and adolescents with type 1 diabetes mellitus.~   "
117820|NCT01513811|"~     Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene~     glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However,~     a significant number of patients, especially those constipated patients, failed~     colonoscopies due to poor bowel cleaning. Inadequate preparation may also lead to missed~     colonic lesions. The study is based on the hypothesis: itopride hydrochloride, a prokinetic~     agent, its dual role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition~     make it an appropriate adjuvant for bowel preparation. It was reported to promote colonic~     peristalsis, shorten colonic transit time and accelerate propulsion of colonic luminal~     contents through inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo.~     So this study is to determine the efficacy, tolerance and safety of high dose of itopride,~     when given in different times before administration of PEG-E, for colonic preparation in~     patients with chronic constipation.~   "
117821|NCT01513798|"~     The investigators investigate if combined progressive aerobic training and resistance~     training improve metabolic control and fat mass in patients with type 2 diabetes who are~     eating a modified paleolithic diet. The investigators randomize 40 participants to two~     groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2)~     Modified paleolithic diet and general advice about exercise.~      The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat~     mass more with progressive exercise under observation and a modified paleolithic diet than~     with general advice about exercise and a modified paleolithic diet.~   "
117822|NCT01513785|"~     The efficacy of traditional triple therapy has been decreased to such an unacceptable level~     as 70% in many areas. The study is based on the hypothesis: the most important factors which~     influence the effect of Helicobacter pylori (H. pylori) eradication included acid~     suppression intensity and sensitivity of antibiotics. So the investigators chose dual~     therapy because it is simple and verified to be useful. Rabeprazole, as a new proton pump~     inhibitor (PPI), is reported to be less susceptible to the influence of genetic~     polymorphisms for CYP2C19. So it has a greater and faster acid suppression effect compared~     to other PPIs. Amoxicillin is one of effective antibiotics to H. pylori with few side~     effects. The antibiotic resistance of Amoxicillin is no more than 3% in China. The purpose~     of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens~     with different doses of Rabeprazole for initial treatment of H. pylori infection.~   "
117823|NCT01513772|"~     The investigators examined the effect of dexmedetomidine on the emergence agitation and~     postoperative quality of recovery in nasal surgery~   "
117824|NCT01513759|"~     The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when~     used in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE)~     will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or~     submassive PE.~   "
117825|NCT01513746|"~     The purpose of the study is to investigate how people with type 1 diabetes experience and~     manage their diabetes, eating, and weight. Summary of the Study: If you choose to~     participate, you will complete a set of questionnaires and a structured interview. You will~     then wear a continuous glucose monitor and use your cell phone to answer study questions for~     a period of 3 days. The questions come in the form of regular phone calls between the hours~     of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also~     be asked to call in and answer study questions at other times during the day, especially~     after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live~     greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype.~     Participants will receive and return study materials through the mail.~   "
117826|NCT01513733|"~     The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel~     is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies,~     cabazitaxel and prednisone has become a standard second line chemotherapy regimen and~     becomes the backbone upon which to improve upon. Thus, the primary objective of this study~     is to determine the recommended dose of tasquinimod in combination with cabazitaxel and~     prednisone based on safety and tolerability in men with chemorefractory metastatic~     castration-resistant prostate cancer (CRPC).~   "
117827|NCT01513720|"~     This is an single dose,two-way, crossover, oral bioequivalence study.~   "
117828|NCT01513707|"~     This is a prospective, multicenter, comparative, parallel-group, observational study. There~     will be 2 cohorts according to pre-transplant dialysis modality (hemodialysis or peritoneal~     dialysis). In each cohort, subjects will be observed for 12 months. Approximately, 1040~     subjects will be enrolled from 8 transplant centers.~      Subjects will be enrolled consecutively until the number of subjects in peritoneal dialysis~     group has been 260. It will take 2 years. In this period, the number of subject in~     hemodialysis group enrolled in this study will be 780. After finishing the observation of~     all subjects, to balance clinical and demographic baseline characteristics between the two~     groups, subjects will be selected in each cohort with 1:1 matched using propensity score~     method. And then primary and secondary endpoints will be compared between two groups.~   "
117829|NCT01513694|"~     The purpose of this trial is to test the effectiveness of the use of a new therapeutic~     strategy in treating patients with degenerative disc disease lumbar intervertebral fusion~     with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium~     phosphate ceramic (Conduit TM).~   "
117830|NCT01513681|"~     This is an single dose,two-way, crossover, oral bioequivalence study.~   "
117831|NCT01513668|"~     The purpose of this study is to compare single-dose oral bioavailability of acetaminophen~     650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA~     (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650~     mg) of Mc Neil, Consumer & Specialty Pharmaceuticals, U.S.A in healthy, adult, male human~     subjects under fed condition.~   "
117846|NCT01513460|"~     This study will assess the efficacy, tolerability and safety of NVA237 compared to~     tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive~     pulmonary disease.~   "
117874|NCT01513096|"~     In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were~     proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included~     in a few studies. The investigators study was to show that sufficient dosage of prokinetics~     added to split dose of PEG improves the state of bowel preparation.~   "
117832|NCT01513655|"~     Background: In chronic obstructive pulmonary disease, the prognosis for patients who have~     survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor.~     Despite being shown to improve survival and quality-of-life in stable patients with chronic~     hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in~     unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory~     failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic~     respiratory failure, treated with noninvasive ventilation, we have been able to reduce~     mortality and the number of repeat respiratory failure and readmissions by continuing the~     acute noninvasive ventilatory therapy as a long-term therapy.~      Methods: Multi-center open label randomized controlled trial of 150 patients having survived~     an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure~     due chronic obstructive pulmonary disease. The included patients are randomized to usual~     care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a~     one-year follow-up period.~      End points: The primary endpoint is one-year mortality; secondary endpoints are time to~     death or repeat acute hypercapnic respiratory failure, number of readmissions and repeat~     acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep~     quality, lung function, and arterial gases.~   "
117833|NCT01513642|"~     Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac~     surgery patients, the breath-stacking technique has been proposed as an alternative to~     increase pulmonary volumes in the post-operative period.~      Objective: To compare inspiratory volume and electromyographic activity of respiratory~     muscles during breath stacking technique and incentive spirometry in patients undergoing~     cardiac surgery.~   "
117834|NCT01513629|"~     Autism spectrum disorders (ASD) is a highly hereditary neuropsychiatric disorder. In~     children and adolescents worldwide, the prevalence of ASD is estimated at 0.6%.~     Understanding the biological mechanism of this disorder could potentially facilitate prompt,~     accurate and personalized therapy. The dysfunction of fronto-temporal circuitry may explain~     language impairment in ASD. In addition, pieces of evidence suggest that the abnormality of~     the cortico-striato-thalamic circuitry might be related to social deficits. However, very~     little is known how changes in these two circuitries are related to variation in genotypes.~     Previous reports on ASD using magnetic resonance imaging (MRI) have demonstrated alteration~     of brain structure. Recent advance in neuroimaging has shown that structural connectivity of~     a specific circuitry is superior to regional analysis in terms of higher penetrance of~     genetic effects and better account for behavioral variance. Therefore, it is plausible that~     connectivity imaging may serve as effective endophenotypes that link clinical manifestation~     (phenotypes) and the biological variables (genotypes). In the past five years, our lab has~     established world leading diffusion spectrum imaging techniques, and applied the techniques~     to clinical studies on ASD, schizophrenia, stroke and epilepsy. The clinical experience and~     technical strengths provide a strong basis for us to extend to imaging genetics, aiming to~     determine effective endophenotypes of ASD. Therefore, the goal of this project is to~     validate structural connectivity of fronto-temporal and cortico-striato-thalamic circuitries~     as effective imaging endophenotypes of ASD. Specifically, the investigators will achieve the~     goal through a series of validation. First, the investigators will demonstrate that~     structural connectivities in the two targeted circuitries are indeed different among groups~     of patients with ASD, unaffected siblings, and neurotypicals. Second, the investigators will~     demonstrate in neurotypicals and unaffected siblings that the altered structural~     connectivities related to social and language impairments are indeed different in carriers~     of risk genes, i.e. CNTNAP2 and SLC25A12, respectively. Last, the investigators will~     demonstrate in all participants that the altered structural connectivities are associated~     with the corresponding behavioral variances in social and language function. This two-year~     project is a cohort study consisting of three groups, namely patient, unaffected siblings,~     and control groups matched in age, gender and handedness. The patient and sibling groups~     consist of 20 boys each, age 10-15 years old, and the control group consists of 40 boys. The~     examination includes behavior assessment (IQ test, neuropsychological and clinical~     assessment), MRI study (structure MRI and diffusion spectrum imaging for structural~     connectivity) and genome scan(specifically candidate genes related to language function,~     i.e. SLC25A12, and to social function, i.e. CNTNAP2). In conclusion, this is the first~     cohort project on imaging genetics in Taiwan. The success of this project will facilitate~     the progress of translational neuroscience in Taiwan. The methodology of validating~     endophenotype will be readily extended to other psychiatric diseases.~   "
117835|NCT01513616|"~     Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of~     chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor~     quality of life. Recent international guidelines have stressed the importance of dyspnea~     alleviation and improvement exercise tolerance as a means of enhancing quality of life and~     other long term outcomes in this population. Modern pharmacotherapy is the first step in~     symptom management but the overall impact of bronchodilator therapy is relatively small.~     Exercise training remains the most effective treatment for ameliorating dyspnea and~     improving exercise endurance and was the main focus of this study.~      The main objectives of the study were:~        1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise~          before and after exercise training (EXT) compared with an untrained control group. By~          multiple regression analysis, the investigators will establish the main contributors to~          dyspnea relief after EXT.~        2. To compare the magnitude of change in endurance during constant work rate cycle~          exercise with those measured during walk tests and the endurance shuttle walk test~          after EXT relative to control. To evaluate which test (constant work rate cycle,~          six-minute walk test, or endurance shuttle walk test) is the most sensitive test for~          measuring changes in endurance after EXT versus control.~        3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load~          cycling with a variety of other activity-related dyspnea questionnaires. To evaluate~          which of these measurements is the most sensitive for examining changes in perceived~          discomfort during exercise.~        4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory~          panic, self-efficacy) to the perceived improvement of symptoms following EXT. The~          investigators will use multiple regression analysis to examine associations between~          changes in perceived dyspnea and changes in anxiety and self-efficacy measured by~          validated questionnaires and Borg intensity ratings?~   "
117836|NCT01513603|"~     CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the~     agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will~     determine the efficacy of the regimen in patients with relapsed ALL.~   "
117837|NCT01513590|"~     This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the~     efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart~     30) in insulin naïve subjects with type 2 diabetes.~   "
117838|NCT01513577|"~     Convalescence after lumbar surgery is dependent on the extensiveness of the surgical~     procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve~     excellent clinical results with less pain, morbidity and disability.~   "
117839|NCT01513564|"~     Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery~     accelerated stay programs with optimized pain management enhance recovery.~      The objective is to evaluate the effect of a revised and optimized perioperative fast track~     program in lumbar fusion surgery.~   "
117840|NCT01513551|"~     The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia~     disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal~     Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar~     13) when administered to healthy adults 50 years of age or older.~   "
117841|NCT01513538|"~     The technological progress allowed the development of more and more sophisticated~     pacemakers, widening the therapeutic indications but also meeting the physiological needs of~     the patient. This progress led to a more and more complex programming for the physicians. To~     help them set optimally the pacing parameters, physicians refer to the existing~     recommendations of learned societies as well as to his expertise. Manufacturers developed~     also algorithms integrated into pacemakers with the aim of assisting physicians in their~     programming.~      TherapyGuide is a function which proposes a programming adapted to the psychopathological~     state of the patient, with a justification based on experts' consensus, clinical studies as~     well as on published articles.~      Physicians have the choice to accept or reject the programming proposed by TherapyGuide.~     When rejected, there is no means to analyze the modifications brought to the proposed set of~     parameters. The nature, the frequency and the reasons of these modifications are not thus~     known.~      The purpose of this study is to assess the acceptance of the TherapyGuide proposals by~     physicians and to identify the most frequent type of programming changes they make and their~     rationale.~   "
117842|NCT01513525|"~     This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic~     profile of liraglutide between administrations in the thigh versus the abdomen and between~     administrations in the upper arm versus the abdomen.~   "
117843|NCT01513499|"~     Exciting advances have led to the concept that hormones can modulate appetite and food~     intake. Oxytocin is a peptide hormone that is released in regions throughout the brain,~     including areas involved in food motivation. Animal studies suggest that oxytocin may reduce~     food intake. The effects of oxytocin administration on eating behavior in humans, which~     could have important implications in eating-related disorders ranging from obesity to~     anorexia nervosa, have not been investigated. This double-blind placebo-controlled~     cross-over study of single-dose oxytocin administration investigates whether:~        1. Caloric intake will decrease following administration of oxytocin versus placebo~        2. Appetite will decrease following administration of oxytocin versus placebo~        3. Resting energy expenditure will increase following administration of oxytocin versus~          placebo~   "
117847|NCT01513447|"~     For most women, the most significant pain they will experience is the pain associated with~     childbirth. Up to one-third of women experience back labor, this typically occurs when the~     fetus assumes varying degrees of malposition, especially the occiput posterior position, and~     causes additional constant pressure against the maternal spine and pelvis. Back labor~     presents as constant pain, that occurs even between contractions. It is often difficult to~     manage, by the patient, the obstetrician, and the anesthesiologist, and may increase the~     rate of instrumental and caesarian delivery.~      Epidural anesthesia/analgesia is the most common and effective intervention used to help~     women cope with labor pain. Dilute concentrations of local anesthetic and opioid provide~     complete analgesia for most women. Some women, however, have breakthrough pain, often due to~     back labor, and require more concentrated drug solutions. This increases the side effects~     associated with these drugs (e.g., hypotension, pruritus, motor block), thus treatment of~     this pain poses a challenge for the anesthesiologist and the obstetrician.~      Sterile water injections (SWI) are a simple and well-established method of managing labor~     pain among midwives. This intervention was first used to alleviate pain associated with~     kidney stones, and was introduced to obstetrics in the 1970s. Using a syringe, small amounts~     of sterile water is deposited subcutaneously near the sacral area. The sterile water causes~     osmotic and mechanical irritation resulting in a brief (15-30 second) and significant~     stinging sensation. The onset of pain relief follows almost immediately and may last for up~     to two hours. The procedure can be repeated a number of times.~      Sterile water for pain management is most often administered using four intracutaneous~     injections: two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm~     medial to the original two injection sites. 0.1 mL of sterile water is injected between the~     dermal layers to raise a small bleb on the skin surface at each of the four sites. In labor,~     the injections are administered sequentially during a uterine contraction, with the series~     of four injections, performed two at a time, completed within 20-30 seconds.~      The investigators hypothesize that the use of sterile water injections in women with~     neuraxial analgesia with breakthrough pain will result in decreased local anesthetic~     requirements and increase patient satisfaction.~   "
117848|NCT01513434|"~     The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has~     been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these~     methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study~     is not easily available nor an in vivo test. The purpose of this study is to compare the~     position of the femoral tunnel aperture on conventional MRI and the outcomes after single~     bundle ACL reconstruction using free tendon Achilles allograft between transportal technique~     and transtibial technique in active young men.~   "
117849|NCT01513421|"~     The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to~     surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill~     patients, this procedure allows to avoid or postpone surgery. In these settings, the~     percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no~     prospective trials has assessed the efficiency of these two modalities of drainage in cases~     of infected intra-abdominal collections. The investigators aimed then to prospectively~     analyzed the efficiency (in term of infectious control) of drainage under active vacuum~     pressure vs. free drainage for the treatment of infected intra-abdominal collections.~   "
117850|NCT01513408|"~     Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer,~     and makes it possible to evaluate tumour response. Achieving pathological complete response~     (pCR) after chemotherapy is the most important prognostic factor for these patients.~     However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients~     who do not achieve pCR is poorly documented, and no specific prognostic factors have been~     clearly identified.Preclinical and clinical studies argue for an immunogenic role of some~     chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating~     recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence~     antitumour immune response, partially contributing to efficacy. Conversely, tumours can~     promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour~     immune response, and increased numbers of regulatory T-cells are associated with less~     favourable prognosis in breast cancer patients. We have previously shown that a high number~     of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry~     on surgical specimens, is associated with better response and better survival in breast~     cancer patients, independently of whether pCR was achieved, the type of chemotherapy used,~     and the type of breast cancer. Therefore, we propose to validate in a prospective study this~     immunological prognostic marker in a large cohort of patients treated with neoadjuvant~     chemotherapy.~   "
117851|NCT01513395|"~     Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound~     examinations and can impede accurate cervical length measurement and placental location~     determination. The timing of bladder voiding is associated with the prevalence of focal~     myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded~     randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for~     cervical assessment compared with no bladder voiding immediately before vaginal ultrasound~     in order to determine the prevalence of focal myometrial contractions during vaginal~     ultrasound cervical assessment and test whether timing of bladder voiding is associated with~     their incidence.~   "
117852|NCT01513382|"~     Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.~   "
117853|NCT01513369|"~     The purpose of this study is to investigate the correlation between HbA1c and iron status in~     Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.~   "
117854|NCT01513356|"~     BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K)~     inhibitor, currently under investigation in a first-in-man study in patients with advanced~     solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic~     activity has been demonstrated and clear signs of anti-tumor activity have been seen with~     BKM120.~   "
117855|NCT01513343|"~     The goal of this study is to develop and test the efficacy of a scientifically-based,~     culturally competent seven-session parent directed, obesity prevention program focused on~     parental feeding strategies that support young children's self-regulation of intake.~   "
117856|NCT01513330|"~     The purpose of the study is to evaluate leakage of a newly developed ostomy product compared~     to standard care in subjects with colostomies. Subjects will be asked to use each test~     product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show~     that the newly developed ostomy product is significantly better to reduce leakage compared~     to standard care.~   "
117857|NCT01513317|"~     The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a~     reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic~     Syndrome (MDS).~   "
117858|NCT01513304|"~     Efficacy of chiropractic manual therapy in infants with excessive crying behaviour.~     Influence of parental bias in reporting crying behaviour.~   "
117859|NCT01513291|"~     The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo~     for preventing migraines in participants with episodic migraine. After a 28-day Screening~     period during which baseline number of monthly migraine days was assessed, participants were~     randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who~     completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2~     weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at~     the initial randomization. In the Run-out Period, participants who received placebo in the~     Treatment Period continued to receive placebo and participants who received MK-6096 in the~     Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested~     in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as~     measured by the mean change from baseline in monthly migraine days averaged over the 12-~     week treatment period.~   "
117860|NCT01513278|"~     The standard treatment for early-stage breast cancer is breast-conserving surgery followed~     by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence~     rates with a good cosmesis and provides an effective alternative to mastectomy. However, in~     most women receiving radiotherapy radiation dermatitis occur to some degree.~      Radiation dermatitis generally manifests within a few weeks after the start of radiation~     therapy. Its onset varies depending on the radiation dose intensity and the normal tissue~     sensitivity of individuals. As the cumulative dose of radiation increases the transient~     erythema occurring during the first weeks of radiotherapy may evolve into the more~     persistent erythema and to dry or even moist desquamation that reflects the damage to the~     basal cell layer and the sweat and sebaceous glands.~      There is currently no evidence that prophylactic treatments, beyond keeping the irradiated~     area clean and dry, are effective in reducing the incidence or severity of radiation~     dermatitis (Bolderston et al. 2006).~      However, together with other enzymes of the peroxidase pathway, SOD scavenges the~     superoxide, hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al.~     1983). In physiological conditions, the production of free radicals (Monte & Sacerdote 1994)~     and the action of antiradicals' enzymes is balanced. Following tissue injuries, either~     pathological or caused by agents such as radiation therapy, an excess production of free~     radicals is observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is~     increased in breast cancer patients before radiation therapy as compared to controls (Seth~     et al. 2003), and decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD~     applied during radiotherapy could be used to prevent the effects of free radicals and thus~     might protect the patient's skin from radiation-induced skin reactions.~      TREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated~     region is divided vertically into two symmetric areas (left and right). One area is treated~     with APN201, the other area is treated with placebo in a double-blind fashion.~      Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy~     and continues until the end of radiation therapy to the whole breast (25 or 28 daily~     fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments,~     section 5.1).~      Study treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both~     treated areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1~     grade is seen between the two treated areas. From that point in time the patient only~     receives the treatment that appeared to be beneficial and this treatment is applied to the~     whole irradiated region until completion of the 25th, respectively 28th, fraction.~      Treatment stops earlier in case of progressive disease or unacceptable toxicity or~     intolerability.~   "
117861|NCT01513265|"~     The aim of this study is to determine whether a clinical pharmacist using the RASP list~     (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients;~     STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can~     optimise the drug use in elderly inpatients.~   "
117862|NCT01513252|"~     The MAPT PLUS study is a two-year extension of follow-up of the patients included in the~     MAPT preventive study, after completion of the interventions. Subjects in the four groups of~     the MAPT study will be prospectively followed. MAPT is a multicentre, randomised,~     placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone,~     multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a~     placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and~     includes an annual follow-up for two years.~   "
117863|NCT01513239|"~     MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A~     (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with~     MK-6072 or MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease~     Clostridium Difficile Infection (CDI) recurrence compared with placebo; and 2) MK-6072 and~     MK-3415A will be generally well tolerated in participants receiving SOC therapy for CDI~     compared with placebo.~   "
117864|NCT01513226|"~     This study shows that cycled light during neonatal care reduces infant's fussing and crying~     behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.~   "
117865|NCT01513213|"~     The purpose of this study is to evaluate whether a correlation exists between the partial~     pressure of carbon dioxide existing within arterial blood and the gradient between inhaled~     and exhaled fractions of oxygen.~   "
117866|NCT01513200|"~     This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12~     healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered~     together have any significant impact on the pharmacodynamic effects of UFH and the~     pharmacokinetics of Bendavia.~   "
117867|NCT01513187|"~     Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in~     the first stage it will determine the optimal dose of the combination of pazopanib and~     interferon alfa-A2 in the treatment of patients with advanced renal carcinoma and a second~     stage that will determine the efficacy of this combination measured in terms of response~     rate.~   "
117868|NCT01513174|"~     This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281)~     versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation~     positive advanced non-small-cell lung cancer.~   "
117869|NCT01513161|"~     The purpose of this study is to determine whether nalfurafine hydrochloride is effective and~     safe in the treatment for conventional-treatment-resistant pruritus in patients receiving~     hemodialysis.~   "
117870|NCT01513148|"~     The introduction of light emitting diode (LED) devices as a novel treatment for pain relief~     in place of low-level laser warrants fundamental research on the effect of LED devices on~     one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A~     randomized controlled study will be conducted by measuring nerve conduction on the~     superficial radial nerve of healthy subjects (n=64). One baseline measurement and five~     post-irradiation recordings (2-min interval each) will be performed of the nerve conduction~     velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32)~     will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris~     Model 705), while the placebo group will be treated by sham irradiation. The purpose of this~     study is to investigate the effects of LED light on the conduction velocity and amplitude of~     the superficial radial nerve.~   "
117871|NCT01513135|"~     Tat is a key HIV regulatory protein produced very early after infection, prior to virus~     integration, and necessary for viral gene expression, cell-to-cell virus transmission and~     disease progression. Previous studies in natural HIV infection, indicated that the presence~     of a Tat-specific immune response correlates with a lower incidence and reduced risk of~     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune~     response to Tat may exert a protective role and control the progression to AIDS in vivo.~     Moreover, Tat is conserved in its immunogenic regions (both B and T cell) among all~     subtypes. subtypes. Recent data, in fact, indicate an effective cross-clade recognition of~     clade B strain-derived (BH-10) Tat protein from the HTLV-IIIB lab-adapted virus strain~     (Buttò, 2003), which was isolated about 30 years ago (Ratner, 1985), by sera from~     individuals infected with viruses circulating at the present in Italy and in Africa, thus~     reflecting the high degree of conservation of the corresponding Tat regions and providing~     strong formal evidence that a Tat-based vaccine may indeed be used in the different~     geographic areas of the world, since it is capable of inducing a broad immune response~     against different virus clades. Based on this rationale and on the positive results of~     preclinical (Cafaro, Nat Med 1999) and phase I preventive and therapeutic clinical trials~     with Tat protein (ISS P-001 and ISS T-001, respectively) (Ensoli AIDS 2008, Vaccine 2009;~     Longo Vaccine 2009; Bellino RRCT, 2009) a phase II therapeutic, open label, clinical study~     with Tat protein (ISS T-002, ClinicalTrials.gov NCT00751595) was sponsored by ISS and~     activated in 11 clinical sites in Italy in HIV-infected HAART-treated subjects (Ensoli F,~     Retrovirology 2015).In this study, subjects are randomized into two arms to receive 3 or 5~     vaccinations monthly; each arm is composed of two treatment groups, receiving 7, 5 or 30 µg~     of Tat, respectively.Results obtained in 168 individuals after trial completion (48 weeks),~     as well as after a follow-up of 144 weeks for a subgroup of vaccines, indicated that Tat~     vaccination is safe, immunogenic and capable of reducing the immune dysregulation which~     persists despite HAART in treated individuals (Ensoli et al,PLoS ONE 2010). Anti-Tat Abs~     were induced in most patients (79%), with the highest frequency and durability in the Tat 30~     µg groups (89%) particularly when given 3 times (92%) (Ensoli B.,PLoS ONE 2010; Ensoli F.,~     Retrovirology 2015). Moreover, vaccination promoted a durable and significant restoration of~     T, B, natural killer (NK) cells, and CD4+ and CD8+ central memory subsets. Moreover, a~     significant reduction of blood proviral DNA was seen after week 72, particularly under~     PI-based regimens and with Tat 30 µg given 3 times (30 μg, 3x), reaching a predicted 70%~     decay after 3 years from vaccination with a half-life of 88 weeks. This decay was~     significantly associated with anti-Tat IgM and IgG Abs and neutralization of Tat-mediated~     entry of oligomeric Env in dendritic cells, which predicted HIV-1 DNA decay. Finally, the 30~     μg, 3x group was the only one showing significant increases of NK cells and~     CD38+HLA-DR+/CD8+ T cells, a phenotype associated with increased killing activity in elite~     controllers (Ensoli F., Retrovirology 2015). These data indicate that Tat immunization~     represents a promising pathogenesis-driven intervention to intensify HAART efficacy (Ensoli~     et al,PLoS ONE 2010).~   "
117872|NCT01513122|"~     The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside~     reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and~     in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis~     are also common in HIV-infected patients. There appears to be some association between ART~     and bone loss, but this is poorly understood and requires further research. The SECOND-LINE~     study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in~     greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently~     standard of care. This study also provides an opportunity to examine if additional bone loss~     occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART~     used in second line therapy result in more or less bone loss than use of other classes of~     anti-HIV drugs such as protease inhibitors or N(t)RTI combinations.~      It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater~     increases in limb fat and smaller reductions in bone density at the proximal femur over 48~     weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).~   "
117873|NCT01513109|"~     The purpose of this study is to evaluate the safety and the efficacy of combined treatment~     strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in~     vivo regulatory T cells depletion as post-consolidation therapy in patients with~     WT1-positive Acute Myeloid Leukemia. The study will also evaluate the clinical activity and~     immune response of this approach in bad risk patients in CR1 and all patients in CR2 or CR3,~     non eligible for an allogeneic Hematopoietic Stem Cell Transplantation~   "
117897|NCT01512797|"~     The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe~     and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.~   "
117875|NCT01513083|"~     This open-label, parallel group study will evaluate the pharmacokinetics and safety of~     trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or~     reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1~     of each 3-week cycle. Anticipated time on study treatment is until disease progression or~     unacceptable toxicity occurs.~   "
117876|NCT01513070|"~     This study investigates the effective power of angina pectoris after Quick-Acting Heart~     Reliever and isosorbide dinitrate interventing respectively the patients with moderate~     coronary stenosis for six months. At the same time, the studying will assess the plaque,~     myocardial blood-supplying,quality of life and observe the end point of the heart (including~     the myocardial revascularization, death and myocardial infarction). The purpose is to study~     the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever~     for moderate coronary stenosis lesions.~   "
117877|NCT01513057|"~     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,~     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's~     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories~     in healthy, adult, human, male subjects under fed conditions.~   "
117878|NCT01513044|"~     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,~     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's~     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories~     in healthy, adult,human, male subjects under fasting conditions.~   "
117879|NCT01513031|"~     The purpose of this study is to determine if follow-up by a pharmacist over the telephone~     improves adherence and short term clinical outcomes in the patient with atrial fibrillation~     prescribed an oral anti-arrhythmic medication. This study will also identify the reasons~     people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication~     counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a~     monthly basis to assess adherence over one year.~   "
117880|NCT01513018|"~     The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High~     tidal volumes may increase the incidence of postoperative lung injury after thoracic~     surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg)~     tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.~      One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were~     randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero~     end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg~     with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute.~     During the subsequent 30 minutes, each patient received the alternative management. Minute~     volume was thus kept constant during each experimental condition. Arterial blood partial~     pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are~     presented as means ± SDs; P < 0.05 was considered statistically significant.~   "
117881|NCT01513005|"~     The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve~     Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be~     proposed as a Day-Case surgery.~   "
117882|NCT01512992|"~     The purpose of this study is to assess the effects of a complex telemedicine intervention as~     a part of an integrated care program for patients with chronic obstructive pulmonary disease~     (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether~     the intervention produces benefits in terms of mortality, reduction in hospital readmissions~     and health-related quality of life. In addition, the trial evaluates the economical and~     organizational impact of the new service and examines its acceptability by patients and~     health professionals.~   "
117883|NCT01512979|"~     The purpose of this trial is to determine whether a initial combination of linagliptin and~     metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed,~     treatment-naïve patients with Type 2 Diabetes.~   "
117884|NCT01512966|"~     This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF~     Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.~   "
117885|NCT01512953|"~     This study aims to prospectively assess whether there is an interaction between genetic~     status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake~     in patients who underwent coronary stenting for elective, urgent or emergent intervention.~   "
117886|NCT01512940|"~     Various gastric restrictive procedures have evolved over the years but abandoned due to poor~     long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic~     gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done~     as an alternative to the other restrictive procedures. But the short and long term safety~     and efficacy outcomes of LGCP is not well documented in current literature. American society~     of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be~     considered investigational at this time and should be performed under a study protocol with~     third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to~     review adverse events and outcomes.~      The objective of this study will be to demonstrate feasibility , short term and long term~     safety and efficacy of LGCP . This will be done by achieving gastric restriction by~     infolding of stomach and thereby achieving good weight loss .~   "
117898|NCT01512784|"~     Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV~     infection and the development of HPV-associated lesions in female and male anogenital tract.~     Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in~     HIV-infected population are few. The present study is a non-randomized controlled clinical~     trial with the primary objective to determine safety ad immunogenicity of quadrivalent human~     papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young~     adults.~   "
117899|NCT01512771|"~     We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal~     CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use~     alcohol to control their symptoms).~   "
117900|NCT01512758|"~     This is an open-label, multicenter, phase 1 study of alisertib in East Asian patients (eg,~     patients from countries including but not limited to Singapore, Hong Kong, Taiwan, and South~     Korea) with either relapsed or refractory advanced solid tumors or lymphomas for which no~     effective standard treatment is available.~   "
117887|NCT01512927|"~     The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan are both the~     highest worldwide from 2001 to 2008. In Taiwan, more than 90% of the ESRD patients are~     hemodialysis patients. Either arteriovenous fistula (AVF) or arteriovenous graft (AV graft)~     is essential for the vascular access of these patients. However, frequent AVF stenosis or~     thrombosis occurs in 10-30% hemodialytic patients, and the rates are even higher, around~     30-70%, in those who has a past history of AVF/AV graft stenosis. Therefore, early detection~     of AVF stenosis is essential in caring for these hemodialysis patients in terms of medical~     economics and psychological impact. Unfortunately, angiographic study is expensive and~     invasive and needs contrast medium injection. The diagnostic accuracy of color duplex~     ultrasound in AVF stenosis remains satisfactory, but it is not always available when~     decreased AVF flow or an acute thrombotic event occurs. Continuous AVF/ AV graft flow~     monitoring by patient himself is a better option in terms of long-term care. Previous study~     indicated that stethoscope waveform analysis could be used as an alternative to diagnosis of~     vascular stenosis. Therefore, we aim to investigate AVF/ AV graft stenosis by using the~     electronic stethoscope (3M Littmann) for AVF sound recording, followed by software analysis~     by using waveform decomposition, principle component analysis (PCA) and sequential forward~     selection algorithm [xx]. Our study results will provide a new diagnostic option, which is~     low cost, non-invasive and self-monitoring, of AVF stenosis in ESRD patients.~   "
117888|NCT01512914|"~     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after~     laparoscopic procedures have provided conflicting results. This randomized, double-blind~     study was designed to assess the effects of a novel intraperitoneal local anesthetic~     administration technique using nebulization on pain relief after gynecologic laparoscopic~     surgery.~   "
117889|NCT01512901|"~     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for~     macular edema following branch retinal vein occlusion~   "
117890|NCT01512888|"~     SCID-X1 is a genetic disorder of blood cells caused by DNA changes in a gene that is~     required for the normal development of the human immune system. The purpose of this study is~     to determine if a new method, called lentiviral gene transfer, can be used to treat SCID-X1.~     This method involves transferring a normal copy of the common gamma chain gene into the~     participant's bone marrow stem cells. The investigators want to determine if the procedure~     is safe, whether it can be done according to the methods they have developed, and whether~     the procedure will provide a normal immune system for the patient. It is hoped that this~     type of gene transfer may offer a new way to treat children with SCID-X1 that do not have a~     brother or sister who can be used as a donor for stem cell transplantation.~   "
117891|NCT01512875|"~     The objective of this study is to elucidate the role of drinking water derived from the~     public source in Lima, Peru and transmission of H. pylori infection using genotypic~     techniques.~   "
117892|NCT01512862|"~     Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a~     marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency~     is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and~     lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect~     in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of~     vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary~     hyperparathyroidism in patients with advanced chronic kidney diseases.~      Therefore, the objective of this study is to evaluate the anti-proteinuric effect of~     calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and~     placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function,~     serum and urinary inflammatory markers, and adverse event will be monitored.~   "
117893|NCT01512849|"~     The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with~     type 2 diabetes mellitus who have moderate renal impairment.~   "
117894|NCT01512836|"~     This randomized controlled trial (RCT) will examine a nurse case management model for~     patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish~     municipality, and is performed in order to evaluate the use of case management as a tool in~     achieving integrated, quality and cost-effective care for this group of patients.~      The main objectives are to evaluate how case management influences on hospital admissions,~     mortality, quality of life and self care, as well as to compare costs and cost-effectiveness~     of case management vs. usual care.~   "
117895|NCT01512823|"~     This pragmatic randomised controlled trial (RCT) used a two-group parallel design with~     matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed~     to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge,~     skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with~     occupational therapists in a public health setting. Occupational therapists employed by the~     Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight~     consented to participate and were randomly allocated to either an interactive (IE) or a~     didactic (DE) educational intervention using coin tossing. Data was collected at baseline~     and 12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an~     improved total knowledge score. Secondary outcomes were improved attitudes and behaviour.~     Data were collected at the health facilities where participants were employed. Raters for~     the audit were blinded but participants and the provider could not be blinded.~      Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants~     in the IE and 21 in the DE completed the trial and were included in the 12 week analysis.~     Results revealed no significant difference between the groups in the primary knowledge~     outcome at 12 weeks. Examination of within-group changes revealed significant improvements~     in knowledge in both groups (IE: T=4.0, p<0.001; DE: T=12.0, p=0.002), but the IE also~     showed a significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale~     (T=33.0, p=0.039). As the study was powered at 43%, it may have failed to detect significant~     differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was~     assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic~     and interactive educational interventions can improve knowledge, but it seems that~     interactive interventions may be more effective for changing behaviour. High-quality~     pragmatic trials can feasibly be conducted within the public health service~   "
117896|NCT01512810|"~     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical~     staging for endometrial cancer increases operative time and surgical morbidity, but appears~     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic~     approach has not been reproduced, and the investigators propose to validate their algorithm~     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary~     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the~     investigators are well-suited to perform this investigation. A surgical approach that is~     tailored to the patient's cancer biology is rational, supported by the recent literature,~     and medically compelling since the co-morbidities of many obese, low-risk EC patients put~     them at significantly increased perioperative risk for complete lymphadenectomy.~   "
117901|NCT01512745|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.~     The investigators' phase I study has shown that the drug's toxicity is manageable and the~     maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether~     apatinib can improve progression free survival or overall survival compared with placebo in~     patients with metastatic gastric carcinoma who failed two lines of chemotherapy.~   "
117902|NCT01512732|"~     Today, no non-verbal auditory stimuli that assess mental processing are available in Israel.~     The goal of this study is to make available a validated set of auditory stimuli in Israel.~     We created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is~     a novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts~     corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by~     ten different actors. The uniqueness of these affective bursts is that they do not contain~     verbal context, but rather express affective moods using the vowel /a/ (as in apple). In~     this study, the investigators will verify the new Hebrew version of MAV in healthy control~     groups. Next, the investigators will compare the mental processing ability in young vs. old~     population, using the MAV test. In addition, the investigators will assess mental processing~     in two pathologic study groups (Parkinson's disease, major depressive disorder) using the~     MAV test. The investigators intend to use the MAV tool in future research in Parkinson's~     disease and depression.~   "
117903|NCT01512719|"~     POEM has recently described as an alternative treatment for achalasia in humans. In this~     procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus.~     In this study we aim to perform POEM on achalasia patients.~   "
117904|NCT01512706|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final~     results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit~     vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by~     SFDA in China, Dec. 2010. The phase I clinical trial was completed, during four months, in~     Guangxi Province, China. The phase II clinical trial has been carried out, from July 2011.~     The purpose of phase II is to evaluate the safety and efficacy of the formalin-inactivated~     EV71 vaccine in Chinese infants (from 6 to 36 months old).~   "
117905|NCT01512693|"~     This open-label, non-randomized study was designed to compare pharmacokinetics of a single~     50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic~     insufficiency (abnormal liver function) in order to determine to what degree hepatic~     dysfunction may impact therapeutic blood levels of MK-0822.~   "
117906|NCT01512680|"~     Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic~     patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The~     hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and~     better quality of life. 60 patient will be enrolled and followed during one year.~   "
117907|NCT01512667|"~     This study will investigate and compare pharmacokinetics of a single 50 mg dose of~     odanacatib administered to participants with impaired renal/kidney function to those of a~     healthy matched control group.~   "
117908|NCT01512654|"~     The primary purpose of this study is to see whether a tool that predict blood glucose and~     suggest therapy advices can help type 1 diabetic patients.~   "
117909|NCT01512641|"~     Schizophrenia beginning before 18 years is a clinical entity not well known because of its~     low incidence and difficulties in the clinical diagnosis.~      However, in the investigators clinical practice, due to the specialization of the~     investigators service, the investigators are led to hospital to receive important feel~     active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text~     revision (DSM IV-TR) precose schizophrenia.~      The work of us team on the theme of the relationship between Pervasive Developmental~     Disorders and precose Schizophrenia led us to hypothesize that a number of children in care~     in the medical and educational institutes, hospitals and day shelters therapeutic part-time~     symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not~     diagnosed.~      The main goal is to estimate the prevalence of dissociative disorders in a population of~     children in care institutions and medical education in child psychiatry in hospitals and~     others structures.~   "
117910|NCT01512628|"~     The investigators administered different kinds of colloids before transfusion of red blood~     cell to patient undergoing total hip replacement arthroplasty. The investigators will~     compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.~   "
117911|NCT01512615|"~     The aim of the study is to describe the effect and meaning of an integrated rehabilitation~     programme, consisting of physical training and psycho-educational care, for patients treated~     for infective endocarditis.~      The hypothesis is, that integrated rehabilitation can improve mental health, physical~     capacity and other factors.~   "
117929|NCT01512381|"~     The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is~     superior to interventricular right ventricle (RV) septal pacing in respect of reverse~     remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection~     fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received~     atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)~   "
117930|NCT01512368|"~     We evaluated the effect of two weeks of intensive supervised physical activity in serum~     fibroblast growth factor 21 (FGF21) levels.~   "
118013|NCT01511289|"~     In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg~     twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients~     with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic~     phase (CML-CP).~   "
117912|NCT01512602|"~     Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior~     Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed~     supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with~     self behavior and personality traits within the spectrum of borderline personality disorder.~      Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT)~     after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on~     self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and~     consumption of hospital services in patients with symptoms within the spectrum of borderline~     personality disorder (BDP).~      Method: The investigators will include 160 patients in the randomized trial to investigate~     whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive~     psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm~     behavior and personality traits within the spectrum of borderline personality disorder. The~     trial will meet strict criteria for high quality randomized trials, and will hopefully help~     to establish evidence for the treatment of this patient group at higher risk of later~     suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.~   "
117913|NCT01512589|"~     The goal of this clinical research study is to learn how safe and effective proton-beam~     therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in~     combination with chemotherapy in patients with esophageal cancer.~      PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area~     of the body while affecting as little of the surrounding normal tissue as possible. PBT is a~     newer technology that is designed to further reduce the amount of radiation that affects the~     surrounding normal tissue. However, this is still being studied.~   "
117914|NCT01512576|"~     This physiological study examines whether acupuncture exerts short-term effects of analgesic~     mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether~     acupuncture activates brain-orchestrated pain inhibitory action.~   "
117915|NCT01512563|"~     Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common~     Covered Metallic Biliary Stent.~   "
117916|NCT01512550|"~     The purpose of this prospective, randomized study is to evaluate the importance of restoring~     the exact individual hip biomechanics during total hip arthroplasty.~   "
117917|NCT01512537|"~     The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation~     in treatment of vitamin D deficiency.~   "
117918|NCT01512524|"~     The primary objective is to assess the long-term impact of hormonal deficiency on Quality of~     Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.~   "
117919|NCT01512511|"~     There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common~     use, has not compared to N2O sufficiently to disclose which one has minimal physiological~     invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the~     hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal~     CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were~     recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure~     by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and~     compared.~   "
117920|NCT01512498|"~     The study will evaluate the prevalence and characteristics of vulvovaginal graft versus host~     disease (VV- GVHD) in patients who underwent hematopoietic stem cell transplantation (HSCT)~     as girls or adolescents and will compare the prevalence, characteristics and severity of~     VV-GVHD before and after menarche.~   "
117921|NCT01512485|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75~     mg tablet under fed condition.~   "
117922|NCT01512472|"~     Men with localized prostate cancer requiring intermittent androgen deprivation therapy for~     biochemical recurrence following radical therapy will be asked to participate in a phase 4~     safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix~     (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.~   "
117923|NCT01512459|"~     The objective of this study was to compare the relative bioavailability of Venlafaxine MR~     Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human~     subjects.~   "
117924|NCT01512446|"~     The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long~     term treatment of osteoporosis.~   "
117925|NCT01512433|"~     The purpose of this study is to investigate the efficacy of acupuncture therapy combined~     with standard methadone maintenance therapy to the heroin addicts.~   "
117926|NCT01512420|"~     This prospective observational study will evaluate the efficacy and safety of second-line~     Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer~     with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study~     is to identify from baseline clinical and demographic patient characteristics prognostic~     factors related to overall survival with second-line Tarceva treatment. Data will be~     collected from eligible patients for up to 2 years.~   "
117927|NCT01512407|"~     We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection~     in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver~     and thus improve survival. The aim of this study is to compare the survival of patients~     undergoing liver resection plus post-operative TACE versus liver resection alone.~   "
117928|NCT01512394|"~     Current management of elective bowel surgery typically involves performing a preoperative~     bowel preparation (bowel prep) in many instances; however, this practice is not~     standardized at most institutions. Over the years, bowel preps have been used in an attempt~     to decrease the risk of complications associated with gastrointestinal surgery. However,~     there is limited adequate data to support this clinical management in the pediatric patient~     population. The investigator plans to perform a prospective, randomized study of our~     pediatric surgical patients who will undergo an elective bowel resection or ostomy closure~     to assess if a bowel prep prior to surgical intervention affects their postoperative course.~     The aim of this study is to evaluate for differences that may alter and improve future~     management.~   "
117931|NCT01512355|"~     Postoperative agitation in children is a well-documented clinical phenomenon with incidence~     ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the~     pediatric population and there is now increasing evidence to support the use of this drug as~     sedative and anesthetic adjunct in children. The purpose of this study is to determine~     whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.~   "
117932|NCT01512342|"~     Given the lack of evidence in support of pacing self-management for patients with chronic~     fatigue syndrome (CFS), it is examined whether physical behavior and health status of~     patients with CFS improve in response to a pacing self-management program. The effects of~     pacing will be compared with those observed when applying relaxation therapy to patients~     with CFS.~   "
117933|NCT01512329|"~     Given the lack of evidence in support of pacing self-management for patients with musltiple~     sclerosis (MS), it is examined whether physical behavior and health status of patients with~     MS improve in response to a pacing self-management program. The effects of pacing will be~     compared with those observed when applying relaxation therapy to patients with MS.~   "
117934|NCT01512316|"~     The present study investigates the effect of d-cycloserine on learning and unlearning of~     fear in healthy humans and its underlying effect on the amygdala.~      As a second objective, the effect of genotype on fear learning will be studied.~   "
117935|NCT01512303|"~     The overarching aim of this proposal is to research whether meditation-based treatments are~     effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which~     complementary and alternative (CA) treatments are most effective, and how individual~     differences predict treatment efficacy.~   "
117936|NCT01512290|"~     Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the~     majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant~     minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of~     alternative treatment options for this medication resistant group is currently low and most~     of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in~     contrast, is a non-invasive technique of influencing cortical excitability. This technique~     has the potential to actually decrease the frequency and severity of medication resistant~     hallucinations.~      Several previous studies have assessed efficacy of low frequency rTMS, with contradicting~     results. A previous large study by the investigators group could not demonstrate efficacy of~     low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a~     more effective therapeutic option.~      Objective: The present study aims to examine the efficacy of TBS on the severity of AVH.~     Study design: The objectives are tested in a randomized double blind placebo-controlled~     trail.~      Study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder,~     schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal~     hallucinations will be included.~      Intervention: The participant will receive either 10 TBS treatments or 10 placebo treatments~     consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area,~     distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.~      Main study parameters/endpoints: the main study parameter is the change in the severity of~     the AVH. The secondary study parameter is the number and severity of adverse events.~   "
117937|NCT01512277|"~     The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy~     volunteers of the vaccine candidate against schistosomiasis named Bilhvax.~   "
117938|NCT01512264|"~     In this study the investigators will examine the efficacy of (1) navigated excitatory~     repetitive transcranial magnetic stimulation (nerTMS) and (2) a combination of nerTMS and~     constraint induced aphasia therapy (CIAT) as post-stroke aphasia rehabilitation methods. The~     investigators expect that these new types of rehabilitation, either nerTMS alone or in~     combination with CIAT, will help patients with aphasia return to their lives as they were~     prior to the stroke.~   "
117939|NCT01512251|"~     This is a phase 1/2 clinical trial with the goal of determining whether the addition of the~     investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free~     survival in patients with BRAFV600E/K mutant melanoma.~   "
117940|NCT01512238|"~     The purpose is to study if different factors influence medicine adherence in elderly people.~     In this study number of generic substitution and use of non-prescription drugs, herbal~     medicine and dietary supplement is in focus.~   "
117941|NCT01512225|"~     The purpose of this study is to evaluate the safety and efficacy of Domperidone in those~     mothers who are identified as having difficulty with breast milk production to meet the~     nutritional needs of their infant in the neonatal intensive are unit (NICU) hospitalization~     setting, and to determine how it should be considered in the care of mothers and their~     preterm infants without causing undesirable effects to either the mother or infant.~   "
117942|NCT01512212|"~     Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB)~     apparatus of which patented from Turkish Patent Institute.~   "
117943|NCT01512199|"~     This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are~     receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b~     portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in~     subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the~     treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel~     with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine~     if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in~     subjects with metastatic breast cancer.~   "
117944|NCT01512186|"~     The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to~     surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five~     patients will be recruited into his study.~   "
117945|NCT01512173|"~     There is an unsatisfied medical need for a first-line treatment of localized uncomplicated~     proliferating Infantile Hemangioma with a good benefit/risk profile.~      Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A)~     which is a topical gel adapted to paediatric use.~      The objective of this study is to evaluate topical propranolol efficacy and safety in the~     management of localized hemangioma.~   "
117946|NCT01512160|"~     The purpose of this study is to evaluate the overall pain relief of a single dose of~     PF-04531083 against placebo following third molar extraction.~   "
117947|NCT01512147|"~     The investigators want to know if using the study drug dexmedetomidine will improve nerve~     wave readings during neurosurgery. These readings are done many times during surgery while~     the patient is asleep. The readings look at how nerves are working and let the operating~     team know if nerves are hurt during surgery. If the readings tell that nerves are not~     working correctly, the surgeons can help while changing the way of operating.~      The study drug will be used in addition to the general anesthesia that a patient is given.~     The nerve readings that the investigators get while using the study drug will be compared~     with nerve readings that the investigators get while not using the study drug.~      The study hypothesis is that dexmedetomidine does not change nerve readings.~   "
117948|NCT01512134|"~     The purpose of this clinical study is to investigate the safety and efficacy of deep brain~     stimulation (DBS) as a treatment option for obesity.~   "
117949|NCT01512121|"~     The overall objective of this study is to assess patterns of fMRI cortical activation with~     spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define~     cortical correlates, as well as to investigate cortical representations of pain and pain~     relief and the interactions therein, in the setting of neuropathic leg pain and SCS.~   "
117950|NCT01512108|"~     This trial was conducted in Japan. The aim of this trial was to evaluate the safety and~     efficacy of once daily administration of liraglutide in combination with an oral~     anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently~     controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either~     glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at~     unchanged type and dose.~   "
117951|NCT01512095|"~     This trial is conducted in Europe and United States of America (USA). The aim of this trial~     is to examine the bioequivalence (assessment of the expected biological equivalence of two~     pharmaceutical drug products with identical active ingredient) of Norditropin® versus~     Nutropin AQ® in healthy adult volunteers.~   "
117952|NCT01512082|"~     Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal~     muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.~   "
117953|NCT01512069|"~     Life style interventions that promote exercise and a healthy diet, which have the potential~     to improve health-related quality of life (HRQOL), may be particularly appropriate for~     cancer survivors. The previous studies suggested that a key strategy to implement~     sustainable healthy behavior and improve health was providing appropriate feedback and~     promoting self-efficacy. Web-based program enables to provide the feedback in a timely~     manner on a daily basis, to continue the healthy behaviors.~      Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning~     program, and whether the program can promote significantly greater changes in behavioral~     outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and~     diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes~     for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and~     self-efficacy in implementing goal of exercise and diet among breast cancer survivors in~     Korea was examined.~      Hypotheses were following:~        1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet~          Planning program (hereinafter called the 'intervention group') will show a more~          advanced stage of change for exercise and diet compared to survivors in the control~          group.~        2. The intervention group will show a higher proportion of attaining goal of exercise (or~          higher level of energy expenditure of aerobic exercise) compared to the control group.~        3. The intervention group will show a higher proportion of attaining goal of diet (or~          higher level of diet quality) compared to the control group.~        4. The intervention group will show a better HRQOL level compared to the control group.~        5. The intervention group will show a better self-efficacy level compared to the control~          group.~        6. The intervention group will show a lower fatigue level compared to the control group.~        7. The intervention group will show less anxiety compared to the control group.~        8. The intervention group will show less depression compared to the control group.~   "
117954|NCT01512056|"~     The purpose of this study is to evaluate the antibody response in dialysis patents to each~     of the three influenza vaccine strains included in the licensed seasonal flu vaccine~     (Formulation 2011-2012).~   "
117955|NCT01512043|"~     There is a demand for explorative and comparative studies on various non-pharmaceutical~     efforts in treating and helping chronic obstructive pulmonary disease patients. This study~     has been developed in light of this need. The main purpose of the project is to test whether~     a device guided breathing control system can decreasing the feeling of breathlessness in~     patients with moderate stage and severe stage of COPD. In addition the study could shed~     light on whether a reduced feeling of breathlessness can lead to improved physical function,~     and less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties,~     fatigue, pain) and provide a better quality of life for patients with COPD.~   "
117956|NCT01512030|"~     Diabetes mellitus type I is an increasing burden for more and younger children. Therapy~     should avoid long-term complications as macrovascular diseases and diabetic nephropathy,~     retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the~     prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic~     criteria. Nerve conduction velocity studies are regarded as the gold standard for~     investigating neuropathies.~      We plan a prospective study by investigating the peripheral nerve conduction velocity in a~     population of diabetic children. At the same time-points, we will do a neurological~     examination using the Young Score, a clinical score of peripheral neuropathy [10]. The~     results obtained will be related to other long-term vascular complications (nephropathy,~     retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of~     sports/week, and BMI~   "
117957|NCT01512017|"~     This study is a multi-center, randomized, open and paralleled positive control study for~     evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft~     donor sites. The result implies that Veloerm can do it better than Vaseline gauze in~     accelerating and promoting wound healing of skin graft donor sites. The present study have~     indicated that high permeability of Veloderm dressing to oxygen and water vapor.~   "
117958|NCT01512004|"~     The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine~     Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese~     population with urgent micturition, frequent micturition and/or urge urinary incontinence.~   "
117959|NCT01511991|"~     The purpose of this study is to determine sevoflurane's dose-dependent effect on left~     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of~     lateral mitral valve annular velocity at three different sevoflurane concentrations would be~     analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery~     patients.~   "
117960|NCT01511978|"~     Hypothesis: 3,4-DAP improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.~   "
117986|NCT01511640|"~     Cannabis is the most commonly used illicit drug in the United States, and its use is~     associated with rates of development of abuse and dependence, treatment admission and~     relapse that are comparable to other illicit drugs. Currently there is no effective~     pharmacological treatment for cannabis-use disorders. The purpose of the present study is to~     evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its~     effectiveness as a medication for cannabis-use disorders.~   "
117961|NCT01511965|"~     Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of~     melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and~     social, that sounds a lot about the quality of life. Currently the standard treatment for~     vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half~     of patients. The applications of autologous epidermal cells in the liquid phase is a~     promising new therapeutic approach of vitiligo.~      The main goal of this study is to compare prospectively the repigmentation of vitiligo~     lesions induced by application of autologous epidermal cells in liquid phase associated with~     light therapy and light therapy alone.~      Study's secondary goals: compare the applications of epidermal cells to phototherapy alone~     and phototherapy, in respect of:~        -  Obtain a repigmentation> 70% (threshold considered aesthetically relevant)~        -  The occurrence of adverse events~        -  Patient satisfaction regarding the efficacy and safety of treatment~   "
117962|NCT01511952|"~     This is a multi-site study of 272 premature infants >32 weeks who served in a randomized~     investigation (in morning or afternoon) where they served as their own controls. The~     infants' HR, RR, O2sats were measured with and without the implementation fo live music. The~     live interventions included songs of kin, selected by parents, the gato box and ocean disc~     played through entrained methods by a music therapist. The infants were evaluated within a~     two week period and in total each day including feeds, voids, activity level and sleep.~   "
117963|NCT01511939|"~     The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug~     (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who~     are also taking anticoagulant or antithrombotic medications.~   "
117964|NCT01511926|"~     The most common pain-relievers used by patients with rheumatic disorders are called~     non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well~     documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet~     containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with~     rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where~     lower doses of naproxen or other NSAID treatment is not considered sufficient, could use~     this tablet. The regulatory authorities in many European countries have approved the use of~     Vimovo™, but they would like to understand how various factors influence the doctors'~     decision to prescribe the tablet and what is characterizing the patients receiving it. The~     aim of the study is to answer these questions.~   "
117965|NCT01511913|"~     The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the~     treatment of unresectable or metastatic melanoma in the post-approval setting.~   "
117966|NCT01511900|"~     The primary objective of the study is to evaluate the safety of escalating multiple doses~     over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).~      Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of~     escalating multiple doses of CAT-1004 in patients with T2D.~   "
117967|NCT01511887|"~     The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term~     20-28 days old newborn referred to Bandarabbas children' hospital in 2011.~   "
117968|NCT01511874|"~     The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the~     treatment of subjects with prostate cancer.~   "
117969|NCT01511861|"~     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic~     goal that is difficult to achieve with current blood glucose monitoring technology. Home~     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of~     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and~     easy to operate glucose monitoring in DM patients for strict glycemic control cannot be~     overemphasized.~      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an~     acceptable mean relative error when compared to acceptable invasive blood glucose~     measurements.~      The primary objectives of the trial are to determine:~        1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels~          compare to the standard glucose blood test~        2. Creating database of glucose levels readings utilizing the Glucometer GM-205.~   "
117970|NCT01511848|"~     Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of~     combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional~     iron overload~      Primary Outcome Measures:~      • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the~     change in serum ferritin compared to baseline) with combining DFP and deferasirox compared~     to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend~     of SF over previous 12 months on single chelator.~      Secondary Outcome Measures:~      • The secondary outcome measure is to determine the number of patients who will develop~     adverse events in order to assess safety upon administering the drugs in combination (DFP~     and DFX) compared to the combination of DFO and DFP.~   "
117971|NCT01511835|"~     The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational~     diabetes in high risk pregnant women.~   "
117987|NCT01511627|"~     The investigators hypothesize that a spinal anesthetic administered prior to the induction~     of general anesthesia will result in reduced need for pain medication and reduced~     postoperative pain, as well as reduced hospital stay following a total abdominal~     hysterectomy.~   "
117998|NCT01511484|"~     This study investigated whether illustration of the facial appearance benefits of fruit and~     vegetable consumption is able to motivate increased intake of this food group. The~     investigators hypothesize that individuals witnessing illustrations of the impact of a~     healthy diet will exhibit improvements in diet relative to a control group receiving only~     information on the health-benefits of this food group.~   "
118030|NCT01511068|"~     The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant~     human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to~     partial dysfunction of the GM-CSF receptor.~   "
118248|NCT01508156|"~     The purpose of the study is to test the safety and tolerability of different doses of IDX719~     to find the best dose for future studies. The study will also assess the pharmacokinetics of~     IDX719. No formal hypotheses will be tested.~   "
118249|NCT01508143|"~     The aim of this study is to compare two misoprostol regimen in pregnancy termination.~   "
117972|NCT01511822|"~     Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and~     endocrine abnormalities and clinical symptoms.~      The primary defect in PCOS consists of an abnormal androgen synthesis and secretion,~     particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers,~     explaining the frequent association of PCOS with these metabolic conditions.~     Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and~     adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the~     liver. It results in an increase in free, biologically active androgens which are related to~     clinical signs such as hirsutism, acne, seborrhea, and alopecia.~      Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely~     used in this group of patients providing clinical improvement in the areas of excessive hair~     growth, unpredictable menses, acne, and weight gain.~      More recent studies outlined a deficiency in myo-inositol in women with PCOS and~     insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and~     it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle~     trafficking, and chromatin remodeling. It is a precursor in the synthesis of~     phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.~      It has been reported that the administration of myo-inositol reduces serum insulin,~     decreases serum testosterone and enhances ovulation.~      Due to the different beneficial actions, the aim of the present study is to evaluate the~     clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl~     estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin~     resistance.~   "
117973|NCT01511809|"~     The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior~     proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable~     suppressed viremia and no prior virologic failures.~   "
117974|NCT01511796|"~     The purpose of this study is to examine the effects of a combination of Botulinum Toxin~     (BT) and Upper Limb (UL) rehabilitation compared to BT only on UL motor function in~     adults with spasticity after stroke using a pre-post design. The research question is~     whether combination of BT and UL rehabilitation compared to BT only is more effective in~     improving the UL function, range of motion and pain.~   "
117975|NCT01511783|"~     The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to~     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when~     administered to healthy elderly subjects.~   "
117976|NCT01511770|"~     The objective of this study was an open-label, randomized, 2-way crossover to compare the~     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer~     (Diflucan®) 200 mg fluconazole tablets under fasting conditions.~   "
117977|NCT01511757|"~     The objective of this study was an open-label, randomized, 2-way crossover to compare the~     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer~     (Diflucan®) 200 mg fluconazole tablets under fed conditions.~   "
117978|NCT01511744|"~     Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological~     Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to~     the influenza immunity of age 3 and older population. Phase III clinical study was conducted~     in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had~     good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production~     approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.~      In order to monitor and evaluate the safety and protective effect against influenza~     administered on age 3 and older population, therefore we conduct the phase IV clinical trial~     of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).~   "
117979|NCT01511731|"~     The objective of this study was to compare the single-dose relative bioavailability of Reddy~     Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.~   "
117980|NCT01511718|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single~     dose, crossover, oral bioequivalence study.~   "
117981|NCT01511705|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single~     dose, crossover, oral bioequivalence study.~   "
117982|NCT01511692|"~     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the~     effects of liraglutide on energy intake in subjects with type 2 diabetes.~   "
117983|NCT01511679|"~     This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and~     shorter-term effect of adolescent alcohol use on the developing brain.~   "
117984|NCT01511666|"~     Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter~     clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest~     compression device, extracorporeal life support (ECLS) and early invasive investigation and~     treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary~     angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed~     cardiac origin compared to standard of care. It is hypothesized, that above stated~     hyperinvasive approach might improve outcome of out-of hospital cardiac arrest victims.~   "
117985|NCT01511653|"~     The investigators are undertaking a multi-center, 6000 subject validation study of several~     biomarkers for early detection of colon cancer. There are 2 stool based biomarkers (one is a~     panel) and 1 serum based biomarker being validated in this study. The biomarkers will be~     compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the~     current standards for colon cancer screening. This is an NCI-early Detection Research~     Network funded project. The population targeted for this study are those persons undergoing~     colonoscopy for screening or routine surveillance. Prior to colonoscopy or even prepping for~     colonoscopy, subjects will provide blood and stool samples as well as specific data~     regarding their GI and general medical history and concomitant medications. If subjects are~     interested in participating, arrangements will be made to see them. The informed consent~     process will take place, blood will be obtained, data will be obtained, and the stool kit~     described and given to the subject to take home. Stool samples will be sent back to the~     University of Michigan from all sites using prepaid UPS mailing labels.~   "
118011|NCT01511315|"~     This study aims to see if patient quality of life can be approved after treatment with an~     injectable medication called ustekinumab for the treatment of generalized psoriasis. The~     investigators hypothesize that the investigators will see improvement in quality of life.~   "
117988|NCT01511614|"~     Background:~      - Smoking is thought to cause changes in the brain that lead to addiction and craving.~     Smokers who try to quit experience nicotine withdrawal symptoms that include irritability,~     anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop~     smoking. Many people say that they continue smoking to help relieve these symptoms, often~     within the first week after trying to quit. Researchers want to study what is happening in~     the brain to cause these symptoms, which may help identify new ways to successfully quit~     smoking.~      Objectives:~      - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for~     36 hours.~      Eligibility:~      - Individuals between 18 and 55 years of age who smoke at least 10 cigarettes per day.~     Participants must be able to stop smoking for 36 hours on two occasions.~      Design:~        -  This study will involve three visits to the National Institute on Drug Abuse.~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be collected, as well as breath samples to test for recent alcohol use.~          Participants will also fill out questionnaires and learn about the tests at the next~          two visits.~        -  Before each imaging visit, participants will stop smoking for 36 hours. Before one~          visit, participants will wear a nicotine skin patch. Before the other visit,~          participants will wear a placebo (dummy) patch with no nicotine. Participants will not~          be told which type of patch they are wearing. Participants will measure the level of~          carbon monoxide in their breath during both of these nonsmoking periods. They will also~          complete questionnaires about mood and cigarette cravings.~        -  Participants will have two study visits with imaging studies to measure brain activity.~          Each imaging visit will last about 9 to 10 hours. The visit will involve two separate~          1.5- to 2-hour scan sessions (a morning scan and an afternoon scan). These scan~          sessions will involve tests of concentration, memory, and reaction time. Other tests~          and questionnaires will also be completed outside of the scanner before and after the~          sessions.~   "
117989|NCT01511601|"~     Background:~      - Some clinical trials require larger amounts of plasma and white blood cells than can be~     collected through simple blood donations. Apheresis is a procedure used to collect parts of~     the blood for study and return the rest of the blood to the donor. Healthy volunteers who~     provide plasma and white blood cells for study may need to give multiple donations.~     Researchers want to use apheresis to collect plasma and white blood cells from healthy~     volunteers in Mali.~      Objectives:~      - To collect plasma and white blood cells from healthy volunteers in Mali.~      Eligibility:~        -  Healthy volunteers between 18 and 55 years of age.~        -  Volunteers must be in National Institute of Allergy and Infectious Diseases clinical~          trials.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          provide basic blood and urine samples.~        -  Participants will have apheresis to collect plasma and white blood cells for study.~          Before each collection, they will provide a small blood sample for testing. They will~          be monitored during and after donation to prevent side effects.~        -  Under this protocol, participants may have apheresis up to six times per year.~        -  No treatment will be provided as part of this protocol.~   "
117990|NCT01511588|"~     Background:~      - The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels~     through the bloodstream to the pituitary gland, where it stimulates the gland to produce~     hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The~     testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare~     for ovulation. Normal estrogen and testosterone levels are required for puberty. Some~     people, however, have either low levels or total lack of GnRH. This can cause problems with~     puberty and fertility. Researchers want to study people with low or no GnRH to better~     understand how it affects puberty and fertility.~      Objectives:~      - To study disorders of GnRH production.~      Eligibility:~        -  Adult men and women at least 18 years of age with low or no gonadotropin levels.~        -  Adolescents between 14 and 18 years of age with low or no gonadotropin levels.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have tests to look at their hormone levels. Blood samples may be~          collected after taking different drugs, including insulin and cortisone. A 24-hour~          urine sample will be collected.~        -  Participants will have imaging studies to look at bone and brain development. They will~          also have ultrasounds of the kidneys, abdomen, and reproductive organs.~        -  Tests of smell and hearing will be used to look for abnormalities in these senses.~   "
117991|NCT01511575|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn about changes that occur in RNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute~     myeloid leukemia or other transient myeloproliferative disorder.~   "
117992|NCT01511562|"~     The purpose of this study is to find out what effects (good and/or bad) treatment with~     chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary~     CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell~     lymphoma is not known.~   "
117993|NCT01511549|"~     Primary Objective:~      To assess the safety and tolerability of SAR113945 in Japanese patients with knee~     osteoarthritis after ascending single intra-articular doses~      Secondary Objective:~      To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis~     after ascending single intra-articular doses~   "
117994|NCT01511536|"~     Primary Objectives:~        -  To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel~          administered as a 1-hour infusion every 3 weeks in combination with oral daily~          abiraterone acetate and prednisone in participants with metastatic Castrate-resistant~          prostate cancer (CRPC)~        -  To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone~          acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.~      Secondary Objectives:~        -  To characterize the safety profile of the combination~        -  To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed~          combination and dosing schedule~        -  To assess preliminary antitumor activity of the combination in terms of~          progression-free survival, PSA progression free survival and objective response rate,~          and overall survival~   "
117995|NCT01511523|"~     A research study of a compound containing vitamin E, silymarin and carnitine, three over the~     counter supplements. The investigators hope to learn if the new supplement can safely and~     successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).~   "
117996|NCT01511510|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of ascending doses administered once daily for 14 days in healthy volunteers.~   "
117997|NCT01511497|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-04427429 in healthy women.~   "
118012|NCT01511302|"~     The purpose of this study is to determine whether RNS60, in combination with budesonide, is~     safe in mild to moderate asthmatics when taken by nebulization over a 28-day period,~     compared to a 28-day control period.~   "
117999|NCT01511471|"~     Clopidogrel administration is commonly prescribed in patients undergoing percutaneous~     coronary intervention, in patients with previous stroke and in patients under chronic~     hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel~     response compared to those with normal renal function. Ticagrelor is a new oral~     direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel~     responders and non-responders. It has also been shown that in patients with chronic kidney~     disease (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of~     cardiovascular death, myocardial infarction, and stroke greater than that of patients with~     normal renal function. Clopidogrel resistant patients as assessed by VerifyNow~     P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily~     for 15 days. Platelet reactivity will be determined at the end of the treatment period.~     Bleeding events, major adverse cardiac events and any side effects until Day 15 will be~     reported in a descriptive manner.~   "
118000|NCT01511458|"~     The purpose of this blinded, multi-center, prospective, case-controlled study is to compare~     the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester~     prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total~     hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in~     a general screened population.~      The performance characteristics of these two test modalities will be assessed relative to~     the clinical reference standard of genetic analysis of the fetus or phenotypic~     characterization and genetic analysis of the newborn.~   "
118001|NCT01511445|"~     This study randomizes neck and arm pain patients being treated with discectomy and anterior~     interbody fusion into two groups: one to receive a new ceramic implant and a control group~     with a more traditional plastic implant. The study will measure and compare pain and~     disability improvement with the two products over a period of two years. The fusion status~     will also be judged with plane x-rays and one CT scan.~   "
118002|NCT01511432|"~     The purpose of this study is to evaluate the relative bioavailability, safety, and~     tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.~   "
118003|NCT01511419|"~     The study hypothesis is that two doses of cold-adapted, live monovalent~     A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in~     healthy adults.~   "
118004|NCT01511406|"~     The purpose of the present study is to examine whether cognitive behavior therapy will~     reduce depressive symptoms and increase self-esteem for patients with a first episode~     psychosis.~   "
118005|NCT01511393|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish~     a registry for these new cases in order to identify any possible increase related to the~     introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into~     the US market.~   "
118006|NCT01511380|"~     This study is designed to gain knowledge about effective interventions for reducing HIV risk~     in a high risk population. A new Risk Reduction Therapy for Adolescents (RRTA) will be~     compared to usual services received by youth in juvenile drug courts. It is expected that~     youth treated with RRTA will show greater reductions in substance use and risky sexual~     behaviors. Reducing HIV risk by effectively targeting substance use and risky sexual~     behaviors in high-risk groups such as juvenile drug court-involved youth could favorably~     impact society at multiple levels (individual, family, peer, community, fiscal).~   "
118007|NCT01511367|"~     This is a comparator study to assess safety and efficacy of Flutiform compared with~     Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe~     persistent, reversible asthma.~   "
118008|NCT01511354|"~     The need for certain components of food (i.e. protein) for critically ill children is not~     clear. It is important to have critically ill children fed adequately to prevent that their~     condition becomes worse or that recovery takes longer. Research methods used in the past to~     investigate the need for protein (Nitrogen Balance calculations), were not sensitive enough~     in severely ill children. The purpose of this study is to develop a new research method to~     determine the need for protein in severely ill children. In order to develop this new~     method, more information is needed on the way the body of these children uses protein in~     24-hours. In the present study during 24-hours 8 children of age less than 18 years who are~     admitted to either the Pediatric ICU or the Cardiovascular ICU. Subjects will receive a~     standard nutrition, providing an age specific amount of protein (age ≤ 3: 2.52 protein g/kg~     BW.d; age 4-6: 1.8 protein g/kg BW.d; age > 10: 1.44 protein g/kg BW.d) via tube feeding.~     They will also receive a mixture of stable isotopes of amino to investigate protein behavior~     in the body (protein kinetics) both by infusion in their blood and together with the~     nutrition. Blood will be drawn every 60 minutes during the 24-hour period and the behavior~     of protein and the concentrations in blood of amino acids and urea will be measured. Urine~     will be collected to measure nitrogen balance. The investigators will compare the results of~     this nitrogen balance method with the results of the stable isotope method. PIM2, PRISM,~     SIRS criteria will be used to get information on the severity of illness of the subjects.~     Also body weight and length as well as body composition of the subjects will be measured at~     the start and after the 24-hour period. Body composition will be measured by Bioelectrical~     Impedance Spectroscopy. Endpoints of the study are net whole-body protein synthesis (protein~     balance), 24-hour pattern of protein balance, 24-hour urea production, 24-hour nitrogen~     balance, 24-hour contribution of arginine kinetics to whole body protein breakdown, 24-hour~     muscle protein breakdown, splanchnic amino acid extraction and plasma amino acid~     concentrations.~   "
118009|NCT01511341|"~     Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases~     of the locomotion system. The annual rate incidence of children diagnosed with rheumatic~     disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children~     experience a chronic course of the disease impacting on their quality of life and family~     functioning. Their medical treatment is significant and may last for life. Caring for these~     children involves a multidisciplinary approach. Control of the disease and management of the~     symptoms becomes of foremost importance to minimise disability and pain. In addition to~     medical care, the supporting role of nurses in the care of children with rheumatic diseases~     and their family aims to limit the potential for further deformity, disability, and~     psychological complications. In particular, they play a key role in supporting the~     specialist team caring for patients with rheumatism disease, recognising poor disease~     control and the need for changes in treatment, providing a resource to patients on treatment~     options and how to access additional support and advice, and identifying best practice to~     achieve optimal outcomes for the patients and their family. Nurses also ensure the link~     between medical practitioner, other health providers, and family, thus play a key role in~     the follow-up care of the child and its family. Follow-up of children and their family can~     be ensured by regular telephone consultation (telenursing) made by experienced nurse~     specialists in rheumatology. However, the effectiveness of telenursing remains to be proven~     in children with chronic rheumatic diseases. The aim of this study is, therefore, to~     evaluate the effect of a telephone nursing intervention on the outcomes of family and~     children with rheumatism chronic disease.~      This randomised crossover, experimental longitudinal study will be carried out in the~     outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of~     Vaud. The population will consist of children newly diagnosed with inflammatory~     rheumatologic diseases and one of their parent. The nurse-led intervention will consist of~     providing a monthly telephone call by a qualified and experienced nurse specialist in~     paediatric rheumatology and TN to ensure follow-up of the children and their family. The~     intervention will focus on providing affective support, health information, and aid to~     making decision.~   "
118010|NCT01511328|"~     The purpose is to evaluate whether implementation of primary human papillomavirus (HPV)~     screening in the screening programme for cervical cancer improves the programme in terms of~     better cancer protection and better cost efficiency.~   "
118014|NCT01511276|"~     Physical inactivity and overweight are two accepted risk factors for breast cancer. However,~     because of their correlation it is not clear which is most relevant to risk. The~     investigators now set out to study whether physical activity in addition to weight loss by~     diet only, affects sex hormone levels, known to be related to breast cancer risk.~      In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly~     allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight~     loss group or a control group. The aim of the first two intervention groups is to loose 5-6~     kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements~     are performed at baseline and after 21 weeks, the end of the study period.~      The aim of this study is to provide insight into the effect of weight loss mainly driven by~     exercise compared to equivalent weight loss due to nutritional calorie restriction on breast~     cancer biomarkers.~   "
118015|NCT01511263|"~     In a proportion of patients with AL amyloidosis there is no improvement of cardiac function~     despite hematologic response to treatment. The aim of the study is to assess whether~     treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis~     who completed chemotherapy.~   "
118016|NCT01511250|"~     The purpose of this study is to evaluate the safety and tolerability of a dengue vaccine~     administered subcutaneously in healthy adults and children. In addition the antibody~     response to the four dengue virus serotypes will be evaluated.~   "
118017|NCT01511237|"~     The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral~     prophylaxis intensification for the prevention of mother-to-child intrapartum transmission~     of HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during~     pregnancy.~   "
118018|NCT01511224|"~     Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in~     hospitals locally and worldwide. There is lack of prospective comparative clinical data to~     guide optimal strategy for treating such infections. Since it remains unclear how to treat~     bacteremia caused by AB, the present study aims to enroll patients at multiple sites with~     extensively drug resistant Acinetobacter species bacteremia receiving different combination~     therapy to assess treatment outcomes and analyze risk factors associated with mortality.~   "
118019|NCT01511211|"~     This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone~     to Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and~     popliteal block after total knee replacement surgery.~   "
118020|NCT01511198|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     determine the dose-response relationship for body weight and five escalating doses of NNC~     90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral~     hypoglycemic agent (OHA).~   "
118021|NCT01511185|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose~     concentrations in subjects with type 2 diabetes.~   "
118022|NCT01511172|"~     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect~     on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin~     given alone in subjects with type 2 diabetes previously treated with OHAs (oral~     hypoglycaemic agents).~   "
118023|NCT01511159|"~     This trial is conducted in Europe. The aim of this trial is to determine the relative~     bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when~     injected under the skin.~   "
118024|NCT01511146|"~     The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good~     options in patients with liver metastases. If the patients have colorectal cancer and never~     had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If~     the patient is K-RAS wild type the investigators will add cetuximab. In patients who had~     received oxaliplatin or in patients with other cancers the investigators will use mitomycin~     and gemcitabine together with capecitabine.~   "
118025|NCT01511133|"~     This study aims to test the clinical samples (stool and serum) previously collected during~     clinical development of HRV vaccine, to identify if there is any evidence of PCV-1~     replication and/or immune response to the PCV-1 in vaccinated infants.~   "
118026|NCT01511120|"~     The impact on fluid loading after cardiac surgery by use of two different priming solution~      Fluid overloading with oedema formation is a regular finding following on-pump cardiac~     surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been~     reported to impair both systolic and diastolic function. An association between~     intraoperative fluid loading and postoperative adverse outcome has been demonstrated in~     cardiac patients.~      The investigators have experience with the use of both colloides and combination fluids~     (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study~     the investigators used colloides as an additive to the CPB-prime. The investigators observed~     reduced fluid leakage and less total tissue water in several organs.~      The planned study includes patients scheduled for coronary artery bypass, and who have no~     co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated~     Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and~     diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume~     (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be~     monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.~   "
118027|NCT01511107|"~     The investigators will study whether, in young children with acute otitis media (AOM),~     shortening length of antibiotic treatment as a strategy for reducing antimicrobial~     resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter,~     randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through~     23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5~     days) with that of consistent standard-duration treatment (10 days) for each episode of AOM~     developing during a single respiratory season (October 1 through May 31).~   "
118028|NCT01511094|"~     The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as~     a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with~     good vision.~   "
118029|NCT01511081|"~     The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic~     body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT).~     Researchers would like to compare the side effects, quality of life, and cancer control.~   "
118031|NCT01511055|"~     Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete~     surgical resection, also known as a R0 resection. At present, the ability to perform a~     complete resection with negative margins is limited by the surgeon's ability to palpate and~     visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and~     costs while maintaining or improving surgical and oncologic outcomes, the investigators must~     develop technologies that improve visualization of the primary tumor and occult metastases,~     real time, during surgery. Recent research has demonstrated that the use of fluorescent~     probes that recognize cancer specific antigens can be used for this purpose when visualized~     using a prototype near-infrared multispectral imaging system.~      This investigation will determine if folate-FITC, a fluorescent probe that recognizes the~     folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and~     detect tumor nodules not visible to the naked eye.~   "
118032|NCT01511042|"~     The investigators are very excited that the National Institutes of Health are sponsoring us~     to investigate why patients with diabetes are more likely to develop high blood pressure,~     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our~     research program. The first part is a screening visit. At this visit you will be given a~     brief physical exam and will be asked questions concerning your medical history. During the~     same visit you will have your blood drawn for routine screening and to prepare DNA for~     genetic testing. You will also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II the investigators will perform physiologic~     tests after you are placed on a low salt diet and again after you are placed on a high salt~     diet. All of the food that you will eat during the two diets will be provided to you by the~     hospital. If you are on blood pressure medication, it may be necessary to discontinue taking~     your present medication for up to three months before beginning the study. Patients~     discontinuing their current blood pressure medication may be placed on a different blood~     pressure medication during this washout period if necessary to maintain blood pressure at~     pre-study levels. The investigators will take you off all medications, except cholesterol~     medications two weeks prior to your scheduled in-patient study. However, if you are~     currently on medication to control your diabetes you will remain on this throughout the~     entire study.~      Once your blood pressure medications are discontinued, you will be closely monitored to make~     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,~     the investigators will provide one for to use during the study so that you can keep a daily~     record of your blood pressure readings. The investigators will ask you to call us every~     three days to report your blood pressure readings. Less than 20% of patients with~     hypertension have any significant increase in their blood pressure during this short time~     off therapy. After you have been off your medication for nine days the dieticians will give~     you low salt meals to eat at home for six days. On the sixth day of the low salt diet, you~     will be asked to begin a 24-hour urine collection. You will also be required to come to the~     Ambulatory Clinical Center (221 Longwood Ave.) for a one-hour test. You will return that~     evening to the inpatient Clinical Research Center where you will be admitted for your first~     study that will occur the next morning. On the morning of your low salt study you will have~     three naturally occurring hormones administered and blood samples drawn from an intravenous~     needle. The investigators will also take ultrasound pictures of your heart to see how salt~     and hormones affect the way the heart functions. These tests will last approximately five~     hours and you will be discharged around 12:00 p.m. The dieticians will then give you your~     meals for the next week to take home. Each of these meals will have a high salt content.~     After six days of your high salt diet, on the morning of your second admission to the~     hospital, you will be asked to begin a final 24-hour urine collection. The same study that~     was done for the low salt study will be repeated for the high salt study. You will be~     discharged around 3:00 p.m. This study will determine if you are salt-sensitive. A high salt~     diet has been found to lead to higher blood pressure and weight gain. In addition, the~     investigators hope to learn more about the hormones that regulate your blood pressure and~     the genes responsible for regulating those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators will provide clinically~     relevant information to you and your physician.~   "
118033|NCT01511029|"~     To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to~     healthy volunteers.~   "
118034|NCT01511016|"~     HIV lipodystrophy syndrome (HLS) is characterized by loss of fat in the arms and legs,~     with increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have~     high risk for cardiovascular disease and diabetes mellitus and the metabolic syndrome. The~     investigators have previously shown that the abnormal lipid levels and lipodystrophy in HLS~     are associated with defective regulation of lipid metabolic rates, specifically, accelerated~     lipolysis (breakdown of stored fats), and decreased fat oxidation (utilization of fats for~     energy). Patients with HLS also have low levels of the hormone leptin. The investigators~     hypothesize that treatment of these patients with leptin will improve fat oxidation and may~     slow the rate of lipolysis. Hence, the investigators propose to study the effect of leptin~     therapy on lipid metabolic rates and lipid and glucose levels in adults with HLS. The~     investigators will use state of the art stable isotope tracer techniques and gas~     chromatography mass spectrometry (GCMS) to measure lipolysis, fat oxidation, and fat~     re-esterification in adipose tissues and liver.~   "
118035|NCT01511003|"~     This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis~     patients who showed unsuccessful response to existing DMARDs.~   "
118036|NCT01510990|"~     When considering 1st line gefitinib treatment for NSCLC, the investigators need epidermal~     growth factor receptor (EGFR) mutational status of the tumor. But most patients do not give~     us such information at the time of diagnosis, because it requires tumor tissue and some time~     period for EGFR examination. So, investigators develop a protocol of 1st line gefitinib~     treatment for NSCLC according to FDG-PET response. If a patient shows 20% or more decrease~     of peak standard uptake value (SUV) after 1 week's gefitinib treatment, he or she will be~     continued the treatment. If a patient shows less than 20% decrease of SUV, he or she will be~     switched to other chemotherapy.~   "
118037|NCT01510977|"~     Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper~     colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate~     bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as~     well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due~     to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with~     liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic~     antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second~     colonoscopy can be performed with either adding a colon cleansing solution immediately, or~     it can be performed after a few days with colon cleansing agent together with prokinetics.~     These different kinds of bowel preparations after first colonoscopy failure have not been~     compared.~   "
118038|NCT01510964|"~     The main aim of the study is to assess if a pre consultation intervention facilitates~     greater participation of patients (and accompanying key persons when present) in the~     consultation process by determining an increase in questioning and/or in the number of~     different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with~     the oncologist.~      Other aims are to assess the effect of the intervention on the oncologist's level of patient~     involvement, on patient satisfaction and coping and to explore the role of key persons~     accompanying the patient.~      The investigators expect that patients who have the opportunity to rehearse their~     informative needs before the consultation will ask a greater number of questions which in~     turn will determine their greater involvement by the physician and a greater number of~     satisfied needs. The investigators expect also that the straightforward use of a list of~     printed questions of potential relevance for cancer patients and their companions at an~     early stage of illness, by modifying the process of information exchange, increases their~     participation and satisfaction with the consultation, with potential benefits for treatment~     adherence and consequently treatment efficacy.~   "
118039|NCT01510951|"~     The purpose of this study is to assess the safety, tolerability, immunogenicity, and~     clinical effects of AMG 811 following single subcutaneous dose administration in subjects~     with moderate to severe psoriasis.~   "
118040|NCT01510938|"~     The purpose of this study is to assess the potential of probiotics in prevention of~     respiratory tract infections and their complications in children~   "
118041|NCT01510912|"~     The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the~     treatment of osteoarthritis pain of the knee or hip.~   "
118042|NCT01510899|"~     This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and~     safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single~     dose of RO4917838.~   "
118043|NCT01510886|"~     The main objectives of this study are to describe medical professionals responsible of the~     management of patients with MDD in a representative region of Andalusia (in terms of type of~     sites managing the disease, and referral to SC criteria); Describe MDD patient~     characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated~     to a higher incidence of referral from PC to SC.~   "
118124|NCT01509794|"~     As simulation is now used in many post-graduate education and assessment domains, the~     investigators want to learn about how autonomically engaged healthcare providers are with~     the investigators computer simulation paradigm. The investigators are interested in the~     relationship between autonomic arousal (as measured by heart rate variability and galvanic~     skin response), self-report of engagement, and performance in the simulation and cognitive~     debriefing.~   "
118044|NCT01510873|"~     Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising,~     menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of~     pITP patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed~     with pITP. The investigators project will aim at providing scientific community solid~     evidence based data on the extent to which HRQOL is compromised and in which specific area.~      The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL)~     profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of~     a matched Italian population control Group.~   "
118045|NCT01510860|"~     The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus~     Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).~   "
118046|NCT01510847|"~     The study hypothesis is that treatment with oral Testosterone according to the study regimen~     will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction~     in HbA1c levels at study day 90.~   "
118047|NCT01510834|"~     This project assesses the usability and feasibility of a multi-behavioral computerized,~     tailored intervention (CTI) or expert system delivered via the Internet for veterans with~     Post-Traumatic Stress symptoms. Three behavioral health risk factors, (1) smoking, (2)~     depression, and (3) stress, that are associated with Post-Traumatic Stress Disorder (PTSD),~     are included in the Computerized, Tailored Intervention (CTI) system. The project adapts and~     modifies an existing CTI system built on the Transtheoretical Model of Behavior Change (TTM)~     to make it relevant to a veteran population. The system has been successfully utilized with~     general adult populations. The study utilizes methods that are characteristic of a product~     development project. Each of the four project phases are sequential and build upon the~     results of the previous phase. Phase 1 focuses on the review of current CTI programs on~     smoking cessation, stress management, and depression prevention, and integrating them into a~     multi-behavioral program for application with veterans. Phase 2 includes the development and~     adaptation of text-based feedback messages and multimedia components for smoking cessation,~     stress management, and depression prevention for veterans. Initial testing of the modified~     CTI programs commences in Phase 3. Cognitive and usability testing with veterans are~     performed, and additional modifications to the behavioral modules are made based on the test~     results. Phase 4 focuses on a feasibility study to test the multi-behavioral CTI system with~     veterans online.~   "
118048|NCT01510821|"~     This is a single center prospective study of 30 patients undergoing elective heart bypass~     surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo~     study is to evaluate the function of vein grafts from small tissue samples treated with a~     pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the~     veins in preparation of bypass grafting. It is unknown if different levels of pressure in~     the syringe affect the vein or damage the vein. Small sections of tissue samples which are~     normally discarded will be obtained immediately after retrieval from the leg and before~     grafting to the heart. Tissue samples will be taken to the laboratory for study. There are~     no clinical endpoints in this study, however, clinical information will be obtained from the~     Society of Thoracic Surgeons database and will include demographics, risk factors, and~     perioperative outcomes.~   "
118049|NCT01510808|"~     Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive~     Periodontitis patients.~   "
118050|NCT01510795|"~     Chronic allograft nephropathy is one of dominant causes of long term kidney transplant~     failure. Its main histological determinant is interstitial fibrosis and tubular atrophy.~     Mechanisms of these changes are multifactorial and are not completely elucidated. Epithelial~     mesenchymal transition (EMT) might be one of the mechanisms. On molecular level role of~     renin angiotensin aldosterone system (RAAS) has been recognized. Recently, mineralocorticoid~     hormone aldosterone has been proposed as a possible direct contributor to the progression of~     renal injury and fibrosis, beside his well known role as a regulator of extracellular fluid~     volume and sodium and potassium balance. In this study the investigators will determine the~     impact of mineralocorticoid receptor antagonist use on progression of chronic scores in~     transplanted kidney over one year. The investigators hypothesis is that spironolactone use~     in kidney transplant patients will slow down progression of chronic histological changes-~     interstitial fibrosis, tubular atrophy and arteriolar hyalinosis.~   "
118051|NCT01510782|"~     To investigate safety and tolerability of BI 655064 in healthy male volunteers following~     intravenous infusion of escalating single doses and following subcutaneous injection.~     Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing~     and determination of the bioavailability of subcutaneous injections of BI 655064.~   "
118052|NCT01510769|"~     This study will compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous~     gout.~   "
118053|NCT01510756|"~     This is a Phase 2 trial to evaluate the activity of sorafenib in relapsed or refractory CLL~     patients with an iwCLL-WG indication to receive therapy.~      Sorafenib is an orally active multikinase inhibitor, which targets the RAF/MEK/ERK signaling~     pathway as well as several receptor tyrosine kinases. It is FDA approved for the treatment~     of hepatocellular carcinoma and renal cell carcinoma. Preclinical studies in the~     investigators laboratory demonstrated that sorafenib is cytotoxic to CLL cells.~      The primary objective of the study is to determine the overall response rate of Sorafenib in~     previously treated CLL patients. All patients will receive sorafenib at 400 mg twice daily~     continuously for three months and then assessed for response. Responding patients may elect~     to continue on treatment for an additional 9 months.~   "
118054|NCT01510743|"~     There has been no study comparing the complication rates between internal jugular vein~     catheterization and subclavian vein catheterization when they are performed using~     sonographic view. This prospective study would reveal the sort of complication and its rate.~   "
118055|NCT01510730|"~     The purpose of this study is to determine whether Helicobacter pylori eradication could~     reduce the new tumor development after endoscopic resection of gastric tumor.~   "
118056|NCT01510717|"~     The purpose of this study is to compare the safety and efficacy of an investigational~     multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.~   "
118057|NCT01510704|"~     To assess the efficacy and safety of different doses of APD421 in the prevention of~     post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of~     PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy~     (any surgical technique), cholecystectomy (any surgical technique) or other elective~     surgery scheduled to last at least one hour from induction of anaesthesia), requiring at~     least one overnight stay in hospital, and have at least 2 of the following risk factors for~     PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender;~     Planned opiate use for post-operative analgesia.~   "
118058|NCT01510691|"~     Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal~     membrane. Recently, in eyes with diabetic macular edema or persistent macular edema~     following retinal vein occlusion, vitrectomy will be increasingly performed as an additional~     treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the~     retinal oxygen saturation. However, little information is available about the oxygenation~     and the blood flow of the retinal vessels after vitroretinal surgery.~      Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in~     turn the most important factor for the development of macular edema. It is a major issue to~     improve the oxygen situation and the blood flow of the retina and there are just a few not~     satisfactory procedures available to overcome this problem. However, vitrectomy would be an~     adequate therapy for many of these diseases, and it would be an appreciated side effect of~     the treatment in almost every case.~      To investigate the influence of oxygenation and blood flow of the retina on clinical~     outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane,~     persistent macular edema following diabetic retinopathy or retinal vein occlusion.~   "
118059|NCT01510678|"~     Examine the effect of three different dietary messages on dietary intake and the health of~     parents and their children.~   "
118060|NCT01510665|"~     This is a prospective, randomized, placebo controlled study with three parallel arms~     examining the effects of magnesium supplementation in the second trimester of pregnancy.~      Recent research has shown that supplemental magnesium can have beneficial effects,~     especially in overweight individuals. Not only do many people have a magnesium deficient~     diet, there is also evidence that magnesium can improve blood sugar levels. Due to the~     growing concern of obesity with pregnancy and its associated complications, such as diabetes~     and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on~     pregnancy outcomes.~      In this study, 60 overweight and obese pregnant patients in their first trimester will be~     enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg~     elemental Magnesium), group B will receive dietary counseling about following a magnesium~     rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine~     specimens will be collected at three time points during the pregnancy to analyze changes in~     levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal~     and maternal complications of pregnancy will be noted, including maternal weight gain. At~     delivery, patients will have a placental cord blood specimen and placental biopsy collected~     for gene expression patterns and further analysis.~   "
118061|NCT01510652|"~     This investigation is designed with the hypothesis that using a quadripolar left ventricular~     lead results in less interventions when dealing with high pacing thresholds and Phrenic~     Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar~     left ventricular leads.~   "
118062|NCT01510639|"~     The purpose of this study is to test the hypothesis that the application of PRP leads to~     faster wound healing, less wound healing disorders, less pain and faster functional recovery~     after subacromial surgery.~   "
118063|NCT01510626|"~     The long-term goal of the investigators study is to develop a better and safer treatment~     for, and to potentially cure patients with single or multiple food allergies. The~     investigators hypothesize that the application of this protocol will allow patients with~     severe and single or multiple food allergies to be safely and rapidly desensitized.~   "
118064|NCT01510613|"~     The aim of the study is to evaluate the safety and efficacy of Pomalidomide and~     Dexamethasone in patients who did not achieve a complete response after initial treatment~     with both an alkylating agent (Melphalan or Cyclophosphamide) and Bortezomib. Patients who~     received 1 previous treatment without achieving a complete response (CR), but who could not~     be treated with alkylators and/or Bortezomib due to contraindications, will be included.~   "
118065|NCT01510600|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with high-risk~     neuroblastoma.~   "
118066|NCT01510587|"~     The main goal of this project is to develop, deliver, and assess the efficacy of a~     parent-centered educational program (4-Health) designed to prevent preteen children from~     becoming overweight.~   "
118067|NCT01510574|"~     Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An~     important strategy in the prevention of deaths is the use of uterotonic drugs for PPH~     prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is~     economical, heat stable, has a long shelf-life, and can be taken orally.~      The investigators envisage that the use of self administered misoprostol after home births~     among mothers would be associated with a peri-partum fall in hemoglobin value of over 20%~     (the outcome of a fall of 2g/dl will also be tested in the pilot).~      The objective of the main study will be to assess the effectiveness and safety of antenatal~     administration of misoprostol tablets (600mcg) for self administration immediately following~     home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot~     study are to test the integrity of the study protocol, to test the randomization procedure,~     to assess the acceptability of the intervention, to test the logistics of follow-up, to test~     the data collection forms, to validate the quality of life questionnaire in this population~     and to determine the recruitment rate to help study planning.~   "
118068|NCT01510561|"~     90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to~     assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and~     effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are~     then followed weekly for 12 weeks and afterwards for up to 1 year.~   "
118069|NCT01510548|"~     Aims:~      To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc~     prolapse will be will be compared up to 12 months after the start of study drug treatment.~      Study type:~      A one year,randomized, placebo controlled double blind single center trial.~      Patients and study drug treatment:~      The study population consist of 99 patients with sciatica caused by herniated disc prolapse.~      The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients~     randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study~     drug treatment period will be six weeks.~      Methods:~      Clinical evaluation, global assessments and Oswestry Disability Score and visual analog~     scale (VAS) will be used as the evaluation of clinical results with the disc prolapse~     patients confirmed by Magnetic Resonance Imaging. Health related quality of life will be~     assessed by 15-D questionnaire. Safety will be evaluated by medical examinations, adverse~     events (AE) collection and laboratory measurements throughout the study period.~   "
118070|NCT01510535|"~     The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once~     versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3~     weeks in the treatment of patients with osteoarthritis of the knee.~   "
118071|NCT01510522|"~     This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare~     the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients~     treated with Glucophage tablets.~   "
118072|NCT01510509|"~     Even though the safety of drug eluting stents has been long established, in roughly 25% o~     patients their implantation is not considered, for specifically clinical reasons (chronic~     anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A~     considerable percentage of these patients have diabetes mellitus, a well known risk factor~     for stent thrombosis. Recently, the special characteristics of the titanium stent with~     nitric oxide have been described, causing it to be considered as a bioactive stent.~      The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled~     clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal~     stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug~     eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic~     patients undergoing percutaneous coronary intervention.~   "
118073|NCT01510496|"~     The treatment of postoperative pain continues to be inadequate in the investigators practice~     setting.~      Inadequate pain treatment not only contributes to postoperative complications in the short~     term but can also be a factor that favors the development of chronic postoperative pain and~     diminishes long-term quality of life. Risk factors that can lead to a transition to chronic~     pain need to be analyzed.~   "
118074|NCT01510483|"~     This study will test an 18-month intervention designed to increase physical activity, reduce~     sedentary practices and promote healthy diets or reduce tobacco use and exposure among~     preteens who obtain orthodontic care. Relevance: If successful, this study may inform~     policies that would promote all specialists (orthodontists, physicians, general dentists) to~     deliver brief counseling for diet, physical activity, and tobacco prevention.~   "
118075|NCT01510470|"~     The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site~     maintains the marginal bone level~   "
118076|NCT01510457|"~     The patients are asked to take part in this study because you have chronic pain as a result~     of knee osteoarthritis. This study is done to investigate the pain relieving effects of the~     study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain.~     The purpose of this research is to look at how the study drug can be used to benefit people~     who experience osteoarthritis knee pain. This is a phase IV study done to study the safety~     and effectiveness of the drug. At this point the drug is already approved by the Food and~     Drug Administration for people with fibromyalgia but it has not yet been approved for people~     with knee osteoarthritis.~   "
118077|NCT01510431|"~     Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen~     Crohn's disease patients at participating centers who typically have already demonstrated~     good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and~     in the view of the investigator, would not benefit significantly from other Crohn's~     therapies but would benefit from use of PROCHYMAL.~      The study is not placebo-controlled or randomized.~   "
118078|NCT01510418|"~     The goal of this pilot study is to understand the socialization of adult men with hemophilia~     living in the United States and their quality of life in order to improve comprehensive care~     for persons with congenital bleeding disorders. Studies in Europe suggest that despite~     medical, surgical, and biotechnology advances in care for persons with the congenital~     bleeding disorders hemophilia A and B, men with hemophilia have earlier work disability and~     health-related lower quality of life than men of the same age who do not have hemophilia in~     the general population. Congenital bleeding disorders are known to have medical and~     psychosocial impact not only in school but also in other activities, e.g. participation in~     sports beginning at a young age. The psychosocial impact of living with a congenital~     bleeding disorder has been studied and described in childhood. The support relationships in~     childhood include parents and primary family of origin and these supports are generally~     considered in pediatric comprehensive care models. Support relationships in adulthood have~     not been well described or studied. The role of spouse and significant others (SSO) of PWCBD~     in health care is of interest for the delivery of adult comprehensive care as well as to~     understand their contribution to the health-related quality of life of PWCBD. Additionally,~     this study seeks to learn of the impact of congenital bleeding disorders for the SSO. The~     study uses self-reported medical and social information questionnaires, health-related~     quality of life surveys, and confidential interview. Results of this study may guide how~     comprehensive care and support are provided to adult persons with congenital bleeding~     disorders by hemophilia treatment programs. This study focuses on PWCBD with hemophilia A or~     B as a model for the experience of persons with other congenital bleeding disorders.~   "
118079|NCT01510405|"~     The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC)~     models the proteomic expression profile associated with exposure to Aurora and Polo-like~     kinase inhibitors. The identification of proteomic expression patterns in patients with~     NSCLC would be an important step in defining the possible role of these agents as potential~     targeted therapies for this clinically important disease. This study proposes to evaluate~     resected non-small cell lung cancer specimens for these proteomic expression profiles.~   "
118080|NCT01510392|"~     The primary goal of the trial is to show that optical coherence tomography (OCT) technology~     can be used to effectively screen for diseases of the eye including glaucoma, macular~     diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is~     usually accompanied by increased eye pressure. Macular diseases affect sharp, central~     vision. Keratoconus is a disease that affects the cornea (clear surface covering the colored~     part of the eye).~   "
118818|NCT01500928|"~     The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0)~     micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for~     their treatment.~   "
118081|NCT01510379|"~     The effect a ReletexTM device has on postoperative nausea and vomiting when used with~     ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved~     wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to~     decrease nausea and vomiting. The investigators will randomize 100 patients who are having a~     fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or~     Heller Myotomy for achalasia into two groups. A control group will receive scheduled~     ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan~     as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days.~     These patients will also get scheduled ondansetron and phenergan as needed, like the control~     group. The investigators will compare nausea, retching, and the amount of supplemental~     nausea medication used between the two groups. The patients will be provided a diary to~     document their nausea, retching, and medication use.~      The hypothesis of this study is that use of the ReletexTM device will reduce post-operative~     nausea and vomiting, and will reduce post-operative use of anti-emetic medications in~     patients who have undergone foregut surgery.~   "
118082|NCT01510366|"~     Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the~     objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated~     Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).~   "
118083|NCT01510353|"~     The purpose of this study is to examine the impact of using a real time radiation exposure~     monitoring device on the patient and operator radiation exposure during cardiac~     catheterization. The hypothesis of the study is that use of a real time radiation exposure~     monitoring device during cardiac catheterization will decrease both patient and operator~     radiation exposure compared to no use of the monitoring device.~   "
118084|NCT01510340|"~     The purpose of this study is to evaluate the efficacy of an online virtual intervention in~     optimizing adherence to antiretroviral medication intake among Persons Living with HIV~     (PLHIV).~   "
118085|NCT01510327|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions are located in vessels that are~     average-sized.~   "
118086|NCT01510314|"~     The clinical symptoms of septic complications (SC) (responsible for the majority of~     morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas~     the efficacy of treatment depends on early diagnosis. By detecting such complications early~     it could be possible to reduce their severity, the length of hospitalisation, repeat~     colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) >~     125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin~     (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up~     of elective surgery, particularly colorectal surgery, has not been fully evaluated.~      The aim of this study is to compare the ability of CRP and PCT to detect SC as early as~     postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC)~     after elective colorectal surgery.~      Adult patients about to undergo elective colorectal surgery with anastomosis will be~     included once they have given their written informed consent. Levels of CRP and PCT will be~     measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data~     (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily.~     Imaging examinations will be performed at the discretion of the surgeon; the only obligation~     will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with~     no other clinical anomalies. The discriminating ability (measured by the area under the ROC~     curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be~     necessary to show the superiority of PCT over CRP in clinical terms and with regard to the~     cost.~   "
118087|NCT01510301|"~     The purpose of this study is to examine if a mobile phone-based self-report system, using~     the patient's own mobile phone, will improve adherence to treatment of hypertension and lead~     to personal involvement of the patient in the treatment.~   "
118088|NCT01510288|"~     Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have~     demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this~     combination have demonstrated potent synergy. The purpose of this study is to investigate,~     using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and~     efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic~     prostate cancer (CRPC) patients.~   "
118089|NCT01510275|"~     In a rehabilitation setting, respiratory muscle training with re-expansion techniques in~     patients following cardio-thoracic surgery represents a consolidated intervention. New~     devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with~     an effect on respiratory muscle performance and perceived dispnoea. The aim of the~     investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients~     with a recent history of cardio-thoracic surgery.~   "
118090|NCT01510262|"~     People who present repeatedly at Sexually Transmitted Infection (STI) clinics represent a~     key population for HIV prevention intervention research. Despite their heightened risk there~     is an absence of empirical research on strategies to intervene with repeat STI. Some~     STI-clinic based behavioral HIV prevention studies, focusing on the general STI patient~     population, have found that risk reduction interventions can reduce the incidence of a~     subsequent STI. Studies have shown that expedited treatment for STI patients' partners can~     reduce subsequent STI and enhancing partner notification can reduce risk for repeat~     infection. Those who go on to experience repeat infections, after they are provided with~     risk reduction services, are the focus of this project. Repeat STI literature noted, there~     have been no intervention studies conducted to lower STI/HIV risk specifically among people~     who are presenting with repeat STI.~      The proposed study develops a risk reduction intervention designed for STI repeaters and~     evaluates the efficacy of this intervention and its cost-effectiveness. The investigators~     expect that the intervention for STI repeaters will be significantly more effective than~     standard care with regard to reducing participants' STI/HIV risks. However, even a~     highly-effective intervention is unlikely to be adopted if the outcomes come at a high cost.~     Administrators need to know how effective a new intervention is, but also if it is more~     cost-effective than the program it replaces.~      Cost-effectiveness information also is critical to justify the new intervention to~     prevention funders (Milwaukee Department of Health), who are concerned not only with costs~     and effects, but also with the tradeoff between them. The proposed study will provide the~     comprehensive level of information about intervention effects and cost-effectiveness~     required by administrators and resource allocation decision makers to determine whether or~     not to fund or implement the intervention.~      Hypothesis 1. The investigators expect a greater reduction in unprotected vaginal and anal~     intercourse in the prevention case management compared to the standard care condition.~      Hypothesis 2. The hypothesis that the case management group will have a lower STI~     re-infection rate compared to the standard care group will be tested using each~     participant's repeat STI status over the 12 month FU period.~   "
118715|NCT01502059|"~     This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness~     of Pilates to treat low back pain.~      Hypothesis - the Pilates group will have best results than the control group (usual~     medicament treatment).~   "
118091|NCT01510249|"~     Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of~     heel and it makes walking limited or even impossible.~      The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy~     in patients with heel spur.~      The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel~     spur confirmed radiographically. The patients were randomly divided into two groups;in Group~     1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock~     wave procedure(6 treatments). The researchers assessed pain three times (prior to the~     therapy, after the first and then the second week of treatment). In order to do this they~     used a modified form of the Laitinen pain indicators questionnaire (results expressed in~     points) and VAS - visual analogue scale (results given in milimeters). The results were~     statistically analyzed. In the studied periods of time a decrease in pain was observed (both~     in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both~     the groups after the first week of treatment. Ultrasound and shock wave therapies show a~     comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has~     an advantage over ultrasound therapy. A smaller number of procedures is required to obtain~     comparable results, which makes the therapy less expensive. No side effects were observed~     during and after the treatment.~   "
118092|NCT01510236|"~     The overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help~     program via internet aiming at preventing development and maintenance of cancer-related~     emotional distress among adolescents with cancer.~   "
118093|NCT01510223|"~     This study examined the effect of a 5-day HFD supplemented with specific fatty acids on~     gastrointestinal transit, appetite, food intake and substrate utilization. Another novel~     aspect of this chapter was examining whether a subsequent 5-day period was sufficient to~     reverse the effects of high-fat feeding on the aforementioned parameters.~   "
118094|NCT01510210|"~     The objective of this study is to assess the risk profile in patients with atrial~     fibrillation, which represents the degree of changes in the atrial tissue and which can help~     predict in which patients rhythm control will be successful. This risk profile will consist~     of a combination of underlying (heart) disease and risk factors, measurements obtained from~     echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to~     guide type of rhythm control therapy in individual patients with atrial fibrillation.~   "
118095|NCT01510197|"~     The objective of this study is to assess the risk profile in patients with atrial~     fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and~     which can help to predict in which patients rhythm control will be successful. This risk~     profile will consist of a combination of underlying (heart) disease and risk factors, as~     measured with use of parameters obtained with echocardiography, circulating biomarkers and~     other relevant clinical data. Ultimately this risk profile can be used to guide type of~     (rhythm) control therapy in individual patients with atrial fibrillation.~   "
118096|NCT01510184|"~     The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with~     observation alone in patients who are in PET-negative complete remission after first-line~     R-CHOP or R-CHOP like therapy.~   "
118097|NCT01510171|"~     The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral~     antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI~     with bivalirudin monotherapy.~   "
118098|NCT01510158|"~     This study that compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who~     have had an inadequate response to allopurinol.~   "
118099|NCT01510145|"~     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution~     without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic~     solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to~     tolerability issues.~   "
118100|NCT01510132|"~     The purpose of this multi-center, open label, single arm, post-marketing surveillance study~     is to assess the safety of Travacom in patients with open-angle glaucoma or ocular~     hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other~     intraocular pressure-lowering (IOP) medication and when use of Travacom is considered~     appropriate.~   "
118101|NCT01510119|"~     This is an open labeled phase I dose escalation study of HCQ and RAD001 in patients with~     advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target~     population are patients with one to three prior treatments for advanced renal cell~     carcinoma. In the phase I portion a traditional 3+3 design will be used to determine the~     maximal tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001~     po 10 mg/day.~   "
118102|NCT01510093|"~     This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles~     of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with~     continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous~     glucose infusion. The order of treatment session will be randomised.~      Hypotheses:~        1. Secretion of endogenous insulin depends on exogenous insulin supply~        2. Secretion of endogenous insulin is depends on plasma glucose levels~   "
118103|NCT01510080|"~     In order to meet an existing lack of empirical studies in the field of cognitive behavioral~     therapy supervision, the present randomized controlled trial is aimed at comparing two~     different types of supervision. This study compares computer-assisted live supervision and~     delayed video-based supervision regarding efficacy and acceptance among therapists, patients~     and supervisors. The efficacy of supervision is defined on different levels such as change~     of psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the~     supervisee as well as therapeutic alliance, supervisory alliance and therapy outcome.~   "
118104|NCT01510067|"~     The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site~     database between the University of Pennsylvania and the University of Texas Southwestern~     (UTSW).~   "
118105|NCT01510054|"~     MiRNAs are single-stranded small non-coding RNAs that act on specific mRNAs to regulate the~     gene expression. Studies have suggested that miRNAs influence cellular activities in the~     uterus, including cell differentiation and embryo implantation.~      In assisted reproductive cycles, controlled ovarian stimulation (COS) results in~     supraphysiological steroid levels and is associated with very low luteinizing hormone~     concentration during the luteal phase, the peri-implantation and implantation period. Luteal~     phase support, administration of medication aimed at supporting the implantation process,~     has been a routine practice in in vitro fertilization (IVF) clinics. Luteal phase support~     with steroid hormone has been found to improve pregnancy rates when human menopausal~     gonadotropins were used in conjunction with GnRH agonists for ovarian stimulation and IVF.~     Reports on effect of steroid supplementation in GnRH antagonist protocols are limited.~      The proposed project is an extension of our previous study on Endometrial Luteal Phase~     Characteristics and Luteal Phase Support in Controlled Ovarian Hyperstimulation Protocols~     with Gonadotropin Releasing Hormone Antagonists. The significance of this study is based on~     the importance of luteal phase endometrial after COS for the process of implantation. The~     availability of oocycte donors in assisted reproduction technology programs offers a unique~     opportunity to study the impact of different stimulation protocols on the quality of the~     luteal phase. In addition, the oocyte donor model may allow us to evaluate the impact of~     different luteal support protocols directly on the endometrial preparation by histological~     as well as biochemical markers.~      Study design: Study subjects underwent ovarian stimulation according to a gonadotropin/GnRH~     antagonist protocol. All donors had a baseline measurement of serum follicle stimulating~     hormone (FSH) and estradiol levels on the second day of their menstrual cycles. Provided~     serum FSH levels were less than 10mIU/ml and E2 levels were less than 60pg/ml, ovarian~     stimulation was initiated with recombinant FSH. The daily dose was adjusted according to~     follicular development by serial transvaginal ultrasound and serum E2 response. A daily~     evening dose of ganirelix acetate was initiated on the 6th day of stimulation and continued~     through the day of human chorionic gonadotropin administration. When at least three~     follicles reached a mean diameter of 18mm, ovulation was triggered with a single dose of~     Human chorionic gonadotropin (hCG). Sonographically guided transvaginal oocyte retrieval was~     performed 34-36 hours after the hCG administration.~      Thirty endometrial biopsies from oocyte donors on their COS cycles will be used for the~     study. Study subjects have been randomized into 4 groups. Grp 1: day of retrieval, did not~     receive any luteal-phase support, which serves as base line; grp2: 3, 5 and 10 days after~     retrieval with no luteal phase support, which serves as control; grp3: 3, 5 and 10 days~     after retrieval, luteal phase support with progesterone in the form of vaginal suppositories~     starting from the day after retrieval; grp4: daily oral dose of 2 mg 17β-estradiol in~     addition to the micronized progesterone. Immediately after the endometrial biopsy all~     specimens were stored in liquid nitrogen tanks at -196°C.~      Total RNA will be isolated and microarray will be performed using an Illumina miRNA~     expression panel. Array results will be compiled and analyzed focusing on the following~     aspects: the target genes of prominent miRNAs, miRNA profile in relation to target gene~     pathways; miRNA expression profile in relation to endometrial dating and status; effect of~     luteal phase support on miRNA expression after ovarian stimulation. Minimum of 3 miRNA~     arrays will be run for each sample for the purpose of statistical analysis. A total of 30~     arrays will be needed for all samples from all groups.~      In this study, the investigators pose three questions: 1) How many and what types of miRNAs~     are in the endometrium during ovarian stimulation? This is to identify miRNAs and associated~     target genes that are relevant for endometrium receptivity; 2) Do levels of miRNA expression~     change during the luteal phase, or during the window of implantation? This is to examine the~     dynamics of miRNAs that are associated with remodeling process of endometrium; and 3) Do~     luteal phase support alter miRNA expression in the luteal phase? This is to investigate the~     steroid effect on miRNA regulation. The investigators hypothesize that many critical genes~     related to implantation are regulated by miRNAs. This research effort will potentially~     advance our knowledge of endometrial characteristics after COS and the impact of sex steroid~     supplementation. Overall the study should help better understand the genetic control of~     implantation. Completion of this study may also provide measurable scientific evidence and~     useful information for the management of IVF cycles.~   "
118125|NCT01509781|"~     The objective of this prospective randomized study is to perform qualitative and~     quantitative comparisons between the insertion of traditional suction drains (Arm: Suction~     drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture)~     following simplex mastectomy or modified radical mastectomy in the light of the total volume~     of withdrawn serum from wound cavity, the extent of early postoperative analgesic~     requirements and quality of life.~   "
118106|NCT01510041|"~     In patients with chronic obstructive pulmonary disease (COPD) breaths at an abnormally high~     lung volume causes the inspiratory muscle to operate at non-optimal lengths, which reduce~     their maximal contractile forces. In addition, causes non thoraco abdominal synchronize,~     reduced inspiratory muscle strength and is associated with dyspnea and decreased exercise~     capacity. For these patients inspiratory muscle training (IMT) is a widely employed form of~     rehabilitation also targeting the respiratory muscle. In addition, patients often experience~     shortness of breath and a decline in exercise tolerance, resulting in disability in the~     performance of activities of daily living (ADL). The aims of this trial are to evaluate the~     effects of inspiratory muscle training associated with aerobic training on strength and~     endurance of inspiratory muscle, thoracic abdominal synchrony, exercise tolerance and~     quality of life patients with COPD. To compare the responses with the effects of aerobic~     training plus exercises of the trunk and upper limbs, and stretching of large muscle groups~     of the trunk. To compare difference in the perception of dyspnea during the ADL set (Borg~     Scale) with perception of dyspnea self-reported in the Medical Research Council (MRC), the~     London Chest Activity of Daily Living (LCADL) and the Pulmonary Functional Status and~     Dyspnea Questionnaire - Modified version (PFSDQ-M) before start the protocol. To investigate~     changes on perception of dyspnea (Borg scale), metabolic and ventilatory responses during a~     standard set of ADL tasks after a physical training and to evaluate and compare changes on~     perception of dyspnea. The hypothesis are that the ventilatory efficiency during the~     performance of ADL and the dyspnea reported from borg scale, the LCADL and the PFSDQ-M that~     quantifies the functional performance (change in activity levels) are improved during the~     IMT in conjunction with general exercise training in patients with COPD. The MIT increases~     the strength and endurance of inspiratory muscle, the exercise capacity and the quality of~     life compared to the general physical training. However, compared to the thorax abdominal~     synchronizes, higher modification is verified in the general physical training group with~     specific exercise to torso, limbs and stretching of the higher muscle group.~   "
118107|NCT01510028|"~     The purpose of this study is to determine the safety of ascending doses of HGT-1110~     administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with~     metachromatic leukodystrophy (MLD).~   "
118108|NCT01510015|"~     This study evaluates the effects of psychological and pharmacological treatment of regular~     users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The~     participants will undergo psychological evaluation before and during treatment and follow up~     at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in~     order to evaluate the effects of treatment on dopamine turnover in the brain. A control~     group of psychiatric in-patients undergoing treatment for psychiatric illness with be~     recruited from Geha Hospital in Israel. It is predicted that successful treatment of regular~     users of cannabis will be resulted in improvement in anxiety, depression and psychotic~     symptoms as well as in upregulation of dopamine turnover in participants that will undergo~     brain imaging.~   "
118109|NCT01510002|"~     The purpose of this study is to determine whether prophylactic central neck dissection is~     beneficial for patients with papillary thyroid cancer staged preoperatively as node~     negative.~   "
118110|NCT01509989|"~     The treatment of systemic lupus erythematosus (SLE) may change in the future due to the~     availability of new biological treatments, especially monoclonal antibodies in patients with~     active disease. However, one of the main causes of treatment failure in SLE is the lack of~     treatment adherence since drugs don't work in patients who don't take them.~     Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and~     investigators have demonstrated that patients who do not take HCQ for a long time have~     undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe~     non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active~     disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients~     with a SLEDAI ≥12.~      Investigators will evaluate the importance of non-adherence to the treatment in a large~     population of SLE patients with active disease. This will be done with blood HCQ monitoring~     in a translational multicentric prospective study.~   "
118111|NCT01509976|"~     Triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and~     antifungal agent that is found in thousands of common household products, including~     deodorants, toothpaste, antibacterial soaps, cleaning products, kitchen utensils, bedding,~     socks, trash bags. The benefits of triclosan have not been proven except in reducing plaque~     and gingivitis when used in toothpaste. In this study, the investigators intend to look at~     whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as~     well as changes in certain blood hormone levels, including adipocytokines, androgens, and~     inflammatory markers. Changes in the gut microbiota have been associated with a variety of~     disease states such as inflammatory bowel disease, colorectal cancer. Additionally,~     reductions in the microbiome diversity have been associated with obesity.~   "
118112|NCT01509963|"~     The purpose of this study is to prospectively evaluate the combined use of the MSKCC~     nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients~     with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom~     additional axillary lymph node dissection (ALND) could be avoided.~   "
118113|NCT01509950|"~     Currently different materials are used to close the skin after a cesarean delivery,~     including absorbable suture, non-absorbable suture and staples. It is not known what is the~     best choice of material to close the skin after a cesarean section, but commonly staples or~     dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture~     may have a better cosmetic outcome than staples. The investigators hope to learn if there is~     a difference in pain both at suture/staple removal and 6 weeks postoperatively between~     Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also~     plan to look for differences in wound complications and patient satisfaction, as well as~     operating and removal times. This knowledge will be important in helping practitioners~     choose the closure technique at cesarean delivery.~   "
118126|NCT01509768|"~     The purpose of this study is to evaluate the natural course of disease progression in~     Mucopolysaccharidosis Type III (MPS IIIB) patients who are untreated to identify potential~     surrogate endpoints that may be utilized in future treatment trials of MPS IIIB using~     predefined assessments including standardized clinical, biochemical, neurocognitive,~     developmental, and imaging measures.~   "
118127|NCT01509755|"~     This trial is conducted in Europe. The aim of this trial is to establish the dose response~     relationship on glycaemic control of five dose levels of NNC90-1170.~   "
118128|NCT01509742|"~     This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC~     90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.~   "
118129|NCT01509729|"~     Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic~     treatment.~   "
118391|NCT01506284|"~     The aims of the present study are:~        1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of~          changes in oscillatory mechanics parameters~        2. To evaluate the mechanical properties of the respiratory system in terms of input and~          transfer oscillatory impedance in response to PEEP changes~   "
118114|NCT01509937|"~     It is hypothesized that bioimpedance spectroscope guided fluid management will help patient~     reach euvolemic status, and increase long term survival.~      Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia.~     Observational data using BIA methods showed that hypervolemic patients on maintenance~     hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided~     fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are~     to evaluate the outcome of BIA guided fluid management comparing with standard care.~      Design: This is a multicenter, prospective, randomized, controlled trial. Setting and~     Participants: More than 1300 participants from 16 clinical sites will be included in the~     study. The enrollment period will last 6 months, and minimum length of follow-up will not~     less than 36 months. MHD patients aged more than 18 years but less than 80 years who had~     been on MHD for at least 3 months and considered suitable candidates will be invited to~     participate in the study. Participants will be randomized to BIA arm or control arm using~     1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical~     Care D GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months~     in BCM arm.~      Predictors: BCM guided fluid management and fluid management using standard care.~      Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint~     between BCM arm and control arm. The secondary intent-to-treat analysis compares left~     ventricular thickness, blood pressure, medication, and incidence and length of~     hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke,~     peripheral arterial disease will be used as composite endpoint.~   "
118115|NCT01509924|"~     The purpose of this study is to determine whether Physical Activation on Prescription can~     help patients with TIA to become more physically active.~      One group will receives Physical Activation on Prescription (PaP)and the other group will~     receives usual care.~      And to identify if persons with TIA presents with cognitive impairments.~   "
118116|NCT01509911|"~     TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The~     investigational product Tl-118 comprises of four well-known active components. The therapy~     is administrated at a unique dosing regimen that was found to be effective and advantageous~     in terms of safety. The product is formulated as an oral suspension, conveniently~     administrated by the patients at home and not requiring medical staff assistance. This Phase~     II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in~     Gemcitabine treated Pancreatic Cancer patients~   "
118117|NCT01509898|"~     The aim of this study was to evaluate the effect of a dental water jet on initial~     peri-implant disease resolution.~   "
118118|NCT01509885|"~     The main goal of this research is to understand the neuronal mechanisms that mediate the~     development of spasticity and motor dysfunction after spinal cord injury. The investigators~     examine how neurons and neuronal circuits in an injured nervous system adapt to produce the~     uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients~     with spinal cord injury. One of the neurons that the investigators study is the motoneuron~     that excites the muscles of the limbs to produce movement. Previously, the investigators~     have shown that after spinal cord injury, the excessive and uncontrolled activity of~     motoneurons during muscle spasms is mediated, in large part, by the activation of calcium~     currents in the human motoneuron. In human patients the investigators have used recordings~     from single muscle fibres to estimate the contribution of these calcium currents in~     activating the motoneuron during muscle spasms. In this proposal, the investigators study~     why motoneurons recover these calcium currents and self-sustained activity after chronic~     spinal cord injury. Because the calcium currents require the presence of the monoamine~     serotonin (5HT) to activate, and this monoamine is greatly reduced after injury, the~     investigators examine if the calcium currents recover because the 5HT receptors become~     spontaneously active without the need for 5HT to bind to the receptor, which the~     investigators hypothesize to be one of the causes of spasticity after spinal cord injury.~     This research will pave the way to develop new pharmacological and rehabilitative therapies~     to both control spasticity after spinal cord injury and augment residual motor movements.~   "
118119|NCT01509872|"~     The investigators are interested in knowing whether a group-based, trauma-focused~     intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general,~     non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing~     post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social~     behavior among war-affected children in the Democratic Republic of Congo.~   "
118120|NCT01509859|"~     The purpose of the study is to Compare the stability of the fracture and pain after surgery~     by measuring the stride length and weight bearing on the operated leg. This study will~     compare these parameters between two different proximal femur nails used for fixing hip~     fractures.~   "
118121|NCT01509846|"~     This is a research study about an experimental (investigational) oral inactivated whole cell~     Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made~     to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and~     children living in developing countries experience the greatest consequences of this~     disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable,~     and develops an immune response. About 82 healthy adults, ages 18-45, will participate in~     this study. This study will require volunteers to stay in the research facility for several~     nights for the first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay~     overnight for the second and third doses. Participants will be assigned to receive 1 of 4~     vaccine doses by mouth. Study procedures include: stool samples, blood samples and~     documenting side effects. Participants will be involved in study related procedures for~     about 8 months.~   "
118122|NCT01509833|"~     This study is a prospective, randomized, parallel, controlled trial to assess the efficacy~     of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian~     stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI)~     treatment.~   "
118123|NCT01509807|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospitalization costs.~   "
118179|NCT01509079|"~     The Purpose of this study is to determine whether vitamin D3 supplements will decrease the~     muscle and bone pain that are reported by women who take Aromatase Inhibitors.~   "
118130|NCT01509716|"~     Aims: The investigators' primary objective is to assess both perceived and actual disease~     knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators~     hypothesize that actual disease knowledge is poorer than perceived. As the secondary~     objectives, the investigators will also assess the HRQoL and examine the association between~     level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize~     that HRQoL of pre-dialysis CKD patients is poorer than that of the general population while~     pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with~     poorer knowledge.~      Methodology: A survey was developed to assess both perceived and actual knowledge on five~     aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and~     its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL,~     the following questionnaires will be used - Kidney Disease Quality of Life-Short Form~     (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and~     Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main~     languages - English, Chinese and Malay. A standardized data collection form was developed to~     retrospectively collect demographic and clinical information from the patients' electronic~     medical records and patient charts. Descriptive statistics will be used to report all~     results.~   "
118131|NCT01509703|"~     The aim of this study is to gain knowledge about effects of high flow transnasal~     insufflation on various breathing parameters like intratracheal pressure conditions, CO2~     elimination, breathing frequency and tidal volume.~   "
118132|NCT01509690|"~     Patients with end-stage renal disease are most vulnerable in the early months following~     hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore~     Renal Registry showed high mortality rates in the first 3-12 months of dialysis.~     Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months~     of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the~     United States.~      Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a~     renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic~     is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to~     4 months after HD initiation to focus on and streamline the management of dialysis issues~     and complications. These interventions would help patients achieve goal therapeutic targets,~     as well as reduce hospitalization rates and mortality, thereby improving their clinical~     outcomes and self-reported quality of life, and could result in economic and cost savings~     for the patients and healthcare system. The purpose of this study is to determine if the~     multidisciplinary, intensive and collaborative management of our multiethnic Asian patients~     newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.~      Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional~     management. Information on demographics, medical/medication histories, laboratory data~     (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and~     diabetes), hospitalizations, deaths and medical costs will be obtained and compared between~     the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of~     Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support~     Scale and Health Services Utilization questionnaires. Data collection will take place at~     baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and~     follow-up period of 1 year.~   "
118133|NCT01509677|"~     The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets~     once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and~     additional in sputum and blood serum. Also data on safety status will be obtained.~      Patients to be included required to have moderate to severe COPD associated with chronic~     bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks~     maximum.~   "
118134|NCT01509664|"~     The investigators plan to test the effect of price reduction of fruits and vegetables and~     non-caloric beverages on food purchasing, food intake, body weight, and body composition of~     primarily single adult shoppers. One hundred subjects will be randomized to an experimental~     or control group for a 4 month period. In the experimental group, there will be an automated~     50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month~     period. The investigators expect to observe significant changes in food shopping and eating~     behavior during this period, which should lead to body weight and fat loss. Some of these~     new shopping patterns should persist in the last month of the study even though prices~     revert.~   "
118135|NCT01509651|"~     Although anticholinesterase reversal agents have been used in combination with~     anticholinergic drugs for over half a century, it has been suggested that they should be~     used with caution in patients with underlying cardiovascular disease. As sugammadex has no~     endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This~     selective relaxant binding agent is specifically designed to encapsulate rocuronium, which~     can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as~     the dose is increased.~      Some reports, however, suggest that sugammadex may have increased time to effect in some~     patient populations like the elderly, patients in intensive care and renal failure patients.~     A less dynamic circulation and increased transfer time to the effector site in these~     subjects are likely explanations for this effect. The present trial was designed to assess~     the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB~     in patients with heart failure.~   "
118136|NCT01509638|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospitalization costs.~   "
118137|NCT01509625|"~     This retrospective observational study is designed to assess the response to treatment with~     fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of~     progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in~     post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were~     treated with this medicinal product and at said dose after having progressed with a previous~     anti-estrogen therapy. During this study, a retrospective data collection will be carried~     out using the information contained in the Clinical History of said patients, provided that~     the treatment with fulvestrant at a dose of 500 mg and LD-500.~   "
118138|NCT01509612|"~     The investigators aim to investigate the validity of their previous results in a randomized~     prospective, placebo-controlled, double-blind, multicenter controlled evaluation of~     questionnaires in patients with advanced malignant tumors. The investigators plan to compare~     the treatment outcome (quality of life and survival) in tumor patients, receiving standard~     or add-on homeopathic treatment.~      The null hypothesis is that add-on homeopathic treatment does not create a benefit for~     cancer patients. In addition the investigators evaluate survival time.~   "
118191|NCT01508923|"~     This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC~     90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin~     secretion in subjects with type 2 diabetes.~   "
118139|NCT01509599|"~     Leg vein circulation problems can damage the skin of the lower legs, especially around the~     ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop.~     Inflammation is often present in the damaged skin. This study will test whether using a~     special low compression, cooling, boot-like gel wrap placed around the damaged skin of the~     lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis~     is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg~     elevation, compression stockings) intervention compared to a low compression non-cryotherapy~     sham wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the~     incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with~     Stage 4 and 5 venous insufficiency.~   "
118140|NCT01509586|"~     This nationwide telephone and mail- based research study will recruit 1,400 cigarette~     smokers who are not motivated to quit to test the effects of a marketed oral,~     non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track~     the participants' usage patterns of the smokeless tobacco product.~      Half of the participants will receive a new, potentially safer tobacco product during the~     first six weeks of the study, and half will not. During this six-week period, each~     participant will complete three brief phone interviews. After this first six week period,~     participants will complete 6 other brief follow-up interviews, where they will answer~     questionnaires about their smoking habits.~   "
118141|NCT01509573|"~     The research will examine the following Specific Aims:~      Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention~     program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening~     Intervention in Rwanda or FSI-R) using prior qualitative findings and CAB input.~      Specific Aim 2: To deliver the intervention to a small group of families to collect~     preliminary data on intervention feasibility, acceptability, and to further refine the~     intervention manual for the FSI-R.~      Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families.~      In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory~     analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is~     associated with improved caregiver-child relationships using measures of family~     connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R~     will demonstrate increases in protective processes compared to usual care controls not~     exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to~     determine the extent to which improved caregiver-child relationships are sustained four~     months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of~     the intervention, participants in the FSI-R will demonstrate increases in protective~     processes compared to usual care controls not exposed to the FSI-R.~   "
118142|NCT01509560|"~     In this prospective study is to examine whether the use of everolimus in patients after~     allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is~     appropriate.~   "
118143|NCT01509547|"~     This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.~     After assessment and inclusion into the study, participants will be randomized to receive a~     12-week double blind course of varenicline or placebo.~   "
118144|NCT01509534|"~     Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective~     in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of~     reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or~     implantable loop recorder (ILR). The outcome is measured either by the time to first~     syncopal recurrence or the total syncope burden.~   "
118145|NCT01509521|"~     The purpose of this study is to determine the impact of phenylephrine versus ephedrine on~     organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The~     organ perfusion is estimated by measuring the maternal cerebral oxygenation by~     NIRS(Near-infrared spectroscopy)and the foetal heartrate.~   "
118146|NCT01509508|"~     This trial is evaluating a public health intervention strategy trial which aims to reduce~     the incidence of HIV at a population-level.~      The proposed strategy is a two steps process:~        -  Extensive HIV counselling and testing, and comprehensive prevention programme among a~          target population~        -  Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.~      The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of~     all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in~     the population. This is a cluster randomised controlled trial with a total of 22 communities~     used as the units for randomisation. Enrolment of a population of 22 000 individuals among~     which 4 400 are expected to be HIV-Infected.~   "
118147|NCT01509495|"~     The purpose of this study is to measure impedance during inpatient treatment.~   "
118148|NCT01509482|"~     Insulin resistance in men can be the underlying major factor in reproductive abnormalities (~     chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic~     ovarian syndrome ( PCOS ) in women.~   "
118149|NCT01509469|"~     The purpose of this study is to determine whether ileal infusion of casein and sucrose can~     activate the ileal brake.~   "
118150|NCT01509456|"~     Mainly due to the absence of gravitational forces in weightlessness, astronauts suffer from~     an increased bone loss- negatively affecting health and vitality during a mission. The~     development of effective countermeasures to this loss includes many different aspects like~     sports but also nutrition.~      Alkaline salts, abundant in fruits and vegetables, have shown to have positive effects on~     markers of bone turnover of postmenopausal women but also men and younger adults. With the~     current study the effects of a potassium bicarbonate supplementation added to a~     standardised, strictly controlled, definite diet of healthy, young men, should be verified~     within 21 days of 6°- HDT- Bedrest- the goldstandard of simulating weightlessness within~     earthbound conditions.~   "
118192|NCT01508910|"~     The purpose of the study is to assess the safety and efficacy of targeted intramyocardial~     delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal~     symptoms in subjects with refractory angina and chronic myocardial ischemia.~   "
118193|NCT01508897|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of~     two formulations of liraglutide.~   "
118405|NCT01506102|"~     The purpose of this study is to establish reference values for thromboelastography (TEM-A)~     in healthy pregnant women during labor and 2 hours and 24 hours after delivery.~   "
118151|NCT01509443|"~     Overall goal: To apply the investigators' well defined simple, few-minute breathing/ mild~     physical exercise program and evaluate its efficacy/benefits for the improvement of~     clinico-immunological outcome in obese patients with asthma.~      Rationale & Hypothesis: Different breathing exercise regimens currently recommended are not~     well defined and in certain cases may worsen dyspnea or even trigger an asthma attack.~     Therefore, it is important to evaluate the overall usefulness of a breathing exercise as a~     therapeutic intervention of asthma. In this regard, the investigators have designed an easy,~     few-minute breathing exercise program as a treatment modality for asthma and to evaluate its~     efficacy in improving associated clinico-immunological symptoms. The investigators~     hypothesize that the investigators' well-designed breathing/mild physical exercise~     intervention for obese patients will help alleviate the stress and symptoms of asthma by~     reducing the chronic low-grade systemic inflammation and thus potentiate the beneficial~     outcome of medication to render a better control over the disease and to improve the quality~     of life in obese patients.~      Clinical relevance/Significance:~      The investigators expect that their exercise module will help reduce inflammation caused by~     asthma, and thereby relieving symptoms of asthma. If successful, this would allow regular~     individualized exercise module to be recommended as a part of therapy for people with~     asthma, which could possibly reduce the dosage as well as frequency of taking medicine that~     they need.~   "
118152|NCT01509430|"~     Head and neck cancer patients often experience a critical weight loss of around 10%~     following radiation therapy. Of this up to 70% is muscle mass and is an independent~     predictor of mortality, lowers muscle strength and functional performance. The purpose of~     this study is in a randomized controlled trial to investigate the effects of progressive~     resistance training (PRET) on changes in muscle mass, muscle strength and functional~     performance in head and neck cancer survivors. The investigators hypothesize that PRET has a~     positive effect on all primary endpoints and increases muscle mass, muscle strength and~     functional performance.~   "
118153|NCT01509417|"~     The objective of this study is to scientifically evaluate the ability to discharge patients~     based on feeding schedule comparing ad lib feeds to our current scheduled regimen.~      The hypothesis is that patients may be able to be discharged sooner with ad lib feeds.~   "
118154|NCT01509404|"~     The purpose of the study is to assess the incidence and severity of late Cytomegalovirus~     (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and~     200 days and after 200 days post-transplant in patients treated with valganciclovir per~     package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant~     versus valganciclovir per package insert guidelines for 100 days post-transplant with~     Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.~   "
118155|NCT01509391|"~     In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin~     in patients with chronic hepatitis c infection and liver cirrhosis. The investigators~     hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in~     patients infected with hepatitis c.~   "
118156|NCT01509378|"~     The aim of the study is to characterize and quantify the relative effectiveness and~     contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical~     outcomes under the conditions of daily practice.~      Swiss, multicenter, prospective, observational study.~   "
118157|NCT01509365|"~     The purpose of the study is to determine whether administration of 150 mg clopidogrel is~     effective in reducing the one-year incidence of thromboischemic events in patients with high~     on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population~     overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.~   "
118158|NCT01509352|"~     This is a prospective trial of the utility of esophageal stitches during fundoplication.~      The hypothesis is that recurrence rate may be different with or without the esophageal~     stitches.~   "
118159|NCT01509339|"~     The purpose of this study is to determine the pharmacokinetics and safety of inhaled~     vancomycin in patients with cystic fibrosis.~   "
118160|NCT01509326|"~     This study will investigate the effect of chiropractic treatment with and without the use of~     an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups~     with and without the pillow and will be followed for five weeks. The primary outcome measure~     will be headache frequency. The investigators predict that the group using the pillow on a~     daily basis will demonstrate significantly greater decrease in headache frequency over a~     5-week interval.~   "
118161|NCT01509313|"~     Outpatient polyp treatment can be performed in a few different ways but generally involves~     passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through~     which specifically designed miniature operating instruments are passed to remove the~     polyp(s). At present the most commonly used instruments use an electrical cutting edge.~     However, a new instrument using a mechanical cutting edge has come to market. In patients~     having a general anaesthesia the mechanical cutting instrument has been shown to be easier~     to learn, more effective at completely removing polyps and quicker. However, the instrument~     is slightly larger, which could potentially cause more discomfort and prolong the procedure~     in the outpatient setting. Therefore, the investigators want to compare the electrical and~     mechanical instruments for speed, completeness of polyp removal and patient acceptability.~   "
118162|NCT01509300|"~     RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide~     and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the~     setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition,~     T-cell depletion may contribute to prevent developing severe acute graft versus host disease~     (GVHD) in haploidentical transplantation.~      PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine,~     cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical~     donors in treating patients with acute leukemia and myelodysplastic syndrome.~   "
118163|NCT01509287|"~     This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).~   "
118250|NCT01508130|"~     This prospective observational study will evaluate the efficacy and safety of two approved~     pegylated interferon-based direct acting antiviral triple therapies in patients with chronic~     hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin~     plus either telaprevir or boceprivir in accordance with local standard of care and US~     labeling will be followed for the duration of their treatment and for up to 24 weeks~     post-treatment.~   "
118164|NCT01509274|"~     The purpose of our study is to determine whether one injection with plasma into the origin~     of the plantar fascia is an effective treatment of plantar fasciitis.~      90 patients will be randomized into three groups. 30 patients will be treated with one~     plasma injection, 30 patients will be treated with one injection with saline and 30 patients~     will do physiotherapy and use heel cups. The two groups who receive injections will do the~     same physiotherapy and use heel cups, as the conservatively treated group.~      Both groups randomized to receive an injection will have a 10 ml blood sample taken from~     their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are~     added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to~     receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The~     injection into to the origin of the plantar fascia i done 10 minutes after the sample of~     blood is obtained. The content of the syringe i blinded to both the investigator and the~     patient.~      The injection i performed from the medial aspect of the heel under guidance of ultrasound.~     No local/systemic analgetic is used. The content of the syringe is spread using peppering~     technique into the origin of the plantar fascia.~      Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The~     questionaires will be Foot Function Index and SF-36 as well as questions about their use of~     analgetics, use of heel cups and intensity of their physiotherapy~   "
118165|NCT01509261|"~     This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive~     esophagitis and resolution of heartburn.~   "
118166|NCT01509248|"~     1. Population pharmacokinetics : The purpose of this study is~           - to investigate the population pharmacokinetics of theophylline in premature Korean~          infants and to assess the influence of demographic and clinical covariates.~        2. Metabolomics : The purpose of this study are~             -  to predict serum theophylline levels and to assess CYP1A2 activities in premature~               infants by analyzing urinary metabolites of theophylline~             -  to examine which factors affect clearance of theophylline and CYP1A2 activity in~               premature infants~   "
118167|NCT01509235|"~     In the current study, we designed a cross-over, open label, randomized controlled clinical~     trial that aim to investigate the superiority of physical exercise coupled with self~     drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that~     CF children undergoing physical exercise coupled to self drainage will increase the amount~     of expectorate secretions compared to conventional CP course, while being more satisfied and~     without worsening their pulmonary function status.~   "
118168|NCT01509222|"~     The main objective of this study is to investigate the effect of a personalized nutrition~     intervention on the dietary pattern of apparently healthy adults with one or more children~     aged 4 to 12 years.~   "
118169|NCT01509209|"~     The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the~     treatment of vasomotor rhinitis~   "
118170|NCT01509196|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HIP0901 capsules and Lipidilsupra tablets.~   "
118171|NCT01509183|"~     Asthmapolis is collaborating with Catholic Healthcare West (CHW) to carry out a focused~     demonstration project to evaluate the effectiveness and potential cost savings of a~     deployment of the Asthmapolis approach to asthma management. The Asthmapolis goal is to~     bring together the best technology and asthma insight in order to provide CHW with an~     engaging, data-driven chronic care program to improve asthma management and lower healthcare~     utilization costs, and to respond to prevention-focused reforms to health insurance laws.~      This project has been designed to implement and evaluate a data-driven program to improve~     asthma management and control and lower direct costs through reductions in healthcare~     utilization. This program has been developed by Asthmapolis and has gone through preliminary~     testing. Each subject participating in the study will receive an Asthmapolis device, which~     captures the time and location of use of inhaled short-acting bronchodilators over a~     twelve-month period. This information is processed and delivered at regular intervals to the~     patient and his or her provider to support improved asthma management.~      The purpose of the study is to evaluate the impact of the adoption of the Asthmapolis system~     into a healthcare organization, and to provide sufficient information to inform decision~     making for potential future adopters. The researchers believe that the Asthmapolis system~     has the potential to improve asthma control by providing rescue inhaler actuation data and~     tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler~     actuation data to their providers. Improvements in asthma control should be reflected in~     reductions in healthcare utilization for asthma, and potentially for general healthcare~     utilization. Reductions in utilization would result in lower healthcare costs. The study has~     been designed to capture data on individual subject asthma control, and changes in~     utilization and costs over a one-year introduction period.~   "
118172|NCT01509170|"~     The aim of this study is to identify factors associated with hyponatremia among patients~     hospitalized in the internal medicine ward. Consequtive patients hospitalized because of~     hyponatremia will be recruited. Follow up will include clinical factors such as background~     diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal~     function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on~     addmition. One month following discharge follow up Sodium level will be taken.~   "
118173|NCT01509157|"~     The investigators have developed a unique Remote & Safety diabetes management system (MDRS)~     that offers real-time remote monitoring and control of glucose levels. The system allows the~     supervising personal to alarm the patient and intervene in cases such as pending~     hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility~     study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in~     children and young adults with type 1 diabetes.~   "
118174|NCT01509144|"~     Objectives:~        -  To assess the safety of three priming immunisations by nasal route followed by two~          booster immunisations by intramuscular route~        -  To assess immunogenicity responses induced by the vaccine.~   "
118175|NCT01509131|"~     It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar~     bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and~     compliance of the two reduced volume PEG-based bowel preparation will be also compared.~   "
118176|NCT01509118|"~     Arterial and venous thromboembolism represents one of the most common preventable health~     problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for~     deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis,~     the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is~     reportedly 4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is~     recommended.~   "
118177|NCT01509105|"~     It is an observational multi-center study to assess the safety profile of Prevenar13 used~     among Korean children in the routine clinical setting following a licensure and introduction~     of the vaccine. This study is designed to fulfill regulatory requirement for any new drug~     authorized by KFDA.~   "
118178|NCT01509092|"~     The purpose of this study is to compare the anatomical and visual recovery of eyes with~     traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.~   "
118180|NCT01509066|"~     This study will be a 6-month intervention that is examining how different dietary approached~     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting~     pregnancy, particularly by measuring changes in weight. Participants will be randomly~     assigned to following one of two dietary approaches for weight loss: 1) a low-calorie~     approach to weight loss (reducing caloric intake by approximately 500 calories per day) or~     2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any~     animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods,~     such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be~     low-glycemic index, which means you will be asked to favor foods that don't cause a quick~     rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast).~     Participants will receive counseling and supporting materials on the dietary approach you~     are assigned to follow. Both diets are safe and have shown to be effective ways to assist~     with achieving a healthy weight. The investigators hypothesize that both groups will see~     improvements in weight and fertility with possible greater improvements seen among~     participants in the vegan group.~   "
118181|NCT01509053|"~     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic~     patients treated with oral antipsychotics to prospective hospitalization rates of these~     patients treated with IM depot aripiprazole.~   "
118182|NCT01509040|"~     ﻿The purpose of this study is to assess the feasibility of hemofiltration in patients~     resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the~     heart including the loss of detectable pulse, or spontaneous breathing. When heart function~     is restored, the cells of the body release molecules into the blood that cause inflammation,~     unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of~     washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy~     for renal failure, but is considered investigational for treatment after resuscitation from~     cardiac arrest. Some experts believe that hemofiltration after heart function is restored~     can remove inflammation from the blood, maintain blood pressure and organ function. Others~     believe that intravenous fluid and medications are sufficient to maintain blood pressure and~     organ function. Since the inflammation that occurs after restoration of heart function~     lasts, the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration~     or intravenous fluids and medications is better is not known. The investigators are checking~     if they can wash the blood of patients resuscitated from cardiac arrest before the~     investigators can begin a large randomized trial to test whether hemofiltration improves~     their outcome.~      The investigators are testing this by randomly allocating patients resuscitated from cardiac~     arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous~     fluids and medications alone. The null hypotheses are that less than 80% of eligible~     patients will be enrolled, and that less than 80% of enrolled patients will undergo~     low-volume or high-volume hemofiltration (HF) for at least 80% of 48 hours.~   "
118183|NCT01509027|"~     Hyperphosphatemia is a common and severe complication in chronic kidney disease patients~     treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the~     cornerstones in the prevention and treatment of this complication. However, noncompliance is~     an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial~     proportion of hemodialysis patients. The present study aims at identifying risk factors for~     non compliance and also test the hypothesis that compliance can be improved by education~     patients on the consequences of hyperphosphatemia and the importance of diet and phosphate~     binder therapy.~   "
118184|NCT01509014|"~     Despite proven benefits in reducing morbidity and mortality, many patients become~     nonadherent to statin therapy within the first year of starting. Due to their accessibility~     and frequent patient contact, pharmacists are well-positioned to improve medication~     adherence.~      The purpose of this study is to determine whether a simple intervention by community~     pharmacists can improve statin adherence in new statin users.~   "
118185|NCT01509001|"~     Aim:~      The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on~     vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type~     2 diabetes.~      Methods:~      A prospective study will be performed in 20 uncontrolled patients previously treated with~     dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8~     mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to~     the alternative treatment for an additional 4-month period on similar dosage schedule.~        -  The following variables were assessed before (basal values) and after 4 months of each~          treatment period:~             1. Hormonal and metabolic determinations: fasting plasma glucose, insulin,~               catecholamine, lipid profile and HbA1 levels.~             2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity,~               platelet aggregation, fibrinogen and plasminogen levels.~             3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at~               the end of each treatment period, a 12-hour metabolic profile including~               measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at~               fasting and every 2 hours (7:00 am to 7:00 pm)will be done~   "
118186|NCT01508988|"~     The primary objective of this study is to evaluate the safety and tolerability of ascending~     single doses of ONO-9054 administered as a single drop in healthy adult subjects. The~     secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and~     its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.~   "
118187|NCT01508975|"~     The investigators hypothesize that consumption of either white or brown rice will be more~     satiating than glucose control.~   "
118188|NCT01508962|"~     The goal of PRESS-ALS is to study the earliest manifestations of disease in people with~     early ALS in whom some areas of the body are not yet affected.~   "
118189|NCT01508949|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC~     90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated~     with diet and/or sulphonylurea or repaglinide.~   "
118190|NCT01508936|"~     The primary objective of the study is to characterize the efficacy of reslizumab treatment,~     at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in~     improving pulmonary function in relation to baseline blood eosinophil levels in patients~     with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced~     expiratory volume in 1 second (FEV1).~   "
118194|NCT01508884|"~     Despite the WHO International Health Regulations Emergency Committee declared an end to the~     2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has~     affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic~     underlying illness and extreme of ages are at risk of developing severe disease and~     complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore,~     vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like~     virus incorporated will be the best protection against the influenza infection, especially~     among the at risk population. Recent study on dose sparing seasonal influenza vaccine~     delivered via a novel intradermal microneedle has demonstrated good immunogenic responses~     similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009~     component of the trivalent influenza has been reported [7].~      Study has also suggested the combined intradermal vaccination with local stimulation of~     dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site,~     which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may~     produce better immunogenicity [8].~      Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma.~     Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is~     processed and presented to cells of the adaptive immune system leading to clearance of the~     virus and subsequent clearance of the lesions [9]. In addition to functional maturation,~     imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes~     [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with~     the antigen of interest, has shown to induce enhanced responses towards the administered~     antigen [12].~      We therefore performed a prospective, double blind, randomized controlled study to compare~     the safety and immunogenicity between intradermal 2011/2012 TIV immunization with~     pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV~     immunization with pretreatment of aqueous cream as control.~   "
118195|NCT01508871|"~     This study will evaluate the relationship of markers of cardiac activation and their~     determinants. The hypothesis is that these markers will be interrelated.~   "
118196|NCT01508858|"~     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide~     changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a~     combination contraceptive drug (Neovletta®).~   "
118197|NCT01508845|"~     This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs.~     poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken~     after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat~     is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will~     be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA~     ratio.~   "
118198|NCT01508832|"~     The duration of the autonomic (sympathetic) block will last longer than the sensory block.~     The duration of the increased perfusion index will last longer than either the sympathetic~     or sensory block.~   "
118199|NCT01508819|"~     Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most~     difficult clinical challenges in medicine. There are few data to help guide clinicians in~     this area: estimates of the benefits of ICU admission, especially in the very elderly, are~     sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.~      The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of~     patients over 80 arriving in Emergency Departments (ED) with conditions that potentially~     warrant ICU admission and their outcome six months after ED visit. Overall rate of patients~     deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but~     ranged from 5% to 38% across the participating centers. This variability persisted after~     adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance~     18%). The analysis also revealed that high functional status prior to ICU visit, good~     nutritional status as assessed by an emergency physician and the absence of cancer were of~     good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED~     with a life-threatening condition and all positive prognostic factors mentioned above were~     admitted to an ICU in the ICE-CUB1 study.~      Hypothesis Elderly patients visiting the ED with a life-threatening condition, high~     functional status prior to ICU visit, good nutritional status as assessed by an emergency~     physician and no cancer will potentially benefit from ICU care and should thus be admitted.~      Main objective Determine whether a strategy consisting of recommendations of ICU admission~     of all patients over 75 visiting the ED with a life threatening condition, no cancer, good~     functional and nutritional status prior to ED visit decreases the mortality of these~     patients six months after ED visit.~      Secondary objective : Assess the impact of the strategy on:~        -  In-hospital mortality~        -  Rate of ICU admission~        -  Place of living and quality of life six months after ED visit~      Primary outcome :Mortality six months after ED visit Secondary outcomes~        -  In-hospital mortality~        -  ICU admission~        -  Change in functional status six months after ED visit~        -  institutionalization~        -  Quality of life six months after ED visit~   "
118200|NCT01508806|"~     This trial is conducted in Oceania. The aim of this trial is to assess whether dose~     adjustment is required for patients with renal impairment by investigating the~     pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.~   "
118201|NCT01508793|"~     The proposed study aims to determine whether an intervention to increase sleep in school-age~     children is associated with positive changes in eating, activity behaviors and zBMI. One~     hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly~     assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce~     a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in~     sleep). Families of children in the optimize sleep group will be taught effective behavioral~     strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month~     follow-up, the following will be gathered: sleep duration (measured by actigraphy), food~     intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry),~     the relative reinforcing value (RRV) of food (measured using a validated experimental~     paradigm), and measured child height and weight.~   "
118202|NCT01508780|"~     It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular~     remodeling. The investigators believe that this study will help document the nature of~     beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in~     response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular~     structure and function accompany clinical improvement.~   "
118203|NCT01508767|"~     Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone~     tube) placed in the bladder at the time of operating to monitor kidney function during~     surgery and in the post-surgery period. Such patients will also have an infusion into the~     spine, known as an epidural, after surgery to provide them with continuous pain relief.~     Urinary catheters should be removed as early as possible once they are no longer required to~     facilitate patients becoming mobile after surgery and to reduce the risk of patients~     developing a urinary tract infection.~      Traditionally these catheters are not removed until the patients epidural infusion is~     withdrawn, as in theory to do so would predispose the patient to developing acute retention~     of urine due to lack of sensation when the bladder is full. The investigators hypothesis is~     that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal~     surgery in patients receiving epidural pain relief without a significant increase in rates~     of urinary retention.~   "
118204|NCT01508754|"~     The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure~     (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive~     patients with moderate-severe obstructive sleep apnea syndrome (OSAS).~   "
118251|NCT01508117|"~     The purpose of this study is to determine whether the addition of an investigational~     medication, axitinib, to radiation therapy will improve the outcome of treatment in~     patients, above the age of 70.~   "
118205|NCT01508741|"~     PURPOSE: The purpose of this investigation is to determine if a relationship exists between~     the administration of a dietary supplement containing 5-ALA and sleep and mood.~      HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one~     study involving test mice, researchers found that the regular administration of 5-ALA~     appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin~     levels, 5-ALA may contribute to improvements with sleep, along with additional improvements~     in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal~     regulation, including melatonin, in the pineal gland and corticosteroid regulation in the~     adrenal glands.~      Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism~     of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal~     function and assistance with mental energy needed to deal with stress in daily life,~     producing better feelings of coping, less irritability and lowering an individual's~     feelings of fatigue, all of which may contribute to a reduction of pessimism regarding~     the ability to deal with daily tasks.~      DESIGN: This will be a double-blinded, randomized parallel-group comparison study.~      SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome~     variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20~     participants. A table of random numbers will be used to assign the participants.~   "
118206|NCT01508728|"~     Ortheses are commonly used for the repair of damage to the musculoskeletal system. However,~     immobility, by itself, causes serious side effects that require long and costly~     rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the~     proprioceptive and tactile flow in order to maintain the activity of their host brain areas~     and thus reduce significantly the usual therapy duration. The clinical study Orthosens will~     evaluate the efficacy and safety of the Sensory Feedback Ortheses.~   "
118207|NCT01508715|"~     The purpose of this study is to compare two different physical therapy exercise programs in~     persons who have shoulder pain in order to determine if they have a different affect on pain~     level and ability to use the injured shoulder after treatment. Both exercise groups will~     attend physical therapy for an hour,two to three times a week, for eight weeks. The first~     two weeks of therapy sessions will involve learning the exercises and testing to determine~     what weight to use during exercises. One group will perform a traditional therapy exercise~     program for shoulders using hand weights. The other group will perform a version of the same~     shoulder exercises but with a different exercise technique. Exercises in both programs are~     part of the standard of care for shoulder impingement in physical therapy but one program~     concentrates on the lowering portion of the exercise (eccentrics) while the other emphasizes~     the lifting portion of the exercise (concentrics). Both groups will perform the same~     warm-up, stretching, and cool-down exercises. Participants will also be required to perform~     a daily home exercise program of stretches and range of motion that will take about 20~     minutes to complete. Exercise testing will determine the hand weight resistance used by each~     person during their therapy sessions and re-testing will occur every two weeks to determine~     any changes in the weight used for the exercises to keep them challenging. Pain level,~     ability to use the injured arm for daily activities, strength, and amount of movement in the~     shoulder, will be measured at the start of physical therapy and after five and eight weeks~     (end of study) of the exercise treatments. A concurrent study investigating the reliability~     of the shoulder motion and strength measurements used in the larger study will also be~     performed.~      Research hypotheses:~        1. Adults with shoulder pain who complete the eccentric progressive resistive exercise~          intervention will demonstrate significantly greater improvements in the outcome~          measures at three weeks, earlier in the intervention, than the concentric progressive~          resistive exercise intervention group.~        2. Adults with shoulder pain who perform progressive resistive exercise interventions,~          regardless of contraction type, will demonstrate significant improvement in the~          shoulder outcome measures at three and six weeks of intervention.~   "
118208|NCT01508702|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad compared~     to placebo in patients who are intolerant or have a contraindication to allopurinol or~     febuxostat.~   "
118209|NCT01508689|"~     The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars~     will increase calcium intake in healthy adult women.~   "
118210|NCT01508676|"~     The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain~     felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2~     weeks.~      The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis~     (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.~      The research study will compare Pennsaid to placebo.~   "
118211|NCT01508663|"~     The primary purpose of this study is to determine whether PCI added to OMT could be superior~     over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in~     elderly patients with coronary artery disease (CAD) during the additional 12 months.~   "
118212|NCT01508650|"~     Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart~     Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to~     establish the feasibility of conducting a larger clinical trial to address the hypothesis~     that, in addition to standard care, a novel, progressive, multi-domain 3-month~     rehabilitation intervention administered to elderly patients with acute decompensated heart~     failure (ADHF) will improve key clinical outcomes, including the rate of rehospitalization~     and death, physical function, and quality of life.~   "
118213|NCT01508637|"~     Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated~     diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system~     a trial of alpha-blocker terazosin is also used. Each participant completes four study~     sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at~     300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure);~     2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter~     air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial~     artery ultrasound, and plasma measures of endothelial activation. The investigators~     hypothesize that DE exposure will be associated with increased blood pressure, decreased~     brachial artery diameter, and increased circulating endothelins, and that these effects will~     be attenuated by terazosin administration.~   "
118214|NCT01508624|"~     This research will evaluate the impact of interventions to improve pain relief and recovery~     following office based surgery.~      There will be three phases to this research. The first phase will focus on predicting~     recovery from office based vein surgery using a multiple regression analysis.~      Phase two will incorporate a randomised controlled trial to compare the effectiveness of a~     range of interventions in anxiety and pain reduction and recovery for office based vein~     surgery patients.~      The final phase of the investigation will utilise qualitative methodology to explore~     patients' experiences of each intervention and their opinions about what was and was not~     effective.~   "
118215|NCT01508611|"~     This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the~     treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent~     molars compared to a control group that performs only the cross-toothbrushing technique and~     evaluate the acceptability and satisfaction of patients and responsible for the application~     of the solution cariostatic.~   "
118216|NCT01508598|"~     Identification and validation of early chronic disease biomarkers in children is of~     paramount importance especially in the burgeoning arena of pediatric obesity research.~     Despite the presence of risk factors, few obese children develop overt cardiovascular~     disease (CVD) early in life. However, because CVD is a cumulative process occurring over~     time, identifying the earliest signs in order to intervene sooner may have a large impact on~     slowing its progression. Endothelial activation is one of the earliest detectable signs of~     the beginnings of CVD. However, accurately quantifying endothelial health in children has~     proven to be a major challenge. Direct measures of endothelial cell biology, such as~     circulating endothelial cells (CEC) and endothelial microparticles (EMP), have been~     extensively studied in adults and are associated with vascular diseases, CVD risk factors,~     and CVD events. Despite being well-validated in adults, CEC and EMP have not been formally~     evaluated as disease biomarkers in children and adolescents. Pediatric obesity is an ideal~     condition in which to validate CEC and EMP as disease biomarkers since adiposity in~     childhood is associated with CVD, type 2 diabetes mellitus, and premature death, later in~     life. The investigators primary focus in this study will be the evaluation of CEC and EMP as~     biomarkers of CVD risk and whether substantial changes in weight affect these biomarkers.~     The investigators propose to evaluate the change in levels of CEC and EMP in response to~     substantial weight loss in 32 adolescents with extreme obesity undergoing elective,~     clinically-indicated bariatric surgery.~   "
118217|NCT01508585|"~     Bariatric surgery is the most effective treatment for patients with extreme obesity.~     Psychological interventions are not routinely offered in Bariatric Surgery Programs.~     Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in~     reducing binge eating and improving surgical outcomes. The current study will examine~     whether the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more~     effective than the usual standard of care alone, and whether it is more effective when~     delivered prior to or following bariatric surgery.~   "
118218|NCT01508572|"~     The purpose of this study is to determine the uptake, (semi-)quantification and localization~     of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue,~     surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical~     specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using~     fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW~     is assessed. Another purpose is to assess the abilities of three different fluorescent~     signal detection systems to detect the fluorescent signal pre- and intra-operatively.~   "
118219|NCT01508559|"~     The treatment of HIV and the tests performed for HIV care have changed over the last 20~     years but improvement of management of HIV-infected subjects is still warranted. The~     investigators would like to collect and analyse clinical information obtained from subjects~     who are between 18 and 50 years of age. The investigators will look at routine clinic~     information such as blood pressure, recent blood test results and clinical history. The~     investigators will then assess cognitive (brain) function by talking and/or written tests.~     These tests will include tests for memory, depression and anxiety.~      All of those who are identified as having problems with their brain function in this way~     will be offered onward referral for further assessment as appropriate. Those taking part~     will be offered a follow up visit at 24-48 weeks after the first assessment to see if there~     are any changes. This will allow us to understand how brain problems develop, get worse, or~     get better over time. No genetic research will be done. Depression is a mental health~     condition that can be characterized by negative feelings, a generally low mood, or problems~     with eating and sleeping normally. Anxiety is also a mental health condition where a person~     can feel general anxiousness or fear of specific situations, or, in more serious cases, can~     have panic attacks. Impaired brain function is a condition of the nervous system or brain~     where the brain does not function as well as it normally should, and can include symptoms~     such as forgetfulness, doing everyday tasks more slowly or becoming disorientated to the~     time of day or the place one is in.~      For this study, the investigators will also collect data from medical records, including~     (and if known)social and educational-related data, HIV infection-related data (e.g. date of~     diagnosis, blood test results), relevant medical history (e.g. previous psychiatric~     conditions) and medication used (e.g. date started, the drugs used).~      The information the investigators will get from this study will be used to inform healthcare~     providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to~     routinely assess HIV infected patients for the presence of anxiety/depression and impaired~     brain function. The investigators will also get information on whether the treatments used~     for HIV infection make a difference to how commonly these conditions occur in patients.~   "
118220|NCT01508546|"~     Rationale~      Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant~     treatment planning.~      Purpose~      Randomized phase III trial to compare the effectiveness of surgical therapy with or without~     axillary dissection following conservative treatment in women with stage I breast cancer.~      To determine the possibility to avoid axillary surgery in patients with early breast cancer,~     finding an alternative method to define the need of adjuvant treatment without compromising~     long-term disease control.~   "
118221|NCT01508533|"~     This study was designed to support site preparation and to conduct a disease burden study~     for the planning and implementation of the phase III trials for the oral rotavirus vaccine~     116E.~   "
118222|NCT01508520|"~     Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and~     microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI~     for differential diagnosis among early gastric cancers (EGC) have not been fully~     established.The study is based on the hypothesis:~        1. ME-NBI is useful in distinguishing EGC from other gastric lesions~        2. ME-NBI is useful in further differential diagnosis among EGCs.~   "
118223|NCT01508507|"~     Various field studies has found that the modified , bivalent, whole cell - based oral~     cholera vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 %~     in earlier clinical trials. However, the effectiveness of the vaccine in real life~     situation using the public health system is unknown. It is critical to follow up in the same~     population, where pilot introduction of OCV was introduced and evaluate vaccine proactive~     effectiveness at individual as well as at population level. The follow - up and~     determination of effectiveness of mass OCV vaccination was requested by State Government.~   "
118234|NCT01508351|"~     Hypotension is a recognized frequent complication of induction of anesthesia. The intent of~     this research is to determine the incidence of hypotension in patients receiving anesthetic~     induction with propofol. This investigation seeks to examine how normal clinical practice or~     a real world understanding of the usual response to propofol affects hemodynamics without~     isolating or standardizing other variables. The current research concerns hypotension in~     normal clinical practice where variability exists. This project aims to gather information~     and data in an attempt to form a foundation upon which each of the other variables affecting~     blood pressure may be subsequently assessed.~   "
118252|NCT01508104|"~     The purpose of this clinical trial is to determine the effects good or bad of combining~     BEZ235 along with Everolimus to determine if it is a safe treatment for patients with~     advanced cancers of different types.~   "
118224|NCT01508494|"~     The investigators would like to conduct a double blind placebo-controlled prospective study~     to show the impact of a treatment combining a specific cognitive rehabilitation program and~     acetylcholinesterase inhibitors on executive function of young patients 3 months after a~     first symptomatic stroke. The secondary objectives will be to assess cognitive changes~     performance (executive but also non trained functions such as memory) before and after~     treatments and treatment effect on activity of daily living and on quality of life.~      The main objective of this study is to show the impact of this combined treatment on brain~     activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke.~     Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing~     a specific executive task.~      The investigators hypothesize that the specific rehabilitation associated with~     acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI,~     improve executive functions specifically, improve non trained cognitive functions~     (generalization effect).~   "
118225|NCT01508481|"~     Emerging evidence suggests that vitamin D [25-hydroxyvitamin D; 25(OH)D] may play a role in~     the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes~     and impaired glucose tolerance (IGT) compared with those with normal glucose tolerance~     (NGT). In addition, a few prospective studies have shown a significant inverse association~     of baseline serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms~     through which vitamin D affects diabetes risk are not yet fully known, particularly whether~     vitamin D plays a role in insulin resistance (IR) and/or b-cell dysfunction, the main~     pathophysiological disorders underlying type 2 diabetes. So, the investigators plan to~     examine the prospective associations of baseline vitamin D [25-hydroxyvitamin D; 25(OH)D]~     with insulin resistance (IR), b-cell function, and glucose homeostasis in subjects at risk~     for type 2 diabetes.~   "
118226|NCT01508468|"~     The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults.~     In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as~     idiopathic membranous nephropathy (IMN).The most of these patients are treated by non~     immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive~     blocking the rennin-angiotensine system. However, the patients resistant to antiproteinuric~     treatment risk to develop an end stage renal disease (ESRD).~      Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN~     in four international studies. Rituximab appears effective and safe in reducing proteinuria~     in nearly 60% of patients.~      The primary outcome of the investigators prospective randomized study is to determine~     whether or not the Rituximab associated with NIST is more effective than non immunologic~     symptomatic treatment alone in inducing long term remission of proteinuria.~   "
118227|NCT01508455|"~     The primary objective of this study is to characterize the safety, and efficacy of~     Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a~     continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational~     age.~   "
118228|NCT01508429|"~     Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a~     low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH),~     especially in settings where injectable uterotonics are not yet available or feasible to~     use.~      A double-blinded individual randomized controlled study of misoprostol versus placebo in~     home deliveries in four districts in the Badakshan Province in Afghanistan. The study will~     recruit pregnant women who are likely to deliver at home. All women enrolled in the study~     will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after~     delivery of their baby (ies) and before delivery of the placenta.~      Women who experience a PPH will be randomized to receive either: a) standard of care + 800~     mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets~     resembling misoprostol. In this setting, standard of care is referral.~   "
118229|NCT01508416|"~     Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event,~     especially in newly diagnosed patients and during induction treatment with thalidomide in~     combination with dexamethasone. This association was mainly heightened during the 3 first~     months of chemotherapy.~      Several coagulation abnormalities have been described. Laboratory tests measuring the~     overall thrombophilic tendency might be useful to assess thrombosis risk.~      The aim of this study is to compare thrombin generation by calibrated automated thrombogram~     during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.~   "
118230|NCT01508403|"~     The purpose of this study is to make a cohort event monitoring to see whether and how~     Shuxuetong injection in hospital results in adverse events or adverse drug reactions.~   "
118231|NCT01508390|"~     In this study, participants will have standard ADT and undergo standard XRT to the prostate~     and at-risk lymph nodes by IMRT. The subsequent *boost* RT to the prostate alone will be~     given using the CyberKnife, rather than using the standard IMRT. This study will also see~     how CyberKnife affects the quality of the participant's life.~   "
118232|NCT01508377|"~     For several years now, a very successful treatment of posttraumatic stress disorders has~     been offered in the Netherlands and in Germany. The contact between clients and therapists~     takes place exclusively via Internet. The therapists follow a scientifically tested~     treatment protocol, that defines fixed treatment elements that are adapted to the specific~     situation of the client. The participants can write at home, in their familiar environment~     which makes it easier to work on trauma related issues with their therapist. In the last~     years the treatment was offered in Arabic as well indicating to be an effective treatment~     for Posttraumatic Stress Disorder (PTSD) in Arabic-speaking countries.~      The treatment lasts five weeks. During that time-frame, participants write several texts.~     The participants decide when they want to write. Each time after having received two texts,~     the therapists provide feedback and further instructions. The therapists are all trained~     psychologists, who have received additional training in the interpretation of texts and for~     the application of the treatment protocol.~      The investigators hypothesize that both interventions will significantly improve clinical~     symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes~     such as anxiety, depression and quality of life.~   "
118233|NCT01508364|"~     This is an observational study which will investigate the use of Nexavar as first targeted~     therapy in patients with advanced renal cell carcinoma.~   "
118235|NCT01508338|"~     The purpose of this study is to~        -  determine the effects of 12 weeks of HMB free acid gel, ATP, and HMB free acid gel plus~          ATP supplementation in trained individuals during a periodized training program on~          skeletal muscle hypertrophy, body composition, strength, force, velocity, and peak~          power during loaded and unloaded vertical jumps.~      Additionally, the study will determine if either supplementation protocol prevents the~     typical decay seen in performance following an overreaching cycle performed in the 9th and~     10th weeks of the study.~      Finally, the study will elucidate the mechanisms of action of supplementation on protein~     breakdown by analyzing serum indices of muscle damage (CK, LDH) and anabolic status~     (Testosterone:Cortisol ratio) as well as a urinary indicator of protein breakdown~     (3-methylhistidine).~      We hypothesize that under these conditions that the supplementation protocols will augment~     skeletal muscle hypertrophy, strength, and power and that HMB will blunt increases in serum~     indices of muscle damage, and urinary indices of protein breakdown.~   "
118236|NCT01508325|"~     This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority~     and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet~     in subjects with mild to moderate primary hypertension.~   "
118237|NCT01508312|"~     The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE~     prior to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2~     steps to treating patients with relapsed or refractory HL. The first step is to shrink the~     lymphoma with chemotherapy. The chemotherapy regimen commonly used is called ICE. ICE is a~     combination of chemotherapy drugs: ifosfamide, carboplatin, and etoposide. The second step~     of treatment is to give high doses of chemotherapy and radiation therapy followed by~     infusion of stem cells. This is called an ASCT. This study will focus on the first step of~     treatment for relapsed and refractory HL.~      ICE chemotherapy can cause many side effects. We believe that there are patients who can~     receive less toxic treatments and still do well. We have learned from past studies that~     [18F]FDG-PET scans (which we will call PET scans) can be used to predict who will do well~     after ASCT. PET scans are tests used to measure the metabolic activity of the disease.~     Patients without abnormal activity on their PET scan (negative PET scan) before ASCT are~     much more likely to be cured than those with activity on their PET scan (positive PET scan).~      In this study, instead of beginning with ICE chemotherapy, the patient will receive a new~     drug called Brentuximab vedotin (SGN-35). SGN-35 is a type of drug called an antibody drug~     conjugate. SGN-35 has 2 parts; a part that targets cancer cells (the antibody) and a cell~     killing part (the chemotherapy). The antibody part of SGN-35 sticks to a target called CD30.~     CD30 is an important molecule on some cancer cells (including Hodgkin lymphoma) and some~     normal cells of the immune system. The cell killing part of SGN-35 is a chemotherapy called~     monomethyl auristatin E (MMAE).~      It can kill cells that the antibody part of SGN-35 sticks to.~      Compared to ICE chemotherapy, SGN-has fewer side effects and does not require inpatient~     admission for treatment. We aim to determine whether patients can avoid treatment with ICE~     prior to ASCT. We will use the results of the PET scan to determine whether the patient~     needs additional chemotherapy before ASCT. If the PET scan is negative, the patient will be~     referred to ASCT and not receive ICE chemotherapy. If the PET scan is positive, the~     physician will discuss further treatment options with the patient.~   "
118238|NCT01508299|"~     Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by~     skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal~     and reproduce false negative results (no allergy) in patients with history highly suggestive~     of allergic reaction. The aim of this study is to compare the reproducibility of different~     commercial extracts and raw food in patients with convincing history of acute allergic~     symptoms related to food .~   "
118239|NCT01508286|"~     The purpose of this early access program is to provide telaprevir to patients with a~     specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to~     benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not~     yet commercially available and who are not eligible for enrollment into a clinical study of~     telaprevir. The study also aims to collect information on the safety and adverse events with~     telaprevir treatment in combination with peginterferon alfa and ribavirin, which is~     typically used to treat patients with hepatitis C. In addition to hepatitis C viral~     infection, patients in this study will also have a diagnosis of liver fibrosis and~     compensated liver disease.~   "
118240|NCT01508273|"~     The goal of this behavioral research study is to find out more about the health behaviors of~     cancer survivors. Researchers want to understand the cultural, social, and environmental~     factors related to physical activity and personal diet. Researchers also want to learn if~     cancer survivors who take part in lifestyle interventions have better overall health and~     quality of life than those who do not take part in these interventions.~   "
118241|NCT01508260|"~     The goal of this clinical research study is to learn about the safety and level of~     effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to~     help the kidneys to form more urine. They also remove fluids from patients with severe fluid~     overload who have not responded to diuretics.~      Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too~     much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and~     passed through a special filter. The filter separates the excess salt and water from the~     blood. The blood is returned to the patient and the fluid is collected in a bag to be~     disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.~   "
118242|NCT01508247|"~     Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause~     of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae~     in a small proportion of cases. There has been a significant increase in EV71 epidemic~     activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region~     have heen associated with a severe from of brainstem encephalitis associated with pulmonary~     oedema and high case-fatality rates.~      The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a~     clinically acceptable safety and good immunogenicity for healthy Chinese children and~     infants. According to the immunogenicity and safety results, the 320U with adjuvant with~     immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.~   "
118243|NCT01508221|"~     The purpose of this study is to determine whether the use of Trental and Vitamin E can help~     reduce the incidence of radiation necrosis (a lesion that usually occurs at the original~     tumor site) after radiosurgery. These two drugs are commonly used to treat radiation~     necrosis when it occurs but the hope is that these drugs can be used to prevent radiation~     necrosis from ever occurring.~   "
118244|NCT01508208|"~     The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and~     evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of~     urine for proteinuria is the gold standard for the diagnosis of the condition and allows the~     physician to determine if an hypertensive disorder is related directly or not to the~     gestation.~      The problem is the time it takes and the technical difficulties related to the sample~     collection. An alternative is the quantification of protein and creatinine in a random~     sample of urine. We seek to evaluate if this method is as affective as the gold standard in~     the diagnosis of proteinuria (>300 mg/d).~   "
118253|NCT01508091|"~     Calorie restriction is the only experimental manipulation that prolongs longevity in~     experimental animals. The life prolonging effects of calorie restriction are related to a~     lower incidence of tumors and less inflammation, but more importantly, a lower generation of~     reactive oxygen species (ROS). This effect is related to the overexpression of two groups of~     enzymes. One is a group of (NAD+)‐dependent deacetylases called sirtuins whose main actions~     are to increase free fatty acid flow from adipose tissue, improve insulin secretion and~     promote mitochondrial biogenesis in muscle. The other group corresponds to uncoupling~     proteins (UCP), specially UCP 3 that reduces the mitochondrial production of ROS. On the~     other hand, an effect of calorie restriction that is always reported, is a decrease in~     resting energy expenditure. A reduction in the activity of UCP1 in brown adipose tissue~     could be a mechanisms to explain this effect. However sirtuins apparently increase the~     expression of UCP1.Recently PET CT scans have emerged as a non invasive methodology to~     recognize brown adipose tissue activity and indirectly, UCP1 activity. Also measurement of~     telomere length in peripheral blood mononuclear cells has consolidated as a good marker of~     aging. Two possible models of calorie restriction can be studied in humans. One is a~     retrospective model in which adults are separated in those that have maintained a stable~     weight during adulthood in a manner analogous to the weight clamp model of calorie~     restriction in non human primates. This model is only reliable if there are objective~     records of the weight that the studied subjects had 20 or more years ago. In the~     retrospective part of this project the investigators propose to study adults whose weight~     was recorded previously. The investigators pretend to compare telomere length and expression~     of SIRT1 and 6 in PBMC, plasma 8 isoprostanes and carotid intima media thickness between~     weight maintainers and weight gainers. The investigators hypothesis is that weight~     maintainers will have a better aging profile than weight gainers. In the prospective part of~     the project the investigators will study a human model of calorie restriction prescribing a~     25% reduction in calorie intake during 3 months and comparing groups according to weight~     loss. At baseline and the end of the study period, UCP3 and SIRT1 expression in muscle~     biopsies, SIRT1 and 6 expression in PBMC and brown adipose activity, assessed by~     18fluorodeoxyglucose uptake using PET/CT will measured. The investigators hypothesis is that~     individuals subjected to calorie restriction will experience an increase in the expression~     of UCP3, SIRT1 and SIRT6 and a reduction in brown adipose tissue activity. Simultaneously,~     these subjects will experience a reduction in oxidative stress markers in muscle and plasma.~   "
118254|NCT01508078|"~     This study is designed to characterize subjects in terms of the nature and severity of their~     asthma and in terms of conditions that may alter the clinical expression of asthma. Some~     features will be obtained in all subjects. These include a medical history and baseline lung~     function tests. This characterization forms the basis for our database that facilitates~     research protocols.~   "
118255|NCT01508065|"~     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic~     goal that is difficult to achieve with current blood glucose monitoring technology. Home~     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of~     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and~     easy to operate glucose monitoring in DM patients for strict glycemic control cannot be~     overemphasized.~      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an~     acceptable mean relative error when compared to acceptable invasive blood glucose~     measurements.~      The primary objectives of the trial are to determine:~        1. The safety of the Glucometer GM-205 in evaluating blood glucose levels~        2. The accuracy of the Glucometer GM-205 in evaluating blood glucose levels~   "
118256|NCT01508052|"~     We hypothesized that sequential compression device (SCD) compression system might induce~     more decreases on core temperature by increasing lower extremity blood flow. And, this study~     investigated the effects of SCD compression system on body temperature in patients during~     total intravenous anesthesia (TIVA) with propofol and remifentanil.~   "
118257|NCT01508039|"~     The purpose of the study is:~        -  To investigate whether chitin can effect healthy adults, the nasal mucosa in a~          direction that will enhance the immune response to infection~        -  To investigate whether chitin influence of the nasal mucosa is well tolerated, and that~          there is no inflammation, as it seen with exposure to endotoxin.~   "
118258|NCT01508026|"~     To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan~     compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.~   "
118259|NCT01508013|"~     The purpose of this study is to determine whether a skin cancer prevention website is~     effective at reduce female teenagers' desire to use indoor tanning and ultimately their use~     of indoor tanning over an 18 month period.~   "
118260|NCT01508000|"~     Patients presenting with multiple innumerable liver metastases will probably never come to~     resection, however, for all others, including patients with numerous multiple metastases or~     large metastases,resection should be considered after limited chemotherapy.~      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.~     FOLFOX was used in the previous EORTC study and is again recommended.~      The addition of targeted agents to standard chemotherapy in the perioperative strategy for~     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,~     therefore translating to a better outcome.~      It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase~     II study.~      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery~     Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery~   "
118261|NCT01507987|"~     The objectives of the study are:~        1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush,~          kink, broken filars on a shocking coil and other irregularities) by each subcategory at~          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        4. To determine the incidence of externalized conductors after enrollment in Riata®,~          Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        5. To determine the incidence of other visual lead anomalies by each subcategory after~          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads~        6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata®~          ST Silicone, QuickSite®/QuickFlex® and Durata® leads.~        7. To evaluate the 30-day adverse event rate associated with lead revision procedures~          (include lead extractions or abandonments with or without lead replacement) in Riata®,~          Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads~        8. To determine the prevalence of other insulation anomalies in returned leads for~          Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads.~          Other insulation anomalies include any of the following:~             -  Internal abrasion short under RV shock coil~             -  Internal abrasion short under SVC shock coil~             -  Exposed conductors defined as a breach of the outer insulation~             -  Breach of the internal silicone lumen tubing, but the conductor cable is contained~               within the lead body diameter.~   "
118262|NCT01507974|"~     Urinary tract infection is the most common bacterial infection during pregnancy.~     Asymptomatic bacteriuria is the most common infection, in up to 8% of the population.~     Symptomatic infection may cause cystitis or cause pyelonephritis.~      Among pregnant women with recurrent bacteriuria, preventive antibiotic treatment has been~     found to be efficacious in reducing the bacteriuria rate and the complications.~      the changes of the urinary tract which appear during pregnancy usually resolve up to 3~     months post-partum.~      The purpose of this study is to examine the efficacy of preventive antibiotic treatment~     during the puerperium.~   "
118263|NCT01507961|"~     Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and~     clinical measurements.~   "
118305|NCT01507415|"~     This study aims to evaluate simple tests of physical function in hospitalised patients with~     chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future~     hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of~     standing balance, usual walking speed (4-metre gait speed) and ability to stand from a~     chair, which reflects global physical functioning and frailty.~      We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.~   "
118264|NCT01507948|"~     The investigators are seeking people who have been exposed to a traumatic event in the past~     and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may~     feel significant distress when reminded of a traumatic event or feel depressed, anxious or~     jumpy.~      As a part of this study, participants will receive brain MRIs and office assessments before~     and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD,~     Prolonged Exposure, free of charge; additionally participants are compensated for their~     time during assessment procedures. This study is exploring the brain circuitry involved in~     improvement in response to psychotherapy.~   "
118265|NCT01507935|"~     This study is initiated to investigate the effect of infant formulas with added specific~     prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.~   "
118266|NCT01507922|"~     It is a randomized double-blind parallel phase IV study to compare Fenoverine and~     Trimebutine maleate in the efficacy and safety.~      Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and~     safety.~   "
118267|NCT01507909|"~     Exposure to alcohol related cues, such as the sight of alcoholic drinks, may induce craving~     for alcohol in drinkers. In this study, the effects of exposure to (1) the pictures of~     alcoholic drinks and (2) the imagining of a scene related to drinking on activity in the~     frontal region of the brain in heavy social drinkers will be determined. This study is being~     conducted to develop the methods needed to allow for the detection of cue-induced changes in~     drinkers using the EEG. The objective of this pilot study is to establish procedures for~     detecting alcohol-related cue-elicited changes in EEG activity in heavy drinkers.~   "
118268|NCT01507896|"~     The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in~     subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B~     undergoing major or minor elective or emergency surgical, dental or other invasive~     procedures.~   "
118269|NCT01507883|"~     Current human IVF technology employs two strategies with respective culture media for embryo~     development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature'~     (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to~     evaluate potential advantages/disadvantages of these strategies on one another.~   "
118270|NCT01507870|"~     Incisional hernia is one ot the most frequently seen long term complications in abdominal~     surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for~     incisional hernia after midline incision remains about 5-20 %. One major risk factor for~     incisional hernia after a median laparotomy is obesity.~      The closure technique of midline incisions has remained unchanged since many decades and~     primarily consists of suturing the linea alba. Interest in prevention of incisional hernias~     with the aid of synthetic mesh is growing and only one large randomized trial is active~     recruiting patients in Germany, Netherlands and Belgium (Prima Trial).~      Patients with a BMI of more than 27 have a high risk of developing an incisional hernia~     after midline incision with an incidence of 22% after 12 months. This high risk group of~     patients may benefit from prevention.~      Some small studies have been performed to evaluate the usefulness and safety of primary~     laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk~     for incisional hernias and a low infection rate, even when used in contaminated wounds such~     as colostomy surgery.~      The goal of this study is to evaluate the effectiveness of incisional hernia prevention~     after elective median laparotomy in patients with a BMI of more than 27. A randomized~     controlled trial will be performed comparing the commonly used technique of running suture~     to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be~     incisional hernia occurrence. Secondary outcome measures will be complications, surgical~     site infections, post-operative pain and quality of life.~   "
118271|NCT01507857|"~     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71~     Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy~     infants volunteers aged from 6 to 35months old.~   "
118272|NCT01507844|"~     Chronic obstructive pulmonary disease is a disease characterized by small airways~     inflammation and obstruction. The small airways disease produces hyperinflation (air~     trapping), which increases with exercise. Continuous positive airways pressure may reduce~     small airways obstruction and therefore air trapping. Pulmonary function tests including~     lung volumes at rest and and after exercise will be measured. In addition, exercise~     endurance time before treatment and after treatment will be measured.~   "
118273|NCT01507831|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9~     (proprotein convertase subtilisin/kexin type 9).~      Primary Objective of the study:~      To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk~     participants with hypercholesterolemia not adequately controlled with their current lipid~     modifying therapy (LMT).~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)~          levels after 24 weeks of treatment in comparison with placebo.~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time~          points.~        -  To evaluate the effects of alirocumab on other lipid parameters.~   "
118274|NCT01507818|"~     To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on~     narcotic use, pain, and health-related quality of life following shoulder arthroscopic~     rotator cuff surgery comparing: Active treatment versus placebo (Sham).~   "
118275|NCT01507805|"~     The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning~     for five days before operation can improve the outcomes of patients with coronary heart~     disease undergoing geriatric non-cardiac surgery.~   "
118276|NCT01507792|"~     Chronic cough is more frequent and severe in women than in men. Women often have decreased~     iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron~     deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled~     irritants.~   "
118277|NCT01507779|"~     The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent~     A/H1N1 influenza vaccine (IVACFLU)-—each dose with an HA content of 15 mcg from~     A/California/07/2009 (H1N1)-like virus-—will be safe and immunogenic in healthy adults.~   "
118306|NCT01507402|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study to~     assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC)~     REGN1033(SAR391786) in healthy volunteers.~   "
118278|NCT01507766|"~     As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN),~     especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and~     stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents~     bacterial and endotoxin translocation and thereby theoretically reduces the incidence of~     infections. Therefore, EEN has the ability to reduce the infectious complications, length of~     hospital stay and mortality of patients with SAP.~      However, the role of EEN is considered to be influenced by intra-abdominal hypertension~     (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive~     splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it~     reduces the blood flow of gut, and then results in the development of intestinal ischemia~     and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability~     of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH~     could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of~     specific IAP values on the tolerance of EEN have not been reported.~      Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due~     to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause~     expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up~     to date reporting the association between EEN and IAH in patients with SAP. Therefore, the~     present study aimed to investigate the influence of specific IAP on the tolerance of early~     enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts~     of EEN on the disease severity and clinical outcome of SAP were also researched.~   "
118279|NCT01507753|"~     Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be~     a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly~     impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available~     evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are,~     unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005;~     2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a~     beneficial effect on mood, which might provide either a primary or adjunctive treatment with~     a more favorable risk:benefit ratio for children suffering from BP-NOS than currently~     available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown~     promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006;~     Fristad, Verducci, Walters, & Young, 2009); its efficacy in treating BP-NOS specifically has~     not been determined.~      The current study compares Ω3, PEP, and their combination to a placebo supplement and active~     monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP,~     PEP, and placebo, all with active monitoring). Primary goals are to determine: 1)~     feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a~     12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment~     on manic and depressive symptoms. Secondary goals are to explore response curves over time,~     mediators and moderators, treatment response across a broad array of outcome variables,~     adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing~     medications, and experience of side-effects in participants receiving Ω3 and/or PEP.~     Comparisons of results to a parallel study of children with depression with identical design~     will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will~     provide evidence about whether a larger trial is feasible and justified.~   "
118280|NCT01507740|"~     Tumour angiogenesis has been identified to play a critical role in tumour growth and this~     knowledge has led to the identification of new targets for cancer therapy. Multiple~     angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular~     endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF~     signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been~     successfully established for the treatment of different cancer entities and multiple new~     drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents~     being available in the near future will raise the questions when to use which agent and in~     which sequence. As a consequence biomarkers are going to be indispensible tools for choosing~     the most effective drugs and to predict dosing and resistance.~      The present project is based on an academic clinical trial in which patients suffering from~     different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and~     hepatocellular cancer) treated routinely with antiangiogenic agents will be included.~     Consecutive serum and blood probes will be taken and will be examined and correlated with~     functional imaging and the clinical course. The following parameters have been selected:~     soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and~     cellular parameters like circulating endothelial cells (CEC) and circulating endothelial~     progenitor cells (CEPs).~      In conclusion, the present project is screening for potential biomarkers and biomarker~     combinations relevant for antiangiogenic drugs in different tumour types. The predictive~     value of such profiles should then be evaluated in larger cohorts. In the future such~     profiles could possibly help clinicians to use these agents more effectively and therefore~     also more economically.~   "
118281|NCT01507727|"~     This drug has been developed to treat Hyponatremia. The primary purpose of this study is to~     verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15,~     30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary~     to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate~     Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being~     conducted in China.~   "
118282|NCT01507714|"~     Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress~     incontinence is a health problem with social, economic and psychological consequences. The~     appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known~     phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which~     has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence~     post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress~     incontinence.~      The aim of this study is to examine the efficacy of transobturator tension free vaginal tape~     (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.~   "
118283|NCT01507701|"~     The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and~     safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the~     investigators wanted to assess appropriate dosage in relation to a) plasma concentration~     levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure~     responses when rising up), and c) reports of possible adverse effects.~      A possible beneficial effect of clonidine in adolescent CFS will be investigated in~     NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.~   "
118290|NCT01507610|"~     The purpose of this study is:~        -  To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg~          OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX®~          (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in~          healthy subjects.~        -  To estimate the relative bioavailability of single-dose intranasal administration of 20~          mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX®~          (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan)~          Subcutaneous Injection, in healthy subjects.~   "
118284|NCT01507688|"~     The experience of a stroke event may result in a disruption to the survivor's daily life.~     Patients with stroke have reported fears of permanent disability and major concerns over~     their ability to recover and be productive and engaged with family, friends and coworkers.~     To enhance recovery from stroke, the investigators designed a stroke self-management program~     and have pilot tested the program among Veterans recovering from stroke/TIA. The proposed~     study is a three-site, randomized controlled trial designed to test the efficacy of a stroke~     self-management program. The intervention program includes 6 bi-weekly sessions over months~     1-3 followed by monthly telephone calls as the investigators administered in the~     investigators' pilot study during months 4-6 for a total length of program duration of 6~     months. The investigators have added 3 monthly group support sessions during months 4-6 for~     additional peer support. Thus, participants will receive bi-monthly support during months~     4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush~     VAMC in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The~     three hospitals represent facilities with a small, moderate, and large volume of acute~     stroke care, respectively. Additionally, Methodist Hospital includes a greater proportion of~     women which enables us to study the patterns and preferences of women with stroke/TIA and~     tailor the investigators' future programs to prepare for the increasing female Veteran~     population.~   "
118285|NCT01507675|"~     The primary purpose of the current study is to rigorously test the psychometric properties~     of the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been~     done to date. Factor structure, internal consistency, convergent and discriminant validity~     will all be assessed. Secondary goals are to determine if burdensomeness, failed~     belongingness, and acquired capability are distinct versus overlapping constructs and~     whether or not values mediate the relationship between reasons for living and suicide risk.~     Lastly, the inclusion of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze~     participants' responses to explore whether or not participants can be grouped into those who~     want to die by suicide because they want to escape their problems and those who want to die~     to influence other people.~   "
118286|NCT01507662|"~     There is growing evidence that patients undergoing bone mineral density testing (BMD) often~     do not take important steps to improve their bone health. The investigators will conduct a~     randomized-controlled trial to evaluate the impact of a novel and practical patient~     activation intervention (mailing patients their bone density test results) on the quality of~     bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the~     investigators intervention could easily be modified to include other patient populations and~     chronic diseases.~   "
118287|NCT01507649|"~     Purpose: To evaluate the effectiveness of a telephone-based intervention using~     cognitive-behavioral approach in preventing postnatal depression and improving quality of~     life in first-time Chinese mothers.~      Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will~     have a lower level of depressive symptoms (primary outcome) and a higher level of quality of~     life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care.~      Design and subjects: Randomized controlled trial is used. A sample of postpartum women with~     high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either~     the experimental (n = 249) or the control groups (n = 249). The experimental group receives~     the intervention and the control group receives usual postpartum care.~      Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12).~      Interventions: The intervention is based on the cognitive-behavioral approach. It consists~     of five, 30-minutes sessions delivered weekly from postpartum week one to week five via~     telephone.~      Main outcome measures and analysis: Outcomes on postnatal depression and quality of life~     will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A~     repeated-measures multivariate analysis of variance will be used to compare differences~     between two groups.~   "
118288|NCT01507636|"~     Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb~     movements, which cannot be explained by elementary motor and sensory deficits or cognitive~     problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous~     system and the leading cause of disability in young adults. Apraxia and impaired manual~     dexterity are common problems in patients with MS leading to impaired activities of daily~     living. However, a specific training program to improve apraxia as well as manual dexterity~     in MS is lacking.~      In this study, the investigators want to evaluate the impact of a targeted occupational~     therapy program on apraxia and manual dexterity in patients with MS that have dexterity~     problems.~      Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion~     and exclusion criteria and willing to participate in the study will be evaluated for Apraxia~     and manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be~     randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental~     group) or general physical exercises (control group) for 4 weeks.~      At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in~     all patients.~   "
118289|NCT01507623|"~     Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia.~     During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during~     endoscopy have been introduced. The method has been implemented at the endoscopic unit at~     Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may~     result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half~     life this is prevented in the majority of cases. However, in spite of this, hypoxia is~     experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital~     (unpublished data). It is well known that hypoxia constitutes a late expression of reduced~     oxygen tension in peripheral tissues. Whether the addition of capnography to standard~     monitoring during NAPS may be of benefit is widely unknown. The aim of this study is to~     examine whether the additional use of capnography to standard monitoring during endoscopy~     may improve patient safety in patients undergoing low dose Propofol sedation by reducing the~     number, duration and level of hypoxic events. The trial is a randomized clinical prospective~     case-control study.~   "
118307|NCT01507389|"~     This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in~     subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects~     with normal hepatic function.~   "
118308|NCT01507376|"~     This study is a prospective randomized clinical trial to compare the efficacy of the urinary~     and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.~   "
118291|NCT01507597|"~     Diabetes(both types) are recognized by high levels of glucagon in the circulation.~      Glucagon is known to increase blood glucose, and might therefore contribute to the~     respective diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon~     secretion.~      The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at~     increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and~     in patients with type 1 diabetes.~      The investigators think that the effect of GLP-1 on the glucagon secretion might be~     dependent of blood glucose levels.~   "
118292|NCT01507584|"~     This clinical trial is designed to investigate the efficacy profile of the SENSIMED~     Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension,~     done three times at monthly intervals under different therapeutic regimen. This trial will~     also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular~     pressure (IOP) after the water drinking test (WDT) will be investigated.~   "
118293|NCT01507571|"~     The purpose of the study is to investigate whether Danish patients with incurable cancer~     have a need of, interest in and benefit from Dignity Therapy.~   "
118294|NCT01507558|"~     The purpose of this study is to test if dexamethasone, an anti-inflammatory medication~     approved by the US Food and Drug Administration (FDA), can be injected safely into the~     tissue around the blood vessel wall at the time of an angioplasty or atherectomy.~   "
118295|NCT01507545|"~     The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and~     safe in the treatment of metastatic, colorectal cancer.~   "
118296|NCT01507532|"~     Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of~     Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of~     intravenous ceftazidime pharmacokinetics will be performed in patients undergoing~     intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of~     ceftazidime in high flux hemodialysis.~   "
118297|NCT01507519|"~     1.) Indigenously developed and designed BioMimeTM is a~        -  predictably safe & efficacious 3rd generation drug eluting stent (DES)~        -  with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low~          strut thickness Co-Cr stent,~        -  highly documented drug Sirolimus &~        -  a biocompatible, biodegradable polymer~   "
118298|NCT01507506|"~     This is a multi-institutional phase III clinical study of interventional type. The trial~     will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3~     years of follow up.~      Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or~     surgical specimen) and who meet all eligibility criteria will be randomized in one~     chemoradiotherapy arm :~        -  Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide~        -  Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy~          guided by magnetic resonance spectroscopic imaging + Temozolomide The patient~          monitoring will be regular and standardized. The main objective of this study is to~          improve overall survival of patients treated in experimental group (with simultaneous~          integrated boost).~   "
118299|NCT01507493|"~     This study was conducted to explore whether the non-synonymous single-nucleotide~     polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative~     pain intensity in the general population undergoing upper abdominal surgery. Methods:~     Patients receiving elective upper abdominal surgery under general anesthesia were recruited~     into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators~     measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO).~     The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled~     analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press~     frequency and drug consumption were recorded.~   "
118300|NCT01507480|"~     Antiangiogenic drugs, such as bevacizumab, are a new treatment strategy in Hereditary~     Hemorrhagic Telangiectasia (HHT). Its systemic administration in patients with HHT improves~     liver damage-related symptoms and epistaxis (cases reported and on-going~     study-ClinicalTrials.gov Identifier #NCT00843440-). To limit the systemic adverse effects of~     bevacizumab and to ease administration, a local administration seems suitable.~      A clinical case recently showed the benefits of bevacizumab nasal spray in these patients.~     Its results were confirmed in a characterization study on bevacizumab transport through~     porcine nasal mucosa (in press).~      It seems necessary to assess the tolerance and efficacy of bevacizumab nasal spray in humans~     for the treatment of epistaxis in HHT with a prospective phase 1 study.~      The primary objective of the study is to evaluate the tolerance of increasing doses of~     bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.~      This phase-1, randomized, double-blind, placebo-controlled, monocentric study is to be~     carried out sequentially (dose escalation) on 5 groups of 8 patients. Each group is made up~     of 6 verum and 2 placebos.~   "
118301|NCT01507467|"~     The purpose of this study is to test the hypothesis that radiotherapy of head and neck~     carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a~     hypoxic radiosensitizer in association with accelerated fractionation, in an unselected~     patient population in a global environment.~   "
118302|NCT01507454|"~     This study is conducted in Europe. The aim of this study is to investigate the self-reported~     impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic~     vaginitis due to oestrogen deficiency.~   "
118303|NCT01507441|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies DNA samples from patients with Down syndrome and acute~     myeloid leukemia treated on COG-AAML0431 clinical trial.~   "
118304|NCT01507428|"~     This randomized phase II trial studies how well positron emission tomography (PET)/computed~     tomography (CT)-guided radiation therapy works compared to standard radiation therapy in~     treating patients with stage III non-small cell lung cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans,~     to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor~     and cause less damage to healthy tissue.~   "
118309|NCT01507363|"~     Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The~     investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.~   "
118310|NCT01507350|"~     Increasing risk of impaired renal function as a result of obesity is well known. Early data~     has postulated that weight loss might improve kidney function, but the evidence is rather~     limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight~     loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in~     Renal Disease (MDRD) equations, have all yield conflicting results after weight loss~     surgery.~      The study aim to assess:~        1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in~          renal function before and after weight loss surgery.~        2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss~          surgery~        3. the differences in alterations in renal function dependent on the surgical procedures(~          gastric bypass, gastric band, sleeve gastrectomy).~        4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.~   "
118311|NCT01507337|"~     This trial is conducted in Europe. The aim of this trial is to compare the exposure of~     liraglutide in young versus elderly healthy subjects.~   "
118312|NCT01507311|"~     This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC~     90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard~     meal in subjects with type 2 diabetes.~   "
118313|NCT01507298|"~     This is an observational study, which aims to compare the outcomes of ambulatory~     gastrointestinal investigations with physical activity using accelerometry. An ambulatory~     study refers to one in which the patient is monitored freely, often outside of the hospital~     environment. For this the investigators will use a lightweight (7.4g) tri-axial~     accelerometer worn behind the ear.~      For capsule endoscopy, the investigators are interested in how physical activity affects the~     speed of capsule transit through the GI tract. Capsule endoscopy involves a patient~     swallowing a pill which contains a camera, in order to image the parts of the bowel that a~     conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal~     visualisation, which would reduce the sensitivity of the investigation.~      For oesophageal pH monitoring, it is essential that the patient behaves as they would~     normally to produce measurements that represent a standard day. Using accelerometry, the~     investigators can compare the amount, and nature, of physical activity taken throughout the~     investigation to that of the preceding day, or week. In addition, further analysis of motion~     data captured will allow us to correlate specific activities and body orientation with pH~     readings to get a better insight into the pathophysiology of a patient's condition.~      The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient~     service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will~     be asked to consider participating. Patients will receive the eAR sensor up to 2 days before~     their investigation, and will be asked to wear it until the end of their investigation (not~     whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring~     takes between 24 and 48 hours. Participation makes no difference to the standard or type of~     care that they will receive, the sensor data is additional.~      Hypothesis 1 There is no change in the amount or nature of physical activity taken by~     patients during ambulatory oesophageal pH monitoring or capsule endoscopy.~      Hypothesis 2 There is no correlation between physical activity levels and speed of~     gastrointestinal transit.~   "
118314|NCT01507285|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety and~     tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170~     (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.~   "
118315|NCT01507272|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety and~     tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170~     (liraglutide).~   "
118316|NCT01507259|"~     The popularity of chocolate can largely be attributed to its mood elevating properties,~     research shows that it contains antioxidants that also provide physical health benefits.~     Dark chocolate, in particular, contains high levels of an antioxidant called epicatechin,~     which is known to cause changes in blood vessels by relaxing them and increasing blood flow.~      Little is know about the immediate effects of chocolate consumption, or the differences~     between milk and dark chocolate with regards to these effects. The project will investigate~     the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using~     simple ultrasound tests.~   "
118317|NCT01507246|"~     This study is designed to compare the standard of care against EXPAREL(R) to determine if~     total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total~     hospitalization costs.~   "
118318|NCT01507233|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     extended-release injectable suspension) to determine if total opioid consumption is reduced~     when using EXPAREL, therefore possibly reducing total hospitalization costs.~   "
118319|NCT01507220|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     extended-release injectable suspension) to determine if total opioid consumption is reduced~     when using EXPAREL therefore possibly reducing total hospitalization costs.~   "
118320|NCT01507207|"~     Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging~     science. The largest published series of pediatric patients with type I laryngeal clefts~     shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of~     treatment. A comparison of quality of life outcomes before and after injection laryngoplasty~     has not been carried out. The investigators hypothesize that injection laryngoplasty~     significantly improves symptoms and quality of life related to dysphagia in a pediatric~     population with laryngeal clefts.~   "
118321|NCT01507194|"~     This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV~     ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure~     of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.~   "
118322|NCT01507181|"~     This study will examine the effects of Intravenous (IV) ketamine both in an outpatient~     population and with subjects on the inpatient unit with suicidal ideation (SI).~   "
118323|NCT01507168|"~     This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety~     of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic~     hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3~     expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or~     placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs.~   "
118324|NCT01507155|"~     Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which~     clinicians can administer to patients using a simple saliva sample technique. The present~     study proposes to enroll 1. Subjects (patients who have consented to using the Genecept~     Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf~     of their patients). This study will involve the collection of responses from both Subjects~     and clinician study participants with the intention of correlating this information to~     Subject genetic data.~   "
118325|NCT01507142|"~     This study has been designed to evaluate a new oral test for therapeutic monitoring of~     HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The~     test will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory~     assays. Results of the test will show if HIV/AIDS patients successfully responded to cART.~     Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive~     AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited~     to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or~     early HIV patients, and HIV-negative patients with hepatitis).~      The saliva samples will be used to measure SRP biomarker concentrations. Results will show~     whether the biomarker measurements provide accurate and specific diagnostics for ART~     response.~   "
118326|NCT01507129|"~     Low levels of dehydration (the loss of body water corresponding to 2% of the body weight),~     deteriorate physical and cognitive performance and may also be linked to a number of chronic~     diseases. The standard test used for the assessment of hydration status is plasma~     osmolality. This blood test is invasive, requires time and laboratory equipment and is not~     accurate for isotonic dehydration. The goal of this project is to determine whether a new~     molecular technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used~     for non-invasive diagnostics of dehydration.~   "
118327|NCT01507116|"~     The study is conducted in Africa, Asia, Europe, Japan, North America and South America.~      The multinational surveys will explore the experiences and unmet needs of people with~     diabetes, as well as those of family members of people with diabetes, and of healthcare~     professionals treating people with diabetes.~   "
118328|NCT01507103|"~     The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25)~     administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects~     with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.~      Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune~     rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in~     all colorectal cancers and since the adaptive immune system plays a role in the prognosis of~     rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might~     boost the tumor-specific immune response and increase the number of tumor-infiltrating~     lymphocytes (TILs).~   "
118329|NCT01507090|"~     In 'real-world' health care settings there exist a number of circumstances where the weight~     of a child is desirable or even necessary but unavailable. Numerous weight estimation~     strategies have been described but each has limitations. Investigators at Children's Mercy~     Hospitals and Clinics recently developed a weight estimation method and tool that addresses~     the limitations of previously published methods. This study is intended to validate the~     device in a population of children 2 months to 16 years of age.~   "
118330|NCT01507077|"~     The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD),~     safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).~   "
118331|NCT01507064|"~     The purpose of this study is to determine whether neoadiuvant therapy with sorafenib~     increases the efficacy of thermal ablation in inducing the necrosis of hepatocellular~     carcinoma.~   "
118332|NCT01507051|"~     The study objective is to investigate the pharmacodynamics (effects of a drug product) when~     switching the treatment from warfarin to rivaroxaban.~      84 young, healthy subjects will participate; they will be treated following a randomized,~     parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind~     (Treatments A and B) design.~      The first two groups (A, B) will receive warfarin for approximately one week to adjust their~     blood coagulation values to a specific level, i.e. to maintain an INR (international~     normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant~     treatment.~      The first group (A) will receive rivaroxaban for four days, the second group (B) will take~     placebo. On the last day, all subjects in groups A and B will receive vitamin K to~     neutralize the effects of warfarin. The third group (C) will not undergo prior treatment~     with warfarin but will receive rivaroxaban for four days.~   "
118333|NCT01507038|"~     The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617~     after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to~     investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of~     treatment period and 8weeks of follow-up period without treatment.~   "
118334|NCT01507025|"~     The purpose of this study is to investigate the possible effect of hinge location on corneal~     sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).~   "
118335|NCT01507012|"~     Polyphenols, compounds found at high levels in berry fruit, have been shown to have health~     promoting benefits through various mechanisms both in vivo and in vitro. These benefits~     include antioxidant activity, anti-inflammatory properties, and monoamine oxidase (MAO)~     inhibition. This study aims to expand on the extremely promising animal data in the~     literature, and our own pilot study results, to investigate whether drinks containing berry~     fruit can improve cognitive performance and mood in healthy human participants.~      Our central hypothesis is that fruit extracts can reduce the breakdown of neurotransmitters~     such as dopamine and serotonin. This reduction in breakdown could therefore increase the~     levels of these neurotransmitters and convey some benefits in regards to mood and cognitive~     function. The investigators will assess the pharmacokinetic activity of berry fruit extracts~     on MAO activity to test this hypothesis.~      A second hypothesis is that berryfruit polyphenols may alter circulating levels of glucose~     that may in turn affect cognitive performance and mood.~      A prior study carried out by Plant & Food Research through collaboration with the University~     of Northumbria, UK, found promising results after acutely supplementing participants with a~     berry fruit based drink. This study aims to use the results from the previous study to~     assess in depth the effect of berry fruit drinks on human behaviour.~   "
118336|NCT01506999|"~     The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is~     the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the~     development and testing of new cost-effective technologies exploiting the growing knowledge~     in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data~     obtained by the GENOCOR-Lab should especially orient secondary prevention and specific~     treatment of ischemic heart diseases (IHD).~   "
118337|NCT01506986|"~     HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo~     controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer~     bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting~     centres across the UK. This trial is funded by the National Institute of Health Research~     Health Technology Assessment (NIHR HTA) Programme.~      Aspirin use is widespread and increasing in elderly patients. The main hazard is~     gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This~     trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly~     in H. pylori positive people.~      Patients will be identified by their GPs, then asked to attend an appointment with a~     Research Nurse to consent to the trial and take a H. pylori breath test. Those with a~     positive result will be randomised to receive a one week course of either eradication~     treatment or placebo. No follow-up visits are required, but instead information will be~     extracted from the patients' electronic medical record using the MiQuest search tool.~      The trial will continue until 87 adjudicated events (hospitalisation because of definite or~     probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient~     years of follow-up, if trial assumptions are correct.~   "
118338|NCT01506973|"~     In this Phase I/II clinical trial, the investigators seek to pilot the addition of~     Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer,~     gemcitabine/nab-paclitaxel. The investigators plan a run-in to define tolerable doses, and~     will explore doses of 800 and 1200 mg/day in successive cohorts of 6 patients. The~     investigators will assess toxicity continuously, and determine the dose for the Phase II~     trial based on standard toxicity criteria.~      The correlative endpoints of this trial are directed to the pharmacokinetics of HCQ, and~     pharmacokinetic model of HCQ based on data from several ongoing trials, and the data from~     these patients will contribute to refining the model. The investigators will analyze both~     measured and model-predicted indices for their relationship to autophagy induction.~     Autophagy will be assessed as the accumulation of autophagocytic vesicles in the PMNs of~     treated patients, together with the induction of the expression of autophagy-related~     proteins on western analysis, quantitated by densitometry. The investigators will document~     the rates of metabolic response as a consequence of treatment, as a therapeutic marker that~     may be related to the degree of autophagy inhibition. Since the investigators have~     previously demonstrated a key role of JNK1 in the induction of autophagy by chemotherapy,~     the investigators will analyze archival tumor materials to determine variability in this~     marker, as a baseline for potential future trials. Finally, this study will incorporate~     metabolic profiling by mass spectrometry, which will be related to mutations (including~     Kras) in pretreatment tumor specimens. Mutational analysis will be accomplished by targeted~     sequencing or by next-generation sequencing, and the need for fresh tissue for all these~     endpoints will require patients to have a biopsy performed before treatment at at 6-8 weeks~     after beginning treatment. In the previous study of the Hh inhibitor GDC-0973 with the same~     chemotherapy, the investigators were able to obtain repeat biopsies successfully on all~     patients. The importance of these biopsies, to move the science forward in an era in which~     the tools now exist to provide meaningful correlative science, cannot be overstated.~   "
118339|NCT01506960|"~     The purpose of this study is to learn more about lipid rich plaque using Near Infrared~     Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had~     coronary artery stenting and Optical coherence tomography (OCT) imaging.~   "
118340|NCT01506947|"~     This study will be a prospective open label, non-randomised, single-arm, pilot clinical~     study evaluating the Effect of PTH Lowering on erythropoietin consumption in calcitriol~     resistant patients with stage 5 chronic kidney disease.~   "
118341|NCT01506934|"~     A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of~     food on the pharmacokinetics of linifanib.~   "
118342|NCT01506921|"~     Racemic ketamine and S-ketamine are used in clinical practice today. Little is known of~     their difference in effect on cerebral blood flow, volume and metabolism. cerebral blood~     flow (CBF) measuring techniques are limited in time so constant measurement to mirror a~     dynamic process is impossible or very difficult. A novel MRI application, arterial spin~     labeling, offers the possibility that without radiation or contrast, to measure~     semi-continuous CBF with measurements every 60-120 seconds. The investigators will give 14~     healthy volunteers both study drugs in a randomised sequence with one week apart and measure~     regional CBF during the study period of 45 minutes after a sub-anaesthetic bolus dose of 0,6~     mg/kg racemic ketamine and 0,3 mg/kg S-ketamine The investigators hypothesize that there is~     no difference between racemic ketamine and S(+)-ketamine with regards to Arterial Spin~     Labeling (ASL) measured cerebral blood flow.~   "
118343|NCT01506908|"~     Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for~     a cigarette in smokers~   "
118344|NCT01506895|"~     The purpose of this study is to characterize the systemic and ocular safety and~     tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of~     repeat administration of oral darapladib in diabetic macular edema patients with centre~     involvement.~   "
118345|NCT01506882|"~     The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as~     monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in~     the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.~   "
118346|NCT01506869|"~     Phase 1: Baseline investigation (nation-wide survey)~      Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all~     sites as well as for specific type of cancer, such as breast and colorectal cancer.~      Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000~     individuals selected from 20-25 communities stratified according to geographic regions~     (northeast, north, east, south central, northwest, and southwest China), degrees of~     urbanization (large cities [Beijing, Shanghai, and provincial capitals], midsize cities,~     county seats, and rural townships), and economic development status (as assessed on the~     basis of the gross domestic product [GDP] for each province). A comprehensive examination~     including questionnaire, anthropometric measurements, biochemical analysis will be performed~     in each study participant. Diabetes and prediabetes should be diagnosed by OGTT according to~     the WHO 1999 criteria, while the diagnosis of cancer is established on the self-report~     questionnaire and cross checking with the tumor registry or a proof of doctor's diagnosis.~      Phase 2: Cohort follow-up~      Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal~     glucose regulation (NGR).~      Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and~     sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment~     target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.~   "
118347|NCT01506856|"~     The purpose of this study is:~      Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion~     weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every~     3 weeks (dd-TCip therapy).~      Phase B: To compare the efficacy and safety of the following two treatment regimens as~     first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary~     peritoneal cancer.~   "
118349|NCT01506830|"~     During restorative procedures, different isolation methods of the operative field can be~     used to promote moisture control and retraction of the gingival tissues. The aim of the~     present clinical trial is to evaluate the effects of two isolation techniques on the~     clinical performance of Class V restorations, as well on the periodontal conditions of~     restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be~     enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation~     performed with rubber dam and gingival retraction clamp and (2) isolation provided with~     cotton rolls and gingival retraction cord. Both techniques will be used with a saliva~     suction device. All restorative procedures were performed using a self-etching adhesive~     system and a nanofilled composite resin according to the manufacturer's instructions. The~     clinical performance of restorations will be recorded in terms of fracture and retention of~     restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and~     preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement.~     The periodontal condition of restored sites will be evaluated based on the presence of~     supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival~     recession.~   "
118350|NCT01506817|"~     The primary objective of the current pilot study is to analyze MRI contrast-enhancement~     patterns in the hands of patients with fibromyalgia as compared to the findings in healthy~     controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with~     those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic~     arthritis.~      Hypothesis:~      Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals~     pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g.~     superficial soft tissues and /or muscle with patterns distinct from those of inflammatory~     joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.~   "
118351|NCT01506804|"~     Many patients experience an effect of steroid injection, however the effect is often short~     lasting and recurrence of symptoms is common. The short term effect of injection has been~     shown to be much better than exercise therapy; however over time the superior effect of~     injection compared to exercise does not last. Injection in combination with exercise therapy~     might be a more sufficient therapy than injection alone. The aim of this study is to~     investigate a combination of steroid injection and a 10 week exercise program. In addition,~     the study tests the validity of clinical impingement tests using ultrasound verified~     impingement as gold standard.~   "
118352|NCT01506791|"~     This is an open label, randomised, 2-way crossover, comparative bioequivalence study.~   "
118353|NCT01506778|"~     Most of gynecological office procedure such as endometrial sampling procedure,~     hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device,~     difficult intrauterine insemination or embryo transfer procedures often require the~     application of a single tooth tenaculum to the cervix for steady the cervix, straighten the~     cervicouterine angle and provide countertraction. However, grasping the cervix with a~     tenaculum can be a painful experience for the patient.A randomized controlled trial was~     conducted to evaluate using of tenaculum on pain perception of the patients and the~     procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.~   "
118354|NCT01506765|"~     The results of the study schizophrenia, related disorders and glutathione conducted at the~     Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis~     proposed that a deficit intracerebral glutathione is a vulnerability factor for~     Schizophrenia at least for a subgroup of patients. While pursuing the baseline study, it is~     appropriate now to try to restore a higher level of glutathione in patients to see if this~     increase is accompanied by an improvement in symptoms, particularly negative symptoms and~     disorders cognitive, particularly resistant to current therapy. N-acetyl-cystein (NAC) is a~     precursor of glutathione which is used clinically for various indications, well tolerated~     even at high doses. The investigators propose a double-blind cross-over with the aim to~     study if the N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising~     glutathione brain (measured in resonance magnetic spectroscopic) and also improved patients'~     conditions (determined by clinical assessments, psychopathological, neuropsychological,~     biochemical and physiological), while recording any side effects. As a first step, this~     study should include at least thirty patients and last for two to three years. It is~     important to note that this is not a study of medication suggested by a pharmaceutical~     industry, but a medical search.~   "
118355|NCT01506752|"~     The purpose of this study is to investigate the bioequivalence of improved and current~     orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males~     for each of two administration methods (with/without water).~   "
118356|NCT01506739|"~     The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5~     g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated~     tablet (5 mg) in Japanese healthy adult males.~   "
118357|NCT01506726|"~     The purpose of this study is to determine whether treatment of unexplained anemia in older~     adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels~     and improve physical activity and quality of life.~   "
118358|NCT01506713|"~     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's~     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75~     mg tablet under fasting condition.~   "
118359|NCT01506700|"~     This is a single-arm, prospective, study of an optical imaging device on approximately~     twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging~     will be performed on study subjects with results being compared to final pathology.~   "
118360|NCT01506687|"~     Patients who receive tailored navigation (consisting of a letter and patient navigation~     services) and get screened will be significantly greater than the control group who receives~     treatment as usual.~      A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their~     preferred tests, after undergoing the Patient Navigator intervention and that proportion~     will be significantly greater than the group who opt for FOBT in the control group.~   "
118361|NCT01506674|"~     Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be~     checked for possible correlations between metabolomics patterns and patients' outcomes.~   "
118362|NCT01506661|"~     Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV)~     that usually occurs decades following initial exposure. The risk of developing shingles~     increases with age. Shingles presents as a painful, itchy blistering rash that usually~     involves a single portion of the skin and lasts about 7-10 days. The risk of developing~     shingles increases with age in healthy people, and has been shown in some studies to be~     increased in people with rheumatoid arthritis and other autoimmune diseases.~      Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved~     by the FDA for the prevention of Shingles among people 60 years and older, and is now~     approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of~     the medications used to treat rheumatoid arthritis can impair the body's immune system, it~     is not known how much of an immune response can be generated in people with rheumatoid~     arthritis.~      The goals of this study are to measure the immune response after standard vaccination with~     Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune~     systems. All participants will be 50 years old or older, and subjects with rheumatoid~     arthritis will not be eligible if they are taking certain biologic medications, including~     TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with~     rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be~     followed for 12 weeks to assess the immune response and for the development of local rash or~     other potential side effects.~   "
118363|NCT01506648|"~     Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young~     children immediately after the addition of the enzyme phytase. A randomized single blind~     study~   "
118364|NCT01506635|"~     In this randomized controlled clinical trial, we compare the effects of timolol versus~     placebo for treatment of myopic regression after LASIK~   "
118365|NCT01506622|"~     The occurrence of emergence agitation (EA) in pediatric patients who have received~     sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies~     between 10% to 80% depending on the scoring system for evaluation and the anesthetic~     technique used.~      Many authors reported various strategies such as use of sedative premedication, change of~     maintenance technique of anesthesia, or pharmacological agents administered at the end of~     anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from~     sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end~     of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration~     of anesthesia excessively when these agents are administered as subhypnotic or small dose.~     The typical agents that can be administered in this way are propofol and fentanyl.~      Previous studies demonstrated that the use of either propofol or fentanyl at the end of~     anesthesia could reduce the incidence of EA.~      The purpose of this study is to compare the preventive effect on EA and the characteristics~     of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane~     anesthesia.~   "
118366|NCT01506609|"~     The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide~     or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally~     recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast~     cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.~   "
118367|NCT01506596|"~     The purpose of this study is to evaluate the effectiveness and safety of single agent~     pazopanib in subjects with unresectable or metastatic liposarcoma.~   "
118368|NCT01506583|"~     Currently effective antivials for influenza treatment are two influenza viral neuraminidase~     inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is~     reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is~     that the signal ratio of two reagents (with or without a single concentration of the drug)~     correlates the IC50 value, an accurate measurement of drug resistance but impractical for~     clinical use.~   "
118369|NCT01506570|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will evaluate the~     safety and immune responses to two formulations of a tetravalent dengue virus vaccine in~     healthy adults who have previously been infected with a dengue virus or other flavivirus or~     have previously received a flavivirus vaccine.~   "
118370|NCT01506557|"~     The investigators would like to test the hypothesis that maternal vitamin D supplementation~     during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is~     more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate~     maternal vitamin D status and could be beneficial for maternal and infants bone~     mineralization and body composition (proper proportion of muscle and fat tissues in body~     weight) and is safe for both.~      The investigators also want to confirm that vitamin D supplementation of exclusively~     breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status~     independently of mother's vitamin D supplementation up to 1200 ID/d.~      Additionally the investigators hypothesize that because of changes in lifestyle there will~     be no substantial seasonal differences in vitamin D status of pregnant women at the delivery~     and their newborn infants.~   "
118371|NCT01506544|"~     Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to~     treat adults with sickle cell anemia. Hydroxyurea has also been tested and used with~     children with sickle cell anemia. However, there are not many studies describing the~     disposition of drug in children less than 5 years old. The FDA has requested this study to~     better understand how children ages 2 to 17 years with sickle anemia absorb and eliminate~     the drug (this is called pharmacokinetics). The investigators will measure how much~     Hydroxyurea (HU) gets into the bloodstream at different time points after taking this~     medication.~   "
118372|NCT01506531|"~     The objective of this study is to scientifically evaluate two different closure strategies~     for gastroschisis to determine if there is a difference in the two approaches.~   "
118373|NCT01506518|"~     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging~     method, Double-Push Acoustic Radiation Force (DP ARF) ultrasound, to monitor the progression~     of Duchenne muscular dystrophy. The hypothesis being tested is that DP ARF ultrasound~     delineates changes in muscle composition and function in individual dystrophic muscles, from~     early through late stages of disease development, that correlate to time to loss of~     ambulation in patient volunteers.~   "
118374|NCT01506505|"~     Background and rationale:~      In clinical practice, antihypertensives are generally prescribed for use in the morning,~     whereas some statins are recommended for use in the evening. There is evidence that the~     reduction in LDL cholesterol achieved with some statins is superior when taken in the night,~     but it is unclear whether the additional reduction in LDL cholesterol(and the reported~     improvement in BP control when aspirin is taken in the evening) is offset by a reduction in~     adherence when taking medication in the evening. Current product labelling recommends night~     use for simvastatin and does not state a timing preference for aspirin or blood pressure~     lowering medicines. There is therefore uncertainty concerning the best timing of~     administration of the polypill. This uncertainty will be addressed by this trial.~      Trial design:~      Randomised, open label cross over trial (n=75) of the polypill in the morning compared with~     the evening administration compared with individual agent administration (acetylsalicylic~     acid and blood pressure lowering agents in the morning, and statin in the evening) in~     individuals at high risk of cardiovascular disease. Patients will be recruited to the RHP 2c~     (acetylsalicylic acid 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorthiazide 12.5mg),~     and will be randomly allocated to the sequence of time of administration.~   "
118375|NCT01506492|"~     The purpose of this study is to test the effectiveness of a brief manualized individual~     psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and~     promote psychological well-being in patients with various types of cancer, including~     metastatic disease.~   "
118376|NCT01506479|"~     The purpose of this study is to learn more about the effects of exercise on patients who~     have been recently diagnosed with Parkinson's disease (PD). The investigators are going to~     test two levels of exercise (moderate to vigorous) against no exercise. The investigators~     think that exercise may reduce the symptoms the of PD, and the investigators hope to learn~     what level of exercise will offer the most benefit.~   "
118377|NCT01506466|"~     Weight variation has been reported as a side effect of chemotherapy treatment in early~     breast cancer patients. To date, there is growing evidence for an increased risk of relapse~     and death in these patients who gain or lose weight. However, causes of weight variation~     during chemotherapy and mechanisms involved in the poor prognosis have been little studied.~      Thus, the investigators are conducting a prospective study to characterize weight variation~     in terms of body composition and to identify the mechanisms involved.~   "
118378|NCT01506453|"~     Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of~     vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric~     patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable~     dosing and scheduling regimens, and with varying measures of success. The hypothesis of the~     study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine~     during treatment for ALL on the Total XVI protocol (or for those being treated as per~     TOTXVI protocol), as measured by two outcome measures: the daily dose of morphine used as~     needed for pain in addition to either gabapentin or placebo, as randomized, and the pain~     scores assessed daily.~   "
118379|NCT01506440|"~     This pilot clinical trial studies cognitive assessments in patients with cancer undergoing~     chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help~     identify the side effects of chemotherapy.~   "
118380|NCT01506427|"~     The purpose of this trial is to determine what will be the optimal imaging protocol for Head~     and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for~     future studies involving [F-18]HX4 in cancer patients.~   "
118381|NCT01506414|"~     The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO)~     in combination with Rituximab are effective and safe in the management of~     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).~   "
118382|NCT01506401|"~     What is the effect of early high frequency oscillation (HFO) versus a lung-protective~     conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause~     hospital mortality among patients with severe early acute respiratory distress syndrome~     (ARDS)?~   "
118383|NCT01506388|"~     The use of foley catheter was tested many times and proved to be effective for induction of~     labour.~   "
118384|NCT01506375|"~     The aim of the study is to compare the safety, clinical tolerability, immunogenicity and~     efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating~     adjuvant, in a short course administration (5 injections over 4 weeks).~   "
118385|NCT01506362|"~     The objective of the proposed study is to determine whether BL-7040 demonstrates clinical~     efficacy in patients with inflammatory bowel disease (IBD).~   "
118386|NCT01506349|"~     Many patients with celiac disease complain of neurocognitive symptoms such as mental~     confusion, grogginess, difficulty with concentration and forgetfulness after exposure to~     gluten. However, there is little data on any possible association between impaired cognitive~     function and gluten intake in celiac disease. The investigators predict that patients with~     celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as~     confusion, forgetfulness and difficulty concentrating.~      The goals of this study are to determine the prevalence of neurocognitive symptoms after~     exposure to gluten in patients with celiac disease and to characterize the nature of these~     symptoms both in terms of their duration and severity.~   "
118387|NCT01506336|"~     The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at~     50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to~     imatinib.~   "
118388|NCT01506323|"~     The aim of this study was to determine the usefulness of a portable, meditation-based~     intervention called the Mantram Repetition Program (MRP) for Veterans with military-related~     posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP~     to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego,~     California, and Bedford, Massachusetts.~   "
118389|NCT01506310|"~     The purpose of the study is to test whether four lifestyle intervention programs (diet~     alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and~     exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women~     to improve their metabolic pattern, and decrease the incidence of adverse maternal and~     neonatal outcomes.~   "
118390|NCT01506297|"~     Subjective measures of satiety are correlated with biologic mechanisms of appetite control.~   "
118392|NCT01506271|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125~     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with~     Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the MK-7655 +~     imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin~     alone with respect to the proportion of participants with a favorable clinical response at~     completion of intravenous (IV) study therapy.~   "
118393|NCT01506258|"~     The purpose of this study is to determine whether the plasticity of autologous intravenous~     application of cord blood stem cells would improve the clinical course of asphyxiated~     newborns.~   "
118394|NCT01506245|"~     The aim of this study is to compare the effects of exercise training and family-based~     behavioral treatment, either in individual or in group setting, in pre-pubertal children and~     their mother.~   "
118395|NCT01506232|"~     The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in~     diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls~     (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using~     brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty~     without any of the disorders under study (controls) will be evaluated. All subjects will be~     comprehensively assessed with structured diagnostic interviews and neuropsychological~     testing. All EEG analyses will be conducted under blind conditions. Conditional probability~     and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of~     the EEG scan, using the clinical diagnosis of ASD as the gold standard.~   "
118396|NCT01506219|"~     Introduction:~      Elderly with multiple illnesses represent the fastest growing sector of society and make~     increasing demands on all sectors of the health care system, particularly in community~     rehabilitation units due to shorter time of stay in acute care units and hospitals. The aim~     of this study is to investigate the effect of geriatrician-performed comprehensive geriatric~     assessments and intervention with follow up (CGC) in elderly referred to a rehabilitation~     unit.~      Methods:~      The study is a prospective randomized controlled trial. Settings: two community care~     rehabilitation units in Aarhus Municipality, Denmark. Inclusion: elderly aged 65 and older~     from home or hospital. Exclusion: elderly who received palliative care or had been assessed~     by a geriatrician during the past month. Intervention: medical history, physical~     examination, blood tests, medication adjustment and follow up by a geriatrician. Control:~     standard care with the general practitioners (GPs) as back-up. Hospital contacts (primary~     outcome), GP contacts, activities of daily living (ADL), physical and cognitive functions,~     quality of life, institutionalization, medication status, and mortality were assessed at day~     30 and 90 after arrival at the rehabilitation unit. preliminary~      Preliminary results:~      In total, 370 persons were randomized (184 control/186 intervention group). The mean age was~     77.9±7.9/78.3±8.3 years. No difference in mortality was demonstrated. Analyses on hospital~     contacts, GP contacts, activities of daily living (ADL), physical and cognitive functions,~     quality of life, institutionalization, medication status are ongoing.~   "
118397|NCT01506206|"~     The investigators propose a test of causality by examining a cohort of patients undergoing~     deep brain stimulation (DBS) within the ventral striatum. The investigators will examine~     behavior on and off stimulation across a range of tasks that index different forms of~     impulsivity. Patients will be studied in both the ON and OFF state - that is, they will be~     tested during active deep brain stimulation and 30 min to 1 hour after stimulation has been~     stopped (order of state will be counterbalanced across subjects). The investigators specific~     aim is to test the hypothesis that enhancing ventral striatal signaling (i.e. ON-state DBS)~     will cause more impulsive patterns of behavior across several impulsivity tasks. The~     investigators predict that ventral striatal DBS will increase stop-signal reaction time on~     the stop-signal task and commission errors on the Go/NoGo task, and increase delay aversion~     in a delay discounting paradigm.~   "
118398|NCT01506193|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136,~     PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine~     (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.~   "
118399|NCT01506180|"~     The purpose of this study is to compare acute ill elderly medical patients in a geriatric~     department with general medical departments, and to examine the effects of comprehensive~     geriatric assessment in the geriatric setting compared with general medical care.~   "
118400|NCT01506167|"~     This prospective, multi-center, observational study will assess the safety and efficacy of~     Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who~     have received no previous treatment for advanced disease and are receiving Avastin in~     combination with a standard of care first-line chemotherapy regimen. Data will be collected~     for 1.5 years or until death.~   "
118401|NCT01506154|"~     A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the~     Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the~     Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis~     and/or Subdeltoid Bursitis of the Shoulder.~   "
118402|NCT01506141|"~     Elaprase, a large molecular protein, is not expected to cross the blood brain barrier when~     administered intravenously. A revised formulation of idursulfase, idursulfase-IT, that~     differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be~     suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration.~      This extension study of HGT-HIT-045 is designed to collect long-term safety data in~     pediatric patients with Hunter syndrome and cognitive impairment who are receiving~     intrathecal idursulfase-IT and intravenous Elaprase enzyme replacement therapy.~   "
118403|NCT01506128|"~     The investigators tried to know whether a virus causing cervical cancer could be detected in~     menstrual blood and to set up a experimental setting to detect the virus.~   "
118404|NCT01506115|"~     The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC)~     is dismal even after biliary drainage; due to malfunction of the biliary drainage tube~     caused by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar~     cholangiocarcinoma improves biliary drainage and prolongs survival. The aims of this study~     were to assess the safety and efficacy of PDT in unresectable HCC with bile duct invasion.~   "
118406|NCT01506089|"~     Many human and animal studies over the past 40 years have revealed that ovaries and~     Fallopian tubes have a lower temperature than core body temperature, especially around the~     time of ovulation and early embryo development. Whether average core body temperature, 37~     degrees Celsius, is ideal temperature for culture has not been prospectively evaluated. The~     purpose of this study is to determine whether lowering the incubator temperature by 1 degree~     Celsius will result in meaningful improvements in embryo development and pregnancy rates.~      Patients participating in this study will undergo routine in vitro fertilization (IVF)~     stimulation. Following egg retrieval, patients with at least 8 mature eggs will have those~     eggs divided randomly into two groups. Both groups will then under ICSI (intra-cytoplasmic~     sperm injection) to fertilize the eggs. The groups will randomly be assigned to control or~     study condition. The control condition group will be cultured at 37 degrees Celsius, the~     current standard of care. The study group will be cultured at 36 degrees Celsius. All other~     culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of~     development.~      On day 5, all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal~     Screening (CCS), which will evaluate the chromosomal normalcy of the embryo . Patients will~     undergo transfer on the morning of day 6 and the highest quality, chromosomally normal~     embryo from each group (the 36 degree cultured embryos and the 37 degree cultured embryos)~     will be transferred. If only 1 embryo is available for transfer, the patient will have a~     single embryo transfer.~      All embryos available for cryopreservation will undergo biopsy for CCS before being frozen.~     Some arrested embryos from each temperature group will also undergo genetic analysis to~     evaluate chromosomal normalcy or mosaicism.~      The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be~     obtained from the infant(s) after birth.~   "
118407|NCT01506076|"~     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets~     5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance, under fasting conditions.~   "
118408|NCT01506063|"~     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets~     5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory~     investigations and assess relative safety and tolerance, under fed conditions.~   "
118409|NCT01506050|"~     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence~     study.~   "
118410|NCT01506037|"~     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence~     study.~   "
118411|NCT01506024|"~     The aim of the present study is to explore the most efficient surgical approach in total hip~     replacement in short and long term when concerning strength, functionality and postoperative~     complications.~      The objective is to register muscular strength, hip joint functionality/mobilisation and~     complications after total hip arthroplasty (THA) performed by the direct lateral approach~     (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified~     Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).~      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the~     muscles, patients will tolerate early hospital discharge better after the AA than the PA and~     the DLA. Patients in the AA group are also thought to be more active and maintain muscular~     strength and hip joint functionality/mobilisation better than patients in the lateral group.~   "
118412|NCT01506011|"~     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl~     10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical~     status, adverse events and laboratory investigations and assess relative safety and~     tolerance under fasting conditions~   "
118413|NCT01505998|"~     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl~     10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical~     status, adverse events and laboratory investigations and assess relative safety and~     tolerance under fed conditions.~   "
118414|NCT01505985|"~     Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency.~     Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip~     fracture. Notably, several clinical trials with protein supplementation in senior hip~     fracture patients resulted in fewer deaths, shorter hospital stay, and a higher likelihood~     of return to independent living. The proposal is to test the effect of an oral nutritional~     supplement (ONS) which has been designed to meet the specific nutrient needs of senior bone~     and muscle health. The hypothesis is that this ONS will improve functional recovery after~     hip fracture (as measured by Short Physical Performance Battery (SPPB)), improve quality of~     life, improve muscle mass, and- decrease falls and hospital re-admission after hip fracture.~   "
118415|NCT01505972|"~     The attendance rate to population based primary screening colonoscopy within NordICC trial~     (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%.~     The aim of this study is to compare the effect of two different time schedules for sending~     invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600~     screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to~     receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR~     and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome~     measures are participation in screening colonoscopy within 6 months from the date of~     invitation, response and acceptance rate before sending a reminder. The study is powered to~     detect 7% difference in participation in screening colonoscopy.~   "
118416|NCT01505959|"~     Targeted population:~      Sleep apnea patients at high cardiovascular risk newly treated by CPAP~      Hypothesis:~      Improvement in blood pressure after 6 months of CPAP treatment might be greater in the~     telemonitoring arm compared to usual CPAP care.~      Main goal:~      To compare 6-months blood pressure reduction when Sleep Apnea patients at high~     cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and~     coordinated follow-up based on a telemonitoring web platform.~   "
118417|NCT01505946|"~     This is an observational, prospective, longitudinal, multicenter, cohort study designed with~     the scope to verify whether or not TGA may predict effectiveness of different FVIII~     concentrates class (devoid or rich of VWF) in patient affected by severe or moderately~     severe inherited haemophilia A and inhibitors.~   "
118418|NCT01505933|"~     Sedation is required in infants and children to successfully complete MRI while maintaining~     respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk~     during MRI examination. Therefore, appropriate drugs need to be selected, administered, and~     titrated to achieve these objectives. Propofol is commonly used for sedation in children in~     the MRI setting because of its predictability, rapid onset, and offset of action.~     Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and~     respiratory stability. The rationale of this research is to assess the effect of these drugs~     on the upper airway and validate their use in children with upper airway disorders.~   "
118419|NCT01505920|"~     Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for~     diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several~     methods have been proposed to reducing pain including submucosal block, paracervical block,~     and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine~     appeared to be the most common methods used. However, from the investigators experience,~     there is significant pain associated with the injection itself.~      Lidocaine spray is an effective measure for pain control during minor gastrointestinal and~     otolaryngological procedures. It is simple without pain related to application.~      An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine~     submucosal injection by comparing pain scores at various stages of the LEEP procedure.~   "
118420|NCT01505907|"~     The primary objective of this dose escalation study is to examine the safety, tolerability,~     and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy~     male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number~     of dose levels, as well as the dosages, may be adjusted after evaluation of in-study~     analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to~     identify the maximum tolerated single dose of CXB909.~   "
118421|NCT01505894|"~     The primary objective of this trial was to investigate safety and tolerability of multiple~     doses of BI 409306 in healthy young and elderly volunteers.~      The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple~     doses of BI 409306 in healthy young and elderly volunteers~   "
118422|NCT01505881|"~     To collect additional data relating to safety and indicators of efficacy for patients who~     have participated in the 1160.113 study.~   "
118423|NCT01505868|"~     This clinical research study is made up of 2 groups and 2 phases.~      The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination~     of cabazitaxel, carboplatin, and prednisone that can be given to patients with metastatic~     CRPC.~      The goal of Phase 2 of this study is to learn if adding cabazitaxel to the combination of~     carboplatin and prednisone affects how the disease is controlled in patients with metastatic~     CRPC.~      In both of these phases, the drug combinations will be compared to cabazitaxel alone.~      The safety of the drug combinations will be studied in both phases and groups.~      Cabazitaxel and carboplatin are both designed to interfere with the growth of cancer cells~     by stopping cell division.~      Prednisone is a corticosteroid that is similar to a natural hormone made by your body. It is~     often given in combination with other chemotherapy to treat cancer.~   "
118424|NCT01505855|"~     A growing number of patients with Crohn's disease are treated with immunosuppressive agents,~     such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies~     have indicated that immunosuppressive treatment may impair the immunological response to~     pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and~     Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific~     disease, such as Crohn's disease. In addition, predictive factors affecting impaired~     response following pneumococcal vaccination have not clearly evaluated in patients with~     Crohn's disease. In this study, patients with Crohn's disease will be assessed for~     serological response to pneumococcal vaccination. Further, potential predictive factors that~     impact on vaccination outcomes and adverse events related to vaccination will be evaluated.~   "
118425|NCT01505842|"~     Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an~     increased risk of developing cancer. The purpose of this study is to determine if~     visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in~     detection of more abnormalities than conventional colonoscopy without dye spray.~   "
118426|NCT01505829|"~     This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring~     treatment response in ovarian cancer metastases and assess its potential in monitoring~     treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across~     multiple centres and platforms, assessing reproducibility of the measurement in patients~     planned for neoadjuvant chemotherapy and assessing its utility as an early response~     biomarker in patients with platinum-sensitive relapse due to receive therapy with~     carboplatin. Scanning measurements will be correlated with histopathological markers in~     tumour samples in order to link the biomarker with response mechanisms.~   "
118427|NCT01505816|"~     This prospective nonrandomized study comprised patients with cataract, corneal astigmatism,~     and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric~     Intraocular Lens will be implanted in the capsular bag. Three months postoperatively,~     distance, intermediate, and near visual acuities; spherical equivalent; residual refractive~     astigmatism; defocus curve; and contrast sensitivity will be evaluated. A~     patient-satisfaction and visual phenomena questionnaire will also be administered.~   "
118428|NCT01505803|"~     Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of~     diabetes-associated deaths being attributed to cardiovascular complications. The~     characterising features of DM include: the presence of chronic hyperglycaemia, consequent~     upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of~     oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been~     shown to influence each of these outcomes via several mechanisms. This pilot study will~     examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes~     in a population with type 2 DM.~   "
118450|NCT01505517|"~     The aim of the study is to clarify whether specific loading of the inspiratory muscles~     induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals~     with recurrent low back pain.~   "
118451|NCT01505504|"~     Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has~     weight loss as a frequent side effect.~      The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can~     counteract weight loss in patients with AD or mixed dementia (AD + vascular).~   "
118452|NCT01505491|"~     This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and~     to establish pharmacokinetic equivalence of BI 695501 to adalimumab.~   "
118453|NCT01505478|"~     The investigators will conduct a prospective cohort study to compare an automated sepsis~     severity score to a conventional clinical prediction rule to risk stratify patients admitted~     from the emergency department (ED) with suspected infection for 28 day in-hospital~     mortality.~   "
118429|NCT01505790|"~     Acute coronary syndromes are related to the development of a platelet derived thrombus on a~     ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a~     significantly reduced the risk of major adverse cardiovascular events (MACE) after~     percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the~     rate of MACE in patients treated using PCI and particularly in those suffering of an acute~     coronary syndrome is around 5% in randomized trials. Within the factors associated with~     MACE, high on treatment platelet reactivity following clopidogrel loading dose has been~     identified as a key factor. In fact it is widely recognized that there is a large inter~     individual variability in clopidogrel responsiveness. In addition several authors have~     demonstrated a strong link between high on treatment platelet reactivity following~     clopidogrel loading dose and the occurrence of post PCI MACE. Vasodilator Phosphoprotein~     index measurement (VASP index) enables a reproducible, standardized and specific assessment~     of clopidogrel responsiveness.~      The investigators previous works have demonstrated that a VASP index ≥ 50% had a high~     negative predictive value for post PCI MACE in patients undergoing PCI and that tailored~     clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a~     reduction in the rate of post PCI MACE.~      Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet~     effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post~     PCI MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an~     excessive blockade of platelet reactivity responsible for a significant increase in bleeding~     events in some patients and an insufficient blockade in up to 325% of the remaining~     patients.~      Therefore the investigators hypothesized that a strategy of individually tailored loading~     and maintenance dose of clopidogrel may be superior to prasugrel standard therapy in~     achieving an optimal platelet reactivity inhibition in acute coronary syndrome patients~     undergoing PCI.~   "
118430|NCT01505777|"~     The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and~     Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.~   "
118431|NCT01505764|"~     Cancer is often coupled with a condition called cachexia. In this condition, individuals~     continue to lose weight and lean body mass, which means their muscles are getting smaller~     and weaker. Studies have shown that cancer patients who are losing weight often are~     responding poorly to chemotherapy, are at greater risk of infection and have a reduced life~     expectancy. Also, people may not want to eat. To date, there are no approved treatments~     available for this condition.~      This study is going to study the benefits of the use of the study drug, Anamorelin~     hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies~     done before with the study drug have shown that the drug can help the cachectic condition.~     The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl~     compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including~     measurements of body potassium and nitrogen stores.~      In addition to the above, the study will also assess the effect of the study drug on~     handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake,~     certain blood markers, energy expenditure (the amount of energy participants burn),~     functional performance, safety and tolerability of Anamorelin HCl.~   "
118432|NCT01505751|"~     G9a protein was approved to be highly associated with recurrence of breast cancer, gastric~     cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this~     study was to clarify the association and G9a protein and cervical cancer by analyzing the~     immunohistochemical staining of G9a protein to the histopathologic specimen of cervical~     cancer and clinical data.~   "
118433|NCT01505738|"~     The amount and species of bacteria have been shown to have an effect in wound infections in~     several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery~     of facial area). In vascular surgery, wound infections are a common and expensive~     complication. The aim of the present study is to investigate the prevalence of bacteria in~     vascular surgery wounds perioperatively, and determine whether is correlates with the~     incidence of wound infections postoperatively.~   "
118434|NCT01505725|"~     Background:~      - Researchers have been studying behavioral components of nicotine addiction by looking at~     how drugs have a reinforcing effect, connecting the stimulation provided by the drug~     (nicotine) to the behavior that produces it (smoking). Based on previous studies,~     researchers are interested in learning more about how nicotine affects current smokers'~     responses to psychological tests and smoking-related cues, and in studying whether certain~     kinds of genetic background may affect smokers' responses to these kinds of studies.~      Objectives:~        -  To compare the effect of nicotine versus denicotinized cigarettes during specific~          psychological tests.~        -  To compare the effects of smoking cues versus neutral cues on craving, mood, and~          autonomic response.~        -  To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.~      Eligibility:~      - Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes~     per day for at least 1 year) and are not currently interested in reducing their smoking or~     seeking treatment for tobacco dependence.~      Design:~        -  Pilot session:~        -  Participants will practice smoking using the measuring equipment that will be used in~          the study.~        -  After successful practice, participants will read or listen to music for 1 hour, during~          which they are not allowed to smoke.~        -  After the 1-hour period, participants will sample study cigarettes that have different~          levels of nicotine, and will be asked to guess whether the cigarettes are normal study~          cigarettes or denicotinized cigarettes.~        -  Baseline session:~        -  Blood, urine, and breath samples will be taken at the start of the session.~        -  Participants will smoke part of an initial cigarette, and then will read or listen to~          music for 1 hour, during which they are not allowed to smoke.~        -  After the 1-hour period, participants will give another breath sample and will complete~          questionnaires about mood and concentration levels.~        -  Trial sessions:~        -  Participants will smoke study cigarettes, and will be asked to either respond to~          questions about perceived nicotine levels in the cigarettes or press a lever for the~          chance to be rewarded with additional puffs of the cigarette. After the session,~          participants will give another breath sample and will complete questionnaires about~          mood and concentration levels.~        -  Participants will also participate in cue-reactivity sessions to test the body's~          physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack~          of unsharpened pencils). After the session, participants will complete questionnaires~          on mood and concentration 15, 30, 45, and 60 minutes after the session.~        -  At the conclusion of the last experimental session, participants will discuss the study~          with researchers, and may receive a referral list of smoking treatment programs.~   "
118435|NCT01505712|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.~   "
118436|NCT01505699|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in samples from patients with acute~     lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.~   "
118437|NCT01505686|"~     MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful~     inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The~     aim of the present study is to determine, whether similar inflammatory changes can be~     detected with MRI scan in inguinal hernia. Also, patient questionaires are used~     preoperatively and postoperatively to determine, if preoperative pain scores can be used as~     a predictive value for postoperative prolonged pain/neuralgia.~   "
118438|NCT01505673|"~     The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a~     high-dose insulin regimen (>1.8 units/kg/day) in patients with uncontrolled (HbA1c >7.5%)~     type 2 diabetes mellitus will improve blood sugar control.~      It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores~     the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release,~     and assesses blood pressure, lipid profile, and liver function. Finally it will look at~     patient quality of life and safety.~   "
118439|NCT01505660|"~     Among HIV-infected patients, adherence to antiretroviral medications is one of the most~     important determinants of clinical outcomes including viral suppression, viral resistance,~     disease progression, and death. Unfortunately poor adherence among patients with HIV is very~     common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug~     abuse, and mental illness particularly depression symptoms are key predictors of poor~     adherence, common among HIV-infected individuals, and important to identify and treat among~     nonadherent patients. This study will examine the ability of patient reported outcomes~     (PROs) and a targeted care management approach to improve clinical outcomes with a~     randomized controlled trial (RCT) in routine clinical care of patients with HIV. The~     investigators will determine whether healthcare delivery team notification of PROs including~     antiretroviral medication adherence and barriers of adherence such as depression and~     substance abuse along with tailored intervention recommendations and targeted care~     management leads to improvement in both process and clinical outcomes including~     patient-reported outcomes. The investigators will examine process outcomes such as use of~     clinic support services, and patient outcomes such as improvement in adherence, substance~     use, depression, and HIV-1 RNA levels.~   "
118440|NCT01505647|"~     This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process~     [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to~     ZOSTAVAX™.~   "
118441|NCT01505634|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125~     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with~     complicated urinary tract infection (cUTI). The primary hypothesis is that the MK-7655 +~     imipenem/cilastatin treatment regimen is non-inferior to imipenem/cilastatin with respect to~     the proportion of participants with a favorable microbiological response at completion of~     intravenous (IV) study therapy.~   "
118442|NCT01505621|"~     Accumulation of damaged proteins is thought to underlie many degenerative conditions,~     including aging, diabetes, Alzheimer's disease, cataracts, and others. Over time, proteins~     can be irreversibly damaged by a variety of factors, such as reactive oxygen species, and~     without timely degradation they can accumulate and aggregate. We believe this can contribute~     to the development of chronic degenerative disorders.~      The purpose of this study is to develop a novel methodology for measuring protein~     accumulation and test it in two groups of people: young (18-30 years) and old (≥65 years).~     This methodology will require that people drink a solution of essential amino acids that~     includes isotopically labeled L[ring-13C6]phenylalanine. We will then collect blood and~     muscle samples, to isolate plasma and skeletal muscle proteins. Participants will return to~     the study center four more times on a weekly interval.~      We hypothesize that older proteins, which persisted in circulation and accumulated over~     time, will have a higher degree of post-translational oxidative damage than newly~     synthesized proteins.~   "
118443|NCT01505608|"~     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for~     early relapsed neuroblastoma. An investigational drug is one that has not yet been approved~     by the Food and Drug Administration. This investigational drug is called TPI 287. This study~     will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan~     and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study~     will also evaluate the safety and tolerability of the study drug, TPI 287.~   "
118444|NCT01505595|"~     Proprioceptive weighting changes may explain differences in postural control performance.~     Deficits in proprioception are found in a subgroup of patients with low back pain.~      The aim of the study is to clarify whether proprioceptive training has a positive effect on~     proprioceptive postural control in individuals with recurrent low back pain.~   "
118445|NCT01505582|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance. Deficits in proprioception are found in a subgroup of~     patients with low back pain. In addition, disorders of respiration have been identified as~     strongly related to low back pain.~      The aim of the study is to clarify whether inspiratory muscle training has a positive effect~     on proprioceptive postural control in individuals with recurrent low back pain.~   "
118446|NCT01505569|"~     This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS~     tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or~     carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral~     blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation~     therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood~     stem cell transplant will be given for 3 cycles.~   "
118447|NCT01505556|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Increased risk of~     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance.~      The aim of the study is to clarify whether proprioceptive postural control is impaired in~     individuals with diaphragm paresis.~   "
118448|NCT01505543|"~     Proprioceptive weighting changes may explain differences in postural control performance. In~     addition, the respiratory movement has a disturbing effect on postural balance. Postural~     balance seems to be impaired in individuals with respiratory disorders. Increased risk of~     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the~     essential role of respiration, the diaphragm may also play an important role in the control~     of the trunk and postural balance.~      The aim of the study is to clarify whether proprioceptive postural control is impaired in~     individuals with chronic obstructive pulmonary disease.~   "
118449|NCT01505530|"~     This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in~     participants with locally advanced/inoperable or metastatic pancreatic cancer, and will~     investigate 2 different doses of LY2495655 in combination with standard of care~     chemotherapy.~   "
118454|NCT01505465|"~     Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by~     patients after undergoing joint surgeries. To address these issues, melatonin, an~     inexpensive over-the-counter supplement, has shown in previous to help manage sleep~     disorders, prevent and treat post-operative confusion in patients over 70 years of age, and~     reduce pain. The purpose of this study is to establish whether melatonin can aid in reducing~     pain and post-operative confusion and improve sleep quality after total knee replacement~   "
118455|NCT01505452|"~     The purpose of this study is to clinically demonstrate a phenomenon of measurement error~     that can occur during placement of a specific type of total knee replacement prosthesis~     (single radius femoral component) using a certain type of surgical technique~     (flexion/extension gap balancing).~   "
118456|NCT01505439|"~     This study is to investigate the effects of solifenacin on urgency urinary incontinence~     symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically~     significant stress urinary incontinence accompanied by urgency urinary incontinence.~   "
118457|NCT01505426|"~     To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian~     subjects with type 2 diabetes mellitus.~   "
118458|NCT01505413|"~     Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth~     factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine~     kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong~     case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the~     addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in~     advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with~     oxaliplatin is superior to gemcitabine alone in terms of progression free survival and~     response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib~     with gemcitabine and oxaliplatin may further improve the overall survival and clinical~     benefit of advanced pancreatic cancer.~   "
118459|NCT01505400|"~     Substantial progress has been made in the treatment of cancer through the use of targeted~     therapies, but what works for one patient might not work for another patient. Certain drugs~     are now being developed that target specific molecules in the body that are believed to be~     part of the disease.~      Biomarkers are specific characteristics of the cancer that may help provide prognostic~     information (i.e. how well patients will be regardless of the treatments given) or help~     predict sensitivity or resistance to a specific treatment.~      The study will collect archival tumor samples (previously collected biopsy or surgical tumor~     samples) to provide biomarker data about a patient's cancer, in order to help their~     physicians to identify which clinical trials of molecularly targeted therapies may be most~     appropriate for the patient in the future.~   "
118460|NCT01505387|"~     The effect of Litramine on weight loss has previously been studied during a 12-week~     intervention period with promising results. The present study looks into the effect of~     weight maintenance using Litramine following initial weight loss, for a longer period of 24~     weeks.~   "
118461|NCT01505374|"~     Currently, the regional anesthetic standard of care for total knee replacement surgery is~     combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve~     block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can~     use to numb the thigh muscle for approximately 18 hours after surgery. While this technique~     offers significant pain relief, it is possible it may cause muscle weakness and increase~     patients' recovery times. Hence there is a need for an alterative anesthetic technique, one~     that may help minimize postoperative pain as effectively as a femoral nerve block, while not~     causing weakness of the thigh muscle.~      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it~     is hypothesized by blocking or anesthetizing the saphenous nerve with local anesthetic~     closer to where it branches off, the area around and below the knee will feel numb. Yet~     unlike the femoral nerve block, the thigh muscle itself will still be able to function.~      For patients undergoing two total knee replacements at one time or bilateral total knee~     replacement, they will be randomly assigned to receive a femoral nerve block on one leg and~     a saphenous block on the other. Pain levels will be measured and thigh muscle strength will~     be tested using a dynamometer before surgery, 6-8 hours following anesthesia administration,~     and on postoperative days 1 and 2.~   "
118462|NCT01505361|"~     In previous studies, the investigators have seen that carefully-selected Lactobacillus~     strains are a good alternative to antibiotics for the treatment of lactational mastitis. The~     objective of this new study is to check if they can also have a preventive role when~     administered to women with a history of mastitis with one or more previous infants. Since~     the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting~     intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of~     resistant bacteria), the investigators would also like to test if administration of the~     strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a~     mastitis-predisposing factor would de avoid.~   "
118463|NCT01505348|"~     This study examined changes in bone metabolism (markers of bone turnover, calcium~     metabolism) with a bout of acute treadmill running preceded by either a single, mixed meal~     or an overnight fast.~   "
118464|NCT01505335|"~     The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device~     in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed~     on computerized tomography images.~   "
118465|NCT01505322|"~     Can pain impairment of daily activities be shown to be procedure specific, and thus used as~     an alternative to pain scoring.~   "
118466|NCT01505309|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of~     Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as~     descending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type B dissection, dissection~     with primary tear located in the aortic arch, et al.~   "
118467|NCT01505296|"~     The objective is to compare the progression of Atrial Fib (AF) burden by continuous~     monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation~     (PVI) versus anti-arrhythmic drug (AAD) therapy.~   "
118491|NCT01504984|"~     The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by~     comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab~     4T (400mg) when administered a single-dose to healthy male volunteers.~   "
118468|NCT01505283|"~     There are many methods used for the assessment of pain in the area of anesthesia including~     heart rate variability which reflects the influence of the autonomic nervous system on the~     heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during~     anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious~     patients with a comparison of ANI with the measurement of pain by a visual analog scale~     (VAS).~      Evaluation of ANI is performed just before epidural catheter insertion and during the 10~     first minutes after saline, sufentanil or lidocaine epidural administration.~   "
118469|NCT01505270|"~     It is known that several psychological and medical comorbidities are frequently found among~     children suffering from autistic spectrum disorders. Our aim is to investigate which~     comorbidities are most common among those children and whether there are differences among~     the different ethnic groups found in Israel.~   "
118470|NCT01505257|"~     Delirium (acute confusion) is common and costly in persons with dementia, resulting in~     longer hospital stays, more complications, and greater functional decline. This research~     tests the use of the electronic health record, education, and regular feedback to nurses to~     improve detection and management of delirium. Ultimately, findings will direct ways to~     improve acute care of this vulnerable population.~   "
118471|NCT01505244|"~     Children in the U.S. exhibit low levels of physical activity. In addition to the overall~     physical health and fitness benefits with increasing levels of physical activity,~     improvements in academic performance, mental cognition, and behavior may occur. Despite~     these benefits, opportunities for children to participate in physical activity are being~     reduced, particularly in schools.~      The proposed study is a pilot program with approximately 100 children ages 7-11 years~     expected to participate. All study participants will partake in a testing and measures~     session which will include body composition measures, nutrition and physical activity~     questionnaires, and curriculum-based measures. Following the first testing and measures~     session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to~     vigorous physical activity (MVPA) program. This program will consist of non-competitive,~     MVPA and occur 3 days/week at their school. Subsequent to the physical activity program, all~     100 children will then participate in a follow-up testing and measures session.~      The objective of this proposed pilot study is to determine the feasibility of implementing a~     before-school, physical activity program as well as explore the effect the program may have~     on academic performance and health measures.~   "
118472|NCT01505231|"~     Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery,~     with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory~     phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can~     be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The~     investigators hypothesized that the use of arginine vasopressin would be more effective on~     treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end~     point of mortality and severe morbidity.~   "
118473|NCT01505218|"~     Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography~     (ERCP). Combination of sedatives and opioids is associated with increased~     morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system~     (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative~     studies with PCS for ERCP are few. Therefore, the main objective of this randomized~     controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists~     during ERCP.~   "
118474|NCT01505205|"~     Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are~     obviously more invasive in case of recurrence. The great majority of relapses may be~     associated with secondary mutation in the GIST related genes. Full gene sequences of~     c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical~     resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with~     the screening-sequencing approach, in order to investigate the characteristics and~     variations associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST~     patients and be likely to find out the evolutionary pattern, try to learn the facts about~     the effect of tyrosine kinase inhibitors on the GIST related genes, make a survey of any~     association of c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking~     molecular marker of GIST for monitoring course of disease, and offer a theoretical basis and~     new therapeutic strategies for application of clinical treatment.~   "
118475|NCT01505192|"~     Aim of this study is to determine the physiological reference individual values (RI) of~     maternal continuous SpHb immediately after delivery in the post-partum period (continuous~     monitoring up to 2 hours after delivery) in order to establish the physiological Hb~     variations in response to the physiological blood loss due to delivery.~      During labor all parturients will be tested for standard Laboratory Hb and monitored for at~     least 30 minutes with SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow~     DiSposable™ Adult Adhesive Sensor), and these values will be considered to be the baseline~     values.~      Immediately after spontaneous vaginal delivery, venous blood sample will be taken for Hb~     determination and Radical 7 equipment for SpHb will be connected to the patient's finger and~     will be recorded for at least two hours after delivery. At the end of this period of~     observation a venous blood sample will be taken for Hb determination. Additional~     measurements of both SpHb and Lab Hb will be performed 24 hours after delivery.~   "
118476|NCT01505179|"~     The purpose of this study is to determine whether treatment with Ranolazine will improve~     exercise capacity in patients with Heart Failure with preserved left ventricular ejection~     fraction.~   "
118492|NCT01504971|"~     Aim of this study is to compare the efficacy of narrow band imaging (NBI) and~     autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux~     that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the~     diagnosis of gastroesophageal reflux disease (GERD).~   "
118493|NCT01504958|"~     This study looks at the potential benefits of combining cognitive training (mental~     exercises) together with transcranial magnetic stimulation (also known as TMS) to see if~     this can make a difference in the condition of people with Alzheimer's disease by improving~     their disease and the cognitive decline that goes along with it.~   "
119042|NCT01497756|"~     A group of midwives and obstetric nurses have been trained to use circumferential abdominal~     pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any~     use of a CAPP device will be monitored to identify complications.~   "
118477|NCT01505166|"~     Preliminary studies with a variety of vaccines suggest target accessibility (potential~     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to~     overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel~     autologous vaccine to address inability to fully identify cancer associated antigens,~     antigen recognition by the immune system (i.e. antigen-->immunogen), effector potency, and~     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer~     vaccines, we designed a novel dual-modulatory autologous whole cell vaccine, Vigil™,~     incorporating the rhGMCSF transgene and the bifunctional shRNAfurin (to block proprotein~     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer~     associated antigens, 2) effect antigen recognition by the immune system, 3) enhance effector~     potency, and 4) subvert endogenous cancer-induced immune resistance. We have also completed~     the Phase I assessment of Vigil™ vaccine in 30 advanced solid tumor patients (1.0 x 10^7~     cells/injection/month for a maximum of 12 vaccinations) who have not experienced any~     significant adverse effects following 144 vaccinations, including 6 patients with colorectal~     carcinoma. Plasmid functionality, immune biomarker response, and preliminary evidence of~     anticancer activity have been observed. This is a two-part Phase II study of the Vigil™~     autologous vaccine. Six patients will be enrolled into the Part 1 of the study to receive~     intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12~     vaccinations). Part 2 of the study will be a randomized Phase II study of sandwich or~     adjuvant chemotherapy and intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7~     cells/injection; maximum of 12 vaccinations) versus sandwich or adjuvant chemotherapy and~     placebo in patients with colorectal carcinoma with either synchronous or metachronous liver~     metastases (CLM +/= pulmonary metastases) following resection +/= ablation with curative~     intent.Sandwich therapy indicates a combination of both pre-operative and postoperative~     chemotherapy as opposed to neo-adjuvant (all chemotherapy prior to surgery) or adjuvant (all~     chemotherapy following surgery) therapy. A minimum harvest aliquot to produce 4 monthly~     injections will be required for entry into the study. Patients in whom insufficient tissue~     (<4 doses) is collected or whose vaccine fails manufacturing release criteria will not~     receive vaccine.~   "
118478|NCT01505153|"~     This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar~     invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single~     intratumoral (IT) injection. Patients with superficially accessible advanced cancer~     following prior therapies will be entered into the study following a modified dose~     escalation design based on the demonstrated safety of our previous clinical experience~     (BB-IND 13744) with the same liposome and vector DNA backbone expressing a different~     transgene (of which doses up to 7 mg DNA IV/single dose have been administered). Patients~     will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema~     (100%-50%-33%-33%) at a starting intratumoral dose of 0.010 mg/kg of DNA through a dose of~     0.053 mg/kg DNA intratumoral / single dose. Should a single, but not more than two (2), ≥~     Grade 3 Dose Limiting Toxicity (DLT) occur in any cohort, following mandated review (see~     below) an additional two (2) patients will be accrued at that dose (total of six). If more~     than one ≥ Grade 3 toxicity occurs in any cohort, the preceding dose cohort will be expanded~     to six (from four) and if < 2/6 patients experience ≥ Grade 3 toxicity, that dose will be~     the Phase II recommended dose. Should no ≥ Grade 3 toxicity occur in any cohort (other than~     Grade 3 local injection site reaction), an additional two (2) patients will be treated at~     0.053 mg/kg DNA intratumoral / single dose.~   "
118479|NCT01505140|"~     Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other~     nutrients essential to sperm development and function. This randomized controlled trial~     sought to determine if a Western style diet supplemented with walnuts would improve sperm~     quality as a predictor of male fertility.~   "
118480|NCT01505127|"~     The purpose of this study is to confirm the efficacy of triple therapy with TAK-438,~     Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to~     triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive~     patients with scarred gastric or duodenal ulcers.~   "
118481|NCT01505114|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety~     and tolerability of four ARV regimens in preventing HIV infection in men who have sex with~     men who may be at risk of getting HIV infection through sex and women who may be at risk of~     getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc~     (MVC), MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF~     plus FTC. The MVC-containing arms will be compared to TDF/FTC alone and in combination.~   "
118482|NCT01505101|"~     Persons suffering from chronic pain who are treated with long-term opioid therapy are at~     risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term~     use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption.~     Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes,~     and substance use. The investigators hypothesize that relative to a support group control~     condition, participation in a novel mindfulness-oriented cognitive intervention,~     Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and~     decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients~     receiving opioid therapy.~   "
118483|NCT01505088|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis~     with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with~     non-infectious anterior segment uveitis.~   "
118484|NCT01505075|"~     The purpose of this study is to determine the safety and efficacy of a short course of~     radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer~     currently being managed with primary androgen deprivation therapy (PADT).~   "
118485|NCT01505062|"~     To evaluate the safety and tolerability of ascending doses of subretinal injections of~     UshStat in patients with Usher syndrome type 1B.~      To evaluate for possible biological activity of UshStat.~   "
118486|NCT01505049|"~     Vaccines for human papillomavirus (HPV) have been available in the United States since 2006.~     Early studies have shown a high rate of effectiveness of these vaccines, however it is not~     known how long this protection will last. The IMAP study will look at various parts of the~     immune system and potential markers for long lived immune responses to this vaccine.~   "
118487|NCT01505036|"~     SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with~     diabetes.~   "
118488|NCT01505023|"~     The objective of this study was to test the efficacy of a partial meal replacement added~     with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients~     intake in obese Mexican women~   "
118489|NCT01505010|"~     INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control~     group) or usual medical treatment plus renal denervation (intervention). In both groups~     adherence will be monitored both before randomization and during 36 months of follow-up.~   "
118490|NCT01504997|"~     The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph~     node dissection in patients with stage Ia early gastric cancer.~   "
118494|NCT01504945|"~     Patients with a low blood count (anemia) with stable or unstable coronary artery disease~     consistently show worse clinical outcomes. It is unclear whether this association is~     confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions~     or more comorbidities and this would be the reason for the worse outcomes rather than~     anemia. The coronary arteries are a unique vascular bed insofar that across the cardiac~     circulation oxygen extraction is close to maximal at rest. Thus increases in demand can only~     be met by increases in blood flow and hemoglobin concentration since oxygen extraction is~     maximal at rest. It is natural to assume that maximization of oxygen delivery in the setting~     of active coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and~     coronary blood flow is fixed. In fact, in most intensive care units patients with ACS are~     transfused to a HCT of 30%. However, retrospective analysis of trial data showed at best~     mixed results in clinical outcome when patients with ACS were transfused and in fact in some~     studies showed consistently worse outcomes than non-transfused patients. Similar~     disappointing results have recently published in patient who underwent coronary artery~     bypass grafting (CABG).~      This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen~     consumption, cardiac, microcirculatory and endothelial function in patients with active~     coronary artery disease. For this study active coronary artery disease will be defined as~     the patient having undergone within the past 4 days of recruitment either a myocardial~     infarction due to atherothrombosis (AHA type I myocardial infarction) or surgery for~     coronary artery bypass grafting.~      In specific this study will test the hypothesis whether RBC transfusions improves cardiac~     and vascular function in patients with a hematocrit of less than 30% with active coronary~     artery disease.~      Aims of this study are to determine whether RBC transfusion in patients with active coronary~     artery disease and anemia:~        -  increases oxygen delivery to the peripheral tissues.~        -  increases whole-body oxygen consumption.~        -  decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial~          function, and/or increases platelet aggregation~   "
118495|NCT01504932|"~     This pilot clinical trial studies freeze-dried black raspberries in preventing oral cancer~     recurrence in high-risk Appalachian patients previously treated with surgery for oral~     cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. Giving~     freeze-dried black raspberries may prevent oral cancer from forming~   "
118496|NCT01504919|"~     The goal of this research study is to learn if a wellness program can help improve diet and~     physical activity levels and encourage smoking cessation in Latino individuals who are~     overweight.~   "
118497|NCT01504906|"~     The purpose of this study is to assess the effect of Cyclosporine on the blood levels of~     Ticagrelor.~   "
118498|NCT01504893|"~     The purpose of this study is to determine if a protective ventilatory strategy during~     one-lung ventilation (OLV) could reduce postoperative complications after thoracotomies or~     thoracoscopic pulmonary resection.~      Primary endpoint: Evaluation of Acute Lung Injury (ALI) incidence~      Secondary endpoint: postoperative outcome (hospital stay, morbidity, mortality and their~     correlation with preoperative comorbidity and surgery technique.~   "
118499|NCT01504880|"~     The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and~     tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic~     resonance imaging (CMR) as the non-invasive gold standard compared to transthoracic~     echocardiography (TTE) to evaluate measurements of the width of the regurgitation jet (vena~     contracta (VC)) to demonstrate the utility of the VC as a means to objectively evaluate~     atrioventricular valve regurgitation. In addition, feasibility and other quantitative and~     qualitative measures of regurgitation will be compared between CMR and TTE.~        -  Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation~          and VC width with TTE and CMR has a high feasibility rate with acceptable intra and~          inter-observer variability by two independent readers.~        -  Hypothesis 2: There will be positive correlation between the TTE measurement of the VC~          width and quantitative assessment of atrioventricular valve regurgitation by TTE and~          CMR.~        -  Hypothesis 3: There will be a positive correlation between the quantitative~          measurements of atrioventricular valve regurgitation by phase contrast velocity encoded~          CMR with quantitative values as measured by TTE.~        -  Hypothesis 4: There will be a positive correlation between qualitative assessment of~          atrioventricular valve regurgitation by CMR compared to TTE.~   "
118500|NCT01504867|"~     The primary hypothesis was that early aspirin administration will decrease the rate of~     developing acute lung injury during the first 7 days after presentation to the hospital.~   "
118501|NCT01504854|"~     Resveratrol is derived from plants and is found in highest levels in red wine and the skin~     of red grapes. A recent study reported that monthly and weekly consumption of red wine is~     associated with a lower risk of dementia. There is compelling evidence that caloric~     restriction can improve overall health by activating a class of enzymes known as Sirtuins.~     Resveratrol is a substance found in some plants that directly activates sirtuins, mimicking~     the effects of caloric restriction and may affect regulatory pathways of diseases of aging,~     including Alzheimer's disease (AD).~      In this study, people with AD will be given either Resveratrol or placebo for 12 months to~     determine whether daily resveratrol therapy is beneficial in delaying or altering the~     deterioration of memory and daily functioning. Subjects age 50 and above with a diagnosis of~     probable AD may qualify for participation in this study. A small group of 15 participants~     will be asked to take part in a more detailed 24-hour Pharmacokinetic (PK) sub-study that~     will measure resveratrol levels over a 24 hour period.~   "
118502|NCT01504841|"~     Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of~     combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is~     increasing, leading to treatment failure. This study will test the safety, tolerability, and~     dosing levels of etravirine (ETR), a new NNRTI.~   "
118503|NCT01504828|"~     Normal aging is characterized by altered cardiovascular function. Our preliminary data with~     MR imaging and spectroscopy in normal subjects without cardiovascular disease or~     hypertension show that age-related cardiac dysfunction is characterized initially by~     impaired relaxation of the heart (40 - 60 years), and then at > 60 years altered contraction~     and impaired myocardial energetics. For the first time, the investigators will test whether~     the functional and energetic effects of normal aging can be reversed by acutely reducing~     stiffness of peripheral blood vessels using an ACE inhibitor. This will potentially have~     important insights into how normal aging affects the heart, and how potential treatments~     could be used to attenuate this process.~   "
118504|NCT01504815|"~     This Phase III trial aims to:~      Explore the impact of pre-treatment information and radiation dose redistribution on~     locoregional control in patients with locally advanced SCCHN.~      The dose to the primary tumor with margins, based upon PET and CT information, will be~     inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards~     the edges of the irradiated area.~      To determine the toxicity of combined modality treatment (cisplatin) with standard dose~     distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous~     radiation dose distribution.~   "
119084|NCT01497210|"~     The primary objective of this study is to evaluate the safety and preliminary performance of~     EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.~   "
118505|NCT01504802|"~     It is now widespread practice to treat children with short stature with growth hormone.~     However, how an individual child will respond to growth hormone treatment is unpredictable~     and highly variable. Some children will not respond to growth hormone treatment at all.~     Currently, the only way to determine how well growth hormone therapy is working is to wait~     until they have been treated for six months and to compare the pre-treatment growth velocity~     with the growth velocity on treatment. It would be helpful to have a blood test that could~     be done shortly after starting growth hormone that could predict whether how well a child is~     responding to treatment. Such a blood test would allow endocrinologists to adjust the growth~     hormone dose (or possibly stop it altogether, if it is not working) long before the six~     months it currently takes.~      C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP)~     are proteins that play a critical role in regulating growth. The investigators have~     previously shown that blood levels of these proteins increase in children being treated with~     growth hormone. The investigators believe that a blood test for these proteins will be~     useful in predicting a child's response to growth hormone treatment.~      The purpose of this study is to determine when after starting growth hormone, the blood~     levels of CNP and NTproCNP start to increase.~   "
118506|NCT01504789|"~     The goal of this research study is to test an exercise program that is designed for Hispanic~     breast cancer survivors. Researchers want to learn the most effective strategies for~     promoting exercise.~   "
118507|NCT01504776|"~     The purpose of this study is to determine the safety and clinical efficacy of the~     combination of panobinostat plus bortezomib.~   "
118508|NCT01504763|"~     The purpose of this study was to assess the feasibility and effect of chair massage provided~     during working hours for nurses in an inpatient psychiatric and an outpatient pain~     rehabilitation unit and on the nurses stress related symptoms.~   "
118509|NCT01504750|"~     Rationale:~      Many study reports described benefits of natural sunlight. It is believed that artificial~     light can achieve similar benefits as sunlight and can be used to compensate for the lack of~     sunlight, for instance in north-facing hospital rooms or during wintertime.~      The most plausible paths mediating the effects of light are:~        -  the biological effect of light, relating to circadian biology and the~          sleep/wake-rhythm;~        -  the emotional/psychological effects of light, relating to mood/stress and the~          antidepressant action of light .~      Objective:~      The project aims to measure, evaluate and quantify the beneficial effects of a dynamic~     daylight & atmosphere experience in patient rooms for cardiovascular patients during the~     dark months of the year.~      Study design:~      The study involves an experiment in which psychological, emotional and clinical parameters~     of patients in hospital rooms with standard light situation are compared with those of~     patients in rooms with a dynamic daylight & atmosphere experience.~      Study population:~      The population includes cardiovascular patients who reside in the general cardiology~     department of the Maastricht University Hospital (18 patient beds) with an intended minimum~     length of stay of 3 days, who have given written consent.~      Intervention:~      Half of the patient rooms on the ward are equipped with special luminaires. In the ceiling,~     luminaires are installed that offer the basic lighting in the patient room that will~     automatically and gradually change in light level (100-300 lux) and color temperature~     (3000-4000 K). This so called daily rhythm light meets the EN12464-1 standard for patient~     rooms in hospitals. The same luminaires in the ceiling will also offer the light boost by~     bringing the illuminance to a level of maximal 2000 lux and 7000 K, during a period of two~     hours in the morning. Besides the ceiling luminaires, a low intensity color cove as well as~     some white LED spots are added to create a pleasant ambience in the patient room~      Main study parameters/endpoints:~      The primary study measures are length of stay and quality of recovery expressed by~     physiological, emotional and clinical parameters. Also the effect on patient satisfaction is~     determined using pre and post assessments.~   "
118510|NCT01504737|"~     SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due~     to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on~     postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of~     valve diseases is presented without considering the differences in pathophysiology and the~     training regimes are not clearly described.~      PURPOSE, AIMS & HYPOTHESIS The investigators purpose is to evaluate whether a supervised~     cardiac rehabilitation program improves the objective physical capacity and quality of life~     (QoL) of patients after AVR due to AS, and compare this to patients training by their own.~     The investigators hypothesize that supervised exercise training may be a more efficient way~     of rehabilitating these patients.~      DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised~     exercise training 3 times per week to home-based training based upon public health~     recommendations of minimum level of physical activity.~      SIGNIFICANCE & IMPLEMENTATION Positive results would support that an organized program of~     exercise training improves physical capacity and QoL in AS patients following AVR with~     potential benefit for both patients and society.~   "
118511|NCT01504724|"~     This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before~     panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and~     retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without~     macular edema.~   "
118512|NCT01504711|"~     This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in~     patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs,~     such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in~     patients treated with chemotherapy.~   "
118513|NCT01504698|"~     The purpose of this study is to determine the effect of manipulative treatment of children~     with neck and back pain. Because manipulation is the most frequently used treatment of~     musculoskeletal complaints in children, and an increasing number of Danish children see a~     chiropractor, it appears obvious to start the search for evidence by examining the effect of~     this treatment.~   "
118514|NCT01504685|"~     The purpose of the study is comparatively analyze the advantages and disadvantages of banded~     versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).~      The outcome variables of the general study included morbidity, maximal weight loss, and late~     weight regain.~   "
118515|NCT01504672|"~     The aim of this randomized controlled study is to investigate if medication reviews~     performed by a clinical pharmacist as part of a ward team can reduce drug related problems~     and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and~     cognitive failure.~      Four hundred and sixty patients will be recruited and randomized to control (usual care) and~     intervention group (enhanced service in which a pharmacist is part of the health care team).~      Six months after the last patient of the 460 has been discharged the study will be closed.~     Data about the number of readmissions and visits to the emergency room will be collected~     during the six-month follow-up and also, the costs associated with each visit or admission.~     Time until institutionalization will be compared between intervention group and control~     group.~   "
119873|NCT01486862|"~     This trial is conducted in North America. The aim of this trial is to investigate the~     efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving~     glycaemic targets on OADs (oral anti-diabetic drugs).~   "
118516|NCT01504659|"~     The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine~     hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar~     disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are~     most resistant to traditional treatments and suffer repeated hospitalizations. Primary~     symptoms include fearfulness, aggression secondary to threat, mood and/or arousal~     instability, and psychosis. In addition to evaluation of efficacy and safety, the~     investigators will also analyze whether therapeutic response depends upon the degree to~     which the subject fits the FOH phenotype.~   "
118517|NCT01504646|"~     The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation~     on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in~     individuals with asthma. The investigators hypothesize that Lyprinol® supplementation,~     compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced~     bronchoconstriction in asthmatic individuals.~   "
118518|NCT01504633|"~     Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA),~     especially docosahexanoic acid (DHA), supplementation on cognitive function in human using~     randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent.~     It has been suggested that the effect may be subtle, which is currently difficult to detect,~     but could be significant, or there may be individual variation which mediate the effect.~      Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect~     of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia.~     Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and~     iron (as iron supplement) in altering gene expressions, and (2) to assess the mediating~     effect of genes involved in fatty acid and iron metabolism in improving serum LCPUFA,~     alpha-linolenic acids (ALA), DHA and cognitive function.~      Study design and study population: The study is a double-blind randomized controlled trial~     with children aged less than 24 months (window of opportunity). The study area is in East~     Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including~     iron and presumably LCPUFA, is not optimal.~      Intervention: The study is an intervention study, consisting of four groups: DHA, iron,~     DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing~     100mg/d DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24~     weeks. Before and after the intervention child cognition (as Bayley Mental Developmental~     Index or MDI score), serum PUFA level, iron status (haemoglobin, transferrin receptor,~     ferritin), inflammation status (CRP, AGP), gene expression profiles, and potential~     confounders of child cognition such as lengt-for-age, weight-for-length, and weight-for-age~     Z-scores, stimulation/home environment, maternal characteristics will be collected.~      Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental~     Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes~     will be serum PUFA level, iron status (haemoglobin, TfR, ferritin).~      Nature and extent of the burden and risks benefit and group relatedness:~      Subjects, who will be included into the study will invest 14 hours. The consumption of iron~     is not associated with any increased risk of iron overload both for infectious (including~     malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US~     Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of~     5 mL will be drawn at baseline and endline. During screening, children with severe anaemia~     (Hb<70g/L) will be excluded from the study and referred to the local public health center~     for further treatment.~   "
118519|NCT01504620|"~     The goal of this single-center, comparative, open label, in-vitro diagnostic device~     performance evaluation was to investigate the performance of two sanofi-aventis BGMSs~     (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence~     (Helios).~   "
118520|NCT01504607|"~     Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is~     reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs~     following cataract surgery. However, no data is available regarding endothelial changes~     after cataract surgery with IOL implantation in pediatric eyes.~      The aim of this study is to prospectively observe changes in endothelial cell density,~     coefficient of variation and hexagonality following cataract surgery with IOL implantation~     in pediatric eyes.~   "
118521|NCT01504594|"~     The purpose of this study is to determine whether an autologous stem cell infusion through~     catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.~      Process:~        1. Primary Evaluation~             -  Clinical History~             -  Echocardiogram to evaluate ejection fraction and other parameters~        2. Signing of Informed Consent and clearing doubts~        3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony~          Stimulating Factor) applied subcutaneously~        4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by~          hematologists through posterior iliac crests(amount calculated at 8cc/kg, without~          exceeding 150ml).~        5. Recovery room with family members while the cells are being processed in the Hematology~          Laboratory.~        6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation~          room, which is equipped for cardiac catheterization, so that cardiologists infuse the~          stem cells through the femoral artery into the coronary arteries which irrigate the~          heart´s muscle fibers.~        7. Patient goes back to the recovery area until the anesthesia effect is gone and can~          tolerate oral liquids.~        8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.~   "
118522|NCT01504581|"~     Study design:~      This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4~     groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of~     HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a~     single dose of a currently marketed PEG-interferon.~   "
118523|NCT01504568|"~     The purpose of the research is to perform a quality assurance evaluation using randomized~     prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital~     blowout fracture in patients treated versus not treated with prophylactic antibiotics.~      The investigators goal is to show the use of prophylactic antibiotics in orbital blowout~     fractures does not significantly decrease the rate of orbital cellulitis and is thus not~     indicated.~   "
118524|NCT01504555|"~     Background: The evaluation for hypercortisolism includes an overnight 1mg dexamethasone~     (DXM) suppression test. An important shortcoming is the diagnostic specificity of only 80%,~     which is likely due to inter-individual differences in gut absorption or metabolism of DXM.~      Study hypothesis: The investigators hypothesize that serum-DXM measurements will increase~     the diagnostic accuracy of the overnight DXM-test in the work-up of hypercortisolism.~      Aims: The primary aim of this prospective study is to evaluate if serum-DXM measured~     simultaneously with serum-cortisol in morning samples could increase the diagnostic accuracy~     this diagnostic test. There are several secondary aims. One is to estimate the prevalence~     and causes of unusual DXM absorption or metabolism. The investigators will also evaluate the~     feasibility and diagnostic accuracy of salivary DXM. Moreover, the diagnostic accuracy of~     midnight salivary cortisol and cortisone, and urinary cortisol, will be evaluated and~     compared.~      Design: Levels of DXM in morning serum following an overnight DXM-test will be analyzed in~     patients under evaluation for hypercortisolism (including incidentalomas). A cut-off level~     to identify inadequate DXM concentrations in serum to suppress endogenous cortisol~     production will be established based on the negative tests. This cut-off level will then be~     applied in a retrospective analysis of the diagnostic accuracy of DXM-tests. This~     prospective study has a blinded design as the DXM measurements are disclosed after the end~     of the trial.~   "
118525|NCT01504542|"~     This study will enroll patients with locally advanced or metastatic non-EGFR mutated~     Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more~     than two prior approved treatment regimens. Patients will be randomized to receive one of~     two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and~     patients will also receive erlotinib 150mg taken orally once daily for the duration of the~     trial. The study will examine the immune effects, safety and efficacy of two different doses~     of HS110 vaccine in combination with erlotinib versus erlotinib alone.~   "
118526|NCT01504529|"~     This is an observational, non-interventional and retrospective study in patients with~     advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians~     according to usual clinical practice in Spain.~      The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients~     who have been treated with Rotigotine for at least 6 months.~   "
118527|NCT01504516|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single~     dose, crossover, oral bioequivalence study.~   "
118528|NCT01504503|"~     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single~     dose, crossover, oral bioequivalence study.~   "
118529|NCT01504490|"~     This study is for patients with advanced solid tumors. The purpose of this study is to test~     the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in~     patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer~     cells, including stopping cancer cells from growing and dividing, and causing the cancer~     cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs~     together may have an even greater effect against cancer cells, hopefully, increasing the~     killing of cancer cells.~      CS-7017 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene~     is an anti-cancer agent that has been approved by the FDA for patients with a specific type~     of cancer, cutaneous T-cell lymphoma.~      This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene,~     has on cancer. This research is being done because it is not known if CS-7017 is safe to be~     given with Bexarotene.~   "
118530|NCT01504477|"~     This study is for patients with colon cancer that cannot be fully removed by surgery and has~     come back after or not responded to standard chemotherapy treatment.~      Subjects will be enrolled to either the first part of the study (Phase I) or the second part~     of the study (Phase II). Phase I will be completed before Phase II will start. The purpose~     of the Phase I part is to find the highest dose of bortezomib that can be given with~     panitumumab without causing severe side effects. The purpose of the Phase II part is to test~     the effects the two drugs have on subjects with colorectal cancer.~      Panitumumab is a drug that targets a protein important for the growth of cancer cells known~     as EGFR. By blocking the activity of the protein, panitumumab can block cancer cell growth~     and even lead to their death. Panitumumab is given intravenously once every two weeks.~     Panitumumab is approved by the FDA for patients with colorectal cancer.~      Bortezomib is a drug that targets a part of the cancer cell known as the proteosome. By~     inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their~     death. Bortezomib is given intravenously, once a week, 3 out of every 4 weeks. Bortezomib is~     not FDA approved for the treatment of colorectal cancer.~      As part of this study the investigators will be taking biopsies of patients' tumors before~     any treatment, after starting with the panitumumab alone, and after receiving both the~     panitumumab and bortezomib. The investigators want to investigate what markers inside tumors~     may relate to how well these two medications work. These biopsies are required as part of~     the study.~   "
118531|NCT01504464|"~     Osteoarthritis of the knee is one of the most common causes of disability among elderly. As~     the disease progresses the cartilage become frustrated, surrounding bone react to become~     thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in~     signal density. Patients are treated initially by pain management. In patients who don't~     response to first line treatment invasive treatment like total knee replacement is done. The~     investigators designed this clinical study with the aim of evaluating therapeutic effects of~     intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with~     severe knee osteoarthritis.~   "
118532|NCT01504451|"~     This study is designed to compare three different techniques in ablation of paroxysmal~     atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation~     system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation~     system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that~     surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.~   "
118533|NCT01504438|"~     This is a randomized study to prospectively compare and evaluate the functional outcome and~     patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either~     the STAR or Salto-Talaris prothesis.~   "
118534|NCT01504425|"~     The investigators aim to define the concept of difficult colonic polypectomy and investigate~     whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic~     submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip~     placement, submucosal injection) and operator experience have an impact on polypectomy~     outcomes and complication rate.~   "
118535|NCT01504412|"~     The purpose of this study is to investigate the effectiveness and safety of DS-5565,~     compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.~   "
118536|NCT01504399|"~     This is a prospective, multi-center observational study designed to address patient-reported~     nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary~     tumors. The primary objective of this study is to determine the difference in nasal outcomes~     by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic~     surgical technique and those treated with microscopic surgical technique. Patients will be~     given the ASK Nasal survey to assess their nasal functioning and overall health before their~     surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.~   "
118537|NCT01504386|"~     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane~     (TAP) block as a part of a multimodal postoperative pain management after robot-assisted~     laparoscopic hysterecomy.~   "
118546|NCT01504256|"~     The purpose of this study is to determine the efficacy of catumaxomab by determination of~     the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment~     with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant~     chemotherapy.~   "
118547|NCT01504243|"~     CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively~     expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as~     a critical mediator of inflammatory response in the context of sepsis. This study was~     designed to investigate whether CD163 genomic variations were associated with the prognosis~     of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR~     sequencing. When analyzing the results of sequencing, we found five gene polymorphisms~     located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap~     database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two~     polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last~     two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common~     polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with~     severe sepsis and in 200 healthy control subjects. This study was explored that whether or~     not polymorphisms detected within the CD163 gene may play a major role in the predisposition~     to prognosis of sepsis in a Chinese Han cohort.~   "
118538|NCT01504373|"~     Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical~     ventilation. This mode of ventilation is currently in routine use in adult, pediatric and~     neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle~     used during inspiration, is measured. The ventilator triggers (synchronizes patient effort)~     and applies proportional assistance based on measured electrical activity of the diaphragm~     (Edi). This electrical activity is measured through a feeding tube that also has a~     multiple-array esophageal electrode in it. This mode of ventilation has been proven to be~     equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath~     control offered by NAVA may not only trigger faster and synchronize better, but provide the~     support deemed appropriate by the central nervous center on demand. Traditionally in the~     intensive care unit (ICU), pressure support is applied to subject breathing spontaneously.~     Pressure is set to achieve a given tidal volume. The influence of changing lung compliance~     not only from the lung disease itself, but the interactions of the respiratory muscles can~     drastically change minute ventilation and contribute to hyper- or hypoventilation. These~     changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or~     oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed~     the central nervous system to control the ventilator. NAVA may allow us to couple the~     central nervous system (neuro-coupling) with the ventilator to provide real-time~     proportional assistance, reduce work of breathing and apply physiologic breathing patterns.~   "
118539|NCT01504360|"~     Development of sarcoma within or adjacent to radiation field is a well known event of poor~     prognosis and unknown risk factors. Advanced techniques of radiation therapy including~     intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new~     modalities of radiation delivery that could be responsible for developing these induced~     tumors. There is little data on molecular biology of radiation induced sarcoma even if some~     tools are still available to characterize these types of tumors aiming to compare their~     profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry,~     currently called CONTICANET data base in the framework of EORTC, represents the backbone of~     the project. The next step should follow two axes, a clinical one based on the dosimetric~     analysis of the characteristics of delivered radiation therapy and the second one based on a~     molecular characterization of the sarcomas developed in irradiated field.The data base will~     be updated and organized through the CONTICANET network and the radiation oncologists~     involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical~     data and the parameters describing the initial treatment will be registered using the~     methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The~     most recent data will be extracted in DICOM format for intercomparison in a dedicated~     software.A centralized review of pathological specimens is planned to validate the correct~     classification of the tumors inside the current staging system developed for soft tissue~     sarcoma.~   "
118540|NCT01504347|"~     Section 1:~      The purpose of the study is to obtain safety and immunogenicity data of different dose~     levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and~     without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall~     provide the basis for dose/formulation selection for Section 2 of the study.~      Section 2:~      An additional purpose of the study is to evaluate the safety and immunogenicity of the~     optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of~     seronegative and seropositive healthy subjects aged 18 to 70 years.~   "
118541|NCT01504334|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease~     characterized by fibrosis of the supporting framework (interstitium) of the lungs. By~     definition, the term is used only when the cause of the pulmonary fibrosis is unknown~     (idiopathic). Microscopically, lung tissue from patients shows a characteristic set of~     histologic/pathologic features known as usual interstitial pneumonia (UIP). UIP is therefore~     the pathologic counterpart of IPF.Idiopathic pulmonary fibrosis is characterized by~     radiographically evident interstitial infiltrates predominantly affecting the lung bases and~     by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly~     shown to prolong survival. The current strict definition of idiopathic pulmonary fibrosis~     provides a new focus for basic and clinical research that will improve insight into the~     pathogenesis of this disorder and stimulate the development of novel therapies.~      Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro~     systems and animal models of pulmonary fibrosis, although its precise mechanism of action~     remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated~     proteins and cytokines, and the increased biosynthesis and accumulation of extracellular~     matrix in response to cytokines such as transforming growth factor-β. It is also shown to~     slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth~     factor and platelet-derived growth factor.~      Pirfenidone has not been widely approved for clinical use in China, in this study, safety~     and efficacy were evaluated to see if pirfenidone has a significant advantage over placebo~     in terms of improving lung function and life quality etc. (see primary and secondary~     criteria) or slows down the deterioration of lung function in Chinese subjects diagnosed~     with IPF.~   "
118542|NCT01504321|"~     Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and~     has been associated with a number of metabolic abnormalities.~      Given the strong correlation between metabolic abnormalities and increased sympathetic~     activity, we hypothesise that reducing this activity using medication (moxonidine) can help~     improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary~     syndrome.~   "
118543|NCT01504308|"~     The purpose of this clinical study is to determine whether treatment with the Philips~     Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is~     effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).~   "
118544|NCT01504295|"~     It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly~     beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in~     Europe for acute and chronic alcohol intoxication but has never been tested in the US.~     Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX~     reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol~     consumption and improve liver function is confirmed by a rigorous study design, then MTDX~     might represent a truly innovative pharmacotherapy for AD, given the potential to be used~     for AD individuals with ALD. However until this proposal, MTDX has never been investigated~     as a treatment for AD able to reduce both alcohol consumption and improve alcohol-related~     liver damage via a double-blind placebo-controlled study. This project therefore proposes to~     conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled,~     between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.~   "
118545|NCT01504282|"~     To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during~     photorefractive keratectomy (PRK) for patients with low myopia.~   "
118548|NCT01504230|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury and even mortality. Identifying the~     factors related to falls occur within this population is essential for the development of~     effective regimes for fall prevention. The long-term objectives of this work are to~     ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis~     and to provide a basis for developing fall prevention programs. The entire body's center of~     mass (CoM) is a critical indicator for balance control and the coordination among joints and~     muscles to control the CoM is still unclear. The aim1 of this study is to develop~     biomechanical models that control the entire body's center of mass (CoM) during upright~     quiet stance in seniors with osteoporosis. The aim2 of this study is to identify the~     mechanism to control the entire body's CoM after receiving a balance perturbation in seniors~     with osteoporosis. The findings of this research can provide needed information regarding~     the processes of balance control in this vulnerable osteoporosis population, and has the~     potential to be applied to individuals with other neuromuscular and orthopedic deficits.~   "
118549|NCT01504217|"~     Falling among older adults is a major public health concern. In fact, falls are the leading~     cause of accidental death in older adults both in Taiwan and in the United States. In order~     to provide effective preventative strategies, the investigators must understand the~     mechanisms that cause older adults to fall. Thus, the investigators research aim for three~     objectives: (1) using biomechanical model to identify the deficits in neuromuscular control~     for older adults (2) to apply research findings to the development of new clinical methods~     for assessing and recovering balance control in older adults, and (3) to predict fall risks~     in 1-2 year for older adults from the research findings.~   "
118550|NCT01504204|"~     The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel~     in patients with mild to moderate acne who receive a medication sample and instructions on~     proper application with their stock size medication tube versus patients who receive only~     the stock size medication tube.~   "
118551|NCT01504191|"~     The overall aim and primary objective is to evaluate the effects on level of depression and~     anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a~     myocardial infarction (MI).~   "
118552|NCT01504178|"~     Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations~     that could be, in part, due to a central modification of nociception mechanisms. Previous~     studies have shown that pain perception was altered in Parkinson's disease (subjective and~     objective pain thresholds and pain-induced cerebral activity) and that administration of~     L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in~     dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain~     threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be~     involved in pain alteration in PD.~      To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine~     (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that~     duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients~     with PD.~      36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine~     increase the pain perception level compare to the placebo. This increase would be the same~     than those observed with L-Dopa.~   "
118553|NCT01504165|"~     This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose,~     Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects~     with different grades of renal impairment as compared to subjects with normal renal~     function.~   "
118554|NCT01504152|"~     The purpose of this study is to survey patients who underwent hematopoietic stem cell~     transplant (HSCT) to assess if they have traveled or not internationally after transplant.~     This information will help to improve the understanding of the needs for travel health~     strategies and interventions to provide healthy and safe travel to HSCT patients. The~     findings of this survey will also be used to develop travel health related interventions for~     patients living with cancer as well.~   "
118555|NCT01504139|"~     The purpose of this study is to investigate levels of progesterone in the luteal phase after~     various stimulations in the follicular phase and treatment with GnRH antagonist protocol~     followed by GnRHagonist as induction of ovulation.~   "
118556|NCT01504126|"~     The goal of this clinical research study is to learn if it is feasible to give a~     beta-blocker such as Inderal (propranolol hydrochloride) with standard chemotherapy~     (paclitaxel and carboplatin or possibly docetaxel) to treat ovarian cancer. The safety of~     propranolol hydrochloride will also be studied.~      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.~     Researchers want to learn if this might also boost the immune system, allowing the~     chemotherapy to be more effective.~      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.~      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell~     division, which may cause the cells to die.~   "
118557|NCT01504113|"~     Background:~      Psoriasis is a chronic, immunologically-mediated, inflammatory skin disease and targeted~     therapies e.g. tumor necrosis factor (TNF)-α and TH-17 antagonists have become increasing~     important agents in the management of psoriasis. TNF, interleukin-17 (IL-17) and TH-17 play~     major roles in defense against infection. Large-scaled clinical trials and post-marking~     surveillance had shown these agents may increase susceptibility to infections. Most studies~     evaluate the reactivation of tuberculosis but the influence of targeted therapies on the~     viral infection has not been extensively investigated.~      TNF-α has been shown to contribute to the killing of cytomegalovirus (CMV)- and human~     papillomaviruses (HPV)-infected cells. Additionally, recent studies have shown a high~     prevalence of HPV DNA in psoriatic skin and increased HPV5 antibodies in patients with~     psoriasis. The prevalence of HPV in the skin was also affected by therapeutic modalities,~     such as psoralen-ultraviolet A (PUVA). Several case reports in which CMV, Epstein-Barr virus~     (EBV) and HPV infection complicated therapy with TNF-α antagonists have been reported.~     However, the study investigated the effect of TNF-α antagonists and other biologics on~     reactivation of latent viruses is limited. Only two studies investigated the short-term~     effect of infliximab on reaction of herpesviruses in patients of rheumatoid arthritis and~     Crohn's disease. The high prevalence of combination use of immunosuppressants, such as~     methotrexate alongside with TNF-α antagonists in these patients is different from patients~     with psoriasis. Additionally, various bacterium and fungi, such as Staphylococcus aureus,~     Malassezia are associated with provocation and/or exacerbation of psoriasis and recent~     studies had shown IL-17 is essential for the immune response to common fungus Candida~     albicans.~      Aim:~      The aim of this study is to prospectively investigate the effect of target therapies (TNF-α,~     TH-17 antagonist, IL-17 antagonists, tofacitinib and apremilast) on the activation of~     viruses, including CMV, EBV and HPV and the impact of biologics on the prevalence of surface~     colonization of microorganism, including HPV, bacteria and fungi, in patients with~     psoriasis.~      Methods and procedures:~      Our project consists of two related study. The first (Study 1), a prospective observational~     study, included patients with psoriasis who are going to undergo biologics therapy, the~     viral loads of CMV and EBV, HPV DNA detection in eyebrow hairs and skin scales, and~     bacterial, fungal cultures from skin scales were performed before the initiation, 12 and 24~     weeks after initiation of the target therapies, 12 weeks after discontinuation of target~     therapies. This part of our project is to investigate the dynamic effect of biologics on the~     microorganisms in patients with psoriasis. The second part (Study 2), a case control study,~     recruits psoriasis patients who have started target therapies, they receive the sampling of~     blood, eyebrow hairs and skin scales for CMV, EBV and HPV investigations when they are~     enrolled. Control group compromised of age-and disease severity-matched psoriasis patients~     who are not treating with target therapies or other systemic antipsoriatic agents.~     Comparison of the prevalence of latent virus, virus reactivation, bacteria and fungi skin~     colonization between psoriasis patients who are treating with and without target therapies~     is performed. The aim of study 2 was to assess any difference of the status of latent virus~     or microorganism colonization in skins between psoriasis patients treated with and without~     target therapies.~   "
118558|NCT01504100|"~     Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The~     efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been~     reported good outcomes in most patients. However, some studies reported less effective in~     patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q~     angle. The investigators hypothesized that femoral internal rotation is a negative factor to~     the patellar taping. The investigators enroll consecutive 100 patients with anterior knee~     pain and radiographic evidence of patellar subluxation. The investigators determine femoral~     rotation via physical examination. The visual analogue scale was evaluate to compare the~     result between the those with and without femoral internal rotation.~   "
118572|NCT01503918|"~     The purpose of this study is to determine whether reactivation of latent cytomegalovirus~     infection in critically ill patients looked after in the intensive care unit can be~     successfully and safely prevented using antiviral agents. Comparison is made between~     standard care, and treatment with one of two different antiviral regimens:~     valaciclovir/aciclovir, which has a favourable side effect profile but requires high dosage~     to be effective, and valganciclovir/ganciclovir, which has more side effects, but has been~     demonstrated to be effective in low dosage.~      The primary hypothesis is that cytomegalovirus reactivation can be effectively suppressed~     with antiviral prophylaxis.~   "
118559|NCT01504087|"~     Venous thromboembolism (VTE) is one of the major public health problems in Western country.~     More than 100,000 Americans die each year from VTE. VTE is also a common complication of~     critical illness,1-2 and probably related to poor outcome in this patient group. Although~     there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in~     medical ICU3, they are overlooked in our daily practice frequently in our country. There are~     many reasons for our common practice, including inadequate knowledge for the ICU physicians,~     more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern)~     country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed~     in certain high risk patients are not unknown. Besides, if there is a difference in the VTE~     rate between western and eastern patients, what is the underlying mechanism? The major~     objective of this application is to answer the first part of the problem, i.e. to delineate~     the scope of this problem.~      The specific aims of this application are as follows:~        -  prevalence of venous thromboembolism in ICU in Taiwan~        -  specific risk in subgroups of ICU patients~        -  prevalence and risk factors for silent pulmonary embolism~   "
118560|NCT01504074|"~     Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome~      Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery~     will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance,~     contrast sensitivity and microperimetry in a fixed time schedule~   "
118561|NCT01504061|"~     This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of~     Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.~   "
118562|NCT01504048|"~     The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye~     spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due~     to chronic watery diarrhea.~   "
118563|NCT01504035|"~     The goal of this study was to test the efficacy of local analgesic (lidocaine) loaded~     hemostatic putty in reducing donor site pain following the harvest of pelvic bone grafts. In~     14 patients undergoing harvest of a pelvic bone graft during foot surgery, the bone defect~     at the pelvis was either filled with a lidocaine loaded hemostatic putty (Orthostat-L) or~     the same putty without lidocaine (Orthostat, currently marketed as Hemabsorb).~     Postoperatively, foot pain was eliminated with a peripheral nerve block, while pelvis pain~     was quantified with two commonly used pain rating scales (VAS and Wong Baker). Blood samples~     were collected at regular time intervals to measure lidocaine levels. Patients which~     received the lidocaine loaded putty experienced significantly less pain during the first 12~     hours after surgery as compared to those patients who received the lidocaine deficient~     putty. Blood lidocaine levels always stayed below the toxic threshold.~   "
118564|NCT01504022|"~     The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of~     self-measuring of the blood pressure at home and the use of a pro-active web-based feedback~     system on the blood pressure, number of antihypertensive drugs used, and surrogate~     cardiovascular markers during a 12 month period will be investigated.~   "
118565|NCT01504009|"~     Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of~     muscle strength and functional abilities during their illness. In healthy people, regular~     exercise is the best way to maintain or improve muscle strength, endurance and general~     health status and thereby maintain functioning abilities. Previously, patients with~     neuromuscular diseases were advised to avoid any kind of physical exercise. However, lately~     a number of studies have evaluated the effect of training in patients with neuromuscular~     diseases, and positive effects on the functional abilities have been found. Based on these~     findings we want to investigate the mechanisms leading to development of muscle atrophy and~     loss of functional abilities, and to explore the opportunities of reducing muscle wasting~     and thereby improve the course of the disease development through strength training.~      The main objective is to investigate the effects of strength training on slowing disease~     progression and reduce the decline in muscle strength and function in patients with~     amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies~     of biological processes in muscle tissue in order to unveil mechanisms leading to muscle~     atrophy, and to examine effects of a strength training program. The goal is to be able to~     incorporate strength training in the treatment program of these patients in order to~     maintain muscle strength and function in the individual for as long as possible.~      Minimum 10 patients with the disease are included in the study. Through a 12 week period the~     patients will participate in strength training 2-3 times per week. Muscles biopsies will be~     taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning~     of training and (iii) after 12 weeks of strength training. Patients will function as their~     own controls. Blood samples will be collected simultaneously in order to follow the~     development of the strength training. Furthermore, participants will be assessed through at~     number of functional tests and questionnaires evaluating their strength, balance and social/~     psychological status.~      Subjects are recruited through their association with Odense University Hospital. In the~     present study, the participants become part of a social network, while participating in~     organized training sessions, and thus have a possibility to make contact with other ALS~     patients in the same situation as themselves.~   "
118566|NCT01503996|"~     The purpose of this study is to examine if a chronic dehydration is a risk factor for the~     developement or progression of some forms of glaucoma.~   "
118567|NCT01503983|"~     The objective of the study is assess the efficacy and safety of Trastuzumab in combination~     with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or~     metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.~   "
118568|NCT01503970|"~     The purpose of this study is to assess safety and efficacy of autologous chondrocyte~     implantation delivered arthroscopically into chondral lesions of the knee using clinical,~     biochemical, and MRI outcomes.~   "
118569|NCT01503957|"~     The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms~     of persistent allergic rhinitis when applied before allergen challenge.~   "
118570|NCT01503944|"~     The purpose of this study is to evaluate the ability to identify individuals with~     dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia~     with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from~     Alzheimer's disease (AD) and control subjects.~   "
118571|NCT01503931|"~     The mesolimbic dopaminergic reward system is a key structure underlying addictive behaviour~     in alcohol addiction and is under control of prefrontal glutamatergic neurotransmission. The~     aim of the present multicenter-study in Berlin, Bonn and Mannheim is to use functional~     magnetic resonance imaging (fMRI) in alcohol addiction for endophenotyping in order to study~     the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes,~     for addiction. The investigators will use a temporal discounting and a cue reactivity~     paradigm in alcoholics and healthy controls in order to 1) test the impact of genetic~     variation on activation of the mesolimbic system in these populations and to 2) to test~     their predictive effects for treatment outcome in alcoholics. The subproject will thus~     bridge animal research on genetically determined cue reactivity and human studies in~     alcoholics. Furthermore, the investigators will link these results to the measurement of~     glutamate and glutamine with magnetic resonance spectroscopy (MRS) in subproject SP14.~   "
118573|NCT01503905|"~     The current study is a multicentre, randomized, open (unblended), prospective clinical trial~     which is sponsored by the researchers. The trial is designed to compare the effectiveness~     between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as~     neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to~     compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant~     chemotherapies. The investigators will randomly assign 600 premenopausal female patients~     with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four~     cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of~     neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy.~     Patients will undergo modified radical mastectomy or breast-conserving surgery after four~     cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two~     cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the~     NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is~     to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel,~     epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate,~     progression-free survival (PFS) and overall survival (OS)). The secondary aim is to~     correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.~   "
118574|NCT01503892|"~     This study focuses on the use of Metanx® as the sole treatment for improving and reversing~     nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal~     study groups enrolled in this randomized double blinded study. The minimum sample size of~     enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum~     number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or~     patients who have been diagnosed with diabetes type II for less than five years are included~     in this study. The control group will receive placebo pill twice daily versus the treatment~     group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal~     nerve fiber densities obtained by skin biopsies taken at the beginning of the study before~     any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of~     twelve months to re-biopsy. In addition each group will answer three sets of questionnaires~     relating to their peripheral neuropathy at initial, three months, twelve month visitations.~     If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve~     biopsies will show an increase in intraepidermal nerve fiber density and an improvement in~     the subjective score versus the placebo group.~   "
118575|NCT01503879|"~     Mechanical ventilation is a therapeutic method used in order to keep gas exchange adequate~     to cell metabolism in patients with acute respiratory failure. It is currently proved that,~     although on one hand the use of this method keeps gas exchange, on the other hand it~     promotes and supports pulmonary inflammatory processes (VILI). A recent study about the~     effect of positive end-expiratory pressure (PEEP) on DLCO (diffusing capacity of the lung~     for carbon monoxide) in patients undergoing invasive mechanical ventilation has proved that~     patients without any evident pulmonary disease (negative medical history, negative chest~     clinical examination, normal chest X-ray radiography and normal arterial oxygen tension~     [PaO2]) after 24 hours of invasive mechanical ventilation show a significant worsening of~     pulmonary gas exchange properties. The authors have supposed that this worsening may be~     caused by an early alteration of alveolar-capillary membrane caused by mechanical~     ventilation itself. This hypothesis finds support in some studies carried out on animal~     models which founds that mechanical ventilation, even when low tidal volumes (Vt) are set~     for a few hours, is able to induce lung injury (as shown by histologic findings). The most~     sensitive and specific tools the investigators can currently rely on for the study of~     alveolar-capillary membrane are the measurement of diffusing capacity of the lung for carbon~     monoxide (DLCO) and the evaluation of plasmatic levels of pulmonary surfactant protein B~     (SPB). DLCO is a standard, widely diffused technique for the evaluation of functional~     alterations of alveolar-capillary membrane and it is currently available also for patients~     undergoing invasive mechanical ventilation. SBP is produced by type II pneumocytes in the~     alveoli. An increase of its plasmatic levels is correlated to a decay of pulmonary gas~     exchange; SPB thus can be considered an alveolar-capillary membrane anatomical damage~     marker.~      The primary end-point of this study is to evaluate the changes of anatomical (SPB) and~     functional (DLCO) features of alveolar-capillary membrane between the spontaneous breathing~     and mechanical ventilation as well as the progressive changes affecting DLCO and SPB over~     time during general anaesthesia and mechanical ventilation in patients with otherwise~     healthy lung undergoing elective surgery. This in order to check the timing of the observed~     worsening of alveolar-capillary membrane function, and to find out if the process is~     progressive in time.~      The secondary end point is to check if the alterations of functional features of alveolar~     membrane (DLCO) are proportionate to the increase of alveolar injury marker (SPB), in order~     to understand if the worsening of alveolar-capillary membrane function is to be attributable~     to an anatomical damage or to a physiologic change of the ventilation-perfusion matching.~   "
118576|NCT01503866|"~     The purpose of this study is to determine the absorption and excretion kinetics of~     bardoxolone methyl and to determine and characterize metabolites present in plasma, urine~     and feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.~   "
118577|NCT01503853|"~     Background:~      - The costs of medical care have a major effect on patients during illness and treatment.~     Surveys with patients and doctors show that both are interested in discussing the costs of~     treatment. But they rarely talk about these issues. Both worry about whether it is~     appropriate to discuss financial matters in the clinical setting. They are also concerned~     about whether this topic will be an awkward one. Researchers are interested in studying how~     people want their doctors to talk to them about the costs of illness and medical care.~      Objectives:~      - To explore and better understand patients views on whether and how doctors should talk~     about the costs of illness and medical care.~      Eligibility:~      - English- or Spanish-speaking adults (at least 18 years of age) who are covered by health~     insurance.~      Design:~        -  Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people~          will come together to discuss their thoughts and opinions.~        -  A member of the research team will lead the group discussion. The leader will ask a~          list of questions about health care payment issues. Those in the focus group will~          discuss these issues.~        -  Participants will receive a small cash payment and a light snack.~   "
118578|NCT01503840|"~     Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate~     residual postoperative paralysis but it represents the most simple, inexpensive and~     widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered~     the gold-standard to avoid PORC (post operative residual curarization).~      This clinical trial is conducted to verify the reliability of accelerometer-based~     neuromuscular monitoring in order to exclude postoperative residual paralysis which is not~     highlighted by this instrument at a TOF-ratio=100%.~      The study evaluates patients' neuromuscular recovery evaluated using pulmonary function~     tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF~     ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although~     the monitoring device shows a complete decurarization; patients treated with sugammadex~     should not be capable to perform better pulmonary function tests if a TOF ratio=100% is~     reliable.~   "
120796|NCT01474811|"~     The primary purpose of the HCV-TARGET study is to establish a nationwide registry of~     patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both~     academic and community practices.~   "
118579|NCT01503827|"~     People with brain metastases from melanoma are offered different treatment options after~     local treatment of their brain metastases via surgery or stereotactic irradiation. Depending~     on the treating institution and the clinician involved a patient may or may not be offered~     whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with~     stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain~     metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT~     on quality of life and brain functions such as memory, speech and concentration.~     Participants will be randomised after local treatment of their brain metastases to either~     WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK,~     the US and other international sites.~   "
118580|NCT01503814|"~     The goal of this study is to develop, pilot test, and evaluate a highly simplified but~     guideline-based program for cardiovascular management for application in resource-scarce~     settings. The study aims to assess the effects of implementing a simple low-cost~     cardiovascular management program for high-risk individuals, delivered by primary care~     providers (PCPs) or community health workers (CHWs), on the proportion of patients~     appropriately treated with diuretics as well as a number of secondary outcomes in~     resource-scarce Tibet, China and Haryana India.~   "
118581|NCT01503801|"~     Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence~     will:~        1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death~        2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital~          stay without increasing adverse effect~   "
118582|NCT01503788|"~     Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is~     a common procedure in everyday clinical practice. The most common use for LP is to measure~     the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is~     also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.~      A notorious side effect of dural puncture is headache that ranges from mild to debilitating~     and may last for several days following the procedure. Among diagnosed patients, 39%~     experience at least 1 week of impaired ability to perform activities of daily living. The~     likelihood of developing a headache after dural puncture depends on a number of factors. As~     fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize~     the leak seem to offer the best path to lowering the incidence of headache after diagnostic~     LP, the commonest clinical context of dural puncture in medical practice.~      Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety~     cause adrenergic stimulation, they also cause an increase in ICP. We believe that this mild~     increase in ICP, occurring before the puncture as well as during the puncture itself may~     exacerbate the pressure difference between the CSF space and the epidural space and so~     worsen the CSF leak Furthermore, this excess pressure, although mild, might cause the dural~     puncture hole to widen slightly and so further augment the leak and possibly even prolong~     it. Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may~     cause a sensitization effect and worsen pain. This increase in adrenergic drive as well as~     the sensitization to pain can be effectively blunted by the periprocedural use of mild IV~     sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this~     task.~      This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on~     the rates of headache after diagnostic LP.~      Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo~     the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior~     to the procedure and undergo the same diagnostic procedure. All patients in the study will~     remain under observation in the hospital for at least 6 hours.~      Patients will be evaluated for headache and specifically for headache. Clinical follow up~     will continue for 72 hours by administering a short questionnaire over the telephone.~   "
118583|NCT01503775|"~     The objective of this study is to evaluate the long term efficacy and safety of the CODMAN~     TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or~     non-ruptured aneurysms in real-life routine clinical practice.~   "
118584|NCT01503762|"~     Objective: The purpose of this study is to determine effects of mirror therapy in restoring~     hand function in patients with flexor lag following orthopedic injuries.~      Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be~     measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for~     3-week, as well, half an hour conventional rehabilitation after each mirror therapy session.~     Patients in the control group will receive the same treatment program, but instead of~     mirror, they will directly observe the affected hand. Outcome measures including Total~     Active Motion (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be~     administered before and after the treatment period and 3 weeks after the final treatment~     session.~   "
118585|NCT01503749|"~     The investigators aim to investigate the safety and efficacy of peripheral blood monocyte~     for the treatment of patients with advanced liver cirrhosis.~   "
118586|NCT01503736|"~     The purpose of the study is to determine the effect and optimum dose and evaluate the safety~     of ferric citrate, administered three times daily (TID) immediately after meals for a total~     daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end~     stage renal disease (ESRD).~   "
118587|NCT01503723|"~     Metabolomics, or metabonomics, is a large-scale approach to monitoring as many as possible~     of the compounds involved in cellular processes in a single assay to derive metabolic~     profiles. Metabolomics allows for a global assessment of a cellular state within the context~     of the immediate environment, taking into account genetic regulation, altered kinetic~     activity of enzymes, and changes in metabolic reactions. Metabolomics may be useful for~     understanding metabolic imbalances and for diagnosis of human disease. The investigators~     plan to collect exhaled breath condensate from patients with acute lung injury. Metabolomic~     analysis in the patients may help us to explore some novel biomarkers for the disease~     diagnosis and outcome prediction.~   "
118588|NCT01503710|"~     The purpose of this study is to determine soluble HJV could be an early diagnosis urinary~     biomarker of ischemia/reperfusion injury in post CPB-patients.~   "
118589|NCT01503697|"~     Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical~     for targeting angiogenesis associated with diseases such as primary and metastatic cancer,~     and for targeting active fibrosis in cardiac diseases such as developing heart failure and~     developing hypertrophic cardiomyopathy.~      A principle goal of imaging is identification of disease processes early in their~     development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour~     to exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early~     in the growth of a tumour it is postulated that imaging of angiogenesis can assist in early~     diagnosis of cancer, relapse or spread, and monitoring response to therapy.~      Technetium-99m NC100692 Injection will be tested on 3 populations of pts:~      1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients~     with locally advanced breast cancer undergoing treatment.~   "
118590|NCT01503684|"~     In this proposal, the investigators wish to investigate, identify and validate potential~     biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.~   "
118591|NCT01503671|"~     Background~      Heart failure is the final consequence of various heart disease and is also the leading~     cause of mortality worldwide. Diastolic dysfunction refers to an abnormality of diastolic~     distensibility, filling, or relaxation of the left ventricle. Patients with hypertensive~     left ventricular hypertrophy and an echocardiogram showing a normal ejection fraction and~     abnormal left ventricular filling can be said to have diastolic dysfunction. If pulmonary~     edema or effort dyspnea developed in such a patient. The term diastolic heart failure would~     be appropriate.~      Pathology leading to diastolic heart failure include: impaired relaxation, increased passive~     stiffness, endocardial and pericardial disorders, microvascular flow and neurohormonal~     regulation. Among them, the association of pro-inflammatory system and diastolic dysfunction~     are already established. The investigators therefore hypothesized that the change of serum~     inflammatory markers might be associated with the change of left ventricular diastolic~     function and the investigators thus conducted a randomized case-control trial with this~     regard.~      Method and materials~      This is a case-control randomized study. The definition of left ventricular diastolic~     function is according to Guideline from the ACC and AHA. The investigators will evaluate~     left ventricular diastolic function noninvasively by echocardiography before and after the~     intervention. Exclusion criteria include coronary artery disease, significant valvular heart~     disease, cardiomyopathy, pericardial disease and renal insufficiency. The investigators~     would like to enroll 50 cases and the same numbers of the controls. The inclusion criteria~     are subjects who underwent peritoneal dialysis at the investigators hospital for more than 6~     months with higher pro-inflammation serum cytokine levels (C-reactive protein > 0.2mg/dL).~     Atorvastatin (40mg/day) would be given to those who were allocated to the intervention~     group. The investigators will than follow up cardiac diastolic function by echocardiography~     and also the change of serum markers. The investigators would also genotype the~     inflammation-associated genes and their promoter region and find the association between~     genetic polymorphisms and the treatment effects of statins.~   "
118592|NCT01503658|"~     This study has an open-label, five-period, single-sequence design. The purpose of this study~     is as follows;~        1. Primary~             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter~               on the pharmacokinetics/pharmacodynamics of clopidogrel~             -  To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of~               clopidogrel~        2. Secondary~             -  To explore the representative biomarkers for the variable~               pharmacokinetics/pharmacodynamics of clopidogrel~             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter~               on the drug-drug interactions between aspirin and clopidogrel~             -  To explore the representative biomarkers for the drug-drug interactions between~               aspirin and clopidogrel~   "
118593|NCT01503645|"~     1. Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may~          be related to the a component called aristolochic acid (AA).~        2. AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney~          failure and/or cancer~        3. Different enzymes have been reported to detoxify plant alkaloids or other components.~          Genes that regulate the production of these metabolic enzymes may affect the chance of~          CHN.~        4. By comparing the differences in the polymorphisms of these genes between patient with~          CHN and control, we may find the changes that play a significant genetic factors for~          CHN.~   "
118594|NCT01503632|"~     This randomized phase III trial studies compliance to a mercaptopurine treatment~     intervention compared to standard of care in younger patients with acute lymphoblastic~     leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia~     to take their medications as prescribed may help them in taking their medications more~     consistently and may improve treatment outcomes.~   "
118595|NCT01503619|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from~     patients with small cell lung cancer registered on CALGB-140202.~   "
118596|NCT01503606|"~     The purpose of this study is to compare the neonatal outcome and infant neurologic outcome~     whose mother were treated with cefazolin plus clarithromycin for one week or until delivery~     after preterm premature rupture of membrane.~   "
118597|NCT01503593|"~     The study was designed to assess the effectiveness of conservation ridge preservation~     (horizontal and vertical dimension) after tooth extraction with and without combination of~     bone substitutes based on synthetic (calcium sulfate mixed with phosphate.~   "
118598|NCT01503580|"~     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the~     etiology of OAB was complicated and unclear in many aspects. In particular, the research~     about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic~     factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the~     aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric~     aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to~     analyze the differences of cardiac conduction and heart rate variability before and after~     tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB~     and OAB female patients, and before and after tolterodine treatment.~   "
118599|NCT01503567|"~     This study is conducted in Africa and Asia. The aim of this study is to evaluate in the~     participating countries the orthopaedic status and the degree of arthropathy of severe~     haemophilia patients in general.~   "
118600|NCT01503554|"~     In an effort to improve care coordination and reduce hospital readmissions, Rush University~     Medical Center developed the Combined Social Worker and Pharmacist Program, which targets~     both the psychosocial and clinical risk factors that can lead to rehospitalization. This~     study will evaluate the impact of this program on 30-day same hospital readmission rates and~     total cost of care.~   "
118601|NCT01503541|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid~     leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.~   "
118602|NCT01503528|"~     This study is designed to determine if three different methods for providing postoperative~     analgesia following total knee joint arthroplasty affect outcomes. These outcomes include~     pain and function for a period of up to 3 months, and specific non-pain outcomes, including~     cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and~     vomiting and urinary retention.~      Economic outcomes will also be examined, including length of hospital stay, direct health~     care costs and patient satisfaction.~   "
118603|NCT01503515|"~     This randomized phase III trial studies how well caspofungin acetate works compared to~     fluconazole or voriconazole in preventing fungal infections in patients following donor stem~     cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in~     preventing fungal infections in patients following donor stem cell transplant. It is not yet~     known whether caspofungin acetate is more effective than fluconazole or voriconazole in~     preventing fungal infections in patients following donor stem cell transplant.~   "
118604|NCT01503502|"~     It is an open-label, randomized, multi-center study. The efficacy and safety of two~     flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib~     400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia~     chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).~   "
118605|NCT01503489|"~     The present study aimed at identifying clinical risk factors for switch into (hypo)mania or~     mixed states, within 8 weeks after introduction of an antidepressant or after increasing its~     dosage.~   "
118606|NCT01503476|"~     Study Hypothesis:~      This study is designed as an integral part of the development of new or improved features or~     components of the Bravo® pH Monitoring System and may serve verification and validation~     purposes The study population will include a group of healthy volunteers (Group A) and a~     group of symptomatic patients with known or suspected gastroesophageal reflux disease (Group~     B).~      Group A: Healthy volunteers will not undergo invasive procedure. These volunteers may be~     asked to carry the capsule and\or Bravo Recorder. These procedures will serve to evaluate~     different technical matters such as human interface, ergonomic aspects and communication~     performances of the system Group B: Symptomatic patients will undergo invasive procedure,~     including Bravo capsule delivery, positioning and attachment. Confirmation of capsule~     attachment may be done by endoscopically.~      These procedures will serve to evaluate overall system performance in actual clinical setup,~     for instance: Bravo Recorder performance including communication quality, human interface~     and similar, ergonomics of delivery device, pH Capsule performance, etc.~      Subjects from both study groups as well as physician may be asked to provide feedback on the~     procedure and/or document their activities during the procedure.~   "
118607|NCT01503463|"~     The purpose of this study is to evaluate whether telemonitoring of patients with chronic~     heart failure produces a reduction in the combined end point of all cause mortality and~     number of hospitalisations, and whether it improves health related quality of life. In~     addition, the trials evaluate the economic and organisational impact of the telemonitoring~     service and examine its acceptability by patients and health professionals.~   "
118608|NCT01503450|"~     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5~     mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse~     events and ensure safety of subjects.~   "
118609|NCT01503437|"~     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5~     mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor~     adverse events and ensure safety of subjects.~   "
118610|NCT01503424|"~     The purpose of this study is to compare the bioequivalence and characterize the profile of~     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects~     under fed conditions and to monitor the adverse events and ensure the safety of the~     subjects.~   "
118611|NCT01503411|"~     The primary objective of this clinical trial is to evaluate the performance of the Nvision~     Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects~     undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training~     implications for introducing this new imaging modality.~   "
118612|NCT01503398|"~     The purpose of this study is to compare the bioequivalence and characterize the profile of~     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects~     under fasting conditions and to monitor the adverse events and ensure the safety of the~     subjects.~   "
118613|NCT01503385|"~     Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small~     cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP)~     regimen is one of the most commonly used regimens. However, the prognosis of these patients~     is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an~     important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote~     chemosensitivity and radiosensitivity of tumor cells in preclinical trials.~      This is a single-institution, open-label, randomized phase II trial of celecoxib~     administered concurrently with cisplatin, etoposide, and radiation therapy in patients with~     locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this~     combination on unresectable NSCLC, and further to examine biomarkers to predict response to~     the treatment.~   "
118614|NCT01503372|"~     The prognosis of advanced gastric cancer and adenocarcinoma of the gastro-esophageal (GE)~     junction is poor. Even with modern chemotherapy the median survival ranges around 8-10~     months.~      Inhibition of neoangiogenesis seems to be a very promising approach in gastric cancer.~      Vascular endothelial growth factor (VEGF) acts as one of the most potent stimulating agents~     of angiogenesis, and several strategies targeting the VEGF signaling pathway have been~     developed, including anti-VEGF antibodies, soluble receptors binding directly to VEGF~     ligand, anti-VEGF receptor (VEGFR) antibodies and VEGFR tyrosine kinase inhibitors. The~     breakthrough in the clinical development of anti-angiogenic therapy against colorectal~     cancer came in 2003 with a large prospective, randomized clinical trial of bevacizumab, a~     monoclonal antibody directed against VEGF. Anti-angiogenic therapy has introduced a highly~     effective, completely new mode of action in this area and is the new standard of care in~     advanced colorectal cancer.~      The concept of VEGF inhibition is also very promising in gastric cancer. Bevacizumab was~     investigated in combination with irinotecan and cisplatin in a phase-II trial, including 47~     patients with gastric and GE-junction carcinoma. Bevacizumab could safely be given and could~     improve time to tumor progression by 75% compared to historical controls. Several phase-II~     trials confirm the tolerability and promising efficacy of bevacizumab in gastric cancer~     (Bevacizumab + Docetaxel/Oxaliplatin; FOLFOX + Bevacizumab; Docetaxel/Cisplatin/Irinotecan +~     Bevacizumab). These results were so promising that randomized phase-III trials in the~     1st-line and perioperative setting are under way (AVAGAST-trial: Cisplatin /Capecitabine +/-~     bevacizumab 1st line ; MAGIC-B-trial : ECX +/- bevacizumab perioperative).~      Tyrosin kinase inhibitors which inhibit VEGF receptors and EGFR are also investigated in~     gastric cancer with promising efficacy. Pazopanib, an orally available tyrosine kinase~     inhibitor, selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2~     and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which results in~     inhibition of angiogenesis in tumors in which these receptors are upregulated. Pazopanib has~     the advantage of being an orally available anti-angiogenesis component.~      Pazopanib shows promising activity in phase-II trials in renal cell cancer, breast cancer,~     soft tissue sarcoma and non small cell lung cancer. A phase-III trial of pazopanib in renal~     cell cancer (NCT00334282) is completed and resulted in the approval of Pazopanib for this~     disease. A phase-III trial in soft tissue sarcoma (NCT00753688) is currently performed.~      In phase-I trials, pazopanib was investigated in combination with FOLFOX and~     Capecitabine/Oxaliplatin. FOLFOX could be administered in full dose with 800 mg pazopanib.~     In Cape/Ox, capecitabine had to be reduced to 850mg/m² bd.~      5-FU- and oxaliplatin-based regimens are one of the established treatment standards for~     1st-line therapy in metastatic gastric cancer. The efficacy of 5-FU, leukovorin and~     oxaliplatin (FLO) compared to 5-FU, cisplatin could be confirmed in a randomized phase-III~     trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). FLO has a favorable~     toxicity profile. In Germany, FLO is a widely used combination for advanced gastric cancer~     and is a recommended regimen in the new German S3-guidelines 2011.~      The investigators therefore want to examine FLO + pazopanib.~   "
118615|NCT01503359|"~     The purpose of study is to determine whether dietary supplement sarcosine is effective in~     treatment of schizophrenia. The investigators will assess impact of sarcosine on quality of~     life and sexual functioning. In this project the investigators will also measure glycine,~     sarcosine, BDNF, MMP-9 levels and oxydative stress parameters in blood, brain glutamatergic~     metabolism parameters in magnetic resonance spectroscopy and oculomotoric changes in~     electrooculography.~   "
118616|NCT01503346|"~     Appetite loss is a severe and common symptom among late-stage cancer patients, and it causes~     great the anxiety for the patient's family. In TCM theory, the investigators call these~     patients are in block and repulsion condition. The investigators try to set a study to use~     the herbal medicine solution taken in frequent small amounts by cancer patients in~     late-stage to improve the appetite loss condition. Through this method, the investigators~     not only want to improve the quality of life of cancer patients in late-stage but also set a~     valuable treatment.~   "
118617|NCT01503333|"~     The purpose of this school-based trial is to test the efficacy of an intervention to~     increase moderate to vigorous physical activity (MVPA) among middle school girls. The~     17-week Girls on the Move (GOTM) intervention has 3 components. Two individual-level~     components occurring during school hours include: (1) two face-to-face motivational,~     individually tailored counseling sessions with a school nurse, and (2) an interactive~     Internet-based session during which each girl receives motivational, individually tailored~     feedback messages (at 9 weeks). A group-level component, 90-minute Physical Activity (PA)~     Club provides an important venue after school that includes activities to assist girls in~     establishing a behavioral pattern of MVPA. The control condition will complete data~     collection activities and receive their usual school offerings.~      The investigators hypothesize that immediately post-intervention, minutes of MVPA will be~     greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention~     follow-up, minutes of MVPA will be greater in the intervention than control group; and~     immediately post-intervention and 9-mo. post-intervention follow-up, cardiovascular (CV)~     fitness will be higher and body mass index (BMI) and percent body fat will be lower in the~     intervention than control group.~   "
118618|NCT01503320|"~     Acute pancreatitis (AP) is a potentially serious illness characterized by inflammation of~     the pancreas with variable involvement of peri-pancreatic tissues and/ or remote organ~     systems. AP is hyper catabolic condition due to systemic inflammatory response syndrome~     (SIRS without any proven specific treatments. Therefore, current therapy for AP is directed~     to intensive medical care, nutrition support and infection control.~      Nutritional support is very crucial in the treatment of AP. Enteral nutrition (EN) is the~     preferred modality since parenteral nutrition is associated with various complications. EN~     could preserve the intestinal permeability, which would be the best barrier for prevention~     of certain complications.~      Glutamine is the most abundant free amino acid in the body and is used as a major fuel and~     nucleotide substrate. When a nutritional deficiency arises in critical illness including~     SAP, glutamine tends to be conditionally depleted.~      We hypothesize that enteral glutamine supplementation in patients with severe and predicted~     severe acute pancreatitis helps in their early recovery and prevention of adverse outcomes.~      In this study, we aim to evaluate the therapeutic effect of enteral glutamine on clinical~     outcomes, gut permeability, systemic inflammation, oxidative stress and plasma glutamine~     levels.~   "
118619|NCT01503307|"~     The purpose of this research study is to learn about parents' experiences following~     diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other~     health-care clinicians will benefit from an improved understanding of what the diagnosis~     means to parents and what they expect concerning the infant, being a parent, and caregiving~     tasks and responsibilities. The investigators expect that the knowledge gained will increase~     clinicians' ability to respond to parents' needs.~   "
118620|NCT01503294|"~     Assessment and evaluation of body temperature is an important sign of health and disease.~     Inferior thermometry increases the risk of morbidity and mortality, and increases health~     care cost by delaying the diagnosis and treatment of fever-related disease. The gold~     standard for measuring core body temperature is the pulmonary artery thermistor (PAT). The~     measurement of the PAT requires the insertion of the invasive pulmonary artery catheter, a~     high risk procedure.~      An innovative thermometry technology, the temporal artery thermometer (TAT), has been~     introduced into the clinical arena as a potential non-invasive proxy for the PAT. The TAT~     reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring~     core blood temperature by measuring temperature over the skin of the temporal artery.~      Research to demonstrate the precision and accuracy of the TAT in normothermic patients has~     been published, but little to no data is available in those with temperatures greater than~     100.4oF. The purpose of this study is to measure the precision and accuracy of 2standard of~     care temperature methods: the thermistor from the PAT, considered the gold standard, and the~     TAT as measured in those patients with a PAT temperature greater than 100.4oF.~   "
118621|NCT01503281|"~     The aim of this study was to compare the effect of a hospital group-based vs. home-based~     combined exercise-diet program for the treatment of childhood obesity.~   "
118622|NCT01503268|"~     Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with~     medications, but these are not always effective or tolerated. Ablation is a well-recognised~     technique that is recommended for those with symptomatic AF who have failed medical therapy.~      Ablation can be performed in a number of ways. In percutaneous ablation, ablation is~     performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic~     ablation, ablation is performed under general anaesthetic via very small incisions in the~     chest wall.~      Because AF can be intermittent, the only reliable way to look for it is with long-term ECG~     monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).~      In this study, the investigators are trying to see if minimally-invasive thoracoscopic~     ablation is better than percutaneous ablation, and in turn if they are better than Direct~     current cardioversion (DCCV), using ILRs to monitor AF.~   "
118623|NCT01503255|"~     This study will determine whether a group cognitive-behavioral therapy intervention that~     demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in~     western Kenya is effective when compared against a group health education intervention in a~     large sample over a longer period of time. It will be delivered by paraprofessionals,~     individuals with limited formal education and little or no relevant professional experience.~     This approach is consistent with successful cost-effective models of service delivery in~     resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional~     birth attendants and peer counselors) are trained.~   "
118624|NCT01503242|"~     This phase I trial studies the side effects and best dose of yttrium Y 90 anti-CD45~     monoclonal antibody BC8 when given together with fludarabine phosphate and total-body~     irradiation followed by donor peripheral blood stem cell transplant in treating patients~     with multiple myeloma. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45~     monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them~     without harming normal cells. Giving chemotherapy drugs, such as fludarabine phosphate, and~     total-body irradiation before a donor peripheral blood stem cell transplant helps stop the~     growth of cancer cells and helps stop the patient's immune system from rejecting the donor's~     stem cells. When the healthy stem cells from a donor are infused into the patient they may~     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving yttrium Y 90 anti-CD45 monoclonal antibody BC8, fludarabine~     phosphate, and total-body irradiation before the transplant together with cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening and may be an~     effective treatment for multiple myeloma.~   "
118625|NCT01503229|"~     This phase II trial studies how well abiraterone acetate works in treating patients with~     hormone-resistant prostate cancer that has spread from the primary site (place where it~     started) to other places in the body (metastatic). Abiraterone acetate may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
118626|NCT01503216|"~     The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured~     by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively,~     and by total 25(OH)D.~   "
118640|NCT01503034|"~     This is a non-interventional, retrospective, multicentre study involving women having had a~     breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and~     non-pregnant women having had a breast cancer between 2000 and 2009 (controls).~   "
118627|NCT01503203|"~     The purpose of this study will be assess the effectiveness of the physical virtual training~     on nonspecific chronic low back pain, body balance, functional autonomy and mood of older~     women. Two groups will be formed. One will do strength exercises and core training. The~     other group will do the same exercises more virtual activities with Nintendo Wii. Will be~     measure pre and post-intervention of the responses already shown above.~   "
118628|NCT01503190|"~     This study plans to learn more about the immune system's response to breast cancer in young~     women.~   "
118629|NCT01503177|"~     This phase I clinical trial investigates the side effects and the best dose of local~     (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma~     (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles~     virus will enable the virus to specifically infect and kill cancer cells and spare, without~     damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an~     anti-tumor immune response which will result in additional destruction of the tumor by~     immune cells~   "
118630|NCT01503164|"~     Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general~     population and is associated with several medical conditions including hypertension and~     coronary artery. Research over the last decade has shown that obstructive sleep apnea may~     also increase the propensity for insulin resistance, glucose intolerance, and type 2~     diabetes mellitus. Positive airway pressure (PAP) is the first line therapy for the~     treatment of obstructive sleep apnea. While PAP therapy has several favorable effects such~     as improvements in daytime sleepiness and quality of life, it is not clear whether using PAP~     therapy can alter metabolic risk. The overall objective of this study is to examine whether~     treatment of obstructive sleep apnea with positive airway pressure therapy improves glucose~     tolerance and insulin sensitivity. The primary hypothesis of this study is that PAP therapy~     of obstructive sleep apnea will improve in insulin sensitivity and glucose metabolism.~   "
118631|NCT01503151|"~     Adults with Social Phobia will be randomly assigned to either an attention bias modification~     treatment, interpretation bias modification treatment, both, or a placebo control condition~     not designed to change cognitive bias patterns.~      Outcome measures will be social anxiety symptoms and severity as measured by gold standard~     questionnaires as well as diagnosis of social phobia disorder and symptom counts derived~     from structured clinical interviews based on DSM-IV criteria.~      The investigators expect to find significant reduction in social anxiety symptoms in the~     Treatment groups relative to the placebo control group. The investigators want to find out~     the relative efficacy of attention and interpretation oriented treatments and the~     combination of the two.~   "
118632|NCT01503138|"~     The purpose of this study is to evaluate the efficacy of a purpose-built intervention in~     improving the mental health of abused Mainland Chinese immigrant women in a community in~     Hong Kong.~   "
118633|NCT01503125|"~     Giant Axonal Neuropathy (GAN) is a devastating and rare childhood disease. Children with GAN~     develop increasing muscle weakness, impaired sensation, and at times mental retardation. GAN~     starts in infancy, leads to significant disability, and typically leads to death within the~     first 30 years of life. GAN is caused by a defect in the gigaxonin (GAN) gene, resulting~     in pathologically enlarged and dysfunctional nerves. Currently, there is no effective~     therapy. To find out what medications can help patients with GAN, the investigators have to~     conduct clinical trials. In this study, the investigators propose to prepare for future~     clinical trials and will invite GAN patients to join our research effort.~      The investigators will examine them regularly to better understand their disease. The visits~     will include questions, a physical exam, blood drawing, a lumbar puncture, and a skin~     biopsy. The visits will also include tests that assess the electrical conductivity of the~     patients' nerves as well as a test to measure the patients' brain wave activity. In~     addition, the investigators will be performing tests to evaluate the patients' motor~     function, their vision, and thinking ability. Identifying an effective GAN treatment is very~     important because there is currently none. Clinical trials are the only way to decide~     whether a new treatment works in GAN patients or not.~      With the future objective of conducting clinical trials in GAN, the proposed project has~     three specific aims. The first is to plan for clinical trials by developing reliable outcome~     measures, and establishing the infrastructure needed to carry out efficient clinical trials.~     The second is to further characterize the patient population from a clinical and molecular~     point of view, and the third aim is to utilize the information gathered in this study to~     further pre-clinical GAN drug development to select candidate drugs.~   "
118634|NCT01503112|"~     Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the~     blood glucose (sugar) from going too high helps prevent complications. Recently a number of~     new treatments (collectively called 'incretin based' treatments) to lower blood glucose have~     become available but response is very variable and it is difficult to predict which will~     work for an individual. The investigators want to see if we can identify whether the new~     treatments are likely to be effective for an individual patient. Identifying the right~     treatment would improve control and minimise the side-effects and costs from ineffective~     treatments. We will collect blood (for measures of blood glucose, insulin secretion and~     genetics information), urine (for a simple measurement of insulin secretion) and other~     clinical information (such as weight,age, duration of diabetes and medication) in people who~     are about to start these new 'incretin based' treatments and assess their response over the~     first 6 months of treatment. We will analyse this information to see if we can predict~     treatment response.~      Study Hypothesis:~      The investigators hypothesise that those who have low insulin secretion, as measured by post~     meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose~     response to incretin based treatments.~   "
118635|NCT01503099|"~     One aims to devise a method for the screening and differentiation of intestinal tuberculosis~     and Crohn's Disease. Additionally, one aims to detect and survey multidrug resistant TB.~   "
118636|NCT01503086|"~     This randomized clinical trial studies how well an adaptive computerized cognitive training~     program works compared to a non-adaptive computerized cognitive training program in treating~     younger patients with brain tumor who underwent radiation therapy. Providing a computer~     training program may improve the well-being and quality of life of patients with cognitive~     (physical and mental) function difficulties caused by radiation therapy to the brain.~   "
118637|NCT01503073|"~     Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve~     a variety of functions.~   "
118638|NCT01503060|"~     The aim of this study is to find out the effects of routinely using different types of~     pain-relieving strategies during routine immunization injections performed in infants.~   "
118639|NCT01503047|"~     The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and~     t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals~     who maintained their normal dietary and exercise patterns.~   "
118641|NCT01503021|"~     The purpose of the parent study is to assess the short-term safety and tolerability of~     soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of~     representative adult chronic kidney disease patients on hemodialysis (CKD-HD).~      The purpose of the extension study is to assess the long-term safety and tolerability of~     SFP.~   "
118642|NCT01503008|"~     The study will test whether the Proteus Sustained Behavior Change (SBC) System will help~     Type 2 diabetics feel more able to perform self-care activities, feel less distressed about~     diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and~     wearable sensing devices and mobile phones to reinforce positive behaviors around medication~     usage, exercise and rest.~   "
118643|NCT01502995|"~     The purpose of this study is to determine whether a laser light beam, attached to a rolling~     walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's~     disease.~   "
118644|NCT01502982|"~     The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous~     system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients~     is feasible and could improve time to treatment failure and reduce the risk of CNS relapses.~     Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison~     (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course~     of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be~     compared to a historical Nordic study.~   "
118645|NCT01502969|"~     This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety~     and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of~     Vaccines and Biologicals, Vietnam.~   "
118646|NCT01502956|"~     The purpose of this randomized, open-label, active-control trial is to compare the~     effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral~     neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary~     incontinence. In addition, the study will evaluate select technical attributes of the~     interventions as well as the effect of these two interventions on other lower urinary tract~     and pelvic floor symptoms.~      Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary~     incontinence episodes over the 6-month follow-up period as compared to Botox A® injection.~      A supplemental study investigates whether biological markers including those related to~     inflammation and connective tissue remodeling change following treatments with Botox A® and~     Interstim®.~   "
118647|NCT01502943|"~     The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD)~     as examples to build a standard evaluation system for efficacy of traditional Chinese~     medicine (TCM).~        1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes~          of CHD and self-administrated scale of Stable Angina Pectoris~        2. research on all indicators of CHD, and analyze their characteristics, target and~          function~        3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood~          and dissolving stasis as an example for clinical efficacy evaluation.~   "
118648|NCT01502930|"~     This study is a randomized controlled trial (RCT) to evaluate the effect of an~     internet-based, guided self-help treatment of reoccurring and distressing nightmares.~     Imagery Rehearsal Therapy (IRT) will be compared to an active control treatment (CONT) and a~     recording-only group (REG). It is hypothesized that both active treatments will be superior~     to REG, and that IRT will be superior to CONT.~   "
118649|NCT01502917|"~     The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic~     Pontine Glioma (DIPG). The researchers will use convection-enhanced delivery (CED) to~     deliver an agent called 124I-8H9. CED is performed during surgery. The study agent is~     infused through a small tube placed into the tumor in the brain. Many studies have shown~     this can safely be done in animals but this study is the first time 124I-8H9 will be given~     by CED in humans. This will be one of the first times that CED has been performed in the~     brain stem.~      8H9 is something called an antibody. Antibodies are made by the body to fight infections and~     sometimes cancer. The antibody 8H9 is produced by mice and can attack many kinds of tumors.~     A radioactive substance, 124I, is attached to 8H9. 124I-8H9 sticks to parts of tumor cells~     and can cause the tumor cells to die from radiation. Studies have also been done on humans~     using 124I-8H9 to treat other kinds of cancer. Our studies of some DPG and related tumors~     suggest that 8H9 will bind to the tumor, but the investigators don't know that for sure.~      In this study, the researchers want to find out how safe 124I-8H9 given by CED is at~     different dose levels. They will look to see what effects (both good and bad) it has on the~     patient. The dose of 124I-8H9 will increase for each new group of patients. The procedure~     has already been safely performed with lower doses and infusion volumes in a number of~     patients here at MSKCC. The amount they get will depend on when they enter the study. If too~     many serious side effects are seen with a certain dose, no one will be treated with a higher~     dose, and some more patients may be treated with a lower dose to make sure that dose is~     safe.~      Select patients may be eligible for repeat infusions of 124I-8H9 with co-infusion of the~     surrogate tracer, Gd-DTPA. Patients will undergo the same pre and post treatment evaluations~     after each injection with a minimum 30 day observation window between injections.~   "
118650|NCT01502904|"~     There has been little research on neointimal coverage and malapposition after BES~     implantation using OCT in human coronary artery. Furthermore, specific drug may possibly~     influence the vascular healing after stent implantation. Therefore, this study will~     investigate 1) neointimal coverage and malapposition on OCT after BES versus SES~     implantation and 2) relationship of specific drug treatment and neointimal coverage or late~     malapposition by the prospective, randomized study.~   "
118651|NCT01502891|"~     The purpose of this study is to determine whether the Depression Medication Choice decision~     aid is effective in involving patients with depression in making deliberate choices when~     considering medication treatment.~   "
118652|NCT01502878|"~     Nut sensitization in skin prick tests is common in areas, including Finland, where birch~     pollen is abundant. However, sensitization to nuts in skin prick test does not predict the~     possibility of allergic symptoms when nuts are ingested. In this study the investigators~     launch and perform double-blind placebo-controlled nut challenges and oral desensitization/~     protocol to those with serious symptoms in the challenge. The efficacy and safety of the new~     oral desensitization program is the primary outcome. The effect of oral desensitization on~     bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are~     secondary outcomes.~   "
118653|NCT01502865|"~     The overall objective of this project is to conduct a feasibility study using data proved by~     Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate~     goal of establishing a mechanism by which VA clinicians could access data on Veterans~     regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as~     documented in the Department of Defense Suicide Event Report (DoDSER).~   "
118654|NCT01502852|"~     The purpose of this study is to explore and potentially increase the capacity of the non-VA~     community mental health system within the state of Colorado to provide a comprehensive and~     coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi~     Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF~     Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health~     issues.~   "
118655|NCT01502839|"~     The purpose of this study is to examine differences in post-concussive (PC) symptom~     endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom~     (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury~     (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history~     of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those~     with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on~     the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous~     research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom~     endorsement (Brenner et al. 2010; Terrio et al, 2009).~      HYPOTHESES ARE AS FOLLOWS:~        1. Individuals with a history of target, service-related, mTBI only (Group 2) and~          individuals with PTSD only (Group 3) each will report significantly more PC symptoms,~          as measured by NSI total scores, when compared to those with no history of~          service-related mTBI or PTSD (Group 4).~        2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1)~          will report significantly more PC symptoms, as measured by total NSI scores, than~          either those with target, service-related, mTBI only (Group 2) or those with PTSD only~          (Group 3).~   "
118656|NCT01502826|"~     Childhood obesity is increasing at a fast pace, together with its complications. The aim of~     the present study is to assess several candidate triggering agents, mechanisms and~     intermediate phenotypes of atherosclerosis during the post-prandial phase in the obese~     insulin-resistant child/adolescent.~   "
118657|NCT01502813|"~     The purpose of this study is to determine the functional effects of a citicoline, creatine,~     and omega-3 fatty acids combination when administered for a duration of four weeks (28 days)~     to non-psychiatric adult female participants.~   "
118658|NCT01502800|"~     Primary Objective:~      To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761~     administered intravenously.~      Secondary Objectives:~      To determine the pharmacokinetic profile of ARQ 761 To assess the preliminary anti-tumor~     activity of aRQ 761~   "
118659|NCT01502787|"~     The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang~     II)-induced increase in oxidative stress, thereby attenuating Ang II-induced~     vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise,~     thereby reducing functional skeletal muscle ischemia in hypertensive patients.~   "
118660|NCT01502774|"~     Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI).~     The investigators recently reported that cyclosporine A, when administered immediately prior~     to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI~     (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is~     to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred~     and seventy two patients with ST elevation MI will be entered into a multicentre,~     randomized, placebo-controlled, double-blinded study. They will receive one single injection~     of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to~     reperfusion therapy by PCI. The incidence of the combined endpoint (mortality,~     hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one~     year and three years after treatment.~   "
118661|NCT01502761|"~     Stroke is the second leading cause of death and the leading cause of adult disability~     worldwide. This investigation will address the safety and feasibility of directed,~     intra-arterial Magnesium measurement and therapy, through endovascular access, in acute~     stroke patients. The proposal represents the first study to directly quantify levels of a~     systemically administered neuroprotectant in the region of cerebral ischemia. It also~     establishes a novel endovascular platform for direct delivery of neuroprotective agents to~     ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve~     patient care by establishing a novel delivery mechanism for the rescue of threatened brain~     parenchyma that can be administered rapidly following acute stroke. If successful, this~     selective distribution will allow delivery to at risk tissue in a rapid manner. Salvage of~     viable, but threatened, penumbral tissue could afford stroke patients an increased~     probability of favorable long term outcome. The investigators hypothesize that endovascular,~     intra-arterial, Magnesium administration will deliver high concentration of this~     neuroprotective agent to otherwise inaccessible cerebral territories, while limiting~     systemic concentrations. The proposed investigation will evaluate the safety and feasibility~     of this novel treatment technique~   "
118662|NCT01502748|"~     This investigation will address the safety and feasibility of distal, intra-arterial~     sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be~     measured in the region of infarct in patients who had been treated with intravenous~     Magnesium therapy following an acute stroke. This study attempts to address whether the~     traditional intravenous means of neuroprotectant administration achieves adequate~     concentration of the therapeutic agent in the area of diseased tissue.~   "
118663|NCT01502735|"~     This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention~     of dengue fever.~   "
118664|NCT01502722|"~     The purpose of this study is to determine if regular soft drinks (with sugar) have the same~     effect on thirst as diet soft drinks(with sweeteners).~   "
118665|NCT01502709|"~     The investigators propose to conduct a randomized blinded placebo-controlled clinical trial~     in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either~     active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected~     prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and~     symptoms of TMD, and any adverse events.~   "
118714|NCT01502072|"~     The goal of this clinical research study is to learn if ribavirin can help to control RSV in~     patients with immune systems that have been weakened by a stem cell transplant. Researchers~     also want to compare the effectiveness of the drug when it is given by mouth to when it is~     inhaled. The safety of the drug in both methods of delivery will be studied.~      Ribavirin is designed to prevent the RSV virus from making more copies of itself in the~     body.~   "
118666|NCT01502696|"~     Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher~     risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of~     developing stage IV disease to which they will almost invariably succumb. In stage I and II~     patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be~     SN-negative there is still a 25-30% relapse risk.~      The purpose of this study is to evaluate the effectiveness and safety when treated with PEG~     IFN alfa-2b for 2 years as compared to observation (no treatment), administered after~     adequate surgery has been performed for ulcerated primary cutaneous melanomas.~   "
118667|NCT01502683|"~     One of the most devastating complications of coronary artery bypass surgery (CABG) is~     postoperative stroke. While there are multiple causes of stroke after CABG, particles~     generated during handling of the aorta is believed to account for most neurologic effects.~     Handling of the aorta during CABG occurs several times during the operation. One strategy to~     reduce aortic handling is to avoid cardiopulmonary bypass altogether by using off-pump~     techniques (OPCAB). Another method is to avoid the use of aortic clamps and/or to use~     devices that do not require aortic clamping. This study will test the hypothesis that an~     off-pump (OPCAB) approach and devices to perform clampless surgery will result in the least~     amount of aortic handling and therefore the lowest incidence and frequency of neurologic~     adverse events.~   "
118668|NCT01502670|"~     This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully~     lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is~     not approved by the FDA (Food and Drug Administration). This study will help to determine if~     it should be approved by the FDA.~   "
118669|NCT01502657|"~     The purpose of this study is to determine the feasibility and the safety of ultrasound~     guided percutaneous dilatational tracheostomy.~   "
118670|NCT01502644|"~     The purpose of this study is to measure pain relief from chronic low back pain through the~     use of opioid medications (oxycodone and morphine) and the effect of mood symptoms.~   "
118671|NCT01502631|"~     The purpose of this research study is to gather scientific information about the~     effectiveness of the study drug, SUN13837 Injection, when compared with the placebo~     (inactive substance) in subjects with acute spinal cord injury.~   "
118672|NCT01502618|"~     This study involves conducting formative research to develop a culturally appropriate~     secondary prevention intervention for HIV-positive Black young men who have sex with men~     (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT).~     The formative research includes reviewing data and findings from relevant ATN protocols~     (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of~     color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus~     groups with up to 32 HIV- positive B-YMSM.~   "
118673|NCT01502605|"~     This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA)~     (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this~     study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.~      Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the~     tumor can look like normal brain tissue. Studies in other countries have shown that in some~     brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may~     make it easier for doctors to remove as much tumor as safely as possible from your brain.~      This study also hopes to see if 5-ALA can find different cell populations within the tumor~     that is removed and allow the researchers to better understand brain tumors.~      The purpose of this study is to:~        -  Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see~          how well 5-ALA can find different cell populations within brain tumors~        -  Identify the amount of 5-ALA that should be taken before surgery to make the tumors~          glow under ultraviolet light~        -  Make sure the 5-ALA identifies tumor and not normal brain~        -  Make sure 5-ALA does not cause any side effects~   "
118674|NCT01502592|"~     This study is being done to evaluate the safety of two strategies called cryoablation and~     immune therapy in women with curable early stage breast cancer. Cryoablation is a~     procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic~     resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures~     are then applied through the needle to kill the cancer cells. Some of the killed cancer~     cells will be broken into pieces that can be recognized by a person's immune system.~      The immune therapy in this study is a drug called ipilimumab. Normally the immune system~     makes T cells that can kill cancer cells when turned on. The cancer-killing T cell~     activity is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4.~     Turning off CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an~     antibody drug has been made in a laboratory for patient use and was recently approved by the~     United States Food and Drug Administration (FDA) for the treatment of patients with a type~     of skin cancer called melanoma. An antibody is a normal protein that the immune system uses~     to find and kill germs like bacteria and viruses. This study is being done because the~     researchers believe that when cryoablation is combined with immune therapy, a person's~     immune system can be trained to recognize that person's cancer. This may prevent that cancer~     from coming back in the future. In other words, it is hoped that by adding cryoablation with~     ipilimumab before the mastectomy, the body will remain cancer free long after the mastectomy~     is performed. The first step in determining whether cryoablation and immune therapy can be~     used to cure breast cancer is to evaluate the safety of each strategy alone and then in~     combination in a small group of patients.~   "
118675|NCT01502579|"~     The pathological variants of IgA nephropathy identified by the Oxford classification may be~     related to the clinical data at presentation and follow-up, including proteinuria and renal~     function. This study is aimed to identify the potential relationship between pathological~     variants and clinical data in IgA nephropathy.~   "
118696|NCT01502306|"~     California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of~     services and/or incentives on smoking cessation rates. This project has the following~     specific aims:~        1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to~          improve the management of diabetes and other chronic disease by means of tobacco~          cessation.~        2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and~          include modest incentives, are effective in reducing smoking prevalence, lowering~          Medi-Cal health care costs, and improving health outcomes for diabetes management in~          particular.~   "
118676|NCT01502566|"~     Objective:~      The aim of this study is to assess the effectiveness of an oral health educative~     intervention in preventing early childhood caries (ECC).~      Methods:~      The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil.~     Twenty-four public health centres (clusters) were randomly selected and assigned to~     intervention or control group (12 clusters per intervention group). In each center, up to 30~     children/mothers were selected and invited to participate in the trial. Each mother was~     interviewed in order to collect socio-economic and demographic variables. The intervention~     group received by means of a pamphlet the oral health instructions, which were emphasized~     with verbal instructions. Dental examination will be carried out after 1 year for all teeth~     surfaces to determine caries status.~   "
118677|NCT01502553|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the function of device.~        2. Test methods and procedures: Performance test in two positions: Seated and Supine.~        3. DUT: Transtek Blood Pressure Monitor, Model: LS-802. Cuff size: 22-32 cm and 22-42 cm.~        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and~          range: 0-300 mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
118678|NCT01502540|"~     Craniotomies are generally thought to be less painful than other operations. Indeed recent~     studies have confirmed that pain is a common problem during the postoperative phase~     following craniotomy.Pain not only causes discomfort, but it is also associated with other~     potential adverse events such as increased sympathetic activity and elevated systemic blood~     pressure. These events in turn may contribute to increased intracranial pressure. Some~     patients may also develop chronic pain.Potent opioids have been avoided due to its potential~     to cause respiratory depression and risk of masking pupillary signs. As a result~     postoperative craniotomy pain controls are usually inadequate.~      In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no~     definite guidelines for postoperative pain management in these patents due to lack of~     information about quality of postoperative pain control after craniotomy.~      Objectives~      Primary objective :~      - To study incidence of moderate to severe pain during first 48 hours after craniotomy.~      Secondary objectives :~        -  To determine risk factors for moderate to severe pain during first 48 hours after~          craniotomy~        -  To evaluate side effects and complications of postoperative craniotomy pain control~        -  To compare patient's expectation for pain management before and after surgery~        -  To determine patient's satisfaction for postoperative pain management~   "
118679|NCT01502527|"~     Based on previous data published on the SERM properties of Femarelle, the investigators~     hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA)~     symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA~     symptoms in symptomatic post-menopausal women.~   "
118680|NCT01502514|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Heart~          Disease as assessed by a series of measurements indicating improvement, stability, or~          degradation of a patient's cardiovascular function and exercise capacity?~   "
118681|NCT01502501|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Heart~          Disease as assessed by a series of measurements indicating improvement, stability, or~          degradation of a patient's cardiovascular function and exercise capacity?~   "
118682|NCT01502488|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Autism.~   "
118683|NCT01502475|"~     In this protocol, the investigators proposed to assess the Complementary Alternative~     Medicine (CAM) usage patterns in a Veteran population using a CAM survey developed by Dr.~     Hernandez and colleagues. This survey, the Complementary, Alternative and Conventional~     Medicines Attitudes Scale (CACMAS), is a brief, self-report questionnaire that assesses~     medical use patterns, as well as attitudes about medical treatment and the relationship~     among these. The CACMAS will assess the potential role of individual beliefs and attitudes~     towards complementary and conventional medicine usage patterns, and possibly indicate how~     this scale might be used to predict optimal treatment offerings for a particular population~     given attitudes about medical treatments.~   "
118684|NCT01502462|"~     Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without~     significant left-sided valvular or myocardial diseases.~      Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.~   "
118685|NCT01502449|"~     This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy~     intervention designed for primary care treatment of combat-exposed service members with~     PTSD. The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental~     health-related and occupational functioning, and symptoms of depression, anxiety, and~     somatization.~   "
118697|NCT01502293|"~     This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12~     DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12~     EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor~     to initiate and/or enhance anti-tumor immunity.~   "
118711|NCT01502111|"~     An international airway management expert group has recently developed an Utstein-style~     template for uniform reporting of data from prehospital advanced airway management.~     Implementing and validating the template will result in a high quality dataset and allow for~     research cooperation and comparison of airway management practice between EMS systems, and~     across different patient populations. Such a dataset will hopefully contribute to new~     knowledge in the field of prehospital advanced airway management.~   "
118712|NCT01502098|"~     The study aims to establish whether one month postoperative immobilization compared early~     passive motion after rotator cuff arthroscopic repair in small or medium ruptures with~     double row technique has any healing significance.~   "
118713|NCT01502085|"~     Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can~     be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple~     myeloma.~   "
118686|NCT01502436|"~     The purpose of this study is to explore the relationship between attempted and/or completed~     suicide and reported experience of chronic pain among an adult veteran population. Specific~     aims include a) examining the experience of chronic pain between patients who have either~     attempted and/or completed suicide, non-suicide attempt mental health patients, and~     non-mental health chronic pain patients and b) determining possible differences in reported~     experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity,~     occupation, and patient's recorded perceptions of depression and/or quality of life. As~     articulated in the Amendment approved on June 13, 2008, additional areas of interest include~     histories of neurological disease (e.g. traumatic brain injury) and/or mental health~     diagnoses. History of both neurologic disease and mental health diagnoses will also be~     identified by chart review (per approval obtained June 13, 2008). As such this study will~     also compare differences (e.g., mental health, neurological disease) between veterans who~     have history of a suicide attempt, completion, or a lifetime history of suicidality and~     matched control veterans without a history of suicide attempts, completions, or lifetime~     history of suicide. The relationship between suicidal behavior, attempted/completed suicide,~     and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran~     population is also of interest. Additionally, this data set will be used to complete a~     validation study regarding the Self-Directed Violence Classification System (SDVCS).~     Specifically, relevant information in subject chart notes regarding self-directed violence~     (SDV) will be used to categorize thoughts and behaviors according to the SDVCS.~   "
118687|NCT01502423|"~     This study will compare injection site pain levels between current Humira® formulation~     versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are~     either currently on a stable dose (minimum six consecutive doses) of on-label Humira or~     biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid~     Arthritis. The study is being conducted in three countries, Australia (3 sites), Canada (2~     sites), and Germany (2 sites).~   "
118688|NCT01502410|"~     This phase II trial studies how well sorafenib tosylate works in treating younger patients~     with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer.~     Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
118689|NCT01502397|"~     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or~     regular virologic monitoring is the preferred method in management patients with prior~     exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.~   "
118690|NCT01502384|"~     This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's~     Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for~     PD. The purpose of this study is to explore the association between genetic mutations in the~     known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and~     cognitive functions.~   "
118691|NCT01502371|"~     The primary objective of this study is to demonstrate the dose-related efficacy, by~     evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent~     predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of~     three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler~     (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,~     with persistent asthma. The primary hypothesis of this study is that at least one dose of MF~     MDI BID increases lung function, defined as a significant increase in percent predicted~     FEV1, when compared to Placebo.~   "
118692|NCT01502358|"~     The purpose of this study is to determine whether a new investigational dengue vaccine is~     safe, well-tolerated, and to see if an immune response against dengue disease will be~     generated.~   "
118693|NCT01502345|"~     The purpose of this study is:~      • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and~     pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device~      Secondary:~      • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and~     pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when~     administered with the TDS-IM electroporation.~   "
118694|NCT01502332|"~     The purpose of this study was to evaluate prospectively the impact of two protective~     mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw)~     after cardiac surgery. The study selected patients presenting signals of deficient gas~     exchange (PaO2/FIO2 < 250 at a PEEP [positive end expiratory pressure] of 5 cmH2O) in the~     immediate post-operative period. An aggressive alveolar recruitment protocol applying~     opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to~     the standard alveolar recruitment protocol of the institution, where an opening pressure of~     20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing~     period of four hours of controlled mechanical ventilation, the patients followed the routine~     weaning protocol and physiotherapy protocol of the institution.~   "
118695|NCT01502319|"~     The Consortium's overall mission can be summarized as follows; each function is developed~     with the goal of clear military relevance:~        1. Produce new scientific knowledge about suicidal behavior in the military that improves~          mental health outcomes for the investigators men and women in uniform.~        2. Use high quality research methods and analyses to address problems in policy and~          practice that have a direct impact on suicide-related and other mental health outcomes~          for military personnel.~        3. Disseminate Consortium knowledge, information, and findings through a variety of~          methods appropriate for decision makers, practitioners, and others who are accountable~          for ensuring the mental health of military personnel. This includes the rapid response~          function so that queries from decision makers and others to the Consortium are answered~          with speed and efficiency. Technical assistance and support for decision makers and~          others is an integral aspect of this Consortium function. This aspect of the Consortium~          will warehouse knowledge about suicidal behavior in general (e.g., from civilian and~          international sources as well as from military sources), so that military issues can be~          informed in a comprehensive manner.~        4. Train future leaders in military suicide research through experience within a~          multi-disciplinary setting for Ph.D. students and postdoctoral scholars interested in~          research questions on military suicide of both a basic and applied nature.~   "
118698|NCT01502280|"~     Gliomas are the most common primary brain tumor, yet remain a challenge to effectively~     treat. Mounting evidence suggests that survival improves with greater tumor removal, yet~     being able do a complete removal can be difficult due to the tumor's infiltrating nature.~     5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3~     hours before surgery, is selectively taken up by glioma cells and causes a red/pink~     fluorescence (glow) under a blue light that allows tumor margins to be seen during the~     course of surgery. While this compound is used as a standard-of-care agent in Europe, it~     remains under testing by the Food and Drug Administration (FDA). A recent clinical trial in~     Germany, however, has demonstrated a significant improvement in the rate of complete~     resection for certain brain tumors (65% vs. 34%).~      The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on~     the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special~     microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the~     tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the~     special microscope during surgery will greatly lower the amount of tumor left behind.~   "
118699|NCT01502267|"~     The purpose of this study is to determine whether high dose IVIG and B cell depleting agents~     can be used effectively in highly sensitized wait-listed patients.~   "
118700|NCT01502254|"~     The purpose of this study is to test if cancer patients who are informed about, and offered~     participation in a cancer clinical trial, are more knowledgeable about cancer clinical~     trials if they have access to an audio recording of their information visit.~   "
118701|NCT01502241|"~     The study aims to optimize the treatment of elderly subjects (> 65) with anaplastic~     astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative.~     There is no consensus as to how radical the surgery should be. Involved-field radiotherapy~     is the treatment most likely to be accepted apart from supportive and palliative measures.~     The role of chemotherapy is barely defined. Study data available to date does not suggest~     that this patient population would benefit from combined radiochemotherapy. The aim of the~     study is to verify the hypothesis that first-line chemotherapy with one week on/one week off~     temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of~     anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary~     endpoint is median survival, as life expectancy is limited to several months. Secondary~     endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median~     progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular~     genetic prognostic or predictive markers, and quality of life. Theoretically, it should be~     possible to preserve quality of life in the first-line chemotherapy arm of the study.~   "
118702|NCT01502228|"~     Given the growing importance of anti-angiogenic therapies in the treatment of metastatic~     renal carcinoma, it is expected that this trial will establish the preliminary data needed~     to apply for funding of a larger clinical investigation of the potential role of PET~     perfusion imaging in management of renal carcinoma, and potentially other cancers.~   "
118703|NCT01502215|"~     Blood transfusion during perioperative period in patients undergoing to major surgery has~     been associated to several postoperative complications. Particularly in oncologic surgery,~     red blood cell transfusion has been investigated as a factor of worse outcome and cancer~     recurrence due to postoperative impairment of cellular immunity. Although red blood cell~     transfusion has decreased in worldwide clinical practice, this issue still remains a matter~     of controversy in oncologic surgery. There are no prospective studies comparing outcomes~     between restrictive or liberal of blood transfusion strategy in oncologic surgery. This~     study is a prospective and randomized study comparing clinical outcomes between two~     strategies of transfusion in oncologic surgery - liberal or restrictive~   "
118704|NCT01502202|"~     Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle~     improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for~     never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.~   "
118705|NCT01502189|"~     The aim of this study is to explore whether an intensified informational intervention built~     upon the Representational approach framework can reduce stress in parents of children with~     cancer.~   "
118706|NCT01502176|"~     Retrospective observational study of patients with atrial fibrillation admitted to Roskilde~     University Hospital in 2010.~   "
118707|NCT01502163|"~     Although several measures for prevention of perioperative hypothermia have been introduced~     the last decades, perioperative hypothermia is still a frequent complication and associated~     with a negative outcome.~      For not long lasting surgery without specific risk for hypothermia the standard procedure~     for prevention of perioperative hypothermia is insulation. However, the insulation is often~     not effective enough to prevent intra- and postoperative hypothermia. The implementation of~     a prewarming is difficult because of variable OR schedules and therefore not often applied.~      In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a~     convective prewarming system on prevention of intra- and perioperative hypothermia~     (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced~     air warming with or without passive insulation before induction of anesthesia.~      The studied prewarming device is easy to use and will be applied on the nursery ward 30-60~     minutes before transfer of the patient to the OR.~      Perioperative hypothermia is a common complication in general aesthesia. Perioperative~     hypothermia is associated with medical risks as intraoperative impaired coagulation due to~     reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative~     blood loss. In the postoperative course the perioperative hypothermia is especially for~     patients with cardiopulmonary diseases a relevant problem. Not at least sensual cold and~     shivering is uncomfortable for the patient.~      The study is conducted as a multicenter, prospective, randomised controlled trial. All~     patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air~     ™). For one intervention group will additionally the insulation with the Thermoflect™ will~     be applied on nursery ward, the second intervention group will receive additionally a~     convective air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)~     preoperatively on study day on nursery ward.~      The aim of the study is to prove the hypothesis that a preoperative insulation with a~     commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower~     incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that~     an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated~     with a more less incidence of periopative hypothermia.~   "
118708|NCT01502150|"~     The goal of this research study is to collect information on the side effects of proton~     therapy and the details of proton treatment plans so that researchers can develop a method~     to predict the risk of side effects and to improve the planning and delivery of proton~     treatment for patients in the future.~   "
118709|NCT01502137|"~     This trial is conducted in Europe. The aim of this trial is to to compare steady-state total~     growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy~     subjects.~   "
118710|NCT01502124|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin®~     cartridges (liquid somatropin) in children with growth hormone deficiency.~   "
118716|NCT01502046|"~     Huntington's disease (HD) is a progressive neurodegenerative disorder, related to an~     abnormal expansion of CAG triplets in the huntingtin gene, characterized by motor, cognitive~     and behavioral abnormalities, without known effective symptomatic treatment and without~     known disease slowing strategy. The most severe neuropathological lesions observed in HD~     take place in the striatum, one brain area important in motor control and rich in~     cannabinoid receptors (CBR). CBR are subdivided in two classes: CB1R are located in neurons~     and play a role in neuronal function; CB2R in brain are located mostly in microglia and~     modulate neuroinflammation.~      CBR disappear early in the course of HD, before there is a massive drop out of cells in the~     striatum. Cannabinoid transmission is also an early event in brains of animal models of HD.~     In R6/2 mice, which carry large CAG expansions and develop an early and severe HD phenotype~     the suppression of the CB1R gene further accelerate the development of a severe clinical~     syndrome and the characteristic brain inclusions and abnormalities of synaptic density. R6/2~     treated mice treated with cannabinoids improve their clinical phenotype, their brain~     lesions, the synaptic density and the levels of BNDF, a neurotrophic factor which enhances~     survival and resistance of striatal neurons.~      Preliminary studies of cannabinoids in patients with HD have shown that these compounds are~     safe in these patients. Those studies, however, did not show efficacy because 1) they were~     underpowered from the statistical point of view, 2) were performed with isolated pure~     cannabinoids, instead of the more physiological stimulation with a mixture of compounds, and~     3) they did use insensitive clinical parameters instead of sensitive end points, such as~     pathogenically important biomarkers.~      The investigators propose a phase II trial with combination of cannabinoids with evaluation~     of safety, by the profile of adverse events, and efficacy, according to changes of important~     biomarkers~   "
118717|NCT01502033|"~     This research study aims to test the safety and effectiveness of repetitive transcranial~     magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how~     rTMS treatment affects the neurobiology of teens with depression.~   "
118718|NCT01502020|"~     Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic~     keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week~     treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod~     cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of~     clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding~     scalp.~      The current clinical study is designed to evaluate the therapeutic equivalence of this~     formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation~     (Graceway Pharmaceuticals LLC).~   "
118719|NCT01502007|"~     The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides~     feedback to subjects combined with an activity counseling program will result in an increase~     in physical activity of at least 20%.~   "
118720|NCT01501994|"~     The purpose of the study is to determine if providing physicians with a walking workstation,~     exercise counseling, and accelerometer feedback about activity will increase physician~     activity.~   "
118721|NCT01501981|"~     In this pilot, investigator-initiated multi-centre, multinational, observational study the~     investigators would like to examine the impact of therapy optimization on the level of~     biomarkers in patients with acute decompensated and decompensated chronic heart failure.~      The primary objective is to determine the best time point for measuring biomarker levels~     during therapy optimization in patients with decompensation to predict clinical outcomes~     such as mortality, hospitalisation, and quality of life.~      Secondary objectives are:~        1. To evaluate the impact of guideline-recommended medication on biomarker levels during~          and following recompensation.~        2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of~          relevance to guide medical therapy following decompensation.~        3. To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is~          of relevance with regard to hemodynamic stability and cardiovascular events such as~          hospitalisation.~        4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of~          relevance to guide medical therapy following decompensation.~   "
118722|NCT01501968|"~     Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.~   "
118723|NCT01501955|"~     The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal~     Hip Prosthesis (MHP) compared to the Stanmore hip replacement.~   "
118724|NCT01501942|"~     This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the~     efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable,~     mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a~     history of episodic wheeze and shortness of breath, will be eligible for enrollment.~      The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive~     product) with an allergen challenge on day 3 of dosing to see how the patient's lung~     function is changed by using AIM-102 or placebo.~   "
118725|NCT01501929|"~     The purpose of this study is to determine if Nebivolol improves microvascular perfusion in~     skeletal muscle during exercise in hypertensive patients and whether this improvement is~     accompanied by reduction in vascular oxidative stress or increased endothelial nitric oxide~     synthase (eNOS) expression in humans.~   "
118726|NCT01501916|"~     The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used~     to reduce atherosclerotic risk factors.~   "
118727|NCT01501903|"~     Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a~     growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80%~     of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple~     attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of~     the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails~     to sample the cancer cells. The fanning technique is a method where the needle moves in~     multiple directions within a mass and therefore there is a better chance of the cancer cells~     being sampled compared to the standard technique where the needle moves in only one~     direction. The diagnostic performance of both these techniques has not been compared in a~     randomized fashion.~   "
118728|NCT01501890|"~     The purpose of this study is to investigate whether treatment with progesterone for patients~     with first trimester vaginal bleeding will alter the rates of obstetrical complications and~     adverse pregnancy outcomes.~   "
118729|NCT01501877|"~     This study is designed to develop and test a smoking cessation intervention for smokers with~     Type 2 diabetes.~   "
118730|NCT01501864|"~     The purpose of this study is to test whether school support can keep adolescent Kenyan~     orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.~   "
118731|NCT01501851|"~     Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter~     and Thickness~   "
118732|NCT01501838|"~     The purpose of this study is to create a registry of patients with Pulmonary Hypertension~     who received medical care in the Hospital Italiano of Buenos Aires.~   "
118733|NCT01501825|"~     The Multiway stimulator is a novel TMS stimulator with several new and unique properties.~     Currently standard TMS devices include a single channel, and can operate only a single coil.~     The Multiway stimulator includes five channels which can operate up to five independent TMS~     coils, either simultaneously or sequentially.~      The Multiway device may be used to obtain a differential activation of various brain~     regions. For instance it can be used to induce high frequency stimulation of a certain brain~     region, thus inducing facilitation, while simultaneously stimulate at low frequency in~     another brain region, leading to inhibition.~      The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in~     comparison to a single channel DTMS treatment in subjects with MDD.~      Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS~     Device):~        1. Single Channel with a coil placed over the left PFC (10 Hz).~        2. Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over~          the left parietal cortex. d. 1 Hz over the right parietal cortex.~   "
118734|NCT01501812|"~     Learning includes the ability to generalize to new situations and respond to similar, yet~     not identical stimuli. In previous work, focused on stimulus generalization in healthy~     volunteers, tones that were negatively reinforced induce wider generalization curves than~     tones that were positively reinforced, and these in turn induce wider curves than neutral~     memory (Schechtman et al, 2010).~      The current study aimed to evaluate those patterns in different clinical disorders~     (including Schizophrenia, Bipolar disorder, MDD, Anxiety disorders (Panic and GAD) and PTSD,~     and healthy subjects that would be used as a control), with consideration whether those~     patterns are unique to any specific disorder or state.~      The generalization patterns evaluation would conduct twice though enable to compare the~     stability of those patterns during the course of the illness (i.e during remission compared~     to acute state).~      The basic paradigm based on conditioning of a tone (sound) with unpleasant noise, and~     extinction of that conditioning afterword. During the 60 minutes of evaluation, the~     capability to discriminate between the original tone and similar but not identical tones,~     and the tendency to categorize similar tones as identical to the original tone. A neutral~     tone without conditioning will be used as reference. The clinical diagnosis will conduct by~     a senior psychiatrist, and the state would be evaluated using standard questionnaires~   "
118735|NCT01501799|"~     EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES,~     L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris.~     Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl~     peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and~     efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.~   "
118736|NCT01501786|"~     Normal cardiac and respiratory functions should be maintained during pediatric cardiac~     catheterization. Propofol has become a popular choice for sedation in children, however, it~     depresses cardiac and respiratory functions. Some investigators reported that ketamine~     attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac~     and respiratory depression caused by propofol in pediatric cardiac catheterization.~   "
118737|NCT01501773|"~     A multi-centric initiative to study safety,feasibility and efficacy of using intravenous~     autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This~     phase of study is visualised as phase 2 study and will aim to determine dose response~     gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for~     autologous stem cell therapy in patient with acute ischamic stroke.~   "
118738|NCT01501760|"~     Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal~     opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed~     to reduce newascularization induced by gastric cancer or age-related macular degeneration. A~     few reports have been published showing the interest of VEGF inhibitors to treat corneal~     newvessels, but no randomized study has been achieved to date.~      This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal~     antibody, to reduce the surface of corneal newvessels in when compared to placebo~   "
118739|NCT01501747|"~     The total effect of a medication is the sum of its drug effect, placebo effect (meaning~     response of placebo), and their interaction. Current interpretation of clinical trials (the~     gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s)~     underlying such interaction have not been fully explored. One possibility is that the~     placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have~     recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life.~     Due to the novelty of this finding and its important clinical practice and clinical research~     implications, it needs to be confirmed in another set of subjects and extended to additional~     drugs.~      The results of the study are expected to further our understanding of the mechanism of~     action of a widely used medical intervention, i.e., placebo. The results will be important~     for both clinical practice and clinical research.~   "
118750|NCT01501604|"~     In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120~     as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase~     (PI3K)pathway, thereby inhibiting tumor growth and survival.~      The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth~     of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms,~     change in the size of your tumor, and laboratory findings obtained while you are on study~     will help the research team decide if BKM120 is safe and effective in patients with advanced~     cancers.~   "
118751|NCT01501591|"~     The total effect of a medication is the sum of its drug effect, placebo effect (meaning~     response of placebo), and their possible interaction. Current interpretation of the results~     of clinical trials (the gold standard in evidence based medicine) assumes no such~     interaction. Using a novel cross-over balanced placebo design and caffeine as a model drug,~     the investigators have recently shown that a negative interaction does exist; suggesting~     that the size of drug effect as currently measured by clinical trials may not be accurate.~     Due to the novelty of the findings and their important clinical practice and research~     implications, they need to be confirmed using another drug; and the size of drug effect~     measured using the novel design need to be directly compared to that measured using~     conventional clinical trial design. The results of the study are expected to further our~     understanding of a widely used medical intervention, i.e., placebo, and help assess the~     appropriateness of randomized clinical trials in determining the size of drug effect.~   "
118740|NCT01501734|"~     Successful treatment of pulmonary edema was first published in 1938 by A. L. Barach. Since~     then, this has been the accepted method of treating acute respiratory failure due to left~     heart failure and edema.~      The question was raised if pressure supported ventilation during sleep is used to eliminate~     sleep apneas, would it be useful also for improving congestive heart failure (CHF). Recent~     studies assessed the role of continuous positive airway pressure (CPAP) in patients with~     advanced CHF and found the treatment useful. A possible explanation for these results is~     that central sleep apnea frequently coexists with severe CHF and is not treated or~     suppressed by CPAP.~      The frequency of central sleep apnea increases with the severity of CHF and can be found in~     more than 30% of patients.~      A few recent studies showed the usefulness of bilevel positive airway pressure (BIPAP) or~     adaptive servo-ventilation (ASV). ASV led to improvement in ejection fraction as well as in~     6 min walking distance testing, and was associated with decreased BNP levels. In another~     study, bilevel PAP increased LVEF by 7.9%.~      The limitations of these studies are the small number of patients and that they were~     conducted on inpatients only. These factors make it difficult to include BIPAP in the~     guidelines for chronic heart failure therapy.~      Recently, two outpatient modalities have been introduced to diagnose sleep disordering~     breathing (SDB). However, no study has directly compared the results of both studies in~     patients with CHF. Moreover, no studies have assessed improvement in CHF after BIPAP~     treatment.~      In addition, the investigators plan to assess the endothelial function in this population~     before and after BIPAP treatment with the EndoPAT, a noninvasive technology~   "
118741|NCT01501721|"~     Objective: This study aimed to characterize the food intake and energy expenditure of school~     cooks and to evaluate the anthropometric and metabolic changes that occurred after a~     low-volume home-based exercise program.~      Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was~     conducted during the school year of 2007. The trial had a factorial design based on two~     different interventions: 1) nutritional counseling and 2) home-based exercise. The~     nutritional intervention was focused on decreasing the amount of sugar used in school meals~     by the cooks as well as decreasing their own sugar intake. The exercise program consisted of~     stretching and aerobic exercises that could be practiced at home, at least three times per~     week (40 minutes per session), with a low-to-moderate intensity.~   "
118742|NCT01501708|"~     In this prospective phase II observational study, we plan to assess the efficacy and~     tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in~     a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched~     unrelated donor or mismatched donor conditioning with ATG containing regimen or present~     III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.~   "
118743|NCT01501695|"~     The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric~     patients with tic disorders.~   "
118744|NCT01501682|"~     The purpose of this study is to compare the long-term complaints after ventral hernia repair~     after insertion of different types of mesh compared with primary suture. Also recurrence of~     hernia will be discussed.~   "
118745|NCT01501669|"~     This study is a multicenter, randomized study, open-label, phase III study.The efficacy of~     irinotecan and capecitabine combination will be superior to capecitabine alone in term of~     progression free survival in metastatic breast cancer patients previously treated with~     anthracycline and taxane.~   "
118746|NCT01501656|"~     Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular~     events in malignant transformation and is readily detectable in apparently normal benign~     breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA~     methylation of certain genes occurs as a field change in benign breast tissue that is at~     high risk for malignant transformation, and as such, can be exploited for tissue-based~     breast cancer risk stratification. Additional work is required to identify new DNA~     methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based~     breast cancer risk stratification, to determine whether these markers are methylated more~     frequently in benign samples from women who develop breast cancer, to determine whether~     assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA~     methylation, and to better understand the pattern of DNA methylation in benign samples from~     unselected healthy control populations. Each of these objectives contributes to advancement~     of a clinically useful RP-FNA-based breast cancer risk stratification test.~      In addition, identification of genes that are preferentially methylated in estrogen receptor~     (ER) negative breast cancer will provide clues to the underlying biology responsible for~     this aggressive form of breast cancer. This knowledge may lead to the discovery of the~     causes of ER negative breast cancer, approaches for recognizing women at increased risk for~     this type of breast cancer, and approaches for reducing this risk.~      This study seeks to identify patterns of DNA methylation in benign breast epithelial cells~     associated with an increased risk for breast cancer with a focus on ER negative breast~     cancer.~   "
118747|NCT01501643|"~     Acute chest syndrome is a severe respiratory complication of sickle cell disease.~      The standard prevention of this dangerous complication is spirometry in wich patient is~     required to take deep breaths trough a little device several times a day. This treatment is~     compromised when pain in important or when the patient is asleep and cannot participate.~      The investigators hypothesised that non invasive ventilation in wich patient have no effort~     to take might be a better prevention than spirometry and may improve pain and quality of~     sleep.~      Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly~     assigned with either spirometry or ventilation and the investigators will monitor for~     occurrence of acute chest syndrome, pain and quality of sleep.~   "
118748|NCT01501630|"~     Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer:~     diagnostic performance and impact on the patient management.Determine the lowest cost~     strategy according to the precise clinical circumstances.~   "
118749|NCT01501617|"~     The purpose of this study is to evaluate the safety and efficacy in relation to dosing in~     the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected~     intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).~   "
118793|NCT01501253|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy~     (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.~   "
118752|NCT01501578|"~     This study is an observational and retrospective study of patients with pulmonary fibrosis~     associated or not with telomerase mutation.~      The purpose of this study is to describe in detail the cases with telomerase mutation in~     terms of features on CT scan, respiratory function and evolution, in comparison to control~     subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family~     history.~   "
118753|NCT01501565|"~     The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12~     and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP)~     and patients under conventional analgesia. Also the opioid consumption is assessed.~   "
118754|NCT01501552|"~     The overall objective is to study if training and support, financial reimbursement and~     referral to an internet based brief intervention programme, singly or in combination, may~     increase implementation of evidence based methods of identification and brief intervention~     for excessive alcohol consumption in routine primary health care.~   "
118755|NCT01501539|"~     The primary objective of this study is to compare the incidence of postoperative~     hypergranulation tissue formation after gastrostomy tube placement among children randomized~     to one of three treatments, in addition to measuring tube dislodgements and rates of~     resource utilization for complications.~   "
118756|NCT01500564|"~     Previous research that utilises single sessions of transcranial direct current stimulation~     (tDCS) have demonstrated functional improvements. However these improvements are usually~     short-lived, lasting less than one hour before the patient's performance returns to~     baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing~     functional activation of pathologically under-active tissue or suppressing pathologically~     over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that~     tDCS can improve learning/memory functions in healthy controls. The goal of this study is to~     test if the application of tDCS could enhance learning and/or memory for physiotherapy~     rehabilitation, which may in turn lead to correspondingly greater motor improvement.~     Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily~     sessions of tDCS.~      This research has important implications; previous studies suggest that such an approach has~     the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a~     clinically viable rehabilitative tool. Recovery of motor skills may take many months to~     acquire and therefore strategies that have the potential to enhance acquisition of skill are~     of practical and scientific interest.~   "
118757|NCT01500551|"~     Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have~     previously participated in tofacitinib JIA studies.~   "
118758|NCT01500538|"~     Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has~     been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who~     have progressive, persistent or recurrent disease on or following two systemic therapies.~      In the early period of treatment with vorinostat, some patients may experience low platelet~     counts. Therefore this study will be examining the combination of these two medications~     (Vorinostat and eltrombopag) to assess if eltrombopag can overcome the low platelets during~     treatment with vorinostat.~      Eltrombopag is a drug administered orally designed to mimic the protein thrombopoietin,~     which causes the body to make more platelets. Eltrombopag has been registered in Australia~     and approved overseas to treat patients with chronic ITP (Immune Thrombocytopenia Purpura) a~     disease where patients destroy their own platelets very rapidly and thus develop low~     platelet count) but it is not registered and it is not yet known whether eltrombopag can~     increase platelet counts in patients treated with the HDACi.~      The aim of this project is to test whether Vorinostat and eltrombopag can be safely~     combined, and to test whether they are effective in participants with T-cell lymphoma~     involving the skin or patients with relapsed/refractory follicular lymphoma (FL), marginal~     zone lymphoma (MZL), or mantle cell lymphoma (MCL)~      A total of 25 people with Cutaneous T cell lymphoma/ CTCL, marginal zone lymphoma,~     follicular lymphoma or mantle cell lymphoma will be recruited in this study.~   "
118759|NCT01500525|"~     Objectives:~      Our goal is trying to identify an ideal BDR cutoff point for Chinese controller-naïve~     asthmatic children. In order to achieve this, several steps need to taken.~        1. To observe BDR distribution curve for Chinese non-asthmatic children from 4-12 years~        2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from~          4-12 years~        3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group,~          and analyze appropriate cut-off point value~      Hypothesis:~        1. Publications and our clinical experience indicate BDR value is affected by ethnicity,~          and children are less responded to bronchodilator compared with adult patients. From~          this aspect, data from Chinese children may be different from data included in the~          guidelines which mostly determined by studies in adults~        2. Reversible bronchospasm is a characteristic in asthma patients. Between asthmatics and~          non-asthmatics, different response to BDR test would be observed, and there would be a~          cutoff point with good sensitivity and specificity to differentiate asthmatics from~          non-asthmatics~      Background and rationale:~      According to the guideline of global initiative for asthma, global strategy for asthma~     management and prevention (GINA) and guideline of United States National Asthma Education~     and Prevention Program (NAEPP) guidelines spirometry, including baseline forced expiratory~     volume in 1 second (FEV1) and the bronchodilator response (BDR) to short acting beta~     agonists (SABA), should be used in children as objective measures to establish the diagnosis~     and severity of bronchial asthma. Spirometry is necessary because not every child came to~     the clinic with typical symptoms and the objective measurement can improve diagnosis~     confidence. Baseline FEV1, the so called gold standard for evaluating airway obstruction~     in adults, is usually in the normal range (greater than 80% predicted) in children,~     regardless of asthma severity. This substantially limits its value for diagnosis and~     assessment of response to treatment. Because of this, several other objective measures have~     been suggested for diagnosis and treatment in children, including the response to a~     bronchodilator, which reflects not only airway reversibility, but also a marker of airway~     inflammation.~      The current definition for a positive BDR is >12% reversibility and >200 ml increase from~     initial FEV1 after short acting beta-agonist (SABA) has been used. However, recent reports~     and our clinical observation revealed that, in a significant part of Chinese asthmatic~     children, their BDR value cannot achieve 12% in the evaluation.~      It has been suggested that the cutoff point of 12% is too conservative for pediatric~     patients. In the study carried out by Galant et al among 51 non-asthmatic children and 346~     controller naïve asthmatic children between 4-17 years, the BDR value could achieve 12% in~     only 30.6% asthmatic children, across all severity. Meanwhile, when observing BDR value in~     the above study, results were 2.2% (95% CI, 0.2-4.3) in the non-asthmatic group compared~     with 8.6% (95% CI, 7.5-9.8) in the asthmatic group. The range seen was 7.6% (95% CI,~     5.8-9.5) for mild asthma to 10.1% (95% CI, 7.6-12.6) in the severe persistent group. Also,~     in a study among 142 children between 5-10 years in UK, 9% increase in FEV1 after~     bronchodilator use was suggested as the cutoff point with good sensitivity and specificity.~     Moreover, in a study carried out among 3052 children in rural area between 8-15 years in~     Anhui Province in China, results showed BDR was 3 +/- 5% in non-asthmatic children, and 7~     +/- 9% in asthmatic children.~      Difference between the proposed study to be carried out in our hospital and the one in Anhui~     Province is that subjects in this proposed study are from 4-12 years old, which is the~     largest patient segment in our clinic including preschool and school students. And most~     importantly, the main purpose of study in Anhui is to observe the BDR range of the~     non-asthmatic children and asthmatic children, while in our study, besides this~     objective,our will tentatively calculate a BDR cutoff point by using receiver operating~     characteristic (ROC curve). And the cutoff point can be used as a reference indicator in~     asthma diagnosis and long-term management.~      The current BDR cutoff point of 12% that is not ideal for children can also be reflected in~     the clinical management. It has been shown that a persistent BDR value, even less than 12%,~     in asthmatic children suggests poor clinical outcome. In a 4 years study among 1041~     asthmatic children in America carried out by Sharma et al, it showed that compared with~     individuals who had a BDR of 12% and 200ml, individuals who had a BDR of 10% had similar~     poor clinical outcomes (e.g. more hospital visits, more prednisone bursts, increased~     nocturnal awakenings, and missing more days of school). Same results were also obtained in~     Galant et al study among 679 asthmatic children among 5-18 years.~   "
118760|NCT01500512|"~     This research trial studies patients with early-stage vulvar cancer undergoing sentinel~     lymph node dissection. Sentinel lymph node dissection may have fewer side effects than~     removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may~     help doctors confirm the safety of the procedure.~   "
118761|NCT01500499|"~     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in~     the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research trial studies the role of biomarkers in disease progression in~     samples from patients with acute myeloid leukemia.~   "
118762|NCT01500486|"~     This study is conducted in Europe. The aim of this study is to evaluate ease of injection of~     growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience~     and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device -~     is also evaluated.~   "
118763|NCT01500473|"~     Background: Congenital Central Hypoventilation Syndrome (CCHS) is a rare disorder of~     automatic control of breathing. This disease can manifest as early as birth. Patients with~     this disease have a fundamental lack of central drive breathing. They do not mount any~     responses to hypoxia or hypercapnia during sleep or wakefulness. This places them at risk of~     injury or death whenever they are not consciously breathing. They require lifelong assisted~     ventilation while sleeping, and some while awake. Progesterone is a known respiratory~     stimulant in normal individuals, and it has been shown in one study of 2 patients that this~     drug may improve CO2 responsiveness in patients with CCHS. However, this observation~     requires confirmation.~      Hypothesis: Exogenous progesterone (in oral contraception pills) will improve CO2~     responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity~     using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100%~     oxygen, and improve spontaneous ventilation during sleep in CCHS females >15-years of age.~     The progesterone will also depress ventilatory response using a hyperoxia test.~      Study Methodology: Baseline measures of CO2 and oxygen responsivity, and spontaneous~     ventilation during sleep, will be performed at baseline and after 3-weeks of taking a~     progesterone containing oral contraceptive agent. CO2 responsivity will be measured using a~     hyperoxic hypercapnic ventilatory response test. Hypoxic responsivity will be measured using~     a 5-breath 100% nitrogen breathing test. Hyperoxic responsivity will be measured by having~     subjects breathe 100% oxygen for 2-minutes. Subjects will perform an overnight polysomnogram~     to assess adequacy of gas exchange during spontaneous breathing while asleep. A progesterone~     containing oral contraception pill will then be given for 3-weeks, and the above measures~     repeated. Serum progesterone will be measured at baseline and at the time of study.~   "
118794|NCT01501240|"~     A prospective intra-individual study to investigate the diagnostic performance of gadoxetic~     acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as~     standard of reference~   "
118764|NCT01500447|"~     Background:~      - During puberty, children begin to develop into adults. Problems with the hormones released~     during puberty can affect the reproductive system. Some people have low hormone levels that~     severely delay or prevent puberty. Others start puberty abnormally early. Other people may~     have a normal puberty but develop reproductive disorders later in life. Researchers want to~     study people with reproductive disorders to learn more about how these disorders may be~     inherited.~      Objectives:~      - To learn how reproductive system disorders may be inherited.~      Eligibility:~        -  People with one of the following problems:~        -  Abnormally early puberty~        -  Abnormally late or no puberty~        -  Normal puberty with hormonal problems that develop later in life~        -  People who have not yet had puberty but have symptoms that indicate low hormone levels.~      Design:~        -  Participants will provide a blood sample for testing. They will complete a~          questionnaire about their symptoms. They will also have a scratch-and-sniff test to~          study any problems with their ability to smell.~        -  Participant medical records will be reviewed. Participants will also provide a family~          medical history.~        -  Family members of those in the study may be invited to participate.~        -  Treatment will not be provided as part of this study.~   "
118765|NCT01500434|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.~   "
118766|NCT01500421|"~     This study is designed to investigate the safty and feasibility of therapeutic hypothermia~     in acute stroke patients. Soon after arrival in the stroke unit patients are randomized to~     either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke~     ward.~      Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at~     temperature of 33 degrees for a period of 24 hours.~   "
118767|NCT01500408|"~     Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the~     active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This~     bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and~     pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved~     serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing~     process.~   "
118768|NCT01500395|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of~     different hybrid operations who had complex aortic lesions, such as ascending aortic/arch~     aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B~     dissection, dissection with primary tear located in the aortic arch, et al.~   "
118769|NCT01500382|"~     The study is designed to investigate the effects of the investigational drug vibegron~     (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive~     bladder. The study will also evaluate the safety and tolerability of multiple oral doses of~     vibegron in women with overactive bladder. Overactive bladder is best described as urgency~     and frequency of urination, with or without involuntary urination and/or the need to awaken~     during the night to urinate.~      The primary efficacy hypothesis is that vibegron is superior to placebo with respect to~     change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e.,~     steady state) in participants with overactive bladder. A true mean increase~     (vibegron/placebo) of 25% in bladder volume is expected.~      The primary safety hypothesis is that administration of multiple oral doses of vibegron is~     sufficiently well-tolerated in participants with overactive bladder, based on assessment of~     clinical and laboratory adverse experiences, to permit continued clinical investigation.~   "
118770|NCT01500369|"~     Atrial fibrillation is the most common arrhythmic complication after coronary artery bypass~     grafting (CABG). Post operative atrial fibrillation (POAF) increases morbidity and~     mortality. Inflammation could be a factor in POAF and recent evidence of remotely inducing~     ischemia may reduce inflammation and cardiac injury. The investigators plan to use a blood~     pressure cuff on the arm as a method to produce remote ischemia and assess the occurrence of~     POAF for seven day.~   "
118771|NCT01500356|"~     The primary aim of this study is to examine the effect of the consensus public health~     recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk]~     versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in~     the context of a comprehensive behavioral weight loss program that a includes a reduction in~     energy intake measures of cardiovascular function using cardiac MRI and biomarkers of~     vascular disease risk. Each of these exercise doses will be compared independently to a Diet~     Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also~     compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults~     who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA)~     for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary~     outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic~     volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected~     adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body~     weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors~     (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for~     examination of the effects of physical activity independent of weight change on the primary~     and secondary outcomes.~   "
118772|NCT01501526|"~     Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the~     first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host.~     The investigators case highlights the importance of performing a detailed laryngoscopic~     examination in any patient with prolonged husky voice.~   "
118773|NCT01501513|"~     The objective of this study is to compare the safety, tolerance and efficacy of BLI800~     (approved and investigational regimens) to an approved control preparation as bowel~     preparations prior to colonoscopy in adult patients, particularly including the elderly and~     those with renal and/or hepatic impairment.~   "
118791|NCT01501279|"~     The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck~     and proximal urethra. Pain management during transurethral procedures is a major~     concern.Patients who have been catheterized under anesthesia complained of urgency in the~     postoperative period because of catheter-related bladder irritation. We want to investigate~     that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort~     in transurethral prostatectomies~   "
118774|NCT01501500|"~     The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A~     (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by~     binding presynaptically to high-affinity recognition sites on the cholinergic nerve~     terminals and decrease the release of acetylcholine, causing a neuromuscular blocking~     effect. The investigators hypothesize that BTA injection may help to decrease the hallux~     valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the~     therapeutic result of hallux valgus treated with total contact insole. The outcome~     measurement may shed light in treating patient with painful hallux valgus and document~     evidence for plantar pressure changes in acute, sub-acute and chronic stage.~   "
118775|NCT01501487|"~     Genomics assays that measure specific gene expression patterns in a patient's primary tumor~     have become important prognostic tools for breast cancer patients. This study is designed to~     test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and~     TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict~     responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer~     (LABC).~   "
118776|NCT01501474|"~     Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant~     Biliary Strictures~      Objectives~        1. To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant~          biliary stricture diagnosis~        2. To assess the sensitivity, specificity and accuracy of Fluorescent in situ~          Hybridization(FISH) in malignant biliary stricture diagnosis~      Study design One academic center, prospective, diagnostic study~      Research Methodology Target population: Patients who are diagnosed malignant biliary~     stricture. Sample population: Patients who are diagnosed malignant biliary stricture in~     Chulalongkorn Hospital~   "
118777|NCT01501461|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the health of patients with human frailty syndrome.~   "
118778|NCT01501448|"~     The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF~     cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to~     equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be~     as good as the pill. The investigators will compare OCP vs oral estrogens to plan the~     initiation of IVF cycles.~   "
118779|NCT01501435|"~     To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra~   "
118780|NCT01501422|"~     1. Sex hormone including estrogen have synergistic effect to serotonin activity and~          decrease activity of monoamine oxidase activity so the norepinephrine is not be~          metabolized, these substance are important to regulate hemostasis and circadian process~          of sleep~        2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion~             -  GABA substance is in order to initiate sleep and continue sleep~        3. According to epidemiologic data, problem of sleep was increasing in postmenopause group~          compare to premenopause group (aged-match)~        4. This research perform to find out the actual effect of estrogen in improving sleep~          quality.~   "
118781|NCT01501409|"~     Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole~     surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa~     and skin and results in many side effects. This study was to compare the effects of SLS-free~     dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis~     (RAS).~   "
118782|NCT01501396|"~     This randomized phase II trial studies the safety and efficacy of megestrol acetate given~     with or without mirtazapine in treating cancer patients with weight loss and loss of~     appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer~     anorexia-cachexia syndrome (CACS). Megestrol acetate has been shown to increase appetite in~     cancer patients. Adding mirtazapine may provide a much more effective treatment and help~     improve quality of life.~   "
118783|NCT01501383|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in~     subjects with treatment-resistant partial epilepsy.~   "
118784|NCT01501370|"~     Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents.~     Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known~     human class I and II HDACs. HDACs have many protein targets whose structure and function are~     altered by acetylation, including histones and non-histones proteins component of~     transcription factors controlling gene expression and proteins that regulate cell~     proliferation, migration and death (1). Vorinostat has undergone initial evaluation in~     several phase I and II clinical trials in both solid and hematologic malignancies. It has~     shown activity in hematologic malignancies including Hodgkin's disease and non Hodgkin's~     lymphomas (2-5); it has been approved for treatment of cutaneous manifestation in patients~     with primary cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease~     on or following two systemic therapies (6). HDAC function is critical for Multiple Myeloma~     (MM) cells by actively maintaining a transcriptional program indispensable for their~     uncontrolled proliferation and/or inappropriate resistance to pro-apoptotic stimuli. The~     pleiotropic anti-MM effects of Vorinostat and its ability to sensitize MM cellsto multiple~     conventional or novel agents (7) provide the framework for clinical trials of Vorinostat in~     MM. A phase I trial of oral Vorinostat alone in advanced MM shows modest activity, but~     treatment was generally well tolerated (common drug related adverse events (AEs) included~     fatigue, anorexia, dehydration, diarrhea and nausea and were mostly grade < 2) (8). A phase~     I clinical trial of Vorinostat in association with Bortezomib in relapsed MM patients report~     a partial response (PR) rate of 42%, with responses occurring also in patients refractory to~     a previous Bortezomib based regimen. Treatment was generally well tolerated (main adverse~     events were myelosuppression, fatigue and diarrhea) (9). Lenalidomide is an active agent~     against MM, that as shown activity in both the relapse and newly diagnosed settings, in~     combination with chemotherapy or steroids only. The dose of Lenalidomide commonly used in~     the relapse setting, in association with steroids, is 25 mg/day on days 1-21 every 28 days~     (10, 11). A recent phase I study evaluated the safety and tolerability of Vorinostat in~     combination with Lenalidomide and Dexamethasone in relapsed patients:no dose limiting~     toxicities prohibited dose escalation, the maximum tolerated dose has not been reached and~     the maximum administered dose was Lenalidomide 25 mg/day on days 1-21, Dexamethasone 40~     mg/day on days 1,8,15,22, Vorinostat 400 mg/day on days 1-7 and 15-21; each cycle was~     repeated every 28 days. Rate of at least PR was 51%, and activity was seen also in patients~     who received prior Lenalidomide therapy (clinical benefit reported in 69% of patients,~     including minimal response or better in 33% of Lenalidomide refractory patients). The most~     common drug related grade > 3 AEs were neutropenia, thrombocytopenia, diarrhea, anemia and~     fatigue (12). Since Vorinostat has shown efficacy also in patients previously treated with~     Lenalidomide, and in patients refractory to Lenalidomide, the investigators hypothesis is~     that the addition of Vorinostat and low-dose dexamethasone to Lenalidomide (ZLd), in~     patients experiencing a biochemical relapse during a Lenalidomide maintenance ongoing~     therapy, can overcome Lenalidomide-drug resistance and result in a significant response~     rate, that can translate into a significant improvement in survival of MM patients. The~     second hypothesis is that, since the dose of Lenalidomide commonly administered in~     maintenance therapy, is 10 mg days 1-21 every 28 days, the increase in Lenalidomide dose to~     the standard dose used for relapsing patients, plus low-dose Dexamethasone (Ld), in patients~     experiencing a biochemical relapse during a Lenalidomide ongoing maintenance, can as well~     overcome Lenalidomide-drug resistance and determine a significant response rate, that can~     translate into a significant improvement in survival of MM patients.~      This is a multicenter non comparative, randomized, open label, phase II study. Patients, who~     are receiving Lenalidomide maintenance treatment with or without prednisone, will be~     randomized to receive:~      Cohort 1: ZLd association:~      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Vorinostat orally at~     the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.~      Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.~      Cohort 2: Ld association:~      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Dexamethasone orally~     at the dose of 40 mg day 1,8, 15, 22 every 28 days.~      Patients must have a -confirmed diagnosis of relapsed multiple myeloma. In this Phase II~     study, a total of up to 35 patients in the ZLd cohort and 48 in the Ld cohort will be~     enrolled. It is anticipated that full accrual to this study will take approximately 36~     months.~   "
118785|NCT01501357|"~     The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique~     compared with anteroposterior and biofilm removal and control of caries lesions in first~     permanent molars.~   "
118786|NCT01501344|"~     This study will determine if daily oral intake of 200g of a marketed yogurt with fortified~     calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in~     postmenopausal women. The efficacy of the product is measured by examining the variation of~     biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it~     has been added to the yogurt provided for this study. The effects of MBP 80 on the quality~     of bone tissue have not yet been proven.~   "
118787|NCT01501331|"~     The Boston Scientific Energen family is capable of measuring the respiratory rate trend~     (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This~     may result in early detection of imminent decompensation at a presymptomatic stage. The~     study will assess the respiratory trends correlation with clinically relevant heart failure~     events.~   "
118788|NCT01501318|"~     The investigators seek to develop a more efficient and effective approach to providing brief~     behavioral health interventions for risky substance use behaviors by comparing a brief coach~     directed intervention to a tailored report only group.~   "
118789|NCT01501305|"~     Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment~     in children.~   "
118790|NCT01501292|"~     Cytoplasmatic maturation is an important event in the general maturation of of the oocyte.~     Mitochondria is one of the major organelles involved in the process of cytoplasmatic~     maturation. The aim of this study is to investigate the presence and distribution of the~     mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine~     in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will~     not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to~     these immature oocytes the investigators shall also investigate the mitochondria in mature~     oocytes that underwent ICSI but did not become fertilized and are discarded.~   "
118792|NCT01501266|"~     The purpose of this study is to confirm the safety profile such as the frequency of serious~     adverse events or any unexpected adverse events and overall efficacy of Faslodex for long~     term treatment in daily clinical practice.~   "
118795|NCT01501227|"~     Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care~     patients as they may cause the death of the patient or prolong the intensive care stay or~     complicate the illness in other ways. The risk of infection is dependent on the interplay~     between bacteria load into the lungs and the immune status. There has been a lot of focus on~     bacteria load reduction and this includes the use of subglottic suctioning in an attempt to~     reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were~     designed to allow subglottic suctioning was significantly effective in reducing the~     incidence of ventilator associated pneumonia compared to normal tubes. A new generation of~     endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug~     fit into the tracheal by a new tapering design may be even more useful to provide the~     solution for bacterial load reduction. Conventional tubes which may furrow on themselves to~     allow the creation of microchannels may aid microaspiration. The taper guard which has~     facilities for subglottic suctioning as well as the strategy to reduce furrowing to the~     minimum may be the answer to the problem of ventilator associated pneumonia. This study is~     to determine the extent of protection this tube has against ventilator associated pneumonia~     compared with conventional endotracheal tubes~   "
118796|NCT01501214|"~     The hypothesis of this randomized double blind study is that the live birth rates are~     significantly higher after the use of atosiban prior to the embryo transfer in patients~     undergoing in vitro fertilization (IVF) treatment. This study aims to compare the live birth~     rates of IVF treatment between patients receiving atosiban and placebo prior to the~     transfer.~   "
118797|NCT01501201|"~     The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized~     medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of~     mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost~     utility of these two strategies.~   "
118798|NCT01501188|"~     The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius~     muscle activation during gait and on Range of ankle motion in postmenopausal females with~     Chronic Venous Insufficiency in initial stages in comparison to a placebo control group.~   "
118799|NCT01501175|"~     To date, the investigators still do not know the annual incidence of Superficial Vein~     Thrombosis in the legs, although the investigators do know that this pathology is frequent~     and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is~     of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with~     concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so~     it is important to re-evaluate this rate on an unselected population from general practice.~   "
118800|NCT01501162|"~     Background/Aims:~      The investigators explored the therapeutic effects of probiotics in patients with AH.~      Methods:~      Between September 2010 and April 2012, the investigators conducted a 7-day,~     double-controlled, randomized, prospective clinical trial comparing the efficacy of~     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an~     aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)~     level with an alcohol consumption history within 48 hours. Patients were randomized to~     receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified~     Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline~     and again after therapy.~   "
118801|NCT01501149|"~     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment~     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural~     Killer (NK)/T Cell Lymphoma.~   "
118802|NCT01501136|"~     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment~     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage~     I/II Natural Killer (NK)/T Cell Lymphoma.~   "
118803|NCT01501123|"~     PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)~        -  The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the~          sedation of agitated patients in the prehospital environment~        -  The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1~           o The RASS is a well validated standardized score to measure a patient's agitation~        -  The secondary outcomes are~             -  Time until RASS returns to 0 or 1 if RASS <0~             -  Need for additional sedation~             -  Adverse effects (need for intubation, arrhythmia)~        -  Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying~          haloperidol~        -  Identification of potential study patients will be per state protocols~        -  Exclusion Criteria for the study~        -  Age <18~        -  Pregnant~        -  Allergic to study medication~        -  Transport to hospital other than Mercy Fitzgerald Hospital~        -  Unable to reach medical command prior to giving medication~        -  When a paramedic identifies a possible study candidate, the paramedic will consult~          medical command to see if the patient is appropriate for the study~        -  If the medical command agrees the patient is appropriate for the study, patients will~          be randomized to~        -  Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)~        -  Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age~          ≥65)~        -  The RASS will be documented by the prehospital providers every 5 minutes until arrival~          at the hospital~        -  Once the patient arrives at the ED, the RASS will be documented in PICIS® by the~          emergency department nurse at the time of triage and at a minimum of hourly until the~          RASS =0 or 1 for 2 consecutive hours~        -  Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267)~          205-6453~      Richmond Agitation Sedation Scale~      RASS RASS Description~        -  4 Combative, violent, danger to staff~        -  3 Pulls or removes tube(s) or catheters; aggressive~        -  2 Frequent non-purposeful movement~        -  1 Anxious, apprehensive, but not aggressive 0 Alert and calm~             -  1 Awakens to voice (eye opening/contact) >10 sec~             -  2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec~             -  3 Moderate sedation, movement or eye opening. No eye contact~             -  4 Deep sedation, no response to voice, but movement or eye opening to physical~               stimulation~             -  5 Unarousable, no response to voice or physical stimulation~   "
118804|NCT01501110|"~     The propose of this study is to determine whether N-acetylcysteine is effective in reversing~     the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.~   "
118805|NCT01501097|"~     The purpose of this study is to determine if early application of CRRT will result in an~     improvement of clinical outcomes of burn patients during the early phase of sepsis~   "
118817|NCT01500941|"~     Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and~     prevention but their precise role is not yet clear.~      The aim of this randomized double blinded active treatment vs placebo study was to evaluate~     clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius~     LS01 and Bifidobacterium breve BR03) for the treatment of adult AD patients.~      The rationale for the use of probiotics in the treatment of atopic dermatitis would be due~     to some experimental hypotheses:~        1. The use of these microbial agents at an early age seems to play an important role in~          inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE~          mediated~        2. the normal intestinal flora (including probiotics) would play an important role in~          inducing immunological tolerance~        3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2~          response T and the development of allergic diseases~   "
118806|NCT01501084|"~     Obesity is a major health problem in the US and many Western countries, with more than half~     of the population being overweight or obese. Yet, despite intense research efforts into the~     mechanisms underlying obesity and into the development of novel pharmacologic interventions,~     bariatric surgery, including gastric bypass surgery is the only successful treatment for~     severe obesity. Mimicking one of the effects of bariatric surgery, e.g. the increased~     secretion of glucagon-like peptide 1 (GLP-1) could be an effective strategy against obesity.~      Obese individuals may be more sensitive to the rewarding aspects of food and less responsive~     to signals from the gut about actual energy needs. Using functional MRI scanning the~     investigators plan to examine the effect of Exenatide (a GLP-1 analog known to reduce~     caloric intake and produce weight loss in both obese and lean individuals) on activity~     within brain regions/networks involved in reward/motivation and in regulation of energy~     requirements. The investigators expect the peptide to change the balance between desire to~     eat for pleasure and the need to eat to maintain homeostasis.~   "
118807|NCT01501071|"~     Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic~     Nissen fundoplication became the standard surgical treatment of this disease. Although being~     almost transient postoperative dysphagia is still a common complaint following this~     procedure. The aim of this study is to investigate the effect of inserting a soft structured~     and blunt mounted 39 F orogastric tube to postoperative dysphagia.~   "
118808|NCT01501058|"~     This study aims to develop a parent-assisted social skills training program for adolescents~     with autism spectrum disorder(ASD) and verify therapeutic effects of the program through~     case-control study.~        1. Both the case and the control of this study shall be a high-functioning group~          consisting of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total~          of 40 adolescents will be recruited and divided into two groups of twenty. One will be~          the case group and the other will be the waitlist control group. Again, the case will~          be divided into two sub-groups of ten and carry out this new developed program for both~          parents and adolescents. That is, the program will be carried out two times in each of~          both groups. The waitlist control group will be allowed to receive personal outpatient~          treatment and general therapeutic intervention from community while waiting.~        2. Effects of the program will be measured both at the case and the control by using a~          scale which measures social interaction, quality of peer relationship, disposition of~          autism and social anxiety. Equal assessments for both the case and the control will be~          conducted right before the beginning of the program and right after the completion of~          the program and some of the survey will be retried in order to see mid- and long-term~          effects three months after the completion of the program.~   "
118809|NCT01501045|"~     While some indications of the neural circuits involved in the Conditioned Pain Modulation~     (CPM) process are now available, there is still need to clarify what parts of the brain are~     essential for this process, whether the spino-brainstem loop is largely sufficient to~     explain CPM or whether other cerebral and spinal regions such as frontal, somatosensory and~     other cortical regions contribute substantially. Whereas mere observation of correlation~     between these circuits while activated by brain imaging is still of considerable interest,~     direct experimental manipulations by repetitive transcranial magnetic stimulation (rTMS)~     could even establish insights into causal relationships.~   "
118810|NCT01501032|"~     The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas~     system)automated insulin management system using continuous glucose monitoring (CGM) and~     subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will~     include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus~     meal, under-bolus meal and exercise.~   "
118811|NCT01501019|"~     Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren,~     Myositis and Takayasu's Arteritis.~      Therefore, this study aims to investigate the role of an exercise training program in~     patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.~   "
118812|NCT01501006|"~     The purpose of the study is to improve patient-physician communication and clinical~     decisions in the context of serious illness that may affect important clinical outcomes. The~     investigators will examine how variations in communication patterns and clinical decisions~     are affected by patient demographics (e.g age, sex), patient interactional style (e.g.~     communication behaviors) and physician characteristics (e.g. attitudes, background,~     training).~   "
118813|NCT01500993|"~     This study compares capecitabine with standard 5-FU in the perioperative treament of locally~     advanced rectal cancer.~   "
118814|NCT01500980|"~     The purpose of this study is to determine if sterile, protective immunity to malaria can be~     induced by malaria parasite exposure limited to the early liver stage of the parasite~     lifecycle.~   "
118815|NCT01500967|"~     Neck pain and related problems occur frequently in modern societies and have a considerable~     impact on individuals and the society. Cervical radiculopathy (CR) generally presents with~     pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a~     nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral~     disc herniation. Various studies have shown that nonoperative management for CR is~     effective, such as medications, physical therapy, Spinal manipulation, traction,~     acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is~     one of the manual techniques for treating mechanical neck pain. No high-quality evidence has~     proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy.~     However, limited evidence suggests that manipulation may provide short-term benefit in the~     treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications,~     such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal~     massage manipulation is used for centuries in China. Many patients with cervical disc~     disease are increasingly turning to manipulations to alleviate their symptoms and reduce the~     side effects of medications. The goal of this study is to determine the efficacy of a spinal~     manipulation, three steps and nine manipulations, on treating with the cervical~     radiculopathy.~   "
118816|NCT01500954|"~     MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a~     variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is~     very limited and microarray based genome wide miRNA expression profiles of cSCC have not~     been investigated so far.~   "
118819|NCT01500915|"~     The purpose of this study is to investigate the safety and efficacy of a combined~     fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the~     treatment of exudative age-related macular degeneration (AMD) in patients with good visual~     acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be~     achieved with fewer injections, even in patients with good VA.~   "
118820|NCT01500902|"~     The purpose of this study is to determine if testing patients for endothelial dysfunction~     will help identify which patients are more likely at risk to have another heart attack in~     the future. Study participants will undergo mental stress testing while at the same time~     being connected to a device that measures endothelial function via the Endopat device. These~     same participants will also undergo a sleep study via the Watchpat device.~   "
118821|NCT01500889|"~     The investigators compared conventional lateral internal sphincterotomy (CLIS), V-Y anal~     flap, and combined tailored lateral internal sphincterotomy with V-Y anal flap (TLIS with~     V-YF) in a randomized prospective study in patients undergoing treatment for chronic anal~     fissure.~   "
118822|NCT01500876|"~     Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning~      External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation~     therapy~      Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment~      Primary objectives: To assess pre-treatment global and focal lung strain and correlate with~     changes post-treatment~   "
118823|NCT01500863|"~     Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in~     women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides~     adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS)~     still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are~     used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.~      By testing different luteal support protocols on women undergoing GnRHa triggering, the~     investigators aim to find out which protocol resembles the most the gene expression profile~     observed after hCG triggering and conventional luteal phase support, in order to choose it~     as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).~   "
118824|NCT01500850|"~     The aim of this study is to observe changes in cardiovascular biomarkers during treatment~     with Lantus in patients with Type 2 Diabetes mellitus.~   "
118825|NCT01500837|"~     Background:~      One of the leading causes of peri-operative osteoarticular infections (OAI) is~     Staphylococcus aureus. Treatment usually requires surgical debridement in association with~     appropriate antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is~     routinely indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In~     this protocol, the latter includes clindamycin in combination with rifampin or levofloxacin.~     Clindamycin is considered a good option in staphylococcal infections, because of its action~     against biofilm formation and bacterial adherence, its high level of joint and bone~     penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances~     the elimination of a large number of drugs. Therefore, an influence of rifampin on~     clindamycin pharmacokinetics must be considered.~      Objectives:~      The primary objective is to compare the influence of rifampin and levofloxacin respectively~     on the pharmacokinetics of clindamycin in a randomized series of peri-operative~     staphylococcal OAI. The investigators then seek to determine the optimal drug association~     with regard to infection control and drug tolerance.~      Study design:~      Monocentric, randomized, open label, comparative study~      Study period:~      From November 2010 to October 2011.~      Materials and Methods:~      Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are~     randomly assigned either to the clindamycin/rifampin arm either to the~     clindamycin/levofloxacin arm, according to the antimicrobial susceptibility testing. Peak~     and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of~     oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same~     intervals to monitor patient compliance.~   "
118826|NCT01500824|"~     This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East~     Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event~     involving the ALK gene locus who have received only one prior chemotherapy regimen for~     advanced NSCLC and this regimen must have been platinum-based. Primary objective of this~     study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary~     objectives are to evaluate clinical efficacy including median progression-free survival~     (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12~     weeks, time to response (TTR), and duration of response (DR).~   "
118827|NCT01500811|"~     Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and~     soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There~     are treatments available to help manage these symptoms like weight loss, and analgesics.~     Surgery is the appropriate treatment in patients who have failed these conservative~     treatments. The aim of this clinical study is to assess safety of autologous cultured~     chondrocyte intra-articular injection and obtain its clinical results in patients with~     severe hip osteoarthritis.~   "
118828|NCT01500798|"~     This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone~     methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less~     than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for~     evaluation of the primary endpoints.~   "
118839|NCT01500655|"~     The purpose of this study is to determine whether either a peripheral nerve block under~     ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s~     guided block of the nerve followed by continuous catheter infusion of local anesthetic,~     offers better post-operative analgesia in pediatric burn patients undergoing reconstructive~     surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration.~      Eligible subject, pediatric patients having reconstructive surgery for burns, having skin~     graft donor sites of the lateral thighs, will be randomized into three groups: control~     (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided~     nerve block with catheter placement --fascia iliac.~      Post-operative comfort will be assessed over the next 48 hours.~   "
119435|NCT01492569|"~     This randomized pilot clinical trial studies giving acupuncture in reducing nausea and~     vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an~     acupuncture point on the inside of the wrist may help control nausea and vomiting during~     chemotherapy.~   "
118829|NCT01500785|"~     Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary~     artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial~     dysfunction. It has been suggested that the mechanism responsible for the contractile~     depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium.~     Levosimendan is a calcium sensitizer, which has been shown to improve the function of~     stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation~     and need of vasoconstrictive medication is usually apparent after administration of~     levosimendan. Colucci et al have demonstrated that with intracoronary administration of~     milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with~     levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without~     afterload reduction by adding levosimendan into cardioplegia solution.~      The investigators hypotize that levosimendan, delivered together with cardioplegia, can~     improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic~     valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac~     output 15 min after separation from cardiopulmonary bypass compared to the baseline.~     Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after~     sternal closure and cTnT/CK-MB on the first postoperative morning.~   "
118830|NCT01500772|"~     This study is to evaluate the overall efficacy, and safety profile of the triple combination~     therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV)~     patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a~     protease inhibitor (PI).~   "
118831|NCT01500759|"~     Objective target of the registry is to investigate the prevalence of SDB as well as the~     clinical characteristics of patients with and without SDB as well as the predominant type of~     sdb.~      For this purpose data from patients suffering from chronic, symptomatic heart failure with~     impaired left ventricular ejection fraction will be collected prospectively.~   "
118832|NCT01500746|"~     This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial~     counts in chronic wounds.~   "
118833|NCT01500733|"~     Background:~      - Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood~     or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white~     blood cells that hurt the immune system and make it more difficult to fight infections.~     These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL~     are over age 70. Elderly people often do not respond well to standard chemotherapy for~     CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition,~     individuals who have a genetic abnormality called 17p deletion also do not respond well to~     standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug,~     PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups.~      Objectives:~      - To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and~     people with 17p deletion.~      Eligibility:~        -  Individuals over 65 years of age who have CLL/SLL.~        -  Individuals at least 18 years of age who have CLL/SLL and 17p deletion.~      Design:~        -  Participants will be screened with a medical history, physical exam, and imaging~          studies. Blood and urine samples will be taken. Optional bone marrow and lymph node~          biopsies may also be taken.~        -  Participants will take PCI-32765 capsules every day for 28 days (one cycle of~          treatment). Treatment will be monitored with frequent blood tests and clinic visits.~        -  PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug~          will continue to take it as long as there are no side effects and the disease does not~          progress. Those who do not benefit will stop treatment and have regular followup exams.~   "
118834|NCT01500720|"~     Primary Objective:~      To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to~     topotecan in participants with sensitive or resistant/refractory small cell lung cancer~     following a first line platinum based chemotherapy.~      Secondary Objectives:~        -  To assess disease progression free rate at 12 weeks~        -  To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and~          duration of response~        -  To assess Overall Survival (OS)~        -  To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC]~          version 4.03)~        -  To assess the Health-Related Quality of Life (HRQoL)~   "
118835|NCT01500707|"~     This study is being done to assess the pharmacokinetics of SCH 900800 in participants with~     moderate to severe Parkinson's Disease (PD) being treated with L-DOPA.~   "
118836|NCT01500694|"~     For subjects in Europe that have already participated in either Study SPD503-315 or~     SPD503-316. This is an extension study that will allow participants access to~     Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the~     sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl~     (SPD503).~   "
118837|NCT01500681|"~     Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is~     associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical~     relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly~     used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance~     PLEX) is sometimes used to prevent relapses. This observational registry will record~     feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX~     for NMO.~   "
118838|NCT01500668|"~     Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive~     drugs such as amines. Finger necrosis (so called blue toe syndrome) is a well documented~     phenomena with incidence reaching as high as 60% in patients receiving vasopressin.~     Botulinum toxin is a known muscle relaxant used for a variety of medical application.~     Recently, several reports have demonstrated its effect in vasospastic disorders. It has also~     been in mice that when administered locally it has a local vasodilatory effect. The goal of~     this experiment is to compare the effect of Botulinum Toxin administered locally on amine~     induced finger necrosis.~   "
118840|NCT01500642|"~     The dose and the mode of administration of sublingual therapy remain open questions to~     determine the efficacy and safety of this desensitization therapy, the main purpose of this~     study is to evaluate if different routes of administration (oral-vestibular vs. sublingual)~     and a maximum dose of allergen administered are able to determine a different effect or a~     different incidence of side effects of the therapy in a group of patients with~     rhinoconjunctivitis and/or asthma due to ragweed~   "
118841|NCT01500629|"~     The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms~     of allergic rhinitis (hayfever). Subjects' participation in the study will last~     approximately 4 to 6 weeks, and each of three study visits during that time will last a few~     hours. Subjects will be required to have several tests done including allergy and breathing~     tests. They will be exposed to the item they are allergic to and will have small paper discs~     put in their noses. Subjects will also have the inside of their noses examined and will be~     asked questions about the level of their allergy symptoms.~   "
118842|NCT01500616|"~     The purpose of this study is to collect safety and tolerability data on telaprevir treatment~     in combination with Peg‑IFN‑alfa and RBV in patients with HIV/genotype 1 chronic HCV~     coinfection with severe fibrosis or compensated cirrhosis who are not eligible for~     enrollment into an ongoing clinical study of telaprevir.~   "
118843|NCT01500603|"~     Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have~     been presented as efficient treatments for management of stress urinary incontinence (SUI)~     following radical prostatectomy (RP), but no comparative study of these two techniques has~     been published. The investigators aims were to compare the efficacy of the two devices and~     provide data about their cost effectiveness.~      Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is~     more efficacious than Pro-ACT balloons at one year follow-up.~      Primary objective: The primary objective of this study is to compare the efficacy of the~     AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after~     RP at one year follow-up.~      Secondary objectives:~        -  Comprehensive comparative medical evaluation of the two devices in terms of efficacy~        -  Complete evaluation of the side effects of the two techniques~        -  Evaluation of the quality of life~        -  Evaluation of patient satisfaction~        -  Cost-effectiveness study of the device (total cost over one year of each of the two~          techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential~          cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be~          made for assessing the potential coverage by the French healthcare system) Population:~          Patients with history of RP without cancer recurrence, presenting pure SUI on~          urodynamics (without detrusor overactivity), of mild to moderate degree (24hour~          pad-test < 300g).~      Study design: This is a prospective, randomized, multicentric (9 tertiary reference~     centers), comparative trial of the two devices (with a superiority hypothesis). The total~     number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in~     4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of~     life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with~     PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end~     of the follow-up, in intent to treat.~      Medical evaluation:~      Main criterion:failure of the treatment, defined by reduction of less than 50% of~     incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical~     device for SUI.~      Secondary outcome criteria~        -  pad usage per day~        -  quantitative reduction of the 24hr-pad test~        -  complications (infection, erosion, hematoma, acute urinary retention)~        -  number of re-interventions or re-admissions during follow-up~        -  quality of life measured by the ICIQ-SF questionnaire~        -  patient satisfaction by the PGI-I questionnaire~      Economic evaluation:~        -  Study of the total cost over one year in each case~        -  Adjustment of cost of each device to quality of life (QALY evaluation)~        -  Cost effectiveness study~        -  Proposals will be made to state at which level the two devices should be covered by the~          healthcare system.~   "
118844|NCT01500590|"~     Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40%~     of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy.~     Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies~     already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in~     patients with varying degree of albuminuria, few studies focus on studying the decline in~     glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial~     number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From~     literature, diabetes mellitus will have faster decline in GFR but the investigators do not~     know whether such decline can be slowed down by the use of RAS blockers as compared with~     other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS~     blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.~   "
118845|NCT01500577|"~     The primary objective of the proposed trial is to assess. The efficacy and the safety of a~     daily administration of nimesulide or simvastatin to change the expression of a large set of~     tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in~     women at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The~     primary endpoint is the change in prevalence of atypical cells and cellular proliferation~     (Ki-67), after 12 months of treatment.~   "
118846|NCT01500343|"~     The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory~     response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in~     chronic heart failure patients.~   "
118847|NCT01500330|"~     The purpose of this randomized controlled study is to determine the effectiveness of cupping~     massage as home use for patients with chronic nonspecific neck pain compared to relaxation~     exercise.~   "
118848|NCT01500317|"~     Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the~     dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there~     is potential for off label use in chronic pain.~      Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is~     a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid~     receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in~     pain relief. While its action reflects aspects of tramadol and morphine, its ability to~     control pain is more on the order of hydrocodone and oxycodone.~      Its dual mode of action provides analgesia at similar levels of more potent narcotic~     analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect~     profile. Clinical studies showed that tapentadol effectively relieves moderate to severe~     pain in various pain care settings. In addition, it was reported to be associated with~     significantly fewer treatment discontinuations due to a significantly lower incidence of~     gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The~     combination of these reduced treatment discontinuation rates and tapentadol efficacy for the~     relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in~     pain therapy by increasing patient compliance with their treatment regimen.~   "
118849|NCT01500304|"~     The purpose of this this study is to determine if a structured educational training program~     is successful in teaching surgeons a new operative technique. It will then be determined if~     this new operative technique is safe.~   "
118850|NCT01500291|"~     It is inevitable that nearly both anesthesiologist and nurse anesthetist take a zero~     tolerance approach to avoidable safety problems in the provision of anesthesia.~      We would like to study the stress upon anesthesia personnel by using Suanprung Stress Test~     (SST) - a well-documented, psychological stress test, and Siriraj Anesthesia-related Stress~     Test (SAST) - a new developed open-ended opinion poll, to scrutinize the daily rounds stress~     and yield the solution to eradicate or alleviate those worries as well as improve both~     physical and mental health to handle the situation of difficulties.~   "
119436|NCT01492556|"~     The purpose of this study is to determine whether Etoposide Monotherapy is effective and~     safe in the treatment of recurrent or metastatic breast cancer in Chinese female patients.~   "
118851|NCT01500278|"~     This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy~     of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX)~     in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding~     adequately to MTX.~   "
118852|NCT01500265|"~     Nucleotide analogues are associated in the long term with a risk of proximal tubular~     nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed,~     with osteopenia or osteoporosis. This toxicity has been particularly documented for~     tenofovir (TDF) in HIV disease, but its prevalence varies widely in the literature and is~     mainly associated with comorbidities: on average this prevalence is 0.39% after 48 weeks~     with exceptional cases of Fanconi syndrome described. In HBV monoinfection after 60 months~     of treatment with TDF, an 11% decrease of creatinine clearance (CreatCl) is observed. A~     single study showed a significant increase in creatinine level with entecavir (ETV) therapy,~     a second-generation nucleoside, hitherto not described as nephrotoxic. Furthermore, if the~     direct renal toxic effect characteristic of HIV in the kidney is well known, the role of HBV~     is less clear. Thus, HBV treatment appears to have a renal protective effect. The monitoring~     tools recommended by the SPC, CreatCl and plasma phosphorus level are late markers of~     tubular damage. The threshold of phosphate tubular reabsorption (TmPi/GFR) and the~     fractional excretion of uric acid (FEUA) are unexpensive early screening tools. However, the~     long-term evolution of this subclinical tubular involvement in HBV monoinfection is not~     known.~   "
118853|NCT01500252|"~     Background:~      Despite the excellent results of total knee replacement, also known as total knee~     arthroplasty (TKA) there is persistent controversy over whether or not to replace the~     surface of the kneecap. Anterior knee pain, which occurs with variable and unpredictable~     frequency, continues to be a problem in a subset of TKA patients. Some clinicians replace~     the surface of all kneecaps during TKA to avoid repeat surgery, which occurs in~     approximately 10% of cases. However, others cite the complications attributed to replacing~     the surface of kneecap as reasons to avoid this procedure.~      This study prospectively randomized patients receiving TKA into two groups, those receiving~     replacement of the kneecap surface and those left without replacement of the kneecap surface~     to determine clinical outcomes and revisions over the first 5-10 postoperative years.~      Objectives:~      The primary objective of this work was to compare pain, stiffness and function between~     groups at five years postoperatively. Secondarily, we compared pain, stiffness and function~     at one and 10 years postoperatively. Finally, we examined the number of reoperations~     following TKR over 10 years in the 2 groups of subjects. The investigators hypothesized that~     there would be no difference between the two groups of subjects in the measured outcomes.~      Methods:~      Patients receiving TKA were prospectively enrolled before surgery and randomized~     intraoperatively to either receive a replacement of the kneecap surface or have no kneecap~     intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the~     post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and~     5 years postoperatively for pain, function, and stiffness using a disease-specific (Western~     Ontario and MacMaster Osteoarthritis Index [WOMAC]) and generic health status (Short Form 36~     [SF-36]) questionnaire. At the end of the five year follow-up, the study was extended to a~     10-year followup and the same outcomes were assessed. The revision rate was also compared~     between the two groups at the end of the 10-year follow-up.~   "
118854|NCT01500226|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered~     prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone.~     Subjects will record all events of emesis and the use of rescue medication for established~     nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of~     the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC~     administration through Day 6 in Cycle 1. Health-related quality of life will be measured by~     the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by~     clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs),~     and safety laboratory values. All subjects are expected to complete Cycle 1 and will have~     the option of participating in up to five additional cycles.~   "
118855|NCT01500213|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered~     1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone.~     Subjects will record all events of emesis and use of rescue medication for established~     nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of~     the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC~     administration through Day 6 of Cycle 1. Health-related quality of life will be measured by~     the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by~     clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs),~     and safety laboratory values.~      All subjects are expected to complete Cycle 1 and will have the option of participating in~     up to five additional cycles.~   "
118856|NCT01500200|"~     This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to~     adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant~     therapy.~   "
118857|NCT01500187|"~     Study will look at ability of fluoride varnish to remineralize white spot enamel lesions~     that can occur around the edge of fixed orthodontic brackets.~   "
118858|NCT01500174|"~     The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for~     healing pressure ulcers in people with spinal cord injury. UVC is a form of radiation~     similar to sunlight but it is normally absorbed in the earth's atmosphere. Participants will~     be assigned by chance to receive placebo-UVC or real UVC treatment, in addition to receiving~     wound care according to best practice guidelines. The hypothesis is that UVC-treated wounds~     will heal at a faster rate than wounds receiving placebo treatment.~      Given that pressure ulcers impact on an individual's quality of life, and generate high~     costs to the overall health care system, further work is needed to explore alternative means~     of pressure ulcer treatment.~   "
118859|NCT01500161|"~     The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for~     unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also~     to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.~   "
118860|NCT01500148|"~     The purpose of this proof-of-concept study is to assess the relative safety and feasibility~     of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.~   "
118861|NCT01500135|"~     Present trial is the third study that in combination with two completed studies (one being a~     trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted~     toward providing clinical safety and efficacy data to support extending the current label of~     TachoSil® to a general hemostasis indication across several surgical procedures and organ~     systems in the USA.~   "
120814|NCT01474577|"~     The physician would like to see if nuclear cardiac stress tests can predict cardiac health.~     For example, if a patient has an abnormal stress test, is he or she more likely to have~     cardiac problems in the future?~   "
118862|NCT01500122|"~     The primary objectives of the study are:~        -  To compare the pharmacokinetic profiles of RhuDex administered as two novel oral~          formulations~        -  To identify the lead formulation and optimise the pharmacokinetic profile by modifying~          the quantitative composition of that formulation~        -  Optional: To assess the intravenous pharmacokinetics of RhuDex following administration~          of an IV microtracer of [14C]RhuDex~   "
118863|NCT01500109|"~     The purpose of this investigator-initiated study is to determine whether acetaminophen is an~     effective pain reliever for primary cleft palate repair in children and possesses opioid~     sparing effects. Additionally, the investigators will determine if patients who receive~     acetaminophen have less opioid related side-effects. The study will have three study groups~     based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral~     acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine)~     alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the~     intraoperative period and 24 hours after surgery for all patients within the study and~     converted to morphine equivalents.~   "
118864|NCT01500096|"~     The purpose of this study is to determine whether American ginseng is effective in the~     treatment of HIV-associated fatigue.~   "
118865|NCT01500083|"~     The purpose of the current study is to evaluate additional safety data of bendamustine in up~     to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab~     regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of~     bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in~     several countries, which have been shown to be reasonably well tolerated. The study protocol~     includes safety monitoring (i.e., adverse events, concomitant medications, supportive care,~     clinical safety laboratory tests, and clinical disease status monitoring).~      It is an interventional, multicentre, prospective, open-label expanded access study, which~     in addition allows investigators in Canada, and their patients, access to bendamustine while~     it is pending Canadian marketing approval.~      Although the treatment options available for patients with iNHL or CLL do induce substantial~     responses, there is no curative treatment. One potential drug candidate for the treatment of~     CLL and iNHL is bendamustine.~      Bendamustine has been widely used in Germany for more than 30 years and is marketed in the~     United States for treatment of CLL and for treatment of iNHL that has progressed during or~     within 6 months of treatment with rituximab or a rituximab-containing regimen. In October~     2010, the European Medicines Agency formally approved bendamustine in a number of Member~     States of the European Union for the treatment of patients with iNHL, CLL, and multiple~     myeloma. The drug's safety profile in these patient populations has been extensively~     characterized and no unexpected safety concerns are anticipated.~   "
118866|NCT01500070|"~     This is a single-arm, prospective, multi-center monitored trial recruiting patients with~     critical limb ischemia and with one or more lesions in the arteries below the knee. The~     immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting~     Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System~     (Boston Scientific) will be evaluated.~      In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will~     be recruited. Primary endpoint is primary patency at 12 months, defined as absence of~     restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on~     angiography.~   "
118867|NCT01500057|"~     This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus~     BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic~     Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up~     visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.~   "
118868|NCT01500044|"~     The primary objective of this randomised clinical trial (RCT) is to compare, in terms of~     disability and pain, an intervention targeting the opening of intervertebral foramens to a~     conventional physiotherapy intervention, in patients presenting acute or subacute cervical~     radiculopathies. Based on biomechanical principles, the investigators hypothesis is that the~     intervention targeting the opening of intervertebral foramens will be significantly more~     effective in reducing pain and disability than the conventional physiotherapy intervention.~      This study is double-blind RCT that will allow the comparison of patients with a cervical~     radiculopathy randomly assigned to one of two groups: one group will receive a 4-week~     rehabilitation program targeting the opening of intervertebral foramen, and the second group~     will receive a 4-week conventional rehabilitation program. Thirty-six subjects will be~     recruited from participating medical and physiotherapy clinics in the Quebec City area~     (Canada) and will be evaluated at baseline, at the end of the program and four weeks~     following the end of the program. The primary outcome measure will be the validated Neck~     Disability Index (NDI) questionnaire and other secondary measures will include the QuickDASH~     questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients'~     perceived global rating of change.~   "
118869|NCT01500031|"~     Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic~     total occlusions in native femoropopliteal arteries.~   "
118870|NCT01500018|"~     This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to~     placebo, ketamine, and phentermine in healthy recreational polydrug users.~   "
118871|NCT01500005|"~     The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide.~      Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.~      Recently, increasing amount of evidence suggests that vitamin D may influence various~     nonskeletal medical conditions, including cardiovascular disease, hypertension, diabetes,~     cancer, autoimmune disorders and more. The purpose of this trial is to investigate the~     effect of vitamin D supplementation on 24 hours blood pressure monitoring, arterial~     stiffness, oxidative stress and inflammation in vitamin D deficient diabetic patients.~   "
118872|NCT01499992|"~     The aim of this study to define the optimal rehabilitation for clients with full thickness~     rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage~     in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion,~     shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic~     physical therapy in enhancing the post-operative outcomes.~   "
119437|NCT01492543|"~     The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur~     Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female~     patients with advanced metastatic breast cancer.~   "
118873|NCT01499979|"~     Rationale~      Currently, hepatic resection is often the only curative treatment for primary or secondary~     hepatic malignancies and is also frequently performed in patients with benign liver tumors~     to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays~     associated with low mortality and acceptable morbidity. As result of that, an increasing~     number of patients is currently under consideration for resection of more complex or large~     tumors, thus requiring extensive resection procedures. Application of vascular exclusion~     (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood~     loss, which is one of the most important factors affecting peri-operative outcomes. However,~     vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect,~     which adversely impacts postoperative liver function and regeneration. Additional cooling of~     the liver by means of hypothermic perfusion is expected to further reduce intraoperative~     blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this~     pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy~     under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is~     expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a~     better ability of the liver remnant to regenerate.~      Objective~      To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during~     right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion~     with retrograde outflow (R-IHP) of the FRL.~      Study design~      The study is designed as a prospective randomized pilot study in 18 patients (9~     interventions and 9 controls) to assess the effects of the proposed intervention.~     Additionally, 4 patients will be included separately for assessment of the intervention's~     feasibility prior to randomized inclusion.~      Study population~      Eligible patients for participation in this study are those planned to undergo right~     hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver~     tumor, and who do not suffer from any hepatic co-morbidity that might influence~     postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C~     infection).~      Intervention~      During right hemihepatectomy, the FRL of patients allocated to the intervention group will~     be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).~   "
118874|NCT01499966|"~     Until now very few studies have been done to compare the efficacy of tubigrips or plaster of~     paris in the treatment of lateral ankle sprains, the investigators aim to compare the~     tubigrip against plaster of paris in the treatment of lateral ankle sprains.~   "
118875|NCT01499953|"~     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus~     fondaparinux in the treatment of superficial vein thrombosis (SVT).~   "
118876|NCT01499940|"~     Many patients with cancer that are treated with a drug called oxaliplatin. This drug is used~     with other drugs to treat cancer. The drug can cause problems with the nerves in the hands~     and feet called peripheral neuropathy (a side effect of the drug). Peripheral neuropathy may~     make the hands and feet feel like they are tingling, have a burning feeling, and can cause~     pain. Almost all patients who receive oxaliplatin as part of their cancer treatment have~     peripheral neuropathy. Patients who do have this side effect usually have to take a lower~     dose of or stop taking the oxaliplatin even if the drug is helping their cancer.~      So far there is not a lot of information about how to make this side effect better or help~     it go away completely. There is some information that low levels of Vitamin D in the blood~     might be linked to problems or diseases of the nervous system like multiple sclerosis or~     Parkinson's Disease. It is even thought that Vitamin D may help protect the cells in the~     nervous system. Because of this information, researchers want to see if giving patients~     Vitamin D while they are receiving the drug oxaliplatin to see if it helps prevent the side~     effect peripheral neuropathy.~      Patients taking oxaliplatin who want to be in this study will take one Vitamin D capsule~     each day while they take oxaliplatin. Being in this study will not affect how the patient's~     cancer is treated. There are blood tests in the study to check Vitamin D levels and for a~     protein called nerve growth factor (NGF). The study team will carefully monitor the patients~     for any signs of oxaliplatin-related neurologic toxicity during the study.~   "
118877|NCT01499927|"~     Switching from intravenous application of antiinfective agents to oral therapy is often~     performed late including high costs and risk of complications. This study will investigate~     the impact of displayed reminders in the electronic patient chart after 60h of intravenous~     therapy with an antiinfective agent.~   "
118878|NCT01499914|"~     Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in~     the Ile de France during the 2009-2010 influenza season with the main objective to assess~     the effectiveness of antiviral vaccination (H1N1). All subjects will be included, without~     excluding factor. In particular populations at risk are additional infants 6 to 23 months,~     pregnant women and lung transplant will also be included. These people will be vaccinated~     with un-adjuvanted vaccine.~      If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza,~     oseltamivir is administered in accordance with official recommendations and based on the~     results of the pharmacokinetic study.~   "
118879|NCT01499901|"~     In France the indication of bilateral cochlear implant (CI) is limited to specific cases.~     The impact on perception and language of bilateral CI simultaneous versus sequential has to~     be established before discussing the enlargement of indications.~   "
118880|NCT01499888|"~     The investigators propose to determine the engraftment and transplant related morbidity and~     mortality after a non-myeloablative allogeneic hematopoietic stem cell transplant protocol~     using immune- suppressive agents and low-dose total body irradiation (TBI) without standard~     chemotherapy in patients with aggressive sickle cell disease who are not candidates for or~     experienced complications from hydroxyurea therapy.~      Fully HLA matched siblings will be used as donors for hematopoietic stem cells to reduce the~     risk of morbidity and mortality in this cohort of patients.~   "
118881|NCT01499875|"~     The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin~     V in non-infectious children to estimate the optimum dosage regime in children.~   "
118882|NCT01499862|"~     This pilot study examined the effect of task-oriented mobility training in three persons~     chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion~     Bionic Leg).~   "
118883|NCT01499849|"~     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled~     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered~     prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects~     will record all events of emesis and use of rescue medication for established nausea and/or~     vomiting, and will indicate the severity of nausea they experienced in each of the previous~     24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through~     Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire~     on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse~     events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory~     values.~      All subjects are expected to complete Cycle 1 and will have the option of participating in~     up to five additional cycles.~   "
120138|NCT01483417|"~     Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus~     conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS~     is not inferior to that of conventional approach.~   "
118884|NCT01499836|"~     Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain~     and side effects after breast surgery when used in addition to general anesthesia or~     sedation.The investigators would like to further discern the impact of GA or PVB on the~     postoperative QoR, pain and satisfaction.~   "
118885|NCT01499823|"~     The aim of the present study is to assess whether a new method of quantifying~     therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish~     pseudoprogression from true progression in patients with high grade glioma, who received~     CCRT.~   "
118886|NCT01499810|"~     Single-center, single group study of the efficacy and safety of transcatheter renal~     denervation for treatment of patients with essential hypertension uncontrolled despite~     combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic.~     Bilateral transcatheter renal denervation will be performed on the top of existed~     pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery~     thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months~     of follow-up.~   "
118887|NCT01499797|"~     The purpose of this study is to investigate the effect of the CareWell-programme on overall~     functioning of community-dwelling frail elderly persons. Furthermore, the total costs and~     the cost-effectiveness of the CareWell-programme, in comparison with regular medical care,~     will be studied.~   "
118888|NCT01499784|"~     Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence~     varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a~     serious medical problem that can lead to urinary tract infections, low back pain,~     respiratory disorders, pressure sores, and an increased risk of falls. It also leads to~     social problems, creating embarrassment and negative self-perception for those who suffer~     from it. Women with urinary incontinence find themselves isolated and relatively inactive. A~     wide range of treatments has been used in the management of women's UI, including~     conservative interventions, pharmaceutical intervention, and surgery. A Cochrane Review from~     2008 stated that pelvic floor muscle training (PFMT) is better than no treatment for UI and~     supports the recommendation that PFMT should be the first treatment line in conservative~     management programs for women with UI. Recently, there have been a few articles published~     that looked at the effectiveness of treating UI in a group-like setting with both behavioral~     modifications and pelvic floor exercises. One study was able to prove that group training of~     behavioral modification helped to reduce UI severity, increase pelvic floor strength, and~     reduce voiding frequency when compared to a control group.~      All of the studies cited were performed in community-dwelling persons with out-patient~     services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation~     Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients~     admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697~     Medicare beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies~     were able to illustrate that UI affects all diagnoses. UI was shown to make a significant~     contribution to patient outcomes independent of functional status at admission. It is also a~     large determinant of discharge destination. In the United Kingdom in 2004, 62% of~     incontinent stroke patients were discharged to a sub acute home with only 5% placement for~     continent stroke survivors. Another study determined that urinary incontinence after having~     a stroke predicted a higher likelihood of an adverse outcome when controlled for age, type~     of stroke, and length of hospital stay. May, et. al., was able to state while in an acute~     rehab setting that patients with spinal cord injuries ranked bowel and bladder care, along~     with skin care, as most important in an education class with 12 different topics. This shows~     that patients find bladder function a large priority in their care, even in an in-patient~     setting. In the poster presentation mentioned above, many patients with UI in an acute care~     rehab setting do not improve Functional Independence Measure (FIM) status from admission to~     discharge. Currently there is no research available for the treatment of UI in an acute care~     rehab hospital, though it has been shown to be an issue with many of those admitted. So the~     question arises, Would addressing urinary incontinence with physical therapy interventions~     and behavioral modifications improve incontinence in this population during the acute rehab~     stage?~   "
118889|NCT01499771|"~     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets~     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM~     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of~     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)~     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x~     80 mg tablet) in healthy adult subjects when administered under fed conditions.~   "
118890|NCT01499758|"~     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets~     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM~     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of~     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)~     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x~     80 mg tablet) in healthy adult subjects when administered under fasting conditions.~   "
118891|NCT01499745|"~     -  Idiopathic pulmonary fibrosis (IPF) is a chronic progressive, fibrosing parenchymal~          lung disease with unknown etiology. The prevalence of IPF is estimated between 2-29~          cases per 100,000 in general population with median survival rates of 2-5 years from~          time of diagnosed.~        -  Dyspnea and chronic dry cough are the prominent symptoms in those patients which cause~          to impaired functional capacity and quality of life (QOL).~        -  Drug therapy usually is ineffective approach, what makes a call for an effective~          treatment.~        -  Pulmonary Rehabilitation (PR) had been founded as safe and effective treatment in~          increasing functional capacity, decrease symptoms and improve QOL mainly among Chronic~          Obstructive Pulmonary Disease (COPD). However, recently growing evidence also supports~          the efficiency of PR in IPF patients.~        -  The Aim of the suggested study is to examine the effect of exercise training (ET) at~          ambulatory pulmonary rehabilitation among IPF patients.~        -  The investigators hypothesize that ET at PR program will increase functional capacity,~          will decrease level of dyspnea and improve QOL in IPF patients.~        -  Patients and Methods:~        -  40 IPF patients males and females (aged 30-90 years old) will be recruiting to this~          study. After clinical assessment they will be randomly allocated to PR group n=20 or to~          Control group n=20.~        -  All patients will undergo a clinical assessment including medical history, risk factors~          for IPF and physical examination. On the first meeting at baseline and within one week~          post intervention (PR) the following measurements will be made: dyspnea score, QOL and~          physical activity level questionnaires. In addition, anthropometric measurements,~          echocardiography, blood samples, pulmonary function tests, cardiopulmonary exercise~          test, battery of functional test and 6 minute walk test (6MWT).~        -  The PR group will participate in 12 weeks of supervised group's ET program. The~          training program will be consisted two 6 week blocks of 60 min exercise bout twice a~          week. In the first block the patients will perform aerobic interval training with~          treadmill walking, cycling, and step climbing. In the second block, subjects will~          perform longer periods of continuous aerobic exercise, with resistance training by step~          climbing, unsupported arm/leg exercises with and without dumbbells (0.5-1 kg), and~          supporting body weight over a chair. Pulmonary function test and 6MWT will be also~          performed after completing first 6 week block. The control group will be assessed at~          baseline and after 12 weeks without participating in PR program.~   "
118892|NCT01499732|"~     Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.~   "
118893|NCT01499719|"~     The purpose of this clinical trial is to evaluate the effectiveness of a new surgical~     checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and~     to measure the frequency of compliance by surgical personnel at OHSU with specific daily~     safety protocols before and after introduction of the checklist. The investigators~     hypothesized that the use of an ESS specific surgical checklist will improve the frequency~     of compliance by surgical personnel at OHSU to internal safety concerns and protocols.~   "
118894|NCT01499706|"~     The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to~     rise due largely to~        -  better clinical care and the improved efficacy of highly active antiretroviral therapy~          that has extended the lives of many HIV-positive persons~        -  an increase in the number of new HIV infections in older persons. This study tested the~          efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction~          interventions for HIV-positive adults 45-plus years of age who engage in risky sexual~          behaviors.~   "
118895|NCT01499693|"~     The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day~     (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium~     pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and~     standard dose of proton pump inhibitors.~   "
118896|NCT01499680|"~     This is a prospective, non-randomized multi-center study to evaluate intraoperative~     neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF)~     surgery at any number of levels inclusive of L4-5.~   "
118897|NCT01499667|"~     This study evaluated disease control during different lengths of treatment transition from~     natalizumab to fingolimod.~   "
118918|NCT01499394|"~     The Biorepository for Caris Life Sciences is designed for the purpose of making quality~     biospecimens and associated clinical data available for research studies related to~     advancing precision medicine and improving care for patients.~      The Caris Biorepository is a repository of prospectively collected biological specimens and~     associated clinical and demographic data gathered from multiple sources to be stored, used~     and shared for research. Caris Life Sciences will maintain the data and specimens and will~     control access to and use of the information and specimens by multiple individuals for~     multiple purposes which may evolve over time.~   "
118898|NCT01499654|"~     This study is recruiting patients already scheduled for a single photon emission computed~     tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging~     technique that uses a radioactive substance, or radiotracer, and special equipment to create~     three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make~     the structures of the heart visible and is routinely used to view blood flow in the heart,~     scan for damaged heart tissue, or assess heart function.~      For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the~     test, followed by taking resting images of the heart. For this study, researchers would like~     to administer half of the radiotracer, obtain resting images, administer the remainder of~     the radiotracer and obtain a second set of resting images. Participants will receive the~     same amount of radioactive material that would normally be given for this test; however, it~     will be administered in two half-doses. Participation in this study will add about 30~     minutes to the time it takes to complete the routine test. The investigators expect to~     enroll about 160 subjects in this study at Northwestern.~   "
118899|NCT01499641|"~     Focus of this study is evaluation of the outcome, neurologic impairment and safety of~     epidural steroide following lumbar discectomy for herniated disc disease.~   "
118900|NCT01499628|"~     Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in~     the UK, Europe and N America. Low vision patients with AMD have great difficulty reading,~     which leads to a loss of independence and reduced quality of life. Magnifiers alone do not~     compensate for loss of central vision in AMD. It has been proposed that special low vision~     training can improve reading ability in patients with AMD. Training programmes are widely~     available in the US and Scandinavia, but not in the UK, partly because there is a lack of~     evidence from Randomised Control Trials (RCT) showing that they are effective. The~     investigators are conducting a clinical trial comparing the conventional hospital−based low~     vision service to enhanced rehabilitation programmes that include Eccentric Viewing~     training. Eccentric viewing training involves teaching patients who have lost their central~     vision to use a new area of retina for visual tasks. Patients are either taught to improve~     the use of the part of the retina they naturally start using after their central vision is~     lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to~     use a different retinal area that is thought to be better suited for everyday visual tasks,~     the so-called trained retinal locus (TRL). The investigators plan to compare the two types~     of eccentric viewing training to conventional hospital-based low vision care.~   "
118901|NCT01499615|"~     Traditionally cardiac output has been estimated with thermodilution. Recently a new~     non-invasive device has been approved by the FDA for use in children of all ages including~     neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous~     physiologic data for all enrolled children by transferring the data from the investigators~     computerized anesthesia records to Excel spreadsheets and to correlate adverse events across~     monitoring devices.~      Secondary outcomes: To determine if the device provides meaningful data in terms of an early~     warning of decreased cardiac output in specific subgroups of children undergoing surgery and~     anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those~     undergoing procedures with expected blood loss, those undergoing laparoscopic procedures~     where gas insufflation may impede venous return to the heart.~   "
118902|NCT01499602|"~     The purpose of this study is to compare the efficacy of the Levonorgestrel releasing~     Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical~     endometrial hyperplasia in perimenopausal women.~   "
118903|NCT01499589|"~     Study of time usage of anesthesia team inside the main operating room compares between 2~     groups of~        -  Performing regional anesthesia inside the operating room~        -  Performing regional anesthesia in the block room~      Study purpose: How much will the investigators save time in the main operating room if we~     perform the regional anesthesia in the block room?~   "
118904|NCT01499576|"~     The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high~     risk group of gastric cancer. Many methods was developed to survey it, including multiple~     gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine~     screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used~     in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The~     investigators have confirmed such whitish discoloration is induced in gastric IM, with~     accuracy > 80% in a pilot study of the investigators. This prospective study will tell the~     accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.~   "
118905|NCT01499563|"~     The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms~     associated with schizophrenia in patients who are having an acute worsening of their~     psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007,~     placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on~     psychosis. The safety of ITI-007 will also be assessed.~   "
118906|NCT01499550|"~     On the basis of different studies the long term oxygen treatment is deemed to be routine~     treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at~     appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in~     hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation.~     Several prospective randomized studies have shown a reduction of acute mortality as result.~     But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom~     oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary~     overinflation or the appearance of depressions or rather anxiety disorders are possible~     causes. On the other hand patients may not notice any subjective improvement of symptoms and~     won't accept the burden of a tight fitting mask during the night. The aim of the present~     study is to determine the effect on gas exchange of a nocturnal transnasal application of an~     oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is~     compared to a nocturnal transnasal application of oxygen alone in randomized order for at~     least 6 hours each night.~      Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night~     Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements,~     breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At~     begin and end of each measurement night a capillary blood gas analysis is made.~   "
118907|NCT01499537|"~     At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard~     method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail~     or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD)~     is the most commonly used alternative, surgery having higher morbidity and mortality rates,~     unacceptable especially in palliative situation. Recent developments in interventional~     endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary~     structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were~     described the possibility to realize EUS-guided biliary drainage, through the duodenal or~     the gastric wall. Advantages of the EUS-guided approach are to be realizable even the~     papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to~     allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique~     is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to~     have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of~     the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively~     from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques.~     Aims of this study are to compare the morbidity rate, feasibility and efficacy of these~     techniques.~   "
118908|NCT01499524|"~     ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased~     risk of diseases of the biliary system in later life. There have been small studies (Dann et~     al. 2006; Wójcicka-Jagodzińska et al. 1989) suggesting that it causes dyslipidaemia (raised~     lipids) and impaired glucose tolerance in pregnancy. However the underlying mechanisms of~     these abnormalities is not known. Similarly the influence of cholestasis on fetal metabolism~     is not known, and nor is the role of the placenta. It is also not known whether women with~     ICP have a predisposition to abnormal lipid and glucose homeostasis when they are not~     pregnant.~      GDM is characterized by raised plasma glucose levels in pregnant women (in the absence of~     pre-pregnancy diabetes mellitus). This condition is associated with large-for-gestational~     age babies and obstructed labour. Women with GDM have increased risk of subsequent type 2~     diabetes mellitus, and if they have this condition in a subsequent pregnancy there is an~     increased risk of stillbirth. This work is important to understand the causes of the~     metabolic abnormalities associated with ICP and GDM. If we demonstrate abnormal lipid and~     glucose profiles, these may be of relevance to the fetal complications of both disorders. It~     will also be of relevance to the future health of affected women and their children.~   "
118909|NCT01499511|"~     ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the~     Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and~     2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a~     cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a~     blood-pressure lowering strategy based on amlodipine when compared to a strategy based on~     atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received~     Atorvastatin and those who received amlodipine based treatment will continue to show a~     cardiovascular benefit relative to those who did not, even though all the subjects have had~     access to optimal treatment in the interim.~   "
118910|NCT01499498|"~     This is a healthy volunteer study looking at the interactions between two drugs: boceprevir~     and sildenafil.~      New drugs are being developed to treat people with the chronic viral infection hepatitis C.~     Very little is know how these new treatments interact with other medications such as the~     drugs used to treat erectile dysfunction.~      The purpose of this study is to look at levels of both a new hepatitis C drug called~     boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they~     affect the blood levels of each other when given separately and together.~   "
118911|NCT01499485|"~     The purpose of this study is to analyze whether the treatment of metabolic alkalosis with~     acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or~     with obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation~     (MV).~   "
118912|NCT01499472|"~     The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added~     to standard of care wound therapy significantly improves time to complete wound healing in~     diabetic foot wounds.~   "
118913|NCT01499459|"~     This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC)~     transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem~     cell will be derived from patients' bone marrows and will be infused via peripheral vein.~     Liver biopsies will be performed in every patient in the beginning and at 6th month.~   "
118914|NCT01499446|"~     The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once~     daily either in the morning or the evening and GW685698X 250mcg administered once daily in~     the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.~   "
118915|NCT01499433|"~     The investigators propose to study the efficacy and safety of three-week antifungal therapy~     with caspofungin in hospitalized patients with proven or probable IPA underlying chronic~     obstructive pulmonary disease.~   "
118916|NCT01499420|"~     Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS)~     may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent~     cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single~     ascending dose study in patients with stable atherothrombotic disease in whom the safety and~     pharmacokinetic profile of CSL112 will be assessed.~   "
118917|NCT01499407|"~     Subjects with ST-elevation myocardial infarction will be randomized, to one of the~     following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab~     infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C),~     or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to~     demonstrate that abciximab infusion with the ClearWay catheter with or without manual~     thrombus aspiration (groups C or T+C) will result in a significant reduction of intra-stent~     thrombus formations when compared to intravenous or intracoronary abciximab with or without~     thrombectomy (groups A or T+A). The primary endpoint will be the number of cross sections~     with thrombus area >10% immediately after stent implantation as assessed with OCT.~     Additional angiographic, ECG, and clinical endpoints will be collected and adjudicated. This~     trial is currently being registered at ClinicalTrials.gov.~   "
118919|NCT01499381|"~     The objective of this multi-center prospective observational clinical study is to evaluate~     the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of~     prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of~     the Carisome Prostate assay will be compared with pathology results of prostate biopsy~     procedures. Secondarily, the performance of the Carisome Prostate test will be compared to~     the current standard of care for the detection of prostate cancer.~   "
118920|NCT01499368|"~     To evaluate the healing rate and safety of Lafutidine in erosive esophagitis~   "
118921|NCT01499355|"~     The primary objective of the study is to assess the efficacy of BIIB023 as an add-on~     treatment to background therapy compared with placebo in combination with background therapy~     in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary~     objectives of this study are to assess the safety and tolerability of BIIB023 compared with~     placebo in this study population.~   "
118922|NCT01499342|"~     This is a Belgian prospective multicentre registry to evaluate safety and performance of the~     Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic~     lesions. Target number is 500 patients in approximately 11 centres. Patients will be~     followed for a period of 2 years.~   "
118923|NCT01499329|"~     The purpose of this study is to evaluate safety and performance of the balloon-expandable~     Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC)~     A, B, C and D iliac lesions.~   "
118924|NCT01499316|"~     Coronary artery disease (CAD) is a condition which refers to the narrowing of the small~     blood vessels that supplies blood and oxygen to the heart. It is a common cause of~     chest-pain related symptoms and as a result of a 'heart attack'. In most cases, to assess~     the severity of the disease is to use coronary angiography, which is a medical imaging~     technique that uses contrast (a dye) and x-ray to show the blood-flow supply of the coronary~     arteries.~      The optimal treatment for patients with symptomatic coronary disease is aggressive medical~     therapy. Current guidelines recommend patients with symptomatic CAD and severe disease on~     angiography undergo revascularisation therapy, which aims to restore blood flow to blocked~     arteries. This can be done by either percutaneous coronary intervention (feeding a small~     balloon or other device on a thin tube through blood vessels to the point of blockage and~     then inflate the balloon to open the artery), or coronary artery bypass grafting (open-heart~     surgery)2.~      For many symptomatic patients who have only moderate disease on angiography, further~     functional testing is required to assess the extent of the blockage. This can be achieved by~     placing a pressure wire to the artery of interest, to determine the likelihood that the~     blockage impedes oxygen delivery to the heart muscle, known as the Fractional Flow Reserve~     (FFR)3. FFR is commonly performed at the Alfred hospital in the assessment of such patients.~     During an FFR procedure, further information regarding the health of the small arteries of~     the heart can be obtained with the calculation of the index of micro-vascular resistance~     (IMR),~      Giving oxygen to patients with CAD is a common clinical practice, especially to all patients~     in the catheterisation laboratory whose had a 'heart attack' and often administered~     concurrently with light sedation during elective procedures.~      Recently, however, the safety of routine supplemental oxygen in patients with CAD has been~     questioned5. A research study analysed the outcomes of three small randomised studies on~     oxygen in patients who experienced a 'heart attack', while suggestive of harm, the findings~     of the study remain inconclusive.~      There may also be deleterious effects of supplemental oxygen, on more stable patients with~     CAD, who are not experiencing a 'heart attack'. Supplemental oxygen administered in the~     catheterisation laboratory to patients with stable CAD, has been shown to significantly~     reduce coronary artery blood flow and increase its resistance6-8. It has also been shown to~     reduce cardiac output and effect the relaxation phase of the heart cycle. Based on this data~     it is hypothesised that supplemental oxygen may affect FFR in patients with moderate CAD.~     The investigators therefore propose to undertake a study of the effects of supplemental~     oxygen on FFR in patients with moderate CAD.~      The patients enrolled into the study will be scheduled for an elective normal contrast~     diagnostic or interventional procedure as part of their clinically-indicated care. Once a~     moderate blockage of the artery has been identified, FFR and IMR will be measured. During~     the first phase of the FFR study, the patient will breathe room air and have a blood test to~     measure their oxygen level (blood gas). There is a 3 minute washout period, followed by the~     second phase, whereby the patient will be given 100% oxygen for 10 minutes and have another~     blood gas measured.~      The study will be conducted at Alfred Hospital with a total enrollment of 18 subjects. The~     estimated time to complete enrollment is 6-10 months.~      Data collected on each patient will include demographics, medical history, vital signs~     (heart rate, blood pressure, height, and weight), usage of cardiovascular medications,~     pathology results and procedural records. Any adverse events or serious adverse events~     related to the study procedure will also be recorded.~   "
118925|NCT01499303|"~     This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients~     with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse~     Large B-Cell Lymphoma (abbreviated as DLBCL)~   "
118926|NCT01499290|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus~     Metronidazole compared to Meropenem for treating hospitalized patients with complicated~     intra-abdominal infections.~   "
118927|NCT01499277|"~     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus~     Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft~     tissue infections.~   "
118928|NCT01499264|"~     Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best~     practice clinical care in subjects with burn injuries with particular regard to: 1) Wound~     healing (complete reepithelialization), 2) the patient's pain. In the context of the study~     will be collected secondary outcomes related to type of lesion and its clinical evolution~     through the analysis of the items in the scale of the PSST.~   "
118929|NCT01499251|"~     This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of~     macitentan in combination with dose-dense temozolomide in adult patients with recurrent~     glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation~     Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan~     in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and~     tolerability data of two doses of macitentan and dose-dense temozolomide selected from the~     Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the~     effects of macitentan on biomarkers in brain tumor tissue.~      The study is planned to have a minimum duration of 12 months. The study will end when all~     patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the~     study have completed a visit at month 12 and 30 days of safety follow-up.~   "
118930|NCT01499238|"~     The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients~     with wet lung.~   "
118931|NCT01499225|"~     This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients~     with chronic periodontitis, in order to investigate the recommended therapeutic dose.~   "
118932|NCT01499212|"~     The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio~     1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the~     lateral decubitus position.~   "
118933|NCT01499199|"~     ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be~     conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.~     Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once~     daily in combination with the fixed dose dual nucleoside reverse transcripatase~     inhibitor(NRTI) abacavir/lamivudine (ABC/3TC) for 96 weeks. One pair of pharmacokinetic (PK)~     samples in plasma and cerebral spinal fluid (CSF) (matching time) for determination of DTG~     concentration will be collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be~     collected at Baseline and various time points throughout the study and samples for HIV-1 RNA~     levels in the CSF will be collected at Baseline, Week 2 and Week 16. Safety, additional~     measures of antiviral activity and development of viral resistance will also be evlauated.~     The primary analysis will take place after the last subject completes 16 weeks on therapy;~     additional analyses will be conducted after the last subject completes Weeks 2 and 96 (end~     of study).~   "
118934|NCT01499186|"~     This randomized controlled intervention study in institutionalized elderly investigates the~     effect of 6 months of local vibration therapy applied on the thigh and hip on muscle~     strength, muscle mass, bone density, and functionality.~   "
118935|NCT01499173|"~     Getting to the hospital quickly is the key to treating stroke. African Americans suffer more~     strokes with worse outcomes and receive stroke treatments less often than European~     Americans. This project will work to reduce these health disparities by creating and testing~     the feasibility of a peer-led faith-based behavioral intervention in an African American~     community with a goal to increase calls to 911 so stroke patients can be treated quickly.~   "
118949|NCT01498978|"~     This phase II trial studies how well ipilimumab works when given together with androgen~     suppression therapy in treating patients with hormone-resistant prostate cancer that has~     spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block~     tumor growth in different ways. Some block the ability of tumors to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Androgen can~     cause the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal~     glands from making androgen. Giving ipilimumab together with androgen suppression therapy~     may kill more tumor cells.~   "
118936|NCT01499160|"~     About a third of patients with breast cancer are usually treated by hormone pills called~     tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone~     production. Female hormone or estrogen is an important hormone for the growth of breast~     cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and~     has been used to treat breast cancer since 1997. However, hormone pills usually work for~     about 6-10 months in most patients. Later on, breast cancer will start to grow again. This~     condition when hormone pills or endocrine therapy no longer work is called endocrine~     resistant breast cancer. The scientists here at University of Maryland have discovered how~     these cancer cells can become resistant to hormone pills. In our laboratory tests, the~     investigators found that lapatinib and everolimus can reverse this resistance and make~     letrozole work again. However, it is not known if the drugs can reverse the resistance in~     humans.~      The purpose of this study is to find out whether the combination of letrozole, lapatinib,~     and everolimus is effective in women with breast cancer when hormone pills no longer work.~      Lapatinib is an anti-cancer drug that is already approved by the Food and Drug~     Administration (FDA). It is the standard of care for the treatment of a particular type of~     breast cancer called human epithelial growth factor receptor 2 (HER2)-positive breast~     cancer. HER2 is a protein involved in the growth of some cancer cells. This study will also~     include patients with HER2-negative breast cancer. This means that the cancer cells in these~     patients do not depend on the HER2 protein. The use of lapatinib in these patients is~     considered experimental.~      Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer.~     Initial studies in mice and later studies in women with breast cancer have shown that~     everolimus may also slow the growth of breast cancer. The use of everolimus is experimental~     in this study.~   "
118937|NCT01499147|"~     New conditioning regimens are still needed to maximize efficacy and limit treatment-related~     deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past~     several years, the investigators have evaluated several new conditioning regimens that~     incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has~     synergistic activity with alkylating agents. Recent data have suggested that fludarabine may~     be used in combination with standard doses of oral or IV busulfan, thus reducing the~     toxicity previously observed with cyclophosphamide/ busulfan regimens.~   "
118938|NCT01499134|"~     This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an~     active control, metoprolol succinate, in patients with established lower-extremity~     peripheral artery disease, hypertension, and at least moderate risk for coronary artery~     disease.~   "
118939|NCT01499121|"~     This prospective single arm study will evaluate the efficacy and safety of sunitinib given~     on an individualized dosing schedule as first-line therapy in subjects with metastatic clear~     cell renal cell cancer. The treatment schedule intent is to maximize dose intensity of~     sunitinib and minimize time off therapy based on individual tolerability using protocol~     directed dose modification criteria. A total of 110 subjects will be enrolled. All subjects~     will continue to receive study treatment until disease progression or withdrawal of consent.~     The primary outcome for this study is progression-free survival (PFS), defined as the~     duration from the date a patient first receives Sunitinib until the date of death or~     confirmed progression according to the RECIST criteria.~   "
118940|NCT01499108|"~     Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of~     liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential.~     The time course and the mechanism behind this effect are unknown.~      Objectives: To evaluate the time course of the antihypertensive effect of liraglutide~     treatment in patients with type 2 diabetes~      Design: Open-label study with intervention and subsequent washout period~      Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2~     diabetes.~      Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and~     will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once~     daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide~     treatment.~      Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV~   "
118941|NCT01499095|"~     Primary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6)~          in adult participants with type 2 diabetes mellitus~      Secondary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          occurrence of nocturnal hypoglycemia~   "
118942|NCT01499082|"~     Primary Objective:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants~          with type 2 diabetes mellitus~      Secondary Objectives:~        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of~          occurrence of nocturnal Hypoglycemia~   "
118943|NCT01499069|"~     Nerve growth factor (NGF), prostaglandin E2 (PGE2)and adenosine triphosphate (ATP) levels in~     urine were reported to increase in patients with overactive bladder (OAB). Also,~     administration of the anti-muscarinic agent was reported to decrease urinary NGF and ATP.~      The investigators aimed to explore the value of the urinary NGF, PGE2 and ATP as biomarker~     for predicting the treatment responsiveness and symptom relapse in OAB patients. So, the~     patients can be categorized into responder or non- responder and relapse or non-relapse~     groups. Ultimately, they can receive individualized treatments.~   "
118944|NCT01499056|"~     Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant~     problems. First-line of management for patient with osteoarthritis consists of weight~     reduction, education, and analgesic medication. If necessary, invasive treatment like total~     hip replacement are performed for the patient. The objective of this study was to assess the~     safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip~     osteoarthritis~   "
118945|NCT01499043|"~     The main objective of this study is to evaluate the effects on the body that PLX3397 on male~     subjects with CRPC.~      Secondary objectives include evaluating the safety and tolerability of PLX3397 and the~     antitumor effects that PLX3397 has on the the subjects.~   "
118946|NCT01499017|"~     The primary purpose of this study is to evaluate the safety and tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy~     volunteers.~   "
118947|NCT01499004|"~     This study will explore the drug behavior and safety following a single dose of three~     different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy~     volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in~     an immediate-release formulation.~   "
118948|NCT01498991|"~     The purpose of this study is to determine if individuals with incomplete spinal cord injury~     (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move~     the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.~      The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete~     SCI will result in improved strength, sensation in the legs, and improved functional gait in~     the treated limbs.~   "
118950|NCT01498965|"~     The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional~     Sciences, University College Cork, and the Department of Dermatology, Trinity College,~     Dublin have a unique and urgent opportunity to form a birth cohort of over 2000 children~     whose growth and maternal health status will have been closely monitored from early~     pregnancy. Longitudinal monitoring of these infants will allow direct investigation of~     several research areas in a way which has not previously been possible in Ireland, or~     abroad. The investigators propose to focus on three main research themes: the effects of~     intrauterine growth restriction, the incidence and prevalence of food allergy and eczema in~     early childhood and the incidence and effects of maternal and infant vitamin D status on the~     growth and health of Irish children. Although the investigators initial proposal will focus~     on these important areas, the formation of this birth cohort will offer many opportunities~     for further research as the cohort grows older. It will form a unique bio-bank of~     information from Irish children collected longitudinally from soon after their conception.~     The mothers of these infants are currently being recruited, which leaves us with a narrow~     window of opportunity to put in place a pathway of investigation for these children. To~     ignore this opportunity would be to lose access to a wealth of information regarding child~     health and disease. The potential for this cohort to provide definitive answers to current,~     and future, theories of disease causation is enormous.~   "
118951|NCT01498952|"~     A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard~     of care in adult subjects with unresectable or metastatic HCC.~   "
118952|NCT01498939|"~     This trial is conducted in Asia. The aim of this trial is to investigate the~     pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.~   "
118953|NCT01498926|"~     This trial is conducted in Europe. The aim of this trial is to compare two formulations of~     insulin detemir containing an isotonic agent in healthy volunteers.~   "
118954|NCT01498913|"~     This study is conducted in Asia. The aim of this study is to review the safety and efficacy~     of Novonorm® (repaglinide) in post-marketing use.~   "
118955|NCT01498900|"~     This study is conducted in Africa and Asia. The aim of this study is to evaluate the~     efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes~     management in routine clinical practice.~   "
118956|NCT01498887|"~     This study will assess the efficacy of fingolimod in patients with short duration~     relapsing-remitting multiple sclerosis who have not been previously treated with~     disease-modifying therapies (DMTs), versus patients with the same disease duration who have~     previously received first-line Disease Modifying Therapies.~   "
118957|NCT01498874|"~     The purpose of this study is to determine whether gevokizumab is effective in the treatment~     of moderate to severe acne vulgaris.~   "
118958|NCT01498861|"~     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of HIV infection. DTG will likely be used in women on~     oral contraceptives (OC) for birth control. Based on accumulated non-clinical and clinical~     drug metabolism and pharmacokinetic data, there is a low likelihood of drug interaction~     between DTG and most widely used OC drugs. The primary objective of this study is to~     evaluate the effect of DTG administration on the pharmacokinetics and pharmacodynamics of a~     commonly used oral contraceptive product, Ortho-Cyclen (combination of norgestimate and~     ethinyl estradiol), in healthy female subjects. Each subject will participate in a Run-in~     period (if needed), followed by two treatment periods. Approximately 16 subjects will be~     randomized in a cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with~     Placebo for 10 days and switch to the alternate treatment for another 10 days. Subjects will~     return to the study center for final follow up evaluations 7 - 14 days after the final dose~     of study medication.~   "
118959|NCT01498848|"~     We conducted a randomized trial to determine the effect of providing families from Bogota,~     Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil,~     on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the~     effect of the oils on whole blood fatty acid composition in children, 2) assess the~     correlation between whole blood and saliva to evaluate if fatty acids measured in saliva~     would be adequate biomarkers of intake. The study was conducted in the context of an ongoing~     cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an~     intervention trial of 4 week duration. Participant families were randomly assigned to either~     sunflower oil or soybean oil. Families were visited two times during the 4 week period. We~     collected dietary information from the person in the household in charge of food~     preparation, and from the child. At the end of the intervention we collected information on~     whether or not they liked the oil and whether they would be willing to use it, exclusively,~     for two years, to assess acceptability for a longer intervention. We also collected two~     finger prick blood samples and two saliva/cheek cells samples from the child, at the~     beginning and at the end of the study, to evaluate compliance and to assess the impact of~     the intervention.~   "
118960|NCT01498835|"~     To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative~     treatment of locally advanced or recurrent soft tissue sarcoma.~   "
118961|NCT01498822|"~     To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment~     Failure Rate in subjects with newly diagnosed partial onset seizures with or without~     secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks~     from the first dose~   "
118962|NCT01498809|"~     This project aims to evaluate the physiological effects of Midodrine administration during~     orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown~     to improve orthostatic symptoms in those with spinal cord injury but the physiological~     mechanisms influenced have not been identified. The investiagtors will examine key~     physiological components influencing orthostatic tolerance. The investiagtors will do this,~     by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain~     brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one~     before Midodrine administration, and one after administration of a 10mg dose of Midodrine.~   "
118963|NCT01498796|"~     Our group wishes to test the novel hypothesis that intraoperative use of ketorolac in~     pediatric patients undergoing tonsillectomy reduces post-operative nausea and vomiting,~     postoperative pain scores, subsequent narcotic use, and length of hospital stay without~     adversely affecting post-operative bleed risk, when compared to placebo, in a double-blind,~     randomized controlled trial.~   "
118964|NCT01498783|"~     This is a phase I study to investigate the safety and pharmacokinetics of weekly~     5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with~     recurrent or refractory ependymoma. The results from this study will inform a subsequent~     phase II St. Jude investigator-initiated trial.~   "
118965|NCT01498770|"~     This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK)~     during the post-approval period under conditions of usual practice. The use of asenapine in~     Bipolar Disorder and other indications will be described. To provide epidemiological and~     clinical perspective, use of aripiprazole and other comparator drugs will be described.~   "
118966|NCT01498757|"~     To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based~     chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers~     to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to~     5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating~     tumor cells and circulating endothelial cell precursors and treatment response to~     Taxane/5-FU/platinum based chemotherapy.~   "
118967|NCT01498744|"~     The purpose of this study is to better understand why children develop methicillin-resistant~     Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether~     antibiotics are helpful after the infection is drained in the operating room.~   "
118968|NCT01498731|"~     Acute chest pain is commonly known to be the classic symptom of acute myocardial infarction.~     Of the many patients which visit the Emergency Department because of chest pain, less than~     half do actually suffer from an acute myocardial infarction or acute myocardial ischemia. In~     some patients the acute myocardial infarction can be diagnosed at admission, either because~     of typical changes in their ECG (STEMI, ST-elevation myocardial infarction)or because of~     increased levels of the laboratory value Troponin in their blood (NSTEMI, Non-ST-elevation~     myocardial infarction). Troponin is currently the most important marker to diagnose acute~     myocardial infarction. Unfortunately a lot of patients with suspected acute coronary~     syndrome do not show any ECG or Troponin changes. These patients pose a major problem in~     emergency medicine as they need to precautionally be admitted to a chest pain unit and to be~     started on medical treatment until a second Troponin test after 6-9 hours is available.~      In this study, we investigate the biomarker Copeptin. Copeptin has shown excellent results~     in diagnostic clinical trials assessing its use in various acute diseases. There are three~     important trials showing an excellent negative predictive value of Copeptin in combination~     with Troponin in patients with suspected acute coronary syndrome (Reichlin et al., JACC,~     2009; Keller et al. JACC, 2010, Giannitsis et al. Clin Chem 2011).~      This trial compares two processes of managing patients with suspected acute coronary~     syndrome (ACS), the standard process according to current guidelines and the experimental~     process integrating copeptin as a rule-out marker for acute myocardial infarction into~     management decisions. Main Hypothesis: Patients with suspected ACS who test negative for~     Troponin and negative for Copeptin at their initial presentation to the ED can safely be~     discharged (interventional process). They will not experience more major cardiac adverse~     events than patients who were managed by standard practise (control process)within 30 days~     after admission.~      The Investigators want to test Copeptin in patients with suspected acute coronary syndrome~     in whom the ECG is unspecific and the initial Troponin test is negative. Further patient~     care will be based on the Copeptin result. Patients with a negative Copeptin will be~     discharged into the ambulant care of resident cardiologists.Copeptin positive patients will~     be managed according to standard guidelines for the management of patients with ACS.~   "
118969|NCT01498718|"~     This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70~     years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost~     vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12~     influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza~     trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime~     followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe~     for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a~     better immune response than the seasonal TIV alone.~   "
118970|NCT01498705|"~     Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can~     lead to multiple complications including fever that is not infectious. Identifying the cause~     of fever can help physicians choose the best care for the patient to try and prevent further~     damage to the already injured brain. Bacterial infection is one possible cause of fever in~     the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary~     antibiotic use. Better screening tools for infection are being developed to help fight the~     problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of~     antibiotics in patients increases the risk of adverse events and overall healthcare costs.~     Procalcitonin (PCT) is one such screening tool which has been used previously to help tell~     apart bacterial and nonbacterial causes of infection in other disease states; however, PCT~     has not been studied in hemorrhagic stroke patients. The purpose of this study is to~     understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT~     can be a useful marker for infection in these patients.~   "
118971|NCT01498692|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™~     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo~     atherosclerotic coronary artery lesions. The lesions can be located in vessels that are~     smaller than average-sized.~   "
118972|NCT01498679|"~     A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate~     the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation~     powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult~     subjects of Asian ancestry currently treated with lowe to mid-strength inhaled~     corticosteroid or low-strength combination therapy.~   "
118973|NCT01498666|"~     The present clinical trial will examine the use of L. reuteri Protectis in children with~     functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri~     Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis~     of functional abdominal pain (FAP).~   "
118974|NCT01498653|"~     A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and~     safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered~     once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry~     currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA~     combination therapy~   "
118975|NCT01498640|"~     The objectives of this study are to assess the safety and efficacy of AA4500 in the~     retreatment of recurrent contractures in joints that were effectively treated with AA4500 in~     a previous Auxilium-sponsored Phase 3 study.~   "
118976|NCT01498627|"~     This study aims to assess whether the use of Cervarix® is associated with a modified risk of~     central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis,~     idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and~     dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by~     using the PGRx information system.~   "
121128|NCT01470456|"~     Primary Objective:~      Participants Achieving an Objective Response Rate (Cheson 2007)~      Secondary Objectives:~        -  Progression Free Survival~        -  Overall Survival~        -  Response Duration~   "
118977|NCT01498614|"~     Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes:~     Intervention Study With Affect School and Basal Body Awareness~      Background:~      Depression is common in patients with diabetes and is associated with impaired metabolic~     control. Alexithymia has been associated with depression, anxiety, stress related disorders~     and diabetes mellitus. Affect School (AS) is an intervention that may reduce depression and~     alexithymia according to previous research. Basic Body Awareness Therapy (BBA) is a~     stress-reducing technique.~      Purpose:~      Our aim is to: 1. Analyze the prevalence of depression and anxiety and the personality~     variables alexithymia and self image in diabetes patients. 2. Explore correlations between~     these variables and risk factors, including biochemical markers for diabetic complications.~     3. To evaluate an intervention with AS and BBA in patients with diabetes that scored high in~     psychometric self-report tests and at the same time showed impaired metabolic control.~      Method:~      A randomized controlled trial of 350 people with diabetes, 18-59 years, 56% men, 44% women.~     Base-line study: from medical records and the National Diabetes Registry - waist~     circumference, BMI, blood pressure, type and duration of diabetes, diabetes complications,~     other diseases, medications, exercise habits and smoking. Tests - A1c, blood lipids,~     cytokines, hormones, beta-cell antibodies, c-peptide, midnight cortisol (salivary).~     Self-report tests of psychological and personality variables: HAD, TAS-20, SASB.~     Intervention: patients with A1c ≥ 8 and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative~     self-image (SASB: AFF <284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA. AS: 8~     group sessions followed by 10 individual sessions. Instructors were a primary care physician~     and a psychotherapist. BBA: 9 group meetings and 6 individual sessions with a~     physiotherapist as instructor. Post intervention: Self report tests, A1c, cytokines,~     hormones, cortisol.~   "
118978|NCT01498601|"~     Hypothesis: The investigators hypothesize that the current oral protocol is sub-optimal and~     an enhanced protocol will decrease the incidence of hospital acquired pneumonia (HAP)in the~     acute, non-intubated, care-dependent, neurologically impaired, adult patient.~   "
118979|NCT01498588|"~     Previous studies have shown that chemotherapy has the same effect on treating breast cancer~     whether you receive it before or after surgery. Receiving chemotherapy before surgery,~     rather than after surgery, may allow the patient to have less extensive surgery. The purpose~     of this study is to identify new treatment regimens with better response rates and to find~     out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink~     the size of the patient's breast tumor and allow you to preserve your breast. Additionally,~     by receiving chemotherapy before surgery, the investigators will be able to determine if~     your cancer is responsive to chemotherapy.~   "
118980|NCT01498575|"~     The long-term goal of this research is to increase safe driving among novice teen drivers by~     increasing the quantity, quality and diversity of driving practice while accompanied by an~     adult. In order to achieve the long term goal of the study, the investigators have developed~     a web-based intervention program known as Teen Driving Plan (TDP) intended to support high~     quality driving practice.~   "
118981|NCT01498562|"~     Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may~     also assist in overcoming inherent or acquired resistance to gefitinib alone.~   "
118982|NCT01498549|"~     The overall goal of this study is to determine if atomoxetine treatment improves selective~     cognitive functions in abstinent cocaine users, compared to healthy controls. The study will~     also test if a functional variation of the NET promoter polymorphic region (NETpPR)~     moderates the cognitive effects of atomoxetine.~   "
118983|NCT01498536|"~     This study seeks to see if a 12-week diet and exercise program improves exercise ability,~     energy level, and quality of life.~   "
118984|NCT01498523|"~     Rationale: Recently, human, animal and epidemiological studies suggested that camel milk has~     a hypoglycaemic activity. However, a mechanism and reasons for this activity have not been~     sufficiently studied. Therefore, a study on a glycaemic and insulinaemic responses of~     regular camel milk and camel milk powder is needed.~      Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and~     camel milk powder in healthy adults.~      Study design: In a randomised, single-blind and cross over design, two hour post prandial~     glucose and insulin responses of 4 treatments (regular camel milk, camel milk powder,~     regular cow milk and glucose) will be measured . Those treatments will be consumed in a~     portion that contained 25g available carbohydrate. Finger-prick capillary blood samples will~     be taken at fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test~     product. Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the~     test product. The measurements will be conducted on 4 separate days with at least 2 days~     wash out.~      Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25~     kg/m2.~      Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and~     glucose. These are standardized to 600ml containing 25g available carbohydrate.~      Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin~     responses. Secondary parameters: amino acid composition and glycemic index.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: This intervention is non-therapeutic to the subjects. The risk associated with~     participation is negligible and the burden can be considered low. Before subjects are able~     to participate in this study they will have to fill out a brief questionnaire, and have~     their fasting blood glucose measured, in order to ensure they fit the inclusion criteria of~     the study. Once entering the study, each subject will have to visit the research centre 4~     times for the postprandial tests. On each measurement day, each subject will be required to~     have fasted for at least ten hours before (an overnight fast). Each subject will have 7~     finger-prick blood samples and 3 venapunctures taken during each visit. A maximum amount of~     50 ml blood is drawn per day.~   "
118985|NCT01498510|"~     The purpose of this study is to develop and evaluate an innovative, web-based psychosocial~     intervention for opioid-treated chronic pain patients who display aberrant drug-related~     behavior.~   "
118986|NCT01498497|"~     This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse~     events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after~     discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of~     Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the~     opportunity to better understand the natural course of eosinophilic esophagitis and define~     the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for~     chronic maintenance or intermittent treatment.~      All subjects who complete PR-021 will be offered the opportunity to participate in this~     study. The duration of this follow-up study is six months, during which subjects will visit~     the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,~     Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week~     20.~   "
118987|NCT01498484|"~     This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen~     (HLA) partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes~     (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.~   "
118988|NCT01498471|"~     This study is designed to evaluate the accuracy of the National Institute for Health and~     Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short~     term serious outcome when presenting in the emergency department (ED) with Transient Loss of~     Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs~     of heart failure, TLoC during exercise, family history of sudden cardiac death at an age <~     40 years and/or an inherited cardiac condition, new or unexplained breathlessness, heart~     murmur, absence of prodromal symptoms in any patient aged > 65 years.~   "
118989|NCT01498458|"~     Angiogenesis is essential for the growth of large tumor. A number of anti-angiogenic agents~     are currently under development. Bevacizumab, a humanised monoclonal antibody to vascular~     endothelial growth factor (VEGF), has been shown to improve disease free survival in first~     line metastatic breast cancer when associated with chemotherapy 1. Results of a randomised~     phase II trial combining sorafenib, a tyrosine kinase inhibitor targeting multiple tyrosine~     kinases including VEGFR1, VEGFR2, VEGFR3, with capecitabine have recently been reported 2.~     Compared to capecitabine plus placebo, progression-free survival in the capecitabine +~     sorafenib arm was significantly increased from 4.1 months to 6.4 months. Toxicities were~     also increased, with an incidence rate of grade 3/4 hand foot syndrome of 45% in the~     capecitabine + sorafenib arm compared to 13% in the capecitabine + placebo arm. The~     increased toxicity will most likely limit the clinical use of this regimen.~      Pazopanib is a potent, multi-targeted TKI of VEGFR-1, -2, -3, PDGFR-α and -β and c-kit and~     has recently been approved for the treatment of renal cell cancer in the U.S. In the EU, a~     positive opinion has been issued by the European Medicines Agency.~      A phase II study of GW786034 (pazopanib) in patients with recurrent or metastatic invasive~     breast carcinoma included 19 patients after a maximum of 2 lines of chemotherapy for~     advanced disease 3. Pazopanib 800 mg daily was given continuously.~      A clinically significant rate of stable disease (58%) was detected with a median TTP of 5.3~     months (95% CI: 1.8 - 9.0 months). Four patients treated with pazopanib had SD for ≥ 6~     months, for a clinical benefit rate (CBR), defined as rate of SD for ≥ 6 months or CR or PR,~     of 5/19 (26%), which is at least comparable to sunitinib and bevacizumab (CBR 16% and 17%,~     respectively).~      The pivotal study of full dose (800 mg) daily pazopanib in renal cell cancer reported hand~     foot syndrome of all grades in only 6% of patients 4. The optimally tolerated regimen (OTR)~     of pazopanib was determined when administered in combination with capecitabine and~     oxaliplatin in patients with advanced CRC 5. In patients who received capecitabine (850 mg~     twice daily) plus 800 mg once daily pazopanib combined with oxaliplatin, the incidence of~     hand foot syndrome of all grades was 24%.~      The present study will investigate the combination of pazopanib and capecitabine in advanced~     or metastatic breast cancer with the aim to develop a new treatment option with increased~     efficacy and tolerability.~   "
118990|NCT01498445|"~     The goal of this clinical research study is to learn if combining Spyrcel (dasatinib) and~     Dacogen (decitabine) can help to control CML. The dose level of decitabine will also be~     studied.~      Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia.~      Decitabine is designed to affect the mechanism that cells use to control the expression of~     certain genes, some of which are important in the progression of CML.~   "
118991|NCT01498432|"~     This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The~     fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas~     delivery in patients who require non-invasive ventilatory support following extubation on~     the Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the~     potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit.~     The purpose of this study is to answer a specific, clinically relevant question. That is~     whether Heliox21 helps to reduce the effort of breathing in the period following withdrawal~     of mechanically assisted ventilation in patients on the intensive care unit.~   "
118992|NCT01498419|"~     The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin~     plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.~   "
118993|NCT01498406|"~     Lupus is a disease in which the immune system, which normally fights infection, begins to~     attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune~     system attacks is called the autoantigen. Lupus can affect many parts of the body and often~     affects the skin, with immune cells attacking autoantigens in the skin and causing a rash.~     This rash is often visible to the public because it tends to occur on sun-exposed areas, for~     example a patient's face, chest, and arms. For this reason, among others, skin lupus can be~     a source of disability and poor health related quality of life in many patients with this~     disease. It is not completely understood why or how someone might develop lupus, however~     there are likely many reasons which include their genetics and also the kind of environment~     they live in.~      One such environmental factor, vitamin D, is more commonly known as a vitamin important for~     bone health. However, we are learning that vitamin D has effects all over the body, and is~     also important for a healthy immune system. Low levels of vitamin D have been associated~     with an increased risk of other autoimmune disorders such as diabetes and multiple~     sclerosis, and have also been found to be common in skin lupus patients.~      Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B~     radiation (UVB). The main source of vitamin D for most people is its production in the skin~     because the normal American diet is not high in vitamin D. However, patients with skin lupus~     tend to stay out of the sun because their rash is made worse by sunlight, which is thought~     to produce more of the autoantigens in the skin attacked by the immune system. Additionally,~     as skin doctors (dermatologists) we recommend sun protection to skin lupus patients to~     minimize sun-sensitivity and prevent flares of their skin disease. However we may be putting~     them at risk for low vitamin D status and even more severe disease. Another risk factor that~     puts skin lupus patients at risk for vitamin D deficiency is that these patients generally~     have darker skin types which blocks UVB and further limits vitamin D production in the skin.~      Given that skin lupus patients are at high risk for low vitamin D status as mentioned above,~     the investigators propose a research study that will provide information about vitamin D~     levels in these patients. The investigators seek to identify how many skin lupus patients~     have low vitamin D status and how vitamin D influences the natural history of this skin~     disease. Additionally the investigators will evaluate whether or not supplementation with~     high dose vitamin D will lessen the severity and negative quality of life impact of skin~     lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe~     over the counter method to replete and maintain a normal vitamin D status. Studies in other~     autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that~     high dose vitamin D supplementation improves disease severity. It is the hope of the~     investigators that this will also be observed in skin lupus patients.~      In summary, the investigators seek to move beyond establishing an association between~     vitamin D status and skin lupus. The investigators aim to elucidate the therapeutic benefit,~     if any, of vitamin D status on disease severity and quality of life while controlling for~     important factors that may influence vitamin D status. If the investigators are to show~     improvement in disease severity with vitamin D supplementation, this would be a~     cost-effective additional therapy to our standard clinical practice. Future research would~     also allow us to investigate other alternative markers of vitamin D deficiency and disease~     activity in skin lupus patients, a population at high risk for low vitamin D status and in~     need of further research.~   "
118994|NCT01498393|"~     The purpose of this clinical study is to improve the appearance of onychomycosis and~     morphology of the nail (fungal infection). The researcher can use a light based therapy to~     gently heat the toenail infected with fungus to improve the appearance of onychomycosis.~   "
118995|NCT01498380|"~     Dexmedetomidine is a sedative drug that has many benefits when given to children under~     anesthesia, such as improved pain relief and reduced agitation following their surgery. It~     is usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart~     rate and blood pressure that are occasionally seen when it is administered more quickly.~     However, this is often infeasible and usually inconvenient. The investigators aim to~     determine the dose of dexmedetomidine that can be given rapidly (over 5 seconds) without~     causing significant changes in heart rate and blood pressure. This will be the only study~     specific intervention.~   "
118996|NCT01498367|"~     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,~     centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and~     whether this intervention produces health and economic benefits when introduced without~     major changes to the existing organization of a large tertiary care center.~   "
118997|NCT01498354|"~     Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is~     anterior resection of the rectum or abdominoperineal resection. These techniques are~     associated with high mortality and morbidity and with genitourinary dysfunctions.~      To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its~     3-D vision system using a rectoscope, this procedure allows access to rectal tumors located~     up to 20 cm from the anal verge. It is associated with minimal morbidity and has few~     repercussions for anal continence.~      The use of 2-D high definition cameras and screens obtains images of a similar quality to~     3-D images. This means that from the surgical point of view the procedure known as TEO~     (transanal endoscopic operation) seems as practicable as classic TEM.~      Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus~     conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical~     facility, postoperative morbidity, quality of the surgical specimens, and cost.~      Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high~     definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.~      Disease studied: Rectal adenomas and adenocarcinomas in situ suitable for local surgery.~      Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal~     postoperative morbidity.~      Study population and total number of patients: Patients diagnosed with rectal tumor treated~     with curative intent (rectal adenomas and adenocarcinomas in situ). The total sample~     calculated for the trial was 36 patients, 18 in each group (TEO and TEM).~      Timing and expected finish date: After approval by the CEIC, the expected date for the~     inclusion of the first patient was August 2010. The study is expected to last 18-24 months.~   "
118998|NCT01498341|"~     The purpose of this study is to identify the number of persons in Denmark with the diagnose~     hypoparathyroidism, autosomal dominant hypocalcaemia or pseudohypoparathyroidism. Also the~     investigators want to identify the causes and symptoms of these patients and their~     prognosis.~   "
118999|NCT01498328|"~     The purpose of this research study is to find out whether adding an experimental vaccine~     called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can~     improve progression free survival (slowing the growth of tumors) of patients with relapsed~     EGFRvIII positive glioblastoma.~   "
119018|NCT01498081|"~     This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115~     will be tested versus placebo and active comparators. The safety and tolerability of AZD2115~     including investigations of clinically relevant systemically mediated effects will also be~     investigated.~   "
119019|NCT01498068|"~     The purpose of this study is to determine the effectiveness, safety and tolerability of~     telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated~     interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and~     treatment-experienced Russian participants with genotype 1 chronic hepatitis C.~   "
119020|NCT01498055|"~     To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung~     cancer.~   "
119000|NCT01498315|"~     Hysterectomy is one of the common operations in gynecology. With population aging in modern~     society, the incidence of these surgeries is expected to increase even more. One of the~     major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with~     pain, fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and~     varies according to the type of hysterectomy and the diagnostic procedure. Those hematoma~     increase the risk for infection. Diagnosis usually is not a clinical one unless symptoms~     occur, and then the diagnosis is made by CT or ultrasound. Number of interventions are~     mentioned in the literature to try and decrease post operative complications and infections,~     none have suggested effective enough. This is a prospective study which objective is to~     characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. The~     investigators will also try to identify preoperative, intraoperative and postoperative risk~     factors for infection of this hematomas. This identification might decrease the incidence of~     postoperative hematoma and infection.~   "
119001|NCT01498302|"~     RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease~     will come back in patients diagnosed with acute myeloid leukemia.~      PURPOSE: This research trial studies the comparison of laboratory test results for minimal~     residual disease in samples from patients with acute myeloid leukemia.~   "
119002|NCT01498289|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium,~     fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Combining more than one drug may kill more tumor cells. It is not yet known which regimen of~     combination chemotherapy is more effective in treating tumor cells.~      PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium,~     and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating~     patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.~   "
119003|NCT01498276|"~     Background:~      - Family-based approaches to reduce disease risk and promote healthy behaviors may be better~     than targeting individuals. Risk assessments based on family health history may help educate~     families on disease risks and encourage them to change physical activity and food choices.~     Specifically, researchers want to better understand the role of mothers in teaching healthy~     behaviors to their families.~      Objectives:~        -  To determine mothers influence on diet and health-related behaviors.~        -  To study an intervention tool that connects family health history and disease risk.~      Eligibility:~      - 18 years of age who have at least one child living at home.~      Design:~        -  Participants will complete a survey over the phone. The survey will take 30 to 40~          minutes to complete. The survey will collect family health history on heart disease,~          diabetes, colorectal cancer, and breast cancer.~        -  Researchers will give participants a Family Health Package (FHP). The FHP will provide~          information on family health history and disease risk. It will also recommend behaviors~          that can reduce health risks.~        -  Two weeks after sending the FHP, participants will complete a phone survey about the~          FHP materials and their social networks.~        -  Some participants will be invited to focus groups. The focus groups will explore diet~          and health behavior. They will look at food purchasing and preparation and meal~          sharing. The groups will also discuss attitudes toward healthy eating and physical~          activity. Each focus group will last 1 to 2 hours.~        -  Participants will be asked to complete an electronic survey regarding participants~          health status, causal health beliefs, risk perceptions, and intentions to communicate~          health information.~        -  Then, participants will have the opportunity to use the electronic version of the FHP,~          which will assess family health history.~        -  After using the FHeP, participants will complete a short electronic survey to identify~          knowledge and understanding gained from the use of the application, changes in~          communication intentions, and suggestions for improvements to the application.~        -  Upon completion of the electronic portion of the study, a study team member will~          conduct a semi-structured interview to allow the participants to qualitatively evaluate~          their user experience, including satisfaction and usefulness.~        -  This study process will take approximately 60-90 minutes.~   "
119004|NCT01498263|"~     Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged.~     These caregivers experience significant distress associated with caregiving, which may be~     particularly salient in the context of inherited conditions. Previous studies have not~     examined caregiving from a network perspective, nor have they considered how cognitive and~     emotional responses, such as caregivers worry for themselves and relatives acquiring the~     disease or guilt related to the genetic etiology of their child s illness, as possible~     stressors; the current project fills this literature gap.~      Caregiving processes may vary across type of illness and the life course. In illnesses that~     impact children, parents and grandparents may take on caregiving roles whereas in conditions~     that impact adults, spouses and adult children may provide care. Caregivers must adapt to~     the strain of caring for their affected relatives and this adaptation may differ depending~     on caregiver roles. The caregiver s support network may influence adaptation, impacting the~     health and well-being of patients, their caregivers, and other relatives.~      This project, comprised of 4 substudies, will examine social contexts surrounding families~     involved in caring for individuals with chronic inherited conditions from a relational~     perspective. Surveys and interviews will assess participants cognitions and emotions about~     the disease, caregiving burden and caregiving/support network systems. In addition,~     biomarkers will be considered in 2 substudies to examine how caregiving roles and~     expectations impact health among caregivers.~      We aim to recruit at least 3100 participants through residential/daycare centers, advocacy~     groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological~     and non-biological adult relatives of patients and normally developing controls to construct~     and evaluate caregiving/support network systems. This project will use a social network~     framework to develop and adapt common measures of caregiving roles to evaluate burden,~     perceptual bias, and unmet expectations in caregiving. The psychometric properties of these~     new measures, characteristics of family caregiving and support networks, and how these~     network characteristics are associated with caregiving strain and well-being, including~     biomarkers of physical health, will be investigated. The moderating role of family members~     cognitions and emotions and disease context will be considered. Findings will guide future~     research to develop network-based interventions promoting positive adaptation to the~     presence of inherited conditions in families through improved social environments and coping~     skills.~   "
119005|NCT01498250|"~     Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of~     cancers. This study will be an exploratory analysis of miRNA expression in basal cell~     carcinoma by miRNA expression profiling using microarrays.~   "
119006|NCT01498237|"~     The purpose of this research study is to evaluate whether a new technology called~     intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the~     uterus.~   "
119007|NCT01498224|"~     This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure~     Sealant compared to sutures for preventing incision leakage within the first 7 days of~     cataract surgery.~   "
119008|NCT01498211|"~     Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this~     density is used to diagnose small fiber neuropathy, despite the absence of normative data in~     a selected normal population. To establish a normative set of data matched for age and sex~     is absolutely needed to evaluate the sensibility and specificity of this test.~   "
119039|NCT01497808|"~     The primary objective is to determine the maximum tolerated hypofractionated radiotherapy~     dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in~     metastatic melanoma patients without brain involvement The secondary objectives are to~     determine late toxicity, immune-related clinical responses and immune pharmacodynamic~     changes after hypofractionated radiotherapy followed by ipilimumab~   "
119085|NCT01497197|"~     This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label,~     comparative trial which primary objective is to generate data on the ovarian stimulation~     profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced~     reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).~   "
119009|NCT01498198|"~     The overall goal of this proposed randomized study is to determine if surgery at the time of~     diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails)~     results in shorter times to claim closure. The study will examine how often non-operative~     management is successful in resolving symptoms and allowing subjects to return to work~     without surgery. The investigators will also examine if there are subject, tear or~     work-related characteristics that affect the outcome of rehabilitation or expedited surgery~     and predict whether patients should be referred to operative or non-operative management at~     time of assessment. At study completion, the investigators expect to be able to definitively~     state the best management for subjects with these less serious RC tears.~      The specific research questions to be addressed are as follows:~        1. In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1~          cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or~          expedited surgery affect time to claim closure?~        2. Are there subject, tear or work-related characteristics that affect which patient~          management approach will be most effective and efficient?~   "
119010|NCT01498185|"~     To obtain safety and tolerability information in patients with type 1 diabetes where~     Dapagliflozin is added on to Insulin (for 14 days)~   "
119011|NCT01498172|"~     In this study, the investigators would like to assess how intravesical BCG schedules after~     immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together~     with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell~     responses both systemically and locally in the bladder.~   "
119012|NCT01498159|"~     This research evaluates a diabetes management intervention designed to improve medication~     adherence and intensify therapy to reach goals in blood sugar, blood pressure, and~     cholesterol levels. This study will determine the benefit and cost of adding community~     health promoters to pharmacist disease management services. If there is benefit, then this~     approach may help reduce the burden of diabetes and its related complications among~     minorities with diabetes.~   "
119013|NCT01498146|"~     The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous~     unexplained stroke. It uses long term monitoring of the heart of up to three years,~     searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.~   "
119014|NCT01498133|"~     BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control~     outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care~     Unit), but can trigger bacterial resistance. The objective of this study was to determine~     whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin~     Resistant Staphylococcus Aureus) with their mothers could be an effective alternative for~     biological control of bacterial colonization.~      METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals~     in São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay~     >4 days, newborns colonized by Staphylococcus aureus and/or Staphylococcus~     coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these~     bacteria. Randomization was performed using a computer generated random numbers algorithm.~     Allocation to intervention and control groups was performed for each eligible newborn using~     a sealed opaque envelope. In the intervention group (n = 53) mother-infant skin-to-skin~     contact was held twice a day. The control group (n = 49) received routine care without~     skin-to-skin contact. There was no masking of newborn's mothers or researchers, but the~     individuals who carried out bacterial cultures and assessed results were kept blind to group~     allocation.~      The primary outcome was decolonization of newborns' nostrils after 7 days of intervention.~     Safety was assessed by monitoring vital signs of newborns during the intervention. The~     secondary outcome was emergence of late onset presumed sepsis until the end of~     hospitalization period or 28 days of life, whatever happened first.~      FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)~   "
119015|NCT01498120|"~     This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up~     study of monotherapy administration of rotigotine transdermal patch in adolescents with~     Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability~     of Rotigotine treatment in adolescents with RLS.~   "
119016|NCT01498107|"~     This pilot study investigates a new platform for supporting online interventions for common~     mental health problems called SilverCloud. It was developed from insights into interactive~     system design to address the problem of high attrition rates and poor engagement with online~     interventions. Through a range of methods, the study considers the role of four design~     strategies in engaging users in cognitive behavioural therapy. A service-based study, it~     concentrates on a clinical population with mild or moderate depression. Clinical outcome~     measures will be taken pre and post intervention use; demographic data of who did and did~     not choose the intervention collected, patterns of usage will be extracted from the log data~     and analysed; and qualitative interviews will be done to understand the relationship between~     patterns of usage and levels of engagement. The findings will be used to inform further~     developments of this and other online interventions and contribute to the development of~     methods for assessing online interventions.~      The objectives of the pilot study are:~        -  To evaluate engagement with the online intervention in a realistic primary mental~          health care setting~        -  Assess engagement from multiple perspectives, including clinical efficacy and~          interaction design~        -  Contribute to further development of the online intervention~        -  Support preparation for a full-scale clinical trial~      Research questions include:~        -  Does the online intervention decrease symptoms of depression?~        -  Who chooses to use the online intervention?~        -  What are the patterns of use of the online intervention?~        -  How successful are the four design principles, personal, interactive, supportive and~          social, in supporting engagement?~   "
119017|NCT01498094|"~     Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny~     airways within the lungs called bronchioles. At present the standard care of hospitalized~     children with bronchiolitis is oxygen via nasal prongs. In this study the investigators~     would like to compare standard ward management with a new method of delivering oxygen called~     high flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened~     oxygen through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience~     suggests that HFNOT eases the child's work of breathing and reduces need for ICU admission~     and invasive respiratory support.~   "
119021|NCT01498042|"~     Stroke is among the most disabilitating diseases worldwide in terms of numbers affected and~     its consequences. A relatively new and well documented treatment of acute ischemic stroke~     today is tPA (tissue plasminogen activator; will be called thrombolysis from now on)~     Unfortunately only a minority of patients is given this treatment.~      The large randomised controlled trials that investigated the safety and efficacy of~     thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. In~     an aging population in the western world it will be of importance to investigate whether~     this treatment is safe and effective in this group.~      Both Sorlandet hospital Kristiansand Norway and Bergen hospital have administered~     thrombolysis to selected patients over 80 years the last years. In addition there has been a~     registration of patients in stroke registers at both locations. This lays a foundation for~     further investigation. In association with Bergen the investigators have included 77~     patients over 80 years treated with thrombolysis. In addition the investigators have 85~     patients treated with tpa below 80 years. In our cohort the investigators are going to~     compare outcome in the 2 groups. In addition the investigators are going to perform a~     regression analysis of selected variables to see if there is an association of those~     variables with predefined outcome measures. Our outcome measures is as follows: mRS=6~     (death)and mRS 0-1(good outcome) on 3 months control. The third outcome measure will be~     developement of sICH secondary to tPA treatment. As definition of sICH we have chosen the~     same definition as Ecass.~   "
119022|NCT01498029|"~     The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which~     cartilage is harvested from non-critical regions of articular cartilage, but then~     immediately morcellated and loaded onto a polymer membrane-scaffold, which is subsequently~     used to fill the chondral defect. The autograft-membrane composite is fixed to the defect~     with a biodegradable staple.~      The investigators aim to evaluate this new technique through a pilot clinical trial~     involving 36 patients randomized into microfracture and CAIS treatment arms (randomisation~     ratio 1:2), with a minimum follow-up of 1 year, using both clinical and radiological~     (magnetic resonance imaging) outcomes. If the results of this pilot trial are successful,~     the investigators plan to expand the study by recruiting more patients to achieve a~     suitably-powered trial.~      Primary hypothesis 1: That functional scores will increase by at least 0.5 SD over~     pre-operative values, by 1 year following the CAIS procedure~      Primary hypothesis 2: That articular cartilage height will have a sustained increase of at~     least 2 mm at 1 year following the CAIS procedure~      Primary hypothesis 3: That functional scores in the CAIS group will be equivalent or~     superior to those in the microfracture group~   "
119023|NCT01498016|"~     Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic~     hematopoietic stem cell transplantation for patients with acute leukemia. Though the~     pharmacokinetics data are available for population from America, Europe and Japan or Korea~     in Asia, there are no data in Chinese population. It is shown that high Bu concentration are~     associated with the toxicity such as veno-occlusion disease and lower concentration is~     correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy~     to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain~     the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct~     the pharmacokinetic study in Chinese population.~   "
119024|NCT01498003|"~     Periprocedural myonecrosis or infarction are associated with short, intermediate, and long~     term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural~     CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the~     investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence~     of periprocedural infarciton in elective patients with long coronary lesions treated by~     overlapping use of drug-eluting stents.~   "
119025|NCT01497990|"~     This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT)~     burn patients.~   "
119026|NCT01497977|"~     The goal of the study was to assess the impact of soy and red clover derived phytoestrogens~     on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen~     content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the~     estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis~     was that they can reduce the levels of serum lipids.~      Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and~     triglycerides in blood, before treatment and in six months periods, throughout 18 months.~     The study involved 74 healthy postmenopausal women, divided into three groups. The first~     group of 23 patients received red clover derived isoflavones, the second one with 26~     patients got soy derived phytoestrogens, while the third, control group with 25 patients,~     was without medications.~   "
119027|NCT01497964|"~     Primary Objective:~      - To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response~     rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in~     patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens~      Secondary Objectives:~        -  To determine the RD of cabazitaxel when administered as a single agent every 3 weeks~        -  To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks~        -  To estimate the overall survival (OS) and progression free survival (PFS)~        -  To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1~   "
119028|NCT01497951|"~     Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to~     re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical~     removal is not always possible. The photodynamic therapy uses a special substance, which is~     absorbed in cells, and thereafter activated by a defined light. The aim of this study is to~     compare the photodynamic therapy in potentially malignant lesions to a placebo. The~     investigators assume a significant better result in photodynamic therapy then treatment with~     a placebo.~   "
119040|NCT01497782|"~     With a worldwide proliferation of simulation centers, it is essential to explore the optimal~     setting for laparoscopic training and investigate different learning approaches, e.g. a~     self-directed approach. Therefore, the researchers investigated the following in a~     randomized controlled trial: the impact of instructor feedback vs. an independent,~     self-directed approach when training a complex operational task on a laparoscopic virtual~     reality simulator.~      The study hypothesis is that instructor feedback has a pivotal effect on surgical skills~     when training on a virtual reality simulator.~   "
119029|NCT01497938|"~     Introduction:~      The purpose of the pivotal In Home study is to collect clinical data on the safety and~     efficacy of the Paradigm LGS System in the actual use environment and by the intended use~     population. ASPIRE is a multi-center, in home, randomized parallel adaptive study design~     with type 1 diabetes. The study will compare A1C and CGM based nocturnal hypoglycemic events~     in a treatment arm to a control arm. Arms are defined as:~        -  Treatment Arm (LGS ON) using Paradigm® VEO™ Pump~        -  Control Arm (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump~      The study's objectives are two-fold:~        1. The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS)~          is safe and is not associated with glycemic deterioration, as measured by change in A1C~          from baseline to end of study participation.~        2. The second study objective is to demonstrate that home use of Low Glucose Suspend (LGS)~          is associated with reduction in nocturnal hypoglycemia when patients fail to respond.~      Primary Safety Endpoint:~      The change in A1C from randomization to the end of the treatment period will be used to~     demonstrate that the automatic insulin delivery suspension (LGS ON) does not result in an~     unacceptable worsening of glycemic control.~   "
119030|NCT01497925|"~     This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors~     with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize~     that the combination will result in greater tumor cytotoxicity with an acceptable toxicity~     profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of~     action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20~     and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that~     this will be particularly relevant in CRPC.~   "
119031|NCT01497912|"~     Patients with type 1 diabetes are at increased risk of vascular complications both in the~     micro- and macrocirculation. Hyperglycemia plays a major role in the development of these~     vascular complications, but other factors such increased platelet adhesion and aggregation,~     elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin~     generation, dyslipidemia and endothelial dysfunction may contribute.~      Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in~     individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and~     vasculature that are independent of their lipid-lowering properties.~      The aim of the present study was to investigated the effects of intensive~     LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary~     variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia.~     Furthermore, the effects of atorvastatin therapy on skin microvascular function was also~     investigated.~   "
119032|NCT01497899|"~     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)~     FDC in HIV-1 infected, antiretroviral treatment-naive adults.~   "
119033|NCT01497886|"~     Despite the abundance of stroke education materials available, studies continue to reveal~     severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention~     measures). Expensive mass media stroke education campaigns are not sustainable for this~     purpose, particularly in economically disadvantaged populations. Instead, the investigators~     propose to intervene in school classrooms with children aged 9 to 11 years, to teach the~     five cardinal stroke symptoms, the correct course of action when they occur, and to~     highlight the potential therapeutic benefit of early hospital arrival, with the intent that~     the children will then educate their parents. To help accomplish this, the investigators~     have developed a program called Hip Hop Stroke (HHS), which is comprised of rap songs and~     two animated musical cartoons that incorporate stroke knowledge.~      Hypotheses:~      Hypothesis 1. No differences in baseline knowledge will exist between the parents assigned~     to the intervention and control arms or between the children assigned to the intervention~     and control arms.~      Hypothesis 2. Children in the intervention arm will demonstrate greater knowledge~     immediately after and at three months after the intervention concerning stroke symptom~     identification and response compared to those in the control arm.~      Hypothesis 3. Compared to students in the Control condition, children in the intervention~     arm will be more likely to communicate stroke information to their parents (assessed at~     1-week follow-up).~      Hypothesis 4. In homes in which such communication has been enacted, parents in schools~     assigned to the intervention arm will demonstrate greater ability to name the symptoms of~     stroke and appropriate action, compared to their baseline knowledge, at 1 week and at 3~     months follow-up, compared to parents in the control arm.~   "
119034|NCT01497873|"~     The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5~     days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung~     cancer.~   "
119035|NCT01497860|"~     The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink~     or slow the growth of pediatric low-grade gliomas that have either returned or are~     continuing to grow.~      Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in~     patients with pediatric low-grade glioma. It has been specifically synthesized to broaden~     its therapeutic spectrum and decrease the neurotoxicity associated with related agents.~   "
119036|NCT01497847|"~     Purpose:~        -  identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome~          (PI-IBS) development after an episode of traveler's diarrhea~        -  identification of systemic (serum) and local (biopsy) changes in infectious and~          immunological activity during infection and correlation with Irritable Bowel Syndrome~          (IBS) symptoms, persisting after traveler's diarrhea~      Design:~        -  4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12~          months after traveling~        -  at each study visit following investigations: blood collection, stool collection,~          questionnaires, rectal biopsy~   "
119037|NCT01497834|"~     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032~     combination therapy in Japanese subjects.~   "
119038|NCT01497821|"~     This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in~     subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or~     who have refractory disease following at least two prior therapies. The purpose of the study~     is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective~     response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two~     Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to~     determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated~     dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall~     response rate in subjects treated at the MTD established in Part 1 for either every two week~     or every three week dosing.~   "
119041|NCT01497769|"~     This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine~     MVA85A administered by the aerosol inhaled route and the intradermal route in healthy~     BCG-vaccinated adult subjects.~   "
119043|NCT01497743|"~     Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and~     anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely~     debilitating and even life-threatening. Some problems associated with GIT disorders may~     include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing,~     constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract),~     diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines),~     and the inability to control your bowel movements.~      Probiotics are the good bacteria normally found in your digestive tract. Our group is~     looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of~     these symptoms in scleroderma patients that have GIT disorders.~   "
119044|NCT01497730|"~     This post-marketing investigation will evaluate the functional knee performance of Subjects~     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one~     of four contemporary knee configurations from different manufacturers will be pooled to~     establish a contemporary dataset.~      The primary objective of this study is to evaluate the functional performance as measured by~     the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score~     (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year~     post-operation. This will be carried out for all four implant configurations. The final~     endpoint is a 2-year evaluation.~   "
119045|NCT01497717|"~     Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease,~     classified among the vasculitides. The clinical manifestations include mucocutaneous~     lesions, articular, ocular, vascular, gastrointestinal and/or central nervous system~     involvement.~      The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that~     TNF-α may play an important role in the pathogenesis of the disease.~      To date, case reports and small open-short term studies report the efficacy of anti-TNFα~     therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous~     involvement in Behcet.~      There are no double blind long term studies on larger number of patients regarding the~     efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of~     the disease.~   "
119046|NCT01497704|"~     This protocol will be divided into two parts: Part 1 will evaluate the safety and~     pharmacokinetics of three doses of YN968D1 after a single administration followed by a~     28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary~     efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All~     subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only~     safety monitoring and bimonthly assessments for progression, if the product is well~     tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled~     in this clinical trial.~   "
119047|NCT01497691|"~     Previous investigations and anecdotal experience have shown safety and utility of~     Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for~     the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect~     in children with respiratory insufficiency, emergency department and ICU stays may be~     shortened, and the need for more invasive and dangerous airway procedures may be decreased.~     This would result in a change in the standard of care for asthma treatment in emergency~     departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction~     with current standard of care therapies, in acute moderate to severe asthma exacerbations~     will lead to a more rapid improvement in patient ventilation, faster resolution of~     respiratory distress, and overall improved secondary outcomes.~   "
119048|NCT01497678|"~     The objective of the study is to assess mechanical strength and function in subjects~     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of~     biologic scaffolds for the restoration of both mechanical strength and function in these~     subjects. This study will formally evaluate healing and return of function after an~     extracellular matrix device implantation in 40 male and female subjects participating at 4-5~     military sites who suffer from injury with loss of skeletal muscle tissue. The University of~     Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating~     Center for this multi-site study.~   "
119049|NCT01497665|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in~     patients with brain metastases from non-small cell lung cancer (NSCLC).~   "
119050|NCT01497652|"~     The present pilot study is designed to assess the extent to which rasagiline may improve~     cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary~     objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients~     who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to~     assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.~   "
119051|NCT01497639|"~     The aim of the study is to compare the efficacy and the safety profile of the newly~     introduced interleaving stimulation mode to those of the standard double monopolar~     stimulation mode during pallidal deep brain stimulation of primary generalized or segmental~     dystonia.~   "
119052|NCT01497626|"~     This study is for patients with an advanced type of cancer for which no curative treatment~     exists.~      The purpose of this study is to test the safety and efficacy of the combination of the study~     drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for~     the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins,~     lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral~     pill given by mouth once every day. Lapatinib is approved by the FDA for patients with~     breast cancer.~      Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By~     inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their~     death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is~     approved by the FDA for patients with multiple myeloma and mantle cell lymphoma.~      This research is being done because it is not known if the combination of lapatinib and~     bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in~     animal studies the combination of the two drugs was much more effective than either drug~     alone.~      As part of this study biopsies will be taken of patients' tumors before any treatment, after~     starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators~     want to study what markers inside tumors may relate to how well these two medications work.~     These biopsies are required as part of the study.~   "
119053|NCT01497613|"~     Although technology offers great potential for enhancing the health and well-being of older~     adults, robust studies are needed to quantify the value of technology and further the~     investigators understanding of barriers to technology access among older adults and of~     strategies that are effective in removing these barriers. This cross-site randomized field~     trial will evaluate a simple to use Personalized Reminder Information and Social Management~     System (PRISM) designed to support social connectivity, memory, skill building and resource~     access for older adults. The PRISM system (PRISM C condition) will be compared to an~     notebook information control condition (PRISM B condition). The target population is older~     adults who live at home alone and are at risk for isolation. The goal of the study is to~     gather systematic evidence about the value of technology for older adults and to identify~     factors that affect use and usability, acceptance and technology adoption. The investigators~     will also gather longitudinal data on the benefits of the system. Participants aged 65 - 85~     years (100 per site) will be randomly assigned following baseline assessment to one of two~     conditions: PRISM C condition where participants receive the technology system or the PRISM~     B condition only control where participants receive a notebook that includes information~     similar to that provided in PRISM C (e.g., resource guide). The categories of information~     provided in the notebook is similar to the features provided on the system. Participants~     will include males and females who do not have a home computer and who have limited Internet~     experience. The intervention period is 12 months. A battery of measures that includes~     demographic information, attitudes towards technology (including computer self-efficacy and~     computer comfort), technology, computer and Internet experience, functional independence and~     well-being, emotional well-being social support/isolation, and quality of life will be~     administered at baseline, and 6 and 12 months post randomization. In addition, the~     investigators will assess cognitive abilities at baseline and twelve months. The~     investigators will also gather data regarding technology use and social interactions via a~     brief telephone interview at 18 months post randomization.~   "
119054|NCT01497600|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2~     diabetes of various race and ethnicity.~   "
119055|NCT01497587|"~     This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of~     insulin detemir in healthy Taiwanese subjects.~   "
119056|NCT01497574|"~     This trial is conducted in Europe. The aim of this trial is to compare the within-subject~     variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in~     children and adolescents with type 1 diabetes.~   "
119057|NCT01497561|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in~     subjects with type 2 diabetes.~   "
119058|NCT01497548|"~     Primary Objective To determine the efficacy of Methylphenidate as add on therapy to~     mirtazapine in the treatment of depression in cancer patients under palliative care~     Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early~     reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.~      Secondary Objective~        1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the~          treatment of anxiety in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant~          early reduction in anxiety score of HADS than Mirtazepine alone treated subjects~          between baseline and Day 3.~        2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          reducing distress in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant~          early reduction in distress score of distress thermometer than Mirtazepine alone~          treated subjects between baseline and Day 3.~        3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          improving function in cancer patients under palliative care.~           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in~          the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone~          treated subjects between baseline and Day 3~        4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in~          reducing somatic complaints in cancer patients under palliative care.~      Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early~     reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale~     (VAS) for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.~   "
119059|NCT01497535|"~     This trial is conducted in Europe. The aim of this trial is to compare the within-subject~     variability of insulin detemir to that of another basal insulin analogue, insulin glargine~     in healthy volunteers.~   "
119060|NCT01497522|"~     The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as~     an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted~     to support registration of the fixed-dose combination of vildagliptin and metformin for the~     treatment of Type 2 diabetes mellitus (T2DM) in Japan.~   "
119061|NCT01497509|"~     Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding~     outcomes, many previous studies feature major design limitations that preclude widespread~     applicability of findings. Some fail to control for the precise pharmacologic composition of~     the epidural infusion, including whether or not an opioid, such as fentanyl, is even used at~     all in addition to local anesthetic or whether a combined spinal/epidural or purely epidural~     technique is used. The drugs used in epidural infusions not only have different mechanisms~     of action and lipophilicities but are also transferred across the placenta in varying~     proportions, with one study identifying an umbilical vein/maternal vein ratio of 0.94 for~     epidural fentanyl and 0.30 for bupivacaine, and another finding significantly different~     umbilical cord fentanyl concentrations among neonates whose mothers' epidural infusions~     contained >150 micrograms fentanyl, <150 micrograms, or none at all. It is also possible~     that the same total dose of epidural fentanyl could affect neonates differently depending~     upon the time course over which it was administered - namely, whether fentanyl is included~     in both the initial epidural bolus and the subsequent infusion or solely in the infusion. In~     two studies, mean umbilical vein concentrations of fentanyl did not correlate with total~     epidural infusion time, but both of these featured sample sizes fewer than 30, necessitating~     further research. Another limitation of some previous studies is defining success solely as~     the time to cessation of breast-feeding. Questionnaires mailed to mothers months or even~     years postpartum may generate unreliable data. If epidural medications truly mediate some~     physiologic effect upon breast-feeding, then the optimal study period is immediately~     post-delivery, specifically before the drugs are cleared from the maternal and neonatal~     circulations. After hospital discharge, many new factors - such as a mother's need to return~     to work or lack of social support - begin to confound the picture of breast-feeding success.~     Full-time employment outside the home has been significantly associated with decreased~     likelihood of breast-feeding at 6 months postpartum. Some studies also fail to control for~     intent to breast-feed at the time of hospital admission, number of infants previously~     breast-fed, or labor duration. Failure to account for oxytocin augmentation of labor is also~     problematic, as intravenous intrapartum oxytocin infusion has been shown to decrease a~     woman's endogenous serum oxytocin concentration on the second day postpartum in a~     dose-dependent fashion, which can subsequently impair milk release and, thus, decrease~     breast-feeding success.~      Epidural analgesia may worsen breast-feeding outcomes by attenuating neonatal exhibition of~     neurobehaviors tied to feeding, such as sucking, rooting, and swallowing, during the~     immediate postpartum period. This critical period is when mother and baby make their first~     attempts at breast-feeding and set a precedent for subsequent interactions. Neonatal feeding~     behavior in the early postpartum period is an important predictor of long-term~     breast-feeding success; those babies who feed most vigorously during their first days of~     life are significantly more likely to still be breast-feeding at 3 or 6 months than those~     who exhibit any lesser degree of breast-feeding enthusiasm. Radzyminski et al. found no~     significant dose-response relationship for either epidural bupivacaine or fentanyl regarding~     neonatal feeding behaviors, and Porter et al. found no significant effect of epidural~     fentanyl, mean dose 184 micrograms, upon neonatal APGAR scores, incidence of respiratory~     depression, or NACS scores (Neurologic and Adaptive Capacity Scores) at 2 or 24 hours~     post-delivery. Beilin et al. found that neonatal NACS scores were significantly lower when~     mothers' epidural infusions contained greater than 150 micrograms total epidural fentanyl~     than when they contained only bupivacaine.~      In this randomized, controlled, double-blinded study, we investigate whether intrapartum~     epidural fentanyl significantly decreases the likelihood of breast-feeding at hospital~     discharge and increases the incidence of neonatal deficits in latching on to the breast and~     audibly swallowing during the first three hours of life. We hypothesize that these effects~     will be dose-dependent but will have no relation to the time course over which the epidural~     fentanyl is administered. We also investigate whether oxytocin augmentation of labor and~     decreased amount of skin-to-skin contact during the first hour of life are associated with~     significantly decreased breast-feeding rates at hospital discharge.~   "
119062|NCT01497496|"~     The main purpose of this study is to see if the combination of ofatumumab with high dose~     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can~     help people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period~     of time. Researchers also want to find out if the combination of ofatumumab with~     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe~     and tolerable.~   "
119063|NCT01497483|"~     This study will address the following question: Does cyclosporine affect the~     pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine~     inhibits the organic anion transporter required for pravastatin transport into the liver,~     thus increasing pravastatin levels in the blood. The investigators hypothesize that this~     inhibition will vary among people based on genetic differences. This knowledge is important~     to help develop safer and more effective drug therapy with reduced side effects.~   "
119064|NCT01497470|"~     The primary goal of this study is to determine if custirsen has an effect on the way the~     body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The~     study will also evaluate if custirsen influences the way the body distributes and gets rid~     of carboplatin (another standard administered chemotherapy) and will measure custirsen blood~     levels in this cancer population. Finally, the study will evaluate the safety and~     tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.~   "
119065|NCT01497457|"~     MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch~     of Douglas. The investigators think that the localization of the rectal tumor in function of~     this anatomic mark could be decisive for pre-operative assessment.~   "
119066|NCT01497444|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells.~      PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib~     tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in~     treating patients with advanced kidney cancer or liver cancer that cannot be removed by~     surgery.~   "
119067|NCT01497431|"~     This randomized phase I trial studies the side effects and the best dose of~     Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy~     participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The~     use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium~     compounds, may prevent prostate cancer from forming.~   "
119068|NCT01497418|"~     Collect and evaluate the long term safety data.~   "
119100|NCT01496989|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human~     IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in~     low-risk for HIV-uninfected healthy adults.~   "
119069|NCT01497405|"~     This study compares the effects of standard HIV test, treat and retain (TTR) practices with~     TTR plus a woman-focused enhanced strategy--Women's Health CoOp (WHC+) intervention)~     targeting hard-to-reach and vulnerable alcohol and other drug (AOD)-using women to determine~     if the WHC+ intervention is more efficacious than TTR alone in reducing HIV risk behavior.~     Additionally, the study will determine whether HIV positive women in the WHC+ arm are more~     likely to follow through with referrals for further medical evaluation and linkages to HIV~     treatment and other care than women in the TTR arm.~   "
119070|NCT01497392|"~     This phase I trial is studying the side effects and best dose of dovitinib lactate when~     given together with gemcitabine hydrochloride and capecitabine in treating patients with~     advanced or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving dovitinib lactate together with combination chemotherapy may kill more~     tumor cells~   "
119071|NCT01497379|"~     Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones~     (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.~   "
119072|NCT01497366|"~     This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in~     combination with ribavirin (RBV) administered for 12 weeks compared with pegylated~     interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C~     (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR)~     12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and~     if non-inferiority was demonstrated, the study was then allowed to test for superiority.~   "
119073|NCT01497353|"~     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes~     after birth) as an indirect measure of the volume of placental transfusion in a group of~     healthy and fullterm newborns, placed at the level of the introitus versus another group~     placed on the abdomen of the mother.~   "
119074|NCT01497340|"~     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes~     after birth) as an indirect measure of the volume of placental transfusion in a group of~     healthy and fullterm newborns, placed at the level of the introitus versus another group~     placed on the abdomen of the mother.~   "
119075|NCT01497327|"~     This study will be conducted in Hepatitis C positive patients to determine whether the~     pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with~     normal hepatic function, which may allow inclusion of patients with cirrhosis and varying~     degrees of hepatic dysfunction in future clinical studies.~   "
119076|NCT01497314|"~     The purpose of this study is to show that a low lactose milk-based infant formula supports~     normal growth in healthy term infants.~   "
119077|NCT01497301|"~     Much evidence exists that new, more effective methods of delivering care to diabetics are~     necessary. In our current system of delivering care, diabetes care is often done in the~     context of multiple other issues addressed during a regular office visit. Providers often~     lack the time to properly educate patients on diabetes self management topics. This project~     hopes to show that group visits can improve clinical outcomes, patient satisfaction,~     provider satisfaction, and patient's self management knowledge, while decreasing cost. This~     group visit method can make care more patient-centered and team based which is in alignment~     with our organization's goal of becoming a true patient centered medical home. If~     successful, this could expand to our other family medicine clinic sites and provide a~     valuable learning opportunity for the family medicine residents at OHSU.~      The investigators will first identify newly diagnosed diabetics (diagnosed within the last~     12 months) at the South Waterfront and Gabriel Park family medicine clinics using EPIC. The~     investigators will invite those diabetics identified from the South Waterfront clinic to~     participate in 6 group visits that will follow a curriculum that the investigators created~     based on the National Standards for Diabetes Self Management Education and the ACP Diabetes~     Care Guide. This curriculum will address basic pathophysiology of diabetes, the ABCs to~     Better Diabetic Care as defined by the ACP Diabetes Care Guide, setting goals, nutrition,~     exercise, diabetic medications, and complications of diabetes. This intervention group will~     be compared to a control cohort identified at the Gabriel Park clinic that will continue to~     receive standard diabetes care from their primary physician. The investigators will look at~     and compare clinical outcomes (Hemoglobin A1C, blood pressure (BP), and LDL cholesterol~     levels), adherence to recommended preventive measures for diabetics (foot exams, eye exams,~     yearly microalbumin, and immunizations), patient and provider satisfaction, as well as cost.~     Cost data will be collected using EPIC to look at the costs involved in group visits~     compared to the cost of delivering diabetic care through the standard individual medical~     appointment. The investigators may also use EPIC to look at utilization of specialty~     services, emergency room visits, and inpatient admissions and compared utilization across~     groups.~   "
119078|NCT01497288|"~     The overall clinical trial objective is to gain information about the Pharmacokinetics (PK)~     of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male~     and female subjects are planned to be randomized in the trial. Subjects will be randomized~     to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose~     INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects~     will be hospitalized over a period of total 5 days, where safety assessments and~     pharmacokinetic samplings will be conducted.~   "
119079|NCT01497275|"~     The purpose of this study is to evaluate the effects (good and bad) of the combination of~     ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory~     mantle cell lymphoma.~      Zevalin is a monoclonal antibody that is combined with a radioactive substance and given~     with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer~     cells and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in~     this study, along with Velcade.~   "
119080|NCT01497262|"~     This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5~     mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional~     data in Multiple Sclerosis (MS) patient population that closely resembles the clinical~     population seen in routine medical care.~   "
119081|NCT01497249|"~     The objective of this study is to provide evidence for its fermentability of a dietary fiber~     and to collect information regarding potential health opportunities for glucose control as~     well as tolerability when being consumed over 7 days.~   "
119082|NCT01497236|"~     The purpose of this study is to determine whether 14 days nutritional supplementation with~     Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection~     will prevent malnutrition and reduce the frequency of morbidity.~   "
119083|NCT01497223|"~     The primary objective of the study is to evaluate the rate of therapeutic cure of the~     combination treatment of MGCD290 and fluconazole as compared to that of fluconazole alone at~     Test of Cure Visit for patients with moderate to severe vulvovaginal candidiasis.~   "
119086|NCT01497184|"~     The goal of this clinical research study is to learn if researchers can successfully and~     safely give HSCT patients an infusion of white blood cells (called T-cells) that have been~     genetically changed. The process of changing the DNA (the genetic material in cells) of~     these T-cells is called gene transfer. Researchers want to learn if these~     genetically-changed T-cells are effective in attacking cancer cells in patients with~     advanced B-cell lymphoma or leukemia, after they have received standard allogeneic HSCT.~     Researchers want to find out the highest dose of these special T-cells that can be given~     safely to leukemia and lymphoma patients. Researchers also want to learn how long the~     changed T-cells stay in your body, and if adding them to standard transplant can improve how~     you respond to treatment.~   "
119087|NCT01497171|"~     This study is designed to compare the safety and efficacy of a commercially available mesh~     kit used for surgical repair of anterior vaginal wall prolapse with traditional suture~     repair surgery.~   "
119088|NCT01497158|"~     This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with~     a novel approach of adoption of home smoking restrictions. This will be done by providing~     the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS.~     The intent is to identify an intervention strategy(ies) to reduce ETS exposure.~   "
119089|NCT01497145|"~     This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to~     Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects~     with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.~   "
119090|NCT01497132|"~     The purpose of this study is to evaluate if treatment with vitamin D increase beta cell~     function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes~     mellitus type 2.~   "
119091|NCT01497119|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.~   "
119092|NCT01497106|"~     This study is being done to understand the effects of calorie restriction and weight loss on~     muscle protein metabolism in adult men and women.~   "
119093|NCT01497093|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of pomalidomide~     in combination with bortezomib and low-dose dexamethasone in subjects with relapsed or~     refractory multiple myeloma~   "
119094|NCT01497080|"~     The Problem Distal radius fractures (DRF) are common and result in a variable amount of~     disability. The investigators have completed considerable work in developing tools that~     measure impairment and disability after DRF . The investigators initial studies indicate~     that the associated disablement process is multifactorial and variable with only 25% of the~     resultant disability predicted by baseline patient and injury characteristics. The~     investigators see DRF as a signal event where some people are at-risk of transitioning from~     an active lifestyle to inactivity and subsequent health risks. The investigators recent data~     confirms variable participation following a DRF. The traditional focus in~     orthopedic/rehabilitative approaches to DRF fracture management has been localized to the~     wrist, largely ignoring this potential transition and its health impacts. The investigators~     will initiate a line of investigation that will profile the at-risk older adult who presents~     with a DRF with the ultimate goal of accurate identification and prevention of adverse~     activity transitions (active to inactive). In this study the investigators will identify the~     extent of the problem by quantifying changes in activity/participation and its short-term~     health impacts. The investigators will also identify the risk factors present at time of~     injury that predict a loss of mobility/activity/participation. This work has the potential~     to identify tools and/or clinical prediction rules that identify at-risk individuals at a~     critical time where early intervention might most easily prevent adverse outcomes associated~     with inactivity.~   "
119095|NCT01497054|"~     The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be~     used to predict a hemodynamically significant patent ductus arteriosus (PDA). This peptide~     is produced by the ventricles in the heart when they are under stress, such as when a ductus~     remains open. If we can use a simple and inexpensive blood test to determine whether a PDA~     needs to be treated, we can potentially treat infants sooner than if they needed to wait for~     the availability of a cardiologist to perform an echocardiogram. This might decrease some of~     the deleterious effects of PDAs on the preterm infant such as bronchopulmonary dysplasia,~     necrotizing enterocolitis, renal hypoperfusion, and pulmonary hemorrhage. In a situation~     where follow up echocardiogram after a course of medical therapy shows persistent PDA, this~     test may help to decide whether this baby needs further treatment, either medical or~     surgical.~   "
119096|NCT01497041|"~     1. Goals~           The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin~          in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC)~          as second-line treatment~           Secondary goals are to:~           evaluate the treatment-related toxicities of this combination, investigate~          progression-free survival (PFS) and overall survival (OS) in this population~        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase~          II trial according to the two stage testing design by Simon two-stage testing procedure~   "
119097|NCT01497028|"~     This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable~     Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in~     bariatric surgical outcomes~        -  Weight Loss~        -  Co-morbid disease resolution~   "
119098|NCT01497015|"~     This is a randomized controlled trial to evaluate the ACTIVE memory training intervention~     and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific~     aims and hypotheses are:~      Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among~     Breast Cancer Survivors (BCS).~      Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as~     more acceptable and useful than BCS assigned to the attention control condition.~      Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to~     the attention control and no-contact control conditions.~      Hypothesis 2: Memory training will result in greater memory enhancement immediately post and~     2-months post-intervention relative to attention control or no-contact control conditions.~   "
119099|NCT01497002|"~     Improvement of the treatment-results in elderly patients with acute myeloid leukemia through~     intensification of consolidation chemotherapy and/or allografting as consolidative~     immunotherapy~   "
119101|NCT01496976|"~     The main purpose of this study is to see if ofatumumab with methylprednisolone followed by~     additional treatment with ofatumumab and lenalidomide can help people with Chronic~     Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also~     want to find out if the combination of ofatumumab with methylprednisolone followed by~     additional treatment with ofatumumab and lenalidomide is safe and tolerable.~   "
119102|NCT01496963|"~     This is a multicenter observational case-control analysis lasting 12 months aimed at~     determining the prevalence of pulmonary hypertension (PAH) in patients with Thalassemia~     Major and Intermedia. The patients will be followed, treated and examined according to the~     best standard clinical practice dictated by the Italian Society for the study of~     Hemoglobinopathies (SITE), Thalassemia International Federation (TIF)and the Task Force for~     Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC);~     European Respiratory Society (ERS); International Society of Heart and Lung Transplantation~     (ISHLT) guidelines.~   "
119103|NCT01496950|"~     The purpose of this study is to determine whether active repetitive transcranial magnetic~     stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive~     treatment of chronic migraine, compared to placebo repetitive transcranial magnetic~     stimulation.~   "
119104|NCT01496937|"~     The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974~     present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy~     subjects.~      Furthermore, during the course of the study, safety and tolerability as well as the effects~     of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will~     be characterized compared to placebo.~   "
119105|NCT01496924|"~     There is an association between increased risk of oropharyngeal dysphagia and artificial~     ventilation through endotracheal tube, followed by tracheostomy. The aim of the present~     study is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic~     tracheostomized patients under mechanical ventilation at the intensive care unit.~   "
119106|NCT01496911|"~     Antihistamines are commonly used and currently levocetirizine is most frequently prescribed~     in the Netherlands. They are commonly used by divers, to solve ear, nose and throat~     problems, especially to open tubal passage. However, the effects of these drugs on cognitive~     performance have not been investigated during diving.The objective of this study is to~     investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and~     psychomotor functioning during controlled simulated diving in a hyperbaric chamber in~     professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that~     hydroxyzine will produce significant impairment, and that the magnitude of impairment is~     related to hyperbaric pressure.~   "
119107|NCT01496898|"~     The goal of this study is to examine changes in the bacterial ecology and inflammatory~     markers of the female genital tract with levonorgestrel intrauterine device placement.~      The specific research objectives of this project include:~        1. Characterization of vaginal, cervical and uterine bacterial species and communities~          prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples~          will be collected up to 1 week before and 2 months after IUD insertion.~        2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to~          and after LNG IUD placement using human RNA microarray analysis. Samples will be~          analyzed from up to one day before and three weeks after IUD insertion.~        3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.~   "
119108|NCT01496885|"~     The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to~     assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.~   "
119109|NCT01496872|"~     Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in~     newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction~     involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial~     somatic dysfunction. This observational study is intended to continue their work in~     exploring the presence of cranial somatic dysfunction in newborns. The hypothesis is that~     there is an increased incidence of somatic dysfunction in newborns birthed by primigravid~     women and in newborns who experienced a longer second stage of labor.~   "
119110|NCT01496859|"~     The Baska mask is a new supraglottic airway device . The investigators would like to assess~     its performance in setting in which the current standard - LMA device - is being used.~   "
119111|NCT01496846|"~     The purpose of this study is to study the ability of a frequently used dental anesthetic~     (articaine) to achieve complete numbness of a diseased tooth with the most commonly used~     injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this~     technique fails, a commonly used supplemental technique with one of two possible dental~     anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of~     complete numbness between the two anesthetics.~      The investigators hypothesize that supplemental infiltration anesthesia with articaine will~     give the same success rate as lidocaine in achieving complete pulpal anesthesia in~     mandibular molars with irreversible pulpits.~      This study consisted of two periods of patient enrollment, treatment and data collection:~     Part I: 101 subjects; Part II: 100 subjects.~   "
119112|NCT01496833|"~     The purpose of this study is to investigate the short to mid term efficacy and safety of a~     newly-developed branched stent graft in patients who had complex aortic lesions, such as~     ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde~     Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.~   "
119113|NCT01496820|"~     The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic~     effects of high molecular weight chitosan are related to diabetic models with~     hypoinsulinemia but have shown little effect on the blood glucose levels in hyperinsulinemia~     related diabetic models. Based on previous reports, high molecular weight chitosan either~     directly or indirectly related to insulin secretion in pancreas but has little effect on~     insulin resistance. In the present study, the effect of GO2KA1 (low molecular weight~     chitosan oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be~     evaluated. The changes in postprandial blood glucose levels will be investigated in subjects~     with impaired fasting glucose or glucose tolerance.~   "
119133|NCT01496560|"~     The aim of the study is to determine what precolonoscopic measures can be correlated to pain~     during colonoscopy~   "
119114|NCT01496807|"~     The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when~     it is given to people who are also receiving a drug called Sylatron. Investigators also wish~     to find out whether the addition of Yervoy increases the chance that Sylatron will cause a~     rise in the level of antibodies in the patient's blood that recognize their own tissues,~     known as autoimmune antibodies. Investigators also want to find out how likely it is that~     their tumor will shrink.~   "
119115|NCT01496794|"~     The intent of this surveillance study will be to obtain written permission from patients~     with bacterial endophthalmitis in order to compare sterilization rates of their cultured~     bacterial isolates to standard therapy (vancomycin and ceftazidime) versus combination~     therapy with vancomycin, ceftazidime, and moxifloxacin.~      Research hypothesis:~        1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with~          combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to standard~          therapy with vancomycin and ceftazidime.~        2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing~          rates of multi-antibiotic resistance.~   "
119116|NCT01496781|"~     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment~     techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common~     complication following EMR. Several endoscopic hemostasis methods are currently in use~     including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new~     hemostasis material was previously used for surgical hemostasis, but the therapeutic effect~     and safety in endoscopic application remains unknown. This randomized controlled study has~     been designed to compare PAPH with metallic hemoclip in their hemostatic effect of~     intra-procedure bleeding control and rebleeding prevention during and after EMR.~   "
119117|NCT01496768|"~     This study aims to evaluate the effects of chronic leucine supplemetion on glucose~     homeostasis, body compositin, muscle mass and strength of healthy and young subjects~   "
119118|NCT01496755|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and~     pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to~     receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on~     study treatment is up to 57 days with a 12-week follow-up.~   "
119119|NCT01496742|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone~     chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV~     non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive~     4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum~     (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day~     cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum~     (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day~     cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy~     with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or~     pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is~     until disease progression or unacceptable toxicity occurs.~   "
119120|NCT01496729|"~     Postoperative pain is a major problem in patients who either donate a kidney or undergo~     kidney transplantation. This pain is commonly treated with opioids, which can cause several~     side effects, ranging from pruritus, impaired vigilance, and most concerning to severe~     respiratory depression. This can be aggravated in the recipient by accumulation of opioid~     metabolites secondary to renal impairment and secretion.~      Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP)~     block after surgery in the lower abdomen. In the proposed study, we plan to compare the~     impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a~     ultrasound guided sham block with normal saline (placebo) on postoperative pain scores,~     postoperative opioid consumption, as well as patient's satisfaction.~      The investigators hypothesize, that patients who receive a TAP block will have lower~     postoperative pain scores, lower postoperative opioid consumption as well as higher~     satisfaction scores.~   "
119121|NCT01496716|"~     The purpose of this study is to investigate whether there is a correlation between hip~     arthroplasty patients' preoperative weight and the patients quality of life and the clinical~     effect one year postoperatively.~   "
119122|NCT01496703|"~     Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with~     improved graft survival in renal transplant recipients. However, MMF-related side effects~     often necessitate dose reduction which may expose transplant recipients to a higher risk of~     acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose~     reduction during the first year after kidney transplantation and its impact on acute~     rejection, overall and death-censored graft loss. Methods: Retrospective electronic file~     based analysis of all patients who underwent a single kidney transplantation in our center~     between 1996 and 2007 and were treated with MMF as part of their initial maintenance~     immunosuppressive protocol (n=749).~   "
119123|NCT01496690|"~     The PACS study aims to investigate the efficacy and tolerability of pregabalin for~     schizophrenic patients that suffer from comorbid anxiety.~      The study design is an 8 week flexible dosage, randomized placebo controlled.~      The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients~     are recruited from outpatient clinics from entire Denmark.~   "
119124|NCT01496677|"~     To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger~     control subjects~   "
119125|NCT01496664|"~     The purpose of the registry is to assess results of combined operative and catheter based~     (hybrid procedure) treatment of patients with significant coronary artery disease using~     essential clinical and angiographic parameters.~      Based on existing literature we expect the results of coronary artery bypass grafting of the~     anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary~     artery graft, to be superior to stent treatment of the same artery.~      At the same time a catheter based intervention using balloon, bare metal stents (BMS) or~     drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for~     other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left~     circumflex coronary artery (CX).~      Therefore, we expect a combination of the mentioned surgical and catheter based techniques~     to be a better treatment than bypass operation or catheter based intervention alone.~   "
119126|NCT01496651|"~     Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty~     in the Treatment of Unprotected Left Main Stenosis.~      In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome~     parameters in patients with unprotected left main (LMCA) disease, treated with coronary~     artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug~     eluting stents (DES).~      DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of~     death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate~     of death.~   "
119127|NCT01496638|"~     How should coronary artery stenoses with significant side branch be stented?~      A strategy of stenting both main vessel and side branch compared to a strategy of stenting~     the main vessel and only stenting the side branch if necessary.~      The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac~     death, non-procedure related myocardial infarction and re-revascularization with~     percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).~   "
119128|NCT01496625|"~     Background:~      - To understand diseases of the retina and the eye, information is needed about people with~     and without such diseases. Researchers want to study these people and follow them over time.~     They also want to study body tissues and blood to understand the nature of eye disease.~     Studying genes, cells, and tissues may help them understand why some people get eye problems~     and others do not, or why some people respond to treatment while others do not. Researchers~     want to collect physical samples and personal data to develop a National Eye Institute~     database.~      Objectives:~      - To collect health information and blood and tissue samples from people with and without~     eye diseases, to be used in research studies.~      Eligibility:~        -  Individuals of any age with different types of eye disease.~        -  Healthy volunteers with no history of eye disease.~      Design:~        -  Participants may be recruited from National Eye Institute studies or may be referred~          from other sources.~        -  Participants will be screened with a physical exam and medical history. They will also~          have a full eye exam. Questions will be asked about family medical history, especially~          about eye disease.~        -  Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and~          urine, may be collected as needed. Adult participants may also provide a skin sample.~        -  Tissue or fluid from eye collected as part of eye care or treatment may also be added~          to the database.~        -  No treatment will be provided as part of this study.~   "
119129|NCT01496612|"~     Background:~      - Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies~     suggest that buspirone might act on parts of the brain that can increase certain levels of~     brain activity. Increasing this brain activity may help decrease epileptic seizures that~     come from certain parts of the brain. Researchers want to see if buspirone can reduce~     seizure frequency in people with seizures who are already taking antiseizure medication.~      Objectives:~      - To test whether buspirone can reduce the frequency of seizures in people whose seizures~     seem to start from one part of the brain.~      Eligibility:~        -  Individuals between 18 and 65 years of age who have seizures coming from one or more~          places in the brain.~        -  Participants must have tried at least two different antiseizure medications. They must~          also have had at least three seizures during a 1-month observation period while on~          current medicines.~      Design:~        -  Participants will have a screening visit with a physical exam and medical history.~          Participants will complete mood and memory testing scales. Blood, urine, and saliva~          samples will be collected.~        -  Participants will have a magnetic resonance imaging scan to evaluate brain structures~          that relate to epilepsy. They will also have a positron emission tomography scan to~          look at parts of the brain that are affected by buspirone.~        -  Participants will start taking a study drug (either buspirone or placebo) twice daily.~          They will keep a calendar of seizures and record any side effects. Treatment will be~          monitored with clinic visits and blood samples.~        -  After 12 weeks on the study drug, participants will gradually stop taking either the~          placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.~        -  After 2 weeks, participants will start taking a study drug that is the opposite of the~          one they had before. They will keep a calendar of seizures and record any side effects.~          Treatment will be monitored with clinic visits and blood samples.~        -  After 12 weeks on the study drug, participants will gradually stop taking either the~          placebo or buspirone.~        -  Participants will have a final followup visit with additional blood tests, mood and~          memory testing scales and imaging studies.~   "
119130|NCT01496599|"~     Background:~      - Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the~     loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not~     fully understand why the brain cells that produce dopamine stop working or die in people~     with PD. This study will use different ways of imaging the brain and brain chemicals to look~     at PD. It will compare brain imaging in people who definitely have PD to people who might~     have PD and to people without signs of PD. It will provide more information how the brain in~     people with PD changes over time.~      Objectives:~      - To understand the changes that occur in the brains of people with Parkinson s disease.~      Eligibility:~        -  Individuals at least 18 years of age who have definite or possible Parkinson s disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have a screening visit with a physical exam and medical history.~          Blood and urine samples will be collected.~        -  Participants will visit the National Institutes of Health Clinical Center once a year~          for 9 years. There will be 10 total visits. Most visits will last 5 to 6 hours a day~          for 2 to 3 days. Some or all of the following tests will be performed at each visit:~        -  Transcranial sonography, which uses sound waves to take pictures of the brain.~        -  Magnetic resonance imaging to take pictures of the brain. Some of these tests will be~          done at rest. Others will require participants to perform an activity during the scan.~        -  Dopamine imaging studies to show how the brain uses the chemical dopamine.~        -  Magnetoencephaolgraphy to show brain activity.~        -  Electromyography to show muscle activity.~        -  Medication withdrawal for 12 hours overnight for people taking PD medications. This may~          be done before some scans. Participants who feel unwell when they stop taking~          medications will be allowed to start taking them again.~        -  Participants will continue with the followup visits until the end of the study.~   "
119131|NCT01496586|"~     Background:~      - Many service members have reported feeling tired, a loss of motivation, mood changes, and~     problems working with others after they have a concussion during deployment. These problems~     may lead to problems with their job and relationships. This study hopes to figure out what~     parts of the brain may be affected in people with these problems after a concussion.~      Objectives:~      - To learn more about the problems that may occur after service members have a concussion~     during deployment and return home.~      Eligibility:~        -  Service members or veterans between 18 and 40 years of age who have had a mild~          traumatic brain injury (concussion) in the past 6 months.~        -  Companions (at least 18 years of age) of the service members will also be included in~          this study. Companions will have interacted with the service member at least 1 hour a~          week since deployment.~      Design:~        -  Service members will have 1 week of tests at the National Institutes of Health Clinical~          Center. Companions will have 2 days of tests at the Center.~        -  Each day, service members will have 4 or 8 hours of tests. Tests will include a medical~          history and physical exam, neuropsychological tests and imaging studies. The tests will~          ask about fatigue, stress, mood, pain, daily activities, and family support. The~          imaging studies will measure brain function at rest and during activity.~        -  Companions will have a medical history and physical exam. They will also complete~          several questionnaires about themselves as well as the service member/veteran. The~          tests will ask about fatigue, stress, mood, pain, daily activities, and family support.~   "
119132|NCT01496573|"~     This research trial studies biomarkers in tumor tissue samples from younger patients with~     rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer~   "
119134|NCT01496547|"~     Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem~     cell transplantation. In our previous retrospective study, the overall survival is~     14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly~     standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested~     that the conventional transplantation approach may not be able to overcome the refractory~     disease. A new strategy to combined a low dose regimen following intensive chemotherapy for~     tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In~     this study, we focus on a new treatment strategy for particular refractory AML patients.~   "
119135|NCT01496534|"~     This is a phase Ib dose escalation study of dovitinib given in combination with either~     gemcitabine plus cisplatin or carboplatin in patients with advanced solid tumors. Patients~     with advanced solid tumors, for whom treatment with gemcitabine plus cisplatin or~     carboplatin would otherwise be warranted, will be enrolled. The dose of dovitinib will be~     escalated in successive cohorts using standard 3+3 dose escalation rules. Patients will~     continue treatment, in the absence of prohibitive toxicity, until disease progression. The~     study will define the recommended phase II dose of these combination regimens.~   "
119136|NCT01496521|"~     Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an~     antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and~     efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this~     double-blind, randomized controlled clinical trial. Research project is planned to recruit~     10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China,~     which has been known as a high incidence region of ESCC. All the participants receive~     endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained~     lesions (USLs). The location and size of each USL will be recorded followed by collecting~     biopsy samples from each USL. Participants with USL are randomly assigned to receive 100~     mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six~     months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be~     at six months and the second at 3 or 5 years later). The primary outcome measure was~     occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of~     the participants and adverse events.~   "
119137|NCT01496508|"~     Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks~     gestation; surfactant and mechanical ventilation have been the standard treatment. However,~     despite advances in neonatal respiratory care, a considerable number of preterm infants~     develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated~     with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment.~     High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique~     in the late 1970s. It was expected to result in less BPD and death as a primary model of~     ventilation compared to conventional ventilation (CV) in the treatment of RDS. However,~     there is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in~     preterm infants regarding the prevention of death, BPD, intraventricular hemorrhage, and~     periventricular leucomalacia in the short term. The purpose of this study was to compare the~     efficacy and safety of HFOV and CV in preterm infants with severe RDS.~   "
119138|NCT01496495|"~     This is a Phase 1 study during which patients with low or intermediate-1 risk~     myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug in order to achieve the highest dose of the study drug possible that will not cause~     unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1~     (Completed).~      In the second part of the study, patients will receive the best dose of study drug~     determined from the first part of the study and will be followed to see what side effects~     and effectiveness the study drug has, if any, in treating the cancer. Approximately 30~     patients from the US will be enrolled in Part 2 (Completed).~   "
119139|NCT01496482|"~     Purpose:~      To establish whether there is a correlation between dry eye symptoms, age and gender, a~     difference in symptom intensity in different times of the day, which test (Schirmer or TBUT)~     better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy~     to use hygrometer in everyday clinical setting, and finally whether there is statistically~     significant correlation between applied tests (TBUT, Schirmer and evaporimetry).~      Methods:~      Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms.~      Examination included structured case history (questionnaire), slit lamp examination with~     fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.~   "
119140|NCT01496469|"~     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared~     to placebo on lowering ambulatory 24-hour mean blood pressure of participants with~     hypertension and hyperuricemia (not associated with gout).~   "
119141|NCT01496456|"~     This study is investigating the efficacy of caries lesion infiltration therapy as compared~     to the current preventative approach for early caries lesions.~   "
119142|NCT01496443|"~     The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once~     daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus~     (T2DM).~   "
119143|NCT01496430|"~     The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as~     well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in~     stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control~     was inadequate on metformin alone.~   "
119144|NCT01496417|"~     This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney~     transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland~     Aggregate Pathology Index) score is a preimplantation donor scoring system which has five~     histopathological parameters that impact long-term kidney outcomes. Many kidney transplant~     recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations.~     Kidney function may be affected by anti-rejection medications known as calcineurin~     inhibitors (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney~     or episodes of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using~     belatacept therapy (BMS) instead, may be associated with improved kidney transplant~     outcomes.~   "
119145|NCT01496404|"~     The aim of this research project is to compare electrocautery to scalpel for laparotomy skin~     incisions, with the following objectives:~        1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.~        2. To compare the rates of wound infection with each technique.~        3. To determine if electrocautery results in less postoperative pain. Our null hypothesis~          is that electrocautery is equivalent to scalpel for creating skin incisions; with~          respect to wound cosmesis, wound infection rate, and post-operative pain.~   "
119146|NCT01496391|"~     Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a~     kidney imaging agent or tracer that lights-up inside your body when scanned, but over the~     years its use has declined. The most commonly used tracer is Technetium-99m labelled~     Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term~     shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the~     world. As a result of such shortages, there is a need to identify other types of tracers~     that can be used for imaging. [I-123]-OIH may be an alternative.~      The purpose of this study is to examine the diagnostic performance characteristics of~     [I-123]-OIH in comparison to [Tc-99m]-MAG3.~   "
119147|NCT01496378|"~     The purpose of this study is to evaluate the feasibility and efficacy of problem-solving~     skills training (PSST) to reduce distress and increase coping abilities among parents of~     youth with chronic pain. We hypothesize that parents will complete the PSST intervention and~     will find it to be an acceptable and satisfactory treatment. We also hypothesize that~     parents who receive PSST will have less distress and better coping skills than parents who~     receive standard care, and that children of parents who receive PSST will have better~     physical and emotional functioning than children of parents who receive standard care.~   "
119148|NCT01496365|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with~     DPN.~   "
119149|NCT01496352|"~     This is a randomized, double-blind, placebo controlled, safety, tolerability, and~     pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal~     surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.~   "
119150|NCT01496339|"~     The purpose of this study is to investigate whether the treatment of human menstrual~     blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and~     effective.~   "
119151|NCT01496326|"~     This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment~     of ibuprofen compared to the use of a placebo topical treatment.~      A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days~     Dosing twice daily (b.i.d.)~   "
119152|NCT01496313|"~     The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day~     or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It~     will also help the investigators understand the side effects of different doses in these~     patients.~   "
119153|NCT01496300|"~     This study was initiated to investigate the impact of the computer based image free~     navigation on the precision of the cup implantation. The implantation of the acetabular~     component (cup) is known to be a critical step in hip endoprosthetics. The cup position~     influences significantly the function, the absence of pain and the longevity of the~     artificial hip joint. The image free navigation system OrthoPilot is used to control the~     positioning of the cup during surgery.~   "
119154|NCT01496287|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS~     for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.~   "
119155|NCT01496274|"~     This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control~     and prevention of bleeding episodes in subjects who have previously received factor~     replacement therapy for hemophilia B.~   "
119156|NCT01496261|"~     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and~     separate combination of clopidogrel 75mg/aspirin 100mg.~   "
119157|NCT01496248|"~     The purpose of this study is to determine whether Korean Red Ginseng are effective in the~     treatment of the residual symptoms of depression as an adjuvant treatment.~   "
119158|NCT01496235|"~     Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular~     and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase~     nitric oxide production and is involved in controlling blood pressure.~   "
119159|NCT01496222|"~     This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is~     used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients,~     scheduled for general, vascular or urological surgery under general and/or regional~     anesthesia.~   "
119160|NCT01496209|"~     A double blinded and placebo-controlled, dose escalation, single-center safety and~     preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in~     subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document~     myocardial regeneration in patients with chronic scar.~   "
119161|NCT01496196|"~     Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that~     varies from blood-streaking of sputum to coughing up large amounts of pure blood.~      Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.~      The most common site of bleeding is the tracheobronchial tree, which can be affected by~     inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic~     carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial~     arteries, which originate either from aorta or from intercostal arteries, and are part of~     the high-pressure systemic circulation, are the source of bleeding in bronchitis or~     bronchiectasis or endo bronchial tumors.~   "
119162|NCT01496183|"~     The purpose of this study is to look at how a two-week use of a medication called Olanzapine~     might change appetite, physical activity, resting metabolic rate, body composition, and~     weight in healthy men.~   "
119163|NCT01496170|"~     This study will assess the safety and pharmacodynamics of three different doses of MK-8931,~     a ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).~   "
119761|NCT01488318|"~     This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in~     recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after~     cetuximab-containing therapy (please see attached schema).~      The primary endpoint 12-week PFS.~   "
119164|NCT01496157|"~     The objective of this study is to evaluate a radiolabeled urea-based small molecule~     inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC), as a PET imaging~     biomarker of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a~     well characterized histological marker of prostate cancer tumor aggressiveness but a~     quantitative non-invasive method for PSMA detection and monitoring is not currently~     available. Development of such an imaging biomarker would be useful to differentiate~     indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate~     risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate~     high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer~     imaging. The investigators propose to study patients initially diagnosed with~     biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging~     will be positively correlated with prostate cancer by prostatectomy tissue step-section~     analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to~     conventional imaging modalities (CT, bone scan) and biopsy results when available. In~     addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA~     and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue~     immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason~     score, clinical stage, Partin tables derived prediction of pathologic stage).~   "
119165|NCT01496144|"~     Background: Models have tried to explain the driving mechanisms behind chronic non specific~     low back pain (CNSLBP) in order to propose better appropriate conservative treatment.~     Altered responses at spinal and/or supraspinal level may affect the perception of pain and~     degree of disability of CNSLBP patients. Recent clinical recommendations still propose~     active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be~     limited by pain-related manifestations. Current evidences suggest manual therapy (MT)~     induces a short-term analgesic effect through neurophysiological mechanisms at peripheral,~     spinal and cortical levels. The aim of this study was first, to assess whether MT has an~     instant analgesic effect, and second, to compare the long-lasting effect on functional~     disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two~     CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups,~     received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n =~     22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight~     therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained~     by measuring pain intensity (Visual Analogue Scale) before and immediately after the first~     intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability~     Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined~     before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.~   "
119166|NCT01496131|"~     This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate~     cancer.~   "
119167|NCT01496118|"~     Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis.~     Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a~     pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with~     proteasome inhibitors. The combination should enhance the activity of both agents against~     myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and~     panobinostat will be determined. Assuming this combination is feasible, the Phase II portion~     will proceed using the doses determined in Phase I.~   "
119168|NCT01496105|"~     The purpose of this study is to determine whether the topical use of lidocaine spray 10% on~     the cervix is an effective way to reduce pain during IUCD insertion.~   "
119169|NCT01496092|"~     The overarching aim of this proposal is to examine the effects of usual protein diet~     supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis~     (PD). The investigators will achieve this goal through a randomized controlled trial of~     administration of usual protein diet plus KA versus usual protein diet alone in patients on~     peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study~     will provide potential avenues for improvement of metabolic profile of patients on PD and~     possibly improve long-term outcomes such as cardiovascular disease risk and death.~   "
119170|NCT01496079|"~     Study objectives are to compare~        -  influenza antibody levels in infant sera and maternal colostrum or breast milk at~          delivery, 2, and 6 months women who receive influenza immunization in early pregnancy,~          late pregnancy, or no influenza immunization during pregnancy and their infants~        -  immune response to infant influenza immunization in infant sera at 6 and 7 months in~          infants with and without preexisting influenza antibody.~      Study hypotheses are that infants born to pregnant women who receive influenza immunization~     in late pregnancy will have~        -  higher levels and a longer serum influenza antibody duration in sera (hemagglutination~          inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by~          enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early~          pregnancy or not immunized~        -  fewer infants with preexisting antibody will have protective influenza antibody levels~          after they are immunized against influenza at 6 and 7 months compared with those~          without preexisting influenza antibody~   "
119171|NCT01496053|"~     Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in~     patients with ulcerative colitis (UC) and Crohn`s disease (CD), experience clinical,~     biochemical and genetical improvement in their disease.~      A prospective randomised study comparing the mushroom extract with placebo.~   "
119172|NCT01496040|"~     The purpose of the study is to assess the safety and efficacy of the active substance~     rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset~     retinal degeneration associated with RPE65 mutation.~   "
119173|NCT01496027|"~     The aim of the study is to compare the values of cerebral tissue oxygenation measured~     simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.~   "
119174|NCT01496014|"~     The purpose of this study is to characterize the bacteria in the wound bioburden at the~     time of definitive wound coverage/closure of severe tibia fractures in both the military and~     civilian populations.~   "
119339|NCT01493817|"~     This research study is studying biomarkers in tissue samples from younger patients with~     Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how patients respond to treatment~   "
119175|NCT01496001|"~     The initial aesthetic and functional conditions are recorded with the help of the Breast~     Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the~     Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer~     software, allowing for comparison. Determination of the initial quality of life is measured~     with the European Organisation of Research and Treatment of Cancer - Quality of Life~     Questionnaire number C30-BR23 (EORTC QoL C30-BR23).~      Patients then undergo surgical treatment according to institutional protocols. Following~     conventional marking of the orientation of the specimen, it is measured by an analytical~     scale.~      Histological examination of the specimen will record the largest diameters, and parameters~     of the lymph nodes, according to the institutional protocol.~      On the 4th week following surgery, assuming that wound healing is completed, patients' data~     are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are~     gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic~     resonance imaging is performed to assess the volume of the contralateral breast.~      Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each~     quadrant, threshold value in the quadrants, above of which it is not advisable to perform~     conventional breast conserving surgery due to poor outcomes.~   "
119176|NCT01495988|"~     This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1)~     standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor~     cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood~     vessel formation and can stimulate the immune system. Previous clinical studies in melanoma~     have shown that bevacizumab may improve clinical benefit (progression free survival) if~     combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a~     role in resistance to BRAF inhibitors. This randomized study will ask whether the addition~     of bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates~     and clinical benefit. Patients may have received no therapy for advanced disease or up to 2~     prior therapies, excluding BRAF and MEK inhibitors.~   "
119177|NCT01495975|"~     The goal of this research is to evaluate the impact and feasibility of using web-based~     patient-provider communication and a remote glucose monitoring tool to improve~     post-hospitalization glycemic control and patient self-care. The investigators hypothesize~     that providing patients this web-based tool over a 4-week period after discharge to home~     will result in more effective glycemic control compared to usual care, and that patients~     with access to the tool kit will have a trend towards improved diabetes self-management~     and less diabetes-related distress.~   "
119178|NCT01495962|"~     Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and~     acute general surgery patients. The technique involves source control of sepsis and~     hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut~     short to allow for resuscitation in the ICU after the immediately life threatening pathology~     is treated. Planned re-exploration is then performed within 24-48 hours. It is at this~     procedure that the injuries are reconstructed. This technique, unfortunately, has several~     complications implicit with its use including wound infection, enterocutaneous fistula~     formation, and intra-abdominal abscess development.[1] Additionally, in patients whom~     primary fascial closure is not achieved, extensive abdominal wall reconstruction will be~     required in 6-12 months. The key for preventing these complications is definitive closure of~     the abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an~     open abdominal wound at dismissal [1,2] Proven methods for decreasing the rate of planned~     ventral hernia utilize tension in the midline to counter the effects of lateral abdominal~     muscular retraction.[3,4,5] Despite these improvements, however, the planned ventral hernia~     rate continues to be substantial.[2] Botulinum toxin a (BTX) is an FDA approved neuron~     modulating agent which has been used extensively in cosmetic, motor and pain disorders over~     the past 20 years [6,7]. The toxin blocks acetylcholine and pain modulator release~     (calcitonin gene related peptide and substance P) from the pre-synaptic cholinergic nerve~     terminal. The peptides are unable to bind at their motor end plate receptors through a~     process that cleaves proteins involved in the transport protein cascade. This results in~     flaccid paralysis and neuromodulation of the abdominal wall muscles resulting in reduced~     lateral tension and pain. Theoretically, this could increase the rates of primary fascial~     closure, improve pain sensation, decrease the rate of complications associated with open~     abdomens all while lowering the costs and need for future abdominal wall reconstruction.~   "
119179|NCT01495949|"~     During induction for cardiac surgery, patient hemodynamic stability is achieved by using~     anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate.~     Etomidate although has been used for a long time but its safety regarding cortisol synthesis~     suppression is still doubtful. This study measures the changes in cortisol levels during~     cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive~     agents (etomidate and thiopentone). Recording data also include hemodynamic changes during~     induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount~     of insulin usage, length of ICU and hospital saty.~   "
119180|NCT01495936|"~     Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated~     (breathing performed by a breathing machine) during anesthesia using a lung protective~     ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the~     anesthesiologist is able to ventilate only one lung by inserting a special breathing tube,~     allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial~     two interventions used to improve blood oxygen levels during one lung ventilation will be~     compared . The two interventions are:~        1. Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non~          breathing) lung and~        2. Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the~          ventilated (breathing) lung.~      CPAP is performed by applying a steady flow of oxygen to the non ventilated (non breathing)~     lung at a continuous gentle pressure of 5cmH20.~      To perform a Recruitment Maneuver (RM) the anesthesiologist inflates the ventilated~     (breathing) lung with oxygen, holding the breath for 25 seconds so all the lung is opened~     up. Immediately after the recruitment maneuver PEEP will be applied. PEEP is an action which~     also helps keep the lung open, maintaining the benefits achieved by the RM. It is performed~     by adjusting settings on the ventilator (breathing machine). The ventilator creates and~     applies a gentle pressure (5cmH20) to the ventilating lung at the end of each breath.~      The outcome measure will be the oxygen content in blood (PaO2), measured in mmHg, using~     blood sample analysis.~      The null hypothesis is that compared to CPAP, RM-PEEP does not significantly increase the~     oxygen content of blood during OLV when using a lung protective ventilation strategy.~   "
119239|NCT01495143|"~     Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery.~     Minimal invasive surgery is postulated to result in less muscle damage and better outcome.~     The aim of this study is to monitor metabolic changes of the paraspinal muscle and to~     evaluate paraspinal muscle damage during surgery using microdialysis (MD).~   "
119181|NCT01495923|"~     The purpose of this study is to determine whether pharmacotherapy or epidural steroid~     injections are a better treatment for lumbosacral radicular pain.~      142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be~     randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will~     be allocated to receive an epidural steroid injection (ESI; group I), with an equal number~     allocated to receive gabapentin (group II). Patients & evaluating physicians will be~     blinded. Follow-up will be through 3-months after treatment.~   "
119182|NCT01495910|"~     The purpose of this study is to determine the minimum dose of abiraterone acetate needed to~     decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid~     replacement for classic 21-hydroxylase deficiency.~   "
119183|NCT01495897|"~     Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive~     muscle contractions of opposite muscles that lead to abnormal twisting movements or odd~     postures. Essential tremor is a slowly progressive neurologic disorder characterized by the~     appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or~     essential tremor is not fully elucidated. Dystonia and essential tremor are associated with~     dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the~     cerebellum and cerebellar pathways has also been recently suggested.~      The investigators propose to study 30 patients having a primary dystonia (15 DYT11~     genetically documented), 15 patients having an essential tremor without deep brain~     stimulation and 15 patients having an essential tremor with deep brain stimulation.A group~     of 30 healthy volunteers will be recruited and tested according to the same modalities. They~     will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.~      Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before~     and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage~     change in the mean saccade amplitude between pre-test and post-test.~      Expected results:~        -  no or fewer alteration of the performance to the adaptation task in the Parkinson group~          than in the Essential Tremor group/ dystonia group.~        -  abnormal reactive saccade backward adaptation in the Dystonia group and Essential~          Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.~   "
119184|NCT01495884|"~     This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic~     breast cancer, following disease progression during, or after, treatment with trastuzumab~     and taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on~     the maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™,~     50-60 mg/m2 i.v q3 weeks).~      Within the Phase I part, doses are assigned at registration according to the dose escalation~     scheme.~      The dose for the Phase II part of the trial will be based on the MTD established in the~     Phase I part of the study.~      Clinical and laboratory parameters will be assessed to evaluate disease response and~     toxicity of study therapy. Safety assessments will be performed every 3 weeks for the first~     24 weeks. Efficacy assessments (radiological examination) will be performed on all patients~     every 8 weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be~     performed at weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments~     will be performed every 12 weeks and at the end of treatment (disease progression,~     unacceptable toxicity or patient withdraws consent).~   "
119185|NCT01495871|"~     Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It~     has been called the signature wound of the Iraq war because of its frequency among troops.~     TBI is associated with many chronic disabilities. Physical alterations include reduced~     exercise tolerance and profound muscle weakness, whereas psychological alterations include~     diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues~     rely upon circulating blood amino acids as precursors for metabolic functions. The~     investigators have shown that even one year after injury, plasma valine, an essential amino~     acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The~     investigators speculate that low plasma valine concentration contributes to chronic fatigue~     after TBI, since valine and tryptophan compete for the same transporter into the brain, and~     a low plasma valine concentration will allow more tryptophan to be transported. As a~     consequence, increased brain tryptophan will increase serotonin production, which may~     significantly contribute to the development of fatigue. Thus, the investigators will test if~     restoring valine concentration in persons with TBI may reduce fatigue perception and improve~     physical and neuropsychological function. Further, the investigators have previously shown~     that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no~     data are currently available in persons recovering from TBI. Thus,the investigators will~     also test if EAA and/or valine can improve muscle mass in patients with TBI.~   "
119186|NCT01495858|"~     The objective of the study is to evaluate the efficacy and safety of a single oral dose of~     naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with~     postsurgical dental pain and phase advanced sleep.~   "
119187|NCT01495845|"~     The purpose of this study is to determine the feasibility of pharmacogenomics testing in a~     community pharmacy using clopidogrel as an example. The investigators hypothesize that this~     testing is feasible in this setting.~   "
119188|NCT01495832|"~     The Canadian population, as is the case in most developed countries, is ageing and becoming~     increasingly overweight and/or obese. Both ageing and obesity are associated with reduced~     cognitive performance which can impact adversely on the ability to undertake daily~     activities and increases the risk of loss of independent living and reduced quality of life.~     The investigators predict that consumption of ½ cup of pulses per day for 12 weeks will~     improve cognitive function in older overweight/obese adults and thus decrease the rate of~     cognitive decline that occurs in this at-risk population.~   "
119240|NCT01495130|"~     This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors~     during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures,~     such as ultrasound, may help find prostate cancer and find out how far the disease has~     spread during surgery~   "
119241|NCT01495117|"~     The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone~     iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver,~     hepatobiliary, small or large bowel, stomach) is effective.~   "
119189|NCT01495819|"~     The proposed study will examine the threshold for nicotine self-administration (NSA) using~     five different nicotine doses in young adult male and female non-dependent smokers (light~     and intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that~     will enroll 195 individuals, targeting a total of 72 completers (36 male and 36 females). In~     each of the five experimental sessions, smokers will be randomly assigned to one of the five~     doses of nicotine (0.0125, 0.025, 0.05, 0.1 and 0.2 mg/70 kg). The highest dose, 0.2 mg/70~     kg, corresponds to nicotine delivered by about one or two puffs of a cigarette. At the~     beginning of each experimental session, smokers will sample the assigned both the nicotine~     dose for that experimental session, and the placebo (saline) dose, followed by the~     opportunity to choose between nicotine and placebo for a total of ten choices over a~     150-minute period. The main outcomes will be threshold dose (the minimum dose of nicotine~     that is self-administered more than placebo) and the slope of dose-response for nicotine~     self-administration (changes in nicotine self-administration per unit change in nicotine~     dose). We will also collect measures of nicotine intake (cotinine), nicotine clearance~     (3-hydroxycotinine (3-HC) / cotinine), and self-report drug effects~   "
119190|NCT01495806|"~     Background: Functional abdominal pain disorders (FAPD) are common in school-aged children;~     however, there is no reliable treatment.~      Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.~      Trial Setting: Department of Pediatrics, The Medical University of Warsaw.~      Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in~     which they will receive either glucomannan (10g) or placebo for 4 weeks.~   "
119191|NCT01495793|"~     This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple~     administrations of the rotigotine transdermal system. The study was conducted in adolescent~     subjects (13 to <18 years of age) with idiopathic Restless Legs Syndrome (RLS).~   "
119192|NCT01495780|"~     Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between~     doctor visits, using things like at-home breathing tests, electronic diaries to answer~     questionnaires, and other monitoring devices. The hypothesis of this study is that the~     health and quality of life of people with COPD who do RHM for one year will be better than~     people with COPD who do not do RHM. Subjects who are at least 40 years old, have been~     diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic~     bronchitis or emphysema, and are current or former smokers will be invited to participate.~     This study is paid for by eResearch Technology (eRT).~      Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will~     participate in RHM. RHM will involve daily monitoring at home using a few electronic~     devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity~     monitoring. Visits will include physical exam and medical history, ECG, questionnaires,~     breathing tests, and exercise tests.~   "
119193|NCT01495767|"~     Data about psychodynamics in uveitis patients are scare. A negative impact of disease is~     described not only in adult patients with active, but also with quiescent disease. During~     adolescence even less is known about psychodynamics although this is an especially sensible~     and challenging stage of life. Given the assumption that juvenile patients with quiescent~     disease still could suffer from emotional distress, this would require special attention.~      In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and~     attempted to identify clinical and demographic factors contributing to an impaired health~     status. The investigators limit the study to patients with quiescent uveitis and good visual~     function in at least one eye to exclude additional negative stressors. As there are no~     validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the~     investigators use age-appropriate generic instruments. This should allow obtaining an~     overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether~     psychological interventions should be offered to this sensitive patient group.~   "
119194|NCT01495754|"~     The purpose of the study is to investigate whether different doses of caffeinated coffee~     consumption has acute effects on subjective appetite feelings, energy intake and biochemical~     markers related to appetite, inflammation and glucose metabolism compared to water~     consumption in normal weight and overweight/obese participants.~   "
119195|NCT01495741|"~     This study will assess asenapine (Sycrest®) use in participants with bipolar disorder;~     comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine~     (Zyprexa®). The occurrence of identified and potential clinically important risks will also~     be assessed.~   "
119196|NCT01495728|"~     Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust~     manipulation will demonstrate immediate and short term significant clinically important~     changes in outcomes when compared to the sham manipulation group.~   "
119197|NCT01495715|"~     The objective of the study is to determine whether administration of idebenone can shorten~     the time to improvement of visual acuity in patients with chronic vision loss due to LHON.~   "
119198|NCT01495702|"~     This study will evaluate the noninferiority of Stribild®~     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF))~     single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse~     transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50~     copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will~     also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of~     treatment.~   "
119199|NCT01495689|"~     Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite~     quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are~     very lucky to have designed and developed the Ottawa Model for Smoking Cessation (Ottawa~     Model). This project is an end result of pain staking research. The Ottawa Model has been~     implemented very successfully to the hospitalized patients and has shown very promising~     results of higher quitting rates.~      Our objective is to modify the Ottawa Model to suit the needs of patients attending~     out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model~     along with the SmartCard to the adult smokers who attend the investigators out-patient~     Respirology clinic at the Ottawa Hospital.~      The investigators aim to train a nurse in clinical aspects and implementation of the~     protocols related to the Ottawa Model. The trained nurse will contact the smokers attending~     the clinic. Those subjects willing to participate in this study will be divided in to two~     groups. One group of subjects will get counseling and SmartCard on the day of the clinic and~     follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking~     medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem~     the card at the investigators hospital pharmacy. Those in the control group will be~     followed-up as the investigators are currently doing i.e. with standard smoking cessation~     counseling from the clinic physician and the nurse, +/- prescription for smoking cessation~     aids without access to the study nurse and the extra counseling or SmartCard. The~     investigators aim to find increased quitting rates in the group getting on-site access to~     the smoking cessation aids with the Smartcard and counseling.~      There are no studies implementing the Ottawa Model along with the SmartCard in out-patient~     respirology setting so far. The Ottawa Model has proven to be very successful in the~     in-patient subjects. Thus, the investigators believe, the investigators can modify the~     Ottawa Model and make it fit the out-patient Respirology setting and increase the quitting~     rates.~   "
119200|NCT01495676|"~     If radical cystectomy remains the standard of care for muscle invasive bladder cancer,~     consequences of this surgical procedure are often harsh. Over the past years, concurrent~     chemo-radiotherapy has imposed itself as an alternative treatment. Published data on~     concomitant radiochemotherapy (radiotherapy/cisplatin or~     radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder~     preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall~     survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and~     systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing~     effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer~     activities on urothelial diseases and has a synergetic activity with cisplatin. The~     investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and~     twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The~     objective of the present study is to evaluate the combination of radiotherapy + cisplatin +~     gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial~     cancer patients.~   "
119201|NCT01495663|"~     The purpose of this study is to determine the recommended dose of I-131-CLR1404, a~     radiolabeled therapy compound, for treating subjects with cancer that does not respond to~     treatment or has returned. The identified recommended dose in this study will be used as the~     optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase~     clinical development.~      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the~     study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase,~     subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on~     the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of~     biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated,~     the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects~     will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be~     in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable~     toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.~      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to~     injection of the dosimetric dose, and continuing for 14 days after the administration of the~     therapy dose.~   "
119202|NCT01495650|"~     Cancer-related fatigue is by far the most common symptom affecting cancer patients.~     Combining regular dietary counseling and tailored physical activity is associated with~     reduced cancer-related fatigue and can improve quality of life and body weight control. We~     propose to conduct a randomized controlled trial which purpose is to evaluate the effect of~     an intervention combining physical exercise and nutritional therapeutic education on~     cancer-related fatigue. To gain behavioral change towards PA and nutrition habits,~     interventions will take place within hospitals, on the same days of adjuvant treatments.~   "
119203|NCT01495637|"~     The GIFT study is a prospective, multi-center, interventional trial using the drug GM-CSF~     for the reversal of innate immune suppression in critically injured children. The study will~     be conducted in two phases, a dose-finding phase then an efficacy phase. The dose-finding~     phase is the current active phase of the study. The central hypothesis of the study is that~     immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection~     after critical injury in high-risk children through safe, rapid, and sustained improvement~     in innate immune function.~   "
119204|NCT01495624|"~     Patients undergoing rotator cuff repair or subacromial decompression at the investigators~     institution are frequently hospitalized overnight due to inadequate pain relief after~     resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators~     usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours~     without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of~     prolonging analgesia from a brachial plexus block without the extra equipment and logistical~     difficulties of indwelling catheters would benefit both patients and caregivers. A potential~     approach is use of adjuvant drugs that prolong block duration when added to the local~     anesthetic.~      In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate~     glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory,~     analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their~     effects by inhibition of phospholipase A2 as well as changes in cell function induced by~     glucocorticoid receptor activation. Although associated with significant toxicity when~     administered in large doses for long periods, emerging literature suggests that a single~     perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at~     the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging~     regional anesthetics. Available data thus suggest that combining glucocorticoids with local~     anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown~     to reduce postoperative pain. This raises the question whether the beneficial effects of~     adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated~     at least in part by systemic action. Previous trials, however, have not addressed this~     important issue. If this beneficial effect of analgesic duration is mediated by systemic~     action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no~     study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to~     confirm the safety of this route, achieving similar results with more conventional~     administration would be desirable for two reasons. First, conventional intravenous dosing is~     convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and~     well-studied. Second, equivalent (or not equivalent) results from systemic dosing would~     provide valuable information about the mechanism behind dexamethasone's effect on block~     duration.~   "
119205|NCT01495611|"~     The purpose of this research study is to identify factors and genes (the DNA material that~     determines the makeup of the human body) that may be associated with how children respond to~     pain medication. Specifically, the investigators want to study factors that may be~     associated with pain sensitivity, morphine requirement after surgery and side-effects from~     morphine and other pain medications. The investigators expect that the information obtained~     in this research study will help us to develop more effective, safe, and tailored treatment~     options in the future.~   "
119206|NCT01495598|"~     Background:~      - Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by~     mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote~     tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the~     growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide~     can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma~     may be associated with human immunodeficiency virus (HIV) infection, researchers want to~     test the drug in people with and without HIV infection.~      Objectives:~      - To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with~     or without HIV.~      Eligibility:~        -  Individuals at least 18 years of age who have Kaposi sarcoma.~        -  Participants may or may not have HIV infection.~      Design:~        -  Potential participants will be screened with a medical history and physical exam. Blood~          and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of~          a Kaposi sarcoma lesion may be performed if one has not already been done. Other~          imaging studies may be performed if needed.~        -  Participants will take pomalidomide capsules every day for 3 weeks, followed by a~          1-week break. These 28 days are one cycle of treatment.~        -  Participants will have up six cycles of treatment, unless the lesions completely~          resolve sooner. If there are signs of improvement after six cycles but the lesions are~          not completely gone, up to another six cycles of treatment may be given.~        -  Treatment will be monitored with frequent blood tests and other studies including~          photograph and other imaging of skin lesions.~        -  Participants will have regular follow-up visits for 5 years after stopping~          treatment....~   "
119207|NCT01495585|"~     Background:~        -  Chronic hepatitis D is a severe disease of the liver caused by infection with the~          hepatitis D virus. The hepatitis D virus can only infect a person who also has~          hepatitis B; therefore, people with delta hepatitis have both hepatitis B and hepatitis~          D virus infection. Most people with hepatitis D eventually develop cirrhosis, which~          causes scarring and damage to the liver. There is currently no effective treatment for~          chronic hepatitis D.~        -  Lonafarnib is a drug that was originally designed to treat different types of cancer.~          It may be able to prevent the hepatitis D virus from reproducing itself. However, it~          has not been tested on people with hepatitis D. Researchers want to study different~          doses of lonafarnib to see how they affect virus levels and other symptoms of hepatitis~          D.~      Objectives:~      - To test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D.~      Eligibility:~      - Individuals at least 18 years of age who have chronic hepatitis D.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests, eye exams, and imaging studies of the liver and gall bladder. A~          liver biopsy may also be performed.~        -  Participants will receive either lonafarnib or placebo twice a day for 28 days. For the~          first 3 days, participants will stay in the hospital to have frequent blood tests.~          Participants will have four more clinic visits (on days 7, 14, 21, and 28) for blood~          and urine tests. Eye exams and heart function tests will also be given. Men may be~          asked to provide sperm samples for further testing.~        -  After the 28 days of treatment, participants will stop taking the drug or placebo. They~          will have regular followup visits for up to 6 months after stopping treatment....~   "
119208|NCT01495572|"~     Background:~      - Some cancer treatments collect a patient s own blood cells to use as specialized~     cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood~     lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with~     PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can~     survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new~     cells grow. Researchers want to see if special white blood cells that recognize a specific~     protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART))~     can cause tumors to shrink. These white blood cells will be tested with and without~     aldesleukin.~      Objectives:~        -  To test the safety and effectiveness of white blood cells that target MART in the~          treatment of melanoma.~        -  To test white blood cells that target MART with and without aldesleukin.~      Eligibility:~      - Individuals at least 18 years of age who have melanoma that has not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. Blood and urine~          samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging~          scans will be performed.~        -  Participants will provide white blood cells through leukapheresis. Researchers will~          attempt to isolate white blood cells that recognize MART~        -  Seven days before the start of treatment, participants will have chemotherapy.~        -  After the last dose of chemotherapy, participants will receive the MART reactive PBL~          cells. Filgrastim doses will also be given to help white blood cell counts return to~          normal. Participants will have frequent blood tests.~        -  Participants who are able to have aldesleukin treatment will start within 24 hours~          after receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.~        -  Participants may have an optional tumor or lymph node biopsy to study the effects of~          treatment.~        -  If the tumor continues to grow after MART PBL treatment, participants may have one more~          round of cell collection and treatment.~        -  Participants will have followup visits for up to 6 months after receiving the MART~          reactive PBL treatment.~   "
119209|NCT01495546|"~     In Brazil, several hip surgeries performed, especially total knee arthroplasty, which~     represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these~     individuals is slow with respect to the march because it requires an aid and not to use the~     operated leg as support for three weeks, according to conventional methods. After the third~     week, the support becomes part and after that period (sixth week), the support becomes~     total. Therefore, and in order to provide better quality of life, the goal of this work is~     to compare the march in 40 patients divided into two groups of 20 subjects each. In the~     control group, the treatment approach is the traditional, i.e., without immediate loading,~     while the other charge will be applied immediately in the operated limb. In order to verify~     the possible gain in the quality of life of these patients, the SF-36 will be applied. The~     march will be assessed with the Time Up and Go test and the force platform and the Harris~     Hip score analyze the function of the hip. Individuals will receive such care at the~     Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine,~     University of São Paulo (IOT - HC - USP). The results of comparisons between the two groups~     and the clinical findings obtained will be subjected to appropriate statistical tests,~     guided by the principles of evidence-based clinical practice, seeking to facilitate and~     improve the lives of these individuals so they can move freely.~   "
119210|NCT01495533|"~     The purpose of this study is to examine the treatment of coronary Bare Metal Stent~     restenosis with a drug coated AngioSculpt scoring balloon.~   "
119211|NCT01495520|"~     Patients with ischemic heart disease often report multiple symptoms, including angina and~     palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's~     effect on multiple ion channels. It remains unknown, however, whether the favorable effects~     of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to~     test the hypothesis that chronic treatment with ranolazine can improve the symptomatic~     status of patients with ischemic heart disease by reducing the occurrence of palpitations.~   "
119212|NCT01495507|"~     The field of patellofemoral disorders and accordant therapeutical interventions is a high~     turnover research field. It is important to verify the clinical outcome with appropriate~     measuring tools. There is evidence that the Kujala score is a reliable and widely used~     measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used~     in many studies investigating patellofemoral disorders - also in german speaking patient~     groups. Unfortunately, we are not aware of a validated german version of the Kujala score.~     Other relevant knee outcome scores were already successfully translated into german language~     and validated by previous investigators.~      So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala~     score for use in German-speaking individuals with patellofemoral instability. It is~     hypothesized that the german version of the Kujala score shows:~        -  High divergent construct validity as determined by significant differences between~          patients and controls (hypothesis 1)~        -  High convergent construct validity as determined by significant correlations with other~          relevant scoring systems (hypothesis 2)~        -  High reliability (hypothesis 3)~        -  High responsiveness (hypothesis 4)~   "
119213|NCT01495494|"~     This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes.~     Prototypes were produced as an improvement to the currently marketed product.~   "
119214|NCT01495481|"~     The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the~     acute termination of Supraventricular Tachycardia (SVT).~   "
119215|NCT01495468|"~     This was a multicenter, randomized, open-label, parallel controlled phase III study,~     compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily~     administration formulation).~      All the subjects were randomized into two groups, test group (PEG somatorpin) and control~     group (Jintropin AQ), 200 children were enrolled in test group and 100 children were~     enrolled in control group. Considering the case loss during the clinical study, 20% of the~     patients were added in each of the group, that is 240 children were in test group and 120~     children were in control group, totally 360 children were enrolled in the phase III clinical~     study.~      Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point~     of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary~     time point was 3 month and 6 month after treatment, if the treatment was less than 6 months,~     the evaluation would be made when the treatment is finished.~   "
119216|NCT01495455|"~     Osteoarthritis is by far the most common joint condition and the single largest cause of~     disability in the older population. The investigators still have a poor understanding of the~     nature of osteoarthritis and factors that influence its development and progression.~     Identification of biochemical markers that relate to cartilage loss, bony overgrowth and~     other features that occur with osteoarthritis will advance our understanding. Over the last~     5 years analytical methods have developed to measure a range of different biomarkers. This~     pilot study will use these analytical methods to measure biomarker levels in joint fluid,~     urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.~      This study will provide novel pilot data on the changes in the composition of the synovial~     fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the~     knee is a suitable joint for study because of its accessibility to clinical assessment,~     joint aspiration and imaging.~   "
119217|NCT01495442|"~     The primary objective is to admix a radiolabel with albuterol sulphate for incorporation~     into the Handihaler® device for inhalation studies. This will allow for the investigators to~     determine the regional lung deposition of drug inhaled from the standard Handihaler® device~     compared to a novel modification of the device to provide more effective dispersion and~     aerosolization of the coated albuterol powder. The new mechanism of action for~     proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with~     drug powder, as opposed to the standard lactose formulation-filled capsule.~   "
119218|NCT01495429|"~     The investigators aim to compare the complications between centrally and peripherally~     inserted central venous catheters in neurological intensive care unit patients. The study~     hypothesis is that peripherally inserted catheters will have more cumulative complications~     due to venous thrombosis.~   "
119219|NCT01495403|"~     This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with~     patients having cramps due to their cirrhotic liver disease.~   "
119220|NCT01495390|"~     The purpose of this study is to collect biofluid samples for the banking and usage in ALS~     research. Through comparison of these samples, the researchers hope to learn more about the~     underlying cause of ALS, as well as find unique biological markers, which could be used to~     develop new therapies.~   "
119221|NCT01495377|"~     The purpose of this study is to determine weather remifentanil induced swallowing~     difficulties increase risk for pulmonary aspiration.~   "
119222|NCT01495364|"~     This study will assess the safety and efficacy of intracoronary artery administered~     autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial~     infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem~     cell treatment group to the control group in terms of the occurrence of AE's, SAE's and~     Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured~     quantitatively by gated single photon emission computed tomography myocardial perfusion~     imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac~     MRI in addition to other endpoints.~   "
119223|NCT01495351|"~     The combination of PARP inhibitor (ABT-888) with a proteasome inhibitors (bortezomib) have~     demonstrated significant anti-myeloma effects in preclinical lab and animal studies. The~     goal of this phase I trial is to evaluate in patients with relapsed or refractory multiple~     myeloma the safety, toxicity profile and tolerability of ABT-888 (Veliparib) administered on~     a schedule including twice daily oral dosing for 14 days followed by 1 week rest in~     combination with standard dosing of Bortezomib.~   "
119224|NCT01495338|"~     The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a~     placebo.~   "
119225|NCT01495325|"~     Exposure to air pollution is a well established risk factor for the development of heart~     disease. Firefighters are exposed to excess air pollution in the form of wood smoke during~     the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have~     been linked to specific duties and in particular fire suppression, but the reasons for this~     increase in risk are not well understood. Exposure to wood smoke may alter blood vessel~     function and increase blood clot formation to explain the link between fire suppression and~     heart attacks.~      The investigators wish to determine the effect of exposure to wood smoke at concentrations~     found at the perimeter of a woodland fire on blood vessel function and clotting in healthy~     non-smoking male professional firefighters or volunteers. Volunteers will be studied before~     and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body~     exposure chamber. The investigators will perform comprehensive vascular assessments~     thereafter.~      Understanding the effects of wood smoke on the blood vessels and clotting will be an~     important first step in helping to protect firefighters from heart disease. Through~     research, the investigators hope to identify methods to minimise the risk of heart attacks~     in firefighters and understand the health effects of a major source of air pollution that is~     relevant to the general population.~   "
119226|NCT01495312|"~     The purpose of this study is to determine the relationship between Intraocular Pressure~     (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens~     (SENSIMED Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty~     (SLT) for routine treatment of glaucoma.~   "
119227|NCT01495299|"~     The purpose of this study is to determine the relationship between intraocular pressure~     (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens~     (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This~     device has previously been investigated and shown to be safe and well tolerated.~   "
119242|NCT01495104|"~     This open-label, fixed-sequence, two-period study will assess the effect of multiple dose~     valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy~     male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout~     period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with~     concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.~   "
119243|NCT01495091|"~     The main purpose of this study is to examine whether changes in biomarkers during exercise~     are related to coronary artery disease demonstrated by coronary angiography or~     echocardiography.~   "
119244|NCT01495078|"~     The primary objective of the study is to determine the effect of automated daily~     selfreported symptom and weight, blood pressure and heart rate monitoring and clinical~     follow-up videoconference comigrate with clinical follow-up face in specialized hospital~     unit in reducing heart failure non-fatal events.~   "
119228|NCT01495286|"~     This research study represents a pilot, open arm study that will evaluate the safety of~     using Non−invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn~     infants less than 3 days of age who require heel sticks for clinical blood sampling. The~     investigators plan to enroll 51 infants into the study in order to obtain 42 completed~     infants. Two sub studies will precede the main safety study, with 6 infants in each sub~     study and 30 infants in the main study. These two sub studies will use electrical~     stimulation intensities that are a fraction of the planned intensity of electrical~     stimulation that will be used during the main part of the study.~      The clinical trial will be performed at the University of Arkansas for Medical Sciences~     Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick~     routinely used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks~     Electrical stimulation will be applied at appropriate acupuncture points using a very low~     current for 10 minutes, routine for procedural pain. The response to pain will be assessed~     using pain scales and physiologic changes.~      The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing~     a routine heelstick.~   "
119229|NCT01495273|"~     Various medical procedures require different objects to be inserted into the airway; for~     example, a bronchoscope - a fibreoptic camera device - can be guided down the windpipe to~     gain real-time images of the airway. Since inserting objects down the throat is~     uncomfortable for most patients, doctors have several options, one of which is putting the~     patient to sleep using general anesthetic before inserting something into the windpipe. This~     may not always be the best option, especially in cases where the patient needs to be awake~     during the procedure. In these cases, the doctor may 'freeze' the windpipe before inserting~     a scope or a tube into the airway. For this, the doctor inserts a needle through the front~     of the neck and injects local anesthetic. Inserting a needle into the windpipe comes with~     some risks to the patient, and the doctor wants to avoid puncturing nearby structures, such~     as arteries, veins, and the esophagus. The investigators have come up with a new method for~     accurately guiding a needle into the airway that will alert the user when they have~     successfully placed the needle tip in the windpipe. The investigators hypothesize that this~     new method will prove to be beneficial to clinicians and emergency medical personnel who~     need a fast, easy, and reliable way to insert a needle into the airway.~   "
119230|NCT01495260|"~     X-linked adrenoleukodystrophy is a rare, demyelinating and neurodegenerative disorder, due~     to a loss of function of a fatty acid transporter, the peroxisomal ABCD1protein. Its more~     frequent phenotype, the adrenomyeloneuropathy in adults, is characterized by axonal~     degeneration in spinal cord, spastic paraparesis and a disabling peripheral neuropathy.~     Actually, there is no efficient treatment for the disease. Our work in the last twelve years~     dissecting the physiopathological basis of the disorder has uncovered an involvement of the~     oxidative stress early in the neurodegenerative cascade. In a preclinical trial we have~     identified an antioxidant cocktail that efficiently reverse the clinical symptoms and the~     axonal degeneration in the mouse model for the disease. We propose the translation of the~     results to an open trial to test the tolerance and effectiveness of these drugs in the~     correction of the previously identified oxidative lesion biomarkers, as a first step to a~     randomized versus placebo, multicentric and international trial. You will be clinically~     explored and assessed in the Hospital Universitari of Bellvitge (HUB) using clinical scales~     for spasticity, disability, electroneurogram and cranial and spinal Nuclear Magnetic~     resonance (NMR). The information will be collected in a data base that will be of great~     value to improve the present attention and the future follow-up to facilitate your inclusion~     in therapeutic randomized, double blind, against placebo clinical trials.~   "
119231|NCT01495247|"~     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with~     patients that have locally advanced or metastatic HER2 negative breast cancer. The first~     part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the~     combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian~     model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will~     evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly~     paclitaxel plus BEZ235 bid.~   "
119232|NCT01495234|"~     This study is designed to generate data relating to patient safety, bone generating activity~     associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate~     the feasibility of conducting a larger clinical trial in a patient population requiring~     spinal fusion.~   "
119233|NCT01495221|"~     This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal~     aflibercept injection in patients who have been previously treated for AMD and have~     persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.~   "
119234|NCT01495208|"~     This is an open label study to evaluate the efficacy of intravitreal aflibercept injection~     2mg in patients with a persistent FVPED despite at least 6 consecutive injections with~     ranibizumab 0.5 mg.~   "
119235|NCT01495195|"~     No medications are currently available for treatment of psychostimulant addiction, a~     compulsive preoccupation with use of cocaine and related compounds. Donepezil is a~     medication that is currently prescribed for Alzheimer's disease, and selegiline is a~     medication used for treatment of Parkinson's Disease. Both of these medications can decrease~     the amount of cocaine injections that laboratory animals choose to inject by vein. This~     project will determine if combined treatment with donepezil and selegiline can also decrease~     cocaine-motivated behavior for human subjects in a laboratory setting.~   "
119236|NCT01495182|"~     The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber~     in healthy, adult volunteers.~   "
119237|NCT01495169|"~     Tolerability, undertstanding of the action of the drug in the body, and understanding the~     effect of the drug in adolescent patients needing treatment with an antipsychotic medication~   "
119238|NCT01495156|"~     The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial~     comparing two treatment strategies in adolescents with mania and prominent psychotic~     features. One group will receive a second generation antipsychotic (SGA) and placebo and the~     other will receive a SGA and lithium.~      The primary double-blind phase of the study will last 8 weeks, followed by a 24-week~     extension-phase.~   "
119772|NCT01488175|"~     The purpose of this study is to investigate if the use of a tourniquet during insertion of a~     cemented primary total knee arthroplasty will influence clinical and radiological (measured~     with RSA X-ray technique) outcome.~   "
119245|NCT01495065|"~     This is a two-part study. Part A is a three-period study in approximately 24 healthy male~     Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to~     investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous~     doses of GSK2251052. Period 3 is a single blind, placebo controlled, repeat fixed dose~     design to evaluate the safety, tolerability and pharmacokinetics of multiple intravenous~     doses of GSK2251052 for 12 days. The selection of the repeat IV dose will be based on the~     results from Periods 1 and 2. Japanese subjects will be stratified based on their metabolic~     genotype, polymorphic or wild-type for ADH and ALDH. Caucasian subjects are not anticipated~     to have these enzyme polymorphisms and therefore will not be stratified.~      Part B is a two cohort, single-blind, randomized, placebo-controlled, dose-rising, repeat~     dose study in approximately 24 healthy male and female subjects to evaluate the safety,~     tolerability, and pharmacokinetics of supratherapeutic IV doses of GSK2251052 for 10 days.~     Cohort 1 subjects will be randomized to receive 2250 mg of GSK2251052 or placebo and Cohort~     2 subjects will be randomized to receive 3000 mg GSK2251052 or placebo. The decision to~     conduct Cohort 2 of Part B will be based on the available toxicology cover results from~     ongoing preclinical toxicity studies.~   "
119246|NCT01495052|"~     Dietary modification is of great essential for the prevention and treatment of type 2~     diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential~     benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked~     oat (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of~     organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.~      After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel~     trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes.~     Participants would be randomly assigned to one of the four following groups: usual care~     group (only basic health advice, no other interventions), diet group (systematic education,~     structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus~     replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for~     years would be carried out to predict the long-term effects of ONOG plus diet intervention~     on patients with type 2 diabetes.~      The investigators hypothesized that ONOG combined with diet would have better effects on~     glycaemia and insulin resistance control in addition to those yielded by diet or usual care.~   "
119247|NCT01495039|"~     Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida~     colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is~     still a matter of debate.~      Methods. Randomized, single-center trial studying single drug (nystatin) versus control in~     surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU~     admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion~     was the time course of colonization index (CI) during ICU stay.~   "
119248|NCT01495026|"~     This study is an open-label, randomized, single dose, multi-stage, cross-over study in~     healthy male subjects of North East Asian ancestry. The aims are to:~        -  evaluate the pharmacokinetic parameters of several formulations of a fixed dose~          combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)~          relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin~          hydrochloride 0.2 mg tablets in the fasted state in order to define a formulation which~          is bioequivalent to a 0.2 mg orally disintegrating tamsulosin tablet, (Harnal-D~          Tablets)~        -  determine the effect of food on the relative bioavailability of tamsulosin in the FDC~          product which is assessed to be bioequivalent to Harnal-D Tablets in the fasted state~        -  assess the effect of water on the relative bioavailability of tamsulosin in Harnal-D~          Tablets in the fasted state~        -  assess the safety and tolerability of dosing with the different FDC capsule~          formulations Subjects will receive single oral doses in at least one treatment period;~          treatment periods will be separated by a 5-10 day washout period. Blood samples for~          pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will~          be assessed by measurement of blood pressure, heart rate and review of adverse events.~          Each stage of the study will enrol 18 subjects to ensure 16 complete. Subjects may~          consent to participate in more than one stage.~   "
119249|NCT01495013|"~     The aim of this 20 week study is to show that glimepiride/atorvastatin fixed dose~     combination tablet is safe and as effective as atorvastatin + glimepiride combination taken~     as separate tablets, in improving glycaemic control (glycated haemoglobin, HbA1c) and~     cholesterol levels (Low-density lipoprotein, LDL) in diabetic subjects, who are inadequately~     controlled on a stable dose of metformin. Eight dose combinations will be included.~   "
119250|NCT01495000|"~     The purpose of this study is to determine if denosumab is effective in increasing bone~     mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.~   "
119251|NCT01494987|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study~     to determine the effect of ranolazine when added to glimepiride on glycemic control in~     adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current~     treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.~   "
119252|NCT01494974|"~     The purpose of this study is to compare the success rates and complications of two models of~     Ahmed glaucoma implants (FP7 and FP8) in patients with pediatric glaucoma.~   "
119253|NCT01494961|"~     ANRS 12127 Prenahtest is an intervention trial conducted in four countries (Cameroon,~     Dominican Republic, Georgia and India), where pregnant women are randomized during prenatal~     care to receive either standard post-test HIV counseling, or an innovative intervention~     called couple-oriented post-test HIV counseling (COC).~      The aim of the COC intervention is to empower women to communicate with her male partner~     about HIV, and HIV testing in particular, and encourage him to return for HIV testing and/or~     couple HIV counseling (where both couple members are counseled together).~      Prenahtest is the first randomised trial testing a prenatal intervention to increase partner~     HIV testing.~   "
119254|NCT01494948|"~     The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is~     associated with the presence or development of allergic disease.~   "
119350|NCT01493674|"~     The aim of this study was to determine the effect of folic acid supplementation on~     homocysteine levels in a group of patients with eating disorders (ED) with low folate~     intake. The secondary aims were to evaluate the evolution on cognitive and depressive status~     after the intervention.~   "
119255|NCT01494935|"~     The investigators will determine whether people with high muscle mitochondrial capacity~     produce higher amount of reactive oxygen species (ROS) on consuming high fat /high glycemic~     diet and thus exhibit elevated cellular oxidative damage. The investigators previously found~     that Asian Indian immigrants have high mitochondrial capacity in spite of severe insulin~     resistance. Somalians are another new immigrant population with rapidly increasing~     prevalence of diabetes. Both of these groups traditionally consume low caloric density~     diets, and the investigators hypothesize that when these groups are exposed to high-calorie~     Western diets, they exhibit increased oxidative stress, oxidative damage, and insulin~     resistance. The investigators will compare Somalians and NE Americans who are matched for~     age, BMI, and sex. The investigators will measure ROS production in skeletal muscle~     following high fat/high glycemic diet vs. healthy diet. The investigators will compare the~     oxidative damage to proteins, DNA, and lipids in these two populations following 10 days of~     high fat/high glycemic index diet in comparison with low fat diet. The investigators will~     determine if elevated levels of oxidative damage in Somali immigrant populations is~     accompanied by high mitochondrial capacity, higher ROS-emitting potential, and lower insulin~     sensitivity than NE. The proposed study will be performed utilizing the state-of-the-art~     proteomic and metabolomic methods many of which were recently developed in our laboratory.~     The investigators expect the results from this study to provide seminal insights into the~     underlying mechanism of insulin resistance and type 2 diabetes, in addition to demonstrating~     mechanisms by which a functional proteome is maintained in vivo.~   "
119256|NCT01494922|"~     The purpose of this study is to provide subjects who participated in prior studies of EXC~     001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC~     001.~   "
119257|NCT01494909|"~     Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An~     impaired intestinal digestion and absorption capacity is one of the main factors responsible~     for the malnutrition in CF. This impairment starts early in life, leading to malnutrition,~     muscle weakness, impaired immune and lung function associated with poor prognosis. As low~     BMI and body weight is strongly associated with morbidity and mortality, a reduction in~     weight loss in CF and its manifestations would save the healthcare system substantially per~     year. Simple methods to measure the digested portions and utilization of nutrients and the~     effectiveness of pancreatic enzyme preparations and medications in CF are not available.~     Developing a panel of methods to accurately measure gut digestion, absorption and function~     will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement~     therapy in CF. Furthermore, it will provide detailed insight in the disease and age related~     mechanisms of gut dysfunction in CF. Finally, it will provide required information that will~     lead to implement new strategies to improve gut health in order to enhance nutritional~     status, quality of life and survival.~      The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can~     be quantified by an innovative panel of methods using stable isotopes. With this panel of~     methods, information can be obtained on the effect of disease progression on lipid, protein~     and glucose digestion and absorption and on gut function in CF as well as in other diseases~     and conditions characterized by a compromised gut. Furthermore, the optimal nutritional~     regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In~     the present study the investigators will study: 1. Pediatric patients with CF at Arkansas~     Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical~     Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic~     criteria. All CF patients are characterized by abnormal lipid digestion based on clinical~     and or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and~     requiring pancreatic enzyme replacement therapy, and no presence of unstable metabolic~     diseases. Additional criteria for the CF pediatric inpatients are: admitted to ACH for~     treatment of exacerbations of CF disease, clinically stable. The CF outpatients are stable~     outpatients with pancreatic insufficiency.~   "
119258|NCT01494896|"~     The purpose of this study is to see how inhaled treprostinil sodium (Tyvaso) affects the~     amount of air and blood that reach the alveoli, or tiy air sacs, in the lungs of patients~     with Group 1 Pulmonary Arterial Hypertension with concomitant Chronic Obstructive Pulmonary~     Disease (COPD).~   "
119259|NCT01494883|"~     The aim of the current study is to examine the (cost)effectiveness of mindfulness based~     stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer~     and their partners.~   "
119260|NCT01494870|"~     The primary objective of this study is to propose new treatment algorithm (strategy) for~     patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).~   "
119261|NCT01494857|"~     The purpose of this study is to assess the clinical benefit and tolerability of adalimumab,~     a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with~     ulcerative colitis (UC) naive to treatment with biologics.~   "
119262|NCT01494844|"~     This research study will test the comfort of two noninvasive respiratory monitoring sensors~     (the connection to a monitor worn by a person—not the monitor). The two sensors, Masimo~     Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by~     the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting.~     People who enter into the study will wear the two interfaces, one after the other, for 20~     minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without)~     and rate the comfort of each with a seven question survey. A total of 30 participants will~     be recruited.~   "
119263|NCT01494831|"~     The purpose of this study is to evaluate, in a randomised control trial (RCT), the~     effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in~     reducing psychological distress in former child soldiers and other war-affected children in~     the Democratic Republic of Congo (DRC).~   "
119264|NCT01494818|"~     The purpose of this study was to assess and compare the effect of the repeated usage of two~     different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting~     system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with~     silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific~     aspect of interest was the effect on the ocular tissue, in particular the eyelids and their~     associations with the contact lens surface wettability and surface contamination.~   "
119265|NCT01494805|"~     The study will involve approximately 40 subjects aged 55 or above who have exudative~     age-related macular degeneration (wet AMD). Patients will be randomized to receive one of~     two doses of rAAV.sFlt-1 or assigned to the control group.~   "
119266|NCT01494792|"~     The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and~     Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of~     Group A Streptococcus when compared to culture.~   "
119267|NCT01494779|"~     The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic~     effect between two preparations of somatropin (T and C) after a single administration of 5~     mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h,~     AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1~     presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).~   "
119268|NCT01494766|"~     Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter,~     dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is~     subsequently and avidly converted into dopamine. It is well known that dopamine deficiency~     leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine~     agonists and L-dopa to be effective in controlling symptoms. No studies to date have been~     done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine~     the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in~     treating RLS in addition to adding another possible agent to the investigators arsenal of~     treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will~     be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated,~     in increments of 750 mg every week in patients who meet the inclusion criteria for RLS.~     Patients' symptoms will be monitored on a weekly basis for six weeks.~   "
119269|NCT01494753|"~     The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345~     versus an active comparator.~   "
119270|NCT01494740|"~     The aim of this study is to investigate the immunogenicity and safety of the inactivated~     split-virion vaccine in infants.~   "
119271|NCT01494727|"~     The objectives of this study are:~        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge~          10/160mg after a single oral administration in healthy male volunteers~        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis~          Exforge 10/160mg after a single oral administration in healthy male volunteers~   "
119272|NCT01494714|"~     The purpose of this study is to evaluate skin irritation and photo irritation of JNJ~     10229570-AAA on intact skin of Japanese healthy male participants.~   "
119273|NCT01494701|"~     This study will test the safety, tolerability, and pharmacokinetics of escalating doses of~     ISIS-SMNRx administered into the spinal fluid as a single injection in patients with Spinal~     Muscular Atrophy.~   "
119274|NCT01494688|"~     This open-label, multicenter, dose-escalation study will assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid~     tumors which are not amenable to standard treatment. In Part I (Dose Escalation), multiple~     ascending doses of RO5509554 will be administered as monotherapy in participants with solid~     tumors. Participants with locally advanced and/or metastatic ovarian (including fallopian~     tube) and breast carcinoma will receive multiple ascending doses of RO5509554 in combination~     with paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as~     monotherapy to participants with locally advanced and/or metastatic Pigmented Villonodular~     Synovitis (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant~     mesothelioma, ovarian (including fallopian tube), endometrial or breast cancer and~     pancreatic cancer. Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu~     negative breast cancer will receive RO5509554 in combination with paclitaxel. Anticipated~     time on study treatment is until disease progression, unacceptable toxicity, death or~     participant refusal, whichever occurs first.~   "
119275|NCT01494675|"~     Recently, biomarkers like procalcitonin have been studied in order to help physicians to~     decrease the duration of the antibiotic therapy. The investigators objective was to assess~     whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy~     in critically ill patients with a proven infection without risking a worse outcome.~   "
119276|NCT01494662|"~     The purpose of this research study is to determine how well neratinib works in treating~     breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug~     that may stop breast cancer cells from growing abnormally by inhibiting (or blocking)~     members of a family of proteins that include Human Epidermal Growth Factor Receptor 2~     (HER2).~      In this research study, the investigators are looking to see how well neratinib works to~     decrease the size of or stabilize breast cancer that has spread to the brain. The~     investigators are also looking at how previous treatments have affected your thinking (or~     cognition) and how much neratinib reaches the central nervous system.~   "
119277|NCT01494649|"~     A pilot study to determine the ability of a stannous fluoride containing toothpaste to~     provide immediate and short term relief from dentine Hypersensitivity compared to a control~     toothpaste.~   "
119278|NCT01494636|"~     This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The~     study is split into two parts. Part A will assess the safety and tolerability of the new~     drug. Part B will assess safety and tolerability as well as the effect of GSK2339345 on~     induced cough.~   "
119279|NCT01494623|"~     Deficits in working memory (WM) performance are the most significant cognitive impairments~     in schizophrenia (SCZ). It has also been shown that WM performance is contingent on the~     cortex synchronization, a process that relies on brain inhibition. Repetitive Transcranial~     Magnetic Stimulation (rTMS) has been demonstrated as an effective treatment for patients~     with SCZ and has been shown to increase brain inhibition and improve cognitive performance.~     In this study the investigators intend to:~        -  evaluate rTMS as a treatment for WM deficits in SCZ~        -  evaluate rTMS as a method to increase WM performance in healthy individuals~        -  determine if improvements in WM performance are related to enhanced synchronization of~          brain networks~        -  determine whether genetic polymorphisms predict cortical function and treatment~          response~        -  evaluate the influence of rTMS treatment on brain structure.~   "
119295|NCT01494415|"~     Nab-paclitaxel and carboplatin showed better treatment response compared with~     cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell~     lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel,~     carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given~     nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced~     squamous cell lung cancer may have promising result.~   "
119296|NCT01494402|"~     The purpose of this study is to assess bioequivalence between D961S and~     esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and~     pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated~     administration in healthy male Japanese subjects.~   "
119361|NCT01493531|"~     This study will compare the serum uric acid lowering effects, clinical benefits, and safety~     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who~     have had an inadequate response to allopurinol.~   "
119280|NCT01494610|"~     This is a comparative bioavailability study to compare the pharmacokinetics and~     pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a~     capsule-based inhaler versus a multi-dose dry powder inhaler in patients with moderate~     asthma and in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).~      Co-primary endpoints will be the area under the curve (AUCτ) measured for plasma Fluticasone~     propionate (pharmacokinetic) and the pharmacodynamic effects of Fluticasone propionate~     (weighted mean serum cortisol over 0-12h) on the last day of each 10 day study treatment~     period. Secondary endpoints will include the following pharmacokinetic parameters for both~     fluticasone propionate and salmeterol: AUClast, AUC(0-t), Cmax, Cmin, tmax, λz, and t1/2 as~     well as the pharmacodynamic effects of salmeterol (pulse rate, blood pressure,~     electrocardiogram [ECG], potassium and glucose) and Fluticasone propionate (urine cortisol~     levels). Safety (adverse events and laboratory abnormalities) will also be assessed as a~     secondary endpoint.~      The study is a randomised, double blind, double dummy, four-period cross-over study.~     Approximately 60 asthma or COPD patients will be randomised. Patients meeting eligibility~     criteria will receive Fluticasone propionate/salmeterol 250/50mcg bid, from a capsule-based~     inhaler and from a multi-dose dry powder inhaler for a period of 10 days each in a~     randomised order. All patients will receive treatment from each device twice. To maintain~     the double blind, each patient will receive active treatment and placebo at the same time~     from two separate devices.~   "
119281|NCT01494597|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of cyclosporine in healthy adult subjects.~   "
119282|NCT01494584|"~     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of~     ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled~     partial onset seizures or Lennos-Gastaut syndrome.~   "
119283|NCT01494571|"~     The PharmaJet needle-free injection system is a consistent approach to delivering injectates~     into the dermal layer of the human skin for the purpose of vaccination or medication~     delivery.~   "
119284|NCT01494558|"~     Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the~     standard of care for patients with inoperable stage III NSCLC. The most common~     chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine,~     vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and~     carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the~     superiority of one chemotherapy regimen over another. The clinical trial is to compare~     radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and~     carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter,~     open labeled phase III clinical trial. All patients receive conformal radiotherapy or~     intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are~     PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC~     (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The~     primary purpose is to evaluate objective response rate, complications, progression-free~     survival, overall survival. The second purpose is to evaluate quality of life and cost.~   "
119285|NCT01494545|"~     The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time~     contact lens wearers.~   "
119286|NCT01494532|"~     This is a double blind, fixed dose, parallel group study to characterize the dose response~     of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's~     disease. The primary endpoint of this study, mean change from baseline in total awake time~     spent off' is the same endpoint as used in the ropinirole PR pivotal study for advanced~     Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg)~     with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total~     awake time spent off compared with placebo. The dose of Ldopa will remain stable through~     the study, unless the subject experiences tolerability issues that require an L-dopa dose~     reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to~     approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid~     confounding the efficacy data. Clinical review of the primary and secondary endpoints will~     be performed in order to establish the lowest maximally effective therapeutic dose.~   "
119287|NCT01494519|"~     The purpose of this study is to compare the use of modern ring external fixation versus~     internal fixation for fracture stabilization of severe open tibia fractures.~   "
119288|NCT01494506|"~     The study is an open label, randomized phase 3 study of MM-398 with or without~     5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and~     leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine~     based therapy.~   "
119289|NCT01494493|"~     The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone~     dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.~   "
119290|NCT01494480|"~     Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis~     due to the continued loss of motoneurons that leads them to death in less than 5 years. No~     treatment has changed its natural history. Intrathecal injection of umbilical cord~     mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The~     investigators have designed a phase I/II clinical trial to check the feasibility of this~     approach in humans.~   "
119291|NCT01494467|"~     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its~     vehicle when applied once daily, at bed time, during a 12 week period in subjects with~     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.~   "
119292|NCT01494454|"~     This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal~     System in treatment of the patients with degenerative disc disease.~   "
119293|NCT01494441|"~     The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and~     rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to~     instrumented fusion with autograft in patients with symptomatic degenerative disc disease.~   "
119294|NCT01494428|"~     The purpose of this pilot clinical trial is to evaluate the device design as a method of~     facilitating spinal fusion.~   "
119362|NCT01493518|"~     The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557~     following multiple subcutaneous dose administration in adults with moderate to severe~     psoriasis.~   "
119297|NCT01494389|"~     The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell~     immunity in the patients with sepsis.There are immunoparalysis in septic patients,the~     important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to~     the illness progress and outcome. Comprehend the change regularity of septic patients' cell~     immunity can guide fiter and correcter treatment.~   "
119298|NCT01494363|"~     1. Goals~           The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin,~          Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary~          tract cancer as first-line chemotherapy~           Secondary goals are to:~           evaluate the treatment-related toxicities of this combination, investigate~          progression-free survival(PFS) and overall survival(OS) in this population~        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase~          II trial according to the two stage testing design by Simon two-stage testing procedure~   "
119299|NCT01494350|"~     The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an~     open-label single site trial designed to expand our safety database and capture additional~     efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in~     Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects~     will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with~     at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial~     subjects will be consented and screened for eligibility including medical history, physical~     exam, lesion parasitology, and renal and liver function tests. If eligible for the study,~     subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n~     = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an~     investigator or study nurse. If a subject develops a new lesion during the study, the new~     lesion may also be treated with the topical cream.~   "
119300|NCT01494337|"~     The investigators are now proposing to compare two laser techniques for treating Benign~     prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus~     (greenlight) XPS which is a recently available technology in our center and is more~     efficient hence our choice to include patients with any size prostate. This will confirm~     whether the two techniques are equivalent in efficacy and safety independent of size as well~     as cost. The two techniques are available world wide as standard of care~   "
119301|NCT01494324|"~     The purpose of this study is to see if the investigators can do some tests on tissue from~     the area of the ablation. The investigators want to know if a test can help predict whether~     the ablation worked.~      The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in~     the area treated by ablation. However, cancer cells may begin to grow in or near the treated~     area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy~     liver cells that just look different because of the ablation. The test the investigators~     will study should be able to tell us the difference.~   "
119302|NCT01494311|"~     Arterial catheterization is painful and is associated with patient stress and anxiety.~     Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative~     is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing~     70 mg each of lidocaine and tetracaine. We therefore tested the hypothesis that Rapydan~     patch analgesia is non-inferior to subcutaneous local anesthetic.~   "
119303|NCT01494298|"~     Compared to other races, African-Americans with type 2 diabetes have different cholesterol~     levels, specifically triglycerides and low density lipoprotein. Recent data has shown the~     not only are cholesterol levels important in determining the risk for cardiovascular~     disease, but the size of the cholesterol particles and surface proteins on the cholesterol~     particles are also important. The objective of this study is to determine if~     African-American males with diabetes have different particle size, surface proteins, and~     cholesterol genetic links than African-American male without diabetes and Caucasian-American~     males with and without diabetes.~      African-American males with type 2 diabetes and not taking lipid-lowering medications are~     the current target population.~      After obtaining an informed consent, a complete medical history will be obtained and~     subjects will be examined, noninvasively, for physical signs of elevated cholesterol levels.~     Afterwards, blood samples [one venous puncture, 6 tubes (21 mL total)] will be obtained.~     Blood samples will be coded, sent to Berkeley Heart Lab and/or Clinical Laboratory Services,~     and undergo genetic testing at Mercer University College of Pharmacy and Health Sciences.~      Confidentiality of the subjects will be explained in the consenting process to the subjects.~     All subject samples and information will be coded. Each subject will be given a subject~     number upon consenting and this will be used throughout the study. All pertinent information~     of the subjects will be listed under the designated number, but will not be associated with~     that patient.~   "
119304|NCT01494285|"~     This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group,~     ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with~     mild to moderate acne vulgaris.~   "
119305|NCT01494272|"~     Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice.~     It has been shown to be effective in managing postoperative pain in children undergoing~     abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown~     that children receiving caudal blocks have secondary benefits such as lower narcotic and~     anesthetic requirements, more rapid awakening from general anesthesia, decreased time to~     discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias~     et al 1995, Tobias 1996).~      This proposed study involves the use of a caudal block in children undergoing elective~     inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in~     pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with~     a caudal block before the onset of a painful stimulus, we can decrease central nervous~     system sensitization and reduce postoperative analgesic requirements~   "
119325|NCT01493999|"~     MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg~     clopidogrel loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet~     reactivity (HPR) after PCI.~      SECONDARY OBJECTIVES: To define the optimal maintenance dose with both prasugrel (5 mg vs.~     10 mg) and clopidogrel (75 mg vs. 150 mg) in patients with HPR for chronic therapy.~      DESIGN: Prospective, Randomized, Open-label, Single-center trial.~      PRIMARY ENDPOINT: Platelet reactivity measured with Multiplate between clopidogrel and~     prasugrel arm at day 4.~   "
119306|NCT01494259|"~     This double-blind, randomized, controlled clinical trial comparing patient-reported pain and~     pain medication/narcotic use between patients randomized to treatment (bupivacaine) or~     placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen~     to have a mastectomy on one side immediately followed with tissue expander placement breast~     reconstruction.~      Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled~     percutaneously-placed pain pumps; neither the participants nor the study staff will know~     participants' treatment. Data on patient-perceived pain and pain medication use will be~     collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and~     at Years 2 and 4 by phone.~      The investigators hypothesize that patients randomized to the treatment (bupivacaine) group~     will have significantly lower pain scores and use less pain medicine than patients who~     receive placebo during the first 90 days following their surgery. The Year 2 and Year 4~     follow-ups are included as tertiary endpoints to capture differences in chronic pain, and~     patients will be asked to complete the same questionnaires as at the Day 90 follow up.~   "
119307|NCT01494246|"~     Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide~     based intervention with two face-to-face visits and e-mail tracking compared to brief advice~     to obtain continued smoking abstinence at 6 and 12 months after intervention.~      Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18~     or older that attend by any reason to the primary care center and that have an e-mail~     account and they checked it at least once a week will be invited to participate. The~     enrolled participants will be randomly divided into control (N=532) and intervention group~     (N=532). An intensive intervention, based on the recommendations of the clinical practice~     guides, that will include six contacts (2 face-to-face and 4 by e-mail) will be applied to~     the intervention group. Control group will receive brief advice.~      The main dependent variable will be continued abstinence of tobacco consumption at six and~     twelve months after the beginning of the intervention which will be validated by and a~     carbon monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary~     variables will include: stage change on the quitting smoking process and evaluation of the~     effectiveness on the reduction of the number of smoked cigarettes at six and twelve months~     after intervention. A descriptive analysis of all variables will be done. A multivariate~     analysis will be undertaken to assess differences among intervention and control group;~     logistic regression for dichotomic variables and lineal regression for continuous variables.~   "
119308|NCT01494233|"~     The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of~     dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).~   "
119309|NCT01494220|"~     Bispectral index (BIS) monitoring during living donor liver transplantation (LDLT) may be~     influenced with several factors rather than the depth of anesthesia such as bradycardia,~     hypotension, hypothermia, and mixed venous oxygen saturation (SvO2). The investigators~     tested the validity and the independent factors which may alter of BIS readings during LDLT.~      Up to the investigators best knowledge, the independent predictors for BIS monitoring were~     not identified yet during the three phases of liver transplantation.~   "
119310|NCT01494207|"~     The main aim of this study is to measure the effectiveness of a worksite health promotion~     programme on improving physical activity behaviour and associated biological risk factors~     for cardiovascular disease among South African employees at increased risk for~     cardiovascular diseases. Additionally, the investigators will conduct an economic evaluation~     to determine the associated cost- effectiveness of these health related interventions~     offered at South African companies.~      The investigators hypothesize that employees who receive the intervention counseling will~     have increased levels of physical activity and reduced risk for cardiovascular disease~     compared to those in the control group.~   "
119311|NCT01494194|"~     Air Structuring Protein (ASP) is a small protein derived from a fungus which is already~     widely used to produce enzymes that are added to foods. ASP has the possibility of~     stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential~     ice-cream ingredient.~      Toxicological tests have also been carried out to further confirm the safety of the material~     and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.~      As part of the safety evaluation of a new protein for use in foods, the potential~     allergenicity is also investigated and Unilever is sponsoring a study to evaluate this~     aspect of ASP. This study will investigate:~        -  Whether ASP has the potential to elicit a positive skin prick test (SPT) in a~          population of participants with proven sensitivity to mould.~        -  Whether ASP is responsible for any positive SPT reactions, should they occur.~        -  And if any positive SPT reactions to ASP occur, whether such reactions are clinically~          relevant with respect to food allergy.~      The study is divided in three stages. In Stage 1 and Stage 2, the SPT is open label, which~     means that both the participant and the study doctor will know which materials are being~     tested.~      In Stage 3, the food challenge has a crossover design, meaning that participants will take~     one of the products (ASP or placebo [food containing no ASP]) during the first half of the~     study and the other treatment during the second half. The order of ASP and placebo will be~     decided randomly, like tossing a coin. To make the comparison between ASP and placebo as~     fair as possible, the food challenge is double blinded. This means that neither the~     participant nor the study doctor will know which kind of products (ASP or placebo) the~     participant is taking.~      This is a multi centre study which is taking place in the UK.~   "
119312|NCT01494181|"~     Plan of investigation:~      This is an observational cohort study to determine the effect of OSA, independent of other~     risk factors, on postoperative vascular events. The study is conceived, designed and will be~     conducted, and analyzed independent to any company. There is no commercial sponsorship.~   "
119326|NCT01493986|"~     Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA~     dose is one of the strategies to reduce this risk. For upper limb blocks it is well~     documented that ultrasound guidance allows a significant lower dose of LA for interscalene~     and axillary blocks than with guidance by peripheral nerve stimulation. However, a~     corresponding difference has not yet been found for supraclavicular and infraclavicular~     blocks. The aim of the present study is to define the minimum effective volume of~     ropivacaine 7.5 mg/ml when using the LSIB method.~   "
119327|NCT01493973|"~     Friedreich's ataxia (FRDA) is a rare genetic disorder characterised by severe neurological~     disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin~     deficiency. Although several drugs have been proposed, there is no available treatment. Four~     trials recently demonstrated that erythropoietin can increase the intracellular levels of~     frataxin. The present project is aimed at testing a long term therapeutic approach using~     erythropoietin, which is an already available and commercialised drug. The study will test~     the effect of erythropoietin on exercise capacity, which is reduced in patients with FRDA.~     Additional objectives of the study will be the drug's safety and tolerability, and its~     effect on frataxin, blood vessel reactivity, heart functional indexes, and disease~     progression.~   "
119313|NCT01494168|"~     Introduction:~      Obesity is a major public health problem, associated with many morbidities, including~     metabolic and cardiovascular disease (CVD). High blood pressure (hypertension) is the most~     common comorbidity and one of the major risk factors for CVD and kidney failure. It has been~     described an almost linear relationship between body mass index (BMI) and the level of blood~     pressure (BP), but the mechanisms underlying this relationship are complex and incompletely~     understood : activation of renin-angiotensin-aldosterone and sympathetic nervous systems,~     alterations in systemic hemodynamics and arterial parameters; a significant correlation~     between overall and / or visceral obesity and arterial stiffness assessed by carotid-femoral~     pulse wave velocity (PWV) has been observed.~      By its effectiveness in terms of magnitude and sustainability of weight loss, bariatric~     surgery is becoming increasingly important in the management of obesity and the prevention~     of its comorbidities. It reduces all-cause as well as CV mortality. Bariatric surgery allows~     a resolution of the metabolic syndrome (in 2 out of 3 patients) and diabetes (in 5 out of 6~     patients), but its effect on blood pressure remains inconstant and transient. The reasons~     for this limitation and the detailed effects of bariatric surgery on hemodynamics and~     arterial parameters have been poorly studied. Of note, a reduction in left ventricular~     hypertrophy, an improvement in diastolic dysfunction and aortic distensibility assessed by~     ultrasound or MRI have been observed.~   "
119314|NCT01494155|"~     A standard treatment for patients with pancreatic cancer is standard photon radiation in~     combination with the chemotherapy drug, capecitabine. In this research study the~     investigators are using standard photon radiation or a different type of radiation therapy~     called proton beam radiation and adding hydroxychloroquine to be used in combination with~     capecitabine.~      In this research study, the investigators are looking to determine if proton or photon beam~     radiation in combination with hydroxychloroquine and capecitabine is effective in~     controlling your cancer growth.~   "
119315|NCT01494142|"~     The purpose of this multi-center, clinical registry study is to determine genetic markers~     associated with susceptibility of AD patients to infections and to also serve as a potential~     participant database for future studies.~   "
119316|NCT01494116|"~     The purpose of this study is to determine the impact of syringe size on the amount of time~     it takes a health care provider to administer a known volume (900 mL) of resuscitation fluid~     to a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size~     will impact fluid resuscitation time.~   "
119317|NCT01494103|"~     Patients will be receiving a stem cell transplant as treatment for their disease. As part of~     the stem cell transplant, patients will be given very strong doses of chemotherapy, which~     will kill all their existing stem cells.~      A close relative of the patient will be identified, whose stem cells are not a perfect match~     for the patient's, but can be used. This type of transplant is called allogeneic, meaning~     that the cells are from a donor. With this type of donor who is not a perfect match, there~     is typically an increased risk of developing GvHD, and a longer delay in the recovery of the~     immune system. Seventy to ninety percent of people who receive unchanged marrow or stem~     cells from this type of donor will develop severe GvHD.~      GvHD is a serious and sometimes fatal side-effect of stem cell transplant. GvHD occurs when~     the new donor cells (graft) recognize that the body tissues of the patient (host) are~     different from those of the donor. When this happens, cells in the graft may attack the host~     organs, primarily the skin, liver and intestines, causing severe rashes, diarrhea, liver~     disease, and even death. GvHD is caused by a type of immune cell in the graft called T~     cells.~      While this stem cell selection procedure will reduce the risk of GvHD, it will also result~     in slower recovery of the patient's immune system. As the immune system is responsible for~     fighting infections in your body, a longer recovery time after a transplant means that the~     patient may be at increased risk for infections which can become life-threatening. In some~     patients, the immune system can also fight leukemia cells and reduce the risk of relapse.~      In this study, investigators are trying to see whether they can make special T cells in the~     laboratory that can be given to the patient to help their immune system recover faster. As a~     safety measure, we want to program the T cells so that if, after they have been given to~     the patient, they start to cause GvHD, we can destroy them (suicide gene).~      Investigators will obtain T cells from a donor, culture them in the laboratory, and then~     introduce the suicide gene which makes the cells sensitive to a specific drug called~     AP1903. If the specially modified T cells begin to cause GvHD, the investigators can kill~     the cells by administering AP1903 to the patient. We have had encouraging results in a~     previous study regarding the effective elimination of T cells causing GvHD in vitro, whilst~     sparing a sufficient number of T cells to fight infection and potentially cancer.~      More specifically, T cells made to carry a gene called iCasp9 can be killed when they~     encounter the drug AP1903. To get the iCasp9 gene into T cells, we insert it using a virus~     called a retrovirus that has been made for this study. The drug (AP1903) that will be used~     to activate the iCasp9 is an experimental drug that has been tested in a study in normal~     donors with no bad side-effects. We hope we can use this drug to kill the T cells. Other~     drugs that kill or damage T cells have helped GvHD in many studies, but with a more profound~     reduction of immune defense. However, if the patient develops significant GvHD, they will~     also receive standard therapy for this complication, in addition to the experimental drug.~      The major purpose of this study is to find a safe and effective dose of iCasp9 T cells~     that can be given to patients who receive an allogeneic stem cell transplant. Another~     important purpose of this study is to find out whether these special T cells can help the~     patient's immune system recover faster after the transplant than they would have otherwise.~   "
119318|NCT01494090|"~     Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary~     and secondary prevention of cardiovascular events. Many clinical and experimental studies~     support also a potential beneficial effect of statin therapy on venous thromboembolism~     (VTE). Patients with hip fracture are at high risk of VTE and cardiovascular events.~      The aim of this study is to evaluate the efficacy and the tolerance of a statin~     (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic~     events and the global mortality at six months.~      Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the~     upper portion of the femur (hip fracture) are eligible to participate to this multicentre,~     randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5~     or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an~     adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other~     acute ischemic arterial event, or all-cause death.~      Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients~     will be required for the study to have 80% power to detect a 30% reduction in the relative~     risk with rosuvastatin (with a two-sided alpha level of 5%).~      The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in~     patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and~     global mortality at six months.~   "
119319|NCT01494077|"~     The purpose of this research project is to determine if pancreatic cyst fluid can be diluted~     and provide an accurate Carcinoembryonic Antigen (CEA) level. The investigators hypothesis~     is that pancreatic cyst fluid obtained by EUS-FNA can be diluted effectively and accurately~     for the measurement of CEA levels.~   "
119320|NCT01494064|"~     This study seeks to assess the impact of the standardization of nursing supervision of~     patients with hepatic encephalopathy using a grid of appropriate surveillance for the~     prevention of complications in the ICU.~   "
119321|NCT01494051|"~     The study also determines if eating a diet higher in protein alters body composition, energy~     balance and metabolic control among patients with a long-chain fatty acid oxidation~     disorder.~   "
119322|NCT01494038|"~     Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income~     settings and can be a serious complication for HIV-infected pregnant women and their~     infants. Isoniazid (INH) preventive therapy (IPT) is effective for HIV-infected adults, but~     the safety of IPT in pregnant women is unknown. This study will evaluate the safety of IPT~     among HIV-infected pregnant women.~   "
119323|NCT01494025|"~     Elevated fat levels within skeletal muscle cells (intramyocellular lipids) are highly~     correlated with muscle and whole-body insulin resistance, and more prevalent in obesity. The~     molecular links and metabolic shifts driving this association remain open to debate, but~     notably, reduced muscle mitochondrial fatty acid (FA) ß-oxidation is more prevalent among~     insulin-resistant/diabetic persons. Therefore, discovery of biomarkers reflective of the~     status of an individual's muscle FA ß-oxidation activity or capacity would have tremendous~     prognostic and diagnostic value in terms of diabetes. Furthermore, characterization of~     metabolites associated with muscle mitochondrial fat metabolism should uncover candidate~     signaling factors which tie FA ß-oxidation to insulin signaling. The investigators propose~     to identify, for the first time, specific biomarkers of muscle FA ß-oxidation using multiple~     metabolomic analytical platforms to compare metabolite profiles in samples derived from~     biological systems displaying disparate muscle fat combustion. The current experiment will~     test whether plasma metabolites and/or metabolite signatures that track efficient muscular~     FA ß-oxidation can be experimentally increased in obese, insulin-resistant subjects via a~     diet-exercise regimen designed to improve muscle fitness and FA combustion.~   "
119324|NCT01494012|"~     This phase I trial studies the side effects and the best dose of stereotactic body radiation~     therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary~     peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less~     damage to normal tissue.~   "
119329|NCT01493947|"~     Study objectives:~        -  To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream~          in subjects with papulopustular rosacea after 16-week topical treatment.~        -  And to compare, for subjects initially successfully treated by 16 weeks treatment,~          Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period~          by assessing, the time of first relapse, the relapse rate, and the number of days free~          of treatment~   "
119330|NCT01493934|"~     Insulin resistance, characterised by a depressed cellular sensitivity to insulin in~     insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no~     diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality,~     whatever the cause, but, as a majority, cardiovascular diseases.~      In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an~     increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led~     to grow in a near future, because of the increase of diabetes mellitus and obesity~     prevalence.~      Actually, there is no simple tool to measure insulin resistance. The gold standard technique~     remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this~     technique render it unsuitable for routine clinical use. Many methods or index have been~     proposed to assess insulin resistance in human, but none have shown enough relevance to be~     used in clinical use.~      Within the investigators U877 INSERM team, the investigators previously performed in vivo~     biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose~     transport, radiolabelled with123 iodine, with and without insulin, on the one hand in~     genetically diabetic mice (db/db), consequently having a severe insulin resistance and in~     the other hand in rats with acquired insulin resistance after a fructose diet.~      The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose~     transport variations in insulin sensible organs. Then, the investigators developed a fast~     and simple imaging protocol with a small animal gamma camera, which allows the obtaining of~     an insulin resistance index for each organ, directly transferable to human.~      The investigators project is to transfer to human this measurement technique, perfectly~     validated in animal.~      The main goal of this monocentric phase I-II study is to evaluate the tolerance to the~     insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and~     in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2~     diabetic patients.~      The investigators secondary goals will be to evaluate feasibility and reproducibility of the~     measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure~     insulin resistance.~   "
119331|NCT01493921|"~     Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate~     measured outcomes for skin lesion treatment. In addition to the high complete response rate~     (90.0%) as compared with the conventional therapy, the most significant result was that no~     undesirable side effects were associated with the use of SR-T100 gel. The result also shows~     approximately 80% of study subjects had a complete response in phase II clinical trial~     conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers~     beneficial therapeutic values in treatment of AK is harmless to the skin as well as high~     tolerance level displayed by majority of patients.~   "
119332|NCT01493908|"~     The efficacy of the placebo effect has been proved in many prior studies by comparing the~     symptoms and measures of patients. Placebo has been proved to help in treating illnesses~     such as depression, stomach ulcer and chronic headaches.~      A Meta analysis checked 47 studies about placebo and showed great significance when a~     patient is treated with placebo pill, no active substance, just by activating conditioning~     and expectation mechanism in his body, thus providing to the healing process, and that is~     it's importance.~      In recent years studies established a relationship between marketing variables (such as~     price, label) to the efficacy of a product. In addition- a unique research run in 2008~     showed a significant relationship between the marketing strategies and the efficacy of~     medication; more specifically, patients in this research experienced less (controlled) pain~     when treated with placebo medication introduced to them as more expensive than patients~     treated with placebo medication that was introduced to them as much cheaper. All patients~     were treated with the exact same medication.~      In the investigator's experiment the investigators design a laboratory experiment to~     determine if marketing factors could invoke the placebo effects described earlier. For the~     initial laboratory experiment, we decided to examine the difference in price, on the~     efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the~     patient's wrist.~      The investigators study hypothesis is that marketing variables such as price and brand name~     will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater~     influence when the patient is aware of its price compared to one who is not.~   "
119333|NCT01493895|"~     For centuries, light has been a well-known and effective healing method. In the beginning of~     the 20th century there was a first attempt to condense light energy and distribute it in~     higher levels, a use that was successfully applied on many soldiers wounded in the Second~     World War. The laser, which is based on the quantum phenomenon of stimulated emission, was~     first demonstrated in the beginning of the 1960s and immediately received many applications~     in all areas of medicine.Many different studies were carried out in the past decade trying~     to assess the effect of laser therapy on properties of healing wounds. This study aim to~     assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of~     non-healing diabetic foot ulcers.~   "
119334|NCT01493882|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current~     treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or~     montelukast for at least 4 weeks.~   "
119335|NCT01493869|"~     The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75~     mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects.~     Another objective is to assess the safety and tolerability of cabozantinib in these adult~     subjects.~   "
119336|NCT01493856|"~     The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of~     combination of rosuvastatin and CS-866 and DWJ1276 alone.~   "
119337|NCT01493843|"~     This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the~     efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with~     and without GDC-0941 in patients with previously untreated advanced or recurrent non-small~     cell lung cancer (NSCLC). Patients will be randomized to receive 4 cycles of~     carboplatin/paclitaxel and either GDC-0941 or placebo, with (patients with non-squamous~     NSCLC) or without (patients with squamous NSCLC) bevacizumab. Anticipated time on study~     treatment is until disease progression or intolerable toxicity occurs. Patients in placebo~     arms with disease progression may cross over to open-label active GDC-0941.~   "
119338|NCT01493830|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with~     neuroblastoma.~   "
119340|NCT01493804|"~     Background:~      - Different regions of the brain are activated when a person performs a task.~     Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect~     changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes~     in blood flow. These tests can detect local changes in brain activity in a safe and~     noninvasive way. Researchers want to study brain activity more closely by combining these~     tests.~      Objectives:~      - To use EEG and NIRS to study brain activity during specific tasks.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have between one and five testing sessions. Each session will be 1 to~          2 hours long. The tests given at each session will be determined by the researchers.~        -  Participants will have EEG and NIRS tests, given either separately or together. During~          these tests, participants will perform tasks of thinking and reasoning.~        -  Participants may also complete optional tests of thinking and reasoning. These tests~          will be given on paper or on a computer.~   "
119341|NCT01493791|"~     Background:~      - CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining~     pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases,~     menstrual periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual~     bleeding in women with fibroids, it may be able to treat abnormal periods in women without~     fibroids.~      Objectives:~      - To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.~      Eligibility:~      - Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests. An ultrasound with fluid of the uterus will test for~          fibroids. Uterine cells will be collected for biopsy.~        -  For the next three menstrual cycles, participants will take either CDB-2914 or a~          placebo. Treatment will be studied with blood tests and symptom diaries.~        -  At the end of the treatment, participants have three options. They can have surgery at~          the Clinical Center or have another 3 months of CDB-2914. The third option is to stop~          treatment at the Clinical Center.~        -  Surgery will be either uterine ablation or hysterectomy. Only women older than age 33~          may have a hysterectomy. Blood and urine samples will be collected after surgery.~        -  Both surgery and further treatment participants will have followup exams.~        -  All participants will have a final followup exam 1 year after stopping treatment.~   "
119342|NCT01493778|"~     This trial is conducted in Asia, Europe and North America. The purpose of the trial is to~     evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in~     previously untreated children with haemophilia A.~   "
119343|NCT01493765|"~     The goal of this project is to improve the efficiency of training and assessment of~     technical skill in surgical treatment of otologic disease. Through previous funding, we have~     developed an intuitive virtual simulation environment to be used as an adjuvant for teaching~     temporal bone surgery. Using direct-volume visualization techniques with integrated~     stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a~     straightforward, low-cost learning environment ready for translation into a practical~     training and assessment tool. This application challenges and seeks to shift current~     practice in clinical training by translating the simulation environment into a vehicle for~     curriculum development, technical skills assessment, and dissemination. The intent is to~     provide more accessible, inexpensive, safe, and deliberate practice with objective and~     continuous quantitative, objective assessment in the early stages of training.~   "
119344|NCT01493752|"~     Diets rich in fruit and vegetables reduce the risk of strokes and heart attacks, however the~     exact cause of this beneficial effect is uncertain. Evidence suggests that certain~     vegetables, including beetroot and the green leafy vegetables, possess high inorganic~     nitrate concentrations. The investigators recent evidence suggests that inorganic nitrate~     provides a source of gas called nitric oxide in the body that exerts a number of beneficial~     effects upon the heart and blood vessels . The investigators have previously shown that~     beetroot juice ingestion improves blood vessel (vascular endothelial) and platelet function~     in healthy volunteers. Studies by the investigators show that these effects are due to~     conversion of nitrate to nitrite by symbiotic (helpful) bacteria (located on the tongue) and~     subsequent conversion of nitrite to nitric oxide in blood vessels. The investigators now~     wish to explore whether dietary nitrate, via its beneficial effects on platelets and blood~     vessels, might improve indices of atherosclerotic disease progression in high risk~     individuals (hypercholesterolemics). Recruits will have high cholesterol and no known~     atherosclerosis and will not yet be on any anti-cholesterol medications. Volunteers will~     consume a daily dose of beetroot juice or placebo nitrate-free juice for six weeks. Vascular~     function will be assessed using non-invasive techniques at the beginning and at the end of~     the study using ultrasound measurement of flow mediated dilatation (FMD) of the brachial~     artery in the arm and pulse wave analysis (PWA) and pulse wave velocity (PWV) to measure~     arterial compliance. To assess impact on platelet function, blood samples will also be taken~     at the start and at the end of the study.~   "
119345|NCT01493739|"~     This study aims on the combinatorial results of cytology, histopathology and microbiology~     obatined by EBUS-TBNA for unselected mediastina lesions.~   "
119346|NCT01493726|"~     This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072~     (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.~   "
119347|NCT01493713|"~     The purpose of this study is to to evaluate the correlation of overall objective response~     according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic~     response by CT, and histopathologic response in patients with resectable hepatic metastasis~     secondary to colorectal cancer treated with bevacizumab in combination with XELOX.~   "
119348|NCT01493700|"~     The purpose of this study is to compare the effect of electrically heated humidifier on the~     body temperature during shoulder arthroscopy.~   "
119349|NCT01493687|"~     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its~     vehicle when applied once daily, at bed time, during a 12 week period in subjects with~     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.~   "
119363|NCT01493505|"~     The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination~     with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.~   "
119351|NCT01493661|"~     Sleep is a physiological state considered essential for health and human survival. The~     prevalence of chronic sleep restriction has increased in modern society, as well as the~     effects of the same health concerns about various aspects, including the physiological and~     neurobehavioral. The objective of this study is to identify the neurobehavioral and~     physiological responses of healthy men with different needs of total sleep time (TST)~     submitted to chronic sleep restriction. Participants in this study will be 30 male~     volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with~     TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7~     and 8h. The TST will be established by the constant and continuous use of actigraphy for 10~     days prior to the onset of the experimental protocol. All volunteers will undergo medical~     and polysomnography (PSG) examination to detect the presence or not of changes in sleep as~     well as other health problem that prevents their participation in the study. The~     experimental protocol consists of a basal night of sleep, five consecutive nights of chronic~     sleep restriction to 25% of TST in the beginning night and a night of recovery, which will~     be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up~     in each day, the volunteer will undergo tests to assess the physiological and~     neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).~   "
119352|NCT01493648|"~     This proposal will explore muscle function (strength and endurance) in men and women~     suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle~     symptoms will be explored. Also, the investigators will assess the potential usefulness of~     vitamin D supplementation in a randomized control trial.~   "
119353|NCT01493635|"~     The World Health Organization analgesic ladder for cancer pain relief is an internationally~     used approach to managing cancer pain. Patients generally start on Step 1 of the ladder~     (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2~     which involves a stronger pain killer (weak opioid such as codeine). If pain is still not~     controlled they progress to Step 3 of the ladder which is a strong opioid (such as~     morphine). Work to date has suggested that Step 2 may be unnecessary and most patients~     usually require Step 3 analgesia. The TVT trial aims to examine the standard approach (Step~     1-Step2-Step-3) versus a two step approach (Step 1-Step 3).~   "
119354|NCT01493622|"~     The purpose of this study is to determine whether minocycline are effective in the treatment~     of negative and cognitive symptoms in schizophrenia.~   "
119355|NCT01493609|"~     The CLICK-EAST research project is an investigation of the efficacy of a computer based~     learning programme which aims to teach the fundamental components of social attention to~     young children with autism spectrum disorder (ASD). Social attention describes the process~     of choosing to look at or listen to social information in the world, normally in preference~     to any other available information. Social information normally refers to people: for~     example, we notice human voices more than birdsong or traffic noise, even if the latter is~     louder. As a rule, children with ASD are less likely to prioritise this kind of social~     information. This is thought to have a significant effect on their development and~     behaviour. For example, a child who doesn't listen to what his parents say may be very slow~     to learn language, and may also fail to follow important instructions. Our goal is to create~     a new learning programme, in the form of an enjoyable computer game, which encourages~     children to practise the skills of looking at and listening to people, despite the presence~     of distracting information. The investigators will develop the game with the input of an~     advisory group of parents and teachers of children with ASD as well as some young adults~     with an ASD diagnosis. Then they will perform a trial of the game with a group of~     preschoolers with ASD and their families, in order to determine whether the game is having a~     positive effect on the children's abilities.~   "
119356|NCT01493596|"~     Primary Objective:~      • To evaluate the safety and tolerability of ascending single oral doses of CPP-115~      Secondary Objective:~      • To determine the pharmacokinetic profiles of CPP-115 following administration of a~     ascending single oral doses~   "
119357|NCT01493583|"~     Recent evidence has pointed to distinct alterations of brain functions in obese subjects~     some of which may even be causative for their obesity. The objective of this study was to~     examine food and non food related alterations in brain functions after excessive weight loss~     due to Roux-en Y gastric bypass surgery (RYGB), one of the most successful therapeutic~     approaches for long lasting weight loss. The investigators hypothesized that obese as~     compared with lean women show an altered activation pattern in the brain areas involved in~     the homeostatic regulation of eating behavior, i.e. the hypothalamus, in reward-related~     brain areas, such as the orbital frontal cortex (OFC) and the striatum as well as in~     prefrontal inhibitory control areas. Furthermore, the investigators hypothesized that women~     who had undergone a RYGB operation show a brain activity pattern that more closely mimics~     that of lean than severely obese women. In a supplementary test the investigators will~     assess gastrointestinal and metabolic response to a standardized meal in order to elucidate~     putative correlation of these responses with the results of fMRI scannings.~   "
119358|NCT01493570|"~     Due to the exploratory nature of this trial, there is no primary objective in a confirmatory~     sense. The study aims~      - to evaluate the effect of different doses of BI 409306 on biomarker and to assess the~     exposure of BI 409306~   "
119359|NCT01493557|"~     This is a prospective and open label study that aims to enroll approximately 1200 patients~     with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free~     of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately~     125 sites in North America will be recruited. Patients who report GIS during the 3 month~     treatment period will be randomized to one of two management strategies, and data~     documenting the intensity and duration of the GIS will be collected.~   "
119360|NCT01493544|"~     PUMA is an observational, multicentre, multinational, cross-sectional study with primary~     care physicians (primary care, general and family physicians). Participants will be selected~     sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who~     attend primary care consultation (primary care, general and family physicians). The~     inclusion visit will be a regularly scheduled or spontaneous consultation for patients, and~     this appointment with the physician will not depend on the study. During the appointment,~     data will be collected from the patient and the physician.~   "
119773|NCT01488162|"~     This multi-center, prospective, observational study will describe the management of~     relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected~     for 2 years.~   "
119364|NCT01493492|"~     As a noninvasive examination, urinary proteomics is a very useful tool to identify renal~     disease. The purpose of the present study was to find differential proteins among patient~     with SIRS and sepsis(included survivors and non-survivors), and to screen potential~     biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were~     identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with~     the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO)~     Database and KEGG pathway Database. The differentially expressed proteins were verified by~     Western blot by another sample collected from clinical.~   "
119365|NCT01493479|"~     90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in~     patients who have received previous treatment for lymphoma. More than two-thirds of the~     patients who achieve CR go on to experience durable remissions lasting for years. Despite~     these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular~     lymphoma there is very little data using RIT in previously untreated follicular lymphoma.~     The objective of this trial is to evaluate the safety and efficacy of two fractions of~     Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.~   "
119366|NCT01493466|"~     Serum proteomics is a very useful tool to identify various disease. The purpose of the~     present study was to find differential proteins among patient with normal, SIRS, sepsis,~     severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum~     proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was~     performed with the Mascot software and the International Protein Index (IPI) and the Gene~     Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were~     verified by Western blot by another sample collected from clinical.~   "
119367|NCT01493453|"~     In particular circumstances T cells can be an effective treatment for malignant disease, for~     example, donor lymphocyte infusions following allogeneic transplants or treatment of EBV~     related lymphomas post allograft. However, many common cancers are poorly recognised by the~     immune system in part because of a lack of suitable T cell targets and in part because of~     defects in antigen presentation by tumours (Garrido, et al 1997). Genetically modified T~     cells engineered to express chimeric immune receptors (CIRs) on their cell surface can~     bypass the need for MHC presentation and thus represent an attractive approach to~     immunotherapy (Gross, et al 1989).~   "
119368|NCT01493440|"~     Atosiban, administered at embryo transfer, can improve the implantation rate and the~     clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET~     (in-vitro fertilization and embryo transfer).~   "
119369|NCT01493427|"~     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution~     without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or~     bimatoprost 0.01% ophthalmic solution monotherapy.~   "
119370|NCT01493414|"~     The primary objective of this study is collect additional safety of INC424 in patients with~     Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia~     Myelofibrosis, who have either received prior treatment with commercially available agents~     or who have never received treatment.~   "
119371|NCT01493401|"~     Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI~     (UUI) and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and~     SUI. Patients might perceive urgency when they have an incompetent urethra and a full~     bladder.~      Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle.~     Increased levels of NGF have been reported in the bladder tissue and urine of patients with~     overactive bladder (OAB).~      If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF~     level might be a biomarker in the differential diagnosis of MUI in women.~      Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were~     improved. So, we might expect that the remnant OAB symptom including urgency incontinence~     can be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI~     patients.~      We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis~     and as a prognostic marker for predicting the improvement of OAB symptom after midurethral~     slings.~   "
119372|NCT01493388|"~     This study is conducted in Africa. The aim of this study is to estimate the percentage of~     children and adolescents below or equal to 15 years in Tunisia with acceptably controlled~     diabetes mellitus type 1.~   "
119373|NCT01493375|"~     In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection~     is a very serious condition and despite extensive prophylactic measures, prosthetic~     infections appear in 1-2 percent of the operated patients.~      It is difficult to diagnose prosthetic infection with the techniques applied so far and~     incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections~     might lead to prolonged pain and invalidity.~      The purpose of this study is to examine the value of these three techniques applied as a~     supplement to the existing technology and on this basis to prepare an algorithm for the~     examination of joint prosthesis infection.~   "
119374|NCT01493362|"~     This study will use positron emission tomography imaging to investigate the dopamine systems~     in people with bulimia nervosa.~   "
119375|NCT01493349|"~     Colonic diverticular disease is a highly prevalent condition in Western populations. The~     prevalence increases age-dependently from 5% at 40 years to 65% by the age of 85 years~     (1-3). The majority remain asymptomatic. However, a significant proportion of the patient~     population develops complications, such as diverticulitis with or without symptoms (10-20%)~     (1, 4-10). Perforated diverticulitis is rare with an estimated incidence of 4 per 100.000~     per year, but the associated mortality rate is 22% to 39% (9, 11, 12). In the United States,~     the complications related to diverticular disease account for 130.000 hospitalizations each~     year, resulting in substantial health care costs (13). In Europe, it is estimated that~     approximately 23.600 deaths per year can be attributed to complicated diverticular disease,~     and the mortality will probably increase in the future due to the aging population (15-17).~     Several case studies report an overall increase in the incidence of diverticulitis, based on~     the increase in hospitalizations (18). Kang et al, reported a 16% increased male admission~     rate and 12% female admission rate for diverticulitis, between 1989/1990 and 1999/2000 (19).~     Aging and the Western diet, low in fiber and high in fat, in combination with increased~     intraluminal pressure and alterations in colonic motility are considered important~     etiological factors. A disturbance in large bowel motility is suggested to be a common~     pathophysiological feature in IBS and diverticular disease (20, 21). Based on observations~     that IBD, subgroups of IBS and (symptomatic) diverticular disease share clinical symptoms,~     the hypothesis is derived that they might also share pathophysiological factors like low~     grade inflammation, changed microbiota composition and activity, and increased intestinal~     permeability. The identification of clinical and pathophysiological factors associated with~     an increased risk for complicated diverticular disease may help to identify patients with~     diverticular disease, prevent complications, develop strategies to improve quality of life~     and reduce the related health care costs. Therefore we aim to investigate the composition of~     luminal and mucosal intestinal microbiota and the intestinal permeability in the development~     of diverticular disease and complicated diverticular disease. We hypothesize that both the~     intestinal microbiota and intestinal permeability are altered in patients with (current- or~     previous history of complicated) diverticular disease.~   "
119376|NCT01493336|"~     This randomized, open-label, two-way crossover study will evaluate the relative~     bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus~     commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be~     randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2~     of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.~   "
119377|NCT01493323|"~     Suicidal behaviour (SB) represents a major public health problem, costing life in more that~     one million people every year worldwide. Even if SB is considered as a consequence of social~     adversity and depression, these stress factors are often necessary but not sufficient to~     explain the occurrence of a suicidal act. A preliminary study suggests that an increased~     perception of psychic pain during a major depressive disorder increases the risk of suicide~     behaviour. The investigators aimed to investigate the relationship between social exclusion~     (a classic trigger of psychic pain) and SB and improve our knowledge about the~     physiopathology of this domain.~   "
119378|NCT01493310|"~     This trial will find the best dose of mifepristone when given together with nab-paclitaxel~     (Abraxane) based on the side effects of the two drugs in patients with advanced breast~     cancer.~      Patients will be randomized to receive nab-paclitaxel with or without mifepristone during~     the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel~     with mifepristone until their disease worsens or they experience an unacceptable side~     effect.~      This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The~     study will first test the lowest dose in a small group of patients and if they do not have~     bad side effects, higher doses will be tested.~   "
119379|NCT01493297|"~     The objective of this study is to investigate the effect of vitamin A and carotenoids on~     iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and~     carotenoids have been reported to enhance the nonheme iron absorption, but the results from~     human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have~     consistently reported an increase in iron absorption, whereas stable and radio isotopes~     studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A~     status of the subjects may be a possible explanation for the contradictory findings. In this~     study, iron absorption will be measured from an iron-fortified maize bread meal with or~     without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope~     techniques in Venezuelan women with a range of vitamin A status.~   "
119380|NCT01493284|"~     The purpose of this study is to assess the safety and effectiveness of the SJM Portico~     Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in~     subjects with severe symptomatic aortic stenosis (AS).~   "
119381|NCT01493271|"~     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the~     safety and the effect of RO5093151 on intraocular pressure in patients with ocular~     hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of~     RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the~     possibility to extend to 28 days.~   "
119382|NCT01493258|"~     In this project the investigators seek to utilize our experience for developing a~     comprehensive informatics framework for rapid adaptation and dissemination of Comparative~     Effectiveness Research (CER) products tailored to different categories of health consumers~     including difficult-to-reach patients. Based on our previous successful experience in~     computer-assisted education, the investigators will refine the current CO-ED platform to~     implement and test a novel system for individualized continuous patient education (iCOPE).~     The iCOPE platform will be specifically designed to support rapid adaptation, customization,~     and dissemination of the CER products to the difficult-to-reach populations. The iCOPE~     platform will implement universal means for customized delivery of CER information in the~     format of interactive self-paced educational modules, quick question & answer guides, and~     interactive decision aids. In addition, the iCOPE platform will support the innovative~     concept of continuous patient health education by providing patients with easy access to the~     interactive CER updates via web, MP3 players and phone-based interactive voice response~     (IVR) technology. Though iCOPE will be designed to support the whole spectrum of CER~     products, in this project the investigators will focus on the Comparative Effectiveness~     Research Summary Guide (CERSG) entitled Pills for Type 2 Diabetes.~      The following primary hypothesis will be tested in the RCT: Use of the iCOPE platform will~     be associated with improvement in CERSG knowledge in elderly at 6 months after the~     intervention.~      The investigators will also examine the impact of iCOPE on medication adherence~     self-efficacy, diabetes medication satisfaction, HbA1c, and CERSG acceptance.~   "
119383|NCT01493245|"~     The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients~     with moderate to severe chronic pain who switched from opioid analgesics, as well as the~     safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD.~   "
119384|NCT01493232|"~     In this randomized clinical trial to compare the patients' satisfaction of complete dentures~     with different occlusal forms, after simple randomized sampling of 15 participant that will~     be signed informed consent and their latest teeth was extracted 3 month ago, will be~     selected. For each participant, it will be made 3 set of complete dentures that are variable~     in occlusion only. During the study, dissatisfied participants can leave it. Each set will~     be inserted for 1month in 5 participant randomly. The participants will be examined in two~     stages, after a day and after a week. At the end of month the questionaire will be filled~     out and the pressure under the mandibular denture base will be measured with the pressure~     sensors. Then the second and third denture will be inserted simultaneously.~   "
119385|NCT01493219|"~     The purpose of this study is:~        1. To learn if (MMP-2, MMP-9 and NGAL) which are substances found in blood and urine~          associated with tumors, can be used as tumor markers in the management and treatment of~          glioblastoma.~        2. To study the relationship between MMP-2, MMP-9 and NGAL with quality of life and~          disease symptoms.~   "
119386|NCT01493206|"~     The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal~     cancer improve outcomes without causing significant side effects.~   "
119397|NCT01493063|"~     The aim of the study is to estimate the impact of the protein content of breastmilk at the~     end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.~      The investigators expect a difference of at least 5 points of Development Quotient (DQ) when~     comparing extreme terciles of the protein content of breastmilk at the end of~     hospitalization.~   "
119387|NCT01493193|"~     It is the aim of the study to compare the effects of 6 weeks of either high-intensity~     interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate),~     pyramid, or continuous endurance training, on changes of physical exercise capacity in~     cardiac patients.~      The three exercise arms (isocaloric) are composed as follows:~      Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95%~     HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min;~     Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting~     with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at~     80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered~     afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last~     one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at~     65-70% HRmax, making it a total of 28min.~      All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at~     60-70% HRpeak.~      Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change~     of power output in watt at lactate thresholds at 2 and 4 mmol/l.~   "
119388|NCT01493180|"~     The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for~     patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also,~     safety of OPC-12759 is to be assessed.~   "
119389|NCT01493167|"~     The purpose of study is to verify that WOODCAST Circular system performs safely and~     effectively in its intended use.~   "
119390|NCT01493154|"~     This study will test the safety of an HPV DNA vaccine after it is injected into your muscle~     using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems),~     and will test the ability of the vaccine to help your body's immune system to recognize~     HPV-infected and associated cancer cells. In addition to giving the vaccine using an~     electroporation device, we are giving the vaccine in combination with an immunomodulatory~     agent to further enhance immune responses against HPV-infected and associated cancer cells.~   "
119391|NCT01493141|"~     In recent years hip resurfacing has become a very popular alternative treatment to total hip~     replacement for the treatment of hip arthritis. This procedure has become particularly~     common in the young patient with arthritis because of perceived benefits in terms of~     functional outcome. However, it has recently become apparent that hip resurfacing is~     associated with a range of adverse events, not typically seen in patients with conventional~     hip replacement. These include hip fracture, and failure of bone to grow onto the fixation~     surfaces of the implant. It has also become apparent that hip resurfacing results in the~     release of high concentrations of dissolved metals in the bloodstream, such as cobalt and~     chromium. Whilst small concentrations of these metals are essential for normal body~     functions, such as making red blood cells, in high concentrations their effects can be toxic~     to many cells and organs of the body, such as bone, the brain, heart, liver and kidneys, as~     well as disturbing hormones and blood cholesterol levels. Whilst several studies have~     documented levels of these metal ions of 440 times normal levels in hip resurfacing~     patients, there are no studies that have examined whether these levels are having a toxic~     effect on the various organ systems of the body (with the exception of renal function). In~     this study we plan to explore whether there are differences in bone mineral density,~     accumulation of metal ions in the brain, and other solid organs, heart and hormonal function~     between subjects who have had a hip resurfacing 5 or more years previously compared to an~     individually matched group of subjects after conventional hip replacement.~   "
119392|NCT01493128|"~     The aim of this work is to study the prevalence of T-tubular system in left and right~     myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and~     permanent atrial fibrillation. Furthermore, since current information is lacking on the key~     Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it~     will be investigated whether a regulation of these proteins could be an underlying cause of~     the disease. Mitochondrial function will also studied.~        1. The investigators hypothesize that both structure of sarcolemma and localization of key~          Ca2+-handling proteins are altered in patients with atrial fibrillation compared with~          patients in sinus rhythm.~        2. The investigators hypothesize that mitochondrial function is altered in patients with~          atrial fibrillation compared with patients in sinus rhythm.~   "
119393|NCT01493115|"~     Primary Objective:~      To compare the pharmacodynamic properties of two different doses of a new insulin glargine~     formulation with 0.4 U/kg Lantus®~      Secondary Objective:~      To compare the pharmacokinetic properties of two different doses of a new insulin glargine~     formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin~     glargine formulation~   "
119394|NCT01493102|"~     The purpose of this study is to evaluate the incidence of hypotension based on the~     discontinuation order of norepinephrine and vasopressin in patients receiving concomitant~     norepinephrine and vasopressin infusions for the treatment of septic shock.~   "
119395|NCT01493089|"~     Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied~     by acid regurgitation and other symptoms, has a substantial negative impact on a patients'~     quality of life. Although a number of treatment options are available, a more effective~     therapy is still required. The failure of proton pump inhibitors (PPIs) to completely~     resolve symptoms is an accepted problem, with approximately 25% of patients with GERD~     continuing to experience the symptoms of heartburn in spite of treatment. This study aims to~     demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn~     associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation~     when compared with delayed-release omeprazole (Losec®).~   "
119396|NCT01493076|"~     Precut-sphincterotomy is a well established alternative after repeated futile attempts for~     common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly~     used devices instruments for pre-cutting are the needle-knife and the Erlangen-type~     precut-sphincterotome. In 1996 a so called baby-sphincterotome (Easy-Cut®, MTW, Wesel,~     Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip~     was developed, which enables cannulation and pre-cutting in one step. Here the investigators~     report on the clinical evaluation of this device.~   "
119783|NCT01488032|"~     The purpose of the study is to prove if there is any difference in the nerve fiber layer~     between patients with normal- and high-tension-glaucoma with similar structural optic nerve~     head parameters.~   "
119398|NCT01493050|"~     The purpose of this study is to see if taking a medication can lower the amount of oxidants~     from food that go into our body. Previous research shows that if the investigators lower the~     oxidants from food in people with diabetes, this simple change lowers different risks for~     heart disease and the worsening of kidney disease. The investigators focus on a specific~     type of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted~     by our group showed that a drug, already approved by the FDA, will lower AGEs in the~     investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have~     been used for a long time in patients with diabetes and kidney disease. While our previous~     study was interesting, it was just too small to be able to be sure that it will help all~     people with diabetes, or if the good effects the investigators found were simply due to~     chance. The investigators are doing this new study to confirm or deny the possibility that~     Renvela® can really help people with diabetes and kidney disease.~   "
119399|NCT01493037|"~     A prospective multi-center study in which patients with an acute heart attack (in the left~     anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty~     followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept~     study designed to document the safety and feasibility of the Pressure Controlled~     Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.~   "
119400|NCT01493024|"~     It is hypothesized that zirconium silicate is safe and well tolerated and more effective~     than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with~     serum potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and~     placebo (null hypothesis). It is hypothesized that zirconium silicate even up to the top~     dose of 10g three times a day is well tolerated.~   "
119401|NCT01493011|"~     Millions of patients die of non-small cell lung cancer (NSCLC) every year. There are several~     methods to treat NSCLC, including surgery, chemotherapy, radiotherapy and bioimmuotherapy.~     Recently, hyperthermia therapy has played an important role in neoplasm therapy. It has~     showed some effect in NSCLC both in animal experiment and clinical practice, yet there is~     little literature about Whole-body Hyperthermia (WBH) with neoplasm. The investigators~     decides to develop this randomized contrasted multicenter clinical study to testify to the~     effect of chemotherapy combined with WBH to treat stage IIIB/IV Non Small Cell Lung Cancer~     (NSCLC).~   "
119402|NCT01492998|"~     In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts~     nuclear receptor FXR by either agonists or antagonists respectively increases or decreases~     the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal~     sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already~     been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290:~     765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone~     given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected~     patients.~   "
119403|NCT01492985|"~     The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is~     expected to induce strong and diverse HIV-specific immune responses in HIV-infected~     patients. The investigators will carry out the clinical therapeutic immunization proof of~     concept trial in HIV infected patients. The investigators propose a multi-center double~     blind randomized versus placebo phase II clinical trial in patients who are chronic~     asymptomatic HIV-infected patients, with undetectable viral load while treated with a potent~     combination of antiviral drugs. Patients will continue antiviral therapy combined with~     either therapeutic vaccination or placebo vaccination. Patients will undergo the procedure~     which includes a prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM~     injections via Biojector (a needle-free injection system) followed by a boost of LIPO-5~     vaccine or placebo also given IM.~      In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine~     arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or~     its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2~     doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost~     vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48.~     Patients will be intensely monitored during the treatment interruption period. After start~     of cART treatment (at the latest in W48), a data collection from clinical car will be~     carried out. A blood sample with W74 will allow to study the persistence ot the immunizing~     responses, 1 year after the injection of the last vaccine/placebo.~      The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after~     stopping all antiviral treatment).~      The main hypothesis for conducting a phase II randomized trial is that immune responses in~     vaccinated patients may be associated with a better control of viral replication following~     c-ART interruption as compared to placebo-vaccinated patients.~   "
119404|NCT01492972|"~     The purpose of this study is to compare the effects, good and/or bad of two treatment~     methods on subjects and their cancer.~      Proton beam radiation therapy is one of the treatments for men with prostate cancer who have~     localized disease. The benefit of the combination with androgen suppression is not~     completely understood. This study will compare the use of hypofraction proton therapy (28~     treatments) alone to proton therapy with androgen suppression therapy.~   "
119405|NCT01492959|"~     This study is conducted in Asia. The aim of this study is to review the efficacy and safety~     of insulin treatment with InnoLet® in daily clinical practice.~   "
119406|NCT01492946|"~     The aim of this retrospective observational study is to determine the impact of preoperative~     nutritional status on postoperative outcome. Elective surgical patients were screened with~     Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for~     body composition. Outcome parameters were collected by patient chart review.~   "
119407|NCT01492933|"~     Background:~      - Studies show that alcohol changes the amount of many brain chemicals. These changes may be~     related to continued drinking, craving for alcohol, and relapse. This study will use~     magnetic resonance imaging (MRI) to look at brain areas and brain chemistry during an~     infusion of alcohol. It will also study how changes in brain chemistry relate to participant~     reports of feeling drunk.~      Objectives:~      - To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry~      Eligibility:~        -  Individuals between 21 and 45 years of age.~        -  Participants will be either light drinkers (1 to 14 standard alcoholic drinks per week)~          or heavy drinkers (20 to 40 standard alcoholic drinks per week). A standard drink is a~          12-ounce beer, a 4-ounce glass of wine, or a shot of liquor.~        -  Participants must be able to go without alcohol for at least 3 days in a row without~          severe withdrawal symptoms.~      Design:~        -  This study requires two or three outpatient visits to the NIH Clinical Center.~        -  Participants will have a physical exam and medical history. Blood and urine samples~          will be collected. Participants' alcohol drinking habits will also be assessed to~          determine whether they may have an alcohol use disorder.~        -  At the first study visit, participants will have an infusion of alcohol. Blood samples~          will be collected to measure blood alcohol levels.~        -  The MRI study visit will take place about 3 days after the first study visit.~          Participants will have an MRI scan of the brain, followed by an infusion of alcohol and~          another scan. Blood samples will be collected.~        -  Participants will complete questionnaires before and after each infusion to measure~          their response to alcohol.~        -  Heavy drinkers will come to the clinic for a third visit to discuss possible future~          treatment and any risky behavior associated with their high levels of alcohol use.~   "
119433|NCT01492595|"~     The proposed study aims to establish a pilot program through a prospective cohort study~     offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of~     TB disease to children <5 years living in the same household as adults diagnosed with~     smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital~   "
119408|NCT01492920|"~     This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works~     compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian~     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing~     chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy~     caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more~     effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.~   "
119409|NCT01492907|"~     Study Design:~      This is a single institution pilot study to recruit 4 patients with operable pancreatic~     cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups~     will receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an~     8 hour period and urine collections over a 24 hour period. In addition, normal pancreatic~     tissue and normal small bowel tissue will be collected by Tissue Procurement from resected~     (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.~   "
119410|NCT01492894|"~     The purpose of this study is to learn the best way to prolong kidney life in patients~     exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by~     the calcineurin inhibitor on kidney biopsy.~   "
119411|NCT01492881|"~     The purpose of this research study is to determine how multiple myeloma responds when the~     study drug vorinostat is added to the standard treatment of bortezomib and pegylated~     liposomal doxorubicin (PLD). After participants complete the three drug combination and if~     their multiple myeloma has decreased, the investigators also want to learn what effects~     (both good and bad) when vorinostat and bortezomib are given to people with multiple myeloma~     over a longer period of time. This type of treatment is called 'Maintenance Therapy'.~   "
119412|NCT01492868|"~     The purpose of this study is to investigate the relationship between viral infections of the~     upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the~     risk of acute bacterial sinusitis over a one year period. The investigators will determine~     the incidence of acute bacterial sinusitis post viral upper respiratory infection and~     identify the viral antecedent infections and other risk factors which predispose to~     infection and ultimately design strategies to reduce the burden of disease and antimicrobial~     resistance.~   "
119413|NCT01492855|"~     The knee menisci are two semicircular fibrocartilaginous structures located between the~     articular cartilage surfaces of the femur and tibia in the medial and lateral joint~     compartments. The main functions of the menisci are shock absorption and load transmission~     in the knee, mainly through distribution of mechanical stress over a large area of the joint~     cartilage.~      The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline~     are associated with poorer outcome.~   "
119414|NCT01492842|"~     The proposed study is a substudy of ATN 106 and a cross sectional study intended to be~     conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all~     youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a~     review of the subjects' medical chart and a collection of an oral rinse sample.~   "
119415|NCT01492829|"~     The investigators will develop, deliver and evaluate a solar powered tablet-based individual~     and group focused HIV/STI prevention intervention with internally displaced women in~     Leogane, Haiti. Internally displaced women will be trained as community health workers to~     deliver the HIV/STI prevention intervention to other internally displaced women.~   "
119416|NCT01492816|"~     The proposed study seeks to continue Connect to Protect® (C2P) community mobilization~     efforts that have developed coalitions that plan for and bring about structural changes for~     purposes of reducing HIV incidence and prevalence among youth in targeted communities at~     nine sites.~   "
119417|NCT01492803|"~     This is a randomized placebo-controlled trial to examine if once daily probiotic therapy~     will lower serum LPS levels and immune activation among HIV-infected youth.~   "
119418|NCT01492790|"~     The purpose of this study is to evaluate if cholecystectomy first (studied group) versus~     sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of~     hospital stay, morbidity/mortality and costs in the management of patients with a suspicion~     of gallstone migration.~   "
119419|NCT01492777|"~     The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE)~     due to a narrow therapeutic window leading to important medical and economical consequences.~     The risk of ADE is increased partly by drug interactions and recently identified genetic~     factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9)~     as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide~     reductase complex subunit 1 (VKORC1).~      The objective is to determine the impact of several genotypes on acenocoumarol treatment and~     on vulnerability to drug-drug interactions.~   "
119420|NCT01492764|"~     This study will test the hypothesis that many human heart rhythm disorders are caused by~     small localized sources, where brief ablation may successfully eliminate the heart rhythm~     disorder.~   "
119421|NCT01492751|"~     The purpose of this study is to evaluate the effectiveness of the three most established~     primary treatments for patients with clinically localized prostate cancer (radical~     prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and~     long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side~     effects. As secondary objectives biochemical disease-free survival, overall survival, and~     prostate cancer-specific survival will be also assessed.~   "
119422|NCT01492738|"~     This study endeavors to examine the relationship between acupuncture, anxiety, and~     performance on a test of working memory. In the study, all participants will complete the~     State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment~     and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for~     20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will~     again complete the STAI survey. Then all subjects will complete the Automated Operations~     Span Task (AOSPAN) which is a computerized test of working memory. Statistical analysis will~     be performed to determine if acupuncture had any effect on State-level anxiety and on~     performance on the AOSPAN.~   "
119434|NCT01492582|"~     This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer~     survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine~     initiation among young cancer survivors, and (2) determining the immune response to and~     safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer~     survivors.~   "
119423|NCT01492725|"~     Patients presenting to the emergency department with acute ischaemic stroke, who are~     eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be~     assessed for dual target major vessel occlusion and mismatch to determine their~     eligibility for randomisation into the trial. If the patient gives informed consent they~     will be randomised 50:50 using central computerised allocation to intra-arterial clot~     retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label,~     blinded endpoint (PROBE) design.~   "
119424|NCT01492712|"~     Anaesthesia for surgical procedures can be provided using a continuous infusion of~     intravenous drug. The most commonly used drug for this technique is propofol. Infusion~     devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a~     target blood concentration. These pharmacokinetic models predict the rate of distribution of~     propofol within the body and also the rate at which it is cleared. In practice, the~     anaesthetist enters patient details such as age, sex and weight as well as a target blood~     concentration of propofol. The infusion device then infuses propofol at the appropriate rate~     to achieve this concentration.~      White and colleagues recently published the Covariates Model for propofol. It is anticipated~     that this model will have reduced bias and inaccuracy compared to the models in current~     clinical use. The VaSCoM study has three objectives:~        1. Prospective validation of the Covariates Model~        2. Modelling of the effect site concentration of propofol~        3. Comparison of propofol concentration in venous and arterial blood samples~      To achieve the above objectives, patients over 18 years of age and undergoing elective~     non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a~     target controlled infusion device programmed with the Covariates Model for propofol. The~     target blood concentrations will be set according to a pre-determined schedule and all~     measurements will be made prior to the start of surgery.~      Prospective validation of the Covariates Model will be done by comparing blood concentration~     of propofol predicted by the model to those actually measured. These results will then be~     compared to the predictions made using the models in current clinical practice.~      Modelling of the effect site means predicting the concentration of propofol in the brain for~     a given blood concentration. This will involve using depth of anaesthesia monitors (such as~     bispectral index) as surrogate markers of brain concentration and comparing this to the~     predicted and measured blood concentrations of propofol.~      Finally, important information on the distribution and clearance of propofol can be gained~     through the comparison of venous and arterial blood samples. In this study, simultaneous~     sampling of venous and arterial blood will facilitate this comparison.~   "
119425|NCT01492699|"~     This is a clinical study for adult subjects with Post Traumatic Stress Disorder.~   "
119426|NCT01492686|"~     The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via~     intravenous drip infusion once a day in the patients with ALS based on the changes in the~     revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in~     double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186~     to the ALS patients.~   "
119427|NCT01492673|"~     The purpose of this study is to find out what effects, good and/or bad treatment with a new~     combination of drugs, cyclophosphamide, topotecan, and bevacizumab has on the patient and~     their cancer.~      The medications, cyclophosphamide and topotecan, are standard drugs often used together for~     the treatment of cancer in children with either Ewing's sarcoma or neuroblastoma.~      Bevacizumab is an experimental drug called an antibody that targets a protein important in~     the growth of cancer cells called vascular endothelial growth factor (VEGF). VEGF is made by~     tumor and other surrounding cells to help make blood vessels needed for the growth and~     spread of cancer cells in the body. The way that bevacizumab works is to stop the cancer~     cells from making their own blood supply, causing the tumor to stop growing bigger or from~     spreading. In adult clinical trials, bevacizumab has shown promising anti-cancer activity in~     patients with cancer of the colon/rectum (colorectal) and breast. It has been approved by~     the Food and Drug Administration (FDA) for use in patients with colorectal cancer but not in~     cancers found in children. Bevacizumab has been tested in early clinical studies in children~     and has been shown to be safe.~      Other goals of this study will include research tests designed to test the following changes~     in the patient or their cancer: to see how the body handles and breaks down bevacizumab~     (pharmacokinetics), to look at changes in proteins in the blood that may affect the way the~     cancer responds to the combination (angiogenic profile, angiogenesis associated serum~     biomarkers), to look at changes in genes that may affect how the cancer responds to~     treatment with this combination of medications (metabolic signature), and to monitor the~     effects of changes in the way the body grows and develops before and after bevacizumab is~     given.~   "
119428|NCT01492660|"~     Patients scheduled for total knee replacements and suitable for sciatic nerve block will be~     randomized to one of 2 groups.~      Group 1 will have the nerve block performed using a standard Pajunk block needle under~     ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement~     also guided by electrical nerve stimulation. Group 2 will have the block performed using a~     Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound~     (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for~     catheter location.~      An observer blinded to the needle type will assess the quality of needle visualisation on a~     recording of the US image taken during the procedure, along with adequacy of spread of local~     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be~     block success rate, block performance time, complication rate, number of needle passes per~     block, and adequacy of spread of local anesthetic.~   "
119429|NCT01492647|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA~     after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese~     participants with acne.~   "
119430|NCT01492634|"~     Title of study: Optimizing Fluid Status~      Study code: HD-IIT-01-E~      Study design: Prospective open design in study centre at two locations~      Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload~     and dry weight~      Aim of the study: To improve the fluid status in chronic HD patients (measured as OH~     (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to~     now, the BCM was occasionally applied in both locations of the study centre.~      Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry~     weight (post-weight plan)will have significant consequences, namely a decrease of the:~        -  time averaged fluid overload (TAFO),~        -  proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)~        -  proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),~        -  mean overhydration,~        -  variance of overhydration,~        -  time outside the reference range (-1.0L < OH < 2.5L).~      Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM,~     Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ;~     Body Composition Monitor BCM ; Data management software / database system NephroLink~     Disposables used in this study: BVM blood lines and BCM electrodes~      Patients: 60 patients~   "
119431|NCT01492621|"~     Subjects with major depression will be evaluated and intensively characterized through~     questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic~     resonance imaging will be used to document baseline white matter structure. subjects will~     then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks~     the evaluations will be repeated.~   "
119432|NCT01492608|"~     The purpose of the study is to assess whether magnesium sulphate for women at risk of~     preterm birth can protect their children against cerebral palsy. The results from this~     randomised controlled trial will be added to the previous meta-analysis to obtain firm~     evidence for magnesium sulphate as a neuroprotector, and determine whether it should be used~     as standard therapy for women in preterm birth.~   "
119438|NCT01492530|"~     The MAALES Project is a community collaborative intervention designed to prevent HIV~     infection and transmission among African American men who have sex with both men and women.~     The investigators are a collaboration of researchers, community service providers and~     activists who are committed to developing and testing effective HIV prevention interventions~     that employ holistic and culturally relevant approaches. This includes recognizing the~     impact of forces such as racism, homophobia, heterosexism, sexism, and gender expectations~     on individual behavior and relationship dynamics in African American communities.~   "
119439|NCT01492517|"~     Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects~     between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate~     asthmatics.~      Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to~     50 healthy adults to participate in this study.~      Procedures (methods): Subjects will be exposed to clean air, to 300 µg/m3 of diesel exhaust~     for 2 hours and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled~     environment chamber. Primary endpoints will include spirometry and lung cell changes~     post-exposure. Secondary endpoints will include analysis of blood clotting/coagulation~     factors, Holter monitoring of cardiac parameters, analysis of soluble factors present in~     plasma and bronchial lavage and analysis of intracellular factors present in lung tissue~     obtained from a brush biopsy.~   "
119440|NCT01492504|"~     The primary purpose of this study is to determine whether the hepatitis C virus continues to~     remain unable to be detected in subjects who were previously treated with Asunaprevir~     (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.~   "
119441|NCT01492491|"~     The purpose of this study is to evaluate the serum concentrations of antoxidant vitamines A,~     C, E, inflammatory cytokines and middle-large toxins in patients treated with online~     hemodiafiltration, standard HFR and SUPRA-HFR.~   "
119442|NCT01492478|"~     The aim of this study is to do an evaluation of the clinical profile of depression in HCV~     patients (newly diagnosed and treatment naïve), and in these same individuals, 24 weeks~     after the beginning of IFN+Ribavirin therapeutics (n=100). To characterize depression~     associated to HCV with and without interferon (IFN), the investigators will use clinical,~     behavioral, biochemical and genetic markers, and to distinguish their different~     symptomatologic dimensions.~      The control group will be composed by 100 individuals with Major Depression diagnosis, and~     not from the general population, because the investigators are not trying to study the~     incidence of depression in general population, but to characterize the clinical profile of~     patients with HCV (IFN+Ribavirin) compared to major depression.~      Thus, the investigators will total 300 evaluations in 200 individuals, 100 from each group,~     and considering that the clinical group will be evaluated before the therapeutics and~     re-evaluated 24 weeks after its beginning.~      Hypotheses~        1. Depression in individuals affected by HCV is associated to genetic vulnerability.~        2. Genetic vulnerability increases the risk of depression when IFN therapeutics is used.~        3. Depression associated to infection by HCV presents a symptomatological profile that is~          different from general depression, which is maintained with IFN therapeutics.~        4. A higher state of depression in the beginning of a treatment, if not treated, is a risk~          factor to abandoning therapeutics.~        5. When comparing genders, women present a more severe symptomatological profile than men.~   "
119443|NCT01492465|"~     The purpose of this study is to determine whether AMG 876 is safe and well tolerated in~     subjects with type 2 diabetes.~   "
119444|NCT01492452|"~     This is a randomized clinical trial. The population consisted of parents of children~     undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over~     18 years, and the following were considered exclusion criteria: inability to understand~     and/or answer the questions for any reason, parents of children undergoing surgery for~     insertion of the pacemaker and defibrillator, surgical death and not take up the case. 22~     parents in the intervention group were randomized and received standardized guidelines for~     nursing and 22 parents participated in the control group received the guidelines and routine~     of the institution. Anxiety was assessed using the STAI State-Trait Inventory in the~     preoperative period and 48 hours after surgery the child.~   "
119445|NCT01492439|"~     The purpose of this study is to determine whether cognitive remediation as an adjunct to~     supported education, will result in improved cognitive functioning, symptoms, and~     performance in academic domains for persons with psychosis compared to supported education~     given alone.~   "
119446|NCT01492426|"~     The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and~     Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b~     patients~   "
119447|NCT01492413|"~     This study was designed to test the impact of a 12-week online behavioral modification~     program for weight loss, with or without a fortified beverage. Subjects are randomized to~     four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling~     (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12~     weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after~     12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3)~     after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.~   "
119448|NCT01492400|"~     This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal~     implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular~     edema (DME).~   "
119449|NCT01492387|"~     The purpose of the study is to assess the efficacy of an individualized approach to duration~     of antibiotic therapy based on each subject's clinical response compared to a local standard~     approach in patients coming from the community and who are hospitalized because of a~     pneumonia.~   "
119450|NCT01492374|"~     The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027~     on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and~     computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly~     intravenous (IV) infusions of BMS-241027~   "
119451|NCT01492361|"~     AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic~     acid (EPA) being developed by Amarin Pharma Inc. for the treatment of hypertriglyceridemia.~     The purpose of this study is to evaluate whether this drug, combined with a statin therapy,~     will be superior to the statin therapy alone, when used as a prevention in reducing~     long-term cardiovascular events in high-risk patients with mixed dyslipidemia.~   "
119452|NCT01492348|"~     The overall objective of this study is to test the effectiveness of a systems-level approach~     to primary care recognition and management of PTSD and depression in the military health~     system. More specifically, the investigators will test the effectiveness of a telephone care~     management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD~     Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC).~      Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who~     are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and~     depression symptom severity compared to participants assigned to OUC over 12-months of~     follow-up.~      Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who~     are randomly assigned to STEPS UP will report significantly greater improvements in somatic~     symptom severity, alcohol use, mental health functioning, and work functioning compared to~     participants assigned to OUC over 12-months of follow-up.~      Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to~     OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in~     terms of dollars per quality adjusted life years saved.~      Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians,~     care managers, and family members will report that STEPS UP is acceptable, effective,~     satisfying, and appropriate PTSD and depression care.~   "
119453|NCT01492335|"~     Most primary care physicians do not screen older patients for cognitive impairment.~     Identification of cognitive impairment may result in earlier referral for diagnostic work-up~     and earlier treatment and better patient outcomes. The purpose of this study is to determine~     whether physicians who receive the results of a cognitive screen use this information in~     treatment plans and whether this results in better cognitive outcomes for the older~     patients.~   "
119454|NCT01492322|"~     A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is~     available at the synapse and this may affect the underlying reasons for relapse in smokers.~     This research will use Single-photon emission computed tomography SPECT and the DAT-specific~     ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT~     in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours~     without smoking) conditions.~   "
119455|NCT01492309|"~     The purpose of this study is to determine if repetitive transcranial magnetic stimulation~     (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.~      TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more~     effectively with one another. Effective neuron communication is thought to lead to the~     lessening of depressive symptoms. In this study subjects require daily TMS treatment for~     approximately four weeks.~   "
119456|NCT01492296|"~     Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty~     stomach is required to ensure quality and safety. For this reason, endoscopy is~     conventionally performed after 8 or more hours of fasting, which is potentially related to~     discomfort to the patients. In recent studies, surgical cholecystectomy has been described~     to be safe after two hours of fasting on liquids. The aim of this study is to assess safety,~     quality and comfort of upper GI endoscopy after two hours of fasting.~   "
119457|NCT01492283|"~     The main objective of this study is to analyze the pathophysiological implications of~     glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver~     disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The~     present study will contribute significantly to the understanding of the pathophysiology of~     liver disease and glucose metabolism. The final goal is that the results could pave the way~     for new treatment modalities for patients with liver disease.~   "
119458|NCT01492270|"~     The incidence of prostate cancer is rising however the number of deaths from prostate cancer~     is stable. Meaning the investigators are diagnosing many men with prostate cancer that will~     not impact on their life. The rise in incidence is mainly due to increased use of the blood~     test Prostate Specific Antigen (PSA), as a screening test.~      Currently men suspected of having prostate cancer, identified by a raised PSA undergo~     trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test~     unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as~     it is random and performed blind-the operator does not know where the cancer is. Thus many~     low-risk cancers that do not need treating are diagnosed and many high risk cancers are~     missed or incorrectly classified. So, men with a negative biopsy or those with low risk~     disease are usually advised to undergo another TRUS biopsy.~      An imaging test is needed that could help men and their doctors decide whether the biopsy is~     a true reflection of what is inside his prostate.~      The investigators will test the role of two imaging tests. The first, multi-parametric~     magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The~     second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the~     results of these tests with a detailed biopsy map-transperineal template prostate mapping~     biopsy (which is currently the best way to find out what is in the prostate but requires~     multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone~     one or more TRUS biopsies and who have been advised to have further tests on as part of~     standard of care. They will be recruited from UCLH referral letters and clinics.~      The investigators aim is to see if either of these tests can confidently rule out the~     presence of clinically important disease.~   "
119459|NCT01492257|"~     Total joint arthroplasty (TJA) is an effective procedure for reducing pain and improving~     function in patients with disabling osteoarthritis (OA) of the hip or knee. However, as with~     all invasive procedures, TJA is associated with certain risks and substantial costs. Since~     the indications for TJA are heavily dependent on patients' quality of life and expectations.~     TJA utilization rates vary widely throughout the United States, as seen with other~     'preference-sensitive' procedures. Early evidence suggests shared decision making (SDM)~     strategies are effective in enhancing patient decision quality, or the degree to which~     treatment decisions reflect the preferences of fully informed patients, especially for~     preference-sensitive procedures like TJA. Despite these advantages, however, SDM has not~     been embraced or widely adopted in orthopaedics. To investigate this limited uptake, the~     investigators propose a series of evaluations of individual-level strategies. The~     investigators innovative and unique contribution is to approach patients, surgeons and~     healthcare purchasers as having symmetric and equally valid concerns about the benefits and~     cost associated with SDM. The investigators overall objective is to facilitate wider~     dissemination of SDM strategies in orthopaedic practices. The specific aims of the project~     are to assess, for SDM strategies, the impact on key patient, surgeon, and healthcare~     purchaser priorities; By achieving this aim our project will produce new interventions and~     incentives for disseminating SDM that are endorsed as feasible and acceptable by a coalition~     of patients, surgeons, and purchasers. The investigators plans for evaluation include a~     randomized controlled trial to evaluate the impact of SDM on outcomes of interest to~     patients, surgeons, and purchasers.~   "
119460|NCT01492244|"~     Blank has designed a medical diagnostic system in the form of an unvalidated online~     questionnaire and drawing tool used to describe and identify the location of knee pain,~     respectively. A component of the survey includes the patient inputting their diagnosis as~     the etiology of their knee pain. Dr. Ivo Dinov's team has used the data from 100,000 patient~     surveys to construct a probabilistic model to diagnose those who fill out the questionnaire~     and knee pain map but do not have a diagnosis. However, the validity of the online survey~     and the accuracy of the probabilistic model has not been confirmed in patients with known~     diagnoses. Therefore, the purpose of this study will be to recruit patients with knee pain~     at UCLA orthopedic clinics to complete the online survey which will then be applied to the~     probabilistic model to output possible diagnoses. The results will be compared to the actual~     diagnosis assigned to that patient in the clinic. If validated, the online survey may serve~     as a tool for diagnostic and research purposes.~   "
119461|NCT01492231|"~     The main purpose of the protocol is to collect and evaluate performance data after patients~     undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive~     Digestive Disease Center (CDDC).~   "
119462|NCT01492218|"~     This study is conducted in Asia. The aim of this study is to assess patient satisfaction~     after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as~     treatment for diabetes mellitus under normal clinical practice setting.~   "
119463|NCT01492205|"~     This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance~     of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital~     environment.~   "
119464|NCT01492192|"~     The goal of this clinical research study is to look at 2 new methods of scanning and see~     whether they can help researchers predict which tumours will respond to drugs that attack~     tumour blood supply.~   "
119465|NCT01492179|"~     Local anesthetics (LA) are increasingly used for postoperative pain management.~     Speicifically, several studies have found benefit of LA injected intra-abdominally following~     abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to~     local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The~     aim of this study is to assess whether lidocaine administered intravenously has similar~     analgesic efficacy as the same dose administered intra-abdominally in patients undergoing~     abdominal hysterectomy. All patients would have rescue analgesia using the patient~     controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management~     during 24 h.~   "
119466|NCT01492166|"~     This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and~     convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral~     hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient~     setting.~   "
119467|NCT01492153|"~     This study is conducted in Asia. The aim of this study is to investigate the safety and~     efficacy of NovoLet® human insulin delivery system in an outpatient setting.~   "
119468|NCT01492140|"~     The purpose of this study is to characterize the safety and performance in normal~     therapeutic use of the Artiste System in comparison to standard manual administration of~     dermal fillers. Subjects are recruited from the investigator's practice and randomized to~     receive treatment with the Artiste System on either the left or right nasolabial fold, the~     contralateral fold to be treated with standard manual injections. Treatments occur in a~     single session to achieve optimal cosmetic results (OCR) balanced on both sides.~     Investigators are encouraged to use a variety of types and brands of dermal fillers,~     recruiting subjects for the study as necessary. Safety and performance evaluations will be~     made through a combination of clinical observations, questionnaires for the subject and for~     the Treating Investigator, and spontaneous reports of adverse events. There are 6 required~     study visits: Screening, Day 1 (Treatment Day), Day 3, Day 8, Day 15, and Day 29.~   "
119469|NCT01492127|"~     This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of~     hepatocellular carcinoma (HCC) by studying their variation following curative treatment of~     HCC. The hypothesis of the study is that plasma proteasome levels will decrease following~     curative treatment, and that proteasome levels could be used as a marker to detect early~     recurrence.~   "
119470|NCT01492114|"~     This research will investigate the hypothesis that resveratrol when given orally to healthy~     adult smokers induces a decrease in the inflammatory and oxidative mediators which~     characterize the low-grade systemic inflammatory state and the oxidants-antioxidants~     imbalance of tobacco users.~   "
119471|NCT01492101|"~     The study is designed as an open-label, randomized, parallel, two arm, multicenter,~     international Phase 3 study in patients with recurrent or metastatic breast cancer~     previously treated with cytotoxic chemotherapy regimens.~      The primary study objective is to compare overall survival of patients who receive NKTR-102~     given once every 21 days to patients who receive treatment of Physician's Choice selected~     from a list of seven single-agent intravenous therapies.~   "
119472|NCT01492088|"~     This is a phase 1/2, open-label, single-agent, multi-center, dose-escalation study of~     brentuximab vedotin in pediatric patients with relapsed or refractory systemic anaplastic~     large-cell lymphoma or Hodgkin lymphoma~   "
119473|NCT01492075|"~     The investigators hypothesis is that patient controlled local anesthetics administered~     intraabdominally are more efficacious compared to continuous infusion in reducing~     postoperative pain and morphine consumption.~   "
119474|NCT01492062|"~     You are invited to participate in a research study for the development of an artificial~     pancreas. An artificial pancreas uses a program which takes information from a continuous~     blood glucose monitor and uses that information to tell an insulin infusion pump how much~     insulin to deliver. The primary purpose of this study is to gain experience with insulin~     delivery algorithms or programs program (algorithm) provides the best regulation of glucose~     levels so that there are no severe low blood glucose reactions and blood glucose levels are~     generally between 70 to 180 mg/dl.~   "
119475|NCT01492049|"~     The goal of this study is to test patient education program for decision making about~     colorectal cancer (CRC) screening in community health centers.~   "
119784|NCT01488019|"~     This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term~     safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary~     Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of~     double-blind treatment.~   "
119476|NCT01492036|"~     The goal of this clinical research study is to collect information about the long-term~     safety of gene transfer therapy. This study is also designed to create a database of medical~     information about patients who have received gene transfer therapy, in order for researchers~     to track and review the long-term safety and any effects (good or bad) of gene transfer~     therapy.~   "
119477|NCT01492023|"~     The purpose of this study is to determine whether neuropsychological rehabilitation focused~     on attention retraining and teaching compensatory strategies has positive effects on~     cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients~     with MS. The hypothesis is that the neuropsychological intervention shows positive effects~     on cognitive performance, QoL and perceived cognitive deficits.~   "
119478|NCT01492010|"~     Muscle mass is normally maintained through the regulated balance between the processes of~     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old~     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase~     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids~     are ones that must be consumed through food, while non-essential amino acids can be made by~     our body. Interestingly, the essential amino acids are all that are required to increase the~     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to~     be particularly important in regulating protein synthesis. However, how leucine is able to~     increase protein synthesis is not entirely understood. Previously, it has been shown that~     20-25 g of high-quality protein, such as that found in milk, appears to be the amount of~     protein that maximizes the rate of muscle protein synthesis after performing a bout of~     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after~     ingesting the following:~        1. 25g whey protein~        2. 6.25g whey protein supplemented with leucine~        3. 6.25g whey protein supplemented with essential amino acids but no leucine~      Thus, we will measure muscle protein synthesis after consumption of the above beverages in a~     leg that has done no exercise ( ie. a rested leg) and in the other leg that has done~     resistance exercise. We hypothesize that 6.25g whey supplemented with leucine will stimulate~     muscle protein synthesis as effectively as 25g whey, but that 6.25g whey supplemented will~     all the essential amino acids except whey will be less effective at increasing muscle~     protein synthesis. Whey protein is a dairy based protein found in cow's milk, thus when you~     drink a glass of milk you are consuming some whey protein. However we are using an isolated~     form of whey protein, meaning it has been removed from milk. As mentioned previously, amino~     acids are 'strung-together' to make protein. The 'essential' amino acids must be consumed~     through food because our body cannot make them, thus they are consumed when you eat protein~     rich foods like milk or chicken.~   "
119479|NCT01491997|"~     Stress has been linked to chronic health problems, particularly diseases involving~     inflammation-mediated tissue injury and organ failure. Accordingly, it is not surprising~     that mind/body interventions are advocated for treatment of chronic inflammatory diseases.~     One such candidate disease is ulcerative colitis (UC) because: (1) UC is a life-long,~     relapsing, disabling inflammatory disorder of the intestine that lacks a non-toxic,~     efficacious treatment; (2) the therapeutic goal is to improve quality of life by~     ameliorating disabling symptoms and preventing disease progression by preventing disease~     flare-up, (3) stress triggers UC flare-up by modifying intestinal function and inflammatory~     processes, highlighting the potential therapeutic benefit of reducing physiological stress~     responses. The purpose of this study is to see if either of two 8-week mind/body medicine~     courses has an effect in reducing stress and affecting the course and severity of UC. Both~     have been shown to benefit other aspects of health and well-being.~   "
119480|NCT01491984|"~     A laryngoscope is a medical instrument that is used to get a view of the voice box and the~     space in between the vocal cords. A laryngoscope is used to place a breathing tube into the~     trachea (windpipe or airway) to protect the patient's airway and provide a way to help a~     person breathe during surgery; this is called intubation.~   "
119481|NCT01491971|"~     Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients~     with Prostate Cancer.~   "
119482|NCT01491958|"~     Phase II trial evaluating the safety & efficacy of Atorvastatin for prophylaxis of Acute~     Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human~     leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).~   "
119483|NCT01491945|"~     The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is~     safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.~   "
119484|NCT01491932|"~     This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients~     who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias~     (PD-LID).~   "
119485|NCT01491919|"~     The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment~     of high blood pressure, heart failure, and acute heart attacks in adult patients. In~     children over 6 years of age, lisinopril is approved for the treatment of high blood~     pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme~     inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals~     that tighten the blood vessels so blood flows more smoothly and the heart can pump blood~     more efficiently.~      There is some information available about how children with high blood pressure absorb,~     distribute, metabolize, and eliminate lisinopril (this information about medication~     processing by the body is called pharmacokinetic data). However, there is no information~     about how children with high blood pressure who have received a kidney transplant process~     lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril~     may help kidney transplants work longer by reducing the activity of chemicals made by cells~     in kidney transplants that can lead to inflammation and injury. Such benefits have not been~     found with another group of blood pressure medications called calcium channel blockers,~     which are the most commonly used medication group to control high blood pressure in children~     after a kidney transplant. A clinical trial will be conducted in the future to compare which~     medication group helps kidney transplants in children last longer. To guide the selection of~     the best dose to test in future studies, investigators in this study will try to determine~     the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and~     adolescents (2-17 years of age) who have received a kidney transplant and have high blood~     pressure.~   "
119486|NCT01491906|"~     The purpose of this study is to test the effect of a mobile phone-assisted lifestyle~     intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared~     to a control group.~   "
119487|NCT01491893|"~     Purpose of the Study:~      To determine the maximally tolerated dose (MTD) or optimal dose of PVSRIPO when delivered~     intracerebrally by convection-enhanced delivery (CED). To obtain correlative mechanistic~     evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors and to~     estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO Grade IV~     malignant glioma patients. To obtain information about clinical response rates to~     intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the~     optimal dose.~   "
121129|NCT01470443|"~     The objective of the trial is to compare Progression free survival between GEMOX~     (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable~     Biliary tract carcinoma patients.~   "
119488|NCT01491880|"~     This pilot study will examine the feasibility of two modes of service delivery (e.g., a~     minimal therapist contact, self-help program, and a more intensive therapist supported,~     telephone-based approach) in a rural, primarily Latino, population. These modes of delivery~     may ultimately improve access to evidence based treatments and mental health outcomes among~     underserved groups.~   "
119489|NCT01491867|"~     Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide~     more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann~     applanation tonometry (GAT.~   "
119490|NCT01491854|"~     This study is performed as part of the Marketing Authorisation Holder's post-marketing~     pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic~     potential and immunogenicity of rhGH therapy in short children born small for gestational~     age (SGA).~   "
119491|NCT01491841|"~     Part 1: This is a phase I trial of the combination of bendamustine, rituximab and pixantrone~     in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will~     be used to determine the maximum tolerated dose (MTD) of the combination. A static dose of~     bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each~     cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in~     sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be~     determined based on DLTs that occur during the first 2 cycles of the drug combination.~      After 2 cycles of study drug, all subjects achieving stable disease or better may continue~     on study for up to 6 cycles. However, adverse events occurring during cycles 3-6 will not be~     considered DLTs and will not contribute to the determination of the MTD.~      Part 2: After the MTD is determined an expansion study is planned. This will be a phase II,~     prospective, open label, single arm study of combination therapy with bendamustine,~     rituximab, and pixantrone at the defined MTD schedule based on the phase I portion of this~     study. Subjects enrolled in part 2 of the study must have an aggressive, relapsed or~     refractory B-cell NHL, to include follicular lymphoma (FL) grade 3, Diffuse Large B Cell~     Lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), and other aggressive~     histologies. We anticipate the total sample size to be 36 patients accrued at a rate of 2~     patients per month. Restaging will be employed after cycle 2, and if the patient has stable~     disease or better they may continue on study for up to 6 cycles.~   "
119492|NCT01491828|"~     This study will validate whether an external vibratory stimulus applied to a subject's neck~     causes head, neck or jaw movement.~   "
119493|NCT01491815|"~     This is an international (Nordic) trial designed to compare the safety and efficacy of~     active conventional therapy (ACT) and three biologic treatments in subjects with early~     rheumatoid arthritis (RA). The global aim of this study is to assess and compare~        1. the proportion of subjects who achieve remission with ACT versus three different~          biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab)~        2. two alternative de-escalation strategies in patients who respond to first-line therapy.~   "
119494|NCT01491802|"~     Preliminary information from our laboratory indicated that even patients with milder chronic~     obstructive pulmonary disease (COPD) can have significant physiological derangements which~     become more pronounced during exercise, leading to intolerable dyspnea at lower levels of~     ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea~     and activity limitation in GOLD stage II COPD and will determine if there is a sound~     physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting~     muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA~     alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation.~     Objectives of this study are to determine if: 1) neuromechanical uncoupling of the~     respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with~     LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving~     neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to~     excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of~     central respiratory neural drive to tidal volume displacement, a measure of neuromechanical~     uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise~     endurance, which will be explained by partial reversal of the above mechanical~     abnormalities. The investigators will conduct a randomized, double-blind crossover study and~     compare the effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise~     endurance and ventilatory mechanics in GOLD stage II COPD.~   "
119495|NCT01491789|"~     The research is being done to look at the benefits of a recreational and therapeutic program~     for people with spinal cord injury using the VSail-Access sailing simulator.~   "
119496|NCT01491776|"~     The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to~     accurately test a throat swab specimen from a symptomatic patient for the presence or~     absence of Group A Streptococcus (Strep A) when compared to culture.~   "
119497|NCT01491763|"~     20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the~     Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy~     followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic~     treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and~     probability of long-term survival less than 20%). The effectiveness of imatinib for~     hematologic responses in patients with Ph + (observed in phase I and II) led to its use in~     phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC~     above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged~     follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly~     higher than historical controls with the same chemotherapy without imatinib. This led to the~     approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for~     Ph + in combination with chemotherapy.~      Of the studies that led to the approval of this indication for imatinib, and other incurred~     after, the following conclusions can be drawn:~      There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and~     chemotherapy. However, when compared with concomitant alternating with the first achieved a~     higher rate of RM at the end of induction, although this did not influence DFS.~      In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only~     imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to~     achieve CR in young patients with minimal toxicity, which further compromises the~     administration of treatment and allow for an allogeneic HSCT with minimal toxic load~     possible.~      Although there is no consensus on the indication of allogeneic HSCT in first CR when given~     imatinib associated with intensive chemotherapy is an option that is done in most studies.~      The allogeneic HSCT is most effective when carried out in complete molecular response to or~     greater than when there is more residual disease. However, the impact of MRI to obtain early~     (after induction) on survival is not clear. So far-reaching goal is to make the TPH in~     complete molecular response situation or greater.~      The relapse of the disease at the molecular level is still short-term (less than 3 months)~     of hematological relapse. This implies the need for frequent monitoring of residual disease~     (ER) The frequency of relapse post HSCT is high (around 30%), raising the need for any post~     HSCT treatment, including imatinib included. Are currently ongoing clinical trials comparing~     the systematic administration of imatinib after administration TPH face is detected only~     when ER.~      The applicability of the administration of imatinib after HSCT is limited by toxicity~     related to the procedure of TPH, is making frequent dose reduction or discontinuation.~      Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical~     trial is to get as many molecular responses before allogeneic HSCT in a position to make the~     same MRI complete or greater. After TPH, must be very close monitoring of the ER, and~     imatinib is administered as soon as you notice the loss of molecular response.~      In patients who can not make an allogeneic HSCT for lack of histocompatible donor or~     contraindications for its realization it is recommended imatinib and chemotherapy, although~     there are studies that have undergone an autologous HSCT, followed or not treatment~     maintenance with imatinib. The low toxicity of autologous HSCT and no effect of graft~     versus leukemia are strongly recommended the administration of maintenance therapy with~     imatinib combined with chemotherapy or not.~   "
119498|NCT01491750|"~     The purpose of this mixed methods pilot study is to produce preliminary data for a~     randomized, placebo-controlled trial testing a biobehavioral model of the effects of guided~     imagery on outcomes of total knee replacement surgery.~   "
119499|NCT01491737|"~     This randomized, open-label, 2-arm, multi-center, phase II study will evaluate the efficacy~     and safety of pertuzumab in combination with trastuzumab (Herceptin) plus an aromatase~     inhibitor in first-line patients with HER2-positive and hormone receptor-positive advanced~     breast cancer. Patients will be randomized to one of two treatment arms: Arm 1: pertuzumab~     plus trastuzumab plus aromatase inhibitor, Arm 2: trastuzumab plus aromatase inhibitor. At~     the investigator's discretion, patients may also receive induction chemotherapy (a taxane,~     either docetaxel or paclitaxel). The anticipated time on study treatment is until disease~     progression or unacceptable toxicity.~   "
119500|NCT01491724|"~     The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation~     in Gastric Intestinal Metaplasia (GIM)~      Objective:~      The aim of this study is to evaluate the learning curve of pCLE images interpretation in~     GIM.~      Research design:~      Blinded review of pCLE images for the diagnosis of GIM~      Sample size:~      Five beginner endoscopists will be assigned in this study to read approximately 80~     videoclips~      Data analysis:~      ROC curve is analyzed by SPSS version 16.~      Expected Benefit and Clinical Application Information on the learning curve for GIM~     interpretation from pCLE images in order to develop early gastric cancer detection~   "
119501|NCT01491711|"~     Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being~     the most common skin cancer with around 44,000 new tumours per year, and its incidence is~     still rising. In the past it has been a disease of the elderly patient but as a consequence~     of recreational sun exposure and tanning beds, more young patients develop a skin cancer as~     well. There are different subtypes of BCC and most subtypes are treated by surgical~     excision. Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common~     practice to treat superficial BCC (sBCC). Because of these techniques treatment by surgical~     excision can be avoided with the possibility of complications and scar formation. Both~     5-aminolevulino acid (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be~     used as a precursor of the photosensitiser. These agents generate an excess of~     protoporphyrin IX in metabolic active cells, which are illuminated by a specific light~     source leading to release of reactive oxygen radicals in tissue. The result is apoptosis and~     necrosis of tumour cells. At the moment, two treatment protocols are used in the~     Netherlands: the fractionated 5-ALA 20% (Fagron) protocol according to de Haas and the MAL~     (Metvix, Galderma) protocol. Because MAL was first marketed and registered as a treatment~     option for premalignant and superficial malignancies most hospitals in the Netherlands use~     this topical agent. However, there is no evidence which of the 2 agents is more~     (cost-)effective and/ or preferred by patients.~      Objective: to determine which treatment is the most effective treatment in terms of~     prevention of treatment failure, cost saving and patients preference when comparing~     fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.~   "
119502|NCT01491698|"~     This study is being done to learn more about how different surgery procedures bring back the~     eating pathway after removing the stomach in patients with stomach cancer. If the surgeon~     has decided that some, or all, of the patient's stomach must be removed the surgeon must~     create a new way to allow food to travel from the mouth to the intestines. Some patients~     develop problems because they are missing their stomach, such as lack of hunger, bloating,~     cramping, and heartburn.~      The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine~     if a change in surgery can help reduce these symptoms.~      The most common method of creating a way for food is called a Roux-en-Y, in which one part~     of the intestine is connected with the end of the esophagus (the swallowing tube) in the~     abdomen, and another connection is made between the intestines lower down.~      The change in surgery involves creating a pouch from a part of the intestines to replace the~     stomach.~      This study will compare the effects, good and/or bad, of gastric pouch reconstruction with~     the usual reconstruction to see if the pouch makes you feel better overall.~      This type of surgery has been used by some surgeons for many years and is known to be safe,~     but it is not known if it reduces symptoms or improves nutrition compared with the usual~     surgery.~   "
119503|NCT01491685|"~     This is an observational study comparing microcirculation of pregnant to non-pregnant women.~     Microcirculation means blood flow to the extremely small blood vessels in one's body.~     During pregnancy the amount of blood in a woman's body increases. The body responds to this~     increase by pumping more blood through the heart and narrowing the size of blood vessels.~      There are many types of blood vessels that have different roles in the body. Larger blood~     vessels. Transport blood to and from body organs like the brain and liver. Small vessels~     (microcirculation)distributes blood to the organ tissues. The microcirculation can change~     blood flow and blood pressure. Microcirculation is involved in delivering oxygen and~     nutrients to your body, removing waste products, and regulating body temperature.~      The investigators current understanding of the microcirculation in pregnant women is~     limited. There is a device available that can measure microcirculation. It is known as~     Sidestream Dark Field (SDF) imaging. It is a special type of camera that captures pictures~     of the microcirculation. In this study the investigators will compare the microcirculation,~     as seen with SDF imaging, of pregnant women to non-pregnant women. By improving the~     investigators understanding of maternal microcirculation the investigators are adding to the~     knowledge of how the pregnant body works. The investigators hope to then translate this~     knowledge into further studies to improve maternal and fetal outcomes through prevention and~     treatment of maternal low blood pressure caused by spinal anesthesia.~   "
119504|NCT01491672|"~     This study will evaluate everolimus as second-line therapy in patients with metastatic renal~     cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based~     upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF~     therapy other than sunitinib.~   "
119505|NCT01491659|"~     It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side~     effects related to the use of antibiotics~   "
119506|NCT01491646|"~     Pulmonary hypertension (PH) is a condition in which high blood pressure develops in the~     lungs and right side of the heart. People with PH suffer from shortness of breath, chest~     pain, heart failure, heart rhythm problems, and fainting. PH is diagnosed using a test~     called a cardiac catheterization where blood pressure is measured directly using a tube~     placed in the right side of the heart and lung arteries. Because a cardiac catheterization~     is invasive, researchers are investigating ways to diagnose PH using imaging tests that are~     not invasive. The study will evaluate whether or not a magnetic resonance image (MRI) of the~     heart, and blood tests can detect PH.~   "
119507|NCT01491633|"~     Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug~     has been used in treatment for other types of cancer and information from other research~     studies suggests that dasatinib may help to stop squamous cell lung cancer from growing,~     especially in individuals whose tumor has a mutation in the DDR2 gene.~      Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic~     targets are needed. Several studies have examined dasatinib in NSCLC; these report~     significant toxicities, but also responses in patients found to harbor mutations in DDR2 or~     BRAF.~      An open-label phase II trial with dasatinib was carried out to determine the response rates~     in patients with SqCC who had previously failed standard chemotherapy and to correlate~     responses with patient genotype.~   "
119508|NCT01491620|"~     This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the~     treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).~   "
119955|NCT01485796|"~     The purpose of the study is to acquire additional data on safety and tolerability of~     recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune~     Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration.~   "
119509|NCT01491607|"~     The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of~     BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this~     study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.~      This study will be conducted in the United States (U.S.), in 200 healthy male and female~     volunteer subjects ages 18 to 65 years.~      The duration of study participation for each individual subject will be approximately 128~     days (4.25 months), including a screening period of approximately 28 days followed by 100~     days on study.~   "
119510|NCT01491594|"~     The purpose of this study is to study the effect of eltrombopag on chemotherapy induced~     thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood.~     Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.~   "
119511|NCT01491581|"~     The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar,~     specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium~     on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium~     and iron status, and on their cognitive performances.~   "
119512|NCT01491568|"~     The purpose of this study is to evaluate the feasibility of using the investigational~     implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating~     posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with~     symptomatic degenerative disc disease.~   "
119513|NCT01491555|"~     Researchers at Children's Hospital Boston Neurology Department invite children to~     participate in a new research study. Researchers are looking for boys ages 2 - 30 with~     Duchenne Muscular Dystrophy (DMD) and healthy boys ages 2 - 30 (without any nerve or muscle~     concerns) to serve as controls. The study is evaluating a new technique that will test nerve~     and muscle function. The testing is all pain free.~      Children participating in the study will come in for 10 visits over two years. Visits will~     take place every month at first, then less often for the remaining visits. The tests for the~     study itself take approximately 2hours. If participants are interested or would like to~     learn more about the study, please call Lavanya Madabusi at 617-919-3554 or~     Lavanya.Madabusi@childrens.harvard.edu. All inquiries will be kept strictly confidential.~   "
119514|NCT01491542|"~     The purpose of this pilot clinical trial is to evaluate the feasibility of using the~     investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON®~     Spinal System) as a method of facilitating spinal fusion in patients with symptomatic~     degenerative disc disease.~   "
119515|NCT01491529|"~     This study will assess the efficacy and safety of modified release AFQ056 in patients that~     have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)~   "
119516|NCT01491516|"~     The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™~     Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as~     a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in~     patients with symptomatic degenerative disc disease. The safety and effectiveness of the~     implant will be evaluated.~   "
119517|NCT01491503|"~     The purpose of this study is to evaluate the drug-drug interaction between montelukast~     sodium and levocetirizine dihydrochloride in healthy male volunteers.~   "
119518|NCT01491490|"~     Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics,~     but it is also particularly associated with weight gain and metabolic problems.~      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the~     efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined~     with the subjects existing treatment of olanzapine in subjects with weight gain attributable~     to olanzapine treatment for functional psychosis. This is the first study to determine~     whether the study medications have a positive benefit for subjects on their cholesterol~     levels, body weight and other metabolic parameters, as well as a potential augmentation of~     the anti-psychotic effect of olanzapine.~      This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot~     study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and~     placebo), with a treatment duration of 6 weeks as well as a baseline period of variable~     length and one week follow-up. The two treatment groups will be randomised equally.~      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years~     and above and be clinically diagnosed with functional psychosis and receiving olanzapine~     treatment for no more than 3 months with evidence of weight gain attributable to olanzapine~     treatment.~      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a~     baseline period. Subjects will also be assessed at Visit 2 for further weight gain during~     the baseline period. The baseline period is flexible in length to allow time for this weight~     gain to be achieved and also for the olanzapine dose to be stabilised. If eligible the~     subject will be randomised into the 6-week treatment phase. There are a total of 6 visits in~     the study.~   "
119519|NCT01491477|"~     The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™~     Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal~     fusion in patients with cervical symptomatic degenerative disc disease.~   "
119520|NCT01491464|"~     The purpose of this clinical trial is to assess the safety and effectiveness of the~     rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients~     with symptomatic degenerative disease.~   "
119521|NCT01491451|"~     The purpose of this pilot clinical trial is to evaluate the device design as a method of~     facilitating spinal fusion.~   "
119533|NCT01491295|"~     1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir~          1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance~          (LAM-R)~        2. Long-term adefovir add-on therapy was effective for viral suppression. However, the~          economic burden for such dual antiviral therapy is heavy because of infinite treatment.~        3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated~          potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive~          patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive~          treatment-naive patients.~        4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by~          LAM/ADV combination treatment in LAM-R CHB patients.~   "
119534|NCT01491282|"~     To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of~     human brown adipose tissue.~   "
119522|NCT01491438|"~     OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors~     (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the~     safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN:~     Randomized, open clinical trial in parallel groups, controlled with conventional treatment.~      SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous~     ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION:~     1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional~     treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those~     cases where there has been no complete healing in this period, patients will continue the~     same management protocol to get it. 2-Control group: Conventional treatment twice a week~     (days 1 and 4)for 12 weeks of treatment.~      Conventional treatment includes: Cleaning and debridement of the wound, the application of~     corresponding dressing, and using of antibiotic if necessary in each visit.~      STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude~     model and the adjusted model (for confounding variables)will be built. The healing time of~     ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the~     corresponding comparison using the log rank test.~   "
119523|NCT01491425|"~     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®~     Device using laparoscopic surgical technique as compared to an historical control group~     treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients~     with symptomatic degenerative disc disease.~   "
119524|NCT01491412|"~     This is an observational study describing the real-life antipsychotic treatment during the~     hospitalisation of the patients due to acute psychotic episode.~      In this NIS subject's data will be collected at one visit at the moment of discharge from~     the hospital.~      The results of the study would help to characterise the discrepancy between current clinical~     practice and treatment guidelines, indicating that atypical antipsychotics are preferable~     and should be used in monotherapy during acute psychotic episodes in subjects with~     schizophrenia. Available evidence have revealed a frequent use of first-generation~     antipsychotics, polypharmacy, intramuscular route of administration and use of atypical~     antipsychotics in doses lower than recommended in registered summary of product~     characteristics.~   "
119525|NCT01491399|"~     The purpose of this clinical trial is to assess the safety and effectiveness of the~     Investigational implant as compared to the Control implant in the treatment of patients with~     one level or two adjacent levels of cervical symptomatic degenerative disc disease.~   "
119526|NCT01491386|"~     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®~     device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic~     degenerative disc disease using an open surgical technique.~   "
119527|NCT01491373|"~     This study is designed to evaluate the feasibility of recombinant human bone morphogenetic~     protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE®~     ) for anterior lumbar interbody fusion in patients with degenerative disc disease.~   "
119528|NCT01491360|"~     A new minimally invasive procedure for treating presbyopia is being evaluated to determine~     if there is improvement in near and intermediate vision after treatment.~   "
119529|NCT01491347|"~     Alcohol dependence is accompanied by several neurological mechanisms involving neuronal~     plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF)~     synthesis.~      The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a~     greater extent in subjects who had remained abstinent at 6 months after withdrawal than in~     subjects who had relapse.~      To verify if the BDNF serum levels variation is linked to the way that abstinence is~     installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects~     at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its~     evolution in relation to alcohol consumption, and other clinical characteristics :~     depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or~     toxicity. Monitoring serum BDNF concentrations in link with other clinical data could help~     to characterize alcohol dependence profiles in clinical practice, help predict relapses, and~     assist in adjusting care to prevent difficulties in alcohol withdrawal.~   "
119530|NCT01491334|"~     The purpose of this study is to validate safety and effectiveness in assessment of the~     female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to~     detect early prolapse conditions and characterize the outcome of reconstructive surgery.~   "
119531|NCT01491321|"~     The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain~     intensity, functional status and quality of life of patients with chronic low back pain.~   "
119532|NCT01491308|"~     The rationale for perioperative red blood cell (RBC) transfusion is based on the observation~     that anemia is an independent risk factor for morbidity and mortality after cardiac~     operations. However, transfusions have been associated with high rates of morbidity and~     mortality in critically ill patients, and some recent studies have shown worse outcomes,~     including increased occurrence of renal failure and infection, as well as respiratory,~     cardiac, and neurological complications, in transfused compared with non transfused patients~     after cardiac surgery. On the basis of past clinical observations, some authors have~     suggested that hematocrit should be maintained at around 30% and hemoglobin concentration at~     10 g/dL. Recently, however, this hemoglobin threshold has been reconsidered because of~     recognized risks associated with transfusion and greater appreciation of the importance of~     individual physiological responses to anemia. In a comparative trial of 428 patients~     undergoing elective coronary artery bypass graft(CABG) surgery, Bracey et al reported that~     reducing the hemoglobin trigger to 8 g/dL did not adversely affect patient outcomes and~     resulted in lower costs. An important multicenter Canadian Study by Hebert et al that~     included a large number of critically ill patients revealed that A restrictive strategy of~     red-cell transfusion (hemoglobin concentration maintained between 7.0and 9.0g/dL) is at~     least as effective as and possibly superior to a liberal transfusion (hemoglobin~     concentration between 10 and 12 g/dL) strategy in critically ill patients, with the possible~     exception of patients with acute myocardial infarction and unstable angina, in terms of~     reducing organ dysfunction and mortality.~      The investigators would like to determine whether a restrictive strategy of red-cell~     transfusion and a liberal strategy produce equivalent results in orthopedic-oncology~     patients undergoing surgery.~   "
119535|NCT01491269|"~     The aim of the present study was to investigate if guided Internet-delivered~     Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously~     undergone a multidisciplinary treatment but still have residual problems.~   "
119536|NCT01491256|"~     Pre-treatment with statins decreased the incidence of cardiac enzyme increase after~     percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI~     myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment~     on post-procedural index of microcirculatory resistance (IMR) values that are introduced for~     assessing the status of the microcirculation.~   "
119537|NCT01491243|"~     Patients who undergo urgent/emergency coronary angiography can not receive any preventive~     treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil~     gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and~     effective treatment of contrast induced nephropathy in patients with urgent/emergency~     coronary angiography~   "
119538|NCT01491230|"~     Identifying the post-transplantation phase wherein neutrophils recover their ability to~     release NETs could shed new light on the mechanism responsible for the increased~     susceptibility to infection among these patients and aid in improving their prophylactic~     antimicrobial treatment. Therefore, we aim to examine neutrophil extracellular traps (NETs)~     formation, in relation to other neutrophil functions like chemotaxis, superoxide production,~     hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients~     undergoing autologous and allogeneic hematopoietic stem cell transplantation (HSCT).~   "
119539|NCT01491217|"~     The main objectives of this study are to determine the maximum tolerated dose (MTD) and~     recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of~     Oraxol® in Phase II.~   "
119540|NCT01491204|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral~     Paclitaxel. Eligible subjects of this study are patients with histologically or~     cytologically confirmed malignant solid tumor refractory to standard therapy.~      Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and~     Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started~     on day 29.~      Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of~     paclitaxel~   "
119541|NCT01491191|"~     Postsurgical pain becomes chronic when it lasts more then two months after surgery. A~     neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high~     rates after urologic and gynecologic surgeries.~      Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors~     release, without adverse events.~      The investigators assume that perioperative administration of PEA can reduce chronic~     postsurgical pain incidence of patients undergoing to urologic and gynecologic elective~     surgery.~   "
119542|NCT01491178|"~     To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients~     with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or~     systemic embolism (SEE).~   "
119543|NCT01491165|"~     Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are~     high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell~     with self-and directed differentiation capacity can effectively rescue experimental liver~     failure and contribute to liver regeneration, which suggests the feasibility of stem cell~     transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma~     stem cell transplantation through interventional procedures in patients liver cirrhosis will~     be evaluated.~   "
119544|NCT01491152|"~     Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day~     the investigators have treated children diagnosed cerebral palsy with side-alternating whole~     body vibration (System Galileo®) from the age of two years on. Considering verticalisation~     (standing and walking) at about 12 months of age in a normal developing child the~     investigators suggest the introduction of verticalisation with whole body vibration to a~     child with CP at this early age in order to enhance motor development and participation.~      In this pilot study the investigators will test the feasibility and the effect on motor~     development of whole body vibration in children with CP from 12 months of age. The~     investigators will investigate the effect of whole body vibration on motor performance,~     independence in all day living situations, quality of life and contractures compared to a~     control group.~   "
119545|NCT01491139|"~     The aim of this study is to find the safe dose and best dosing schedule of olaparib to give~     in combination with cisplatin based chemoradiotherapy (CRT) in patients with locally~     advanced head and neck cancer. The dose decided on in this part of the study will become the~     recommended dose for the randomised Phase II trial.~   "
119546|NCT01491126|"~     The investigators study aim is to determine whether there is a any advantage in starting~     with upper or lower endoscopy. The main study objective will be the amount of analgesia~     needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate~     of detection of significant pathologies, total time of procedure, examinee's tolerance, time~     to recovery and examinee's satisfaction.~   "
119547|NCT01491113|"~     This is a human pharmacology, single-dose study to investigate the pharmacokinetics of~     orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and~     in Japanese subjects with various degrees of impaired renal function.~   "
119548|NCT01491100|"~     Study assessing cognitive function and physical activity in people with relapsing remitting~     multiple sclerosis.~   "
119549|NCT01491087|"~     The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at~     2, 3, and 4 months of age in order to meet the regulatory requirements for the license~     renewal as for any other product registered in China, and to generate additional clinical~     data using the three-dose primary vaccination schedule in some other Chinese provinces.~      Primary Objective~        -  To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age~          in the study population.~   "
119550|NCT01491074|"~     Acute coronary syndromes (ACS) are still associated with high morbidity and mortality,~     despite several improvements in their management. This may indicate that important~     pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease~     mechanisms.~      Based upon previous research, the investigators believe that providing a block in the~     damaging inflammatory loop though short term inhibition of Interleukin-6 receptor~     signalling, could be an attractive therapeutic target in ACS; and of particular interest in~     patients with non-ST elevation myocardial infarction (NSTEMI), a disease often characterized~     by widespread coronary inflammation with multiple unstable plaques.~      The investigators hypothesize that a single administration of the anti-Interleukin 6~     receptor antagonist Tocilizumab, in patients with NSTEMI, may interrupt the~     self-perpetuating inflammatory loops which could improve plaque stability, with potential~     secondary beneficial effects on myocardial damage.~      This will be investigated in a randomized, double blind, placebo-controlled study, including~     a total of 120 patients.~   "
119551|NCT01491061|"~     It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7~     days can significantly reduce procedural myocardial injury in elective percutaneous coronary~     intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose~     ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage~     similarly to long-term pre-treatment with standard doses.~   "
119552|NCT01491048|"~     This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation~     in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor~     performance and testing the quality of life of patients undergoing THA surgery, to improve~     rehabilitation strategies for this population.~   "
119553|NCT01491035|"~     The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its~     metabolites in connection with multiple oral dosing in child and adolescent patients with a~     DSM-IV-TR diagnosis of Depressive or Anxiety Disorder~   "
119554|NCT01491022|"~     The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in~     Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple~     sclerosis. There are multiple studies to suggest that persons with multiple sclerosis~     benefit from this medication and have major improvements in gait after taking this~     medication. However, this medication was never studied in Parkinson's disease. This study~     aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).~   "
119555|NCT01491009|"~     The aim of the study was to compare the effects of remifentanil-dexmedetomidine and~     remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia~     care (MAC) patients undergoing cystoscopy.~   "
119556|NCT01490996|"~     Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable~     colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX)~     chemotherapy for up to 12 cycles(approximately 6 months) of treatment.~      Primary measurements focus on safety and tolerability. These will be recorded in real-time~     and report the number and severity of adverse events.~      Secondary measurements will include efficacy, (measured by response rate with RECIST and~     overall survival in months) supported by biomarker analysis.~   "
119557|NCT01490983|"~     This study is being conducted in a population of patients with chronic phase Chronic Myeloid~     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral~     cancer drugs.~   "
119558|NCT01490970|"~     Sarcoma Database~   "
119559|NCT01490957|"~     Functional Assessment of Cancer Therapy - Bone Marrow Transplant~   "
119560|NCT01490944|"~     The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation~     along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be~     randomly divided into two groups.~        -  Group 1: IFA weekly supplementation along with Information, Education, Communication~          sessions~        -  Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education,~          Communication sessions~      Duration of supplementation: 6 months~   "
119561|NCT01490931|"~     The surgical placement of dental implants is presently a common procedure performed by oral~     surgeons, periodontists, and general dentists. The surgery can be performed under local~     anesthesia and involves the incision of soft tissue to expose the underlying bone,~     preparation of the implant site using a specialized surgical drill, and.screwing the implant~     into bone using a specialized headpiece. Dental implant patients experience postoperative~     pain yet there are no studies in the literature which have evaluated the efficacy of~     analgesics in this patient population. The current pilot study will evaluate the analgesic~     effects and tolerability of a recently FDA-approved analgesic formulation of intranasal~     ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients~     will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total~     dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and~     pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2~     hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be~     recorded when and if they occur. Patients will then transition to a multi-dose phase where~     they will be allowed to dose with ketorolac as indicated in the package insert (up to 4~     times per day for 5 days). Patients will record the time of each dose, a daily assessment of~     overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650~     mg) on a take home diary.~   "
119562|NCT01490918|"~     Primary objective To evaluate the efficacy of Acarbose added on top of Metformin and~     Sitagliptin that were combinedly administered to subjects with type-II diabetes, along with~     placebos.~      Secondary objectives~        1. To compare a Metformin-Sitagliptin combination and a Sitagliptin-Acarbose combination~          in efficacy~        2. To evaluate the 6-month efficacy of Acarbose added on top of the Metformin-Sitagliptin~          combination~   "
119563|NCT01490905|"~     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug~     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and~     tolerability of Theramine alone in patients with chronic back pain in comparison to the~     NSAID, Ibuprofen, and the co-administration of Ibuprofen with Theramine.~   "
119564|NCT01490892|"~     This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for~     a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The~     primary objective of this trial is:~      To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging~     (HI) can improve the characterization of benign and malignant breast masses (independently~     or in combination with other imaging modes) compared to x-ray mammography, fundamental~     grayscale ultrasound (US) or power Doppler imaging (PDI).~      The secondary aim of this trial is:~      To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool &~     parametric imaging) measures of the vascular morphology of breast lesions determined by~     pathology and by SHI.~   "
119565|NCT01490879|"~     This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The~     study is being done to determine if Nexagon® plus standard of care is more effective than~     placebo plus standard of care. Standard of care will include debridement of the ulcer,~     standardized dressings and standardized off-loading using a Removable Cast Walker.~   "
119566|NCT01490866|"~     This is a non-randomized, open-label, Phase II trial investigating axitinib as a~     single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy~     for patients with mCRC.~   "
119567|NCT01490853|"~     Objectives~      This is an observational study aimed at updating the overall survival (OS), the progression~     free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response~     (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based~     therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing~     the clinical and biological features of this selected cohort of patients with persisting~     CCgR after treatment with IFN.~      Study design This study is an observational retrospective multicenter study.~      Assessment and Follow-up Patients' demographic data and retrospective collection of CML~     cytogenetic and molecular data will be reported in the Assessment and Follow-up FORM.~      In this FORM the events related to therapy, disease and survival will also be reported.~      Duration of the study:~      The recruitment period is estimated in approximately 2 years.~   "
119568|NCT01490840|"~     This study evaluated the effect of an individualized web-based physical training in~     fingolimod -treated patients.~   "
119569|NCT01490827|"~     This post-market surveillance study is conducted in the European Economic Area where Argus~     II has been CE certified for use in outer retinal degeneration patients. This study is being~     conducted to monitor the use of Argus II in a larger population than available within~     pre-market approval studies. Safety data will be monitored to ensure continued acceptability~     of risks to study participants, and an attempt will be made to include all eligible and~     willing participants implanted with Argus II. Measures of visual function that may~     contribute to device improvements will also be gathered and evaluated.~   "
119570|NCT01490814|"~     Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon~     catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with~     paroxysmal atrial fibrillation.~   "
119571|NCT01490801|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients~     with Epstein-Barr virus positive Hodgkin lymphoma.~   "
119572|NCT01490788|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102~     2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage~     precision and decreased potential for morning grogginess) and to compare the~     bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed~     conditions.~   "
119573|NCT01490775|"~     This study is being conducted in a population of patients with chronic phase Chronic Myeloid~     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral~     cancer drugs.~   "
119574|NCT01490762|"~     This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and~     effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.~   "
119575|NCT01490749|"~     The purpose of this study is to test the drug RAD001 in combination with another~     chemotherapy drug, Carboplatin, as well as radiation therapy in the treatment of esophageal~     cancer. Because RAD001 has not been used in this combination before, it is not clear which~     dose will be best when used in combination.~      The standard of care for patients who have esophageal cancer that has not moved to other~     areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy~     and possibly surgery. If the patient chooses to participate in this study, the patient will~     receive chemotherapy and radiation therapy. The patient will possibly also have surgery to~     have the cancer removed. This decision will be made by the treating physicians. All of the~     chemotherapy the patient will receive on the study is considered standard chemotherapy for~     esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will~     help improve the treatment for patients with this disease. RAD001 is a pill that has been~     used in many other types of cancer and has been proven to be effective in other cancers such~     as kidney cancer.~   "
119576|NCT01490736|"~     The purpose of this study is to determine the safety of photodynamic therapy (PDT) with~     lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.~   "
119577|NCT01490723|"~     The goal of this clinical research study is to learn if adding Zevalin (ibritumomab~     tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and~     fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma.~     The safety of this combination will also be studied.~      Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan~     is designed to attach to lymphoma cells and destroy the cells using a radioactive particle~     that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but~     the radioactive particle that is attached to it does not kill lymphoma cells. The~     radioactive particle makes the drug able to be seen inside your body. It is being used in~     this study to predict how fast the study drug will travel in the body and how long the drug~     stays in the body.~      Rituximab is designed to attach to lymphoma cells, which may cause them to die.~      Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.~      Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may~     increase the likelihood of the cells dying.~   "
119578|NCT01490710|"~     Despite spectacular advances since the 90s mechanical ventilation used in intensive care~     units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung~     parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a~     significant morbidity and mortality.~      NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous~     support, proportionate to patient's respiratory efforts. More physiological, this mode~     would decline its efficacy on patient hemodynamic response. However, to date, no study has~     focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study,~     which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.~   "
119662|NCT01489605|"~     Patients presenting for elective surgery requiring orotracheal intubation will be randomized~     to being intubated with either the GlideScope Groove video-laryngoscope or the standard~     GlideScope video-laryngoscope.~   "
119663|NCT01489592|"~     The purpose of this study is to determine the impact of curcumin, administrated orally, on~     iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin~     expression that the investigators observed in vitro and serum hepcidin levels.~   "
119579|NCT01490697|"~     Despite substantial therapeutic advances, Post-traumatic Stress Disorder (PTSD) remains~     difficult to treat. One promising new area of research is in post-reactivation pharmacologic~     intervention, which is based upon the concept of blockade of memory reconsolidation. Recent~     animal research suggests that reactivation (retrieval) of a stored memory can return it to a~     labile (alterable) state from which it must be restabilized in order to persist. This~     process is called reconsolidation, and various drugs have been found to block it in~     animals. This blockade may lead to a weakening of the original memory trace.~      The aim of this study is to pilot the effect of mifepristone on physiologic responding~     during traumatic imagery. Although mifepristone is widely and safely used to cause a medical~     abortion, it is also a powerful stress hormone receptor blocker. These stress hormones,~     called glucocorticoids, may enhance memory (re)consolidation. Indeed, a recent study in~     animals reported that mifepristone blocked reconsolidation of context-conditioned fear in~     rats.~      Reconsolidation blockade is a two-stage process. First, the memory must be destabilized by~     recalling it. Second, reconsolidation of the memory must be blocked by a drug. Memory traces~     formed under stressful conditions may resist destabilization and thus are inaccessible to~     reconsolidation blockers. However, when a reconsolidation blocker was paired with~     d-cycloserine (DCS) in animals that had been trained under stressful conditions,~     reconsolidation blockade became successful. These results suggest that DCS promotes the~     destabilization of resistant memory traces. The traumatic memories of individuals with PTSD~     may be particularly resistant to destabilization. Therefore, this study will compare~     mifepristone paired with DCS to placebo controls.~      The same script-driven traumatic imagery method validated in previous studies of propranolol~     in this lab will be used. Briefly, subjects with PTSD will describe their traumatic event~     during a script preparation session, which will reactivate the memory. They will then~     receive a) mifepristone and DCS or b) placebo. A week later, they will engage in~     script-driven mental imagery of their traumatic event while physiologic responses (heart~     rate, sweating, etc) are measured. This is a pilot study so there are no formal hypotheses.~     The aim is to estimate effect sizes for mifepristone and to compare them with effect sizes~     for propranolol from this lab's previous work.~   "
119580|NCT01490684|"~     Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in~     Saudi Arabia is not well studied. This observational study objectives include to determine~     the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill~     patients in Saudi Arabia.~   "
119581|NCT01490671|"~     Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug~     tenofovir may reduce the risk of HIV infection in women when used near the time of sexual~     intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected~     pregnant women and their newborns when the gel is used once a day for a period of 28 days at~     a designated time during pregnancy.~   "
119582|NCT01490658|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare repaglinide and metformin as co-administered tablets and as a combination tablet.~   "
119583|NCT01490645|"~     The purpose of the study is to analyse patient's acceptance and willingness to participate~     in a Structured Care Program (SCP) over 12 months following hospital discharge after Acute~     Coronary Syndrome (ACS) index event.~   "
119584|NCT01490632|"~     This is a dose-ranging study designed to investigate the efficacy and safety of LY3009104 in~     the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed~     by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.~   "
119585|NCT01490619|"~     Adolescents with type 1 diabetes are at increased risk for depressive symptoms, poor coping~     and problem-solving skills, poor regimen adherence, and negative diabetes-specific health~     outcomes. Although a handful of psychological interventions targeting adolescents' poor~     behavioral and emotional functioning demonstrate beneficial effects on disease management~     and outcomes, no prevention programs exist that equip adolescents with behavioral skills and~     cognitive strategies necessary to reduce these risks. Therefore, the proposed research will~     test whether a diabetes-specific adaptation of a resilience promoting, depression-prevention~     intervention for adolescents with type 1 diabetes will reduce both the risk of poor~     psychological functioning and the risk of negative health outcomes over time.~   "
119586|NCT01490606|"~     A. Background.~      Patients with osteoarthritis (OA) of the knee, suffer from a combination of pain, stiffness,~     joint instability, swelling and muscles weakness. This leads to decrease in quality of life,~     Active Daily living (ADL) and increase of medical services consumption in the community. OA~     of the knee, Is one of the world's common musculoskeletal disorder (18% among women and 10%~     among men). 80% of patients with OA of the knee suffer from decrease in mobility and 20% of~     them suffer an inability to perform everyday activities.~      Physical therapy training includes exercises for OA patients (Mild to Severe degree) is the~     cornerstone of non medicinal treatment. This training aimed to pain reduction, improved~     functioning and participation in family and working social life. Physical training with~     exercises can enhance physical capabilities such as: muscular strength, range of motion,~     balance, proprioception and cardiovascular performance. Other benefits are improving~     mobility, reducing risk of falls and body weight and improvement in psychological condition.~      B. Purpose~      The purpose of this research is to check the effectiveness of treatment in the framework of~     knee Osteoarthritis project compared to conventional Physical therapy in physical~     functioning, pain and quality of life scales, among patients over the age of 60 who suffer~     from OA of the knee .~      C. Research method~      A comparative non blinded, clinical trial will be conducted. This research will include 60~     independent patients divided into equal groups: Intervention group will be trained in knee~     Osteoarthritis project (in which patients receive 6 individual treatments and 6 Group~     treatments). Control group will be treated with conventional physical therapy, which~     includes 12 individual treatments. Effect of the treatment will be evaluated by: 1. WOMAC~     questionnaire- used to evaluate function and pain. 2. EQ-5D questionnaire for evaluating the~     quality of life. 3. Time up and go test- a Common functional test. This Questionnaires and~     test will be Performed before and after the study.~      D. Study hypothesis~      Physical therapy treatment within the framework of knee Osteoarthritis project is favor~     than the treatment of the conventional Physical therapy. Therefore the investigators expect~     much improvement in terms of pain, physical functioning and quality of life among~     intervention group compared to control groups.~   "
119587|NCT01490593|"~     The purpose of this study is to establish an eye injury registry to assess the mechanisms~     and outcomes of significant eye injuries occurring in Canada. The epidemiologic data will~     determine where public health strategies should be directed to prevent future eye injuries.~   "
119588|NCT01490580|"~     Multicenter double blind randomized controlled trial comparing atropine+propofol vs~     atropine+atracurium+sufentanil as a premedication prior to endotracheal intubation of the~     neonate.~      Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes:~     number of attempts, duration of the procedure, changes in physiologic parameters, short- and~     long-term neurodevelopmental outcome.~      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil will~     significantly reduce the frequency of severe hypoxemia.~   "
119589|NCT01490567|"~     The objective of the study was to study the effects of donepezil on cognition in patients~     with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled~     trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with~     schizophrenia.~   "
119590|NCT01490554|"~     The purpose of this study is to evaluate the presence of skin changes after grafting of~     autologous fibroblasts by means of biophysical, histological, immunohistological, gene~     expression, glycosaminoglycan, and sensitivity analyses.~   "
119591|NCT01490541|"~     The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a~     recommendation for Thai population.~      Objective:~      To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM)~     patient in order to propose the appropriate recommendation for Thai people.~      Research Design:~      Single center, retrospective-cohort study.~   "
119592|NCT01490528|"~     There is little data published on the long term durability of infliximab in pediatric~     patients. In particular a focus on durable remission, frequency of dose/frequency change and~     switch within class. Moreover 10 years of safety experience is rarely reported in children.~      The overall objective is to evaluate the persistence of infliximab as well as dosing~     strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab~     Regarding persistence of infliximab the investigators will be focusing on the proportion of~     patients who continue to have a durable response or remission to infliximab.~      The investigators will be assessing this by measuring the frequency of dose escalation,~     proportion of patients needing frequency change and proportion of patients switched to~     adalimumab or certolizumab.~      Safety outcomes will focus on frequency of malignancies, infections and immunogenecity~   "
119593|NCT01490515|"~     Metabolomics was recently introduced in human IVF for non-invasive identification of viable~     embryos with the highest developmental competence. The investigators intended to investigate~     if embryo assessment using non-invasive metabolomic profiling leads to increased~     implantation rates compared to routine morphology evaluation alone.~   "
119594|NCT01490502|"~     Low vitamin D levels have been shown to increase a person's risk of developing multiple~     sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk~     of having attacks. However, it is not known if giving supplemental vitamin D to those with~     MS reduces the risk of attacks, and some research suggests that vitamin D could even be~     harmful to people with MS.~      In this clinical trial, patients with relapsing-remitting MS will receive high-dose or~     low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate.~     Patients will be evaluated for two years, and the effect of high-dose vitamin D~     supplementation on the rate of MS attacks and on the number of new lesions and change in~     brain volume on MRI will be determined. Establishing this association will have major~     implications for the treatment of individuals with MS throughout the world.~   "
119595|NCT01490489|"~     The purpose of this study is to assess the potential prognostic value of seric~     concentrations of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will~     allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be~     proposed as prognostic marker for preeclampsia.~   "
119596|NCT01490476|"~     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth~     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients.~   "
119597|NCT01490463|"~     The purpose of this study is to determine the incidence and impact of brain lesions in MRI~     after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological~     outcome of patients.~   "
119598|NCT01490450|"~     The purpose of this study is to characterize the safety, efficacy and dose response of~     BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to~     Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying~     anti-rheumatic drugs (DMARDs).~   "
119599|NCT01490437|"~     Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single~     agent as first-line and second-line treatment for advanced urothelial carcinoma. The~     response rates were 32% and 28% for the first-line and second-line setting, respectively.~     Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently~     used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC~     (methotrexate, vinblastine, adriamycin, and cisplatin).~      Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung~     cancer with highly favorable toxicity profile.~      This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced~     urothelial carcinoma.~   "
119600|NCT01490424|"~     Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor~     expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a~     critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can~     protect against sepsis in mice. This study was designed to investigate whether TREM-1~     genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis~     patients with TREM-1 gene of four exons by PCR sequencing. When analyzing the results of~     sequencing, we found two gene polymorphisms located in exon-2 and exon-4, respectively.~     Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is~     non-synonymous variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous~     variation rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene~     were detected in 80 patients with severe sepsis and in 80 healthy control subjects. This~     study was explored that whether or not polymorphisms detected within the TREM-1 gene may~     play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.~   "
119601|NCT01490411|"~     The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic~     Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and~     also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is~     a vaccine that works by exposing your immune system to something that resembles birch. This~     vaccine may help to lessen your allergy symptoms during the natural birch season.~   "
119602|NCT01490398|"~     In ASCOT study, lipid lowering with a statin provided additional beneficial effects in~     hypertensive patients with average levels of serum total cholesterol. However, the~     underlying mechanism of statins to improve clinical outcomes in hypertension is unclear and~     the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive~     patients. Therefore, it is clinically important and timely project to measure CFR~     non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of~     statins in hypertensive patients with cardiovascular risk. The investigators try to evaluate~     the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of~     rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.~   "
119603|NCT01490385|"~     LED Phototherapy will increase the velocity of Orthodontic tooth movement.~   "
119664|NCT01489579|"~     The purpose of this study is to determine whether giving more structured information to~     patients over the phone about quitting tobacco helps to increase the chance that they will~     try to quit. The results of this study will help provide direction in developing a more~     standard way of helping patients to quit.~      Study Hypothesis:~      Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy~     specialists will significantly increase the percentage of self-reported tobacco cessation~     attempts compared to usual care among patients enrolled in a cardiovascular risk reduction~     program.~   "
119604|NCT01490372|"~     Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal~     hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is~     recognized as an entity with long-term serious sequels to the mother (GDM is considered a~     forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming~     hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and~     hypertension. However, these cross-sectional studies failed to control for maternal disease~     history and genetic background although heredity is a major epidemiology risk factor of type~     2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure,~     lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers~     and adipokines in-depth, despite the possible link between their presence and the~     development of metabolic and cardiovascular diseases in GDM offsprings.~      Exclusion of genetic confounding factors will help establish the role of GDM as an~     independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to~     identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity~     epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and~     offspring.~   "
119605|NCT01490359|"~     Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of~     all people living with HIV in 2003. South Africa continues to have the largest number of~     people living with HIV in the world, and as in other parts of sub-Saharan Africa,~     heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem~     the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited~     statistics indicate that about half of all people living with HIV are women. The strategies~     typically offered to address the impact of HIV on women are interventions with women.~      To be sure, there is an alternative approach to addressing women's risk of heterosexual~     transmission of HIV, one that would be an important complement to the predominant approach:~     namely, focusing on men. By reducing men's sexual risk behavior, it should be possible to~     reduce rates of HIV in both men and women. Men's rates would decline because they are the~     recipients of the intervention; women's rates would decline because they have sex with men.~     Interventions aimed at men could take into account the power that men have in sexual~     decision-making and risk taking. However, whether one considers the US literature or the~     international literature, few randomized controlled trials of HIV/STD risk-reduction~     interventions have focused on heterosexual men.~      Accordingly, the purpose of this research is to develop and test the efficacy of an~     intervention to curb HIV/STD risk-associated behavior in South African men who have sex with~     women. A cluster-randomized control trial design will be used to reduce the potential for~     contamination between treatment arms that would be present if individuals were randomized.~     An attention control group will be used to control for Hawthorne effects, special attention,~     and group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape~     Province, South Africa similar on key characteristics will be created, 22 pairs will be~     randomly selected, and men will be recruited. One neighborhood in each pair will be randomly~     assigned to each of the 2 study arms.~      The primary hypothesis is that men who receive a culturally appropriate theory-based HIV/STD~     risk-reduction intervention will be more likely to report consistently using condoms during~     vaginal intercourse in the 12-month post intervention period than will men who receive an~     attention-control intervention, controlling for baseline condom use.~   "
119606|NCT01490346|"~     The aim of this study is to find out why HIV continues to make copies in people taking HIV~     drugs. The investigators want to know if the medications most people use to treat HIV get~     into the lymphatic tissue where HIV persists.~   "
119607|NCT01490333|"~     Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and~     are leading causes of death among northern US NAs. Moreover, low vitamin D status occurs~     commonly in this same population. An increasing amount of evidence indicates a correlation~     between low vitamin D status and CVD and diabetes by contributing to a heightened~     pro-inflammatory environment within the endothelial lining of blood vessels leading to~     atherosclerotic disease, and an impaired sensitivity to insulin leading to diabetes. Our~     fundamental hypothesis is that low vitamin D status is a risk factor for CVD by causing a~     proinflammatory milieu, thereby leading to endothelial dysfunction. Additionally, the~     investigators hypothesize that vitamin D supplementation will reduce inflammation, thereby~     restoring endothelial function and ultimately reducing CVD risk.~   "
119608|NCT01490320|"~     The American Academy of Pediatrics recommends that parents receive anticipatory guidance~     about violence prevention as part of the routine well child visit. Educational resources are~     needed to help physicians routinely provide these important anticipatory guidance messages.~     In this study, consecutive parents will be exposed to routine anticipatory guidance messages~     before the well child visit with the physician. After the clinic visit, parents will be~     invited to participate in a research study to determine if they plan any changes at home.~     The key research question of this study is:~      Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids~     brochure, entitled, Pulling the Plug on TV Violence, help parents develop plans to~     decreases their children's exposure to violence in the media (e.g. less media time, no TV in~     the bedroom)?~   "
119609|NCT01490307|"~     The goal of this project is to empirically refine and improve a comprehensive~     family-centered prevention strategy for reducing and preventing adolescent substance use and~     other problem behaviors. This project builds on 15 years of programmatic research underlying~     the development of the Family Check-up model (FCU), originally referred to as the Adolescent~     Transitions Program (ATP; Dishion & Kavanagh, 2003), but later expanded as a general~     approach to mental health treatment for children from ages 2 through 17 (Dishion &~     Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within~     the context of a public school setting that comprehensively links universal, selected, and~     indicated family interventions. Previous research and the investigators' practical~     experience working in school settings indicate that the intervention strategy needs~     improvement in 3 critical areas to build on previous significant effects and to enhance the~     potential for future dissemination and large-scale implementation:(a) improve the~     feasibility of both the universal level and the indicated level of the intervention by~     broadening the intervention components and systematically embedding these components into~     the current behavioral support systems in the schools; (b) address the transition from~     middle school to high school, with special attention to academic engagement and reduction of~     deviant peer clustering; and (c) explicitly incorporate principals of successful~     interventions with families and young adolescents of diverse ethnic groups into both the~     universal and indicated models. An additional general goal of this study is to develop,~     test, and refine a set of research-based instruments that facilitate evaluation, training,~     implementation, and monitoring of intervention fidelity to maximize the potential success of~     implementation and large-scale dissemination.~      Participants include 593 youth and their families recruited from the 6th grade in three~     public middle schools in Portland, OR. Families were randomly assigned to receive either the~     FCU intervention model or treatment as usual. Assessments were collected for 5 years through~     the 10th grade. High school transition planning and intensive intervention efforts occurred~     in Grades 7-9.~      The investigators tested the hypothesis that the FCU intervention will reduce the growth of~     problem behavior and substance use through the enhancement of family management and parent~     involvement in school.~   "
119610|NCT01490294|"~     The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac~     Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT~     examination in terms of diagnostic quality.~      For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg~     body weight are administered. A study participant receives the respective dose twice i.e. at~     rest and at stress using Adenosine (which puts circulation into a state of stress similar to~     that of physical exercise). The time between both injections is 10-15 min.~      The total imaging time is about 45 min.~   "
119686|NCT01489293|"~     The purpose of this study is to analyze the expression and activity of inhibitory molecules~     on eosinophils obtained from allergic subjects.~   "
119611|NCT01490281|"~     Background The Al-Andalus physical activity intervention study is a randomised control trial~     to investigate the effectiveness of a land- and water-based exercise intervention for~     reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness~     and pain-related measures, body composition, functional capacity, physical activity and~     sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive~     function (secondary outcomes) in women with fibromyalgia.~      Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be~     recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain).~     Patients will be randomly assigned to a usual care (control) group (n=60), a water-based~     exercise intervention group (n=60) or a land-based exercise intervention group (n=60).~     Participants in the usual care group will receive general physical activity guidelines and~     participants allocated in the intervention groups will attend three non-consecutive training~     sessions (60 minutes each) per week during 24 weeks. Both exercise interventions will~     consist of aerobic, muscular strength and flexibility exercises.~      Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve~     patients' health status by implementing two types of exercise interventions. Results from~     this study will help to assess the efficacy of exercise interventions for the treatment of~     fibromyalgia. If the interventions would be effective, this study will provide low-cost and~     feasible alternatives for health professionals in the management of fibromyalgia. Results~     from the Al-Andalus physical activity intervention will help to better understand the~     potential of regular physical activity for improving the well-being of women with~     fibromyalgia.~   "
119612|NCT01490268|"~     The purpose of this study is to determine generation of a target controlled infusion model~     for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned~     open heart surgery, during which the strong analgesic, sufentanil, was used.~   "
119613|NCT01490255|"~     No previous study has assessed the potential of ranolazine to interfere with levels of~     platelet reactivity in patients with coronary artery disease who are treated with dual~     antiplatelet therapy.~      Aim of this study is to compare the pharmacodynamic effects of maintenance doses of~     ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease~     who are treated with dual antiplatelet therapy.~   "
119614|NCT01490229|"~     Pharmacologic alternatives in statin-intolerant patients include ezetimibe and~     nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The~     investigators will compare the efficacy and tolerability of ezetimibe versus a~     nutraceutical-based protocol in statin-intolerant patients treated with percutaneous~     coronary intervention.~   "
119615|NCT01490216|"~     The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability,~     plus reduction in cocaine use and craving.~   "
119616|NCT01490203|"~     The purpose of this study is to determine whether the global and segmental hepatic uptake~     and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard~     liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major~     hepatic resection or radiofrequency ablation (RFA).~   "
119617|NCT01490190|"~     This study will collect information on cycle control, acceptability and tolerability of the~     vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.~   "
119618|NCT01490177|"~     The Primary Objective of the study is to develop a customized regimen for oral immunotherapy~     that reflects what the subject is allergic in a clinically significant way (i.e., the~     offending food allergen is defined as a food allergen with a positive skin test or positive~     specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single~     and multiple food allergy subjects are included in the study.~   "
119619|NCT01490164|"~     Corrective surgery for scoliosis can result in prolonged operating room time and significant~     blood loss. The investigators goal is to determine what the transfusion requirements are for~     young adults undergoing spinal surgery for scoliosis and what other intra-operative factors~     influence the amount of blood and blood products used. The investigators will used the~     information obtained to improve the management of patients undergoing corrective surgery for~     scoliosis.~   "
119620|NCT01490151|"~     The purpose of this study is to evaluate a treat-to-range automated insulin management~     system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in~     individuals with type 1 diabetes.~   "
119621|NCT01490138|"~     Invasive fungal infection (IFI) is a disease usually occurred in the patients with~     compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation~     or long term immune suppression treatment with the incidence increasing over last decades.~     Given the introduction of numerous anti-fungal agents and great advance has been made in~     recent years, IFI is still a dangerous disease with high mortality.~      Early diagnosis of IFI is still a problem challenging the physicians. Serum tests of~     β-D-Glucan are introduced to the diagnosis of IFI, which have the advantage of easy~     application. However, the value of this test in the monitoring of antifungal treatment~     remains unclear.~      The investigators perform this study to evaluate the correlation of the serum test results~     of β-D-Glucan test with the treatment response during the anti-fungal treatment, and hope to~     see that the results of serial serum tests are good predictive markers for treatment~     response.~   "
119622|NCT01490125|"~     This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe~     Chronic Obstructive Pulmonary Disease (COPD) patients.~   "
119623|NCT01490112|"~     This study is conducted in Asia. The aim of this study is to observe the safety and efficacy~     of insulin aspart (NovoRapid®) administered via vial and three different devices.~   "
119624|NCT01490099|"~     This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence~     between insulin detemir produced by the NN729 process and by the current process in healthy~     subjects.~   "
119625|NCT01490086|"~     The objective of this study is to evaluate the efficacy and safety of RP5063 relative to~     placebo for the treatment of schizophrenia or schizoaffective disorder.~   "
119701|NCT01489098|"~     The purpose of this study is to determine if toddlers and children who were fed breast milk~     or infant formulas at different levels of protein between 3 and 12 months of age have~     differences in growth and body composition at 3 and 5 years of age.~   "
119626|NCT01490073|"~     Increasing ease of access of long-acting birth control methods, like intrauterine devices~     (IUDs), is an important way to reduce the risk of unintended pregnancy. Unfortunately, fear~     of IUD insertion in women who have not had children is common among health care providers~     and women alike, and this limits IUD use. To increase acceptance of this highly effective~     birth control method, there is a need to explore new, low cost, and easily applied methods~     to improve the insertion experience. This is a pilot study to evaluate the effectiveness and~     acceptability of nitroglycerin ointment applied vaginally to improve the IUD insertion~     experience for both patient and provider. The investigators hypothesis is that nitroglycerin~     ointment will decrease the pain associated with IUD insertion.~   "
119627|NCT01490060|"~     The goal of this clinical research study is to learn how different doses of fosaprepitant~     may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want~     to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that~     may be caused by chemotherapy. The safety of this drug will also be studied.~      Fosaprepitant is designed to block the natural substance in the brain that causes nausea and~     vomiting. This may help to prevent and/or control nausea and vomiting caused by~     chemotherapy.~   "
119628|NCT01490047|"~     Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant~     human tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in~     combination with liposomal doxorubicin in human subjects~   "
119629|NCT01490034|"~     Due to the rising incidence of obesity, much emphasis has been placed on identifying~     mechanisms of increased energy intake. At this point, the mechanisms responsible for the~     recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive~     influences, such as cognitive factors, may play a larger role in creating an energy surplus~     than previously thought. Expectations about the satiating effect of a food may override the~     post-ingestive influences in dictating further consumption. In addition, obese individuals~     may exhibit a decreased compensatory response to foods as compared to lean individuals.~      Understanding the effects of energy content, food form, and learning on satiation, satiety,~     and energy intake will allow for a greater understanding of the mechanisms of energy~     imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive~     effects. By utilizing foods with similar sensory properties, the acquired knowledge derived~     from ingesting these foods can be monitored by analyzing subsequent intake at the same meal~     and at subsequent eating occurrences. It is hypothesized that the liquid food form will~     elicit weaker dietary compensation; that is, energy intake at other eating events will not~     be adjusted to compensate for that food. In addition, it is posited that the lower energy~     food will cause lower compensation postprandially. By having participants consume the same~     test food daily over a two week learning period, it is thought that they will show improved~     dietary compensation when the initial testing is repeated due to learned associations~     between food properties and metabolism.~   "
119630|NCT01490021|"~     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's~     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic~     Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing~     virtual and transient lesions, mimicking those observed in MCI. It has proven repeatedly~     its capacity to interfere with encoding-retrieval memory task. However, to date, only few~     imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the~     stability of TMS effects over time remains to be investigated. If proven to be a stable~     interfering challenge, TMS could be used to investigate the potential restoring effect of~     new medication in AD.~      The study is the pilot study of a larger clinical trial which aims to prove the utility of~     rTMS as a potential model for prediction of clinical efficacy using a combination of~     cognitive and neuroimaging endpoints.~   "
119631|NCT01490008|"~     Investigation of systemic catechin exposure following topically administered Veregen® 15%~     ointment in patients with external genital and perianal warts and following oral intake of a~     standardized green tea beverage in healthy subjects.~      Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin~     exposure following dermal administration in the patient group will only be calculated if~     sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations~     to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations.~      If applicable, a safety margin for ointment use might need to be established with respect to~     intolerable systemic exposures of catechins following application of Veregen® ointment.~      In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg~     three times daily: in the morning, at midday, and in the evening on the defined anogenital~     administration area (total dose of 750 mg/d) for one week .~      In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea~     beverage (Lipton® Green Limone distributed by PepsiCo Deutschland GmbH, Neu-Isenburg,~     Germany), three times daily in the morning, at midday, and in the evening (total dose of~     1500 mL/d) for one week.~      Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24~     hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first~     dosing).~      To avoid any influence on overall systemic catechin exposure deriving from any other source~     than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and~     healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages~     known to containing catechins (a list of all prohibited and allowed foods and beverages will~     be provided to all subjects).~      For concomitant medication, only paracetamol and oral contraceptives are allowed.~   "
119632|NCT01489995|"~     A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl~     pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to~     1 of 5 treatment sequences and will receive each treatment over the course of 5 weekly~     periods.~   "
119633|NCT01489982|"~     More than half of patients with Parkinson's have troubles with insomnia. There are several~     treatment options for insomnia that have been studied in the general population - however,~     the investigators don't know if these treatments work for patients with Parkinson's. It is~     possible that people with Parkinson's may have different treatment responses.~      The goal of this project is to test in a pilot study the tolerability and effectiveness of~     pharmacologic and non-pharmacologic treatments to improve insomnia in patients with~     Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and~     fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light~     therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications.~     The treatment that each person will receive first will be chosen randomly. If the first~     therapy has not been effective, participant may choose to re-enrol in the trial with one of~     the remaining two therapies.~   "
119874|NCT01486849|"~     A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple~     ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a~     within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole~     once daily (QD).~   "
119634|NCT01489969|"~     This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo~     controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to~     receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is~     to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia~     patients aged 18-80 years, following the first two nights (immediate effect) and at the end~     of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency~     to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of~     treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The~     secondary endpoints are number of awakenings after sleep onset and the duration of wake~     after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the~     study; mean of two consecutive nights recordings).~   "
119635|NCT01489956|"~     The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH)~     and to determine if Immucothel by itself is strong enough to trigger the immune response. If~     not, Immucothel will be tested in combination with an adjuvant to determine if an adequate~     immune response can be seen.~   "
119636|NCT01489943|"~     The purpose of this study is to test the effects of study drug (GSK1605786) on the blood~     levels of multiple commonly used drugs that are given to measure how your liver breaks down~     the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and~     rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down~     (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of~     GSK1605786, and two metabolites, [GSK2635622 (CCX062) and GSK2656694 (CCX304)] and four~     probe substrates will be collected over a 24-hour period after administration. Safety will~     be assessed by the measurement of vital signs, cardiac monitoring, collection of adverse~     event assessments and laboratory tests.~   "
119637|NCT01489930|"~     Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This~     are-related decline in skeletal muscle mass and skeletal muscle strength is a major~     underlying factor contributing to many of the metabolic disorders and frailty of the~     investigators rapidly expanding aging population. Endurance (aerobic) and resistance~     exercise training programs have been shown to effectively reverse the age-related decline in~     metabolic and contractile muscle functions. The investigators will measure synthesis rates~     of individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people~     to determine their response to 8 weeks each of endurance, resistance, combined endurance and~     resistance training, or placebo exercise training.~      Hypotheses.~        1. to measure fractional synthesis rates of multiple muscle proteins and identify those~          that are enhanced by an endurance exercise program~        2. to determine whether changes in protein synthesis in response to endurance exercise~          programs are dependent on age~        3. to measure fractional muscle synthesis rates of multiple muscle proteins and to~          identify those that are enhanced by a resistance exercise program~        4. to determine whether changes in protein synthesis in response to resistance exercise~          programs are dependent on age~   "
119638|NCT01489917|"~     The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary~     angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori~     heparin use in patients undergoing transradial coronary angiography to a strategy of~     provisional heparin administration only if patent hemostasis is not achievable.~   "
119639|NCT01489904|"~     The purpose of this study is to evaluate the safety and efficacy of botulinum toxin-A in~     salivary glands as a treatment for decrease drooling in patients with cerebral palsy and~     evaluate the long-term effects and tolerance . To assess whether patients with cerebral~     palsy have hypersalivation comparing with patients without treatment and healthy volunteers~     and if botulinum toxin may reduce the volume of drooling without altering the swallowing~     function.~   "
119640|NCT01489891|"~     The purpose of this study is to determine the efficacy of application of the anaesthesia~     topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation,~     in therms of dosage and side effect´s reduction overall.~   "
119641|NCT01489878|"~     In this prospective, observational, multicentric open study, the investigators will compare~     the acquisition rates of methicillin-resistant staphylococci (coagulase-negative~     staphylococci and Staphylococcus aureus) nasal carriage in community patients receiving an~     ambulatory antibiotic treatment by either a β-lactam (amoxicillin-clavulanate or penicillins~     M), a macrolide, a synergistin or a fluoroquinolone.~   "
119642|NCT01489865|"~     People are being asked to participate in this study who have metastatic pancreatic cancer~     (cancer that has spread to other parts of the body).~      The purpose of this study is to test the efficacy (effectiveness) of a new combination of~     drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with~     metastatic pancreatic cancer.~      ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this~     enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and~     will hopefully increase the killing of cancer cells, thus decreasing the tumors in your~     body.~   "
119643|NCT01489852|"~     The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of~     2 additional oocytes in GnRH antagonist protocol.~   "
119644|NCT01489839|"~     The primary purpose of the study will be to look for biological biomarkers to determine~     which people with gum disease will have a worsening of the disease. A second objective of~     this study will be to look at the effects of periodontal treatment on the levels of the~     biomarkers that are identified.~   "
119645|NCT01489826|"~     This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes~     of this protocol are to study different doses of the study drug to determine the maximum~     safe dose and to further understand the safety of the study drug; to understand what the~     body does to the study drug; to understand what the study drug does to the body and to~     measure any reduction in size of patients' cancer tumour(s).~      Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which~     was initially investigated as a neuroprotective agent. Because of its method of action~     however it is thought that it may have the effect of destroying cancer cells by reducing the~     level of control on networks that prevent cancer cells dying.~   "
119875|NCT01486836|"~     The objective of this study is to investigate the safety and efficacy of the Lumax DX /~     Linox DX system.~      No hypothesis has been defined.~   "
119646|NCT01489813|"~     Patients with non-invasive bladder cancer are often treated with intravesical therapy in~     order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower~     urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of~     treatment. There have been a number of studies that suggest a chemical found in soy beans~     may be able to help with these side effects. This chemical is called genistein and can be~     extracted and given to study subjects in pill form. In this study, the investigators would~     like to have patients placed into two different groups. One group would take genistein and~     the other group would take a placebo, a sugar pill that looks like the genistein pill. In~     doing this study the investigators hope to explore the findings from other studies to see if~     lower urinary tract symptoms are reduced and to see if recurrence rates for patients are~     affected by genistein. The study would take about four and a half months total.~   "
119647|NCT01489800|"~     Complications after radical cystectomy for bladder cancer range from 30-40%, many of which~     are related to bowel function. Patients usually wait to eat until return of bowel function,~     although there is evidence that after primary intestinal or colonic surgery, patients may~     take food ad lib immediately, and that this is is associated with lower complication rate~     and shorter length of stay. The investigators hypothesize that early access to oral enteral~     nutrition (food at will) after cystectomy and urinary diversion will reduce the complication~     rate both in-hospital and within 90 days after hospital discharge.~   "
119648|NCT01489787|"~     The purpose of this study is to assess the feasibility, safety and efficacy of High~     Intensity Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver~     metastases. This is a phase I/II study.~   "
119649|NCT01489774|"~     Study objectives~        -  To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral~          doses of CJ-12406 in healthy male subjects.~        -  To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to~          healthy male subjects.~        -  To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406~          in healthy male subjects.~   "
119650|NCT01489761|"~     This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting~     stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime~     or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.~   "
119651|NCT01489748|"~     This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work~     capacity of participants with multiple sclerosis (MS) starting on this device. This study~     will also evaluate as secondary endpoints various patient-reported outcomes over the~     short-term (1 month), including adherence, treatment satisfaction and convenience, and the~     long-term (12 and 24 months), including adherence, persistence, quality of life (QOL),~     treatment satisfaction and convenience. It will also assess health resource utilization by~     MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability,~     and will correlate all secondary outcomes with the primary (i.e., work capacity).~   "
119652|NCT01489735|"~     There are three main directions for use GerdQ in practice. First of all, GerdQ can be used~     to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the~     specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the~     patient's life and help in choosing treatment of GERD, as well as direct assessment of~     treatment efficacy.~      In connection with mentioned above, this study is devoted to the estimation of possibility~     to use GerdQ in routine practice of Russian physicians.~   "
119653|NCT01489722|"~     The purpose of this open label study is to evaluate the safety, tolerability,~     pharmacokinetics, and efficacy of AZD1208 in patients with recurrent or refractory Acute~     Myelogenous Leukemia (AML). This study will have two parts. In Part A, patients will receive~     escalating doses to identify the maximum tolerated dose (MTD). In Part B, the efficacy of~     the maximum tolerated dose will be evaluated in a expanded group of patients.~   "
119654|NCT01489709|"~     This study is to evaluate the effect of Vesicare on quality of life (QOL) in female~     patients.~   "
119655|NCT01489696|"~     The study aims to compare blood pressure and pulse in male healthy subjects taking~     mirabegron and tamsulosin both alone and in combination.~   "
119656|NCT01489683|"~     When not using neuromuscular blocking agent, even at optimal dosage, target-controlled~     infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating~     conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on~     the intubating conditions for tracheal intubation during anesthesia induction of propofol~     and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.~   "
119657|NCT01489670|"~     This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan~     ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who~     are treated per routine clinical practice.~   "
119658|NCT01489657|"~     The purpose of this prospective observational study is to generate further insight into the~     numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects~     by profiled serum metabolites before and after the surgery and integrated metabolite changes~     with clinical data.~   "
119659|NCT01489644|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare repaglinide and metformin administered as an individual tablets with repaglinide and~     metformin administered as a combination tablet.~   "
119660|NCT01489631|"~     Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation~     and hospital discharge might be delayed. Recent research shows that intra-articular~     infiltration with local anesthetics and perioperative prescription of gabapentin can improve~     outcome.~      Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of~     patients after total knee replacement surgery which is treated with epidural analgesia or~     peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of~     postoperative opiate consumption.~   "
119661|NCT01489618|"~     The main objective of this study is to evaluate and to compare the specific antibody~     response to a  prime-boost  vaccine strategy combining the seven valence pneumococcal~     conjugate vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal~     capsular polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal~     capsular polysaccharide vaccine (PPS) alone at W4 in patients with common variable~     immunodeficiency.~   "
119665|NCT01489566|"~     This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial.~     Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be~     randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection),~     or placebo.~      The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free~     survival,overall survival,quality of life,and the safety and tolerability of subjects after~     the resection of hepatocellular carcinoma~   "
119666|NCT01489553|"~     For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management~     includes identification of the causative food and avoidance. Egg allergy is among the most~     common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of~     children (its prevalence is higher in children with atopic dermatitis or other food~     allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim~     to investigate the safety and efficacy of baked egg oral immunotherapy.~   "
119667|NCT01489540|"~     Accurate early burn depth assessment is important to determine the optimal treatment. The~     most applied method to asses burn depth is clinical assessment. This method is the least~     expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately~     assess burn depth. The clinical effects, the costs and cost-effectiveness of this device~     however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an~     earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably~     leads to a decrease in wound healing time, in length of hospital stay and in costs.~      Before the investigators decide to implement LDI in Dutch burn care a study of the clinical~     effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized~     controlled trial will be conducted, including all patients with burns of indeterminate depth~     (burns that are not obviously superficial or full thickness) treated in the Dutch burn~     centres. In total 200 patients will be included in an 18 months period. The patients are~     randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic~     strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler~     imaging in all patients. The results of the LDI-scan will be provided to the treating~     clinician in the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and~     therapeutic decisions, and costs are observed.~   "
119668|NCT01489527|"~     Moffitt Cancer Center is the Coordinating Center for this study.~      The purpose of this study is to develop and test the infrastructure to conduct a future~     Phase III vaccine efficacy trial to assess trial feasibility, and to assess human~     papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The~     investigators propose to conduct a Preparedness study among women ages 16-24 years of age~     residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and~     prevalence.~      The specific aims of this study are to:~        1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm,~          400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18~          [Gardasil]) or placebo vaccine.~        2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical~          lesion prevalence among young females ages 16-24 years at high risk for HIV infection.~        3. Assess the rate of compliance through the 3-dose vaccination series~   "
119669|NCT01489514|"~     This is a proof of concept study to determine the safety and allergenicity of hypoallergenic~     peanut product extract as compared to standard peanut extract in an adult population with~     known peanut allergy. This will be assessed by epicutaneous skin prick testing. The~     hypothesis is that subjects with previously diagnosed peanut allergy will have less~     epicutaneous reactions to the hypoallergenic peanut product extract.~   "
119670|NCT01489501|"~     This clinical study is a scientific study on patients who do not have any limbal stem cells.~     In this clinical study tissue is taken from the inside of the mouth, and cells from that~     tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS,~     which is then transplanted onto the cornea. This transplantation method should repair the~     damage of the cornea.~      The aim of this study is to see if the transplantation of CAOMECS renews the surface of the~     eye, by preventing the growth of the conjunctiva over the cornea and stopping new small~     blood vessels forming.~   "
119671|NCT01489488|"~     Primary objective: To determine oral bioavailability of the liquid formulation intended for~     pediatric use and potential food effects in healthy adults.~      Secondary objective: To evaluate safety and tolerability measured by physical examination~     findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events~     (AEs).~   "
119672|NCT01489475|"~     During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many~     foreign entities. These conditions trigger the body's inflammatory response which results in~     leaky capillaries, increased swelling and possibly organ dysfunction. Since the early~     1990's, modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce~     bleeding, improve heart function, and decrease hospital length of stay. Angiopoietins are a~     family of proteins necessary for both normal and abnormal blood vessel formation. They also~     appear to play a role in capillary leak. Though MUF has been shown to improve clinical~     outcome following CPB, there continues to be conflicting reports whether this is a result of~     the filtration of inflammatory proteins or simply from excess fluid removal. Since~     angiopoietins appear to play a role in both inflammation and capillary leak, the~     investigators hypothesize that the benefit seen after MUF is also secondary to its ability~     to filter out these proteins, especially angiopoietin-2.~   "
119673|NCT01489462|"~     The primary purpose of this study is to compare the effects of a high and low intensity~     strength training programs vs. a control group on knee pain and compressive joint forces.~   "
119674|NCT01489449|"~     The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R)~     Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.~   "
119675|NCT01489436|"~     New minimally invasive surgical treatments are often outpatient procedures with low~     complication rates, promising fast recovery. The traditional physician-reported outcomes~     such as complication rates, blood loss, and hospital stay are not useful to guide treatment~     recommendations for one or the other minimally invasive procedure. This study aims to apply~     patient-reported outcomes developed within the NIH framework for cancer research and chronic~     disease treatment to the comparative effectiveness research in minimally invasive procedures~     for benign disease.~   "
119676|NCT01489423|"~     RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with~     ipilimumab with or without sargramostim may help doctors learn more about the effects of~     ipilimumab and sargramostim on cells. It may also help doctors understand how well patients~     respond to treatment.~      PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III~     melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.~   "
119677|NCT01489410|"~     Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used~     method for the palliative or curative treatment of these lesions. These attempts are being~     made to make these patients a better candidate for liver transplant or to provide palliation~     for their condition.~   "
119678|NCT01489397|"~     Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy~     (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial~      Research Question:~      Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?~      Objective:~      To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal~     metaplasia.~      Hypothesis:~      Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal~     metaplasia.~      Research design:~      Diagnostic study~      Sample size:~      The investigators follow the population in recent study from Imraporn et al.: Validity of~     magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)~      Data analysis:~      Confocal Barrett's esophagus classification was used to evaluate agreement of confocal~     endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for~     GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold~     standard for diagnosis, and reported as sensitivity, specificity, positive predictive value,~     negative predictive value and accuracy of these criteria.~      Expected Benefit and Application:~      The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in~     order to improve the quality of GIM/dysplasia/early gastric cancer detection and then~     decrease the mortality rate from gastric cancer in the future.~   "
119679|NCT01489384|"~     The purpose of this study is to investigate the safety and efficacy of Cimzia given as an~     add-on to your current therapy with disease-modifying anti-rheumatic drug(s)~     (DMARDs)including MTX or given as monotherapy (alone) over an 18 month period.~      Approximately 125 patients with moderate to severe Rheumatoid Arthritis (RA) who are being~     prescribed Cimzia will be enrolled into the study.~   "
119680|NCT01489371|"~     This phase I trial studies the side effects and the best dose of giving EGEN-001 together~     with pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or~     persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.~     Biological therapies, such as EGEN-001, may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal~     doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Giving EGEN-001 together with~     pegylated liposomal doxorubicin hydrochloride may kill more tumor cells.~   "
119681|NCT01489358|"~     Background:~      - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache,~     muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the~     joint pain, which may be directly related to the infecting virus, may be severe and last for~     several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new~     experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy~     adults. Participants cannot develop CHIKV from this vaccine.~      Objectives:~      - To test the safety and effectiveness of a Chikungunya virus vaccine.~      Eligibility:~      - Healthy individuals between 18 and 50 years of age.~      Design:~        -  This study, including vaccine doses and followup tests, will last about 44 weeks.~          Participants will have three vaccination visits, six followup clinic visits, and three~          telephone contacts during this study. Vaccination visits will take about 4 hours. Most~          other clinic visits will usually take 2 hours. The telephone contacts will take about~          15 minutes.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will also be collected.~        -  Participants will be assigned to one of three dose groups. Information about doses will~          be provided before the start of the vaccinations.~        -  Vaccine injections will be given at the start of the study, at 4 weeks, and at 20~          weeks. Participants will be asked to keep an eye on the injection site for 7 days and~          to notify researchers if there are any side effects.~        -  Participants will be monitored throughout the study with blood samples and clinic~          visits.~   "
119682|NCT01489345|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952~     across ascending multiple doses in healthy adult male and female subjects. The secondary~     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.~   "
119683|NCT01489332|"~     The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is~     standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate~     to less than 10%, but has only had limited effect on overall survival due to the constantly~     high (more than 30%) rate of distant metastasis.~      Complete eradication of the primary tumour observed in the histopathological specimen~     (pathological complete response, pCR) correlates with a favourable overall prognosis so~     obtaining a pCR might be beneficial. The aim of the study is to investigate whether the~     addition of capecitabine based chemotherapy before preoperative chemoradiation and also~     before the operation improves pathological complete remission rate in locally advanced~     rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological~     downstaging rate, histopathological R0 resection rate,sphincter preservation rate,~     perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality~     of life.~   "
119684|NCT01489319|"~     The purpose of this study is to determine the relationship between lipid-induced~     inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS);~     and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing~     resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and~     ovulation in a subset of normal weight women with PCOS.~   "
119685|NCT01489306|"~     The purpose of the study is to assess the tolerability and safety of a range of repeated~     inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and~     determination of blood levels of MDT-637 following inhalation.~   "
119687|NCT01489280|"~     In this study, the body temperatures of men and women undergoing elective surgery will be~     measured using the Temple Touch Pro. In the operating room, each patient's temperature will~     be measured with both the Temple Touch Pro and another one or two of the continuous~     reference methods used clinically for measuring the core temperature.~      The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a~     receiving unit. The former is attached to the skin, while the latter is placed near the~     patient or the vital signs monitor and receives data from the patch. The core temperature~     equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by~     conductive sensors that perform skin temperature measurements and then applies a special~     algorithm in order to calculate the body's temperature.~   "
119688|NCT01489267|"~     Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly~     involving the cerebellum, but the spinal cord and cranial nerves may also be some~     involvement. A total of 20 molecularly diagnosed SCA1 patients divided in two groups. One~     group accepted for the treatment of stem cell transplantation,the other group will be the~     control. Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem~     cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia~     is valid.~   "
119689|NCT01489254|"~     The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer~     acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting~     multiple sclerosis~   "
119690|NCT01489241|"~     The purpose of this study is to evaluate whether the introduction of a short-term~     telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged~     from the hospital after disease exacerbation produces benefits in terms of a reduction in~     hospital readmissions and health related quality of life. In addition the trials evaluate~     the economical and organisational impact of the services and examine their acceptability by~     patients and health professionals.~   "
119691|NCT01489228|"~     This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in~     individuals with chronic indeterminate Chagas disease recruited in research centres in~     Tarija and Cochabamba, Bolivia.~   "
119692|NCT01489215|"~     This study will inform the field about underlying mechanisms associated with infant sleep~     problems and will deepen the understanding of the intervention process. The study will~     provide detailed information on the intervention process itself and will explore how~     behavioral sleep interventions affect broader infant outcome.~   "
119693|NCT01489202|"~     Percutaneous coronary intervention (PCI) with stenting may induce endothelial~     damage/dysfunction and inflammatory reactions, which in turn delay healing and~     endothelialization and may lead to restenosis and atherosclerosis within the stented~     segments. Drugs and polymers are considered the protagonists of these pathophysiologic~     processes whereas the role of stent platforms remains poorly defined.It remains unknown,~     conversely, if stent platforms affect the extent of post-PCI endothelial damage and~     inflammation.~   "
119694|NCT01489189|"~     The primary objective of the protocol is to determine if visual acuity outcomes at 2 years~     in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial~     growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are~     non-inferior to those in eyes that receive standard prompt PRP therapy.~      Secondary objectives include:~        -  Comparing other visual function outcomes (including Humphrey visual field testing and~          study participant self-reports of visual function) in eyes receiving anti-VEGF with~          deferred PRP with those in eyes receiving prompt PRP.~        -  Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of~          prompt PRP.~        -  Comparing safety outcomes between treatment groups.~        -  Comparing associated treatment and follow-up exam costs between treatment groups.~   "
119695|NCT01489176|"~     The purpose if this study is to examine how effective Regadenoson is in detecting coronary~     artery disease during a stress echocardiogram when Optison is administered. Optison is a~     contrast agent that improves the images of the heart on the echocardiogram (echo) machine.~     Optison is approved by the Food and Drug Administration (FDA) to use during stress~     echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is~     used to chemically increase the heart rate and is approved for nuclear imaging tests.~     Regadenoson is a FDA approved drug but not for the intended use in this study.~   "
119696|NCT01489163|"~     The purpose of this research study is to implement and evaluate a lifestyle program designed~     to help women who have high glucose levels during pregnancy make healthful diet and physical~     activity changes to lose weight. Eligible women will be randomly assigned to life-style~     intervention or usual medical care.~   "
119697|NCT01489150|"~     In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory~     failure, the interest of using the End-tidal Co2 measurement device Capnostream to~     evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done~     under normal expiration and under prolonged active and passive expiration maneuvers.~   "
119698|NCT01489137|"~     The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic~     changes to head fixation in the patients undergoing neurosurgery.~   "
119699|NCT01489124|"~     This is prospective, randomized and crossover design to assess the pharmacokinetic and~     pharmacodynamics of three regimen.~        -  0.5-hr infusion of imipenem 0.5 g every 6 hrs~        -  2-hr infusion of imipenem 0.5 g every 6 hrs~        -  2-hr infusion of imipenem 1 g every 6 hrs~      Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs,~     APACHE II score, BUN, Cr, Sample and Blood culture will be collected.~      Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3~     days in this study, all patients will receive other sensitive antibiotics to eradicate their~     bacterial infections.~      Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following~     time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.~      Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be~     simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and~     reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).~   "
119700|NCT01489111|"~     This trial is conducted globally. The aim of this trial is to evaluate the haemostatic~     effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.~   "
119702|NCT01489085|"~     Rational: Intellivent is a ventilation mode completely automated which controls ventilation~     and oxygenation parameters. Safety and performance of IntelliVent has still been~     demonstrated in post operative heart surgery for patient with a controlled ventilation on~     short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for~     Intensive care unit patients from intubation to coming off.~      Primary objective : Compare parameters which have been selected by automated mod~     (Intellivent) to those selected by clinical practitioner in a conventional mode~      Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters.~     Record complications, number of manual adjustments and prognostic signs.~      Methodology: Patients in the intensive care unit who need invasive ventilation. They will be~     included after a detailed information (information note). Oxygenation and ventilation~     parameters will be recorded 2 times by day from intubation to coming off. The investigator~     in charge will determine daily at the bedside of the patient the adjustments he should make~     in a conventional mode. These adjustments will be compared to the IntelliVent automated~     adjustments.~      Experimental study, observational, prospective, comparative, opened, monocentric in an~     intensive care unit.~      Number of patients: 100~   "
119703|NCT01489072|"~     This study is designed to compare the effects of two bolus doses of intravenous remifentanil~     given prior to the emergence of anesthesia:~        -  on the incidence of perioperative coughing~        -  on the time needed for the emergence of a desflurane-based anesthesia~        -  on the incidence of sore throat after extubation.~      The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5~     mcg/kg) given prior to emergence of a desflurane-based anesthesia will reduce the incidence~     of perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).~   "
119704|NCT01489059|"~     The purpose of this study is to determine whether the combination of interleukin-21 (IL-21)~     and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the~     clinical benefits of the combination compared with Ipilimumab alone~   "
119705|NCT01489046|"~     The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well~     tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for~     treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects~   "
119706|NCT01489033|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic disease the aim of this study was~     to assess safety and tolerability of three different subcutaneous immunotherapy dose~     escalations in patients allergic to the pollen of Phleum pratense.~   "
119707|NCT01489020|"~     Based on EMA (European Medicines Agency) new guidelines on the clinical development of~     products for immunotherapy for the treatment of allergic diseases the aim of this study was~     to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations~     in patients allergic to Dermatophagoides pteronyssinus.~   "
119708|NCT01489007|"~     Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet~     for children. Advocates make strong health claims whereas others have expressed safety~     concerns, especially regarding iron nutrition. The frequency of vegetarianism among children~     is said to be rapidly increasing although clear data are not available. Surveys of children~     in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo~     vegetarian, with some fish or chicken products in the diet. This is a substantial proportion~     that is very likely to increase over the next few years with essentially no nutrient~     metabolism data related to this population.~      One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many~     children, is the lack of heme iron in the diet. A key question that can be evaluated in~     children is whether iron status is in fact affected by a lacto-ovo vegetarian diet.~      According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th~     Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending~     on the level of dietary restriction, fortified foods or supplements may be necessary during~     different life stages. In addition, strict vegetarian children may have slightly higher~     protein needs compared to non-vegetarian children due to decreased protein digestibility in~     certain plants. The AAP further recommends that children 4-8 years old consume a minimum of~     five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich~     foods.~      To evaluate this issue, the investigators will use a stable isotope method to directly~     assess iron status. It is increasingly recognized that the ability to absorb iron when given~     with vitamin C is a highly accurate measurement of iron status and may be a true gold~     standard in this regard. In this planned study, investigators will be able to assess both~     reference dose iron absorption and standard biochemical markers of iron status in a group of~     lacto-ovo vegetarians and compare them with age- and gender-matched children on a~     non-vegetarian diet. These data can be important in determining if iron status is decreased~     in lacto-ovo vegetarians and will serve as a basis for future interventions and evaluations~     if a difference is found.~   "
119709|NCT01488994|"~     The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its~     hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life~     in pediatric patients.~   "
119710|NCT01488981|"~     This study will evaluate the feasibility of using fully implanted microstimulators to~     rehabilitate arm function in patients who have suffered a traumatic brain injury.~   "
119711|NCT01488968|"~     Hypofractionated regimen in high-risk prostate cancer will allow the investigators to~     deliver higher biological doses to targets in order to improve tumor control and with~     acceptable rectal toxicity compared to conventional fractionation.~   "
119712|NCT01488955|"~     In this study, patients with uncomplicated urinary infection are investigated. It is~     investigated if treatment of only symptoms of the uncomplicated urinary infection is as~     effective as treatment with antibiotics with respect to the outcome of the urinary~     infection. If this is the case, the use of antibiotics in the treatment of uncomplicated~     urinary infections might be reduced.~      Secondary aim of the study is the safety evaluation of both treatment strategies with~     respect to SAEs during treatment. Additionally, relapse frequency after 28 days is~     evaluated.~   "
119724|NCT01488799|"~     The current study examines whether change-readiness, and consequently treatment outcome, can~     be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder~     (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra~     & Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD~     will be randomly assigned to receive an equal number of sessions of either MI and CBT~     (MI-CBT arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to~     the CBT alone arm will show lower levels of resistance in CBT, higher levels of homework~     compliance and therapeutic alliance, better moment-to-moment interpersonal process, and~     consequently superior outcomes - both post-treatment and at 6 and 12 month follow-ups.~   "
119725|NCT01488786|"~     The purpose of this study is to assess the safety of the BrainPort vision device and to~     demonstrate improved object recognition and word identification and ambulation with use of~     the BrainPort vision device in subjects who are medically documented as blind, with acuity~     of 20/ 5000 or worse.~   "
119713|NCT01488942|"~     In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV~     infection among users of illicit drugs. Among drug users who present to care and start~     highly active antiretroviral therapy (HAART), retention in care and adherence to their~     treatment regimen may be less than optimal. Given the known benefits of HAART on both the~     individual and populational levels, new strategies are required to help retain HIV-infected~     drug users on HAART.~      Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g.~     money) to reinforce the desired behaviour. CM has been used with success in other areas of~     medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not~     been established as a means to improve retention in HAART programs.~      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in~     retaining HIV-infected drug users in HAART programs. 240 HAART-eligible subjects will be~     randomized in a 2:1 ratio to either receive (n=160) the reinforcer or to a control arm~     (n=80). All subjects will receive HAART and standard care, and those randomized to the~     reinforcer arm will receive escalating reinforcement initially for attendance at each clinic~     visit (until month 6 after starting HAART) and subsequently (until month 12 after starting~     HAART) will receive an escalating variable reinforcer for each month in which a plasma viral~     load less than or equal to 100 copies/mL is maintained.~      Our hypotheses are that drug users initiating HAART and randomly selected to receive a~     reinforcer for attending clinic visits then maintaining monthly virologic suppression during~     the first 52 weeks after HAART initiation will be significantly more likely to achieve~     virologic suppression at 52 weeks, will have a significantly longer duration of sustained~     virologic suppression during the first 52 weeks, and will be significantly more likely to~     maintain virologic suppression at 72 weeks after HAART initiation, than those not offered a~     reinforcer.~   "
119714|NCT01488929|"~     Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of~     schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on~     the function, employment, and social interactions of patients with schizophrenia.~     Medications used to treat schizophrenia (e.g. atypical antipsychotics) do not improve~     negative symptoms or CDS. TC-5619 is being developed for use as an add-on therapy in~     combination with atypical antipsychotics to treat patients with negative symptoms and CDS.~   "
119715|NCT01488916|"~     Vitamin D deficiency is associated with an unfavorable metabolic profile in several~     observational studies. However, the influences of vitamin D concentrations on postprandial~     glucose in type 2 diabetes (DM) are less studied. The purposes of the study are to study the~     effects of vitamin D inadequacy on postprandial glucose excursion and metabolic responses in~     patients with type 2 DM. This is a cross-sectional study. About 150-180 patients will be~     screened for serum levels of 25(OH)D. A total of 45 eligible patients will be grouped into~     three groups by different vitamin D status: vitamin D deficiency, vitamin D insufficiency,~     and the controls. The patients will receive a mixed meal test for postprandial glucose~     excursion and metabolic responses. The investigators will use statistical methods to assess~     the differences in post-challenge glucose and metabolic response among the three groups of~     patients. The investigators hope the study can explore the relationship between vitamin D~     and glucose excursion in patients with type 2 DM.~   "
119716|NCT01488903|"~     Not many studies examined genetic determinants of obesity in women. As pre-menopausal and~     post-menopausal women appear to have different propensities for fat deposition, genetic loci~     linked with obesity-related phenotypes might be different by menopausal status. So far,~     there is no large scale of genetic study deciphering common obesity focusing on women~     population to examine the contributions of aging and change in menopausal status to obesity~     in Taiwan. The investigators propose this study to compare phenotypic profiles of obesity~     and cardio-metabolic factors in pre-menopausal and post-menopausal women. The study will~     examine the contributions of aging and change in menopausal status to the changes of~     obesity-related traits during the transition from pre-menopause to post-menopause period,~     and will evaluate the contribution of genetic susceptibility on body fat deposition among~     women at different stage of menopause.~   "
119717|NCT01488890|"~     The aim of this study is to evaluate the administration of CYD dengue vaccine following a~     compressed schedule in different populations.~      Primary Objectives:~        -  To describe the humoral immune response to each of the 4 parental dengue virus~          serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in defined study~          groups.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in defined study~          groups.~      Secondary Objective:~        -  To describe the humoral immune response to each of the 4 parental dengue virus~          serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in defined~          study groups, irrespective of whether or not Yellow fever (YF) vaccine has been~          previously administered.~        -  To describe the YF humoral immune response at baseline and 1, 3, and 7 months after~          injection of the YF vaccine at Month 0 in Groups 3 and 4.~        -  To describe the safety profile in terms of solicited injection site and systemic~          events, unsolicited adverse events and serious adverse events after each injection of~          CYD dengue vaccine and/or YF vaccine.~   "
119718|NCT01488877|"~     PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary~     purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of PF-03882845 in this population.~   "
119719|NCT01488864|"~     The objectives of this study are to compare frequency and severity of moderate to severe~     vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an~     untreated control-group (CG) and to investigate if Health Related Quality of Life improve in~     the AR-group compared to an untreated CG.To study if salivary cortisol excretion would~     change within the AR treated group compared with the control group.~   "
119720|NCT01488851|"~     Prospective observational multi central cohort study to assess the incidence of osteo~     necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment~   "
119721|NCT01488838|"~     A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus~     Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors~   "
119722|NCT01488825|"~     The present study was designed to evaluate effect of yoga intervention on patients having~     frequent tension type headache.~   "
119723|NCT01488812|"~     This study investigates the relationship between waiting time to surgery and the risk for~     medical complications and 1-year mortality in hip-fracture patients.~   "
119726|NCT01488773|"~     The objective of the study was to compare in real life clinical practice two treatment~     regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid +~     montelukast.~   "
119727|NCT01488760|"~     The purpose of this study was to evaluate feed-forward contraction of the transversus~     abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus~     externus during calm and standardized respiration in low back pain patients and pain-free~     subjects.~   "
119728|NCT01488747|"~     The primary objective of this investigation is to determine the relative percentage and rate~     of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total~     omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil~     supplements versus an encapsulated triglyceride in defined plasma lipid pools.~      The primary endpoints to be evaluated include the fatty acid composition of plasma lipids~     before and after consumption of a single dose of emulsified triglyceride based fish oil and~     triglyceride of similar n-3 compositions in capsule form. The investigators will measure~     changes in plasma phospholipid, and chylomicron fatty acids.~   "
119729|NCT01488734|"~     The purpose of this study is to compare the safety and efficacy of two different amounts of~     vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the~     daily meals versus same doses of vitamin D3 provided as oral supplements sold in any~     drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D~     deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic~     syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for~     heart disease and other health problems, such as diabetes and stroke as described by the US~     department of Health and Human Services.~      This study will also attempt to demonstrate and compare the effect of the intervention with~     above two doses of vitamin D on blood levels of tests that show inflammation.~   "
119730|NCT01488721|"~     The purpose of this study is to assess the agreement of clinical performance between the~     proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in~     newborn screening programs for detection of T4, TSH, 17-OHP and IRT.~   "
119731|NCT01488708|"~     The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399~     in eligible SLE participants who have completed the core studies (NCT01196091)~     (NCT01205438).~   "
119732|NCT01488695|"~     A new GlideScope videolaryngoscope has been developed, which utilizes a track on the~     superior surface of the blade to guide the endotracheal tube, which is advanced in the track~     as opposed to free-hand along the inferior surface, where the camera is located. This new~     GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators~     hypothesize that this GlideScope will be easier to use than the Macintosh blade.~   "
119733|NCT01488682|"~     Recently, the HS has been used in head and neck surgery as an alternative to conventional~     hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have~     been published on the evidence of its safety in ND, especially in radical ND. Researchers~     investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND),~     while using conventional hand-tied ligation to a minimum, in terms of operating time, blood~     loss, drainage and complications.~   "
119734|NCT01488669|"~     In this study we introduce and evaluate the feasibility of our surgical technique to hide~     the external scar of neck dissection using the robotic system via a modified facelift or~     retroauricular approach.~   "
119735|NCT01488656|"~     This study will determine if a comprehensive antioxidant/anti-inflammatory dietary~     supplement pack can offer protection against a decline in lung function and increase in~     inflammation and oxidative stress following acute exposure to particulate matter air~     pollution with a diameter <2.5 µm (PM2.5).~      The investigators hypothesis is a follows: Compared to an appropriate control,~     supplementation with a comprehensive antioxidant/anti-inflammatory dietary supplement pack~     for 18 weeks will: 1) reduce the decline in lung function following acute exposure to~     naturally occurring elevations in PM2.5 levels as measured by exhaled nitric oxide levels~     and forced vital lung capacity; and 2) reduce changes in pro-inflammatory cytokines~     following acute exposure to naturally occurring elevations in PM2.5 levels as measured by~     plasma levels of C-reactive protein.~   "
119736|NCT01488643|"~     There is increased frequency of asthma in obese patients. This study is trying to find out~     if there is a difference in the presence of bronchospasm during anesthesia in obese and non~     obese patients.~   "
119737|NCT01488630|"~     The lack of substance screening and referral in healthcare settings is a significant problem~     with far-reaching consequences, including excess morbidity, premature mortality, and~     inflated healthcare costs. An easy to use, time-efficient referral system is needed to~     address this problem. The Substance Treatment Referral Systems (STaRS), a computer assisted~     screening and referral system, was developed to meet this need.~      STaRS Phase I demonstrated the feasibility of STaRS to meet this need. All aims and~     evaluation goals of the Phase I study were met or exceeded. The purpose of the Phase II~     research is to demonstrate the clinical utility and commercial viability of STaRS.~      Specific Aims of Phase II are:~        1. Integrate STaRS with the Epic electronic health record used in the Cooper Health System~          in Camden, N.J.~        2. Document STaRS' effectiveness in (a) increasing the number of referrals provided for~          substance abuse treatment and HIV screening, and (b) increasing the proportion of~          patients that initiate specialty treatment.~        3. Evaluate clinician acceptance and impact upon revenue generation.~      The research will be conducted at Cooper Family Medicine (CFM) department of Cooper~     University Hospital in New Jersey. We will determine the rate of referrals and treatment~     initiation for 3,500 adult patients treated during treatment as usual (the time before STaRS~     is implemented at CFM) as well as 3,500 adult patients treated after the introduction of~     STaRS. Patients will be asked about the referral initiation process, and CFM healthcare~     providers will be asked to evaluate the system from a clinical and administrative~     prospective. Finally, billing records will be reviewed during the STaRS implementation to~     determine whether STaRS impacted revenue for the practices.~   "
119738|NCT01488617|"~     The purpose of this study is to determine whether psychological and social factors in~     addition to medical (physiological) conditions may contribute significantly to the~     prediction of the postoperative outcome.~      Postoperative outcome is defined (1) as postoperative complications and organ dysfunction~     and (2) alteration of quality of life.~   "
119758|NCT01488357|"~     Deciding whether or not to have breast reconstruction after mastectomy is highly challenging~     for many patients. This study will examine patients' decisions about reconstruction and the~     effects of reconstruction on quality of life and body image.~   "
119876|NCT01486823|"~     This is a study in healthy volunteers designed to investigate the PK following intravenous~     and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of~     MLDL1278A after subcutaneous administration will be determined.~   "
119739|NCT01488604|"~     This study will test 200 people to see if an experimental nasal spray has an effect on~     symptoms of the common cold if used when the symptoms start. At the first visit to the~     clinic, potential subjects will have tests to make sure they qualify to participate in the~     study.~      If they qualify, they will have an equal chance of receiving the experimental nasal spray or~     a sham nasal spray (one that does not have the experimental formula). At the first visit,~     subjects will receive their assigned nasal spray and use it once at the clinic. They will~     also receive a booklet called a diary. Subjects will take the rest of their treatments for~     day 1 at home, and for the next six days, they will use the nasal spray four times per day~     and record their symptoms in the diary, as instructed. Then subjects will come back to the~     clinic for a final visit.~   "
119740|NCT01488591|"~     The aim of this study :~        1. Through the study of genes of protein, transporter, translator and epigenome~          investigating the effect of anti-cancer treatment or the key factor of the MDR~          (Multidrug resistance) on the blood cancer patients who are under the anti-cancer sork~          treatment~        2. Giving a service of anticancer medicine therapeutic drug monitoring (TDM) and~          genotyping~   "
119741|NCT01488578|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of~     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety~     and/or efficacy of this drug.~   "
119742|NCT01488565|"~     Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by~     anemia,neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet~     counts). MDS patients with thrombocytopenia who fail standard therapies require regular~     platelet transfusions which are expensive and inconvenient, and are a risk for further~     serious bleeding complications. The new treatment of MDS using azacitidine has shown to~     increase the survival rate of MDS patients including to improve platelet production over~     time. However,in the early cycles of treatment with azacitidine,the low platelet counts tend~     to exacerbate before they provide any clinical benefit.~      Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been~     able to increase platelet counts in healthy Thrombocytopenia Purpura (ITP), a disease where~     patients destroy their own platelets very rapidly and thus develop thrombocytopenia.~      Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved~     for the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to~     standard treatment.~      This study is a single arm pilot study to evaluate the safety and tolerability of~     Eltrombopag in the treatment of low platelet counts in adult subjects with MDS treated using~     azacitidine This study also incorporates a correlative laboratory component designed to~     determined the mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a~     baseline profile which may predict those most responsive. These studies will incorporate~     gene methylation and expression, and immunoprofiling.~   "
119743|NCT01488552|"~     The Investigators in the PCRT team have developed a therapeutic regimen which attacks both~     the tumor compartment and the stromal compartment of pancreatic cancer and induces complete~     responses in a small percentage of patients with advanced stage IV pancreatic cancer.~   "
119744|NCT01488539|"~     Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for~     Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually~     provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will~     be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization~   "
119745|NCT01488526|"~     Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission~     remains a concern and has been reported in approximately 8-15% of infants born to hepatitis~     B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10~     copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior~     observational studies have shown that antiviral therapy including lamivudine or telbivudine~     use during late pregnancy can safely reduce the rate of vertical transmission in this~     special population compared to untreated patients.~      Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and~     normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with~     few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated~     prospectively in this study:~        1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10~          copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.~        2. Its efficacy in the reduction of HBV vertical transmission rate.~   "
119746|NCT01488513|"~     This phase I trial studies the side effects and best dose of ABC294640 in treating patients~     with advanced solid tumors. ABC294640 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Please note that the FDA OOPD is participating as a~     funding source.~   "
119747|NCT01488500|"~     Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common~     air in many parts of the world and previous studies indicate that wood smoke induce~     oxidative stress in the respiratory tract. It is not determined how different types of~     biomass combustion affect human health. In this study the investigators plan to investigate~     how inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.~   "
119748|NCT01488487|"~     The purpose of this study is to estimate the time to disease progression when everolimus and~     pasireotide are given together in patients with advanced or metastatic HCC who have not had~     any prior systemic therapy.~   "
119759|NCT01488344|"~     RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid~     leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of~     BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells.~      PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose~     cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works~     in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II).~   "
119760|NCT01488331|"~     This prospective, multi-center, observational study will assess the progression-free~     survival and safety of patients with locally advanced or metastatic non-small cell lung~     cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months.~     Data will be collected for 24 months.~   "
119749|NCT01488474|"~     The prevalence of diabetes mellitus (DM) in industrialized countries is estimated to be~     about 7.3% and its incidence has been growing in recent years. The prevalence of diabetic~     neuropathy in the diabetic patient population is up to 50%. When limb surgery is necessary,~     it is reasonable to assume that diabetic patients will benefit from a peripheral regional~     anesthesia because of the severe comorbidities associated with DM. On the other hand, the~     use of regional anesthesia (RA) has generally not been recommended in patients with~     preexisting neuropathies mainly because of medical liability issues, as worsening neuropathy~     could be attributed to nerve damage caused by the regional anesthetic. The current state of~     the art of peripheral regional anesthesia for the identification of correct placement of an~     injection needle suitably close to the target nerve is to elicit a motor response by current~     injection through the needle. Constant reduction of the current as the nerve is approached~     ensures close proximity so that an effective nerve block is obtained when the local~     anesthetic is delivered through the needle, and absence of a motor response at 0.3 mA is~     generally accepted as a safety marker to avoid harmful intraneural injection. An important~     deficit in our understanding is whether diabetic neuropathy influences the stimulation~     parameters for peripheral nerve stimulation (PNS), possibly decreasing safety.~      The currently proposed research is guided by the hypothesis that nerves in patients with DM~     are more resistant to stimulation and the current thresholds for PNS have to be set much~     higher to prevent injections from occurring within the epineurium. The investigators will~     examine the effect of DM on nerve excitability in a blinded, prospective, observational case~     control trial. Accordingly, the investigators have defined following aims:~      Specific Aim 1: To characterize the required stimulation current in patients with and~     without diabetes mellitus.~      Specific Aim 2: Follow-up to examine if the rate of adverse neurologic events is higher in~     diabetic patients.~      Specific Aim 3: Guided by the results, formulate recommendations for the performance of~     regional anesthesia in patients with a history of DM.~      These experiments will provide better understanding of the needle-current-nerve relationship~     during peripheral nerve stimulation. Findings from this study will have a major impact on~     patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional~     anesthesia.~   "
119750|NCT01488461|"~     Congenital ataxias (CA) are rare, non progressive diseases, characterized by psychomotor~     retardation, hypotonia followed by ataxia. The presence of the molar tooth on MRI allowed~     to define Joubert syndrome, a peculiar form of CA. Apart from this group, CA are mostly~     associated with cerebellar atrophy or hypoplasia without molar tooth on MRI. CA are a~     clinically as well as genetically heterogeneous group of diseases. Early-onset ataxias are~     progressive but may be difficult to distinguish from CA in the first years of the disease.~     To date, few genes responsible for CA have been identified: ABC7 (X-linked CA associated~     with sideroblastic anemia), SLC9A6 (X-linked CA associated with severe mental retardation,~     autism and epilepsy), GPR56 (CA associated with polymicrogyria), ATCAY (pure CA in Cayman~     isolate); the involvement of the ATCAY and ABC7 genes has never been assessed in a large~     cohort of CA patients.~      Primary objective:~      To assess the frequency of mutations of the ATCAY and ABC7 genes in patients affected with~     non Joubert congenital or early-onset ataxia.~      Secondary objective:~      To identify new loci and/or genes responsible for CA To further describe the clinical~     phenotype of the CA and to assess the frequency of the various clinical types (pure CA/CA~     associated with spasticity/ syndromic CA, congenital/early-onset CA, sporadic/familial CA).~      To describe the clinical phenotype of CA related to mutations in one of analysed genes.~   "
119751|NCT01488448|"~     The purpose of this study is to determine if nebulized hypertonic saline (or extra salty~     water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad~     chest colds) get better enough to be discharged from the hospital sooner than those infants~     given nebulized normal saline (or regular salty water mist).~   "
119752|NCT01488435|"~     The purpose is to determine if the consumption of study product has an effect on acute~     respiratory infections and/or diarrheal disease.~   "
119753|NCT01488422|"~     This study will identify neural mechanisms associated with changes in emotion regulation~     following participation in stress reduction programs.~   "
119754|NCT01488409|"~     The purpose of the study is to examine whether a medication called acipimox can improve your~     body's mitochondria. Mitochondria are the power house of the cell and make energy for your~     body.~      Obesity is associated with increased risk for developing diabetes. However, the~     investigators do not know how obesity leads to diabetes. Previous studies have shown levels~     of fat in the blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can~     affect how our body uses glucose and responds to insulin. Recent studies have shown that~     changes in mitochondria may be involved in the development of diabetes and may be affected~     by FFA. The investigators propose to improve the function of mitochondria in obese people~     with pre-diabetes by treating with acipimox, a medication which decreases FFA. The~     investigators will use state of the art techniques to evaluate the mitochondria, including a~     new magnetic resonance imaging (MRI) technique to measure function of mitochondria in~     muscle.~   "
119755|NCT01488396|"~     The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic~     emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by~     subjective symptoms and signs.~   "
119756|NCT01488383|"~     A natural sweetener (Stevia Rebaudina Bertoni) reduces blood glucose levels and blood~     pressure according to various preclinical and clinical studies conducted worldwide. Since it~     is not found many studies in the literature wich compares Stevia Rebaudiana with saccharin,~     we've proposed a randomized crossover clinical trial comparing the effects on postprandial~     capillary blood glucose and blood pressure in healthy adults.~      Sample: healthy professionals from two health centers in Alava (Kakuabizkarra primary care~     center and Txagorritxu hospital). Inclusion criteria: Professionals of two health centers of~     Álava (Lakuabizkarra and Txagorritxu) and active employment status at the beginning of the~     trial, weighing more than 50kg and age over 18 years.~      Intervention: 200mg capsules of Stevia or 250mgcapsules of saccharin. Measurements:~     Capillary blood glucose and blood pressure, fasting and after eating. Evaluation of satiety,~     hunger and fullness by questionnaire after intake, and at the end of the day.~      Statistical analysis: Compare the postprandial capillary glucose levels between 8 am and 1~     st hour, 2nd hour 3rd hour after intake between treatments by ANCOVA. We will also compare~     blood pressure before and after intake between treatments. We will also compare by t test or~     paired Wilcoxom (depending on the nature of the variable) the results of the questionnaire~     after intake between treatments.~   "
119757|NCT01488370|"~     This is a prospective randomized clinical study to be performed in pediatric patients under~     the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation.~     Time to endotracheal intubation will be compared between patients intubated using a~     GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and~     those intubated by standard direct laryngoscopy. The study hypothesis is that the time to~     endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when~     compared to the GlideScope® video laryngoscope group and standard laryngoscopy.~   "
119762|NCT01488305|"~     Helen Keller International (HKI), the ministry of health and population, and ministry of~     agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO)~     partners are currently implementing a USAID funded Action Against Malnutrition Through~     Agriculture (AAMA) project in Baitadi district located in far Western development region of~     Nepal. HKI is undertaking this study within the AAMA project to test whether providing~     micro-nutrient powders (MNPs) in a programmatic context along with homestead food production~     (HFP) and an intensive community level Infant and Young Child Feeding Behavior change~     communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and~     improving growth in young children than only providing the HFP and IYCF-BCC intervention~     without MNPs or a control with no intervention.~   "
119763|NCT01488292|"~     This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special~     education students in behavioral classrooms. The program includes multiple service~     components: the RECAP classroom mental health curriculum, which develops students'~     behavioral and social skills; reading intervention; individualized skills training; and~     parent group. Schools are randomly assigned to the treatment or control group. This two-year~     multi-component mental health and academic intervention is hypothesized to improve students'~     mental health, social skills, and academic functioning.~   "
119764|NCT01488279|"~     The investigators hypothesize that sitagliptin will significantly reduce impairments in~     insulin secretion and insulin resistance resulting from short-term oral glucocorticoid~     therapy.~   "
119765|NCT01488266|"~     The objective of this study is to compare the efficacy and safety of aripiprazole as~     adjunctive therapy versus switching to different class of antidepressants for treating major~     depressive disorder partially or minimally responsive to ongoing antidepressant treatment.~   "
119766|NCT01488253|"~     Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a~     graft-versus-host disease prophylaxis, the investigators are going to perform a phase II,~     multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral~     blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116~     patients will be accrued.~      Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD.~     Secondary objectives include the time to neutrophil and platelet engraftment, the incidence~     of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant,~     mucositis severity, all infectious complications including cytomegalovirus (CMV)~     reactivation, vascular complications (venoocclusive disease of liver; VOD, thrombotic~     microangiopathy; TMA), disease-free survival, and overall survival at 1 year after~     transplant.~      Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute~     leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate~     organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I~     HLA-A and B and molecular Class II DRB1 must be matched.~      Treatment Description: Conditioning regimens will vary by center and donor will donate~     peripheral blood stem cells according to local institutional practices. Peripheral blood~     stem cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be~     administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with~     a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral~     loading dose on day -1, followed by a 3 mg/day single dose, with a target serum~     concentration of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and~     then as clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent~     dose prior to discharge and both immunosuppressives will be tapered beginning at day +100~     after transplantation and eliminated by day +180 when clinically feasible.~      Accrual Period: The estimated accrual period is three years. Patients will be followed for~     100 days post transplantation for evaluation of the primary endpoint, with additional~     follow-up to two years after transplantation for evaluation of secondary endpoints.~   "
119767|NCT01488240|"~     The purpose of this study is to determine the effects (good or bad) of pulsed dye laser~     treatment in burn scar height, texture, redness and pliability in acute burn injury.~   "
119768|NCT01488227|"~     Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce~     injuries and illnesses, and improve performance in collegiate swimmers and divers.~      Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course~     of the intervention period.~   "
119769|NCT01488214|"~     Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This~     disease is usually thought to spare central nervous system. However, neuropsychiatric~     manifestations like depression and cognitive functions impairment seem to be frequent.~     Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter~     hyperintensities have been reported suggested CNS vascular manifestations in systemic~     sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric~     manifestations in systemic sclerosis is unknown. The primary objective of this prospective~     and multicentre study is to assess a link between neuropsychiatric manifestations and CNS~     involvement in systemic sclerosis. Secondary objectives are to assess the frequency of~     neuropsychiatric manifestations, to compare central nervous system abnormality between~     scleroderma patient and healthy subjects. Central nervous system involvement and~     neuropsychiatric manifestations will be systematically assessed through central nervous~     system imaging and questionnaires.~   "
119770|NCT01488201|"~     This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate~     safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous~     administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.~   "
119771|NCT01488188|"~     Background: It is well established that live attenuated organisms can be highly effective~     vaccines, immune responses elicited can often be of greater magnitude and of longer duration~     than those produced by non-living antigens and are often able to confer protection after a~     single dose. Unlike killed influenza vaccine preparations injected by the parenteral route,~     live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses~     in the airway mucosae and can also evoke cell mediated responses. T cell proliferation,~     cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity~     have all been elicited by live attenuated vaccines.~      There has been a history of the use of live attenuated flu vaccines as safe and effective~     vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted~     influenza vaccines have been proved to be highly efficacious to protect against clinical fly~     symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has~     been approved by the US FDA. Recent side by side clinical trials have demonstrated that this~     nasal vaccine was significantly superior to conventional killed flu vaccine in protecting~     against flu symptoms.~      Sublingual administration of live influenza virus at a dose lethal by the nasal route was~     well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent~     Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of~     recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found~     to be safe.~      A major issue has arisen regarding the ease with which vaccines could be administered to~     young children, especially infants, and to elderly subjects in whom nasal vaccination has~     not been possible and/or approved due to difficulties of administering nasal vaccines in~     infants and to undesired side effects related to frequent rhinitis and sneezing episodes in~     elderly subjects. This study is designed to investigate the safety, tolerability and~     immunogenicity of a new route of administration of vaccines, using the nasal FluMist~     formulation as prototype vaccine.~      Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza~     virus vaccine (FluMist) in healthy adult volunteers~      Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will~     receive vaccine via nasal and sublingual route, respectively~   "
119774|NCT01488149|"~     Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One~     potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal~     blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding~     behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous~     feeding behavior during the first days of life is a significant predictor of long-term~     breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study,~     neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when~     mothers received >150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean~     umbilical cord fentanyl concentration was significantly higher in the >150 mcg versus <150~     mcg group.~      The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly~     associated with decreased breastfeeding rates at hospital discharge and with neonatal~     deficits in latching onto the breast and swallowing during the first three hours of life,~     and that a significant dose-response relationship exists with respect to total micrograms~     fentanyl infused.~      The investigators will perform a prospective cohort study of all parturients age 18+ at~     UHCMC over a three-month period, excluding those with multiples gestation, Cesarean section,~     or neonatal intensive care unit admission. From patient charts, the investigators will~     record the following variables: number of neonates delivered; type of delivery (spontaneous~     vaginal / operative vaginal / Cesarean section); whether the neonate was admitted to the~     intensive care unit; the mother's age, height, weight, gravity, parity, intention to~     breast-feed at the time of hospital admission, number of children previously breast-fed, and~     ethnicity; gestational age at the time of delivery; administration of oxytocin for labor~     augmentation and in what quantity; duration of active labor; antibiotic administration;~     neonatal APGAR scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were~     administered before and/or after the delivery and at what exact time. We will also record~     whether each patient received an epidural during labor and, if so, the duration of this~     epidural infusion and the total micrograms fentanyl delivered; neonatal feeding behavior as~     quantified by the LATCH scores assigned to each breast-feeding interaction that occurs on~     the postpartum care floor; whether the mother is breast-feeding her baby at the time of~     discharge from the hospital, and if not, then her primary reason for not doing so (as~     communicated during the standard postpartum lactation consultation); and how long mother and~     baby stayed in the hospital post-delivery.~   "
119775|NCT01488136|"~     The investigators know that intensive insulin therapy and tight glucose control is~     associated with reduction of diabetic complications. However, many patients on insulin don't~     achieve this because of the risk and the fear of hypoglycaemia (too low blood glucose).~      There has been a lot of work done recently looking at the mechanisms by which the brain~     detects hypoglycaemia. A key player is a potassium channel in the brain (KATP channel).~     Studies have shown that when these channels are opened, there is a release of hormones such~     as adrenaline that can help in raising blood sugars to counteract and increase awareness of~     hypoglycaemia. The investigators study aims to look at an old drug called diazoxide, which~     is able to open KATP channels.~      The investigators aim to see if diazoxide will amplify the release of hormones such as~     adrenaline when the blood sugar is low. If this is the case, this will aid quicker recovery~     following hypoglycaemia.~      The investigators aim to do this by performing a well established experimental protocol that~     has been performed safely over the last 20 years called a clamp study. The clamp study will~     involve slowly bringing the blood sugars down using insulin and intravenous glucose in a~     controlled fashion. The main outcome will be the hormonal responses (adrenaline response) at~     a blood sugar level of 2.5mmol/L. Symptoms of hypoglycaemia will be monitored, as well as~     working memory tests using standardised questionnaires.~      The design of the investigators study will be a randomised trial comparing the effects of~     diazoxide with placebo in which all patients will receive both diazoxide and placebo in~     random order (crossover design).~   "
119776|NCT01488123|"~     The purpose of this study is to determine whether a four-month manualized Ayurvedic~     intervention will improve quality of life in recent breast cancer survivors.~   "
119777|NCT01488110|"~     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of~     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,~     and presence of a preventive effect two months post treatment. Another purpose is to~     investigate if and how this treatment affects manifestations of the autonomic nervous system~     activity.~   "
119778|NCT01488097|"~     This is an extension study to the first clinical study of SBC-102 (sebelipase alfa) for the~     treatment of LAL Deficiency. It is an open label study in adult patients with liver~     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency. This study will assess the~     long-term safety, tolerability, and efficacy of SBC-102. The targeted number for this study~     is 9 evaluable subjects.~   "
119779|NCT01488084|"~     The purpose of this study is to compare saphenous veins harvested using the atraumatic~     pedicled (no-touch) technique to saphenous veins harvested using the conventional open~     technique in patients undergoing isolated coronary artery bypass surgery. Investigators will~     compare the biological structure of the saphenous veins harvested using these two~     techniques. There is some evidence that saphenous veins harvested using the no-touch~     technique may allow for better patency up to 8 years following bypass surgery. We may be~     able to detect early differences in vascular structure, observed at the time of conduit~     harvest.~   "
119780|NCT01488071|"~     The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is~     at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms~     that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.~   "
119781|NCT01488058|"~     Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in~     the maintenance of disorders. One specific bias is the interpretation of ambiguous~     information. A negative interpretation bias is defined as a systematic tendency to interpret~     potentially ambiguous information in a negative rather than benign way and this bias has~     been associated with symptoms of depression. Research has led to the recent development of~     computerized cognitive bias modification (CBM) techniques to augment such biases and it has~     been suggested that CBM techniques may be useful as an adjunct to current treatments to~     enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM~     procedures lend themselves to being delivered remotely, are cost-effective, and can be~     self-paced in ways that suit the patient make them an ideal candidate for inclusion in the~     Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St.~     Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the~     current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to~     the existing iCBT modules offered through St. Vincent's Hospital and the University of New~     South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as~     indexed by a standardized clinical battery.~   "
119782|NCT01488045|"~     The study aim is to determine if Propofol or the combination of Fentanyl and low-dose~     Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a~     colonoscopy. This is a prospective randomized study of 262. The primary outcome of this~     study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived~     by the participant, and the secondary outcome will be the discomfort of the patient and~     difficulty of the procedure as perceived by the physician.~   "
119785|NCT01488006|"~     This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study~     are to establish the safety, effectiveness, and value of the prosthetic system, and to~     collect information from expert shoulder surgeons as to features of the implants,~     instruments, and techniques which may be further improved. In this study, the investigators~     hypothesize that this prosthetic device will significantly improve long-term patient-based~     outcomes, functional status and quality of life.~   "
119786|NCT01487993|"~     The purpose of this study is to determine whether metformin is effective in reducing BMI and~     insulin resistance in obese children and adolescents.~   "
119787|NCT01487980|"~     Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3~     min after delivery) is effective in increasing (low birth weight) infant haemoglobin and~     iron status until six months after birth, without increasing the risk of polycythaemia or~     other adverse events. We hypothesize that this intervention will also benefit low birth~     weight infants in South Africa.~   "
119788|NCT01487967|"~     This pilot intervention study will test the feasibility and acceptability and explore the~     outcomes of an urban, primary care-based intervention to measure families' preferences and~     goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical~     care to reach these goals.~   "
119789|NCT01487954|"~     This phase II trial is studying how well alkaline water works in reducing skin toxicity in~     women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation~     therapy-related skin toxicity in patients with breast cancer.~   "
119790|NCT01487941|"~     The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead~     Setrox JS.~   "
119791|NCT01487928|"~     Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies~     show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly~     affect an infant's growth. The investigators now have the ability to measure caloric density~     of human milk and add human milk cream to any human milk (mother's own or donor human milk)~     that is less than 20 kcal/oz to bring it up to that amount.~   "
119792|NCT01487915|"~     Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.~      But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.~      Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb)~     with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred~     regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.~      But the grade 3 or worse toxicities associated with GCb are not infrequent and need more~     effective and more tolerable regimens.~      GemOx has been reported to be effective and have very favorable toxicity profiles.~   "
119793|NCT01487902|"~     The purpose of this study is to assess the androgen deprivation therapy when patients with~     castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.~   "
119794|NCT01487889|"~     Primary objective of this study is to examine the effects of 2 different approaches of~     dietary strategies to optimise fatty acid composition in complementary food on infant's~     fatty acid status and its consequences on cognitive and visual development.~      Subjects are randomly assigned to one of three groups:~        -  Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3~          LC-PUFA metabolism)~        -  Fatty fish (preformed n-3 LC-PUFA, especially DHA)~        -  Corn oil (as control group, high in n-6 PUFA, common in complementary food).~      The intervention starts with the beginning of complementary feeding as generally recommended~     between 4 to 6 months of age and ends at the age of 10 months. For this period of time~     subjects of all groups receive commercial vegetable-potato-meat-meals as part of~     complementary food which only differs in the fatty acid composition.~   "
119795|NCT01487876|"~     In order to study the immunotherapeutic effects of electroporation (EP)-mediated~     dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a~     double-blind, randomized, placebo-controlled trial, approved by Chinese State Food and Drug~     Administration with written informed consent from each chronic hepatitis B (CHB) patients~     with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and~     who were under the simultaneous lamivudine (LAM) chemotherapy.~   "
119796|NCT01487863|"~     The purpose of this study is to evaluate the impact of concurrent versus sequential~     administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T,~     and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential~     administration of abiraterone acetate plus prednisone in men with metastatic castrate~     resistant prostate cancer.~   "
119797|NCT01487850|"~     On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the~     investigators supposed that wind reed instruments could be contaminated with molds. The~     investigators led a study on 40 musicians playing a wind reed instrument to analyze~     instruments' fungal contamination and its immunological and clinical consequences for~     musicians.~   "
119798|NCT01487837|"~     The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger~     levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the~     treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study~     hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF~     < 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours~     after start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.~   "
119799|NCT01487824|"~     The purpose of this study is to investigate whether early life exposures such as premature~     birth or exposure to preeclampsia before you are born results in long-term alterations in~     the cardiovascular system that increase risk of cardiovascular disease development.~   "
119800|NCT01487811|"~     This trial is conducted in the United states of America (USA). The aim of this trial is to~     compare two formulations of biphasic insulin aspart 30 in healthy volunteers.~   "
119801|NCT01487798|"~     This trial is conducted in Europe. The aim of this trial is to investigate the difference in~     frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30~     compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.~   "
119916|NCT01486303|"~     Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the~     face, head and neck. This study is designed to determine the efficacy and safety of Facial~     Cosmetic Acupuncture on skin rejuvenation.~   "
119802|NCT01487785|"~     This phase Ib study includes two phases: dose escalation phase and safety expansion phase.~      During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and~     maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225~     administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase~     of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for~     expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced~     or metastatic pancreatic adenocarcinoma patients.~      During the safety expansion phase, once the MTD of LDE225 is established, additional~     patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine~     in order to further evaluate its safety, tolerability and explore the potential efficacy of~     the combined treatments on the patients in locally advanced or metastatic pancreatic~     adenocarcinoma.~   "
119803|NCT01487772|"~     The aims of the studies are to examine the impact of delayed time to surgery for~     hip-fracture patients with regard to in-hospital complication rate and one-year mortality~     and to evaluate two different fast-track systems for hip-fracture patients with regard to~     patient outcome, complication rate and patient satisfaction.~   "
119804|NCT01487759|"~     The purpose of this study is to investigate the influence of the prebiotic oligofructose~     enriched inulin on the metabolite pattern in Crohn's disease patients.~   "
119805|NCT01487746|"~     The investigators expect to find higher levels of both classical and minor antiphospholipid~     (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not~     only classical APLA but also minor antibodies.~      The investigators believe that minor antibodies have a major role in the hypercoagulability~     state.~   "
119806|NCT01487733|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.~   "
119807|NCT01487720|"~     Prostate cancer is one of the most common malignancies affecting men all over the World.~     Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25~     months). Prostate cancer that grows despite castrate levels of testosterone and that no~     longer responds to any form of hormonal manipulation is defined as castrate resistant~     prostate cancer (CRPC).~      Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response~     in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not~     been universally effective, and nearly all patients have disease progression after docetaxel~     treatment.~      After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone,~     which are not widely and easily availabe in Korea, little treatment regimen can be applied~     to the patients with reasonable response and benefits.~      Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors.~     When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with~     median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in~     pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of~     57% in patients with measurable disease.~      Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of~     activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II~     study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either~     alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including~     cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients~     in each arm.~      Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe~     and effective in various cancers.~      This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.~   "
119808|NCT01487707|"~     The objective of this cluster randomized controlled trial is to assess the impact of several~     community-based interventions that address the key factors underlying the high maternal~     mortality, as well as neonatal mortality and morbidity in northern Nigeria. The~     interventions, include:~        1. a Voluntary Health Worker Program (VHW)~        2. the VHW program with provision of a safe birth kit~        3. the VHW program with community folk media activities.~   "
119809|NCT01487694|"~     Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat~     menopausal symptoms. To date, there are still scarce information about its efficacy in Thai~     women with menopausal symptoms. The purpose of this study will assess the efficacy of black~     cohosh extract in management of menopausal symptoms in Thai women.~   "
119810|NCT01487681|"~     Human papilloma virus (HPV) infection contributes as a main causative factor to the~     development of invasive cervical cancer (ICC) and its precursors (cervical intraepithelial~     neoplasia, CIN). Currently, two prophylactic vaccines are employed for the prevention of~     genital HPV infection. As the prophylactic efficacy is type-restricted, determining the~     type-specific HPV distribution and their associations with ICC and its precursors would~     provide essential information in assessment of HPV vaccination program impact. The baseline~     information is also important for monitoring possible changes in type-specific HPV~     distribution after vaccination has been introduced.~      Prevalence of HPV infection varies considerably across the world, and data were limited from~     less-developed countries. Knowledge of the detail pattern of HPV type-specific distribution~     in each region will be essential for public health policy decisions. This will also form the~     basis for determining which types should be included in future generation HPV vaccines~     targeted to specific regions.~      While most studies were focus on ICC and high-grade cervical lesions, the association~     between HPV types and the progression of CIN1 has rarely been studied. CIN1 is an~     insensitive histopathological sign of HPV infection, most of which will spontaneously~     regress to normal with host immune system. However, some genotypes have been described as~     being more persistent and associated with progression from low-grade lesions to high-grade~     lesions, even ICC. Geographical data on type-specific prevalence of HPV in CIN1 with~     appropriately designed prospective studies would be helpful in identifying types~     preferentially associated with progression to malignancy and accurately predicting the~     future impact of vaccination in specific regions.~      Free vaccination supported by the government appears to be unlikely at present in China.~     Thus, individuals need to pay the cost of vaccines for themselves presently. Yangtze River~     Delta Area is the most economically developed regions in China, and people here may become~     the largest vaccinated population at their own expense in China. To the best of the~     investigators knowledge, no multi-center study on HPV type-specific distribution and their~     associations with ICC and its precursors is available in Yangtze River Delta Area, China,~     which highlights the need for timely study in this region before large scale vaccination~     programs are carried out.~   "
119811|NCT01487668|"~     Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease~     (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to~     help promote health behavior change and improve mental health and physical health-related~     quality of life, as well as to get feedback from patients and providers on what is needed to~     help better coordinate the physical and mental health care of these patients.~   "
119824|NCT01487499|"~     This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung~     cancer in two fashions:~        1. to implement a prospective clinical trial to test the feasibility and efficacy of~          intralesional chemotherapy as consolidative therapy immediately following standard~          systemic chemotherapy and radiation therapy for patients with limited stage SCLC by~          comparing tumor growth and survival rates of the treatment group and compare the~          outcomes to historical controls~        2. to implement a prospective clinical trial to test the feasibility and efficacy as~          measured by tumor growth and survival rates of intralesional chemotherapy for patients~          with recurrent SCLC after standard treatment.~   "
119812|NCT01487655|"~     Color Doppler Imaging (CDI) has been providing information about ocular blood flow over the~     past decades. This non-invasive procedure based on ultrasound technique has identified~     increased resistance and decreased systolic blood velocities to exist in the ophthalmic~     arteries of glaucoma patients. However, existing data has provided very little information~     regarding the analysis of the Doppler waveform in itself and to whether variables such as~     early systolic acceleration or systolic/diastolic velocity ratios are of any significance in~     glaucoma disease. In other medical specialties using CDI technology, such as nephrology or~     cardiology for instance, this analysis has been part of the normal routine. This information~     has been used in screening patients for disturbed circulation such as arterial stenosis or~     providing information regarding prognosis of renal and hepatic transplants have been used~     for decades now.~      What is the normal characteristics of the waveform Doppler analysis? To answer this, the~     investigators will create a normative database using healthy controls.~      Are there signs of altered stiffness or compliance in the ophthalmic arteries of glaucoma~     patients? To answer this, the analysis of early acceleration acceleration and detection of~     an early peak systolic will be done on the Doppler curves of glaucoma patients and compared~     to the healthy normative database.~      Are there any difference between the two types of glaucoma [primary open-angle glaucoma~     (POAG) and normal-tension glaucoma (NTG)]? The investigators will compare the variables of~     the ophthalmic artery waveform in these two groups.~      Do any of these Doppler waveform variables have any clinical significance? To answer this,~     the investigators will search for the existence of any correlation between the waveform data~     and both functional (visual field testing) and structural (Confocal scanning laser~     ophthalmoscopy - CSLO) variables of the glaucoma groups.~   "
119813|NCT01487642|"~     The primary objective of the study is to compare the efficacy of four different smoking~     cessation programmes, including a proactive telephone counseling intervention, a reactive~     telephone counseling a and an interactive web-based intervention and (as control) written~     self-help material.~   "
119814|NCT01487629|"~     The purpose of this study is to compare the morphological and visual acuity outcomes~     associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for~     treatment of diabetic macular edema.~   "
119815|NCT01487616|"~     Aims: We plan to investigate how common uterine malformations are in high-risk women (with~     history of miscarriage or preterm delivery), by analysing different characteristics in these~     groups. This study will also investigate other ultrasound characteristics detected on these~     women. This study will point towards the possible mechanism of how uterine malformations may~     affect pregnancy outcomes.~   "
119816|NCT01487603|"~     Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is~     fewer than 10% and the effectiveness of conventional chemotherapy is limited. The new~     knowledge shows the correlation between genetic alteration and effective of chemotherapy.~     Therefore non-surgical modalities to obtain tumor specimens for genetic alteration analysis~     are particularly critical in lung cancer, since many patients have advanced disease at the~     time of first presentation, and are therefore not eligible for radical surgery.~     Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples~     obtained during diagnosis of lung cancer can be used for molecular analysis that will~     predict response to treatment and prognosis. In this study, we will detect specific target~     molecules related to the effectiveness of treatment (surgery, chemotherapy, radiotherapy)~     and prognosis in patients with lung cancer using EBUS-TBNA samples and its combined with~     xenograft technology.~   "
119817|NCT01487590|"~     For breech presentation, the cesarean section rate is decreased by external cephalic~     version. This is a painful operation, with some rare but serious complications. The aim of~     this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive~     technique, to correct breech presentation before 37 weeks of gestation.~   "
119818|NCT01487577|"~     Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia,~     lymphoma, and other childhood cancers that were once considered incurable. A major barrier~     to the application of this life-saving treatment is acute graft-versus-host disease (GVHD)~     which develops in approximately 30-80% of patients and is a leading cause of death from~     transplant complications. Current GVHD prevention methods are not very efficacious and lead~     to unacceptable side effects. Mycophenolate mofetil (MMF), an anti-rejection medication used~     in solid organ transplants, has shown great promise in BMT recipients. The effectiveness of~     MMF depends on blood levels of mycophenolic acid (MPA, the active form of MMF). Different~     patients have been found to have different blood levels of MPA when they are given the same~     dose of MMF. The purpose of this study is to study a novel method of giving MMF based on its~     metabolism (pharmacokinetics) to achieve desired blood levels of MPA for prevention of GVHD.~     Non-invasive ways of monitoring the drug exposure will also be studied. The ultimate goal of~     this study is to improve approaches to GVHD prevention and improve outcomes of BMT in~     children.~   "
119819|NCT01487564|"~     The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in~     healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.~   "
119820|NCT01487551|"~     The primary objective is to study changes in disease related biomarkers in patients with~     progressive SSc during treatment with ABR-215757.~      The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess~     disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the~     plasma levels of ABR-215757 during the study.~   "
119821|NCT01487538|"~     The purpose of this study is to compare an technology-based weight maintenance intervention~     using action plans, videos discussion boards and health behavior tracking (weight, calories~     in and out, pedometer steps) with a technology-based standard advice group to facilitate~     health management, resourcefulness and health status for rural middle-aged women.~   "
119822|NCT01487525|"~     The purpose of this research study is to determine whether low intensity resistance training~     with concurrent application of a peripheral blood flow restriction device to the exercising~     limb will elicit increased quadriceps strength, functional gains, ability to complete~     knee-related activities of daily living, mobility, and quality of life in individuals at~     risk for developing symptomatic knee osteoarthritis (OA). It is known that higher quadriceps~     strength is protective against developing symptomatic knee OA.1 However, people at risk for~     knee OA frequently do not tolerate the high intensity resistance training that is generally~     believed necessary to increase muscle strength. Partial blood flow restriction (PBFR) to the~     exercising muscle has been reported to result in strength gains, while requiring lower~     levels of joint loading.2 This method may be better tolerated, enabling efficacious exercise~     in older adults who may not tolerate high knee joint loads.~      To asses the efficacy of a 4 week low-intensity resistance training program with concurrent~     application of PBFR to the exercising limbs to improve quadriceps strength and size, leg~     muscle power, and mobility in individuals at risk for developing symptomatic knee~     osteoarthritis,we will test the following hypotheses. In comparison with low-intensity~     resistance training without use of PBFR, a four-week low-intensity resistance-training~     program with PBFR will:~      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee~     extensor strength~      Secondary Hypotheses:~        1. Increase quadriceps muscle volume assessed by MRI~        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed~          stair climb~        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and~          Osteoarthritis Outcome Score (KOOS) questionnaire~   "
119823|NCT01487512|"~     The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in~     healthy adult Taiwanese participants after oral administration of 4 different dose strengths~     of 8, 16, 32 and 64 mg under fasted conditions.~   "
119825|NCT01487486|"~     To the best of the investigators knowledge, exhaustive characterization of the low and high~     abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved.~     Such an analysis may provide critical molecular data on the role of the FF in oocyte~     maturation and may identify specific changes in the FF proteome of patients with gynecologic~     problems, such as Polycystic Ovary Syndrome (PCOS).~      Specific Aims~        1. To perform a comprehensive analysis of normal human FF using sensitive mass~          spectrometry in combination with conventional approaches for proteomic evaluation and~          using HPLC and Western blot for glyco-proteomic analysis.~        2. Characterize differential proteomic and glyco-proteomic patterns of the FF in normal~          women compared to lean and obese women with PCOS.~        3. To supplement the differential proteomic and glyco-proteomic analysis with steroid~          hormone analysis in all FF samples.~   "
119826|NCT01487473|"~     The main purpose of this study is to determine the degree to which Mindfulness-Based Stress~     Reduction, a group-based psychological therapy that includes mindfulness meditation~     exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain~     with daily life among adult chronic pain patients.~      The second purpose is to examine the role of attention in improving psychological and~     physical health for chronic pain patients.~   "
119827|NCT01487460|"~     This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in~     healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311~     concentration in blood and effect of TAP311 administration on simvastatin concentration will~     also be assessed in healthy volunteers.~   "
119828|NCT01487447|"~     The purpose of this study is to determine the efficacy of a customized sound therapy in~     reducing tinnitus loudness and increasing the residual inhibition.~   "
119829|NCT01487434|"~     In partnership with the Chicago Public Schools (CPS), the goal of this project is to test~     the effectiveness of a manualized mentoring and case management program for students in~     grades 1-8. Most of the current policy and research attention on dropout has focused on the~     dropout decision itself, even though dropout is more likely to be simply the end point of a~     longer-term developmental process. This project seeks to learn more about the relative~     effectiveness of preventing dropout through mentoring and case management programs, and to~     learn more about the relative effectiveness of intervening early vs. later.~   "
119830|NCT01487421|"~     This study is conducted in Europe. The aim of this study is investigate the potential of a~     supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled~     patients with type 2 diabetes in a normal diabetes care setting.~   "
119831|NCT01487408|"~     This study is conducted in Japan. The aim of this study is to evaluate the incidence of~     severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or~     type 2 diabetes.~   "
119832|NCT01487395|"~     The early assessment of new drugs for Alzheimer's disease remains difficult because of the~     lack of predictive end-point. The use of a battery including different parameters could~     improve this early development of new drugs. Nevertheless, the interest of such a battery~     should previously be validated with the yet marketed AD drugs~   "
119833|NCT01487382|"~     This study is conducted in Japan. The aim of this study is to collect safety and efficacy~     data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes~     under normal clinical practice conditions.~   "
119834|NCT01487369|"~     This study is conducted in Japan. The aim of this study is to collect data of production of~     insulin aspart specific antibody under normal clinical practice conditions.~   "
119835|NCT01487356|"~     Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy;~     however, few studies have evaluated specific factors that may influence the duration of~     withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection~     rate, one element of quality of colonoscopy, also need further study. By collecting data on~     hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors~     associated with withdrawal time, inappropriately short withdrawal times, and polyp detection~     rate during colonoscopy.~   "
119836|NCT01487343|"~     The purpose of this study is to identify what makes it easier and what makes it harder to~     take oral chemotherapy.~   "
119837|NCT01487330|"~     The purpose of this first-in-human study is to assess the technical feasibility, deployment~     characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and~     delivery system in subjects with severe symptomatic aortic stenosis (AS).~      This is a single center, prospective, non-randomized, first-in-human investigational study~     without concurrent or matched controls.~   "
119838|NCT01487317|"~     The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in~     patients aged 75 and over, hospitalized with delirium.~      Study type : Interventional Study design: randomized, double-blind, placebo-controlled study~     during one month and a 11-month follow-up~   "
119839|NCT01487304|"~     This study is conducted in Europe. The aim of this study is to verify the therapeutic~     effects of low-dose hormone replacement therapy (HRT) in female patients over adequately~     long time period in normal clinical practice conditions in the Czech Republic.~   "
119840|NCT01487291|"~     At the Thrombophilia Clinic of the Hospital Federal dos Servidores do Estado do Rio de~     Janeiro there is a high prevalence of acute psychotic episodes, which allows the~     investigators to raise the suspicion that the thrombotic tendency or hypofibrinolysis play a~     role in the onset of the disease. It is striking that most of these patients, after some~     time on anticoagulants, no longer need to take psychiatric medication.~   "
119841|NCT01487278|"~     This is a large, community-based, cluster-randomized trial to compare routine prophylactic~     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly~     during the third stage of labor.~   "
119842|NCT01487265|"~     Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a~     positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant~     model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control~     was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could~     potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth~     inhibition and enhancing the response to erlotinib.~   "
119843|NCT01487252|"~     An estimated 23 million Americans, including adolescents and the elderly, suffer from~     circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase~     disorder and winter depression. These conditions are characterized by persistent insomnia~     and/or excessive daytime sleepiness, impaired performance, reduced well being and lower~     quality of life. The negative symptoms result from a misalignment between the timing of~     sleep and the internal circadian clock. Clinical research has demonstrated that circadian~     rhythm sleep disorders are most effectively diagnosed (differentiated from other causes of~     insomnia) and treated if each individual patient's circadian phase is known. The timing of~     the master internal circadian clock is most reliably measured from the onset of the~     endogenous circadian rhythm of melatonin, a neuroendocrine hormone, as measured in dim light~     (dim light melatonin onset, or DLMO). However to date the reliable and valid assessment of~     the DLMO is limited to the research laboratory setting.~      This study is to test a streamlined procedure for the accurate assessment of circadian phase~     (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel~     diagnostic and research tool. In this way the underlying neurobiological cause of a~     patient's insomnia and/or circadian rhythm disorder can more readily be diagnosed and~     treated.~      Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample~     of healthy people. Validation will occur by (1) objectively measuring compliance to the~     at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the~     laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the~     same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to~     conduct rigorous analyses to inform future users which subject characteristics and light~     levels predict (1) compliance to the at home procedures and (2) valid at-home DLMOs.~      The results of this 3 year study will have substantial implications for the translation of~     basic and clinical research to the community: (1) the diagnosis and treatment of insomnia~     and circadian rhythm sleep disorders will be significantly enhanced, thus improving public~     health and safety, mood and quality of life, (2) community participation in research will be~     improved, particularly in vulnerable and under represented populations, thus increasing~     scientific knowledge and (3) research and clinical costs will be substantially reduced.~   "
119844|NCT01487239|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion~     study of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or~     surgically sterile female subjects following at least a 10-hour fast from food (not~     including water).~   "
119845|NCT01487226|"~     Purpose Primary endpoint~        -  To evaluate the 3-year disease free survival Second endpoints~        -  To evaluate the 3-year & 5-year overall survival To analyze the toxicity and the~          quality of life~   "
119846|NCT01487213|"~     The main objective of the study is to optimize the routines for follow-up after medical~     abortion in order to give women more autonomy by reducing the number of consultations~     involved and to reduce the frequency of postabortal curettage.~      This will be achieved by providing means for women for postabortal self-assessment with the~     use of a quantitative urinary hCG test.~   "
119847|NCT01487200|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics~     of FX006 in patients with osteoarthritis of the knee.~   "
119848|NCT01487187|"~     Very preterm babies frequently develop problems with their blood circulation during the~     first few days after birth. These circulation problems could affect the oxygen and blood~     flow to their brain and lead to effects such as bleeding in the head or delayed~     developmental milestones later in life. Currently the care for such problems may include~     transfusion of intravenous fluids or blood to the baby and/or giving the baby medications~     that can help circulation.~      The current practice at the delivery of these babies is to immediately clamp their umbilical~     cords after birth. Recent research studies have shown that giving more of the baby's own~     blood to them at birth by delayed cord clamping (waiting for clamping the cord for about~     30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that~     these babies may need later on. It may also improve their initial blood pressure and reduce~     the chances of bleeding in their heads.~      More research is needed to prove if either delayed cord clamping or milking the cord at~     birth will be better in terms of improving these babies' health.~      The aim of this study is to find out if adding some blood to these babies' circulation,~     through milking the cord at birth, could prevent or reduce the possible problems with blood~     circulation and the reduced blood flow to the brain that some of these babies may have after~     birth.~      The investigators will also investigate if milking the cord at birth could improve their~     long-term developmental outcome.~      Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3~     times prior to clamping, compared to immediate clamping after birth will improve systemic~     blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in~     the first 24 hours after birth)~   "
119849|NCT01487174|"~     This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung~     cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is~     hypothesized that KD019 can prolong survival compared with erlotinib.~   "
119850|NCT01487161|"~     The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of FX006~     in patients with osteoarthritis of the knee.~   "
119851|NCT01487148|"~     This study is designed to compare the performance of the P-1000 System, POCARED's Rapid~     Diagnostic System which uses optical fluorescence analysis, to standard methods of~     uropathogen quantification and identification.~   "
119852|NCT01487135|"~     The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and~     supratherapeutic concentrations on cardiac repolarization in healthy subjects.~   "
119853|NCT01487122|"~     This randomised controlled trial aims to compare the effect of microwave diathermy~     (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain~     patients. Every patient will also be treated by exercise and transcutaneous electrical~     neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves~     is justified in terms of pain relief or reduction of disability in this patients.~   "
119854|NCT01487109|"~     This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499~     for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who~     are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI)~     and/or angiotensin II receptor blocker (ARB).~   "
119855|NCT01487096|"~     The primary objective of this study was to determine the safety and efficacy of~     teriflunomide in multiple sclerosis (MS) with relapses.~      Secondary objectives were:~        -  To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI)~          variables as well as clinical and quality of life measures.~        -  To investigate the pharmacokinetic and pharmacodynamic relationships.~   "
119856|NCT01487083|"~     The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in~     participants with schizophrenia.~   "
119872|NCT01486875|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of~     serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects~     with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.~   "
119857|NCT01487070|"~     Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal~     injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy~     in subjects with tractional retinal detachment (with or withoutmacular involvement)~     secondary to proliferative diabetic retinopathy.~      Secondary objective is to evaluate regression of neovascularization and progression of~     macular traction utilizing OCT and fundus photographs.~   "
119858|NCT01487057|"~     The continuous increase of the incidence of the thyroid cancer in the last years has taken~     this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of~     Oncology Prof.Ion Chiricuţă from Cluj-Napoca (IOCN), with a total number of over 470 new~     cases per year, added to the other 3700 cases already being in the evidence of the~     Institute.~      The radical treatment brings for a long term a compensated chronic drug induces mYxoedema~     with it's important side effects. Among these one can find the dislipidemia and the change~     of the high sensitive C reactive protein (hsCRP) serological value. In the last years, many~     epidemiological studies have confirmed the fact that the patients with a high serological~     value of the hsCRP present a higher risk for the coronary disease and heart attack.~      Prospective studies developed in european countries and in USA have provided results that~     are related to the predictive value of the hsCRP determinations over the cardiovascular~     risk. Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for~     cardiovascular disease is 2 to 7 times higher at the people with a high level of hsCRP~     comparing to ones with low levels; the increase of the hsCRP serological value can be~     determined several years before the clinical debut of the coronary disease.~      The screening for this population group with a high risk can introduce in use the prevention~     of the cardiac pathology and change the approach to the monitoring of the patients with~     thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw~     the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have~     personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.~   "
119859|NCT01487044|"~     Establish the efficacy of initial high frequency loading of intravitreal pegaptanib~     bi-weekly during the initial treatment period when the VEGF levels are the greatest and then~     gradually extending the administration frequency to monthly as homeostasis ensues for the~     treatment of DME, as measured by best-corrected visual acuity.~   "
119860|NCT01487031|"~     Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple~     myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve~     progression free survival and overall survival. However, it is a challenging treatment~     process both physically and psychologically. It is a procedure with many side effects that~     can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies,~     such as music therapy, have potential to be an important adjunct in palliation of symptoms~     in patients undergoing chemotherapy.~   "
119861|NCT01487018|"~     Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex~     can be considered a formidable challenge, even to the skilled surgeon. However, the~     development of Computer-Assisted Navigation technology Offers new opportunities in the~     treatment of such deformities. With the help of navigation system,pre- and~     intraoperatively,the objective of any supporting medical device for reconstruction of the~     orbitozygomaticomaxillary complex would be visualization of the real and desired positions~     of the zygoma. In this randomized controlled trial, the investigators would like to evaluate~     the feasibility and accuracy of a new method for planning and realizing zygomatic~     osteotomies in cases of established post-traumatic deformities using computer assisted~     navigation.~   "
119862|NCT01487005|"~     The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure~     of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes~     acute cardiovascular responses as assessed by changes in blood pressure, cardiac function,~     and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.~   "
119863|NCT01486992|"~     There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some~     showed that irinotecan may be effective. The investigators previous study has shown the~     efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II~     study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus~     Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of~     PTX/DDP.~   "
119864|NCT01486979|"~     This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of~     systemic absorption of estradiol during treatment with two different doses of estradiol in~     postmenopausal women with atrophic vaginitis.~   "
119865|NCT01486966|"~     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of~     insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a~     basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.~      The trial adopts a group sequential design, where the analysis of the primary efficacy~     endpoint will be performed at the interim analysis, in addition to the final formal~     analysis. The decision to continue or stop the trial will be based on the result of the~     interim analysis.~   "
119866|NCT01486953|"~     The aim of the current study was to compare the effects of sevoflurane and desflurane on~     respiratory mechanics in patients undergoing repair of pectus excavatum.~   "
119867|NCT01486940|"~     This trial is conducted in Europe and South America. The aim of this trial is to compare the~     glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human~     soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.~   "
119868|NCT01486927|"~     This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study~     comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period~     (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety,~     efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects~     enrolled in Parts 2 and 3.~   "
119869|NCT01486914|"~     This trial is conducted in Europe. The aim of this trial is to compare insulin aspart~     produced by current process and the NN2000 process.~   "
119870|NCT01486901|"~     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence~     between two formulations of Insulatard® in healthy subjects.~   "
119871|NCT01486888|"~     This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence~     between two formulations of Mixtard® 30 in healthy subjects.~   "
119877|NCT01486810|"~     The proposed protocol is an open-label pilot study of the treatment of cocaine dependence~     using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll~     12 patients in an eight-week open-label trial to obtain preliminary data regarding the~     safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine~     dependence and to determine an effective dosage range.~   "
119878|NCT01486797|"~     The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination~     with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously~     treated patients with chronic lymphocytic leukemia (CLL).~   "
119879|NCT01486784|"~     This is a phase I/II, open-label non-randomized study using an investigational new drug,~     TL32711, in patients with AML, MDS and ALL. This study will target subjects 60 years of age~     and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or~     who are newly diagnosed )and subjects 18-59 (relapsed or refractory after failing 3 prior~     lines of therapy). This study will also target subjects 18 years of age and older with MDS~     and ALL.~   "
119880|NCT01486771|"~     Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic~     Retinopathy (PDR) and reduce the need for retinal photocoagulation.~   "
119881|NCT01486758|"~     This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical~     effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial~     Virus (RSV) bronchiolitis.~      HYPOTHESES~      In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo)~     will result in:~        1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum~          and nasal wash measured on day 8 after randomization.~        2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks~          3-52 following randomization.~   "
119882|NCT01486745|"~     This is a prospective, multi-centered study to assess whether urine metabolomics can play a~     role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000~     patients going through an established CRC screening program, and from a further 500 patients~     who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy,~     the 1H NMR spectrum of urine samples will be analyzed for specific metabolites, and~     establish the metabolomic signature of colorectal cancer. The results from metabolomic~     urinalysis of this screening cohort will be compared with results from colonoscopy,~     histological descriptions, fecal occult blood testing (FOBT), and fecal immune testing (FIT)~     to assess the accuracy of urine metabolomics in identifying patients with polyps and~     malignancies. The urine metabolomic results from the colorectal cancer group will be~     correlated with operative, histological and clinical staging to define the role of urine~     metabolomics in assessing colorectal cancer type, location and stage. Additionally~     approximately 300 urine samples from breast cancer patients and 300 from prostate cancer~     patients will be collected to validate that the colorectal cancer signature is unique.~   "
119883|NCT01486732|"~     This is randomized placebo-controlled trial to recognize new cell regeneration in the brain~     using FLT-PET.~   "
119884|NCT01486719|"~     Sensory reconstruction of the finger pulp is a challenging problem. This article reports~     repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches~     of the proper digital nerves (PDNs) were used for maximal sensory restoration.~   "
119885|NCT01486706|"~     Overactive bladder (OAB) syndrome as defined by International Continence Society is a~     pathological condition characterized by irritative symptoms: urinary urgency, with or~     without incontinence, urinary frequency and nocturia. The syndrome often seriously~     compromises the quality of life of the patients. The etiology of the OAB is considered~     multifactorial. Neural plasticity of bladder afferent pathways is one of the proposed~     mechanisms of OAB. The detrusor muscle itself has for many years been the target for drug~     treatment such as antimuscarinics. However, depression of detrusor contractility, may~     results in a reduced ability to empty the bladder and lead to some sympathetic adverse~     effects, which limits the treatment of OAB. Currently the focus of OAB treatment has changed~     to other bladder structures/mechanisms, such as afferent nerves and urothelial signaling as~     targets for intervention. C-fiber bladder afferents nerves may be critical for symptom~     generation in pathologic states such as OAB because these fibers demonstrate remarkable~     plasticity. Up-regulation of bladder C-fiber afferent nerve function may also play a role in~     urge incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of~     Gabapentin's action for neuropathic pain has not been fully elucidated but is appears to~     have inhibitory activity on afferent C-fibers nerve activity; moreover, several studies had~     established the safety of Gabapentin in its treatment of different conditions. Due to the~     proposed mechanism, the investigators suggest that Gabapentin may be a new alternative for~     treating OAB.~   "
119886|NCT01486693|"~     The purpose of this study was to evaluate long term efficacy and safety of topical~     ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.~   "
119887|NCT01486680|"~     Type 2 diabetes (T2DM) and obesity are becoming increasingly common in New Zealand (NZ) and~     worldwide. Both are associated with a risk of early mortality (death). Whilst weight loss~     surgery is known to be effective for weight loss, current research suggests that it may also~     be effective in resolving T2DM in around 60-80% of patients, with some no longer requiring~     their medication. The mechanism for this remains unclear.~      Two main types of weight loss surgery are performed in NZ public hospitals, which include~     gastric bypass and sleeve gastrectomy. The gastric bypass is a more complex procedure~     compared to the sleeve gastrectomy. Whilst both appear to be effective for weight loss (with~     most patients losing more than 60% of their excess weight), it is still not known which one~     is better for treating T2DM.~      This study will therefore compare which of these two surgical procedures is most effective~     at treating T2DM in obese patients, as well as comparing whether there are any differences~     in the amount of weight lost, side effects and quality of life.~   "
119917|NCT01486290|"~     The purpose of this study is to find ways to identify barriers that affect self care in~     older adult with diabetes and to provide cost effective coping strategies to improve~     clinical, functional and psychosocial measures.~   "
119918|NCT01486277|"~     The purpose of this study is to determine the overall cutaneous response rate (participants~     who achieve a complete response or partial response) based on the modified severity weighted~     assessment tool criteria.~   "
119888|NCT01486667|"~     Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical~     practice, and share a number of symptoms and clinical features. It has been shown that~     hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and~     adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the~     time-course and effect of treating subclinical hypothyroidism in OSA patients on the~     respiratory events during sleep is not known.~      Subclinical hypothyroidism is associated with an increased risk of coronary heart disease~     (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of~     thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum~     high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of~     levothyroxine is controversial.~      This project will help us to know if the treatment of subclinical hypothyroidism will~     improve the symptoms and reduce the progression of OSA, which may improve patients' quality~     of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular~     diseases, etc.) or may even reduce mortality.It will help us to know the effect of~     subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.~   "
119889|NCT01486654|"~     The purpose of this study is to evaluate the effectiveness of small amounts of electrical~     current, applied without surgery to the brain, in combination with speech-language~     treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty~     with the comprehension and expression of spoken and written language) following a stroke.~   "
119890|NCT01486641|"~     The purpose of this study is to determine whether the anterolateral in comparison to~     posterolateral approach to the hip arthroplasty gives an equal or better clinical results.~   "
119891|NCT01486628|"~     It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose~     escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in~     healthy volunteers.~      Objectives are to determine:~        1. the maximal tolerated dose of SC ND-0612~        2. the steady state plasma concentration of LD and CD following SC ND-0612 administration.~      Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential~     manner.~   "
119892|NCT01486615|"~     Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and~     thus paradoxically increases episodes of arousal during sleep and thus causes restlessness~     and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote~     the perception of sound sleep in the perioperative period.~      Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will~     be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination~     of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P),~     approximately 90 minutes before surgery.~   "
119893|NCT01486602|"~     This phase I trial studies the side effects and the best dose of hypofractionated radiation~     therapy when given together with chemotherapy in treating patients with stage III non-small~     cell lung cancer that cannot be removed by surgery. Hypofractionated radiation therapy~     delivers higher doses of radiation therapy over a shorter period of time and may kill more~     tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.~   "
119894|NCT01486589|"~     The aim of the study is to test the hypothesis that impaired cardiac autonomic function~     predicts adverse outcome in unselected patients presenting in the emergency ward.~   "
119895|NCT01486576|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
119896|NCT01486563|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
119897|NCT01486550|"~     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential~     nephrotoxic and examine the effects on the circulation and kidneys during administration of~     HES during surgery.~   "
119898|NCT01486537|"~     The aim of this study is to evaluate the level of acidity of blood samples that are been~     taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures.~     Our hypothesis is that samples from teeth undergoing pulpectomy would be acidic while~     samples from teeth undergoing pulpotomy would bo neutral.~   "
119899|NCT01486524|"~     The overall purpose of the study is to determine whether either of the Improved Response~     Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in~     patients with severe sepsis and high risk of death. This will be an international,~     multicenter, prospective-retrospective, nonrandomized, controlled, outcome-blinded,~     genotype-blinded, matched-patients study. No prospective enrollment or treatment of patients~     will occur under this protocol. Retrospectively collected clinical data and DNA samples will~     be analyzed for existing cohorts of patients with severe sepsis who were previously treated~     with DrotAA (treatment group) or not (control group) as part of their standard care in an~     ICU.~   "
119900|NCT01486511|"~     Major surgery is associated with a postoperative hypercoagulable state related to the~     surgical trauma that may lead to thromboembolic complications. To the investigators~     knowledge, only two series have reported the risk of PE after liver surgery with an~     incidence of up to 6.3% The purpose of this study is to identify the independent risk~     factors associated with the development of PE after elective liver surgery.~   "
119901|NCT01486498|"~     Grass pollen and house dust mites (HDM) are the most common allergens causing allergic~     rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy~     (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect~     of SCIT on disease severity classifications in terms of number of days affected- and sick~     days on patients with grass pollen and/or HDM induced disease. These outcome measures will~     be gathered in one single measure: Quality Adjusted Life Years (QALY)~   "
119902|NCT01486485|"~     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is~     known to be an independent risk factor for mortality. Renal replacement therapy (RRT) is the~     mainstay of supportive treatment of patients with severe acute kidney injury. The goal of~     RRT is to achieve adequate correction of uremia, electrolyte abnormalities, and volume~     overload while ensuring good hemodynamic tolerance. The advantages of continuous renal~     replacement therapy (CRRT) are increased time-averaged dialysis dose, less hemodynamic~     instability, and possibly, removal of high molecular weight solutes, such as inflammatory~     cytokines. Solute removal can occur by several different mechanisms in CRRT. For relatively~     small solutes, the importance of diffusion and convection is emphasized, for solutes of~     larger molecular weight, the importance of convection and adsorption is emphasized. The~     ability of a specific CRRT to remove a certain solute is determined by membrane~     characteristics. But actual measurements of middle molecule clearance in large clinical~     trials have not been available in most trials.~      During CRRT, blood is conducted through an extracorporeal circuit, circuit clotting is a~     major problem in daily practice of CRRT, increasing blood loss, workload, and costs. Early~     clotting is related to bioincompatibility, critical illness, vascular access, CRRT circuit,~     and modality. Therefore, one major intervention to influence circuit survival is~     anticoagulation. However, systemic anticoagulation, usually with heparin, can produce~     hemorrhagic complications in patients at high risk of bleeding. To minimize the risk of~     bleeding, a number of alternative regimens has been proposed, however, each of those methods~     has its own limitations and complication. Nafamostat mesilate, a serine proteinase~     inhibitor, while inhibiting various clotting factors in filter circuit, is characterized by~     short half life resulting in little systemic anticoagulation effect. A recently developed~     CRRT AN69ST membrane® (Gambro Inc) is coated with a polyethylene imine (PEI, cationic~     biopolymer) on the membrane surface. Once adsorbed onto the membrane, heparin keeps its~     anticoagulant properties. Therefore CRRT has been managed without systemic administration of~     heparin.~      The investigators will conduct a multicenter prospective randomized controlled open-label~     trial which compares the difference in circuit survival between between nafamostat infusion~     and heparinized saline priming as anticoagulation for CRRT. The primary end-point of this~     study is circuit survival, the time of 1st membrane exchange. The secondary end-point is~     clearance of small molecule (urea) and middle molecule (β2 microglobulin) at 0, 1, 6, 24h,~     ACT(activated coagulation time) measurements after 1hr of the CRRT, Hemorrhagic~     complication. This is a noninferiority trial. The aim is to demonstrate that nafamostat~     infusion is not inferior to the heparinized saline priming. For this purpose, at least 80~     subjects (a total of 160) would be required for each group if type I error rate is 5% and~     type II error is 20% given 20% of drop-out rate during the study period. Block randomization~     will be used by means of a dedicated website.~      There are still conflicting data on the effective exchange time of circuit membrane. Our~     study may help to improve prognosis in patients with severe AKI.~   "
119953|NCT01485822|"~     The purpose of this study was to assess the pigmentation in the trabecular meshwork of~     patients who had been treated for at least 2 years with TRAVATAN compared with patients~     without exposure (or less than 1 month) to a prostaglandin analogue (PGA).~   "
119903|NCT01486472|"~     S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and~     Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy~     for GC patients who received D2 surgery in Eastern Asian patients.~      Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been~     reported from some case and small-sized studies. The incidence of developing LDO has been~     estimated to about 15~20% of patients receiving S-1 therapy in some retrospective studies.~     However, there is no prospective report on the incidence of LDO in patients receiving S-1~     chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been~     systemically studied until now. Suggested mechanism of LDO involves direct secretion of S-1~     into the tear.~      Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC~     patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the~     development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will~     be explored. These results will help clinicians identify patients who are at high risk of~     developing S-1-associated LDO.~   "
119904|NCT01486459|"~     Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with~     extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy~     to the primary tumour. It is now part of care to also offer Prophylactic Cranial Irradiation~     (PCI) in order to prevent spread of the cancer into the brain.~      Cognitive impairment can result after cranial irradiation. Lithium is thought to be~     neuroprotective. It is hypothesized that lithium administration with PCI will be safe,~     tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive~     impairment.~   "
119905|NCT01486446|"~     This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel~     group study with XPF-002 applied twice daily over 14 or 21 days in patients with~     Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether~     XPF-002 is safe and effective in the treatment of pain caused by IEM.~   "
119906|NCT01486433|"~     The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty~     acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.~   "
119907|NCT01486420|"~     The purpose of the study is to investigate which strategy is superior in trigger finger~     Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid~     injections.~   "
119908|NCT01486407|"~     This study will evaluate using intraosseous vascular access and intravenous vascular access~     to give patients the necessary medications to perform rapid sequence intubation, for~     patients with airway difficulties. The investigators think the device operator will find the~     intraosseous and intravenous routes equal for drug delivery.~   "
119909|NCT01486394|"~     The purpose of this study is to determine whether focused sonography of the heart, lungs and~     deep veins can increase the number of patients with respiratory symptoms correctly diagnosed~     in an emergency department.~   "
119910|NCT01486381|"~     This trial is conducted in South Africa. The aim of this trial is to investigate Long term~     safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in~     trial BIAsp-1240.~   "
119911|NCT01486368|"~     This is a non-randomized open label multicentre Phase II trial to evaluate the response rate~     of PF03446962 in patients with advanced malignant pleural mesothelioma who have been~     previously treated with cytotoxic chemotherapy.~   "
119912|NCT01486355|"~     Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an~     early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child~     mortality compared with the WHO strategy of one dose of MV at 9 months.~      Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the~     standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of~     age1. As in a previous trial it is expected that the beneficial effect is strongest for~     girls.~      Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles~     antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than~     children receiving MV at 4 months with no detectable MatAb.~      Implications: These hypotheses are based on a previous RCT showing strong beneficial effects~     of providing an early measles vaccine, in particular among children with MatAb.~   "
119913|NCT01486342|"~     Despite decades of research, the mortality in acute lung injury remains very high and~     treatment options are very limited. Given these facts, the best treatment modality may be in~     prevention of this lethal syndrome.~      Historically, imaging has played a crucial role in understanding ALI. The appearance of~     chest radiography is one of the consensus criteria in defining ALI, and commuted tomography~     (CT) scans further advanced the understanding of the pathoanatomy of ALI. While valuable,~     these imaging modalities are nonspecific and do not incorporate functional cellular~     physiology.~      PET imaging measures concentrations of radioisotopes in the body. By embedding in, but not~     altering molecules, the natural fate of these tracers can be studied with PET imaging.~     Advances in the understanding of ALI include blood flow distribution, as well as the~     response to alveolar recruitment maneuvers and prone positioning. Not all patients who are~     receiving mechanical ventilation develop ALI. Inflammation in the lungs is known to play a~     key early role in the development and progression of ALI. Secondary to inflammation, the~     lungs develop edema and do not exchange oxygen as well. This early inflammation is in part~     driven by a specific type of immune cell called the neutrophil. These cells seem to travel~     and become sequestered in the lung- they are recruited to the lung during this~     inflammatory stage. When there, these neutrophils release inflammatory substances which are~     integral in the development of ALI. Neutrophils use primarily glucose as a fuel source. The~     radio isotope [18F]Fluorodeoxyglucose (FDG)is a glucose analog and therefore taken~     up/ingested by the neutrophils as a part of their normal metabolism. Because of this fact,~     positron emission tomography (PET) using the radio isotope [18F]FDG is a highly sensitive~     marker to look at the recruitment of neutrophils to the lung, therefore quantifying the~     degree of pulmonary inflammation prior to the development of ALI.~      The investigators seek to examine the relationship of pulmonary inflammation in patients at~     risk for ALI, but without clinical evidence of the syndrome. The investigators seek to~     enroll ten patients in a pilot trial.~   "
119914|NCT01486329|"~     First-in-human phase I dose escalation study in patients with locally advanced, inoperable~     and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the~     investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and~     immunogenic response to the investigational vascular endothelial growth factor receptor 2~     (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.~   "
119915|NCT01486316|"~     The purpose of this study is to characterize the feasibility and impact of a diagnostic tool~     that may help clinicians identify when patients are at higher risk of visiting the hospital~     for a heart failure event. The study will use a non-experimental device that is inserted~     just under the skin of the chest, which continuously monitors the heart rhythm in~     combination with an experimental web-based heart failure risk status. Patients with atrial~     fibrillation and heart failure will be evaluated to collect data about the potential of this~     risk status to help improve patient outcome.~   "
119919|NCT01486264|"~     This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment~     intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to~     determine if the response to treatment is comparable in both how it works and any side~     effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the~     treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to~     shorter treatment intervals. An investigational use is one that is not approved by the FDA.~   "
119920|NCT01486251|"~     The purpose of this study is to evaluate and quantify the dynamic modifications of tumor~     blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of~     Axitinib.~   "
119921|NCT01486238|"~     Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic~     Macular Edema (DME), as compared to injections every 6 weeks.~   "
119922|NCT01486225|"~     The purpose of this study is to identify the nature of skin lesions that develop on contact~     with the grip-top bands of medical compression stockings, which are composed mainly of~     silicone.~   "
119923|NCT01486212|"~     Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms~     metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their~     structure can react with other molecules resulting in cell damage. This damage is due to~     several mechanisms.~      This is e.g what happens when human tissue is cut of from blood supply for a time, and the~     blood supply is again restored. The damage following the restoration of blood is known as~     ischemia-reperfusion injury. The reopening of the vessels and thereby supplying oxygenated~     blood to the deprived tissue can in it self contribute to cell death due to excessive~     amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize~     their damage.~      The purpose of the investigators methodology study is to make an ischemia-reperfusion model~     on healthy volunteers (on the lower limb) to examine the expression of markers that are~     expressed in the muscle and the blood when blood supply is cut of to an area and later~     restored. The investigators wish to measure the product of the damage caused by free~     radicals and the levels of antioxidants.~      If the investigators can produce elevation of oxidative and inflammatory markers, this model~     can be used to test antioxidative intervention.~   "
119924|NCT01486199|"~     The investigators are developing a new nuclear medicine imaging technique for measuring~     liquid absorption in the airways that can be applied to screen new medications being~     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of~     the small molecule radiopharmaceutical Indium 111-DTPA will indicate changes in liquid~     absorption in the airways and demonstrate whether new CF medications will be effective. In~     this study the investigators will further develop this technique through testing involving~     pediatric CF patients and healthy control subjects.~   "
119925|NCT01486186|"~     The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine~     for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).~   "
119926|NCT01486173|"~     The main goal of this study is to determine the association between:~        -  the quantity of mother's milk and duration of breastfeeding~        -  the intake of polyunsaturated fatty acids and iron during hospitalization and the~          development of preterm infants born with a GA < 32 weeks.~   "
119927|NCT01486160|"~     This study will be conducted in a 208-bed nursing home in Maribor. The investigators will~     observe a group of a 100 nursing-home residents and 50 health care workers- employees in the~     nursing home- in a six months period.Influenza vaccination status will be recorded in all~     participants at the beginning.~      At the beginning and at the end of the study the blood samples for vitamin D concentration~     determination and nasopharyngeal swabs for molecular detection of respiratory viruses will~     taken in all of the participants.~      The study will observe number of viral respiratory tract infection in participants and~     identify the viral etiology of infections during 6 months observational~     period.Nasopharyngeal swab and blood sample will be taken in each of the participant who~     will suffer an acute respiratory tract infection (upper or lower respiratory tract~     infection) and viral agents of respiratory tract diseases will be searched for. The~     investigators will try to detect different viral agents of respiratory tract infection:~     human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial~     virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with~     newer molecular methods (real-time polymerase chain reaction, real-time reverse~     transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the~     participants.~      During the study period the investigators will monitor the daily number of visitors (adults,~     preschool children and pupils) in each nursing home room. The epidemiological aspect of~     respiratory viral infection will be assessed.~      Our study hypothesis is that lower respiratory tract infections in elderly can be caused by~     viruses other than influenza.~      The investigators would like to know if hypovitaminosis D is a risk factor for respiratory~     tract infections in nursing home residents and employees.~      The investigators would also like to know if the number of respiratory tract infections in~     elderly correlates with the number of visitors in nursing home, small children in~     particular.~   "
119928|NCT01486147|"~     The objective of the study is to validate a visual method of presenting nutritional~     information by determining if users of the visual method remember food properties better~     than users given the same information in a non-visual form with texts and tables.~   "
119929|NCT01486134|"~     Object of the study:~      To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular~     carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of~     reduction of the number of procedure required to obtain complete ablation of the tumors.~      Experimental plan :~      This pilot study consist to perform in a single center a single procedure of the multipolar~     RF ablation under MR temperature monitoring for the treatment of up to three HCC with~     diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion~     of the study will be the rate of complete ablation one month after one RFA procedure~     performed under MR temperature monitoring. The secondary criteria are, the 2-years local~     recurrence rate (after the first initial RF ablation procedure performed under MR~     temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case~     of remnant viable foci of tumor), the potential reduction of the number of RF procedures~     required to achieve complete necrosis and the complication rate of RF ablation procedure~     performed under MR temperature monitoring.~      In exploratory attempt, the study will include comparative assessment of these criteria with~     a historic leg of patients previously treated by the same operator in the same center for~     similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.~   "
119969|NCT01485614|"~     The purpose of the study is to assess the safety of the addition of sitagliptin, and its~     effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2~     diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this~     study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.~   "
119970|NCT01485601|"~     The purpose of this study is to find an optimal dose to determine the safety and~     tolerability of a single dose of MT10109(clostridium botulinum type A) administered by~     intramuscular injection in subjects with glabellar lines compared with the standard dose of~     BOTOX®~   "
119930|NCT01486121|"~     Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized~     in Intensive Care Unit (ICU). That is called  sedation  and aimed to reduce both pain and~     anxiety and also to allow an effective and atraumatic mechanical ventilation. However,~     sedation excess and ventilator support excess, both in duration and intensity, are~     associated with an excess morbidity. Patients usually are systematically sedated after~     having been intubated. Then, sedation is stopped first before ventilator support is weaning.~     Several studies shown that rationalized protocols of sedation and ventilation orderings had~     a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in~     surgical patients is still unknown. Moreover, no study has evaluated an optimized paired~     strategy of sedation-ventilation based on the priority setting of ventilation. This priority~     setting of ventilation should increase patient's comfort in spite of increasing sedatives~     and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration~     and intensity of these treatments could improve surgical patients' outcome in ICU.~   "
119931|NCT01486108|"~     Recently a novel stimulation design was developed, called burst stimulation. In a~     non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation~     over a period extending more than 2 years, and even though an incidental finding, this~     design seemed capable of suppressing pain without mandatory induction of paresthesias. This~     permits for the first time to scientifically prove that spinal cord stimulation is better~     than placebo stimulation. A study was therefore initiated to find out whether spinal cord~     stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled~     way.~   "
119932|NCT01486095|"~     Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double~     stent technique is used) is associated with a higher risk for stent thrombosis. Different~     factors may play a role in the higher risk for stent thrombosis in bifurcation lesions.~     Possible mechanisms are delayed endothelialisation due to the action of the drug, coating~     polymers, or overlapping stent segments, incomplete stent apposition at specific sites in~     the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation~     site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts)~     appears to be the most powerful predictor of stent thrombosis.~      This prospective study will assess the differences in stent strut coverage and stent strut~     apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus~     A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus~     A9-eluting stents in the distal main vessel and the side branch versus treatment with the~     culotte technique using the Xience Prime everolimus-eluting stents.~   "
119933|NCT01486082|"~     Due to the high rate of resistance to clarithromycin in our area the investigators proposed~     an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in~     order to improve the rate of eradication.~   "
119934|NCT01486069|"~     The present study intends to clarify whether there is positional mandibular stability in~     patients to be submitted to orthognathic surgery. In case of any instability exists, it is~     needed to understand if this could be related to a particular type of dentofacial deformity~     or could have any short-term or long-term influence on outcomes of the orthognathic surgery.~   "
119935|NCT01486056|"~     This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG~     data.~   "
119936|NCT01486043|"~     The purpose of this study is to determine whether metformin is an effective adjunctive~     treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL)~     undergoing induction chemotherapy~   "
119937|NCT01486030|"~     Acute exercise such as in exercise stress test would affect the peripheral gene expression~     levels of the 23 genes in the CORUS CAD algorithm and the time frame.~   "
119938|NCT01486017|"~     The purpose of this study is to determine the relative bioavailability and pharmacokinetic~     profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the~     safety and tolerability after a single dose of three different strengths of a new tablet~     formulation.~   "
119939|NCT01486004|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol~     and norethindrone (administered once a day) and on the levels of progesterone, luteinizing~     hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol~     and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.~     Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen~     will be studied. Steady-state is a term that means that the drug has been given long enough~     so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is~     being investigated for the treatment of chronic hepatitis C virus (HCV) infection.~     Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in~     the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.~   "
119940|NCT01485991|"~     The purpose of this study is to demonstrate the efficacy of TMC435 in combination with~     peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority~     compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously~     failed PegIFN.~   "
119954|NCT01485809|"~     Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor~     (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC).~     Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was~     efficacious and less toxic, compared with previous results, than was chemotherapy in~     patients with previously-treated non-small-cell lung cancer. Two phase III trials of~     gefitinib in advanced non-small-cell lung cancer followed on from the IDEAL phase II~     studies: Iressa Survival Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating~     REsponse and Survival versus Taxotere (INTEREST). Although the phase III ISEL trial failed~     to prove the superiority of gefitinib treatment compared to placebo in previously treated~     patients, a subgroup analysis demonstrated improved survival in particular populations~     (Asians and non-smokers). The INTEREST study compared an EGFR tyrosine kinase inhibitor with~     chemotherapy in pretreated advanced non-small-cell lung cancer. In INTEREST, survival was~     similar for gefitinib and docetaxel in almost all subgroups; no EGFR-related biomarker or~     any clinical factor (including female sex, adenocarcinoma histology, never-smoker, and Asian~     ethnicity) appeared to be predictive of a greater survival benefit for gefitinib versus~     docetaxel. However, these factors may still be predictive of a greater survival benefit for~     gefitinib and/or docetaxel versus best supportive care; alternatively, they may just be good~     prognostic factors. Progression free survival and overall response rate was no statistically~     significant difference between gefitinib and docetaxel. This suggests gefitinib can provide~     similar overall survival to docetaxel in pretreated advanced non-small-cell lung cancer~     patients. These studies have demonstrated that gefitinib is effective for the second-line~     treatment of NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as~     second-line chemotherapy.~      But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology.~     This trial will investigate the efficacy and safety of gefitinib in locally advanced,~     metastatic NSCLC patients with squamous cell histology who have failed first-line~     chemotherapy.~   "
119941|NCT01485978|"~     This is a phase III, multi-centre, randomised, placebo-controlled, patient and~     investigator-blind study in paediatric patients with early stages of Alport syndrome to~     assess the safety and efficacy of the ACEi ramipril in slowing disease progression.~      Alport syndrome stages that describe the extent of renal damage and loss of function are~     defined as:~        -  0 Microhaematuria without microalbuminuria (usually at birth)~        -  I Microalbuminuria (30-300 mg albumin/gCrea)~        -  II Proteinuria >300 mg albumin/gCrea~        -  III > 25% decline of normal renal function (creatinine clearance)~        -  IV End stage renal failure (ESRF)~      Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to~     receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated~     open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation~     after eligibility is confirmed, and patients who have been treated with ramipril prior to~     the study, may be treated open-label with ramipril as per protocol. The total number of~     patients will not exceed 120, with the number of randomised patients not exceeding 60, and~     the number of patients treated open label from Day 1 of the study aimed to be approximately~     60.~      Randomised patients whose disease progresses to the next disease level during the 3 year~     treatment period will be unblinded, and open label ramipril treatment will be initiated and~     continued, respectively, depending on prior treatment randomisation.~   "
119942|NCT01485965|"~     The primary purpose of this study is to assess the effect of food upon the pharmacokinetics~     (PK) of SEN0014196 in subjects with Huntington disease (HD).~   "
119943|NCT01485952|"~     The primary objective of this study is to provide biological samples from patients with~     Huntington's disease to allow characterisation of the pharmacological mechanism of action of~     SEN0014196.~   "
119944|NCT01485939|"~     The investigators hypothesized that application of a 5% lidocaine patch would be associated~     with reduced pain scores after operation compared with placebo patch in patients undergoing~     laparoscopic cholecystectomy.~   "
119945|NCT01485926|"~     The primary objective:~      -To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast~     cancer, using pathological complete response (pCR) as the primary endpoint (Phase II).~      Secondary objectives:~        -  To assess the clinical response rate and overall response rate for docetaxel and~          carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2~          positive breast cancer.~        -  To assess the relationship between drug exposure and adverse events.~        -  To examine potential molecular and pharmacological markers of response to trastuzumab~          and lapatinib~        -  To assess Disease-free Survival (DFS) and Overall Survival (OS)~        -  To determine if prophylactic Loperamide significantly reduces the number of diarrhoea~          -related adverse events.~   "
119946|NCT01485913|"~     The project will test the implementation of a specific methodology for education of type 2~     diabetic patients that will be set up using patients involved (peer educators) and 3 guides~     developed specifically for the therapeutic education of type 2 diabetic patients. This~     project will take place in 1 sites in mali : the capital Bamako. 75 diabetic patients will~     be subjected to intervention with this methodology and 75 other diabetic patients will be~     the control group. At various stages of the project, the investigators will analyze the~     impact on biological, anthropological constants, etc ... of the group undergoing the~     intervention compared to the control group.~   "
119947|NCT01485900|"~     Primary Objective:~        -  To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in~          patients with moderate chronic kidney disease (CKD) on stable angiotensin converting~          enzyme-inhibitor (ACE-I)~      Secondary Objectives:~        -  To assess in patients with moderate CKD the effect of concomitant multiple dose of~          SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate~        -  The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to~          ACE-Is (AcSDKP)~        -  The pharmacokinetic profile of repeated oral administration of SAR407899A during~          co-administration of ACE-Is~   "
119948|NCT01485887|"~     This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete~     the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate~     in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase.~     The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication~     dosing.~   "
119949|NCT01485874|"~     The purpose of this trial is to determine whether BIBF 1120 can be safely combined with~     pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the~     combination in patients with platinum-resistant ovarian cancer (phase II).~   "
119950|NCT01485861|"~     This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib,~     open-label stage in which the recommended Phase II dose will be determined for GDC-0068 and~     GDC-0980 in combination with abiraterone and prednisone/prednisolone and a Phase II, 3-arm,~     double-blind, randomized comparison of GDC-0068 with abiraterone and prednisone/prednisolone~     versus placebo with abiraterone and prednisone/prednisolone.~   "
119951|NCT01485848|"~     Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial~     benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare~     the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in~     patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any~     significant changes in the safety profile of weekly paclitaxel alone compared to the doublet~     combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this~     new drug combination.~   "
119952|NCT01485835|"~     The purpose of this study is to find out what effects, good and/or bad, that ganetespib and~     bortezomib has on you and your cancer. The investigators will determine the side effects of~     different dose levels of ganetespib when given alone and the effect it has on your cancer~     alone. The investigators will also determine the side effects of ganetespib at different~     dose levels when given in combination with bortezomib and the effect the combination has on~     your cancer. The study will measure levels of the drug in your blood and bone marrow as~     well.~      Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration~     (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is~     Velcade®.~      Ganetespib is considered investigational because it has not received approval from the~     Food and Drug Administration for general use, although it has been previously tested in~     humans.~   "
119956|NCT01485783|"~     Approximately 200 children age 6 - <18 years receiving medications for essential~     hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a~     routine clinic visit. Participating subjects will be asked to wear the ambulatory blood~     pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements~     obtained with the ABPM will be compared to measurements obtained by routine clinical~     procedures documented in the subject's clinical chart. Kappa statistic will be utilized to~     compare differences in documented BP control between the two measures as well as changes in~     therapeutic management decisions by treating physicians with the addition of the ABPM~     readings. The overall goal is to confirm that ABPM leads to an increased detection of~     uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive~     medication regimens.~   "
119957|NCT01485770|"~     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in~     the treatment of excessive daytime sleepiness in adults with narcolepsy.~   "
119958|NCT01485757|"~     HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and~     exercise tolerance will be abnormal in the population of young heart transplant patients at~     baseline, and that each will show a trend towards improvement following a 12 week course of~     oral L-arginine, with regression towards the baseline following the 12 week washout period.~   "
119959|NCT01485744|"~     LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade~     of molecular events that control cell growth and have been linked with the development of~     many human cancers, including pancreatic cancer. Information from research studies suggests~     that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In~     this research study, the investigators are looking to determine the maximum dose of LDE225~     in combination that can be given safely to patients with locally advanced or metastatic~     pancreatic cancer.~   "
119960|NCT01485731|"~     Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for~     locally advanced cervical cancer.~   "
119961|NCT01485718|"~     Glucomannan is a dietary supplement that has been marketed for weight loss. There is some~     research that supports this claim but more research is necessary. This is research study is~     being conducted to determine if the dietary supplement glucomannan is effective for weight~     loss in adults greater than 18 years of age who are overweight.~      Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either~     glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times~     daily. The study will last for 12 weeks.~      At the start of the study participants will be asked questions about current medications and~     diet/exercise regimen, a weight and height will be obtained, and they will be given a~     one-month's supply of study supplement. An investigator will call each participant after~     they have been taking the supplement for 2 weeks to ensure that the participant is~     tolerating the supplement and answer any questions. Throughout the study, participants will~     be required to follow-up with investigators in the office every 4 weeks (a total of 3~     follow-up appointments). Every 4 weeks, the investigators will weigh participants, count the~     leftover capsules from the previous month, and ask about any adverse effects you may be~     experiencing. At the conclusion of the study, a final weight will be compared with the~     baseline weight to determine if the medication had an effect on weight loss.~   "
119962|NCT01485705|"~     The aim of the study is to determine the frequency of sub-optimal care in the initial care~     (before arrival at the intensive care unit) of children from West France regions suffering~     of severe bacterial infections.The characteristic optimal or not of the initial medical~     care will be determined by 2 independent experts, blinded from each other and blinded from~     the issue of the care. In case of a discordance between the two experts, a third expert will~     be demanded. Three possibilities of conclusion will be proposed to the experts: sure~     sub-optimal medical care, possible suboptimal care and optimal care.~   "
119963|NCT01485692|"~     This study aims to evaluate the efficacy and safety of four options of medications in the~     management of acute psychomotor agitation,or violence and aggression situations in health~     services. All of the treatment options are already approved and currently used for this~     purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine,~     olanzapine and ziprasidone. The investigators hypothesized that all treatment options are~     effective in the treatment of acute agitation, but the combination haloperidol plus~     promethazine could elicit more adverse affects than the others.~   "
119964|NCT01485679|"~     The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in~     identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results~     will be compared to those obtained by the pathological analysis of the removed piece of~     pancreas.~   "
119965|NCT01485666|"~     The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management~     Kit for HeartMate II driveline stabilization and exit site management.~   "
119966|NCT01485653|"~     The use of ultrasonography as an adjunct to regional anesthesia has significantly increased~     in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of~     ultrasound guidance. Real time sonography of nerve structures ensures an optimal~     distribution of the block solution. When compared to other methods of nerve localization,~     sonography decreases: failure rate procedure time and the onset time for blockade.~     Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased~     procedure related complications such as nerve injury and unintentional vascular puncture.~      Traditional axillary block techniques relying on surface anatomical landmarks require large~     volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy~     offered by ultrasound, some studies have shown that low volumes of local anesthetic can~     yield successful axillary plexus blockade. Therefore, the tradition of using large volumes~     of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.~      Although recent investigations support using a low volume of local anesthetic for brachial~     plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary~     objective of this study was to evaluate 2 different volumes of local anesthetic for axillary~     blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5%~     solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks,~     which is secondary to: rapid onset of action, intermediate duration of effect, and relative~     low cost. The primary outcome was block success rate for outpatients undergoing distal upper~     limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time~     required to perform the block, and onset of sensory and motor blockade.~   "
119967|NCT01485640|"~     This is an open-label continuation study designed to monitor the safety, tolerability and~     effectiveness of lurasidone in subjects who have completed participation in a lurasidone~     extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment~     with lurasidone.~   "
119968|NCT01485627|"~     The purpose of this study is to determine whether a combined intervention for patients,~     caregivers and oncologists improves communication, quality of life, and quality of care.~   "
119971|NCT01485588|"~     Phase 1: The purpose of this study is to evaluate the safety and tolerability of single~     ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.~      Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at~     2 different dose levels.~   "
119972|NCT01485575|"~     Intravitreal dyes are intended to make the surgical extraction of the Internal limiting~     membrane (ILM) safer and more complete. However, the search for an adequate vitaly dye is~     ongoing. The most commonly used vital dye is Indocyanine green (ICG), although it is not~     approved for intravitreal use and has been associated with ocular toxicity. The reason for~     its continued popularity seems to be that it stains the ILM better than the approved and~     less toxic alternative substances Brilliant Blue G (BBG) and Trypan blue (TB). According to~     anecdotal reports from surgeons, another reason for ICGs popularity may be the fact that it~     seems to make ILM removal easier. Ultimately, the intention of the investigators research is~     to identify possible modifications to existing dyes to reach improved intraoperative dye~     utility combined with a favorable safety profile.~   "
119973|NCT01485562|"~     A double-blind individual randomized controlled study of misoprostol vs. placebo for~     treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in~     Pakistan.~   "
119974|NCT01485549|"~     The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels~     are increased in MSA patients compared to controls and on other hand whether there is a good~     agreement between cerebrospinal fluid (CSF) and plasma levels.~   "
119975|NCT01485536|"~     The goal of this clinical research study is to learn if AUY922 can help to control~     refractory or recurrent lymphoma. The safety of AUY922 will also be studied.~      AUY922 is designed to block tumor growth by blocking a protein.~   "
119976|NCT01485523|"~     The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements :~     suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an~     IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally~     the presence of mite allergens in the environment where the patient is symptomatic.~     Unfortunately, the link between symptoms and exposure to dust mites is rarely found and~     according to in the literature, 30% of rhinitis sensitized to house dust mites did not react~     during a conventional nasal provocation test (TPNC) to dust mites. Thus, TPNC to dust mite~     has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a~     doubt due to the poly sensitization of the patient, or the lack of specific symptoms and /~     or the variability of the allergic symptoms during the year. However, this test has not been~     completely validated with a study including a significant number of patients. That's why the~     investigators plan a prospective single-center comparative open study with the main~     objective is to determine the sensitivity and specificity of conventional nasal provocation~     test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust~     mites and patients with allergic rhinitis not sensitized to dust mites. The investigators~     secondary objective is to compare the TPNC a faster TPN-called minute (60 minutes) and~     which allow a wider use. If the investigators demonstrate the validity of TPN then it would~     become the gold standard needed to decide on a desensitisation to mites.~   "
119977|NCT01485510|"~     Early intervention for maltreated infants can improve mental and physical health throughout~     life and benefit families and society as a whole. The New Orleans Model provides intensive~     assessment and treatment for families of maltreated preschool children in foster care, with~     recommendations to court about adoption, or permanent return to birth families. The New~     Orleans Model appears to have led to better informed decisions about permanent placement and~     to better child mental health in Louisiana. The investigators propose an exploratory~     randomised controlled trial investigating the effectiveness of the New Orleans Model in the~     Scottish context, informing the development of an economic model to explore the potential~     cost-effectiveness. Families with a maltreated child under 5 years of age will be offered~     the New Orleans Model or case management i.e. quality assured services as usual, using~     random allocation. The investigators will measure outcome using well validated measures of~     parent-child interaction, cognition and attachment.~   "
119978|NCT01485497|"~     The purpose of this study is to determine whether the Optical coherence tomography (OCT) can~     image the structure and geometry of hollow organs of the upper airway in sleep disorder. The~     research can identify the obstruction sites that help the select the appropriate treatment~     for potential surgical candidates.~   "
119979|NCT01485484|"~     The research at University of California Irvine, Beckman laser institute and Praxis~     Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical~     imaging tool that can determine acute sinusitis and the response to treatment therapy.~   "
119980|NCT01485471|"~     Otitis media is more common in young children and it is estimated that 75% of all children~     experience at least one episode before the age of three. Otitis media is one of the common~     pediatric diagnoses and recurrent episodes account for the most commonly performed surgical~     procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition~     which depends on subjective assessment of the ear drum via direct visualization using an~     otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for~     the analysis of ear drum and the middle ear.~   "
119981|NCT01485458|"~     Controversy exists regarding the optimal management of acute traumatic cervical spinal cord~     injury (SCI), especially those without bone injury. Although surgical decompression is often~     performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery~     continues to be a subject of intense debate. In this randomized controlled trial, the~     investigators compare two strategies: early surgery within 24 hours after admission and~     delayed surgery following at least 2 weeks of conservative treatment. The purpose of this~     study is to examine whether early surgery would result in greater improvement in motor~     function as compared with delayed surgery.~   "
119982|NCT01485445|"~     The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF)~     inhalation powder (single strip configuration) compared with FF inhalation powder (two strip~     configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate~     (FF), is being developed both as a monotherapy for the treatment of asthma and in~     combination with vilanterol (VI) for the treatment of asthma and Chronic Obstructive~     Pulmonary Disease (COPD). Thirty healthy male and female subjects will be enrolled in the~     study to ensure twenty-four evaluable subjects.~   "
119983|NCT01485432|"~     This study is designed to compare the incidence of delayed graft function in patients~     following renal transplant surgery with different perioperative hemodynamic managements: a~     goal directed hemodynamic management group (using PiCCO) and a control group.~   "
119984|NCT01485419|"~     Traumatic injury is a major public health problem with an immense societal cost. Despite~     improvements in trauma management, patients continue to suffer significant morbidity and~     mortality. Evidence suggests that males and females tolerate severe injury differently with~     a greater protection afforded to females. Determining the mechanisms responsible for these~     sex-based outcome differences after injury, focusing specifically on the early sex-hormone~     environment post-injury, may allow those at highest risk for poor outcome to be predicted~     and promote interventions that can improve outcomes for all injured patients. The goal of~     this study is to determine if the early sex hormone environment soon after injury has~     effects on the intensity of the immune response, resuscitation and blood transfusion~     requirements, and important clinical outcomes including mortality, organ failure and~     infection, following significant injury.~   "
119985|NCT01485406|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the~     GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study~     entry.~   "
119986|NCT01485393|"~     The purpose of this study is to determine whether dexmedetomidine can be used to induce~     normal physiological sleep in humans.~   "
119987|NCT01485380|"~     The investigators are doing this research study to find out how and where dexmedetomidine, a~     sedative anesthetic, acts in the brain. The investigators will do this by using a machine~     that records the brains electrical activity, called an electroencephalogram (EEG), and brain~     imaging scans to look at the brain.~   "
119988|NCT01485367|"~     This is an open label 6 month pilot study for male and female participants over the age of~     52 that desire treatment and prevention of senile purpura of the forearms.~      This study will be evaluating the effects of Adapalene 0.3% for the use in the treatment and~     prevention of senile purpura.~   "
119989|NCT01485354|"~     The purpose of this study is:~        1. To demonstrate that upper extremity training with the Armeo system with a sensing glove~          will result in greater functional improvement as measured by clinical functional~          outcome measures, than Armeo training with grip sensor, in a chronic post-stroke~          population with impaired upper extremity function.~        2. To compare kinematic data following training with grip sensor vs. sensing glove, using~          data provided by the Armeo system, clinical outcome measures and data derived from the~          analysis of upper extremity movements using a camera-based motion analysis system.~   "
119990|NCT01485341|"~     The idea is to evaluate if the so called Gluten Sensitivity is a real clinical entity.~     Gluten sensitive (GS) persons are defined as those patients, being neither celiac or~     allergic to weat, who develop symptoms following gluten consumption. This will be achieved~     by evaluating a global symptom score in GS patients receiving gluten compared to those~     receiving placebo (primary end point). Symptoms to be evaluated: gastrointestinal~     (Gastrointestinal Symptom Rating Scale, GSRS); not-gastrointestinal (specifically built~     evaluation scale); VQV scale, built to evaluate quality of life. Gluten or placebo will be~     administered daily (10 g) for 15 days; for the 15 days before and 15 after all patients will~     stay on Gluten Free Diet (GFD). Besides clinical evaluation (each week for 6 weeks),~     intestinal permeability testing and blood sampling will be requested for the identification~     of possible markers (serological, gut barrier function, immunological and expression of~     tight junctions constitutive proteins) that may be of help to differentiate the condition of~     gluten sensitivity (GS) from that of Celiac Disease (CD)(secondary end point). Inclusion and~     exclusion criteria for patients enrolling are strictly dependant on the given Gluten~     sensitivity definition. We expect to experience a worsening of gastrointestinal and~     extra-gastrointestinal symptoms, from hours to days, with an increase in the overall symptom~     score, above the cut off, in at least 45% of GS subjects enrolled and that have received~     gluten compared to GS who received placebo.~   "
119991|NCT01485328|"~     This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic~     digestive complaints.~   "
119992|NCT01485315|"~     Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive~     care unit. The evidence that blood transfusion leads to improved outcome is limited and the~     blood may be harmful to some of these patients. To bridge the gap between clinical practice~     and evidence, a large randomised clinical trial is needed to document the efficacy and~     safety of RBC transfusion in these very sick patients~   "
119993|NCT01485302|"~     Primary Objective:~      - To assess the safety and tolerability of escalating single and multiple doses of SAR228810~     in patients with Alzheimer's disease (AD)~      Secondary Objective:~      - To evaluate the pharmacokinetic properties of SAR228810 after escalating single and~     multiple doses of SAR228810 in AD patients~   "
119994|NCT01485289|"~     The intent of this study is to complete the collection of clinical data on subjects enrolled~     in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the~     now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the~     clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased~     their funding of the trial, a number of enrolled patients had not yet completed the two year~     follow-up visit defined as the study endpoint in the clinical investigation plan. No~     additional patient treatment is required to complete the study. Rachiotek has interest in~     pursuing IDE approval for a new study and the information collected in this study is~     essential for supporting the new Investigational Device Exemption application.~   "
120001|NCT01485198|"~     Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria~     will be allocated into two groups:~        -  The control group will receive Acetaminophen 750mg orally every 8 hours~        -  The experimental group will receive Autologous Hematopoietic Stem Cells from bone~          marrow (BMASC)~      Signed informed consent is required, as well as answering a questionnaire.~      Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3~     consecutive days and, on the 4th day a bone marrow harvest under general sedation will be~     performed from posterior iliac crests. The patient will remain in the recovery room while~     the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused~     to the joint under local anesthesia.~      The procedure is ambulatory.~   "
119995|NCT01485276|"~     Background:~      - Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for~     Parkinson s disease. It stimulates a part of the brain that helps control symptoms like~     tremor, stiffness, and slow movements. However, many people continue to have unsteadiness~     and slowness while walking, trouble swallowing, and speech problems even with STN DBS.~     Another type of DBS focuses on a part of the brain called the pedunculopontine nucleus~     (PPN). PPN DBS has improved walking in some people with Parkinson's disease. Researchers~     want to see if combining the two types of DBS may help control symptoms better than STN DBS~     alone.~      Objectives:~        -  To see if PPN DBS can help walking, balance, speaking, and swallowing in those who~          already have STN DBS.~        -  To study how the DBS combination affects brain function.~      Eligibility:~      - Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but~     still have difficulty walking, swallowing, and speaking.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have neurological tests and other tests to measure Parkinson s disease symptoms.~        -  This study requires eight visits over 1 year. One of the visits will be a 9- to 10-day~          admission to the NIH Clinical Center for DBS surgery.~        -  Participants will have PPN DBS surgery. The surgery will be done in two steps. In the~          first step, the leads will be placed in the brain. In the second step, 1 week later,~          the stimulator device will be placed in the chest or abdomen.~        -  One month after the surgery, participants will have a study visit to program the PPN~          DBS device to find settings that will improve walking and balance.~        -  Participants will have study visits 2, 3, 6, and 12 months after surgery. Each visit~          will be used to check the stimulators and make any adjustments needed to try to improve~          walking and balance or to lessen side effects. Participants will have tests of walking~          and balance, speech, and swallowing. Some tests will be done with different~          combinations of the stimulators on or off to see the effects of each set of~          stimulators.~   "
119996|NCT01485263|"~     Objective~      The objective of this pilot study is to characterize the abnormal neuronal firing patterns~     of basal ganglia neurons and those in the premotor cortex in patients with~     treatment-resistant movement disorders undergoing deep brain stimulation (DBS) surgery.~      Study population~      Fifteen adult patients with treatment-resistant movement disorders who are undergoing deep~     brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.~      Design~      This is a physiology study of treatment-resistant movement disorder patients who have been~     scheduled for implantation of a deep brain stimulation device into the Nucleus accumbens.~     Prior to surgery, patients will learn a rewarded visual-motor task and undergo~     magnetoencephalography. The task will be repeated during DBS surgery, with collection of~     information on electrical activity including single neuronal unit and local field~     potentials. The task and MEG will be repeated 3-4 months after surgery. The collected data~     will be analyzed for coherence patterns during rest and rewarded movements.~      Outcome measures~      We plan to characterize and quantify the oscillatory activity present in motor circuits of~     treatment-resistant movement disorder patients during rewarded visually guided movements. We~     hypothesize that during visually guided movements, neuronal coherence will be significantly~     increased relative to resting periods. Thus, by better understanding the alteration in~     oscillatory patterns in these patients, we hope to develop better DBS stimulation paradigms~     in order to better treat this disease in the future.~   "
119997|NCT01485250|"~     Background:~        -  Individuals often participate in clinical trials to seek new therapies and free medical~          treatments for their illnesses or chronic conditions. However, less is known about the~          motivations of the healthy individuals who volunteer for research studies.~        -  Although many healthy volunteers participate in clinical trials for financial~          compensation, the particular risks involved in testing drugs that have not been tried~          in human clinical trials pose potential dangers for healthy volunteers in Phase I~          studies. More research is needed to understand the motivations of volunteers who~          participate in Phase I clinical trials.~      Objectives:~      - To evaluate the primary and secondary motivations of healthy participants in research~     studies.~      Eligibility:~      - Individuals at least 18 years of age who are healthy volunteers in selected Pfizer Phase I~     clinical trials.~      Design:~        -  Individuals who express interest in participating in specific Pfizer Phase I drug~          studies will be asked to complete a short questionnaire after completing the standard~          consent session for the study.~        -  Those who enroll in the trial will be asked to complete a second questionnaire prior to~          discharge from the study.~   "
119998|NCT01485237|"~     The main purpose of this study is to review the resource utilization of severe adult H1N1~     pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with~     pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in~     Winnipeg. Secondary objectives include, comparison of resource utilization to other similar~     disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will~     also look at the percentage of patients that required ICU care as compared to those who~     could be cared for on medical wards. The investigators will determine the resources used by~     both groups and compare. Finally the investigators will record the frequency of chronic~     comorbidities in hospitalized adult H1N1 patients.~   "
119999|NCT01485224|"~     Hereditary hemorrhagic telangiectasia (HHT) (OMIM 187300 and 600376), also known as~     Rendu-Osler-Weber syndrome, is an autosomal dominant disease and has a prevalence between~     1:5000 and 1:8000 in different populations. Clinically, the occurrence of mucocutaneous and~     gastrointestinal telangiectasias and of systemic arteriovenous malformations is commonly~     observed. Recurrent and severe epistaxis, due to the presence of telangiectasias in nasal~     mucosa, is the most common presentation of HHT, frequently leading to severe anemia~     requiring intravenous iron and blood transfusions. Although not life threatening, severe~     epistaxis has a great impact on quality of life in HHT patients and it represents the most~     important impediment in daily activities, that poses therapeutic challenge. Recently,~     angiogenesis has been implicated in the pathogenesis of HHT. Circulating concentrations of~     both TGF-beta and vascular endothelial growth factor (VEGF) are significantly elevated and~     therefore, anti-angiogenic substances may be effective in the treatment of vascular~     malformations in this disease. Thalidomide functions as a potent immunosuppressive and~     antiangiogenic agent. The aim of this study is to assess the clinical effects of thalidomide~     therapy on the severity of epistaxis in subjects with HHT who are refractory to standard~     therapies.~   "
120000|NCT01485211|"~     The purpose of this study is to evaluate the corneal pachymetric variations during and after~     corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and~     hypo-osmolar riboflavin solution in thin corneas.~   "
120002|NCT01485185|"~     This study will compare the effects of gabapentin alone, and gabapentin + donepezil given~     together in two types of experimental electrical pain tests in up to 48 healthy male~     subjects (after 24 recruited in the first cohort an interim analysis will be performed).~      The study is a randomized, double blind, placebo controlled, 3 was cross-over design study~     with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose~     and higher dose) or gabapentin (lower dose) with donepezil.~   "
120003|NCT01485172|"~     This study is a fixed dose, dose response study to characterize the dose response for~     ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and~     baseline assessments, subjects will be randomized to one of six final target treatment~     groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a~     screening period, an up-titration period, a maintenance period, a down titration period and~     a follow up period. This study utilizes change from baseline in the UPDRS motor score as the~     primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study~     (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed~     in order to establish the lowest maximally effective therapeutic dose.~   "
120004|NCT01485159|"~     This is a cross-sectional, observational study, investigating the point prevalence of~     Airflow Limitation in current or former smokers with established ischemic heart disease. The~     study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.~   "
120005|NCT01485146|"~     This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy~     subjects.~   "
120006|NCT01485133|"~     Water method with water exchange has been shown to reduce medication requirement and pain~     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated~     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope~     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion~     of air from the colon during insertion by omission of air insufflations and suction removal~     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy~     insertion in average patients and may enhance the success of difficult colonoscopy.~      Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the~     probable adhesion may change the anatomy and increase the discomfort of patients. We~     postulate that these patients may benefit from using the water method for colonoscopy. In~     this proposal we test the hypothesis that compared with conventional air insufflations the~     water method with water exchange significantly enhances the success rate of cecal intubation~     in patients with prior abdominal or pelvic surgery.~      The aim of the study is to compare the outcome of colonoscopy using the water method versus~     the conventional air method in patients with prior abdominal or pelvic surgery. The primary~     outcome is cecal intubation success rate. The secondary outcomes include cecal intubation~     time, maximum pain score during colonoscopy, overall pain score after colonoscopy and~     adenoma detection rate.~   "
120007|NCT01485120|"~     The purpose of this study is to establish the performance of a blood pressure cuff. The~     hypothesis is that the blood pressure reading from the cuff will provide similar blood~     pressure as a radial artery.~   "
120008|NCT01485107|"~     Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using~     the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days~     post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and~     tighten the skin of the décolleté region.~   "
120009|NCT01485094|"~     The purpose of this trial is to determine whether a novel analgesic is effective in treating~     of neuropathic pain caused by herpetic infection, surgery, or trauma.~   "
120010|NCT01485081|"~     The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel~     Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native~     coronary arteries.~   "
120011|NCT01485068|"~     The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting~     Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.~   "
120012|NCT01485055|"~     Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common~     development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells~     attack and damage your tissues and organs after transplant.~      Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have~     blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the~     skin or eyes), damage to other organs~      Steroids are the first line of treatment for acute GVHD. About a quarter of the patients~     that develop acute GVHD may not respond to steroid and have steroid refractory GVHD~     (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially~     life threatening condition. There is no standard treatment and it may not respond to~     treatment.~      The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD.~      Participants in this study will receive combination therapy (2 drugs: infliximab and~     basiliximab) once a week for four weeks.~   "
120013|NCT01485042|"~     3 STUDY RATIONALE Based upon the above rationale, the investigators propose a phase I study~     combining Pazopanib with TH-302 in advanced solid tumors. Pazopanib is FDA approved at a~     dose of 800mg per day. Using this dose ensures consistency with standard clinical use. It~     also ensures using the dose most likely to induce maximal hypoxia, which in turn will help~     ensure maximal local activation of TH-302 (a hypoxia activated prodrug). TH-302 can be given~     as monotherapy at a weekly dose of 575 mg/m2. When TH-302 is combined with full doses of~     various chemotherapeutics, the recommended dose of TH-302 has ranged from 240 to 480 mg/m2.~     Little overlapping toxicity between TH-302 and pazopanib is expected. However to ensure~     patient safety, the starting dose for the combination will be conservative and use the~     TH-302 dose found safe with the majority of cytotoxic agents, 340 mg/m2 given days 1,8, 15~     on an every 28 day cycle.~      Using a standard 3+3 design, the investigators will add increasing doses of TH-302 (340~     mg/m2, 480 mg/m2, 575 mg/m2 given weekly, 3 weeks on/1 week off (the standard TH-302 dosing~     schedule) to the full monotherapy dose of pazopanib (800 mg p.o daily) with expected accrual~     ranging from 12-18 subjects. Once the recommended phase II dose is identified, the~     investigators will then enroll an expanded cohort of approximately 12-18 (i.e. total of 30~     subjects overall) patients to better define the tolerability of this study drug combination.~      4 STUDY OBJECTIVES 4.1 Primary~        -  To define the maximal tolerated dose (if any) and the recommended phase II doses for~          the combination of pazopanib plus TH-302 in patients with advanced solid tumors 4.2~          Secondary~        -  To describe any dose limiting and non dose-limiting toxicities of this drug combination~   "
120029|NCT01484834|"~     The goal of this research was to investigate different intervention strategies in the~     workplace and their impact on quality of life of workers from companies in the city of~     Londrina, Parana, Brazil.~      The interventions were composed by exercise in the workplace and educational interventions.~   "
120014|NCT01485029|"~     Antibiotic consumption and antimicrobial resistance remain notoriously high in France,~     particularly among children below three years of age. In France, the pneumococcal conjugate~     vaccine was officially recommended for all children under two in 2003, and consequently~     changes occurred in Streptococcus pneumoniae serotype distribution. Bacterial carriage among~     children attending day-care centres may result from vaccine- and antibiotic-driven selective~     pressure with possible repercussions on the community.~   "
120015|NCT01485016|"~     The purpose of this study is to gather changes in physiological and biomechanical data~     during daily activity and sleep in epilepsy subjects.~   "
120016|NCT01485003|"~     The primary objective of the study is to determine which baseline and yearly response~     factors (clinical and para clinical) predict overall disease-free status at Month 12 and~     Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary~     objectives are: To identify prognostic factors at Baseline that predict overall disease-free~     status at Month 12, and to assess if yearly overall disease-free response factors predict~     overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse,~     Expanded Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36,~     and 48; To identify prognostic factors at Baseline that predict clinical disease-free status~     at Month 12, and to assess yearly clinical disease-free response factors that predict~     clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48;~     To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48~     on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement~     (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months~     12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1~     with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month~     48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity~     Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,~     36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]),~     capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality~     of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])~   "
120017|NCT01484990|"~     A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced~     Parkinson's Disease.~   "
120018|NCT01484977|"~     The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide~     (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with~     withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects~     not well controlled on their current regimen.~   "
120019|NCT01484964|"~     The purpose of this study is to determine the bioavailability and pharmacokinetics between~     two different formulations of ASP015K tablets and determine the food effect on the~     absorption of the new formulation.~   "
120020|NCT01484951|"~     The purpose of this study was to assess the safety and efficacy of switching to Azarga from~     prior pharmacotherapy in patients with open-angle glaucoma.~   "
120021|NCT01484938|"~     The purpose of this study was to describe mean differences in corneal staining (type and~     area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared~     to Baseline (Day 0).~   "
120022|NCT01484925|"~     This research study hopes to identify new molecular markers in the tissue of Barrett's~     esophagus that will help physicians better understand and manage this condition. Patients~     undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease~     (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken~     during the procedure.~   "
120023|NCT01484912|"~     The objectives of this study are to evaluate the efficacy, pharmacological activities and~     safety of STA-2 in the treatment of chronic stable angina.~   "
120024|NCT01484899|"~     Environmental factors may play a role in the genesis of pulmonary hypertension, especially~     in endothelial dysfunction. One widespread environmental factor associated with systemic~     endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not~     only a risk factor for systemic but also for pulmonary vascular diseases and herewith may~     interact with other risk factors such as a genetic background and associated conditions. The~     existing studies which deal with this subject are only small single center case control~     studies providing less data. Therefore a large European multicenter study is necessary.~      The investigators hypothesis are:~        -  a history of tobacco smoke exposure is highly prevalent in patients with PAH compared~          to the unaffected general population.~        -  a history of tobacco smoke exposure is more prevalent in patients with PAH compared to~          CTEPH.~   "
120025|NCT01484886|"~     In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a~     more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and~     possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will~     not affect the cardiac or pulmonary status of the patient.~   "
120026|NCT01484873|"~     The purpose of this study is to determine whether exenatide can cause weight loss in~     patients with a history of craniopharyngioma or other brain lesion.~   "
120027|NCT01484860|"~     This is a phase II study to see how useful study drug AUY922 is in patients with metastatic~     pancreatic cancer who have received or are intolerant to first-line chemotherapy.~      AUY922 is an intravenous drug that blocks a protein called heat shock protein 90 (Hsp90).~     Hsp90 works by keeping a number of other proteins stable and active, including many proteins~     that are involved in tumor growth and death. When Hsp90 is blocked from working, it is~     believed that many of the other proteins that it stabilizes will also be blocked, which will~     cause tumor growth to slow or stop.~      During the study, patients will visit the clinic once a week, every 4 week cycles to receive~     AUY922 intravenously and to have tests and procedures done. As part of the study, archived~     tumor tissue will be collected and patients will be asked to have blood samples taken for~     pharmacokinetic testing. Patients will be invited to take part in an optional banking of~     blood samples for future studies.~      The primary hypothesis of this study is that AUY922 improves disease control rate compared~     with what would be expected from best supportive care.~   "
120028|NCT01484847|"~     This is a study to assess how much of the investigational drug, PF-00298804, is in the blood~     stream over a period of time (called pharmacokinetic tests or PK) in patients with locally~     advanced head and neck squamous cell carcinoma who have a (gastrojejunostomy) feeding tube.~   "
120030|NCT01484821|"~     Sarcopenia is known to be associated with loss in muscle mass that results from a reduced~     number of muscle fibres, an atrophy of remaining muscle fibres, and an increased~     infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and~     treatments, sarcopenia impairs muscle function resulting in a higher risk of physical~     disability and death. The commonly used test for sarcopenia screening consists in a DEXA~     (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle~     information. In contrast, the mechanical properties of muscle tissue can be explored using~     an acoustic radiation force impulse (ARFI). The question remains whether muscle~     sonoelastography using ARFI imaging could be helpful for sarcopenia screening.~      For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years,~     both without any serious chronic disease, and patients ≥ 70 years presenting curative cares~     for cancer (Gr C).~      The volunteers belonging to the groups A and B will be followed during one day. The patients~     included in the group C will be followed during 6 months. For this latter group; the first~     visit (t0) will take place before treatment and the second visit will take place 6 months~     later (t6months) Volunteers will have clinical examinations (weight, stature, BMI,~     performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h~     dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk~     test, QLQ-C30 items relative to the fatigue symptom).~   "
120031|NCT01484808|"~     This is a review of previously published data from a large prostate cancer prevention study~     known as REDUCE. It is the investigators intention to review whether prostate specific~     antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and~     its grade and stage (severity).~   "
120032|NCT01484795|"~     Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major~     cause of mortality and morbidity in the world. The myocardial ischemia is often the~     precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive~     pressure has been used as a therapeutic modality.~      Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory~     and hemodynamic variables in patients with myocardial infarction.~      Materials and methods: ten patients with acute myocardial infarction, with Killip I~     classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation~     during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will~     be registered and electrocardiogram signals will be recorded for posterior analyses of HRV.~     Data will be collected before, during and after positive pressure ventilation.~      Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed~     by Tukey test.~   "
120033|NCT01484782|"~     The purpose of this study is to evaluate the feasibility of utilizing an interactive voice~     response (IVR) system to supplement hypertension self-management for patients in~     underdeveloped regions in Mexico and Honduras. Weekly disease assessment calls included~     hypertension self-management suggestions and support to patients. The impact on patients'~     blood pressure levels and other secondary outcomes were evaluated.~   "
120034|NCT01484769|"~     Collection of tissues for analysis from patients undergoing elective neck dissection.~      The hypothesis of the study is that specific genetic alterations occur in head and neck~     cancers that have spread to regional and/or distant sites, and these alterations can be~     identified from biopsy specimens to allow more accurate staging of tumor and better~     treatment planning.~   "
120035|NCT01484756|"~     Nutrient deficiency and immune dysfunction in older persons result in high prevalence of~     acute respiratory infection,which can lead to impaired nutritional status. The study~     objective was to determine the effect of multi micro-nutrient supplementation on nutritional~     and upper respiratory infection among apparently healthy community-dwelling elderly. The~     main hypothesis was whether daily multi micro-nutrient supplementation could reduce the~     incidence and prevalence of upper respiratory infection among apparently healthy~     community-dwelling older persons. Inclusion criteria were apparently independent healthy~     male and female older persons aged 60 years and over, not taking multi micro-nutrient~     supplementation over the last month. The study design was a community-based double-blind~     controlled trial involving 296 community-dwelling older persons aged 60 and above, in the~     Mampang Prapatan district, South Jakarta. Participants were randomized to receive either 40~     mg elemental zinc (as gluconate), 120 mg ascorbic acid, 6 mg B-carotene, 15 mg alpha~     tocopherol (as d-alpha-tocopheryl acid succinate) and 400 micrograms folic acid~     (intervention group) or 400 mg calcium carbonate (control group). Supplements were taken~     daily for six months, from August 2008 to March 2009. Nutritional and health status were~     measured before and after supplementation. Poisson regression analysis was used to evaluate~     the effects of daily multi micro-nutrient supplementation on the incidence and prevalence of~     upper respiratory infection.~   "
120036|NCT01484743|"~     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.~     The aim of present study is to use large-scale data from DVHD to uncover risk factors for~     readmission, reoperation (any indication), death and reoperation for recurrence after~     parastomal hernia repair.~   "
120037|NCT01484730|"~     The purpose of this research is to evaluate and validate the performance of non-invasive~     imaging modalities for assessment of skin. A pressure cuff occlusion will be used to~     stimulate blood flow dynamic that these instruments are designed to sense. The researcher~     currently plan to assess only basic feasibility of the imaging instruments.~   "
120045|NCT01484626|"~     The purpose of the study is to determine the safety and efficacy of the use of Bendamustine~     in combination with a commonly used combination chemotherapy to treat relapsed and~     refractory multiple myeloma. The study will be conducted in two phases. Participants in~     phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated~     dose of bendamustine is determined phase II of this trial will begin. Participants in phase~     II will receive the maximum tolerated dose of bendamustine in combination with standard of~     care chemotherapy.~   "
120062|NCT01484405|"~     There are two surgical approaches (incision types) used by surgeons who do total hip~     replacements. The purpose of this study is to determine which type of surgical approach~     (incision type) produces the best results for patients who have a total hip replacement.~      Null Hypothesis : There is no difference in complication rate, functional outcome, surgical~     time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or~     ORIF for femoral neck fractures.~   "
120063|NCT01484392|"~     The purpose of this study is to determine which medical, demographic, and health belief~     factors are associated with glaucoma therapy compliance.~   "
120038|NCT01484717|"~     Cigarette smoking remains the most common source of preventable morbidity and mortality in~     the United States, with in excess of $167 billion in economic costs per year. Contingency~     management (CM), in which tangible incentives are provided contingent on a target behavior~     like abstinence, is highly efficacious in improving substance abuse treatment outcomes and~     is receiving increased attention for smoking cessation. Expired carbon monoxide (CO) is the~     most common objective smoking status test used in smoking research and treatment.~     Unfortunately, multiple CO tests/day are typically required to detect all smoking and~     reinforce sustained abstinence. The resulting logistical and resource limitations greatly~     limit the application of this potentially powerful quit smoking toolset. This study~     addresses these limitations by examining the effectiveness of using interactive voice~     response technology (IVR) to implement CM. Smokers who want to quit (N = 90 randomized) will~     receive 2 quit preparation sessions based on public health guidelines for smoking cessation~     and set a target quit date. Participants will be randomly assigned to 1 of 2 treatment~     conditions: (a) IVR-S consisting of objective smoking status monitoring using IVR, telephone~     counseling and transdermal nicotine and (b) IVR-CM, consisting of the same monitoring,~     telephone counseling and transdermal nicotine plus IVR-based CM for smoking abstinence. It~     is hypothesized that abstinence rates will be higher in the IVR-CM condition compared to the~     IVR-S, supporting a combined IVR CM approach, and thereby greatly increasing the~     applicability of these powerful smoking cessation tools.~   "
120039|NCT01484704|"~     The purpose of this study is to determine how MRI changes the treatment and diagnostics of~     ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the~     study.~   "
120040|NCT01484691|"~     This will be a single center study of asthmatic subjects and healthy controls which will~     investigate mechanisms of asthma through detailed molecular analysis of airway tissues and~     fluids. The primary goal will be investigate the role of microRNAs in Th2-driven~     inflammation in asthma. The investigators hypothesize that asthma is associated with~     abnormal expression of miRNAs in T cells which favors differentiation into Th2-cells. The~     investigators further hypothesize that asthma is heterogeneous based on the presence and~     absence of Th2-driven inflammation and that abnormalities in T cell miRNA expression will be~     most prominent in a subgroup with high levels of Th2-driven inflammation (as assessed using~     molecular markers that the investigators have previously established). Finally, the~     investigators hypothesize that inhaled corticosteroids will normalize the T-cell miRNA~     abnormalities observed in asthma, as corticosteroids treat Th2-driven inflammation. The~     samples collected will also facilitate the pursuit of secondary analyses designed to~     investigate mechanisms of inflammation and remodeling in asthma as well as molecular~     phenotypes of asthma.~   "
120041|NCT01484678|"~     The purpose of this research study is to determine the potential of magnetic resonance~     imaging to monitor disease progression and to serve as an objective outcome measure for~     clinical trials in Duchenne Muscular Dystrophy (DMD). The investigators also hope to learn~     more about the changes that occur in muscles of the lower leg and arm in boys with DMD.~      The investigators will compare the muscles of ambulatory or non-ambulatory boys with DMD~     with muscles of healthy children of the same age and monitor disease progression in boys~     with DMD over a 5-10 year period. The amount of muscle damage and fat that the investigators~     measure will also be related to performance in daily activities, such as walking and the~     loss of muscle strength. In a small group of subjects the investigators will also assess the~     effect of corticosteroid drugs on the muscle measurements.~   "
120042|NCT01484665|"~     Decision-aids are tools to educate patients on a given topic so that they may better~     participate in shared-decision making in their health care. Given the complexities~     associated with PSA testing, many professional organizations have advocated for~     shared-decision making for PSA testing. However, no consensus exists as to how best educate~     and involve patients in the shared-decision making process. The goal of this study is to~     evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two~     different fashions in a primary care clinic with a large fraction of African-American~     patients. The investigators will evaluate the effectiveness of this program to educate~     patients on the risks and benefits of prostate specific antigen (PSA) testing, on their~     subsequent level of comfort with their decision about whether to receive PSA testing, and on~     the comfort level of physicians on their patient's decisions regarding PSA testing, and~     importantly, how well these strategies can be implemented into the daily work-flow of a~     clinic. If successful, this program may serve as a model for the broader implementation of~     such strategies across Minnesota and the country.~   "
120043|NCT01484652|"~     The primary objective of this study is to show the effectiveness of repeated doses of COV795~     versus placebo, using the summed pain intensity difference over the first 48 hours in~     subjects with acute moderate to severe pain following bunionectomy.~   "
120044|NCT01484639|"~     This is a multi-centre randomized controlled pilot trial of two transfusion strategies in~     high risk patients having cardiac surgery. This study will be conducted in 7 Canadian~     centers and 1 American centre. Patients allocated to a restrictive transfusion strategy~     will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively~     and postoperatively. Patients allocated to a liberal transfusion strategy will receive red~     cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and~     postoperatively in the intensive care unit, and less than 85 g/L on the ward.~      The primary objectives of this study are to determine 1) enrollment rates (patients~     enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3)~     protocol adherence (incidence and reasons for non adherence, lack of consent, rates of~     contamination and utilization of co-interventions). The secondary objectives are to~     determine 1) the mortality rate and the rate of the composite outcome for morbidity of~     renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing~     data as a measure of the feasibility of the case report form; and 3) the proportion of blood~     products utilized (red cells, platelets and plasma).~      The results of the multicentre pilot study will be used to 1) maximize enrollment rates to~     ensure timely completion of recruitment of a definitive large randomized controlled trial,~     2) maximize adherence rates, 3) determine event rates for sample size estimation for a~     definitive study, and to 4) optimize the case report form.~   "
120105|NCT01483846|"~     This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female~     subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on~     capsaicin-induced hyperalgesia will be assessed.~   "
120046|NCT01484613|"~     Cardiac resynchronization (CRT) therapy is well established for treatment of patients with~     severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony.~     Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is~     interruption of biventricular pacing. This might be caused by several conditions, including~     elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation~     (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's~     the aim of this prospective observational study to investigate efficacy and reliability of~     cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.~      Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV~     lead, at least one acceptable LV lead vector is available.~   "
120047|NCT01484600|"~     This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668~     Administered Subcutaneously to Healthy Volunteers.~   "
120048|NCT01484587|"~     The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a~     single subcutaneous (SC, under the skin) dose administered to Japanese participants with~     moderate to severe plaque psoriasis.~   "
120049|NCT01484574|"~     This is an open label, non-randomized, dose ranging study to evaluate the safety and~     efficacy of different doses of Stempeucel in critical limb ischemia patients.~   "
120050|NCT01484561|"~     The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of~     kidney function in patients with active rheumatoid arthritis (RA).~   "
120051|NCT01484548|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prophylaxis of~     visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the~     recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant~     GLA-SE.~   "
120052|NCT01484535|"~     This trial will study the effect of hematoma aspiration in patients with acute ankle~     fractures.~   "
120053|NCT01484522|"~     The purpose of this research study is to evaluate the immune response to the H1N1 influenza~     or flu vaccine. The immune response is how your body recognizes and defends itself~     against bacteria, viruses, and substances that may be harmful to the body.~      HIV-1 infected children typically respond more poorly to vaccines compared to uninfected,~     healthy children and so this study hopes to learn whether or not the body will successfully~     produce enough antibodies (proteins that fight infection) that will prevent or fight the~     H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine~     in children infected with HIV.~   "
120054|NCT01484509|"~     Leg artery disease is a common condition in which fatty deposits develop in the blood~     vessels that supply the legs. Many patients with leg artery disease experience a cramp-like~     leg pain during walking that is relieved by rest; this is called intermittent claudication.~     To help determine the severity of leg artery disease, patients may be questioned about how~     far they can walk before claudication pain forces them to stop. However, this information is~     usually of limited use because most patients poorly estimate their walking capacity. The~     investigators have developed a simple questionnaire to help estimate walking capacity in~     patients with leg artery disease. The purpose of this study is to test the validity and~     reliability of this questionnaire. By validity, the investigators mean the extent to which~     the questionnaire measures what it is supposed to measure (walking capacity). By~     reliability, the investigators mean the extent to which the questionnaire produces the same~     results over time when completed on two different days.~      The investigators hypothesise that the investigators simple questionnaire will be valid and~     reliable.~   "
120055|NCT01484496|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab~     administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).~   "
120056|NCT01484483|"~     This observational study, conducted by the Kenya Society for Hematology and Oncology, will~     develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical~     and pathological characteristics, treatment and clinical outcome will be collected from~     newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this~     registry cohort and followed up for a period of not less than five years.~   "
120057|NCT01484470|"~     While cord blood transplants have been performed safely in elderly patients, many still~     relapse. The investigators propose to intensify the preparative regimen for this patient~     group in an attempt to decrease relapses, and combine this with an ex vivo expanded~     Umbilical Cord Blood (UCB) unit.~   "
120058|NCT01484457|"~     Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric~     model predictive control can be developed and evaluated safely in patients with Type 1~     Diabetes Mellitus (T1DM) to control blood glucose concentrations.~      This study seeks to combine real-time continuous glucose sensing with automated insulin~     delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end~     result of this line of research will be an artificial pancreas that will provide~     around-the-clock glucose regulation through controlled insulin delivery in response to~     detected patterns of change in glucose levels.~   "
120059|NCT01484444|"~     BIOMARKER ANALYSES~        1. FNA Sample:~           From each enrolled patient who meets the inclusion criteria, FNA sample will only be~          taken .~           FNA will be carried out only in patients with feasible biopsy or FNA site. Ascites or~          pleural fluid will be collected for analysis~        2. Blood Samples From each enrolled patient who meets the inclusion criteria, blood~          samples will be collected. 3 mL blood sample will be collected .~        3. tumor tissue Archived Tumor Tissue (Slides) Samples Primary tumor and/or a metastatic~          lesion collected. Approximately 5 unstained slides (if available) are collected.~   "
120060|NCT01484431|"~     The purpose of this study to see how much study drug is in the blood after dosing children~     with pulmonary arterial hypertension (PAH) and to establish the correct dose for further~     clinical research.~   "
120061|NCT01484418|"~     Chronic low back pain often results in psychosocial and physical disability. A subgroup of~     these patients shows fear of (re)injury and avoidance behaviour leading to higher~     disability. The purpose of this study is to determine whether exposure in vivo is more~     effective in the treatment of fear avoidant chronic back pain patients than psychological~     treatment as usual (cognitive behavioural psychotherapy).~   "
120064|NCT01484379|"~     Following a personal observation and a retrospective analysis of the data, the investigators~     hypothesise that there is increased frequency of multiple gland disease in primary~     hyperparathyroidism in the elderly.~      This study will include patients over the age of 65, diagnosed with primary~     hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according~     to preoperative imaging. Surgery will begin with a focal parathyroid exploration as~     suspected followed by an exploration of the other gland at the same time. Data will be~     analysed to determine the frequency of multigland disease in this population.~   "
120065|NCT01484366|"~     The hypothesis is that intramedullary nailing of the ulna and plating of the radius will~     result in a superior outcome as evidenced by two primary end points:~        1. a lower rate of implant pain~        2. a lower re-operation rate to remove painful hardware.~   "
120066|NCT01484353|"~     The purpose of this study is to determine if a healthy lifestyle intervention can~     significantly improve blood sugar control in type 2 diabetics over a course of 3 months.~   "
120067|NCT01484340|"~     The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive~     anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking~     counseling alone among HIV-infected patients in South Africa, and to concurrently measure~     the prevalence of smoking among HIV-infected patients in South Africa.~   "
120068|NCT01484327|"~     Beta-blockers should be administered to all patients with heart failure stages II to IV~     NYHA. It should also be administered to patients with stage I after myocardial infarction.~     The low ejection fraction, especially after myocardial infarction is a strong indication for~     beta-blockers, as many studies indicate that administration of these drugs substantially~     reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and~     improve the operational phase for all categories of patients with heart failure. Since~     beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown~     these benefits and thus, only those have to be administered.~      The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol~     on cardiac function in patients with heart failure or reduced left ventricular ejection~     fraction after acute myocardial infarction.~   "
120069|NCT01484314|"~     Eltrombopag is a compound that may help stimulate the production of platelets. This drug has~     been used in treatment of low platelet counts caused by a disorder called idiopathic~     thrombocytopenic purpura and information from those other research studies suggests that~     Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma~     in this research study.~      In this research study,the investigators are trying to determine if Eltrombopag is effective~     in maintaining platelet counts in patients who are being treated for relapsed multiple~     myeloma.~   "
120070|NCT01484301|"~     The purpose of this study was to assess the impact of opioid tolerability-related issues~     experienced by Canadian chronic pain patients. Approximately 170 patients were enrolled from~     16 recruiting centers across Canada. Eligible patients had a diagnosis of non-malignant,~     chronic pain requiring continuous use of strong opioids (>=4 days per week). Recruitment was~     initiated by physicians during routine care appointments at family or pain medicine~     practices. Patients were then directed to a website where they provided consent and~     completed an anonymized, password-protected, web-based survey that could be completed at~     home. This weekly online questionnaire was designed to document their chronic pain~     experience over a 12-week period. At the end of the 12-week study, physicians were asked to~     retrospectively complete information about pain treatments, over-the-counter (OTC)~     medication use for pain and opioid-related gastrointestinal (GI) side effects, as well as~     co-morbid conditions for each patient.~   "
120071|NCT01484288|"~     The purpose of this clinical investigation is to evaluate the efficacy and safety of the~     CVRx Barostim Neo System in the treatment of patients with heart failure.~   "
120072|NCT01484275|"~     The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with~     placebo (an inactive substance that is compared with a drug to test whether the drug has a~     real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma~     (SMM).~   "
120073|NCT01484262|"~     This study is conducted in Europe. The intention of this health service research study is to~     obtain data from daily routine to evaluate the quality of life and the costs of the disease~     for patients with type 2 diabetes mellitus.~   "
120074|NCT01484249|"~     This study was designed as a First In Man (FIM) trial to evaluate the feasibility and~     technical capability of the Claret CE Pro System in delivering two embolic filters to the~     brachiocephalic artery and the left common carotid artery during a Transcatheter aortic~     valve implantation (TAVI) procedure in order to protect the neurovasculature from debris~     liberated during the procedure.~   "
120075|NCT01484236|"~     RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine~     the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic~     information and information concerning the timing and modalities of diagnosis.~      Based on the registry, we will set up a prospective cohort of patients. The database will~     include detailed medical information, particularly regarding progression of the respiratory~     function.~   "
120076|NCT01484223|"~     The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal~     intervention (BCI) in patients with somatization symptoms which has an effect on the~     perceived quality of life front conventional intervention.~   "
120077|NCT01484210|"~     The aim of this study is to establish the therapeutic equivalence between the test~     (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference~     formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the~     Fluticasone/Salmeterol combination.~      The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover~     fashion.~   "
120078|NCT01484197|"~     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of~     two different formulations of indacaterol maleate, both administered via the Concept1~     device. The study aims to determine whether the novel formulation has a similar clinical~     profile as the established formulation.~   "
120106|NCT01483833|"~     To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied~     twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.~   "
120079|NCT01484184|"~     As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy~     candidate called SPINALON has been identified and is currently under development for its~     capacity to temporarily induce episodes of involuntary locomotor movements. The primary~     objective of this Phase I/IIa study is to assess safety and tolerability of a single~     escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal~     cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also~     be sought.~   "
120080|NCT01484171|"~     To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination~     with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched~     donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid~     leukemia (AML).~   "
120081|NCT01484158|"~     There are growing evidences that gait speed is inversely associated with all causes~     mortality especially cardiovascular mortality among the elderly. The purpose of this study~     is to evaluate the predictive value of gait speed for cardiovascular events in patients~     after ST-segment elevation myocardial infarction (STEMI).~   "
120082|NCT01484145|"~     The purpose of this study is to determine how much terbinafine is delivered to the nail bed~     after treatment with a number of modifications to a previously studied method for~     iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a~     small electric charge to deliver drug across skin and nails.~   "
120083|NCT01484132|"~     The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite~     for its effects on urinary bisphenol-A levels. The study will enroll approximately 139~     children recruited from study-affiliated clinical sites in New England.The primary aim of~     CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after~     composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers~     and has been shown to have harmful effects in toxicological studies in laboratory animals.~     Currently it is unknown whether dental composite restorative materials containing monomers~     that are derived from BPA result in chronic low-dose BPA exposure in children.~   "
120084|NCT01484119|"~     This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and~     elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.~   "
120085|NCT01484106|"~     The primary objective of this study is to test whether a fluid resuscitation protocol guided~     by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined~     by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in~     sepsis patients presenting to the Emergency Department without evidence of shock.~   "
120086|NCT01484093|"~     Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000~     cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being~     done to better understand how to treat MCL.~   "
120087|NCT01484080|"~     The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF~     1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial~     design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and~     subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal~     blockade).~   "
120088|NCT01484067|"~     If a person qualifies to participate in this study, they will have an equal chance of being~     assigned to either of two groups. One group will receive a patch that they will need to~     carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put~     the patch over the sore. The other group will not get a patch, but will need to follow the~     other instructions anyway.~      When a subject's outbreak begins, they will need to return to the study center within 24~     hours. Then they will return according to the appointments given within 10 days. If the~     study staff sees that their sore has healed enough before 10 days, subjects will be told~     that they don't need to return again.~      As long as subjects are in the study, they will need to answer a few simple questions every~     day on a card or booklet called a diary, starting the first day of their outbreak. If a~     subject is assigned to the patch group, they must wear the patch all the time, taking it off~     only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when~     they are asked to remove the patch so the sore can be checked.~      During the study subjects will be allowed to use paracetamol for pain, but no other~     treatments or medicine. If they use paracetamol, subjects must record it in their diary. The~     study will be stopped, and there will be no subject visits or treatments during the end of~     year holiday break. If a subject experiences an outbreak during the holiday, they may follow~     their usual treatment routine.~   "
120089|NCT01484054|"~     To evaluate and compare the performance of a new contact lens to a marketed contact lens.~   "
120090|NCT01484041|"~     This study is for women with confirmed hormone receptor positive HER-2 negative advanced~     breast cancer with evidence of disease resistance to an aromatase inhibitor.~      The purpose of this study is to determine how well these medications work together and/or if~     they have any side effects in patients with hormone-receptor positive metastatic breast~     cancer who have demonstrated progression of disease after first line hormonal therapy.~      This research is being done to determine if taking an already approved medicine (aromatase~     inhibitor) in combination with a new medication (dovitinib) results in better outcomes for~     patients with this disease.~      Both dovitinib and an aromatase inhibitor are pills that will be taken at home.~   "
120091|NCT01484028|"~     This study will serve to evaluate and compare the performance of two new lenses to a~     marketed lens.~   "
120092|NCT01484015|"~     This randomized pilot clinical trial studies how well giving prolonged infusion compared to~     standard infusion of cefepime hydrochloride works in treating patients with febrile~     neutropenia. Giving cefepime hydrochloride over a longer period of time may be more~     effective than giving cefepime hydrochloride over the standard time.~   "
120107|NCT01483820|"~     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for~     neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been~     approved by the Food and Drug Administration. This investigational drug is called TPI 287.~     This study will look at the tumor's response to the study drug, TPI 287, as well as the~     safety and tolerability of the drug.~      TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in~     three different animal species. TPI 287 has been tested in humans in four clinical trials,~     and approximately 100 subjects with various types of cancers have received the drug,~     including a pediatric population in our previous Phase I trial.~   "
120093|NCT01484002|"~     This retrospective study will investigate the changes that occur in ultrahigh molecular~     weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement~     patients. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR),~     Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink~     density measurements will be evaluated as a function of distance away from the articular~     surface and the rim of the implant. Gel and hydroperoxide contents will also be evaluated.~     The objective is to characterize the in vivo and ex vivo changes that occur with~     cross-linked and conventional polyethylene bearings sterilized by methods that do not~     involve radiation. The investigators hypothesize that polyethylene absorbs lipids in vivo~     but experiences negligible oxidation or reductions in polymer crosslinking until it is~     explanted and stored at room temperature with access to ambient air.~   "
120094|NCT01483989|"~     The purpose of this study is to measure corneal epithelial changes in dry eye subjects using~     a novel lubricant eye gel.~   "
120095|NCT01483976|"~     The objective of this study is to verify changes in protein metabolism after ingesting a~     oral medical nutritional supplement.~   "
120096|NCT01483963|"~     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of~     AA4500 in the treatment of adhesive capsulitis.~   "
120097|NCT01483950|"~     This study is non-interventional study of patients who are treated with any HMGCoA reductase~     inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and~     Herzegovina for at least 6 months. Data collection for each patient will take place at a~     single visit. The investigators will complete Case Report Form (CRF) with patient's~     demographic, the presence of the factors for high cardiovascular risk, current treatment,~     cholesterol value as well as with further treatment decision.~   "
120098|NCT01483937|"~     Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment~     Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance~     physical therapy for rehabilitation of patients who fall as a result of vestibular inducted~     disequilibrium.~      Study participants will receive regular physical therapy, and some will use the SEMD device~     while receiving usual care vestibular-balance physical therapy. The device is an elastic~     belt that holds eight small battery powered vibrating disks. When using the device, you will~     sit or stand on a force platform that measures body sway. That movement information is sent~     to a computer which then sends the information to you via the vibrating disks. The vibrating~     disks are similar to a vibrating cell phone: you can feel the vibration but it is not~     uncomfortable. You can also see your sway movement on the computer screen. Some tests and~     activities will be paced with a beeping sound.~      The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and~     conventional vestibular-balance physical therapy as reported by treating physical~     therapists' by counting number of skills acquired in a treatment session, and the amount of~     time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance~     test scores when using the SEMD as an adjunct to conventional vestibular-balance physical~     therapy; 3. Determine the difference in vestibular habituation between physical therapy plus~     SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate~     reduction in fall occurrence when using SEMD as an adjunct to conventional~     vestibular-balance physical therapy; 5. Determine the patient's perception of quality of~     life between physical therapy plus SEMD and conventional vestibular-balance physical~     therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step~     quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with~     SEMD and conventional vestibular-balance physical therapy .~      In addition to primary and secondary outcome measurements, efficiency of skill acquisition,~     devised for this study, will be evaluated by tracking the number of skills and length of~     time needed to acquire each skill for each physical therapy session using the Patient Skill~     Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder~     Rifle-Return to Stand as intervention outcome, also devised for this study, will be~     evaluated with pre test to post tests Modified Functional Independence Measure - Motor~     (MFIM-Motor). These measurements were devised for this study, and will be evaluated for~     informational purposes only.~   "
120099|NCT01483924|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with~     moderate to severe chronic plaque psoriasis.~   "
120100|NCT01483911|"~     ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The~     purpose of this first-in-man study is to determine the safety, tolerability and~     pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in~     healthy male volunteers.~   "
120101|NCT01483898|"~     This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a~     patient-specific expanded multicellular therapy, for the treatment of patients with critical~     limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI~     patients who have no option for revascularization procedures. All patients randomized will~     undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office~     procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control~     into their pre-identified index leg. Patients will be followed for 18 months.~   "
120102|NCT01483885|"~     Physiotherapy offers a range of therapeutic modalities for pain management including~     Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and~     Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS,~     CI and Acupuncture in a cold-induced pain model.~   "
120103|NCT01483872|"~     Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the~     use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in~     addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated~     bacteremia via a catheter-salvage strategy.~      The investigators plan to randomize 102 patients with hemodialysis catheter-associated~     bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for~     treatment of their infection. Additionally, patients randomized to the interventional arm~     will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and~     heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive~     only an anticoagulant solution as a catheter lock which is standard of care - this can be~     either heparin or citrate (depending on what agent is standard of care for a particular~     patient). The main outcome of interest is successful treatment which is defined as a~     resolution of the current episode of bacteremia as well as lack of recurrent bacteremia~     within 90 days of follow-up.~   "
120104|NCT01483859|"~     Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly~     introduced noninvasive tool that generates an elastic wave using a vibrator applied to the~     thoracic wall at the level of the right lobe of the liver and measures the prolongation~     velocity of the wave, which is directly associated with liver stiffness (LS). Although~     recent advances in surgical techniques and perioperative management have made with~     established perioperative management have now made it possible to perform hepatectomies as a~     safe procedure with minimum mortality, the possibility of massive blood loss and resultant~     transfusion during hepatectomy still exist. The objective of this research was to identify~     the role of liver stiffness measurement for the prediction of intraoperative blood loss and~     postoperative recovery after elective right hepatectomy.~   "
120108|NCT01483807|"~     This study is designed to examine the effects of speech therapy on ability to produce speech~     sounds in persons with acquired apraxia of speech.~   "
120109|NCT01483794|"~     This is an observational study looking at the characteristics of patients consulting for~     genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso,~     Chile. The objectives are: to have an epidemiological profile, estimating cost of the~     disease for the health system and the patient and analyzing possible psychosocial~     consequences of the condition for the patients.~   "
120110|NCT01483781|"~     The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and~     renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking~     metformin and being treated for high blood pressure.~   "
120111|NCT01483768|"~     Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal~     iron absorption of morbid obese subjects.~      Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in~     adipose tissue and that its expression is increased in morbidly obese subjects. The working~     hypothesis is that this increase could explain the high prevalence of systemic iron~     depletion observed in obese patients.~      Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese~     patients on the intestinal absorption of iron (evaluated by measuring the expression of iron~     transporters in the duodenum)~   "
120112|NCT01483755|"~     The investigators previously reported that angioplasty postconditioning reduces infarct size~     (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital~     admission. Animal studies have suggested that the time window for applying brief episodes of~     ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow,~     i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window~     might be larger in humans, i.e. whether STEMI patients might be protected several minutes~     after undergoing spontaneous reperfusion before admission coronary angiography.~      Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade >~     1 were eligible for that study. Angioplasty postconditioning was completed as already~     published and infarct size was assessed by measuring cardiac enzymes release.~   "
120113|NCT01483742|"~     This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and~     antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys~     (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added~     to the combination treatment in prior null responder patients with chronic hepatitis C~     genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg~     orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously~     weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048~     1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.~   "
120114|NCT01483729|"~     This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will~     evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In~     Part 1, subjects will be randomized to receive single oral doses of one of three tablet~     formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day~     washout between periods. In Part 2, subjects will be randomized to receive single oral doses~     of one of three tablet formulations of ritonavir plus the reference formulation of~     danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is~     up to 30 days.~   "
120115|NCT01483716|"~     Obesity is an escalating problem in the UK and a proportion of these patients have a~     condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with~     symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. Previous~     research has shown that patients with this condition tend to use healthcare services more~     frequently and are often at risk of other diseases such as diabetes mellitus and high blood~     pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a~     mask ventilator that patients use overnight to improve oxygen levels and remove carbon~     dioxide (the waste gas of breathing), however this does not fully treat the underlying~     problem. The research group has shown that NIV helps improve activity and contributes to~     weight loss in this group of patients. The aim of this research will be to investigate the~     effect of an exercise and nutrition programme in addition to NIV on weight loss and activity~     levels compared to NIV alone.~   "
120116|NCT01483703|"~     The purpose of this study is to determine whether reflections of light can be used to~     provide real-time pictures of blood vessel formation around infants' heads. This study~     device is called laser speckle imaging.~   "
120117|NCT01483690|"~     This is a pilot study using decitabine and vorinostat before and during chemotherapy with~     vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with~     acute lymphoblastic leukemia (ALL).~   "
120118|NCT01483677|"~     The investigators believe that subjects who practice on the Nintendo Wii will improve their~     laparoscopic skills more than those who practice on the Playstation2.~   "
120119|NCT01483664|"~     The purpose of this study is to improve the communication skills of physicians who~     transition lymphoma cancer patients from the end of treatment to survivorship.~   "
120120|NCT01483651|"~     The purpose of this research study is to test how different levels of insulin block the~     effect of glucagon. Insulin is a hormone that lowers blood glucose. Glucagon raises blood~     glucose. Both are natural hormones made by people without diabetes. Sensor-based blood~     glucose control studies have been done by our research group using glucagon in small doses~     to prevent hypoglycemia (low blood sugar). However, sometimes glucagon does not work to~     raise blood sugar. The investigators believe this is because of too much insulin in the~     body. This study will help determine how different levels of insulin in the body affect the~     ability of glucagon to raise blood sugar.~   "
120121|NCT01483638|"~     The purpose of this study is to evaluate the maintenance therapy with axitinib in patients~     with metastatic colorectal carcinoma~   "
120122|NCT01483625|"~     The aim of the study is to investigate whether the early introduction of maintenance~     bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on~     the recovery of symptoms. It also represents an opportunity to identify COPD patients~     earlier in their disease state and start maintenance therapy, if appropriate.~   "
120136|NCT01483443|"~     This is a prospective phase III trial to define the role of oophorectomy in metastatic~     colorectal cancer patients with ovarian metastasis.~   "
120137|NCT01483430|"~     In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on~     blood pressure in prehypertensive or stage I hypertensive patients.~   "
120123|NCT01483612|"~     BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by~     anovulatory cycles, but it is also associated with reduced fertility even in ovulatory~     women. Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments~     and reduces their efficacy. In addition to fertility disorders, obesity increases~     significantly the risks of many complications of pregnancy, delivery and neonatal health.~     However, a modest loss of 5-10% of total body weight can restore ovulation and improve~     pregnancy rates.~      OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management~     of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary~     AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on~     fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group~     and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and~     other measures of cost-effectiveness, of this program compared to the control group and~     tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities~     to relevant stakeholders in the health care and public health sectors.~      METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in~     infertile women, we will gather a Committee composed of members of our interdisciplinary~     research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these~     objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27~     kg/m²), consulting at the CHUS fertility clinic will be randomized to our lifestyle program,~     and will suspend fertility treatments for six months, or to standard fertility treatments,~     which are directly initiated. The results obtained will also be compared to those of women~     with the same criteria who will consult in 3 tertiary AHR clinics not offering a similar~     lifestyle management program.~      IMPACT: This project is very important as it will generate new knowledge about the~     implementation, impacts and costs of a new lifestyle management program in obese infertile~     women. Our project will obtain valuable data on implementability of such a program; on~     benefits with regard to lifestyle, fertility and maternal and foetal complications during~     pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness~     ratio.~   "
120124|NCT01483599|"~     The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the~     treatment of patients with moderate to severe plaque psoriasis.~   "
120125|NCT01483586|"~     This research is being done to evaluate the safety and efficacy of the investigational~     Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.~   "
120126|NCT01483573|"~     This study was designed to answer 3 primary research questions:~        1. In adults with low back pain, reduced SLR ROM (Range of Motion) and a positive~          sensitized SLR (Straight leg raise) test, does neurodynamic mobilization result in~          greater SLR ROM, pain reduction and perceived improvement than muscle stretching?~        2. In adults with low back pain, reduced SLR ROM and a negative sensitized SLR test, does~          muscle stretching result in greater SLR ROM, pain reduction and perceived improvement~          than neurodynamic mobilization?~        3. In adults with low back and reduced SLR, does neurodynamic mobilization or muscle~          stretching result in greater SLR ROM, pain reduction and perceived improvement~          irrespective of the outcome of SLR sensitization?~      The research hypotheses are threefold:~        1. Subjects determined to have nerve-related pain and ROM restrictions by a positive~          sensitized SLR test would benefit more from neurodynamic mobilization than muscle~          stretching.~        2. Subjects determined to have muscle-related pain and ROM restrictions by a negative~          sensitized SLR test would benefit more from muscle stretching than neurodynamic~          mobilization.~        3. Subjects would benefit the same from muscle stretching and neurodynamic mobilization~          when not matched on the outcome of the SLR sensitization.~   "
120127|NCT01483560|"~     The trial is conducted in the UK, Australia, Canada, Denmark and the Netherlands. The aim is~     to test whether 3 years treatment with metformin added to titrated insulin therapy (towards~     target HbA1c7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid~     IMT, in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for~     cardiovascular disease.~   "
120128|NCT01483547|"~     The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien)~     in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI)~     and Return of Consciousness (ROC) in neurosurgical patients are compared to those of~     non-neurosurgical patients, during routine anesthesia procedures.~   "
120129|NCT01483534|"~     The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or~     TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM~     will also be evaluated through confirmation of successful application of TLD Therapy.~   "
120130|NCT01483521|"~     This is a proposed home visitation program for families of children with externalizing~     behaviors who are on the wait list for psychiatric assessment at BC Children's hospital. The~     aim of this program is to implement and evaluate a home visitation strategy in order to~     support those waiting up to four months to consult a psychiatrist.~   "
120131|NCT01483508|"~     The purpose of this study is to determine whether or not the intake of dietary procyanidins~     (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.~   "
120132|NCT01483495|"~     The brain is such a metabolically active organ that it consumes about 20% of oxygen burned~     every minute by an average adult even though it only contributes about 2% of the body~     weight. As a result, the brain produces a disproportionately high amount of CO2 every minute~     in comparison with the rest of the body.~   "
120133|NCT01483482|"~     Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures~     seen in orthopedics.~      There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle~     fractures. Conservative treatment has, traditionally, been the preferred treatment but~     recent studies have shown higher incidences of non-union and symptomatic malunion associated~     with conservative treatment. Primary surgery has in several studies been associated with~     high success rates and few complications but there is no compelling evidence towards~     superior results after primary surgery.~      The objective of this randomized study is to compare conservative treatment (sling) with~     primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.~   "
120134|NCT01483469|"~     This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as~     radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to~     human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III,~     positron emission tomography (PET) assessments of specific uptake of the radiotracer and~     whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part~     IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single~     intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is~     up to 4 weeks.~   "
120135|NCT01483456|"~     Falls among elderly inpatients are common, multifactorial and associated with a significant~     increase of complications and morbidity. According to a recent Cochrane review, the~     effectiveness of fall prevention program has been assessed in community-dwelling and in long~     stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study~     aims to measure the impact of a multidisciplinary prevention program on falls in elderly~     inpatients.~   "
120139|NCT01483404|"~     This project investigates wether the intra-capsular hematoma, that often occurs after~     fracture of the femural neck, decreases the capillary blood flow of the caput femoris.~      During operation the measuring device of the O2c-machine in placed on the joint capsula~     first and afterwards, after surgical opening of the capsula, on the femur directly. The~     integral of the microcirculation of both parts of the femur is measured in both settings. So~     the capillary blood flow is measured with the hematoma still in situ, eventually putting~     pressure on the caput femoris and after the capsula has been opened, the pressure relieved~     and the hematoma removed. Both measurements are compared for each patient.~      The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod~     is packed in a sterile tube to prevent any contamination of the operation site.~   "
120140|NCT01483391|"~     Children or teens with mood swings or depression who have a parent with bipolar disorder are~     at high risk for developing bipolar disorder themselves. This study will test a family-based~     therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk~     children (ages 9-17). In a randomized trial, the investigators will compare two kinds of~     family-based treatment (one more and one less intensive) on the course of early mood~     symptoms and social functioning among high-risk children followed for up to 4 years. The~     investigators will examine the effects of family treatment on measures of neural activation~     using functional magnetic resonance imaging.~   "
120141|NCT01483378|"~     The purpose of this study is to determine if vaccination rate of eligible patients at a~     major urban public hospital will increase by having ophthalmologists screen patients for~     eligibility and a nurse administer the vaccine in the General Eye Clinic.~   "
120142|NCT01483365|"~     The investigators are going to examine prospectively the need of luteal support after~     NC-FET.~   "
120143|NCT01483352|"~     The Accu-Chek DiaPort system enables continuous intraperitoneal insulin infusion (CIPII):~     that is, infusion of insulin into the peritoneal cavity using an Accu-Chek insulin pump and~     an infusion set. The Accu-Chek DiaPort consists of a metal body with a catheter that is~     placed in the abdomen. The opening of the port is raised above the surface of the skin about~     5 millimeters, while a flower-shaped plate is placed under the skin, providing stability for~     the port. The port has been designed for those diabetics who cannot benefit fully from~     subcutaneous insulin infusion. The primary objective of the study is to assess the~     suitability of Accu-Chek DiaPort to perform continuous intraperitoneal insulin delivery. The~     data collection focuses on the condition of tissue around the port after the implantation,~     possible peritoneal reactions to the port system, and the peritoneal delivery of insulin.~     Secondary objectives are the assessments of therapeutic performance and successful~     implementation of design requirements. In total 12 Patients will participate in this open,~     mono-centre, single-arm, interventional clinical trial. The study lasts 9 months (without~     run in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last 6~     month until the end of the study. During the study, seven visits are planned. The screening~     visit can take place up to 3 weeks before study start. At the implantation visit which can~     last up to 5 days the port will be implanted. After the implantation insulin therapy will be~     adjusted for CIPII and the patients will be trained for handling and daily care of the~     Accu-Chek DiaPort system. To check the functionality of the system, the first control visit~     will take place 2 weeks and the second control visit 6 weeks after the implantation. At the~     week 12 visit, the most important parameters will be collected for the phase I report. The~     following visits take place 6 and 9 months after the implantation.~   "
120144|NCT01483339|"~     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.~     However, the majority of treated patients remain symptomatic. The metacognitive therapy by~     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this~     study is to investigate this approach with a randomized controlled trial by comparing~     metacognitive therapy with exposure and response prevention for obsessive-compulsive~     disorder.~   "
120145|NCT01483326|"~     This observational study will evaluate the long-term efficacy and safety of~     RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further~     patients with moderate to severe rheumatoid arthritis starting or receiving~     RoActemra/Actemra. Data will be collected from each patient for up to 4 years.~   "
120146|NCT01483313|"~     Animal studies showed that many general anesthetics might result in neuron apoptosis and~     neurocognitive impairment in the developing brain. However results from human studies are~     conflicted. In present study, the investigators examined the association between early~     exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence~     using the Wechsler Intelligence Scale for Children.~   "
120147|NCT01483300|"~     Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line~     treatment for metastatic breast cancer patients, especially for those previously treated~     with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug~     platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and~     gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of~     gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast~     cancer.~   "
120148|NCT01483287|"~     IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is~     characterized by recurrent pain and/or discomfort, altered stool form, and abdominal~     distension. It has been established that food items such as beans, peas, lentils, peppers,~     and onions can increase gas production. What these have in common is that they all contain~     large amounts of complex carbohydrates. The enzymes in the small intestine are not able to~     fully digest these large molecules, which in turn are fermented by the colonic microflora.~     This fermentation is conducted through the production of short chain fatty acids and gases~     such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break~     down these indigestible carbohydrates to galactose and sucrose in the small intestine and to~     facilitate the absorption and minimize the gas production from bacteria in the colon.~      The aim of this study is to assess if the gastrointestinal symptoms, above all problems from~     gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin~     capsules) is ingested with food.~   "
120149|NCT01483274|"~     Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell~     transplant cell receive decitabine to up regulate cancer antigen expression, followed by a~     donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are~     pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.~   "
120150|NCT01483261|"~     To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy~     with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo.~     This study seeks to fill this gap by designing, implementing and testing such an~     intervention using both an intervention and waiting list control group.~   "
120169|NCT01483014|"~     This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant~     treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of~     imatinib to convert a tumor from inoperable to operable.~   "
120151|NCT01483248|"~     Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage~     liver diseases. However, the critical shortage of donor organs, high cost, and the problem~     of immune rejection limit its clinical application, and even some patients on the waiting~     list will never survive to receive a matched liver. Stem cell transplantation instead of~     conventional medical therapy or orthotopic liver transplantation will be a promising~     alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs)~     are generally thought of as an autologous source of regenerative cells in previous~     studies.In this study, the safety and efficacy of menstrual blood-derived stem cells~     transplantation for patients with liver cirrhosis will be evaluated.~   "
120152|NCT01483235|"~     Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart~     disease such as high blood pressure, weight control, exercise and diet in order to decrease~     the chances of having heart problems in the future. These programs decrease morbidity and~     mortality but face important challenges: 1) Long waiting lists to participate in these~     programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year.~     Patients usually wait one to three months to start the program. 2) There is a vast~     heterogeneity of patients within the same program, from those that have never experienced~     heart problems to those that have already had a heart attack, chest pain or stroke.~     Therefore, patients with different medical problems receive the same treatment. 3)~     Facilities can be inconveniently located which leads to transportation difficulties, 4) The~     program is time consuming and classes are held in working times, 5) Shortly after~     completion, patients seem to lose what they have gained in the program. These caveats need~     to be addressed to improve the efficacy, delivery and capacity of sCRP for the increasing~     population of patients with heart disease.~      The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the~     standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart~     disease as well as patients that already suffer from this condition, including those at~     higher risk. The rCRP will offer the same services as the sCRP; the only difference is the~     number of hospital based exercise sessions. While the sCRP offers 32 hospital based~     supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The~     rCRP would be a 'middle of the road alternative program' that would have the benefits of a~     hospital based program and the flexibility of a home based intervention. The rCRP would~     offer an alternative for patients that do not need constant supervision and would allow the~     sCRP health care team to focus on those patients who have more serious heart conditions. The~     rCRP would be a unique intervention because it integrates a less intensive cardiac~     rehabilitation into the pre-existing sCRP model. This alternative would help overcome the~     caveats of standard cardiac rehabilitation programs.~   "
120153|NCT01483222|"~     The main objective of this study is to investigate the efficacy of two different design~     characteristics of lumbar support for low back pain prevention in hospital nurses.~   "
120154|NCT01483209|"~     The goal of this project is to determine if performing a chemical sympathectomy by~     injecting botulinum toxin A in critically ill patients on vasopressors can treat digital~     ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of~     concept. We propose to study patients in the intensive care units of Duke Hospital who,~     secondary to exposure to vasoactive medications used to maintain acceptable blood pressures,~     have developed signs and symptoms of digital ischemia. A paired T-test will be used to~     compare pre- and post-injection Laser Doppler measurements for the experimental hand. We~     will again use a paired t-test to compare the experimental hand against the contralateral~     control hand. There were no major adverse events reported by the product information sheet~     or in other related studies of Botox for digital ischemia.~   "
120155|NCT01483196|"~     This clinical trial studies vascular and cognitive assessments in patients with breast~     cancer undergoing chemotherapy after surgery. Learning about vascular and cognitive function~     may help plan treatment and improve the quality of life of breast cancer patients.~     Transcranial Doppler ultrasound (TCD) may help study the side effects of chemotherapy in~     breast cancer patients and allow doctors to plan better treatment~   "
120156|NCT01483183|"~     The purpose of Part 1 of this study is to determine the maximally tolerated dose of~     OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).~      The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of~     OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.~   "
120157|NCT01483170|"~     This trial will study the tolerability and pharmacokinetic of fexinidazole using two~     different dosage regimen of repeated administrations. The drug is administered to human~     healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with~     a loading dose during 4 days.~   "
120158|NCT01483157|"~     Resistance exercise plus vascular occlusion may induce greater improvements in strength and~     muscle mass resistance training alone. The investigators speculate this training strategy~     could be beneficial in patients with rheumatoid arthritis.~   "
120159|NCT01483144|"~     The purpose of this randomized, double-blind, Phase III trial is to determine if the~     combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single~     agents in delaying time to the first occurrence of any FAP-related event. This includes: 1)~     FAP related disease progression indicating the need for excisional intervention involving~     the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes~     progression to more advanced duodenal polyposis, cancer or death.~   "
120160|NCT01483131|"~     Resistance exercise plus vascular occlusion may induce greater improvements in strength and~     muscle mass than resistance training alone. The investigators speculate this training~     strategy could be beneficial in patients with osteoarthritis.~   "
120161|NCT01483118|"~     The primary purpose of this follow-up study is to determine if cinnamon can restore~     menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a~     secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on~     insulin resistance in larger group of study subjects.~      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing~     age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming~     pregnant. The syndrome can also be associated with more serious conditions such as heart~     disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome,~     scientific studies showed that having too much insulin can be one of the reasons. In fact,~     almost every overweight woman with PCOS has been found to have high insulin levels.~      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may~     also reduce the body's insulin level. Another study showed that daily use of cinnamon for~     forty days lowered the blood sugar level in patients with diabetes. Our own study also~     showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with~     PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more~     regular periods.~      All patients will eat a balanced diet containing 1800 calories per day, but half of the~     patients in the study will take pre-made cinnamon extract pills three times a day, while the~     other half will take placebo pills (pills with no cinnamon extract) three times a day for 6~     months. During this time, every patient will keep track of her period on a calendar.~      Blood tests measuring insulin, substances important for insulin action, cholesterol, and~     glucose (sugar) will be taken before and after the 6 months of medication. A total of 8~     separate visits will be needed to finish the study. At the end of the study, the~     investigators will then compare the number of periods, blood glucose, insulin, and~     cholesterol levels between the patients that took cinnamon and the patients that took~     placebo.~   "
120215|NCT01482416|"~     The aim of this study is to evaluate the vascular effects of estrogens on climacteric women~     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound~     and compare to placebo.~   "
120162|NCT01483105|"~     The proposed study is designed to utilize a self-hypnosis DVD home-training program for~     parents to use with their children to teach self-hypnosis techniques for inducing relaxation~     and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory~     anxiety, distress, and pain during an invasive medical procedure, for example, voiding~     cystourethrography (VCUG). The study will examine the efficacy of this intervention for~     children undergoing VCUG procedures.~   "
120163|NCT01483092|"~     Prebiotics are non-digestible food ingredients that beneficially affect the host by~     selectively stimulating the growth or activity of species in the colon that can improve host~     health.~      Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic~     activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results~     in an increase in bacterial biomass and the production of SCFA (acetate, propionate and~     butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant~     amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat~     (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2~     and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since~     inulin and oligofructose are used by the food industry either as sucrose and fat~     replacements or due to their health benefits for the human host.~      Several human absorption studies evaluated the effect of inulin/oligofructose on mineral~     absorption. It was shown that calcium and magnesium absorption was positively influenced.~     Until now, the positive effect on iron absorption was only shown in animals. The influence~     on human iron absorption was investigated twice. Both studies reported no effect of~     inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived~     study designs.~      The aim of the present study is to demonstrate that inulin consumption over several weeks~     can lead to enhanced iron absorption in humans under optimized conditions.~   "
120164|NCT01483079|"~     Human milk feeding is associated with great benefits to the health and development of~     infants, especially in premature infants. Some mothers are unable or unwilling to provide~     breast milk to their infant. The use of donor human milk products for very low birth weight~     infants as an alternative to cow milk has risen dramatically in the past year.~      Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or~     equal to 1250 grams birth weight receiving an exclusive human milk protein diet.~   "
120165|NCT01483066|"~     The currently held belief is that total knee replacement (TKR) requires the restoration of~     the overall limb alignment to coincide with the mechanical limb axis. To align the knee~     implants with this mechanical axis, rods are used to orient cutting guides with the~     mechanical axis as defined by the center of the femoral head and talus. Standard surgical~     technique typically involves femoral and tibial rods with cutting blocks to facilitate the~     intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the~     method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting~     Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places~     a plastic cutting guide on the end of the femur and tibia, so that cuts that do not~     automatically default to the mechanical axis, but rather attempt to recreate the patient's~     anatomic alignment. The surgeon can then assess implant placement and adjust as necessary~     during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better~     control over the placement of the implants.~      This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary~     TKR in a consecutive series of patients who meet the eligibility criteria. The clinical~     study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.~      One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee~     System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to~     reproduce the natural kinematic alignment of the knee. The other half of the cases will~     receive the Triathlon® CR device in a procedure using traditional instrumentation, without~     navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated~     using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1~     and 2 years postoperatively.~      Primary Hypothesis:~      The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.~      Secondary Hypotheses:~      The investigators expect that ShapeMatch Technology will result in improved clinical~     outcomes relative to usual care at three months postoperatively.~      The investigators expect that ShapeMatch Technology will result in similar clinical outcomes~     relative to usual care at two-years postoperatively.~   "
120166|NCT01483053|"~     There is strong evidence that patients with major depressive disorder (MDD) are at increased~     risk of developing coronary heart disease (CHD). This elevated risk is independent of~     classical risk factors such as smoking, obesity, hypercholesterolemia, diabetes and~     hypertension. The risk of CHD is increased 1½-2 fold in those with minor depression and 3-4½~     fold in subjects with MDD. Put simply, the relative risk of developing CHD is proportional~     to the severity of the depression. While the mechanism of increased cardiac risk~     attributable to MDD is not known disturbances in autonomic function most likely do play a~     part.~      In untreated patients with MDD (with no underlying CHD) the investigators have identified~     that a marked sympathetic nervous activation and diminished heart rate variability (HRV)~     occurs in a proportion (approximately one third) of patients. Diminished HRV has been linked~     to increased incidence rates of acute cardiac events in conditions such as hypertension,~     diabetes and myocardial infarction. Importantly, whether treating depression actually~     improves the risk of: (1) CHD development or (2) recurrence of cardiac events in patients~     with existing CHD remains unknown.~      The investigators, and others, have provided a growing body of evidence linking elevated~     sympathetic activity and exaggerated sympathetic responses to stress to early stages of end~     organ dysfunction and markers of disease development. Of particular note, in addition to~     possible effects on HRV is the association of chronic sympathetic nervous activation to: (a)~     abnormal blood pressure regulation and (b) the development of insulin resistance.~      The investigators therefore plan to examine the cardiovascular effects of two different~     antidepressant medications, agomelatine and escitalopram, in patients with MDD. In addition,~     the investigators plan to investigate the effects these two medications have on sympathetic~     nervous system activity, blood pressure, HRV, endothelial function, metabolic and~     psychological effects.~      Findings from this study will assist us to identify of biological correlates of sympathetic~     nervous activation which will enable us to: (1) identify those at potentially increased~     cardiac risk, and (2) potentially implement additional therapeutic strategies in order to~     reduce cardiac risk. Indeed, it is not known whether antidepressant treatment alone would be~     sufficient to reverse any adverse effects of sympathetic nervous activation. This study aims~     to answer this important clinical question.~   "
120167|NCT01483040|"~     The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a~     video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal~     tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and~     cecum. The device is introduced rectally, as with any standard colonoscope when indications~     consistent with the need for the procedure are observed in the adult patient population.~      The purpose of this prospective clinical study is to establish the usability of the~     PeerScope B System™ when used during standard colonoscopy procedure.~      The study population is comprised of patients indicated for colonoscopy.~      The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary~     endpoints:~        1. The first secondary endpoint is the incidence of complications using the PeerMedical~          colonoscope.~        2. The second secondary endpoint is successful therapeutic interventions as biopsies,~          polypectomies, APC etc.~        3. The third secondary endpoint is the procedure time.~        4. The fourth secondary endpoint is the subjective evaluation of the additional view angle~          by the physician.~        5. The fifth secondary endpoint is patient satisfactory.~   "
120168|NCT01483027|"~     The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal~     cancer with metastases in the liver, who are scheduled to receive second line chemotherapy.~     All patients receive the standard of care chemotherapy with or without the addition of~     TheraSphere.~   "
120170|NCT01483001|"~     Lung Cancer (LC), colorectal cancer (CRC) and breast cancer (BC) are the major killers in~     oncology, accounting for about 40% of cancer deaths. Although progresses have been made in~     the last few years, unfortunately no patient with metastatic disease can obtain a definitive~     cure.~      A recent hypothesis is that cancer is driven by a small subpopulation of cells called~     cancer stem cells (CSCs) or tumor initiating cells with an unlimited proliferative~     potential and the ability to reproduce the original human tumor in experimental animal~     models. These cells are thought to be responsible for the development of the tumor and~     represent the only cell population able to sustain tumor growth and progression.~      Therefore, CSCs represent the elective target for new targeted therapies, endowed with high~     and selective toxicity towards the tumor but harmless towards normal cells.~      Current technologies allow us to isolate and expand in vitro the CSCs from tumor specimens,~     testing their sensitivity to different anticancer drugs in a short period of time.~      Therefore, there is the potential opportunity to identify LC, CRC and BC CSCs.This is a~     prospective study assessing feasibility of CSCS isolation in LC, CRC and BC.~      Patients with a previously performed diagnosis of LC, colon cancer or breast cancer with no~     further standard therapy options, with a Karnofsky performance status of 100% and with tumor~     tissue available will be considered eligible for the study. Tumor tissue will be collected~     before study entry, i.e tissue obtained during a diagnostic or therapeutical procedure, like~     surgery or biopsies with other purposes than the protocol. In vitro tumor sensitivity to~     chemotherapy drugs will be tested on tumor cell cultures per each patient.~      Drugs and their combination will be considered effective and if they kill ≥ 60% of tumor~     stem cells in vitro test. By using cancer spheres the investigators will also generate~     orthotopic xenograft models that recapitulate the parental tumor behaviour, including the~     aggressive features and the invasiveness potential. Orthotopic injection technique will be~     assessed in 5 weeks-old NOD/SCID mice~   "
120171|NCT01482988|"~     The principal aim of this study is to establish if a polymorphism in a gene important for~     innate immunity to fungi represents a significant risk factor for the development of Candida~     colonisation and subsequent invasive candidosis in critically ill patients. Incorporation of~     a screening programme onto a risk-based algorithm for critical care patients would allow~     more effective targeting of molecular diagnostic tests, anti-fungal prophylaxis and targeted~     treatment. Sequential critical care patients will be screened for gene polymorphisms and~     undergo regular screening for Candida colonization.~   "
120172|NCT01482975|"~     The overarching objective of this research is to prevent substance use in early adolescents~     through the use of innovative interactive interventions tailored to each individual's~     particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test~     the effectiveness of the computer-based profile-based tailored interventions to keep early~     adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the~     computer-based profile-based tailored interventions to keep early adolescents from using~     alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet~     and physical activity interventions will be effective in reducing these two high risk~     behaviors as part of the comparison condition.~   "
120173|NCT01482962|"~     This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib~     compared with single-agent treatment, as selected by the investigator from the offered~     options of pralatrexate or gemcitabine or romidepsin, in patients with relapsed or~     refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a~     single-agent comparator in countries that do not permit its use at this time.~   "
120174|NCT01482949|"~     The purpose of this study is to evaluate clinical response to AGS-003 alone or in~     combination with sunitinib therapy.~   "
120175|NCT01482936|"~     This is a single center, open label, randomized, parallel group single dose intravenous~     (i.v.) administration study. The subjects will be randomized to receive a single dose of~     OxyNorm® 2.5, 5, and 10mg.~   "
120176|NCT01482923|"~     A treatment session especially for PLWHA to help them discuss and take action about their~     smoking may be useful.~   "
120177|NCT01482910|"~     This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into~     the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual~     function in Chinese subjects with age-related neovascular or wet age-related macular~     degeneration.~      Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both~     treatment groups will receive the other treatment as a sham procedure.~   "
120178|NCT01482897|"~     The specific aim of this study is to determine whether a medical intervention improve status~     of patients with discal sciatica and if yes which type of intervention.~   "
120179|NCT01482884|"~     The study is designed to evaluate the clinical efficacy and safety of tralokinumab as~     compared to placebo. Investigational product will be administered as subcutaneous injection.~     All patients will continue background therapy for ulcerative colitis as per local standards~     of care in addition to investigational product.~   "
120180|NCT01482871|"~     The objective of this study is to evaluate the safety and efficacy of ophthalmic~     intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The~     primary endpoint of this study is observation of dose limiting toxicity and maximum~     tolerated dose. The secondary endpoint of this study is observation of a clinical effect in~     BCVA (ETDRS letters) and OCT central macular thickness.~   "
120181|NCT01482858|"~     This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder~     (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus~     placebo, primarily as assessed by the Numeric Rating Scale (NRS), and Brief Pain Inventory~     (BPI). It is also intended to evaluate disability change with the Oswestry Low Back Pain~     Disability Index (ODI) and to evaluate whether GASP consumption leads to reduction in~     analgesic standard of care (ASOC) versus placebo, using weekly analgesic consumption~     diaries.~   "
120182|NCT01482845|"~     This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20~     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's~     disease on stable doses of acetylcholinesterase inhibitors.~   "
120183|NCT01482832|"~     The Specific Aim of this proposal is to conduct a randomized controlled trial to evaluate~     whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a~     didactic attention-control program reduces the risk of PPD in adolescent mothers.~      Primary Hypothesis:~        1. The intervention (Project REACH) will be significantly more efficacious than the~          control program in reducing the risk of PPD up to six months postpartum in adolescent~          mothers.~           Secondary Hypotheses:~        2. The decreased rate of major depression in the Project REACH group compared to the~          control program group will be sustained through one year postpartum.~        3. Adolescent mothers in Project REACH compared to the control program group will have~          higher levels of maternal-child bonding.~   "
120184|NCT01482819|"~     The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial~     bleb response to wearing galyfilcon A lenses in asian eyes.~   "
120185|NCT01482806|"~     Depression and anxiety are common in primary care practice and are associated with~     substantial reductions in health-related quality of life. This Project will test the~     comparative effectiveness of two on-line treatments for these conditions provided through~     the context of a Collaborative Care program: (1) moderated access to a proven-effective~     computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to~     CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the~     effectiveness of these treatments to PCPs' usual care for these conditions, and evaluate~     the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial~     to provide a greater understanding of how to best scale the delivery of these interventions~     into a variety of primary care settings.~   "
120186|NCT01482793|"~     The objective of this study is to gather data regarding the efficacy, safety and~     cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures~     less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all~     vertebroplasties.~      The primary effectiveness analysis will be based on the number of patients whose numeric~     rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks~     post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly~     larger proportion of patients achieving pain reduction than the control group. A secondary~     analysis will compare the change in mean pain scores and specific activity related pain~     scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary~     effectiveness analysis will include the mean change in the back-pain specific limitation in~     function as quantified by the Roland Scale at these same data collection time points.~   "
120187|NCT01482780|"~     The aim of the study is to analyze the potential of pressure controlled intermittent~     coronary sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as~     reperfusion injury. To achieve insight into the clinical significance of this local~     preconditioning effect, global hemodynamics, cardiac performance and clinical outcome in the~     first 30 days will be related to the ability of this intervention to protect the myocardium~     in elective surgical procedures, ameliorating cellular decay and preserving the~     microcirculation therefore improving graft flow, reducing enzyme leakage and finally~     improving myocardial performance.~   "
120188|NCT01482767|"~     Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with~     HIV-1. At the time the study was designed, the standard treatment for people with HIV-1 and~     HCV coinfection included two drugs: pegylated-interferon alfa 2b (PEG-IFN) and ribavirin~     (RBV). The purpose of this study was to evaluate the effectiveness of giving boceprevir~     (BOC) together with standard treatment in treating HCV infection in people with HIV-1 and~     HCV coinfection.~   "
120189|NCT01482754|"~     This is an observational prospective cohort study design to evaluate the safety of rapid~     Rituximab infusion at 90 minutes for Non-Hodgkin Lymphoma (NHL) patients. The secondary aim~     is to measure the number of rejected chemotherapy administration on schedule. Non-Hodgkin~     lymphoma patients who tolerated well for at least 2 cycles of standard infusion of Rituximab~     without grade 3 or 4 adverse events will be recruited in the study. In this study, the first~     20% of the total dose of rituximab will be administered over 30 minutes. When subjects~     tolerate the infusion and stable vital signs, the remaining 80% of the total dose will be~     administered over 60 minutes. Prior administration of Rituximab, premedication will be given~     to the subjects including PO Paracetamol 1g, IV Diphenhydramine 25/50mg and/or IV~     Hydrocortisone 100mg. The duration of subjects involvement in the study approximately takes~     72 hours. Adverse events that occur within the first 24 hours of infusion will be evaluated~     if related to Rituximab infusion as some subjects are receiving combination chemotherapy~     with rituximab. This study will recruit both in patients and out-patients. A phone call to~     monitor subject's health will be made post 24, 48, 72 hours of rituximab infusion. The~     findings from this study will add evidence to the safety of rapid Rituximab infusion at 90~     minutes. If the outcome is favourable, NUH will consider adopting the new infusion rate for~     Rituximab infusion for patients who tolerated at least 2 cycles of standard infusion~     recommended by the drug manufacturer.~      The study hypothesizes that rapid Rituximab infusion at 90 minutes is safe for NHL patients.~   "
120190|NCT01482741|"~     Risks from imaging-related radiation exposure have become a popular topic in the media.~     Because these tests are commonly applied to patients at a cancer center, it is important to~     understand what patients know, how they feel about what they know, where they get their~     information, and how satisfied they are with available risk-benefit communication on this~     topic.~      The purpose of this study is to understand how cancer patients perceive risks and benefits~     of diagnostic radiation and their satisfaction with healthcare communication on this topic.~   "
120191|NCT01482728|"~     The purpose of this study is to see if the investigators can measure inhibition of a~     protein, Src (named for Sarcoma), in tissue and blood in patients with a diagnosis of~     endometrial cancer. Dasatinib is a drug that blocks the activity of an important protein in~     cancer cells called Src. The investigators can measure the blocking of Src in the~     bloodstream. However, the investigators do not know if measures in the bloodstream reflect~     blockage of Src in cancer tissue. The investigators are doing this study to try and see if~     the investigators can match what the investigators see in cancer tissue to what the~     investigators see in the bloodstream. the investigators hope that in the future, the~     investigators can use blood to measure protein inhibition by dasatinib instead of asking~     patients to undergo repeat biopsies.~   "
120192|NCT01482715|"~     Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate~     the safety of different doses and dosing regimens of oral rucaparib administered daily to~     patients with solid tumors.~      Part 2A (Completed Enrollment) and Part 2B (Currently Enrolling) - The purpose of the second~     part of the study is to determine the safety and clinical activity of the RP2D of oral~     rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or~     somatic).~      Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further~     evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid~     tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).~   "
120216|NCT01482403|"~     This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will~     evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in~     combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C~     infection. The anticipated time on study treatment is up to 48 weeks.~   "
120193|NCT01482702|"~     Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese.~     The American Cancer Society has called for weight loss treatment to be standard of care for~     overweight women with breast cancer. During therapy women with breast cancer often gain~     weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have~     their cancer come back. The reason why overweight breast cancer survivors are more likely to~     re-occur has not been well studied, but changes in how insulin works may contribute.~     Overweight survivors are also at risk for the other chronic diseases associated with~     obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve~     risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered~     via the internet has been developed at the University of Vermont. This successful~     intervention has not been tested among breast cancer survivors. Given that women tend to~     lose muscle mass during cancer therapy the addition of a resistance training component to~     the weight loss intervention may be important. Therefore the overall goal of this project is~     to pilot test a proven distantly- delivered behavioral weight loss intervention among~     overweight breast cancer survivors and to evaluate whether a resistance program results in~     improvements in lean body mass, while studying how both interventions change insulin~     sensitivity.~      Specifically, this project is a randomized, controlled clinical trial designed to test the~     effectiveness and acceptability of a 6-month behavioral weight loss intervention with and~     without resistance training. Participants will be randomized to one of two groups: 1)~     behavioral weight control treatment via the Internet; or 2) behavioral weight control~     treatment via the Internet plus a resistance training program. Women eligible to participate~     include overweight breast cancer survivors who are age 50 or older and 6-36 months past~     receiving chemotherapy. Assessments will be conducted at baseline and six months and will~     include measures of body weight, muscle mass, adherence to treatment, and insulin~     sensitivity.~   "
120194|NCT01482689|"~     The main aim of the present study is to compare the bioavailability of vitamin D from cod~     liver oil and multivitamin tablets given to healthy individuals under the same conditions,~     as well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy~     subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per~     day of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively.~     Serum samples will be drawn at baseline and after four weeks (28 days) for the analysis of~     25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant~     acid phosphatase in serum.~   "
120195|NCT01482676|"~     Urgency, frequency and incomplete emptying are the key symptoms of lower urinary tract~     dysfunction, including bladder pain syndrome/interstitial cystitis, and overactive bladder~     syndrome. Lower urinary tract dysfunction is associated with cellular stress, leading to~     changes in gene expression and consequent organ remodeling. MicroRNAs are small regulatory~     molecules, affecting protein synthesis. They are quickly winning recognition as potential~     therapeutic agents. The investigators will perform a comparative study of mRNAs changed in~     lower urinary tract dysfunction and address the role of differentially expressed miRNAs in~     regulation of the genes, important for bladder function. The experimental approach,~     combining the analysis of human biopsy material with the in vitro cell-based models, will~     allow the investigators to elucidate the effects of miRNAs on the expression of receptors,~     contractile proteins and tight junction proteins. Once the disease-induced miRNAs have been~     characterised and their target genes validated, it will be possible to influence their~     expression levels thus counter-acting their effects.~      The investigators' work addresses fundamental mechanisms of signal transduction in~     urothelium and smooth muscle during cellular stress caused by inflammation or bladder outlet~     obstruction, and its regulation in the diseased state. The investigators' findings will~     further the knowledge of the molecular mechanisms of lower urinary tract dysfunction and~     have implications for diagnosis and treatment. Additionally, they have relevance for other~     clinical conditions, where miRNAs are implicated.~   "
120196|NCT01482663|"~     Hand eczema is a common disease which often gives a chronic course thus affecting many~     functions in daily life. The body of evidence related to self-management of chronic hand~     eczema is poor. Better methods to support self-management of patients with chronic hand~     eczema may potentially improve the prognosis of a disease which is both a tremendous burden~     to the individual and to the society. The purpose of this trial is to evaluate the effect of~     a newly designed guidance programme offering individual counselling compared to conventional~     information with written information sheets.~   "
120197|NCT01482650|"~     The investigators have performed a number of studies on novel airway devices, including an~     observational study on the performance of a new supraglottic airway named Baska mask. In~     this new proposed study the investigators would like to compare directly,in a randomized~     clinical trial, this device with the device the investigators routinely use - the single use~     laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.~      This study will determine which device performs best, as measured by key parameters~     (insertion success rate, seal pressures, time to and ease of insertion, failure rate,~     complications etc) as regarding the performance and safety profile of the Baska mask and the~     LMA.~      The investigators have two study hypotheses, namely (1) non-inferiority of first placement~     attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs~     LMA.~      A number of secondary endpoints will be monitored and analyzed (time to and ease of~     insertion, failure rate, complications etc).~   "
120198|NCT01482637|"~     In this study, the investigators seek to further develop the CAS as a comprehensive,~     reliable, and valid instrument for measuring coercion to participate in research among adult~     substance abusing offender populations.~   "
120199|NCT01482624|"~     The primary objective of this clinical investigation is to determine whether~     post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can~     relief pain, improve mobility and promote joint recovery, compared to the standard~     arthroscopy procedure alone, in patients undergoing arthroscopic procedure.~   "
120200|NCT01482611|"~     The purpose of this study is to investigate the safety, tolerability and plasma~     pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food)~     from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a~     JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever~     comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is~     600 mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the~     plasma pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy~     Caucasian participants will be studied. JNJ-47910382 is a drug that is being developed to~     treat Hepatitis C infection and is an inhibitor of the reproduction machinery of the~     Hepatitis C virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the~     bloodstream, distributed in the body and eliminated from the body.~   "
120201|NCT01482598|"~     The Study Purpose is to demonstrate the superiority of optimized remote patient management~     compared to optimized standard care in the management and prognosis of heart failure, in the~     prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the~     reduction of inappropriate shock therapies. The remote care allows early intervention in~     terms of drug therapy adjustment and cardiac resynchronization therapy (CRT‐D) device~     reprogramming.~   "
120202|NCT01482585|"~     to determine the values of imaging and genetic biomarkers for prediction of tumor~     aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify~     unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate~     the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a~     guideline for planning an appropriate follow-up examination and management~   "
120203|NCT01482572|"~     The purpose of this study is to evaluate the feasibility of aspiration samples for~     mutational analysis in patients with a non-small cell lung cancer (NSCLC).~   "
120204|NCT01482559|"~     The HIP trial is a large pragmatic, multinational, randomised trial of two different~     strategies for the management of hypotension in extremely low gestational age newborns~     (Standard with dopamine versus a restricted with placebo approach).~      HYPOTHESIS: A restricted approach to the management of hypotension in extremely low~     gestational age newborns will result in improved neonatal and long-term developmental~     outcomes.~      PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of~     hypotension compared to using dopamine as first line pressor agent in infants born less than~     28 weeks of gestation within the first 72 hrs after birth (transitional period), improves~     survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves~     survival without moderate or severe neurodevelopmental disability at 2 years corrected age.~   "
120205|NCT01482546|"~     Hypothesis: Novice trainees will achieve significantly higher clinical competence and~     patient satisfaction scores with the use of warm water infusion method when compared with~     traditional air insufflation~      Primary outcome: adenoma detection rate~      Secondary outcomes: (1) independent cecal intubation rate, (2) trainer assessment of~     trainee's colonoscopy skills, (3) trainee's assessment of clinical confidence, (4)~     procedural medication requirement, (5) patient pain level during procedure, (6) patient~     satisfaction at procedure completion, and (7) patient willingness to repeat procedure'~      Specific Aim: To demonstrate the stated hypothesis via above outcome measures. The long term~     goal is to provide evidence to influence other training institutions to consider education~     in the warm water infusion method'~   "
120206|NCT01482533|"~     The main purpose of this study is to compare the effectiveness and accuracy of tissue~     cultures and swab cultures to diagnose prosthetic joint infection.~   "
120207|NCT01482520|"~     All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular~     targeted therapy will be candidates for the study.~      No additional treatment or intervention will be conducted except for blood sampling that~     will be limited to one time only.~      Blood samples (10 cc in volume) will be collected from all study participants once they~     provided written informed consent form. DNA will be extracted from peripheral blood samples~     using DNA isolation kit.~   "
120208|NCT01482507|"~     Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone~     oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid~     Arthritis (RA).~   "
120209|NCT01482494|"~     The adult onset form can occur between the second and sixth decades of life as a form of~     proximal myopathy, predominantly in the pelvic girdle area. Sometimes the first symptoms are~     shortness of breath and diaphragm weakness which herald progressive proximal muscle~     weakness. The heart and liver are not affected.~      Serum CK (Creatine Kinase) activity is 2 to 10 times higher than normal. EMG~     (electromyogram) testing usually reveals a myopathic pattern and muscle biopsy may show~     vacuoles containing an accumulation of glycogen that is not broken down.~      Until fairly recently, an assay of acid maltase activity using cultured fibroblasts after~     biopsy of skin or muscle tissue was required for diagnosis, as leukocytes contain a renal~     isoenzyme that is not absent in these patients and which can mask the deficit and result in~     false negatives. In recent years this problem has ben solved by the introduction of~     acarbose, an inhibitor of renal α-glucosidase; it is also used in the dried blood spot~     method, which measures acid maltase activity using maltose and acarbose as inhibitors and~     4-methylumbelliferyl-D-glucopyranoside as substrate.~   "
120210|NCT01482481|"~     Background: Nurses in clinical practice implement care to patients with Type 2 diabetes~     mellitus (DM2) in order to maintain normal blood glucose readings, promote weight loss and~     provide nutrition counseling to improve metabolic and blood pressure control. Because many~     disciplines contribute to patient's health outcomes, it is important to distinguish how~     nurses contribute to patient care and the achievement of health outcomes and the differences~     between the use or not the classification of Nursing Diagnoses, and the Nursing~     Interventions Classification (NIC) in clinical practice settings.~      Methods: Prospective observational study with 2-year follow-up to assess the effect of~     Nursing Care Plans based on Scientific Methodology (NCPSM) on changing the control~     parameters in routine clinical practice conditions.~      Settings: 31 Primary care centers in northeastern urban area of Madrid (Spain). Subjects:~     24,124 DM2 patients (full universe).~   "
120211|NCT01482468|"~     The purpose of this study is to determine whether continuous infusion of palonosetron after~     its prophylactic single injection can further reduce the incidence of postoperative nausea~     and vomiting in patients undergoing gynecological laparoscopic surgery.~   "
120212|NCT01482455|"~     There is a current debate whether impaired insulin-mediated microvascular perfusion limits~     the delivery of hormones and nutrients to muscle and whether short term FFA elevation~     affects transcapillary transport of insulin and glucose thereby representing a~     rate-controlling step for insulin-stimulated muscular glucose disposal in humans.~      To address these questions, the investigators determined the changes of interstitial glucose~     and insulin in skeletal muscle of healthy volunteers during intravenous administration of~     triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic~     conditions.~   "
120213|NCT01482442|"~     The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium~     microspheres is more effective on overall survival in advanced Hepatocellular carcinoma~     (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib~     which is now the standard treatment of advanced HCC.~   "
120214|NCT01482429|"~     Prolongation of mechanical ventilation poses serious personal and financial threats to~     healthcare consumers.~      The investigators objectives are create and implement an multidisciplinary evidenced-based~     ventilator-weaning protocol to assess whether a systematic approach compared with the~     physician's judgment only decreases time spent on the ventilator, complications of~     mechanical ventilation and length of stay in critical care unit.~   "
120217|NCT01482390|"~     This randomized, double-blind, multi-center, parallel-group study will evaluate the~     sustained virologic response and the safety of mericitabine (RO5024048) in combination with~     telaprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The~     anticipated time on study treatment is up to 48 weeks.~   "
120218|NCT01482377|"~     This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety,~     pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or~     erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive~     solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599~     as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in~     Part C) followed by an extension phase for each part.~      In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled~     RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo~     biodistribution and organ pharmacokinetics of RO5479599.~   "
120219|NCT01482364|"~     The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then~     applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management -~     IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure~     monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e.~     without IHM) during a 6 months intensive treatment program.~   "
120220|NCT01482351|"~     The goal of the research is to determine the power and the feasibility of the study design~     and methods to inform a full-scale clinical trial that will determine whether treatment of~     obstructive sleep apnea in older adults with mild cognitive impairment delays cognitive~     decline and preserves everyday function.~   "
120221|NCT01482338|"~     The purpose of this study is to determine whether low-dose combine oral contraceptives (COC)~     containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of~     Premenstrual symptoms.~   "
120222|NCT01482325|"~     The primary objective of this study is to show that the noninvasive blood pressure software~     algorithm meets engineering requirements.~   "
120223|NCT01482312|"~     The purpose of this study is to evaluate two different types of contact lenses and their~     effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.~   "
120224|NCT01482299|"~     This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month~     progression-free survival rate (primary end-point) and response rate, toxicity, overall~     survival and biomarker assessment (secondary end-points) in patients with metastatic or~     recurrent gastric cancer with pS6 Ser 240/4 expression.~      Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach~     with measurable disease who failed previous first-line palliative chemotherapy including~     fluoropyrimidine and platinum with high expression of pS6 Ser 240/4.~      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted~     according to the observed clinical toxicities. Treatment will be continued until disease~     progression or patient's intolerability to the study drug.~      A study requires 40 assessable subjects to decide whether the proportion of patients who are~     free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater~     than or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of~     responses is 7 or less, the hypothesis that P >= 0.250 is rejected with a target error rate~     of 0.200 and an actual error rate of 0.182. If the investigators assume that drop-out rate~     is 10%, total accrual patient will be 45.~   "
120225|NCT01482286|"~     Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of~     reproductive age and despite decades of research the etiology the disorder is not known. The~     characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine~     function and insulin resistance. Obesity is a common correlated phenotype of Polycystic~     ovary syndrome and weight gain worsens the reproductive and metabolic complications.~     Currently there is no evidence-based treatment plan for infertility in Polycystic ovary~     syndrome; yet weight loss by dietary restriction and regular exercise are strongly~     advocated. Weight loss and increased insulin sensitivity appear to drive improvements in~     reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism~     connecting these changes with the reproductive axis is not fully understood.~   "
120226|NCT01482273|"~     Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for~     developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to~     more distal DVT. There's evidence that the early removal of the obstructing thrombus by~     catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher~     degree of thrombolysis is associated with lower incidence of PTS, better quality of life and~     lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced~     thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency,~     low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic~     drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis,~     however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been~     formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced~     thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with~     symptomatic ilio-femoral DVT.~   "
120227|NCT01482260|"~     Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous~     malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression~     profiling using microarrays.~   "
120228|NCT01482247|"~     The purpose of the study is to employ the supplement L-arginine to test the hypothesis that~     activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in~     older subjects with diabetes mellitus and/or hypertension (high blood pressure).~   "
120229|NCT01482234|"~     The purpose of this study is to assess whether text messages can be used as a way to~     increase the amount of physical activity teens get each day.~   "
120230|NCT01482221|"~     The purpose of this study is to assess the effect and safety of AZD6765 in patients with~     major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a~     channel blocker of the NMDA class of glutamate receptors.~   "
120386|NCT01480180|"~     This trial is conducted globally. The aim of the trial is to evaluate the safety and~     efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC~     0129-0000-1003 (N8-GP) in subjects with Haemophilia A.~   "
120231|NCT01482208|"~     Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration~     status in newborns and infants by means of ultrasound velocity measurements through muscle~     tissues. Changes of tissue hydration will be followed during first days of life in newborns~     and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical~     dehydration symptoms will be used as controls.~   "
120232|NCT01482195|"~     A recombinant adeno-associated virus serotype 2 (rAAV2) vector has been altered to carry the~     human MERTK (hMERTK) gene. This vector has been shown to restore vision in animal models~     that resemble human MERTK-associated Retinitis Pigmentosa (RP), an incurable retinal~     degeneration that causes severe vision loss. The proposed study is an open label, Phase I~     clinical trial of subretinal rAAV2-VMD2-hMERTK administration to individuals with~     MERTK-associated retinal disease. This trial will lead to a greater understanding of the~     safety and thereby potential value of gene transfer in MERTK-associated retinal disease and~     will have implications for other forms of retinal degenerative disease amenable to this type~     of intervention.~   "
120233|NCT01482182|"~     In this prospective study, the investigators will evaluate and compare the usefulness of~     functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the~     palliative chemotherapy with the aim of predicting tumor response and prognosis in patients~     with advanced Non-small Cell Lung Cancer (NSCLC).~   "
120234|NCT01482169|"~     The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to~     intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.~   "
120235|NCT01482156|"~     Study has two parts:~        1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety~          and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in~          patients with advanced solid tumors.~        2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in~          patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer~   "
120236|NCT01482143|"~     The aim of this study is to characterize the pharmacokinetics and safety/tolerability of~     AFQ056 in children with Fragile X Syndrome(FXS)~   "
120237|NCT01482130|"~     The current guidelines emphasize the prevention of bone loss, by building up bone mass in~     young age, as one of the most important measures to reduce the incidence of osteoporosis.~     Strength training and explosive exercises have been shown to have beneficial effects on~     bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis~     concludes that it is still unclear what type of exercises, intensity and execution that is~     most effective for skeletal adaptations. The following study will examine the effect of 12~     weeks of heavy, explosive strength training on bone mineral density and bone metabolism in~     young, healthy girls aged 18-30 years.~   "
120238|NCT01482117|"~     The aim of this study is to investigate the effects of genetic polymorphisms on~     pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean~     healthy adult volunteers.~   "
120239|NCT01482104|"~     Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a~     slow-growing tumour which despite low metastatic potential may cause significant local~     tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic~     therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1~     week apart. This procedure is considered quite time- and resource-consuming. Introducing a~     single treatment session, with a new PDT session for treatment failures after 3 months,~     might represent an attractive simplification.~      This randomised controlled single-blinded multi-centre study primarily aims to compare BCC~     lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with~     re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2~     standard Metvix(R) PDT treatments 1 week apart.~      Secondary objectives are to investigate the treatment response in relation to clinical and~     histological tumour characteristics such as tumour thickness, subtype and~     immunohistochemical markers.~   "
120240|NCT01482091|"~     The purpose of this study is to determine if intranasal fentanyl can decrease the pain of~     patients with sickle cell disease who present to the pediatric emergency department with a~     vaso-occlusive crisis.~   "
120241|NCT01482078|"~     Magnesium is a treatment for mothers to protect brains of babies born early. This study~     investigates combined effects of magnesium and spinal or epidural anesthesia on mothers~     having cesareans.~      The investigators will use a scoring system to measure sedation and devices that subjects~     breath in and out of to measure breathing strength.~      The investigators hypothesize the combination of magnesium and anesthesia will reduce~     breathing strength and cause sedation.~      This is an observational study comparing those having magnesium and anesthesia with those~     just having anesthesia. Routine medical care will not be altered.~      Results will hopefully allow anesthesiologists to provide better patient care.~   "
120242|NCT01482065|"~     This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in~     patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is~     related to the severity of NAFLD, and 3) whether treatment of OSA with continuous positive~     airway pressure (CPAP) improved NAFLD progression.~      OSA is a condition caused by repetitive collapse of throat tissue during sleep that leads to~     falls in oxygen level and sleep disruption. OSA can be caused by obesity, and especially by~     fat found in the neck and belly.~      NAFLD is a common disease linked to obesity. NAFLD is part of a disease spectrum, which can~     progress from steatosis (fatty liver) to nonalcoholic steatohepatitis (NASH), a progressive~     fibrotic disease, in which cirrhosis and liver-related death can occur. Recent evidence in~     patients with obstructive sleep apnea (OSA) indicates that OSA is associated with NASH. How~     common OSA is in patients with biopsy-confirmed NAFLD and the effect of OSA treatment with~     CPAP on NASH is unknown.~   "
120243|NCT01482052|"~     The purpose of this study is to evaluate the safety of a new conjugate vaccine,~     NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal~     A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of~     antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine,~     as a measure of vaccine effectiveness.~   "
120458|NCT01479231|"~     The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in~     Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to~     Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the~     effect of GERD on the location of esophageal eosinophilia.~   "
120244|NCT01482039|"~     The investigators propose a prospective evaluation of methods to assess cervical length for~     uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for~     routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach~     to screening of the cervix (which consists of initial transabdominal evaluation first with~     transvaginal ultrasound reserved only for those patients in whom the cervix appears short on~     transabdominal exam or when adequate views cannot be obtained with the transabdominal~     approach alone) will take less time, will result in the same number of adequate views of the~     cervix and will have higher patient satisfaction that a universal transvaginal screening~     approach.~      OBJECTIVE~      To determine the best strategy for cervical length screening in uncomplicated singleton~     gestations between the gestational ages of 18-28 weeks.~      Primary outcome:~      1) Time required to obtain adequate views of the cervical length.~      Secondary outcomes:~        1. Patient satisfaction with ultrasound experience as measured by patient questionnaire~        2. Number of adequate views of the cervix obtained with each approach~      STUDY DESIGN~      This is a prospective study to compare strategies for cervical length measurements in~     uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal~     well being ultrasound between 18-28 weeks gestation. The different strategies include 1)~     Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the~     cervical length (transabdominal followed by transvaginal if necessary due to short cervix or~     inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients~     with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound~     between 18-28 weeks will be randomized into one of the three groups noted above after~     consent is obtained. Ultrasound examination will then take place and data collected. The~     various strategies listed above will be compared for the following:~        1. Time required to obtain views of the cervix~             1. Time from initiation of exam to completion of cervical assessment~             2. Time for completion of entire exam~        2. Patient satisfaction~             1. Comfort/Discomfort of exam procedure~             2. Overall impression of exam process~        3. Number of adequate views of the cervix obtained~      Maternal demographics including age, parity, weight, height and due date/gestational age~     will also be obtained for all consenting patients.~   "
120245|NCT01482026|"~     The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients.~     Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for~     one of the most important in terms of frequency and psychosocial and educational~     consequences.~      In these conditions, our study was designed to estimate the sensitivity to changes of the~     different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This~     will then optimize our methodological approach for a therapeutic trial.~   "
120246|NCT01482013|"~     This is a safety and tolerability study investigating the effect of HPP854 in subjects with~     mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess~     the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic~     relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.~   "
120247|NCT01482000|"~     The purpose of this study is to compare the exercise capacity and pulmonary function test~     parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care~     with and without pulmonary daoyin therapy of China in community.~   "
120248|NCT01481987|"~     Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral~     Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane~     (ERM).~      Design: Cross sectional case-control series.~      Methods:~      Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic~     ERM and twenty-seven healthy patients (27 eyes) as a control group.~      Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography~     (SD-OCT).~   "
120249|NCT01481974|"~     The overall purpose of this study is to evaluate the safety, pharmacokinetics and~     preliminary efficacy of a five-days post-operative course of Treprostinil in liver~     transplant patients.~      The hypothesis of this study is that Treprostinil can be safely administered~     post-operatively in liver transplant patients. Once safety is documented future studies will~     address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver~     graft and thereby reduce morbidity, leading to shorter hospital stays as compared to~     historical controls.~   "
120250|NCT01481961|"~     The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS)~     applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early~     Alzheimer's disease (AD).~      This study included 15 patients treated with rTMS and whose medication reference is~     stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected~     in the MCRR of Besançon and the psychiatric department of the University Hospital of~     Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using~     the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS),~     State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety~     Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized~     by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued~     Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test~     (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96),~     Rey-complex figure test-copy and Picture naming 80 items test (DO80).~      Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25~     seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A~     psychometric assessment will be conducted again at the end of treatment week and one month~     after stopping treatment. A neuropsychometric assessment will be conducted one month after~     stopping the treatment. Scales of comfort and acceptability will also be proposed to the~     patient to determine whether any gene is caused by this treatment. Moreover a questionnaire~     will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and~     4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy~     Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily~     Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of~     recent change of the personality (CP6).~      The population of this study will be comprised of patients between 60 to 85 years-old with~     early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be~     recruited on a voluntary basis, after notification and consent in the research center. This~     study was conducted over a period of 15 months.~   "
120251|NCT01481948|"~     The purpose of this project is to reduce health disparities in obesity risk among 8-10 year~     old African American girls using a culturally sensitive and developmentally appropriate~     internet-based program with no face-to-face interaction. This study will conduct an outcome~     evaluation to test short and longer term effects on obesity risk.~   "
120252|NCT01481935|"~     The purpose of this study is to determine whether extra cleaning of frequently-contaminated~     surfaces in intensive care rooms is effective in preventing contamination of disposable~     isolation gowns and gloves with multi-drug resistant bacteria.~   "
120253|NCT01481922|"~     This study is intended to help guide the choice of needle diameter when performing a lumbar~     puncture.~      Smaller spinal needles have been shown to decrease rate of adverse events such as~     post-lumbar puncture headache and hearing loss.~      The main drawback to using smaller needles is diminished flow rate; some textbooks recommend~     using needles no smaller than 22 gauge because of the slow flow rate though others recommend~     smaller needles, namely 22-24 gauge.~      Some authors have described a successful use of spinal needles as small as 25 gauge when~     performing a lumbar puncture.~      The investigators do not believe that the flow-rate difference between 22 and 24 gauge~     needles is significant enough to justify using the larger needles.~      The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for~     flow rate, and incidence of the known complications of pain during procedure and backache at~     8 and 15 days post-procedure.~      The investigators will also look at whether smaller needles are associated with less pain~     during the procedure and less backache the next 2 weeks after the procedure.~   "
120254|NCT01481909|"~     Study title:~      An exploratory, randomised, double-blind, placebo controlled crossover study to assess the~     efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.~      Study code:~      SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to §~     40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,~     Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,~     D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical~     Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin~     Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin~     Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II~      Primary objective:~      Reduction of wheal and flare type skin reaction after standardised provocation testing~     assessed by volumetric and thermographic measurements.~      Secondary objectives:~      Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as~     assessed by symptom score, DLQI, Itchy-QoL and VAS.~      Study design:~      An exploratory, randomised, double-blind, placebo controlled crossover study~      Type and number of patients:~      Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic~     mastocytosis with skin involvement~      Main criteria for inclusion:~      Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid~     or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode~     of administration 20 mg Rupatadine or placebo before provocation testing, oral~     administration (tablets)~      Duration of treatment:~      28 days (testing will be done at the day of last treatment)~      Assessment of efficacy:~        1. Assessment of wheal and flare development by planimetric analyses of digital~          photographic, volumetric, and thermographic imaging (time lapse) before and after~          treatment with study medication,~        2. Additional assessment of symptoms,~        3. Assessment of life quality~      Main criteria of evaluation:~      Efficacy~   "
120255|NCT01481896|"~     This retrospective study will review the Anderson Orthopaedic Institute's initial experience~     among a consecutive series of 126 patients who had primary total hip arthroplasty using a~     metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled~     with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels,~     cup orientation, osteolysis, radiographic implant stability and clinical outcome measures~     including component revision, complications, patient satisfaction and Harris Hip Scores will~     be evaluated.~   "
120256|NCT01481883|"~     The aim of this project is to investigate the effect of Raloxifene 120mg in men with~     schizophrenia. This trial will adopt a 12 week randomised controlled model.~      Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators~     (SERM) will have a significantly greater reduction in psychosis symptoms over the course of~     the study than men receiving adjunctive placebo.~      Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater~     improvement in cognitive function than men receiving adjunctive placebo~   "
120257|NCT01481870|"~     The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with~     cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to~     improve progression free survival and overall survival in a comparative study with~     interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching~     to sorafenib is one of the treatment options after disease progression. Reversely, when~     sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line~     therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong~     survival. In this study, sunitinib or sorafenib will be administered as first-line~     molecular-targeted therapy and treatment switched to the other test drug, sorafenib or~     sunitinib, when disease progression is detected to assess which treatment sequence produces~     longer progression free survival and offers a better safety profile (causing fewer adverse~     events). The purpose of this trial is to compare progression free survival of first line~     sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by~     sorafenib versus sorafenib followed by sunitinib.~   "
120258|NCT01481857|"~     Proprioceptive training has been shown to be effective in increasing the efficiency of~     motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that~     proprioceptive support do influence in the activation of the transversus abdominis muscle~     (TrA) during segmental stabilization training.~   "
120259|NCT01481844|"~     The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI~     + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and~     tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole +~     tetracycline ) as second line treatment of H. pylori .~   "
120260|NCT01481831|"~     This purpose of this study is to evaluate the efficacy and safety of single and repeated~     doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and~     highly emetogenic chemotherapy in patients.~   "
120261|NCT01481818|"~     Radiodermatitis and radiation mucositis were the most frequent side-effect during the course~     of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen~     species formed upon radiation therapy play a central role in initiating and driving the~     detrimental signaling events, antioxidant supplementation is thought to provide a~     photoprotective effect against radiation. Green tea extract has been shown to have~     antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety~     and efficiency of green tea extract in the treatment of radio dermatitis and radiation~     mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer~     patients receiving radiotherapy or concurrent chemoradiotherapy .~   "
120262|NCT01481805|"~     To explore biomarkers predictive of clinical response to sorafenib in unresectable~     hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation~     status of receptor tyrosine kinases in signal transduction pathways in FNA samples and~     circulating tumor cells.~      To identify negative predictive markers to sorafenib. To elucidate signal transduction~     pathway attributable to sorafenib resistance. To monitor changes in the RTK activation~     status during sorafenib treatment using circulating tumor cells.~      To analyze correlation between the quantity of circulating tumor cells and circulating~     endothelial cell precursors and treatment response to sorafenib.~   "
120263|NCT01481792|"~     Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser~     for lamellar resection (ReLEx smile) in the reduction of myopia.~   "
120264|NCT01481779|"~     The purpose of this study is:~        -  To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of~          treatment.~        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin~          glargine during 78 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood sugar targets without~          low blood sugar episodes at night to those taking insulin glargine after 78 weeks of~          treatment.~        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin~          glargine after 78 weeks of treatment.~   "
120459|NCT01479218|"~     The objective of the study is to investigate the safety, efficacy and clinical utility of~     the Occlutech PDA device for closure of patent ductus arteriosus of all types.~   "
120265|NCT01481766|"~     The pre-school years are critical years for children to acquire early learning skills such~     as language, fine motor and social skills; this is termed early child development. Primary~     care doctors (family doctors and pediatricians) are in a unique position to identify~     children with health or developmental problems. Screening is the process of testing healthy~     people for the earliest signs of health problems, followed by treatment, with the~     expectation that screening will improve the health of those screened. The focus of this~     research is screening young children for the earliest signs of iron deficiency (low blood~     iron levels) followed by treatment with oral iron.~      Previous research has shown that children with later stages of iron deficiency have serious~     delays in their development. Some research has shown that these delays may persist into~     young adulthood often with a significant reduction in intelligence. Early stages of iron~     deficiency may be difficult for parents or doctors to detect, and a blood test is usually~     needed. However, Canadian guidelines do not recommend screening all children for iron~     deficiency, because there is not enough good quality research to prove that screening is~     effective.~      In this study, the investigators will ask parents to allow their child between the ages of 1~     to 3 years to have a blood test for iron levels. If the blood level is low, the child will~     be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling,~     or a placebo liquid plus diet counseling. A psychologist will measure each child's early~     learning ability before and after the treatment. If this approach to screening children's~     blood iron levels followed by treatment improves children's development, parents and doctors~     may consider that routine blood screening tests are justified. Overall, this research is an~     important step to improving the ways in which primary care doctors can ensure that children~     have the best start to life-long health and achievement.~   "
120266|NCT01481753|"~     The investigators plan to perform a prospective randomized, head-to-head trial to test the~     hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy~     (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or~     Delayed Gastric Emptying (DGE).~   "
120267|NCT01481740|"~     Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35).~     This subgroup of patients represents a large portion of the obstetric patient population~     locally and nationally. It is unclear whether previous research should be extrapolated to~     the obese patient population. This study is being done to compare the incidence of~     hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese~     patients who receive a prophylactic phenylephrine infusion versus those who receive~     phenylephrine boluses for the treatment of established hypotension. This study will help us~     determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to~     prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.~   "
120268|NCT01481727|"~     The purpose of this study is to evaluate the efficacy of high-intensity non invasive~     mechanical ventilation (during one year to reduce the severity and frequency of acute~     exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent~     AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very~     severe COPD). The design is a randomised, double blind and controled with placebo (sham~     maneuver) clinical trial.~   "
120269|NCT01481714|"~     An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of~     colonoscopy. Failure to adequately cleanse the bowel for colonoscopy can lead to missed~     lesions, prolonged procedure duration and repeated procedures at earlier intervals. Emerging~     solid evidence is pointing out the need of switching from preparation the day before to~     regimens in which half or even more of the preparation is administered the same day of the~     procedure, which have extensively demonstrated to provide a significantly better cleansing,~     being well tolerated. Preparation can be fully administered the same day for afternoon~     procedures, whereas split-dose regimens fit better with morning colonoscopies. However, the~     ideal regimen for early morning colonoscopies is still to be elucidated. The second part of~     the preparation for these patients is usually recommended to be taken during sleeping time~     (2-3 am) on the belief that intake of fluids should be completely halted at least four hours~     prior to the colonoscopy procedure Sodium picosulphate is a unique orange-flavoured~     cleansing agent dosed as two powder sachets. Mayor advantages in comparison with current~     alternatives are relatively small volumes (each sachet is mixed with only 150-250 mL of~     water) and a more pleasant taste. It provides similar bowel cleansing than sodium phosphate~     and polyethylene glycol solutions administered the day before. Nonetheless, focus on~     split-dose regimens has been set on several polyethylene glycol (either high-volume or~     low-volume) regimens, but no data are available for split-dose sodium-picosulphate regarding~     colonoscopy in adults.~      The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate~     low-volume split-dose regimen, in which the second-half of the preparation and fluids intake~     are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning~     colonoscopies, comparing this split-dose regimen with standard cleansing the day before with~     sodium picosulphate/magnesium citrate.~   "
120270|NCT01481701|"~     This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant~     tumors Folfox regimen.~   "
120271|NCT01481688|"~     The purpose of this study is to investigate whether intradialytic exercise increases removal~     of waste products from blood, in comparison to the traditional prescription of increasing~     dialysis duration.~   "
120272|NCT01481675|"~     To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb~     (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.~   "
120273|NCT01481662|"~     SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing~     loss, and retinal artery branch occlusions. Since the first description of SS in 1979,~     hundreds of patients with SS, mostly young women, have been reported. However, comprehensive~     epidemiological, clinical and etiological features of SS have never been specifically~     addressed so far.~      The objective of this study is to characterize the epidemiological, clinical, and~     etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a~     national clinical-based cohort including all SS cases retrospectively reported in France~     since the last 20 years and all new cases prospectively observed. French Society of~     Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will~     be reviewed by an expert comity of internists, neurologists and neuroradiologists to~     validate the diagnosis. The exhaustive and systematic analysis of each case will help to~     better define different aspects of the disease such as the incidence and prevalence, the~     clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion~     tensor magnetic resonance imaging of the brain will be obtained to more carefully study the~     cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from~     each patient will also be collected to study potential autoimmune, thrombotic and infectious~     markers.~   "
120274|NCT01481649|"~     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or~     regular virologic monitoring is the preferred method in management patients with prior~     exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation~     (HSCT).~   "
120275|NCT01481636|"~     The purpose of this study is to investigate the correlation between health outcomes~     associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings~     will guide the design of interventional studies.~   "
120387|NCT01480167|"~     The objective of this post market clinical investigation is to evaluate the clinical~     effectiveness of a minimally invasive vertebral augmentation procedure,~     Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative~     management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful~     osteoporotic vertebral compression fractures (VCF).~   "
120276|NCT01481623|"~     Type 1 Diabetes is a multifactorial disease, with a strong genetic contribution of HLA~     genes, and minor contributions of many additional genes. The investigators hypothesis is~     that in addition to multifactorial inheritance, there are subtypes of diabetes that are~     caused by defects in single genes (monogenic diabetes). The aim of this project is to~     identify these genes, based on detailed clinical and characterization of patients, and to~     describe the corresponding genetic diabetes entities with respect to the genetic and~     molecular defect, clinical features and biochemistry. Based on the investigators study~     design, most of these diabetes entities will be caused by mutations affecting the two copies~     of the corresponding gene. In addition, the investigators will study the relatives of the~     patients, and explore if carriers of these genetic defects (i.e. only one copy of the gene~     being defective) may have a predisposition to common forms of diabetes, mainly type 2~     diabetes.~   "
120277|NCT01481610|"~     The purpose of this study is to determine whether the use of lumiracoxib in this particular~     population is associated with a decrease in glomerular filtration rate (GFR) compared to~     diclofenac; and to compare the magnitude of such impairment, if any, associated with use of~     lumiracoxib and diclofenac.~   "
120278|NCT01481597|"~     Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic~     antitumor activity. The purpose of the present study is to investigate the safety and~     pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following~     single-dose administration.~   "
120279|NCT01481584|"~     The objective of the study is to evaluate the nutritional and physiological properties of~     two canola proteins focusing on the bioavailability in humans.~   "
120280|NCT01481571|"~     The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte~     vitrification/warming media and the vitrification device Rapid-i™, when using vitrification~     as a cryopreservation method for human oocytes.~   "
120281|NCT01481558|"~     This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects~     of repeated transcranial direct current stimulation for the treatment of apathy in moderate~     Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.~   "
120282|NCT01481545|"~     The purpose of this study is to evaluate the use of chemotherapy, radiation therapy and~     bevacizumab before surgery in patients with locally advanced rectal cancer (LARC).~   "
120283|NCT01481532|"~     The primary objective of the study is to assess whether human subjects can be made tolerant~     to intravenously administered Crotoxin and achieve higher and more therapeutically effective~     doses levels without the previously reported adverse effects associated with bolus i.m.~     administration.~   "
120284|NCT01481519|"~     Viral conjunctivitis causes redness, tearing, swelling, and irritation of the eyes that~     typically lasts from 1 to 3 weeks. Current management of this condition focuses on~     supportive care while the viral infection completes its course and resolves. However, many~     patients still experience substantial discomfort despite standard treatments, and, given the~     disproportionate morbidity and potential economic impact associated with an outbreak of~     infective conjunctivitis, a therapeutic agent that reduces clinical symptoms of and~     minimizes shedding of infectious virus would be desirable.~      Povidone-iodine is an antiseptic extensively used in preparation for general surgery,~     ophthalmic purposes, and laboratory disinfection. Dilute povidone-iodine solutions inhibit~     numerous viruses, bacteria, fungi, and some other parasites. Low cost, effectiveness, and~     lack of microbial resistance make povidone-iodine an appealing drug to treat ocular~     infections, especially in developing countries. Previously studies showed that~     povidone-iodine is a potential option to reduce contagiousness in cases of adenoviral~     infections. Dexamethasone 0.1%/povidone-iodine 0.4% it is a mixture containing a steroid and~     antiseptic is promising as a suitable therapeutic agent for the treatment of EKC. A small,~     prospective, open-label, single-armed clinical trial of dexamethasone 0.1%/povidone-iodine~     0.4% administration in humans with symptoms of acute conjunctivitis who tested positive for~     adenoviral antigen was therapeutically successful. In other study, dexamethasone~     0.1%/povidone-iodine 0.4% combination markedly lowered the viral concentration and improved~     the manifestations of the disease.~      So, the favorable human data in combination with in vivo results provide a strong impetus~     for a human phase III clinical trial to test the efficacy of this drug in a larger group and~     also to evaluate complete safety to properly establish the therapeutic benefit versus~     adverse effect for these reasons, the investigators chose to study the efficacy of~     dexamethasone 0.1%/povidone-iodine 0.4% in treating the symptoms and signs of viral~     conjunctivitis. The administration of dexamethasone 0.1%/povidone-iodine 0.4% can be a~     secure, tolerable and affective treatment to inflammatory and infective component of acute~     viral conjunctivitis.~   "
120285|NCT01481506|"~     Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and~     disease-related need of care. Selected interventions were able to reduce the number and the~     severity of exacerbations. Telemedicine has also been proposed for this purpose. Current~     evidences, however, are scant. The investigators present a randomized, parallel-group trial~     of a multiparametric remote monitoring system to test its ability to improve early~     exacerbation detection rates and impact on clinical outcomes.~   "
120286|NCT01481493|"~     The study is conducted in order to find out if repeated doses of the monoclonal~     (artificially manufactured) antibody BT061 can help arthritis patients whose disease does~     not sufficiently respond to a treatment with methotrexate (MTX).~   "
120287|NCT01481480|"~     A massive tear of the rotator cuff is a debilitating condition that causes pain, significant~     impairments in strength, and resultant loss of activity of the affected arm. To our~     knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive~     rotator cuff tears. Adding the first randomized controlled trial to will be a substantial~     contribution to the current body of evidence available in the subject of massive rotator~     cuff tears. Most studies found in the literature following patients with massive rotator~     cuff tears are retrospective, have small numbers of patients, offer no control group and do~     not adequately compare treatment methods.Moreover, there is no consensus from experts~     regarding which treatment is superior.~      Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial~     prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the~     treatment of massive rotator cuff tears. This study will include the use of comprehensive~     functional, motor and radiographic outcome assessments.~   "
120305|NCT01481246|"~     The Neurocognitive Study for the Aging (NEUROAGE) was initially funded by the Cyprus~     Research Promotion Foundation and has received subsequent funding by the European Union~     Regional Development Fund. The project focuses on the understanding of the effects of age on~     neurocognitive abilities such as attention, memory, language, categorization, and executive~     functioning. In addition, it also investigates the effects of a theory-driven hierarchical~     training program, the Categorization Program, to improve cognitive abilities in adults with~     Mild Cognitive Impairment (MCI). Over 700 adults ages 50 and older participate in the~     project. The grant was awarded to the University of Cyprus.~   "
120306|NCT01481233|"~     The purpose of this study is to determine the prostate specific antigen response to~     continuous low dose oral colchicine.~   "
120288|NCT01481467|"~     Influenza is a serious disease which can cause severe illness and even death among patients.~     Health care workers (HCWs) often get infected with influenza and up to 76% of them keep~     working while being ill. Immunizing HCWs is therefore an essential factor in protecting~     patients from influenza as HCWs easily transmit influenza to their patients.~      However, despite recommendations from the Dutch Health Council since 2007, vaccine uptake~     among HCWs remains low.~      The aim of this study is to develop an effective implementation strategy on the basis of~     previous behavioural studies and to evaluate its value in a clustered randomized trial in~     all Dutch University Medical Centers (UMCs). Also, we want to assess the program elements~     that are associated with a higher vaccine uptake and the cost-effectiveness of such an~     implementation strategy.~      The results of this study will give more insights in the way influenza vaccination campaigns~     should be directed in order to achieve high vaccine uptake rates among HCWs in hospitals.~   "
120289|NCT01481454|"~     The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine~     (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune~     response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).~      Primary Objective:~        -  To describe the safety profile (injection site reactions and systemic events) of each~          vaccine during the 21 days following vaccination, and serious adverse events (including~          adverse events of special interest) throughout the study in all adult and~          child/adolescent participants.~      Secondary Objectives:~        -  To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine~          (QIV) induce an equivalent immune response at 21 days post-vaccination in both age~          groups (lot consistency)~        -  To describe the compliance of the immunogenicity of QIV to the European Medicines~          Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.~   "
120290|NCT01481441|"~     With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised~     with the potential to improve ultrasound imaging for prostate cancer detection and~     localisation significantly. The past years numerous studies have been performed with CEUS,~     all basing their results on subjective judgement of the investigator. CEUS image~     interpretation is difficult and requires a well-trained expert. To overcome these~     difficulties CEUS quantification techniques can be of use. The techniques used in this~     protocol have been developed in cooperation with the Technical University in Eindhoven~     (TU/e) and BRACCO, Geneva.~      The investigators hypothesize improvement of the PCa detection rate with quantification,~     compared with subjective CEUS interpretation and known numbers in literature.~      Also a comparison between quantification results and tumour differentiation grade (Gleason~     score) will be made, the investigators hypothesize a positive correlation.~   "
120291|NCT01481428|"~     This study will be the first to examine the efficacy of using a brief, computerized HIV risk~     reduction intervention in treatment courts.~   "
120292|NCT01481415|"~     The investigators study is trying to find the normal value to left atrial volume and left~     atrial function in healthy children by tridimensional real time echocardiography avaluation.~   "
120293|NCT01481402|"~     Purpose: The purpose of the study is to examine if treatment with liothyronine increases~     left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.~   "
120294|NCT01481389|"~     The purpose of this study is to determine the effect of theobromine on blood lipid~     parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa~     and an interaction effect of cocoa and theobromine on blood lipid parameters.~      Hypothesis: theobromine has a positive effect on blood lipid parameters.~   "
120295|NCT01481376|"~     The objective of this retrospective study is to evaluate the postoperative clinical outcomes~     at discharge, 1 month and 12 months, associated with the use of Parietex™ ProGrip™ in~     Laparoscopic Transabdominal preperitoneal inguinal hernia repair. Results from this study~     will be used to support the short- and long-term clinical outcomes of Parietex™ ProGrip™~     when used in inguinal hernia repair by laparoscopic approach.~        -  Single center study~        -  Population: All subjects have undergone Laparoscopic Transabdominal preperitoneal~          surgical treatment for inguinal hernia repair with Parietex™ ProGrip™ without~          additional fixation between September 2008 and March 2010 (inclusive) with at least 12~          months of follow-up.~      The primary outcome:~      • Proportion of subjects who experience hernia recurrence (defect treated initially with~     Parietex™ ProGrip™) within 12 months post-surgery.~      Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a~     Valsalva maneuver in the operated groin.~      The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the~     recurrence diagnosis is confirmed during a physical examination by a physician and defined~     as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the~     operated groin. If subject has a surgical repair of the hernia within the 12 month~     postoperative period, it will be documented as evidence of hernia recurrence.~      The secondary outcome:~        -  Incidence of Groin Pain (pain score 0-10) and analgesic use at discharge, 1 month and~          12 month postoperatively~        -  Incidence of postoperative complications including, wound infection (any infection of~          the incision), mesh infection (an infection of the mesh), bleeding, mesh migration,~          mesh erosion, fistula, small bowel obstruction, seroma, hematuria, hematoma,~          inflammation, chronic pains/ inguinodynia, infection, visceral adherence, allergic~          reactions to the components of the product at discharge, 1month and 12 month~          post-operatively~        -  Patient satisfaction~        -  Operative time~        -  Hospital length of stay~   "
120296|NCT01481363|"~     Do family carers of people with dementia benefit from communication therapy and training?~     This study will only involve carers of people with dementia. Nearly all people with dementia~     will experience some difficulty communicating. Family carers of people with dementia have~     described communication and associated behaviour difficulties as one of the hardest to cope~     with.~      This is a PhD study. The student/investigator has previously produced a detailed manual of~     approaches for supporting relatives of people with dementia who are experiencing~     communication difficulties. Previously published communication guides by other authors do~     not present research evidence.~      Carers will be recruited to this study from the local NHS older person's mental health~     service overseen by their relative's psychiatrist. Only family carers will be included.~     Recruits will be randomly assigned to a treatment group or a control group. People in the~     control group will receive treatment as usual. The carers will be seen at home or at an NHS~     site if they prefer. The investigator and carer will work through the contents of the manual~     together. The manual is designed to consider their knowledge, thinking, skills and~     behaviour. The treatment will take no more than 4.5 hours over a period of up to 12 weeks.~      Carers will be asked to complete questionnaires before and after the treatment. As well as~     background information, these questionnaires will look for any significant effects of the~     treatment on carers' anxiety and depression, carers' quality of life, carers' belief in~     their ability to care, communication difficulties experienced and the carers perceptions of~     their relatives communication competence.~      A sample of 15 carers will also be interviewed by a third party interviewer who will be an~     existing speech and language therapy employee of Solent NHS Trust (see attached job~     description and person specification). The interviews will ask more specifically about their~     thoughts, feelings and opinions of this intervention and their experience in addressing~     communication difficulties.~   "
120297|NCT01481350|"~     Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac~     surgery for valvular heart diseases, especially in patients with a long life mitral valve~     disease. The present study wants to test the hypothesis that intravenous administration of~     sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.~   "
120427|NCT01479647|"~     The purpose of this study is to investigate the effect of food on the time course of~     PH-797804 concentration in the blood following dosing by oral immediate release tablet~     formulation.~   "
120298|NCT01481337|"~     The endoscopic management of patients on anti platelet agents is a wide problem more and~     more common, with prevalence of patients on this type of therapy steadily increasing. The~     risk of bleeding on antiplatelet during an endoscopic examination can be major. The risk of~     cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently~     described as significant (4-5%). Current recommendations for polypectomy allow the gesture~     as aspirin and are based on literature data scarce, often retrospective. Such work may be~     for a lack of increased bleeding risk during a colonic polypectomy under aspirin. There is~     to date no significant data published on the implementation of the endoscopic mucosal~     resection (mucosectomy) under aspirin. It is necessary to achieve a national multicenter~     observational study on a large scale in the daily practice of colonic polypectomy /~     mucosectomy in patient taking aspirin.~      The aim of the study is to determine the incidence of immediate and delayed bleeding colonic~     polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a~     long-term aspirin therapy and presenting a major risk of thromboembolism or medium will~     incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy~     after signing a specific consent. Polypectomy will be possible according to the~     recommendations of the French Society of Digestive Endoscopy. Upon discovery of a lesion to~     be resected by mucosectomy, the patient will benefit from the mucosectomy. The study is~     observational, multicenter, prospective, national. The polypectomies / colonic mucosectomies~     will be made using the conventional techniques and the current recommendations. The~     immediate and delayed hemorrhage meet specific definitional criteria. The number of patients~     to be included will be 1000. The duration of the study inclusions will be 36 months. The~     trial will be conducted in full compliance with laws, regulations and ethical aspects.~      It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is~     the same. The rate of bleeding reported in the post mucosectomy size is higher compared to~     the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy~     with or without aspirin is indifferent. It will follow a recommendation of French society~     adapted to endoscopy for this type of procedure~   "
120299|NCT01481324|"~     It has been shown that compliance with brace wear can significantly improve the treatment~     outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be~     around 30-41% with initial orthosis wear after successful treatment with serial castings.~     These studies have depended on family logs and not objective data. With the development of a~     monitoring device, this study hopes to examine: (1) actual patient compliance, (2)~     comparisons of actual wear time and assumed wear time and (3) the relationship of patient~     wear with clinical outcomes.~      Hypothesis:~      Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported~     compliance and noncompliance is correlated to future surgeries.~   "
120300|NCT01481311|"~     The aim of this clinical investigation is to prove that the seca mbca detects dialysis~     patients with abnormal water distribution correctly. Abnormal high water distribution is~     defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and~     Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects~     generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution~     methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method~     should be evaluated to the accuracy of the absolute measurement of the volume state of~     dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.~   "
120301|NCT01481298|"~     Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous~     excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses~     communicating with the ventricular cavity and severely altering myocardial structure.~     Although most authors assume a developmental arrest in embryogenesis as the underlying~     pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have~     been identified to be linked with LVNC and an autosomal dominant inheritance pattern is~     frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography~     applying the criteria established by Jenni and coauthors However, qualitative parameters to~     differentiate normal compaction of the myocardium in healthy subjects from LVNC or from~     other cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy~     (HCM) may fail due to highly variable LV trabeculation. Therefore, absolute quantification~     should be performed. Cardiac magnetic resonance (CMR) has been reported as a promising~     imaging modality to characterize patients with LVNC as it provides both a high spatial~     resolution and a good contrast between trabeculation and blood pool Jacquier et al. recently~     described a value of trabeculated LV myocardial mass above 20% of the global mass of the LV~     to be highly sensitive and specific for LVNC However, in their approach, a substantial~     degree of the LV cavity was included into calculated trabecular LV mass and led to systemic~     overestimation of the latter. Furthermore, the role and prognostic value of myocardial~     scarring as assessed by delayed enhancement (DE) CMR was not evaluated.~      The aim of the retrospective study was to establish revised and extended CMR criteria to~     distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment~     of trabeculated mass by excluding intertrabecular blood pool.~   "
120302|NCT01481285|"~     The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of~     FMI and FFMI is based on the results of two other clinical investigations: Generation of~     prediction equation to analyze body composition of adults based on Bioelectrical Impedance~     Analysis (BIA) (BCA-01) and Application and adaption of device specific body composition~     formulas to various ethnic groups (BCA-02). The aim of BCA-01 was to develop prediction~     equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods~     ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the~     other hand. The equations are necessary to use the device as a Body Composition Analyzer~     with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to~     apply and adapt device specific body composition formulas to various ethnic groups.~   "
120303|NCT01481272|"~     It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity~     of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim~     (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in~     combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell~     lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous~     Stem Cell Transplant (ASCT).~   "
120304|NCT01481259|"~     Maintenance therapy has been considered as an important component to prolong survival in~     patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have~     confirmed that pemetrexed is one of the effective drugs in improving progression-free~     survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic~     deliveries of pemetrexed, however,the functioning status and immune system may get worse,~     which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with~     autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism~     through stimulating immune response and altering the interaction between tumor and its host.~     This effect may result in improved tumor control and survival, as well as a better quality~     of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK~     cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell~     lung cancer.~   "
120353|NCT01480622|"~     This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF)~     300 mg in Chinese subjects to support the registration of this compound in the People's~     Republic of China. This will be an open-label, single group, single and repeat dose study~     without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable~     measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after~     the single dose and at steady state. The duration of the study will be approximately 7 weeks~     from screening to follow-up.~   "
120307|NCT01481220|"~     Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which~     may lead to bleeding complications. Treatment with cytotoxic agents can decrease the~     platelet levels further. Eltrombopag is a relatively new drug that increases the platelet~     level in the blood by working directly on the bone marrow. It is available for treatment of~     the disease Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS~     and low platelet levels that are treated with the cytotoxic agent Azacitidine will also~     receive Eltrombopag. The administration of Eltrombopag to MDS patients treated with~     Azacitidine may result in less dose reductions and less treatment delays for Azacitidine and~     may reduce the need for thrombocyte transfusions and lower the risk of bleeding~     complications.~      This is a phase I study, meaning that our major goal is to investigate the safety and~     tolerability for Eltrombopag in this patient group. It will also generate a basis for a~     phase II-III-study.~   "
120308|NCT01481207|"~     Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition~     characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is~     thought to affect approximately 0.2% of live births, and is associated with a high risk of~     mortality or long-term neurological disability.~      Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely~     important both for clinical management and the evaluation of therapeutic approaches.~     According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and~     N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance~     spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome~     following HIE. However, for various technical reasons standard MRS methods do not offer~     optimal sensitivity for detecting lactate, which may potentially be improved with a custom~     lactate editing MRS sequence. In addition, while perfusion has also been suggested as a~     potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR~     perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has~     not been evaluated in comparison with more established MR biomarkers. The aims of this study~     are:~        1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence~          (specialist software) relative to the standard point resolved (PRESS) MRS sequence for~          detecting lactate in neonates with suspected HIE.~        2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to~          MRS measures as predictors of neuro-developmental outcome at 2 years.~   "
120309|NCT01481194|"~     The purpose of this study is to evaluate the efficacy and safety of the combination~     treatment of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in~     newly diagnosed multiple myeloma patients.~   "
120310|NCT01481181|"~     In low-income settings in developing countries unsafe water is one of the leading causes of~     high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element~     that has a critical role in growth and immunity. Supplementation with zinc is considered~     effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard~     Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called~     LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological~     contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of~     the study is to assess the efficacy of LSF to increase the zinc status (serum zinc~     concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study~     hypotheses are:~      A. Use of the LSF device will reduce microbiological contamination of the household supply~     of drinking and cooking water; B. Use of the LSF device will increase zinc intakes in~     preschool children; C. Use of the LSF device will increase serum zinc concentration in~     preschool children; D. Achieving A, B and C will improve growth in preschool children; E.~     Achieving A, B and C will reduce the frequency and duration of diarrheal disease in~     preschool children and in members of the participating households.~   "
120311|NCT01481168|"~     The purpose of this study is to determine whether or not the intravenous adenosine test~     readily identifies patients with unexplained syncope who would benefit from permanent~     pacemaker implantation.~   "
120312|NCT01481155|"~     The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy~     is superior in the treatment of actinic keratoses with respect to efficacy and side effects.~   "
120313|NCT01481142|"~     The objectives of the study are to observe and document the efficacy and safety of 5 or more~     Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of~     ulcerative colitis patients. The patient subset of interest is those with moderate/severe,~     steroid-dependent, active ulcerative colitis with insufficient response or intolerance to~     immunosuppressants and/or biological agents.~   "
120314|NCT01481129|"~     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients~     with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
120315|NCT01481116|"~     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2~     diabetes mellitus (T2DM).~      The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2~     diabetes mellitus (T2DM).~   "
120316|NCT01481103|"~     This research is being done to study the effect of incorporating acupuncture into the~     management of migraines. The primary aim is to determine in a randomized, controlled study~     whether individuals experiencing migraines have fewer occurrences and less intense migraines~     when acupuncture is integrated with nonprescription pharmacological treatment.~     Nonprescription pharmacological treatment in this study refers to the use of the following~     over the counter medications: Aspirin, Ibuprofen, Naproxen, Acetaminophen (with or without~     caffeine). Aspirin, Ibuprofen, and Naproxen are members of a class of drugs known as~     non-steroidal anti-inflammatory drugs or NSAIDs.~   "
120354|NCT01480609|"~     This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8~     patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving~     haemodialysis. Patients will remain in the unit during each treatment period from admission~     to the collection of the final PK sample. The doses of ezogabine/retigabine in the two~     treatment periods will be separated by at least 7 days.~   "
120428|NCT01479634|"~     A study of antiretroviral therapy (ART) initiation under a streamlined model of care in~     HIV-positive patients with CD4+ cell counts greater ≥ 250 cells/uL~   "
120317|NCT01481090|"~     One of the most widely used procedures in reproductive medicine technologies is In Vitro~     Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are~     frozen to be used at later times. If these embryos are thawed and transferred back to the~     mother, proper development of the uterine lining plays an important role in outcome of~     pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the~     needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing~     the likelihood of developing a more ideal endometrial lining. This randomized study aims to~     evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle~     preparation. The treatment group will receive four acupuncture treatments during the~     medicated uterine preparation. Endometrial thickness will be compared to a group that does~     not receive acupuncture.~   "
120318|NCT01481077|"~     The purpose of this study is to determine the effect of plug placement on the efficacy,~     safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).~   "
120319|NCT01481064|"~     The purpose of this study is to evaluate the effects and costs of a multifaceted approach on~     the patient-centredness of fertility care and the quality of life of fertility patients.~   "
120320|NCT01481051|"~     The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS~     (latanoprost punctal plug delivery system) at different dose levels.~   "
120321|NCT01481038|"~     Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are~     performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from~     CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis~     or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The~     aim of the project is to investigate a more sensitive and specific test for anticipative~     diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.~   "
120322|NCT01481025|"~     Climacteric Complains bring to women many problems for living a normal life - hot flashes,~     irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new~     horizon for this part of time.~   "
120323|NCT01481012|"~     The purpose of this study is to obtain data or information on how blood clotting factors are~     activated during open heart surgery. In particular, the investigators are interested in how~     blood clotting factors are activated by the heart-lung bypass machine and by left~     ventricular assist devices (LVAD). Patients on these two machines have an increased risk of~     bleeding and blood clot formation. This is because both machines stimulate the intrinsic~     coagulation pathway, one of the chemical pathways that cause blood to clot. The process of~     surgery itself also stimulates the extrinsic coagulation pathway, the other chemical~     pathway that causes blood to clot. Stimulating these coagulation pathways can use up the~     body's clotting factors. As a result, patients may be at risk for both bleeding and blood~     clot formation. The investigators would like to study how the blood factors are activated~     during and after surgery, to help develop treatments to prevent bleeding and clot formation.~   "
120324|NCT01480999|"~     The use of robotic surgery in the management of gynecologic cancers has increased~     exponentially in the United States since the implementation of technology in 2005. In~     Canada, access to the system is limited because of a lack of government funding. The~     government has been reluctant to fund this technology because robust data, on the true~     impact to patient care, is lacking.~      This project will prospectively examine outcomes of women, with early stage endometrial~     cancer, treated surgically. Open surgery will be compared to minimally invasive surgery~     (MIS) which will include conventional laparoscopy and robotic surgery. The data collected~     will include detailed assessment of surgical data, peri-operative events, quality of life~     analysis, health economic evaluation and evaluation of MIS rates.~   "
120325|NCT01480986|"~     This is a prospective, single-armed, open label study on the efficacy and safety of~     sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI~     poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the~     phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished~     without disease progression or progression occurs during the treatment, the patient will~     enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint~     is progression free survival in the two steps respectively and secondary endpoint is disease~     control rate, overall survival and safety~   "
120326|NCT01480973|"~     NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30%~     of all cancer deaths. The standard treatment for patients with early-stage non-small-cell~     lung cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients~     are unable to undergo such a major surgery due to medical illness, and an emerging~     standard-of-care for these patients stereotactic-body radiation therapy (SBRT).~      SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few~     fractions (hypofractionation) to accurately describe, size-restricted malignant targets in~     which motion has been accounted for during the delivery process. SBRT administration~     achieves avoidance of normal tissue exposure to radiation during the planning process, by~     providing for sharp fall-off dose gradients outside the target.~   "
120327|NCT01480960|"~     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy~     in patients following lung transplantation. Exercise training has been shown to be a~     cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve~     exercise performance. In our study we will investigate the benefit of a whole body vibration~     training in addition to a standard pulmonary rehabilitation program that includes endurance~     and strength training. We will include a total of 140 patients (70 patients < 1 year after~     lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is~     that an addtitional whole body vibration training produces a greater benefit to exercise~     capacity in lung transplantat patients (LTx).~   "
120356|NCT01480583|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in~     patients with brain metastases from breast cancer. For patients with HER2 positive~     metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab~     (Herceptin®) as per standard-of-care practice.~      In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of~     change in the uptake in the brain metastases from breast cancer after GRN1005 treatment,~     correlates with intra-cranial response (for patients enrolled at NCI).~   "
120328|NCT01480947|"~     Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are~     infected by rotavirus or salmonella.~      Base on the past researches, there is benefit effect of probiotics on patients with diarrhea~     or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three~     independent probiotics, will be used in patients with acute diarrhea.~      This is a single site, controlled clinical research. About 80 patients will be enrolled into~     this study to evaluate the benefit effect of bio-Three among patients with acute enteritis~     due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and~     screened by inclusion and exclusion criteria and only eligible patients will be enrolled~     into this study.~   "
120329|NCT01480934|"~     To compare the development of posterior capsule opacification (PCO) between eyes with and~     without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic~     intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not~     increase the incidence of PCO at 4 years.~   "
120330|NCT01480921|"~     The objective of this study is to compare the effect of monitored, home-based exercise~     versus hospital-based exercise on the quality of life of patients with congestive heart~     failure. Secondary objectives are to assess the effect of the intervention on exercise~     capacity and caregiver burden.~      The investigators hypothesize that the exercise training in the home-based environment will~     be superior to hospital based exercise training.~   "
120331|NCT01480908|"~     The most common congenital heart disease is the ventricular septal defect, and after~     surgical closure of a such defect, an arrythmia called the right bundle branch block, is~     very frequent. Therefore the aim of this study is to investigate if this group of patients~     has inferior outcomes compared to the group without this arrythmia after surgical closure~     and compared to a group of healthy control subjects.~      All patients will be undergoing 1. exercise testing, 2. echocardiography, 3.~     echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a~     group of patients with a possible need of further intervention, and additionally to increase~     the awareness of protecting the electrical system of the heart during the operation.~   "
120332|NCT01480895|"~     Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long~     term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM)~     is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM~     incidence in Jewish and Bedouin women has been rising in recent years. It has been reported~     in many studies that women who had been diagnosed with GDM are more prone to GDM in their~     next pregnancies and to DM Type 2.~      Appropriate changes in everyday diet and physical exercise may reduce the chances for future~     GDM and type 2 DM.~      The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin~     populations and to construct a plan for follow up and reduce future problems by changing~     their life style.~   "
120333|NCT01480882|"~     A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine~     which is supposed to mimic the chest percussion performed by professional physiotherapist to~     mobilize sputum through the respiratory passage.~      The aim of this study is to compare the effectiveness and safety of this mechanical~     percussion device in the treatment of airway clearance with conventional chest physiotherapy~     carried out by qualified physiotherapists in patients suffering from bronchiectasis or~     Chronic obstructive Pulmonary disease (COPD).~   "
120334|NCT01480869|"~     The purpose of this study is to compare normalization of vitamin D serum level after 6~     months of vitamin D supplementation adjusted to baseline vitamin D serum level~     vs.conventional vitamin D supplementation.~   "
120335|NCT01480856|"~     Cobedding consists of associating twins in a common cocoon in order to maintain links~     developed in utero and reduce the stress of premature birth. The aim of this randomized,~     controlled prospective study is to compare efficacy (in term of newborn daily weight gain)~     and safety of cobedding versus single-bedding of preterm twins.~   "
120336|NCT01480843|"~     The purpose of this study is to find out if simplifying your diabetes treatment by~     decreasing number of insulin injections, with the help of a long acting insulin called~     glargine, can decrease the episodes of low blood glucose.~   "
120337|NCT01480830|"~     Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In~     Canada, up to 13% all colonoscopies do not examine the full colon and are therefore~     incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to~     twists and turns in the colon that make the colonoscopy difficult to perform and~     uncomfortable for the patient.~      This randomized study is being done to test a new colonoscopy system called the Scope Guide~     that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the~     patient's abdomen.~      We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of~     colonoscopy quality including rate of complete examination, patient comfort, polyp detection~     rate, insertion time, amount of sedation required, and need for abdominal compression.~   "
120338|NCT01480817|"~     The investigators are going to compare the therapeutic effect of sorafenib and transarterial~     chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein~     invasion.~   "
120339|NCT01480804|"~     The purpose of this research study is to identify barriers affecting self care in older~     patients with diabetes and to provide coping strategies for these barriers with help from a~     care manager (Geriatric Life Specialist) to improve clinical, economical, functional and~     psychosocial parameters.~   "
120355|NCT01480596|"~     Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of~     belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with~     MG. The study will enroll male and female outpatients (> or equal to 18 years of age) with a~     diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle~     specific kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3)~     continue to exhibit signs of MG. The study will include 3 phases: a 4 week screening period,~     a 24 week treatment period, and a 12 week follow-up period. IP will be administered~     intravenously on Days 0, 14, 28 and then every 28 days through and including Week 20. At~     Week 24, primary outcomes will be obtained. Follow up evaluations will be conducted at Weeks~     28, 32 and 36 for all subjects. The primary objective of this study is to assess the~     efficacy of belimumab as evaluated by the change in the quantitative myasthenia gravis (QMG)~     score.~   "
120494|NCT01478763|"~     Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative~     diabetic retinopathy~   "
120340|NCT01480791|"~     This study will be performed only at the Jewish General Hospital. It will investigate the~     effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the~     kidney that constricts arteries and raises blood pressure, on the blood vessels,~     specifically the arteries, of subjects who have diabetes and elevated blood pressure~     (hypertension).~      To investigate blood vessels, different techniques will be used. For large arteries, these~     will be studied by non invasive methods using detection of the pulse wave or using~     ultrasound over the skin of the neck, the wrist and the groin. To study small vessels, the~     investigators will perform a biopsy on the buttock, under local anesthesia, and obtain a~     small sample of tissue from under the skin, from which the vessels will be dissected. The~     investigators have performed many hundreds of these small biopsies over the past 20 years~     for similar studies without any complications. The biopsies are very well tolerated. From~     this research the investigators will thus be able to learn what the structure and function~     of these vessels is in these patients, in comparison to a normal healthy group.~      The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to~     treatment with the renin inhibitor aliskiren or a comparator, the diuretic~     hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is~     very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic~     individuals. The diuretic is a well-know agent used to treat high blood pressure now for~     many years, and which is very well tolerated. Physicians, nurses and scientists involved in~     the study will be unaware of who is receiving which drug, as will be the patients (this is~     the meaning of double-blind trial). However, if there is any problem, the secret code will~     be broken and the individual withdrawn from the study. Subjects will be treated for a year,~     and the study procedures (non invasive and the biopsy) repeated at 6 months and after one~     year of treatment. During the study, blood samples will be drawn and urine collected at~     certain intervals to ensure safety of the treatment.~      Once tissues are obtained they will be studied in the laboratory. The study of the vessels~     will allow treatment us to determine how the treatment with the renin inhibitor aliskiren~     affects the structure and function as well as cellular and molecular aspects of arteries of~     hypertensive diabetic persons. The investigators expect these studies to provide us~     knowledge on mechanisms and perhaps new targets for future therapies of cardiovascular~     disease and hypertension.~   "
120341|NCT01480778|"~     Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química~     Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical~     Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by~     measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation~     demonstrated by transvaginal ultrasound examinations~   "
120342|NCT01480765|"~     The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery~   "
120343|NCT01480752|"~     To determine the effect of intraligamentary injection of Lornoxicam on the intensity of~     post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.~   "
120344|NCT01480739|"~     Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and~     function (phagocytosis and oxidative burst) in the circulation, following a burst of~     strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating~     factor (G-CSF)~   "
120345|NCT01480726|"~     Vena saphena magna is still frequently used as graft material in coronary artery bypass~     grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh =~     open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein~     harvesting). The endoscopic techniques have been shown to reduce the incidence of~     postoperative wound complications while patients are more satisfied with the cosmetic result~     of the operation on the leg.~      Non-randomized studies have raised doubts about patency rates of the vein grafts following~     EVH compared to OVH, while other studies failed to detect any problems in relation to this.~     There are only very few data on long-term patency rates from randomized studies.~      The purpose of this study is to investigate clinical outcome and patency rates of the vein~     grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as~     part of a randomized study investigation wound complications. A cost-effectiveness analysis~     will also be performed.~      The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years~     postoperatively.~   "
120346|NCT01480713|"~     This is a pilot, proof of concept, open-label clinical trial, to assess the extend of~     persistent viral reservoir and the level of immune activation in patients receiving~     suppressive treatment with protease inhibitors.~      40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted~     lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA~     per ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included.~      The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks~     of follow-up once the last patient is included, and 12 weeks for data analysis.~   "
120347|NCT01480700|"~     This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin~     from lucerne protein concentrate and DHA from microalgae on the plasma levels of these~     compounds but also on the macular pigment optical density, whose elevation may be beneficial~     in the prevention of Age-related Macular Degeneration (AMD).~   "
120348|NCT01480687|"~     The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty~     acid supplementation on the vascular structure and function in hypertensive patients with~     hypertriglyceridemia.~   "
120349|NCT01480674|"~     This observational study will characterize retrospectively patients with HER2-positive~     metastatic or locally advanced breast cancer who had received treatment with Herceptin~     (trastuzumab) in 1st line and who were without progression for at least three years.~     Patients will be followed prospectively for one year.~   "
120350|NCT01480661|"~     In this study the possible changes in airway geometry and function induced by 6 month oral~     treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory~     imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients~     will be examined. The study population consists of 40 severe COPD patients, global~     initiative for chronic obstructive lung disease (GOLD) stages III until IV.~      Imaging parameters will be assessed and the correlation with lung function and health~     related quality of life will be checked before and after treatment.~   "
120351|NCT01480648|"~     This first-in-man trial forms the basis for potential clinical development of BI 144807 in~     the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics,~     and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male~     volunteers.~   "
120352|NCT01480635|"~     Purpose of study:~      To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard~     colonoscopy~      Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects~      Subject population: Patients that are indicated for colonoscopy, who are suspected or known~     to suffer from colonic diseases and had an incomplete standard colonoscopy~      Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One~     week follow up Duration of study: 12 months~      Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon~     segment not reached by an incomplete standard colonoscopy Evaluation of distribution of~     excretion of capsules over time~   "
120357|NCT01480557|"~     Objective of this study is the comparative assessment of the impact of torsional and~     liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal~     sensitivity (CCS) in a sample of cataract patients.~      Participants were recruited from the Cataract Service of the UHA in a~     consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract~     with stage 2 nuclear opalescence according to the Lens Opacities Classification System III~     (LOCS-3) grading scale [10]. By means of a custom computer randomization program all~     participants randomly populated two study groups according to the cataract-extraction~     technology used: a) Torsional group (TG) and b) Liquefaction group (LG).~   "
120358|NCT01480544|"~     The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi~     Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka,~     India in order to determine its policy value and to guide efforts to improve maternal and~     infant health outcomes nationally. In addition, the study includes a large randomized~     evaluation of performance-based incentive payments to providers to improve quality of~     medical care provided during delivery and actual health improvement in the providers'~     patient populations and their catchment areas.~   "
120359|NCT01480531|"~     2. Purpose of the Study -~        1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining~          individually specified patient BP target ranges in the pre and postoperative periods of~          aortic aneurysm and dissection management.~        2. To determine the safety of Clevidipine use in the pre and postoperative periods of~          aneurysm and dissection management~        3. Background & Significance - Surgical treatments for persons with aortic root/arch~          dissection or aneurysm have significantly improved survival. However, critical in~          management of these patients is precise control of blood pressure (BP). With increasing~          BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is~          imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal~          cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the~          target systolic blood pressure range for these patients is 100-120 mmHg.~           Several different classes of vasoactive agents are in current use to acutely manage BP~          but none possess the optimal profile of an ideal vasodilator. Notable limitations~          include inadequate potency, slow onset and offset of action, multiple receptor~          function, safety concerns and, importantly, restricted/ineffective titration, which~          results in clinically significant hemodynamic and cardiovascular perturbations.~           Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker~          clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in~          critical care settings.~           Clevidipine's pharmacology lends itself to acute management of BP in a broad critical~          care setting in both surgical and nonsurgical patients. In the current study, the~          investigators propose to further characterize the hemodynamic effect of CLV in the pre~          and post-operative management of BP in patients with aortic aneurysm/dissection.~        4. Design & Procedures Eligible patients will be approached to participate in the study by~          the Intensive Care Unit (ICU) attending and/or by a cardiothoracic~          surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical~          management and monitoring will be according to standard practice that includes:~             -  ECG~             -  Oxymetry~             -  Temperature~             -  Invasive arterial blood pressure~             -  Recording of routine laboratory results~             -  Imaging studies including CT/MRI (A)/ Echocardiography~             -  Pulmonary artery catheter (postoperative patients)~             -  Mechanical ventilation (postoperative patients)~             -  According to established protocol for acute intravenous management of arterial~               blood pressure in these patients, an upper and lower threshold of systolic blood~               pressure will be prescribed by the attending physician (the range being (100 mmHg~               -120 mm Hg SBP).~      Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent~     clinical data and information about efficacy and safety will be recorded.~      • Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the~     critical care team)~   "
120360|NCT01480518|"~     RATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about~     changes that occur in DNA and identify biomarkers related to cancer. It may also help~     doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     Ewing sarcoma.~   "
120361|NCT01480505|"~     Purpose:~      To assess the functional and anatomical outcome of primary vitrectomy without scleral~     buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length~     over 30 mm.~      Methods Design: Retrospective single center series. Setting: University Hospital. Patients:~     High myopic patients treated with primary vitrectomy without scleral buckling for a~     rhegmatogenous retinal detachment.~      Outcome measures: Anatomical success rate with complete reattachment of the retina without~     silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).~   "
120362|NCT01480492|"~     During hepatitis B virus(HBV) infection host immune plays important role.Recently there are~     many different antiviral therapy methods.Different antiviral therapy methods showed~     different effector.In order to investigate whether these antiviral therapy methods~     especially methods directly inhibit viral replication have some effect on host immune the~     investigators designed these study. The investigators want to observe the change of host~     immune during antiviral therapy in patients with chronic HBV infection, and analyze the~     relationship between these changes and the antiviral effector of these drugs.~   "
120363|NCT01480479|"~     This 2-arm, randomized, phase III study will investigate the efficacy and safety of the~     addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer~     effects in patients who have tumors that express the EGFRvIII protein) to the current~     standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of~     brain cancer.~      All patients will be administered temozolomide, the standard treatment for glioblastoma.~     Half the patients will be randomly assigned to receive rindopepimut and half the patients~     will be randomly assigned to receive a control called keyhole limpet hemocyanin.~      Patients will be treated in a blinded fashion (neither the patient or the doctor will know~     which arm of the study the patient is on). Patients will be treated until disease~     progression or intolerance to therapy and all patients will be followed for survival.~   "
120364|NCT01480466|"~     Overweight and obesity are highly significant clinical and public health issues, affecting~     more than two-thirds of adults in this country; however, primary care clinicians often do~     not document overweight or obesity or discuss weight management with their patients. The~     objectives of the proposed research are to develop and evaluate a set of tools within~     electronic health records (EHRs) to assist primary care clinicians with the diagnosis and~     treatment of overweight and obesity and to help patients manage their weight.~   "
120365|NCT01480453|"~     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal~     Humeral Stem when used in primary, total or hemi shoulder arthroplasty.~   "
120366|NCT01480440|"~     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal~     Reverse Shoulder System when used in primary or revision reverse total shoulder~     arthroplasty.~   "
120367|NCT01480427|"~     The purpose of this study is~        1. To validate in french quality of life questionnaires for food allergic children~        2. To evaluate if the quality of life of food allergic french speaking children aged 0-12~          years is affected by their condition~        3. To validate a didactic game for food allergic children~   "
120368|NCT01480414|"~     Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb~     perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic~     needs of the tissue, even under resting conditions. The limits of peripheral artery disease~     (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have~     been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults~     older than 55 years. Formation of true new blood vessels, or angiogenesis, and development~     of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the~     pathophysiology of vascular disease. By stimulating these processes the investigators might~     be able to provide an alternative treatment strategy for patients with lower limb ischemia.~     In response to tissue injury and remodeling, neovascularization usually occurs via the~     proliferation and migration of progenitor endothelial cells (EPC) from preexisting~     vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC)~     implantation increases collateral vessel formation in patients with limb ischemia. So the~     investigators determine to evaluate the efficacy of repeated MNC transplantation in patients~     with ischemic lower limb.~   "
120369|NCT01480401|"~     This study aims to identify the relationship between a low-sodium diet and neurohormonal and~     clinical status in stable chronic HF patients.~   "
120370|NCT01480388|"~     The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979~     at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance)~     in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate~     (MTX).~   "
120371|NCT01480375|"~     Prostate biopsy is a procedure in which small samples are removed from a man's prostate~     gland to be later tested for the presence of cancer. It is typically performed when the~     scores from a PSA blood test rise to a level that is associated with the possible presence~     of prostate cancer.~      The most common method for performing a prostate biopsy procedure is the ultrasound guided~     transrectal procedure. The information obtained from the standard prostate biopsy is~     deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy.~     Moreover, the detection of a tumor cannot predict accurately the tumor size and location1.~     It was proven that the exact location of the obtained cores, even in an initial biopsy, can~     influence the cancer detection rate2.~      An imaging tool that will enable a three-dimensional navigation in the prostate volume and~     selecting biopsy locations in view of previous core taken will allow building a tumor map~     '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate~     treatment can be chosen while avoiding over or insufficient treatment.~      However, to be able to produce an accurate mapping of the malignant tissue, a complementary~     optimized pathology method should be also implement in addition to the navigation system, it~     has been shown that a pre-embedding procedure that keeps the specimen orientation,~     unfolding, unity, and location along the needle notch improves the histological yield and~     hence the cancer detection rate3.~      The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows~     physicians to see the prostate gland together with the biopsy sites in a three dimensional~     (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as~     an adjunct to standard of care procedures, to work with standard rectal ultrasound probes,~     and to be incorporated side by side with the techniques currently employed. No change to the~     current employed procedures and techniques is required or suggested. In complementary to the~     Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the~     orientation, unfolding and unity of the sample was developed to increase the pathology~     utility.~      The study objective is to evaluate the contribution of the Navigo™ system, an aiding~     navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection~     ability.~   "
120372|NCT01480362|"~     On behalf of a consortium of 19 health insurance companies the Institute for Research in~     Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and~     conducting a clinical study evaluating the efficacy and effectiveness of negative pressure~     wound therapy in the treatment of wound healing disorders of the foot, which are caused by~     diabetes mellitus.~      This german multicenter study is due to evaluate whether the negative pressure wound therapy~     or the control therapy (standard wound therapy following the guidelines) is superior.~      Patients will be randomly assigned to the two study arms. Both patients and the treatment~     staff know about the specific allocation to the negative pressure wound therapy or standard~     wound therapy arm.~      A photo documentation and a computer-based evaluation of the wound images will be performed.~     This is done centrally by independent examiners, who don`t know neither the patient nor the~     treatment assignment.~      It is believed that the application of the negative pressure wound therapy systems compared~     to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the~     achievement of complete wound closure and that the use of negative pressure wound therapy is~     an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient~     and outpatient care.~      Patient´s to be included into the study should have either a chronic diabetic foot wound~     existing longer than 4 weeks whereas dead tissue components must be completely removed by~     the doctor or a wound after amputation of foot parts.~      The study treatment may have already started in the hospital if applicable. The further~     wound treatment will be mainly performed within outpatient care. Study Participants will~     return to the study centre for regular study visits or even for wound treatment.~      The comparison of the outcomes of both study arms will give valuable information about the~     efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These~     results should be provided until the end of 2016 as a basis for the decision of the Federal~     Joint Committee to answer the question if the negative pressure wound therapy can be~     approved as a standard service for reimbursement by health insurance companies.~   "
120373|NCT01480349|"~     This multicenter, prospective pilot study will compare the effectiveness of two established~     procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight~     infants, specifically ventricular reservoirs and subgaleal shunts. The study is being~     conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to~     conduct multi-institutional clinical trials on pediatric hydrocephalus.~   "
120374|NCT01480336|"~     The purpose of this study is to learn if combination therapy with amiodarone and ranolazine~     (an approved drug for chest pain) can help prevent arrhythmias.~   "
120375|NCT01480323|"~     The current clinical trial shall clarify a synergistic effect with regards to efficiency by~     the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous~     application of ipilimumab.~   "
120376|NCT01480310|"~     This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose~     (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single~     study site in Canada.~   "
120377|NCT01480297|"~     This 12 week study will examine the effects of daily Salsalate treatment on markers of~     neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people~     with type 1 diabetes with signs and symptoms of peripheral neuropathy.~   "
120378|NCT01480284|"~     The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered~     once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis~     B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to~     ETV will be verified using the antiviral effect as the index.~   "
120379|NCT01480271|"~     GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of~     preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis~     factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic~     (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe~     doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes~     in the nasal milieu, for use in subsequent clinical drug development studies. There will be~     two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part~     1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.~   "
120380|NCT01480258|"~     This study will determine whether subjects who receive V419 at 2, 4, and 11 to 12 months of~     age have an acceptable response to the vaccine. this study will also determine whether the~     immune response to V419 is similar to that of subjects who received a licensed vaccine~     control.~   "
120381|NCT01480245|"~     The purpose of this study is to explore long-term safety, tolerability and efficacy of~     GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.~   "
120382|NCT01480232|"~     This study is designed to evaluate the initial evidence for efficacy of the investigational~     medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper~     of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers~   "
120383|NCT01480219|"~     The primary objective of the study is to assess the relationship (both crude and adjusted)~     between voriconazole utilization and the development of non-melanoma skin cancer among adult~     patients who received a lung or heart/lung transplant and were continuously enrolled in a~     large U.S. commercial health plan.~   "
120384|NCT01480206|"~     As endovascular procedures become more complex, there is a growing need for 3D image overlay~     to assist with device guidance and placement. Currently, a 3D image is typically created~     intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D~     image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic~     3D Roadmapping). Philips Healthcare multimodality overlay products allows registration of a~     pre-acquired MR/CT or 3D rotational image to live fluoroscopy.~   "
120385|NCT01480193|"~     Tinnitus is a common problem for which there is no universally effective treatment. The best~     available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but~     only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only~     formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of~     tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans~     received a disability award for their tinnitus amounting to a total annual compensation~     amount of over $345.5 million. Individuals with persistent severe tinnitus are unable to~     habituate to the tinnitus sound that most likely originates in the central auditory system~     (CAS) in response to peripheral injury. In a widely referenced study, it has been~     hypothesized that lack of habituation is secondary to abnormal processing of sensory~     information. Specifically, processing by the limbic system and autonomic nervous system is~     apparently abnormal in patients with increased levels of cortical arousal and inadequate~     coping mechanisms. In otolaryngology and audiology clinics, 'sound-based and educational~     therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input~     to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment,~     additional treatment options are necessary particularly for those with significant~     non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life)~     as well as for those who do not experience significant improvement with SBE. Furthermore,~     commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year~     to become effective and may not be used in patients with hearing that is too poor to be~     modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment~     and the known percentage who do not respond to commonly used therapies, we estimate that 1.2~     million individuals are not able to benefit at all from current, widely used treatment~     strategies. A new strategy to augment those currently used could empower patients to exert~     control over their tinnitus symptoms without the use of medications, expensive devices such~     as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be~     useful both for patients who are not candidates for SBE and for those who respond poorly. An~     Integrative Medicine approach provides a likely solution. To date, there has been no~     systematic study of the benefits of an Integrative Medicine approach for severe tinnitus,~     particularly for non-auditory aspects of tinnitus symptoms. The goal of the proposed study~     is to determine if an integrative medicine approach which targets treatment of the~     nonauditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms~     when added to current commonly applied SBE therapies, compared with SBE alone. If~     successful, this approach will be applied to a larger patient population in future studies~     to test the generalizability and the durability of the effect. Our eventual goal is to~     develop a streamlined approach that individualizes tinnitus treatment based on symptoms and~     patient characteristics, and that can be widely applied in general medical practice.~   "
120388|NCT01480154|"~     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206~     together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma,~     prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells.~   "
120389|NCT01480141|"~     This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will~     have surgery to remove the tumor. The main purpose of this study is to study how safe and~     suitable treatment with Afatinib is in participants before surgery to remove the tumor.~     Another goal of the study is to see if treatment with Afatinib affects the growth and~     activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug~     Administration) and is experimental.~      In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth~     Factor (EGF). This is a protein found in the body which binds to the cell wall to sites~     called receptors and stimulates cell growth. Some cells have too many receptors and~     uncontrolled growth and because of this, develop into a cancer tumor. There are several~     other cancer drugs that bind to these receptors to slow or stop cancer growth such as~     Gefitinib and erlotinib which are FDA approved and used for the treatment of NSCLC.~      The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may~     be a candidate for the treatment of NSCLC and a variety of early stage cancers. Participants~     in this study will take Afatinib by mouth, in pill form, for at least 14 days before having~     their scheduled surgery to remove their cancer tumor. Participants will be observed for side~     effects and followed for 30 days after surgery to assess the results after surgery.~   "
120390|NCT01480128|"~     This clinical trial is going to compare the single-port and multi-port laparoscopic~     colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.~      The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to~     multiport laparoscopic colectomy.~   "
120391|NCT01480115|"~     The ultrasound unit in Meir Medical Center developed new software to automated ovarian~     follicle count on the basis of 3D US. The investigators intent to evaluate this software at~     two steps:~        -  To compared the abilities of the software to physician follicle count.~        -  To evaluate with the software the antral follicle count, as expression to ovarian~          reserve at 3 different time of the month.~      The investigators believe that the software measurement of the small follicle can be better~     than the common antral follicle count that is use today, and by this accurate evaluation of~     the small follicle the investigators can evaluate the ovarian reserve at any time of the~     mount, and not only at the early follicular phase that use today.~   "
120392|NCT01480102|"~     This study will compare post-operative pain levels in patients who receive paravertebral~     block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive~     the block. We hypothesize that patients who receive the block will have lower post-operative~     pain scores and require less narcotics.~   "
120393|NCT01480089|"~     The purpose of this trial is to determine the effect of spraying a local anesthetic called~     Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a~     local anesthetic used to block pain in the body. There are studies showing that Ropivacaine~     decreases the pain of surgery with minimally invasive (laparoscopic) appendix and~     gallbladder removal but has not been tried in robotic pelvic surgery.~   "
120394|NCT01480076|"~     The primary objective of the study is to assess the effect of long-term treatment with~     prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale~     (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment~     responders. The secondary objectives of this study are to compare the change in the PCS of~     the SF-36 between treatment responders and non-responders, to evaluate change from baseline~     in additional quality of life measures among treatment responders as well as changes from~     baseline in treatment responders versus non-responders and to assess the safety and~     tolerability of prolonged-release fampridine 10 mg twice daily.~   "
120395|NCT01480063|"~     The primary objective of the study is to collect additional safety data including the~     incidence rate of seizure and other specific Adverse Events (AEs) of interest from~     participants taking Fampyra in routine clinical practice. The secondary objectives of this~     study are to characterize utilization patterns of Fampyra in routine clinical practice, to~     assess the effectiveness of risk minimization measures as described in the risk management~     plan for Fampyra, to assess the change over time in participant self-reported evaluation of~     the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to~     assess the change over time in physician assessment of walking ability in participants~     taking Fampyra (MS participants only).~   "
120396|NCT01480050|"~     RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~      PURPOSE: This phase I trial is studying the best dose of mibefradil dihydrochloride when~     given together with temozolomide in treating patients with glioma.~   "
120429|NCT01479621|"~     This is a randomized, double-blind, placebo- and open-label active controlled,~     parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and~     older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary~     objective of this study is to evaluate the dose response, efficacy and safety of 4 different~     doses of fluticasone propionate (dose 1, dose 2, dose 3, and dose 4) delivered as~     Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.~   "
120444|NCT01479426|"~     Korea red ginseng has been used in maintaining vitality throughout the globally and~     metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied.~     KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an~     international study on contries other than Korean was performed. In the present study,~     subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG~     will be give daily, and placebo will be give as control. Outcomes including libido,~     erection, sexual activity, and sexual satisfaction will be measured.~   "
120397|NCT01480037|"~     The present study proposes the characterization of sleep patterns of healthy young adults,~     elderly individuals and individuals above 85 years old, using polysomnographic recordings,~     in order to clarify the importance of sleep in longevity. Furthermore, this study intends to~     analyze the oxidative stress-related gene expression in peripheral blood of the three~     studied groups, using the Superarray - RT2 Profiler PCR Array System. After the~     identification of genes whose expression pattern among groups suggest a more specific role~     in longevity, the mechanisms of gene expression regulation, including DNA methylation~     patterns and microRNA expression, as well as the possible genomic sources of variation in~     these genes will be investigated. In addition, the oldest individual (105 years-old) will~     have his whole genome sequenced using next-generation sequencing technology, in order to~     identify rare variants associated with longevity. Subsequently, the effect of the~     polymorphisms and rare variants identified will be confirmed in an expanded sample~     constituted of individuals with various age-ranges. The study will provide a better~     characterization of molecular and physiological mechanisms involved in longevity, hoping to~     contribute to the development of more advanced clinical tools, capable to offer a better~     quality of life for the elderly.~   "
120398|NCT01480024|"~     The investigators will test the hypothesis that obese women have a unique oocyte gene~     expression profile that differs significantly from that of normal weight women.~   "
120399|NCT01480011|"~     Patients with various malignancies who are taken up for high dose chemotherapy followed by~     stem cell transplant (blood and marrow transplant) have very high chances of developing~     severe oral mucositis (between 95-100%). This mucositis not only causes significant~     morbidity but also hampers quality of life so much so that patients at times feel difficult~     to continue treatment.~      No definite treatment exists for prevention or treatment of oral mucositis in this group of~     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth~     factor) will reduce duration and severity. Palifermin is very expensive and not available in~     country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD~     2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and~     neck squamous cell cancer patients. (Published online in European Journal of Cancer:~     http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported~     with its use.~      Now, the investigators want to study the efficacy of this drug to reduce severity of~     mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be~     supplied by CD Pharma India Private Limited.~      The investigators further give undertaking that study will be carried as per good clinical~     practices (GCP) and declaration of Helsinki.~   "
120400|NCT01479998|"~     Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling~     sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency~     management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive~     reinforcers)~   "
120401|NCT01479985|"~     The purpose of this study is to conduct a randomized clinical trial of a web-based~     contraceptive decision aid compared to routine contraceptive counseling to evaluate the~     effect of the contraceptive decision aid on the contraceptive method selected by the~     participant.~      The investigators primary hypothesis is that women utilizing a computerized Contraceptive~     Decision Aid (CDA) will be more likely to choose highly effective contraception than women~     who undergo standard clinical contraceptive counseling.~   "
120402|NCT01479972|"~     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing~     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against~     tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.~     The new vaccine should be at least as potent as the current strain and should be safer than~     BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised~     bacteria to be re-suspended before intradermal injection. The preceding clinical trials in~     80 volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated~     immunogenicity and safety being sufficient for proceeding with the clinical development in~     newborn infants. Hence, the current study is commenced at Stellenbosch University, South~     Africa. This is the first investigation of VPM1002 in newborn infants.~   "
120403|NCT01479959|"~     Adequate communication is a major part of the quality of life of tracheostomized ventilator~     dependent patients. Maintaining speech is therefore major goal in the management of these~     patients.~      The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the~     improvement of speech. The best level for speech may vary from one patient to the other The~     purpose of this study is to determine individually the most efficient PEEP level in terms of~     speech while obtaining the most secure condition and the best possible respiratory~     tolerance. In order to improve the latter, the investigators will use a device which allows~     the patients to control the activation of PEEP so that they can use it only when needed~     (i.e. when they wish to speak). The investigators will compare the effect of different PEEP~     level to try to determine the best compromise to improve speech in tracheostomized~     ventilator-dependent patients.~   "
120404|NCT01479946|"~     Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment~     for breast cancer that has spread to skin. In routine clinical practise, ECT is offered to~     patients when all other treatment options have been exhausted. This study tests the~     hypothesis that early treatment with ECT may result in improved local control of skin~     metastases, improved quality of life and reduced health care costs. Patients are randomised~     to either ECT given as early as possible in the course of the disease or delaying ECT for at~     least 6 months.~   "
120441|NCT01479465|"~     This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in~     combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in~     participants with metastatic KRAS mutant colorectal cancer.~   "
120442|NCT01479452|"~     The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of~     bariatric surgery on overall mortality and obesity-related co-morbidities.~   "
120443|NCT01479439|"~     Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney~     disease and renal failure in nearly one third of patients with sickle cell disease.~     Currently, there is no treatment for sickle cell related kidney disease.~   "
120457|NCT01479244|"~     Purpose of this trial:~        1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine®~          (sargramostim, GM-CSF).~        2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control~          subjects.~   "
120405|NCT01479933|"~     Vitamin D deficiency is widespread throughout the world, and the deficiency has been~     associated with several chronic diseases, such as cardiovascular diseases and diabetes. In~     Nordic countries, like in Finland, there is a particular variation in vitamin D status, and~     during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum~     concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men~     and one third of women also have some degree of impairment of glucose metabolism.~      The purpose of this trial is to investigate the effects of two different daily doses of~     vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D~     deficient, have a high body mass index and at least two characteristics of cardio-metabolic~     syndrome.~      Altogether 102 subjects with low serum calcidiol (<60 nmol/L) will be recruited and~     randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3)~     placebo. The supplementation period will last for 6 months from September 2011 to March~     2012.~      The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose~     and insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent~     manner. (2.) Vitamin D supplementation will have an effect on the expression of genes~     involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation~     will have an effect on epigenetic changes in key genes participating in vitamin D~     metabolism.~   "
120406|NCT01479920|"~     This is a randomized, assessor-blind, placebo controlled study in major depressive disorder~     (MDD) patients. Subjects receiving antidepressant drug (FLX) would be assigned to receive~     either 18 sham / active DCEAS for in 6 weeks. Changes in the severity of depressive symptoms~     over time are measured using depression rating scales. Brain glucose metabolic levels are~     measured using PET at baseline and endpoint. The most intriguing and expected result might~     be that acupuncture treated-patients may display comparable or even better outcomes and the~     clinical improvements by acupuncture are correlated with the restoration of the activities~     in the related brain regions.~   "
120407|NCT01479907|"~     The aim of this double-blinded prospective randomised trial is to explore the potential~     benefits of early postoperative administration of Synbiotics (combination of prebiotics and~     probiotics) to patients who have undergone colectomy for cancer. The patients are randomised~     to either synbiotics or placebo administration at the day they are able to tolerate po~     liquid diet and for 15 days thereafter.~      Primary end points of the study will be:~      Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months~     postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of~     Life Index)~      Secondary end points will be:~      -Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months~     postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30~   "
120408|NCT01479894|"~     This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the~     distribution of Recurrence Score® and gene groups of stage II colon cancer in African~     American (AA) and Caucasian individuals. Other covariant factors in the medical chart will~     be analyzed as well. Three institutions will contribute patients to this study with a total~     patient number goal of approximately 200 with approximately 100 being AA and approximately~     100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be~     matched for every African American enrolled.~   "
120409|NCT01479881|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 (administered once a day) on the single-dose pharmacokinetics of the~     immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and~     tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore~     potentially be coadministered with TMC435 in patients infected with hepatitis C virus that~     undergo liver transplantation. We will also explore the short-term safety and tolerability~     following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus~     after single dosing in healthy participants. Steady-state is a term that means that the drug~     has been given long enough so that the plasma concentrations will remain the same with each~     subsequent dose. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
120410|NCT01479868|"~     The purpose of this study is to evaluate the safety and tolerability of TMC435 along with~     pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C~     virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1,~     and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks~     after the planned end of treatment.~   "
120411|NCT01479855|"~     The purpose of the study is to compare the concentrations of Vitamin B1 (thiamine), Vitamin~     B6 (pyridoxal-5-phosphate), folate, Vitamin B12 (cobalamin), Vitamin C (ascorbic acid),~     Vitamin A (retinol), Vitamin E (alfa-tocopherol), homocystein, uric acid, F2~     8-α-isoprostane, 8-deoxyguanosine, retinoids, tau-protein and β-amyloid in spinal fluid,~     metabolomics, proteomics, m-RNA for DNA repair enzymes and DNA in patients who suffer from~     mild cognitive impairment (MCI) or mild dementia of Alzheimers type, with healthy controls.~      A second aim is to explore the association between vitamin and nutrient reductions, if any,~     and cognitive function as well as vascular score and possible changes in the MRI.~   "
120412|NCT01479842|"~     This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when~     given together with rituximab and bendamustine hydrochloride in treating patients with~     recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and~     bendamustine hydrochloride may kill more cancer cells.~   "
120413|NCT01479829|"~     This project will attempt to enhance and augment the antidepressant efficacy of a commonly~     used antidepressant in poorly responding bipolar depressed patients.~   "
120414|NCT01479816|"~     This study will analyse existing data to establish a clinically useful index to predict~     those women who are more likely to become incontinent. This would create significant~     opportunities for focused prevention and early intervention strategies.~   "
120415|NCT01479803|"~     The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for~     the diagnostic of solid pancreatic masses is 70% on average in the current literature with~     22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%).~     In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis~     is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo~     endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE~     Mark in the field of EUS. This instrument combines the comfortable and handy size of 22~     Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core~     biopsy. In addition, a single pass through the tumor is achieved with this hand against~     several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue~     material more abundant during the sampling, without increasing morbidity and increase the~     diagnostic accuracy. A preliminary prospective study with this material has shown~     interesting results (increase the diagnostic accuracy of 15%).~      To determine the diagnostic gain with this new hand, it seemed essential to propose a~     prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge)~     randomized (randomization of the order of the needles) in crossover (on the same lesion) in~     samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for~     punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles~     on the same injury can limit the effect of variability between patients and thereby have a~     better power for the investigators study without increasing the risk of complications (the~     needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic~     solid tumors is one that poses the biggest diagnostic problem still present in the~     investigators daily practice. The aim of this study is to compare the diagnostic accuracy of~     the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for~     pancreatic solid tumors under EUS.~   "
120416|NCT01479790|"~     Dry eye is a common condition that affects vision and quality of life in patients. Dry eye~     clinical research is limited to follow up of disease progression. Currently, most research~     outcomes are based on subjective patient complaints rather than objective assessment of the~     condition. Only few objective measurements for dry eye are available today and this is~     mainly the result of poor repeatability and inaccuracy.~      This current study aims to evaluate 2 new non-invasive imaging techniques suitable for dry~     eye assessment.~      Anterior segment optical coherence tomography (AS-OCT) is an imaging device that has the~     ability to image the tear meniscus of the eye in a safe and non-invasive manner. Image~     analysis can then indirectly determine the tear film volume. Improvements in the image~     resolution of these devices require a study that compares the repeatability and agreement of~     an older (Visante AS-OCT) and a newer instrument (Cirrus AS-OCT) which the current study~     aims to address.~      Another method of evaluating dry eye disease is a novel technique that uses functional~     infrared thermography to measure tear evaporation rate. This study will also establish~     repeatability of measurements of the ocular surface temperature which are used to calculate~     tear evaporation rates.~      Should these methods are found to be repeatable, they can be used in future clinical trials~     as an additional tool to investigate dry eye treatments.~   "
120417|NCT01479777|"~     The research is being done to find out if Functional Electrical Stimulation (FES) stepping~     can improve the function of people with spinal cord injury that paralyzes.~   "
120418|NCT01479764|"~     This study will compare the incidence of residual neuromuscular blockade in participants who~     undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo~     reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).~   "
120419|NCT01479751|"~     In this study, methods which are known for facilitating rapid sequence intubation or~     accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine~     pretreatment, large dose rocuronium and priming.~   "
120420|NCT01479738|"~     The capitate had a widened distal base. The distal articulation can be used for proximal~     interphalangeal (PIP) articula reconstruction.~   "
120421|NCT01479725|"~     To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial~     cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the~     non-ulcerative patients with interstitial cystitis.~   "
120422|NCT01479712|"~     The purpose of this study is to determine if intra-abdominal irrigation at the time of~     cesarean delivery increased maternal GI discomfort without affecting infection rates.~      We hypothesized that avoiding intra-operative irrigation at the time of cesarean delivery~     will decrease intra-operative nausea and vomiting without increasing maternal infectious~     morbidity, post-operative pain, return of bowel function, or time to discharge.~   "
120423|NCT01479699|"~     The purpose of this study is to determine how olive leaf is absorbed and metabolised and~     also whether it has any effect on the elasticity of blood vessels and the immune system.~   "
120424|NCT01479686|"~     Many clinical studies have been reported on iMRI, however, their evidence levels are~     relatively not as good as what people hope they will be. Based on the available literature,~     there is, at best, level 2 evidence that iMRI-guided surgery is more effective than~     conventional neuronavigation-guided surgery.~      The investigators aim to do a single center prospective randomized triple-blind controlled~     clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma~     resection on surgical efficiency and progression-free survival of malignant glioma to~     provide a level 2A evidence for its clinical application.~   "
120425|NCT01479673|"~     The aim of this study is to perform a prospective, randomized, controlled blinded study in~     critically patients to assess the necessity for measuring daily resting energy expenditure~     as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce~     the rate of new infections.~      Study Design :Multi-center, randomized, single blinded, controlled study. Study Population:~     newly-admitted, adult mechanically ventilated ICU patients.~   "
120426|NCT01479660|"~     Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered~     mucosal immune response to luminal bacterial antigens. Current research suggests that an~     inappropriate and persistent immune response against commensal intestinal bacterial flora~     plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has~     been also proposed that the signs and symptoms of IBD may be mediated by the increased~     intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased~     intestinal permeability results in further exposure of underlying intestinal mucosa to~     luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring~     intestinal permeability rather than only reduction of mucosal inflammation would thus be a~     desirable endpoint in the restoration of mucosal integrity and would be the harbinger of~     better long term outcome. Many clinical trials have shown that probiotics may have~     beneficial effect on IBD patients. Probiotics are hypothesized to work by several mechanisms~     though they are not clearly established. The role of probiotics in improving intestinal~     permeability has not been evaluated. The probiotic VSL #3 is easily available, cheap,~     effective and safe alternative or substitute for the existing therapeutic agents will be~     evaluated in this study for their efficacy, tolerability, compliance in inducing clinical~     response in patients with Ulcerative colitis. This will be a double blind randomized placebo~     controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3)~     in patients with inflammatory bowel disease. The objectives of this study are to determine~     the efficacy of probiotics on clinical endoscopic and histological improvement, to find the~     improvement in faecal, serum and intestinal tissue inflammatory markers, improvement in~     intestinal permeability, improvement in Quality of life parameters.~   "
120430|NCT01479608|"~     Colorectal liver metastases (CLM) are currently considered an absolute contraindication for~     liver transplantation (Lt) although Lt for other primary and secondary liver malignancies~     show excellent outcome in selected patients. Before 1995, several Lts for CLM were~     performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since~     then, several advances have been achieved and survival following Lt has improved by almost~     30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.~      The investigators have previously included 21 patients in a pilot study. All patients had~     advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously~     reported outcome for this patient group and is comparable or better than survival following~     repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further~     improve the results.~      The investigators will conduct a randomized controlled trial to explore whether liver~     transplantation in selected patients with liver metastases from CRC can obtain significant~     life extension and better health related quality of life compared to patients receiving~     surgical resection.~      The investigators will also explore if patient selection according to nomo-grams for outcome~     of colorectal cancer can define a subgroup of patients with a 5 year survival of at least~     50% or even cure from the disease.~   "
120431|NCT01479595|"~     This study is designed to investigate the efficacy and safety of QBX258 in subjects with~     moderate to severe asthma.~   "
120432|NCT01479582|"~     Background:~      - Cord blood banks have been set up to collect and store umbilical cord blood for~     transplants. These transplants are used to treat different types of cancer. In October 2011,~     the Food and Drug Administration (FDA) began considering cord blood as a biological drug.~     Most of the cord blood units currently available in cord blood banks in the United States~     and other countries were collected before the FDA set these new standards. The units meet~     standards set by the National Marrow Donor Program (NMDP), but they were not collected,~     tested, or stored exactly according to FDA standards. As a result, the new guidelines state~     that they may only be used for transplant if the transplant is done as part of a study.~     Researchers have set up a study to provide these cord blood units to recipients and to study~     the effects of their use.~      Objectives:~        -  To provide access to cord blood units for recipients whose best choice for a unit meets~          NMDP but not FDA standards.~        -  To study the effects of these cord blood transplants.~      Eligibility:~      - Individuals who need to have a cord blood transplant to treat certain types of cancer.~      Design:~        -  Participants will be screened with a physical exam, medical history. They will also~          have blood tests and imaging studies.~        -  Participants will have the cord blood transplant and allow their medical data to be~          collected by the study researchers.~   "
120433|NCT01479569|"~     Background:~      - Pericardiocentesis uses a needle and small tube to drain fluid from space around the~     heart. The most common reason to perform this procedure is that the fluid is interfering~     with heart function. This procedure is usually guided by X-rays. However, researchers want~     to try the procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance~     may be more precise than X-rays, which can make the procedure easier and more effective.~      Objectives:~      - To test whether MRI guidance can improve pericardiocentesis.~      Eligibility:~      - Individuals at least 18 years of age who need to have pericardiocentesis.~      Design:~        -  Participants will have a physical exam before the procedure. Blood samples will be~          taken.~        -  The pericardiocentesis will be performed using MRI guidance. The procedure may take up~          to 2 hours.~        -  If for some reason the MRI guidance is not successful, participants will have the~          regular X-ray procedure. The MRI system will be used to take high-quality pictures~          afterward to check the results.~   "
120434|NCT01479556|"~     This study is a phase IV clinical trial with the objective of evaluating whether pain relief~     associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more~     efficient during the early rather than late subacute phase of spinal cord injury.~   "
120435|NCT01479543|"~     The present report describes the design of a clinical trial performed on healthy adult~     individuals to check whether the daily intake of the new Hero strains contribute to~     intestinal colonization, under safe and tolerable conditions, with a positive contribution~     to health and wellbeing of healthy individuals.~      Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036),~     increases intestinal microbiota in healthy adults, being safe and well tolerated. The~     regular intake has positive effects on the gastrointestinal and immune system.~   "
120436|NCT01479530|"~     The rationale for conducting this study is to evaluate the efficacy, tolerability, and~     safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD)~     Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the~     treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with~     levodopa) in patients with end of dose fluctuations.~   "
120437|NCT01479517|"~     The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for~     unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary~     teeth for dental procedures.~   "
120438|NCT01479504|"~     This study is a multicenter trial.The primary objective is to estimate short-term efficacy~     and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant~     chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin~     to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in~     concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal~     carcinoma.~      Secondary objectives are to evaluate the overall survival, the distant metastases free~     survival, and disease free survival of patients with locoregionally advanced nasopharyngeal~     carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the~     regimens.~   "
120439|NCT01479491|"~     This study aims to analyse baseline data on IS in order to monitor the possibility of~     increased risk of IS in children aged <12 months after introduction of the Rotarix~     vaccination in Japan.~   "
120440|NCT01479478|"~     The investigators wish to determine if oral probiotic supplementation during the second half~     of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational~     age, thereby decreasing need for maternal antibiotic administration at time of labor. The~     importance of this study is that it may offer a safer alternative to antibiotic treatment of~     group B Streptococcus (GBS) colonized pregnant women.~   "
120445|NCT01479413|"~     The investigators will investigate~        1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria~          DNA copy numbers and the clinical psychopathology of schizophrenia, including severity~          of positive and negative symptoms, obesity and metabolic syndrome.~        2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism~          of D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and~          clinical phenotypes in Taiwanese populations.~        3. whether these biological markers could be as clinical markers in schizophrenia for a~          long-term follow-up study.~   "
120446|NCT01479400|"~     The primary aim of this prospective study is to evaluate the effect of antipsychotics on~     infant development especially neurobehavioral development which evaluated by the Bayley-III~     when mothers are treated with antipsychotics throughout their pregnancy.~   "
120447|NCT01479387|"~     This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in~     Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess~     biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin~     is injected to the patient for the actual treatment. The objective of this study is to~     assess appropriateness and necessity of revision of the standardized criteria for image~     interpretation of In-111 Zevalin by comparing assessment by the investigator and the members~     of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be~     recruited.~   "
120448|NCT01479374|"~     The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic~     solution for the treatment of ocular itching associated with allergic conjunctivitis using~     the Conjunctival Allergen Challenge (CAC) model.~   "
120449|NCT01479361|"~     Background:~      - People who are infected with the human immunodeficiency virus (HIV) are at risk of getting~     certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain~     infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to~     treat HIV and lower the risk of infections. However, some ARV drugs may make other drugs~     used to treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV~     drugs to see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis.~      Objectives:~      - To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of~     atovaquone.~      Eligibility:~        -  Individuals between 18 and 70 years of age who have HIV.~        -  Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV~          drugs.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  This study has a screening visit and five study visits. Two of the study visits will~          last about 12 hours; the other three visits will last about 1 hour each.~        -  Participants will receive either a low dose or high dose of atovaquone to take for 14~          days. They will record doses and any symptoms on a diary card at home.~        -  After 14 days, participants will have a 12-hour visit to provide blood samples. There~          will be a wash-out period with no doses for up to 6 weeks.~        -  After the wash-out period, participants will switch dose levels to either the high or~          low dose.~        -  After 14 days, participants will have a 12-hour visit to provide blood samples.~   "
120450|NCT01479348|"~     Background:~      - The drugs FdCyd (also called 5-fluoro-2'-deoxcytidine) and THU (also called~     tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how~     FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging~     studies to see how the drug reacts with the cancer. This study is not a treatment study. It~     is open only to people who are already on the FdCyd and THU cancer treatment study.~      Objectives:~      - To study how FdCyd affects advanced cancer cells.~      Eligibility:~      - Participants in National Cancer Institute study 09-C-0214.~      Design:~        -  Participants will have two imaging studies, one before starting FdCyd and THU treatment~          and one after starting treatment.~        -  Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The~          doses will be followed by two imaging study scans and frequent blood samples.~        -  This procedure will be repeated at a later date, during the FdCyd and THU treatment~          period.~        -  Treatment will not be provided as part of this study. This is an imaging study protocol~          only....~   "
120451|NCT01479322|"~     Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset~     obesity and endocrine dysfunction that leads to cardiovascular disability and early death~     within the first 3 decades of life.~      Objectives: To assess the significance of risk factors for future disabilities, carotid~     artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic~     risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted~     controls.~   "
120452|NCT01479309|"~     The goal of this clinical research study is to expand the research following finding the~     highest tolerable dose of sodium stibogluconate combined with interferon alfa-2b in the~     treatment of patients with advanced cancer that has not responded to standard treatment or~     where there is no standard treatment for this type of cancer.~   "
120453|NCT01479296|"~     The purpose of this study is to evaluate the immune response to the Vaccine Research Center~     (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways,~     in healthy, HIV-uninfected adults.~   "
120454|NCT01479283|"~     The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever~     international multi-center randomized controlled trial in bone cancer surgery. In order to~     avoid amputation for bone cancer in the leg, complex limb-saving operations are performed.~     However, infections with devastating complications following surgery are common. Surgeons~     from across the world will randomize patients to receive either short- or long-duration~     antibiotic regimens after surgery with the goal of identifying the best regimen to reduce~     these infections.~   "
120455|NCT01479270|"~     The Transversus Abdominal Plane (TAP) block has been used with good success to decrease~     postoperative pain following laparatomy. If the TAP block provides any improvement in the~     quality of recovery following laparoscopic hysterectomy, it could decrease the need for~     postoperative narcotics and allow for more outpatient hysterectomy procedures.~   "
120456|NCT01479257|"~     The goal of this research study is to learn how cultural, environmental, and interpersonal~     experiences, as well as personal thoughts and feelings, influence cancer risk behaviors~     among Latino residents of Houston, Texas.~   "
120460|NCT01479205|"~     One aim of this study was to find out if the bronchial allergen provocation (BAP) is an~     appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The~     investigators had one group of children receiving SIT and one group of patients who denied a~     SIT although they had an indication for it. Retrospectively the investigators analysed the~     data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November~     2008 till February 2010). Prospectively The investigators analysed the lung parameters and~     allergic labor parameters that we got in the course of the second BAP. The investigators~     mean parameter was PD20FEV1-mite. Another aim of The investigators study was to find~     specific immunological differences between children who improved because of SIT and those~     who showed no improvement. Thus, The investigators compared the levels of total IgE,~     cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific~     IgG-mite and specific IgG4-mite after SIT.~   "
120461|NCT01479192|"~     The purpose of this trial is to assess the effect of fenretinide (4-HPR), a vitamin A~     derivative, in reducing the incidence of breast cancer in healthy premenopausal women at~     increased familial/genetic risk for breast cancer~   "
120462|NCT01479179|"~     The goal of Phase 1 of this clinical research study is to test the safety and tolerability~     of AMG 479 when given with trastuzumab.~      The goal of Phase 2 of this clinical research study is to learn if the combination of AMG~     479 and trastuzumab can help to control breast cancer.~      AMG 479 is designed to block tumor cells from growing and spreading.~      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking~     proteins inside the cancer cell.~   "
120463|NCT01479166|"~     In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the~     involvement of small airways (small airway disease - SAD) are to be compared with a~     historical control group matched in age and gender. During the first study visit subjects~     are asked to perform a pulmonary function test (spirometry, body plethysmography with~     helium, determination of Trapped Air) and exhaled nitric oxide (eNO) and exhaled carbon~     monoxide (eCO) measurements will be done in exhaled air. In addition, a blood sample is~     drawn to describe inflammatory status. Sputum is induced as well. During the second study~     visit, a non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.~      The aim of the study is to get a characterization of the bronchial and systemic inflammation~     (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF~     patients with and without the involvement of the small airways, which may point to new~     treatment strategies.~   "
120464|NCT01479153|"~     Central venous catheters are needed in the critical care setting to administer drugs. Three~     sites are available to gain vascular access: subclavian, internal jugular and femoral. Each~     site has complications, but there is no randomized controlled study which compared the 3~     sites.~      The investigators hypothesis is that subclavian catheterization reduces the risk of major~     complications compared to internal jugular or femoral.~   "
120465|NCT01479140|"~     Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD)~     among young women, the majority of these abnormalities were misdiagnosed in this population,~     and thus treatments were not targeted adequately in this patient population. Furthermore,~     the short and long-term cardiovascular outcomes of young women with NACAD have not been~     evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and~     subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to~     further evaluate this population. We propose to evaluate young women (age < or equal to 55)~     presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI~     differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other~     vascular territory, and to evaluate the long-term outcome of young women with NACAD in~     comparison to those with atherosclerotic CAD over a 5-year follow-up.~   "
120466|NCT01479127|"~     To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced~     Parkinson's disease (PD) patients with severe motor complications. The complications of~     medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be~     investigated.~   "
120467|NCT01479114|"~     The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on~     neutrophil production and CD11b expression.~   "
120468|NCT01479101|"~     The scope of this registry study is to measure chemosensitivity as defined by pCR (primary~     endpoint), or endocrine sensitivity as defined by partial response (decrease in longest~     tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for~     neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy),~     metastasis-free survival and relapse-free survival(secondary endpoints) in molecular~     subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint~     profiles in addition to possible novel expression profiles.~   "
120469|NCT01479088|"~     Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label,~     active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet~     HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with~     chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.~   "
120470|NCT01479075|"~     -Insulin has a direct effect on the energy metabolism of the brain under basal conditions~     and has an effect on the hepatic glucose production, lipid metabolism and the secretion of~     various hormone~      The purpose of this study is to determine whether central insulin influences the human~     peripheral insulin sensitivity of liver and muscle~   "
120471|NCT01479062|"~     The trial will test whether the Alive multi-channel delivery health behavior program can~     positively affect weight and glucose level in pre-diabetics.~   "
120472|NCT01479049|"~     The investigators previously investigated the cardioprotective effect of an~     adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric~     cardiac surgery, which was associated with better myocardial protective effects when~     compared with conventional high-potassium cardioplegia. However, this cardioplegia could not~     be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive~     hemodilution and severe systemic hypotension induced by adenosine. Therefore, the~     investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia~     without adenosine could also arrest the heart and have better myocardial protective effects~     compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations~     without excessive hemodilution and systemic hypotension.~   "
120473|NCT01479036|"~     This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and~     epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer~     patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy~     to chemotherapy could further benefit breast cancer patients.~   "
120474|NCT01479023|"~     2.1 Primary Objectives~        1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid~          tumors (Cohort 1 only)~        2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET~          signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled~          U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))~        3. To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)~      2.2 Secondary Objectives~        1. To determine the relationship between U3-1287 serum concentration and HER3 receptor~          occupancy (as measured by PET/CT) in subjects with advanced solid tumors~        2. To measure the tumor response rate as defined by Response Evaluation Criteria in Solid~          Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2~          only)~        3. To characterize the PK exposure of U3 1287 when administered intravenously to patients~          with advanced solid malignancies.~        4. To measure the rate of anti-U3-1287 human antibody development in subjects with~          advanced solid tumors treated with U3 1287 monotherapy~      2.3 Exploratory Objectives~        1. To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance~          imaging (MRI) (Part 2 only)~        2. To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g.,~          proteins and transcripts) that predict response to U3-1287~        3. To obtain tumor samples for DNA extraction for analysis of potential predictors of~          response to U3-1287 and any related genes as suggested by emerging data~   "
120475|NCT01479010|"~     This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1~     blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo~     cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra~     (recombinant human Interleukin-1 receptor antagonist.~   "
120476|NCT01478997|"~     This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving~     symptoms of Moderate Osteoarthritis of the Knee.~   "
120477|NCT01478984|"~     Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive~     strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for~     recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI~     according to current guidelines presenting with multivessel disease. We will exclude~     patients with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite~     drug therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery~     bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass~     surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success~     was defined as the achievement of an angiographic residual stenosis of less than 30% and a~     thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.~      Patients randomized to One-Stage group were completely revascularizated in one time PCI,~     whereas patients randomized to Multi-Staged group were completely revascularizated in more~     time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of~     600 mg before the PCI (for loading dose administered more than 6 h prior to procedure).~     Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and~     clopidogrel 75 mg/day for at least one month.~   "
120478|NCT01478971|"~     The purpose of this study is to understand the effects of a dialysis center switching its~     dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and~     other parameters.~   "
120479|NCT01478958|"~     It is well established that diet plays an important role in both the development and~     progression of heart disease. Different types of dietary fat have varying effects on heart~     disease risk factors. The elasticity of an individual's blood vessels is strongly associated~     with heart disease risk and recent evidence suggests that dietary manipulation may influence~     elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and~     polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence~     exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and~     rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in~     vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels.~     However, the influence of these dietary fats on the elasticity of blood vessels remains~     unclear.The main purpose of the DIVAS study is to determine the effects of the substitution~     of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel~     elasticity and to determine the effects of these different dietary fats on other risk~     factors for heart disease including lipoproteins and inflammatory biomarkers.~   "
120480|NCT01478945|"~     This study is a small pilot randomised controlled trial (RCT) comparing hand-held NB-UVB~     light devices with placebo devices. These devices will be used by the participants to treat~     their vitiligo at home for a period of four months. The main purpose of the trial is to~     provide feasibility data that can be used to inform the design of a future multi-centre RCT~     of these devices. Two hand-held UVB devices with similar manual operating system are being~     tested during this pilot study. This trial will help the investigators to establish which~     device is likely to be best for the main trial.~      Participants will be approached in a variety of ways (through secondary care, primary care~     and through direct advertising). Potential participants who contact the co-ordinating centre~     expressing an interest in the trial will be given more information about the trial, checked~     for preliminary eligibility, and sent an appointment for a screening visit at the closest~     recruiting hospital (Nottingham or Leicester).~      This screening visit will be conducted by a research nurse, but a dermatologist will also be~     present in order to confirm the diagnosis of vitiligo and to confirm the participant's~     suitability for UVB treatment at home. If eligible and willing to take part in the trial,~     participants will provide written informed consent and baseline data will be collected. In~     order to define the starting dose to be used when treating the vitiligo, a minimum erythema~     dose (MED) test will be conducted.~      An educational session will be provided by the research nurse outlining how to use the~     devices, how to assess side-effects of the treatment and how to complete the treatment~     diary. It is anticipated that the screening visit and educational session will take place on~     the same day and may take up to 1.5 hours.~      On the following day, a brief visit to the hospital will be required in order to examine the~     skin and read the MED results (if more convenient, the educational session may be delivered~     at this time). Once this has been done, participants will be given the devices to use at~     home - treatment is applied 3 times per week on alternate days. They will be followed up by~     telephone at week 1, week 2 and week 12 - in order to provide support and to monitor~     side-effects. Participants will be asked to keep a treatment diary that records when the~     treatment has been used and records side-effects experienced. Emergency contact details will~     be provided in case of urgent medical need.~      Participants will continue with treatment at home for the 16-week trial period. Two further~     hospital visits will take place in order to record outcome data~   "
120576|NCT01477697|"~     This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation~     in trauma patients. The main hypothesis is that such supplementation will reduce the~     presence of biomarkers of systemic inflammation, as compared to placebo~   "
120481|NCT01478932|"~     The purpose of this study is to provide information on how the practicing of diaphragmatic~     breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage~     heart failure patients to engage in health-promoting activities by successfully controlling~     their shortness of breath (dyspnea).~   "
120482|NCT01478919|"~     Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer.~     Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after~     conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue.~     Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the~     risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other~     modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and~     surgical treatment, could be considered. The purpose of this prospective study is to~     identify risk factors associated with the presence of LRN after CER of LSTs.~   "
120483|NCT01478906|"~     The current study is designed to investigate the difference of plasma orexin A levels~     between elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who~     will undergo elective lumbar surgery.~   "
120484|NCT01478893|"~     The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068.~     Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and~     smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be~     evaluated.~   "
120485|NCT01478880|"~     First clinical studies indicate an effect of repetitive transcranial magnetic~     stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size,~     optimal stimulation site and parameters are unclear. With this randomized,~     placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous~     theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The~     treatment will be applied add-on to individual antipsychotic and behavioral therapy.~     Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway~     between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a~     sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.~   "
120486|NCT01478867|"~     The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by~     assessment of gliadin 33-mer equivalent epitopes in feces.~   "
120487|NCT01478854|"~     The long term goal of this research is to establish whether NPC sparing RT techniques~     improve neurocognitive outcomes compared to conventional RT for brain tumors. If the~     proposed study demonstrates that NPC sparing RT is not associated with increased LR in the~     spared regions of the brain compared to conventional RT, it will ideally serve as the~     foundation for a future multi-institutional randomized controlled trial comparing~     neurocognitive outcomes in patients treated with NPC-sparing RT versus conventional~     radiation therapy.~   "
120488|NCT01478841|"~     Diet and nutrition play an essential role in the development and the clinical expression of~     the most common health problems. Overeating and obesity induce oxidative stress, which has~     been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes~     (T2D) and associated cardiovascular complications. The main objective of the proposed~     research is to evaluate the beneficial effects of polyphenolic compounds derived from red~     grape marc extracts on the cascade of events leading from overeating to oxidative stress and~     insulin resistance. For that, we will study free radicals production, inflammatory markers,~     adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in~     healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D~     patients with associated overweight). These volunteers will be randomized between a placebo~     and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of~     polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.~   "
120489|NCT01478828|"~     To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc~     myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens~     in intermediate-/high-risk localized prostate cancer patients.~   "
120490|NCT01478815|"~     Contingency management is efficacious for treating cocaine abuse, but contingency management~     interventions have rarely been applied to patients with severe and persistent mental health~     problems. This pilot project will estimate effect sizes of contingency management for~     reducing cocaine use in patients receiving psychiatric care at a large community based~     mental health program. In total, 30 cocaine abusing patients will be randomized to one of~     two 8-week treatment conditions: standard care or standard care with contingency management.~     Patients in both conditions will provide breath and urine samples for toxicology testing~     twice per week. In the contingency management condition, patients will receive the~     opportunity to win prizes for submitting cocaine negative urine samples. The investigators~     expect that patients receiving contingency management will evidence reductions in cocaine~     use and may show improvements in psychiatric symptoms and psychosocial functioning relative~     to patients in standard care. Effect size estimates obtained from this study will be used to~     guide larger scale and longer duration evaluations of contingency management for dually~     diagnosed patients.~   "
120491|NCT01478802|"~     Based on recent two-center results (Eur Respir J. 2011 Sep 1. [Epub ahead of print] PMID:~     21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with~     Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of~     patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).~      Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the~     intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96~     hours (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises~     to >200 mmHg for >12 hours), followed by return to lung protective conventional mechanical~     ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10~     postrandomization, patients will be returned to HFO upon recurrence of their~     moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive~     lung protective CMV.~   "
120492|NCT01478789|"~     The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering~     of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol~     esters (PS-ester), consumed within dairy products.~   "
120493|NCT01478776|"~     The aim of this study is the comparison between the effects of supplementation with omega-3~     or placebo for 10 weeks in type 2 diabetics~   "
120495|NCT01478750|"~     Interaction of fat with the mouth, stomach and intestine will trigger physiological~     responses that will impact on the digestion, gut transit time and absorption of fat. These~     responses will also influence and contribute to regulation of food intake and satiety. No~     systematic research on understanding how the physiological-chemical properties of food~     affect the digestion and absorption of lipids has been carried out previously. Studies have~     shown that the release of free fatty acids triggers the fat-related responses. The~     investigators hypothesize that the release of fatty acids depends on the colloidal state of~     the fat, which changes progressively due to the pH changes and enzyme activities in the~     mouth, stomach and intestine.~   "
120496|NCT01478737|"~     To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous~     hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic~     retinopathy (PDRP).~   "
120497|NCT01478724|"~     Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and~     microarchitectural deterioration of bone tissue, with a consequent increase in bone~     fragility and susceptibility to fracture. Osteoporosis is a serious public health problem~     that is responsible for approximately 3 million women with osteoporosis in France, with~     approximately 150,000 cases per year occurring in vertebral fractures, of which only one~     third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The~     frequency of the disease increases with age, particularly among women: 10% among women aged~     60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen~     deficiency causes alterations of the immune system, decreased bone formation,~     microarchitectural deterioration and a decrease in bone mass. Various factors may contribute~     to this decrease in bone density such as diet, lifestyle, or the genetic background.~      According to prospective studies, an overexpression of 135% of hip fractures is expected at~     European level in 50 years. Therefore, it is interesting to develop new prevention~     approaches aimed at maintaining the healthy aging population. Nutritional researches can~     consider setting up a real prevention.~      Studies suggest that specific milk protein fraction contain factors able to promote bone~     formation, inhibit bone resorption in vitro. In animal model, they showed that the specific~     fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption.~     Furthermore, in human volunteers, a supplementation with the specific milk protein fraction~     maintains balanced bone remodelling and increase bone mineral density. For example, in~     healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in~     the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).~      The objective of this study is to assess the efficacy of daily consumption of the milk~     proteins fraction on bone mineral density improvement in healthy postmenopausal women.~   "
120498|NCT01478711|"~     This study will use a rules-based expert system embedded in an electronic health record~     (EHR) to extract, interpret, and present salient facts and recommendations related to the~     healthcare of premature infants.~   "
120499|NCT01478698|"~     Hypothesis:~      Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different~     doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and~     intraperitoneal white cell count).~      Aims:~        1. To examine the tolerability of different doses of intraperitoneal tPA and DNase~          compared to standard treatment.~        2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the~          addition of intraperitoneal tPA and DNase to usual therapy.~   "
120500|NCT01478685|"~     The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose~     (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in~     combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in~     subjects with relapsed or refractory solid tumors.~   "
120501|NCT01478672|"~     The purpose of this study is to evaluate whether the introduction of large-scale~     personalized and technology supported telemonitoring and health coaching interventions~     produces benefits in terms of health related quality of life, health status and empowerment~     of patients with a cardiovascular disease. In addition, the trials evaluate the economical~     and organizational impact of the new services and examine their acceptability by patients~     and health professionals.~   "
120502|NCT01478659|"~     The proposed study will be a randomized, double-blind, parallel-arm study. Participants will~     incorporate snack foods (bar/yogurt) containing 16 grams of fiber (fructooligosaccharide) or~     similar snack foods without the added fiber into their usual diets. The study period will~     include a 2-week pre-baseline assessment period and an 8-week treatment period. During the~     2-week pre-baseline period no study foods will be consumed however dietary intake will be~     assessed using a 24-hour online diet recall program. The first week of the 8-week treatment~     will serve as an acclimation period where only one serving of the study foods will be given~     (8 grams of fiber) per day. Participants will receive two servings (16 grams of fiber) per~     day for weeks 2 through 8 of the treatment period and 24-hour online diet recalls will be~     completed during weeks 4, 6 and 8.~      Hypothesis:~      Adults aged 18 to 50 years consuming their usual diet modified by incorporating yogurt and~     snack bars containing 16 grams of chicory root fiber (Frutalose®) will decrease their usual~     dietary intake to a greater extent compared to participants who receive similar snack foods~     without the added fiber.~   "
120503|NCT01478646|"~     The purpose of this study is to determine whether different types of breathing therapies in~     patients with COPD III-IV decrease dyspnea and increase activity.~   "
120504|NCT01478633|"~     The purpose of this study is to evaluate the efficacy and safety of galantamine in patients~     who failed to benefit from donepezil (patients switching from donepezil). In clinical~     practice, it is expected that galantamine will be used in patients switching from donepezil~     due to the insufficient efficacy of donepezil.~   "
120505|NCT01478620|"~     The objective of the study is to assess safety and impact of a non-antibiotic therapy~     approach with Canephron® N in the management strategy of uncomplicated lower urinary tract~     infections (UTIs).~   "
120506|NCT01478607|"~     The purpose of the study is to assess the safety of repeated applications of QUTENZA in~     reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.~   "
120507|NCT01478594|"~     The objective of this study is to compare the progression free survival (PFS), overall~     survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of~     response (DoR), quality of life, safety and tolerability of tivozanib in combination with~     mFOLFOX6 and bevacizumab in combination with mFOLFOX6.~   "
120508|NCT01478581|"~     The primary objective of this study is to determine the efficacy of PCI-32765, both as a~     single agent and in combination with dexamethasone, in subjects with relapsed or relapsed~     and refractory Multiple Myeloma (MM)~   "
120509|NCT01478568|"~     The study aims to evaluate if blood levels of desipramine change whilst being dosed at the~     same time with daily mirabegron.~   "
120510|NCT01478555|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical~     administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic~     solution) compared to Vehicle and DuraSite alone.~   "
120511|NCT01478542|"~     The purpose of this study is to improve the outcome of elderly patients with CD20+~     Aggressive B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy~     by using an optimised schedule of the monoclonal antibody Rituximab, substituting~     conventional by Liposomal Vincristine and by a PET-guided reduction of therapy in~     Combination with Vitamin D Substitution.~   "
120512|NCT01478529|"~     A study to evaluate how much of the active compound of mirabegron comes into the blood~     circulation when given as a controlled-release pill as compared to given intravenously.~   "
120513|NCT01478516|"~     The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal~     autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in~     vitreous body.~   "
120514|NCT01478503|"~     The study aimed to compare age and gender differences for increasing doses of mirabegron~     when given to healthy young and elderly males and healthy young and elderly females.~   "
120515|NCT01478490|"~     The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy~     poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol~     change whilst being dosed at the same time with daily miragebron.~   "
120516|NCT01478477|"~     This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in~     patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole.~     Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients~     receiving hormone therapy for breast cancer.~   "
120517|NCT01478464|"~     Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical~     exercise. Therapists often provide manual massage with the hands to acutely relief the~     soreness. Alternatives to manual hand massage can be useful for therapists. Here the~     investigators examine the acute effect of a massage roller on DOMS in the hamstring~     muscles~   "
120518|NCT01478451|"~     Many people experience pain, tenderness and soreness of joint and muscles, both in sport and~     working life. Pain killers can provide acute relief of pain, but may not be a feasible~     solution for all people. Here the investigators examine the acute effect of massage and~     exercise on induced muscle tenderness (delayed onset muscular soreness).~   "
120519|NCT01478438|"~     This study will determine the rate of complete tumor ablation of small breast cancers (≤~     20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and~     specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post~     ILT ablation as correlated to histopathology from the post-ablation excision.~   "
120520|NCT01478425|"~     Study design: Randomized, controlled, double-blind, parallel, multicentre multinational~     clinical trial, to show superiority of an active therapy as compared to a control therapy on~     intermittent or persistent Allergic Rhinitis.~      Primary objective:~        1. To show that a topical microemulsion is superior to a sterilized saline solution to~          prevent deterioration in the health related quality of life, in patients with~          intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree~          or grass pollen.~           Secondary objectives~        2. To explore the effect of a topical microemulsion, as compared to a sterilized saline~          solution, for the prevention of nasal and ocular symptoms in patients with intermittent~          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass~          pollen.~        3. To explore the effect of a topical microemulsion, as compared to a sterilized saline~          solution, in the utilization of symptomatic medications, in patients with intermittent~          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass~          pollen.~        4. To assess the patient's satisfaction with a topical microemulsion treatment, as~          compared to a sterilized saline solution, in patients with intermittent or persistent~          allergic rhinitis due to sensitization to birch, olive tree or grass pollen.~        5. To assess the safety of a topical microemulsion, as compared to a sterilized saline~          solution, administered to patients with intermittent or persistent allergic rhinitis~          due to sensitization to birch, olive tree or grass pollen.~      This is a clinical investigation study of a Class 1 medical device product. This is a~     prospective study of an active medical device versus a control medical device.~      It was considered feasible to recruit 10 patients patients per center, and therefore the~     study should be conducted in 10 centers. To get treatment balance within each center, a~     total of 100 patients should be recruited.~   "
120521|NCT01478412|"~     This trial is to determine if prostate target delineation obtained through an ultrasound~     based system is equivalent in accuracy to the MRI image fusion, and if alignment correction~     vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray~     imaging for daily prostate positioning.~   "
120522|NCT01478399|"~     Primary objective:~      To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose~     administered by subcutaneous injection to subjects with normal renal function and impaired~     renal function.~      Secondary objectives:~      To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a~     subcutaneous injection in adult subjects with normal renal function and impaired renal~     function.~   "
120523|NCT01478386|"~     Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more~     effective in treating the symptoms of knee OA then treating with viscosupplementation alone~   "
120524|NCT01478373|"~     The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients~     with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib~   "
120525|NCT01478360|"~     This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial~     asthma that is poorly controlled with the current standard of care.~   "
120526|NCT01478347|"~     The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population~     potentially at risk for meningococcal disease (e.g. lab workers).~      In the second part of the study additional blood samples of high responding vaccinated~     subjects will be collected for the purpose of generating a control serum panel for the human~     serum bactericidal assay (hSBA) tests.~   "
120527|NCT01478334|"~     The primary aim of the study is to investigate if 10 weeks of high intensity interval~     training improve inflammatory status in patients with rheumatoid arthritis.~   "
120528|NCT01478321|"~     This phase II trial studies how well giving hypofractionated radiation therapy together with~     temozolomide and bevacizumab works in treating patients with high-grade glioblastoma~     multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated~     radiation therapy, that delivers a high dose of radiation directly to the tumor may kill~     more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more~     tumor cells.~   "
120529|NCT01478308|"~     This study is being conducted to determine the effectiveness of standard 3 weekly treatments~     using docetaxel and prednisone with metformin in patients with castration-resistant~     metastatic prostate cancer.~      It is also being conducted to determine the levels of toxicity of metformin when added to~     every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic~     prostate cancer.~   "
120530|NCT01478295|"~     The purpose of this study is to evaluate the effectiveness of a structured nursing~     intervention (PCE), including two types of intervention defined in the literature (coping~     strategies promoting social support and empowerment through health education), which has an~     effect on the perceived quality of life for the caregiver, when compared with conventional~     intervention or non-support.~   "
120531|NCT01478282|"~     The main goal of this study is to improve safety and efficiency of clinical practice with~     the new generation of oral anticoagulants.~        1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on~          platelets and coagulation mechanisms under flow conditions.~        2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and~          FVIIa) to reverse the effects induced by the new anticoagulants.~      These studies will be carried out ex vivo in blood samples obtained from healthy volunteers~     undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in~     previous clinical trials.~   "
120532|NCT01478269|"~     This study is a retrospective analysis of an homogeneous population of patients with~     aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to~     reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups~     with a clinical and therapeutical relevance.~   "
120533|NCT01478256|"~     This study looks at the improvements in signs and symptoms in patients with inflammation of~     the lids, blepharitis, using two different FDA approved topical antibiotic agents,~     Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients~     for microbiologic evidence of improvement.~   "
120534|NCT01478243|"~     Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases,~     functional problem which translates to various repercussions on person's quality of life,~     including much stress and insecurities.~      Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common~     condition and the investigators can make assumptions about those living with keloids, the~     investigators do not know the actual impact of the illness on the overall performance of~     patients' and how this disease, day to day, is impacting their lives. The investigators are~     conducting this study, aimed to investigate the psychosocial impact of keloid on daily life.~     Information is collected anonymously. You must be 18 years of age or older to take this~     survey. Parents can respond on behalf of their children who are not 18 years of age yet. The~     online survey will take 20-30 minutes to complete.~   "
120535|NCT01478230|"~     Subjects will be screened within 28 days before the first study treatment to confirm that~     they meet the requirements to participate in the trial. They will return to the site for two~     treatment visits, at least 12 hours each, and at least one day in between visits. At each~     visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11~     hours. The investigator (or an appropriate delegate at the investigator site) will obtain~     informed consent from each subject. Blood samples will be drawn on a special schedule. The~     total predicted amount of blood sampled from each subject is 174 mL over the whole study.~     Subjects will be required to follow specific smoking and dietary restrictions and rate their~     urges to smoke, general liking of the product, and how easy the product is to use.~   "
120536|NCT01478217|"~     The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute~     respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic~     ultrasonographic assessment of lung recruitment.~   "
120537|NCT01478204|"~     The purpose of this study is to evaluate sleep quality in patients with mild to moderate~     Alzheimer's disease treated with anticholinesterase drugs in clinical practice.~   "
120538|NCT01478191|"~     This is a retrospective analysis of a homogeneous cohort of patients with~     relapsed/refractory HL that received IGEV scheme as induction therapy to HDCT and AHSCT for~     reassess the most common prognostic factors and try to identify a prognostic score with~     clinical and therapeutic relevance by using 6 clinical tools:~        1. B symptoms(yes/no)~        2. relapse in previously irradiated areas(yes/no)~        3. Ann Arbor Stage (III/IV vs I/II)~        4. disease status at accrual (refractory vs relapsed)~        5. Early relapse within 12 months of Complete Response (CR) versus late relapse after~          Complete Response (CR) lasting > l2 months,~        6. extranodal involvement (yes/no).~   "
120539|NCT01478178|"~     The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and~     the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma.~     Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be~     evaluated.~   "
120540|NCT01478165|"~     A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the~     incidence of postoperative nausea and vomiting (PONV).~      Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is~     added to TIVA.~   "
120541|NCT01478152|"~     In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation~     solution will be investigated in subjects with mild bronchial asthma. This dose-finding~     study will estimate the minimum effective dose and will assess the safe dosage, in terms of~     the quantity given to patients. The results will be compared to baseline measurements. The~     results regarding Sputum measurements will be compared to measurements after placebo~     administration.~   "
120542|NCT01478139|"~     The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula~     Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.~   "
120543|NCT01478126|"~     The purpose of this study is to determine whether perioperative glutamine administration~     possess protective properties on internal organs (heart and gut) in patients with coronary~     atherosclerosis, operated under cardiopulmonary bypass.~   "
120558|NCT01477931|"~     The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride~     extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with~     atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended~     release (Wellbutrin XL®) in patients with MDD with atypical features.~   "
120559|NCT01477918|"~     The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean~     patients with schizophrenia.~      Primary objective:~      • To investigate the prevalence of the MetS in Korean patients with schizophrenia~      Secondary objectives:~      • To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical~     antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more~     antipsychotics group (polypharmacy)~   "
120544|NCT01478113|"~     This study aims to identify a novel enhancement strategy for residual symptoms of major~     depressive disorder (MDD) Dopamine (DA) has been viewed as a pleasure neurotransmitter for~     over 30 years. Yet recent data from animal and human studies suggest that dopamine has~     greater effects on wanting than on liking. Therefore, the investigators of this study~     have hypothesized that amphetamine/d-amphetamine (AMPH), a medication which increases~     dopamine transmission in the reward centers of the brain, may have a more powerful~     antidepressant effect in combination with well-being therapy (WBT), a specific type of~     cognitive-behavioral therapy, which helps individuals with depression to increase their~     contact with natural rewards and decrease reward-interfering thoughts.~      The investigators will test their hypothesis by randomizing 40 individuals with residual~     symptoms of depression, already taking an antidepressant that affects serotonin (e.g.~     Prozac, Paxil), to 8 weeks of treatment with either WBT in combination with AMPH, or WBT~     with pill placebo. The effectiveness of each treatment will be measured using a reliable~     scale, called the Hamilton Depression Rating Scale.~      The investigators have also hypothesized that people assigned to the stimulant/WBT group~     will have greater improvements in functioning, well-being, and positive affectivity than~     those the people assigned to the WBT/placebo group.~   "
120545|NCT01478100|"~     The investigators examined the feasibility of treatment planning using virtual coronary~     revascularization and fractional flow reserve (FFR) CT before the invasive procedures.~   "
120546|NCT01478087|"~     The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in~     patients with chronic non-ischemic dilated cardiomyopathy (DCM).~   "
120547|NCT01478074|"~     This is a single-center open-label phase I clinical trial of delivering haploidentical~     natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of~     ALT-801 in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The study will be~     conducted at M.D. Anderson Cancer Center (MDACC) and MDACC Children's Cancer Hospital in~     Houston, Texas.~   "
120548|NCT01478061|"~     The Study plan is a post-market prospective, multi-center, open-label registry. The vein~     graft failure rates for the currently commercialized C-Port devices will be compared to an a~     priori rate taken from the peer-reviewed literature.~   "
120549|NCT01478048|"~     The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/~     Dexamethasone will prolong the time before myeloma worsens [progression free survival~     (PFS)].~   "
120550|NCT01478035|"~     To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in~     patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin~     will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50~     yrs.~   "
120551|NCT01478022|"~     This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU~     200 and IBU and ISO combinations (200 +20) given in single dose.~      This study is being conducted to support the submission for new indication in treatment of~     the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular~     dystrophy.~   "
120552|NCT01478009|"~     Upper respiratory tract infections are a major source of morbidity throughout the world.~     Extracts of Korean red ginseng have been found to have the potential to modulate both~     natural and acquired immune responses. The investigators sought to examine the efficacy of~     an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of~     Korean red ginseng will be investigated in healthy subjects during the influenza season.~   "
120553|NCT01477996|"~     This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge)~     for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for~     standard recommendation regarding the optimal needle size for IVT.~   "
120554|NCT01477983|"~     This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different~     pharmacological approaches to improve long-term outcome of catheter ablation for atrial~     fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by~     Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use~     after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or~     persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio~     before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications~     or substantial bradycardia identified first after ablation for persistent AF, patients will~     be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the~     procedure (EAST-AF Trial).~   "
120555|NCT01477970|"~     The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling~     the daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are~     at risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian~     stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled~     because of OHSS were compared to 76 women of a control group. All cases of the study group~     were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or~     later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in~     diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of~     GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau~     before hCG was given. A marked decrease or plateau of estradiol levels was observed the day~     of oocyte retrieval while the pregnancy rate was not adversely affected when compared with~     an optimum ovarian response cycles. None of the women were cancelled or developed OHSS.~      In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the~     ovarian stimulation, the estradiol rise could be blocked while a minimal follicular~     stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.~   "
120556|NCT01477957|"~     The purpose of this study is:~        1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid~          storage can be improved by bariatric surgery~        2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in~          patients with obesity (degree 2-3)~        3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is~          associated with the degree of liver inflammation~   "
120557|NCT01477944|"~     To describe the new statins prescription pattern in Catalonia (getting their first~     prescription for any statin, or receiving a change in their statin treatment including~     switching, changing in doses or adding ezetimibe/fibrates) since September 2009.~   "
120560|NCT01477905|"~     The investigators attempted to determine an adequate priming volume for our infusion system,~     and investigated the extent of a possible delay of the drug effect, that would result from~     mechanical defects of the infusion system, with or without priming the infusion system,~     using direct gravimetrical measurements of virtual infusate amounts during target controlled~     infusion of 2 remifentanil diluents.~   "
120561|NCT01477892|"~     The purpose of this study is to evaluate safety and efficacy of continuous infusion of~     remifentanil in preterm infant with mechanical ventilator for control of procedural pain~     using two different dosage of remifentanil.~   "
120562|NCT01477879|"~     This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus~     placebo applied every 3-4 hours to herpes lesions.~   "
120563|NCT01477866|"~     The main aim of the present study is to test the efficacy and safety of CITOGENEX~     administration in patients with colon-rectal cancer.~   "
120564|NCT01477853|"~     This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination~     with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol~     (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively.~     Following a single-blind placebo run-in period, participants were to be randomized to one of~     three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus~     atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54),~     participants were to receive either sitagliptin plus atorvastatin or glimepiride plus~     atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in~     combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and~     that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than~     sitagliptin alone.~   "
120565|NCT01477840|"~     The purpose of this study is to determine whether the effect of sublingual misoprostol is~     better than infusion oxytocin in reduction of blood loss at cesarean deliveries.~   "
120566|NCT01477827|"~     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status~     of adolescent schoolchildren in each season throughout the year.~   "
120567|NCT01477814|"~     The goal of the study is to conduct a randomized clinical trial to test several office-based~     strategies for improving colon cancer screening among individuals who are regular patients~     at 16 family practice physician offices in the state of Iowa. These offices are members of~     the Iowa Research Network (IRENE), a rural practice-based research network. The~     interventions to be tested are increasing in intensity from the usual care provided in the~     office, to physician chart reminders, mailed educational materials to patients, a fecal~     immunochemical test with postage-paid return envelope, and a telephone call designed to~     determine attitudes and barriers to screening, and to motivate subjects to get screened. Our~     main research questions are: 1)do attitudes toward CRC screening change after providing~     educational materials about CRC screening? 2)do mailed educational materials and a FIT, with~     or without a telephone reminder, result in increased rates of CRC testing with the FIT?~   "
120568|NCT01477801|"~     The purpose of this study is to determine whether cholecalciferol supplementation in~     patients with chronic heart failure and low vitamin D levels improves:~        1. performance at six minutes walking test~        2. echocardiographic parameters~        3. neurohormonal imbalance~   "
120569|NCT01477788|"~     The objective of the study is to create a test that will discriminate between malignant and~     benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about~     800 women and at the end of the study the investigators will combine data from the woman's~     history, the sonographic characters of the mass and serum biological markers along with the~     woman's outcome (which means - whether the mass was malignant, benign, or disappeared or~     remained constant with no intervention).~   "
120570|NCT01477775|"~     A subset of patients recruited in the main MATRIX study will be randomized after~     intervention but before discharge to standard of care (the treating physician will decide~     which oral P2Y12 inhibitor will be added on top of aspirin) versus a customized approach~     based on an algorithm which integrates phenotypic information, including but not limited to~     residual on-treatment platelet reactivity assessed via VerifyNow P2Y12 Assay.~   "
120571|NCT01477762|"~     Posttraumatic stress disorder (PTSD) occurs in some people after exposure to events that~     cause extreme fear or helplessness. The incidence of war zones worldwide and the prevalence~     of violence in large cities in the U.S., increases the likelihood that people will~     experience a traumatizing event in their lifetime. About 1 in 10 people who survive such~     events will develop PTSD, while most people will get better over time. This suggests that~     some people may have biological vulnerabilities that make it harder for them to recover. One~     of these biological risk factors may be related to how stress hormones work in people who~     get sick. Another is how people react to things that make them afraid or nervous, we have~     found that PTSD patients have higher than normal fear reactions. The part of the brain that~     reacts to fearful stimulation is linked to stress hormones; the purpose of this study is to~     examine how these systems interact. The study will suppress stress hormones (cortisol)~     production in one group of participants, while another will get a placebo. When their~     cortisol is suppressed, the participants will undergo a startle study to see if their fear~     responses are decreased. We expect that people PTSD will show a normal fear response when~     their cortisol levels are reduced, similar to people without PTSD. This research can help~     discover new medicines for people with PTSD.~   "
120572|NCT01477749|"~     To demonstrate that sipuleucel-T can be successfully manufactured for subjects with~     metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.~   "
120573|NCT01477736|"~     The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor~     injections of botulinum toxin type A on urodynamic parameters and quality of life in~     patients with neurogenic detrusor overactivity following spinal cord injury.~   "
120574|NCT01477723|"~     Study objectives are to verify the loss of lean mass during a hospital stay in a group of~     older patients; to evaluate the effects of consuming a high-calorie complete and balanced~     oral nutritional supplement; to collect post-discharge information.~   "
120575|NCT01477710|"~     This study will compare three methods of delivering mechanical ventilation using a test~     lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a~     mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints~     include respiratory rate and tidal volume.~   "
120577|NCT01477684|"~     The purpose of this study is to perform a descriptive, content-based analysis on the~     different forms of documentation for in-flight medical emergencies that are currently~     provided in the emergency medical kits on board commercial airlines.~   "
120578|NCT01477671|"~     This is a descriptive prospective community-based seroprevalence study.~      Primary objective:~        -  To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against~          dengue in healthy 5 to 10 year-old children in India.~      Secondary objectives:~        -  To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the~          antibodies in positive (IgG) samples~        -  To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis~          in healthy 5 to 10 year-old children in India.~   "
120579|NCT01477658|"~     Recent studies have shown that chronic stimulation of the right ventricle can cause~     deleterious effects to cardiac function and synchronicity. The occurrence and consequences~     of this phenomenon in children and young patients with cardiac pacemaker due to advanced~     atrioventricular block (AVB) are still unknown.~      Thus, our aims is to assess the chronic effects of cardiac pacing in children and young~     patients with advanced AVB and its impact on clinical, functional and echocardiographic~     parameters.~   "
120580|NCT01477645|"~     The purpose of this study is to determine whether use of lead free ammunitions cause more~     respiratory problems than use of lead containing ammunitions.~   "
120581|NCT01477632|"~     This trial is conducted in Europe. The aim of this trial is to determine the extent of~     bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a~     marketed estradiol/norethisterone acetate (NETA) preparation.~   "
120582|NCT01477619|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study~     will provide an assessment of the effect, if any, of age and body size on the safety and~     tolerability profile and the pharmacokinetics of tasimelteon.~   "
120583|NCT01477606|"~     This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute~     Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.~      The primary efficacy object is to evaluate the impact of midostaurin given in combination~     with intensive induction, consolidation including allogeneic hematopoietic stem cell~     transplantation and single agent maintenance therapy on event-free survival (EFS) in adult~     patients with AML exhibiting a FLT3-ITD.~      Sample size: 440 patients~      The treatment duration of an individual patient is between 18 and 24 months. Duration of the~     study for an individual patient including treatment (induction, consolidation [chemotherapy~     or allogeneic SCT], maintenance and follow-up period: Maximum 7.5 years~   "
120584|NCT01477593|"~     Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide.~     Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed~     routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually,~     more and more Chinese male are willing to undergo it with themselves and their sons. But~     there are also some complications with circumcision, such as pain, edema, infection, and~     hemorrhage. Considering of that, physicians continually manage to improve their surgical~     methods and analgesic techniques.~      In the study of Peng, a disposable minimally invasive circumcision anastomosis device named~     Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was~     introduced to be applied in circumcision. And they concluded that method was quicker, safer~     and less pain than the conventional techniques of incision. In present study, we carry out a~     randomized controlled trail, using a different method as Peng introduced with this device in~     children's circumcision (Yan's), compared with the method as Peng used and the conventional~     technique in our hospital, and then observe the outcomes.~   "
120585|NCT01477580|"~     This study will determine whether at least one formulation of an experimental dengue vaccine~     (V180) is safe and causes an immune response.~   "
120586|NCT01477567|"~     The main purpose of this study is to determine the safety of LY3009385 in healthy~     participants. The study drug is given as a single dose, by injections under the skin. Side~     effects will be documented. This study is approximately 28 days not including screening.~     Screening is required within 28 days prior to the start of the study.~   "
120587|NCT01477554|"~     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching~     the internationally established Millennium Development Milestones (MDM) is still a distant~     goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate~     and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency~     Training Program is an innovative training strategy based on simulations designed to train~     hospital personnel to respond to obstetric emergencies. The objective of this study is to~     implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in~     influencing key behaviors in hospital practices, as well as measuring maternal and neonatal~     outcomes in intervention versus control hospitals.~   "
120588|NCT01477541|"~     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching~     the internationally established Millennium Development Milestones (MDM) is still a distant~     goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled~     attendance during pregnancy and delivery. This project uses an innovative strategy of~     integrating professional midwives and licensed obstetric nurses into rural medical centers~     in the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services,~     and puerperium care. The goal of the research is to increase use of best practices in~     intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful~     care; and improve maternal and neonatal outcomes. We posited that medical centers receiving~     the intervention would provide better care and have better maternal and neonatal outcomes~     than those that did not receive the intervention.~   "
120589|NCT01477528|"~     The purpose of this observational study is to obtain multi-center data on HeartMate II~     (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the~     incidence of thrombotic and bleeding adverse events associated with these regimes.~   "
120590|NCT01477515|"~     To investigate the relationship between dietary intake, body habitus, and endocannabinoid~     levels in end stage renal disease patients as compared to matched controls.~   "
120654|NCT01475643|"~     The objective of this study is to compare the efficacy and safety for the treatment of~     postoperative inflammation following ocular surgery for childhood cataract.~   "
120591|NCT01477502|"~     recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are~     a frequent problem, leading to significant morbidity and to a decreased quality of life.~        -  until today, there is no effective prophylaxis for UTI for patients with spinal cord~          injury.~        -  homeopathy has been shown to be an effective treatment option in several chronic~          diseases~        -  study hypothesis: the addition of homeopathic assessment and treatment to a standard~          prevention strategy for recurrent UTI will significantly reduce the number of~          symptomatic UTI per year in this group of patients compared to standard prevention~          alone~   "
120592|NCT01477489|"~     The purpose of this study is to determine the maximum tolerated dose of veliparib that can~     be given while a patient is receiving radiation therapy.~   "
120593|NCT01477476|"~     This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to~     evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of~     standard therapy for diabetic ketoacidosis in children and its effect on intracranial~     pressure.~   "
120594|NCT01477463|"~     The purpose of this study is to determine the signaling pathways and changes in gene~     expression in melanocytes of subjects with a history of non-melanoma skin cancer who are~     exposed to oral vitamin D. If vitamin D is found to inhibit a signaling pathway involved in~     the development of melanoma such as BRAF, a protein involved in cell proliferation, then~     oral vitamin D could be explored further as a chemoprevention for melanoma skin cancer.~   "
120595|NCT01477450|"~     This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse~     altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.~   "
120596|NCT01477437|"~     In summary, there is a clear need to improve knowledge and self-management skills in~     adolescents with hemophilia. To date, there are no published accounts of self-management~     programs for this population. Evidence from other chronic diseases that affects teens~     suggests that by developing an interactive Internet-based program, the investigators can~     meet the educational needs of adolescents with hemophilia and improve their ability to~     manage their hemophilia. In the long-term, improved self-management should result in a~     smoother and more successful transition to adult care and improve patient outcomes.~   "
120597|NCT01477424|"~     The purpose of this study is to determine if Warfarin is affected by PA21.~   "
120598|NCT01477411|"~     The purpose of this study is to determine if Digoxin is affected by PA21.~   "
120599|NCT01477398|"~     The proposed study will measure the incidence of adverse events and the decrease in time to~     meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea~     are used during emergence.~   "
120600|NCT01477385|"~     This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the~     treatment of clinically caries lesions in enamel, with radiographic image restricted to the~     enamel or the outer third of dentin on the proximal surfaces of primary and permanent~     posterior teeth. It also aims to compare it to the resin infiltration and to the control of~     proximal biofilm through the oral hygiene.~   "
120601|NCT01477372|"~     The purpose of this study was to assess the effectiveness of a moderated physical exercise~     program called Blooming Exercise Program (BEP) developed during pregnancy in order to~     control excessive maternal weight gain and its consequences. Additionally, other objectives~     of the study were to analyse the influence of BEP on urinary incontinence, on the other~     pregnancy outcomes and on the perception of the pregnant's health~   "
120602|NCT01477359|"~     Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations~     (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not~     uncommon. A Canadian physician survey found that most physicians do not investigate for CS~     as a possibility in these situations. Thus many patients with clinically important CS are~     going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these~     patients' leads to significant mortality and morbidity.~      There are no published clinical consensus guidelines on treatment of CS. Corticosteroid~     therapy is advocated by most experts. This is based on very modest data from small~     retrospective observational studies using variable definitions of clinical response. The~     effect of corticosteroid treatment on the clinical course of CS has not been studied in~     prospective studies and will be one of the aims of this project. Recent physician surveys~     regarding CS, in Canada and the US, found that current clinical practice varies widely. The~     2008 American College of Cardiology/American Heart Association/Heart Rhythm society~     guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent~     sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.~      A multi-center collaborative approach to study CS is greatly needed. The investigators~     propose exactly that i.e. a multi-center prospective cohort to start to answer clinical~     questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP.~     The group includes respirologists with an interest in sarcoidosis, cardiac~     electrophysiologists, cardiac imaging specialists with extensive experience in imaging of~     sarcoidosis and biostatisticians. The research will be in two phases and his current~     application is for Phase 1 (pilot) of the prospective cohort. Twenty Canadian centers have~     committed to participate in this pilot study.~   "
120603|NCT01477346|"~     The purpose of this study is to determine in community-derived patients with gout the~     effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects~     recommended best practice (including patient information concerning gout, its prognosis and~     its non-pharmacological and drug options).~   "
120604|NCT01477333|"~     The purpose of this multi-center, open-label, safety and tolerability study is to assess the~     addition of UT-15C SR to patients currently receiving Tyvaso (treprostinil) inhalation~     solution. The study will consist of a 24-week evaluation period followed by a long-term~     safety follow up. Assessments will include: hemodynamics, 6MWT, Borg dyspnea score,~     NT-proBNP, WHO functional class, and safety assessments.~      Eligible patients will have a diagnosis of PAH, currently be receiving Tyvaso, and may be~     receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a~     stable dose for ≥ 30 days). At Baseline, subjects will receive the first dose of 0.125 mg~     UT-15C SR.~   "
120605|NCT01477320|"~     study is to determine if proton pump inhibitors plus enteral nutrition is superior to~     enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in~     terms of incidence of overt and significant GI bleeding related to stress gastropathy.~   "
120606|NCT01477307|"~     In patients with NAFLD/NASH, changes in liver lipid composition and function tests following~     a short dietary intervention are associated with changes in gut microbiota~   "
120655|NCT01475630|"~     The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain~     and mandibular function in patients with anterior disc displacement without reduction~     (ADD-R) or closed lock of the TMJ and this in a randomized controlled trial design.~   "
120607|NCT01477294|"~     The main purposes of this randomized cross-over trial are to characterize and compare the~     effects of a moderate dose of caffeine intake in healthy physically active males on~     hydration and energy metabolism specifically:~        1. Total body water and its compartments (intracellular and extracellular) assessed by by~          dilution techniques, and hydration state by urine specific gravity;~        2. Total energy expenditure by double labeled water, resting energy expenditure by~          indirect calorimetry, and physical activity energy expenditure;~        3. Energy expenditure in physical activity of daily living, in particular duration and~          intensity of activity.~        4. If the changes occurred between placebo and caffeine ingestion on the main outcomes~          were dependent on specific covariates, namely body composition and dietary intake.~   "
120608|NCT01477281|"~     The objective is to evaluate the effectiveness of the safety of Daflon in decreasing~     symptoms resulting from chronic venous insufficiency when compared with Daflon.~   "
120609|NCT01477268|"~     Major depression is a very common health problem affecting older persons. The present~     standard of treatment is with medications called antidepressants. Antidepressants have~     been studied extensively in older persons with normal brain function and have been shown to~     be effective. However, certain types of brain dysfunction called executive impairment~     (inability to do higher order thinking) may lead to poor treatment outcomes. This study will~     compare how older depressed people with different levels of executive impairment respond~     differently to standard antidepressant treatment. Knowing this information will lead to more~     rational targeting of available treatments, leading to improved treatment outcomes.~   "
120610|NCT01477255|"~     This investigation seeks to determine the feasibility of an electronic diary methodology~     among pediatric cancer patients and healthy matched controls. Levels of study participation~     and compliance will be assessed to assist with determining overall feasibility. Results will~     offer insight into the effectiveness of this means of data collection with a pediatric~     oncology population, and will examine how psychosocial and contextual factors contribute to~     the resiliency that has been demonstrated by children with cancer. Findings will provide~     data for the design and implementation of a future, larger-scale study with this pediatric~     population that implements an electronic daily diary methodology.~   "
120611|NCT01477242|"~     The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For~     this evaluation, the investigators will perform a multi-center, double-blind,~     placebo-controled, randomized study. The investigators assumption is that oral ondansetron~     prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.~   "
120612|NCT01477229|"~     Rectal cancer is a common type of cancer occuring more frequently in men but also common in~     women. Almost 60% of the patients survive 5-years and the treatment has been continuously~     developed in the last three decades. The aim of the QoLiRECT study is to increase the~     knowledge about symptoms, functional impairments, quality of life (QoL) and psychological~     and socioeconomic burden in an unselected population of rectal cancer patients.~   "
120613|NCT01477216|"~     The aim of this study to investigate methodological aspects that may affect glycemic index~     (GI) and insulinemic (II) values. In addition, we will measure GI and II values for typical~     Finnish carbohydrate-rich foods and provide a database of GIs for Finnish foods.~      The specific aims of this study are:~        -  to compare glycemic responses and GIs analyzed from capillary and venous blood to~          compare glucose against white bread as the reference food, and to study the effect of~          number of reference tests on GI values. For each setting of the tested parameters, we~          determined the glycemic indices of rye bread, oatmeal porridge and instant mashed~          potato~        -  to examine the glycaemic and insulinaemic responses of a mashed potato-based meal when~          a high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein~          and salad together were added to the meal. Furthermore, we studied how the predicted~          and measured GI values of the mixed meal differed from each other.~        -  to examine the effects of two different coffee portions with glucose and~          caffeine-containing soft drinks on postprandial glucose and insulin responses. Further~          objectives were to study how coffee and different accompaniments affect glucose and~          insulin responses.~        -  to measure GI values for typical Finnish foods~        -  to study the effects of berries on glycemic and insulinemic responses~        -  to examine the effects of overweight and glucose tolerance on the glucose, insulin and~          lipid responses to an HGI meal and an LGI meal.Furthermore, the second aim was to study~          the effect of BMI and glucose tolerance on the GI measured.~        -  to compare methodological choices in insulin measurement~        -  to investigate the effect of alcohol on postprandial glucose and insulin responses, and~          to determine glycemic and insulinemic indices values for beer and non-alcoholic beer~   "
120614|NCT01477203|"~     MAN-BIOPSY pursues the concrete research question whether novel biological and~     psycho-physiological clusters or categories can be defined to improve treatment and minimize~     side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and~     endocrinological parameters. One major aspect of our research approach is its focuses on the~     identification of dysfunctions in fundamental information processing mechanisms and~     neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.~      The main objectives of MAN-BIOPSY are therefore~        -  to identify biological and psycho-physiological parameters for major depressive~          disorders and anxiety disorders, and~        -  to identify predictive markers for treatment response and type/severity of side effects~          for these disorders.~   "
120615|NCT01477190|"~     This is a blinded randomized controlled trial in patients undergoing laparoscopic colon~     surgery. The aim of this study is to assess whether spinal analgesia with a mixture of~     bupivacaine and morphine provides better pain relief than systemic morphine in a group of~     patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS)~     program.~      Twenty patients will receive spinal analgesia and twenty patients will receive only Patient~     Control Analgesia (PCA).~   "
120616|NCT01477177|"~     The purpose of this pilot study is to provide an initial assessment of the feasibility,~     safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low~     grade and high grade dysplasia by use in a small number of patients so as to support, or~     otherwise, the development of a full-scale trial.~   "
120617|NCT01477164|"~     Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and~     function in older people. Exercise can increase the making of new proteins and removal of~     older proteins, but it is not known if the effect changes with aging or type of exercise.~     The investigators will determine the ability for endurance, resistance, or a combination of~     exercise training to remove older-damaged proteins and make newer-functional muscle proteins~     in groups of younger and older people. The investigators will particularly study protein~     that are involved with energy production (mitochondrial proteins) and force production~     (contractile proteins).~      Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger~     people.~      Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of~     contractile and mitochondrial proteins in younger and older people.~      Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of~     contractile proteins in younger and older people.~   "
120618|NCT01477151|"~     Anesthesia practice in the 21st century is increasingly outcomes-oriented and~     evidence-based, but there remain significant gaps in our knowledge, even for~     commonly-encountered clinical situations. Currently, the two most commonly used drugs used~     for maintenance of anesthesia in cardiac surgical patients are isoflurane and sevoflurane.~     There is a belief among many cardiac anesthesiologists that sevoflurane is a better cardiac~     anesthetic than isoflurane, but there is very little data to support this notion. In fact,~     very little is known about their comparative effects on important patient outcomes because~     there has not been a large head-to-head prospective randomized clinical trial. This project~     will supply the data necessary to critically compare the two anesthetics.~   "
120619|NCT01477138|"~     Background:~        -  Potential negative effects of pacing in the RV-apex are well documented~        -  However, study results comparing septal / RVOT-pacing versus RV-apical pacing~          controversial.~        -  The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with~          an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE~          trial [DANPACE, ESC 2010, Stockholm].~      Aim:~      - to evaluate chronic effects of proven right ventricular septal compared to minimized right~     ventricular septal pacing in patients with SSS~      Inclusion criterion:~      -Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)~      Exclusion criteria:~        -  Life expectancy < 2 years~        -  Age <18 years~        -  Noncompliance with regard to participation in the study~        -  Pregnancy~        -  AV block ° 2 and higher~        -  Permanent atrial fibrillation~        -  Heart failure NYHA III and IV, reduced LV-EF <40%~        -  ICD indication~        -  Acute coronary syndrome. PCI or CABG <3 months~        -  Heart transplant~        -  Placement of septal RV electrode is not possible~      Study design:~        -  Prospective, monocentric, randomized, double-blinded~        -  Run-in phase: for weeks AAI [R]-DDD [R]~        -  Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R]~          versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].~        -  FU: 6 and 12-months~      Primary endpoints:~      -LV ejection fraction and end-systolic LV volume after 12 months.~      Secondary endpoints:~      -LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD),~     AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR,~     VE/VCO2 slope; QoL scores (SF-36) after 12 months.~      Statistics/sample size estimation:~      In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups~     after 12 months:~        -  90% power/alpha 5%: 84 patients per group~        -  80% power/alpha 5%: 63 patients per group~             -  10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type~               1 error Analysis intention-to-treat and based on the finally programmed pacing~               mode.~      Material~        -  PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)~        -  pacing leads: market-released standard active electrodes~        -  RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB~          narrow <150 ms / inferior axis)~   "
120620|NCT01477125|"~     The purpose of this study is to evaluate whether computerised working memory training~     improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life~     in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a~     high-security prison facility (N=50).~   "
120621|NCT01477112|"~     Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms,~     the objective is to determine the effect of supplementation with β-carotene to type 2~     diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant~     plasma capacity, using doses similar to the daily nutritional requirement.~   "
120622|NCT01477099|"~     The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12%~     could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may~     be an important reservoir of pathogens that could cause pneumonia.~   "
120623|NCT01477086|"~     Sarcopenia is the loss of muscle mass and function that accompanies aging. The term~     sarcopenia comes from the Greek sarx (flesh) and penia (loss).~      Sarcopenia is a topic of great interest to geriatricians, and from 2010 discussing the~     possibility of considering it as a geriatric syndrome.~      Diagnostic criteria are reduced muscle mass, reduced strength and impaired physical~     performance. The presence of muscle mass reduction set presarcopenia diagnosis, when~     combined with one of the other two are talking about sarcopenia and when are the three is~     defined as severe sarcopenia.~      The hypothesis of our study is that sarcopenia is highly prevalent in older people with hip~     fracture. The increase in inflammatory indices of older people, along with bed rest,~     represent factors that accelerate the development of sarcopenia. These factors together~     could be the base of the high percentage of patients who do not recover the degree of~     autonomy before the fracture.~   "
120624|NCT01477073|"~     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of~     a multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female~     volunteers, in comparison with two marketed comparator products.~   "
120625|NCT01477060|"~     Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer~     in progression after first-line hormonal therapy.~      The study rationale is based on the potentiality of reversing endocrine-resistance by~     Lapatinib~        -  Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by~          HER2 family~        -  Modulation of energy balance and signals associated to survival through AMPK activation~          (via Calmodulin) Metformin~        -  Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with~          reduces proliferative effects downstream~        -  Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis~          (mTOR inhibition) and increased availability of intracellular energy Lapatinib and~          Metformin~        -  AMPK Doubleactivation, through different potentially additional mechanisms.~        -  Inhibition of proliferative mechanisms for interference on various intracellular target~             -  IR (A e/o B); IGFR~             -  EGFR; HER2~      Primary objectives :~      1. To assess the rate of patients free from disease progression at 3 months from~     randomization~      Secondary objectives :~        1. To assess the overall response rate~        2. To assess the duration of response~        3. To assess 3-years overall survival rate~        4. To assess tolerability of each proposed treatment Female patients with HER2-negative,~          ER and/or PgR positive breast cancer in progression after first-line hormonal therapy~          will randomized to receive: hormonal therapy + lapatinib or hormonal therapy +~          metformin or hormonal therapy + metformin + lapatinib with a ratio 1:1:1.~      For each arm of the study the following sample size is required:~        -  First step: 23 patients, for a total of 69 patients in all 3 arms~        -  Second step: further 33 patients, for a total of 168 patients in all 3 arms.~   "
120626|NCT01477047|"~     Prolonged wound drainage following total joint replacement surgery has been shown to be a~     predictor of postoperative infection. Several factors have been associated with delayed~     wound healing and increased risk of infection. Namely hypertension, obesity, diabetes,~     smoking and autoimmune disease have been shown to have a detrimental effect on wound~     healing. The purpose of this study is to verify those findings and determine additional~     pharmacological, surgical and patient related factors that may result in prolonged wound~     drainage, prolonged hospital stay and increased risk of infection~   "
120627|NCT01477034|"~     Chronic, low-grade adipose tissue inflammation is a major risk factor for type 2 diabetes~     mellitus. The cause of adipose tissue inflammation has remained largely unclear. We~     hypothesize that vitamin D deficiency predisposes individuals to the development of adipose~     tissue inflammation, and that treatment of vitamin D deficient subjects with high dose~     vitamin D will reduce adipose tissue inflammation.~   "
120707|NCT01476163|"~     This program allows physicians to request permission from Amicus Therapeutics (Amicus) for~     treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry~     disease. Treatment is open label for 6 months with renewal every 6 months.~   "
120628|NCT01477021|"~     This phase I trial studies the side effects and how well giving autologous T cells with~     cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or~     cannot be removed by surgery. Biological therapies, such as cellular adoptive immunotherapy,~     may stimulate the immune system in different ways and stop cancer cells from growing. Drugs~     used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving~     autologous T cells together with cyclophosphamide may kill more tumor cells.~   "
120629|NCT01477008|"~     The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic~     Cartilage Repair Implant (BiCRI, Exactech Taiwan) compared to marrow stimulation in the~     treatment of chondral and osteochondral lesions located on the medial femoral condyle,~     lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides~     an improvement in pain and function as compared to baseline, that is no worse than marrow~     stimulation at 1 year.~   "
120630|NCT01476995|"~     The objective of this study is to determine whether the finger tip images captured by the~     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale~     that characterizes trends consistent with known diagnoses identified by medical doctors.~     Specifically, the investigators hypothesize that the organ system involving any of a series~     of known active diagnoses will be identified in the EPIC ClearView Response Scale report~     with the intention of providing potential triage capabilities.~   "
120631|NCT01476982|"~     The primary objective of this feasibility study is to determine whether it is possible to~     conduct a study of the ClearView scan among patients under evaluation for acute~     cardiovascular events, as well as give insight into the performance of the ClearView scoring~     algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic~     tool that may assist the health care provider in rapid assessment of the systemic origin of~     the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource~     that may benefit an emergency department (ED) by offering expedited chest pain etiologic~     differentiation capabilities. The subsequent results have the potential to include more~     rapid chest pain patient diagnosis and appropriate disposition of non-cardiac chest pain~     (rule out MI); optimized precious resource expenditure (nursing, physician, inpatient or~     observation bed, etc.); lower costs to facility, patient and insurance company; and greater~     patient satisfaction rates due to decreased ED wait time.~   "
120632|NCT01476969|"~     The purpose of this study is to determine whether Remote Ischemic Perconditioning is~     effective on Acute kidney injury in adult valve replacement.~   "
120633|NCT01476956|"~     Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug)~     DMARD therapy or about to change DMARD therapy.~      Disease activity will be monitored systematically every 3 months by the Disease Activity~     Score.~      Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be~     made according to specific recommendations for patients receiving these therapies.~      Biomarker samples will be collected every 3 months and prior to change in DMARD and/or~     anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for~     biomarker studies and processed according to the international committee of Outcome Measures~     in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A~     urine sample (20 ml) will also be taken and processed as for serum.~      Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).~      Patients will be followed for 2 years.~   "
120634|NCT01476943|"~     The primary purpose is to describe the pattern of Belatacept use at the time of transplant~     and up to three years post-transplantation for all Belatacept treated patients.~   "
120635|NCT01476930|"~     Migraine is the most common recurrent headache. Current therapy of migraine headache~     consists of multiple drug groups for control of attack and prophylaxis against recurrent~     attacks. Emerging alternative medicine worldwide led investigators to evaluate the efficacy~     of cupping therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity,~     duration and frequency of attacks of migraine headache evaluated in two groups during six~     months from presentation.~   "
120636|NCT01476917|"~     The Study is a multi-center, prospective, open label, single-arm, three-month, long-term~     study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA).~     The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.~   "
120637|NCT01476904|"~     E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be~     able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo~     in a double-blinded manner.~   "
120638|NCT01476891|"~     For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation~     can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal~     growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the~     accessibility of MBSR programs to underserved cancer patients who are unable to attend~     available in-person groups. This study will examine whether patients are willing to~     participate and complete the program, and also whether the online program improves mood and~     stress.~   "
120639|NCT01476878|"~     The investigators plan to study high dose, single treatment radiation, using a plastic mask~     instead of a head frame that pins into a patient's skull. The investigators need to (1)~     quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that~     without the head frame the tumour control rate and risk of complications are similar to our~     previous experience using the head frame.~   "
120640|NCT01476865|"~     The purpose of this study is to establish the normality of sonographic synovial measures in~     joints more affected in rheumatoid arthritis patients and establish, in those joints, a~     sonographic value of synovium predictive of rheumatoid arthritis.~   "
120701|NCT01476241|"~     The investigators main endpoint was focused on the analysis of the type, rate and the impact~     of different clinical parameters on the complications of the PEG tube placements performed~     at the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In~     addition, the investigators aimed to compare the results with a historic cohort patient~     group (September 2005 - October 2008) sent to the Department of Surgery for PEG tube~     placement in order to evaluate the results of the changed routine.~   "
121293|NCT01468272|"~     This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination~     of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation~     already approved in adults.~   "
120641|NCT01476839|"~     This phase I clinical trial studies the side effects and best dose of radiolabeled~     monoclonal antibody therapy when given together with combination chemotherapy before stem~     cell transplant and to see how well it works in treating patients with primary refractory~     (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma.~     Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances~     to them without harming normal cells. Drugs used in chemotherapy, such as carmustine,~     etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or stopping them~     from spreading. Giving radiolabeled monoclonal antibody therapy together with combination~     chemotherapy may kill more cancer cells~   "
120642|NCT01475799|"~     The purpose of the study is to determine the safety and performance of the Direct Flow~     Medical study valve and delivery procedure.~   "
120643|NCT01475786|"~     The purpose of this study is to determine if VM202 is safe and effective in treating painful~     diabetic neuropathy.~   "
120644|NCT01475773|"~     Is their a association between the objective and subjective severity of a malocclusion,~     quality of life and self-esteem/personality (as modifier between objective/subjective~     severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare~     motivation and expectations and the objective and subjective severity of the malocclusion on~     the other hand.~   "
120645|NCT01475760|"~     The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in~     reducing serum phosphorus in subjects with chronic kidney disease.~   "
120646|NCT01475747|"~     Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250~     adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is~     designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial~     will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the~     standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death.~     One of the pre-specified secondary outcome is the progression of kidney disease. In this~     ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators~     plan to take advantage of the unique opportunities afforded by the parent study to examine~     issues that are of significant public health importance.~      This is an observational study in SPRINT participants. This study will examine~     mechanistically, the factors affecting the progression of atherosclerosis in CKD.~   "
120647|NCT01475734|"~     This is a stepped glucose clamp study designed to investigate the effect of treatment with~     albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in~     subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be~     given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to~     demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a~     glucose-dependent manner.~   "
120648|NCT01475721|"~     The purpose of this study is to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and~     adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol~     combination is the same as those taking inhaled fluticasone propionate alone.~      ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.~   "
120649|NCT01475708|"~     The investigators will compare the outcome of three groups of erythema migrans patients~     treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and~     with severe symptoms that require lumbar puncture.~   "
120650|NCT01475695|"~     Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose~     of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected~     for a minimum of 14 days following study drug administration. Safety and tolerability will~     be monitored throughout the study. A follow-up visit will occur 7-14 days after study drug~     administration.~   "
120651|NCT01475682|"~     Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing~     cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces~     the risk of cardiovascular morbidity and mortality.~   "
120652|NCT01475669|"~     The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can~     reduce the amount of donor blood products needed during complex cardiovascular surgery, and~     that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo~     infusion during surgery. This will be in addition to the standard treatment, which is donor~     blood or blood products. Placebo does not contain any effective medicine.~      The study is randomised. This means that the likelihood that subjects will get FCH or~     placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the~     study is double blind. This means that neither the subjects nor the study doctor will know~     if FCH or placebo is administered. If necessary, the study doctor can find out which~     treatment the subjects are receiving.~   "
120653|NCT01475656|"~     The purpose of this research study is to learn how well the medication levetiracetam~     (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is~     commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the~     seizures have not been stopped by other medicines. The Food and Drug Administration (FDA)~     has approved the use of levetiracetam for older children (over the age of 4) but not for~     infants. Even though it is not FDA approved for this age group, doctors at Cincinnati~     Children's use the medicine as a second drug in babies whose seizures are not stopped by~     phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to~     treat seizures in babies, so researchers are trying to study other medicines.~      In this study, the investigators are looking at how well levetiracetam stops or slows down~     seizures in babies. The investigators are also studying the blood levels of levetiracetam to~     learn more about how the medicine is processed by the body and what level of medicine in the~     body works to stop seizures. The investigators are checking labs before and after giving the~     dose to make sure the medication does not cause any changes in blood counts, kidney~     function, or liver function. The investigators are following all of the babies in the study~     after hospital discharge to see if the parents notice any side effects of the medication.~     Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati~     Children's at 6 months of age for a visit with a neurologist and a neonatologist and~     developmental testing.~   "
120656|NCT01475617|"~     Approximately 33% of the US adult population can be classified as obese based on body mass~     index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed~     every year for the treatment of clinically severe obesity. Roux-en-Y gastric bypass (RYGB)~     is the most common bariatric procedure performed in the United States and has both~     restrictive and malabsorptive components. Despite the success of this procedure in creating~     long lasting weight loss, vitamin and iron deficiencies are common and can lead to~     significant morbidity if not appropriately addressed. Despite the American Association of~     Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic &~     Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation~     recommendations, there has been very little prospective research conducted to assess the~     efficacy and compliance of these micronutrient interventions.~      This prospective randomized controlled clinical study will evaluate the efficacy of a novel~     vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative~     bariatric patients.~   "
120657|NCT01476813|"~     dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF~     in COPD patients.~   "
120658|NCT01476800|"~     The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose~     ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone~     and in combination with ketoconazole in healthy adult volunteers.~   "
120659|NCT01476787|"~     The purpose of this study is to evaluate the effect of the combined treatment of~     lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase~     the length of response compared to the available standard combination chemotherapy treatment~     for Follicular Lymphoma.~   "
120660|NCT01476774|"~     This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group,~     multi-center, safety and efficacy study.~   "
120661|NCT01476761|"~     The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device~     in patients requiring the transection, resection or anastomosis of gastrointestinal tissue~     in a post-market approval study.~   "
120662|NCT01476748|"~     The purpose of this study is to find out how much a trocar might slide during a typical~     laparoscopic hysterectomy. We also want to find out if there is a difference between how~     much three commonly used trocars slide and if a device called LaproStop has an effect on the~     slippage.~      Patients will be randomly assigned into the different trocar groups. After this assignment~     has been made, we will then assign the Laprostop to one of the two trocars by chance.~   "
120663|NCT01476735|"~     This is a prospective, randomized, single-blind study designed to evaluate the influence of~     individual approach on bowel preparation quality for colonoscopy. The investigators compare~     split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified~     split-dose PEG regarding predictors of inadequate preparation for colonoscopy.~   "
120664|NCT01476722|"~     The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting~     solution in silicone hydrogel and soft contact lens wearers.~   "
120665|NCT01476709|"~     Rationale: evaluate the potential of the photonic needle (photonic needle technology) to~     discriminate tissues that are relevant to recognize during intraforaminal (transforaminal)~     epidural injection on lumbar level.~      Objective: The primary objective of this study is to investigate the potential of the~     photonic needle to discriminate between correct and incorrect placement of the needle tip in~     the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced~     fluoroscopy. The secondary objectives are to investigate the differences in the optical~     signals obtained with the photonic needle at a set of different pre-defined positions (M1,~     M2 and M3) encountered along the needle trajectory during above-mentioned procedures, and to~     detect potential intravascular positioning of the needle-tip at the target point (M4 -~     blood), Study design: this is a single blind observational study. Study population: Patients~     who have radicular pain on lumbar level, for example caused by disc herniation, and/or~     lateral recessus stenosis and/or radiculopathy eci.~      Main study parameters/endpoints: The main study parameters are: 1) successfully acquired~     diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the~     foramen (the target treatment location) as encountered during image-guided intraforaminal~     injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of~     contrast fluid (gold standard), 3) Certainty score on a 3-point scale (1 = uncertain, 2 =~     certain, 3 = very certain) will be provided by the physician. The type of tissue present at~     the needle tip will be based on the information available from imaging .~      The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra~     obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a~     distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered~     during image-guided intraforaminal injections on lumbar level, 2) successfully acquired~     diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture~     (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above,~     4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction~     angiography images after contrast injection at location M4, confirming vascular penetration~     (gold standard for vessel puncture), 6) Certainty score on a 3-point scale (1 = uncertain,~     2 = certain, 3 = very certain) provided by the physician for assignment of the type of~     tissue present at the needle tip, based on the information available from imaging at M1 and~     at M4.~   "
120666|NCT01476696|"~     The purpose of this study is to determine the correct prasugrel dosage to be given to~     children with sickle cell disease (SCD).~   "
120667|NCT01476683|"~     This study is designed to compare the pharmacokinetics of four products used for treatment~     of acute diarrhea.~   "
120668|NCT01476670|"~     The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and~     carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired~     in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in~     patients with brain tumors is limited to supratentorial tumors. Due to their anatomic~     location, posterior fossa tumors result in obstruction of ventricular outflow, produce~     hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions~     in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa~     surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical~     positions themselves affect systemic hemodynamics which may influence cerebral blood flow;~     with presence of anesthetics further compromising the blood flow to the brain. Understanding~     the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of~     patients and maintenance of intraoperative hemodynamic.~      The aim of this observational study was to evaluate CA and CO2R in patients with posterior~     fossa tumor prior to surgical decompression of the lesion.~   "
120669|NCT01476657|"~     The purpose of this study is to determine the safety, maximum tolerated dose and~     pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.~   "
120670|NCT01476644|"~     Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment~     worsens in subjects with glaucoma.~      Hypothesis 2: Changes in health-related quality of life are associated with changes in~     clinical measures of vision and performance-based measures of visual function.~   "
120671|NCT01476631|"~     Hypothesis 1: Exercise will decrease serum markers in a dose response manner.~      Hypothesis 2: Participants in the 60 minute intervention will have significantly higher~     physical activity levels than those in the 30 minute intervention at three months.~   "
120672|NCT01476618|"~     The purpose of this study is to gather information from VISN 19 Denver VA mental health~     professionals regarding their perspectives of necessary resources to provide best practice~     mental health service to Operation Iraqi Freedom (OIF)/ Operation Enduring Freedom (OEF)~     Veterans. Specifically, this study aims to describe provider perspectives regarding the~     following: a) clinical needs of OIF/OEF Veterans; b) collaboration and referral processes;~     c) barriers to providing optimal treatment to this cohort d) provider needs and resources~     that may improve service delivery to this cohort; e) provider perspectives regarding~     psychiatric outcomes in this cohort; and f) professional satisfaction. Support for this~     study is provided by previous research evaluating Veteran's Administration (VA) needs to~     provide service to OIF/OEF Veterans (Sayer, et al. 2009; Friedmann-Sanchez, et al. 2008).~      The above information will be obtained using semi-structured interview. Hypotheses are not~     provided as this is an exploratory qualitative study.~   "
120673|NCT01476605|"~     While evidence does not identify any conventional therapy as definitive for chronic lateral~     epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support~     rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE.~     The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections~     commonly used in the treatment of moderate-to-severe tennis elbow using clinical,~     biomechanical and radiological outcomes. Data from this study will support a future~     confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In~     support of this goal, the investigators propose the following research questions.~      Does PrT or PRP, compared to waitlist control:~        1. improve pain- and function-dependent, CLE-specific quality of life among adults with~          CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis~          Elbow Evaluation?~        2. improve upper extremity performance among adults with CLE as assessed by a blinded~          assessor using elbow-specific, effort-dependent biomechanical measures of grip strength~          (pain-free and maximal), stiffness, effective mass and damping~        3. improve the radiologic appearance of several pathologic features of CLE as evaluated~          using imaging studies of lateral elbow structures: ultrasound to assess a)~          neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon~          stiffness (acousto-elastic strain gauge technique) using standardized, 0-3 severity~          scales, and d) MRI to assess the overall common extensor tensor tendon disease severity~          using a standardized 0-3 scale?~        4. provide satisfying treatment to subjects as assessed by a treatment satisfaction survey~          and a qualitative exit interview?~   "
120674|NCT01476592|"~     Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has~     been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth~     of tumors in mice. The purpose of this study is to examine the effects of resveratrol and~     Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors~     who take resveratrol for up to three months tolerate the product.~   "
120675|NCT01476579|"~     This study is evaluating the performance of modern CT coronar angiography with low radiation~     technique compared to conventional invasive coronar angiography. The patients recruited will~     already be accepted for invasive coronary angiography based on clinical presentation, ECG~     and biochemical parameters. An all-comers design to avoid selection bias and no additional~     B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to~     rule out significant coronary artery disease with sensitivity > 95 % and negative predictive~     value > 95 % with very low radiation doses.~   "
120676|NCT01476566|"~     This study will explore the possible effect of a tailored educational intervention towards~     general practitioners in Norway, in order to improve the quality of treatment for heart~     failure in general practice.~   "
120677|NCT01476553|"~     A Japanese study showed that the additional use of an Extensive Intraperitoneal Lavage~     (EIPL), i.e. an extensive washing of the abdominal cavity with water, during surgery for~     gastric cancer can lead to a significant increase in survival. However, the study was~     confined to patients in whom upon commencing surgery, free peritoneal tumor cells were~     detected, which is only a small fraction of patients.~      The primary objective of our study is to assess in all patients undergoing removal of the~     stomach and adjacent lymph nodes for stomach cancer, if EIPL can eliminate free peritoneal~     tumor cells which have been present at the beginning of the surgery or after the stomach and~     lymph node removal. Secondary objectives are to assess how often free peritoneal tumor cells~     occur in patients with stomach cancer, how often surgical resection itself leads to a~     release of tumor cells, the safety of the EIPL procedure, and disease-free and overall~     survival of patients undergoing EIPL. Based on the outcome of this japanese study we want to~     test with special laboratory methods why this lavage leads to a better outcome.~      Specifically, the trial will test the hypotheses that a) lymph node dissection causes a~     release of tumor cells in the abdominal cavity, and b) EIPL eliminates free peritoneal tumor~     cells.~   "
120678|NCT01476540|"~     Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest~     mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and~     neurobiology of AN has led to a greater understanding of its underlying pathophysiology,~     although few significant advances in treatment have been made in the last half-century. The~     central features of AN, which include an intense fear of gaining weight, a refusal to~     maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria~     surrounding food, have been linked to dysfunction in key brain structures and circuits. Deep~     Brain Stimulation (DBS) is a neurosurgical procedure that involves the insertion of~     electrodes into structures believed to drive pathological behavior. The procedure is~     approved for the management of movement disorders, such as Parkinson's Disease, and has~     shown promising early results in the management of some psychiatric conditions, such as~     Major Depression. The purpose of this study is to explore the safety and initial efficacy of~     DBS, in patients with treatment resistant AN.~   "
120702|NCT01476228|"~     The main objective of the study is to evaluate the use of EEG in the management and~     follow-up of neuropsychiatric disorders. Secondary objectives are therefore better~     understanding of the pathological activations in neural network during neuropsychiatric~     disorders, their clinical evolution and response to therapies.~   "
120703|NCT01476215|"~     This proof of principle PK study will allow GSKCH to select the most favorable sustained~     release formulation among 3 prototypes to move to the next stage of drug development.~   "
120679|NCT01476527|"~     Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry.~     Although episodes of mania and hypomania define the different types of the disorder, the~     clinical picture is one dominated by depressed mood and agitation. The mainstay of BD~     treatment has thus far been pharmacologic, but many patients remain severely disabled by~     their condition, despite the best available medical treatment. The successful use of deep~     brain stimulation (DBS) in movement disorders, and its promising results in major depressive~     disorder (MDD), has led researchers to consider its use in highly selected refractory cases~     of BD. Evidence form the imaging and circuitry literature suggests that similar underlying~     dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key~     structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose~     a phase I clinical trial to evaluate the safety of DBS in BD.~   "
120680|NCT01476514|"~     Mutations in genes affecting pain transmission start to be known, the investigators are~     investigating a mutation in a glycine channel, which has an influence on pain modulation.~     Pain modulation is the ability of the central nervous system to enhance or diminish the~     sensation of pain. The investigators therefore will test patients and healthy volunteers~     with quantitative sensory tests, basically determining the point at which a stimulation just~     starts to induce pain. These tests are reliable and permit a direct comparison between~     healthy volunteers and patients with the affected glycine gene.~   "
120681|NCT01476501|"~     Diabetes is a life-long disease that is getting more common in Canada. One of the most~     common problems in people with kidney disease is diabetes and low bone mineral density~     (BMD). This can lead to a higher chance for broken bones, infection and life-long health~     problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D)~     in your diet and not having enough sunlight. This is very common in Canada (especially in~     northern Alberta) because winter is very long. Most people also don't eat or drink enough~     foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body~     to make healthy bones. This can mean the only way to get enough Vit D in your body for your~     bones when you have kidney disease is to take some extra vitamin D in a pill. Most people~     are not aware that they have poor bone health until they break a bone. Broken bones can~     really hurt and can prevent a person from being able to walk and take care of themselves.~     Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease~     need to take to prevent them from having low BMD or how often they need to take it. Our plan~     is to study the effect of two ways to take Vit D pills (every day or once a month) on~     overall Vit D status and on bone health in adult patients with diabetes and chronic kidney~     disease and see how this influences their quality of life.~      Hypotheses:~        1. Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result~          in significantly improved overall vitamin D status and improved markers of bone health~          in adult patients with diabetic nephropathy.~        2. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved~          patient adherence and satisfaction with vitamin D supplementation when compared to~          daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone~          health parameters, which will result in an increased quality of life and sense of~          well-being.~   "
120682|NCT01476488|"~     This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable~     pediatric kidney transplant recipients.~      Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and~     after that, the same dose of advagraf will be prescribed. The patients will have another~     pharmacokinetic study of tacrolimus after conversion to advagraf.~   "
120683|NCT01476475|"~     Primary Objective:~        -  The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio~          combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as~          evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants~          treated with metformin.~      Secondary Objectives:~        -  To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:~             -  Glycemic control in relation to a meal as evaluated by post-prandial plasma~               glucose and glucose excursions during a standardized meal test;~             -  Percentage of participants reaching HbA1c <7% or ≤6.5%;~             -  7-point Self-Monitored Plasma Glucose (SMPG) profile;~             -  Body weight;~             -  Insulin glargine dose~             -  Fasting Plasma Glucose (FPG);~             -  Percentage of participants requiring rescue therapy during the 24-week open label~               treatment period;~        -  To assess safety and tolerability of insulin glargine/lixisenatide FRC.~   "
120684|NCT01476462|"~     Development of a second neoplasm (SMN) during or after therapy for childhood acute~     lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In~     this international study we analyze subtypes of SMN in relation to their initial leukemia~     characteristics and treatment, and their subsequent overall survival.~   "
120685|NCT01476449|"~     This study is to see whether treating diabetic retinal swelling with ranibizumab injections~     into the eye monthly is better than treating diabetic retinal swelling with ranibizumab~     injections into the eye less frequently.~   "
120686|NCT01476436|"~     Low carbohydrate diet may influence the plasma lipid levels.~   "
120687|NCT01476423|"~     This observational registry is conducted in Europe, Asia, Africa and the United States of~     America (USA).~      The purpose of the registry is to evaluate the efficacy and safety of activated recombinant~     human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during~     invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or~     present refractoriness to platelet transfusions. Attention will be directed towards~     complications related to thrombo-embolic events and concomitant medications especially~     antifibrinolytics.~   "
120688|NCT01476410|"~     This phase II trial studies how well giving brentuximab vedotin together with combination~     chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin~     lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block~     cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such~     as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and~     dacarbazine together may kill more cancer cells.~   "
120689|NCT01476397|"~     This is a growth study of full-term, formula-fed infants randomized to receive a partially~     hydrolyzed whey protein formula with and without probiotics for the first four months of~     life. It is hypothesized that there will be no difference in growth between the two groups.~   "
120704|NCT01476202|"~     This study is designed to assess the ability of the mint nicotine mouth strip to relieve~     provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.~   "
120705|NCT01476189|"~     A repeat dose pharmacokinetic study investigating two paracetamol formulations~   "
120706|NCT01476176|"~     This PK study is designed to show bioequivalence between the study treatments.~   "
120690|NCT01476384|"~     Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to~     the loss of functional capacity and an increased risk of developing chronic metabolic~     disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus~     type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of~     insulin resistance and relative insulin deficiency. It has become clear that amongst its~     many actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric~     oxide dependent vasodilation is physiologic and dose dependent. Recent data suggest that~     insulin's metabolic and vascular actions are closely linked. This also means that an~     increase in microvascular perfusion following food intake is more resistant to postprandial~     insulin release. This physiological process is brought into prominence with increasing age,~     and even more in type 2 diabetics, and contributes to diminishing glycaemic control. In the~     present study the investigators will investigate the impact of postprandial insulin release~     on microvascular recruitment in the oral cavity.~   "
120691|NCT01476371|"~     The purpose of this study is to determine the effectiveness, with respect to symptoms and~     systemic inflammatory level, of mindfulness-based group treatment compared with normal~     treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is~     that mindfulness group-treatment 1) will be at least as effective as normal treatment in~     reducing psychiatric symptoms; 2) will increase quality of life compared with normal~     treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce~     inflammation-related markers. The study will be conducted at primary care centers in Skåne,~     Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric~     symptoms, quality of life, and health (as rated by the patients themselves) as well as~     inflammatory markers.~   "
120692|NCT01476358|"~     Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6~     months of age, but has a null or detrimental effect when given between 1-5 months. Studies~     of neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations~     might result from immunological interactions between VAS and vaccines. The potential~     efficacy of NNVAS is being retested in 3 large new intervention trials with mortality as~     endpoint. Complementary mechanistic studies in animals and in human infants in The Gambia~     (this proposal) and Bangladesh have been commissioned to run in parallel.~      The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the~     early ontogeny of human immune development. Neonates, recruited through a peri-urban clinic~     in The Gambia, will receive either 50,000 International Units (IU) VAS orally within 48~     hours of birth (intervention group, n=100) or a placebo (control group, n=100). Male and~     female neonates will be randomized separately at enrolment for later analyses by sex. All~     infants will be followed up from birth to age 1 year. A broad panel of immunological~     outcomes will examine whether NNVAS: a). normalises thymic development (thymic index by~     ultrasound); b). skews mycobacterial and recall antigen responses towards a Th2 profile; c).~     diminishes Th1 and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the~     tuberculin skin test (TST) response; e). causes increased innate immune reactivity; f).~     increases the frequency of circulating regulatory T cells (Tregs) expressing gut homing~     receptors; g). enhances B cell immune responses after routine vaccination (increase of B~     cell numbers and activation status); h). increases circulating IgA in mucosal immune~     compartment, especially oral polio vaccine (OPV) specific IgA post-vaccination; i).~     decreases bacterial translocation, by improving mucosal barrier function; and j). decreases~     markers of infection or inflammation. Growth and morbidity will also be assessed.~   "
120693|NCT01476345|"~     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of~     LY2963016 compared to those of basal insulin. The study will also gather information on the~     safety and tolerability of LY2963016 in healthy participants.~      Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout~     period). There are 4 study periods.~   "
120694|NCT01476332|"~     The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics~     of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.~   "
120695|NCT01476319|"~     This study is planning to develop the audiovisual videos and determine whether educational~     videos are superior to routine discussion for informing patients in the emergency department~     (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy.~     Eligible patients will be approached when patients will be scheduled and waiting for~     receiving percutaneous cholecystostomy in the emergency department.~   "
120696|NCT01476306|"~     The investigators will conduct a two-arm, parallel group, randomized comparative~     effectiveness study across two sites to increase specialty access and improve care for~     individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism~     will be recruited from Johns Hopkins University and the University of Rochester~     (approximately ten from each site). They will then be randomized to either continue their~     usual in-person care with a specialist or to receive care with their specialist via~     telemedicine in their home. Following an in-person baseline/screening visit, approximately~     ten individuals in the first arm (virtual house calls) will receive three visits with a~     movement disorder specialist via telemedicine (using web-based video conferencing) in their~     home. Approximately ten individuals in the second (control) arm will receive three in-person~     visits at an academic medical center with the same specialists. Approximately two weeks~     after the completion of each clinical visit, a nurse or coordinator will call the patient to~     call to address any questions or ensure appropriate understanding of the recommendation (for~     both telemedicine and control arms). Overall, the study - consistent with a national~     priority for comparative effectiveness research - will compare the use of telemedicine to~     manage Parkinsonism to usual care.~   "
120697|NCT01476293|"~     The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects~     receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an~     indication that the PIV is leaking fluids outside of the vascular system. The study~     hypothesis is to demonstrate that changes in the optical signals of the non-invasive~     monitoring medical device will detect infiltration and extravasation events.~   "
120698|NCT01476280|"~     Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor~     antagonists and this randomized double blind study was designed to compare efficacy of~     ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator~     hypothesized that palonosetron would have stronger and longer lasting antiemetic effect~     compared with ramosetron and evaluated the patients for the first 48 hours after surgery.~   "
120699|NCT01476267|"~     This single center, open-label, non-randomized, one-treatment, one-period study will~     evaluate the metabolic profile and the safety of a single oral radiolabeled dose of~     dalcetrapib in male healthy volunteers.~   "
120700|NCT01476254|"~     The purpose of this study is to describe the magnitude of respiratory complications after~     laparoscopic hysterectomy and cholecystectomy.~   "
120708|NCT01476150|"~     1. To establish a BMD reference database of Beijing's urban population, China.~        2. To determine the prevalences and risk factors of osteoporosis and osteopenia in~          Beijing's urban population, China.~        3. To describe the 25OHD level and estimate the prevalence of vitamin D insufficiency and~          deficiency of Beijing's urban population, China.~        4. Estimation of the prevalence of osteoporotic fracture (vertebral) in over age of 60 of~          Beijing's urban population, China.~   "
120709|NCT01476137|"~     The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor~     can be given in combination and if the combination is effective treatment for patients with~     solid tumors, including breast cancer and endometrial cancer, and for patients with multiple~     myeloma.~   "
120710|NCT01476124|"~     This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or~     gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn~     alone and in combination as well as the tolerability of morphine administered with GEn. The~     dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be~     administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a~     controlled release formulation of morphine will be given. Blood samples for evaluation of~     gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic~     effect of co-administering both treatments will be assessed using visual analog scales for~     somnolence/sedation, dizziness and nausea.~   "
120711|NCT01476111|"~     This study will examine specific biomarkers in primary invasive breast cancer and explore~     their correlation with patient outcome following standard neoadjuvant treatment.~   "
120712|NCT01476098|"~     This study is designed to loook at the affect of oral SB-705498 on cough following an~     inhaled capsaicin challenge~   "
120713|NCT01476085|"~     This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid~     ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in~     patients with Non Hodgkin's Lymphoma.~   "
120714|NCT01476072|"~     An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to~     obtain a consistent standard of measurement of muscle metabolism while maintaining an~     acceptable level of subject comfort and use optimised method to measure and compare~     metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control~     subjects~   "
120715|NCT01476059|"~     Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of~     children aged between 6 and 14 years old with persistent moderate or severe asthma,~     receiving the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.~      ADERE PROJECT (Pediatric)~   "
120716|NCT01476046|"~     The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated~     after dosing. The study will also investigate how GSK1995057 is taken up, metabolised~     (chemically broken down), distributed through the body and excreted, and what some of the~     effects of the study drug are.~   "
120717|NCT01476033|"~     The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice~     powder concentrate on oxidative stress, inflammation and blood flow before and post exercise~     in overweight, middle-aged, women.~      Main hypotheses (H1):~        -  The nutraceutical has an impact on oxidative stress reduction.~        -  The nutraceutical has an impact on inflammation.~        -  The nutraceutical has an impact on blood flow and microcirculation.~        -  Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation~          markers.~        -  Walking exercise for 30 minutes has an impact on blood flow and microcirculation~        -  The combination of nutraceutical supplementation + walking exercise for 30 minutes has~          an impact on oxidative stress- and inflammation markers, and on blood~          flow/microcirculation.~   "
120718|NCT01476020|"~     The ITALIC PLUS Trial was designed with the objective of extending to other countries the~     enrollment of patients into the ITALIC trial initially conducted in France, in order to~     achieve statistical significance by pooling the data of both trials.~   "
120719|NCT01476007|"~     Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin~     B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients~     with Cobalamin Deficiency.~      Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the~     primary healthcare setting (Madrid Region).~      Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent.~     Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).~      Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary~     outcome variables: Adverse events. Adherence measurement of treatment. Health related~     quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables:~     Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and~     physical examination) and blood parameters. Drugs consume.~      Causes of all losses and withdrawals. Number of patients (age and gender) who declined to~     participate.~      All data (excluding patient identification data) will be record in an electronic database.~      Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.~      Analysis: Descriptive analysis (screening phase). Baseline comparison of the two~     intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life.~     Adherence measurement of treatment.~   "
120720|NCT01475994|"~     This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to~     assess the effect of challenges with dactylis glomerata pollen in an environmental challenge~     chamber on dermal symptoms in patients suffering from atopic dermatitis.~      After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for~     biomarker assessments. The severity of atopic dermatitis will be rated with the SCORing~     Atopic Dermatitis (SCORAD), with the objective SCORAD and with the assessment of itch and~     sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist)~     on each day including baseline assessments.~   "
120721|NCT01475981|"~     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of~     ascending single oral doses of JTK-853 administered under fasted or fed conditions in~     healthy male subjects.~   "
120752|NCT01475383|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     compound designated PF-03654746 compared to placebo in the treatment of adults with~     Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in~     adults with Tourette's Syndrome.~   "
120722|NCT01475968|"~     The purpose of this study is to examine the acute health effects of concentrated ambient~     ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without~     lifestyle changes or medical intervention these patients are at considerable risk for~     developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM~     and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure~     pre-, post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population~     will result in changes in vascular and endothelial response as assessed by flow-mediated~     dilatation of the brachial artery and various heart rate variability and blood endpoints.~     This study and similar studies of susceptible populations are needed to provide the EPA with~     information regarding the health risks associated with ambient levels of UF PM.~   "
120723|NCT01475955|"~     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and~     effective in the treatment of actinic keratosis when applied to broad areas on the face and~     scalp for 1, 2 and 3 hours.~   "
120724|NCT01475942|"~     The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile~     levels of elderly subjects.~   "
120725|NCT01475929|"~     The purpose of this study is to analyse the effect of probiotic supplement on symptoms of~     irritable bowel syndrome.~   "
120726|NCT01475916|"~     Asthma is the most common chronic disease in childhood [1]. The advantage of an educational~     program in a global strategy of care has been established in asthma (decrease of nocturnal~     asthma, absence from work and school) [2, 3]. Therapeutic education of the patient permits~     the reduction of the rate of hospitalization, of the rate of emergencies visits and~     non-programmed visits. [3].~      The WHO defines quality of life as an individual's perception of its place in existence, in~     the context of culture and value system in which he lives, in relation to its objectives,~     expectations, standards and concerns [4]. The basic point of this concept is the notion of~     perception, emphasizing the perspective of the person. It is a broad concept affected in a~     complex way by the subject's physical health, psychological state, level of independence,~     social relationships, and its relations with its environment. In the field of health,~     analyzing the quality of life includes objective aspects (living conditions, functional~     health) and subjective aspects (satisfaction, happiness, well-being) that allow to~     understand the situation of people in whole.~      As defined by the WHO-Europe report published in 1996 [5], the therapeutic education aims to~     help patients acquire or maintain the competencies they need to best manage their lives with~     a chronic disease.~      It is entirely part of the management of the patient. It includes organized activities~     designed to make patients aware and informed of their disease, of care organization and~     hospital procedures, and the behaviors related to health and disease. This is to help them~     and their families understand their illness and treatment, to work together and to gain~     autonomy from their disease in order to help maintain and improve their quality of life [6].~      However, studies demonstrating the effectiveness of therapeutic patient education are still~     very few, especially in children. The need for prospective studies including the evaluation~     of the impact on quality of life was highlighted in a recent Cochrane meta-analysis [7]. It~     seems interesting for the authors to assess the improvement of the quality of life after~     educational sessions in children at school-age.~   "
120727|NCT01475903|"~     Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid~     obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two~     types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a~     purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible~     procedure, which associates restriction and mild malabsorption. Longitudinal sleeve~     gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More~     recent, this technique is recognized in France by the High Authority of Health since 2008,~     consisting of fundus and greater curvature resection, removing 75 % the gastric volume,~     leaving a narrow gastric tube or sleeve.~      Although malabsorption does not occur in most bariatric procedures, micronutrient~     deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies~     concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have~     minor effects on normal physiological digestive processes but could lead to vitamin~     deficiency secondary to decreased nutrient intake and a tendency towards avoidance of~     certain types of food due to intolerance. Studies of nutritional complications of bariatric~     surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no~     longer performed in France. The nutritional impact of LSG remains to be evaluated. To date,~     data concerning evaluation of nutritional status from patients who underwent LSG are almost~     non-existent. Considering this type of surgical procedure, the investigators expect to~     observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely~     restrictive intervention, LSG consists of gastric fundus resection which is the site of~     intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease~     of hydrochloric acid production and potential vomiting caused by gastric resection can alter~     iron absorption.~      In view of the increasing popularity of this surgical technique, assessment of the~     nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.~   "
120728|NCT01475890|"~     The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in~     children, adolescents and young adults with Human Immunodeficiency Virus and acquired~     immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind,~     placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on~     evidence from the Vit D Dose Finding Study-IRB 09-007332.~   "
120729|NCT01475877|"~     This study will compare the effect of two topical non-steroidal antiinflammatory agents to~     control pain after photorefractive keratectomy (PRK) eye surgery.~   "
120730|NCT01475864|"~     The current standard of care for bile duct stone are endoscopic sphincterotomy and stone~     extraction. Placement of plastic stents is an option for incomplete biliary stone clearance.~     This study will use the CSEMS in patients with complex biliary stones who failed stone~     extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing~     measure that allows more successful subsequent stone clearance. However, their use in benign~     condition has been limited especially for biliary stone removal. The purpose of this study~     is to determine the feasibility, safety, easy removability, stent-stone formation rate, and~     migration rate of CSEMS for complex biliary stones.~   "
120731|NCT01475851|"~     The purpose of this study is to evaluate the efficacy and safety of once-daily treatment~     with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor~     response to other drugs.~   "
120732|NCT01475838|"~     This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/~     emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR)~     relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV)~     plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at~     Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate~     the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.~   "
120753|NCT01475370|"~     The purpose of this study is to assess the safety of OCV-501 in patients with AML who~     completed the Study 311-10-001 and were judged that there was no relapse by any inspections~     in the end of the study.~   "
120818|NCT01474525|"~     This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose~     telemonitoring system against usual care in women with gestational diabetes mellitus (GDM)~     or type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can~     improve glycemic control in patients, assessed using the mean blood glucose during gestation~     as the primary outcome measure.~   "
120733|NCT01475825|"~     Primary objective:~      Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in~     patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as~     low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary~     heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence~     of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different~     mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly~     versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo.~      Secondary Objectives:~        -  Determine whether there are qualitative differences between the safety profiles of the~          2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160~          mg/dL and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort~          2), and the overall study population~        -  Determine whether there are qualitative differences between the tolerability of the 2~          dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population~        -  Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1,~          Cohort 2, and the overall study population~        -  Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic~          lipid levels in Cohort 2 compared to placebo~        -  Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients~          with FH and inadequately controlled LDL-C who complete the primary efficacy assessment~          visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label~          Continuation Period~   "
120734|NCT01475812|"~     Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow~     limitation usually progressive and associated with inflammatory response of lung noxious~     particles. During a physical activity chronic obstructive pulmonary disease patients may~     develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased~     activity performance. The investigators hypothesize that some specific activities of daily~     living induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure~     dynamic lung hyperinflation and its influence in dyspnea perception in moderate and severe~     chronic obstructive pulmonary disease patients after activities of daily living. Methods:~     The investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen~     saturation, heart rate and respiratory rate in 19 chronic obstructive pulmonary disease~     (COPD) patients. These measurements were taken at rest and after daily living activities~     (such as going up and down a set of stairs, going up and down a ramp and sweeping and~     mopping a room).~   "
120735|NCT01475604|"~     The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF),~     a type of electromagnetic field treatment with the Ivivi Torino II for reducing~     post-operative narcotic use in patients recovering from Total Knee Arthroplasty.~   "
120736|NCT01475591|"~     The aim is to evaluate effects of early individually tailored web-based multimodal~     rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary~     health care. The aim is also to study if this early web-based pain rehabilitation program is~     more cost-effective than only multimodal rehabilitation. Randomization will be done at each~     primary health care centre after screening to 1) Multimodal pain rehabilitation with~     web-based education and coaching support or 2) multimodal pain rehabilitation. The~     investigators suggest a clear rehabilitation chain where a web-based program is~     developed,evaluated and ready to implement if it shows positive effects on work-ability~     and/or is cost-effective. The research and implementation will be performed in a close~     cooperation with Luleå University of Technology.~   "
120737|NCT01475578|"~     The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on~     clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study~     structure planned in this project, the dosage and study structure of phase III study can be~     confirmed.~   "
120738|NCT01475565|"~     The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with~     PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy~     complications. It is unknown if there are factors that may predict which women are more at~     risk.~      The goal of this study is to evaluate the risk factors of gestational diabetes, such as~     dietary and physical activity factors, race, and how the body handles its own hormones~     during pregnancy. Our long term goal is to contribute in finding ways to successfully~     prevent gestational diabetes.~   "
120739|NCT01475552|"~     The researchers aimed to investigate the effect of point-of-care platelet function assay on~     the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.~      All patients who are supposed to undergo coronary angiography were loaded with clopidogrel~     (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent~     after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP~     (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or~     control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are~     followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are~     assessed at 1 month.~   "
120740|NCT01475539|"~     The purpose of this study is to generate data to support the registration extension of~     IMOVAX Polio to be used in a sequential vaccination.~      Primary objective:~        -  To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral~          Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2)~          poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of~          seroprotection rate 28 to 42 days after the third dose of the primary vaccination~          series.~      Secondary objectives:~        -  To evaluate the safety profile of the investigational vaccines after each~          administration in each group.~        -  To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3)~          before the first dose and 28 to 42 days after the third primary series dose of vaccine~          in each group.~        -  To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and~          3) after the third primary series dose administration, at 18 months of age in each~          group.~   "
120783|NCT01474980|"~     This is a retrospective study that follows the clinical evolution, the pregnancy and the~     post-partum perioad of female patients with Congenital Myasthenic Syndrome.~   "
120819|NCT01474512|"~     This study will assess the safety and efficacy of LY2439821 compared to placebo in~     participants with moderate to severe, chronic plaque psoriasis.~   "
120741|NCT01475526|"~     El Valor de Nuestra Salud [The Value of Our Health] is a 5-year study (2010-2014) involving~     grocery stores in San Diego County funded by the National Cancer Institute. The purpose of~     the study is to determine whether an in-store program can promote healthy foods through~     grocery stores. Sixteen stores in San Diego County will participate in El Valor de Nuestra~     Salud. The stores that participate in this study will be randomly assigned to either the~     intervention (program and evaluation) or control (evaluation only) group. We will test~     various strategies to promote healthy food shopping among customers of small-to-medium size~     Latino/Hispanic grocery stores. These strategies include changes to the store environment,~     food marketing efforts, and training of sales associates. Our evaluation protocol will~     determine whether the project is successful at improving aspects of the store and the~     employees, as well as whether customers shop for and eat healthier food products. The~     primary aim of the study is to evaluate the impact of the El Valor de Nuestra Salud~     intervention on consumption of fruits and vegetables among store customers.~   "
120742|NCT01475513|"~     Birth control pills are the most commonly used method of birth control. The purpose of this~     research study is to examine whether birth control pills change heart disease risk and how~     the body handles blood sugar when given to different women.~   "
120743|NCT01475500|"~     This screening study will address the lack of molecular strategies for the early detection~     of lung cancer and integrate those with epidemiological and imaging strategies.~      The hypothesis is that the repeated measure of biomarkers of risk obtained from the~     molecular analysis of biological specimens including those from bronchoscopy (bronchial~     brushings and biopsies) may contribute to the refinement of high-risk populations and allow~     an earlier clinical diagnosis.~      The goal of the investigators study is to provide screening for lung cancer in a high-risk~     population. In this prospective cohort it will be tested whether repeated measure of~     biomarkers of risk allows early detection of lung cancer.~   "
120744|NCT01475487|"~     Inability to provide oxygen to the patient remains the most fearful anesthesia-related~     mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an~     anesthesiologist, who is encountered with this situation. The current method of~     cricothyrotomy relies on digital palpation (DP). Several patient populations, including~     morbidly obese, short neck, radiation to and previous neck surgeries, have difficult~     landmarks for this procedure. Ultrasound (US) technology has been used in the past to~     visualize landmarks for cricothyrotomy, but there is no study which has examined the role of~     ultrasound in patients who have obscure landmarks. There is no data related to the~     performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed~     to determine the outcomes of CT performed on human cadavers using US-guidance, compared to~     conventional DP, of anatomical landmarks. In particularly, complication rates, failure to~     cannulate, correct placement of the device and insertion time of CT were assessed.~   "
120745|NCT01475474|"~     The purpose of this study is to determine whether the use of the Renew Insert is effective,~     tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.~   "
120746|NCT01475461|"~     B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2~     diabetes~   "
120747|NCT01475448|"~     The goal of this project is to understand the effect of regular practice of long distance~     running on the posture and movement control of older adults.~      For such, the investigators will conduct an experiment with longitudinal design where~     sedentary elderly individuals will be trained in long distance running for about 4 months.~   "
120748|NCT01475435|"~     Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders~     that have a major impact on the health and well being of millions of individuals worldwide.~     Periodontal diseases are among the most common diseases in humans, therefore, if the~     presence of periodontal diseases plays any role in overall systemic health, the public~     health impact may be substantial. An important factor that can be involved in the~     progression of the periodontal disease is the production of Reactive Oxygen Species (ROS).~     The imbalance between oxidative stress induced by ROS and the concentrations (or activity)~     of the antioxidant may result in tissue damage. The ROS induce the activity of lipid~     peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect~     the severity of the periodontal disease and it may offer the basis for a patient specific~     diagnostic test for periodontitis and could have therapeutic significance. The aim of this~     study is to investigate quantitatively the levels of oxidative stress markers~     (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival~     crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis~     and periodontally healthy individuals, and systematically healthy individuals with~     generalized chronic periodontitis and periodontally healthy individuals, before and after~     periodontal treatment. Unstimulated whole saliva will be collected for 5 min as well as GCF~     of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2~     periodontally healthy individuals as controls, 25 systematically healthy individuals with~     generalized chronic periodontitis and 25 periodontally healthy individuals before and after~     treatment. The following clinical parameters will be evaluated: probing pocket depth,~     probing attachment level, plaque index and the gingival index. The activity of stress~     markers in saliva and GFC will be analyzed by spectrophotometry. Adequate statistical~     analysis will be carried out with a p-value set at p < 0.05.~   "
120749|NCT01475422|"~     The self-monitoring of capillary blood glucose is part of the package of interventions in~     diabetes mellitus and an effective therapeutic strategy for the adequate control of the~     disease; and the continuing education of people with DM is recognized as one of the goals to~     delay the complications arising from chronic disease and alleviate the symptoms of~     hypoglycemia and hyperglycemia.~   "
120750|NCT01475409|"~     The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor~     necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly~     recommended. Tuberculin skin test (TST), universally used for this purpose, lacks~     sensitivity and specificity. The novel screening tools, including QuantiFERON-TB Gold~     In-Tube (QFT-GIT), have shown a higher specificity compared to TST, but their feasibility in~     the setting of immunosuppression remains unclear. Aims of this study were to investigate the~     performance of QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis~     factor (TNF) therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment~     with biologics to assess whether dynamic changes in interferon (IFN)-gamma levels may be~     helpful in identifying reactivation of LTBI or cases of newly acquired tuberculosis.~   "
120751|NCT01475396|"~     Physical activity is thought to increase overall body functions and to decrease~     cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise~     could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80~     years old healthy subjects take part in a prospective study with regular sports activity~     during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome~     measures, further investigations include MRT of the head, lactat- and other physical~     measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is~     suggested to predict better cognitive performance.~   "
120754|NCT01475357|"~     Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to~     address a widespread health problem in the pediatric cardiac infant population - poor~     postnatal growth - through a collaborative effort between pediatric cardiology,~     cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that~     term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk~     feeds in the pre-operative period will show improved gut function than neonates who were~     strictly NPO (nothing by mouth) in the pre-operative period.~   "
120755|NCT01475344|"~     Severe traumatized patients with visible significant bleeding and/or with clinical signs of~     internal significant bleeding treated by an emergency doctor of the helicopter service or~     the ground team will be enrolled in the study (inclusion- and exclusion criteria: see~     above). If a patient meets the inclusion criteria and is recruited for the study, FGTW or~     placebo administrated over 5 min/vial:~      Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg~      No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)~      Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g~   "
120756|NCT01475331|"~     The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or~     without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic~     ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.~   "
120757|NCT01475318|"~     By using the combination of mifepristone (anti-progestin), misoprostol (progstanglandin~     which stimulates uterine contraction), and letrozole (aromatise inhibitor which reduces~     estrogen production), the abortion process will be more effective.~   "
120758|NCT01475305|"~     The primary goal is to evaluate the suitability of the Respiratory Syncytial Virus (RSV)~     challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult~     subjects for the reduction in the incidence of RSV through 12 days post-RSV challenge with~     the RSV virus.~   "
120759|NCT01475292|"~     RV568 is being developed as a possible treatment of diseases such as smoking related lung~     disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.~      The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose~     strengths of RV568 and a placebo will be tested in this study, which will be given by~     inhaling a liquid suspension from a nebuliser once a day for 2 weeks.~   "
120760|NCT01475279|"~     The purpose of this study is to evaluate the potential effect of Dantonic on the~     steady-state pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety~     of the co-administration of Dantonic and warfarin.~   "
120761|NCT01475266|"~     The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle~     invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were~     randomized into either an EO9 or placebo group after TURBT.~   "
120762|NCT01475253|"~     The purpose of this study is to determine if LiRIS®, an investigational drug-delivery~     system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is~     inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is~     removed via cystoscopy.~   "
120763|NCT01475240|"~     Use of some protease inhibitors is associated with elevations of a blood pigment called~     bilirubin. This may occasionally lead to yellowing of the eyes (scleral icterus) or~     jaundice, but in the general population bilirubin elevations have been shown to have~     antioxidant and anti-inflammatory properties that could be associated with reduced risk of~     cardiovascular or other disease events.~      Inflammation may also be relevant to neurocognitive impairment in HIV (Human~     Immunodeficiency Virus) infection hence elevations of bilirubin may also be protective~     against neurocognitive impairment.~      The purpose of this study is to evaluate the impact of hyperbilirubinemia (HBR) on risk of~     heart and renal diseases, and cognitive function.~   "
120764|NCT01475227|"~     The study is being conducted as the most common side effect of the HIV drug atazanavir~     (taken with ritonavir) is hyperbilirubinaemia. Bilirubin is a normal waste product from the~     body and gets broken down in the liver so it can leave the body through the gut. Atazanavir~     slows the breakdown of this chemical, which can cause jaundice (yellowing of the skin)~     and/or scleral icterus (yellowing of the eyes). This is completely harmless; in fact up to 1~     in 10 of the UK population have an inherited condition that causes the same yellowing.~     However, some patients don't like this side effect and it is the commonest reason for~     switching off the drug.~      A study in people with Gilberts syndrome (the inherited condition that causes the same~     changes in the chemical bilirubin) showed that a mineral supplement (zinc sulphate) reduced~     the levels of bilirubin in the blood. The aim of this study is to see if using zinc~     supplements can achieve the same effect in patients with high bilirubin due to atazanavir~     use.~   "
120765|NCT01475214|"~     With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as~     a result of declining renal function and ingestion of acid-producing diets. There is~     extensive evidence that severe metabolic acidosis causes bone and muscle loss, but the~     impact of the chronic, mild acidosis on bone and muscle in older individuals has not been~     established. In a recent study, administration of a single dose of bicarbonate daily for 3~     months significantly reduced urinary excretion of N-telopeptide (NTX), a marker of bone~     resorption and urinary nitrogen, a marker of muscle wasting and improved muscle performance~     in the women but not the men. These and other data support a potential role for bicarbonate~     as a means of reducing the musculoskeletal declines that lead to extensive morbidity and~     mortality in the elderly. Before proceeding to a long-term bicarbonate intervention study,~     however, it is important to identify the dose of bicarbonate most likely to be optimal and~     to characterize the subjects who benefit most from it. This double blind, placebo~     controlled, dose-finding study will evaluate the effects of placebo and two doses of~     bicarbonate on urinary NTX and nitrogen excretion and on lower extremity performance over a~     3 month period in 138 men and 138 women, age 60 and older. Changes in urinary excretion of~     NTX and nitrogen and in selected measures of lower extremity performance will be compared~     across the three groups. The safety and tolerability of the interventions will also be~     evaluated. This investigation should provide needed information on the appropriate dosing~     regimen for men and women and on the study population that should be enrolled in a future~     bicarbonate intervention trial to assess the long-term effects of this simple, low cost~     intervention on important clinical outcomes including rates of loss in bone and muscle mass,~     falls, and fractures.~   "
120784|NCT01474967|"~     Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and~     causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by~     insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this~     study was to assess the effects of metformin on menstrual disorders and lipid profile in~     women with PCOS in bandarabbas.~   "
120820|NCT01474499|"~     This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol~     rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients~     with constipation.~   "
120766|NCT01475201|"~     Many people with diabetes and/or high blood pressure (hypertension) are not very active.~     When people are more active, they can reduce the chances of having a heart attack or stroke.~     Walking more is a cheap and effective way to be more active and to lower the risk of heart~     attacks and strokes. The problem is that many people do not walk enough! The investigators~     will study if people with diabetes and/or hypertension walk more when the doctor gives them~     a prescription with the number of steps they should be walking every day. The investigators~     will compare this group, called 'active', to another group, called 'control', in which~     doctors and their patients do what they usually do, over a period of one year.~      The investigators will measure the number of steps the investigators walk everyday with a~     step counter or pedometer. In the step count prescription group, the doctors will give to~     the 'active' group a pedometer, a step count record book, and step count prescriptions. The~     overall goal is to gradually increase daily steps. The speed of the increase in step count~     will be slower for less active people. At each visit the doctor will look at the step count~     record book. The doctor will then give a new step count prescription to the patients.~     Patients of the two groups will see their doctor about four times during the year, which is~     how often they usually see their doctor. At the end of one year, the investigators will see~     the difference in the hardness of the arteries between the 'active' and the 'control'~     groups, using simple and safe measurements, similar to ultrasound in pregnant ladies. People~     with hard arteries are more likely to have a heart attack or stroke.~      The investigators suspect that patients who get the step count prescriptions will walk more~     and their arteries will be less hard than the control group. Our study will help find out if~     this is true. In that case, doctors should take the time to prescribe steps for all their~     patients with diabetes and/or hypertension.~   "
120767|NCT01475188|"~     The purpose of this study is to determine whether specific subcutaneous immunotherapy~     affects fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70~     in regulatory T lymphocytes.~   "
120768|NCT01475175|"~     The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective,~     multi-center, non-randomized investigational study designed to compare indices of cardiac~     function at device settings optimized using the investigational Adaptive CRT (aCRT)~     algorithm versus nominal programming. The comparison will be performed during rest, atrial~     pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study~     (NTC00980057) being conducted in Europe.~   "
120769|NCT01475162|"~     This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of~     steroid refractory acute Graft versus host disease (GVHD).~   "
120770|NCT01475149|"~     This 12 week study will observe patients with and without systemic lupus erythematosus who~     have persistent antiphospholipid antibodies in the blood who are starting a medicine called~     hydroxychloroquine. It will measure if these patients have a change in a blood test called~     the annexin A5 resistance assay over that 12 week period.~   "
120771|NCT01475136|"~     This study will explore how liver impairment effects blood levels of LY2140023 (a prodrug)~     and its active metabolite LY404039.~   "
120772|NCT01475123|"~     Nicorandil is potentially effective to prevent cardiovascular events in patients with~     coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to~     prospectively investigate whether nicorandil is effective in reducing the incidence of~     cardiovascular events in patients with CAD on hemodialysis.~   "
120773|NCT01475110|"~     The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study~     of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment~     will include all patients who started Nilotinib between January 2005 and December 2012.~     Patients will be followed for 4 years since treatment start. After this time, survival data,~     disease status and treatment will be recorded at 6-months-interval. This study will help the~     definition of guidelines for a proper management of Nilotinib in any-phase CML patients.~   "
120774|NCT01475097|"~     The purpose of this study is to evaluate and compare overall patient comfort profile between~     an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast~     media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral~     arteries.~   "
120775|NCT01475084|"~     The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid~     thoracoscopy.~   "
120776|NCT01475071|"~     The main objective of this study is to compare efficacy and safety of Metvix® natural~     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with~     Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).~   "
120777|NCT01475058|"~     This phase I/II trial studies the safety and toxicity of post-transplant treatment with~     donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in~     patients who have had a matched related allogeneic hematopoietic stem cell transplant for a~     CD19+ B cell malignancy.~   "
120778|NCT01475045|"~     The aim of the study is to compare patients' satisfaction from the use of three different~     inhalation devices by using the FSI-10 questionnaire~   "
120779|NCT01475032|"~     The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose~     inhaler (pMDI) is non-inferior to the corresponding dose of free combination of~     Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of~     BDP in terms of lung functions in asthmatic children patients.~   "
120780|NCT01475019|"~     The first aim of the investigators study, was to investigate the combined effect of~     diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH)~     levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.~      The other aim of the investigators study, was to examine the effect of hypocaloric~     diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and~     metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).~   "
120781|NCT01475006|"~     This is an open-label, sequential dose exploration study of single agent AMG 595~     administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic~     astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and~     pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in~     subjects receiving AMG 595. This study will be conducted in two parts. Part 1 will explore~     doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will~     examine the MTD established in Part 1 in subjects with recurrent GBM.~   "
120782|NCT01474993|"~     The primary objectives of this study are to answer whether there is evidence of measurable~     effects on social responsiveness (primary outcome) and other behavioral symptoms after~     treatment of autistic male adolescents and adults with orally administered sulforaphane-rich~     Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer~     whether treatment of male adolescents and adults with autism using orally administered~     sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity);~     treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and~     adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of~     principle).~   "
120785|NCT01474954|"~     This is a single-site substudy, Investigation of the Effect of Cenicriviroc (CVC) plus~     Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors, open to all patients~     enrolled in the primary study, A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of~     100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With~     Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With~     Only CCR5-Tropic Virus, in the San Francisco Bay area to evaluate changes in brachial flow~     mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at~     100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV)~     matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1~     tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS~     + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS~     + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50~     patients of the 150 total enrolled in the primary study will be referred to and enrolled in~     the cardiovascular substudy.~      Patients enrolled in the substudy and substudy protocol staff will be blinded to study~     treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory~     data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary~     study.~      The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in~     approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients~     will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000~     copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive~     all medications from the primary study, and thus the primary study site will be responsible~     for any adverse outcomes with the drug.~   "
120786|NCT01474941|"~     The primary purpose of this trial is to evaluate the safety and tolerability,~     pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a~     modified-release formulation.~   "
120787|NCT01474928|"~     In this study, the investigators aim to develop and test the effectiveness of culturally~     appropriate asthma videos and other educational materials based on knowledge from this study~     and the investigators' previous studies. By culturally appropriate materials the~     investigators mean to develop health information (in the format of video and written~     materials) in the community own language and applied the most appealing cultural beliefs and~     practices in the Chinese and Punjabi communities. The investigators also aim to recommend a~     practical framework and to develop a measure of asthma knowledge and health literacy among~     immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of~     health literacy in this study is the capability of a person to navigate and access to~     asthma-related information, as well as to understand, evaluate, and communicate the obtained~     information to improve his/her health status. The investigators' hypothesis is that~     audio-visual based asthma information in a subject's native language would improve a~     patient's knowledge and self-management of asthma in comparison to printed information.~   "
120788|NCT01474915|"~     This study is being done to determine the efficacies of two preventative drug combinations~     for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this~     study is to compare the efficacy of using aprepitant instead of ondansetron in combination~     with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By~     completing this comparison study investigators will determine the most efficacious drug~     combination which will allow us to enhance the overall comfort and satisfaction of~     neurosurgical patients in the immediate postoperative period.~   "
120789|NCT01474902|"~     The CATCH-enoxaparin trial is the natural continuation of the CATCH study. It will~     capitalize on the fact that patients enrolled in the CATCH study will be specifically~     screened for asymptomatic thromboembolism (TEs) in order to answer important clinical~     questions.~      The investigators propose a randomized controlled trial to address whether, among pediatric~     patients with congenital heart defects (CHD) recovering from cardiovascular surgery and~     diagnosed with an asymptomatic venous TE, the use of enoxaparin results in a net therapeutic~     benefit?~   "
120790|NCT01474889|"~     This study is designed to determine if real-time continuous glucose monitor (RT-CGM) can~     reverse defective Glucose counter regulation and hypoglycemia unawareness in long standing~     type 1 diabetes.~   "
120791|NCT01474876|"~     This 12-month postmarketing observational study (PMOS) was a prospective, single-arm,~     multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the~     initial baseline visit. The study was conducted to determine the long-term effectiveness of~     treatment with adalimumab in routine clinical use in participants with Ankylosing~     Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.~   "
120792|NCT01474863|"~     This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate~     biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to~     placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis~     is that intravenous L-citrulline will decreased the development or progression of acute lung~     injury in patients with severe sepsis compared to placebo.~   "
120793|NCT01474850|"~     The aim of this study is to examine chest wall volume changes monitored by opto-electronic~     plethysmography during recovery from anesthesia and early postoperative period.~   "
120794|NCT01474837|"~     Exercise as an adjunct to routine treatment may be useful for helping young people recover~     from distressing mental health problems, but they seldom get sufficient support to help them~     to exercise. The reasons for this may be that services cannot agree on the benefits of~     exercise, and the lack of reliable evidence showing the benefits of exercise in young people~     who use mental health services. Compliance with prescribed exercise is generally low, but~     the investigators think that relatively few young people will drop out of our specially~     designed programme. The investigators have found that young 'healthy' people may respond~     better if exercise is matched to their ability. The investigators are not sure if this would~     work with young people with mental health difficulties, so the investigators want to test~     it. The investigators have also found that our enabling exercise plan, with social support~     and motivational coaching, helps people with depression to take part, and not to drop out.~     The aims of our study are to see if exercise matched to their ability, with support in~     taking part, helps young people recover from distressing mental health difficulties. The~     investigators also want to ask young people how they feel about exercise as a part of their~     recovery. The investigators want to see if motivational coaching can help ongoing~     participation in exercise, and the investigators want to follow up the young people after~     six months to see if they are still doing exercise. The investigators believe that this~     study is important because it will help young people feel better about themselves, and~     improve their quality of life. This is an important national public health goal and should~     enable young people to grow into healthy adults, and maintain their health throughout~     adulthood. If our study is successful, the investigators believe that it has the potential~     to change the way in which mental health services deliver care to young people. If the~     investigators can help young people feel better about themselves, and improve their general~     health and well being through exercise, the investigators may reduce their reliance on~     mental health services.~      Research hypotheses A tailored exercise intervention will lead to significantly improved~     mental health outcomes and reduced exercise attrition rates in young people with depression.~   "
120795|NCT01474824|"~     Measurement of how much blood the heart pumps may be useful in guiding how much intravenous~     fluid to give patients during surgery. The current monitors either require special drips~     (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which~     may limit their use. Newer monitors are available which are completely non-invasive and seem~     to work well in younger patients. Patients with hip fracture are elderly and frail. The~     investigators wish to see whether the newer non-invasive monitor works well enough compared~     to the current monitors in this group of patients. If it does this may allow more of these~     patients to be monitored in this way.~   "
120797|NCT01474798|"~     This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in~     subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via~     subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total~     of 3 injections. Study drug will be administered under close observation in a facility~     equipped to handle medical emergencies. Subjects will not be discharged from the facility~     until at least 1 hour following the injection or 1 hour after their vital signs have~     stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital~     signs, clinical laboratory assessments, and the recording of adverse clinical events.~   "
120798|NCT01474785|"~     The purpose of this study is to determine if interruption in gastric-adipose tissue axis~     signaling contributes to early improvements in oxidative stress, insulin sensitivity, and~     inflammation, and to determine if interruption of the stomach in RYGB results in reduction~     of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin~     (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin~     sensitivity.~   "
120799|NCT01474772|"~     The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy~     (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates~     improvement relative to placebo on the following: reducing DPN pain, reducing pain on~     walking, and providing other benefits associated with daily activities and quality of life.~   "
120800|NCT01474759|"~     The primary aim of this research is to determine the efficacy of two portion-control~     strategies to achieve sustainable dietary and behavior changes and to promote weight loss~     and maintenance. A randomized controlled trial will test two approaches to managing portion~     sizes: one that gives individuals skills and tools to help them make appropriate portion~     choices, and another that focuses on consumption of pre-portioned foods in order to limit~     exposure to large portions in the personal food environment. A third group will receive a~     basic nutritional program to promote weight loss.~      The second aim of the research is to determine the effects of the programs on knowledge and~     consumption of appropriate portions, as assessed by innovative assessment methods and~     multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of~     individual factors that may influence the response to the portion-control interventions,~     such as psychosocial indicators, blood biomarkers, and measures of adherence to the~     interventions. The expected outcome of the project is that it will lead to the development~     of specific, evidence-based strategies to help control portion sizes in order to manage~     weight.~   "
120801|NCT01474746|"~     This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2~     years to 5 years 8 months old. The trial is six months long, and each participant will~     receive a series of tests at both the beginning and end of the study. The researchers hope~     to show improvements in language and a decrease in autistic symptoms.~   "
120802|NCT01474733|"~     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the~          effectiveness of an educational training program on the topic of health literacy for~          Family Medicine residents. The hypothesis being tested is that training residents about~          health literacy will result in improvements in residents' knowledge, skills, and~          attitudes with respect to health literacy.~        2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns~          attending mandatory trainings on the topic of health literacy throughout the three~          years of the residency program will be invited to participate in the study.~        3. Briefly describe the procedures subjects will undergo: Completion of a short~          self-administered anonymous survey before and after a variety of learning sessions on~          the topic of health literacy.~        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test~          questionnaire and 13-item post-test questionnaire designed to assess individuals'~          knowledge about health literacy, and intended clinical practices with respect to health~          literacy.~        5. If this is a clinical trial using an experimental drug and/or device, or an approved~          drug and/or device used for an unapproved purpose, briefly describe the drug and/or~          device: n/a~        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:~          Demographics and responses to individual items will be reported as frequencies and~          percentages within the sample. We will use a chi-square analysis to stratify responses~          by demographic groups and t-tests to measure possible changes over time~   "
120803|NCT01474720|"~     Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk~     for the development of shingles, a painful reactivation of the varicella zoster virus that~     causes chicken pox.~      The investigators propose to study the immune response to commercially available Zostavax~     vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and~     are on mild immunosuppressant medications, and to compare the immune response to that seen~     in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the~     study are those felt to be safe according to Centers for Disease Control guidelines.~      Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to~     receive a single, standard dose of Zostavax. Blood samples and physical examination will be~     performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants~     will receive active vaccine, there is no placebo group.~   "
120815|NCT01474564|"~     The purpose of this study is to collect blood samples and study cancer cells found in these~     blood samples from patients with pancreatic cancer. Prior research has discovered that tumor~     cells can be collected from the blood of patients with pancreatic and other cancers.~      The physicians have developed techniques for isolating and analyzing cancer cells using a~     simple blood test. They will study how these cells relate to how chemotherapy works. They~     hope to use this information to guide choices of treatment for patients in the future.~   "
120816|NCT01474551|"~     The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on~     the patient and the melanoma. Specifically, the investigators want to know how well~     vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib~     can improve how well the patient functions.~   "
120817|NCT01474538|"~     This study will provide information on the use of insulin lispro and insulin aspart in~     insulin pumps in participants with type 2 diabetes.~   "
120821|NCT01474486|"~     The purpose of this project is to conduct a preliminary test of the feasibility of a~     multi-micronutrient intervention to improve micronutrient status, cardiac function and~     quality of life in Veterans with Congestive Heart Failure (CHF).~   "
120804|NCT01474707|"~     Goal: The main goal of this study is to develop and validate educational materials that aim~     to improve self-management knowledge and practices about COPD among patients in Mandarin and~     Cantonese-speaking communities in the Greater Vancouver Area (GVA).~      Objectives: 1. To assess the current landscape of COPD beliefs, perceptions and practices,~     as well as health literacy as it relates to Chinese Mandarin and Cantonese-speaking~     patients; 2. To develop effective partnerships within primary care physicians serving~     Chinese newcomers in the GVA' 3. To conduct focus group sessions with collaborative~     primary care physicians to identify common factors that contribute to under service and~     access barriers among patients in the target communities; 4. To assess the effectiveness~     of the educational materials on patients' beliefs, perceptions, practices, and health~     literacy related to COPD control and self-management; and 5. To improve the capacity of~     physicians and allied health workers in primary care settings in educating patients and~     their families about self-management of COPD.~      The implementation of the project will include the following phases: 1. Build and~     strengthen established partnerships with primary care practices serving newcomers in GVA;~     2. Conduct an environmental scan and needs assessment (literature review, interviews and~     focus groups with community members and key-informants); 3. Development of story scripts,~     video clips and other educational materials, and relevant measurement tools; 4.~     Application of the video clips and other educational materials to test their effectiveness~     on health literacy, beliefs, and knowledge among COPD patients from the target communities;~     and 5. Evaluation of the usefulness of videos and other educational materials, and the~     project's process and outcomes.~   "
120805|NCT01474694|"~     Preoperative image-guided data correlates with the actual intraoperative reality.~     Computer-assisted preoperative planning combined with intraoperative mapping of even very~     small lesions allows for improved accuracy during complete oncological resection / ablation.~     In the short- and long-term this possibly results in better patient outcome.~   "
120806|NCT01474681|"~     This study is designed to evaluate the safety and tolerability of using HSC835 in patients~     with hematological malignancies.~   "
120807|NCT01474668|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion~     study of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at~     least a 10-hour fast from food (not including water).~   "
120808|NCT01474655|"~     The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and~     thickness of retinal layers after epiretinal membrane removal and to investigate factors~     associated with visual function.~   "
120809|NCT01474642|"~     Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response~     rates, which is most commonly used to treat patients with metastatic, recurrent or locally~     advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose~     schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day~     continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are~     inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug~     of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III~     trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in~     the first-line metastatic setting but also in the adjuvant setting. In the investigators~     experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45~     patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a~     promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with~     convenience.~      Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in~     patients with advanced esophageal cancer. A Dutch phase II study demonstrated that~     paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of~     59% with 51 patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch~     phase II study showed 43% of response rate including 4% of CR with 8 months of response~     duration when paclitaxel plus cisplatin administration was given for patients with~     metastatic esophageal cancer. Although recently first-line palliative chemotherapy regimen~     in esophageal cancer has been investigated, many trials have failed to show superiority to~     5-FU/cisplatin combination. Since the investigators considered that XP or XG (genexol) is~     more effective and convenient chemotherapy regimen than 5-FU/cisplatin, this randomized~     phase II study was planned to compare XP with XG in terms of efficacy and tolerability.~   "
120810|NCT01474629|"~     We investigate the impact of a probiotic-based dietary supplement on oxidative stress and~     endotoxemia before and after strenuous exercise.~      Hypotheses (H1):~        -  Supplementation has an influence on oxidative stress parameters before and post~          exercise~        -  Supplementation has an influence on parameters of endotoxemia and inflammation before~          and post exercise~        -  Strenuous exercise has an influence on parameters of oxidative stress, inflammation and~          endotoxemia~   "
120811|NCT01474616|"~     Almost 90 percent of residents living in long-term care facilities have some type of~     mobility limitation, which worsens quickly once they move into a long-term care facility.~     This means that they cannot easily walk or move around in their day-to-day lives and this~     can have serious consequences for their general health and well-being. Researchers have~     shown that exercise can help the mobility of even the oldest of adults but elderly residents~     in long-term care facilities still commonly sit or lie in bed for long periods of time, in~     many cases for most of their waking hours. The purpose of this research is to study the~     effect of a simple physical activity on the mobility and quality of life of residents in~     long-term care facilities. Researchers will introduce a sit-to-stand activity to health care~     aides which will become part of their daily routine with residents. The basic sit-to-stand~     movement is already a part of the daily activities that health care aides do with residents.~     Specifically, health care aides will ask residents to repeat the sit-to-stand activity at~     mealtimes, when using the toilet, and on other occasions of daily activity. An important~     part of this research is to find out how well the activity preserves the ability of~     residents to stay mobile and also to examine how this will improve their quality of life in~     the home. The MOVE study will demonstrate whether it is possible to delay the loss of~     mobility in long-term care residents by incorporating the sit-to-stand activity into the~     regular practice of health care aides.~   "
120812|NCT01474603|"~     Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes~     are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a~     previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish~     adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational~     study the investigators will apply n-3 polyunsaturated fatty acids as addition to a~     protein-enriched diet with low glycemic index to overweight and obese patients with insulin~     resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy~     parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and~     all other patients, respectively.~   "
120813|NCT01474590|"~     Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group~     comparison study in subjects with severe acne vulgaris on the face.~   "
120822|NCT01474473|"~     CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.~     Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells,~     known as extracellular matrix, by binding to structural proteins, and 2) in the cell~     communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are~     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By~     replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores~     the matrix architecture and the cell communication, a process known as Matrix Therapy.~      As for now, three non-controlled pilot studies have been carried out on small populations.~     They have shown a substantial enhancement of chronic wounds state after treatment with~     CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether~     CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is~     mandatory.~      The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar~     ulcer in an off-loading mandatory context would reinitiate the natural process of tissue~     regeneration and lead to total wound closure faster than following standard wound care.~   "
120823|NCT01474460|"~     Background: Warfarin is used as an anti-coagulant in patients at risk of developing~     thrombosis. It has a narrow therapeutic index necessitating close monitoring of~     International Normalized Ratio (INR). According to a meta-analysis, patients were in~     therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis.~     Various retrospective and prospective studies have looked at supplementation with~     phytonadione in these patients to reduce the variability of INR showing an improvement in~     variability. Most of these studies have only been done in a small number of patients already~     on warfarin therapy. This study will focus on patients newly starting warfarin therapy.~      Methods: This study is a prospective, randomized, controlled trial performed at James A.~     Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will~     receive either phytonadione with warfarin or warfarin alone. Based on a power calculation~     for 80%, a total of 370 patients will be enrolled (185 participants in each arm).~     Participants will be randomized to either intervention or control. Intervention group~     participants will be prescribed their usual starting dose of warfarin along with 200 mcg~     phytonadione by mouth daily. Control group participants will be prescribed their usual~     starting dose of warfarin. Both groups will follow the usual standard of care. They will~     come in for a follow-up INR and warfarin dose titration at least once per week until~     therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will~     participate in anticoagulation clinic activities that constitute the current standard of~     care. Intervention will last for a total of 6 months for each participant once enrolled.~      Hypothesis:Participants in the intervention group being supplemented with 200mcg of~     phytonadione will spend more total time with a therapeutic INR than participants in the~     control group.~   "
120824|NCT01474447|"~     The purpose of the research is to check the efficiency of practicing the tools of the~     Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a~     result of the pain, and improving the general quality of life.~      The hypothesis suggests that by learning to perceive pain differently, the level of pain~     will reduce and general well-being improved.~   "
120825|NCT01474434|"~     This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact~     cardiovascular risk.~   "
120826|NCT01474421|"~     This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate~     to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's~     disease.~   "
120827|NCT01474408|"~     The primary aim is to determine the acute effect of two different training interventions on~     venous plasticity in patients with myocardial infarction (MI), revascularization or coronary~     artery graft surgery compared to age-matched healthy subjects.~   "
120828|NCT01474395|"~     Persistent neurocognitive deficits are a major cause of severe disability and impaired~     long-term psychosocial outcome in schizophrenia (SZ). In particular, within the auditory~     system, early deficits such as the behavioral and neurophysiological ability to match tones~     that vary in pitch correlate with impairments in auditory emotion recognition (affective~     prosody) and general functioning, suggesting that interventions aimed at remediating~     sensory-level dysfunction may lead to significant improvement in higher order~     cognitive/emotion processes. Efforts to ameliorate cognitive deficits in schizophrenia~     utilize either pharmacological agents or behavioral treatments such as cognitive~     remediation, which generally focus on higher order processes, and not on the early sensory~     processing which may be key to functioning.~      Numerous pharmacological agents have been proposed, but accumulating evidence suggests that~     dysfunction of the N-methyl-D-aspartic acid (NMDA) receptor may be one of the root causes of~     schizophrenia, including sensory and cognitive impairments, suggesting that an NMDA based~     treatment may be efficacious in reversing these deficits. D-Cycloserine, a synthetic partial~     NMDA agonist has been used in anxiety disorders to augment learning in cognitive~     remediation. Because of a tendency to act as an NMDA antagonist at higher doses~     D-cycloserine is not effective in schizophrenia. In contrast, D-serine (DSR), is a full~     agonist, and is therefore more ideal for enhancing NMDA function and cognitive remediation.~     While previous use of DSR was limited by safety concerns in rodents,the investigators have~     shown that it can safely be used at doses of 60 mg/kg and, moreover, demonstrates converging~     improvement in symptomatic, cognitive and sensory-based measures in schizophrenia. Evidence~     also suggests that NMDA receptor dysfunction in schizophrenia may be relative, rather than~     absolute, suggesting that the enhanced practice of a cognitive remediation paradigm might be~     able to overcome reduced plasticity and treat cognitive dysfunction.~      This project will be the first to combine the NMDA based and sensory-based cognitive~     remediation (SBR) approaches, and will utilize not only DSR, but also a tone matching SBR~     paradigm has been shown to enhance learning in healthy controls, as well as a paradigm~     designed to augment visual motion detection. This study will pilot these interventions in a~     double-blind, placebo-controlled, randomized crossover design that will use neurophysiology~     together with cognitive tests to explore the effects on brain activity and cognitive~     function in 16 patients with schizophrenia or schizoaffective disorder. The investigators~     hypothesize that DSR+SBR will lead to improvement. Subjects will have an initial visit to~     establish baseline performance on cognitive tasks before returning for 3 visits when they~     will receive blinded study medication [60 mg/kg of DSR (2 days) or placebo (1 day)] in a~     randomized order. The procedures on the treatment days will include the SBR paradigm and~     pre/post neurophysiological measurements. Primary outcomes are improvements in~     neurophysiologic and behavioral sensory processing. The main goal is to establish the~     preliminary efficacy to use in a follow-up multi-dose study utilizing a multiple session SBR~     R01 application.~   "
120829|NCT01474382|"~     The purpose of this study is to determine whether OraVerse is safe and effective for the~     reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.~   "
120830|NCT01474369|"~     The purpose of this study is to investigate the superiority of efficacy of TAK-438, once~     daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.~   "
120831|NCT01474356|"~     The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with~     interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free~     survival (DFS), or acute and late side effects in patients with advanced cervical cancer.~     Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG~     score. Following the completion of radiochemotherapy, consecutive patients with cervical~     cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT~     alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were~     included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was~     administered for 45 minutes before and during the HDR BT. Follow-up examinations were~     scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years,~     and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were~     obtained from these patients.~   "
120832|NCT01474343|"~     The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical~     study evaluating the tolerance and the safety of intracerebral administration of~     adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the~     treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of~     the investigational medicinal product SAF-301 to both sides of the brain through 6~     image-guided tracks, with 2 deposits per track, in a single neurosurgical session.~      The primary objective is to assess the tolerance and the safety associated to the proposed~     treatment through a one-year follow up.~      The secondary objective is to collect data to define exploratory tests that could become~     evaluation criteria for further clinical phase III efficacy studies.~      Four patients will be included in the clinical trial and will be followed during one year.~      The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The~     Neurosurgery will be performed at Necker-Enfants Malades Hospital.~      Safety will be evaluating on clinical, radiological and biological parameters.~   "
120833|NCT01474330|"~     To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered~     orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.~   "
120834|NCT01474317|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
120835|NCT01474304|"~     Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease~     opioid requirements over the first 12 hours of postoperative recovery following craniotomy.~     Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use~     hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.~   "
120836|NCT01474291|"~     This prospective, multi-center, observational study will evaluate factors influencing the~     use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in~     real life setting. Data will be collected from participants for 12 months following~     initiation of tocilizumab treatment.~   "
120837|NCT01474278|"~     This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and~     the safety and tolerability of a single dose of RO5028442 in adult male high-functioning~     autistic patients. In a cross-over design, patients will be randomized to receive either a~     single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated~     time on study is up to approximately 9 weeks.~   "
120838|NCT01474265|"~     This study has the following primary aim:~      - the main objective of this study is to investigate the effects of smoking cessation during~     quit attempts on sympathovagal balance. These effects will be observed in smokers quitting~     smoking with pharmacological support or without.~      Secondary aims of this study are also:~        -  the definition of MSNA in smokers and non-smokers~        -  the investigation of other parameters concerning the autonomic nervous system, like~          baroreflex-sensitivity, heart rate-variability before and during the quit attempt.~        -  the definition of withdrawal symptoms and craving before, during and after the quit~          attempt.~        -  the investigation of effects of smoking cues on craving and sympathovagal balance~        -  the investigation of relapse rates after smoking cessation in correlation with the~          parameters mentioned above.~   "
120839|NCT01474252|"~     The purpose of this study is to evaluate intubation duration between rapid sequence~     intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed~     by emergency medicine residents in Siriraj hospital.~   "
120840|NCT01474239|"~     This randomized, non-comparative study will evaluate the efficacy and safety of Avastin~     (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to~     receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8~     and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks.~     Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison~     will be made between the two treatment arms. The anticipated time of study treatment is~     until disease progression or unacceptable toxicity.~   "
120841|NCT01474226|"~     The purpose of this study is to investigate the digestibility of the amino acid lysine in~     cooked rice in adult men using stable isotope technique.~   "
120842|NCT01474213|"~     The purpose of this study is to compare the sedation effect of dexmedetomidine and target~     controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing~     oral maxillofacial surgery.~   "
120843|NCT01474200|"~     The purpose of the research is to determine if patients have fewer Heart Failure (HF) events~     after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90~     days of discharge from the hospital. Heart Failure events are defined as returning to the~     hospital, clinic or emergency department (ED) for treatment of HF symptoms.~   "
120844|NCT01474187|"~     Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy~     (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some~     current studies showed that irinotecan's dose can be increased significantly for those~     patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this~     trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.~   "
120845|NCT01474174|"~     This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients~     with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective~     immune response and help prevent flu in patients who are receiving chemotherapy for CNS~     tumors~   "
120846|NCT01474161|"~     The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to~     compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60~     mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male~     subjects and to assess the impact of gender on this relative bioavailability after~     administration in male and female subjects.~      Using the new formulation, a single and a multiple ascending dose study will be performed in~     overweight or obese male subjects otherwise healthy whose demographic and physiological~     characteristics are thought to be closer to those of the target population (Type 2~     diabetes). Thereafter, a group of male and female patients with Type 2 diabetes will receive~     multiple dose administration of GFT505.~   "
120847|NCT01474148|"~     The purpose of this study is to evaluate a surgically implanted functional electrical~     stimulation (FES) system to facilitate stability of the trunk and hips. FES involves~     applying small electric currents to the nerves, which cause the muscles to contract. This~     study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal~     cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.~   "
120848|NCT01474135|"~     This is a double-masked, randomized, controlled study assessing the safety and ocular~     hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to~     Travatan® Z in patients with elevated intraocular pressure~   "
120849|NCT01474122|"~     The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial~     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing~     Period 1 continue on their original randomized treatment into Period 2, until the last~     randomized patient has completed Period 1.~      Patients are randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).~      The primary objective is to demonstrate the effect of macitentan on the reduction of the~     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers~     (DU).~      Other objectives include:~        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at~          Week 16 in SSc patients with ongoing DU disease.~        -  the evaluation of the safety and tolerability of macitentan in these patients.~        -  the evaluation of the efficacy of macitentan on time to first DU complication during~          the entire treatment period.~   "
120877|NCT01473758|"~     The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic~     inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In~     addition, the potential benefit of roflumilast on severity and recovery periods of acute~     COPD exacerbations will be assessed using patient diaries and questionnaires.~   "
120850|NCT01474109|"~     The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial~     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing~     Period 1 will continue on their original randomized treatment into Period 2, until the last~     randomized patient has completed Period 1.~      Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).~      The primary objective is to demonstrate the effect of macitentan on the reduction of the~     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers.~      Other objectives include:~        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at~          Week 16 in SSc patients with ongoing DU disease.~        -  the evaluation of the safety and tolerability of macitentan in these patients.~        -  the evaluation of the efficacy of macitentan on time to first DU complication during~          the entire treatment period.~   "
120851|NCT01474096|"~     The purpose of this study is to determine whether an implementation strategy for a~     breastfeeding guide is more effective than the usual practice (simple circulation of the~     guide) in terms of increasing the percentage of children receiving exclusive or preferential~     breastfeeding at 6 months age.~   "
120852|NCT01474083|"~     The purpose of this trial is to study the drug levels and biomarkers in the body and the~     safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in~     the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of~     the 4 treatments will be placebo, which does not contain an active ingredient. The study~     participation includes in-patient and out-patient days.~   "
120853|NCT01474070|"~     IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation~     tonometry (GAT)).~   "
120854|NCT01474057|"~     This study will compare a cognitive-behavioral online self-management intervention designed~     for primary care treatment of war-related PTSD to a control intervention, optimized usual~     primary care PTSD treatment. Patients with PTSD will be trained to use the online PTSD~     treatment website and asked to do so three times per week for six weeks. They will have~     phone and email access to a nurse trained to assist them in their treatment program. Three~     scheduled phone check-ins during the six week treatment period will provide ongoing contact~     with patients during treatment. The investigators will assess PTSD symptoms, depression,~     anxiety and somatic symptoms, physical health status and occupational functioning on three~     occasions: before the intervention, at the end of the treatment period, and six weeks after~     the end of treatment.~   "
120855|NCT01474044|"~     The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe~     and effective in the treatment of chronic atrophic gastritis (CAG).~   "
120856|NCT01474031|"~     Research protocol prospective study Deltamotion - DAA THA study~        1. Introduction Very few gait analytical data are available concerning the Direct Anterior~          Approach (DAA) in total hip arthroplasty (THA). All the studies have focused on~          immediate post-operative recovery. These studies have in general some important~          shortcomings in order to accurately evaluate the biomechanics of the replaced hip~          joint. None of the published reports have reported on consecutive intervals of pre-op -~          6w - 3m - 6m - 12m. This is of interest as we know that recovery with other approaches~          takes >1 year. It might be that the DAA approach leads to normal gait patterns at 3m or~          6m and that these patterns do not differ from the normal pattern or at >1y post-op.~          None of the reports utilized out-of-plane movements such as coming down or up stairs or~          squads. Muscle strength of the abductors has not been tested. Utilizing trunk markers~          is frequently not done but it is important to evaluate the centre of mass position~          during gait. Very few studies utilize kinetic data, which are important in order to~          thoroughly evaluate the biomechanics and loading of the hip. And maybe most~          importantly, the biomechanical effect of the diameter of the articulating surface on~          gait parameters following the DAA has never been evaluated.~           One of the most important advantages of the DAA is the muscle sparing aspect and the~          presumption that the femoral anatomy and biomechanics can be more accurately and~          precisely restored. If the diameter of the articulating surface has then also been~          reconstructed to the almost anatomical diameter, we can assume that this should be the~          most optimal reconstruction of the hip joint currently available. This could lead to~          early return to normal gait, to optimal joint loading and a minimal amount of stress~          shielding of the femoral bone.~           The aim of this project is (1) to prospectively analyse the biomechanics of the hip~          joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior~          Approach and (2) to assess the femoral bone remodelling around the fully coated Corail~          stem over the first year post-operatively.~        2. Materials and Methods Hypothesis: (1) The temporo-spatial parameters (velocity,~          cadence, step length, and stride length) and gait kinematic and kinetic data (external~          hip and knee muscle moments) are not significantly different between the study and~          control group at the evaluated time intervals indicating normal or near normal gait~          patterns in the early post-operative recovery phase. (2) Stress shielding of the bone~          around the femoral stem as measured with the DEXA scan can be predicted accurately with~          the FE analysis based on the collected data indicating the validity of the~          musculoskeletal models.~      Estimated inclusion time: 1 July 2011 - 31 December 2011 Cohorts: 20 DAA subjects - 20~     control subjects~      Assessments:~        -  Time interval: pre-op - 3m - 6m - 12m~        -  Assessment of all subjects:~             -  XR with magnification marker~             -  Biodex force measurement in flexion and extension and mid flexion (with EMG if~               possible)~        -  Gait analysis with surface EMG and trunk markers:~             -  Unipodal standing: 3 trials Right and 3 trials Left on FP~             -  Level walking: 3 trials Right and 3 trials Left on FP~             -  Chair rise: 3 trials, both legs on FP~             -  Stair ascent: 3 trials Right and 3 trials Left on first FP~             -  Stair descent: 3 trials Right and 3 trials Left on first FP~             -  Squat: 3 trials, both legs on FP~             -  Bipodal squat: 3 trials Right and 3 trials Left on FP~        -  Functional scores (HHS, UCLA, HOOS, SF-36)~        -  DEXA scan pre-op and at 12 months~        -  Assessment of final 5 subjects per group:~             -  CT pre and post at 6w (pre: pelvis-knee and post: hip)~             -  MRI pre and 1 y post~             -  Accelerometer 1 week~   "
120857|NCT01474018|"~     QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2~     diabetes will result in improved glycemic control, reduced exogenous insulin requirement,~     increased lean fat mass and improved pancreatic beta-cell function.~   "
120858|NCT01474005|"~     This study aims to evaluate the effectiveness of an artificial larynx on the restoration of~     laryngeal functions, mainly breathing and swallowing.~   "
120859|NCT01473992|"~     The purpose of this study is to determine if transfemoral amputees of varied etiology will~     demonstrate increased function, safety and quality of life following accommodation with a~     new knee prosthesis as compared to their former C-Leg knee prosthesis.~   "
120860|NCT01473979|"~     Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating~     complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from~     1% to 3% with a high mortality rate from 19% to 29% .~      The most devastating complication of the open sternum is the laceration of the right~     ventricle which has a very high mortality. Additionally destabilizations of the thoracic~     cage, prolonged immobilization, or substantial surgical trauma are further complications of~     the conventional strategy (4). In addition, postoperative infections after sternotomy are~     associated with prolonged hospital stay, increased healthcare costs and impaired quality of~     patient life, representing an economic and social burden. The emergence of increasing~     antimicrobial resistant bacteria augments the importance of postsurgical infections since~     the antimicrobial choices are becoming limited. Furthermore, the incidence of infection is~     an indicator for the quality of patient care in the international benchmark studies.~      Although several therapy strategies are nowadays present in clinical practice, there is a~     lack of evidence based surgical consensus for treatment of this surgical complication. In~     most case the poststernotomy mediastinitis is involving surgical revision with debridement,~     open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest~     wound was achieved secondary closure and/or reconstruction with vascularized soft tissue~     flaps such as omentum or pectoral muscle is performed.~      It seems there is a need for more effective surgical treatment of poststernotomy wound~     infections, which may address the prolonged hospitalization and reduce number of surgical~     interventions and with this also perioperative morbidity. In light of this we propose a~     randomized study comparing new delay primary closure of the sternum to the secondary vacuum~     assisted closure.~   "
120861|NCT01473966|"~     Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit~     (ICU) patients.~   "
120862|NCT01473953|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the safety, tolerability and pharmacokinetics (exposure in the body) of~     liraglutide-depot in healthy subjects.~   "
120863|NCT01473940|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent~     pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as~     ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or tumor-killing substances~     to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different~     ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy~     together with chemotherapy may kill more tumor cells.~   "
120876|NCT01473771|"~     The purpose of this multi-site randomized controlled trial is to determine if the Caring~     Letters intervention is effective in preventing suicide and suicidal behaviors among U.S.~     Service Members and Veterans. The primary aim of this project is determine whether caring~     communications following inpatient psychiatric treatment reduce suicide and self-inflicted~     injuries among U.S. military personnel and Veterans. The investigators will also explore~     treatment utilization by comparing the frequency of treatment visits after enrollment into~     the study. The following specific hypotheses will be tested:~      Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency~     of suicide will be lower among participants in the Caring Letters group compared to those in~     the Usual Care group.~      Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower~     in the Caring Letters group compared to the Usual Care group.~      Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be~     longer among participants in the Caring Letters group compared to the Usual Care group.~   "
120864|NCT01473927|"~     Background Determining disease activity in IBD is sometimes difficult and, to be accurate,~     requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker~     for IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be~     more reliable and has shown a certain value as predictive marker. Our preliminary data now~     show, that the serum concentrations of ficolin-2 are significantly higher in CD patients~     with a HBI >3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like~     MBL, can activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was~     not detected in our patient cohort, nor could we find functional deficiencies for ficolin-2~     (paper submitted).~      Study Aims The study is aimed to substantiate the data from our pilot study which shows that~     ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the~     study will measure ficolin-2 concentrations in a sufficiently large patient group to obtain~     enough statistical power and to compare these results with the endoscopic disease score~     (SES-CD) and CRP and calprotectin values. Statistical analysis of the data will show us if~     ficolin-2 is a reliable and easy to obtain new marker for active inflammation in CD.~      Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be~     analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine~     endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be~     collected at the day of endoscopy. Stool sample will be collected within the same week of~     endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics,~     ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data~     will be statistically analyzed.~   "
120865|NCT01473914|"~     A pilot randomized trial that compares a new renal nutritional supplement with the standard~     renal vitamin.~      The primary objective is to compare two doses (medium and high) of the new supplement with~     the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD).~      Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger~     trial.~   "
120866|NCT01473901|"~     This clinical study will assess the doses of BKM120 appropriate for patients with newly~     diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.~   "
120867|NCT01473888|"~     Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study~     will help determine which types of drugs may interact with T89.~   "
120868|NCT01473875|"~     This phase 2/3, open-label extension study will evaluate the long-term efficacy and safety~     of intravenous (IV) infusions of SBC-102 in children with Lysosomal Acid Lipase (LAL)~     Deficiency who previously received treatment with SBC-102.~   "
120869|NCT01473862|"~     Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are~     typical responses. How teens with cancer cope with the loss of a loved one or a close friend~     has not been well-studied in the bereavement or oncology literature. This study will~     describe the impact of loss on teen patients who are on treatment or have recently completed~     treatment for malignancy. We will look at baseline personality traits and ask teens to~     identify losses in their life. We will ask questions about coping and meaning-making after~     loss. A parent will be invited to participate -to measure parental awareness of teen loss~     and determine if parental coping affects teen coping. The inventories have been validated by~     other researchers.~   "
120870|NCT01473849|"~     The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver~     transplant recipients remains controversial. Although some studies (Teixeira et al., 2000;~     Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV~     infection, studies such as Rosen et al. show that 50% of patients with CMV infection~     suffered cirrhosis durig follow-up period, while between not-infected patients the rate was~     11%. To clarify this question, a non-interventional study will be carried out in order to~     assess if CMV replication is a risk factor for graft dysfunction in liver transplant~     recipients.~   "
120871|NCT01473836|"~     The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult~     subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000~     mg/day in combination with ceftriaxone sodium.~   "
120872|NCT01473823|"~     Although some causal factors in allergy development such as allergen exposure and~     environmental pollution have decreased during recent years, the incidence of the allergic~     diseases has increased in the Western world. Since the genetic predisposition to develop~     allergies cannot change in such a short time it is conceivable that, instead of the emerging~     of some new and unknown risk factors, some protective factors seem to have disappeared in~     the Western world.~      Allergic disease is a tendency to develop allergies to allergens in the surrounding~     environment. The most common symptoms are eczema and food allergy in the early life,~     bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during~     school age and adolescence, the so-called allergic march. Some person may develop only one,~     but others some or all of the symptoms. Inheritance, environment and allergen exposure are~     important factors affecting this march but there are important factors that predict later~     development of diseases. Sensitization to egg (positive skin prick test or specific IgE to~     egg in the serum) combined with skin problems in infancy predispose strongly to the~     development of allergic asthma in later life.~      The purpose of this work is to supply children with early development of IgE associated~     eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the~     effect of the supplementation on the future development of skin symptoms, food allergy,~     sensitisation against inhalant allergens and asthma in these children. We will also assess~     immunological markers of Th2-skewed immunity in relation to clinical effect of the~     supplementation.~      Families with children younger than 12 months referred to the paediatric department at~     Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East~     of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens~     (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical~     examination by a paediatrician and assessment of disease severity with SCORAD will be~     performed by a research nurse at inclusion. The children will be assessed every six months~     by a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical~     assessment will be performed yearly until age 7.~   "
120873|NCT01473810|"~     HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic~     immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the~     absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to~     decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods,~     and better select candidates for preventive HIV vaccines.~      Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four,~     slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal~     injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found~     improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at~     the AIDS vaccine 2011 conference, Bangkok).~      In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the~     nasal mucosal surfaces in conjunction with Endocine, a newly developed and documented~     mucosal adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both~     systemically and at mucosal surfaces (oral, rectal, vaginal).~   "
120874|NCT01473797|"~     ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5~     days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary~     Langerhans cell histiocytosis and impairment of lung function patients.~   "
120875|NCT01473784|"~     This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with~     benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for~     head and neck cancer and may have fewer side effects and improve recovery~   "
120878|NCT01473745|"~     study hypothesis~        1. The aim of this study:~           How can the investigators predict and control the nasal changes after maxillary LeFort~          I osteotomy with 2 different alar base suture techniques ?~        2. Study hypothesis~             -  Null hypothesis: Nasal changes were not affected by 2 different alar base suture~               techniques after maxillary LeFort I osteotomy~             -  Alternative : Nasal changes were affected by 2 different alar base suture~               techniques after maxillary LeFort I osteotomy~   "
120879|NCT01473732|"~     The purpose of this study is to find out how well the current drug regimen (including low~     Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration~     in the kidney function) works and how safe it is when compared to a combination of Zortress~     and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.~   "
120880|NCT01473719|"~     The purpose of this study is to if a brief motivational intervention, compared to health~     education sessions, reduces alcohol and marijuana use and is related to fewer sexually~     transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana~     use.~   "
120881|NCT01473706|"~     The purpose of this study is to compare the accuracy of a new consumer nutrition screening~     tool to an established and validated nutrition screening tool currently completed by~     healthcare practitioners.~   "
120882|NCT01473693|"~     The purpose of this study is to learn about the effects of cancer treatment on the brain.~     Some cancer patients report changes in their memory or thinking after treatment. These~     changes could be a result of changes in brain structure, such as a change in size or~     thickness of different parts of the brain. The investigators will look to see if these~     changes in brain structure happen through the results of magnetic resonance imaging (MRI).~     The investigators will do this by looking at the brain structure of lung cancer patients who~     have surgery and chemotherapy versus those who have surgery only.~   "
120883|NCT01473680|"~     This study is being done to find out if it is possible to enroll minority women with breast~     cancer in a study of how chemotherapy may affect their ability to answer certain questions~     and perform certain tasks that measure brain activity. The investigators want to look at~     thinking and brain activity in patients to see if cancer treatments can cause any brain~     changes. For this study, women without cancer, are being asked to participate in order to~     compare the answers to the questions and the brain wave activity measured in the women with~     cancer to women who don't have cancer.~   "
120884|NCT01473667|"~     The purpose of this study is to investigate clinical outcomes from two current standard of~     care pain control procedures performed for patients undergoing pacemaker insertion.~   "
120885|NCT01473654|"~     The goal of this randomized control trial is to study the impact of an electronic health~     record embedded tool's ability to facilitate shared provider-patient goal setting to promote~     lifestyle behavior change and prevent diabetes in primary care.~   "
120886|NCT01473641|"~     This study characterises the frequency of specific insertion-, localization- and~     removal-related events and clinically significant consequences thereof among Nexplanon users~     in the US during routine clinical use.~   "
120887|NCT01473628|"~     The goal of this clinical research study is to learn if adding rituximab to radiation~     therapy will help control the disease better than radiation alone. The safety of this~     combination will also be studied.~      Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.~      Rituximab is designed to attach to cancer cells that have CD20 (a tumor marker) on their~     surface and damage them, which may cause the cells to die.~   "
120888|NCT01473615|"~     The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based~     Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with~     chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a~     psychological and neurobiological level. For this purpose the study subjects will fill out~     several psychological questionnaires related to mindfulness, depression and chronic pain.~     Moreover this study involves optional fMRI scans of the brain and blood measures before and~     after the intervention.~      Main hypotheses:~        1. The MBCT training will be a feasible intervention in patients with chronic pain and~          co-morbid depression as defined by no occurrence of serious adverse events related to~          the intervention and a retention rate of more than 70% in the subjects assigned to the~          MBCT arm.~        2. Patients who have completed the MBCT training will demonstrate a significant decrease~          in depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology~          - Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17)~          (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure),~          compared to the control group.~   "
120889|NCT01473602|"~     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,~     will improve the healing of hip (femoral neck) fractures that are repaired during surgery~     using certain types of orthopedic screws. The study will enroll men and postmenopausal women~     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for~     example, fall from standing height or less).~   "
120890|NCT01473589|"~     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,~     will improve the healing of hip (femoral neck) fractures that are repaired during surgery~     using certain types of orthopedic screws. The study will enroll men and postmenopausal women~     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for~     example, fall from standing height or less).~   "
120891|NCT01473576|"~     A diet rich in leafy green vegetables has been shown to reduce the risk of developing~     chronic metabolic disease. The health benefits from these particular vegetables may be~     attributed to their high nitrate content. Recent work suggests that dietary nitrate triggers~     endogenous nitric oxide release, thereby stimulating vasodilation and improving muscle~     perfusion in an insulin-independent manner. We hypothesize that in an insulin-resistant~     state, nitrate co-ingestion will increase muscle perfusion, thereby improving post-prandial~     delivery of nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of~     food derived amino acids will stimulate post-prandial muscle protein synthesis and, as such,~     compensate for a blunted muscle protein synthetic response to food intake in the elderly.~     This proposal will investigate the efficacy of nitrate co-ingestion as a means to augment~     muscle protein synthesis in elderly, type 2 diabetes patients and may lead to a novel~     therapy in the clinical care of type 2 diabetes patients.~   "
120892|NCT01473563|"~     The main purpose for this study is to answer the following research questions:~        -  Can pemetrexed be administered safely at the participant's home, using the same~          treatment procedure as in a hospital setting?~        -  Will the participant be satisfied with home care?~        -  How might this impact the participant's quality of life?~        -  What are the required medical resources needed to give pemetrexed in a home setting?~   "
120893|NCT01473550|"~     Patients with mood disorder or psychotic disorder will be given handheld devices with~     personal health records to educate, monitor and deliver customizable healthcare tools based~     on their personal needs. The use of technology has great potential to deliver care more~     effectively and efficiently. No actual information is on the handheld device - it is~     accessed from a secure site behind hospital firewalls.~   "
120894|NCT01473537|"~     Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design:~     Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution~     (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.~      Procedure: Rinses are performed in the evening. The rinse combinations are given in a random~     order, and the subjects are unaware of the sequence. At least 3 days separates the use of~     each rinse. Dosage: 20 mL and 1 minute rinse with each solution.~      Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by~     expectoration.~      Analysis: The fluoride concentration in saliva samples are analysed Statistics and data~     handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated~     measures design.~   "
120895|NCT01473524|"~     The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist.~     FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body~     to help with digestion. It is hypothesized that regular treatment with OCA will improve~     liver function in persons with Primary Biliary Cirrhosis (PBC).~   "
120896|NCT01473511|"~     Strongest Families (formerly Family Help)is an evidence-based, distance health education~     model for families who have children with behavioural difficulties. The principal research~     question is Does Strongest Families, a 12-week, home-based program of interactive readings,~     instructional videos, homework projects, and weekly coaching telephone calls out perform~     the care families typically experience when referred to a mental health service?. The~     investigators hypothesize that children randomized to Strongest Families intervention will~     show a significantly greater reduction in externalizing behaviour problems than those~     randomized to a Control (usual care). In addition, parents randomized to Family Help will~     report a greater improvement in parenting skills and a greater reduction in symptoms of~     emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the~     Control condition. Finally, families randomized to Family Help will use fewer mental health~     services than Controls.~   "
120897|NCT01473498|"~     Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury~     (AKI) is commonly encountered in critically ill patients and independently predicts poor~     outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI.~     To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated~     by renal Doppler could lead to a better renal perfusion, and then less AKI.~   "
120898|NCT01473485|"~     A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound~     Surgery in the Treatment of Brain Tumors~   "
120899|NCT01473472|"~     This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel~     groups is designed to evaluate a strategy for the prevention of HIV infection including on~     demand antiretroviral pre-exposure with Truvada versus placebo, associated with overall~     prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B~     virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV~     infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed~     recent studies have reported a higher incidence of new HIV infection in MSM as compared to~     the general population, new approaches to the prevention of HIV infection are, therefore,~     necessary in order to consider the limits of current strategies.~   "
120900|NCT01473459|"~     The purpose of this study is to compare two fertility protocols in obese women with~     Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These~     protocols carry less risk of ovarian hyperstimulation syndrome which these women may~     experience.~   "
120901|NCT01473446|"~     Is goal directed fluid therapy reducing postoperative complications in comparison to~     traditional fluid therapy for gastro surgical ASA III/IV patients?~      The investigators compare two groups of patients: one group receives goal directed fluid~     therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the traditional~     fluids, ie the current regime.~   "
120902|NCT01473433|"~     The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose~     pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a~     chronic myocardial infarct. Preclinical studies in the porcine model of myocardial~     infarction have shown that AdiFLAP reduces infarct area.~   "
120903|NCT01473420|"~     The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)~     Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb)~     levels and study drug dose requirements in patients treated for anemia associated with~     chronic renal failure and on hemodialysis.~   "
120904|NCT01473407|"~     The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira~     compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose~     requirements in patients treated for anemia associated with chronic renal failure and on~     hemodialysis.~   "
120905|NCT01473394|"~     The purpose of this study was to further characterize the efficacy, safety, and tolerability~     of a single fixed dose level of vilazodone compared to placebo in patients with major~     depressive disorder.~   "
120906|NCT01473381|"~     The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed~     dose levels of vilazodone compared to placebo in patients with major depressive disorder.~   "
120907|NCT01473368|"~     The purpose of this study is to compare and contrast the effects of the probiotic~     Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the~     gut microbiota of healthy volunteers.~   "
121332|NCT01467752|"~     Traumatic cartilage loss of the joint is central to the development of joint failure in~     arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal~     joint defects.~   "
120908|NCT01473355|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm~     diameter implant in a Chinese population by evaluation of marginal bone level alteration,~     implant stability and implant survival in the posterior mandible up to 3 years after~     loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.~   "
120909|NCT01473342|"~     This study is focused on the development and pilot/feasibility testing of a smartphone~     application to promote a healthy diet, increase physical activity, and prevent weight gain~     in adolescent survivors of childhood cancer.~   "
120910|NCT01473329|"~     Education is the mainstay of treatment of diabetes mellitus (DM), since it is through her~     that patients are trained to perform the management of your disease. There is a wide range~     of educational interventions tested in patients with DM, not having been defined so far a~     universal template that can be standardized and recognized as effective for all individuals~     with the disease. The present study aims to evaluate the effect of a group based structured~     education program, applied by a primary care generalist nurse, on metabolic control of type~     2 diabetes mellitus (DM2) patients attending a primary care unit.~   "
120911|NCT01473316|"~     This will be an open-label, fixed-sequence, single-center, 2 period study. The study is~     designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.~   "
120912|NCT01473303|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan~     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such~     as ganitumab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. It is not yet known whether giving more than one drug (combination~     chemotherapy) is more effective with or without ganitumab in treating patients with~     pancreatic cancer.~      PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and~     ganitumab and how well combination chemotherapy with or without ganitumab works in treating~     patients with previously untreated metastatic pancreatic cancer.~   "
120913|NCT01473290|"~     RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in~     patients undergoing chemotherapy and pelvic radiation therapy.~      PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in~     preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic~     radiation therapy.~   "
120914|NCT01473277|"~     The aim of this study is to confirm the efficacy and safety of the intra-articular injection~     of BT-A in a multicentric double blind randomised study. For this purpose intra-articular~     injection of BT-A will be compared with the intra-articular steroid injection that is the~     current gold standard for the treatment of HSP.~   "
120915|NCT01473264|"~     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result~     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical~     ventilation and infection. These conditions initiate an inflammatory response characterized~     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the~     development of significant acute and chronic lung injury.~      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10~     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and~     is the most abundant protein in the mucosal fluids in normal healthy lungs.~      The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and~     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated~     premature infants receiving positive pressure ventilation for treatment of respiratory~     distress syndrome (RDS) to prevent long term respiratory complications referred to as~     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;~     asthma, cough, wheezing, multiple respiratory infections).~      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary~     tissue while preserving pulmonary mechanical function during various insults (eg. viral~     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties~     suggest that administration of rhCC10 may help to facilitate development of normal airway~     epithelia and prevent the inflammation that leads to CRM in these infants.~   "
120916|NCT01473251|"~     The purpose of this study is to measure biomarkers in the vitreous of patients undergoing~     Lucentis or avastin treatment.~   "
120917|NCT01473238|"~     Paper-based data collection for prospective clinical trials is associated with a poor~     quality of data collection. This typically involves missing or wrong data entry or a low~     recruitment rate, mainly due to the cumbersome and uncontrolled data collection.~      Electronic data collection is associated with improved quality of data entry in the cases of~     Electronic Patient Records (EPR) and patient handover among doctors during night and day~     shifts. However, a comprehensive direct comparison between web-based desktop personal~     computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.~      The purpose of this prospective trial is to compare the users' experience with the web-based~     desktop PC and mobile data collection (iPad) tools.~   "
120918|NCT01473225|"~     This study is a test of possible mechanisms by which calorie labels might lead people to~     increase calorie intake. The investigators hypothesize that calorie labels might increase~     calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie~     labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people~     try to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal~     motivation toward food, causing people to eat more.~   "
120919|NCT01473199|"~     Information will be collected on the pre-op and post-op clinical status of patients with~     focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial~     Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is~     to increase the knowledge of patient outcomes such as pain, knee function, level of~     activity, and overall quality of life after treatment with the device. Patients will be~     followed for 5 years after surgery.~   "
120935|NCT01473043|"~     This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell~     variant), who have failed first line therapy. The study will recruit a maximum of 30~     patients from 2 countries including Australia and Canada. Patients will be followed up for~     efficacy, safety and health related outcomes.~   "
120920|NCT01473186|"~     Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this~     study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities~     and endometrial pathology in morbidly obese women and discover risk stratification markers~     that can potentially identify the highest risk women who might benefit from targeted cancer~     prevention strategies in a future clinical trial.~        -  Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate~          gynecologic and menstrual history with the perceived personal risk and severity of~          gynecologic cancers in a population of female bariatric surgery candidates.~        -  Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in~          morbidly obese women undergoing bariatric surgery.~        -  Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after)~          bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and~          to correlate with presence of menstrual irregularities, endometrial hyperplasia or~          cancer, and with postsurgical weight changes.~      Methods:~        -  Specific Aim 1: After informed consent is obtained, a survey and medical history of~          prospective bariatric surgery patients will be performed at the University of Virginia.~        -  Specific Aim 2: For those women who undergo bariatric surgery, study investigators will~          perform endometrial biopsies at the time of bariatric surgery on participants to~          determine the status of the endometrial lining and the potential presence of~          endometrial cancer and its precursors.~        -  Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples~          will collected for evaluation of adipocyte-related factors and correlation with~          clinical endpoints. Blood will also be collected at 6 and 12 months after surgery.~      Anticipated results: This study will identify the prevalence and correlation of menstrual~     irregularities with endometrial abnormalities and cancer in morbidly obese women as well as~     define their perceived risk of developing cancer. Serum biomarkers in obese women with and~     without endometrial cancer/precancer would be evaluated for correlation and potential~     applicability for endometrial cancer screening in this high-risk population. Most~     importantly, this study may provide evidence as to whether screening (via endometrial biopsy~     or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest~     potential preventive and risk reduction mechanisms.~   "
120921|NCT01473173|"~     The objectives of this study are:~        -  To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420~          in healthy male subjects.~        -  To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy~          male subjects.~        -  To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy~          male subjects.~        -  To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and~          esomeprazole in healthy male subjects.~   "
120922|NCT01473160|"~     The purpose of this study was to evaluate the pre-lens tear film stability of a new~     CE-marked daily disposable contact lens as compared to a commercially available daily~     disposable contact lens.~   "
120923|NCT01473147|"~     Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an~     effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2~     diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1)~     levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control.~     Nevertheless, the clinical effects and mechanisms are still unclear when additional~     supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly~     controlled Type 2 diabetes patients. This study is designed to understand the complementary~     pharmacological effects of GLP-1 analogue on intensive CSII treatment.~      Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6~     days CSII intensive treatment. Following the normalization of blood glucose at first 3 days,~     the patients are randomly assigned with combined therapy with exenatide injection or saline~     for another 3 days. The clinical assessments of insulin requirement, insulin secretion,~     insulin resistance glycemic excursions and cytokines will perform immediately during or~     after the study.~   "
120924|NCT01472107|"~     The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome~     of pregnancy in childbearing age female patients treated with chemotherapy for APL. These~     patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.~   "
120925|NCT01472094|"~     The goal of this study is to develop a bedside to bench model of clinical and biological~     predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast~     cancer. The investigators will develop a predictive model using clinical and biological~     predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast~     cancer. The investigators will also determine the association between clinical and~     biological factors and reduced relative dose intensity of the prescribed chemotherapy~     regimen. In addition, the investigators will explore specific chemotherapy toxicities~     associated with reduced relative dose intensity of a prescribed regimen.~   "
120926|NCT01472081|"~     The purpose is to determine the safety, effectiveness and best dose to use when giving~     Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of~     metastatic renal cell carcinoma.~   "
120927|NCT01472068|"~     This is a pilot clinical study taking place at one site in Berlin, Germany using~     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20~     women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days~     out of 7 set treatment program with the device. After the 12 week treatment programme the~     subjects will be asked to perform daily set exercises for a further 14 weeks.~   "
120928|NCT01472055|"~     The purpose of this study is to analysis of the pharmacokinetics of fludarabine for~     hematopoietic stem cell transplantation in pediatric patients.~   "
120929|NCT01473121|"~     This registry study is national, multi-center, prospective study without any interventions~     to the treatment strategies and/or decisions of the investigators. It is designed in order~     to determine the general profile of HCC patients in Turkey. Socio-demographic~     characteristics, family history, medical history and treatment pattern of HCC patients will~     be evaluated.~   "
120930|NCT01473108|"~     Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this~     single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in~     healthy male subjects.~   "
120931|NCT01473095|"~     This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to~     subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed~     to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and~     to define a recommended Phase 2 dose of ARQ 092.~   "
120932|NCT01473082|"~     The purpose of this study is to evaluate whether patients with trochanteric fractures being~     treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be~     mobilized than patients without augmentation.~   "
120933|NCT01473069|"~     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of~     sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also~     to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic~     profile of JTK-853 and its metabolite M2 (one cohort only).~   "
120934|NCT01473056|"~     The purpose of this study was to determine the safety, tolerability, pharmacokinetics and~     anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on~     reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by~     genotypic resistance monitoring for up to one year after study drug treatment.~   "
120936|NCT01473030|"~     The overall goal of this project is to quantify the long-term effects of dutasteride on the~     architectural and nuclear features of benign prostate tissue, using state-of-the art digital~     image analysis techniques. The ultimate result will be a multivariable morphological~     signature that could provide a useful indicator of an individual's degree of drug~     response.~   "
120937|NCT01473017|"~     This study employs a Randomised Controlled Trial design to investigate whether a CBT-based~     guided self-help intervention can improve anxiety, depression, psychological well-being,~     quality of life, Diabetic self-care and adherence; as compared to controls. The study aims~     to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety~     and depression are common in patients with Type 2 Diabetes, and has been shown to affect~     Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and~     comorbid mental ill-health, however little research has been done to date on the effect of~     guided self-help in this population. It is expected that this intervention will improve~     patient's mental health, as well as extend the limited knowledge-base on guided self-help in~     chronic illness.~   "
120938|NCT01473004|"~     The purpose of this study is to determine whether radiation provided locally to the liver~     tumor vasculature environment will demonstrate a response of tumor decline. This radiation~     may cause the tumor cells to die.~   "
120939|NCT01472991|"~     Study is to assess if TC-5619 improves symptoms for adults diagnosed with the~     inattentive-predominant subtype of ADHD over a 4-week treatment period.~   "
120940|NCT01472978|"~     The investigators found that community acquired C. diff occurs in children undergoing a~     colonoscopy. When they were treated their symptoms got better. But, the investigators do not~     know if the treatment for the C. diff made them better or another other factor made them~     feel better. So, the investigators designed the following study. Children undergoing a~     colonoscopy who are found to be C. diff positive at the time of the colonoscopy are~     randomized to one group that gets immediate treatment or a second group that gets delayed~     treatment. Both groups are closely monitored for symptoms.~   "
120941|NCT01472965|"~     Use of long-term central venous access devices (including tunneled lines and ports) can be~     associated with development of bloodstream infection caused by build-up of bacteria or~     fungus on the inside of the device, called central line associated bloodstream infection~     (CLABSI). This infection generally requires hospital admission and antibiotic therapy. This~     treatment usually helps eradicate the infection but sometimes it is not possible to clear or~     it comes back after treatment. Also, once someone has had one line infection the chance of~     getting another one is higher. This study will test whether treatment and secondary~     prophylaxis of CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of~     treatment failure (comprising failure to clear initial infection, relapse or reinfection) in~     children and adolescents treated for cancer or hematologic disorders or undergoing~     hematopoietic stem cell transplantation (HSCT). ELT involves injecting a solution of ethanol~     and water into the line or port, allowing it to dwell for 2 hours, and then withdrawing the~     solution.~   "
120942|NCT01472952|"~     Sepsis remains a common entity in critical care patients with remarkable mortality. Despite~     extended research activities, no reliable bio-markers or scoring systems attributing the~     individual risk of developing sepsis have been found so far.~      Patients with multiple trauma are at high risk of developing sepsis. Due to local and~     systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be~     found.~      Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity~     and serum cytokine levels, known as compensatory anti-inflammatory response syndrome~     (CARS) take place.~      In addition to changes of cytokine levels and immune cell activity, underlying genetic~     reactions are present. For instance, expression of miRNA (as an potential important step of~     immune cell activation) is likely changed during systemic and local immune reactions.~      In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of~     immune cell activation and the various expression of miRNA will be evaluated in patients of~     multiple trauma on day 1 and day 4.~      Additionally, clinical parameters of organ function, current infection markers as CRP and~     Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures~     delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local~     tissue perfusion will be measured with transcutaneous laser doppler.~   "
120943|NCT01472939|"~     The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor~     agonist compared to placebo on residual symptoms (regurgitation with or without heartburn)~     in subjects with GERD who have persistent symptoms while on PPI therapy.~   "
120944|NCT01472926|"~     A pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke patients~     currently eligible for intravenous alteplase treatment in a prospective, randomised, blinded~     outcome evaluation clinical trial using brain imaging as a biomarker.~   "
120945|NCT01472913|"~     The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss,~     pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect~     on Range Of Movement (ROM) and strength is examined.~   "
120946|NCT01472900|"~     Acne is one of the most common conditions that patients seek for help in dermatological~     clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics~     ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a~     satisfying result but not to every patient. Some patients are not well respond to~     conventional therapy while some patients are unable to tolerate side effects of the~     treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and~     lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and~     infrared lasers have been found to be useful in treating active inflammatory acne.~     Although,pain ,downtime and poor response of comedonal acne are limitations of those lights~     and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal~     effects is our laser of interest to seek for its efficacy in the treatment of inflammatory~     acne.~   "
120947|NCT01472887|"~     Primary Objective:~      Participants achieving an Objective Response Rate~      Secondary Objective:~        -  Progression Free Survival~        -  Overall Survival~        -  Response Duration~        -  Safety~   "
121028|NCT01471769|"~     The purpose of this study is to evaluate if an educational video viewed during the Emergency~     Department visit will improve parent knowledge of pain management, reduce parent anxiety,~     and change their use of analgesics at-home after discharge from the Emergency Department.~   "
120948|NCT01472874|"~     Hypothesis: The investigators postulate that patients with Wilson disease who are~     asymptomatic or who have been effectively treated for their symptoms and are in a~     maintenance phase therapy can be safely and effectively treated with a single daily dosage~     of the chelating agent trientine.~      Specific Aims: To demonstrate that a single daily treatment with trientine is as effective~     or better than a patient's current maintenance therapy. This will be accomplished by~     performance of a case control prospective study of patients on their prior therapy, and~     during a period of treatment with a single weight based dose regimen of trientine.~      The primary endpoint for this study is the demonstration of equivalence to a patient's prior~     therapy. Secondary endpoints include: 1) demonstration of stability or improvement in~     parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression~     of liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by~     Fibrotest).~   "
120949|NCT01472861|"~     The purpose of this study is to determine if the use of Autologous Endometrial Coculture~     (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves~     pregnancy outcome.~   "
120950|NCT01472848|"~     This study examines whether a gradual increase of dose improves the gastrointestinal~     tolerability (nausea and vomiting) of PF05212389~   "
120951|NCT01472835|"~     Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is~     well-documented that the reference standard for identifying a pain generator is a low-volume~     block performed with local anesthetic, with or without steroid. Many factors may increase~     the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of~     sedation is the most controversial and remediable. Proponents of sedation argue that it has~     little effect on the rate of positive diagnostic blocks, and may even reduce the~     false-negative rate. The purpose of this study is to determine the effect of intravenous~     sedation on pain relief and the false-positive rate after diagnostic nerve blocks.~   "
120952|NCT01472822|"~     Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in~     elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes:~     salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects~     on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous~     system, endocrine system, and stress protect. Therefore, this study is designed to evaluate~     the efficacy and safety on KO of Omija extract.~   "
120953|NCT01472809|"~     The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2)~     the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to~     the body) in the healthy and diabetic subject.~   "
120954|NCT01472796|"~     In this research study, the goal is to find out if a currently FDA-approved medication~     called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure~     and improve heart function in the African American population. High blood pressure occurs~     earlier in life in African Americans, is more severe, and is associated with greater organ~     damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very~     common in the African American population. Research has shown that there may be a link~     between low Vitamin D levels and the ability of high blood pressure medications to be fully~     effective.~   "
120955|NCT01472783|"~     The main purpose of this study is to investigate the effect of veliparib in ovarian cancer~     patients with known BRCA 1/2 mutations who do no longer respond to conventional~     chemotherapy.~   "
120956|NCT01472770|"~     The present study aims to investigate the efficacy and safety of the combination of~     capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic~     colorectal cancer.~   "
120957|NCT01472757|"~     The purpose of the study is to evaluate the clinical efficacy of three doses of VR506~     delivered via a new dry powder inhaler for the treatment of asthma.~   "
120958|NCT01472744|"~     The investigators propose to test the hypothesis that a six-month intervention of combined~     fitness and cognitive training in the form of dancing will have a significant positive~     effect on a variety of executive control and memory processes as well as brain structure and~     function as compared to a non-aerobic strength and balance control/comparison group.~     Additionally, these two groups will be compared to walking groups in which one of the~     walking groups will also be provided with a daily, liquid, milk-based nutritional~     supplement.~   "
120959|NCT01472731|"~     Brain tumors account for only 2% of all cancers but result in a disproportionate share of~     cancer morbidity and mortality. The five-year survival rates for the most common histologic~     subtypes, anaplastic astrocytoma and glioblastoma (glioblastoma multiforme, GBM), are 30%~     and 10%, respectively.~      Drugs affecting transforming growth factor-β (TGF-β) might be of great interest for~     malignant glioma treatment. TGF-β is an oncogenic factor in advanced tumors where it induces~     proliferation, angiogenesis, invasion, and metastasis as well as suppresses the antitumoral~     immune response. In addition TGF-β and its TGF-β receptors, TβRI and TβRII, are~     overexpressed in GBMs. TGF-β signaling is involved in multiple steps of GBM development.~     GC1008 is an antibody that is capable of neutralizing TGF-β and may therefore offer a new~     treatment option for patients with malignant glioma.~      For therapeutic success, it may be essential for GC1008 to reach the target site, in this~     case located in the brain. We will be able to prove this with 89Zr-GC1008 PET imaging. This~     imaging method also allows quantification of the amount of GC1008 reaching the tumor.~      This study consists of 2 parts. In part 1, patients with a suspicion of a malignant glioma~     undergo an 89Zr-GC1008 PET scan before standard (surgical)treatment. In part 2, patients~     with relapsed malignant glioma will undergo an 89Zr-GC1008 PET scan and will be treated with~     GC1008 in a phase II study as there is no standard treatment for these patients.~      We hypothesize that GC1008 uptake in brain tumors can be visualized and quantified using the~     89Zr-GC1008 PET scan and GC1008 might offer a new treatment option for patients with~     relapsed malignant gliomas.~   "
120979|NCT01472471|"~     Oxidative stress is seen in children with asthma, but is hard to measure. The investigators~     exploring the utility of using a commercially available assay to measure oxidative stress in~     the urine in asthmatics. Additionally, the investigators will attempt to prove that~     oxidative stress is higher in children with acute asthma compared to those with stable~     asthma and that this stress is also higher in children with more severe clinical asthma~     exacerbations compared to less severe ones.~   "
120960|NCT01472718|"~     200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms~     and having a high thrombotic burden at coronary angiography, defined as the presence of a~     thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main~     objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or~     manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with~     angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1)~     rate of complete ST-segment elevation resolution at 60 minutes after the end of the~     procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance~     imaging (DE-MRI) at 3 months after the index procedure.~      Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct~     transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.~   "
120961|NCT01472705|"~     This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with~     biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer~     through 3 years of follow-up.~   "
120962|NCT01472692|"~     High normal blood pressure, also called prehypertension, is a significant problem. High uric~     acid in the blood, the same thing that causes gout, may cause higher blood pressures. The~     investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood~     pressure and stiffness of the main blood vessels and see if lowering uric acid has any~     effect.~   "
120963|NCT01472679|"~     The purpose of this study is to evaluate whether body composition is associated with a~     higher risk of mortality in subjects ≥ 65 years.~   "
120964|NCT01472666|"~     Dairy food contains a large amount of long-chain saturated fat, which traditionally has been~     linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a~     more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids~     (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and~     in particular whey proteins have been shown to have a beneficial effect on glucose disposal~     as well as anti-inflammatory properties. Therefore dairy products have a potential role in~     the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human~     data from intervention studies are lacking.~      Aims of this project is to explore and understand the influence on human health of both~     medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well~     as their interaction and potential positive synergy on the MeS.~      The investigators hypothesize that whey protein and medium-chain saturated fatty acids~     improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory~     stress in humans and that they possess preventive effects on the risk of developing CVD and~     type 2 diabetes mellitus (T2DM).~      A total of 64 people with MeS or abdominal obesity will be included. The design is a~     randomized double-blinded, controlled parallel diet-intervention trial.~      Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of~     either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA +~     whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets~     with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to~     integrate the test foods in their habitual diet, which also continues unchanged. The~     subjects' energy intake is matched so they are kept weight stable throughout the study.~   "
120965|NCT01472653|"~     The therapy of patients with locally advanced head and neck cancer will be adjusted to the~     grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e.~     either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy~     (radiotherapy and Cisplatin.~   "
120966|NCT01472640|"~     Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic~     control in patients with the combination of T2D and CHF is complicated and the currently~     available treatments have proven to be inadequate in clinical trials.~      Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular~     ejection fraction (LVEF) in CHF patients with and without T2D.~      Multicenter, randomized, double blind study of 240 patients with documented systolic CHF~     (50% with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic~     and diastolic function will be evaluated by advanced echocardiography~      Primary outcome parameter is change in LVEF from visit 1 to week 24.~   "
120967|NCT01472627|"~     The purpose of this study is to better understand what effects Bortezomib, a drug used for~     multiple myeloma therapy, has on the immune system.~   "
120968|NCT01472614|"~     This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and~     safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile,~     and adiponectin in subjects with type-2 diabetes mellitus.~   "
120969|NCT01472601|"~     This study is a parallel translational study of a Randomized Phase III trial Investigating~     the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as~     Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol~     NCCCTS-467) . Patients participating in the trial will be provided with the informed consent~     of this parallel study, and peripheral blood and tumor tissue of those who signed the~     consent will be collected for germline polymorphism analysis and gene expression profile~     study .~   "
120970|NCT01472588|"~     Obesity is a significant and growing problem in the US that negatively impacts health and~     well-being of racial and ethnic minorities, people of low socioeconomic status, and persons~     living in rural communities and in the South. Obesity is a major concern in Arkansas, where~     the obesity rate for adults is higher than the rate for other adults in the nation. However~     effective weight loss programs are not typically available in these communities. Research~     has shown that the Diabetes Prevention Program (DPP) lifestyle intervention is effective in~     promoting weight loss in high risk individuals through changes in diet and physical activity~     that significantly reduce the chances of type 2 diabetes. Effective methods are desperately~     needed to translate the DPP to community settings, where obesity is a compelling public~     health burden. A major step in translating the DPP is to examine the efficacy of health~     professionals and community health workers (CHWs) in delivering the program in real-world~     settings. This is an important issue from the perspective of how evidence-based weight loss~     interventions can be provided to underserved, and resource constrained communities that~     typically may not have access to trained professionals for program delivery. The current~     project is a 5 year randomized controlled trial that examines DPP delivery and weight~     outcomes for individuals randomly assigned to either: (1) the DPP intervention delivered by~     CHWs or (2) the DPP intervention delivered by health professionals or (3) the Self Help~     condition. The study population consists of overweight adults (body mass index (BMI) > 25)~     who reside in communities with a high proportion of African Americans. Primary outcome is~     change in body weight at 16 months. Cost effectiveness and lifestyle behaviors are also~     evaluated.~   "
121010|NCT01472003|"~     This is an open label study designed to evaluate the biodistribution and imaging~     characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.~   "
120971|NCT01472575|"~     This project aims to assess the impact of rotavirus vaccine introduction on severe~     gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations~     and all-cause gastroenteritis hospitalisations will be compared for a two year period prior~     to introduction of the vaccine and a two year period following introduction of the vaccine.~     Severity of rotavirus coded admissions during the periods will also be assessed.~      Hypotheses:~        1. Introduction of the rotavirus vaccine will result in an 80% reduction in~          hospitalisations for rotavirus positive gastroenteritis (ICD code A0.80) in children~          less than two years of age.~        2. Introduction of rotavirus vaccine will result in an 80% reduction in Paediatric~          Emergency presentations for rotavirus positive gastroenteritis in children under two~          years of age.~        3. Introduction of the rotavirus vaccine will result in a 50% reduction in~          hospitalisations for all cause gastroenteritis (ICD codes A0.00-A0.90) in children less~          than two years of age.~        4. Introduction of the rotavirus vaccine will result in a 50% reduction in Paediatric~          Emergency presentations for all cause gastroenteritis in children less than two years~          of age.~        5. Introduction of rotavirus vaccine will result in a reduction in hospitalisation and~          Paediatric Emergency presentations in children aged four and five years with rotavirus~          positive gastroenteritis (unvaccinated cohort).~        6. There will be no difference in severity of disease as scored by the Vesikari and/or~          clark severity score prior to and post introduction of rotavirus vaccine~   "
120972|NCT01472562|"~     This is a phase II, multicenter study to determine the efficacy and safety of first-line~     lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received~     no prior systemic therapy.~   "
120973|NCT01472549|"~     The investigators propose a randomized controlled clinical trial to determine the~     comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin~     preparation for preventing surgical site infections at cesarean section. While estimates~     vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result~     in significant human suffering and excess health care costs. Interventions such as~     preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of~     infection remains high. There is therefore a great need to identify and test other potential~     interventions to further reduce these infections.~      The skin is a major source of pathogens that cause surgical site infection. Therefore,~     optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical~     site infections. There is paucity of evidence to guide the choice of antiseptic for skin~     preparation at cesarean section. To date, only two underpowered trials have been published~     comparing two methods of preoperative skin preparation at cesarean section. A recent~     randomized trial in adults undergoing clean-contaminated mostly general surgical procedures~     demonstrated a 41% reduction in surgical site infection with the use of~     chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is~     plausible that findings from trials in other clean-contaminated surgical procedures may~     apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial~     source for cesarean-related infections and the hormone-mediated immune-modulation in~     pregnancy make the validity of such extrapolation uncertain.~      The study has the following specific aims:~      Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation~     at cesarean section significantly reduces surgical site infections compared to~     iodine-alcohol.~      Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin~     preparation at cesarean section significantly reduces bacterial contamination at the~     surgical site compared to iodine-alcohol.~      Secondary Aim 2: To determine clinical outcomes and medical costs associated with~     cesarean-related infections and quantify potential cost savings attributable to use of~     chlorhexidine-alcohol for preoperative skin preparation at cesarean section.~   "
120974|NCT01472536|"~     Much of community transmission of seasonal and pandemic influenza occurs in younger~     individuals, because of their susceptibility and their social interaction~     patterns.Universities are places where transmission of influenza is facilitated because of~     the age of individuals involved, their close contact with each other, and low vaccination~     coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified~     as one of the most efficient ways to reduce influenza transmission, but there are still~     insufficient data on the effects of social distancing to be able to make recommendations for~     future pandemics or even outbreaks of seasonal influenza.~      The investigators are conducting a study on the effect of voluntary sequestration during~     illness on the transmission of influenza among social networks in University residence~     housing units at the University of Michigan. The sequestration interventions will be carried~     out during a period of influenza transmission that is defined by surveillance conducted at~     the University Health Service. Data will be collected on use of the interventions and the~     occurrence of influenza and other illnesses. In all selected residence halls, specimens will~     be collected when illness meeting a case definition for influenza-like illness occurs.~      This study in a university population will evaluate the acceptability and magnitude of~     effect that can be expected from such an intervention, and determine the number of days that~     sequestration should be practiced.~   "
120975|NCT01472523|"~     A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and~     the presence of trisomies using a novel method.~   "
120976|NCT01472510|"~     This study is designed to confirm that the investigational drug Ranibizumab given by~     injection into the eye is safe and effective to use in people with diabetic macular edema~     (DME).~   "
120977|NCT01472497|"~     Insulin resistance is often complicated with hypertension. AGE and inflammation play~     important roles in insulin resistance. Some studies reported that pioglitazone, insulin~     sensitizer, is effective for patients with insulin resistance, however, the mechanisms are~     still unclear. The aim of this study to evaluate the effect of pioglitazone compared with~     glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in~     hypertensive patients during oral glucose tolerance test.~   "
120978|NCT01472484|"~     Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have~     the potential to alleviate iron bioavailability problems associated with PA. These plants~     have normal phosphate levels, but reduced PA phosphate due to various modifications of the~     biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of~     them exhibiting reduced yield and seed germination. However, the lpa bean isolated by~     Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean~     PA concentration without any defects in terms of growth and yield.~      Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the~     development of a variety which has the potential to improve the iron status of bean~     consuming populations.~      The following study will evaluate the relative impact of PA and PP on iron absorption from~     beans by comparing iron absorption from four different bean varieties. Iron absorption from~     a bean with normal PA concentration and high PP concentration will be compared to iron~     absorption from a bean with normal PA and low PP concentration as well as to two lpa~     varieties, one with high and one with low PP concentration.~   "
121027|NCT01471782|"~     The purpose of this study is to determine the dose of the bispecific T cell engager~     blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute~     lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.~   "
120980|NCT01472458|"~     The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on~     using innovative knowledge translation strategies to improve appropriate~     neuroprognostication for survivors of cardiac arrest and prevent premature termination of~     life sustaining therapies. This is important because any early gains achieved during~     resuscitation will be nullified if clinicians terminate life-sustaining therapies~     prematurely based on inadequate prognostic information. An effective translation strategy~     for neuroprognostication will result in improved physician adherence to evidence-based~     medicine and an increase in the proportion of patients surviving to achieve a good~     neurological outcome following cardiac arrest.~   "
120981|NCT01472445|"~     This is a research study of the effect of Vitamin D on breast cancer. We hope to learn~     whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that~     affect its growth. We believe some of these characteristics may be influenced by body~     weight.~   "
120982|NCT01472432|"~     A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4~     months of vildagliptin on healing of chronic ulcers in type 2 diabetes.~   "
120983|NCT01472419|"~     Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of~     relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of~     effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who~     are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP)~     chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients~     were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as~     first-line chemotherapy. Clinicopathologic variables and treatment outcome were~     retrospectively collected. we analysis treatment outcome of palliative chemotherapy in~     metastatic esophageal squamous cell carcinoma and make prognostic scoring system. The~     present study represents the largest series to analyze the treatment outcome of FP/XP~     chemotherapy in metastatic SCC. Risk-adapted stratification of treatment for subgroup of~     metastatic SCC patients should be actively pursued.~   "
120984|NCT01472406|"~     This clinical trial is a feasibility study to assess the performance of an Artificial~     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with~     type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp,~     San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring~     System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP~     device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a~     safety algorithm named the Health Monitoring System (HMS). The clinical study will include~     12 to 20 adults subjects aged 21 to 65 years old.~   "
120985|NCT01472393|"~     Animal, in vitro and small-scale studies have suggested that creatine supplementation may~     augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine~     supplementation protocol on bone mass in postmenopausal women.~   "
120986|NCT01472380|"~     Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an~     inhibitor of CYP2B6. This study will evaluate the effect of multiple doses of fenofibric~     acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult~     subjects.~   "
120987|NCT01472367|"~     The purpose of the study is to assess the safety of the addition of sitagliptin, and its~     effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients~     requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with~     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone~     or in combination with insulin). The primary hypothesis is that the addition of sitagliptin~     reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who~     complete the 20-week base period of the study may choose to participate in the extension~     period of the study and continue on or off treatment assigned during the base period for an~     additional 34 weeks.~   "
120988|NCT01472354|"~     The purpose of the LEAP-C (learning, experiencing and preparing for hepatitis C treatment)~     study is to see if a brief (4-week) small group intervention will help people with HIV/HCV~     co-infection make an informed decision about Hepatitis C treatment.~   "
120989|NCT01472341|"~     The purpose of this study is to evaluate the degree of beta-cell dysfunction among~     participants with type 2 diabetes and the association between beta-cell dysfunction and~     demographic, clinical, and treatment variables.~   "
120990|NCT01472328|"~     Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin~     sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in~     patients.~   "
120991|NCT01472315|"~     The purposes of this study are to evaluate the degree and duration of medroxyprogesterone~     acetate effect as well as tolerability in postmenopausal women with nasal continuous~     positive airway pressure (CPAP) treated sleep apnea and to compare the effects with nasal~     CPAP.~   "
120992|NCT01472302|"~     Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like~     PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU~     patients. The investigators hypothesized that using ASV from the beginning of intubation can~     reduce the total duration of MV and LOS in the ICU when compared to conventional modes such~     as PCV+PSV~   "
120993|NCT01472289|"~     The purpose of this study is to evaluate the safety and efficacy of the concentrated~     autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia~     patients.~   "
120994|NCT01472276|"~     Web- or internet-based programs have the potential to induce and, possibly, help to sustain,~     significant lifestyle modification. This study will evaluate the effect of a unique~     interactive web-based behaviour change program on weight loss and cardiovascular risk~     factors in people who are overweight or obese and at high risk of cardiovascular disease.~   "
120995|NCT01472263|"~     In this study the investigators are going to evaluate the efficacy pentoxifyline in HTLV-1~     patients with neurological diseases: HAM/TSP or neurogenic bladder. In some laboratory~     experiments the investigators observed that this drug had the capacity to reduce the immune~     response in HTLV-1 infected cells. Since the exacerbated immune response is know to cause~     neurological disease in patients with HTLV-1 the investigators hope that pentoxifyline can~     alleviate symptoms and delay the progress of HAM/TSP in patients.~   "
120996|NCT01472250|"~     This is a multi-center, prospective and observational clinical study. Eligible patients will~     accept generalized chemotherapy according to the investigator's assessment. Information~     related to the treatment, including medication, disease condition, expenses, etc. will be~     periodically collected. Follow-up at 2-month intervals will be periodically performed to~     continually collect information about the disease progression, subsequent treatment and~     survival until death or completion of the study.~      Recruited patients will fill out questionnaires about quality of life before initiation of~     treatment, at Cycle 3 and completion of first-line treatment.~   "
120997|NCT01472237|"~     The purpose of this study is to determine whether a modification of the diet of malnourished~     patients admitted for heart failure is beneficial in term of mortality,hospitalizations and~     quality of life.~   "
120998|NCT01472224|"~     This study investigates the ability of ultrasound to measure the volume of a brain~     hemorrhage in the acute phase after hospital admission.~      It is known that approximately 30% of patients admitted with a brain hemorrhage will suffer~     from enlargement of the hematoma within the first hours after admission.~      In this study the investigators measure the volume of the hematoma every 30 minutes up to 6~     hours after admission and every 2 hours between 6-12 hours.~   "
120999|NCT01472211|"~     The overall aim of this trial is to determine whether the use of the household-based water~     treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status~     and health status of vulnerable populations in developing country rural settings with poor~     access to potable water.~      To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc~     enriched water) a double blind controlled field efficacy trial will take place over a period~     of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to~     attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc~     enriching filter), placebo (filter) and control group (disinfection tables). During the~     trial the following outcomes will be monitored: zinc status and growth rate of the~     participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women~     (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality,~     zinc enrichment of water, and modality and consistency of use of the LSF-device by the study~     population.~      The study hypotheses are: 1) the use of the LSF-device will reduce microbiological~     contamination of the household water, 2) the use of the LSF-device will increase zinc~     intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device~     will increase zinc intakes and serum zinc concentration in pregnant women, 4) the~     achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea~     episodes in participating preschool children, 5) the achievement of 1 and 3 will improve~     pregnancy outcome and lower frequency and length of diarrhea episodes in participating~     pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea~     episodes in participating households members.~   "
121000|NCT01472198|"~     This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination~     with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be~     comprised of 2 sequential parts: an open label treatment phase and a double-blinded~     treatment phase.~   "
121001|NCT01472185|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study~     to determine the effect of ranolazine when given as monotherapy on glycemic control in~     subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and~     exercise alone and who are treatment naive to antihyperglycemic therapy or have not received~     antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24~     weeks) prior to screening, and to characterize the relationship between HbA1c reduction and~     other glycemic parameters in subjects with T2DM.~   "
121002|NCT01472172|"~     The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe~     during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on~     bleeding intensity.~   "
121003|NCT01472159|"~     The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a~     family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained~     continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize~     that CGM implemented with a family-focused, behavioral teamwork intervention will result in~     sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.~   "
121004|NCT01472146|"~     The purpose of this study is to evaluate the association of zoledronic acid with standard~     treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast~     cancer HER 2 positive.~   "
121005|NCT01472133|"~     Continuous accurate unobtrusive respiratory rate monitoring may lead to improved patient~     outcomes, as respiratory rate is thought to be a sensitive marker of patient deterioration.~     Currently systems are not suitable for long term monitoring, particularly in ambulant~     patients as they are too restrictive. To ensure that our algorithms are suitable for use in~     a clinical context we need to demonstrate their performance not only in the optimal~     situation, healthy volunteers at rest, but also in more challenging situations such as where~     the person being monitored is moving and also in patients who have conditions which may~     affect their physiology in such a way that the accuracy of the respiration rate estimation~     may be affected.~      No previous study has systematically tested algorithms deriving respiratory rate from either~     the ECG or the photoplethysmography (PPG) waveforms in a real -world setting.~      The algorithms work by looking for changes in intervals between heartbeats and also changes~     in the sizes of the ECG and PPG waveforms, both of which may be caused by respiration. These~     changes tend to diminish with increasing age and also conditions which alter the chest~     movement and cardiac reflexes. Thus it is important to test our algorithms' accuracy in~     participants exhibiting these conditions. It is also important to ensure that the~     calculations of respiratory rate are accurate across a range of heart rates and respiratory~     rates. Our testing covers all these variables.~   "
121006|NCT01472120|"~     In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory~     M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype~     in various metabolic disorders such as obesity and type 2 diabetes mellitus.~   "
121007|NCT01472042|"~     The purpose of this study is to study the biomarkers in subjects before and after~     sports-induced traumatic brain injury. The assay will be studied in a sample population of~     subjects over the age of 18 participating in college sports.~   "
121008|NCT01472029|"~     The purpose of this study is to determine the rate of complete pathological responses~     (percentage of patients with pCR referring to the total number of enrolled and eligible~     patients), as evaluated centrally by a reference pathologist.~   "
121009|NCT01472016|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET~     amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications,~     is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the~     activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.~   "
121011|NCT01471990|"~     The purpose of this study is to examine and compare the effect of pituitary adenylate~     cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on~     intracranial arteries and neuronal activity in patients with migraine without aura using a~     high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and~     functional MRI (fMRI).~      MRA will be used to detect changes in intracranial artery circumferences before and after~     PACAP38 and VIP.~      fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal~     (BOLD-signal).~      PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine~     specific drug sumatriptan will be given to relieve pain and the effect will also be~     registered using MRA and fMRI.~   "
121012|NCT01471977|"~     It was hypothesized that tuberculosis patients receiving multiple interventions like~     educations, counseling and default tracing along with DOTS were more likely to adhere to~     tuberculosis treatment as compared to few interventions or DOTS only.~   "
121013|NCT01471964|"~     This phase I/II trial studies the side effects and the best dose of MLN8237 when given~     together with erlotinib hydrochloride and to see how well it works in treating patients with~     recurrent locally advanced or metastatic non-small cell lung cancer (NSCLC). MLN8237 and~     erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
121014|NCT01471951|"~     Embryo selection based on the use of morphometric parameters should increase the~     implantation success rate.~      One of the most important issues of Assisted Reproduction Technologies (ART) is the~     possibility of multiple pregnancies which carries a significant risk for maternal-fetal~     health. These risks can be reduced by restricting the number of embryos transferred.~      To do this, it is essential to improve current techniques of embryo selection by developing~     new tools that would allow the selection of the embryos with higher implantation potential.~     In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy~     for the embryo classification systems based on the use of the morphometric variables. The~     investigators have also developed a profile of embryo implantation using these morphometric~     variables. In this project the investigators intend to validate the clinical validity of~     this new embryo classification system by conducting a prospective study of single embryo~     transfer (SET) in young women at risk of multiple pregnancies.~   "
121015|NCT01471938|"~     The aim of the study is to apply and adapt device specific body composition formulas to~     various ethnic groups. Bases are prediction equations that are generated in the clinical~     investigation Generation of prediction equation to analyze body composition of adults based~     on Bioelectrical Impedance Analysis (BIA). The study bears the code BCA-01.~   "
121016|NCT01471925|"~     A phase III, randomized, open-label, superiority study comparing the incremental product~     esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the~     treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm~     (total of 188 patients).~   "
121017|NCT01471912|"~     In our experience, elongation of foveal tissue after macular hole surgery which was~     undetectable by conventional time-domain optical coherence tomography was often observed on~     spectral-domain optical coherence tomography images. Elongation of tissues inevitably~     induces some degree of disorganization of tissue microstructure.~      The purpose of the present study was to evaluate elongation profile of foveal tissue after~     macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.~   "
121018|NCT01471899|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drugs in the treatment of patients diagnosed with moderate to severe back pain~     treatment.~   "
121019|NCT01471886|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two~     different drugs in the treatment of patients diagnosed with moderate to severe back pain.~   "
121020|NCT01471873|"~     Primary objective of this study was to assess the intrasession, intersession and~     interobserver variability of the Pentacam-derived posterior corneal elevation measurements~     in keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment~     due to progressive keratoconus.~   "
121021|NCT01471860|"~     The purpose of this clinical investigation is to evaluate the efficacy and safety of the~     CVRx Barostim Neo System in the treatment of patients with heart failure.~   "
121022|NCT01471847|"~     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with~     patients that have locally advanced or metastatic HER2+ breast cancer. The first part (phase~     Ib) will investigate the MTD/ RP2D of the combination therapy of BEZ235 BID and weekly~     trastuzumab using a Bayesian model. Once MTD/ RP2D is established the second part (phase II)~     will start. Phase II will evaluate the efficacy and the safety of weekly trastuzumab plus~     BEZ235 BID compared to capecitabine and lapatinib.~   "
121023|NCT01471834|"~     The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx~     Barostim Neo System in the treatment of resistant hypertension.~   "
121024|NCT01471821|"~     This is a prospective, open controlled trial in which HIV-1 with viral suppression patients~     will be randomized to continue with their current treatment (lopinavir/ritonavir plus~     emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or~     to simplify to lopinavir/ritonavir plus lamivudine.~      Randomization will be stratified according to the values of nadir CD4 and time of viral~     suppression.~   "
121025|NCT01471808|"~     The purpose of this study is to investigate and evaluate the effects of different oral~     antihyperglycaemic agents combined with short-term continuous subcutaneous insulin~     infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin~     combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed~     type 2 diabetic patients.~   "
121026|NCT01471795|"~     Infections often occur after ventricular assist devices (VADs) are placed. These infections~     can be very serious. The goal of this study is to understand why these infections occur.~     Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect~     the VAD. The investigators will collect cultures of your skin and nose before and after~     surgery. The investigators will compare these bacteria to bacteria that cause infections.~     Their genes will be compared to see which ones help the bacteria cause infection.~   "
121029|NCT01471756|"~     The investigators seek to compare two techniques of removing pre-cancerous lesions from the~     colon. The investigators also will compare two solutions used during the procedure to~     determine if either solution allows for an improved removal of the tumors.~   "
121030|NCT01471743|"~     Surgical patients are high risk for post operative infections. These post operative~     infections contribute to increased length of hospital stay, hospital costs and delay overall~     recovery time thus decreasing the quality of life. Studies have reported post operative~     complications ranging from 37% to 74%.1 The most costly complications include infectious~     complications after major Gastrointestinal (GI) surgery including wound infections,~     abdominal abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been~     conducted that show a significant reduction in infectious complications and average length~     of stay when treated with immunonutrition supplements.2-3 A review of similarly designed~     studies in a different patient population indicate that post-operative infections can be~     reduced by an average of 71% with immunonutrition.~      This study seeks to investigate the effect of Impact Advanced Recovery ® in improving~     surgical outcomes in patients receiving major gastrointestinal surgeries compared to a~     standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery~     ® may decrease post-operative infectious complications, length of stay, and recovery time.~      Hypothesis~        1. In patients receiving elective gastrointestinal surgery (esophageal, gastric,~          pancreatic or colon resections) there will be a significant decrease of at least 60% in~          post-operative infections as listed below for patients who consume 15 servings of~          Impact Advanced Recovery® pre-operatively compared to patients who consume 15 servings~          of a standard supplement.~           Complications to be considered: anastomatic leak, post-op wound development, post-op~          abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction,~          urinary tract infections, peritonitis or bowel necrosis.~        2. In patients receiving elective gastrointestinal surgery (esophageal, gastric,~          pancreatic or colon resections) there will be a significant decrease in hospital and~          NPO days for patients who consume 15 servings of Impact Advanced Recovery ®~          pre-operatively.~   "
121031|NCT01471730|"~     Prospective, randomized, double blind trial. The rationale of the study is the concept that~     fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that~     prothrombin complexes and fibrinogen are available.The experimental hypothesis is that~     cardiac surgery patients may be operated with no use of FFP and with a coagulation factors~     replacement based on fibrinogen and prothrombin complexes (when needed).~      Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive~     blood transfusion, bleeding.~      Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60~     patients each~   "
121032|NCT01471717|"~     This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction~     between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).~   "
121033|NCT01471704|"~     The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug~     interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL~     ER).~   "
121034|NCT01471691|"~     This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular~     edema secondary to retinal vein occlusion in patients that have previously failed treatment~     with other macular edema treatments including bevacizumab.~   "
121035|NCT01471678|"~     This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a~     fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)~     relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride~     0.2 mg tablets or capsules. Two fixed dose combination capsules will be tested; one will~     contain tamsulosin hydrochloride pellets with a 15% enteric coating, and the other~     tamsulosin hydrochloride pellets with a 10% enteric coat. In addition, two formulations of~     tamsulosin hydrochloride will be tested in the co-administration with dutasteride 0.5 mg; a~     0.2 mg oral disintegrating tablet and a 0.2 mg hard shell capsule. This will be an~     open-label, randomized, single dose, four-period crossover in healthy male subjects of North~     East Asian ancestry. Subjects will receive single oral doses in four treatment periods, each~     separated by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be~     taken at regular intervals after dosing. Safety will be assessed by measurement of blood~     pressure, heart rate and review of adverse events. The study will enrol approximately 30~     healthy male subjects to ensure that 24 complete the study.~   "
121036|NCT01471665|"~     The purpose of this study is to investigate the effect on repeat doses of GSK2190915 in~     asthmatic patients with a high percentage of neutrophils in their sputum. GSK2190915 will be~     given as an add on to current therapy, and its effects on the percentage of sputum~     neutrophils in the patients will be assessed.~   "
121037|NCT01471652|"~     The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective~     therapy has been developed. Recent studies suggest that a preceding viral infection causes~     mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible~     individuals. There is no specific laboratory test to identify patients with CFS. However,~     certain clinical manifestations are similar to those seen in mitochondrial disorders. Both~     patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after~     exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain~     glutathione levels on nuclear magnetic resonance (NMR) spectroscopy.~      Therapy consisting of daily conditioning exercise, dietary recommendations, and~     nutraceutical supplements (ENT) has been show to be beneficial in treating patients with~     mitochondrial disorders. Similar therapy has been instituted in individual patients with CFS~     and has been shown to also improve their clinical conditions.~      A placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients~     fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical~     causes for fatigue will be excluded. Half the patients will receive treatment consisting of~     daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be~     beneficial for patients with mitochondrial dysfunction, while the other half will receive~     daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by~     maximum oxygen consumption (VO2max) and circulating lactate levels during & after treadmill~     exercise, a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT~     corrects the elevated brain cerebrospinal fluid levels and decreased brain glutathione~     levels will be measured. To ensure compliance to therapy patients will be monitored~     frequently. The objective of this study is to assess the safety and efficacy of ENT and~     whether ENT leads to sustained improvement of CFS patients compared to their baseline~     status, and compared to an exercised group of patients not receiving supplements.~   "
121038|NCT01471639|"~     The purpose of this study is to determine the effectiveness, the safety, and the~     tolerability of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-64~     who come to the ED seeking care. Considering all ED visits, pain is the most common chief~     complaint. Giving intranasal ketorolac (Sprix) after stomach and dental surgeries has been~     shown to be safe and effective, but no studies have investigated the use of intranasal~     ketorolac (Sprix) for the treatment of acute pain in the ED.~      Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including~     opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The~     administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and~     oral pill form, has been shown to be safe and effective in treating acute pain.~      This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal~     spray will have the same benefit in decreasing patient's pain.~   "
121039|NCT01471626|"~     The purpose of this study is to develop an efficient home-based polysomnography device,~     which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the~     hospital, in order to decrease the failure rate of home-based recordings.~   "
121040|NCT01471613|"~     The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical~     cord blood mononuclear cell transplant, and the combination in the treatment of acute and~     subacute spinal cord injury~   "
121123|NCT01470521|"~     The purpose of this study is to determine whether people with MS who are exposed to a small~     number of hookworms will have less inflammation and less MS disease activity.~   "
121041|NCT01471600|"~     In several national anaesthesia societies, clear fluids are allowed up to 2 hours before~     general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict~     fasting remains routine. Recently, surgical studies proved that pre-operative~     carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid~     volume and acidity.The aim of this study was to show the effects of preanaesthetic oral~     fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a~     reduction of the preoperative discomfort. The investigators thus propose a randomised~     prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in~     patients undergoing upper endoscopy without emergency. Study compare two groups : group~     drink (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before~     the induction of anaesthesia) and group overnight fasting.Discomfort was measured at 2~     hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item~     (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue~     scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist~     assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of~     this study was to assess in patients referred for upper endoscopy under general anaesthesia,~     the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to~     compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of~     side effects. 118 patients will be included in the study. A stratification will be made on~     the type of endoscopy.~   "
121042|NCT01471587|"~     Skeletal muscle is composed of two fibre types which are intertwined. Skeletal muscle~     weakness, particularly of the walking muscles, is an important complication of Chronic~     Obstructive Pulmonary Disease (COPD) but so far the investigators do not know what~     mechanisms drive the process.~      All existing studies have investigated signalling pathways in the whole muscle so they have~     been forced to consider type I and type II fibres together. It is possible that disease~     selectively affects one fibre type, most likely type I fibres which are in fact lost in COPD~     patients. For this reason mechanisms of disease may have been overlooked by current studies.~      The applicants have acquired the technology which allows type I and type II fibres in a~     muscle specimen to be split (by laser capture microdissection) and so signalling pathways~     can be assessed separately in type II and type I fibres which is what this proposal sets out~     to do.~      The proposal therefore aims to capture well characterised clinical data from 60 COPD~     patients and 20 age matched controls, from whom a biopsy of the main walking muscle, the~     quadriceps, will be taken. In the samples the investigators will assess at a fibre specific~     level inflammatory signalling. Surplus material will be retained for subsequent fibre~     specific analysis.~   "
121043|NCT01471574|"~     The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir~     plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients~     coinfected with HIV~   "
121044|NCT01471561|"~     This is a retrospective study to determine if rates of osmolarity and dry eye disease~     symptoms increase following cataract surgery.~   "
121045|NCT01471548|"~     The purpose of in this study is to assess the safety profile and estimate the maximum~     tolerated dose of TKI258 in Japanese patients.~   "
121046|NCT01471535|"~     Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of~     chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive~     carriers.~      The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface~     antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine~     aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who~     would not generally be considered candidates for therapy.~   "
121047|NCT01471522|"~     The purpose of the ISCHEMIA trial is to determine the best management strategy for~     higher-risk patients with stable ischemic heart disease. This is a multicenter randomized~     controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia~     on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV)~     with cardiac catheterization (cath) followed by revascularization plus optimal medical~     therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization~     reserved for those who fail OMT.~      SPECIFIC AIMS~      A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial~     invasive strategy of cardiac catheterization followed by optimal revascularization, if~     feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular~     death or nonfatal myocardial infarction in participants with SIHD and at least moderate~     ischemia over an average follow-up of approximately 4 years compared with an initial~     conservative strategy of OMT alone with catheterization reserved for failure of OMT. The~     primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal~     myocardial infarction.~      B. Secondary Aims Major: To compare angina-related quality of life between groups. Other~     secondary aims include: a) comparing the incidence of all-cause death; the components of the~     primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or~     hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke;~     and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for~     unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups;~     and b) comparing health resource utilization, costs, and cost-effectiveness between groups.~      Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac~     catheterization Phase: Phase III~      Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous~     Coronary, other catheter-based interventions Phase: Phase III~      Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III~   "
121048|NCT01471509|"~     The purpose of this study is to determine the effect of various foods and/or food substances~     such as fats or proteins on the blood glucose and insulin concentrations in people with and~     without type 2 diabetes.~   "
121049|NCT01471496|"~     The purpose of this study is to determine whether prophylactic injection therapy reduces~     recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent~     bleeding.~   "
121050|NCT01471483|"~     Older woman with ovarian cancer have a worse prognosis compared to younger patients.~     However, the reason is not known. Currently, the standard of care is to evaluate younger and~     older patients with cancer the same way. However, older patients with cancer often have more~     complicated issues to manage. For example, older patients often have other medical problems,~     take more medications, and be dependent on others for help and transportation. Too often,~     the medical team is unaware of these issues which can effect the patients care.~      The purpose of this study is to apply a set of questions designed specifically for patients~     with cancer who are older than 65 years of age. These questions are called a geriatric~     assessment.~      The investigators want to better understand which older patients with ovarian cancer will be~     able to tolerate the chemotherapy and surgery and why. This study will also see if a~     telephone call from a nurse who specializes in caring for older patients will improve~     patient care. This study will determine how feasible it is to perform geriatric assessments~     and telephone calls in patients with ovarian cancer.~   "
121051|NCT01471470|"~     The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and~     bevacizumab are effective in the treatment of unresectable advanced gastric cancer.~   "
121052|NCT01471457|"~     The primary objective of this prospective, randomized, controlled study is to assess the~     effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use~     pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for~     >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not~     using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis~     (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and~     effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post~     pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly~     affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and~     Gram stain, but will have a positive effect on the subjective symptoms experienced by women~     wearing pessaries.~   "
121053|NCT01471444|"~     The goal of this clinical research study is to learn if combining busulfan with clofarabine~     and fludarabine can help control the disease better than the previous standard method (using~     busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination~     therapy will also be studied.~   "
121054|NCT01471431|"~     The objective of this study is to determine whether use of the spontaneous breathing trial~     allows for earlier successful extubation of very low birth weight (VLBW) infants who are~     intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).~   "
121055|NCT01471418|"~     Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an~     estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent~     of the patients who seek care for one of these conditions, will go on to develop chronic~     pain. The two most common TMD conditions include myofascial pain disorder and internal~     derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical~     presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam~     or test to differentiate between these two conditions.~      Internal derangement of the TMJ is a condition with disk displacement, pain, and~     dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is~     self-limiting for the majority of the patients afflicted, with a small minority progressing~     to advanced joint destruction, disability and chronic pain.18 Currently there are no~     prognostic indicators to identify these individuals. There are three hypothesis of~     degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion~     injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching~     or grinding by the patient and a low-grade inflammatory response/synovitis.~     18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET)~     and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as~     recently demonstrated in several pilot studies involving osteoarthritis of the knee and~     shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated~     leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique~     advantage of showing active disease before anatomic damage is evident. Our hypothesis is~     that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.~   "
121056|NCT01471405|"~     This non-interventional retrospective study aims to describe the therapeutic procedures and~     modalities received by patients and the correlation to hormone status, during a one year~     follow up from completion of the 2-79-52030-207 study.~   "
121057|NCT01471392|"~     The overall goal of the present study is to provide evidence of concordant test results~     using the Identigene STD Test Collection Kit for self-collection and transport of specimens~     to a qualified testing laboratory. It is expected that this method will aid in detection of~     CT and NG and that offering a method of self-collection of a male urine or female vaginal~     swab specimen will encourage testing for CT and NG and improve the overall detection of~     reporting of these STDs by allowing persons who suspect they have the infection to be tested~     in a discrete and confidential manner. The reporting of CT and NG are underestimated and~     many subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing~     a self-collection kit that is more convenient may result in improved reporting,~     identification of CT and NG positive individuals, and subsequent treatment to help prevent~     the spread of these diseases.~      The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and~     labeled instructions for use instructions provide test results that are concordant (at least~     95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen~     collection and transport methods performed under the supervision of a healthcare provider.~     The laboratory technology and test method used for the IDTG-100.~   "
121058|NCT01471379|"~     Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for~     treating irritable bowel syndrome (IBS) in women.~      Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS.~      Procedures: This study will observe patients treated with Savella® as well as patients~     treated with a placebo (pill with no active drug). The investigators will monitor and~     compare several patient and symptom related outcomes, as well as evaluate health related~     quality of life, psychological distress and related psychosocial measures to determine if~     the addition of Savella® improves clinical pain response as well as secondary outcomes~     including quality of life.~   "
121059|NCT01471366|"~     Many patients complain of fishy breath, upset stomach, or heartburn when taking the~     recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the~     fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with~     over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken~     daily. The hypothesis of this study is that taking fish oil with milk will help lead to~     better patient compliance with no difference in adverse effects versus other administration~     methods.~   "
121060|NCT01471353|"~     Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal~     cancer may provide clinical benefit when no other treatment remains.~   "
121061|NCT01471340|"~     The purpose of this study is to test the safety of DULERA. DULERA is a pressurized~     metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and~     formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces~     the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which~     helps to relax the muscles of the airways in the lungs, making it easier to breathe. In~     combination, mometasone and formoterol are used for the treatment of asthma. This study will~     evaluate whether participants taking a LABA in combination with an ICS in a single inhaler~     have a different risk of having serious asthma events (hospitalization, intubation and~     death) compared to participants taking an ICS alone.~   "
121062|NCT01471327|"~     SB-240563 is a fully humanized monoclonal antibody which is specific for human interleukin-5~     (IL-5) and has been under development for severe refractory asthma. This study is the first~     study in Japanese subjects. The purpose of this study is to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of single dose SB-240563 administered~     intravenously to Japanese healthy male subjects.~   "
121063|NCT01471314|"~     The purpose of this study is to examine migraineurs during spontaneous migraine attacks~     without aura, using high resolution magnetic resonance imaging (MRI), to study following:~        -  Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using~          functional MRI (fMRI).~        -  Changes in circumferences of intra- and extracranial arteries using MR-angiography~          (MRA).~        -  Changes in regional and global cerebral blood flow (CBF) using the arterial spin~          labeling (ASL) method.~      Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine~     attacks.~      The migraine specific drug sumatriptan will be given to relieve pain and the effect will be~     registered using MRA and fMRI if possible.~   "
121064|NCT01471301|"~     The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus~     erythematosus.~   "
121065|NCT01471288|"~     Carum Carvi has been frequently used in traditional medicine for a variety of disease~     ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients~     with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of~     levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This~     observation led to a pilot study for evaluation of the effect of carum carvi on thyroid~     function.~   "
121066|NCT01471275|"~     With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi~     decoction in treatment of obesity with type 2 diabetes, dyslipidemia~   "
121067|NCT01471262|"~     As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal~     with an emerging aged population, which has a potential higher risk for complication and~     worse long-term outcome. The investigators will be analyzing the liver function and outcome~     after right or extended right hepatectomy in patients over 70 years old.~   "
121068|NCT01471249|"~     This study consists of a prospective clinical trial which aims to evaluate the impact of~     stent insertion for palliation of malignant dysphagia. The main goal being to examine the~     number of days required following stenting in order to have significant improvement in~     dysphagia and the length of time that this baseline is maintained. Approximately 100~     patients will be prospectively enrolled in this study.~      Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal~     esophageal palliative stent insertion will be prospectively enrolled into the study.~     Patients with esophageal obstruction or stricture due to other benign causes, tumors~     obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will~     be excluded from the study.~      The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to~     improve malignant dysphagia as a main factor affecting the quality of life in these~     patients.~   "
121069|NCT01471236|"~     The purpose of this study is to determine the performance of the Agili-C implants. The study~     hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and~     cartilage-bone joint surface defects.~   "
121070|NCT01471223|"~     The purpose of the study is to estimate the incidence rates of Post-transplant~     Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult~     kidney-only transplant recipients treated with Belatacept, and compared the incidences to~     the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time~     of transplantation.~   "
121071|NCT01471210|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and~     immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or~     metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma~   "
121072|NCT01471197|"~     The purpose of this trial is to determine whether Ipilimumab will prolong survival when~     compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.~   "
121073|NCT01471184|"~     The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy~     Eye Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal~     Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS).~      The secondary objectives are :~        -  To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy~          Nasal Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS),~          congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye~          symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic~          rhinometry (AcR).~        -  To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters~          of nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal~          Spray to placebo at each post-treatment visit.~   "
121074|NCT01471171|"~     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a~     day (BID) administered twice a day versus placebo on exercise endurance and on~     hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.~   "
121075|NCT01471158|"~     The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT®~     after a single drop of each medication is administered to both eyes, in patients with~     open-angled glaucoma or ocular hypertension.~   "
121076|NCT01471145|"~     The aim of this project is to study brain functions of 20 heroin addicts (compared to brain~     functions of 20 healthy controls) just before and during a three month extended release~     naltrexone treatment using functional MRI and dopamine transporter SPECT.~      The following hypotheses are tested:~        -  XRNT modulates the fMRI response to drug cues in predetermined brain regions.~        -  The expression of striatal transporters (assessed with SPECT) will decrease after a~          three-month course of extended release naltrexone~   "
121077|NCT01471132|"~     The recurrence and metastasis of peritoneum is always the lethal consequence for gastric~     cancer patients, and there is no effective therapy until now. It has been reported by~     Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called~     hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free~     cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic~     chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study,~     the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety~     and overall survival would be observed and evaluated.~   "
121124|NCT01470508|"~     Promoviendo Alimentacion Saludable (PAS)Promoting Healthy Eating is a research project~     funded by the National Institute of Mental Health. The purpose of this study is to develop~     and test a treatment for eating disorders in Latina adults that is appropriate for their age~     and includes culturally appropriate family intervention.~   "
121078|NCT01471119|"~     To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult~     patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults~     age 18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective~     SCORAD from 10 to 40) are going to be enrolled in a~     randomized,double-blind,placebo-controlled study.Sublingual Dermatophagoides Farinae Drops~     or placebo is given for 9 months in addition to standard therapy.SCORAD,average anesis~     interval,rescue medicine and DLQI will be recorded.~   "
121079|NCT01471106|"~     The goal of this clinical research study is to learn if dasatinib can help prevent breast~     cancer from developing in the unaffected breast.~      Dasatinib is designed to decrease the activity of one or more proteins that are responsible~     for the uncontrolled growth of tumor cells.~   "
121080|NCT01471093|"~     The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in~     healthy subjects.~   "
121081|NCT01471080|"~     In the past, the investigators often treated giant cavernous hemangiomas of the liver by~     hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be~     applied to cure this disease.But we can't get a clear answer about their effectiveness and~     safety. Hence the investigators conduct this study to explore the effectiveness and~     efficiency of the these two methods and compare their short to mid-term outcomes.~   "
121082|NCT01471067|"~     The goal of this clinical research study is to learn if it is safe and feasible to~     transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want~     to learn if this can help to control the disease.~      The cord blood will be changed to make use of sugar that is found in small amounts in blood~     cells. It plays a role in signaling where in the body the transplanted cells should go to.~     Adding more sugars to the cord blood cells in the laboratory is designed to help the cord~     blood cells find their way faster to the bone marrow. This may help your blood counts to~     recover faster. This process is called fucosylation.~      Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to~     the body.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which~     may cause the cancer cells to die. This chemotherapy is also designed to block your body's~     ability to reject the donor's bone marrow cells.~      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer~     cells to die.~      Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from~     growing and spreading in a way that could cause graft versus host disease (GVHD -- a~     condition in which transplanted tissue attacks the recipient's body). This may help to~     prevent GVHD.~      Rituximab is designed to attach to cancer cells, which may cause them to die.~   "
121083|NCT01471054|"~     To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and~     compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema~     after plaque radiotherapy of uveal melanoma.~   "
121084|NCT01471041|"~     The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in~     achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis~     as prescribed.~   "
121085|NCT01471028|"~     The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect~     to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver~     decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E~     providing additional survival data up to a maximum of 5 years that will be included, as~     available, through VTI-208 study termination (after the last surviving enrolled subject~     completes Study Day 91).~      Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91.~      Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function,~     measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP)~     up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days~     28 and 91. Progression is defined as death or the first observed increase of at least 5~     points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at~     least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up~     to both End of Study Days 28 and 91 following Randomization.~   "
121086|NCT01471015|"~     Selective head cooling or whole body hypothermia has become the standard of care for~     neonatal hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major~     neurodevelopmental disability still occurs in nearly 50% of infants ≥ 36 weeks gestational~     age (GA) treated with cooling. No additional therapies have proven to be efficacious in~     further reducing brain injury and impairment for these high risk infants. Neuroprotective~     strategies aimed at improving early childhood outcomes are still needed. An important area~     of study includes therapies that may complement the neuroprotective effects of hypothermia~     and promote neuronal regeneration, recovery and neurovascular remodeling. Among these~     therapies, erythropoiesis stimulating agents (ESA) have been shown to provide~     neuroprotection, improving short and long-term neurologic outcome in brain injury and HIE in~     neonatal and adult animal models. Parallel with neuroprotective effects in experimental~     settings, recent small clinical studies suggest improved outcomes after ESA administration~     in patients with severe traumatic brain injury and HIE. ESA may work through several~     important mechanisms including reduced inflammation, limited oxidative stress, decreased~     apoptosis and white matter injury, as well as via pro-angiogenic and neurogenic properties.~      Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule, has an~     extended circulating half life and comparable biological activity to EPO, including~     activation of the EPO receptor. The proposed study is a Phase I/II dose safety and~     pharmacokinetic trial of early Darbe administered concurrent with hypothermia in human~     newborn infants with moderate to severe birth asphyxia. The long-term objectives of the~     proposed research are to reduce mortality and to decrease the risk of long-term disabilities~     in infants with HIE who survive beyond the newborn period.~   "
121087|NCT01471002|"~     The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of~     renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a~     partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of~     residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6,~     M12).~   "
121088|NCT01470989|"~     This was an 18-month, multi-center, open-label, clinical extension study. Patients~     completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to~     be treated in this combined extension 3 study for any new gouty arthritis flare on demand~     with one subcutaneous (s.c.) injection of canakinumab 150 mg.~   "
121089|NCT01470976|"~     The primary aim of the study is to investigate whether a goal-directed resuscitation therapy~     in high-risk patients through cardiac index optimization using the LiDCO Rapid device~     reduces complications after cardiac surgery. The hypothesis is that there are better~     outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an~     arterial lactate higher than 1.5 mmol/L.~   "
121090|NCT01470963|"~     The purpose of this study is to examine whether the implementation of a referral template~     will increase quality of health care delivered and the quality of health care co-operation.~     The investigators intent to implement a referral template, at the level of the general~     practitioner (GP), for the referral of patients within 4 separate diagnostic groups:~        -  dyspepsia/upper GI symptoms~        -  colonic cancer investigation/lower GI symptoms~        -  chronic obstructive pulmonary disease (COPD)~        -  chest pain~      Local GP clinics will be randomised to use the referral template or to use standard referral~     practice. Using a predefined set of quality criteria the investigators will score the~     process of care in each patient, and compare intervention and control groups. In addition~     other criteria will be collected and compared between the two groups, e.g.~        -  time to diagnosis/treatment~        -  quality of referral~        -  more appropriate referrals~        -  patient satisfaction (as measured by a questionnaire)~      The investigators hypothesize that the implementation of a referral template will lead to a~     measurable increase in the quality of health care delivered.~   "
121091|NCT01470950|"~     Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase~     activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR~     pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators~     team and others have demonstrated the implication of these signalling pathways in the~     control of muscle mass in humans. However no study has yet investigated the involvement of~     these systems in the early stages of spinal cord injury induced human skeletal muscle~     atrophy.~      The investigators propose to investigate the level of expression of the different components~     of the ubiquitin-proteasome system together with the level of expression and activity of the~     Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months~     following the injury.~      A second aim of this project is to assess if a novel apparatus of electrical stimulation~     which generate movements by closed-loop electrical muscle stimulation may improve strength~     and muscle mass in these patients.~      The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion~     and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a~     first group of patients will undergo a conventional treatment of rehabilitation while a~     second set of patients will be treated using a brand new system of electro-stimulation~     called MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two~     other biopsies will be taken respectively 3 and 6 months post-lesion.~      Our results will provide an increased understanding of the molecular mechanisms contributing~     to skeletal muscle atrophy during the early stages following SCI and a characterization of~     the impact of endurance training in the no more voluntary innervated muscle. Moreover this~     study will also investigate the potential improvement in the rehabilitation process by using~     a new system of electro-stimulation.~   "
121092|NCT01470937|"~     This is an evaluation of the effect of acarbose to delay worsening of fasting glucose~     control in early Type 2 diabetes mellitus.~   "
121093|NCT01470924|"~     A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued.~     The aim of this population-based study was to assess the results of reinduction treatment~     and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden~     2003-2007.~   "
121094|NCT01470911|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need~     for novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product~     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA~     (deoxyribonucleic acid) zymes (antisense oligonucleotide). DNAzymes are catalytically active~     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3~     mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic~     airway inflammation.~      DNAzymes are completely generated by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or~     bacteria. The molecules are highly water-soluble and will be applied as solution directly in~     their synthesized form.~      The current study will evaluate the safety and tolerability of increasing single doses of~     inhaled SB010 in healthy male subjects.~   "
121095|NCT01470898|"~     Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness.~     Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably~     help to shorten recovery time and reduce drug consumption. The aim of the study was to~     investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative~     anesthesia consumption.~   "
121096|NCT01470885|"~     Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a~     systemic inflammatory response syndrome with significant morbidity and mortality in 20% of~     patients. Part of endocrine function of pancreas would be affected in AP. Stress~     hyperglycemia would explode at acute phase. So the investigators decide to follow up and~     observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood~     amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to~     identify the die cutting between blood glucose level and acute pancreatitis, and makes~     analysis of the diagnostic value.~   "
121097|NCT01470859|"~     Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the~     first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous~     clinical trial indicated that initial pramipexole owns advantage over levodopa regarding~     motor complications, on the contrary, less adverse effect like freezing and severe~     somnolence favors initial treatment of levodopa. Thus, it remains controversial that~     initiation of which medication will be better for those patients with early PD.~      Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can~     represent the network activity of brain and severity of PD. Based on the literatures and our~     previous data, the investigators hypothesize that PDRP will be served as a biomarker to help~     us evaluate and compare the effect of levodopa or pramipexole on the progression of PD,~     which might be able to provide further evidence for clinicians to address the above critical~     issue.~   "
121098|NCT01470846|"~     Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and~     postoperative respiratory complications together with quicker recovery of bowel function.~     Currently, no studies have been able to prove its ability to reduce length of stay in~     intensive care and high-dependency units.~      Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length~     of stay in intensive care unit after abdominal surgery under laparotomy.~   "
121125|NCT01470495|"~     RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a~     promising drug to treat late stage HCC. But few studies were related with its effectiveness~     on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might~     reduce the frequency of recurrence and improve the overall survival and disease free~     survial.~   "
121099|NCT01470833|"~     Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great~     social benefits in optimizing treatment and shortening recovery.~      There is no consensus concerning the best treatment of acute achilles tendon rupture.~     Traditionally, surgical treatment is considered superior, but more recent studies show~     evidence that non-operative treatment with early dynamic rehabilitation gives the same~     functional outcome with fewer side effects.~      Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not~     evidence based rather due to tradition. It is well documented that mechanical load improves~     tendon healing in general and has no detrimental effect on the healing of operated achilles~     tendons.~      The objective of this randomized study is to compare early weight-bearing with~     non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.~   "
121100|NCT01470820|"~     Background: Using light emitting diodes (LED's) during conventional phototherapy it is~     possible to reduce the distance from light source to infant, thereby increasing light~     irradiance.~      Objective: To examine the relation between light irradiance and the rate of decrease in~     total serum bilirubin concentration (TsB) and to see if the investigators can identify a~     saturation point, i.e. an irradiation level above which there is no further decrease in~     TsB.~      Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric~     Department, Aalborg Hospital, Aarhus University Hospital, Denmark.~      Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated~     hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device~     to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of~     phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB~     expressed in percent (∆ TsB0-24 (%)).~   "
121101|NCT01470807|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
121102|NCT01470794|"~     This is a multicenter study evaluating the safety and tolerability of increasing doses of~     Toca 511, a retroviral replicating vector, injected into the resection cavity of subjects~     with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their~     tumor. Approximately 6 weeks after injection of Toca 511, subjects will take an oral course~     of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during~     the 31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either~     of the following standard treatments for glioma: lomustine, a drug approved by the FDA to~     treat brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain~     tumors. After completion of this study, all subjects will be eligible for enrollment and~     encouraged to be in a long-term continuation protocol that enables additional Toca FC~     treatment cycles to be given, as well as permits the collection of long-term safety and~     survival data.~   "
121103|NCT01470781|"~     The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based~     cognitive remediation treatment program in patients with bipolar disorder and its effects on~     cognitive deficits and community functioning compared to an active, computer-based control.~   "
121104|NCT01470768|"~     This clinical trial will compare the amount of fatty acids in whole blood of babies fed one~     of two study formulas for 4 months.~   "
121105|NCT01470755|"~     In older children and adults, bronchodilator (BD) dose-effect relationship is part of the~     characteristics of asthma disease. There are no data on BD dose-response relationship in~     wheezy preschool children whose disease pathophysiology is poorly understood, but may, in~     part, takes on the characteristics of asthma.~      The investigators assume that 1) in young children interrupter resistance (Rint) could be~     used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the~     dose-response relationship could depend on the environment and gene polymorphism ADBR2.~      This is a prospective phase II study on dose-response relationship and description of the~     dose-response curve design using a sparse and a modeling approach MCP-Mod.~      The dose-response relationship will be modeled by sparse data. The investigators will test~     two doses per child in four designs that will be drawn. These doses will be assessed using~     Rint technique by a person blinded to the actual dose delivered to the child.~      Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with~     an accuracy of 3.5%, 8.9% and 25.7% respectively.~      The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for~     inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA~     (No. 344 387-3)~   "
121106|NCT01470742|"~     The objective of the trial is to compare Overall survival between capecitabine plus~     oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with~     advanced gastric cancer.~   "
121107|NCT01470729|"~     Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that~     are clinically and genetically various. BIOSCA study aims to identify markers of the~     metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and~     7 patients and control subjects, in the perspective of future therapeutic trials.~   "
121108|NCT01470716|"~     This study examines preoperative Erlotinib in patients with operable stage II and IIIA~     Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.~   "
121109|NCT01470703|"~     This international multicenter, randomized, open trial will evaluate the impact of~     Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute~     respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal~     ventilatory management and maximum medical treatment, on the morbidity and mortality~     associated with this disease.~   "
121110|NCT01470690|"~     The objective of this study is to determine the effect of multiple dose omeprazole on the~     pharmacokinetics of boceprevir and vice versa.~      Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole~     will be evaluated.~   "
121126|NCT01470482|"~     Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby~     improve fixation, it might also cause complications. Migration as measured by~     RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the~     use of a tourniquet influences fixation measured with RSA.~   "
121111|NCT01470677|"~     This is a randomized trial of 140 women with endometrial or cervical cancer undergoing~     removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to~     the pelvic side wall after tissue removal is tested against no such intervention after~     tissue removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic~     lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing~     open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and~     without the application of Tachosil® during surgery. The study's hypothesis is that the~     application of tachosil fibrin patches will significantly reduce the rate of symptomatic~     lymph cysts.~   "
121112|NCT01470664|"~     This randomized, double masked, multi-center study is being conducted to support the safety~     and efficacy of FST-100 for the treatment of acute adenoviral conjunctivitis.~   "
121113|NCT01470651|"~     Fatigue is one of the most common side effects of the treatment of hepatitis C infection~     with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.~     Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and~     shift-work sleep disorder. This is a randomized placebo controlled study to determine~     whether patients assigned to armodafinil have fewer missed doses, dose reductions or~     treatment discontinuation due to side effects in the first 12 weeks of treatment for~     hepatitis C infection than do placebo patients. Placebo patients are offered 14 weeks of~     open label armodafinil after Week 12.~   "
121114|NCT01470638|"~     The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to~     markers for inflammation and degeneration in patients with primary Sjogrens syndrome.~   "
121115|NCT01470625|"~     This is a before-after phase II study, according to the Medical Research Council framework,~     investigating the feasibility of introducing the Liverpool Care Pathway for the dying~     patient (LCP) in 5 Ligurian hospices.~   "
121116|NCT01470612|"~     This study is an open label, long-term extension study for subjects with moderate to severe~     ulcerative colitis designed to evaluate long term therapy of CP-690,550.~   "
121117|NCT01470599|"~     The study hypothesis is to establish the safety and tolerability of long-term open-label~     (OL) CP-690,550 therapy in subjects with Crohn's disease.~   "
121118|NCT01470586|"~     Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups~     for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine~     for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment~     (preoperatively during the intervention and postoperatively) and controls.~   "
121119|NCT01470573|"~     Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to~     corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using~     cell culture technics that could permit the biological replacement of damaged ocular~     surface.~   "
121120|NCT01470560|"~     Many women experience the accidental loss of urine called urge incontinence or overactive~     bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine~     which results in leakage before reaching the toilet. The current usual treatments for urge~     incontinence include behavioral treatment, physical therapy, and medicines. Although these~     treatments have been found to be effective in research studies, they are less effective over~     time in general practice. Because medicines have side effects, many women stop them. The~     purpose of this study is to explore different treatments that may provide another option for~     women with urge incontinence that might be effective. This is an initial study to see if~     these treatments are at least as effective as the usual treatments.~      Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge~     incontinence episodes?~   "
121121|NCT01470547|"~     The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis~     (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections,~     inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is~     responsible for about 20% of all cases. However, data regarding the PVT in cirrhosis are~     insufficient.~      Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can~     occur in approximately 10% of cirrhotic patients.~      Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A~     study in transplant recipients, has documented that in variable etiology cirrhosis, the PVT~     was present in 15.7% of patients, a higher percentage was found in patients with liver~     cancer (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are~     less frequently complicated by PVT.~      The PVT development is due to stagnation in the portal circulation, but alterations in the~     sense of inherited or acquired pro-coagulant may favor its appearance.~      The causal association of PVT with bleeding and bowel infarction suggests that the PVT may~     reduce survival in cirrhosis, but data are lacking on this issue. It is also not known~     whether asymptomatic patients with PVT have a different survival compared to cirrhotic~     patients without PVT. Further studies should be conducted to clarify this issue.~      Likewise, prospective studies are needed to better identify risk factors predisposing to PVT~     in LC patients as well as to clarify the relationship between cirrhosis severity and PVT.~     The impact of PVT on the natural history of cirrhosis is an issue today still debated.~      The PVT not only favour life-threatening complications (gastrointestinal bleeding and~     mesenteric thrombosis) but could also contribute to a deterioration of liver function by~     reducing portal flow. Obtaining such information would be of crucial importance considering~     that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the~     need for randomized controlled trials to clarify the potential effectiveness of~     anticoagulant therapy to improve the survival.~      To this purpose it's proposed to establish an Italian register of patients with cirrhosis.~     In the second phase of the project is planned a 2-years follow-up program in order to assess~     whether the PVT be an additional risk factor for mortality or deterioration of the natural~     history in patients with cirrhosis.~   "
121122|NCT01470534|"~     Having an operation places an enormous burden on the body, leading to the development of~     inflammation and so called 'insulin resistance'. Insulin resistance means the body is unable~     to respond to important hormones that control use of energy. Recent studies have shown that~     patients who develop 'higher' insulin resistance and inflammation have more serious~     complications and take longer to recover after surgery. The investigators do not know what~     controls the development of insulin resistance and inflammation after surgery. Similarly,~     the investigators do not know why certain patients develop much more insulin resistance and~     inflammation than others, even though they have the same operation.~      The main purpose of the study is to try to find out which patients are prone to developing~     greater 'amounts' of insulin resistance and inflammation. The investigators also want to~     find out whether the investigators can reduce the 'amount' of insulin resistance and~     inflammation in these patients (for example by giving them carbohydrate [sugar-based] drinks~     before surgery - these have been shown to reduce insulin resistance in some patient groups).~      Information from this study should improve the way the investigators prepare patients before~     surgery and this should help to improve patient outcomes following surgery (by reducing~     complications and speeding recovery after major surgery).~   "
121130|NCT01470430|"~     The purpose of this study is to measure systemic levels of vascular endothelial growth~     factor (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with~     retinopathy of prematurity (ROP) following ocular treatment with either intravitreal~     injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to~     determine if serum VEGF levels change after treatment.~   "
121131|NCT01470417|"~     This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable~     and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.~   "
121132|NCT01470404|"~     To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity~     profile.~      To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor~     suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric~     cancer patients treated with adjuvant chemotherapy.~   "
121133|NCT01470391|"~     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus~     the Femoral Nerve Block on muscle strength, pain and mobilization after total knee~     arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain~     and morphine consumption as the Femoral Nerve Block, but without the same reduction in~     quadriceps muscle strength.~   "
121134|NCT01470378|"~     This study will investigate the subcutaneous tissue changes in the lymphedema found after~     thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging~     verifying the effects of postoperative lymphatic drainage.~   "
121135|NCT01470365|"~     This phase I trial studies the side effects and best dose of 3-dimensional conformal~     radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients~     with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells.~     Palliative radiation therapy may help patients with recurrent tumors live more comfortably.~   "
121136|NCT01470352|"~     To delineate brain mechanisms that subserve EA in the healthy state and to identify~     alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance.~     Individuals with migraine will be examined between episodes in order to assess basal~     alterations in the efficiency of spatial and temporal filtering of noxious information. This~     population provides the unique opportunity to examine such processes without confounds~     arising from ongoing pain.~   "
121137|NCT01470339|"~     -  To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy~          state.~        -  To identify alterations in mechanisms supporting EA in chronic pain (migraine) and~          their therapeutic relevance.~   "
121138|NCT01470326|"~     In this survey, to collect the safety and efficacy information of Bazedoxifene in daily~     medical practice will be examined. In addition, the necessity of special Investigation and~     post-marketing clinical studies will be examined, while investigating unexpected adverse~     drug reactions during the survey period and understanding of the status of frequency of~     adverse drug reactions in daily medical practice.~   "
121139|NCT01470313|"~     This study is designed to evaluate the safety and tolerability of multiple intravenously~     administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in~     disease activity will also be evaluated.~   "
121140|NCT01470300|"~     The purpose of this research is to investigate how using different methods to reduce the~     energy density of entrees affects daily energy intake in adults. It is hypothesized that~     reducing the energy density of entrees will decrease energy intake. It is also hypothesized~     that reducing the energy density by incorporating fruit and vegetables will decrease energy~     intake more than reducing the energy density by decreasing fat content or adding plain~     water.~   "
121141|NCT01470287|"~     This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent~     vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.~   "
121142|NCT01470274|"~     The primary objective is to establish the safety of the CO-rebreathing method for measuring~     total blood and plasma volume in CAD patients. The working hypothesis is that the~     CO-rebreathing method is safe in use with coronary artery disease patients and that it does~     not cause myocardial ischemia or cardiovascular damage.~   "
121143|NCT01470261|"~     The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate~     (trade name ritalin) on growth, neurological system, psychiatric states and cardiovascular~     system over a two year period in children and adults.~   "
121144|NCT01470248|"~     The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in~     patients with small cell lung cancer who have failed at least one standard chemotherapy~     regimen as well as patients who are unable to tolerate the standard treatment for their~     cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide~     in this patient group. The study will include up to 36 participants with small cell lung~     cancer.~      The investigators want to find out what effects, good or bad, that the study drug has on~     your cancer. This study will also look at specific biomarkers in your blood and in the tumor~     tissue which may help the investigators to determine if the levels of these biomarkers are~     related to tumor response to treatment.~      Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by~     the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer~     called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more~     mature thereby stopping them from growing in number and more likely to die off.~   "
121145|NCT01470235|"~     The purpose of this project is to examine whether the risk of developing ovarian cancer is~     increased in Danish women with congenital missing teeth as a result of their failure to~     develop (hypodontia). Should this prove to be the case, these women could be offered regular~     clinical controls and prophylactic removal of their ovaries when menopause enters and the~     ovaries are no longer functional (producing hormones).~      If there is a connection between congenital hypodontia and the development of different~     types of cancer, the investigators will perform a genetic screening in families with~     increased risk of cancer and hypodontia for changes in relevant genes, based on the current~     literature. The investigators hereby search for new genes, which in a changed form leads to~     an increased risk of cancer and thereby enables us to perform genetic screening in risk~     families.~   "
121240|NCT01468974|"~     The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance~     of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease~     of the superficial femoral (SFA) or common or external iliac arteries.~   "
121146|NCT01470222|"~     This study is a randomized controlled pilot of a work site weight control intervention. The~     purpose of the pilot is to obtain preliminary data for future NIH submissions. Four work~     sites were identified through a multistage recruiting process. Work sites were randomized to~     either the intervention group, which will receive the intervention immediately following~     randomization or the control group which will receive a shortened intervention over a~     1-month period, 6 months after the active intervention sites have completed their program.~     The intervention will consist of a variety of activities conducted over a 6 month period,~     that are overseen by a work site-Tufts oversight group, including the following optional~     elements: For overweight and obese individuals, regular support groups for weight loss and~     prevention of weight regain. For all work site employees irrespective of weight, handouts~     and posted informational resources on healthy eating, monthly lunchtime seminars, and food~     sampling to facilitate healthy eating patterns for prevention of weight gain.~      Basic online assessments on health and nutrition will be carried out at baseline (week 0)~     and 24 weeks in all work site employees willing to provide information. More detailed online~     and in-person assessments will be performed throughout the 24-week study period in the~     weight loss support group participants (intervention sites) and individuals intending to~     enroll in the support group (control sites).~   "
121147|NCT01470209|"~     This study will assess the safety of combining two agents (everolimus and BKM120) for the~     treatment of advanced cancer arising from solid organ in patients who are no longer~     benefiting from or unable to withstand standard treatment of these conditions.~   "
121148|NCT01470196|"~     Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within~     the cell, which is responsible for degrading or breaking down a wide variety of proteins.~     Carfilzomib has not been approved by the FDA.~      Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM),~     alone or in combination with other drugs. Combinations with rituximab, dexamethasone and~     proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients.~      In this research study, the investigators are testing the safety and efficacy of Carfilzomib~     when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's~     Macroglobulinemia.~   "
121149|NCT01470183|"~     This is an exploratory study. No formal hypothesis will be tested.~      The objectives of this study are to follow Lupus Nephritis patients over a period of 12~     months to:~        -  Establish the baseline biomarker characteristics of patients~        -  Determine the variability of biomarker measures over time~        -  Correlate biomarkers with disease phenotype~   "
121150|NCT01470170|"~     Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in~     many other conscious sedation procedures. Alf and Pro have the characteristic of rapid~     anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too.~     However, the amount of Alf needed in combination with Pro for induction and the timing of~     administration was no standardized. The investigators designed this study to evaluate the~     optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for~     flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of~     Alf and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.~   "
121151|NCT01470157|"~     Background: Sedation is often needed for young children undergoing minor procedures in the~     emergency department (ED). Oral midazolam is one of the most commonly used regimens for~     children undergoing laceration repair but its sedative efficacy was shown to be suboptimal.~     In a few studies oral ketamine has been used successfully for procedural sedation as well.~     The efficacy of using a combination of oral midazolam and oral ketamine for procedural~     sedation has been studied only for invasive procedures in children with malignancies. No~     randomized controedll studies were performed using this sedative combination in children~     requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine~     to oral midazolam for procedural sedation in children requiring laceration repair compares~     to oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled~     study. Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with~     laceration requiring sedation. Interventions: Eligible patients will be randomly assigned to~     one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus~     oral ketamine group. Both groups will be given the same volume of medications. Midazolam~     will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15~     mg) with oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the~     treatment given. Patient monitoring will be conducted according to the American Academy of~     Pediatrics (APP) and the Israeli health ministry guidelines for monitoring and management of~     pediatric patients during and after sedation for diagnostic and therapeutic procedures. Main~     outcome measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis:~     Descriptive statistics will be used to describe the study population. Data will be analyzed~     using t- tests for continuous data and Fisher exact test for categorical data.~      Key words: sedation, children, ketamine, midazolam, emergency department.~   "
121152|NCT01470144|"~     This is an open-label, nonrandomized extension to study AC-066A301. The study will assess~     safety and tolerability of ACT-385781A while providing a means for continuing treatment~     after ending participation in study AC-066A301.~   "
121153|NCT01470131|"~     The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in~     combination with bortezomib and dexamethasone to placebo in combination with bortezomib and~     dexamethasone in the treatment of patients with relapsing multiple myeloma who have received~     one previous therapy.~   "
121154|NCT01470118|"~     This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to~     artificial tears (placebo) in the prevention of ocular itching associated with allergic~     conjunctivitis.~   "
121155|NCT01470105|"~     The goal of this study is to improve how we estimate survival of people with cancer that has~     spread to their bone. There have been previous attempts to estimate survival of people with~     cancer that spread to the bone, but they have not been accurate. This study will try to~     improve the way we estimate survival in people with cancer that has spread to their bone by~     looking to see if a physician assessment and a patient assessment of the health status can~     be blended to give a better estimate of survival than patients or doctors alone.~   "
121200|NCT01469507|"~     The primary objective of this study is to compare a combination of hyaluronic acid and~     chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee~     osteoarthritis (OA) over 24 weeks when administered in three weekly injections.~      Chondroitin sulfate is one of the components of cartilage. Studies have shown that~     chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The~     benefit of V0220 combination is based on two main physicochemical properties, in line with~     the characteristics of osteoarthritic disease: optimising the rheological behaviour and~     improving the buffering effect on synovial flow (outflow buffering).~   "
121333|NCT01467739|"~     The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for~     tracheal intubation in difficult airways due to cervical immobilization by a cervical~     collar, and compare it to a conventional reusable fiberscope.~   "
121156|NCT01470092|"~     Longitudinal epidemiological studies have shown that many women experience significant~     physical and psychological changes as they approach menopause and for a long time following.~     Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in~     libido are common, and impact significantly on the quality of life, social and personal~     well-being. However, the major reason that many women seek help from menopause clinics or~     their doctors, is for depression and anxiety symptoms. As such, treatment commonly draws on~     traditional approaches for the management of major depression including the use of~     antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or Selective~     Norepinephrine Reuptake Inhibitors (SNRIs) as the first line response. However, standard~     treatment of menopausal depression using antidepressants has only shown small improvements~     at best and at worst, is associated with severe side effects. Some SSRIs have been shown to~     be less effective in postmenopausal women compared to child bearing age women.~      Newer therapies directly targeting the disrupted hormonal systems (in particular estrogen)~     through the administration of such compounds as tibolone, have shown significant potential~     to treat depression with the added benefit of fewer adverse side effects. With growing~     evidence supporting the use of tibolone as a viable and improved treatment for menopausal~     depression, the investigators propose to investigate the potential of tibolone, a selective~     Hormone Replacement Therapy (HRT), to ameliorate de-novo or first onset depression occurring~     in the menopausal period.~   "
121157|NCT01470066|"~     Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography~     (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in~     predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma~     (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been~     determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT~     will be prospectively investigated to determine whether it provided additional prognostic~     information and could be a positive predictable value for the treatment of PTCL.~   "
121158|NCT01470053|"~     The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus~     azelastine HCl in patients with perennial allergic rhinitis.~   "
121159|NCT01470040|"~     Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established~     risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however~     evidence guiding the decision to continue or discontinue LDA in patients who have sustained~     mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess~     whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients~     50 years and older who present with negative head CT. The investigators further aim to use~     the initial findings to refine the study design, with the goal of performing a larger,~     multi-institutional study in the future.~      Over a 12-month period, approximately 100 patients ≥50 years of age on LDA prophylaxis~     presenting to Hadassah's Emergency Department after sustaining mild head injury, will be~     examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at~     clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to~     participate in a randomized study. Informed consent will be obtained. Patients will be~     remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and~     clinical examination will be performed 3-5 weeks after trauma.~      The two-proportions test will be used to assess whether there is a statistically significant~     difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those~     randomized to continuation of LDA. Relationships between the explanatory the dependent~     variables will be explored with classical parametric and nonparametric statistical methods,~     including multivariate analysis, logistic regression, the two proportions test, and the~     independence test. Several measures of association/correlation between pairs of variables~     will be analyzed as well.~      The investigators hypothesize that continuation of LDA will not be associated with increased~     risk for chronic subdural hematoma, and that cessation of treatment will not be associated~     with a decrease in chronic subdural hematoma. The investigators further hypothesize that~     cessation of LDA for this period will not be associated with increased risk for clinically~     significant cerebrovascular, cardiovascular, thrombotic, of embolic event.~   "
121160|NCT01470027|"~     The overall objective of this developmental/exploratory study is to use noninvasive proton~     magnetic resonance spectroscopy (1H MRS) to determine (a) whether levels of the antioxidant~     glutathione (GSH) are decreased in vivo, as has been found in postmortem brain, in the brain~     of 30 patients with Parkinson's disease (PD) compared to matched controls; (b) whether GSH~     levels in PD brain increase significantly following 30 days of daily supplementation with~     1800mg or 3600mg of N-acetylcysteine (NAC) compared to placebo and to baseline, and (c)~     whether any such increases in brain GSH would be dose-dependent and be associated with a~     change in the participants' oxidative stress profiles. In addition, a clinical assessment~     battery, including quantitative tests of motor function, will be performed to investigate~     potential associations between the NAC intervention, brain GSH levels, oxidative stress~     markers, and clinical presentation. If successful, this study will represent the first~     objective documentation of whether there is a GSH deficit in living PD brain that dietary~     NAC supplementation can mitigate, thereby providing a compelling justification for~     investigating such neuroprotective strategies in larger controlled clinical trials.~   "
121161|NCT01470014|"~     The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC)~     have been well established for echocardiography and cardiac magnetic resonance, such~     validation is lacking for computed tomography (CT). Such criteria are of great clinical~     relevance as a growing number of patients undergo a cardiac CT scan in daily clinical~     routine.~      The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC~     from lesser degrees of trabecular layering seen in potential differential diagnoses such as~     cardiomyopathies and left ventricular hypertrophy or dilation.~      The investigators hypothesize that echocardiographic diagnosed pathological trabeculation~     can be distinguished by determining the ratio of non-compacted to compacted myocardium on~     cardiac CT.~   "
121162|NCT01470001|"~     This is a double-blind, randomized, controlled, parallel design (n=140) study with the~     purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post~     Void Dribbling (PVD).~   "
121163|NCT01469988|"~     Evaluate the efficacy and safety of testosterone supplementation on functional capacity,~     biomarkers, quality of life and clinical outcomes for patients with heart failure.~   "
121201|NCT01469494|"~     The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in~     breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt~     to be an improvement as it does not damage the abdominal wall. The SIEA unfortunately has~     smaller vessels which put the flap at a higher risk of developing flap loss and fat~     necrosis. The uncertainty regarding the tradeoffs inherent in the choice of procedure has~     not been resolved. As such the investigators aim to perform a randomized single blinded~     trial to evaluate the abdominal and breast related morbidity associated with DIEP and SIEA~     flaps.~   "
121202|NCT01469481|"~     The purpose of this study is to evaluate the excretion balance, metabolic profile and the~     routes of excretion of [14C]PF-04991532 in healthy adult male subjects.~   "
121164|NCT01469975|"~     Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled~     homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor~     family, is overexpressed in SS and is undetectable in normal human tissues except placenta.~      OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb)~     against FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic~     activity on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y)~     showed significant antitumor activity following a single intravenous injection in mouse~     xenograft model.~      This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin~     and ifosfamide will be divided in 2 parts.~      In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 [111In]), the~     biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as~     radiotracer.~      In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 [90Y]), the safety~     and PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be~     collected.~      This first in Man study should allow defining the optimal recommended dose of~     OTSA101-DTPA-90Y.~      Patients will be followed during 1 year.~   "
121165|NCT01469962|"~     Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France~     (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic~     steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the~     development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has~     been widely used in obese patients to reduce their weight but also to decrease morbidity~     conditions related to obesity. It could be involved in an improvement in liver lesions~     observed in obese patients. To evaluate the severity of liver lesions, the gold standard is~     pathological examination of the liver using percutaneous or surgical biopsies, with a~     scoring called Fibrosis score stage. Alternative less invasive techniques have been~     developed to evaluate liver lesions. These tests are commonly used in clinical hepatology~     and consisted of serum levels determination of fibrosis markers (Fibrotest, Transthyretin).~      The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in~     a population of patients operated on for morbid obesity ( BMI > 40kg/m2 or BMI> 35kg/m2 with~     comorbidity). The primary end point is to evaluate the concordance between Fibrotest and~     transthyretin serum levels. The number of patients has been calculated on the basis of a~     concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that~     represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in~     this study. According to the number of patients operated on in the 3 centres (>150/year),~     the time for recruitment is 12 months. Secondary end points will evaluate in these patients~     the excess weight loss, the improvement in fibrosis liver tests and the correlation with~     improvement in other obesity- related conditions, according to surgical procedures.~   "
121166|NCT01469949|"~     Mental imagery has been used in a variety of pathological instances in support to classical~     therapeutic treatments. The aim of the present study was to observe the effect of internal~     Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain.~     Fifty-five subjects with a history of low back pain were included in two experimental groups~     who used mental imagery and one control group who did not. The results showed the~     effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning~     of lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input.~     The possibility to use effectively mental imagery, as a part of proprioceptive~     rehabilitation process, is the principal outcome of this study.~   "
121167|NCT01469936|"~     Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a~     heightened and painful response to pressure. Fibromyalgia symptoms are not restricted to~     pain, leading to the use of the alternative term fibromyalgia syndrome for the condition.~     Other symptoms include functional gastrointestinal pain and discomfort.~      The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of~     the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic,~     low-grade, intestinal inflammation due to an increased intestinal permeability.~      In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst~     other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability~     and low-grade inflammation, thus improving gastrointestinal quality of life.~   "
121168|NCT01469923|"~     This is a randomised and single-blind, placebo-controlled study to investigate the safety,~     tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of~     AZD2820 to obese but otherwise healthy male subjects.~   "
121169|NCT01469910|"~     The purpose of this study is to assess the safety and pharmacokinetics of single ascending~     doses of Simotinib Hydrochloride in healthy subjects.~   "
121170|NCT01469897|"~     This project seeks to collect data on healthcare utilization and expenditure rates in~     Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with~     disease activity and outcome measures and determine methods by which to reduce the economic~     impact while improving outcomes.~   "
121171|NCT01469884|"~     Compare the viral load of hepatitis c virus in patients converted to certican versus~     patients who are maintained on calcineurin inhibitor.~   "
121172|NCT01469871|"~     The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO~     and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.~   "
121173|NCT01469858|"~     The main objective of the study is to explore and map brain areas involved in sensory~     perception and multisensory integration in patients with central or peripheral neurological~     damage. The investigators hypothesize for example, that a change (compare to healthy~     subjects) in the perceptual maps and body representation could be detected and characterize~     in patients suffering from impairments of peripheral nerve conduction.~   "
121183|NCT01469728|"~     Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in~     patients with malignant recurrent pleural effusion to relieve symptoms and prevent~     recurrence.~      General anesthesia and one lung ventilation is the standard type of anesthesia employed for~     VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously~     ventilating patients is being increasingly employed to perform several cardio-thoracic~     surgery procedures in an attempt of minimize operative risks and facilitate resumption of~     daily-life activity.~      The investigators have reasoned that for a simple and palliative procedure such as talc~     pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might~     be considered a potential cause of morbidity and delayed recovery. The investigators have~     also hypothesized TEA could be considered an optimal type of anesthesia in this setting~     leading to a fast recovery a reduced overall workload in medical care.~      In this single-center randomized study, the investigators have comparatively assessed the~     impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive~     results of VATS talc pleurodesis.~   "
121203|NCT01469468|"~     The study is designed to investigate the effect of repeated dosing of PF-05175157 on the~     pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.~   "
121174|NCT01469845|"~     Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the~     lungs, and then the airways become blocked, leading to difficulties with breathing. It is~     the most common reason why children are admitted to hospital, with 1-3% of all children~     admitted to hospital during their first winter, creating enormous strains on NHS services.~     The majority of those admitted with the condition are under six months of age and the~     associated stress for parents is considerable. After forty years of research the best~     treatment we have is supportive care and oxygen.~      Recent research suggests that salt water, sprayed as a mist so that the children can breathe~     it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis.~     Scientists think that the salt water changes the mucus which blocks the airways so that it~     can be cleared more easily. Three small research studies all suggested that a child's time~     in hospital could be reduced by a quarter by using this treatment. If this was true, it~     would be good for children, their families and the children's wards trying to cope with the~     large numbers admitted with bronchiolitis every year.~      To decide whether this treatment should be used throughout the NHS, we need to run a~     randomised controlled trial of hypertonic saline in a large number of children. The trial~     will tell us if adding saline to usual care reduces distress in both children and parents,~     as well as whether it reduces the length of time they stay in hospital. We will then know if~     the treatment is the best thing for children with bronchiolitis and whether it provides the~     NHS with good value for money.~   "
121175|NCT01469832|"~     The purpose of this study is:~      To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD .~      To evaluate potential efficacy endpoints to be used in future studies RPE cellular therapy.~   "
121176|NCT01469819|"~     The purpose of this study is to determine if lubiprostone may change the rate of movement of~     food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)~     tract is slower due to constipation.~      To be able to measure the time difference in the duration of transit of the FDA approved~     SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure~     to lubiprostone.~      The investigators anticipate to capture the possibility to reduce/eliminate the small~     intestinal bacterial overgrowth in chronically constipated patients after administration of~     study drug- lubiprostone.~   "
121177|NCT01469806|"~     The primary objective of the Registry is to allow for tracking of FDA approved and/or~     cleared knees used in primary, revision, unicompartmental or partial total knee arthroplasty~     (TKA). Second, it is our desire to assist orthopaedic surgeons in obtaining and evaluating~     radiographic and functional outcomes data on their PFJ patients using current published~     guidelines. Third, within this Registry, subsets of data on newer technology are being~     collected for the purpose of future publications. The Patello-Femoral Joint Post Market~     Clinical (PFJ PMCF) study is one such subset.~   "
121178|NCT01469793|"~     This multicenter, open-label, dose-escalating study will assess the safety, tolerability,~     and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or~     platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending~     intravenous doses of DMOT4039A.~   "
121179|NCT01469780|"~     The focus of this secondary data analysis is to determine whether pain due to a combination~     of both cardiac and non cardiac sources operates as a mediator of behavior change, an area~     that has not been previously evaluated.~   "
121180|NCT01469767|"~     The purpose of this study is to assess the efficacy and tolerability of short-term treatment~     with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our~     hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores~     at Day 7 and Day 14 compared to Baseline.~      Secondary objectives include the use of actigraphy monitoring to determine the ability of~     Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that~     subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy~     movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome~     measures include Eczema Area and Severity Index (EASI) score, body surface area involvement,~     Visual Analog Scale for itch, and Subject Global Assessment. The investigators hypothesize~     that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.~     Medication adherence will be determined using objective adherence monitors. The~     investigators also hypothesize that subjects will have improved adherence to a topical~     medication for AD, compared to published sources, if they are only required to use the~     medication for a short and defined duration.~   "
121181|NCT01469754|"~     Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer~     survivors. PTSD is known to cause problems with anxiety, depression, and quality of life.~     Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.~      Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer~     survivors. It is a positive psychological phenomenon that occurs in some people who have~     suffered a traumatic event--the people who are able to note a greater appreciation for~     life, a stronger relationship with their family/friends, or a new found level of~     spirituality are examples of instances of posttraumatic growth.~      Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is~     a study designed to compare the development of PTSD versus the development of Posttraumatic~     Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment.~     The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of~     PTSD symptoms in the survivor.~   "
121182|NCT01469741|"~     Cognitive impairment is common among non-demented individuals with Parkinson disease (PD)~     and is a significant source of disability and reduced quality of life. Unfortunately, there~     are no successful interventions to address these impairments. Prospective memory impairment~     is a particularly functionally- and clinically-relevant problem in PD. The investigator's~     project will determine if a targeted intervention strategy improves PD participants'~     prospective memory. The investigator's goal is to improve PD patients' everyday prospective~     memory so they can successfully perform desired activities and roles.~   "
121241|NCT01468961|"~     This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The~     purpose of the study is to evaluate an internet-based treatment protocol based on cognitive~     behavioral therapeutic principles. Participants are required to have a previous diagnosis of~     fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all~     included participants will be given treatment, i.e. there is no randomization to a~     comparison group.~   "
121184|NCT01469715|"~     The purpose of this study is to assess the accuracy of the Becton Dickenson (BD)~     Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients~     with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high~     (>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood~     sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST~     Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given,~     when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a~     regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that~     measures and displays blood sugar (glucose) levels in the body throughout the day and night.~     The method being used to detect blood sugar in the investigational Glucose Binding~     Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is~     currently in use by commercially available models.~      Some sensors cannot tell the difference between glucose (sugar) and other substances such as~     Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give~     false readings. The GBP CGM is made to only recognize glucose in the body rather than other~     substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators~     expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the~     current devices.~   "
121185|NCT01469702|"~     Bartonella henselae is the etiologic agent of cat scratch disease (CSD). 90% of patients~     present with regional lymphadenitis (typical CSD) while 10% will have disease involving~     other organs, such as neuroretinitis, arthropathy, erythema nodosum, and encephalitis~     (atypical CSD). In most CSD cases resolution occurs in 2 to 3 months although a prolonged~     course often occurs. Data on the efficacy of antibiotic therapy in CSD is limited.~     Azithromycin has been shown to have a small favorable effect in a small comparative study~     and is commonly prescribed for CSD, however its overall effect is not satisfactory.~     Corticosteroids may be effective in the treatment of CSD for the following reasons:~        -  Many experts believe that host response is involved in the pathogenesis of CSD and is~          responsible for the clinical manifestations rather than the direct effect of B.~          henselae. The absence of viable organisms in affected lymph nodes (in the presence of~          positive PCR for B. henselae DNA), and the fact that arthritis, arthralgia and erythema~          nodosum (that are often associated with autoimmune diseases) have been described in~          CSD, support this concept.~        -  Corticosteroids have been anecdotally reported to have been administered to patients~          with CSD, apparently with some success. The purpose of this study is to evaluate the~          efficacy of corticosteroids in addition to azithromycin in CSD. The study hypothesis is~          that corticosteroids will improve out come. Ten patients with typical CSD will be~          treated with a 5-day oral course of prednisone (1 mg/kg up to 60 mg/day) and~          azithromycin (500 mg on day 1 and 250 mg on days 2-5). Patients will be under followed~          up for 3 months. Major outcome measures will include duration of symptoms and signs,~          with particular emphasis on affected lymph node size and duration using a specific~          scoring system (lymphadenitis score, LS). LS will be used to evaluate lymphadenitis at~          each follow-up visit. The time period from baseline LS until 75% and 90% reduction in~          LS in the treatment group will be compared with historical controls. The historical~          control group will be consisted of age, sex, and clinical manifestations-matched CSD~          patients who were treated with azithromycin without corticosteroids.~   "
121186|NCT01469689|"~     Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but~     analysis of the geographic distribution of one webCBT site showed 15-fold variation in use~     across Britain. Such variation is unlikely to be from differences in prevalence. Raising~     awareness of webCBT could benefit many people with depression but it is not clear how~     direct-to-patient promotion online or via the media, compares with GP centred methods. This~     pilot cluster randomised controlled trial will explore the use of online methods to raise~     awareness in preparation for subsequent study comparing different approaches.~      In a pilot cluster randomised trial the investigators will explore the feasibility and~     likely impact of online methods of raising awareness of webCBT, assessing how many people~     with depression respond to geographically restricted Google and local website~     advertisements. The investigators will explore costs of recruitment and define and document~     the best online methods that might subsequently be used in a definitive trial comparing~     online with mass media and GP centred methods for raising awareness. The investigators will~     compare intervention with control areas to estimate impact on registration levels and~     compare rate of completion of webCBT of these 'additional' registrants with other~     registrants. Recommendations will be made for a subsequent trial comparing online with other~     methods.~   "
121187|NCT01469676|"~     To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might~     reduce the inflammatory response and protect the lungs against the acute injury~   "
121188|NCT01469663|"~     This study examines whether depression in people with borderline personality disorder is~     different than depression in people without borderline personality disorder.~      Unlike people who have depression alone (i.e. without borderline personality disorder),~     people with borderline personality disorder have depressions that often do not improve with~     medications. This makes treating depression much more challenging in someone with borderline~     personality disorder than without borderline personality disorder.~      Borderline personality disorderis associated with difficulty in understanding and~     communicating feelings. Impaired emotion processing may reflect dysfunction of an area of~     the brain, the anterior cingulate.~      Depression is associated with changes in anterior cingulate activity. The investigators~     believe that when borderline personality disorder is present with depression, brain activity~     changes in the anterior cingulate will not be the same as in depressed patients without~     borderline personality disorder.~      An electroencephalogram records brain electrical activity. In this study, the investigators~     will measure electroencephalogram indices reflecting anterior cingulate activity.~      HYPOTHESIS: In this study, the investigators predict that when borderline personality is~     present with depression, electroencephalogram indices of anterior cingulate activity will be~     different from when depression is present alone (without borderline personality). This could~     help to explain why people with borderline personality have depressions that are harder to~     treat than depressions in people without borderline personality.~      The investigators also predict that electroencephalogram indices of the anterior cingulate~     will reflect emotional processing ability, as measured by validated questionnaires.~   "
121189|NCT01469650|"~     The specific aims of this study are to determine levels of vitamin D supplementation to~     achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required~     to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the~     Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized,~     controlled trial, infants 23 weeks gestational age or greater will be randomized to two~     different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin~     D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be~     quantified in these infants.~   "
121190|NCT01469637|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
121191|NCT01469624|"~     Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new~     era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in~     serum creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in~     general population and up to 50% in high risk population. High risk patients include those~     with chronic kidney disease (GFR<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart~     failure, anemia and advanced age. Amount and kind of contrast medium and decreased~     circulating blood volume are other important predictors of CIN. 50% of cases of CIN happen~     within 24 hours of contrast injection. Maximum creatinin levels are reached between 48-72~     hours. It usually returns to previous levels in 7-10 days. Suggested mechanisms are renal~     vasoconstriction and tubular injury. N-acetylcysteine and hydration are proved to be~     protective against CIN and theophylline may have a role. In this study, it is hypothesized~     that pentoxifylline, a dimethylxanthine, can also protect renal cells from CIN. It has been~     observed that pentoxifylline improves oxygen delivery to ischemic tissues, diminishes~     oxidative damage to renal tissue and may also scavenge free radicals. Percutaneous coronary~     intervention is assumed a high risk procedure for developing CIN as the amount of contrast~     used in PCI is remarkable. Therefore, the patients undergoing PCI were selected for the~     trial. A prospective randomized trial will be conducted on patients undergoing PCI.~   "
121192|NCT01469611|"~     The purpose of this study is to:~        -  determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of~          JX-594 administered by biweekly intravenous (IV) infusion.~        -  determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by~          biweekly IV infusion.~   "
121193|NCT01469598|"~     Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of~     DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and~     inhibits microtubule depolymerization.~      In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100~     mg/m2 on day 8 with G-CSF support every 3 week.~   "
121194|NCT01469585|"~     The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose~     doxycycline on the irregular bleeding women experience when taking continuous oral~     contraceptive pills. This research is being done because currently, there is no effective~     treatment for this condition. Findings from this study could help to decrease the side~     effects of birth control pills and decrease unplanned pregnancies.~   "
121195|NCT01469572|"~     The purpose of this study is to see the safety and activity of using pasireotide, everolimus~     and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment~     of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or~     radioembolization are considered standard of care regimens in patients with liver lesions~     from neuroendocrine tumors. However, the use of the combination of everolimus and~     radioembolization has not been formally evaluated in the setting of a clinical trial.~     Pasireotide is a medication that is intended to block the hormonal secretions from the~     neuroendocrine tumors.~      This study is divided into two parts. In the first part, the aim of the study is to~     determine the safety of combining everolimus, pasireotide, and radioembolization. For this~     part of the study the investigators will enroll up to 18 patients. After the investigators~     confirm the safety of the combination, they will conduct the second part of the study which~     will focus on evaluating the effectiveness of the combination. For this part of the study~     the investigators intend to enroll a total of 37 patients.~   "
121196|NCT01469559|"~     The aim of this study is to evaluate the safety and tolerability of intranasal insulin in~     people with type 1 diabetes and diabetic peripheral neuropathy and to determine whether~     intranasal insulin is effective in slowing the progression of diabetic neuropathy.~   "
121197|NCT01469546|"~     The purpose of this study is to investigate a new agent Axitinib in the treatment of head~     and neck cancer.~      This is a new drug that is given as a pill twice a day to treat cancer. This is one of the~     new, smart drugs. It binds to a protein on the surface of the cancer cell called VEGFR,~     and this way it slows down the growth of cancer cells and kills them. Head and neck cancer~     cells are known to carry this protein on their surface. Research in animals and in patients~     with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or~     stopping their growth, by this mechanism. It is generally a safe drug that is given by~     mouth. The investigators do not know, however, whether Axitinib is effective in head and~     neck cancer. This research study is being conducted to learn if Axitinib works in head and~     neck cancer, and also to learn to predict who would benefit from it. Four blood draws will~     be done to check special blood tests while the subjects are treated with Axitinib. These~     will be drawn at the same time as your routine labs, and there will not be additional sticks~     needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test~     how the cancer cells are responding to treatment. By testing these blood and tissue samples,~     the researchers will look at special tests (protein molecules) to try to determine what kind~     of head and neck patients would best respond to this drug. This is an open-label study,~     meaning that all subjects are on the active drug and there is no placebo (sugar pill).~   "
121198|NCT01469533|"~     The purpose of this study is to investigate if the application of spinal mechanical~     manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in~     asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or~     systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced~     sEMG activity after spinal mechanical manipulation to better understand the immediate~     effects of mechanical manipulation on low back region.~   "
121199|NCT01469520|"~     The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric~     formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in~     comparison to an innovator product. Establishing the bioequivalence of a newly developed~     age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral~     dispersible tablet or a reconstitutable suspension for children is invaluable for future~     product registration and availability of the products to children, thus filling the void in~     pediatric HIV/AIDS therapy.~   "
121261|NCT01468688|"~     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase~     2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.~   "
121334|NCT01467726|"~     This is a Phase 1, Randomized, Placebo−Controlled, Double−Blind, Study of Safety,~     Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.~   "
121204|NCT01469455|"~     Phase I trial will be conducted in patients suffering local metastatic melanoma with~     relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the~     preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of~     DT01 supports the initiation of a phase I clinical study in this population. The recommended~     starting dose of DT01 for the first injection to human was based on NOAELs and Maximum~     Recommended Starting Dose (MRSD) calculations and by considering both local and systemic~     approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors~     to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during~     dose escalation.~      DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections~     in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg~     oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times~     a week during two weeks; The study will be an open, non-randomised, multicentre, phase I~     dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.~      The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of~     DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the~     anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration~     of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after~     the beginning of the DT01 treatment.~   "
121205|NCT01469442|"~     Aim : Effect of external biliary duct stent after hepatectomy on the occurence of~     postoperative biliary fistula.~      Methods : French prospective multicenter randomized trial. Population study: Adult patients~     who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.~      Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a~     external biliary duct stent. With this hypothesis, the number of patients required to be~     equal to 152 per group for a total of 304 patients.~      Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma,~     biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat~     biliary fistula, during of hospital stay and biliary fistula.~      Follow up: A follow-up of patients 3 months after surgery for all patients. The planned~     total duration of the study is 3 years and 3 months.~   "
121206|NCT01469429|"~     This randomized phase I/II trial studies the side effects and best way to give lyophilized~     black raspberries in preventing oral cancer in high-risk patients previously diagnosed with~     stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to~     keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer.~     Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from~     patients receiving lyophilized black raspberries may help doctors learn more about changes~     that occur in DNA and the effect of lyophilized back raspberries on biomarkers.~   "
121207|NCT01469416|"~     The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport~     of rosuvastatin clinically.~   "
121208|NCT01469403|"~     The purpose of this study is to compare the efficacy in a group of patients who must follow~     the current procedure for treatment of artificial knee, compared with a group of patients~     who must undergo an 8-week weight loss program before surgery. 1 year after surgery the~     investigators will examine whether there are differences between the two groups' quality of~     life and functional capacity.~   "
121209|NCT01469377|"~     An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to~     Antidepressant Therapy (ADT) in patients with Major Depressive Disorder (MDD) who have an~     inadequate response to antidepressant alone. This clinical study will be comparing~     cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an~     inadequate response to ADT in the current episode. The study will consist of approximately 2~     weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1~     week safety follow-up.~   "
121210|NCT01469364|"~     This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI~     can be safely and self-administered in lung transplant recipients with newly diagnosed~     bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect~     on lung function in order to appropriately design and power a larger multicenter randomized~     study.~      The hypothesis is that AZLI is a safe and effective treatment for declining lung function in~     lung transplant recipients with early stage BOS.~   "
121211|NCT01469351|"~     Today Alzheimers disease can not be cured. Animal experiments have shown that the hormone~     GLP-1 can improve memory in Alzheimer-prone mice.~      The investigators hypothesis is that a 6-month treatment with the GLP-1 receptor stimulating~     drug liraglutide will reduce the intracerebral amyloid deposition in the central nervous~     system (CNS) in patients with Alzheimer's disease (AD) and thereby reduce the clinical~     symptoms of the disease.~   "
121212|NCT01469338|"~     This phase II trial studies how well octreotide works in reducing diarrhea in patients~     receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously~     treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several~     hormones in patients receiving chemotherapy for prostate cancer~   "
121213|NCT01469325|"~     Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high~     frequency, for Treatment-Resistant Depression have been shown to have antidepressant~     effects. but doubts remain about the magnitude of previously demonstrated treatment~     effects.The aim of this study is To test whether daily weekday left prefrontal rTMS safely~     and effectively treats Resistant Depression disorder compared to sham controls.~   "
121214|NCT01469312|"~     The objective of this study is to determine whether ingestion of modified pasta products~     (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when~     compared with a traditional pasta.~   "
121239|NCT01468987|"~     The purpose of this study is:~        -  To compare blood sugar control on LY2605541 with insulin glargine after 26 weeks of~          treatment.~        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin~          glargine during 26 weeks of treatment.~        -  To compare the number of participants on LY2605541 reaching blood sugar targets without~          low blood sugar episodes at night to those taking insulin glargine after 26 weeks of~          treatment.~        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin~          glargine after 26 weeks of treatment.~   "
121215|NCT01469299|"~     The primary objectives of this evaluation are: 1) To attempt to refine the current clinical~     understanding of balance 2) To determine if patients with quantifiably balanced knee~     joints exhibit improved clinical outcomes versus patient with residual imbalance, as~     measured by the VERASENSE™ Knee System~      Secondary objectives:~        -  Determine whether a difference in inter-compartment loads and soft tissue tension~          exists between the physicians intra-operative feel compared to the quantifiable data~          measured by the VERASENSE™ Knee System~        -  Determine which ligament releases are performed by the surgeon to improve soft tissue~          balance while utilizing the information from the VERASENSE™ Knee System~        -  Evaluate range of motion, pain, physical function, activity level, and patient~          satisfaction between baseline (pre-operative) and post-operative follow-up as well as~          radiographic success and survivorship of the knee implants~   "
121216|NCT01469286|"~     Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present~     in at least 20% of about 150 million patients with diabetes worldwide and in more than 20%~     of patients with functional dyspepsia that affects about 10%-25% of the general population.~     Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of~     gastroparesis include nausea, vomiting, early satiety and abdominal bloating.~      Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current~     stimulation instead of manual manipulations of the needles. Recent studies in our lab with~     EA or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric~     motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well~     as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the~     TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin~     next to the stimulation electrodes and therefore the patient can resume normal daily~     activity while being treated by TEA. This is not only attractive but also more effective~     since TEA can be performed more often and for longer durations.~      This exploratory project is designed to study the feasibility, efficacy and certain~     mechanisms of the proposed method of wireless TEA in patients with gastroparesis. Firstly~     the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly,~     the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis~     will be investigated in a double-blinded crossover design in patients with diabetic or~     idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of~     gastroparesis with TEA will be investigated.~   "
121217|NCT01469273|"~     This interventional trial shall investigate the efficacy and tolerance of a suspension with~     non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal~     infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli~     bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.~   "
121218|NCT01469260|"~     The purpose of this study is to evaluate pedometer use by overweight women during pregnancy.~     The study will show if a pedometer will help women to limit weight gain during pregnancy. It~     will also show if it there are other benefits such as decreased diabetes, decreased high~     blood pressure, decreased rates of cesarean section, and decreased complications for the~     baby.~   "
121219|NCT01469247|"~     The goal of this clinical research study is to find a safe dose of radiation that can be~     given to patients with brainstem glioma who have already received radiation therapy.~      You will receive photon radiation therapy. This type of radiation is similar to the~     radiation you have already had. Conformal radiotherapy or intensity modulated radiotherapy~     (IMRT) will be used to try to treat the tumor while affecting as little of the surrounding~     normal tissue as possible.~   "
121220|NCT01469234|"~     The purpose of this study is to determine the onset of action of two commercially available~     over-the-counter antihistamines (Loratadine and~      Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo~     sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research~     Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom~     Complex (MSC) score will then receive drug.~   "
121221|NCT01469221|"~     This is an international, multicenter, double-blind, placebo-controlled, randomized study.~     All eligible patients entering the open label phase of the study will receive a single~     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral~     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double~     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive~     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo~     cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic~     evidence of recurrent disease during the study will be treated according to current~     treatment guidelines or local standard of care. Safety and efficacy assessments will be~     performed at 3 month intervals for all randomized patients throughout the study. Patients~     who receive single dose of apaziquone immediately following TURBT and are not eligible for~     randomization will be followed for 3 months by cystoscopic exam and safety assessments.~   "
121222|NCT01469208|"~     The investigators hope to determine if music therapy will have beneficial effects on~     physiologic parameters, behavioral states, and pain scale evaluations in infants with~     gastroschisis defects and if music therapy promotes parental/caregiver relaxation and~     demonstrates to the parent/caregiver that music is an effective tool to calm and soothe~     their infant at risk for chronic gastrointestinal discomfort.~      Babies will be enrolled during the perinatal period, with therapy to begin after surgical~     repair of the gastroschisis defect and when the neonatologist deems the baby stable enough~     for music therapy intervention. Enrolled subjects may receive up to 3 music therapy~     sessions/week and these sessions may continue until discharge. There is no follow up after~     discharge.~      Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:~        1. Pre music therapy behavior state will be assessed using CRIES scale and recorded.~        2. Five minutes of baseline vital signs will be recorded.~        3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and~          lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels~          will be maintained at 65-75dB. Session will stop if infant shows any signs of~          distress/agitation. Vital signs will be collected every 1-4 minutes during music~          session.~        4. After session behavior state using CRIES scale will be recorded.~        5. Family/caregiver will be given a questionnaire to fill out.~        6. 30 min of quiet will start.~        7. At the end of quiet time, behavior state and vital signs will be recorded for the last~          time.~   "
121223|NCT01469195|"~     During fluoroscopic imaging, diagnostic information is carried in the primary beam. These~     high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation~     deviates in all directions from the patient. Despite typical precautions (i.e., hanging a~     lead shield between the patient and the operator), many operators will be exposed to high~     radiation dose (higher than the permitted 50 miliS per year), this long term radiation~     exposure may result in stochastic and deterministic effects. The purpose of this study was~     to test the hypothesis that a non disposable radiation protection drape (that will cover the~     lower part of the patient) could help minimize the radiation scattered from the patient to~     the operator. In a procedure done through the Radial approach, there is a large portion of~     the patients (from the umbilicus and down) that is a source of scatter radiation to the~     operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of~     uniform thickness will be inserted into a sterile nylon bag and will be used during~     fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover~     the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm~     respectively and was shown not to hinder the field of radiation needed for fluoroscopy and~     cineangiography. (The upper border of the lead is under the patient's umbilicus and was~     shown not to interfere with the radiation field needed for angiography or angioplasty).~      The Investigators anticipate that the study will show a significant reduction in radiation~     exposure and hence reduce the radiation hazard to the operator.~   "
121224|NCT01469182|"~     This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in~     participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary~     objective was to compare treatment-emergent adverse events (AEs) for participants treated~     with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.~   "
121225|NCT01469169|"~     This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled~     Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in~     Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of~     longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.~   "
121226|NCT01469156|"~     This Phase I/II study will investigate the safety and tolerability of intravitreally~     administered 0.5mg and 2.0mg Ranibizumab in three monthly doses followed by a 9 month period~     of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects~     with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.~   "
121227|NCT01469143|"~     This trial is conducted in Europe. The purpose of this trial is to compare the~     pharmacokinetic properties (the exposure of the trial drug in the body) of different~     formulations of NN1218.~   "
121228|NCT01469130|"~     In this study, MEK162 will be administered to Japanese patients with advanced solid tumors~     whose disease has progressed despite standard therapy or for whom no standard therapy~     exists. The trial will investigate the safety and tolerability and determine the MTD of~     MEK162 in Japanese patients.~   "
121229|NCT01469117|"~     This is a single center, prospective, non-randomized, uncontrolled, observational study of~     the use of an enteral nutrition product in pediatric patients with developmental~     disabilities.~   "
121230|NCT01469104|"~     The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results~     in a change in blood glucose that is similar to the change observed after 3 days of fasting.~   "
121231|NCT01469091|"~     The purpose of the study is to see whether intensive smoking intervention on the day of~     operation can reduce per- and postoperative complications in patients operated for acute~     ischaemic disease compared to control group with no intervention.~   "
121232|NCT01469078|"~     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000~     (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney~     Disease on Dialysis Therapy (CKD-5D).~   "
121233|NCT01469065|"~     This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2~     diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and~     pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to~     wash off their diabetes medication for 4-6 prior to study drug administration, and they will~     remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of~     dosing, and some follow up tests.~   "
121234|NCT01469052|"~     The purpose of the study was to characterize the safety of investigational agent AG-013736,~     in patients with solid tumors in this First In Human trial.~   "
121235|NCT01469039|"~     The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or~     ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute~     exacerbation.~   "
121236|NCT01469026|"~     The purpose is to elucidate the value of PET/CT applied early in the work-up of patients~     with a metastasising cancer of an unknown primary tumor.~      The management of patients with metastasising cancer of unknown primary often includes~     various and a large number of radiographic studies and invasive procedures, but the occult~     primary tumor is detected in less than 20%.~      Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive~     diagnostic procedures are carried out. The outcome may be higher tumor detection rate and~     quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number~     of the patients will receive treatment aimed at the correct diagnosis. Therefore, a~     prospective cost-effectiveness analysis is warranted.~   "
121237|NCT01469013|"~     This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension),~     placebo-controlled, dose-ranging, parallel-group study of LY3009104 in Japanese participants~     with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. LY3009104~     will be orally administered once a day with background methotrexate (6 to 16 mg/week)~     therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo),~     and for 52 weeks in the single-blind extension period (4 or 8 mg/day).~   "
121238|NCT01469000|"~     The purpose of this study is to compare the combination of pemetrexed and gefitinib versus~     gefitinib alone, in terms of progression-free survival. This study is in participants who~     have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who~     have not had any previous chemotherapy for stage IV disease.~   "
121242|NCT01468948|"~     Background:~      - Essential tremor (ET) is a condition of out-of-control shaking. Several drugs are used to~     treat ET. However, they are often only partly helpful and can have side effects. Many people~     with ET get some relief from drinking alcohol. Octanol, a food additive similar to alcohol,~     can improve tremor in animals and is less likely to make people feel drunk. One form of~     octanol, called 1-octanol, has been shown to improve tremor in some people and had few side~     effects. 1-octanol is converted to octanoic acid, and research suggests that octanoic acid~     itself might suppress ET with no significant side effects such as drunkenness. Researchers~     want to see what dose of octanoic acid is most useful in reducing ET.~      Objectives:~      - To test different doses of octanoic acid to treat essential tremor.~      Eligibility:~        -  Individuals at least 21 years of age who have ET that responds to treatment with~          alcohol.~        -  Participants must be able to stop taking certain ET medications during the study.~      Design:~        -  This study requires three visits. Visit 1 is a screening visit that will take up to 5~          hours. Visit 2 is a 2- to 3-day inpatient admission to the National Institutes of~          Health Clinical Center. Visit 3 is a followup outpatient visit 1 to 2 weeks after the~          hospital admission.~        -  At the screening visit, participants will have a physical exam, neurological exam, and~          medical history. Blood and urine samples will be collected. Participants will also have~          an alcohol dose test to measure the tremor s response to alcohol.~        -  For the study visit, participants will enter the hospital for testing. Participants~          will have the study drug and test the tremor's response to it. Frequent blood samples~          will be collected.~        -  One to two weeks after leaving the hospital, participants will have a final followup~          study visit. Blood samples will be collected.~   "
121243|NCT01468935|"~     Background:~      - Some transplant recipients have been found to have cells in their uterus that come from~     the donor. Researchers want to study uterine tissue from three different groups of women:~     (1) healthy volunteers, (2) people who have had a stem cell transplant, and (3) people with~     rare diseases or conditions that affect reproduction. These samples will help researchers~     learn more about the way stem cells work in the reproductive tract.~      Objectives:~      - To collect cells from the uterus to study how stem cells work in the reproductive tract.~      Eligibility:~      - Women at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will have an endometrial biopsy to collect cells for study. The biopsy~          visit will take 1 to 2 hours.~   "
121244|NCT01468922|"~     Background:~      - Pazopanib is an anticancer drug that blocks the growth of new blood vessels in tumors. It~     has been approved to treat renal cell cancer. ARQ 197 is an experimental drug that blocks a~     protein called c-MET, which cancer cells need to grow. Studies suggest that some drugs that~     block blood vessel growth can increase the production of c-MET in tumors, which helps cancer~     cells keep growing. Blocking both blood vessel growth and c-MET with pazopanib and ARQ 197~     may help kill cancer cells faster. This study will use these drugs to treat solid tumors~     that have not responded to earlier treatments.~      Objectives:~      - To test the safety and effectiveness of pazopanib and ARQ 197 for advanced solid tumors.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors that have not~     responded to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, and imaging studies.~        -  The study drugs will be given in 4-week cycles of treatment. Participants will take~          pazopanib once a day and ARQ 197 twice a day by mouth. Some participants will start~          with pazopanib or ARQ 197 alone for the first week. Then they will take both drugs~          together for the rest of the study.~        -  Participants will be monitored with frequent blood tests and imaging studies. Optional~          tumor samples may be collected during different treatment cycles....~   "
121245|NCT01468909|"~     This randomized phase II trial studies how well paclitaxel when given together with or~     without pazopanib hydrochloride works in treating patients with ovarian epithelial,~     fallopian tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used~     in chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow~     to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known~     whether paclitaxel is more effective when given with or without pazopanib hydrochloride in~     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.~   "
121246|NCT01468896|"~     This phase I/II trial studies the side effects and best dose of recombinant interleukin-12~     when given together with cetuximab and to see how well they work in treating patients with~     squamous cell carcinoma of the head and neck that has come back, spread to another place in~     the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the~     white blood cells to kill tumor cells. Monoclonal antibodies, such as cetuximab, may~     interfere with the ability of tumor cells to grow and spread. Giving recombinant~     interleukin-12 together with cetuximab may kill more tumor cells.~   "
121247|NCT01468883|"~     Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to~     receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or~     (2) excisional biopsy, axillary dissection, and definitive irradiation.~      Data from single institutions and from retrospective comparisons suggest that definitive~     irradiation with cosmetically acceptable breast preservation offers survival and local~     control results equivalent to extirpative surgery. This study will test this hypothesis in a~     prospective, randomized manner. After primary therapy, subjects will be followed for: (1)~     survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and~     (5) cosmesis.~   "
121275|NCT01468506|"~     The purpose of this study is to analyze and identify pre-, intra-, and post- operative~     parameters that predict Steal-Syndrome with distal malperfusion after Arterio-Venous~     Fistulas (AVF) as primary endpoint. Secondary endpoints are pre-, intra-, and post-~     operative parameters that predict patency and fistula maturation.~   "
121276|NCT01468493|"~     The purpose of this study is to determine whether the improved responsiveness to treatment~     achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be~     explained by CsA's inhibitory action on the circulating suPAR expression.~   "
121277|NCT01468480|"~     Application of four different pulp capping methods on human sound premolars after~     intentional exposure of the buccal pulp horn through a class one occlusal cavity.~   "
121278|NCT01468467|"~     The purpose of this study is to define a safe dose of AC220 when given as maintenance~     therapy after treatment with an allogeneic stem cell transplant.~   "
121292|NCT01468285|"~     Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This~     placebo-controlled pharmacodynamic treatment study will primarily explore the effect of~     betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a~     patient population with MRI evidence of cerebrovascular compromise. Also it will be measured~     if CBF changes correlate with gait and cognitive changes.~   "
121248|NCT01468857|"~     Background:~      - Stem cell transplants are a complex treatment that can have serious side effects. Having a~     caregiver to help with the recovery is critical. Serving in this role, however, can cause~     high stress levels and negative health effects. Researchers want to better understand the~     health effects of caring for a family member or friend after a stem cell transplant.~     Understanding these effects can help develop programs that support caregivers coping with~     the demands of post-transplant care.~      Objectives:~      - To study the physical and emotional health of caregivers for a family member or friend who~     has had a stem cell transplant.~      Eligibility:~        -  Individuals at least 18 years of age who are planning to be a caregiver for a person~          having a stem cell transplant.~        -  Healthy non-caregiver volunteers for comparison studies.~      Design:~        -  A caregiver will be caring for a transplant recipient just before transplant admission~          and up through 6 weeks after hospital discharge. The caregiver will usually live with~          or spend at least 6 hours each day with the recipient.~        -  All participants will have three study visits. The first visit will happen before the~          transplant. The second and third visits will happen at the recipient s discharge, and 6~          weeks after discharge. The following tests will be done at each visit:~        -  A health assessment with a physical exam and review of life events and current health~          problems~        -  Blood, hair, and saliva samples~        -  Questionnaires about stress levels, personal health, and the caregiving process.~        -  Caregiver participants may have an optional fourth study visit within 72 hours after an~          ICU admission. This visit will include the same tests as the other visits.~   "
121249|NCT01468844|"~     Background:~      - Central retinal vein occlusion (CRVO) is a blockage of the main vein that carries blood~     away from the retina in the back of the eye. It can lead to macular edema, a swelling of the~     retina that is a common source of vision loss. Studies suggest that inflammation might be a~     cause. Minocycline is a drug that might help prevent cells involved in inflammation from~     becoming activated. It is approved for use as an antibiotic, but it has not yet been tested~     to see if it can treat CRVO.~      Objectives:~      - To test the safety and effectiveness of minocycline as a treatment for central retinal~     vein occlusion.~      Eligibility:~      - Individuals at least 18 years of age who have central retinal vein occlusion in at least~     one eye, with vision between 20/32 and 20/200.~      Design:~        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect~          themselves from sunlight or artificial ultraviolet rays while in this study.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and an eye exam. One eye will be selected as the study eye to receive~          the medicine.~        -  Participants will take minocycline or a placebo pill twice a day, about 12 hours apart,~          for 2 years.~        -  Participants will have monthly visits for blood tests and full eye exams to study the~          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.~          Those in the study may also receive injections of a drug to prevent the growth of new~          blood vessels in the eye....~   "
121250|NCT01468831|"~     Background:~      - Branch retinal vein occlusion (BRVO) is a blockage of the small veins that carry blood~     away from the retina in the back of the eye. It often leads to macular edema, a swelling of~     the retina that is a common source of vision loss. Studies suggest that inflammation might~     be a cause. Minocycline is a drug that might help prevent cells involved in inflammation~     from becoming activated. It is approved for use as an antibiotic, but it has not yet been~     tested to see if it can treat BRVO.~      Objectives:~      - To test the safety and effectiveness of minocycline as a treatment for branch retinal vein~     occlusion.~      Eligibility:~      - Individuals at least 18 years of age who have branch retinal vein occlusion in at least~     one eye, with vision between 20/32 and 20/200.~      Design:~        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect~          themselves from sunlight or artificial ultraviolet rays while in this study.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and an eye exam. One eye will be selected as the study eye to receive~          the medicine.~        -  Those in the study will take minocycline or a placebo pill twice a day, about 12 hours~          apart, for 2 years.~        -  Participants will have monthly visits for blood tests and full eye exams to study the~          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.~          Those in the study may also receive injections of a drug to prevent the growth of new~          blood vessels in the eye.~   "
121251|NCT01468818|"~     Background:~        -  The National Cancer Institute (NCI) Surgery Branch has developed an experimental~          therapy that involves taking white blood cells from patients' tumors, growing them in~          the laboratory in large numbers, and then giving the cells back to the patient with~          aldesleukin (IL-2) a drug that keeps the white blood cells active. These cells are~          called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment~          to over 200 patients with melanoma.~        -  This study will use chemotherapy to prepare the immune system before this white blood~          cell treatment. Our prior studies indicate that aldesleukin may not be required for~          cell transfer.~      Objectives:~      - To see if chemotherapy and white blood cell therapy without aldesleukin is a safe and~     effective treatment for metastatic melanoma.~      Eligibility:~      - Individuals at least 18 years of age and less than or equal to 70 years of age with~     metastatic melanoma.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institute of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed.~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up~          to 2 days.~   "
121279|NCT01468454|"~     Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these~     children may require surgery to remove part or all of their pancreas. In this study,~     researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine~     (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by~     surgery. Eligible participants in this study will have positron emission~     tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.~   "
121280|NCT01468441|"~     The present prospective study was designed to compare the effects of administering a daily~     dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of~     GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients~     stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic~     gonadotrophin (hCG) microdose.~   "
121252|NCT01468805|"~     Background:~      - Cockroach allergies are an important risk factor for asthma in inner-city households,~     especially in children. A new method for killing cockroaches may help children who live in~     households that have high numbers of cockroaches. Because most public health treatments~     target more than just cockroaches, this method could lower the costs of treating childhood~     allergies and asthma by focusing on the most likely source of the allergy.~      Objectives:~      - To test a new cockroach-killing method designed to reduce asthma in children exposed to~     cockroaches.~      Eligibility:~        -  Children 5 to 14 years of age who have moderate to severe asthma.~        -  Children must live in a household that has a high number of cockroaches.~      Design:~        -  Participants will be screened with a phone call and an initial home visit.~        -  Study doctors will place cockroach traps, and return after 3 days to check the number~          of roaches caught and killed. Dust samples will be collected from the house.~        -  Participants will have blood and lung function tests, and will be tested for allergies~          (including cockroach allergies).~        -  Some households will be treated for cockroaches at regular intervals, or more~          frequently if required by the study doctors.~        -  Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and~          12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma~          symptoms. The home visits will also check the cockroach levels in the house.~   "
121253|NCT01468792|"~     The study serves the identification of early forms of pulmonary arterial hypertension (PAH)~     in connective tissue disease and the hemodynamic follow-up of the investigated patients. The~     basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which~     leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus~     a disproportional increase in pulmonary pressure during exercise. Recent studies have shown~     that a proportion of such patients may develop manifest PAH within a few years. The early~     identification of these patients and the understanding of the natural course of the disease~     may improve prognosis. The aim of the present study is to investigate hemodynamic and~     clinical changes in patients with connective tissue disease in a time interval of 3-5 years~     with a focus on the development of pulmonary hypertension.~   "
121254|NCT01468779|"~     The purpose of this study is to evaluate the effect of the probiotic use in patients with~     periampullary cancers undergone curative or palliative treatment considering nutritional~     status, postoperative complications, infection rate, length of hospitalization and~     mortality.~   "
121255|NCT01468766|"~     The purpose of this randomized intervention study is to investigate the effects and~     biological mechanisms of a supervised 12-week progressive resistance training on fatigue and~     immunological and inflammatory biomarkers in breast cancer patients during adjuvant~     radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial~     effects due to attention by trainers or the group support, patients in the control group~     have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with~     relaxation training (Jacobsen method).~   "
121256|NCT01468753|"~     To evaluate the acceptability, feasibility, and efficacy of vaginal insemination as a method~     of conception in HIV discordant couples (female positive, male negative) desiring pregnancy~     in Kisumu, Kenya~   "
121257|NCT01468740|"~     Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial~     was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL~     as established in HIV-negative patients with HL.~      Treatment schedule:~        -  Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin,~          vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation~        -  Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin,~          cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4~          cycles of ABVD plus 30 Gy IF radiation~        -  Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts~          with far advanced HIV-infection. After the completion of chemotherapy sites of initial~          bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm~          in diameter receive 30 Gy of irradiation.~        -  Primary outcome measure: tolerability, treatment-related mortality~        -  Secondary outcome measure: complete remission rate, progression-free survival (PFS),~          overall survival (OS).~   "
121258|NCT01468727|"~     Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious~     cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental~     decay). Infants acquire cariogenic bacteria from their mothers early in development via~     saliva. There have been several studies that have demonstrated a significant reduction in~     dental caries associated with consumption of the food additive known as xylitol in children~     and adults. Xylitol is a non-toxic 5 carbon polyol, approved as a food additive by the FDA,~     that tastes like and behaves like sucrose in humans. Xylitol is used as a sugar substitute~     to reduce dental caries as it is not fermentable by the caries causing bacteria. In~     addition, an observed positive beneficial side effect of this sugar substitute is that~     xylitol has been shown to reduce mother to child bacterial transfer when used by the mother.~     It is commonly recommended to wipe infants' teeth and gums with a soft cloth to reduce the~     formation of dental bacterial plaque. Recently wipes have been marketed that contain xylitol~     to provide a safe sweet sensation for the infant during this cleaning procedure. However, no~     study has been conducted that assesses the biological effect of applying xylitol directly to~     the teeth and gums of infants. This study will be conducted to test whether xylitol applied~     by swab directly to the infant's teeth and gums will effectively reduce bacterial transfer~     from mother to child. Children age up to two years old whose mothers have high cariogenic~     bacterial counts will be recruited to use xylitol wipes 3-4 times daily in addition to their~     normal preventive regimen. This will be a randomized double blinded study where the control~     group will receive placebo wipes (with no xylitol) and the experimental group will receive~     the xylitol wipes. The mother-child pair MS and LB bacterial counts and caries score of the~     children will be measured at baseline, 3 months, 6 months and 1 year. We will contact all~     patients that were recruited into the study to inquire whether they are willing to return~     for further follow-up visits at 1, 2, 3, and 4 years post-wipe treatment completion. If~     successful, this study will support the use of a simple caries preventive measure that could~     be easily and safely implemented in young children. Ten MS isolates and unique LB colonies~     will be isolated from each saliva samples to study their genetic diversities and virulence~     factors.~      The investigators will also investigate whether specific MS genes relate to ECC prevention~     effect of daily xylitol-wipe application using genomic sequencing of MS isolated from~     current study when the active intervention was applied.~   "
121259|NCT01468714|"~     This study will evaluate the potential for a drug-drug interaction of PF-04937319 with~     ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.~   "
121260|NCT01468701|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into two~     protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic~     Area) countries, and 1160.136 for EU and EEA countries. The total number of patients~     enrolled in both protocols is estimated to be 48,000 patients, and all these patients will~     be included in the data analysis for study 1160.129.~   "
121262|NCT01468675|"~     Growing evidence and understanding of an inherited component to several common, chronic~     diseases has led to an increase in the importance of information about family health~     history, and the integration of this information with other risk factors for common~     diseases, like lifestyle risk factors. The US Preventive Services Task Force (USPSTF)~     recommends the use of family health history as a routine genetic screening test for common~     diseases, as obtaining a complete family health history is the first step to identifying~     patients who are in need of intervention (e.g., intensive screening, lifestyle modification,~     preventative therapies, genetic counseling). The importance of integrating family health~     history with an individual's medical record will increase as our understanding of the genome~     evolves because it will be more essential to put detailed personal genetic information into~     a clinical context. Because of limited time during a typical primary care visit, and the~     concerns of primary care providers (PCPs) about their self-efficacy of estimating and~     providing guidance about risk, PCPs frequently do not obtain a family health history or~     provide individualized risk assessment. These issues highlight the need to leverage~     technology to collect these data independent of clinic visits, yet have these data~     interoperate with an individual's electronic health record (EHR). Telephonic interactive~     voice response systems (IVRS) and self-administered web-based tools are a low-cost,~     sustainable way of reaching out to primary care populations, independent of a visit. We~     propose to develop, implement, and evaluate a patient-reported, EHR-integrated personalized~     risk assessment module to provide tailored disease risk and risk reduction information.~      The Specific Aims of the proposed project are to: Aim 1: Develop a patient-reported,~     EHR-integrated, personalized risk assessment module to provide tailored disease risk and~     risk reduction information for four common diseases (breast cancer, colorectal cancer,~     coronary heart disease, and type II diabetes) for the patient and his/ her PCP. Aim 2:~     Measure the reach and effectiveness of this integrated risk assessment module by conducting~     a cluster randomized controlled trial (RCT) of adult primary care patients in the Brigham~     and Women's Primary Care Practice-Based Research Network. Aim 3: Evaluate facilitators and~     barriers to the adoption and implementation of this integrated risk assessment module.~      This project will further our understanding of how technology can be used to fill a gap in~     current clinical practice by facilitating the systematic collection of family health history~     and lifestyle risk factor data and integrating these data with an individual's EHR to~     personalize care in a variety of settings and for diverse patient populations. This work~     will use current national data standards for interoperability, and lessons learned from this~     project will be exportable to healthcare settings throughout the United States.~   "
121263|NCT01468662|"~     The investigators propose to conduct a study to measure the reproducibility of CMR~     parameters that have been used to predict outcome following PPCI: infarct size, left~     ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial~     oedema.~   "
121264|NCT01468649|"~     The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph~     node (SLN) identification in patients with breast cancer using near-infrared (NIR)~     fluorescence optical imaging.~   "
121265|NCT01468636|"~     The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on~     genital warts. Our hypothesis is that there will be a 10% difference in complete clearance~     of genital warts in the group randomized to oral plus standard of care compared to those~     randomized to placebo plus standard of care.~   "
121266|NCT01468623|"~     The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU~     versus standard Body Surface Area (BSA) based administration of 5-FU in patients with~     metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to~     determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR)~     relative to BSA dosing response.~   "
121267|NCT01468610|"~     This study will investigate the relationships between subjective cognitive complaints,~     neurocognitive deficits, and work productivity in participants with Major Depressive~     Disorder (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our~     hypothesis is that, in working participants with MDD of at least moderate severity,~     neurocognitive deficits will predict poorer work functioning and productivity.~   "
121268|NCT01468597|"~     The aim of the study is to evaluate if there is an association between platelet inhibition~     and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual~     antiplatelet therapy.~   "
121269|NCT01468584|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and~     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous~     treatment.~   "
121270|NCT01468571|"~     The purpose of this study is to determine the effects of spironolactone on collagen markers~     in a large number of patients with pulmonary hypertension. In addition, safety and~     tolerability of spironolactone, an aldosterone receptor antagonist, in patients with~     pulmonary arterial hypertension, will be determined.~   "
121271|NCT01468558|"~     Compare the DHE pharmacokinetic profiles observed following administration of:~        1. MAP0004 (oral inhalation DHE)~        2. MAP0004 co-administered with oral Ketoconazole~        3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)~      Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of~     Ketoconazole.~   "
121272|NCT01468545|"~     Ventavis it's a treatment for pulmonary hypertension, administered by an inhaler called~     I-Neb.~      In these patients, the non compliance of the treatment becomes its ineffective and increases~     the complications and mortality of the disease.~      It is therefore important to know which the adherence of patients to their treatment is and~     try to promote it.~      One possibility to reach a good level of adherence is the patient education regarding the~     drug administration and also to comply as better is possible the recommendations of the~     physician.~      For this reason, the objective of our study is to demonstrate improvement in the level of~     treatment compliance when they follow a strategy of continuing education, assessed by the~     device and software called Insight.~      The only special procedure to participate in the study then is that patients involved could~     receive more training than usual.~      Investigators expect involving in this study around 50 patients in treatment with Ventavis~     and diagnosed of Pulmonary Arterial Hypertension in 10-12 hospitals throughout Spain.~      The patients who participated in the study will be followed for 12 months from inclusion in~     the study and will perform around 5 visits in total.~   "
121273|NCT01468532|"~     This phase I/II trial studies the side effects and best dose of pasireotide and to see how~     well it works when given together with docetaxel and prednisone in treating patients with~     metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel~     and prednisone, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Pasireotide may inhibit the secretion of~     hormones. Giving pasireotide together with docetaxel and prednisone may kill more tumor~     cells.~   "
121274|NCT01468519|"~     Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with~     diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with~     diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic~     control increases the risk ED. Although comparatively costly, advantages of CSII over other~     modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and~     improved quality of life. In a previously published study, on CSII in T2DM, in our center,~     83% of men reported an improvement in sexual function as a secondary endpoint. The current~     study is planned to further explore this finding.~   "
121281|NCT01468428|"~     In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is~     disrupted in several organs such as airways, sweat glands, pancreas and intestines.~     Gastrointestinal symptoms are frequent but little is known about intestinal motility and~     function. Earlier studies using lactulose/hydrogen breath tests have found altered~     intestinal transit time. The method has several sources of errors and results have been~     questioned. This study is using a new, non invasive method to study intestinal motility~     patterns and transit times, Magnetic Tracking System - 1 (MTS-1).~      The aim is to compare patterns of contractility and transit times in the stomach and small~     intestine in adult CF- patients with healthy controls.~      Methods MTS-1 is performed without radiation and is associated with minimal discomfort for~     subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and~     orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ).~     Frequencies of slow waves as well as number and power of phase III contractions can be~     identified.~      Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked~     to ingest a capsule containing 10 radiopaque markers on six consecutive days up to~     examination. The total number of markers in the entire colorectum is counted. Total transit~     time, as well as segmental is calculated.~      Subjects 15 adult patients (> 18 years) with CF, homozygote for the mutation ΔF508, are~     studied. They are all pancreas insufficient (fecal elastase < 100 µg/g), with no previous~     intestinal resection or lung transplantation. None of them have diabetes. Patients are all~     in well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile~     weight over the last half year. They have had no treatment with antibiotics in the last 14~     days up to the examination.~      The hypothesis is that patterns of contractility and transit times are the same for~     CF-patients in well -regulated PERT as for healthy controls.~   "
121282|NCT01468415|"~     The American Society of Anesthesiologists Task Force on Management, Chronic Pain section,~     recommended Phenol neurolysis when other techniques have failed to provide adequate pain~     control. In this study we sought to Compare the pain relieve on a Lower Back and Limbs~     obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach. The~     study includes patients who suffers from a chronic low back and/or limbs pain which were~     referred to be given epidural as a treatment. Control group receives 80 mg~     Methylprednisolone while the test group receives phenol 8%.~   "
121283|NCT01468402|"~     The purpose of this study is to determine predictive factors in the pelvic magnetic~     resonance in the response of arterial embolization of uterine leiomyoma.~   "
121284|NCT01468389|"~     The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine~     With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer~     is effective and safe.~   "
121285|NCT01468376|"~     The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.~   "
121286|NCT01468363|"~     There is no easily applicable method to determine extra cellular volume and consequently~     estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several~     indirect methods.~      Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available.~     This non-invasive, cheap easily repeatable method has the potential to improve dialysis~     outcome in the majority of patients all over the world, The aim of the present project is to~     assess the feasibility of volume control by using a BİS device.~   "
121287|NCT01468350|"~     A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to~     evaluate the safety and tolerability and the effect of dalfampridine extended release (ER)~     tablets on sensorimotor function~   "
121288|NCT01468337|"~     Background:~      - In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina~     at the back of the eye. CSC can resolve on its own, but in some people it lasts for several~     months or can come back. The fluid buildup during CSC can cause vision loss. The drug~     interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to~     see if interferon gamma-1b can help treat and prevent vision loss from CSC.~      Objectives:~      - To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC.~      Eligibility:~      - Individuals at least 18 years of age who have CSC in at least one eye.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have an eye exam and blood tests.~        -  This study will require at least ten visits to the National Institutes of Health eye~          clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours.~        -  Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8,~          12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve~          blood tests and eye exams.~        -  Participants will receive the study eye drops at the initial visit. The drops must be~          used three or four times a day for 2 weeks. They must be stored in a cool place (like a~          refrigerator). The doses will follow an escalation schedule with the first participant~          receiving 2 drops three times a day and the last participant receiving 4 drops four~          times a day. To maximize safety, the most-recently enrolled participant will complete~          Week 4 before the next participant can enroll (e.g., the second enrolled participant~          will not be enrolled until the first has completed the Week 4 visit).~        -  If the CSC does not improve after the first 2 weeks, participants will receive another~          2 weeks of eye drops. This set of drops will start 4 weeks after the initial study~          visit.~        -  If the CSC does not improve after the 8-week study period, participants may receive~          additional eye drops at the maximum dose of 4 drops four times daily.~        -  The study will end for each participant at one year (48 weeks after the initial study~          visit).~   "
121289|NCT01468324|"~     Background:~      - AZD7451 is a drug that may help interfere with brain tumor cell growth. It can prevent~     glioma cells from entering into normal brain tissue, and slow or stop the growth of~     additional tumors. Researchers want to see if AZD7451 is effective against gliomas that have~     not responded to surgery, radiation, or chemotherapy.~      Objectives:~      - To see if AZD7451 is a safe and effective treatment for gliomas that have not responded to~     standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have gliomas that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a physical exam, medical history, blood and urine~          tests, heart function tests, an eye exam, and imaging studies.~        -  Participants will take AZD7451 daily by mouth for 28-day cycles of treatment.~        -  Participants will keep a medication diary and record any side effects. Treatment will~          be monitored with frequent blood tests and imaging studies.~        -  Treatment will continue as long as there are no serious side effects and the tumor does~          not start growing again....~   "
121290|NCT01468311|"~     Background:~        -  Hodgkin s lymphoma (HL) is a highly treatable cancer. However, if HL does not respond~          to chemotherapy or returns after chemotherapy, further treatments often are not~          successful.~        -  Some HL cells have a molecule called CD25 on the surface. Daclizumab is a drug that can~          detect CD25 on cells. In a treatment study for HL that did not respond to chemotherapy,~          daclizumab plus a radioactive atom called Yttrium 90 helped kill these HL cells.~          Researchers want to combine this 90Y daclizumab with high-dose chemotherapy and stem~          cell transplant. This treatment may be more effective than the daclizumab alone.~      Objectives:~      - To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can~     treat HL that has not responded to earlier treatments.~      Eligibility:~      - Individuals at least 18 years of age who have Hodgkin s lymphoma that has not responded to~     chemotherapy.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will have filgrastim and plerixafor to move stem cells into the blood.~          Stem cells will be collected with apheresis.~        -  Four weeks after stem cells are collected, participants will have the 90Y daclizumab~          and normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first~          treatment.~        -  Most participants will have a second dose of 90Y daclizumab 6 weeks after the first~          dose.~        -  After each daclizumab treatment, participants will have several imaging studies of the~          chest and abdomen. Blood samples will also be collected.~        -  On the day after the last day of chemotherapy, participants will receive the stem cells~          collected earlier. Filgrastim injections will help stimulate stem cell growth....~   "
121291|NCT01468298|"~     The aim of this study was to investigate the changes in posture, flexibility, muscle~     strength, functional capacity, heart rate(HR), peripheral oxygen saturation, systolic blood~     pressure, diastolic blood pressure and intensity of pain in chronic low back pain underwent~     to Isostretching and GPR.~   "
121294|NCT01468259|"~     This study will be an open-label, single-treatment, single-dose, parallel group study to~     evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe~     renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched~     healthy subjects with normal renal function.~      A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater~     than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89~     mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less~     than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR < 15 mL/min/1.73m² and~     requiring hemodialysis) will be selected according to the inclusion and exclusion criteria.~     The medical and laboratory examinations will take place within 28 days before dosing. A~     single dose of 600 mg of droxidopa as an investigational drug will be administered with 240~     mL of water after an overnight fast (minimum 10 hours).~      Blood samples for the measurement of plasma concentrations of droxidopa and metabolites~     including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be~     collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing~     for healthy volunteers and subjects with mild, moderate, and severe renal impairment and~     those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a~     hemodialysis visit.~      During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer~     will be collected at 30-minute intervals during the dialysis period. In addition, the entire~     dialysate will be collected, its volume recorded, and a sample retained for the measurement~     of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and~     protocatechuic acid concentrations.~      Urine samples for the measurement of urinary excretion of droxidopa and metabolites~     including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be~     collected before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12,~     12-24, and 24-36 hours for healthy volunteers and subjects with mild, moderate, and severe~     renal impairment.~      A post-study visit with physical examination and laboratory tests will take place within~     seven (7) days after the last PK blood sampling.~   "
121295|NCT01468246|"~     The investigators are conducting a longitudinal cohort study of young women with breast~     cancer. The investigators identify women age 40 and younger with newly-diagnosed breast~     cancer from academic and community healthcare institutions. After women consent to the~     study, they fill-out surveys and give blood samples, and the investigators collect tissue~     from their breast cancer tumor after it is removed. Women are surveyed every 6 months for~     the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a~     total follow-up of at least 10 years following diagnosis). The study investigates short and~     long-term disease and treatment issues, tumor biology and the relationship to patient~     outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young~     women who are newly-diagnosed with breast cancer.~   "
121296|NCT01468233|"~     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with~     moderate to severe hidradenitis suppurativa (HS).~   "
121297|NCT01468220|"~     The patient numbers with metabolic syndrome and diabetes have doubled in the last decade.~     Data that physical exercise ameliorates the metabolic syndrome are convincing, although the~     mechanisms of the effect in man are not clear. Numerous endocrine or molecular mechanisms~     modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible~     factor-1 (HIF-1) regulation. Thus, relative hypoxia may link physical exercise and~     modification of endogenous metabolism. Medical communities seem ill equipped to address the~     primary issues involved. The investigators have experience with normobaric hypoxia~     chambers and will now test a (physical exercise) training program, using state-of-the-art~     assessments available nowhere else in Germany. The investigators will compare hypoxia~     chamber, to ambient training, to test the notion that specific exercise conditions could~     regulate specific molecular pathways involved in the pathogenesis of the metabolic syndrome.~     Indeed, hypoxia chamber training could be superior to conventional training in terms of~     reducing cardiovascular risk factors or improving fitness. The investigators will test~     overall metabolism-related effects with a metabolic chamber. The investigators will test~     local metabolism with microdialysis during exercise routines, and the investigators will~     perform fat and muscle biopsies to investigate tissue-related effects. The investigators~     include experience from a broad-ranging spectrum. The investigators findings might improve~     understanding mechanisms linking physical exercise and endogenous metabolism. Furthermore,~     they could influence decision-making regarding non-pharmacological interventions.~   "
121298|NCT01468207|"~     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with~     moderate to severe hidradenitis suppurativa (HS).~   "
121299|NCT01468194|"~     In this investigation the researchers explore whether different types of breathing~     procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a~     acute mountain sickness or a high altitude pulmonary edema.~   "
121300|NCT01468181|"~     This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study~     in participants with type 2 diabetes mellitus who have inadequate glycemic control with~     monotherapy of oral antihyperglycemic medication (OAM).~   "
121301|NCT01468168|"~     To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in~     dry-eye disease.~   "
121302|NCT01468155|"~     It is hypothesized that peri-ablation Dabigatran will be a safe and effective method of~     peri-procedural anticoagulation for Atrial Fibrillation (AF) ablation, resulting in a low~     rate of peri-procedural bleeding and thromboembolic complications.~   "
121303|NCT01468142|"~     The purpose of this study is the observation of the course of~        -  the mechanics of the respiratory system~        -  the endexpiratory lung volume~        -  and the inflammatory response in patients undergoing treatment with extracorporeal life~          support (ECLS) due to severe refractory respiratory failure at our department.~   "
121304|NCT01468129|"~     This study will investigate the efficacy of using cell saver during bilater total hip~     arthroplasty~   "
121305|NCT01468116|"~     Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within~     days after surgery and before significant weight loss. The aim of this study is to~     investigate whether changes in mitochondrial function contributes to the early improvement~     of type 2 diabetes after RYGB.~   "
121306|NCT01468103|"~     This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI)~     and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle~     closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up~     for 3 years.~   "
121317|NCT01467960|"~     In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is~     the principle risk factor of Parkinson with the possibility of its development doubling~     every five years after 65. Because of the increase of the social longevity and aging as the~     main risk factor, there are many repercussions on the health system (hospital stays and~     pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's~     disease exerts an extremely negative impact on life's quality of the patient. In fact,~     because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced~     with the consequent development of the depression. Consequently, the early detection and~     treatment of Parkinson's is necessary.~      To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative~     stress-inflammation vicious cycle seems most promising candidate for diagnosis.~   "
121307|NCT01468090|"~     The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562~     adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in~     order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort~     is established after the implementation of biological agents in the treatment of IBD and the~     investigators hypothesis is that a) Severe disease course in IBD can be predicted by~     phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to~     be used as guidance in the selection of treatment strategy and b) Introduction of biological~     treatment changes the course of disease in IBD and reduces the need of surgical procedures.~      Methods: Medical records will be reviewed to register the use of medication, flare ups~     (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior~     will be evaluated. At outpatient visits patients will get a clinical examination, blood and~     faeces will be collected to biobank and patients will be offered an endoscopical~     examination. The Montreal classification, The Harvey & Bradshaw's activity index (CD) and~     the SCAAI score (UC) will be used to describe disease localization, extent, behavior and~     severity. An electronic database will be established in use of processing data.~   "
121308|NCT01468077|"~     This multi-center, randomized, parallel-group, active-controlled, open-label study will~     evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion~     time compared to the normal infusion time. Patients will be randomized to 8 mg/kg~     RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg~     infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.~   "
121309|NCT01468064|"~     The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous~     transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial~     progenitor cells (EPCs) for treatment of patients with ischemic stroke.~   "
121310|NCT01468051|"~     Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled~     and this could improve seroconversion rate of hepatitis B vaccination.~      In this study, the investigators aimed to compare seroconversion rates and immune response~     rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B~     surface antigen (HBsAg) vaccine given to predialysis CKD patients.~   "
121311|NCT01468038|"~     This is a double blind placebo controlled study of one hundred and four subjects which will~     be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone~     and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups.~     Each of the one hundred and four subjects will undergo baseline examination to include a~     sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and~     four subjects will then be randomly placed in one of the four groups.~   "
121312|NCT01468025|"~     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug~     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and~     tolerability of Theramine alone in patients with chronic back pain in comparison to the~     NSAID, Naproxen, and the co-administration of Naproxen with Theramine.~   "
121313|NCT01468012|"~     The proposed study will look at cocaine dependent individuals and will consist of three~     consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy~     will be administered; 2) the 15-21 day inpatient phase (during which participants will start~     study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging~     and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE~     may reverse baseline brain deficits and if this change is associated with clinical~     improvement. Hypothesis is that treatment with LCE, compared to placebo, increases~     abstinence from cocaine over a 12-week trial in combination with behavioral treatment with~     voucher incentives.~   "
121314|NCT01467999|"~     The purpose of this study is to determine whether guanfacine represents a tolerable,~     potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing~     whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving~     as compared to baseline.~   "
121315|NCT01467986|"~     Children, adolescents and young adults with high risk relapsed or treatment refractory~     neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a~     recommended standard salvage therapy is currently not available.~      The multimodal metronomic approach combining molecular targeted drugs (rapamycin and~     dasatinib) with conventional chemotherapy (irinotecan and temozolomide) will be investigated~     in a randomized fashion as new treatment strategy for patients with rNB. The intention is to~     assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB.~      The combination of irinotecan and temozolomide showed activity in the treatment of several~     solid organ tumors, brain tumors and neuroblastoma. In one study rNB patients received a~     median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a~     cumulative dose of 35% lower than in the RIST design. 33% had disease regression with 8% CR~     or PR. A phase II study in rNB also using irinotecan and temozolomide with a substantially~     lower intensity showed a response rate of 15%.~      The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in~     preclinical studies a synergistic effect on cell cycle arrest, apoptosis and sensitization~     for radio- and chemotherapy. It is assumed that this combination of molecular targeted drugs~     with a tolerable conventional chemotherapy consisting of irinotecan and temozolomide can~     substantially improve the outcome of this patient population. A group of 20 rNB patients~     treated with the RIST therapy approach in a compassionate use setting showed an overall~     survival of 55% at a median of 80 weeks with a tolerable adverse event profile.~   "
121316|NCT01467973|"~     The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a~     multinational , multicentre, prospective, observational, hospital-based registry of patients~     with acute heart failure(AHF) with 3 month and one year follow-up.~      Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure~     particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable~     medical practices and heart failure management setup in the Gulf region, AHF patients in the~     Gulf states are expected to have different presentation and receive different management~     than patients in European countries resulting in different outcome. It is also hypothesized~     that there is considerable gap between heart failure management guidelines and clinical~     practices in the Gulf region.~   "
121318|NCT01467947|"~     This is a prospective, international, multi-center, non-randomized, single arm, open-label,~     postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE~     subjects treated intravenously with Berinert. Individual treatment duration per subject is 9~     months, irrespective of the number of treated attacks. All subjects will receive 20 IU~     Berinert/kg body weight per attack.~   "
121319|NCT01467934|"~     In this study, the investigators will prospectively assess fever rates and other associated~     vaccine adverse events in 6-23 month old patients during days 0-7 after administration of~     trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine~     (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine~     (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly.~     The investigators hypothesize that fever rates will be significantly higher during the 0-1~     days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal~     conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered~     non-concomitantly.~   "
121320|NCT01467921|"~     Oxaliplatin is a platinum analogue that has significant antitumor activity with better~     tolerability than cisplatin. The objective of the study is to evaluate the safety and~     activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin~     combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive~     esophageal cancer.~   "
121321|NCT01467908|"~     It has already been demonstrated that mental imagining of the complex motor act, such as~     limb lifting, can evoke the activation of the involved motor centres even if it doesn't~     result in movement due to paresis. Aim of the study: using the navigated brain stimulation~     system create a new diagnostic model for the differential diagnostics between the vegetative~     state and the minimally conscious state. If the investigators could get from patient the~     efferent motor response after a verbal command, his level of conscious should not be defined~     less than the minimally conscious state.~   "
121322|NCT01467882|"~     The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg~     6-month formulation in 44 patients suffering from central precocious puberty. The total~     study duration per patient will be 12 months (48 weeks).~   "
121323|NCT01467869|"~     Following spinal cord injury, most men are infertile and require medical assistance to~     father children. The conditions that contribute to their infertility are erectile~     dysfunction, ejaculatory dysfunction, and semen abnormalities. The Miami Project Male~     Fertility Program is a research study designed to understand and improve impairments to male~     fertility resulting from spinal cord injury.~   "
121324|NCT01467856|"~     Sleep-disordered breathing (SDB) occurs in 2% to 4% of the non-disabled adult population and~     is characterized by periods of complete breathing cessation (apnea) or marked reductions in~     airflow (hypopnea) during sleep. By contrast, the diagnosis of SDB affects as many as 83% of~     persons with tetraplegia within one year of their injury. While some consider daytime~     somnolescence from poor sleep quality a 'tolerable annoyance', SDB can decrease near-term~     physical performance and mental alertness, decay memory and intellectual processing, invoke~     mood disturbances, decrease healthrelated quality of life(HRQoL), and cause vehicular or~     occupational injury. Recurrent sleep arousal is now strongly associated with cardiometabolic~     (CM) component risks including insulin resistance, obesity, inflammatory stress, and~     endothelial dysfunction. Despite considerable advancements in understanding and treating SDB~     - including favored use of positive airway pressure (PAP) - an evidence base sufficient to~     warrant routine evaluation and treatment of SDB and related sleep disorders remains elusive~     for those with spinal cord injury (SCI). To address these knowledge and treatment~     shortcomings the investigators will conduct a hypothesis-driven study with specific aims~     that will: 1) describe by stakeholder survey the clinically-relevant determinants of sleep~     quality in persons with chronic tetraplegia, 2) assess clinical features and co-morbid risks~     associated with SDB in persons with tetraplegia, and 3) determine in persons with~     tetraplegia having SDB whether treatment using PAP reduces health risks and improves HRQoL.~     Hypothesis 1 will be tested using data derived from a website survey.~   "
121325|NCT01467843|"~     Although national expenditures on back pain treatments have increased substantially over the~     past decade, the health and functional status of persons suffering from back pain has~     deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe~     and relatively inexpensive mind-body therapy that has the potential to provide relief to~     some of the millions of Americans who continue to suffer from chronic back pain.~   "
121326|NCT01467830|"~     The purpose of this study is to determine the efficacy of mesh fixation using absorbable~     versus non-absorbable sutures.~   "
121327|NCT01467817|"~     The purpose of this study is to determine how exercise and nutritional guidance and~     supplementation affects your physical fitness, risk for heart disease, your body's ability~     to burn fat, and your opinions about your health.~   "
121328|NCT01467804|"~     This is a randomized, double-blind multi centric clinic study. Both of therapist and patient~     are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for~     major depressive disorder, the score of HAMD-item＞20，＜35；and meet the criteria for TCM~     syndrome of Liver Qi stagnation and Transformation of Stagnant Qi into Fire. Patients are~     randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50~     mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN~     plus placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are~     measured with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are~     assessed at baseline and end of program. Then data will be analyzed with SPSS software to~     determine the efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild~     to moderate major depressive disorder.~   "
121329|NCT01467791|"~     Registry to follow patients with sarcoidosis associated pulmonary hypertension~   "
121330|NCT01467778|"~     This is a Phase I study to assess the safety of three formulations of the dermal implant~     ELAPR.~   "
121331|NCT01467765|"~     In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been~     speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric~     emptying in PEG patients as compared with regular liquid enteral nutrients, resulting in the~     prevention of aspiration pneumonia.~   "
121335|NCT01467713|"~     The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly~     before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in~     adult patients.~   "
121336|NCT01467700|"~     The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily~     (QD), sublingual (SL), in adult participants with acute depressive episodes associated with~     Bipolar I disorder.~   "
121337|NCT01467687|"~     The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil~     extended release capsules.~   "
121338|NCT01467674|"~     The aim of this study was to investigate the impact of glycemic control on clinical~     periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px),~     reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF)~     and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis~     (CP).~   "
121339|NCT01467661|"~     The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308~     and, in the opinion of the Investigator, will continue to benefit from treatment.~   "
121340|NCT01467648|"~     This is prospective and randomized study to assess the pharmacodynamics (t>MIC) of 0.5 g~     every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1~     h infusion.~      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE~     II score, BUN, Cr, Blood culture will be collected.~      Twelve patients will be enrolled in this study. After completion of the doripenem therapy~     for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate~     their bacterial infections.~      Doripenem pharmacokinetic study will be carried out during the doripenem therapy. Blood~     samples (approximately 2 ml) in group  0.5 g of doripenem with 4 h infusion every 8 h~     regimen will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4,~     4.5, 5, 6, 7 and 8 h after 7th dose of doripenem.~      Blood samples (approximately 2 ml) in group  0.5 g of doripenem with 1 h infusion every 8 h~     regimen will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6,~     7 and 8 h after 7th dose of doripenem.~      The doripenem assays by method of Ikeda K et al. (J Chromatogr B, 2008) will be performed.~      Concentration of doripenem in plasma will be simulated in Monte Carlo technique (Computer~     model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment)~     and %CFR (Cumulative Faction Response)~   "
121341|NCT01467635|"~     A prospective diagnostic clinical study randomising patients undergoing endobronchial~     ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and~     hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy~     forceps (EBUS-TBNB).~      The study aims to establish whether the use of EBUS-TBNB can significantly increase the~     diagnostic yield over EBUS-TBNA, without an increase in complication rates.~   "
121342|NCT01467622|"~     The effect of local chest-tube management protocols on the duration of chest-tube therapy~     following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units.~     The primary study objective was the duration of chest tube therapy in postoperative~     patients.~   "
121343|NCT01467609|"~     Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The~     aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate~     patients with ulcerative colitis and reach high consistency to conventional colonoscopy.~   "
121344|NCT01467596|"~     The aim of this study is to determine the minimum effective volume of local anesthetic~     (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective~     US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume~     required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group~     (>65 years) and in middle aged group (<45years) of patients.~   "
121345|NCT01467583|"~     The primary objective of this study is to determine whether a dose-adjusted prophylaxis~     fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours~     (hr) in patients with renal failure achieves peak and trough levels similar to patients with~     normal renal function, and protects patients from developing venous thromboembolism (VTE).~     Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing~     interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min,~     will be safe and effective.~   "
121346|NCT01467570|"~     It is generally recommended that oral rehydration should be used as first-line therapy to~     treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink~     regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended~     treatment.~      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of~     a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by~     ESPGHAN in children with acute gastroenteritis (AGE).~   "
121347|NCT01467557|"~     This study is an observational registry of patients who have recently been prescribed 1•DAY~     ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.~   "
121348|NCT01467544|"~     Tai chi intervention may lead to relaxation and could potentially reduce the risk of~     cardiovascular disease. This project entails a comprehensive and innovative approach for~     understanding, measuring, and potentially reducing cardiovascular risk in women. The goal of~     this area of research is to reduce cardiovascular risk and perhaps reduce illness and death.~   "
121349|NCT01467531|"~     This will be a single-center, two-cohort, three-period study in healthy adult subjects.~     Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14~     evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to~     provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days~     prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14~     days after the last dose of study drug. There will be a washout period between Period 1 and~     Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day~     after the last day in Period 2. The study will be conducted on an out-patient basis except~     for days where serial pharmacokinetic sampling and safety assessments are scheduled.~   "
121454|NCT01466166|"~     The primary purpose of this study is to observe patients being treated with KRYSTEXXA in a~     standard healthcare setting in order to evaluate the frequency and severity of infusion~     reactions, anaphylaxis and immune complex related events. Additionally, serious adverse~     events associated with KRYSTEXXA therapy will be identified.~   "
121350|NCT01467518|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of HIV infection. As HIV-infected subjects may also~     be receiving methadone for opioid dependence, an evaluation of the potential interaction~     between DTG and methadone is warranted. The primary objective of this study is to determine~     whether concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone.~     As a secondary endpoint, the PK of DTG will be compared to historical data. This study will~     be open-label with subjects receiving DTG and stable doses of methadone. The study will be~     conducted at one center in Canada in adult male and female subjects.~   "
121351|NCT01467505|"~     To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and~     ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen~     following liver transplantation.~   "
121352|NCT01467492|"~     The purpose of this study is to evaluate the efficacy and safety of telaprevir in~     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in~     treatment-experienced Black/African American and non-Black/African American participants~     with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response~     with a prior course of interferon-based therapy.~   "
121353|NCT01467479|"~     The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C~     Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a~     (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic~     acid (HCV RNA) 12 weeks after the last planned dose of study drug.~   "
121354|NCT01467466|"~     The purpose of this research study is to compare the effectiveness of intravenous isotonic~     sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with~     oral placebo for the prevention of serious adverse outcomes following angiographic~     procedures in high-risk patients.~   "
121355|NCT01467453|"~     The study objective is to investigate the clinical applicability of continuous IOP~     measurement using TS with radio transmission over 24 hours.~        -  Trial with medical device~   "
121356|NCT01467440|"~     Retrospective analysis of efficacy of selective laser trabeculoplasty in patients under~     treatment with topical prostaglandins compared to patients without topical prostaglandins is~     performed.~      Inclusion criterion are patients with glaucoma or ocular hypertension, who underwent~     treatment with selective laser trabeculoplasty due to insufficient control of intraocular~     pressure during their routine treatment at the University Hospital Zurich / Division of~     Ophthalmology.~   "
121357|NCT01467427|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)~     of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with~     Haemophilia B.~   "
121358|NCT01467414|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250~     (insulin degludec) in Japanese subjects with type 2 diabetes.~   "
121359|NCT01467401|"~     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and~     safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard®~     30) in subjects with type 2 diabetes.~   "
121360|NCT01467388|"~     Retrospective analysis of efficacy of selective laser trabeculoplasty in pseudophakic~     patients compared to phakic patients is performed.~      Inclusion criterion are patients with glaucoma or ocular hypertension who underwent~     treatment with selective laser trabeculoplasty due to insufficient control of intraocular~     pressure during their routine treatment at the University Hospital Zurich / Division of~     Ophthalmology.~   "
121361|NCT01467375|"~     This trial is conducted in Oceania and North America. The aim of this trial is to assess the~     long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes~     who have completed the BIAsp-1234 trial.~   "
121362|NCT01467362|"~     Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local,~     immunological, genetic and environmental factors. Important symptoms of atopic dermatitis~     are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is~     associated with skin barrier dysfunction that facilitates an easier allergen penetration~     into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of~     important stratum corneum intercellular lipids and an inadequate ratio between compounds~     enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy~     usually twice daily improves dryness and subsequently pruritus during the treatment of~     atopic dermatitis and especially improves the barrier function. Emollients make part of~     basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology~     and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier~     alteration, measured by skin hydration, is a key element for evaluation of emollient~     treatment efficacy.~      The primary objective of this study is to demonstrate the efficacy of the tested product~     (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient~     formula during 28 days.~   "
121363|NCT01467349|"~     This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as~     part of an optimized therapy in a clinical setting.~      Follow-up is calculated from the treatment initiation (with or without raltegravir) up to~     the date of discontinuation of the considered regimen or the date of last visit or the date~     of lost to follow-up, whichever came first.~      The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing~     regimens in a urban clinic setting.~   "
121364|NCT01467336|"~     Through a prospective randomized study the aims of this study is to analyze the impact of 3~     types of rehabilitation protocols on the Optimization of the post-operative clinical and~     anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2~     supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per~     group):~        -  strict immobilization for 6 weeks then active rehabilitation,~        -  or 3 weeks of immobilization then 3 weeks of passive motion before active~          rehabilitation,~        -  or immediate passive motion for 6 weeks and then active rehabilitation.~      Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an~     arthro-CT will be performed at 1 year.~      The investigators will evaluate: constant score and rate of tendon healing.~   "
121365|NCT01467323|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and~     safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.~   "
121366|NCT01467310|"~     Research into treatments for breast cancer relies more and more on an understanding of how~     the cells of tumor tissue act when they are exposed to a new or different drug. To find~     these new or different drugs to treat cancer, researchers are looking at proteins that help~     cancer cells grow, such as a group of proteins called Kinases. In this study the~     investigators want to look at the activity of kinases when a particular experimental drug~     called GSK1120212 is administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not~     yet approved by the FDA for use in breast cancer patients. The investigators want to give~     subjects GSK1120212 for a short period of time (one week) to see how MEK and the other~     kinases function in cancer cells both before and after the study drug is given. This study~     is not intended to treat cancer, it is looking at ways that the investigators may treat~     cancer in the future.~   "
121367|NCT01467297|"~     40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be~     enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be~     compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days.~     Primary objective of the study is to evaluate the effects of the treatment on serum~     inflammatory biomarkers and the secondary objective is to evaluate the clinical and~     microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).~      The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4);~     Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy~     assessment, Day 28-30).~      The primary parameter to test the efficacy of the study medications will be the assessment~     of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of~     10% will be taken into account. The comparison between treatments will be performed at visit~     2 and 3.~   "
121368|NCT01467284|"~     The proposed site-level randomized trial will test the effectiveness of a work site~     intervention based on an ecological framework at preventing weight gain among high school~     employees in Massachusetts. The investigators hypothesis is that the intervention will~     positively impact healthy dietary patterns and physical activity, perceived organizational~     commitment, coworker influences, social support, self-efficacy, and self-control, which in~     turn will positively mediate or moderate the positive associations between the intervention~     and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the~     intervention is designed to be generalizable to high school settings across the country and~     has the potential to reduce the morbidity, mortality and economic costs of overweight and~     obesity in this important population.~   "
121369|NCT01467271|"~     The main purpose of this study is to prospectively estimate the incidence of NSF in patients~     with moderate to severe renal impairment after administration of DOTAREM®~   "
121370|NCT01467258|"~     Amantadine appears to be a specific substrate for acetylation by spermidine/spermine~     N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold~     compared to normal cells. Amantadine can be used to determine SSAT cellular activity, and~     may indicate the presence of cancer.~      This study will provide additional information in conjunction with data from a previous~     study which include cancer patients and normal health age matched controls to determine~     whether urinary excretion of acetylamantadine is predictive for the presence of cancer, and~     if so whether excretion of this metabolite is associated with any particular site of the~     tumor. Based on the results of the first study additional data in normal healthy volunteers~     is required.~      The data from both studies will be analyzed to account for subject gender, stage of disease~     at time of testing, concurrent diseases, alcohol and tobacco use and occupational~     characteristics. This is an important first step in validating a cancer detection method~     that can be implemented economically for screening of large numbers of people at sites~     remote from limited and expensive diagnostic instrumentation. Thus there is a possibility~     that this design can be prognosis biomarker as well as a positive/negative indicator.~   "
121371|NCT01467245|"~     This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for~     repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic~     hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the~     thoracic cavity and may therefore cause hypercapnia and acidosis.~   "
121372|NCT01467232|"~     Following myocardial infarct, cellular therapy is a potential approach to repopulate the~     injured myocardium, to treat heart failure and restore cardiac function. The purpose of this~     study is to assess the safety, feasibility and efficacy of intramyocardial delivery of~     selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass~     grafting in patients with chronic ischemic cardiomyopathy.~   "
121373|NCT01467219|"~     The surgical management of high-risk endometrial cancer often involves an extensive~     operation to remove lymph nodes as sites of possible cancer spread.~      18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and~     recently groups have used an intra-operative gamma probe to better localize metastatic~     disease. In this pilot study, patients with newly diagnosed early stage, high-risk~     endometrial cancer undergoing primary surgery will have a pre-operative PET scan and~     intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A~     complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET~     scan and the intra-operative probe will be calculated.~      This study addresses the feasibility of an FDG detection gamma probe in addition to a~     pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk~     endometrial cancer. The study will also evaluate the role of identifying metastatic lymph~     nodes intraoperatively that would otherwise be clinically negative.~   "
121384|NCT01467076|"~     This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1)~     in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume~     sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate~     the feasibility and safety of prolonged IPGE1 administration and determination of optimal~     dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered~     over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety~     of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale~     randomized controlled trial will be planned.~   "
121455|NCT01466153|"~     The overall purpose of the study is to determine if MEDI-551, when used in combination with~     salvage chemotherapy (bendamustine) in patients with relapsed or refractory CLL who are not~     eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to~     rituximab in the same population.~   "
121374|NCT01467206|"~     The LAST study is a Norwegian multi site randomised controlled trial that intends to assess~     the effect of a long term follow up program after stroke. The program consists of a~     coordinating physiotherapist who will encourage and motivate included patients to perform at~     least 60 minutes of intensive motor training every week and 30 minutes of physical activity~     every day for 18 months after inclusion. The primary hypothesis is that patients receiving a~     long term follow up program after stroke will have better motor function at end of follow up~     than patients receiving standard care. A total of 390 home dwelling stroke patients living~     in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic~     at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients~     will be randomised to an intervention group receiving the long term follow up program or to~     a control group receiving standard care. Motor function, mental health and physical~     functioning in daily life will be assessed at inclusion and 18 months later. The LAST study~     is funded by the Norwegian Research Council, the Norwegian University of Science and~     Technology and the Central Norway Regional Health Authority and will conclude at the end of~     2015.~   "
121375|NCT01467193|"~     This study aims at assessing the effect of standardized dietary fat load and short-term~     aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores~     (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in~     relation to FFA in endurance trained athletes and hypopituitary patients compared to~     sedentary healthy control subjects.~      Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A~     standardised exercise test can, therefore, be discriminative for the diagnosis of~     GH-deficiency in adults. This will be assessed.~      Hypothesis (ectopic fat stores)~        1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical~          activity.FFA availability may play an important regulatory role.~        2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose~          organs after fat load and physical exercise~        3. The flexibility of ectopic fat stores is related to insulin sensitivity~        4. Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at~          rest or during exercise) and therefore also for the regulation of ectopic fat stores.~        5. GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA~          availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD~        6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.~   "
121376|NCT01467180|"~     A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not~     efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off~     dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of~     Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.~   "
121377|NCT01467167|"~     Recently, a new software program for anesthesia has been developed, called Smart Pilot View.~     This program monitors the patient, the anesthetic drugs given, and the calculated depth of~     the anesthesia. The purpose of this study is to determine whether the use of this program~     improves the quality of anesthesia.~   "
121378|NCT01467154|"~     The aim of the present study is to determine whether a high dose of intravenous NAC is~     efficient in preventing CN after emergency contrast injection in patients with renal~     failure.~   "
121379|NCT01467141|"~     This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy~     in children with type 1 diabetes.~   "
121380|NCT01467128|"~     The next four decades will see a marked expansion of the elderly population in Ireland, in~     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of~     prescription medicines in Ireland and have the highest prevalence rates of major~     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and~     consequent major morbidity and mortality. Epidemiological data from the Unites States~     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that~     effective evidence based interventions can be applied to this major public health problem.~      A recently described approach to hospitalised older patients' medication optimisation is~     that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist~     with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older~     patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care~     plan for older patients and their carers where appropriate as well as feedback information~     to prescribers in the event of detecting instances of probable medication inappropriateness.~     Whenever an opportunity for medication optimisation is identified, the pharmacist discusses~     the opportunity with the prescriber who can accept or reject the intervention. At discharge~     from hospital, the pharmacist also provides written and verbal information on treatment~     changes to the patient / caregiver and GP. The intervention therefore represents a~     comprehensive pharmaceutical care approach that is based upon careful review and subsequent~     consensus on individualised pharmacotherapy. In an RCT comparison of this approach with~     standard care, older patients in the intervention arm of the study had significant~     improvements in medication appropriateness (medication appropriateness index (MAI), Beers'~     criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist~     review of older peoples' medication in hospital is a proven intervention in term of reducing~     inappropriateness of medication.~   "
121381|NCT01467115|"~     More than 50% of Head and Neck cancers are locally advanced at presentation. Although~     surgery, in combination with other modalities like radiation therapy can achieve 40-50% five~     year survival rates, resection in the head and neck region can leave patients with poor~     functional and cosmetic outcomes.~      Due to these concerns about quality of life after surgery, there has been a lot of interest~     in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy~     and biologics has showed promising results. However, questions still remain about the ideal~     combination treatment regimen.~      Based on assimilation of data from multiple sources, our study tries to identify the role of~     a potentially highly effective multi-modality regimen based on induction chemotherapy~     (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent,~     Cetuximab, and radiation therapy.~   "
121382|NCT01467102|"~     This project a European observational study on the incidence and characteristics of chronic~     post surgical pain (CPSP).~      Research Questions~        -  What is the incidence of chronic post surgical pain (CPSP) in Europe?~        -  What are the risk factors of chronic post surgical pain (CPSP) related to surgery,~          patient and anaesthesia management?~        -  What are the difference in incidence and risk factors in different European countries?~   "
121383|NCT01467089|"~     The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS)~     and tardive dyskinesia (TD) examinations conducted via live two-way video versus live~     examinations completed in-person~   "
121410|NCT01466738|"~     The purpose of this study is to evaluate the safety and clinical characteristics of a~     quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16~     will be subsequently used in viral challenge studies with new compounds that are intended to~     treat respiratory diseases.~   "
121385|NCT01467063|"~     Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though~     juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D~     tend to become less sensitive to insulin, particularly during adolescence.~      The overall objective of this project is to gain further insight into the possible benefits~     of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin~     sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators~     will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an~     IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely~     measured amounts of glucose by vein: the amount of glucose required to prevent a drop in~     blood sugar reflects the body's sensitivity to insulin. The investigators will also give an~     IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive~     isotopes to better understand how glutamine may work. This procedure will be performed in 2~     groups of 10 adolescents in the morning either after a strenuous exercise performed the~     previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject~     will be studied twice, once after taking oral GLN, once after placebo, in separate clinical~     research center (CRC) admissions a few weeks apart, in random order.~      Should the investigators hypothesis prove to be true, it would warrant long term studies to~     determine whether sustained dietary GLN supplementation can decrease insulin requirements~     and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach~     could potentially have a significant positive impact in terms of adolescent health.~   "
121386|NCT01467050|"~     The next four decades will see a marked expansion of the elderly population in Ireland, in~     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of~     prescription medicines in Ireland and have the highest prevalence rates of major~     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and~     consequent major morbidity and mortality. Epidemiological data from the United States~     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that~     effective evidence based interventions can be applied to this major public health problem.~      Recent research data indicate a cause-and-effect relationship between inappropriate~     prescription medicines and serious ADEs in older people in hospital. To date, Beers'~     criteria have been the dominant set of criteria for defining potentially inappropriate~     medicines (PIMs) in late life. Research data collected by this group show that the recently~     validated STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening~     Tool to Alert doctors to Right Treatment) identify ADEs that are causal or contributory to~     acute hospital admission in older people 2.7 times more frequently than Beers' criteria.~     Based on these findings, our hypothesis is that STOPP/START criteria have the potential to~     be used as a regular intervention for the purpose of ADE prevention in older people. A~     recent single centre randomised control trial (RCT) undertaken at Cork University Hospital~     showed that prospective application of STOPP/START criteria led to a highly significant~     improvement in medication appropriateness in older hospitalised patients compared with~     standard inpatient pharmaceutical care. Significantly, the improvement in medication~     appropriateness was maintained to the end of the study follow-up i.e. 6 months~     post-discharge. However, the ability of STOPP/START criteria to significantly reduce ADEs in~     a prospective RCT has yet to be demonstrated.~   "
121387|NCT01467037|"~     Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The~     cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would~     amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is~     an average of 8/10,000 patient-days in children < 5 years. An immunization program with a~     live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented,~     free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait~     of the disease and give critical information to the public health agencies as they struggle~     to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases~     with similar characteristics; estimate selection bias in passive laboratory-based~     surveillance; and estimate the agreement between surveillance time-series created from~     passive and active surveillance data sources.~   "
121388|NCT01467024|"~     The purpose of this study is:~        1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.~        2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive~          population.~   "
121389|NCT01467011|"~     The purpose of this study is to gather information regarding the use of Myfortic, Prograf,~     and corticosteroids in new liver transplant recipients. These three medicines help to~     prevent the body from rejecting the transplanted liver. The information the investigators~     are obtaining is data relating to the process of Myfortic absorption by the body, its~     distribution in the body, the breakdown of Myfortic in the body, and its elimination from~     the body. This absorption, distribution, breakdown, and elimination is called~     pharmacokinetics.~   "
121390|NCT01466998|"~     Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe~     enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in~     suppressing hot flashes, it is associated with increased risk for a variety of serious~     adverse effects. There is an urgent need for alternative treatments that are effective,~     safe, and easy to use. In this study, the investigators will compare two different types of~     behavioral relaxation therapies, paced respiration and music therapy, for treatment of~     menopausal hot flashes. Effects on frequency of hot flashes, other symptom and~     quality-of-life outcomes associated with hot flashes, and physiologic measures of~     sympathetic/parasympathetic activity will be examined.~   "
121391|NCT01466985|"~     This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral~     activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve,~     HIV-1-infected participants.~   "
121392|NCT01466972|"~     The purpose of this study is to evaluate the clinical benefit rate at 12 weeks from the~     addition of pazopanib to a non-steroidal aromatase inhibitor (NSAI) (letrozole or~     anastrozole) in patients with hormone receptor positive advanced breast cancer progressing~     on the same NSAI hormone therapy.~   "
121393|NCT01466959|"~     An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD~     contains a small amount of citric acid rather than acetic acid as the acidifying agent. The~     use of citrasate may lead to lower heparin requirements in hemodialysis. This is a~     randomized, double blinded, two-period crossover trial in HD patients to compare the effect~     of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.~   "
121394|NCT01466946|"~     The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are~     diagnosed later than other groups.~   "
121411|NCT01466725|"~     The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects~     with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be~     evaluated.~   "
121395|NCT01466933|"~     Children of mothers in the intervention parenting program are expected to show benefits over~     the standard care control group in terms of better cognitive/language development, less~     recent illness, and better height for age. The mothers assigned to the intervention~     parenting program are expected to evidence higher levels of home stimulation, better health~     prevention, and better dietary diversity, along with more accurate knowledge of child~     development.~   "
121396|NCT01466920|"~     The goal of this research is to fill the knowledge gap relating to why up to 20 percent of~     total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to~     answer the research question: What are the drivers of variation in the patient experience~     with primary (ie. not revision) TKA?~   "
121397|NCT01466907|"~     The aim of this study was to examine to what extent a one year population of stroke patients~     at a university hospital had well regulated risk factors and health problems one year after~     stroke, and if a structured nurse-led previous follow-up in the intervention group including~     referrals if needed could influence health outcome and risk factors one year after stroke.~   "
121398|NCT01466894|"~     This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection,~     multiple dose administration study comprising three groups, with up to 40 patients in each~     active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis~     (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to~     receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for~     clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo~     a second liver MRI scan. Patients will be followed for an additional 4 weeks for safety~     after completion of treatment.~   "
121399|NCT01466881|"~     This phase II trial studies how well alisertib works in treating patients with peripheral~     T-cell non-Hodgkin lymphoma that has come back after a period of improvement or has not~     responded to treatment. Alisertib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
121400|NCT01466868|"~     The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in~     patients with relapsed or refractory diffuse large B cell lymphoma.~   "
121401|NCT01466855|"~     This study will test if giving topotecan directly into the blood vessel of the eye will~     improve the treatment of retinoblastoma. This method is referred to as selective~     intra-ophthalmic artery chemotherapy (SIOAC).~      The goals of this study are:~        -  To find out if topotecan is an effective treatment for retinoblastoma when delivered~          directly to the ophthalmic artery (SIOAC delivery)~        -  To find out what kind of effects (good and bad) can be expected when topotecan is given~          by SIOAC~        -  To assess visual pathway function before and after the study therapy~        -  To learn more about the pharmacology (how your body handles the drug) of topotecan when~          delivered directly to the ophthalmic artery~   "
121402|NCT01466842|"~     The purpose of this study is to determine whether catheter ablation is more effective than~     antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the~     patients a subcutaneous loop recorder will be implanted.~   "
121403|NCT01466829|"~     The aims of this study is to compare healing time and quality of newly formed bone in~     cardiac surgery patients treated with PTH post-surgically and a control group treated with~     saline.~   "
121404|NCT01466816|"~     Rationale: The investigators hypothesize that a change in dietary fat quality (an increase~     in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle~     towards less accumulation of lipid metabolites and an improved insulin sensitivity.~      Objective:~        1. The contribution of dietary vs endogenous fat sources to lipid overflow in the~          circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant~          subjects vs obese insulin sensitive controls.~        2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs~          polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and~          storage, fatty acid mediated gene expression and postprandial insulin sensitivity in~          obese insulin resistant subjects.~      Study design: single-blind randomized cross-over trial~      Study population: obese males (35-70 years) with or without insulin resistance~      Intervention:~        1. 1 test meal~        2. 3 test meals with a different fatty acid composition~      Main study parameters/endpoints:~      More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle~     fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an~     increased insulin sensitivity.~   "
121405|NCT01466803|"~     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic~     factors. The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold~     and include, e.g., genetic factors, diseases, age and concomitantly administered drugs.~     Oxidation reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes~     (CYP) have been recognized as chief contributors (Guengerich 1992). We have previously shown~     that drug interactions mediated by the inhibition of CYP enzymes may be of major clinical~     significance (Olkkola et al. 1993; Olkkola et al. 1994; Varhe et al. 1994; Olkkola et al.~     1999; Palkama et al. 1999; Jokinen et al. 2000).~      Buprenorphine undergoes extensive first-pass metabolism and has low oral bioavailability of~     15 % (Cone et al. 1984). Bioavailability following sublingual administration of~     buprenorphine is higher, 50-60 % (Nath et al. 1999). After high sublingual doses of~     buprenorphine (8-24 mg), peak plasma concentrations are reached in 1 hour (McAleer et al.~     2003, Ciraulo et al. 2006) and after low sublingual doses (0.4 mg) they are reached in~     approximately 3 h (Billingham 1981). Approximately two-thirds of a buprenorphine dose is~     excreted unchanged, and the rest is metabolized in the liver and intestinal wall.~     N-dealkylation of buprenorphine mainly via CYP3A but also CYP2C8 yields norbuprenorphine,~     and glucuronidation yields buprenorphine-3-glucuronide (Cone et al. 984). Norbuprenorphine~     is excreted in the urine after subsequent conjugation. 80-90 % of buprenorphine is excreted~     by the biliary system and enterohepatic circulation (Brewster et al. 1984)~      Although few interaction studies of high-dose buprenorphine and antiretrovirals have been~     conducted (McCance-Katz EF et al. 2007), the effect of CYP3A inhibitors on the~     pharmacokinetics of low-dose buprenorphine is unknown. Because the use of buprenorphine in~     pain management is increasing after the introduction of transdermal buprenorphin patches to~     the market, it is clinically relevant to study and quantify possible interactions of~     buprenorphine with inhibitors of its CYP3A-mediated metabolism such as voriconazole.~      This study is aimed to examine the possible interactions of oral buprenorphine with~     voriconazole.~      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within~     ±15% of the ideal weight for height will be recruited for the study. The subjects will be~     submitted to physical examination, determination of previous or present chronic diseases,~     and comprehensive laboratory testing to ascertain that they are in good health. The subjects~     will fill in a modified Finnish version of the Abuse Questions (Michna et al. 2004) to~     assess their vulnerability for opioid abuse. Laboratory screening will include CBC~     (including hemoglobin, hematocrit, differential WBC, platelet count), SGOT, SGPT, alkaline~     phosphatase, BUN and creatinine, and for women a pregnancy test. Urine will be screened for~     glucose, proteins and drugs with addiction potential. Blood pressure in sitting position~     must be within normal limits. Base line ECG must be normal.~      Placebo and voriconazole should always be ingested with food, except the first dose on day~     5.~      On day 5, the challenge dose of 0.2 or 3.6. mg of oral buprenorphine (Temgesic,~     Schering-Plough) will be administered at 11.00, i.e. 1 h after the last dose of placebo or~     voriconazole. The dose is 3.6 mg after placebo and 0.2 mg after voriconazole. If necessary,~     naloxone (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the~     severe adverse effects of buprenorphine. For nausea and vomiting, intravenous tropisetron~     will used, if needed.~      The volunteers will fast at least 8 h before the administration of buprenorphine and they~     will have a standard meal 4 h and 8 h afterwards. Ingestion of alcohol, coffee, tea, cola,~     energydrinks and grapefruit juice is not allowed during the test days, nor is smoking~     permitted.~      The interval between the study phases will be four weeks.~   "
121406|NCT01466790|"~     The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977~     (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1~     hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or~     are HCV treatment-naive (patients who never received treatment for HCV infection).~   "
121407|NCT01466777|"~     The aim of this study is to compare the robotic-assisted laparoscopic surgery to the~     traditional laparoscopic surgery in endometrial cancer patients.~      The study is prospective and the patients are randomised into two groups of 50 patients~     each. Randomisation is done with Minim-programme and patients age and Body mass index are~     taken into account.~      The primary endpoint is the operation time. The number of patients in this study is based on~     the non-inferiority design. Presumption is that the operation time in robotic-assisted~     laparoscopy will be 25% longer.~      Secondary endpoints include:~        1. bleeding~        2. complications~        3. conversions~        4. number of pelvic lymph nodes~   "
121408|NCT01466764|"~     The investigators hypothesize that perioperative administration of anakinra will reduce~     incisional pain by lowering the concentration of inflammatory mediators in surgical wounds.~     This knowledge is important because it suggests a new, previously unexplored pharmacological~     target for the control of postoperative incisional pain.~   "
121409|NCT01466751|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in alleviating symptoms and improving emotion regulation in psychiatric~     populations. It will increase understanding of psychopathology at a neural-circuit level and~     aid development of new non-pharmacological treatment for emotion regulatory deficits.~   "
121439|NCT01466361|"~     This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for~     a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no~     active).~   "
121412|NCT01466712|"~     Inuvair® is a novel fixed combination product used in the treatment of asthma and under~     clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is~     able to target the whole bronchial tree, including the small airways and hence, is expected~     to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its~     action on the small airways is not directly demonstrated thus far. By way of contrast, dear~     evidence is present that treatment with bronchodilators alone does not beneficially alter~     small airway function. The study hypothesis states that the effects of inhaled~     corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.~   "
121413|NCT01466699|"~     The purpose of this study is to investigate whether and what extent blood pressure~     variability is associated with arterial stiffness and carotid atherosclerosis, furthermore~     to compare the difference in the relationship of the types of blood pressure variability~     with arterial stiffness and carotid atherosclerosis.~   "
121414|NCT01466686|"~     To evaluate the safety and effectiveness of low dose rate radiation therapy plus~     temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic~     Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery~     followed by radiation surgical resection followed by adjuvant radiation therapy plus~     temozolomide.~   "
121415|NCT01466673|"~     The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and~     Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment~     of female participants with mild to moderate acne vulgaris (pimples).~   "
121416|NCT01466660|"~     This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in~     first-line treatment setting with patients who are having epidermal growth factor receptor~     mutation positive advanced adenocarcinoma of the lung.~   "
121417|NCT01466647|"~     This is a open single-center, explorative, Phase I pilot dose finding study including~     patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and~     carboplatin.~   "
121418|NCT01466634|"~     Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain.~     Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES~     in obstructive coronary artery disease.~   "
121419|NCT01466621|"~     The present proposal is designed to investigate the response to CRT in patients who were~     previously paced from the right ventricle (RV). The negative physiologic and structural~     changes associated with chronic RV pacing are well documented, but patient response~     following upgrade to CRT after chronic RV pacing has not been well characterized in a large~     cohort.~   "
121420|NCT01466608|"~     The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and~     lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia~     patients.~   "
121421|NCT01466595|"~     This study is being done to see whether rifaximin, an antibiotic that works in the~     intestines, can lower the amount of germs in the intestines of HIV infected persons. It is~     possible that when the amount of these germs is lowered, an HIV-infected person's immune~     system will become less active and will have a better chance of recovering. Also, the study~     will evaluate the safety of using rifaximin in HIV-infected subjects.~   "
121422|NCT01466582|"~     In this prospective cohort study the investigators will assess the prevalence and incidence~     of a broad range of age-related co-morbidities and their (known) risk factor among~     HIV-patients and HIV-negative controls. HIV might cause premature onset or accelerated aging~     and could therefore result in an increase of age-related comorbidities when compared with~     controls.~   "
121423|NCT01466569|"~     The purpose of this study is to determine the safety and tolerability profile including the~     dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of~     epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with~     chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.~   "
121424|NCT01466556|"~     The aim of this study is to determine the prevalence of metabolic syndrome amongst obese~     children in our region with a body mass index (BMI) above the 95th percentile for age and~     sex.~   "
121425|NCT01466543|"~     The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral~     blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive~     impairment subjects.~   "
121426|NCT01466530|"~     Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful~     effects on either mother or baby. The investigators postulated that the use of sublingual~     misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce~     maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents,~     without harmful effects on either mother or baby. Therefore, the present study was designed~     to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss,~     uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean~     delivery under isoflurane anaesthesia.~   "
121427|NCT01466517|"~     A PHASE IV, OPEN LABEL, RANDOMIZED, TWO-WAY CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE~     RELATIVE BIOAVAILABILITY OF IBUPIRAC 40MG/ML (LABORATÓRIOS PFIZER LTDA) ORAL SUSPENSION FORM~     VERSUS ALIVIUM® 50MG/ML (MANTECORP INDÚSTRIA QUÍMICA E FARMACÊUTICA LTDA.) ORAL SUSPENSION~     FORM, UNDER FASTED CONDITIONS IN HEALTHY VOLUNTEERS.~   "
121440|NCT01466348|"~     A reduction in alertness and lower levels of performance are commonly associated with the~     common cold. Paracetamol has been shown to be more effective than placebo in treating~     symptoms associated with upper respiratory tract infection; caffeine has been shown to~     increase levels of alertness and improve performance of people suffering from colds. This~     study will investigate any improvement in alertness and performance based on cognitive~     function and mood assessment in subjects suffering from the common cold, when taking a novel~     paracetamol and caffeine combination verses paracetamol alone.~   "
121456|NCT01466140|"~     The primary objective of this study is to determine whether exploring the request for help~     more thoroughly improves patient satisfaction in general practice (primary care).~   "
121457|NCT01466127|"~     The purpose of the study is to learn how differences in learning under mildly-stressful~     circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the~     body. The investigators will also examine the impact of any anxiety, depression, and stress~     related symptoms on learning processes.~   "
121428|NCT01466504|"~     Skin toxicity is a frequently observed side effect in the era of molecularly targeted~     therapies. Skin toxicity following administration of protein kinase inhibitors such as~     sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient,~     resulting in dose reduction and discontinuation of treatment. The mechanisms of skin~     toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly~     understood. Further research is warranted to better understand the pathophysiology of~     drug-related skin toxicity in this setting and develop correction strategies. This study~     tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and~     keratinocyte differentiation and skin remodeling.~      Eligible study participants will be evaluated clinically for evidence of skin toxicity~     during their visits to the outpatient Oncology clinics. Study participants will undergo skin~     biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12~     weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in~     Oncology clinics by the study investigators and clinic support staff.~      Study participants will undergo both skin biopsies regardless of whether they develop a~     rash. In patients who develop a rash the most representative lesion will be biopsied. A~     normal appearing area of skin will be biopsied in participants who do not develop a rash.~   "
121429|NCT01466491|"~     The purpose of this study is to determine the level of pain women experience with a surgical~     abortion and the effect that varying paracervical block techniques might have on that pain.~     These different techniques involve wait time following the injection as well as the number~     of sites injected.~   "
121430|NCT01466478|"~     The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus~     calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus~     calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle,~     using the psoriasis plaque test modified from the method developed by KJ Dumas and JR~     Scholtz.~   "
121431|NCT01466465|"~     Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced~     allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is~     limited by a long treatment time and high non-responder frequency. Based on experimental and~     epidemiological evidences we hypothesize that vitamin D can act as an effective~     immunomodulatory adjuvant to overcome these limitations.~   "
121432|NCT01466452|"~     This study is a randomized open label study that implies the administration of asprin~     according to three different regimens.~      The aims of the study are:~        -  to establish whether coronary artery bypass surgery and / or aortic valve replacement~          surgery with bioprostheses is associated with changes in the rate of platelet~          regeneration that can reduce the effectiveness of aspirin administered at a dose of~          100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.~        -  to determine whether these patients need a different (shorter) interval of~          administration in order to completely and permanently inhibit the platelet COX-1.~      The endpoints of this study are:~      - To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours~     after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary~     8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets~     crosslinked at 12 and 24 hours after administration of aspirin~   "
121433|NCT01466439|"~     The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has~     demonstrated its efficiency in both depression and schizophrenia. However if its efficiency~     has been recognized by the scientific community and the clinicians, its action on neurons~     and cerebral networks remains debated.~      In the motor regions, the different rTMS studies generally use frequencies of stimulation of~     1 to 40 Hz with differential effects; the low frequencies being associated with an~     inhibitory effect whereas highest frequencies have rather some facilitator effects as~     attested by the motor responses. What is valid for the motor system is not however~     necessarily applicable to other cerebral regions that have different neuronal organizations.~     If it is easy to observe these opposite effects of rTMS on the motor system (presence or~     absence of movements), these potential effects on more integrated cortex involved in high~     level functions have not been proved.~      One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions~     would be to study the modifications of the EEG before and after rTMS and to see if a~     differential effect of the high and low frequencies of stimulation exists. Up to now, the~     studies having coupled these two techniques have observed modifications of the brain~     electric activity only during some seconds to minutes after rTMS, what appears in contrast~     with the clinical effects observed after a long delay (several days).~      The contribution of our research resides in the use of the paradigm of suppression of P50~     evoked potential component before and after rTMS tested with low and high frequencies of~     stimulation. This paradigm consists in two identical auditory stimuli presented at a very~     short interval (generally 500 milliseconds), the second sound generating a P50 wave of~     weaker amplitude than the first or being completely abolished in healthy subjects. However,~     this effect that has been well studied could result from an inhibitory action due to the~     gabaergic interneurons on the pyramidal neurons of the cortex. Thus, the investigators~     hypothesize that high frequency rTMS would have a facilitator effect on temporal lobe and so~     would induce no suppression of the P50 after-rTMS whereas low frequency rTMS would induce an~     inhibitory effect marked by a greater suppression of the P50.~      Methods: 30 healthy subjects (of which 16 women) will be included after written consent.~     They will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30~     days interval. An EEG and a P50 evoked potential will be done before and after rTMS. The~     site of stimulation will be determined by neuronavigation and will correspond to the maximal~     activation cluster generated by a language task during functional magnetic resonance~     imaging. The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary~     effects will be evaluated (UKU adapted). The secondary criteria are the comparisons before~     and after rTMS of EEG spectrums in the alpha, beta and gamma bands.~   "
121434|NCT01466426|"~     This pilot study aims at validating 18F-flourodeoxyglucose positron emission~     tomography/computed tomography (FDG-PET/CT) in the detection and characterization of venous~     thromboembolism (VTE) in the entire human body, especially deep venous thrombosis (DVT) and~     pulmonary embolism (PE). On completion of this study the investigators will hopefully be~     able to demonstrate the importance of functional/molecular imaging technique in managing~     patients with this common and potentially fatal disorder.~   "
121435|NCT01466413|"~     This is an early phase study comparing two fixed dose of the study compound ELAPR and a~     Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of~     the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each~     treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a~     3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each~     injection will consist of 20-30ul of product delivered using a 30Gx¼ needle.~   "
121436|NCT01466400|"~     It is hypothesized that there will be no difference in the breath hydrogen excretion between~     the 2 different prebiotic formulas.~   "
121437|NCT01466387|"~     This study compares the safety and immunogenicity profile of several travel vaccines given~     alone or concomitantly with MenACWY-CRM to healthy adults.~   "
121438|NCT01466374|"~     The purpose of this study is to determine whether BMS-936557 is effective for the treatment~     of moderate to severely active Crohn's Disease in patients who have had insufficient~     response and/or intolerance to conventional therapy for Crohn's Disease.~   "
121441|NCT01466335|"~     Ronacaleret is an orally administered CaSR antagonist which has previously been demonstrated~     to transiently increase PTH in both animals and humans. Additional studies in~     post-menopausal women and patients with distal radial fractures have demonstrated both~     anabolic and catabolic effects on bone biomarkers and scans of bone density. Based on~     ronacalerets ability to interact with the CaSR inducing PTH release and activating~     endogenous bone metabolism of both osteoblasts and osteoclasts, it is our intention to~     evaluate the impact activation of this pathway has on mobilization of Hematopoietic stem~     cell (HSCs) into the periphery.~      This is an adaptive, phase I, randomized, single centre, double-blind dose finding,~     parallel-group, multi-cohort placebo controlled study of the efficacy and safety of~     ronacaleret in up to 45 healthy human volunteers. Cohorts of eligible subjects will be~     studied for periods up to 28 days. Total daily doses of ronacaleret will range from 100mg,~     up to 400mg and be administered for a maximum of 28days. The first part of this study will~     evaluate several doses and schedules of ronacaleret, run in parallel, with respect to their~     ability to affect mobilization of CD34+ cells into the peripheral circulation. In subsequent~     cohorts of the study we will utilize information obtained from previous cohorts to further~     refine and optimise those dosing paradigms which show efficacy. For the first cohort of~     study participants; the study will commence with 6 days of dosing in an inpatient setting~     followed by 21 days of continued dosing and evaluation as an outpatient, with a series of~     regularly scheduled visits, with the final visit on day 28. The study period will include~     evaluations of pharmacokinetic and pharmacodynamic parameters along with standard laboratory~     and safety evaluations. The second cohort may be treated with ronacaleret for periods~     ranging from 14 to 28 days in order to optimise the treatment paradigm with respect to~     pharmacodynamic efficacy. The PK/PD of each group in cohort one will be utilized to make~     adjustments in the total daily dose, dose frequency and or duration of dosing investigated~     in cohort 2. Decisions will be made as to dropping doses based on the PK/PD results and any~     safety considerations. An initial equal randomization amongst groups within the first cohort~     may be adjusted to allow for other randomization strategies as various doses and schedules~     are assessed.~      The objective of this study is to characterise the dose-response curve for ronacaleret with~     respect to safety and efficacy based on changes in peripheral CD34+ cell counts. Results~     obtained from this study will inform us: of optimized doses, schedules, and durations of~     treatment for future studies. Additional cohorts may be added to further explore the dose~     schedule and duration if required. The exact number of cohorts studied will depend on the~     results obtain from the prior groups and the desire to explore a variety of doses and~     schedules. The aims of the present study (CR9115166) include an assessment of the~     pharmacodynamic effects (mobilization of CD34+ cells), safety, tolerability, and~     pharmacokinetics of ronacaleret in healthy human volunteers.~   "
121442|NCT01466322|"~     GSK2018682 is a potent and selective agonist for the sphingosine-1- phosphate receptor~     subtype 1 (S1P1) with the potential to be an effective treatment for multiple sclerosis~     (MS). The immunomodulatory properties of GSK2018682 are related to functional antagonism of~     S1P1 on lymphocytes, resulting in sequestration of lymphocytes within the lymphoid organs,~     rendering them incapable of migrating to sites of inflammation and leading to lymphopenia.~     Orally administered GSK2018682 is very effective in murine experimental autoimmune~     encephalomyelitis (EAE), an animal model of human MS. This study will assess the relative~     bioavailability of different oral formulations of GSK2018682 in healthy volunteers. A tablet~     formulation is desired for progression into future clinical safety and efficacy studies as~     the current capsule formulation is not suited to large scale manufacture. The information~     obtained in this study will help to establish the optimal dosing form for future studies,~     and also determine the effect of food on the pharmacokinetics of GSK2018682.~   "
121443|NCT01466309|"~     Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been~     reported its safety and efficacy in Caucasians at least in the short-term. However, there~     has been no reports in Thai patients. The objectives of this study is to investigate its~     efficacy and safety in Thai patients with OSA.~   "
121444|NCT01466296|"~     The overall objective is to improve the functional status of Middle East adolescents with~     disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular~     stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied~     research project.~   "
121445|NCT01466283|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is studying biomarkers in patients with rhabdomyosarcoma.~   "
121446|NCT01466270|"~     RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by~     chemotherapy.~      PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive~     dysfunction after chemotherapy in female breast cancer survivors.~   "
121447|NCT01466257|"~     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.~   "
121448|NCT01466244|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent~     head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.~   "
121449|NCT01466231|"~     Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered~     to the patient until progression, unacceptable toxicity, complete response or inability of~     the subject to comply with study requirements. Feasibility of surgical resection will be~     assessed after every 2 cycles of the treatment in patients with partial response.~   "
121450|NCT01466218|"~     This project will evaluate the effects of World Trade Center (WTC) exposure in WTC~     responders 10-13 years following the events of 9/11. Prior studies have described persistent~     pulmonary function abnormalities in a significant portion of responders. The investigators~     study seeks to examine the relationship between pulmonary function abnormalities and other~     markers of chronic cardiopulmonary disease and further elucidate the pathophysiologic~     effects of exposure to inhaled particulate matter (PM) on 9/11. This study will provide~     critical information regarding risk of exposure to PM, risk factors for disease and~     potential for improvements in diagnosis and treatment.~   "
121451|NCT01466205|"~     Currently, no study to date has directly tested a selective D1R agonist in relation to the~     cognitive impairment of Schizophrenia without the confound of neuroleptics. The~     investigators propose to examine the efficacy of DAR-0100A, a highly selective, full D1R~     agonist supported by pre-clinical and preliminary pilot clinical data, in ameliorating the~     cognitive deficits in Schizotypal Personality Disordered subjects receiving no medications~     including antipsychotics.~      The investigators hypothesize that 1) Baseline primary outcome measures will be impaired in~     Schizotypal personality disorder (SPD) subjects compared to controls, 2) SPD subjects on~     DAR-0100A will show improvement on primary measures greater than healthy controls and SPD~     patients randomized to placebo, and 3) SPD patients will show significant improvements on~     primary outcome variables on drug compared to placebo.~   "
121452|NCT01466192|"~     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and~     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous~     treatment.~   "
121453|NCT01466179|"~     The purpose of this study is to confirm whether the bispecific T cell engager antibody~     blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or~     refractory Acute Lymphoblastic Leukemia (ALL).~   "
121458|NCT01466114|"~     Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems~     with cognition. Currently, there are no FDA-approved treatments targeting cognitive function~     in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill,~     used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing~     as compared to treatment with a placebo pill in combination with standard anti-inflammatory~     drugs in women with MS.~   "
121459|NCT01466101|"~     Pregabalin will decrease the total amount of opioid required in patients undergoing total~     abdominal hysterectomy. In addition, pregabalin will decrease the incidence of~     opioid-related side effects in patients undergoing total abdominal hysterectomy.~   "
121460|NCT01466088|"~     Alzheimer's disease is the most common form of dementia and is the fourth leading cause of~     death among people 65 years of age and older. The global prevalence of the disease will~     increase significantly as the population ages, unless preventative treatments can be~     identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to~     an approved medication (donepezil) shown to improve cognition and function in patients with~     Alzheimer's disease.~   "
121461|NCT01466075|"~     The purpose of this study is to demonstrate that untrained subjects who have diabetes or~     pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and~     obtain valid glucose results.~   "
121462|NCT01466062|"~     To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of~     24 months or less with immunocompromised medical conditions.~   "
121463|NCT01466049|"~     The purpose of this study is to evaluate new biomarkers for patients presenting to a~     physician for surgery to remove a mass in their pelvis and to continue to evaluate these~     types of patients using the ROMA algorithm for post-market benefits.~   "
121464|NCT01466036|"~     Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In~     addition to blocking the formation of new blood cells in tumors, cabozantinib also blocks~     pathways that may be responsible for allowing cancers cells to become resistant to other~     anti-angiogenic drugs. Cabozantinib has been studied or is being study in research studies~     as a possible treatment for various types of cancer, including prostate cancer, brain~     cancer, thyroid cancer, lung cancer, and kidney cancer.~      In this research study, the investigators wish to learn if cabozantinib is effective in~     treating patients with pancreatic neuroendocrine and carcinoid tumors.~   "
121465|NCT01466023|"~     Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant,~     affecting the majority of preterm infants, born less than 30 weeks of gestational age. It is~     defined as a temporary postnatal reduction from cord values in serum levels of T4 and FT4,~     but with normal thyroid-stimulating hormone (TSH) levels.The etiology of THOP is complex and~     multifactorial. Loss of maternal T4, limited postnatal thermogenesis, hypothalamic-pituitary~     immaturity, limited thyroid gland reserve, persistent fetal thyroid hormone metabolism and~     predisposition to nonthyroidal illness syndrome are several factors that contribute in less~     or more intensity to THOP.The association between THOP and poor neurodevelopmental outcome~     is well established and several therapeutic clinical trials have been set up. However, there~     is currently no evidence for prophylactic or therapeutic supplementation with thyroxine (T4)~     for premature infants with THOP. One study of van Wassenaer et al. showed a beneficial~     effect of treatment of THOP in a subgroup of preterm infants with gestational age less than~     28 weeks, but a reverse effect in the group with a gestational age of 29 weeks. This is an~     illustration of the limited comprehension of the pathophysiology of THOP.~      Although studies about THOP usually involves the preterm infants born at 33 weeks or~     earlier, one study of Paul et al. showed a decreased thyroid function in late preterm and~     term infants with respiratory distress syndrome as function of severity of illness.~     Unpublished data of our center showed also the presence of THOP, although less frequent, in~     the group of late preterm infants. Other data about this group of preterm infants are~     scarce.~      During the first half of pregnancy, the fetus is completely dependent of maternal thyroid~     hormone supply and the fetal thyroid gland starts thyroid hormone secretion from about 17-19~     weeks of gestational age. Conditions of maternal (sub)clinical hypothyroidism are associated~     with complications like hypertension, preterm birth, low birth weight, placental abruption,~     and fetal death. One can wonder if there are compensating mechanisms in the placenta,~     providing the fetus with sufficient thyroid hormone in cases of compromised thyroid supply.~     One study showed that total placenta deiodinase type 3 (D3) activity in pregnancies with~     severely hypothyroid fetuses was not significantly lower than in euthyroid controls. Two~     studies showed increased monocarboxylate transporter 8 (MCT8) and decreased MCT10 expression~     within placentae of pregnancies complicated by IUGR. As far as we know, nothing is known~     about possible compensating effects in placentae of mothers with subclinical hypothyroidism~     and the possible influence on the development of THOP.~      Maternal subclinical hypothyroidism during pregnancy is a predisposition for the development~     of overt hypothyroidism. The influence of maternal thyroid antibodies during pregnancy~     towards thyroid hormone function of the fetus and consequently neurodevelopmental outcome is~     still not clear. One single study of Negro et al. showed that euthyroid pregnant women who~     are positive for thyroid peroxidase antibodies (TPOAb) develop impaired thyroid function,~     which is associated with an increased risk of miscarriage and premature deliveries. They~     also showed that substitutive treatment with levothyroxine (LT4) is able to lower the chance~     of miscarriage and premature delivery.A study of Pop et al. concluded that children of~     pregnant women who had elevated titers of TPO-Ab but normal thyroid function are at risk for~     impaired development.Nothing is known about the possible influence of maternal thyroid~     antibodies towards the development of THOP, although a theoretical link is possible.~      The investigators want to investigate whether there are compensatory mechanisms in placentas~     of premature born infants and whether the maternal thyroid hormone condition is a prediction~     of the development of THOP in the premature infant. The investigators want to investigate~     the differences between several groups of preterm infants: 24-28 weeks, 28-32 weeks and~     32-36 weeks. The further aim of this study is to investigate the impact of maternal thyroid~     hormone condition during pregnancy on neurodevelopmental outcome of the neonate.~      In Belgium, 8% of the newborns are born preterm. There are about 2000 deliveries each year~     in the University Hospitals Leuven. Between 2 and 5% of all pregnant women are considered to~     have subclinical hypothyroidism and preterm birth is almost 2-fold higher in women with~     subclinical hypothyroidism.The incidence of THOP is 30 %. We performed a statistical power~     calculation with a confidence level of 95%. Given the above data and with the assumption~     that 50% of the premature babies born to a hypothyroid mothers will develop THOP, we need to~     include 320 patients who give premature birth to obtain a statistical power of 80%.~     Therefore, the inclusion time will be 2 years.~   "
121466|NCT01466010|"~     Purpose of the study:~      To retrospectively determine the clinical results in an unselected group of consecutive~     patients with osteoid osteoma treated by surgery.~      Materials and Methods:~      In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma~     at any location, the clinical symptoms and imaging findings (radiographs and computed~     tomography (CT)) were assessed before and after surgery. There were no exclusion criteria~     for this study. A good response was defined as disappearance of symptoms that were~     manifested at presentation and were attributed to osteoid osteoma. Clinical assessment after~     the procedure was performed prior to discharge; within 2 weeks after the procedure; and at~     3, 6, and 12 months follow-up. After 24 months, a postal questionnaire was used for~     assessment. Radiographic evaluation (radiographs and thin-slice CT) was performed routinely~     pre-operatively and one year after surgery.~      In case of persisting or recurring symptoms the follow-up protocol was again performed~     according to the initial protocol.~      All patients gave their informed consent both for the surgical intervention as for the use~     of their patient data in this retrospective study.~   "
121467|NCT01465997|"~     Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as~     monotherapy in newly or recently newly diagnosed subjects with primary safety variables~     including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs,~     reporting of Serious AEs (SAEs).~   "
121468|NCT01465984|"~     The purpose of this study is to determine whether Iv paracetamol is as effective as Iv~     Morphine sulfate on control of the acute pain in Patient with limb trauma.~   "
121469|NCT01465971|"~     One of the major challenges in adapting to high altitudes is that with increasing altitude~     sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none~     regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently~     to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their~     EEG-recordings that the sleep architecture (the regular succession of the particular sleep~     phases) is disturbed by repeating arousals which occur due to an irregularity in the~     breathing rhythm.~      The purpose of this study is to create a better understanding of the underlying mechanisms~     that lead to failed acclimatization and AMS, due to sleep disturbance.~   "
121470|NCT01465958|"~     The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and~     tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to~     intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age~     with Primary Immunodeficiency.~   "
121471|NCT01465945|"~     Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove~     rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice~     to close the defect or leave the defect open and naturally close. Currently, both options~     are accepted as standard care.~      Leaving the defect open to close naturally has some possible advantages, including shortened~     operation time and similar rates of postoperative complications. However, there is some~     concern that not surgically closing the defect may lead to more postoperative pain and delay~     in recovery.~      The study will be a double blind randomized controlled trial and determine whether patients~     who have rectal wall defect sutured closed have less post-operative pain compared to~     patients whose defect is left open.~   "
121472|NCT01465932|"~     The program of stretching, strengthening and proprioception is more effective than~     stretching and strengthening program in nursing, with rotator cuff disorder, according to~     indicators of quality of life and job satisfaction.~   "
121473|NCT01465919|"~     The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in~     depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with~     chronic hepatitis C.~   "
121485|NCT01465763|"~     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in~     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one~     of following treatments for ulcerative colitis: oral steroids,~     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.~   "
121474|NCT01465906|"~     Phrase: IV~      Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)~      Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium~     bromide for relieving dyspnea symptom of COPD~      Design: a multi-centre randomized parallel blank control study~      Case number: test group 80, control group 80, totally 160~      Site number:7~      Study period: 2010.9 - 2011.8~   "
121475|NCT01465893|"~     This study examines the effect of vitamin D on Retinal changes in patient with optic~     Neuritis.~   "
121476|NCT01465880|"~     The purpose of this study is to develop a fit-for-purpose biochemical verification tool that~     can be used to detect concomitant use of a few (less than 5) conventional cigarettes.~   "
121477|NCT01465867|"~     Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab)~     autoantibodies are strongly associated with an increased risk of miscarriage and premature~     deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other~     supplementations in euthyroid-Ab positivity during pregnancy has not been established. The~     development of a safe and effective intervention that modulates inappropriate inflammatory~     responses could be a very important component of prevention against adverse health outcomes~     during pregnancy.~      The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily~     dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in~     Se-non-deficient patients with autoimmune thyroiditis (AIT).~      The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and~     hypothyroidism.~      Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been~     implicated in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.~      The purpose of the present study is performed to establish the effect of Se supplementation~     in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60~     days) on Ab trend, thyroid function and structure, implantation rates, pregnancy rates,~     pregnancy outcome and number of obstetrical, fetal and neonatal complications.~   "
121478|NCT01465854|"~     Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST~     (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT),~     focuses on this entity. It is a national, multicentric, prospective epidemiological study.~     Main objective is to describe the clinical and molecular epidemiology of LCINS in a large~     French cohort composed by cases newly diagnosed in participating centres (around to 1000~     patients expected). The clinical component of the study is based on collecting data directly~     from the patient through a standardized questionnaire during a telephone interview with a~     health professional. The biologic component includes a blood sample collection. A large~     genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to~     provide concrete answers to clinicians and patients questions about this new and frequent~     entity.~   "
121479|NCT01465841|"~     This is a prospective, multi-center study of patients with intracranial or peripheral~     aneurysms who are treated by the PC 400 System. The primary objective is to gather post~     market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial~     and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral~     aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each~     patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner.~     Long term follow-up to one year will be conducted in accordance to the standard of care at~     each participating hospital.~   "
121480|NCT01465828|"~     Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in~     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention~     (PCI) with drug eluting stent(s. Interindividual variability in platelet response to~     clopidogrel has been reported, with several mechanisms being implicated for high~     post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated~     with an increased risk of adverse events after PCI. Studies in patients on chronic~     clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently~     present and independently predictive of adverse events. Optimization of platelet inhibition~     in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12~     inhibitors is a controversial issue, mostly studied in post PCI patients, while no data~     exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel~     treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled~     will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg~     a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR~     measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours~     after the last study-drug dose, will follow by crossover directly to the alternate therapy~     for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will~     return for the clinical and laboratory assessment as did on Day 14 visit.~   "
121481|NCT01465815|"~     This phase I/II trial studies the side effects and best dose of linsitinib when given~     together with erlotinib hydrochloride and radiation therapy after surgery in treating~     patients with advanced or recurrent head and neck cancer. Erlotinib hydrochloride and~     linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy together with erlotinib hydrochloride and linsitinib may kill more tumor cells.~     Giving these treatments after surgery may kill any tumor cells that remain after surgery.~   "
121482|NCT01465802|"~     To assess the impact of prophylactic treatment on the incidence of adverse events in~     advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single~     agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the~     incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation~     (HER-1 mutation, HER-2 mutation or HER-2 amplification).~   "
121483|NCT01465789|"~     The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic~     risk in children. The study hypothesis is that a combination of salivary biomarkers will~     predict the presence of risk factors including impaired fasting glucose, hypertension and~     dyslipidemia and will reflect changes in these risk factors over time.~   "
121484|NCT01465776|"~     This pilot phase I trial studies freeze-dried black raspberries in treating patients with~     oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to~     keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat~     oral cancer~   "
121486|NCT01465750|"~     Cancer is the leading cause of mortality in the investigators country. According to the~     statistics of the Department of Health, the incidence of ovarian cancer increased in recent~     years and the mortality rate is highest in all gynecologic malignancies in Taiwan. Ovarian~     cancer becomes a more and more important disease gradually in the field of gynecologic~     malignancies. The classification of histology in ovarian cancer included epithelial ovarian~     cancer、germ cell tumors、sex-cord cell tumors…etc. Epithelial ovarian carcinoma is the most~     common ovarian cancer clinically. Early diagnosis is difficult due to the lack of obvious~     initial symptoms, so ovarian cancer patients are usually at advanced stage when the~     diagnosis is confirmed. The prognostic parameters for ovarian carcinomas include tumor~     stage, histological subtype, degree of malignancy, residual tumor after surgical~     intervention and the response to chemotherapy. However, the possible etiology and mechanism~     of ovarian cancer is still unclear. However, there is no epidemiologic data of ovarian~     cancer in Taiwan. Therefore the investigators propose this study to use Taiwan registry~     database provided by Department of Health to analyze the epidemiology and prognosis of~     ovarian cancer patients in Taiwan.~   "
121487|NCT01465737|"~     Endometrial cancer is the second most common gynecologic cancer in Taiwan. Two types of~     endometrial cancer may be distinguished by standard clinicopathologic criteria; type I~     tumors are of low grade, endometrioid histology, estrogen related, and have a good~     prognosis, whereas type II tumors are high grade, of non-endometrioid histologies, unrelated~     to estrogen, and have a poor prognosis. Several clinicopathological parameters were reported~     to correlate with prognosis of endometrial cancer including tumor FIGO stage, cell type,~     cytological grading, depth of myometrial invasion, tumor size, lymph node status, and etc.~     However, there is no epidemiologic data of endometrial cancer in Taiwan. So the~     investigators propose this study to use Taiwan registry database provided by Department of~     Health to analyze the epidemiology and prognosis of uterine cancer patients in Taiwan.~   "
121488|NCT01465724|"~     The current prevalence of hypertension as part of the metabolic syndrome is substantial and~     is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous~     system (SNS) activity has been identified as a common and key factor in disease states as~     obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to~     the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation~     (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central~     nervous system, has been shown to be an effective means of modulating elevated SNS activity.~      This current study is an observational feasibility study, with the aim to investigate the~     effect of renal denervation on changes in insulin resistance and blood pressure in patients~     with obesity related hypertension. The investigators will study different variables: a~     laboratorial set, a set of blood pressure measurements and a set of investigations in the~     vascular laboratory.~      Hypothesis~        -  The investigators hypothesize that renal denervation has a beneficial effect on insulin~          resistance.~        -  The investigators hypothesize that there will be no complications related to the device~          or procedure.~   "
121489|NCT01465711|"~     The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone~     Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive~     Care Unit after abdominal surgery and compare PPS with other blood parameters, including~     C-Reactive Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin~     (PCT).~   "
121490|NCT01465698|"~     NURSE-RCT is a randomized controlled trial which aims at prevention of evolution of chronic~     low back pain (LBP) and related disability in female nurses.~      The study investigates the effectiveness and financial feasibility of six months~     neuromuscular training and counselling, and their combination on LBP, movement dysfunction~     and fear-avoidance behaviour.~      The target for neuromuscular training is to reduce movement dysfunction and motor control~     impairments, caused by trauma and subfailure injuries of spinal ligaments. Training aims at~     enhancement of motor control of lumbar neutral zone in different positions and movements,~     balance, coordination, trunk muscle endurance and leg strength.~      The target for counselling is change in attitudes and behaviour, which help to reduce the~     fear of pain and encourage to physical activity and other physical tasks.~      The hypothesis is that together neuromuscular exercise and counselling have a stronger~     influence on LBP, movement dysfunction and fear-avoidance behaviour than either used alone.~      Assessments of effectiveness will be conducted after six, 12, and 24 months of the beginning~     of interventions.~   "
121491|NCT01465685|"~     This study compares the interactive emotional/subjective effects of single doses of~     3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and methylphenidate, a dopamine (DA) and~     norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to~     determine the role of transporter mediated DA and NE release in the subjective response to~     MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the~     subjective response to MDMA.~   "
121492|NCT01465672|"~     Water imbalance and consecutive electrolyte disturbances are common in the postoperative~     course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may~     complicate the postoperative course in as many as 30% of patients. Early and accurate~     diagnosis of water and electrolyte disturbances postoperatively is important for an adequate~     fluid and drug administration. However, identifying the causes is challenging/ ambiguous in~     clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a~     straightforward diagnosis, though, its measurement is cumbersome. ADH is derived from a~     larger precursor peptide along with copeptin, which is a more stable peptide directly~     mirroring the production of ADH. Copeptin can be assayed readily in plasma. Aim: To~     investigate whether copeptin can accurately diagnose postoperative disturbances of water~     homeostasis (i.e. Diabetes insipidus and SIADH) in a cohort of patients undergoing~     intracranial tumor surgery.~   "
121493|NCT01465659|"~     This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib~     hydrochloride when given together and to see how well they work in treating patients with~     advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective~     treatment for patients with PNET.~   "
121494|NCT01465646|"~     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of~     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine~     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as~     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered~     as a reference solution without iodine.~   "
121495|NCT01465633|"~     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of~     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine~     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as~     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered~     as a reference solution without iodine.~   "
121496|NCT01465620|"~     Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic~     syndrome can induce a peripheral neuropathy. To investigate the effect of physical training~     and diet education on neuropathic symptoms and neurophysiological parameters of patients~     with metabolic neuropathies.~   "
121497|NCT01465607|"~     This project seeks to determine the personal and organizational conditions that are most~     conducive to the widespread adoption by community-based organizations (CBOs) of effective~     programs for reducing the spread of HIV and other sexually transmitted infections (STIs).~     Taking a brief, single-session counseling program (called Mujer Segura) that has been~     proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities~     along the U.S. border, this project will study the implementation of the program in CBOs in~     12 additional cities throughout Mexico to determine how best to ensure that the program~     remains true to the original model and retains its effectiveness. Mexico has been chosen~     because HIV is a global problem that respects no international borders, and because HIV~     prevention programs that can be implemented in settings with limited resources are urgently~     needed in many parts of the world.~   "
121498|NCT01465594|"~     The study aims to show the technical feasibility of the suprapubic urinary diversion after~     endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the~     patients with at least the same catheter complication rate in comparison to the urethral~     urinary diversion.~   "
121499|NCT01465581|"~     The target population of this study is children with primary or secondary daytime urinary~     incontinence, who have failed to improve adequately despite compliance with at least 6~     months of standard medical therapy.~      The study hypothesis is that patients who under go cutting the filum terminale - the~     string-like lower end of the spinal cord - will have improved bladder function at 6-month~     follow up.~      Bladder function and its effects on quality of life will be measured before surgery and at~     6-month follow up.~   "
121500|NCT01465568|"~     The purpose of this study is to study the efficacy of denosumab, a new drug, in the~     treatment of osteoporosis in patients using bisphosphonates.~   "
121501|NCT01465555|"~     The specific aims of the project are to conduct a three-phase study to develop a data-driven~     Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and~     test its efficacy, as follows:~      Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that~     predicts early treatment attrition; adapt elements of a cognitive behavioral intervention~     (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence~     measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three~     monitoring assessments to inform counselors when a client is at High Risk to leave~     treatment.~      Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the~     study measures/procedures.~      Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose~     counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors~     were assigned to TAU (control condition). The primary hypothesis is that clients who~     evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts +~     CBI condition than High Risk clients in the control condition. Secondary client hypotheses~     are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment~     sessions, have more drug-free urine results, and receive more ancillary services than High~     Risk clients in the control condition.~   "
121502|NCT01465542|"~     Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP)~     toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology~     and Toxicology division in the management of APAP ingestions.~   "
121503|NCT01465529|"~     The purpose of this study is to determine the safety and local tolerability of multiple dose~     administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local,~     clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose~     is to monitor the effect of multiple dose administration of inhaled OligoG on various~     efficacy variables, such as mucolytic activity, lung function, respiratory symptoms,~     Quality-of-Life and microbiological outcome measures.~   "
121504|NCT01465516|"~     Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics~     compared to historical control. There is no difference in SVR between patients with an~     undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks~     of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable~     HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based~     therapy and 12 weeks of PR.~   "
121505|NCT01465503|"~     Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of~     the most common complication of PCI and adversely affect in-hospital, short- and long-term~     outcome.As bivalirudin proved its effectiveness in decreasing haemorrhagic events during~     PCI, its administration may be advocated in subjects deemed at high risk of~     bleeding.Objective of the present trial is to compare the safety and effectiveness of~     procedural use of bivalirudin in comparison to unfractionated heparin (UFH) in patients~     undergoing PCI deemed at high risk of procedural bleeding.~   "
121533|NCT01465126|"~     Background: Collagen IV-related nephropathies can lead to End Stage Renal Disease.~     Experimental studies have shown renin angiotensin aldosterone system blockade can reduce~     proteinuria and preserve renal function. In humans there is no proven treatment. Methods:~     This is a retrospective study of patients with Collagen IV-related nephropathies and~     proteinuria treated with enalapril analyzing the evolution of proteinuria and renal~     function, as well as predictive variables of progression to end stage renal disease. Outcome~     was creatinine clearance < 60 ml/min/1.73m2.~   "
121506|NCT01465490|"~     This is a three-staged study to develop and evaluate a monitoring instrument and associated~     intervention, as follows:~      Stage 1 - Develop and determine the reliability, validity, and sensitivity to change of a~     brief Multidimensional Monitoring Instrument (MMI) for clients in outpatient substance abuse~     treatment (SAT).~      Stage 2 - Develop a Monitoring and Feedback Intervention (MFI) that uses the MMI. As part of~     this process, create a manual, training materials, and competence and adherence measures,~     and conduct a feasibility study within an outpatient SAT unit to refine the intervention and~     associated materials and measures.~      Stage 3 - Conduct a randomized clinical trial (RCT) to determine the preliminary efficacy of~     the MFI compared to treatment as usual (TAU) for clients in outpatient SAT. In this pilot~     study, it is hypothesized that the MFI will positively impact the treatment process, and~     short-term, during treatment, outcomes.~   "
121507|NCT01465477|"~     Fibromyalgia is a clinical syndrome characterized by the presence of chronic widespread pain~     accompanied by tenderness and fatigue. Central sensitization is considered to be a major~     pathogenetic feature of fibromyalgia. While the etiology of fibromyalgia is incompletely~     understood, it is generally considered to result from the interaction between an appropriate~     genetic background and the exposure of a susceptible individual to various inciting~     triggers. These have included among others physical trauma, infection, stress etc.~      The possible role of vaccination in causing or exacerbating fibromyalgia has been previously~     raised. Thus, gulf war syndrome, an entity with considerable clinical overlap with~     fibromyalgia, has been considered to have a possible link with the exposure to multiple~     vaccinations. More recently a theory has been advanced regarding the possibility that~     vaccination - related adjuvants may induce a multisystem disorder characterized by symptoms~     such as fatigue, cognitive impairment and arthralgia (the so called ASIA syndrome).~      The investigators have previously established the safety and efficacy of influenza~     vaccination in Rheumatoid arthritis patients.~      In view of this background it is of considerable clinical importance to ascertain both the~     efficacy and safety of vaccination in patients suffering from fibromyalgia.~   "
121508|NCT01465464|"~     The purpose of this study is to compare the overall survival (OS) for Orantinib in~     combination with transcatheter arterial chemoembolization (TACE) versus placebo in~     combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).~   "
121509|NCT01465451|"~     The purpose of this study is to investigate efficacy and safety of intra-operative~     chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The~     hypothesis is intra-operative intervention might be the best timing for cancer cells killing~     by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor~     debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for~     intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU~     injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into~     portal vein system via mesentery vein after tumor removal and finish of bowel~     reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision~     closure. The controlled arm receive curative resection only. All the other treatments will~     stick to the guidelines.~   "
121510|NCT01465438|"~     Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has~     a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a~     progressive, erosive arthritis causing severe disability and increased mortality.~      The biologic treatment infliximab and etanercept have recently been introduced for treatment~     of PsA and psoriasis, and current data indicate a higher efficacy than with previously~     available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but~     preliminary data are encouraging. The improved treatment options have increased the need for~     sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the~     efficient therapies can be initiated at the optimal time point and monitored optimally.~     Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are~     promising, but not yet sufficiently studied, methods for this.~      The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel~     imaging- and biomarkers can provide additional information, compared to clinical measures~     and radiography, concerning activity, destructive progression and prediction of therapeutic~     response in PsA patients receiving adalimumab. The perspective is a potential improvement in~     diagnosis, monitoring and prognostication of patients with PsA.~   "
121511|NCT01465425|"~     The ACRIN 7151 trial will use medical records abstraction data from participants with~     extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to:~     1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures~     associated with ECFs reported on computed tomography colonography (CTC), delineated by type~     of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization,~     and interventional procedures, delineated by type of ECF; and 3) evaluate the~     clinical/pathologic diagnoses associated with indeterminate but potentially significant~     ECFs. These data can be used to incorporate ECFs into existing models on the~     cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to~     develop guidelines for the reporting and management of ECFs.~   "
121512|NCT01465412|"~     The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after~     administration of a single 5 mg oral dose of preladenant in participants with hepatic~     impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with~     participants with mild hepatic impairment. Part 2 compares healthy volunteers with~     participants with moderate hepatic impairment. Healthy volunteers in each part of this study~     are to be matched with participants with hepatic impairment by race, age, gender, and body~     mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,~     the area under the concentration-time curve from time 0 extrapolated to time of the last~     quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched~     healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within~     the interval [0.50, 2.00].~   "
121534|NCT01465113|"~     This study is being conducted to determine if vitamin D supplementation increases the level~     of a protein that may be involved in decreasing the risk of esophageal cancer in patients~     with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D~     supplementation for 2-12 weeks depending on the severity of their condition, and receive an~     upper endoscopy procedure before and after vitamin D supplementation trial.~   "
121513|NCT01465399|"~     Immediately following tooth removal, a healing process begins that affects the eventual~     alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing~     are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a~     poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring~     expensive and time-consuming reconstructive surgeries, or even the inability to be~     corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic~     potential effect to minimize the consequences of this aggression, promoting the regeneration~     of both hard and soft involved tissues.~   "
121514|NCT01465386|"~     This phase II trial studies how well bortezomib works in treating patients with high-risk~     acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth~   "
121515|NCT01465373|"~     The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment~     techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.~   "
121516|NCT01465360|"~     The purpose of this study is to assess the performance of AclarusDx™, an investigational~     blood test detecting gene expression information, and intended to help physicians in making~     an Alzheimer's Disease diagnosis in patients having memory impairments.~   "
121517|NCT01465347|"~     This open-label study will evaluate the safety and efficacy of TSC when dosed concomitantly~     with the standard of care (radiation therapy and temozolomide) for newly diagnosed~     glioblastoma in adults. All patients will receive TSC in the study. The objective of the~     study is to evaluate the effect of TSC on survival and tumor response in patients with GBM~     while establishing an acceptable patient risk profile.~   "
121518|NCT01465334|"~     The main purpose of this study is to examine how two separate groups of 17p deletion Chronic~     lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular~     combination of drugs. The two groups are those participants who have previously received~     treatment for their CLL and those who have not yet received any treatment. The combination~     of drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab~     and Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p~     CLL. We hope that by combining these drugs together in this study, they will have more~     benefit than each one alone and that the subjects' CLL will be significantly impacted.~   "
121519|NCT01465308|"~     The purpose of this study is to determine whether the use of pure honey will help in the~     treatment of radiation induced xerostomia and oral mucositis (symptom management)~   "
121520|NCT01465295|"~     The purpose of this clinical trial is to study a new method of treatment for patients who~     are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the~     spine. The treatment consists of the surgical implantation of a new medical device called~     the HemiBridge™ Clip. This medical implant device has never been used in humans.~     SpineForm, LLC, the developer of the HemiBridgeTM System has designed this scientific~     clinical trial, to evaluate the safety of the use of this device in humans. Information~     collected from patients treated with this new device shall be used to determine the initial~     safety of the new device.~      The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six)~     pediatric patients who have idiopathic scoliosis.~      This procedure is intended to stop additional curvature of the spine by redirecting growth~     of the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical~     procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each~     vertebra involved in the curvature. The HemiBridge™ Clip forms a bridge between each~     vertebra and is intended to hold the vertebrae in place to prevent the spine from curving~     any further.~   "
121521|NCT01465282|"~     The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327~     ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up~     to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.~   "
121522|NCT01465269|"~     The aim of this study is to determine the effectiveness of holistic group treatment program~     (called Group Interactive Structured Treatment, or GIST) to improve social communication~     skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative~     intervention, those receiving the GIST intervention will show improved social competence,~     improved quality of life, and stronger group cohesion.~   "
121523|NCT01465256|"~     The purpose of this study is to determine if the use of aspirin prior to colonoscopy~     increases the risk of post polypectomy bleeding. The primary end point is comparison of~     bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit~     group. The secondary end point is analysis of risk factors which affect early or delayed~     post polypectomy bleeding.~   "
121524|NCT01465243|"~     To determine whether dose escalation can provide a better survival to patients who failed~     with icotinib at routine dose.~   "
121525|NCT01465230|"~     This study will determine whether or not Lenalidomide improves effectiveness of treatment~     for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to~     treat the disease (bendamustine and rituximab).~   "
121535|NCT01465100|"~     The purpose of this research study is to determine whether partial irradiation of the liver~     and liver cell transplantation can reduce the need for dietary and medical management or~     could possibly eliminate the need for a special diet and medications to treat this disease~     for patients with phenylketonuria (PKU) by normalizing phenylalanine levels in the body.~     Phenylalanine (Phe) is a substance needed in the body that can only be obtained from the~     foods people eat. People with PKU cannot get rid of Phe in their body. Large amounts of Phe~     can cause problems, such as deterioration of mental function. At the present time, liver~     cell transplants are experimental and have been done in only a limited number of human~     subjects.~   "
121546|NCT01464957|"~     Skin cancer risk is largely determined by sun exposure during childhood. This study~     determines the effectiveness of a mailed intervention designed to increase sun protection~     for children age 6-9 years old. The intervention includes newsletters for parents that~     include risk information tailored to each child. Also included are sun protection resources~     such as a swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3~     consecutive years, and data collection includes telephone interviews and skin exams. The~     study hypothesis is that receipt of the intervention will result in improved sun protection~     of the child.~   "
121526|NCT01465217|"~     Uncontrolled high blood pressure (HBP) is a major public health concern and leading cause of~     cardiovascular disease worldwide. The HBP crisis is particularly onerous to African~     Americans as they are disproportionately more susceptible to HBP than non-Hispanic White~     Americans. Poor adherence to prescribed medication regimens is a major problem, as only~     about half of patients who have been diagnosed with hypertension adhere to prescribed~     medications. Mobile phones and text messages are becoming widely integrated into routine~     daily life and may offer a simple and non-labor intensive strategy for improving the quality~     of medication management through enhancing medication adherence. This proposed research will~     be conducted in two distinct phases addressing three specific aims. For Specific Aim 1~     (Phase I), the investigators propose to conduct focus groups with participants from the~     investigators target population in order to obtain feedback to guide the development of a~     mobile phone text message system that seeks to improve adherence to antihypertensive~     medications. For Specific Aim 2 (Phase II), the investigators propose to pilot test the~     newly developed text message intervention with a randomized controlled trial. For Specific~     Aim 3 (Phase II), the investigators propose to ascertain participant perceptions of~     intervention effectiveness and satisfaction in order to guide further system refinement. In~     Phase I, African Americans with uncontrolled hypertension (n=24-32) will be recruited to~     take part in one of four focus groups that will help guide the development of the text~     message intervention. In Phase II, African Americans with uncontrolled hypertension will be~     randomized to receive usual care (n=30) vs. the text message intervention (n=30). The~     primary outcome in this pilot will be change in medication adherence at one month follow-up;~     secondary outcomes include change in medication self-efficacy and systolic and diastolic~     blood pressure at one month follow-up, as well as participant satisfaction with the text~     message intervention. The proposed research will utilize the Wayne State University (WSU)~     Center for Urban Studies to conduct high quality and professionally run focus groups, the~     WSU Division of Computing and Information Technology's Broadcast Message Service~     infrastructure for the delivery of text messages, the WSU Center for Health Research for~     statistical analysis and grant management assistance, and a diverse study team from a~     variety of disciplinary backgrounds at WSU. As a result, the proposed research leverages the~     considerable local resources to investigate an innovative and much needed intervention for~     this high-risk population.~   "
121527|NCT01465204|"~     This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap~     (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and~     Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the~     causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor~     in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE~     will assess the impact of exposure to the HWWS and TSSM promotion on individual-level~     hygiene and sanitation practices, and on the health and welfare of children 0-5 years old.~     By introducing exogenous variation in handwashing and sanitation practices (through exposure~     to the HWWS and TSSM promotion), the IE will also answer a number of important questions~     related to the effect of the intended behavioral change (handwashing and improved~     sanitation) on health and welfare, thus providing information on the extent to which these~     behaviors alter intended development outcomes. This study uses a cluster-randomized~     experimental design, whereby the geographic units called clusters (e.g. village, commune,~     ward, depending on administrative structure of country) are randomly assigned to receive~     certain components of the Handwashing and Sanitation interventions in the case of treatment~     arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final~     sample for the evaluation will consist of approximately 14,000 households, randomly~     selected, with at least one child between 0 and 24 months of age at baseline. Data will be~     collected from these 14,000 households (approximately 54,781 subjects) through household~     surveys, anthropometric measurements, blood and stool samples, direct observations of~     behaviors, and community surveys. The data collected will be analyzed using a differences in~     differences approach, where possible, and the results will be disseminated to country~     officials and others stakeholders.~   "
121528|NCT01465191|"~     HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for~     cesarean section will be affected by the genetics of the woman's mu-opioid receptor~      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most~     receive a dose of preservative free morphine with the spinal anesthetic.~     Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose~     administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.~      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and~     opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at~     the 40th amino acid of the protein, with asparagine and asparate being present in different~     people. The less common variant (aspartate), present in 25-30% of the overall American~     population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in~     many studies to affect opioid analgesia.~      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150~     micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women~     will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other~     genes that may affect pain and analgesic responses. The primary outcome will be the amount~     of intravenous morphine patients self-administer in the 24 hours postsurgery.~      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each~     dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,~     satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.~      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for~     assessment of the dose response to morphine in the overall population; then a final analysis~     at 300 subjects for the genetic effect assessment.~   "
121529|NCT01465178|"~     It is the investigators hypothesis that the current method of evaluating vitamin D status,~     measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and~     is therefore inadequate. The investigators liken this concept to the evolution of~     cholesterol where initially, total cholesterol was the only measurement, and have since~     determined the importance of HDL, LDL and triglycerides in evaluating patient status.~     Similarly, the investigators feel measurement of other vitamin D components such as sulfated~     vitamin D, circulating vitamin D3 and 3-epi 25-hydroxy vitamin D will offer more~     comprehensive information about a patient's vitamin D status.~      It is our overarching hypothesis that a vitamin D assay panel, will enhance understanding~     of vitamin D status. It is our expectation that the enhanced understanding based on improved~     measurement capability will ultimately translate to improved definition of vitamin D status~     and need for supplementation on an individual level.~   "
121530|NCT01465165|"~     Several lines of evidence support the existence of an underlying abnormality in brain energy~     metabolism may play a key role in the biology of mood disorders. The current study utilizes~     two distinct but complementary imaging techniques, FDG PET and multinuclear MRS, to better~     understand the nature of these metabolic abnormalities in major depressive disorder (MDD).~     The investigators hypothesize that individuals with depression will have increased metabolic~     activity as measured by PET in certain brain regions involved in mood regulation, but that~     this metabolic activity will be inefficient based on MRS findings. For this study, the~     investigators will study 10 medication-free, currently depressed participants with recurrent~     MDD, 10 depressed participants with recurrent MDD currently taking antidepressant~     medication, and up to 20 healthy control participants matched to depressed participants for~     age and gender. Depressed and healthy participants will each undergo one PET scan and one~     MRS scanning session.~   "
121531|NCT01465152|"~     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of~     metformin and repaglinide used alone or combined administered as initial treatment in~     subjects with type 2 diabetes in which diet and exercise have failed.~   "
121532|NCT01465139|"~     CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune~     cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety~     and biological response for approximately one month or more.~   "
121544|NCT01464983|"~     The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000~     mg Aspirin® (study medication) by comparing it to placebo (the control group without active~     substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of~     episodic tension-type headache. The study is designed to develop a treatment method against~     episodic tension-type headache which will have more advantages for patients than the methods~     that are currently available.~   "
121536|NCT01465087|"~     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic~     and environmental factors. Different populations have different susceptibility to MS. The~     disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.~     Clinical disability is due to distraction of the central nervous system (CNS) myelin.~      Repair processes are mainly noted after the acute relapse - and recovery of function can be~     spontaneous. However, in severe relapses sometimes there is need for STEROID TREATMENT.~      For the long term prophylaxis - following the increased understanding of the disease, in the~     last 10-15 years, there are new immunotherapies available (COPAXON / TEVA; Interferon~     -beta). However these can attenuate the disease (reduce the number of relapses per year) but~     cannot cure it. Also, they are beneficial in only ~40 % of the Relapsing -Remitting~     patients.~      Currently there are no biomarkers available for MS (other than oligoclonal Immunoglobulin G~     (IgG) in the cervical spine fluid (CSF) - which helps confirm diagnosis but require an~     invasive procedure and are not correlated with disease activity nor response to therapy) and~     monitoring of MS and its treatment is by magnetic resonance Imaging (MRI) - which is an~     expensive procedure.~      Dr Hossam Haick from the Technion developed an electronic nose based on nanomaterials for~     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research~     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair~     in persons with MS can be detected by the electronic nose.~   "
121537|NCT01465074|"~     Patients with schizophrenia display cognitive impairments, such as reduced attention and~     problems with memory. Available medications for schizophrenia poorly alleviate memory~     problems however, research indicates that nicotine improves memory. In order for there to be~     memories formed, there has to be changes (neuroplasticity changes) in how the brain cells~     communicate. One way to induce such changes is by using Transcranial Magnetic Stimulation~     (TMS) combined with peripheral nerve stimulation in a Paired Associative Stimulation (PAS)~     paradigm. The investigators laboratory has developed a novel method that measures~     memory-like brain changes using electroencephalography (EEG), TMS and PAS. The present study~     will use this novel method to evaluate the effects of acute nicotine gum (4mg) and placebo~     (regular) gum on memory and memory-like brain changes in schizophrenia and healthy controls.~     The hypothesis is that nicotine will improve memory and facilitate neuroplasticity changes~     in the prefrontal cortex of patients with schizophrenia to a larger extent than in healthy~     controls.~   "
121538|NCT01465061|"~     With the rise of usage of the internet, online social networks have recently been gaining~     popularity. Joining these groups can be beneficial to patients with chronic medical illness,~     such as psoriasis.This was a cross-sectional online survey of psoriasis patients in the~     Philippines who are members of online support groups. The survey was conducted for a period~     of three months.The purpose of the research project was to describe the demographics,~     disease characteristics, activities and benefits of online support groups to Filipino~     patients with psoriasis. The extent to which members experience empowering processes and~     outcomes was also evaluated.~   "
121539|NCT01465048|"~     This is an open label, human pilot study to optimise controlled human malaria infection~     (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be~     inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to~     identify the optimal regimen that achieves the greatest infection rate in volunteers with~     Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and~     45 years. Safety and infectivity data will be collected for each of the regimens.~   "
121540|NCT01465035|"~     This is a single blinded placebo controlled phase I study, to assess the safety and~     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with~     seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.~      The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV)~     is that the immune system will be stimulated to produce both influenza specific T cells and~     influenza specific antibodies.~   "
121541|NCT01465022|"~     Objectives~      To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined~     oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth,~     contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific~     research questions:~        1. To determine whether there is a difference in rates of breastfeeding continuation at 2~          months and 4 months between postpartum breastfeeding women using progestin-only pills~          vs. combined pills.~        2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks~          between postpartum breastfeeding women using progestin-only pills vs. combined pills.~        3. To determine whether there is a difference in birth control method continuation at 2~          months and 4 months between postpartum breastfeeding women using progestin-only pills~          vs. combined pills.~      Hypothesis~      Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will~     cause a differential in continuation of breastfeeding: 35% continuation in the combined pill~     group vs. 60% in the progestin-only pill group at 8 weeks.~   "
121542|NCT01465009|"~     The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study~     medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of~     sore throat associated with a common cold. The study is designed to develop a treatment~     method against sore throat associated with a common cold which will have more advantages for~     patients than the methods that are currently available.~   "
121543|NCT01464996|"~     This randomized clinical trial evaluates the clinical performance of a new two-component~     self-etch universal adhesive, OptiBond XTR, when applied in non-carious Class V cervical~     lesions without macromechanical retention (retentive grooves or bevels). The control~     material is OptiBond FL, a traditional etch/prime/bond adhesive with documented clinical~     performance. Eighty non-carious Class V cervical lesions are divided into two groups to be~     treated with either OptiBond XTR or OptiBond FL. Both adhesives are applied strictly~     according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based~     composite, is used as the restorative material with both adhesives. The restorations will be~     evaluated at insertion (baseline), 6 months, and 18 months. An optional three-year recall~     evaluation is also proposed. The investigators hypothesize that both adhesives will have~     comparable performance.~   "
121545|NCT01464970|"~     The purpose of this study is to determine in-vivo the effects the contralateral superficial~     inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior~     epigastric perforator flaps.~   "
121547|NCT01464944|"~     This study is addressed to patients suffering from an acute febrile upper respiratory tract~     infection suspected to be of viral origin. The purpose of this study is to determine the~     antipyretic efficacy (reduction of fever by lowering the body temperature from a raised~     state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of~     Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of~     Placebo (comparator medication without an active substance). Despite of its common use for~     fever treatment, the scientific data in adults which support the antipyretic efficacy of~     Aspirin are sparse. Therefore, the purpose of this study is to collect such data.~   "
121548|NCT01464931|"~     The primary objective was to evaluate the incidence of clinically significant hypocalcemia~     following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic~     kidney disease (CKD) and CKD on dialysis~   "
121549|NCT01464918|"~     This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced~     endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon~     cancer in human.~   "
121550|NCT01464905|"~     The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with~     relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active~     comparator. The primary clinical objective selected for this Phase 3 study, the cumulative~     number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted~     lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance~     imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the~     superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®,~     respectively.~   "
121551|NCT01464892|"~     Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early,~     chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not~     been investigated within a controlled setting with patients with PTSD following early,~     chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the~     efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can~     be improved by adding a stabilization phase (Skills training in affective and interpersonal~     regulation, STAIR) prior to this treatment. In a randomized controlled trial three~     conditions will be compared:~        1. Imagery Rescripting~        2. STAIR + Imagery Rescripting~        3. Wait-list control~   "
121552|NCT01464879|"~     This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum~     testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the~     pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand~     application~   "
121553|NCT01464866|"~     This study will determine the effect of nutrition supplementation on blood protein levels in~     pediatric burn patients.~   "
121554|NCT01464853|"~     To determine whether specialized enteral nutrition support can improve oxygenation status in~     critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome~     (ARDS) comparing to a standard enteral nutritional formula.~   "
121555|NCT01464840|"~     PKAZ is a single institution study designed to evaluate the optimal dosing parameters for~     azithromycin for pre-surgical cesarean prophylaxis.~      Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal~     tissue concentrations that adequately treat microbes commonly involved in post-cesarean~     infections.~   "
121556|NCT01464827|"~     This is a study of combination direct-acting antiviral agents (DAA) with or without~     ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).~   "
121557|NCT01464814|"~     The purpose of this study is to determine the effects of the probiotic KE-99 Lactobacillus~     casei when administered with omega-3 fish oil on probiotic viability, fecal make-up and~     gastrointestinal (GI) health in healthy adults.~   "
121558|NCT01464801|"~     Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common~     in the Western world and strongly associated with obesity. No known effective treatment is~     known. From animal studies, it is known that the compound resveratrol perhaps has the~     potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a~     food supplement though the precise effects are unknown. This project focuses on the effect~     of Resveratrol on fatty liver disease. The researchers plan to investigate the effects of~     Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.~   "
121559|NCT01464788|"~     Randomized controlled clinical trial to estimate overall treatment benefit (improvement in~     disability) among stroke patients treated with rt-PA who are randomized to also receive~     either low-dose Argatroban, high-dose Argatroban or neither.~   "
121560|NCT01464775|"~     Endometriosis is a relatively common chronic gynecological condition that affects~     approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that~     is characterized by the presence of endometrial glands and stroma outside of the uterine~     cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and~     infertility; the severity of pain associated with this disease often leads to a considerable~     decrease in quality of life.~      The standard treatment for severe pelvic pain and infertility is to surgically remove~     endometriotic areas. Identifying all endometriotic lesions is paramount to optimal~     endometriosis debulking. The inability to see all endometriosis lesions has been thought to~     be a factor for patients with little or no relief following surgery. Using the Narrow Band~     Imaging (NBI) method has the potential to improve visualization of endometriosis lesions,~     assist in debulking and thus, result in improved clinical outcomes.~      NBI is a technique that uses a specific narrow wavelength of light to change the normal~     color contrasts of the endoscopic image and improve detection of neovascularization, which~     is the pathological feature of endometriosis for both superficial and deeper~     vascularization. This type of imaging has the potential to offer improved discrimination of~     lesions, increasing diagnostic yield as well as resulting in more complete debulking.~      This study is designed to determine the degree to which NBI improves the detection and~     diagnosis of endometriosis lesions. Data collected during the study will be used to test the~     hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic~     lesions at the time of laparoscopy compared to standard visible white light examination.~     Furthermore, this study will also determine the impact of the use of NBI compared to use of~     white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months~     following surgery.~      Hypotheses:~      The use of NBI in addition to white light examination will improve the diagnostic yield of~     endometriotic lesions at the time of laparoscopy compared to only using white light~     examination.~      The use of NBI in addition to white light examination will improve the sensitivity of~     detecting endometriotic lesions and reduce false positives at laparoscopy compared to only~     using white light examination.~      Secondarily, the use of NBI will be associated with a greater reduction in pain at the~     6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone~     because of improved lesion identification and debulking.~   "
121561|NCT01464762|"~     The purpose of this is a study to provide early access of TMC207 to patients with pulmonary~     infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to~     isoniazid (INH), rifampin (RMP), and to a fluoroquinolone (FQ) and/or injectable second line~     tuberculosis (TB) drug (kanamycin, amikacin, or capreomycin) and who are unable/ineligible~     to participate in any other TMC207 study. In addition, information on safety and~     tolerability of TMC207 in combination with anti-TB drugs will be assessed and the results of~     microbiology assessments which are recommended to be performed during the early access study~     will be collected.~   "
121562|NCT01464749|"~     Aims of the study:~      This is a single blind randomized-controlled trial to test the feasibility and the effects~     of a task oriented training on locomotor function, mobility and balance in multiple~     sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not~     be treated with a specific physical therapy (usual care).~      Subjects and methods:~      60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic~     (Azienda Ospedaliero-Universitaria di Ferrara).~      Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented~     training (experimental group) or usual care (control group) through a randomization~     stratification approach, according to a block randomization of 6.~      The experimental group will receive 10 task-oriented training sessions over 2 weeks (5~     sessions/week=intensive training). Three subjects with a supervisor physiotherapist will~     take part at the TOCT.~      Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy~     outcome measures will be clinical test for gait speed (10m walking test), walking endurance~     (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test);~     a structured interview for the performance(Lower Extremity Mal); self-assessment~     questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical~     and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability~     (multiple sclerosis walking scale MSWS-12).~      Outcome measures will be assessed the week before the treatment (T0), after the treatment~     (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded~     to the treatment.~   "
121563|NCT01464736|"~     On the following tests, there would be a greater increase in the functionality of COPD~     patients who underwent combined therapy than in those who only exercised: a set of~     activities of daily living (ADLs), the six-minute walk test (6MWT), an incremental~     symptom-limited cardiopulmonary test (CPT), and the physical functioning scale of the~     Short-Form 36 quality of life questionnaire (SF-36).~   "
121564|NCT01464723|"~     The purpose of the study is to investigate whether the efficacy of Lucentis treatment for~     exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA~     polymorphisms~   "
121565|NCT01464710|"~     The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and~     rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or~     GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and~     with either early AMD or advanced AMD in the non-study eye.~   "
121566|NCT01464697|"~     The purpose of this study is to test whether a oral micronized progesterone reduces the~     Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats~     in perimenopausal women. Oral micronized progesterone is molecularly identical to human~     progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial~     cancer in women taking estrogen in menopause. This research study will test whether~     progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether~     progesterone improves sleep disturbances and anxiety.~   "
121567|NCT01464684|"~     Investigators will characterize the body composition and metabolism of infants born from~     lean, overweight or obese mothers from whom they had previously obtained a placenta and/or~     cord blood as part of the earlier placenta and cord blood study (#111576)~   "
121568|NCT01464671|"~     The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin)~     versus unfractionated heparin (UFH) in patients presenting with stable angina or silent~     ischemia (positive stress test without chest pain) that undergo percutaneous coronary~     intervention (PCI).~      The primary endpoint of the study will be major and minor bleeding events, defined by the~     REPLACE-2 trial definition, during the index hospitalization and up to 30 days post~     discharge.~   "
121569|NCT01464658|"~     Patients with morbid obesity often develop a significant overhanging abdominal pannus.~     Problems associated with an overhanging pannus can include difficulty performing routine~     daily activities as well as exercise due to the cumbersome nature of the excess tissue. In~     addition, the abdominal pannus tissue often becomes infected due to difficulty with hygiene~     and abnormal circulation and lymphatic flow. There may also be a significant contribution~     from the pannus to the patient's underlying cardiopulmonary status which is often~     compromised in morbid obesity patients.~      In addition to weight loss, one of the treatment strategies includes a panniculectomy. A~     panniculectomy involves resection of the excess abdominal skin and fat in a wedge shape from~     the lower abdomen. Purported benefits include increased ability to exercise, better quality~     of life and improved cardiopulmonary function. However, there is a significant morbidity~     associated with panniculectomy surgery, with wound related complications occurring in as~     much as 50% of patients with this procedure.~      The investigators hypothesize that the panniculectomy procedure provides long term benefits~     to this patient population despite significant short term morbidity.~   "
121570|NCT01464645|"~     The purpose of this study is to examine the short term efficacy of the MRH system as well as~     determine if operating room time is decreased using this simple, two-tray system.~   "
121571|NCT01464632|"~     The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr)~     cumulative revision rates of the EPIK™ Uni-compartmental Knee System.~   "
121572|NCT01464619|"~     The main objective of this study is to adapt a parenting intervention for caregivers of~     young children who report depressive symptoms in primary care pediatric practices. In~     addition, the study will explore the acceptability and feasibility of a validated parenting~     program.~   "
121573|NCT01464606|"~     Pleuropulmonary Blastoma (PPB) is very rare and there is no established standard or best~     therapy. For many years, children with PPB around the world have been treated according to~     decisions made case-by-case in many different hospitals by many different physicians. No~     treatment has been tested in a large group of PPB patients.~      The goal is to treat many children with one treatment program and to learn the results of~     the treatment.~   "
121574|NCT01464593|"~     The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally~     sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of~     hepatic colorectal liver metastases (CRLM).~   "
121782|NCT01461824|"~     The investigators are doing this study to look at how different doses of the Depot~     medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in~     teens. The investigators hope that what the investigators learn from this study will be used~     to develop ways to keep girls from gaining weight or losing bone density when receiving~     DMPA.~   "
121575|NCT01464567|"~     Weaning of mechanical ventilation (MV) is an essential part in management of patients with~     Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be~     used has not been established.~      Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation~     with SBT through T tube in weaning of MV in patients with COPD.~      Design: Randomized Clinical Trial. Methods: This study will include patients with COPD,~     admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV~     for at least 48 hours. When considered by the care team ready for SBT, they will be~     randomized to one of the following strategies: SBT in Pressure Support or SBT through T~     Tube. The primary endpoint of this study will be the reduction in the days spent on MV.~     Other outcomes measured will be mortality, extubation and success rate, time to weaning of~     MV, length of ICU stay and incidence of tracheostomy.~   "
121576|NCT01464554|"~     Youth involved in the juvenile justice system have multiple problems, including an earlier~     onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in~     the general population. This 4.5 year study will develop and evaluate a new group~     intervention for youth who have committed a first time alcohol or drug offense. Teens will~     be randomized to receive either usual care or the new group intervention. Teens will~     complete a baseline, post-test (when they complete the intervention, which could vary for~     each teen but is typically around 6-8 weeks), and a 3-month follow-up survey upon completion~     of the intervention. The investigators will examine outcomes for a variety of behaviors,~     including alcohol and drug use and assess whether there are differences between the teens~     who received usual care and the teens who received the new group intervention.~   "
121577|NCT01464541|"~     Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to~     the actual orbital fracture size intraoperatively in patients who needed surgical~     intervention to correct the fracture.~      Hypothesis: there is difference between the CT measure fracture size and the actual~     intraoperative size.~   "
121578|NCT01464528|"~     Operations in the uterus are currently possible using a hysteroscope. One serious though~     rare complication of such procedures is the development of intra-uterine adhesions. There~     currently are no methods to prevent this. The aim of this study is to evaluate the safety of~     using hyaluronic gel after hysteroscopic surgery.~   "
121579|NCT01464515|"~     This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation~     (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild~     Cognitive impairment). The hypothesis of the study is that high frequency treatment with~     deep TMS will improve the daily functioning of patients who suffers from MCI.~   "
121580|NCT01464502|"~     Heart failure patients may benefit from having a special pacemaker implanted that can make~     the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy~     (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in~     optimal positions. Only two thirds of people respond to CRT and this may be because of~     non-ideal pacing wire position. A potential marker for response is the change in heart pump~     pressure change over time. The aim of this study is to use a specialised wire in the main~     pumping chamber of the heart to record the pressure changes with the pacing lead in various~     positions to determine the optimal position. It is postulated that the improved pressure~     changes will increase the proportion of responders.~      Pilot study work has shown that the work is technically feasible and safe. The initial data~     has been published in a highly regarded scientific journal. This main study will be a~     multicentre randomised controlled trial whereby patients will be randomised to either~     standard treatment or pressure wireguided treatment. The patients in the pressurewire guided~     arm will have a specialised wire implanted into the main pumping chamber of their heart via~     a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This~     will measure acute pressure changes over time and the pacing lead will be positioned in the~     site that gives the greatest change in pressure.~      If the patients in the pressurewire guided arm fare better than those receiving standard~     treatment it may alter how a large proportion of heart failure patients are treated around~     the world. The study requires 282 patients and is likely to take two years to complete.~   "
121581|NCT01464489|"~     The investigators hypothesized that increasing the cardiac output by use of atropine in~     children might result in a reduction of the intubation time needed to facilitate tracheal~     intubation.~   "
121582|NCT01464476|"~     This study will evaluate the efficacy and safety of Azimilide on the incidence of~     cardiovascular hospitalizations, cardiovascular emergency department visits or~     cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)~   "
121583|NCT01464463|"~     The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy~     (CBT) combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive~     Behavioral Analysis System of Psychotherapy' (CBASP) on psychometric and immunological~     measures in patients with major depression.~   "
121584|NCT01464450|"~     The primary objective of this study is to learn about the relative bioavailability (the~     extent to which the drug becomes available to the body) and pharmacokinetics (blood levels)~     of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as~     a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric~     (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a~     crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The~     safety and tolerability of rivaroxaban will also be assessed.~   "
121585|NCT01464437|"~     This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel~     group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated~     with metformin for at least 3 months prior to randomization.~   "
121586|NCT01464424|"~     The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs.~     bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with~     open-angle glaucoma or ocular hypertension after 6 weeks of treatment.~   "
121587|NCT01464411|"~     The purpose of this study is to evaluate effectiveness of Dasatinib as the first line~     therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in~     Japan.~   "
121783|NCT01461811|"~     The purpose of this study was to demonstrate substantial equivalence of an investigational~     toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact~     lens when worn in a daily wear, daily disposable mode for three months.~   "
121588|NCT01464398|"~     The purpose of this study is to determine the effects of stress reduction on glucose, blood~     pressure, quality of life and overall health and well-being in overweight or obese women,~     either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction~     treatment sessions will include one or more of the following activities: breathing~     exercises, meditation, stretching exercises or health education activities.~   "
121589|NCT01464385|"~     To evaluate the sensations experienced by subjects consuming a nutritional beverage.~   "
121590|NCT01464372|"~     The purpose of this study is to collect data on the safety and efficacy of using an~     electrical field stimulation device, compared to a sham (placebo) device, to treat urinary~     urgency, urinary frequency and urge incontinence.~   "
121591|NCT01464359|"~     This trial is proposes to build on our experience and is designed to maximize early (day~     3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in~     vivo. The proposed platform will allow us the unique opportunity to compare in vivo function~     from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors~     requiring education in the recipient).~   "
121592|NCT01464346|"~     The purpose of this study is to demonstrate the performance of the Enlite Sensor over an~     entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and~     buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.~   "
121593|NCT01464333|"~     This study of Humira will be conducted to obtain information on the safety (especially~     profile of malignant tumors and serious infections) and effectiveness in patients with~     Crohn's disease who are receiving Humira for a long period of time.~   "
121594|NCT01464320|"~     To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2~     diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614~     reduces glomerular filtration rate.~   "
121595|NCT01464307|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg are effective in treating patients with increased muscle~     tension/uncontrollable muscle stiffness (spasticity) after a stroke.~   "
121596|NCT01464294|"~     Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar~     performance in clinical service to conventional ceramic CAD/CAM restorations.~   "
121597|NCT01464281|"~     A Randomized, open-label, multicenter study.~      The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA~     <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap~     with the NA for safety reasons). The subjects will be randomized into 2 groups:~      Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week~     prolonged treatment by Peginterferon alfa 2a 180µg/week.~      All the patients will be followed up for 48 weeks after discontinuation of the study~     medication.~      Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.~   "
121598|NCT01464268|"~     Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing~     progression of both keratoconus and corneal ectasia after surgery, as well as possibly~     decreasing the steepness of the cornea in these pathologies. During previous studies of the~     CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking~     in which the epithelium is not removed has been proposed to offer a number of advantages~     over traditional crosslinking including an increased safety profile by reducing the risk for~     infection as no epithelial barrier will be broken, faster visual recovery and improved~     patient comfort in the early postoperative healing period.~   "
121599|NCT01464255|"~     This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week~     crossover, daily wear regimen.~   "
121600|NCT01464242|"~     The purpose of this study is to determine whether adding pentoxifylline to treatment of~     American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of~     clinical response without diminishing safety, and to identify immune correlates of the~     healing response.~   "
121601|NCT01464229|"~     Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of~     schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological~     features seem to be very promising in treating symptoms like anger and anxiety (Fava et al.,~     1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well~     powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone~     augmentation of SSRIs among MDD outpatients in partial remission with residual anger and~     irritability is warranted at this point to evaluate its efficacy, safety and tolerability on~     residual anger, irritability and depressive symptoms.~      Main hypothesis: Adults with MDD in partial remission, who are experiencing residual~     symptoms of anger and irritability, assigned to treatment with iloperidone will demonstrate~     a significantly greater reduction in the total score of the Anger/Hostility Scale of the~     Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the~     cross-over design.~   "
121602|NCT01464216|"~     The purpose of the study is to combine and correlate data from morphological and functional~     MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor~     hypoxia with the goal being predicting of prostate cancer aggressiveness.~   "
121628|NCT01463878|"~     Primary Objective:~      To determine the effects of a diabetes specific enteral formula compared to a standard~     formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose~     and glycemic variability in a homogenous group of critically ill patients in a neurological~     ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor.~     The primary end points will be the difference between the mean blood glucose levels and the~     glucose variability between the control and intervention groups for the time period that the~     patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.~      Secondary Objectives:~      To determine the effects of the diabetes specific versus standard tube feeds on the change~     in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the~     patients ICU stay.~   "
121629|NCT01463865|"~     In this study the investigators wish to compare the effect of a selective axillary nerve~     block to placebo in patients undergoing arthroscopic shoulder surgery.~      It is the investigators hypothesis that the amount of morphine consumption in the first 4~     hours postoperatively in the intervention group will be significant lower than in the~     placebo group.~   "
121603|NCT01464203|"~     Heart disease remains the most common cause of death in the UK. Chest pain is often the~     first presenting symptom in patients with heart disease, and may be a warning signal prior~     to a heart attack or death. The diagnosis based on symptoms alone however is unreliable and~     further testing is almost always necessary.~      Rapid access chest pain clinics (RACPCs) are able to expedite the assessment of such~     patients. The principal investigation used is an exercise stress electrocardiogram (s-ECG).~     Although simple, cheap, and convenient, the s-ECG is often inaccurate; missing the diagnosis~     or falsely suggesting the diagnosis. This can happen in as many as 25% of patients,~     resulting in a delay in treatment or unnecessary further investigation.~      CT Angiography (CTA) is a novel non-invasive technique where the coronary arteries can be~     visualised by Computerised Tomography. In previous studies it shows a high degree of~     correlation with invasive angiography, with a high accuracy for the diagnosis of obstructive~     coronary artery disease. However, the technique is relatively new, and its full role is yet~     to be defined in the clinical setting of a chest pain clinic. The investigators do not at~     present have any information as to whether it is able to speed up the diagnosis, reduce the~     need for other tests, and therefore also costs.~      In this trial, the investigators aim to examine the accuracy and cost effectiveness of CTA~     in patients with suspected cardiac chest pain presenting to a chest pain clinic, when~     compared to the more established techniques like s-ECG, myocardial perfusion scanning and~     coronary angiography. The study will enable us to establish the optimal and most cost~     effective strategy for investigation of patients presenting to chest pain clinics.~   "
121604|NCT01464190|"~     This is a Phase 3, randomised, active controlled, multicentre extension study to investigate~     the long-term safety and efficacy of PA21, a phosphate binder, for control of~     hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A~     (NCT01324128), subjects have already been enrolled and have been treated with study~     medication for at least 24 weeks.~   "
121605|NCT01464177|"~     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The~     treatment comprises maximal safe resection followed by radiotherapy and chemotherapy.~     Despite appropriate management, 90% of the patients will develop relapse or progression.~     After progression, the median survival is 5.2 months (Stupp, 2009).~      The treatment of GBM relapse remains investigational. Reirradiation is an option in selected~     cases.~      The objective of this study is to compare 2 schemes of stereotactic hypofractionated~     radiotherapy in the management of recurrent GBM.~   "
121606|NCT01464164|"~     The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a~     subcutaneous injection, to stimulate production of red blood cell production. To be given~     every 28 days for up to four doses.~   "
121607|NCT01464151|"~     Both ulcerative colitis and Crohn's colitis are associated with an increased risk of~     developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients~     is well established, several studies show that the risk varies widely between patients,~     depending on the presence of risk factors. Recently, several of these risk factors were~     implemented in the updated British guidelines for surveillance which are now used to~     determine surveillance intervals in our center. The new guideline recommends stratification~     of patients in a high, medium or low risk group depending on the presence of clinical and~     endoscopic risk factors and to adjust the surveillance interval accordingly. Although these~     guidelines provide a first step towards an individualized surveillance regimen, current data~     regarding risk factors for IBD-associated CRC are solely based on retrospective studies.~     Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed~     to further optimize surveillance in the future.~      Objectives:~        1. To confirm established and identify new predictive factors for colorectal cancer in a~          prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or~          colorectal cancer will be the primary outcome.~        2. To provide evidence that mucosal healing results in a significant reduction of~          colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA~          or anti-TNF maintenance therapy.~        3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline~          and determine whether expression of these markers can predict dysplasia or colorectal~          cancer development during follow-up.~   "
121608|NCT01464138|"~     This is an open label uncontrolled study to determine the efficacy of fosmidomycin and~     clindamycin when co-administered orally over three days in the treatment of acute~     uncomplicated Plasmodium falciparum malaria in children.~      The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary~     endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.~   "
121609|NCT01464125|"~     The aim of this study is to evaluate the role of azithromycin as a possible combination~     partner for fosmidomycin to protect it from its susceptibility to recrudescent infections~     when used as monotherapy for acute Plasmodium falciparum malaria while retaining its~     excellent safety profile.~   "
121610|NCT01464112|"~     The purpose of this study is to evaluate the safety and tolerability and to establish the~     maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.~   "
121611|NCT01464099|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in~     subjects with type 1 diabetes.~   "
121612|NCT01464086|"~     The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules~     for the early detection of cancers in the population under study on cancer incidence at 3~     years.~   "
121613|NCT01464073|"~     The purpose of this study is to evaluate the efficacy of 3 of physical exercise training~     programs, with a supplementation in fruits and vegetables, on body composition. 126 women~     will be randomized into 3 groups (42 subjects per group). The first program will be~     conducted at a relatively low intensity of effort, corresponding to the maximum rate of~     lipid oxidation (LIPOXmax)measured by indirect calorimetry. The second program will be at~     60% of VO2peak and the third program will be prescribed according to the Good Practices~     physical Guidelines (30 minutes per day at a moderate intensity). All subjects will receive~     a free supplement of 5 fruits and vegetables per day during all the intervention. The~     intervention will last 5 months in total.~   "
121704|NCT01462890|"~     The purpose of this study is to determine whether the early and continuous addition of~     bevacizumab for up to 30 months to the standard chemotherapy is more effective than the~     early and continuous addition of bevacizumab for up to 15 months.~   "
121614|NCT01464060|"~     Helicobacter pylori (H. pylori) infects approximately 50% of the adult population and is~     well recognized as the main cause of gastritis, peptic ulcer disease and gastric cancer. The~     cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and~     improves dyspepsia in a significant proportion of cases, so it is cost-effective.~      Eradication therapy has changed over time. Recent meta-analyses have that the current global~     eradication rate after standard triple therapy (STT) is less than 80%. Several European~     studies have found even lower eradication rates, with 35-40% of cases resulting in treatment~     failure, probably due to increased resistance to antibiotics in many geographical areas,~     principally to clarithromycin. The usually recommended pattern in the American and European~     (Maastricht III) consensus conferences from 2007 has traditionally been triple therapy,~     composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or~     metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. However, triple therapy was~     discouraged in settings with high rates of clarithromycin resistance (15-20%) and, as such,~     new strategies in order to improve the efficacy of first-line treatments are required.~     Treatment failure increases antibiotic resistant strains, leads to a second treatment and a~     new diagnostic test to confirm eradication. Unfortunately, it remains unknown whether there~     is room for improvement in these geographical areas using clarithromycin-containing~     therapies or switching to bismuth quadruple therapy should be followed instead.~   "
121615|NCT01464047|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Sprycel® so that the regulatory authority can manage the marketing approval~     properly.~   "
121616|NCT01464034|"~     This is a dose finding pilot study to evaluate the safety and determine the maximum~     tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD)~     in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at~     the MTD to evaluate efficacy.~   "
121617|NCT01464021|"~     A post-marketing uncontrolled observational study to explore and describe the effectiveness~     of adalimumab, as prescribed according to the local product label, in patients with~     moderately to severely active rheumatoid arthritis (RA) in China.~   "
121618|NCT01464008|"~     The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many~     factors. Important patient-specific factors include, age, gender, race, body weight.~     Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally,~     important treatment-related factors include the type of interferon, dose of ribavirin and~     the duration and adherence to treatment.~      Despite the importance of patient- and virus-specific factors, the most important indicator~     of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels~     after the start of treatment.~      The on-treatment virological response can thus be used to predict the probability that a~     given patient will achieve an SVR if they remain on therapy. It can also be used to~     individualize the duration of treatment.~      In this study, treatment for patients with chronic hepatitis C was individualized on the~     basis of clinical characteristics and the on-treatment virological response. The aim was to~     investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in~     tailoring the duration of treatment and predicting SVR in Chinese patients with chronic~     hepatitis C.~   "
121619|NCT01463995|"~     This study examines the prognostic properties of immune parameters, clinical scores,~     electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction~     of functional outcome one year after treatment on a neurological intensive care unit.~   "
121620|NCT01463982|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     Oratecan in combination with capecitabine~   "
121621|NCT01463969|"~     In the present study, serum pentraxin 3 level and its relationship with insulin resistance~     were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3~     level is increased in patients with PCOS and it is positively correlated with HOMA-IR.~   "
121622|NCT01463956|"~     Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and~     boceprevir in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have~     relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a~     MELD score less than or equal to 18~   "
121623|NCT01463943|"~     The study's objective is to evaluate the efficacy and safety of two formulations for the~     prophylactic treatment of diarrhea in subjects using antibiotics.~   "
121624|NCT01463930|"~     Information provided to patients modifies their expectations with surgery. The effects of~     preoperative audiovisual information on expectations with total knee replacement (TKR) have~     not been investigated. The purposes of this study were to investigate the effectiveness of~     an educational videodisc on the modification of pre-operative patients' expectations with~     TKR and to find a biophysical profile of subjects in whom this videodisc could be most~     effective. It was hypothesized that patients receiving standard information plus additional~     medical information through audiovisual videodiscs would modify their pre-operative~     expectations more than those only receiving the standard information through medical~     interviews.~   "
121625|NCT01463917|"~     This is a comparison between Hypertonic versus isotonic solution in a double blind~     randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left~     marginal branch.~      Hypertonic solution should provide better tolerance for heart mobilization with less volume~     expansion and less drugs.~   "
121626|NCT01463904|"~     Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified~     duodenal switch. It is performed on morbid obese patients and severe T2DM patients with~     obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and~     a remission of T2DM. A lower complication rate than for duodenal switch is expected.~   "
121627|NCT01463891|"~     To investigate of the clinical safety and effectiveness of eribulin mesylate in patients~     with inoperable or recurrent breast cancer~   "
121705|NCT01462877|"~     Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk~     equivalents, whose TG level is not adequately controlled after statin monotherapy. According~     to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient~     who has insufficient improvement. The purpose of the study is to evaluate the efficacy on~     lipid control and the safety of adding fenofibrate in patients on a background of statin~     treatment.~   "
121630|NCT01463852|"~     In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are~     scheduled to initiate treatment per the recommendations of their primary oncologist, will~     receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if~     this single dose will induce rapid cell death in isolated CLL cells.~      Vincristine 2 mg will be administered to the participants intravenously over 5 minutes.~     Blood samples will be collected from an intravenous line inserted into the contralateral~     limb to that where the vincristine was given, at time zero (pre-vincristine treatment),~     immediately after vincristine administration (within 2-10 minutes upon completion of~     administration) and at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at~     a later date receive chemotherapy treatment as prescribed by their primary oncologist.~      Within 7 days of vincristine administration, participants will receive a phone call from the~     research nurse to discuss potential toxicities. At the time of the initiation of standard~     chemotherapy treatment, the Principal Investigator will also meet with the participant to~     collect information regarding adverse events.~   "
121631|NCT01463839|"~     Sleep is a vital physiological function for the maintenance of health and quality of life.~     Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect~     on adequate rest at night. The aim of the present study was to determine associations~     between quality of sleep and harmful oral habits among children aged three to six years.~     Fifty children from a private school in São Paulo (Brazil) were evaluated using two~     questionnaires on sleep quality and harmful oral habits. The data were submitted to~     descriptive analysis. The chi-square test was employed for the categorical variables and~     analysis of variance (ANOVA) was carried out to compare mean values. The Student's t-test~     was used for all analyses, with the significance level set at 5%. The SPSS 12.0 program for~     Windows was used to analyze the results.~   "
121632|NCT01463826|"~     The aim of the present study are to determine whether there is an association between~     respiratory problems and dental caries in children who exhibit the habit of bruxism.~   "
121633|NCT01463813|"~     The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year~     supplementation study of the benefits and risks of vitamin D in the primary prevention of~     cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or~     older.~      [Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is~     approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations]~      The participants will be randomized to 3 groups with 6000 in each, with daily~     supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of~     vitamin D3, or 3) placebo.~      [Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects~     per group.]~      Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD~     and cancer risk factors will be assessed by questionnaires. Blood samples will be collected~     for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future~     ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record~     linkage from the national computerized hospitalization registry.~   "
121634|NCT01463800|"~     Exercise intolerance is a major burden for patients with complex congenital heart disease~     (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing~     provides a reliable tool both for assessing exercise capacity of CHD patients and for risk~     stratification and is becoming part of the routine clinical assessment of these patients.~     Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise~     training has been widely studied in chronic heart failure, its efficacy in adults with CHD~     remain unknown. The investigators hypothesize that structured exercise training will improve~     exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study~     is to evaluate the impact of structured exercise training on exercise intolerance in~     patients with complex CHD.~   "
121635|NCT01463787|"~     Varicocele is the most common surgical disease which could lead to male infertility. It is~     found in approximately 15% adult males, and in about 40% infertile males. And the incidence~     is up to 80% in secondary infertility. In the past, there was continuous controversy over~     whether a varicocele repair could improve fertility. But at present, researches are coming~     to a consensus on the indication of varicocelectomy. Several researches manifest that the~     microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and~     lowest complications rate after surgery. Microsurgical varicocelectomy includes two~     approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There~     are few studies which make direct comparison between the two methods in microsurgical~     varicocelectomy, especially in China. Operators have made decisions on the basis of their~     own experience and skills. In this study, the investigators compare the postoperative~     spontaneous pregnancy and complications rates in two approaches in microsurgical~     varicocelectomy for Chinese infertile men in their hospital.~   "
121636|NCT01463774|"~     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination~     tablet of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
121637|NCT01463761|"~     Sports training aims to enhance an athlete's performance (overcompensation). To do that, the~     athlete must go through periods of fatigue and lower performance (overreaching). When the~     training plan is balanced, this fatigue is short and reversible.If the training load is too~     heavy or if recuperation periods are too short, it can lead to persistence fatigue that may~     only be reversible in the long term. This state of fatigue is part of the broader clinical~     picture of overtraining, which includes stark changes in performance as well as mood and~     sleep disorders. Many prediction and characterization methods based on biological markers~     have been evaluated, but they have not been put into practice in sports training due to~     obstacles such as reliability, interindividual variability and high costs. This study aims~     to evaluate a new approach based on the variability of an individual's heart rate (RR~     variability), which is a way of measuring autonomic nervous system (ASN) activity. It is~     non-invasive, low-cost, and has already proven useful in athlete health monitoring.~   "
121806|NCT01461512|"~     Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed~     protective effects during prolonged ischemia in animal studies. Functional blood oxygen~     level dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1~     induction during short-time ischemia in skeletal muscle of healthy subjects.~   "
121638|NCT01463748|"~     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes~     of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther~     on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with~     metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the~     inclusion criteria of MS are according to the Bureau of Health Promotion, Department of~     Health in Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and~     Graptopetalum paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of~     this study could provide the information of Graptopetalum paraguayense E. Walther~     supplements to what has been know in MS subjects.~   "
121639|NCT01463735|"~     Acanthocytes, also termed spur cell, are large erythrocytes covered with spike-like~     projections which are associated with severe hemolytic anemia. In advanced cirrhosis,~     acanthocytes may account for 20 to 30% of red blood cells. Up to 70% of cirrhotic patients~     display anemia and hemoglobin level may fall to below 5 gr/L in spur cell anemia. The true~     incidence of spur cells in cirrhosis is not known precisely but may avoisinate 45%,~     typically in patients with advanced cirrhosis.The presence of spur cells usually predicts~     lower survival rates. Vitamin E is an antioxidant compound that is a component of biological~     membrane that helps to maintain integrity of lipid bilayers. Vitamin E deficiency leads to~     erythrocyte hemolysis, which is improved by supplemental vitamin E. This study is an open~     label single arm phase II study in cirrhotic patients treated for 4 weeks with Tocofersolan~     (Vedrop), a water-soluble derivative of alpha-tocopherol, and thus an orally bio-available~     source of vitamin E. The aim of this study is to determine the effect of tocofersolan on red~     blood cell membranes lipid composition in adult patients with cirrhosis and vitamin E~     deficiency. Secondary endpoints are the effects of tocofersolan on anemia, hemolysis and~     acanthocytosis; on lipid peroxidation and oxidative stress; the safety of a 4 week treatment~     of 700 mg/day.~   "
121640|NCT01463722|"~     The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body~     Counting for Evaluating of Fetal Lung Maturity.~   "
121641|NCT01463709|"~     Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed~     electric fields (nsPEF)~   "
121642|NCT01463696|"~     This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and~     its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the~     study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD).~     In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD)~     established; the effect of MK-8242 on liposarcoma and other tumor types will also be~     evaluated.~   "
121643|NCT01463683|"~     This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II~     compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.~   "
121644|NCT01463670|"~     The purpose of this study is to determine whether this disease will get better if treated~     with higher doses of Lenalidomide even if the disease returns while taking low doses of~     Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the~     disease will return. However, the physician currently does not know if the disease would~     respond to treatment with higher doses of Lenalidomide. This is very important for patients~     with multiple myeloma because the number of drugs available to treat the disease are~     limited. It is important to know if Lenalidomide remains still effective and if it can still~     be used in this situation. This study will try to find out what effects, good and/or bad~     higher doses of Lenalidomide has on the patient and the disease after it has returned.~   "
121645|NCT01463657|"~     Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will~     be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial~     fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.~   "
121646|NCT01463644|"~     Some patients with chronic obstructive pulmonary diseases (COPD) have large number of~     specific white blood cells called eosinophils in their airways. These cells are also~     responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often~     cause irreversible damage to the airways . This subset of COPD patients often require oral~     steroids to bring down the number of eosinophils in their airways. Steroids have harmful~     effects on several of our body systems like bones, blood pressure, blood glucose control and~     can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils~     reducing the number in the airway. This drug has been shown to be effective in decreasing~     exacerbation rates and time to exacerbation in asthma patients with eosinophils in their~     airways. Targeting eosinophils in COPD patients has been shown to reduce severe~     exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will~     benefit similarly and have reduced rates and time to exacerbation.~      Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow~     obstruction (COPD) and eosinophilic bronchitis?~   "
121647|NCT01463631|"~     This study evaluates the safety and tolerability of different doses of an experimental~     treatment in participants with advanced cancer.~   "
121648|NCT01462799|"~     The hypothesis is that problem based learning (PBL) in patient education positively affects~     self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The~     investigators therefore aim to determine whether long-term follow-up in primary health care~     in patient education involving PBL affects self-care behaviour in terms of patients'~     beliefs, self-efficacy and empowerment to make lifestyle changes. The general aim is to~     evaluate if PBL in patient education after CHD affects long-term self-care in relation to~     present lifestyle goals. Another aim of the study is to perform an economic assessment of~     long term effects of life style changes reached by using PBL after en event of CHD.~   "
121649|NCT01462786|"~     The objectives of this trial are to evaluate the safety and tolerability of ATX-101~     injections and to compare the pharmacokinetic profile of ATX-101 administered into~     subcutaneous fat in the submental area and abdomen.~   "
121767|NCT01462019|"~     Inadequate care during pregnancy and postpartum are predisposing factors for the emergence~     of nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the~     breast and the appropriate techniques for breastfeeding. These measures, however, have a~     much more preventive than curative, it is not, in most cases, sufficient to power the~     closing of nipple trauma. The objective of this study was to evaluate the effectiveness of a~     phototherapy device designed specifically for the treatment of nipple trauma.~   "
121650|NCT01463605|"~     For patients who are unable to receive surgery or having local advanced esophageal cancer~     stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy~     for older patients because of their chemoradiotherapy intolerance. The whole world focused~     on targeted therapy which has strong specialties and mild toxicities. So combined targeted~     therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer.~     Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and~     safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal~     cancer. All patients receive intensity modulated radiotherapy with conventional fraction.~     Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.~   "
121651|NCT01463592|"~     Chronic HCV infection is one of the common causes of the chronic liver disease.~     Approximately 6-10% of the general public is expected to be suffering from this infection.~     In case that these patients are not treated at an appropriate time, these patients develop~     the sequelae of the chronic liver disease e.g. cirrhosis of liver, Ascites, and~     Hepatocellular carinoma. Interferon alpha 2 a or alpha 2b injections and Ribavirin~     combination is the treatment of choice for people suffering from Chronic HCV infection and~     this combination need to be administered for 6-12 months. Interferons are biological agents~     and are to be administered parenterally. Interferons are expensive and are associated with~     number of minor and major adverse effects. Ribavirin is also associated with significant~     adverse effects. These compounds cannot be considered as one of the ideal forms of the~     treatment.~      In the past, quite a few natural products have been tested to assess their hepatoprotective~     activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid),~     Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.~      Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the~     management of Thyroiditis and chronic cutaneous fungal infections. This combination of~     iodine compounds along with ascorbic acid is being used for the management of chronic~     hepatitis B & C in the central Asian states e.g. Kazakhstan etc.~      The investigators have conducted a feasibility study in which oral Iodine Compound~     {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and~     anti-viral activity and safety has been analyzed. In this study, RENESSANS containing~     regimen has been well tolerated by all the patients and has shown some antiviral activity.~      In this study the investigators will assess whether the administration of RENESSANS {oral }~     improves the antiviral activity in patients receiving standard interferon therapy.~   "
121652|NCT01463579|"~     The purpose of this study is to test if a 6-week programme of exercise improves physical~     function and health related quality of life in patients following intensive care who are~     discharged from hospital. In this study the investigators will compare the physical function~     and health related quality of life of patients who attend the programme with patients who do~     not. The 6 week exercise programme will be run by physiotherapy staff, and will mostly take~     place in a hospital gym. The investigators will measure patients' physical function,~     exercise capacity, level of breathlessness and their quality of life before and after the~     6-week programme, and 6 months later. The investigators will also interview patients to ask~     their views about the acceptability, enjoyment and satisfaction with the exercise programme.~     If this study shows that the physical function and health related quality of life are~     improved in those who took part in the exercise programme, then it will provide useful~     information which will help the development of services for patients after critical illness.~     The results will also provide information which will help us design future clinical trials~     for this patient population.~   "
121653|NCT01463566|"~     This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System~     when used in primary total knee arthroplasty. The purpose of the study is to obtain short-,~     Mid-, and long-term clinical outcomes and implant survivorship data for the Gender Solutions~     Natural Knee Flex System.~   "
121654|NCT01463553|"~     The purpose of this study is to:~        1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as~          evaluated from chest X-ray film, as the operative indications for video-assisted~          thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).~        2. Through a randomized double blind controlled trial on patients whose PSP was caused by~          lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of~          recurrence of PSP and the trauma of the operation on patients.~        3. Based on the findings, establish selection standards for the timing of surgery to treat~          PSP by VATS and establish technical specifications for performing operations on~          different types of lung bullae. The goal is to improve the diagnosis and treatment of~          PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of~          operation, shorten hospital stays and postoperative recovery time, and provide better~          services for returning to everyday life and improving the quality of life for patients.~   "
121655|NCT01463540|"~     Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well~     standardized technique. Two variants of this maneuver - the pull and the push techniques -~     are widespread worldwide. More recently different techniques, that allow the direct~     insertion of a gastrostomy tube has been described. The common characteristic shared by all~     these technique is the fact that the gastrostomy tube is inserted directly into the stomach~     (without passing through the pharynx), after the gastric and abdominal wall have been~     securely fasten together (gastropexy).~      Advantage of direct techniques are the followings:~        1. the tube can placed also in the case of an oesophageal stenosis~        2. studies suggest that the peristomal wound infection are less frequent using direct~          techniques~        3. in some variants of these techniques, a balloon type gastrostomy tube or a button can~          be placed also in the case of first positioning. Both the balloon type tube and the~          button are easy to be changed also at the bed-side.~      Drawbacks of the direct techniques are:~        1. these technique are easy, but a little more cumbersome than classic push or pull~          maneuvers~        2. operators are often not familiar with direct insertion~        3. kits suited for direct insertion are generally more costly than available kits for push~          or pull placement of gastrostomy tube.~      The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a~     balloon type gastrostomy tube or of a button and it is interesting, because it makes simple~     to perform the gastropexy.~      The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement~     of a gastrostomy tube and may reduce the incidence of peristomal wound infection.~     Furthermore if a balloon type gastrostomy tube or a button are positioned, they may be~     changed at the bed-side, without referral of the patient to the endoscopic unit or to an~     other sanitary facility.~   "
121656|NCT01463527|"~     The investigators hypothesize that the addition of capnography during moderate sedation will~     improve recognition of hypoventilation and apnea. This will lead to an increased frequency~     of staff interventions such as verbal or physical stimulation for these events in order to~     improve ventilation which will in turn lead to a reduction in the frequency of oxygen~     desaturations. If capnography proves to be effective in creating earlier detection and~     intervention for hypoventilation and apnea during moderate sedation provided by~     non-anesthesiologists, this device can be used in a variety of clinical settings to enhance~     patient safety.~   "
121723|NCT01462617|"~     The study will comprise three Parts:~      Part A will consist of two cohorts of healthy male volunteers to assess the safety,~     tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded~     safety and available PK data will be reviewed before each dose escalation.~      Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a~     repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The~     total daily dose will be the same as, or lower than, doses that are well tolerated in Part~     A.~      Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to~     assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.~   "
121657|NCT01463514|"~     To study the effect of acute pulmonary vasodilatation on cerebral tissue oxygenation (CTO)~     and cerebral blood flow (CBF) as indicator for cerebrovascular autoregulation in comparison~     to the effects of supplemental oxygen, decreased carbon dioxide by hyperventilation and~     exercise in patients with pulmonary hypertension (PH) undergoing clinically indicated right~     heart catheterisation (RHC).~      Oxygenation and hemodynamic parameters will be assessed during RHC according to standard~     procedures. Non-invasive near infrared spectroscopy (NIRS) and a nasal canula will be~     additionally applied to measure CTO, CBF and endtidal CO2 (EtCO2). All parameters will be~     obtained at rest breathing room air, during an oxygen challenge, during standardized~     hyperventilation, under vasodilatation testing and during exercise in random, single-blinded~     sequences (except for exercise and hyperventilation). Pulmonary, systemic and cerebral~     oxygenation parameters and hemodynamics will be correlated with each other and functional~     class, quality of life, exercise and cognitive assessments at the time of the RHC and after~     three month.~   "
121658|NCT01463501|"~     This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy~     (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative~     Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.~   "
121659|NCT01463488|"~     Study objectives:~        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,~          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.~        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and~          tolerability of a single intra-articular dose of SAR113945.~   "
121660|NCT01463475|"~     The objective of this protocol is to use established standard criteria and methods for the~     collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The~     hMSC collected from the donors will use to develop well-defined and reproducible cell banks.~     Standard manufacturing procedures and quality control testing methods will be used to~     characterize and evaluate the final cell product. After the cell banks are created, these~     cell products will be used in future translational or clinical research.~   "
121661|NCT01463462|"~     This is an observational, exploratory study designed to collect (record) and analyze normal~     and abnormal sound data from the human bladder during surgery using a novel sensor-based~     catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect~     changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope~     device will measure acoustic and pressure data within the bladder. The measurements will be~     used to detect any leakage from the bladder and/or changes in baseline ureteral flow by~     correlation of sound data with surgical data reported by the surgeon. These data will be~     used to develop algorithms to detect changes of baseline bladder and ureteral function. The~     algorithms will be tested in future clinical trials.~   "
121662|NCT01463449|"~     CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble~     variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition~     activating the monocyte-macrophage system. Recently sCD163 is associated with various~     inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather~     strong predictor of the development of type 2-diabetes. Only a subset of obese individuals~     develops insulin resistance, type 2-diabetes and related diseases. These healthy obese~     subjects are characterized of less adipose tissue inflammation and less insulin resistance~     as compared to unhealthy obese individuals. Consequently it would be of great importance to~     develop markers that could discriminate between healthy and unhealthy obese subjects. Aim:~     To investigate whether macrophage CD163 is involved in adipose tissue inflammation in~     obesity and thereby to the metabolic complications of metabolic syndrome. To investigate how~     sCD163 is regulated by metabolic factors such as obesity, fat distribution, weight loss and~     diet. Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass.~     Blood samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12~     month after surgery. Correlations studies: to investigate the influence of diet and weight~     loss on CD163 and sCD163. Perspective: To study the role of macrophages infiltration and~     activation for adipose tissue inflammation and to determine whether the macrophage marker,~     s-CD163, together with other markers will be able better to identify obese individuals who~     are at increased risk for developing complications such as diabetes~   "
121663|NCT01463436|"~     A randomized double blind controlled trial was conducted to evaluate the effect of daily~     supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women~     aged 47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was~     supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial~     function.~   "
121664|NCT01463423|"~     A research study using a method of treating lung cancer with focused radiation called~     Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the~     effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR~     based on tumor-specific factors.~   "
121665|NCT01463410|"~     This clinical study will demonstrate the accuracy of the chromosomal aberration and gene~     mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical~     performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug~     Administration for in vitro diagnostic use within the United States of America.~      The objective is to demonstrate the positive and negative percent agreement of each marker~     by comparing AMLProfiler results from multiple clinical participating sites with data~     generated using a laboratory developed bi-directional sequencing method generated at the~     molecular diagnostic reference lab.~      The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or~     APL specific chromosomal aberrations (specific recurrent translocations and inversions), as~     well as expression of specific genetic markers in RNA extracted from bone marrow aspirates~     of patients with Acute Myeloid Leukemia.~   "
121724|NCT01462604|"~     This is a 6-week, single arm, pilot study to test the study procedure, educational~     materials, and measurement instruments for the educational intervention in HER2~     overexpressing metastatic or advanced breast cancer patients~   "
121780|NCT01461850|"~     Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will~     be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs.~     neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point~     is the evaluation and comparison of the surgical complications of primary surgery and IDS~     and the evaluation of the progression free survival (PFS)~   "
121666|NCT01463397|"~     Primary Objective:~      To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated~     with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).~      Secondary Objectives:~        -  To compare the effects of SAR292833 with placebo on the change of neuropathic pain~          symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);~        -  To evaluate the effects of SAR292833 in comparison to placebo on the change in pain~          intensity of mechanical allodynia;~        -  To investigate the safety and tolerability of SAR292833 in comparison to placebo;~        -  To investigate the pharmacokinetics (PK) and the relationships between main efficacy~          parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in~          patients with chronic peripheral neuropathic pain.~   "
121667|NCT01463384|"~     Cognitively normal individuals, patients with Mild Cognitive Impairment (MCI) or Alzheimer's~     Disease (AD) will undergo clinical screening, neuropsychological tests, blood and urine~     analyses, quantitative magnetic resonance imaging (MRI) and proton (1H ) and carbon 13 (13C)~     magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral~     administration for 4 weeks initially, after which MRI, MRS and neuropsychological results~     will be recorded. If no adverse side effects occur, subjects will continue minocycline~     administration for an additional 5 months.~   "
121668|NCT01463371|"~     The mechanism by which macrolide antibiotics have immune modifying effects independent from~     its antibacterial activity has not been well established. In the present work, the~     investigators will analyze the effect of long-term treatment with azithromycin (250 mg three~     times per week during three months) on airway oxidative stress markers in exhaled breath~     condensate of adult patients with stable non-CF bronchiectasis.~   "
121669|NCT01463358|"~     Study Objective~      The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to~     patient symptoms in patients with bifascicular block and syncope of unexplained origin.~   "
121670|NCT01463345|"~     The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based~     transfusion triggers in patients post cardiac surgery.~   "
121671|NCT01463332|"~     Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10~     mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used~     for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain~     probably results from a direct irritant effect. Several methods have been used to reduce~     this pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced~     pain, but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2~     adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit~     norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could~     attenuate the pain due to injection of propofol. Investigators conducted a study to~     determine the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.~   "
121672|NCT01463319|"~     Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no~     incidence of drug-related side effects. May be slightly painful or discomforting for the~     patient. Based on numerous recent reports, the investigators designed this randomized~     controlled trial hypothesizing that the use of warm water irrigation versus air insufflation~     during the insertion phase of colonoscopy might increase the global tolerability of the~     examination and the proportion of patients undergoing complete colonoscopy without sedation~     or with a low dose of sedatives.~   "
121673|NCT01463306|"~     Study A0081106 is a 12-month open-label study to evaluate the long term safety and~     tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of~     age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with~     primary generalized tonic-clonic seizures. Pregabalin will be administered in equally~     divided daily doses for 1 year, in either capsule or liquid oral formulation.~   "
121674|NCT01463293|"~     This study will investigate the effects of 4-week probiotic supplementation on whole gut~     transit time and gastrointestinal symptoms in adults with functional constipation.~   "
121675|NCT01463280|"~     The purpose of this study is to evaluate the effect of lidocaine, delivered into~     subcutaneous tissue for tumescent local anesthesia, on platelet activation following the~     tumescent liposuction.~   "
121676|NCT01463267|"~     This study is being done to look at how people manage their heart failure. The investigators~     are testing two medication reminder systems and the investigators want to know which one~     people like better. The investigators also want to see if they have any effect on ease of~     managing medication in individuals with heart failure.~   "
121677|NCT01463254|"~     This will be a non-comparative prospective observational study of women using Femplant as a~     primary method of contraception in Pakistan.~   "
121678|NCT01463241|"~     The overall objective of the project is to develop and assess the feasibility of a brief,~     practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective~     Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice~     by practitioners in clinical service settings.~   "
121679|NCT01463228|"~     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination~     (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
121680|NCT01463215|"~     Ambroxol is expected to improve the signs and symptoms of patients with Type I Gaucher~     Disease.~   "
121681|NCT01463202|"~     The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after~     delivery to find out whether the timing of postpartum administration of DMPA (prior to~     hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of~     breastfeeding among women who plan to breastfeed their infants.~   "
121682|NCT01463189|"~     Development of an interactive, online pain self-management program for adults who suffer~     from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and~     other arthritic conditions (e.g., psoriatic arthritis) using principles from Social~     Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis,~     will provide clinically reliable information about diagnosis, treatment, and management of~     arthritis, written for health consumers in a clear and engaging manner to help increase~     their skills and confidence to use self-management strategies.~   "
121683|NCT01463176|"~     Many young children undergo medical procedures that are painful and distressing. Negative~     experiences during medical procedures can have serious long-term effects, including fear and~     avoidance of medical procedures during adulthood. Distraction interventions can help prevent~     children from forming negative memories of medical procedures. Live music therapy has been~     shown to alleviate pediatric distress during both invasive and non-invasive procedures. The~     objective of this study is to examine the effects of music therapy on the child's distress~     behaviors and time to calm, as well as the length of the procedure and use of restraint, and~     parents' and healthcare staffs' behaviors during the procedure, for young children~     undergoing immunizations and influenza vaccinations. It is hypothesized that children~     receiving music therapy will show fewer distress behaviors, calm more quickly, and have~     shorter procedures with fewer instances of restraint compared to children who receive~     standard care. In addition, it is predicted that adults (parents and staff) will show fewer~     distress-promoting behaviors during, before, and after the procedures.~   "
121684|NCT01463163|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic~     study with a parallel design. Patients with ST elevation myocardial infarction, undergoing~     primary percutaneous coronary intervention will be randomized after informed consent, in a~     1:1 ratio to the following treatment groups:~      Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose~     (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel~     60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after~     randomization).~      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6,~     24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events~     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and~     serious adverse events (bleeding, other adverse events)will be performed until Day 5.~   "
121685|NCT01463150|"~     The use of dual antiplatelet therapy is considered standard of care in patients post~     percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of~     patients is considered clopidogrel resistant and this resistance is shown to be accompanied~     by future adverse events. The aim of the study is to define in consecutive patients with~     acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with~     high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24~     hours post PCI with the VerifyNow assay. Those patients will be randomized after informed~     concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity~     will be assessed at day 15 and then treatment crossover will be performed. At day 30~     platelet reactivity will be determined as well.~   "
121686|NCT01463137|"~     A study investigating six different versions of a computerized attention bias modification~     internet program in the treatment of social phobia / social anxiety disorder.~   "
121687|NCT01463124|"~     Adolescent overweight and obesity have increased dramatically in the past several decades.~     High schools are well-positioned to deliver weight loss treatment to overweight and obese~     adolescents, as they have the facilities and staff to deliver a physical activity program,~     school nurses with the skills to provide counseling, and are easily accessible by~     adolescents. This exploratory study will test the feasibility and ability of a school-based~     intervention, consisting of school nurse counseling and a school-based exercise program, to~     reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in~     overweight and obese adolescents. If effective, this could prove to be a cost-effective and~     relatively easy intervention to disseminate widely for significant public health impact.~   "
121688|NCT01463111|"~     Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for~     the treatment of their illness will participate in this study. The study aims to evaluate~     how decision-making is affected by treatment for bipolar disorder. Prior to beginning~     treatment, patients will complete questionnaires and a one-hour computer-administered~     assessment of decision-making. Differences between pre-post decision-making outcomes will be~     evaluated to examine whether the neuroeconomic concepts of risk aversion, loss aversion,~     risk tolerance and delay discounting are affected by treatment.~      The overall goal of this study will be to identify whether decision-making in people with~     bipolar disorder is affected by treatment. Specifically the investigators will compare~     decision-making characteristics among bipolar patients prior to treatment with how these~     decision-making characteristics change over the course of 6 weeks of standard medication~     therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will~     be administered via computer to eligible subjects. The investigators will evaluate~     decision-making under varying conditions of reward, risk, and uncertainty and over time. The~     investigators hypothesize that decision-making will improve across these assessments after 6~     weeks of treatment.~   "
121689|NCT01463098|"~     Part A: The purpose of this study is to evaluate the safety and tolerability of single oral~     doses of E2006 administered in the morning to healthy male and female subjects.~      Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters~     (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects~     with primary insomnia following single oral dosing of E2006 in the evening approximately 30~     minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.~   "
121690|NCT01463085|"~     The purpose of this study is to determine if increased consumption of low-fat dairy can~     reduce blood pressure and improve endothelial function in men and women with pre or stage-1~     hypertension.~   "
121691|NCT01463072|"~     This phase II trial studies the side effects of paclitaxel albumin-stabilized nanoparticle~     formulation in treating older patients with breast cancer that has spread from where it~     started to nearby tissue or lymph nodes (locally advanced) or other places in the body~     (metastatic). Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing, or by stopping them from spreading.~   "
121692|NCT01463059|"~     The primary objective of this study is to evaluate the efficacy and safety of CDP6038~     administered subcutaneous (sc) at various doses compared to placebo.~   "
121693|NCT01463046|"~     The purpose of this study is to see if Panobinostat is safe to give to patients and to~     determine the best dose to give in combination with standard cytarabine and daunorubicin~     chemotherapy.~   "
121694|NCT01463033|"~     Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at~     preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful.~     Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of~     epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a~     strong candidate for a clinical trial of epilepsy prevention following traumatic brain~     injury (TBI). However, there has been no experience in administering levetiracetam rapidly~     to individuals with acute TBI. The investigators propose to initiate the evaluation of~     levetiracetam in prevention of post-traumatic epilepsy by determining the safety,~     tolerability, pharmacokinetics and feasibility of acute and chronic administration of~     levetiracetam to individuals with head injury with a high risk for developing post-traumatic~     epilepsy. Further, the investigators will follow subjects for 2 years after injury in order~     to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first~     step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.~   "
121695|NCT01463020|"~     The objective is to test the effects of a smartphone-delivered behavioural activation~     treatment. Also, a moderator analysis of low and high severity of depressive symptoms will~     be made. We expect the behavioural activation intervention to be superior to the mindfulness~     intervention for the participants suffering from high severity of depressive symptoms - and~     the mindfulness intervention to be better or at least as good as the behavioural activation~     intervention for the participants suffering from low severity of depressive symptoms.~   "
121696|NCT01463007|"~     The purpose of this study is to evaluate the rate of early and intermediate toxicity related~     to the AccuBoost System for delivery of APBI in women with resected, early stage breast~     cancer.~   "
121697|NCT01462994|"~     Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA~     sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly~     specific for the tumor and are released by the tumor into the circulation. Allele-specific~     PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.~      The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA~     can be detected and quantified in the plasma of patients with active GIST, and whether~     detection can be correlated with the clinical course of disease either under therapy or in~     progressive disease irrespective of current therapy.~   "
121698|NCT01462981|"~     Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus~     (HBV). Infection can result in an inflammation of the liver parenchyma with various clinical~     manifestations ranging from an asymptomatic course to jaundice. After contact with the virus~     the immunological response of the host determines the clinical outcome leading to either~     viral clearance or a chronic infection.~      Although several factors are responsible for the development of chronic HBV-infection, one~     of the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic~     hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and~     cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing~     T helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic~     patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to~     liver failure.~      Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral~     load is a strong predictor for the development of cirrhosis, independent of hepatitis B e-~     antigen status and serum alanine transaminase level. It is unclear whether these results can~     be extrapolated to non-Asian (Caucasian and African) populations because of differences in~     host (HLA background) and viral (HBV genotype) factors.~      The aim of this study is to elucidate the question whether historic HBV viral load is~     associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian~     individuals with chronic hepatitis B infection.~   "
121699|NCT01462968|"~     The purpose of this study is to find the heparinization method, which~        1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis~        2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared~          to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac~          surgery.~      The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than~     in the Hepcon-group because of the heparinization-method. Therefore there is a potential~     higher risk for use of bloodproducts postoperatively.~   "
121700|NCT01462942|"~     The objective is to provide data supporting the use of LAS40464 as an efficacious and safe~     maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease~     (COPD).~   "
121701|NCT01462929|"~     The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled~     aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide,~     respectively, after 6 weeks of treatment.~   "
121702|NCT01462916|"~     Based on the assumption that honey may have an immunomodulatory effect, the aim of our~     present study will be to verify whether the intake of honey, as a natural substance, in~     patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and~     hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be~     recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,~     Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated~     thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence~     of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is~     defined as ITP for at least 12 months. The age of the patients will range from 5 to 15~     years, and they will be of both sexes. This study was approved by the local Ethics Committee~     of the Pediatric Department of Ain Shams University, and an informed consent to participate~     in this study will be obtained from at least one parent of each patient. Furthermore, an~     ascent form will be obtained from each patient above 7 years of age.~   "
121703|NCT01462903|"~     Background: T cell based adoptive immunotherapy including CTL and TIL may stimulated the~     immune system and stop cancer cells from growing.~      Objective: Phase I clinical trial to investigate the toxicity and immune response of therapy~     with autologous tumor infiltrating lymphocytes as adjuvant treatment for metastatic~     nasopharyngeal carcinoma and hepatocellular carcinoma after primary operation, radiotherapy~     and chemotherapy.~      Methodology: Phase I clinical trial in patients with advanced nasopharyngeal carcinoma,~     hepatocellular carcinoma, breast cancer and other solid cancers. The investigators isolated~     lymphocytes from fresh tumor tissues, activated and expanded TILs in vitro; and infused the~     enough number (10e9 to 10e10) of TIL back patients.~   "
121706|NCT01462864|"~     Polycystic Ovary syndrome (PCOS) is a common hormonal imbalance affecting about 12% of women~     in the UK. The number of women with PCOS is rising. They suffer from a combination of~     symptoms including excess hair, irregular/absent periods, and infertility. About 70% of~     women with PCOS are obese or overweight, 10% develop type 2 diabetes (T2DM), and 30-40% have~     some degrees of abnormality in controlling (metabolising) blood sugar. Studies have shown~     that if women with PCOS make change to their lifestyle (diet and activity), they may reduce~     their risk of getting diabetes and heart disease in the future. This study aims to develop~     and test a programme that can be run in groups (structured education), to support women with~     PCOS make the lifestyle changes needed to improve their PCOS and prevent future associated~     health problems. Structured education programmes are suitable for use within the NHS and are~     already recommended for individuals with T2DM, but have not been tested as a method of~     treatment for PCOS which is a high risk condition for T2DM.~      The investigators aim to initially develop a specific education programme for women with~     PCOS using their expertise in their disease and defining their needs. The next step is to~     test this programme on 160 women with PCOS who will be selected from the investigators~     database or clinics. They will be divided randomly to two groups to receive either this~     programme or routine care.~      The investigators will give them an accelerometer (a very small portable device). This will~     measure their physical activity and counts their daily steps. The investigators aim is to~     increase their step count by at least 2000 steps per day after one year.~      The investigators believe that the group given the structured education will show some~     evidence of improvement in their glucose metabolism, and consequently decreased chance of~     developing diabetes.~   "
121707|NCT01462851|"~     This study is designed to observe the safety and concentrations of PF-05297909 and proteins~     in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.~   "
121708|NCT01462838|"~     Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63~     in combination with Montanide® ISA-51 VG so that an immune response directed against the~     tumor cells can be induced. The aim is to show that vaccination with P16_37-63 is safe and~     can induce or enhance immune responses against p16INK4a.~   "
121709|NCT01462825|"~     The purpose of this study is to determine the inhibiting effects of a single consumption of~     tomato ketchup on inflammation which will be induced ex-vivo in human blood.~   "
121710|NCT01462812|"~     The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through~     the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated~     with migraine headaches.~   "
121711|NCT01462773|"~     The purpose of this study is to determine the safety, tolerability and dose limiting~     toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b~     (IFN-α-2b) to patients with metastatic malignant melanoma.~   "
121712|NCT01462760|"~     In this study, the investigators will measure range of motion of the elbow in a geriatric~     assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph~     and the software analysis BioVal. This technique will be compared with the standard~     technique (inclinometer). It will also be evaluated during this study, the ease of use and~     feedback.~   "
121713|NCT01462747|"~     The aim of this study is to evaluate the effects of rectally administered activated carbon~     (medical device KULIST) in chronic, uncomplicated, perianal fistulas.~   "
121714|NCT01462734|"~     MicroRNAs are important regulators of many cellular functions but their expression profile~     in human vitreous is still unclear. Aim of this study is to investigate microRNA expression~     profile by PCR in human vitreous of macula hole patients which is suggested to be similar to~     that of healthy patients.~   "
121715|NCT01462721|"~     The purpose of this study is to evaluate patency rates of the external Saphenous Vein~     Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.~   "
121716|NCT01462708|"~     The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as~     a tool to evaluate the activity of the CB-1 receptor in the brain.~   "
121717|NCT01462695|"~     This phase II trial studies how well sunitinib malate works in treating younger patients~     with recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
121718|NCT01462682|"~     The aim of this study was to illustrate surgeons' own perception of fatigue and the impact~     they felt it had on their performance. This was accomplished through a focus group study,~     where 13 surgeons participated.~   "
121719|NCT01462669|"~     The purpose of this study is to investigate the pharmacokinetics of single oral doses of~     ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese~     volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50~     mg, 100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at~     pre-defined timepoints over the duration of the study to determine the concentration of~     ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs,~     collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity~     Rating Scale.~   "
121720|NCT01462656|"~     A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients~     within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the~     launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be~     followed until the earliest of an episode of urinary retention (UR), change in their AED~     regimen, end of follow-up, or end of study (when the specified sample size of EZG AED~     polytherapy users has been attained). After the end of study, the incidence of UR during~     exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined~     as treatment regimen containing at least two different AEDs.~      A prospective cohort study of patients who receive EZG under circumstances not indicated in~     the product label within the HIRD will also be conducted. Following the launch of EZG,~     epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients~     initiating EZG for another disease will be followed until the earliest of an episode of UR,~     change in their AED regimen (if applicable), end of follow-up, or end of study. The~     incidence of UR during exposure to EZG under circumstances not indicated in the product~     label will be described. A descriptive analysis of the patients will also be included.~      To meet the other secondary objective, non-EZG AED monotherapy users will be identified in~     the prospective cohort and incidence of UR will be calculated to determine if there is a~     difference in UR risk between monotherapy and polytherapy AED use.~   "
121721|NCT01462643|"~     The aim of the exploratory study is to compare dose related effects of LAS41004 formulations~     in a non-occlusive PPT.~   "
121722|NCT01462630|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
121725|NCT01462591|"~     Cardiovascular disease (CVD) is considered the primary cause of death in the developed~     world. Large scale epidemiological studies indicate that prevalence of hypertension along~     with adverse cardiovascular events peak during the winter months. Moreover, during the~     winter months outdoor activities and physical stressors such as exercise have been~     associated with higher cardiovascular mortality when compared to other periods of the year.~     Although low environmental temperatures have been implicated as the triggering factor for~     cardiovascular complications, the mechanisms on how cold exposure increase cardiovascular~     morbidity and mortality remain to be elucidated. However, new research suggests that cold~     exposure may induce increases in cardiac sympathetic activity, endothelial damage and~     increased arterial stiffness of central arteries. Cardiovascular drugs including~     antihypertensive pharmacological agents seem to be inefficient to provide appropriate~     therapeutic effects during cold exposure. Therefore, it is imperative to propose alternative~     non-pharmacological therapies intended to prevent the detrimental effects of low~     environmental temperatures on cardiovascular function. Recently, oral supplementation of the~     amino acid L-citrulline has been proposed as an effective therapeutic adjuvant for the~     treatment of hypertension. L-citrulline is known to enhance the bioavailability of~     L-arginine levels and increase endothelial nitric oxide (NO) production, one of the main~     modulators of vascular tone and blood pressure (BP). L-citrulline supplementation has been~     shown to increase endothelial function, reduce BP, and ameliorate endothelial oxidative~     damage without any adverse effects. Our group has demonstrated that L-citrulline~     supplementation attenuates the BP response to cold exposure (the cold pressor test, CPT).~     These studies suggest that L-citrulline supplementation may be a feasible therapeutic aid in~     order to prevent cardiovascular complications associated with cold exposure. However the~     potential cardioprotective effects of L-citrulline supplementation during cold exposure with~     exercise have yet to be evaluated. It is hypothesized that L-citrulline supplementation~     would reduce arterial stiffness and blood pressure (BP) responses to physiological stress~     (cold exposure). This study may lead to the development of an adjunct therapy for the~     prevention and management of cardiovascular adverse events that are particularly increased~     during the winter months.~   "
121726|NCT01462578|"~     Assessment of efficacy of azacitidine to prevent a relapse~   "
121727|NCT01462565|"~     The purpose of this multicentre, open label, single-arm study in approximately 20 adult~     patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of~     epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).~   "
121728|NCT01462552|"~     In July 2008, the lapatinib (Tykerb) Prescribing Information (label) was updated to include~     a boxed warning related to hepatotoxcity and detailed instructions for monitoring liver~     function before and during lapatanib exposure. For patient safety, it is of interest to know~     the extent to which providers are adherent with these guidelines for hepatic monitoring of~     lapatanib users.~      Thus, the aim of this study is to determine if physicians conduct liver function testing~     prior to prescribing lapatanib and at regular intervals during exposure, and if they~     withdraw lapatanib, and do not re-treat, for patients who demonstrate severe liver enzyme~     elevations while exposed. These aims will be tested in the Pre-label (prior to the boxed~     warning) and Post-label (after the boxed warning) periods to determine if physician~     adherence to the guidelines changed as a result of the warning.~      Specifically, the boxed warning provided the following guidance:~      Hepatotoxicity (alanine transaminase or aspartate transaminase >3 times the upper limit of~     normal and total bilirubin >1.5 times the upper limit of normal) has been observed in~     clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be~     severe and deaths have been reported. Causality of the deaths is uncertain. The~     hepatotoxicity may occur days to several months after initiation of treatment. Liver~     function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored~     before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically~     indicated. If changes in liver function are severe, therapy with lapatanib should be~     discontinued and patients should not be re-treated with lapatanib~      The following objectives will be assessed and compared among patients prescribed lapatanib~     before and after the addition of detailed guidance on liver function testing to the product~     label on July 9, 2008:~        1. Objective 1: Determine if physicians perform liver funtion tests (LFTs) prior to~          prescribing lapatanib (baseline)~        2. Objective 2: Describe the prevalence of LFT elevations at baseline~        3. Objective 3: Determine if physicians routinely perform LFTs during the duration of~          lapatanib exposure~        4. Objective 4: Describe the cumulative incidence and incidence rate of LFT elevations~          during lapatanib exposure~        5. Objective 5: Describe patients that experience severe LFT elevations during lapatanib~          exposure and calculate the proportion that have lapatanib discontinued and are not~          re-treated~      To achieve these objectives, an observational retrospective cohort study will be conducted~     using the United States Oncology Electronic Medical Records database. The study population~     will consist of females with a diagnosis of metastatic breast cancer and a documented order~     for Lapatanib from January 1, 2007 - December 31, 2009. Patients will be categorized by~     whether they initiated Lapatanib before or after the July 9, 2008 label change.~      'Pre Label': Initiated lapatanib between January 1, 2007 and December 31, 2007. Follow-up~     time for this group will continue until June 30, 2008 to allow these patients to have at~     least six months of follow-up time prior to the label change.~      'Post Label': Initiated lapatanib between July 9, 2008 and December 31, 2009. Follow-up time~     for this group will continue until June 30, 2010 to allow these patients to have at least~     six month of follow-up.~      The exposure in this study is lapatanib oral medication. The date of initiation of lapatanib~     will be the index date. Lapatanib exposure period(s) will be defined from the index date~     through to the end of the study period (June 30, 2008 for pre-label group or June 30, 2010~     for post-label group).~      The project will use proportions and two estimates of incidence (cumulative incidence and~     incidence rates using person-time) to describe the outcomes of interest among the users of~     Lapatanib before and after the label change. The following LFTs will be considered:~        -  alanine transaminase (ALT)~        -  aspartate transaminase (AST)~        -  alkaline phosphatise (ALP)~   "
121729|NCT01462539|"~     Adenotonsillectomies are one of the most common childhood surgeries and are first-line~     treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study~     comparing patients with and without OSA looking at the length of stay following~     adenotonsillectomy and the factors affecting length of stay.~   "
121730|NCT01462526|"~     Current screening methods for glaucoma detection are not perfect and nearly half of those in~     the United States with glaucoma go undiagnosed. Minority populations are even less likely to~     be diagnosed. Better screening methods are needed to identify the undiagnosed and to provide~     them care that can help them retain good vision.~      Glaucoma is often more severe in one eye and this fact can be exploited in screening tests.~     The investigators plan to use a novel screening device that very accurately records the~     pupillary response from each eye. It is likely that patients with glaucoma will have~     abnormal responses when measured, and by comparing responses between the two eyes the~     investigators will be able to determine who has glaucoma. If this test works well, it will~     provide a low-cost way to screen populations at risk for glaucoma. Furthermore, this~     research will expand the knowledge base regarding how pupil responses to light differ~     between persons with and without glaucoma. Insights gained from this study will be useful in~     the development of an effective screening tool in the detection of glaucoma.~   "
121731|NCT01462513|"~     Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival~     (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and~     saline infusion).~   "
121732|NCT01462500|"~     The purpose of this study is to determine the pharmacokinetics of miltefosine in children~     and adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with~     the parasitologic response. The results will provide pharmacologic bases to optimize the use~     of miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge~     base to assess the impact of pharmacokinetic behavior in children and adults on the~     emergence of drug resistance.~   "
121733|NCT01462487|"~     Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the~     pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved~     in the European Union (EU) through mutual recognition. It is indicated for treatment and~     prevention of influenza in adults and children over the age of 5 years.~      Zanamivir animal studies, conducted primarily in rabbits, showed a trend towards increased~     post-implantation loss, decreased fetal body weight, and increased minor fetal skeletal~     changes, although these effects were not statistically significant. Given the frequency,~     pattern and distribution of these effects, it was concluded that they were not related to~     zanamivir treatment. The summary of product characteristics for zanamivir states that it~     should not be used during pregnancy unless the potential benefit to the mother justifies the~     risk to the fetus.~      Postmarketing data have shown no higher risk of malformation with oseltamivir than in the~     general population, but data on zanamivir are scarcer. Limited data are available on~     pregnancy outcomes with maternal exposure to zanamivir during pregnancy. From 01 August 2003~     through 31 January 2009, 133 women were reported to have been treated with zanamivir while~     pregnant. Of these 133 pregnancies, 83 pregnancies were on-going or had been lost to~     follow-up (62.4%) at the time of the report; 43 resulted in a live birth with no apparent~     congenital anomalies (32.3%), 4 represented spontaneous abortions with no apparent~     congenital anomalies (3.0%), 2 were elective terminations with no apparent congenital~     anomalies (1.5%), and 1 was an ectopic pregnancy (<1%). The European Medicines Agency (EMA)~     has concluded that exposure to zanamivir during pregnancy does not represent a new safety~     risk to the fetus.~      Published research has suggested that early antiviral treatment of pregnant H1N1 patients~     can improve outcomes. In a Center for Disease Control and Prevention (CDC) surveillance~     population of 788 pregnant influenza patients with disease onset between April and August~     2009, the 384 with data on timing of antiviral treatment were observed to have significantly~     higher risk of adverse outcomes with later treatment ('intermediate', i.e. 3-4 days, n=84;~     'late', i.e. > 4 days: n=81) than with early treatment (< 2 days: n=219). Compared with~     those given early treatment, those given intermediate treatment had almost 10 times the risk~     of death, and those given late treatment, more than 50 times. Intensive Care Unit (ICU)~     admission showed more than a 2-fold risk elevation with intermediate treatment and a~     six-fold elevation with late treatment, Respective elevations in risk of need for mechanical~     ventilation were almost 4-fold and more than 12-fold. The authors noted that the reason for~     treatment delays in this population are unknown, but could include reluctance on the part of~     clinicians and patients to expose the fetus to antiviral medications, as well as use of~     rapid influenza tests, which have shown low (10%-70%) sensitivity for H1N1.~      As part of their ongoing epidemiologic safety monitoring initiatives requested by the EMA~     during the influenza pandemic of 2009-2010, GSK seeks to conduct a pregnancy safety study to~     better understand the safety of zanamivir in women exposed during pregnancy for either the~     treatment or prevention of influenza. This safety study will collect information from~     existing European databases with records of pregnant women exposed to these products and~     their pregnancy outcomes in order to assess the safety of these treatments in this~     population.~      GSK is working with PPD as the contract research organization (CRO) to oversee conduct of~     this study, including data source management and payment, study design input,~     epidemiological advice, data transfer oversight and overall project management. The CRO will~     keep a record of all relevant personnel involved in the study. Additionally, PPD has a~     strategic alliance with World Health Information Science Consultants, LLC (WHISCON)~     (www.whiscon.com), an internationally recognized organization conducting post-approval drug~     safety and risk management epidemiology. WHISCON will be providing services related to~     protocol development as well as database-specific work plans, and will assist in analysis~     and interpretation of data.~      The primary objective of this study is to evaluate the safety of zanamivir taken during~     pregnancy on 1) the outcome of the pregnancy, 2) congenital anomalies identifiable at or~     shortly after birth, and 3) treatment-emergent diagnoses in the mother occurring within 28~     days of receipt of zanamivir.~      The secondary objectives of this study are 1) to develop techniques for identifying~     influenza-like illness (ILI) in the participating data sources, and 2) to identify the~     characteristics of zanamivir recipients.~   "
121734|NCT01462474|"~     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,~     Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is~     manageable.~      PURPOSE: This phase I trial is studying the safety and tolerance of concurrent~     chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal~     carcinoma.~   "
121735|NCT01462461|"~     The purpose of this study is to determine if observing a virtual arm decreases phantom limb~     pain (PLP) in upper extremity amputees.~   "
121736|NCT01462448|"~     The purpose of this study is to determine if there is a genetic component to phantom limb~     pain. DNA will be analyzed for single nucleotide polymorphisms (SNPs) between the control~     and phantom limb pain group. Total RNA will also be isolated and profiled to asses the~     degree to which our gene(s) of interest are expressed in the presence or absence of phantom~     limb pain. Some proteins, such as inflammatory antibodies or the neurotrophin brain-derived~     neurotrophic factor (BDNF), will also be assessed for their association(s) with phantom limb~     pain.~   "
121737|NCT01462435|"~     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and~     effective for the treatment of bunionectomy pain.~   "
121738|NCT01462422|"~     This study compares two community-level strategies: selective administration of 800 mcg~     sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum~     hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for~     primary prevention of PPH. The study hypothesizes that at community-level births, secondary~     prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis~     provided to women for primary prevention of PPH. This cluster-design non-inferiority trial~     has the potential to inform service delivery programs on clinical outcomes, program~     feasibility, cost and acceptability of two different community models of PPH care using~     misoprostol.~   "
121739|NCT01462409|"~     Heated humidification in CPAP therapy is often not enough to prevent side effects like~     dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask~     leakage. Additionally a higher level of humidification in lower ambient room temperature can~     lead to condensation and irritating noises. Compliance of affected patients decreases~     considerably. Regarding this, devices with humidifier and additional heated tubing are~     developed to automatically regulate optimal humidification and temperature right up to the~     mask. The efficacy of a system with controlled heated humidification and heated tubing in~     nasal masks under various conditions like leakage and different pressure levels is object of~     this study.~   "
121937|NCT01459770|"~     Transitional care strategies focused on enhancing the accuracy and comprehensiveness of~     medication information transfer will lead to improved health outcomes among hospitalized~     patients with chronic kidney disease.~   "
121740|NCT01462396|"~     Allogeneic stem cell transplantation has been explored for patients with high risk~     neuroblastoma. Results have been mixed, with only small series and case reports. Recent~     reports, however, especially with haploidentical transplantation have been more encouraging.~     Eradication of neuroblastoma may be mediated by both components of the innate immune system~     (natural killer cells) and through the adaptive immune system via T-cell cytotoxicity and~     the development of a humoral response to tumor specific antigens and minor~     histocompatibility antigens. To overcome restrictions created by unavailability of Human~     leukocyte antigen (HLA) matched donors, stem cell grafts from haploidentical related donors~     have been explored. Historically, the use of full haplotype mismatched family member donors~     has been limited by the development of severe graft-versus-host disease and the high rate of~     graft failure. Graft failure can now be overcome by increasing immunosuppression and~     increasing the number of transplanted stem cells. The most effective means of graft versus~     host disease (GVHD) prophylaxis is T cell depletion of the donor marrow. A 3-4 log depletion~     will reduce the risk of developing significant GVHD to less than 10%. Methods to mobilize~     stem cells from the bone marrow into the peripheral blood and collect these stem cells by~     apheresis now increase the availability of stem cells by a magnitude. Selection devices have~     been developed that will prepare extremely pure populations of these CD34 cells with upwards~     of 5 logs depletion of contaminating T cells. The CliniMACS CD34 Reagent System is a medical~     device designed to select CD34+ hematopoietic cells from heterogeneous hematologic cell~     populations. The investigators intend to provide mismatched related hematopoietic stem cell~     transplantation to up to 10 patients with relapsed refractory neuroblastoma. Harnessing the~     potential for innate and adaptive immune responses through allogeneic Hematopoietic stem~     cell transplantation (HSCT) may provide cure for some patients with this tumor.~   "
121741|NCT01462383|"~     Primary Objective:~      -Evaluate incidence of cardiac complications in Phase I patients.~      Secondary Objective:~      -To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the~     detection of cardiac events.~   "
121742|NCT01462370|"~     This is a study to determine the overall analgesic effect of a single oral dose of~     etoricoxib compared to ibuprofen in participants with moderate-to-severe primary~     dysmenorrhea.~   "
121743|NCT01462357|"~     The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix~     administered according to a 2-dose schedule at 0, 6 months compared to Gardasil,~     administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule~     of 0, 2, 6 months in 9-14 years old healthy females.~   "
121744|NCT01462344|"~     The purpose of this study is to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11~     years old taking inhaled fluticasone propionate/salmeterol combination is the same as those~     taking inhaled fluticasone propionate alone.~   "
121745|NCT01462331|"~     The purpose of this study is to re-confirm the already established health effects and dose~     tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food~     ingredient.~   "
121746|NCT01462318|"~     The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield~     Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the~     pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS).~     The secondary objectives of this study are to characterize the pharmacokinetic (PK) of DAC~     HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of~     participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for~     cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).~   "
121747|NCT01462305|"~     The primary objective of this study is to evaluate the effect of light therapy using a~     narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder~     (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than~     the 580nm light.~   "
121748|NCT01462292|"~     The purpose of this study is to determine if GSK2402968 is effective in the treatment of~     ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be~     corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this~     study.~   "
121749|NCT01462279|"~     The objective of this study is to determine the effect of thiamine therapy on oxygen~     consumption in critically-ill patients. The investigators will evaluate this by measuring~     VO2 before and after thiamine administration in patients admitted to the ICU and requiring~     mechanical ventilation.~   "
121750|NCT01462266|"~     The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg~     once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus~     who have inadequate glycemic control on insulin alone or in combination with metformin. The~     primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of~     insulin relative to placebo.~   "
121751|NCT01462253|"~     This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide~     combination to treat refractory and first bone marrow relapse adult ALL, for the achievement~     of a complete remission (CR) and the concurrent evaluation of biological response in ALL~     cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).~   "
121752|NCT01462240|"~     This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used~     in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and~     long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous~     Femoral components.~   "
121753|NCT01462227|"~     Insulin treatment often causes the blood glucose levels to fall too low. The body usually~     responds to low blood glucose levels by releasing hormones which act against the insulin to~     help correct the low blood glucose levels. However, this hormone response can be altered in~     people with diabetes. Currently there are no therapeutic agents that can be used to improve~     the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people~     who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it~     can also affect the levels of the hormones which are released during hypoglycemia. The aim~     of this study is to determine whether naltrexone can be used to improve and accelerate the~     recovery from hypoglycemia in patients with type 1 diabetes.~   "
121766|NCT01462032|"~     This study is designed to evaluate two potential treatments for children with~     Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication.~     Our goal is to develop new interventions for preschoolers with ADHD that will result in~     enduring reductions of ADHD symptoms and associated impairments in children, and thus~     prevent long-term difficulties characteristic of many children with ADHD.~      Both interventions involve weekly playgroups (of roughly five children) in which children~     engage in designated activities while parents engage in groups focusing on parent education,~     support, and their children's activities. It is hypothesized that both interventions will be~     helpful, but that only one will have lasting effects well beyond the end of active~     treatment.~   "
121754|NCT01462214|"~     In the present phase 1-2 study the investigators aim to determine whether depletion of Tregs~     using metronomic cyclophosphamide can enhance the antitumor efficacy of everolimus in~     patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase~     inhibitor containing treatment regimen. In the phase 1 part of the study the investigators~     will determine the optimal CD4+CD25+ regulatory T cell-depleting dose and schedule of~     metronomic oral cyclophosphamide when given in combination with a fixed dose (10 mg daily)~     of everolimus. In the phase 2 part of the study the investigators will subsequently evaluate~     whether the number of patients who are cancer progression free at 4 months can be increased~     from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined~     in the phase 1 part) to everolimus. In addition to efficacy, the investigators will evaluate~     treatment toxicity to determine whether this combination strategy is feasible and safe.~   "
121755|NCT01462201|"~     The primary objective of this study is to evaluate the effectiveness of the Contour I VER~     3.1 System on abdominal midsection circumference reduction relative to no treatment.~      The secondary objective of this study is to assess subject satisfaction measured with a~     self-assessment questionnaire~   "
121756|NCT01462188|"~     The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely~     thrombotic lesion may determine distal embolisation of thrombotic material therefore~     deteriorating myocardial perfusion.~   "
121757|NCT01462175|"~     This multicenter, open label, dose-escalating study will evaluate the safety,~     pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD)~     or once weekly (QW) in participants with advanced malignancies except leukemia. Participants~     will receive multiple escalating oral doses in two different dosing schedules (Sch) until~     disease progression or unacceptable toxicity occurs.~   "
121758|NCT01462162|"~     This prospective observational study will investigate the effect of tocilizumab on fatigue~     in participants with moderate to severe rheumatoid arthritis who have an inadequate response~     to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs.~     Data will be collected from participants for 6 months.~   "
121759|NCT01462149|"~     Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to~     treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected~     chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic~     efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However,~     docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to~     evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients~     with advanced ovarian cancer.~   "
121760|NCT01462136|"~     The purposes of this study is to assess the relationship between renal function and~     pharmacokinetics of ACHN-490 Injection.~   "
121761|NCT01462123|"~     Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and~     pathologic data. Real-time imaging technologies, have shown promising results in~     discriminating adenomatous from non-adenomatous polyps.~      The resect and discard strategy for small polyps (based on real-time assessment of the~     histology and on the endoscopic resection without pathological examination) has been shown~     to be cost-effective in simulation models. No data exist about the impact of this strategy~     in clinical practice.~      The aim of present study was to assess whether the systematic use, in the everyday clinical~     practice, of the resect and discard strategy allows to correctly manage patients with~     small colonic polyps.~   "
121762|NCT01462097|"~     Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated~     with impairment in cognition and physical function. The purpose of this study is to test the~     effects of 12 months of aerobic and resistance exercise training compared to health~     education on cognitive and physical performance in 120 older adults with CKD not requiring~     dialysis. The results of this study will be essential for demonstrating the effectiveness of~     exercise in improving function and ultimately preventing disability in this high-risk~     population of older adults.~   "
121763|NCT01462071|"~     Background:~      A low amount of red blood cells in the blood of patients with limited kidney function is a~     well known problem. Besides the lack of substances in the blood like iron or erythropoietin~     the shortened survival of red blood cells leads to the low red blood cell count. Red blood~     cells of patients on kidney replacement therapy (dialysis) die earlier than those of healthy~     persons. They live only about 70 days compared to 120 days in healthy humans. Today little~     is known about the causes for the shorter survival of the red blood cells in patients on~     dialysis. Because inflammation leads to a shorter life of the red blood cells in people~     suffering from several diseases leading to inflammation we would like to learn about the~     role of inflammation in the shortened life of red blood cells of dialysis patients.~      When red blood cells are dying the content is broken down to several substances. One of~     these substances is the gas carbon monoxide (CO). The carbon monoxide is exhaled with the~     breath. The more red blood cells die the more CO is exhaled. That's why we can calculate the~     lifespan of the red blood cells when we measure the amount of CO in breath at the same time~     as the red blood cell count in the blood.~      Aim of the study:~      We aim to learn about the influence of inflammation of on red blood cell survival in~     dialysis patients. To look for factors with effect on inflammation or red blood cell~     survival, for example type of dialysis access, medication or kind of dialysis treatment.~      Study procedures:~      Over the course of the 18 month study, 6 observational assessments will take place. If the~     patient experiences a situation with increased inflammation during the study period (for~     example any kind of infection or intervention) up to two more study visits will take place.~     Each study visit will include blood sampling, performed without the need for an extra needle~     stick, and a breath sampling in order to calculate the red blood survival and to measure~     markers for inflammation in the blood. The breath sample will be taken using the easy to use~     GaSampler device developed by a company called Quintron especially for medical breath~     sampling.~      In order to get a sample of air at the patient's home for calculation of carbon monoxide~     produced in the body we will ask the patients to take home an open empty plastic bottle~     before each study visit. The bottle should be kept overnight on a table or sideboard in the~     apartment. Before leaving home for hemodialysis or in clinic visit the patient will seal the~     plastic bottle with the top, take it to the dialysis center and hand it to the research~     staff.~      Risks:~      The amount of the additional blood drawn is 30 ml; this is the amount 2 tablespoons, at each~     study visit. This does not harm the patient. The breath sampling does not imply any risk.~   "
121764|NCT01462058|"~     The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better~     than placebo in preventing depression symptoms among employees in health care~   "
121765|NCT01462045|"~     This study will explore the relationship between changes in plasma cortisol and symptom~     reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating~     in an 8-week program of mindfulness-based stretching and breathing exercise. The~     investigators hypothesize that at the completion of participation in the 8-week program,~     exercise-induced symptom reduction will be associated with changes in cortisol levels.~   "
121781|NCT01461837|"~     This study is being done to determine the safety and outcome (long-term control) of a~     high-dose chemotherapy regimen followed by an infusion of CD34 selected (immune cells) stem~     cells from a partially matched adult family member donor, called haploidentical stem cell~     transplantation, in high-risk sickle cell disease patients.~      Funding Source - FDA OOPD~   "
121768|NCT01462006|"~     Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in~     lung function and premature death from respiratory failure. Fibrocytes are a novel~     population of bone marrow-derived circulating progenitor cells that have been shown to~     traffic to the lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and~     whose numbers correlate with the degree of fibrosis and with survival in human pulmonary~     fibrosis. The investigators propose to test the hypothesis that therapy with the mTOR~     inhibitor, sirolimus, reduces the number of circulating fibrocytes in patients with IPF. The~     investigators propose to test this hypothesis in short-term pilot trial of sirolimus in~     patients with IPF to determine its effect on the number and phenotype of circulating~     fibrocytes.~   "
121769|NCT01461993|"~     This is a clinical study to assess the safety, tolerance and immunogenic response to~     Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects~     will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the~     injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly,~     rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are~     adolescent children between the ages of 11 and 17 years old.~   "
121770|NCT01461980|"~     This is a clinical study to assess the safety, tolerance and immunogenic response to~     MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y,~     and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086~     vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be~     randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be~     blinded to all injections given throughout the study. An unblinded administrator will be~     responsible to administer the vaccinations to all subjects and will be unblinded to the~     subject randomization in order to determine which subjects were in randomized to group 3 so~     they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact~     will be conducted with all subjects 6-months post their last vaccination to obtain safety~     information.~   "
121771|NCT01461967|"~     This randomized, double-blind, placebo-controlled, cross-over study will assess the safety,~     pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1,~     subjects will be randomized to receive single ascending doses of either RO5508887 or~     placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with~     or without food. Anticipated time on study is up to 12 weeks.~   "
121772|NCT01461954|"~     This randomized, double masked, multi-center study is being conducted to support the safety~     and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends~     to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical~     resolution of acute viral conjunctivitis.~   "
121773|NCT01461941|"~     The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment~     in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after~     topical application of E6005 is also assessed.~   "
121774|NCT01461928|"~     This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy~     and safety of subcutaneously administered rituximab in comparison with observation only as~     maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's~     lymphoma (NHL). All participants will receive induction therapy with rituximab (375~     milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg~     subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24~     months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants~     completing therapy and showing partial or complete response will be randomized to receive~     either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during~     maintenance II period and will be followed for at least 15 months. Anticipated time on study~     treatment is until disease progression, unacceptable toxicity or end of study, whichever~     occurs first.~   "
121775|NCT01461915|"~     The purpose of the study is to determine whether ODSH (2-0,3-0 desulfated heparin), a low~     anticoagulant heparin derivate with preserved anti-inflammatory and anti-neoplastic~     characteristics is efficacious in patients with metastatic pancreatic cancer with~     gemcitabine and nab-paclitaxel ( Abraxane) as first line therapy.~   "
121776|NCT01461902|"~     The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and~     brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic~     brain injury (TBI) patients who have experienced a mild to severe head injury.~   "
121777|NCT01461889|"~     Transfusion-related acute lung injury (TRALI) is the most common cause of~     transfusion-related morbidity and mortality in the United States. It is very common and~     often unrecognized in the critically ill with the greatest incidence occurring in bleeding~     patients with liver disease. Plasma is the most blood component associated with this deadly~     complication and therefore patients with liver disease who frequently receive transfused~     plasma are at increased risk. The optimal plasma transfusion strategy for bleeding patients~     with liver disease is unknown and the investigators will evaluate this clinical question in~     a small pilot randomized controlled trial. The invstigators hypothesize that targetting a~     more restrictive INR Target (2.5) vs. an INR Target (1.8) will result in less hypoxemia, a~     TRALI surrogate without increasing bleeding complications.~   "
121778|NCT01461876|"~     This is a retrospective longitudinal study that evaluates the prevalence and incidence of~     overweight/obesity within an HIV-infected population before and after 12 and 24 months of a~     stable antiretroviral therapy (ART). The study group will be compared to the weight of a~     healthy, matched population that is not infected with HIV. The primary hypothesis states~     that the proportion of HIV-infected persons newly classified as overweight/obese will~     increase by ≥20% after 12 months of initial ART, and this incidence will be greater than~     that of a matched HIV-uninfected control population. The effect of immune function~     variables, such as CD4, HIV viral load, and ART regimen on weight will be analyzed. In~     addition, the study will analyze the effect of weight and immune function markers on the~     inflammatory markers, high sensitivity C-reactive protein (hsCRP) and D-dimer. An HIV~     samples repository will be used for specimens to be assayed for hsCRP and D-dimer.~   "
121779|NCT01461863|"~     This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie~     supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health~     outcomes for HIV-infected pregnant women and their infants.~   "
121938|NCT01459757|"~     Retrospective correlation of clinical outcomes data with mutational status in GIST subjects~     treated with sunitinib.~   "
121784|NCT01461798|"~     Introduction:~      Cardiovascular diseases have become the leading cause of death from chronic diseases in the~     world. One of the major risk factors for this disease is hypercholesterolemia, caused in~     most cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active~     ingredient is plant stanol ester that competes with total cholesterol and low density~     lipoprotein or LDL cholesterol by preventing them to be absorbed by the body and reducing~     blood levels.~      Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood~     lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.~      Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in~     patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES~     control clinic in Medellin.~      Expected results: Test the effectiveness of plant stanol esters in reducing total~     cholesterol and LDL cholesterol in patients with moderate hypercholesterolemia.~   "
121785|NCT01461785|"~     In this prospective, randomized clinical trial, lipofilling of the midface with Platelet~     Rich Plasma (PRP) is compared with lipofilling of the midface without PRP. The main~     objective of this study is to investigate the effect of the addition of PRP to the~     autologous fat transfer on local skin quality improvement, graft survival, and recovery~     after the procedure.~   "
121786|NCT01461772|"~     Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment~     for patients with locally advanced cervical cancer. However, weekly cisplatin is related to~     renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good~     radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for~     both patients and physicians. Weekly carboplatin may have similar efficacy with weekly~     cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed~     to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in~     patients with locally advanced cervical cancer.~   "
121787|NCT01461759|"~     The purpose of this study is to treat advanced or recurrent endometrial cancer,~     paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by~     most physicians. Docetaxel may have similar efficacy and more favorable treatment related~     toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators~     aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with~     advanced or recurrent endometrial cancer.~   "
121788|NCT01461746|"~     Previous some studies suggested the addition of chemotherapy to radiation therapy after~     surgery may have survival benefit in patients with high risk endometrial cancer. In~     addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus~     carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may~     cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators~     aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation~     therapy after surgery in patients with high risk endometrial cancer.~   "
121789|NCT01461733|"~     Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are~     admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence~     that resolves as the patient recovers from their underlying condition. However, patients who~     develop AF can present with a very rapid heart rate that in some cases can put stress on the~     heart which can lead to life threatening heart attacks, low blood pressure or breathing~     problems. Not all patients with AF will have unstable heart function but those who have~     rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate~     but no unstable heart function are two fold. Patients can be treated by controlling the~     heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate~     can be controlled by medication and the AF can be converted by either electrical~     cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is~     unknown if the goal of treatment should be to simply control the heart rate and wait for the~     patient to spontaneously convert to a normal heart rhythm or convert the AF with medication~     for patients who only have the rapid heart rate.~      The objective of this project is to conduct a pilot study to determine if it would be~     feasible to conduct a larger definitive trial that would answer the following question:~     Should the goal of treatment be to control the rapid heart rate or resolve the abnormal~     heart rhythm in patients with AF who have a rapid heart rate without unstable heart~     function.~   "
121790|NCT01461720|"~     This study aims to determine the efficacy of intravenous transplantation of autologous bone~     marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.~   "
121791|NCT01461707|"~     Obesity among women of childbearing age and excessive weight gain during pregnancy are~     prevalent and steadily increasing health care issues. Regular physical activity is~     recommended to maintain healthy weight gain for pregnant women, however, a majority of~     pregnant women are sedentary. The investigators propose to conduct a pilot study to estimate~     the potential efficacy of a mobile phone based physical activity intervention in 30~     physically inactive pregnant women.~   "
121792|NCT01461694|"~     The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece~     with the alexandrite laser for the purposes of female facial hair reduction~   "
121793|NCT01461681|"~     Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity~     and mortality. Despite optimal management, over half of patients with HF suffer from pain,~     dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a~     huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for~     providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few~     receive it. The overall aim of this project is to conduct a randomized controlled trial~     (RCT) to determine if an interdisciplinary PC intervention (Symptom Management Service-HF~     [SMS-HF]) provided concurrently with standard cardiology care improves symptoms, QoL and~     satisfaction, and reduces resource utilization in outpatients with Class II-IV HF compared~     to standard cardiology care alone. Subjects assigned to the SMS-HF group will receive a~     6-month interdisciplinary PC intervention based on the investigators successful SMS model of~     outpatient PC for oncology patients and focused on assessment and management of physical,~     emotional, social, and spiritual distress and discussion of treatment preferences.~     Innovations of this study are that it will rigorously assess the impact of the SMS-HF on~     patient outcomes and on resource utilization, a key component to ensuring program~     sustainability. The investigators research team of PC and HF experts is recognized for its~     PC research and has a proven record of collaborating, conducting RCTs of PC interventions,~     and studying outpatients with HF. The environment at UCSF is highly supportive of innovative~     research and of sustaining programs with demonstrated improvements in patient outcomes and~     operational effectiveness. The overall goal is to use the results from this study to support~     an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models~     of concurrent PC for patients with other serious illnesses.~   "
121794|NCT01461668|"~     The investigators will conduct a randomized placebo-controlled double-blinded study of nasal~     decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among~     adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256)~     strains.~      Objectives:~        1. To determine the percent of intervention vs. control patients with successful MRSA~          nasal decolonization as determined by bilateral nares swabs following a 5-day~          twice-a-day regimen of retapamulin.~        2. To determine the time to decolonization based upon interim and final bilateral nares~          swabs.~        3. To determine the acceptability of retapamulin by surveying participants about their~          experience and adverse events experienced during this study.~      The duration of participant follow-up is expected to last up to 7 weeks.~      This study will evaluate the safety and effectiveness of Altabax (retapmulin) during~     decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level~     and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and~     there is no approved substitute topical agent for decolonization of the MRSA nasal~     reservoir.~   "
121795|NCT01461655|"~     The aim of this proof of principle study is to evaluate efficacy and safety of the~     sequential application of two marketed products for the treatment of acne vulgaris, using~     the Split-Face model~   "
121796|NCT01461642|"~     The purpose of the study is to establish and clinically evaluate a new approach to treating~     asthma by using information and communication technologies (ICT). A mobile environment, and~     organizational interventions to improve the process of an integrated treatment of people~     with asthma will be identified, developed, introduced and clinically evaluated.~   "
121797|NCT01461629|"~     The purpose of this study is to assess the relationship between cognitive impairment,~     patient self-management, health, and health service use in adults with heart failure (NYHA~     Class 2 and 3). The research questions are:~        1. How is cognitive impairment (memory, attention, global and executive function) related~          to various aspects of impaired self-management (knowledge of adherence, adherence to~          sodium restriction and medications, symptom monitoring of weight changes, and decision~          and action to seek care)?~        2. How are these relationships altered when adjusting for medical, demographic, and~          psychosocial factors?~        3. What are the relationships among degree of cognitive impairment, quality~          self-management, health status, and health service use?~   "
121798|NCT01461616|"~     The objective is to describe the interaction of equal doses of NPH insulin (Neutral~     Protamine Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth~     Factor Binding Protein-1) production as well as immunoreactive and bioactive IGF-I~     (Insulin-like Growth Factor-I) after once-daily injection on three separate visits in type 1~     diabetic subjects.~   "
121799|NCT01461603|"~     Introduction: Protein loss during critical illness is an important problem and is shown to~     predict overall survival. In animal studies, infusion of leucine is shown to increase the~     synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.~      Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral~     artery will promote protein synthesis and inhibit breakdown assessed with local a/v~     phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include~     distinct alterations in muscle signal events, in particular mTOR.~      Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv.~     femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period~     and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of~     arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain~     continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate~     solution FFa-3OHB.~      Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on~     muscle protein metabolism in humans and contribute to further development of nutritional~     therapy in human catabolic states.~   "
121800|NCT01461590|"~     Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard~     calculations, given to children with severe anaemia will be beneficial in haematological~     correction and can be given safely since respiratory distress and haemodynamic changes~     result from acidosis and compensation in these children rather than from biventricular~     failure.~   "
121801|NCT01461577|"~     Primary Objective:~        -  To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from~          baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.~      Secondary Objective:~        -  To determine the change in glycemic control, safety, and treatment satisfaction in~          insulin glargine use in patients following GLP-1 failure.~   "
121802|NCT01461564|"~     Colonoscopy is currently most effective procedure used for detecting colon cancer especially~     in the early stages. Screening colonoscopies are performed in the symptom-free patients at~     risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel~     may be retained after the procedure causing pain and discomfort to the patients. One of the~     methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead~     of air during colonoscopy.~      Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.~   "
121803|NCT01461551|"~     Most researches revealed that volatile anesthetic sevoflurane has a more marked~     cardioprotective effect against ischemia compared with intravenous agent propofol.However,~     propofol has been suggested to be more benefit for attenuation of surgery-induced~     immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB~     surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol~     and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of~     circulating lymphocytes.~   "
121804|NCT01461538|"~     This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor~     activity of brentuximab vedotin as a single agent in patients with CD30-positive~     nonlymphomatous malignancies.~   "
121805|NCT01461525|"~     Sphincter preservation surgery in low rectal cancer has been increased due to better~     understanding of tumor biology and advances in surgical technology. Furthermore, a majority~     of patients prefer sphincter preservation rather than living with permanent colostomy. But~     it is not clear whether sphincter preservation is directly related with better quality of~     life. There have been many studies comparing sphincter preservation surgery and~     abdominoperineal resection in many aspects including oncologic and functional outcomes, and~     the quality of life. However, the conclusion remains controversial because of the different~     results between studies.~   "
121807|NCT01461499|"~     The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),~     aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes~     under strict blood pressure control with angiotensin receptor blocker (ARB).~   "
121808|NCT01461486|"~     Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway~     pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this~     study is to evaluate the effect of CPAP and OA treatment on: objective and subjective~     sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and~     metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild~     OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both~     genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included.~     They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly~     distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the~     control. At baseline evaluation, six months, one year and three years, all subjects will be~     submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation,~     baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska~     Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder~     Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression,~     Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life~     questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual~     dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment~     of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.~     Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be~     used for descriptive statistical and a general linear model will be applied for analysis~     within groups on different time.~   "
121809|NCT01461473|"~     STAGE I of the COMET study is to develop an Electronic Network Informatics Infrastructure~     that will prospectively enable access to and the sharing of clinical and research data.~      STAGE II: This is a Comparative Effectiveness Trial (CET) evaluating positive airway~     pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities~     in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA).~     Data collected during the STAGE II study will be incorporated in Part 3 of the STAGE I~     study.~      STAGE III of the COMET study is completion of data analysis and preparation of the~     electronic network informatics infrastructure for use beyond the four Clinical Centers to~     interested CTSA institutions. We will also explore expanding ontologies, and the use of~     federated database methodology.~   "
121810|NCT01461460|"~     The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus~     placebo on QTcF.~   "
121811|NCT01461447|"~     The purpose of the study is to determine the safety and immunogenecity of a third MVA in the~     HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA~     vaccines.~      The investigators postulate that the Immune responses that were observed in the HIVIS 03~     trial are likely to wane over time. To date it is unknown how these responses should best be~     maintained. In this study the investigators seek to boost immune responses, especially the~     antibody responses induced by the second MVA boost.~      Since the HIV specific antibodies were induced only after the second MVA injection, it is~     hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.~   "
121812|NCT01461434|"~     Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with~     increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient~     characteristics increase the likelyhood of AF and at the same time the risk of stroke when~     AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in~     patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease).~     However, occasional (paroxysmal) AF may occur without symptoms and remain undetected,~     leaving patients at risk.~      Aim of the prospective randomized study is to compare two management strategies for patients~     at increased risk for AF but without a known history of AF. Patients are seen regularly~     (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of~     patients additionally receives a subcutaneous implantation of a loop recorder for continuous~     rhythm monitoring, while the control group remains on standard follow-up. Observation period~     is one year (optional extension for 3 years). The time to first diagnosis of AF is compared~     between groups, blood samples are analyzed for potential biomarkers of AF.~   "
121813|NCT01461421|"~     The proposed project is testing two behavioral interventions designed to improve long-term~     weight loss among participants who struggle with eating in response to stress or emotional~     experiences. Group treatment lasts for 1 year, with assessments lasting 2 years.~     Participants must live in the greater Providence, Rhode Island area in order to be eligible.~   "
121814|NCT01461408|"~     The investigators propose a non-randomized pilot study to assess the feasibility and~     effectiveness of using urban beauty salons as settings for culturally-competent health~     education about HPV vaccination. The educational messages will engage individual women,~     their peer group, their family members and community influencers in a way that is authentic~     and share-able. Involving women in give-and-take discussions with people they trust and~     respect—their hairdressers—will be essential to increasing the number of them who consider~     the HPV vaccine for themselves and for those they care about. The investigators believe that~     it is only after women who are opinion leaders among their peers begin positively supporting~     HPV prevention that it will gain wider acceptance.~      The investigators plan to recruit eight (8) predominantly African American beauty salons in~     Philadelphia and train multiple stylists in each salon to act as in-salon educators and~     facilitators for client recruitment to sexual health education sessions. These education~     sessions will be run by trained health educators (also African American females) and take~     place during down times in each of the salons, on a rotating basis.~        -  The investigators hypothesize the ability to successfully recruit eight (8) beauty~          salons for participation~        -  The investigators hypothesize the ability to successfully train multiple stylists per~          site to talk to their clients about HPV and its impact on women of color~        -  The investigators hypothesize that knowledge and awareness of HPV, as well as~          intentions to vaccinate will significantly improve among women who attend a salon-based~          health education session~   "
121815|NCT01461395|"~     The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic~     acid, which is the genetic material inside your cells) alterations in the sperm's head, in~     the near future leading us to choose the good sperm in a simplified manner. This could~     then increase chances of a successful in-vitro fertilization (IVF) treatment when there are~     sperm abnormalities.~   "
121816|NCT01461382|"~     Is a one-year intervention with Treadmill Desks associated with increased employee daily~     physical activity and decreased sedentariness.~      36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for~     one year. Daily Physical Activity, work performance, body composition, and blood variables~     were measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.~   "
121817|NCT01461369|"~     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and~     effective for the treatment of osteoarthritis pain of the hip or knee.~   "
121818|NCT01461356|"~     The hypothesis of the proposed study is that performing total knee arthroplasty through a~     mini subvastus approach results in statistically significant differences in one or more of~     the above functional outcome measures, when compared in a blinded, prospective, controlled,~     randomized manner to mini-medial arthrotomy approach.~        1. Analyses of lower extremity functional activities (gait and stairs)~        2. Strength of thigh musculature~        3. Self-assessment of the functional outcomes~        4. Return to the activities of daily living and sports activities~   "
121819|NCT01461343|"~     The purpose of the study is to find out how the blood flow changes in the lungs of people~     with pulmonary hypertension compared to healthy individuals without pulmonary hypertension.~     We would like to find out if there are differences in how blood flows when subjects are~     given a drug to dilate (widen) the arteries in their lungs and when they breathe extra~     oxygen. We will compare the results to when subjects don't receive any drug or extra oxygen.~     We hope that knowing about these differences will help us to better understand pulmonary~     hypertension and how to diagnose it earlier.~   "
121820|NCT01461330|"~     Data obtained in hypertensive patients without diabetes suggest that increased association~     of non-pharmacological treatment in patients with diabetes and hypertension may be~     associated with an improvement in blood pressure control. Despite the beneficial results~     found, is not yet known the magnitude of the effect of a DASH diet associated with the~     stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects~     on blood pressure of an additional non-pharmacological intervention to drug therapy may have~     an even greater impact in patients with treatment-resistant hypertension The aim of this~     study is to evaluate the effect of changes in lifestyle on blood pressure in patients with~     type 2 diabetes and hypertension resistant to treatment.~   "
121821|NCT01461317|"~     This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of~     etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were~     enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for~     entry in the OLE study.~   "
121822|NCT01461304|"~     This is a compassionate use study to allow patients already taking triheptanoin (C7) through~     previous studies to continue to receive the supplement. It will also allow triheptanoin~     supplementation in patients with qualifying disorders if they are failing conventional~     therapy.~   "
121823|NCT01461291|"~     Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400~     using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery~     only, in subjects with mild to moderate primary open-angle glaucoma.~   "
121824|NCT01461278|"~     Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in~     conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild~     to moderate primary open-angle glaucoma.~   "
121825|NCT01461265|"~     This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain~     associated with metastatic bone tumors.~   "
121826|NCT01461252|"~     This study will evaluate the safety and efficacy of cryoablation therapy combined with~     radiation therapy for the relief of pain associated with metastatic bone tumors.~   "
121827|NCT01461239|"~     There are few randomized controlled trials comparing intraradicular posts used to restore~     endodontically treated teeth, especially considering cast posts and glass fiber posts. The~     investigators study will evaluate the clinical success rates of endodontically treated teeth~     restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included~     in this study should present any tooth with endodontic treatment and need of intraradicular~     retention (post) on maxilla or mandible according to inclusion and exclusion criteria.~     Individuals will be randomly allocated into two groups: (1) endodontically treated teeth~     restored with fiber post and composite resin core and metal ceramic crown or (2)~     endodontically treated teeth restored with cast post and core and metal ceramic crown. A~     sample size calculation will be performed to establish the number of posts needed for~     comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals~     will be examined by calibrated examiners, in years 1 to 3. The reason of failure will be~     categorized as root fracture, fracture of the post, post debonding, clinical and/or~     radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth~     extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.~   "
121828|NCT01461226|"~     The purpose of this study is to objectify the effect of diet and exercise on early markers~     of atherosclerosis in obese children.~   "
121829|NCT01461213|"~     - Primary objective: To assess the safety and tolerability of the AAV.REP1 vector,~     administered at two different doses to the retina in 12 patients with a diagnosis of~     choroideremia.~      - Secondary Objective: To identify any therapeutic benefit as evidenced by a slowing down of~     the retinal degeneration assessed by functional and anatomical methods in the treated eye~     compared to the control eye 24 months after gene delivery.~   "
121860|NCT01460784|"~     The investigators propose to conduct a cross-sectional study of 60 participants who are~     18-30 years of age to undergo research PET/CT. The purpose of this study is to investigate~     the relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio,~     and components of the metabolic syndrome in young adults.~   "
121861|NCT01460771|"~     The investigators hypothesize that transcranial direct current stimulation over the motor~     cortex will reduce muscle overflow and improve hand function in children with primary or~     secondary dystonia.~   "
121830|NCT01461200|"~     The purpose of this study is to find out if the bacteria present in the nose or sinuses of~     people with seasonal allergies changes during their allergy season. Another purpose of this~     study is to see if the bacteria present in the nose and sinuses of non-allergic people are~     the same as allergic people before the allergy season and if it changes during the season.~     Many bacteria are difficult to grow in the laboratory so the investigators are using~     analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to~     find them. The investigators will be testing DNA of the bacteria only and not of the human~     subjects taking part in this study. This research is being done to help us understand how~     allergy affects bacteria in the nose and sinuses.~   "
121831|NCT01461187|"~     Abstract:~      Objectives:[The goal is] to confirm if physical activity of medium intensity performed~     during gestation can influence the way of delivery, and observe the adherence to exercise~     among pregnant women with different education levels. Methods: Held at the Center for~     Breastfeeding Incentive in the city of São Sebastião, State of São Paulo (Brazil), between~     April 7, 2008 and April 14, 2009, the prospective study involved 66 primigravid women, who~     were divided into two groups: the exercise group (GE) that exercised regularly during~     pregnancy, and the other control group (GC) that did not exercise regularly during same~     period. The significance level adopted in this study was five per cent (p = 0.05).~   "
121832|NCT01461174|"~     The aim of this study is to assess the utility of sleep deprivation as a potential model for~     prediction of clinical efficacy using a combination of cognitive physiological endpoints.~   "
121833|NCT01461161|"~     This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl~     administered to normal healthy adult subjects.~   "
121834|NCT01461148|"~     Patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated~     with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined~     with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs~     that are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to~     show that vaccination against MSI-induced FSPs is safe and can induce or enhance immune~     responses against MSI-H colorectal cancer-associated antigens.~   "
121835|NCT01461109|"~     The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to~     evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and~     Alzheimer Disease (AD) research participants.~   "
121836|NCT01461096|"~     Men who have sex with men (MSM) have an increased risk of developing anal human~     papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected~     women are also at risk of anal cancer. This study will evaluate the effectiveness of the~     Food and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at~     preventing anal HPV infection in HIV-infected MSM and HIV-infected women.~   "
121837|NCT01461083|"~     The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate~     the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research~     participants.~   "
121838|NCT01461070|"~     Background:~      - Some bacteria found in the large and small intestines help keep people healthy and aid~     digestion. They may also affect a person s risk of developing cancer. Researchers want to~     study the relationship between intestinal bacteria and breast cancer risk factors. They can~     do this by looking at stool and urine samples from postmenopausal women.~      Objectives:~      - To study intestinal bacteria and its relationship to urine-based markers of breast cancer~     risk in women.~      Eligibility:~      - Women between 55 and 69 years of age with a recent mammogram that showed no signs of~     cancer.~      Design:~        -  Participants will be screened with a medical history and basic health questionnaire.~        -  At home, participants will complete questionnaires about cancer risk factors and food~          consumption.~        -  Participants will also collect urine and stool samples. They will send the samples to~          the designated labs for study.~        -  No treatment will be provided as part of this protocol.~   "
121839|NCT01461057|"~     This randomized, multicenter, open-label study will evaluate two different doses of~     pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line~     treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or~     gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment~     arms. Participants in Arm A will receive a pertuzumab loading dose of 840 mg for Cycle 1 and~     a dose of 420 mg for Cycles 2-6, and participants in Arm B will receive pertuzumab 840 mg~     for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin,~     and capecitabine.~   "
121840|NCT01461044|"~     This observational study will evaluate the safety and efficacy of triple negative or HR+~     patients with HER2-metastatic or locally advanced breast cancer treated with Avastin~     (bevacizumab) as first line therapy for at least 12 months and without disease progression~     for at least 12 months. Data will be collected retrospectively (from the diagnosis to the~     inclusion in the study) and for 18 months from study start.~   "
121841|NCT01461031|"~     The aim of this study is to determine the analgesic effect of perioperative nefopam on acute~     pain in patient undergoing orthognathic surgery.~   "
121842|NCT01461018|"~     The purpose of this study is to assess the long-term efficacy, tolerability, and safety of~     IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding~     follow-up study ZLB07_001CR (NCT01458171).~   "
121843|NCT01461005|"~     The purpose of the Post-Market Surveillance study is to evaluate safety.~   "
121844|NCT01460992|"~     This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS~     pacemaker system when used under specific MRI conditions.~   "
121845|NCT01460979|"~     The purpose of this study is to determine the activity, tolerability and safety of~     Temsirolimus in women with ovarian cancer who progressed during the previous platinum~     chemotherapy alternatively within 6 months from completion of therapy or advanced~     endometrial carcinoma.~   "
121846|NCT01460966|"~     Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for~     distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the~     effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™)~     in the aforementioned subgroup of patients at high risk for distal embolism.~   "
121847|NCT01460953|"~     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the~          effectiveness of an educational training video on the topic of health literacy for~          medical students.~        2. Briefly summarize how participants are recruited: OHSU medical students attending~          mandatory trainings on the topic of health literacy during the 1st and 2nd years of~          medical school will be invited to participate in the study.~        3. Briefly describe the procedures subjects will undergo: Completion of a short~          self-administered anonymous survey before and after viewing a 23-minute video about~          health literacy.~        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test~          questionnaire and 13-item post-test questionnaire designed to assess individuals'~          knowledge about health literacy, and intended clinical practices with respect to health~          literacy.~        5. If this is a clinical trial using an experimental drug and/or device, or an approved~          drug and/or device used for an unapproved purpose, briefly describe the drug and/or~          device: n/a~        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:~          Demographics and responses to individual items will be reported as frequencies and~          percentages within the sample. The investigators will use a chi-square analysis to~          stratify responses by demographic groups and t-tests to measure possible changes over~          time.~   "
121848|NCT01460940|"~     This phase II trial studies how well giving panobinostat together with lenalidomide works in~     treating patients with relapsed or refractory Hodgkin lymphoma. Panobinostat may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological~     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop~     cancer cells from growing. Giving panobinostat together with lenalidomide may be an~     effective treatment for Hodgkin lymphoma~   "
121849|NCT01460927|"~     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,~     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple~     treatments. The primary endpoint is observation of changes to the surface by visual and~     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort~     of the treatment and the measurement of adverse events.~   "
121850|NCT01460914|"~     Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which~     the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV~     light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also~     effective for graft-versus-host disease (GVHD). The investigators would like to study the~     outcomes (response rates) of patients receiving ECP treatment and other factors relating to~     their disease and treatment, as well as procedural events, such as complications.~   "
121851|NCT01460901|"~     This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic~     transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory~     neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated.~     The study will focus on the safety and efficacy of allogeneic, donor derived viral specific~     cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor~     specific for disialoganglioside, GD2, expressed on neuroblastoma.~   "
121852|NCT01460888|"~     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of olaparib in~     combination with radical radiotherapy in patients with oesophageal cancer who are unsuitable~     for platinum containing chemotherapy.~   "
121853|NCT01460875|"~     This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with~     melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and~     slow the growth of melanoma~   "
121854|NCT01460862|"~     A retrospective database analysis to evaluate the impact of omalizumab on the use of~     corticosteroid, emergency-department visits and hospitalizations among patients with~     uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating~     omalizumab.~   "
121855|NCT01460849|"~     Using CFF registry data, this analysis will: describe patterns of time to TIS initiation~     from first year of TIS eligibility, estimate the increased risk of death attributable to~     each year of delayed TIS initiation, and investigate TIS effects across study centers.~   "
121856|NCT01460836|"~     Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine~     (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data~     from published literature.~   "
121857|NCT01460823|"~     The investigators are studying a new way of doing cochlear implant surgery called~     Percutaneous Cochlear Implantation. In this surgery, instead of doing a mastoidectomy~     where about 30ml of bone is removed, the investigators use image-guided technology (similar~     to GPS systems used to guide automobile travel) to drill directly from the surface of the~     skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers~     (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head~     (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is~     planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill~     will be attached to the guide and used to drill a path from the surface of the skull to the~     inner ear (cochlea). The implant electrode will be threaded through this path. All of these~     procedures take place under general anesthesia.~   "
121858|NCT01460810|"~     A prospective, experimental, case series of 20 patients, with choroidal melanoma, in which~     pars plana vitrectomy and Silicone oil as vitreous substitute will be used as intraocular~     shielding for attenuating the deleterious effects of radiation dose delivered to healthy~     ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment~     can reduce the incidence and severity of radiation-induced adverse effects like radiation~     retinopathy and permanent loss of vision.~   "
121859|NCT01460797|"~     The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research~     on Glycemic Index (GI) diets has been largely developed, however the combination with~     metformin in humans was not investigated yet. We hypothesized that the low-GI diet in~     combination with metformin would elicit greater improvements on glucose metabolism, lipid~     profile and body composition on overweight or obese type 1 subjects. This study aims to~     evaluate the metabolic effects of the adoption of dietary advice to follow caloric~     restriction high/low GI diets, and low-GI diet associated with metformin on glucose~     metabolism, lipid profile and body composition on overweight or obese type 1 subjects.~   "
121862|NCT01460758|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal~     excitability in patients with depression. In the present study the investigators will~     examine whether medial frontal rTMS using a double-cone-coil proves to be superior to~     conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a~     butterfly-coil.~   "
121863|NCT01460745|"~     This study is a multi-centre retrospective observational research study which will be~     conducted in UK centres with specialised liver surgical services.~      The study will involve retrospective review of medical records of patients with metastatic~     colorectal cancer (mCRC) with metastases confined to the liver, defined locally as~     unresectable without downsizing therapy at first review by a Hepatobiliary Multi~     Disciplinary Team (HPB MDT). Erbitux is available for use in combination with chemotherapy~     as a downsizing treatment for patients with previously unresectable metastases.~      The study aims to examine liver resection rates achieved in normal clinical practice in~     order to inform National Health Service (NHS) clinical and policy decision making and to~     further understanding of how cetuximab is used in a standard clinical setting. This study~     intends to estimate the proportion of patients with unresectable liver metastases who~     undergo liver resection following downsizing treatment with chemotherapy plus cetuximab.~   "
121864|NCT01460732|"~     This is a cross-sectional study, including adults, either untreated for hypertension, or~     under stable treatment for more than four weeks. Assessment will include:~      Clinic blood pressure measurements with an automated oscillometric device, 24-hour~     ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening~     and nocturnal measurements with the same device.~   "
121865|NCT01460719|"~     An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated~     Varicella-Zoster Virus (V212) vaccine in participants with hematologic malignancies (HM) who~     are currently receiving anti-CD20 monoclonal antibodies.~   "
121866|NCT01460706|"~     The purpose of this study is to characterize tumour uptake of somatostatin analog~     68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The~     investigators hypothesis is that some primary and recurrent malignant gliomas overexpress~     SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also~     hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically~     determined SST2 receptor status of the tumor specimen.~   "
121867|NCT01460693|"~     Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed~     Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way~     indicates an 89% probability of progression-free survival. Imatinib is not tolerated or~     effective in some patients however, and a proportion of patients become resistant to the~     drug. SPIRIT 2 study aims to establish whether a new drug, dasatinib, is superior to~     imatinib in terms of event free survival and therefore will be an effective first-line~     therapy for newly-diagnosed CML patients. This study will also provide crucial long-term~     survival, quality of life and health economic data to assist health care providers and~     managers to determine the most cost-effective drug therapy for CML.~   "
121868|NCT01460680|"~     Polyunsaturated omega-3 fatty acids (ω3 PUFAs) are essential nutrients. Studies indicate~     that the incidence of Major Depression (MD) is inversely related to the consumption of fish~     (which are rich in ω3-PUFAs) and to the concentration of ω3 PUFAs in the plasma or Red Blood~     Cell (RBC) membranes. In several studies, the ω6 to ω3 ratio was elevated (ω6 PUFAs are~     pro-inflammatory, compared to ω3). ω3 PUFAs are also inversely associated with anxiety and~     neuroticism but apparently not with somatization.~      Supplementation of fish oil alleviates joint pain in patients with auto-immune disease.~     Inhibition of pro-inflammatory cytokines (which induce both pain and depression-like~     symptoms) by ω3 PUFAs may underlie the benefit conferred by fish oil consumption . RBC ω3~     PUFA content is lower in patients with Systemic Lupus Erythematosus and chronic fatigue~     syndrome, compared to healthy controls. The ω3 PUFA status of fibromyalgia patients has not~     been assessed.~      Magnesium is an essential nutrient and plays a regulatory role in neural transmission. It is~     not known whether magnesium concentration is associated with pain in humans.~      The objectives of the current study are to 1) compare the mean RBC omega-3 content in female~     fibromyalgia patients compared to that of healthy controls and female SLE patients, and to~     2) assess the correlation between RBC omega-3 content and between the severity of physical~     (e.g. pain) and mental (e.g. depression) in fibromyalgia and Systemic Lupus Erythematosus~     (SLE).~   "
121869|NCT01460667|"~     Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length~     of stay and morbidity is intimately associated with post-operative nausea and vomiting~     (PONV) and recovery of bowel function. Medications most commonly used to control for~     post-operative pain are opioid medications, whose well known adverse effects include PONV.~     Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief~     without the aforementioned risks.~      The primary goal for this study is to evaluate the the administration of pre- and~     post-operative IV acetaminophen to determine if there is in an overall decrease in the use~     of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in~     subjective PONV leading to sooner return of bowel function, enabling progression to oral~     intake and decrease in post-operative length of stay.~   "
121870|NCT01460654|"~     This study will investigate the hypothesis that the combination of testosterone replacement~     and alendronate will improve bone density and parameters of bone quality more than either~     medication alone in older men with low testosterone levels and low bone density.~   "
121871|NCT01460641|"~     A research study of rectal cancer perfusion (how blood flows to the rectum over time). We~     hope to learn whether perfusion characteristics of rectal masses may be predictive of~     response to treatment and whether rectal perfusion characteristics can be used to follow~     response to treatment.~   "
121872|NCT01460628|"~     The purpose of this study is to determine if armodafinil improves quality of life and is an~     effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.~   "
121873|NCT01460615|"~     The purpose of this randomized, placebo-controlled trial is to investigate whether~     postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy~     (Whipple) operation may be reduced with cortisone treatment. Treatment is administered to~     high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).~   "
121874|NCT01460602|"~     This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan~     (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell~     Lymphoma.~   "
121875|NCT01460589|"~     This study sets up the final study end point and three detailed goals as the following.~      The main objective of study: This trial is done to assess the safety and benefit of early~     adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional~     commencement after 2weeks for treatment of patients with colon cancer.~      Detailed goal of study:~      The primary endpoint: This study is designed to assess whether early commencement of~     adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and~     recurrence rate.~      The secondary endpoint: This study aims to compare short-term cumulative complications~     between early and conventional commencement of adjuvant chemotherapy after laparoscopic~     resection of colon cancer. This study will also assess the quality of life and side effects~     of chemotherapy.~   "
121876|NCT01460576|"~     The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and~     long-term breathing problems in preterm infants by investigating two interrelated~     biochemical pathways: the urea cycle-nitric oxide pathway and the glutathione pathway. The~     investigators hypothesize that prematurity-related limitations in the function of these~     important biochemical pathways contribute to respiratory disease risk over the first year of~     life.~   "
121877|NCT01460563|"~     The investigators hypothesized that valproic acid will increase rocuronium requirement and~     MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded~     with sodium valproate.~   "
121878|NCT01460550|"~     The purpose of this study is to evaluate the incidence of delayed gastric emptying in~     patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal~     reconstruction.~   "
121879|NCT01460537|"~     This open label Phase I study involves treating subjects with advanced cancer with~     Copanlisib in combination with either gemcitabine or cisplatin plus gemcitabine. It will~     determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib~     in combination with gemcitabine and Copanlisib in combination with cisplatin and~     gemcitabine. The trial will involve multiple participating sites from the US. Up to a~     maximum of 70 subjects will be enrolled in the study.~   "
121880|NCT01460524|"~     In randomized controlled trials, the use of nebulized hypertonic saline in acute~     bronchiolitis has been reported to improve respiratory distress scores, to reduce length of~     hospital stay and to show a trend towards lower hospitalization rates.~      The investigators aim to verify by an observational study if the rate of hospital admission~     and the length of hospital stay of infants presenting to the emergency department (ED) with~     bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the~     treatment strategy of the ED and hospitalization wards.~      The investigators will assess the evolution of hospital admission rates and the length of~     hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment~     of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized~     hypertonic saline is effective in this setting, then the hospitalization rates and length of~     stay should be lower during the year of hypertonic saline use compared to two previous years~     when this therapy was not used. These parameters would not be modified in centers that do~     not use hypertonic saline.~   "
121881|NCT01460511|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week~     study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo~     HFA-MDI in pediatric patients who are 4-11 years of age with asthma.~   "
121882|NCT01460498|"~     This is a 2 part study. The goal of the first part of this clinical research study is to~     find the highest tolerable dose of azacitidine that can be given with a TKI that you are~     already taking (such as Gleevec, Sprycel, or Tasigna). The safety of this drug will also be~     studied. The goal of the second part is to see if this combination may improve your response~     to the TKI you are already taking.~      Azacitidine is designed to change genes that are thought to cause leukemia. By changing~     these genes, the drug may help to stop them from causing the disease to grow.~   "
121883|NCT01460472|"~     This is a prospective, randomized, open label, parallel-group, multicenter phase III study~     to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus~     best supportive care versus best supportive care in patients with advanced NSCLC who have~     achieved an Objective Response (Partial or Complete Response) or Stable Disease with~     standard first-line treatment. Also immunological parameters will be evaluated. Best~     supportive therapy will be administered to all patients in the study according to~     institutional standards and includes any subsequent onco-specific therapies. 1082 patients~     will be included in the study, with non-small cell lung cancer in stages IIIA~     (non-resectable), IIIB or IV.~   "
121884|NCT01460459|"~     Primary Objective:~      The objective of the study is to investigate the effect of a specific frequency of~     Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients~     with type 2 diabetes and who are in stable good glycemic control and using 1 insulin~     injection daily.~      The research question is:~      Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes,~     who are in stable good glycemic control, using 1 insulin injection daily, lead to a~     clinically relevant increase of HbA1c (an increase of 0.5%) and what is the effect on~     quality of life?~      Secondary objectives:~      The secondary objectives is to investigate the effect of a specific frequency of SMBG on the~     number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the~     health care provider, and the diabetes medication.~   "
121885|NCT01460446|"~     This clinical, prospective, randomized, multi-center study determined if the use of an~     insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients~     failing multiple daily injection/intensified conventional therapy (MDI/ICT).~   "
121886|NCT01460433|"~     The aim of this study is to find out if the process of HIV replication in the lymph tissue~     and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut~     to protect you from other infections and health problems.~   "
121900|NCT01460251|"~     The study is an open-label extension study, offering patients who participated and completed~     previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and~     clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety~     and efficacy data of long term treatment effect of Diapep277.Only patients who completed~     studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L~     will be eligible for this extension study~   "
121887|NCT01460420|"~     The aim of the current study is to improve the outcome of patients with hematologic~     malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II~     trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve~     the efficacy of the procedure decreasing the risk of relapses after transplant.~      Currently, the standard approach used in most centers to prevent graft-versus-host disease~     after allogeneic transplantation is based on the combination of a calcineurin inhibitor~     (cyclosporine or tacrolimus) plus a short course of methotrexate. Unfortunately, this~     strategy is far from ideal, since the risk of acute GVHD is in the range of 30-40% among~     patients receiving a matched related donor transplantation and even higher among patients~     receiving transplantation from an unrelated donor while the incidence of chronic GVHD is~     60-70% among patients receiving peripheral blood progenitor cells from either a related or~     unrelated donor.~      As far as the patients with multiple myeloma (MM) is concerned, although the development of~     new drugs has markedly changed the outcome and management of these patients, allogeneic~     transplantation so far appears to be the only curative option, especially among those~     patients relapsing after first line treatment. Nevertheless, still new strategies within the~     allogeneic transplant setting are needed to improve its results.~      Relapses may occur either extramedullary (very common in this setting) or systemic. In order~     to reduce the risk of systemic relapses the investigators will use maintenance therapy with~     Lenalidomide (Len) which, together with bortezomib (Bz) should contribute to eradicate~     minimal residual disease (MRD). In case the patient do not obtain complete remission or near~     complete remission after transplant, in addition to the maintenance therapy, the~     investigators will use four intensification cycles with VRD (Bz-Len-Dexamethasone).~      In summary, the goal is to optimize the efficacy of allogeneic transplantation by two~     interventions: one focused on reducing the risk of relapse and the other on reducing the~     incidence of GVHD.~   "
121888|NCT01460407|"~     The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of~     LY2216684 in healthy participants. Side effects will be documented. There will be 2 study~     periods (5 and 9 days) and follow up will occur at least 7 days after the last dose.~     Screening is required within 45 days prior to the start of the study.~   "
121889|NCT01460394|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response~     in two age groups: adolescents and young adults.~   "
121890|NCT01460381|"~     The study will evaluate how genetic profiles respond to LY2216684 and the effect of~     Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side~     effects will be documented.~   "
121891|NCT01460368|"~     Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects~     due to blood sugar changes after a meal compared to when LY2409021 is also given with a~     meal.~      Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose~     level much higher than what would normally be given, on the electrical activity of the heart~     as measured by ECG in relation to placebo and moxifloxacin.~   "
121892|NCT01460355|"~     Two different treatments were given to large angle horizontal strabismus (eso and exotropia)~     adult patients who agree to participate of the study. Inform consents were required for~     participants. Group 1 (12 patients) received conventional recess-resect surgery plus~     intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only~     conventional recess-resect surgery. The patients were randomly located in one of the groups.~     The angles of horizontal deviation were compared between the groups before and six months~     after treatment.~   "
121893|NCT01460342|"~     This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design,~     multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for~     12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.~   "
121894|NCT01460329|"~     The purpose of this study is to compare the accuracy and precision of two non-invasive~     methods of measuring cardiac output in critically ill children (<18 yrs). The participants~     will include any patient admitted to Pediatric intensive care unit (PICU) requiring a~     trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent~     cardiac output will be obtained and compared on participants using standard 2-D TTE and~     Ultrasound Cardiac Output Monitor (USCOM).~   "
121895|NCT01460316|"~     The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects~     regarding the relations between the metabolic, the genetic and the environmental factors~     which lead to these cardiopathy.~   "
121896|NCT01460303|"~     Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are~     sometimes temporarily unable to empty their bladders and are sent home with a transurethral~     indwelling catheter attached to a bag which holds urine. The goal of this study is to~     compare a new type of patient-operated catheter without a bag to the catheter with a bag for~     ease of use, comfort and quality of life for patients during the postoperative recovery~     period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the~     market.~   "
121897|NCT01460290|"~     Objectives: The investigators propose a first-ever, prospective trial of asenapine in older~     adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and~     functional/general health status. Given the dearth of treatment data on older adults with~     BD, findings are likely to be of substantial clinical interest, may inform larger future~     studies and will assist in refining bipolar treatment recommendations.~      Hypotheses:~      Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive~     symptoms in older adults with BD.~      Secondary: Asenapine therapy will be associated with improved functional and general health~     status, improved global psychopathology, and good tolerability in older adults with BD.~   "
121898|NCT01460277|"~     The purpose of this current prospective study is to assess and compare the effects of a~     hydrotherapy exercise programme against a conventional land-based exercise programme in~     individuals with hemiplegia. Both exercise interventions aim at improving posture, balance~     and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional~     therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and~     >60 years). The physical examination consisted of (1) a lower-limb motor function recovery~     of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb~     strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and~     plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified~     Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural~     control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional~     status measured with the Functional Independence Measure. Postural sway was evaluated with a~     pressure platform by using the variables of center of pressure (COP) displacements in the~     mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and~     evaluated using statistical programme SPSS.~   "
121899|NCT01460264|"~     This is an observational study aiming to identify and validate biomarkers (including imaging~     and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular~     disease (CVD) and lung cancer.~   "
121901|NCT01460238|"~     The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic~     Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results~     from this proposal will validate the use of a novel antibody developed at~     Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of~     the disease. The investigators work will also provide direct evidence that LPL is expressed~     on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow~     and survive. Fatty acid metabolism may become a therapeutic target in CLL in the future.~   "
121902|NCT01460225|"~     This prospective study is designed to evaluate how lubiprostone may affect gastric motor and~     sensory function.~   "
121903|NCT01460212|"~     Study hypothesis: psychotherapy and SSRI treatment effect in different brain way:~     psychotherapy in up to down way and SSRI in down to up way. The investigators will~     explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance~     Imaging analysis in this study. Patients in different groups will be treated by~     psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging~     pro and after 12 weeks of treatment.~   "
121904|NCT01460199|"~     This study is being conducted to evaluate the safety and tolerability of treatment with~     CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.~   "
121905|NCT01460186|"~     This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is~     to identify germ line genetic factors that influence the risk of metastatic breast cancer.~      1500 patients will be enrolled in this study. Blood samples will be collected after informed~     consent and inclusion in the study.~      Patients will be treated and followed according to the standards of their treating center.~      They will be followed during at least 5 years every 6 months for 3 years then every year.~   "
121906|NCT01460173|"~     Driving simulator programmes are used under a wide range of conditions, and a correlation of~     driving performance and real accident risks in patients with obstructive sleep apnoea~     syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided~     Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until~     today there are no reference levels with regards to sex and age in existence. To define the~     boundaries of normality age and sex reference values are to be generated and compared to~     values of patients with OSAS.~      50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will~     perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as~     well. A better differentiation of pathologic driving performance and response times of OSAS~     patients should be possible with new reference levels.~   "
121907|NCT01460160|"~     The purpose of this study is to determine whether Dasatinib when added to standard~     chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome~     positive acute lymphoblastic leukemia~   "
121908|NCT01460147|"~     The purpose of this study is to evaluate bone mineral density in adult subjects with~     hemophilia versus a comparator population without hemophilia (non-hemophilia age- and~     gender-matched database) by using the following diagnostic means: dual-energy X-ray~     absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers.~     In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to~     loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI~     substudy). No investigational product will be dispensed.~   "
121909|NCT01460134|"~     This is a study of CDX-1127, a therapy that targets the immune system and may act to promote~     anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias~     and lymphomas), as well as patients with select types of solid tumors.~   "
121910|NCT01460121|"~     The diagnosis and management of acute vertigo and dizziness is most of the time an easy task~     for the general practitioner. However, following an acute vestibular disorder and very often~     with no any overt cause, a considerable number of patients complain on chronic dizziness and~     subjective disturbance of balance despite normal clinical and laboratory tests. Patients~     describe that perceptual visual stimulus provoke or aggravate their symptoms that are~     frequently accompanied by anxiety. These cases have been described in the medical literature~     as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and~     Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar~     to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as~     benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.~      Because visual stimuli play a crucial role in space orientation and motion perception, it is~     reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral~     visual field (that is involved mainly in the perception of motion) could be of help in~     patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso~     Mental Balance Technology) developed to alleviate the feelings of dizziness.~      Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!~   "
121911|NCT01460108|"~     The purpose of this study is to characterize the safety and efficacy of the AeriSeal System~     in patients with advanced upper lobe predominant emphysema and significant collateral~     ventilation as determined by the Chartis System.~   "
121912|NCT01460095|"~     Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in~     diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering~     HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c~     measurement to patients improves control. However, HbA1c is unavailable in most parts of~     Africa, a continent with one of the highest burden of diabetes. To translate these~     evidences, the investigators will provide affordable access to HbA1c measurement and~     relevant education in 2 African countries aiming significant improvement of diabetes~     control. The investigators will develop with local health authorities, training and~     cost-recovery scheme for long-term sustainability.~   "
121913|NCT01460082|"~     The purpose of the study is to determine a possible association between the clinical entity~     of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients~     with COPD.~   "
121914|NCT01460069|"~     The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on~     psoriasis in a double-blinded, randomized placebo-controlled clinical trial.~   "
122236|NCT01455844|"~     The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for~     12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high~     hypertriglyceridemia as compared to a placebo.~   "
121915|NCT01460056|"~     This observational retrospective healthcare medical record review study is to evaluate and~     differentiate the clinical characteristics and outcomes in peritoneal dialysis (PD) patients~     with either endotoxin-associated sterile peritonitis (e-SP), bacterial peritonitis (BP) or~     no peritonitis (NoP) over a 12-15 month period from dialysis clinics in The Netherlands,~     Germany, Hungary, Portugal, and the United Kingdom (UK).~      The primary study objectives are to:~        -  Describe changes in the peritoneal membrane function and clinical outcomes over time~          between e-SP, BP and NoP PD patients.~        -  Describe and differentiate clinical characteristics during the acute clinical~          presentation of e-SP and BP.~      The secondary study objective is to:~      - Generate a dataset that will facilitate post hoc exploratory hypothesis-generation related~     to clinical and resource utilisation (RU) outcomes in association with e-SP.~   "
121916|NCT01460043|"~     The purpose of this study is to compare outcomes and quality-of-life issues in the treatment~     of menorrhagia, this randomized double blind controlled trial compared homeopathy and~     placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the~     condition was performed during one pre-treatment and three treatment cycles. outcome~     measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal~     & back pain, General health and overall satisfaction.~   "
121917|NCT01460030|"~     This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy~     of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or~     intractable primary hyperparathyroidism (PHPT).~   "
121918|NCT01460017|"~     The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer~     procedure and may yield better results than trabeculotomy trabeculectomy approach.~   "
121919|NCT01460004|"~     The purpose of this study is:~        -  To examine the effect of infra patellar strap treatment on the extent of pain and~          jumping performance tasks in young male athletes diagnosed with patellar tendinopathy.~        -  40 elite male athletes, basketball and volleyball players, ages 14-18, students of the~          academy for sports Excellency will take part in this study~        -  Hypothesis 1: The treatment of infra patellar strap will reduce the level of pain~          during jumping performance tasks.~        -  Hypothesis 2: The treatment of infra patellar strap will improve the squat jump height~          in athletes with patellar tendinopathy during squat jump task.~        -  Hypothesis 3: The treatment of infra patellar strap will improve the drop jump height~          in athletes with patellar tendinopathy during drop jump task.~        -  Hypothesis 4: The treatment of infra patellar strap will improve the one leg jump~          height in athletes with patellar tendinopathy during one leg jump task.~        -  Hypothesis 5: The treatment of infra patellar strap will improve the 30 seconds~          repetitive jumps mean height in athletes with patellar tendinopathy during 30 seconds~          repetitive jumps task.~   "
121920|NCT01459991|"~     Purpose: During lactation, several physiological modifications occur including cellular~     differentiation and proliferation, as well as elevation in inflammation. The role of the~     Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid~     profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory~     effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory~     response.~      Procedures: A randomized, controlled dietary intervention trial among lactating women~     comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid~     Diet for Moms was commenced to determine the effects of the diet on fatty acid profiles and~     biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of~     interest include effects of maternal diet assignment on maternal body weight and body~     composition as well as infants' growth and health during the study trial period.~      Population: The study population includes healthy women between the ages of 18-40 years who~     are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6~     months following study entry. There have been a total of 138 participants enrolled in the~     study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said~     they were not Hispanic.~   "
121921|NCT01459978|"~     Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM:~     Cumulative Sum) will increase the awareness of health care staff in maternity and permit~     rapid detection of a small dip in performance in order to enable prompt investigations and~     corrective measures when necessary , which decrease maternal and neonatal mortality and~     morbidity.~      Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity~     dashboard to decreases maternal and neonatal mortality and morbidity.~      Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.~      Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants~     could be collected over 2 year's period.~      Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators~     previously selected by Delphi method.~      Main Outcome Measures: Composite outcome that considers multiple clinical events :~     mortality, adverse outcomes for women and newborn.~   "
121922|NCT01459965|"~     Endoscopic stent insertion is considered the method of choice for palliation of malignant~     bile duct obstruction (MBDO). However, it can cause complications and requires periodic~     stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or~     refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic~     stenting for this relative indication might be justified, if there is a significant~     improvement in quality of life (QOL) of such patients. The aim of the investigators study~     was to determine whether endoscopic stenting for MBDO results in improved QOL.~   "
121936|NCT01459783|"~     Dementia is a condition that is growing in prevalence and which harms not only the afflicted~     individual but also adversely affects the health of their family and other informal~     caregivers. New methods for delivering comprehensive assistance to persons with dementia and~     their caregivers are known to be effective and can delay nursing home placement, but this~     study will discover 1) whether more face-to-face involvement rather than telephone delivery~     of this assistance will work better among poor patients in Los Angeles, and 2) if one method~     is better than the other, what are the differences in costs between them. These data will~     enable administrators in public health care settings around the US and non-profit~     foundations addressing dementia patient and caregiver needs to decide what method provides~     the best value and the best outcome relative to its cost.~   "
121923|NCT01459952|"~     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase~     III study.~      After the patient has receiving information about the study and after given written informed~     consent, the patient will be screened.~      The patient's medical history and demographic information will be recorded. The patient will~     then be asked questions in accordance to the study questionnaires, and they will also be~     asked to complete questionnaires regarding quality of life - and finally they be instructed~     on how to complete the diary.~      All patients are randomized to receive standardized rose hip liquid or matching placebo. The~     subject is instructed to take the liquid form of rose hips in the morning and evening meal.~     The subject will also be advised to call the clinic if there is an acute attack of cold and~     / or flu because they must then increase the in-take of study treatment to 3 double dose for~     5 days and then return to normal dose.~      The subject will then be asked a series of questions under study questionnaires, and be~     instructed in how questionnaires (SF-12) and diary filled. This is to provide security to~     the validation output values Investigator or study nurse will take telephone contact with~     the subject once a month, subjects will be asked about how things are going and to remember~     to take the liquid and whether they have completed the diary.~      The last patient visit will take place after 6 months. Any side effects will be reported to~     and reviewed with HybenVital ApS in collaboration with medical experts.~   "
121924|NCT01459939|"~     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase~     III study.~      After the patient has receiving information about the study and after given written informed~     consent, the patient will be screened. All patients are randomized to receive standardized~     rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose~     hip (or placebo) for the remaining 12 weeks of the study.~      The patient's medical history and demographic information will be recorded. The patient will~     then be asked questions in accordance to the study questionnaires, and they will also be~     asked to complete questionnaires regarding quality of life - and finally they be instructed~     on how to complete the diary.~      Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks~     of treatment, subjects will be asked about how things are going and to remember to take the~     capsules and whether they have completed the diary.~      The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the~     questionnaires including VAS scales.~      The last patient visit will take place after 12 weeks. Any side effects will be reported to~     and reviewed with HybenVital ApS in collaboration with medical experts.~   "
121925|NCT01459926|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety~     and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation~   "
121926|NCT01459913|"~     The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in~     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)~     (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC~     genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV)~     infection and will not have cirrhosis of the liver.~   "
121927|NCT01459900|"~     The purpose of this double blind, randomized and sham controlled study is to determine~     whether renal denervation in terms of catheter based ablation in the renal arteries is~     effective in lowering blood pressure in patients with treatment resistant hypertension. The~     blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure~     measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point~     evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and~     forearm plethysmography.~   "
121928|NCT01459887|"~     CD20, the protein which is expressed on the surface of all mature B cells, is active in many~     B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL),~     the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice,~     Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP)~     is still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric~     monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases.~     This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP~     chemotherapy regimen compared with CHOP chemotherapy alone.~   "
121929|NCT01459874|"~     The purpose of the registry is to evaluate an organizational model fixing roles and~     behaviors of subjects involved in the remote monitoring of patients implanted with~     pacemakers and defibrillators.~      The evaluation will estimate the clinical efficiency and the impact on health service~     resources of the organizational model when this is implemented in the daily clinical~     practice.~   "
121930|NCT01459861|"~     The purpose of this study is to assess early ambulation following total knee replacement in~     patients receiving continuous adductor canal block with posterior capsular injection~     compared to continuous femoral nerve block with tibial nerve block.~   "
121931|NCT01459848|"~     The investigators will do an experiment where 9-12 month old infants are randomized to 30~     minutes of block play or 30 minutes of watching a baby DVD.~   "
121932|NCT01459835|"~     This study tests the hypothesis that modifying the media diet of preschool children so that~     they watch more prosocial programming and less violent programming will result in decreased~     aggression and increased prosocial behavior.~   "
121933|NCT01459822|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which~     regulate mRNA expression. The present study was designed to observe the selected miRNA~     expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a~     new target for the treatment of sepsis.~   "
121934|NCT01459809|"~     Primary Objective:~      - To demonstrate the superiority of glimepiride and metformin free combination in comparison~     to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment~     period in patients with type 2 diabetes mellitus.~      Secondary Objectives:~      - To assess the effects of the free combination of glimepiride and metformin in comparison~     to glimepiride or metformin alone on:~        -  Percentage of patients reaching HbA1c < 7%~        -  Percentage of patients reaching HbA1c < 6.5%~        -  Fasting Plasma Glucose (FPG)~        -  Safety and tolerability~   "
121935|NCT01459796|"~     The purpose of this study is to determine the safety and tolerability of rilonacept for~     patients with gout who are initiating allopurinol.~   "
121939|NCT01459744|"~     An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest~     to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias~     when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of~     heart failure or other diseases. As patients near the end of life, physiologic changes~     (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to~     more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain~     and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider~     deactivating the shocking function of ICDs as patients' clinical status worsens and death is~     near. This will be a randomized controlled trial of a physician centered counseling and~     education intervention to improve clinician-patient communication about the management of~     ICDs.~   "
121940|NCT01459731|"~     Collect OCT data to evaluate the range and age trend of eye measurements.~   "
121941|NCT01459718|"~     The primary efficacy endpoint of this interventional study is to evaluate the number of~     patients achieving a complete response (CR), defined as patients switching from intensive~     deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox~     monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2* value~     to >10ms, and continue to maintain their MRI T2* to values >10 msec.~   "
121942|NCT01459705|"~     This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by~     comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment~     of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related~     trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE~     will successfully treat PTSD, therapeutically affect levels of physiological arousal, and~     significantly reduce perceptions of stigma toward seeking behavioral health services.~   "
121943|NCT01459692|"~     Neurologically-impaired individuals may have significant neurologic morbidity related to~     epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures,~     and potentially reversing the epileptogenic process, is of paramount importance in improving~     the lives of those with epilepsy. During a 3-year randomized, pilot clinical trial,~     twenty-seven subjects were randomly assigned to receive nightly exposure to music at~     periodic intervals between the hours of 9:00 PM and 8:00 AM. A significant effect was~     observed from the auditory stimulus exposure (p<0.006).~   "
121944|NCT01459679|"~     The objectives of this study are to evaluate and compare the safety and efficacy of three~     treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin~     ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing~     maximum corneal curvature.~   "
121945|NCT01459666|"~     Evaluate the efficacy and safety of using aboBTX-A to improve wound healing prior to Mohs~     micrographic surgery and reconstruction for skin cancer of the forehead~   "
121946|NCT01459653|"~     This international, prospective, observational, open-label, pharmaco-epidemiologic study~     observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are~     receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better~     describe the patient population at risk for FN and treated prophylactically in physician's~     best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis~     patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and~     variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy,~     surgery, and mortality. Additionally the study aims to identify patient cohorts who are~     vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN,~     understand the differences between prophylaxis responders and non-responders, and describe~     the degree to which prophylaxis of FN is in congruence with guideline recommendations.~   "
121947|NCT01459640|"~     Osteoarthritis is a progressively degenerative disease resulting in increasing pain,~     impairment and ultimately disability. While the available treatments seek to ameliorate pain~     or improve mobility, these treatments rarely modify the course of the disease, but rather~     attend to its consequences. For early stage osteoarthritis, treatment is largely limited to~     addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs).~     These drugs do not stop the progression of the condition or regenerates damaged cartilage.~      This is a randomized and open labelled study aimed to determine the efficacy of~     intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in~     patients with mild to moderate osteoarthritis.~   "
121948|NCT01459627|"~     OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet~     therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST~     elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical~     outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke~     and major bleeding at 18 months after randomization).~      The trial will incorporate two registers studying respectively the safety outcomes of~     Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30~     days. Finally the trial design permits assessment of the clinical outcomes after primary PCI~     for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent~     at 30 days and 6 months.~   "
121961|NCT01459458|"~     This is a community-based participatory study to test a brief intervention to reduce risk~     for intimate partner violence (IPV) and associated unintended pregnancy among young,~     medically underserved women attending family planning (FP) clinics. Women ages 16-29 years~     utilizing FP clinics report higher rates of IPV compared to their same-age peers,~     experiences associated with unintended pregnancy. A critical mechanism connecting IPV with~     poor reproductive health is abusive partners' control of women's reproduction through condom~     refusal, pressuring women to get pregnant, and birth control sabotage, a phenomenon~     described as reproductive coercion. In the investigative team's pilot intervention study 53%~     of young women using FP clinics reported ever experiencing IPV, and 25% reported~     reproductive coercion, the combination of which was strongly associated with unintended~     pregnancy. The proposed reproductive coercion/partner violence intervention was developed~     collaboratively by community-based practitioners, advocates, and researchers, with~     significant input from FP clients. Designed to be implemented within routine FP care,~     maximizing feasibility and sustainability of this program, the intervention provides 1)~     client education and assessment regarding IPV and reproductive coercion; 2) discussion of~     harm reduction behaviors to reduce risk for unintended pregnancy and IPV victimization, and~     3) supported referrals to IPV victim services. This is a full-scale RCT to assess the~     effects of this innovative program on IPV, reproductive coercion and unintended pregnancy,~     major health threats for medically underserved women. Evaluation of this intervention will~     involve random assignment of 25 FP clinics (unit of randomization) in Western PA to either~     intervention or control (i.e., standard-of-care) conditions. Female FP clients ages 16-29~     (N=3600) will be assessed at baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess~     intervention effects on knowledge and behaviors related to IPV, reproductive coercion and~     related harm reduction, as well as unintended pregnancy. Data will be collected via audio~     computer-assisted self-interview in English or Spanish. Chart extraction will track clinic~     utilization, pregnancy testing, and diagnosed pregnancies. Regression models appropriate for~     longitudinal data from cluster-randomized trials will be used to estimate intervention~     effects.~   "
121949|NCT01459614|"~     Primary Objectives~      To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with~     cisplatin in subjects with metastatic pancreatic cancer based on the progression-free~     survival (PFS) rate at 6 month.~      Secondary Objectives~        -  To assess safety and characterize toxicities of the combination of GTX with cisplatin~          in subjects with metastatic pancreatic cancer.~        -  To estimate 3, 6, 9, 12, 15, and 18 month disease control rate (DCR), PFS, and overall~          survival (OS).~      Study Design~      This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in~     subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be~     enrolled, 28 in the initial cohort and 10 in the expansion cohort~      The study will have a safety run-in phase consisting of 6 subjects. To ensure that the~     combination is safe, the first six subjects will be treated at DL1 and observed for limiting~     toxicity for the first 2 cycles before continuation with further accrual. After the safety~     run-in, the study will be continuously monitored for adverse events.~      The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of~     subjects alive, free of disease progression at 6 months. The treatment regimen would be~     considered of insufficient activity for further study in this population if PFS rate at 6~     months is 50% or less, and the minimum required level of efficacy that would warrant further~     study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes~     interim monitoring for futility using a predictive probability approach. We will stop the~     study early if given the information at the interim analysis, it is unlikely that the PFS~     rate at 6 months will be greater than 50% if the study continues to the end.~   "
121950|NCT01459601|"~     Diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months~     and their blood glucose is evaluated.~   "
121951|NCT01459588|"~     This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation~     in subjects with dry eye disease.~   "
121952|NCT01459575|"~     This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy~     of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese~     resource-limited setting.~   "
121953|NCT01459562|"~     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic~     profiles of a novel therapeutic drug when administered to healthy volunteers.~   "
121954|NCT01459549|"~     The purpose of this study is to determine whether Roux-en-Y choledochojejunostomy is a more~     effective treatment for the hepatolithiasis patients accompanied with Sphincter of Oddi~     Loose.~   "
121955|NCT01459536|"~     Adequate upper limb function is critically important to maintenance of independence and~     prevention of disability in older adults. The goal of this work is to identify factors that~     contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the~     investigators seek to identify patients most at risk for rupture and to guide clinicians on~     optimal surgical and rehabilitation strategies. This pilot study will quantitatively~     characterize the morphological (muscle volume and fatty infiltration) and functional~     (shoulder isometric joint strength, movement when performing typical task) changes in the~     muscles of the rotator cuff following supraspinatus tear and surgical repair. The~     investigators hypothesize that patients with supraspinatus tear will have reduced muscle~     volume and increased fatty infiltration of rotator cuff muscles compared to their~     contralateral arm and age-matched controls, which will increase following surgery. The~     investigators further hypothesize that isometric joint strength in these individuals will be~     associated with muscle volume and the degree of fatty infiltration, and that older adults~     with a rotator cuff tear will use a restricted range of motion to accomplish functional~     tasks. This study emphasizes muscle function and composition with application to~     rehabilitation of upper limb function, which complements the theme of the Pepper Center.~   "
121956|NCT01459523|"~     Continuous peripheral nerve blocks (CPNB; also known as perineural catheters) provide~     target-specific pain control for a variety of surgeries. There has been increasing interest~     in the use of ultrasound guidance for regional anesthesia, and many techniques using~     ultrasound alone for perineural catheter insertion have been described. Catheters may be~     placed at various points along the brachial plexus (for upper extremity procedures) or in~     proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the~     optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement~     location per indication, for the majority of ultrasound-guided continuous peripheral nerve~     blocks remain unknown. This study will help provide important information related to optimal~     ultrasound scanning techniques and will help identify ways to improve the success rates,~     onset times, and analgesic effectiveness of these techniques for real patients undergoing~     surgical procedures.~   "
121957|NCT01459510|"~     The American Academy of Pediatrics recommends that parents receive anticipatory guidance~     about how to discipline their children as part of the well child visit. However, physicians~     provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP~     recommends that primary care providers encourage parent to use non-physical forms of~     discipline and discourage parents from using physical punishment. Educational resources are~     needed to help physicians routinely provide these important anticipatory guidance messages.~     In this study, consecutive parents were exposed to routine anticipatory guidance messages~     before the well child visit with the physician. After the clinic visit, parents were invited~     to participate in a research study to assess their attitudes about physical punishment and~     other discipline strategies. The key research question of this study is: Can a brief~     multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of~     physical punishment? The time frame of the study was June through August of 2010. Data was~     collected immediately after the clinic visit and 2-4 weeks post clinic visit.~   "
121958|NCT01459497|"~     The study is designed to determine whether an accelerated course of hypofractionated~     radiation therapy with daily image guidance and motion assessment/control will allow more~     effective treatment of poor performance status patients with stage II-III NSCLC, who would~     benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per~     fraction).~   "
121959|NCT01459484|"~     The main objective of the study is to assess the survival in patient with non metastatic~     osteosarcoma of the extremities treated with different chemotherapy protocols, according to~     the expression of ABCB1/P-glycoprotein~   "
121960|NCT01459471|"~     The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative~     complications. Staple line reinforcement (SLR) is strongly advocated.~   "
121962|NCT01459445|"~     The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone~     combined with metformin and weight loss by means of dietary intervention on the indices of~     endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum~     hsCRP,lipids,insulin resistance and body composition in young women with PCOS.~   "
121963|NCT01459432|"~     The main purpose of this study is to evaluate the duration of immunity after a booster dose~     of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does~     seroprotection persist beyond teenage years and into the early twenties? This is the age~     group which is most likely to carry the organism and to transmit it to other members of the~     population. If a booster dose of MenC vaccine given to adolescents does produce protective~     levels of antibody which persist into early adulthood, this would strengthen the case for~     such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a~     resurgence of the disease in the future.~   "
121964|NCT01459419|"~     The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is~     justified on the basis of scientific and medical reasons. There are data in multiple animal~     models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and~     induces regulatory T cells and immune-modulation as desired in clinical studies. These~     observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone~     induced the desired immune-modulation in terms of immunological markers for regulatory T~     cells and appropriate rises and declines in certain cytokine levels.~   "
121965|NCT01459406|"~     Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause~     bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in~     patients suffering from the irritable bowel syndrome (IBS). This may be because they are not~     well absorbed in the small intestine and cause water to be trapped in the bowel causing~     distension. Studies have shown that reducing the amount of these sugars in the diet can~     relieve these symptoms. There is some evidence that combining fructose and glucose can~     reduce the symptoms caused by fructose but just why is unclear. In this study, the~     investigators will use a non invasive medical imaging technique called magnetic resonance~     imaging (or MRI) to look at the behaviour of drinks containing these sugars in the bowels~     of healthy human volunteers.~      The investigators will give four different drinks: one beverage consisting of a very well~     absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a~     third which is a mixture of glucose and fructose, and a fourth consisting of several~     fructose subunits joined together (called fructan). The investigators will take MRI images~     of the stomach and intestines at intervals for 5 hours and compare these with the feelings~     of distension and bloating in our volunteers. The results will act as control for subsequent~     studies in IBS patients and these may help design diets to reduce symptoms in IBS.~   "
121966|NCT01459393|"~     This study aims to compare in a prospective and randomized way actinic keratosis treatment~     with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of~     therapeutic efficacy, pain, and cosmetic results.~   "
121967|NCT01459380|"~     This phase I trial studies the side effects and the best dose of veliparib when given~     together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in~     treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer~     that has returned after previous treatment. Veliparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor~     cells by, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by~     blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth~     of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving~     veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and~     bevacizumab may kill more tumor cells.~   "
121968|NCT01459367|"~     The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared~     to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine~     the clinical dose.~   "
121969|NCT01459354|"~     Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable,~     distressing sequelae after tracheal intubation. It was postulated that these effects are~     because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to~     improve visual field during intubation. This procedure might reduce laryngeal trauma during~     intubation and therefore reduce the incidence or degree of post-operative sore throat. This~     is the first prospective, double-blinded, controlled study, which is focused on the effects~     of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).~   "
121970|NCT01459341|"~     Comparison of two non-invasive methods for measuring tissue oxygenation. One is~     Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared~     Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia~     (CLI) undergoing invasive treatment (surgical or endovascular).~   "
121971|NCT01459328|"~     This is a prospective, multicentre, randomized clinical trial comparing two different~     neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced~     adenocarcinoma of the rectum.~      This trial may establish the investigational therapy to be superior to, or at least not~     inferior to conventional treatment.~   "
121972|NCT01459315|"~     The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid,~     rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of~     an investigational HIV medication known as GSK1349572 (dolutegravir).~   "
121983|NCT01459172|"~     The overall objective of this project is to determine the safety and breast tissue~     bioavailability of limonene following massage application of limonene containing massage oil~     to the breast.~   "
121984|NCT01459159|"~     This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®)~     in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q)~     Myelodysplastic Syndrome (MDS).~   "
121985|NCT01459146|"~     The purpose of this study is to determine if Artemisinin-based Combination Therapy,~     ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in~     combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and~     school sustained attention and concentration.~   "
121973|NCT01459302|"~     The investigators laboratory has been studying families with a history of ALS for more than~     25 years and is continuing to use new ways to understand how genes may play a role in ALS,~     motor neuron disease and other neuromuscular disorders.~      The purpose of this study is to identify additional genes that may cause or put a person at~     risk for either familial ALS (meaning 2 or more people in a family who have had ALS),~     sporadic ALS, or other forms of motor neuron disease in the hopes of improving diagnosis and~     treatment. As new genes are found that may be linked to ALS in families or individuals, the~     investigators can then further study how that gene may be contributing to the disease by~     studying it down to the protein and molecular level. This includes all forms of ALS, motor~     neuron disease and ALS with fronto-temporal dementia(ALS/FTD). We also continue to study~     other forms of neuromuscular disease such as Miyoshi myopathy, FSH dystrophy and other forms~     of muscular dystrophy by looking at the genes that may be associated with them.~      There have been a number of genes identified that are associated both familial and sporadic~     ALS, with the SOD1, C9orf72, and FUS genes explaining the majority of the cases. However,~     for about 30% of families with FALS, the gene(s) are still unknown.~      The investigators also will continue to work with families already identified to carry one~     of the known genes associated with ALS.~   "
121974|NCT01459289|"~     The use of HPV testing in cervical screening has raised concerns about the effect of a~     positive HPV result on women's psychological well being. This is a nested psychosocial study~     of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the~     psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects~     of educational intervention on such impact. Potential participants are identified among~     those who have joint the COCY trial. Participants will be randomized into two groups, namely~     the control group or intervention group. The control group participants will receive their~     smear results and an HPV leaflet by post. The intervention group will receive the leaflet~     and a counseling session on HPV. Self-administered questionnaires will be used to assess~     participants' psychological condition at the receipt of the smear results and at two months~     afterward. It is hypothesized that the level of emotional distress measured at smear result~     notification will be greater than that at two months afterward for all participants.~     Furthermore, participants in the intervention group will have lower psychological distress~     than those in the control group at two months after the receipt of their smear results.~   "
121975|NCT01459276|"~     The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL~     intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA~     of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.~   "
121976|NCT01459263|"~     More than 25 percent of the general population suffers from varicose veins, which has a~     considerable impact on quality of life. Nowadays endovenous treatment modalities for great~     saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new~     tumescent-less technique, that combines mechanical endothelial damage using a rotating wire~     with the infusion of a liquid sclerosant. The current study aims at evaluating short and~     long term outcome after mechanochemical endovenous ablation.~   "
121977|NCT01459250|"~     This study will assess the pharmacokinetics, safety and tolerability of a single dose of~     AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease~     with that in healthy matched control subjects.~   "
121978|NCT01459237|"~     Background:~        -  Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about~          the size of a pea located at the base of the brain. These tumors produce high levels of~          hormones, which cause obesity, diabetes, and growth problems. The cure for this type of~          Cushing s disease is to have surgery that removes the tumor but leaves the pituitary~          gland alone. Currently, magnetic resonance imaging scans are the best way to find these~          tumors. However, many of these tumors do not show up on the scan.~        -  Positron emission tomography (PET) scans use radioactive chemicals to light up parts of~          the body that are more active, such as tumors. Researchers want to try to make the~          small Cushing s disease tumors more active to help them show up on the scans. A special~          hormone will be given before the scan to make the tumors more active.~      Objectives:~      - To test the use of hormone stimulation to improve brain scans for Cushing s disease~     tumors.~      Eligibility:~      - Individuals at least 8 years of age who will be having surgery to remove Cushing s disease~     tumors.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  They will have three brain scans before surgery. The first scan is a magnetic resonance~          imaging scan to show a full picture of the brain. The second and third scans are PET~          scans.~        -  The first PET scan will be given without the special hormone. The second PET scan will~          be done more than 24 hours but less than 14 days after the first PET scan. The second~          PET scan will be given with the special hormone.~        -  Participants will have tumor removal surgery through another study protocol.~   "
121979|NCT01459224|"~     Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at~     diagnosis and initial treatment response assessment. At each time point (initial staging and~     treatment response assessment) in addition to standard imaging investigations (PET CT, Chest~     CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an~     extended MRI scan.~   "
121980|NCT01459211|"~     The purpose of this study is to establish the safety and efficacy of a combination of~     dexamethasone and lenalidomide (Revlimid®) (D+L) in subjects with relapsed or refractory CLL~     who have failed or are unable to tolerate standard up-front therapy with regimens containing~     Fludarabine or in those with mutations in the p53 gene, CAMPATH-1H.~   "
121981|NCT01459198|"~     Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract~     illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and~     pneumonia. RSV affects almost all children within the first 2 years of life. This study will~     evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults,~     RSV-seropositive children, and RSV-seronegative infants and children.~   "
121982|NCT01459185|"~     The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine~     S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small~     cell lung cancer. The investigators presume they can achieve high completion rate with low~     toxicity.~   "
121986|NCT01459133|"~     The purpose of this program is to allow patients with diabetes and with specific medical~     needs which require them to use this investigational inhaled insulin product in order to~     adequately manage their diabetes. Treatment use of this investigational product is only~     anticipated when exceptional need is identified by a treating physician on a per patient~     case by case review.~   "
121987|NCT01459120|"~     The purpose of this trial is to determine if door-to-door is more effective than community~     gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural~     Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of~     a package of proposed services. The package consists of: Blood-pressure measurement,~     blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up~     vaccinations, deworming (children) Vitamin A (children & young women), family planning for~     eligible women, Tuberculosis screening and HIV counseling and testing.~   "
121988|NCT01459107|"~     Background: Millions of people each year sustain injuries, have tumors surgically removed,~     or are born with defects that require complex reconstructive surgeries to repair. In the~     case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor~     function and no sensory feedback. However, hand and arm transplantation is a means to~     restore the appearance, anatomy, and function of a native hand. Although over 70 hand~     transplants have been performed to date and good functional results have been achieved,~     widespread clinical use has been limited due to adverse effects of life-long and high-dose~     immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and~     metabolic problems, all of which can greatly affect recipients' quality of life, make the~     procedure riskier, and jeopardize the potential benefits of hand transplantation.~      Study Design: This non-randomized, Phase II clinical trial will document the use of a new~     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand~     transplantation as a safe and effective reconstructive treatment for upper extremity~     amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral~     hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor~     bone marrow cell infusion and has enabled graft survival using low doses of a single~     immunosuppressive drug followed by weaning of treatment. Initially designed for~     living-related solid organ donation, this regimen has been adapted for use with grafts~     donated by deceased donors. The investigators propose to perform 30 human hand transplants~     employing this novel protocol.~      Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive~     strategy for the treatment of upper extremity amputations; 2) To reduce the risk of~     rejection and enable allograft survival while minimizing the requirement for long-term high~     dose multi-drug immunosuppression.~      Significance of Research: Hand transplantation could help upper extremity amputees recover~     functionality, self-esteem, and the capability to reintegrate into family and social life as~     whole individuals. The protocol offers the potential for minimizing the morbidity of~     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this~     life-enhancing procedure and enabling widespread clinical application of hand~     transplantation.~   "
121989|NCT01459094|"~     The purpose of this study is to see if the absorption and distribution of a fixed-dose~     Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food~     by healthy volunteers.~   "
121990|NCT01459081|"~     The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir~     in treatment of influenza A and B virus infections in China.~   "
121991|NCT01459068|"~     The aim of the study is to determine the effectiveness of a transdiagnostic psychotherapy~     intervention - namely, Common Elements Treatment Approach (CETA) - in reducing the severity~     of mental health symptoms experienced by torture and violence survivors displaced from Burma~     into Thailand. Specifically, the intervention seeks to measure reductions (if any) in~     symptoms of depression and trauma.~   "
121992|NCT01459055|"~     Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal~     digits, periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies~     vitiligo as generalized or localized; generalized vitiligo may be further sub-divided into~     acrofacial, vulgaris and universalis, and localized vitiligo, into segmental and focal. Some~     authors do not believe that acrofacial is a real vitiligo clinical form, considering it as~     an initial form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed~     acrofacial patients during ten years in order to define if these patients will maintain this~     clinical form or will evolute to a more severe clinical form.~   "
121993|NCT01459042|"~     Recent studies indicate that primary aldosteronism (PA) is a much more common cause of~     hypertension than had been demonstrated historically. In patients with resistant~     hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has~     been no such data in China, the investigators are conducting a PA study in different~     province of China to evaluate the prevalence of PA in patients with resistant hypertension.~   "
121994|NCT01459029|"~     The purpose of this study is to compare efficacy and safety of add-on treatment with a~     moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset~     schizophrenia patients who suffer from significant symptoms despite treatment with~     antipsychotics.~   "
121995|NCT01459016|"~     This study will investigate the volume, function and composition of the brain using magnetic~     resonance imaging (MRI) and positron emission tomography (PET) scanning technology in~     participants with memory complaints or early signs of Alzheimer's pathology.~   "
121996|NCT01459003|"~     Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer~   "
121997|NCT01458990|"~     The purpose of this study is to find out whether the use of medications that suppress acid~     in your stomach can change the composition of your bowel bacteria.~   "
121998|NCT01458977|"~     This is a phase IV, multicenter, prospective, randomised, crossover, double blind,~     placebo-controlled and proof of concept clinical trial.~      All subjects fulfilling inclusion criteria will be randomised to add either TDF/FTC~     co-formulation (group A) or placebo (Group B) to their current PI/r regimen, i.e.: DRV/r~     800/100 mg QD or LPV/r 400/100 BID. This will be followed by a crossover addition of TDF/FTC~     co-formulation or placebo.~      Randomization will be centralised in the CRO FLS-Research Support and will be stratified by~     DRV/r or LPV/r intake at baseline to ensure equal distribution in both arms. TDF/FTC~     co-formulation or Placebo will be provided in a double-blinded fashion, i.e.: neither the~     treating physician nor the patient will know whether the patient is receiving TDF/FTC or~     placebo.~      All subjects will receive dietary counselling to promote lipid-lowering diet provided by a~     specialised dietician throughout the study.~      The expected duration of the study for each participant will be 36 weeks. There will be 6~     visits: screening, baseline and weeks 4, 12, 24 and 36.~   "
121999|NCT01458964|"~     Is quetiapine more effective than other medications in the treatment of fibromyalgia.~   "
122000|NCT01458951|"~     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in~     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one~     of following treatments for ulcerative colitis: oral steroids,~     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.~   "
122001|NCT01458938|"~     The objective of this pilot study is to determine if degenerative spinal disorders such as~     acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable~     alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot~     study shows a correlation between Substance P levels and pain associated with degenerative~     spinal disorders, then a larger study will be initiated to determine the feasibility of~     using Substance P levels in the diagnosis and treatment of degenerative spinal disease.~   "
122002|NCT01458925|"~     Prospective, Single arm, Multi-Center~        1. To establish the safety and preliminary efficacy of the Check-Cap System in patients~          with negative FOBT (Fecal Occult Blood Test)~        2. To collect data about the overall imaging of the colon internal surface during the~          passage of the capsule~        3. To develop a correlation map between the imaging of the polyps by optical colonoscopy~          vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps~          by CT Colonography [CTC] (in patients which were referred after positive CTC~          examination)~   "
122003|NCT01458912|"~     The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium~     doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week~     treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low~     dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory~     Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an~     Asthma Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.~   "
122004|NCT01458899|"~     (Food versus no food) crossover study to measure the effects of food on pharmacokinetics of~     TC-5214 (S-Mecamylamine) in healthy Subjects.~   "
122005|NCT01458886|"~     The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of~     very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over~     an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately~     controlled on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease~     in forced expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less~     than 25%) and an Asthma Control Questionnaire (ACQ-6) of not less than 1.5 at time of~     randomisation.~   "
122006|NCT01458873|"~     Vascular access in patients carries a significant risk of accidental extravasation of~     intravenous (IV) fluids and medications with the potential for tissue injury. This~     prospective controlled study assessed the diagnostic utility of using intravenous diluted~     sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium~     bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal~     carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the~     injected bicarbonate will dissolve into carbon dioxide and water and cause a transient~     increase in the measured exhaled CO2.~      The effect is unique to bicarbonate and will not appear once normal saline is injected. the~     safety of the administration of bicarbonate on the metabolic profile of the volunteers will~     be assessed by measurement of venous blood pH and electrolytes.~   "
122007|NCT01458860|"~     Atherosclerosis is the major contributor for the morbidity and mortality for the variety of~     cardiovascular diseases.~      Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent~     prognostic factor for the morbidity and mortality from a cardiovascular event.~      Carotid artery stenoses is the current accepted indication for interventional treatment of~     carotid artery, for the prevention of embolic event, while other arterial atherosclerosis~     indication, is for hemodynamic disturbance and ischemic outcome.~      This research will try to find whether incidental aortic calcification can predict carotid~     artery stenosis.~      Two groups will be chosen: group A - patients who had CT scan in the hospital (for different~     indications); Group B - patients (not from the first group) who have a significant carotid~     artery stenosis who are indicated for interventional treatment.~      The data to analyze:~      Group A - Patients with aortic calcification, carotid artery stenosis, and patients with~     both Group B - Patients who have aortic calcification Comparison of the populations within~     the group and among the two will show if a significant correlation between aortic~     calcification and carotid artery stenosis exist.~   "
122008|NCT01458847|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of~     intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive~     bladder cancer.~   "
122009|NCT01458834|"~     Several studies indicate that cigarette smokers show an attentional bias for~     cigarette-related cues, meaning that they more quickly detect and attend to and have more~     difficulty disengaging in cigarette-related information than neutral information. This bias~     is associated with craving and relapse following attempts to quit. This experiment will~     examine whether a computerized attentional training procedure will successfully reduce~     attentional bias towards smoking cues and reduce craving in regular cigarette smokers. The~     attentional training will be administered in a novel format in which participants complete~     5-minute long training sessions 3 times per day and can complete the trainings via home~     computer or handheld device such as the iPhone, Android phone, or iPod touch. A baseline~     assessment in the laboratory will measure attentional bias to smoking cues and craving~     following smoking cue exposure. Participants will then be randomly assigned to either the~     active training condition or a control condition. In both conditions, participants will be~     asked to complete brief training sessions 3 times daily for one week using their personal~     computer or handheld device. Following one week of training, participants will return to the~     lab for endpoint assessment of attentional bias and craving. The investigators hypothesize~     that compared to the control condition, the active training condition will significantly~     reduce attentional bias toward smoking related cues and cue-induced cigarette craving.~   "
122010|NCT01458821|"~     The purpose of this research study is to determine whether the Brain Fitness~     Program-Tinnitus affects how tinnitus is perceived and if its use aids in the recovery of~     cognitive functions that may be affected by tinnitus. The investigators hope to better~     understand areas of the brain involved with or changed because of tinnitus. The~     investigators also hope to see if the Brain Fitness Program-Tinnitus impacts changes in~     those areas of the brain the investigators believe may be affected by tinnitus.~   "
122212|NCT01456156|"~     Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some~     patients can not receive radical resection. Such patients have high risk of recurrence.~     Tumor resection and postoperative radiation is an option for such patients to achieve~     radical treatment and radiation may reduce local recurrence.~   "
122011|NCT01458808|"~     Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and~     inflammatory state in hemodialysis (HD) patients.~      Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical~     School Hospital, Sao Paulo State University, Brazil.~      Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl~     were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium~     restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical,~     hematological and nutritional markers, as well as dialysis dosage were assessed at baseline~     and after 8 and 16 weeks.~   "
122012|NCT01458795|"~     The aim of this study is to evaluate the morphologic and hemodynamic changes in the calf~     perforators after endovenous laser ablation of saphenous veins.~   "
122013|NCT01458782|"~     ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte~     Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of~     cartilage defects in the knee.~      Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are~     planned to include in this study.~      Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI~     includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in~     Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the~     ChondroGide membrane.~      The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture~     and cover of the defect using the same ChondroGide membrane.~      In both groups stitches and fibrin glue will be used to fix the membrane.~      Inclusion criteria:~      Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size~     more than 2 square cm.~      Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint~     disease, Serious illness~      Preoperative examination and follow up: Clinical examination and registration of KOOS (a~     validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of~     the involved knee including weightbearing standing radiographs of both knees. Kellgren-~     Lawrence classification will be used for grading of OA.~      Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients~     having a new cartilage resurfacing operation or prosthesis will be listed as failures of the~     initial treatment.~      Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for~     the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive~     cell cultivation and two surgeries).~      Data will be analyzed using the SPSS statistical package.~   "
122014|NCT01458769|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     isotopologs of Atazanavir both as single agents and as combinations.~   "
122015|NCT01458756|"~     Organ transplantation has a special place in the medical field. It symbolizes a medicine~     whose limits always seem to be repelled. Because transplantation is unusual, it places~     people in front of outstanding issues which he has to cope with his personality and history.~     Factors involved in the psychology of patient presenting with graft are past and present~     psychic functioning, object relations, experience of transplantation itself and quality of~     social environment.~      Before or after graft defense mechanisms can be so intense that they can make the patient~     unable to overcome the graft. Yet as a pathological mechanism that denial was considered~     beneficial provided it is short.~      The aim of this study is to evaluate on psychopathological influence of psychological~     defense mechanisms used by liver transplant patients on their somatic psychological and~     social outcome.~   "
122016|NCT01458743|"~     The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of~     ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.~   "
122017|NCT01458730|"~     The purpose of the study is to test the efficacy and tolerability of a multiagent~     chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed~     lymphoma in the brain.~   "
122018|NCT01458717|"~     Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline~     resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III~     study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable~     pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other~     with neoadjuvant chemoradiation therapy.~   "
122019|NCT01458704|"~     Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome~     sequencing) will be performed from fresh frozen tumor samples to understand the genetic~     alteration of tumors and to aid in optimal selection of further therapeutic agents.~   "
122020|NCT01458691|"~     The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet~     Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the~     shoulder.~   "
122021|NCT01458678|"~     Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is~     administered to the patient during contemporary measurement of the patients stroke volume.~     The fluid status is considered optimized when stroke volume no longer increases with more~     than 10%, indicating that the patient is close to the top of the Frank-Starling curve.~     Several studies show that volume optimization reduces hospital stay and reduces the amount~     of surgical complications. The overall purpose is to investigate if the much more simple non~     invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume~     therapy in routine health care, and to analyse if a volume kinetic test can be used to~     evaluate hypovolemia before surgery and make specific rehydration possible by analysing the~     correlation between this test and fluid optimization using stroke volume measurements.~      Primary hypothesis: 1. The volume of colloids that is given to volume optimise an~     anesthetized patient using Pleth Variability Index shows a good correlation to the volume~     used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data~     from the two methods correlate and discriminates similarly volume responders from non~     responders. 3. A volume kinetic model that indicates dehydration can predict the need for~     rehydration in order to achieve a well hydrated patient at start of surgery.~   "
122022|NCT01458665|"~     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator~          cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in~          treatment of medium to large rotator cuff tears.~        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after~          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall~          satisfaction, and enhance structural integrity of repaired tendon.~   "
122033|NCT01458522|"~     This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV~     fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse~     Events profile of LCM compared with fPHT when used to treat frequent NCSs, and length of~     stay in an intensive care unit for subjects treated with LCM versus subjects treated with~     fPHT. The trial will include a preacute-treatment period, an acute-treatment period, a~     postacute-treatment period, and a long-term follow-up period.~   "
122023|NCT01458652|"~     Accumulating evidence suggested that increased oxidative stress (OxSt) as well as~     inflammation are risk factors for cardiovascular events in hemodialysis patients. The~     incremental effect of online haemodiafiltration (OL-HDF) on markers of microinflammation~     ,and OxSt is less clear. Besides, the relationship between protein-bind uremic toxin and~     microinflammation remains obscure. The aim of this study was to evaluate the effect volume~     replacement of on-line hemodiafiltration on proinflammatory peripheral monocytes (percentage~     of CD14+CD16+ cells), PAF, IL-6 and on the plasma level of several oxidative stress markers~     as well as several protein-bound uremic toxins such as p-cresol, indole sulfate etc. In a~     case controlled study, 30 patients on OL-HDF will be evaluated. The association between~     protein-bound uremic toxins such as p-cresol, indole sulfate etc and AST-120, a spherical~     adsorptive carbon preparation (Kremezin) will also being investigated.~   "
122024|NCT01458639|"~     Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin~     (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA)~     imaging for the diagnosis of Pulmonary Embolism (PE).~   "
122025|NCT01458626|"~     Although treatment guidelines manifest that antidepressant response usually appear with a~     delay of several weeks and suggest that treatment should be changed if a partial response~     has not occurred after 4~6 week, these beliefs are no longer held by experts, and a new~     concept is raised that the first 2 weeks of treatment may be a useful strategy for improving~     the management of depression. New evidence indicates that early treatment response can be~     predicted with high sensitivity after 2 weeks of treatment in patients with major depressive~     disorder (MDD).~      Early improvement not only predicted response or remission, but also that lack of~     improvement was associated with little chance of response if the treatment strategy remained~     unchanged. The criterion of a 20% score reduction has been chosen as an early indicator of~     improvement because it can be reliably measured in clinical trials and translates into a~     clinically relevant change in the severity of depressive symptoms.~      Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be~     more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy~     of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant,~     the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has~     been suggested to have a faster onset of action than SSRIs in MDD patients.~      The aim of this study is to provide physicians with further information regarding early~     improvement and the effectiveness of mirtazapine combined with a SSRI antidepressant therapy~     in nonresponders.~   "
122026|NCT01458613|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Maroteaux-Lamy dis-ease from plasma and sputum~   "
122027|NCT01458600|"~     AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease~      Background - Already at diagnosis of Graves disease approximately 98% of the patients have~     morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors~     known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting~     observation is that a patient with stable and inactive Graves´ disease developed~     ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been~     shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones~     are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma~     in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like~     indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins~     which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J.~     Inflammation and adipogenesis are hallmarks of the pathological process in Graves~     ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study~     demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue~     symptoms, eye muscle symptoms and eye protrusion.~      Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of~     ophthalmopathy.~      Specific aims:~        1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months~          treatment with or without diclofenac.~        2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy~          after 12 months treatment with or without diclofenac.~        3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months~          treatment with or without diclofenac.~      Study plan and randomisation -~      150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with~     anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18~     months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12~     months.~   "
122028|NCT01458587|"~     The purpose of this study is to determine if Levulan PDT is safe and effective in the~     treatment of actinic keratoses on the upper arms and hands.~   "
122029|NCT01458574|"~     The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and~     tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes~     to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively~     achieves mucosal healing and improves quality of life in subjects with UC.The study proposes~     to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over~     the age of 18 years with UC.~   "
122030|NCT01458561|"~     This is a prospective, multicenter, randomized, controlled investigation. Subjects in which~     bleeding from the exposed parenchymal surface is observed intraoperatively following the~     ligature of vessels visible with the unaided eye will be randomized to an adjunctive~     application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the~     form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment~     of the exposed parenchymal surface as prescribed by the randomization scheme, treatment~     sites will be visually evaluated for the continued presence of bleeding. The overall~     objective of this investigation is to collect clinical data concerning the safety and~     effectiveness of BioFoam used as an adjunct to conservative measures of achieving~     hemostasis, such as manual pressure, cautery, and ligation, for intraoperative capillary,~     arteriolar, and venular bleeding (5 second stack of 5 gauze surface Bleeding Score = 1b or~     2, score to be validated) on newly resected liver parenchyma in hemodynamically stable~     (American College of Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and~     non-coagulopathic patients in the open treatment of exposed liver parenchyma versus a~     standard topical hemostatic agent, Gelfoam Plus. It is not intended for traumatic liver~     injury. The investigation will be conducted at a maximum of three investigational sites.~   "
122031|NCT01458548|"~     Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of~     transplant recipients and can be EBV-associated. To improve long-term efficacy after~     rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the~     investigators initiated an international multicentre phase II trial to test whether the~     subsequent application of rituximab and four courses of three-weekly CHOP would improve the~     outcome of patients with PTLD: PTLD-1, sequential treatment (ST).~   "
122032|NCT01458535|"~     The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of~     ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve~     participants with genotype 1, 2 or 3 chronic HCV infection.~   "
122034|NCT01458509|"~     It can be difficult to obtain the perspective of patients who have had bowel surgery. This~     study is being done because the investigators are trying to find out whether~     patient-reported outcomes, (results reported to investigators by the patient), on a regular~     basis, will help the investigators provide better patient care and symptom management.~      Therefore, the purpose of this study is to determine if it is possible and if it is useful~     to their medical care for patients who have had bowel surgery to complete surveys about~     their symptoms on a regular basis. In this study the surveys are completed from home, by web~     or by telephone, every month for 6 months. The results of this study will guide the design~     of large research studies on cancer-related bowel function.~      The purpose of this study is to develop a bowel function questionnaire for patients with~     colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel~     function.~   "
122035|NCT01458496|"~     A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes)~     but without pre-existing cardiovascular disease will effectively help participants change~     their lifestyle behaviour and prevent or delay onset of cardiovascular disease.~   "
122036|NCT01458483|"~     The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter,~     prospective, non-randomized study that is being conducted to evaluate the feasibility of~     endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter~     advanced into the internal jugular vein (IJV). The current study investigates the hypothesis~     that intraoperative electrical stimulation of the carotid sinus from the IJV will result in~     an acute and dose-dependent reduction in blood pressure and heart rate.~   "
122037|NCT01458470|"~     Huntington disease is characterized by difficulties in movement and thinking. Psychological~     disturbances including irritability, aggression, loss of interest, depressed mood,~     obsessions and compulsions, also represent common symptoms of HD. These symptoms are~     distressing both for HD patients and their caregivers, contribute to the loss of ability to~     carry out activities of daily living, and present a major treatment challenge for~     physicians. The goal of this study is to determine the effect of memantine on movement,~     thinking and emotional difficulties in HD patients. Memantine is a medication originally~     approved for the treatment of aggression and agitation in patients with moderate-to-severe~     Alzheimer's disease (AD), which has also recently been shown to improve the behavioural and~     neuropathological symptoms in a mouse model of Huntington Disease (HD).~   "
122038|NCT01458457|"~     Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease~     specific quality of life of an individualized additional complementary medicine treatment in~     addition to usual care with usual care only in 280 women with breast cancer~   "
122039|NCT01458444|"~     The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place~     in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the~     use, in the immediate postoperative period, should lead to define the role of each technique~     and lead to a optimal rationalization of patients management with acute respiratory failure~     after surgery.~   "
122040|NCT01458431|"~     The postoperative period following cesarean is associated with moderate to severe pain that~     requires a considerable amount of analgesics that carry with them side-effects such as~     nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable~     results, to find a more effective analgesia alternative such as infusion of local~     anesthetics through a catheter in the surgical wound sinus, a practice that has currently~     been widely used in clinical practice. Despite existing references on its use in the~     postoperative period following cesareans there continues to be a lack of information on~     other aspects. The investigators study hypothesis is that the use of levobupivacaine in the~     surgical wound will reduce the surface of hyperalgesia compared to the control group.~   "
122041|NCT01458418|"~     Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights~     infection) travel to the esophagus (the tube through which food passes to the stomach).~     These cells do not belong there and can cause pain, soreness, difficulty swallowing and~     sometimes vomiting.~      Ways to treat this condition include medicine, not eating some foods, and drinking a~     specific formula (like milk) without eating any other foods. Doing these things can help~     fight off EE but these problems can come back when treatment is stopped. If EE symptoms go~     on for a long time, it can lead to the esophagus becoming narrow and feeling tight when~     eating and swallowing and surgery may be needed to widen the narrowed area to relieve the~     sensation of tightening.~      Montelukast is a medicine that fights off a type of chemical that can be a magnet for~     eosinophils. People usually take this medicine to help treat their asthma. It is not~     approved to treat EE. This medication is taken once a day.~      The purpose of this study is to see if Montelukast, compared to placebo, will help reduce~     the number of eosinophils in children with EE and help stop the tightening of the esophagus.~   "
122042|NCT01458405|"~     The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells~     (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial~     infarction.~   "
122043|NCT01458392|"~     Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied~     in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks~     the development of blood vessels that supply tumors.~   "
122044|NCT01458366|"~     The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to~     define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of~     bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma~     whose disease has progressed or has recurred after prior chemotherapy.~      The Phase II part of the study will be a single-arm, open-label study in which all patients~     will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose~     defined in phase I.~      This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's~     Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The~     hypothesis is that the proposed combination of chemotherapy is well-tolerated and is~     efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.~   "
122069|NCT01458041|"~     Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical~     limb ischemia by recording clinical parameters.~   "
122213|NCT01456143|"~     This study examines if certain imaging techniques and devices can aid the surgeon in~     detecting cancer during the surgical procedure.~   "
122045|NCT01458353|"~     Despite performing colonic surgery with strict asepsia measures, minimizing the contact of~     the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In~     stapled anastomosis, the hole opened in the colon is minimum, just the necessary for~     introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen~     is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the~     suture is performed.~      Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than~     after handsewn ones.~   "
122046|NCT01458340|"~     The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be~     evaluated in adult males with ADHD.~   "
122047|NCT01458327|"~     This study will consist of a single session of MDMA-assisted psychotherapy with a full dose~     of MDMA for people who took part in a study of MDMA-assisted psychotherapy in people with~     posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least~     a year after the first MDMA sessions. The single session will be performed by the same pair~     of therapists who performed the sessions in the first study. People will have a preparatory~     session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD~     symptoms and symptoms of depression will be measured at the start of this study and two and~     12 months after the session.~   "
122048|NCT01458314|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory~     insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies~     performed in these patients during a unique session of training have shown a positive effect~     on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during~     incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI~     patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV~     during arm effort test improved ability to perform the exercise. Similar result was not~     reached using NIV during walking. Further studies have underlined a positive effect of the~     ventilation therapy during exercise within specific programs of pulmonary rehabilitation~     (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD~     patients may produce greater benefits in exercise tolerance and quality of life than~     exercise training alone (Garrod 2000).~      A great improvement in health-related quality of life, functional status and gas exchange in~     COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with~     patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008).~     However, in the same study Duieverman did not show any significant difference between groups~     in terms of tolerance to effort test.~      Aim of the study is to evaluate if application of daily NIV during physical training may~     increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with~     patients with nocturnal NIV performing training under spontaneous breathing.~   "
122049|NCT01458301|"~     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily~     (QD), for 12 weeks in women with endometriosis.~   "
122050|NCT01458288|"~     This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell~     Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple~     Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.~   "
122051|NCT01458275|"~     This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,~     efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and~     premenarchal female subjects 6 to 11 years-old diagnosed with SAR.~   "
122052|NCT01458262|"~     The purpose of this study is to determine the clinical impact of cerebral and systemic~     desaturation during liver transplantation and resection on post-operative complications.~   "
122053|NCT01458249|"~     The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in~     subjects with soft tissue sarcoma who received at least one standard chemotherapy (an~     anthracycline or an ifosfamide monotherapy or a combination therapy).~   "
122054|NCT01458236|"~     A multinational, multicenter, double-blind, randomized, placebo-controlled, Phase III study~     to assess the efficacy and safety of BPS 314d-MR in subjects with pulmonary arterial~     hypertension currently receiving treatment with an Endothelin Receptor Antagonist (ERA)~     and/or a Phosphodiesterase-5 Inhibitor (PDE-5 inhibitor).~      Approximately 100 centers will be participating in the study. Approximately 630 eligible~     subjects will be randomized 1:1 into two groups, BPS-314d-MR (active) or placebo study drug.~   "
122055|NCT01458223|"~     Post-operative antibiotics for infection prophylaxis are routinely given to most surgical~     patients, and for orthopaedic surgery patients, the standard of care is treatment for 24~     hours following any elective procedure (1). The most concerning risk for insufficient~     antibiotic coverage in the post-operative period is the development of a complicated~     infection requiring irrigation and debridement or revision surgery. Moreover, recovery from~     surgery is usually delayed in patients that have postoperative wound infections leading to~     increased resource utilization and increased economic cost for the health care system. It is~     clear that prophylactic antibiotic therapy is necessary in the immediate post-operative~     period, but the length required continues to be debated.~      Orthopaedic patients undergoing elective spine surgeries often require the placement of a~     hemovac drain which applies gentle suction to remove excess fluid/blood and to promote~     healing. Wound drains, however, may also increase the risk of post-operative infection~     because they expose the clean interior aspect of the wound to the dirty exterior area~     around the wound. Given this additional focus of infection, it is unknown whether prolonged~     antibiotic therapy post-operatively is needed to decrease the rate of infection in this~     population (2,3). There is sparse literature evaluating the effectiveness of prolonged~     antibiotic therapy in decreasing complicated post-operative infection requiring irrigation~     and debridement in this population (1,4). To our knowledge, there are no recent studies~     comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after~     removal of the drain. In fact, a recent evidence-based review of the literature by the North~     American Spine Society highlighted the need for research in this area (5).~      The proposed study will compare two patient populations who will receive various lengths of~     post-operative antibiotics. One will receive only 24 hours worth, and the other will receive~     antibiotics for 72 hours after surgery and the rate of complicated infection compared~     between the two.~      The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24~     hours immediately post-operatively is sufficient for all elective spine patients undergoing~     posterior spine procedures requiring the placement of a hemovac drain.~   "
122056|NCT01458210|"~     The purpose of this study is to look at how the body processes oral contraceptive (OC),~     using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy~     female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the~     body. Information about any side effects that may occur will also be collected.~   "
122057|NCT01458197|"~     1. Primary Objective:~           To evaluate the dose-response relationship of tarafenacin on efficacy.~        2. Secondary Objectives:~             -  To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo~               in patients suffering from Overactive Bladder. .~             -  To compare the tolerability of different doses of tarafenacin to that of placebo~               in patients suffering from Overactive Bladder. .~   "
122234|NCT01455870|"~     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin~     monotherapy in patients with type 2 diabetes.~   "
122058|NCT01458184|"~     The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex~     Patients (TLC-C) in the care of patients with complex health care needs. These are patients~     frequently transitioning from inpatient to ambulatory care with multiple chronic diseases~     that tend to lead to increased health-care utilization and other socio-economic~     vulnerabilities. The objective is to reduce preventable hospital utilization, improve~     quality of life, increase satisfaction with ambulatory care, improve disease-specific~     metrics, and reduce net payer costs.~   "
122059|NCT01458171|"~     The objective of this study is to assess the long-term safety, tolerability, and efficacy of~     IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study~     ZLB06_002CR (NCT01199705).~   "
122060|NCT01458158|"~     The purpose of this study is to determine whether matrix metalloproteinases are associated~     with atherosclerosis in the different stages of chronic kidney disease.~   "
122061|NCT01458145|"~     This is an efficacy study of an intensive home visitation intervention, Minding the Baby~     (MTB). This reflective parenting program (aimed at enhancing maternal reflective~     capacities), is focused on first-time young mothers and infants living in an urban~     community. The study, grounded in attachment and human ecology theories integrates advanced~     practice nursing and mental health care by pairing master's level nurse practitioners and~     social workers with at-risk young families. Aims of the study are: 1) to determine the~     efficacy of the MTB intervention in young mothers and infants with respect to a) maternal~     outcome variables including the quality of the mother-infant relationship, maternal~     reflective capacities, maternal mastery/self-efficacy, parental competence, and maternal~     health and life course outcomes (educational success, employment, delaying subsequent~     child-bearing); and b) infant outcome variables including early attachment, infant health,~     and developmental outcomes; 2) to monitor fidelity and dose of the program with young~     mothers; 3) to describe the evolution of reflective capacities in adolescent mothers~     (contrasting intervention group with control group) through descriptive qualitative analyses~     of transcribed Pregnancy Interviews and Parent Development Interviews at the last trimester~     of pregnancy and at 24 months; 4) to conduct cost-effectiveness analyses of the program. The~     longitudinal two-group study (subjects nested within randomly assigned groups), will include~     multi-method (self report, interview and direct observation and coding of behaviors)~     approaches with a cohort of first-time multi-ethnic mothers between the ages of 14-25 (and~     their infants). MTB home visits occur weekly for intervention families (n=69) beginning in~     mid pregnancy and continuing through the first year, and then bi-weekly through the second~     year. Mothers and infants (n=69) in the control group will receive standard prenatal,~     postpartum and pediatric primary care in one of two community health centers (as will the~     intervention group) and also receive monthly educational materials about child health and~     development mailed to their homes. Maternal and infant outcome variables will be followed~     over time (pregnancy, 4, 12, and 24 months) as well as compared between the 2 groups. Cost~     analyses and analysis of the dose and sample characteristics linked to efficacy, will allow~     us to plan for translation of the model into clinical care and community sustainability.~   "
122062|NCT01458132|"~     The World Health Organization has estimated that as many as 10% of the population worldwide~     may at some point experience at least one seizure. The percentage with active epilepsy is~     from 0.4% to 1%. From 40% to 65% of patients with HIV infection have been estimated to have~     some neurological involvement; the percentage reaches as high as 70% to 80% when post-mortem~     assessments are included. Estimates of the percentage of HIV-infected patients with seizure~     occurrence have varied widely, with one review finding a range from 2% to 20%. The highest~     percentage in this range was reported at a center that exclusively treated patients with~     neurological involvement, in India where HIV clade C subtype is predominant. Query of~     another neurology department's database determined that of the HIV-infected patients treated~     at the center, all of whom were referred for neurological symptoms, 6.1% experienced~     seizures. Underlying neurologic diseases in these patients included HIV-associated~     encephalopathy, progressive multifocal leukoencephalopathy, and toxoplasmosis. In a Spanish~     population, 3% of HIV-infected patients over a one-year study period were found to have~     new-onset seizures, which were attributed to drug toxicity in 47%, intracranial lesions in~     35%, and metabolic derangements in 12%.~      Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have~     produced recent evidence that some antiretroviral therapies may have neurotoxic effects,~     warranting further research. Individuals who are treated with highly active antiretroviral~     therapy are at risk for immune reconstitution inflammatory syndrome (IRIS), in which immune~     recovery triggers clinical deterioration as the newly invigorated immune system reacts to~     pathogens that either represent ongoing opportunistic infection or were previously~     successfully controlled. In a population initiating combination antiretroviral therapy~     between 1999 and 2007, 0.9% developed neurological manifestations of IRIS. Seizures may~     occur as part of a neurological IRIS syndrome, such as encephalitis and toxoplasmosis.~      Two randomized, Phase 2b dose-finding studies were conducted in HIV-1 infected adults to~     compare GSK2248761 100 mg and 200 mg given once daily as part of an antiretroviral treatment~     regimen. One of the studies (SGN113399) was in subjects with prior exposure to~     antiretroviral therapy where GSK2248761 100 mg and 200 mg once daily were compared to~     determine the best dose in this population. A contemporary control arm receiving etravirine~     200 mg twice daily was also included, and all arms included a twice-daily background therapy~     consisting of darunavir/ritonavir 600 mg/100 mg plus raltegravir 400 mg. The other study~     (SGN113404) was in treatment-naïve subjects, comparing GSK2248761 100 mg and 200 mg once~     daily to determine the best dose in this population. A contemporary control arm receiving~     efavirenz 600 mg once daily was also included, and all arms were given background therapy~     selected by investigators from either once-daily abacavir/lamivudine 600 mg/300 mg or~     tenofovir/emtricitabine 300 mg/200 mg. Of a planned total population in both studies of 300~     subjects, 35 were enrolled before the studies were terminated because of the occurrence of~     seizures in five subjects. All of the subjects who experienced seizures were enrolled into~     SGN113399, four randomized to receive 200 mg GSK2248761 and one randomized to receive 100 mg~     GSK2248761. There were no seizures in the subjects receiving GSK2248761 in study SGN113404.~     At the time of study termination, subjects had been enrolled and received GSK2248761 at 19~     sites in four countries: France, Romania, United States, and Germany. Although potential~     contributory conditions have been identified in some cases, definitive causative factors for~     the seizure occurrence have not been established.~      The purpose of this study is to follow subjects who previously received GSK2248761 while~     enrolled in the Phase 2b studies, which were halted due to unexpected seizures. The study~     will collect data on all subjects and will be used to monitor for additional seizures as~     well as collect additional clinical data on all subjects.~   "
122063|NCT01458119|"~     This is a long term, open label study of migalastat HCl (AT1001) in subjects with Fabry~     disease who completed treatment in a previous monotherapy trial with migalastat~     hydrochloride (HCl).~   "
122064|NCT01458106|"~     The primary objective of the study is to evaluate the safety of Recombinant Coagulation~     Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with~     hemophilia A. Secondary objectives of this study in this study population are as follows: to~     evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to~     evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc~     consumption for prevention and treatment of bleeding episodes.~   "
122065|NCT01458093|"~     In colorectal cancer screening era a huge burden of medical resources has been applied to~     surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a~     mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of~     surveillance are lacking.~      The aim of present study was to evaluate the percentage of subjects in which timing of~     surveillance colonoscopy in practice agrees with that recommended by guidelines and to~     identify factors associated to the appropriateness of surveillance.~   "
122066|NCT01458080|"~     Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current~     mainstay of treatment is combination therapy with pegylated interferon and ribavarin.~     Thrombocytopenia as a treatment related adverse event or a complication of chronic liver~     disease often necessitates dose reduction and discontinuation in these patients.~     Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor~     in development for the treatment thrombocytopenia associated with various conditions,~     including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III~     trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated~     early due to an imbalance of thromboembolic events (TEE) between the placebo and the~     eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE~     2) are being conducted in approximately 1500 patients to evaluate the efficacy of~     eltrombopag in enabling HCV patients to achieve sustained viral response. Due to the~     similarities between the patient groups in ELEVATE and ENABLE, there is a concern that~     invasive procedures may influence the risk of TEE in the ENABLE population. This~     observational, non-interventional, retrospective, multicentre, nested case-control study~     will collect data from chart abstraction and medical record review to augment data from the~     ENABLE case report forms particularly with regards to invasive procedures. The study~     population includes cases and controls drawn from the ~1500 participants of the ENABLE~     trials. All eligible cases of TEE will be included in the study as cases. All other patients~     who participated in the ENABLE trials and did not experience a TEE, will be eligible to be~     selected as controls. Case report forms will be developed to enable standardized data~     capture. The Sponsor has contracted with the Clinical Research Organization, Outcome~     Sciences Inc to manage the study. ENABLE investigators will work with Outcome staff to~     obtain relevant information from the treating physician (e.g. surgeon) and the facility~     where the invasive procedure was performed (pre-operative tests, peri-operative course,~     diagnostic testing for TEE). Single point abstraction will be performed to obtain data from~     the medical record and from any additional data resources obtained by the investigator~     (e.g., operative note, anesthesia record). Analyses will be conducted using logistic~     regression models to estimate the risks. The primary objective of the study is to evaluate~     if there is an increased risk for TEE among patients who had an invasive procedure while~     exposed to eltrombopag (during the ENABLE trials).~   "
122067|NCT01458067|"~     The study consists of a pre-screening period to determine if the subject's tumor has PTEN~     deficiencies. Subjects then continue into the screening phase for Part 1, 2, or 3, as~     appropriate. In Part 1, subjects will then receive a single dose of 25 mg. After analysis of~     24 hour pharmacokinetic (PK) samples, subjects may receive continuous dosing or receive a~     single modified dose. In Part 2, subjects will be enrolled and dose escalation will occur in~     a 3+3 design. Subjects will receive a single dose on Day 1, and then begin continuous daily~     dosing after collection of a 72-hour PK sample. Additional subjects may be enrolled at lower~     dose levels for assessment of pharmacodynamic response. In Part 3, up to two tumor-specific~     expansion cohorts will be enrolled and receive the MTD or BED as defined in Part 2. A~     minimum of 12 and a maximum of 20 evaluable subjects will be enrolled in each cohort.~     Interim monitoring for futility will be incorporated after response data from 12 subjects~     are available. In addition, up to 20 evaluable subjects will be enrolled into Part 3~     -Signal-finding Expansion Cohort at the MTD or BED as defined in Part 2. All subjects in all~     parts/cohorts will receive daily dosing until withdrawal or unacceptable toxicity. All~     subjects in all parts/cohorts will receive daily dosing until withdrawal or unacceptable~     toxicity.~   "
122068|NCT01458054|"~     This study is a Phase I open label drug interaction study to evaluate the effect of~     omeprazole and ritonavir on GSK2336805.~   "
122070|NCT01458028|"~     Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy~     subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels~     in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects~     will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4~     days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated~     over the 5 days of the study.~   "
122071|NCT01458015|"~     The purpose of this study is to elucidate whether the additional mechanism of analgesia,~     i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different~     pain signs and symptoms in comparison to oxycodone.~   "
122072|NCT01458002|"~     This study targets two major risk factors for cancer; is designed to treat the behaviors on~     a population basis, using proactive recruitment strategies; intervenes on multiple behaviors~     simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the~     most promising approaches to low cost population based interventions for health-related~     behavior change, namely the internet; and develops and tests a promising new approach to~     increasing the utilization and effectiveness of internet-based interventions, relational~     agents. The primary aims are: (1) To develop and assess the effectiveness of a tailored~     internet intervention on a national sample; (2) To develop and assess the effectiveness of~     the internet intervention enhanced by a relational agent; and (3) To determine if the~     intervention with the relational agent can outperform the regular tailored internet~     intervention.~   "
122073|NCT01457989|"~     The objective of this meta-analysis is to provide data on long-term safety and efficacy~     following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion~     for retigabine using pooled data from ongoing open-label extension (OLE) Studies~     VRX-RET-E22-303 and VRX-RET-E22-304.~   "
122074|NCT01457976|"~     The study concerns a survey of attitudes of the public on issues around personal~     responsibility for health and the use of financial incentives to promote health in the U.S.~     and Germany. All data are gathered anonymously through online platforms. Two separate~     professional panel providers are used for access to members of the public. All participants~     are people who have voluntarily joined a survey panel in the past through an informed~     consent process and currently serve as panel members.~   "
122075|NCT01457963|"~     The primary objective of this study was to estimate the prevalence of PE among consecutive~     ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent~     injection, regardless of whether PE was suspected clinically. The secondary objectives were~     to assess the association between PE and DVT, to identify risk factors for VTE, and to~     determine the outcome of VTE.~   "
122076|NCT01457950|"~     The purpose of this study is to determine if denosumab is effective in increasing bone~     mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.~   "
122077|NCT01457937|"~     The cohort of post-menopausal women represents a group of very-difficult-to-treat patients~     in whom a more powerful approach is required in order to improve the disappointing response~     rate. Thus the addition, in patients with previous failure to PEG/RBV treatment or in naïve~     patients, of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by~     the results of SPRINT_2 trial in whom Boceprevir addition determined a 30% improvement in~     SVR rate in difficult gt 1 patients of African descent versus standard PEG IFN/Ribavirin~     therapy or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment~     with Boc/P/R of previous failure of standard therapy.~      Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir~     to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in~     patients difficult to treat, such as HCV-positive women in post-menopausal women with~     genotype 1, not only those who have never been treated, but also in those who have not~     responded to previous treatment with peginterferon and ribavirin (Riba).~   "
122078|NCT01457924|"~     Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that~     specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which~     expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid~     immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that~     targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the~     relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to~     be both well tolerated and efficacious in several indications, including a small,~     placebo-controlled trial in RRMS using an intravenous (IV) formulation.~      This double-blind, placebo-controlled, parallel-group study will investigate the safety and~     efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS.~     The primary objective of the study is to investigate the efficacy as assessed by magnetic~     resonance imaging. Other objectives will include evaluation of tolerability/safety,~     dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well~     as other clinical endpoints.~   "
122079|NCT01457911|"~     Primary Objective:~        -  To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL~          M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control~          as reflected by HbA1c during a 20-week treatment period in patients with type 2~          diabetes mellitus (T2DM) inadequately controlled with metformin.~      Secondary Objectives:~        -  To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed~          dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in~          comparison with glimepiride (AMARYL) alone at week 20.~        -  To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of~          glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL)~          alone at week 20.~        -  To assess the safety and tolerability of fixed dose combination of glimepiride and~          metformin (AMARYL M 1/250mg).~   "
122080|NCT01457898|"~     Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac~     patients but more studies are necessary to clarify its respiratory and hemodynamic effects.~     Therefore, the investigators objective was to study its effects in the oxygenation index~     (PaO2/FiO2) and in hemodynamic variables in this group of patients.~   "
122126|NCT01457300|"~     The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District~     Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care~     Rehabilitation Programme in Short Term Beds in Nursing Homes.~   "
122081|NCT01457885|"~     Although transplant results for AML in complete remission (CR) at the time of transplant~     have improved, transplant results for non-remission AML have been quite poor. Most~     multi-center studies have focused on standard risk AML patients and not many studies have~     been done in this population of patients with non-remission AML. There are a large number of~     older patients with non-remission AML because the complete remission rate with induction~     chemotherapy decreases with age. Such older patients do not tolerate conventional full~     intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for~     non-remission AML is a great unmet need for current transplant practice.~      From the investigators earlier study, it is suggested that replacing Fludarabine of standard~     FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in~     the transplant conditioning regimen may potentiate the anti-tumor activity of the~     conditioning regimen without adding significant toxicity, a goal of new conditioning regimen~     development.~      The investigators expect to enroll a total of 75 patients from about fifteen sites. The~     investigators main objective is to confirm both the safety and efficacy as measured by~     one-year overall survival, of the CloBu4 combination as full intensity conditioning for~     non-remission acute myelogenous leukemia.~   "
122082|NCT01457872|"~     This study aims to study and implement active referral of heroin users from a syringe~     exchange programme to evidence-based treatment for heroin addiction. Patients are randomized~     to either a strength-based case management intervention or a control group, while both~     groups receive referral to medical investigation for inclusion in substitution treatment for~     heroin addiction. The hypothesis is that syringe exchange can be used for referral to~     effective treatment, and that a strength-based intervention can increase the number of~     patients who are successfully referred and enter treatment.~   "
122083|NCT01457859|"~     The purpose of this study is to assess whether triclosan-coated sutures reduces wound~     infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG~     patients.~   "
122084|NCT01457846|"~     The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547~     compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose~     tumours are found to have increased number of FGFR2 gene.~   "
122085|NCT01457833|"~     Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes~     in the same way following either implantation of endobronchial valves or intrabronchial~     valves.~   "
122086|NCT01457820|"~     Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has~     the potential to help improve oxygen supply to heart muscle. In this study the Investigators~     aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor~     on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed~     with heart disease, when exercising on a treadmill. The Investigators are also are trying to~     figure out the best dose of allopurinol to use and to see how quickly it begins working. To~     do this the investigators will recruit patients with angina, exercise them on a treadmill~     after giving different doses of allopurinol and see if there is an improvement in their time~     to bring on angina symptoms and signs. Patients recruited to this trial will receive three~     different treatment regimes over a six week period. Each treatment regime will last for one~     week with a one week rest period between each regime. This will involve up to eleven visits~     to Ninewells Medical School, Dundee for testing.~   "
122087|NCT01457807|"~     To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new,~     different extended release formulations of tablets of AZD3241 (300 mg), in relation to the~     100 mg extended release tablet used in a previous study and potential food interaction. The~     safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In~     addition to these a number of exploratory objectives will be investigated with blood~     sampling.~   "
122088|NCT01457794|"~     The aim of this randomized crossover study, is to investigate the effect of school meals~     based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep~     quality, physical activity and risk markers of cardiovascular disease (CVD), type II~     diabetes and osteoporosis in 8-11 year old Danish school children.~      The participating 3rd and 4th grades on 9 selected primary schools will be randomized to~     either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual~     school lunch for 3 mo and then crossover for additional 3 mo. All participants will be~     examined three times; at baseline, after 3 mo and after 6 mo.~   "
122089|NCT01457781|"~     This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine~     Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as~     Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).~   "
122090|NCT01457768|"~     This Registry is designed to obtain long term data on participants who have failed to~     achieve sustained virologic response (SVR) while receiving at least one Gilead oral~     antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.~   "
122091|NCT01457755|"~     This Registry is designed to provide long term clinical and virologic follow up in~     participants who have achieved sustained virologic response (SVR) while participating in a~     previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is~     observational and no treatment is provided for HCV.~   "
122092|NCT01457742|"~     The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio~     Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients~     with mild to moderate Osteoarthritis and to determine the duration of clinical benefit~     following discontinuation of treatment.~   "
122093|NCT01457729|"~     Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard~     bike ergometer which is additionally equipped with a system to gather training data and the~     ability to send daily training time to an internet server to which the physician has access.~     Training time of two groups is compared. Group one is not motivated while group two benefits~     from telephone feedback when training time declines. It is presumed that training time~     increases with better information and response to training behaviour.~   "
122094|NCT01457716|"~     The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and~     Formoterol after administration of 3 different product variants of Budesonide/Formoterol~     Easyhalers and Symbicort turbuhaler.~   "
122095|NCT01457703|"~     The purpose of this study is to determine why obese women have lower hormone levels and less~     fertility than women of normal body weight. The proposal will examine the reproductive~     system at the level of the brain and the ovary to define the changes that happen leading to~     lowered hormone production. Women will be studied throughout a menstrual cycle and given~     medications that will test how well their pituitary gland can make hormones that stimulate~     the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also~     be given a medication to abolish estrogen production in the body and their response to this~     medication will be assessed. Finally, the ovary's ability to produce progesterone after~     ovulation will be examined.~      --Hypotheses:~        1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing~          hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese~          compared to normal weight women)~        2. Obese women have abnormally increased sensitivity to estradiol negative feedback which~          will be reversed by an aromatase inhibitor. (comparative study of obese compared to~          normal weight women)~   "
122096|NCT01457690|"~     To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the~     classical lipid-soluble form in a population of patients with intestinal malabsorption~     (hypocholesterolemias family by retention of chylomicrons).~   "
122097|NCT01457677|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with~     major depressive disorder having inadequate response to ongoing antidepressant treatment.~     Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or~     matching placebo. The anticipated time on study treatment is 6 weeks.~   "
122098|NCT01457664|"~     This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in~     healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of~     RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.~   "
122099|NCT01457651|"~     The risk of respiratory failure after cardiac surgery is high, and it may result in many~     complications. The maneuver of alveolar recruitment may improve the oxygen transport in the~     human organism. The investigators compare three different types of alveolar recruitment in~     patient after cardiac surgery, to reveal which one is better.~   "
122100|NCT01457638|"~     The purpose of this study is to determine whether inferior turbinate surgery during~     rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.~   "
122101|NCT01457625|"~     Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation~     of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis~     patients; besides, it is associated with insulin resistance in general population. Hepatic~     fat accumulation enhanced fetuin A secretion in animal model.~      Objects This study is designed to investigate the association of fetuin A level, insulin~     resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the~     survival of dialysis patient with different hepatic fat content.~      Methods. This is a prospective observational study. Three hundred and fifty ESRD patients~     undergoing maintenance HD or PD will be recruited for this prospective investigation. All~     the participants will receive baseline abdominal ultrasound for estimation of hepatic fat~     content. Hepatic fat content will be estimated as minimal, mild, moderate or severe~     according to the Hepburn classification. Besides, all participants also check baseline~     fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C),~     nutritional parameter and other biochemical parameters. All participants will be followed~     for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV~     mortality.~      Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels~     which may lead to long-term survival benefits.~   "
122102|NCT01457612|"~     The primary study objective is to investigate the potential chronic beneficial effect of~     polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant~     individuals through their ability to modulate oxidative- and inflammatory-markers that lead~     to devastating disease, including, but not limited to, diabetes and cardiovascular disease.~   "
122103|NCT01457599|"~     The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic~     metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators~     want to investigate if the wire marking is a possibility to mark respectively to identify~     these lesions. Further the investigators want to evaluate how many patients with complete~     radiologic have complete histologic response in their specimen respectively in how many~     specimens in the definitive histology tumor cells are visible.~   "
122104|NCT01457586|"~     Observational Study of Hemoderivative Transfusion Imputable Complications in Initial~     Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical~     ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs~     up to the beginning of the second postoperative day.~      Blood transfusion might be only a marker of the patient severity.~   "
122105|NCT01457573|"~     A single center, pilot trial with combination therapy of tamsulosin and solifenacin in 20~     men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at~     baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient~     reported outcomes.~   "
122106|NCT01457560|"~     This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK)~     Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix~     hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of~     DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.~   "
122107|NCT01457547|"~     The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and~     HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.~   "
122172|NCT01456676|"~     The purpose of this study is to determine the feasibility of administering the combination~     of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid~     leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose~     level (RP2D) of LDE225 in combination with nilotinib.~   "
122173|NCT01456663|"~     This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate,~     severe hepatic impairment compared with healthy control subjects.~   "
122108|NCT01457534|"~     Background. Acute renal failure after liver transplantation (LT) requiring continuous renal~     replacement therapy (CRRT) adversely affects patient survival. However, there are few~     reports to assess the predictors for postoperative CRRT in liver transplant patients. The~     investigators undertook this study to identify perioperative factors that would predict~     patients at risk of CRRT.~      Patients and Methods. The investigators retrospectively reviewed the data of 148 liver~     transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei~     University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44~     (18 patients from living and 26 from deceased donors) and those without CRRT was 104.~     Univariate and stepwise logistic multivariate analyses were performed.~   "
122109|NCT01457521|"~     This trial will compare two oral analgesic regimens in women undergoing first trimester~     medical abortion with mifepristone and misoprostol. The primary study outcome is pain.~   "
122110|NCT01457508|"~     This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals'~     (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate~     administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at~     3, 5 and 11 (or 12) months of age.~   "
122111|NCT01457495|"~     This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly~     SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the~     separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines~     administered at 3 and 5 months of age.~   "
122112|NCT01457482|"~     Earlier research has shown that pregnant women with a pronounced fear of childbirth have a~     significantly increased risk for birth complications and subsequent psychological trauma. In~     Sweden and also internationally, women in fear of childbirth are treated in many differing~     ways. Evidence for best care for these women is lacking. The Art Therapy method is a~     creative, psycho-therapeutic form of treatment which has been used for several decades~     within psychiatry. It has recently been seen that the Art Therapy method has positive~     effects during treatment for crisis reactions.~      Recruitment has recently been initiated for a randomized controlled study of Art Therapy for~     the treatment of fear of childbirth.~      The hypothesis for the study is as follows:~      H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in~     fear of childbirth when compared to treatment by therapeutic conversations only.~      The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery~     Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in~     Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.~   "
122113|NCT01457469|"~     This randomized clinical trial studies enhanced quitline intervention in smoking cessation~     for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may~     help patients with early-stage cancer quit smoking~   "
122114|NCT01457456|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Morquio~     disease from plasma~   "
122115|NCT01457443|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe~     disease from plasma.~   "
122116|NCT01457430|"~     The investigators propose a study to evaluate the safety, local tolerability, convenience,~     and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary~     angioedema. The investigators believe that self administration with Icatibant for treatment~     of an acute attack of angioedema will not change the time to complete or near complete~     resolution of symptoms compared to treatment with Icatibant in a medical facility.~   "
122117|NCT01457417|"~     The purpose of this trial is to characterize the safety and toxicity of DKN-01 by~     determining a maximum-tolerated dose and associated dose limiting toxicity. To evaluate the~     pharmacodynamic response in patients with cancer. To characterize the pharmacokinetic~     parameters of DKN-01 in cancer patients who are intolerant to standard/approved therapies.~   "
122118|NCT01457404|"~     The purpose of this study is to assess the safety and practicality, feasibility and efficacy~     of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans~     population, as delivered by routine clinicians at the Veterans Affairs.~   "
122119|NCT01457391|"~     The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as~     delivered by routine addiction counselors in community treatment programs, and to compare~     CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on~     the primary outcomes.~   "
122120|NCT01457378|"~     The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy~     patients is to demonstrate the ability of composite score of frequency of gastrointestinal~     symptoms to discriminate healthy subjects and IBS patients. The properties of this~     questionnaire of composite score of gastrointestinal symptoms frequency will be compared to~     other validated questionnaires (severity of IBS symptoms and HRQoL).~   "
122121|NCT01457365|"~     Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a~     subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence~     of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in~     China. This study will research the serum 25OHD level to get the prevalence of vitamin D~     deficiency and insufficiency of urban and rural residents in Sichuan Province, China.~   "
122122|NCT01457352|"~     The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in~     the treatment of spasticity.~   "
122123|NCT01457339|"~     This is a multiple ascending dose study; the purpose of this study is to examine the safety,~     tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic~     Patients who are currently maintained on a stable dose of an antipsychotic medication.~   "
122124|NCT01457326|"~     The purpose of this prospective study is evaluate the effect of a standardized early weight~     bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes~     of lower extremity periarticular fractures. The investigators null hypothesis is that the~     early weight bearing protocol will have the same effect as a traditional 10-week non-weight~     bearing protocol on clinical outcomes.~   "
122125|NCT01457313|"~     postoperative pain and analgesic consumption between the first and the second surgery would~     be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).~   "
122127|NCT01457287|"~     This is a prospective, longitudinal, controlled study of cognitive function and fatigue in~     patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In~     addition to following each patient over time (i.e. acting as their own control), a separate~     control group will consist of patients with early stage CRC (Stage A or B) who have had~     surgical resection of their tumour, but who do not require adjuvant chemotherapy, or~     patients with stage C CRC who have declined chemotherapy.~      Also included is a smaller sub-study of patients with limited metastatic CRC who are treated~     with more toxic chemotherapy~      To compare changes in cognitive function, as compared to baseline assessment, of patients~     with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of~     cognitive function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.~   "
122128|NCT01457274|"~     In this trial, patients undergoing elective colonoscopy under sedation will be randomised to~     BIS-guided sedation targeting either light (bispectral index [BIS] 70-80) or deep~     (BIS<60) sedation. Sedation will be achieved with a standardised regimen of~     target-controlled infusion of propofol and fentanyl bolus. The primary end point will be the~     incidence of procedure recall in each group - this will be assessed at the conclusion of the~     procedure. The procedural conditions, cardio-respiratory complications and recovery~     including cognitive function will be assessed during and immediately after the procedure.~     The incidence of dreaming and patient satisfaction with anaesthesia care will be recorded~     immediately after the procedure. The study will be complete when the patient leaves the~     hospital on the day of the procedure.~   "
122129|NCT01457261|"~     Idiopathic pulmonary fibrosis is a relentlessly progressive disease that is responsible for~     the deaths of over 5000 people in the UK each year. At present, despite a dramatic increase~     in clinical trials in the last decade, there are no licensed treatments for IPF. The~     pathogenesis of the condition remains incompletely understood, nonetheless there is good~     evidence to suggests that the condition arises as the consequence of an aberrant wound~     healing response in genetically susceptible individuals. Basic science research into IPF has~     identified a wide range of potential treatment targets. However, in many cases developing~     compounds to act against these targets, because of their role in normal wound healing, is~     limited by the possibility of major systemic side effects.~      The lung is highly amenable to topical therapy in the form of inhaled drug preparations and~     this route is utilised in the treatment of the majority of respiratory disease. The inhaled~     route offers a number of important potential advantages for administration of therapy to~     patients with IPF. Firstly, by limiting systemic exposure to drugs, the inhaled route offers~     the potential for achieving higher lung doses of drugs that might otherwise cause systemic~     toxicity. Secondly, inhaled treatment may more effectively reach the areas of abnormality in~     IPF, namely the hyperplastic epithelium and the underlying fibroblastic foci. Thirdly, the~     inhaled route offers an alternative to parenteral administration of compounds that are~     poorly absorbed through the gastro-intestinal tract e.g. monoclonal antibodies. It should be~     noted however, that the fibrosis in IPF develops peripherally involving the alveolar~     interstitium and the terminal bronchioles. Furthermore, the disease causes architectural~     destruction and distortion of the lung that is liable to alter the normal laminar flow of~     air (and inhaled particles) through the bronchial tree. It is therefore, by no means certain~     that it is possible to deliver inhaled therapies directly to regions of fibrosis in IPF.~      The feasibility of delivering inhaled drugs in IPF has not been previously studied. This~     research by assessing the effect of particle size on inhaled particle deposition and by~     relating to this the pharmacokinetic profile of salbutamol aims to validate the potential of~     the inhaled route in IPF. This study is an important precursor to the development of~     specific topical therapies for patients with IPF.~   "
122130|NCT01457248|"~     The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental~     lung model, endotracheal tube with taper-shaped cuff has been shown to decrease~     microaspiration. This effect has never been demonstrated in patients. The investigators~     hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of~     postoperative pneumonia in patients after aortic surgery.~   "
122131|NCT01457235|"~     Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive~     function and coping skills. Several studies have recently demonstrated that CR improves~     cognitive and occupational function in patients with schizophrenia and with depression (e.g.~     Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive~     and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what~     impact this might have on these people's abilities in terms of work, coping strategies,~     quality of life, and everyday safety.~      The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive~     and socio-occupational function in patients with previous mania and depression who~     experience persistent cognitive difficulties. Such effects would suggest implementation of~     CR in future treatment of bipolar disorder in order to facilitate the patients' ability to~     cope with the responsibilities related to work and everyday life. The hypotheses of the~     present study are that CR (in comparison to standard treatment) will 1) improve verbal~     learning and recall; and 2) improve sustained attention, executive function and psychosocial~     function.~   "
122132|NCT01457222|"~     The purpose of this study is to determine whether mindfulness is useful as primary~     prevention for psychological health in highschool students, primarily related to stress, and~     whether mindfulness can improve cognitive function.~   "
122133|NCT01457209|"~     The central hypothesis is that acupuncture break the vicious circle of androgen excess and~     reverse insulin resistance and improve health related quality of life and affective symptoms~     in overweight and obese women with and without Polycystic Ovary Syndrome.~   "
122134|NCT01457196|"~     The primary objective of this specimen correlative study is two-fold: to provide a mechanism~     for the association of known molecular alterations with clinical outcomes, and to provide~     rapid genetic profiling of alterations with known clinical utility using tumor and germline~     specimens to support treatment decisions.~   "
122135|NCT01457183|"~     This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how~     well the water stream is contained by a new containment device.~   "
122136|NCT01457170|"~     The purpose of this study is to determine the effects of Apelin on the lung circulation. The~     investigators hypothesise that Apelin will relax the lung blood vessels and improve the~     pumping ability of the heart.~   "
122137|NCT01457144|"~     Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and~     Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or~     refuse receive conditioning regimen followed by autograft.~   "
122174|NCT01456650|"~     The objective of the study is to know if the R230C and C230C variants of the ATP-binding~     cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect~     compared to the wild type allele (R230R) in patients with type 2 diabetes.~   "
122235|NCT01455857|"~     Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is~     superior to placebo when added to current therapy in reducing HbA1c in patients with type 2~     diabetes.~   "
122138|NCT01457131|"~     Background:~      - A new cancer treatment involves collecting white blood cells from an individual, modifying~     them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning~     them to the body. The cells may then be able to seek out the cancer cells and destroy them.~     Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the~     cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them~     to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1~     protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that~     stimulates the immune system. This type of therapy is called gene transfer.~      Objectives:~      - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against~     metastatic cancer.~      Eligibility:~      - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and~     has not responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and imaging studies.~        -  Participants will have leukapheresis about a month before the treatment to collect~          white blood cells.~        -  They will have chemotherapy 5 days before the treatment to suppress the immune system,~          and prepare the body for the anti-ESO-1/IL-12 cells.~        -  The anti-ESO-1/IL-12 cells will be given as an infusion.~        -  Participants will be monitored in the hospital during their recovery from the~          treatment.~        -  Participants will have regular followup exams every 1 to 6 months. The exams will~          include blood tests, imaging studies, and other studies.~      Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of~     the study....~   "
122139|NCT01457118|"~     The study objective of this open label, multicenter study is to provide access to NKTR-102~     treatment to subjects previously enrolled in a NKTR-102 study who are without signs of~     disease progression since receiving NKTR-102.~      In addition the study will evaluate the safety of continued exposure to NKTR-102, observe~     disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy~     of NKTR-102 in subjects with advanced or metastatic solid tumors.~   "
122140|NCT01457105|"~     self-expandable metal stents for palliation of malignant biliary strictures~   "
122141|NCT01457092|"~     The purpose of the study was to analyze the resolution rate of benign biliary strictures due~     to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully~     covered self-expandable metal stents.~   "
122142|NCT01457079|"~     Radiation therapy has been, and is being used in treatment of patients with keloid.~     Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate~     of keloid.~      Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause~     secondary cancers. The investigators also do not have a good understanding as to how~     effective radiation therapy is in preventing recurrence of keloid.~      Purposes of this study are to determine the long term safety as well as efficacy of~     radiation therapy when used for treatment of keloid.~   "
122143|NCT01457066|"~     The goal of this proposal is to culturally adapt and tailor an existing, theory-based~     intervention, using state-of-the-art methods designed to maximize cultural sensitivity,~     feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized~     controlled trial (n=60 intervention; n=60 control).~   "
122144|NCT01457053|"~     The purpose of this research study is to compare the effects (good and bad) of~     ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy~     (furosemide, torsemide, bumetanide) on your heart function and blood flow.~   "
122145|NCT01457040|"~     Evolving paradigms in the treatment of adult ALL include the application of intense~     pediatric regimens to the treatment of adolescents and young adults (AYA) and the~     optimization of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the cure~     of patients. The Cancer and Leukemia Group B (CALGB) and the Children's Cancer Group (CCG)~     first asked whether AYA between the ages of 16 and 20 fared differently whether they were~     treated on pediatric protocols. The results of this study demonstrated that although the~     complete remission rates were identical for the AYAs treated on the CALGB and CCG trials,~     the AYAs had a 63% event-free survival (EFS) and 67% OS at 7 years on the CCG trials~     compared with 34% and 46%, respectively, on the CALGB trials.~      High relapse and transplantation-related-mortality still remains great challenge for HSCT of~     adult ALL, which both range between 25% and 30%. Recently, risk-adapted indication and~     optimization of conditioning regimen are highlighted, which aiming to reduce TRM and relapse~     rate, respectively.City of Hope National Medical Center studied the substitution of~     etoposide (VP-16) for CY in the treatment of ALL patients receiving HCT. The result~     suggested that etoposide and TBI are associated with a decreased relapse rate following~     transplantation for ALL, compared with those receiving CY and TBI. Japanese and Germany~     reports pronounced the advantage of VP-16 in intensified regimen for adult ALL. On the same~     time, the investigators previous researches have confirmed the effect and safety of~     FA-intensified conditioning regimen on relapse and refractary leukemia.~      Based on mentioned above, the investigators speculate that VP-16-intensified conditioning~     regimen could improve the outcome for adult ALL. The potential mechanism will be attributed~     to reduce MRD and promote GVL effect via providing enough time-window for~     immuno-reconstitution by high-dose preparative regimen.~   "
122146|NCT01457027|"~     A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V~     according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine~     strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine~     strains and to assess the cross-protection against 4 selected circulating heterogeneous~     A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.~   "
122147|NCT01457014|"~     The purpose of this study is to evaluate positive pressure in patients with chronic pain~     taking opioid medications who have sleep disordered breathing.~   "
122148|NCT01457001|"~     Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the~     efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death~     for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin~     per os versus no treatment.~   "
122149|NCT01456975|"~     The investigators expect that the using of prothesis with sinuses has more benefits for long~     term competence and condition of aortic valve than the using of straight prothesis.~   "
122175|NCT01456637|"~     The object of this study is to determine whether feedback added to a self-help protocol for~     insomnia enhances the treatment effect. In this study all participants receive an online~     self-help cognitive behavioral therapy (CBT) intervention consisting of information~     (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with~     insomnia will be invited via a popular scientific website to fill out online questionnaires.~     Half of the participants will received by e-mail from a therapist, the other half of the~     participants will do the intervention without feedback. Participants will be measured 4, 16,~     and 40 weeks after intervention with the same questionnaires.~   "
122176|NCT01456624|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and~     Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.~   "
122177|NCT01456611|"~     The objective of this study is to evaluate the clinical equivalence and safety of the Test~     formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to~     the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in~     patients with osteoarthritis of the knee.~      The efficacy of both the Test and Reference formulations will also be compared to the~     Placebo gel to determine Superiority.~   "
122150|NCT01456962|"~     Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in~     human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral~     therapy (ART), but increases CD4+ T cells in the cervix is variable and not fully~     understood. Although the amount of HIV in the vagina declines in parallel with those in the~     plasma when antiretroviral therapy for HIV is started, HIV is still detected frequently in~     cervical samples from women with undetectable plasma viral loads, suggesting that low level~     viral replication in the female vaginal tract could lead to both inflammation and incomplete~     increases in CD4+ T cells. Two classes of HIV medications, nonnucleoside analogue reverse~     transcriptase inhibitors and protease inhibitors are substantially lower in the female~     genital tract compared to plasma, whereas concentrations of another class, nucleos(t)ide~     analogue reverse transcriptase inhibitors are similar or higher to those found in plasma.~     Thus, many widely used first-line three drug HIV therapies only achieve high concentrations~     of only two medications in the female genital tract. Importantly, with the recent~     development of raltegravir (RAL), which achieves concentrations in the female genital tract~     higher than those in plasma, ART regimens that deliver high concentrations of 3~     antiretroviral drugs to the female genital tract are now available. The investigators~     hypothesize that cervical CD4+ T cell reconstitution is better and inflammatory markers are~     lower in HIV-infected women on a HIV-therapy including tenofovir (TDF) and emtricitabine~     (FTC) with RAL versus ritonavir (RIT)-boosted atazanavir (ATZ), and that this is due to~     therapeutic concentrations of 3 versus 2 antiretroviral drugs in the female genital tract.~   "
122151|NCT01456949|"~     The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm,~     controlled,unblinded clinical study designed to provide long-term safety and effectiveness~     of the Arctic Front® Cardiac CryoAblation System.~   "
122152|NCT01456936|"~     This study is being conducted to assess varenicline and bupropion as aids to smoking~     cessation treatment in subjects with and without an established diagnosis of major~     psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified~     adverse events (AEs) in both of these populations).~   "
122153|NCT01456923|"~     Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy~     combined with surgery in colorectal cancer (CRC) avoiding surgery complications.~   "
122154|NCT01456910|"~     Resistance exercise (RE) has been proposed as a possible strategy for prevention and~     rehabilitation of diseases. The increase in both muscle strength and the ability to perform~     tasks of day-to-day work environment and are well-characterized benefits of this type of~     training. The literature has been investigating the effectiveness of the RE for humans, yet~     few studies have been conducted with intellectual disabilities (ID). It is known that a~     sedentary lifestyle contributes to the development of cardiovascular disease, type 2~     diabetes, hypertension, arthritis, and stress, depression, difficulty in socializing, stigma~     and discrimination. In particular, the ID is less active and is more likely to develop~     secondary diseases.~   "
122155|NCT01456897|"~     To investigate the safety and efficacy of long-term administration of OPC-34712 in patients~     with schizophrenia.~   "
122156|NCT01456884|"~     The purpose of this within-subjects randomized controlled trial is to determine whether two~     music therapy interventions are efficacious in reducing pain symptoms, in order to improve~     the quality of care for children in pediatric hospice. The investigators hypothesize that~     both music therapy interventions, live guitar and vocal intervention and vibroacoustic~     intervention, will reduce behavioural pain scores and that behavioural pain scores will~     correlate with physiological outcome measures.~   "
122157|NCT01456871|"~     The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP~     joint ligamento-muscular reflexes and their role is.~   "
122158|NCT01456858|"~     A Phase III malaria prevention trial was conducted in two camps of Liberian refugees in~     Sierra Leone using Insecticide Treated Polyethylene Sheeting (ITPS) or untreated~     polyethylene sheeting (UPS) randomly deployed to defined sectors of each camp. The ITPS was~     impregnated with pyrethroid insecticide during manufacture. In Largo camp the ITPS or UPS~     was attached to inner walls and ceilings of shelters, while in Tobanda the ITPS or UPS was~     used to line the ceiling and roof only. Cohorts of children up to 3 years of age were~     cleared of malaria parasites and monitored for up to 8 months post construction for possible~     malaria re-infection. Installation teams and refugee groups were blinded as to whether the~     sheeting was insecticide treated or not.~   "
122159|NCT01456845|"~     The purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of~     rifampicin and other antituberculosis drugs and compare these drug levels in patients who~     develop drug induced hepatotoxicity versus those who do not .The study hypothesis is that~     the ATT drug induced hepatotoxicity is related to free drug levels of rifampicin and other~     antituberculosis drugs .~   "
122160|NCT01456832|"~     This study is designed to determine the causes of low sodium (salt) in the body fluids~     outside the cells for patients who have received a kidney transplant at the Mayo Clinic of~     Florida. The investigators will look at data collected on previous transplant patients at~     the Mayo Clinic to determine if the low sodium levels could be related to factors occurring~     in the course of surgery. The investigators hypothesize that the intravenous fluid used in~     the surgery, which is about half the concentration of normal saline, could contribute to the~     low sodium levels.~   "
122161|NCT01456819|"~     This is a randomized and single blinded study aimed to compare the efficacy between~     intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell~     implantation and intramuscular autologous bone marrow mononuclear cells implantation only in~     patients with chronic critical limb ischemia. Patients will be randomized into two groups of~     equal number; patients in one group will be implanted with mononuclear cells and mesenchymal~     stem cells, and the other implanted with mononuclear cells only in the area of affected~     limb.~   "
122190|NCT01456442|"~     The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is~     to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with~     a short protocol barostat versus conventional procedures (i.e. standard barostat protocol~     and high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the~     development of fecal incontinence and symptoms of obstructive defecation.~      In this study volunteers will be examined - after explanation, physical examination and~     verification of in- and exclusion criteria - by anorectal barostat with short and standard~     protocol as well as by proctoscopy and endoanal ultrasound.~   "
122162|NCT01456806|"~     Objective: To evaluate the effect of system interventions (data recording procedures and~     complete coverage of medications and supplies) with or without physician and/or patient~     education, upon the psychological, clinical, metabolic and therapeutic indicators and the~     costs of care of people with type 2 diabetes.~      Design: Randomized 2x2 design; sample size was determined considering the change in~     haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of~     significance, and 80% power using a paired t-test. Sample size was increased by 25% to~     account for non-independence and patient drop-out.~      Setting: Primary care level in the city of Corrientes, Argentina with involvement of all~     three Argentinean health subsectors (public health, social security and the private, prepaid~     system).~      Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with~     type 2 diabetes. Patients of the participating physicians (nine in each group), were~     randomly selected and assigned to one of four groups (117 patients each): control, provider~     education, patient education, and provider/patient education.~      Intervention: Structured group education programmes were delivered to provider and/or people~     with type 2 diabetes by trained professionals; identical system interventions were applied~     to all four groups.~      Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c~     levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5~     questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.~   "
122163|NCT01456793|"~     The purpose of this study is to evaluate the effectiveness of the Teen Options to Prevent~     Pregnancy (T.O.P.P.) program in increasing contraceptive use and reducing repeat pregnancies~     among pregnant and parenting adolescents in central Ohio.~   "
122164|NCT01456780|"~     This is a Phase IV, single site, randomized, double masked, parallel control clinical trial~     of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for~     treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy~     will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of~     meibomian gland dysfunction and validated ocular symptom assessment questionnaire.~   "
122165|NCT01456767|"~     The design of this study conforms to a randomized double-blind placebo-controlled cross-over~     design.~      The objective of the study is to assess the effect of three probiotics (Lactobacillus~     plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450)~     on intestinal epithelial permeability and the immune system, in at least 8 healthy subject.~      The effect of the three different probiotics and a placebo will be assessed on every subject~     in random sequence.~      Prior to the start of a 7-days supplementation period (one of the three probiotic~     supplements or placebo), blood samples will be obtained and small intestinal permeability~     will be assessed by measuring the urinary extraction ratios of ingested water-soluble,~     non-degradable test probes, with and without indomethacin challenge (to compromise the gut).~     After each supplementation period the gut will be stressed again by the indomethacin~     protocol, followed by measurement of small intestinal permeability, whereupon blood samples~     will be taken and duodenal tissue samples will be obtained by standard gastroduodenoscopy.~     Each supplementation period will start 1 month after finishing the pervious test episode, in~     randomized sequence.~      The primary objective of this study is to assess the effects of Lactobacillus plantarum~     WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on~     intestinal epithelial permeability. Secondary objectives are to assess the effects on immune~     modulation, gene expression of peripheral blood mononuclear cells, small intestine~     epithelial gene regulation and tight junction proteins modulation, infiltration of immune~     cells in intestinal mucosa and immune markers in blood plasma.~      The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum~     CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect~     the innate immune system and intestinal permeability in humans.~   "
122166|NCT01456754|"~     The purpose of this study is to determine the effect of feeding frequency on glucose and~     insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.~   "
122167|NCT01456741|"~     Endobronchial lung cancer tend to manifest in three different patterns. It can present as a~     bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from~     peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial~     brushing and bronchial washing is recognized as the gold standard to diagnose central~     airways lung neoplasms. Some authors suggested that the addition of endobronchial needle~     aspiration (EBNA) to these conventional diagnostic methods may increase the sensitivity of~     bronchoscopy in submucosal and peribronchial disease but few prospective trials have been~     performed and this procedure is still underutilized in many centers. Rapid on-site~     evaluation (ROSE) showed to improve yield of transbronchial needle aspiration (TBNA) of~     mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate~     specimens and costs. However, its utility during endobronchial needle aspiration has not~     been substantiated.~      This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA~     with that of the conventional technique and to investigate the diagnostic yield of~     endobronchial needle aspiration and its contribution to CDM in the evaluation of patients~     with endobronchial lesions.~   "
122168|NCT01456728|"~     The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and~     omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.~   "
122169|NCT01456715|"~     Two human papillomavirus vaccines are now commercially available.~      No clinical data exist regarding:~        -  The immunogenicity and safety of Gardasil and Twinrix when co-administered.~        -  The immunogenicity and safety of Cervarix when administered to subjects previously~          vaccinated with Gardasil.~      The main objective of the first phase of this clinical trial was:~      • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when~     co-administered or administered at one month interval according to a 0, 6 month schedule to~     9-10 year-old girls.~      The main objective of the seconde phase of this clinical trial is:~      • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when~     given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.~      Study Design & Duration:~      Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study~     with two treatment groups.~      Duration of the study:~      Participants will be followed for the duration of 10 years post-primary vaccination.~      Number of Centres:~      One Center.~   "
122170|NCT01456702|"~     It is difficulte to evaluate risk patients and to find the ideal intraoperative volume~     management. It seems to be that ill patients benefit of a goal directed volume management.~     The aim of this study is to implement the guidelines on perioperative cardiovascular~     evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed~     protocoll for volume management.~   "
122171|NCT01456689|"~     The primary purpose of this dose escalation study is to estimate the maximum tolerated dose~     (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when~     administered orally once daily to adult patients with Multiple Myeloma (MM).~   "
122191|NCT01456429|"~     This is a prospective non-randomized multicenter clinical trial performing endobronchial and~     esophageal ultrasound for mediastinal lymph node staging of operable and resectable~     cT1-T2-selectedT3 cN1 cM0 NSCLC.~   "
122178|NCT01456598|"~     -  It was confirmed that the laparoscopic surgery decreases the postoperative pain and~          reduces the recovery periods in the various surgical fields such as cholecystectomy and~          colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is~          applicable to malignant tumor according to the development of surgical techniques and~          medical instruments.~        -  In case of early stage of gastric cancer, as the diverse clinical evidences, the~          gastrectomy has been commonly applied, however, the opening surgery is still applied~          for advanced gastric cancer due to lack of clinical evidence.~        -  In Korea, approximately 38% of patients who undergo surgery for gastric cancer are~          diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer~          registration business in 2009). There are various clinical evidences to apply~          laparoscopic surgery to the patients, however, most of them are retrospective or cohort~          study results.~        -  For the clinical application of surgical treatment regarding locally advanced gastric~          cancer using laparoscopic surgical technique, it requires the confirmation of definite~          execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of~          surgery and oncological usefulness should be verified.~        -  In order for this, it is only possible to confirm through the comparison of short-term~          surgical results (complications, mortalities, operative time and duration of~          hospitalization etc) and long-term results (survival rates and recurrence rates etc)~          between laparoscopic surgery and opening surgery based on the multicenter large-sized~          randomized prospective study with current standard treatment.~   "
122179|NCT01456585|"~     This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant~     and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive~     standard surgery followed by chemoradiation for their disease, but one dose of gem/cp~     870,893 will be pre-op and 3 doses post-op.~   "
122180|NCT01456572|"~     The purpose of this study is to determine the reciprocal control between gastric functions~     and intestinal parameters in the development of satiation in obese people.~   "
122181|NCT01456559|"~     The purpose with the planned study is to study Pleth Variability Index (PVI) as a non~     invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects.~     Lower body negative pressure (LBNP), a well established technique is used to create defined~     levels of hypovolemia.~      Primary hypothesis: By applying a breathing resistance (positive end expiratory pressure~     PEEP) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter~     signal (PVI) is enhanced and enables PVI to detect and grade the level of mild hypovolemia.~      Secondary hypothesis: 1) When tidal volume is increased, the respiratory synchronous~     variation in the pulse oximeter signal (PVI) will also increase. 2) The earlobe is superior~     to the finger in detecting PVI 3) Hemoglobin (Hb), detected non invasively by pulse~     oximetry, is not affected by hypovolemia created by LBNP~   "
122182|NCT01456546|"~     The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the~     pharmacokinetics of proguanil and clopidogrel.~   "
122183|NCT01456533|"~     Background: Hypo- and hypernatremia are common in hospitalized patients. The differential~     diagnosis of dysnatremia is challenging.~      Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism~     in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger~     precursor peptide along with copeptin, which is a more stable peptide directly mirroring the~     production of ADH.~      Objective: To evaluate the additional value of copeptin to improve a currently used~     algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe~     hypernatremia.~      Design: Prospective observational study.~   "
122184|NCT01456520|"~     This study aims to determine whether the hydrocodone and acetaminophen exposures following~     oral dosing of Vycavert are comparable to those following oral dosing of Norco.~   "
122185|NCT01456507|"~     The purpose of this study is to estimate the effects of food and of sprinkling ALO-02~     pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol~     from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered~     naltrexone 4.8 mg.~   "
122186|NCT01456494|"~     The purpose of this study is to evaluate the feasibility of enrolling and randomizing~     patients into one of two educational interventions to teach appropriate respiratory inhaler~     technique and to collect preliminary estimates of the comparative effectiveness of two types~     of education.~      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then~     repeated cycles of learning and assessment until a skill, i.e. respiratory inhaler~     technique, is mastered. By contrast, Brief Intervention (BI) education only consists of~     providing the patient with verbal and written instruction on the skill, i.e., respiratory~     inhaler technique.~      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's~     ability to learn respiratory inhaler technique. The investigators will test this hypothesis~     separately for the MDI and Diskus® devices.~   "
122187|NCT01456481|"~     About 20% of adults faint recurrently. These patients are often highly symptomatic, have~     problems with employment and driving and have reduced quality of life. There are no~     therapies that have withstood the test of adequately designed and conducted randomized~     clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist~     that increases venous return to the heart and raises blood pressure. There is considerable~     lower level evidence that it might prevent vasovagal syncope.~      The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in~     patients with moderate to severe vasovagal syncope.~   "
122188|NCT01456468|"~     The purpose of this research study is to determine whether the combination of UDCA and ATRA~     taken for 3 months will improve laboratory tests of liver and bile duct inflammation in~     patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of~     these medications will improve the liver inflammatory tests in these patients, specifically~     a reduction in alkaline phosphatase (AP) by at least 30%.~   "
122189|NCT01456455|"~     Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving~     CNS.~      Exploration of additional prognostic factors for brain involvement from gastric cancer.~   "
122192|NCT01456416|"~     The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis~     population than in general population. These MS patients category response unfavorably to~     the Interferon. The investigators suggest that autoimmune co morbidity can serve as a~     biological marker predicting good response to GA.~   "
122193|NCT01456403|"~     Patients scheduled for carotid endarterectomy undergo preoperative imaging to assess~     vulnerable plaque. The imaging modalities include (in various combinations at different~     study sites) 3-dimensional ultrasound, PET/CT imaging with fluorodeoxyglucose, MRI (3T)with~     gadolinium, and contrast ultrasound for assessment of neovascularity of plaques. At surgery~     the carotid endarterectomy is carried out with en bloc removal of the specimen, which is~     scanned and stained and assembled into 3D histology.~   "
122194|NCT01456390|"~     Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular~     hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent~     stents in combination with one iStent supra stent and a postoperative prostaglandin.~   "
122195|NCT01456377|"~     The aim of this study is to evaluate the effectiveness of the use of systemic~     corticosteroids administered orally in narrow lumbar canal syndrome.~   "
122196|NCT01456364|"~     Clopidogrel low response is associated with a significantly higher risk for ischemic~     complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more~     potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic~     events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in~     terms of their antiplatelet efficacy exists. The aim of this study is to assess the~     antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed~     clopidogrel low responders undergoing percutaneous coronary intervention.~   "
122197|NCT01456351|"~     The study addresses the question if a therapy with bendamustine plus rituximab is comparable~     (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to~     event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.~   "
122198|NCT01456338|"~     The purpose of this phase of the study is to further assess the efficacy of cognitive~     behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine~     addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC)~     on our primary outcomes.~   "
122199|NCT01456325|"~     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in~     participants with incurable non-small cell lung cancer identified to be Met~     diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb)~     or placebo in combination with erlotinib. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
122200|NCT01456312|"~     Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion~     rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week~     follow up)~      Secondary objective :~        -  The changes of HBsAg titer~             -  The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL ⅲ. The rate~               of serum HBV DNA < 300 copies/mL~                  -  The rate of ALT normalization ⅴ. The rate of HBsAg loss ⅵ. The rate of serum~                    HBV DNA < 10,000 copies/mL~   "
122201|NCT01456299|"~     The purpose of this study was to determine the most suitable effect-site concentration of~     remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.~   "
122202|NCT01456286|"~     The purpose of this study is to determine whether sapropterin (an oral analogue of~     tetrahydrobiopterin) could have a role in the treatment of portal hypertension secondary to~     liver cirrhosis. Sapropterin or placebo will be given for two weeks in patients with liver~     cirrhosis and clinically significant portal hypertension. Systemic and hepatic hemodynamics~     studies will be performed at baseline and after the intervention to assess the effect of~     sapropterin.~   "
122203|NCT01456273|"~     This study aims to evaluate, in patients with functional dyspepsia, a model example of~     medical care based upon the biopsychosocial model (called: the therapeutic encounter)~     compared with standard medical care based upon the biomedical model (called: medical~     consultation).~   "
122204|NCT01456260|"~     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during~     long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with~     a history of gastric or duodenal ulcer who require long-term therapy of NSAID.~   "
122205|NCT01456247|"~     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during~     long-term concomitant low-dose aspirin therapy in patients with a history of gastric or~     duodenal ulcer who require long-term therapy of low-dose aspirin.~   "
122206|NCT01456234|"~     The main purpose of this study is to see if patients with the flu would receive oseltamivir~     treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and~     to see if there is any difference in the effect of treatment on flu symptoms and overall~     health. Another reason for doing the study is to see how accurately pharmacists can diagnose~     the flu as compared to physicians. Viruses that are exposed to antiviral medications (like~     oseltamivir) sometimes develop a resistance to the medication. This means that the~     medication is no longer as effective in treating the symptoms caused by the virus. The~     development of viral resistance to oseltamivir will also be followed in this study.~   "
122207|NCT01456221|"~     The purpose of this study is to evaluate if a supplement containing omega-3 long chain~     polyunsaturated fatty acids for three months reduce obesity and insulin resistance to obese~     adolescents if administered together with a hypocaloric diet.~   "
122208|NCT01456208|"~     Thank you for your interest in the investigators Genetics and Blood Pressure Research Study.~     The National Institutes of Health are sponsoring us to investigate why patients develop high~     blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are~     two parts of the investigators research program. The first part is a screening visit. At~     this visit you will be given a brief physical exam and will be asked questions concerning~     your medical history. During the same visit you will have your blood drawn for routine~     screening and to prepare DNA for genetic testing. You will also be asked to collect a urine~     sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, the investigators will perform physiological~     tests after you are placed on a low salt diet and again after you are placed on a high salt~     diet. If you are on blood pressure medication, it may be necessary to discontinue taking~     your present medication for up to three months before beginning the study. Patients~     discontinuing their current blood pressure medication may be placed on a different blood~     pressure medication during this washout period if necessary to maintain blood pressure at~     pre-study levels. The investigators will take you off all medications at about two weeks~     prior to your scheduled in-patient study (overnight visits).~      Once your blood pressure medications are discontinued, you will be closely monitored to make~     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,~     the investigators will provide one for you to use during the study so that you can keep a~     daily record of your blood pressure readings. The investigators will ask you to call us~     every three days to report your blood pressure readings. Less than 20% of patients have any~     significant increase in their blood pressure during this short time off of therapy. After~     you have stopped taking your medication, dieticians at the hospital will make you low salt~     meals to eat at home for seven days. On the seventh day of the low salt diet, you will be~     asked to begin a 24-hour urine collection that you will bring with you when you are admitted~     to the hospital that evening. That morning, you will be required to come to the Clinical~     Research Center for a one-hour test to check if your body is in the correct salt balance.~     You will return that evening to the inpatient Clinical Research Center where you will be~     admitted for your study that will occur the next morning. On the morning of your low salt~     study, you will have naturally occurring hormones administered and blood samples drawn from~     an intravenous needle. The investigators will also take ultrasound pictures of your heart to~     see how salt and hormones affect the way the heart functions. These tests will last~     approximately five hours and you will be discharged around 2:00 PM. For the next five days,~     you will be placed on a high salt diet. During these five days, you will eat all your own~     food, but the investigators will give you some supplements to eat with your meals. After~     five days on your high salt diet, on the morning of your second admission to the hospital,~     you will be asked to begin a final 24-hour urine collection. That morning, you will again be~     required to come to the Clinical Research Center for a one-hour test to check if your body~     is in the correct salt balance. You will return that evening to the inpatient Clinical~     Research Center where you will be admitted for your final study that will occur the next~     morning. The same study that was done for the low salt study will be repeated for the high~     salt study. You will be discharged around 2:00 p.m. This study will determine if you are~     salt-sensitive. In addition, the investigators hope to learn more about the hormones that~     regulate your blood pressure and the genes responsible for regulating those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators will provide clinically~     relevant information to you and your physician.~   "
122209|NCT01456195|"~     The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam),~     once daily (QD), in participants with type 2 diabetes mellitus (T2DM).~   "
122210|NCT01456182|"~     This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels~     in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The~     trial will also determine the impact of dose on quality of life indices and on biological~     and immune responses, and will assess if there is a maximum tolerated dose and/or~     dose-limiting toxicity in this study population.~   "
122211|NCT01456169|"~     The purpose of this study is to evaluate the efficacy and safety of the fixed dose~     combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily,~     in participants with grades 2 or 3 essential hypertension who do not reach target blood~     pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.~   "
122214|NCT01456130|"~     The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on~     to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2~     diabetic patients with inadequate blood glucose control despite treatment with a~     rapid-acting insulin secretagogue as well as diet and exercise therapies.~   "
122215|NCT01456117|"~     The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on~     brain hemodynamics in healthy elderly participants.~   "
122216|NCT01456104|"~     This study is being done to see if the investigators can help the immune system to work~     against melanoma.~      A dendritic cell is another type of white blood cell. It has most, if not all, of the~     proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do~     not normally have the cancer proteins on their surface. The challenge then is to combine the~     antigens with dendritic cells to make a vaccine. The investigators think that the body's T~     cells might then react against the tumor and help destroy it.~      This study will see if altered dendritic cells will make T cells work against tumor cells.~     The dendritic cells will be made in a lab and will carry the antigens. These cells then will~     be injected under the skin.~      In this study, the investigators are trying to help the body make a stronger immune response~     against the cancer. The patient will get the same kind of dendritic cell vaccine used in the~     earlier study, but with one major difference. The dendritic cells will contain messenger-RNA~     (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a~     laboratory method called electroporation. The mRNA is never given to the patient directly.~     This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses.~     The dendritic cell can then put this tumor antigen on its surface so that the body could~     make a stronger immune response against the tumor.~   "
122217|NCT01456091|"~     The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in~     increasing the use of long-term contraceptives, in improving adherence to contraceptives and~     in preventing rapid repeat pregnancies among parenting adolescents.~   "
122218|NCT01456078|"~     By improved kidney dosimetry including biological effective dose and taking into account~     potential risk factors (especially for kidney toxicity), it might be possible to give an~     optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic~     neuroendocrine tumor.~   "
122219|NCT01456065|"~     The purpose of this study is to investigate the safety of the active immune therapy based on~     the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and~     Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced~     ovarian cancer, enrolled into the study within twelve weeks after completing primary~     therapy.~   "
122220|NCT01456052|"~     This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety~     and preliminary effectiveness of two blinded dose levels of LX1606 in subjects with acute,~     mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.~   "
122221|NCT01456039|"~     The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics~     of Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma~   "
122222|NCT01456026|"~     Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on~     vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular~     function remained unknown. Therefore, the aim of our study is to investigate the effects of~     heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type~     2 diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.~   "
122223|NCT01456013|"~     Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems~     undergo procedures that use iodinated contrast media, such as cardiac catheterizations.~     RenalGuard Therapy was developed to enable the patient to clear the contrast out of their~     kidney before it can do significant damage. This study aims to enroll patients with~     increased risk of developing CIN who are scheduled for a cardiovascular catheterization.~     Patients will be randomized to either RenalGuard therapy or standard therapy.~   "
122224|NCT01456000|"~     The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus~     Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial~     fibrillation by creating electrical isolation of the pulmonary veins.~   "
122225|NCT01455987|"~     Osteochondritis dissecans is a relatively common...~   "
122226|NCT01455974|"~     Unfavorably high sodium intakes remain prevalent around the world. A negative sodium~     gradient in hemodialysis treatment results in absolute sodium removal via diffusive~     transport of sodium from the blood to the dialysate, and it may be a potentially useful tool~     to improve sodium loading due to excess dietary sodium intake.~      The purpose of this study is to determine whether a in small negative sodium gradient could~     improve blood pressure level, arterial stiffness and left ventricular hypertrophy in~     hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight~     assessed by bioimpedance spectroscopy.~   "
122227|NCT01455961|"~     The aim of this study is to describe the treatment pattern and patient characteristics in~     real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel~     IR in Sweden.~   "
122228|NCT01455948|"~     The economic, patient related outcome, and effectiveness of balloon sinuplasty in the~     treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare~     environment is not known at this time. This study will evaluate the impact of balloon~     sinuplasty and traditional FESS treatment on CRS patients.~   "
122229|NCT01455935|"~     The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion~     studies as an indicator to treat stroke patients with unknown time of onset.~   "
122230|NCT01455922|"~     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to~     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.~   "
122231|NCT01455909|"~     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin~     monotherapy in patients with type 2 diabetes.~   "
122232|NCT01455896|"~     Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated~     with ITCA 650.~   "
122233|NCT01455883|"~     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to~     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.~   "
122237|NCT01455831|"~     The human body has a natural stress response to surgery, including the formation of blood~     clots. This response to surgery has been shown to increase metastases (the spread of cancer~     cells to other organs in the body). These metastases cannot be seen at the time of surgery~     but when they grow into new tumors, the cancer has recurred (come back). A blood thinner~     called low molecular weight heparin (LMWH) can suppress the development of metastases~     after surgery in animal experiments. The investigators want to see if giving patients with~     colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the~     chance of their cancer spreading to other organs (metastases) and coming back (recurrence).~      The investigators need 1075 patients to answer our scientific question. Patients who give~     informed consent will be randomly put into one of two groups, the experimental group and the~     control group. The patients in the control group will be treated with LMWH starting a few~     hours after surgery and every day until they leave the hospital. This is how most patients~     are treated after colon cancer surgery (standard care). The patients in the experimental~     group will be treated with LMWH for a longer period of time, starting on the day they agree~     to have surgery and continuing for two months after surgery. All the patients will be~     followed for at least three years after surgery to find out if their cancer has recurred~     (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence~     in patients with colorectal cancer, it would improve the health and quality of life for~     these patients.~   "
122238|NCT01455818|"~     Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological~     test called computed tomography (CT scan). As technology advances, the CT scans are able to~     detect smaller and smaller blood clots. Over time, the frequency of blood clots in the~     pulmonary arteries has increased significantly (CT scan are now detecting very small blood~     clots that the investigators could not see before). As a result, more and more people are on~     blood thinners to treat these small blood clots but their true clinical significance is~     unknown.~      The management of blood thinners is costly and also utilizes scarce healthcare resources.~     These blood thinners need to be monitored with frequent blood work. Furthermore, every year,~     approximately 3 percent of patients on blood thinners will have a major bleeding event~     requiring medical attention.~      The investigators don't think that treating these small blood clots in the pulmonary~     arteries detected on CT scan is worth the risk of bleeding from the blood thinners.~      The main goal of this study is to find out if it is safe to not treat very small blood clots~     in the pulmonary arteries.~      The investigators plan to follow 300 patients with small blood clots in their lungs for 90~     days. These patients will not be treated with blood thinners but will be followed closely~     with other non-invasive tests to avoid progression or recurrence of blood clots.~   "
122239|NCT01455805|"~     Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the~     lower part of the back. This causes discomfort in the legs when standing or walking because~     of pressure on the spinal nerves.There are several treatment options for LSS including~     physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy,~     Discectomy and more recently devices for interspinous distraction such as the XSTOP® and~     from May 2011 Minuteman™.~      Surgical decompression for LSS involves the removal of excess bone, ligament, and~     soft-tissue allowing more room for the nerves. The operation is usually preformed under~     general anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the~     Minuteman™ implant is preformed as a day case under local or general anaesthetic and~     involves implanting the device into the space between two back bones to relieve pressure on~     the nerves and, therefore, pain in the legs.~      This is a multi centred (four sites) randomised controlled trial with a total sample of 50~     participants after obtaining their informed consent. Participants will attend the pain~     clinic at the Hospitals for a baseline visit where they will be randomised with a ratio of~     1:1 to receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard~     surgical decompression for the treatment of lumbar spinal stenosis (LSS). Following~     randomisation arrangements will be made for the participant to receive the randomised~     treatment. If allocated to Minuteman™ Implant, the treatment will be conducted by the Pain~     Specialist identified at the site. If allocated to surgical decompression, the treatment~     will be conducted by the neuro/spinal-surgeon identified at the site. Participates will be~     followed up regularly for 60 months post implant to assess clinical efficacy, safety,~     participants function and quality of life of each treatment.~   "
122240|NCT01455792|"~     Background: Prostate biopsies are usually performed due to accidentally discovered elevated~     prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal~     ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise~     documentation concerning the localization of the biopsies are lacking. Therefore, the same~     locations might be subject to multiple negative biopsies. There is a growing confidence that~     magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade~     tumours, and studies have shown value in performing MRI before biopsies. Because image~     documentation is lacking, it is not possible to know which region actually being biopsied~     with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a~     new promising method that will ascertain all regions of the prostate gland to be biopsied,~     and it is possible to perform accurate targeted biopsies when combined with MRI.~      Aims of the study~      Compare the biopsy results in the two groups:~        1. To evaluate the overall rate of positive biopsies.~        2. To evaluate the rate of re-biopsies.~        3. To evaluate the detection rate of Gleason grade 4 and 5 tumours.~        4. To evaluate the rate of positive targeted biopsies.~        5. To evaluate the rate of positive random biopsies~        6. To compare targeted and random biopsies between groups.~        7. To compare patient tolerance, time consumption and cost of the two methods.~        8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted~          biopsies.~      Material and methods: A prospective randomized study including 300 consecutive patients~     referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies~     and image fusion guided biopsy.~      All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy~     will be obtained in case of positive MRI of ultrasound.~   "
122241|NCT01455779|"~     The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in~     women most likely to be treated in an office setting for the condition of stress urinary~     incontinence, secondary to urethral hypermobility.~   "
122242|NCT01455766|"~     The hypothesis of this observational single-center clinical study was to explore the~     volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic~     intervention. The investigators monitored the changes in the volumes of blood in the central~     vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e.~     extravascular lung water).~   "
122243|NCT01455753|"~     The aim of this project is to investigate whether the proximity of employees to flu-shot~     clinics will increase the uptake rates of employees participating in these clinics. The~     investigators hypothesize that ease of access is an important factor in whether or not~     employees receive an influenza vaccination.~   "
122244|NCT01455740|"~     The goal is to improve HIV patients' adherence to medication regimens. The investigators are~     planning an intervention in which the patient is given financial incentives to take clinic~     attendance seriously, and then given the option to make these incentives contingent on~     taking medications as prescribed—that is, to require better behavior from themselves to earn~     the same reward. Past studies have shown that conditional payments improve adherence to HIV~     treatment, but only while payments are being made. The investigators expect that patients~     will be willing to give up some payments to commit themselves to better adherence. The~     investigators also hope to see some patients maintaining good adherence after financial~     incentives are removed, among those who are given the opportunity to choose this commitment.~   "
122245|NCT01455727|"~     This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients.~     To provide appropriate diabetes education administration, identify and resolve drug-related~     problems, assess the appropriateness of their medications, establish the mechanism of~     medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State~     Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's~     intervention will be assessed by lab data and some questionnaires.~   "
122246|NCT01455714|"~     Finding early predictors of myocardial in patients with hypertension~        1. Scientific objective The study objective is to clarify the grounds of heart exertional~          dyspnoea stenocardial pain in patients with well-controlled stage I or II hypertension~          according to ESH (European Society of Hypertension), without changes in epicardial~          coronary arteries in coronary angiography and normal resting echocardiography result,~          and to assess of potential early markers of heart hypertrophy and failure in patients~          with hypertension.~           Characteristics of the final result The study is to allow for identification of~          patients with hypertension, in whom an early introduction of pharmacological treatment~          of heart failure should be considered. Evaluation in the detection of asymptomatic~          myocardial dysfunction will include potential heart failure markers such as:~          cardiotrophin 1, cystatin C, serum syndecan-4, collagen III N-terminal propetide~          [PIIINP], MMP-2, MMP-7, MMP-8, MMP-9 and NT-proBNP, modern echocardiography methods and~          magnetic resonance imaging in order to increase the effectiveness of prevention,~          diagnosis and treatment optimalization.~        2. Project significance Prognosis in heart failure is very serious. It is similar or worse~          than in advanced cancer. These data indicate an extreme importance of the optimal early~          causal treatment of hypertension and symptomatic treatment of heart failure early stage~          in order to prevent the development advanced form of the disease, which has bad~          prognosis. In clinical practice, patients with well-controlled hypertension often~          report exercise limitation, exertional dyspnea and/or stenocardial pain which is not~          reflected in a standard resting echocardiography (normal result), without coronary~          artery disease data in electrocardiographic stress test and without change in~          epicardial coronary vessels in coronary angiography. The study is designed to establish~          the panel of diagnostic tests in patients with hypertension and exertional dyspnoea~          only, which will allow for early detection of abnormalities (before symptoms occur) and~          the start of the optimal treatment for these patients. Unfortunately, still too small~          percentage of patients receives full pharmacotherapy, hence the authors of the latest~          guidelines of procedure in heart failure and hypertension put great emphasis on this~          aspect. Optimal management may prevent the progression of these patients in stage C~          heart failure, and thus bring tangible benefits not only the patients themselves but~          also, by reducing the number of costly hospitalizations, significantly reduce health~          care costs. The number of hospitalizations for heart failure in Poland is estimated at~          100 000 per year, and hospitalization costs exceed 70% of the total costs associated~          with the treatment of heart failure. The issue of exertional dyspnoea and overt heart~          failure in patients with hypertension and normal results of resting echocardiography is~          a new problem, both in Poland and in the world.~      So far, there are no treatment recommendations for this group of patients. Material and~     study plan 120 persons (age 40-60 years old) will be included in the study, patients with~     stage I or II primary hypertension according to the European Society of Hypertension: Group~     A- 40 patients without symptoms of heart failure Group B- 40 patients with exertional~     dyspnoea Group C - 40 patients with overt heart failure~      In group B (patients with exertional dyspnea/stenocardia) we will include only patients who~     have undergone contrast coronary angiography without any identified changes in the~     epicardial coronary arteries, which will facilitate answering the presented purpose of~     research. Patients in groups A and B with normal resting echocardiography and treated with a~     maximum of 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base),~     according to the following regimen:~      ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance~     with the standards for heart failure. Each patient will be informed about the objectives of~     the study and give written consent to participate.~      After signing informed consent patients will have performed the following tests:~        -  Interview and documentation analysis,~        -  Physical examination,~        -  Electrocardiogram,~        -  24-hour blood pressure monitoring (ABPM),~        -  24-hour EKG recording,~        -  Echocardiography at rest and during submaxinal exercise on a bicycle ergometer,~        -  Flow-mediated dilatation (FMD),~        -  Cardiac magnetic resonance imaging,~        -  Standard labolatory parameters,~        -  Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8,~          MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP~          Each patient will be informed about the objectives of the study and give written~          consent to participate.~   "
122247|NCT01455701|"~     This is a multi-center, open label single arm study to investigate the pharmacokinetics and~     safety of tocilizumab (TCZ) (RoActemra/Actemra) in participants less than 2 years old with~     active systemic juvenile idiopathic arthritis (sJIA). Participants will receive tocilizumab~     infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main~     evaluation period). Participants will have the option to continue TCZ treatment until~     participant reaches 2 years of age or up to one year from baseline, whichever is longer. An~     optional extension period will follow the main evaluation period.~   "
122248|NCT01455688|"~     The aim of the study is to verify the effect of HAART in critically ill HIV infected~     patients. The current practice is to begin antiviral therapy after ICU discharge, when the~     condition of the patient is more stable. The investigators hypothesis is that the~     investigators can improve outcome of these patients with earlier antiviral therapy in the~     ICU. The investigators just have retrospective studies in this scenario. After admission to~     ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission)~     or conventional therapy (initiation of HAART after ICU discharge). The following data will~     be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic~     infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be~     followed to determine ICU mortality, hospital mortality and 6-month mortality.~   "
122249|NCT01455675|"~     The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa~     after successfully treated acute or intermittent infection.~   "
122250|NCT01455662|"~     There is a correlation between hospital mortality and changes in markers of tissue~     perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.~   "
122251|NCT01455649|"~     The purpose of this study is to demonstrate the efficacy and safety in the use of~     everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.~   "
122252|NCT01455636|"~     Low birth weight (LBW) infants are particularly vulnerable to frequent infections and~     consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of~     complementary foods and ultimately micronutrient deficiencies that result in post-natal~     linear growth faltering. The objective of this study is to facilitate improved feeding~     practices through the early reduction of infections using the innovative tools of~     water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP)~     (beginning at 6 months of age). A community-based cluster randomized controlled trial will~     be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be~     recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12~     months, half of the children in each group will be randomized to receive I-MNP. All groups~     will receive nutrition and hygiene education from birth to 12 months. Recumbent length is~     the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary~     outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is~     the opportunity to translate the results directly and quickly into child health programs in~     Bangladesh.~   "
122253|NCT01455623|"~     It is necessary for outcome measures to accurately reflect the state of health of a person~     in order for clinical trials to show benefit. The most commonly used outcome measure for~     Charcot Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points~     designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are~     arbitrary. This study is looking to base mild, moderate, and severe on what both people~     affected with CMT and those who provide for people with CMT consider appropriate.~   "
122254|NCT01455610|"~     The purpose of this multicenter and double-blind clinical trial is to prospectively assess~     the sensitivity, specificity, negative predictive value, positive predictive value, and~     accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its~     various post processing techniques, taking operational and pathological records as the gold~     standard.~   "
122255|NCT01455597|"~     This is an open-label extension study evaluating the long-term safety and efficacy of WC3011~     in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.~   "
122256|NCT01455584|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     HM781-36B continuously.~   "
122257|NCT01455571|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) of~     HM781-36B.~   "
122258|NCT01455558|"~     This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR~     (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple~     doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.~   "
122259|NCT01455545|"~     This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and~     prescription count, influences level of asthma control in a sample of patients with severe~     and moderate-mild asthma.~   "
122260|NCT01455532|"~     Primary Objective:~        -  To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent~          and in combination with chemotherapeutic regimens in patients with advanced solid~          tumors that are refractory to standard therapy.~      Secondary Objectives:~        -  To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid~          Tumors [RECIST]) Version 1.1 in patients with measurable disease.~        -  To characterize iniparib (and its metabolites, if possible) pharmacokinetics.~      Based on data generated by Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell~     lines. Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
122261|NCT01455519|"~     You are asked to take part in this study because you have chronic, non-radicular low back~     pain. This study is done to investigate the pain relieving effects of the study drug Exalgo~     (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The~     purpose of this research is to look at how the study drug can be used to benefit people who~     experience this type of pain. This is a phase IV study done to study the safety and~     effectiveness of the drug. At this point the drug has been approved by the Food and Drug~     Administration and has been studied in more than 2,000 pain patients in clinical trials,~     including individuals with low back pain. About 36 subjects will take part in this study.~   "
122262|NCT01455506|"~     This is a single institution study of combining decitabine with fludarabine and busulfan in~     the setting of allogeneic stem cell transplantation. A study population of 20 subjects will~     be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center.~     Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation~     according to the eligibility criteria will be consented and enrolled. Subjects will receive~     treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to~     allogeneic stem cell transplantation. Subjects will be followed until 1 year post~     transplantation to assess stability of engraftment, toxicity, progression free survival, and~     disease response~   "
122263|NCT01455493|"~     This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of~     GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety,~     tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.~   "
122264|NCT01455480|"~     The objective of this Trial is to evaluate the performance of RPh201 as a treatment for the~     healing of partial thickness burns. It is further postulated that deep second degree lesions~     will benefit from the RPh201 treatment promoting granulation and epithelialization as well~     as wound closure.~   "
122265|NCT01455467|"~     Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in~     conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out~     of one anti-glaucoma medication prior to stent implantation.~   "
122266|NCT01455454|"~     Coagulopathy with transfusion requirements is frequent during cardiac surgery with~     cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole~     blood point of care test used to assess the patient's coagulation status.~      The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence~     of very high heparin concentrations as seen during cardiopulmonary bypass.~   "
122267|NCT01455441|"~     The objective of this study is to investigate the effects of physical training in patients~     with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®)~     in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.~      Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients~     when training is combined with liraglutide (Victoza®) treatment.~   "
122268|NCT01455428|"~     To prove pregabalin is effective in relieving pain compared with placebo in subjects with~     postherpetic neuralgia (PHN).~   "
122269|NCT01455415|"~     This study is to test the effectiveness of pregabalin in treating nerve pain caused by~     diabetes. The suitable subjects will be patients who also use an non-steroid~     anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.~   "
122270|NCT01455402|"~     The primary objective of this observational study is to determine the incidence of medically~     attended (inpatient or outpatient) acute respiratory illnesses or events leading to~     worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary~     disease [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie,~     those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.~   "
122271|NCT01455389|"~     The goal of phase 1 of this clinical research study is to find the highest dose of~     DOTAP:Chol-fus1 that can be safely given in combination with Tarceva (erlotinib~     hydrochloride) to patients with NSCLC.~      The goal of phase 2 of this clinical research study is to learn if the combination of~     DOTAP:Chol-fus1 and erlotinib hydrochloride can help to control NSCLC.~      The safety of this drug combination will also be studied in both phases.~      DOTAP:Chol-fus1 is a drug that helps transfer a gene called fus1 into cancer cells.~     Researchers think that cells without this gene may be involved in the development of lung~     cancer tumors. They want to find out if replacing the gene in these cells may keep the~     tissue from forming cancer cells.~      Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor~     growth and survival. This may stop tumors from growing.~   "
122272|NCT01455376|"~     Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI~     disability could stem from cognitive, physical, psychological and social dysfunction which~     resulted in significant disability and unemployment. Long-term behavioral impairments which~     affected the individual's occupation, lifestyle, and family frequently occurred in~     individuals with mild to moderate brain injuries who physically fully recovered. In-vitro~     and in-vivo studies showed a better recovery of cognitive function after administration of~     exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the~     effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on~     cognitive function assessed by Mini Mental State Examination(MMSE)scale.~   "
122273|NCT01455363|"~     The investigators aim to test the hypothesis and to proof thank to laser speckle contrast~     imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in~     this case, through a basal cell carcinoma, which will be used as a model of study of tumor~     vasculature.~      This new concept of tumor perfusion artificial increase could be used in the future for~     malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus~     decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like~     radiotherapy and/or chemotherapy, and increase their efficacy.~      This clinical trial will use skin flap model for trunk and facial basal cell carcinoma~     (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local~     anesthesia, a little random pattern skin flap will be raised around the BCC, then the~     cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.~      In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to~     the BCC location.~      During all steps of experimentation, laser speckle imaging will be used to measure~     continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10~     minutes after tumor pedicle clamp or tourniquet release.~   "
122274|NCT01455350|"~     Chronic gynaecological pain is a major medical problem that affects 20-30% of women at~     different moments of their life. This largely neglected issue has a significant impact on~     the sexual and conjugal life of women suffering from it as well as on their psychological~     health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even~     totally ignored. Also, treatment is limited and not extensively studied. This study aims at~     better understanding and treating gynaecological pain. The focus of the study will be~     provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic~     floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva.~     The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering~     from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital,~     Royal-Victoria Hospital, CHUM St-Luc).~   "
122275|NCT01455337|"~     Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease.~     Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate.~     Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve~     cytokine release and the perpetuation of injury by immunologic process, corticosteroid has~     been extensively evaluated in the treatment of alcoholic hepatitis. Although there are~     discrepancies in literature as several randomized trials and meta-analyses have reached~     contradictory results, corticosteroid for a subset of patients with severe alcoholic~     hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant~     gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been~     recommended. This latter point emphasizes the important of meticulous selection to avoid the~     side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly~     selected minority group in which the inhibitory effect of corticosteroid on liver~     inflammation is not outweighed by side effects such as weakened defense against infection,~     anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal~     bleeding, which may be deleterious in these critically ill patients.~      Newer understanding of the role of the role of TNF-α expression and receptor activity in~     alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to~     corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor,~     recently has been demonstrated in a randomized trial to improve survival in the therapy of~     severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to~     be related to a significant reduction in development of hepatorenal syndrome. These results~     are promising, and support the need to further evaluate the potential of this new~     therapeutic avenue.~      There is a need for head to head comparison of corticosteroid and pentoxifylline in severe~     alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was~     first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate~     that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone,~     an active form of prednisone. The aim of the present study was thus to compare the effects~     of pentoxifylline and prednisolone on the short-term mortality.~   "
122276|NCT01455324|"~     The purpose of this study is to work with prosthetists to fit the novel conformable socket~     material developed by Infoscitex, to subjects, and determine if it is a viable alternative~     to current prosthetic socket liners. During this task, the research team will travel to the~     prosthetists locations to have them fit the subject with the conformable woven socket and a~     check socket, and provide subjective feedback with regard to comfort and fit for the~     amputee, its ease of use, and breathability. The subject will also wear the woven socket for~     gait analysis and provide his/her feedback as well.~   "
122277|NCT01455311|"~     The goal of this study is to compare a sample of the cyst taken by a standard method (fine~     needle aspiration) to the sample taken by a new method using a device called the EchoBrush~     to see which method is more accurate at diagnosing cancer. We will also look at proteins~     (also called biomarkers) in the samples to see if they predict whether or not the cyst is~     cancerous.~   "
122278|NCT01455298|"~     This cohort study will evaluate the prevalence of the infra clinical liver injuries among a~     group of adult patients presenting with Alpha-1 AT deficiency followed up in a large~     university hospital in Lyon, France.~   "
122279|NCT01455285|"~     Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical~     nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency~     modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A~     controlled clinical study and prospective developed at the School of Physiotherapy Clinic /~     UFPI. Forty students were randomized into four distinct groups of the modulation frequency~     TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off),~     group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire~     developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60~     minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration~     of TENS application was 20 minutes and all protocols were performed in a single session. The~     analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify~     differences between experimental groups for each variable analyzed. The level of~     significance was p< 0,05.~   "
122280|NCT01455272|"~     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,~     option for the treatment of leukemia, particularly for patients with advanced-stage~     leukemia. However, relapse rate was still very high for advanced-stage leukemia.~      It was found in our previous study that infusion of granulocyte colony-stimulating factor~     (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes~     exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or~     less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was~     combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of~     fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI~     combined with the use of short-term immunosuppressant was feasible in patients with advanced~     leukemia to prevent relapse after HLA-mismatched HSCT.~      The study hypothesis:~      Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood~     progenitor cells following hematopoietic stem cell transplantation in patients with~     advanced-stage acute leukemia can~        -  reduce relapse rate~        -  improve survival~   "
122281|NCT01455259|"~     In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In~     Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients~     with melanoma and patients with other solid tumors will receive AdCD40L in combination with~     low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in~     combination with one local radiotherapy and cyclophosphamide.~   "
122282|NCT01455246|"~     Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug~     resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is~     to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.~   "
122283|NCT01455233|"~     The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and~     tolerance when used prophylactically in subjects undergoing routine cataract surgery.~   "
122284|NCT01455220|"~     The purpose of this study is to determine if sexual dysfunction symptoms and quality of life~     measures in patients with Multiple Sclerosis may be improved in patients that are prescribed~     Tysabri.~   "
122285|NCT01455207|"~     This research project aims to identify factors that contribute to the heterogeneity observed~     in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators~     overarching hypothesis is that the heterogeneity of alcoholic consequences on brain~     structure and metabolism, and cognition is mainly related to individual differences in~     pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.~   "
122286|NCT01455194|"~     The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day.~     Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).~   "
122287|NCT01455181|"~     This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in~     reducing requirements for supplemental oral calcium and active vitamin D, while maintaining~     stable total serum calcium levels in adult subjects with hypoparathyroidism.~   "
122288|NCT01455168|"~     The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in~     preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS)~     with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA)~     with an intraocular lens (IOL) implantation. All operations are performed by a single~     surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three~     groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted~     and closed by tying both eyelets in group C. The areas of continuous curvilinear~     capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among~     the 3 groups are tested.~   "
122289|NCT01455155|"~     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death~     and affects health care system in our country. The focal brain lesions encountered in~     patients with stroke can result in impairments in motor function, language, cognition,~     sensory processing, cognition and emotional disturbances. All of these conditions affect~     performance of functional activities. The abrupt change in the life situation of the stroke~     survivor impacts all phases of care. This may reduce a patient's quality of life.~      Many innovative therapy techniques have been developed to help the restoration of lost~     functions and to aid in prevention and treatment of depression. Music and art therapy has~     been used in rehabilitation settings to stimulate brain functions involved in movement,~     cognition, speech, emotions, and sensory perceptions. However many research studies on the~     use of music and art therapy in rehabilitation of acquired brain injury have suffered from~     small sample size, making it difficult to achieve statistically significant results. In~     addition, differences in factors such as study designs, methods of interventions, and~     intensity of treatment have led to varying results.~   "
122290|NCT01455142|"~     This trial is conducted in Europe. The aim of the trial is to test for bioequivalence~     between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy~     and safety obtained with formulation 1 can be assumed identical for formulation 2.~   "
122291|NCT01455129|"~     Chronic obstructive pulmonary disease (COPD) is one of the commonest respiratory diseases.~     During the early stage of COPD, patients only have mild respiratory symptoms or signs which~     may lead to under-diagnosis of the disease. Patients may show poor response to treatment at~     later stages of the disease, associated with higher mortality and incidence of~     re-hospitalization and disability causing burden for both the families and the society.~      So far, there is no large-scale clinical trial on long-term intervention with tiotropium~     bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or~     asymptomatic COPD). It would be of great significance for COPD prevention and treatment if~     the investigators could prove that tiotropium decreases the lung function decline and~     reverses disease progression in patients with early-stage COPD.~      The investigators objective is to evaluate the efficacy of long-term intervention with~     tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of~     exacerbations, time to first exacerbation, quality of life, etc) and relevant~     pharmacoeconomic endpoints.~   "
122292|NCT01455116|"~     Septic shock is in critically ill patients is a condition associated with a high rate of~     organ failure and hereto attributable mortality ~45-55% Hypothesis: Mild Induced Hypothermia~     reduces the mortality of critically ill patients with septic shock by reducing organ~     metabolism, counteracting on microcirculatory thrombosis, genetically downregulating tissue~     apoptosis and by reducing bacterial growth rate and toxin production.~   "
122293|NCT01455103|"~     The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on~     the biomarkers measured in the peripheral blood and tumor tissues of subjects with~     unresectable Stage III or IV Melanoma.~   "
122294|NCT01455090|"~     The purpose of this study is to estimate the rate of sustained virologic response (SVR)~     SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks~     post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1)~     infected patients who are prior null responders to pegIFN/ribavirin~   "
122295|NCT01455077|"~     Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters~     (level III of ASDA) has been validated in subjects with high probability of Obstructive~     Sleep Apnea (OSA) without comorbidities.~      However, there is not any study evaluating this system when OSA is associated with morbid~     obesity, so the validation of PMS will be very useful in order to properly work-up this~     highly risk population.~      Objective:~      To evaluate the accuracy of level III type of PMS - Stardust™ (STD), on patients with level~     II and III of obesity and high clinical suspicion of OSA.~      Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be~     selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the~     following order of recordings:~      1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken~     for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.~   "
122296|NCT01455064|"~     This research study will test a new investigational continuous glucose monitoring system~     (System). The purpose of this study is to find out about the performance of the System in a~     home use environment over a 15 day period, in people with diabetes.~   "
122321|NCT01454739|"~     The primary objective of the study is to evaluate the long-term safety of recombinant human~     Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary~     objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and~     treatment of bleeding episodes in participants with hemophilia A.~   "
122322|NCT01454726|"~     The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in~     patients with Meniere's disease.~   "
122297|NCT01455051|"~     A good proportion of patients with chronic lymphocytic leukemia (CLL) can be managed~     effectively with palliative chemotherapy. However, there is a group of younger patients with~     poor risk disease whose life expectancy is significantly reduced. As a result, reduced~     intensity conditioning (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) has~     been investigated as a potentially curative procedure.~      Recently, the European Group for Blood and Marrow Transplantation (EBMT) published a set of~     guidelines suggesting situations where allo-HCT might be considered a therapeutic option for~     CLL patients. Their conclusions were that allo-HCT was reasonable for younger CLL patients~     refractory to fludarabine, relapsing within two years of intensive treatment, or with p53~     abnormalities requiring treatment.~      However, the results with RIC allo-HCT are not entirely satisfactory, and progression-free~     survival after allo-HCT revolves around 35-40% at 3-5 years following allo-HCT. This is due~     to non-relapse mortality, which is significantly associated with the development of~     graft-versus-host disease (GVHD), but also due to disease relapse. These relapses may occur~     early in the course of the transplantation, like any other hematological malignancy, but~     late relapses have also been reported.~      Several strategies have been tested in order to improve these results. The anti-CD20~     monoclonal antibody rituximab, given concomitantly with allo-HCT or donor lymphocyte~     infusions, may reduce graft-versus-host disease and facilitate disease control. This may be~     due, not only to direct cytotoxicity, but also to modulation of GVHD and the graft-versus~     CLL effect (GVCLL). Interestingly, rituximab has been shown to promote the~     cross-presentation of tumor-derived peptides by antigen-presenting cells, thus enhancing the~     formation of cytotoxic T-cell clones and a GVCLL effect. With the addition of rituximab to~     the conditioning regimen, rates at 4 years for current progression-free survival (CPFS) and~     overall survival were 44% and 48%.~      The investigators hypothesize that ofatumumab, having a more potent anti-CLL activity and~     complement-dependent cytoxicity than rituximab, could improve disease control and modulate~     the GVCLL effect more effectively, thus reducing the GVHD rate and subsequently improving~     the non-relapse mortality and progression-free survival in the long term.~   "
122298|NCT01455038|"~     The purposes of this study were: (1) to compare heart rate variability between bipolar~     patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation~     between the severity of subsyndromal depressive symptoms and reduced heart rate variability.~   "
122299|NCT01455025|"~     This is a phase 1, dose escalation study of Plerixafor in combination with~     granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with~     relapsed acute myeloid leukemia .~   "
122300|NCT01455012|"~     Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS)~     have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been~     shown to effectively reduce the incidence of PLMs in patients with RLS. The current study~     aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal~     BP elevations associated with PLMs in patients with RLS.~   "
122301|NCT01454999|"~     This project aims to enhance the emotional and physical well-being of veterans through the~     reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with~     feedback messages delivered via cell phone. CTIs have shown increasing promise as useful~     behavior change programs for improved health behaviors. A variety of modalities are to~     deliver personalized CTI information and feedback; however, the ubiquity and sophistication~     of today's wireless mobile technologies represent new modes of delivery for empirically~     based smoking cessation and other behavioral health interventions. The CTI is based on the~     empirically-supported Transtheoretical Model of Behavior Change (TTM). A web-based CTI~     modified for a veteran population will be used to pilot test the effectiveness of the CTI~     alone and CTI plus individualized text messaging enhancements. The pilot study is a~     randomized controlled trial to assess the cell phone's feasibility as an intervention~     modality for changing smoking behaviors. This will be the first study to adapt a smoking~     cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce~     smoking behaviors in military veterans.~   "
122302|NCT01454986|"~     The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose~     of ALXN1007 in healthy volunteers.~   "
122303|NCT01454973|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
122304|NCT01454960|"~     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of~     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.~     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum~     antibiotics can lead to the development of resistant strains. Though providers are~     adequately trained to know when antibiotics are and are not comparatively effective, this~     has not been sufficient to affect critical provider practices.~      The intent of this study is to apply behavioral economic theory to reduce the rate of~     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call~     for antibiotics. Specifically targeted are infections that are likely to be viral.~      The objective of this study is to improve provider decisions around treatment of acute~     respiratory infections.~      The participants are practicing attending physicians or advanced practice nurses (i.e.~     providers) at participating clinics who see acute respiratory infection patients. A maximum~     of 550 participants will be recruited for this study.~      Providers consenting to participate will fill out a baseline questionnaire online.~     Subsequent to baseline data collection and enrollment, participating clinic sites will be~     randomized to the study arms, as described below.~      There will be a control arm, with clinic sites randomized in a multifactorial design to up~     to three interventions that leverage the electronic medical record: Order Sets that are~     triggered by EHR workflow containing exclusively guideline concordant choices (AP, for~     Alternative Prescriptions); Justification Alerts triggered by discordant prescriptions that~     populate the note with provider's rationale for guideline exceptions (JA); and performance~     feedback that benchmarks providers' own performance to that of their peers (SN, for social~     norms).~      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates~     and changes in prescribing rates over time.~      The intervention period will be over one year, with a one-year follow up period to measure~     persistence of the effect after EHR features are returned to the original state and~     providers no longer receive email alerts.~   "
122305|NCT01454947|"~     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of~     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.~     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum~     antibiotics can lead to the development of resistant strains. Though providers are~     adequately trained to know when antibiotics are and are not comparatively effective, this~     has not been sufficient to affect critical provider practices.~      The intent of this study is to apply behavioral economic theory to reduce the rate of~     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call~     for antibiotics. Specifically targeted are infections that are likely to be viral.~      The objective of this study is to improve provider decisions around treatment of acute~     respiratory infections.~      The participants are practicing attending physicians or advanced practice nurses (i.e.~     providers) at participating clinics who see acute respiratory infection patients. A maximum~     of 550 participants will be recruited for this study.~      Providers consenting to participate will fill out a baseline questionnaire online.~     Subsequent to baseline data collection and enrollment, participating clinic sites will be~     randomized to the study arms, as described below.~      There will be a control arm, with clinic sites randomized in a multifactorial design to up~     to three interventions that leverage the electronic medical record: Order Sets that are~     triggered by EHR workflow containing exclusively guideline concordant choices (AP, for~     Alternative Prescriptions); Justification Alerts triggered by discordant prescriptions that~     populate the note with provider's rationale for guideline exceptions (JA); and performance~     feedback that benchmarks providers' own performance to that of their peers (SN, for social~     norms).~      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates~     and changes in prescribing rates over time.~      The intervention period will be over one year, with a one-year follow up period to measure~     persistence of the effect after EHR features are returned to the original state and~     providers no longer receive email alerts.~   "
122306|NCT01454934|"~     This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety~     of eribulin with TPC in subjects with advanced and disease progression following at least~     two prior regimens for advanced disease, which should have included a platinum-based~     regimen.~   "
122307|NCT01454921|"~     This study will develop/adapt a culturally appropriate secondary prevention intervention for~     young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups,~     evaluate its acceptability and feasibility, make appropriate modifications, and manualize~     the intervention in preparation for a full-scale randomized trial.~      Once the intervention is developed/adapted, the sites will pilot the interventions twice to~     enable modifications. The intervention aims to address the following concerns: 1) reducing~     the risk of young women infected with HIV transmitting the virus to their sexual partners,~     and 2) preventing young women infected with HIV from re-infection with a new viral strain or~     co-infection with another sexually transmitted disease (STD). Data will be collected to~     assess the feasibility and acceptability of the newly developed intervention using both~     quantitative and qualitative methods at each iteration.~   "
122308|NCT01454908|"~     The objective of this study is to compare the effect on gait of unicompartmental knee~     arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.~   "
122309|NCT01454895|"~     The purpose of this project is to compare the effectiveness of several approaches to~     influencing hearing protector use. The goals of this study are to further develop an~     intervention to promote farmers' use of hearing protectors, and compare the effectiveness of~     the developed intervention with two alternative approaches to influencing hearing protector~     use behavior, delivered in various combinations. This study will determine if significant~     change in hearing protection use can be achieved in a one-shot web-based or protector-supply~     intervention. Results will determine the need for future program modifications, e.g.,~     inclusion of booster(s).~   "
122310|NCT01454882|"~     Although instruments such as pedometers and heart rate monitors are helpful for those who~     use exercise to maintain their weight, they do not actually measure calories expended, which~     is a critical piece of information necessary for sustained weight management. The purpose of~     this study is to determine the accuracy of a new device that measures calories burned based~     upon heat produced by the body. Since heat production is directly proportional to calories~     burned, this device has the potential to accurately measure energy expended in many~     different settings.~   "
122311|NCT01454869|"~     This is a prospective randomized clinical trial about the efficacy of heparin nebulization~     on lung injury score in inhalation burn injury in Mothary burn hospital. This study would~     consist of 170 burn patients with documented inhalation injury in 2 arms (control group and~     study group). Allocation ratio is1:1. Masking was not possible. The patients' primary~     outcome will be assessed for Lung Injury Scale and the patients' secondary outcome will be~     assessed for mortality, Coagulation tests (PT, PTT), ICU and hospital stay and duration of~     mechanical ventilation support. Duration of this study is about 32 months.~   "
122312|NCT01454856|"~     This study consists of evaluations, using blood tests, various immune, inflammatory and~     coagulation parameters in the perioperative settings (different substudies), without~     changing anything to what is expected.~      This will allow us to clarify the possible impact of surgery and analgesia on perioperative~     activation of these pathways.~   "
122313|NCT01454843|"~     The purpose of the study is to compare the results of LASIK surgery when using Alcon~     Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom~     wavefront-guided excimer laser system in patients with nearsightedness with and without~     astigmatism.~   "
122314|NCT01454830|"~     The purpose of this study is to examine the feasibility of a tailored (i.e., individualized)~     intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in~     adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.~   "
122315|NCT01454817|"~     The purpose of this study is to better understand symptoms and quality of life in patients~     with heart disease and implantable defibrillators (ICDs).~   "
122316|NCT01454804|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients~     with advanced cancer. The safety of the drug combinations will also be studied.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2~     proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.~      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking~     proteins inside the cancer cell, called the Her2/neu receptor.~   "
122317|NCT01454791|"~     The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on~     injection site reaction following self-administer glatiramer acetate in people with Multiple~     Sclerosis.~   "
122318|NCT01454778|"~     This is a single, one time, limited dose infusion of Paclitaxel, that will potentially~     prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control~     group at 10 months.~   "
122319|NCT01454765|"~     Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex~     and therefore limits genetic research approaches in biomedical models. To overcome this~     problem experimental generation of haploid stem cells has been done in animals. The~     investigators aim at generating haploid stem cells from human germ cells that are a useful~     tool in genetic research and screening.~   "
122320|NCT01454752|"~     Although the risk of malaria is greatest in early childhood, significant numbers of~     schoolchildren remain at risk from malaria infection, clinical illness and death. By the~     time they reach school, many children have already acquired some clinical immunity and the~     ability to limit parasite growth, and thus most infections are asymptomatic and will go~     undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing~     concentration and learning in the classroom, and interventions aiming to reduce asymptomatic~     parasite carriage may bring education, as well as health, benefits.~      Intermittent parasite clearance (IPC) delivered through schools is a simple intervention,~     which can be readily integrated into broader school health programmes, and may usefully~     supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a~     policy of universal coverage of nets.~      This study seeks to establish whether intermittent parasite clearance undertaken once a year~     at the end of the malaria transmission season can reduce malaria parasite carriage and~     anaemia amongst school-going children already using insecticide-treated nets, and its~     consequent impact on school attendance and performance, in order to assess its suitability~     for inclusion as a standard intervention in school health programmes in areas of seasonal~     malaria transmission.~   "
122324|NCT01454700|"~     The purpose of the study is to investigate whether the combination of insulin pump therapy~     and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to~     prevent progression of albuminuria in patients with type 1 diabetes~   "
122325|NCT01454687|"~     The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases~     associated with skin weakness, blisters, and chronic wounds. Revertant mosaicism means~     that there are two genetically different populations of cells due to spontaneous mutations.~     Some EB patients have normal, non-fragile skin patches which may be areas of revertant~     mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this~     study, we plan to culture cells from the revertant areas and graft them on to the wounded~     areas.~   "
122326|NCT01454674|"~     The investigators have designed a three dose level, cross-over vegetable feeding study using~     expertise from nutritional sciences and plant sciences to:~        1. Implement a randomized vegetable feeding trial among overweight post- menopausal women~        2. Produce, in a controlled environmental setting, vegetable crops which provide a~          selected variety and quantity of carotenoid and nutrient exposure~        3. Assess changes and hopefully demonstrate a significant reduction in oxidant stress and~          inflammation in this population at risk for developing chronic disease~   "
122327|NCT01454661|"~     Probiotics are live microbes which, when administered in sufficient amounts, confer a health~     benefit to the host. According to recent clinical trials, administration of probiotics to~     very low birth weight infants significantly reduces overall mortality and risk of~     necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators~     have previously demonstrated that administering probiotics to the lactating mother enhances~     the immunoprotective properties of breast milk. Despite the promising data, the optimal~     probiotic intervention is yet to be established. The mechanisms by which probiotics exert~     their effects remain largely unknown.~      This research project is based on the notion that modulation of early microbial contact by~     probiotics may provide a safe and effective means to improve the health of preterm infants.~     In particular, the investigators hypothesize that the protective potential of probiotics may~     be enhanced via breast milk by administering probiotics to the lactating mother. All of the~     potentially beneficial effects of probiotic bacteria are strain-specific and therefore~     preliminary laboratory and clinical research with regard to different physiological targets~     of probiotic intervention should be carried out to guide the design of large-scale clinical~     trials aiming show clinical efficacy and establish clinical practice. The purpose of this~     research project is to identify targets for probiotic therapy in premature neonates and to~     provide insight into the optimal probiotic strains and administration protocol the clinical~     efficacy of which will subsequently be tested in a randomized controlled trial.~      The specific aims of the project are:~        1. To determine the effect of maternal consumption of probiotics during lactation on~          immunomodulatory properties of breast milk in mothers of premature infants.~          Concentrations of immunomodulatory factors and microbiological properties of breast~          milk will be measured.~        2. To investigate the impact of different probiotic administration protocols on gut~          microbiota composition in preterm infants. In particular, the issue whether maternal~          probiotic consumption instead or in addition to probiotics administered to the infant~          is effective will be elucidated. Different potential probiotic strains will be~          assessed.~        3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or~          directly to the infant on gut immunophysiology in preterm infants.~   "
122328|NCT01454648|"~     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit~     treatment methods on traumatic brain injury (TBI) patient prognosis.~   "
122329|NCT01454635|"~     The purpose of this study is to predict and visualize sertraline treatment response in major~     depressive disorder with clinical symptoms, demographic and stress state, personality, eight~     genetic polymorphisms at baseline.~   "
122330|NCT01454622|"~     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)~     tablets of canagliflozin and metformin immediate release (IR) in comparison with the~     individual components of canagliflozin and metformin IR.~   "
122331|NCT01454609|"~     With thyroid surgery being performed as an ambulatory procedure, most recent studies~     concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral~     superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep~     cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence~     the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without~     clonidine in thyroidectomy, as preemptive analgesia.~      The hypothesis was bupivacaine with the addition of clonidine would help in reducing~     postoperative pain and thereby reduce the need for postoperative analgesia.~   "
122332|NCT01454596|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     gliomas that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying these specific cells with a type of virus~     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.~     This type of therapy is called gene transfer. In this protocol, we are modifying the patient~     s white blood cells with a retrovirus that has the gene for anti-EGFRvIII incorporated in~     the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-EGFRvIII cells) are a safe and effective~     treatment for advanced gliomas.~      Eligibility:~      - Adults age 18-70 with malignant glioma expressing the EGFRvIII molecule.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed~      Leukapheresis: If the patients meet all of the requirements for the study they will undergo~     leukapheresis to obtain white blood cells to make the anti-EGFRvIII cells. {Leukapheresis is~     a common procedure, which removes only the white blood cells from the patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for~     the conditioning chemotherapy, the anti-EGFRvIII cells, and aldesleukin. They will stay in~     the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans every month for the first year, and then every 1-2 months as long as~     their tumors are shrinking. Follow up visits will take up to 2 days.~   "
122333|NCT01454583|"~     In Germany nearly half of the population present elevated values of blood pressure, with -~     as a result of lifestyle factors and a growing average age - further increasing numbers.~      Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular~     events, and renal insufficiency. Thus, hypertension therapy focuses on the reduction of~     these complications.~      The aims of the 3A-registry are the characterization of outpatients with hypertension, their~     diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance~     and success, clinical events, and an assessment of overall guideline adherence in the~     treatment of these patients.~      Patients fulfilling the relevant criteria are enrolled and followed up by their general~     practitioner or medical specialist.~   "
122489|NCT01452555|"~     The purpose of the study is to determine if a Spanish-language HIV and HIV test information~     video is as effective in delivering basic information regarding HIV and HIV tests to~     primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test~     counselor.~   "
122334|NCT01454570|"~     It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to~     many secondary medical problems such as diabetes and insulin resistance, obesity,~     constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of~     life, and more. The ReWalk-I exoskeleton walking device permits investigation of the~     potential benefits of frequent upright posture and walking on many of the secondary~     consequences of spinal cord injury. The researchers are investigating the ability of persons~     with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being~     upright and walking on several of these secondary medical consequences of spinal cord~     injury.~   "
122335|NCT01454557|"~     Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an~     external stimuli. The aim of this system is to maintain homeostasis.The variability implies~     on the interaction between the sympathetic and the parasympathetic systems to maintain the~     ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be~     a damage to the Central Nervous System (CNS) function. The damages described in the~     literature are cognitive, motor and behavioural function, while there is less relation to~     the autonomic system. The autonomic system can influence the ability of patient with ABI to~     participate in the rehabilitation program. The aim of this work is to investigate the~     activity of the autonomic system activity as manifested by HRV among patients with ABI in~     different conditions: resting, during activity and while listening to different auditory~     stimuli.~   "
122336|NCT01454544|"~     The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet~     given once daily compared to a placebo tablet in the treatment of house dut mite allergic~     rhinits.~      Additionally the secondary objective of the trial is to evaluate the safety and tolarability~     of the ALK house dust mite tablet.~      Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust~     mite induced allergy. This trial is planned to investigate if clinically relevant~     improvements in rhinitis symptoms and with less use of symptomatic medication can be~     obtained in subjects with a history of poor didease control despite of use of symptomatic~     medications.~   "
122337|NCT01454531|"~     The purpose of this study is to assess the tolerability of AVANZ.~   "
122338|NCT01454518|"~     The purpose of this study is to examine if ultrasound guided infiltration of local~     anesthetic solution around the hip joint will provide effective pain control after hip~     arthroscopy.~   "
122339|NCT01454505|"~     The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A)~     and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis~     (Stage B).~   "
122340|NCT01454492|"~     Allergic rhinitis is a complex chronic inflammatory disease, it always presents with nasal~     obstruction, nasal itching, sneezing and runny nose. Whether in adults or children, rhinitis~     is a complex disease. The prevalence of allergic rhinitis in Taiwan is about 24-29%. Taiwan~     is a developing country. It is a hot and humid country. In developing countries,~     industrialization, air pollution makes the constantly increasing number of patients with~     rhinitis. Penghu in 1994 for children aged 7 to 14 by the study found that among 7599~     people, 1766 people have allergic rhinitis, about 23.2%. Allergic rhinitis is a complex~     chronic disease. So, it become a diagnostic challenge, its prevalence always underestimated.~     The prevalence of rhinitis has increased in recent years. The phenomenon of underestimate is~     caused by variety of personal and environmental factors. Allergic rhinitis had increased~     direct and indirect social and economic burden.~      Geographic tongue is a benign tongue performance. Geographic tongue has been reported their~     relevance to allergy. Geographic tongue is a chronic tongue situation. The causes of~     geographic tongue still remains unknown. Allergic rhinitis is a diagnostic challenge to~     clinicians. The investigators hope that geographic tongue could play a role in the~     diagnostic of allergic rhinitis. The prevalence of geographic tongue in the United States is~     about 1.8%, white Americans and Mexicans have a higher incidence rate. This study will~     investigate the relevance between allergic rhinitis and geographic tongue. The investigators~     will analyze the relevant gender, age, severity of inspection reports. The research results~     wound provide an important reference to the diagnosis of allergic rhinitis.~   "
122341|NCT01454479|"~     Endometrial cancer (EC) is the 8th most common female cancer in Taiwan. Its incidence is~     increasing in the recent few years, around 1,200 new cases per year. The outcome of~     recurrent EC is disappointing, except focal recurrences that could be irradiated or removed.~     Chemotherapy is currently the most common salvage treatment for recurrent endometrial~     cancer. However, the response rate (RR) to 2nd-line treatment is approximately 0-27.3%, with~     short median time to progression, 2-3.9 months and low overall survival, 6.4-11 months.~      Due to progress of studies on the molecular and genetic basis of cancer and cellular~     signaling pathways, targeted therapy has been developed for various cancer treatments. A~     Gynecologic Oncology Group study found 44% of advanced endometrial cancer had HER>=2+ and~     the ratio of HER2:chromosome 17 (CEP17) >=2. Another study showed that HER>=2+ was seen in~     47% of carcinosarcoma. These evidences indicated HER2 gene amplification and HER2~     overexpression occur in endometrial cancer and carcinosarcoma, especially in those of high~     grade and recurrence. Lapatinib (L), an oral inhibitor of both EGFR(epidermal growth factor~     receptor) and HER2(human epidermal growth receptor), has been shown to be an effective~     treatment in HER2/neu overexpressing metastatic breast cancer. Ixabepilone is a~     semisynthetic analog of the natural product epothilone B, and recently has been approved by~     US Food and Drug Administration as a treatment option in metastatic breast cancer. It was~     also observed that lapatinib + ixabepilone killed more breast tumor cells than trastuzumab +~     paclitaxel in vitro. Two GOG(Gynecologic Oncology Group) studies had reported that weekly~     Ixabepilone as 2nd-line chemotherapy provided a similar RR to 3-weekly regimen of 14.3% in~     platinum- and taxane-resistant epithelial ovarian cancer with less severe toxicities. The~     combination of lapatinib and ixabepilone is expected to become an effective treatment for~     recurrent endometrial cancer and carcinosarcoma, but the ideal dose is yet to be surveyed.~   "
122342|NCT01454466|"~     To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal~     breaks related to induction of a posterior vitreous detachment~   "
122352|NCT01454336|"~     Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is~     the only effective therapy available to these patients. However, limited number of donors,~     post surgical complications, immunological rejection, and financial considerations are it`s~     essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and~     several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this~     research the investigators will study the affect of MSCs and Pioglitazone in the process of~     fibrosis.~   "
122433|NCT01453322|"~     The objective of this study is to confirm and document that with the use of a FDA Class I~     exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for~     healthy adult volunteers with varying skin types to assist in the improved visualization, it~     is possible to film, analyze and document PIV localized complications and venous flow and~     refill.~   "
122343|NCT01454453|"~     Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and~     distressing symptoms in older people. Although these drugs can be beneficial, they are~     associated with side effects, particularly in patients with dementia and schizophrenia- like~     illness. There is an urgent clinical need to understand why this is the case, to guide~     treatment strategies.~      This study aims to utilise brain imaging techniques that measure the action of antipsychotic~     drugs in the brain to explore the causes of this susceptibility in older people with~     dementia and schizophrenia-like illness, and translate these findings into direct patient~     benefit.~      The aim of the study is to investigate and compare the relationship between the action of~     amisulpride at brain sites and clinical response (symptom reduction and side effect profile)~     during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's~     disease and schizophrenia-like illness. Imaging data will be combined with data on drug~     dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor~     side effects) during dose titration.~      Non-linear mixed effect modelling will be used to establish the minimum clinically effective~     dose of amisulpride, optimum dose range and impact of variability and covariates on~     exposure-response relationships in the 2 patient groups~      This information will be used make predictions about amisulpride prescribing of other~     antipsychotic drugs to the two patient groups.~   "
122344|NCT01454440|"~     Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33~     mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin~     according to the ESPRIT protocol vs placebo plus unfractioned heparin.~   "
122345|NCT01454427|"~     Impedance aggregometry (IA) (Multiplate®)is a new whole blood platelet function test with~     potential use in anesthesia and intensive care. Most anesthetic drugs have been shown to~     have in vitro antiplatelet activity. The goal of this in vitro study is to evaluate the~     effect of several drugs, frequently used in cardiac anesthesia and intensive care, on~     platelet function as measured by IA~   "
122346|NCT01454414|"~     The high risk of acquiring tick-borne diseases by outdoor workers is well documented.~     Workers most at risk include, foresters, park rangers, land surveyors and other outdoor~     workers have frequent exposure to tick-infested habitats. Many North Carolina state~     employees with outdoor occupations report multiple tick bites each year, which indicates~     that existing tick preventive strategies may be ineffective. The principal goal of this~     study is to assess whether the use of long-lasting permethrin impregnated uniforms can~     reduce the number of tick bites sustained by North Carolina outdoor workers.~   "
122347|NCT01454401|"~     The LeucoPatch™ study goal is to investigate whether the fully autologous growth~     factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic~     foot ulcers. The study seeks to gather data for comparison with previous data from similar~     wounds (historical controls). By subgrouping of the treated wounds (similar to the~     historical controls used) an assessment of which of the patient and wound-related factors~     that might indicate a beneficial effect of LeucoPatch™ is sought.~   "
122348|NCT01454388|"~     In addition to bowel cleansing agents, the current practice of bowel preparation for~     colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day~     before the procedure. This study aims to test whether patients who consume a low residue~     breakfast the day prior to colonoscopy have a difference in the quality of their bowel~     preparation. Patients requiring outpatient colonoscopies will be asked to participate. They~     will be randomized to either breakfast or no breakfast the day before the procedure. Colon~     cleanliness, patient hunger, and tolerance will be assessed.~      The investigators hypothesize that there will be no difference in bowel preparation scores~     and will be better tolerated~   "
122349|NCT01454375|"~     Tobacco smoke claims approximately 6000 lives annually in BC. In this study, the~     investigators will determine whether referring smoking patients from the Vancouver General~     Hospital Emergency Department to the investigators provincial QuitNow smoking cessation~     service will lead to improved patient outcomes, including number of cigarettes smoked, any~     quit attempts, and actual smoking cessation.~      Participants in the usual care arm will receive standard care. Participants in the~     intervention arm will be eligible for referral to QuitNow Services, where telephone~     counseling will be offered. Further follow-up on all enrolled patients will be conducted at~     1, 3, 6, and 12 months to re-assess smoking status.~      The investigators hypothesis is that the intervention arm will have a higher quit rate that~     the control arm.~   "
122350|NCT01454362|"~     Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour~     and may have a potential to assist smoking cessation. Among current treatments for smokers,~     only the nicotine inhalator is attempting to address such factors. The inhalator's efficacy~     does not exceed that of the other NRT products, but it mimics the relevant sensory input to~     only a limited extent, and its nicotine delivery is dependent on intensive puffing. Recently~     a new product, the Electronic Cigarette (E-C) has become available, which provides a more~     realistic behaviour and sensory replacement for smoking and can provide good nicotine levels~     with less effort.~      Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco~     withdrawal symptoms over 24hr abstinence.~      Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms~     and craving and elicit more favorable user ratings. It will also provide higher nicotine~     levels.~      Study design: In a cross-over study, participants will be randomized to the sequence of~     conditions and provide baseline measures and samples for salivary cotinine analysis. They~     will be asked to abstain from smoking their usual cigarettes and use the allocated product~     over 24 hours. They will return to the study centre the following day, and complete measures~     of craving and withdrawal, ratings of subjective and sensory effects of the products,~     product satisfaction, and adverse effects. They will also provide saliva samples for~     cotinine analysis. Abstinence from smoking will be verified with CO readings.~   "
122351|NCT01454349|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of a single~     treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to~     placebo.~   "
122378|NCT01453998|"~     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the~     booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and~     15 months of age, and the immune persistence following the primary series. All children in~     this booster study received a primary vaccination at 2, 3 and 4 months of age in study~     113948 (NCT01248884). No new subjects will be enrolled in this booster study.~   "
122353|NCT01454323|"~     Phase II clinical trial which will include all patients diagnosed with chronic anterior~     myocardial infarction (more than 6 months from the acute phase and the complete~     revascularization in which it is assessed the evolution of left ventricular function in~     patients to the monitoring against their own basal condition.~      Included patients will be studied in the following conditions:~        -  Basal condition: defined as the immediately preceding to the administration of cell~          therapy treatment.~        -  Monitoring Condition 1: three months after drug administration of cell therapy.~          Includes non-invasive methods of exploration of ventricular function.~        -  Monitoring Condition 2: six months after administration of treatment. Includes the same~          methods of exploration of ventricular function practised in the basal condition,~          including cardiac catheterism as well as non invasive methods.~        -  Monitoring Condition 3: twelve months after administration of the cell therapy drug.~          Includes non-invasive methods of exploration of ventricular function.~      The trial hypothesis we propose consists of mononuclear cells of bone marrow providing~     progenitor cells with regenerative capacity and also secreting several angiogenic factors,~     and their implantation into ischemic tissues should contribute with both elements to the~     angiogenesis and tissue regeneration with myocardial functional recovery~   "
122354|NCT01454310|"~     The purpose of the study is to compare an acellular epithelial skin substitute with~     autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The~     objective is to evaluate skin quality and scar formation by using subjective and objective~     burn scar assessments in order to present valuable data for another additional option of~     wound coverage in deep partial-thickness burns. The investigators hypothesized that the~     acellular epithelial skin substitute is at least not inferior to autologous skin grafts.~   "
122355|NCT01454297|"~     The primary objective of this observational study is to identify the molecular profiles and~     clinical characteristics that define subsets of myeloma patients during the course of the~     disease.~   "
122356|NCT01454284|"~     The purpose of this study is:~        -  To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of~          treatment.~        -  To compare the number of nocturnal low blood sugar episodes on LY2605541 with insulin~          glargine during 52 weeks of treatment.~        -  To compare the number of patients on LY2605541 reaching blood sugar targets without low~          blood sugar episodes at night to those taking insulin glargine after 52 weeks of~          treatment.~        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin~          glargine after 52 weeks of treatment~   "
122357|NCT01454271|"~     The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to~     be less than 1% but remains a severe and costly complication, source of morbidity and even~     mortality. The biofilm forms very early after the bacterial contamination of the~     prosthesis and poses a number of clinical challenges due to his resistance to immune defence~     mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene~     sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly~     sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial~     adhesion. They also proved his biocompatibility and osseous-integration.~   "
122358|NCT01454258|"~     This study evaluates which substitution solutions are used in daily clincal practice in~     various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan~     Region). Furthermore the indication for usage of these solutions is investigated.~   "
122359|NCT01454245|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability~     of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers.~     The effect of food on the pharmacokinetics of one of the capsule formulations of~     JNJ-39439335 will also be evaluated during the study.~   "
122360|NCT01454232|"~     Gut microbiota ecology is altered in obesity and could link obesity and its complications.~     Bariatric surgery enables a major and sustained weight loss therefore improving obesity~     related disease.~      the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and~     the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese~     patients post bariatric surgery to that of lean healthy volunteers.~      Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and~     after either restrictive (gastric banding) procedures or gastric bypass procedures to that~     of 40 lean healthy volunteers at baseline.~   "
122361|NCT01454219|"~     This study aims to determine the glycemic index, glycemic load and insulin index of eleven~     Fazer bakery and confectionary products.~   "
122362|NCT01454206|"~     The Goal of this project is to integrate a previously-tested internet-facilitated Screening,~     Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use~     into a large network of primary care offices, the Pediatric Practices of Children's Hospital~     Boston (PPOC).~   "
122363|NCT01454193|"~     The objectives of the data search is to find out if there is correlation between pre, post~     serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and~     associated changes in pre and post systolic and diastolic blood pressure, mean arterial~     pressure, number of blood pressure medications and adherence to 3 times per week dialysis,~     mortality.~   "
122364|NCT01454180|"~     The purpose of this study is to determine the proportion of patients alive after 12 months~     of the beginning of the trial in patients with advanced pancreatic carcinoma individually~     selected and grouped according to the expression in tumor tissue for therapeutic targets.~   "
122365|NCT01454167|"~     Objective- The purpose of this study is to evaluate a connection between~     PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic~     operational wounds and its relation to infections and seroma formation.~   "
122366|NCT01454154|"~     This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV~     RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or~     severe traumatic brain injury (TBI).~   "
122379|NCT01453985|"~     This is a prospective study to extensively evaluate subjective patient parameters on quality~     of life, reflux-symptoms, side effects, medication-use and measurements of esophageal~     manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.~   "
122542|NCT01451866|"~     A complex training on a dynamic leg-press with visual feed-back will improve coordinative~     capacity, power, sensorimotor and cognitive aspects more than a classic training on the same~     leg-press but without visual feed-back.~   "
122367|NCT01454141|"~     Depression is frequently characterized by patterns of inflexible, maladaptive, and~     ruminative thinking styles; these patterns themselves are thought to result from a~     combination of decreased attentional control, decreased executive functioning, and increased~     negative affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to~     play a central role in emotion regulation by recruiting resources necessary for executive~     control. Recent advances have been made in neurobehavioral training strategies as~     interventions for emotional disorders such as depression. Cognitive control training (CCT)~     uses computer-based exercises to recruit and activate prefrontal neural networks via~     repeated behavioral exercises, with the aim of strengthening cognitive and emotional~     functions. A previous study found that severely depressed participants who received CCT~     exhibited reduced negative affect and rumination as well as improved focus and~     concentration. The present study aimed to extend this line of research by employing a more~     stringent control group and testing the efficacy of three sessions of CCT over a two-week~     period in a community population with depressed mood. Forty-eight participants with high~     BDI-II scores were randomized to CCT or a comparison condition (Peripheral Vision Training;~     PVT). The investigators hypothesized that relative to a control condition (PVT), CCT would~     be associated with less self-reported negative mood and emotional reactivity.~   "
122368|NCT01454128|"~     Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an~     impaired regulatory function of multiple organ systems which were resulted from impaired~     cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary~     exercise test (CPET), the investigators found there is periodic oscillation in minute~     ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen~     uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were~     also noted. Exertional hyper-ventilation that is caused by HF may further induce~     vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle.~     Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic~     change during nadir phase of PB may deteriorate the exercise limitation. Physical training~     can have beneficial effects which can effectively counteract the progression of deleterious~     compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on~     ventilation oscillation and inefficacy is not clear.~      The investigators will observe the real-time cardiac and hemodynamic change respond to~     exercise with periodic breathing change. The investigators expect that these results~     obtained from this study can aid in determining appropriate exercise intervention to improve~     aerobic fitness as well as simultaneously improve hemodynamic control in patients with HF. A~     quasi-experimental design will be used in this investigation. 60 HF patients will be~     recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided~     informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by~     their expression of CPET. Patients from each groups received the same therapy and trace~     course for 2years including CV clinics, CPET and polysomnography. The investigators will~     measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal~     muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and~     aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at~     pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program.~     Experimental results were analyzed by descriptive statistics, independent t-test, and~     repeated measure ANOVA. The investigators study the above parameter to realize the~     physiological response to exercise of these patients and discover the appropriate exercise~     intensity for prescription for EPB.~   "
122369|NCT01454115|"~     The primary objective is to assess the safety and tolerability of a single oral dose of~     BMS-708163 in healthy young male subjects and in elderly male and female subjects.~   "
122370|NCT01454102|"~     There is no formal research hypothesis to be statistically tested in this protocol.~        -  The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when~          combined with three platinum-based doublet chemotherapy regimens~          (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects~          with NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy~          in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of~          platinum doublet chemotherapy.~        -  The study is evaluating the safety and tolerability of Nivolumab in combination with~          Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous~          NSCLC subjects and as monotherapy in subjects with NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab in combination with~          Ipilimumab in subjects with squamous and non-squamous NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as switch maintenance~          therapy in subjects with squamous and non-squamous NSCLC.~        -  The study is evaluating the safety and tolerability of Nivolumab as monotherapy among~          subjects with untreated, asymptomatic brain metastases and no evidence of cerebral~          edema.~   "
122371|NCT01454089|"~     The primary objective of this study is to ascertain whether there is evidence of longer~     survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control~     Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to~     control Arm.~   "
122372|NCT01454076|"~     This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB~     designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative~     bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3),~     drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin~     (Arm 5) in patients with advanced nonhematologic malignancies or lymphoma.~   "
122373|NCT01454063|"~     The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug)~     for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens~     Replacement (ILR) surgery.~   "
122374|NCT01454050|"~     The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family.~     Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which~     automatically measures the RV/LV threshold and subsequently adjusts the pacing output.~   "
122375|NCT01454037|"~     The change of immune profiles and existence of circulating tumor cells following prostate~     cryotherapy may be correlated with the clinical outcome.~   "
122376|NCT01454024|"~     This study is conducted in Asia. The aim of of this study is to evaluate the safety of~     NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of~     adverse events and technical complaints in patients with type 1 and type 2 diabetes in~     routine clinical practice.~   "
122377|NCT01454011|"~     The study is designed to answer the following questions:~        1. Is there any difference between the compositions of the HDL cholesterol subpopulations~          of patients with hypogonadism and the healthy controls.~        2. What is the effect of testosterone replacement therapy on the distributions of HDL~          subgroups.~        3. Is there any difference between the effects of the two different testosteron~          replacement regiments~   "
122431|NCT01453348|"~     This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine~     given alone or concomitantly with MenACWY-CRM to healthy adults.~   "
122380|NCT01453972|"~     The main purpose of our study is to examine the physiological adaptations in oxygen~     transport chain for high-intensity exercise and moderate exercise in overweight and obese~     humans. The main goals are:~        1. To investigate the most effective short-and long-interval training in terms of VO2max,~          pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.~        2. How these physiological adaptations affect the aerobic endurance and performance, and~          how this training can reduce the risk of cardiovascular diseases related to overweight~          and obesity.~   "
122381|NCT01453959|"~     The main hypothesis of this study is look for a clinical and fast test to identify salt~     sensitivity by administration of fludrocortisone.~   "
122382|NCT01453946|"~     A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.~   "
122383|NCT01453933|"~     Treatment with HIV-infection with protease inhibitors is associated with high blood lipids~     and higher chance for cardiovascular complications. The RASSTER study aims to investigate~     the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel~     wall function and inflammation,and activation of the immune system. we hypothesize that with~     this intervention these parameters will improve. Since decreased vessel wall function and~     inflammation are initial steps in the process of atherosclerosis, it is important to know~     this data when treating HIV-infected patients.~   "
122384|NCT01453920|"~     The current norm in clinical practice for the treatment of choroidal neovascular membranes~     (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of~     Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow~     one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable~     patients, with treatment thereafter only in the presence of disease recurrence.~     Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are~     extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend~     dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is~     possible that the subgroup of patients on every three months 'treat-and-extend' dosing may~     represent a uniquely, stable population that would perform particularly well on an~     observational regimen with regular follow-up. We hypothesize that there will be a low CNVM~     recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing~     ('treat-and-extend'), who begin a treat-and-observe protocol.~   "
122385|NCT01453907|"~     This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to~     65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study~     will be randomized, double-blind and stratified by gender. Each cohort will contain 36~     subjects (including at least four females), 30 who will receive ETI-204 and six who will~     receive placebo.~   "
122386|NCT01453894|"~     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)~     screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults,~     beginning at age 50 and continuing until age 75. However, rates of CRC screening remain~     inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening.~     Screening rates are even lower among Black and Hispanic populations and in areas with higher~     poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be~     effective. Few studies have examined the rate of repeat FOBT testing; to the investigators~     knowledge, none have been conducted in populations with high prevalence of barriers to~     screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The~     assumption that FOBT is an effective CRC screening strategy presumes it will be done at~     least biennially, and cost-effectiveness studies of CRC screening strategies have found that~     the results are sensitive to the rate of adherence. The investigators study will provide~     critical information for providers and policymakers as they consider optimal strategies to~     increase CRC screening among vulnerable populations.~      Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal~     occult blood testing (FOBT).~      Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a~     30-month period~      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of~     patients who complete a repeat annual FOBT within 6 months of their due date.~      Hypothesis 2: Compared to usual care, the intervention will increase the proportion of~     patients who complete 2 additional FOBTs over the 30-month intervention period.~      Aim 2: Explore perceived barriers to screening among patients who received the intervention~     but did not complete repeat FOBT testing within 18 months~      Aim 3: Assess the costs of the intervention and the costs per additional repeat screening~     compared to patients who received usual care.~   "
122387|NCT01453881|"~     Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered~     dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of~     different types and sizes have also been developed for use in combination with pMDI. The~     therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers~     can optimize lung deposition as it obviates lung-hand coordination and retain larger~     particles. The aim of this study is to compare the efficacy of the fine particle combination~     pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in~     patients without adequate asthma control on medium to high-dose inhaled steroids associated~     with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy~     difference between the two forms of drug administration.~   "
122388|NCT01453868|"~     Standing Balance, with and without blindfold, will be measured on patients with Multiple~     Sclerosis using a Biodex Balance Scale.~      A Twelve week intervention with one non impact aerobics group and one control group will be~     performed.~      Standing balance will then be retested on all subjects and the results will be statistically~     compared.~   "
122389|NCT01453855|"~     The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy~     of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma~     or ocular hypertension.~   "
122390|NCT01453842|"~     Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1~     (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol~     (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test~     the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a~     significant increased plasma GLP-1 following a meal containing of 2-OG when compared to~     meals containing of olive oil or carbohydrates alone.~   "
122391|NCT01453829|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients after Stroke and~          clinical outcomes?~   "
122392|NCT01453816|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Renal~          Failure and clinical outcomes~   "
122393|NCT01453803|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Parkinson's~          Disease and clinical outcomes.~   "
122394|NCT01453790|"~     This project is an investigator-initiated, randomized-controlled trial of the effectiveness~     of written and verbal parent-specific depression education and motivational advice in~     increasing participants self-disclosed intention to seek follow-up care for possible~     depression symptoms. The control condition is written and verbal general depression~     education and advice. Hypothesis: the office-based experimental intervention of written and~     verbal parent-specific depression and emotional health education and motivational advice~     increases intention to seek follow-up services for emotional health or depression, when~     compared to written and verbal general depression education and advice.~   "
122395|NCT01453777|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with diffuse~          brain lesions and clinical outcomes.~   "
122396|NCT01453764|"~     The intent of this clinical study is to answer the questions:~        1. Is the proposed treatment safe~        2. Is treatment effective in improving the disease pathology of patients with Multiple~          Sclerosis and clinical outcomes?~   "
122397|NCT01453751|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Type II Diabetes Mellitus.~   "
122398|NCT01453738|"~     This trial is planed to study if allogeneic mesenchymal stem cells would be safe and~     beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of~     stem cells will be used in this study.~   "
122399|NCT01453725|"~     This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in~     participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were~     to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline)~     and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the~     identity of the injection. In the Part 2 extension, all participants were to receive~     golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to~     Week 48. In Part 2, the participants were to be told they were receiving active study drug.~     The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks~     is superior to placebo as measured by the proportion of participants achieving an Assessment~     in Ankylosing Spondylitis (ASAS) 20 response at Week 16.~   "
122400|NCT01453712|"~     The objective of this study is to compare a standard coronary CT angiography scan protocol~     with conventional image reconstruction with a scan protocol using reduced tube current and a~     new image reconstruction algorithm. The investigators hypothesize that the image quality of~     the new scan protocol is not inferior, while radiation dose estimates are reduced by around~     30%.~      Secondary endpoints of the study include quantitative image quality parameters, prevalence~     of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics~     (calcified, non-calcified, mixed) and prevalence of follow-up examinations.~   "
122401|NCT01453699|"~     The purpose of this study is to examine how the death of a parent as a child, adolescent or~     young adult affects health and psychosocial wellbeing in adult life and to evaluate the~     impact in adult life of counseling to children, adolescents and young adults who lost a~     parent.~   "
122402|NCT01453686|"~     The use of topical steroids in the treatment of alopecia areata in children is common~     practice. However, no particular potency of steroid is accepted as the standard treatment~     due to the paucity of high quality evidence in the dermatology literature to substantiate~     their use. Two randomized controlled trials exist assessing topical steroid efficacy in this~     disorder, both have methodological limitations. The question remains as to which topical~     steroid is safe and efficacious for use. We performed a double blinded controlled trial to~     assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared~     with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.~   "
122403|NCT01452711|"~     The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD),~     compared to lansoprazole in patients with gastric ulcer.~   "
122404|NCT01452698|"~     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared~     to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA~     classification grading system.~   "
122405|NCT01452685|"~     The purpose of this study is to compare the long term safety and efficacy of TAK-385, once~     daily (QD) following continued administration in participants who completed a Phase II~     dose-finding study.~   "
122406|NCT01453673|"~     This study is a retrospective review of chart. Clinical results including range of motion,~     muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and~     meniscus will be re-evaluated for clinical application.~   "
122407|NCT01453660|"~     Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers,~     including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are~     side effects. One of the possible long-term side effects of cisplatin is thought to be heart~     disease. The way that cisplatin causes heart disease is not well understood. One possibility~     is that cisplatin may damage the inside layer of blood vessels called the endothelium. The~     purpose of this study is to measure changes in the endothelium that happen when patients~     with GCT get cisplatin chemotherapy and to compare these changes with a group of patients~     not receiving chemotherapy.~   "
122408|NCT01453647|"~     This project will be the first known to explore the relationships among immunity and stress~     and the symptoms of fatigue, pain, and mood following guided imagery in women with~     fibromyalgia. Finding ways to reduce these unpleasant symptoms may lead to improved function~     and well-being in this chronic disorder.~   "
122409|NCT01453634|"~     Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol~     Injection.~   "
122432|NCT01453335|"~     VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter~     access targets perceived by clinicians with experience in intravenous cannulation when~     compared to the number of access targets that these clinicians are able to visualize unaided~     or to palpate.~   "
122738|NCT01449292|"~     The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System~     treatment plus optimal medical therapy compared in patients with advanced upper lobe~     predominant (ULP) heterogeneous emphysema.~   "
122410|NCT01453621|"~     Blunt head trauma (BHT) accounts for >450,000 emergency department (ED) visits for children~     annually in the US. Fortunately, >95% of head trauma in children is minor in nature.~     Although most children have minor head trauma, clinicians obtain cranial CTs in 35-50% of~     these children, which carries a radiation risk of malignancy. Recently, the investigators~     conducted a study of 44,000 children in the Pediatric Emergency Care Applied Research~     Network (PECARN) in which the investigators developed and validated clinical prediction~     rules that identify which children with minor BHT are at very low risk of having~     clinically-important traumatic brain injuries (TBI) and, therefore, do not require a CT~     scan. In this proposal, the investigators aim to assess whether implementing the PECARN TBI~     prediction rules (one for preverbal, one for verbal children) via computerized clinical~     decision support (CDS) decreases the number of (unnecessary) cranial CT scans obtained by ED~     physicians for children with minor BHT at very low risk of clinically-important TBIs. After~     a two-site pilot phase to test and refine the CDS, the investigators will conduct a~     seven-center prospective trial. The investigators will measure cranial CT use prior to and~     after the intervention implementation of CDS and clinician education. The investigators will~     study the use of CT by practitioners for children <18 years for 12 months pre- and~     post-intervention.~   "
122411|NCT01453608|"~     The purpose of this study is to determine, relative to placebo, the effect of iron repletion~     therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with~     chronic heart failure and iron deficiency.~   "
122412|NCT01453595|"~     This study tests a new medication for treatment of kidney cancer, called BEZ235. This~     medication works by blocking several mechanisms that the cancer needs to grow and survive.~     By blocking these mechanisms, the medication can thus suppress further growth of the cancer,~     possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus [Torisel®]~     or everolimus [Afinitor®]) typically only block one mechanism in cancer cells, so the~     investigators think that BEZ235 may work even better against kidney cancer.~      The purpose of the first part of this study is to test the safety of giving BEZ235 at~     different doses. The investigators are trying to find a safe dose of BEZ235 and want to find~     out what effects, good and/or bad, it has on the patient and the cancer.~   "
122413|NCT01453582|"~     The purpose of this study is to confirm the efficacy and safety of total flavonoids of~     propolis dropping pill to treat angina pectoris, evaluated by total exercise time of~     treadmill exercise test.~   "
122414|NCT01453569|"~     The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule~     is effective and safe in the treatment of mild to moderate alzheimer' disease, and to~     determine the best therapeutic dose of sodium oligo-mannurarate capsule.~   "
122415|NCT01453556|"~     Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in~     laparoscopic right colectomy reduces post-operative bowel canalisation time and length of~     stay in comparison with extracorporeal mechanical anastomosis.~   "
122416|NCT01453543|"~     Background: There is a hypothesis in literature that the mechanical action of deep~     transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as~     yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles~     tendon. Objective: The purpose of the present study was to investigate whether one session~     of DTF can influence the Achilles tendon blood flow.~      Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy~     participants volunteered. Each person underwent the following four steps of the procedure:~     1. Measuring the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon,~     3. Measuring of the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of~     rest (POST20).~      Intervention: one leg of each person was randomly assigned to deep transverse friction~     session, the other leg was used as a control leg. Friction was applied continuously for a~     total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue~     depths at the distal and the proximal midportion of the Achilles tendon. For each level, the~     capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling~     pressure was registered.~   "
122417|NCT01453530|"~     Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents,~     normalization of physiological function, observation for medical or surgical complications,~     treatment of immediate side effects of anesthesia and surgery and, ultimately, discharge and~     return home. Street fitness implies that the patient is not only ready to go home, but is~     also capable of safely taking part in the traffic. A full recovery of cognitive functions is~     part of this stage. Neuromuscular blocking agents (NMBAs) are commonly used during surgery~     to facilitate endotracheal intubation, allow assisted or controlled ventilation, and let~     surgery proceed easily. Sugammadex is approved in Europe for routine clinical use to reverse~     neuromuscular blockade induced by steroidal non-depolarizing muscle relaxants. Several~     anesthesiologists from all over the world, have independently reported that patients seem to~     be more alert in the early phase of recovery after reversal of NMB with sugammadex compared~     to reversal with a cholinesterase inhibitor or spontaneous recovery. However, these~     observations have not been substantiated in a clinical study.~      Objective: The main aim of the present study is to assess whether sugammadex has a positive~     effect on the post-operative alertness of the patients, to assess the nature, magnitude and~     the time of onset of this effect and if a clinically relevant effect has been observed to~     enable the sample size calculation for a formal well-powered efficacy study.~      Study design: Randomized, controlled observer-blind single centre phase IV study. Upon After~     stratification for type of surgery and age patients will be randomized to receive sugammadex~     (arm A), neostigmine/glycopyrrolate (Arm B) or no reversal agent (arm C).~      Study population: A total of 30 evaluable subjects, aged 18-65 years, with a medical need~     for general anesthesia and neuromuscular blockade, will be included in the study.~      Intervention: Anesthesia will be standardized according to the usual protocol. At the end of~     the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine receptors are still~     blocked by rocuronium, patients will receive either sugammadex, neostigmine plus~     glycopyrrolate, or no reversal agent.~      Main study parameters: At 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been~     reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists~     will be carried out in a subsequent order to assess recovery and psychomotor function:~     Modified Aldrete Score, the trail making test, the Maddox wing test, and visual analogue~     scales from both observer and patient.~   "
122418|NCT01453517|"~     The study is designed to test a pilot intervention for bariatric patients who are starting~     to regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an~     empirically supported therapy for Borderline Personality Disorder, has also successfully~     been applied to patients with substance use and binge eating problems. The purpose of this~     study is to develop and test a group intervention based on DBT and cognitive behavioral~     therapy (CBT) techniques for patients engaging in these maladaptive behaviors after surgery~     with co-occuring weight gain.~   "
122419|NCT01453504|"~     The purpose of this trial is~        1. to determine the recommended dose of everolimus for a subsequent Phase II trial~        2. to determine the efficacy of everolimus plus DHAP~   "
122420|NCT01453491|"~     The purpose of this research study is to:~        -  1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects~          with ulcerative colitis~        -  2) Determine the amount of SRT2104 measured from a single blood sample in addition to~          colon and/or rectal tissue samples (biopsies)~        -  3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or~          rectum when taken orally for 8 weeks~        -  4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A~          biomarker is a biological marker (or substance such as a protein) that is used as an~          indicator of changes in a biological state that corresponds to the risk or progression~          of a disease.~   "
122421|NCT01453478|"~     This is a Phase I study to assess the combined effects of food and suppression of gastric~     acid secretion on the relative bioavailability of an immediate release (IR) tablet~     formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8~     receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the~     co-administration of food enhances absorption and the inter-subject variability for the~     current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and~     secondly to assess whether two proposed bioenhanced formulations offer any improvement over~     the current GSK1325756 IR formulation under PPI conditions.~      This open-label, randomized, 5-period crossover study will be completed in a single cohort~     of subjects, with an interim analysis after completion of Treatment Period 4. During~     Treatment Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the~     fed state, GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in~     the fasted state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression~     to Treatment Period 5 and the choice of bioenhanced formulation for dosing in this treatment~     period will be dependent on the findings of an interim analysis of the pharmacokinetic~     profile and relative bioavailability of each formulation following completion of Treatment~     Periods 1 to 4. In Treatment Period 5, subjects will receive the selected GSK1325756~     bioenhanced formulation in the fed state.~   "
122422|NCT01453465|"~     RATIONALE: Studying biomarkers of tissue samples from patients with cancer in the laboratory~     may help doctors learn more about changes the occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with rhabdoid tumor~     of the kidney and atypical teratoid rhabdoid tumor.~   "
122423|NCT01453452|"~     RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer~     survivors to lose weight and improve their quality of life.~      PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in~     improving physical activity and weight loss in overweight women who are breast and~     colorectal cancer survivors.~   "
122424|NCT01453439|"~     The purpose of this study is to learn more about two different types of psychotherapy to~     help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic,~     and common disorder consisting of distressing or impairing preoccupation with perceived~     defects in one's physical appearance. Individuals with BDD have very poor psychosocial~     functioning and high rates of hospitalization and suicidality. Because BDD differs in~     important ways from other disorders, psychotherapies for other disorders are not adequate~     for BDD. Despite BDD's severity, there is no adequately tested psychosocial treatment~     (psychotherapy) of any type for this disorder. This study will compare the effectiveness of~     Cognitive Behavioral Therapy and Supportive Psychotherapy as well as predictors of~     improvement.~   "
122425|NCT01453426|"~     This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of~     two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and~     Caucasian healthy volunteers.~   "
122426|NCT01453413|"~     The purpose of this study is to determine the difference between self-reported, estimated~     blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.~   "
122427|NCT01453400|"~     This study is to evaluate the onset of relief provided by a single, oral dose of fast~     release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore~     throat pain.~   "
122428|NCT01453387|"~     The main purpose of this study is to test the experimental drug, MSC2015103B at different~     dose levels and on different treatment schedules, to see whether it is safe and can be~     tolerated when given to subjects once a day one day per week over a 21-day period or once a~     day three times per week over a 21-day period. The investigators would also like to find out~     how MSC2015103B is broken down by the body.~      Additional purposes of the trial are to assess side effects of MSC2015103B and to find out~     whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to~     explore pharmacokinetics.~   "
122429|NCT01453374|"~     This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in~     prison and continuing VIVITROL upon release into the community.~   "
122430|NCT01453361|"~     Preliminary studies with a variety of vaccines suggest target accessibility (potential~     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to~     overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a~     novel autologous vaccine to address inability to fully identify cancer associated antigens,~     antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and~     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer~     vaccines, the investigators designed a novel dual-modulatory autologous whole cell vaccine,~     Vigil™ (bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine), incorporating the rhGMCSF~     (recombinant human GMCSF) transgene and the bifunctional shRNAfurin (to block proprotein~     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer~     associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen to~     immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune~     resistance. The investigators have also completed the Phase I assessment of Vigil™ vaccine~     in 27 advanced solid tumor patients (1.0 x 10e7 or 2.5 x 10e7 cells/injection/month for a~     maximum of 12 vaccinations) who have not experienced any significant adverse effects~     following 131 vaccinations, including 4 patients with melanoma. Plasmid functionality,~     immune biomarker response, and preliminary evidence of anticancer activity have been~     observed. This is a Phase II study of intradermal autologous Vigil™ cancer vaccine (1.0 x~     10e7 cells/injection; maximum of 12 vaccinations) in patients with stages IIIc and IV~     melanoma with biopsy accessible lesions to document blood and intratumoral immune responses~     and assess correlation with survival.~   "
122434|NCT01453309|"~     The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2~     to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease~     in the number of allogenic blood transfusions when a cell saver is used intraoperatively.~     Another secondary objective is to determine incidence of complications associated with cell~     saver use and transfusions.~   "
122435|NCT01453296|"~     This study will investigate the effect of dosing paedeatric asthmatic subjects with~     GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.~   "
122436|NCT01453283|"~     Background:~        -  Trabectedin is an experimental drug that kills some cancer cells in the laboratory and~          in mice by interfering with genetic material (DNA) in cancer cells.~        -  In some adult patients with cancer who received trabectedin, tumors grew slower or~          shrank.~      Objectives:~        -  To determine a dose of trabectedin that can be given safely to children and adolescents~          as a 24-hour continuous infusion through a vein.~        -  To determine the side effects of trabectedin in children and adolescents.~        -  To study how the body handles trabectedin by measuring the amount of the drug in the~          bloodstream over time after a dose is given.~        -  To measure the effect of trabectedin on DNA in white blood cells.~        -  To determine if an individual's tumor cells have a specific proteins involved in DNA~          repair and if a pattern of genes can be identified in tumor samples that might help~          explain why trabectedin reduces tumors in some individuals and not others.~        -  To study genetic factors that may influence the way the body handles trabectedin.~        -  To see if trabectedin is beneficial in certain types of cancer.~      Eligibility:~      -Children between 4 year and 17 years of age with tumors that recur or no longer respond to~     standard treatment.~      Design:~        -  Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days.~          The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent~          groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as~          the preceding dose is well tolerated. Patients enrolled at the lowest dose level may~          have their dose increased to the next level if they tolerated the lower dose well.~          Treatment may continue as long as the cancer does not worsen and the treatment is~          tolerated.~        -  Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to~          study how the body handles trabectedin.~        -  A tumor sample obtained from a prior surgery or biopsy is examined for proteins~          involved in DNA repair.~        -  A blood sample is drawn to look for genetic factors that may influence how the body~          handles trabectedin.~        -  Patients have periodic physical examinations and blood tests. MRI or CT scans are done~          before starting therapy and after every two treatment cycles to evaluate the tumor.~   "
122437|NCT01453270|"~     The purpose of this study is to determine whether the use of a 3-hour protocol utilizing~     non-invasive hemodynamic optimization treatment strategy results in better outcome and lower~     hospital costs in patients who present with severe bloodstream infections to the Emergency~     Department (ED).~   "
122438|NCT01453257|"~     Treatment options for patients with colorectal cancer (CRC) have increased in the last~     years. However, there are no validated prospective molecular markers in CRC to select which~     agents are better to treat any individual case. The conventional first-line treatment in CRC~     patients in clinical studies get a proportion of patients free of progression at 12 months~     ranging from 35-40% with a median of 9 months of free disease progression.~      The aim of this study is to demonstrate that the identification of therapeutic targets in~     real time and their prospectively use to customize the treatment get a proportion of~     colorectal metastatic patients patients free of progression disease at 12 months of 50%.~   "
122439|NCT01453244|"~     The aim of this study is to investigate the relationships between drug response and the host~     genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV).~     And thus, the investigators are trying to develop the pharmacogenomic guideline in the~     Korean patients with HCV.~   "
122440|NCT01453231|"~     Obesity is a chronic disease now considered a major public health concern in the global~     context, as it causes or exacerbates many diseases limitations in providing quality of life~     and higher treatment costs. The increase in the number of patients undergoing bariatric~     surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the~     search for growth by plastic surgery. Currently several techniques of thighplasty has been~     submitted but no studies were found that evaluated the characteristic clinical and emotional~     resulting from this procedure. This study has as a goal to evaluate the body image and~     quality of life in women submitted to thighplasty.~   "
122441|NCT01453218|"~     Renal dysfunction in the context of liver transplantation is a major issue, with difficult~     patients' management and determining a worsened prognosis.~      Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes,~     including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or~     interstitial parenchymatous insufficiency. On top, intra- or post-transplant events,~     including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this~     situation.~      At present MELD criteria favours allocation of organs to patients suffering from renal~     insufficiency, so at least 30% of the investigators liver transplant patients suffer from~     some degree of renal impairment pretransplant.~      After liver transplant impaired renal function tends to recover partially or completely,~     unless advanced parenchymatous lesions are significantly involved as a major cause of renal~     dysfunction.~      In this context, calcineurin inhibitors avoiding or sparing protocols may help in the~     recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25~     antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the~     use of these antibodies to a reduced cohort of liver transplant patients.~      Polyclonal antibodies might provide an advantage in management of liver transplant patients~     with renal insufficiency, without increasing acute rejection episodes of the allograft~     efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use~     of ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.~      The aim of this study is to evaluate the efficacy and security use of immunosuppression~     based on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.~   "
122442|NCT01453205|"~     The overall purpose of the study is to determine if MEDI-551, when used in combination with~     salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine~     (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem~     Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.~   "
122443|NCT01453192|"~     The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months~     after transplantation in HIV-infected patients under three antiretroviral drugs regimen~     including Raltegravir.~   "
122444|NCT01453179|"~     This clinical trial serves the purpose to compare the long-term effects of a treatment of~     actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3%~     gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the~     healing effect of these two medications on the skin lesions (i.e. the damaged skin parts)~     can be maintained for a prolonged period.~   "
122445|NCT01453166|"~     The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective~     diet plan to reduce cardiovascular risk factors of new cardiovascular events.~   "
122446|NCT01453153|"~     Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and~     tolerability study to determine the safe dose of PEGPH20 to use in combination with~     gemcitabine in Stage IV previously untreated pancreatic cancer patients.~      Phase 2: Randomized, double blind study to compare the effect of overall survival of~     gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated~     pancreatic cancer patients.~   "
122447|NCT01453140|"~     In this study the investigators are proposing to treat patients with steroid-refractory~     Graft-versus-host Disease (GVHD) in a manner designed to promote CD4+CD25+FoxP3+ Tregs. The~     profound immune suppression which follows the most common salvage treatment for GVHD have~     unfortunately lead to very poor outcomes because of high infection rates. A more targeted~     approach based on the promotion and stabilization of Tregs is hoped to allow GVHD control~     without the profound immunosuppression usually seen. High-dose cyclophosphamide and~     sirolimus have been successfully used for the prevention of GVHD and have shown to enhance~     the Tregs subpopulation. The addition of low dose IL-2 and a demethylating agent such as~     azacitidine will also be studied in an attempt to promote and stabilize the FoxP3 expression~     of Tregs.~   "
122448|NCT01453127|"~     The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD),~     mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB),~     Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test~     several hypotheses - some confirmatory, and some novel. Such use will provide new data on~     the potential clinical and research utility of DaTscan in neurodegenerative diseases. The~     findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging~     studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of~     neurodegenerative diseases.~   "
122449|NCT01453114|"~     The overarching goal of this study is to adapt a cognitive behavioral prevention of~     recurrence treatment (CBT-PR) for women with a history of recurrent major depressive~     disorder who decide to discontinue their maintenance anti-depressant (AD) treatment for~     pregnancy.~   "
122450|NCT01453101|"~     The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and~     bortezomib improves the progression free survival and the response rate compared to~     historical controls of fludarabine and melphalan alone.~   "
122451|NCT01453088|"~     In this study the investigators are comparing this standard regimen to the newly established~     regimen of melphalan and bortezomib.~   "
122452|NCT01453075|"~     The purpose of this study is to study the effects of valacyclovir on patients who have~     hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which~     causes genital herpes. Some persons with genital herpes have sores in their private areas~     but most persons do not have any symptoms at all. Valacyclovir is a medication which is~     commonly used to treat or prevent outbreaks of genital herpes. This medication is already~     approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not~     been approved to treat chronic hepatitis C.~      The study will take 16 weeks. Participants will be assigned to take either the study drug,~     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the~     persons participating will not know which medication they are receiving. Study visits will~     occur every two weeks and will take approximately 3-45 minutes. All study visits will occur~     at the G.V. Sonny Montgomery VA Medical Center.~   "
122453|NCT01453062|"~     B-cell chronic lymphocytic leukemia (CLL) is a subtype of mature peripheral B-cell~     neoplasms, characterized by the accumulation of circulating malignant lymphocytes that~     typically express cell surface markers CD5, CD20, and CD23. It is the most common type of~     leukemia in adults in Western Europe and in the US. The median age at diagnosis is 65-70~     years, with a male to female ratio of 2:1. Initially, most patients present with~     asymptomatic lymphocytosis and do not need cytoreductive therapy. Patients with active~     disease are characterized by a lymphocyte doubling time of less than 6 months, or~     progressive, even massive lymphadenopathy, hepatosplenomegaly, anemia and thrombocytopenia.~     Constitutional symptoms such as fever, night sweats, unintended weight loss, and extreme~     fatigue are common in advanced disease and can significantly impact quality of life. CLL~     also causes relative immunosuppression that increases the risk of infections that are~     ultimately the major cause of death in this patient population. Median survival at diagnosis~     ranges from 5 to 20+ years depending on risk factors, but is only 6 to 14 months for~     patients with CLL refractory to available therapies.~      Arzerra (ofatumumab) is a human monoclonal antibody (IgG1) that binds specifically to a~     distinct epitope encompassing both the small and large extracellular loops of the CD20~     molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes~     from the pre-B to mature B lymphocyte stage and on B-cell tumors.~      Arzerra is designated as an orphan medicinal product in the European Union (EU) for~     treatment of chronic lymphocytic leukemia. The Committee for Orphan Medicinal Products~     (COMP) concluded that chronic lymphocytic leukemia was estimated to be affecting~     approximately 3.5 in 10,000 persons in the Community at the time the application was made~     (June 2008) and that the condition is chronically debilitating and life-threatening, in~     particular due to poor long-term survival in high-risk patients.~      Arzerra was given a conditional approval in the EU on April 19, 2010. The approved~     indication in the EU for the product is treatment of CLL in patients refractory to~     fludarabine and alemtuzumab. A specific obligation for this conditional approval was an~     agreement by GSK to conduct a post-marketing observational study in CLL patients receiving~     Arzerra. The data from this study is intended to enhance the evidence of the safety and~     efficacy of Arzerra as it is used in clinical practice, and once final data are available,~     together with results of a second specific obligation study, will support the transition~     from conditional to a full approval of Arzerra in the EU.~      The objective of this observational study is to provide additional data to confirm the~     safety profile and efficacy of Arzerra for CLL patients treated in clinical practice.~      Particular data of interest are: co-morbidities (specific chronic disease diagnoses),~     concomitant medications, disease (CLL) characteristics, prior treatment regimens, adverse~     events, reasons for discontinuation of Arzerra therapy, Arzerra response, progression free~     survival, and overall survival.~      This is an observational, non-interventional, medical record review study in CLL patients. A~     total of 100 patients with CLL who have previously received Arzerra, whether alive or~     deceased, and have either completed the full course of Arzerra therapy or discontinued~     treatment early will be eligible to participate in the study. Centers across Europe who are~     members and non members of the European Research Initiative of CLL (ERIC) and treat CLL~     patients will participate in the study.~      CLL patients newly initiating Arzerra who are still undergoing the treatment phase and~     patients having been treated with Arzerra in phase II or phase III clinical trials will be~     excluded.~      For patients who have completed approximately 1 year or more of follow up since Arzerra~     initiation, data on response to Arzerra, adverse events during treatment and subsequent to~     treatment, patient status, progression free survival and overall survival covering the~     period up to approximately one-year post-drug initiation will be collected. For patients who~     have not completed approximately l year of follow-up since Arzerra initiation, including~     those who have been lost to follow up or died prior to one year or have not yet had a full~     year to elapse in calendar time, similar data will be collected at the point in time at the~     last available patient contact with the physician using information in the record. After~     approach for informed consent from the patient or next of kin for patients who have died to~     review the medical record, no interaction with the patient will occur.~   "
122454|NCT01453049|"~     The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose~     combination tablet will safely and effectively control glycemia as first-line oral therapy~     in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of~     treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary~     objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in~     lowering Glycosylated Hemoglobin (HbA1c).~   "
122455|NCT01453036|"~     1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin~          is one of the main causes of failure of eradication. 23S rRNA point mutation of~          Helicobacter pylori is associated clarithromycin resistance~        2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment~          regimens containing a proton pump inhibitor and combination of two antibiotics~          (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate~          Helicoabacter pylori more successfully~        3. Material & methods The investigators enroll patients diagnosed with peptic ulcer,~          endoscopically. Helicobacter pylori is documented with Urea breath test or silver~          staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S~          rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation,~          the investigators consider as resistance to clarithromycin and choose the treatment~          regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no~          mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin,~          clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare~          eradication rate with conventional treatment,proton pump inhibitor, amoxicillin,~          clarithromycin.~   "
122456|NCT01453023|"~     This study will investigate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the~     novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.~   "
122466|NCT01452893|"~     Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction.~     Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more~     frequently report hypoglycemia, particularly after strenuous activities. The study~     investigates the counter regulatory hormonal response to physical stress and the impact on~     cognitive function in subjects with and without Addison's disease, type I diabetes and~     healthy subjects.~   "
122467|NCT01452880|"~     The purpose of this study is to compare the analgesic efficacy and side effects induced by~     administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus~     0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment~     to face extracorporeal shock wave lithotripsy.~   "
122468|NCT01452867|"~     Inexperienced rescuers may encounter severe problems in an unconscious patient in opening~     and maintaining an upper airway patent. Gaining evidence which ventilation technique may be~     most efficient and safe is of utmost importance to potentially improve outcome during~     cardiopulmonary resuscitation.~   "
122457|NCT01453010|"~     Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors~     and causes huge loss of function and independence. A wide range of treatment approaches have~     been developed to improve motor recovery. Despite treatments, such as Constraint Induced~     Movement Therapy, showing promise, these in large have been have focused on high-intensity~     and repetitive task-specific practice. Patients with little hand or finger movements however~     may not be able to participate actively in task specific training.~      The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening~     of the fingers and hand. This allows the patient to grasp and release objects repeatedly,~     hence enabling participation in repetitive task practice and increasing potential for motor~     recovery. Despite the SaeboFlex being used successfully in several centers in the country~     and internationally, research to provide evidence of effectiveness is scarce. As a~     consequence funding for the SaeboFlex is limited and usually requires patients' to fund~     their own.~      The study aims to explore the potential benefits and feasibility of participating in a~     Self-directed SaeboFlex training program to allow repetitive task practice in patients early~     after stroke.~      Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute~     sessions a day. Activities focus on grasping and releasing balls and reaching for targets,~     wearing the SaeboFlex for the majority of the session. At the end of each session the~     SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects~     will be set individualized training program by a Saebo-trained therapist. The program will~     be graded and progressed at a rate that is appropriate to each individual.~      The study will measure and follow-up 8 subjects to explore improvements in recovery and~     functional ability of the upper limb and affect on dependency levels. It will also explore~     the level of intensity patients early after stroke can tolerate and how they participate in~     self-directed therapy. All patients will meet the inclusion criteria and be motivated to~     undergo the specific SaeboFlex self-directed training program. Subjects will record the time~     and intensity of their training sessions and also their routine upper limb therapy. Patients~     will be assessed before, during and after the 3 months training. If these cases show promise~     the study will support the need for large trials including clinical efficacy and dose~     finding studies.~   "
122458|NCT01452997|"~     The purpose of this study is to evaluate two separate antiinflammatory products for the~     relief of symptoms through suppression of the immunological and inflammatory response~     following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI~     formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate~     physical matched placebo products.~   "
122459|NCT01452984|"~     Mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving~     maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and~     functional cervifacial region. Yet, treatment can result in changes to function and~     appearance with effects on quality of life. This project uses Grounded Theory to explore the~     Mohs surgery experience of NMSC patients who have head and neck lesions through interview~     and observation of the surgical appointment.~   "
122460|NCT01452971|"~     Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as~     the major risk factors for lung cancer development. In this proposal, the investigators~     collected fifteen kinds of major PAHs and the investigators would like to perform the~     following studies:~        1. Study the gene expression and subcellular localization of GNMT in the normal-tumor~          tissue pairs of lung cancer patients.~        2. Study the associations of the polymorphisms of GNMT in lung cancer patients and the~          susceptibility to lung cancer;~        3. To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the~          normal-tumor tissue pairs of lung cancer patients.~        4. Study the associations of the copy number variation (CNV) of GNMT and the~          susceptibility to lung cancer;~        5. Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung~          cancer cell lines.~   "
122461|NCT01452958|"~     Main objective :~      The purpose of this study is to prove that the effects of bacterial endotoxin and cytokine~     TNF-α, on protein loss, fatty acid release, and glucose metabolism depend on two mechanisms:~        1. Direct local effects in muscle tissue.~        2. Activation of the hypothalamo-pituitary axis and a stress-hormone response~      Study protocols:~        1. Acute metabolic effects of TNF-α(Beromun, Boehringer-Ingelheim Germany) vs placebo~          perfused into the femoral artery of the leg in 8 healthy subjects.~        2. Acute metabolic effects of~             -  placebo(saline)~             -  endotoxin(US standard reference E.Coli, endotoxin)~             -  TNF-α(Beromun, Boehringer-Ingelheim Germany) given systemically~             -  in 8 patients with hypopituitarism(to block stress hormone release) and in 8~               healthy subjects all studied thrice.~   "
122462|NCT01452945|"~     Young children presenting to the Emergency Department (ED) with wheezing often have~     prolonged stays in the ED or even get admitted to the hospital. This is a prospective~     observational study in which the investigators will use bedside 2D ultrasound to evaluate~     the lung ultrasound findings in children less than 24 months presenting to the ED with~     wheezing.~      The investigators hypothesize that children less than 24 months presenting to the Emergency~     Department with wheezing will have a range of lung ultrasound findings that will include~     normal findings, B lines, subpleural consolidations, and pleural effusions. The~     investigators also hypothesize that the findings will be reproducible between two equally~     trained providers.~      The investigators also hypothesize that lung ultrasound findings patients 0-24 months~     presenting to the ED with wheezing will correlate with specific clinical outcomes. An~     exploratory analysis will be performed to look for correlations between lung US findings and~     acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy,~     response to treatment and radiologic or viral studies if performed.~   "
122463|NCT01452932|"~     Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and~     aerobic capacity in patients over 50 with COPD, in a health care institution provider in~     Antioquia.~      Question: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic~     capacity in COPD patients over 50 years, in a health service institution provider in the~     department of Antioquia?~      Hypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity,~     other than the breathing exercises and relaxation~      Design: Randomized clinical trial with allocation and blinding of the autcomes assesor.~      Participants: COPD patients stage II and II, male and female, over 50 years old, who are~     attending to a community health service provider in the department of Antioquia.~      Intervention: A physiotherapeutic intervention using PNF technique was applied to the~     experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve~     weeks protocol performing three sessions per week.~      Outcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and~     the six minute walking test respectively at the begining and the end of the study.~   "
122464|NCT01452919|"~     The purpose of this study is to determine whether or not people with schizophrenia who take~     LY2140023 become physically dependent on it, and experience a series of symptoms such as~     craving to have the drug when they stop using it.~      This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a~     double-blind phase consisting of up to 3 weeks.~   "
122465|NCT01452906|"~     The purpose of this study is to determine if Omeprazole is affected by PA21.~   "
122469|NCT01452854|"~     The purpose of this study is to look at how a chemotherapy treatment (Temozolomide, also~     called Temodar) affects the process of ovarian aging which is measured by a decline in~     ovarian follicle count, in patients with Low Grade Glioma (LGG). It is important to know if~     different patient factors and Temozolomide influence the rate of ovarian aging in women with~     LGG who have good long-term survival rates. This will allow better counseling about the~     effects of this particular chemotherapy agent on fertility in women.~   "
122470|NCT01452841|"~     Folklore has suggested that consuming grapefruit may promote weight control. Sparse data~     exist to support this hypothesis, though there is some evidence of health promotional~     effects regarding blood pressure and lipid profiles. The aims of this randomized controlled~     trial are to determine the role of grapefruit in:~        1. Reducing weight~        2. Reducing blood pressure~        3. Reducing inflammation~        4. Improving the lipid profile.~      The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce~     weight, blood pressure, and inflammation while improving the lipid profile in overweight,~     healthy adults.~   "
122471|NCT01452828|"~     The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of~     TR701 FA in subjects with advance renal impairment.~   "
122472|NCT01452815|"~     The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg~     and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but~     contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with~     symptoms associated with gastroparesis.~   "
122473|NCT01452802|"~     The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II~     (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class~     IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and~     who meet the FDA approved indications for HM II LVAD destination therapy.~   "
122474|NCT01452789|"~     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after~     utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was~     associated with a ~30% reduction length of treatment compared to standard of care morphine.~     Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is~     needed to unequivocally establish the superiority of buprenorphine over morphine. The~     primary objective of the trial is to compare length of treatment using sublingual~     buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.~   "
122475|NCT01452776|"~     The purpose of this study is to determine the safety of long term use of TAK-438, once daily~     (QD), for the maintenance treatment of healed erosive esophagitis.~   "
122476|NCT01452763|"~     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared~     to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who~     require long-term therapy of low-dose aspirin.~   "
122477|NCT01452750|"~     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared~     to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who~     require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).~   "
122478|NCT01452737|"~     The investigators wish to compare the efficacy and patient tolerability of a preparation~     consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard~     preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg~     bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.~   "
122479|NCT01452724|"~     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared~     to lansoprazole in patients with duodenal ulcer.~   "
122480|NCT01452672|"~     This study compares two different field set-ups in patients with breast cancer following a~     breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the~     chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.~      Patients in both treatment arms will receive radiotherapy with a shortened fractionation~     schedule.~      Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the~     chest-wall and supraclavicular fossa in terms of loco-regional control, survival and~     treatment toxicity.~   "
122481|NCT01452659|"~     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily~     (QD), for 12 weeks in women with uterine fibroids.~   "
122482|NCT01452646|"~     The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease~     directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive~     results in terms of overall survival at 24 months.~   "
122483|NCT01452633|"~     This study will help to answer the question, Does injecting local anesthetic before~     laparoscopic instrument ports are placed decrease pain after surgery? Patients~     participating will be randomly assigned to receive local anesthetic or saline injection at~     the site of a laparoscopic instrument port as part of their planned surgery. After surgery~     at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.~   "
122484|NCT01452620|"~     Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by~     Interventional Cardiologists~   "
122485|NCT01452607|"~     A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in~     healthy adults.~   "
122486|NCT01452594|"~     The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to~     be effective in treating certain kinds of cancer. This study hopes to improve our~     understanding of how this drug helps create an effective immune response.~   "
122487|NCT01452581|"~     The purpose of this study is to evaluate the effects of transfusion of red blood cells in~     treating postoperative dizziness in patients with moderate postoperative anemia after total~     hip arthroplasty.~   "
122488|NCT01452568|"~     The optimal medical strategy for prevention of thromboembolic events after bioprosthetic~     aorta valve replacement (BAVR) remains controversial.~      The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against~     aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or~     without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate~     thromboembolic complications, bleeding complications and death.~   "
122755|NCT01449071|"~     The primary objective of the study is to evaluate the safety, tolerability and~     Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general~     SLE as add on to standard of care treatment during the trial.~   "
122490|NCT01452542|"~     The primary objective of this pilot study is to determine the within-subject pharmacokinetic~     (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat~     administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed~     commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to~     plan and support the design of a subsequent bioequivalence study.~   "
122491|NCT01452529|"~     The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD~     tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe~     chronic low back pain uncontrolled by their current stable analgesic regimen~   "
122492|NCT01452516|"~     Spine fusion is one of the most common procedures performed in spinal surgery. Several~     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion~     (PLF) is the most widely used. However, complications can develop when the bone graft~     material used is insufficient to achieve the desired fusion. With its unique properties,~     nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to~     obtain new bone growth during the healing process.~      It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with~     CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less~     than 5 degrees of angular motion. In addition, patients are expected to see an improvement~     in Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the~     use of pain medication, returning to work, and finding satisfaction in the results of their~     surgery.~   "
122493|NCT01452503|"~     Evaluation of preference for three female condoms (FC).~   "
122494|NCT01452490|"~     The purpose of this study is to evaluate the V-Raser diode laser system with investigational~     Nail Fungus Handpiece in the treatment of onychomycosis.~   "
122495|NCT01452477|"~     Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese~     medicine, this herb has been widely prescribed for several pathologies, including diabetes,~     acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of~     cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of~     key molecules during both insulin signaling and androgen synthesis.The purpose of this study~     is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary~     Syndrome (PCOS) symptomatology.~   "
122496|NCT01452464|"~     The purpose of this US FDA post-marketing commitment study is to evaluate the safety of~     MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance~     Organization who received MenACWY-CRM vaccination as part of their routine clinical care.~     The pre-specified 26 events of interest are events commonly evaluated in vaccine safety~     studies and include certain neurological, immunological, vascular, musculoskeletal and~     hematologic disorders. All events are collected retrospectively.~   "
122497|NCT01452451|"~     The purpose of this study is to investigate the safety and tolerability of repeated doses of~     HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on~     stable metformin monotherapy.~   "
122498|NCT01452438|"~     The purpose of this study is to summarize the occurrence of incident serious medically~     attended events and events of interest up to 1 year following MenACWY-CRM vaccination~     administered as part of routine clinical care. This US FDA post-marketing commitment study~     is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM~     vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance~     Organization. The 26 events of interest are events commonly evaluated in vaccine safety~     studies and include certain neurological, immunological, vascular, musculoskeletal and~     hematologic disorders. All events are collected retrospectively.~   "
122499|NCT01452425|"~     Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular~     compartment pressures, and is a rare but serious postoperative complication.~      The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and~     non-invasively.~      The objective is to develop a model mimicking the physiopathology of MCS to assess the~     interest of the INVOS in this case.~   "
122500|NCT01452412|"~     Kidney disease is a common medical condition. Individuals with kidney disease develop a~     build-up of acid in their blood. This acid can affect their muscles, bones, glucose~     metabolism and kidneys. The investigators will test alkali treatment, to treat acid~     build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles,~     bones, glucose metabolism and kidney.~   "
122501|NCT01452399|"~     This research study is designed to look at whether the routine use of shave margins (by~     taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of~     having positive surgical margins requiring another surgical procedure, and whether this~     affects the long-term chances of getting cancer back in your breast.~   "
122502|NCT01452386|"~     To prove the modify functional magnetic stimulation could improve constipation.~   "
122503|NCT01452373|"~     The purpose of this Phase III trial is to evaluate the efficacy of oral administration of~     dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor~     modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.~   "
122504|NCT01452360|"~     This project expects the integrated database of terminally renal ill patients combines~     clinical and files of Health Insurance and renal medical society database. It will provide~     valuable actual evidence data to quality monitoring of dialysis treatment and related~     academic research. Besides, using the cohort study of chronic renal disease --「epidemiologic~     research of chronic renal disease」, we can trace the patient continually and analysis~     different risk factors of chronic renal disease in Taiwan. Taken together, the results of~     this project --1.1「Integrate the current database of renal disease and establishment of~     national monitor system」and 1.2「Epidemiologic study in chronic renal disease」-- will provide~     the basic rules of prevention and treatment, basic research and clinic application in~     chronic renal disease.~   "
122505|NCT01452347|"~     To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical~     heart valve.~   "
122506|NCT01452334|"~     The purpose of this study is to determine the side effects of treatment with the monoclonal~     antibody anti-PD-L1 (BMS-936559) in subjects with compromised bone marrow function and the~     dose that should be recommended for use in future studies.~   "
122507|NCT01452321|"~     Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a~     strategic aid in the treatment of postpartum depression.~      However, up to current days there have been no studies evaluating the effects of rTMS on~     neurocognitive and social performance of women suffering from the disorder.~      The present study evaluates the impacts of rTMS in clinical, cognitive and social~     performance.~   "
122508|NCT01452308|"~     This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients~     with fibrosis of the liver.~      Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of~     10 participants who will receive simtuzumab every other week for a total of 3 infusions.~     Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a~     total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen~     in Cohort 1.~      Participants from both cohorts who have completed the main study will be allowed to continue~     on simtuzumab treatment for an additional extension period, and will receive up to 13~     additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.~   "
122509|NCT01452295|"~     VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five~     years after their completion of study participation in protocol VTI-206 (NCT00973817) to~     gather information relating to the incidence of liver transplant, the incidence and type of~     cancer (if any), and survival.~   "
122510|NCT01452282|"~     Introduction: Patients undergoing noncardiac surgery are at increased risk of cardiovascular~     complications. The development of methods that can accurately predict the occurrence of~     these events is of critical importance and large studies have been published with this~     purpose. Based on these studies, several algorithms have been proposed to predict of~     cardiovascular events postoperatively. However, quantification of this risk is often~     difficult to measure, especially in those patients with subclinical disease, not always~     detected in routine evaluation. The ankle brachial index (ABI) has proved a valuable tool in~     the quantification of cardiovascular risk, and perhaps the most promising when compared with~     other methods. It is easy, cheap, fast and feasible in office care, with a great acceptance~     between patients and small intra and inter observer variability. Despite strong evidence of~     the utility of ABI as a tool in assessing cardiovascular risk, there are no data about the~     use of ABI in other patients referred for non vascular surgery, which constitutes the~     majority of operations performed worldwide.~      Objectives: To evaluate the use of ABI as a predictor of cardiovascular events in patients~     undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the~     reclassification of patient risk groups established by guidelines for perioperative~     evaluation.~      Methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will~     be included. Data about risk factors, signs and symptoms, physical examination and treatment~     used will be collected before surgery. The ABI will be measured and the patient will be~     monitored for 30 days to the detection of cardiovascular events: death from any~     cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation~     of troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure,~     pulmonary edema, stroke and lower limb ischemia. Postoperative electrocardiogram, total~     creatine kinase, MB fraction and troponin I will be measured daily until 3º day and whenever~     clinically indicated.~   "
122511|NCT01452269|"~     The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based,~     comprehensive program to change obesity-related health behaviors in Deaf people who use~     American Sign Language (ASL) as their primary language.~      Participants will be randomized to one of two study arms - immediate intervention or delayed~     intervention. In addition to the intervention activities, participants will also take part~     in five study visits over the course of two years. At these study visits, the investigators~     will administer several surveys as well as conduct biometric assessments.~      The investigators primary hypothesis is that the immediate intervention group will increase~     their levels of physical activity and reduce their caloric intake and body weight~     immediately following the intervention, compared to the delayed intervention group.~   "
122512|NCT01452256|"~     Desflurane and its effect on postoperative morbidity and mortality in patients undergoing~     thoracic surgery.~      Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a~     group of general anesthetics. Because of the hypnotic effects of these agents, attention has~     mainly focused on the central nervous system. In the last 10 years, however, numerous~     studies have reported that volatile anesthetic agents interact with membrane structures of~     the myocardium and thereby attenuate cardiac mechanical dysfunction and limit~     ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte.~     Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide~        -  Trial with medicinal product~   "
122513|NCT01452243|"~     The first objective is to determine the efficacy of calcium and vitamin D supplementation at~     doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in~     non-institutionalized elderly people.~      The second objective is to measure and compare treatment groups (calcium and vitamin D vs~     placebo) as regards muscle strength and musculoskeletal function, bone mineral density,~     calcidiol level and treatment safety.~   "
122514|NCT01452230|"~     Introduction: According to studies, a low physical capacity before surgery is linked with~     smaller weigh loss after surgery and increases risks of peri-surgical complications.~     Practice of regular physical activity in obese individuals improves their physical capacity.~     No specific recommendation on physical activity prescription is currently available for this~     reduced fitness population. This project aims to evaluate if a Pre-Surgical Physical~     Activity Training (PreSPAT) improves physical capacity, surgery effectiveness and decreases~     peri-surgical complications in morbidly obese individuals.~      Methods: This pilot project will be divided in 2 phases:~      Phase 1: Ten candidates for bariatric surgery will be included in this phase. In a~     pre-training focus group, subjects will be interviewed about their expectations and their~     availability for a PreSPAT. These results combined with those of the literature will be used~     to design the PreSPAT. To measure its effectiveness, anthropometric parameters, body~     composition, physical capacity, motivational stage, perceived benefits and barriers facing~     physical activity and quality of life will be evaluated before and after the PreSPAT.~     Subjects satisfaction with the physical activity intervention will be measured with a~     questionnaire at 6 weeks and at the end of the PreSPAT.~      Phase 2: 50 candidates for bariatric surgery will be randomized in 2 groups:~      Control group: receiving usual care from the integrated medical and surgical treatment~     obesity clinic of the Centre Hospitalier Universitaire de Sherbrooke, which includes~     individual counselling by an exercise physiologist every 6 weeks.~      Intervention group: will attend for three months before surgery sessions of supervised~     physical activity as developed during phase 1 in addition to usual care of the integrated~     medical and surgical treatment obesity clinic.~      Physical capacity, anthropometry, body composition, readiness to change, comorbidities,~     perceived benefits and barriers of physical activity, usual practice of physical activity,~     quality of life and patient satisfaction with physical activity intervention will be~     evaluated in the two groups before and after intervention and every 3 months after the~     surgery during one year. Each occurrence of peri-surgery complications, and the duration of~     surgery and hospitalization will be recorded.~      Impacts: Feasibility and effectiveness of supervised physical activity training will be~     assessed before the beginning of the randomized controlled study. Phase 2 of the project may~     generate information that will improve the management of obese candidates for bariatric~     surgery in order to ensure optimal results for their health. This project will also allow a~     better understanding of criteria leading to successful surgery and the effects of exercise~     training in morbidly obese individuals.~   "
122515|NCT01452217|"~     Alterations in pancreatic blood have been implicated in pancreatic inflammation and pain.~     Several modalities have been used to assess pancreatic blood flow although some of these~     methods are invasive, use ionising radiation or intravenous contrast media. This is the~     first study to utilise non-invasive magnetic resonance imaging to quantify flow within~     arteries supplying the pancreas and pancreatic perfusion is response to secretin~     stimulation.~   "
122516|NCT01452204|"~     In the past many authors have reported the abnormal contact between the rotator cuff and~     coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives~     of this study relate specifically to improve the symptoms and rehabilitation of shoulder~     function of the patient:~        1. Assess the effectiveness of magnet therapy in the treatment of impingement of the~          rotator cuff;~        2. Assess whether the application of magnetic therapy 3 times a week for three weeks, may~          be effective as a single treatment of impingement of the rotator cuff;~        3. Assess whether the combination of magnetic therapy with therapeutic exercises is more~          effective than magnetic therapy only;~        4. Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the~          short and long term.~        5. Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and~          20 mT in patients with shoulder impingement syndrome.~   "
122517|NCT01452191|"~     Many children have accidents, some are very serious and they are a major cause of death in~     children aged 1-4 years. Many accidents are preventable This study aims to find out the best~     way to help Children's Centres to provide home safety information about preventing fires to~     parents and carers of young children.~      36 Children's Centres in four study centres, Nottingham, Bristol, Norwich and Newcastle will~     be recruited to the study. 30 families will be recruited from each Children's Centre.~     Children's Centres serving the most deprived populations will be eligible to take part.~      Families will be eligible to take part if they have attended a participating Children's~     Centre in the previous three months, have parents who are 16 years or older, have a child~     under three years old and live within the catchment area of that Children's Centre. When 30~     families have been recruited that Centre will be allocated, at random, to one of three~     groups. Children's Centres in group one will be provided with guidance about preventing~     fire-related injuries (an Injury Prevention Briefing (IPB))and help and support to implement~     the IPB, the second group will be sent the IPB and the third group will not be provided with~     the IPB ('usual care'). Children's Centres will devise their own programmes of safety advice~     for parents based on the IPB.~      At recruitment and 12 months later, families and Children's Centres will complete~     questionnaires about fire safety practices. Children's Centres will also complete a~     paper-based tool about the implementation process at 12 months. Information about barriers~     and facilitators to implementing the IPB will be collected through interviews with~     Children's Centre staff.~      The study will run from May 2011 to March 2014.~   "
122518|NCT01452178|"~     The main purposes of this study are:~        -  to describe the prevalence of peripheral artery disease (including lower extremity~          artery disease, carotid artery disease, renal artery disease, and abdominal aortic~          disease) in patients with acute myocardial infarction in comparison to control subject~          from the general population,~        -  to evaluate the association of peripheral artery disease with glucometabolic status in~          patients with acute myocardial infarction,~        -  to assess the prevalence of type D personality in patients with acute myocardial~          infarction com pared to control subjects from the general population,~        -  to examine the prognostic value of peripheral artery disease in patients with acute~          myocardial infartion, and~        -  to evaluate the prognostic value of type D personality in patients with acute~          myocardial infarction.~   "
122519|NCT01452165|"~     The main purposes of this study are:~        -  to describe the prevalence and degree of reduced left ventricular function and~          hypertrophy in patients with peripheral arterial disease in comparison to controls from~          the general population,~        -  to evaluate factors of importance to left ventricular dysfunction and hypertrophy in~          patients with peripheral arterial disease, and~        -  to assess the impact of cardiac function and left ventricular hypertrophy on long-term~          prognosis in patients with peripheral artery disease.~   "
122520|NCT01452152|"~     It is standard treatment to take anti-platelet medication after cardiac catheterization and~     stent placement to help prevent the formation of blood clots that may cause heart attack or~     stroke. The most commonly used anti-platelet medicine is clopidogrel (Plavix®). However,~     researchers have found that people vary in their response to clopidogrel, in part because of~     differences in their genes. Prasugrel (Effient®)is another anti-platelet medication used to~     prevent clots. The genetic differences that affect clopidogrel response do not affect~     prasugrel response. Recently, the FDA added a warning to the label of clopidogrel to notify~     doctors and patients with certain genetic differences may not get the full benefit from~     clopidogrel. Despite this, genetic testing for these variations is not usually done in~     standard medical practice. The purpose of this study is to see if patients with certain gene~     differences have fewer major cardiac events after stent placement if they are given~     anti-platelet therapy guided by their individual genetic type compared to standard~     anti-platelet therapy.~   "
122521|NCT01452139|"~     The objective of the RAPID STEMI study is to evaluate the feasibility, efficacy, and safety~     of a pharmacogenetic approach to anti-platelet therapy for the treatment of ST-segment~     elevation myocardial infarction (STEMI) patients following percutaneous coronary~     intervention (PCI) using point-of-care genetic testing for the CYP2C19*2, *17, and ABCB1~     3435 C>T alleles.~   "
122522|NCT01452126|"~     This is a dose finding study to identify the minimum effective anesthetic concentration~     (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in~     supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and~     popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane~     (TAP) blocks in adults.~   "
122523|NCT01452113|"~     The purpose of this study is to compare the effect of a single administration of a DPP-IV~     inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic~     patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with~     diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize~     that the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic~     nervous system. This hypothesis will be validated if a lower glycemic response to DPP-IV~     inhibitor treatment is observed for the neuropathy group compared to control.~   "
122543|NCT01451853|"~     Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is~     the objective of this study to determine the safety and efficacy of SPI-1005 at three dose~     levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum~     chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat~     chemotherapy induced hearing loss and tinnitus.~   "
122524|NCT01452100|"~     Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring~     in elderly with severe atherosclerosis.~      In most patients, avoiding the precipitating factors and combination of statin and RAS~     inhibitor are recommended.~      The lack of randomized controlled trial in CCE precludes significant advances. The~     investigators decided to assess whether prednisone started early, at mild dosage and for a~     short period prevents death and progression to end-stage renal failure in patients with~     severe CCE, as compared to placebo.~   "
122525|NCT01452087|"~     Compare the effects of single session of exercise vs. chronic exercise training on key risk~     factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile,~     and blood pressure) in overweight adults.~   "
122526|NCT01452074|"~     the investigators first aim is to determine the effect of low intensity exercise (without~     weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these~     processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days~     without exercise in obese adults. the investigators second aim is to determine the effect of~     combining low intensity exercise training with 10% weight loss on insulin sensitivity,~     muscle lipid metabolism, and factors regulating these processes in skeletal muscle.~      Although a single 40 minute session of exercise at a low exercise intensity will not improve~     insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise~     training (6 session/wk; 12 session total) will improve insulin sensitivity and be~     accompanied by a reduction in fatty acid intermediates and a reduction in markers for~     pro-inflammatory activation in muscle. the investigators anticipate changes in insulin~     sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last~     session of a 12 wk training program (without weight-loss) will be similar to that measured~     after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of~     fatty acid intermediates, and pro-inflammatory activation will be markedly improved after~     10% weight loss when measured the day after exercise. the investigators would expect the~     improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers~     of inflammatory stress will be significantly attenuated when measured 3 days after the most~     recent exercise session, but beneficial effects of 10% weight loss on these metabolic~     endpoints will persist when compared with before weight loss.~   "
122527|NCT01452061|"~     There are three purposes to this study. The first purpose is to evaluate the value of a~     genetic test in determining risk for autism spectrum disorder. Processing for genetic~     samples will be completed at the Cleveland Clinic using research equipment provided by~     IntegraGen. The second purpose is to identify genetic changes that may be associated with~     autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is~     to examine whether genetic differences and changes may predict which individuals benefit~     from medicine used to treat attention problems or other psychiatric difficulties.~      Between 600-800 people are expected to participate in this study - approximately 300~     individuals with an autism spectrum disorder, 75 individuals with attention~     deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy~     siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.~      Study procedures will vary based upon the specific group participants are suspected to fall~     into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental~     delay, healthy sibling, or unrelated healthy control).~        -  All individuals will be asked to participate in a cheek swab (gently swabbing the~          inside of your cheek) to obtain cells used for genetic testing. Genetic material will~          be stored with identifiers such as numbers, letters or codes.~        -  Parents or caregivers will be asked to complete questionnaires that examine medical and~          family history as well as current symptoms and quality of life for the participant.~        -  Participants may undergo speech and language testing. This involves answering~          questions, looking at pictures or identifying items.~        -  Information recorded in participant medical records will be reviewed and collected for~          this study.~   "
122528|NCT01452048|"~     The investigators specific aim is to compare the relationship between systemic fatty acid~     availability and insulin sensitivity in a relatively homogenous population of obese adults.~     The investigators anticipate 1) greater systemic fatty acid availability will be associated~     with lower insulin sensitivity and 2) greater systemic fatty acid availability will be~     associated with greater accumulation of fatty acid intermediates and pro-inflammatory~     markers.~   "
122529|NCT01452035|"~     Many of the beneficial metabolic effects of endurance exercise training are not due to~     adaptations to weeks, months, or even years of training, but rather much is due to the~     response to the most recent exercise session(s). Therefore, the investigators contend that~     lifestyle interventions for obese individuals should be tailored to optimize the metabolic~     effects of the most recent exercise session(s). But the dose of exercise necessary to~     evoke these beneficial responses is not known, and the mechanisms responsible for these~     improvements are poorly understood. The findings from these studies will: 1) establish the~     minimum dose of a single exercise session necessary to improve insulin sensitivity the~     next day in obese adults, 2) characterize the underlying metabolic factors responsible for~     the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations~     that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise~     program. Findings from these studies will provide valuable information for the development~     of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise~     session in obese patients.~   "
122530|NCT01452022|"~     This is an open-label non-randomised, prospective, post market study to evaluate the~     performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving~     posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post~     operation using x-rays and CT scans. Quality of life questionnaires also used to assess~     clinical outcome measures such as pain and quality of life. Patients followed up for 24~     months after surgery.~   "
122531|NCT01452009|"~     A multi-center, observer-masked, randomized, parallel group efficacy and safety study of~     TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%~   "
122532|NCT01451996|"~     The primary goal of this study is to examine determinants of the efficacy of Claritin.~   "
122540|NCT01451892|"~     Title:~      The effect of dance-therapy on the functional capacity, body image and quality of life of~     patients with advanced obesity~      Project duration:~      33 months (August 2010 to June 2013)~      Clinical context:~      Obesity has reached epidemic proportions. The gait and balance problems in obese people and~     the associated decreased functional capacity and risk of falling highlight the need to~     evaluate the benefits of specific treatments on these problems. Attention should be paid not~     only to metabolic management but also to the physical rehabilitation required in cases of~     advanced obesity.~      Objectives:~      The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity~     (walking ability, postural control and physical activity level), body image and quality of~     life of patients with advanced obesity.~   "
122533|NCT01451983|"~     The purpose of this research is to better understand the genetic, biochemical, cognitive and~     behavioral symptom abnormalities that contribute to autism spectrum disorders. The~     investigators anticipate recruiting at least 100 participants with autism spectrum disorder~     and large head size, at least 100 participants with autism spectrum disorder without large~     head size and at least 40 healthy siblings. Biological parents are expected to be recruited~     only as genetic changes are identified in individuals with autism spectrum disorders to~     better understand the nature of these genetic changes. Participants are asked to complete~     cognitive testing, a blood draw, urine collection and measurement of his/her height, weight~     and head circumference. Parents or caregivers may be asked to complete a diagnostic~     evaluation and will complete questionnaires that examine the participant's medical and~     family history as well as his/her current symptoms, functioning, and quality of life. A~     brief report simply listing and giving a basic description of any behavioral diagnostic~     information, autism symptoms, adaptive functioning, and a listing of results from cognitive~     testing will be provided as part of this study.~   "
122534|NCT01451970|"~     Individuals have a significant capacity to adapt to different environments by changing their~     core metabolic pathways. This adaptation is especially important in regards to diet.~     Epidemiological research over the last several decades have shown that diets high in~     saturated fats have a greater ability to cause insulin resistance and the 'metabolic~     syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces~     the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats,~     as compared to high carbohydrate or high saturated fat diets, result in increased insulin~     sensitivity and improved lipid profiles.~      In this application, the investigators propose to systematically assess the effects of two~     diets enriched in either saturated or unsaturated fatty acids and determine the cellular and~     molecular mechanisms of the apparent increase in insulin sensitivity. The investigators~     hypothesize that individuals will 'adapt' to the different diets and the investigators will~     be able to generate predictive alterations in gene expression and metabolites that underlie~     the alterations in metabolism. In parallel, the investigators will test the ability of these~     different diets to affect the release of gastrointestinal hormones that may be critical to~     modulation of appetite.~   "
122535|NCT01451957|"~     Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible~     for the improvements in metabolic health after a single session of endurance exercise. The~     investigators will determine the effect of a single session of endurance exercise on~     whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of~     factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity~     (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise,~     effect insulin signalling and insulin sensitivity. Every effort will be made to recruit~     subjects from ethnic and minority groups. Before participating in the study, subjects will~     be informed of all the procedures and potential risks, and they will sign an informed~     consent form approved by The University of Michigan Institutional Review Board. Eligible~     volunteers will participate in three separate trials, in a randomized order. In two trials~     subjects will eat exactly the same amount of calories, except in one trial they will~     exercise (eucaloric + exercise) and in the other trial they will remain sedentary~     (hypercaloric). In a third trial subjects will again remain sedentary but instead they will~     ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing~     this the investigators are also able to investigate the effect of acute caloric~     perturbations on insulin sensitivity, because it is possible that the enhanced insulin~     sensitivity evident after exercise, as compared to the sedentary state, is due to caloric~     deficit and not the exercise bout, per se.~   "
122536|NCT01451944|"~     The objective of our program is to evaluate the effect of home health nurse intervention and~     education on hospital admissions, ER utilization and asthma control of Passport asthma~     patients. The investigators hypothesize that case management and in home education by nurses~     will decrease hospitalizations and ER asthma visits and improves disease control in our~     population.~      Our clinic population consists of primarily inner-city, low income, medicaid recipients.~     This population suffers from severe asthma much more than the typical pediatric population.~     Asthma remains the most frequent cause of hospital admission for our patient population.~     Home health nurse asthma education and home visits have been reported to reduce asthma~     triggers in the home and improve asthma control. The unique partnership between the~     pediatrician and the home health nurse will give us a better understanding of the health~     needs for this population, will improve quality of care and deliver more cost effective~     care.~   "
122537|NCT01451931|"~     This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared~     to computed tomography (CT) for the initial emergency room evaluation of patients with~     suspected renal colic. The investigators will compare several measures of effectiveness~     including morbidity related to the patient's underlying disease, or complications related to~     delayed diagnosis, patient status regarding pain/missed days of work, and utilization of~     health care resources based on one of three study arms: ultrasound in the Emergency~     Department, ultrasound in Radiology or CT.~   "
122538|NCT01451918|"~     Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an~     over-the-counter health supplement, has been shown to have a number of health benefits. Data~     from in vitro and animal studies suggest that it has beneficial effects on insulin~     sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic~     studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein~     metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting~     the metabolic abnormalities of insulin resistant individuals the investigators plan to~     examine the effects of resveratrol on intestinal and hepatic lipoprotein production in~     humans.~   "
122539|NCT01451905|"~     To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans~     with no skin disease~   "
122541|NCT01451879|"~     Hypothesis: the effectiveness of treatment of Pompe Disease with rhGAA enzyme replacement~     therapy (ERT) is limited at least in part because patients develop antibodies against the~     provided rhGAA enzyme. Treatment with immunomodulatory drugs may dampen or eliminate the~     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT~     efficacy. Studying the immune response to rhGAA may provide valuable insight into the role~     of the immune system in the effectiveness of ERT for Pompe Disease.~   "
122544|NCT01451840|"~     This study is designed to compare the effects of alkalinized lidocaine in the endotracheal~     tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:~        -  on the incidence of perioperative coughing~        -  on the time needed for the emergence of a desflurane-based anesthesia~        -  on the incidence of sore throat after extubation.~      The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal~     tube cuff will reduce the incidence of perioperative coughing after a desflurane-based~     anesthesia.~   "
122545|NCT01451827|"~     The purpose of this study is to compare the short-term effects of two tolvaptan formulations~     in patients with ADPKD.~   "
122546|NCT01451814|"~     The primary objective of this study is to test a manualized adaptation of positive~     psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a~     preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability,~     and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking~     cessation treatment. Both treatments will be delivered in individual 6 sessions over 6~     weeks, and will include provision of transdermal nicotine patch. The effect size estimates~     from this Stage 1b research will provide the foundation for a future application to conduct~     a large-scale, Stage II, randomized clinical trial.~   "
122547|NCT01451801|"~     Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none~     or to few antibodies after a standard immunization with 3 vaccines. These individuals are~     defined as non-responders. The investigators wish to investigate if mounting another kind of~     immune response, called the cellular immune (CMI) response, protects these non-responders.~      Aim/Hypothesis~      Primary aims:~        1. To estimate the CMI response in serologic non-responders after receiving a standard~          course of HBV immunization~           Secondary aims:~        2. To establish the prevalence of serological non-responders after a standard course of~          HBV vaccination.~        3. To assess the safety of the vaccine.~        4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a~          standard course of HBV immunization~        5. To compare the immunological profile before and after a standard HBV vaccination~          regimen on non-responders and responders~        6. Establish a rapid test for measuring CMI after being HBV vaccinated.~      A total of 400 healthy volunteers receive a standard course of immunization with a combined~     hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months~     from all participants. The blood will be analysed to see if there is antibodies or/and if~     there is mounted a cellular immune response by measuring on parameters called cytokines.~   "
122548|NCT01451788|"~     The Finnish Paediatric Orthopaedic Study Group will perform a prospective randomized,~     multicenter, clinical trial comparing Gelatin matrix with human derived thrombin (Floseal,~     Baxter) and without use of Floseal in adolescents undergoing posterior spinal deformity~     surgery for AIS (adolescent idiopathic scoliosis between 45 and 90 degrees) in Turku,~     Tampare and Helsinki Children's Hospitals. Sixty patients will be randomized into the~     intervention group receiving Floseal (n=30) and control group not receiving Floseal (n=30).~     Each University Hospital will treat 10 Floseal and 10 conventional treated scoliosis~     patients (block randomization). Both treatment groups will be allowed to use conventional~     blood saving methods.~   "
122549|NCT01451775|"~     Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and~     assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under~     fasting conditions.~   "
122550|NCT01451762|"~     Pain after ambulatory surgery remains an unsolved problem in The United States and Europe.~     It is associated with delayed hospital discharge and it can result to an increased opioid~     consumption with adverse side effects. The concept of multimodal analgesic technique was~     introduced more than 15 years ago and several techniques have been studied over the years~     including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,~     ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal~     nociceptors and C-fibers, producing pain which is further increased by neurogenically~     mediated release of substance P from afferent pain fibers. Several non-selective or H1~     -selective histamine receptors antagonists have been demonstrated in animal models and~     clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing~     properties without adverse sedative effects in patients undergoing abdominal hysterectomy.~      Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing~     postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative~     pain and other important outcomes after ambulatory surgery such as time to meet discharge~     criteria have not being studied.~      The MQOR 40 is a validated instrument that was specifically design to evaluate patient~     recovery after anesthesia and surgery. This instrument can be particularly valid to examine~     interventions which affect different spheres of patient recovery as is the case of~     diphenhydramine. The objective of this study is to determine a dose response effect of~     preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.~     The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease~     postoperative pain, opioid consumption and opioid related side effects after ambulatory~     surgery.~      The research question: Does a preoperative dose of diphenhydramine improve postoperative~     quality of recovery after ambulatory surgery? The hypothesis of this study is that~     preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and~     vomiting (PONV), sleep which will translate in a better overall quality of recovery.~   "
122551|NCT01451749|"~     The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a~     traditional Chinese herbal medicine, on cognition, function and memory in patients with~     amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's~     disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The~     results of this study may provide support for a relatively simple and inexpensive treatment~     strategy with herbal therapy that specifically targets individuals with the mild cognitive~     impairment that directly influence risk of developing dementia for older adults.~   "
122552|NCT01451736|"~     This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting~     injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode~     schizophrenia.~   "
122553|NCT01451723|"~     The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple~     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate~     (a chemical that reflects the number of neurons and their metabolism) over one year between~     people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS~     treated with a matching sugar pill.~   "
122554|NCT01451710|"~     This is a single center,prospective,no-controlled clinical trial~   "
122555|NCT01451697|"~     The primary aim of this pilot randomized controlled trial is to examine whether cognitive~     remediation, compared to a placebo, improves attention and related cognitive functions in~     patients with compulsive hoarding. The primary hypothesis is that compulsive hoarding~     patients who are treated with cognitive remediation will demonstrate improved cognitive~     skills at post-treatment compared to patients receiving placebo. This will be especially~     true of attention; memory and executive function skills may also be improved.~   "
122556|NCT01451684|"~     This is an observational study to aid in the development of a non-invasive prenatal test~     that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited~     and asked to provide a blood sample to be used for general test development purposes.~   "
122557|NCT01451671|"~     This is an observational study to develop and evaluate a blood based prenatal blood test.~     Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be~     eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical~     data that will be recorded on a case report form. All samples and clinical data will be~     stripped of subject identifiers prior to submission to Ariosa.~   "
122558|NCT01451658|"~     Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to~     undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B)~     after stabilization of their first acute bleeding.~   "
122559|NCT01451645|"~     The purpose of this study is to determine if once-daily treatment with colchicine, compared~     to placebo, is effective in preventing gout flares in patients who are initiating therapy~     with allopurinol.~   "
122560|NCT01451632|"~     The purpose of this study was to evaluate the safety and tolerability of escalating doses of~     the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.~   "
122561|NCT01451619|"~     This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of~     rosacea and to determine the safety and tolerability profile of MK-0524 in participants with~     rosacea.~   "
122562|NCT01451606|"~     This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic~     pain in women. Duloxetine is FDA approved for the treatment of other pain conditions,~     including fibromyalgia and diabetic neuropathy.~   "
122563|NCT01451593|"~     Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the~     affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack~     of optic neuritis is caused by damage to the nerve fibres in the optic nerve. There are a~     number of factors that contribute to nerve fibre damage including increased levels of sodium~     within them, so blocking sodium entry could help to protect them against damage.~      The purpose of this study is determine whether phenytoin (which blocks sodium entry into~     cells) can protect against loss of nerve fibres and prevent loss of vision after optic~     neuritis.~   "
122564|NCT01451580|"~     To determine the overall objective response rate of pegylated liposomal doxorubicin~     （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with~     metastatic breast cancer.~   "
122565|NCT01451567|"~     The purpose of this study is to examine the effect of a structured personalised ergonomic~     intervention program for hospital nurses with musculoskeletal complains.~   "
122566|NCT01451554|"~     To date, no studies have been published assessing the effectiveness of portion control~     interventions in a primary care setting. The investigators will conduct a pilot study to~     assess the effectiveness of an intervention including a portion control plate and dietary~     counseling for weight loss among obese patients in a general medicine primary care practice.~   "
122567|NCT01451541|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once~     daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.~   "
122568|NCT01451528|"~     This open label trial is conducted to investigate the efficacy and safety of umbilical cord~     blood therapy for chronic traumatic brain injury patients.~      The study hypothesis is that the participants will show significant improvement in cognition~     and function after Umbilical cord blood (UCB) transplantation.~   "
122569|NCT01451515|"~     This is a phase II clinical trial using risk-adapted therapy. The treatment is acute~     lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of~     induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months.~     Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral~     blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and~     bone marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic~     lymphoma.~      The Primary Objective of this study is:~      To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal~     disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal~     residual disease (MRD)- based risk-adapted therapy.~      The Secondary Objectives of this study are:~        -  To determine event-free and overall survival~        -  Investigate the relationship between Day 8 MRD and MDD results and EFS~   "
122570|NCT01451502|"~     For the next 5‐10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB)~     inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While~     Food and Drug Administration (FDA)‐licensed units will be prioritized, it will always be~     possible that an unlicensed unit will have known attributes, making it a better source of~     cells for the given indication. Because of the wide variety of current and potential~     indications as a source of cells for hematopoietic reconstitution or other form of cellular~     therapy, it is critical that the investigators have access to unlicensed UCB units.~   "
122571|NCT01451489|"~     This is a prospective,multicentre study to compare the efficacy, safety, tolerability and~     relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis~     (FSGS).~   "
122572|NCT01451476|"~     Skin aging is a complex process involving genetic and environmental factors. The~     investigators hope to learn more about how human genes and their function can contribute to~     skin aging and human health.~   "
122573|NCT01451463|"~     In individuals with Huntington's disease (HD), chorea may contribute to balance problems and~     difficulties with walking, sit to stand transfers and stair climbing that in turn may~     contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that~     is commonly used to reduce chorea.~      The purpose of this study is to compare: 1) spatial and temporal gait measures, 2)~     performance on functional mobility measures, and 3) amount of daily walking activity before~     and after administration of Xenazine in individuals with HD. It is hypothesized that the use~     of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers~     3) stair climbing and 4) overall daily physical activity and function.~   "
122574|NCT01451450|"~     This study will assess the clinical potency of several exposure levels of QGE031 in~     decreasing the sensitivity against peanut allergen.~   "
122575|NCT01451437|"~     This is a study of MK-8242 alone and in combination with cytarabine in adult participants~     with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms.~     Arm A is for participants with refractory or recurrent AML who are considered ineligible for~     standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in~     escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants~     will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy.~     Arm B is for participants with recurrent AML following an initial complete remission (CR) or~     CR with incomplete marrow recovery (CRi) of 6 to 12 months duration. In Part 1 of Arm B,~     participants will receive MK-8242 in escalating doses + cytarabine to determine the RP2D in~     combination with cytarabine. In Part 2, participants will receive MK-8242 + cytarabine to~     confirm the RP2D and assess preliminary efficacy. The pharmacokinetics of MK-8242 will be~     studied in both arms. With Amendment 4 (22 August 2013) a 21-day dosing cycle is added, with~     MK-8242 being given on Days 1-7 of each 21-day cycle in both the monotherapy and combination~     therapy arms; data from Arm A will be used to determine whether a participant receives~     21-day or 28-day therapy in Arm B.~   "
122576|NCT01451424|"~     To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of~     Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be~     administered vaginally.~   "
122577|NCT01451411|"~     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of~     intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in~     blood.~   "
122578|NCT01451398|"~     Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on~     either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one~     or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin~     or Technosphere Powder (placebo) added to their oral antidiabetic drugs.~   "
122579|NCT01451385|"~     The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35~     days use as evaluated with physical exam, vital signs, pulse oximetry, clinical laboratory~     tests, and AEs.~   "
122580|NCT01451372|"~     The aim of this study is to document the routine practice in continuous glucose monitoring~     (CGM) in patients treated with sensor-augmented pump therapy and to assess clinical outcome~     (HbA1c) before the start of the sensor use to the end of the follow-up period. Moreover,~     data on treatment satisfaction, and fear of hypoglycemia, cost of the therapy, side effects~     and treatment interruption will be collected.~   "
122581|NCT01451359|"~     Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized~     that it could be also used for controlling persistent air leaks while maintaining the~     drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the~     Spiration valve system designed to control air leaks in the lung that persist after lung~     surgery. This prospective observational study aims to evaluate the efficacy and safety of~     Spiration endobronchial valves in a prospective series of consecutive patients with a~     prolonged persistent air leak after anatomic surgical resection for cancer.~   "
122582|NCT01451346|"~     This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot~     study to obtain data on size and variance of treatment effects in subjects with mild to~     moderate Psoriasis.~   "
122583|NCT01451333|"~     Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at~     risk of developing HIV-related brain disease. Important factors associated with the~     development of HIV-related brain disease include therapeutic concentrations of~     antiretroviral drugs in the CNS. Conflicting evidence regarding the CNS exposure of the~     antiretroviral drug used for the encore1 study, efavirenz (EFV) have been described in~     related studies. There were recent study of two small series assessment of EFV exposure in~     the cerebral spinal fluid (CSF); one group reported small detectable EFV concentrations,~     while another observed undetectable EFV exposure in the CSF. Also, in a larger reported~     series comprising of 80 subjects on EFV-containing antiretroviral therapy, a CSF to plasma~     concentration suggested that there is limited movement of EFV out of the CSF. In HIV-1~     infected subjects at steady state, EFV plasma level parameters are dose proportional~     following 200mg, 400mg, and 600mg daily doses. The CNS exposure of EFV at different daily~     dosing has not been described.~   "
122584|NCT01451320|"~     Despite high mortality and morbidity, the best treatment strategies for prosthetic valve~     thrombosis (PVT) have been controversial. In this study the investigators wanted to identify~     the most effective and safe regimen among different thrombolytic strategies.Transesophageal~     echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive~     patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between~     1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow~     streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator~     (t-PA) (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without~     bolus (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA~     without bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and~     in-hospital mortality and non-fatal complication rates.~   "
122585|NCT01451307|"~     The aim of this single center study is to measure the impact of standardized neonatal~     pediatric surgeries due to gastrointestinal malformations on the children's motor and~     cognitive development and psycho-emotional competence.~      To measure the neurodevelopment, the children will be tested with the Bayley Scales of~     Infant Development II Assessment.~   "
122609|NCT01450995|"~     This is an open label, 6 month cross over study in 50 migraine patients fulfilling~     International Headache Society Classification criteria for migraine headache with and~     without aura having 2-6 migraines per month and not over 14 days a month of headaches in the~     previous 3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients~     will administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken~     concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and~     100mg Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3~     months. In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a~     detailed diary will be recorded regarding number of tablets taken per attack, compliance,~     rescue treatment, when patients treated their migraine attack (mild, moderate, or severe),~     onset of pain reduction (pain relief and pain free, and 24 hour pain relief and sustained~     pain free response.~   "
122586|NCT01451294|"~     Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree~     stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an~     impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes~     dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in~     this type of patients intraoperative hypotension needs to be avoided. Different short-acting~     agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a~     drug with vasoconstrictive properties combined with an increase in heart rate) can be used~     to correct intra-operative hypotension. In healthy subjects these agents affect the cerebral~     perfusion differently despite an identical effect on the systemic blood pressure. Cerebral~     perfusion decreases after phenylephrine administration while it is preserved after the use~     of ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a~     situation of an impaired cerebral autoregulation, is unknown.~      Therefore, the investigators propose to perform a prospective study observing the effect of~     phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use~     of either phenylephrine or ephedrine during CEA.~   "
122587|NCT01451281|"~     Background:~      - Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the~     protein dystrophin. Without this protein, the muscles become gradually weaker. A new~     medicine called GSK2402968 is being tested to see if it can help prevent or slow down this~     loss of muscle strength. In this study, boys with DMD and healthy volunteers will have~     different types of imaging studies to see which ones provide the best images of the muscles.~     This information will help researchers use these imaging techniques to test the safety and~     effectiveness of GSK2402968 and other agents.~      Objectives:~      - To test magnetic resonance imaging and ultrasound techniques that can detect changes in~     muscles of boys with DMD.~      Eligibility:~        -  Boys who have DMD and are in the GSK2402968 drug test study.~        -  Healthy boys of the same age as the above study participants.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Healthy volunteers will have one 2-hour visit with three tests. Magnetic resonance~          imaging (MRI) scans of the skeletal muscles and heart and diaphragm muscles will be~          carried out. Muscle ultrasound imaging of leg and arm muscles will also be done.~          Participants should not perform heavy physical activity like school sports or long~          walks during the week before the visit.~        -  Participants in the GSK2402968 study will have the same series of tests as the healthy~          volunteers. The tests will be given during the study screening phase. They will be~          repeated after 3 months and 6 months of receiving the study agent (GSK2402968 or~          placebo) and at 6 months after stopping the GSK study.~   "
122588|NCT01451268|"~     The study's primary objective is to determine the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after~     hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard~     immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome~     (MDS) or Acute Myeloid Leukemia (AML).~      Secondary objectives are~        -  To determine safety and tolerability of panobinostat~        -  To determine overall and disease-free survival at 12 months after HSCT~        -  To evaluate immunoregulatory properties of panobinostat~        -  To evaluate patient-reported health-related quality of life (HRQL)~      The hypothesis of this study is that panobinostat can be an effective drug in preventing~     relapse of MDS and AML patients with high-risk features after hematopoietic stem cell~     transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time~     reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL)~     effect.~   "
122589|NCT01451255|"~     Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early~     detection of Pulmonary Arterial Hypertension. A number of reports have provided some~     preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by~     imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI~     could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).~   "
122590|NCT01451242|"~     Following a brain injury (BI) in addition to all other systems, there can be a failure in~     the control of the autonomic system activity. Heart rate (HR) has its own normal~     variability. Heart rate is controlled by the Sympathetic and Parasympathetic systems.~     Therefore, monitoring HR variability (HRV) can help us evaluate the balance of the two~     systems and their efficiency.Decrease in HRV was found to be in correlation with death among~     patients in the acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity~     and ventricular fibrillation.This disturbance can have a great impact on the patients health~     condition. In addition there was found an inverse correlation between this situation and the~     rehabilitation outcomes. Based on this data there is a great importance in monitoring HRV~     during rehabilitation among patients following BI while the patients are required to perform~     physical activity.The aim of this work is to check whether we can replace the traditional~     way of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the~     POLAR watch.~      The aim of this work is to check if the data collected from a POLAR watch is reliable~     compared to the data collected from an EKG holter.~   "
122591|NCT01451229|"~     The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of~     higenamine in healthy Chinese subjects~   "
122608|NCT01451008|"~     The intestinal ends must be rejoined after colonic resection. Conventional methods include~     sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic~     surgery. The leakage of an anastomosis can cause serious consequences, such as abdominal~     infections and/or sepsis. Early detection of anastomotic leakage is the best way to avoid~     serious abdominal infections. The methods that are used today to detect leaks are~     unfortunately not very accurate. These methods include monitoring symptoms, temperature, and~     CRP-levels, and performing abdominal examinations and tomography scans. Because of the~     difficulties in objectively assessing these parameters, the anastomotic leaks are often~     diagnosed late. When reoperation is required, a permanent stoma may be made at the level of~     the sigmoid colon. The CARP system has been developed to achieve a safe anastomosis. The~     CARP is designed to providing an improved contact surface between the two intestinal ends~     and the ability to precisely investigate the anastomosis during and after surgery using the~     catheters of the CARP system. Standardized use of the CARP to anastomose the large intestine~     may provide significant advantages in the field of colorectal surgery.~   "
122592|NCT01451216|"~     Balance control is the sum action of the sense and reaction systems. In order to perform~     different activities in different postures one must have the ability to control and to~     adjust his balance in different conditions.A deficit in brain action following injury,~     disease or aging can undermine the ability to control balance and increase the risk to~     fall.The limitation in gait and mobility can increase morbidity. There is a limited number~     of tools evaluating and recording balance control ability. Most of this tools are~     observational and can be used in the clinical field. The aim of this work is to estimate the~     feasibility of an objective tool that can evaluate balance by tracking objective~     quantitative measures during the standard physical therapy session without using an~     expensive equipment. By using this tool the therapist can monitor the patient and collect~     quantitive data while performing tasks while keeping balance. This tool will allow the~     therapist to detect changes in balance and evaluate the effect of different conditions on~     the patients balance. This tool is based on the well known functional reach test. The~     addition of this tool to the test is the use of a simple camera and a computer softwear that~     will collect the data and analyze it while performing the test. This tool will give the~     therapist information on the responsiveness and the spatiotemporal measures of the~     performance. The aim of this work is to check what is the contribution of spatiotemporal~     measures of the functional reach test among patients suffering from acquired brain injury to~     the understanding of the motor function and balance control of people suffering from brain~     injury. .~   "
122593|NCT01451203|"~     The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with~     methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis~     (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of~     radiographically confirmed joint damage progression over a one-year period as a primary~     endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be~     discontinued, and the subjects will be monitored for one more year (the follow-up period) to~     investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory~     purposes.~   "
122594|NCT01451190|"~     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and~     female subjects with hair loss.~   "
122595|NCT01451177|"~     Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo~     from scalp, to induce hair growth in male and female subjects with hair loss.~   "
122596|NCT01451164|"~     To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients~     with schizophrenia.~   "
122597|NCT01451151|"~     The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C to~     induce hair growth in male and female subjects with hair loss.~   "
122598|NCT01451138|"~     The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji~     Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.~   "
122599|NCT01451125|"~     The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji~     Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects~     with hair loss.~   "
122600|NCT01451112|"~     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth~     in male and female subjects with hair loss.~   "
122601|NCT01451099|"~     Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects~     with hair loss.~   "
122602|NCT01451086|"~     Pneumococcal infection is a leading cause of death throughout the world and a major cause of~     pneumonia, bacteremia, meningitis, and otitis media.~      It has been established that purified pneumococcal capsular polysaccharides induce antibody~     production and such antibody is effective in preventing pneumococcal disease. Clinical~     studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in~     polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old~     and older and in adults of all ages have showed immunogenic response. In order to provide~     more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical~     trial is planed to conduct.~   "
122603|NCT01451073|"~     The purpose of the study is to evaluate the ability of injections Ji Gami(TM) to induce hair~     growth in male and female subjects with hair loss.~   "
122604|NCT01451060|"~     Anesthesia for cesarean section has been a great challenge for the anesthesiologist, for~     mother and fetus are closely related. So the challenge is to anesthetize the mother without~     interfering with the physiology of the fetus. The spinal block, although safe, are not free~     of complications if not treated properly, may be responsible for increased fetal morbidity.~     Among the major side effects, there is hypotension, with potentially serious consequences~     for the maternal-fetal dyad. Hypotension in pregnant women at low risk may not lead to major~     damage, but a pregnant woman with low reserves, as is the case of pregnant women with~     pre-eclampsia, any drop in blood pressure of the mother can bring harm to the welfare of~     mother and fetus. Based on the above, the purpose of this study is to compare the effects of~     maternal and perinatal treatment of hypotension with ephedrine or metaraminol in pregnant~     women with severe preeclampsia undergoing cesarean section under spinal anesthesia. There~     will be a randomized, double-blind, which will be included pregnant women with severe~     preeclampsia with indication of cesarean section, gestational age above 34 weeks gestation~     and only.Will be Excluded women with hemorrhagic syndromes of pregnancy, HELLP syndrome,~     eclampsia, cardiovascular or cerebrovascular disease, fetal distress and absolute~     contraindications to spinal anesthesia.~      All patients are fully informed of the research objectives and will only be included in the~     study if they agree to participate and sign the Instrument of Consent. The project was~     designed following the recommendations of Resolution 196/96 of the National Health and the~     Declaration of Helsinki for research involving human subjects (2000). In addition, the~     project was submitted to the Ethics Committee in Research of the Institute of Integrative~     Medicine Professor Fernando Figueira, is approved. The study will be conducted from June~     2011 to July 2012. The study variables are: consumption of metaraminol and ephedrine before~     and after birth, the occurrence of nausea and vomiting, incidence of maternal hypotension,~     the occurrence of reactive hypertension, occurrence of bradycardia, pH of umbilical cord,~     Apgar score 5 minutes, need for face mask ventilation and ICU admission.~   "
122605|NCT01451047|"~     To evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair~     growth in male and female subjects with hair loss~   "
122606|NCT01451034|"~     Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color~     changes in both the background atrophic and metaplastic gastric mucosa. However, the~     clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this~     study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.~   "
122607|NCT01451021|"~     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth~     in male and female subjects with hair loss.~   "
122610|NCT01450982|"~     The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics~     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.~   "
122612|NCT01450956|"~     During repair of a congenital heart defect the child is exposed to myocardial hypoxia.~     Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia~     and cardioplegic arrest than the adult. The protective effect of halogenated agents on~     ischaemia and reperfusion injury has been investigated widely in adults. The investigators~     hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better~     myocardial protection during paediatric cardiac surgery.~   "
122613|NCT01450943|"~     The primary objective of this study is to assess the effectiveness of cellular dermal~     replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of~     non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal~     efficacy.~   "
122614|NCT01450930|"~     Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement~     dose in conditions of physical or psychological stress to prevent life threatening adrenal~     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.~     gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone~     dose is crucial. The study is conducted to offer patients the possibility to perform~     hydrocortisone self administration in emergency situations in a way of administration which~     is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of~     subcutaneous hydrocortisone administration will be studied and compared to intramuscular~     administration.~   "
122615|NCT01450917|"~     Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of~     3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and~     physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to~     identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the~     left side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there~     are several methods to determine the diaphragmatic elevation from previous studies, the~     accuracy, reliability, intra and inter-observer variation are problem.~      Neurotization is the effective procedure to restore upper extremity function in root~     avulsion type. Phrenic nerve is one of the common donor nerves which used for this~     procedure. But sometimes, concomitant injury of this nerve can occur. Therefore, the~     investigators established Diaphragmatic height index (DHI) from chest radiograph to use as~     the diagnostic test for phrenic nerve dysfunction.~   "
122616|NCT01450904|"~     Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had~     the less postoperative pain and shorter recovery time compared to the conventional~     technique. With using MIS technique, less cut of quadriceps tendon was the key. It related~     to keep more quadriceps strength and improve functional performance after TKA. However,~     there was no previous studies about the effect of quadriceps incision length in the recovery~     time of the quadriceps strength. The investigators hypothesized that longer quadriceps~     incision affected the longer recovery time of quadriceps strength in MIS-TKA.~   "
122617|NCT01450891|"~     Background: New research criteria for the diagnosis of Alzheimer's disease (AD) have~     recently been developed to enable an early diagnosis of AD pathophysiology by relying on~     emerging biomarkers. To enable efficient allocation of health care resources, evidence is~     needed to support decision makers on the adoption of emerging biomarkers in clinical~     practice. The research goals are to 1) assess the diagnostic test accuracy (of current~     clinical diagnostic work-up and emerging biomarkers in Magnetic Resonance Imaging (MRI),~     Positron Emission Tomography (PET) and Cerebrospinal Fluid (CSF), 2) perform a~     cost-consequence analysis and 3) assess long-term cost-effectiveness by an economic model.~      Methods/design: In a cohort design 304 consecutive patients suspected of having a primary~     neurodegenerative disease are approached in four academic memory clinics and followed for~     two years. Clinical data and data on quality of life data, costs and emerging biomarkers are~     gathered.~      Diagnostic test accuracy is determined by relating the clinical practice and new research~     criteria diagnoses to the reference diagnosis. The clinical practice diagnosis at baseline~     is reflected by a consensus procedure among experts using clinical information only (no~     biomarkers). The diagnosis based on the new research criteria is reflected by decision rules~     that combine clinical and biomarker information. The reference diagnosis is determined by a~     consensus procedure among experts based on clinical information on the course of symptoms~     over a two-year time period.~      A decision analytic model is build combining available evidence from different resources~     among which (accuracy) results from the study, literature and expert opinion to assess~     long-term cost-effectiveness of the emerging biomarkers.~      Discussion: Several other multi-centre trials study the relative value of new biomarkers for~     early evaluation of AD and related disorders. The uniqueness of this study is the assessment~     of resource utilization and quality of life to enable an economic evaluation. The study~     results are generalizable to a population of patients who are referred to a memory clinic~     due to their memory problems.~   "
122618|NCT01450878|"~     Background : Numerous studies have outlined the cellular pleiotropic effects of~     erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as~     after acute ischemic injury of the brain or the heart. However, most of these studies were~     carried out in animal models and no definitive proof exists today to demonstrate that EPO~     has similar beneficial effects in human pathology.~      Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against~     ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.~   "
122619|NCT01450865|"~     Slow axonal Kv7 potassium channels are found along unmyelinated axons and at the nodes of~     Ranvier of myelinated axons in peripheral nerve. As such the pharmacological activation of~     Kv7 channels offers a potential means of reducing the excitability of peripheral axons. To~     determine whether this is the case for human peripheral myelinated axons, the effect of the~     Kv7 channel agonist flupirtine on the electrical excitability of A fibres was examined in~     both isolated segments of human sural nerve in vitro and in motor axons of the median nerve~     supplying abductor pollicus brevis in vivo. Axonal excitability was assessed in 21 human~     sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in~     QTRAC (© Institute of Neurology, London, UK). Strength-duration time constant, rheobase~     current, relative refractory period (RRP), post spike superexcitability at 5 and 7 ms and~     threshold electrotonus over the 90 100 ms period were used as indices of electrical~     excitability. In addition, suppression of ectopic discharge in a model of upper limb~     ischaemia.~   "
122640|NCT01450592|"~     The study is designed as an interventional (as blood investigations will be done) dietary~     survey of diabetic & non-diabetic population sample of India to understand & compare dietary~     patterns among them.The study objective is to find out amount of carbohydrate content of~     daily diet of diabetic population study . This study does not intend to study the effect of~     any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study~     will begin after the study approval by ethics committee. The subject will involved after~     they sign the consent form. The study involves general examination of patients, collection~     of data like history of disease, interview by dietitian with the help of questionnaire,~     blood investigations (only in diabetic population only) and glycaemic control status of only~     diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from~     10 study centers spread across India. The study data will be analyzed with appropriate~     statistical methods.~   "
122620|NCT01450852|"~     Exercise has been used to help prevent or slow the progression of inflammation-related~     disease; however, the mechanism by which this activity may lower concentrations of~     inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and~     MC5R) have been shown to function in an anti-inflammatory manner and have the potential to~     mediate the positive immune adaptations associated with regular physical activity.~      Preliminary data suggest that MC3R gene expression increases in whole blood after chronic~     exercise training. The primary aim of the current study is to explore whether this change in~     gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface~     expression. The secondary aim is to examine the relationship between surface expression of~     these receptors and circulating inflammatory profiles.~      The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half~     of the group will be placed on an exercise program for 15 weeks. The other half will serve~     as untrained control subjects. In addition to basic anthropometric measures, the~     investigators will measure concentrations of inflammatory and anti-inflammatory cytokines~     (ELISA) and cell surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).~   "
122621|NCT01450839|"~     This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied~     repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape~     as the control.~   "
122622|NCT01450826|"~     The objectives of the study are: 1) Primary: Assess CINV efficacy of Aprepitant in~     combination with Ondansetron vs. Ondansetron alone in preventing acute and delayed CINV~     (Complete Control (CC): days 1-7) in brain tumor patients during adjuvant temozolomide~     therapy; and 2) Secondary: To assess the efficacy of Aprepitant in combination with~     Ondansetron vs Ondansetron alone in preventing acute CINV in brain tumor patients during the~     acute period (first 24 hours) of receiving adjuvant temozolomide therapy; 3)Secondary: To~     assess the efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in~     preventing delayed CINV (days 2-7); 4) Secondary: To assess the safety and tolerability of~     Aprepitant administered concomitantly with Ondansetron; 5) Exploratory: To assess the time~     to treatment failure of Ondansetron treatment with and without Aprepitant; 6) Exploratory:~     To explore the effects of age, gender, chemotherapy history, and concomitant glucocorticoid~     on the efficacy of Ondansetron treatment with and without Aprepitant; 7) Exploratory: To~     explore the impact of Aprepitant on quality of life and daily function.~   "
122623|NCT01450813|"~     The Bispectral Index monitor is used in many operating rooms to provide information to the~     anesthesiologist about a patient's level of consciousness. The Composite Variability Index,~     or Composite Variability Index (CVI), is a new index that may provide the anesthesiologist~     with more information about the condition of the patient. The purpose of this study is to~     determine if a commonly used anesthetic drug (rocuronium) affects the CVI measurement~     differently with different doses. Rocuronium is a muscle relaxant routinely used during~     surgery. It is expected that the group given the highest dose of rocuronium will have~     diminished CVI values.~   "
122624|NCT01450800|"~     This is a study of patients undergoing gynecologic surgery who require post-operative~     catheterization to determine if prophylactic antibiotic treatment decreases the risk of~     post-operative urinary tract infection in these patients.~   "
122625|NCT01450787|"~     The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This~     might help identify a group of patients at greater risk for dry eye complications. Diabetics~     have been shown to have poor ocular surface healing and might benefit from dry eye therapy~     earlier if they are shown to be at greater risk for dry eyes.~   "
122626|NCT01450774|"~     This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way~     cross-over study in asthmatic children already treated with inhaled corticosteroids.~   "
122627|NCT01450761|"~     The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and~     Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell~     Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.~   "
122628|NCT01450748|"~     Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and~     hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and~     globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial~     because a high placebo effect can be observed. Sodium Alginate is an effective medication~     indicated for symptomatic treatment of gastroesophageal reflux. This randomized,~     double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of~     sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with~     LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux~     symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux~     finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of~     reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1~     day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study~     hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.~   "
122629|NCT01450735|"~     The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR~     is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails.~     This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS~     device.~   "
122641|NCT01450579|"~     This trial is to investigate the clinically recommended dosage for ASP7373 based on the~     comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy~     adults.~   "
122642|NCT01450566|"~     Ureteroscopy (URS) is minimally invasive procedure for management of renal stones. URS is~     often involves concomitant of an indwelling ureteral stents. Placements of these stents~     include pain, bladder irritability, infection, migration, encrustation and stones.~      Pain is one of most significant problem of ureteral stents. There are no satisfactory~     measures to deal with this problem. A novel approach to manage the pain is to load a drug~     onto ureteral stent and deliver the drug into the urinary tract at controlled release rate.~      Lidocaine has been proven to be effective for management of the pain associated with~     interstitial cystitis. This agent has the potential for management of post-URS pain.~   "
122886|NCT01447355|"~     This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral~     supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming.~     The use of cholecalciferol, a vitamin D, may keep skin cancer from forming.~   "
122630|NCT01450722|"~     Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially~     in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among~     40-74 old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent~     claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about~     10% of the patients the ischemia worsens to threat the vitality of the limb. Although~     intermittent claudication has a benign prognosis and can often treated conservatively, more~     severe forms with extensive arterial obstructions require revascularization, either open~     surgical or endovascular. Surgical bypass operations are currently the standard reference~     for treating long femoral artery obstructions. Surgical bypass operations are accompanied by~     significant acute complications and late adverse effects, especially in patients with~     associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and~     effective endovascular therapies are seeked for. The long term patency rates of~     infrainguinal balloon angioplasty (PTA) vary largely in different studies but they are~     mostly poor when long femoral arterial obstructions have been treated. Drug eluting stents~     have shown great promise in coronary artery interventions. The purpose of this study is to~     compare Paclitaxel eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using~     PTFE graft to proximal popliteal artery in the treatment of long femoral artery obstructions~     (total length of 10-25 cm) in a prospective, randomized, Finnish multi center trial with~     consecutive claudicant and chronic critical ischemia patients. The aim is to randomize~     altogether 400 patients during about two years in five universities and in 2-3 central~     hospitals. The primary end point is patency at 24 month follow up. Secondary end points are~     primary success at patient discharge, complications, 30-day mortality, target lesion~     revascularization, quality of life, and economical analysis.~   "
122631|NCT01450709|"~     A specifically formulated probiotic product comprised of defined and tested microbial~     strains may afford renoprotection in what has been generally called Enteric DialysisTM.~     However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to~     assess the potential benefits in devising a bowel-based probiotic formulation (Kibow®~     Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along~     with standardized care of treatment.~   "
122632|NCT01450696|"~     This randomized, open-label, multicenter, international Phase IIIb study will compare the~     efficacy and safety of two Herceptin dosing regimens in combination with~     cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or~     gastro-esophageal junction adenocarcinoma. Participants who have not received prior~     treatment for metastatic disease will be randomized to receive Herceptin intravenously as~     either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks~     (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease~     progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per~     meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and~     cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of~     each 3-week cycle. Herceptin will be continued until disease progression occurs.~   "
122633|NCT01450683|"~     This study evaluates if itraconazole causes a reduction in the serum levels of~     prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer~     (CRPC).~   "
122634|NCT01450670|"~     A specifically formulated probiotic product comprised of defined and tested microbial~     strains may afford renoprotection in what has been generally called Enteric DialysisTM.~     However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to~     assess the potential benefits in devising a bowel-based probiotic formulation (Kibow®~     Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along~     with standardized care of treatment.~   "
122635|NCT01450657|"~     A specifically formulated probiotic product comprised of defined and tested microbial~     strains may afford renoprotection in what has been generally called Enteric DialysisTM.~     However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to~     assess the potential benefits in devising a bowel-based probiotic formulation (Kibow®~     Biotics/RenadylTM) as a dietary supplement product for patients undergoing standardized care~     of treatment for their CKD stage 3 and stage 4 conditions.~   "
122636|NCT01450644|"~     The investigators hypothesise that H2H will result in improved symptom control and quality~     of life and may be more cost-effective than standard best practice.~      Interstitial Lung Disease (ILD) is a lung condition characterised by progressive scarring -~     known as fibrosis. This is especially seen in patients with idiopathic pulmonary fibrosis~     (IPF). There around 2,000 new patients diagnosed in the UK every year with a similar number~     of deaths.~      Fibrotic-ILD causes breathing to slowly deteriorate and as there is no cure, an estimated~     two-thirds of patients die within five years of diagnosis. Patients suffer from many~     symptoms including shortness of breath, cough, low mood and fatigue which are currently~     being poorly managed. In addition, these patients suffer a poor health related quality of~     life whilst dying from their disease.~      In the later stages of their disease, these patients often end up in hospital (see appendix~     1a) when there is no proven or effective treatment. Many die there despite wishing to be~     looked after and die at home. These patients rarely receive palliative care which may help~     to improve their symptoms, quality of life, address end of life planning needs and prevent~     hospital admission. The Hospital2Home case conference conducted in the patient's home (or~     place of their choice) aims to address this. At the case conference involving the patient,~     their carers, a specialist nurse, and all the community health professionals, a care plan~     specific to the patient will be developed. Each health professional will be aware of their~     responsibility and duties. The investigators will look at whether this results in better~     symptom control and better quality of life for the patient and their carer. The~     investigators will also examine whether this prevents emergency hospital admission and~     allows patients to die in their preferred place. The investigators will compare patients who~     receive the service immediately with those who receive it after a delay.~   "
122637|NCT01450631|"~     The purpose of this study is to compare the post-surgical standard-of-care dressing to the~     Prevena™ Incision Management System in women undergoing Cesarean section surgery.~   "
122638|NCT01450618|"~     This study will be a retrospective observational study assessing identifiable tolerability~     problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV)~     patients treated with cART regimens including one of four different protease inhibitors~     [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the~     impact of these identifiable tolerability problems on PI persistence, healthcare~     utilization, and healthcare costs.~   "
122639|NCT01450605|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Reyataz® so that the regulatory authority can manage the marketing approval~     properly~   "
122643|NCT01450553|"~     A 15-gene lung signature was created to identify predictive and prognostic biomarkers for~     Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a~     microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk~     and low risk cohorts with significantly different survivals.~      Using fresh frozen tissue can be challenging, so this study attempts simplify the process by~     migrating the 15-gene signature from fresh frozen to two alternative tissue formats:~     Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.~      The gene expressions of the different tissue formats will be compared to see if the fresh~     frozen tissue results are similar to the alternative tissue formats.~   "
122645|NCT01450514|"~     This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a~     single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment~     with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests~     and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive'~     symptoms, as well as on cognition, motivation, subjective well-being of patients, negative~     symptoms, general psychopathological symptoms and safety/tolerability.~   "
122646|NCT01450501|"~     Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the~     epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with~     the acute form of the disease. Knowing that only 40% of all infected people develop~     symptoms, the number of infected people (and potential candidates for chronic Q-fever) are~     much higher. Chronic Q-fever generally manifest itself after a couple of months or years~     after the primary infection (in 1-5% of all cases). The clinical presentation can be a~     life-threatening and frequently underdiagnosed disease, as endocarditis, infected aneurysm~     and vascular prosthesis or chronic Q-fever related to pregnancy and immunecompromised~     patients. That's why a screening program is started in the endemic area and trace patients~     with chronic Q-fever. So eventually, a greater group of patients with chronic vascular~     Q-fever can be described. In addition, there is still no therapeutic guideline for~     management of chronic Q-fever in patient with a vascular chronic Q-fever.~      Patients with an aneurysm or vascular graft will be screened for chronic Q-fever. Patients~     with chronic Q-fever will be included in a follow-up program, in which additional research~     and treatment will start. The initial treatment of patients with chronic Q-fever is~     doxycycline and hydroxychloroquine for at least 18 months. In addition, patients will be~     monitored in 3-monthly controls, blood samples and imaging will be done. Parameters as~     complaints, titers, circulating DNA, grow of aneurysm, complications etc. will be~     investigated.~      Ultimately, the current therapeutic guideline for management of C. burnetii will be~     evaluated if it can also be applied for patients with vascular chronic Q-fever.~   "
122647|NCT01450488|"~     The purpose of this study is to evaluate the activity of oral AB1010, administered at two~     dose levels during 3 years to patients with primary or secondary progressive multiple~     sclerosis.~   "
122648|NCT01450475|"~     Cardiac surgery is associated with cardiac and cerebral injury because of~     ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC),~     have been shown to reduce the extent of myocardial infarction (MI). As another ischemic~     conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose~     of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic~     postconditioning in children undergoing cardiac surgery, as a single-center, randomized~     controlled trial.~   "
122649|NCT01450462|"~     Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in~     the vagina declines and is replaced by other bacterial species. BV is the most common~     vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is~     associated with a 60% increased risk of HIV acquisition as well as numerous other~     detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in~     women in the United States (US): 23% of white women versus. 52% of black women have BV. The~     investigators hypothesize that inadequate vitamin D contributes to BV development and/or~     recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms~     associated with pathogen elimination and to regulate immune response. According to~     nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two~     recent analyses, low vitamin D was associated with higher BV prevalence in pregnant~     African-Americans; a third replicated this finding in pregnant African-American and white~     women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to~     assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a~     public sexually transmitted disease (STD) clinic. This small (n=150), two-arm,~     placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform~     the development of future large-scale RCT design and implementation.~   "
122650|NCT01450449|"~     This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to~     two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance~     Status and extent of the surgical resection.~      This study will assess the effect of a one-week radiotherapy regimen in comparison with a~     three-week radiotherapy regimen on the survival of elderly and/or frail patients with~     glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly~     and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% -~     100%).~   "
122651|NCT01450436|"~     Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since~     the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic~     input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices~     and strategies have significantly evolved during these last years, influenced by Baker~     nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could~     perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity~     and cardio-vascular pathology prevalence in this target population at adulthood. In this~     context many studies emerged since 2000 and try to assess the trade-off between~     neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between~     heterogenous proteic input dispensed in our NICU (described by tercil methods on population)~     and fat mass phenotype variations at discharge (described by tercil methods); and its~     consequences on neurodevelopmental growth. Understanding how particular nutritional~     exposition could determine fatty phenotype and impact neurodevelopment is clearly our main~     goal.~   "
122726|NCT01449448|"~     Injection with corticosteroid is one of the most common non-operative interventions in the~     treatment of subacromial impingement; however, its use is limited by its potential side~     effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The~     objective of this study was to compare the efficacy of subacromial injection of~     triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with~     external shoulder impingement syndrome were included in this double-blinded randomized~     controlled clinical trial. Each patient was randomized into the Steroid group or NSAID~     group.~   "
122727|NCT01449435|"~     The purpose of this study is to determine whether parameters of the pulmonary function tests~     and the bronchial hyperresponsiveness to methacholine are predictors of asthma~     exacerbations.~   "
122652|NCT01450423|"~     Epilepsy is a chronic neurologic disorder characterized by seizures. Beside seizures people~     suffering from epilepsy experience several challenges related to education, work and~     everyday life such as learning-, problem-solving-, memory-, concentration-, attention~     difficulties and fatigue.~      It is generally approved that physical activity (PA) has a positive effect on physical as~     well as mental factors. However, people with epilepsy are found to be less active and PA is~     rarely offered or recommended as supplement to anti-epileptic medical treatment. Few studies~     have investigated the effect of PA in subjects with epilepsy and additional studies of high~     methodical quality are needed to enable evidence-based information and counselling.~      This study is carried through as a randomized controlled trial which investigates the effect~     of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic~     Epilepsy aged 15-50.~      The study hypothesis is that participation in a 10-week cardio exercise program will induce~     a positive change in cognitive function (concentration and attention) and possibly in~     brain-derived neurotrophic factor (BDNF). In addition it is expected that the intensity and~     duration of the 10-week cardio exercise program is sufficient to cause changes in~     physiological parameters related to a reduced risk of lifestyle diseases.~   "
122653|NCT01450410|"~     Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present~     an altered composition of high-density lipoproteins (HDL) which is associated with a loss of~     their anti-atherogenic effects and of their arterial endothelium function.~      Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the~     alterations of the HDL composition and endothelial function in patients with PIHD and~     elevated HDL-C.~      Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study,~     who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C~     ≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C <100mg/dL. This is a~     double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will~     be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL~     composition will be studied through density gradient preparative ultracentrifuge separation~     and FBLC (fast protein liquid chromatography) and through the changes in vasodilation~     induced by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content~     associated to treatment. Secondary endpoints: variations in the change of the brachial~     artery diameter with reactive hyperaemia and changes in the content of other lipid and~     protein components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in~     HDL composition and endothelial function will be assessed with an analysis of variance with~     repeated measurements and a 2x2 design.~   "
122654|NCT01450397|"~     The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.~   "
122655|NCT01450384|"~     This phase I trial studies the side effects and best dose of giving pemetrexed disodium and~     sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed~     disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors~     by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib~     tosylate may kill more tumor cells.~   "
122656|NCT01450371|"~     Interferential electrical stimulation (IES) increases local blood flow. It is not known~     whether increases in blood flow may be caused by inhibition of sympathetic activity,~     mediated by muscle metaboreflex activity. The purpose of this study was to evaluate the~     effect of IES on metaboreflex activation in healthy subjects.~   "
122657|NCT01450358|"~     The objective of this study is to evaluate the consumption of antimicrobial therapy in~     patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures~     to identify the etiological agents of sepsis.~   "
122658|NCT01450345|"~     The study carry out is to determine whether the use of oral pregabalin premedication to~     assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in~     post-operative pain management.~   "
122659|NCT01450332|"~     The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL~     prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as~     major adverse treatment events (AEs). it is designed to test the hypothesis that there is a~     difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using~     autografts and those in which such procedure was performed with the Tavor prosthesis.~   "
122660|NCT01450319|"~     This national, multicenter, open-label phase 2 study without any control arm aims to~     evaluate the activity of cetuximab monotherapy in the treatment of refractory colorectal~     cancer in subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no~     therapeutic alternative for treatment. Failure of the first and second line conventional~     therapeutic lines was documented.~   "
122661|NCT01450306|"~     The aim of the present study is to determine whether people receiving d-cycloserine and~     exposure therapy show different brain reactions to symptom provocation compared to people~     receiving placebo and exposure therapy.~   "
122662|NCT01450293|"~     Infants in malaria-endemic regions of Africa are an important target for vaccination against~     malaria in view of the enormous disease burden of malaria in this population. The purpose of~     this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP~     candidate vaccines in healthy children in a malaria endemic region. The regimen proposed~     here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may~     be protective against naturally acquired infection in the Gambia. Administration of AdCh63~     ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two~     weeks from the administration of routine infant immunisations, given according to the~     Gambian EPI.~   "
122663|NCT01450280|"~     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63~     CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite~     protein. All volunteers recruited will be healthy adults. They will be primed with various~     doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a~     booster vaccination with MVA CS administered via intramuscular route. Safety data will be~     collected for each vaccination regimen. Secondary aim of this study will be to assess the~     immune responses generated by vaccination.~   "
122887|NCT01447342|"~     A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of~     the cryo-touch II device for the treatment of forehead and/or glabellar lines~   "
122664|NCT01450267|"~     Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population~     with considerable morbidity and reduced life expectancy.~      Excessive oxidants released by activated inflammatory cells and persisting infections are~     considered the main mechanism of damage of respiratory epithelium in CF.Glutathione (GSH)~     represents the first-line defence of the lung against oxidative stress-induced cell injury;~     however, a depletion of its levels has been observed in the airways of patients affected by~     CF. In vitro studies have showed that CFTR protein plays a pivotal role in transmembrane~     glutathione transport. Therapeutic approaches with inhaled GSH could improve the reduced~     lung antioxidant capacity in order to counterbalance the oxidant stress linked to the~     chronic airway inflammation and bacterial infection.~      Primary objective of the study is to investigate whether a 12 months treatment with inhaled~     GSH can improve airway obstruction in CF patients. Secondary objectives include the effects~     of GSH therapy on exercise capacity, body mass index (BMI), respiratory symptoms, quality of~     life, frequency of pulmonary exacerbations, hospital admissions, and antibiotic~     administration. Moreover the study will evaluate the effect of GSH therapy on markers of~     oxidative stress in exhaled breath condensate (EBC) and in serum, and on inflammatory~     markers on brushed nasal epithelial cells.~   "
122665|NCT01450254|"~     The purpose of this study is to:~        1. Analyze the short-term effects of external center of pressure manipulation of the foot~          in idiopathic hip osteoarthritis patients during gait on:~             1. Gait parameters (spatiotemporal, kinematic, and kinetic)~             2. Muscle activation patterns of the lower limbs and back~        2. Analyze the long-term effects (during the period of one year) of external center of~          pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait~          on:~             1. Gait parameters (spatiotemporal, kinematic, and kinetic)~             2. Motor learning and muscle activation patterns~             3. Energy consumption~             4. Pain, physical function, and quality of life~      The hypotheses of the study, in reference to the aforementioned study objectives are:~        1. Changes in foot center of pressure will have an immediate effect on gait parameters and~          muscle activation patterns of the lower limbs and back.~        2. Long-term manipulation of foot center of pressure, as a result of a year-long~          rehabilitation program using the AposTherapy Biomechanical System, will result in~          improvement in gait parameters, changes in muscle activation patterns as a result of~          new motor learning, improvement in energy consumption, decrease in pain, improvement in~          physical function, and improvement in quality of life.~   "
122666|NCT01450241|"~     The purpose of this study is to determine whether short-course antibiotic therapy is safe~     and effective for the treatment of cancer patients with febrile neutropenia.~   "
122667|NCT01450228|"~     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy~     to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging~     study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.~   "
122668|NCT01450215|"~     This is:~        -  A prospective, randomized, open, phase II, multi-centre, interventional study. Patients~          who are in at least PR and have received lenalidomide as 2nd line treatment for MM will~          be recruited.~        -  The patients will be randomized into two groups. Group R will receive lenalidomide 25~          mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of~          lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22~          of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two~          consolidating cycles per patients.~   "
122669|NCT01450202|"~     Compared with performing each procedure individually, performing two combined procedures~     such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases,~     abdominal distension and post-procedure pain because of longer procedure time related to~     more bowel insufflated gas than one procedure. To the best of the investigators knowledge,~     there has been no randomized controlled trial of CO2 versus air for insufflations during~     combined two procedures, colonoscopy with consecutive EGD. And there are a few well~     randomized trials concerned CO2 insufflation in patients receiving sedation during~     colonoscopy.~      The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural~     abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety~     of CO2 insufflation when it is used during procedure in sedated outpatients.~   "
122670|NCT01450189|"~     This pilot study will assess the feasibility for the potential public health benefit of~     behavioral and antiretroviral interventions during acute HIV infection.~      Central Hypothesis The investigators hypothesize that delivering behavioral and~     antiretroviral interventions to acutely infected persons will reduce onward transmission.~   "
122671|NCT01450176|"~     The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine~     hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution~     1.5%) two times a day (BID).~   "
122672|NCT01450163|"~     Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may~     induce side effects, such as a specific injury to peripheral nerves called neuropathy.~     Ox-induced neuropathy is frequently painful. The presence of pain after its administration~     may hamper the full chemotherapeutic treatment of patients with colorectal cancer receiving~     this agent. Recently, it has been suggested that the appearance of acute neuropathy after~     oxaliplatin (Ox) infusion could predict the distal polyneuropathy seen some months after~     treatment. These two adverse events related to Ox treatment probably share different~     mechanistic backgrounds. However, recent experimental data suggest that both types of~     peripheral neuropathies are able to induce central sensitization, a major step to the~     occurrence of chronic pain. Pregabalin is a molecule used to teat neuropathic pain since it~     can diminish the peripheral sensitization seen in this painful condition. Recently, it has~     also been shown that pregabalin can be used to treat neuropathic pain related to Ox~     treatment. In the present study, we will test the hypothesis that Pregabalin administrated~     exclusively for three days before and three days after the Ox infusion is able to prevent~     the occurrence of pain secondary to both the acute and chronic Ox-associated neuropathies.~     In the classical FLOX chemotherapeutic regimen, Ox is infused in nine sessions during a~     six-month period. Patients will be followed for a year and nerve conduction tests,~     quantitative sensory evaluation, pain, quality of life and functional scales will be used to~     assess the impact of this strategy in the prevention of pain. If this strategy proves to~     work, this information will have a major impact in the cancer prognosis of patients with~     colorectal cancer since Ox will be able to administer in its full dose, and will not be~     limited by neuropathic side effects.~   "
122728|NCT01449422|"~     The main objective of this trial is to demonstrate that a local care strategy using URGO 310~     3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre~     dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged~     on the planimetric relative regression of the wound surface area after six weeks of~     treatment.~   "
122673|NCT01450150|"~     Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or~     de-activate neurons in superficial regions of the brain through the induction of weak~     electric currents in the brain tissue delivered by two scalp electrodes. Initial studies~     have shown tDCS to be effective for treating major depressive disorder (MDD), although there~     are negative trials in the specialized literature. One reason for these discrepant results~     might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is~     still insufficient to produce consistent clinical improvements. Thus, we intend to assess,~     in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over~     the left dorsolateral prefrontal cortex is associated with a significant clinical~     improvement when compared to sham tDCS. The investigators hypothesize that subjects~     receiving active tDCS will present with significantly higher response and remission rates at~     weeks 3.~   "
122674|NCT01450137|"~     Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older~     than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and~     course of GCA, reducing the likelihood of vascular complications that could lead e.g. to~     blindness. However, relapses usually occur when GC dosages are tapered, resulting in~     frequent re-treatment with high cumulative dosages of GC over time with substantial toxicity~     and morbidity (e.g. diabetes mellitus, infections, enhanced cardiovascular risk,~     osteoporotic fractures, cataracts).~      Therefore, novel therapies are needed that effectively reduce the dose and duration of GC~     treatment and provide more durable remissions of GCA.~      Tocilizumab (TCZ) is a humanized monoclonal antibody directed against the human~     interleukin-6 receptor (IL-6R). Elevated tissue and serum levels of IL-6 have been~     implicated in giant cell arteritis. Inhibition of IL-6 and/or its receptor therefore~     represents a new and novel approach for the treatment of RA.~      The primary endpoint is the proportion of patients that have achieved complete remission of~     disease after treatment with TCZ compared to treatment with placebo at week 12. All patients~     will receive glucocorticoids in a standardized form.~   "
122675|NCT01450124|"~     To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or~     clinically isolated syndrome and to describe the effect of Boswellic acids on the disease~     activity as assessed by monthly MRI measures.~   "
122676|NCT01450111|"~     Primary objective of this trial was to investigate the pharmacokinetics of single dose and~     repeated dose applications of lacosamide in healthy male Korean subjects.~   "
122677|NCT01450098|"~     The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and~     to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese~     subjects and first generation Japanese subjects after receiving a single oral dose of~     LY2484595 in a fasted state, after eating a low-fat meal and after eating a high-fat meal.~   "
122678|NCT01450085|"~     The specific aims of this project are: (1) to compare the impact of using the routine~     screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and~     HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert~     algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related~     outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and~     GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a~     disruptive technology10 that could allow TB/HIV programs in resource-limited settings to~     leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key~     barrier to scale up of ICF and IPT.~   "
122679|NCT01450072|"~     The Departments of Neurology and Neurosurgery are conducting this research study to evaluate~     the safety and effectiveness of intravascular angioplasty for the treatment of venous~     narrowing in the treatment of Multiple Sclerosis (MS).~   "
122680|NCT01450059|"~     The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed~     Newborns after spontaneous birth in comparison to cesarean section.~      This may have an influence on the risk of vertical HiV transmission.~   "
122681|NCT01450046|"~     The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression~     of pancreatic cancer cells. Therefore, the investigators must determine the safety and~     tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to~     cancer patients. The investigators will do this by giving participants a dose of up to1600~     mg twice a day, not to exceed 3200 mg total for 14 consecutive days.~   "
122682|NCT01450033|"~     Adolescents with solid organ transplants have poorer outcomes than adults, and do not~     respond as well to post-rejection treatment. In addition to well-recognized declines in~     individual health-related quality of life, premature graft loss creates considerable health~     and economic burdens. High nonadherence rates among adolescents are believed to contribute~     majorly to rejection, premature allograft dysfunction and failure. Studies suggest that a~     telephone-based peer mentoring approach, with texting and e-communication, is a promising,~     practical means to promote medication adherence in adolescent solid organ transplant~     recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring~     to improve medication adherence and health-related quality of life vs. usual care in~     adolescents and young adults with solid organ transplants, and 2) to determine the~     mechanisms through which peer mentoring impacts medication adherence and health-related~     quality of life.~   "
122683|NCT01450020|"~     This randomized clinical trial studies peer navigator education in improving survivorship~     care in African American breast cancer survivors. An educational intervention involving peer~     groups may help to improve the well-being and quality of life (QOL) in breast cancer~     survivors~   "
122729|NCT01449409|"~     The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of~     real-time identification of uncontrolled asthma by electronic administrative records linked~     to real-time notification of uncontrolled status to patients and asthma specialists with~     recommended guideline directed intervention by physicians. The investigators hypothesize~     that real-time outreach following National guideline asthma care recommendations, after~     real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled~     corticosteroids will lead to better improvements in asthma control (impairment and risk)~     compared to standard asthma care outreach.~   "
122730|NCT01449396|"~     The aim of the study is to prove that acupuncture applied before and after embryo transfer~     is able to increase pregnancy rates by means of reducing stress and improving endometrial~     vascularization in women receiving in vitro Fertilization (IVF) treatments.~   "
122684|NCT01450007|"~     Pre-operative perineural injection of dexamethasone mixed with local anesthetic in~     peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of~     analgesia, improve visual analog pain scores, decrease post-operative opioid use, and~     decrease post-operative nausea. No study has been published to determine if this effect is a~     result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal~     activity at the injection site. This study is a prospective, randomized, double-blind,~     controlled study to compare pain block with (1) ropivacaine and saline plus intravenous~     saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and~     saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned~     to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected~     perineurally in combination with ropivacaine for interscalene brachial plexus block will~     yield longer duration of sensory blockade as compared to ropivacaine alone without~     intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous~     dexamethasone. This result will suggest that the effect of dexamethasone is a result of~     direct neuronal activity at the injection site versus systemic absorption.~   "
122685|NCT01449994|"~     The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg~     pain in juvenile athletes.~      A randomized placebo controlled clinical trial including juvenile athletes with functional~     impairment and pain in thigh, leg or foot is performed.~      Hypothesis: Instrumental chiropractic treatment with the activator instrument following~     the activator methods diagnostic evaluation should lead to significant improvement of~     complaints and functional impairment compared to the control group treated by a deactivated~     instrument following a sham evaluation protocol.~   "
122686|NCT01449981|"~     This study is the first to develop and test in a randomized experimental design the efficacy~     of an integrated 12-step facilitation intervention tailored for young people. In the first~     phase of the study, the investigators are developing and revising a preliminary manual for~     the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and~     subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will~     integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the~     preliminary integrated TSF protocol. In the second phase of the study, the investigators~     will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized~     experimental design for adolescent substance use disorder with 60 adolescents. As a result,~     the investigators will examine potential mechanisms that may underlie the efficacy of iTSF~     in improving alcohol and other drug use outcomes. The investigators will test group~     differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics~     Anonymous attendance and involvement) and whether these variables are associated with~     substance use outcomes.~   "
122687|NCT01449968|"~     The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce~     the geriatric hospital inappropriate (especially for emergencies) to 1 month.~      The primary endpoint: survival without hospitalization through the emergency inappropriate~     to 1 month.~   "
122688|NCT01449955|"~     The purpose of the proposed study is to determine if pairing reactivation of a traumatic~     memory with a single administration of Rapamycin (e.g., Sirolimus) in men with~     combat-related Posttraumatic Stress Disorder leads to a reduction of the emotional strength~     of that particular traumatic memory.~      The following hypotheses will be tested:~        1. Traumatic memory reactivation paired with a single dose of Rapamycin will decrease~          objective measures of stress and self-report of stress during replay of the traumatic~          memory, relative to, subjects receiving placebo.~        2. Pairing administration of Rapamycin with traumatic memory reactivation will decrease~          symptoms of Posttraumatic Stress Disorder one month and three months later, relative to~          patients receiving placebo.~   "
122689|NCT01449942|"~     The purpose of this study is to determine whether an EBV-LMP1 targeted DNAzyme is effective~     in radiosensitization of nasopharyngeal carcinoma in combination with standard radiation~     therapy.~   "
122690|NCT01449929|"~     This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy~     (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg~     once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once~     daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside~     reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or~     tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and~     background NRTI selection. The primary analysis will take place after the last subject~     completes 48 weeks on therapy; an additional analysis will be conducted after the last~     subject completes Week 96 on study.~   "
122691|NCT01449916|"~     This study is a randomized control trial assessing the impact of a simple evidence-based~     protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a~     scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood~     transfusion when necessary. It is hypothesized that the protocol will significantly decrease~     in-hospital mortality in patients with severe sepsis.~   "
122692|NCT01449903|"~     The purpose of this study is to compare three different core build-up materials for dental~     use. The study hypothesis is that there is no differences in survival rate of the different~     core build-ups.~   "
122693|NCT01449890|"~     The primary objective of this study is to test in a randomized effectiveness trial if e-mail~     delivered cognitive behavioural treatment is an effective follow-up care approach in the~     treatment of depression under clinically representative conditions.~   "
122731|NCT01449383|"~     This study aims to investigate the direct effect of high amounts of dietary fibre and high~     amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity~     markers in healthy adults.~   "
122732|NCT01449370|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal~     biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of MLN1117 when~     administered orally in subjects with advanced solid malignancies.~   "
122733|NCT01449357|"~     A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients~     with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine~     Kinase Inhibitors.~   "
122734|NCT01449344|"~     The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose~     ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with~     relapsed or refractory mantle cell lymphoma.~   "
122694|NCT01449877|"~     The investigators study aims to determine the effect of prophylactic therapy with~     Trimethoprim-sulfamethoxazole on the recurrences of toxoplasma retinochoroiditis gondii.~     This is a randomized, double-masked, in patients with eye condition of acute Toxoplasma~     gondii retinochoroiditis. Volunteers will be recruited with a previous diagnosis of~     chorioretinitis presumed Toxoplasma gondii, which show active lesions compatible with~     recurrence. After the acute phase of treatment of all patients [1 tablet~     Trimethoprim-sulfamethoxazole (800/160mg) 12/12h during 45 days], the same Stratified by~     gender) will be randomized in a 1:1 ratio between the group 1 - TMP-SMZ (prophylactic~     treatment with trimethoprim-sulfamethoxazole 1 tablet every other day for 311 days) or group~     2 - placebo (consisting of a placebo pill containing no active ingredient of similar~     appearance to trimethoprim-sulfamethoxazole, 1 tablet every other day for 311 days). The~     primary outcomes are incidence of episodes of recurrent chorioretinitis by toxoplasmosis in~     the follow up of 12, 36, 48, 60, 72, 84, 96, 108, and 120 months. Patients will be followed~     during the ten years in uveitis clinic at intervals defined as follows: return weekly for 4~     weeks, then monthly for 2 months, then each 3 months for 9 months, and finally annually for~     10 years.~   "
122695|NCT01449864|"~     The primary objectives are to determine feasibility and the acute toxicity profile of proton~     therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to~     determine late toxicities and to generate preliminary data on clinical efficacy.~   "
122696|NCT01449838|"~     This is a clinical study protocol for a single centre, randomized, double blind, placebo~     controlled, single and repeat dose study to investigate the safety, tolerability and~     pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in~     healthy Japanese male subjects.~      Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or~     placebo as a single dose and twice daily for 2.5 days by intravenous infusion.~      Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals~     after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),~     safety laboratory data, renal function and review of adverse events.~   "
122697|NCT01449825|"~     Pazopanib is approved by the FDA and EMA as targeted therapy for the indication of advanced~     renal cell carcinoma (RCC). Hepatic safety events were observed in the pazopanib pivotal~     clinical trial and the U.S. pazopanib label information contains a 'black box warning'~     regarding hepatotoxicity. These clinical observations have prompted GSK to undertake a~     proactive pharmacovigilance strategy focused on hepatic safety that goes beyond spontaneous~     reporting of adverse events.~      The goals of the study are to assess prescriber compliance with pazopanib label guidelines~     for liver monitoring among patients with RCC, as well as to quantify and characterize the~     hepatic safety profile of the product in real-world clinical practice compared to other~     anti-vascular endothelial growth factor (anti-VEGF) drugs. As part of regulatory~     commitments, GSK will conduct parallel epidemiologic analyses in different patient~     populations as represented in multiple databases of electronic medical records. To enhance~     accrual of data, GSK will conduct this safety surveillance program simultaneously across~     datasets in order to detect and characterize all cases of liver enzyme elevations in diverse~     populations of patients receiving pazopanib. Two additional goals of this study are to~     evaluate the incidence of cases of combinations of liver enzyme elevations indicative of~     Hy's Law and drug-induced acute liver failure among users of pazopanib compared to users of~     other anti-VEGF drugs. This research effort will be coordinated by an external coordinating~     center.~      An epidemiologic cohort study design, nested in several databases of electronic medical~     information, will be employed for the research questions. Following the availability of~     pazopanib in the relevant medical care system, the study will collect retrospective data at~     regular intervals over the course of four years among persons exposed to pazopanib and other~     anti-VEGF agents. Each patient will be characterized based on additional available~     information in the database (e.g., demographics, concomitant medications). Elevations in~     liver enzymes will be identified through laboratory data captured in these databases.~     Potential Hy's Law and acute liver failure cases will be identified through established~     screening criteria, and screen-positive cases will be reviewed by an adjudication committee~     of hepatologists for final determination of drug-associated causality.~   "
122698|NCT01449812|"~     The purpose of this booster study is to evaluate the immune persistence in healthy Chinese~     subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib)~     vaccine. The study will also evaluate the safety and immune response of these subjects to a~     booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT01086423).~   "
122699|NCT01449799|"~     In the current study GSK961081 and fluticasone propionate will be administered in a blended~     formulation from a single device and compared with GSK961081 and fluticasone propionate~     administered alone and concurrently. This is a single centre, randomized, double-blind,~     double dummy, single dose, four way cross-over study investigating the pharmacokinetics and~     pharmacodynamics of GSK961081 and fluticasone propionate when administered alone,~     concurrently and as a combination blend in healthy subjects.~   "
122700|NCT01449786|"~     More than 70% of birch pollen allergic patients suffer from allergic reactions to certain~     foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy~     (SIT) with birch pollen extract is not effective for the treatment of associated food~     allergy in a substantial number of patients. Based on our previous clinical and~     immunological investigations of birch pollen related food allergy (BPRFA) the investigators~     hypothesize that for effective SIT of this abundant food allergy the disease-eliciting food~     allergens should be employed. To prove this concept, the investigators aim to sublingually~     administer the major apple allergen, Mal d 1, to birch pollen-allergic patients with~     concomitant apple allergy and evaluate clinical and immunological effects of this treatment.~     The investigators choose Mal d 1 as model food allergen because (i) its cross-reactivity~     with Bet v 1 has been well characterized,(ii) apple is the most frequent trigger for BPRFA~     and (iii) recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20~     birch pollen-allergic patients in a previous study. Sublingual administration of a defined~     concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a~     positive control and placebo-treatment. Clinical parameters will include skin prick tests~     (SPT) and objective and subjective assessment of apple and birch pollen-induced allergic~     symptoms. Immunological parameters will comprise the analysis of antibody and T cell~     responses to Mal d 1 and Bet v 1 as well as the evaluation of basophil activation.~      The proposed pilot study will be a first investigation of the concept to specifically treat~     BPRFA with the involved food allergens and thus, represents an important step in the~     development of an efficient and safe therapy in the future.~   "
122735|NCT01449331|"~     The purpose of this study is:~        -  to estimate the frequency of the use of non invasive ventilation~        -  to estimate the frequency of the use of palliative non invasive ventilation~        -  to evaluate the impact of non invasive ventilation~        -  to propose some recommendations~   "
122701|NCT01449773|"~     The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in~     patients with type 2 diabetes are now thought to be attributable to elevated intestinal~     production and reduced clearance. Substantial evidence exists indicating that elevated~     plasma levels of these lipoproteins are associated with increased cardiovascular disease~     risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels~     of intestinal origin appears to be crucial to improve CVD risk associated with type 2~     diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic~     dyslipidemia. However, the investigators understanding of the physiological changes that~     occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators~     appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3~     PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal~     lipid absorption and chylomicron synthesis have not yet been examined in humans. The general~     objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs~     beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The~     investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:~        -  reduce TRL apoB-48 production rate and increase fractional catabolic rate of these~          lipoproteins,~        -  decrease the expression of genes that regulate intestinal lipid absorption and~          synthesis as well as synthesis of apoB-48-containing lipoproteins,~        -  decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.~   "
122702|NCT01449760|"~     Physical activity and in particular sport is beneficial to health. Nevertheless, some of~     these activities may create a risk of injury. Ankle sprain is the most common sport related~     injury. Sports that are causing the highest number of ankle sprains are: football (30%),~     handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling~     (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a~     total of 1.3 million sports injuries. 47% of these patients required medical care. The total~     costs (direct and indirect) were assessed 84.240.000 EUR per year.~      Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of~     re-injury during the first year after the trauma, and in half of patients with an ankle~     sprain recurrence this could lead to instability or chronic pain of the ankle.~      The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some~     hospitals, therapists are beginning to use it for the rehabilitation of patients after~     surgery, fractures or strokes.~      Patients are asked to complete their physical therapy session by practicing sports via~     video games such as skiing, bowling or hula hoop. Currently, there are no randomized~     controlled studies that publish on the effectiveness of this tool. Recently, a study~     investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint~     mobility and level of physical activity. After 10 weeks of training, people an increased~     strength and balance was found. However, these results still require statistical~     confirmation. Thus this objectives of this study are~        -  To assess the efficacy of exercise training with the Wii Balance Board ® Platform~        -  To evaluate the effectiveness of physical therapy (based on current guidelines)~        -  To compare these two types of care (conventional physiotherapy versus Wii) to a control~          group (non-treatment).~   "
122703|NCT01449747|"~     The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor~     in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4~     inhibitor~   "
122704|NCT01449734|"~     There is increasing awareness that high-quality care in the intensive care unit also~     includes care of visiting family members according to their needs. The investigators~     therefore want to assess family satisfaction using a questionnaire that was specially~     developed for this setting and recently validated for German-speaking participants.~   "
122705|NCT01449721|"~     The purpose of this study is to assess the ability of an empiric resuscitation strategy~     compared to standard care to decrease the incidence of organ failure in normotensive sepsis~     patients.~   "
122706|NCT01449708|"~     Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after~     surgery and general anesthesia. The results of our observational study indicate that 42.7%~     of patients require medication to treat PONV in the first 24 hours after bariatric surgery~     despite our aggressive perioperative approach with triple prophylaxis. Common risk factors~     for PONV are the use of intraoperative narcotics and anesthetic gases.~      Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a~     reduction of narcotic consumption, desaturations and use of antiemetic medication.~      Our study hypothesis is that different types of anesthetics reduce PONV further.~      Patient would be randomly assigned to receive either our current intraoperative management~     or a narcotic free, total intravenous general anesthetic (TIVA).~      The investigators hope to improve patients' satisfaction by reducing PONV in the~     postoperative period.~   "
122707|NCT01449695|"~     The purpose of this study is to investigate whether a nurse-based intervention, consisting~     of structural informative consulting and motivational counseling, on top of usual care with~     or without personalized web-based visualization of cardiovascular risk levels, improves the~     medication adherence in high risk cardiovascular patients.~   "
122708|NCT01449682|"~     To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular~     function and recalcitrant macular edema associated with retinal vein occlusion following~     treatment with 2 or more prior intravitreal anti-VEGF drug injections.~   "
122709|NCT01449669|"~     The purpose of this study is to investigate the pharmacokinetics of cefazolin using both~     plasma and microdialysate sampling methods in children with single ventricle physiology~     undergoing their second palliation procedure. This will provide data to determine if the~     current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue~     concentrations greater than the minimum inhibitory concentrations (MIC) for common~     post-surgical pathogens that cause Surgical Site Infections (SSIs).~   "
122710|NCT01449656|"~     The aim of this randomized prospective study is to compare two laryngeal mask airways with a~     provision for evacuation of gastric contents, the LMA Proseal and The investigators~     hypothesize that airway leak pressures with the LMA Proseal will be significantly different~     (higher) when compared with the LMA Supreme.~   "
122711|NCT01449643|"~     The purpose of this study is whether an inspiratory muscle training protocol would be~     associated with an improvement in of the diaphragm mobility, an increase in pulmonary~     function values , gain strength and endurance of respiratory muscles and improving quality~     of life.~   "
122712|NCT01449630|"~     This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to~     look at safety, how well the study drug is tolerated, and how much of the study drug gets~     into the blood stream and how long it takes the body to get rid of it when given to humans.~     Information about any side effects that may occur will also be collected. Subjects will~     participate in the study for approximately 3 months. This study is for research purposes~     only and is not intended to treat any medical condition.~   "
122713|NCT01449617|"~     A carotid stenosis is treated with invasive procedures of revascularization when the lumen~     is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who~     have had symptoms attributable to the affected carotid district in last the 6 months.~      Two options for the treatment of patients with carotid stenosis exist currently: the~     traditional surgical intervention of removal of the plaque by carotid endoarterectomy~     (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the~     positioning of a stent through a catheter brought directly in the carotid artery (CAS).~      The main complication of both the procedures is early thrombosis, a phenomenon in which~     platelets play a central role. The importance of an effective inhibition of platelet~     activation in these patients has been widely demonstrated.~      Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment~     for the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus~     clopidogrel, as compared with the single drugs. Given that no specific clinical trial has~     assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from~     these findings in ischemic heart disease CAS patients are treated with aspirin plus~     clopidogrel.~      Several studies have demonstrated that an elevated residual platelet reactivity despite~     treatment with clopidogrel is associated to an increased risk of major adverse~     cardiovascular events (MACE) after stenting for coronary disease.~      No data are instead available on the possible predictive value of residual platelet~     reactivity for the incidence of ischemic cardiovascular events in patients with~     atherosclerotic carotid disease undergoing CAS with stenting.~      Aim of the study will be to assess the predictive value of residual platelet reactivity, as~     measured by different laboratory tests in patients undergoing CAS with stenting and treated~     with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major~     adverse ischemic events).~   "
122714|NCT01449604|"~     The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and~     stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).~   "
122715|NCT01449591|"~     This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of~     treatment as compared to an active control and vehicle in patients with~     erythemato-telangiectatic rosacea.~   "
122716|NCT01449578|"~     This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single~     doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID~     dexpramipexole in healthy volunteers.~   "
122717|NCT01449565|"~     Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy~     in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown~     promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently~     amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work~     to determine whether monthly intramuscular injections of naltrexone will reduce~     methamphetamine (meth) use among actively using, meth-dependent men who have sex with men~     (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus~     placebo. The investigators will focus on MSM because of the disproportionate and~     intertwining epidemics of meth use and HIV in this population.~   "
122718|NCT01449552|"~     Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion~     carries substantial risk of immunologic reaction and disease transmission. Several methods~     reportedly reduce postoperative blood loss and avoid homologous blood transfusion with~     traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic~     acid administration was the recently adjuvant method to reduce blood loss in TKA. However,~     there were several regimens in either drain clamping or tranexamic acid administration~     reported in previous studies. Our objective was to compare the efficacy of our drain~     clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in~     TKA.~   "
122719|NCT01449539|"~     The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen~     therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell~     transplant.~   "
122720|NCT01449526|"~     The objective of this study is to evaluate the safety and efficacy of a new silicone~     hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by~     adapted soft contact lens wearers.~   "
122721|NCT01449513|"~     This trial will be conducted to explore the biological effects in the skin following~     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by~     reflectance confocal microscopy.~   "
122722|NCT01449500|"~     To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors~     can eradicate H. pylori in humans in the absence of antibiotics.~   "
122723|NCT01449487|"~     Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic~     abdominal pain and altered bowel habits in the absence of any organic cause. Patients with~     IBS visit the doctor more frequently, use more diagnostic tests, consume more medications,~     miss more workdays, and consume more overall direct costs than patients without IBS. More~     specific treatment of the localized symptoms of IBS is therefore needed, why the present~     study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical~     entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is~     a potent low molecular weight inhibitor for this class of ion channels described to date.~      It is hypothesized that safety, efficacy and mechanisms of local administration in the~     rectum of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the~     rectum.~   "
122724|NCT01449474|"~     Total knee arthroplasty (TKA) is the common and effective procedure for treatment of~     end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important~     factors which effects on survival of prosthesis. High percentage of misalignment has been~     reported in conventional technique with using the jig based instruments. Several methods and~     devices were established to solve this problem. Customized or patient matched instruments~     were the novel technology that made from magnetic resonance imaging (MRI) of lower limb.~     With using special software to calculate the alignment axis, it was thought that accurate~     alignment can be achieved by using this instruments. Therefore, the study aimed to compare~     the accuracy of MRI based patient matched instruments and jig based instruments in TKA.~   "
122725|NCT01449461|"~     The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to~     determine the safety profile of orally administered AP26113, including: the maximum~     tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and~     pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will~     assess the preliminary anti-tumor activity of AP26113, both in non-small cell lung cancer~     (NSCLC) with ALK gene rearrangement (including patients with active brain metastases)or~     mutated EGFR, and in other cancers with abnormal targets against which AP26113 is active.~     Approximately 135 to 175 patients will be enrolled.~   "
122736|NCT01449318|"~     The purpose of the study is to prove that pain scores generated from painful stimuli applied~     preoperatively may help identify the inter-individual variability in pain perception.~   "
122737|NCT01449305|"~     To evaluate the mean change in menstrual pain intensity during menstrual cycles from~     baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea~   "
122739|NCT01449279|"~     This study hopes to determine the effect of a combination of docetaxel, cisplatin, and~     cetuximab in weekly treatment of squamous cell carcinoma of the head and neck. The study~     would like to determine if giving the combination of these drugs at lower, more frequent~     doses will result in less severe side effects and be an effective anti-cancer treatment.~   "
122740|NCT01449266|"~     To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients~     with chronic renal failure who require hemodialysis treatment.~   "
122741|NCT01449253|"~     This is an open label, randomized, interventional study indented to find the efficacy of~     different treatment regimens in treatment of pulmonary hypertension secondary to lung~     disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil~     plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or~     hypoxia.~   "
122742|NCT01449240|"~     The purpose of the study is to collect data on CSF biomarkers in patients with Hunter~     Syndrome that would serve as reference data for comparison with cognitively impaired~     patients with Hunter syndrome, patients with other lysosomal storage diseases, or other~     diseases with CNS involvement.~   "
122743|NCT01449227|"~     The purpose of this prospective study is to see the natural course of adhesive capsulitis of~     hip. The study is based on the hypothesis that the natural course of adhesive capsulitis of~     hip is similar to that of adhesive capsulitis of shoulder. This study is also based on a~     hypothesis that hip joint capsule stretching exercise will result in pain relief, recovery~     of hip range of motion in months.~   "
122744|NCT01449214|"~     Thoracic epidural analgesia and anesthesia are effective in improving the quality of~     intraoperative and postoperative pain relief during thoracic and abdominal surgical~     procedures. Conventional epidural techniques have significant limitations. Due to the~     anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the~     insertion requires a more technically challenging paramedian approach. The safety and~     feasibility of bedside ultrasonography for the lumbar spine has already been established and~     it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia~   "
122745|NCT01449201|"~     Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor~     efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based~     irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50~     values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus~     2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II~     trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and~     preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The~     investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with~     recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.~   "
122746|NCT01449188|"~     Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea~     and vomiting. This study, called a thorough QT study, will characterize the effects of a~     single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to~     placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT~     prolongation, will be used as a positive control and will be given orally. The cardiac~     repolarization will be measured by taking consecutive ECGs on a recording device known as a~     Holter monitor and measuring the QT interval at specified times. In addition, blood samples~     will also be taken at specified times and will be used to measure the amount of study~     medication in the body.~   "
122747|NCT01449175|"~     The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long~     term safety and efficacy information about the AeriSeal System treatment in patients with~     advanced emphysema.~   "
122748|NCT01449162|"~     The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day~     versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral~     corticosteroids.~   "
122749|NCT01449149|"~     The objectives of this study are 1) To evaluate the feasibility and acute side effects of~     proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and~     long term side effects of proton beam radiation for treatment of chordomas and~     chondrosarcomas.~   "
122750|NCT01449136|"~     Dental materials with antibacterial properties can prevent the harmful effects caused by~     oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the~     performance of antibacterial cement for sealing infected dentin in atraumatic restorations~     of primary molars.~   "
122751|NCT01449123|"~     The primary objective in this pilot study is to explore if asthma patients prescribed fixed~     dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®),~     beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge~     test and the following reversibility test.~      The primary endpoint is to identify asthma patients responding positive or negative to the~     mannitol challenge test and/or the reversibility test.~      The hypothesis is that not all patients are well treated.~   "
122752|NCT01449110|"~     Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the~     cardioprotective role of resveratrol as part of the human diet is not yet clear.~      The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape~     extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention.~      All the patients are gold-standard medicated (statins and others). A number of~     cardiovascular risk and safety markers will be evaluated after consuming 1 cap/day for 6~     months and 2 caps/day for 6 additional months (total 12 months).~   "
122753|NCT01449097|"~     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus~     the femoral nerve block versus placebo on muscle strength in healthy volunteers. The~     investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of~     the quadriceps muscle strength compared to the femoral nerve block.~   "
122754|NCT01449084|"~     Temporary pancreatic duct stent placement during endoscopic retrograde~     cholangiopancreatography (ERCP) has been recommended for post-endoscopic pancreatitis (PEP)~     prophylaxis in high risk patients, including those in whom accidental pancreatic duct~     cannulation has occurred. However, the optimal duration of stent placement remains an open~     question. The investigators aim is to assess if immediate stent removal is effective in the~     prevention of PEP after accidental pancreatic duct cannulation.~   "
122756|NCT01449058|"~     This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum~     tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally~     administered combination of BYL719 and MEK162. This combination will be explored in adult~     patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or~     other advanced solid tumors and in adult patients with AML or high risk and very high risk~     MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian~     logistic regression model with overdose control. At MTD or RDE, four expansion arms will be~     opened in order to further assess the safety and preliminary activity of the combination of~     BYL719 and MEK162 in specific patient populations.~   "
122757|NCT01449045|"~     Malaria is a major public health problem. 250 million cases annually leads to approximately~     1 million deaths. Over 80 per cent of these deaths occur among African children under age~     five. The main interventions covered treatment with Artemisinin Combination Therapies (ACT),~     long lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria~     diagnosis. This has led in Senegal to a substantial decrease in the incidence of malaria, in~     2009. However the recent overall decline hides the fact that malaria incidence remains very~     high in the south of Senegal. That's why Home-based management (HMM) for malaria is being~     introduced in selected areas. Intermittent Preventive Treatment (IPT) by monthly~     administration of a therapeutic dose of antimalarials can achieve a very high degree of~     protection from attacks of clinical malaria in children. The purpose of this project is to~     evaluate the effectiveness of combining IPTc with HMM in southern Senegal~      The study objectives are to :~        -  Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in~          areas with a longer transmission season,~        -  Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine +~          Amodiaquine can offer in populations where a rapid and early care with home management~          of malaria is already established.~        -  Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized~          controlled trial has been designed to evaluate the effectiveness of adding seasonal~          IPTc with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in~          villages where home-based management of malaria is implemented. All villages in Saraya~          district, excluding 7 villages with a health post, will be eligible to participate.~          Saraya villages will be combined to form 24 clusters which will be randomized to~          receive HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community~          Medicine Distributors (CMD) will provide HMM. The primary endpoint will be the~          incidence of clinical malaria with fever or history of fever and parasitaemia with~          density of at least 3000/ul. Secondary outcomes will include the safety, the~          tolerability, the coverage and acceptability of the intervention. Both the recurrent~          and capital costs to the health service of training staff and delivering the~          interventions will be estimated. Both direct and indirect costs to users of the~          services (children and their families) will also be assessed.~   "
122758|NCT01449032|"~     Coronary artery disease (CAD) is the most common cause of death and a major cause of~     hospital admissions for acute chest pain. In spite of improved treatments still many~     patients with CAD have daily attacks of severe chest pain and severely reduced life quality.~      The investigators have established a double-blind placebo-controlled trial in patients with~     CAD to test efficacy and safety of treatment with adipose derived stem cells to improve~     perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.~   "
122759|NCT01449019|"~     The purpose of the study is to determine the contribution of endogenous Glucagon-like~     peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin~     effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).~   "
122760|NCT01449006|"~     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy~     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease;~     leading to varying degrees of cognitive impairment, recently termed HIV associated~     neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in~     both blood and CSF.~      Patients with HIV Associated Neurocognitive Disorders (HAND) who are virally suppressed in~     both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral~     therapy (HAART) regimen may have significant cognitive improvement with HAART~     intensification with the medication Maraviroc; compared to those who remain on their~     existing regimen.~      This study will be a prospective, interventional, randomised and unblinded controlled~     clinical trial. The aim of this study will be to determine whether HAART intensification~     with the medication Maraviroc, leads to significant improvement in HIV associated~     neurocognitive disorders (HAND).~      Patients with the recent progression (within 6 months) of HAND (validated by~     neuropsychological assessment) on HAART, who are virally suppressed (<50 copies per ml) in~     blood and CSF will be randomised to have their existing HAART regimen intensified with~     Maraviroc, or not. The control arm will remain on their medication regimen as prescribed.~     The target is to enrol 70 patients into the control group, and 70 patients into the~     Maraviroc intensification group.~      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and~     cerebrospinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the~     effectiveness of adding Maraviroc, will include further neuropsychological assessment at 6~     months, and neuropsychological assessment, MRI and CSF assessment again at 12 months.~      Neuropsychological testing completed at 6 and 12 months will be completed by a blind~     assessor, in that they will have no knowledge of which arm (treatment or control) the~     participant is enrolled in.~      An evaluation (neuropsychological testing) will be performed should the patient deteriorate~     during the course of the study, as recognised by the patient's managing physician.~      At the end of the study protocol (12 months) the patient's HAART therapy will be managed by~     their primary physician.~   "
122761|NCT01448993|"~     Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently~     found to suffer from oesophageal hypomotility (weak contractions).~      Oesophageal motility is currently measured using high-resolution manometry (HRM). This~     technique has a 36 pressure sensors on a plastic tube to record the pressure in side the~     oesophagus.~      Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use~     of prokinetics in patients with oesophageal hypomotility led to disappointing results. An~     explanation for these disappointing results is that inappropriate patients were targeted.~     The appropriate patient would be the one who still have some viable muscle in the oesophagus~     that can respond to pharmacological stimuli.~      In the process of developing treatment strategies in patients with oesophageal hypomotility,~     testing the preserved capacity of oesophageal muscles could be useful to predict the~     response of these patients to prokinetic drugs. The following tests have the potential to~     reveal the preserved capacity of the oesophageal muscle to respond to stronger/medicinal~     stimuli.~        1. - Multiple rapid swallowing (MRS) of 5ml water boluses stimulates oesophagus. A normal~          response to MRS requires on the one hand integrity of neural mechanisms and on the~          other hand a functional oesophageal muscle.~        2. - External abdominal compression can increase the resistance to bolus transport via~          oesophagus. The normal oesophagus produces contractions of higher amplitude and~          duration in order to maintain a normal bolus transit.~        3. - Swallowing bread boluses require stronger oesophageal contractions for a successful~          bolus transit.~      The purpose of the proposed project is to firstly assess the effect of Azithromycin on~     oesophageal hypomotility and secondly to evaluate the predictive values of the stimulation~     techniques in predicting the likelihood the positive response to drug therapy.~   "
122762|NCT01448980|"~     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death~     and affects health care system in our country. One of the most important consequences of~     stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive~     reflex to stimuli. It can cause contracture, limit self care function, transfer or~     ambulation. Most of stroke patients have to depend on their relatives or families.~   "
122763|NCT01448954|"~     This study is to examine the safety, tolerability, pharmacokinetics and functional activity~     of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic~     asthma.~   "
122764|NCT01448941|"~     The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular~     bridge plate fixation of the same joint in acute Lisfranc injuries.~   "
122765|NCT01448928|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Zevalin for relapsed or~     refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The~     objective of this study is to assess safety and efficacy of using Zevalin in clinical~     practice. This study is also all case investigation of which the enrollment period is five~     years, and all patients who received Zevalin will be recruited and followed 13 weeks after~     the administration.~   "
122766|NCT01448915|"~     The principal goal of this research project is to evaluate the extent of HCV disease and its~     treatment in coinfected IDUs. Research procedures will focus on determining liver disease~     prevalence and grade of disease within this population. The investigators will also evaluate~     if behavioral reinforcement interventions increase the rate of treatment participation and~     completion.~   "
122767|NCT01448902|"~     The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to~     placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a~     randomised, double blind, placebo controlled, two way crossover evaluation. There will be a~     screening period of up to three weeks and a washout period of at least one week between the~     two treatment periods. There will be a follow up one to three weeks after the last dose of~     study drug.~   "
122768|NCT01448889|"~     Acute renal failure induced by radiographic contrast agents is a known complication of~     coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced~     nephropathy.~      The aim of the current study is to investigate the effect of normobaric hyperoxygenation~     therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.~      The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD~     equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary~     angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated~     congestive heart failure, hemodynamic instability, known sensitivity to contrast media and~     patients who had been exposed to contrast media during the last 3 months will be excluded.~     Patients with oxygen blood saturation of less than 94% at room air will also be excluded~     from the study.~      Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask~     (treated group) or breath room air (control group) for duration of 4 hours starting at the~     beginning of the angiographic procedure.~      All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed~     using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany).~      All patients will be hospitalized 1 day before and at least 24 hours following angiography.~     Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48~     hours after coronary angiography. Urine sample will be taken 24 hours before angiography and~     6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to~     Isoprostanes and NO will be evaluated.~   "
122769|NCT01448876|"~     Objective was to understand the dynamics of Chlamydia trachomatis (Ct) detection by nucleic~     acid amplification testing (NAAT) after treatment and consequences for test-of-cure~     practice.~   "
122770|NCT01448863|"~     The present study aims to elucidate if there is a metabolomic profile alteration in the~     embryos of obese women in order to understand if the reduced implantation rate observed in~     these patients is directly related to this factor. Furthermore, the investigators seek to~     establish if there is any difference between obese women with Polycystic Ovary Syndrome~     (PCO) and without PCO. The investigators compare these metabolomic profile embryos with~     embryos of egg-donation programme.~   "
122771|NCT01448850|"~     The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or~     severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult~     subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic~     Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the~     underlying disease condition.~   "
122772|NCT01448837|"~     The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to~     compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed~     combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan)~     administered once in the evening (20:00) in newly-diagnosed patients with exfoliation~     syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated~     and IOP greater than 29 mm Hg.~   "
122773|NCT01448824|"~     This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy~     subjects of increasing daily doses of LY2484595 for 14 days to achieve a blood level of~     LY2484595 much higher than what is needed for therapy. The amount of study drug that reaches~     the bloodstream and the time it takes for the body to get rid of it will be determined. The~     effect of the study drug on factors in the blood related to cholesterol will be measured.~      Part 2 is to determine how ketoconazole affects how much of the study drug, LY2484595, gets~     into the bloodstream and how long it takes to get rid of it.~      Information about any side effects that may occur will also be collected.~   "
122774|NCT01448811|"~     To compare the difference of sedation monitoring for bronchoscopic examination monitoring by~     auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated~     patients.~   "
122775|NCT01448798|"~     The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix~     during athermal nerve-sparing prostate resection compared to conventional hemostasis using~     electrocautery in patients with localized prostate cancer and to investigate effects on~     postoperative erectile function and continence.~   "
122776|NCT01448785|"~     The main objective of this post-market surveillance study is to compare the subject's weight~     loss and quality of life, and device safety performance of the abiliti System and the~     adjustable gastric banding therapies in obese to morbidly obese subjects.~   "
122777|NCT01448772|"~     This is a comparative study to assess bioavailability of a proposed alternate dosage form~     against the current FDA-approved branded product.~   "
122778|NCT01448759|"~     The purpose of this study is to evaluate plasma alcohol concentration in patients receiving~     Paclitaxel or Docetaxel infusion.~   "
122779|NCT01448746|"~     This study is to define the optimal method of prophylaxis for patients with gastrectomy in~     Korea and the investigators hypothesized only mechanical method would be enough for~     preventing VTE on perioperative period.~   "
122780|NCT01448733|"~     The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the~     morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and~     effective for the treatment of acne vulgaris.~   "
122781|NCT01448720|"~     The purpose of this study is to explore the efficacy of paliperidone palmitate administered~     as a once monthly injection in patients with an acute exacerbation of schizophrenia.~   "
123092|NCT01444521|"~     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy~     with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal~     dosage of combination chemotherapy.~   "
122782|NCT01448707|"~     The purpose of this study is to compare the efficacy, safety and tolerability of~     darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing~     darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors~     (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who~     have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral~     Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function~     will be compared throughout the study.~   "
122783|NCT01448694|"~     This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to~     apply feature extraction and machine learning techniques to non-invasive hemodynamic data to~     identify early signs of acute blood loss. The availability of this information may help to~     establish required interventions for treating trauma patients and battlefield casualties.~      Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation~     process can be modeled to provide early estimations of blood loss.~   "
122784|NCT01448681|"~     There is statistically significant correlation between invasive measures of intracranial~     pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms~     to predict ICP. Furthermore, characteristics within this physiologic waveform data will~     allow modeling for trend prediction of derived ICP information. Specific aims:~        1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic~          brain injury in humans.~        2. Predict and anticipate changes in ICP for preemptive management purposes.~        3. Analyze characteristics of changes in ICP after treatment failure.~        4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and~          its treatment.~        5. Test the resulting models in real time.~   "
122785|NCT01448668|"~     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu~     (quercus, i.e. from oak tree) in patients with pancreatic cancer (Union for International~     Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-,~     chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.~      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of~     therapy or disease induced symptoms (both are quality of life parameters and evaluated after~     1 year); prolongation of disease free and/or overall survival (DFS, OS) after 3 years.~      Prospective observational confirmation study of previous retrospective cohort study.~      As this is a non-interventional cohort study, all therapies and measurements are performed~     on directive by the treating physician and/or request by the patient only.~   "
122786|NCT01448655|"~     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu~     (quercus, i.e. from oak tree) in patients with colorectal cancer (Union for International~     Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological~     therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional~     therapy only.~      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of~     therapy or disease induced symptoms (both are quality of life parameters and evaluated after~     1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years.~      Prospective observational confirmation study of previous retrospective cohort study.~      As this is a non-interventional cohort study, all therapies and measurements are performed~     on directive by the treating physician and/or request by the patient only.~   "
122787|NCT01448642|"~     The purpose of this study is to determine whether a loading dose of atorvastatin before~     percutaneous intervention procedures in acute coronary syndromes is effective to reduce~     major cardiovascular events(MACE).~   "
122788|NCT01448629|"~     Introduction:~      It is not an illness to have an ostomy, even though it is an indication of previous serious~     illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.~     Ostomies can be divided into three categories: colostomy (large intestine), ileostomy (small~     intestine) and urostomy (urinary tract). All require surgical redirection of the intestine~     or urinary tract, allowing for elimination of urine and faeces by means of an opening in the~     abdominal wall. For the population included in this study, subject with an ileostomy,~     colitis ulcerosa is the main cause for an ileostomy where a surgical removal of the colon~     and rectum resulting in an ileostomy in theory cures the disease.~      It can be very challenging to live with an ostomy and modern ostomy products should make~     life as easy as possible for people with ostomies.~      Leakage and peristomal skin problems have been found to have a negative effect on the~     quality of life for people with ostomies. The skin problems are the reason for one out of~     three visits to ostomy nurses and occur much more frequently in people who have had~     ileostomies than in those who have had colostomies. It has been observed that the prevalence~     of peristomal skin problems is 21-60% among people who have ileostomies, 13-35% among those~     who have colostomies and 21-48% among those who have urostomies.~      Leakage from ostomies that comes into contact with the skin is thought to predispose the~     patient to peristomal skin problems. One investigation of peristomal skin problems found~     that 77% of cases were related to contact with faeces or urine.~      There are several reasons why leakage from an ostomy occurs, such as uneven peristomal area,~     improper handling of the ostomy product or a problematic ostomy (its formation, its~     location, retraction, prolapse or hernia). The ostomy may also change size with time, which~     can lead to leakage, if the ostomy products are not adapted accordingly. As a general rule,~     a check-up of the ostomy by an ostomy nurse or a doctor together with educational support~     can reduce these problems. Modern ostomy products should, however, also be constantly~     developed in order to lessen to the greatest extent possible the risk of leakage and~     associated inconveniences.~   "
122789|NCT01448616|"~     The investigators propose a randomized, double blind, placebo-controlled, cross-over trial~     to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex~     virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human~     immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that~     tenofovir will reduce genital HSV shedding compared to placebo.~   "
122790|NCT01448603|"~     Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August.~     In the third National Health and Nutrition Examination Surveys54.3% of the population had~     positive test responses to one or more allergens, with the prevalence for short ragweed~     being 26.2%~      The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis~     symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing~     visits and the post treatment challenge (PTC) visit in study TR002 approximately one year~     after the start of treatment.~   "
122791|NCT01448590|"~     Epidural anesthesia is associated with potential risks and complications, post dural~     puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia.~     Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies~     have suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A~     systematic review of the existing literature will identify if there is reliable evidence to~     support this theory. A secondary outcome, headache severity, will also be explored via~     incidence rates of epidural blood patch, as this intervention is performed as a treatment~     for the most severe headaches.~   "
122792|NCT01448577|"~     Lipoprotein lipase deficiency (LPLD) is an autosomal recessive inherited condition caused by~     homozygosity or compound heterozygosity for mutations within the LPL gene. LPLD results in~     subjects presenting with fasting plasma triglyceride (TG) levels of > 10 mmol/l. LPLD~     typically presents in infancy or childhood with usual complaints of severe abdominal pain,~     repetitive colicky pains and repeated episodes of acute pancreatitis The most severe~     clinical complication associated with LPLD is acute pancreatitis. Pancreatitis in an LPLD~     subject often leads to prolonged hospital admissions (sometimes up to weeks). Subjects who~     survive repeated episodes of acute pancreatitis may develop chronic pancreatitis, ultimately~     resulting in endocrine and exocrine pancreatic insufficiency.~      The clinical manifestations of acute pancreatitis episodes related to LPLD are largely~     indistinguishable from acute pancreatitis due to other causes. However, collection of data~     relating to hospital admissions, laboratory test results, scan images and adverse events~     occurring concomitantly to the acute pancreatic episode should allow elimination of other~     causes of pancreatitis (e.g gallstones etc) and ultimately allow confirmation of~     LPLD-related acute pancreatitis. Characterization of the presentation of symptoms which~     occur around the time of known episodes of LPLD-related acute pancreatitis should also~     permit identification of episodes of acute pancreatitis which have previously been~     considered as unrelated or even unrecognized.~      The objective of the study is to re-assess and re-confirm data previously recorded about the~     incidence and severity of acute abdominal pancreatitis episodes in LPLD subjects~     previously enrolled on AMT clinical studies. To assess and document the presentation of~     acute abdominal episodes that occur around known episodes of pancreatitis and to permit the~     identification of possible new previously unrecorded episodes of pancreatitis based upon~     predefined diagnostic criteria. The objective is to recruit the 27 subjects previously~     enrolled in the above mentioned clinical studies.~   "
122793|NCT01448564|"~     Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and~     healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible~     to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs~     on muscle function, exercise capacity, and cardiorespiratory responses during isometric and~     dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to~     severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted~     in two visits each, for a total of four visits a week a part. First, a venous blood sample~     will be taken from the patients. The isometric protocol will start with the determination of~     the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC)~     for the isometric endurance test (IET). Patients will be randomized to receive either the~     placebo or LED application. Immediately after finishing this procedure, the patients will~     carry out the IET until the limit of tolerance or until a 20% fall of strength is observed.~     After the test, another blood sample will be taken. In the other visit (one week later), the~     same order of procedures will be performed, except with the opposite (LED or placebo). For~     the dynamic protocol, the same procedures described above will be followed except with the~     maximal incremental cycle ergometer test used instead of the IET. The electromyography will~     be recorded during the isometric and dynamic protocols. Differences in muscle function,~     exercise capacity, and cardiorespiratory responses between the LED and placebo applications~     will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients~     with COPD by increasing exercise tolerance.~   "
122794|NCT01448551|"~     Obesity affects millions of American children and increases their risk of adult obesity, a~     myriad of serious illnesses, increased healthcare costs, and premature death. It is vital to~     find ways to reverse this epidemic. Multidisciplinary behavioral weight management programs~     offer the promise of effectively treating childhood obesity. However, participants in such~     programs often find it challenging to follow recommended treatment plans and frequently drop~     out from programs without completing them. The proposed project aims to address these~     problems through frequent contact with patients between office visits. This interim contact~     will be achieved by automatically sending tailored messages to the mobile phones of~     adolescents enrolled in a multidisciplinary weight management program (the MPOWER program),~     as an adjunct to clinic visits.~      The investigators hypothesize that program participants who receive the tailored text~     messages will experience lower attrition rates, increased treatment adherence, and greater~     weight loss compared to those program participants who do not receive the messages.~   "
122795|NCT01448538|"~     In the research study an observation of patients with wet age-related macular degeneration~     (wet AMD) will be performed.~      The term observational study indicates that the current course of therapy and the associated~     circumstances will be recorded. In this study, no medical care is changed. Also, no new~     drugs are tested.~      This study is being conducted in about 30 centers in Germany. A total of approximately 500~     patients will be enrolled. The study is designed for a period of 12 months.~      At the beginning and end of the study the physician will document the patient data.~     Therefore will be used information from the patient records and documented visits. If such~     information is not available in the study center, the otherwise attending ophthalmologist~     will be consulted about the vision acuity values and visits in the observation period.~      Furthermore, patients are asked to participate in three telephone interviews and fill out~     during their visits to the study center a short questionnaire about their current vision and~     their well-being. In the telephone interviews will be discussed with the patient about his~     wet AMD disease and its treatment, its experience and its perspectives as well as any~     problems occur.~   "
122796|NCT01448525|"~     The purpose of this study is to determine patient satisfaction with LATISSE® treatment for~     increasing eyelash prominence.~   "
122797|NCT01448512|"~     This study will evaluate the impact of combining two evidence-based interventions: a couples~     risk reduction intervention with an evidence based medication adherence intervention~     designed to enhance male participation in combination with improving medication and~     prevention of mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs).~     Clinics will be randomly assigned to experimental and control conditions and effectiveness~     of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by~     both individuals and clinics will be examined. It is hypothesized that community clinics~     implementing PartnerPlus will have more effective PMTCT program adherence, as measured by~     total participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and~     paternal human immunodeficiency virus (HIV) Counseling & Testing (HCT) uptake, 3) maternal~     and infant antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral~     therapy (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal~     and infant HIV serostatus and that community clinics implementing PartnerPlus will have~     reduced sexual risk behavior, as measured by participant sexual barrier use.~   "
122837|NCT01447992|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
122798|NCT01448499|"~     Background: schizophrenia is a debilitating mental disorder affecting about 1% of the~     general population. About 30% of patients will not react to current drug treatment and~     defined as treatment-resistant schizophrenia patients (TRSP). The best studied therapeutic~     option for this population is clozapine therapy. Clozapine was shown to be effective than~     any other antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not~     demonstrated to be more effective than clozapine monotherapy. Albeit Clozapine superiority~     in TRSP, its use may be involved with many adverse effects, some of them are~     life-threatening, and need for routine blood tests. Amisulpride is an atypical antipsychotic~     drug with a different mechanism of action than clozapine, with less adverse effects. No~     study compared directly amisulpride and clozapine in TRSP.~      Study objective: to compare, for the first time, the broad clinical effectiveness of~     clozapine and amisulpride and their combination in TRSP.~      Study Design: a clinical, prospective, naturalistic, randomized, comparative study~     simulating a real-world approach of clinical decision making.~      Methods: a total of 140 TRSP will be recruited from a large regional mental health center.~     Participants will be randomized into two treatment groups (70 in each group): clozapine~     monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks~     of treatment. In case of treatment failure (insufficient clinical response or severe adverse~     effect) participants will be offered either to switch to clozapine treatment (for failed~     amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine~     monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment~     will be made using clinician rated scales and self-completed questionnaires, rating the~     broad phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive,~     cognitive and quality of life) and drug-related adverse effects (objective and subjective).~      Analysis: comparison of the effectiveness of the three treatment groups: amisulpride,~     clozapine and their combination, in the various dimensions of TRSP.~   "
122799|NCT01448486|"~     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy~     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease~     leading to varying degrees of cognitive impairment, recently termed HIV associated~     neurocognitive disorders (HAND).~      HAND may occur in patients who are virally suppressed in both blood and CSF. Patients with~     HIV Associated Neurological Disorders (HAND) who are virally suppressed in both their blood~     and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART)~     regimen may have significant cognitive improvement with HAART intensification with the~     medication Raltegravir; compared to those who remain on their existing regimen.~      This study will be a prospective, interventional, randomised and unblinded controlled~     clinical trial. The aim of this study will be to determine whether HAART intensification~     with the medication Raltegravir, leads to significant improvement in HIV associated~     neurological disorders (HAND).~      Patients with the recent progression (within 6 months) of HAND (validated by~     neuropsychological assessment) on HAART who are virally suppressed (<50 copies per ml) in~     blood and CSF will be randomised to have their existing HAART regimen intensified with~     raltegravir 400mg twice daily, or not. The control arm will remain on their medication~     regimen as prescribed. The target is to enrol 110 patients into the control group, and 110~     patients into the Raltegravir intensification group.~      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebral~     spinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the~     effectiveness of adding Raltegravir, will include further neuropsychological testing at 6~     months; and neuropsychological testing, MRI and CSF assessment at 12 months.~     Neuropsychological testing completed at 6 and 12 months will be completed by a blind~     assessor, in that they will have no knowledge of which arm (treatment or control) the~     participant is enrolled in.~      An evaluation (neuropsychological testing) will be performed should the patient deteriorate~     during the course of the study, as recognised by the patient's managing physician. The~     decision of the Antiretroviral medication regimen to be used in such a case will be~     determined by the managing physician. At the end of the study protocol (12 months) the~     patient's HAART therapy will be managed by their primary physician.~   "
122800|NCT01448473|"~     Minor head injuries are a common presenting complaint in the pediatric emergency department.~     Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of~     minor head trauma. However, there exists ongoing controversy regarding the ideal number of~     views that should be obtained in a skull series. This study aims to determine if there is a~     significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of~     fracture in paediatric minor head trauma patients when a 2-film series as opposed to a~     4-film series is provided to participating pediatric emergency physicians.~   "
122801|NCT01448460|"~     Vitrification is a method of cryopreserving tissue for future use. It is widely used to~     preserve extra, good quality embryos generated from infertility treatments. It is becoming~     popular for the preservation of oocytes (eggs) as well, but is still considered~     investigational in this respect. The purpose of this study is to provide egg freezing for~     patients desiring fertility preservation. Although commonly used in clinics around the~     world, it should be offered as an IRB approved study procedure until it is no longer~     considered investigational by the American Society of Reproductive Medicine.~   "
122802|NCT01448447|"~     This study will evaluate the local control rate, cosmetic results, and complication rates of~     breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of~     radiation therapy or as a boost technique for patients with stage I-II carcinoma of the~     breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically~     negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.~      Hypotheses:~        -  For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ~          (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is~          technically feasible and reproducible with acceptable complication rates.~        -  Cosmetic results after brachytherapy will be similar to that obtained after traditional~          whole breast external beam radiation therapy.~        -  Local tumor control rate in the breast after brachytherapy will be similar to that of~          conventional external beam radiation therapy, with less inconvenience and potentially~          less cost to the patient, given the selection criteria which minimize the risk of~          clinically significant multicentric or extensive residual carcinoma following~          lumpectomy.~   "
122803|NCT01448434|"~     This study is designed to know the safety and efficacy of 2 different doses of mesenchymal~     stem cells in patients suffering from osteoarthritis of knee joint.~   "
122804|NCT01448421|"~     This is a research study using the SMT Embolic Deflection Device and involving patients with~     aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic~     Valve Replacement (TAVR).~      The TAVR procedure consists in replacing the diseased aortic valve by a new artificial~     valve. The new valve is put into place using a long, thin tube called a catheter that is~     inserted into a small incision (cut) in the patient's groin and threaded through his/her~     arteries up to the heart.~      During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could~     break off from inside the arteries and travel to the brain. The embolism could be made of~     clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the~     embolism is carried through the blood to the brain, it could cause a stroke or other~     neurological (brain) problems. A stroke happens when blood flow to a part of the brain is~     blocked, causing brain cells to die.~      The SMT Embolic Deflection Device has been developed to prevent an embolism from going to~     the brain and causing a stroke or other brain damage. The device is a wire mesh filter that~     covers the vessels that carry blood to brain, deflecting any any blood clots or other~     materials away from the patient's brain and towards the lower body, where they are less~     likely to cause harm.~   "
122805|NCT01448408|"~     The present study attempts to evaluate the diagnostic capacity of a) anterior segment~     parameters b) biomechanical metrics and c) a combination model, in differentiating Forme~     Fruste Keratoconus (FFK) from healthy corneas.~      The study adhered to the tenets of the Declaration of Helsinki and written informed consent~     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),~     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing~     primarily on the conditions of the anterior segment of the eye.~      All participants underwent a complete clinical evaluation including review of medical~     history, visual acuity measurements, uncorrected and best corrected visual acuity, placido~     disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy~     and fundoscopic examination.~      All study participants were divided in two groups. The FFK group (FFKG) consisted of~     patients with unilateral KC.~      The control group (CG) was formed by refractive surgery candidates who visited EIT's~     outpatients service for their preoperative examination.~      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the~     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.~     Upon successful fixation of the patient's eye on a red blinking target, the operator~     activated the device. An air puff was released by a non-contact probe, which scanned the~     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the~     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the~     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal~     state. The system monitors the entire process and measures two pressure values, which are~     determined from the inward and outward applanation processes. The aforementioned measuring~     procedure enables the determination of CH which is related to the viscoelastic structure of~     the corneal tissue, and is calculated as the difference between the two pressure values at~     the two applanation processes, and CRF which is indicative of the overall resistance of the~     cornea and is calculated as a linear function of the two pressures associated with the two~     applanation. In order to ensure accurate results, ORA was done four times for each eye, by~     the same operator. Signals that differ significantly in appearance from the other signals~     from the same eye were deleted.~      Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm~     (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT)~     and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated~     using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and~     monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate~     together. After proper alignment of the patient's head, a fixation target is shown which~     guides the patients gaze. A real time image of the patient's eye is shown to the examiner on~     the computer screen, and the image is manually focused and centered. Acceptable maps had at~     least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central~     9.0mm zone were excluded. Regarding the measuring procedure itself, patients were asked to~     blink and then look at the fixation device. In case of low-quality image, the procedure was~     repeated until the acceptable criteria were met.~      The data from the FFKG were compared with those from the CG in separate series analyses.~     Receiver operating characteristics (ROC) curves were applied to determine the overall~     predictive accuracy of the test for each studied parameter, as described by the area under~     the curve. We also used this approach to identify the cut-off points for studied parameters~     to maximize sensitivity and specificity in discriminating FFK cases from normal corneas.~     Logistic regression was used to support the cut-off point identified in the ROC curve~     analysis. We determined a cutoff value that will gave us the best predictive fit for our~     sample data. Furthermore, logistic regression analysis was performed to determine the~     predictive capability of a model that combined both corneal biomechanical properties and~     pentacam derived anterior segment parameters.~      Differences between groups were evaluated using the Welch modified Student's two sample~     t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A~     Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level~     of significance for each parameter was set at p<0.05. The Pearson and Spearman tests were~     performed in order to assess correlations between anterior segment parameters and~     biomechanical properties, depending on their parametric evaluation.~   "
122806|NCT01448395|"~     A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body~     when given as an injection into the blood stream.~   "
122948|NCT01446549|"~     The purpose of this study is (1) to provide quantitative information of the motor~     manifestations of Parkinson's disease and (2) to quantify the effect of high intensive~     antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's~     disease.~   "
122807|NCT01448382|"~     1. Primary Scientific Objective~             -  Collect human clinical data to sustain the development of blood detection sensor~               and optimize its algorithm and parameters~             -  Preliminary evaluation of blood detection performances in human.~        2. Secondary Scientific Objective~             -  Assessment of blood detection sensor ability to identify the anatomical location~               (i.e. Stomach, SB or Colon)~             -  Evaluation of capsule transit characteristics in the GI tract~             -  Evaluation of BBC capsule safety~      Study Hypothesis:~      It is estimated that by implementing a spectrophotometer technology in capsule and utilizing~     the unique characteristics of light absorption by blood in specific spectrum, the capsule~     will be able to automatically detect blood in the GI tract with high accuracy. As such, the~     system may be an add-on to video capsules to provide efficient and quick detection of blood~     presence (for example in OGBI patients) or as stand alone low cost capsule (without video)~     which could serve as a tool similar to standard FOBT.~   "
122808|NCT01448369|"~     Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than~     half of some Asian populations), affects the lipid producing meibomian glands in the~     eyelids. One function of the glandular secretions is to reduce evaporation of the tear film.~     In MGD the meibomian glands may become blocked for various reasons. The consequential~     retention and stasis of the secretion increases immune response as well as scarring~     response. This eventually results in an abnormal tear film and dry eye symptoms.~      The current standard treatments include warm moist compresses, regular lid hygiene, oral~     antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an~     extended duration is important because it relieves the occlusion of blocked meibomian~     glands. However, improvised methods of heating are cumbersome and inefficient requiring~     repeated measures, often leading to lack of compliance. Today, there is a wider range of~     commercially available devices that help to unblock meibomian glands and relief dry eye~     symptoms. These devices may improve MGD treatment dramatically, but have not been tested in~     the warm climate of Singapore, and are not readily available.~      The current study aims to test the efficacy of treatment for devices that utilize A) warm~     moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland~     dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks.~     The study will monitor patients for changes in tear film and lipid composition, as well as~     changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be~     documented in form of questionnaires. If the newer methods of managing MGD are found to be~     efficacious and safe, these treatment measures can be made available to patients in~     Singapore.~   "
122809|NCT01448356|"~     Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden~     in Asia and the rest of the world. This is a small pilot study to evaluate tear function~     under different conditions of humidity and temperature. This data will be useful for~     designing future trials in ocular surface and dry eye. The data will likely be used to~     propose a larger national funded project involving clinical trials. This study involves~     collaboration between engineers, ocular surface clinicians as well as specialists from the~     defence science organisation. When successfully completed, the project will increase the~     capability of Singapore Eye Research Institute and Singapore National Eye Centre to support~     future industry and academic research in the ocular surface.~   "
122810|NCT01448343|"~     Rapid infusion of red blood cells is known to result in the increase of plasma potassium.~     The researchers are trying to investigate the change in plasma potassium during rapid~     infusion of mixed blood components in the reservoir of the fluid management system (FMS) in~     liver transplant recipients.~   "
122811|NCT01448330|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of clopidogrel and aspirin in free combination as HCP0911.~   "
122812|NCT01448317|"~     Primary Objective:~      To assess the safety and tolerability of ascending single doses of subcutaneously (SC)~     administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.~      Secondary Objectives:~        -  To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum~          low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such~          as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density~          lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides,~          Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).~        -  To assess the Pharmacokinetic profile of a single SC dose of alirocumab.~        -  To assess the immunogenicity of a single SC dose of alirocumab.~   "
122813|NCT01448304|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objective:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
122814|NCT01448291|"~     It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of~     inflammation.~      Hypothesis:~      The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as~     vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in~     the vagina.~      Specific aims of this study are to:~        1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations~          in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use~        2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic~          concentration before and after treatment with NuvaRing®~        3. Monitor for changes in the Nugent score before and after NuvaRing® use~        4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use~        5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use~      Methods This is a prospective, open-label, nonrandomized study. Participants will serve as~     their own controls. The Clinical Research Center of Eastern Virginia Medical School,~     Norfolk, Virginia, U.S.A. will be the only study site.~   "
122815|NCT01448278|"~     The All-inside method is a new minimally invasive procedure for anterior cruciate ligament~     reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.~     In the so-called classical method, the fixation is achieved with interference screws.~      The hypothesis of this study was that the All-inside technique causes less pain than the~     conventional technique. The main objective was to evaluate the immediate postoperative pain~     for the first ten days and at one month from the intervention.~   "
123093|NCT01444508|"~     In order to reduce bloodloss and need for transfusion to investigate the effect of colloid~     and crystalloid on coagulation assuming no difference between the groups.~   "
122816|NCT01448265|"~     Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia,~     impairs quality of life and increases stroke risk and mortality. Recent clinical experience~     with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can~     be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF,~     thereby eliminating the recurrence of AF.~      Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction~     during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential~     mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy~     times decrease with experience.~      Objective: The purpose of this study is to assess safety, feasibility, and a learning curve~     associated with cryoballoon catheter ablation using a novel circular mapping catheter~     (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with~     symptomatic paroxysmal atrial fibrillation.~      The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™~     mapping catheter. The reduction of procedure and fluoroscopy times during the first 40~     patients treated with this approach will be analyzed to evaluate a potential learning curve~     upon introduction of the technique.~   "
122817|NCT01448252|"~     This is a double blind phase I-II clinical trial with multiple autologous T cell~     vaccinations using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP,~     in patients with relapsing progressive Multiple Sclerosis.~   "
122818|NCT01448239|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objectives:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
122819|NCT01448226|"~     Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in~     patients (pts) with hematologic malignancies. As culture-based methods only yield results in~     a minority of patients, using non-culture-based methods for detection of aspergillosis in~     clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL)~     samples with polymerase chain reaction (PCR) is promising, however, the influence of current~     antifungal drugs on the performance of this diagnostic tool remains controversial.~      The aim of the trial is to elucidate on the performance of BAL PCR under antifungal~     treatment.~   "
122820|NCT01448213|"~     The purpose of this study is to compare two different commonly used steroid dosing regimens~     after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The~     investigators hope to determine if one is more effective at preventing rejection or if both~     are equally effective.~   "
122821|NCT01448200|"~     PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a~     potential treatment for hepatitis C virus infection. This study is being done to assess the~     safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of~     the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study~     will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of~     PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels)~     also will be assessed.~   "
122822|NCT01448187|"~     The aim of the study is to describe the characteristics of patients treated with Iressa~     (particularly age, gender, phenotype, histology and stage of disease, line of treatment and~     previous treatments, smoking history, conditions of initiation of treatment (presence of an~     EGFR-activating mutation) and to evaluate the impact of treatment on the health of the~     population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and~     quality of life~   "
122823|NCT01448174|"~     Hyperlipidemia and atherosclerosis lead to cardiovascular diseases and are an indirect cause~     of increased death rate in the general population. This association is still more evident in~     specific subpopulations, like patients with advanced chronic kidney disease (CKD),~     especially hemodialysis (HD) patients, due to a higher prevalence of lipid disturbances and~     atherosclerosis compared to the general population. Cardiovascular events in CKD patients~     are frequently associated with traditional risk factors, including diabetes, male sex,~     hypertension, dyslipidemia and advanced age. However, these factors failed to fully account~     for the increased risk of cardiovascular events in CKD. The efforts are made to identify new~     risk factors that contribute to the development of atherosclerosis and participate in causes~     of cardiovascular death. In 2003, there were identified peptides designated salusin-alpha~     and salusin-beta. Development of atherosclerosis may be suppressed by salusin-alpha.~     Salusin-alpha may have a lipid lowering effect, similar to that of statins.~      The purpose of this study is to investigate whether 1) salusin-alpha is associated with~     lipid metabolism of HD patients (without or with metabolic syndrome or type 2 diabetes~     mellitus), similarly or not like in healthy or obese subjects; 2) treatment with~     atorvastatin and its effects are associated with changes in plasma salusin-alpha~     concentration, if so - whether it is dependent on the direct influence of atorvastatin on~     salusin-alpha or associated with a decrease in serum lipid level; 3) salusin-alpha may~     predict mortality in HD patients.~   "
122824|NCT01448161|"~     Study hypothesis: Machine Learning algorithms and techniques previously developed for use in~     the robotics field can be applied to the field of medicine. These state-of-the-art, feature~     extraction and machine learning techniques can utilize patient vital sign data from bedside~     monitors to discover hidden relationships within the physiological waveforms and identify~     physiological trends or concerning conditions that are predictive of various clinical~     events. These algorithms could potentially provide preemptive alerts to clinicians of a~     developing patient problem, well before any human could detect a worrisome combination of~     events or trend in the data.~      Specific aims:~        1. Collect physiological waveform and numeric trend data from patient vital signs monitors~          in ICUs at the University of Colorado Hospital and Children's Hospital Colorado.~        2. Combine the physiological data from patient monitors with clinical data obtained from~          patient Electronic Medical Records including IV fluids, medications, ventilator~          settings, urine output, etc. for use in developing models of various clinical~          conditions.~        3. Apply Machine Learning techniques to these models to identify physiological waveform~          features and trend information, which are characteristic and predictive of common~          clinical conditions including but not limited to:~             -  Post-operative atrial fibrillation and other cardiac dysrhythmias~             -  Post-operative cardiac tamponade~             -  Tension pneumothorax~             -  Optimal post-operative and post-resuscitation fluid needs~             -  Intracranial hypertension and cerebral perfusion pressure~   "
122825|NCT01448148|"~     Memory interventions are training programs that provide a variety of cognitive and~     psychological strategies meant to improve memory. These interventions have been shown to~     yield significant benefits to normal aged persons and small-size studies have shown that~     they are suitable and beneficial for persons with mild cognitive impairment. The goal of~     this proposal is to assess with a well-controlled design the efficiency and specificity of~     cognitive training in persons with mild cognitive impairment.~      The hypothesis is that cognitive training can improve the cognition of persons with mild~     cognitive impairment and that this improvement can be enduring.~   "
122826|NCT01448135|"~     The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of~     the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish~     oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post~     surgical patients in the intensive care unit (ICU). If enough patients are recruited,~     inferences about impact on outcomes may also be drawn.~   "
122827|NCT01448122|"~     The main objective of the study is to assess the efficacy of Avène Compact Honey in~     preventing pigmentation induced by visible light in subjects with a phototype III or IV.~      Patients will be exposed to a range of visible light to areas on the back to confirm study~     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be~     eligible to continue.~      Eligible patients will have study product applied to part of the back. The back will be~     exposed to a range of light based on the minimum exposure inducing pigmentation previously~     ascertained. The area where study product is applied will have a higher range of light~     exposure than the area without the study product.~      Seven days later, the areas will be examined to determine the lowest exposure inducing~     pigmentation on the sides with and without study product. The color will also be measured~     between two identical exposures with and without the applied study product.~   "
122828|NCT01448109|"~     The purpose of this study is to find out whether adult patients admitted to the Intensive~     Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy~     solution), will have an improved rate of survival 90 days later.~      Septic shock is the result of an infection, which triggers a complex response by the body~     (the inflammatory response) that causes a decrease in blood pressure and subsequently one or~     more organ systems to fail when blood supply to these organs is reduced. This may result in~     poor recovery and death. About a quarter of the people who suffer septic shock that is not~     rapidly reversed, will die.~      When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a~     number of therapies. These include fluids given through a drip, antibiotics, drugs to boost~     your blood pressure and other organ systems.~      In addition to these therapies, steroids (hydrocortisone) are sometimes administered.~     Whether steroids are useful or not in the treatment of severe infections has been studied~     for more than 50 years. Previous research has suggested that the use of low dose steroid may~     have shortterm benefits in improving the circulation. However, there is no agreement amongst~     doctors around the world about whether treatment with or without low dose steroids improves~     the overall recovery and survival in patients with septic shock. This study would allow~     doctors to make informed decisions about whether the addition of low dose steroid therapy is~     better for patients with septic shock in intensive care.~      The study will include 3800 intensive care patients who have septic shock. Each enrolled~     patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7~     days as a continuous intravenous infusion while in intensive care. The patient will be~     followed for 90 days. If the patient is discharged prior to 90 days a telephone call will be~     made for the followup information. At six months the patient will be contacted again for~     completion of a quality of life questionnaire.~   "
122829|NCT01448096|"~     The purpose of this study is to clarify the impact of rituximab on clinical outcomes in~     patients with primary breast diffuse large B-cell lymphoma and also to investigate the role~     of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous~     system (CNS) recurrence.~   "
122830|NCT01448083|"~     The purpose of this study is to determine if the measurement (with a standard nuclear~     camera) of radioactivity normally present in the nervous system of your heart at four hours~     after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different~     than radioactivity measured in your heart at one and/or two hours after your diagnostic scan~     injection. If equivalent information to the conventional 4 hr H/M ratio could be collected~     by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient~     acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be~     considerably less time-consuming.~      One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be~     given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid~     from receiving the small amount of radiation that is a normal part of the MIBG scan. You~     will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15~     minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These~     pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner~     Medical Center-Kenner. The experimental (research) part of this study is having the extra~     10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally,~     pictures are only taken 24 hours after the injection. Therefore the research is limited to~     the four extra pictures taken, and involve no additional injections or I-123 drug beyond~     that you will be receiving regardless of whether you are part of this research.~   "
122831|NCT01448070|"~     This trial is conducted in Europe. The aim of this trial is to show that the product of the~     new production process has a similar pharmacological profile to the traditional process used~     for the current commercial product Actrapid®.~   "
122832|NCT01448057|"~     The study is a clinical evaluation of an over the counter (OTC) combination product~     containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride~     (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion,~     rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).~   "
122833|NCT01448044|"~     The purpose of this study is to compare the sustained virologic response at post treatment~     Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin~     (RBV) versus placebo/PegIFNα-2a/RBV).~   "
122834|NCT01448031|"~     This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between~     Esomeprazole and Aspirin after multiple dose administration.~   "
122835|NCT01448018|"~     The purpose of this study is to compare ranibizumab injection to hemodilution at the early~     phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both~     treatments may have a synergic effect.~   "
122836|NCT01448005|"~     This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35%~     following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that~     wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing~     arrhythmic death in this select population with high risk for sudden cardiac death (SCD).~     This is a pilot project to determine the feasibility of a larger-scale study.~   "
122838|NCT01447979|"~     A single arm, single treatment study is proposed to assess the feasibility of a portable~     artificial pancreas system outside of a hospital based clinical research center.~      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous~     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions~     (hotel).~   "
122839|NCT01447966|"~     The purpose of this research study is to further investigate how well cognitive-behavioral~     psychotherapy works to reduce obsessive-compulsive symptoms in young children with~     obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work~     well in youth with OCD and other anxiety disorders; however, there are only a few studies to~     date in preschool and young children with OCD. All children will have the option to receive~     12 twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each.~     Randomly determined, half of all children will receive these sessions immediately following~     the pre-assessment and the remaining half will receive them after six weeks. The~     investigators expect that youth receiving the study-based therapy will show more improvement~     in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.~   "
122840|NCT01447953|"~     The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability~     and facilitate return-to-work. However, there is a lack of treatment strategies that~     effectively target and affect return-to-work and reduce sickness absence, and that in~     addition are sufficiently easy and feasible to administer in primary care. A new activity~     and life-role targeting rehabilitation program (ALAR) has been developed to reduce~     psychosocial barriers to rehabilitation progress, promote re-integration into life-role~     activities and facilitate return-to-work. The program will be implemented and provided as~     one of the pain treatment modalities available through multi-professional teams in primary~     care in one Swedish county. This study aims to evaluate the effect of an activity and~     life-role targeting pain rehabilitation program on the outcome variables return-to-work and~     sickness absence.~   "
122841|NCT01447940|"~     Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine~     ePortal for sharing information between diabetologist and type 1 diabetic patient is not~     inferior to a conventional care regarding metabolic results at 12 months.~   "
122842|NCT01447927|"~     This randomized phase II trial studies how well metformin hydrochloride works in preventing~     esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain~     drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal~     cancer from forming.~   "
122843|NCT01447914|"~     This phase II trial studies the side effects and how well tivantinib works in treating~     patients with relapsed, or relapsed and refractory multiple myeloma. Tivantinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
122844|NCT01447901|"~     LPL (Lipoprotein Lipase) is an enzyme which plays an important role in the elimination of~     triglycerides (fat) and the clearance of dietary fat particles known as chylomicrons (CM) in~     the blood. In patients who have an abnormal LPL gene, the enzyme does not work (total,~     hereditary LPL deficiency), which results in a large increase in the amount of triglycerides~     (fats) and chylomicrons in the blood. This increases the risk of inflammation in the~     pancreas and leads to long term negative effects for bloods vessels (atherosclerosis).~     Current medications and / or a strict and low fat diet do not sufficiently reduce the level~     of triglycerides in order to prevent these conditions. To solve this problem, the company,~     AMT is developing a gene therapy (AMT-011).~      In normal healthy individuals, fat particles are rapidly cleared from the circulation~     following a standard meal. Within approximately 3 hours the highest levels of fat is reached~     and clearance is achieved within the subsequent 9 hours. In LPLD subjects, the clearance of~     fat is greatly reduced as a direct consequence of the lack of LPL. During this study, a~     standard meal with a tracer (3H-palmitate) is given. Since palmitate is incorporated in the~     dietary fat, this study enabled monitoring of appearance of newly formed dietary fat into-~     and clearance of these newly formed dietary fats from the circulation, over time.~      The principal aim of the study is to verify if the gene therapy (AMT 011) is still effective~     in the treatment of this condition. Systemic appearance and clearance of new formed dietary~     fat particles after ingestion of the meal will be determined by measuring the level of~     tracer at different time points.~   "
122845|NCT01447888|"~     The purpose of this study is a comparison of pain management in opioid-tolerant spine~     surgery patients using a perioperative dosing goal of 150% of patient's baseline oral~     morphine equivalent (OME), as compared to standard perioperative dosing, which does not~     currently account for patients' baseline opiate use.~   "
122846|NCT01447875|"~     Hypotension and bradycardia are often observed following induction of dexmedetomidine or~     propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of~     main causes for this hypotension.The investigators hypothesized that hypotension after~     induction of sedation is caused by decrease of preload by sedative agents,and passive leg~     raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients~     with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid~     responsiveness.~   "
122847|NCT01447862|"~     Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30~     million North Americans and Europeans by 2050. Atrial fibrillation is associated with~     increased cardiovascular morbidity and mortality, with stroke being an especially important~     and potentially devastating complication. Many studies have investigated the efficacy of~     different drugs in converting atrial fibrillation to sinus rhythm. There are numerous~     randomized controlled trials that have tested the efficacy of agents against placebo and~     some trials that directly compared the efficacy of two or more different drugs. The class~     III antiarrhythmic drug Ibutilde is approved for the acute termination of atrial~     fibrillation and atrial flutter of recent onset and has been shown to be superior to sotalol~     and equivalent to flecainide in this indication. Recently, the relatively atrial selective~     antiarrhythmic agent vernakalant has been approved by the European Commission for the rapid~     conversion of recent onset AF to sinus rhythm in adults. The investigators hypothesize that~     the period of time needed for cardioversion to sinus rhythm and the efficacy of~     cardioversion within 90 minutes is different between vernakalant and ibutilide in patients~     with recent-onset atrial fibrillation.~   "
123221|NCT01442818|"~     The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain~     relief and patient satisfaction when compared to scheduled intravenous analgesia following~     vaginal reconstructive surgery.~   "
122848|NCT01447849|"~     The investigators hypothesize that the symptoms of chronic constipation in some patients are~     developed due to diminished production and secretion of the alimentary tract mucus resulting~     in poor lubrication.~      Therefore, the investigators assume that administration of lubiprostone may restore this~     lubrication impairment by stimulation of mucus production and secretion within the~     gastrointestinal tract.~   "
122849|NCT01447836|"~     Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the~     outcome. As a measurement for liver function, Plasma clearance rate of indocyanine green~     (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses~     include: PDR-ICG is lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be~     lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG~     correlates with abdominal perfusion pressure; change of PDR-ICG in early phase correlates~     with change of transaminase or bilirubin in late phase of sepsis.~   "
122850|NCT01447823|"~     The aim of this study is to evaluate standard investigations performed in patients with~     bolus impaction in a prospective observational field study. In bolus impaction, ingested~     food boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused~     by reflux disease or motility disorders are possible causes of bolus impaction. How common~     these causes are has up to date never been investigated. The discovery of eosinophilic~     oesophagitis has broadened differential diagnosis of bolus impaction. Currently high~     resolution oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy~     in the assessment of bolus impaction at the University Hospital Zurich.~      The collection of these examination results is the aim of this prospective unrandomised~     observational field study to assess weather the currently applied procedures are valid to~     diagnose the cause of impaction to find optimal therapy for each patient.~   "
122851|NCT01447810|"~     Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological~     impairment which can occur in children as a result of a brain tumor or related treatment.~     This impairment can negatively impact the child's functional abilities and movement~     development, making it difficult for them to play, learn to feed, dress or bathe themselves,~     and to participate fully in home, daycare, or school environments. Poor movement skills may~     also impact overall quality of life. Constraint Induced Therapy is a rehabilitation~     technique which has been found to improve the child's abilities to move their arms following~     neurological injuries like stroke and traumatic brain injury in both adults and children.~      The aim of this study is to evaluate the feasibility of implementing a constraint induced~     movement therapy program in a small group of children with a brain tumor and hemiplegia.~     Children who participate in the program may experience improved ability to use their weak~     arm leading to increased participation in meaningful activity and improved quality of life.~   "
122852|NCT01447797|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of Irbesartan and Atorvastatin in combination as HCP0912~   "
122853|NCT01447784|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is~     associated with poorer lung function, greater medication requirements and more asthma~     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there~     is evidence that HDMA leads to the development of asthma, in addition to exacerbating~     pre-existing asthma in HDM-sensitised patients.~      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,~     currently being developed for the treatment of HDM allergy~      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune~     HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental~     Exposure Chamber (EEC)).~   "
122854|NCT01447771|"~     Breast cancer is a common malignancy among women in the United States. There are a variety~     of treatment decisions that need to be made. This study has been developed after a review of~     the literature demonstrated that women with breast cancer are making decisions regarding~     complex therapy issues in a way that is not congruent with their decision-making control~     preference.~      Some patients want to be empowered with information so that they can actively participate in~     the decision making about their care; others want to rely on the recommendations made by the~     oncologist. This is important because patients who were not satisfied with their adjuvant~     treatment decision noted a negative effect on quality of life and self image. These patients~     had more difficulties with treatment side effects; including aches, hot flashes, pain, and~     mood alteration. In additions the Institute of Medicine recommended that patient~     centeredness be a key aim of health care organizations and that all patients be given the~     opportunity to exercise the degree of control they choose over health care decisions that~     affect them.~      It is hypothesized that women making decisions regarding adjuvant therapy who are supported~     to make decisions based on their preferred level of control will have positive psychological~     outcomes.~   "
122855|NCT01447758|"~     The purpose of this Phase Ib study is to investigate the safety, tolerability and~     pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions~     from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I,~     II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be~     performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that~     increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation~     of the safety and tolerability data will assess whether a stepwise increase in the~     percentage of to be treated BSA is justified. Cohort IV will start dosing after~     finalisation of Cohort II and after submission of data from Cohort I and II to the national~     authority and IEC for review.~   "
122872|NCT01447537|"~     The investigators conducted a pilot study including 17 patients with liver cirrhosis showing~     that a moderate exercise programme during three months increased thigh~     circumference,exercise tolerance and quality of life without adverse effects. The present~     study aim to more accurately evaluate the effect of exercise on muscle mass, effort~     tolerance and inflammatory response in patients with cirrhosis. This study will include 30~     patients with compensated liver cirrhosis that will be randomized into two groups: exercise~     group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response~     and quality of life will be made at the beginning and at the end of the study.~   "
124349|NCT01428024|"~     The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip~     products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the~     injection technique.~   "
122856|NCT01447745|"~     Although it is frequently mentioned in the media that overweight and obesity have reached~     epidemic proportions worldwide and in this country, some Canadians are perplexed and~     sometimes confused about the role of obesity in diabetes and heart disease. In fact, the~     investigators even hear from time to time that there could be healthy obese individuals.~     In clinical practice, assessment of obesity as a risk factor for cardiovascular disease~     (CVD) remains a challenge as even some physicians are confused. However, studies conducted~     in our laboratory and by other research teams around the world over the last 20 years have~     clearly shown that body shape is more important than body size when evaluating the risk of~     overweight/obesity and that high accumulation of abdominal fat (excess belly fat) increases~     the risk of diabetes and cardiovascular disease (CVD).~      The investigators now need to better understand the link between excess belly fat and~     atherosclerosis (the thickening of artery walls by fatty deposits, also referred to as~     atherosclerotic plaque), leading to complications such as angina (chest pain) and myocardial~     infarction (heart attacks). Using non-invasive imaging techniques such as magnetic resonance~     imaging, the investigators therefore propose to examine the relationships between measures~     of fatness and of abdominal fat and the size of atherosclerotic plaque in large blood~     vessels of apparently healthy human subjects. This study is also a unique opportunity to~     look, for the first time, at the relationship between belly fat, blood sugar, several~     well-known risk factors for heart disease (cholesterol, blood pressure, cardiorespiratory~     fitness, etc.) and the size of atherosclerotic plaques. This research program should pave~     the way to the development of new improved preventive/therapeutic approaches focusing not on~     body weight but rather on abdominal fat and associated blood abnormalities which are~     predictive of the development of atherosclerotic plaques leading to the premature~     development of heart disease.~   "
122857|NCT01447732|"~     This is a two-part, Phase 1 open label, multi-center, dose escalation study of~     CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer~     respond to standard therapy or for whom no standard therapy is available.~   "
122858|NCT01447719|"~     This study is designed to test the relationship between measurements of brain amyloid using~     florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by~     histopathological assessment. The study will address the following specific aims:~        1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation~          analysis (measuring the correlation between the global visual rating of brain amyloid~          plaque density on an independent blinded read of the florbetapir F 18 PET scan and the~          cortical amyloid plaque density at autopsy as assessed by histopathology for subjects~          in the autopsy cohort).~        2. To determine the sensitivity and specificity of an independent blinded visual read~          assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded~          neuropathological assessment made at autopsy.~   "
122859|NCT01447706|"~     To determine whether the combination of MM-121 plus paclitaxel is more effective than~     paclitaxel alone~   "
122860|NCT01447693|"~     Background.~      Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is~     regarded as one of the most bothersome symptoms in patients on chronic dialysis.~      The pathogenesis of uremic itch remains unclear. Several theories have been proposed like~     dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.~      Many treatment modalities have been tried to reduce uremic pruritus, however , the majority~     of them produced only temporary improvement. Therefore , every new therapeutic option for~     uremic pruritus is desirable.~      This study will undertaken to evaluate the efficacy of a cream which included olive oil and~     omega-3 fatty acids.~      Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.~      The product is unique and based on patented technology developed by the Technion Research~     and Development Foundation in Haifa.~      Olive Omega-3 is an ointment composed of all natural ingredients. The main active~     ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin~     with fatty acids that are vital for its proper functioning and help in the skin recovery.~     Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing~     water retention in the upper layer of the skin.~      When applied on clean skin , the product is quickly absorbed , producing a sensation of~     relief within a short time period. Treatment can be repeated as often as required with no~     limitations and its use is not contraindicative of any other medical treatment.~      Patients and Methods.~      About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in~     the study.~      All patients will undergo dermatologic examination. All patients will be score by intensity~     of itching according to 3-point scale , as follows:~        1. - patches of fine , powdery scales~        2. - moderate scaling with beginning cracks~        3. - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for~          50% of body and Vaseline ointment for the second one. The treatment will repeated twice~          daily for two weeks.~      At the end of 2 weeks application global tolerance will evaluate using the following 3-point~     scale:~        1. very good~        2. good~        3. poor~      At the same time global agreement of the patients will evaluate according to the following~     scale :~        1. - very satisfactory~        2. - satisfactory 3- poorly satisfactory.~      Statistical analysis will be performed by use of Wilcoxon test .~   "
122861|NCT01447680|"~     The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus~     antibody testing when using routine plasma versus SMARTplasma from the same blood sample.~     SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™~     (SMARTstim™ in the USA).~   "
122862|NCT01447667|"~     The purpose of this study is to determine:~        -  The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA~          treatment~        -  The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the~          gold-standard histology score predicting hepatic fibrosis~   "
122863|NCT01447654|"~     Objective The objective of the study is to assess the structural and functional cardiac~     effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).~      Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up~     period is 12 months. 130 patients with HCM will be included in predefined subgroups.~     Genotype positive relatives with borderline hypertrophy (> 13 mm) will also be included.~     Data on individuals with borderline hypertrophy will be analysed separately from the rest of~     the cohort.~      Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall~     thickness.~   "
122864|NCT01447641|"~     The purpose of this study is to assess both the sleep and circadian (24-hourly biological~     rhythms) physiology of people with cluster headache. For sufferers with the episodic form of~     the disorder this will involve observation at two separate time points, once when~     experiencing attacks (in-bout) and once when attack free (out-of-bout).~      The study will include measurement of basic rest-activity patterns, sleep timing and timing~     of individual attacks, as well as a more detailed study recording sleep and circadian~     rhythms under clinical conditions over consecutive nights.~      Studying the differences in these processes in single individuals when they are both~     experiencing and free from attacks might provide insight into the brain mechanisms involved~     in triggering the bouts of attacks and individual attacks themselves. An improved~     understanding of this area may help design improved treatment options in future.~   "
122865|NCT01447628|"~     This study will establish whether intravenous iron replacement has clinical benefit in~     idiopathic pulmonary arterial hypertension.~      A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate~     whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary~     haemodynamics, exercise capacity and quality of life and is well-tolerated.~   "
122949|NCT01446536|"~     Hypothesis: Quality Improvement tools like Heart Failure Discharge Checklist which~     emphasizes on proper education to patients, ensure appropriate dose titration and~     counselling improve outcome in congestive heart failure (CHF).~   "
122866|NCT01447615|"~     Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda, represents~     the first study that measures medium-term efficacy and cost-effectiveness of a family~     economic empowerment intervention for AIDS-orphaned children. The usual care provided to~     AIDS orphans in sub-Saharan Africa consists mainly of informal counseling as well as limited~     material support (e.g., specifically school lunches, textbooks for the required subjects,~     and note-books). Given the challenges facing these children and their caregivers, further~     supports are needed in order to help them successfully make the transition from primary~     school to secondary school and into adolescence. In the context of resource-poor countries,~     interventions that improve families' economic capabilities are likely to be particularly~     consequential. Both theory and prior research indicate that economic instability (including~     poverty) constitutes one of the primary risk factors for AIDS-orphaned children's~     risk-taking behaviors (including sexual risk-taking), poor mental health functioning, and~     poor educational outcomes. Thus, the lack of economic security constitutes an important risk~     factor for AIDS-orphaned children. Yet, to-date, few interventions aimed at care and support~     of AIDS-orphaned children have incorporated components to address family-level~     poverty/economic instability of the children and their caregiving families. Within this~     context, there is a need for innovative interventions that promote sustainable (more than~     short-term) economic and behavior change among AIDS-orphaned children and create the~     supports necessary to sustain these changes.~   "
122867|NCT01447602|"~     The investigators are adapting Interpersonal Psychotherapy (IPT-A) for adolescents who are~     referred to emergency services either for a suicide attempt or for being evaluated as high~     risk for suicidal behavior. The investigators will recruit 15 adolescents ages 12-19 years~     who present with a diagnosis of major depression, dysthymic disorder, depression disorder~     not otherwise specified who have a history of a suicide attempt in the past 2 months or a~     non-medically lethal attempt that may require psychiatric hospitalization, suicide attempt~     that is or report current suicidal ideation with a plan/intent, and treat them in an open~     clinical trial. The treatment will be conducted twice weekly for the first 8 weeks of~     treatment and then weekly for the remaining 12 weeks of the study. Using feedback from~     clinicians and participants, the investigators will make further modifications to the manual~     in preparation for conducting a larger controlled clinical trial.~   "
122868|NCT01447589|"~     The aim of this clinical trial is to test whether the drug nelfinavir, which can increase~     the effectiveness of radiotherapy, can be given safely at the same time as a full dose of~     radiotherapy for lung cancer.~      It is thought that one way that nelfinavir works is through causing changes in the blood~     vessels within tumours. The status of tumour blood vessels and the blood flow through them~     will be investigated during the trial using special imaging techniques. The dose of~     radiation used in this trial is greater than that used in previous trials with nelfinavir in~     other disease settings and the response of normal lung to the combination of nelfinavir plus~     radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few~     patients that participate and will be gradually increased in subsequent groups of patients~     provided that no worrying side effects are identified. There is a single report of serious~     side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he~     was also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold~     higher than the highest dose level to be tested in this trial. An important goal of this~     trial is to select the optimum dose of nelfinavir to be used in combination with lung~     radiotherapy, that can then be tested more extensively in future trials.~      The radiotherapy treatment in this trial has been carefully designed to minimise the amount~     of healthy lung that receives radiation. Some specialised imaging techniques will be used~     during radiotherapy planning and delivery to help ensure that the lung cancer is targeted~     very precisely by radiation and that normal lung is avoided as much as possible.~      One effect of nelfinavir is to interfere with the function of a particular protein in cells~     (called AKT). The degree to which this happens can be measured in cells from blood or tissue~     samples. Therefore, another aim of the study is to investigate AKT and related proteins, to~     check whether nelfinavir is having the predicted effect.~   "
122869|NCT01447576|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major~     Depressive Disorder (MDD).~   "
122870|NCT01447563|"~     Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet~     activation, is widely used to prevent and reduce the risk of thrombotic events. Objective:~     the aim of the present study is to evaluate the bioequivalence of two oral formulations of~     75 mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period~     crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral~     dose of the test or reference drug will be followed by a 7 day washout period, after which~     subjects will receive the alternative formulation. Blood samples were collected up to 24 h~     after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel~     carboxylic acid metabolite was determined using high-performance liquid~     chromatography-tandem mass spectrometry area under the plasma concentration time curve from~     zero to the last quantifiable level (AUC0-t), area under the plasma concentration time curve~     extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma~     elimination half-life (Tmax) and plasma half-life (T1/2) were calculated for both~     formulations.~   "
122871|NCT01447550|"~     This study assessed the effectiveness and safety of bosentan when administered to~     thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was~     designed,included in which patients with ulcer and/or pain at rest were treated with~     bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter~     uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or~     minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic~     changes.~      12 patients were included were current smokers. With bosentan treatment, no new ischemic~     lesions were observed in all but one patient. Overall, clinical improvement was observed in~     12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after~     bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic~     resonance image an increase of distal flow was observed in 10 out of the 12 patients. All~     patients experienced a statistically significant improvement in their BAFMD values~     (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of~     the treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of~     clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves~     further investigation in the management TAO patients.~   "
122885|NCT01447368|"~     This is a pilot, prospective randomized controlled study with the primary objective to~     evaluate and compare medical treatment of SHPT, namely oral cinacalcet versus surgical~     treatment, that is, parathyroidectomy with forearm autografting, on the progression of~     coronary artery and valvular calcification in endstage renal disease patients over 12~     months. The change in arterial stiffening and bone mineral density as well as nutritional~     status will be evaluated as secondary objectives of this study.~   "
122873|NCT01447524|"~     Caloric restriction in obese diabetic patients quickly improves glucose control,~     independently from weight loss. However, the early effects of a very-low calorie diet (VLCD)~     on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes~     are still unclear.~      The objective of this study was to investigate the relative contributions of insulin~     sensitivity and/or secretion to the improvement in glucose metabolism, after one week of~     caloric restriction, in severely obese diabetic patients.~      For this purpose, hyperglycemic clamps were performed in 14 severely obese (BMI> 40 kg/m2)~     patients with type 2 diabetes in good glucose control (HbA1c <7.5%), before and after 7 days~     on VLCD 400 kcal/day.~   "
122874|NCT01447511|"~     This research study will help determine how a person's genetic makeup affects their response~     to drugs, the ability of the body to break down drugs, and their potential to experience an~     interaction between drugs. The investigators are investigating the drug interactions with~     the commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and~     prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart~     attacks, and strokes. The investigators chose warfarin for this study because it is a~     commonly used drug and must be monitored closely to avoid side effects. The investigators~     are interested in studying whether individuals with certain genetic profiles react~     differently to warfarin when it is combined with other drugs. This research is being done to~     see if certain genetic profiles require us to adjust warfarin doses differently than is~     needed for the general population. Genetic profiles of subjects are determined from their~     participation in the Pharmacogenetics Registry study (investigator Richard Brundage,~     University of Minnesota).~      The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the~     warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive~     interaction.~   "
122875|NCT01447498|"~     In a prospective randomised study design to investigate, if a systematic risk factor~     screening for bleeding ulcer in patients, who following percutaneous coronary intervention~     (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel,~     followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased~     risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that~     PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors,~     pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be~     done to ascertain whether PPI treatment increases the risk of coronary events. Further~     analyses will be made to see whether PPI prophylaxis in high risk patients can increase~     compliance with the antithrombotic treatment through a reduction of side effects, thereby~     reducing the risk of myocardial infarction in particular stent thrombosis. The study~     population will be analyzed further to identify the patients, who will benefit the most from~     PPI prophylaxis Hypothesis: screening heart patients for risk factors for bleeding ulcer and~     subsequently treating high risk patients with PPI can reduce the incidence of bleeding ulcer~     and increase compliance with the antithrombotic treatment; thereby possibly reducing the~     risk of coronary events and improving survival. Initial a description of the prevalence of~     risk factors will be done.~   "
122876|NCT01447485|"~     This study will assess the pharmacokinetics and safety following single dose of valsartan in~     Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic~     syndrome.~   "
122877|NCT01447472|"~     The purpose of this study are:~        1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and~          caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism~        2. to evaluate gender differences in the human pharmacology of MDMA~        3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the~          effects and pharmacokinetics of MDMA.~   "
122878|NCT01447459|"~     The investigators hypothesize that reinforced asthma education improves long-term outcomes~     in children with asthma.~      Specific Aims and Objectives:~        1. To determine the retention rate of parental knowledge about asthma;~        2. To evaluate the clinical status, quality of life and healthcare costs of children with~          asthma following an educational intervention.~   "
122879|NCT01447446|"~     This prospective, multicenter, observational cohort study will evaluate the efficacy and~     safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatment regimens containing~     direct-acting antivirals in patients with chronic hepatitis C who are treatment-naïve or~     treatment-experienced and HIV HCV co-infected. Data will be collected from patients~     receiving treatment according to current Summary of Product Characteristics and local~     labeling for the duration of their treatment and a 24-week follow-up.~   "
122880|NCT01447433|"~     The purpose of the study is to determine whether calcium plus vitamin D supplementation is~     conducive to weight and fat loss during energy restriction in very-low calcium consumers.~   "
122881|NCT01447420|"~     This multi-center, open-label study will evaluate the efficacy and safety of Pegasys~     (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in~     treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys~     (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated~     time of study treatment is 48 weeks, follow-up is 24 weeks.~   "
122882|NCT01447407|"~     This partially-blind, placebo controlled study is a Phase 1b study using an investigational~     vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will~     compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose~     level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID)~     compared to placebo delivered ID.~   "
122883|NCT01447394|"~     The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon~     Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC)~     compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.~   "
122884|NCT01447381|"~     While many patients with atopic dermatitis (eczema) can be managed with topical creams and~     treatments for itch, some children have such severe, long-standing disease that they need~     treatment with oral medications that decrease the ability of the immune system to react.~     However, there is not enough information on the proper use of these medications or how well~     they work compared with each other. The current study looks at the response of children~     treated with these medications to provide this information and improve their use.~   "
122888|NCT01447329|"~     The investigators propose to complete a randomized controlled trial to compare ear~     acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and~     left ear plus standard of care versus standard of care alone for symptomatic treatment of~     pain following ambulatory arthroscopic knee surgery. After the subject has been discharged,~     phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month.~     These contacts will be used to assess the subject's pain level, ambulation status, doses of~     analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be~     asked the PIQ-6 Pain Impact Questionnaire.~   "
122889|NCT01447316|"~     This is a short term study of the effects of bariatric surgery on body composition, gait~     parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly~     obese patients who are already scheduled for a bariatric surgical procedure.~   "
122890|NCT01447303|"~     This study will compare changes in outcomes following viscosupplementation for knee~     osteoarthritis.~   "
122891|NCT01447290|"~     This is a non-inferiority, prospective study of the relationship between the 24-hour urine~     protein collection and spot protein:creatinine ratio in the diagnosis of preeclampsia~     involving a sample of 18-45 year-old pregnant women attending the new Obstetrics~     orientation. The investigators will follow all participants who consent to be part of this~     study throughout their entire pregnancy. Those who get evaluated for preeclampsia will then~     have a P:C ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour~     urine collection (standard of care). Those participants who are not evaluated for~     preeclampsia during their pregnancy will be dropped from the study.~      Participants evaluated for preeclampsia during the prenatal period will be asked to provide~     a random spot clean-catch urine sample at intervals of approximately 0 and 24 hours~     following the initiation of the 24-hour urine collection. The patient's demographic and~     clinical data, as well as the spot protein:creatinine ratio and 24-hour urine protein will~     be collected and analyzed at the conclusion of the study period.~   "
122892|NCT01447277|"~     The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block~     only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a~     decrease in opiate consumption, pain scores, post operative nausea/vomiting, and~     post-anesthesia care unit (PACU) length of stay. The investigators are prospectively~     randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.~   "
122893|NCT01447264|"~     The interest in studying the impact of aquatic exercise on muscle strength of patients with~     rheumatoid arthritis came after publication of several studies that pointed to the potential~     benefit of exercise on the natural history of the disease, including reduction of pain,~     better immune response as well as aerobic fitness and functional capacity and increase~     muscle strength, endurance and quality of life.~      In general, the aquatic exercises are indicated for patients with chronic joint diseases,~     since the aquatic environment seems to be more secure for this population due to the~     reduction of joint loading, as well as gain range of motion.~      However, there are some difficulties to show the real and consistent beneficial effect of~     physical activity in these patients, such as the small number of randomized controlled~     clinical trials, short intervention period (4-8 weeks), lack of details of the exercise~     protocols used, methodological problems (heterogeneous measures to evaluate the outcome,~     change of medication). Moreover, no study evaluated the disease activity, according to the~     tool most used clinically worldwide, the DAS28.~      It is known that aquatic exercises without impact in healthy subjects are sufficient to gain~     muscle strength. Nonetheless, in people with joint limitation the benefits from these same~     exercises to gain muscle strength is not known.~      To date, no studies addressing the effect of aquatic exercise on muscle strength and disease~     activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a~     standardized protocol for prescribing of aquatic exercises. The choice of lower-limb~     strength was based on its relevance to the acceleration and deceleration during the march,~     as well as to perform activities of daily living, leisure and professional in these~     individuals.~      Thus, this study aims at:~        1. Exercises performed in the aquatic environment and without the concomitant use of~          overhead equipment are sufficient to promote gain muscle strength in the lower limb?~        2. What is the isolated effect of water resistance on muscle strength? Could it work as an~          impact that is used in exercises done on the land?~   "
122894|NCT01447251|"~     The investigators plan to recruit 140 patients (35 subjects in each group) over a period of~     18 months in a prospective study of matched/paired case-control subjects across the four~     groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the~     5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP)~     compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA~     requiring CPAP therapy without diabetes and are given the result of the diabetes risk score;~     2) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not~     given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without~     OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for~     OSA. The investigators will document that the patients are compliant with CPAP based on~     review of SD card data recorded by the CPAP machine. Each patient will have serum drawn for~     the biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose~     tolerance test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck~     and waist circumference, smoking history, blood pressure, and other standard vital signs~     will also be collected.~      There will be no follow-up of the study subjects in groups 3 and 4 and their participation~     in this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after~     enrollment to assess whether or not there is any change in CPAP compliance as measured by SD~     card.~   "
122895|NCT01447238|"~     The purpose of this study is to assess the yield of combination modalities in the diagnosis~     of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype~     needle based confocal laser-induced endomicroscopy miniprobe (nCLE).~   "
122896|NCT01447225|"~     To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer~     therapies~   "
122922|NCT01446887|"~     Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It~     remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A~     randomized double-blind study was conducted to determine whether prophylactic~     anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA~     were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation~     group. Patients were followed up 3 months later after surgery. DVT was tested by contrast~     venography. Investigator also used logistic regression analysis with variable selection for~     obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and~     clinical factors (mechanical compression, duration of surgery). THA with short duration of~     surgery did not require prophylactic anticoagulation.~   "
122950|NCT01446523|"~     The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic~     Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal~     hepatic encephalopathy.~   "
122897|NCT01447212|"~     The purpose of this study, SALOME, is to determine if 1) the closely supervised provision of~     injectable, hydromorphone (HDM; trade name Dilaudid™) is as effective as injectable~     diacetylmorphine (DAM; heroin) in the treatment of chronic, multi-morbid opioid-dependent~     individuals who have not benefited sufficiently from conventional treatments, and if a~     switch to the oral equivalent of hydromorphone and diacetylmorphine is as effective as the~     injection form. The availability of an effective, licensed opioid medication such as~     hydromorphone, for substitution treatment of chronic, multi-morbid treatment-refractory~     opioid-dependent individuals, would be of immense impact locally and internationally. It~     could help to establish alternative treatment options where for non-medical reasons Heroin~     Assisted Treatment would not be acceptable. Thus, one result could be the expansion of~     treatment options for the most difficult to treat heroin dependent persons. This would also~     be an important step for secondary prevention of HIV and Hepatitis C as well as a better~     integration of those patients in other medical treatments. Switching from intravenous to~     oral application would also reduce a lot of potential risk factors (like overdose, seizures,~     infections, etc) and side effects associated with the injection route. Additionally it could~     make these treatments more feasible in normal treatment settings, like existing methadone~     services.~   "
122898|NCT01447199|"~     The goal of this study is to understand factors which may influence risk for colorectal and~     other cancers in families. These factors include genetic variability, in combination with~     diet and lifestyle. In order to achieve these goals, we need to contact as many eligible~     participants as possible.~   "
122899|NCT01447186|"~     Objectives:~      The primary objective of this project is to develop and evaluate a Spanish-language slide~     set for administration in group settings, adapted from the content of the current guidelines~     and existing, self-administered ACS early detection decision aid.~      A guide for educators will accompany the slide set so that materials may be distributed on a~     broad scale at the completion of the project. It is expected that these products will be~     made available to community-based educators and screening programs to be used in support of~     an IDM process for early detection of prostate cancer with Spanish-speaking men.~      Specific Aims:~      To conduct an extensive review of the literature and other resources to identify themes~     related to early detection, concerns and beliefs about prostate cancer in Hispanic men.~     Findings will be used to adapt the slideset.~      To cognitive test the Spanish-language decision aid slide set with Hispanic men To conduct~     focus groups to evaluate the acceptability of the adapted slide set with Spanish-speaking~     Hispanic men who are candidates for prostate cancer screening. Participants will be tested~     for their knowledge of prostate cancer and acceptability of materials (e.g. length, clarity,~     amount and balance of information provided).~   "
122900|NCT01447173|"~     The study looks at how vitamin D supplement will improve the severity of asthma and lung~     function as well as biomarkers in asthmatic children.~   "
122901|NCT01447160|"~     The purpose of this study is to evaluate the effectiveness of facet joint infiltration with~     corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.~   "
122902|NCT01447147|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B~     in subjects with diabetic nephropathy.~   "
122903|NCT01447134|"~     1. Primary endpoint(s): To determine the relationship between the drug distribution and~          angiogenesis in head and neck cancer patients.~        2. Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate~          the parameters from the image study to clinical treatment response and prognosis.~   "
122904|NCT01447121|"~     This clinical trial is designed to assess an investigational blood glucose monitoring system~     with fingerstick blood in the hands of untrained intended users.~   "
122905|NCT01447108|"~     The Suicide Disease, Trigeminal Neuralgia (TN) is arguably caused by one of the most~     discrete and eloquently reversible central nervous system lesions known to the field of~     neurology.~      Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects~     with refractory TN showing a remarkable positive response rate to TN's treatment with Low~     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU).~      The primary objective of this study, therefore, is to determine whether this apparent~     efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could~     withstand the rigors of an n=1 crossover placebo control study.~      Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for~     at least six months will be screened for participation in the study based on rigorous~     inclusion and exclusion criteria. It is judged rather unlikely that such subjects will~     experience spontaneous regression of their disease in the course of this study.~      Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low~     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing~     with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU~     therapy for the next four weeks. Patients will be blinded to all treatments throughout the~     study. Patients will be instructed to use the device daily overnight, and remove it upon~     wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off,~     for a total of six- eight hours of intermittent treatment.~      At the end of the second month of the study, patients will be offered a choice as to whether~     they wished to continue with the current (active) device or go back to the 1st (sham)~     device.~      Patient's pain severity will be tracked every two weeks over the course of three months.~     Functional health and well being will be monitored at intake, post Placebo period, post~     Active period and at completion of the study.~   "
122906|NCT01447095|"~     The purpose of this study is to determine whether prostacyclin is effective in prevention of~     cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).~   "
122907|NCT01447082|"~     The main objective of this observational study is to characterize new users of quetiapine XR~     as well as new users of other study drugs (i.e. the comparison group) and to quantify the~     risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as~     well as in other study drugs.~   "
122908|NCT01447069|"~     The purpose of this study is to determine whether Salbutamol is effective in the treatment~     of severe heart failure due to ischemic and non- ischemic cardiomyopathy.~   "
122923|NCT01446874|"~     Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It~     leads to considerable morbidity and contributes to perioperative morbidity. There is~     evidence in literature that supports the use of strategies for improved oral hygiene and~     specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in~     mechanically ventilated patients. This study aims at utilizing a combination of these~     interventions in the perioperative period in patients undergoing planned thoracic surgical~     procedures.~   "
123018|NCT01445613|"~     The objective of the CANOPY trial is to assess the continued safety and effectiveness of the~     RX Acculink Carotid Stent System under commercial use in subjects at standard risk for~     adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of~     carotid stenting experience.~   "
122909|NCT01447056|"~     Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages~     called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called~     leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The~     disease has come back, may come back or has not gone away after treatment. This voluntary~     research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes,~     a new experimental therapy.~      Some patients with these diseases show evidence of infection with the virus that causes~     infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their~     diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas,~     and in some cases of NPC and LMS, suggesting that it may play a role in causing these~     diseases. Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV~     are able to hide from the body's immune system and escape destruction. We want to see if~     special white blood cells, called T cells, that have been trained to kill cells infected by~     EBV can survive in the blood and affect the tumor.~      This treatment with specially trained T cells has had activity against these viruses when~     the cells are made from patients with those diseases (or, after bone marrow transplant, from~     the patient's transplant donor). However, sometimes it is not possible to grow these cells;~     other times, it may take 2 to 3 months to make the cells, which may be too long when one has~     an active tumor. We are therefore asking if subjects would like to participate in this~     study, which tests if blood cells from a donor that is a partial match with the subject (or~     the transplant donor) that have been grown in the way described above can survive in the~     blood and affect the disease.~      These LMP-specific CTLs are an investigational product not approved by the Food and Drug~     Administration.~   "
122910|NCT01447043|"~     Retrospective, non-interventional, observational multi-center field study. Patients~     diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with~     ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and,~     if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch~     to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be~     documented and followed up. For each patient, demographics, medical history, administered~     treatments, results of ocular and visual assessments and other tests (where available) will~     be documented.~   "
122911|NCT01447030|"~     Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication~     with major implications for patient outcome. For most major BDIs, the recommended method of~     repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish~     hepatobiliary centres aiming to examine the perioperative and the long-term outcome after~     reconstructive HJ.~   "
122912|NCT01447017|"~     The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear~     drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The~     secondary objectives are to evaluate clinical cure and microbiological growth following~     treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.~   "
122913|NCT01447004|"~     Heavy metal has been reported that it can cause attention deficit and behavioral~     disturbance. The investigators hypothesis is that heavy metal is associated with children~     with attention deficit/hyperactivity disorder(ADHD).~   "
122914|NCT01446991|"~     This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing~     Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate~     brachytherapy. There are 2 eligible populations of men, all of whom will have selected~     brachytherapy as their treatment of choice for their prostate cancer. Either they have an~     enlarged prostate that requires size reduction to render brachytherapy technically feasible,~     or they require androgen ablation in conjunction with brachytherapy for optimal tumor~     control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in~     > 30% of men.~   "
122915|NCT01446978|"~     Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability~     to induce protective immunity in immunosuppressed travelers are scarce. The investigators~     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis~     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).~      In a previous study, 2 doses were not considered effective and there is therefore need for a~     study with an additional dose~   "
122916|NCT01446965|"~     This study explores the hypothesis that wearable defibrillators can impact mortality by~     reducing sudden death during the first three months after a heart attack in persons with~     high risk for life-threatening arrhythmias.~   "
122917|NCT01446952|"~     This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E~     δ-Tocotrienol in subjects with resectable pancreatic tumors.~   "
122918|NCT01446939|"~     Parkinson´s disease (PD) diagnosis is based upon clinical examination. Although imaging has~     helped doctors to identify many diseases, it still does not add too much information for the~     diagnosis of Parkinson´s disease. The investigators are going to perform a large sample~     study including PD patients, essential tremor and healthy volunteers in order to evaluate if~     MRI can help in the diagnosis. Our hypothesis is that fractional anisotropy (FA) in the~     caudal portion of substantia nigra is decreased in PD patients.~   "
122919|NCT01446926|"~     This study is designed to explore the safety and tolerability of an investigational~     pneumococcal vaccine through a step-down enrollment.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.~      Secondary Objective:~        -  To evaluate the immunogenicity of an investigational pneumococcal vaccine.~   "
122920|NCT01446913|"~     The goal of this study is to develop a novel study design to safely and ethically conduct a~     long-term randomized controlled trial among patients at high risk for both sleep apnea and~     cardiovascular events that will examine whether effective positive airway pressure(PAP)~     therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke~     have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular~     events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular~     death)in the first year post event, despite current prevent strategies. Therefore, the~     treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular~     outcomes in this high risk population.~   "
122921|NCT01446900|"~     The objective of this study is to confirm the efficacy of the association of R-2cda in~     patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of~     evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab~     alone in increasing and prolonging the duration of the response.~   "
122935|NCT01446718|"~     The purpose of this study is to determine sustained immunogenicity of the quadrivalent~     vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls~     age 9-14 years. This age range is within the World Health Organization (WHO) stipulated~     guidelines for national programs for the vaccine.~   "
123019|NCT01445600|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance.~   "
122924|NCT01446861|"~     Purpose The purpose of this study is to develop and validate multimodal testing of exocrine~     pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in~     patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be~     correlated to age group, genotype, nutritional status and quality of life. Earlier detection~     of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of~     therapeutically benefit.~      Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine~     pancreatic function in patients with cystic fibrosis.~      New functional testing of exocrine pancreatic function is superior to traditional testing~     with fecal elastase.~      MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.~      Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and~     parenchymal changes in cystic fibrosis patients.~      Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and~     development of hepatocellular carcinoma in the liver of cystic fibrosis patients.~      Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in~     duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with~     exocrine pancreatic function.~   "
122925|NCT01446848|"~     The purpose of this study is to investigate the effects of iron supplementation in patients~     with pulmonary arterial hypertension and iron deficiency.~   "
122926|NCT01446835|"~     The purpose of this study is to compare the cosmetic appearance of two different contact~     lenses on Asian eyes.~   "
122927|NCT01446822|"~     This is a single-center, prospective, randomized, controlled trial comparing two established~     transurethral electrical resection methods of urinary bladder tumors regarding their risk of~     stimulating the obturator nerve.~      One of the major safety issues with transurethral resection is bladder perforation as a~     consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly~     a risk of resection of lateral bladder wall tumors near the course of the obturator nerve.~     It has been advocated that bipolar may be superior to monopolar resection, based on its~     different electrical properties. This is an important safety aspect for the patient.~      Main study question: In patients with lateral wall urinary bladder tumors, is bipolar~     superior to monopolar transurethral electroresection regarding risk of stimulation of the~     obturator nerve without preoperative nerve block?~   "
122928|NCT01446809|"~     This randomized pilot clinical trial studies pazopanib hydrochloride followed by~     chemotherapy and surgery in treating patients with soft tissue sarcoma. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes that are~     needed for cell growth and may also stop the growth of soft tissue sarcoma by blocking blood~     flow to the tumor. Giving pazopanib hydrochloride and chemotherapy before surgery may make~     the tumor smaller and reduce the amount of tissue that needs to be removed.~   "
122929|NCT01446796|"~     Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left~     ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart~     failure. However, little is known about RV pacing in patients with advanced heart failure~     treated with an implantable left ventricular assist device (LVAD). The univentricular~     support provided by contemporary continuous flow LVAD's has improved outcomes for many~     advanced heart failure patients, yet the incidence of RV failure in the early post-operative~     period following implantation is associated with significantly reduced survival and~     increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on~     RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony,~     RV overdrive pacing may counteract these adverse mechanical alterations, improving RV~     systolic function and ultimately LVAD function.~      The investigators will recruit all patients referred for an implantable, continuous flow~     LVAD at Duke University Medical Center who have an existing implantable dual-chamber~     cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to~     compare continuous right ventricular pacing vs. native ventricular conduction at equivalent~     heart rates. Multiple clinical outcomes will be examined over a two week period~     post-operatively including invasive hemodynamics, vasoactive medication use, end-organ~     function, RV function by Echocardiography as well as patient symptoms and functional status.~   "
122930|NCT01446783|"~     The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella~     tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen~     synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in~     skin.~      The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and~     poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by~     IGF-I.~   "
122931|NCT01446770|"~     The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a~     hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated~     with keloid scarring in subjects undergoing surgical revision of keloid scars.~   "
122932|NCT01446757|"~     The main purpose of this randomised controlled trial is to study if a Comprehensive~     Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve~     outcomes such as health and health-related quality of life among both patients and~     relatives, feeling of safety among both patients and relatives and reduce costs, compared~     with usual care.~   "
122933|NCT01446744|"~     Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers~     high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique~     can potentially allow radiation treatments to be focused more precisely, and delivered more~     accurately than with older treatments. This improvement could help by reducing side effects~     and by improving the chance of controlling the cancer by more precisely treating the cancer.~     The purpose of this study is to compare SABR with current approaches of chemotherapy and~     conventional radiotherapy to assess the impact on overall survival and quality of life.~   "
122934|NCT01446731|"~     This is a randomized phase II trial including 40 patients with castration resistant~     metastatic cancer prostate (CRMPC).~      Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel~     and docetaxel alone.~      The primary objective is to evaluate the vaccine specific immune response and patients will~     be evlauated with blood tests and DTH reactions during the treatment course.~      Secondary objectives are to evaluate clinical response by objective response~     (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine~     time to progression and overall survival.~   "
122936|NCT01446705|"~     Three out of four Veterans receive a portion of their care from non-VA providers. On April~     9, 2009, President Barack Obama directed the Department of Veterans Affairs and the~     Department of Defense to create the Virtual Lifetime Electronic Record (VLER). On August~     2010, Secretary of Veterans Affairs Eric K. Shinseki visited Indianapolis, and after~     visiting with leaders from the VA Health Services Research & Development (HSR&D) Center of~     Excellence and the Regenstrief Institute, he made the following public comments regarding~     the latest partnership between the two institutions: This new technology allows safer, more~     secure, and private access to electronic health information which, in turn, enhances our~     ability to continue providing Veterans with the quality care that they have earned.~      This new technology refers to the VLER HEALTH program that the Indianapolis VA is now~     implementing in partnership with the Regenstrief Institute and Indiana Health Information~     Exchange (IHIE). This VA-IHIE demonstration project is intended to create the capacity for~     VA institutions to exchange health information with community partners.~      Investigators from the VA HSR&D Center on Implementing Evidence-Based Practice are active~     collaborators in building and implementing this program. The VA-IHIE program provides the~     bi-directional exchange of health information between VA and non-VA providers. Based on our~     pilot study of linked VA-IHIE data, investigators are conducting an evaluation of the impact~     of the VA-IHIE demonstration project upon health care quality and cost of Veterans by taking~     advantage of the initiation of the implementation as a natural experiment.~   "
122937|NCT01446692|"~     A retrospective study using a data base of anonymized medical records. The purpose of the~     study is to examine the different therapeutic strategies for the management of patients with~     major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary~     care~   "
122938|NCT01446679|"~     This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve~     the category-specific targeted lipid levels.~   "
122939|NCT01446666|"~     Current practice guidelines recommend surveillance for hepatocellular carcinoma (HCC) in~     liver cirrhosis patients with ultrasonography (USG) every 6 months. However, with the~     advancement of cirrhosis, the sensitivity of USG decreases, while the risk for HCC~     increases. Gadoxetic acid (Primovist®)-enhanced magnetic resonance imaging (MRI) has been~     demonstrated to be of clinical value for diagnosis of HCC with the detection sensitivity of~     90-95%, which is significantly higher than USG. The hypothesis to be proved by this study is~     as follows; Primovist-MRI should show significantly higher sensitivity compared to USG for~     the detection of early stage HCC when both of these imaging modalities are used with the~     interval of 6 months in patients with cirrhosis at high risk of developing HCC.~   "
122940|NCT01446653|"~     The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive~     intervention against one comparison and one control condition. Because prevention of~     Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR~     contraception, the primary endpoints will be rates of risky drinking and ineffective~     contraception at six-month follow-up, in addition to dichotomously defined successful~     outcome that will be observed whenever a woman has sufficiently altered one or both of the~     behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to~     identify a transferable intervention that effectively reduces behaviors that put women at~     risk for AEP and alcohol-related birth defects including FASD.~   "
122941|NCT01446640|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     combined with intrathecal administration of autologous bone marrow derived mesenchymal stem~     cells to patients with spinal cord injury.~   "
122942|NCT01446627|"~     The purpose of this study is to evaluate the incidence of wound breakdown or wound infection~     following skin closure with Insorb subcuticular absorbable staples versus metal staples~     after cesarean section through a retrospective chart analysis.~   "
122943|NCT01446614|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     administration of autologous bone marrow derived mesenchymal stem cells to patients with~     Parkinson's disease.~   "
122944|NCT01446601|"~     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve~     stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a~     potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea~     (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.~   "
122945|NCT01446588|"~     The investigators aim to pilot test the efficacy of a yoga intervention designed~     specifically for individuals with ocular hypertension. The investigators would like to find~     out if a combination of breathing, postures and meditation may help to reduce intraocular~     pressure in the short term after each yoga session, and also long-term across an 8-week~     program. Subjects will participate in the yoga intervention sessions led by Dr. Pamela Jeter~     once a week at the investigators center, and will be asked to practice at home at least~     twice a week using a audio CD.~   "
122946|NCT01446575|"~     Transverse myelitis is an inflammatory disorder of the spinal cord that leads to~     disabilities of gait. Dalfampridine, a sustained-release potassium channel blocker that has~     been shown to be effective in improving gait and other neurologic functions in multiple~     sclerosis. Dalfampridine has the potential to improve gait and neurologic function in~     patients with transverse myelitis as this rare disorder shares a similar pathogenic process~     with multiple sclerosis. The investigators propose a clinical trial to test the efficacy of~     dalfampridine in this particular cohort of patients.~      The clinical trial that the investigators propose to conduct will focus on monophasic~     idiopathic Transverse Myelitis (TM) and will evaluate the efficacy of dalfampridine in~     primary neurologic outcome, 25-foot timed walk, and several secondary outcomes including~     valid behavioral and neurophysiological measures. To better understand the mechanisms~     underlying the proposed behavioral gains, the investigators will use Transcranial Magnetic~     Stimulation as the neurophysiologic measure to identify changes in corticomotor excitability~     in the spinal cord.~   "
122947|NCT01446562|"~     The primary objective of this study is to establish in a prospective phase II study the~     efficacy of 90Yttrium ibritumomab tiuxetan (90Y-RIT) after first line induction~     immuno-chemotherapy with R-CHOP in patients with high-risk advanced stage follicular~     non-Hodgkin's lymphoma, as assessed by the complete response rate.~   "
123046|NCT01445171|"~     The purpose of this clinical investigation is to confirm that the safety and performance of~     the EDWARDS INTUITY Valve System.~   "
122951|NCT01446510|"~     A systematic review and meta analysis will be performed of risk assessment models for Venous~     thromboembolism (VTE including pulmonary embolism PE and deep venous thrombosis DVT)in~     hospitalized medical patients. The goal of this study is to evaluate whether the incidence~     of VTE is lower in patients that are evaluated with a risk assessment model and treated with~     thromboprophylaxis for their assigned level of risk.~   "
122952|NCT01446497|"~     Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic~     (Timolol) ophthalmic solutions in normal tension glaucoma patients.~   "
122953|NCT01446484|"~     T regulatory cells (T regs) are responsible for immune tolerance in solid organ transplant~     patients. This study will evaluate the treatment of children with kidney transplants either~     with Campath and other immune system suppressing medications alone or in combination with~     injection of autologous CD4+CD25+CD127lowFoxP3+ T regulatory cells expanded ex vivo. The aim~     of this study is to develop a new strategy that will be more effective in preventing organ~     rejection and maintaining patient health.~   "
122954|NCT01446471|"~     The aim of this study is to investigate the predictive value of the presence or absence of~     cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate~     based on previous research that patients who suffer a cardiac arrest and have cardiac~     activity on bedside ultrasound will have a greater chance of surviving to hospital~     admission. The investigators hypothesis is that the mortality rate in patients in cardiac~     arrest with no cardiac activity by ultrasound will have a mortality rate of 100%.~   "
122955|NCT01446458|"~     The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and~     Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic~     cancer is safe and well tolerated. This study will obtain preliminary data on the response~     of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer~     after it is resected surgically.~      In addition, the investigators will perform biochemical studies on the tumor tissue obtained~     from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure~     the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important~     in the behavior of pancreatic cancer cells.~      The data obtained from this trial will be extremely valuable to help improve the approach to~     treating pancreatic cancer in the future. If you do not undergo surgery after completion of~     FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under~     computer tomography (CT) -guidance in order to measure the effect of treatment on your~     tumor.~   "
122956|NCT01446445|"~     The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral~     valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the~     concentration time curve (AUC), in renal transplant patients receiving oral VGCV or~     intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated~     according to population pharmacokinetic model. Subsequent doses will be adjusted according~     to plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments~     could lead to increase the percentage of patients achieving a therapeutic exposure.~   "
122957|NCT01446432|"~     A study to validate two newly developed questionnaires for Dupuytren's Disease. The~     objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While~     there are standard and validated questionnaire instruments used to measure health related~     quality of life and function, they do not address patient specific issues. The investigators~     will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for~     Dupuytren's Disease.~   "
122958|NCT01446419|"~     To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve~     Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain.~     This is a prospective, double-blind, randomized, sham-controlled clinical trial with an~     optional crossover component.~   "
122959|NCT01446406|"~     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many~     patients do not recover to previous psychosocial function. Major reasons for poor outcome~     are delayed intervention for prodromal depressive and manic episodes as well as decreased~     adherence with treatment. Recently, electronic self monitoring of affective symptoms using~     cell phones to prompt patients to respond to weekly text messages has been suggested as an~     easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the~     electronic devises has been rather simple not including a bi-directional feed back loop~     between patients and providers and without electronic data on objective measures of the~     affective psychopathology. As part of an ongoing EU research program a software program for~     online electronic self-monitoring using a cell phone is being developed including an~     interactive feed back loop between patients, relatives and clinicians. Electronic~     self-monitoring includes subjective items such as mood, irritability, sleep duration,~     activity, alcohol consumption, medication intake and objective items of speech duration (on~     the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and~     physical activity (acceleration of the cell phone). The present PhD. study will in a~     randomized controlled single blind trial including 60 patients with bipolar disorder~     allocated to using the active cell phone program (intervention group) or to using a cell~     phone to usual communication (control group) during a 6 months study period.~      If the cell phone self-monitoring system is proved effective in preventing mood symptoms and~     improving psychosocial functioning,quality of life etc. in the present study there might be~     basis for extending the use of the system to treatment of patients with bipolar disorder in~     clinical practice in general.~   "
122960|NCT01446393|"~     To determine the specific structural and functional features of the peripheral arteriopathy~     in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.~   "
122961|NCT01446380|"~     The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum~     (PXE) disease in various tissues (eye, skin, arteries, etc).~   "
122962|NCT01446367|"~     The purpose of this study is to evaluate the corneal changes after performing 20 gauge~     vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal~     detachment.~   "
122963|NCT01446354|"~     Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative~     transfusion of allogeneic blood products which is associated with increased morbidity and~     mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of~     a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first~     line hemostatic agent on the perioperative use of allogeneic blood products.~   "
122984|NCT01446081|"~     Reduced quality of life, fatigue, and loss of physical function are common in patients~     getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot~     study showing that exercise during active chemotherapy for AML is feasible, safe, and may~     improve symptoms and physical function. The investigators now propose to compare our~     hospital-based supervised exercise program to usual care to see if exercise can improve~     symptoms, physical function, and improve treatment tolerability.~   "
122964|NCT01446341|"~     Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency~     department visits and are the most common musculoskeletal injury in the physically active~     population. Although the current accepted treatment of ankle sprains is to encourage early~     mobilization with functional rehabilitation, there is little high-quality evidence directing~     this clinical practice.~      This pilot study is to:~        -  provide quantitative data for estimation of mean outcome scores and standard deviations~          to allow subsequent sample size calculations~        -  evaluate the feasibility of the proposed study design~        -  assess patient enrollment issues specific to randomization into an active~          rehabilitation program compared to below knee immobilization.~   "
122965|NCT01446328|"~     In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and~     olanzapine will be compared head-to-head in patients with schizophrenia and related~     psychoses and followed for 12 months. The study is independent of the pharmaceutical~     industry, and in accordance with a pragmatic design a clinically relevant sample will be~     included with as few exclusion criteria as possible. The patients will be assessed~     repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as~     laboratory parameters. The study hypothesis is that clinically meaningful differences among~     the drugs will be disclosed in a pragmatic design.~   "
122966|NCT01446315|"~     Asthma is a common problem among US adults and children. Unfortunately many people with~     asthma continue to suffer from asthma symptoms that could be control with better asthma care~     and more attention to details such as triggers, and adherence. To date the only tools~     available and recommended by groups such as the national asthma guideline group consider~     only asthma burden and do not include information on the most common factors that adversely~     affect asthma control. This study provides one half of the enrolled primary care offices~     with the Asthma APGAR which is a system of patient completed questions and a care flow~     sheet. The other half of the enrolled practices will continue to provide usual care~     without the support of the Asthma APGAR system. The research questions is whether or not~     asthma control and asthma related quality of life will be improved in people with asthma who~     are cared for in the intervention practices that use the Asthma APGAR system.~   "
122967|NCT01446302|"~     The objective of this study is to characterize the hormonal and inflammatory responses to~     hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in~     the post-dialytic phase.~   "
122968|NCT01446289|"~     The study investigated the immune response induced by the Group B streptococcus vaccine in~     healthy pregnant women. In addition, the study investigated the amount of vaccine induced~     antibodies which were transferred to the newborn.~   "
122969|NCT01446276|"~     The purpose of this study is to investigate potential metabolic effects of resveratrol in~     obese healthy men with non-alcoholic fatty liver disease.~      The investigators hypothesize that resveratrol will:~        -  decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion~        -  decrease liver fat content~        -  increase insulin sensitivity~      The investigators will look at changes in:~        -  lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)~        -  liver fat content (MR liver spectroscopy)~        -  insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)~        -  body composition (DXA and MRI)~        -  lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose~          tissue)~   "
122970|NCT01446263|"~     Increased use of radial access for cardiac catheterization is being advocated because~     studies have showed lower arterial access related complication rates and higher patient~     satisfaction as compared to femoral access. However, little is known on patients with prior~     coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial~     proposed to test the hypothesis that bypass graft angiography and intervention via radial~     access provides lower vascular complication rates, similar contrast and equipment~     utilization and higher patient satisfaction when compared with transfemoral approach.~   "
122971|NCT01446250|"~     This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC),~     each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African~     American participants who have never received treatment for their chronic hepatitis C (HCV)~     genotype 1 infection.~   "
122972|NCT01446237|"~     This study is being conducted to obtain safety, efficacy, and satisfaction data on the~     combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent~     Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate~     or severe acne will be asked to apply the commercially available, over-the-counter products~     Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam~     Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment~     will be included.~   "
122973|NCT01446224|"~     This observational study is conducted as part of a systematic pharmacovigilance activity, to~     provide a population-based context for Pazopanib use outside of the clinical trial setting.~     The aims of the study are to examine the incidence of cardiovascular ischemia (including~     myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular~     accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients~     treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN),~     Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].~      Two databases will be utilized for this study: a large healthcare claims database in the~     U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large,~     geographically varied, non-trial populations in which to examine the incidence of the stated~     cardiovascular ischemic events and Torsades des Pointes.~   "
122974|NCT01446211|"~     The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared~     to conventional treatment in patients with a relapse of Wegener Granulomatosis with or~     without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety~     and quality of life of gusperimus treatment compared to standard treatment in patients with~     relapse of Wegener Granulomatosis receiving glucocorticoids.~   "
122975|NCT01446198|"~     The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is~     comparable to performance on the TIGRIS System.~   "
122985|NCT01446068|"~     The purpose of this study is to quantify the systemic inflammatory and metabolic response of~     lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.~   "
122976|NCT01446185|"~     Primary objective:~      Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment~     recommendation made (administration of chemotherapy or not, in addition to hormonotherapy)~     in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population.~      The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment~     intensity defined as a change in treatment recommendation from chemotherapy plus hormonal~     therapy to hormonal therapy alone or an increase in treatment intensity defined as a~     movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.~      Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast~     cancers. These are usually good prognosis tumors. However, on the basis of classical~     clinical and pathological prognostic parameters and markers, the international consensus~     guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases.~     Considering the natural disease history, such as documented by the EBCTCG meta-analysis,~     more than 50% of these patients are overtreated, which leads to unnecessary side effects and~     costs to the health system and to the society.~      Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N-~     patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best~     adapted to daily clinical practice as it does not necessitate any specific surgical~     procedure or tissue freezing.~      The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on~     three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The~     test has been commercially available in the USA since 2004, and is being used for more than~     50% of the HR+ N- patients in this country.~      While Oncotype DX has been validated in the USA, it needs to be independently evaluated in~     France, in the context of the local treatment guidelines and habits, to provide data that~     are meaningful to the French health system and to the French medical community.~   "
122977|NCT01446172|"~     While cognitive therapy and exposure therapy are both proven to be effective for panic~     disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould~     et al., 1995) the scientific knowledge about long-term course of these disorders is still~     scanty. Although several long-term outcome studies have been conducted, the quality of these~     studies has been questioned.~      The aim is to conduct a follow-up study of patients with either panic disorder with history~     of agoraphobia or agoraphobia without history of panic disorder. the patients were treated~     in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be~     included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined~     cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 -~     1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4~     (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy.~      In the follow-up study the participants will be requested to complete the same self report~     measures as they completed at intake, discharge and at previous follow-up times. the~     participants will also be interviewed using the SCID-I and II as they were at the previous~     assessments.~      The present sample is relatively unique in having received pure psychosocial experimental~     treatments. The very long term efficacy of cognitive therapy relative to behavioural~     treatmetns for agoraphobia can be evaluated, and the potential moderating effects of~     personality disorders can be assessed.~   "
122978|NCT01446159|"~     Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573~     in combination with an AI in adult subjects with HR+, HER2-negative MBC.~   "
122979|NCT01446146|"~     The purpose of this program is to compare two different methods of matching a Veteran to a~     PTSD treatment.~   "
122980|NCT01446133|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     rituximab can help to control CLL. The safety of this drug combination will also be studied.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells~     to die.~   "
122981|NCT01446120|"~     This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved~     Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick~     (buccal) , Releasing the insulin to the circulation, while the film is dissolved..~      Primary endpoint:~        1. The Cmax (Maximum Concentration of insulin in mg).~        2. Tmax (the time to Cmax in minutes)~        3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.~      Secondary endpoints:~        1. The glucose and C-peptide levels during six hours of the trial. (mg)~        2. The safety of the treatment in a descriptive manner by recording all adverse events in~          the study population.~      Methods~      Seven healthy volunteers will be randomly assigned to one of the following groups:~      A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.~      The study is designed a crossover, in which each group is treated 3-7 days of washout.~      The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject~     will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion~     and exclusion criteria).~      An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels,~     ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.~      Blood Insulin and glucose levels will be evaluated at baseline, and after the following time~     points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be~     evaluated at baseline and after the following time points: 60,120,240, 360 minutes.~   "
122982|NCT01446107|"~     Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most~     of the lesions are in the fissures of the first permanent molars. This study aims to~     investigate the effectiveness of three methods in preventing fissure caries in permanent~     teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver~     diamine fluoride solution. The cost-effectiveness of these methods will also be compared.~     About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the~     children will be conducted in school using portable dental lights and instruments to~     identify teeth that need caries prevention. The children will be randomly allocated to one~     of the three test or the control groups. Treatments will be provided in the study primary~     schools according to standard clinical protocols. Follow-up examinations will be carried out~     every six months for 30 months to assess whether the preventive methods are successful, i.e.~     no dental caries develops in the treated teeth. The findings of this study will be of great~     value to dentists and public health authorities in deciding on the most appropriate dental~     caries prevention programme for school children in China and other developing countries.~   "
122983|NCT01446094|"~     This study is designed to evaluate the feasibility and diagnostic performance of a novel~     rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.~   "
123017|NCT01445626|"~     This study will use retrospective data to evaluate the efficacy, safety, and re-injection~     interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).~   "
122986|NCT01446055|"~     Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb~     ischemia has been proved safe and effective. However, processing bone marrow by Ficoll~     density gradient centrifugation is not only time consuming but also expensive. Manually~     processing of bone marrow also results in large variation in therapeutic cell quantity and~     quality which directly leads deviation of safety and efficacy of the cell therapy. This~     study is aiming to compare an automated bone marrow processing system with a conventional~     manual method in term of safety and efficacy.~   "
122987|NCT01446042|"~     The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile~     of testosterone) and safety of TBS-1 in the treatment of hypogonadal men~   "
122988|NCT01446029|"~     The purpose of this study is to determine if the adoption of a chronic care model in~     conjunction with tele monitoring and case management can reduce the risk of death,~     hospitalization, emergency room visits, or admission to a skilled nursing facility in~     patients with chronic kidney disease compared to usual care.~   "
122989|NCT01446016|"~     The major purpose of this research study is to better understand how therapy works on~     different patients. This study is being offered to patients with a diagnosis of advanced or~     metastatic breast cancer who have failed anthracycline based therapy.~      The investigators want to see the response of breast cancer cell when treated with~     Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that~     is given through your vein. The chemotherapy used in this study is either Taxane~     (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).~   "
122990|NCT01446003|"~     This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic~     blood pressure in participants with mild to moderate hypertension.~   "
122991|NCT01445990|"~     Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments~     diagnosis in free tissue transfers is realized.~      These measures are done after surgical reconstructions with free tissue flap, simultaneously~     with clinical examination. These biological data aren't available to make clinical diagnosis~     of complication; only clinical examination is allowed in this way.~      A posteriori, clinical and biological parameters will be compared in order to determine if~     capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps~     monitoring.~   "
122992|NCT01445977|"~     This study is designed to collect data about the SoundBite™ Hearing System to answer~     specific questions. The hearing system has been cleared for commercial distribution by the~     Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what~     features and settings of this device provide the best hearing ability for people diagnosed~     with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).~   "
122993|NCT01445964|"~     An open-label, single-dose, three-treatment, three-period study to investigate the effect of~     SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration~     in healthy male Korean.~   "
122994|NCT01445951|"~     Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety~     of TI Inhalation Power in combination with a basal insulin versus insulin aspart in~     combination with a basal insulin~   "
122995|NCT01445938|"~     Primary Objective:~      To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite~     reduction ratio at 72 hours in pediatric patients with uncomplicated malaria~      Secondary Objectives:~        -  To assess the evolution of clinical signs and symptoms (including the need for a rescue~          therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with~          reference to Artemisinin-Based Combination Therapy (ACTs)~        -  To assess the pharmacokinetics profile of SAR97276A in pediatric patients with~          uncomplicated malaria~        -  To assess the safety profile of SAR97276A in pediatric patients with uncomplicated~          malaria~        -  To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A~   "
122996|NCT01445925|"~     The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by~     radiofrequency ablation would improve single procedure success rates for Radio Frequency~     Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term~     peri-procedural anti-arrhythmic drug therapy alone.~   "
122997|NCT01445899|"~     This is a two-part study. The first part (Stratum I) is an open-label, dose escalation,~     safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will~     be given to all patients who participate. Stratum I will determine the maximum tolerated~     dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively~     randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and~     safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in~     patients with DME.~   "
122998|NCT01445886|"~     The purpose of this study is to compare the efficacy and safety of indigo naturalis oil~     extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo~     naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an~     effective alternative for those who do not respond well to traditional therapy.~   "
122999|NCT01445873|"~     The objectives of this study are to develop research methods and corresponding materials for~     a study of the effectiveness of sitaxentan sodium (Thelin) in real-world settings; to~     pilot test these methods at three study centers in Europe; and to refine and finalize~     research methods and corresponding materials for possible use in a follow-on, full-scale~     examination of the effectiveness of sitaxentan sodium (Thelin) in real-world settings.~   "
123000|NCT01445860|"~     The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on~     the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.~   "
123001|NCT01445847|"~     In the literature, we found no randomized clinical trials addressing the using of IV~     lidocaine as prophylaxis for postoperative laryngospasm among adults.~      The aim of this study was to assess the effects of IV lidocaine on the incidence of~     postoperative laryngospasm of adults patients.~   "
123002|NCT01445834|"~     In this retrospective study the outcome of pelvic floor muscle training in 150 women will be~     tested regarding patients reported satisfaction and achievement of the incontinence~     improvement.~      Comparison of two age groups, controlled for BMI, parity and previous incontinence~     operations.~   "
123074|NCT01444755|"~     The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen~     in patient with resectable locally advanced gastric cancer in comparison with surgery alone.~   "
123003|NCT01445821|"~     ASSIST I was the first randomized trial in patients with scleroderma to not just slow~     disease progression but rather actually reverse it. It is the first treatment to have ever~     demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung~     capacity (TLC), high-resolution computed tomography (HRCT), and QOL. We now, therefore,~     purpose to compare the ASSIST I conditioning regimen of cyclophosphamide and rATG to a less~     intense regimen of rATG/cyclophosphamide/Fludarabine. In the new regimen the~     cyclophosphamide dose is decreased to 120mg/kg (60mg/kg/day x 2) compared to 200mg/kg~     (50mg/kg/day) in the standard regimen. The lower dose of cyclophosphamide will be less~     cardiotoxic. This study will determine if the less cardiotoxic regimen will be safer than~     the standard regimen and as effective as the standard regimen.~   "
123004|NCT01445808|"~     The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and~     Training Program (PMT) for the improvement of physical fitness in patients with stable~     coronary heart disease as compared to advice in exercise training or treatment as usual.~   "
123005|NCT01445795|"~     This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of~     INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a~     study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV),~     Treatment-naïve subjects.~   "
123006|NCT01445782|"~     This study will investigate the safety and tolerability of AZD2115 following administration~     of multiple ascending doses.~   "
123007|NCT01445769|"~     The purpose of this study was to evaluate the effect of an alternative dosing strategy of~     ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia~     vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in~     order to minimize the development of anemia and thrombocytopenia.~   "
123008|NCT01445756|"~     Intrauterine contraception is a very effective, long term, reversible form of birth control,~     and is increasingly used in young, nulliparous patients. However, there is potential for~     pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a~     previous history of vaginal delivery. The potential pain associated with insertion is often~     a significant barrier for patients when choosing and IUD for contraception. Several methods~     of pain control have been studied, but none have been shown to reduce pain at time of~     insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into~     the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena~     Intrauterine System) in young, nulliparous patients. This will be studied in a randomized,~     double-blind placebo-controlled trial.~   "
123009|NCT01445743|"~     That is a double-blind randomized trial with parallel control to demonstrate the safety and~     immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is~     to determine the safety and immunogenicity of acellular Tdap vaccine.~      The experimental group will receive acellular Tdap vaccine and the control group will~     receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned,~     which will be administered by the same route (intramuscular) and at the same dose (0.5 ml)~     that the vaccine.~   "
123010|NCT01445730|"~     High fructose intake is increasingly recognized as causative in development of prediabetes,~     metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying~     fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In~     contrast to metabolism of glucose, the breakdown of fructose leads to the generation of~     metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both~     fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be~     activated by fructose independently of insulin. However, it is still controversial whether~     fructose consumption increases DNL in man to the extent that it induces metabolic~     disturbances. Animal studies have shown that also the adipose tissue is responsive to~     fructose feeding fructose, and that high fructose-feeding induces insulin resistance and~     inflammation in the adipose tissue. The role of intestinal insulin resistance in~     fructose-induced dysmetabolism has not been studied in detail. The critical question is~     whether the metabolic disturbances are induced by calorie excess or by fructose per se.~   "
123011|NCT01445717|"~     This study evaluates the use of a new method of growing and detecting Group B streptococcus~     in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the~     advantage of detecting GBS in less than 6 hours, with less cost, and the potential of~     allowing antibiotic sensitivities to be performed.~   "
123012|NCT01445704|"~     The purpose of this study is to evaluate the success of daily supplementation of multiple~     probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight~     loss in the RNYGB (Gastric Bypass) weight loss population.~   "
123013|NCT01445691|"~     The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid~     (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time.~     When the investigators remove the tumor from your brain, it is important that they remove~     all of the tumor and not remove parts of normal brain. Sometimes this can be difficult~     because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the~     tumors glow red under blue light. This may make it easier for your doctor to take out all of~     the tumor from your brain. The purpose of this study is to:~        -  Make sure that 5-ALA helps the doctor remove more of the tumor.~        -  Make sure 5-ALA does not cause any side effects.~      If you do not want to participate in this study, your doctor(s) will still do their best to~     remove all of the tumor in your brain. Whether or not you join this study will not change~     your treatment for your brain tumor.~   "
123014|NCT01445678|"~     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of~     CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus~     meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections~     (cIAI).~   "
123015|NCT01445652|"~     The purpose of this study was to evaluate the relative benefits of daily disposable contact~     lenses versus spectacles in young adults.~   "
123016|NCT01445639|"~     Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent~     sedation and analgesia without respiratory depression. Dexmedetomidine has been used in~     critically ill medical, surgical, and pediatric patients. No study has been designed~     specifically to evaluate dexmedetomidine uses in the neurocritical care population. The~     primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic~     analgesia and sedation in patients after intracranial surgery.~   "
123020|NCT01445587|"~     This is a single arm, open-label, Phase Ib/II study to evaluate the safety,~     pharmacokinetics, pharmacodynamics, and efficacy of the oral AKT inhibitor, GSK2110183, when~     administered to subjects with proteasome inhibitor refractory multiple myeloma (MM). During~     Part 1 of the study, GSK2110183 will be administered to subjects in sequential~     Pharmacokinetic (PK) Cohorts on a continuous daily dosing schedule in 21-day cycles until~     one of the Treatment Discontinuation Criteria is met. The PK Cohorts will characterize the~     PK of GSK2110183 in plasma and urine as well as determine the Recommended Phase 2 Dose~     (RP2D) of GSK2110183. The RP2D will be that dose that provides adequate PK exposure and~     biologic activity without exceeding the maximum tolerated dose (MTD) in MM subjects as~     defined in the current study. In Part 2 of the study, the RP2D will be further evaluated~     using a flexible 2-stage design with a stopping rule to allow for early termination based on~     lack of efficacy at the end of Stage 1. The first stage will accrue 20 subjects who will~     receive GSK2110183 at the RP2D. If a clinical response is observed in at least 1 subject in~     Stage 1, the study will proceed to Stage 2 and 20 additional subjects will be enrolled.~     GSK2110183 will be administered in Part 2 (Stage 1 and Stage 2) on a continuous daily dosing~     schedule in 21 day cycles until International Myeloma Working Group criteria for progression~     are met, at which point the subject will proceed to GSK 2110183 + bortezomib salvage therapy~     provided they meet the additional eligibility criteria for this phase of the study.~     GSK2110183 and bortezomib will be continued until one of the Treatment Discontinuation~     Criteria is met.~      Exploratory PK/PD analyses may be performed to examine the potential relationships between~     GSK2110183 pharmacokinetics and pharmacodynamic biomarkers.~   "
123021|NCT01445561|"~     Background:~      - Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High~     dose interleukin-2 has been used to treat different types of cancer and immune system~     disorders. However, it can cause frequent and often serious side effects at the doses~     currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose)~     was previously tested in cancer patients and stem cell transplant recipients. The study~     observed important immune changes and minimal side effects in those patients. Researchers~     want to test the healthy immune system's responses to very low doses of interleukin-2 to~     better understand how the drug works.~      Objectives:~      - To study the effects of very low doses of interleukin-2 on healthy volunteers.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine samples.~        -  Participants will receive one of two possible very low doses of interleukin-2 every day~          for 5 days.~        -  Blood samples will be taken twice before the first dose, 1 day after the first dose,~          and before the next three doses. Followup blood samples will be taken on Days 7, 14,~          and 28 after the first dose.~   "
123022|NCT01445548|"~     This study will determine whether a drug called sirolimus is safe to give to people with~     geographic atrophy (GA) and if it can help preserve vision in patients. GA is an advanced~     form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part~     of the retina at the back of the eye needed for sharp, clear vision. There are two types of~     AMD, wet and dry. In dry AMD, cells in the macula die.~      GA may be partially caused by inflammation. Sirolimus helps prevent inflammation and~     therefore may help people with GA. Researchers want to see whether sirolimus can help~     prevent vision loss in people with GA.~      People at least 56 years of age who have GA related to AMD in both eyes may be eligible for~     this study.~      This study requires at least 8 visits to the National Eye Institute over 1 year. Study~     visits will be every 2 months for 1 year.~      Participants will undergo the following procedures:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and eye exams. One eye will be selected as the study eye to~          receive the sirolimus injections.~        -  Participants will have a sirolimus injection into the study eye at the first visit and~          every 2 months thereafter unless contraindicated. There will be a follow-up eye exam 1~          month after the first injection.~   "
123023|NCT01445535|"~     Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs~     may be more effective if given by continuous infusion into the vein rather than by the~     standard method of rapid intravenous injection. One such combination of six chemotherapy~     drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain kinds~     of cancer. Recent evidence also indicates that the effects of chemotherapy may be improved~     by combining the treatment with monoclonal antibodies, which are purified proteins that are~     specially made to attach to foreign substances such as cancer cells. This protocol is~     specifically for adults with the types of cancer known as T-cell and NK-cell lymphomas, who~     have never received chemotherapy previously. The additional monoclonal antibody in the~     study, called siplizumab, has been manufactured to attach to the CD2 protein contained in~     these types of tumors.~      Study volunteers will need to undergo an initial period of evaluation that may take up to 3~     weeks and may be done on an outpatient basis. Evaluation may include some or all of the~     following tests: blood and urine tests, tests of lung and heart function, lumbar punctures~     to take samples of cerebrospinal fluid, magnetic resonance imaging (MRI) or computerized~     tomography (CT) scans, full-body positron emission tomography (PET) scans, bone marrow~     biopsies, and biopsies of suspected tumor areas.~      During the study, patients will receive EPOCH-R chemotherapy, which includes the following~     drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The~     additional drug, siplizumab, will be given by IV infusion on the first day of treatment over~     several hours. When the siplizumab IV infusion is complete, the drugs doxorubicin,~     etoposide, and vincristine will each be given by continuous IV infusion over the next 4 days~     (that is, continuously for a total of 96 hours). When this infusion is completed, the drugs~     rituximab and cyclophosphamide will be given by IV infusion over several hours on Day 5.~     Prednisone will be given by mouth twice each day for 5 days. Patients may be given other~     drugs to treat the side effects of chemotherapy and to prevent possible infections.~      The siplizumab-EPOCH-R therapy will be repeated every 21 days, which is known as a cycle of~     therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles~     (approximately weeks 12 and 18) of siplizumab-EPOCH-R, study researchers will perform blood~     tests and CT/MRI scans on all patients to assess their response to the treatment.~   "
123024|NCT01445522|"~     Background:~        -  Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the~          treatment of certain cancers. It works by causing DNA damage, resulting in cell death,~          including cancer cells.~        -  ABT-888 is an experimental drug that has been given to a small number of patients. It~          works by preventing DNA repair in tumor cells.~      Objectives:~        -  To test the safety of the combination of ABT-888 and CP, and to determine the dose of~          each drug that can be given together to patients with cancer.~        -  To see how the body handles ABT-888 when given together with CP~        -  To evaluate the anti-tumor response of the drug combination.~      Eligibility:~        -  Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic~          leukemia) whose disease does not respond to standard treatments.~      Design:~        -  Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose~          level assigned to the individual patient.~        -  Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP~          for 14 days only.)~        -  Patients undergo tests and procedures periodically during the study, including:~        -  Clinic visit and physical examination at the beginning of each cycle~        -  Blood and urine tests, electrocardiogram, measurement of vital signs~        -  CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment~        -  Tumor biopsies (optional)~        -  Bone marrow aspiration and biopsy~   "
123077|NCT01444716|"~     The goal of this clinical research study is to learn if ofatumumab can help to control CLL.~     The safety of this drug will also be studied.~      Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the~     leukemia cells to die.~   "
123025|NCT01445509|"~     Background:~        -  Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor~          called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which~          promote and stimulate blood vessel formation and cancer growth and spread.~        -  Using the two drugs in combination may provide a more effective cancer treatment than~          either drug used alone.~        -  Both drugs have been approved by the Food and Drug Administration for different cancer~          types, but their use in combination sis experimental.~      Objectives:~      - To determine the highest doses of the combination of dasatinib and bevacizumab that can be~     safely given to patients with different cancers and to find out what effects, good and bad,~     these drugs may have on the patient and the disease.~      Eligibility:~      - Adult patients with an advanced solid tumor cancer that cannot be treated successfully~     with standard therapies.~      Design:~        -  Patients in Group 1 receive dasatinib and bevacizumab together throughout the study.~          The dose is increased in successive groups of three to six patients until the optimum~          safe dose is determined. Patients take dasatinib by mouth once a day and receive~          bevacizumab as an infusion through a vein once every 2 weeks in 28-day treatment~          cycles.~        -  Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab~          for cycle one, and then both drugs for all subsequent cycles. The drug doses are based~          on the optimum doses found in Group 1 patients.~        -  Patients have a physical examination and blood and urine tests every 2 weeks for cycles~          1 and 2, and then every 4 weeks for the duration of treatment.~        -  Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks~          to monitor the cancer s response to treatment.~        -  Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the~          first treatment cycle, and 2 weeks into the second cycle.~        -  Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before~          treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI~          test uses a special non-radioactive dye that shows blood flow in a certain part of the~          body.~   "
123026|NCT01445483|"~     Background:~        -  There are no standardized sets of tests to measure changes in neuropsychological~          functioning in patients treated for brain metastasis (cancer that has spread beyond the~          original site to the brain).~        -  Neuropsychological function has an important effect on quality of life and should be~          included when determining treatment options.~      Objectives:~        -  To find out if there is a change in patients cognitive (thinking) and daily functioning~          after standard radiation treatment for brain metastasis that can be measured with~          tests.~        -  To see if any changes on these tests are related to patients response to radiation~          therapy.~      Eligibility:~      - Patients 18 years of age or older who have cancer that has spread to the brain.~      Design:~        -  Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days~          a week. Some patients may require stereotactic radiosurgery (an additional boost of~          radiation therapy to specific sites of brain metastasis).~        -  Patients have the following evaluations before and after treatment to determine changes~          in cognition and functioning:~        -  Neuropsychological testing to measure cognitive (thinking) abilities like memory,~          attention, processing speed, and reading, and fine motor skills.~        -  Questionnaires to assess quality of life and daily living skills.~        -  Patients have MRI scans and blood and urine tests.~        -  At the completion of radiation treatment, patients return to the clinic for follow-up~          visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination,~          MRI of the brain, neuropsychological testing and assessments of quality of life and~          daily living skills.~   "
123027|NCT01445444|"~     The purpose of the current study is:~        1. To evaluate the effectiveness of a habit reversal training (HRT) approach for children~          ages 7 to 17 years of age inclusive with a diagnosis of trichotillomania.~        2. To explore factors that may relate to symptom severity, treatment outcome, and~          psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional~          regulation).~   "
123028|NCT01445431|"~     Among adult patients with chronic kidney disease undergoing hemodialysis, what is the~     efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic~     moisturizer for uremic xerosis?~   "
123029|NCT01445418|"~     Background:~        -  Carboplatin is approved by the Food and Drug Administration to treat cancer.~        -  AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a~          protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that~          process.~      Objectives:~        -  To determine the optimum doses of AZD2281 and carboplatin that can safely be used in~          patients with breast and ovarian cancer.~        -  To evaluate the response of the tumor to the drug combination and determine the side~          effects of the treatment.~      Eligibility:~      -Patients 18 years of age or older with breast or ovarian cancer who have a family history~     of cancer or who have a BRCA1 or BRCA2 mutation.~      Design:~        -  In this dose escalation study, the first small group of patients receives the smallest~          study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher~          doses of first AZD2281 and then carboplatin as long as the preceding group has not~          experienced unacceptable side effects. When the highest safe dose is determined,~          additional patients receive that dose.~        -  Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day~          every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue~          until it is no longer beneficial.~        -  Evaluations during treatment include the following:~        -  Physical examination 1 week after starting treatment and then every 3 weeks.~        -  Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks.~        -  CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the~          tumor.~   "
123030|NCT01445405|"~     Background:~      Bortezomib acts on molecules in head and neck cancer cells that are important for the cells~     growth and survival. The drug may help make the cancer more sensitive to radiation and other~     chemotherapy drugs.~      Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation~     treatment in patients with head and neck cancer in clinical trials.~      Cisplatin has shrunk head and neck cancers and improved treatment response and survival when~     combined with radiation treatment.~      Objectives:~      To determine the highest safe dose of bortezomib when combined with cetuximab without or~     with cisplatin and with radiation in patients with advanced head and neck cancer.~      To examine the benefits and side effects of these drug combinations with radiation in~     patients with advanced head and neck cancer.~      Eligibility:~      Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not~     previously had neck radiation.~      Design:~      Patients will be assigned sequentially to one of two treatment groups: Group A receives~     bortezomib and cetuximab beginning the week before, and for the duration of, radiation~     therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and~     for the duration of, radiation therapy.~        -  Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the~          first dose and then over 1 hour for subsequent weekly doses.~        -  Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for~          2 weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during~          radiation.~        -  Cisplatin is given in once a week as a 1-hour IV infusion~        -  Radiation therapy is given 5 days a week for 7 to 8 weeks.~      Post-treatment follow-up:~        -  Until 2 weeks after treatment ends, patients are followed once a week including a~          physical examination, review of treatment side effects, and blood tests.~        -  For 2 months after treatment ends, patients may need to return to the hospital for~          medical evaluation and supportive care, depending on their condition.~        -  8-weeks after treatment ends, patients return for evaluation with a history and~          physical examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or~          MRI scan, or both, of the neck and chest; and, if indicated, a PET scan....~   "
123075|NCT01444742|"~     The goal of this clinical research study is to learn if clofarabine when given in~     combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the~     disease could not be controlled with standard therapy. The safety of this treatment will~     also be studied.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer~     cells and stop the DNA from repairing itself.~   "
123031|NCT01445392|"~     Background:~      Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin.~     However, the benefits of this treatment are limited, and in most treated patients the~     disease continues to worsen.~      SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a~     certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a~     bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the~     cancer cells, allowing the toxin to enter and kill the cells.~      Objectives:~      To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable~     in patients with mesothelioma.~      To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not~     cause unacceptable side effects).~      To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients~     tumors.~      To learn how the body breaks down SS1(dsFV)PE38.~      Eligibility:~      Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot~     be cured with surgery, and have not had prior treatment with chemotherapy.~      Design:~      Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:~        -  Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin.~        -  Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with~          SS1(dsFV)PE38.~        -  Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of~          patients are given SS1(dsFV)PE38 at a certain dose level. If the first group~          experiences no significant side effects, the next group a higher dose. This continues~          in succeeding groups until the maximum tolerated study dose (highest dose that patients~          can be given safely) is determined.~      Continuing standard treatment with additional cycles of pemetrexed and cisplatin.~      Evaluations during the treatment period:~        -  Physical examination, including vital signs and body weight checks, and pregnancy test~          for women who can become pregnant.~        -  Questions about medications and side effects.~        -  Blood and urine tests.~        -  Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests,~          pulse oximetry, performance of daily activities and quality-of-life questionnaires.~      Post-treatment evaluations:~        -  Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease~          assessment.~        -  End-of-study visit for blood tests, vital signs and weight measurements, disease~          assessment, electrocardiogram, pregnancy test for women who can become pregnant~   "
123032|NCT01445379|"~     This study will examine the safety and efficacy of ipilimumab-an experimental cancer~     treatment drug used to boost immune response-in children, adolescents, and young adults.~     Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and~     has been tested in adults for a variety of cancers and has shown responses in some research~     studies. Because ipilimumab has not been tested in children, adolescents, or young adults,~     it is considered an experimental drug. The purposes of this research study are to determine~     the highest safe dose of ipilimumab for children, adolescents, and young adults with solid~     tumor cancers; examine its effectiveness and possible side effects; and better understand~     how the body and the immune system process it over time.~      Candidates must be between 2 and 21 years of age and must have solid malignant tumors that~     have been resistant to standard therapy. Volunteers will be screened with a medical history,~     a clinical examination, and computerized scans such as magnetic resonance imaging (MRI).~     Participants must have completed their last dose of chemotherapy, radiation, chemotherapy,~     or antibody or investigational therapy at least four weeks prior to enrollment.~      During the study, participants will receive an intravenous dose of ipilimumab once every~     three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital~     signs will be monitored while the medicine is infusing and several times in the first 24~     hours after the first dose (requiring a hospital stay during that time). If the participant~     is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be~     received on an outpatient basis. Blood and urine tests will be given on a regular basis~     during these cycles. After four cycles, participants whose tumors do not grow and who do not~     have unacceptable side effects will continue to receive ipilimumab every three months to~     maintain the current condition, until researchers conclude the study.~   "
123033|NCT01445366|"~     This is a prospective cross-over study including 10 stable hemodialysis patients with~     chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis~     sessions at midweek.~      During one session, the patient will be dialyzed during 4 hours with high volume post~     dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a~     blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.~      During the other midweek session, the patient will be dialyzed during 8 hours with high flux~     hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of~     200mL/min and a dialysate flow of 500mL/min.~      The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post~     dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample~     will be drawn from the inlet and outlet line.~      At the dialysate outlet line, partial dialysate collection is performed at the outlet line.~      Blood and dialysate samples will be analyzed for a broad range of retention solutes like~     small and water soluble solutes, middle molecules, and protein bound solutes.~      These data will be further used to calculate solute removal and evaluate any differences~     between the solute removal during high volume post dilution HDF and high flux HD.~   "
123034|NCT01445340|"~     Background:~        -  Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The~          cancer cells are found in red, scaly patches that may sometimes itch.~        -  Early-stage CTCL is usually treated with topical therapies, which may lose~          effectiveness over time and have adverse effects, such as risk of secondary skin~          cancers and difficulty of use.~        -  Romidepsin is an experimental drug that, given through a vein, has improved CTCL in~          some patients with later stages of the disease.~        -  A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.~      Objectives:~        -  To determine the highest tolerated dose of topical romidepsin that can be given to~          patients with early-stage CTCL.~        -  To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.~        -  To determine how the body handles topical romidepsin.~      Eligibility:~      -Patients 18 of age and older with early-stage CTCL.~      Design:~        -  Study Part 1: Successive groups of 3 patients are treated with increasingly higher~          concentrations of topical romidepsin until the highest tolerated dose is found.~        -  Study Part II: The highest tolerated dose, as determined in Part I, is applied to~          larger areas of skin in another group of patients.~        -  All study participants apply the study medicine to their skin three times a day for 4~          weeks.~        -  During treatment, participants are monitored at weeks 2 and 4 with a history and~          physical examination, blood tests, electrocardiogram, skin biopsies and photographs of~          the skin.~        -  After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood~          tests and to see how the study medication is affecting the body.~   "
123035|NCT01445327|"~     Background:~        -  Gastrointestinal cancers are among the most commonly diagnosed cancers in the United~          States.~        -  There are currently no tests to predict how patients with gastrointestinal cancers will~          respond to radiation therapy or which patients may develop side effects from treatment.~        -  Studies on tumor cells in the stool, urine, or blood from patients may provide valuable~          information that can be used to develop tests to determine which patients may need more~          or less aggressive therapy.~        -  Studies of other substances in the stool, urine, or blood from patients may provide~          valuable information that can be used to develop tests to determine which patients are~          likely to develop side effects from radiation treatments.~      Objectives:~        -  To collect blood, urine and stool specimens from patients with gastrointestinal cancers~          who will undergo radiation therapy.~        -  To study hormone and protein changes in these blood, urine and stool specimens before,~          during and after radiation treatment in order to develop a way to predict how~          gastrointestinal cancers will respond to radiation therapy and if patients with these~          cancers will develop side effects from radiation treatment.~      Eligibility:~      -Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus,~     stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an~     NCI protocol~      Design:~      Participants undergo the following procedures:~        -  Tumor biopsy: Before any treatment or at the time of surgery if it is the first~          treatment~        -  Urine collection: Before, during, and after treatment and at follow-up visits.~        -  Stool collection: Before, during, and after treatment and at follow-up visits.~        -  Blood collection: Before, during, and after treatment and at follow-up visits.~        -  Intestinal permeability assessment: Before any treatment, before radiation (if~          radiation is not the first treatment), 1 month after radiation is completed, and 3~          months after radiation is completed. This test determines how the patient s intestines~          are working to absorb sugar and may provide information about side effects from~          radiation treatments. Patients fast after midnight, then drink a small glass of sugars,~          and then do a 6-hour urine collection.~   "
123036|NCT01445314|"~     Background:~        -  People with chronic illness often are at risk for developing neurobehavioral problems~          due to effects of the disease or associated treatments. These problems may include~          cognitive impairments involving problem-solving, remembering things, paying attention,~          and understanding and using language, or emotional functioning or quality of life.~        -  The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group~          has collected data from neurobehavioral evaluations of infants, children, adolescents~          and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to~          collect data from patients enrolled in current protocols.~        -  The data from these evaluations, along with demographic and medical information are~          stored in an NIH computer database.~        -  Investigating the neurobehavioral functioning of patients with chronic illness is~          important for identifying and monitoring the effects of the disease and treatments over~          time, determining possible at-risk subgroups, evaluating response to therapy, and~          recommending educational and rehabilitative interventions.~      Objectives:~      -To learn about how certain illnesses or treatments may affect a person s cognitive~     abilities, emotional functioning and quality of life.~      Eligibility:~        -  Patients currently enrolled in NIH studies who are having neuropsychological testing or~          completing quality-of-life questionnaires as part of that study.~        -  Data obtained from infants, children, adolescents, and adults administered~          neurobehavioral assessments as part of a past or future NIH protocol.~      Design:~        -  This study does not involve any extra tests or questionnaires; it uses information~          collected from evaluations that subjects have already completed or will complete as~          part of other NIH studies.~        -  Information about participating patients that may help elucidate how cognitive~          abilities, emotional functioning, and quality of life are affected in people with~          chronic illness may be collected and stored.~   "
123037|NCT01445301|"~     This is a multicenter, randomized, single-blinded (investigator's blinded),~     active-controlled (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects~     with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO]~     3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the~     safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.~   "
123038|NCT01445288|"~     This study will analyze the effects of radiation given to children who have tumors of the~     central nervous system (CNS). Researchers want to learn more about changes in the quality of~     life that patients may experience as a result of radiation.~      Patients ages 21 and younger who have a primary CNS tumor and who have not received~     radiation previously may be eligible for this study. They will have a medical history and~     physical examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done,~     as well as a pregnancy test. Patients will complete neuropsychological tests, which provide~     information about their changes in functioning over time. An expert in psychology will give~     a number of tests, and the patient's parents or guardian will be asked to complete a~     questionnaire about the patient's behavior. Also, patients will be given a quality of life~     questionnaire to complete and vision and hearing tests. The radiation itself is prescribed~     by patients' doctors and is not part of this study.~      Magnetic resonance imaging (MRI) will give researchers information about the tumor and~     brain, through several scanning sequences . MRI uses a strong magnetic field and radio waves~     to obtain images of body organs and tissues. Patients will lie on a table that slides into~     the enclosed tunnel of the scanner. They will need to lie still, and medication may be given~     to help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes~     pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to~     reduce the noise. A contrast agent will be administered, to allow images be seen more~     clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI~     scans will be done 2 weeks after patients finish radiation therapy and again at 6 to 8~     weeks, 6 months, 12 months, and yearly. Also at those follow-up periods, patients will~     undergo similar procedures as previously, including blood and urine tests and~     neuropsychological testing. Patients can remain in this study for 5 years.~   "
123039|NCT01445275|"~     This research trial collects information about types of treatment and the cost of these~     procedures in women with elevated genetic risk for ovarian cancer who participated on the~     Gynecology Oncology Group (GOG)-0199 trial. Gathering information about women at elevated~     genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures~     and the cost of these procedures.~   "
123040|NCT01445262|"~     This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy~     data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation,~     prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets~     before.~   "
123041|NCT01445249|"~     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and~     is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this~     work. The purpose of this study is to compare two techniques: one using anatomical landmarks~     alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation~     to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques~     will be compared for reliability of postoperative analgesia.~   "
123042|NCT01445236|"~     Immunosuppressive drugs can be successfully withdrawn in a fraction of liver transplant~     patients. Specific peripheral blood gene expression markers can be employed to select~     patients with a high likelihood of being tolerant. In the current study the investigators~     propose to conduct a pilot non-randomized prospective study in which gradual weaning of~     immunosuppressive drugs will be offered to liver recipients exhibiting a favorable~     peripheral blood gene expression profile.~   "
123043|NCT01445223|"~     The present study aims to compare efficacy, side-effects, and treatment adherence of three~     different treatment regimens given to antiretroviral naïve HIV-1 infected patients.~     Treatment will be initiated in accordance with the Swedish National Guidelines. In the twice~     daily (BID) arm (1), which could be considered as a standard regimen at present,~     lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors~     (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor~     (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the~     non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs~     administrated QD. All drugs used in the study are licensed in the participating countries~     and patients will be followed as in clinical practice. Patients could optionally, after~     informed consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3~     weeks of treatment to asses the kinetics of viral decline after initiation of treatment.~   "
123044|NCT01445210|"~     The most useful method to manage pain after major ankle surgery is infusion of local~     analgesics with a catheter close to the sciatic nerve.~      Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified~     in the sciatic nerve) and the saphenous nerve.~      Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve~     catheter provide a better treatment of pain in comparison with a single injection nerve~     block. In addition cost-effectiveness of the two methods are compared.~      The 50 patients of the trial are randomized in clusters of ten. We intend to do a~     preliminary analysis of the data from the first 40 patients. However, it is not an interim~     analysis. Fifty patients will be included independent of the result of the preliminary~     analysis. The random allocation of the last 10 patients will also be double-blinded.~   "
123045|NCT01445197|"~     This is a clinical study to investigate how well Biostate works in treatment of male~     patients below the age of 12 years who have a clotting factor deficiency that is aggravated~     by the development of antibodies. The antibodies are directed against the clotting factor~     that is given for replacement therapy and usually make therapy unsuccessful. The treatment~     used in this study is called immune tolerance therapy.~   "
123047|NCT01445158|"~     Background:~        -  Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major~          organ transplant in the United States.~        -  Pediatric 1st degree stem cell donors can experience a variety of psychological~          difficulties before and after donation with those who feel they are not adequately~          prepared for possible complications following stem cell donation and transplant~          describing negative emotions.~        -  The importance of preparation for children undergoing medical procedures has long been~          recognized in the field of pediatric psychology~      Objectives:~        -  To assess how prepared pediatric donors are for stem cell donation by assessing their~          knowledge about stem cell transplants, and to assess their anxiety at different stages~          of the donation process.~        -  To assess the effectiveness of a workbook and a board game as tools for conveying~          information on donation and transplantation to donors.~        -  To identify donors who may require additional preparation before stem cell collection.~        -  To explore the relationship between donor knowledge and anxiety symptoms.~      Eligibility:~      -Stem cell donors ages 10 to 26 years of age~      Design:~        -  Participant s baseline knowledge and anxiety are evaluated.~        -  Participant s knowledge is reassessed and anxiety evaluated following an information~          session with the research nurse and doctor about the procedures for stem cell donation~          and discussion of the consent form for the transplant protocol.~        -  Participants are separated into two groups. Donors 10 to 15 years of age play a board~          game; those 16 to 26 years of age are given a workbook on stem cell transplant.~        -  Participants knowledge and anxiety are reassessed within 24 hours after working with~          the educational materials and again 1 month later.~   "
123048|NCT01445145|"~     Background:~        -  Few resources exist for helping adolescents and young adults with cancer or HIV disease~          understand their changing physical, emotional and social needs when treatment is no~          longer effective.~        -  An advance directive document called Five Wishes has had particular success with the~          adult population because of the consideration of personal, emotional and spiritual~          needs in addition to medical and legal concerns.~      Objectives:~      -To learn which questions in Five Wishes are useful for adolescents and young adults and to~     then create a new document that reflects the issues they feel are most appropriate for~     people with cancer or HIV disease.~      Eligibility:~      -Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease~     acquired perinatally or early in life and enrolled in an active NIH treatment protocol.~      Design:~        -  Stage 1: Participants go through each question in Five Wishes and respond to whether~          they feel the questions are useful.~        -  Stage 2: Participants are asked to compare each question from Five Wishes to a newly~          developed document based on the feedback received during first stage of the study.~        -  Participants are enrolled for either Stage 1 or Stage 2 depending on the date they~          enter the study.~   "
123049|NCT01445132|"~     Background:~        -  After allogeneic (donor) stem cell transplantation, a new immune system grows in the~          patient from the transplanted donor stem cells and lymphocytes (type of immune cell).~          Donor lymphocytes, unlike the patient s own lymphocytes, often can recognize the~          patient s tumor cells as being foreign and destroy them.~        -  It is thought that tumor shrinkage after stem cell transplantation is the result of~          donor T lymphocytes, or T cells. Some studies show that patients with tumors that have~          T cells are better able to keep tumor growth in check.~        -  Patients who have had donor stem cell transplantation may have donor T cells in their~          tumors that can recognize and fight their cancer. Compared with donor T cells taken~          directly from the donor and infused into the patient, donor T cells found in patients~          tumors may be specific for the cancer cells and thus better able to attack tumor. Also,~          because the T cells found their way to the tumor, they may be less likely to recognize~          and attack non-tumor tissues than the T cells given in donor lymphocyte infusions.~        -  The T cells may be especially effective at controlling tumor if they are given an~          additional stimulus to become active. Costimulation is the name of the body s natural~          process for providing an extra stimulus, and can be performed on cells in the~          laboratory. Costimulation can produce large numbers of activated cells that may be able~          to attack cancer cells and shrink tumors.~      Objectives:~      -To evaluate the ability of lymphocytes found in tumors from patients who have received~     donor stem cell transplants to control their tumor growth.~      Eligibility:~      -Patients between 18 and 75 years of age with a B-cell cancer that has continued to grow or~     recurred after remission following allogeneic stem cell transplantation. This includes~     patients who have received transplants from unrelated donors and cord blood.~      Design:~        -  Immune cells are collected from patients blood and blood from their stem cell donor.~        -  Patients undergo surgery to remove their tumor and a small piece of skin. In the~          laboratory, donor T cells are isolated from the tumor and costimulated to expand the~          number of cells and activate them.~        -  The expanded, activated T cells as infused into the patient.~        -  Patients have a needle biopsy and possibly surgery to remove a sample of remaining~          tumor for research studies.~        -  Patients are followed at the NIH clinic 48 hours after the cell infusion, and again at~          1, 2, 4, 8 and 12 weeks after the infusion. Tumor size is monitored every month with CT~          scans, and possibly also with a PET or bone marrow aspiration and biopsy, for the first~          3 months after the cells are infused. Thereafter, visits are less frequent (every 3~          months, then every 6 months, and then yearly) during a minimum 5-year follow-up.~   "
123050|NCT01445119|"~     This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug~     that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients~     who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of~     cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and~     accumulation, requiring a blood supply. Research shows that brain tumor cells can produce~     substances that stimulate new blood vessel formation. This study will look into whether the~     combination of drugs can stop that process.~      Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast~     feeding, and who do not have serious diseases may be eligible for this study. About 96~     patients will participate for 1 year. They will have a physical examination, give blood and~     urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed~     tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may~     also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to~     distinguish a live tumor from a dying one. Researchers are studying patients taking a~     certain type of antiseizure medicine and patients who are not taking it because some~     antiseizure medicines may change the way the body handles a drug such as Enzastaurin. There~     will be two groups of participants, with 16 to 48 each. Group A is not taking~     enzyme-inducing antiseizure drugs, and Group B is taking such drugs. In Groups A and B are~     four dose levels, with 4 to12 patients at each level. Patients' doctors will tell them which~     group they belong to and how much Enzastaurin and Carboplatin they will take. Treatment~     consists of Enzastaurin every day for 5 weeks in Cycle 1 only and for 4 weeks beginning with~     Cycle 2 (each 4-week period as a cycle). Patients take Enzastaurin within 30 minutes after a~     meal. History, physical, and neurological examinations are repeated at the end of Cycle 1~     and then every 4 weeks. Patients will have a repeat head MRI or CT scan before each cycle.~     If they tolerate the drugs without serious side effects and the tumor is not growing, they~     may continue with another cycle of Enzastaurin, taking the tablets every day, and~     Carboplatin being infused on Day 8 of Cycle 1 and on Day 1 of each additional cycle. Routine~     lab tests are done regularly. Patients will continue the 4-week cycles of treatment for as~     long as they have no serious side effects and there are no signs of tumor growth. Side~     effects of Enzastaurin may be fatigue, constipation, cough, and nausea. In men, there may be~     a decrease in sperm count. Carboplatin can lead to low counts in blood cells and platelets,~     and there may also be an allergic reaction. Vomiting is a likely side effect. At injection~     sites, there may be redness, swelling, and pain.~      This study may or may not have a direct benefit for participants. However, information~     gained may help the sponsor of the study, Eli Lilly and Company, and may help patients in~     the future who have gliomas.~   "
123051|NCT01445106|"~     Background:~        -  The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes~          chemotherapeutic resistance and confers a poor prognosis for many types of cancers.~        -  Several inhibitors of the pathway are being developed as cancer therapeutics. However,~          the process of de novo drug development takes years, and is often curtailed due to~          diminished activity and/or unforeseen toxicities in clinical trials.~        -  One approach to expedite the development of new cancer therapies is to test drugs that~          are already approved for other indications.~        -  Our group has shown that nelfinavir, an orally available FDA-approved HIV-1 protease~          inhibitor used to treat HIV/AIDS, can inhibit endogenous Akt and growth factor receptor~          induced Akt activity in cancer cells.~        -  Importantly, nelfinavir demonstrates dose-dependent cytotoxicity in every cell line in~          the NCI 60 cell line panel at plasma concentrations attainable in human plasma, is~          profoundly effective in cancer cell lines that have been selected to become resistant~          to standard therapies, and inhibits tumor growth in-vivo.~      Objectives:~        -  Because an MTD with nelfinavir has not been observed in prior phase I studies with HIV~          patients, the objectives of the Phase I design will be:~        -  To establish the MTD and dose limiting toxicity for this drug in patients with solid~          Tumors.~        -  To correlate nelfinavir pharmacokinetics with baseline activity of CYP3A4 as assessed~          by measuring midazolam clearance.~        -  To preliminarily explore the biological and clinical effects through a series of~          correlative studies involving analysis of blood and tissue across patients throughout~          the study.~      Eligibility:~      -Adults with solid tumors who are refractory to, or have relapsed after receiving, standard~     front-line chemotherapies are eligible.~      Design:~        -  Patients will receive nelfinavir beginning at the FDA-approved dose for HIV patients~          (1250 mg po bid).~        -  Dose escalations will occur for 6 dose levels i.e. cohorts, or until the MTD is~          reached.~        -  Up to 45 patients are expected to be enrolled.~        -  Staging CT scans will be performed every two cycles.~   "
123052|NCT01445080|"~     Background:~        -  Sorafenib is an experimental anti-cancer drug that works by blocking proteins thought~          to be important for tumor growth. It has blocked the growth of tumors in test tubes and~          in some animal models.~        -  Sorafenib is approved for the treatment of advanced kidney cancer.~        -  This is the first time sorafenib is being tested in children with cancer.~      Objectives:~        -  To determine the highest dose of sorafenib that can be safely given to children and~          young adults with cancer.~        -  To determine the side effects and benefits, if any, of sorafenib in children and young~          adults with cancer.~        -  To study how the body handles sorafenib and the drug's effects on cells and proteins in~          the blood.~      Eligibility:~      -Patients between 2 and 21 years of age with solid tumors or leukemias that do not respond~     to standard treatment.~      Patients between 2 and 21 years of age with AML and FLT3-ITD mutation for Part C of the~     study.~      Design:~        -  Patients take sorafenib tablets every day about every 12 hours in 28-day treatment~          cycles for a maximum of 24 cycles.~        -  The dose is increased in succeeding groups of 3 to 6 children until serious side~          effects occur. Subsequent patients then receive the drug at lower doses.~        -  Patients have a physical exam, blood and urine tests, and CT or MRI scans periodically~          to monitor safety and treatment effects. Leukemia patients also have bone marrow~          aspirates. Patients with a solid tumor may have an MRI. Children whose bones are still~          growing have X-rays of the lower legs periodically to monitor bone structure.~        -  Patients have additional blood studies to determine the amount of sorafenib in the~          blood, the effect of the drug on proteins and cells in the blood, and genetic~          differences that affect how individuals respond to the drug.~   "
123053|NCT01445067|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during~     migraine and non-migraine condition.~   "
123076|NCT01444729|"~     An agreement has been made to conduct a post-approval commitment study that provides~     supplementary information relating to the use of Xiapex® as well as other~     non-pharmacological treatments for Dupuytren's contracture by health care professionals in a~     real world clinical setting.~   "
123054|NCT01445054|"~     Background:~        -  Some breast cancer cells have specific proteins (receptors) on their surface that make~          the tumor grow faster than normal cells. One of these receptors is called HER2/neu.~        -  An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the~          cancer cell.~        -  Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has~          been attached to a tiny amount of Herceptin.~      Objectives:~      -To see if Indium-Herceptin provides information about the characteristics of the breast~     cancer in women whose tumors express HER2/neu and those whose tumors do not.~      Eligibility:~      -Women 18 years or older with primary or metastatic breast cancer who have not received~     treatment with herceptin for at least 6 months before enrollment into the study.~      Design:~        -  Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu~          status.~        -  Patients have a physical examination and review of medical records.~        -  Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma~          camera that detects the radioactivity in the Indium-Herceptin.~        -  Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine~          the best time to image after injection of Indium-Herceptin.~        -  Blood samples are obtained every day of scanning to monitor the effects, if any, of the~          Indium-Herceptin and to see how fast the agent leaves the body.~   "
123055|NCT01445041|"~     Further study details as provided by Duke University:~      Purpose: To evaluate the feasibility and safety of collecting and infusing autologous~     umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS).~      Study Rationale and Hypotheses: The major goal of this study is to determine whether~     infusion of autologous UCB cells in neonates with hypoplastic left heart syndrome is~     feasible and safe. The rationale for the study and for the potential benefit of UCB is based~     upon the following hypotheses:~        1. Infants with HLHS have significant neural injury evidenced from both prenatal and early~          antenatal brain MRI findings and infusion of UCB cells may lessen neural injury.~          Although the exact mechanism is unknown, UCB cell infusion may ameliorate neural injury~          via paracrine and anti-inflammatory effects that enhance post injury repair and may~          promote endogenous functional compensation of other cortical areas resulting in~          significant clinical improvements.~        2. UCB cells may also enhance cardiac function, minimize scar formation, and reverse~          detrimental remodeling after cardiac injury.~   "
123056|NCT01445028|"~     Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an~     important cause of retinal re-detachment. The purpose of this study is to evaluate the~     effect of oral isotretinoin, which inhibits the growth of cells responsible for~     proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.~   "
123057|NCT01445015|"~     The study will utilize a stress management program delivered over 10 sessions that is~     hypothesized to result in decreased stress levels and improved coping strategies in an inner~     city adolescent asthma population. Participants will include adolescents ages 10-15 years~     with physician diagnosed asthma. The outcome measures will be obtained via psychosocial~     questionnaires and spirometry.~   "
123058|NCT01445002|"~     The study will evaluate the dose response of immunotherapy against grass pollen allergy~     using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:~        -  skin prick testing~        -  grass pollen inhalation challenge~        -  antibody responses. In addition, the safety of subcutaneous application of BM32 will be~          evaluated.~   "
123059|NCT01444989|"~     Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh~     colored to erythematous, these lesions often present with scaling or crusting in sun damaged~     regions of the body. While they are physically visible and often palpable, these changes can~     also result in psychosocial changes in patients, including embarrassment about their skin or~     reduction in leisure activities to avoid further sun exposure. At the same time, AKs are~     known to progress in a significant number of cases to squamous cell carcinoma (SCC), a~     concern in terms of its metastatic potential.~      The primary purpose of developing this questionnaire is to examine how well it can~     potentially identify patients with actinic keratoses. However, since AK is associated with~     significant detriment to quality of life for validity/reliability assessment, the~     investigators propose to give a compilation of four self-assessment questionnaires (not~     specific to AK but validated for skin health in general) to subjects with at least one~     actinic keratosis and age- and sex- matched participants without AKs, defined as the control~     population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as~     well as a questionnaire composed of items specific to predisposition to AKs to be able to~     better assess the discriminatory power of the questionnaire.~   "
123060|NCT01444976|"~     There is no ideal sedation technique that can be used during Transesophageal~     Echocardiography (TEE), and the data concerning the effects of available sedation techniques~     on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at~     comparing the effects of sedation through hypnotherapy with medical sedation achieved by~     midazolam on HRV.~   "
123061|NCT01444924|"~     This study is a single-center, randomized, placebo-controlled, double-blind clinical trial.~     The purpose of this study is to evaluate the impact of pre-operative transverses abdominis~     plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for~     gynecologic cancers.~   "
123062|NCT01444911|"~     This is a randomized controlled trial designed to evaluate the effect of the Vaginal~     Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage~     and a water based lubricant, on sexual dysfunction, compared to the current standard care~     for women with no evidence of disease after treatment for gynecologic cancers.~      In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients~     are generally asked about sexual function. Those women who report sexual dysfunction will be~     given the option to enroll in the study. After enrollment, the Female Sexual Function Index~     (FSFI) and other quality of life surveys will be administered at baseline. The participants~     will be randomized to either the control arm, composed of standard of care therapy for the~     physical components of sexual dysfunction, or the experimental arm (VRP).~      Throughout the study, the participants will undergo physical exams to assess the rate of~     improvement in their comfort with pelvic exams and changes in vaginal length. They will also~     be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of~     Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of~     improvement in sexual function and quality of life.~   "
123063|NCT01444898|"~     Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is~     a major source of morbidity and mortality in this population. It can lead to sleep apnea,~     cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that~     set it apart from other forms of obesity including insatiable appetite and food-seeking~     behavior which can be disruptive to home and school activities, and can cause severe social~     and psychological turmoil within families. PWS is also associated with unique hormonal~     abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the~     stomach that stimulates food intake during a fast. It is hypothesized that the extremely~     high ghrelin levels in patients with PWS may cause or contribute to their insatiable~     appetite. Exenatide, a medication used in the treatment of type 2 diabetes mellitus in~     adults, appears to suppress ghrelin levels and cause weight loss. It was designed to mimic~     glucagon-like peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and~     delays gastric emptying, among other effects. In the present study, the investigators will~     investigate the effects of a 6 month trial of exenatide in overweight adolescents with PWS.~     The investigators will quantify the changes in weight and body composition, as well as~     subjective measures of appetite, and concentrations of appetite-associated hormones. The~     investigators hypothesize that exenatide will improve weight, body composition, appetite,~     and plasma ghrelin levels during the treatment period.~   "
123064|NCT01444885|"~     The objective of this study is to investigate the efficacy and safety of Pletaal~     (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have~     an insufficient response to Amlodipine (Calcium channel blocker).~   "
123065|NCT01444872|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal~     dysfunction.~   "
123066|NCT01444859|"~     Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev~     Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent~     gastrointestinal symptoms.~   "
123067|NCT01444846|"~     Exposure to loud sounds can cause hearing loss. The purpose of this research study is to~     evaluate potential prevention of temporary changes in hearing that may occur after listening~     to music through an iPod or personal music player. We will measure temporary changes in~     hearing in subjects who listen to music and take either the study drug, SPI-1005, or a~     placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be~     taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione~     Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud~     sounds.~   "
123068|NCT01444833|"~     It is supposed that the significant metabolic effects (improvement of insulin sensitivity)~     of hypertension therapy with renin-angiotensin system (RAS) blockers in humans are mediated~     mainly via changes in abdominal adipose tissue. This project is aimed to confirm the~     hypothesis that increased concentrations of circulatory angiotensin II after angiotensin II~     receptor type I (AT1) blockade leads, via stimulation of angiotensin II receptor type II~     (AT2), to activation of adipogenesis and improvement of insulin sensitivity. Therefore, in~     hypertensive patients, the components of RAS and the parameters of insulin sensitivity on~     systemic (in plasma) and local (in adipose tissue and in its interstitial fluid) level will~     be studied. The main aim of the study is to identify the changes occurring in patient before~     and 6 months after the conversion of therapy from angiotensin converting enzyme (ACE)~     inhibitors to AT1 receptor blockers. Observed parameters will include gene expression of RAS~     components, parameters of insulin sensitivity, amount, and cellularity of adipose tissue~     obtained by biopsy, evaluation of direct production of cytokines and angiotensins into the~     interstitial fluid of fat tissue obtained by microdialysis and evaluation of the selected~     parameters in plasma.~   "
123069|NCT01444820|"~     In North America, around a quarter a million men are diagnosed with prostate cancer every~     year, and about 31,000 patients will die of their disease each year. Like other western~     countries, the incidence in Canada has increased due to an aging population and prostate~     specific antigen (PSA) screening. This has led to a significant demand on cancer care~     services for these patients. Prostate cancer patient with high risk features are more often~     treated with external beam radiation therapy (EBRT) plus two to three years of hormonal~     manipulation (luteinizing hormone-releasing hormone [LHRH] agonist). The most common~     radiation dose treatment for these patients is 74-78 Gy in 37-39 daily fractions of 180-200~     cGy for a treatment length of 7.5 weeks. This fraction size is believed to offer the best~     balance between desired tumour kill and unwanted normal tissue injury. Larger fraction sizes~     of more than 250 cGy (hypofractionation) are usually avoided for curative therapy because~     late reacting normal tissues. However prostate cancer cells have a unique radiobiology~     characteristic that suggests that hypofractionated radiotherapy is more efficient at~     prostate tumour killing than standard fractionation is, and will produce equivalent tumour~     control with a lower total dose and a shorter overall treatment time. Improved target~     localization techniques and conformal radiation therapy technology have allowed for dose~     escalation and hypofractionated radiation delivery in these circumstances with minimal or no~     increased toxicities.~      This trial is designed to determine whether high risk prostate cancer patients can be safely~     treated with a dose escalation hypofractionated radiation therapy in 5 weeks as opposed to~     the usual 7-8 weeks. These patients will be randomized to either the usual 76 Gy in 38~     fractions or 68 Gy in 25 fractions. 3D-Conformal Radiotherapy (3D-CRT) or Intensity~     Modulated Radiotherapy (IMRT) will be used to deliver the required radiation dose. Patients~     will also receive 28 months of androgen deprivation therapy (LHRH agonist). The primary~     outcome of the study is the acute and delayed toxicity and the secondary outcomes include~     biochemical failure, prostate specific mortality rate, bone metastases free survival, the~     prognostic and predictive value of several biological variables: presence of the PTEN~     deletion; expression of FoxP3 gene variants, topoisomerase 2α and cancer testis antigens;~     expression of X chromosome-linked micro-RNAs; presence of TMRSS2-ERG gene fusion and quality~     of life. It is planned to recruit 250 patients to this study.~   "
123070|NCT01444807|"~     Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to~     metastasectomy~   "
123071|NCT01444794|"~     The purpose of the protocol is to assess the responder rate as defined by the achievement of~     the primary goal from the Goal Attainment Scale following one botulinum toxin type-A~     (BoNT-A) injection cycle in accordance with routine practices.~   "
123072|NCT01444781|"~     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).~     The objectives are:~        -  To describe the antibody persistence to any antigen contained in the investigational~          DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose~        -  To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep~          B-PRP-T or Infanrix hexa™ vaccine.~        -  To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.~   "
123073|NCT01444768|"~     This study will evaluate various performance metrics of emergency department operations~     after the implementation of computerized physician order entry in an academic emergency~     department.~   "
123078|NCT01444703|"~     The investigators propose to test the hypothesis that pre-operative gargling with licorice~     reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal~     tubes compared to placebo after surgery through the first four post-extubation hours.~   "
123079|NCT01444690|"~     The purpose of this study is to assess the efficacy and tolerability of orally administered~     dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents~     presenting a disease and /or treatment related neuropathic pain.~   "
123080|NCT01444677|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after a~     single or multiple oral dose and to investigate the pharmacokinetic characteristics of~     MB12066 after a single or multiple oral dose.~   "
123081|NCT01444664|"~     The purpose of this prospective registry is to determine if patients harboring intracranial~     aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and~     blood plasma.~   "
123082|NCT01444651|"~     The purpose of this study is to find out if tadalafil can help overweight and obese people~     metabolize blood sugar more efficiently. The investigators also want to find out if 20~     mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The~     investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).~   "
123083|NCT01444638|"~     Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not~     have pre-spinal ultrasound examination of their back.~   "
123084|NCT01444625|"~     As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may~     increase microcirculation in skin, the purpose of the study is to investigate the chronic~     effect of flavanol-rich chocolate as an effective strategy to protect against the harmful~     effect of ultraviolet (UV) radiation.~   "
123085|NCT01444612|"~     Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism~     (PE), is a common post-operative complication. The effectiveness of fondaparinux compared~     with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery~     has been evaluated in database studies; however, the effectiveness of injectable~     anticoagulant medications following cancer-related surgeries in the practice setting has not~     been as well documented.~      The objective of this study is to analyze patient records from a national hospital database~     and compare the outcomes and costs between four types of injectable anticoagulant~     medications that were prescribed for the prevention of VTE following cancer-related surgery.~     This analysis will assess and quantify the outcomes, resource utilization, and cost of care~     for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The~     outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource~     utilization, and total costs (medical plus pharmacy).~      The source of data for this study is the Premier Perspective Database™. This hospital claims~     database links de-identified inpatient medical, pharmacy, and billing data from more than~     500 hospitals.~      This study is a retrospective cohort study that uses propensity score matching to adjust for~     the differences between the numbers of patients treated with each medication.~   "
123086|NCT01444599|"~     Recent clinical trials demonstrated that virtual histology-intravascular ultrasound~     (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease~     (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by~     VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area~     (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological~     significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI~     showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR~     represents functional severity of CAD. Few studies reported relevance between two tests. Aim~     of this study was to investigate whether the geometry and composition of lesions were~     different under FFR criteria.~   "
123087|NCT01444586|"~     This is a local, prospective, multicenter, non-interventional, observational study. Primary~     objective is to describe how in real life thromboprophylaxis is carried out after the~     discharge from a hospital in the patients who undergo elective knee and hip replacement and~     who receive Xarelto during hospitalization.~   "
123088|NCT01444573|"~     The investigators hypothesized that very lenient rate control is not inferior to strict or~     lenient rate control assessed by implantable continuous ECG monitor for preventing~     cardiovascular hospitalization and mortality in patients with long-standing persistent or~     permanent atrial fibrillation~   "
123089|NCT01444560|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in~     length, capable of post-transcriptional gene regulation. miRNAs bind to their target~     messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based~     on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in~     diverse developmental and cellular processes and linked to a variety of skin diseases and~     cancers. In the present study, the investigators examines the expression profiles of miRNA~     machinery components such as miRNA maturation and transport factors, microprocessor complex~     and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign~     melanocytic nevi.~   "
123090|NCT01444547|"~     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy~     with cisplatin and paclitaxel in esophageal cancer~   "
123091|NCT01444534|"~     The use of smartphones has increased substantially in recent years. Apart from making phone~     calls and sending short messages, these smartphones can also function as a computer on which~     one can download computer programs (the so-called applications). Health applications are~     increasingly developed and may be a new tool for education of patients and communication~     between healthcare providers and their patients, possibly contributing to a better care for~     patients with chronic diseases such as diabetes.~      Since the number of patients with diabetes mellitus and the number of people having a~     smartphone are rising, it is investigated whether applications on smartphones may be used to~     support lifestyle changes and self-monitoring of bloodglucose control, possibly leading to~     an improved glycaemic regulation in the group of patients with diabetes mellitus.~      Large randomized controlled trials have shown that a stable glycaemic regulation is~     important to reduce morbidity and mortality and to improve quality of life (QOL).~     Self-monitoring of blood glucose is an important tool to realize an optimal glycaemic~     regulation in patients with type 1 diabetes mellitus (T1DM). Apart from a good glycaemic~     control, QOL is essential in diabetic patients. A reduced QOL is associated with progression~     of the disease, worse intake of medication and an increased mortality in patients with T1DM~     and diabetes mellitus type 2.~      The increasing costs associated with the rising number of diabetic patients makes that~     research investigating cheaper alternatives in the care for patients with diabetes are~     needed. The switch from a written logbook to an electronic logbook may simplify the care for~     diabetes patients. By means of an application all variables (food intake, physical exercise,~     glucose day curves, insulin units, reminders to take medication) are integrated in one~     program. But whether this digitalisation also improves QOL of the patient is still unclear.~      Therefore the aim of this study is to evaluate the effect of a diabetes application on the~     (QOL) for type 1 diabetic patients.~   "
123094|NCT01444495|"~     The purpose of this study is to establish the influence of time-interval between~     preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall~     survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving~     procedures, radical resection rate (R0) in patients with locally advanced rectal cancer~     operated on according to TME technique. In particular 3D endosonography and 3rd generation~     ultrasonic contrast agents are evaluated to assess response to radiotherapy.~   "
123095|NCT01444482|"~     The safety of parenterally administrated investigational vaccine (commercial influenza~     vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly~     (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters~     associated with improved protection against clinical disease in elderly. Such parameters~     include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune~     response.~      Vaccination will start in 22 healthy adults receiving the investigational vaccine.~     Vaccination of elderly will be initiated only after demonstration of safety in adults. 88~     healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza~     vaccine alone and 44 will receive the investigational vaccine. Vaccines will be~     administrated intramuscularly in the upper arm. One dose will be administered to each~     volunteer included in the study. Blood samples for basic immunological assessments of~     cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150.~      The investigational vaccine is equal to one standard human dose of a commercial seasonal~     influenza vaccine to which 50 µg of adjuvant Matrix M has been added.~   "
123096|NCT01444469|"~     Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in~     asthmatic patients. Current treatments for asthma attacks are not completely effective and~     new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung~     infections have also been associated with asthma attacks. However, the role for bacteria is~     uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not~     recommend the routine use of antibiotics. The investigators would like to investigate~     whether or not azithromycin, which is a safe and well tolerated antibiotic (an~     antibacterial) that has been used for many years in the treatment of respiratory disease,~     might be of benefit in asthma attacks. As there is some evidence that azithromycin has~     anti-viral properties this may add to its benefits (antibiotics don't usually affect~     viruses). By looking at the effect of azithromycin on asthma attacks this will help us to~     show whether or not azithromycin should be recommended during an acute asthma attack in~     addition to the usual care that is provided to these patients as it may help them recover~     quicker from the exacerbation. The investigators will also be able to look at why~     azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.~   "
123097|NCT01444456|"~     This is a multicenter, international, prospective, observational study of patients who are~     receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian,~     prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are~     receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to~     treat symptomatic anaemia.~      Quality of Life will be assessed electronically with the aim of estimating improvement in~     quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an~     increase in haemoglobin (Hb) of ≥1 g/dL~   "
123098|NCT01444443|"~     The objective of this in-clinic study is to test our closed-loop glucose control system in~     patients with type 1 diabetes.~   "
123099|NCT01444430|"~     The purpose of the study is to evaluate the safety of Symbicort compared to inhaled~     corticosteroid alone during 6 months in adult and adolescent patients with asthma~   "
123100|NCT01444417|"~     The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of~     thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as~     measured by durable platelet response.~   "
123101|NCT01444404|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 820 in~     subjects with advanced solid tumors.~   "
123102|NCT01444391|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent~     Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under~     local anesthesia delivered by iontophoresis in an office/clinic setting.~   "
123103|NCT01444378|"~     To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding~     Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the~     treatment of subjects with atherosclerotic de novo or restenotic lesions in the native~     superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).~      CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL~     Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal~     (U.S.) law to investigational use only.~   "
123104|NCT01444365|"~     To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal~     Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of~     the knee.~   "
123105|NCT01444352|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of an~     investigational pneumococcal vaccine in healthy adult volunteers.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.~      Observational Objective:~        -  To evaluate the immunogenicity of an investigational Pneumococcal vaccine.~   "
123106|NCT01444339|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of two~     investigational pneumococcal vaccines at three dose levels in healthy adults.~      Primary Objective:~      - To evaluate the safety and tolerability of two investigational pneumococcal vaccines.~      Observational Objective:~      - To evaluate the immunogenicity of the investigational pneumococcal vaccines.~   "
123119|NCT01444170|"~     The objectives of this study are to assess the effectiveness of a nutritional supplement on~     muscle functional recovery following induced muscle damage from high intensity resistance~     exercise. The investigators hypothesize that a short-term dietary supplementation will~     significantly improve muscle functional recovery following an intense bout of eccentric~     exercise compared to a placebo.~   "
123377|NCT01440764|"~     The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide,~     a treatment that has the potential to significantly improve symptom management and enhance~     the quality of care for patients with intractable dyspnea.~   "
123107|NCT01444326|"~     Inflammation and endothelial dysfunction are being increasingly recognized as key~     etiological factors in the development of atherosclerosis and subsequent cardiovascular~     disease (CVD). These pro-atherogenic states are strongly correlated and often found~     co-segregating among individuals with obesity and the metabolic syndrome. There is~     increasing evidence to support the use in clinical practice of these novel markers of~     atherosclerosis and CVD risk. Recent data from the JUPITER study (Justification for the Use~     of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) has~     provided undisputable evidence that treating patients with elevated plasma CRP~     concentrations, a marker of systemic subclinical inflammation, leads to marked reduction in~     the risk of CHD even in patients with highly desirable LDL-C levels. There is also~     accumulating evidence associating endothelial dysfunction, which is defined as incapacity of~     the arteries to vasodilate when required, to an increased risk of CVD. While there are more~     and more studies on how diet affects inflammation and endothelial function, the impact of~     dairy consumption per se on these novel risk factors for CVD has not been well~     characterized.~      The purpose of this study was to investigate the impact of dairy consumption on markers of~     inflammation and other risk factors in men and women with low grade systemic inflammation.~   "
123108|NCT01444313|"~     The purpose of this study is to examine the short-term protective effect of Ultra-Violet~     filtering contact lenses on macular pigment ocular density.~   "
123109|NCT01444300|"~     Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in~     people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages~     the myelin insulation around nerves which slows conduction of messages from the brain to the~     leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.~     Recent research indicates that imbalance in MS is in large part caused by poor conduction by~     the nerves that transmit information about the position of the legs to the brain. It is~     therefore likely that, by improving nerve conduction, dalfampridine will also improve~     imbalance in people with MS. Dalfampridine will be administered in this study by the same~     route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve~     walking speed in people with MS. The proposed pilot study will examine the effects of~     dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This~     small pilot study will help to show if dalfampridine improves imbalance in MS and will guide~     the design and implementation of a larger full scale study to definitively determine if~     dalfampridine improves balance and prevents falls in people with MS.~   "
123110|NCT01444287|"~     The purpose of this research is to measure daytime open-eye response to wearing of~     narafilcon B lenses.~   "
123111|NCT01444274|"~     This will be an observational, prospective, non-randomized, pilot study to gain initial~     device experience on a novel space-occupying device in persons who are overweight or obese.~     No formal hypothesis testing will be conducted.~   "
123112|NCT01444261|"~     With early screening and appropriate iron supplementation, iron deficiency in the first year~     of life can be prevented in breastfed infants.~   "
123113|NCT01444248|"~     The study design of this trial is open-label, randomized, multi-center, parallel-group~     study.~   "
123114|NCT01444235|"~     Comparison of the cardioprotective effects and safety of two cardioplegic solutions~     (solutions used during a cardiac arrest in the heart surgery) in patients undergoing~     cardiopulmonary bypass for coronary artery bypass surgery.~   "
123115|NCT01444222|"~     Right-sided heart disease has an important impact on the prognosis of patients with valvular~     heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics~     have not been extensively investigated. However, it is plausible that a significant degree~     of TR and the associated volume-overload of the right ventricle cause significant right~     ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to~     clinical symptoms, right ventricular dilatation and ultimately right ventricular heart~     failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate~     this unfavourable evolution. Nevertheless it is likely that right ventricular failure is~     preceded with a subclinical dysfunction of the right ventricle and a possibly reversible~     change in contractility of the myocardium.~      Recently, new techniques to evaluate the systolic function, the contractility and the~     hemodynamics of the heart have become available.~      First, this study will help us assessing the feasibility and accuracy of several imaging~     modalities in right-sided heart pathology with focus on TR and right heart myocardial~     performance.~      Second, this study will contribute to a better understanding of the hemodynamic effect of~     volume-overload and/or pressure-overload of the right ventricle. It will clarify the~     behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction~     during exercise and its impact on exercise capacity. By doing this, discrimination between~     well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be~     eligible for treatment (medical, corrective, …).~   "
123116|NCT01444209|"~     This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo~     implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor~     response to treatment will be monitored as well as change in visual fields, associated~     adverse effects, progression free survival and patient reported outcomes.~   "
123117|NCT01444196|"~     The primary objective of the study is to assess the dosis of DL which is sufficient to~     inhibit cold urticaria symptoms.~   "
123118|NCT01444183|"~     The study will examine whether a stress reduction intervention reduces the number of~     seizures in people with drug resistant epilepsy. In the proposed randomized controlled,~     double blind trial, the investigators will enroll subjects with frequent seizures,~     especially those who identify stress as a seizure precipitant. There is an observational~     phase (8-12 weeks) and a treatment phase (12 weeks). During the observational phase,~     subjects will be monitored multiple times daily via smart phone devices, in order to~     identify high risk days for seizures. In the treatment phase, subjects will be randomly~     assigned to one of two groups receiving different focused attention practices. These~     behavioral interventions will be administered daily with extra interventions applied on days~     of higher risk.~   "
123378|NCT01440751|"~     The objective of this prospective randomised study is to compare the efficacy and safety of~     ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in~     uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety~     being the secondary.~   "
123120|NCT01444157|"~     When facing life threatening illness such as advanced cancer palliative care is needed to~     improve quality of life of patients and their families through the prevention and relief of~     suffering. Palliative care at an early stage prevents the development of problems and~     symptoms, but time, resources and experience are needed in the primary care sector in~     Denmark to deal with the problems families experiencing life with advanced cancer are~     facing. The aims of this study are to test, evaluate and further develop interventions that~     can help identify and assess problems, resources and opportunities of families experiencing~     life with advanced cancer, and on this background to help the families cope with their~     situation in cooperation with healthcare professionals to an extent where the family's~     quality of life increases, their physical and psychosocial problems are relieved, their~     symptoms of anxiety and depression are reduced, family satisfaction with health~     professionals are increased and acute readmissions to hospital are prevented.~   "
123121|NCT01444144|"~     The purpose of this study is to track surgical outcomes and post-operative course in~     patients 55 years of age or older treated for ankle fractures.~   "
123122|NCT01444131|"~     The purpose of this study is to test whether the addition of a nicotine patch to varenicline~     increases smoking cessation success rate and whether the combination is safe.~   "
123123|NCT01444118|"~     The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an~     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to~     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is~     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of~     proliferation of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in~     Cuba. The result from previous studies demonstrated positive correlation between extended~     survival and immune response against the vaccination in the late-stage NSCLC patients' age~     below 60 with improved quality of life. The purpose of this international Phase III trial is~     to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and~     effective in the treatment of stage IIIB/IV NSCLC patients compared to standard treatment~     and supportive care.~   "
123124|NCT01444105|"~     Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT~     procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.~   "
123125|NCT01444092|"~     A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease~   "
123126|NCT01444079|"~     Liver is an organ that is well-known for its immune tolerant capacity. However, there were~     still controversial issues about the impact of immunologic challenge after liver~     transplantation on the graft function. Different results of graft function affected by~     immunologic factors such as pre-transplant panel reactive antibody (PRA) status,~     pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor~     specific antibody (DSA) has been reported according to individual institutes. There was no~     trial for presenting anti-donor lymphocyte antibody change after liver transplantation.~      The investigators designed this study to analyze the correlation between pre- and~     post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the~     investigators will find aspects of anti-donor lymphocyte antibody change after liver~     transplantation.~   "
123127|NCT01444066|"~     The goal of our study is to determine if stretching the esophagus with a rubber dilator~     helps patients with swallowing difficulties who have a normal appearing esophagus on upper~     endoscopy. In order to do this we will perform a randomized controlled study, where patients~     will undergo esophageal dilation (stretching) with different diameter dilators. We will~     measure change in symptom severity between baseline (prior to dilation) and 1, 3, 6 and 12~     months after the procedure~   "
123128|NCT01444053|"~     The purpose of this study is to examine the long term effect of ultra-violet filtering~     contact lenses on macular pigment density (MPOD) and accommodative function.~   "
123129|NCT01444040|"~     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices~     versus medical therapy in eyes of subjects with primary open-angle glaucoma,~     pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.~   "
123130|NCT01444027|"~     In recent years, the demand for home hospice care has grown rapidly. Family members and~     friends who act as informal caregivers are essential to the provision of palliative care~     services; however, this role is not without adverse effects on the caregivers themselves. It~     is well documented that emotional needs of individuals caring for dying persons in their~     home are not well attended, and interventions aiming to provide support to informal hospice~     caregivers are notably lacking. In this context, problem solving therapy (PST) provides an~     overall coping process that fosters adaptive situational coping and behavioral competence.~     The investigators are conducting a randomized controlled trial to fully evaluate the PST~     intervention for informal hospice caregivers. Additionally, the investigators aim to~     evaluate how the modality of the intervention (face to face vs video) impacts its~     effectiveness. This investigator team is conducting a 4-year randomized trial study in which~     hospice caregivers will be randomly assigned to a group receiving standard hospice care with~     the addition of social support interactions (attention control group) or a group receiving~     standard hospice care with the addition of the problem solving intervention delivered face~     to face (intervention group 1) or a group receiving standard hospice care with the addition~     of the problem solving intervention delivered via video (intervention group 2). The specific~     aims include an assessment of the impact of PST on caregiver quality of life, problem~     solving ability, and caregiver anxiety.~   "
123150|NCT01443767|"~     The purpose of this study is to determine the measuring accuracy of the truly non-invasive~     method estimated continuous cardiac output (esCCO) against the reference method pulse~     contour analysis of the arterial waveform (Picco) in partial liver resection. esCCO is~     calculated using the pulse wave transit time, which is defined as the time between the~     R-wave of the ECG and a 30% increase of the differentiated pulseoximetry waveform.~   "
123270|NCT01442168|"~     The purpose of this study is to determine the tolerability and pharmacokinetics of~     Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil®~     (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated~     malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected~     erythrocyte sequestration and rosette formation.~      The study consists of a dose escalation part (part 1) followed by an open labelled,~     randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone~     (part 2).~   "
123131|NCT01444014|"~     The aim of the study is to find out if the experimental medicine, YF476, can make gastric~     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur~     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the~     acid-producing cells in the lining of the stomach can't make acid. Acid production is~     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.~     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin~     in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow~     and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually~     benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids~     have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric~     carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of~     which is a mini video camera, which enables the user to inspect the lining of the stomach~     and a 'snare' to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor~     antagonist (blocks the effects of gastrin), so it's a potential new medical treatment for~     gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily~     for up to 12 weeks. They'll make up to seven outpatient visits for tests, including checks~     on the safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric~     carcinoids will be measured and biopsies taken for laboratory tests. Patients will take up~     to 24 weeks to finish the study.~   "
123132|NCT01444001|"~     This study was designed to evaluate the safety, tolerability, and immunogenicity of three~     doses of an investigational pneumococcal vaccine in healthy adult volunteers.~      Primary Objective:~        -  To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.~   "
123133|NCT01443988|"~     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus~     medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative~     glaucoma, or ocular hypertension naïve to medical and surgical therapy.~   "
123134|NCT01443975|"~     The purpose of this study is to clinically evaluate the use of the x-pander device.~   "
123135|NCT01443962|"~     During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional~     oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the~     respiratory parameters include oxygenation. So applying PEEP could improve the regional~     brain oxygen saturation (rSO2)~   "
123136|NCT01443949|"~     Background:~      - The risk for becoming addicted to drugs varies from person to person, even among those who~     use similar drugs in a similar way. Studies suggest that certain personality traits seen in~     people with drug addiction may be present before drug use. These traits include responding~     differently to rewards or impulsivity. Early use of drugs (before age 15) is also associated~     strongly with drug addiction later in life. Researchers want to study teenagers with and~     without certain behavioral problems, including those who have used drugs and those who have~     not. This may help them better understand behaviors that might predict future drug~     addiction.~      Objectives:~      - To understand brain function in teenagers who may be at a higher risk than others to drug~     addiction.~      Eligibility:~        -  Teenagers between 13 and 17 years of age who fit into one of four groups:~        -  Have never or rarely used drugs~        -  Have never or rarely used drugs and have conduct or behavior disorders~        -  Have used drugs on many occasions~        -  Have used drugs on many occasions and have conduct or behavior disorders~      Design:~        -  Participants will be screened with a medical history, and physical and neurological~          exams. They will also have blood and urine tests. Participants will answer questions~          about past drug use and any current medications. They will also have a breathalyzer and~          carbon monoxide breath test to check for recent drug and alcohol use.~        -  This study requires four visits to the clinical center for magnetic resonance imaging~          (MRI) scans and other tests.~        -  The first study visit will include training for the MRI scans. Participants will~          practice the tasks in front of a computer and in a mock (fake) MRI machine.~          Participants will also be asked several questions about their personality and past~          experiences.~        -  Researchers will test changes to tryptophan and dopamine levels. Both of these~          chemicals affect decision making and brain function. On the three study visits,~          participants will have the following tests in a randomly selected order. One study will~          be done at each visit.~        -  MRI scans with changes to dopamine and tryptophan levels~        -  MRI scans with changes to dopamine only (with placebo)~        -  MRI scans with changes to tryptophan only (with placebo)~        -  Participants will be monitored with frequent blood draws and other tests during the~          study visits.~   "
123137|NCT01443936|"~     This is a Phase 1 randomized, single center, dose-escalation study designed to evaluate the~     safety and immunogenicity of live, replication competent recombinant Adenovirus type~     4-H5N1Influenza Vietnam 1194 Hemagglutinin (HA) (Ad4-H5-Vtn). Determining the optimal route~     and dose for this recombinant platform will greatly accelerate investigations of this vector~     as an influenza vaccine and an HIV vaccine platform.~      Intranasal and tonsillar administration of the vaccine will be separately assessed. The oral~     enteric-coated capsule will also be assessed in 10 outpatients using similar blood sampling~     for comparison. The Ad4-H5-Vtn orally administered as enteric-coated capsules has already~     been evaluated in an ascending dose Phase 1 study, in dosages as high as 10(11) viral~     particles (vp).~      The primary goal of this study is to evaluate safety of ascending dosages of the Ad4-H5-Vtn~     vaccine following intranasal and tonsillar administration. A dosage or dosages will be~     selected to further evaluate the humoral, cellular, and mucosal immune responses against~     both the vector and the inserted gene. The Ad4-H5-Vtn will be initiated at 10(3) vp. Once~     safety is established at the initial dose, a second round of testing will begin at the next~     ten-fold higher dose. The Ad4-H5-Vtn vaccine will be assessed in three participants at each~     dosage level. The maximum viral dose administered by the tonsillar route will be 10(8) vp.~      In addition to clinical and laboratory monitoring of safety, the principal assessments will~     be shedding of the Ad4-H5-Vtn virus in rectal, cervicovaginal, throat, and nasal swabs, and~     assessment of the antibody (mucosal and systemic) response to the HA and to the Ad4 virus.~     When safety has been confirmed in all three participants at a given dosage level, the next~     higher dose group is enrolled. If one grade 3 or greater toxicity (or pre-specified Grade 2~     toxicity, see Section 3.4) attributable to the vaccine is observed, the group will be~     expanded at that dose. If a second attributable grade 3 or greater toxicity (or~     pre-specified Grade 2 toxicity, see Section 3.4) is observed, the dose will be reduced one~     level and the group will be expanded. Up to 25 Ad4-seronegative individuals will be enrolled~     at the maximum tolerated dose to fully evaluate safety and immunogenicity in the protocol.~      All participants will be followed for 28 days following immunization, and again at 8 and 26~     weeks to evaluate any long-term toxicity and persistence of immunity. Tonsillar Participants~     will receive a booster dose of vaccine [SK1]at the 26-week visit and be seen for follow-up~     visits at Weeks 30 and 34. Household and intimate contacts will also be enrolled and~     monitored for Adenovirus and HAI antibodies.~   "
123138|NCT01443923|"~     Background:~      - Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN~     and ribavirin. However, this treatment is not very effective in people with a serious type~     of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV)~     coinfection. Researchers want to add a new drug, boceprevir to see if it can improve~     treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination~     with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV~     genotype 1 infection only, and is currently being studied in those with HIV and HCV.~      Objectives:~      - To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people~     with HCV monoinfection compared to those with both HIV and HCV infections.~      Eligibility:~        -  Individuals at least 18 years of age who have HCV genotype 1 infection, and have not~          received interferon treatment for HCV~        -  Half of the study participants will also have HIV infection.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests.~        -  Participants will also have heart and liver function tests, and answer questions about~          mood and depression.~        -  Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to~          inject under the skin weekly.~        -  Two weeks after starting treatment, participants will have blood tests to study the~          treatment.~        -  Four weeks after starting treatment, participants will start taking boceprevir three~          times a day.~        -  Participants will have regular study visits with blood samples and other tests. The~          length of therapy will depend on the level of virus detected in the blood at several~          clinic visits. Those who do not respond well to the medicines at 12 weeks will stop~          treatment. The full length of treatment is 48 weeks.~   "
123163|NCT01443598|"~     HYPID study is an observational and prospective study of patients with interstitial lung~     disease and pre capillary hypertension diagnosed by right heart sided catheterization. The~     primary aim of the study is to identify prognostic factors.~   "
123139|NCT01443910|"~     This study is part of an effort to learn about interactions between doctors and patients. We~     aim to understand how women feel about techniques that doctors use to talk with patients~     about their weight. We are studying women s reactions to these techniques using a virtual~     reality version of a doctor s office to create as realistic a model of a doctor s visit as~     possible. This can help us better understand what happens during real doctor s visits.~      Women between the ages of 20 and 50 who are currently overweight may be eligible for this~     study. Participants will be recruited from the Washington D.C. area. This is not a weight~     treatment study.~      Participants undergo the following procedures:~        -  Complete an online questionnaire about themselves, their experiences, and their~          thoughts about their weight~        -  Participate in activities in a virtual reality environment in which they interact with~          a virtual doctor in a virtual clinical scenario. For this experiment, participants wear~          a head-mounted display that allows them to see the virtual world images.~        -  Fill out a questionnaire after completing the virtual reality activities. This~          questionnaire includes information on the participants' virtual reality experience, the~          information provided in the experience, and additional questions about themselves and~          their thoughts.~   "
123140|NCT01443897|"~     This study will investigate whether mushrooms treated with ultraviolet (UV) light to~     increase their vitamin D2 content are actually a good source of vitamin D when consumed~     daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which~     will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting~     improvement in vitamin D status affects the immune system by decreasing it's level of~     activation, which may be abnormally elevated in vitamin D deficiency.~   "
123141|NCT01443884|"~     The goal of the study is to determine whether grape consumption can reduce the risk of~     cardiovascular disease by reducing the presence of inflammatory molecules and positively~     altering cholesterol levels, lipid profiles, and immune cell responses.~   "
123142|NCT01443871|"~     The purpose of this study is to examine and compare electroencephalography (EEG) changes in~     human subjects directly after inhalation of essential oils from five Thai aromatherapies.~     The investigators hypothesize that essential oils from Thai aromatherapies may influence the~     human EEG involving emotional relaxation particularly alpha wave EEG.~   "
123143|NCT01443858|"~     The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent~     or treat motion sickness, can help smokers quit smoking. This study will also investigate~     the potential relationship between genes you have inherited and success in quitting smoking.~   "
123144|NCT01443845|"~     To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination~     (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe~     COPD.~   "
123145|NCT01443832|"~     The study sought to investigate the effect of lowering phytic acid in fonio porridge with~     phytase activity naturally occurring in wheat flour on iron absorption using labelled stable~     isotopes of iron. The study population is represented by 16 apparently healthy young~     Beninese women aged 18-30 years recruited based on their willingness to participate and~     according to inclusion criteria. Test meals consisted of fonio porridges fortified with~     isotopically labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals~     were administered to fasting subjects on two consecutive days using a randomised crossover~     design: half the subjects received the test meal on the first day and the control on the~     second day and vice versa. Venous blood sample were collected (day 1 and day 14) for iron~     status and iron absorption measurement. Iron absorption measurement is based on erythrocyte~     incorporation of iron stable isotope labels 14 days after intake of the labelled test meals~     and calculated based on isotope-dilution.~   "
123146|NCT01443819|"~     The purpose of this research study is to look at two of the common forms of treatment for~     this condition: physical therapy and epidural steroid injection. The investigators are~     attempting to evaluate whether or not physical therapy alone, or epidural steroid injections~     alone, are effective in treating this condition. The investigators will also try to~     determine whether or not one of these treatments is better than the other for the treatment~     of herniated discs with nerve injury (radiculopathy).~   "
123147|NCT01443806|"~     The aim of this study is to evaluate the conversion of OP to OC in individual X and the~     family member of individual X. The investigators hypothesize that one or more of the single~     nucleoprotein polymorphisms (SNPs) of the CES1 gene represent a clinically important~     functional polymorphism.~   "
123148|NCT01443793|"~     The objective of this active surveillance study is to make available crucial data about~     epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility~     of nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy~     children aged less than years and living in the area of Milan and surroundings, Lombardy,~     Italy.~        -  To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus~          pneumoniae in healthy children aged less than 5 years living in the area of Milan,~          Italy;~        -  To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae~          strains in healthy children aged less than 5 years~      Secondary objectives:~        -  To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae~          strains in healthy subjects less than 5 years old;~        -  To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in~          healthy children;~        -  • To evaluate the possible impact of vaccination policy in the referenced population.~   "
123149|NCT01443780|"~     The dietary supplements selenium and Q10 has been evaluated in a double blind~     placebo-controlled study in an elderly Swedish population. The hypothesis is that as a~     majority of Northern Europeans suffers insufficient levels of selenium that is used by the~     cell in the building of at least 25 different enzyme systems in the body, and that the cell~     need presence of Q10 in order to produce the selenium containing enzymes, we wanted to~     evaluate the effect of a combined intervention of the two supplements in an elderly~     population in Sweden. All participants were controlled every 6 months, and the intervention~     was 48 months in each participant. Besides blood samples, echocardiography and cardiac~     natriuretic peptides were analyzed at start, every 6 months and at end of the study.~   "
123164|NCT01443585|"~     The purpose of the trial is to clinically evaluate the performance of a progressive addition~     lens among presbyopic patients.~      This evaluation will be done by performing visual tests and collecting subjective~     information from subjects wearing the lens which will be manufactured according to personal~     prescription.~   "
123151|NCT01443754|"~     The present study is designed as a prospective, single centre, open label, observational~     trial.~      The study will collect information about the medical care patients receive during their~     planned procedure(s). No new testing or procedures will be done.~      Patients elected for hybrid revascularization will be asked their written consent to the use~     of their personal data.~      Left internal mammary artery to the Left Anterior Descending Coronary Artery~     (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous~     revascularization of the other vessels in the frame of the same hospitalization.~      After discharge patients will attend clinic visits at 30 days and 12 months, as per usual~     clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic~     follow-up will be performed in symptomatic patients, as clinically indicated.~   "
123152|NCT01443741|"~     Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic~     control, hypoglycemia prevention and life quality of diabetics children insulin-dependent~     treated with insulin pump.~   "
123153|NCT01443728|"~     This study aims to answer the question whether oral vitamin D supplementation can decrease~     lung complications in children and adolescents with sickle cell disease. Lung complications~     are the leading causes of morbidity and of death in sickle cell disease. Infections and~     increased inflammation play important roles in the development of the lung problems in~     sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight~     infection and to control inflammation and could potentially help prevent respiratory~     complications in patients with sickle cell disease. The investigators hypothesize that oral~     vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents~     with sickle cell disease, will reduce the rate of respiratory events (infection, asthma~     exacerbation and acute chest syndrome) compared to the rate in a group given standard dose~     oral vitamin D3, 12,000 IU (0.3 mg) given once a month.~      Funding Source - U.S. Food & Drug Administration, Office of Orphan Products Development~   "
123154|NCT01443715|"~     It is challenging for depressed adolescents and their families to access specialized mental~     health services. A viable option is delivering treatment in the primary care clinic (PCC)~     setting; however, few effective models are currently available. The overall aim of this~     study is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a~     novel collaborative stepped care model of treatment for depressed adolescents.~   "
123155|NCT01443702|"~     The investigators will investigate the safety and effectiveness of an Iranian traditional~     medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers~     will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo~     in random order. End points are changes in urinary chemistries and stone burden by Ultra~     sonography / CT scan.~      It will be used in proven calcium stone forming adults who are not pregnant. This phase is a~     double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine~     supersaturations, pH and sodium determinations will be collected. Entry and final stone~     quantification Ultra sonography / CT scan will be performed. End points will be changes in~     urine chemistry/supersaturation and stone quantitative stone volume.~   "
123156|NCT01443689|"~     Burn trauma,especially extensive ones, remains a life-threatening local and general~     inflammatory condition destroying the skin and underlying tissues, and resulting in serious~     sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays~     an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs)~     and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to~     modulate the immune response and enhance angiogenesis, suggesting the novel and promising~     therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs~     transplantation will be evaluated in patients with acute burn.~   "
123157|NCT01443676|"~     The purpose of this study is to explore the efficacy of bevacizumab combined with~     radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed~     glioblastoma in the elderly.~        -  Trial with medicinal product~   "
123158|NCT01443663|"~     H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study~     will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have~     previously received one of two versions of an H5N1 vaccine or have previously received an~     H7N3 vaccine and in people who have not previously received any live attenuated influenza~     vaccine (LAIV).~   "
123159|NCT01443650|"~     Primary Objective:~      Injection Site Tolerability~      Secondary Objectives:~        -  To assess the safety profile of alirocumab SAR236553 (REGN727)~        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553~          (REGN727)~   "
123160|NCT01443637|"~     The CONFIRM study was developed to examine the prognostic value of cardiac computed~     tomographic angiography (CCTA) findings for prediction of future adverse cardiac events~     related to coronary artery disease (CAD) in a large, international patient population. The~     purpose of this multicenter registry is to correlate coronary and non-coronary cardiac~     findings by CCTA with demographic and clinical data for refinement of risk stratification of~     individuals with suspected or known CAD.~   "
123161|NCT01443624|"~     The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in~     critically ill patients and in healthy volunteers. The investigators hypothesize that the~     inflammatory state of critically ill patients will reduce the oxydative stress induced by~     iron injections, compared to the one induced in healthy volunteers. It will be an open~     proof-of-concept study aimed at evaluating iron toxicity in critically ill patients (n=40)~     as compared to healthy volunteers (n=40).~      The investigators will compare the oxidative stress (principal judgment criteria=~     8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post~     injection) in both groups and the investigators will compare the effect of repeated~     injections in the critically ill patients.~   "
123162|NCT01443611|"~     The actual recommendations for infants aged 3 to 12 months presented with first episode of~     Febrile Convulsions highly recommend performing lumbar puncture in order to rule out~     Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal~     vaccination arise the question if in the presence of a normal physical examination those~     recommendations are still relevant. The purpose of this study is to summarized~     retrospectively the clinical records of all the infants admitted to the pediatric wards in~     the ten years period since 2000 to 2010 in order to record the incidence of Bacterial~     Meningitis among infants admitted with the First episode of Febrile Convulsions.~   "
123165|NCT01443572|"~     Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by~     inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to~     cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in~     BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of~     inhalation anesthetic that minimally affects hepatic function is important. Therefore, the~     purpose of this study is to compare the postoperative recovery and hepatic function between~     desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients~     undergoing Kasai operation.~   "
123166|NCT01443559|"~     Acellular porcine cornea is a valid substitution for human cornea because of its similar~     biological structure, corneal superficial curvature and good histocompatibility toward~     human. Facing the lack of human cornea donor, it is hypothesised that using acellular~     lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious~     corneal ulcer.~   "
123167|NCT01443546|"~     The project is a randomized, controlled, prospective study of oocyte donors comparing the~     safety and efficacy of triggering ovulation using a combination of two drugs—GnRH agonist~     and very low dose hCG—versus triggering ovulation with a standard hCG dose alone or a~     standard GnRH trigger alone.~   "
123168|NCT01443533|"~     This study is a randomized controlled trial that will evaluate the impact of a brief~     educational script on the method of birth control that women receive at their 6-week~     postpartum visit. The one-minute script (LARC script) is given to women in the hospital~     during their postpartum admission. It informs patients about long-acting reversible~     contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine~     device. The investigators hypothesize that women who are randomized to receive the LARC~     script will be more likely to report that they are using a LARC method, when queried~     immediately after their six-week postpartum visit.~   "
123169|NCT01443520|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral~     tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve~     healthy male or female adult non-smoking volunteers aged 18-40 years with body weights~     within ±15% of the ideal weight for height are taken into the study. Primary endpoints of~     the study are plasma concentrations of tramadol and its metabolites.~   "
123170|NCT01443507|"~     The purpose of the study is to compare exercise at 70% of maximal heart rate were total~     energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate.~     Since 70% of maximal heart rate is well above the minimum threshold for improvements in~     maximal oxygen uptake it should be suited to investigate the effect of duration.~   "
123171|NCT01443494|"~     We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved~     sublingual microcirculation.~   "
123172|NCT01443481|"~     This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at~     single-dose and steady state in adult cancer patients either with mild, moderate or severe~     hepatic impairment or with normal hepatic function. Hepatic function in study patients will~     be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total~     bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and~     ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by~     RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for~     any other reason.~   "
123173|NCT01443468|"~     Background:~      - Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types~     of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It~     may also increase the risk for certain types of leukemia and other cancers. The only known~     cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all~     people with LFS have a TP53 mutation. Researchers want to study other possible genetic~     causes of LFS, and factors that may increase or decrease cancer risk in people with the~     syndrome.~      Objectives:~        -  To learn more about the types of cancers that occur in individuals with LFS.~        -  To study the role of the TP53 gene in the development of cancer.~        -  To look for other possible genes that cause LFS~        -  To study the effect of LFS diagnosis on families.~        -  To determine if environmental factors or other genes can change a person s cancer risk~          associated with LFS.~      Eligibility:~        -  Individuals with a family or personal medical history of cancers consistent with LFS.~        -  Individuals with a family or personal medical history of cancers that does not meet the~          diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the~          so-called Li-Fraumeni like syndrome)~        -  Individuals with certain rare cancers~        -  Individuals with a family or personal history of a TP53 gene mutation, with or without~          related cancer(s).~      Design:~        -  Participants will fill out a medical history questionnaire and a family history~          questionnaire.~        -  Blood samples will be collected for DNA and for storage. Cheek cell samples may be~          collected if blood cannot be obtained for DNA. Participants can choose to have or not~          have cancer screening with blood tests, imaging studies, and other exams.~        -  Participants will complete questionnaires about their worries about cancer, stress~          levels, and coping strategies. Diet and physical activity questionnaires will also be~          given. Other psychological tests may be given as needed.~        -  Participants will be monitored for several years, with regular followup visits to the~          National Institutes of Health, if indicated. Any changes in health or cancer status~          will be recorded.~   "
123174|NCT01443455|"~     This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed~     entry controls. The interventions have two phases; a 12 week initiation phase with~     substantial structure and supervision, followed by a 12 week transition phase, with reduced~     structure and supervision. Participants are 168 overweight or obese, sedentary~     postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control~     group.~      The following research questions will be assessed:~        1. Is exercise adherence at 6 months better with video dance games compared to brisk~          walking?~        2. Does video dance game exercise compared to wait list controls, induce beneficial~          changes in physical and mental health?~        3. Does video dance game exercise compared to brisk walking better promote balance,~          attention and visual spatial skills, without loss of benefit to cardiovascular fitness?~        4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If~          so, who and why?~   "
123188|NCT01443247|"~     The purpose of this study is evaluate the role of anti-d in dengue fever.~   "
123189|NCT01443234|"~     This research study is designed to investigate the effects of an online computer program,~     called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The~     OxIGen program will be delivered online over four weeks and with follow-up at one, three and~     six months. This will inform potential future development of this computerized task into an~     online intervention to modify negative thinking styles in depression.~   "
123190|NCT01443221|"~     To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose~     combination of mitiglinide/metformin, compared with free combination of mitiglinide and~     metformin in healthy male subjects.~   "
123175|NCT01443442|"~     Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically,~     patients manifest symptoms in the spring, summer and fall, when airborne allergens are at~     their peak. Patients may also be afflicted year-round, if sensitive to allergens such as~     dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival~     hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and~     burning.~      This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine~     besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the~     treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years.~     The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms~     (itching) will be monitored as outcome variables.~   "
123176|NCT01443429|"~     The PK and safety profiles to be examined following a single oral administration of~     TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to~     subjects with normal renal function.~   "
123177|NCT01443416|"~     This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination~     (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called~     Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein~     called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence~     that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used~     vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains~     only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two~     of the three additional serotypes included in PCV-13 which might be enough to protect~     children against disease caused by these two serotypes. Furthermore, previous studies have~     shown that PHiD-CV confers protection against a common otitis media pathogen in children~     called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D,~     which is derived from NTHi. In addition, the use of a carrier protein, which is not closely~     related to an antigen included in any coadministered or previously administered routine~     vaccine minimises the risk of interference related to it.~      The investigators aim to recruit 168 healthy children at the age of 12 months who have~     already received two doses of PCV-13 according to the UK routine immunisation schedule at 2~     and 4 months of age. Participants will then be randomised to receive a booster dose of~     either PCV-13 or PHiD-CV at 12 months of age.~      Three visits will take place at their parents' home and will involve a blood test followed~     by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month~     after visit 1) and 3 (1 year after visit 1).~   "
123178|NCT01443403|"~     The purpose of this study is to determine efficacy and safety of S-297995 for the treatment~     of opioid-induced constipation in subjects with non-malignant chronic pain receiving opioid~     therapy for ≥3 months~   "
123179|NCT01443390|"~     When a patient with advanced cancer consults with a member of the Phase I drug development~     team, the investigators utilize all information possible to try to select a therapy for that~     patient which has the best chance of working for them. This information includes:~        1. Past published information~        2. Clinical experience and judgement~        3. Immunohistochemistry for specific targets (e.g., ER)~        4. Standard sequencing (e.g., for K-Ras) and other methods now available.~      The investigators have a new tool which warrants early exploration for what role it might~     eventually play in the process of selecting the best therapy for an individual patient. The~     basis of the current ancillary exploratory study is to gain initial experience with the~     operational aspects of this whole genome sequencing in this setting.~   "
123180|NCT01443377|"~     This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in~     patients with locally advanced KRAS wild-type rectal cancer.~   "
123181|NCT01443364|"~     The study aims to evaluate the predictability of early response to Certolizumab pegol in~     combination with Methotrexate at one year in patients with moderate to severe rheumatoid~     arthritis.~   "
123182|NCT01443351|"~     Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with~     refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for~     long-term effects of these drugs. In this observational study, effects and adverse effects~     including evaluation of bone marrow biopsies done at fixed intervals will be recorded from~     ITP patients treated with TPO-ra. For some patients, blood samples will be collected for~     research use.~   "
123183|NCT01443338|"~     The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are~     effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.~   "
123184|NCT01443325|"~     In the present placebo-controlled cross-over study the researchers intend to investigate~     analgesic and sensory effects of a lidocaine patch in patients with severe persistent~     inguinal post-herniorrhaphy pain.~   "
123185|NCT01443312|"~     The definition of Thalassemia Intermedia is not generally accepted and the specific clinical~     and laboratory characteristics varies between patients. Some patients are blood transfusion~     dependent and others are occasionally transfused. Also the mutations in the beta globin gene~     are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1~     gene can affect the clinical course of this disease. The purpose of this study is to~     summarize the characteristics of patients with Thalassemia Intermedia treated at the~     Pediatric Hematology Unit at the HaEmek Medical Center in Israel~   "
123186|NCT01443273|"~     There are several factor that can be related to Neonatal Thrombotic events. Among them~     hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin~     mutation are the most common causes of hereditary thrombophilia. The incidence of in the~     arab population is known to be higher than the incidence in another western populations. The~     purpose of this study is to review retrospectively the thrombophilic risk factors that were~     found in a cohort of premature babies and term newborns treated and investigated at the~     Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.~   "
123187|NCT01443260|"~     The purpose of this study is to determine whether GL-ONC1, an attenuated vaccinia virus, is~     safe when administered to patients with peritoneal carcinomatosis via an infusion within the~     abdominal cavity through an implanted catheter. The study seeks also to arrive at a~     recommended dose and schedule for future investigations, evidence of anti-tumor activity,~     detection of virus in body fluids, analysis of viral delivery to tumor and normal cells, and~     to evaluate if there is an antibody response to vaccinia virus.~   "
123192|NCT01443195|"~     Iron is an essential micronutrient that plays an important role in cellular functions of all~     microorganisms. Both iron deficiency and iron excess during the early weeks of life can have~     severe effects on neurodevelopment that may persist into adulthood and may not be corrected~     by restoration of normal iron levels.~      Iron overload remains a significant concern in preterm infants because they have low levels~     of iron-binding proteins and immature antioxidant systems.~      The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW~     Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the~     iron supplementation practice for VLBW preterm infants as implemented in the Neonatal~     Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.~   "
123193|NCT01443182|"~     Eye movement desensitization and reprocessing (EMDR) and trauma-focused~     cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating~     post-traumatic stress disorder (PTSD) following single-event traumas and to be more~     effective than pure anxiety management or stabilization treatments. However, much less is~     known about the efficacy of the different treatment approaches in survivors of repeated or~     chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization~     treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in~     survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim~     of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2)~     stabilization + EMDR using a randomized controlled trial in a routine clinical setting.~   "
123194|NCT01443169|"~     This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence~     cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a~     330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro~     dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg~     market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th~     period to to estimate and compare the % of dose absorbed versus time profile for the three~     CR prototype tablets and the CR reference tablet.~   "
123195|NCT01443156|"~     BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and~     can lead to many harmful health outcomes such as a higher risk of obesity, heart disease,~     and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's~     awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high~     interest among those who have irregular and/or extended work schedules, because such~     schedules can interfere with normal biological rhythms of sleepiness and wakefulness.~      PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep~     patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital~     staff). The investigators hypothesize that the nontraditional, irregular, and extended work~     hours common in these professions will have adverse health and cognitive effects. The~     purposes of this protocol are to:~        -  Enroll caregivers into a one year cohort study on the relationships among work~          schedule, sleep, diet, chronic disease, and cognitive performance. (A cohort study~          follows a group of participants over time to see how different behaviors or risk~          factors affect health.)~        -  Collect data from caregivers on work schedule, sleep, diet, chronic disease, and~          cognitive performance.~        -  Give personalized information and feedback to caregivers about these health factors.~        -  Educate caregivers about healthy diet and exercise choices.~        -  Collect saliva from caregivers for future research on the role of genes in health.~          (Specimen collection for genetic testing will be offered as a separate option for study~          participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research~          and education program (OHSU IRB #3694) as a platform for recruitment and data~          collection. Caregivers will be invited to participate in a Let's Get Healthy! event and~          will be given information prior to the event about the cohort study. At the Let's Get~          Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB~          #3694), in which demographic and health screening data are linked to a random number.~          Caregivers will then have the option to consent to a cohort study, in which data are no~          longer anonymous but instead linked to participants' names and contact information.~      PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get~     Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants~     provide anonymous data at health fairs through any or all of the following manners: short~     computer surveys on cancer awareness, risk factors, and family history (with immediate~     feedback given on cancer risk and prevention); short computer surveys on diet and sleep~     patterns (with immediate printed feedback given); health screening measurements (blood~     pressure, height, weight, waist circumference, body mass index, body fat percentage); a~     finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a~     saliva specimen.~      However, this cohort study (OHSU IRB #7542) will make the following changes and additions:~        -  Personal health data, instead of being anonymous, will be linked to participants' names~          and contact information (for follow-up data collection).~        -  Let's Get Healthy! events will include cognitive performance tests, a preventative-care~          survey, and a work schedule survey.~        -  Participants will provide data not only at an initial Let's Get Healthy! event, but~          also at a follow-up event and during the time period between events. Between events,~          participants will do the surveys on work schedule, diet, and sleep, and they will~          complete cognitive performance tests.~        -  There will be a separate consent process for participants to provide a fully~          identifiable saliva specimen.~      DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data~     collection but will be coded and stored in a physically separate location from the~     identifiable information. The link between identifiable information and coded health~     information will be stored on a password protected computer, and all identifiable~     information will be deleted upon completion of data analyses. Data will be analyzed to~     explore relationships among work schedule, sleep, diet, body composition, metabolic health,~     chronic disease, and cognitive performance in caregivers. Genetic relationships with these~     factors will be analyzed in those who provided a saliva specimen during entry visit data~     collection.~   "
123196|NCT01443143|"~     This investigation will examine the effects of consuming a structured, portion-controlled,~     low-glycemic index diet (commercially available as the Nutrisystem-D program) on several~     indicators of glycemic stability and variability among participants with type 2 diabetes.~     Results on the portion-controlled diet will be compared with those on participants' usual~     diets in a randomized cross-over trial. The investigators expect that participants will~     exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic~     variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the~     Nutrisystem D program, as compared with their usual diet.~   "
123197|NCT01443130|"~     The purpose of this study is to test prevention strategies for pregnancy-related malaria.~     Researchers will compare different malaria treatments and treatment schedules which include~     chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each~     time) to the standard practice of preventive treatment intervals in pregnancy (with the drug~     sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900~     pregnant women, who will be assigned to one of three treatment groups. Blood samples will be~     collected at every visit before birth and any time the participant is ill to determine if~     malaria is present. Pregnant women will be monitored during pregnancy and newborns will be~     assessed at birth and followed until about 14 weeks. Participant involvement in the study is~     expected to last about 12 months.~   "
123198|NCT01443117|"~     HIV-infected people and pregnant women are at risk of developing severe pneumococcal~     disease. The purpose of this study is to compare the safety and immune response to two~     pneumococcal vaccines in HIV-infected pregnant women.~   "
123199|NCT01443104|"~     Coronary artery stents have improved the safety and efficacy of percutaneous coronary~     intervention for coronary artery disease. Drug-eluting stents have been shown to decrease~     neointimal hyperplasia and to reduce the rate of restenosis and target-lesion~     revascularization as compared to bare-metal stents. Drug-eluting stents consist of a~     metallic platform and a therapeutic substance that is usually released from a polymer~     matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable~     safety and efficacy profile in a large-scale clinical trial as compared to a~     first-generation druf-eluting stent (LEADERS trial).~      The objective of the study is to compare the safety and efficacy of a sirolimus-eluting~     stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer~     in a prospective multicenter randomized controlled non-inferiority trial in patients~     undergoing percutaneous coronary intervention in routine clinical practice.~   "
123200|NCT01443091|"~     Colostrum, mothers' early breastmilk, contains multiple factors that provide immune~     protection to very low birth weight (VLBW) infants, a population at high risk for~     hospital-acquired infections. However, critical illness during the first few days of life~     often prevents the initiation of enteral feeds, placing these infants at even higher risk~     for morbidities including feeding intolerance and infection. Oropharyngeal administration~     has been proposed as an alternative route of delivery for colostrum and the immune benefits~     it provides. Research from animal and adult human models supports oropharyngeal~     administration as a potentially safe and effective mode of delivery for immune therapies.~     Immune components of colostrum, such as secretory IgA, may have both direct and indirect~     effects on the immune system. The purpose of this proposed randomized, placebo-controlled~     pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on~     immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition~     to measuring sIgA response to OAC the investigators will also collect clinical data to~     determine if OAC has effects on tolerance of enteral feedings and rates of infection. The~     investigators hypothesize OAC will have a moderate effect on salivary secretory IgA~     concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants~     could have far reaching consequences for these highly fragile babies including lower rates~     of infection, improved tolerance of enteral feedings, and shorter NICU stays.~   "
123271|NCT01442155|"~     This observational study evaluates the efficacy and safety of capecitabine in combination~     with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data~     were collected from each participant for up to 36 months or until disease recurrence.~   "
123201|NCT01443078|"~     The purpose of this study is to test a new approach to the use of standard drugs before~     surgery in patients with lung cancer. This study will find out what effects, good and/or~     bad, that this approach has on the cancer.~      It is routine to give chemotherapy prior to surgery in patients with this type of lung~     cancer, to help keep it from coming back. It is also routine to perform a special type of~     scan called a PET scan. This PET scan measures how active a cancer is by use of a special~     tracer made out of sugar. In this study, all patients will have a PET scan and then be~     treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a~     non-squamous cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In~     rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most~     patients, a repeat PET scan will show that the tumor is decreasing and they will complete~     standard chemotherapy then go on to have surgery.~      In some patients, a repeat PET scan will show that the tumor has not decreased enough. For~     these patients, the routine practice is to proceed with surgery. This research study will~     test whether switching from the standard treatment of pemetrexed and cisplatin or~     gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe~     and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in~     a different way than pemetrexed or gemcitabine and cisplatin.~   "
123202|NCT01443065|"~     This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France.~     Main eligibility criteria include: histologically proven adenocarcinoma of the stomach,~     esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable~     disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.~   "
123203|NCT01443052|"~     A large proportion of falls in older people occurs when walking. Most studies have recently~     demonstrated correlation between the variations in spatiotemporal gait parameters and fall~     risk in elderly and in several diseases. The investigators objective is to analyse this~     parameters in population with gait stability disorders (post-stroke patients and fallers) to~     identify the most valuable and to develop/test a conglomerate stability score.~   "
123204|NCT01443039|"~     The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric~     Bypass.~      Primary aim : To study the intra individual evolution of phenotypical markers of different~     drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and~     P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.~   "
123205|NCT01443026|"~     The purpose of this research study is to compare the effects of a lycopene supplement made~     from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal~     cells in the prostate, but have not yet had cancer detected. This study will allow us to see~     if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and~     in chemicals measured in the blood that go along with a higher risk of developing cancer.~   "
123206|NCT01443013|"~     This observational study is designed to analyse the urinary mRNA expression of Foxp3 and~     Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal~     transplant recipients from 17 renal transplant site in France and to determine the~     predictive value of these gene expression on the one year graft outcome including graft~     function, one-year graft histological analysis and incidence of acute rejection.~   "
123207|NCT01443000|"~     The purpose of this study is to characterise the clinical features, histopathology and the~     treatment outcomes of patients with idiopathic orbital inflammation syndrome.~   "
123208|NCT01442987|"~     The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan~     and Atorvastatin in patients with hypertension and hyperlipidemia.~   "
123209|NCT01442974|"~     Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment.~     Actually, one of the most interesting characteristics of pancreatic cancer is the dense~     fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express~     a specific protein profile different from tumor cells. For example, secreted protein rich in~     cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in~     tumor cells. This characteristic is associated with poor clinical outcome.~      Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC,~     decreases tumor stroma density. Such effect improves drug delivery, and enhances both,~     nab-paclitaxel and gemcitabine, antitumor activity in nude mouse models.~      Based on this pre-clinical data the investigators designed a clinical trial of~     nab-paclitaxel in combination with gemcitabine as neo-adjuvant treatment for pancreatic~     cancer patients. Fifteen, SPARC positive patients, will be enrolled in the study and treated~     with abraxane in combination with gemcitabine.~      This is a pilot study which primary end point is evaluating the effect of Abraxane in~     combination with gemcitabine on tumor stroma, and the secondary end-point is correlating~     these changing with treatment activity.~   "
123210|NCT01442961|"~     The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is~     faster than after abdominal approach. The aim of this study is to evaluate postoperative~     pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid~     consumption.~   "
123211|NCT01442948|"~     Monocytes may be separated into phenotypically and functionally distinct cell types by the~     presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The~     investigators hypothesize that the total numbers of CD16+ monocytes are significantly~     related to cardiovascular outcome in patients with angiographically proven coronary heart~     disease.~   "
123222|NCT01442805|"~     The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the~     treatment of the fear of driving, the fear of flying and the fear of public speaking.~      The study is a randomized controlled trial (RCT) designed to compare the efficiency of~     cognitive behavioural therapy with exposures in imagination to behavioural therapy with~     exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD~     ratings and physiological measures (heart rate, skin conductance, skin temperature,~     breathing frequency, heart rate variability).~      Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments~     with exposures in imagination.~   "
123438|NCT01439971|"~     This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be~     safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and~     will demonstrate evidence of hemostatic activity. This is supported by the preclinical~     findings in hemophilic animal models.~   "
123212|NCT01442935|"~     The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the~     experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi~     chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according~     to K-Ras status of the patient's tumor.~      The secondary objectives are to evaluate the objective response rate (CR and PR) after 4~     cycles of treatment, according the RECIST V1.1 evaluation scale.~        -  the rate of complete remission (CR) at 6 months after the last study treatment (hepatic~          surgery or last chemotherapy cycle).~        -  the specific rates of resection R0, R1, R2.~        -  the complete pathological response Rate,~        -  the relapse-free survival rate in (R0 or R1) resected patients,~        -  the response duration in non-resected patients,~        -  the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be~          evaluated with the Levi scale,~        -  the post operative complications using the DINDO classification,~        -  the progression-free survival (PFS) and overall survival (OS).~      The objectives of the biological study are:~        -  to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF,~          TP53) and genetic amplification related factors (EGFR),~        -  to evaluate patient-related predictive factors in connection with genetic polymorphisms~          (Fc gamma and VEGF receptors),~        -  to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free~          and progression-free survival,~        -  to study circulating of tumor cells as prognostic factor for metastatic colorectal~          cancer, non- resectable at presentation.~   "
123213|NCT01442922|"~     The primary purpose of the study is to establish the degree and duration of pain relief~     following minimally invasive surgery for a painful degenerative disc.~   "
123214|NCT01442909|"~     Both pemetrexed and docetaxel have been reported to have similar activity against non-small~     cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III~     study. However, no study showed different toxicity and efficacy profiles within individual~     patients. Present phase II randomized clinical trial is designed to answer these questions,~     with addition of information about whether or not sequential therapy can prolong~     disease-free and overall survival.~   "
123215|NCT01442896|"~     The purpose of this study is to perform exploratory analyses to evaluate rates of functional~     and structural change in glaucoma, to identify predictors of rapid progression in patients~     with glaucoma and to identify possible genetic factors and biomarkers associated with the~     disease.~   "
123216|NCT01442883|"~     In patients with treatment resistent hypertension renal nerve ablation emerged as an~     effective interventional approach of treating hypertensive disease with a progressively~     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is~     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the~     precise mechanisms that causes the fall in blood pressure in the short-term and, in~     particular, long-term remains elusive. The objective of the study is to understand the~     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic~     nervous system. In 100 hypertensive patients most advanced technology will be applied,~     before and repeatedly after renal denervation, throughout the follow-up period of 1 year.~     Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin~     labelling technique), local activity of the renin angiotensin system in the kidney (urinary~     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI~     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large~     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over~     24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the~     fall in blood pressure after renal denervation may help to identify those hypertensive~     patients that profit most from renal nerve ablation in terms of blood pressure reduction.~      The investigators propose the following hypotheses why a progressive decrease in blood~     pressure happens, in addition to the decreased activity of the central nervous system, after~     renal nerve ablation:~      Short term effects:~      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the~     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation~      Long term effects:~      D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall~     properties after 6 and 12 months~   "
123217|NCT01442870|"~     Metformin is a drug that is normally used to treat people with diabetes. New research has~     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up~     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or~     for causing recurrence of the cancer. Future studies are envisioned to that test the~     efficacy of administering metformin with chemotherapy. The purpose of this study is to~     assess the safety of administering metformin in combination with chemotherapy. Since~     chemotherapy and cancer itself both cause adverse events by themselves, this study is~     designed to have a run-in stage as well as a subsequent randomization to metformin or no~     metformin. The primary endpoint will compare the rate of dose-limiting toxicities between~     these two arms. After a period of 3 weeks for the primary endpoint comparison, all patients~     will receive metformin.~   "
123218|NCT01442857|"~     The axillary region is regularly used for brachial plexus block. The technique may be guided~     by nerve stimulation, ultrasound or a combination of nerve stimulation and ultrasound.~     Magnetic resonance imaging (MRI) has been beneficial in presenting anatomy of interest for~     regional anesthesia and in demonstrating spread of local anesthetic (LA). An axillary~     MRI-study at our department supported the suggestion of multiple rather than a single~     injection technique. Using a 0.5 Tesla open MR scanner in that study, the investigators were~     not able to distinguish terminal nerves from equally sized vessels. Therefore the~     investigators could not definitely answer whether the LA reached the pertinent nerves. The~     investigators have recently performed an axillary block study with a 3.0 Tesla scanner. Now~     the terminal nerves were identified and for each patient the investigators could observe if~     the LA reached the nerves.~      The aim of this study was to demonstrate the anatomy of the brachial plexus in the axillary~     region at different levels. The investigators present the best pictures of the nerves with~     and without LA injected. The images are demonstrated in the axial and coronal plane.~   "
123219|NCT01442844|"~     This study evaluates a novel micrografting technique to see how it will influence the~     healing rate and cosmetic result of second intention wounds. The graft harvesting and~     micrografting process was designed by MoMelan Technologies The Epidermal Expansion System,~     which is composed of a commercially available Blister Generation Device and the Microblister~     Generation and Excision Device (MBGED), will generate an array of small microblisters and~     transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing)~     for application to the subject's surgical area. The investigators predict that applying~     expanded micrografts to wounds that otherwise would have healed by second intention alone~     will hasten healing and possible reduce scarring.~   "
123220|NCT01442831|"~     The purpose of this study is to describe the single dose pharmacokinetics of total~     radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in~     healthy adult male subjects.~   "
123223|NCT01442792|"~     Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat~     patients with obstructive coronary artery disease (CAD). Although PCI is highly effective~     for the management of CAD, it can potentiate an existing prothrombotic state around lesion~     areas. A certain level of anticoagulation is required to perform planned PCI safely and to~     minimize the periprocedural risk of thrombosis and its attendant complications, including~     myocardial ischemia and infarction (heart attack). Many different anti-thrombotic regimens~     have been investigated and are currently in use. The aim of this study is to explore whether~     Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual~     antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic~     events, upon balloon inflation and stent expansion, during elective PCI, without increasing~     bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding~     for randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group.~     However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20~     mg).The 10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.~   "
123224|NCT01442779|"~     The purpose of this study is to determine the possible efficacy of low dose, orally~     administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).~   "
123225|NCT01442766|"~     Stroke is a major personal and social burden, being the commonest cause of severe adult~     disability. Recovery has been shown in animal models to be dependent upon adequate levels of~     acetylcholine within the brain - which in stroke is likely to be deficient. This is because~     acetylcholine-producing nerve cells in the brain are often damaged by strokes. Consequently,~     the investigators hypothesise that recovery may be improved by boosting acetylcholine levels~     in the brain - that can be readily achieved by treating with donepezil.~      AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients~     taking donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes~     as a result of donepezil after 12 weeks.~   "
123226|NCT01442753|"~     The goal of this project is to evaluate the effectiveness of a family-based tobacco use~     prevention intervention directed at immigrant Latino parents of middle school aged youth as~     delivered in partnership with seven community organizations. The primary outcomes of the~     study are youth susceptibility to tobacco use, and changes in parenting practices among the~     parents of the youth. The planning, initiation, and delivery of the intervention will occur~     in collaboration with community organizations that have identified this project as important~     to the families they serve. Though the collaboratively designed training curriculum has been~     successfully tested and a study design for the current project established, a substantive~     development period for this project will allow the research team and collaborating~     organizations to consider key aspects of design and delivery.~   "
123227|NCT01442740|"~     Functional Endoscopic Sinus Surgery (FESS) is normally performed in our centre in a 0-degree~     supine position, with the patient laying flat. This study will be investigating whether~     changing patients to a 15-degree head up, feet down position will improve field of view and~     reduce blood loss during surgery. The 15-degree head up, feet down position has been used in~     other circumstances, such as brain surgery and for severely obese patients where airways can~     be blocked due to lying flat. Every 15 minutes, blood pressure, heart rate and field of view~     according to the Boezaart nasal scope scaling system will be recorded.~   "
123228|NCT01442727|"~     Context: Approximately 100 million people throughout the world consume water contaminated~     with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh~     alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected~     regions. There are no proven therapies for treating chronic arsenic toxicity or for~     preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a~     variety of animal models. The investigators have recently shown in animals and humans that~     this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl)~     arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two~     Phase II studies in China and Bangladesh have suggested clinical benefit to selenium~     supplementation in arsenicosis patients.~      Objective: To assess whether daily selenium supplementation counters arsenic toxicity in~     patients exposed to drinking water arsenic. If proven effective, selenium supplementation~     might be safely and cost-effectively implemented in the worst-affected localities.~   "
123229|NCT01442714|"~     Primary Objective:~      - Determine the lack of disease progression (CR/CRi/PR/HI rate) after 6 cycles of treatment~     with the combination of azacitidine plus lenalidomide in previously treated patients with~     Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (HR-MDS).~      Secondary Objective:~      - Determine the 42-day survival after treatment with this combination in elderly patients~     with previously treated AML/HR-MDS patients~   "
123230|NCT01442701|"~     The investigators intend to investigate whether the rise in childhood obesity is caused by~     the loss of recurrent and chronic infections in modern, industrialized society, beginning in~     utero and extending through early childhood. The investigators will also examine whether the~     antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the~     incidence of infection within a household.~   "
123231|NCT01442688|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
123232|NCT01442675|"~     The purpose of this trial is to describe the safety and antibody response to revaccination~     with Menactra vaccine in persons who received their first dose at ≥11 years of age.~      Primary Objective:~      - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135,~     measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra~     vaccine in subjects who were first vaccinated with Menactra 4-6 years ago.~      Secondary Objective:~      - To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens~     collected 6 days post-vaccination in a subset of study population.~      Observational Objective:~      - To describe the rates of immediate reactions, solicited injection-site and systemic~     reactions, unsolicited adverse events and serious adverse events following vaccination.~   "
123233|NCT01442662|"~     The aim of this research is to study the activity of pazopanib in second line after~     anthracyclines in extra uterus and uterine LMS in association with gemcitabine.~   "
124450|NCT01426698|"~     The purpose of this study is to examine differences in the long-term effects of immediate~     versus delayed cord clamping at birth on developmental outcomes of our study infants at~     18-22 months corrected age.~   "
123234|NCT01442649|"~     The main objective is to evaluate progression-free survival (PFS) at 4 months.~      The secondary objectives are to evaluate the objective response rate (OR) (= complete~     responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the~     progression-free survival (PFS), the overall survival (OS), the overall survival from the~     date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance~     (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the~     quality of life according to the EORTC QLQ-C30 criteria.~      The objectives of the biological study are to evaluate potentially predictive anti-EGFR and~     anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of~     bevacizumab associated with chemotherapy in mCRC treatment.~   "
123235|NCT01442636|"~     The objective of this clinical evaluation is to evaluate the immediate and long term (up to~     12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott~     Vascular) in a controlled prospective investigation for the treatment of patients with~     critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the~     level of the below the knee arteries. Specifically the trial aims to illicit angiographic~     and ultrasound patency, clinical improvement, and adverse events associated with the use of~     this stent. The trial design is single armed, prospective, controlled trial run over 12~     months of follow-up.~   "
123236|NCT01442623|"~     Dizziness is a common and disabling symptom and is associated with unsteadiness in both~     standing and walking, sometimes resulting in falls. People who have any of these problems~     often have a disease process affecting the inner ear. A proportion of people will recover~     spontaneously over time; those that do not may benefit from a specialized form of~     physiotherapy known as vestibular rehabilitation. This consists of exercise regimes that are~     individualized to each person depending on their problems. These regimes aim to decrease~     dizziness, help patients to re-learn movement patterns and improve their balance during~     standing and walking. There is considerable research supporting vestibular rehabilitation~     but it is not clear what is the best type, setting or frequency of treatment. How therapy~     impacts on walking ability is also not clear. Recent developments have suggested that force~     plate and virtual reality therapies may benefit. This form of therapy can provide feedback~     that is unavailable with conventional exercises. Exposure to virtual environments can~     challenge balance which helps to retrain it. The aim of this study is to compare~     conventional vestibular rehabilitation with a force plate/virtual reality therapy based~     vestibular rehabilitation, using a universally available virtual reality system (Nintendo~     Wii Fit Plus®). In this study, consenting patients with a vestibular disorder will be~     assigned randomly to either a conventional treatment or a virtual reality based treatment~     that is customized to their individual problems. They will receive treatment for 8 weeks.~     The effects of treatment will be measured by state of the art computerized analysis of~     walking and balance. Questionnaires that obtain information about how severe their dizziness~     is will also be administered. The study will help therapists understand how inner ear~     problems affect walking and balance. It will also provide information on the optimum method~     of providing vestibular rehabilitation and thus improve patient care.~   "
123237|NCT01442610|"~     As the MAO-B inhibitor rasagiline is able to improve motor skills it might have positive~     effects on sleep disruption by reducing nocturnal akinesia. As it was reported to cause only~     minor sleep disruption in PD Patients, it might be able to improve sleep architecture. The~     investigators thus study the effects of Rasagiline on sleep disturbances measured by~     polysomnographic (PSG) evaluation of sleep efficacy and PDSS-2. Secondary measures are other~     sleep variables measured by PSG, sleep quality and daytime sleepiness assessed by~     standardized scales as well as cognitive function, depression and QoL index.~   "
123238|NCT01442597|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling~     at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping~     skills, presenting examples of effective use of coping skills in a number of realistic~     situations in video form, and providing opportunities for patients to practice and review~     new skills while receiving substance abuse treatment.~   "
123239|NCT01442584|"~     Ovarian transplantation has been shown to restore fertility.~   "
123240|NCT01442571|"~     The proposed research is to examine the effect of injecting a large volume of HA (10cc) at~     the time of post arthroscopy suture removal (9-11 day post surgery), in patients with~     cartilage damage of ICRS grade 2 and above in one of the knee compartments.~   "
123241|NCT01442558|"~     The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial~     plexus blocks for surgical anesthesia~   "
123242|NCT01442545|"~     The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics~     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.~   "
123243|NCT01442532|"~     The purpose of Part 1 of this study is to evaluate the safety, tolerability, and~     pharmacokinetics (PK, how the drug is absorbed in the body, distributed within the body,~     and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo~     following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian~     adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on~     the pharmacokinetics of midazolam in healthy participants.~   "
123244|NCT01442519|"~     Intravesical treatment for superficial bladder cancer has been used for the past 4-5~     decades. Intravesical chemotherapy is beneficial in terms of recurrence and time to~     recurrence in grade 1-2 stage Ta tumours, usually non-invasive. Intravesical chemotherapy~     has negligible effect on disease progression in high-risk superficial bladder cancer—ie,~     grade 3, stage T1, and carcinoma in situ. However, BCG as induction and maintenance~     treatment effectively delays progression. Electromotive mitomycin increases tissue uptake~     compared with that of passive diffusion. Electromotive mitomycin has emerged as an~     alternative or complementary treatment to BCG. The rationale for combining anticancer drugs~     is based on the need to increase efficacy and reduce emergence of resistant malignant cells.~     This approach is not frequently applied to use of intravesical agents for treatment of~     superficial bladder cancer, for which immunotherapeutic BCG and chemotherapeutic mitomycin~     seem to be a potentially effective combination. Studies have addressed concurrent use of~     mitomycin and BCG, and assigned two roles to mitomycin: antitumor action and~     tissue-scarifying (ie, surface-modifying) effect that enables BCG to attach more efficiently~     to the urothelium. The investigators therefore aimed to assess whether induction of~     inflammation by use of BCG before mitomycin treatment makes the bladder mucosa more~     permeable and thus enables mitomycin to reach the target more easily. This randomised trial~     to compare the efficacy of sequential BCG and electromotive mitomycin with that of the~     current standard of BCG alone for patients with high-risk superficial bladder cancer.~      After transurethral resection and multiple biopsies patients with stage pT1 bladder cancer~     are randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks; or to 81~     mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive~     mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for~     three cycles (n=107). Complete responders underwent maintenance treatment: those assigned~     BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG~     and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg~     BCG once a month as one cycle for three cycles. The primary endpoint was disease-free~     interval; secondary endpoints were time to progression; overall survival; and~     disease-specific survival. Analyses were intention to treat.~   "
123439|NCT01439958|"~     The purpose of this study is to evaluate long-term safety of L-CsA in prevention of~     bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients~     previously enrolled in phase II/III L-CsA clinical trial 12011.201.~   "
124543|NCT01425463|"~     To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate~     Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron~     Deficiency Anemia.~   "
123245|NCT01442506|"~     Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's~     esophagus. Chromoendoscopy after local acetic acid application enables recognition of the~     mucosal surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+~     resolution above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in~     conjunction with i-Scan or acetic acid to diagnose Barrett`s esophagus. The primary endpoint~     of the current prospective study is to investigate the diagnostic yield of virtual~     chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and~     4-quadrant biopsies.~      Patients with visible columnar lined lower esophagus (CLE) are included. After standardized~     PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo~     either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are~     taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies~     are taken.~   "
123246|NCT01442493|"~     The purpose of the study is to determine whether a change in the rules and staff roles in~     methadone treatment programs will result in greater lengths of stay in treatment and lower~     rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone~     treatment as usual.~   "
123247|NCT01442480|"~     Exposure to ambient levels of air pollution increases cardiovascular morbidity and~     mortality. Advanced age is among the factors associated with susceptibility to the adverse~     effects of air pollution. Dietary fatty acid supplementation has been shown to decrease~     cardiovascular risk through multiple mechanisms. This study evaluated the efficacy of~     supplementation with marine fish oil or olive oil in protecting against cardiovascular~     effects induced by controlled exposure of middle-aged healthy volunteers to concentrated~     ambient air pollution particles. Subjects (ages 50 to72 years), were randomly assigned to~     receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or~     olive oil (3g/d) for 28 d. Subjects were then exposed to concentrated ambient air pollution~     particles or filtered air for 2 hr on sequential days. Heart rate variability (HRV), plasma~     lipids, coagulation markers, and endothelial function measured by flow-mediated dilation of~     the brachial artery (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.~   "
123248|NCT01442467|"~     This study aims to evaluate the accuracy of the echocardiographic data obtained from~     patients with calcifications in the mitral valve who are undergoing a cardiac (heart)~     catheterization.~      Echocardiography is a non-invasive (does not break the skin) procedure used to see an image~     of the heart. It uses harmless sound waves to create an image of the heart on a computer~     screen. These images will show the valves of the heart, how well the heart is pumping blood,~     the blood flow across these valves and how large the heart is. A silver paddle-shaped device~     is moved easily over the skin to capture these images.~      Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding~     the valves) is a common finding and it increases with age. The presence of calcification~     changes the blood flow through the heart valves. This makes any echocardiographic data~     (information) obtained from patients with calcifications difficult to interpret.~   "
123249|NCT01442454|"~     The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic~     pancreatitis with surgical pathology.~   "
123250|NCT01442441|"~     In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS)~     criteria for diagnosing chronic pancreatitis can be correlated with pathologic~     characteristics of tissues taken from pancreas of patients with suspected chronic~     pancreatitis.~      This will be a retrospective study which will examine results from biopsy specimens and~     endoscopic ultrasound findings in suspected chronic pancreatitis.~   "
123251|NCT01442428|"~     Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons~     worldwide, including in South East Asia. Significant numbers of patients experience~     tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after~     ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent~     randomized-controlled trial showed the benefit of prednisone over placebo in reduction of~     days of hospitalization and invasive procedures. The investigators hypothesize that~     nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for~     treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that~     adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase~     inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a~     2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins~     for the symptomatic and immunologic control of TB-IRIS.~   "
123252|NCT01442415|"~     Childhood cancer survivors (CCS) are prone to develop obesity and are at increased risk of~     developing cardiovascular disease and type 2 diabetes compared to the general pediatric~     population. Few lifestyle modification trials have been conducted in overweight/obese CCS~     and it is unclear whether CCS respond similarly to lifestyle modification compared to~     overweight/obese individuals who have not had cancer (non-CCS). We propose a 3-year pilot~     study that will enroll separate cohorts of overweight/obese CCS and overweight/obese non-CCS~     every September into a family-based lifestyle modification program consisting of weekly~     sessions at the University of Minnesota. The goal of the program will be to facilitate~     improved physical fitness, weight management, heart health, and quality of life.~   "
123253|NCT01442402|"~     Aim 1:~      Determine if there is an association between the APOL1 risk variants and allograft survival~     and function in African Americans~      Aim 2:~      Determine if there is an association between the presence of APOL1 risk variants in an~     African American kidney transplant recipient and the risk of recurrent disease~      Aim 3:~      Investigate mechanisms of APOL1 associated kidney disease by prospectively following African~     American kidney transplant recipients throughout their clinical course.~   "
123254|NCT01442376|"~     The primary objective is to evaluate the efficacy of two different doses of IV palonosetron~     in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients~     through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles.~     The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in~     pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of~     pediatric CINV patients.~   "
123255|NCT01442363|"~     This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is~     designed to determine the effects of BLI-1300 ointment on perianal pain associated with~     active Perianal Crohn's Disease (PCD).~   "
123256|NCT01442350|"~     The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000~     individuals in general population. It is generally diagnosed in advanced stages of the~     disease, because it presents clinical features very similar to the hypertrophic~     cardiomyopathy ones, making difficult the correct diagnosis. In Fabry disease there is a~     remodeling process of the myocardial interstitium and apoptosis of myocytes which leads to~     fibrosis development and later systolic dysfunction. The investigators propose to evaluate~     the utility of several biomarkers in the diagnosis of this cardiomyopathy, to facilitate the~     early diagnosis, which is clue to establish early enzyme replacement therapy or intensify~     the patients' follow up. In order to achieve this objective, the investigators will analyze~     markers of endothelial dysfunction, fibrosis and apoptosis in peripheral blood samples of~     patients carrying the mutation but without clinical manifestations and the investigators~     will compare their levels with dose obtained from two different control groups: diagnosed~     patients presenting clinical manifestations or index cases and healthy controls without~     carrying the mutation.~   "
123257|NCT01442337|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of a single~     intravenous dose of ASP8597 in kidney transplant recipients.~   "
123258|NCT01442324|"~     Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation~     (IRE) as the sole treatment of nodules not considered treatable by resection or thermal~     ablation.~   "
123259|NCT01442311|"~     Drug users account for a disproportionately large burden of hepatitis C virus (HCV)~     infection. However, HCV treatment adherence rates in drug users may be suboptimal in~     patients who use drugs regularly during HCV treatment. Because HCV treatment is most~     effective when patients adhere to at least 80% of the prescribed treatment regimen,~     interventions to improve HCV treatment adherence need to be developed and evaluated. The~     investigators designed the HCV DOT trial to test the efficacy of two versions of modified~     directly observed HCV therapy provided on-site at a methadone clinic. The primary objective~     of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a~     plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly~     provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for~     increasing adherence and improving HCV treatment outcomes. The investigators hypothesize~     that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral~     response compared with PEG-DOT.~   "
123260|NCT01442298|"~     The use of bloodless field is a helpful and important method in orthopedic surgery. The~     surgery can be done without interrupting bleedings, while keeping an exact overlook of the~     anatomy. However the method is not without risks, and complications of various kind may~     occur. One of the most important factors to minimise the risk of complications, is to keep~     the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated~     neuromuscular abnormalities after bloodless field among many patients which may lead to a~     prolonged rehabilitation period since they cause a postoperative weakness in the muscles.~     Although in these studies an unnecessary high tourniquet pressures were used and the EMG~     tests were made 6 weeks and 6 months after the surgery.~      With today's demand for fast rehabilitation, there is a need for better knowledge if lower~     tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.~      Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood~     flow. It accounts for a patients limb and vessel characteristics and the type and fit of the~     tourniquet cuff. The method has developed and is now simplified, by using an automatic~     (plethysmographic) sensor placed on the second toe on the involved limb, and after~     administration of anaesthesia, and immediately before limb preparation and draping it~     measures the limb occlusion pressure.~      When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP~     pressure measured. The LOP method is still rarely used it has been seen as difficult and~     time consuming.~      The primary aim of this study is to investigate whether you can reduce the used tourniquet~     pressure with the new LOP measurement technique and still have a adequate bloodless field;~     and if this will lead to any clinical difference regarding postoperative pain. The secondary~     aim is to investigate the difference between the test groups concerning muscle function and~     wound healing and if these are remaining and of clinical importance. The third aim is to~     study how common neuromuscular abnormalities are after the use of bloodless field with lower~     cuff pressures and if there are any differences between the standard method and the LOP~     method.~   "
123261|NCT01442285|"~     The purpose of this study is to understand more about meeting the psychosocial needs of~     people who have cancer.~   "
123262|NCT01442272|"~     The purpose of this study is to determine the value the additional antiproteinuric effects~     of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV,~     with lack of vitamin D and residual proteinuria higher 0,5 grams/day.~   "
123263|NCT01442259|"~     The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in~     subjects with a different degree of renal impairment.~   "
123264|NCT01442246|"~     PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to~     10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24~     months after radical prostatectomy in patients with high risk of recurrence.~      SECONDARY OBJECTIVE(S):~        -  PSA evolution~        -  Evaluation of testosterone level~        -  Specific survival~        -  Overall survival~        -  Tolerance~        -  Quality of life (QLQ-C30 questionnaires)~   "
123265|NCT01442233|"~     In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual~     disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used~     but there is no established evidence of their efficacy.~   "
123266|NCT01442220|"~     Pituitary adenomas is a very common disease, but the cause and genetics hasn't been~     identified. The investigators are going to use genome-wide association study to identify~     genes that may be related to pituitary adenomas.~   "
123267|NCT01442207|"~     The purpose of the study is to compare the role of cervical cerclage versus expectant~     management in women with complete placenta previa (≥ 10mm over internal os) presenting with~     shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.~   "
123268|NCT01442194|"~     The purpose of this world-wide prospective parallel-cohort study in patients with relapsing~     forms of MS, either newly treated with fingolimod or receiving another disease-modifying~     therapy, is to further explore the incidence of selected safety- related outcomes and to~     further monitor the overall safety profile of fingolimod under conditions of routine medical~     practice.~   "
123269|NCT01442181|"~     The purpose of this study is to compare a minimally invasive surgical procedure and~     medication management in stroke patients with Atrial Fibrillation. The two treatment options~     are a minimally invasive surgical procedure or the use of medications.~   "
123440|NCT01439945|"~     RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of~     breast cancer.~      PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of~     magnesium oxide works compared to placebo in treating menopausal women with hot flashes and~     a history of breast cancer.~   "
123272|NCT01442142|"~     The objective of this study is to pilot test, evaluate and compare the effects of Cue~     Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT)~     in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce~     eating in the absence of hunger in overweight children immediately following treatment and~     6-months post treatment.~      The primary aim of this proposed study is to evaluate the efficacy and compare the~     effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite~     Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight~     children. Following this first intervention, a second intervention to determine the efficacy~     of a combination program (combined CAAT & CRST) will be implemented.~      The secondary aim of this study is to evaluate change in the following related measures for~     both children and adults who participated in CRST, CAAT, and the combination program: BMI~     for age, food intake, perceptions of control over eating, and self-efficacy in managing~     high-risk food situations.~   "
123273|NCT01442129|"~     The main purpose of this research is to determine whether injecting mesenchymal precursor~     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)~     is safe. MPCs are normally present in human bone marrow, and have been shown to increase the~     development of blood vessels and new heart muscle cells in the heart. In addition, this~     research is being done to test whether injecting the MPCs into the heart is effective in~     improving heart function.~   "
123274|NCT01442116|"~     The study hypothesis is stress-related regional tissue dynamics is related to left~     ventricular outflow tract blood flow.~   "
123275|NCT01442103|"~     This investigation will be conducted in the US as a single-center study to evaluate in total~     10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.~   "
123276|NCT01442090|"~     Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with~     metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will~     be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.~   "
123277|NCT01442077|"~     Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of~     new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who~     respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.~   "
123278|NCT01442064|"~     This is an open-label, multicenter, extension study of intravitreally administered~     ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g,~     NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV)~     secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a~     Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g~     (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema~     secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month~     observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018)~     or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the~     previous study.~   "
123279|NCT01442051|"~     The purpose of this study is to help us learn how to lower the risk of a blood transfusion~     during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a~     technique performed in the operating room before the procedure begins that may reduce the~     risk of needing a transfusion during ovarian cancer surgery. During surgery, the patient's~     own blood is given back to them when needed, usually due to bleeding. If you don't need~     blood during surgery, your own blood will be given back at the end of the case.~      The idea behind ANH is that that by removing the blood and replacing it with other fluids,~     the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually~     due to bleeding. The original non-diluted blood is then transfused back as needed. This may~     mean a lower chance of needing an additional blood transfusion.~      ANH has been studied at this hospital for other types of cancer. These studies suggest that~     ANH may help conserve blood. Although most studies suggest that ANH can be performed safely,~     one study showed that ANH could be associated with a higher rate of serious bowel~     complications than standard treatment. In this study, patients who underwent ANH had a~     higher rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two~     ends of bowel that have been cut and sewn back together (the anastomosis), fall apart. The~     investigators don't know whether ANH will result in higher rates of anastomotic leaks in~     patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients~     having the kind of bowel resections that often occur in ovarian cancer surgery (the colon),~     no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC~     are conducting a study to find out if ANH can be used safely in patients undergoing surgery~     for ovarian cancer.~   "
123280|NCT01442038|"~     This study will evaluate the efficacy of ranolazine as compared with placebo when used as~     part of standard medical therapy in chronic angina subjects with incomplete~     revascularization post-percutaneous coronary intervention (PCI; formerly known as~     angioplasty with stent) on the composite of ischemia-driven revascularization or~     ischemia-driven hospitalization without revascularization.~   "
123281|NCT01442025|"~     To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab)~     trough level measurements and adjustment of dosing based upon these levels by means of two~     different standardized algorithms in comparison with 'standard of care' IFX treatment and~     its effects on clinical and endoscopic outcomes.~   "
123282|NCT01442012|"~     To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting~     (PONV) in Ambulatory Surgery.~   "
123283|NCT01441999|"~     The treatment of adult deformity has improved with the development and use of modern~     segmental instrumentation, including posterior instrumentation. However, the incidence of~     proximal junctional kyphosis (PJK) caused by the accelerated degeneration of the joint~     capsules and smaller articular processes in the proximal junctional region has also been~     noted.~      One potential way of decreasing PJK is to decrease the structural rigidity of the construct~     at the top thereby providing a transition to the non-instrumented spine and allowing for~     less facet capsule and muscle disruption.~   "
123284|NCT01441986|"~     The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine~     compared to placebo exert blood glucose (BG) lowering effects following an oral glucose~     tolerance test (OGTT) in male subjects with T2DM.~   "
123285|NCT01441973|"~     The purpose of this study is to determine whether elotuzumab will improve response in~     patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the~     health of the body's immune system)~   "
123471|NCT01439542|"~     The purpose of this study is to examine the safety of a shorter course of radiation~     treatments combined with one year of androgen deprivation therapy. The study will test this~     treatment in men with high risk prostate cancer who have significant other illnesses or~     circumstances such that conventional long term radiotherapy and hormone therapy is not~     recommended by their physician or desired by the patient.~   "
123286|NCT01441960|"~     Electroconvulsive therapy (ECT) is the transcutaneous application of small electrical~     stimuli to the brain to produce generalized seizures for the treatment of selected~     psychiatric disorders such as severe depression. The aim of ECT is to induce a therapeutic~     tonic seizure where the person loses consciousness and has convulsions. Patients need~     general anesthesia and neuromuscular blockade to treat pain and avoid excessive tonic clonic~     motor contraction that might be associated with compression fractures. Neuromuscular~     blocking drugs (NMBD) are, therefore, administered after induction of general anesthesia to~     induce neuromuscular blockade. Despite the importance of NMBDs to provide optimal conditions~     for ECT treatment, the optimal NMBD dose to achieve acceptable neuromuscular blockade~     without excessive or untoward effects has not previously been identified in any study and in~     a prospective randomized fashion. The aim of this study is, therefore, to identify the~     optimal NMBD dose of two commonly used neuromuscular blocking agents (succinylcholine and~     rocuronium) in order to optimize the muscle strength modulation during ECT that facilitates~     ECT with the minimal side effects.~   "
123287|NCT01441947|"~     The study drug cabozantinib works by inhibiting several different proteins which are~     believed to be involved in breast cancer tumor growth, its ability to spread, and its~     ability to form new blood vessels. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to prevent~     cancer growth.~      The single agent portion of this study is now closed to accrual. This research study is now~     examining the efficacy of cabozantinib in combination with fulvestrant for treatment of~     hormone-receptor-positive breast cancer that has spread to bone.~   "
123288|NCT01441934|"~     Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary~     diseases, and it is an independent prognostic factor, until now no evidence-based treatment~     approach exists for those patients.~      This study will address if the drug sildenafil can lower pulmonary vascular resistance in~     patients with significant pulmonary hypertension (high blood pressure in the lungs)~     associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment~     can improve effort capacity, quality of life without causing a deterioration in pulmonary~     gas exchange (mainly arterial oxygenation).~      Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean~     pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are~     randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.~      Before starting treatment (baseline), and a the end of the study, the patients have a~     comprehensive assessment including:~        -  a chest x-ray and CT scan (only at baseline);~        -  pulmonary function tests to measure how much air the patient can breathe in and out,~          and the capacity of diffusion of gases;~        -  arterial blood gases analysis (for safety reason this examination is performed at~          baseline, before the randomization after one hour from the administration of a tablet~          (20 mg) of sildenafil, and every month)~        -  an echocardiogram (heart ultrasound) (only at baseline);~        -  a 6-minute walk test to measure exercise capacity;~        -  a quality-of-life assessment (SF-36 questionnaire)~        -  a right heart catheterization to evaluate the severity of hypertension~      At the end of the 16-week period, patients may opt to continue to receive sildenafil and~     monitoring in an open-label phase of the study for up to 1 year.~   "
123289|NCT01441921|"~     Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance~     status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated~     abnormalities.~   "
123290|NCT01441908|"~     The primary objective of this study is to determine any changes in cardiovascular risk among~     individuals receiving a statin by assessing their multi-analyte profile.~   "
123291|NCT01441895|"~     The study objective is to assess changes in corneal sensation and dry eye signs and symptoms~     following cataract extraction/femtosecond arcuate relaxing incisions.~      Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond~     arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or~     worsening of dry eye signs and symptoms.~   "
123292|NCT01441882|"~     This phase II trial studies how well dasatinib works in treating patients with chronic~     lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth.~   "
123293|NCT01441869|"~     Study in healthy subjects to measure amount of drug in blood after dosing with different~     saxagliptin / metformin products.~   "
123294|NCT01441856|"~     The added value of the laparoscopic hemihepatectomy compared to the open hemihepatectomy has~     never been studied in a randomized controlled setting. Therefore, the multicenter~     international ORANGE II PLUS - trial has been constructed and will provide evidence on the~     merits of laparoscopic versus open hemihepatectomy in terms of time to functional recovery,~     hospital length of stay, intraoperative blood loss, operation time, resection margin, time~     to adjuvant chemotherapy initiation, readmission percentage, (liver-specific) morbidity,~     quality of life, body image, reasons for delay of discharge after functional recovery, long~     term incidence of incisional hernias, hospital and societal costs during one year and~     overall five-year survival.~   "
123295|NCT01441843|"~     The purpose of this study is to determine whether lorazepam, which is used to lower~     preoperative anxiety, also improves postoperative recovery.~      This study data will also be used for further research aiming to identify vulnerable~     patients in the day-case surgery setting.~   "
123296|NCT01441830|"~     The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave~     therapy) combined with supervised exercises will improve function and reduce pain in~     subacromial shoulder pain compared with supervised exercises alone.~   "
123297|NCT01441817|"~     The purpose of this study was to determine if internal fixation of the medial malleolus is~     necessary following open reduction and internal fixation of the lateral and, if required,~     the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.~   "
123298|NCT01441804|"~     Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response~     to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that~     there is no important difference in effect between the two treatment effect.~   "
123491|NCT01439282|"~     This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in~     combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65~     subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal,~     estrogen receptor (ER)-positive breast cancer.~   "
123299|NCT01441791|"~     The purpose of this international, multicentre, double-blinded randomized controlled trial~     is to determine if the open lung approach providing recruitment maneuvers and~     PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis~     formation and improves respiratory function in the immediate post-operative period after~     major abdominal surgery.~      Participating centres throughout the world will include a total of 900 adult patients~     undergoing general anesthesia for open abdominal surgery with high or intermediate risk for~     post-operative pulmonary complications. Patients are randomized and intra-operatively~     ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment~     maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment~     maneuvers). Patients will be assessed on the first 5 post-operative days, on day of~     discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary~     complication (see below). Secondary endpoints are post-operative extra-pulmonary~     complications, intra-operative mechanical ventilation related complications, unscheduled ICU~     (Intensive Care Unit) (re-) admission, and length of hospital stay.~   "
123300|NCT01441778|"~     The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is~     superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms~     in children with allergic rhinitis.~   "
123301|NCT01441765|"~     CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug~     that are known to target specific cells (in this case, cells in the immune system) The DC~     RCC Vaccine is agent that tries to help the immune system to recognize and fight against~     cancer cells.~      The purpose of this research study is to determine the safety of CT-011 alone, and in~     combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators~     are also trying to find out what effect the combination has on the disease, and on your~     immune system.~   "
123302|NCT01441752|"~     The investigators performed a multi-center, randomized, controlled, double-blind,~     prospective study on evaluating effect of chemotherapy combined with or without integrated~     TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients.~     The investigators plan to involve 600 cases for observation in 3 years (300 cases for each~     group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM~     combined with chemotherapy compared to that by chemotherapy alone.~   "
123303|NCT01441739|"~     Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity~     and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present~     a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are~     non-specific and indistinguishable from other gastrointestinal disorders and sepsis.~      The first goal of this study is to find and evaluate tests to diagnose NEC at an early~     stage. For the development of new diagnostic markers, the investigators require knowledge of~     pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the~     second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of~     the pathophysiology of NEC can offer the possibility to develop new therapeutical~     treatments.~   "
123304|NCT01441726|"~     Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other~     related dementia are increasingly prevalent in older people. At an advanced stage,~     institutionalization in a long-term care (LTC) setting will be the fate of a majority of~     patients. A structured palliative care approach is increasingly used for cancer patients,~     but is still rarely accessible in LTC institutions for older people with advanced or~     terminal dementia. This approach should include a more systematic detection and treatment of~     pain and other physical and psychological symptoms during the last weeks of life, as well as~     better communications between patients, families and care staff, particularly relating to~     advanced care directives. Objectives: The general objective of this study is to implement~     and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life~     care for older persons with terminal dementia in LTC facilities. Methodology: The~     intervention program will include five components:~        1. daily involvement of a nurse from the regular staff in the LTC facility as a change~          agent;~        2. awareness sessions with administrators and staff on the importance of high quality~          palliative care in dementia;~        3. a training program for physicians and all the staff involved in direct care of~          patients;~        4. systematic discussions with families and distribution to families of a document on~          different aspects of palliative care in dementia;~        5. systematic clinical care by regular staff for the control of pain, respiratory symptoms~          and mouth care. The program will be implemented in two LTC settings (one in Quebec City~          and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC~          control settings where usual care will be applied without implementation of the~          program.~   "
123305|NCT01441713|"~     Patients with advanced prostate cancer usually receive some kind of pharmaceutical~     castration or undergo surgical castration. At the investigators department the~     pharmaceutical treatment is most often given with a 3 month interval.~      Over the last few years new drugs, which allow for lees frequent treatment, have been~     developed. The purpose of this study is to assess how the treatment affects patients and if~     our current patients would prefer to receive treatment at different intervals than they do~     at the present time. At the same time the investigators will assess how surgical treatment~     affects our patients. This will be assessed by patient questionnaires administered at our~     clinic.~   "
123306|NCT01441700|"~     Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss~     of monitoring in patients undergoing lumbar disc surgery extubated in prone position and~     supine position.~   "
123307|NCT01441687|"~     This randomized pilot phase I trial studies the best way, either expressed prostatic~     secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in~     patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help~     doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more~     effective in predicting prostate biopsy results~   "
123308|NCT01441674|"~     The primary purpose for this study is to determine if children who receive Occupational~     Therapy while they are an inpatient in the hospital will be more motivated to participate in~     therapy as well as increase the amount of time they will work during that particular session~     when a therapy dog is present during their sessions. The investigators will also be~     collecting data regarding a child's heart rate and blood pressure prior to the session~     starting and ending to determine if having a therapy dog present also helps relax a child.~   "
123309|NCT01441661|"~     This non-interventional study includes patients with advanced renal cell carcinoma who are~     treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial~     is to increase knowledge about usage, dosage, efficacy and safety under conditions of~     routine use of Sunitinib.~   "
123562|NCT01438359|"~     The purpose of this study is to determine if Furosemide is affected by PA21.~   "
123310|NCT01441648|"~     More than 1 million people worldwide wear soft contact lenses for refractive error~     correction. However, severe sight threatening complications due to contact lens wear such as~     contact lens-related microbial keratitis (CLMK) are about 1 per 2500 persons per year. The~     rate of infection increases drastically to 1 per 500 person per year if lenses were worn~     overnight. Recently, color tinted cosmetic soft contact lenses, which are essentially soft~     contact lenses with a color tinted annular ring, are gaining increasing popularity~     especially among the younger and Asian population desiring a change in iris color or the~     doll-eyed look. However, studies on the effect of these lenses on the ocular surface have~     been scarce. Recently, a report of 12 cases of lens-related microbial keratitis due to wear~     of the color tinted lenses have been reported. Others reported of decreased contrast~     sensitivity, increased higher order aberrations, and temporary changes in corneal topography~     due to color tinted lens wear. Nevertheless, comprehensive and prospective study has not yet~     been done. Thus, the purpose of this study is to conduct a prospective observational study~     to determine the influence of color tinted cosmetic contact lens wear both on visual~     performance and ocular surface alterations.~   "
123311|NCT01441635|"~     The purpose of this proof-of-concept study is to determine whether elagolix (ABT-620) is~     safe and effective in the treatment of pre-menopausal women, 20 to 49 years of age, with~     heavy uterine bleeding associated with uterine fibroids. The effect of elagolix (ABT-620) on~     uterine size, fibroid size, and bleeding associated with uterine fibroids will be assessed~     versus placebo, and in combination with add-back therapy.~   "
123312|NCT01441622|"~     Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with~     Obstructive Sleep Apnea Syndrome (OSAS).~      The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during~     attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.~   "
123313|NCT01441609|"~     An observational study will be performed in subjects aged 3-65 years old to describe the~     dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find~     out the expression levels of Th9 cells and IL9 in subjects with different response to the~     primary immunization (3 single -dose injunctions).~   "
123314|NCT01441596|"~     The aim of this study is to investigate the efficacy and safety of afatinib alone or in~     combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic~     breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based~     therapy~   "
123315|NCT01441583|"~     The purpose of the IVORY Study is to gather data to support global submissions/approvals for~     some models of the Ingenio device family.~   "
123316|NCT01441570|"~     In an open label analysis, nebivolol has been shown to have a positive impact on quality of~     life in the general hypertensive population. That is, patients treated with nebivolol~     reported less side effects compared to those treated with metoprolol. Also, more nebivolol~     treated patients reached normalization of blood pressure. Although there is no data, it is~     believed that the impact would be similar in renal transplant recipients.~      The primary goal of this study is to determine if nebivolol will improve the quality of life~     measurements of kidney transplant recipients as compared to those treated with metoprolol~     succinate. This will be measured by comparing the scores of four quality of life~     questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of~     this study are to determine if the use of nebivolol is cost-effective in the renal~     transplant recipient; determine if there is a change in urine protein excretion and renal~     function with the use of nebivolol; and determine the number of patients that maintain or~     achieve a target blood pressure of ≤ 120/80 mmHg.~   "
123317|NCT01441557|"~     Main objectives:~      Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in~     severe botulinic poisoning in measuring the effect on electrophysiological and respiratory~     parameters~      Secondary Objective:~      Study the natural history of electrophysiological and respiratory parameters during the~     botulinic intoxication~      Primary endpoint:~      Clinical, electrophysiological and respiratory before and after administration of~     3,4-diaminopyridine.~      Study Design:~      Pilot study, prospective, interventional.~      Study population:~      Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with~     no other organ failure~      Experimental treatment :~      3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according~     to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.~      Statistics:~      Intra-individual comparison of physiological parameters measured before and after~     administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be~     measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be~     administrated. If this dose is well tolerated and provides a relative improvement of 10% for~     at least one of the parameters studied, the dose will be maintained at 10 mg for 48 hours 3~     times a day then increased to 20 mg.~      The primary endpoint is the change in the amplitude of muscle response evaluated by the~     subtraction of amplitude at T1.5 and T0.~   "
123318|NCT01441544|"~     Increasing physical activity continues to be a challenge among many individuals,~     particularly those who are overweight. Recent data from the National Health and Nutrition~     Examination Survey (NHANES) showed that individuals who reported engaging in a variety of~     activities were more likely to meet national physical activity recommendations compared to~     those who reported no variety. Incorporating a variety of activities into a physical~     activity program may be a way to increase physical increase physical activity levels.~      One method to increase variety in physical activities is to use active videogames.~     Videogames that use motion sensors allow a gamer to physically perform a variety of~     activities. Thus, the purpose ot this laboratory-based investigation is to conduct a study~     to examine the effect of engaging in a greater variety of active videogames on energy~     expenditure in 30 non-obese, regularly active adults.~   "
123319|NCT01441531|"~     The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po)~     before surgery will help prevent the development of tourniquet pain and hypertension while~     the tourniquet is inflated during orif of tibia fracture.~   "
123563|NCT01438346|"~     This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging~     (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse~     treatment program. The main hypothesis is that MBB will be more effective than the control~     (standard) intervention program in helping people reduce their craving for illicit~     substances and/or alcohol.~   "
123320|NCT01441518|"~     Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with~     increased perinatal and maternal complications. The most serious maternal complication is~     the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal~     complications include fetal macrosomia with consequent increased risk of obstetrical trauma~     and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and~     metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational~     hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For~     the tight control of blood glucose, pregnant women are treated as home care (outpatient) or~     hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus~     hospital care of gestational diabetes and mild gestational hyperglycemia.~   "
123321|NCT01441505|"~     Recently, interest has emerged in the use of ketamine as an antidepressant. Recent~     placebo-controlled clinical trials administering a single dose and an open label trial~     giving repeated doses shown that ketamine is markedly superior to placebo at reducing~     depression, including in treatment-resistant patients, and that its antidepressant effects~     have a very rapid onset.~      This clinical study consists of two phases. In Phase I, participants who satisfy inclusion~     criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline,~     or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase~     II, they will receive repeated sessions of ketamine at variable doses over three weeks.~     During both phases, mood, psychiatric, and neuropsychological outcomes will be measured.~   "
123322|NCT01441492|"~     This randomized prospective trial is designed to test the hypothesis that pancreatectomy~     without routine intraperitoneal drainage does not increase the severity or frequency of~     complications within 60 days of surgery.~   "
123323|NCT01441479|"~     The purpose of this study is to demonstrate the ability of the Strep A Fluorescent~     Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence~     of Strep A when compared to culture.~   "
123324|NCT01441466|"~     The purpose of this study is to investigate the effect of cohort isolation of RS(respiratory~     syncytial virus)-positive bronchiolitis versus RS-negative bronchiolitis on prevention of~     co-infection and clinical disease severity. Furthermore the investigators want to elucidate~     general epidemiological data on bronchiolitis concerning viral causes and the associated~     clinical severity.~      The investigators want to conduct a prospective cohort study, comparing incidence of~     co-infection and clinical severity, in two cohort: one with isolation of RS positive~     bronchiolitis as a separate cohort within bronchiolitis and one without isolation (all~     children with RS-negative bronchiolitis are nursed together independent of viral agent)~   "
123325|NCT01441453|"~     The purpose of this study is to determine whether liver transient elastography performed~     before the surgical procedure is able to predict liver failure in patients undergoing~     hepatectomy for hepatocellular carcinoma.~   "
123326|NCT01441440|"~     This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel~     group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and~     venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study~     consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The~     follow-up visit will be evaluated after 2 weeks of last study medication dosing.~   "
123327|NCT01441427|"~     With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors~     ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and~     necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating~     Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human~     developmental biology. Among these roles, they have trophic actions on villous height and~     bowel length of the developing intestine.The aim of this study is to evaluate the efficacy~     of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding~     intolerance and /or NEC in preterm infants.~   "
123328|NCT01441414|"~     To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib~     (AG-013736) in patients that have received one prior systemic regimen for metastatic renal~     cell carcinoma (mRCC) vs. axitinib alone.~   "
123329|NCT01441401|"~     This investigation aims to understand the following issues in pediatric patients, as well as~     to assess the need of a special investigation and a post-marketing clinical study:~        -  The frequency of treatment related adverse events.~        -  The frequency of efficacy assessment.~        -  Treatment related unlisted adverse events in Japanese Package Insert.~        -  Risk factors likely to affect the frequency of treatment related adverse event.~   "
123330|NCT01441388|"~     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of~     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment~     while the majority of patients will eventually develop evasive resistance and exhibit~     disease progression while on therapy. It is proposed that mesenchymal-epithelial transition~     factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute~     significantly to VEGF inhibitor resistance such that combining a c-MET inhibitor with a VEGF~     inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This~     hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with~     individual VEGF inhibitors. Three combinations will be prioritized, namely crizotinib plus~     axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth~     combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with~     either axitinib and/or sunitinib.~   "
123331|NCT01441375|"~     This study is a retrospective chart review of sickle cell patients and will include patients~     whom have received blood transfusions and those whom have not. Of the transfused patients,~     it will also include those whom have received chelation therapy and those whom have not.~   "
123332|NCT01441362|"~     The purpose of this study is to devise the method to reduce laryngeal injuries during~     double-lumen tube intubation.~   "
123333|NCT01441349|"~     The purpose of this study is to compare the efficacy of Simvastatin and Irinotecan/Cisplatin~     chemotherapy with Irinotecan/Cisplatin chemotherapy alone in Extensive disease-small cell~     lung cancer.~   "
123334|NCT01441336|"~     Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric~     cancer, there have been few reports of the efficacy of LAG in the management of advanced~     gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and~     oncologic safety of laparoscopic gastrectomy for AGC.~   "
123335|NCT01441323|"~     The investigators are conducting an intervention study to examine the effects of a 16-week~     exercise and diet interventions on prevention of disease, specifically type 2 diabetes and~     heart disease, in African American youth. Sixty overweight Latino boys and girls will be~     recruited and placed in one of the following intervention groups: 1) Control Group (delayed~     intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar &~     soda, increased fiber & whole grain intake), or 3) Combination of Strength Training~     (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary~     Education (nutrition education focused on reducing sugar & soda, increased fiber & whole~     grain intake). The investigators will assess which intervention group has the most effects~     on health parameters such as weight, body composition, and insulin related measures.~   "
123336|NCT01441310|"~     There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer~     sentinel node mapping.~      The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy~     with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green~     (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.~   "
123337|NCT01441297|"~     Although chemotherapy is the primary treatment option for small cell lung cancer (SCLC),~     longterm survival is rare. SCLC is initially chemosensitive, but rapidly relapses in a~     chemoresistant form with an overall survival of <5%. Consequently, novel therapies are~     urgently required and will likely arise from an improved understanding of the disease~     biology. Some preclinical studies have showed that fibroblast growth factor-2 induces~     proliferation and~   "
123338|NCT01441284|"~     Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter~     study evaluating the efficacy of pramipexole on essential tremor.~   "
123339|NCT01441271|"~     The investigators hypothesize that minimally invasive ileal diversion with intraoperative~     colonic lavage using a high volume polyethylene glycol/electrolyte solution will clear~     Clostridium difficile infection resulting in eradication of Fulminant C. difficile colitis~     (FCDC) while preserving the colon. Furthermore, the investigators hypothesize this will~     reduce morbidity and mortality compared to total abdominal colectomy.~   "
123340|NCT01441258|"~     Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT)~     skills-groups and therapist consultation to treatment as usual successfully reduced symptoms~     of depression. The present study will expand upon these findings. Second, DBT is not known~     for reducing suicidal ideation (SI), a major risk factor for suicide . The present study~     will tailor the aforementioned skills-groups to specifically target suicidal thoughts and~     behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing~     problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study~     will extend this DBT-based approach to a novel population. Fourth, the present study is the~     first DBT intervention to employ state-of-the-art multi-method measurement (including~     objective assessment) of suicidal thoughts and behaviors.~      The investigators hypothesize that participants in the DBT skills (DBT-S) group will show~     improvements in level of suicidality as measured by decreased scores on the Beck Scale for~     Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU)~     group.~   "
123341|NCT01441245|"~     Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion~     and systemic fluid overload. In theory, continuous infusion should allow for a more~     consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the~     neurohormonal activation. This should lead to renal function improvement and BNP decrease.~   "
123342|NCT01441232|"~     This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211~     when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes~     Mellitus.~   "
123343|NCT01441219|"~     Obscure gastrointestinal bleeding (OGIB) has been one of the most challenging area in the~     field of gastroenterology, as small bowel is beyond the reach of ordinary endoscopes like~     oesophagogastroduodenoscopy (OGD) and colonoscopy. Thanks for the latest technological~     advancement for investigating small intestine, we are now capable of obtaining intraluminal~     images safely through capsule endoscopy (CE). Its role in obscure gastrointestinal bleeding,~     Crohn's disease and other small bowel pathologies has already been proven, and nowadays it~     is suggested by various authorities to be the first-line modality among all small bowel~     investigations.~      The investigators group has showed that CE can alter the clinical management of patients~     with OGIB - patients with negative CE has lower rebleeding rate, and therefore we may adopt~     a conservative approach for them. Although supported by some other group as well,~     conflicting results were still reported in the literature about the out-come of these~     patients. The main criticisms for these studies are that, CE can only identify 61% of the~     underlying small bowel bleeding pathology, and one can never ascertain the outcome of~     patients with negative CE examination. Apparently there is still room for improvement in the~     current CE technology.~   "
123344|NCT01441206|"~     The purpose of this study is to learn more about the safety and dosing of rifampin in~     infants.~   "
123345|NCT01441193|"~     This Phase I study was directed at evaluating the safety profile and the immunogenicity of~     the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins~     administered in association in healthy, immunologically competent adults, compared to~     delta-V2 Env or Tat alone.~   "
123346|NCT01441180|"~     Background:~      - GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by~     blocking the hepatitis C virus from dividing in the body. This medication has been used~     along with other medications commonly used to treat hepatitis C, such as interferon and~     ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in~     eliminating the hepatitis C virus from the body. However, interferon can have serious side~     effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin.~      Objectives:~      - To test the safety and effectiveness of GS-7977 alone or given with ribavirin for~     hepatitis C infection.~      Eligibility:~      - Individuals at least 18 years of age who have hepatitis C with liver disease, and have~     never received drugs for it.~      Design:~        -  This study will require multiple clinic visits over 18 months. A liver biopsy will be~          required before the start of the study if participants have not had one within the past~          3 years.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken~          by mouth once a day. Ribavirin is taken by mouth in the morning and evening.~        -  Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will~          involve regular blood tests and symptom monitoring.~        -  After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12,~          16, and 20. Blood and urine tests will be given to study virus levels in the body, and~          symptoms will be discussed.~        -  Participants will stop receiving the study drugs at Week 24.~        -  Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60,~          and 72. Another liver biopsy will be performed at 48 weeks.~        -  Some participants may also be part of a smaller study. This study involves frequent~          blood draws to study drug and virus levels in the blood. The study will require a~          36-hour hospital inpatient visit.~   "
123347|NCT01441167|"~     Background:~        -  Malaria parasites are carried by mosquitoes, which spread the infection by biting~          people. Currently, there is no effective malaria vaccine. However, studies show that~          volunteers bitten many times by mosquitoes that carry weakened malaria parasites could~          fight off getting sick with malaria when later exposed to normal malaria parasites.~          Malaria parasites are weakened by exposing them to radiation when they are in the stage~          of development called sporozoites . Only the mosquitoes are irradiated and study~          volunteers are not exposed to radiation. The radiation stops the parasites from being~          able to cause disease but still promote protection. For many years, it was not possible~          to give these sporozoites to people as a vaccine since they could not be adequately~          purified from the mosquito. Scientists have recently figured out how to produce and~          isolate the weakened sporozoites so that they can be given in an injected vaccine. This~          vaccine is known as the PfSPZ vaccine.~        -  A malaria challenge will be used to test whether the vaccine will prevent infection. In~          a malaria challenge, mosquitoes that have the malaria parasite will be allowed to bite~          a participant's arm. In the event that the vaccine does not work, the malaria parasite~          used for the challenge can be treated completely with common anti-malaria medications.~          Participants will be treated immediately if they develop malaria symptoms.~      Objectives:~      - To test the safety and effectiveness of the PfSPZ vaccine.~      Eligibility:~      - Healthy volunteers between 18 to 45 years of age.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          There will be five different groups of study participants, all of whom will be~          monitored with frequent blood tests.~        -  Group 1 will have two vaccines with the lowest amount of the vaccine given 4 weeks~          apart, with regular clinic visits up to 24 weeks after the second vaccine. This group~          will not have a malaria challenge.~        -  Group 2 will have four or six vaccines given 4 weeks apart at a higher dose than group~          1. A malaria challenge will be given about 3 weeks after the last vaccine. Follow-up~          visits will continue through 24 weeks after the last vaccine.~        -  Group 3 will have four or six vaccines given 4 weeks apart at a higher dose than group~          2. A malaria challenge will be given about 3 weeks after the last vaccination, as for~          Group 2. Follow-up visits will continue through 24 weeks after last vaccine.~        -  Group 4 will have four or six vaccines given 4 weeks apart at a higher dose than group~          3. A malaria challenge will be given about 3 weeks after the last vaccination. Follow~          up visits will continue through 24 weeks after last vaccine.~        -  Group 5 will serve as a control group and will not receive the vaccine, but will have~          the malaria challenge. Follow-up visits will continue through 8 weeks after the~          challenge.~      All participants from any group who receive a malaria challenge will be treated promptly for~     malaria when it develops.~   "
123348|NCT01441154|"~     Background:~      - Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck.~     Thyroid hormone controls the body's metabolism and the function of many organs. The thyroid~     gland produces two forms of thyroid hormone: T4 and T3. People who have thyroid cancer are~     treated with thyroid hormone therapy (synthetic T4, levothyroxine), which at times needs to~     be stopped to allow for cancer treatments. At these times, a different form of thyroid~     hormone (synthetic T3, liothyronine) is used to reduce the symptoms caused by low levels of~     thyroid hormone. Researchers want to know more about how changes in T3 hormone affect the~     body and organ function.~      Objectives:~      - To study how changes in T3 hormone levels affect the body and organ function.~      Eligibility:~      - Individuals at least 18 years of age who have had most or all of their thyroid removed to~     treat thyroid cancer who need to stop taking their regular thyroid hormone dose in~     preparation for the treatment of thyroid cancer.~      Design:~        -  The study involves a screening visit and a baseline evaluation. It also includes an~          11-day inpatient hospital stay.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and a neck ultrasound.~        -  Participants will be evaluated with a physical exam, blood tests, and the following~          procedures:~        -  Glucose tolerance test to measure blood sugar~        -  Tests of body fat, muscle strength, and calorie burning levels~        -  Imaging studies of the heart, liver, and thigh muscles~        -  Quality of life questionnaires~        -  Food preference and diet questionnaires~        -  After 4 weeks of treatment with T3 hormone, participants will have an 11-day inpatient~          hospital stay to study the effect of thyroid hormone on their metabolism. The stay will~          involve the same tests done in the baseline evaluation.~   "
123349|NCT01441141|"~     Background:~      - Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell~     pain are known as crises. High rates of pain crises are associated with a higher risk of~     early death. Some people with sickle cell disease have many severe pain crises while others~     experience fewer crises. This difference in pain crisis may be caused by sensitivity to~     pain. People with high sensitivity to pain may have more pain crises. Many factors,~     including a person's genetic makeup, determine sensitivity to pain. Comparing genetic~     information from people with sickle cell disease and healthy volunteers may provide more~     information on pain and sickle cell disease.~      Objectives:~      - To study genetics and pain sensitivity in sickle cell disease.~      Eligibility:~        -  African or African American individuals at least 18 years of age with sickle cell~          disease.~        -  Healthy African or African American volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          provide blood and urine samples.~        -  Participants will have the following tests:~        -  Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and~          mechanical pain.~        -  EndoPat test to measure blood vessel function and reaction.~        -  Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep~          disturbances.~        -  Measures of daily pain, whether or not related to sickle cell disease.~        -  After the first visit, those in the study will have monthly study visits for 6 months.~          The above tests will be repeated at these visits.~   "
123350|NCT01441128|"~     Background:~      - PF-02341066 and PF-00299804 are drugs that specifically target certain proteins that may~     be more active in cancer cells than normal cells, in particular in non-small cell lung~     cancer. Both drugs seem to be able to stop the growth of or kill cancer cells. Researchers~     want to combine them to see if they are a safe and effective treatment for advanced~     non-small cell lung cancer.~      Objectives:~      - To test the safety and effectiveness of PF-02341066 and PF-00299804 for advanced non-small~     cell lung cancer.~      Eligibility:~      - Individuals at least 18 years of age with advanced non-small cell lung cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and imaging studies. Heart and lung function tests and an~          eye exam may also be given.~        -  The first cycle of treatment will be 28 days. Every cycle after the first will be 21~          days. Participants may have up to 17 cycles of treatment.~        -  Participants will take both study drugs as tablets. Twelve hours after the first dose,~          participants will take only the PF-02341066. This dose schedule will remain the same~          throughout the study.~        -  Participants will be monitored with frequent blood and urine tests and imaging studies.~          Tumor biopsies will be taken as needed. Those in the study will keep a diary to record~          any symptoms or side effects of taking the study drugs.~        -  After 17 cycles of treatment, or after stopping the study drugs early for any other~          reason, participants will have a final followup visit.~   "
123351|NCT01441115|"~     Background:~      - ECI301 is a drug that may help make cancer cells more visible to the immune system after~     radiation. The drug may also help the immune system destroy the cancer at sites that have~     not received radiation therapy. Researchers want to study ECI301 in people with advanced~     cancer or cancer that has spread in the body (metastatic).~      Objectives:~      - To test ECI301 with radiation therapy for advanced or metastatic cancer.~      Eligibility:~      - People at least 18 years of age with either metastatic or advanced cancer that may benefit~     from radiation therapy.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, and imaging studies.~        -  All participants will have radiation therapy 5 days a week for 2 weeks.~        -  They will have different doses of ECI301 to test its safety and effectiveness. ECI301~          will be given in a vein during the second week of radiation therapy. Frequent blood~          tests and imaging studies will monitor the treatment.~        -  After participants have ECI301, tumor samples may be taken from the site that had~          radiation and another site that did not have radiation.~        -  Followup visits will include blood tests and imaging studies....~   "
123352|NCT01441102|"~     Background: Many people with diabetes have macular edema (swelling) at the back of the eye.~     Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in~     the swelling. A drug called dextromethorphan may help prevent the inflammation and the~     swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been~     studied to see if it can help in diabetic macular edema.~      Objectives: To see if dextromethorphan can help treat diabetic macular edema.~      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at~     least one eye.~      Design:~        -  This study lasts 2 years, and will require at least 14 visits to the National Eye~          Institute outpatient clinic. Study visits will be every month for the first 2 months~          and then every other month. Each visit will take about 2 to 4 hours.~        -  Participants will be screened with a physical exam, medical history, eye exam, and~          blood tests. One eye with macular edema will be chosen as the study eye for testing.~        -  Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years.~          A study diary will help keep track of the date, time, and number of pills taken.~        -  Participants will have study visits once a month for the first 2 months and then every~          other month for the rest of the study. Each study visit will involve eye exams and~          blood and urine tests.~        -  Four months after starting the study medication, participants may have laser surgery or~          other treatments for the macular edema, if it is needed.~   "
123353|NCT01441089|"~     Background:~      - Some genes may be associated with a greater chance of side effects during cancer~     treatment. These genes may also make certain treatments less effective. Researchers want to~     collect blood or cheek swab samples from people having cancer treatment to study these~     genes.~      Objectives:~      - To obtain a blood or cheek swab sample to study genetic differences that may affect cancer~     treatment.~      Eligibility:~      - Individuals with cancer who are being treated at the National Cancer Institute.~      Design:~        -  Participants will provide a blood sample for study.~        -  Participants who have blood-based cancer, such as leukemia, will provide a cheek swab~          sample.~        -  If the blood or cheek swab sample does not have enough genetic material for analysis,~          an additional sample may be collected.~   "
123354|NCT01441076|"~     Background:~      - Behcet s disease (BD) is an autoimmune disease where the immune system attacks the body.~     People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most~     drugs used to treat BD suppress the immune system, but they are not always helpful and may~     have side effects. A new drug, anakinra, may be able to treat BD with fewer side effects.~     Because it has not been studied in people with BD, anakinra is considered an experimental~     treatment.~      Objectives:~      - To test whether anakinra can be a safe and effective treatment for Behcet s disease.~      Eligibility:~      - People who have active Behcet's disease, with an oral or genital ulcer within the past~     month, or three or more flares of eye disease in the past 6 months.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests. They will be divided into two groups: those with oral or~          genital ulcers and those with eye disease.~        -  All participants will keep a diary of symptoms for a month before starting the study~          drug.~        -  Participants with oral or genital ulcers will receive daily injections of anakinra for~          3 to 6 months. Treatment will be monitored with frequent blood draws and daily diaries.~          Those who improve but do not have a full response to the drug may receive a higher~          dose. Those who improve after 6 months may have an extra 6 months on either anakinra or~          placebo to study the differences in response.~        -  Participants with eye disease will receive anakinra for up to 12 months. Treatment will~          be monitored with frequent blood draws, daily diaries, and regular eye exams.~        -  All participants will have a final study visit 1 month after stopping the study drug.~   "
123355|NCT01441063|"~     Background:~      - KSHV-associated multicentric Castleman disease (KSHV-MCD) is caused by a herpes virus~     known as KSHV. This disease can also cause several other cancers, including Kaposi sarcoma.~     People with KSHV-MCD often have symptoms like fever, weight and muscle loss, and fluid in~     the legs or abdomen. Tocilizumab may be able to block the chemicals in the body that cause~     KSHV-MCD symptoms. Researchers want to test this drug and other anti-virus drugs to find the~     best combination of drugs to treat KSHV-MCD.~      Objectives:~      - To test the effectiveness of tocilizumab with and without other anti-virus drugs for~     KSHV-MCD.~      Eligibility:~      - People at least 18 years of age who have KSHV-MCD and have certain symptoms and blood~     abnormalities caused by their KSHV-MCD.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests, and a skin biopsy.~        -  Participants will have tocilizumab injections every 2 weeks for up to 12 weeks. They~          will provide daily blood samples for the first 3 days of treatment.~        -  After the sixth dose, participants will be monitored for 4 weeks to check for possible~          side effects.~        -  Those whose KSHV-MCD does not improve or worsens during the study may have tocilizumab~          combined with two other anti-virus drugs, zidovudine and valganciclovir. These drugs~          are pills that will be taken four times a day for 5 days out of every 2 weeks.~        -  Blood, urine, and saliva samples will be collected throughout the study.~   "
123362|NCT01440959|"~     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib~     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients~     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib~     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure~     with imatinib. However, virtually all patients will eventually progress or become~     intolerable after the first-line imatinib and the second-line sunitinib. Dovitinib (TKI258,~     Novartis) is a multi-kinase inhibitor. TKI258 is a potent inhibitor of the VEGFR 1, 2, and~     3, FGFR1, 2 and 3, PDGFRβ, Kit, RET, TrkA, CSF 1R, and FLT3 with inhibitory concentration~     50% (IC50s) of less than 40nM. Stem cell factor (SCF) also termed KIT ligand, or steel~     factor has been shown to modulate tumor angiogenesis. In cultured human endothelial cells~     and Kit expressing cancer cells, TKI258 inhibits VEGF- and SCF-stimulated mitogenesis. .~   "
123363|NCT01440946|"~     The primary objective of the study is to evaluate the safety of Recombinant Human~     Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects~     with hemophilia B. Secondary objectives of this study in this study population are as~     follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding~     episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc~     consumption for prevention and treatment of bleeding episodes~   "
123356|NCT01441037|"~     Background:~      - Some people have bone marrow and lung disorders that are caused by genetic problems. These~     problems often involve damage to the ends of the chromosomes that pass down genes. One of~     these disorders is aplastic anemia. This is a disorder in which the bone marrow does not~     make enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to~     improve bone marrow function and treat aplastic anemia. More information is needed on~     whether Danazol can help repair the damaged chromosomes that cause aplastic anemia and~     similar disorders that cause low blood cell counts or lung problems.~      Objectives:~      - To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused~     by damaged genes.~      Eligibility:~      - Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused~     by damaged genes.~      Design:~        -  Participants will be screened with a physical exam and medical history. Then they will~          have blood and urine tests, imaging studies, and a lung function test. They will also~          take a 6-minute walking test and have a bone marrow biopsy.~        -  Participants will receive Danazol to take twice a day for the duration of the study.~        -  Participants will have regular study visits at 6, 12, and 24 months, with blood tests,~          imaging studies, a lung function test, and a 6-minute walking test. A bone marrow~          sample will be collected at the 12-month visit.~        -  Participants will remain on the study for up to 2 years. Researchers will follow up~          with them for 2 years after the end of the study.~   "
123357|NCT01441024|"~     Background:~      - Parainfluenza is a virus that can cause infections in people. Most people infected with~     this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common~     cold). Some people, especially those with a weakened immune system, get very sick from this~     virus. They may have difficulty breathing or develop lung infections. Currently, there are~     no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus~     go away faster. Researchers are interested in testing DAS181 to see if it is safe and~     effective against parainfluenza.~      Objectives:~      - To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.~      Eligibility:~      - Individuals at least 18 years of age who have the parainfluenza virus and have developed~     symptoms within the past 10 days.~      Design:~        -  Participants will be screened with a physical exam, medical history, and questions~          about symptoms and activity levels. Participants will also have a lung function test~          and provide blood and nasal fluid samples.~        -  DAS181 is an inhaled medication, and everyone will receive a study medication inhaler.~          Participants will receive either DAS181 or a placebo through the inhaler. They will~          take it once every day for 5 days.~        -  Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide~          blood and nasal fluid samples and have a lung function test.~        -  Participants who still have the virus in their system on Day 28 will return to the~          clinic on Day 42 for more tests. Participants who still have the virus in their system~          on Day 42 will return to the clinic on Day 56 for more tests.~        -  Participants will have followup visits 6 months and 1 year after the start of the~          study....~   "
123358|NCT01441011|"~     Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of~     recurrence and death compared to their normal weight counterparts. Moreover, weight gain and~     decreased physical activity are common after diagnosis and also increase the likelihood of~     breast cancer recurrence and death. Rural women suffer from health disparities in breast~     cancer diagnosis and treatment. Women of the most rural counties also have the highest~     prevalence of obesity compared to urban women. To address these disparities, the overarching~     objective of this proposal is to develop a clinically effective and cost efficient strategy~     for delivering a weight control intervention to rural breast cancer survivors. Group~     phone-based treatment via conference call is a novel treatment delivery approach that the~     investigators have shown to be effective for initial weight loss among rural breast cancer~     survivors and more effective than the standard individual phone-based approach among rural~     women. This innovative method of providing group treatment addresses access barriers in~     rural areas and may be especially ideal for rural breast cancer survivors because it~     provides social support in conjunction with a level of anonymity. However, the impact of~     group phone counseling during extended care for weight loss maintenance beyond 6 months~     remains unknown. Weight loss maintenance is the more challenging phase of treatment when~     weight regain is common, and this regain presents a potential risk for breast cancer~     recurrence. This randomized controlled trial will evaluate the effects of group phone-based~     treatment for weight loss maintenance among rural breast cancer survivors, compared to an~     established mail-based education comparison condition, subsequent to a 6 month group~     phone-based weight loss phase for both conditions. In addition to the intervention impact on~     weight loss maintenance, the study will provide estimates of incremental cost-effectiveness~     per kg loss between the two conditions and the impact on secondary outcomes including~     quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.~   "
123359|NCT01440998|"~     This pilot clinical trial studies how well dasatinib works together with paclitaxel and~     carboplatin in treating patients with stage III, stage IV or endometrial cancer that has~     come back after a period of improvement. Dasatinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving dasatinib together with paclitaxel and carboplatin may kill more tumor cells.~   "
123360|NCT01440985|"~     Participants will be smokers who want to quit, and have visible nicotine stains on their~     teeth. They will be given toothpaste and a toothbrush to use during the study, and will have~     an equal chance of being assigned to use either a nicotine gum or microtab. They will visit~     the study site five times during the 12 week trial to have their teeth examined.~   "
123361|NCT01440972|"~     The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance~     training program with concurrent application of partial blood flow restriction (PBFR) to the~     exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in~     women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be~     change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators~     will test the following hypotheses. In comparison with low-intensity resistance training~     without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:~      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee~     extensor strength~      Secondary Hypotheses:~        1. Increase quadriceps muscle volume assessed by MRI~        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed~          stair climb~        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and~          Osteoarthritis Outcome Score (KOOS) questionnaire~   "
123376|NCT01440777|"~     This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep)~     which provides a set of various psycho-educational materials and behavioral techniques to~     reduce insomnia symptoms, improve sleep, and improve quality of life.~   "
123364|NCT01440933|"~     Sugammadex is a new reversal agent for neuromuscular blockers (curare). It encapsulates the~     curare molecule and terminates immediately its action. The recommended dose is 2 mg/kg for a~     slight neuromuscular block and 4 mg/kg for a profound neuromuscular block. Magnesium~     sulphate is frequently used in perioperative medicine and it is known to reinforce the~     neuromuscular block induced for instance by rocuronium. The researchers want to investigate,~     whether higher doses of sugammadex must be given to antagonize the neuromuscular block~     induced by rocuronium in patients who received magnesium sulphate.~   "
123365|NCT01440920|"~     The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with~     acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who~     completed a standard consolidation therapy.~   "
123366|NCT01440907|"~     The purpose of this research study is to evaluate the effect of a health information~     exchange (HIE)-supported care coordination package on 30-day readmission rates in a frail~     elderly population.~   "
123367|NCT01440894|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012,~          BF-1039, BF-1041-A, and GBF-950-D.~        4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).~        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.~   "
123368|NCT01440881|"~     This project evaluates whether nesiritide, human recombinant brain natriuretic peptide,~     confers renal protection during cardiovascular surgery by attenuating the inflammatory~     response.~   "
123369|NCT01440868|"~     BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the~     efficacy of the respiratory effort in lung of preterm infants at risk for respiratory~     distress syndrome (RDS) and reduce need of mechanical ventilation (MV).~      The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in~     the delivery room protocol may reduce the need of MV in preterm infants.~      STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried~     out at the neonatal care units of the Careggi Infants with a gestational age between 25 and~     28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation~     pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive~     end expiratory pressure (PEEP) of 5 cm H2O.~      Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the~     transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size:~     hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of~     life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each~     groups to detect this difference statistically significant with 80% power at 0.05 level.~   "
123370|NCT01440855|"~     This study was designed to provide a preliminary evaluation of the efficacy and usability of~     the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment,~     (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward~     provides early stage cancer patients during the period after completing active treatment~     practical ways of dealing with common problems, including guidelines for managing physical,~     social, and emotional health. Assessments were completed at the patient's final cancer~     treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial~     assessments covered background information (demographics, medical status), use of~     educational materials, survivorship activities, and psychological factors. The follow-up~     assessments included use of actions recommended in Facing Forward, ratings of Facing Forward~     with respect the booklet's informativeness, helpfulness, understandability, and extent read,~     the same psychological measures used initially, and a measure of self-efficacy.~   "
123371|NCT01440842|"~     The purpose of this study is to assess the efficacy, safety and feasibility of a~     computer-based control algorithm to control glucose levels in adults in intensive care unit,~     in comparison to standard care.~   "
123372|NCT01440829|"~     The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on~     plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt~     (TIPS) procedure.~   "
123373|NCT01440816|"~     This phase II trial studies how well giving interleukin-12 gene and in vivo~     electroporation-mediated plasmid DNA vaccine therapy works in treating patients with Merkel~     cell cancer. Placing the gene for interleukin-12 into Merkel cells may help the body build~     an effective defense to kill tumor cells~   "
123374|NCT01440803|"~     Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise~     completely healthy individuals with no secondary cause of bone loss. In the course of our~     prior research with premenopausal women with IOP, the investigators have shown that women~     with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared~     to normal women. Additionally, using noninvasive high resolution imaging of the central and~     peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the~     investigators identified several features of bone quality in premenopausal women with IOP.~      There is currently no FDA-approved therapy for IOP in premenopausal women. However,~     teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in~     postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as~     well as men, premenopausal and postmenopausal women with glucocorticoid-induced~     osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated~     prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to~     support development of therapies for this indication. Therefore, the major objective of this~     protocol is to establish the safety and efficacy of teriparatide in premenopausal women with~     IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the~     study, but a randomly selected group of patients (10) will receive one year of placebo~     injections first before starting their two years of treatment. The remainder of subjects~     (30) will receive active drug only for two years.~      Funding Source - FDA OOPD~   "
123375|NCT01440790|"~     The objective of this study is to determine the effect of reducing the rate of glucose~     absorption on oxidative stress after eating and to compare it with the effects of vitamin C.~     The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress~     to a similar extent as 1g vitamin C.~   "
123379|NCT01440738|"~     Objectives~      Main objective: Assessing the effectiveness of the health workshops, in terms of quality of~     life.~      Secondary: To determine the effectiveness of the health workshops in relation to: Increase~     knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced~     diet. Incorporate and maintain regular physical activity; Keep variables related to risk~     factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To~     estimate costs.~      Methodology~      Design: randomized controlled trial comparing a group of patients who performed the health~     workshops with a control group with similar characteristics.~      Scope of the Study: The study was conducted in 54 health centers of Barcelona city.~      Subjects of study: general population between 18 and 65 years who consent to. 188 people~     with speech (have conducted workshops for health) and 188 people without (not made health~     workshops. Data Analysis: T- test to compare the differences between quantitative variables~     or equivalent non-parametric if the distribution of the variable does not meet criteria of~     normality (Kolmogorov-Smirnov).~   "
123380|NCT01440725|"~     This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised~     clinical trial in patient with muscle rupture and with hematoma production. The main~     hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich~     plasma (PRP)improves muscle regeneration and repair by shortening the time to complete~     recovery.~      The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or~     distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion~     recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's~     safety.~      Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique~     dose) by muscular infiltration en the empty space generated after the hematoma evacuation.~     Control treatment will be hematoma evacuation. Both treatment groups will use compressive~     bandage and they will recommend rest, extremity elevation, local ice and lately~     physiotherapy.~      Size sample: 76 patients (38 in each group)~   "
123381|NCT01440712|"~     The purpose of this trial is to determine whether the water-soluble contrast (gastrografin)~     is more effective in the treatment of postoperative ileus than the conventional one.~   "
123382|NCT01440699|"~     Adipose-derived stem cells have properties of differentiation to various types of cells,~     immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.~      Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in~     Phase I and II study on the patients with Crohn's fistula.~      However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing~     ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and~     efficacy in patients with Crohn's fistula.~   "
123383|NCT01440686|"~     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics~     of HL-032 after oral administration in healthy male volunteers.~   "
123384|NCT01440673|"~     -  Gynecological surgery is associated with a high incidence of postoperative nausea and~          vomiting.~        -  NK1 receptor antagonists such as aprepitant appear to be highly effective for treating~          acute and delayed emesis, and yet understanding of the efficacy of different doses of~          aprepitant is limited.~        -  We performed a prospective, randomized, double-blinded placebo-controlled study of 123~          female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant,~          125 mg aprepitant, or a placebo.~   "
123385|NCT01440660|"~     To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression~     using multimodal testing/imaging procedures.~   "
123386|NCT01440647|"~     Very premature infants often cannot breathe on their own and require assistance with a~     respirator. Conventional respirators deliver air or oxygen via a breathing tube placed~     through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube~     is associated with injury to the lungs. Currently, a premature baby has to be ventilated~     through an endotracheal tube until he/she can fully breathe independently. In the current~     study, in order to shorten the time with an endotracheal tube, we utilized an alternative,~     less invasive ventilation procedure, nasal intermittent positive pressure ventilation~     (NIPPV). This procedure provides help with breathing, but requires only nasal, not~     endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage~     in their recovery, when they could not breathe independently yet. Thus, by switching babies~     at this early stage from a regular respirator to NIPPV, we should be able to shorten the use~     of an injurious endotracheal tube.~   "
123387|NCT01440634|"~     Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results~     from progressive atherosclerosis of arteries in the lower extremities. PAD is also~     associated with major detrimental effects on quality of life and functional status, and is~     the most important cause of limb amputation. More importantly, PAD is a major manifestation~     of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.~     Despite its frequent occurrence, little is known about the natural history of PAD in~     Hispanics who represent 12.5% of the United States. Because access to health care is limited~     among Hispanics, CBPR is the ideal process to reach this target population. The goal of the~     proposed study is to evaluate community-based strategies of detection and treatment of~     peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases:~     a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD~     detection study , the prevalence and severity of PAD in this population will be determined.~     Specific risk factors associated with PAD among the Hispanic participants will be~     identified. During the second phase patients will be enrolled in a randomized, non-blinded~     trial comparing a community-based risk factor modification and supervised exercise program~     versus usual care for PAD. These individuals will undergo a baseline evaluation similar to~     the one obtained during the first phase of the study, but will also include functional~     testing of the lower extremities.~   "
123414|NCT01440283|"~     High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve~     cells of the body. It mostly affects infants, and more children die from this tumor each~     year than are cured. Standard therapy includes a combination of chemotherapy, surgery, bone~     marrow transplant, radiation and immunotherapy. NB is very sensitive to radiation, but due~     to it's aggressive spread pattern, radiation use is currently limited by toxicity. This~     study seeks to improve delivery of radiation to reduce toxicity by quantifying outcomes, and~     measuring differences in renal toxicity and organ motion so that radiation can be focused~     more effectively against tumor while sparing normal tissues and reducing side-effects.~   "
123388|NCT01440621|"~     Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among~     patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in~     itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue~     which persists even after rest and has significant effects on quality of life.~      The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with~     almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.~      Given that fatigue can affect treatment adherence by patients, it is important to initiate~     measures to either prevent or mitigate Cancer Related Fatigue.~      The investigators intend to use modafinil in cancer related fatigue, in view of the fact~     that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and~     fibromyalgia. In addition, there have been a few small trials which have hinted towards~     benefit with the use of modafinil in cancer related fatigue.~      The investigators have chosen a dose of 100mg/day in the morning, to be compared with~     placebo. The study arm and the placebo arm will be stratified with respect to age, sex,~     disease site, baseline performance status.~      Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue~     Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance~     status, changes in systolic and diastolic blood pressure, and changes in weight.~   "
123389|NCT01440608|"~     The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc~     therapy and de-worming albendazole as separate interventions in restoring normal gut~     absorptive and immunological function as measured by the dual sugar permeability test and~     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental~     Enteropathy.~   "
123390|NCT01440595|"~     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir~     (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and~     ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3~     (GT3) hepatitis C virus (HCV) infections.~   "
123391|NCT01440582|"~     The goal of this clinical research study is to find the highest tolerable dose of the drug~     panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid~     (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug~     combination will also be studied.~      Panobinostat is designed to cause chemical changes in different groups of proteins that are~     attached to DNA (the genetic material of cells), which may slow the growth of cancer cells~     or cause the cancer cells to die.~      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer~     cells to die.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may slow the growth~     of cancer cells.~      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.~     Dexamethasone is often given to MM patients in combination with other chemotherapy to treat~     cancer.~   "
123392|NCT01440569|"~     This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus~     two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected,~     antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV)~     resistance-associated mutations.~      After the Week 48 Visit, participants will be given the option to participate in an~     open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it~     becomes commercially available, or until Gilead Sciences elects to terminate development of~     cobicistat.~   "
123393|NCT01440556|"~     Autologous hematopoietic cell transplantation is currently considered the standard therapy~     of multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in~     transplant procedures and supportive care, allogeneic bone marrow transplantation is less~     commonly used due to high transplant related mortality (TRM).~      No consensus statement about allografting in MM has so far been reached and only a minority~     of patients undergoing allografting are enrolled in prospective clinical trials.~      Moreover, use of unrelated donors is considerably increased over the time and the recent~     activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that~     the number of allografts from unrelated donor is higher than that one from HLA-identical~     siblings in Europe.~      In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients,~     the investigators plan to conduct a restrospective study through the Italian Bone Marrow~     Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be~     collected from the central data management system Promise (Project Manager Internet Server)~     used by EBMT and from IBMDR.~      The aim of the study is to evaluate the role of unrelated donor allograft in multiple~     myeloma over the last decade and hopefully offer recommendations on patient selection.~     Primary endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the~     allograft b) Event-Free-Survival (EFS) from the allograft. Disease response criteria will be~     defined according to the International Uniform Response Criteria for multiple myeloma.~     Transplant related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic~     (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate~     analysis will be calculated for the transplant-related and patient-related characteristics.~   "
123394|NCT01440543|"~     Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as~     alternative colonoscopy techniques have been documented to decrease patient discomfort~     during and after the procedure.~      This prospective, randomized, single-center trial was designed to evaluate whether the~     combination of water immersion during insertion and CO2 insufflation during withdrawal~     (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other~     colonoscopy methods (Water/Air, CO2/CO2, Air/Air).~   "
123395|NCT01440530|"~     The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in~     Primary Care is to compare usual care to an online, multi-media, digital intervention for~     Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.~   "
123396|NCT01440517|"~     The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in~     diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart~     Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and~     imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic~     dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with~     99mTc-maraciclatide.~   "
123397|NCT01440504|"~     The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 +~     association platinum in samples exposed and demonstrate the value of this combination~     compared to the agents used alone.~   "
123564|NCT01438333|"~     The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus~     brevis CD2 tablets in addition to the primary treatment for patients with chronic~     periodontitis (Full Mouth Disinfection), at local level and at systemic level.~   "
123565|NCT01438320|"~     The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid,~     is safe and has antiviral activity in people with hepatitis C.~   "
123398|NCT01440491|"~     The aim of this study was to evaluate the effect of exercises performed under monitoring of~     the physiotherapist and self performed at home by reading the booklet of exercise~     orientation for patients with nonspecific low back pain.~      A prospective and randomized trial was performed in 44 patients. G1 patients received a~     physiotherapist orientation, and G2 patients received the booklet of exercise to self~     perform the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by~     SF-36 were measured before.~      Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was~     better in G1.~      The exercises under orientations of the physiotherapist promoted best effect than self~     performed exercises .~   "
123399|NCT01440478|"~     This study is designed to explore the effect of increased and decreased urinary pH on the~     single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All~     participants will receive the three treatments in a randomized order.~   "
123400|NCT01440465|"~     The objective of this study was to evaluate the various parameters involved in the~     occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or~     hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics~     protocols.~   "
123401|NCT01440452|"~     This research is being done to see how different amounts of Functional Electrical~     Stimulation (FES) affect cycling on factors in blood and spinal cord in people with spinal~     cord inflammation.~   "
123402|NCT01440439|"~     Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes~     like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes~     are treated with a basal bolus insulin regimen, with background insulin provided by~     long-acting basal insulin doses, and bolus doses of short-acting insulin used to~     accompany food intake. Evidence shows that the main factor preventing people with diabetes~     from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A~     previous study has shown that the type of background insulin affects the likelihood of an~     individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards.~     The aim of this study is to examine this further.~      The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will~     be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with~     insulin glargine than insulin detemir. Exercise intensity can have an influence on the~     likelihood of hypoglycaemia, and in this previous study exercise intensity was measured~     using heart rate. This study will use a more formal definition of exercise intensity. The~     investigators will study blood glucose during exercise, but also metabolism as measured by~     hormones affecting blood glucose levels as well as markers of fat metabolism. The~     investigators will also use a continuous glucose monitoring system (CGMS) to consider~     hypoglycaemia on thei night following exercise as this is a recognised consequence of~     exercise in type 1 diabetes.~      The null hypothesis to be tested in this study is that there is no difference between the~     two insulins in their effect on blood glucose levels and metabolism during exercise and~     rates of nocturnal hypoglycaemia after exercise.~   "
123403|NCT01440426|"~     This study deals with coverage of multiple denuded roots. The current standard treatment~     requires surgical correction and uses soft tissue taken from the roof of the mouth to~     enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called~     Mucograft) can be used to replace soft tissue taken from the subject. If the collagen matrix~     will prove to be equally as effective as the patient own tissue, it will be possible to~     avoid a more extensive surgery and decrease pain and discomfort.~   "
123404|NCT01440413|"~     This is a prospective, non-randomized study which aims to evaluate the response to a~     neoadjuvant chemotherapy according to the the antitumor immune response in localized breast~     cancer.~      40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4~     anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.~      Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated~     and receive an adjuvant treatment which will both depend on the investigator's appreciation.~      Blood sample will be collected on the first day of the first chemotherapy cycle, on the~     first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.~      Tumor sample will be collected on diagnosis as much as possible and on surgery.~      Patients will be followed during 5 years.~   "
123405|NCT01440400|"~     The classical method for spinal anesthesia relies on the use of bony landmarks to identify~     the level and point of entry of the spinal needle. Over the years, in experienced hands,~     this method consistently proved to be successful and safe.~      The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was~     relatively slow compared to peripheral nerve blocks or central venous catheterization. This~     could be due to the technical difficulties posed by the bony structures surrounding the~     spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are~     reluctant to change their conventional landmark technique, particularly with most studies~     showing no change in the success rate between ultrasound guided and the landmark techniques.~      Several studies however showed that the ultrasound guided approach reduces the number of~     attempts to achieve a successful block and reduces the procedure time particularly in obese~     patients and those with technical difficulties.~      In this study the investigators are trying to answer the following question : Is there any~     advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients~     with easily palpable bony landmarks?~   "
123406|NCT01440387|"~     The purpose of this study is to evaluate the immunogenicity and the safety of~     GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza~     vaccine FLU-Q-QIV in adults 18 years of age and older.~   "
123415|NCT01440270|"~     Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in~     head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody~     results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell~     proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases.~     The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and~     radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on~     prognosis. The endpoints of this study are the pathological complete response after~     neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival~     rate, and the safety.~   "
123407|NCT01440374|"~     This is a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part~     3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with~     myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia~     due to bone marrow insufficiency from their underlying disease or prior chemotherapy. This~     objective will be assessed by a composite primary endpoint that consists of the following:~     the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or~     platelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone~     marrow insufficiency from their underlying disease or prior chemotherapy will be enrolled in~     the study. No low or intermediate-1 risk MDS subjects will be enrolled in the study.~      Subjects must have had at least one of the following during the 4 weeks prior to enrolment:~     platelet count <10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportive~     standard of care (SOC), including hydroxyurea, will be allowed as indicated by local~     practice throughout the study. The study will have 3 sequential parts. Subjects who are~     enrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized,~     double-blind); however, subjects who complete the treatment period for Part 1 or Part 2 (8~     and 12 weeks, respectively) will continue in Part 3 (extension) if the investigator~     determines that the subject is receiving clinical benefit on treatment.~   "
123408|NCT01440361|"~     Chronic immune thrombocytopenia (ITP) is a longterm disease in which the blood does not clot~     normally. This is due to a low number of blood cell fragments called platelets. Platelets~     clot to seal small cuts or breaks on blood vessel walls and stop bleeding. Normally the~     immune system makes proteins called antibodies to fight off harmful substances that enter~     the body. In ITP, the immune system produces antibodies that attack and destroy the body's~     platelets by mistake.~      Patients can suffer from bleeding under the skin, nosebleeds, blood in urine or stools and~     in very severe cases bleeding in the brain. Patients have an increased frequency of death~     from bleeding complications compared to normal.~      Chronic ITP is fairly rare , with an incidence of 32 new cases/million people each year.~      Existing treatments work by lowering the activity of the immune system or directly~     increasing platelet count. These treatments do not work effectively in all patients and can~     have side effects. We hope that understanding how belimumab works in ITP will help in the~     development of future treatments for ITP and other autoimmune diseases.~      We will test the safety, blood levels and effects of the study medication in people with~     chronic ITP. Patients will receive the study medication intravenously (through a needle~     inserted into a vein) and blood samples will be taken before and on several occasions~     afterwards.~      Up to 40 patients with chronic ITP, aged 18 to 75 will participate. Approximately 11~     patients will take dummy medicine instead of the study medicine neither they or their study~     doctor will know which one they are given. Participants will take up to 57 weeks to finish~     the study. They'll make 12 outpatient visits.~      The study will take place in hospitals in the UK. Other sites in mainland Europe may also be~     initiated.~      A pharmaceutical company, GlaxoSmithKline, is funding the study.~   "
123409|NCT01440348|"~     This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a~     single free tendon Achilles allograft using new technique.~   "
123410|NCT01440335|"~     Background:~      - Fenoterol has been used to treat asthma by opening up the airways in the lungs. It also~     increases the heart rate without significantly increasing blood pressure. This means that it~     may help improve heart function by boosting the heart's output. Researchers have developed a~     different form of the drug that may be given to individuals with heart trouble. This new~     form needs more testing. It is especially important to compare the new form with the~     original form of the drug used to treat asthma.~      Objectives:~      - To compare how safe and effective two different forms of Fenoterol are in improving heart~     function.~      Eligibility:~      - Healthy people between 21 and 60 years of age who have no history of heart disease.~      Design:~        -  People will be screened with a medical history, physical exam, blood and urine tests,~          and heart function studies.~        -  Those in the study will have two 36-hour inpatient study visits. At each visit, they~          will have a physical exam and blood and urine tests. They will fast overnight and then~          receive one of the two forms of Fenoterol first thing in the morning. They will not~          know whether they are getting the original or the modified form of the drug. After~          receiving the drug, they will provide frequent blood and urine samples for 24 hours.~          They will have a final exam before being discharged.~        -  Those who take part in the study will have a followup visit 5 to 7 days after the end~          of each study visit. They will provide more blood and urine samples and have a physical~          exam.~   "
123411|NCT01440322|"~     The purpose of this study was to evaluate the subjective and objective performance and the~     physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX®~     AQUA contact lenses in participants with normal eyes and prescription needs.~   "
123412|NCT01440309|"~     The study is designed to evaluate the safety and efficacy of intravenous administration of~     bone marrow derived mesenchymal stem cells for patients with refractory primary biliary~     cirrhosis (PBC).~   "
123413|NCT01440296|"~     The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded~     through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes~     of Health Research (CIHR). This unique research network is focused on the pathobiology of~     atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN~     research program involves the creation of a unique national network focused on in vivo~     imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as~     the acquisition of clinical and pathological end points. CAIN enables unprecedented~     cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease~     in coronary or carotid vascular beds, and has established an international resource for~     studying the natural history, progression, regression and novel therapeutic interventions~     aimed at atherosclerosis.~      The primary outcome of this study is to accurately characterise carotid plaque morphology in~     non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will~     also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the~     brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years~     or sooner if presenting clinically in order to monitor the natural history of carotid~     atherosclerosis and its effect on end-organ brain disease.~      Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of~     clinical and imaging data. After each imaging session images will be processed, stored~     locally and also sent to a central repository. 500 patients will be recruited over a 2 year~     period in anticipation of study completion within 4 years.~   "
123416|NCT01440257|"~     The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary~     albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to~     study the safety and efficacy of the medication in this patient population.~   "
123417|NCT01440244|"~     Although thoracic NOTES may not be ready for human trials, a new minimally invasive~     technique to access the pleural cavity and perform pleural, pulmonary and mediastinal~     procedures would be possible. Cervical Video Assisted Thoracoscopic Surgery (C-VATS) is a~     technique that borrows from traditional VATS procedures, from cervical mediastinoscopy, and~     from flexible endoscopy. All of these procedures are very familiar to the thoracic surgeon.~      The current feasibility and safety study examines C-VATS as a method of evaluating,~     biopsying and performing pleurodesis in patients with pleural disease and or effusion.~   "
123418|NCT01440231|"~     Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune~     system attacks its own organs and tissues. Within the immune system, B-cells and plasma~     cells make proteins called antibodies, which in autoimmune disease can bind to one's own~     tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body,~     called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells,~     and thus the production of antibodies. This study will assess whether treatment with~     atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning~     that it is not available outside of a clinical trial, and that its potential benefits and~     risks have not been fully determined.~      A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a~     1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg,~     atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.~      The primary objective of the trial is to evaluate the efficacy of atacicept compared to~     placebo in reducing SLE disease activity in subjects treated with standard of care (SoC)~     therapy and to investigate the dose-response relationship.~      The secondary objectives of the trial are:~        -  To evaluate the effect of atacicept in reducing corticosteroid usage~        -  To evaluate the safety and tolerability profile of atacicept in subjects with SLE~        -  To confirm the PK and PD profiles of atacicept in SLE subjects~        -  To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey~          [SF-36].~   "
123419|NCT01440218|"~     This research is being done to learn more about possible genetic causes of currently~     undiagnosed conditions, and to find out how the development of new technologies, such as DNA~     sequencing, can increase knowledge of the role genetic variants play in disorders and~     possibly how genetic variants may help de-termine the best treatment options.~      The recent development of new technologies has increased our ability to understand how~     genetic mutations are associated with disease. Using these technologies to find the genetic~     variants responsible for rare diseases is a rapidly growing field and has already begun to~     transform the way conditions with unknown causes are diagnosed and treated.~      Hypothesis: Identification of new genomic variants associated with idiopathic diseases~     and/or diseases of unknown etiology will advance medical knowledge about rare and common~     diseases.~   "
123420|NCT01440205|"~     The mailer will encourage all employees of one of Evive's partner companies to attend an~     on-site free flu shot clinic they are offering in the fall of 2011. The research will~     examine differences in follow-through on getting a flu shot at an on-site clinic among the~     targeted population during the ~1 month period when clinics are being offered (following the~     mailing) as a function of experimental condition.~   "
123421|NCT01440192|"~     The primary objective of the study is to assess the safety and tolerability of a single dose~     of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are~     refractory to one or more of the following treatments for PS:~     methotrexate,immunosuppressants or cytotoxic agents.~   "
123422|NCT01440179|"~     Primary Objective:~      Participants achieving an Objective Response Rate~      Secondary Objectives:~        -  Response duration~        -  Progression Free Survival~        -  Minimal residual disease~        -  Safety~        -  Pharmacokinetics~   "
123423|NCT01440166|"~     -  To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative~          to placebo in healthy adult volunteers.~        -  To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy~          adult volunteers.~        -  To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult~          volunteers.~   "
123424|NCT01440153|"~     Professional dancing requires an almost perfect control of technical skills, combined with a~     good physical condition. To meet the demands of choreography, dancers need an adequate~     aerobic endurance capacity, muscular strength as well as flexibility and motor control~     (Twitchett et al. 2009; Roussel et al. 2009). One could compare these requirements to those~     of an athlete. In contrasts to athletes, only few attention has been given to the prevention~     of injuries in dancers. Professional dancers are at high risk to develop musculoskeletal~     injuries, especially, soft tissue and overuse injuries to lower extremities and~     spine(Hincapié et al, 2008). Several potential risk factors for injury have been suggested,~     such as a reduced level of aerobic fitness, lack of muscular strength, hypermobility of the~     joints and altered motor control of the lumbopelvic region but no conclusive evidence exists~     for any of these items separately.~      Applying sports science principles to dance training may improve the performances of the~     dancers (Twitchett et al. 2009). Dancers demonstrate low aerobic fitness and muscle~     strength, in contrast to the high demands. Aerobic endurance of dancers is for example~     comparable to healthy adults with a sedentary life style.~      Fitness programs, additional to regular dance classes, have only recently been considered~     (Twitchett et al. 2009). The advantages of additional training in athletes is beyond~     questioning. Nevertheless, this concept is relatively new for dancers. On the one hand,~     professional dancers do not consider themselves as a sportsmen but as artists (Wyon et al,~     2007). On the other hand, choreographers and dancers fear the negative influence of training~     on body aesthetics.~      Additional fitness training could improve physical fitness & motor control and may help with~     stress coping during public performances. Therefore, the purpose of this randomized~     controlled trial is to examine whether an additional intervention to regular dance lessons~     influences the physical condition and musculoskeletal injury rate in professional dancers.~   "
123425|NCT01440140|"~     The main study objective is to compare real-time continuous subcutaneous glucose monitoring~     (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone~     in the home setting.~   "
123426|NCT01440127|"~     Metformin is drug that is normally used to treat people with diabetes. New research has~     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up~     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or~     for causing recurrence of the cancer. The purpose of this study is to determine the effect~     of metformin on colorectal cancer tumors. The study is designed to develop the methods to~     test tumors for cancer stem cells and then to determine the difference between treating with~     metformin and not treating with metformin with regard to the cancer stem cells. This~     research is investigational because the effect of metformin on cancer stem cells is not~     known in humans. Also, in patients who are not diabetic, metformin would normally not be~     given prior to surgery.~   "
123427|NCT01440114|"~     The propose of this study is to determine the effect of intravenous fentanyl prior the end~     of surgery on the incidence and severity of EA in pediatric patient.~   "
123428|NCT01440101|"~     The primary objective of Part A is to determine the safety and tolerability of natalizumab~     administered over 24 weeks in Japanese participants with relapsing-remitting multiple~     sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs),~     changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS)~     scores, and changes in physical and neurological examination findings. The secondary~     objectives of Part A are to characterize the pharmacokinetics (PK) profile and~     pharmacodynamics (PD) of natalizumab.~      The primary objective of Part B is to determine if natalizumab, when compared to placebo, is~     effective in treating Japanese participants with relapsing-remitting MS, as measured by new~     active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active~     lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging~     T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development~     of new active lesions over 24 weeks.~      Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when~     compared to placebo, is effective in reducing the frequency of clinical exacerbations,~     reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging~     T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free~     participants, and improving outcomes on visual analog scale (VAS) assessing the~     participant's global impression of his/her well-being. Additional objectives are to assess~     the safety and tolerability, the incidence of serum antibodies to natalizumab and the PK~     profile of natalizumab.~   "
123429|NCT01440088|"~     The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is~     safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft~     Tissue Sarcoma.~   "
123430|NCT01440075|"~     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.~      It has been reported worldwide, but it is ten times more common in Asian population. The~     annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the~     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80%~     of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~      It may results in acquired heart disease in children in developed countries, and may be the~     cause of premature coronary artery disease in adulthood.~      A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S~     population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are~     conflicting on this issue and the prevalence of this allel is unknown in North America and~     Europe populations.~      The clinical picture of KD associate a persistent fever and an antipyretics resistance with~     mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is~     confirmed by the presence of five clinical signs (major criteria). The presence of~     inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.~      KD can resolve spontaneously with no treatment. The severity of the disease is primarily~     related to complications of coronary aneurysms in acute or chronic stages.~      Several arguments support the fact that adult patients have diffuse vascular lesions~     different from aneurysmal lesions initially described in childhood.~      Despite abundance of publications on KD, there is no prospective or retrospective study~     which explored anomalies resulting from KD in adult subjects.~      Therefore, this project will describe the patient's vascular evolution, the prevalence of~     atherosclerotic lesions and to determine the biological and functional abnormalities,~     markers of accelerated atherosclerosis.~      Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in~     adulthood.~      The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent~     and their severity in adults with a history of KD in childhood compared to a control~     population.~   "
123431|NCT01440062|"~     Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple~     Sclerosis (MS).~   "
123432|NCT01440049|"~     On a population of patients followed by an office-based cardiologist and treated with~     eplerenone, the objectives of the survey are:~        -  To describe the characteristics of the population treated.~        -  To describe the methods of use of eplerenone (posology, duration of treatment,~          medicinal combinations).~        -  To describe the follow-up methods of the treatment.~        -  To describe the possible interruptions of the treatment~   "
123433|NCT01440036|"~     The objective of the research, is to examine the hypothesis, that the enzyme paraoxygenase 1~     ( PON1) can influence carotid artery's atherosclerotic plaque content and stability, and its~     relation to plasma's enzyme concentration.~   "
123434|NCT01440023|"~     Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor~     cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate~     response such as vocal or motor tics. The investigators aim to test whether a~     well-established behavior therapy for TS can be improved by increasing the individual's RI~     capabilities. To this end, 20 children will be randomly assigned to behavior therapy with~     computer-based RI training or behavior therapy with placebo computer-based cognitive~     training. The investigators will test the hypothesis that computer-based RI training can be~     a useful addition to the well-established behavior therapy to enhance its therapeutic~     effect.~   "
123435|NCT01440010|"~     Quality control of IORT as a boost with 20 Gy followed by EBRT~   "
123436|NCT01439997|"~     The objective of this study is to find out what the pharmacodynamic (PD) characteristics of~     desmopressin melt are in nocturia patients (compared to healthy volunteers and children).~     The main questions the investigators want to answer are:~        -  Are differences related to the pathophysiological factors involved in nocturia?~        -  Are there age/gender/size differences?~        -  Can the investigators identify patients who are likely to develop hyponatraemia?~        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?~      The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy.~     During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to~     bed.~      There are two groups of patients:~      Group A:~      Patients that still have to undergo an evaluation phase, according to standard procedures~     (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study~     starts when the 1st Minirin Melt tablet has been taken (= day 1).~      Group B:~      This group already went through the evaluation phase (by participation to study 1 or study 3~     as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.~      The study starts when the patients takes his first prescribed Minirin Melt tablet:~        -  On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control~          (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2~          visits (day 3 and day 7) are standard procedure. If the patient is at high risk for~          side effects, blood has to be taken during the first 7 days.~        -  On day 3 the patient has to give a urine sample.~        -  Patients have to fill out a frequency/volume chart during the first 14 days.~        -  On day 30, a 3rd blood sample will be taken~   "
123437|NCT01439984|"~     The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the~     treatment of premature ejaculation.~   "
123441|NCT01439932|"~     Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the~     population during life. This is a degenerative condition of the plantar fascia at its~     insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning~     or after prolonged lack of weight bearing. The pain intensity can be very high and this can~     cause functional limitations and reduce quality of life.~      Despite the high prevalence of the PF, treatment is controversial and not supported by~     extensive research. Review of the previous studies on various treatments, mentioned steroid~     injections, shock waves, night splint, orthotics, heel padding and stretching exercises.~      Limitation of ankle dorsi flexion is a common finding and thought to be a contributing~     factor to the development of pathology. So far, this issue had been addressed mainly by soft~     tissue therapy techniques to improve ankle range of motion in patients with PF. Only one~     study (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However,~     in this study mobilizations were part of complex therapy and therefore the effect of~     treatment cannot be attributed solely to them.~      The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints~     mobilization on pain and function of patients with PF.~      The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to~     conventional physical therapy will improve pain and function significantly more than~     conventional treatment, in patients with PF.~      Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will~     be recruited and randomly divided into two groups. Both groups will receive commonly~     accepted physical therapy treatment that includes stretching exercise of the plantar fascia~     and triceps surae muscles and ultrasound therapy at the site of symptoms. The study group~     will receive in addition manual mobilizations to the ankle and midfoot joints. The~     procedures will take place at the physiotherapy clinic Bat-Yamon of General Health Services~     and will last four weeks, twice a week.~   "
123442|NCT01439919|"~     The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily~     compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric~     Rating Scale (NRS).~      Secondary Objectives are:~        -  To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency,~          background therapy utilization, mood, patient satisfaction of pain relief, nausea,~          constipation, healthcare utilization and quality of life;~        -  To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for~          persistent cancer pain;~        -  To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and~          cancer pain treatment;~        -  To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for~          persistent cancer pain;~        -  To assess endocannabinoid plasma concentrations.~   "
123443|NCT01439906|"~     The study aims to analyze the surgical treatment of low back pain due to degenerative~     kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico~     Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of~     back pain and functional ability before and after the surgical treatment will be performed~     by administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry~     Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be~     matched to a purely objective and radiological assessment according to international~     guidelines. A psychological analysis will be also performed in order to evaluate~     co-morbidity from this field, considering that the concept of shared decision-making for~     the therapeutic approach to low back pain requires the evaluation of all these parameters.~   "
123444|NCT01439893|"~     This is a multi-center, randomized, double-blind , placebo parallel controlled, standard~     therapy based phase III clinical trial, to evaluate the efficacy of recombinant human~     neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart~     failure.~   "
123445|NCT01439880|"~     The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be~     safe and well tolerated in subjects with hypercholesterolemia.~   "
123446|NCT01439867|"~     This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain~     on study for 26 weeks or until time of kidney transplantation, whichever comes first. All~     subjects, in addition to receiving cinacalcet, will receive standard of care, which may~     include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).~     Subjects who complete the 26-week study may be eligible to participate in an extension study~     (Study 20140159).~   "
123447|NCT01439854|"~     The purpose of this study is to examine the effect of the chronic treatment of type 2~     diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and~     insulin signaling/action and (2) oral glucose tolerance and beta cell function.~     Dapagliflozin is a potent, highly specific inhibitor of renal glucose transport [SGLT2].~   "
123448|NCT01439841|"~     HIV progression is closely associated with chronic immune activation driven by leakage of~     bacterial products from a damaged gut, the investigators largest immunological organ.~     Notably, the degree of immune activation has been suggested to be a better predictor of~     disease progression than plasma viral load, and markers of immune activation and gut damage~     have been identified as therapeutic targets per se. The major damage by HIV to the immune~     system is an initial massacre of gut mucosal CD4+ Th17 cells. Interestingly, a normal gut~     flora has been shown to induce the maturation of Th17 cells in the small intestine mucosa.~     Preliminary reports have shown that the gut flora is altered in HIV-1 infection compared to~     controls. In this project, the investigators will characterize microbial composition of gut~     flora in chronic HIV infection with ultradeep sequencing. Gut flora composition will be~     related to clinical data as well as quantitative data of circulating microbial products and~     activation markers. Second, in a randomized clinical trial (RCT) the effect of probiotic~     lactobacilli on HIV pathogenesis and progression will be tested. This Gram-positive strain~     is clinically tested and is able to colonize the gut.~   "
123449|NCT01439828|"~     The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo~     during 4 weeks in cannabis withdrawal.~   "
123450|NCT01439815|"~     The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal~     spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms~     following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home~     dosing.~   "
123451|NCT01439802|"~     The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices~     (IUDs) placed at time of Cesarean Delivery.~   "
123452|NCT01439789|"~     Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based~     phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on~     serum NT-proBNP, as well as safety in patients with chronic heart failure.~   "
123453|NCT01439776|"~     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy~     obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3~     Studies rarely address the issues of improving host factors. The current study examines~     whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral~     response(SVR)compared to Peg/RBV.~   "
123454|NCT01439763|"~     The specific aims of this study are:~        -  To determine the prevalence of bullying in children who present to the ED with~          behavioral symptoms~        -  To assess mental health diagnoses and their relationship to type, severity and~          frequency of bullying behaviors, as well as demographic and psychosocial correlates~          (socioeconomic status, stress and support) and their relationship to type, severity and~          frequency of bullying (bullies versus victims).~        -  To explore the attitudes, values, triggering events and potential solutions using~          qualitative methods~        -  To gain greater insight into the patient experience and perceptions of the bullying~          events~   "
123455|NCT01439750|"~     This is a phase I/II trial of bortezomib, cladribine, and rituximab in newly diagnosed and~     relapsed mantle cell lymphoma (MCL). The phase I component has three dose levels of~     cladribine (3 mg/m2, 4 mg/m2, and 5 mg/m2) and is designed as a traditional dose-escalation~     study in which cohorts of 3 patients are evaluated for the incidence of dose-liming toxicity~     (DLT) at each dose level. Once the maximum tolerated dose (MTD) is determined, a phase II~     component with 2 arms will begin. One arm will enroll newly diagnosed MCL patients and one~     arm will enroll relapsed MCL patients. Each arm is a single-stage, fixed sample size study~     and will be accrued and analyzed separately. The phase I and II data will also be analyzed~     separately.~   "
123456|NCT01439737|"~     Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the~     clinical manifestations and treatment responses in these patients. Metabolomics is a~     large-scale approach to monitoring as many as possible of the compounds involved in cellular~     processes in a single assay to derive metabolic profiles. Compared with genomics or~     proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now,~     few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic~     evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly~     developed, noninvasive method that may allow clinicians and researchers to assess~     biochemical profiles in the alveolar lining fluid. This study will apply metabolomics to~     examine the biomarkers in the EBCs, serum and urine specimens in adult asthmatics.~   "
123457|NCT01439724|"~     Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas~     patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level~     laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This~     study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the~     incidence and/or severity of oral mucositis.~   "
123458|NCT01439711|"~     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by~     lowering the amount of estrogen the body makes.~      PURPOSE: This phase II trial is studying how well letrozole works in treating women with~     ductal carcinoma in situ.~   "
123459|NCT01439698|"~     The objective of this protocol is to establish a multicenter registry to evaluate the impact~     of radiofrequency ablation in the management of patients with pancreatico-biliary disorders~     including malignancies.~   "
123460|NCT01439685|"~     This study entails retrospective and prospective review of data from a database protocol.~     Data gathered will be then analyzed for a set amount of patients. In this study, the~     investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy~     (PDT) and assess if PDT can improve quality of life and prolong survival.~   "
123461|NCT01439672|"~     This protocol will investigate physiological parameters including insulin sensitivity and~     counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with~     type I diabetes.~   "
123462|NCT01439659|"~     The goal of this clinical research study is to see if ovarian cancer patients who add Juice~     PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian~     cancer patients who receive only dietary counseling alone.~   "
123463|NCT01439646|"~     Retrospective, observational study To study the effect of Empirical Antifungal therapy on~     clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in~     ICU/Critical care unit, To know the current epidemiology of IFI and management approach in~     patients at high risk of Invasive fungal infections, Identify the risk factors associated~     with Invasive fungal infections, To comment on the appropriateness of empirical therapy used~     based on proven/probable diagnosis~   "
123464|NCT01439633|"~     The specific aim of this study is to determine the feasibility of marking target pathologic~     locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial~     cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of~     biopsy.~   "
123465|NCT01439620|"~     The goal of this study is to evaluate the potential of comprehensive biliary Optical~     Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct~     strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing~     cholangitis (PSC).~   "
123466|NCT01439607|"~     Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the~     defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside~     particularly in cells of the macrophage lineage. Clinical manifestations associate~     hematological, neurological and bone disorders.~   "
123467|NCT01439594|"~     The goal of this research is to conduct a pilot clinical study to evaluate the potential use~     of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree~     of injury associated with therapeutic radiofrequency ablation techniques.~   "
123468|NCT01439581|"~     To determine if a device that measures and displays pressure that the patients feel when in~     bed can help nurses reposition the patient effectively and thereby reduce bedsores in the~     intensive care unit.~   "
123469|NCT01439568|"~     The purpose of this trial is to compare the progression free survival of LY2510924 +~     carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with~     extensive-stage disease small cell lung cancer (SCLC)~   "
123470|NCT01439555|"~     Purpose of the study: Patients with mild Alzheimer's Disease will be given three different~     drugs over a 4-month period to try to increase the blood flow to their brains, and improve~     blood vessel and brain function. Each drug can help to open the blood vessels in the brain,~     and together they may be more effective than each drug alone. The hypothesis is that small~     blood vessels secrete substances that maintain the integrity of the brain, and may prevent~     loss of nerve cells leading to Alzheimer's Disease~   "
123472|NCT01439529|"~     New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated,~     such as the use of the electrocardiogram.~      In this prospective, double-blind, study, the investigators will evaluate:~      Primary endpoint: To compare the clinical response to CRT in patients with the programming~     optimized by QRS versus the nominal suggested by the device.~      Secondary endpoints:~        1. To compare cardiac remodeling in patients with the programming optimized by QRS versus~          the nominal suggested by the device.~        2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by~          QRS) with respect to the intrinsic rhythm.~        3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both~          groups.~        4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial~          sensing or atrial pacing.~      For that, 180 patients with an indication for CRT will be randomized to nominal programming~     of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and~     echocardiographic evaluation will be done at baseline, 6 and 12 months.~   "
123473|NCT01439516|"~     African Americans are less likely than Whites to receive kidney transplants, despite their~     being more than two-fold as likely as Whites to develop end stage renal disease (ESRD).~     Living related kidney donation (LD) offers patients an opportunity to bypass many barriers~     to receipt of deceased kidney transplants (e.g. waiting lists and immunological~     incompatibility), but minorities are less likely to receive living related kidney~     transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their~     families or physicians at optimal rates, and thus may not have adequate information to~     initiate or participate in shared decision-making regarding LD/LRT. African Americans may~     also have financial concerns regarding convalescence and out of pocket expenses related to~     LD/LRT, another barrier impeding LD/LRT.~      The primary goals of this study are to overcome these important barriers by enhancing ethnic~     minorities' consideration of LD/LRT through the promotion of shared decision-making~     regarding LD/LRT and provision of financial assistance for out of pocket expenses. The~     investigators specific aims are: a) to develop culturally sensitive informational~     (audiovisual) and financial interventions and b) to perform a randomized controlled trial to~     assess their effectiveness in increasing pursuit of LD/LRT among African American patients~     with ESRD and their families. The investigators hypothesize: (1) Patients and families who~     view informational materials designed to promote shared decision-making regarding LD/LRT~     will be more likely than patients and families not viewing these materials to discuss LD/LRT~     with family and with health care professionals. Patients and families viewing such~     informational materials will also be more likely than those not viewing these materials to~     pursue and complete the LD/LRT process and (2) patients and their families who are offered~     the intervention to promote shared decision-making plus a financial assistance intervention~     for potential live kidney donors will be more likely than patients and families not offered~     both interventions to pursue and complete the LD/LRT process.~   "
123474|NCT01439503|"~     To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620~     eligible African American men who have sex with men (MSM) will be conducted. Men in the~     treatment condition will be compared to men receiving the control condition comprised of~     standard of care counseling from the clinic plus a free bag of condoms and water-based~     lubricants. This two-arm trial will test four hypotheses:~      Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed~     to reduce STD incidence and risk of HIV acquisition/transmission among young African~     American men (15-29 years old) having sex with men and presenting for STD testing.~      H1. Men randomized to receive the intervention will have a lower incidence rate of~     laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving~     the control condition.~      H2. Men randomized to receive the intervention will report significantly fewer acts of~     unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments~     compared to those receiving the control condition.~      H3. Men randomized to receive the intervention will report having significantly fewer~     unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between~     follow-up assessments compared to those receiving the control condition.~      H4. Men randomized to receive the intervention will report having significantly fewer~     negative experiences with condom use between follow-up assessments compared to those~     receiving the control condition.~      H5. Men randomized to receive the intervention will demonstrate significantly greater~     improvement in condom application skills, throughout the 12-month study, compared to those~     receiving the control condition.~   "
123475|NCT01439490|"~     Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER)~     alpha and beta are present in 20-100% of ovarian cancer patients. For this reason,~     antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive~     treatment option. However, only a small proportion of patients (5-19%) will respond to~     antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron~     emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators~     will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian~     cancer. If these results are positive, this would warrant further exploration of FES-PET~     imaging in ovarian cancer.~   "
123476|NCT01439477|"~     Cardiovascular disease (CVD) is the leading cause of death for women in the United States.~     CVD disproportionately affects underserved populations, specifically low-income, minority,~     and rural women who have higher obesity rates and experience other health disparities. There~     is a need for replicable, evidence-based programs that target women, particularly midlife~     and older women who represent an increasing proportion of the U.S. population, to reduce~     their CVD risk . StrongWomen - Healthy Hearts is a 12-week, community-based program that has~     demonstrated effectiveness at improving CVD risk factors, including body weight, diet~     quality, and physical activity in a controlled, randomized trial conducted with midlife and~     older overweight and obese subjects in Arkansas and Kansas.~      The central objective is to rigorously evaluate dissemination of the StrongWomen - Healthy~     Hearts Program using the RE-AIM framework to achieve maximal public health impact. Expanded~     dissemination will occur through the Cooperative State Research, Education and Extension~     Service (CSREES) This partnership will leverage a long and successful collaboration between~     Tufts University and CSREES that provides strength training programs to older women in 41~     states.~   "
123477|NCT01439464|"~     The goal of this study is to compare Bonglass-SS with titanum cage.~   "
123478|NCT01439451|"~     The proposed project is a prospective experimental Randomized Control Trial study design.~     Independent old adults (age 70 years old and older) who do not suffer from balance problems~     willing to participate in the study will be tested before and after Peturbation balance~     training during walking to explore whether there are differences in balance control and~     balance reactions as a result of training.~   "
123479|NCT01439438|"~     This study is prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the~     reference or the test formulation, according to the randomization list, under fasting~     conditions, in order to evaluate if the reference and test formulations are bioequivalent.~   "
124916|NCT01420601|"~     To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion~     particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start~     of administration.~   "
123480|NCT01439425|"~     The relative risk of psoriasis and its severity are directly related to the body mass index~     (BMI).Patients with psoriasis likely undergo a vicious circle where obesity and skin disease~     reinforce each other. To investigate patients' opinion about their body weight (BW), the~     possibility of dietary approach to psoriasis, and to examine the adherence and the effects~     of hypo-energetic diet to maintain disease remission in obese patients a dedicated~     questionnaire was administered to 200 consecutive patients (125 men and 75 women) with~     moderate-to-severe chronic plaque psoriasis investigating whether diet factors could~     influence psoriasis severity and course. In second part of study, obese patients with~     psoriasis in remission (PASI improvement ≥ 75%) for at least 12 weeks after methotrexate~     therapy were randomly assigned to receive a hypo-caloric diet or free diet for 24 weeks, and~     then followed up for additional 12 weeks.~   "
123481|NCT01439412|"~     Acute low back pain is a common disorder in general practice. Some general practitioners~     (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its~     effectiveness for this condition.~      The aim of this study is to evaluate whether a single treatment-session with acupuncture can~     reduce time to recovery when applied in addition to standard LBP-treatment according to the~     Norwegian national guidelines. Analyses of prognostic factors for recovery and~     cost-effectiveness will also be carried out.~      The investigators hypotheses are:~        1. Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to~          standard treatment in general practice provided in accordance with the Norwegian~          national guidelines.~        2. Acupuncture treatment for acute LBP improves function, and reduces drug use and sick~          leave, compared to the standard treatment in general practice provided in accordance~          with national guidelines.~        3. Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.~      The investigators intend to include a total of 270 patients, 135 in the intervention group~     and 135 in the control group.~      The investigators planned to do an interim analysis when reaching inclusion of 150 patients.~     However, this might lead to reduced overall significance level, and as a result of slow~     inclusion rate (by December 2015), the investigators plan to extend the inclusion time with~     one year and then complete the study in March 2017.~   "
123482|NCT01439399|"~     The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine~     and ketamine in the perioperative period of abdominal surgery.~   "
123483|NCT01439386|"~     This prospective, multi-center, single blinded study aims to compare the influence of two~     different catheter ablation strategies, on long-term ablation outcome in terms of AF~     recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The~     two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF)~     with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.~   "
123484|NCT01439373|"~     GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of~     chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and~     pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and~     ribavirin in subjects with chronic hepatitis C (CHC).~   "
123485|NCT01439360|"~     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK~     Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine~     comparators in children 6 to 35 months of age. Recruitment will encompass at least 4~     independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort~     in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a~     fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and~     subtropical countries (beginning 2014).~   "
123486|NCT01439347|"~     A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute~     lymphoblastic leukemia (ALL).~   "
123487|NCT01439334|"~     The primary purpose of this research is to develop and evaluate the short-term efficacy of~     an innovative multiple behavior screening, brief intervention and referral to treatment~     (MB-SBIRT) model using social images and future self-images to simultaneously link and~     reduce prescription and other co-occurring drug use behaviors among emerging adults in a~     primary care setting serving a racially and economically diverse community. The long term~     objective of this research is to cost-effectively reduce prescription and illicit drug~     abuse, along with alcohol and tobacco consumption, and improve health-related quality of~     life among high-risk emerging adults often ignored in intervention research and services.~   "
123488|NCT01439321|"~     Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and~     the risk of severe bleeding complications. The two recently introduced TPO-RA drugs, namely,~     eltrombopag and romiplostim, have shown efficacious sustained response with continuous~     administration. Both drugs are indicated for the treatment of thrombocytopia in patients~     with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins,~     or splenectomy. While these trials address important clinical questions they were not~     intended to evaluate what happens in the real-world settings with actual patient living~     daily lives. The purpose of this health outcomes study is to understand how the two TPO~     receptor agonists (TPO-RA) currently available in the US are being used in clinical practice~     and how their use impacts chronic ITP patients' daily lives. The study hypothesis is that~     patients who switched to eltrombopag report a better health-related quality of life than~     those who switched to romiplostim. This study utilized a hybrid design of retrospective~     chart review study and cross-sectional patient survey. A customized Patient Case Report Form~     (CRF) will be used to retrospectively collect clinical data from patient medical charts~     where the primary cohorts consist of patients who have switched from other ITP medication to~     eltrombopag or romiplostim. A cross-sectional survey will be employed to collect patient~     reported outcomes (PRO) data, including health-related quality of life and treatment~     satisfaction, using a compository questionnaire. Analyses of cross-sectional survey data and~     retrospective medical chart review data in patients who switch to either eltrombopag or~     romiplostim from their prior primary therapy will be conducted.~   "
123489|NCT01439308|"~     This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced~     by capsaicin challenge~   "
123490|NCT01439295|"~     Urinary ascorbyl peroxide level in the first week of life will be a good predictor of~     Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.~   "
123492|NCT01439269|"~     The purpose of this study is to test the efficacy of a family nurture intervention in the~     neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family~     nurture are compared to infants receiving standard NICU care. The intervention enhances~     mother/infant interactions that are vital to early development in the infant. The main goal~     is to get the mother and infant into biological synchrony, emotional attunement and mutual~     calm through an activity referred to as a calming cycle. Mother's are encouraged to engage~     in the calming cycle activities as much as possible. Her increased effectiveness in calming~     her infant is hypothesized to improve the mother's view of her baby, reduce negative~     emotions about having delivered a baby prematurely, and help her gain confidence in her~     care-taking abilities, which in other studies predicted shorter length of stay and fewer~     re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle~     activities providing appropriate types of stimulation for their babies that are important~     for social, emotional, and neurobehavioral development. Since preterm babies are often~     easily upset, mothers will be taught how to comfort and calm their babies. Assessments in~     the NICU and in follow-up visits for two years will test the immediate and long-term effects~     of this new approach to the nurture of prematurely born infants.~   "
123493|NCT01439256|"~     This study focuses on an important patient behavior, medication-taking, and important~     physician behaviors: promoting medication regimen adherence in patients and appropriately~     modifying therapy when existing therapy results in inadequate therapeutic effect. The study~     will also explore the caregivers' (clinicians) behavior after relevant information about~     their patients' medication adherence and blood pressure control has been provided to them.~     The investigators focus on behavior change for patients and physicians and seek to change~     their behaviors to improve the health care delivery process and outcomes. The study aims at~     facilitating tertiary prevention of cardiovascular, cerebrovascular, and reno-vascular~     diseases by promoting better blood pressure control.~   "
123494|NCT01439243|"~     The objective of this study was to compare the rate and extent of absorption of donepezil 10~     mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed~     conditions.~   "
123495|NCT01439230|"~     The objective of this study was to compare the rate and extent of absorption of donepezil 10~     mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under~     fasting conditions.~   "
123496|NCT01439217|"~     Specific Aim: Compare the endothelial function, arterial stiffness and components of~     metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy~     sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls~     including measures of endothelial function and arterial stiffness obtained form a peripheral~     artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and~     insulin.~   "
123497|NCT01439204|"~     The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)~     drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers~     Squibb are comparable in healthy subjects~   "
123498|NCT01439191|"~     The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human~     breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a~     humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment~     for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy~     has been shown to increase both survival and response rate, in comparison to trastuzumab~     alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian~     Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination~     with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast~     cancer.~   "
123499|NCT01439178|"~     Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal~     bevacizumab (IVB) in proliferative diabetic retinopathy.~      Design: Prospective, open-label, controlled, randomized interventional clinical trial.~      Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana~     vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.~      Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before~     ppV. Aqueous humor samples were taken from anterior chamber just before IVB and at the time~     of surgery. Multiplex cytokine array were used to assay various cytokines~   "
123500|NCT01439165|"~     The purpose of this study is to describe the safety and immunogenicity of repeat~     administration of Adacel vaccine approximately 10 years following initial administration of~     the vaccine. Antibody levels prior to revaccination will also be used to characterize~     antibody persistence following initial vaccination 10 years earlier.~      Primary Objectives:~        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel~          vaccine to those induced by Td Adsorbed vaccine.~        -  To compare booster response rates against tetanus and diphtheria induced by Adacel~          vaccine to those induced by Td Adsorbed vaccine.~        -  To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by~          Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.~      Secondary Objectives:~        -  To describe the rates of immediate reactions, solicited reactions, unsolicited adverse~          events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td~          Adsorbed vaccine.~        -  To describe booster response rates for pertussis antigens following revaccination with~          Adacel vaccine.~   "
123501|NCT01439152|"~     BAY94-9343 is an antibody-drug conjugate (ADC) directed against the cancer antigen~     mesothelin on tumor cells. This study will attempt to answer the following questions:~        -  What are the side effects of BAY94-9343 when given at different dose levels and~          schedules?~        -  What dose level and schedule of BAY94-9343 should be tested in future clinical research~          studies?~        -  How much BAY94-9343 is in the blood at specific times after administration?~        -  Does the treatment with BAY94-9343 show any effect on the tumor growth?~        -  Are there specific biomarkers that might be able to explain why some patients respond~          to treatment and others do not?~   "
123502|NCT01439139|"~     The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS)~     versus densitometry (DXA) in osteoporosis detection.~   "
123503|NCT01439126|"~     The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™~     (clonidine hydrochloride) extended-release in children and adolescents with Attention~     Deficit Hyperactivity Disorder (ADHD)~   "
123504|NCT01439113|"~     The placement of peripheral intravenous lines (IVs) is central to the treatment of patients~     in the emergency department (ED). The procedure is used for phlebotomy and administration of~     a variety of therapeutic medications and intravenous fluids. This procedure is standard of~     care, and IVs are routinely placed by experienced emergency nurses.~      Occasionally, the nurse will have difficulty placing an IV line. The most common reason for~     this is an underlying medical condition, such as diabetes, severe peripheral vascular~     disease, obesity, or a history of intravenous drug use. When a nurse is unable to place an~     IV, the options are:~        1. Ask another nurse to attempt the line placement~        2. Ask a physician to establish access, which usually involves placement of a central~          venous catheter, a time-consuming procedure with higher risk of infection than a~          peripheral line.~      The use of bedside ultrasound has become commonplace in the modern ED, and the Tufts Medical~     Center ED possesses its own machine, which is used for a variety of indications including~     diagnosis of pregnancy, gall bladder disease, abdominal free fluid or pericardial effusion.~     Another key use of bedside ultrasound is the location of blood vessels. In fact, it is now~     expected that when placing a central venous catheter the clinician use ultrasound guidance,~     as the ultrasound clearly demonstrates blood vessels. The procedure is completely pain-free~     and harmless, and costs nothing to perform.~      Recently, there has been a growing body of evidence demonstrating that placement of~     peripheral IVs can be facilitated by the use of ultrasound. Just as it is useful for central~     venous catheters, ultrasound can also clearly show smaller peripheral veins. Multiple~     studies have demonstrated that physicians can place IVs with ultrasound guidance.~      However, nurses are the de facto experts at placing peripheral IVs as it is a usual~     procedure for them to perform and they perform the procedure multiple times a day. In this~     study, we will provide a two-hour training program to a cohort of nurses. The training~     program will instruct them in the use of single-operator ultrasound-guided IV placement.~     After training, once the nurse encounters a patient with difficult IV access (either 2~     failed attempts or history of difficult access), the patient will be consented and~     randomized to either the standard of care (whatever the nurse elects to do) or use of the~     bedside ultrasound.~      In the meantime, the research assistant will measure time to IV placement starting from~     enrollment, the number of skin punctures that are necessary to place the IV, and then ask~     the patient questions about satisfaction with the IV placement and the pain they~     experienced.~      Our hypothesis is that single-operator, ED nurse use of bedside ultrasound will facilitate~     IV placement in patients with difficult IV access, saving time and also improving patient~     satisfaction and comfort.~   "
123505|NCT01439100|"~     To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy~     in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed~     by averaged 24 hour pain scores collected for 7 days prior to the clinic visits~   "
123506|NCT01439087|"~     The goal of this research is to conduct a pilot clinical study to image colonic polyps with~     the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to~     identify the extent of invasion (if present), differentiate between hyperplastic polyps and~     adenomas, and identify serrated polyps.~   "
123507|NCT01439074|"~     The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag)~     compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn~     injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will~     be up to 4 weeks with either Mepilex Ag or SSD.~   "
123508|NCT01439061|"~     This is an Italian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
123509|NCT01439048|"~     The purpose of this study is to determine if changes in specific gene products in the~     placenta or cord/infant blood affect a baby's birth weight, increase the risk of premature~     birth, or increase the risk of developing diseases of prematurity. We would also like to~     characterize whether placental epigenetic changes or placental markers of environmental~     exposures are associated with premature birth.~   "
123510|NCT01439035|"~     The goal of this research is to conduct a pilot clinical study to image Celiac disease~     characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to~     histologic evaluation in children, adolescents and young adults with suspected Celiac~     disease.~   "
123511|NCT01439022|"~     This study sets out to determine the effect of exercise performed over a longer period of~     time (6 months), delivered using community facilities, on motor and non motor symptoms,~     health and well being in people with Parkinson's Disease.~   "
123512|NCT01439009|"~     One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the~     morning for up to 14 days to heart failure patients with volume overload that does not show~     adequate response to other diuretics such as loop diuretics in order to investigate the~     effect of tolvaptan on the mid- to long-term prognosis of the target population. The~     efficacy of tolvaptan during the treatment period will also be investigated.~   "
123513|NCT01438996|"~     The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi~     antibody response following secondary vaccination with the Novartis Vaccines Institute for~     Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either~     the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and~     the immunogenicity and the kinetics of the anti-Vi antibody response following primary~     vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.~   "
123514|NCT01438983|"~     This is an observational, non-randomised trial to evaluate the effect of dietary type on~     infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45~     breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular~     pediatric appointment. Infants with unremarkable health histories, normal weight, free of~     sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also~     healthy and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of~     antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and~     mammary candidiasis in mothers were exclusion criteria.~   "
123515|NCT01438970|"~     This is a single centre, prospective, uncontrolled study to include 12 consecutive patients~     with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary~     objective) of the study is to investigate the effect of treatment of ascites by the Sequana~     medical pump on the renal and circulatory function in patients with cirrhosis and recurrent~     or refractory ascites. The secondary objectives are the following:~        -  To evaluate the efficacy of treatment for handling ascites, associated with changes in~          the body weight of patients and their requirements for evacuation paracentesis during~          follow-up.~        -  To investigate the effects of treatment on bacterial translocation, by means of~          determining bacterial DNA.~        -  To determine the incidence of complications associated with treatment in the course of~          follow-up.~        -  To evaluate the effect of treatment on quality of life of the patients treated,~          evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease~          questionnaire).~   "
123516|NCT01438957|"~     The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine)~     in patients who require sedation during the surgery that requires epidural or spinal~     anesthesia without intubation under monitored sedation care.~   "
123517|NCT01438944|"~     Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of~     smoking delivers nicotine through lungs into the blood stream. As a result, during smoking~     nicotine levels peak and then when smoking stops levels progressively diminish to a base~     (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker~     starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and~     Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine~     patches do not. Instead, nicotine patches deliver a constant base dose considered to be~     either above that of the smokers trough level or at a level where negative withdrawal~     effects are reduced.~      The question arises as to if nicotine levels delivered by a patch are constant and~     potentially above that of the baseline smokers level, does this reinforce the addiction and~     therefore contribute to the high long term relapse rate? To answer this question the~     investigators will be looking at metabolites which the body uses to breakdown nicotine and~     several other enzymes. These metabolites respond to the levels of nicotine in the blood~     stream by increasing or decreasing over time. By testing blood flow, blood and urine the~     investigators are able to gain an insight into how the body is dealing with a constant~     stable dose of nicotine rather than a peak and trough dose. In combination with the~     questionnaires the investigators will be able to determine the level of affect.~   "
123518|NCT01438931|"~     The purpose of this study is to evaluate the efficacy and the safety of DA-9501~     (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation~     under monitored sedation care.~   "
123519|NCT01438918|"~     The objective of this 2-year study is to evaluate the safety, tolerability and disease~     modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The~     efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the~     medial tibiofemoral compartment of the study knee as the primary endpoint.~   "
123520|NCT01438905|"~     The purpose of this study is to examine the effects of a gentle pressure movement performed~     at the ankle by a physical therapist on muscle function and ankle motion in individuals who~     frequently twist (sprain) their ankle.~   "
123521|NCT01438892|"~     Several observational studies have evaluated the comparative treatment costs associated with~     each agent, particularly those within the anti-TNF class, but few have evaluated the impact~     of therapy compliance, persistence, treatment patterns on patient reported outcomes,~     healthcare utilization and costs, using a provider database. This study is designed to fill~     in this information gap.~   "
123522|NCT01438879|"~     Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central~     nervous system infections.~      Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system~     (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF)~     polymerase chain reaction (PCR)-result for the virus.~      The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in~     the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the~     patients with normal CSF leukocyte count.~   "
123523|NCT01438866|"~     Sealants have been shown to be the most effective caries preventive measure in permanent~     dentition. Sealants of the primary molars soon after they erupt would reduce the total~     caries experience of the primary teeth of the children and could possibly also postpone the~     caries process in the permanent dentition.~      The aim of this study is to measure the caries preventive effect of sealants in primary~     molars. The specific objectives are: 1) to compare the number of new caries experience teeth~     and surfaces among the intervention group of 4-years old pre-school children during the 1~     year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish~     on the caries experience on the occlusal surfaces of the primary molars and on the total~     caries experience of all the primary and permanent teeth, 3) to test the feasibility of the~     sealant program in one kindergarten in Kuwait city.~   "
123524|NCT01438853|"~     This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded~     dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in~     subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least~     six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to~     receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15~     minutes. Three cohorts of subjects were enrolled to the study and safety and~     pharmacokinetics of the study treatment were evaluated.~   "
123525|NCT01438840|"~     Core Study:~      To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is~     superior to placebo (in addition to standard of care) for the treatment of adult~     participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura)~     (ITP) as measured by cumulative number of weeks of platelet response over 6 months of once~     daily treatment in adults participants who received at least 1 prior ITP therapy.~      Extension Phase:~      To evaluate the safety and tolerability of long-term therapy with avatrombopag in~     participants with chronic ITP (cITP).~   "
123526|NCT01438827|"~     The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+~     (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen~     induced allergic rhinoconjunctivitis with or without asthma.~   "
123527|NCT01438814|"~     The aim of this study is to investigate the impact of the combination therapy of linagliptin~     and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and~     metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of~     with type 2 diabetes mellitus.~   "
123528|NCT01438801|"~     The evaluation of a standardized diagnostic test to predict the growth response in a 1 year~     trial with Growth Hormone (GH) treatment (carried out in the context of regular patient~     care) in non GH deficient short children with low serum insulin-like growth factor-1~     (IGF-1).~   "
123566|NCT01438307|"~     Lung cancer is the leading cause of cancer death worldwide and in the United States. The~     majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases~     are advanced at the time of diagnosis. Chemotherapy has improved overall survival but~     remains limited at < 12 months median overall survival. New approaches are needed for second~     line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in~     metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.~   "
123529|NCT01438788|"~     -  This is a 2 stage exploratory study with a 3-month observational phase on the natural~          course, followed by a 12-month, open-label, non-comparative, single-arm, phase II pilot~          study on the efficacy, safety and tolerability of a low-protein diet (LPD) in 8 adult~          patients with Bethlem myopathy (BM) and Ullrich congenital muscular dystrophy (UCMD).~        -  Objective of this trial is to test the effect of a normocaloric LPD to reactivate~          autophagy in BM/UCMD patients. The primary end point of the study will be the change in~          muscle biopsy of Beclin 1, a marker of autophagy, at 1 year of LPD treatment when~          compared to baseline.~        -  The rationale rests on our discoveries that (i) mitochondrial dysfunction mediated by~          inappropriate opening of the PTP plays a key role in collagen VI myopathies; (ii)~          defective autophagy with impaired removal of defective mitochondria amplifies the~          defect; and (iii) reactivation of autophagy with a low-protein diet or treatment with~          cyclosporine A, the mitochondrial PTP inhibitor, cured Co6a1-/- mice, hinting at a~          common target among all beneficial treatments - namely autophagy.~        -  Specific aims of this project are to (i) study the modifications of clinical,~          nutritional and laboratory parameters in a cohort of patients with BM/UCMD during a~          3-month observational period before starting the LPD treatment; (ii) assess the effect~          of a normocaloric LPD in correcting defective autophagy in muscle of patients; (iii)~          test if new non-invasive biomarkers of activation of autophagy examined in the blood~          are mirroring the effect of LPD in the muscle biopsy; (iv) assess the clinical efficacy~          and safety of the LPD with an innovative combination of complementary measures of the~          nutritional status in patients.~        -  The anticipated output is defining and validating a therapeutic nutritional approach in~          autophagy upregulation for BM/UCMD.~   "
123530|NCT01438775|"~     This study is designed to demonstrate the safety and efficacy of a second transrectal~     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia~     (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of~     NX-1207.~   "
123531|NCT01438762|"~     Self-reported, unspecific knee pain is highly prevalent among adolescents. A large~     proportion of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome~     (PFPS). There are a number of treatment options for PFPS. Physical therapy has been~     advocated as one of the cornerstones in rehabilitation of patients with PFPS. Twenty-five~     years ago, McConnell proposed a multimodal approach that combined several treatment options.~     The regimen included retraining of the vastus medialis oblique muscle through functional~     weight bearing activities. This exercise is combined with patellar taping, patellar~     mobilization, and stretching to improve patellar tracking, reduce pain, and enhance vastus~     medialis oblique muscle activation. Short term results (<12 months) indicates that~     multimodal physiotherapy is more effective than placebo treatment.~      While treatment for PFPS may be successful for the short-term, long-term results are less~     promising. A recent review covering the long term prognosis for patients diagnosed with~     PFPS, reported that only 1/3 of those diagnosed with PFPS and treated conservatively were~     pain free 12 months after diagnosis. Further ¼ stopped participating in sports because of~     knee pain.~      Predictors of long term outcome (>52weeks) indicate that a long symptom duration, higher age~     and greater severity at baseline are associated to poorer outcome after treatment. These~     prognostic factors suggest that an early initiation of treatment might lead to a better~     long-term prognosis. The purpose of this study is to examine the short and long-term~     effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment~     applied at a very early state of disease among adolescents. The investigators hypothesized a~     significantly larger proportion of completely recovered patients at three-month follow-up in~     the interventions group compared to the control group.~   "
123532|NCT01438749|"~     This randomized, placebo- and active-controlled, crossover study will evaluate the abuse~     liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1),~     subjects will receive a single dose of either diazepam or placebo in an inpatient crossover~     design, with a wash-out period of at least 10 days between treatments. Subjects who are~     clearly able to distinguish the positive control from placebo will be enrolled in the main~     study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels),~     diazepam and placebo in a double-blind, double-dummy inpatient crossover design.~     Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.~   "
123533|NCT01438736|"~     The purpose of the study is to examine how well three months preceding use of Cerazette~     progestin only pill predicts the bleeding pattern during following Nexplanon implant use.~   "
123534|NCT01438723|"~     Rationale:~      In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial~     ischemia and cell death. If untreated, the area of myocardium exposed to this interruption~     in blood supply, will largely become necrotic. The only way to limit final infarct size, is~     timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can~     also damage myocardial tissue and contribute to the final infarct size (reperfusion~     injury). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to~     ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma~     concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with~     adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical~     studies to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct~     size. Moreover, metformin therapy improves cardiovascular prognosis in patients with~     diabetes mellitus. Paradoxically, in patients with diabetes, current practice is to~     temporarily stop metformin before major surgery for the presumed risk of lactic acidosis,~     which is a rare complication of metformin. However, here is no evidence that this practice~     benefits the patient. The investigators hypothesize that pretreatment with metformin can~     reduce myocardial injury in patients undergoing elective CABG surgery~   "
123535|NCT01438710|"~     This study will evaluate and measure symptomatic hand tremor in stable kidney transplant~     subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion)~     and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro~     compared with Prograf or generic tacrolimus~   "
123536|NCT01438697|"~     This study will compare the efficacy of an interactive Internet intervention for adult~     insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website~     to improve sleep, mood related symptoms, perceived health status, and overall quality of~     life.~   "
123537|NCT01438684|"~     The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state~     patients. The assessment will be done using clinical measurements and functional MRI~     studies.~   "
123538|NCT01438671|"~     Our hypothesis is the investigators will find a significant advantage for the use of a~     virtual reality system like the Wii Fit to improve overall balance scores versus the use of~     traditional balance activities alone. The objectives will be to determine the enjoyment of~     these types of gaming activities through the use of a survey to support the hypothesis that~     these activities are more enjoyable than traditional activities and to gather evidence to~     support the use of these more enjoyable activities as a viable and needed addition to the~     overall balance regimen given in the plan of care for a patient with traumatic or acquired~     brain injury, stroke or spinal cord injury.~   "
123567|NCT01438294|"~     The purpose of this study is to assess the effects of a physical training program with~     active video game in inflammatory markers, quality of life variables , clinical control and~     physical and functional respiratory assessment of asthmatic children from 5 to 11 years.~   "
123539|NCT01438658|"~     Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment~     is effective, but patients still die of metastatic disease. It has been shown that early~     diagnosis of a few isolated metastases can result in a clean surgical excision of the~     metastases and an extension of the expected survival from 7-12 months to over 10 years on~     some patients.~      Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in~     the diagnosis of metastatic uveal melanoma.~      The investigators hypothesis is that a soluble serum biomarker level changes upon~     development of metastatic disease either by secretion by the tumor cells themselves or by~     their environment. Detection of changes in biomarker level may lead to the diagnosis of~     metastases before they can be detected by imaging modalities, thus allowing for early~     treatment of the metastases and a better chance of success.~   "
123540|NCT01438645|"~     Colonoscopy is an established technology that enables doctors to obtain live video from~     inside patients' large intestines, which is essential for the diagnosis of numerous~     intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and~     small video camera that transmits the images onto a display monitor. The doctor inserts the~     scope into the anus, moves it into the rectum and then guides it slowly through the entire~     colon. Because of the various twists and turns that are part of normal bowel anatomy,~     advancing the scope through the entire colon is not always successful and can become~     challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way~     for the doctor to see the shape of the scope inside the body other than what is seen from~     the video at its front end, and so navigating the colon relies on instinct accumulated with~     experience and the feel of the scope as loops begin to form. This is important because not~     only can this loop formation cause pain, but it can also increase the likelihood of an~     incomplete test. Incomplete tests matter because a major reason for performing colonoscopy~     is colon cancer screening and surveillance; detecting early cancers at treatable stages and~     looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance~     through the entire colon, parts are left unexamined where cancer may develop. A new~     technology called ScopeGuide has been developed that uses magnetic coils embedded within~     the scope to create a 3D image of the shape of the entire scope inside the body that is~     projected onto the monitor for the doctor to see. This will show if loops are forming and~     will provide information about how to eliminate loops once they have formed. In this~     research study, the investigators will compare colonoscopy with the assistance of ScopeGuide~     to colonoscopy performed in the standard fashion, to see if ScopeGuide results in more~     successful procedures that are easier for the doctor and more comfortable for patients.~   "
123541|NCT01438632|"~     A previous study showed that absorption and glucose-lowering action of rapid-acting insulin~     analogues occurred twice as fast when these analogues were administered by jet injection~     technology rather than by conventional insulin pen in healthy non-diabetic subjects. This~     study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with~     jet-injection or a conventional insulin pen prior to a standardised meal in patients with~     diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.~   "
123542|NCT01438619|"~     Epidemiological, clinical and animal-experimental evidence shows a direct relationship~     between dietary sodium intake, blood pressure and cardiovascular event. Diverse~     questionnaire and 24 hour urinary sodium measurement are used to estimate sodium intake.~     Complete reflection of eating and cooking habits to the dietary survey method is difficult.~     Furthermore, the differences of database between countries make it difficult to compare the~     amount of sodium intake between countries. It is also difficult to consider individual~     variation of cooking and eating habits. Due to limitations of dietary survey method, WHO~     recommended 24 hour urinary sodium measurement to estimated sodium intake in the population~     survey, and many countries are adopting. However, in Korea National Health and Nutrition~     Examination Survey, only dietary survey method has been used.~      The present survey study was designed 1) to test the feasibility of 24 hour urinary sodium~     measurement for the estimation of sodium intake (including percentage of complete 24 hour~     urine sample collection) in the population based study; 2) to establish feasible method of~     24 hour urinary sodium measurement; 3) to compare 24 hour urinary sodium measurement to the~     dietary survey method; and 4) to estimate the sodium intake by 24 hour urinary sodium~     measurement in Goyang city general population (aged 20-70 years).~   "
123543|NCT01438606|"~     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in~     HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine~     that participants can safely receive.~   "
123544|NCT01438593|"~     The purpose of the study is to determine the safety and possible effectiveness of brain~     transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.~   "
123545|NCT01438580|"~     Current guidelines recommend standard warfarin anticoagulation international normalized~     ratio (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The~     investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same~     effectiveness and better security in elderly patients (>75) with NVAF.~   "
123546|NCT01438567|"~     The primary research objective is to demonstrate that subjects taking OXN PR have~     improvement in symptoms of constipation as measured by the Bowel Function Index (BFI)~     compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain~     without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory~     (BPI).~   "
123547|NCT01438554|"~     The purpose of this study is to determine the safety and toxicity of the combination of~     pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated~     dose (MTD) of this combination for phase II study.~   "
123548|NCT01438541|"~     This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable~     subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular,~     surgical and orthopaedic medical care in the elderly admission, with a high risk to develop~     skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this~     investigation.~      The rational for this study is to evaluate the potential for Window in the prevention of~     pressure ulcers because of its ability to reduce shear and friction forces.~   "
123549|NCT01438528|"~     This is a Chinese, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
123568|NCT01438281|"~     The purpose of this study is to determine whether SYL1001 is safe for the prevention and~     treatment of ocular pain and dry eye syndrome.~   "
123722|NCT01436253|"~     This study is being done to see whether dietary and medicinal measures compliant with~     hyperlipidemia treatment guidelines will result in achieving target lipid values and to~     evaluate the total risk of cardiovascular disease in study participants who have not reached~     satisfactory lipid levels with their current hypolipemic therapy.~   "
123550|NCT01438515|"~     MRSA decolonization may reduce the risk of subsequent MRSA infection and further~     transmission. A recent randomized controlled trial demonstrated that systemic decolonization~     may be safe and effective among hospitalized patients when compared to no treatment. As a~     large number of the investigators patients require re-admission and further transmission may~     take place in the community, the investigators are comparing the standard decolonization~     protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory~     population.~      Standard decolonization protocols, which use only topical agents, are limited in efficacy.~     The method of systemic decolonization to be studied here appears to have greater efficacy~     than the standard approach using only topical agents. However, concerns have been raised~     that the increased use of systemic antibiotics may lead to increased levels of drug~     resistance adverse effects, without sustained decolonization. This study seeks to provide~     further data to help answer these questions and provide guidance for further policy~     development and implementation.~   "
123551|NCT01438502|"~     The purpose of this study is to verify that an infusion of hypertonic saline/colloids during~     cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with~     expected long-CPB-time.~      Expected beneficial effects are improved organ function for heart and lungs.~   "
123552|NCT01438489|"~     The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to~     placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus~     (SLE) with an inadequate response to standard of care treatment for SLE.~   "
123553|NCT01438476|"~     The goal of this clinical research study is to learn if there is a difference in patients'~     quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after~     surgery on the liver and/or pancreas. Researchers want to learn which method helps people to~     recover more completely and more quickly after surgery.~      The 2 kinds of pain control are intravenous (IV) pain management and epidural pain~     management.~   "
123554|NCT01438463|"~     The objective of the present study is to characterize the dose-response relationship of~     PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms~     of clinical efficacy and safety.~      For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due~     to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of~     treatment and at the end of the study patients will be subjected to a nasal provocation~     test.~   "
123555|NCT01438450|"~     Background Hepatocellular carcinoma, a malignant tumour of liver is one of the most common~     cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care~     hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in the~     investigators Gastroenterology out patient department. Most of these patients present late~     when the disease is already advanced and no curative therapies can be offered. At this~     stage, palliative therapy forms the mainstay of treatment. This includes transarterial~     chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of~     branches of portal vein, which further limit therapeutic options. According to Barcelona~     Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any~     standard form of therapy. These patients have been recommended for experimental therapies.~     Various forms of chemotherapy have been tried this group of patients. HCC is a vascular~     tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used~     in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of~     5-FU and has been used in patients with HCC and has been found to be safe.~   "
123556|NCT01438437|"~     The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and~     percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma~     (HCC) in patients of cirrhosis of liver.~   "
123557|NCT01438424|"~     The purpose of this study is to provide entecavir to participants who have completed another~     entecavir trial without achieving virologic response or who relapsed during postdosing~     follow-up.~   "
123558|NCT01438411|"~     The primary purpose of the study is to evaluate the therapeutic efficacy and safety of~     cholic acid in subjects with identified inborn errors of bile acid synthesis.~   "
123559|NCT01438398|"~     The purpose of this study is to learn about the safety and usefulness of a procedure called~     endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia.~     Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high~     pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such~     as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss.~      For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been~     the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy,~     the surgeon makes three to four small abdominal incisions, inserts tube-like instruments~     through them, and once inside, the junction between the esophagus and stomach is found, a~     lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter~     which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to~     open more easily. However, there is an emerging field known as natural orifice (opening)~     transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing~     an endoscope - a thin tube with a built-in camera, light and minuscule tools through the~     natural opening in the body, like the mouth in order to perform less invasive surgery~     without any external wounds or scars. The procedure is done using the Submucosal Endoscopy~     with Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth~     into the esophagus, where a small incision is made on the lining of the esophagus, known as~     the mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the~     inner lining of the esophagus and the outer wall consisting of the muscle of the esophagus.~     Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the~     endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision~     is then carefully made on the posterior portion of the muscular ring that forms the LES. The~     incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the~     easier passage of food while preserving some valve function to prevent reflux of acid from~     the stomach into the esophagus.~      The expected duration of participation is up to 10 years from the time study participants~     undergo the endoscopic surgical procedure.~   "
123560|NCT01438385|"~     Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ),~     Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year.~     Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or~     plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients~     suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal~     disorders. The investigators would like to assess prospectively the efficacy and safety of~     these routine procedures to permit identification of technical details about the procedures~     or other factors which might be associated with outcome or results. Assessment of these~     details would help us with problem identification and recommendations to improve health~     outcomes and quality of life in these patients.~   "
123561|NCT01438372|"~     The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose~     in comparison to oral ferrous sulfate in improving iron deficiency anemia in children with~     inflammatory bowel disease.~   "
123569|NCT01438268|"~     Specific Aim: To assess the quality of recovery of patients following early discharge (18~     hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed~     using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days~     (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed~     on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.~      Clinical Relevance: Postoperative recovery is a complex process related to various outcomes~     such as physiological endpoints, incidence of adverse events and change in psychological~     status. Previous studies of recovery after surgery and anesthesia have focused primarily on~     the physiological endpoints and the incidence of adverse events. Much of the work has~     occurred in specialties dealing with chronic disease states such as cancer, rheumatology and~     musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in~     the ambulatory population for postoperative recovery. Here the investigators propose to~     measure postoperative recovery outcomes within the first week following a TRAM flap~     reconstructive procedure using a validated postoperative quality of recovery instrument~     (QoR-27) and a 100 mm VAS for pain.~   "
123570|NCT01438255|"~     This is a prospective, non-comparative, open, observational study.~   "
123571|NCT01438242|"~     The purpose of this study is to examine the potential impact of the assay in terms of~     depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3~     months.~   "
123572|NCT01438229|"~     This is a prospective, multicenter, feasibility study on the safety and efficacy of renal~     denervation in patients with resistant hypertension.~   "
123573|NCT01438216|"~     The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive~     care patients.~   "
123574|NCT01438203|"~     The objective of this study is to investigate the comparative benefit of thrust and~     non-thrust manipulation on a population of patients with low back pain. The investigators~     hypothesize that there will be no difference in 4 week outcomes or greater, between the two~     groups.~   "
123575|NCT01438190|"~     Because many women with Polycystic Ovary Syndrome (PCOS) are very sensitive to the use of~     gonadotropins, several strategies have been proposed to reduce the risk of Ovarian~     hyperstimulation syndrome (OHSS) and multiple pregnancies.~      The low dose step-up protocol and the step-down protocols in PCOS patients have been~     described in literature.~      The step-down regimen is designed to achieve the follicle stimulating hormone (FSH)~     threshold through a loading dose of FSH with a subsequent stepwise reduction as soon as~     follicular development is observed on ultrasound. On the contrary the step-up regimen is~     based upon the principle of a stepwise increase in FSH supply to determine the FSH threshold~     for follicular development. After commencement of gonadotropin administration, if follicle~     development is not observed on ultrasound after 1 week, an increase in the dose is~     recommended. Once follicle growth is observed, the same FSH dose is maintained until~     follicular selection is achieved.~      Preliminary studies report that both step-up and step-down regimens achieve similar high~     rates of monofollicular development. However, the largest study published so far has shown~     that the step-up regimen is safer in terms of monofollicular development.~      Recent data demonstrate that metformin administration in infertile PCOS patients who are at~     high-risk for OHSS reduces the incidence and severity of OHSS during gonadotropin ovarian~     stimulation in a step-down regimen for in vitro fertilization (IVF) programs.~      The aim of the present study will be to compare the conventional low dose step-up protocol~     and the combined protocol consisting in metformin and gonadotropin step-down regimen.~   "
123576|NCT01438177|"~     This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together~     with chloroquine works in treating patients with relapsed or refractory multiple myeloma.~   "
123577|NCT01438164|"~     Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.~   "
123578|NCT01438151|"~     The purpose of this study is to improve the investigators understanding of the relationship~     between Crohn's disease and blood levels of the drug infliximab (Remicade). The~     investigators want to determine whether measuring drug levels can be helpful in~     understanding how patients respond to this treatment.~   "
123579|NCT01438138|"~     RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a~     patient's risk of relapse and plan better treatment for acute myeloid leukemia.~      PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how~     well it works in predicting risk of relapse in bone marrow cell samples from younger~     patients with acute myeloid leukemia.~   "
123580|NCT01438125|"~     The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a~     hydrogel scaffold, in improving scars and their resulting consequences following~     abdominoplasty or laparoscopy/laparotomy gynecologic procedures.~   "
123581|NCT01438112|"~     The use of a designed viral vector that can destroy cancer cells while leaving normal cells~     largely unharmed. The virus also stimulates an immunological response by producing a special~     factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It~     forms the hypothesis that this regimen may be used for people who have failed current forms~     of treatment and are recommended for cystectomy. It is with hope that this novel therapy~     will be able to delay or potentially avoid cystectomy for this patient population. Bladder~     instillation of this agent causes little long lasting side effects and may drastically~     improve the stimulation of the immune system for local cancer cell death as well as~     destroying those tumor cells that may have travelled to regional lymph nodes or distant~     organs.~   "
123582|NCT01438099|"~     This study wants to investigate if ultrasound assisted epidural catheter insertion for labor~     analgesia is easier and safer to the standard epidural technique.~   "
123583|NCT01438086|"~     When a patient has a heart attack, a blockage occurs in a coronary artery that delivers~     oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body~     naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the~     heart muscle cells from dying and may prevent heart failure or lessen the damage that~     occurs. IGF-1 is also available as a drug called mecasermin. In this study, heart attack~     patients will be given either a dose of mecasermin or a placebo (inactive treatment) after~     their coronary artery has been opened by a stent. The purpose of the study will be to~     evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart~     failure by evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight~     weeks after the heart attack.~   "
123584|NCT01438073|"~     The investigators are seeking subjects for a study of the role of kisspeptin in the~     reproductive system. Kisspeptin is a naturally occurring hormone in humans that stimulates~     the production of reproductive hormones. Continuous administration of kisspeptin~     paradoxically suppresses the reproductive endocrine axis temporarily. By administering~     24-hour infusions of kisspeptin, the investigators hope to learn more about the role of~     kisspeptin both in normal physiology and pathological conditions.~      The investigators are initially seeking healthy men, healthy women with regular menstrual~     cycles, and healthy postmenopausal women. In a later part of the study, the investigators~     will also enroll subjects with reproductive disorders. Study participation involves 2~     outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin~     and Gonadotropin releasing hormone (GnRH).~      Individuals interested in learning more may call 617-724-8592.~   "
123585|NCT01438060|"~     The primary objective of the study is to compare the efficacy of aripiprazole with placebo~     in patients with psychosis associated with Alzheimer's dementia.~   "
123586|NCT01438047|"~     This is a pilot exploratory study. The goal of this study is to evaluate a new imaging tool,~     optical frequency domain imaging (OFDI), to reveal the microvascular morphology of capillary~     malformations.~   "
123587|NCT01438034|"~     The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a~     diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two~     hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when~     subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin~     and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months~     until they reach 18 years of age to determine if their pubertal delay was self-resolved or~     permanent. Individuals interested in learning more may call 617-724-8592.~   "
123588|NCT01438021|"~     This pilot clinical trial studies continuous intraventricular methotrexate in treating~     patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving drugs directly into the ventricles may be an effective~     treatment for patients with leptomeningeal disease~   "
123589|NCT01438008|"~     Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests~     and injections. The investigators do not know if sugar also reduces pain in babies already~     receiving a continuous infusion of opioid analgesics. This project will help determine if~     small amounts of sugar water reduce pain in babies already receiving a continuous infusion~     of opioid analgesic during a heel lance procedure or nasogastric/orogastric (NG/OG) tube~     insertions. The investigators hypothesize that infants who are receiving opioid analgesics~     will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion,~     when sucrose is given, compared to when water is given.~   "
123590|NCT01437995|"~     This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group~     comparative effectiveness study of approaches to stepping down therapy for patients with~     well-controlled asthma treated with combination ICS and LABA.~   "
123591|NCT01437982|"~     The objective of this study is to identify any adverse events or adverse drug reactions~     through post-marketing surveillance under routine clinical practice~   "
123592|NCT01437969|"~     More than 1.5 millions individuals are infected with HCV in Italy. They are at risk to~     develop related morbidity and mortality from cirrhosis and hepatocellular carcinoma, unless~     the evolution of their disease is halted by treatment-induced HCV RNA clearance. Indeed, it~     is well recognized that a curative antiviral treatment, leading to HCV RNA undetectability~     24 weeks after the end of therapy, may prevent the occurrence of complications of HCV~     chronic liver disease.~      Several pre-treatment host and viral factors have been associated with the outcome of~     pegylated Interferon and Ribavirin treatment. These predictors are relevant as the ability~     to identify patients with the highest likelihood of achieving HCV RNA clearance may increase~     the number of patients who agree to be treated and who maintain their adherence to~     treatment.~      Several pre-treatment predictors as HCV genotype, HCV viral load, age, gender, body mass~     index, stage of fibrosis and race are very well recognized and have been used for many years~     during the treatment decision-making process. Based on studies of viral kinetics, HCV RNA~     undetectable at week 4 on treatment has been shown to represent the best on treatment~     predictor of response. In addition to these well known factors, very recently, a single~     nucleotide polymorphism (SNP) upstream of the gene IL28B on chromosome 19, coding for~     IFN-lambda 3 has been identified as associated with both spontaneous and treatment induced~     HCV RNA clearance.~      We have developed the molecular technique needed to evaluate this polymorphism in our~     laboratory. This technical process was a consequence of the genetics expertise of our~     research Institute. We have also performed a valuable comparison of the different methods to~     evaluate this polymorphism. Comparison of different technologies allow us to know the rate~     of variability between the different assays used.~      With this methodology we have evaluated a posteriori patients previously enrolled in~     Randomized Controlled Trial. The results of these studies confirmed the association between~     IL28B CC allele and a favorable outcome of HCV infection in our geographic area (Mangia et~     al Gastroenterology 2010; Mangia et al Hepatology 2010, AASLD presentation). We are now~     interested in prospective evaluation of patients referring to our center at the aim of~     understanding whether there are differences in the rates of IL28B frequencies in patients~     with different HCV genotypes.~      In fact, we hypothesize that the frequency of IL28B might be different according with~     different HCV genotypes and that this difference may explain the different rates of response~     to antiviral treatment reported in patients with HCV infection.~      Since we lead a collaborative group of hepatologists named AL-LIVER operating in Puglia,~     Lazio, Basilicata, Sicilia and Campania regions in Italy we would like to extend this~     evaluation to our collaborative group to explore in a large number of patients whether the~     prevalence of CC, CT and TT genotypes is inversely associated with HCV G1, 4, 3 and 2.~   "
123593|NCT01437956|"~     Serum KL-6 protein has been described as a biomarker of epithelial lung injury in~     Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial~     injury intensity has consequences on immediate and later respiratory prognosis. Furthermore,~     this prognosis seems to be different according to the respiratory causative virus. The~     investigators propose to study, during an epidemic season, the correlation between KL-6~     levels and clinical severity, and the type of viral infection.~   "
123594|NCT01437943|"~     The purpose of this study is to evaluate the effect of a short-term aliskiren treatment on~     kidney metabolism in patients at high risk for developing kidney dysfunction (i.e. kidney~     transplanted patients). The study is aimed at evaluating if any effect on kidney metabolism~     [using proton MR Spectroscopy(1H-MRS)] can be detected following a 6 months treatment with~     aliskiren regardless of its anti-hypertensive role. 1H-MRS can record a larger number of~     chemical species (up to 40) in the kidney, and monitor changes according to the pathologic~     state and health of the transplanted kidney.~   "
123595|NCT01437930|"~     The study was performed to investigate the effects of a daily consumption of n-3 PUFA~     supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk~     factors in hypertriglyceridemic patients.~   "
123596|NCT01437917|"~     The consumption of cereals-based foods with low glycemic indexes, high micronutrients and~     fibers contents are highly recommended. The target of this work is to provide new solutions~     for cereal based foods: the knowledge and understanding on the in vivo fate will be used to~     define structural features to gain in foods.~   "
123597|NCT01437904|"~     Outpatient tubeless Percutaneous nephrolithotomy (PCNL) could potentially improve patient~     care and result in significant cost savings for our hospital each year. If this pilot study~     is successful, Queen's/KGH will lead a collaborative national multicentre trial to further~     establish the role of this new approach in the surgical treatment of kidney stones.~   "
123598|NCT01437891|"~     An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and~     Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).~   "
123599|NCT01437878|"~     This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to~     evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary~     to COPD. The main objective is to investigate the effect of iloprost on exercise endurance~     time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety~     endpoints will additionally be analyzed.~   "
123600|NCT01437865|"~     The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared~     to current nodal staging methods.~      The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged~     nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will~     be regarded as the golden standard for nodal involvement.~   "
123635|NCT01437410|"~     The aim of this retrospective single center study was to evaluate the clinical utility of~     histological and immunohistochemical analyses of specimens obtained by endoscopic~     ultrasound-guided fine needle aspiration (EUS-FNA).~   "
123601|NCT01437852|"~     The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study~     evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting~     the healing of the deep partial-thickness component of complex skin defects. The proposed~     study population will include patients with 3-49% Total Body Surface Area (TBSA) complex~     skin defects including a deep partial-thickness component resulting from thermal injury. The~     study has been designed to focus on the evaluation of safety and tolerability of prolonged~     exposure to increasing amounts of a single application of StrataGraft skin tissue, while~     also assessing the potential for StrataGraft tissue to promote healing of the deep~     partial-thickness component of these complex skin defects as an alternative to donor site~     harvesting and autografting. Targeted enrollment for this study is up to 30 patients with~     complex skin defects due to thermal burns which require surgical excision and autografting.~     Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving~     StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third~     cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed~     in the operating room just prior to grafting.~   "
123602|NCT01437839|"~     To evaluate the effect of food on the pharmacokinetics of apixaban administered as~     commercial image tablets.~   "
123603|NCT01437826|"~     The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin~     A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large~     bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the~     incidence of metachronous adenomas was expected in patients allocated to the active~     compound (intervention) arm as compared to those assigned to a placebo.~   "
123604|NCT01437813|"~     Objective:~      The purpose of this study is to evaluate the effect of food intake in bioavailability (BA)~     of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy~     Mexican volunteers.~      Methods: A prospective, longitudinal, open label, non randomized study, was performed. A~     single oral dose of GLI/METXR (4/850 mg)was administered to 24 health Mexican volunteers 30~     min after a high fat meal. Blood samples were collected before the administration and 0.33,~     0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours~     post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma~     concentration of botk drugs were measured using high-performance liquid chromatography~     (HPLC). Plasma concentration time curves were plotted for each volunteers, and~     pharmacokinetic parameters (PK) were calculated. Adverse events were determined using~     clinical and laboratory test results throughout the study.~   "
123605|NCT01437800|"~     Objective:~      The purpose of this study is to evaluate the oral bioavailability of the combination~     Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers.~      Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24~     volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg). Blood samples~     were collected over 30 hours. Plasma concentration of both drugs were measured by using~     high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted~     for each volunteer, and pharmacokinetic parameters (PK) were calculated. Adverse events were~     determined using clinical and laboratory test results, throughout the study.~   "
123606|NCT01437787|"~     Primary Objective:~        -  To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503~          (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen~          volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan~          in patients with contraindications for MRI).~      Secondary Objectives:~        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.~        -  To evaluate the Overall Survival of patients treated with either 400 mg/day or 500~          mg/day of IMP as compared to placebo.~        -  To evaluate the Progression Free Survival of patients treated with either 400 mg/day or~          500 mg/day of IMP as compared to placebo.~        -  To evaluate the durability of splenic response.~        -  To evaluate the safety of IMP.~   "
123607|NCT01437774|"~     The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing~     thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial~     will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational~     treatment) or to treatment with a commercially available thrombectomy device It is expected~     that the investigational treatment safety profile in terms of clinically significant~     procedural adverse events will be comparable to the control group.~   "
123608|NCT01437761|"~     This study will compare how well blood of renal failure patients is cleaned with the new~     2008 Sorbent System using two different dialysate speeds.~   "
123609|NCT01437748|"~     -  The gold standard measures to evaluate small airways (SAW) in vivo is not well~          understood~        -  Two tests are today used to measure SAW but real results concordance is not clear~        -  These problems have a small evidence~        -  Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has~          never been studied~        -  Only an acute bronchodilators effect, after one hour of drugs inhalation, will be~          evaluated~        -  The time frame of study evaluations per patient will be of three hours: one hour for~          basal test; one hour rest after drug administration; one hour for post bronchodilators~          test~        -  All enrolled subjects will be outpatients and will be evaluated after 24 hours of~          inhalatory drugs washout~   "
123610|NCT01437735|"~     This study aims to demonstrate a clinically significant improvement in Forced Expiratory~     Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately~     controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an~     active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,~     multi-centre trial.~   "
123611|NCT01437722|"~     The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the~     prevention of recurrence of bacterial vaginosis.~   "
123636|NCT01437397|"~     The purpose of this Phase III study is to assess the maintenance bronchodilator effects of~     the fixed dose combination versus monotherapies. This study will also assess the effects of~     the fixed dose combination in terms of COPD symptoms, disease related health status and the~     long-term safety and tolerability of the fixed dose combination. This study will include a~     24 week treatment period, preceding by a run-in period, followed by a two week follow up~     visit. All patients will be randomized to one of four treatment arms or placebo.~   "
123612|NCT01437709|"~     This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of~     treatment are to control the lymphoma with the least amount of side effects. In many cases,~     MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced~     substance created to attach to proteins on the cancer cells, eventually destroying them.~     Chemotherapy is medicine that specifically destroys cancer cells.~      The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab~     and Bendamustine have on this type of cancer. Patients in this study will either receive~     Ofatumumab alone, or Ofatumumab combined with Bendamustine.~   "
123613|NCT01437696|"~     Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the~     skin (between April and October) or by a few foods such as fatty fish, eggs or fortified~     milk and margarine. This study has 3 main goals which are to determine if Veteran's have~     enough vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to~     correct low vitamin D stores and, if specially formulated foods using an approved vitamin D~     supplement, are appropriate to maintain vitamin D stores in relation with functional and~     cognitive status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks.~     After this period, the participants will be randomly separated into 3 groups (Group A, B or~     C) for a period of 24 weeks. Group A will receive their usual menu. Group B will receive~     their usual menu with 1 portion of food containing 500 IU of added vitamin D. Group C will~     receive their usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food~     intake will be assessed every 8 weeks and blood samples will be taken every 4 weeks to~     monitor change in blood concentration of vitamin D and other indicators of bone health. The~     investigators will document weight and height, hand grip strength, the mid-arm and mid-calf~     circumferences, the capacity to perform activities of daily living, the number of~     prescriptions and changes in health condition. The investigators will also take an X-ray the~     tibia and upper arm to document the amount and quality of bones in those regions. A total of~     60 veterans of Ste-Anne's Hospital will participate in this study. Knowing more about~     vitamin D status and intake will help in confirming the required vitamin D recommendations~     for the elderly men living in long-term care institutions.~   "
123614|NCT01437683|"~     The primary objective of the protocol is to study the long-term outcome of a large group of~     traumatic brain injury patients.~      This outcome is to be described in terms of activity, participation, quality of life,~     SOCIO-professional outcome and impact on caregivers, and in relation to health care~     provision.~      The secondary outcome is to measure the impact on functional outcome of several predictive~     factors, and their relative importance on outcome. Our principal hypothesis is that~     SOCIO-professional and health provision factors play a major role on long-term outcome,~     further even than initial severity of brain injury.~   "
123615|NCT01437670|"~     A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with~     solifenacin~   "
123616|NCT01437657|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive~     disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on~     study treatment is 6 weeks with a 3-week follow-up.~   "
123617|NCT01437644|"~     Cerebral palsy is common. It affects approximately 3 per 1000 children. Hip displacement due~     to muscle tightness (spasticity) occurs in up to half of the more severely affected~     children, and many of these children require major (bony) hip surgery. After bony hip~     surgery the management of pain is very difficult, as spasticity tends to increase and causes~     painful spasms which are difficult to control. Botulinum Toxin injections are known to~     reduce spasticity and therefore should also reduce pain. These injections take at least a~     week to work, but the effects can last for months. Botulinum Toxin is already an established~     treatment for chronic hip pain prior to surgery. The investigators aim to find out whether~     Botulinum Toxin injections can reduce post-operative pain. The identification of the level~     of pain can be challenging because most of these children are unable to communicate~     verbally. The investigators are therefore using a validated pain scoring tool that was~     designed especially for such children. This study will be the first to describe fully the~     pain experience of children with cerebral palsy undergoing this type of major surgery. The~     investigators will compare Botulinum Toxin injections with placebo (non-active) injections.~     There is a high emotional and financial burden on the families of these children. Families~     describe high levels of emotional distress around the time of surgery, particularly when~     their child is in pain. Difficulty with pain control post operatively may delay discharge~     from hospital and parental return to work. It causes disrupted sleep for the child and~     family and may delay the child's return to school. The results of this study will be shared~     with professionals and families at international conferences and in scientific and popular~     (patient-based) publications. This study cannot be undertaken in adults with cerebral palsy~     as they only rarely undergo this sort of surgery.~   "
123618|NCT01437631|"~     The aim of this study is to evaluate the efficacy of prophylactic clip application after~     colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate~     postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).~   "
123619|NCT01437618|"~     The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as~     first-line treatment could be considered a promising approach to improve the outcome of BRAF~     mutant metastatic colorectal cancer patients~   "
123620|NCT01437605|"~     The overall purpose of this research study is to find a better way to treat melanoma.~      The goals of this study are:~        1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 +~          AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC~        2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with~          or without the Poly IC:LC~        3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment~          with or without the Poly IC:LC~        4. To measure the rate of return of the patient's tumor in two groups of patients: one~          group positive for the gene signature, and the other group not positive for the gene~          signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly~          IC:LC.~   "
123621|NCT01437592|"~     This trial was conducted in Asia. The aim of this trial was to investigate the~     pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250~     (insulin degludec) in healthy Chinese subjects.~   "
123622|NCT01437579|"~     The etiology of bladder pain syndrome is unknown. Therefore the management is directed to~     pain relief, as bladder pain is believed to drive both voiding frequency and nocturia.~     Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy~     of botox for treatment of painful bladder.~      The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are~     suffering bladder pain syndrome with Hunner lesions during cystoscopy.~   "
123792|NCT01435343|"~     Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte~     colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory~     Acute Myeloblastic Leukemia (AML) aged 65 or younger.~   "
123623|NCT01437566|"~     This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase~     II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC)~     who have experienced recurrence or progression of their disease while receiving aromatase~     inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI~     therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have~     received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of~     this study. Part I of the study will assess the effect of the addition of GDC-0941 to~     fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival~     (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the~     safety and tolerability and to estimate the effect of GDC-0941 in combination with~     fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received~     prior treatment with an AI and whose tumors contain a PIK3CA mutation.~   "
123624|NCT01437553|"~     The iWONDER trial has the following objective:~      To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic~     plaques angiographically considered culprit and not-culprit in patients undergoing~     coronary angiography due to STEMI (ST-elevation myocardial infarction).~   "
123625|NCT01437540|"~     The purpose of this study is to assess the long-term safety and tolerability of inhaled~     aclidinium bromide/formoterol in patients with moderate to severe, stable chronic~     obstructive pulmonary disease (COPD).~   "
123626|NCT01437527|"~     The purpose of the study is to test a new procedure of body image therapy in anorexia~     nervosa, using the anamorphic micro software.~   "
123627|NCT01437514|"~     The local recurrence of rectal cancer is one of the main problem that fail the treatment.~     The preoperative neoadjuvant (chemo)radiotherapy has been confirmed to reduce the local~     recurrence rate,especially in the advanced rectal cancer. However the local recurrence rate~     is low about 10-20% totally,and the integrity of the mesorectum after the operation and~     circumferential resection margin(CRM) are the most critical factor for the local~     recurrence.So that, the advanced rectal cancer patients with negative CRM and had a complete~     mesorectum excision,may not benefit from the neoadjuvant radiation.This trial was mainly~     focus on the resectable advanced rectal cancer patients whose preoperative stage was cT3/N+.~     These patients will be divided into the lower risk group and higher risk group according the~     preoperative CT,Endoscopic ultrasound, and MRI,and carrying out randomized trial in the two~     groups respectively.The purpose of this trial is to confirm whether the preoperative~     radiotherapy is necessary for all the advanced rectal cancer patients,identify the reason of~     the local recurrence,and finally help the making of the treatment decision for the advanced~     resectable rectal cancer.~   "
123628|NCT01437501|"~     This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be~     conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships~     will be screened and three hundred eligible individuals will be enrolled in the study.~     Participants will be randomized into two treatment groups: one will receive a juice beverage~     containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,~     lime juice, and water and the other will receive a placebo beverage containing pineapple~     juice, lime juice and water. Participants will drink their assigned beverage every evening~     and provide biweekly urine samples and monthly blood samples. The principal endpoints of~     this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and~     their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels~     of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this~     population.~   "
123629|NCT01437488|"~     There is no accepted standard chemotherapy approved for use in the second line for patients~     with advanced urothelial carcinoma whose cancer has progressed on combination chemotherapy~     including either cisplatin or carboplatin. The chemotherapy class called taxanes, either as~     single agents or in combination, have demonstrated modest efficacy in small studies.~     Cabazitaxel is an agent in the taxane family designed to be active in the setting of~     acquired multi-drug resistance that arises in some tumors. The objective of this study is to~     evaluate the safety and efficacy of this agent in patients with urothelial carcinoma~     refractory compared to combination platinum based chemotherapy.~   "
123630|NCT01437475|"~     HBV vaccination is of paramount importance among HIV positive persons due to an increased~     risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a~     lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the~     normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more~     immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and~     more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive~     individuals.~   "
123631|NCT01437462|"~     The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not~     proven in a large-scale study. The researchers aim to provide an investigation that has~     sufficient power to clarify the potential effect of anaesthetic method on postoperative need~     of opioids. Sevoflurane and propofol will be compared.~   "
123632|NCT01437449|"~     Docetaxel and cetuximab are FDA approved for the treatment of squamous cell carcinoma of the~     head and neck. Cisplatin and carboplatin, while not FDA approved for Squamous Cell Carcinoma~     of the Head and Neck (SCCHN), have been used as standard of care in patients with SCCHN in~     combination with other drugs. This study will determine if weekly cisplatin and docetaxel,~     in combination with cetuximab, will be effective in palliative treatment of patients with~     squamous cell carcinoma of the head and neck. These drugs will be given intravenously~     weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable~     adverse events.~   "
123633|NCT01437436|"~     Obesity is associated with increased risk of surgical complications. Ventilation tube~     insertion is one of the most frequent surgical procedures performed on children. However,~     the impact of obesity on surgical results or surgical related complication following~     ventilation tube insertion remains poorly understood. The aim of this study was to~     investigate the effect of obesity on the surgical results of ventilation tube insertion for~     otitis media with effusion (OME) in pediatric patients.~   "
123634|NCT01437423|"~     The purpose of this study is to assess the safety of TETRAXIM™ administered in routine~     clinical practice according to Korea Food and Drug Administration Notification No. 2009-46~     Basic standard for reexamination of new drug based on the pharmaceutical law in Korea.~   "
123637|NCT01437384|"~     36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete~     the entire study. The study will consist of a pre-treatment phase and a treatment phase. The~     pre-treatment phase will include screening and baseline period 1. The treatment phase~     consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral~     dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose;~     Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 -~     concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will~     precede each treatment period. The screening period will be up to 13 days in duration. After~     fulfilling screening requirements, subjects will check into the clinic on Day -1 for~     baseline assessments. They will be domiciled in the clinical testing facility for 6 days for~     Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8~     outpatient visits. They will be domiciled in the clinical testing facility for at least 14~     days for Treatment Period 2 and will return intermittently for study procedures for 7~     outpatient visits.~   "
123638|NCT01437371|"~     The purpose of this study is to determine if there is an interest to optimize HF (heart~     failure) management in patients over 80 years old. The primary objective is to assess the~     effect of HF (heart failure) optimized management (guidelines of the European society of~     Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.~   "
123639|NCT01437358|"~     Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the~     intensive care unit settings, EA should be proposed in critically ill patients, such as~     postoperative or trauma patients, typically. Recent findings also support anti-inflammatory,~     vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA~     safety and feasibility in the intensive care unit settings are still lacking. The purpose of~     this observational prospective study is to describe the safety and feasibility of this~     analgesia technique in ICU patients.~   "
123640|NCT01437345|"~     This study is an observational study that aims to advance our knowledge on infantile onset~     FSHD. The study will include 50 participants of all ages who have presented with symptoms of~     FSHD between birth and 10 years of age. Study participation will involve a single day of~     assessments at one of the participating CINRG centers (to include physical exam, cognitive~     testing, eye exam, hearing test, strength testing and speech evaluations). The procedures~     may be split over additional days for scheduling purposes.~   "
123641|NCT01437332|"~     Specific proteins and other signaling molecules are increased and decreased following nerve~     injury. Some of these are important in producing pain or explaining why pain persists after~     traumatic nerve injuries or in disease states such as diabetes. In this study, the~     investigators hypothesize that it is possible to detect changes in specific signaling~     molecules and that these will provide insights into novel treatment strategies. The patients~     to be included are those who are undergoing the removal of tissue during surgery. The~     tissues that would otherwise be discarded will be included in the study as appropriate.~   "
123642|NCT01437319|"~     The purpose of this study is to determine if the formation of mucin balls is a marker for~     protection from inflammatory events to the cornea and if mucin balls play a role in~     protection during extended contact lens wear.~   "
123643|NCT01437306|"~     The objective of this single-dose, open-label, randomized, two-period, two-way crossover,~     food-effect study is to evaluate the effect of food on the rate of absorption and oral~     bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured~     by US WorldMeds, LLC.~   "
123644|NCT01437293|"~     An inpatient safety study to characterize the cardiovascular and behavioral effects of~     cocaine administration in the presence of LCE. The proposed study involves an inpatient stay~     of 12 days during which participants will have two cocaine-administration sessions, each~     including five doses of smoked cocaine with ascending doses.~   "
123645|NCT01437280|"~     Oncolytic viruses are viruses that can be found in nature, but they have been modified so~     that they can no longer multiply in normal cells. These viruses infect cancer cells and~     kill them. Once the cancer cell dies thousands of the viruses are released and can~     potentially infect other cancer cells in the area. The effects of oncolytic viruses on the~     tumor are felt to be the result of a combination of the oncolytic viruses directly killing~     the tumor cells as well as the patient's immune system killing cancer cells that are~     infected with the oncolytic virus.~      Modern oncolytic viruses have been used for treatment of thousands of patients. The safety~     of such treatments has been good and there have been no deaths caused by treatment with~     oncolytic viruses. Many patients have benefited from the treatment in the sense that their~     tumors have stopped growing, become smaller or even completely disappeared. Some benefits~     are temporary, but about one third of patients seem to gain longer lasting benefit likely to~     impact survival. The effect of oncolytic viruses on improving survival has not been~     demonstrated yet.~      Oncolytic viruses can be created from many different types of viruses. In this study the~     investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the~     types of viruses that cause the common cold and the flu. Because replication in normal cells~     does not take place, these oncolytic viruses should not cause any diseases in normal cells.~     Further, to date there has been no incidence of passing the virus on to other humans from~     patients who were treated with oncolytic viruses.~      The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being~     used in this study) that can safely be given to subjects. The investigators will also~     evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and~     improving patient survival.~   "
123646|NCT01437267|"~     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the~     Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid~     Fever is highly endemic and an efficacious vaccine against this disease is very much needed.~   "
123647|NCT01437254|"~     Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate~     [GPERT] scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to~     radioactive iodine therapy. The first 10 subjects will receive one CPTERT [cyclotron made]~     Tc-99m Pertechnetate scan after surgery. Vital signs and blood work, pre-injection and~     post-imaging will be done. The second group of 20 subjects (2 for each CPERT subject) will~     be matched as to age and gender and have a GPERT scan for qualitative comparison.~   "
123648|NCT01437241|"~     The purpose of this study is to evaluate the virological and clinical efficacy of etravirine~     plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected~     patients. Additionally, the safety of these regimens, specially lipid profiles, will be~     assessed.~   "
123695|NCT01436617|"~     The main objective of this study is to validate the utility of IgE anti-cetuximab in the~     treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab~     (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe~     reactions.~   "
123696|NCT01436604|"~     The main objective of this study is to compare the proportions of late enhancement in~     patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group~     consisting of patients who did not have LV dysfunction after 6 months under the same~     treatment.~   "
123649|NCT01437228|"~     Cesarean delivery rates are increasing in Turkey and a major component of this increase is~     cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a~     national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of~     endomyometritis and wound infection, remains a leading cause of postoperative complications.~     Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and~     obstetric variables. Infection following cesarean delivery results in not only increased~     hospital stay but also increases the cost of care. Strategies to minimize postoperative~     infectious and other morbidities have included modifications of surgical technique, changing~     of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and~     altering the uterine position during repair of the uterine incision. Despite these~     interventions, endometritis is still major problem after cesarean delivery.~      Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing~     an important role. The microbes endogenous to the vagina change throughout the course of~     pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the~     vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand,~     reaching below the infant's head or presenting part, is in direct contact with the vagina.~     Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95%~     confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal~     flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision.~     Vaginal preparation has been shown to decrease the quantitative load of vaginal~     microorganisms as well as to remove certain species of bacteria.~   "
123650|NCT01437215|"~     The purpose of this study is to determine whether the Endologix fenestrated stent graft~     system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic~     aneurysm.~   "
123651|NCT01437202|"~     This is a multicenter, retrospective, observational study to validate a pharmacogenetics~     model for imatinib metabolism and resistance in patients with chronic myeloid leukemia among~     patients in different independent cohort.~   "
123652|NCT01437189|"~     The aim of this open-label, self-control study is to evaluate the efficacy of sertraline in~     treating depression in Patients with Parkinson's disease. In addition, the investigators~     also want to find out whether patient gets better quality of life when depression is~     improved.~   "
123653|NCT01437176|"~     The purpose of this study is to determine whether this new intramedullary fixation is~     effective in the treatment of intertrochanteric fracture.~   "
123654|NCT01437163|"~     The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy~     system configured in a novel product called the TopHat 655 system, for promoting hair growth~     in males and females diagnosed with androgenetic alopecia of the head.~   "
123655|NCT01437150|"~     The purpose of this study is to determine whether this new anatomical locking plate is more~     effective and easy to operate than other plate in the treatment of acetabular posterior wall~     fracture.~   "
123656|NCT01437137|"~     Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children~     has been shown in several large observational studies, findings suggest that the~     smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance~     under general anesthesia in small infants and that they may even be associated with more~     frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is~     a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with~     a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy~     insertion, high airway leak pressures, and low complication rates with few postoperative~     complaints. The aim of this study is to compare clinical performance of the pediatric i-gel~     and c-LMA in infants.~   "
123657|NCT01437124|"~     The investigators aim to measure the blood levels of certain metals in a group of patients~     all of whom have had a ceramic on metal total hip replacement. This new bearing surface~     (joint) is relatively new and the investigators are currently following up the largest~     cohort in the world. Clinical results are currently excellent at 2 years in all patients,~     however the investigators are mindful of the lessons learned from the high failure rate of~     several designs of metal on metal hip replacements as well as several in vitro reports and~     one in vivo case report of elevated metal levels in this particular implant. The~     investigators feel it is important to measure the metal ion levels in our group to ascertain~     and compare these with reference standards. Once performed the investigators can relate ion~     levels to function and x ray changes and provide useful longterm data to the patients and~     the wider medical community as to whether this bearing surface is safe in the long term or~     whether it's use should be abandoned. This is useful as there are numerous groups implanting~     this device in the UK and in addition it has just been awarded FDA approval in the USA - its~     use is likely to flourish.~   "
123658|NCT01437111|"~     This study will assess the effect of 26 weeks of once-weekly treatment with~     MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus~     70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].~   "
123659|NCT01437098|"~     The primary objective of the present trial is to demonstrate the effectiveness and safety of~     the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed~     difficult for surgical operation.~   "
123660|NCT01437085|"~     Prostate brachytherapy is an effective treatment option for men with localized prostate~     cancer, with excellent cure rates and a favorable toxicity profile. With the current needle~     insertion technique, seed placement inaccuracy is primarily caused by needle deflection and~     soft tissue deformation, which both occur during the brachytherapy operation. This study~     will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of~     ultrasound images, video clips and one CT scan.~   "
123661|NCT01437072|"~     This study is conducted in the Middle East, Northern Africa and Europe. The aim of this~     study is to contribute to the design of a simple screening strategy for countries in scope,~     by exploring the association between risk factors and undiagnosed diabetes in a screening~     study.~   "
123662|NCT01437059|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol~     (LDL-C).~   "
123697|NCT01436591|"~     The primary endpoint of this study is to show that this algorithm in high definition is~     superior to the classical algorithm in the diagnosis of lymph node metastases.~   "
123663|NCT01437046|"~     Only three medications are approved by the Food and Drug Administration (FDA) for the~     treatment of alcohol dependence (AD), namely disulfiram, naltrexone tablets and injection,~     and acamprosate, however treatment success has been inconsistent. Thus, there exists a~     substantial need for discovering ways to provide more effective treatments. Pre-clinical and~     clinical evidence has clearly demonstrated that the noradrenergic (NE) system is involved in~     the neurobiology of AD, thus representing an interesting new pharmacotherapy target and the~     theoretical rationale for this proposal. Consistent with the concept that the NE system may~     represent a new pharmacological target for AD, recent studies have shown that the prototype~     alpha-1 NE receptor antagonist prazosin reduces alcohol drinking in different animal models.~     Furthermore, clinical evidence has also confirmed that prazosin appears to be efficacious in~     reducing alcohol consumption in alcohol-dependent individuals. While prazosin has a~     significant side effect profile and must be taken three times a day, no other α1-blockers~     have been investigated in alcohol research. Prazosin is a short-acting α1-blocker approved~     to treat hypertension (HTN) and benign prostatic hyperplasia (BPH). After the approval of~     prazosin in the 70's, other selective α1-blockers have been developed to treat HTN and/or~     BPH. Among them, doxazosin has shown a more manageable and safer profile than prazosin. In~     fact, doxazosin is a long-acting α1-blocker, thus it is taken only once/day. Doxazosin is~     also less likely to give hypotensive side-effects. Thus, doxazosin is more commonly used in~     clinical practice to treat HTN and/or BPH, than short-acting α1-blockers, such as prazosin.~     Poor adherence to medications and/or side-effects represent important factors limiting the~     effectiveness of pharmacotherapies for patients with AD. If effective for AD, doxazosin may~     represent a simple, manageable and safe medication, which might be more easily transferable~     to clinical practice. However, doxazosin has never been tested in AD. This project is a~     10-week, double-blind, placebo-controlled, between-subject randomized clinical trial with~     doxazosin (16mg once/day) in alcohol dependent (AD) individuals. This study attempts to~     address whether doxazosin is an effective and safe pharmacotherapy for AD.~   "
123664|NCT01437033|"~     Background:~      - Some types of cancer, like cancer of the esophagus, are difficult to detect at an early~     stage. A possible detection method involves collecting breath samples to look for chemicals~     that may be signs of cancer. However, more research is needed to determine how different~     chemicals appear in different breath samples. This study will involve healthy volunteers.~      Objectives:~      - To study chemicals appearing in breath samples of healthy volunteers.~      Eligibility:~      - Healthy volunteers between 30 and 60 years of age.~      Design:~        -  Participants will fast overnight (midnight to morning) and then provide two breath~          samples taken 5 minutes apart.~        -  Breath samples will be collected on days 1, 49, and 98 of the study~   "
123665|NCT01437020|"~     Background:~      - Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The~     parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also~     affect the blood and immune system. One possible treatment for VL involves an experimental~     drug called SCH708980, which may help to prevent the immune system from becoming suppressed~     and worsening the VL. Researchers want to give the drug along with AmBisome(Registered~     Trademark), which kills the parasites, to see if it is a safe and effective treatment.~      Objectives:~      - To study the safety and effectiveness of SCH708980, alone and combined with~     AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.~      Eligibility:~        -  Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in~          the past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30~          days.~        -  All participants will come from and be treated at the Kala-Azar Medical Research Center~          in Muzaffarpur, India.~      Design:~        -  This is a two-part study. Participants will be assigned to only one part of the study.~        -  Participants will be screened with a medical history and physical exam; blood, urine,~          and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray;~          and a heart function test.~        -  Part 1 participants will be separated into two groups: a larger group will have a~          selected dose of the study drug followed by AmBisome 7 days later, and a smaller group~          will have a placebo treatment followed by AmBisome.~        -  Part 2 participants will have either the study drug or a placebo plus AmBisome, based~          on the test results from the Part 1 participants.~        -  All participants will be monitored in the hospital for 30 days, and will have the~          following tests:~        -  Regular blood samples~        -  Urine and stool samples (day 14)~        -  Spleen measurements (days 8, 14, 21, and 30)~        -  Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms~          will give another sample on day 45.~        -  At 6 months after the start of treatment, participants will have a follow-up visit with~          spleen measurements, blood and stool samples, and possible spleen or bone marrow~          samples~   "
123666|NCT01437007|"~     Background:~      Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular~     cancer) or spread to the liver from cancers in other parts of the body (e.g. colon,~     pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the~     liver.) People who have tumors that can be removed by surgery live longer than those whose~     cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps~     people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be~     removed by surgery. However, most chemotherapy drugs do not work well on tumors in the~     liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer~     blood supply in the liver circulation, to see if it will cause tumors to shrink.~      Objectives:~      - To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not~     responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have inoperable cancer that has started in or~     spread to the liver.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests, and imaging studies.~        -  Participants will have a liver angiogram (type of X-ray study) to look at the blood~          flow in the liver and to place a catheter for delivery of the TKM080301.~        -  Participants will have a single dose of TKM-080301 given directly into the liver. After~          the drug has been given, the catheter will be removed. They will have frequent blood~          tests and keep a diary to record side effects.~        -  Participants may have two more doses, each dose given 2 weeks apart. {Before each dose,~          participants will have another angiogram and catheter placement.}They may also have~          liver biopsies to study the tumors.~        -  Two weeks after the third treatment (one full course), participants will have a~          physical exam, blood tests, and imaging studies. If the tumor is shrinking, they may~          have up to three more courses of the study drug.~        -  Participants will have follow up visits every 3 months for 2 years after the last~          course and then every 6 months as required.~   "
123667|NCT01436994|"~     The investigators aim to establish whether biochemical control during anti-thyroid drug~     therapy in young people with thyrotoxicosis varies depending upon whether a 'block and~     replace' or 'dose titration' regimen is used. The investigators will also assess remission~     rates and the frequency of side-effects in the two treatment groups.~   "
123668|NCT01436981|"~     The purpose of this study is to determine the pharmacokinetic of papaverine after~     administration into the artery mammaria interna.~   "
123669|NCT01436968|"~     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in~     combination with radiation therapy for patients with intermediate-high risk localized~     prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing~     tumor cells in an immune stimulatory environment induces the body's immune system to detect~     and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity~     and lower than expected recurrence rates in previous clinical trials. The hypothesis is that~     ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer.~     Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms~     receive standard external beam radiation therapy. Short-term androgen deprivation therapy~     may be given but is not required.~   "
123670|NCT01436955|"~     This multi-center, randomized double-blind, placebo-controlled study will assess the safety~     and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be~     randomized in cohorts to receive either multiple oral doses of RG1662 or placebo.~     Anticipated time on study treatment is 38 days.~   "
123698|NCT01436578|"~     This study will examine the safety and efficacy of posaconazole in general use in Korea.~      Post-marketing surveys are not considered applicable clinical trials and thus the results of~     this survey will not be posted at its conclusion. The results will be submitted to public~     health officials as required by applicable national and international laws.~   "
123723|NCT01436240|"~     The purpose of this study is to see if questions in English about symptoms that patients may~     have during cancer treatment are understandable when translated into Spanish. These~     questions will later be used in future studies to give a better understanding of patient~     symptoms.~   "
123671|NCT01436942|"~     Background:~      Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together~     with medication. Last years, increased risk of cardiovascular diseases in patient with~     inflammatory diseases is reported, probably caused by inflammation and increased prevalence~     of traditional risk factors. In both healthy adults and other patient groups,~     cardiorespiratory and muscular strength exercises have been shown to have a positive effect~     on inflammation as well as on cardiovascular risk factors. To our knowledge this has not~     been shown in patients with ankylosing spondylitis.~      Objective: The aim of this study is to investigate the effects of a cardiorespiratory and~     muscular strength exercise program on disease activity and cardiovascular risk factors in~     patients with ankylosing spondylitis~   "
123672|NCT01436929|"~     Tuberculosis is a worldwide common infectious disease and effective first line~     anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and~     pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation~     of anti-TB drugs or changing anti-Tb drug regimen.~      Silymarin has been widely studied for the effect on hepatitis and it has been used in~     hepatology.~      Therefore, the investigators hypothesized that prophylactic administration of silymarin with~     anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB~     drugs.~   "
123673|NCT01436916|"~     Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D~     deficiency is also high i.e. 78-96% in different groups of population in north India.~     Observational studies find association between low Vitamin D status and type 2 diabetes~     mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year~     .There is mechanistic support that vitamin D may influence both insulin secretion and~     insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and~     prospective studies support the role of vitamin D in the prevention of T2DM. This study will~     be a single blind randomized placebo controlled trial to study the effect of oral~     cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also~     vitamin D insufficient.~   "
123674|NCT01436903|"~     CavatermTM is a second-generation thermal balloon ablation device in the management of~     menorrhagia. The purpose of this study is to investigate the success (questionnaire) of~     CavatermTM dependent on uterus probe length, especially corpus probe length, which is~     measured during surgery.~   "
123675|NCT01436890|"~     Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported~     prevalence in most industrialized countries of between 5 to 10 % of the adult population.~     Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest~     tightness, and coughing; usually in the presence of variable airflow obstruction that is~     often reversible either spontaneously or with treatment (The Global Initiative for Asthma~     (GINA), 2009).~      Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest,~     intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in~     asthma, but chronic use of these agents may be associated with a range of side effects,~     especially at high doses. In asthma, there remains a need for the development of novel~     anti-inflammatory therapies that are at least equally effective and possess a superior~     safety profile in comparison to corticosteroids.~      This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose~     ranging study. The study will be conducted in adult patients with a diagnosis of chronic~     persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the~     predicted value. Study will enroll 448 patients globally (278 from India) across different~     centers.~      Patients will be recruited after providing written informed consent. After screening and run~     in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1~     ratio to receive either one of the three dose regimens of revamilast or placebo.~      The primary objective of the study is to evaluate the effect of revamilast on lung function~     as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks).~     Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient /~     investigator's global assessments and safety. Patients will be followed for safety and~     efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.~   "
123676|NCT01436877|"~     The purpose of this study is to assess the safety and efficacy of MediTate Temporary~     Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction~     (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder~     neck and prostatic urethra under local anesthesia for few days and taken out some 5 days~     later in the doctors office.~   "
123677|NCT01436864|"~     This study is designed to prove and confirm the efficacy and safety of multiple injections~     of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902)~     in patients with choroidal neovascularization due to neovascular age-related macular~     degeneration by comparing intravitreal injections of KH902 with sham-injections.~   "
123678|NCT01436851|"~     In a previous study the investigators found that many bakery workers were sensitized to~     storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational~     allergen with clinical relevance has been questioned, and the investigators wanted to~     investigate whether a nasal provocation with a storage mite extract would trigger symptoms~     and objective signs of rhinitis in bakery workers and a control group.~   "
123679|NCT01436838|"~     Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy~     thereby involving safety risks for the patient and influencing health cost-effectiveness.~     This observational study will concentrate upon the role of MS nurses in influencing~     adherence. This study will examine the influence of initial and subsequent periodic nurse~     interviews which aim to improve adherence to Betaferon® treatment.~   "
123680|NCT01436825|"~     OPTIMS is a non interventional validation study of the calculator developed by Bayer for~     clinician's use in the prophylactic treatment by factor VIII of patients with severe or~     moderate Haemophilia A with a severe clinical profile.~      The study takes place during a single visit, at the time of patient enrollment in the study~   "
123681|NCT01436812|"~     The investigators hypothesized that positive end expiratory pressure (PEEP) would increase~     the regional oxygen saturation (rSO2).~   "
123682|NCT01436799|"~     The investigators hypothesized that both propofol and desflurane would decrease the regional~     oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when~     patients are raised to the sitting position.~   "
123683|NCT01436786|"~     Demonstrating the effectiveness of an economical and feasible intervention such as guided~     imagery on factors associated with preterm birth, along with better understanding of~     pathways leading to adverse birth outcomes has tremendous health, social, and financial~     benefits. This project has the potential to significantly advance the field of nursing and~     knowledge development in the areas of maternal stress reduction in African American women~     and to provide scientific evidence of the effectiveness of guided imagery.~   "
123793|NCT01435330|"~     The study will assess the safety, tolerability, drug label and effect in subjects with and~     without insulin resistance.~   "
123684|NCT01436773|"~     Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated~     with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated~     as a technique to measure the density of VV. Previous studies have demonstrated a~     relationship between identification of VV and relationship to vascular events such as stroke~     and myocardial infarction. No previous study has reported the utilization of~     contrast-enhanced ultrasound identification of VV in the carotid bed as a means of~     identifying patients at high risk for acute coronary events.~      Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels~     along with carotid intima media thickness (CIMT), a known marker for acute coronary events.~     The investigators will attempt to measure the correlation of VV with acute coronary events~     independent of traditional cardiovascular disease (CVD) risk factors and CIMT.~      Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery~     disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled.~     All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and~     measurement of CIMT while obtaining baseline histories and assessment of traditional risk~     factors for coronary artery disease. VV density and CIMT will be measured in all patients.~     Statistical differences in VV among the three groups will be assessed and analyses will be~     made to attempt to identify if VV in the carotid bed is an independent predictor of acute~     coronary events after controlling for CIMT and traditional risk factors.~      Study population: The study population will reflect the patient population of UPMC. No~     individual will be excluded on the basis of race, gender, or ethnicity.~   "
123685|NCT01436760|"~     The goal of the study is to identify possible polymorphisms on the loci of candidate genes~     that may be involved in modulation of pain and inflammation in irritable bowel syndrome.~   "
123686|NCT01436747|"~     The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney~     Transplant Recipients' is designed to assess the effects of paricalcitol in kidney~     transplant recipients with proteinuria.~      It is a single centre, randomized, placebo-controlled, double-blind clinical trial that~     tests the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will~     result in a decrease in urinary protein excretion in recipients of a kidney transplant at~     least three months after transplantation. Additionally, the effects of paricalcitol on~     albuminuria, estimated glomerular filtration rate, and blood pressure will be investigated.~   "
123687|NCT01436734|"~     The aim of the study was to investigate the role of the Trasylol in glucagon prevention in~     degradation using radioimmunoactive method with I125. Additionally different incubation time~     was introduced in human plasma samples after oral glucose stimulation, also in fasted and~     hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the~     techniques for the glucagon measurement are well described nowadays.~   "
123688|NCT01436721|"~     Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The~     mortality and morbidity rates after hepatectomy have declined in recent years because of the~     precise measurement of liver functional reserve, a better understanding of liver anatomy,~     meticulous haemostasis during operation and improved postoperative management. Although~     surgical techniques have improved, life-threatening complications, such as intra-abdominal~     bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local~     complications were most associated with the liver section treatment during the operation.~     Hence, the need for safer and more effective hemostatic treatment than the conventional~     approaches, such as intraoperative pressure by surgical gauze, ligatures, and~     electrocoagulation by mono- or bipolar instruments.~      Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the~     controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with~     blood, it swells into a brownish or black gelatinous mass which aids in the formation of a~     clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers~     on section.~      The present randomized clinical trial was designed to evaluate the efficacy and safety of~     Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.~   "
123689|NCT01436708|"~     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual~     dysfunction, and analyzing the association will be helpful to identify the indication of~     proper management. Therefore, the aim of this study is to identify the above associations.~   "
123690|NCT01436695|"~     Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly~     unpredictable spontaneous seizures. The occurrence of the seizure in patients without any~     forewarning is the most debilitating aspect of the disease.~      The Epicall system is intended for early detection of seizure related life threatening~     events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the~     side of the face. The external sticker incorporates EOG (electrooculograph electrode) and~     PPG (photoplethysmograph electrode) sensors for continuous monitoring of:~        1. Heart Rate (base line, increase, decrease, asystole).~        2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).~   "
123691|NCT01436682|"~     The study investigates assisted nerve blocks using an ultrasound machine.~   "
123692|NCT01436656|"~     CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose~     (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice~     daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or~     metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and~     expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600~     mutation (during the expansion phase) will be enrolled. The study consists of a dose~     escalation part were cohorts of patients will receive escalating oral doses of LGX818,~     followed by a safety dose expansion part were patients will be treated with oral dose of~     LGX818 given at the MTD or RP2D.~   "
123693|NCT01436643|"~     This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple~     Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin~     reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI)~     antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate~     the safety and tolerability of this combination in this patient population based on an~     immunomodulatory treatment with fingolimod.~   "
123694|NCT01436630|"~     The purpose of this study is to investigate the viability of using the Step Test (ST) in~     stroke patients, and to compare the functional performance of the physiologic variables in~     stroke patients during ST and Six Minute Walk Test (6MWT).~   "
123699|NCT01436565|"~     Primary Objective:~        -  To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of~          SAR245408 administered in combination with SAR256212 in adult patients with locally~          advanced or metastatic solid tumors.~      Secondary Objectives:~        -  To characterize the global safety profile of SAR245408 in combination with SAR256212~        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in~          combination~        -  To evaluate the objective response rate (ORR) and tumor volume change (for expansion~          cohort only)~        -  To determine the immunogenicity of SAR256212 as administered with SAR245408~   "
123700|NCT01436552|"~     Background: Dementias (Alzheimer's disease and related syndromes), in their sporadic form,~     have multifactorial origin. Several risk factors (RF) are currently recognized like the~     cardiovascular RF, some genes of susceptibility, but the impact [1] of traumatic life events~     (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of~     anxiety and/or depression, [3] of the premorbid personality (Clément et al, 2003) with his~     coping strategies, and [4] of the lifestyle (which results from the personality), for the~     moment are still underestimated. Dementia disease can be clinically preceded by a mild~     cognitive impairment (MCI) (Petersen et al, 1996) which is however potentially reversible.~      Purpose: Actually, there is no study concerning the rate of conversion from MCI to dementia~     according to the presence or not of TLE. The aim of this study is to assess association~     between TLE and conversion rate from MCI to dementia.~      Methods: Patients with MCI will be recruited in different memory clinics (Limoges and~     others) Primary outcome: Occurrence of dementia according to DSM-IV-TR criteria in MCI~     patients according to their cumulated score of TLE measured by EVVIE.~      Secondary outcomes: Occurrence of dementia in MCI patients according to various other~     psychopathological factors: anxiety, depression, apathy, personality features, alexithymia~     and resilience levels and life style.~      Study design: Epidemiologic cohort longitudinal and prospective multicenter study.~   "
123701|NCT01436539|"~     The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus~     polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic~     hepatitis B.~   "
123702|NCT01436526|"~     The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant~     for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary~     embolism (PE) in people undergoing knee or hip replacement surgery.~      The purpose of this study is to establish bioequivalence of 2 immediate-release tablet~     treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy~     volunteers under fasting conditions; they will be administered as single oral doses in 2~     periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence~     represents the primary study objective. As a secondary objective, this treatment will be~     assessed in terms of safety and tolerability.~      Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood~     samples of the volunteers will be taken at specific points in time; these samples will be~     analyzed using various statistical methods to establish pharmacokinetic characteristics~     required to compare the 2 treatments. The planned treatments with Rivaroxaban will be~     considered bioequivalent if specific criteria defined in the study protocol are met.~      The study will be conducted in one center in Germany. 28 subjects meeting the inclusion~     criteria will participate. They will be treated according to a single-dose, randomized,~     2-way cross-over, non-placebo-controlled design.~   "
123703|NCT01436513|"~     The purpose of this study is to assess the bioequivalence and food effect for a new Premarin~     formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal~     women.~   "
123704|NCT01436500|"~     A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult~     patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.~   "
123705|NCT01436487|"~     A study to examine the safety and potential effectiveness of the adult stem cell~     investigational product, MultiStem, in adults who have suffered an ischemic stroke. The~     hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.~   "
123706|NCT01436474|"~     The objective of this proposal is to explore the potential of varenicline as a~     pharmacotherapeutic agent for opioid dependence and addiction.~   "
123707|NCT01436448|"~     Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus~     Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of~     the study is to determine the feasibility, compliance and safety of Lactobacillus Rhamnosus~     among this cohort. Within this goal is to determine whether the investigators can enroll~     women at high risk for developing Gestational Diabetes Mellitus (GDM) and follow them out at~     regular antenatal visits and 6-weeks post partum.~      Women with GDM are, 7 times more at risk of developing type 2 diabetes compared with those~     who had a normo- glycaemic pregnancy. The population attributable risk for type 2 diabetes~     mellitus (DM) in women with GDM is high, and around 30 - 50% women with GDM converts into~     type 2 (DM) which is associated with pre-mature morbidity, mortality and high economic~     burden. It is evident that untreated GDM is associated with higher incidence of~     complications during pregnancy and increases the risk of perinatal mortality and infant~     morbidity. The prevalence of GDM in Pakistan is around 8%, comparatively higher than other~     South Asian countries. Therefore, interventions that can improve glucose regulation during~     pregnancy are highly important.~      Probiotics, the live micro-organisms, have shown promising results in regulating glucose~     metabolism among pregnant mice. The effect of Probiotics on glucose metabolism is~     attributable to their immuno-regulatory properties. They elicit powerful anti-inflammatory~     capabilities by inhibiting the NF-kB pathway, which mediates microbial activation of the~     immune system. Further, they diminish both fermentation of polysaccharides and induction of~     fasting-induced adipocyte factor gene transcription. The safety of Lactobacillus Rhamnosus~     among pregnant women is already established in other diseases.~      A placebo controlled trial from Finland on pregnant females randomized to receive either~     dietary counseling and Probiotics (Lactobacillus Rhamnosus), concluded improved glucose~     tolerance as compared to the placebo group [OR 0.31 (95% CI 0.12, 0.78)]. However, this~     study could not determine the sole effects of probiotics in reducing glucose intolerance.~     Nevertheless, no studies on the role of Lactobacillus Rhamnosus in regulating glucose~     intolerance have been conducted in any other part of the world yet. Therefore, a pilot trial~     to see the efficacy, compliance and feasibility of Lactobacillus Rhamnosus among pregnant~     females is imperative. The objectives of the investigators study are:~        -  To assess the efficacy of Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units~          (CFU)/day) in reducing glucose intolerance among pregnant women attending antenatal~          clinic of Karachi-Pakistan.~        -  To assess the feasibility, compliance and safety of conducting a double blind, placebo~          controlled randomized trial of Lactobacillus Rhamnosus by recruiting high risk women~          during pregnancy attending antenatal clinics and following them up 6 weeks postpartum~          in Karachi-Pakistan.~      Methods: For the pilot trial, women will be recruited from antenatal hospital of the city,~     during 12-14 weeks of gestation.~      Study Design: The study will be double blind randomized, placebo controlled trial.~     Randomization will be done by blocked method. The dose of 1010 Colony forming Units (CFU)~     once daily till delivery will be given orally.~      Study Endpoints and Ascertainment: Baseline information will be comprised of socioeconomic~     status, parity, gravida, blood pressure and obstetric history etc. The study endpoint~     comprises of efficacy, feasibility, compliance and safety and will be ascertained at monthly~     follow-up, during week 24 - 28, and 6 weeks post partum. Efficacy will be ascertained by~     Oral Glucose Tolerance Test (OGTT) performed at randomization and during 24-28 weeks of~     gestation. Feasibility and compliance will be assessed through recruitment rate, drop-out~     rate, reasons for drop-out, non-participation and empty drug sachet count.~   "
123708|NCT01436435|"~     The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on~     various lesions types/morphologies.~   "
123709|NCT01436422|"~     Dengue viruses can cause dengue fever and other serious health conditions, primarily~     affecting people living in tropical regions of the world. This study will evaluate the~     safety and immune responses to two formulations of a tetravalent dengue virus vaccine in~     healthy adults.~   "
123710|NCT01436409|"~     The main objective of this study is to compare the rate of fetal extractions between a~     systematic practice of an echography of presentation and the vaginal touch only one usually~     realized during the labor.~   "
123711|NCT01436396|"~     The study is designed to evaluate whether the first CYD dengue vaccination can be~     administered concomitantly with Stamaril® yellow fever vaccine during the same day and~     visit, but at 2 different sites of administration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the immune response against Yellow Fever in~          flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine~          administered concomitantly with the first dose of CYD dengue vaccine compared to~          subjects receiving one dose of Stamaril vaccine concomitantly with placebo.~      Secondary Objectives:~        -  To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril~          vaccination based on seroconversion rates regardless of the FV status of subjects at~          baseline.~        -  To describe the safety of Stamaril vaccine administered concomitantly with the first~          dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.~        -  To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine~          administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.~   "
123712|NCT01436383|"~     The trial investigates changes in metabolism during high altitude expedition up to 6865m. A~     mass-spectrometry based platform is used to detect different oxidative stress related~     metabolites. Symptoms of acute mountain sickness are evaluated and correlated with~     laboratory parameters.~   "
123713|NCT01436370|"~     A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving~     TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched~     control subjects . This study will investigate the immunogenicity, safety, and~     reactogenicity of two different doses of inactivated trivalent influenza virus vaccine~     (Sanofi Pasteur Fluzone [15 mcg x 3 strains] and Sanofi Pasteur Fluzone High Dose [60 mcg x~     3 strains]) administered intramuscularly in individuals with rheumatoid arthritis receiving~     anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.~   "
123714|NCT01436357|"~     A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C~     virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1~     and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned~     interim analysis of safety and immunogenicity will be conducted. If no safety signal is~     detected and there is evidence of a measurable immune response to HCV then 472 (+/-4)~     volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of~     AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and~     2) determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV~     infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63~     months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended~     observation for subjects becoming viremic in the last month of follow-up).~   "
123715|NCT01436344|"~     With the use of esophageal Holter electrocardiography (eECG), the investigators will look~     for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will~     record eECGs in patients with known paroxysmal atrial fibrillation but at the time of~     eECG-recording in sinus rhythm. To identify markers, the eECGs of those patients will be~     compared to a group of controls in sinus rhythm without atrial fibrillation. The~     investigators hypothesis is that it is possible to identify surrogate markers in patients~     with paroxysmal atrial fibrillation.~   "
123716|NCT01436331|"~     Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly~     been conducted on non epidemiologically representative samples in experimental settings,~     raising the risk thereby of underestimating the complexities involved in treating onset~     psychosis in real world services. The PIANO Trial (Psychosis early Intervention and~     Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics,~     Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test,~     at 9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component~     psychosocial intervention on a large epidemiologically-based cohort of FEP patients and~     their family members recruited from a 10 million inhabitant catchment area; 2) identify~     barriers that may hinder its feasibility and patient/family conditions that can render this~     type of treatment ineffective or inappropriate; 3) identify clinical, psychological, and~     environmental and service predictors of treatment effectiveness in FEP.~      Study participants will be recruited from Community Mental Health Centers (CMHCs) operating~     for the Italian National Health Service and located in several Northern and Central Regions~     of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which~     is considered the gold standard approach for trials that evaluate complex interventions~     implemented at the institutional level, with the aim of improving health. The assignment~     units (clusters) are the CMHCs, and the units of observation and analysis are the Centers'~     patients and their family members.~      Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy~     (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager,~     to serve as the patient's referent. Patient enrollment will take place over a 1 year~     interval, after a 3 month-long piloting. The fidelity of the experimental interventions and~     the characteristics of TAU will be regularly monitored. Several psychopathological,~     psychological, functioning and service use variables will be assessed at baseline and 9~     month follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000~     per year for functional psychoses (as previously estimated in Italy), the investigators~     expect to recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about~     50%, the size of the trial would detect at 9 months a difference in terms of primary outcome~     from 25% for the TAU arm to 10% for the intervention arm, with a power of 80%.~   "
123717|NCT01436318|"~     Respiratory muscle strength training (RMST) is a potential treatment option that has been~     shown to increase strength and ventilatory function in critically ill patients, patients on~     ventilators and patients with mild neuromuscular weakness. Currently researchers are~     examining the role of inspiratory muscle strength training (IMST) in pressure performance of~     ventilator dependent children with Pompe disease. However, normal pressure-flow-timing~     responses of lung function are not well-characterized in healthy children. The purpose of~     this study is to measure RMST-induced changes in respiratory function in healthy children.~     Children will undergo one session of lung function and strength testing. By studying healthy~     children's respiratory function, this study will also help to develop more efficient~     respiratory muscle training exercise prescriptions for children with neuromuscular weakness~     and impaired respiratory function.~   "
123718|NCT01436305|"~     The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would~     minimize serious long term side effects associated with anti-rejection medications while~     still protecting the new kidney from damage. The researchers also wanted to learn more about~     the safety of this treatment and long term health of the transplanted kidney.~   "
123719|NCT01436292|"~     The purpose of this study is to determine whether 5% human albumin solution, given to~     correct hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a~     change in the SOFA score from baseline to day 7 (or before if the patient is discharged from~     the ICU or died).~   "
123720|NCT01436279|"~     In this study the investigators plan to compare mifepristone and misoprostol use to osmotic~     dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be~     given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2~     hours prior to abortion. Osmotic dilators are the method currently used in our institution,~     and are placed 24 hours prior to abortion. The primary outcome will be the length of the~     procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,~     participant's assessment of discomfort after mifepristone or dilators, discomfort during the~     abortion procedure, acceptability to participants, and acceptability to staff.~   "
123721|NCT01436266|"~     Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to~     aid in softening the cervix as well as decreasing blood loss after abortion or vaginal~     delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in~     decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled~     trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester~     surgical abortion decreases blood loss from the procedure. The investigators will also~     assess whether misoprostol improves cervical dilation, changes the length of the procedure,~     changes the need for additional mechanical dilation, changes the subjective ease of the~     procedure, and changes a woman's pain.~   "
123724|NCT01436227|"~     The goal of this clinical research study is to learn if pazopanib can help to control VHL.~     The safety of this drug will also be studied.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~   "
123725|NCT01436214|"~     This study is a phase 1/2a, open label, dose escalation and safety study of APC-100~     (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.~   "
123726|NCT01436201|"~     The purpose of this study is to study how the body processes digoxin and the effect of~     dulaglutide on how digoxin is processed by the body. Information about any side effects that~     may occur will also be collected.~      This study is for research purposes only and is not intended to treat any medical condition.~     This research study requires that a blood sample be obtained and stored for future research~     involving genetic analysis.~   "
123727|NCT01436188|"~     The purpose of this study is to investigate changes of cerebral spinal fluid (CSF) proteins~     over time using continuous CSF sampling for 36 hours in elderly healthy volunteers and~     volunteers with mild cognitive impairment or Alzheimer's Disease.~   "
123728|NCT01436175|"~     This study is an optional continuation of previous short-term adult major depressive~     disorder (MDD) augmentation studies. Patients may only take part in this long-term,~     open-label research study if they completed a previous double-blind MDD augmentation study~     using SPD489.~   "
123729|NCT01436162|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. Eligible patients will remain on their antidepressant but will be randomized to~     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study~     is to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can supplemental SPD489 help patients who still have residual depression symptoms while~          taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
123730|NCT01436149|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. Eligible patients will remain on their antidepressant but will be randomized to~     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study~     is to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can supplemental SPD489 help patients who still have residual depression symptoms while~          taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
123731|NCT01436136|"~     This is a cohort study which follows two groups of participants over a 12 months period. One~     group will access a team approach to care with the aim of reducing their cardiovascular~     disease (CVD) risks from a team of doctors, nurses and health care professionals. The other~     group will continue to access standard care from their treating doctor. Both groups will~     have CVD risk score evaluated after a 12 month period.~      The team care approach will involve specific tests to measure CVD risk as well as smoking~     cessation, exercise and dietary advice and support, including monitoring such as blood~     pressure and cholesterol levels~   "
123732|NCT01436123|"~     Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma~     volume (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and~     NANOM First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3~     respectively with high level of safety and feasibility.~      The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62)~     assessed (NCT01436123) the safety and feasibility of the delivery technique for~     nanoparticles (NP) using micro-injection catheter (with intravascular intramural injection~     of allogeneous stem cells carrying NP after MSCT-, IVUS- and OCT-guided mapping of the~     vessel), and plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano~     group, n=32) versus stenting with Xience V cage (Stenting group, n=30). The primary outcome~     was TAV at 12 months.~      The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min~     -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between~     groups). 42/62 patients (68%) in Nano group passed the Glagov threshold of a 40% plaque~     burden with mean plaque burden (PB) 36.2% (95% CI: SD 9.3%, min 30.9%, max 44.5%). The~     increase of the minimal lumen diameter was 61.2 and 63.3% at 12 month follow up in groups~     respectively. The serial assessment of VH-IVUS showed a significant decrease at 12 months in~     the dense calcium area, fibrous and fibro-fatty tissue with fulminant necrosis due to~     thermolysis in Nano-group, whereas an increase of fibrous and fibro-fatty components in~     stenting arm. We have documented 2 vs 3 cases of the definite thrombosis and 3 vs 5 cases of~     target lesion revascularization in groups respectively. The analysis of the event-free~     survival of the ongoing clinical follow-up shows the significantly lower risk of~     cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%;~     p<0.05).~      Plasmonic resonance-mediated therapy using noble-metal NP associated with significant~     regression of coronary atherosclerosis. Tested delivery approach has acceptable safety and~     efficacy for atheroregression below a 40% PB.~      The investigators hypothesize that multistep approach with the use of stent in acute care~     unit, and then subsequent transcatheter micro-injection with nanoparticles can resolve~     atherosclerosis, stop and regress atherogenesis, remodulate or even rejuvenate arteries.~     Stem cells in patch can be good carriers for nanoparticles as well as high-effective~     metabolic vectors (paracrine-like regulation of alive cells and via bioactive products of~     cell lysis after detonation of nanoparticles) for the treatment of plaque on site. Gold~     nanoparticles with silica-iron oxide shells promise high-energy plasmonic photothermic~     burning or melting effect under the near-infrared laser irradiation onto the lesion. Thus~     the investigators expect complex two-side effect on the plaque with protected lumen and~     adventitia.~      Novel discoveries in atherogenesis, and development of nanobiotechnologies with potentials~     for the management of atherosclerosis leads us to the quest of new approaches. The~     investigators still cannot really effectively treat atherosclerosis.~      The investigators management is more symptomatic, and lipid-pool or inflammation-oriented!~     The investigators cannot manage non-organic part (mineral deposits, calcified necrotic core,~     partially collagen and fibrotic tissue) and total plaque volume Surgery and invasive~     procedures is just focused on blood flow restoration (just manipulate the form of plaque) +~     concerns of clinical and technical restrictions (incl. alien body - stent) + risk of~     restenosis or subacute 'fatal' in-stent atherothrombosis + graft survival/ occlusion +~     surgery-related complications High rate of short- and long-term complications and~     readmissions. Regression of atherosclerosis in fact is still a dream. The investigators~     offer an alternative to stenting and may be cardiac artery bypass surgery (CABG). Our~     approach can really allow to rejuvenate arteries, Plasmonic photothermal therapy (PPTT) can~     burn plaque, but stem cells and bioengineered structures promise restoration of the vessel~     wall.~      Our personal previous data showed that PPTT can 1.6-fold reduce a volume of plaque with most~     optimal long-term result in subsets with the use of SPCs as a delivery approach. The most~     optimal delivery systems of NPs into the plaque are the on-artery bioengineered patch and~     ferro-magnetic approach.~   "
123733|NCT01436110|"~     A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate~     the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate~     inhalation powder in the treatment of asthma in adults and adolescents not currently treated~     with inhaled corticosteroids~   "
123734|NCT01436097|"~     Interventions to increase the consumption of fruits and vegetables to date have shown~     promise, but many have limited public health impact due to the lack of scalability of their~     designs. The investigators propose to examine the effectiveness and feasibility of an~     intervention for promoting increased consumption of fruits and vegetables by incentivizing~     their purchase. Collaborating with UpLift Solutions, the investigators will enroll shoppers~     in this Randomized Clinical Trial using the research infrastructure called the Way to Health~     platform. (called the Way to Health platform, and approved as a Prime protocol by the IRB as~     reference # 811860).~      Hypothesis: providing patients with financial incentives can promote healthier behaviors~     (e.g.: eating healthier).~   "
123735|NCT01436084|"~     The goal of this clinical research study is to learn if SB1518 can help to control~     myelodysplastic syndrome. The safety of the drug will also be studied.~      SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain~     leukemias, myelofibrosis, and lymphoma.~   "
123736|NCT01436071|"~     A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study~     to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of~     persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids~   "
123737|NCT01436058|"~     Ankle osteoarthritis is a joint condition which results from damage and loss of the~     cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at~     controlling pain and limiting motion that provokes the pain. Nonsurgical treatment~     approaches are tried first. If unsuccessful, surgical options are considered. Stem cell~     therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow~     derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.~   "
123738|NCT01436045|"~     The purpose of this study is to investigate the effect of the rapidly acting intranasal~     insulin derivative (glulisine) on memory and cognition in 12 patients suffering from~     mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose~     study. This study will further assess safety of insulin glulisine as well as the effects of~     this drug on olfaction.~   "
123739|NCT01436032|"~     The purpose of this study is to determine the analgesic efficacy and safety of N1539 in~     subjects undergoing abdominal laparoscopic surgery.~   "
123741|NCT01436006|"~     The situation in Italy regarding radiation dose to patients undergoing Multidetector row~     Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre~     check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a~     document of 1998 published by the European Commission (EUR16262/1998) based on the results~     of an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed~     Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law~     (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's~     National Radiological Protection Board, deputed to dose evaluation and protection.~      An overview of the Italian situation is relevant in order to know the actual dose levels for~     MDCT administered to patients both adults and paediatrics.~   "
123742|NCT01435993|"~     This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with~     relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital~     signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers~     of health from blood samples), tolerability (any side effects that occur, if any), and~     pharmacokinetics (how the body processes the drug and how long the drug stays in the blood,~     and in cerebro-spinal fluid). The study will also investigate if patients' own immune system~     interacts with GSK1223249.~   "
123743|NCT01435980|"~     Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type~     2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass~     and Exenatide.~   "
123744|NCT01435967|"~     The aim of this study is to monitor any impact in the change from the lyophilised~     formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for~     rotavirus gastroenteritis. This is planned to be assessed by comparing trends of~     hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years~     of age, before and after introduction of the liquid formulation of the vaccine in Belgium.~   "
123745|NCT01435954|"~     In patients with benign prostatic hyperplasia (BPH), combination therapy with an~     alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the~     progression of acute urinary retention (AUR) and the incidence of prostate surgery, and also~     provides symptom relief.~      The objective of this study is to compare the likelihood of clinical progression (defined as~     AUR and/or prostate-related surgery) and costs in BPH patients who were treated with delayed~     combination therapy to BPH patients who were treated with early combination therapy using~     data from a United States (US) healthcare claims database. The hypothesis of this study is~     that patients who are prescribed combination therapy early in their BPH treatment will~     experience better clinical outcomes and lower healthcare costs compared with patients~     treated with delayed combination therapy. The null hypothesis is that no difference will be~     observed in outcomes or direct medical costs for patients treated with early combination~     therapy and patients treated with delayed combination therapy.~      The US healthcare claims database includes data from patients with Medicare Advantage as~     well as private health plan coverage including the Impact health plan. About 14 million~     people were covered by this set of health plans in 2007 and were geographically diverse~     across the US. Data from 2000 through 2009 were utilized.~      The study is a retrospective cohort analysis.~   "
123746|NCT01435941|"~     Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary~     headache care and is associated with a number of deleterious outcomes, especially higher~     disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined~     as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that~     increase or decrease the risk of developing CM. One factor that appears especially relevant~     is symptomatic medication use. The current study builds upon and expands previous work~     considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use~     has on the likelihood of developing CM.~      This study is a retrospective observational cohort study of data collected via mail survey~     and collated in the American Migraine Prevalence and Prevention (AMPP) database.~      Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a~     longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States~     (US) households were screened and 24,000 individuals who reported severe headaches were~     identified and additional questionnaires have been administered annually. This analysis uses~     data from respondents who meet second edition of the International Headache Classification-2~     (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is~     defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.~   "
123747|NCT01435928|"~     Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This~     clinical study is designed to test the hypothesis that Lurasidone is effective in the long~     term maintenance treatment of schizophrenia.~   "
123748|NCT01435915|"~     The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR~     after single and multiple doses of the PR-formulation. It will also investigate the safety~     and tolerability of ropinirole PR after single and multiple doses of PR-formulation.~   "
123749|NCT01435902|"~     The primary objective of this study is to demonstrate that the combination of inhaled~     fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection~     throughout the day against bronchoconstriction induced by exercise compared with fluticasone~     propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with~     persistent asthma.~   "
123750|NCT01435889|"~     The purpose of this study is to assess long term (1 year) respiratory sequelae in children~     surviving an acute respiratory distress syndrome~   "
123751|NCT01435876|"~     This trial aims to determine which treatment modality is better for treatment of the~     convergence insufficiency subtype of intermittent exotropia.~   "
123752|NCT01435863|"~     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy~     in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).~   "
123753|NCT01435850|"~     Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL~     PLUS (study group).~      We compare primary and secondary stability of both hip stems for radiographic outcome using~     EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.~      Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip~     score and radiographic findings.~   "
123754|NCT01435837|"~     The purpose of the study, Effects of Interaction of Caffeine and Hydration on Voice~     Performance, is to gather information about the effects of caffeine and hydration upon voice~     performance. The research question involves whether systemic hydration may reduce~     degradation on voice performance caused by caffeine ingestion. It is hypothesized that the~     hydration conditions will result in a less degraded vocal performance as compared with the~     nonhydration condition.The investigation involves abstention from any caffeine ingestion for~     24 hours - from 8pm the day before testing to 8am the morning of testing. In addition,~     preparation for participation involves abstaining from ingesting any foods and liquids for~     12 hours - from 8pm to 8am of the following morning. Each test will take about 10 minutes.~   "
123755|NCT01435824|"~     The investigators propose to study amoxicillin absorption in a 2-stage program that will~     progressively produce, for the first time, information leading to pediatric pharmacology~     recommendations for the administration to children of amoxicillin dissolved in human milk.~     The investigators study will enroll adult volunteers as number of blood extractions, volume~     of blood required and subject availability, among other issues, generate a number of ethical~     and logistical constraints that make it almost impossible to carry such an intensive~     sampling study in infants.~   "
123756|NCT01435811|"~     The purpose of this study is to determine a suitable dose of the human norovirus GII.4~     challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible~     subjects that would be useful for evaluation of vaccines and antivirals.~   "
123757|NCT01435798|"~     This study is an NIH-funded two-part clinical trial to determine the best dose-ratio of~     individual subjects with central neuropathic pain following spinal cord injury (SCI), when~     two compounds with different target mechanisms are administered as combination therapy. The~     investigators will first determine each subjects' maximally tolerated dose (MTD) of chronic~     oral (PO) administration of dextromethorphan (Dex); the investigators will then randomize~     subjects to receive multiple dose-combinations of dextromethorphan and lidocaine (Lido). The~     investigators will be able to determine each subject's individual dose-response relationship~     for the separate compounds with adequate power, and thus also confirm the analgesic efficacy~     of high dose dextromethorphan and lidocaine, each in central neuropathic pain.~   "
123758|NCT01435785|"~     Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients,~     pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively~     assessed in this population. The aims of this study are to derive four PKPD models using~     previously published PK parameters sets, and to prospectively assess their performance in~     elderly people. With the obtained data we propose to build a specific PKPD model for this~     population.~   "
123759|NCT01435772|"~     This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion~     every 2 weeks (qow) to patients with late-onset Pompe disease.~   "
123760|NCT01435759|"~     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)~     who are taking certain types of antidepressants but continue to have residual depression~     symptoms. The purpose of this study is to help answer the following questions:~        -  How safe is SPD489 for the supplemental treatment of depression and what are the side~          effects that might be related to it?~        -  Can SPD489 help patients with depression who are also taking an antidepressant?~        -  How much SPD489 should be given to patients with depression who are also taking an~          antidepressant?~        -  How does SPD489 compare to placebo in depressed patients who are also taking an~          antidepressant?~   "
123761|NCT01435746|"~     The objective of this trial is to evaluate different transfusion strategies in patients~     after liver transplantation. Patients in the experimental arm will be given red blood cell~     (RBC) transfusion according to a liberal strategy, i. e., transfusions should be given, when~     hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be~     maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell~     (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given,~     when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be~     maintained between 8 and 10 g/dl.~   "
123762|NCT01435733|"~     The purpose of this study is to investigate whether the presence of a child with Autism~     Spectrum Disorder places parents at increased risk for divorce.~   "
123763|NCT01435720|"~     The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or~     refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by~     intravenous infusion at various doses.~   "
123764|NCT01435707|"~     There has been no reports of the effect of various kinds of steroid or various dose of~     steroid which are commonly used in the clinical setting. Previous studies have simply shown~     that the blood glucose level is elevated in diabetes patients and did not show or suggest~     the adequate strategy of epidural steroid injection in diabetes patients regarding steroid~     type, dosage or injection interval. Therefore, the investigators tried to evaluate the~     effect of different dosage of triamcinolone, which is a commonly used steroid in epidural~     steroid injection, on the blood glucose level.~   "
123777|NCT01435538|"~     Care pathways are complex interventions to support the interprofessional team in the~     redesign of their care process. This international cluster randomised trial will analyse the~     impact of the development and implementation of care pathways on the interprofessional~     teamwork.~   "
123778|NCT01435525|"~     The purpose of this study is to confirm the safety profile / factors which impact safety and~     efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium +~     amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual~     post-marketing use.~   "
123779|NCT01435512|"~     This is a research study funded by the Department of Defense to test a therapeutic~     intervention for male combat veterans who engage in intimate partner violence (IPV). The~     investigators hope to decrease the recurrence of relationship aggression and help veterans~     manage anger. The primary aim of the study is to test the intervention.~   "
123819|NCT01434992|"~     Although endoscopic findings of H. pylori have been reported in the literature, there is~     still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic~     features alone. Most studies concluded that it is not possible to diagnose H. pylori-related~     gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy~     has greatly improved in recent years and the exact examination of gastric mucosa was~     possible.~   "
123765|NCT01435694|"~     Aims of the study:~      This is a randomized-controlled trial to test the effects of robot-assisted gait training on~     locomotor function and motor unit firing rate in multiple sclerosis subjects with severe~     gait impairments. The control group will be treat with conventional physical therapy.~      Subjects and methods:~      60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.~      Informed consent will be obtained. Participants will be randomized to Robot-assisted gait~     training (experimental group) or conventional therapy (control group) through a~     randomization stratification approach, according to a block randomization of 4.~      The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2~     sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks~     (2 sessions/week), that will focus on gait training.~      Primary outcome measures will be both neurophysiological measures (motor unit firing rate~     characteristics) and clinical test for gait speed (10m walking test). Secondary outcome~     measures will include: clinical tests of walking endurance (six minute walking test),~     balance (Berg Balance Test) and mobility (Up and Go Test).~      Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue~     (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored.~     Subject acceptance and confidence in the treatments will be track with a Visual Analog~     Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after~     6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to~     evaluate treatments retention, by a clinician blinded to the treatment.~   "
123766|NCT01435681|"~     This is a research study using transcranial magnetic stimulation (TMS) to investigate~     interactions between the sensory system and the motor cortex in primary generalized dystonia~     (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.~      The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor~     cortex is the part of your brain where nerve impulses control voluntary muscle activity.~   "
123767|NCT01435668|"~     The purpose of this study is to evaluate the effectiveness of a Brief Motivational~     Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful~     drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested~     positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.~      Patients receive either an information leaflet or an information leaflet plus a referral to~     a psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face~     interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are~     also invited to attend the BMI session. If necessary, patients can be referred to relevant~     care and treatment services for alcohol misuse.~      In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are~     allocated to the treatment group and 140 to the control group. Randomisation is stratified~     according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used~     for randomisation.~      Alcohol consumption is measured by self-report at 3 months. The principal criteria used to~     assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks~     in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking~     and driving, sexual intercourse without protection will also be assessed. It is the first~     clinical trial in France comparing these two interventions among young patients in ED with~     this design.~   "
123768|NCT01435655|"~     Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.~   "
123769|NCT01435642|"~     This study is conducted in Africa. The aim of this non-interventional study is to evaluate~     the current status of diabetes management, complications and psychosocial aspects for~     children with type 1 diabetes in Algeria.~   "
123770|NCT01435629|"~     This study is conducted in Japan. The aim of the study is to evaluate the efficacy of~     somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia /~     hypochondroplasia enrolled in the GH-1941 study (NCT01516229).~   "
123771|NCT01435616|"~     The purpose of this study is:~        -  To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of~          treatment.~        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin~          glargine during 52 weeks of treatment.~        -  To compare the number of patients on LY2605541 reaching blood sugar targets without low~          blood sugar episodes at night to those taking insulin glargine after 52 weeks of~          treatment.~        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin~          glargine after 52 weeks of treatment~   "
123772|NCT01435603|"~     The purpose of this study is to compare ways of giving advice and providing support to~     improve diet and physical activity in adult primary care patients with elevated body mass~     index and dysglycemia.~   "
123773|NCT01435590|"~     OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to~     diagnostic and patient discomfort.~      METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be~     randomized to endocervical sampling with either a metal curette (endocervical curettage~     -ECC) or and endocervical brush. All samples will be submitted for histological study.~   "
123774|NCT01435577|"~     The purpose of this trial is to established the safety and efficacy of multiple dose~     treatment with tapentadol IV in an adult population with moderate to severe pain following~     bunionectomy.~   "
123775|NCT01435564|"~     The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical~     activity intervention in sedentary men and women.~   "
123776|NCT01435551|"~     From the past research that has been done the investigators have learned that brain cells~     die & leave a deposit in the brain known as beta-amyloid. Since alzheimer's is a slow acting~     disease the natural immune system does not respond to this illness so this builds up in the~     brain. As it builds up it gets into the neurotransmitters in the brain causing more brain~     cells to die. As these buildups occur dementia sets in due to more of the brain dying &~     effects normal activity.~      STUDY WAS CANCELLED~      Hypnotherapy will be used to do the following things:~        -  Increase the immune system~        -  The immune system will begin to clean up the beta-amyloid buildup~        -  That removes damage cells of the brain~        -  Increase more blood flow to the brain~        -  Allows the active brain cells to be trained to carry out daily activities~      STUDY WAS CANCELLED~   "
123791|NCT01435356|"~     The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic~     product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the~     bladder. A course of 13 injections will be administered over 27 months.~   "
123780|NCT01435499|"~     The primary objective of this study is to evaluate the safety and feasibility of~     administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine~     (melanoma GVAX), alone or in combination with low dose cyclophosphamide (CPM), for the~     adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily,~     the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma~     GVAX, including serological and cellular immune responses in patients treated with either~     the vaccine alone or the vaccine given with low dose CPM.~   "
123781|NCT01435486|"~     Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea~     is a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a~     trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central~     nervous system stimulant. In apnea of prematurity, caffeine is believed to work by~     increasing central respiratory drive.~      Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September~     2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.~      A randomized, double-blind, controlled trial with a sample size of 45 patients per group~      Data Collection methods, instruments used measurements:~      Randomization:~      In the emergency department, the patients will be assigned to either one of the two~     treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will~     prepare sequential sealed vials containing the experimental drugs. Randomization code will~     be revealed only after all patients completed the study. The medical team in addition to the~     patients will be blinded to the medication delivered. There will be no detectable difference~     in the color, smell of the two study treatments.~      Guardians or parents of eligible infants will be approached regarding the study, explaining~     the purpose and the treatment modalities. Patients will be included after obtaining a verbal~     and written consent.~      Study Intervention:~      Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine~     citrate (25mg caffeine citrate equal to 12.5mg caffeine base).~      Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study~     medications will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous~     over 30 minutes using syringe infusion pump.~      After random assignment, eligible infants will receive one of the study treatments.~     Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and~     antipyretics may be used as per the discretion of the treating physician.~      After stabilization of patients as usually done in Pediatric Emergency Center , patients~     will be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring~     when indicated.~   "
123782|NCT01435473|"~     Thromboembolic complications (TCs) are important causes of morbidity and mortality after~     pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and~     late post-surgical complications, early reoperation, neurologic and organ damage, and~     potentially death. The true incidence of blood clots in pediatric surgical patients is~     unknown.~      The overarching objective of this study is to further our understanding of TCs, including~     quantification, characterization and risk stratification. This study will ultimately allow~     the development of effective tools for prevention and early identification of TCs, rather~     than focusing on treatment alone.~   "
123783|NCT01435460|"~     This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%)~     versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief~     of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).~   "
123784|NCT01435447|"~     Allogeneic stem cell transplantation is potential curative therapy for adult acute~     lymphocytic leukemia (ALL). Based on our previous study, the condition with iv-busulfan~     (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation~     mortality and long-term survival is comparable to most data reported with slightly higher~     relapse rate particularly for patients in CR2. In this study, the investigators aim to~     further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell~     transfusion as consolidation for ALL and graft-versus-host disease (GVHD) prophylaxis.~   "
123785|NCT01435434|"~     The study is a prospective, trial to test the safety and feasibility of injecting~     autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high~     risk non union/delayed fractures. Another objective is to turn this procedure to a standard~     care protocol in our department .~   "
123786|NCT01435421|"~     Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic~     function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies~     include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide,~     infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA,~     ALF is most frequently caused by paracetamol intoxication.~      The MBT can produce immediate results to aid in decision making in patients with acute liver~     disease. Such a test may affect decision-making regarding transplantation in this setting,~     facilitate appropriate discharge from critical care to other hospital units and to home,~     provide point of care assessment of therapeutic interventions.~      The BreathID can potentially help in determining:~        -  Parameter to include patients in transplant list (the UNOS 1A group)~        -  Identification that patient deteriorates and needs extended hospitalization/referral to~          ICU/change in management~        -  An addition to the MELD and or other scores to estimate risk in other acute patients~        -  Additional information to that of other commonly utilized prognostic scoring systems~      The primary end-point of the study is to develop a model to predict deterioration of the~     liver disease, which incorporates measurements from the MBT along with other potential~     variables. The data collected will be used to develop a prediction model using data-mining~     methodology (linear and non-linear regression models, binary trees, neural networks, etc…).~     The predictive models may include measurements from the MBT, blood test results, as single~     measurements or as trend over time. The model that will be developed, will attempt to~     predict the disease deterioration vs. recovery accurately, at an earlier time point than the~     standard procedure. A threshold will then be determinate based on adequate sensitivity and~     specificity levels.~   "
123787|NCT01435408|"~     This study focuses on Cardioprotective strategies.~   "
123788|NCT01435395|"~     This is a single-center (Emory University), open-label, single arm, phase I study to assess~     safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of~     temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring~     anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are~     accepted.~   "
123789|NCT01435382|"~     This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615~     in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.~   "
123790|NCT01435369|"~     The purpose of this research study is to see if the study drug, CT-011, is safe to give and~     if it helps people with melanoma that has spread to other areas of their body. CT-011 is a~     monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by~     infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab~     instead of by the immune system which then recruit the immune system to help fight cancer~     cells.~      All final eligible subjects will receive an intravenous infusion of CT-011. This study will~     test two dose levels of the study drug:~      Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).~      Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).~      Each group will be given the study drug through an IV (a needle put into a vein in the arm)~     on day 1. After day 1, the study drug will be given every other week. Patients may be given~     a total of up to 27 study drug infusions for about 12 months while they are in the study.~     Approximately 100 patients will participate in this study.~   "
123794|NCT01435317|"~     Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of~     chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient~     setting.~        -  Identification of early indicators for therapy success~        -  Comparison of different patient groups regarding: tinnitus severity, tinnitus duration,~          level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex~          forms~        -  Representative set of safety data in a broad patient spectrum~        -  Measurement of tinnitus burden (TBF-12 Questionnaire)~        -  Generation of longterm compliance data~   "
123795|NCT01435304|"~     This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte~     solution) and loss of plasma proteins responsible for normal blood clotting as well as~     platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device~     qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as~     Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for~     Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery~     (cardiac surgery performed without the use of blood or blood products). The system is~     designed to filter excessive water from blood left in the heart lung machine~     (cardiopulmonary bypass) after it is separated from the patient during the performance of~     cardiac surgery. Consequently the likelihood of excessive post-operative bleeding and~     transfusion with allogeneic blood (blood bank blood from donors) is decreased.~   "
123796|NCT01435291|"~     A pharmacokinetics and pharmacogenetics study to complement the current knowledge of~     tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at~     steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on~     tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after~     renal transplantation.~      Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus~     immediate release (Prograf®)~   "
123797|NCT01435278|"~     To date, there is no clinical evidence on the efficacy and safety of Glucosanol in~     maintaining weight loss beyond the study duration of 12 weeks. The rationale for this~     open-label study is to assess the efficacy in preventing regain of loss body weight and~     safety of Glucosanol in subjects who are overweight or obese over a longer period after the~     initial weight loss.~   "
123798|NCT01435265|"~     This is a phase IV randomized, prospective open label study to asses the efficacy of an~     extended nurse eduction program in improving adherence to the prescribed treatment regimen~     in the treatment of moderate to severe psoriasis vulgaris.~   "
123799|NCT01435252|"~     Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled~     in this study. Patients are treated with standard chemoradiation in combination with~     concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation~     therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study~     is to investigate if cetuximab consolidation therapy improves the 2-year locoregional~     control rate.~        -  Trial with medicinal product~        -  Trial with radiotherapy~   "
123800|NCT01435239|"~     Partial cuff inflation before insertion is generally used for laryngeal mask airway~     insertion in children. However, it is not proven how much the cuff should be inflated. The~     aim of this study is to compare efficacy between the method using the resting volume and the~     method using half the maximum volume for partial cuff inflation.~   "
123801|NCT01435226|"~     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,~     Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in~     Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV)~     Infection.~   "
123802|NCT01435213|"~     The purpose of this study is to validate [11C]ORM-13070 as an alpha2C-adrenoceptor imaging~     agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor~     occupancy.~   "
123803|NCT01435200|"~     Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients~     receiving platinum based chemotherapy than oral iron?~   "
123804|NCT01435187|"~     In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic,~     physiologic and clinical data obtained during the initial hospitalization will predict~     respiratory morbidity as defined by respiratory health care utilization and respiratory~     symptoms, between discharge and 1 year corrected age.~      This protocol describes a collaboratively developed multicenter study of very preterm~     infants from birth through the time of discharge from the Neonatal Intensive Care Unit~     (NICU) and up to 1 year of age, corrected for the degree of prematurity.~   "
123805|NCT01435174|"~     End-stage renal disease (ESRD) patients often develop cardiovascular complications, and~     cardiovascular disease is the leading cause of death in this population. Ranolazine's~     ability to treat angina without reducing heart rate or blood pressure makes it an important~     option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose~     pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD~     patients on and off hemodialysis. Results of the proposed study will provide initial dosing~     estimates for a follow-up, multiple-dose pharmacokinetic study in this population.~   "
123806|NCT01435161|"~     Different lowing blood pressure strategies have a different clinical efficacies. Blocking~     the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial~     fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months~     than 30% compared to Nifedipine( Adalat GITS ).~      A total of 160 subjects will be included in two study groups. The Group 1 will receive~     80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS).~     Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and~     24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial~     fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg.~     Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood~     pressure during the study.~   "
123820|NCT01434979|"~     The investigators goal is to monitor and quantify the differential physiologic and biomarker~     responses of controls to standardized exercise under thermoneutral and thermally challenged~     conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged~     environment to develop unique bio-signature panels to predict those at risk for exertional~     heat illness (EHI) and guide return to duty following an episode of EHS.~   "
123807|NCT01435148|"~     Recurrent major depressive disorder affects about 3−5% of the population. It is anticipated~     that by 2020, depression will be the most common cause of disability worldwide in the 18−55~     age group. About two−thirds of these patients respond to first−line treatment~     (antidepressants). In addition, prolonged administration of antidepressants in patients who~     respond results in remission in 80% of patients per year. However, a significant proportion~     of patients either fail to respond in spite of determined pharmacological treatments,~     electroconvulsive therapy and other treatments or do not achieve sustained remission. The~     personal, psychiatric, medical, social and economic consequences are devastating for these,~     treatment resistant, patients. This investigation aims to evaluate the feasibility of deep~     brain stimulation in patients with treatment resistant depression as a viable alternative to~     ablative neurosurgery.The hypothesis is that some patients will respond to stimulation in~     one site rather than the other and that some patients will respond to double rather than~     single site stimulation.~   "
123808|NCT01435135|"~     The purpose of this study is to assess safety and tolerability of late boost regimens of~     AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected~     participants from RV 144.~   "
123809|NCT01435122|"~     The main purpose of this study is to see whether Axitinib will help prolong the time that~     the patient's carcinoid tumors remain stable, and to examine their treatment response~     through testing. Researchers also want to find out if Axitinib is safe and tolerable.~   "
123810|NCT01435109|"~     Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain~     and disability among adults. Many adults with OA have significant pain and functional~     limitations, even though they receive some medical care for their OA. Efforts are needed to~     help adults improve OA-related outcomes. This study will examine three different approaches~     for helping adults manage their OA-related symptoms. The study will compare a patient-based~     intervention (involving exercise, weight management, and cognitive behavioral pain~     management), a provider-based intervention (involving provision of patient-specific~     recommendations for care, based on evidence-based guidelines), and a combination of the two~     interventions, relative to usual care among patients with hip and/or knee osteoarthritis.~     The interventions are relatively low cost and easy to disseminate, with the patient~     component being telephone based. This study will provide novel, valuable information of the~     effectiveness (and cost-effectiveness) of these three interventions in the context of~     real-world clinical settings.~   "
123811|NCT01435096|"~     The purpose of this study was to determine the maximum tolerated dose and the recommended~     dose of BN80927 in patients with advanced malignant solid tumors.~   "
123812|NCT01435083|"~     The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD)~     characteristics of desmopressin melt are in nocturia patients (compared to healthy~     volunteers and children). The main questions the investigators want to answer are:~        -  Are differences related to the pathophysiological factors involved in nocturia?~        -  Are there age/gender/size differences?~        -  Can the investigators identify patients who are likely to develop hyponatraemia?~        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?~      Day 1:~        -  Patient is being hospitalized in the morning~        -  General anamnesis and clinical examination~        -  Uroflow and residue measurements (3x)~        -  Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and~          creatinin~      Day 1-2:~      - In the evening at 20h:~        -  start (with empty bladder!) 24h miction-incontinence-residue registration: urine~          collections every 3 hours (every portion of urine within a period of 3 hours must be~          collected in the same collection device), with: registration of volumes and measurement~          urinary concentrations of Na+, Cl-, osmolality and creatinin~        -  Measurement of blood pressure during 24h~      Day 2-3:~        -  In the evening at 19h (day 2): drink 15mL/kg water~        -  At 20h: take desmopressin melt 120µg + start:~             -  24h miction-incontinence-residue registration: registration of volumes and~               measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)~             -  Measurement of blood pressure during 24h~             -  Collection of urine:U1 at 19h, U2 at 20h, together with intake of first~               desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2~               after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6~               at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after~               desmopressin melt intake~             -  Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin~               melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+,~               Cl-, osmolality and creatinin (safety profile)~             -  At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour~               during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and~               creatinin: U8 at 9h, U9 at 10h, U10 at 11h~        -  Patient can go home on day 3, unless he is at high risk for side effects, high-risk~          patients are hospitalized for 7 days~   "
123813|NCT01435070|"~     Patients attending the University Hospital Coventry UK with a broken wrist requiring an~     operation, will be invited to enter the study. At the first visit, they will have an xray of~     the wrist and will be asked to complete a number of questionnaires. The questions are to~     determine if they normally have pain in the wrist and how well they can perform their daily~     activities. The patient will then have an operation, and the fracture in the wrist will be~     held in the correct position with either a metal plate and screws or wires.~      At 6 weeks following the operation the patient will be reassessed and an xray will be taken.~     At 3 months, 6 months and 12 months after the operation patients will perform tests to~     assess the strength of their grip, pinch and movement of their wrist. In addition they will~     complete the the same questionnaires from their first visit. At the 12 month visit patients~     will have another xray.~   "
123814|NCT01435057|"~     In this project, the investigators will test the hypothesis that predominant (two to three~     times a week 60 min) strength training is more effective in reducing visceral fat mass than~     endurance training in obese patients.~   "
123815|NCT01435044|"~     This study was designed to assess the safety and efficacy of multiple interferon-free~     treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938)~     alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated~     over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit~     (sustained virologic response [SVR]) versus risk (safety and resistance).~   "
123816|NCT01435031|"~     A prospective, multi-center, single-arm study to establish the safety and effectiveness of~     the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary~     Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary~     Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective~     percutaneous revascularization of native chronic total coronary occlusions~   "
123817|NCT01435018|"~     This study is being done to compare the safety and efficacy of three combination treatments~     for Kaposi's Sarcoma and AIDS.~   "
123818|NCT01435005|"~     The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at~     understanding what dose (or volume) of exercise will best reduce the risk for breast cancer,~     particularly among women who are between the ages of 50-74. The primary aim is to compare~     the effects of a high versus moderate volume exercise intervention on specific biological~     intermediate endpoints for breast cancer in a group of previously inactive postmenopausal~     women~   "
123821|NCT01434966|"~     The purpose of this study is to determine if interventions applied at a distant site,~     lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied~     locally at the knee (TENS) on quadriceps force output and activation as well as reports of~     pain during common exercises in individuals with PFPS.~   "
123822|NCT01434953|"~     The purpose of this study is to find out whether labeling adults with prehypertension has~     negative effects on clinic blood pressure and quality of life 3 months after diagnosis.~   "
123823|NCT01434940|"~     The global aim of our study is to validate eye movement recording as an early differential~     diagnostic tool, in order to discriminate as early as possible between neurodegenerative~     dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to~     put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD~     respectively. Eye movements are sensitive markers of neurological diseases and can be used~     in a variety of clinical neurological syndromes.~      This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy~     persons. The patients AD will be recruited in the Memory Centre of Resources and Research of~     Besançon and patients DPD will be selected in the psychiatric department of the University~     Hospital of Besançon. The control participants will be recruited from the entourage of~     researchers and patients. The selection of participants in the 3 different groups is based~     on clinical examinations in psychiatry and neurology and neuropsychological assessments.~     After giving informed consent, patients will be evaluated by a psychiatrist and a~     neuropsychologist. The complete assessment takes 150 minutes.~      After having set up patients, eye movements will be recorded using video-oculography~     techniques. The following tasks are performed: the basic dynamic eye movements (latency,~     hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter)~     will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The~     emotional connotation tasks will be assessed by scan of images pair with emotional~     connotation and portrait analysis. The assessment takes 30 minutes.~      This study will include 3 groups:~        -  an Alzheimer group;~        -  a depressed group;~        -  a control group with healthy persons. The population of this study will be comprised of~          patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and~          not neuropsychological sequelae that could disrupt the functioning oculomotor.~      These people will be recruited on a voluntary basis, after notification and consent in the~     research center, the Psychiatry Clinical Department of the University Hospital of Besançon.~     This study was conducted over a period of 36 months.~   "
123824|NCT01434927|"~     The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy,~     in a setting where routine sedation for colonoscopy is standard practice and to characterize~     the subset of patients willing to try and potentially completing an unsedated procedure.~   "
123825|NCT01434914|"~     This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in~     patients with chronic leg ulcers. The study will be conducted at a single center with a~     total of 70 patients. Patients will be randomized to either the octenisept® group or to the~     placebo group.~   "
123826|NCT01434901|"~     Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the~     intestine that are released into the blood immediately after ingestion of a meal. Together,~     these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by~     increasing acetylcholine release in pancreatic islets. This study will determine if a~     Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and~     reduces blood glucose levels after ingestion of a mixed meal.~   "
123827|NCT01434888|"~     The objective of this study is to investigate the pharmacokinetics, safety and tolerability~     of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC)~     to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy~     volunteers.~   "
123828|NCT01434862|"~     This is a scientific research study that will look at how a closed-loop system and the~     drug Pramlintide may work together to improve blood sugar control in people with type 1~     diabetes mellitus. Pramlintide is approved by the Food and Drug Administration (FDA) and is~     given as an injection (subcutaneous) that works with insulin to lower blood sugar.~   "
123829|NCT01434849|"~     The purpose of this trial is to see if a topical beta blocker is effective in preventing the~     proliferation of infantile hemangioma.~   "
123830|NCT01434836|"~     The goal of this project is to train currently major depressed patients on fundamental~     aspects of working memory while the investigators administer transcranial Direct Current~     Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these~     training sessions. This working memory training would be performed using adaptive Paced~     Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory~     training combined with tDCS or sham placebo (10 sessions) will be measured on different~     variables, each measured at the start and at the end of the two weeks of training. The~     investigators expect the greatest anti depressant results and cognitive enhancements in the~     group of depressed patients that received tDCS combined with working memory training.~   "
123831|NCT01434823|"~     The Hospital of the University of Pennsylvania's Medical ICU (MICU) is implementing a model~     of 24-hour intensivist staffing in September 2011. Funds and resources are not available to~     cover the entire year, only certain weeks will be covered. The investigators propose a~     randomized clinical trial to study the comparative effectiveness of nocturnal intensivist~     staffing in the HUP MICU on patient outcomes. The investigators will be collecting and~     analyzing patient data of all patients admitted to the MICU from September 12, 2011, to~     September 11, 2012.~   "
123832|NCT01434810|"~     The primary objective of this study is to determine the safety and efficacy of filtered~     sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The~     subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The~     rationale for conducting the study is that in Nigeria, and other countries that may not have~     effective commercial light devices or have reliable access to electric power to operate~     them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal~     jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight~     phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical~     trial comparing the efficacy of filtered sunlight phototherapy with conventional~     phototherapy.~   "
123833|NCT01434797|"~     The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic~     value in the detection of permanent central venous catheters (PCVC) infection when~     conventional means of PCVC infection detection are non-conclusive.~   "
123900|NCT01433926|"~     Main objective: To analyze the clinical and biological characteristics of patients with~     disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete~     remission, partial or stable disease for a period exceeding 3 years.~      In addition, there will be a sub-genetic analysis of patients in whom there is availability~     a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with~     routine clinical practice, as the tumor samples based on which will be held on genetic~     profile, have been preserved in paraffin was extracted from the primary tumor to the~     patient.~   "
123834|NCT01434784|"~     The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire~     Lung Cancer 13 (EORTC QLQ-LC13) is considered as a standard instrument to assess the quality~     of life (QL) of lung cancer patients. Since its publication in 1994, major clinical advances~     have been made. The research objective is to develop a revised lung cancer module that (a)~     covers all QL aspects relevant in the context of newly available diagnostic and therapeutic~     options, (b) is applicable in both non-metastatic and metastatic cancers, (c) and covers QL~     aspects that are generally relevant for patients with lung cancer but are missing in the~     original module. This project will comprise the first three project phases according to the~     Module Development Manual (www.eortc.be/qol).~   "
123835|NCT01434771|"~     The purpose of this study will be to compare standard of care invasive methods to an FDA~     approved non-invasive device and a novel wireless non-invasive device, both manufactured by~     Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by~     the novel device to the measurements taken by the standard of care invasive monitors.~   "
123836|NCT01434758|"~     Detection of M. tuberculosis in clinical specimens of children has a low sensitivity because~     specimens are either difficult to collect or contain low levels of M. tuberculosis.~     Diagnostic criteria are non-specific and culture confirmation is challenging, as sputum~     samples are not often obtainable from small children and specimens typically have low yield.~     Although children are typically thought to have paucibacillary disease, they are at greater~     risk for dissemination of TB. This may allow for detection of Mycobacterium tuberculosis~     from other bodily fluids than sputum or gastric aspirate, including blood and urine.~     Unfortunately, little is known about the overall yield from these various specimens. From~     pilot data collected among adults and children in Tugela Ferry, we know that it is feasible~     to collect and test various bodily fluid specimens for TB culture. This study aim to test~     the hypothesis that blood and urine cultures will detect Mycobacterium tuberculosis from~     children suspected of disseminated TB, and that a proportion of these non-sputum bodily~     fluids will detect both drug-susceptible and drug-resistant tuberculosis when sputum or~     gastric culture does not.~   "
123837|NCT01434745|"~     The purpose of this study is to determine if simvastatin improves development and behavior~     in patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol~     supplementation.~   "
123838|NCT01434732|"~     Premature babies are at risk for bleeding in their brains, which can result in developmental~     delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical~     cord immediately after birth is standard, but delaying this procedure allows more of the~     baby's blood to move from the placenta into the baby and prevents head bleeds. However, a~     delay in clamping the umbilical cord is not usually done in very premature babies, because~     it would delay their treatment and they could get cold. Milking the umbilical cord is~     another way to give premature babies more of their own blood while avoiding a delay in~     treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the~     need for blood transfusions, and increase the amount of urine made in the first few days of~     life.~   "
123839|NCT01434719|"~     This study aim to test the hypothesis that human S.suis infections are associated in time~     and space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or~     other diseases in pigs.~   "
123840|NCT01434706|"~     The investigators propose to study the impact of nucleic acid amplification testing (NAT)~     screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and~     Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity~     Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction~     with routine rapid HIV testing at HIV counseling and testing sites and venues in the San~     Diego county. The overarching goal of this study is to develop and implement a system to~     identify, notify and engage into care those individuals with recent HIV infection in order~     to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and~     to evaluate and characterize HIV transmission dynamics within the San Diego population.~   "
123841|NCT01434693|"~     This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and~     7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo),~     double-blind, placebo-controlled study to evaluate the safety of a single dose of oral~     CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's~     Disease.~   "
123842|NCT01434680|"~     The study was to evaluate the safety and and immune response of each of three lots of~     Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy~     Toddlers.~   "
123843|NCT01434667|"~     This study is intended to examine the impact of receiving a genetic risk assessment for~     Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).~   "
123844|NCT01434654|"~     Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related~     complications despite the use of highly active antiretroviral therapy (HAART). Such~     complications are termed HIV neurocognitive disorders (HAND) and comprise a spectrum from~     asymptomatic neurocognitive impairment (ANI), through mild cognitive impairment (MCI) to~     severe HIV dementia (HAD).~      Prior to HAART approximately 30% of patients with advanced HIV disease had cognitive~     impairment; with HAART the incidence of HAND has decreased but its prevalence increased. The~     reasons for the ongoing development of cognitive impairment in HAART treated patients are~     not clear. They might relate to virus induced brain injury prior to starting HAART, the~     onset of a separate neurological process, toxicity related to HAART, or ongoing viral~     infection in the brain.~      It is clear that the ability of different antiretroviral drugs to penetrate the brain varies~     but what is not established is whether these differences between drugs lead to different~     neurological outcomes. The investigators propose to study HIV infected patients stable on~     HAART for 12 months; subdividing the groups according to the brain penetrance of their drug~     combination. Patients would undergo neuropsychological assessment and MRI brain scan at the~     start of the study and after 12 months.~      Differences in neuropsychological tests and MRI would be sought between treatment groups to~     establish whether HAART with better CNS penetration is associated with better outcome and~     fewer MRI changes.~   "
123901|NCT01433913|"~     This randomized phase II trial studies how well metformin hydrochloride works compared to~     placebo in treating patients with prostate cancer undergoing surgery. Metformin~     hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for~     cell growth and stop the growth of tumor cells.~   "
123845|NCT01434641|"~     This protocol details a novel myocardial perfusion Single Photon Emission Computed~     Tomography (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi~     during exercise or regadenoson pharmacologic stress and undergo a full-time SPECT~     acquisition processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients~     receive a high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest~     scan, also processed with WBR. All enrolled research subjects will undergo both the initial~     stress and subsequent rest scan.~      The radiation exposure associated with this new stress/rest protocol is equivalent to that~     of the conventional rest/stress protocol presently in routine clinical uses at SLRHC.~      Eventually, when and if this novel stress/rest protocol is adopted in routine clinical~     practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi~     (331 mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear~     Medicine Laboratory.~      All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or~     suspected coronary artery disease will be candidates for enrollment. Fifty patients~     undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic~     stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.~   "
123846|NCT01434628|"~     A range of observational and epidemiological studies have shown that the lifetime risk of~     HIV infection can be reduced by 70% through male circumcision.~      Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million~     adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this~     goal, the government launched a national study, based on the WHO Framework for Evaluation of~     Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when~     compared to surgical circumcision.~      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male~     circumcision in resource limited settings.~      Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study~     (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was~     bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was~     managed with minimal intervention.~      Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates~     Foundation, and WHO audited the study site. The Safety and Efficacy study results were~     published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and~     presented in CROI 2011 and AUA 2011.~      To achieve its national catch up campaign with minimal burden to the overly strained~     health system, which lacks physicians and surgical infrastructure, Rwanda needs to task~     shift the procedure to nurses. This study is meant to test the Safety and Efficacy in the~     hands of non-surgically trained nurses from the A1 and A2 cadres.~   "
123847|NCT01434615|"~     The purpose of this study is to (a) characterize the current management of patients with~     systolic heart failure (HF) in South Asia following an educational intervention of current~     guidelines and delivery of disease management tools and (b) to characterize the effect of~     current therapy on clinical outcomes in patients managed by tertiary care centers across~     South Asia. Current therapy includes characterization of the post market performance of any~     market released Medtronic cardiac resynchronization therapy (CRT) or cardiac~     resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac~     resynchronization therapy (CRT).~   "
123848|NCT01434602|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose~     and best schedule of the combination of everolimus and sorafenib that can be given to~     patients with malignant glioma.~      The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib~     can help to control malignant glioma. The safety of this combination will also be studied in~     both phases.~   "
123849|NCT01434589|"~     The purpose of this study is to 1) determine the efficacy of manualized Short-term Treatment~     of Internet and Computer game Addiction (STICA), assess 2) the durability of treatment~     response in these patients and 3) the impact on associated psychiatric symptoms, e.g. social~     anxiety and depression.~   "
123850|NCT01434576|"~     The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics~     of HGS1025 in patients with moderate to severe ulcerative colitis.~   "
123851|NCT01434563|"~     To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population~     of HIV positive patients within a primary care setting compared with the HIV negative~     population. The investigators aim is to assess the use of optimal screening methods to~     assess HAND. For this the investigators will be comparing the performance of a group of~     persons who are HIV positive and a group of persons who are HIV negative to test their~     memory and concentration abilities over-time.~   "
123852|NCT01434550|"~     The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer~     and to find out what effects, good and/or bad, this treatment will have on participants and~     their cancer.~   "
123853|NCT01434537|"~     Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric~     operation room setting for a 4 weeks period. Assessment of usability, anonymous clinical~     register of every venepuncture(age, gender, size, weight, punction site, number of attempts,~     time until successful cannulation, local anaesthesia, general anaesthesia, pain scales:~     faces pain scale und BPS/BPOS).~   "
123854|NCT01434524|"~     The long-term outcomes of branched-chain amino acid (BCAA) administration in patients~     undergoing hepatic resection remain unclear. The aim of this study is to assess the impact~     of oral supplementation with BCAA on the prevention for the development of liver~     tumorigenesis in patients undergoing liver resection.~   "
123855|NCT01434511|"~     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment~     of serious bleeding episodes in people with congenital hemophilia A.~   "
123856|NCT01434498|"~     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,~     Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in~     Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.~   "
123857|NCT01434485|"~     The purpose of this study is to confirm the safety profile / factors which impact safety and~     efficacy of Nexium capsules in daily clinical usage for the patients who have been~     prescribed Nexium for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux~     oesophagitis, non-erosive reflux disease, or Zollinger-Ellison syndrome~   "
123858|NCT01434472|"~     This phase II trial studies the side effects and how well high-dose yttrium-90~     (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation [CD]20) followed by fludarabine~     phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell~     transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has~     returned after a period of improvement (relapsed) or has not responded to previous treatment~     (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can~     find cancer cells and carry cancer-killing substances to them with less effect on normal~     cells. Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT~     helps stop the growth of cancer cells. It may also stop the patient's immune system from~     rejecting the donor's stem cells. However, high-dose radiolabeled antibodies also destroy~     healthy blood cells in the patient's body. When healthy stem cells from a donor are infused~     into the patient (stem cell transplant), they may help the patient's body replace these~     blood cells. Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate,~     TBI, and donor PBSCT may be an effective treatment for patients with B-cell lymphoma.~   "
123859|NCT01434459|"~     Therasphere is a form of treatment that has been designed to selectively deliver radiation~     to the cancer within the patient's liver. This form of treatment has been used in a number~     of clinical trials and has been approved for use in the treatment of liver cancer.~      The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with~     TheraSphere (radioactive beads that are injected directly into the blood vessel supplying~     the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic~     cancer or cholangiocarcinoma (bile duct tumors) involving the liver.~   "
123860|NCT01434446|"~     In the late 1990s, researchers discovered that acoustic stimuli slow progressive~     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can~     delay the loss of auditory function. In addition, prolonged exposure to an augmented~     acoustic environment could improve age-related auditory changes. These ameliorative effects~     were shown in several types of mouse strains, as long as the acoustic environment was~     provided prior to the occurrence of severe hearing loss.~      In addition to delaying progressive hearing loss, acoustic stimuli could also protect~     hearing ability against damage by traumatic noise. In particular, a method called forward~     sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to~     reduce noise-induced hearing impairment in a number of mammalian species, including humans.~      Interestingly, recent report has suggested that low-level sound conditioning also reduces~     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and~     reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically,~     increased cochlear sensitivity was observed when distortion product otoacoustic emissions~     (DPOAEs) and compound action potentials (CAPs) were measured.~      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of~     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing~     ability against acoustic trauma and to prevent the cortical map reorganization induced by~     traumatic noise.~      In this study, the investigators examine the effect of sound stimulation on hearing ability~     in human subjects.~   "
123861|NCT01434433|"~     This study will evaluate method correlation and mean bias between six B-type natriuretic~     peptide (BNP) platforms.~   "
123862|NCT01434420|"~     Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high~     histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse~     prognosis than the other forms of breast cancer. It is however a heterogenous group for~     histological and molecular level, but also for evolution. Most of the TN is part of the~     basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.~      Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are~     mostly of basal type and their prognostic seems better that what could be expected from high~     grade tumours and without hormonal receptors. They would be much more frequent in the TN~     group. However, at this day, no prospective study was led to estimate this incidence, or to~     study the intervention of other genes of predisposition, as well to analyse the links~     between this phenotype and their consequences at the germinal or somatic level, in terms of~     associated molecular changes and prognosis.~      The purpose of this study is, on a prospective study, to lead a joined analysis at the~     germinal level, in search of mutations of the main genes of breast cancer predisposition~     (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and~     transcriptome), by correlating these results to the main clinical parameters.~      The 5 years relapse-free survival will also be estimated.~   "
123863|NCT01434407|"~     The purpose of the meal study is to investigate acute effects on satiety and inflammation of~     advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the~     meal is affected by food preparation methods: frying/grilling versus boiling/steaming.~   "
123864|NCT01434394|"~     EGFR is a potential target for new anticancer therapy in head and neck squamous cell~     carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the~     stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced~     apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is~     that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for~     locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The~     endpoints of this study are the pathological complete response after neo-adjuvant~     Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the~     safety.~   "
123886|NCT01434108|"~     The main objective is to evaluate the effectiveness of the experimental drug to reduce~     plasma ammonia concentration at a dose that is safe and well tolerated. Ammonia usually~     rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis~     of the liver. This increase in the concentration of ammonia facilitates the development of~     hepatic encephalopathy.~      The study will be divided in two parts:~      Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to~     confirm the tolerance and safety of the dose of OP that is being proposed for the study~     according to the results of phase I and phase II studies in healthy subjects and stable~     outpatients with cirrhosis.~      Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group~     trial. Assignment of treatment will be done according to a list (one at each study site) of~     random numbers in blocks that will be concealed until the end of the study. The control~     group will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.~   "
123865|NCT01434381|"~     Background:~      - The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing~     in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent~     parasites from developing in the mosquito. As a result, the mosquito will not spread malaria~     to the next person it bites. However, the vaccine will not directly prevent people from~     getting sick with malaria. Researchers want to test the safety of and response to this~     vaccine.~      Objectives:~      - To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~        -  They will be assigned to a study group to have either two or three doses of the~          vaccine. Participants will have checkups after each dose of vaccine,~        -  The additional doses will be given 2 months or 2 and 4 months after the first vaccine.~        -  Participants will have regular blood tests to check the level of the response to the~          vaccine.~        -  They will be followed for up to 1 year after the last vaccine to have any additional~          tests as needed.~   "
123866|NCT01434368|"~     Despite the clear importance of adolescence in the emergence of a number of disease states~     and processes, there is surprisingly little known about how the endocrine and metabolic~     events accompanying puberty in humans impact normal developmental neurobiology.~     Epidemiologic studies have identified sexual dimorphisms in the prevalence of several~     neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many~     of these sex differences emerge during or shortly after puberty and are maintained until the~     5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in~     women compared with men does not appear until adolescence, and prior to puberty girls are~     not at increased risk relative to boys. Puberty is a structured, transitional process that~     can be influenced by both nutritional factors and environmental stressors; nonetheless, the~     variability in the timing and duration of puberty is largely determined by oligogenic~     inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying~     puberty impact on many of the physiologic systems involved in the regulation of brain~     function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal~     remodeling, and the pruning of cortical connectivity). Additionally, not only does stress~     during puberty increase the risk of disturbances in affective adaptation during adulthood,~     but the events accompanying puberty modify stress responsivity (e.g., alterations in the~     duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to~     stressors). Moreover, animal work has demonstrated that neural connectivity differs in a~     brain regional specific manner according to the stage of puberty (i.e., early versus late).~     In humans, puberty also occurs in stages, and although the endocrinology of puberty,~     surprisingly, has not been fully characterized with longitudinal data, studies have~     documented that the physical changes measured by Tanner stages I to V are accompanied by~     progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless,~     there remains considerable variability in the timing and duration of this otherwise highly~     structured reproductive transition.~      We propose to perform a longitudinal, naturalistic study examining changes in brain~     structure and function, behavior, and stress responsivity in boys and girls across the~     pubertal transition. Because the pubertal transition is defined by a complex series of~     physiologic events that emerge sequentially over several years and involve changes in~     multiple endocrine and growth systems, and because there is also considerable variability in~     the timing of these events reflecting the influence of both genetic and environmental~     factors, puberty cannot by delineated by age of the participants as has been done in most~     imaging and other neurobiological studies of adolescence. The present study will formally~     bridge this gap by defining pubertal events per se in participants.~      Participants will include healthy boys and girls whose pubertal status will be assessed, and~     in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten~     month intervals from age eight years (pre-puberty) until age 17 years (post-puberty).~     Reproductive endocrine, metabolic, and physical measures will be employed to characterize~     the stage and duration of pubertal development. Outcome measures will be derived via~     multimodal neuroimaging techniques, cognitive/behavioral assessments, metabolic~     measurements, and evaluations of HPA axis function. Additionally, the impact of genetic~     variation on the developmental trajectory of these parameters (both reproductive and CNS)~     will be determined.~      This cross-institute proposal will employ a multidisciplinary approach to evaluating the~     effects on CNS function of the process of puberty in both boys and girls. This work will not~     only serve to inform research on the mechanisms by which sexual dimorphisms in~     neuropsychiatric disorders develop, it will also have important implications for the~     prevention and treatment of these disorders.~   "
123867|NCT01434355|"~     This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with~     germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva~     from patients with cancer in the laboratory may help doctors learn more about changes that~     occur in DNA and identify biomarkers related to cancer.~   "
123868|NCT01434342|"~     RATIONALE: Continued smoking after a cancer diagnosis has important health consequences~     beyond the risks associated with smoking in the general population. Smoking reduces the~     efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the~     negative consequences, it is estimated that between 15-75% of patients with cancer continue~     to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head &~     neck, and cervical cancer patients were chosen because there is evidence of potential~     clinical benefit associated with quitting smoking in all of these populations and they~     represent a mix of both smoking and non-smoking related cancers.~   "
123869|NCT01434329|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients respond to~     treatment.~      PURPOSE: This research trial studies DNA in samples from patients with acute myeloid~     leukemia.~   "
123870|NCT01434316|"~     This phase I trial studies the side effects and the best dose of veliparib and dinaciclib in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment. Veliparib and dinaciclib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
123871|NCT01434303|"~     This phase I trial studies the side effects and best dose of entinostat when given together~     with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has~     spread from the original (primary) tumor to distant organs or distant lymph nodes or has~     recurred (come back) at or near the same place as the original (primary) tumor, usually~     after a period of time during which the cancer could not be detected. Entinostat and~     lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the~     ability of tumor cells to grow and spread. Giving entinostat together with lapatinib~     ditosylate and trastuzumab may kill more tumor cells.~   "
123872|NCT01434290|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Given radiation therapy in different~     ways may kill more tumor cells.~      PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works~     in treating patients with prostate cancer.~   "
123873|NCT01434277|"~     This study is to evaluate the safety of a new preservative in a lubricant eye drop used four~     times a day in healthy adults and subjects diagnosed with dry eye.~   "
123874|NCT01434264|"~     Energy healing is among the most commonly used forms of complementary and alternative~     medicine among cancer patients. There are, however, few studies on the effects of energy~     healing for cancer and cancer associated symptoms and none of them are of a volume or~     quality that allows reliable conclusions to be drawn. Qualitative studies on energy healing~     in Denmark have demonstrated that the interventions are individualized and the expected~     outcomes personalized. This research points to the need for a research design that can~     evaluate personalized outcomes of individualized treatments and at the same time adhere to~     general demands of external and internal validity.~      The objective of this study is to test the effectiveness of energy healing as an~     individualized rehabilitative intervention to improve outcomes of personal choice among~     persons who have completed a conventional intended curative treatment for colorectal, breast~     and prostate cancer. The study is designed as a pragmatic clinical trial with personalized~     outcomes.~      The study attempts to maximize external validity by using a design that incorporates~     important features of energy healing administered in real-life settings: 1a) allowing~     participants self-selection to healing and non-healing control, 1b) assessing individual~     participant-selected treatment goals, 1c) allowing the treatment to be performed in the~     private clinics of the healers. To maximize internal validity similar to that obtained in a~     randomized, clinical trial design, the study will 2a) randomize participants to~     self-selection and randomized groups of intervention and control; and 2b) supplement the~     assessment of personalized treatment goals with assessment of outcomes with standardized~     measures.~      The study will account for a number of possible moderators of the effects, including 3a)~     socio-demographics and 3b) previous experience with complementary and alternative treatment.~     Outcome measures will be assessed by questionnaires, physical measurements, data from~     administrative registries as well as semi-structured interviews and participant observation.~     Possible patterns in the various forms of data will be examined for concordances and~     discrepancies.~      Finally, the methods will be discussed in terms of their generalizability as a model for~     evaluating personal outcomes of individualized treatments with high levels of external and~     internal validity.~   "
123887|NCT01434095|"~     A half-dose photodynamic therapy, a relative new treatment, has been widely performed to~     treat central serous chorioretinopathy.~      The researchers aimed to investigate whether the therapy improved the patient's visual~     acuity as well as the retinal sensitivity. The researchers also investigate which clinical~     factors, if any, were associated with the results; visual acuity or retinal sensitivity~     after the treatment.~   "
123902|NCT01433900|"~     A 1-year prospective, randomized, investigator-masked trial comparing the confocal and~     clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved~     prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.~   "
123903|NCT01433887|"~     The Chinese patients with chronic hepatitis C have a different genetic background, which had~     been demonstrated to significantly influence their responses to pegylated interferon and~     ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6~     infection were treated with pegylated interferon and ribavirin. Their response was compared~     amongst different genotypes.~   "
123875|NCT01434251|"~     Hypotension in the very preterm infant (gestational age [GA] <32 wks) is a frequently~     occurring clinical problem. Although no real consensus has been reached on the definition of~     hypotension in these infants, in clinical practice a mean blood pressure (mean BP) in mmHg~     lower than the GA age in weeks is considered to be the starting point for anti-hypotensive~     therapy. However, although an association between neonatal hypotension and mortality/~     morbidity exists, there is no evidence of causality between hypotension (meanBP <GA in~     completed weeks) and neonatal mortality/morbidity. In addition, using mean BP alone as the~     indication of treatment of neonatal cardiovascular compromise without taking into~     consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to~     vasoactive medication. This medication can be potentially harmful to these extremely~     vulnerable patients.~      The aim of this study is to compare neonatal mortality and short-term neurodevelopmental~     outcome (cerebral ultrasound during the first 7 days of life, advanced MRI indices of~     structural brain injury at term GA) and long-term neurodevelopmental outcomes (Bayley scales~     of infant development III [BSID-III] at 24 months) between two groups of very preterm~     infants presenting with hypotension without clinical and laboratory evidence of compromised~     tissue perfusion during the first 3 days of life. Hypotension will be defined as the mean BP~     (in mm Hg) lower than the infant's GA (in weeks). Patients randomized to Group A will be~     treated according to the treatment protocol operative in the Neonatal Intensive Care Unit~     (NICU) of the University Medical Centre Utrecht (UMCU) while Group B will receive no~     cardiovascular support for hypotension unless they have evidence of compromised tissue~     perfusion and end-organ function ((i.e. near infrared-monitored regional cerebral oxygen~     saturation (ScO2) <50% despite optimized ventilatory support and FiO2 administration, plasma~     lactate >6 mmol/L; and/or urine output <0.6 mL/kg/hour) or mean BP >5mmHg lower than the~     current guideline.~      The investigators hypothesize that there will be no differences between the two groups~     concerning short and long-term neurodevelopmental outcomes.~   "
123876|NCT01434238|"~     The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant~     feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12~     months of age.~   "
123877|NCT01434225|"~     NEMO is a multicentre pan European clinical trial with the aim to develop new treatment~     strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There~     is evidence that bumetanide improves GABAergic function of the current standard drug,~     phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around~     thirty years. This trial should confirm that Bumetanide in addition to standard treatment~     will result in better seizures control.~   "
123878|NCT01434212|"~     The purpose of this study is to determine whether the outcome of interferon therapy on HCV~     infected patients can be early precisely predicted with a novel mathematic method with~     Chinese population.~   "
123879|NCT01434199|"~     As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more~     and more screening colonoscopies are now being performed for prevention or early detection~     of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential~     to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate~     is highly variable and dependent on individual experience. Colonic looping is the commonest~     cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological~     imaging technique to provide real time, three-dimensional image and position of the~     colonoscope during the procedure. It may facilitate straightening of colonic loops and hence~     cecal intubation.~      The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across~     endoscopists of all levels of experience by making use of the newly developed Endoscopy~     Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.~      The investigators propose to conduct a prospective randomized controlled trial to compare~     the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance.~     Colonoscopies performed by endoscopists with different level of experience will be~     randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient~     controlled sedation (PCS) containing propofol and alfentanil will be given to all patients.~     The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal~     intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower~     sedative medication requirement. A high caecal intubation rate facilitates a reliable~     colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce~     patient discomfort during the procedure. It may also facilitate learning and acquiring the~     skill of colonoscopy in trainees.~   "
123880|NCT01434186|"~     To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination~     with Metformin in pediatric patients with type 2 diabetes~   "
123881|NCT01434173|"~     Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired~     respiratory tract infections, complicated intra-abdominal infections, and pelvic~     inflammatory disease. In the clinical development program, moxifloxacin was associated with~     some hepatic adverse drug reactions. To evaluate further the hepatic safety profile of~     moxifloxacin, a retrospective cohort study with nested case-control analysis will be~     conducted to assess the rate of noninfectious acute liver injury among new users of~     moxifloxacin and of other antimicrobials prescribed for similar indications, including~     amoxicillin, amoxicillin plus clavulanic acid, cefuroxime, clarithromycin, doxycycline,~     levofloxacin, and telithromycin.~      The study will be implemented in the population included in the HealthCore Integrated~     Research Database (HIRD). Eligible patients are adults aged 18 years and older with~     continuous enrollment in the HIRD for at least 6 months before their first claim for a~     prescription for a study antimicrobial. Follow-up will start at the date of the first~     prescription until the date of the earliest of the following events: noninfectious acute~     liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from~     database, or death. Patients with chronic alcoholism or cirrhosis, infectious hepatitis,~     HIV/AIDS, or pregnant women will not be included.~   "
123882|NCT01434160|"~     The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped~     intrauterine contraceptive system in female adolescents under 18 years of age. Approximately~     300 generally healthy, post-menarcheal female adolescents with regular menses at the~     beginning of the study requiring contraception will be enrolled into the study.~      Duration of study treatment is approximately 12 months with an option to continue the use of~     the contraceptive system up to three years if the woman is willing to continue the use after~     the first 12 months.~      The incidence of adverse events over 12 month treatment period will be the main outcome of~     this study. Also the efficacy (number of pregnancies), discontinuation rate and~     pharmacokinetics will be evaluated.~   "
123883|NCT01434147|"~     Phase II pilot study of a preoperative induction chemotherapy in combination with~     Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal~     carcinoma~   "
123884|NCT01434134|"~     Women treated for breast cancer are at increased risk for cardiovascular disease, including~     heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators~     want to assess if heart failure medications such as beta blockers and angiotensin receptor~     blockers can prevent cardiac dysfunction during early breast cancer therapy.~   "
123885|NCT01434121|"~     The major goal of this project is to determine whether intravenously infused ascorbic acid~     is safe for use as a viable therapeutic strategy in adult humans with sepsis.~   "
123950|NCT01433250|"~     The study will assess the long-term safety and tolerability of AIN457 in patients with~     relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of~     maintenance of efficacy and health related quality of life will be explored.~   "
123888|NCT01434082|"~     The investigators are doing this study to look at sleep problems, daytime sleepiness, and~     thinking and behavior patterns in children with arthritis and in children without arthritis.~     Arthritis is a problem with joints. Some children have arthritis and some children do not~     have arthritis.~      Sleep disordered breathing is a sleeping problem in which some children snore and have~     pauses in their breathing during sleep. It is associated with not enough or fragmented~     sleep, poor school performance, problems paying attention, and behavior problems.~      The investigators do not know how many children with arthritis have sleep problems, and how~     it is linked to daytime sleepiness and children's learning, and behavior patterns compared~     to children without arthritis. The investigators need to study both children with arthritis~     and children without arthritis to learn more about these connections and to understand if~     they are the same or different in children with arthritis and in children without arthritis.~   "
123889|NCT01434069|"~     This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and~     FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated~     dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.~   "
123890|NCT01434056|"~     The purpose of this study is to determine whether hepatic encephalopathy, measured through~     magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds~     prognostic information to patients who are waiting for liver transplantation. If this model~     improves mortality prediction this might be used in the future for organ allocation.~   "
123891|NCT01434043|"~     This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity,~     specificity, positive and negative predictive value, and receiver operator curve area under~     the curve) of cardiac computed tomography (CT) perfusion as compared to the best~     non-invasive test of blood flow -- cardiac positron emission transmission (PET) perfusion~     imaging.~      The primary outcome of the study is to determine the CT perfusion technique with the highest~     overall diagnostic accuracy measured by the highest area under the receiver operator curve.~      The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual~     inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C)~     Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a~     distributed 2-region analysis~      A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic~     accuracy. Using the CT perfusion data, the investigators will model the minimal number of~     cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full~     data set.~      A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT~     perfusion to identify regions of low blood flow as compared to PET perfusion alone.~   "
123892|NCT01434030|"~     Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an~     artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well~     as translational modeling and engineering development. In order to be successful,~     closed-loop control in Type 1 Diabetes Mellitus (T1DM) must adapt to individual physiologic~     characteristics and to the behavioral profile of each person. An essential part of this~     adaptation is biosystem (patient) observation. The investigators propose to lay the~     foundation for a closed-loop control system which will include algorithmic observers of~     patients' behavior and metabolic state.~   "
123893|NCT01434017|"~     Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with~     or without adenoidectomy may be as high as 75%.~      Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and~     serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic~     antiemetic treatments:~        -  dexamethasone alone (250 mcg/kg)~        -  dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)~        -  dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).~   "
123894|NCT01434004|"~     The purpose of this study is to determine whether a vegetable-based diet, physical activity~     program, and stress reduction training will reduce or maintain PSA levels, an indicator of~     prostate cancer progression, in men who have had their prostate gland removed following a~     prostate cancer diagnosis.~   "
123895|NCT01433991|"~     This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a~     Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which~     will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum~     tolerated dose (MTD) of E7050 and E7080 (lenvatinib) in combination in subjects with~     unresectable advanced or metastatic solid tumors. In the subsequent Phase 1b expansion~     cohort and Phase 2 cohorts, additional subjects with recurrent glioblastoma or unresectable~     Stage III or Stage IV melanoma and disease progression after prior systemic treatment will~     be enrolled to confirm the MTD (expansion cohort) and to further explore the clinical~     activity of E7050 and lenvatinib.~   "
123896|NCT01433978|"~     Core study:~      To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in~     addition to standard of care) for the treatment of adult participants with chronic immune~     thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet~     response.~      Open-label Extension Phase:~      To evaluate the safety and tolerability of long-term therapy with avatrombopag in~     participants with chronic ITP (cITP).~   "
123897|NCT01433965|"~     The purpose of this study is to determine whether lenalidomide can stop the growth of~     leukemia stem cells and can be used to prevent the return of leukemia cells after a~     transplant.~   "
123898|NCT01433952|"~     Elevated levels of thiamine may increase cellular energy metabolism by increasing the~     activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial~     affect in patients with several diseases including sepsis, heart failure, and diabetes.~     There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.~      The aims of this study are to:~        -  Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral~          thiamine in healthy volunteers;~        -  Compare the different thiamine doses on the pharmacokinetic variables using repeated~          measures ANOVA.~   "
123899|NCT01433939|"~     The investigators wish to study the effects of position changes during colonoscope insertion~     on patient comfort. The investigators hypothesize that early position changes would reduce~     colonoscope loop formation and patient discomfort.~   "
124350|NCT01428011|"~     The purpose of this study is to understand how communication between African American and~     white patients with high blood pressure and his/her primary care provider effects whether a~     patient decides to take their high blood pressure medications.~   "
123904|NCT01433874|"~     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter~     hospitalizations, and less post-operative pain as compared with traditional laparotomies.~     However, there is marked interindividual variability of post-operative shoulder-tip pain~     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and~     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours~     after surgery.~      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic~     nerve irritation causes referred pain to C4. Therefore, the investigators should try to do~     is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.~      This clinical controlled trial is tried to find out the practical and clinical maneuver to~     reduce post-operative should-tip pain following laparoscopic surgery.~   "
123905|NCT01433861|"~     The choice of surgical strategy for patients with proximal gastric cancer is controversial~     mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and~     anastomotic stricture. but there are no prospective randomized trials until now.~      The primary end point of this study is whether the rate of reflux esophagitis is different~     or not between LAPG and LATG. Through this study, we~   "
123906|NCT01433848|"~     The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in~     studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac~     changes were caused not only by the myotoxic effects of alcohol, but also are present in~     many patients regardless of etiology of cirrhosis.~      These changes are characterized by abnormalities of systolic contraction in patients~     undergoing physical or pharmacological stress, changes in diastolic function and~     electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy.~     Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.~      To date no studies have evaluated the clinical relevance of changes in the heart of~     cirrhotic patients, or their relationship with the prognosis of affected patients. Til now,~     researches are based on strict echocardiographic parameters, not including several modern~     methods of assessment of cardiac systole and diastole. New techniques, such as~     two-dimensional strain, can bring new diagnostic and prognostic information, and it is not~     reported in the literature. Therefore, the aim of this study is to determine the~     morphological and functional cardiac changes in patients with cirrhosis and their prognostic~     role by evaluating new echocardiographic parameters of systolic and diastolic readings.~   "
123907|NCT01433835|"~     The purpose of this study is to determine the safety and pharmacokinetics following a single~     oral dose of MBX-400.~   "
123908|NCT01433809|"~     This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies~     (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their~     utility in pre-operative diagnosis, in particular to distinguish benign from malignant~     throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for~     somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to~     obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.~   "
123909|NCT01433796|"~     Background: Increased access to antiretroviral therapy (ART) in Africa will require~     decentralization to primary health care. For this purpose, adapted methods for management of~     patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in~     patients starting ART, and assessment of co-administration of ART and TB treatment are~     priorities in this field.~      Aims: To identify clinical predictors of TB in patients starting ART, and to construct~     screening algorithms for TB in this population; to assess ART outcomes in patients receiving~     TB treatment at health centre level.~      Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of~     HIV positive patients initiating ART is prospectively followed. Baseline characteristics are~     registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as~     well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV~     RNA levels are followed. Patients with TB are compared to those without TB with regard to~     ART outcome. Baseline factors associated with TB will be used to construct TB screening~     algorithms.~      Recruitment of the cohort was completed in March 2013; follow-up for determination of long~     term outcome of ART will be continued until 2016.~      Significance: These studies give insight into TB-HIV co-infection at primary health care~     level in a Sub-Saharan region, and may impact future guidelines for management of such~     patients.~   "
123910|NCT01433770|"~     Alefacept, also known as Amevive®, is a medication approved by the Food and Drug~     Administration (FDA) in the United States and other countries for the treatment of~     psoriasis, which is a chronic inflammatory immunological skin condition that can result in~     chronic dry, red patches that are covered in scales. Alefacept is approved by the FDA for~     the treatment of psoriasis but not as an anti-rejection medication in transplant patients.~     It is now being tested in new kidney transplant patients as a supplement to other approved~     anti-rejection drugs. Alefacept will be used as an investigational drug in this study.~      The reason for this study is to test whether using Alefacept will inhibit T cells, known as~     memory cells, using a test named ELISPOT-IFN. In patients with psoriasis, Alefacept inhibits~     these memory cells. If memory cells specific to your donor can be inhibited by this drug, it~     might prevent rejection and promote acceptance of the transplanted kidney in a unique~     manner.~   "
123911|NCT01433757|"~     The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated~     in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to~     patients treated with a placebo. A placebo is a pill that looks and tastes the same as the~     real drug, but without the active ingredient. The second objective of this study is to~     determine if dystonia symptoms improve while on the study drug.~   "
123912|NCT01433744|"~     The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in~     patients with chronic periodontitis in comparison with those without periodontal disease and~     that the non-surgical periodontal treatment would decrease levels of CRP in patients with~     chronic periodontitis.~   "
123913|NCT01433731|"~     The purpose of this study is to investigate the safety and tolerability of topical SHP141~     applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell~     Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients~     with Stage IA, IB, or IIA CTCL.~   "
123914|NCT01433718|"~     Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant~     burden on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism,~     with more than 70% of them occurring while landing from a jump. Female athletes are at~     higher risk of sustaining a noncontact ACL injury due to the higher number of risk factors~     that they possess compared to their male counterparts. Due to this statistic, ACL prevention~     programs have been developed over the past 15 years in attempt to reduce this risk among the~     female athletic population. These programs have been shown to reduce the rate of noncontact~     ACL injuries in females by correcting the risk factors associated with them. However, it~     remains unclear as to whether these positive results are solely due to the program or a~     higher exercise workload in its participants. The purpose of this study is to evaluate the~     effectiveness that an ACL prevention program has on modifying at-risk landing mechanics~     (associated with noncontact ACL injury) compared to a resistance training program of equal~     workload.~   "
123915|NCT01433705|"~     Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactively~     labelled tracers) in the heart using PET imaging for subsequent use in the evaluation of~     clinical patient studies using these procedures.~      Normal healthy volunteers will be extensively screened for this study. Subjects will be~     given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects~     not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will~     undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the~     hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin~     according to standard procedures in our laboratory. These same individuals will also undergo~     an inflammation F-18 FDG protocol after following a high fat, protein permitted, no~     carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG~     radiotracer will be administered IV per protocol.~   "
123916|NCT01433692|"~     Background: Cannabis is the most prevalent illegal drug used in France, and consequences~     arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are~     now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular~     diseases and psychiatric and social problems. The general practitioner (GP) is the health~     professional most viewed by adolescents. Brief interventions (BI) for adult alcohol use have~     been shown to be efﬁcient. Some BI have been designed to inspect adolescents and consumption~     of cannabis have been piloted, showing their feasibility, but no test has validated them.~      Aim : Does a BI conducted by general practitioners reduce consumption of canabis in 15 to 19~     years old ?~      Method:~      Two preliminary qualitative studies (with adolescents and GP), were used to analyze the~     difficulties of communication around cannabis use. The Scientific Committee has analyzed the~     results and developed a workshop around BI, adapted to adolescents cannabis users.~      CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized~     controlled trial, clustered study, comparing an intervention group (IG) and a control group~     (CG). The intervention is the achievement of the IB during a specific consultation. The~     outcome is the consumption of cannabic (Number of joints / month).~      The study will be carried out in 3 french regions : Auvergne, Rhône-Alpes and~     Languedoc-Roussillon. 150 GPs wil be recruited and randomized in intervention group or~     control group (ratio 1 :1).~      Each GP will inlcude 5 adolescents (i.e. a total of 750 adolescents) - . The number of~     adolescents needed has been calculate with hypothesis of a significant difference of 30% in~     consumption of cannabis between adolescents who beneficied of BI (IG) and those who do not~     experienced BI ( CG) A pilot study has been conducted. Cannabis use by adolescents has~     decreased. Their perception of cannabis has changed: they are aware of the harmful effects~     of their consumption. This pilot study has improve many points of the protocol.~      Results:~      A decrease of 30% of consumption is expected (joints per month). Perception of cannabis by~     adolescents will be reviewed.~      Conclusions:~      To validate an IB adaptated to consultation with adolscents cannabis consumer in order to~     provide a tool for GP in their daily practice.~   "
123917|NCT01433679|"~     The primary purpose of this study is to test whether rewarding physical activity with a~     motivational website will increase physical activity levels in middle school-aged children~     over six months. As a secondary outcome, the study also tests the intervention's impact on~     biological measures of inflammation and metabolic function in a sub-set of study~     participants who agree to provide blood samples.~   "
123918|NCT01433666|"~     The aim of the current project is to validate PDE4 inhibitors as a target for cognition~     enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will~     demonstrate whether memory, but also attention, information processing or executive function~     improves with the PDE4 inhibitor roflumilast in healthy humans.~   "
123919|NCT01433653|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for~     complicated grief is superior to wait list condition in patients with comorbid complicated~     grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be~     compared to changes in the wait list group.~   "
123920|NCT01433640|"~     This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D~     (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than~     95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study~     will then be used to design additional studies.~   "
123921|NCT01433627|"~     This protocol describes a study to compare intended trans-radial versus trans-femoral~     intervention and bivalirudin monotherapy versus current European standard of care consisting~     of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via~     the use of one of the three available agents on the market (e.g. abciximab, tirofiban or~     eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management~     strategy. This study will be conducted in compliance with Good Clinical Practices (GCP)~     including the Declaration of Helsinki and all applicable regulatory requirements.~   "
123922|NCT01433614|"~     Anthracycline-taxane regimens are effective means of postponing progression in metastatic~     breast cancer. It is yet unclear whether addition of capecitabine to this combination~     improves the treatment outcome.~      Patients with advanced breast cancer are randomized to first-line chemotherapy with a~     combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in~     combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2~     plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and~     capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side~     effects.~      Primary endpoint is progression-free survival (PFS); secondary endpoints are overall~     survival (OS), time to treatment failure (TTF), objective response (OR), safety and quality~     of life (QoL).~   "
123951|NCT01433237|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from patients with~     rhabdomyosarcoma.~   "
124271|NCT01429051|"~     The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of~     intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long~     term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.~   "
123923|NCT01433601|"~     This project aims to assess different antiretroviral treatment strategies, optimally~     controlled and conventional, in relation to drug resistance and virological treatment~     failure. A Randomised Controlled trial (RCT) where Vietnamese HIV+ patients with CD4+~     T-cells <200/ul are randomized into either enhanced treatment support (ETS) through peer~     supporters or The National AIDS Control Program recommended self supervised treatment (SST).~     The treatment strategies will be assessed and compared in relation to treatment adherence~     and drug resistance development with virological treatment failure as primary endpoint. The~     results from this project will lead to an increased knowledge in relation the impact of~     treatment support on adherence, virological suppression and resistance development and have~     an impact on HIV treatment policies in low income settings globally.~   "
123924|NCT01433588|"~     The purpose of this study is to see if the Calmer is more effective at managing acute pain~     in preterm infants in the neonatal intensive care than the current standard of care in the~     unit.~      Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain~     scores and lower heart rates, and more stable autonomic regulation as measured by heart rate~     variability indices, than infants given a soother plus facilitated tucking (standard of~     care) during routine blood collection.~   "
123925|NCT01433575|"~     This single-center, open-label, single dose, randomized, two-way cross-over study will~     evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese~     volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20~     mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be~     re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.~   "
123926|NCT01433562|"~     This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the~     efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a~     neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast~     cancer.~      The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The~     neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each~     cycle will be 21-28 days.~   "
123927|NCT01433549|"~     The purpose of this study was to assess the impact of lens-free (recovery) intervals of~     varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.~   "
123928|NCT01433536|"~     Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster~     than in other patients. However, such patients are also occasionally prone to bone formation~     in soft tissues such as muscle. This process is called heterotopic ossification and tends to~     occur around joints. Patients with heterotopic ossification often suffer from complications~     such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of~     movement can also interfere with function and the quality of life of patients already~     experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene~     become difficult and even impossible, which worsens the loss of autonomy.~      Previous research has suggested that an osteoinductive factor (which has the capacity to~     induce the formation of bone) may be released into the bloodstream following a head or~     spinal cord injury. The investigators laboratory has shown that a growth factor called~     BMP-9, when injected into a damaged mouse muscle, has the ability to cause strong~     ossification in damaged muscle. The investigators would like to find out whether the levels~     of BMP-9 and/or its receptor (which is called ALK1) increase after traumatic brain and~     spinal cord injuries that occur at the same time as serious orthopaedic traumas.~      The main goal of the investigators study is thus to determine whether BMP-9 levels increase~     in the serum of trauma patients.~   "
123929|NCT01433523|"~     The purpose of this trial is to investigate if treatment with house dust mite allergen~     immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust~     mite induced asthma.~   "
123930|NCT01433510|"~     The purpose of this study is to assess the safety profile of specific immunotherapy with~     Grazax for three consecutive grass pollen seasons.~   "
123931|NCT01433497|"~     The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day~     versus placebo in the treatment of patients with primary progressive multiple sclerosis or~     relapse-free secondary progressive multiple sclerosis.~   "
123932|NCT01433484|"~     This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by~     improving lifestyle factors which underlie the development of CVD. The first steps will~     involve conducting a comprehensive formative evaluation to assess individual, interpersonal,~     organizational, community, and policy factors relevant to CVD risk and risk reduction in~     Lenoir County. This will be followed by a community-based lifestyle intervention program~     designed to improve eating patterns, promote physical activity, and for those who are~     interested, support weight loss. A randomized trial comparing the effectiveness of two~     community based weight maintenance interventions will also be conducted. Community-wide~     policy and environmental change interventions will also be implemented to support the~     individual-level interventions, including partnerships with businesses to promote a healthy~     environment through innovative economic opportunities. In addition, this project will~     explore genetic factors associated with cardiovascular disease risk and treatment success.~   "
123933|NCT01433471|"~     The purpose of this study is to understand the immune response activated in the human~     gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.~   "
123934|NCT01433458|"~     This study will assess the pharmacokinetics of RLX030 during and after administration in~     subjects with mild to severe hepatic impairment and matched healthy control subjects.~      20 to 24 patients and 20 to 24 healthy subjects will be enrolled.~   "
123935|NCT01433445|"~     This study will assess safety as well as establish a Recommended Phase II dose of the~     combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F~     mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential~     Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).~   "
123952|NCT01433224|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies samples from younger patients with malignant germ cell~     tumor progression.~   "
123953|NCT01433211|"~     The purpose of this study is to investigate the association between nutrition and frailty in~     older community-living persons.~   "
123936|NCT01433432|"~     The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the~     clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in~     subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD)~     therapy is aimed at reducing inflammation via induction of remission after a flare-up and~     maintenance of the remission for as long as possible. The questions being asked in this~     extension study are:~        1. For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and~          safety status achieved following 12 weeks of treatment be maintained or improved~          following an additional 12 weeks of DR-6MP treatment?~        2. For subjects who received oral Purinethol (1-1.5 mg/kg daily) for 12 weeks: Can the~          clinical efficacy and safety at 12 weeks be maintained or improved following the~          introduction of 12 weeks of 80 mg DR-6MP treatment?~   "
123937|NCT01433419|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875~     in diabetic patients.~   "
123938|NCT01433406|"~     The purpose of this study is to evaluate the safety and efficacy of long-term treatment with~     TAK-875 in diabetic patients.~   "
123939|NCT01433393|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875~     in diabetic patients.~   "
123940|NCT01433380|"~     The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses~     of PF-05175157 in healthy volunteers~   "
123941|NCT01433367|"~     This study will be a non-randomized trial consisting of patients with single level (C3 to~     C7) symptomatic cervical disc disease who have not previously received fusion surgery at the~     same level, and have failed to improve with conservative treatment for at least 6 weeks~     prior to enrollment, or who present with progressive neurological symptoms or signs in the~     face of conservative treatment.~   "
123942|NCT01433354|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data~     for AFQ056 in eligible adolescent patients with FXS who have participated in the~     CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS~     patients below 18 years of age provided the patient is at least 12 years of age at the time~     of entry into the current study.~   "
123943|NCT01433341|"~     Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of~     electronic signals emitted by four footplates, one for each heel and toe, respectively.~     These are sensitive to vertical pressure produced by a subject standing straight but in~     various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields~     additional parameters not obtained by the traditional monoplate stabilometers, namely,~     weight-distribution patterns and correlation among six combinations of paired outputs from~     the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric~     synchronizations).~      Most athletic injuries occur at the end of an activity, when the participant is fatigue. It~     is likely that significant portion of the injuries result from instability of the lower~     extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue~     increase postural sway, impaired muscle control, and increase the onset delay of movement.~     Comparing pre-exercise with post-exercise results for each athlete, should detect~     significant and clinically meaningful differences with the Tetra-ataxiametric measures of~     stability, interaction between Fourier Spectral Power Ranges of body sway, weight~     distributions, and synchronizations of toe parts. The method is suitable for young subjects,~     and the equipment is portable and tests can be conveniently carried out in a child's~     familiar training setting and right before/after exercise.~      The goal of the present study is to measure the balance of the athletes after different~     types of exercises, to measure the ability of the athletes to recover different types of~     exercises, and to measure the influence of increasing physical fitness on balance ability.~     Fifty basketball and football players between the ages of 12 and 18 years old will be~     examined following informed consent from the children and their legal guardian. Each~     participant would be measured three times during the year (pre-season, middle-season, and~     post-season), three times each (before-training, after aerobic warming-up, and~     after-training) on the Tetrax. Additionally, physical parameters (as height, and weight),~     anatomical parameters (as leg length), and joint range of movement, would be record.~   "
123944|NCT01433328|"~     Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating~     pulmonary arterial hypertension but infusion site pain may be very severe in some patients.~     The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion~     of lidocaine (a local anesthestic) to treat the pain.~   "
123945|NCT01433315|"~     Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The~     investigators wish to determine whether 9 nights of modest sleep restriction results in~     activation of cardiovascular disease mechanisms, thus potentially increasing the risk of~     cardiovascular disease. The investigators hypothesize that sleep restriction will result in~     elevated blood pressure, inflammation, and neurocognitive deficits.~   "
123946|NCT01433302|"~     The goal of this clinical research study is to measure the amount of inflammatory proteins~     inside the body before and after lymphatico-venular bypass surgery. This will help doctors~     learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can~     improve how well the surgery works.~   "
123947|NCT01433289|"~     The purpose of this study is to determine the safety, toxicity, dosing, and antiviral~     effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered~     orally twice daily at three different doses in HIV-1-infected clinically stable,~     treatment-naïve and treatment-experienced adults not on concomitant antiretroviral (ARV)~     therapy.~   "
123948|NCT01433276|"~     Indication: Resuscitation in pts with hemorrhagic shock due to multiple injuries~      Prospective, open label RCT in pts. with traumatic hemorrhagic shock in RS Hasan Sadikin~     Hospital, Indonesia.~      PI: Dr. Kiki Lukman, PsBD(K), Surgery, RSHS. Co-PI: (late)Prof. Xavier Leverve MD, PhD,~     Directeur, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier,~     France~      Hemorrhagic shock is a cause of death in trauma.Fluid resuscitation to ensure stable~     hemodynamics and microcirculation by rapidly restoring circulating plasma volume could be a~     cornerstone of managing trauma patients. Excessive fluid accumulation particularly in the~     interstitial tissue should be avoided. Hypertonic solution shows promise in restoring~     intravascular volume expansion and microcirculation with less fluid infusion in hypovolemic~     patients. This study investigated efficacy and safety of hyperosmolar Na lactate(Totilac®)~     for resuscitating traumatic hemorrhagic shock patients.~      Patients with multiple injuries with grade III hemorrhagic shock and RTS ≥4 received std~     initial fluid resuscitation of upto 2 liters of isotonic crystalloid. They also got similar~     dose of either hyperosmolar Na lactate or ringer's lactate. Hemodynamic status, fluid~     balance and and safety was recorded during the study.~   "
123949|NCT01433263|"~     A safety & efficacy clinical study of the investigational medicinal product BYM338 for the~     treatment of unintentional weight loss in patients with cancer of the lung or the pancreas~   "
123954|NCT01433198|"~     Aim:~      - to investigate the effects of an aquatic exercise program in patients with severe scars~      Patient population:~        -  10 patients of at least 18 years old~        -  patients with scars after burns or other severe skin injuries~        -  stratification into two groups: an intervention group and a control group~      Method:~        -  8 patients will participate in the aquatic exercise group and 2 patients in the control~          group~        -  assessment of physical fitness parameters, scar tissue and psychosocial impact~      Hypothesis:~      - patients of the aquatic exercise group will recover sooner and better (physically and~     psychologically) than patients of the control group~   "
123955|NCT01433185|"~     Early accurate diagnosis is one of the first crucial steps in care for infants born to~     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early~     diagnosis and results in significant reductions in infant morbidity and mortality. There is~     little information on evidence-based interventions that specifically target improved~     attendance of postpartum clinic visits and subsequent infant HIV testing in the context of~     prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators~     propose a randomized controlled trial to examine the effect of text messages sent to women~     enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early~     infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the~     hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their~     attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text~     messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV~     testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy~     to improve adherence to postnatal clinic visits and increase the uptake of infant HIV~     testing. If proven superior to standard care, the proposed intervention can be easily~     scaled-up and integrated into existing healthcare systems in resource-limited settings.~     Findings from this study will provide randomized trial evidence to inform HIV prevention~     program planners and implementers. This study will also provide further information on the~     feasibility of using mobile phone-based technology for public health interventions in~     resource-limited settings.~   "
123956|NCT01433172|"~     The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in~     combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to~     find out if the vaccine and the drugs can boost the immune system of these patients and how~     their immune system reacts, both before and after the vaccine treatment.~   "
123957|NCT01433159|"~     The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care~     in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury,~     measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.~   "
123958|NCT01433146|"~     Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity~     and influence Survival in Colorectal Cancer Patients~   "
123959|NCT01433133|"~     This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study.~     The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.~      All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex~     vivo transduced with genetic construct containing the gene for interferon)tissue implants~     intended to provide sustained production and delivery of therapeutic levels of INF for up to~     twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for~     a total of two years post INFRADURE Biopump implantation~   "
123960|NCT01433120|"~     Studies of the human gut microbiome have suggested that treatment or prevention aimed at the~     obese microbiome could influence the development of obesity-associated metabolic~     disturbances.~      The objective of this project is to explore if a dietary intervention in 60 obese women with~     the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the~     gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and~     to explore the interaction between the human genome and the gut microbiome.~      The study is based on the following hypotheses:~        -  Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed~          fibres will lower the metabolic risk profile in the intervention groups compared with~          placebo.~        -  The effect on the metabolic risk markers can be correlated with changes in the gut~          microbiota (measured in faeces).~      After completion of the dietary intervention, the participants are offered a 10-week weight~     reduction program. Those who participate in the weight-loss program are invited to an~     optional follow-up visit in connection with the last visit at the clinical dietician, for~     the purpose of exploring the effect of weight loss on the gut microbiota and~     obesity-associated metabolic disturbances.~   "
123961|NCT01433107|"~     This study will compare the efficacy and safety of a single dose of terbinafine film forming~     solution 1% with a single dose of placebo film forming solution in the treatment of tinea~     pedis.~   "
123962|NCT01433094|"~     Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders,~     with a high impact on disability and participation. Poor adherence to pharmacotherapy~     negatively impacts on the course and outcome of PSS.~      Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of~     relapse and readmission up to 5-time higher than in adherent patients. Falloon et al.~     developed a Psychoeducation Program (FPP) aimed at improving communication and~     problem-solving abilities in patients and their families. Past studies reported a~     statistically significant reduction of the risk of relapse in patients receiving the FPP,~     but did not take into account effects on adherence.~      Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients~     diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with~     another group exposed to a treatment with generic informative prospects on the disorders~     provided with same attendance frequency as the FPP (Generic Treatment - GT).~      Methods: 340 patients with PSS, from 10 participating units distributed in the territory of~     the Italian National Health System, will be enrolled, with allocation 1:1. The sample will~     be randomized into an exposed group (to FPP) and an unexposed group. Adherence will be~     assessed on a three-monthly basis with blood levels of the primary prescribed drug by High~     Pressure Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire,~     and concurrently with the administration of a 4-item interview, based on a modified version~     of the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method,~     followed by Log-rank test, defining as terminal events both the start of non-adherence~     and/or the first relapse or readmission episode. Intention-to-treat will be applied in~     considering the primary and secondary outcomes. Multiple imputations will be applied to~     integrate missing data.~      Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already~     in contact with a psychiatric service is 47%; effect size of psychosocial treatment on~     various outcomes, including relapse, readmission and adherence to drug is 0.48 of the~     standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce~     a change in the prevalence of non-adherence to drug in the exposed group with an effect size~     of 0.45 SD.~   "
123978|NCT01432886|"~     The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the~     tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and~     estimate the recommended dose.~   "
123963|NCT01433081|"~     A national survey has revealed that 80% of patients experienced pain after surgery and 86%~     of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend~     recovery room stay after surgery and it is also a common cause of unanticipated admissions~     which have important economic implications(2).More importantly, postoperative pain can lead~     to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications~     that might decrease postoperative pain is therefore highly desirable.~      Some medications such as lidocaine and ketamine have been proved to decrease postoperative~     pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still~     unknown if those medications can in fact lead to a better quality of recovery .~      Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate~     (NMDA) receptor(5). NMDA receptors have an important role on pain modulation (6). The use of~     Intraoperative magnesium in order to decrease postoperative pain had contradictory results~     in different studies. Some studies have shown a potential benefit of magnesium in decreasing~     postoperative pain (7,8) while others have not demonstrated any benefit (9,10).~      In the ambulatory setting, specifically, Tramer et al. did not find any improvement on~     postoperative pain after an Intraoperative dose of magnesium for patients undergoing~     ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction~     in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery~     (12).~      Even though, the reduction of postoperative opioid requirement has been used in many studies~     in the ambulatory literature, it has been recently questioned by some investigators~     (13).Patients might take more opioid medications but they may not necessarily develop opioid~     related side effects such as nausea and vomiting. A more global evaluation of the patient~     involving several aspects of recovery would be more significant.~      The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the~     quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a~     useful outcome measure to assess the impact on changes in health care delivery (15), but~     anesthesia studies underutilize this instrument.~      As more complex and painful procedures are being done in the ambulatory setting , the use of~     non-opioid strategies to control postoperative pain and to enhance quality of recovery will~     have even a greater role in the anesthetic management of patients. Magnesium has not been~     established as a potential adjuvant in ambulatory patients with conflicting results of~     previous investigators. The main objective of this study is to evaluate if the~     Intraoperative use of magnesium have the ability to improve postoperative quality of~     recovery in ambulatory patients.~   "
123964|NCT01433068|"~     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size~     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and~     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering~     surgery more feasible or easier and achieve better local control of the tumor.~      PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in~     the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.~   "
123965|NCT01433055|"~     Schizophrenia is a devastating and costly illness. One-third to one-half of people with~     schizophrenia do not respond to the most current drugs leaving clozapine as the best~     alternative for treatment. However, over 60% of people treated with clozapine continue to~     have persistent symptoms and cognitive impairments. Little data is available to support~     evidence-based recommendations to guide clinicians in treating these patients. Preliminary~     data has suggested that adjunct treatment with minocycline may offer robust symptom~     improvement in patients with schizophrenia, including those taking clozapine. Minocycline~     has had interesting effects; including suggesting it may have a significant role in~     treatment of neurologic and psychiatric disorders. Minocycline is currently available~     generically; its side effects are well-described and minimal. The proposed double-blind~     treatment study seeks to demonstrate that adjunctive minocycline offers patients superior~     efficacy for persistent positive symptoms, cognitive impairments, and/or other components of~     schizophrenia pathology. This knowledge could lead to the more effective treatment of~     patients with schizophrenia. The research itself may lead to a better understanding of the~     pathophysiology of positive symptoms and cognitive impairments, which could contribute to~     improved treatments in the future.~   "
123966|NCT01433042|"~     Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image~     quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of~     2-6 fps, which will create more images for evaluation, and therefore should improve~     diagnostic accuracy.~      Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small~     bowel disease.~      Preparation for procedure will include 12 hours fasting prior to the capsule ingestion~      Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear~     liquids 2 hours post ingestion, and eat 4 hours post ingestion.~      Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of~     capsule performance will be captured~   "
123967|NCT01433029|"~     The goal of this research study is to develop a method of rating videos of CAB procedures~     that will produce a reliable assessment of a cardiothoracic surgical trainee's technical~     proficiency. In addition, researchers also want to learn if using a video manual to train~     raters can help improve rater reliability.~   "
123968|NCT01433016|"~     The Exalenz clinical investigation is a multicenter, non-randomized, study of the~     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to~     evaluate the capability of the OBT measurement to differentiate between presence and absence~     of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver~     disease.~   "
123969|NCT01433003|"~     Thrombotic thrombocytopenia purpura / hemolytic uremic syndrome (TTP/HUS) is a rare,~     life-threatening disorder. TTP/HUS causes multiple blood clots to form, which prevents blood~     from reaching the brain and kidneys. TTP/HUS affects 3-5 people per million per year. Anyone~     can develop TTP/HUS, but it is most common among 30-40 year olds, and women are twice as~     likely as men to acquire the condition. TTP/HUS sometimes develops as a result of medication~     use, pregnancy or cancer; however, for the majority of patients (80%) the cause of TTP/HUS~     is unknown. In 1991, researchers discovered that plasma exchange was superior to plasma~     infusion in treating idiopathic TTP/HUS. During plasma exchange the patient's blood plasma~     is removed and replaced with healthy blood plasma. Without plasma exchange, the survival~     rate for TTP/HUS is extremely low, with fewer than 5% of patients surviving. Treating~     TTP/HUS with plasma exchange improved the survival rate to 80%. Although this represents a~     dramatic improvement, researchers are still searching for methods to improve survival. No~     major advances in treating TTP/HUS have occurred in the past 20 years. Recent research~     suggests that high-dose plasma exchange may improve the survival of TTP/HUS patients. The~     investigators will conduct a randomized controlled trial to test whether treating TTP/HUS~     patients with high-dose versus standard-dose plasma exchange improves the treatment~     response. The investigators will recruit 150 patients with TTP/HUS from 9 centres across~     Canada over three years. The investigators will evaluate whether high-dose plasma exchange~     improves the treatment response, survival, and whether it reduces the number and volume of~     plasma exchange procedures and duration of hospital stay.~   "
124008|NCT01432483|"~     The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK)~     to patients who are currently on therapy and who have no other suitable treatment options,~     where therapy is requested by their physician.~   "
123970|NCT01432990|"~     Until now, there's still no any strong evidence supported which is the best way to~     restoration walking ability in spinal cord injury. Most of the evidence suggest that, there~     is somehow better after gait rehabilitation for ASIA classification C and D but not improved~     walking ability for ASIA classification A and B. There is an RCT showed the evidence of~     repetitive locomotor training and physiotherapy could be improved walking and basic~     activities of daily living after stroke, these might be also really effect in SCI patients.~   "
123971|NCT01432977|"~     The aim of this study is to demonstrate that the association paracetamol / ondansetron is~     not as effective as the association paracetamol / droperidol in the treatment of pain in~     children following tonsillectomy. The secondary objectives are to compare opioid consumption~     (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two~     groups of patients in the first 24 hours after~   "
123972|NCT01432964|"~     In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases~     (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of~     orbital dimensions are severe complications causing enophthalmos, diplopia and visual acuity~     disturbance. To prevent such complications, immediate repair of orbital injuries with the~     restoration of normal anatomy is indicated in orbital floor fractures. With the help of~     biodegradable implants small and medium-sized defects are easily managed (Büchel 2005,~     Lieger 2010). In extensive fractures however, only calvarian bone and titanium mesh~     considered to provide a sufficient support of the orbital content.~      Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital~     lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh~     on the other hand is always available and easier to apply. There are however important~     requirements for these meshes, such as biocompatibility, excellent stability, optimal~     adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh~     featuring a low profile. In order to regain normal function, normal anatomy has to be~     re-established. It therefore seemed reasonable to assess an implant, which would facilitate~     orbital reconstruction without disturbing normal anatomy by its size, profile height or~     properties.~      The purpose of this study was to assess the use and accuracy of the low profile titanium~     mesh for primary internal orbital reconstruction.~   "
123973|NCT01432951|"~     The purpose of this study is to assess the pharmacokinetics of enzastaurin and its~     metabolites in native Chinese patients with advanced and/or metastatic solid tumors or~     lymphoma. Information about any side effects that may occur will also be collected.~     Treatment of disease is not the main purpose of the study.~      This is a Phase 1 study of enzastaurin in native Chinese patients with advanced and/or~     metastatic solid tumors or lymphoma. Patients will receive daily doses of enzastaurin for 14~     days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Patients may~     be allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an~     opportunity for a patient's oncologist to assess the potential benefit of the patient~     continuing to receive enzastaurin in the safety extension phase. There is no planned~     duration for the extension phase; patients are allowed to continue receiving enzastaurin~     until disease progression or other reason for discontinuation as per the investigator's~     assessment.~   "
123974|NCT01432938|"~     Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this~     study is to determine if dulaglutide (LY2189265) affects how warfarin works. The study~     involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide +~     warfarin) separated by a minimum washout period of 24 days. In Treatment 1, the participant~     will receive 10 milligrams (mg) of warfarin on Day 1. In Treatment 2, the participant will~     receive a 1.5-mg dose of dulaglutide (LY2189265) as an injection on Day 1 and then a 10 mg~     dose of warfarin on Day 3. Participants will be randomly assigned into different treatment~     sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2.~     Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.~   "
123975|NCT01432925|"~     SUMMARY~      Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic~     in West Africa. It often leads to functional limitations. Treatment was by extensive~     surgery, until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and~     streptomycin was added. Observation of Buruli ulcer lesions of limited size during~     antibiotic treatment showed that during treatment there is a paradoxical increase of the~     lesion, with a decrease of the lesion after week 14. Current WHO protocols advise to decide~     whether surgery is needed four weeks after the start of antibiotics. This might be too early~     in the healing process. The investigators hypothesize that delay in surgery is safe, and~     that it results in a reduction of the number of surgical interventions.~      Objectives:~      Primary Objective of this study is to compare the need for surgical treatment in standard~     timing of surgery at the end of eight weeks antimicrobial treatment with a policy to~     postpone surgical treatment until week 14.~      Secondary Objectives are to study whether postponing surgery leads to less extensive surgery~     and a change in frequency of functional limitations;~      Study design:~      Patients will be randomized for surgery at week 8 after start of antibiotic treatment and~     week 14 after start of treatment. Reasons for treating doctors to decide to intervene with~     surgery will be according to current clinical practice and will be clearly defined in this~     protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All~     patients will be followed and lesional size using acetate sheet recordings will be used~     during follow-up.~      Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by~     diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada,~     Benin. Patients who are pregnant, have a contraindication for general anaesthesia and~     children below three years old will be excluded. 130 Patients in each treatment arm will be~     included to detect a difference in percentage of patients needing surgery of 20 percent.~      Main study parameters/endpoints: Primary outcome measure is the number of patients healed~     without surgery. Secondary outcome measures are the extent of surgery by measurement of~     lesional size, functional limitations after the end of treatment and one year after the~     start of treatment and the duration of admission.~   "
123976|NCT01432912|"~     The purpose of the study is to see if a short seminar educating physicians about smoking~     cessation counselling will effectively improve their smoking counselling cessation~     practices.~   "
123977|NCT01432899|"~     Background:~      - Childhood-onset dystonia is caused by a brain injury. It causes muscle contractions and~     twisting movements that the person with dystonia cannot control. The term hemidystonia is~     used when only one side of the body is affected. When dystonia starts during childhood, the~     brain and nerves may not develop normally. People with hemidystonia can become disabled~     because of the unwanted postures and twisting that dystonia causes. More research is needed~     to determine how dystonia affects brain development.~      Objectives:~      - To study brain function in people with hemidystonia.~      Eligibility:~        -  Individuals between 18 and 40 years of age who developed hemidystonia before age 13.~          Only one wrist may be affected by hemidystonia, and participants must have at least~          some movement in that wrist.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study requires five visits to the NIH Clinical Center: a screening visit and four~          study visits. Each visit will last up to 3 hours. Visits will be scheduled about once a~          week. The study procedures may be done in any order.~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have the following tests:~        -  Brain magnetic resonance imaging scan. During the scan, participants will be asked to~          move their hand at the wrist when they hear a tone.~        -  Motor tests of arm movement, balance, and walking. These tests may also examine nerve~          development and muscle tone.~        -  Two transcranial magnetic stimulation sessions to study the electrical activity of the~          muscles and brain. These sessions may also involve sensory tests. Participants will~          have hearing tests before the first session and after the second session.~        -  No treatment for hemidystonia will be provided as part of this study.~   "
123979|NCT01432873|"~     Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of~     mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc~     sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis~     and positive effects are seen. Our purpose in this double blinded randomized study is to~     evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia~     (AML) & acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide~     before Hematopoietic stem cell transplantation (HSCT).~   "
123980|NCT01432860|"~     The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree~     relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma~     in comparison to the general public. Skin self-examination (SSE) with the assistance of a~     partner by these individuals could improve survival. If effective, the workbook tested in~     this proposal could be distributed to people at risk of developing melanoma by large scale~     means in physicians office.~   "
123981|NCT01432847|"~     Background:~      - Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and~     Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the~     back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.~     However, cells collected from hair follicles, skin, and blood can be used for research.~     Researchers want to collect cells from people with Best disease, L-ORD, and AMD, and compare~     their cells with those of healthy volunteers.~      Objectives:~      - To collect hair, skin, and blood samples to study three eye diseases that affect the~     retina: Best disease, L-ORD, and AMD.~      Eligibility:~        -  Individuals at least 18 years of age who have Best disease, L-ORD, or AMD in at least~          one eye.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  The study requires one visit to the National Eye Institute.~        -  Participants will be screened with a medical and eye disease history. They will also~          have an eye exam.~        -  Participants will provide a hair sample, a blood sample, and a skin biopsy. The hair~          will be collected from the back of the head, and the skin will be collected from the~          inside of the upper arm.~   "
123982|NCT01432834|"~     The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and~     the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism~     faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy~     (PRK).~   "
123983|NCT01432821|"~     The objective of the present study is to assess dopaminergic reactivity with behavioural~     markers (i.e. yawning and blinking) in patients with idiopathic generalized epilepsy~     compared to matched healthy controls, after injection of either low dose of apomorphine or~     placebo.~      Other parameters will be recorded: biochemical (prolactin, GH) and neurophysiological~     (Spike-Waves Discharge: SWD rating). Safety parameters will be recorded to assess tolerance.~   "
123984|NCT01432795|"~     Medical compression stockings are highly effective in the prevention, treatment, and~     secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome.~     Non-adherence to the prescribed compression treatment concerns approximately 40% of~     patients. Elderly patients are often unable to handle stockings in order to put them on~     properly in the morning and to undress in the evening. Gliding aids and stocking butlers~     are two types of tools to facilitate the dressing manoeuvre with medical stockings.~      The present study evaluates four different gliding aids and two different stocking butlers~     to put on three different types of compression stockings. The study is conducted with forty~     consenting subjects with advanced chronic venous insufficiency.~   "
123985|NCT01432782|"~     This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically~     in the distal esophagus, on symptoms and manometry pattern in patients with diffuse~     esophageal spasm.~   "
123986|NCT01432769|"~     Effect of enteral nutrition in the outcome of patients has the objective to determine the~     effect of implementing a nutritional support protocol on the outcome of cardiovascular~     surgery patients, the main justification of the study its the prevalence of malnutrition~     over the hospitalized patients and the way this complication influence the treatment~     efficacy, the risk of complications over these patients, the costs, the prognosis, mortality~     and hospital stay.~      This study will be a control clinical trial, randomized and double blind.~   "
123987|NCT01432756|"~     The investigators hypothesize that participants in the worksite parenting program~     intervention will show significantly better parent-child communication than will~     participants in the no-treatment (wait-list) control group.~   "
123988|NCT01432743|"~     Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of~     ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in~     catheter ablation of AF. Integration of a previously acquired image of the left atrium into~     the electroanatomical (EA) map offers several potential advantages, including visualisation~     of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved~     results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX~     Fusion (SJM, etc). Although both systems have been independently validated, their clinical~     utility has not previously been directly compared in a randomised trial~   "
123989|NCT01432730|"~     This is a randomised, double-blind, placebo-controlled, crossover, single centre study of~     AF-219 in subjects with idiopathic chronic cough designed to evaluate the effectiveness of~     AF-219 in reducing daytime objective cough frequency.~   "
123990|NCT01432717|"~     The purpose of this study is to find out whether ACE-536 can be safely given to patients.~     This study will also look to see if ACE-536 increases red blood cells, the cells that carry~     oxygen in the body.~   "
123991|NCT01432704|"~     This is a one-year multi-centre, double blind, placebo controlled, randomized trial~     investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b~     for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with~     interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral~     colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin~     D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that~     vitamin D suppresses clinical and MRI activity of MS.~   "
123992|NCT01432691|"~     This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint~     replacement.~   "
123993|NCT01432678|"~     The purpose of this study is to evaluate level of vitamin D in pediatric asthma and~     relationship between vitamin D and level control of asthma.~   "
123994|NCT01432665|"~     The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week~     baseline establishment period, 16 week treatment period and a follow up period for a total~     of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study~     investigates the effective dose of Lybrido in increasing the number of satisfactory sexual~     episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual~     desire disorder and low sensitivity for sexual cues (30 subjects per group).~   "
123995|NCT01432652|"~     The purpose of this study is to determine the incidence of aspirin resistance in the~     population of vascular surgery patients; and to evaluate the changes in the efficacy of~     aspirin in the first five postoperative days.~   "
123996|NCT01432639|"~     The main purposes of this study is to analyze, in a randomized controlled trial, the effects~     of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial~     function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on~     arterial stiffness in coronary artery disease patients (CAD). Additionally, the~     investigators aim to analyze the (v) contribution of age and the changes in traditional risk~     factors to the modification of the endothelial dysfunction and inflammation, and (vi) the~     contribution of the changes in inflammatory and endothelial function biomarkers to the~     modification of autonomic function and arterial stiffness.~      The investigators hypothesize that exercise training will improve the autonomic function,~     arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients~     even in the absence of significant changes in traditional risk factors. Thus, the~     investigators expect with the present study to promote, develop and expand the knowledge in~     this field by assessing the impact of exercise on a pool of markers that provide a wide~     picture of the pathophysiological processes underlying CAD.~   "
123997|NCT01432626|"~     Objective: The objective of this pilot study is to characterize the cardiac uptake patterns~     of I-123 mIBG in stress-induced (Takotsubo's) cardiomyopathy.~      Hypothesis: Perturbations in sympathetic innervation are the underlying pathogenesis of~     stress induced cardiomyopathy and will result in abnormalities in I-123 mIBG cardiac~     imaging. Thus, planar and SPECT I-123 MIBG imaging will provide insight into the~     pathogenesis of stress-induced cardiomyopathy, and may lead to the development of more~     specific diagnostic criteria.~      Study design: This proposal is for a prospective pilot study to characterize perturbations~     in cardiac sympathetic innervation in patients with stress induced cardiomyopathy by~     performing planar and SPECT I-123 MIBG imaging during the acute presentation and after~     recovery of LV function.~   "
123998|NCT01432613|"~     Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses.~     An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high~     and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance~     imaging) in departments managing IIM is common. In absence of recommendations fixing their~     place in the diagnostic phase, the practices observed are extremely heterogeneous. This~     practices diversity well reflects the lack of data in the literature, making it impossible~     to appreciate the real contribution of this test. The main aim of this interventional study~     is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity,~     predictive positive value and predictive negative value) for patients who are suspected to~     suffer from IIM.~   "
123999|NCT01432600|"~     The main purpose of this study is to see whether pomalidomide can help people with myeloma.~     Researchers also want to find out if pomalidomide is safe and tolerable.~   "
124000|NCT01432587|"~     An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for~     the study can no longer participate or receive treatment by diflunisal; and patients, who~     have participated in the trial can not continue their treatment. The investigators want to~     continue to monitor the effect of the drug on transthyretin (TTR) amyloidosis in an open~     label observational study.~      Primary endpoint will be a composite score of the manifestations of the disease (Kumamoto~     scale) and secondary end points will be measurements of neurological impairment, heart~     involvement and nutritional status.~   "
124001|NCT01432574|"~     The purpose of this study is to test the effectiveness of the research study vaccine,~     Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human~     Papillomavirus [HPV] infection in men (HIM) Study.~   "
124002|NCT01432561|"~     In order to meet FDA standards of safety and efficacy reporting for most new drugs,~     food-effect bioavailability (the impact that the presence of food in the digestive tract has~     on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the~     site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of~     the rare disease cystinosis that became available in 1994, but there is inadequate knowledge~     of the food-effect on this drug's bioavailability. This study aims to investigate how food~     affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.~   "
124003|NCT01432548|"~     Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause~     ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver~     disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion)~     causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the~     ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can~     lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to~     protect the liver parenchyma during liver resection consists of an initial flow clamping for~     10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad~     clamping during transection.~   "
124004|NCT01432535|"~     This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b~     (Sylatron®) in healthy participants to that in participants with moderate to severe~     impairment of kidney function.~   "
124005|NCT01432522|"~     This study is a preliminary report of pharmacokinetic data of epinephrine administered via~     intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.~   "
124006|NCT01432509|"~     The purpose of this study is to identify in prediabetic subjects, physiopathological changes~     involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type~     2 diabetes risk in this population.~   "
124007|NCT01432496|"~     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg~     produces better postoperative pain control than Saline nebulization after laparoscopic~     colectomy.~   "
124009|NCT01432470|"~     Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning,~     itching or discomfort, which often make sex to become difficult or painful. These symptoms~     combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue~     of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In~     addition, vaginal atrophy is associated with an increased pH, which creates an environment~     more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and~     cytological examination demonstrate increased number of the basal and parabasal cells and~     reduced number of superficial cells.~      Estrogen treatment either as hormone replacement therapy or topical application is a common~     treatment for vaginal atrophy. However, some women experience adverse reactions such as~     uterine bleeding, perineal pain and breast pain and many women are also reluctant to use~     estrogens due to a general negative view to this topic in the society.~      Oxytocin is a peptide hormone, which is normally released into the circulation via the~     pituitary. The most well known effects of oxytocin are its roles in female reproduction such~     as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown~     to exert positive effects on the proliferation of human vaginal mucosal cells from~     postmenopausal women.~      Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation,~     topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal~     atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from~     vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was~     applied daily for seven days. The results indicated that for subjects receiving topical~     oxytocin the vaginal atrophy assessed by histological examination was reversed after~     treatment. A similar effect was not seen in the placebo group, which indicated a difference~     between placebo and active treatment. However, the limited number of exposed subjects in~     this pilot study necessitates a larger study in order to generate conclusive proof of~     concept data for the effects of oxytocin on vaginal atrophy.~      Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal~     women are left without an effective remedy. Hence, there is a need for alternative~     non-estrogenic treatments of this indication. The present study is aiming to investigate the~     efficacy of topical oxytocin in the treatment of vaginal atrophy.~      The main objective of this study is to investigate if topical oxytocin can reverse vaginal~     atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in~     postmenopausal women after 12 weeks of treatment as compared to placebo.~   "
124010|NCT01432457|"~     A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of~     desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with~     major depressive disorder.~   "
124011|NCT01432444|"~     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic~     patients treated with oral antipsychotics to prospective hospitalization rates of these~     patients treated with IM depot aripiprazole.~   "
124012|NCT01432431|"~     This clinical trial studies spiritual care in improving quality of life of patients,~     caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its~     treatment has on patients, caregivers and hospital staff.~   "
124013|NCT01432418|"~     This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the~     hypothesis that wheelchair skills training (using a systematic training program called the~     Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered~     wheelchair users. A second objective is to assess the effects of age, sex, training centre,~     and participant experience on outcomes, assessing the retention of benefits and assessing~     the impact of training on other important outcomes.~   "
124014|NCT01432405|"~     The purpose of this study is to examine the effect of exenatide, an anti-diabetes~     medication, on liver fat and blood levels of proteins that influence liver fat.~   "
124015|NCT01432392|"~     The purpose of this study is to evaluate the impact of gastroesophageal reflux disease~     (GERD) treatment in primary care setting on symptom control and daily life in symptomatic~     GERD patients, using both GERD questionnaire and clinical symptoms assessment~   "
124016|NCT01432379|"~     This is a post authorization observational study to monitor the utilization practices and~     describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of~     headaches in adult patients with chronic migraine.~   "
124017|NCT01432366|"~     It can be assumed that there is a link between what the patient feels and thinks about his~     medication and objective measures of disease activity and safety.~   "
124018|NCT01432353|"~     This multicenter, open-label, dose-escalating study will assess the safety and efficacy of~     DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will~     receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients~     exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up~     to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or~     unacceptable toxicity occurs.~   "
124019|NCT01432340|"~     Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal~     influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each~     year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality~     worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza~     season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance~     data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed~     countries. However, little is know about the effectiveness of influenza vaccine in the~     developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less~     than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP)~     under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe~     acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya,~     Lwak (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a~     three-year influenza vaccine effectiveness study using the commercially available southern~     hemisphere seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and~     for 2011 and 2012. The study will evaluate the effectiveness of the vaccine in preventing~     laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and~     secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing~     children with influenza vaccine will decrease influenza-associated acute respiratory~     infections among children and may reduce the number of non-specific acute respiratory~     infections in vaccinated children and their household contacts.~   "
124020|NCT01432327|"~     The aim of the study is to assess an increase of daily physical activity from electronic~     self-monitoring, to compare these values to the 10.000 step program, and to compare with~     real-time feedback with and without guidance from a Personal Coach.~   "
124021|NCT01432314|"~     In this study, the investigators are to prospectively evaluate patient's survival, tumor~     response, and safety of RT followed by TACE in Child A patients with unilobar portal vein~     invasion.~   "
124022|NCT01432301|"~     The purpose of this study is to provide emergency treatment of adult and pediatric patients:~        -  Following a fluorouracil or capecitabine overdose regardless of the presence of~          symptoms or~        -  Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or~          central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g.,~          gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of~          fluorouracil or capecitabine administration.~   "
124023|NCT01432288|"~     This study will measure resting state network central nervous system activity by functional~     magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.~      Hypothesis 1. Because they are different sensory systems, there will be different patterns~     of Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS)~     activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).~      Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial~     expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ~     for LKM+ vs. LKM- stimulation for both visual and tactile interventions.~      Hypothesis 3. Because there is greater opportunity to detect signals from two sensory~     systems than one, the differences between CNS MNS and RSN activity patterns for LKM+ and~     LKM- will be greater for combined visual + tactile than for either visual or tactile~     stimulation alone.~   "
124024|NCT01432275|"~     The aim of this study is to evaluate user preference and ease of use of the FreeStyle~     InsuLinx system, compared to current methodology, when used at home by subjects with~     diabetes.~      Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with~     comparator meters.~   "
124025|NCT01432262|"~     The purpose of this study will be to assess the safety, tolerability, and immunogenicity of~     13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50~     years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.~   "
124026|NCT01432249|"~     Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of~     Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication~     approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of~     new indication should be provided at minimum 600 subjects administered in the setting of~     routine practice during the initial 4 years after new indication approved.~   "
124027|NCT01432236|"~     The intent of this study is to identify and treat fibromyalgia subjects with comorbid~     depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI~     (selective norepinephrine reuptake inhibitor) primarily for their depression and to~     determine whether pregabalin demonstrates improvement relative to placebo in improving pain~     associated with fibromyalgia.~   "
124028|NCT01432223|"~     The purpose of this study is to evaluate the efficacy in terms of the pathological complete~     response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based~     regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable~     breast cancer.~   "
124029|NCT01432210|"~     Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and~     vegetables is not active and must be converted to the active form in the human body.~     However, information on the ability of humans to absorb and convert vitamin A to the active~     form is still lacking. In this study, the investigators will observe the absorption and~     conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from~     avocado fruit) and a meal without fat. The investigators will also test whether eating these~     foods might protect the blood against damage that could lead to heart disease.~   "
124030|NCT01432197|"~     The aim of this study is to investigate the effect of occupational therapy, in shape of~     activities of daily living, for cancer patients.~   "
124031|NCT01432184|"~     Using the brain and the heart as index organs, perioperative interventions to optimize~     cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing~     cardiac surgery should have a beneficial systemic effect for enhancing global tissue~     perfusion and improve outcomes.~   "
124032|NCT01432171|"~     The goal of this clinical research study is to learn if an antiepileptic (anti-seizure)~     treatment will prevent seizures in patients with brain tumors who have not yet had a~     seizure. Anti-seizure drugs are designed to decrease abnormal electrical activity in the~     brain that plays a role in developing seizures.~      In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be~     compared to a placebo.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
124033|NCT01432158|"~     This is an open-label phase III clinical trial. The purpose of this trial is to investigate~     in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate~     vaccine, compared to Pneumovax-II, a pneumococcal plain polysaccharide vaccine. With their~     consent, healthy adults (n=2 in each group) aged over 18 years who have not received any~     pneumococcal vaccine in the past will receive either vaccine at their first visit. Blood~     will be taken before vaccination and at day 0,1,2,4,6,8,10,12,14,16,18,20,23,26,30,35 as~     well as 2,6 and 12 months following vaccination. With specific consent, a small volume of~     blood will be used to store DNA and RNA for analysis of the genetic associations with immune~     responses and adverse reactions to vaccines as well as the RNA expression following a~     vaccination. Serum or plasma will be used to assess antibody level and available whole blood~     will be used for B cell assays and to examine immunoglobulin gene usage in B cells.~   "
124034|NCT01432145|"~     This study will evaluate the efficacy and safety of 6MP in combination with methotrexate in~     patients with breast or ovarian cancer who are known to have a BRCA mutation. 6MP is used~     instead of 6TG as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine~     nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination~     with 6MP as it promotes the formation of thioguanine nucleotides.~   "
124035|NCT01432132|"~     The goal of this research study is to understand how patients adjust to appearance and body~     image changes after surgery for head and neck cancer.~   "
124036|NCT01432119|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and~     cetuximab. Some participants will also take erlotinib with this combination.~      Yttrium-90 microspheres are designed to treat cancer that has spread to the liver.~     SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may~     cause the tumor cells to die.~      Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor~     receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop~     tumors from growing.~   "
124544|NCT01425450|"~     The study aims to:~        -  study the safety of the drug (HF1020) in healthy male adults~        -  study how well the study drug (HF1020) is tolerated in healthy male adults~        -  find the maximum dose that is tolerated in healthy male adults~   "
124037|NCT01432106|"~     Study purpose: African Americans with hypertension and markers of metabolic syndrome (small~     elevations in blood glucose, triglycerides and or weight) are at a high risk of~     cardiovascular (heart and blood vessel) problems. There is a circulating factor called~     angiotensin II that increases risk and may be more important in African Americans who have~     up to 20 times greater risk of losing kidney function and requiring dialysis. Research~     Investigators, including those at the University of Michigan, found one drug (Ramipril) that~     blocks angiotensin II effects significantly and improves kidney function in African~     Americans.~      The purpose of The SAAVE Study is to determine whether the combination of two new blockers~     (Valsartan and Aliskiren) of angiotensin II, are better able to lower blood pressure, also~     improve some of the risk factors for cardiovascular problems and provide greater protection~     to the heart and kidneys.~   "
124038|NCT01432093|"~     Most people develop high blood sugars following liver transplant that requires treatment~     with insulin in the hospital, even if they don't have diabetes, due to stress and use of~     steroid medications. High blood sugar levels can be treated with a hormone that the body~     makes called insulin. This study is being done to determine if maintaining normal blood~     sugar levels after transplant for as long as needed while in the hospital results in a~     lesser incidence of death, infections, transplanted liver rejection or failure or need for~     rehospitalization within 90 days after transplant.~   "
124039|NCT01432080|"~     For many patients with blood cancers, stem cell transplantation from a family member or from~     an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of~     patients develop chronic lung disease after the transplant, which substantially increases~     the risk of death in the long-term. Currently, patients with transplant-related lung disease~     are treated with some combination of steroids and other immunosuppressant drugs, but only~     about 1 out of 5 improve.~      The importance of our study is that the investigators aim to prevent the development of~     transplant-related chronic lung disease in the first place. Because a strong risk factor for~     such chronic lung disease is a prior viral respiratory tract infection, the investigators~     think there is a window of opportunity to intervene. As soon as cold and flu symptoms~     start, the investigators will treat patients with a combination of drugs aimed at~     eliminating damaging immune responses triggered by the virus. In the absence of such~     treatment, the investigators believe these lung-damaging immune responses would persist even~     after the virus disappears. Our hope is that preventive treatment might avoid the~     development of chronic lung disease, and this would substantially increase long-term~     survival in our transplant patients.~      This is a pilot study. Once feasibility is established, the investigators will seek to~     expand this study into a definitive clinical trial.~   "
124040|NCT01432067|"~     The investigators will propose to older cancer patients with good prognosis (curative care)~     a randomized trial of adapted physical activity during one year. To increase generalisation~     of the intervention the investigators intend to compare the PNNS advices (the French~     National Nutrition and Health Program) to a program targeted on the own capacities of each~     patient.~   "
124041|NCT01432054|"~     The objective of this study is to create a Human Tissue Repository to be used as a resource~     for future tissue repair research at KCI USA, Inc.~   "
124042|NCT01432041|"~     Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention~     program which was conducted in the waiting area of a level 1 pediatric trauma center. A~     computer kiosk was used to randomly assign participants to study groups, collect baseline~     data and generate tailored reports based on responses to assessment items. An intervention~     group received a personalized and stage-tailored safety report and a control group received~     a personalized, but otherwise generic report on other child health topics. Telephone~     follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home~     visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up~     interview. The study aimed to increase knowledge, self reported and observed safety~     behaviors.~   "
124043|NCT01432028|"~     This is cross-over, randomized clinical trial, with objective to evaluate the effects of~     low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers~     (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on~     anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women~     and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms~      Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment~      The investigators hypothesis is that a different genotypes in the receptor estrogen gene and~     FTO may have an influences on treatment response in metabolic markers and cardiovascular~     risk~   "
124044|NCT01432015|"~     Nausea and vomiting are two of the more concerning adverse outcomes associated with~     chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer~     patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with~     carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and~     vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and~     sustaining a cancer patient's quality of life.~   "
124045|NCT01432002|"~     The purpose of the study is:~        -  to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast~          cancer in order to define the size and location of the primary tumor, as well as~          axillary, supraclavicular and internal mammary lymph nodes.~        -  to apply the imaging results to the simulation and the radiation treatment planning and~          partial breast for 3-D radiation treatment and partial breast irradiation with~          intensity modulated radiation treatment (IMRT).~   "
124046|NCT01431989|"~     This study is prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the~     reference or the test formulation, according to the randomization list, under fasting~     conditions, in order to evaluate if the reference and test formulations are bioequivalent.~   "
124055|NCT01431872|"~     The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to~     peak, then decrease gradually as estrogens reach a new lower, but steady level. The~     investigators also believe that the peak in DKK1 will initiated a wave of stem cell~     diversion from the osteoblastogenic pathway to the adipogenic pathway.~      The investigators will conduct a longitudinal cohort study of post menopausal women with~     hormone-responsive breast cancer that will be treated AIs. The study will observe~     anthromorphic and serum marker changes during the first year of their treatment.~   "
124047|NCT01431976|"~     This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety~     of lamotrigine monotherapy on newly diagnosed typical absence seizure in children and~     adolescents in Japan and South Korea.~      The study period is composed the baseline, fixed escalation phase, escalation phase,~     maintenance phase, taper phase, and post study examination. During the fixed escalation~     phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to~     2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the~     clinic once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6~     mg/kg/day up to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until~     patients are confirmed to be seizure-free by HV tests for clinical signs. After seizure free~     is confirmed by HV-clinical signs, the dose is increased by one level and HV-EEG~     (electroencephalography) test (first test) is assessed at the next visit. If seizure free is~     observed by HV-EEG, the same dose is administered. Thereafter, HV-EEG (second test) is~     assessed at the next visit and if seizure free is confirmed again, the subjects enter the~     12-week maintenance phase. During the maintenance phase, patients visit the clinic once~     every 4 weeks. The dose can be adjusted as necessary within the range of 1.2 to 10.2~     mg/kg/day or 400 mg/day (whichever was less) taking into account the status of seizures and~     the safety. The investigational product is administered once daily (in the evening).~     However, if the number of tablets is large, twice-daily administration (in the morning and~     evening) is also allowed. After the completion of maintenance phase, subjects who have~     responded to lamotrigine without tolerability issues are eligible to enter the extension~     phase of the study if clinically indicated.~   "
124048|NCT01431963|"~     This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to~     evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed~     epilepsy and those with recurrent epilepsy (currently untreated).~      The study is composed of baseline, escalation phase, maintenance phase, taper phase and post~     study examination. During the escalation phase, the investigational product is administered~     orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2~     weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks.~     However, the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it~     is confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can~     be gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As~     a rule, lamotrigine should be administered once daily (in the evening), but the dose~     exceeding 200 mg/day can be administered in two divided doses (in the morning and evening).~     After the completion of maintenance phase, Japanese subjects who have responded to~     lamotrigine without tolerability issues are eligible to enter an extension phase of the~     study if indicated, until either approval of this indication (monotherapy in epilepsy) or~     after 24 months after LSLV (Last Subject's Last Visit) of the maintenance phase, whichever~     is sooner.~   "
124049|NCT01431950|"~     A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two~     doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and~     adolescents currently receiving mid to high strength inhaled corticosteroids.~   "
124050|NCT01431937|"~     The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     repeat ascending doses of GSK2018682. The study will also provide further evidence of the~     potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on~     Absolute Lymphocyte Counts (ALC).~   "
124051|NCT01431924|"~     This is an observational retrospective analysis of linked pharmacy and medical claims data~     from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States~     (US) healthcare claims database that is representative of the non-elderly,~     insurance-carrying population, The total population is 35.4 million. The average length of~     follow-up is 2.7 years mean (2.2 years median).~      Subjects will be identified in the database that have at least one ICD-9 diagnostic code~     (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the~     index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids.~     Subjects will be followed in the database until they have the event of interest~     (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or~     combination of asthma-related emergency department/hospitalization or asthma-related~     emergency department/hospitalization/oral corticosteroids) or until they are lost to follow~     up whichever comes first. Subjects can be censored if they leave the database, have the~     event of interest, or are dispensed another asthma controller other than the medication of~     interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical~     models adjusting for differences in baseline (pre-index) asthma and patient demographics~     will be used to compare asthma events.~   "
124052|NCT01431911|"~     The timing of initiating short-term treatment for COPD exacerbations with oral~     corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of~     exacerbations with early initiation of exacerbation therapy having a faster symptom recovery~     compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are~     crucial for immediate exacerbation therapy, maintenance therapy with controller medications~     for COPD has been recommended to reduce the risk of future exacerbations. The initiation of~     maintenance therapy after a COPD exacerbation has been shown to be beneficial in the~     reduction of risk of future exacerbations. However, there is a lack of information on~     whether the timing of this initiation influences the risk of future exacerbations. The~     following study evaluates the impact of early versus delayed initiation of controller~     medication therapy for maintenance treatment following a COPD-related exacerbation on~     outcomes of future exacerbations and costs in patients with COPD.~   "
124053|NCT01431898|"~     This is a research study to evaluate the safety, tolerability and anti-viral activity of~     GS-9669 in patients with Hepatitis C infection.~   "
124054|NCT01431885|"~     Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical~     length to diagnose preterm labor can result in improved outcomes compared to traditional~     diagnosis based on digital examination to measure cervical change.~   "
124068|NCT01431703|"~     It exists a learning curve in using NBI with magnification to differentiating colorectal~     lesions.~   "
124289|NCT01428804|"~     The purpose of the study is to investigate the effect of tDCS applied at the anodic left~     DLPFC of patients with resistant depression compared to patients treated with conventional~     therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in~     resistant depression.~   "
124056|NCT01431859|"~     Birch pollen allergy is increasingly common. It causes asthma and early season hay fever.~     This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many~     patients with birch allergy get an itchy and/or swollen mouth when they eat fresh fruit~     (apples, pears, peaches, plums etc). Some fruit proteins have a similar structure to birch~     pollen; because of this the body recognises these proteins too causing the immune system to~     respond. This response causes symptoms of itch and swelling inside the mouth and throat. the~     investigators want to find out whether it is possible to get rid of the fruit-induced~     symptoms by using a desensitisation procedure that has been developed for treating the kind~     of hay fever that is caused by birch pollen. Desensitisation involves giving a small~     injection of pollen just under the skin and gradually increasing the amount each week. This~     allows the body to build up a tolerance to the injected protein. When the pollen is then~     encountered in real life the immune system reacts less vigorously so symptoms are less~     severe. This treatment does reduce hay fever symptoms. Our study aims to find out if this~     tolerance is transferred to the fruit proteins enabling patients to eat apples with minimal~     symptoms. Patients will be given apple to eat in a hidden form before treatment and their~     response assessed. They will then receive either active or dummy pollen injections before~     birch pollen season. A few months after completing these injections they will have another~     disguised apple test to see whether their symptoms are any better. If symptoms have improved~     with treatment then this therapy could be offered to patients in the future. This would~     allow them to eat fresh fruit without worrying about unpleasant symptoms and improve their~     hay fever symptoms.~   "
124057|NCT01431846|"~     The study had three parts:~      Part 1: Patients (or their home caretakers) who live outside of Denver and receive their~     primary care at a location other than the Denver VAMC were interviewed after their~     discharge. The interview covered the patient's perspective about the transition of their~     medical care from the Denver VA to their primary care facility.~      Part 2: Primary care providers from the VA facilities that refer patients to the Denver VA~     were interviewed regarding their opinions of transition process from the Denver VA back to~     the primary care VA facilities.~      Part 3: The data from the above interviews were used to develop an intervention to improve~     the transition process from the Denver VA back to the primary care VA facilities.~   "
124058|NCT01431833|"~     Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic~     impairment versus matched control subjects with normal hepatic function.~   "
124059|NCT01431820|"~     The purpose of this study is to determine the safety and efficacy of a topical antifungal~     formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of~     the toenails.~   "
124060|NCT01431807|"~     To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic~     patients.~   "
124061|NCT01431794|"~     This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine~     and nab-paclitaxel with an oral hedgehog inhibitor LDE225. The objective is to assess~     tolerability and the resection rate of patients with borderline resectable pancreatic~     adenocarcinoma who use this treatment.~   "
124062|NCT01431781|"~     Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde~     Cholangiopancreatography), the incidence rate is 5&-10%, how to prevent PEP and~     hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas~     treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP~     Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given~     common treatment, the other uses somatostatin in the base of common treatment.~   "
124063|NCT01431768|"~     This is a open label, prospective, pair comparison, randomised, multi-centre trial. The~     primary aim of this study to is to clinically validate the sensitivity and specificity of~     the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available~     rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for~     identifying Influenza A infection Polymerase Chain Reaction (PCR).~      The secondary aim is to clinically validate the sensitivity and specificity of the Respirio~     Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.~   "
124064|NCT01431755|"~     The objectives of this study are to evaluate the pain-relieving effect and safety of adding~     lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained.~     The study products will be administered in the cheek.~   "
124065|NCT01431742|"~     This is an open label study of up to approximately 52 weeks duration to assess the safety~     and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low~     back pain.~      BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine~     hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic~     opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled~     substance in the United States.~   "
124066|NCT01431729|"~     Although, oral mucositis has been studied for many years, no available treatment has been~     shown to be effective in preventing or treating mucositis. Based on the observations that~     honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial~     and wound healing effects, the present study aims at evaluation of the effect of topical~     application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as~     natural products, in treatment of chemotherapy-induced oral mucositis in children with acute~     lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which~     eligible patients were randomly assigned into three equal treatment groups. Group 1 received~     15 gm honey applied topically to the affected oral mucosa three times daily. Group 2~     received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied~     topically to the oral mucosa three times daily. Group 3 served as control and received a~     7.5% benzocaine gel applied to the areas of ulcers three times daily.~   "
124067|NCT01431716|"~     This study is investigating the effect of switching from Flolan® to Epoprostenol for~     Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated~     with Flolan®. For this purpose patients being treated for at least 12 months with Flolan®~     will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these~     90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated~     patients. This 90 follow-up will provide clinical evidence on the safety, tolerability,~     efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients~     with pulmonary arterial hypertension.~   "
124069|NCT01431690|"~     The primary objective of this study is to determine the effect of Epanova® on the~     pharmacokinetic and anticoagulant activity of warfarin.~      The secondary objective of this study is to compare the systemic exposure of EPA and DHA~     following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a~     mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are~     likely to be administered to patients with cardiovascular disease who are recommended to~     consume low-fat meals.~   "
124070|NCT01431677|"~     Background:~      - In individuals as they age, changes in muscle tissue can significantly affect their muscle~     strength and exercise endurance. This process, known as sarcopenia, may lead to decreased~     mobility and physical weakness, which is what we in general refer to as frailty. The causes~     of sarcopenia and why it affects some individuals more than others are not known, but many~     factors influence muscle physiology and function, including metabolic, hormonal,~     environmental, and lifestyle factors. Researchers interested in identifying factors involved~     in the start and progression of sarcopenia need of samples of human muscle tissue and cells~     for laboratory investigations.~      Objectives:~        -  To train researchers in the appropriate procedures for performing muscle biopsies and~          collecting, labeling, and storing the samples.~        -  Develop a data base of specific scientific studies evaluating the physiological and~          metabolic function of muscle that can be used in future studies.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, and will schedule a date for the muscle biopsy.~        -  Participants will have a muscle biopsy, with tissue and cells taken from the upper part~          of the thigh. A local anesthetic will be given for the procedure. Participants will~          also provide a blood sample and have an electrocardiogram to evaluate heart function.~        -  Participants will have a followup visit 1 week after the biopsy visit to evaluate the~          healing process and provide any further treatment for the affected area, after which~          they may fully resume normal activities.~   "
124071|NCT01431664|"~     RATIONALE: AT9283 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I/IIa clinical trial is studying the side effects and best dose of~     AT9283 in treating young patients with relapsed or refractory acute leukemia.~   "
124072|NCT01431651|"~     Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the~     only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the~     leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight~     loss and resolution of metabolic co-morbidities in morbidly obese patients .~      However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass~     like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine~     whether probiotics would improve annoyed GI symptoms after gastric bypass.~      Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial~     microorganisms found in the human gut. They are also called friendly bacteria or good~     bacteria. Probiotics are available to consumers mainly in the form of dietary supplements~     and foods.~   "
124073|NCT01431638|"~     This is a 36 week open-label extension of the canakinumab pre-filled syringe study for~     safety and tolerability in patients who have frequent flares of acute gouty arthritis.~   "
124074|NCT01431625|"~     AIM: To identify those mechanisms involved in the systemic and muscular response to exercise~     treatment, in two different Obstructive Chronic Pulmonary Disease (COPD) phenotypes~     (emphysema and non-emphysema). The investigators will evaluate the effect of exercise~     training, on exercise outcomes, peripheral muscle strength measures, dyspnea and quality of~     life indices, and markers of systemic inflammation and muscle repair.~      SUBJECTS: The investigators will study 30 COPD patients in GOLD II-IV stages, with~     symptomatic disease. Patients will be differentiated into 2 different phenotypes:~     predominant-emphysema and non-predominant emphysema (15 subjects for each group), according~     to high resolution computed tomography (HRCT) scanning images, and after the specific~     analysis with the MeVisPulmo software. After patients are typified, they will be included in~     the 12- wk training programme. MEASURES(pre&post-training):Basic blood analysis, EKG,~     spirometry, blood gases, pletysmography, gas diffusion, maximal inspiratory and expiratory~     pressure (MIP,MEP), bioimpedanciometry, 1RM test and isometric strength determination, 6-min~     walking test (6MWT), maximal and submaximal cycle-ergometry, and dyspnea using the Mahler's~     Basal and Transitional Dyspnoea Indexes (BDI/TDI) and quality of life (Chronic Respiratory~     Disease Questionnaire [(CRDQ]) evaluation. Besides, the investigators will measure blood PCR~     and cytokines levels (IL6, IL8, IL10, IL12, TNF-α, IGF-1, and MIC-A & MIC-B). Muscle~     biopsies will be made (quadriceps) for detection of TNF-α, TNFR-I, TNFR-II, IGF-1Ea and MGF,~     IGF-1R, genes bound to biogenesis, markers of cell lesion-stress and myosin heavy chains~     (MyHC) type I and II, N-CAM/CD56 and Met & Desmin~   "
124075|NCT01431612|"~     The aim this study was to examine to what degree the slow turnover of lactated Ringer's~     solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor~     blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery~     performed under intravenous anesthesia.~   "
124076|NCT01431599|"~     The purpose of this study is to evaluate the early clinical outcome of the short-course~     preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the~     investigators initiated the clinical trial of KROG 11-02.~   "
124077|NCT01431586|"~     This is the first study to be conducted in humans for JDTic, a new chemical entity, with~     evaluations focusing on the safety, tolerability, and pharmacokinetics (PK) of JDTic~     following administration of single oral doses. JDTic is a novel, selective κ opioid receptor~     antagonist and is currently being developed by RTI International as a potential~     pharmacotherapy to treat cocaine dependence. This study has the possibility of identifying~     the maximum tolerated dose in humans and a surrogate measure of JDTic pharmacodynamic (PD)~     activity. Data from this study will be used to plan for and define dose ranges for~     subsequent studies, as well as to identify potential indicators of JDTic pharmacological~     activity.~   "
124078|NCT01431573|"~     This pilot study seeks to replicate previous findings that sleep deprivation results in~     marked improvement in depression symptoms, as well as to test whether concurrent treatment~     with Light Therapy and Lithium are successful in locking in and maintaining therapeutic~     effects in both bipolar and unipolar depressed subjects.~   "
124079|NCT01431560|"~     The purposes of this study are to compare the outcomes of the biodegradable implants for the~     fixation of ankle fracture and those of metallic implants, and to assess the problems of the~     biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate~     and screws for ankle fracture are not different from those of metallic implants.~   "
124080|NCT01431547|"~     This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus~     for pediatric participants with advanced solid tumors. This study will have three parts.~     Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for~     dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in~     combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase~     2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the~     combination therapy.~   "
124081|NCT01431534|"~     This is a study to find a maximum tolerated dose (MTD) and pharmacokinetic (PK) data for~     ridaforolimus given to participants between the ages of 6 and 17 years with advanced solid~     tumors.~      Study-related visits concluded in August 2013. Participants may continue treatment until~     they meet discontinuation criteria or voluntarily withdraw.~   "
124082|NCT01431521|"~     This study will evaluate changes in liver fat content following multiple oral doses of~     MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.~     The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg~     twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo~     in adult male and female participants with hepatic steatosis (i.e., on order of 50%~     reduction in hepatic fat with respect to placebo is expected).~   "
124083|NCT01431508|"~     This study is being conducted to evaluate the safety and antihypertensive efficacy of~     MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to~     moderate essential hypertension.~   "
124084|NCT01431495|"~     This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in~     patients with coronary disease:~        -  Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600~          mg loading dose or after the last maintenance dose (75 mg).~        -  Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events~          (MACE).~        -  Safety Criteria: severe bleeding (GUSTO scale).~   "
124085|NCT01431482|"~     This study is an evaluation of the composition of human milk and health outcomes in~     children.~   "
124086|NCT01431469|"~     The purpose is to determine if the consumption of study product has an effect on acute~     respiratory infections and/or diarrheal disease.~   "
124087|NCT01431456|"~     Rationale:~      After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous~     thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal~     pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained~     market authorisation for prevention of venous thromboembolism after knee arthroplasty.~      However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator~     nadroparin.~      Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee~     arthroplasty. Also safety of the new oral agents with long term use of 42 days is not~     available for total knee arthroplasty.~      Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on~     safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by~     observing the incidence of major bleeding and clinical relevant non-major bleeding using a~     standardized model of bleeding definitions.~      Objective:~      The primary objective of this study is to compare the clinical safety with long term use of~     the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus~     subcutaneous administered nadroparin by observing the incidence of major bleeding and~     clinical relevant non-major bleeding in patients after knee arthroplasty surgery.~      The secondary objectives of this study are effectivity of the agents, compliance, hospital~     stay, re-hospitalisation, outpatient clinic visits and interventions following~     complications. Additionally, coagulation monitoring, knee flexion range of motion, Knee~     injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship~     between health statuses and surgery parameters will be evaluated.~      Study design:~      The study is designed as non-inferiority randomized open label controlled pilot study. A~     total of 150 patients will be included, 50 patients in each treatment group (dabigatran,~     rivaroxaban and nadroparin).~      Study population:~      Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program'~     for primary elective total knee arthroplasty and want to provide signed informed consent are~     eligible for the study.~      Intervention:~      Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee~     replacement surgery.~      Main study parameters/endpoints:~      The primary safety outcome is the incidence of bleeding events occurring during the study~     period of 135 days (including follow-up). Major bleeding events and clinically relevant~     non-major bleeding events were defined according to accepted guidelines.~   "
124088|NCT01431443|"~     The purpose of this study is to investigate the acute and chronic effect of consumption of~     flavanol-rich chocolate on endothelium function in pregnant women at high risk for~     preeclampsia.~   "
124089|NCT01431430|"~     It has been proposed that the intake of high dose of cholecalciferol may have beneficial non~     classical effects (beside bone health). This could include the reduction of type 2 diabetes~     mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These~     pleiotropic effects are mostly documented by observational and experimental studies or small~     intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as~     circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this~     population is at risk of the previously cited complications.The primary purpose of this~     study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite~     endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer~     and patient death.Renal transplant recipients between 12 and 48 months after transplantation~     will be randomized to blindly receive either high or low dose of cholecalciferol with a~     follow-up of 2 years.~   "
124090|NCT01431417|"~     A lot of shoulder function evaluation scores exist but none has been universally accepted as~     a gold standard.~      Recent studies have demonstrated the potential of computerized movement analysis with~     embedded sensors for objective evaluation of shoulder functional outcome following surgery.~      A very simple testing procedure is possible as just a few repetitions of two simple shoulder~     movements are sufficient. This could potentially facilitate implementation of shoulder~     function movement analysis in current clinical practice.~      However, at the present stage of development, the method needs to be extensively validated.~     This means that the research will intend to determine precisely for which current shoulder~     pathology it can be applied, what the outcome of healthy people is, what the reliability of~     the score is and how it can monitor patient evolution.~   "
124091|NCT01431404|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203~     liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.~   "
124092|NCT01431391|"~     The main purpose of this study is to determine whether ADT started before or after~     sipuleucel-T leads to a better immune system response. This study will also evaluate the~     safety of sipuleucel-T treatment, immune system responses over time, the characteristics of~     sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.~   "
124093|NCT01431378|"~     This study is being performed to confirm that the new technique, Model-Based Iterative~     Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for~     CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical~     Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve~     general image quality characteristics at equivalent radiation dose levels.~   "
124094|NCT01431365|"~     Smokers will complete questionnaires and smoking behaviour will be examined. After~     abstaining from smoking for approximately 18 hours, they will be randomized to a moderate~     intensity exercise group or passive sitting group. Smoking behaviour (time to first puff)~     will be assessed following treatment.~   "
124095|NCT01431352|"~     This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory~     Chinese women with PCOS will be recruited, and the randomization will be stratified by each~     participating site. Participants will be randomized into one of the two treatment arms:~     letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a~     day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual~     cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to~     5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of~     the present study is to determine the efficacy of combined treatment with letrozole and CHMG~     on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that~     the combination of letrozole and CHMG is more likely to increase the ovulation rate and~     decrease the miscarriage rate and result in a higher live birth rate in PCOS women than~     letrozole alone.~   "
124096|NCT01431339|"~     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)~     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral~     linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial~     skin or skin structure infections.~   "
124097|NCT01431326|"~     Understudied drugs will be administered to children per standard of care as prescribed by~     their treating caregiver and only biological sample collection during the time of drug~     administration will be involved. A total of approximately 3000 children aged <21 years who~     are receiving these drugs for standard of care will be enrolled and will be followed for up~     a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of~     understudied drugs for which specific dosing recommendations and safety data are lacking.~     The prescribing of drugs to children will not be part of this protocol. Taking advantage of~     procedures done as part of routine medical care (i.e. blood draws) this study will serve as~     a tool to better understand drug exposure in children receiving these drugs per standard of~     care. The data collected through this initiative will also provide valuable pharmacokinetic~     and dosing information of drugs in different pediatric age groups as well as special~     pediatric populations (i.e. obese).~   "
124098|NCT01431313|"~     This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite~     delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR)~     in subjects with pulmonary hypertension undergoing right heart catheterization.~      A total of 50 subjects with a confirmed diagnosis of pulmonary hypertension and meet all~     inclusion/exclusion criteria will be enrolled in the study which will entail a single right~     heart catheterization and nebulized nitrite dose of 45mg with one subsequent dosage of 90~     mg.~   "
124099|NCT01431300|"~     The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography~     of the central veins of the chest, and to determine whether dose reduction can be performed~     while maintaining image quality. This will be a prospective randomized study, in which~     healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram~     (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar.~     Quantitative and qualitative analysis will be performed on the images.~   "
124100|NCT01431287|"~     The overall objective of this study is to assess the efficacy and safety of 52 weeks once~     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT~     Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the~     RESPIMAT Inhaler) in patients with COPD.~   "
124101|NCT01431274|"~     The overall objective of this study is to assess the efficacy and safety of 52 weeks once~     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT~     Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the~     RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
124102|NCT01431261|"~     The purpose of this study is to test whether a physiotherapy intervention containing pain~     management, general training and specific neck exercises can improve function for patients~     with chronic neck pain.~   "
124103|NCT01431248|"~     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin~     or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result~     in stomach upset in some patients, causing them to stop taking the medication. Therefore,~     azithromycin is often prescribed instead. Azithromycin is usually taken only once and~     stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a~     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin)~     in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The~     working hypothesis is that there is no difference in the clinical effectiveness between~     antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging~     latency in PPROM.~   "
124104|NCT01431235|"~     The purpose of this study is to determine if cognitive behavioral therapy is effective in~     treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.~   "
124105|NCT01431222|"~     The primary objective in this randomized trial is to evaluate the safety and efficacy of a~     MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison~     to the previous default medical treatment - in a study population who is not amenable for~     the conventional surgical approach as current gold standard.~   "
124106|NCT01431209|"~     This phase II trial studies how well giving ruxolitinib phosphate (oral JAK inhibitor~     INCB18424) works in treating patients with relapsed or refractory diffuse large B-cell or~     peripheral T-cell non-hodgkin lymphoma and are ineligible to stem cell transplant or have~     recurrent disease after stem cell transplant. Ruxolitinib phosphate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
124107|NCT01431196|"~     Molecular expression in breast cancer (BC) defines special fenotypes with different~     prognostic and predictive features.Since the addition of trastuzumab and lapatinib to~     chemotherapy, HER2 overexpressing tumors have become the best responders to systemic~     therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative~     tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A)~     or early distant relapse after diagnosis (triple negative BC) . In this open, prospective,~     non-randomized and multicentric phase II study the investigators include stage II and III~     HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy~     Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with~     autologous dendritic cells pulsed with their own tumor. The hypothesis is that the~     reinforcement of the immune system with the autologous dendritic cell vaccination against~     HER2 negative BC could increase pathologic complete responses (pCR) and disease free~     survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance~     schedule.~   "
124108|NCT01431183|"~     The objective of this study was to assess the feasibility and effectiveness of using a~     statewide immunization information system (IIS) to send seasonal influenza vaccine reminders~     from Local Health Departments (LHDs), targeting children with high-risk conditions.~   "
124109|NCT01431170|"~     The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic~     suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The~     hypothesis of the study is that Besivance™ is as safe and effective as the current standard~     of care for the treatment of nasolacrimal duct obstruction in children.~   "
124110|NCT01431157|"~     Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and~     symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the~     level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness,~     hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias,~     pulmonary hypertension, heart failure, and premature death. There is significant evidence~     suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of~     the abnormalities associated with this disease.~      Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea.~     Mild sleep apnea is present in 17% of adults in the general population and moderate to~     severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the~     prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe~     sleep apnea to be anywhere from 11-53% in heart failure patients.~      Continuous positive airway pressure (CPAP) therapy is currently the standard of care for~     sleep apnea sufferers regardless of the severity of their disease. In patients without heart~     failure, CPAP therapy has numerous benefits and several long term studies have reported that~     CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular~     symptoms and mortality among patient with severe sleep apnea.~      In heart failure patients, CPAP has shown some beneficial short term effects but evidence of~     long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy~     reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and~     increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival~     or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is~     often poor and many people cannot tolerate it. This further limits the therapeutic~     effectiveness of this intervention.~      The purpose of this study is to assess whether nocturnal oxygen administration via nasal~     cannula alone can improve outcomes in congestive heart failure patients with moderate to~     severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using~     biomarkers of heart stress and markers of whole body inflammation.~   "
124111|NCT01431144|"~     This study is a comparison of implant placed and simultaneously grafted with either~     autogenous connective tissue or a connective tissue allograft. The objective is to determine~     the change in soft tissue thickness and determine if a better result is obtained with the~     autograft or the allograft. The hypothesis is that there will be no difference in soft~     tissue thickness over the implant between the autograft and the allograft technique.~   "
124112|NCT01431131|"~     The purpose of this study is to compare two methods of ridge preservation in the maxillary~     anterior esthetic zone to determine the best method to establish adequate bone and soft~     tissue to accommodate implant placement. For the positive control group a mineralized~     cancellous allograft will be placed in the extraction socket. For the test group a~     mineralized cancellous allograft will be placed in the extraction socket plus an additional~     graft will be placed to overlay the facial surface of the socket that will be composed of~     bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional~     change and histologic analysis of the graft material at 4 months post-placement.~   "
124113|NCT01431118|"~     The purpose of the study is:~        -  To investigate the effect of sport-specific stress in the iron metabolism of dragon~          boat athletes~        -  To investigate the effects of sport-specific stress in the activity of pro-hepcidin and~          hepcidin~   "
124114|NCT01431105|"~     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the~     developed world. Despite available treatment, 25% of children in San Diego County~     appropriately treated for KD develop coronary artery abnormalities that could lead to~     complications later in life, including heart attack. Although investigators can identify~     children with KD that have these coronary artery abnormalities, there is no approved~     additional treatment to decrease coronary artery inflammation and arrest or prevent damage~     to the coronary arteries. Inflammation and damage to the arterial wall is central to these~     coronary artery abnormalities. Statins, a class of drugs that is known for lowering~     cholesterol, have also been shown to decrease inflammation in general as well as at the~     level of the vessel wall. Therefore, the investigators propose to study the safety of the~     drug atorvastatin in children with coronary artery abnormalities from KD.~   "
124115|NCT01431092|"~     In this trial, researchers aim to investigate if prolonged-release melatonin can facilitate~     the withdrawal of chronic benzodiazepine administration in patients with schizophrenia.~     Furthermore, researchers will investigate the association of benzodiazepine dose reduction~     with the following clinically important variables: sleep, psychophysiology, cognition,~     social function, and quality of life.~   "
124116|NCT01431079|"~     The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV)~     vaccine acceptability among college men based on the Health Belief Model through focus~     groups, (2) triangulate focus group results with a prior quantitative study in developing an~     intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3)~     test the efficacy of the above intervention based on the Health Belief Model by comparing it~     to a knowledge-based intervention. Approximately five focus groups with ten participants in~     each group with college students in the ages 18-25 years will be conducted at a large~     Midwestern University for the qualitative piece. Data will be analyzed for categories and~     triangulated with previous study to develop a theory based intervention. For the~     quantitative piece a randomized controlled design with 45 participants in each arm (theory~     based intervention and knowledge based intervention) will be implemented.~   "
124117|NCT01431066|"~     Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals~     in the workplace who must stand for prolonged periods of time, and athletes. It can be~     disabling. There is no single accepted treatment course that is recommended in the~     literature.~      The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a~     treatment option in chronic soft-tissue injury due to its ability to reduce pain and~     inflammation.~      The proposed study will investigate the efficacy of the use of a PRFE device for the~     treatment of chronic heel pain using a double blind randomized placebo controlled design~     study.~   "
124118|NCT01431053|"~     This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as~     the adjuvant treatment in postmenopausal breast cancer patients.~   "
124119|NCT01431040|"~     Preoperative bowel preparation for surgical management of pelvic floor disorders is~     performed inconsistently, and includes no prep, the use of dietary changes or bowel altering~     interventions. Retrospective studies of emergency colonic surgery first demonstrated a low~     rate of infectious complications without a bowel prep. Recently, data supporting the routine~     use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical~     outcomes are similar between patients that undergo a bowel preparation versus those that do~     not, indicating that the long held dogma of mechanical bowel preparation should be used~     selectively. Despite routine use, there is a paucity of literature addressing the approach~     to, and/or need for preoperative bowel management at the time of vaginal reconstructive or~     obliterative surgery. The majority of the pelvic floor disorder population is older, tending~     to have more bowel dysfunction (especially symptoms of constipation) than younger women.~      The aim of this study is to evaluate preoperative bowel management strategy as it relates to~     the total care of the vaginal surgery patients' intra-and post-operative bowel function and~     overall patient experience. Two commonly used pre-operative bowel prep strategies: no~     preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value~     of bowel preparation or diet change in vaginal surgery, both from the physician's and~     patient's point of view. In this pilot study, subjects are randomized to either a clear~     liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after~     midnight, or NPO after midnight without any dietary changes or enemas.~      Our aims are:~      *Primary - To assess the surgeons' objective intraoperative evaluation of the effects of~     bowel preparation (adequate visualization, stooling during case, difficulty with bowel~     handling) *Secondary - (1)To characterize the patients' experience and acceptance of~     preoperative bowel management regimen versus no preoperative bowel preparation(2) To~     characterize the patients' postoperative experience and determine if the preoperative bowel~     regimen affects time to first bowel movement/first normal stool as well as stool experience~     as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups~     (4)Characterize other descriptive qualities of the patients' operative experience(duration~     of case, length of hospital stay)~   "
124120|NCT01431027|"~     Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and~     includes abnormal LV diastolic distensibility, impaired filling and slow or delayed~     relaxation- regardless of whether the ejection fraction is normal or depressed and whether~     the patient is asymptomatic or symptomatic. Epidemiologic studies have demonstrated high~     prevalence of diastolic heart failure (DHF). The quality of life of these patients is~     impaired and the clinical outcomes are similar to those with heart failure with systolic~     dysfunction. Therefore diastolic dysfunction has significant adverse economic impact that is~     expected to grow further with time. Clinical characteristics alone may not be sufficient to~     diagnose diastolic dysfunction. A number of invasive and non-invasive parameters have been~     proposed to diagnose diastolic dysfunction. Most of the presently used non-invasive~     parameters have a number of limitations. High fidelity measurement of the left ventricular~     pressures is needed to accurately diagnose diastolic dysfunction. Obtaining it in routine~     clinical practice is impractical.~      In this protocol the investigators have proposed a novel non-invasive parameter called~     'Torsional Hysteresis' as a measure of diastolic function. This will be measured using~     non-invasive cardiac MRI technique. During left ventricular contraction and relaxation,~     myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to~     beginning of each contraction. However the rate with which it returns to the baseline state~     is variable. Torsion indicates relative wringing motion of the ventricle around a left~     ventricular axis and is a global parameter of left ventricular deformation. The parameters~     have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI~     assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional~     hysteresis area is increased as compared to no diastolic dysfunction group.~   "
124121|NCT01431014|"~     Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons~     after orthognathic surgery. The purpose of this study is to develop a steroid regimen~     protocol for minimizing postoperative facial swelling after orthognathic surgery.~   "
124122|NCT01431001|"~     The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive~     transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.~   "
124123|NCT01430988|"~     The purpose of the current study is proposed to prospectively assess how accurately the~     BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.~   "
124124|NCT01430975|"~     This study is to be performed at two clinical sites where patients received CardioGen-82~     during the time period January to June, 2011 and where patients were scanned chronologically~     near to the index patients (2 days before or after). Of these, it is planned that at least~     30 patients will be entered in this trial. Index patient is the term applied to individuals~     who had radiation spectra indicative of Sr-82 and Sr-85 detected by hand-held survey meters.~   "
124125|NCT01430962|"~     The purpose of the study is to determine if there are any differences in yield or safety of~     Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of~     bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.~   "
124126|NCT01430949|"~     The Genesis Feasibility Study will collect clinical information on the use of the Bard~     Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping,~     cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV)~     ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. Patients will be~     followed up for 12 months to assess the primary safety endpoint of Major Complications (a~     composite safety endpoint)and effectiveness, defined as Long-Term Success (freedom from~     recurrent atrial arrhythmia.~   "
124127|NCT01430936|"~     This is planned as a feasibility study. The objective is to evaluate a specially designed~     patient adherence and monitoring software on standard mobile devices in remote monitoring of~     heart failure patients.~   "
124128|NCT01430923|"~     The purpose of this study is to:~        -  To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost~          stored at refrigeration temperature with respect to the diurnal intraocular pressure~          (IOP) change from baseline after 3 months of therapy in patients with open-angle~          glaucoma (OAG) or ocular hypertension.~        -  To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients~          with open-angle glaucoma (OAG) or ocular hypertension.~   "
124129|NCT01430910|"~     This is a randomised study divided into 2 parts. Part A investigates the effect of prolonged~     dosing (ten days) with Avibactam and Ceftazidime when given together and how this will~     effect how much Avibactam and Ceftazidime enters the blood. Part B investigates how much~     Avibactam (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given~     separately or together intravenously.~   "
124545|NCT01425437|"~     Much progress in treatment of various tumors has been made in the laboratory and the results~     have been brought back to the patients, i.e. from bench to bedside. This trial intends to~     collect samples of keloid tissue from patients and study them in laboratory. Such a research~     may help us with finding better treatments for keloid.~   "
124130|NCT01430897|"~     Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in~     d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the~     assessment of the right ventricle (RV).~      In this study the investigators sought to evaluate systemic RV myocardial mass and function~     after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function~     under special consideration of the interventricular septal (IVS) movement.~   "
124131|NCT01430884|"~     During elective percutaneous coronary intervention (PCI), both proximal and distal~     protection devices are used. The distal occlusion protection device temporarily occludes the~     vessel distal to the lesion during the intervention, thereby capturing both particular~     debris and soluble substances released from the lesion such that they can be aspirated and~     prevented from reaching the coronary microcirculation. Rather than simply discarding the~     material which is retrieved from use of protection devices, the investigators have recently~     taken advantage of this situation, sampled the particulate and soluble material and~     subjected it to a variety of analyses with the ultimate goal to have a better insight into~     the respective plaque composition and to correlate it to the individual imaging and clinical~     data. On the basis of such information the investigators aim to better understand the~     pathophysiology of plaque vulnerability and to possibly predict the clinical development of~     the individual patient.~   "
124132|NCT01430871|"~     Serotonin has recently been identified as a major regulator of bone formation. Gut-derived~     serotonin inhibits bone formation, and early animal studies have shown that inhibition of~     gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway~     has potential to be developed as a new anabolic treatment for osteoporosis in humans.~      Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be~     expected that patients with carcinoid disease would have reduced bone formation, low bone~     mass and fractures. However, this has not been apparent in clinical practice. There may be a~     discrepancy between rodent models and human disease. This study aims to identify whether~     patients with carcinoid disease have reduced bone mass, reduced bone formation or high~     fracture rates. The investigators will conduct a cross-sectional observational case-control~     study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and~     gender-, age- and body mass index (BMI)-matched controls.~   "
124133|NCT01430858|"~     The overall aim of this study is to test the hypothesis that vibration exercise can induce~     higher than normal bone strains and strain rates than are experienced during habitual~     locomotor activities.~      The investigators plan to study healthy young volunteers to:~        1. Determine the relationship between tibial bone strain and~             -  the frequency and amplitude of vibration therapy~             -  a range of habitual locomotor activities;~        2. Determine the transmission of vibrations during vibration therapy, in terms of~             -  amplitude attenuation and phase shift of positional coordinates and accelerations~               at anatomic landmarks along the lower leg and other skeletal sites~             -  the relationship between these and different frequencies and amplitudes of~               vibration therapy;~        3. Determine the muscle power in the lower limb associated with various habitual locomotor~          activities and its relationship to the measured tibial bone strain.~      The investigators subsequently hope to use the data captured in this experiment to develop a~     QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The~     investigators will then validate this model in relation to the characteristics (amplitude~     and phase shift) of the measured tibial bone strain and transmission of vibrations to the~     different anatomical landmarks during vibration therapy.~   "
124134|NCT01430845|"~     The purpose of this study is to find the relationship between the stage and quality of~     developmental delay during infancy and toddler age, and the final diagnosis that the child~     gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).~   "
124135|NCT01430832|"~     The purpose of this study is to assess the emotional well being of mothers to preterm~     infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress~     levels will be taken into consideration. In addition, the correlation between the infant's~     development and the mother's emotional state will be analyzed.~   "
124136|NCT01430819|"~     The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012~     formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and~     older.~      Objectives:~        -  To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥~          65 years of age.~        -  To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among~          adults ≥ 65 years of age.~   "
124137|NCT01430806|"~     Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other~     antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion~     channel properties similar to amiodarone.~      Several case reports have shown promising results with Dronedarone for this patient~     population.~   "
124138|NCT01430793|"~     The purpose of the study is determination of effective vitamin D replacement strategy in~     vitamin D deficiency states with currently available preparations in Pakistan & to determine~     the cost effective monitoring strategy with urinary calcium excretion serving as a surrogate~     marker of achievement of vitamin D sufficiency state.~      The study will be conducted at the out-patient Endocrinology Clinics of the Aga Khan~     University Hospital, Karachi, Pakistan. All patients seen in endocrine clinics with Vitamin~     D level less than 20 ng and do not have any of exclusion criteria mentioned below will be~     eligible for recruitment in the study. The study participants will be randomly assigned into~     4 groups for intervention to receive intramuscular or oral Vitamin D in 200,000 or 600,000~     units as per group allocation. Each group will comprise of 25 participants.~      Group 1: Vitamin D3 600,000 units IM and then every 2 monthly for 2 times if levels remain <~     30 ng/ml.~      Group 2: Vitamin D3 600,000 units orally and then every 2 monthly for 2 times if levels~     remain < 30 ng/ml.~      Group 3: Vitamin D3 200,000 units IM initially and then every 2 monthly for 2 months if~     levels remain < 30 ng/ml.~      Group 4: Vitamin D3 200,000 units orally initially and then every 2 monthly for 2 times if~     levels remain < 30 ng/ml.~      All patients will be prescribed elemental Calcium 1 gram /day. Vitamin D levels along with~     the other biochemical parameter and random urine for calcium & creatinine will be checked at~     00, 02, 04, 06 and 12 months.~   "
124985|NCT01419691|"~     The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat~     patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or~     prolymphocytic lymphoma (PLL).~   "
124139|NCT01430780|"~     Basic studies has showed that sustained use of nitrates might associated with adverse~     effects on vascular function mediated by an increase in nitrate-induced oxidative stress.~     But it remains unclear whether oxidative stress increases with endothelial function~     impairment in patients with coronary artery disease (CAD) during administration of long-term~     oral nitrates. The investigators evaluated whether administration of long-term isosorbide~     mononitrate (ISMN) treatment was associated with oxidative stress increase and endothelial~     function impairment in patients with CAD.~   "
124140|NCT01430767|"~     Poor adherence is a common reason for treatment failure in many fields of medicine, and~     likely affects common psychiatric treatments as well. Members of the present study team have~     used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor~     adherence in skin disease, and have shown that they provide a much more accurate measure of~     adherence behavior than self-reports, pill counts, or serum drug concentrations. The present~     study will use MEMS® caps to measure adherence in 10 patients with depression and 10~     patients with attention-deficit hyperactivity disorder (ADHD) from a student clinic~     population. The aims will be to show the usefulness of MEMS® caps in measuring adherence to~     psychiatric treatment, and gather data on typical adherence rates for depression and ADHD~     patients on typical treatment regimens. The data obtained will be used to inform future~     studies that use an intervention to improve adherence behavior and ultimately disease~     outcomes.~   "
124141|NCT01430754|"~     The purpose of this study is to evaluate the maintenance effect and safety of 20 mg~     tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.~   "
124142|NCT01430741|"~     A major goal for the Department of Veterans Affairs is to end Veteran homelessness by 2015.~     The VA's largest homelessness initiative is the joint Departments of Housing and Urban~     Development (HUD) and Veterans Affairs (VA) Supportive Housing program (HUD-VASH), which has~     been expanded greatly over recent years via the allocation of 30,000 Housing First vouchers~     between 2008 and 2010 and increased funding to hire 1,000 new program case managers.~     However, recent expansion has resulted in a number of implementation challenges including~     delays in the distribution of housing vouchers and dropout among program participants (25%~     of those housed in HUD-VASH drop out within a year). Much of this dropout can be attributed~     to untreated issues facing many Veterans enrolled in HUD-VASH. The most common among these~     untreated issues are mental health and substance use disorders. The presence of these~     disorders is due in large part to the fact that much of HUD-VASH case management focuses on~     housing placement and maintenance, with limited attention to mental health, substance abuse,~     and other related psychosocial issues, which when left untreated, negatively impacts voucher~     distribution and housing stability. This project will test an implementation model-Getting~     To Outcomes (GTO)-designed to assist in the delivery of an intervention for Veterans with~     co-occurring mental health and substance use disorders (MISSION-Vet) in the HUD-VASH~     program. The proposed study will compare implementation of MISSION-Vet currently being~     planned through VA Office of Patient Care Services to an enhanced approach using the GTO~     model. Thus, this project can contribute to ending all Veteran homelessness by 2015, a~     pledge made by President Obama.~   "
124143|NCT01430728|"~     The purpose of this study is to examine the range of cerebral tissue oxygen saturation in~     healthy and sick very low birthweight infants during the first 72 hours of life.~   "
124144|NCT01430715|"~     The increasing use of sedentary screen-based activities (SBAs) has been most recently blamed~     for children and adolescents' lack of engagement in physical activity (PA). Studies indicate~     a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs~     appear to compete for time to engage in PA. If sedentary behavior is a substitute for PA, to~     help increase PA, strategies need to be put into place that helps to decrease sedentary~     behaviors.~      One modification to sedentary videogames that may increase PA in children is to alter~     sedentary videogames so that the videogames actually provide an option to engage in PA,~     rather than to be sedentary. These types of games then don't compete with PA, but actually~     are a source of PA. These types of videogames are called active video games (AVG) or~     Exer-gaming. Previous research demonstrates that energy-expenditure (EE) in AVG play is~     comparable to moderate-intensity walking and produce greater EE than sedentary SBAs.~     However, previous studies have been limited to measuring EE in AVG play to walking either on~     a treadmill or in a structured setting. Studies have not investigated the EE of AVG play~     compared to the EE in free-living outdoor play. Thus, the purpose of the proposed study is~     to determine whether a greater EE is released during AVG play compared to free-living,~     outdoor play in children.~   "
124145|NCT01430702|"~     Care transition interventions have been successful in reducing medication-related problems~     and associated rehospitalization primarily by focusing on medication reconciliation~     conducted by trained healthcare professionals. Programs to improve the medication~     reconciliation process have largely been effective, but have limitations including the~     expense associated with recruiting, training, and retaining care transition healthcare~     professionals (e.g., nurses and nurse practitioners) the ability to provide services within~     a finite geographic area, and the retrospective nature of the reconciliation process which~     usually occurs in the home following hospital discharge. Our short-term objective is to use~     Pennsylvania Department of Aging resources to assess the feasibility of using a telemedicine~     medication delivery unit for frail older adults that require medication assistance in their~     home immediately following an acute hospitalization. As part of this feasibility assessment,~     the investigators will assess (1) recruitment process and procedures, (2) data collection~     procedures, (3) resource utilization, (4) drop-out rates, (5) acceptability and usability of~     the EMMA® telemedicine medication delivery unit, (6) medication adherence, and (7)~     medication-reconciliation errors during transition from hospital to home.~   "
124185|NCT01430182|"~     The purpose of this study is to determine whether, for surgery of the tibia, one dose of~     methadone provides better control of pain afterward as compared to morphine, which is the~     usual drug given to control pain after surgery. Immediately after the beginning of general~     anesthesia (intraoperatively), subjects will receive one dose of either methadone or~     morphine, in the amount of 0.2 milligrams per kilogram of body weight, intravenously.~      The primary hypothesis is that, subjects who receive one dose of methadone intraoperatively~     will require less pain medicine than subjects who receive one dose of morphine~     intraoperatively.~   "
124146|NCT01430689|"~     The Center for Vaccine Development - Mali is interested in learning if vaccinating a~     pregnant woman against influenza will protect her infant against this disease. The~     investigators know that influenza infection, the flu, affects pregnant women and their~     infants in Mali. The illness known as flu is caused by a germ (virus) that is passed easily~     among people. The flu causes symptoms such as fever, cough, sore throat, runny nose, and~     body aches. Certain groups of people, such as pregnant women and infants, are at risk for~     having severe disease when they get the flu. Vaccination against influenza is not routinely~     available to pregnant women in Mali although it is recommended.~      Women who wish to participate will have 5 visits to the clinic and weekly visits to the home~     to follow the health of the woman and her infant when it is born. The investigators will~     also ask permission to make weekly visits to all children under 5 years of age to follow~     their health as it relates to influenza infection.~      A substudy was added in December 2014 to test a subset of the nasal/oropharyngeal samples~     collected from the pregnant women and infants for RSV and pertussis to describe the~     epidemiologyof infections in this population. Additional testing on stored serum samples~     from these individuals in an attempt to identify a protective titer of antibody that could~     protect infants from these infections.~   "
124147|NCT01430676|"~     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.~     The aim of present study is to use large-scale data from DVHD to uncover risk factors for~     readmission, reoperation (any indication), death and reoperation for recurrence after~     incisional hernia repair.~   "
124148|NCT01430663|"~     Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with~     hematological malignancies. The clinical significance of testing bronchoalveolar lavage~     (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM)~     ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a~     validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from~     hematological patients at high risk of PA.~   "
124149|NCT01430650|"~     The aim of this trial is compare two different endometrial priming protocols~        -  women that receive oral estrogens~        -  women that receive transdermal estrogens~   "
124150|NCT01430637|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying genes in samples from younger patients with~     desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.~   "
124151|NCT01430624|"~     The purpose of this study is to evaluate whether a brief intervention in video format, that~     includes education about reactions to assault and modeling of adaptive coping strategies,~     designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of~     sexual assault at the time of receipt of post assault medical care is associated with better~     post-assault outcomes as compared to a comparable length video that includes pleasant~     imagery and relaxation instruction or standard care.~   "
124152|NCT01430611|"~     This study is part of the post-licensure commitment to evaluate the safety and~     immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.~      Primary Objective:~      To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C,~     30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide~     Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C)~     Polysaccharide Vaccine.~      Secondary Objective:~        -  To describe the immunogenicity for serogroups A and C, 30 days after administration of~          the study vaccines given as a single dose.~        -  To describe the full reactogenicity profile after administration of the study vaccines~          given as a single dose.~   "
124153|NCT01430598|"~     The investigators aim to establish whether completing a subacromial decompression before or~     after repair of a complete rotator cuff tear has any clinical significance. Both the~     arthroscopic decompression and rotator cuff repair will be completed during the same~     surgical date. The investigators null hypothesis contends that full-thickness rotator cuff~     tear repair performed before versus after subacromial decompression will not influence~     patient's post-operative pain or functionality.~   "
124154|NCT01430585|"~     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis~     that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or~     acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high~     Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker~     of cellular proliferation, could be used to select those patients who benefit from treatment~     with a PI3K-pathway inhibitor.~   "
124155|NCT01430572|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients~     with advanced cancer. The safety of these drugs will also be studied.~      Pazopanib is designed to block different receptors in the cancer cells that ultimately are~     responsible for the growth of the tumor and its blood vessels.~      Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also~     involved in cancer growth.~   "
124156|NCT01430559|"~     This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index~     (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will~     also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis~     in this population.~   "
124157|NCT01430546|"~     The purpose of this study is to quantify the burden of treatment in relapsed or refractory~     multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.~   "
124158|NCT01430533|"~     The purpose of this study is to determine the dermal sensitization potential of azelaic acid~     pre-foam formulation.~   "
124159|NCT01430520|"~     Pain is a major problem after TKA, especially in patients with high pain catastrophizing.~     Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and~     emotional effect. The investigators therefore investigate the effect of Escitalopram as a~     perioperative analgesic.~   "
124242|NCT01429428|"~     This is a randomized and controlled study to investigate if the far-IR radiation emitted by~     compression stockings fabric may be effective and safe as adjuvant treatment for cellulitis~     that affects the majority of women after puberty.~      The investigators expect that the far-IR effects on superficial microcirculation,deep dermis~     and subcutaneous fat may attenuate the clinical aspect of cellulitis.~   "
124160|NCT01430507|"~     Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that~     causes progressive damage to joints of the body, affecting the functional capacity.~     Effective management of patients with RA requires a multidisciplinary approach. Despite the~     various combinations, there is a significant population of RA patients who are not~     responding to these combinations or showing inadequate response to methotrexate alone.~     Hence, there is a need for a unique combination of drugs targeting different pathological~     process to yield the best results in those patients where prognosis is poor. Combination of~     revamilast with first line therapy like methotrexate could provide better treatment options~     to a larger population of RA patients having moderate to severe disease and who are~     inadequately controlled on one or the other DMARDs.~      This is randomized, double-blind, placebo-controlled, parallel group study. The study will~     include patients with active RA receiving stable and maximum tolerated dose of MTX.~      Patients will be recruited after providing written informed consent. After screening and run~     in period (single blind placebo for 4 weeks), patients will be randomized (meeting~     randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium~     and High) of revamilast or placebo along with MTX.~      The primary objective of the study is to determine the percentage of patients achieving~     ACR20 response at 12 weeks. Secondary objectives include determining percentage of patients~     with ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values~     and frequency and use of rescue medication.~      During the treatment period, there will be 5 further study visits at week 2, week 4, week 8,~     week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be~     follow up visit.~   "
124161|NCT01430494|"~     To collect characteristics of patients with ADPKD across a broad population, over time to~     better understand disease progression (signs, symptoms and outcomes). Association with total~     kidney volume changes and other measures of disease progression will be determined in order~     to identify a population at increased risk for disease progression. The economic and quality~     life impact of ADPKD will be assessed. Subjects who terminated participation early from~     clinical trials with tolvaptan may also be followed.~   "
124162|NCT01430481|"~     The aim of this study is to compare three combinations of preparations in a comparative~     trial program on rosehip powder for knee OA. The trial is a comparative, 12-week,~     randomized, double-blind, active-controlled trial, designed to determine the comparative~     efficacy and safety of these preparations in patients with pain from knee OA.~   "
124163|NCT01430468|"~     This is a non blinded prospective randomized clinical trial to define the efficacy of a new~     technology developed at the Cleveland Clinic to improve the positioning of the glenoid~     component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on~     the development and validation of this new technology for the last six years. The~     investigators have validated the pre-operative planning software and published the results~     in the peer review literature (1, 7, 8, 9). The investigators have used this software in the~     planning of total shoulder surgery over the last three years. The investigators have~     validated the accuracy and reproducibility of the patient-specific instrumentation in both~     cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies~     also validated our ability to precisely measure component position using 3D CT scan imaging~     after placement of the implants in a pre-clinical cadaver study, thereby validating our~     ability to accurately measure and compare component position between the groups described in~     this proposed clinical trial. The investigators have also proven the ability of the software~     and techniques to produce an accurate representation of the glenoid morphology in patients~     with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB~     approved patient safety study performed at the Cleveland Clinic. The investigators have~     performed extensive studies of the materials and processes for the fabrication,~     sterilization and packaging of the patient specific instruments. The investigators have~     selected materials and processes that have met all of the FDA requirements for use of these~     materials and processes as clinical devices in vivo. These devices (non implanted~     instruments) are generally classified by FDA as a Class I device not having significant~     clinical risk. The investigators have studied the materials and process to produce accurate~     instruments that meet the clinical specification for fit onto the surrogate glenoid surfaces~     and maintain this shape and fit after sterilization. These same patient specific instruments~     have been tested in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability~     to perform the functions specified with a high level of accuracy and much better than the~     use of standard generic instruments.~   "
124164|NCT01430455|"~     This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective~     treatment of bipolar depression. New treatments are needed, as there is little evidence that~     standard antidepressants are effective in treating this condition, and the two antipsychotic~     medications that have indications for bipolar depression can cause substantial side effects.~     This study will focus specifically on currently depressed outpatients having a bipolar~     history for whom at least one standard antidepressant medication was ineffective. Patients~     will be treated openly with tranylcypromine for 8-10 months, depending on treatment~     response.~   "
124165|NCT01430442|"~     The purpose of this study is the exploration of a wide range of BMS-927711 doses that will~     reveal at least one dose that is safe and clinically superior to placebo in the treatment of~     acute migraine.~   "
124166|NCT01430429|"~     The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in~     primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.~   "
124167|NCT01430416|"~     This study has two parts, dose escalation and dose expansion. For dose escalation, the~     primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with~     uveal melanoma. For dose expansion, the primary objective is to characterize the safety and~     tolerability of the MTD of AEB071 in patients with uveal melanoma.~   "
124168|NCT01430403|"~     The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments ―~     omalizumab, corticosteroid therapy boost, and placebo ― in reducing fall exacerbations in~     inner-city children and adolescents with allergic persistent asthma when initiated~     approximately 4 -6 weeks prior to the start of the first day of each participant's school~     year.~   "
124169|NCT01430390|"~     The purpose of this study is to test the safety of giving the patient special cells from a~     donor called Modified T-cells. The goal is to find a safe dose of modified T-cells for~     patients with relapsed B cell leukemia or lymphoma after a blood SCT. The investigators also~     want to find out what effects these T-cells have on the patient and the disease.~   "
124170|NCT01430377|"~     The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous~     coronary intervention (PCI) is still not established. The predilatation could potentially~     damage SB ostium by vessel dissection, making subsequent wiring problematic. However,~     predilatation could eliminate SB ostial stenosis obviating need for further SB treatment~     after main vessel stent implantation. The aim of the study is to assess in random fashion~     the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with~     and without SB predilatation.~   "
124171|NCT01430364|"~     Study aims: to compare two intervention strategies for bifurcation treatment - provisional~     T-stenting (PTS) with drug-eluting stent (sirolimus eluting), with kissing balloon inflation~     at the end of procedure - the best treatment strategy at the moment, with stenting of~     bifurcation lesions with dedicated bifurcation drug-eluting stent BiOSS Lym.~   "
124351|NCT01427998|"~     Background: Animal studies indicate that olive leaf extract normalizes blood glucose. We~     hypothesized that olive leaf extract might be of benefit in human subjects.~      Methods: A total of 79 adults with diabetes were randomly assigned to treatment with olive~     leaf extract capsules or matched placebo. Measures of glucose homeostasis including glucose,~     insulin and HbA1c were measured and compared by treatment group.~   "
124172|NCT01430351|"~     The goal of this clinical research study is to find the highest tolerable dose of~     temozolomide in combination with memantine, mefloquine, and/or metformin that can be given~     to patients with glioblastoma who have already been given radiation and chemotherapy in~     combination. The safety of these drug combinations will also be studied.~      Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of~     cells). The damaged DNA may cause tumor cell death.~      Memantine is designed to block the activity of a protein found on the surface of cells that~     may control tumor growth and survival. This may stop further spread of tumor cells.~      Mefloquine is designed to block a protein that helps to clean the waste in the cells and to~     destabilize the cell membrane. Blocking this protein may cause tumor cell death.~      Metformin is designed to block a protein in tumor cells that is important in tumor growth~     and blood vessel development. This may cause cell death or reduce the spread of the disease.~   "
124173|NCT01430338|"~     Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and~     especially during acute cold exposure. It is conceivable that BAT activity might reduce the~     risk of developing obesity since fat stores are used for thermogenesis, and a directed~     enhancement of adipocyte metabolism might have value in weight reduction. So it is important~     to know the different metabolic characteristics in human adults who have detected BAT.~     Therefore, the purpose of the investigators study is to compare different metabolic~     characteristics in the presence of brown adipose tissue in humans.~   "
124174|NCT01430325|"~     SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion~     and will be asked to what chamber pressure they were compressed and what gas they breathed.~   "
124175|NCT01430312|"~     The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam~     formulation.~   "
124176|NCT01430299|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a~     retrospective comparison to a historical patient cohort.~   "
124177|NCT01430286|"~     The aim of the project is to evaluate the efficacy of a web-based psycho-educational~     programme designed to support informal caregivers of patients with Alzheimer's disease~     (AD).This program focuses on information about the illness, her progression, how to prevent~     psychological strain using anticipation and relaxation techniques and providing a virtual~     space (forum) to discuss with other caregivers.~   "
124178|NCT01430273|"~     Main Objective: The purpose of this study is to demonstrate whether there is a correlation~     between perioperative blood loss and the degree of platelet inhibition assessed by a point~     of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet~     mono/bi-therapy~   "
124179|NCT01430260|"~     This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in~     combination.~   "
124180|NCT01430247|"~     INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes,~     without any obvious structural or pathological anomalies. Amblyopic eye should be able to~     regain some VA if treatment is initiated before the age of seven. It is the leading cause of~     monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly~     monocular, hence children are general asymptomatic. VA testing is the only reliable method~     of detecting amblyopia, and the fourth year of life is considered best for vision screening~     programs.~      AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the~     study is to evidence the problem of amblyopia in Zagreb and to release a model for formal,~     government directed vision-screening program as a Croatian public health policy.~      HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic~     factors, along with treatment efficacy is impossible to quantify, since no population-based~     studies have been performed regarding this issue. In addition, national screening of~     preschool children does not exist, while the school-entry screening is prescribed by law.~     The object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old~     children of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on~     reducing amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity~     monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in~     detecting amblyopia.~      PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both~     parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the~     kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological~     examination is VA <0.8.~   "
124181|NCT01430234|"~     Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement~     according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is~     mandatory for the treatment to be effective. In addition, consultation of a specialized~     dietician is pivotal to educate patients about the proper use of pancreatic enzymes.~     However, based on a recent prospective survey in the Netherlands amongst chronic~     pancreatitis patients, it seems that enzymes are underused and a dietician is seldom~     consulted. The aim of this study is to assess if there is a difference in efficacy of~     pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison~     to the standard treatment for patients with EPI.~   "
124182|NCT01430221|"~     The purpose of this study is to compare the effectiveness of educational and lifestyle~     intervention programs aimed at reducing fasting blood sugar and emotional distress in adults~     with prediabetes.~   "
124183|NCT01430208|"~     Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine~     diseases. The development of smaller hysteroscopes allowed to change the approach to the~     intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al.~     developed a mini-resectoscope feasible for see&treat hysteroscopy. The objective of the~     study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr~     resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions.~     The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas,~     randomly allocated to receive the treatment with traditional resectoscope (127 women), with~     mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating~     time, distension media delivered, dismiss time and discomfort experienced were recorded.~   "
124184|NCT01430195|"~     The purpose of this study is to look at the efficacy of afamelanotide, when combined with~     narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.~     Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to~     reducing frequency and doses of NB-UVB.~   "
124317|NCT01428440|"~     Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live~     longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get~     rid of cancers. A biomarker that would allow apoptosis in tumours to be imaged directly~     would provide a powerful new tool for oncology drug development and potentially contribute~     to improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging~     tumour apoptosis in patients receiving standard chemotherapy treatment for their cancer.~   "
124186|NCT01430169|"~     This study is a Phase 2, open-label study to assess the pharmacokinetics (PK) and safety of~     AA4500 0.58 mg in men with Peyronie's disease. Subjects will be screened for study~     eligibility within 21 days before the initial injection of study drug. Two injections will~     be administered 24 hours apart.~      Subjects will be admitted to the study unit the day before the first injection of AA4500~     (Day -1) and will remain in the study unit until after the PK sample is collected after~     investigator penile plaque modeling on Day 3. Subjects will return to the study unit on Day~     4, Day 8, and Day 29 for follow-up pharmacokinetic and safety assessments.Pharmacokinetic~     plasma samples will be collected at predetermined time points before (15 minutes~     pre-injection) and after each injection on Day 1 and Day 2 (5,10, 20, 30 minutes and~     1,2,3,4,8,12 hours after), and on Days 3, 4, 8, and 29.Plasma levels for AUX-I (clostridial~     type I collagenase) and AUX-II (clostridial type II collagenase) will be determined.~   "
124187|NCT01430156|"~     This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of~     Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can~     upregulate HO-1, which has been shown to have a protective effect on animal transplants.~      The investigators will be giving HA/placebo to participants prior to transplant and repeat~     again on day 2 post-transplant and compare outcomes.~   "
124188|NCT01430143|"~     The aim of the study is to 1) delineate the molecular mechanisms behind the large variation~     in insulin sensitivity among apparently healthy subjects and to 2) establish the~     dose-response relationship between physical training and a) metabolic health, b) appetite~     and c) cultural health.~   "
124189|NCT01430130|"~     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne~     is conducting this research to study whether the investigational dressing, called the~     Neodyne Dressing, can minimize scar formation in a simple manner.~   "
124190|NCT01430117|"~     The objective of this study is to determine the biologic activity of a Poa pratensis~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
124191|NCT01430104|"~     The purpose of this trial is to assess the effects on serum calcium when teriparatide is~     used with active vitamin D in osteoporosis patients.~      This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment~     Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium~     supplementation from the Lead-in Period throughout the study. During the Treatment Period,~     daily administration of teriparatide will be added.~   "
124192|NCT01430091|"~     This study compares the clinical tablet formulation of prasugrel taken orally with an orally~     disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel~     active metabolite circulating in the blood for each treatment.~   "
124193|NCT01430078|"~     The objective of the study is to assess the bioavailability of ASP015K within the~     gastrointestinal tract.~   "
124194|NCT01430065|"~     This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy~     volunteers.~   "
124195|NCT01430052|"~     The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1~     combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for~     unresectable locally advanced pancreatic cancer.~   "
124196|NCT01430039|"~     Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels~     of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and~     chronic inflammation due to inflammatory bowel disease.~      this protein might shed from cell surface to the serum. The investigators wish to prove that~     elevated serum levels of syndecan-1 may be predictive of disease presence, extent and~     severity, that buy taking a simple blood sample from patients diagnosed with inflammatory~     bowel disease and comparing to normal subjects and to other markers.~   "
124197|NCT01430026|"~     The propose of this study to determine efficacy and complication of gentamicin nasal~     irrigation in chronic rhinosinusitis~   "
124198|NCT01430013|"~     To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T~     cell lymphoma.~   "
124199|NCT01430000|"~     Patients who completed the conventional treatment against HCV and relapsed (the virus~     appeared again in their blood) have no effective therapy.~   "
124200|NCT01429987|"~     This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose~     ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to~     placebo in patients with Chronic Idiopathic Constipation (CIC).~   "
124201|NCT01429974|"~     Meconium constitutes the bowel contents of the fetus and is normally expelled only after~     birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium~     Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which~     complicates delivery and is associated with increased newborn morbidity and mortality. At~     present there is no viable diagnostic test for Meconium prior to the onset of labor and the~     rupture of membranes. The system developed for the detection of Meconium, based on~     recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light~     excitation at a specific wavelength. The diagnostic test being developed does not require~     penetration into the amniotic sac and is safe, painless and simple to perform.~   "
124202|NCT01429961|"~     Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with~     Advanced Hepatocellular Carcinoma~   "
124203|NCT01429948|"~     We hypothesized that paradoxical embolism may be one of the main mechanisms of silent~     cerebral infarction (SCI) located outside the perforating artery territory. In the present~     study, we evaluated the association between SCI and paradoxical embolism detected by~     agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of~     stroke or transient ischemic attack (TIA). We also compared the frequency and amount of~     paradoxical embolism between healthy subjects with SCI and acute stroke patients with~     presumed cryptogenic embolism or conventional stroke mechanisms.~   "
124268|NCT01429090|"~     The primary objective of the study is:~      •To describe extent and rate of absorption of methantheline after single oral dose~     administration of Vagantin® coated tablets (Test) in comparison to a methantheline bromide~     solution (Reference)~      The secondary objectives of the study are:~        -  To determine elimination the half-life of methantheline bromide~        -  To describe the effects of Test and Reference on salivation, accommodation, pupil~          response, blood pressure and heart rate~        -  to assess frequency and intensity of adverse drug reactions~   "
124204|NCT01429935|"~     Ginger contains constituents with pharmacological properties similar to the novel class of~     dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the~     cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer~     side effects than conventional NSAIDs and now are being investigated as a novel class of~     anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory~     components, its efficacy on acute inflammation was not assessed before. The common~     postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling,~     related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a~     crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative~     dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The~     efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in~     several clinical trials. However, NSAIDs are contraindicated in patients with~     gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a~     need for an effective, oral analgesic with a more favorable safety profile. The primary aim~     of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce~     postoperative swelling, pain and trismus in an acute pain model.~   "
124205|NCT01429909|"~     Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing~     neuronal activations during motor or cognitive tasks. The MRI sequences used are currently~     optimized for the study of cortex activations, particularly concerning the echo time~     (TE).Very few studies are interested in optimizing the fMRI for the study of the basal~     ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The~     T2 * is a tissue parameter dependent of iron content, which differs with brain structures~     and probably also with age and in case of neurodegenerative disease. Optimal TE s should~     correspond to the T2 * of studied brain structure The primary purpose is to optimize the~     fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI.~     The secondary purpose is to study the effect of age and Parkinson's disease on T2*.~   "
124206|NCT01429896|"~     Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes~     reduced quality of life due to the perceived high risk of severe reactions. Patients rely on~     accurate labeling of both loose and pre-packed foods, but these are often ambiguous and~     unhelpful. There is a common conception that labeling is 'over-cautious'. Peanut-allergic~     consumers face increasingly restricted food choices in complying with this advice due, in~     part, to the proliferation of advisory labels such as 'may contain peanuts'. This~     contributes to the reduces quality of life of affected individuals.~      For industry to provide more accurate and helpful labeling, certain characteristics of the~     food-allergic population need to be defined. Firstly, the minimum 'eliciting dose' for the~     population has been estimated by studying large groups of peanut allergic patients who are~     challenged with peanut ingestion in increasing amounts. From these, an eliciting dose that~     provokes a reaction in 10% of the food-allergic population has been estimated at between six~     and 14mg of peanut protein.~      Translation of population eliciting doses (ED) into acceptable levels of allergen~     contamination for the population requires consideration of a 'safety factor'- to account for~     individual variability in dose threshold and severity. Data suggest such variability depends~     in part on extrinsic factors (exercise and sleep restriction). Each factor may have a~     different effect in scale and direction. The investigators are proposing a cross-over trial~     with 85 peanut-allergic adults who will each undergoing a baseline peanut challenge followed~     by repeat challenges with extrinsic factors applied, in random order (repeat baseline,~     +exercise and +sleep restriction). These data will further define ED for the UK population~     and a safety factor derived from shift in threshold, to inform industry and protect the~     allergic population.~   "
124207|NCT01429883|"~     Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea~     or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned.~     During our study the investigators want to ask for pain, pain reduction and function.~   "
124208|NCT01429870|"~     Objective(s):~      (i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb~     and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50%~     loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent~     treatment.~      (ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb~     and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).~        -  Trial with medicinal product~   "
124209|NCT01429857|"~     The purpose of this study is to investigate the prognostic value of admission~     high-sensitivity troponin in patients with acute decompensated heart failure.~   "
124210|NCT01429844|"~     The purpose of the study is to compare efficacy and safety of two different~     immunosuppressive regimens for prevention of bronchiolitis obliterans syndrome (BOS)~     (chronic lung allograft rejection)after lung transplantation: tacrolimus versus~     cyclosporine, both in combination with mycophenolate mofetil and steroids. The study was~     powered to detect a 15% reduction in BOS in tacrolimus treated patients.~      Study design: open-label, randomized, comparative, multi-center, investigator driven~   "
124211|NCT01429831|"~     The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in~     outpatients with major depressive disorder who have had inadequate response to~     antidepressants in Taiwan clinical practice.~   "
124212|NCT01429818|"~     The Purpose of this study was to evaluate the effect of the combination~     glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2~     diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).~   "
124213|NCT01429805|"~     The purpose of this study is to obtain information on the safety and performance of HipJack~     Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip~     joint distraction during arthroscopy of the central compartment of the hip.~   "
124214|NCT01429792|"~     This multi-center study will evaluate the viral response in patients with chronic hepatitis~     C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon~     alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus~     daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients~     identified as slow responders/non-rapid virological responders will be eligible for an~     additional 24 weeks of treatment.~   "
124215|NCT01429779|"~     The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal~     passage through the preoperative use of Movicol.~      Hypothesis The use of Movicol® during one week prior to partial liver resection combined~     with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery~     by promoting early return of gastro-intestinal function, defined as the passage of stools~     and early oral intake.~   "
124269|NCT01429077|"~     The purpose of this study is to evaluate the effectiveness of the medication levodopa, in~     combination with speech-language treatment, on the language outcome of study subjects with~     nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and~     written language) following a stroke.~   "
124216|NCT01429766|"~     100 suitable patients of lung cancer shall be taken into the study over a period of 2 years.~     As per the existing treatment protocol in our department, all patients suitable shall~     undergo a routine Pulmonary function testing (PFT). Subsequently, recording of the breath~     hold shall be done at the following times~        1. At time of simulation~        2. At the time of first fraction of radiotherapy~        3. At mid radiotherapy~        4. At radiotherapy conclusion After the recording at a), patients shall be asked to~          perform deep breathing exercises/spirometer ball exercise to see the effect of training~          on the breath holding times.~   "
124217|NCT01429753|"~     Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms~     in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can~     help to improve LV function in patients with heart failure if those regions of the~     myocardium which are most compromised by electromechanical dyssynchrony can be identified~     and effectively stimulated. There still remains, however, a significant rate of up to 30% of~     patients who do not respond to treatment. Reasons for lack of benefit can be related to the~     inability of identifying and effectively stimulating those regions of myocardium, which are~     most compromised by electromechanical dyssynchrony. The investigators hypothesize that by~     using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and~     determine the site of latest LV activation, the investigators can find the best place to~     implant the left ventricular lead. By avoiding scar and pacing in the site of latest~     activation, the investigators believe the investigators will reduce dyssynchrony and thus~     improve overall heart function. The researchers thus aim to increase the proportion of~     people who respond to treatment. The researchers also believe that the procedure may be~     streamlined so as to reduce procedure duration, radiation dose and dose of iodinated~     contrast medium.~   "
124218|NCT01429740|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     14 days of treatment with PF-05180999 in healthy subjects.~   "
124219|NCT01429727|"~     The primary goal of this project is to describe the clinical and physiologic characteristics~     of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness,~     understanding, treatment and prevention of a potentially fatal cardiovascular event.~      This study will be a retrospective and prospective review of medical course and current~     health of men and women with SCAD.~      A prospective sub-study of echocardiographic findings after SCAD that includes perfusion~     imaging (Lumason contrast) is available to patients who are evaluated at Mayo Clinic,~     Rochester, MN. A separate consent process is included as part of this sub-study.~   "
124220|NCT01429714|"~     In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis~     (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic~     syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years.~     It is however unclear whether all patients benefit to the same extent from this therapy or~     what the optimal duration of ECS therapy for individual patients should be. ECS therapy is~     not only costly, inconvenient and demanding but sometimes also even debilitating.~     Substantial costs could be saved by tailoring therapy to individual needs and as a result~     the quality of life for individual patients can be expected to improve.~      This study aims to assess the costs and effects of tailoring the duration of ECS therapy~     after DVT to individual patients needs.~      ECS therapy with a standard duration of 24 months will be compared with tailored ECS~     therapy, following an initial therapeutic period of 6 months, in patients with acute~     proximal DVT. The primary outcome is the percentage of patients with PTS at two year~     follow-up.~      This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.~   "
124221|NCT01429701|"~     Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant~     morbidity and impaired quality of life due specially pruritus and physical visible skin~     lesions. The purpose of this trial is evaluate the effectiveness of two different topic~     associations of drugs.~   "
124222|NCT01429688|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of~     DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid)~     after multiple oral administration in healthy male volunteers.~   "
124223|NCT01429675|"~     The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg~     Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd)~     after oral administration in healthy adult volunteers.~   "
124224|NCT01429662|"~     The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR)~     technique over no MR for treating hypertension in Thai postmenopausal women.~   "
124225|NCT01429649|"~     With the advent of CT screening for lung cancer, there is an increase in the detection of~     pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass~     opacities can be caused by normal expiration, partial filling of air spaces, partial~     collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic~     proliferation of neoplasm. Precise details of the natural history of focal pure GGO are~     still largely unclear. A number of differential diagnoses are possible, including~     inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma~     in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for~     pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is~     still undecided. The major issue is whether or not the doctors should treat these patients~     at all or wait until the first sign of a solid lesion developes which may take many years.~      The purpose of this study is to determine if the ablation therapy is safe and effective for~     the pulmonary pGGO.~   "
124226|NCT01429636|"~     The purpose of this study is to demonstrate better efficacy and effectiveness of modified~     applied relaxation technique over its original version for treating menopausal symptoms.~   "
124267|NCT01429103|"~     The purpose of this study is to determine if the menopausal transition is associated with~     subjective and objective cognitive declines that ameliorate in menopause. The investigators~     hypothesize that perimenopause is associated with both subjective memory complaints and~     objective declines in attentionally mediated cognitive tasks. The investigators also~     hypothesize that this is time-limited. The investigators predict that as women transition~     from early perimenopause to late perimenopause their performance on attentionally mediated~     and verbal memory tasks will decline, and that as they transition from late perimenopause to~     menopause, their performance will improve.~   "
124227|NCT01429623|"~     The purpose of this study is to determine whether treatment with the investigational drug~     ladostigil will delay the onset of Alzheimer's disease(AD) in patients with Mild Cognitive~     Impairment (MCI). MCI is now recognized as a precursor to AD and clinical tools are~     available to assess cognitive performance at this earlier stage. Ladostigil is currently~     under investigation for the treatment of AD. In this study, the investigators will be~     examining ladostigil at a lower dose level. At this dose level, ladostigil has been shown to~     reduce signs of early memory loss in animals. Thus, in this study the investigators are~     attempting to determine if earlier invention with a lower dose of ladostigil will~     significantly reduce initial memory loss and delay the subsequent progression to more~     serious cognitive dysfunction.~   "
124228|NCT01429610|"~     The investigators would like to propose a phase-2 prospective multicenter trial evaluating~     the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute~     Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during~     induction, consolidation, and post-alloHCT status can improve the outcome in terms of~     relapse-free survival (RFS) when compared with our prior data as a historical control.~   "
124229|NCT01429597|"~     Primary objective and endpoint is the analysis of the long-term course of lyso-Gb3 and its~     clinical correlation to the progression of the cardiomyopathy in N215S-Fabry patients.~   "
124230|NCT01429584|"~     Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the~     neck, in the interscalene area, provide pain relief after shoulder surgery but can cause~     temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a~     lower concentration of bupivacaine would cause less weakness of the diaphragm but still~     provide good pain relief. Lung function and pain control was studied after interscalene~     peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.~   "
124231|NCT01429571|"~     Three patient groups with simple hand infections are tested regarding the necessity of~     antibiotics after surgical treatment.~   "
124232|NCT01429558|"~     The purpose of this project is to study live recordings from neuronal population of the~     human nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes~     for the treatment-resistant obsessive compulsive disorder (OCD). The central aim of this~     project is to determine if intra-operative electrophysiological data can confirm that the~     electrode is located in the nucleus accumbens. This confirmation could allow the placement~     of the DBS electrodes with a higher degree of precision. An additional aim of this project~     will be to study the activity of the neuronal population of the nucleus accumbens while a~     subject is presented with a task involving an unexpected reward.~      The investigators central hypothesis is that unexpected reward will be associated with~     increase firing and synchrony in the neuronal population. This will translate into~     recordable increase activity in the investigators region of interest and therefore confirm~     the proper placement of the electrode.~      This study enrolled 2 subjects, with 1 subject completing the protocol showing the~     feasibility of the experiment. There were electrophysiological variations with the task~     presented but no conclusion could be drawn given the small sample size.~   "
124233|NCT01429545|"~     The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of~     Atosiban in comparison with the combination of Atosiban and Nifedipine together.~   "
124234|NCT01429532|"~     The purpose of this study is to compare the outcomes of cataract surgery performed with~     three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).~   "
124235|NCT01429519|"~     The study objectives are to evaluate safety and efficacy of topical administration of RPh201~     oil solution (botanical extract) for treatment of patients with hard to heal chronic~     ulcerated wounds.~   "
124236|NCT01429506|"~     In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy~     with intensive medical management on weight and metabolic parameters.~   "
124237|NCT01429493|"~     In various common cancers, the skeleton is a preferred site of metastasis. These bone~     metastases are the most common cause of cancer-related pain, which significantly impair~     quality of life. It is postulated that the clinical target volume (CTV) of painful bone~     metastases consists of cancer cells and tumor-associated host cells: the tumor-host~     ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us~     to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone~     metastasis. These findings suggest the potential of intentionally non-homogenous dose~     escalation (dose painting by numbers) to improve pain control. The hypothesis is that~     fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone~     metastasis regions confined with tumor-associated host-cell compartments responsible for~     metastasis-related pain. The primary objective is to improve pain control with biological~     image-guided stereotactic body radiotherapy compared to conventional radiotherapy.~   "
124238|NCT01429480|"~     TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method~     after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest~     methods of analgesia. The researchers wish to investigate whether the TAP block is as~     effective as the ilioinguinal/iliohypogastric nerve block?~   "
124239|NCT01429467|"~     The aim of the study is to see how glycaemic control and glycaemic variability affect levels~     of HIF, VEGF, erythropoietin and cortisol in Paediatric Type 1 diabetics on insulin pump~     therapy.~   "
124240|NCT01429454|"~     The overall goal of the present study is to determine whether Omega-3 Fatty Acids~     potentially prevent onset of psychosis and improve clinical symptoms and functional outcome~     in youth and young adults at elevated clinical risk for schizophrenia and related disorders.~     The specific aims are: (1) To determine whether the rate of progression to psychosis is~     lower during six months of treatment with Omega-3 Fatty Acids compared to six months of~     treatment with placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious~     than placebo for prodromal symptoms, negative symptoms, and functioning, (3) To assess the~     safety and tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct~     analyses of neuroimaging, neurocognitive, electrophysiological and other ancillary data to~     explore mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on~     clinical and functional outcomes (e.g., increases in white matter integrity and processing~     speed).~   "
124241|NCT01429441|"~     The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion~     / (VMT) including macular hole with ocriplasmin.~   "
124243|NCT01429415|"~     Acute asthma is the most common cause of pediatric hospitalizations. While the investigators~     know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids~     substantially reduce hospitalizations, many children are resistant to this standard initial~     therapy. About a third of children remaining in moderate to severe distress after standard~     therapy are admitted to hospital and comprise 84% of pediatric acute asthma~     hospitalizations. Finding safe, non-invasive, and effective strategies to treat children~     resistant to standard therapy would substantially decrease hospitalizations resulting in~     considerable health care savings and reduction of the psycho-social burden of the disease.~     While studies of magnesium sulfate (Mg) given intravenously (IV) suggest that this agent can~     reduce hospitalizations in both adults and children resistant to standard initial therapy~     Nebulization is an alternate route for administering Mg. This route has the advantage of~     being non-invasive and is likely much safer due to lower systemic delivery. Direct delivery~     via nebulization allows higher Mg concentrations at the target site, the lower airways, with~     a smaller total drug dose. The investigators propose to conduct a properly designed study to~     clarify the role of nebulized Mg.~   "
124244|NCT01429402|"~     Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial~     rejuvenation and many other medical indications. It induces chemodenervation through its~     action on the presynaptic neuron, preventing release of acetylcholine, which leads to~     functional denervation of striated muscle for 2 to 6 months after injection. The use of~     botulinum toxin injection to reduce the facial scar is logical because this could reduce the~     tensile distracting force of the upper lip caused by the orbicularis oris muscle pull.~     Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after~     primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial~     is to compare whether post-operative peri-surgical-injection of botulinum toxin into~     bilateral orbicularis oris muscles can improve scar formation for both primary and secondary~     cleft lip surgery.~   "
124245|NCT01429389|"~     The specimen collection is designed for the purpose of the development of a noninvasive~     prenatal test for T21.~   "
124246|NCT01429376|"~     The aim of the present study is:~        1. To investigate pulmonary function abnormalities (restriction, obstruction, diffusion~          impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and~          to determine which of these pulmonary abnormalities prevail and to what extent.~        2. To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive~          pulmonary disease (COPD) as determined by spirometry and according to Global Initiative~          for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.~        3. To investigate the presence of systemic inflammation, as measured by inflammatory~          parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or~          without COPD.~   "
124247|NCT01429363|"~     The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc~     Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary~     to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be~     to prove that the treatment Group will have less disability and better quality of life.~   "
124248|NCT01429350|"~     The purpose of this trial is to assess the safety and effectiveness of the Penumbra System~     as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen~     activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the~     brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it~     does not work very well in cases where the stroke is caused by a large vessel occlusion. The~     hypothesis being tested is to determine if the addition of a treatment by a mechanical~     thrombectomy device like the Penumbra System can improve the clinical outcome of the patient~     over just using IV rtPA alone.~   "
124249|NCT01429337|"~     The purpose of this international study is to assess the effect of varying degrees of~     impaired hepatic function compared to a normal hepatic function (Child-Pugh classification)~     on the pharmacokinetics and safety of midostaurin.~   "
124250|NCT01429324|"~     This study is designed to assess the feasibility of evaluating cerebral saturation during~     critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral~     Perfusion.~   "
124251|NCT01429311|"~     Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin~     infections. A small subset of patients with AD suffer from disseminated viral infections,~     e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum~     (EV) after smallpox vaccination. Interferon gamma (IFNγ) plays a critical role in the innate~     and acquired immune responses by activating macrophages, enhancing natural killer cell~     activation, and promoting T cell differentiation, as well as regulating B cell isotype~     switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFNγ generation~     was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is~     to determine if deficient IFNγ induction leads to susceptibility to HSV infection in ADEH+~     patients.~   "
124252|NCT01429298|"~     In this randomized controlled trial, 2 mg IV hydromorphone will be more efficacious than~     usual care (usual care is analgesic management according to the judgment of the attending~     physician caring for that patient) in emergency department (ED) patients aged 21-64 years.~     The primary efficacy outcomes are the proportion of patients in each arm who choose to forgo~     additional pain medication in 30 minutes of entry into the study and the change in NRS pain~     scores from baseline to 30 minutes post baseline.~   "
124253|NCT01429285|"~     The hydromorphone protocol is more effective than usual care in Emergency Department (ED)~     patients age 65 years and older in terms of proportion who choose to forgo additional pain~     medication within 60 minutes post-baseline in the two groups.~   "
124254|NCT01429272|"~     The purpose of this study is to determine whether Minocycline and aspirin are effective in~     the treatment of depression in Bipolar patients.~   "
124255|NCT01429259|"~     This study will determine the concentrations of the antibiotic meropenem when administered~     as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an~     acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour~     infusion will be measured.~   "
124270|NCT01429064|"~     The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with~     castrate resistant prostate cancer.~   "
124256|NCT01429246|"~     The study was a single-blind randomized controlled trial conducted between February and~     August 2009 in two townships (Yangbajing and Gongtang) of Dangxiong County, an area at 4300~     meters altitude in Tibet. A brief baseline survey and assessment for eligibility was~     performed before randomization. A total of 282 residents with known hypertension (systolic~     blood pressure ≥ 140mmHg) were recruited and randomly assigned to intervention or control~     with stratification by gender and baseline blood pressure. The intervention group received~     6-month's supply of salt substitute (68% sodium chloride, 22% potassium chloride and 10%~     magnesium sulfate heptahydrate) and the control group 6-month's supply of regular salt (100%~     sodium chloride). After 3-month's intervention, the ones with a blood pressure above 140~     mmHg / 90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. The~     study hypothesis is that salt-substitute will greatly reduce blood pressure in treated~     patients when compared to controls. Blood pressure levels were measured at baseline and~     followed up by trained observers using an automated sphygmomanometer and brief survey on~     level of compliance, amount of salt consumed, and reasons for non-compliance.~   "
124257|NCT01429233|"~     This is a Phase 4, observational, open study in patients whom their doctor for clinical~     practice prescribes levamlodipine. No medication was provided by the sponsor. The planned~     observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline~     followed by information gathered from the assessment visits at week 4 and week 8, or~     clinical practice.~   "
124258|NCT01429220|"~     The purpose of this study is to evaluate the utility of a portable motion sensor-based~     system designed to assist with deep brain stimulation (DBS) programming sessions for~     Parkinson's disease patients.~   "
124259|NCT01429207|"~     The purpose of the study is to test whether body-worn wireless motion sensors can measure~     dyskinesias (involuntary movements caused by medications) in individuals with Parkinson~     disease (PD) independent of voluntary activity being performed and other PD motor symptoms~     (e.g. tremor).~   "
124260|NCT01429194|"~     The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using~     endoscopic guidance to trans-orally place plications in the stomach in obese subjects to~     reduce volume and expansion of the fundus and greater curve to abate hunger as part of a~     supervised weight reduction program.~      The primary objective of this study is to perform an evaluation of the safety of the~     plication procedure.~      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE~     Stapler for the treatment of obesity over a 24 month follow-up period.~   "
124261|NCT01429181|"~     There is a growing evidence that the d-isomer of methadone is effective in treating~     neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone~     for treating somatic pain. This study will examine a combination of different amounts of the~     d- and l-isomers of methadone specifically tailored to the chronic peripheral neuropathic~     pain. Non-racemic mixture of methadone isomers will be tested in this pilot efficacy and~     safety study.~      This study will evaluate effect of the three doses of the non-racemic mixture of methadone~     hydrochloride patients with chronic peripheral neuropathic pain compared with a placebo. The~     study will also examine the minimally effective and maximally tolerated doses of the~     non-racemic mixture of methadone. Finally, the safety and tolerability of the non-racemic~     methadone therapy will be evaluated.~   "
124262|NCT01429168|"~     This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in~     participants with osteoarthritis who are experiencing inadequate response to their current~     treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily.~     Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily~     within two weeks will be eligible to enter the double-blind withdrawal period (Part II).~     Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60~     mg or placebo.~   "
124263|NCT01429155|"~     Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a~     national organ shortage, living donor liver transplantation has became a viable option for~     patients with end stage liver disease who are not severely ill. Recently particular~     polymorphisms of IL-28B gene were reported to correlate with histological recurrence and~     antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar~     results have not been described yet in living donor liver transplant patients.~      There is data suggesting slightly inferior outcomes in living donor liver transplants when~     done for hepatitis C. The investigators postulate that such inferior outcomes may be related~     to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive~     similarly unfavorable polymorphism livers from their relatives).~   "
124264|NCT01429142|"~     The objectives of the main study are to evaluate the effectiveness and the~     cost-effectiveness of a counseling intervention to support medication intake among patients~     treated for HIV. The aim is that through the availability of medication intake reports~     collected through electronic monitoring, more adherence problems can be identified and~     medical decision-making improves.~      A substudy focuses on the broader range of nursing care in HIV-treatment, examining the~     content of care delivered to support physical, mental, sexual and social well-being; whether~     the delivery of the AIMS intervention affects the quality of care on domains other than~     adherence; and whether the content of care on these various domains can be linked to patient~     well-being and satisfaction.~   "
124265|NCT01429129|"~     This study will examine the efficacy of mailed distribution of free Nicotine Replacement~     Therapy to smokers. Telephone numbers will be randomly selected from across Canada in order~     to recruit adult smokers interested in completing a smoking survey and willing to be~     interviewed again in 8 weeks and 6 months time. Study participants will be asked about their~     smoking history and a hypothetical question: would they be interested in receiving the~     nicotine patch if this were to be provided to them free of charge? Participants expressing~     interest will be randomly assigned to one of two groups. One group will be offered the~     opportunity to actually receive a program of 5 weeks of the nicotine patch for free right~     away and the other group will not be offered the free nicotine patches. The proportions of~     smokers in the two groups who quit smoking by the 6-month interview will be compared.~   "
124266|NCT01429116|"~     The purpose of this study is to evaluate the safety of tasimelteon in male and female~     patients who suffer from Non-24-Hour Sleep-Wake Disorder.~   "
124987|NCT01419665|"~     The purpose of this study is to demonstrate comparability of the ORR in patients with~     previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive~     MabThera-treatment.~   "
124272|NCT01429038|"~     The immune system of a patient can attack the liver or the kidney received from a donor~     (organ rejection). This can be prevented by treating these patients long-life with~     immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail~     to prevent the rejection occurring months later after the transplantation (chronic~     rejection). Recently, it has been shown that a particular type of cells present in the bone~     marrow, namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune~     system and increase success rates of blood cells transplantation. This outcome opens doors~     to investigate the potential of these cells to provide a valuable tool for improving solid~     organ transplantation without the need of high concentration of immunosuppressive drugs. The~     present project aims at evaluating the safety and tolerability of MSC administration after~     liver or kidney transplantation.~   "
124273|NCT01429025|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer~     cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma~     by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and~     bendamustine hydrochloride may kill more cancer cells.~      PURPOSE: This phase I trial studies the side effects and the best dose of giving~     lenalidomide together with rituximab and bendamustine hydrochloride in treating patients~     with refractory or relapsed indolent non-Hodgkin lymphoma.~   "
124274|NCT01429012|"~     Bone fractures heal most of the time particularly well and without complications. The~     solidification takes rarely more than two to three months. The wound healing depends greatly~     on a good blood supply and needs several steps. These processes culminate in a new mass of~     heterogeneous tissue which is known as the fracture callus. Unfortunately, 2%-5% bone~     fractures cannot achieve a proper solidification and between the ununited fragments a scar~     tissue appears. This incorrect healing induces pain and even infections. When this situation~     persists more than 6 months, it is referred to as nonunion fracture, which will require some~     form of intervention to stimulate the natural healing process of the body. First of all,~     good surgical techniques with stable immobilization should be applied and local infection~     should be excluded. Then stimulation of the callus is required. Cell therapy with bone~     marrow cells has emerged as a promising new approach for bone regeneration. Animal studies~     as well as preliminary human studies have shown that Mesenchymal Stem Cells, a particular~     kind of stem cells isolated from the bone marrow, could induce callus formation when~     injected in the nonunion site of a broken bone.~      In this study the investigators aim at determining whether Mesenchymal Stem Cells (MSC)~     isolated from the patient's bone marrow and injected in the nonunion site could be a safe~     and effective treatment for nonunion fractures. Patients will be randomized in two groups;~     one injected with Mesenchymal Stem Cell and the other injected with placebo. The~     investigators seek also to know how long it takes to develop the callus formation and~     whether there is a partial or a complete callus formation.~   "
124275|NCT01428999|"~     The purpose of this study is to evaluate the effect of combined probiotics to improve the~     gastrointestinal function and intestinal bacteria flora~   "
124276|NCT01428986|"~     This study is to investigate the safety of maraviroc by examining whether there is bone~     metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone~     mineral density and markers for bone formation, desorption and chemokine.~   "
124277|NCT01428973|"~     The present project is a multicenter phase II trail aiming at comparing which of the two~     postgrafting immunosuppressive regimens proposed in this study will be best suited to~     prevent graft-versus-host disease (GVDH).~      The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or~     Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity~     conditioning with Fludarabine/total body irradiation (TBI) or~     Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014,~     the protocol has been amended to allow inclusion only after Flu-TBI conditioning. The~     hypothesis is that the Tacrolimus plus Sirolimus regimen will be associated with better~     progression-free survival due to a lower incidence of relapse/progression.~   "
124278|NCT01428960|"~     To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and~     inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic~     responses in healthy adult subjects.~      Study hypothesis: The degree of fat saturation does not affect postprandial lipemia,~     haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety~     responses in health adult subjects.~   "
124279|NCT01428947|"~     The purpose of the study is to study if coronary angiography cause cognitive dysfunction.~   "
124280|NCT01428934|"~     Cardiovascular risk functions fail to identify more than 50% of patients who develop~     cardiovascular disease. This is especially evident in the intermediate-risk patients in~     which clinical management becomes difficult. The purpose of this study is to analyze if~     ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose,~     glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are~     independently associated to incidence of vascular events and whether they can improve the~     predictive capacity of current risk equations in the intermediate-risk population.~   "
124288|NCT01428817|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most common uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which~     requires a continuous infusion to achieve sustained uterotonic activity. The Society of~     Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg~     dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent~     post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin~     lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent~     greater efficacy rate. However, a dose response to determine the minimum effective dose of~     carbetocin has not yet been published. The investigators hypothesize that the minimum~     effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean~     delivery.~   "
125048|NCT01418859|"~     The purpose of the research is to evaluate the effect of additional chemotherapy in~     postoperation therapy of cervical cancer patients with risk factors (big tumor, deep~     invasion or tumor thrombi in the vascular system).~   "
124281|NCT01428921|"~     Obstructive sleep apnea (OSA) is a common sleep disorders associated with excessive daytime~     sleepiness and cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is~     an effective standard treatment and is widely prescribed for patients with OSA. Successful~     CPAP treatment has also been shown to improve cognitive, cardiovascular and metabolic~     function. Sustainable CPAP treatment would alleviate the substantial cost burden of~     health-related consequences of untreated OSA.~      However, the use of CPAP for such patients is disappointingly low and limits the~     effectiveness of treatment. Early CPAP education and follow up have shown to be very~     important in helping subjects to handle side-effects or problems associated with the use of~     CPAP. Good education program at the initial phase of using CPAP is essentially affected the~     acceptance and adherence of CPAP therapy. Good CPAP adherence is not only medically~     essential to patients' health but also economically importance to society by alleviating the~     substantial cost burden of health-related consequences.~      To the best of our knowledge, there is no randomized clinical trial (RCT) to prove the~     long-term efficacy of extended education program on improving continuous positive airway~     pressure use and its treatment outcomes.~      The primary purpose of this study is to assess the long-term efficacy of our on-going RCT~     which is an extended education program on improving CPAP compliance.~      The investigators hypothesize that the application of both MI technique and SCT-based~     extended education program at the initial phase of using CPAP also would enhance CPAP~     adherence even after one year of attending education class.~   "
124282|NCT01428908|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine~     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection~     caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the~     infant's normal immune programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age~     of two, and the remaining 60% with a low antibody level and a short duration.~      According to the present immunization schedule, to reach the median level of antibody levels~     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,~     to provide high levels of long-term protection and to reduce the number of injections.~      After the phase I study which was conducted in August, 2011, the safety profile of this~     vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the~     safety and the immunization of the vaccine. The objective of this study is to evaluate the~     safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal~     conjugate vaccine.~   "
124283|NCT01428895|"~     Bone is a common site of metastasis for a range of malignancies. Bone metastases have the~     potential to cause significant morbidity including pain, impairment of ambulation and~     reduced functional independence. Previous research has shown that pathological fractures are~     observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of~     these require surgical intervention to relieve pain and restore function.~      The goal of this study is to describe the clinical outcomes of patients with femoral~     metastases at high risk of pathological fracture. Patients referred for treatment of femoral~     metastases at high risk of fracture will be followed prospectively after undergoing with~     surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease~     characteristics, ambulatory status and limb function will be documented before treatment.~     These Clinical outcomes of participants in each treatment group will be measured 6 weeks~     after treatment, and 3- and 6 months after enrolment, with particular reference to~     patient-reported outcomes relating to pain, ambulatory status, limb function and quality of~     life.~   "
124284|NCT01428882|"~     Nonanesthesiologist administration of propofol for sedation is actually a field of growing~     interest for endoscopists, as demonstrated by recent American and European guidelines on~     this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a~     single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation~     (BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be~     successfully titrated to moderate sedation. However, nonanesthesiologists propofol~     administration remains controversial on account of the possibility of deep sedation/general~     anesthesia related adverse events. On the other hand, the use of longer elimination~     half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and~     recovery.~      Up to date, no study has addressed a head-to-head comparison of both regimens administered~     by non-anesthesiologists and titrated to moderate sedation.~      This study aims to evaluate the impact on propofol sedation of premedication with a fixed~     dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate~     sedation, in terms of depth of sedation, recovery times, safety and satisfaction.~      The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak~     effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts~     a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam~     may increase the depth of sedation through the initial phases of the procedure, diminishing~     propofol requirements, but not prolonging significantly recovery times.~   "
124285|NCT01428869|"~     The purpose of this study is to assess whether there is any interaction between statins,~     acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the~     development of high grade prostate cancer, or lower urinary tract symptoms.~   "
124286|NCT01428843|"~     Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease.~     This is due to iron deficiency and inflammation.~      Most of treatments aim to control inflammation using anti-TNF alpha therapy which should~     theorically reduce anemia.~      The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should~     reduce anemia and improve quality of life of patients.~   "
124287|NCT01428830|"~     This facility-based, multi-center randomized controlled trial (RCT) will test the~     non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14~     day) urethral catheterization in terms of predicting fistula repair breakdown three months~     following urinary fistula repair surgery. The study will be conducted among 507 women with~     simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.~   "
124290|NCT01428791|"~     Linkages between depression and cardiovascular disease have been well documented. These~     appear to be more than associations, and may reflect causal relationships through a number~     of proposed pathways, including decreased physical activity, poor dietary habits, medication~     non-adherence, and a direct impact on inflammatory mediators. Older adults are affected by~     both depression and heart disease, with increased risk in African American and Latino~     elderly.~      The BRIGHTEN-Heart trial tests the hypothesis that an enhanced primary care delivery system~     intervention which provides evidence-based, patient-centered mental health services~     targeting depression and cardiovascular risk factors can reduce the risk of development of~     cardiovascular disease in low-income elderly blacks and Hispanics. BRIGHTEN stands for~     Bridging Resources of a Geriatric Health Team via Electronic Networking, and in this~     intervention, specialty providers including geropsychologists, social workers, pharmacists,~     nutritionists, chaplains, occupational therapists, and others collaborate via the internet~     as a virtual team. The study will determine if such a virtual interdisciplinary clinical~     team collaboration can reduce depression in older (age ≥ 65) minority adults with comorbid~     depression and metabolic syndrome.~   "
124291|NCT01428778|"~     This prospective observational study will investigate the frequency of new onset atrial~     fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent)~     cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.~   "
124292|NCT01428765|"~     This study constitutes Phase I of the Registry Program. The main objective of this study is~     to characterize the newly diagnosed non-valvular AF patient population at risk for stroke~     and the selection of antithrombotic treatment for stroke prevention in a real-world setting~     before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in~     patients with non-valvular AF in different regions of the world.~   "
124293|NCT01428752|"~     Current guidelines for initiating screening colonoscopies in patients younger than 50 years~     of age who have a first relative history of colorectal cancer are controversial. The aim of~     this study was to prospectively define the prevalence of colorectal adenoma 30- to~     49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to~     compare the data with controls.~      Design: Single-center prospective study~   "
124294|NCT01428739|"~     Correlation between MRS and Tumor Response Therapy in Breast Cancer.~   "
124295|NCT01428726|"~     The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of~     relapsing remitting multiple sclerosis, comparing two doses versus placebo.~   "
124296|NCT01428713|"~     Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women,~     is encountered even more frequently in adolescents. Surveys of school students in the United~     States (US) and Europe reported menorrhagia in 37% to 55% of adolescent females. Medical~     management of adolescent menorrhagia includes various formulations of hormonal therapy and~     the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more~     potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in~     adolescent women in Europe and Canada, was not previously available in the US. Subsequent to~     US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy~     menstrual bleeding in adult women, this medication is currently included in the treatment~     armamentarium for adult menorrhagia. There is currently no preliminary data available in the~     US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia.~     Oral contraceptive pills (OCP) are considered standard therapy in the management of~     menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than~     progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data~     available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in~     adolescents with menorrhagia.~      The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable~     efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when~     compared to the commonly prescribed COCP.~      This hypothesis was tested by comparing the efficacy of these two medications, in a~     prospective randomized crossover trial in post-menarchal young girls with menorrhagia.~   "
124297|NCT01428700|"~     Acute cellular rejection is relatively common after liver transplantation, typically does~     not affect graft survival, and is not associated with the development of chronic rejection.~     Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are~     elevated when compared to baseline. The only means of differentiating acute rejection from~     other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic~     procedure, it may be difficult to distinguish acute rejection from another disease process,~     such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will~     evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue~     of a liver transplant recipient can be used to determine if the transplanted liver is being~     rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific~     for acute rejection and informative of the severity of HCV recurrence could allow for~     modulation of immunosuppression therapy and treat the clinical condition without the need~     for invasive liver biopsies.~   "
124298|NCT01428687|"~     A series of studies are proposed to develop an intervention to increase sleep duration and~     study the effects on eating, exercise, and weight control. The hypothesis is that increasing~     sleep duration will help improve weight loss and maintenance.~   "
124299|NCT01428674|"~     The purpose of this study is to describe the onset, duration and dose-response of~     interpersonal mindful compassion on respiratory rate and heart rate variability in healthy~     adults in order to prepare for research evaluating the impact of this intervention in~     patient populations and to prepare for basic research investigating the CNS mechanisms for~     observed effects.~      Previous research has found that mindfulness meditation, including mindful compassion,~     results in autonomic changes in the practitioner. Emerging neuroscience of dyadic~     interactions suggests that through the effects of mirror neuron isopraxis, one person's~     physiologic state may be mirrored by another. However, no research has directly evaluated~     the impact of one person's mindful compassion on another person's autonomic activity. This~     study paves the way for an entirely new avenue of research inquiry.~   "
124300|NCT01428661|"~     The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked~     treatment of tasimelteon or placebo in male and female subjects with Major Depressive~     Disorder.~   "
124301|NCT01428648|"~     Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor~     tasks, affects quality of life and has been associated with depression. The purpose of this~     study is to investigate the effect of dance therapy on motor performance, quality of life~     and depression in PD patients, by comparing certain symptoms between a group of subjects~     with PD who undergo ballroom dancing classes and a control group of subjects with PD. The~     investigators will assess mental status, severity of PD, quality of life and depression~     using rating scales. Subjects will be randomized to intervention and control group.~     Intervention group will participate in dance therapy for 12 weeks and will be examined at 12~     and 20 weeks. Control group will be examined at same time intervals. Classes will follow a~     curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate~     significant risk for participants.~   "
124302|NCT01428635|"~     The goal of this clinical research study is learn if eltrombopag can help control or prevent~     low platelet counts in patients receiving treatment for CML or myelofibrosis.~   "
124303|NCT01428622|"~     The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose~     combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic~     exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).~   "
124304|NCT01428609|"~     The aim of this study is to determine the blood's mercury level of patients who had amalgam~     root end filling surgeries. It is to be examined if the mercury concentration in blood is~     elevated by using amalgam retroseal.~   "
124305|NCT01428596|"~     This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The~     safety and immune responses will be studied in vaccine recipients. The anti-viral effect of~     HIVAX vaccine will be monitored during a 12-week treatment interruption phase.~   "
124306|NCT01428583|"~     The study will provide information to assess the benefits versus risks of extended exposure~     to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain~     population.~   "
124307|NCT01428570|"~     The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect~     laryngoscope which has an integrated tube passage function. Pentax-AWS improved the~     laryngeal view and facilitated tracheal intubation in patients with restricted neck motion.~     The purpose of this clinical trial was to evaluate the relative efficacy of the AWS~     laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome~     (OSAS) patients and to compare its performance with the Macintosh laryngoscope.~   "
124308|NCT01428557|"~     The purpose of this study is to evaluate the demographic, clinical, prognostics~     characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart~     failure in a group of 60 hospitals representative in different regions.~   "
124309|NCT01428544|"~     The purpose of this post-marketing surveillance study is to collect and assess information~     retrospectively on safety and effectiveness of fondaparinux injection in patients with~     venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom~     fondaparinux was injected 10 mg/day.~      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)~   "
124310|NCT01428531|"~     The purpose of this post-marketing surveillance study is to collect and assess information~     on safety and efficacy of fondaparinux injection in patients with venous thromboembolism~     (VTE).~      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)~   "
124311|NCT01428518|"~     This post-marketing surveillance study is designed to collect and assess information on~     safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine~     clinical practice.~      (LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)~   "
124312|NCT01428505|"~     This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial~     activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with~     PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender-~     matched healthy volunteers.~   "
124313|NCT01428492|"~     Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with~     bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one~     line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the~     combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3~     mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety,~     tolerability and clinical activity of the MTD(s) identified in Part 1, including a~     pharmacokinetic cohort.~   "
124314|NCT01428479|"~     This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete~     crossover, single and multiple dose study in healthy Japanese male subjects to assess the~     pharmacokinetics and safety/tolerability of single and multiple intravenous administration~     of GR121167. Serial blood samples and pooled urine samples for the determination of GR121167~     concentration will be collected and safety assessments will be performed for each treatment~     period.~      The pharmacokinetics and dose proportionality of GR121167 after single intravenous~     administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed.~     In addition, in the final treatment period (600 mg), twice daily intravenous administrations~     for 5 days will be also conducted and the pharmacokinetics and accumulation will be~     assessed.~   "
124315|NCT01428466|"~     This is a randomized, single-center, partial-blind study to evaluate the dermal irritation~     potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl~     peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled~     water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese~     healthy male and female volunteers. Finn-Chambers containing no investigational product will~     be applied in the same manner.~      Safety will also be assessed by measurement of vital signs, electrocardiograms, safety~     laboratory data and review of adverse events.~   "
124316|NCT01428453|"~     The study is designed to investigate the effects of rilapladib on biomarkers related to the~     Alzheimer's disease, and cognitive function.~   "
124318|NCT01428427|"~     MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study. The~     primary objective of the study is to determine the recommended dose and regimen for the~     orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in~     subjects with solid tumors.~   "
124319|NCT01428414|"~     The purpose of the investigators study is to compare the efficacy and safety of combining~     trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant~     therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would~     be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed~     by operation and adjuvant treatment. The main end point of this study would be the efficacy~     and safety of the two treatment arms, and the trend of the two curves is anticipated.~   "
124320|NCT01428401|"~     Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of~     studies have known that AM can reduce cerebral infarction area and has anti-oxidation.~     Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase~     intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present~     study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators~     selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were~     randomly divided into control and experimental groups, and each group was 40 patients as~     follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for~     continuously 14 days from second day of admission or operation, except standard ordinary~     treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days~     from second day of admission or operation, except standard ordinary treatment. Computer~     tomography (CT) examination was done at first day, 4th day and 7th day of admission,~     respectively. The ratio of brain edema was calculated by CT image, and inflammatory index~     including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate~     (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In~     addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS),~     Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks~     and 12 weeks after admission or surgical operation, as an index for clinical symptoms. The~     index for the therapeutic effect of AM was according to above-mentioned the ratio of brain~     edema, inflammatory index and clinical symptoms.~      The investigators expected the results of the present study may provide a scientific~     evidence for the hemorrhagic stroke edema treatment of AM, thus, the present study may~     contribute to use the method of integrated Chinese and Western Medicine for the treatment of~     stroke, and to the research of Chinese Medicine.~   "
124321|NCT01428388|"~     Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in~     treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most~     widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been~     FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used~     off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab~     is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month~     randomized, prospective interventional trial comparing the effectiveness of ranibizumab with~     bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change~     in central retinal thickness. Secondary measures are change in visual acuity from baseline~     and change in angiographic properties of macular lesions from baseline after treatment.~   "
124322|NCT01428375|"~     This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of~     Paracetamol as intrapartum analgesic in the first stage of labour.~   "
124323|NCT01428362|"~     The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and~     effective as a daily treatment for Alzheimer's disease that is worsening despite current~     treatment.~   "
124324|NCT01428349|"~     This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez)~     that examines whether recent progress in characterizing the cognitive deficits associated~     with psychopathic and externalizing offenders may be used to develop better therapeutic~     interventions to treat their substance abuse and other self-control problems. Inmates with~     externalizing or psychopathy will receive one of two computer-based interventions to~     remediate the core cognitive skills that have been linked to self-regulation deficits in the~     two groups. One intervention (ACC) targets the affective cognitive control deficits~     associated with externalizing offenders whereas the other intervention (ATC) targets the~     attention to context deficits associated with psychopathic offenders. The specific~     components of the project include: selection and randomization of inmates; pre- and~     post-treatment behavioral and brain-related (ERP and Startle) measures to evaluate the~     impact and specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g.~     computerized) and verbal training in ACC or ATC.~   "
124325|NCT01428336|"~     The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An~     optimal test should have a very low margin of error with high sensitivity and specificity,~     be easy and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses~     have their limitations. Based on our experience over the past six years, we hypothesize that~     25 ug ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and~     SDST (250 ug). This is supported by our preliminary data and the study by Oelkers et al,~     which looked at ACTH levels following various doses of cortrosyn injections.~      Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as~     gold standard.~   "
124326|NCT01428323|"~     Open-vent jet nebulizers are frequently used to promote drug lung deposition but their~     clinical efficacy and indications are not clear.~      Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet~     nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a~     110 ml corrugated piece of tubing.~   "
124327|NCT01428310|"~     This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the~     effects of study product on a smoker's desire to smoke, measured by changes in scores on~     questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will~     self-administer the study product and visit the study site for assessment of desire to smoke~     and collection of samples for the evaluation of smoking-related biomarkers.~   "
124328|NCT01428297|"~     The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in~     Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will~     be assessed in two different patients groups to evaluate safety and efficacy in atopic~     dermatitis (Part 2) and in Netherton syndrome (Part 3).~   "
124329|NCT01428284|"~     The purpose of this study is to assess the effects of multiple doses of probenecid on the~     multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers.~     Safety and tolerability will also be assessed.~   "
124340|NCT01428141|"~     The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK),~     pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily~     to patients with advanced solid tumor and gastric cancer.~   "
124352|NCT01427985|"~     The purpose of this study is to examine the influence of premedication drugs Atropin,~     Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac~     output in term and preterm newborn infants. Two different protocols of premedication are~     compared.~   "
124330|NCT01428271|"~     Caudal block is one of the most useful and popular regional block in pediatric anesthetic~     practice. Successful caudal block depends on the proper placement of a needle through sacral~     hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are~     extreme variable anatomical structure. Generally, the equilateral triangle located between~     the apex of the sacral hiatus and posterior superior iliac spines is used in determining the~     location of the sacral hiatus as the conventional method. Previous study demonstrated that~     the triangle formed between the apex of the sacral hiatus and the posterior superior iliac~     spines was found to have the features of an equilateral triangle in adult. There is no study~     about the efficacy of the conventional method using the equilateral triangle in children. In~     this study, the investigators will compare between the expected site of sacral hiatus by~     conventional method using the equilateral triangle and the real site of the sacral hiatus~     confirmed by ultrasonography for caudal block in children.~   "
124331|NCT01428258|"~     For individuals with Phenylketonuria (PKU), the investigators hypothesize that~     glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that~     will improve dietary compliance, blood phenylalanine levels, cognitive function, and~     ultimately quality of life compared with the usual amino acid based diet. The study is~     funded by the Food and Drug Administration (FDA) Office of Orphan Products Development~     Grants Program, R01 FD003711.~   "
124332|NCT01428245|"~     Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the~     pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone~     (FSH). LH and FSH control the production of female hormones (such as estrogen and~     progesterone) and the development of eggs by the ovary. Progesterone and estrogen then~     decrease the number of GnRH pulses produced by the brain (and therefore the number of LH~     pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important~     for normal menstrual function in adult women. The purpose of this study is to learn more~     about how GnRH and LH pulses are controlled during puberty. The information gathered in this~     study will hopefully allow us to learn more about how menstrual cycles are normally~     established in girls during puberty.~   "
124333|NCT01428232|"~     A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo~     to compare rates of early initiation and exclusive breastfeeding between mothers who give~     birth in hospitals with the current standard of care, mothers who give birth in hospitals~     that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and~     mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly~     Hospital Initiative, with the 10th step being the provision of breastfeeding support during~     well-child clinic visits.~   "
124334|NCT01428219|"~     The purpose of this study is to look at the effects of cabozantinib on castrate-resistant~     prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone~     and to learn about any side effects caused by taking cabozantinib.~   "
124335|NCT01428206|"~     Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care~     practice from the hospice setting to the hospital setting in UK. LCP is a pathway with~     standardized registration method to monitor the care and its results. The primary aim is to~     study the effects of LCP on dying patients symptom burden and communication with close~     relatives and health care professionals.~   "
124336|NCT01428193|"~     The purpose of this study is to understand the effects of elevated male hormones in~     adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If~     the investigators understand the effects of elevated male hormones levels in girls, the~     investigators may be able to better treat girls with elevated male hormone levels and~     perhaps even learn how to prevent the development of PCOS. Females with elevated levels of~     male hormones respond differently to estrace (estradiol) and progesterone than females with~     normal male hormone levels. The investigators will be giving you estrogen and progesterone~     to see how you respond after the male hormone has been blocked by a medication called~     flutamide.~   "
124337|NCT01428180|"~     The purpose of this study is to examine the influence medical or surgical treatment for~     patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on~     cardiac output.~   "
124338|NCT01428167|"~     Thyroid cancer (TC) is the most common endocrine malignancy. The association between~     inflammation and cancer is well established but the association between thyroiditis~     (inflammation of thyroid gland) especially Hashimoto's thyroiditis (HT) and thyroid cancer~     remains controversial. Chronic inflammation leads to a repeated cycle of cellular damage and~     subsequent healing which contributes to inappropriate cell proliferation and subsequent~     neoplastic transformation. One of the most common forms of Thyroiditis is Hashimoto's~     thyroiditis which is a chronic autoimmune inflammatory disease affects almost 5% of the~     population and is more common in women. For the first time, Dailey and Lindsay reported in~     1955 an increased association between Hashimoto's Thyroiditis (HT) and thyroid cancer. They~     reported 35 thyroid cancers in 278 patients with Hashimoto's Thyroiditis, a prevalence of~     17.7% which they considered higher than the general population . Since then, various studies~     have been done, some studies have reported an increased risk of malignancy in Hashimoto's~     thyroiditis; others have failed to find an association. Most of the studies that have been~     done to identify the association between Hashimoto's thyroiditis and thyroid cancer are~     retrospective. The purpose of this pilot case-control study is to identify the association~     of Hashimoto's thyroiditis and thyroid cancer, to determine if the presence of Hashimoto's~     thyroiditis has any affect on the complication of thyroidectomy and prognostic factors of~     thyroid cancer.~   "
124339|NCT01428154|"~     The purpose of this study is to find out more about darbepoetin alfa in children less than 1~     year of age with anemia (a decrease in red blood cells) due to kidney failure. This study~     will see if darbepoetin alfa is safe and well tolerated and whether it causes any side~     effects by taking blood samples and checking vital signs (heart rate, body temperature, and~     blood pressure tests) at specific times throughout the study. In addition, the study will~     evaluate the amount of darbepoetin alfa in the blood over time and look at special markers~     in the blood to evaluate how darbepoetin alfa works on anemia.~      Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and~     European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric~     subjects. Therefore, studies need to be conducted in pediatric subjects (children) to~     determine the appropriate dose to use in younger children.~   "
124341|NCT01428128|"~     Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These~     forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety~     of side effects. There are many side effects of chemotherapy. A few examples are: lowered~     red blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath;~     lowered white cell counts (white blood cells which help the body to fight infection); low~     platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth~     sores and hair loss. These side effects can range from mild to severe. P53 is a protein in~     the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or~     radiation treatment, the p53 protein becomes activated. This activation can cause the cell~     to die and is involved in causing side effects from chemotherapy or radiation therapy.~      Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug~     Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of~     blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical~     studies have shown that when given in smaller than normal doses before treatment with~     chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53~     and protect normal tissues from treatment damage. Preclinical means that the studies have~     been done in a laboratory and not on humans.~      This study has two purposes. The first is to find the dose range for arsenic trioxide that~     will block p53 activity. This dose has been determined from the first five subjects who took~     part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study~     is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute~     promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side~     effects of chemotherapy. In this study, arsenic trioxide is investigational.~     Investigational means that arsenic trioxide has not yet been approved by the FDA to block~     p53 activity.~      This study will help find out what the smallest (best) dose is that can be given and the~     effects, good and/or bad, this drug has on people who take it. The safety of this drug in~     humans has been tested in prior research studies; however, whether the side effects will~     still be present at this lower dose is not yet known.~   "
124342|NCT01428115|"~     It has been shown that emotional health issues, such as state anxiety, are more prevalent in~     patients suffering from inflammatory bowel disease (IBD) compared to physically healthy~     subjects.~      Such findings have to be taken into consideration when making an educated guess that~     psychological factors such as depression and anxiety in particular interact with the course~     of Crohns disease. Therefore the treatment of the underlying disease may have a significant~     influence on the level of psychological disorders.~      Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α)~     antibodies ameliorates the emotional/psychological status of patients, however the impact of~     adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD)~     remains unclear.~      The primary objective of this study was to describe and evaluate changes in levels of~     anxiety assessed by validated patient questionnaires after 6 months of treatment with~     adalimumab.~   "
124343|NCT01428102|"~     During normal physiological conditions hemostasis (the ability of blood to clot) is kept in~     homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex~     series of steps on both sides of the coagulation cascade including cellular components (i.e.~     clot formation and breakdown). However, should this homeostatic balance be upset, normal~     hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding~     (hemorrhage). In instances that include acquired or congenital abnormalities of the~     hemostatic system it is clinically important to diagnose, monitor and manage the patient to~     optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis~     system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain~     the homeostatic balance.~      The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets~     with the protein coagulation cascade from the time of placing the blood in the analyzer~     until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via~     GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively~     the two distinct parts of hemostasis - the part that produces the clot and the part that~     causes the breakdown of the clot. It shows the balance or degree of imbalance in the~     patient's hemostasis system, highlights any areas of deficiency or excess, and offers a~     precise view of the patient's hemostasis condition. If the system is not in balance, one can~     see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause~     of bleeding as soon as possible in order to start the proper treatment.~      By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the~     interaction and simultaneous contribution of the intrinsic and extrinsic coagulation~     pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver~     results faster than activating with Kaolin alone. This protocol will specifically assess one~     algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and~     platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot.~     This represents platelet function.~      The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs.~     MA Kaolin.~   "
124344|NCT01428089|"~     During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH),~     luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are~     very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they~     initially do so at night only. It is unknown why GnRH and LH pulses increase at night and~     then decrease during the day (instead of being increased all the time). The purpose of this~     study is to see how quickly progesterone reduces LH pulses. The study is also meant to find~     out whether too much testosterone (also a hormone) in the blood causes problems with the~     ability of progesterone to reduce LH pulses. In this study, the investigators aim to~     discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent~     the nighttime increase of LH pulses. From the information gathered in this study, the~     investigators may be able to learn more about how menstrual cycles are normally established~     in girls during puberty. Ultimately, if the investigators understand these normal processes,~     the investigators may be able to better understand abnormalities of puberty.~   "
124345|NCT01428076|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the pharmacokinetic profile~     of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM),~     an investigational treatment for varicose veins.~   "
124346|NCT01428063|"~     The purpose of this study is to provide anti-hepatitis C virus drugs to patients who~     received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS)~     studies and determine whether addition of these drugs results in higher cure rates in~     patients who previously failed therapy. Approximately 100 genotype 1b patients who received~     placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.~   "
124347|NCT01428050|"~     The Whipple operation is a complex surgical procedure involving the removal of the head of~     the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for~     patients who have cancer or some other condition affecting this region of the body. The~     Whipple operation is associated with a significant complication rate. Previous studies have~     shown that in a broad range of surgical procedures, using a reduced amount of intravenous~     fluids along with a special type of fluid called hypertonic saline during and after the~     procedure can lower complication rates associated with the heart and lungs during recovery~     from surgery. The purpose of this study is to determine if using a reduced amount of~     intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous~     fluids) during the Whipple operation and in the immediate period after surgery can reduce~     complications.~   "
124348|NCT01428037|"~     The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal~     misoprostol for cervical ripening and induction of labour.~   "
124354|NCT01427959|"~     Tampere Traumatic head and brain injury study is a prospective study aiming to explore~     neuroradiological, neuropsychological, neurological and biochemical aspects of mild~     traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome~     after mtbi. The study is conducted in Tampere University Hospital's emergency department~     between the 1st of August 2010 and 31st of July 2013.~   "
124355|NCT01427946|"~     Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of~     retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung~     Cancer (NSCLC).~   "
124356|NCT01427933|"~     This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin~     together versus eribulin alone, in participants with locally recurrent or metastatic breast~     cancer.~   "
124357|NCT01427920|"~     This trial was conducted in Asia, Europe and South America. The aim of this trial was to~     confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin~     aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in~     glycosylated haemoglobin (HbA1c).~   "
124358|NCT01427907|"~     The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and~     sevelamer carbonate in maintaining serum phosphorus levels~      This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the~     equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer~     carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim~     of the study is to maintain serum phosphorus level and establish equivalence between COS and~     sevelamer carbonate tablets.~   "
124359|NCT01427894|"~     Study objective is to evaluate the additive effect of maternal singing during skin to skin~     contact (Kangaroo Care) on anxiety reduction both to infants and their mothers.~   "
124360|NCT01427881|"~     This phase II trial studies how well cyclophosphamide works in preventing chronic~     graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients~     with hematological malignancies. Giving chemotherapy and total-body irradiation before~     transplantation helps stop the growth of cancer cells and prevents the patient's immune~     system from rejecting the donor's stem cells. Healthy stem cells from a donor that are~     infused into the patient help the patient's bone marrow make blood cells; red blood cells,~     white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause~     an immune response against the body's normal cells, which is called graft-versus-host~     disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or~     may make chronic GVHD less severe.~   "
124361|NCT01427868|"~     The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites~     of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg)~     tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.~   "
124362|NCT01427855|"~     There is growing epidemiological evidence that consumption of red meat is associated with~     greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods.~     Research from our group has shown that a high saturated fat (SF) diet with a moderate red~     meat content selectively increases intermediate density lipoproteins (IDL) and larger low~     density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller~     LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef~     consumption results in a preferential increase in small and medium LDL particles that are~     strongly related to CVD. To date, no studies have directly compared the lipoprotein effects~     of red meat with that of other food sources of protein in the context of both high and low~     saturated fat intake.~      The overall objective of this project is to test the hypothesis that the effects of SF on~     lipoprotein markers of CVD risk are influenced by sources of dietary protein. The~     investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol~     (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a~     high content of red meat than in diets in which the major proteins are from white meat~     (poultry) or non-meat sources. The investigators propose a clinical trial in which 180~     healthy men and women will be randomized to high SF or low SF diet groups, and within each~     group, consume diets with equivalent amounts of protein from red meat, white meat, and~     non-meat sources for 4 wks each in random order. Specifically, the investigators will test~     whether: (1) With high SF, the red meat diet, compared to the other protein sources, will~     result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density~     lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of~     these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C~     with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat~     the additional increase in small and medium LDL will result in greater increases in plasma~     apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and~     medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a~     key determinant of small LDL production, and that increases in large LDL induced by high SF~     are related to suppression of LDL receptors. The investigators will also assess the effects~     of protein source and saturated fat content on markers of insulin resistance, inflammation~     and endothelial function.~   "
124363|NCT01427842|"~     Current Australian guidelines for vancomycin commonly underdoses individuals particularly in~     the first 48 hours.~      The aim of the trial is to compare two dosing regimens; the current Australian guidelines~     versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of~     developing a new vancomycin dosing strategy that will enable patients to have more~     individualised and therapeutically efficacious treatment.~      The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen~     increases the likelihood of achieving therapeutic trough levels of vancomycin within the~     first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin~     according to the current Antibiotic guidelines.~   "
124364|NCT01427829|"~     The purpose of this study was to examine preliminary effect of Computer-assisted~     Psychosocial Risk Assessment tool (CaPRA) among Afghan refugees visiting medical~     professionals (family physicians or nurse practitioners) at a Community Health Center. The~     investigators examined the tool's acceptability among patients and its impact on patient~     satisfaction and patient intention to visit a psychosocial counselor as a proxy of potential~     to integrate medical and social care.~   "
124365|NCT01427816|"~     To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye~     syndrome.~   "
124366|NCT01427803|"~     An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of~     Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the~     frequency at which consumers exceed the label-defined daily dose, thus putting themselves at~     clinical risk, and 2) the reasons for exceeding the labeled daily dose.~   "
124367|NCT01427777|"~     The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1~     Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male~     subjects aged 9 to 15 years.~   "
124546|NCT01425424|"~     This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest~     elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension)~     or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D.~     This may reduce the chances of developing diabetes or high blood pressure or both later in~     life.~   "
124368|NCT01427764|"~     Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both~     manual and ultrasonic instruments have been used for such decontamination; however,~     establishing a healthy periodontium can result in adverse effects, such as dentin~     hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic~     instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal~     treatment. For this controlled clinical trial of a split mouth design, 14 patients were~     selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on~     the buccal aspect of the teeth. One side (control) was instrumented with hand instruments~     and the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed~     in the baseline and during the follow 4 weeks after treatment, with a periodontal probe~     scratching the root surface and with an air jet. The patient's response was detected by a~     visual analog scale (VAS) of 10 cm.~   "
124369|NCT01427751|"~     This study will evaluate the safety and efficacy of dexamethasone intravitreal implant~     (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein~     occlusion (BRVO).~   "
124370|NCT01427738|"~     The purpose of this study was to see which one of two medicines (topical gentian violet [GV]~     or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC).~     This was measured by whether the study participant still had OC or sores in his/her mouth~     after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the~     treatment of OC were assessed.~   "
124371|NCT01427725|"~     This study aims at collecting the information related to the safety and effectiveness in the~     pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long~     term in order to evaluate the effective and safe use of LipaCreon.~   "
124372|NCT01427712|"~     This study aims at collecting the information related to the safety and effectiveness in the~     pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment~     with LipaCreon in order to evaluate the effective and safe use of LipaCreon.~   "
124373|NCT01427699|"~     The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that~     blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be~     looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by~     blocking inflammation in the pancreas.~   "
124374|NCT01427686|"~     The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in~     term and preterm neonates with arterial hypotension on cerebral and renal oxygenation,~     fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.~      The investigators hypothesize that Dopamine has a stronger effect on blood pressure than~     Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output~     than Dopamine.~   "
124375|NCT01427673|"~     The purpose of this study is to determine if Bipap should assume a standard-of-care role in~     the management of overlap syndrome.~   "
124376|NCT01427660|"~     Two of AHRQ 's consumer-focused guides, Pills for Type 2 Diabetes and Premixed Insulin~     for Type 2 Diabetes could be of great use to underserved ethnic and racial minority adults.~     The presentation of content and delivery mechanisms of these Guides, however, needs to be~     modified to increase their use and impact among these difficult-to-reach populations.~      To achieve this goal, a long-standing collaboration among African American and Latino~     community organizations, health care centers and systems, public health organizations, and~     academics (the REACH Detroit Partnership) is joining with leading experts in the development~     of personally and culturally tailored health decision aids (University of Michigan's Center~     for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in~     Medicine [CBDSM]).~      The investigators will develop and evaluate a computer tailored online diabetes medication~     decision aid that will enable community health workers (CHWs) to provide personalized~     patient education materials to underserved diabetic African American and Latino adults in~     Detroit, Michigan.~   "
124377|NCT01427647|"~     Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative~     outcome following colorectal cancer surgery. The investigators hypothesize that the~     inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared~     to traditional open surgery under general anesthesia.~   "
124378|NCT01427634|"~     The primary aim of the study is to provide proof of concept to demonstrate that patients~     with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a~     randomized trial of palliative care and that such a study is feasible. Secondary aims~     include demonstrating improvement in symptoms (physical and psychological) for intervention~     patients and their caregivers as compared to control patients and caregivers. The~     investigators will also examine differences in utilization of healthcare services,~     mortality, and completion of advance directives between intervention and control patients.~   "
124379|NCT01427621|"~     Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating~     the postoperative course of the patients. The investigators hypothesized that RIPCcom,~     combined intervention of remote ischemic preconditioning and remote ischemic~     postconditioning, would confer beneficial influence on inflammatory response and resultant~     postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart~     surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this~     study was to evaluate the lung-protective effect of combined remote ischemic pre- and~     post-conditioning in patients undergoing complex valvular heart surgery.~   "
124380|NCT01427608|"~     The acute phase of this study will monitor the response to a combination of an atypical~     antipsychotic medication olanzapine with an antidepressant medication sertraline in the~     acute treatment of the disorder. It is predicted that this combination will improve symptoms~     of psychotic depression and be associated metabolic side effects. Factors that moderate~     tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks,~     followed by a period of 8 weeks during which participants will continue to take the same~     medications to stabilize the remission from symptoms of psychotic depression.~      The maintenance phase will be a randomized, double-blind, placebo-controlled study of~     olanzapine for a period of up to 36 weeks to test whether continuing this combination~     decreases the risk of relapse and whether discontinuing the combination leads to improvement~     in metabolic measures. Subjects who complete the acute phase will be asked to consent~     separately to the randomized maintenance phase.~   "
124381|NCT01427595|"~     Many, but not all, girls with high levels of the male hormone testosterone go on to develop~     polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual~     periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of~     difficulty becoming pregnant. The investigators do not understand why some girls with high~     hormones develop PCOS and others do not. In a previous study by our group, some girls with~     high levels of male hormones had abnormalities in the secretion of another hormone, called~     luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had~     normal LH secretion. The girls with the abnormal LH secretion had higher levels of another~     hormone, called insulin, than the girls with normal LH secretion. The investigators will~     test whether metformin, an insulin-sensitizing agent, changes the effects of high male~     hormone levels in adolescent girls, specifically by looking at their LH secretion response~     following metformin treatment.~   "
124382|NCT01427582|"~     The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program~     provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical~     trials with YONDELIS (trabectedin), access to this investigational treatment.~   "
124383|NCT01427569|"~     The purpose of this study is to determine if topical application of a hydrogel that contains~     plant extracts will improve healing of diabetic foot ulcers when compared to treatment with~     a hydrogel alone.~   "
124384|NCT01427556|"~     This study is exploring the relationship between food intake behavior and the~     hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women~     who regularly eat breakfast.~   "
124385|NCT01427543|"~     The goal of this study is to determine whether a culturally congruent, group intervention~     can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.~   "
124386|NCT01427530|"~     This study will be recording and evaluating brain activity from Deep Brain Stimulating (DBS)~     electrodes in patients with Parkinson's disease.~   "
124387|NCT01427517|"~     The investigators are interested in determining if the investigators are able to detect~     changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with~     Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological~     disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC).~     This study will combine information from a medical history, a physical examination and~     disease rating scales with results obtained using MRS brain scans and pharmacokinetic~     studies from blood samples. This research will require 1 visit that will require about 4 to~     5 hours of time. During this study, participants will provide their medical history, be~     examined and undergo a rating scale for about one hour; the brain scan and pharmacokinetic~     studies will require 1.5-2 hours of time; in total the study will take about 4-5 hours.~   "
124388|NCT01427504|"~     The investigators believe that boceprevir's drug concentrations will be reduced when~     administered in combination with etravirine. The investigators believe that etravirine's~     drug concentrations will be increased when administered in combination with boceprevir.~     Additionally, the investigators believe that boceprevir and etravirine are safe when~     administered alone or in combination.~   "
124389|NCT01427491|"~     The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to~     manage bioburden in leg ulcers over a two week study period.~   "
124390|NCT01427478|"~     The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance~     therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2~     every 3 weeks)in squamous cell carcinoma of the head and neck.~   "
124391|NCT01427465|"~     The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse~     prevention strategies that integrate positive youth development messages and health risk~     messages for adolescents in high school settings. A secondary aim is to examine these~     strategies in various combinations as interventions and re-interventions (i.e., boosters)~     for sustaining or enhancing behavior change over time. These strategies are founded upon an~     emerging conceptual framework titled the Behavior-Image Model emanating from findings of our~     recent trials examining multiple behavior health interventions. The long-term objective of~     this project is to reduce alcohol abuse and problems among older high-risk adolescents for~     whom alcohol and drug use disparities exist, yet who are often overlooked in prevention~     research and services.~   "
124392|NCT01427452|"~     Live donor kidney transplantation (LDKT) is important because its outcomes for recipients~     are superior to those of deceased donor transplantation, and it yields significant cost~     savings to the healthcare system overall. Despite efforts over the past few decades to~     enhance understanding of the short- and long-term outcomes of living kidney donation, it is~     clear that investigators have more knowledge in some areas (e.g., surgical and medical~     complications) than in others (e.g., psychological outcomes, financial impact). While the~     transplant community and changes in federal regulations have brought attention to the need~     for more systematic study of living donor outcomes, there remains a paucity of~     scientifically rigorous multisite, prospective outcome studies. The long-term goal of this~     research program is to characterize the short- and long-term surgical, medical, functional,~     psychological, and financial outcomes of living kidney donation. The objective of this study~     is to establish a multisite prospective cohort of living kidney donors, their recipients,~     and a healthy comparison group. This cohort will be used to examine three primary aims: (1)~     to assess donor outcomes (surgical, medical, functional, psychological, financial) over a~     2-year period initially, with the intention of examining these outcomes over a more extended~     time period in subsequent years; (2) to identify the donor, recipient, and center variables~     that are most predictive of donor outcomes; and (3) to identify disparities in donor~     outcomes and their predictors. To accomplish these aims, six kidney transplant programs,~     representing six states (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona)~     and with experience and expertise in caring for living donors and transplant recipients,~     will participate in the study. Donors, their recipients, and healthy controls will complete~     comprehensive assessments at baseline (pre-surgery) and at 1, 6, 12, and 24 months~     post-donation. This study will extend the investigators considerable preliminary work by~     simultaneously examining outcomes that are of importance to donors, recipients, healthcare~     providers, and policymakers. The rationale for this research is that, once these outcomes~     and their predictors are known, investigators can further develop and refine educational~     strategies and informed consent processes for both living donors and their intended~     recipients, as well as provide systematic data to inform policy discussions and clinical~     care practice.~   "
124393|NCT01427439|"~     The purpose of this study is to describe patient functioning and examine associations~     between depressive symptoms and measures of the various roles of functioning.~   "
124394|NCT01427426|"~     Factors Group is a producer of nutritional supplements. This study aims to determine whether~     one of their products improves the energy and sense of well-being in individuals who consume~     it. Interested subjects will complete a 1 week lead-in phase where they will be asked to~     consume a placebo daily to see if they are a good fit for the study. After the lead-in~     phase, subjects will be randomized to take either All Greens or a different placebo for 12~     weeks. The investigators expect All Greens to have better results than the placebo, but~     subjects will not know which supplement they are taking. The primary outcome is a score on a~     questionnaire of well being.~   "
124395|NCT01427413|"~     While the number of assisted reproduction cycles increases worldwide, the introduction of~     actual technological improvements in the ability to quickly and non-invasively identify the~     best embryos for transfer still represents a critical goal for reproductive medicine.~     Indeed, embryo assessment is currently performed through the analysis of morphology and~     cleavage rate. Recent studies have sought to identify a correlation between~     qualitative-quantitative profiles of small molecules of metabolic interest and the outcome~     of embryo transfer. Some of these molecules seem to be best suited for this purpose,~     including glucose, lactate, pyruvate or amino acid levels. Approaches relying on both~     optical and non-optical spectroscopy have been proposed to non-invasively monitor the embryo~     culture media. However, the non-invasive approach only offers an indirect strategy to~     monitor embryos and a turn-around solution to bypass the limits of detection of these~     analytical techniques. In this paper the investigators pave the way for direct assessment of~     embryos through the mass spectrometry-based analysis of blastocoele fluid, which is~     withdrawn from the blastocoele cavity prior to cryostorage of blastocysts. The investigators~     show how it is possible to detect most of the already documented metabolites of interest~     right at the very heart of the blastocyst, without disrupting the workflow of a classic~     laboratory pipeline.~   "
124396|NCT01427400|"~     Breast reconstruction is a common procedure with over 86,000 breast reconstruction~     procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007.~     Of these breast reconstructions, 65% use a tissue expander/implant technique. Although~     satisfactory results can be achieved with a single-stage technique, a two-stage approach is~     considered more reliable, allowing for precise positioning of the inframammary fold and an~     opportune time to perform a capsulotomy to increase the breast skin flap by releasing the~     soft tissue.~      The placement of the tissue expander and implant under the chest muscles is thought to~     minimize the incidence of capsular contracture, expander exposure, and in addition, produce~     acceptable aesthetic results. However, discomfort is often associated with this submuscular~     placement of a tissue expander or implant, specifically during the expansion phase. Patients~     undergoing immediate reconstruction using submuscular implants have been shown to have~     higher analgesic requirements and to have higher pain scores post-operatively, compared to~     non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the~     expander, a longer expansion process, abandonment of reconstruction, and a compromised~     quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at~     the time of surgery may help ease the discomfort that is often associated with this~     procedure.~      The investigators propose a prospective double-blind randomized placebo-controlled trial of~     patients undergoing tissue expander/implant reconstruction. The information gathered from~     this analysis will provide a greater understanding of the effects of Botox in the setting of~     two-stage tissue expander/implant breast reconstruction, with the goal to improve patient~     satisfaction and quality of life.~   "
124397|NCT01427387|"~     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition,~     pre-prandial and postprandial administrations, is compared.~   "
124398|NCT01427374|"~     Individuals with kidney disease are at a higher risk for heart and vascular diseases,~     including heart attacks and strokes, than those with normal kidney function. The purpose of~     this research study is to collect information on the causes, complications and treatment of~     kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in~     routine practice, as well as novel biochemical markers and genetic data will be collected to~     examine relationships between biochemical and genetic markers and cardiovascular risk.~     Information on the health history of incident hemodialysis and peritoneal dialysis patients~     will be captured using structured patient interviews and review of medical records. Blood~     and urine specimens will be collected at the time of dialysis initiation and stored in order~     to perform novel biochemical and genetic assays in the future. The overall goal of the~     CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve~     treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a~     subset of patients enrolled. The goals of the substudy are to examine whether the risks of~     developing common cardiac-related complications (coronary artery calcification [CAC] and~     left ventricular hypertrophy [LVH]) are associated with certain medications taken by~     individuals on dialysis and whether these risks are modified by a genotypic predisposition.~   "
124399|NCT01427361|"~     The primary objective of this study is to investigate the accuracy of the femoral implant~     placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing~     (BHR) surgery postoperatively after total hip resurfacing using the BHR System.~   "
124400|NCT01427348|"~     The purpose of this study is to determine whether the head extension by an assistant~     decreases dental contact between laryngoscope blade and maxillary incisors during direct~     laryngoscopy~   "
124401|NCT01427335|"~     There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous~     calcium is a novel protocol. But still there is lack of evidence of it is real effect in~     prevention of OHSS & the mechanism of its action is still questionable . In the study the~     investigators try to search for the evidence for its effect & the real mechanism for its~     action.~   "
124402|NCT01427322|"~     Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha~     (TGFα), an important growth factor in cancer cell recovery after ionizing irradiation.~   "
124403|NCT01427309|"~     The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard~     dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza~     types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for~     culture-confirmed) to those contained in the respective annual vaccine formulations.~      Primary Objective:~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to laboratory-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined~          influenza-like-illnesses (ILI).~      Secondary Objectives:~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to laboratory-confirmed influenza, caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza, caused by any influenza viral~          types/subtypes, associated with the occurrence of a protocol-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by viral types/subtypes~          antigenically similar to those contained in the respective annual vaccine formulations,~          associated with the occurrence of a modified Centers for Disease Control and Prevention~          (CDC)-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a modified CDC-defined ILI.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by viral types/subtypes~          antigenically similar to those contained in the respective annual vaccine formulations,~          associated with the occurrence of a respiratory illness.~        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly~          adults, with respect to culture-confirmed influenza caused by any influenza viral~          types/subtypes, associated with the occurrence of a respiratory illness.~   "
124404|NCT01427296|"~     The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus~     HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.~   "
124405|NCT01427283|"~     The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release~     tablets (OXN) for the management of opioid-induced constipation (OIC) compared with~     oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain~     and opioid-induced constipation who require around-the-clock opioid therapy.~   "
124406|NCT01427270|"~     The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the~     management of opioid-induced constipation (OIC) compared to oxycodone controlled-release~     tablets (OXY) in subjects with moderate to severe low back pain and OIC who require~     around-the-clock opioid therapy.~   "
124547|NCT01425411|"~     The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has~     beneficial effects on both midwall mechanics and myocardial functions in hypertensive~     patients with Left ventricular hypertrophy.~   "
124407|NCT01427257|"~     Primary objective:~      To compare the pharmacokinetic profile of PB1023 after a single dose administered by~     subcutaneous injection of two formulations (concentrations).~      Secondary objectives:~      To evaluate the safety and tolerability of two formulations of PB1023 Injection administered~     as a subcutaneous injection in adult subjects with T2DM.~      To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of~     formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.~   "
124408|NCT01427244|"~     This is a phase II open-label study of the activity and safety of trastuzumab in patients~     with vulvar Paget's disease with overexpression of HER2 on biopsy.~   "
124409|NCT01427231|"~     The objective of the current study is to determine the acute effect of a glucose drink and a~     sacharose drink compared to a placebo on cognitive performance in elderly with light memory~     complaints. The investigators expect that the sugar containing drinks will improve memory~     and attentional functions. Furthermore, blood glucose response will be measured.~   "
124410|NCT01427218|"~     Existing trials for the patient with coronary heart disease evaluate the interdisciplinary~     team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in~     the inpatient environment. To our knowledge, only other trial has evaluated the addition of~     a pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and~     has found no benefit. However, the investigators believe that since a cardiology based~     pharmacist (pharmacotherapist) in the Veterans Health Administration has physical assessment~     skills, a shorter cycle length between appointments, and the ability to provide medication~     therapy management, the pharmacotherapist should be similarly successful as seen with other~     pharmacist based medication therapy management practices. The investigators will assess~     effectiveness by using the combined endpoint of blood pressure and lipid treatment.~     Additionally the investigators will conduct three substudies to evaluate if the pharmacist~     can improve all cause mortality and cardiovascular morbidity, adherence to~     antihypertensives, and patient satisfaction.~   "
124411|NCT01427205|"~     The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab~     can improve response. The safety of these drugs will also be studied.~      Objectives:~      Primary Objective(s): To assess progression-free survival (PFS) among patients with head and~     neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906~     and compare it with PFS among patients treated with cetuximab plus placebo.~      Secondary Objective(s):~        -  To assess the safety and toxicity of these treatment regimens.~        -  To assess the efficacy of these two treatment regimens in terms of overall survival,~          response rate, and disease control rate~        -  To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms~          of response rate and disease control rate in patients who cross-over from Arm B to~          receive single-agent OSI-906~        -  To explore blood-based and tissue biomarkers~   "
124412|NCT01427192|"~     The purpose of this study is to study the differential short-term effect of nocturnal~     oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on~     symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary~     hypertension and sleep related breathing disorders~        -  Trial with medicinal product~   "
124413|NCT01427179|"~     The purpose of the research is to identify mutations (defects in the genetic blueprint) that~     cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in~     blood vessels that supply the heart.~      Some mutations may be inherited (passed on) from a parent without an apparent blood vessel~     problem while others may develop for the first time in the affected person.~   "
124414|NCT01427166|"~     To date, the scientific literature has yet to provide sufficient evidence regarding the~     pathophysiology of cording. The objective of this protocol is to evaluate the utility of non~     invasive vascular imaging for assessing the pathophysiology of cording in a small study~     cohort of patients who were treated for breast cancer. The hypothesis is that cording may~     have a vascular etiology~   "
124415|NCT01427153|"~     The purpose of this study is to compare an orthopaedic manual physical therapy (OMPT) to~     corticosteroid injection for the management of knee osteoarthritis.~   "
124416|NCT01427140|"~     The purpose of this study is to investigate the metabolic consequences of a moderate weight~     gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the~     effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects~     of weight gain.~   "
124417|NCT01427127|"~     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies~     reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel~     syndrome. The investigators examine the effect of ramosetron used for preventing~     postoperative nausea and vomiting on bowel motility.~   "
124418|NCT01427114|"~     The purpose of this study is to determine how efficient the combination of rituximab,~     cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II~     non-conjunctival ocular adnexal MALT lymphoma (OAML).~   "
124419|NCT01427101|"~     The aim of this study was to compare debulking surgery and cytoreductive surgery in patients~     with Pseudomyxoma Peritonei with respect to efficacy and safety.~   "
124420|NCT01427088|"~     This study aims at investigating the neuroplastic potential and the possible factors~     affecting rehabilitation in chronic schizophrenia patients on stable medication, by~     investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the~     brain, through quantitative stimulus such as rTMS.~   "
124421|NCT01427075|"~     This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for~     treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.~   "
124422|NCT01427062|"~     Falling is a complex and most disabling feature for patients with Parkinson's disease (PD).~     Previous studies suggested that falls in patients with PD are related to postural~     instability characterized by deficits in anticipatory postural adjustment (APA) for postural~     orientation in walking and standing and inadequate postural response to perturbation. The~     present study developed an innovative balance treatment with focus of anticipatory and~     compensatory postural control and examined its effects on enhancing balance and gait~     performance and decreasing fall rate in people with PD.~   "
124548|NCT01425398|"~     High-dose statin therapy around the time of surgery, decreases inflammation in patients~     undergoing cardiac valve surgery, and thereby improves clinical outcomes.~   "
124423|NCT01427049|"~     Hypertension is a major and growing public health concern. Chronic elevation of sympathetic~     nervous system (SNS) activity has been identified as a major contributor to the complex~     pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role~     in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate~     disruption of the nerves connecting the kidneys with the central nervous system, has been~     shown to be an effective means of modulating elevated SNS activity - both by reducing the~     sympathetic modulation of renal function (renin release, sodium excretion and renal blood~     flow) and by removing the renal afferent sympathetic contribution to central blood pressure~     elevation.~      This current study is an observational exploratory study. The main objective of this study~     is to learn more on the effects of RD. We wish to do that by quantifying the effects of RD~     on various biological variables. Those variables are studied in four sets of investigations:~     a radiological set, a laboratorial set, a set of blood pressure measurements and a set of~     investigations in the vascular laboratory. The radiological set consists of imaging of the~     heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial~     set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be~     taken and finally the set of vascular tests contains investigations on pulse wave~     velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define~     future studies, to describe the mode of action and the effects of RD on various organs and~     systems in more detail, and finally to define in more detail which type of hypertensive~     patients is especially likely to benefit of the procedure.~      Hypothesis:~        -  We hypothesize that LV mass will decrease after RD. Because all patients have severe~          hypertension, it is likely that a substantial percentage will have increased LV mass.~        -  We hypothesize that renal perfusion and renal oxygenation increase after RD.~        -  We hypothesize that there will be no complications related to the device or procedure.~        -  We hypothesize that renal denervation has a beneficial effect on insulin resistance~        -  We hypothesize that renal denervation will decrease the blood pressure(office and~          24-hour-measurements)~        -  We hypothesize that RD has a beneficial effect on PWV and HRV.~   "
124424|NCT01427036|"~     Fractures of the trochanter in the elderly have a terrible prognosis both vital and~     functional. It is certainly possible to reduce the medical and economic impact of this~     disease by reducing surgical trauma, by means of minimally invasive osteosynthesis material~     adapted to this approach. This minimally invasive approach should, however, guarantee a~     result at least equal to the standard approach. The goal is to have a technique, easily to~     transmit, using a percutaneous approach, but which may be converted to conventional surgery~     in case of difficulty, and with implants appropriate for trochanteric fractures.~      With this in mind, the dynamic hip screw MISS® (Minimally Invasive Screw System) was~     developed and has already demonstrated its effectiveness in terms of anatomical results. It~     is as effective than the PHS® hip screw design for standard approach. The two implants have~     the same plate and screw and differ only by the system for fixing the screw on the plate to~     allow minimal invasive approach.~   "
124425|NCT01427023|"~     The objective of this study is to obtain female first-catch urine, vaginal swab,~     endocervical swab, and cervical specimens collected in PreservCyt Solution (PreservCyt~     Specimens) for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.~      These specimens will be used to demonstrate assay performance on the PANTHER System is~     comparable to performance on the TIGRIS System.~   "
124426|NCT01427010|"~     Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced~     toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This~     could also be of importance in IMRT for recurrent and second primary head and neck cancers~     in previously irradiated territory.~      This trial investigates the feasibility of continuous adaptive~     18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel)~     intensity-based IMRT in reirradiation of patients with recurrent and second primary head and~     neck cancer.~   "
124427|NCT01426997|"~     To facilitate the development of a personalized approach to the treatment of patients with~     major depression, this study is designed to elaborate the clinical and neurobiological~     phenotype of depressed patients with increased inflammation. The data obtained in this~     proposal will allow the investigators to test the hypothesis that depression and~     inflammation interact to elaborate a relatively discreet phenotype that warrants an~     individualized approach to diagnosis and treatment of patients with depression. Moreover,~     the identification of specific environmental risk factors for inflammation will foster the~     elaboration of preventative strategies for patients at risk.~   "
124428|NCT01426984|"~     The study assesses the effect of Ritalin on working memory,attention,and decision-making~     measures in adults with BPD and compares it to its effect on healthy adults and adults with~     BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators~     hypothesize that Ritalin will result in better performance in all measures.~   "
124429|NCT01426971|"~     Primary Objective:~      - To compare the treatment groups in the reduction of pain score by at least 30 mm on a~     visual pain scale (VAS) at 60 minutes after study medication intake, compared to the~     baseline score (obtained before the study medication intake).~      Secondary Objectives:~        -  To assess the proportion of patients with more than 50% pain relief, according to the~          VAS score at 45 minutes after study medication intake compared to baseline~        -  Determine the following aspects in the timing of study medication intake:~             -  Time to the first perception of pain relief~             -  Time to onset of meaningful pain relief~             -  Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication~               intake, to be evaluated as the difference between the scores on VAS in each period~               and baseline~        -  To assess the pain according to the five items of Headache Relief Rating - HRR (0:~          strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong~          improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to~          the diaries completed by the patients~        -  To check the proportion of the patients requiring the third tablet of study medication~          within 24 hours of starting the study treatment and when it occurred~        -  To check the timing and frequency of rescue medication intake, as well as the~          proportion of patients who used these medications within 24 hours of starting the~          treatment~        -  Safety assessment.~   "
124430|NCT01426958|"~     To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK)~     of afatinib depending on the timepoint of ritonavir administration~   "
124431|NCT01426945|"~     RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial studies protein expression in samples from young patients with~     rhabdomyosarcoma.~   "
124451|NCT01426685|"~     The study will include 1200 patients with type 2 diabetes and angiographically documented~     coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes.~     Extensive traditional and novel risk marker tests are performed for the patients and they~     will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and~     various other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and~     120 non-diabetic patients will undergo exercise training with home monitoring to assess the~     effects of exercise training on risk profiles.~   "
124432|NCT01426932|"~     The alternate binaural bithermal caloric test (ABBT) is a well established examination in~     the evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral~     vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of~     bilateral vestibular involvement when all responses to cold and warm stimuli are reduced,~     and adds to the differentiation of peripheral from central vestibular involvement by~     measuring the fixation-induced inhibition of the caloric response. In spite of these~     benefits, ABBT is the most time-consuming part of the~     electronystagmography/Videonystagmography (ENG/VNG) test battery, and frequently causes~     significant inconvenience to the patient due to the repeated extreme vestibular stimuli.~      The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the~     head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex~     (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation~     of the eyes on the target. Hence, both residual VOR and catch-up saccades act~     synergistically to stabilize gaze. The HIT requires only several minutes and might cause~     minimal discomfort only.~      The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system~     would provide diagnostic information on the side of vestibular involvement matching that of~     the ABBT.~   "
124433|NCT01426919|"~     The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP~     Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow~     Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of~     injury to assist in determining the need for a CT scan of the head.~   "
124434|NCT01426906|"~     A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole~     or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male~     Volunteers.~   "
124435|NCT01426893|"~     The correct use of inhalation devices is an inclusion criterion for all studies comparing~     inhaled treatments. In real life, however, patients may make many errors with their usual~     inhalation device, which may negate the benefits observed in clinical trials. In real life,~     many errors seem to be made, but no wide-scale evaluation has been performed. The correct~     use of inhalation devices is essential to ensure the effectiveness of the treatment. It has~     been recently demonstrated that inhaler misuse is associated with decreased asthma control~     in asthmatics treated with an inhaled corticosteroid. The aim of our observational study was~     to evaluate the inhaler device usage in patients with asthma or chronic obstructive~     pulmonary disease (COPD).~   "
124436|NCT01426880|"~     Study participants with primary breast cancer will receive a standard chemotherapy with an~     anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses~     and duration in concordance to current treatment guidelines. Patients will be receive and~     benefit in addition currently not in the neoadjuvant setting registered medication as~     lapatinib or bevacizumab of which significant increases of cure (pCR) rates have been~     reported in previous phase III studies. Patients randomized to carboplatin will receive in~     addition to the described backbone therapies a potentially active agent which suggested~     synergy of efficacy with chemotherapies as well as targeted agents. Patients might have the~     risk of an increase in toxicities due to the added agents and will have additional burden~     due to investigations required for study participation. However, due to the severity of the~     underlying disease and the high risk of relapse and death due to the stage of disease, this~     increase in toxicity and burden appears less relevant compared to the potential higher~     efficacy and finally cure rate by the incorporated treatments.~   "
124437|NCT01426867|"~     The purpose of this study was to describe the ocular discomfort immediately upon~     instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension,~     Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in~     subjects with open-angle glaucoma and/or ocular hypertension.~   "
124438|NCT01426854|"~     The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is~     superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular~     inflammation and pain associated with cataract surgery in Chinese subjects.~   "
124439|NCT01426841|"~     This study is intended to assess the feasibility of adjusting a radiation plan during its~     course to accommodate for a shrinking tumor target. The investigators hypothesize that an~     adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with~     chest-confined disease will allow for safe delivery of higher doses of chest RT than a~     non-adaptive RT planning approach without subjecting normal critical structures to~     unacceptable doses of radiotherapy.~   "
124440|NCT01426828|"~     This study will enroll myeloma subjects undergoing autotransplantation. The primary~     objective of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated~     autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed~     CD3/CD28 activated autologous lymphocytes. There will be 2 arms in the study, one receiving~     a DLI with non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.~   "
124452|NCT01426672|"~     PURPOSE:~      The purpose of this study is to quantitatively assess the efficacy of monovision correction~     in the treatment of acquired small angle binocular diplopia in adult patients.~      METHOD:~      Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial.~     All had stable deviations of 10 prism diopters or less for over three months. Each received~     monovision spectacles and/ or contact lenses with distance correction in the dominant eye.~     Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and~     standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were~     used to quantify the efficacy of monovision correction for diplopia by measuring the~     functional impact on vision-specific quality of life.~   "
124453|NCT01426659|"~     The preterm children have more difficulty minor neurological developmental than the general~     population even without cerebral palsy. Their oral language difficulties of language and~     writing have been little studied. The investigators propose to study spoken language has 3~     years 1/2 and stimulate or not (depending on randomization) children with phonological~     weaknesses notemment language. The investigators will evaluate stimulation protocol implied~     short and precise language in a re-education say and do in 20 sessions. A new evaluation~     of language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be~     performed at 4 years.~      Early intervention on the basis of precise language before closing the window developmental~     (<5 years) is expected to improve as a result of language and cognitive development of~     preterm infants.~   "
124441|NCT01426815|"~     In this Investigator Initiated study, the investigators want to explore the potential of an~     induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease~     stage (less than 3 months of symptom duration) of patients with predominant peripheral~     spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis~     (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early~     (immature) stage of the disease would result in a significant higher number of patients in~     clinical remission compared to placebo, and that - comparable to the early Rheumatoid~     Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to~     maintain this remission in a number of patients.~      In this placebo-controlled, double blind, randomized study (with open-label phase, starting~     at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of~     peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2~     golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will~     be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated~     with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If~     patients are in 'clinical remission' (clinical remission is defined by the absence of~     arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are~     planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In~     case of clinical relapse, patients will be treated with open-label golimumab 50 mg SC.~     Patients in sustained clinical remission will be observed to assess the possibility of~     maintaining drug-free remission. The study duration will be 48 weeks.~   "
124442|NCT01426802|"~     The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50~     mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.~   "
124443|NCT01426789|"~     This study aims to confirm if patients with a specific biomarker might have a better~     response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will~     be done. The goals of these exploratory studies are to (1) find biomarkers that will~     identify persons with rheumatoid arthritis who will have the best possible response to~     secukinumab and (2) to identify persons who will have fewer side effects in order to~     maximize their benefit from secukinumab.~   "
124444|NCT01426776|"~     Sleep disordered breathing, especially central sleep apnea, is common in patients with~     chronic heart failure. Heart valve replacement could have some effect on central sleep~     apnea. The aim of the study is to investigate effect of heart valve replacement on~     Cheyne-Stokes respiration in patients with rheumatic heart disease.~   "
124445|NCT01426763|"~     The objectives of the study are to:~        1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with~          recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE)~          who previously participated in CINRYZE Study 0624-200 (NCT01095497)~        2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered~          CINRYZE with rHuPH20~        3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of~          CINRYZE with rHuPH20~   "
124446|NCT01426750|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year~     followed during anticancer therapy were included from January 2002 to January 2004. They~     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a~     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was~     observed, tube feeding with the same supplement (TFR) was indicated.~   "
124447|NCT01426737|"~     The purpose of this study is to explore long term glucose variability of a combination~     therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.~      Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.~        -  Trial with medicinal product~   "
124448|NCT01426724|"~     Active forms of vitamin D and its analogs are used to treat elevated parathyroid hormone~     levels and bone disease in chronic kidney disease (CKD). More recent animal and human~     studies suggest that treatment with vitamin D may be associated with reduction of~     inflammation and urinary protein loss as well as reduction the activity of the renin~     angiotensin system (RAS) in addition to its effects on the bone metabolism. The~     investigators of this study have used the new technique of contrast enhanced ultrasound~     (CEU) to measure the flow of blood to the kidney in other human studies. In this study, the~     investigators will investigate if 3 month of treatment with an active form of vitamin D in~     individuals with kidney disease and high parathyroid hormone levels would reduce protein~     loss in the urine. The investigators will also look at the potential changes in blood flow~     to the kidney using CEU, kidney function (GFR), inflammation and activity of RAS in response~     to treatment with active form of vitamin D. Finally, they will examine the association~     between reduction of protein loss in the urine as shown in other studies with any of the~     other factors measured (e.g, change in blood flow or inflammation).~   "
124449|NCT01426711|"~     The care of patients with sepsis and trauma requires the delivery of appropriate definitive~     care in the early stages of the illness. Hospitals with limited resources, those in rural~     and underserved areas of South Carolina, may be unable to consistently provide optimal care~     to these patients. In addition, the shortage of specialists nationally makes it more~     difficult for these hospitals to recruit and retain the specialists needed. Patients in~     these areas continue to pay the rural penalty of poorer outcomes. This study provides~     specialists' level care through telemedicine consults to rural emergency departments in~     rural areas of SC to improve outcomes for these patients.~      The CREST study is a project that specifically addresses the need to bring health care to~     rural communities in SC, as well as evaluates methods and tests technology to implement this~     care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural~     community hospitals to provide rural community physicians care from specialists for trauma~     and sepsis, which are both high acuity, difficult to treat conditions.~      CREST is a multi-site trial of telemedicine services to meet rural patients' and providers'~     need for expert evaluation and management of sepsis and trauma. The specific aims of CREST~     are:~        1. To test the hypothesis that a telemedicine program including education and clinical~          consultation between a tertiary care academic medical center and rural, local hospitals~          will significantly improve key treatment decisions and outcome measures in sepsis and~          trauma.~        2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma~          and sepsis patients exposed to telemedicine intervention and those without the~          intervention matched on propensity scores are not due to unmeasured confounders.~      CREST seeks new solutions to rural health disparities, to advance technology, create and~     retain jobs and address important research opportunities by combining implementation of a~     novel, trans disciplinary clinical program with rigorous, mixed methods scientific~     evaluation including clinical, process, and economic outcome measures. The impact on both~     science and quality healthcare outcomes is broad and CREST has far reaching implications for~     addressing rural health disparities for acute, life-threatening illnesses.~   "
124454|NCT01426646|"~     Although there has been some progress in chemotherapy for metastatic gastric cancer, no~     standard regimen of adjuvant chemotherapy is available, and many clinical trials have~     produced contradictory results. The majority of randomized clinical trials studying adjuvant~     chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used~     ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still~     needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric~     cancer patients who underwent curative resection with extended lymph-node dissection (D2),~     may be valid in countries where D2 surgery is considered the standard of care. S-1 improved~     the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall~     survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%,~     respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based~     on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial,~     further investigation is needed for more effective postoperative treatment of patients with~     stage IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and~     safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively~     resected gastric adenocarcinoma.~   "
124455|NCT01426633|"~     L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas~     and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment~     armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure~     with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas~     (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been~     described for the use of gemcitabine and especially the combination of gemcitabine and~     docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination~     of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and~     refractory peripheral oedema are the most common severe adverse events. The aim of the~     present phase I study will be to examine safety data of this promising treatment combination~     of gemcitabine and trabectedin in L-sarcomas.~   "
124456|NCT01426620|"~     This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder,~     synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The~     proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy~     will have a significant, positive effect in the response rate and overall survival.~   "
124457|NCT01426607|"~     This is a randomized controlled study evaluating the impact of 2 months of oral appliance~     therapy on endothelial function in patients with severe obstructive sleep apnea syndrome~     intolerant to continuous positive airway pressure (CPAP) therapy.~   "
124458|NCT01426594|"~     This is a Phase 4, observational, open study in patients who their doctor has prescribe~     METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by~     the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an~     evaluation of baseline followed by information gathered from the assessment visits at week 4~     and week 8.~   "
124459|NCT01426581|"~     The purpose of this study is to evaluate the relative effectiveness of two different ways to~     teach subjects while hospitalized how to use respiratory inhalers and to follow-up after~     discharge home from the hospital to determine durability of the education.~      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then~     repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief~     Intervention (BI) education only consists of providing the patient with verbal and written~     instruction.~      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's~     ability to retain instructions on respiratory inhaler technique. The investigators will test~     this hypothesis separately for the MDI and Diskus® devices after discharge.~   "
124460|NCT01426568|"~     The purpose of this study is to determine whether multi-convergent therapy is helpful to~     patients with inflammatory bowel disease who have functional abdominal symptoms or high~     perceived levels of psychological stress.~   "
124461|NCT01426555|"~     This is a research study to determine the effects of functional electrical stimulation (FES)~     rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if~     zoledronic acid treatment will increase bone mineral density in persons with chronic spinal~     cord injury (SCI) who received it. The investigators also want to find out if zoledronic~     acid is safe for persons with SCI to take without causing too many side effects.~   "
124462|NCT01426542|"~     Newborn babies with congenital heart disease often require surgery in the first month of~     life. The risks of brain damage from congenital heart disease and from the various~     corrective surgeries are high because of poor levels of oxygen reaching the brain.~     Topiramate is an anti-convulsant medication that protects brain cells from damage due to low~     amounts of oxygen in animal studies. The investigators hypothesize that giving topiramate to~     babies with congenital heart disease before and after surgery will decrease the amount of~     brain damage caused by the heart disease and/or the surgery to correct the heart disease.~   "
124463|NCT01426529|"~     Caveolin-1 and Vascular Dysfunction~      Thank you for your interest in the investigators Blood Pressure Research Study. The National~     Institutes of Health are sponsoring us to investigate why patients develop high blood~     pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two~     parts of the investigators research program. The first part is a screening visit. At this~     visit you will be given a brief physical exam and will be asked questions concerning your~     medical history. During the same visit you will have your blood drawn for routine screening~     and genetic testing. You will also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, the investigators will perform physiological~     tests after you are placed on a low salt diet and again after you are placed on a higher~     salt diet. If you are on blood pressure medication, it may be necessary to discontinue~     taking your present medication for up to three months before beginning the study. Patients~     discontinuing their current blood pressure medication may be placed on a different blood~     pressure medication during this 'washout' period if necessary to maintain blood pressure at~     pre-study levels.~      Once your blood pressure medications are discontinued, you will be closely monitored. If you~     do not own a home blood pressure monitor, the investigators will provide one for you to use~     during the study so that you can keep a daily record of your blood pressure readings. The~     investigators will ask you to call us every three days to report your blood pressure~     readings. After you have stopped taking your medication, dieticians at the hospital will~     make you low salt meals to eat at home for about seven days. On the last day of the low salt~     diet, you will be asked to begin a 24-hour urine collection that you will bring with you~     when you are admitted to the hospital that evening. That morning, you will be required to~     come to the Center for Clinical Investigations (CCI) at Brigham and Women's Hospital for a~     one-hour test to check if your body is in the correct salt balance.~      You will return that evening to the CCI where you will be admitted for your study that will~     occur the next morning. On the morning of your low salt study, the investigators will~     collect some blood samples. The investigators will also take ultrasound pictures of your~     heart to see how salt and hormones affect the way your heart and blood vessels functions.~     These tests will last approximately 5 hours and you will be discharged around 2:00 PM. For~     the next 5-7 days, you will be placed on a high salt diet. During this diet period, you will~     eat all your own food, but the investigators will give you some supplements to add to your~     meals. After 5-7 days on your high salt diet, on the morning of your second admission to the~     hospital, you will be asked to begin a final 24-hour urine collection. That morning, you~     will again be required to come to the CCI for a blood test, and you will return later that~     evening to the inpatient CCI where you will be admitted for your final overnight study. The~     same study that was done for the low salt diet will be repeated for the high salt study. You~     will be discharged at around 2:00 p.m. These studies will help to determine if you are~     salt-sensitive. In addition, the investigators hope to learn more about the hormones that~     regulate your blood pressure and the genes responsible for regulating those hormones.~      You will have the option to spend a second night in the CCI after each diet phase in order~     to participate in an optional study of the blood vessels in the arm. This study also uses an~     ultrasound machine. It will last about 2 hours in the morning.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. The investigators can also provide clinically~     relevant information to you.~   "
124476|NCT01426347|"~     The purpose of this study is to investigate the effect of vitamin D repletion on disease~     activity and disability in patients with rheumatoid arthritis.~      The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D~     deficiency have greater disease activity and disability, compared to RA patients with normal~     vitamin D levels. The investigators also hypothesize that vitamin D treatment in these~     deficient patients will result in a decrease in RA disease activity and disability.~   "
124477|NCT01426334|"~     This phase I trial studies the side effects and the best way to give dasatinib and~     cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or~     intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by~     making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine~     may be an effective treatment for CML.~   "
124562|NCT01425216|"~     Treatment of keloid disorder is an area of unmet medical need. Current treatments for keloid~     partially address small and localized keloids, yet there are no wholly satisfactory or~     effective treatments for patients with extensive keloids. Such patients may benefit from~     effective systemic treatments.~      Sorafenib has the potential to regulate the three known dysregulated biological pathways in~     keloid tissue.~   "
124464|NCT01426516|"~     One-third or more of individuals treated for major depressive disorder (MDD) do not~     experience remission of symptoms despite at least two adequate antidepressant trials. Such~     treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs~     of MDD, in terms of health care costs, functional impairment, and diminished quality of~     life.~      The promise of personalized medicine for individuals at high risk for TRD is apparent. If~     these individuals could be recognized early in their disease course, they could be triaged~     to more intensive or targeted interventions to improve their likelihood of remission. With~     the proliferation of treatment options in MDD, at present individuals can spend months or~     years in and out of treatment before receiving these next-step treatments.~      At present, no clinical or biomarker-based tool has been shown to assist in matching~     patients with treatments most likely to be effective for them. The Genecept Assay offers the~     possibility of Personalized Medicine in psychiatry. Clinicians may find this additional~     genetic information can lead to optimized treatment plans for individual patients. Before~     such an assay can be widely applied clinically, it is necessary to demonstrate that this~     tool usefully impacts treatment outcomes.~      This study will examine the potential impact of the assay in terms of depression severity at~     3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate~     of its potential to change clinician behavior and improve patient quality of life. Further~     measures will also allow for refinement of the assay to maximize patient and clinician~     satisfaction, and estimate the potential savings associated with deployment of this assay in~     real-world clinical settings.~   "
124465|NCT01426490|"~     Vitamin B-6, folate and homocysteine may play a critical role in the colorectal cancer~     progression. This is a 4-y study and the specific aims are: 1) to compare vitamin B-6,~     folate and homocysteine status, oxidative stress, antioxidant activities and DNA methylation~     between subjects with colorectal polyps and colorectal cancer; 2) to study the effects of~     vitamin B-6, folate and homocysteine status on oxidative stress, antioxidant activities and~     DNA methylation in colorectal cancer patients; 3) to evaluate whether folic acid and/or~     pyridoxine supplementation had a beneficial effect on oxidative stress, antioxidant~     activities and DNA methylation in patients with colorectal; 4) to compare vitamin B-6,~     folate and homocysteine status, oxidative stress, antioxidant activities and DNA methylation~     between colorectal cancer patients and age-, sex-matched healthy subjects; 5) to evaluate~     the effect of vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant~     activities and DNA methylation on the risk of colorectal cancer (odds ratio); 6) to follow~     the effects of vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant~     activities and DNA methylation on the occurrence of colorectal cancer; 7) to follow the~     effects of pyridoxine and/or folic acid supplementation on the occurrence of colorectal~     cancer.~      This protocol is designed as a hospital-based cross-sectional, case-control, double blinded~     randomized placebo-controlled intervention and follow-up trial. Three hundred colorectal~     cancer patients and 300 age-, sex-matched controls who meet the inclusion criteria will be~     recruited from Taichung General Veterans Hospital. If cancer patients' plasma pyridoxal~     5'-phosphate (PLP) level less than 30 nmol/L will be asked to participate the intervention~     study and will be blinded and randomly assigned to either the 1) control (vitamin C, 100~     mg/d); 2) 50 mg vitamin B-6; 3) 400 microgram/d folic acid; or 4) vitamin B-6 (50 mg/d) plus~     folic acid (400 microgram/d) for 1 year. Data on demography, anthropometry, medical history,~     food frequency questionnaire and 24-h diet recall will be collected. Cancer patients will~     have fasting blood drawn before surgery or receiving chemotherapy. Additionally, fasting~     blood samples will be obtained at month 0, 3, 6, 9 and 12 during intervention period and at~     month 6, 12, 18, 24, 30, 36, 42 and 48 during follow-up. Hematological, plasma and~     erythrocyte PLP, plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum~     vitamin B-12, homocysteine, SAM, SAH, lipid peroxidation indicators (TBARS, oxidized LDL),~     glutathione, antioxidant enzymatic activities and DNA methylation and MTHFR 677C>T~     polymorphism will be measured.~   "
124466|NCT01426477|"~     The main study objective is to determine the frequency of hernia recurrence following use of~     Veritas Collagen Matrix.~   "
124467|NCT01426464|"~     The purpose of this study is to evaluate the safety and effectiveness in lowering~     intraocular pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost~     that is applied to the outside of one eyelid.~   "
124468|NCT01426451|"~     The purpose of this study is to determine whether a drama workshop program for immigrant and~     refugee youth is effective in reducing impairment in high school students presenting~     learning difficulties.~   "
124469|NCT01426438|"~     This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C~     is a type of good cholesterol. People with low HDL-C have a higher risk of heart disease~     and may have problems with how their blood vessels relax. The endothelium is the inner~     lining of all blood vessels, such as arteries and veins. When the endothelium is not working~     properly, the blood vessels have trouble expanding properly, which contributes to the~     development of heart and blood vessel disease.~      The main purpose of this study is to see if taking either extended-release niacin or~     fenofibrate for 24 weeks will help blood vessels work better by improving endothelial~     function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This~     study will also help determine how safe extended-release niacin and fenofibrate are.~      The analysis is an as-treated analysis of participants who completed study treatment and had~     a week 24 BART scan. Safety analyses include all participants~   "
124470|NCT01426425|"~     ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a~     prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational~     clinical study. The purpose of this clinical study is to demonstrate the safety and~     effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the~     conducting tissues of the heart in the treatment of patients with atrioventricular nodal~     reentrant tachycardia (AVNRT) using an endocardial approach.~   "
124471|NCT01426412|"~     This is a study in otherwise healthy Japanese and non-Japanese participants with elevated~     low density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety~     and tolerability of the drug, how the body handles the drug, and the drug's effect on the~     body will be evaluated. Participants will remain in the study for approximately up to 6~     months.~   "
124472|NCT01426399|"~     The objective of the study was to investigate the drug-drug interaction between LC15-0444~     and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in~     healthy male subjets after oral administration concomitantly and each alone.~   "
124473|NCT01426386|"~     This trial investigates the effects of several doses of FE 999049 in women undergoing~     IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.~   "
124474|NCT01426373|"~     To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area~     (below the chin).~   "
124475|NCT01426360|"~     The objective of the present study was to compare the effects of a commercially available~     dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base,~     versus a control dentifrice, containing exactly the same ingredients apart from strontium~     chloride and potassium nitrate, on the instant and lasting relief of DH.~   "
124606|NCT01424644|"~     The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline,~     Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly~     with MenACWY are comparable to responses elicited by these vaccines when given alone.~   "
124478|NCT01426321|"~     For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a~     major improvement. The treatment improves symptoms and prolongs life in selected patients~     with heart failure. However, with the current selection criteria and methods for implanting~     the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.~      New imaging techniques, including advanced ultrasound and computed tomography, in~     combination with new versatile multi-pole electrodes, have made an individually tailored~     therapy possible. Using these techniques in combination, the study will investigate the~     effect of individually based optimal placement of the pacemaker electrodes vs. standard~     care. The optimal LV electrode position is defined as pacing a viable segment with the~     latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on~     cardiac CT. The hypothesis is that this will increase the number of positive responders from~     65% to 85%.~   "
124479|NCT01426308|"~     The study will determine the performance of the Infinium HD Test.~        -  The primary objective of the study is to assess the performance of the Infinium HD Test~          using banked DNA samples extracted from whole blood patient samples derived from the~          intended use population.~        -  The secondary objective of the study is to determine the background number of~          chromosomal abnormalities per person in the general population based on the resolution~          of the Infinium HD Test.~   "
124480|NCT01426295|"~     The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in~     addition to standard oral care (strategy A) is cost-effective in the prevention and~     treatment of severe mucositis in adult patients with auto or allograft packaging without ICT~     versus mouthwashes standard bicarbonates with an antiseptic (strategy B).~   "
124481|NCT01426282|"~     The purpose of this study is to evaluate the effects of health education given by nurse on~     out-patient compliance in cardiovascular diseases prevention and treatment.~   "
124482|NCT01426269|"~     The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea~     during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen~     of Oracea® and MetroGel® 1%.~   "
124483|NCT01426256|"~     The purpose of this study is determine if high-dose vitamin D supplementation improves~     clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who~     are admitted to the hospital with an acute lung infection.~   "
124484|NCT01426243|"~     Main objective :~      To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever~     Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative~     individuals who had not been given YFV before.~      Secondary objectives :~        -  To develop and assess ELISPOT technology for yellow fever and to measure the response~          within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects~          and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy~          (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6~          months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in~          ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test~          (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia~          and (5) diversity of viral quasi-species.~        -  To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and~          viral load.~   "
124485|NCT01426230|"~     Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical~     practice~   "
124486|NCT01426204|"~     This is a Phase 4, descriptive, observational, open, prospective study of patients who their~     doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor.~     The planned observation time is 48 weeks and 24 weeks of follow-up.~      Each investigator participating in this registry will employ his or her discretion and~     standard clinical practice to determine when to see the patient in the clinic, how to manage~     the patient's drug regimen, and how best to monitor the patient's response and tolerance to~     therapy.~   "
124487|NCT01426191|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory~     and urinary tract acute bacterial infection under the widely used in clinical conditions.~   "
124488|NCT01426178|"~     Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony~     reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support~     (PSV) mode.~      The purpose of the protocol is to compare asynchrony rate between periods of pressure~     support and periods of NAVA.~   "
124489|NCT01426165|"~     Hypomagnesemia (low magnesium) is an electrolyte imbalance commonly found in up to 65% of~     critically ill patients. Possible consequences of hypomagnesemia include neuromuscular and~     neurologic dysfunction, heart arrhythmias, and alterations in other electrolytes. Data has~     shown that critically ill patients with hypomagnesemia have a significantly higher mortality~     rate than patients with a normal magnesium level. The most simple and commonly used test to~     diagnose hypomagnesemia is a serum magnesium level. Based on the magnesium level and~     symptoms of hypomagnesemia, patients may be replaced with either oral or intravenous (IV)~     magnesium. When replacing magnesium via the IV route, approximately half of the dose is~     retained by the body while the remainder is excreted in the urine. The low retention rate is~     due to the slow uptake of magnesium by cells and decreased magnesium reabsorption by the~     kidneys in response to the delivery of a large concentration of magnesium. The purpose of~     this study is to determine whether an eight hour compared to a four hour infusion of IV~     magnesium sulfate results in a greater retention of the magnesium dose.~   "
124490|NCT01426152|"~     Progesterone levels measured in blood/serum of patients on the day of ovulation induction~     following controlled ovarian stimulation for in vitro fertilization may be associated with~     pregnancy outcome. The hypothesis is that higher progesterone levels are associated with~     lower implantation rates due to changes in the endometrial receptivity.~   "
124491|NCT01426139|"~     The objective of this clinical investigation is to assess the safety and clinical~     performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo~     coronary artery lesions.~   "
124607|NCT01424631|"~     This is a randomized prospective study comparing single incision versus conventional~     laparoscopic appendectomy for management of acute appendicitis.~   "
124492|NCT01426126|"~     Taxane-based chemotherapy is currently one of the most commonly used regimen for salvage~     chemotherapy in advanced urothelial carcinoma. In previously untreated patients,~     single-agent paclitaxel, administered in a 24-hour infusion, produced an overall response~     rate of 42%, and single-agent docetaxel as a first-line therapy produced response rates of~     31% and 45% in 11 patients with impaired renal function. Of the two taxanes, paclitaxel has~     been studied more extensively.~      Intravenous administration of paclitaxel requires the use of solubilizing agents such as~     Cremophor EL (CrEL) due to its hydrophobicity. CrEL often contributes to hypersensitivity~     reactions including hypotension or dyspnea with bronchospasm, some of which are major and~     potentially life-threatening. Minor allergic reactions such as transient rashes and flushing~     also may occur. Despite pretreatment with corticosteroids and histamine antagonists, minor~     reactions still occur in 10-44% of all patients, with 1-3% of patients experiencing~     potentially fatal reactions. CrEL may also act as a potential cofactor for the development~     of peripheral neuropathy. In addition, special infusion sets must be used clinically when~     administering CrEL-based paclitaxel.~      Genexol-PM (Samyang Co., Seoul, Korea), a form of paclitaxel formulated with sterile,~     lyophilized polymeric micells that allow intravenous delivery of paclitaxel without CrEL.~     The polymeric micelle formulation is composed of hundreds of low molecular weight, nontoxic,~     and biodegradable amphiphilic diblock copolymers which include monomethoxy poly(ethylene~     glycol)-block-poly(D,L-lactide), and has a great potential in terms of water solubility, in~     vivo stability, and the nanoscopic size (a diameter of 20-50 nm) of the micellar structure.~      A phase I study established that Genexol-PM administered at 390 mg/m2 intravenously for 3 h~     every 3 weeks was the maximum tolerable dose (MTD) in humans. Dose-limiting toxicities were~     neuropathy, myalgia, and neutropenia. No hypersensitivity reactions were observed in any~     patients despite the absence of antiallergic premedication. The recommended dosage for phase~     II studies was 300 mg/m2.~      Based on the promising results of taxane-based chemotherapy and the absence of standard~     second-line chemotherapy regimen for advanced urothelial cancer, the investigators designed~     phase II study to explore the efficacy and safety of Genexol-PM in advanced urothelial~     patients, who previously treated with gemcitabine plus platinum as adjuvant chemotherapy or~     1st line therapy for metastatic diseases.~   "
124493|NCT01426113|"~     The purpose of this study is to assess the safety and efficacy of a new formulation of~     bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of~     paediatric patients with glaucoma.~   "
124494|NCT01426100|"~     The aim of the present study is to evaluate the efficacy and safety of two dose combination~     of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy~     (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.~   "
124495|NCT01426087|"~     The main complications of cirrhosis are ascites, esophageal varices and hepatic~     encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the~     most common complication is ascites. Somatostatin is used to treat esophageal for a long~     time, otherwise it could aslo prevent ascites. In the study, the investigators explore the~     effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with~     esophageal gastric varices.~   "
124496|NCT01426074|"~     This study will determine the following: the response rate (including pathological CR rate),~     TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX~     bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in~     Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated~     with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis~     (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and~     its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by~     tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to~     changes in tumor blood flow.~   "
124497|NCT01426061|"~     There is a lack of scientific evidence that homeopathy and reflexology is effective~     treatment of asthma. Systematic reviews have found that many clinical trials testing~     homeopathy and reflexology have major flaws, such as small number of participants, lack of~     control groups or inadequate allocation concealment.~      The aim of the present study was to assess the effect of reflexology and individualised~     homeopathy as an adjuvant treatment in asthma. In order to address this issue, the~     investigators conducted an investigator-blinded, randomized, controlled parallel group~     study.~   "
124498|NCT01426048|"~     A follow-up study of 191 patients operated on with the TVT procedure between January 1998~     and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital.~     After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome~     was evaluated with condition-specific and general quality of life and health questionnaires.~     Objective outcome was evaluated with gynaecological examination and a supine stress test.~     Objective cure was defined as a negative stress test and no need for a reoperation for SUI~     and subjective cure.~   "
124499|NCT01426035|"~     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream~     in the treatment of superficial varicose veins~   "
124500|NCT01426022|"~     Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after~     a meal. Postprandial mood can be measured by subjective responses. Physiological responses~     may play an important role in the generation of postprandial mood. However, the relationship~     between subjective and physiological responses after a meal is not clear yet. To investigate~     this relationship, moderate alcohol consumption will be used as a mood modulator, because of~     its well-studied effects on mood. Postprandial mood depends on the current mood state.~     Therefore the investigators will manipulate the current mood state by changing the ambiance~     to measure the influence of moderate alcohol consumption with a meal on postprandial mood in~     a pleasant or unpleasant ambiance.~      Objective: To determine whether moderate alcohol consumption with a meal in different~     ambiances affects postprandial mood, evaluated by subjective and physiological parameters.~      Study design: Randomized, placebo-controlled, single-blind, cross-over trial~      Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y),~     taking oral contraceptives.~      Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white~     wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant~     meal ambiance.~      Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different~     ambiances changes the response of subjective and physiological parameters of mood.~        -  Ho: there is no effect of alcohol consumption and ambiance on mood~        -  H1: there is an effect of alcohol consumption and ambiance on mood~   "
124501|NCT01426009|"~     The purpose of this study is to determine steady-state efficacy and dose response profile~     and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day~     dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and~     two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD).~   "
125075|NCT01418508|"~     The purpose of this study is to determine whether low protein diet and very low protein diet~     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney~     disease (CKD , stage 3b and 4).~   "
124502|NCT01425996|"~     Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in~     patient who is not suitable for transarterial chemoembolization (TACE) and other local~     therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells.~     Several previous studies have showed that local R/T is tolerable and can induce a~     substantial tumor response in HCC management. In addition, the safety, toxicity and~     preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal~     malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant~     Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.~   "
124503|NCT01425983|"~     Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic~     dysfunction, as well as alterations of the autonomic nervous system and the~     hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between~     inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia,~     neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms,~     sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary~     intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT,~     serotonin) increases sensitivity to stress.~      It is therefore the investigators hypothesis that daily oral administration of an amino acid~     mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease~     neurovegetative disorders will target these neuroendocrine and metabolic alterations in~     adults with psychosocial stress. The principal endpoints will be a decrease in points in the~     psychological-neurological questionnaire (PNF).~   "
124504|NCT01425970|"~     Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189~     and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment~      Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189~     with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin~   "
124505|NCT01425957|"~     THE STUDY WILL BE A TWO-PART RESEARCH~      PART A and PART A extended:~        1. To implement a common MRI acquisition protocol in multiple centers across Europe~          (Pharma-COG partners).~        2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare~          and minimize test-retest variability across the MR sites of WP5 for all the~          quantitative metrics that will be later assessed on patients.~      PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and~     neurophysiological data in Mild Cognitive Impairment patient, we aim to:~        1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)~          which is more sensitive than the changes observed in the loss of hippocampal volume~          (primary endpoint) and correlate with the neuropsychological progression and conversion~          (clinical secondary endpoints).~        2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)~          at baseline which is more predictive of the loss of hippocampal volume (primary~          endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI~          patients.~        3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe~   "
124506|NCT01425944|"~     This study has three aims that hope to expand the knowledge on the cause of Sturge-Weber~     Syndrome (SWS) and improve clinical care of Sturge-Weber Syndrome patients.~   "
124507|NCT01425931|"~     O2C is a diagnostic device for non-invasive determination of oxygen supply in~     microcirculation of blood perfused tissues. The optical sensor is easy to handle and~     guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as~     in research. The examinations are without any strain for your patient.~      Determines by use of a glass fibre probe:~      Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of~     Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen~     supply of organs and tissue.~      With it is possible to measure locally the amount of oxygen which is transported into the~     region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is~     monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical~     sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and~     subsequently to organ failure, now can be detected in an early state by use of the new~     sensor system.~      One of these new developed sensors are used to place in rectal position during~     extracorporeal circulation to determine the microcirculation.~   "
124508|NCT01425918|"~     Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD)~     social deficits and studying the efficacy of this intervention, the investigators hope to~     provide a means for children with ASD to more effectively and efficiently process social~     information and enable them to more successfully engage in social interactions. Children~     between the ages of 24 and 36 months and their families may join.~   "
124509|NCT01425905|"~     Background:~      Type 2 diabetes is a chronic disease that puts individuals at risk for serious health~     problems like heart disease, kidney failure, vision problems, and stroke. A major way that~     type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin~     (an important hormone in the body to keep blood sugar normal) isn t working as well as it~     should, which can lead to problems with high blood sugar. Insulin resistance has been linked~     to mood problems, stress, and depression, especially in women. To determine if group~     programs can help reduce the risk for type 2 diabetes, researchers want to look at teenage~     girls who are at risk for developing the disease.~      Objectives:~      To test whether a group program designed to improve mood also can help improve insulin~     resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a~     group program that teaches healthy living skills is just as helpful.~      Eligibility:~      Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.~      Design:~        -  Participants will have two screening visits to find out if they are eligible to take~          part in the study. The first visit takes about 3 hours and will involve a physical~          exam, medical history, questionnaires and an interview about mood problems and possible~          depression. The second visit takes about 6 hours and will involve a full body scan to~          measure muscle and fat, blood draws and a glucose test to determine insulin resistance,~          questionnaires about general well-being and eating habits, eating meals and snacks, and~          an exercise test.~        -  Participants will join one of two group programs at the National Institutes of Health.~          One group focuses on learning skills to help with bad moods and stress. The other group~          covers topics that are important for teens to lead a healthy life. The groups will meet~          for 1 hour once a week for 6 weeks during after-school hours.~        -  At the end of the groups, participants will have three follow-up visits. The first~          visit will be 6 weeks later, the second will be 6 months after the start of the group~          program, and the third will be 1 year after the start of the group program. Each visit~          will take about 6 hours. These visits are similar to the second screening visit before~          the groups.~        -  Some participants will have extra tests to study stress at the second screening visit~          and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples~          of DNA, saliva to measure stress hormones, and they will take part in a brief stress~          test.~      For more information, visit the study website at: http://mir.nichd.nih.gov or contact the~     research coordinators for the study at 301-594-3198.~   "
124608|NCT01424618|"~     This study compares two different methods to prepare the uterine lining of recipients for~     implantation in cycles using donor eggs. The study method requires less time than the~     standard method.~      It is hypothesized that both methods would be suitable for use in egg donor cycles.~   "
124510|NCT01425892|"~     Background:~      -Sjogren s syndrome is a disease that affects about 1-4 million Americans. It is more common~     in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes~     and dry mouth. The cause of Sjogren s syndrome is unknown, but inflammation plays an~     important role. The purpose of this study is to learn more about Sjogren s syndrome.~      Objectives:~      -To better understand how Sjogren s syndrome begins and how it affects patients so that we~     can develop better ways to treat them.~      Eligibility:~        -  Participants must be 16 years of age or older.~        -  They must have a diagnosis of Sjogren s syndrome or have at least two symptoms of~          Sjogren s syndrome.~      Design:~        -  People taking part in the study will come to the NIH Clinical Center for at least three~          visits.~        -  During these visits, participants will have a medical history and physical exam. They~          will have oral and dental assessments, and saliva collection. Lab tests (blood and~          urine) and dry eye exams will be done. Participants will answer questionnaires and have~          salivary scintigraphy (adults only unless required for diagnosis).~        -  Other optional tests may also be done. Participants may have to come in for additional~          visits if they have these optional tests or if their disease changes.~        -  The only treatment provided as part of this study is for medical emergencies or~          complications that occur while you are at NIH for evaluation.~   "
124511|NCT01425879|"~     This phase II trial is studying how well MD2206 works in treating patients with advanced~     refractory biliary cancer that cannot be removed by surgery.~   "
124512|NCT01425866|"~     Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical~     trials have clearly demonstrated that a better control of blood glucose level and of other~     risk factors is efficient in preventing or retarding the complications of the disease. On~     Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high~     level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured~     group self-management education maintained at the community level for 2 years in patients~     with insufficiently controlled type 2 diabetes has better metabolic results (as attested by~     improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months)~     self-management program, based on the same theoretical basis and framework (learning nests~     empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus~     with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to~     2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long~     sessions depending on individual assessment), or a long term program including the same~     initial program as 1st arm, but with group self management education sessions, maintained~     for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative~     additional specific thematic sessions being delivered if needed). Medical visits will be~     held quarterly for the recording of outcome measures (HbA1c, blood pressure,~     anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose,~     lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise~     (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and~     depression scales, and social support.~   "
124513|NCT01425853|"~     The purpose of this study is to determine whether the combination of Chondroitin sulfate~     (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the~     treatment of patients with moderate to severe knee osteoarthritis (OA).~   "
124514|NCT01425840|"~     This blinded cross-over study aimed to evaluate the efficacy of topical~     liposome-encapsulated lidocaine on oral mucosa.~   "
124515|NCT01425827|"~     Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis~     worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options~     have had limited symptomatic effect and are associated with significant side effects.~     Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to~     have, besides its antidepressant properties, a centrally acting analgesic effect.~      The aim of the present study was to investigate the efficacy of duloxetine in reducing pain~     in older adults with knee OA.~      288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary~     knee OA attending the outpatient clinic of our institution were enrolled in this study. All~     patients underwent a physical examination and where questioned about the number of flares.~     Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid~     obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of~     duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The~     primary outcome measure was pain reduction. Secondary outcome measures included improvements~     in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and~     Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported~     physical function as measured with the Western Ontario and McMaster Universities~     Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression~     Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were~     recorded. Safety and tolerability were also assessed. Data was collected at baseline and at~     monthly intervals for 4 months. All staff involved in data collection was blinded to the~     treatment assignment groups.~   "
124516|NCT01425814|"~     The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single~     doses of inhaled LAS100977 in COPD patients.~   "
124517|NCT01425801|"~     The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled~     LAS100977 QD in patients with persistent asthma.~   "
124518|NCT01425788|"~     The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used~     with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current~     practice.~   "
124538|NCT01425528|"~     The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of~     tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH)~     deficiency and to asses the potential impact of oral Kuvan on mood and function in~     individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression,~     fatigue, trouble concentrating, or memory loss. This will be a phase one study. The~     investigators will monitor patients over a period of three to six months while on the~     medication. Medication levels will be monitored by measuring the BH4 levels in cerebral~     spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up~     lumbar punctures for this purpose. The investigators will also monitor emotional function~     and motor function.~   "
124519|NCT01425775|"~     Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune~     disease. Vitamin D has potent immunomodulatory properties that have promoted its potential~     use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status~     in SLE patients and determined alterations in inflammatory, hemostatic markers as well as~     disease activity before and after vitamin D supplementation.~      248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were~     randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months.~     Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18,~     TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12~     months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were~     measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were~     classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The~     mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in~     controls.~   "
124520|NCT01425762|"~     This is a randomized controlled study that will place patients into a choice and a no~     choice group. The choice group will be able to choose between receiving 100 mcg or 200 mcg~     intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or~     200 mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured~     at 3, 6, 12, 24, and 36 hours.~   "
124521|NCT01425749|"~     The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined~     with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer~     Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites,~     intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data~     on the immunological response to ASCI in the injection site microenvironment, in the node~     draining the vaccine site (sentinel immunized node) and in the blood and whether there are~     large differences in the magnitude, persistence, or type of immune response induced as a~     function of the ASCI injection. Evaluation of immune responses to the ASCI will include,~     amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.~   "
124522|NCT01425736|"~     Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II~     clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved~     satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head~     and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with~     conventional definitive chemotherapy might improve the rate of disease control (RDC),~     progression-free survival (PFS),and overall survival in patients with recurrent and/or~     metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently~     no standard treatment approach, we designed this trial to test this hypothesis.~   "
124523|NCT01425723|"~     The primary objective of the study is to evaluate the long-term safety of rFIXFc in~     participants with hemophillia B.~      The secondary objective of this study is to evaluate the efficacy of rFIXFc in the~     prevention and treatment of bleeding episodes.~   "
124524|NCT01425710|"~     Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR),~     corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during~     laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative~     changes in volume status and to estimate the volume depletion.~   "
124525|NCT01425697|"~     The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical~     site infections in patients having elective cardiac surgery.~   "
124526|NCT01425684|"~     The principle aim of the project is to identify the key brain circuits associated with~     smoking and especially smoking in high risk population. The investigators hope that the~     study will provide concrete biomarkers for new therapeutic development and ultimately~     reducing the smoking related health burden.~   "
124527|NCT01425671|"~     The principle aim of the project is to analyze brain electrical activity and genetic~     information that will help identify the nature and cause of the disease schizophrenia. This~     effort should lay the groundwork for future treatment in schizophrenic patients.~   "
124528|NCT01425658|"~     Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an~     additive to bupivacaine in patients undergoing cesarean section .~      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients~     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal~     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were~     randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received~     bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group~     (group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group~     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time~     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory~     level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of~     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen~     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,~     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were~     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no~     pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the~     patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for~     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of~     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.~   "
124539|NCT01425515|"~     The investigators are conducting a single group intervention study to improve blood pressure~     control and reduce racial and literacy related disparities among people with hypertension.~     The intervention includes providing patients with home blood pressure monitors,~     administering phone-coaching to participants, and improving hypertension care at the~     participating practices from which patients are enrolled. The investigators will follow the~     patients for 2 years to determine if blood pressure control improves. In addition, the~     project will explore genetic factors associated with cardiovascular disease risk and~     treatment success.~   "
124540|NCT01425502|"~     A cluster randomised controlled trial to test the effectiveness of an informatics tool,~     educational and financial incentives to reduce high risk prescribing of non-steroidal~     anti-inflammatory drugs and anti-platelet agents.~   "
124529|NCT01425645|"~     No evidence-based, evaluated, population-appropriate resources exist to translate Type 2~     diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such~     large-scale interventions include:~        -  the need to identify, then target specific at-risk populations~        -  significant time-delays before any program effects on T2DM incidence may manifest.~      However, women with gestational diabetes (GDM) are a readily identifiable study cohort at~     significant risk for recurrent GDM and T2DM—hence GDM women provide important opportunities~     for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD~     (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely~     targeting women with recent GDM in the context of their families.~      FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with~     recent GDM, within their family context. Five Canadian sites and 177 women will participate.~     Multifaceted information and behavioural change support will be provided for diet, weight~     loss, and activity through: seminar, walking groups, electronic updates, password-protected~     social networking site.~      Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices;~     HbA1C; body habitus at study onset/during study/12 months/24 months.~      Consenting immediate family members will have protective knowledge/diet/exercise~     choices/body habitus measures documented at study onset/12 and 24 months.~   "
124530|NCT01425632|"~     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after~     two weeks of administration to pediatric patients with perennial allergic rhinitis, and to~     investigate the dose response, safety, and plasma concentrations of TAU-284.~   "
124531|NCT01425619|"~     Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing~     this procedure. The investigators intend to examine if medical clowns compared with local~     anesthetic cream can decrease these feelings in children.~   "
124532|NCT01425606|"~     Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by~     using the stewart approach to acid - base interpretation, would like to show that the~     positive charged m- proteins produced in m.m.result in true hyponatremia.~   "
124533|NCT01425593|"~     Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause~     is not detected after intensive clinical and laboratory investigation.In view of the current~     data, it was suggested that at least part of the patients with CIU have an autoimmune~     process.This study is designed to investigate the mechanisms involved in the regulation and~     activation of the immune cells in patients with CIU and corelate them with disease activity~   "
124534|NCT01425580|"~     Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin with insulinotropic~     properties. Apart from the glycemic actions, cardiovascular effects by GLP-1 have recently~     been reviewed. Receptors for GLP-1 are expressed in the rodent and human heart and acute~     activation of GLP-1 signalling has been shown to influence e.g. heart rate and blood~     pressure. In a knock-out mouse model, GLP-1R-/- mice exhibited a defective cardiovascular~     contractile response together with left ventricular hypertrophy. GLP-1 improves severe left~     ventricular heart failure in humans suffering from a myocardial infarction. Hence, it has~     been demonstrated that GLP-1 exerts direct functional effects through both GLP-1 receptor~     dependent and independent pathways in the heart.~      Native GLP-1 is an extremely short acting peptide, with a half-time breakdown of 1-2~     minutes, a feature that makes it unsuitable as a drug treatment for type 2 diabetes. To this~     end, several long-acting GLP-1 analogues, drugs for treating type 2 diabetes, have been~     tested for this purpose. The analogue liraglutide exerts its effects via the native GLP-1~     receptor, localized not only on the pancreatic β-cells, but also in the human heart.~     Interestingly, liraglutide has been demonstrated to have beneficial effect on heart function~     in mice. Taken together, recent data shows that GLP-1 and its stable analogue liraglutide~     exert beneficial cardiovascular effects.~      The purpose of this study is to determine whether the glucagon-like peptide-1 (GLP-1)~     analogue liraglutide improves heart function (measured as left ventricle longitudinal~     function and/or functional reserve during rest and/or after exercise) after 18 weeks of~     liraglutide + metformin, compared with glimepiride + metformin, using tissue Doppler~     echocardiography.~   "
124535|NCT01425567|"~     If a child is unable to tolerate enough of his/her feeding orally to grow and requires that~     nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease.~     This is called cholestasis. IV fat that children receive may be contributing to this liver~     disease. A different fat mixture comprised from fish oil could be used in place of~     intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We~     believe the use of fish oil may provide less liver disease and decrease the need of liver~     transplant or dying than those who receive the usual fat.~   "
124536|NCT01425554|"~     This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography~     and air-plethysmography for the assessment of abnormalities in the internal jugular veins,~     with catheter venography as the reference test.~   "
124537|NCT01425541|"~     Girls with high levels of the male hormone testosterone often develop polycystic ovary~     syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess~     facial and body hair, and weight gain. Women with PCOS also have difficulty becoming~     pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as~     they grow up. Most girls continue to have high levels of male hormone as adults. In~     addition, girls with elevated levels of male hormones often have lower fertility rates in~     adulthood. In this study the investigators will aim to discover the effect of 7 days of~     estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding~     how and why some girls and women have higher levels of male hormone and the causes of PCOS.~     If investigators understand the causes of these disorders, they may be able to better treat~     them and perhaps even learn how to prevent the development of PCOS.~   "
124541|NCT01425489|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Krabbe~     Disease from plasma~   "
124542|NCT01425476|"~     This is a biomarker study with the goal of measuring changes in proteins and gene~     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,~     or preventing disease.~      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in~     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), to~     decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of~     breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.~   "
124549|NCT01425385|"~     Patients with liver failure undergoing liver transplantation often have clinical or~     sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may~     lead to abnormal regulation of blood flow to the brain (cerebral autoregulation)~     complicating patient management during and after general anesthesia. The current methods for~     monitoring for elevated intracranial pressure are invasive and, thus, limited to severe~     encephalopathy. In this study the investigators will evaluate the potential utility of~     monitoring cerebral blood flow autoregulation non-invasively using near infra-red~     spectroscopy in patients undergoing liver transplantation.~   "
124550|NCT01425372|"~     Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly~     among young children. Over 30 different types of the pneumococcus germ can cause invasive~     disease, but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for~     around 75% of cases in young children. A pneumococcal conjugate vaccine against these 7~     serotypes (PCV7; Prevenar ®, Wyeth Vaccines) was introduced into the UK national~     immunisation programme in September 2006 and has resulted in a rapid reduction in~     pneumococcal disease caused by the 7 serotypes among both vaccinated children and older~     unvaccinated children and adults through herd immunity. By 2009, over half of all invasive~     pneumococcal cases in young children were caused by six other pneumococcal serotypes (1, 3,~     5, 6A, 7F and 19A) that are included in a newly licensed 13 valent pneumococcal vaccine~     (PCV13; Prevenar 13®, Wyeth Vaccines). In April 2010, PCV13 replaced PCV7 in the UK~     immunisation programme with the aim of further reducing cases of invasive pneumococcal~     disease. The antibody responses induced by the 7 serotypes in both PCV13 and PCV7 have been~     shown to be comparable, but the protection offered by the additional 6 serotypes in PCV13~     merits further study. Also, it is possible that the use of PCV13 instead of PCV7 may~     interfere with immune responses to other vaccines, such as Haemophilus influenzae serotype b~     (Hib), which are given to infants at the same time as PCV13. The proposed study will aim to~     collect one blood sample from infants after they receive their routine vaccinations at 2, 3~     and 4 months in order to their measure immune responses to routine vaccines. The~     investigators hope that their results will help us better understand the added protection~     offered by the 13valent pneumococcal vaccine and ensure that children are adequately~     protected by the other vaccines they receive.~   "
124551|NCT01425359|"~     This study will evaluate the effect of ranolazine compared to placebo on the average weekly~     angina frequency in subjects with chronic stable angina and coronary artery disease (CAD)~     who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the~     frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to~     record their daily angina episodes in a diary at the end of each study day. Ranolazine is~     approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.~   "
124552|NCT01425346|"~     The goal of this study is to measure lens fluorescence in normal subjects at various~     chronological ages that could serves as a guide to clinicians in determining changes in eye~     health. A measure of lens fluorescence can be used by clinicians as an indication of~     degenerative changes occurring in the lens of the eye.~   "
124553|NCT01425333|"~     The aim of this study is to assess which of two commonly used surgical procedures in the~     treatment of ovarian cysts called endometriomas (cutting out of the cyst - cystectomy, or~     draining it and cauterising it's inner lining - ablation) causes the least damage to the~     ovary and is therefore best at maintaining the future fertility potential of a patient.~   "
124554|NCT01425320|"~     This study will investigate the pharmacokinetics, safety and tolerability of dapsone and~     adapalene following topical administration of 2 formulations of dapsone/adapalene fixed~     combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects~     with acne vulgaris.~   "
124555|NCT01425307|"~     The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative~     therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle~     cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who~     currently receive chronic transfusions to reduce the risk of primary stroke. For the~     alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard~     treatment regimen (transfusions), after adjusting for baseline differences, the~     hydroxyurea-treated group must have a mean TCD velocity similar to that observed with~     transfusion prophylaxis.~   "
124556|NCT01425294|"~     This study is a post-authorisation pharmacoepidemiology study, committed to Center for Drug~     Evaluation (CDE) and State Food and Drug Administration (SFDA), in order to provide more~     efficacy and safety data about Faslodex 250mg in real life clinical practice in China. The~     objective of the post marketing study is to explore the efficacy and tolerability of~     Fulvestrant (FASLODEX™)250 mg in postmenopausal women with oestrogen receptor positive,~     locally advanced or metastatic breast cancer for disease relapse on or after adjuvant~     anti-estrogen therapy or disease progression on therapy with an anti-estrogen.~   "
124557|NCT01425281|"~     Prospective, randomized (2:1), active control, single blinded, parallel two-arm,~     multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting~     Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE~     Everolimus Eluting Coronary Stent System (XIENCE)~   "
124558|NCT01425268|"~     This study is designed to compare the performance and safety of the AirXpander tissue~     expander to standard saline expanders in patients undergoing two-stage breast reconstruction~     following mastectomy.~   "
124559|NCT01425255|"~     The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake~     patterns in parents of children with type 1 diabetes (T1D) before and several weeks after~     initiating using real-time continuous glucose monitoring (RT-CGM) of their children.~   "
124560|NCT01425242|"~     Inflammation of the blood vessel plays an important role in the development and growth of a~     dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation,~     therefore blood pressure lowering is an important part of the treatment of patients with a~     dilated abdominal aorta who also have an elevated blood pressure. In the investigators study~     the investigators compare the anti-inflammatory effects of 2 different blood pressure~     lowering strategies. The investigators hypothesize that both strategies will decrease~     inflammation, however the investigators believe the total decrease of inflammation depends~     on the type of blood pressure lowering medication used.~   "
124561|NCT01425229|"~     The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1*15 vs.~     wild type; ~2% SLCO1B1*15 haplotypes in Caucasian population) and the CYP2C9 genotype (*2~     and *3 allele vs. wild type; ~5% poor metabolisers in Caucasian population) on the~     pharmacokinetics of bosentan and the impact of CYP3A4-inhibition by clarithromycin on steady~     state bosentan which is a CYP3A4 inducer itself.~      This study will focus on differential effects of genotypes and co-medication on the~     pharmacokinetics of bosentan at the metabolic and transport level. Participants will be~     genotyped for CYP2C9 (inclusion criterion), OATP1B1 (inclusion criterion), and CYP3A5 (no~     inclusion criterion).~   "
124563|NCT01425203|"~     The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in~     combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective~     in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The~     primary hypothesis is that the percentage of participants achieving sustained virologic~     response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.~   "
124564|NCT01425190|"~     This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir~     following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric~     participants.~   "
124565|NCT01425177|"~     In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for~     the removal of bile duct stones.~      After procedures, there are some complications such as stone recurrence, papillary stenosis,~     cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite~     increasing experience and success with the procedure, occur in 4% to 24% of patients.~      Gallbladder stone, pneumobilia and many other various factors are known to be associated~     with CBD stone recurrence. Lithotripsy was also related to the development of recurrent~     stones. It is natural that small stone fragments left after lithotripsy may act as nidi for~     stone recurrence.~      Small remaining stone could not be completely detected only using ERCP stone removal and~     remaining stone removal can reduce residual and recurrent stones. Saline irrigation was~     effective immediately after ERCP stone removal to remove remaining small stones.~      Saline irrigation has many advantages such as easy to treatment during ERCP stone removal,~     almost no additional cost and rare side effect. This study The authors expect this study is~     a remarkable role of ERCP stone removal procedure.~   "
124566|NCT01425164|"~     In hemodialysed patients, coronary heart disease is the leading cause of mortality and~     morbidity. Most of the commonly used drug for ischemia are used in this patients, but few~     prospective data are available. Among anti-ischemic drugs betablocker provided evidence of~     beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used~     also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of~     benefit in general population, but no study is available in dialysis patients. Aim of the~     present study is to compare in a randomized, double-blind, parallel group trial the effects~     of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed~     population of patients with established coronary heart disease.~   "
124567|NCT01425151|"~     In the following randomized, crossover study, the investigators test the hypothesis that~     ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the~     i-GelTM in anesthetized pediatric patients.~   "
124568|NCT01425138|"~     This project involved a systematic literature review of published trials of treatments for~     moderate-to-severe plaque psoriasis. Data was extracted from the publications on various~     psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life~     Quality Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed~     treatment comparison was conducted on the extracted data.~   "
124569|NCT01425125|"~     Hyponatremia, defined as a serum sodium < 135 mmol/l, in patients without edema has~     undergone significant changes where it is now evident that even mild hyponatremia should be~     treated because of its association with symptoms, especially a fourfold increase in falls~     over the age of 65 years. There is an unresolved controversy over the relative prevalence of~     the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) and cerebral/renal~     salt wasting (C/RSW). Resolution of this diagnostic dilemma becomes urgent because of~     divergent therapeutic goals, to water-restrict in SIADH or to give salt and water~     supplementation in C/RSW. The dilemma is compounded by recent reports of C/RSW occurring in~     patients without cerebral disease, thus adding further confusion in defining the relative~     prevalence of both syndromes. Because of overlapping laboratory and clinical findings in~     both syndromes, only differences in the state of extracellular volume differentiates one~     syndrome from the other, being high normal to increased in SIADH and decreased in C/RSW. The~     investigators have used fractional excretion (FE) of urate to categorize patients with~     hyponatremia. The increased FEurate that is observed in hyponatremic patients with SIADH and~     C/RSW can be used to differentiate both syndromes by correcting the hyponatremia and~     determining whether FEurate normalizes as in SIADH or remains increased in C/RSW. The~     present studies have been designed to determine total body water by deuterium and~     extracellular water by sodium bromide in patients with nonedematous hyponatremia with normal~     and increased FEurate to differentiate more conclusively whether the patient has normal or~     decreased water volumes. The investigators will also correct serum sodium rapidly with~     judicious administration of hypertonic saline over approximately three days and determine~     whether FEurate normalizes as in SIADH or remains increased as in C/RSW. In another group of~     patients, The investigators have data to suggest that those with normal sodium and increased~     FEurate is consistent with C/RSW. The investigators intend to do the same water volume~     studies to determine whether an increased FEurate with normonatremia would have decreased~     total and extracellular water that these patients have C/RSW without the need to correct a~     prior hyponatremia.~   "
124570|NCT01425112|"~     Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known~     to reduce neovascularization and fibrovascular proliferation in inflammatory conditions,~     including post-operative inflammation. It has shown efficacy in numerous ocular~     conditions(off-label), that includes Age related macular degeneration, proliferative~     diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being~     explored as an option for preventing recurrence of pterygium and as an adjunct to improving~     outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab~     administration for trabeculectomy. This study aims to compare a single subconjunctival dose~     of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy~     surgery, non-progression of field loss and stable intraocular pressure(IOP) control.~   "
124571|NCT01425099|"~     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3~     clinical development for the treatment of human immunodeficiency virus (HIV) infection. DTG~     is primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450~     (CYP)3A4 pathway as a minor route. Corticosteroids have demonstrated induction effects on~     UGTs and CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the~     potential to reduce DTG exposure due to enzyme induction when co-administered. The primary~     objective of this study is to determine whether concomitant prednisone administration can~     affect the pharmacokinetics (PK) of DTG.~      The study is a two part, two period, open label study. Part 1 will evaluate the effect of a~     high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the~     results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h~     for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with~     prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period~     2. PK data of DTG will be obtained from Part 1 and used to inform decision making on the~     need for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be~     carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in~     Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed~     by a 5 day taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK~     samples for DTG will be collected during each treatment period. A follow-up visit will occur~     7-14 days after the last dose of study drug. All doses of study drugs will be taken~     following a moderate fat meal. This study will be conducted at one center in the United~     States, with healthy adult male and female subjects.~   "
124572|NCT01425086|"~     The purpose of this pilot study is to evaluate the performance of a new warming technology~     (Embrace Isothermal Mattress) during the thermal weaning of premature infants from~     incubators to open cribs. The investigators aim to study the Embrace Isothermal Mattress~     over a 24-hour period before the infant is transitioned out of the incubator.~   "
124573|NCT01425073|"~     Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been~     associated with significantly decreased mortality in HIV-infected individuals.~     Trimethoprim-sulfamethoxazole (TMP/SMZ), also known as bactrim, is a common antibiotic and~     used as prophylaxis for OIs. For countries with high prevalence of HIV and limited health~     infrastructure, the WHO endorses universal TMP/SMZ for all HIV-infected individuals.~     Notably, these guidelines were created prior to the scale-up of ARTs. Following ART and~     subsequent immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for~     example, TMP/SMZ is discontinued after patients show evidence of immune recovery. Therefore,~     we propose a prospective randomized trial among HIV infected individuals on ART with~     evidence of immune recovery (ART for > 18mo and CD4 >350 cells/mm3) to determine whether~     continued TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia,~     diarrhea), mortality, CD4 count maintenance, ART treatment failure and malaria immune~     responses.~   "
124574|NCT01425060|"~     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was~     unintended and the majority of non-pregnant opioid-maintained women do not use contraception~     or use less effective methods like condoms. This proposal aims to develop and test a novel~     contraceptive management program to increase use of more effective contraceptives among~     opioid-maintained women and to examine the impact of more effective contraceptive use on~     condom use. The proposed research may reduce unintended pregnancy among opioid-dependent~     women without increasing their risk of sexually transmitted infections and the knowledge~     gained will also have implications for addressing high rates of unintended pregnancy in the~     general population.~   "
124575|NCT01425047|"~     Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine.~     The purpose of this study was to determine the bioavailability of the xanthones from~     mangosteen juice in adult human subjects.~   "
124576|NCT01425034|"~     Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity~     treated by hand surgeons in our society. It can be a significant source of functional~     disability secondary to a painful, and often weak, grip. Once patients have failed treatment~     by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the~     next option is surgical management. Several surgical options are available depending on the~     severity of the disease. For the early stages of arthritis options include a ligament~     reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage~     procedures exist. These have included simple trapeziectomy, arthrodesis and implant~     arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament~     reconstruction tendon interposition~   "
124577|NCT01425021|"~     The goal of this is to improve durability of total joint replacements in patients, thereby~     improving clinical outcomes and implant performance. To reach this objective, our research~     program would like to assess the safety, efficacy, performance, and durability of FDA~     approved biomaterial and implant designs used in joint replacements.~   "
124578|NCT01425008|"~     This is a phase 1, multicenter, nonrandomized, open-label, dose escalation study. The study~     will be conducted in 2 stages, Dose Escalation and Dose Expansion. The Dose Escalation phase~     will include patients with solid tumors (including melanoma) who have failed or are not~     candidates for standard therapies or for whom no approved therapy is available. The Dose~     Expansion phase will include patients with metastatic melanoma.~   "
124579|NCT01424995|"~     This will be a prospective study of all children ages 0 - 5 years old at the time of entry~     into the study that meet the inclusion criteria who present with congenital trigger thumb.~     Patient records will be reviewed for eligibility before obtaining parental permission. They~     will be enrolled in the study at their first visit and followed every year for up to 4 years~     or until one of the exclusion criteria are met. Participating sites include the University~     of Utah Orthopaedic Center, Primary Children's Medical Center and Shriners Hospital for~     Children.~   "
124580|NCT01424982|"~     The goal of this clinical research study is to learn if intensive chemotherapy combined with~     ponatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome~     and/or BCR-ABL. The safety of this treatment will also be studied.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the~     location of the clot, this could cause a heart attack, a stroke, severe damage to other~     tissue, or death. A blood clot may occur within 2 weeks after you start taking the drug.~     About 25% (1 in 4) of patients taking the drug form an abnormal clot. Blood clots can occur~     in patients that do not have other known risk factors for forming clots. If you develop a~     blood clot, you will need to stop taking ponatinib. In some cases, emergency surgery could~     be needed to remove the clot and restore blood flow.~   "
124581|NCT01424969|"~     The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM)~     augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional~     outcome scores. The investigators performed an observational cohort study in which a~     consecutive series of patients with rotator cuff tears at risk for retear was prospectively~     evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance~     imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls~     with similar at-risk tears without PRFM augmentation.~   "
124602|NCT01424696|"~     Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive~     problems, but can now be diagnosed at the time of birth. Lung function is very hard to~     measure in infants, but growth is not. In this study the investigators aim to define growth~     in infants with CF in the first year of life with research quality precision and to~     understand factors that interfere with good growth.~      Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of~     infants. Two different doses of PERT will be evaluated for improving fat and nitrogen~     absorption in infants with CF.~   "
124603|NCT01424683|"~     The objective of this study is to investigate how mobility and pain scores, measured on a~     Visual Analogue Scale (VAS), correspond to patients' EuroQol-5Dimensions-3Levels (EQ-5D-3L)~     answers on pain and mobility. In addition, the investigators want to evaluate patients'~     undergoing Coronary Artery Bypass Grafting (CABG) quality of life postoperatively, depending~     on the vein harvesting method used.~   "
124604|NCT01424670|"~     The purpose of this trial is to determine whether delamanid is effective in the treatment of~     Multidrug-resistant Tuberculosis (MDR TB) in combination with other MDR TB medications~     during 6 months of treatment.~   "
124582|NCT01424956|"~     To determine the impact on Interpreting Physician performance in detecting breast cancer, as~     defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated~     Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening~     mammography alone in asymptomatic women with >50% parenchymal density and a screening~     mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign~     findings).~      The effect of the improved Reader performance is illustrated by plotting the ROC curves for~     XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM,~     the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area~     under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS.~     The null and alternative hypotheses can be formally expressed as follows:~      H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance~     will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS~     Assessment Category of 1 or 2.~      HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader~     performance will be changed with the addition of ABUS to a screening mammogram assigned a~     BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered~     equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS~     is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05~     for a two-sided test.~   "
124583|NCT01424943|"~     The purpose of the project is to assess the initial efficacy of Stepping Stones Triple~     P-Positive Parenting Program (SSTP) with parents of children below age two with~     developmental disabilities to strengthen families and prevent child maltreatment.~   "
124584|NCT01424930|"~     The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone~     acetate and oral prednisone following short-term administration after standardized low-fat~     or high-fat meals to patients with metastatic (spreading) castration-resistant prostate~     cancer (mCRPC).~   "
124585|NCT01424917|"~     Post transplant vasculopathy is a major negative outcome in heart transplantation. Current~     methods of detection are highly invasive and pose a risk to transplant recipients.~     Noninvasive markers of endothelial function can be used to detect transplant vasculopathy.~     Endothelial biomarkers such as: endothelial nitric oxide synthase, vascular cellular~     adhesion molecules, intracellular adhesion molecules, endothelin-1, thromboplastin,~     circulating endothelial cells, uric acid, and C-reactive play a role in the pathophysiologic~     mechanism of vasculopathy. Therefore, the investigators would like to assess the association~     between various endothelial biomarkers and the presence or absence of transplant~     vasculopathy.~   "
124586|NCT01424904|"~     The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40‐km~     time trial in trained male cyclists. The investigators believe that DGB-01 will improve~     performance on the time trial as measured by a reduction in the amount of time required to~     complete the distance, using a computerized cycle ergometer.~   "
124587|NCT01424891|"~     Lowering LDL cholesterol by statins has been proven to be associated with reduction of~     proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the~     effects of newer cholesterol lowering agents such as ezetemibe with respect to their~     anti-inflammatory potential are less intensively studied. Therefore the investigators~     analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination~     with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear~     cells (PBMCs) of patients with type 2 diabetes.~   "
124588|NCT01424878|"~     Background:~      Medullary thyroid carcinoma (MTC) is a rare malignancy, occurring either as a sporadic~     disease (75% of cases), or in a hereditary pattern as multiple endocrine neoplasia (MEN)~     type 2 (MEN2A or MEN2B) or familial medullary thyroid carcinoma (FMTC). The MTC arises from~     the neural crest C-cells and in hereditary cases the first pathological disorder is C-cell~     hyperplasia (CCH) Most patients with MTC have advanced disease at the time of diagnosis.~      Chemotherapy and external beam radiotherapy have been minimally effective. Molecular~     targeted therapeutics (MTTs) and other receptor kinases in patients with advanced MTC have~     demonstrated activity.~      Despite some clinical responses, the collection of tumor tissues and autologous normal~     tissues has been virtually non-existent. Thus, laboratory studies defining affected~     molecular targets and downstream pathways, and molecular data providing direction for future~     clinical trials has yet to occur.~      Data from molecular studies of tumor tissue of hereditary or sporadic MTC patients will~     assist in predicting clinical behavior and the biology of MTC in predicting response to a~     given MTT, and in designing combination clinical trials.~      Objectives:~      Clarify how normal molecular pathways are altered by mutations in the RET protooncogene.~     Including additional genetic mutations and unidentified chromosomal translocations.~      Correlate results from molecular analyses of MTC tissue with patient s clinical course.~      Define how the molecular and clinical data will be useful in designing targeted therapy for~     patients with MTC.~      Eligibility:~      Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic MTC~     with archived pathology specimens available at Washington University.~      Design:~      Paraffin blocks of MTC tissues from archival samples at Washington University Department of~     Pathology will be selected.~      H&E slide from selected tissue blocks will be examined for molecular study suitability.~      Necessary tissue samples from blocks will have molecular studies, including, gene arrays,~     array comparative genomic hybridization, immunohistochemistry, and sequencing.~      Retrospective chart review will occur to obtain relevant clinical information.~   "
124589|NCT01424865|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in~     samples from patients with breast cancer previously treated in the NSABP-B-31 trial.~   "
124590|NCT01424852|"~     Aim: to examine caries occurrence in children who ten years ago received a mixture of~     probiotics during infancy.~      Hypothesis: the administration of probiotics during infancy has no effect on future dental~     health.~   "
124605|NCT01424657|"~     The main objective of this study is to assess the effectiveness and costs of magnetic~     resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde~     cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct~     obstruction on ultrasound. The investigators do not anticipate that a universal~     recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all~     patients presenting with bile duct obstruction. Rather, the investigators hope to provide~     quantitative and comparative data relevant to the different clinical situations likely to be~     encountered in practice, in order to assist physicians in choosing the appropriate~     diagnostic modality. More specifically, the investigators feel that patients with~     intrahepatic or hilar obstruction (particularly those with malignant conditions), and those~     with partial common bile duct (CBD) obstruction (to rule out suspected choledocholithiasis)~     will benefit most from this new technology and the avoidance of an unnecessary ERCP to~     further determine the biliary anatomy.~   "
124591|NCT01424839|"~     STUDY DESIGN:~      Prospective, non-randomised multicentre study with patients stratified according to risk~     groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin, Cisplatin,~     Ifosfamide and Etoposide (as approved by German competent authority).~      PRIMARY OBJECTIVES:~      Germinoma~        -  To maintain current high event-free survival (EFS) rates using a risk adapted approach~        -  In localised germinoma: to omit whole brain and spinal irradiation by using combined~          treatment with standard chemotherapy and ventricular irradiation (+/- boosts)~        -  In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to~          omit whole brain and spinal irradiation by using combined treatment with standard~          chemotherapy and ventricular irradiation (+/- boosts)~        -  In metastatic disease: to maintain current excellent EFS in metastatic germinoma with~          craniospinal irradiation Malignant non-germinoma~      To improve EFS:~        -  by dose escalation of chemotherapy in patients identified as high risk at diagnosis (~          age < 6 years and/or AFP serum / CSF > 1000 ng/ml)~        -  by standardising the surgical approach for residual disease after treatment Teratoma~        -  To register patients and collect data regarding diagnostics, treatment and outcome in~          order to develop future treatment strategies~      SECONDARY OBJECTIVES:~      Germinoma~        -  To minimise long term effects of irradiation by sparing spinal and whole brain~          radiotherapy in non-metastatic disease Malignant non-germinoma~        -  In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma~        -  To evaluate the influence of surgery and treatment on outcome to assist in the~          development of a fu-ture treatment strategy For all histological subtypes~        -  To improve accuracy of diagnosis and staging in all registered patients~        -  To standardise neurosurgical intervention~        -  For all patients requiring biopsy or resection according to protocol guidelines, to~          collect and to store tumour material, and CSF where possible, for use in future~          biological studies.~      ENDPOINTS / Criteria for evaluation:~      Main end point~      Event-free survival, defined as minimum time from the date of diagnosis to:~        -  Death from any cause~        -  Relapse~        -  Progressive disease on therapy~        -  Or second malignancy~      Secondary end points~        -  Overall survival, defined as time to death from any cause, measured from the date of~          diagnosis~        -  Short and long term toxicity.~   "
124592|NCT01424826|"~     This study seeks to address the question of whether intermittent dosing of rifampicin~     influences the pharmacokinetics of raltegravir when co-administered. This study aims to look~     at what happens when rifampicin is taken 3 times a week with the standard dose and an~     increased dose of raltegravir. This is to find out the best dose of raltegravir to take when~     taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.~   "
124593|NCT01424813|"~     The study will measure the change in lung function in subjects with asthma after inhaling~     from either of two inhalers: Albuterol Spiromax® or placebo.~   "
124594|NCT01424800|"~     This study emphasizes on the influence of changes in systemic flow and systemic mean~     arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation~     assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether~     variations in systemic flow, in MAP, or in both variables at the same time have the greatest~     impact on the cerebral oxygen saturation.~   "
124595|NCT01424787|"~     The objective of this non-interventional study is to confirm that with standard OsvaRen®~     treatment it is possible to achieve in at least 60% of the patients the levels of~     phosphorus, total calcium, and iPTH seen in the CALMAG study also in the normal clinical~     practice.~   "
124596|NCT01424774|"~     This study will be performed at clinical sites that have administered CardioGen-82® to~     patients from January to July 2011. The patients enrolled(i.e., target date patients) will~     be all those who were dosed at the end of use of the CardioGen-82® generators on the last~     day of generator use from the generator that was used immediately prior to the recalled~     generator (i.e., target date generators). These are not patients who received drug eluted~     from the recalled generator. Of these patients, it is planned that 100 patients will be~     entered in this trial.~   "
124597|NCT01424761|"~     Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association~     (AHA) indicated that CVD patients with Statin therapy would decrease the recurrence of CVD.~     The goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein~     cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble~     antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the~     purposes of this study are going to investigate the relation of coenzyme Q10 with other~     antioxidant vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant~     enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients~     during Statin therapy. The study is going to design a placebo-controlled study. The~     investigators will recruit coronary artery disease (CAD) patients who are identified by~     cardiac catheterization as having at least 50% stenosis of one major coronary artery, and~     healthy subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements~     (150 mg/bid = 300 mg/d) groups. Intervention is going to administration for three months.~     Fasting blood will be obtained in each month and determine the concentration of antioxidant~     vitamins, lipid peroxidation markers, antioxidant enzymes activities after intervention.~     Meanwhile, the investigators will measure the level of inflammatory markers in all subjects~     of this study. Hopefully, the results of this study could provide information of coenzyme~     Q10 supplementation for clinical dietitian in advising CAD patients who are under Statin~     therapy.~   "
124598|NCT01424748|"~     For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni~     juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital~     signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well~     as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be~     made for each volunteer during the pre-study screen and at week 6.~   "
124599|NCT01424735|"~     Although idiopathic steroid resistant optic neuritis is very uncommon, there is no~     established treatment protocol for such patients. Toll like receptors (TLRs) especially~     TLR-9 has been shown to play a role in the pathogenesis of optic neuritis. This small case~     series aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9~     antagonism)play any role in improving the visual function in such patients.~   "
124600|NCT01424722|"~     This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption~     (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the~     ST Monitoring Feature in St Jude Medical ICD systems.~   "
124601|NCT01424709|"~     Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced~     non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel~     or CPT-11 are standard 1st regimens. BRCA1 and RRM1 expression levels are reported to be~     associated with sensitivity of the tumor cells to cytotoxic agents. Some Phase II or III~     trials did prove feasibility of customized chemotherapy based upon expression levels of one~     or two biomarkers in the NSCLC patients. The investigators think customized chemotherapy may~     further improve efficacy of chemotherapy in advanced NSCLC. But there is no randomised trial~     to compare efficacy of standard chemotherapy with individualized chemotherapy in this~     setting. So, the investigators plan to initiate this phase II trial to compare efficacy~     between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in~     chemonaive NSCLC patients.~   "
124609|NCT01424605|"~     Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and~     also played an important role to achieve one-lung ventilation (OLV) for exploring the~     surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT~     had larger OD (outer diameter), longer length, and was more complex in its structure. For~     avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and~     complete glottic viewing under laryngoscope was needed.~      Over the past decade, several video-assisted laryngoscopes had been developed to facilitate~     the tracheal intubation in the difficult airway. Among these devices, the GlideScope®~     videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with~     a 60° curvature blade. A light source and a digital video camera were installed at the tip~     of the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed~     on an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the~     trachea more precisely and had less tissue damaging under the GVL's guidance.~      Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease~     the intubation time and increase the successful rate of first intubation in normal and~     difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and~     had never been evaluated. Therefore, the aim of this study was to compare the intubation~     conditions, safety, and patient comfort between using the GVL and the direct Macintosh~     laryngoscope in a specific population of patients needed DLT intubation. Main outcome~     measures were intubation success rates and the time needed to intubate the DLT with the two~     devices.~   "
124610|NCT01424592|"~     Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having~     OSA is accurate in determining the need for positive airway pressure (PAP) therapy when~     compared to outpatient laboratory-based polysomnography.~        -  Hospitalized medical inpatients referred for suspected OSA will be tested with a~          portable sleep apnea testing device during hospitalization.~        -  These patients will then undergo an outpatient laboratory-based attended~          polysomnography after hospital discharge.~        -  Results of the inpatient portable sleep apnea test will be compared to the outpatient~          laboratory-based polysomnography in terms of diagnostic accuracy.~   "
124611|NCT01424579|"~     Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high~     lifetime prevalence (one in three) in general population. In occupational population is the~     most common upper extremity disorder. Symptoms include pain, a variable degree of mobility~     limitation and a more or less pronounced functional impairment. Conservative treatment is~     usually the first therapeutic option and some physiotherapeutic techniques have proved its~     efficacy but nevertheless treatment remains challenging.~      According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial~     effect on patients suffering from SIS, but no one published clinical trial has evaluated~     this manual technique previously. The investigators hypothesis is that adding Diacutaneous~     Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The~     investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain,~     mobility and functional status in patients suffering from SIS.~      A double-blind (patient and evaluator) randomized clinical trial was carried out in two~     public centres of Primary Health Care of the Spanish National Health System. The study~     protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute~     of Research in Primary Health Care and all the patients provided written consent.~      A hundred and twenty patients with clinical diagnosis of SIS were included and randomly~     allocated to one of three groups. All groups received the same daily protocolized treatment~     based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks.~     Additionally, intervention group received six sessions (two a week) of actual Diacutaneous~     Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous~     Fibrolysis, while control group received only the protocolized treatment.~      Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and~     internal rotation) and functional status (Constant-Murley score) were measured in baseline,~     after the three weeks of treatment and three months after the end of treatment.~   "
124612|NCT01424566|"~     The primary objective of this study is to determine the efficacy of Sativex, compared with~     placebo, an adjunctive medication in relieving persistent chronic pain (not breakthrough~     pain) in patients with advanced cancer, who have this pain even when they are on~     optimized/maximized chronic opioid therapy.~      This multi-center study will be conducted in two parts. All participants enrolled into the~     trial will receive Sativex during one of two parts of the study, but they will not know~     which part.~      Eligible patients will not be required to stop any of their current treatments or~     medications.~   "
124613|NCT01424553|"~     EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be~     evaluated in very low birth weight and term infants, born in 1997 and included in the French~     EPIPAGE cohort.~   "
124614|NCT01424540|"~     This is a single-center, randomized, two part, double-blind, crossover study in healthy~     adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function~     comparing with placebo using echocardiography as a primary assessment modality~   "
124615|NCT01424527|"~     This is a cross-sectional validation study, designed to evaluate the discriminative validity~     of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language~     in patients with Chronic Obstructive Pulmonary Disease.~   "
124616|NCT01424514|"~     The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score~     (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of~     intranasal, repeat dose SB-705498 in non-allergic rhinitis (NAR) patients elicited by a cold~     dry air challenge in an environmental exposure chamber (EEC). SB-705498 is a selective~     antagonist of the transient receptor potential vanilloid-1 (TRPV1) ligand gated ion channel.~     TRPV1 is a cation permeable ion channel that can be activated by several physiological~     factors, such as heat, protons (pH), osmotic stress, eicosanoid derivatives, anandamide, and~     by products of inflammation, such as histamine, prostaglandins and bradykinin. In the nose,~     the local TRPV1 expressing sensory C-fibres are thought to play a key role in the~     development of nasal hyper-responsiveness to environmental provocateurs. It has been~     proposed that blocking the nasal sensory nerve stimulation may control nasal~     hyper-responsiveness and therefore prevent the induction of rhinitis symptoms. In this~     context, preclinical evidence supports that targeting TRPV1 by SB-705498 may be an~     attractive option.~      In this study NAR patients will be randomised, in a double blind, placebo controlled cross~     over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily. Whilst~     dosing at home, subjects will record symptom scores to document their symptoms. In addition,~     during visits to the clinical unit, acoustic rhinometry, quality of life questionnaires and~     safety assessments will be monitored.~   "
124630|NCT01424332|"~     The primary objective of this study is to evaluate whether ASA and darexaban which have~     different effects on blood coagulation influence each other in their effects. Also it will~     be investigated whether the blood levels of either drug are influenced by the presence of~     the other drug. In addition, the safety and tolerability of each drug and the combination of~     the drugs will be investigated.~   "
124617|NCT01424501|"~     This study will assess the safety and immunogenicity of GSK Biologicals' investigational~     tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months~     to human immunodeficiency virus (HIV) negative adults who have received treatment for TB~     disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease~     (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB~     disease (denoted TB-naïve cohort) will also be enrolled.~   "
124618|NCT01424488|"~     Primary objectives:~        1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at~          reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in~          subjects undergoing abdominal surgery under general anesthesia~        2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex~          administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular~          blockade~      Secondary objectives:~      1. to evaluate the time from the start of sugammadex or placebo administration to the time~     of extubation and to the time of recovery of TOF ratio to ≥ 0.9~      Exploratory objectives:~        1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay~          after the end of surgery in subjects with pipecuronium induced neuromuscular blockade~          reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline)~        2. compare the number of patients extubated in the OR after the reversal by sugammadex or~          placebo, evaluate the TOF ratio at the time of extubation~      Clinical hypothesis:~      1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced~     blockade~   "
124619|NCT01424475|"~     The Leucine-Rich Repeat Kinase 2 (LRRK2) is implicated in autosomal dominant Parkinson's~     disease (PKD). An inhibitor for the leucine-rich repeat kinase 2 (LRRK2) is in pre-clinical~     development for potential use in treating Parkinson's disease. Patients with PKD have~     cognitive impairments which develop alongside the typical motor symptoms but a full~     characterisation of the neurocognitive phenotype of PKD patients with LRRK2 mutation is~     currently lacking. This observational study conducted on a single visit will assess the~     phenotypic neurocognitive abnormalities of PKD patients with the LRRK2 mutation with the aim~     of identifying potential PD endpoints related to the LRRK2 mutation for future Phase I or II~     clinical trials of LRRK2 inhibitors.~   "
124620|NCT01424462|"~     This study will investigate how 3 new types of drug formulations are absorbed by the body.~     This study is termed 'open-label', which means volunteers will be aware of which treatment~     they are receiving. The study involves all volunteers receiving all 3 different~     formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient)~     in this study. Volunteers will also receive a single dose of a formulation used in previous~     trials (reference formulation), so as a proper comparison with the new formulations can be~     made. One of the new formulations will also be administered along with food, to assess if~     the drug performs or is absorbed differently.~   "
124621|NCT01424449|"~     This will be an open label, non-randomised [11C]PHNO PET study using healthy male~     volunteers. Each volunteer will undergo 4 [11C]PHNO PET scans to allow for further~     characterisation of this radioligand and examine the effects of [11C]PHNO mass carry-over~     and displaceable binding in the brain. This study aims to obtain data from 6 evaluable~     subjects.~   "
124622|NCT01424436|"~     Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild~     Alzheimer's disease or mild cognitive impairment~   "
124623|NCT01424423|"~     The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein~     that prevents nerve growth.~      The trial is expected to involve approximately 36 patients. The study objective is to~     investigate the tolerability, safety and the way the body handles GSK1223249 after a range~     of single doses in patients with Multiple Sclerosis (MS).~   "
124624|NCT01424410|"~     Objective and Hypotheses: This project has the overall objective of implementing and~     evaluating new approaches to reducing the current and future burden of urinary~     schistosomiasis in young children using the antihelminthic drug praziquantel. The~     investigators hypotheses are that (1) praziquantel treatment will be as effective in~     children 1 to 5 years of age (who are routinely excluded from schistosomiasis control~     programmes) as it is in older 6-10 year old children and (2) two treatments will be more~     effective than a single treatment, especially in children 1 to 5 years of age.~   "
124625|NCT01424397|"~     This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms~     induced by an allergen chamber challenge.~   "
124626|NCT01424384|"~     This will be a phase I, single centre, randomised, double blind, double-dummy, placebo~     controlled, parallel group single-dose study in healthy volunteers. The purpose of this~     study is to assess the effect of a single-dose administration of GSK424887, a potent,~     selective competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent~     inhibitor of the human serotonin transporter (SERT), at the maximum dosage of 100 mg versus~     placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers.~     Pharmacokinetics and safety following oral administration of GSK424887 will be also~     evaluated. An Emotional Test Battery (ETB) previously used to characterise the effects of~     antidepressants on positive and negative emotion processing in Healthy Volunteers and~     patients will be used. We hypothesise that GSK424887 will modulate emotional information~     processing acutely. We anticipate that these effects may be manifest at sub-effective levels~     of NK1 and SERT receptor occupancy, thus providing pharmacodynamic evidence of the~     synergistic interaction of the two mechanisms in humans.~   "
124627|NCT01424371|"~     This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the~     elderly will produce greater vaccine effectiveness in their group.~   "
124628|NCT01424358|"~     Objective:~      The experimental design is a one-site, randomized experimental web-based educational~     feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the~     intervention group and approximately 50% PCPs on the control group, giving a total of 159~     participants. All 159 participants have willingly provided their e-mail addresses, as part~     of a survey they previously completed entitled, Survey of Health Professionals on Oral~     Cancer in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer.~   "
124629|NCT01424345|"~     The purpose of this study is to demonstrate whether there are any outcome benefits of a~     serial ImmuKnow assays in the management of de novo renal transplant recipients.~   "
124631|NCT01424319|"~     Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The~     objective of the study is to evaluate the efficacy and safety of once daily administration~     of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type~     2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose~     for hypertension of a RAS (renin angiotensin system) inhibitor.~   "
124632|NCT01424306|"~     People with chronic low-grade inflammation have a higher risk for certain diseases such as~     cardiovascular disease or type 2 diabetes. While it is known that obese people are more~     likely to show signs of low-grade inflammation than lean individuals, it is unclear what~     causes this inflammation. In the proposed study, the investigators will examine whether the~     sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in~     healthy men and women compared with other caloric sweeteners.~   "
124633|NCT01424293|"~     Bowel removal is indicated for various types of colon and rectal disease, including colon~     cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.~      Following removal of the diseased segment of bowel your surgeon will reconnect the two~     healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an~     extremely dangerous situation.~      The cause of leakage has many causes and is not well understood, but appears to be at least~     in part due to not having enough blood going to the bowel. There is currently no way to~     evaluate the blood supply to the bowel.~      The purpose of this study is to utilize a special camera to evaluate the blood supply of the~     bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing~     the occurrence of leaks~   "
124634|NCT01424280|"~     The purpose of this study is to assess bronchodilator effect after single dose~     administration of GSK1440115 in a population of mild to moderate asthmatic patients.~   "
124635|NCT01424267|"~     A registry to collect additional prospective intra-operative and follow-up information on~     physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA)~     Endovascular Graft under routine clinical care.~   "
124636|NCT01424254|"~     The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in~     patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.~   "
124637|NCT01424241|"~     This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1)~     normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical~     metabolic, cardiovascular and body composition parameters in patients with active~     acromegaly.~   "
124638|NCT01424228|"~     The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride~     versus placebo in subjects aged 18 years and older with chronic constipation.~   "
124639|NCT01424215|"~     The purpose of this study is to evaluate whether a fluorescent die and a special infrared~     camera can assist with the identification of the important structures during laparoscopic~     cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in~     less time and in a safer fashion than standard laparoscopic cholecystectomy.~   "
124640|NCT01424202|"~     Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the~     incidence of re-intubation and ICU length of stay. However, the role of NIV in~     post-extubation failure is still not clear. Impaired airway clearance is associated with NIV~     failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that~     has been proven to be very effective in patients under NIV.~      In this study the investigators assess the efficacy of MI-E as part of a protocol for~     patients that develop respiratory failure after extubation.~   "
124641|NCT01424176|"~     This is a multicenter, open-label, single-dose, PK and safety study in subjects with various~     stages of renal impairment.~   "
124642|NCT01424163|"~     This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK),~     safety, and tolerability of dexpramipexole administered orally to adult Japanese and~     Caucasian healthy subjects.~   "
124643|NCT01424150|"~     The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or~     crystalloid) for patients undergoing major surgery are based on rationales that are not~     supported by strong evidence. Practices vary substantially, guidelines are vague, small~     trials and meta-analyses are contradictory. The strongest and most consistent evidence, and~     biological plausibility because of tissue edema, supports a restrictive fluid strategy. But~     other evidence supports goal-directed therapy, requiring additional IV fluid. There is no~     good evidence that use and choice of colloids improves outcome. RELIEF will study the~     effects of fluid restriction, and the possible effect-modification of goal-directed therapy~     and colloids. The first will be randomly assigned; the latter will be measured covariates~     dictated by local practices and beliefs.~      Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery~     leads to reduced complications and improved disability-free survival when compared with a~     liberal fluid regimen.~      Secondary hypothesis: The effects of fluid restriction are similar whether or not~     goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive~     fluid regimen will reduce a composite of 30-day septic complications and mortality.~   "
124644|NCT01424137|"~     The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler®~     (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children,~     adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).~   "
124645|NCT01424124|"~     The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to~     singulair or placebo in patients (n=96) with partially controlled asthma.~      The study will conduct with 4 comparative groups orally treated with YHD001 dose level~     1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.~   "
124646|NCT01424111|"~     The purpose of this research is to explore objective biomarkers in voice, physiological,~     motor, and brain imaging signals that may one day be used to complement clinical evaluation~     and treatment of depression.~   "
124647|NCT01424098|"~     A growing body of evidence suggests that individuals with chronic lung disease have~     important deficits in balance control that may be associated with an increased risk of~     falls. The main purpose of this study is to examine the effects of a balance training~     program on measures of balance and fall risk in people with chronic lung disease.~   "
124648|NCT01424085|"~     The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before~     percutaneous gastrostomy performed in interventional radiology. Patient will be randomized~     to receive antibiotics or placebo before the procedure, and the rates of skin infection~     after the procedure will be determined between the two groups. This has never been studied~     in our population of patients undergoing the procedure. However, antibiotics are routinely~     given despite the lack of evidence. The investigators hypothesize that patient receiving~     prophylactic antibiotics will have a decreased number of infections compared to placebo.~   "
124649|NCT01424072|"~     This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies~     in 75 nursing professionals in a University Hospital.~   "
124650|NCT01424059|"~     The purpose of this study is to evaluate the experience of labor in parous women induced~     because of fear of labor and, to compare the experience of parous women induced without fear~     of labor. A comparison with the experience of women delivered with elective cesarean section~     because of fear of labor is done.~      In the induced labors, the induction method is amniotomy. Between groups the experience of~     delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).~      Groups are also compared with regard to time from induction to delivery and rate of~     operative delivery.~      Hypotheses:~        -  there is no difference in experience of delivery~        -  there is no difference in time to delivery or rate of operative deliveries~   "
124651|NCT01424046|"~     This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the~     effectiveness of a basal approach to diabetes management as compared to the current standard~     treatment (regular/NPH).~      Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to~     participate in the study and consent will be obtained by the investigation team. This will~     continue until 40 patients have been enrolled at which time recruitment will be started at a~     provincial hospital, at which 10 further participants will be recruited. Participants will~     be consenting to 1) Randomization to basal or current insulin treatment arm and 2)~     Permission for use of clinical data for research.Participants will be followed every six~     months for a period of 24 months. The first 6 months will be a wash in period and~     participants will be randomised (1/1) to their treatments at the 6 month visit.~   "
124652|NCT01424033|"~     The first objective of this protocol is to assess the tolerability and safety of~     N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung~     disease (CTD-ILD).~   "
124653|NCT01424020|"~     The purpose of this study is to test and validate a new questionnaire in order to get a~     walking estimated limitation calculated by history (WELCH) in patients referred for~     vascular investigations.~   "
124654|NCT01424007|"~     The purpose of the MENU Study is to examine whether there is a differential weight loss~     response to different dietary macronutrient composition (higher carbohydrate and lower fat~     versus lower carbohydrate and higher monounsaturated fat [MUFA] or lower carbohydrate and~     walnut-rich higher fat diets) in a weight loss intervention in healthy obese women,~     depending on insulin resistance status. Blood samples will be collected to enable analysis~     of potential mechanisms and differential response across subgroups.~   "
124655|NCT01423994|"~     Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits,~     and probably is responsible for CDN $250 million in health care spending each year. It is~     associated with decreased quality of life, trauma, loss of employment, and limitations in~     daily activities. It is a particular problem for older people, partly because of increased~     frailty, and partly because of a difficult differential diagnosis. One of the causes in~     older adults is intermittent complete heart block in the setting of bifascicular heart~     block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome,~     and several neurally mediated syncopes. Often treatment decisions should be made before the~     true cause is apparent.~   "
124656|NCT01423981|"~     This trial intends to gather very basic clinical information about keloid, its patterns of~     presentation, family history, ethnic background and correlation with the type of keloid, as~     well as prior treatment results that patients have had received.~   "
124657|NCT01423968|"~     The investigators aim to examine how the skeletal muscles of the human volunteers respond to~     experimental septic conditions to aid understanding of muscle wasting and its biology..~      Six healthy men aged 18-30 will be randomly assigned to two metabolic study visits. On the~     first visit, while resting on a bed, they will have four cannulae inserted including one in~     the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and~     tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will~     receive either injection of purified bacterial product called lipopolysaccharide (LPS) to~     induce flu-like symptoms or normal saline according to randomization followed by a metabolic~     test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will~     be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By~     performing these measurements, the investigators will determine the consequences of LPS on~     muscle production and carbohydrate metabolism.~   "
124658|NCT01423955|"~     The purpose of this study is to evaluate the potential of erythropoietin in reducing risk~     and degree of acute kidney injury after cardiac surgery.~   "
124659|NCT01423942|"~     The purpose of this study is to try to evaluate the maturation of the autonomic nervous~     system in prematures.~   "
124660|NCT01423929|"~     The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and~     during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction~     (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2~     treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI.~     Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to~     assess infarct size and myocardial performance. All patients are followed for 6 months. At 6~     months, perceived health and NT-proBNP are recorded for all patients, and an additional~     echocardiography is performed. The primary endpoint is the fraction of myocardium saved with~     the acute PCI. The secondary endpoints include the pain difference between inclusion time~     and start of PCI and myocardial performance on echocardiography.~   "
124683|NCT01423630|"~     Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.~      The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial~     composition in a positive manner. The improved ecological system is believed to contribute~     to improved liver health and thereby counteract fatty liver disease.~   "
124661|NCT01423916|"~     The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and~     adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective~     subjects. The goals of this trial are three-fold:~        -  To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for~          placebo~        -  To determine the effect of moxifloxacin on QTcI~        -  To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI~   "
124662|NCT01423903|"~     The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given~     daily by mouth to subjects with advanced solid tumors.~   "
124663|NCT01423890|"~     A prospective population-based cohort study is being conducted in Ontario to evaluate~     whether the performance of Oncotype DX® changes the treatment recommended and the treatment~     received in women or men with node negative, ER positive breast cancer who are receiving (or~     will receive) endocrine therapy and who are candidates for chemotherapy. One thousand~     eligible consenting women and men will have their tumor tissue specimen sent to Genomic~     Health where the Oncotype DX® assay will be performed.~   "
124664|NCT01423877|"~     Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus~     intensive medical weight management on indices of insulin resistance and resolution of type~     2 diabetes among patients with BMI 30-35.~      Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission~     in obese diabetic patients BMI 30-35.~      The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin~     resistance after either bariatric surgery or initiation of intensive medical weight~     management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose~     <200mg/dL two hours after a standard 75g oral glucose load without the use of~     anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at~     6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on~     insulin and fasting glucose, as well as oral glucose tolerance tests with~     area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will~     be derived from electronic health records and patient self-report at 6 months. Secondary~     outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and~     levels of fasting lipids.~   "
124665|NCT01423864|"~     Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction~     syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such~     as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed~     to treat the severe condition. In this study, the investigators report patients who~     responded to intrapleural steroid instillation (IPSI) while being unresponsive to~     conventional treatment (use of intravenous steroids, nitric oxide inhalation, high-frequency~     oscillatory ventilation, or ECMO) for treatment of critical illnesses such as ARDS in~     combination with MODS.~   "
124666|NCT01423851|"~     The purpose of this study is to determine the safety and tolerability of orally administered~     NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis~     (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)~   "
124667|NCT01423838|"~     Null hypothesis of the trial is that there is no difference between solifenacin and~     oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life~     measures in patients with overactive bladder.~   "
124668|NCT01423825|"~     This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety~     and immune response to an HIV envelope protein vaccine boost in people who have previously~     received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102~     study.~   "
124669|NCT01423812|"~     Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that~     evolved from a prototype compound synthesized using structure-based design strategies.~     Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral~     agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced~     patients, darunavir was initially approved for twice-daily administration boosted with~     twice-daily ritonavir at 600mg and 100mg, respectively. Recently, once-daily~     darunavir/ritonavir was approved for use in treatment-experienced adult patients with~     viremia with no darunavir resistance mutations. In treatment-experienced patients with viral~     suppression, switching from an antiretroviral taken twice-daily to a once-daily dose is an~     attractive option to promote greater patient acceptability and adherence, and potentially~     minimize side effects and toxicities. Because of darunavir/ritonavir's high genetic barrier~     to resistance and well-established safety profile at a once-daily dose, switching patients~     with virologic suppression from twice-daily darunavir/ritonavir to once-daily~     darunavir/ritonavir will likely confer attributes more favorable to patients through a~     simplified dosing schedule and lower potential for lipid elevation without the loss of~     virologic control. DRIVESHAFT is a 48-week Phase 4, randomized, open label, comparative~     study. The study will be conducted in 60 HIV-1 infected, antiretroviral experienced,~     virologically-suppressed patients on regimens containing darunavir 600mg/ ritonavir 100mg~     twice-daily and a minimum of two other antiretrovirals, with a history of 0-1~     darunavir-associated resistance mutations. Subjects will be randomized 1:1 to switch to~     darunavir 800mg/ ritonavir 100mg once-daily or continue on their current regimen. Rates of~     virologic suppression of once-daily darunavir/ritonavir regimens relative to~     darunavir/ritonavir twice-daily regimens will be compared, and safety, change from baseline~     fasting lipid parameters, and adherence will be evaluated.~   "
124670|NCT01423799|"~     The purpose of this study is to compare the health-related quality of life following dietary~     supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet~     supplement in patients suffering from upper digestive tract neoplasia undergoing oncological~     treatment.~   "
124671|NCT01423786|"~     This is a prospective trial for children with the diagnosis of mild acute pancreatitis~     admitted to the hospital for continued management. Patients will be enrolled in the study~     within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled.~     Demographic, laboratory and imaging data done as standard of care will be collected and~     additional blood work will be sent as part of the study. Patients will be followed~     prospectively with regards to tolerance to oral nutrition, pain, length of stay and~     complications. The hypothesis is that patients that are able to tolerate early oral~     nutrition will have shorter length of stays and will be similar in terms of pain score~     ratings, readmission rates, complications and the need for invasive supplemental nutrition.~     Also patients that are able to tolerate early oral nutrition will have less significant~     elevation of biochemical markers of pancreatitis severity when compared to patients that do~     not tolerate early oral nutrition and historical controls.~   "
124672|NCT01423773|"~     The purpose of this study was to compare the fit and comfort of two types of contact lenses.~   "
124684|NCT01423617|"~     The intention of the study is to evaluate the safety and potential body weight and body fat~     loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind,~     placebo-controlled, parallel study conducted in Caucasian subjects.~      This study will also include a diet plan for each subject, calculated based on gender, age,~     and energy requirements; and adjusted to be slightly hypocaloric.~   "
124673|NCT01423760|"~     This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA,~     EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in~     this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25).~     Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006~     [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received~     tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this~     follow-up trial and have safety assessments performed as well as were observed for~     progressive disease (PD) and survival in 6- month intervals. Subjects who had not received~     tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD~     and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).~   "
124674|NCT01423747|"~     With this protocol the ALL-SZT BFM international study group wants~      to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or~     unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).~      to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched~     family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor~     (MSD) and matched donor (MD).~      to determine whether therapy has been carried out according to the main haematopoietic stem~     cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment~     options during haematopoietic stem cell transplantation (HSCT) from different donor types~     aims at the achievement of an optimal comparison of survival after HSCT with survival after~     chemotherapy only.~      to prospectively evaluate and compare the incidence of acute and chronic graft-~     versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from~     matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).~   "
124675|NCT01423734|"~     Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used~     to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue~     with the same treatment. On the other hand, growing tumors in a patient can bring about a~     change in therapy. Unfortunately, it often takes three to six months, or even longer before~     the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging~     tools that can look at how tumors respond early on during treatment. This study will help us~     decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a~     helpful imaging tool.~   "
124676|NCT01423721|"~     The objective of the current study is to investigate relative bioavailability of bromhexine~     hydrochloride given as granules and syrup~   "
124677|NCT01423708|"~     Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.~   "
124678|NCT01423695|"~     The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment~     of advanced breast cancer based on a large pivotal study. However, mono and combination~     chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index,~     especially in the palliative setting. The present trial examines the efficacy and safety of~     weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+~     patients.~   "
124679|NCT01423682|"~     Patients with rotator cuff tendinopathy make up a large part of the population in~     physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role~     in causing pain. Tendons suffer large compression and friction, which can lead to~     degeneration of these tendons. Rehabilitation often leads to unsatisfying results.~      In Achilles and patella tendinopathy, a new training program called eccentric training has~     shown very good results. Eccentric training contains exercises during which a force has to~     be resisted while the muscle lengthens instead of shortens. This would have a larger~     influence on tendon tissue. Some small studies also show promising results of eccentric~     training in patients with rotator cuff tendinopathy but the mechanisms behind these results~     remain unclear.~      To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will~     be evaluated before and immediately after performing the exercise. Three measurements will~     be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and~     measurement of microcirculation around the tendon with Oxygen to see. All measurements are~     non-invasive, pain free and without risks for the human body.~   "
124680|NCT01423669|"~     Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders~     influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors.~     Despite significant progresses in pharmacotherapy, the disorder often results in long-term~     disability (ranked globally amongst the top ten leading causes of disability-adjusted life~     years, DALYS), often associated with extensive cost, burden, morbidity and mortality.~      Objective / hypothesis The study aims to (1) measure the prevalence of psychotic symptoms in~     the Hong Kong population; (2) explore associated risk and protective factors for the~     expression of psychotic symptoms; (3) characterize the functional disability in people with~     psychotic symptoms; and (4) study the determinant of clinical presentation or~     non-presentation in people with psychotic symptoms.~      Design, subjects and study instrument The survey will be conducted with a two-phase design.~     The first phase interviews will include approximately 5,000 subjects with structured~     assessments serving diagnostic criteria for CMD, screening instruments for psychotic~     disorder, substance misuse and suicidal behaviours, functioning, service use and~     demographics. The second phase comprises of clinician interviews for psychotic disorder and~     at risk mental state and other variables including neurocognitive, help seeking, stigma~     and well-being.~      Analysis Prevalence estimates will be weighted, expressed as rates and confidence intervals.~     Comorbidity will be estimated using Latent Class Analysis (LCA) Logistic regression will be~     used to identify significant factors associated with mental disorders.~   "
124681|NCT01423656|"~     The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data~     when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.~      The study is divided into one single dose part, one part to compare pharmacokinetics between~     gender and one multiple dose part.~   "
124682|NCT01423643|"~     The chief purpose of this research is to understand how antiretroviral therapy (ART) affects~     progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV).~     The investigators study liver disease progression in a cohort of dually infected persons~     according to the success of ART.~   "
124685|NCT01423604|"~     The purpose of this study was to determine whether ruxolitinib added to capecitabine is~     effective in improving the overall survival of patients with metastatic pancreatic cancer.~   "
124686|NCT01423591|"~     Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown~     origin which predominantly develops in elderly subjects and presents with severe pain and~     stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase~     reactants. Systemic manifestations such as fever, anorexia and weight loss are~     characteristic signatures of PMR.~      Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the~     symptoms of the disease disappear after one or two years of treatment, a proportion of~     patients remain CS-dependent with the subsequent CS toxicity. Open label studies have~     suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS~     sparing effect in patients with refractory PMR.~      The investigators conducted a randomised, double-blind, placebo controlled trial with~     infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as~     requiring ≥ 5 mg/day after at least 2 years of treatment to maintain remission or ≥ 7.5~     mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v)~     at 0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced~     according to a predefined schedule. The primary outcome was the proportion of responder~     patients -defined as individuals with both complete clinical and analytical remission~     without receiving CS for at least three months- at 24 weeks. Secondary outcomes were~     cumulative CS doses and adverse events proportion.~   "
124687|NCT01423578|"~     The overall purpose of this pilot study is to examine effects of Hatha yoga and~     cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our~     preliminary study indicated that a single session of either form of activity intervention~     improved mood, and the yoga intervention appeared to decrease cravings to smoke. The~     proposed study will extend this preliminary research in several ways.~   "
124688|NCT01423565|"~     HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable~     control of Parkinson's disease symptoms than constant voltage stimulation.~      Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for~     advanced Parkinson's disease (PD). Two types of implantable pulse generators (IPGs) are~     available, differing on whether voltage or electrical current is controlled. Constant~     current IPGs provide a specific electrical current and will automatically adjust the voltage~     depending on the impedance, while the current applied by constant voltage IPGs will depend~     on the tissue impedance that may change over time. No study has compared the clinical~     differences of these two electronic modalities.~   "
124689|NCT01423552|"~     The ongoing success of transplantation is largely due to the development of drugs to stop~     the patient's body from rejecting the new organ. In addition to steroids, two main types of~     drug are used to suppress the immune system following heart transplantation: calcineurin~     inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients~     respond in different ways to these drugs, with the same dose leading to different levels of~     the drug in the blood. This varies due to genetic and other factors such as age, kidney~     function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the~     blood are routinely measured and the dose adjusted accordingly. However, some patients still~     experience episodes of rejection despite apparently acceptable levels. In this study, the~     investigators will measure levels of the drugs (in the blood, in a type of white blood cell~     called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The~     investigators will compare these levels with patient genetic factors and the amount of~     rejection measured on heart biopsies. This will enable us to better understand how the blood~     and tissue levels of these drugs change with genetic and other factors in order to optimise~     immunosuppressive therapy and further improve outcomes from heart transplantation.~   "
124690|NCT01423539|"~     This randomized, open-label, multicenter study will evaluate the efficacy and safety of~     navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large~     B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to~     bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.~   "
124691|NCT01423526|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.~   "
124692|NCT01423513|"~     The purpose of this study is to examine the effects of ankle taping on improving muscle~     function and ankle motion in individuals who frequently twist (sprain) their ankle. It is~     thought that ankle taping may increase muscle function and ankle motion which would benefit~     individuals who frequently sprain their ankle.~   "
124693|NCT01423500|"~     With this protocol the ALL-SCT BFM international study group wants~        -  to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family~          or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).~        -  to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from~          mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling~          donors or matched donors.~        -  to determine whether therapy has been carried out according to the main HSCT protocol~          recommendations. The standardisation of the treatment options during HSCT from~          different donor types aims at the achievement of an optimal comparison of survival~          after HSCT with survival after chemotherapy only.~        -  to prospectively evaluate and compare the incidence of acute and chronic~          Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from~          matched donor (MD) and from mismatched donor (MMD).~   "
124694|NCT01423487|"~     Some previous studies has demonstrated that Metformin can improve the weight gain which~     caused by antipsychotics. An our study, which will be published, also found that Metformin~     can improve the amenorrhea for patients with antipsychotics, approximately 60% patients~     recovery period. So the present study was designed to investigate the efficacy and safety of~     Metformin in preventing patients with Risperidone from weight gain and amenorrhea.~   "
124695|NCT01423474|"~     The purpose of this study is to compare the toxicity of two new radiation schedules for the~     treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered~     every other day over 11 days, or once per week over 29 days. Both of these schedules are~     shorter than the standard treatment which is usually 39 treatments over 8 weeks.~   "
124732|NCT01422993|"~     The purpose of this study is to evaluate the effects on strength, balance, and neuropathic~     symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group~     exercise program designed to improve lower extremity strength and balance with persons with~     oxaliplatin induced peripheral neuropathy.~   "
124696|NCT01423461|"~     Individualized health care refers to the development of strategies for disease management~     and health promotion that are informed by specific data on genetics and physiological~     processes that uniquely determine each person's health profile and potential responsiveness~     to interventions or susceptibility to environmental exposures.~      Asthma, an inflammatory disorder of the airway, appears to be determined by multiple~     interacting genetic and environmental factors. Such risk factors include allergic responses,~     small airways, excess body weight, specific properties of airway smooth muscle, airway and~     generalized metabolic and inflammatory homeostasis, and exposures to environmental~     irritants, allergens, and psychosocial stressors. To date, asthma treatment strategies have~     been guided by severity guidelines rather than by characteristics of the child's specific~     phenotype (a child's underlying allergic tendency, extent of airway inflammation and airway~     smooth muscle dysfunction, or underlying obesity and metabolic perturbations). The growing~     availability of new classes of asthma medications that more directly target specific~     pathophysiological derangements will require accessing data on each child's asthma risk~     profiles to optimize selection of medications and other interventions that most specifically~     address the underlying pathophysiology while minimizing adverse treatment side effects.~      The investigators propose to develop a model program for collecting relevant clinical~     information and genetic data on a high risk group of asthmatic children, including data on~     common co-morbidities, specifically obesity and sleep disorders; use this information to~     develop a comprehensive model database for characterizing children according to their health~     profiles; and use this characterization to initiate targeted interventions, while continuing~     long term follow up of these children to determine differential responsiveness to~     medications.~   "
124697|NCT01423448|"~     This study is a randomised controlled trial that aims to examine the efficacy of an~     established online bulletin board for depression. It has been estimated that millions of~     people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs)~     for health conditions. However, little is known about the effectiveness of these groups in~     terms of symptom reduction or improvement in quality of life. The current project~     investigates the effectiveness of an established online bulletin board for depression~     available to the public. To our knowledge, this is the first randomised controlled trial of~     the effectiveness of a pre-existing, well-established online bulletin board for depression~     in the community. The aims of the project are to determine whether the bulletin board~     improves mental health, quality of life, and related outcomes among members of the community~     with high levels of self-reported psychological distress and previous history or current~     experience of depression.~   "
124698|NCT01423435|"~     A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and~     South Korean non-elderly healthy adult males.~   "
124699|NCT01423422|"~     The investigators have previously shown that a frequency of 15.95-16.00 Hz protects against~     acute myocardial infarction in rats. In the current study the investigators would like to~     investigate whether this frequency enables cardiac patients with exercise-induced chest pain~     to exercise at higher workload and heart rate. Therefore, patients will undergo two exercise~     stress tests, one test after being exposed to 30 minutes of the above mentioned frequency~     and another test after being exposed to sham (no frequency is turned ON). The investigators~     will measure changes in the electrocardiogram (ECG), workload, exercise time, and subjective~     measure of chest pain (angina).~   "
124700|NCT01423409|"~     The purpose of this study is to assess an innovative Visual Analogue Scale of pain~     (pictorial VAS) versus the usual VAS (VAS) among Deaf People.~      The assumption of this study is that pictorial VAS is more suited to Deaf people than usual~     VAS.~   "
124701|NCT01423396|"~     Three quarters of patients with Alzheimer's disease have at least one vascular risk factor~     (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older~     ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease.~     Many research studies have shown that VRFs are also risk factors for Alzheimer's disease;~     this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser~     extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE)~     have indicated that antihypertensive medications can prevent the appearance of dementia (and~     notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233~     Alzheimer's patients with an average follow-up period of 4 years has shown that the annual~     decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all~     the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5~     points versus 2.5 ± 2 points, respectively; p<0.04).1 However, it is not currently known~     whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's~     disease. Answering this question could have a significant impact on public health.~   "
124702|NCT01423383|"~     Although keloid is a very common condition; there are no statistics as to its true incidence~     and prevalence, neither in United States, nor elsewhere in the world. This trial intends to~     capture epidemiological data about this disease in a large population sample.~   "
124703|NCT01423370|"~     The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g~     on erectile dysfunction to investigate the optimal recommended dosage. Study period is 12~     weeks including 4weeks of follow-up period without treatment. Study patients will fill in~     the international index of erectile function questionnaire and life satisfaction~     questionnaires.~   "
124704|NCT01423357|"~     The aim of this study is to investigate whether distribution of condoms and condom~     demonstrations by youth peer educators in venues where people meet new sexual partners in~     Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.~   "
124705|NCT01423344|"~     Background: in patients with multiple myeloma there is a raised level of a protein, named~     M-protein. This M-protein is normally used to monitor disease status and evaluate response~     to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy.~     However, the M-protein has a long half life in serum, approximately three weeks, which tend~     to be a practical problem, since the investigators can first determine hereafter if the~     treatment is effective.~      A new assay has the possibility only to measure part of this protein, namely the light~     chains, which also is measured in a blood sample. The half life of these light chains is~     much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of~     a given treatment, thereby being able to determine earlier if the treatment should continue~     or changed to another strategy.~      Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum~     free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under~     treatment for multiple myeloma.~      Method: the investigators measure sFLC in patients receiving there 1st treatment, either at~     the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and~     the results are compared to the M-protein.~   "
124733|NCT01422980|"~     The purpose of this study is to determine whether the consumption of test dairy products is~     effective in reducing upper gastric discomfort after 2 weeks of product consumption.~   "
124706|NCT01423331|"~     An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the~     Shin Kong Wu Ho-Su Memorial Hospital~      - Objectives：~        1. To construct a screening tool for domestic maternal mental health~        2. To expect to find the screening timing for early assessment or intervention of domestic~          maternal mental health status.~        3. To explore the impact of domestic maternal mental health factors.~   "
124707|NCT01423318|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers.~     Healthy Japanese and Caucasian volunteers will be randomized to receive a single~     subcutaneous dose of either lebrikizumab or placebo.~   "
124708|NCT01423305|"~     The objective of the study is to assess if charcoal prevents the absorption of budesonide~     and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic~     parameter area under the concentration-time curve.~   "
124709|NCT01423292|"~     The purpose of this study is to determine whether the transversus abdominis plane (TAP)~     blocks are effective in postoperative pain control of adult patients undergoing laparoscopic~     colectomy.~   "
124710|NCT01423279|"~     This research is NOT part of an interventional trial, however the investigators use~     umbilical cord after birth for isolating endothelial and smooth muscle cells for academic~     research.~   "
124711|NCT01423266|"~     This research project was designed to study the role of dietary modifications in heart~     failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically,~     the purpose of this study is to determine whether or not heart failure patients~     participating in a 3-month intensive lifestyle modification program of either a high protein~     (30 % of total calories from protein) group will have a significant improvement in weight~     reduction, quality of life and clinical outcomes compared to a standardized protein (15% of~     total calories from protein) group.~   "
124712|NCT01423253|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features over time.~   "
124713|NCT01423240|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features.~   "
124714|NCT01423227|"~     Pulmonary rehabilitation is an effective treatment for people with chronic obstructive~     pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers~     healthcare costs. However less than 1% of Australians with COPD receive pulmonary~     rehabilitation each year, due to poor access to programs and high levels of disability. This~     randomised controlled trial will examine the benefits and costs of a novel, entirely~     home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based~     pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the~     centre-based program.~      We will randomly allocate 144 people with COPD to undertake either standard pulmonary~     rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake~     pulmonary rehabilitation in the hospital setting will attend the hospital twice each week~     for eight weeks for supervised exercise training and education. People in the home pulmonary~     rehabilitation group will receive one home visit and weekly telephone calls for eight weeks,~     for supervision and mentoring of exercise and provision of education. We will compare the~     number of people who complete the program in each setting. We will also test whether the~     groups have similar results for the standard pulmonary rehabilitation outcomes of~     breathlessness, quality of life and exercise capacity, at the end of the program and 12~     months later. We will compare health care costs and personal costs between groups after 12~     months.~      If home-based pulmonary rehabilitation can improve uptake of this important treatment,~     deliver good clinical outcomes and reduce costs this will have significant and long-lasting~     benefits for patients, the community and the health system~   "
124715|NCT01423214|"~     This study sets up the final study end point and three detailed goals as the following.~      The main objective of study: This trial is done to assess the safety and benefit of robotic~     resection compared with conventional laparoscopy-assisted resection for curative treatment~     of patients with cancer of the mid or low rectum.~      Detailed goal of study:~      The primary endpoint: This study is designed to assess whether robotic surgical system~     improves the quality of rectal cancer surgery, especially in total mesorectal excision~     quality and a circumferential margin positivity rate~      The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and~     overall survival after robot and laparoscopic resection of distal rectal cancer. This study~     will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological~     quality (i.e. number of harvested lymph node), local recurrence, and blood loss during~     surgery.~   "
124716|NCT01423201|"~     Transient ischemic attack (TIA) is a transient neurological deficit (speech disturbance,~     weakness…), caused by temporary occlusion of a brain vessel by a blood clot that leaves no~     lasting effect.~      TIA diagnosis can be challenging and an expert stroke evaluation combined with magnetic~     resonance imaging (MRI) could improve the diagnosis accuracy.~      The risk of a debilitating stroke can be as high as 5% during the first 72 hrs after TIA.~      TIA characteristics (duration, type of symptoms, age of the patient), the presence of a~     significant narrowing of the neck vessels responsible for the patient's symptoms~     (symptomatic stenosis), and an abnormal MRI are associated with an increased risk of stroke.~      An emergent evaluation and treatment of TIA patients by a stroke specialist could reduce the~     risk of stroke to 2%.~      Stanford has implemented an expedited triage pathway for TIA patients combining a clinical~     evaluation by a stroke neurologist, an acute MRI of the brain and the vessels and a sampling~     of biomarkers (Lp-PLA2). The investigators are investigating the yield of this unique~     approach to improve TIA diagnosis, prognosis and secondary stroke prevention. The objective~     of this prospective cohort study is to determine which factors will help the physician to~     confirm the diagnosis of TIA and to define the risk of stroke after a TIA.~   "
124717|NCT01423188|"~     This study is designed to provide an assessment of the change in baseline lipid parameters~     with RVX000222 after 12 weeks and 24 weeks of treatment when given in addition to optimized~     statin background therapy in subjects with low baseline HDL-C.~   "
124718|NCT01423175|"~     ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting~     of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed~     by reduced-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell~     transplantation (SCT). The aim of the study is to explore the antileukemic,~     immunosuppressive effects and toxicity and safety of clofarabine in combination with ara-C~     in the setting of RIC allogeneic transplantation compared with the FLAMSA-protocol for~     patients with high-risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome~     (MDS).~   "
124719|NCT01423162|"~     This study will follow a double blinded randomized controlled study design to enroll 20~     apparently healthy 6 year old children. The children will be fed with two different nutrient~     fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA).~     Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for~     stable isotope measurements and iron absorption will be calculated.~   "
124720|NCT01423149|"~     The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27,~     36 and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal~     neovascularization in subjects with pathologic myopia.~   "
124721|NCT01423136|"~     In moderate to high risk patients, cardiovascular complications after surgery account for~     almost 60% of death after surgery. This study will randomize 140 patients into routine~     postop care with Holter monitoring versus routine postop care + remote ST monitoring +~     Holter monitoring. The response time to electrocardiographic (ECG) ST changes as well as the~     total ischemia time will be studied.~   "
124722|NCT01423123|"~     The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study~     evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with~     metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the~     safety and tolerability of the three-drug combination.~   "
124723|NCT01423110|"~     This study will assess the efficacy, safety and tolerability of BYM338 in patients with~     sporadic Inclusion Body Myositis~   "
124724|NCT01423097|"~     Estimate the prevalence of self-reported osteoarthritis and its characterization in adults~     over 45 years of age:~        -  Characterization of self-reported patients with OA (socio-demographic, comorbidities,~          VAS for intensity of pain)~        -  Characterization of OA diagnosis in patients with self-reported OA~        -  Impact of self-reported OA in the working abilities, quality of life and functionality~          (SF-12 v2.0)~        -  Characterization of treatment approaches (therapeutic and non-therapeutic) for~          self-reported patients with OA~        -  Patient perception of impact of OA in its life and importance given to disease~   "
124725|NCT01423084|"~     The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1~     to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum~     bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis~     serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA~     geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days~     after a primary vaccination course of two doses administered one month apart.~   "
124726|NCT01423071|"~     The purpose of this study is to determine the prevalence of pulmonary hypertension (PH)~     among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the~     quality of life in those patients with concomitant PH compared to COPD patients without PH~     and those only suffering from pulmonary arterial hypertension (PAH) respectively.~   "
124727|NCT01423058|"~     The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential~     thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite~     of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN~     share a range of biological, pathological, and clinical features including the relative~     overproduction of one or more cells of myeloid origin, growth factor independent colony~     formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and~     hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005).~      This is a multi-centre, open-label, non-randomized, dose-escalation study, to be conducted~     in two phases: a dose-escalation phase (Part 1), to determine the safety and tolerability of~     momelotinib (CYT387), and to identify a therapeutic dose for the expanded cohort; and a~     dose-confirmation phase (Part 2), which will be a cohort expansion at or below the MTD of~     momelotinib.~      In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels~     in successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily~     with doses taken approximately 12 hours apart). Doses will be escalated by 50 mg BID per~     cohort until dose-limiting toxicities are observed. The dose level at which ≥2 of 6 subjects~     develop a first cycle dose-limiting toxicity (DLT) is defined as the DLT level. The maximum~     tolerated dose (MTD) is defined as the dose level below the DLT level. New dose levels may~     begin accrual only if all subjects at the current dose level have been observed for a~     minimum of 28 days from the first day of treatment. The dose level chosen for study in the~     dose confirmation phase of the study will be the MTD or a lower dose shown to have~     significant clinical activity (efficacy) as determined by the safety review committee.~     Subjects will be evaluated weekly for the first cycle, every 2 weeks during cycle 2, then~     monthly for 4 cycles for a total of 6 cycles.~      In the dose-confirmation phase of the study, approximately fifty (50) subjects will be~     treated at the MTD or at a lower dose shown to have significant clinical activity (efficacy)~     as chosen by the Safety Review Committee. In the dose confirmation phase of the study~     subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly~     for 5 cycles for a total of 6 cycles.~   "
124728|NCT01423045|"~     The study hypothesis is that urine concentrating ability can predict the rate of kidney~     function decline.~      Patients with kidney disease at the investigatorsclinic will be asked to give first morning~     urine sample and osmolarity will be measured. The investigators will follow up kidney~     function decline and check if there is association with urine osmolarity.~   "
124729|NCT01423032|"~     Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to~     its unique mechanism of action distinct from standard alkylating agents. This study assesses~     its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in~     comparison to fludarabine.~      Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous~     systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine~     100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of~     25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior~     progression-free survival with bendamustine.~   "
124730|NCT01423019|"~     The purpose of this study is to determine whether subjects taking a supplement designed to~     increase metabolic rate will have a positive effect on body composition (fat mass, muscle~     mass, and bone density.)~   "
124731|NCT01423006|"~     This is a prospective pilot study. The purpose of this research study is to evaluate the~     safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically~     localized prostate cancer.~   "
124734|NCT01422967|"~     Osteoarthritis (OA) is one of the major health problems and their prevalence has increased~     in recent decades. It has been shown that OA causes negative effects on sleep and that these~     changes in sleep see to be correlated with the function and physical performance of patients~     with OA. However, no study to date has demonstrated the effects of sleep changes in~     sensorimotor control and systemic inflammatory response in patients with OA. The objective~     of this study is to assess the influence of sleep changes in sensorimotor control (postural~     and neuromuscular control) and inflammatory markers (cytokines) in patients with knee OA~     grade I or II. Participate in this study, 60 male volunteers, aged between 40 and 65. These~     volunteers will be divided into four groups: Group 1 (n = 15): Osteoarthritis and good~     quality sleep, Group 2 (n = 15): Osteoarthritis and poor quality sleep, Group 3 (n = 15):~     Without good and Osteoarthritis quality of sleep, Group 4 (n = 15): Without Osteoarthritis~     and poor quality of sleep. All volunteers will perform a polysomnography to detect the~     presence or not of changes in sleep. Further testing on the isokinetic dynamometer to~     evaluate the acceleration time, maximum isometric torque and isokinetic concentric and~     eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular~     control. Also there will be a test on the force platform to assess the uni-and bipedal~     postural control, as well as respond to the WOMAC questionnaire that assesses the quality of~     life in patients with OA. Blood will be collected for analysis of inflammatory cytokines~     (TNF-alpha, IL-1alpha, IL-1beta, IL-6, IL-8, IL-12, IL-10, TGF-beta). The significance level~     is 5% (p ≤ 0.05).~   "
124735|NCT01422954|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life, significantly contributing to the ongoing poverty in endemic countries. It~     causes 800.000 deaths per year, the majority of which are children under the age of five.~     The malaria parasite enters the human body through the skin, by the bite of an infected~     mosquito. Subsequently, it invades the liver and develops and multiplies inside the~     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the~     blood stream, causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct controlled human malaria infections~     (CHMIs). CHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although~     potentially serious or even lethal, P. falciparum malaria can be radically cured at the~     earliest stages of blood infection when risks of complications are virtually absent.~      The investigators have shown previously that healthy human volunteers can be protected from~     a malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito~     bites) under chloroquine prophylaxis (CPS immunization). Interestingly, sterile protection~     in 100% of the human CPS immunized volunteers was achieved by a relatively miniscule dose,~     i.e. a total of 45 infectious mosquito bites, strikingly 20-fold more potent than the 1000~     bites needed in a model using irradiated mosquitoes. One possible explanation for this~     efficient induction of protective immunity, is the immune modulating effect of chloroquine.~     The investigators aim to assess this possible immune modulating effect in CPS immunization~     by comparing immunization with P. falciparum sporozoites under chloroquine with immunization~     under mefloquine prophylaxis, which has the same antimalarial effect, but not the immune~     modulating effects known from chloroquine.~   "
124736|NCT01422941|"~     The objectives of this clinical research project are to demonstrate the safety and~     feasibility of CAVU Medical, Inc.'s Attune Device.~   "
124737|NCT01422928|"~     Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without~     chemotherapy, affects the immune system, and to determine if acupuncture can modify these~     effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or~     genitourinary (GU) cancers.~      Clinical or Research Questions:~        1. Does RT reduce immune biomarkers in treated subjects?~        2. Which biomarkers are most affected by treatment?~        3. Is acupuncture a feasible option to help ameliorate any biomarker effects?~        4. Does RT affect subject symptoms?~        5. Is acupuncture a feasible option to help ameliorate any symptom effects?~   "
124738|NCT01422915|"~     The investigators demonstrated that cholestyramine is an effective binding agent in vitro~     for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous~     porphyria suggest that cholestyramine and colestipol effectively remove porphyrins.~     Hypothesis: orally administered colestipol will effectively lower erythrocyte porphyrin~     concentrations in subjects with erythropoietic protoporphyria (EPP).~   "
124739|NCT01422902|"~     This study is a multi-site, double-blind, randomized, controlled clinical trial to assess~     the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive~     remediation treatment versus a computer-based control.~      The investigators proposed that a computerized cognitive remediation program based upon the~     principles of brain plasticity may improve information processing and thus drive clinically~     significant improvements in cognitive and functional performance in individuals with~     schizophrenia.~   "
124740|NCT01422889|"~     The purpose of this study is to compile real-world clinical outcomes data for the ION™~     Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.~   "
124741|NCT01422876|"~     This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination~     (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to~     support approval by regulatory authorities.~   "
124742|NCT01422863|"~     The overall goal of this study is to determine the efficacy of a lifestyle intervention,~     consisting of a weight loss diet and exercise on sleep apnea in older adults. The~     investigators will conduct a 3-month intervention in men and women who are sedentary with~     suspected sleep apnea. The investigators hypothesize that the intervention will lead to~     marked improvements in sleep apnea severity and cardiovascular risk markers.~   "
124743|NCT01422850|"~     This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid~     Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single~     dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer~     patients will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from~     the patient's own immune system are isolated, activated and re-administered to the patient~     to boost a specific immune response against the cancer cells. The aim of the study is to~     show safety and tolerability for repeated dosing of this type of therapy. It is the~     hypothesis that the cells administered during the therapy will attack the tumor cells and in~     this way stop or slow down the progression of disease.~   "
124744|NCT01422837|"~     The objective of the VIVITROL Registry is to gather real world data on opioid dependence and~     to provide understanding of the health economics of opioid dependence.~   "
124745|NCT01422824|"~     This prospective observational study will evaluate the safety and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on~     haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving~     once monthly Mircera according to standard of care and local labelling during 12 months of~     treatment.~   "
124746|NCT01422811|"~     1. Background: In recent years an increasing trend in excessive lengths of stay has been~          recorded at the Parma University Hospital, compared with regional mean values.~          Excessive lengths of stay have been demonstrated to constitute not just an economic~          problem, but also a clinical and public health issue. Since the measures taken at our~          institution so far have not proven effective, the investigators carried out a~          literature review, which mostly detected observational studies, restricted to the~          assessment of the impact of a single intervention.~        2. Objectives: This project intends to evaluate the effectiveness of a multifaceted~          strategy aiming to empower clinicians on the issues associated with excessively long~          and avoidable hospital stays, and enable them to identify corrective measures~          (according to the principles of clinical governance).~        3. Study design: cluster-randomized, parallel group, open-label, community trial~        4. Methods: trained personnel will periodically record causes for excessive lengths of~          stay in all participating wards using an ad hoc data collection sheet. In the wards~          randomized to the experimental group, interventions aimed to clinician empowerment -~          provision of reminders and periodical audits - will be implemented.~        5. Expected results: A reduction in the experimental vs. the control arm unnecessary~          lengths of stay is expected, although the introduced measures will also presumably lead~          to improvement in the wards where they are not implemented.~   "
124747|NCT01422798|"~     The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high~     TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of~     the new WHO recommended TB drug dosages.~   "
124748|NCT01422785|"~     There are many different factors that cause acne. So combination treatment using different~     medications that can address these different factors is commonly used to treat acne.~     Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl~     peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of~     the medications when used together.~   "
124749|NCT01422772|"~     The purpose of this study is to evaluate the safety of VM202RY direct injection into the~     cardiac muscles of the coronary artery territory where complete revascularization could not~     be done even through Coronary Artery Bypass Graft.~   "
124750|NCT01422759|"~     Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal~     glands of girls with obesity and androgen excess~   "
124751|NCT01422746|"~     This study will test whether metformin administration can ameliorate androgen (male hormone)~     overproduction in overweight pubertal girls with androgen excess. The investigators~     hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration~     will improve androgen levels after adrenal stimulation testing with adrenocorticotropic~     hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin~     (rhCG).~   "
124752|NCT01422733|"~     This study will test whether longer-term suppression of adrenal function can ameliorate~     androgen (male hormone) overproduction in overweight early pubertal girls with androgen~     excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin~     hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will~     improve androgen levels in girls with adrenal androgen overproduction. Specifically, this~     intervention will improve androgen levels after adrenal stimulation testing with ACTH or~     ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).~   "
124753|NCT01422720|"~     This is an open Label study to investigate the safety and efficacy of eslicarbazepine~     acetate as adjunctive therapy for partial seizures in elderly patients.~   "
124754|NCT01422707|"~     Short term hydrocortisone to test whether improves excess androgen production from adrenal~     gland and ovaries~   "
124755|NCT01422694|"~     Background:~      - Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and~     joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the~     joints and spine. Some patients have SpA without ever developing these growths, while others~     develop them after only a few years. Researchers are interested in studying people with SpA~     and their relatives to determine which people are more likely to develop more severe~     conditions.~      Objectives:~      - To identify symptoms and medical tests that can help determine whether a person with SpA~     is at risk for developing more severe forms of the disease.~      Eligibility:~        -  Individuals of any age who have been diagnosed with SpA.~        -  Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA.~      Design:~        -  Participants will be screened with medical records and family medical histories, and~          will be invited to the clinical center for the study.~        -  Participants with SpA will have a physical exam and medical history, including a study~          of joint movement, blood and urine tests, and questionnaires about pain and quality of~          life.~        -  Participants with SpA will have imaging studies, including magnetic resonance imaging~          (MRI). Other samples such as skin tissue and bone marrow may also be collected for~          study.~        -  Healthy volunteers will provide a blood sample and cheek cell samples.~        -  No treatment will be provided, although treatment options will be discussed.~   "
124756|NCT01422681|"~     The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory~     load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to~     advance the respiratory care toward invasive mechanical ventilation in patients refractory~     to non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in~     patients already invasively ventilated, thereby accelerating the weaning process.~      The investigators intend to perform a multi-center experimental non randomized single arm~     prospective study to investigate the efficacy of the Decap Smart in reducing the intubation~     rate or the duration of invasive mechanical ventilation in patients with COPD treated either~     with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and~     hypercapnia. The results of the study will be compared to the data available in the~     literature.~   "
124757|NCT01422668|"~     The aim of this study was to evaluate the composition of Khalas, a very common type of dates~     used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI~     tests in both healthy and diabetic subjects.~   "
124771|NCT01422486|"~     Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat~     (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood~     cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic~     Syndrome (MDS).~   "
124758|NCT01422655|"~     Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in~     neonates, in relation to gestational age (GA), time (postnatal hour) and site (forehead,~     sternum, knee) of measurements.~      Hypothesis: Using (or combining) different sites for TcB determination might improve the~     accuracy of TcB in relation to the time of measurement and the GA of the neonate.~      Methods: The study will include neonates >32 weeks' gestation cared for in the well-baby~     nursery and NICU of the University Hospital of Patras, from September to December 2011. Data~     such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO~     group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight,~     postnatal medications and interventions, type and volume of feeding, and extension of~     jaundice, will be collected.~      TcB measurements will be performed using the BiliCheck bilirubinometer (according to the~     standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin~     (TSB) values will be obtained using the heel stick technique, and measurements will be~     performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew,~     NY). The accuracy of the device has been validated previously. TSB measurements will be~     performed within 5 minutes of the TcB measurements.~      At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement~     (postnatal hours), and the actual weight will be noted.~      Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman~     % method. The independent and joint effects of GA and time of measurement on bias will be~     evaluated by multivariate regression analysis.~   "
124759|NCT01422642|"~     The purpose of this study is to determine if there are any clinical or ROM differences in~     total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.~   "
124760|NCT01422629|"~     This study is a multicentre, open, uncontrolled trial for the observation of histological~     changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).~      This study will be conducted in France in 20 patients with breast fibroadenoma with~     indication for a surgical resection. The patient will receive an HIFU treatment and 6 months~     after treatment, the need of the surgery is evaluated.~   "
124761|NCT01422616|"~     ENCHANTED is an independent, investigator initiated, international collaborative,~     quasi-factorial randomised controlled trial involving a package of 2 linked comparative~     randomised treatment arms, which aims to address 4 key questions in patients eligible for~     thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg)~     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent~     benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP)~     lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline~     recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg)~     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of~     symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering~     to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?~      The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication~     of the results in May 2016. The BP intensity arm of the study is ongoing.~   "
124762|NCT01422603|"~     This study has been designed to investigate the safety and feasibility of using a~     chemotherapy drug, Clofarabine, to reduce the disease burden before a donor transplant, in~     patients with high risk Acute Myeloid Leukaemia or Myelodysplasia (MDS). In this study~     Clofarabine chemotherapy will be given a few days before a reduced or full intensity donor~     stem cell transplant and without waiting for normal blood counts to recover. It is hoped~     that this approach may improve the outcome for patients with high risk AML and MDS after~     their transplant.~   "
124763|NCT01422590|"~     1. Explore pharmacodynamics~             -  glucose~             -  insulin~             -  C-peptide~             -  glucagon~             -  intact GLP-1~             -  DPP-4 activity~             -  CGMS (continuous glucose monitoring system)~        2. Assess Safety~             -  adverse events~             -  clinical laboratory test~             -  physical examination~   "
124764|NCT01422577|"~     Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon~     cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve~     the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to~     compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis~     of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in~     the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology~     that enables endoscopists to obtain better images in suboptimal conditions. The study~     proposes to compare the performance of colonoscopy using either white light or bright NBI in~     subjects undergoing screening colonoscopy in search for colon adenomas.~      Purpose~      To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average~     risk subjects undergoing screening colonoscopy.~   "
124765|NCT01422564|"~     This trial will evaluate the 36mm or greater metal head on metal hip system and compare it~     to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a~     primary cementless total hip replacement.~   "
124766|NCT01422551|"~     The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress~     management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial~     adaptation and physiological adaptation in women being treated for stage I-III breast~     cancer.~   "
124767|NCT01422538|"~     This clinical trial will evaluate clinical outcomes associated with the non-invasive~     Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.~   "
124768|NCT01422525|"~     At present, trabeculectomy is the most common performed and effective surgical method of~     filtration surgery for patients with medically uncontrolled glaucoma.~      The aim of this prospective observational case study is to determine changes of the~     peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence~     tomography in patients with glaucoma after surgical reduction of intraocular pressure.~   "
124769|NCT01422512|"~     This study will evaluate safety and immunogenicity of surface, antigen, inactivated,~     influenza vaccine produced in mammalian cell culture when administered to adult and elderly~     subject.~   "
124770|NCT01422499|"~     The aim of this study is to define a dose recommendation of vorinostat in pediatric~     oncology, to determine pharmacokinetics of vorinostat in children, determine response rates,~     safety and feasibility.~   "
124772|NCT01422473|"~     The purpose of this study is to examine the advantages and disadvantages of using the EnSeal~     device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.~      It is hypothesized that the use of the Enseal device will demonstrate an improvement a~     patient's overall experience through less postoperative bleeding and pain, decreased time~     for wound healing, and a faster return to work.~   "
124773|NCT01422460|"~     The investigators will try to find any efficacy of platelet rich plasma injection for the~     treatment of osteoarthritis (OA) in the subtalar joint. Autologous platelet-secreted growth~     factors (GFs) may have therapeutic effects in OA capsular joints via multiple mechanisms.~     The investigators aim is to examine the effect of a platelet-derived preparation rich in~     growth factors(PRGFs) in OA of the subtalar joint, using parameters of pain, function,~     quality of life and safety.~   "
124774|NCT01422447|"~     The purpose of this research is to establish a suitable community-based model for Chinese~     culture,to improve the community recognition of common mental disorders,as well as its~     treatment and control.~   "
124775|NCT01422434|"~     The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once~     daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once~     daily in Japanese subjects with psoriasis vulgaris.~   "
124776|NCT01422421|"~     The purpose of this study is to determine whether intensive blood pressure and low density~     lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in~     Japanese diabetic patients with coronary artery disease and history of acute coronary~     syndrome.~   "
124777|NCT01422408|"~     This phase II trial studies how well giving fluocinonide cream works in treating symptoms of~     vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing~     hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual~     intercourse in patients undergoing hormone therapy.~   "
124778|NCT01422395|"~     Indications for oocyte (egg) vitrification (fast freezing) include the preservation of~     reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or~     surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows~     patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical~     dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation~     could allow women to delay childbearing if they want or need to. Until recently,~     conventional cryopreservation protocols have remained too inefficient for practical~     application in an infertility center. Very little is known about the effects of~     vitrification on oocytes and subsequent embryo development, especially using the sibling~     model (group of oocytes from the same cohort of ovarian follicles within patient). The~     purpose of this study is to examine the effect of oocyte vitrification on fertilization~     rates, embryo quality and development.~   "
124779|NCT01422382|"~     This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug~     interaction study.~   "
124780|NCT01422369|"~     This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug~     interaction study.~   "
124781|NCT01422356|"~     Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital~     Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions~     including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of~     cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by~     programs. This study will explore the prevalence of HPV infection and sexual behaviours~     associated with varying prevalence of HPV infection.~      The investigators will survey 200 MSM aged 16-20 years who just started their sexual life.~     The investigators will use a questionnaire to collect information of socio-demographic~     characteristics, lifetime sexual experience, recent sexual experience, the most recent~     sexual contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV~     knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also~     collect oral, penile and anal samples as well as blood samples to test for HPV DNA and~     antibody.~      The study will include four visits in the 12-month period. In each visit, participants will~     be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood~     samples.~   "
124782|NCT01422343|"~     Although microparticles have been well-documented as mediators of inflammation and~     coagulation in various cardio-vascular disease events, it is currently not known how~     Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences~     microparticle numbers, phenotype and distribution pre- and post interventionally and how~     they are related to or affect the incidence of early re-stenosis - or if indeed they may be~     used to predict patients at risk of early re-stenosis.~   "
124783|NCT01422330|"~     The purpose of this study is to learn more about the safety and tolerability of etravirine.~     Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has~     shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains~     resistant to other non-nucleotide agents.~   "
124784|NCT01422317|"~     The object of this study was to evaluate the effect of a high-dose ethylester concentrate of~     of n-3 fatty acids administered early after an acute myocardial infarction on subsequent~     cardiac events and serum lipids.The second purpose of this study was to assess the impact of~     high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial~     dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged~     wash-out-period.~   "
124785|NCT01422304|"~     This study will assess the effect of reversal of neuromuscular blockade with sugammadex~     compared with reversal according to usual care (neostigmine or spontaneous reversal) on the~     incidence of post-surgical bleeding events and on coagulation parameters in participants~     undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular~     blockage induced by rocuronium or vecuronium.~   "
124786|NCT01422291|"~     This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous~     single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.~   "
124829|NCT01421732|"~     A study of dengue in children presenting to outpatient departments of 5 large hospitals in~     Ho Chi Minh City and Tien Giang province, Viet Nam.~      Different blood tests are compared at the early stages of dengue fever onset in their~     ability to accurately and specifically detect children whose dengue will progress to severe~     disease.~   "
124787|NCT01422278|"~     Evaluating the effects in functional status after three weeks of cognitive - and behavioural~     rehabilitation on patients with gait disorder. The patients are followed up as after 1 and~     12 months to study if any improvement is still present. The patients are being recruited~     from neurological units. The intervention is explanation of symptoms, positive reinforcement~     of normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the~     study aims at describing typical gait patterns at patients with gait disorder by using~     biomechanical measurements (EKG).~   "
124788|NCT01422265|"~     This multicenter, observational, prospective study will include approximately 20 US-based~     centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary~     peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months~     after first-line platinum-based chemotherapy (first recurrence). Patients who have completed~     second-line chemotherapy and are currently in observation or undergoing bevacizumab~     maintenance treatment will be eligible to participate in the study.~   "
124789|NCT01422252|"~     The objective of this study is to evaluate the evolution 6 months after a fall occurring at~     home in people over 75 equipped or non-equipped with a precocious detection device. The~     possibility to establish a relation between the alert emitted by the device, the time~     separating the fall from the arrival at hospital and the potential consequences for the~     persons will be analyzed with the greatest accuracy. Besides, the sequences of intervention~     of the different operators will be described with precision. 200 persons living at home in~     the ESSONNE(France)and having fallen at least one time during the previous 3 months will be~     included in the study and two groups of 100 will be constituted randomly after having signed~     a written consent. Of the 2 groups, one will be constituted with persons equipped with a~     precocious fall detection device named Vigi'Fall® , the second being non-equipped. After a~     first visit checking that the inclusion criteria are abide by and the installation of the~     device in the persons designated randomly for being equipped, a second visit will be carried~     out after 10 months in order to know the evolution, i.e. if the persons are still alive,~     living at home or having left for admission in an institution (hospital, nursing home,~     retirement home...). By a detailed comparison between the 2 groups, it will be possible to~     evaluate the potential interest of having been equipped or non-equipped with a precocious~     fall detection device. Hence, a change in practices may lead to a prevision of elderly~     persons likely to benefit of a precocious detection device and to the development of~     prevention in hospital geriatric departments, geriatric care networks, emergency departments~     and local services for the elderly and disabled. Another possible gain of the study is to~     sensitize the medical, paramedical and social teams to the usefulness of precocious~     detection devices in elderly subjects at risk for falls.~   "
124790|NCT01422239|"~     The purpose of this study is to develop and pilot test a smoking cessation counseling that~     focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and~     negative affect, loss of enjoyment).~      Aim 1: To develop the risk-based smoking cessation intervention.~      Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks~     of quitting is feasible to administer and acceptable to adult women who want to quit~     smoking.~      Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment~     in comparison to standard smoking counseling. It is expected that women who receive~     risk-based counseling will show better quit rates and a longer time to relapse than women~     who receive standard treatment.~   "
124791|NCT01422226|"~     Over the last several years, more and more women are choosing intrauterine contraception~     (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal~     sterilization, with an overall unintended pregnancy rate of less than 1% in the first year,~     and lower failure rates in subsequent years. Intrauterine contraception has many attributes~     besides its effectiveness; it is easily reversible, has a low side-effect profile, and~     provides a long-term solution for contraception (10 years for the copper T380 and 5 years~     for the levonorgestrel IUD). In addition, using an IUD for birth control requires little~     on-going effort by the woman to be effective and offers immediate return to fertility with~     its removal.~      The biggest increase in users is among nulliparous women (women who have not had children),~     due to increased awareness of the safety of modern IUDs in this population, and the many~     benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in~     nulliparous women, and the American College of Obstetricians and Gynecologists supports the~     use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous~     woman has a smaller diameter which can lead to more difficult and uncomfortable IUD~     insertions. Many providers avoid offering IUDs to nulliparas because of fears that the~     procedure will be more difficult, and may require cervical dilation, placement of a~     paracervical nerve block, or placement under ultrasound guidance, none of which are standard~     for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of~     misoprostol's known ability to cause cervical dilation, some family planning providers give~     their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is~     commonly used to dilate the cervix for similar procedures as in first trimester abortions,~     hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is~     unknown, and some concern exists that uterine contractions caused by the drug may lead to~     device expulsion or displacement.~      In this study, the investigators propose to ask nulliparous women who have undergone~     contraceptive counseling and decided to use an IUD for birth control to be randomized to the~     use of misoprostol or placebo prior to their scheduled IUD placement.~   "
124792|NCT01422213|"~     Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD~     primarily involves mood disturbances, patients also usually present alterations in cognitive~     function (attention, memory, executive functioning and psychomotor speed). Even though~     antidepressants are suggested in the literature to potentially improve cognitive dysfunction~     in patients with MDD to some degree, there is a lack of adequate and well-controlled studies~     to investigate this effect. This study will evaluate the efficacy, safety and tolerability~     of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult~     patients with MDD.~   "
124793|NCT01422200|"~     The purpose of the study is to compare the immune response of two different injection~     methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine~     among patients with neuromuscular conditions who have significant muscle degeneration. This~     research study hypothesizes that the subcutaneous route of vaccine administration, as~     compared to the intramuscular route, may confer at least comparable, or possibly better,~     immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive~     Care Center will be recruited to participate in this study lasting approximately one to two~     months with two clinic visits and one follow-up telephone call. Immunogenicity will be~     assessed by comparing hemagglutination inhibition (HAI) antibody titers obtained pre- and~     post-vaccination.~   "
124794|NCT01422187|"~     This is a multi-center trial to further extend the assessment of the safety and efficacy of~     taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled~     in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of~     taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months~     or until taliglucerase alfa is commercially available to the subject at the discretion of~     the Sponsor.~   "
124866|NCT01421251|"~     Many people worldwide received the monovalent adjuvanted H1N1 vaccine. However, very little~     is known about the safety of the vaccine, particularly beyond the first few weeks after~     vaccination. This study will combine data from a well-established immunization registry in~     Manitoba with data from hospitalization and physician records, to examine the safety of the~     vaccine in the six month period post-vaccination. Studies on vaccine safety are important as~     the public's perception of the safety of a vaccine has a major role in its uptake.~   "
124795|NCT01422174|"~     INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at~     industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as~     extended as expected, with respect to indications for primary prevention defibrillator~     implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.~      OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading~     primary prevention by the means of clinical evidence on real risk of death in this group of~     patients.~      REGISTRY DESIGN:~        -  retrospective (at stage 1); prospective (at stage 2)~        -  multi-center (minimum 25-30 centres)~        -  international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)~        -  non randomized.~        -  Sample size: at screening about 12.500 patients and 962 patients at treatment stage~      REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT~     (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).~   "
124796|NCT01422161|"~     The purpose of this study is to determine whether injections of botulinum toxin (commonly~     known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles~     controlling the hand, will lead to improved use of the hand when compared to injections of~     placebo (a substance that looks similar to the study drug but contains no active study~     medication).~   "
124797|NCT01422148|"~     Postoperative atrial fibrillation (POAF) is a common complication after heart surgery.~      Amiodarone is the drug of choice to treat POAF. Inflammation is considered one of underlying~     factor for POAF. Minocycline is an antibiotic with anti-inflammatory properties.~   "
124798|NCT01422135|"~     This is a pharmacokinetics and safety study over 3 weekly applications.~   "
124799|NCT01422122|"~     There is a gap in knowledge regarding the effects of Vitamin D supplementation on~     periodontal status in pregnant wome. The investigators aim to evaluate the potential~     benefit, if any of vitamin D supplementation during pregnancy on periodontal disease and~     relevant outcomes including burden of infections and prematurity rates.~      the investigators hypothesize that~        1. Vitamin D supplementation during pregnancy improves the periodontal health.~        2. There is an association between inflammatory biomarkers and periodontal health of~          pregnant females.~        3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates~          and birth weight~   "
124800|NCT01422109|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by~     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in~     healthy male volunteers.~   "
124801|NCT01422096|"~     This study will test whether short-term suppression of ovarian function can ameliorate~     androgen (male hormone) overproduction in overweight girls with androgen excess. The~     investigators hypothesize that one dose of depot leuprolide agonist administration will~     improve androgen levels in girls with ovarian androgen overproduction. Specifically, this~     intervention will improve androgen levels after ovarian stimulation testing with recombinant~     human chorionic gonadotropin (rhCG).~   "
124802|NCT01422083|"~     A loss of mobility in the shoulder in direction of internal rotation is associated with~     shoulder tendon pathology. Cause-effect relationship between these two is still not clear.~     It is suspected that this loss of mobility reduces the size of the tunnel in which this~     shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show~     glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain.~     This makes this population interesting to investigate. This study wants to look at shoulders~     of overhead athletes with GIRD and measure the size of the subacromial space. After this,~     the athletes will be instructed to perform a home stretching program and at the end the~     effect of this on mobility and the size of the subacromial space will be measured.60~     athletes will be recruited and randomly allocated to the control group and the stretching~     group. Before they start stretching, subacromial space size will be measured by use of~     ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use~     of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a~     stretching exercise, which they will be performing at home once a day during 6 weeks. At the~     end all outcome measures will be reassessed.~   "
124803|NCT01422070|"~     The starting point of ELOISE is the significant number of Intensive Care Unit (ICU)~     survivors who die after the transfer to ward. This mortality rate nullifies the~     sophisticated diagnostics and the life-support therapies adopted in the ICU.~      The inadequate care available at the destination ward has been suggested as one of the~     reasons to explain the bad outcome of some ICU survivors, but most hospitals do not have~     enough ICU beds to prolong the ICU stay until the patient has fully recovered. Therefore,~     Inter Mediate Care Units (IMCU) with levels of nursing staff and costs lower than ICU but~     higher than wards have been proposed to facilitate discharges of ICU patients. Unfortunately~     the literature does provide evidence of efficacy of IMCU.~      The primary aim of the study is to assess whether the patients admitted to ICUs with~     availability of IMCU have lower hospital mortality than those admitted to the ICU without~     availability of IMCU.~      Secondary aims are as follows:~        1. To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients~          admitted to ICUs with or without availability of IMCU.~        2. To assess the influence of IMCU on the rate of ICU readmissions.~        3. To compare the hospital survival of patients discharged to IMCU and general ward (in~          hospital with or without availability of IMCU) adjusted for severity of illness and~          nursing workload at ICU discharge. This last aim will require a larger sample size~          (more than 10,000), but we hope to collect such a sample.~   "
124804|NCT01422057|"~     The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a~     prognostic marker in type-2 diabetics with ischemic heart disease~   "
124805|NCT01422044|"~     The purpose of this study is to test the prognostic value of autonomic markers in patients~     with aortic stenosis.~   "
124900|NCT01420809|"~     This post-marketing surveillance study was designed to collect and assess the information on~     proper use of fondaparinux injection, such as the safety and efficacy under actual use~     conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of~     developing venous thromboembolism.~      (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)~   "
125110|NCT01418053|"~     The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with~     caraway oil is effective in the treatment of abdominal pain and complaints caused by~     Irritable bowel syndrome.~   "
124806|NCT01422031|"~     The aim of this study was to find out the utilization rate and pattern of primary health~     care services, and the process and outcomes of primary care consultations of the general~     population in Hong Kong, and whether having a family doctor would make any difference.~      The study objectives were to determine~        1. the rates and pattern of utilization of different primary health care services and~          self-care~        2. Patient self-reported outcomes (global rating on change in health, satisfaction and~          patient enablement) of primary care consultations;~        3. the process of care in consultations including drug and non-drug managements,~          investigations, preventive care and referrals;~        4. the effect of having a regular family doctor on service utilization rate and pattern,~          health promotion practice, and process and outcomes of primary care consultations.~   "
124807|NCT01422018|"~     Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard~     exudates secondary to diabetic retinopathy.~      Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive~     patients showing focal edema with hard exudates secondary to diabetic retinopathy which are~     not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).~   "
124808|NCT01422005|"~     The purpose of this study is to examine if practicing joint movements using specially~     designed devices can help in the recovery of muscle function in the arm/hand after a stroke.~     Subjects may qualify for participation in this study because they had a stroke and have had~     difficulty using their affected arm/hand ever since.~   "
124809|NCT01421992|"~     The purpose of this study is to determine whether methylphenidate is effective in the~     treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).~   "
124810|NCT01421979|"~     The aim of this study is to examine the safety and the effects of EDs at high doses, either~     alone or in combination with other risk factors such as alcohol intake, physical exercise~     and sleep deprivation, on cardiovascular markers and subjective health.~   "
124811|NCT01421966|"~     Chronic foot ulcers are particularly prevalent in patients with underlying diabetes~     mellitus. These ulcers are reported to be the leading cause of hospitalization among people~     with diabetes.~      The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity~     ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing~     activated homologous white blood cells prepared from donated healthy whole blood. A total of~     280 patients will be randomized to receive either CureXcell® or sham.~   "
124812|NCT01421953|"~     Computed tomography (CT) images, used for radiotherapy planning, are often caught out in~     lung target volumes delineation because of their inability to differentiate between~     neoplasia, inflammation and atelectasia. Positron Emission Tomography (PET) is a new~     functional imaging modality and is currently used in the diagnosis and the staging of lung~     cancers. The aim of this study is to evaluate the impact of 4D 18F-FDG-PET-CT on~     radiotherapy planning for lung cancers.~   "
124813|NCT01421940|"~     Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to~     the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The~     purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical~     co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal~     excision.~   "
124814|NCT01421927|"~     Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a~     controversial topic because of a high risk of relapse and a significant transplant-related~     mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now~     performed after reduced-intensity conditioning regimens. In these conditions, TRM usually~     range from 10 to 20%. However, reducing the intensity of the conditioning invariably~     increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant~     strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be~     considered and evaluated.~   "
124815|NCT01421914|"~     This is a study to calculate the minimum effective volume of bupivacaine 0,5% with~     epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the~     patients (MEV50).~   "
124816|NCT01421901|"~     The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the~     highest incidence in the second decades . The aetiology of AA is still poor understood: the~     commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix~     barrier and thus wall perforation and/or abscess formation1. However some studies suggest~     that no-complicate and complicate appendicitis are different entities allowing a different~     treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic~     treatment compared to surgery in a population with high probability to suffer of 1st episode~     of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment~     compared to surgery in a population with high probability to suffer of 1st episode of AA.~   "
124817|NCT01421888|"~     Objectives:~        -  To study nutrition and immune system problems in people with urea cycle disorders.~        -  To study how people with urea cycle disorders and healthy volunteers respond to~          standard flu and/or hepatitis A vaccines.~        -  To compare differences in nutrition and immune systems of people with urea cycle~          disorders with that of healthy volunteers.~      Eligibility:~        -  Healthy males and females at least 2 years of age who are able to travel to the~          National Institutes of Health hospital in Bethesda, MD~        -  Males and females at least 2 years of age who have a urea cycle disorder and are able~          to travel to the National Institutes of Health hospital in Bethesda, MD.~      Design:~      For Patients with urea cycle disorder:~        -  Participants will spend 2 to 3 days in the National Institutes of Health hospital for~          the following tests:~        -  A physical exam and review of medical history~        -  Food log for 3 days before the start of the study~        -  Blood tests~        -  24-hour urine collection~        -  Resting metabolism test~        -  DEXA scan imaging study of bones and body fat~        -  Participants who are old enough to do certain tasks by themselves (like dressing and~          eating) can choose to have the following extra tests:~        -  24-hour metabolic room measurements~        -  BodPod(Registered Trademark) study to measure bones and body fat~        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the~          study and will be monitored to check for possible side effects.~        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.~      For Healthy Volunteers:~        -  Participants will be seen at the outpatient clinics at the National Institutes of~          Health hospital for up to 2 visits for the following:~        -  Review food log completed 3 days before the start of the study~        -  Blood tests~        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the~          study and will be monitored to check for possible side effects.~        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.~        -  Review of second food log completed 3 days before second outpatient visit~   "
124818|NCT01421875|"~     RATIONALE: Studying blood samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and~     outcomes in samples from older patients with acute myeloid leukemia.~   "
124819|NCT01421862|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer who failed~     treatment may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer resistance. It may also help doctors find better ways to treat~     cancer.~      PURPOSE: This research trial studies biomarkers in samples from adult patients with acute~     myeloid leukemia who failed standard-of-care treatment.~   "
124820|NCT01421849|"~     Study hypothesis: that there would be no difference in patient satisfaction among~     institutionalised older people before and after treatment with a mandibular single~     implant-retained overdenture.~      In a preliminary phase, a new denture is made or the old denture is adapted to provide a~     well-fitting denture.~      Eight weeks after insertion of the new denture a single implant is placed in the centre of~     the mandibula. If the level of primary stability is sufficient to enable the implant to~     resist micromovement, the implant is immediately loaded . If not, the implant is loaded~     after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the~     clinician's interpretation and tactile sense of primary stability. Before, during and after~     the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item~     questionnaire and a clinical examination.~   "
124821|NCT01421836|"~     1. Purpose of the study~           -To compare stent patency and complication rate between endoscopic ultrasound (EUS)~          guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided~          stent insertion for malignant biliary obstruction~        2. Subjects of the study~           -Patients who have biliary obstruction owing to malignant tumors~        3. Methods of the study~             -  Prospective randomized controlled study~             -  Patients were enrolled randomly in two groups, EUS guided stent insertion group or~               ERCP guided stent insertion group~             -  Patients will get assigned procedure (EUS guided stent insertion or ERCP guided~               stent insertion)for decompression of malignant biliary obstruction~             -  After the procedure, regular follow up, blood test,and imaging test will be done~               to check sufficient biliary decompression,stent patency and complications.~   "
124822|NCT01421823|"~     The purpose of this study is to assess the effect and safety of alpha agonist ointment on~     fecal incontinence severity in patients with idiopathic fecal incontinence.~   "
124823|NCT01421810|"~     Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body~     hair, irregular menstrual periods, or no menstrual periods excess body weight, and~     infertility. It also results in elevated androgen levels such as testosterone. In women with~     PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown~     whether the ovaries are fully active during early puberty. The purpose of this study is to~     determine how the ovaries contribute to the production of male hormones in the body during~     different stages of puberty, so that it can be better understood why some females have~     excess androgens.~   "
124824|NCT01421797|"~     Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much~     facial and body hair, and weight gain. Women with PCOS also have a hard time becoming~     pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as~     adults. Some girls with high levels of male hormone will develop normal hormone levels as~     they grow up, but most girls continue to have high levels of male hormone as adults. The~     purpose of this study is to understand where the male and female hormones come from in girls~     as they get older. The investigators think the adrenal gland, makes most of the hormones in~     young girls and that the ovary and the adrenal gland make these hormones in older girls. The~     investigators would like to find out whether an overactive adrenal gland makes these~     hormones higher in girls who are overweight, compared to those who are not overweight.~   "
124825|NCT01421784|"~     In this study, the researchers investigate the feasibility of using rapid cine MR imaging to~     provide both offline and online soft-tissue-based image guidance. Such images will provide a~     significantly more complete picture of the spatial and temporal changes in thoracic anatomy.~     This more complete information will lay the groundwork for better radiotherapy planning and~     dose delivery in the presence of respiratory motion.~   "
124826|NCT01421771|"~     Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although~     studies in the general population have demonstrated a continuous reduction in CV risk with~     each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in~     hemodialysis (HD) patients have demonstrated that patients with mild to moderate~     hypertension may have decreased mortality compared to those with normal blood pressure (BP).~     The investigators recently reported that among HD patients, those with routine pre-dialysis~     BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines~     (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate~     hypertension. However, these observational studies included untreated patients in whom low~     or normal BP may reflect significant cardiac disease or other comorbid conditions. In the~     setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering~     may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering~     will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to~     answer this important question. Prior to conducting a full-scale RCT it is prudent to~     conduct a pilot study to assess feasibility and inform the design of the former. The~     investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess~     the safety and feasibility of treating patients to a low (110-140 mmHg)and standard~     (155-165) mm Hg pre-dialysis BP target.~   "
124827|NCT01421758|"~     This study was designed to determine whether participation in an online social network~     intervention increases perceived social support for physical activity versus a minimal~     education control group by conducting a randomized controlled trial with 140 female~     undergraduate students. The investigators hypothesize that participants in the physical~     activity centered online social network intervention group will have greater increases in~     perceived social support for physical activity compared to minimal web based physical~     activity education controls.~   "
124828|NCT01421745|"~     There are three purposes for this study:~      I. to establish the construct validity (via factor analysis) of the Inventory for Assessing~     the Process of Cultural Competence Among Healthcare Professionals - Student Version~     (IAPCC-SV) II. to determine the responsiveness of the IAPCC-SV III. to investigate~     demographic predictor variables of the IAPCC-SV~      It is hypothesized that:~      I. the variables will load on only one component, with each component being represented by a~     number of strongly loaded variables II. the IAPCC-SV will demonstrate responsiveness,~     evidenced by significantly higher post-module IAPCC-SV scores of the experimental group when~     compared to the control group III. the cultural composite score and race will be significant~     predictors of IAPCC-SV score~   "
125111|NCT01418040|"~     This is a single centre prospective observational noninterventional study of men with~     histological confirmed prostate cancer, high risk disease and not positive for metastatic~     disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT).~     Although ADT improves the chance of cure, it can also have many side effects. One of these~     is bone mineral density loss. When this is advanced, it is called osteoporosis. Men with~     osteoporosis have a higher chance of getting fractures of bones such as the hip and spine.~     Currently, the best way to measure for osteoporosis is to do a bone mineral density scan~     using a DEXA scanner.~      The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI)~     and a Computer Tomogram (CT) combined with clinical factors predicts which men are at~     greater risk of accelerated ADT induced bone mineral density loss than baseline DEXA~     scanning alone. The data from the patients will be used to construct a model predicting~     annual rate of bone loss based on baseline imaging, clinical and biochemical~     characteristics.~      Secondary aims for this study are as follows:~        -  Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical~          control by the Phoenix definition)of multimodality therapy with hypofractionated~          radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks~          compared with a standard 8 week approach). Although used overseas, this 5½ week regimen~          has not been used widely in Australia, and we would like to see if we gain similar~          results here as have been reported from the US.~        -  Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy.~          Usually, ADT is given for between 19 months before radiotherapy is started but there is~          no agreement as to which duration is best. This trial aims to tailor the duration of~          ADT prior to radiotherapy based on blood PSA test results.~        -  Prognostic value of circulating tumour cells (CTCs). This is a blood test which can~          detect cancer cells in the blood which has been used for patients with metastatic~          cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall~          survival. Potentially, high risk prostate cancer patients with CTCs detected may~          represent a very high risk group and could therefore warrant treatment intensification.~        -  To correlate bone marrow changes on MRI with changes in blood counts and patient~          reported fatigue. Measuring bone marrow may help in predicting not just which patients~          are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue.~          A correlation may better explain some of the toxicities associated with ADT.~        -  Implementation of a nomogram based radiotherapy target delineation algorithm. This~          trial aims to use a decision making tool called a nomogram to help tailor the area to~          treat in a more standard way.~   "
124830|NCT01421719|"~     The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of~     frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur~     at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer~     from this disease, they are also prone to development of benign prostatic hyperplasia (BPH)~     and consequent associated lower urinary tract dysfunction. Similarly the over 65-year age~     group develop spontaneous overactive bladder up to a prevalence of 30% of both men and~     women. The urologic disorder is exceedingly devastating in reducing the quality of life in~     these individuals due to the lower urinary tract symptoms and ultimate urinary incontinence~     in a high proportion of patients.~      While attempts at pharmacologic treatment are partially satisfactory many patients are~     intolerant of oral drugs.~      Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in~     reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of~     neurogenic bladder causes of over activity . The treatment procedure of injecting the~     detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks~     to the patient, and can be performed as an office urologic procedure.~      This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A~     injections into the bladder to improve urinary symptoms in 20 patients.~   "
124831|NCT01421706|"~     Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy~     subjects~   "
124832|NCT01421693|"~     The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever.~     Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be~     assigned to one of the two treatments by chance and followed for 6 months. The two treatment~     groups will be compared to see which treatment is more likely to make the patient better.~   "
124833|NCT01421680|"~     The objective of this study is to evaluate the effect of a perioperative nutrition strategy~     using oral nutritional supplements (ONS) on postoperative complications and improvement in~     body weight in malnourished patients who underwent gastrectomy.~   "
124834|NCT01421667|"~     This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and~     safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin~     lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab~     vedotin in combination with rituximab in patients with relapsed or refractory diffuse large~     B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression~     and response in DLBCL (Part C).~   "
124835|NCT01421654|"~     The purpose of the study is to evaluate if using the Acclimate feature at the beginning of~     Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least~     as long as they would standard therapy. Additionally, the Acclimate feature will be~     evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events,~     and respiratory events.~   "
124836|NCT01421641|"~     The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine~     injection versus topical lidocaine gel on the pain experienced by patients undergoing~     tenaculum application to the cervix during office gynecologic procedures. This study will~     also evaluate how satisfied women are with the method of pain control used.~      The researchers hypothesize that:~        1. There is less pain perceived by patients undergoing placement of a tenaculum on the~          cervix when a lidocaine injection is used compared to a topical lidocaine gel.~        2. Patients are more satisfied with pain control during the overall experience of~          undergoing tenaculum placement on the cervix when a lidocaine injection is used~          compared to a topical lidocaine gel.~   "
124837|NCT01421628|"~     Ageing is related to a decrease in physical fitness, disability and age related symptoms~     like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical~     activity and mobility to increase physical fitness and decrease disability and nocturnal~     cramp in older adults.~   "
124838|NCT01421615|"~     The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial~     vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for~     the patients with durative positive result. It is assumed that the living preparation of~     lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment~     can increase the response rate and improve pregnancy outcomes in the durative BV positive~     patients comparing with one-course one.~   "
124839|NCT01421602|"~     This study will hypothesize that the use of a self fixating lightweight mesh in open~     inguinal repair is feasible in the Philippine setting. It will result in a comparable~     recurrence rate as published for the traditional Lichtenstein approach.~   "
124840|NCT01421589|"~     Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in~     obesity is associated with increased cardiovascular disease risk. However, it is not yet~     known how reduced GH increases cardiovascular disease risk in obesity. The investigators~     hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the~     investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH~     will improve mitochondrial function and that this improvement in mitochondrial function will~     contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The~     investigators propose to study skeletal muscle mitochondria in obese subjects with reduced~     GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after~     treatment with GH.~   "
124841|NCT01421576|"~     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect~     on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male~     volunteers.~   "
124842|NCT01421563|"~     The purpose of this study is compare the safety and pharmacokinetic characteristics of~     DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid)~     after oral administration in healthy male volunteers.~   "
124910|NCT01420679|"~     The purpose of this study is to see if pralatrexate extends response and survival following~     CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone)~     and if pralatrexate improves response in patients with partial response following CHOP-based~     chemotherapy. Patients will either receive pralatrexate or be under observation. All~     patients will receive vitamins B12 and folic acid and attend regular clinic visits to~     evaluate their disease and health.~   "
124911|NCT01420666|"~     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are~     greater than acetaminophen, ibuprofen or placebo in patients who have painful osteoarthritis~     of the hip or knee.~   "
124843|NCT01421550|"~     The purpose of the present study is to investigate whether or not to perform elective~     surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are~     no other randomized controlled trials in this area. The optimal management in patients with~     umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical~     opinion is that umbilical hernias in patients with ascites should not be corrected because~     of the supposedly high operative risks and high recurrence rates. Conservative treatment,~     however, can have severe complications resulting in emergency repair. Such operations carry~     a higher risk of complications than elective operations, particularly in this group of~     patients. Prospective and retrospective series showed us that elective hernia repair in this~     specific patient group is safe without major complications or high recurrence rates.~      The aim of this study is to asses the optimal timing of correction of umbilical hernia in~     patients with liver cirrhosis and ascites.~   "
124844|NCT01421537|"~     OVERVIEW:~        -  Thromboembolisms represent a serious and feared complication in hospitalized patients.~        -  Several factors make the ICU patient population at increased risk of venous~          thromboembolism.~        -  A high incidence of thromboembolic events is starting to emerge from recent medical~          literature in the burn patient.~        -  Actual guidelines for thromboprophylaxis in burn care patients are based on multiple~          non-burn patient trials.~        -  Burn patient physiology is radically different than that of general ward hospitalized~          patients~        -  Since the actual chemical thromboprophylaxis have not been evaluated in the burn~          patient, it is of interest to assess their efficacy in patients with severe burns.~        -  Hence, the pharmacokinetic characterization of heparins (a well accepted mode of~          thromboprophylaxis) in burn patients could guide future quality of care for this~          subclass of patients.~      Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight~     heparins in the burn patients do not correlate with levels described to prevent~     thromboembolic events in the general hospitalized population.~      The investigators aim to:~        1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins~          (enoxaparin), with anti-Xa levels in severely burned patients receiving~          thromboprophylaxis.~        2. To determine the correlation between antithrombotic activity of heparins and the~          different metabolic phases of the thermally injured patient.~   "
124845|NCT01421524|"~     The main purpose of this first in human study with CC-122 is to assess the safety and action~     of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with~     advanced tumors unresponsive to standard therapies and to determine the appropriate dosing~     level and regimen for later-stage clinical trials.~   "
124846|NCT01421511|"~     This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to~     oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg~     every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start~     treatment with at least 2 IV doses and may receive IV therapy for the entire treatment~     duration.~      Approximately 100 to 140 sites globally will participate in this study. Patients with an~     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be~     randomized 1:1 to study treatment.~   "
124847|NCT01421498|"~     The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%)~     compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118~     Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered~     BID for 12 weeks will also be evaluated.~   "
124848|NCT01421485|"~     Youth and young adults in the juvenile justice system have a high prevalence of concurrent~     psychiatric and substance use disorders and are also at high risk for HIV. However, even~     when the disorders and risks are recognized, most programs do not address all of these~     important problems and long-term efficacy for all outcomes simultaneously has yet to be~     demonstrated for these multi-problem youth. Adverse outcomes for youth include partially~     treated or relapsing psychiatric disorders, continued substance abuse, unchanged HIV risk,~     and further legal problems. This project, in collaboration with the Rhode Island Family~     Court, with whom we have existing collaborations, will address these issues by implementing~     an Integrated Treatment Program (ITP) that targets mental health/substance abuse disorders~     and HIV risk. ITP is novel by targeting multiple adolescent problems simultaneously,~     involving parents to augment change, and its delivery within the Family Court. This study~     will extend our previous efficacious interventions among youth with psychiatric disorders to~     court-involved youth. Adolescents and their parents will be enrolled from the Rhode Island~     Family Court Mental Health Clinic where youth aged 13-17 are referred by judges for~     comprehensive assessment and referral for treatment. This randomized controlled trial will~     test the efficacy, among 200 sexually active court-involved youth who need outpatient~     treatment, of the novel, integrated treatment (ITP, n=100) as compared to enhanced standard~     care in community outpatient services (ESC, n=100) over an 18-month period (6 months of ITP~     or ESC and 12 months of follow-up). ITP consists of three components: 1) individual~     cognitive behavioral therapy which includes a motivational interviewing component and is~     modular-based to address concurrent mental health and substance abuse issues; 2) family and~     parent training sessions to address parental communication and monitoring to support risk~     reduction among youth; 3) multifamily group workshops to address HIV risk, family~     communication and peer resistance skills. Youth in both conditions (ITP and ESC) will~     receive similar case management services from the court and psychiatric medication~     management (if needed) from a study psychiatrist. ITP will be compared to ESC on reductions~     in sexual risk behavior, substance use, symptoms of psychiatric disorders, and legal~     offenses.~   "
124849|NCT01421472|"~     To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment~     with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2~     negative locally advanced operable breast cancer patients.~   "
124850|NCT01421459|"~     The main purpose of this study is to compare the effectiveness and safety of LY2963016~     versus Lantus in controlling blood sugar levels in combination with two or more oral~     diabetes medications.~   "
124851|NCT01421446|"~     This study is comparing a new computer-based method of administering neuropsychological~     tests to the standard method of verbal and paper/pencil tests administered in person by an~     examiner. The purpose of the research is to determine if the computerized and standard~     testing methods are equivalent.~   "
124852|NCT01421433|"~     Non inferiority, multicentric, double blind study whose the primary objective is to compare~     the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain~     average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain~     evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal~     system.~   "
124853|NCT01421420|"~     The main objective of this research project is to provide a comprehensive clinical database~     of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild~     cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to~     identify cognitively normal individuals at genetically defined risk for Alzheimer's disease~     through genetic screening.~      All participants are seen annually. Autopsies to establish diagnoses in patients with~     dementia, patients with mild MCI, and cognitively normal elderly control subjects will also~     be conducted.~   "
124854|NCT01421407|"~     Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease~     (CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is~     characterized by persistently elevated levels of parathyroid hormone (PTH) and major~     disturbances in phosphorus and calcium metabolism. When glomerular filtration rate (GFR)~     falls, the phosphorus clearance decreases significantly, leading to phosphorus retention.~     The resulting hyperphosphatemia is thought to be one of the principal causes of secondary~     hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis~     and treatment is crucial in the management of such patients.The treatment of the sHPT of~     CKD's patient includes dietary phosphate restriction, the use of phosphate binders,~     correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic~     agent cinacalcet hydrochloride may be also used in combination with vitamin D. While the~     majority of patients can be controlled in this way, medical therapy is not always successful~     in achieving adequate control of secondary hyperparathyroidism. Oral medications~     (calcimimetics, recently developed phosphate binders, and active vitamin D derivatives~     amount to very high monthly costs, and have efficacy limitations as well as side-effects.~      HIFU may become a valuable alternative treatment that help control secondary~     hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s)~     visible at ultrasonography,.~      The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic~     haemodialysis patients with secondary hyperparathyroidism presenting with enlarged~     parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has~     been unsuccessful.~   "
124855|NCT01421394|"~     This prospective study will assess thoroughly functional deficits and their significance in~     the light of rehabilitation in spinal cord injured patients.~   "
124856|NCT01421381|"~     This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare~     this with the last visit from the SNT-II-003 study.~   "
124857|NCT01421368|"~     The purpose of the study is to examine the effects of two contraceptive methods and the~     menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect~     of the contraceptive methods on markers of mucosal safety.~   "
124858|NCT01421355|"~     Specific Aim: To establish the feasibility of studying the change in endothelial function~     caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that~     inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia.~     Endothelial function will be measured before and after atazanavir therapy. In addition,~     plasma markers of antioxidant capacity and oxidant stress will be measured as~     proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative~     stress in type 1 diabetes.~   "
124859|NCT01421342|"~     The overall purpose is to determine research based 'next-steps' for outpatients with major~     depressive disorder who have not had satisfactory outcomes to standard 'first-step'~     treatments. The primary objective is to compare the acute (up to 12 weeks) treatment~     effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-SR vs.~     switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major~     Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on~     antidepressant (SSRI or SNRI or mirtazapine) monotherapy. The secondary objectives are to~     compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects~     on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs~     and cost-effectiveness of each of the three treatments.~   "
124860|NCT01421329|"~     The investigators propose that healthy behaviors such as exercise could be increased through~     interactive interventions and weigh-ins (ie weekly emails, questionnaires, weigh-ins, and~     pay for participating in a study).~   "
124861|NCT01421316|"~     Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this~     limited survival it is important to consider quality of life (QOL) when treating these~     patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT~     itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in~     patients with brain metastases. Both fatigue and hair loss were reported to have the largest~     decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung~     cancer. Recent technological improvements in patient positioning and treatment planning will~     allow us to treat the whole brain with reduced margins, allowing better sparing of the~     scalp. In view of the large impact of hair loss on quality of life, the investigators~     hypothesize to see an improved quality of life with scalp sparing techniques.~      Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent~     clinically important improvement in QOL.~   "
124862|NCT01421303|"~     Patients with Ankylosing spondylitis more frequently discontinue work. This study measures~     the impact of Enbrel on work participation.~   "
124863|NCT01421290|"~     The hypothesis of this study is to investigate whether surgical intervention is necessary~     for patients who suffer from cartilage lesions of the knee, or whether this surgical~     intervention can be avoided or postponed by using conservative treatment options such as~     physiotherapy, nutrition supplements, intra-articular injections, bracing.~      Forty patients suffering from cartilage lesions in their knee joint will be selected~     preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They~     will be asked to respond to 3 different questionnaires. These questionnaires include the~     visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome~     Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the~     effect of their cartilage lesion on activities in daily life. Six months later +/- 20~     patients will have had surgery and +/- 20 patients will have had conservative treatment,~     both groups of patients will be asked to respond again to the 3 different questionnaires.~     The outcome of the results will tell us more of the evolution both between groups and in~     each group separately.~   "
124864|NCT01421277|"~     This study will describe the reasons for triptan utilization patterns (continuation and~     discontinuation) in triptan-naïve participants and assess the stability of treatment~     utilization patterns over time according to standard medical guidelines or clinical practice~     standards of the investigating physician.~   "
124865|NCT01421264|"~     In this open-label, pilot study the investigators will be assessing gabapentin's effects on~     insomnia and other concussion-related symptoms in patients with a recent concussion~     experiencing insomnia.~   "
124867|NCT01421238|"~     The purpose of this study is to study how people make decisions regarding delivery room~     management for infants born extremely premature when survival and long term outcomes are~     uncertain. The hypothesis is that the way in which information is presented will impact~     decisions.~      There have been many advances in neonatal care in recent decades. However, the investigators~     do not know if these children will grow up to be healthy or if they will have problems with~     mental retardation, behavior or physical handicaps. In these circumstances, where the~     medical profession cannot predict what sort of life a child will have, parents have a choice~     of having intensive care started or of allowing the baby to die naturally. The age most~     often cited by physicians at which this care is optional and under parental discretion is 23~     weeks gestation.~      The purpose of this study was to ask people, recruited through the world wide web, what they~     would want for the doctor to do in the case of a hypothetical 23 week premature delivery in~     order to evaluate the decision process and the presence of autonomous choice. This study had~     two parts. The first part, presented outcome information in 2 different ways -either as~     survival and lack of severe disability or as mortality and presence of severe disability.~     The results of the first part have been published (Message Framing and Perinatal Decisions,~     Pediatrics, 2008). The second part, investigated whether the way in which the way in which~     delivery room management options were presented- either as agreeing with a course of action~     or opting out- impacted resuscitation decisions. This part was administered as a separate~     survey to a different sample of participants at a later date. The remainder of the~     questionnaires asked demographic and opinion questions as a means to assess variables that~     may influence how people respond to the information they receive.~   "
124868|NCT01421225|"~     The investigators are conducting this study to find out whether a new device can control~     blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have~     high blood sugar levels because they do not make enough insulin. The standard treatment is~     to give insulin either by shots or using an insulin pump. A new device, called closed-loop~     insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a~     computer. The CGM will send the sugar levels to a computer which automatically figures out~     how much insulin to give and then gives that amount of insulin through the insulin pump. It~     will give the child insulin to bring sugar levels down if they are high, and will give less~     insulin if the child's blood sugar is getting lower. Earlier research using closed-loop~     insulin therapy has shown the ability for it to improve diabetes care in adults and older~     children, but there has been no research of closed-loop insulin therapy in young children.~     This study will compare children's current insulin therapy with the closed-loop system. The~     knowledge that the investigators gain from this research will help us to figure out whether~     closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes~     care.~   "
124869|NCT01421212|"~     The purpose of this study is to find the best monthly dose schedule for the new Hepatitis~     Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent~     Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to~     prevent hepatitis B reinfection following liver transplantation in patients with end stage~     liver failure due to hepatitis B infection.~   "
124870|NCT01421199|"~     The study has three objectives:~        1. To determine if the device can detect if middle ear fluid is present in children who~          are scheduled for tube placement (myringotomy)~        2. If fluid is present to characterize the fluid as thick or thin~        3. Evaluate the safety of the device~   "
124871|NCT01421186|"~     This is an open-label, multicentre, dose escalation study to characterize the safety and~     preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects~     with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with~     relapsed/refractory multiple myeloma in combination with standard therapy.~   "
124872|NCT01421173|"~     The goal of this clinical research study is to find the highest tolerable dose of vorinostat~     that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant.~     Researchers also want to learn about the safety and level of effectiveness of this~     combination.~      Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic~     material of cells), which may cause cancer cells to die.~      Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells~     to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not~     allowing these cells to repair the DNA damage caused by busulfan or melphalan.~      Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to~     DNA, such as gemcitabine, busulfan and melphalan.~   "
124873|NCT01421160|"~     This study aims to determine the causal relationship between regulating urine pH levels~     between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that~     maintenance of an alkaline urinary pH will result in a decrease in personally reported~     levels of chronic joint pain using a citrate treatment regimen.~   "
124874|NCT01421147|"~     The purpose of this study is to compare the effectiveness and safety of LY2963016 versus~     Lantus when taken once daily in combination with insulin lispro before meals three times a~     day.~   "
124875|NCT01421134|"~     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with~     mixed features.This clinical study is designed to test how well Lurasidone works to treat~     major depressive disorder with mixed features.~   "
124876|NCT01421121|"~     A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and~     immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.~   "
124877|NCT01421108|"~     This study explores the effectiveness of message framing, loss-framed vs. gain-framed~     messages on oral health in Iran.~   "
124887|NCT01420978|"~     When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often~     develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the~     brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to~     drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a~     patient does not tolerate this and a permanent surgery needs to be done to internalize a~     shunt.~      Though this is done commonly and routinely throughout the world, there are no good studies~     to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a~     level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which~     will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve~     perfusion at the level of the microcirculation in the brain, and result in improved~     neurologic outcomes.~   "
124912|NCT01420653|"~     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are~     greater than acetaminophen, ibuprofen or placebo.~   "
124913|NCT01420640|"~     The investigators will conduct a large randomized controlled trial comparing the~     effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for~     fibromyalgia. In addition, the investigators will determine the optimal frequency and~     duration of a Tai Chi intervention for short and long-term effectiveness.~   "
124878|NCT01421095|"~     Young adult cancer survivors constitute an under served population to whom fertility~     potential is particularly important. For female young adult patients, cancer treatment such~     as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in~     risks of infertility and premature menopause related to ovarian failure. Reproductive issues~     are a major concern for young cancer survivors, but one that is understudied. Young cancer~     survivors have few tools to measure post-treatment ovarian reserve, or the quantity and~     quality of remaining eggs4. Accurate determination of ovarian reserve and fertility~     potential would not only be an important research tool, but also directly impact clinical~     management. The purpose of this study is to test if basal and provocative ovarian reserve~     testing can predict return of menses in female young adult cancer survivors, to compare~     basal and provocative ovarian reserve testing results between female young adult cancer~     survivors and healthy controls, and to compare basal and provocative ovarian reserve testing~     results between female young adult cancer survivors on and off of combined estrogen and~     progesterone hormone products.~      Participants will be asked to keep track of their periods over three months. If a~     participant is taking birth control pills, patches, or vaginal ring, they will asked to come~     off the birth control for 3 months. Participants will also be asked to undergo ovarian~     reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.~   "
124879|NCT01421082|"~     The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality~     of life, exercise capacity, and static lung volumes, in patients with emphysema. The~     mechanism of action for these effects is believed to be related to the restoration of~     elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this~     study is to evaluate several physiologic parameters which should provide measures directly~     related to the mechanism of action by which the coils produce these outcomes.~   "
124880|NCT01421069|"~     This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3~     subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis~     related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96~     weeks of participation in study 0881A1-3338 (B1801014). The study contains an active~     treatment period, withdrawal/re-treatment period and a observational period (non-treatment).~   "
124881|NCT01421056|"~     The purpose of this study is to evaluate the safety and tolerability of ascending oral doses~     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.~   "
124882|NCT01421043|"~     This study will determine whether an oral drops formulation of triazolam at a dose of 0.25~     mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.~   "
124883|NCT01421030|"~     This study compares clinical, self- reported and cost outcomes in children and adolescents~     treated with pulmonary valve implantation, percutaneous versus open surgical technique.~     Since cardiac surgery in children and adolescents affect the whole family, the experience of~     the patients and their closest relatives are recorded and analysed separately. Cost may be~     an important factor in the choice of technology (1). Hence, the present study also aims to~     compare savings in costs, percutaneous versus open technique, related to the individual,~     their family and society.~      1.2 Research questions~        1. Percutaneous pulmonary valve implantation or open heart surgery; what are the patients'~          and their closest relatives narrative experiences~        2. Is there a difference in patient and their closest relatives reported outcomes,~          measured as health related quality of life, in patients with congenital pulmonary~          disease before the event, 1, 3, 6 and 12 months after percutaneous intervention versus~          open heart surgery approach?~        3. What is the relationship between patient reported outcomes and clinical outcomes~          before, 1, 3, 6 and 12 months after the treatment?~        4. Are there savings in costs related to the individual and their family and society~          between the two techniques?~   "
124884|NCT01421017|"~     This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and~     test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and~     radiotherapy (RT) in patients with skin metastases from breast cancer in the second part~     (Phase II). Currently this trial is in its Phase II part.~   "
124885|NCT01421004|"~     This is a multi-center, open-label, two way crossover study designed to test the~     bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients~     with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate~     that those 2 formulations are considered to be the same for all intents and purposes by~     making sure they are acting on the body with the same strength and are absorbed in similar~     amounts by the body. During the bioequivalence phase, patients will take orally at a daily~     dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days~     on/2days off dosing schedule, after which time, patients will switch to the alternate~     formulation for one additional week. After the bioequivalence phase, all patients may~     continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until~     disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or~     discontinuation from the study treatment for any other reason.~   "
124886|NCT01420991|"~     Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year,~     40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die~     do so before reaching the hospital. Most commonly, SAH results from rupture of an~     intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk~     and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public~     health problem with high lethality. Current estimates are that ruptured aortic aneurysm~     kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from~     aortic aneurysm rupture but a high proportion of those who die did not have a diagnosis of~     aortic aneurysm prior to rupture.~      The relationship between intracranial and aortic aneurysm has long been recognized, but~     poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular~     biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers~     increased risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along~     with linkage data for other susceptibility loci, indicate that individuals and families~     harboring one type of aneurysm may be at especially increased risk of the other.~      The rationale for this project is that opportunistic screening for abdominal aortic~     aneurysms (AAA) may be warranted in patients who present with aneurysmal subarachnoid~     hemorrhage. This study is meant to see if the yield of screening in this population is too~     low to justify its routine use. The investigators plan to systematically screen for AAA in~     all cases of aSAH presenting to MCH for treatment. If no individual out of 81 consecutively~     screened cases of aSAH has evidence of AAA, then the investigators can have strong~     confidence that there is a less than 5% chance of finding an AAA in the patient population.~   "
124914|NCT01420627|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of~     EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated~     with Adagen.~   "
124888|NCT01420965|"~     Background:~      - Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a~     person with prostate cancer and treats them in the laboratory. Then it returns the cells to~     the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the~     drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug~     cyclophosphamide will also be given, either before or after the cells are collected at the~     start of the treatment.~      Objectives:~      - To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate~     cancer.~      Eligibility:~      - Men at least 18 years of age who have advanced prostate cancer.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  This study has two parts, with different participants in each part. All participants~          will be monitored with frequent blood tests and imaging studies.~        -  Part I:~        -  Participants will provide cells for the Sipuleucel-T treatment three times. The first~          time will be 3 days before the chemotherapy. The second time will be 10 days after~          chemotherapy. The third time will be 24 days after chemotherapy.~        -  Participants will have one dose of cyclophosphamide the day before the first dose of~          Sipuleucel-T.~        -  Participants will have Sipuleucel-T about 3 days after each cell donation.~        -  Part II:~        -  Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or~          given with both cyclophosphamide and CT-011.~        -  Participants will provide cells for the Sipuleucel-T treatment three times, as in Part~          I.~        -  Participants will have Sipuleucel-T about 3 days after each cell donation, and will~          receive treatment with the other drugs as directed by the study doctors.~   "
124889|NCT01420952|"~     Background:~      - (11C)mGlu1 is a new drug that helps to show where a protein, mGluR1, is found in the~     brain. The drug contains a small amount of radioactivity that can be detected by imaging~     studies like positron emission tomography (PET) scans. By looking at the mGluR1 receptors,~     researchers hope to better understand how they are involved in general health, brain~     disorders, and addiction.~      Objectives:~        -  To test how (11C)mGlu1 is distributed in the brain and body.~        -  To measure how mGluR1 receptors display (11C)mGlu1 during imaging studies.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and~          urine tests. This study requires four visits to the NIH Clinical Center.~        -  Participants will have an initial evaluation, a magnetic resonance imaging (MRI) scan,~          a PET scan, and a final blood sample after the PET scan, all at different visits.~        -  The MRI and PET scans will focus on the brain. Participants will receive (11C)mGlu1,~          and have scans to see how it shows up in the brain.~        -  Some participants will have whole body imaging studies to see how (11C)mGlu1 shows up~          in the body.~   "
124890|NCT01420939|"~     Background:~      - A person who has a traumatic brain injury (TBI) -- also called concussion -- can have~     serious and long-lasting effects. Doctors who treat TBI need more information about how the~     brain changes over time in people with TBI and how well a person recovers from it. To make~     existing TBI treatments more effective and develop new ones, researchers want to look more~     closely at how TBI affects people both physically and psychologically.~      Objectives:~      - To collect medical information from people with recent traumatic brain injury and compare~     this information to that of healthy volunteers and of persons who have had injuries to other~     parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after~     surgery).~      Eligibility:~      3 groups of people between the ages of 18 and 70 years will be asked to take part.~        -  Persons who have had a traumatic brain injury (or concussion ) within the past 30 days,~          OR~        -  Persons who are healthy and have never had a traumatic brain injury, OR~        -  Persons who have had an injury within the past 30 days to a part of their body other~          than the head (such as a broken bone, orthopedic injury, surgery)~      Design:~        -  This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be~          about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit~          within 30 days of their injury.~        -  Screening: Participants will be screened with a medical history, physical examination,~          blood tests and electrocradiogram (ECG a routine heart test).~        -  The research will involve:~             1. Giving blood samples (no more than 75 ml each visit).~             2. Having tests of memory, attention, concentration, and thinking (neuropsychological~               testing).~             3. Having imaging studies of the head including magnetic resonance imaging (MRI) and~               positron emission tomography (PET) scans.~        -  Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and~          persons with non-TBI injuries will have the same tests at Visit 1 as listed above. But,~          at Visit 2, they will not have brain MRIs or PETs.~        -  No treatments will be provided as part of this research protocol.~   "
124891|NCT01420926|"~     This randomized phase II trial studies how well giving decitabine with or without bortezomib~     works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy,~     such as decitabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether decitabine works better when given with or without bortezomib in treating acute~     myeloid leukemia.~   "
124892|NCT01420913|"~     The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A,~     YHD1119 B, YHD1119 C and Lyrica capsule.~      YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.~      Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity,~     T max,ss, t 1/2~   "
124893|NCT01420900|"~     The investigators want to examine if specific acetabular liner designs can be a contributing~     factor to audible squeaking associated with CoC bearings. The aim of the present study is to~     compare two different designed and well documented acetabular component systems with~     reference to squeaking and other noises from the hip.~   "
124894|NCT01420887|"~     This pilot study is designed to determine if the rehabilitative benefits of continuous~     passive motion (CPM) will help preserve/restore the joint function and significantly improve~     the rate of recovery of patients after the surgical release of elbow contractures better~     than standard physiotherapy and static splinting.~   "
124895|NCT01420874|"~     The purpose of this research study is for the participant to give their own T cells (a type~     of blood cell in the body that can fight infections and possibly cancer) to them after they~     have been removed, grown in a lab, and then coated with an experimental drug.~      This study will determine the highest dose of EGFR2Bi coated T cells that can be given~     without causing severe side effects. Initially a group of 3 participants will receive the~     same dose of study drug. If no serious side effects occur, the next group of participants~     will receive a slightly higher dose of study agent. The following groups of participants~     will receive higher doses of the study drug until a dose is reached where there are~     unacceptable side effects and maximum tolerated dose is found, or the planned highest dose~     level is reached with no side effects.~   "
124896|NCT01420861|"~     The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific~     antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on~     androgen deprivation therapy (Serum PSA response and Serum PSA progression)~   "
124897|NCT01420848|"~     Single-blind randomized controlled trial aimed to assess stress and anxiety levels in~     Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of~     true and placebo auriculotherapy.~   "
124898|NCT01420835|"~     The purpose of this study is to assess stress levels and quality of life in the nursing team~     of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with~     and without closed protocol on reducing the stress levels and improvement of life quality.~   "
124899|NCT01420822|"~     This post-marketing surveillance study is to investigate possible problems or questions in~     safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with~     allergic rhinitis under the conditions of actual practical use.~   "
124901|NCT01420796|"~     Parkinson's disease (PD) is a chronic, degenerative disease described by motors and~     non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of~     tracheal aspiration largely responsible for increased morbidity and mortality in this~     population. Thus, interdisciplinary rehabilitation strategies can reduce the complications~     of dysphagia, with consequent improvement of the prognosis of individuals with PD.~     Objective: To determine the impact of combined oral motor exercises and breathing exercises~     on swallowing disorders in individuals with PD. Method: Clinical trial, randomized and~     blinded for the examinator. For all subjects will be given the stage of PD and applied~     quality of life questionnaire. The swallowing complaints will be investigated through~     structured questionnaire and functional aspects of swallowing with videofluoroscopy. The~     Manovacuometry Spirometry will determine measures of respiratory function. The assessment of~     vocal and speech disorders will be done with perceptive, acoustic, aerodynamic and~     electroglottographic measures as well as analysis of intelligibility. Three groups of~     intervention will be defined: one of them doing oral motor exercises for swallowing, one~     doing breathing exercises and another must do this two interventions combined. Effect of~     intervention will be assessed through measures of swallowing, breathing, voice and speech.~     The groups will be compared, according to the principle of intention to treat by~     appropriate statistical tests, according to the distribution of the dependent variables.~   "
124902|NCT01420783|"~     Primary Objective:~        -  Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400~          mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea~          (per European LeukemiaNet criteria) for :~             -  Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3~               months in patients with polycythemia vera, and~             -  Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients~               with essential thrombocythemia.~        -  PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate~          the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or~          intolerant to hydroxyurea (per European LeukemiaNet criteria) for:~             -  Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and~               continuing through Day 1 of Cycle 6 visit in patients with PV, and~             -  Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit~               and continuing through Day 1 of Cycle 6 visit in patients with ET.~      Secondary Objectives:~        -  To evaluate the safety of SAR302503.~        -  To evaluate the efficacy of SAR302503 in patients with PV who are resistant or~          intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.~        -  To evaluate the efficacy of SAR302503 in patients with ET who are resistant or~          intolerant to hydroxyurea for reduction of platelet counts.~        -  To evaluate the efficacy of SAR302503 in inducing complete and partial responses~          beginning at Day 1 of Cycle 6 visit through Cycle 8.~        -  To evaluate splenic response as measured by spleen volume using MRI or CT.~        -  To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.~        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F~          allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation~          inhibition.~        -  To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated~          symptoms, as well as overall impact on quality of life.~        -  To measure generic health-related quality of life and utility value using the EuroQol~          Group (EQ-5DTM) questionnaire.~   "
124903|NCT01420770|"~     Primary Objective:~      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 for~     the reduction of spleen volume as determined by magnetic resonance imaging (MRI).~      Secondary Objectives:~        -  To evaluate the safety of SAR302503.~        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat doses.~        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F~          allele burden in those patients with JAK2V617F mutation, changes in substrate~          phosphorylation in the JAK-STAT signal transduction pathway, and the expression of~          cytokines.~        -  To measure improvement in baseline Myeloproliferative Neoplasm (MPN) associated~          symptoms, as well as overall impact in quality of life (QOL), through serial~          administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).~        -  To measure generic health-related quality of life (HRQL) and utility values using the~          EQ-5D questionnaire.~   "
124904|NCT01420757|"~     Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up~     to 54%. If a mesh is used, the defect can be closed tension-free. Using this method,~     recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is~     a relatively new technique in which the mesh is positioned intraperitoneally. Research has~     shown that this procedure is technical feasible and may have benefits for the patients.~      The ongoing debate about the merits of endoscopic versus open incisional hernia repair~     prompts the need for a level 1 randomized controlled trial.~   "
124905|NCT01420744|"~     The purpose of this study is to determine whether the adjunctive therapy to standard~     antibiotic treatment of BT086 is safe and effective of decreasing the days patients require~     endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).~   "
124906|NCT01420731|"~     Back pain is a common hormonal disorder in men that may affect the phases of male sexual~     function. The investigators investigated sexual function in male patients with back pain.~      A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the~     as control group were evaluated with a detailed medical and sexual history, including a~     international erectile function index (IEFI) questionnaire and the Beck Depression~     Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone,~     androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were~     measured. These variables were compared statistically between the 2 groups.~   "
124907|NCT01420718|"~     The purpose of this study is to compare the human pulp response to partial pulpotomy using~     White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.~   "
124908|NCT01420705|"~     The prevalence of asthma and allergic diseases is increasing worldwide. Infections and~     vaccinations in childhood may have an impact on the subsequent development of asthma and~     allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin~     (BCG) vaccine was associated with reduction in atopy. Since then the investigators have~     conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The~     present study aims to follow up children enrolled in the BCG randomised trial to assess for~     asthma and allergy later in childhood. Based on previous observations, the investigators~     expect children allocated to receive BCG at birth will have a reduction in allergy profile~     when compared to children who did not receive BCG at birth.~   "
124909|NCT01420692|"~     The main purpose of this study is to analyze the effects of the addition of sulfonylurea~     (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style~     modification and metformin treatment as a second step treatment in type 2 diabetes mellitus~     on endothelial cell functions. The second goal is to identify the effects of these treatment~     alternatives on body-mass index, the changes in body fat mass, insulin resistance and on the~     insulin secretion capacity of beta cells. The third aim of this study is to determine the~     success rates of these treatment alternatives on glycemic control at 6 months follow-up.~   "
124915|NCT01420614|"~     Prospective, randomized, multi-center trial comparing the safety and efficacy in the~     prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach~     for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing~     primary angioplasty~   "
124917|NCT01420588|"~     The investigators study the feasibility of a novel method in oncology based on breath~     analysis with a nanosensors array for identifying gastric diseases. Alveolar exhaled breath~     samples collected from volunteers referred for upper endoscopy or surgery are analyzed using~     a custom-designed array of chemical nanosensors based on organically functionalized gold~     nanoparticles and carbon nanotubes. Predictive models are built employing discriminant~     factor analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and~     specificity are determined using leave-one-out cross-validation or an independent blind test~     set. The chemical composition of the breath samples is studied using gas chromatography~     coupled with mass spectrometry (GC-MS).~      A pilot study is conducted first (enlistment of 160 subjects at the Department of Oncology,~     The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of~     Anhui Medical University, Hefei, Anhui, China.)~      The pilot study is followed by a large-scale clinical trial to confirm the preliminary~     results of the Chinese pilot study (enlistment of 800 subjects at the Digestive Diseases~     Centre GASTRO, Riga East University Hospital, 6 Linezera iela, LV1006 Riga, Latvia). 25% of~     the samples are used as independent blind test set. The samples are blinded by the medical~     team and are not disclosed until prediction of blind sample identity is complete.~   "
124918|NCT01420575|"~     We hypothesize that the use of a visual decision aid tool to educate patients regarding~     potential harm with respect to weight gain with olanzapine versus perphenazine can lead to~     better shared decision making by patients, increase rates of antipsychotic switches and~     promote weight loss in overweight patients with schizophrenia/schizoaffective disorder.~      Our specific aims are the following:~        1. To investigate the effects of a visual decision aid, versus care as usual, on patients'~          perceived difficulties in medical decision making regarding switching antipsychotics in~          overweight veterans with schizophrenia or schizoaffective disorder.~        2. To investigate the effects of a visual decision aid and a shared decision making model~          on rate of medication switches (from olanzapine to perphenazine) in overweight veterans~          with schizophrenia or schizoaffective disorder.~        3. To investigate the effects of a visual decision making aid and shared decision making~          model on BMI in overweight veterans who switch from olanzapine to perphenazine therapy.~   "
124919|NCT01420562|"~     The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough~     levels of posaconazole reached in patients with different stages of mucositis, due to~     chemotherapy and total body irradiation.~   "
124920|NCT01420549|"~     The purpose of this study is to determine the non-inferiority between two different FDC,~     measuring LDL-Cholesterol levels, in high risk patients by NCEP-ATP III, with primary~     hypercholesterolemia or mixed dyslipidemia.~   "
124921|NCT01420536|"~     The objective of this study is to compare the canine guidance (CG) and bilateral balanced~     occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture~     wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and~     mandibular complete dentures and, after the intraoral adjustments and adaptation period,~     will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by~     BBO.~   "
124922|NCT01420523|"~     Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with~     virological success, presenting with clinical lipohypertrophy.~   "
124923|NCT01420510|"~     We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the~     incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.~   "
124924|NCT01420497|"~     Several studies have shown that in diabetic patients, the glycemic profile was disturbed~     after intra-articular injection of corticosteroids. Little is known about the impact of~     epidural injection in such patients. The goal of this study was double, at first comparing~     the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate~     methylprednisolone either intra-articular or epidural, secondly to compare the amount of~     systemic diffusion of the drug the after both procedures.~   "
124925|NCT01420484|"~     The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with~     pronounced variation of arterial pressure will be assessed under analgosedation.~      Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP~     undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic,~     and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data~     will be analysed in different periods of arterial pressure for agreement of the two methods~     and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic~     error). Additionally, we will compare both methods regarding the amplitude and time of very~     fast changes in arterial pressure during intervals of functional cardiac arrests (rapid~     pacing).~   "
124926|NCT01420471|"~     All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy~     the inclusion/exclusion criteria will be included in the study.~      All patients enrolled in this study will have spacers (impregnated with saline or~     Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as~     their own controls. Nostril's will be randomized to either the experimental treatment~     (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer).~     These spacers will be removed after 6-days post-op.~      Participants will undergo the standard post-operative endoscopic sinus surgery follow-up~     appointments plus one additional research visit (not standard of care). This includes~     follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the~     post-operative period. During these appointments, the surgeon will assess the post-operative~     mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be~     administered, as per standard protocol, at each post-op follow up visit.~      Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up~     appointments for analysis.~      Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in~     a perforated glove finger improves patient outcomes, wound healing and reduces inflammation~     compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS~     patients receiving FESS.~      Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard~     saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.~   "
124927|NCT01420458|"~     This is an open-label, single-center, 2 period crossover, PK profile study. Each subject~     will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled~     concurrently.~   "
124928|NCT01420445|"~     The study will conduct with 4 comparative groups orally treated with YHD001 dose level~     1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo~     for 7 days.~      The treatments will be assigned randomly to patients (n=116) with acute or chronic~     bronchitis.~   "
124929|NCT01420432|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for~     the therapy of Ankylosing spondylitis (AS)~   "
124930|NCT01420419|"~     The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of~     painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has~     an effect on breastfeeding outcomes such as duration and exclusivity.~   "
124931|NCT01420406|"~     The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and~     beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol~     concentrations in lactating Bangladeshi women.~   "
124932|NCT01420393|"~     Atrial fibrillation and heart failure are two common heart conditions that are associated~     with an increase in death and suffering. When both of these two conditions occur in a~     patient the patient's prognosis is poor. These patients have poor life quality and are~     frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure~     patients is extremely challenging. Two options for managing the atrial fibrillation are~     permitting the atrial fibrillation to continue but controlling the heart rate, or to convert~     the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm.~     Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic~     drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival~     benefit when compared with permitting the patient to be in atrial fibrillation. In the last~     few years, new development in techniques and technologies now enable catheter ablation~     (cauterization of tissue in the heart with a catheter) to be a successful treatment in~     abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to~     control the rhythm. However, there has not been any long-term study to determine whether~     catheter ablation to abolish atrial fibrillation in heart failure patients would reduce~     mortality or admissions for heart failure.~      This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm~     control to rate control in patients with heart failure and high burden atrial fibrillation~     on the composite endpoint of all-cause mortality and hospitalization for heart failure~     defined as an admission to a health care facility for > 24 hours. The investigators will~     also be assessing the cost-effectiveness of this treatment strategy and the life quality for~     these patients. This study may have a dramatic impact on the way the investigators manage~     these patients with atrial fibrillation and heart failure and may improve the outlook and~     well being of these patients.~   "
124933|NCT01420367|"~     Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime~     in preventing post-operative complications in paediatric patients with simple appendicitis.~      This project will compare patients 16 years and under with simple appendicitis (appendicitis~     that is not perforated or gangrenous). Patients will be randomly divided into two groups;~        -  Group one will receive a single pre-operative dose of antibiotics (metronidazole~          12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline~          (placebo) eight and sixteen hours after the initial dose, respectively.~        -  Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg~          up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and~          sixteen hours after the first dose, respectively.~      Group allocation will be concealed from the patient and their guardian, the treating~     surgical team and outcome assessors (triple blinded). A process to rapidly reveal group~     allocation if required will be in place.~      The aim of the study is to determine if a single dose of antibiotics is as effective as~     three doses in preventing post-operative infection. This will be assessed by comparing:~        -  Duration of hospital stay from operation until discharge, based on a standardised~          discharge criteria.~        -  Development of wound infection or requirement of antibiotics in the six weeks~          post-operation~        -  Need for re-admission.~      Information will be collected prospectively from each patient's hospital notes and from a~     follow-up phone call six weeks after the operation.~   "
124934|NCT01420354|"~     This study will sought to determine if limited urine collections can provide similar or more~     informative data than standard 24-hour urine collections used to evaluate kidney stone~     formers.~   "
124935|NCT01420341|"~     This is a randomised, open-labelled, controlled trial to compare the efficacy and~     effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of~     melioidosis. The study population includes 800 patients with culture-confirmed melioidosis~     whom intravenous intensive antibiotics and 12 weeks of oral eradication therapy have been~     completed. Patients will be randomised to either stop the eradication treatment or continue~     current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat~     melioidosis for better compliance and reducing unnecessary use of antibiotics.~   "
124936|NCT01420328|"~     This study focuses on the use of Vytorin to study inflammatory markers in subjects with~     normal cholesterol.~   "
124937|NCT01420315|"~     Recent studies indicate that there is a relationship between cognitive decline and vitamin D~     deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in~     patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D~     deficiency and analysis the associated characteristics in patients with Alzheimer's disease.~   "
124938|NCT01420302|"~     The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed~     protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients~   "
124939|NCT01420289|"~     To evaluate the effects of HPIPC for the treatment of symptoms of PAD~   "
124940|NCT01420276|"~     Back paın is a common hormonal disorder in women that may affect the phases of female sexual~     function (FSD). We investigated sexual function in patients with back paın A total of 54~     women with back paın and 27 age matched voluntary healthy women who served as the as control~     group were evaluated with a detailed medical and sexual history, including a female sexual~     function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin,~     dehydroepiandrosterone sulfate, free testosterone, androstenedione,~     17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These~     variables were compared statistically between the 2 groups.~   "
124941|NCT01420263|"~     The purpose of this study is to determine whether re-feeding of gastric residuals reduces~     the time needed to establish full enteral feedings in premature infants. Infants with~     gestational ages 23-28 weeks at birth will be randomized within one week to receive either~     gastric residuals or fresh formula or breastmilk whenever significant residuals during~     feeding advancement require clinical assessment for continuing feedings. Primary outcome~     measure is time to establish full enteral feedings (120cc/kg/day).~   "
125193|NCT01417000|"~     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with~     cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide)~     alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.~   "
124942|NCT01420250|"~     This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with~     concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation~     therapy that uses computer-generated images to show the size and shape of the tumor. Thin~     beams of radiation of different intensities are aimed at the tumor from many angles.) and~     androgen deprivation therapy (Treatment to suppress or block the production or action of~     male hormones) in patients with locally advanced prostate cancer.~      It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control~     can be achieved and eventually the cure rate can be increased. After this study, the~     maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can~     be found.~      Men with locally advanced high risk prostate cancer represent a group of patients for whom~     cure is potentially achievable utilizing a multimodality approach. More aggressive treatment~     upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize~     that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel~     approach will improve disease control and eventually improve survival for locally advanced~     prostate cancer patients.~   "
124943|NCT01420237|"~     The purpose of this study is to evaluate the success rate of cementless primary hip~     replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip~     systems in the literature, through absence of femoral head dislocation at 10 years~     postoperative.~   "
124944|NCT01420224|"~     The study hypothesis is that commercial air travel causes an increase in the blood pressure~     in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable~     echocardiography (heart ultrasound) now offers a non-invasive means of studying this~     in-flight.~   "
124945|NCT01420211|"~     The objective of the study is to assess the hepatic uptake of Primovist® after intravenous~     administration of 25 µmol/kg body weight in 56 healthy volunteers and in 60 patients with a~     liver disease in dependence on the OATP1B1- and OATP1B3-genotype.~   "
124946|NCT01420198|"~     An increasing proportion of Sweden's population comprises non-European immigrants, who~     constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi~     citizens represent the largest immigrant group in Malmoe and are identified as a risk group~     for Type 2 Diabetes (T2D) in whom genetic and lifestyle factors probably play significant~     roles in the development of T2D.~      Several studies have shown that adoption of an active lifestyle by at-risk individuals~     dramatically reduces the risk of T2D. However, there are currently no established methods~     for providing support to high-risk individuals from different cultural and social~     backgrounds to help them adopt beneficial lasting lifestyle changes. Instead of just waiting~     for Iraqi high-risk individuals to develop T2D, this project will implement and assess~     lifestyle intervention programs aimed at reducing the risk of developing T2D and tailored to~     individuals with a different social and cultural background.~      The study thus seeks to optimize preventive action in health care and aims to facilitate the~     adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural~     and social barriers.~      Since T2D is associated with a sedentary lifestyle and develops earlier in men than women~     and an average 10 years earlier in immigrants from the Middle East than in native Swedes, it~     is crucial to study pathogenic mechanisms triggering T2D development in relation to sex,~     lifestyle and ethnic background. The results will provide the basis for deciding how health~     care providers can actively work to prevent T2D and other lifestyle-associated diseases in~     this high-risk population that has not been studied before.~   "
124947|NCT01420185|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer. It may also help~     doctors predict whether cancer will come back after treatment.~      PURPOSE: This research trial is studying genes that may predict local recurrence in samples~     from patients with breast cancer. treated on NSABP-B-28~   "
124948|NCT01420172|"~     This will be a retrospective study and analysis of subjects who have undergone a~     hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC~     at any time between 01Jan2000 and 30Jun2011.~      This study will determine factors influencing pulmonary disease and associated treatment~     strategies.~   "
124949|NCT01420159|"~     This study investigates the treatment of acute pain, an unpleasant feeling caused by an~     injury. The overall purpose of the study is to gain more information that the pain relief~     medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive~     green, whistle like object that you breathe through) is safe and works at relieving pain in~     patients aged 12 years and older who are admitted to a hospital Emergency Department with a~     minor injury (known as trauma).~   "
124950|NCT01420146|"~     Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled~     trastuzumab.~   "
124951|NCT01420133|"~     Few recommendations concerning the diet and dosage to be administered to patients treated~     with corticosteroids are established.~      It therefore seems important to study prospectively the indication of a diet low in salt and~     sugar in patients undergoing corticosteroid therapy, to record side effects observed and to~     measure their frequency.~   "
124952|NCT01420120|"~     This is a prospective multicenter registry to evaluate safety and performance of the REMEDY,~     biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral~     arteries. Patients will be followed for a period of 1 year.~   "
124974|NCT01419834|"~     The purpose of this study is to find out if humanized 3F8 (Hu3F8) is safe for treating~     neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find~     out what side effects happen when higher and higher doses of a drug are used.~      The investigators want to find out what effects, good and/or bad, Hu3F8 has on cancer. The~     amount of Hu3F8 that patients gets will depend on when they start treatment on this study.~     The investigators also want to find out more about how Hu3F8 works and how effective it is~     in attacking the disease. Hu3F8 is an experimental drug, which means it has not yet been~     approved by the FDA for the treatment of this disease.~   "
124986|NCT01419678|"~     This is a single center, observational study of posaconazole PK sampling in lung transplant~     recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and~     one 10ml blood sample for a total collection of 28ml of blood obtained over the entire~     study. In addition, the investigators will collect medical record information and any excess~     BAL samples available during the study (tests done as part of the patient's clinical care~     and the samples would have been discarded once diagnosis was made).~   "
124953|NCT01420107|"~     A video of the delivery room management will be taken using standardized conditions. The~     video will be evaluated either locally by those directly involved in the delivery room care~     of this specific infant or anonymously at the main study center. Using a standardized~     evaluation form a set of predefined interventions is rated regarding at what time they took~     place and at what time they should have taken place. The difference in time for all~     interventions is summed up to a score. This score should allow to assess the delivery room~     management in comparison to the desired standard as well as between hospitals. The~     evaluation forms of all centers will be analyzed at the main study center to define~     correlations between certain delivery room interventions and short term outcome.~      Aim of the study is to~        -  gather data on how delivery room care is currently done,~        -  come closer to an agreement between different NICUs towards what should be done in the~          delivery room under what circumstances in which way,~        -  find those interventions with potential influence on short term outcome. Those aspects~          of management that are different between centers and show correlation with short term~          outcome will be the focus of future prospective intervention trials in order to find~          the best way how to take care of preterm infants in the delivery room.~      Hypothesis:~      In preterm infants <32;0 weeks of gestational age a correlation exists between specific~     delivery room interventions and short term outcome.~   "
124954|NCT01420094|"~     To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a~     single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000~     mg and placebo for relief of pain following extraction of impacted third molars.~   "
124955|NCT01420081|"~     This study will investigate the individual safety and efficacy of two dual PI3K/mTOR~     inhibitors in patients with recurrent endometrial cancer.~   "
124956|NCT01420068|"~     52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and~     development in pediatric hypertensive patients previously treated with aliskiren in studies~     SPP100A2365 and SPP100A2365E1~   "
124957|NCT01420055|"~     This is a prospective, open-label, multi-center phase IV study to assess response to~     fingolimod initiation according to coping profile in adult patients with highly active~     relapsing remitting multiple sclerosis in France.~   "
124958|NCT01420042|"~     The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics~     (PK) of NNZ-2566 in healthy volunteers, when administered orally.~   "
124959|NCT01420029|"~     In this observational pilot project, the investigators plan to document duration and sources~     of exposure to plasticizers in infants born at birth weights less than 1500 grams. The~     investigators will examine the association between exposure to plasticizers and outcomes~     such as performance on a neurological screening tool, extrauterine growth, and thyroid~     function.~   "
124960|NCT01420016|"~     The objective of this project is to develop and implement sophisticated point-of-care~     Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b)~     prioritizes all available evidence-based treatment options to reduce a given patient's~     cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the~     investigators will test its impact on CVR, the components of CVR, in a group randomized~     trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults~     with moderate or high CVR. This approach, if successful, will (a) improve chronic disease~     outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the~     clinical return on the massive investments that are increasingly being made in sophisticated~     outpatient EHR systems, and (c) provide a model for how to use EHR technology support to~     deliver personalized medicine in primary care settings~   "
124961|NCT01420003|"~     The purpose of this study is to characterize the time course of B cell activation after~     allergen challenge, and more specifically measure the M1 prime related biomarkers.~   "
124962|NCT01419990|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.~      During the course of the study, the amount of GLPG0634 present in the blood~     (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related~     parameters in the blood (pharmacodynamics) will be characterized.~   "
124963|NCT01419977|"~     Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and~     exhibits highest frequency in people of African descent. Patients with SCD currently have~     few treatment options, with hydroxyurea being the only medication approved to reduce the~     frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute~     chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no~     specific therapy is currently available to otherwise affect the course of the VOC. However,~     there has been increasing interest in the role of coagulation in the pathogenesis of SCD.~     The investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose~     low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive~     process and thereby hasten the resolution of pain.~   "
124964|NCT01419964|"~     This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel~     group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of~     achromatic areas in patients with vitiligo.~   "
124965|NCT01419951|"~     The objective of this project is to pilot test a behavioral intervention that includes a~     home visit component compared to a clinic only and standard of care for the treatment of~     obesity in preschool age children. The results of this study will inform the design of a~     larger randomized control trial.~      H1: The clinic + home intervention will result in a significantly greater decrease in BMIz~     compared to the in clinic only intervention or pediatric standard of care at 6 months~     post-treatment.~   "
124982|NCT01419730|"~     This research will examine the effectiveness of vitamin D or placebo (the placebo is a~     tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with~     and without physical activity (walking and progressive resistance exercise), in treating~     bone loss in women who have undergone treatment for breast cancer. The investigators would~     also like to find out if the physical activity program improves cardiovascular fitness,~     energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105)~     subjects are expected to take part in this study. The investigators don't know if bone loss~     in breast cancer survivors should be treated differently than bone loss in other women.~   "
124966|NCT01419938|"~     Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep~     disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian~     clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at~     night and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among~     young people between 16-25 years, which conveys that school attendance and education are~     affected, and also often results in severe social consequences. DSPS is sometimes associated~     with depression and personality disorders and may aggravate psychiatric symptoms.~      This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it.~     The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack~     of guidelines how often, with which wavelength, and how long the treatment of DSPS patients~     shall go on. Previous studies shows that light therapy often is effective. The effect gets~     even better if melatonin is administered concurrently. However, the frequency of relapse is~     high.~      Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal~     daytime functioning. There are almost no treatment options available in health care~     settings. There is a clear need for further studies on this topic. The main purpose of the~     present study is to evaluate the clinical effects of short and long-term treatment by using~     light therapy and cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate~     depression and anxiety. It also has some evidence in treating insomnia. Patients with DSPS~     often have al of these symptoms and therefore the investigators would like to investigate if~     CBT can enhance the effect of light therapy.~      Firstly, the investigators want to evaluate the short-term effects of light therapy with and~     without CBT. Secondly, the investigators want to evaluate if the patients who get CBT~     maintain a normal sleep rhythm and prevent relapse of DSPS compared to just light therapy~     for two weeks.~      The investigators also want to evaluate how this patient-group differs when it comes to~     behavioral factors compared to a matched reference group.~   "
124967|NCT01419925|"~     Multimeric-001 (M-001) has been recently developed, containing conserved, common linear~     influenza epitopes that activate both cellular and humoral arms of the immune system against~     a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an~     attractive candidate for priming immune responses to seasonal influenza vaccine in the~     elderly population. The current clinical study was designed to assess M-001's standalone and~     priming action in subjects over 65 years old.~      This is a second Phase II study comprising 120 participants. Eligible subjects were~     randomized to receive to receive either two sequential non-adjuvanted or a single~     non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment),~     or one placebo (saline) injection, before receiving the TIV.~   "
124968|NCT01419912|"~     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,~     inositols might have beneficial effects on controlling complication among diabetic~     nephropathy patients(DN).Most studies in this regard have been examined the effect of soy~     consumption on cardiorenal risk factors among patients with DN and there are few data about~     relationship of soy milk consumption and health effect in patients with DN . Therefore, we~     evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation,~     oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients.~     This was a cross-over randomized clinical trial which was conducted in Isfahan among~     diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing~     cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4~     weeks.~   "
124969|NCT01419899|"~     The purpose of this study is to determine if a brief intervention delivered to emergency~     department patients increases the uptake of rapid HIV and hepatitis C testing in comparison~     to no brief intervention.~   "
124970|NCT01419886|"~     Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence~     that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased~     risk for pneumonia in these patients versus similar patients without dysphagia. Patients~     with dysphagia also suffer poor nutrition and dehydration. Patients can become so~     malnourished that it slows their recovery. Dysphagia can cause choking when food or liquid~     enters the lungs. Over time, this will cause pneumonia and even death. More acutely,~     patients fear that their choking will cause them to suffocate and die. Over time, patients~     are embarrassed to be seen choking and thus feel forced to dine alone. These patients report~     feelings of isolation and depression. To date, there are no practical methods to assess~     these adverse outcomes of swallowing difficulties in patients. This research will be the~     first to address this gap. Specifically, as part of previous research (PhD dissertation by~     RM, the PI) a new measure of medical outcomes of dysphagia was developed, titled the Medical~     Outcomes of Dysphagia (MOD) scale. The MOD consists of 3 subscales that each measure lung,~     nutrition-hydration or psychological consequences in patients with swallowing difficulties.~     Unlike more expensive and complex tests, the MOD has been designed for both in- and~     outpatients. This research will validate each MOD subscale to ensure retention of only items~     that are reliable and valid for use with patients who have dysphagia due to any disease~     etiology. The final MOD subscales will be the first to allow clinicians to track medical~     complications in their patients and to ensure that treatment is effective. Globally, the MOD~     subscales will direct limited health care resources to the most effective treatments for~     swallowing disorders.~   "
124971|NCT01419873|"~     Very low birthweight neonates commonly develop high blood sugar levels. There is an~     association between high blood sugar levels and poorer short term outcomes but it is not~     known whether the high sugar level itself actually causes the problems.~      There are a range of ways to manage high sugar levels but there are no consensus guidelines~     to follow. One option is to manage the high sugar levels with an infusion of insulin.~     Studies looking at insulin infusions have often used fixed protocols to guide the amount of~     insulin to be given and are often complicated by hypoglycaemia.~      This study investigated whether using a model-based approach to individualise insulin~     administration to neonates with high sugar levels would provide a safe and effective~     management option for controlling blood sugar levels and avoid the complication of low blood~     sugar levels.~   "
124972|NCT01419860|"~     The aim of the study is to describe utility of dynamic fluorescence videoangiography of~     indocyanine green (ICG) in gastrointestinal surgery, for evaluation of microcirculation in~     colon wall and anastomosis before and after surgical resection; and if this technique can~     guide the surgeon to peroperative decision making considering recreate a new anastomosis or~     stoma for preventing anastomotic failure or stomia necrosis.~   "
124973|NCT01419847|"~     Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of~     onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior~     cost and safety profile compared to systemic therapy.~   "
124983|NCT01419717|"~     This trial will facilitate access of denosumab for subjects with advanced cancer who have~     participated in a denosumab phase 3 study until denosumab is approved and available for~     sale, or until another mechanism is identified to provide denosumab to ongoing subjects.~   "
124984|NCT01419704|"~     The goal of this research study is to establish chimerism and avoid graft-versus-host~     disease in patients with hemoglobinopathies.~   "
124975|NCT01419821|"~     Abstract Background: Vitamin D affects a wide variety of functions in the body including~     regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a~     high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe~     in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population~     drastically reduce sun exposure, known to encourage production of Vitamin D. Countless~     research has analyzed preterm as well as term neonates born to mothers with vitamin D~     deficiency, with regard to weight, height, and bone mineral density at birth. However, there~     is a paucity of information about healthy infants' vitamin D levels and its' correlation to~     these parameters during the first few years of life. Objectives: The purpose of the proposed~     study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end~     of the first year of life with growth rates and bone mineral density in the same children at~     the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the~     Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12~     months of age (when routine blood tests are normally drawn for these infants) and bone~     mineral density will be measured using Quantitative Ultrasound. Infants will be divided into~     2 groups: those with those with normal 25(OH)D levels (>15ng/ml), and those with 25(OH)D~     deficiency (<15ng/ml). Group 1- normal levels will receive no intervention. Infants with~     25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those~     receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for~     one year, or Group 3- those receiving the placebo. Height, weight, and head circumference~     growth curves will be recorded every two months until 2 years of age. Quantitative~     ultrasound, growth charts and blood tests including 25(OH)D, serum calcium and phosphate~     levels, Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12~     months will be repeated at 2 years of age. At that time children from Group 1 (no~     supplementation) will be divided into three: Group 1a- normal 25(OH)D levels will continue~     with no intervention, Group 1b <15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c~     <15ng/ml will receive a placebo until age three. Groups 2 and 3 will continue their previous~     treatment until age three. All aforementioned tests will be repeated at age 3, when~     treatment will stop, and the same tests will be repeated at age 5.~   "
124976|NCT01419808|"~     The purpose of this study is to investigate whether treatment of scaphoid non-unions with a~     vascularized bone grafts improves patient reported pain and disability compared to treatment~     with a non-vascularized bone graft. Secondary objectives are to examine if there is any~     difference in the overall rate and time to union, range of motion, grip strength, or~     complication rates between the two groups.~      In addition, this is the first prospective randomized study to directly compare the two~     techniques. This is also the first study to use standardized methods of assessing union~     (based on computerized tomography), standardized methods of collecting objective patient~     data, and utilizing validated patient questionnaires to assess pain and disability.~   "
124977|NCT01419795|"~     This phase II trial studies how well giving lenalidomide with or without rituximab works in~     treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small~     lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL).~     Biological therapies, such as lenalidomide, may stimulate the immune system in different~     ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block~     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them. Giving~     lenalidomide together with or without rituximab may kill more cancer cells.~   "
124978|NCT01419782|"~     The aim of this study is to investigate effects of femur exposed to unilateral vibration on~     the rest muscle electrical activity of contralateral hip adductors and contralateral soleus~     H-reflex in young adult men.~      This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle~     electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle~     strength and power. Previous studies have shown that vibration increases muscle~     electromyographic (EMG) activity. It has been showed that bone has an effect on the increase~     in muscle EMG activity caused by vibration in healthy young adults in a study. In this~     study, it was reported that vibrations-induced increases in muscle electrical activity of~     flexor carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and~     the FCR H-reflex was suppressed or depressed during vibration. This findings were reported~     to support the assumption that the bone exposed to cyclic mechanical loading may neuronally~     regulate muscle activity.~   "
124979|NCT01419769|"~     The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and~     this study is being conducted under an Investigational Device Exemption (IDE) granted by the~     US Food and Drug Administration (FDA).~      The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized)~     study. Up to 10 sites in the United States, European Community and/or Japan will enroll a~     total of 24 patients. A majority of the patients will be enrolled in the United States.~      Patients will be followed at (approximately) 30 days and/or 60 days depending upon~     pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6~     month post-stent removal.~   "
124980|NCT01419756|"~     Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with~     Tetralogy of Fallot following repair; a comparison study to cMRI.~      The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System~     to calculate right ventricular volumes in patients with Tetralogy of Fallot following~     surgical repair.~      Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical~     sites.~      The analyses will be the same for EDV and ESV. For either right ventricular volume, the~     primary effectiveness measure is the % difference between VMS and cMRI results, i.e.~     (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the~     primary analysis:~      H0+: true mean % difference > 10% and H0-: true mean % difference < -10%~      The observed mean % difference will be presented with 95% confidence intervals. The VMS~     right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both~     H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV.~     Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025~     and the overall type I error rate for both EDV and ESV is 0.05.~   "
124981|NCT01419743|"~     Historically, vitamin D has been considered to play a role solely in bone and calcium~     metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse~     health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose~     metabolism. In the obstetrics literature, vitamin D deficiency has been linked to~     preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data~     from retrospective chart reviews have demonstrated a possible role of vitamin D in~     implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization.~     Patients found to be deficient in vitamin D were found to have significantly lower clinical~     pregnancy rates when compared to patients who were replete in vitamin D levels. Currently,~     there are no prospective clinical trials investigating the effects of vitamin D~     supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The~     investigators hypothesize that the vitamin D supplementation in patients found to be either~     deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility~     patients undergoing in-vitro fertilization.~   "
124988|NCT01419652|"~     There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third~     of patients presenting for coronary angiography have known DM, and an additional 20% of~     patients without known DM present with hyperglycemia on the day of coronary angiography.~     Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI)~     is associated with a 40% relative increase in long-term mortality regardless of diabetic~     status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly~     understood and the effects of treatment are unknown. This is a pilot study aimed at~     determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic~     medications on the morning of coronary angiography. Since hyperglycemia may cause increased~     platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of~     periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic~     medications undergoing coronary angiography will be randomized to either continue or hold~     their clinically-prescribed long-acting hypoglycemic medications on the day of procedure.~     Patients with and without DM will be randomized to either routine care or additional~     glycemic control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary~     endpoint of this study will be mean blood glucose level at the time of arterial access in~     the hold versus continue groups. Secondary endpoints will be mean blood glucose level at 6~     hours post-PCI in the Yale versus routine care groups and number of hypoglycemic events in~     the glycemic control versus no glycemic control groups. The exploratory analysis assessing~     the effect of glycemic control on platelet activity will guide further studies evaluating~     the translation of an individual's platelet phenotype to the clinical risk of increased~     long-term mortality following PCI. The outcomes for this study (glucose levels and platelet~     function) are all measured during the hospital stay which averages 1 day.~   "
124989|NCT01419639|"~     This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.~   "
124990|NCT01419613|"~     The purpose of this study is to find out if a counseling program the investigators have~     developed can help breast cancer survivors adopt a healthier lifestyle.~   "
124991|NCT01419600|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of increasing single doses of AZD8683 administered via inhalation~   "
124992|NCT01419587|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by lung cancer patients.~   "
124993|NCT01419574|"~     Background:~      - Treatments for partly blocked carotid arteries are determined by a person s symptoms and~     by tests that show how severe the blockage is. Studies show that the material that blocks an~     artery is more important in spotting future problems than how tight the blockage is.~     Researchers want to develop better imaging studies to find which blockages are more~     high-risk.~      Objectives:~      - To use imaging studies to look at high-risk carotid artery blockages.~      Eligibility:~      - Individuals at least 21 years of age whose ultrasound exams show a major carotid artery~     blockage.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, , an ultrasound scan and a magnetic resonance imaging (MRI) scan.~        -  Participants will have ultrasound and other scans to obtain pictures of the arteries.~          The scans will use drugs that may help study doctors get a better picture of the blood~          vessels and blockages.~        -  Participants will have followup phone calls yearly for 3 years. If a participant later~          has surgery to remove the blockage, the surgeon will save part of it for future study.~   "
124994|NCT01419561|"~     Background:~      - KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi~     sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can~     have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen.~     People with KICS may also be at risk of getting other cancers associated with KSHV. These~     cancers include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease,~     more information is needed on how the disease works and what can be done to treat it.~      Objectives:~      - To collect genetic and medical information from people with KSHV inflammatory cytokine~     syndrome.~      Eligibility:~      - Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms~     that resemble those caused by KICS.~      Design:~        -  Participants will have regular study visits. The schedule will be determined by the~          study researchers.~        -  Participants will provide a complete medical history and have a full physical exam.~          Blood and urine samples will be collected as well.~        -  People with KICS that requires treatment may get new experimental treatments. These~          treatments may include antiviral drugs and chemotherapy drugs, depending on the nature~          of the disease.~        -  Participants will have imaging studies, such as chest x-rays and computed tomography~          scans, to study the tumors.~        -  Bone marrow and lymph node biopsies may be done to collect tissue samples for study.~        -  Participants who have Kaposi sarcoma will have photographs taken of their lesions.~   "
124995|NCT01419548|"~     Background:~      - Paclitaxel and carboplatin are two standard drugs that stop cancer cells from reproducing.~     ABT-888 is an experimental cancer drug that may prevent cancer cells from fixing the~     damage done by chemotherapy drugs. This may make the chemotherapy work better. More tests~     are needed to determine the safety and effectiveness of ABT-888 plus chemotherapy.~     Researchers also want to find the best dose of ABT-888 for people who have kidney or liver~     problems in addition to cancer.~      Objectives:~      - To test the safety and effectiveness of ABT-888 plus carboplatin and paclitaxel in people~     who have both cancer and kidney or liver problems.~      Eligibility:~        -  Individuals at least 18 years of age who have solid tumors that have not responded to~          standard treatment, and who also have kidney or liver problems.~        -  A small group of people with solid tumors and normal kidney and liver function may also~          receive treatment for study comparison purposes.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests, tumor samples, tests of liver and kidney function, and imaging~          studies. Participants will also provide a hair sample at the start of the study.~        -  Participants will take one dose of ABT-888 1 week before starting chemotherapy. The two~          chemotherapy drugs will be given on day 3 of a 21-day cycle. Participants will take~          ABT-888 daily for the first 7 days of each cycle.~        -  They will keep a diary to record medication doses and any side effects. They will also~          have frequent blood tests and imaging studies. Participants will provide more hair~          samples on day 3 of cycle 1 before and after having paclitaxel.~        -  Participants will continue treatment for up to 18 weeks as long as the cancer stops~          growing or shrinks and there are no serious side effects. Participants may have the~          option to continue treatment after the study is done.~   "
125008|NCT01419379|"~     This study is designed as a multicenter, prospective and retrospective and descriptive~     epidemiology study.~      This study is planned to evaluate 2 years of exacerbation in COPD patients and to~     investigate correlation of COPD disease progress and its exacerbation.~      This study is designed with 6 months of subject enrollments, 12 months of retrospective~     study, and 12 months of prospective study. Hence, each patient will be participating in the~     study for 12 months, while the actual data collections from the patients will take a total~     of 24 months.~      The statistical analysis of this study will be done twice, at the completion of 1 year~     retrospective data collection and at the completion of next 1 year follow-up.~      The 1st statistical analysis of retrospective study includes exacerbation rate, duration of~     hospitalization for exacerbation and lung function test for the past 1 year from the~     enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment~     will be analyzed.~      The 2nd statistical analysis of prospective 1-year follow-up includes changes in~     exacerbation rates, comparison of lung function test results, comorbidities, COPD~     assessments (CAT) and COPD medications of retrospective and prospective studies for the 2~     years as well as mortality rate.~   "
124996|NCT01419535|"~     Background:~        -  Metabolic syndrome is a name given to a group of factors that tend to occur together.~          These risk factors include central obesity (extra weight around the middle of the body)~          and high blood pressure and blood sugar levels. They also include low levels of HDL~          (good cholesterol) and high triglyceride levels. A person is said to have metabolic~          syndrome if they have three or more of the above risk factors. People with metabolic~          syndrome are at increased risk for type 2 diabetes, stroke, and heart disease.~        -  Cortisol, a hormone produced by the adrenal glands, is an important regulator of~          metabolism. People with central obesity and metabolic syndrome may have higher than~          normal cortisol levels that the body cannot regulate properly. Abnormal cortisol levels~          may play an important role in metabolic syndrome. Mifepristone is a drug that blocks~          cortisol. Researchers are interested in studying its effects on metabolic syndrome.~      Objectives:~      - To study the effects of short-term mifepristone treatment for metabolic syndrome.~      Eligibility:~      - Men and Women between 35 and 70 years of age are overweight or obese, and have abnormal~     glucose and triglyceride levels.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  Participants will be admitted to the metabolic unit at the National Institutes of~          Health Clinical Center for the first 3 days of the study:~        -  Day 1: Body measurements (height, weight, waist, hip, and neck) and blood pressure~          tests. Also, 24 hours of regular blood draws and 24-hour urine collection to monitor~          regular daily cortisol levels.~        -  Day 2: Glucose/insulin infusion test to measure blood sugar levels.~        -  Day 3: Infusion of cortisol-like compounds and then regular blood draws for about 3~          hours to evaluate how cortisol is metabolized.~        -  At the end of Day 3, participants will receive mifepristone or a look-alike capsule to~          take for 7 days at home.~        -  After 7 days, participants will return to the metabolic unit to repeat the Day 1 and~          Day 2 study procedures. They will continue to take mifepristone.~        -  One week after the second set of study tests, participants will return for a brief~          physical exam and blood tests.~        -  The study procedures will be repeated after 6 to 8 weeks, with the other study drug.~   "
124997|NCT01419522|"~     Background:~      - Many people who have had a traumatic brain injury have difficulty walking. Training on a~     treadmill is often used to help people with walking difficulties. Supporting a person s body~     weight with a harness while using the treadmill can help improve walking skills in people~     with brain injury. Varying the rate at which people walk on the treadmill may also help more~     than walking at a constant rate. Treadmill training with body weight support or walking at~     different speeds may improve walking skills in people who have had a traumatic brain injury.~     More research is needed to see if one method is better than the other.~      Objectives:~      - To compare the effects of two types of treadmill training in people who have had a~     traumatic brain injury.~      Eligibility:~      - People at least 18 years of age who have had a mild or moderate traumatic brain injury at~     least 6 months ago and have mild or moderate walking difficulty.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          take a basic walking test (not on a treadmill).~        -  Participants will be divided into two groups. The first group will have treadmill~          training at a constant speed. The second group will have treadmill training at~          different speeds. All participants will wear a support harness while walking on the~          treadmill.~        -  At the first training visit, participants will have a gait assessment with different~          tests of walking. Then they will have a treadmill walking session.~        -  After the first visit, participants will return twice a week for 6 weeks for treadmill~          training sessions (visits 3 through 12). They will also have grip strength and walking~          tests.~        -  At the end of 6 weeks, participants will have a final treadmill training session, and~          will have a gait assessment exactly like the one in the first training visit.~        -  At 6 months after the final session, participants will have a followup visit with a~          final gait assessment.~   "
124998|NCT01419509|"~     RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the~     disease has been disseminated.~      PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor,~     blood, and bone marrow samples from patients with rhabdomyosarcoma.~   "
124999|NCT01419496|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about cancer and development of drug resistance in patients.~      PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance~     in samples from patients with acute myeloid leukemia.~   "
125000|NCT01419483|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by patients.~   "
125001|NCT01419470|"~     safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044~     in premature ejaculation~   "
125002|NCT01419457|"~     This study is designed to determine the pharmacokinetics of favipiravir in volunteers with~     hepatic impairment and in healthy control volunteers.~   "
125003|NCT01419444|"~     The purpose of this research is to determine whether treatment of voice disorders can be~     provided just as effectively using telemedicine as it can using on-site, traditional~     therapy. An exercise protocol for improving airflow with voicing has been demonstrated to be~     effective in a prior UAMS investigation (Protocol 107454). These exercises are used as part~     of the normal clinic routine at UAMS working with individuals with voice problems. The three~     exercises used are: gargling with and without voicing; cup bubble blowing with and without~     voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to~     provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of~     the exercises is to increase airflow and breathiness in the voice and reduce muscle tension.~     In addition, patients will be taught to use a confidential voice or gentle voice during~     speaking.~      The investigators voice patients come from all over the state and many cannot return for~     regular treatment. Developing a way to provide treatment to them closer to home could~     greatly improve quality of care and quality of life. Twenty participants will participate~     for 12 sessions each. All participants will be evaluated at UAMS before and after treatment~     as part of standard care and will, upon consent, be randomized to receive treatment via~     telemedicine at an AHEC site or at UAMS Medical Center. Homework will be provided along with~     log sheets. Results of airflow measures using an airflow-recording device (Viasys,~     KAY/PENTAX) pre- and post treatment will determine whether telemedicine results are equal to~     results of traditional, on-site treatment. The investigators hypothesize that results from~     treatment using telemedicine will be equivalent to results for onsite, traditional~     treatment.~   "
125004|NCT01419431|"~     Pro-inflammatory responses following laparoscopic surgery.~   "
125005|NCT01419418|"~     Specific Aims: To delve into the complex phenomena of living with Peripheral Arterial~     Disease (PAD), and to investigate the patients' perspective of the factors that affects~     their decisions regarding management of their PAD.~      a) Utilize a qualitative approach to uncover factors that patients perceive support the~     management of their condition utilizing a purposive sampling of Peripheral Arterial Disease~     patients.~        1. To determine what they believe to be effective tools to support themselves to improve~          their condition.~        2. To determine from the patient's perspective if adherence to prescribed medical regimes~          are important for them to improve their PAD outcomes.~        3. To describe the patient factors of those who are self reported adherent compared to~          those who are not or unable to their prescribed regimen.~   "
125006|NCT01419405|"~     In this experimental study on healthy volunteers we explored the effect of pregabalin alone~     and in combination with remifentanil on acute experimental pain and ventilatory function.~   "
125007|NCT01419392|"~     The purpose of this study is to determine whether sildenafil citrate is effective in~     improving uterine artery blood flow and oxidative stress in patients with unexplained~     recurrent miscarriages~   "
125035|NCT01419028|"~     This study aims to characterize the natural history of patients with severe perinatal or~     infantile onset HPP.~   "
125009|NCT01419366|"~     Objective:~      To compare the rate and extent of release of the drug substance from the two tablet~     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and~     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period~     of at least 7 days.~      Study Design:~      Randomized, open label, two treatment, two period, two sequence, single dose, crossover~     study in healthy human adult subjects~   "
125010|NCT01419353|"~     The purpose of this study is to determine if pretreatment with Estrogen can assist in the~     planning and programming of In Vitro Fertilization treatments.~   "
125011|NCT01419340|"~     Objective:~      To compare the rate and extent of release of the drug substance from the two tablet~     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and~     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period~     of at least 7 days.~      Study Design:~      Randomized, open label, two treatment, two period, two sequence, single dose, crossover~     study in healthy human adult subjects~   "
125012|NCT01419327|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients in hemodialysis who received Fosrenol for~     hyperphosphatemia. The objective of this study is to assess safety and efficacy of using~     Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5~     years.~   "
125013|NCT01419314|"~     WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of~     splints at night works to bring the pain down and help you sleep better (in people living~     with HIV/AIDS related neuropathy).~      HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the~     Harris County Hospital District (HCHD).~      WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two~     treatment groups. In one group, you will be asked to wear leg splints at night and the other~     you will wear the liners of the splints only.~      You will be asked to answer questions about how well you sleep, how long you sleep, and~     about your discomfort at the legs. The researcher will be there to help, but the~     investigators want you to answer the questions on your own if you can. You will be asked to~     reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will~     de done in random order. The sessions will be done at the beginning, at week three and week~     six. You should finish all of the testing and questionnaires in an hour or less, for a total~     of three hours over six weeks in the investigators clinic.~      You will receive instructions on how to use the splints with liners or the liners alone at~     home. You will be asked to wear them at night only for the next 6 weeks. Finally, the~     principal investigator will contact you weekly by phone, to discuss issues of comfort and~     your ability to adhere to the instructions provided.~   "
125014|NCT01419301|"~     This study focuses on stress, cognition, mood and fatigue and its effect on medication~     compliance. Medication compliance is measured by the weight of discarded needles. The~     investigators will be administering neuropsychological testing at baseline and the final~     visit. The subjects will complete self-report assessments during their 8 weeks in the study.~      Group A will have additional weekly phone support for meditation, while Group B will have~     meditation training only.~   "
125015|NCT01419288|"~     Many people with a leg amputation have difficulty walking even after they have finished~     their rehabilitation. The purpose of this study is to see if a large amount of walking~     practice on a treadmill can improve functional abilities.~   "
125016|NCT01419275|"~     Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke~     patients~   "
125017|NCT01419262|"~     Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods.~     Vitamin D levels are alarmingly low in many North American children. Several health issues~     have been linked with low vitamin D. These include colds caused by viruses and asthma~     attacks. However, no study has determined whether vitamin D supplementation can reduce the~     risk of these conditions in young children where they are most common and most severe.~      The goals of this study are to determine whether wintertime high dose vitamin D~     supplementation of preschoolers can prevent colds and asthma attacks. The investigators also~     aim to work out how much money would be saved by the health care system and society if~     preschoolers were routinely supplemented with Vitamin D during the winter. The investigators~     believe that preschoolers receiving 'high dose' vitamin D supplementation during the~     wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and~     will be less likely to use the medical system and keep their parents away from work.~   "
125018|NCT01419249|"~     PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to~     confirm that some genes can be used to predict how well a subject diagnosed with idiopathic~     growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with~     recombinant human growth hormone (r-hGH).~   "
125019|NCT01419236|"~     The purpose of this study is to see if testosterone solution 2% can impact symptoms of~     ejaculatory dysfunction in men with low testosterone.~   "
125020|NCT01419223|"~     This is an exploratory qualitative interview study being conducted with a primary objective~     of examining perceptions held by active military and veterans regarding help-seeking~     attitudes and mental health beliefs which influence the decision to consent or decline~     participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI)~     clinical trials. Active duty military and/or veterans aged 18 years and older who consent to~     participate (N = 50), or have recently declined participation (N = 50), in an INTRuST~     affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited.~     Participants who consent to participate in an INTRuST clinical trial (Group 1) will be~     interviewed once at the beginning the of the clinical trial, and again following~     participation in the trial. Participants who decline participation in an INTRuST affiliated~     outpatient clinical trial (Group 2) will be interviewed once. For participants in both~     groups, study participation will initiate within 1 month of referral to study. Total~     duration of study participation is based on the specific clinical trial that the participant~     is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured~     qualitative individual interviews will be conducted to carry out a thematic analysis of the~     data exploring familial, social and institution-level constructs which may influence the~     subjective experience of the research treatment process.~   "
125021|NCT01419210|"~     The purpose of this study is to find out if complementary and alternative medicines (CAM)~     should be included with traditional therapy for women with ovarian cancer. Some of the~     alternative medicines include non-traditional drug and herbal therapies along with dietary~     and nutritional strategies. Only a few of these alternative medicines have been tested with~     women with ovarian cancer.~   "
125022|NCT01419197|"~     This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy~     and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's~     choice in participants with metastatic or unresectable locally advanced/recurrent human~     epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will~     be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days~     or treatment of the physician's choice. Participants continue to receive study treatment~     until disease progression or unacceptable toxicity occurs. This study is also known under~     Roche study protocol number BO25734.~   "
125023|NCT01419184|"~     This was a real-world, prospective, open-label, multicenter study in which participants were~     randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of~     this study is to compare infection-related hospital length of stay, along with a number of~     participant-reported outcomes, between participants with complicated skin and soft tissue~     infection treated with daptomycin and vancomycin.~   "
125024|NCT01419171|"~     The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary~     Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery~     lesion.~   "
125025|NCT01419158|"~     Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic~     obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD~     is not as rare as originally thought and undetected AATD may account for COPD in some~     patients. This study was designed to evaluate the frequency of undetected AATD in a~     population reporting to academic pulmonary function testing facilities who meet criteria for~     the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and~     offered free testing for AATD. The results will help identify the percent of those with COPD~     who have undetected AATD.~   "
125026|NCT01419145|"~     A multicentre, open, randomized phase II study comparing a multimodal intervention (oral~     nutritional supplements, celecoxib and physical exercise) for cachexia versus standard~     cancer care.~   "
125027|NCT01419132|"~     High values of cardiac troponin (Ct) in acute heart failure (ADHF) identify patients (pts)~     at higher risk and worsened prognosis. A Ct increase during therapy indicates the need for~     more appropriate intervention, aimed at compensating cardiac disease and effectively~     minimizing myocardial wall stress and subsequent cytolysis. This study evaluated the effects~     of an intravenous high-dose of furosemide with or without small-volume hypertonic saline~     solution (HSS)on myocardial cytolysis in ADHF pts.~   "
125028|NCT01419119|"~     The purpose of this study is to determine the efficacy of different doses of vitamin D in~     persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.~   "
125029|NCT01419106|"~     This study is designed to determine if there is any relationship between performing an~     abdominal ultrasound on patients who present with hypotension and their clinical outcomes~     (as measured by 7, 30 day and discharge mortality).~   "
125030|NCT01419093|"~     The project is a two-arm randomized clinical trial to pilot the feasibility of a~     communication training intervention for primary care clinicians, linked to a community~     program referral, on use of the 5As to promote physical activity in underserved patients.~   "
125031|NCT01419080|"~     An estimated 8 million individuals in America are affected by peripheral arterial disease~     (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD~     can have a tremendous impact on patients' quality of life. It is also associated with high~     rates of heart attacks and premature death. While there are a number of treatments, there~     have been few previous studies that have prospectively examined treatment patterns for PAD~     or sought to systematically identify opportunities to improve care. Most importantly, there~     have been no rigorous studies examining the impact of the disease from patients'~     perspectives - their symptoms, function and quality of life - as a function of different~     patient characteristics and treatments. The PORTRAIT study (Phase II) will systematically~     document the treatments and health status (symptom, function and quality of life) outcomes~     of 840 US patients over the course of one year (assessments at baseline, 3, 6, and 12~     months) from 10 centers to address these gaps in knowledge. It will illuminate whether~     disparities in treatment or health status outcomes exist as a function of patients' age,~     gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially~     elevate the field and identify critical gaps in the way PAD is currently managed, including~     potential disparities in care, so that the quality of care can be improved.~   "
125032|NCT01419067|"~     The goal of this study is to determine the feasibility and safety of treating patients with~     a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target~     volume margin in combination with proton therapy. Proton therapy will be indicated for~     patients with diagnosed craniopharyngioma who are not treated with radical surgery~     (gross-total resection). Irradiated patients will undergo a series of evaluations designed~     to evaluate the effects of proton therapy. Similar evaluations will be performed on patients~     treated with radical surgery. Proton therapy will include 30 treatment fractions~     administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst~     expansion and target volume deformation.~   "
125033|NCT01419054|"~     Healthcare associated infections increase morbidity and mortality among all hospitalized~     patients, especially in those who are immunocompromised, in both developed and in countries~     with limited resources. However, when resources are limited, infection prevention and~     control measures are often overlooked by personnel and institutions. Hand hygiene has been~     shown numerous times to be the most effective way to prevent infections in the healthcare~     setting. In Unidad Nacional de Oncologia Pediatrica (UNOP) in Guatemala City, Guatemala,~     there have been several infrastructural improvements and periodic education and promotion~     activities. Still, acceptable hand hygiene compliance has not yet been sustainably achieved.~     The investigators wish to study reasons why staff at UNOP do or do not practice hand hygiene~     when it is indicated through the use of focus groups and interviews.~   "
125034|NCT01419041|"~     The present study is being conducted to evaluate whether or not severe renal impairment has~     an effect on crizotinib Pharmacokinetics.~   "
125036|NCT01419015|"~     A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the~     20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral~     delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to~     evaluate the system performance as well as a post market clinical follow-up phase involving~     long term follow-up of all patients to evaluate the safety of investigational devices up to~     5 years.~   "
125037|NCT01419002|"~     Net-Pac investigates if radiation prior to surgical resection improves survival in patients~     with pancreatic head cancer without metastases.~   "
125038|NCT01418989|"~     This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra~     (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy~     volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra~     (tocilizumab). The anticipated time of study duration is 28 days.~   "
125039|NCT01418976|"~     This is a case series study evaluating the feasibility and dosage of Intensive Mobility~     Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury~     (TBI) causing significant locomotor impairment, who meet these specific criteria, will be~     recruited. Location and nature of neural insult will be determined by multimodal Magnetic~     Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per~     day for 20 days, focusing on gait and balance. Locomotion and balance will be~     comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full~     dose of IMT. This study will determine the feasibility of this intervention in the~     population of TBI patients, allow an estimate of effect size and provide initial information~     on possible neural predictors of success. Furthermore the investigators will be able to~     determine whether the dosage of 10 days is sufficient or whether significant improvements~     are made with 20 days of the intervention.~   "
125040|NCT01418963|"~     This two-part, randomized, double-blind, placebo-controlled study will assess the safety,~     pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of~     RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each~     subject.~   "
125041|NCT01418950|"~     Pregnant women who receive study counseling which includes gestational age specific written~     information in addition to the verbal counseling will have better knowledge of problems and~     outcomes of prematurity than women who receive standard counseling which consists of only~     verbal counseling.~   "
125042|NCT01418937|"~     This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV~     vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and~     received a placebo in the HPV-001 (NCT00689741) study.~   "
125043|NCT01418924|"~     The aim of this study is to determine whether plasma sclerostin levels is affected by sex~     hormones during menstrual cycle. Blood samples will be obtained at the beginning (between~     2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle.~     Serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by~     only one investigator~   "
125044|NCT01418911|"~     This study will expand the understanding of factors associated with adherence to self care~     and the diabetes control among diabetes type 2 patients. The theoretical framework of the~     study incorporates central variables from two theoretical models: a cognitive model of~     health behavior - Health Belief Model, and the Stress and Coping model. The study is~     innovative in its focus on the association between the patient's attachment style and~     adherence to self care and diabetes control, a topic less studied among diabetes patients,~     in addition to cognitive, social and emotional variables. Further emphasis is upon a~     comparison of the study model between males and females.~   "
125045|NCT01418898|"~     This study will follow a randomized, double-blind, placebo-controlled, parallel-group design~     to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve~     nutrient status and iron deficiency in young children compared to an unfortified control~     beverage.~   "
125046|NCT01418885|"~     SIVD is characterised by extensive cerebral white matter lesions (WML) and lacunar infarcts~     in deep grey and white matter structures. The relationship between SIVD and cognition is~     unclear, in part because of methodological inconsistencies across studies.~      Diffusion tensor imaging (DTI) is a non-invasive water diffusion technique and can be used~     for quantitatively measuring the degree and directionality of the displacement distribution~     of water molecules. 1H magnetic resonance spectroscopy (1H-MRS) is a valuable tool for the~     assessment of several biochemical compounds in the brain in vivo, such as N-acetylaspartate~     (NAA), myoinositol (mI), Choline (Cho) and Creatine (Cr). There were few reports considering~     the relationship among MRS, DTI and cognitive impairment of SIVD. Combining MRS with DTI may~     provide valuable information about the pathophysiological changes underlying DTI~     abnormalities and help us to better understand the SIVD process. It has been proposed that~     the pathogenesis of SIVD related to cerebral small vessel disease caused by various~     mechanisms. Inflammation plays an important role in the pathogenesis of SIVD. The~     examination of inflammatory markers in relation to VaD might be benefit to early treatment.~      In this study we applied neuropsychological tests, conventional MRI scanning, DTI, 1H-MRS~     techniques and inflammatory markers to estimate neuropsychological profile and white matter~     characteristics of imaging in patients with SIVD. Moreover, the relationship between WML and~     cognitive function impairment was also investigated. It could be possible to gain reliable~     data which is benefit to early diagnosis and treatment of cognitive impairment in SIVD.~   "
125047|NCT01418872|"~     AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º~     grade in the community of Madrid.~      DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY:~     Children of both sexes enrolled in 2º grade in public schools in the community of Madrid.~     Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an~     experimental group that the investigators organized a concert teaching focused on messages~     cardio, a second group or control group to which they will host a healthy breakfast as it~     has been offering the Community of Madrid .~      MEASUREMENTS: The primary end result is the increase of correct answers on a standardized~     test to be administered before and after the activity.~      Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall~     weight and center from before the intervention at 6 months of it.~   "
125049|NCT01418846|"~     The purpose of this study is to investigate the intra-saliva penetration of voriconazole in~     different subpopulations. The goal is to develop, optimize and validate an easy,~     non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can~     be used in children, ambulatory patients and in patients in whom blood drawing is difficult.~   "
125050|NCT01418833|"~     The first goal of this study is to map all the subtherapeutic, therapeutic and~     supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second~     objective is to optimize and validate guidelines for dose modifications in patients with too~     low or high plasma concentrations and to investigate if the same guidelines can be used in~     different patient populations.~   "
125051|NCT01418820|"~     Visual field areas, which are not absolutely blind, are hypothesized to have some residual~     capacities that constitute their potential for vision restoration. Vision restoration can be~     achieved by varies methods including behavioral training and electrical brain stimulation~     such as transcranial direct current stimulation (tDCS) and repetitive transorbital~     alternating current stimulation (rtACS) which are able to influence the excitability and~     activity of cortical areas.~      It is hypothesized that transorbital alternating current stimulation (tACS) can improve the~     residual field of vision in patients with post-chiasmatic lesions.~   "
125052|NCT01418807|"~     We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when~     transvaginal rather than transumbilical specimen extraction is accomplished. This would be~     due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of~     post-operative pain will be obtained and patients satisfaction will be asked at the 2-month~     postoperative visit.~   "
125053|NCT01418794|"~     Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis.~     Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent~     reduction in restenosis. This prospective, multicenter, randomized controlled clinical~     trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse~     coronary artery disease.~   "
125054|NCT01418781|"~     We will study whether the health care costs and health utilities differ in patients with~     gout and those without gout and whether they differ between those with more severe versus~     less severe gout~   "
125055|NCT01418768|"~     The purpose of this study is to determine if there is a change in the CAT-score after an~     inpatient rehabilitation of three weeks and if it correlates with other common parameters.~   "
125056|NCT01418755|"~     Recently an articular cartilage repair has been given much attention in the orthopaedic~     field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a~     delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains~     proliferative and chemoattractant growth factors. The objective of the present study was to~     determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.~   "
125057|NCT01418742|"~     Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and~     non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of~     fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.~   "
125058|NCT01418729|"~     The purpose of this study is to evaluate the overall survival (OS) in order to assess the~     efficacy and safety of pravastatin as adjuvant treatment to sorafenib.~   "
125059|NCT01418716|"~     The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to~     improve cardiovascular prevention in primary care. It addresses priorities in primary care~     relevant to the Chronic Care Model (Wagner 2001): self-management support, delivery-system~     design, and management of clinical information.~      The program includes :~        -  a case manager to coordinate and provide care and follow up;~        -  clinical protocols and tools to support interprofessional and systematic follow up;~        -  training for clinicians;~        -  patient's personalized cardiovascular health booklet;~        -  tools to promote group sessions for patient education on cholesterol, hypertension, and~          diabetes.~      The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for~     implementing the TRANSIT program in Family Medicine Groups (FMGs):~        1. facilitation, and~        2. passive diffusion.~      Passive diffusion is the usual strategy where clinicians implement an intervention program~     by themselves. Facilitation is a strategy whereby a facilitator provides support to a team~     of clinicians to help them introduce the changes required to implement the program into~     practice.~      The hypothesis is that facilitation will be more efficacious to implement the program than~     passive diffusion:~        -  it will enhance the provision of cardiovascular preventive care;~        -  it will enhance interprofessional collaboration;~        -  it will enable more efficaciously the implementation of new clinical processes;~        -  it will improve patient clinical outcomes;~        -  it will cost more in the short term, but will have positive economic impact in the long~          term;~        -  there will be less undesired effects of all types related to implementation.~      To test the hypothesis, we assess the efficacy of the implementation strategies to enhance~     interprofessional collaboration and better support patients in the management of their~     conditions. Impact on provision of care, interprofessional collaboration, clinical~     processes, and patient clinical outcomes (values, therapeutic targets, and lifestyle habits)~     will be evaluated. Moreover, the implementation cost related to each strategy will be~     estimated.~      We complement the trial with qualitative methods to document the perceptions of clinicians,~     facilitators, patients and members of the family regarding the TRANSIT program, the~     implementation strategies and the observed changes in the clinical practices and outcomes.~   "
125060|NCT01418703|"~     In this protocol the investigators plan to demonstrate the feasibility of a modular insulin~     management system based on continuous glucose monitoring and targeted towards the avoidance~     of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol~     is designed to challenge the insulin management system with meals and mild exercise, so as~     to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.~     This system is designed to both~        -  monitor the meal boluses of the patient and correct it in case of observed/predicted~          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and~          subjective knowledge of the meal amount, a precise understanding of the subject's day~          to day insulin treatment, continuous glucose monitoring, and past insulin injections;~        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past~          insulin injection.~      The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected~     retention 10/12) and compare glucose control performances under two treatments: standard vs.~     the new insulin management system. The protocol will include a total of 6 admissions per~     subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1,~     inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the~     patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage~     of these events will vary depending on the chosen treatment, each subject will be exposed to~     both studied treatments (repeated measure design).The order of treatment during the~     inpatient admissions will be randomized.~   "
125076|NCT01418495|"~     This research trial is studying how Ch14.18 acts in the body of younger patients with~     high-risk neuroblastoma. Studying samples of blood from patients with cancer receiving~     Ch14.18 may help doctors learn more about how this drug is used by the body to develop~     better ways to give the drug to potentially improve its effectiveness and lessen its side~     effects.~   "
125061|NCT01418690|"~     Adequate tissue oxygenation is required for effective white blood cell function and~     bactericidal activity. Decreased tissue oxygenation is a risk factor for perioperative wound~     infections. Regional anesthetic techniques result in a functional sympathetic block and may~     increase tissue oxygenation. The purpose of this study is to evaluate changes in tissue~     oxygenation using a non-invasive Near-infrared spectroscopy (NIRS) device. The current study~     will evaluate changes in tissue oxygenation following regional anesthetic techniques~     (peripheral nerve blockade and neuraxial techniques such as caudal block) in pediatric~     patients).~      Regional anesthesia will induce a sympathetic blockade and improve tissue oxygenation.~   "
125062|NCT01418677|"~     This is an open-label non-randomized study in subjects with advanced or metastatic solid~     tumors who are no longer responding to available therapy. HALAVEN will be administered to~     subjects on Days 1 and 8 of a 21-day cycle.~   "
125063|NCT01418664|"~     We hypothesized that vitamin D supplementation during pregnancy can prevent adverse~     pregnancy outcome.~   "
125064|NCT01418651|"~     Participants will undertake a 12-week, open-label study of milnacipran in a~     well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and~     older to investigate the short-term efficacy and safety of this drug in the elderly~     population. The investigators hypothesize that milnacipran will be effective in treating~     fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the~     absence of pre-existing blood pressure abnormalities and other serious medical conditions.~   "
125065|NCT01418638|"~     Objective There is growing evidence showing a relation between depression, metabolic~     syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight~     (4), as well as the effects of some of the antidepressant medications on these various~     conditions and profiles.~      The aim of the study is to examine the influence of antidepressant medications on the~     metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).~      Group of patients:~      30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.~      Research Design and Methods:~      Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited~     after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be~     taken at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.~      The following metabolic parameters will be examined at base-line and at the end of the 8~     weeks:~      Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in~     meters)2), sitting blood pressure (after 3 minutes of sitting).~      Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein~     cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol,~     Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).~      Fasting glucose and insulin blood levels, in order to evaluate insulin-release and~     resistance, according to the following formulas:~      Insulin Resistance:~      HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405~      Insulin Release:~      HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters~     according to the F2-Isoprostane kit will be measured.~      Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid~     reactive substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes~     will be measured at 234nm (14, 15).~   "
125066|NCT01418625|"~     Objective:~      The Bioequivalence studies were performed to compare the rate and extent of release of the~     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride~     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®~     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,~     USA.~      Study Design:~      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose~     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test~     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule~     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers~   "
125067|NCT01418612|"~     Objective:~      The Bioequivalence studies were performed to compare the rate and extent of release of the~     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride~     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®~     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,~     USA.~      Study Design:~      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose~     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test~     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule~     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers~   "
125068|NCT01418599|"~     Objective:~      Primary objective of the present study was to assess the relative bioavailability of two~     formulations of Extended Release Alfuzosin 10 mg under Fed conditions, in healthy adult male~     subjects after an oral administration with 7 days washout period.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
125069|NCT01418586|"~     Objective:~      Primary objective of the present study was to assess the relative bioavailability of two~     formulations of Extended Release Alfuzosin 10 mg under Fasted conditions, in healthy adult~     male subjects after an oral administration with 7 days washout period.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
125070|NCT01418573|"~     The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as~     compared to a meal constructed along the lines of the WHO dietary recommendations.~   "
125071|NCT01418560|"~     The purpose of this study is to observe the incident of uremia and dialysis requirement~     after renal sympathetic modification using THERMOCOOL® catheter in patients with chronic~     renal failure, and evaluate safety and efficacy of the intervention.~   "
125072|NCT01418547|"~     Objective:~      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER~     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban,~     USA under fed condition. Dosing periods were separated by a washout period of 8 days.~      Study Design:~      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects~   "
125073|NCT01418534|"~     Objective:~      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER~     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban,~     USA. Dosing periods were separated by a washout period of 8 days.~      Study Design:~      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects~   "
125074|NCT01418521|"~     The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to~     show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in~     terms of safety and effectiveness as the commonly used albumin based solution for volume~     replacement after the surgery.~   "
125077|NCT01418482|"~     The investigation is designed as an open, non-controlled, post-marketing investigation.~     Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will~     be included. The subject is allowed to have more than one burn on the body but only one~     should be included in the investigation. Each subject will be followed/assessed according to~     normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired~     treatment effect is obtained if that occurs earlier. All dressing changes will be done~     according to clinical routine and will follow the IFU (instruction for use). All dressing~     changes will be registered in a dressing log. Additional compression bandaging, gauze wrap,~     or such are allowed and should be reported as well~   "
125078|NCT01418469|"~     Studies on resting human muscle show that ingestion of the branched-chain amino acids~     (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism.~     However, the effects of BCAA intake on protein metabolism during exercise are less clear.~     When BCAA were supplied as single amino acids, without other amino acids and/or~     carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of~     BCAA during running appeared to reduce the catabolic effect of running on muscle protein~     metabolism. These experiments were all performed with mixtures of the BCAA with or without~     carbohydrates but not in the form of complete meals with food protein as a basis. Therefore,~     it is still unknown whether a protein meal, containing a substantial amount of BCAA is~     beneficial during exercise by inducing an anabolic effect.~      Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein.~     Therefore, it is hypothesized that milk-based proteins are a better and more physiological~     source of BCAA during exercise and will lead to more protein anabolism. Most of the~     available studies have been carried out in young and fit humans but there are hardly any~     data are available in the increasing population of the elderly. Therefore it is still~     unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in~     older individuals.~      Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic~     disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important~     health care problem. COPD is the fourth leading cause of death and will be the third leading~     cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease,~     associated with alterations in intermediary metabolism. Substantial disturbances have been~     found in BCAA (and related) metabolism in these patients at rest and during exercise. It~     might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein~     meals in patients with COPD at rest and during exercise.~   "
125079|NCT01418456|"~     The overall objective is to investigate whether antibiotics in the treatment of clinically~     clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence~     of infection and therefore lead to improved outcomes This is a single centre study in which~     patients with either type 1 or 2 diabetes mellitus, who consecutively present to the~     Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer~     without clinical signs of infection will be invited to take part and will express their~     willingness to take part in the study by signing a consent form.~        -  All patients will be treated and followed up in the DFC at King's College Hospital.~          Patients will be randomised into two groups: an antibiotic group and a control group.~        -  The antibiotic group will receive standard treatment along with antibiotics.~        -  The control group will have standard treatment alone.~        -  Patients from both groups will be reviewed at weekly intervals for a period of 20~          weeks.~        -  Patients will be removed from the study if they develop clinical signs of infection or~          if their ulcer heals prior to 20 weeks but will be followed up via routine practice for~          eventual outcomes~   "
125080|NCT01418443|"~     Objective:~      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed -~     Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 ×~     40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at~     least 7 days.~      Study Design:~      randomized, open label, two treatment, two period, two sequence, single dose, crossover~     study in healthy human adult subjects~   "
125081|NCT01418430|"~     The purpose of this study is to determine the safety of the combination of CHOP plus~     daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.~   "
125082|NCT01418417|"~     Objective:~      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed -~     Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 ×~     40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at~     least 7 days.~      Study Design:~      randomized, open label, two treatment, two period, two sequence, single dose, crossover~     study in healthy human adult subjects~   "
125083|NCT01418404|"~     In literature review, thermal stimulation (TS) intervention is effective in facilitating~     upper extremity functional recovery in stroke patients. In addition, several functional MRI~     studies have indicated that thermal stimuli promoted activation in the premotor and motor~     cortices of healthy participants. These imply the possibility of TS in cortical~     reorganization. However, there were no studies exploring the relationship of the TS~     intervention and cortical reorganization. By the functional recovery of stroke patients,~     findings of brain image and brain mapping, it could enhance the understanding the TS~     influences on brain reorganization. Regarding with clinical application of the TS~     intervention for improving functional performance of upper extremity in participants with~     stroke, the best parameters of TS intervention in clinical practice have not been decided.~     Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute,~     chronic) undergoing TS intervention with different parameters. Functional scales, kinematic~     data, brain image were taken in several timelines as outcome measures.~   "
125084|NCT01418391|"~     Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It~     had been reported the effect of post-operative pain control in minor abdominal surgery, such~     as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of~     the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus,~     the purpose of this study is to investigate the effect, such as analgesic effect,~     hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal~     laparotomy.~   "
125108|NCT01418079|"~     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the~     brain. It is similar to the device that measures the level of oxygen in the tip of the~     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the~     forehead that both emits and detects the amount of light absorbed. This study will determine~     how accurate the device is by comparing the displayed value on the monitor with blood~     samples taken simultaneously from the arterial blood in the wrist and venous blood in the~     neck. In order to test the device over a suitable range, the level of oxygen within the~     blood will be reduced in a controlled manner by reduction of the inspired oxygen~     concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study~     will be conducted in healthy volunteers.~   "
126055|NCT01405586|"~     The purpose of this study is to evaluate the addition of cisplatin to first-line~     chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms~     of overall survival.~   "
125085|NCT01418378|"~     This study will compare two very similar designs of knee replacement device. One device~     (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been~     modified to enhance/accommodate higher flexion. The original device has been in widespread~     clinical use with excellent results since 1996 and this study will determine whether the~     design modifications of the newer device add further value. The newer device has been in~     clinical use with good short-term(unpublished) outcomes since becoming commercially~     available in January 2009.~      Achieving higher knee flexion may be required for cultural reasons or by the increasingly~     younger, more active patient population undergoing knee replacement today. In addition to~     promoting flexion, it is also possible that this design change may help the knee replacement~     to last longer than traditional implants in patients who achieve higher flexion. Therefore,~     the study will compare the two devices in terms of survivorship, flexion and other measures~     of the success of a total knee replacement (range of motion, knee-related quality of life,~     activity and generic quality of life) over the short-term.~      A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and~     aged 50-75 years will be included at UK/international hospitals.~      Study duration is 2 years and patients will complete standard knee outcome scores plus~     radiological evaluation.~      Subjects would receive one of the study devices regardless of their involvement in the~     study, and apart from (possible)additional visits, x-rays and/or questionnaires, treatment~     and follow-up care will be as per the care they would receive outside of the study.~   "
125086|NCT01418365|"~     Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered~     alone & in combination with MMX® Mesalazine/mesalamine~   "
125087|NCT01418352|"~     The goal of the current trial is to determine efficacy and safety of Once-weekly~     aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's~     Disorder.~   "
125088|NCT01418339|"~     The goal of the current trial is to determine efficacy and safety of Once-weekly~     aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's~     Disorder.~   "
125089|NCT01418326|"~     Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?~      Aim: To retrospectively examine possible associations (Cox Multiple Regression) between~     survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during~     surgery, ahead of a prospective randomised controlled trial.~      Hypotheses: One- and five-year survival will be significantly higher after radical breast-,~     colorectal-, or skin cancer surgery in patients given the intravenously administered~     hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.~      Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical~     data from 6 303 patients operated on at the three mentioned anatomical locations at the~     Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these~     minimum 4 500 operations would be due to cancer. This register is unique, in that it~     contains both types of anaesthesia. The other register holds survival data (date and cause~     of death), stored at the Regional Oncologic Center in Uppsala.~      The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper~     file, concomitantly with extraction of details from anaesthesia and surgery, such as the~     functional classification of each patient (according to American Association of~     Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss~     and possible transfusion.~      Current knowledge: Different anaesthetics have opposite effects on the immune system and on~     the DNA. There is a well-established association between the state of the immune system and~     cancer growth, which in turn will influence survival. There is also an association between~     DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act~     pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory~     and anti-oxidative, and it is not genotoxic.~      Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in~     advance of a multi-centre, prospective, randomised, controlled trial.~      Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired~     effects from anaesthesia on survival has strong relevance for the over all cancer treatment.~   "
125090|NCT01418313|"~     The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI),~     dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for~     the detection and risk stratification of patients with atherosclerosis.~   "
125091|NCT01418300|"~     The purpose of this study is to improve first line Helicobacter pylori eradication rate and~     to compare the sequential versus conventional triple therapy.~   "
125092|NCT01418287|"~     A study to characterize children and adults with influenza like symptoms and to determine~     risk factors for severe disease and death among those with H1N1.~   "
125093|NCT01418274|"~     This single-arm, open-label, non-randomized study will evaluate the effect of~     danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in~     healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and~     escitalopram. The anticipated time of the study is 6 weeks.~   "
125094|NCT01418261|"~     The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,~     controlled study of the safety and effectiveness of renal denervation in subjects with~     uncontrolled hypertension. Bilateral renal denervation will be performed using the~     Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through~     the luminal surface of the renal artery.~   "
125095|NCT01418248|"~     Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can~     be diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise~     Testing (CPX) as compared with gold standard invasive hemodynamic assessment.~   "
125096|NCT01418235|"~     Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus~     (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV~     infections. The purpose of this study is to evaluate the safety and immunogenicity of 4~     experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.~   "
125097|NCT01418222|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line~     treatment in patients with metastatic colorectal cancer.~   "
125098|NCT01418209|"~     The primary objective of this study is to determine the efficacy of both low-dose oral (by~     mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in~     reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR~     to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is~     currently considered the most established but also a controversial therapy. 17-ß-estradiol~     is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine.~     Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a~     substance containing no medication.~   "
125109|NCT01418066|"~     In the present study the investigators are trying to evaluate the effect of Murraya koenigii~     leaves, Punica granatum and Curcuma which is administered to the patients in a combined form~     as tea. This study will help to evaluate the effect of these preparations scientifically in~     improving the IBS symptoms.~   "
125099|NCT01418196|"~     Metabolites of dietary phosphatidylcholine- choline and trimethylamine N-oxide (TMAO)- were~     recently identified as being associated with myocardial infarction in a case-control study.~     The latter TMAO is a gut-microflora-derived choline metabolite that has been shown to be a~     potent risk factor for cardiovascular disease (CVD). This pilot study seeks to use~     information derived from a dietary questionnaire in children to test the association of~     dietary choline intake to plasma levels of TMAO as well as the relationship between plasma~     choline levels and components of atherogenic dyslipidemia (increased triglycerides and small~     LDL, and reduced HDL cholesterol). An ancillary goal of this study is to build on existing~     programs of community outreach to local Oakland/Berkeley minority communities, and to~     develop an infrastructure for family-based and community participation in clinical research~     across the full age spectrum and among diverse populations. This pilot study will examine~     the association of dietary choline intake assessed by food frequency questionnaires to~     biomarkers of CVD risk in 40 children (> 7 years of age) and their parents as there is no~     information regarding this relationship in children. The results of this pilot study will~     form the basis for a proposal to carry out a randomized intervention trial to directly test~     the effects of dietary choline intake on plasma TMAO and lipoprotein levels. Ultimately,~     better understanding of the relationship between dietary choline intake and CVD risk factors~     may facilitate the formulation of appropriate dietary choline recommendations in children~     and adults.~   "
125100|NCT01418183|"~     This study will assess the efficacy and safety of levobupivacaine for postoperative pain~     control in patients received orthognathic surgery. In this split-mouth study, each side will~     be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3)~     placebo. One shot of these agents will be delivered by nerve block to maxillary and~     mandibular branches of trigeminal nerve before the incision was made. The degree of~     postoperative pain will be evaluated daily by visual analog scale for up to 3 days. The~     anticipated time on study is 1 year, and the target sample size is 40 individuals.~   "
125101|NCT01418170|"~     Specific Aim 1:~      To determine if the effect of cervical spinal manipulation on the pressure pain thresholds~     in a myofascial trigger point in the infraspinatus muscle can be enhanced and/or extended~     after a second cervical spine manipulation is given during a single subject visit.~      H1: There will be a statistically significant increase in pressure pain thresholds in the~     myofascial trigger point in the infraspinatus muscle after the second cervical spine~     manipulation, as compared to the first.~      Specific Aim 2:~      To determine if the effect of two cervical spinal manipulations on pressure pain thresholds~     in a myofascial trigger point in the infraspinatus muscle will be present at 48 hours~     follow-up. Data will be collected for descriptive purposes and hypothesis generation.~   "
125102|NCT01418157|"~     Acute mountain sickness is a common ailment in people venturing over 2500 m altitude.~     Pilgrims to high altitudes are at an added risk since they are unaware and they gain height~     faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of~     acute mountain sickness. There are no randomized controlled trials that have studied~     protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies~     regarding this matter.~      This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus~     placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent~     that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo~     will be randomly assigned for 3 days and participants will be assessed at 3 stations.~      This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be~     the first RCT done in this issue.~      The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent~     to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the~     incidence and severity of acute mountain sickness.~   "
125103|NCT01418144|"~     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane~     (TAP) block as a part of a multimodal postoperative pain management after laparoscopic~     surgery on colon.~   "
125104|NCT01418131|"~     Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations.~     Inflammation confined to the rectum occurs in a quarter of patients and can be extremely~     hard to treat. Many medications have been tried in order to control the inflammation, but~     they do not always work. One of the newer medications is the immunosuppressing medication,~     tacrolimus that has been shown to be effective in UC when taken orally. Unfortunately, the~     oral use of this medication can have numerous serious side effects. In order to overcome~     these side effects, the use of topical rectal tacrolimus has been examined. Pilot studies in~     ulcerative proctitis (inflammation confined to the rectum) resistant to conventional~     therapies have demonstrated a clinical remission in 75% of patients and although the~     medication was well absorbed through the lining of the bowel, the levels in the blood were~     very low and no serious side effects were reported. The findings suggest that this~     preparation is indeed effective for inflammation in the distal bowel and that the method of~     administration reduces side effects. Further work, however, now needs to be undertaken to~     validate the original findings.~   "
125105|NCT01418118|"~     Following surgery to remove tumours of the head and neck, patients undergo reconstruction~     with free flaps - tissue that is taken from elsewhere in the body and given a new blood~     supply by attaching it to vessels in the neck. Following this type of surgery, patients~     often need medication to maintain their blood pressure in the intensive care unit. The~     effect of these drugs on the transplanted tissues is unknown. This study investigates the~     effects of four commonly used drugs on free flap perfusion.~   "
125106|NCT01418105|"~     The research is about a prospective study conducted in patients suffering from dysphagia and~     cervical spine disorders and how they are interrelated. Three questionnaires have been given~     to patients with neurologic deficits, the first of these investigates the occurence of~     dysphagia in the three stages of swallowing, the second looks into the quality of life~     following a stroke or other neurologic damage and the third analyses how cervical spine~     disorders can affect every day life. After the bedside examination, VFSS or FEES, the~     patients are submitted to swallowing and cervical resistance exercises in fixed time periods~     after their hospitalisation. The results will be collected and evaluated using the~     statistical programme SPSS.~   "
125107|NCT01418092|"~     The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when~     administered daily to adults with OIC.~   "
125112|NCT01418027|"~     The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase~     of physical activity are recommended as an effective approach for the prevention and~     treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In~     the present study we aim to compare the effect of intensive and conventional exercise~     interventions on NAFLD.~   "
125113|NCT01418014|"~     The advances in treatment to prevent maternal HIV transmission to neonates have been~     groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is~     now small. Subsequent improvements in the treatment of HIV-infected infants and children~     have been equally remarkable, ensuring that most previously infected American children have~     survived and are approaching adolescence. In addition, the number of HIV-infected~     adolescents worldwide is growing substantially in both resource-poor countries and in~     countries with increasing levels of health care. Therefore, there is a global cohort of~     children who have been living with HIV infection since birth who are aging into adolescence.~     Little is definitively known about the impact of HIV infection and its treatment on the~     maturation process in these children.~      AMP is a prospective cohort study designed to define the impact of HIV infection and~     antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection.~     Domains to be investigated include growth and sexual maturation, metabolic risk factors for~     cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment,~     language, hearing and behavioral function, and sexually transmitted infections (STI).~   "
125114|NCT01418001|"~     The purpose of this study is to see the effects, good and/or bad, of the drug combination of~     gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial.~     The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is~     safe. The investigators determine this by closely checking for side effects that the patient~     may experience.~   "
125115|NCT01417988|"~     This study investigates the prevention of early mortality in patients initiating~     antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB~     reside. Many published studies have shown a surprisingly high proportion of all patients~     initiated on ART dying within 6 months (8-26%) with increasing risk with decreasing CD4 T~     cell count. The majority (median 70%) occur in the first 3 months with the greatest~     proportion of deaths due to previously undiagnosed tuberculosis (TB). The investigators will~     enroll patients from 4 geographically diverse countries (Gabon, Mozambique, South Africa,~     and Uganda) in a randomized open label clinical trial targeting a population of people with~     high mortality risk; patients with CD4 T cell count < 50 cells/μl and body mass index (BMI)~     < 18 kg/m2. Severely immunocompromised patients with low BMI in the intervention arm will~     receive presumptive anti-TB 4-drug chemotherapy and subsequently initiate ART within 2 weeks~     compared to ART alone. The main objective is to measure and compare early mortality in the~     group presumptively treated for TB in addition to ART. Other sub-objectives are to determine~     the predictors of early mortality and the causes of death by autopsy (traditional and~     verbal), to determine if presumptive anti-TB treatment affects viral suppression with ART,~     and to assess incidence rates and characterize drug toxicity in patients dually treated.~     Because of the high rates of TB co-infection in sub-Saharan Africa in the HIV-infected, the~     investigators expect that patients presumptively treated for TB in addition to HIV will have~     a lower mortality rate than patients receiving ART only. This trial is expected to be of~     great public health benefit and generalisability.~   "
125116|NCT01417975|"~     Female and male smokers will complete questionnaires and smoking behavior will be examined.~     After abstaining from smoking for approximately 18 hours, they will be randomized to a~     moderate intensity exercise groups or passive sitting group. Smoking satisfaction and~     smoking behavior will be assessed following treatment.~      The hypotheses detailed below are specific to the randomization of participants into the~     following 2 groups:~        1. Moderate exercise (Experimental condition; MEG)~        2. Passive sitting (Attention control condition; PSG)~      Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased~     smoking satisfaction after a temporary period of abstinence compared to a control condition.~      Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of~     moderate intensity exercise and smoking satisfaction.~   "
125117|NCT01417962|"~     The aim of this project is to establish whether magnetic resonance (MR) imaging can provide~     a minimally invasive approach for post-mortem assessment of the fetus, infant and child,~     with similar detection rates for anomalies and determination of the cause of death.~      This will be achieved by acquiring a database of whole-body, post-mortem MR images in~     approximately 400 fetuses, infants and children, over a 3 years period. Images will be~     acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert~     group of paediatric radiologists, and compared, in a blinded fashion, with reports from~     conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly,~     the post-mortem information will be assessed with reference to the needs of the parents,~     referring clinicians and HM Coroners. The detection of central nervous system abnormalities~     will be assessed separately.~      The study will be performed across two sites: A dedicated children's hospital (Great Ormond~     Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal~     departments (University College London Hospital), which are linked academically by~     University College London.~      Co-ordination of the project will be managed by a steering committee, which will ensure~     accurate collation and comparison of the data.~   "
125118|NCT01417949|"~     The purpose of this study is to compare the early versus deferred initiation of~     antiretroviral combination therapy consisting of tenofovir, emtricitabine and~     atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining~     illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).~   "
125119|NCT01417936|"~     The trial is designed as a multi-center, open label Phase 2 trial that investigates the~     efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck~     (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor~     receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to~     that therapy. It is believed that Sym004 has the potential to induce tumor responses and~     provide a superior treatment option to subjects with advanced SCCHN.~      Symphogen was the sponsor for planning/conducting and reporting results for this trial.~   "
125120|NCT01417923|"~     Vitamin D3 is produced in the skin following exposure to UVB light from the sun or~     artificial sources, and occurs naturally in a small range of foods.More recently, several~     reports underlined the impact of vitamin D on the prevalence and consequences of inadequate~     vitamin D intake and the research supporting its benefits for alleviating chronic~     musculoskeletal pain and fatigue syndromes in outpatients. Experts have recommended that~     vitamin D inadequacy should be addressed in all patients with bone or joint pain, myalgia,~     fibromyalgia, or chronic fatigue syndrome. It appears that soothing the daily~     musculoskeletal pain by supplementation of vitamin D may be a simple, well tolerated, and~     cost-effective modality.~      Aim of study:~      To study the potential therapeutic effects of vitamin D supplementation on patients with~     persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill~     Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36~     Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF~     and prostaglandin E will be assessed.~   "
125121|NCT01417910|"~     Over 3000 people each year undergo bypass operations to their lower limbs, and these~     operations carry significant risks with approximately 1 in 20 of these people dying in~     hospital, and another 1 in 20 having a heart attack.~      Assessment of these patients in order to stratify their risk of both dying and having~     significant complications aid in improving their care, enable better utilisation of scarce~     critical care resources, and allow us to give patients better information on which to base~     consent.~      Aims The aims of the project are to assess the feasibility of exercise testing this group of~     patients both with cycle and arm exercise, and to identify markers of outcome in this group.~      Methodology This is a prospective observational study designed to test the hypothesis that a~     combination of cardiopulmonary exercise testing and blood tests provides prognostic value on~     outcome measures after surgery for lower limb revascularisation~      Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their~     preoperative assessment appointment. From these tests we will measure how much work patients~     can do, how much oxygen they are able to use, and when the heart is unable to deliver enough~     oxygen to the cells. In addition they will have blood samples taken prior to the operation~     (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at~     cardiac markers of damage.~      This data will be used to see if we can predict those patients that have both short and long~     term complications, and also to see whether the different forms of exercise testing are~     comparable, or if one type is superior.~      Expected outcomes We expect that through a combination of exercise testing and blood test we~     will be able to identify patients at increased risk of complications after surgery. We also~     expect to find that arm exercise will be a more feasible and informative test that cycle~     exercise.~   "
125122|NCT01417897|"~     The planned HERMES study is to investigate and compare the effects of Insulin Glulisine,~     Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and~     several clinical and laboratory markers of postprandial endothelial cell function,~     sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary~     parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a~     biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are~     missing, it is not possible to calculate sample size and statistical power. Therefore the~     goal of the HERMES-Pilot-Study is to generate preliminary data for statistical~     considerations and estimations on the probability of success of HERMES.~   "
125123|NCT01417884|"~     Molecular targets on platelets are pivotal for the development of new pharmacological~     substrates for platelet inhibition and to better understand the impact of platelet-mediated~     inflammatory processes for the progression of heart disease, such as coronary heart disease~     and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have~     underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic~     efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19~     encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant~     drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation~     according to standardized protocols is necessary to enable the examination of the clinical~     relevance of potential molecular targets. A supplementary provision of high quality~     bio-material enables the systematic examination of new promising platelet-biomarkers in~     cardiovascular disease, which already have produced significant results on experimental~     animal and/or cell biologic models. Primary objective of the central project is to establish~     a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit~     (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential~     targets deriving from individual subprojects within the research group (German Research~     Council KFO 274/1-1) to safeguard a translational approach.~   "
125124|NCT01417871|"~     Aims: We evaluate the efficacy of the Active Body Control (ABC) Program for weight~     reduction in patients with metabolic syndrome.~      Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie~     diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized,~     clinical trial 60 patients will be treated according to the ABC program and 60 control~     patients will receive standard therapy.~   "
125125|NCT01417858|"~     The purpose of this study is to compare the intra-ocular (IOP) control efficacy between~     brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).~   "
125126|NCT01417845|"~     The purpose of this randomized clinical trial is to compare the effect of moderate versus~     high intensity exercise training on physical fitness and physical function in patients with~     type 2 diabetes. The research hypothesis is that high intensity exercise training will be~     superior to moderate intensity on such outcomes in individuals with type 2 diabetes.~   "
125127|NCT01417832|"~     The purpose of this study was to compare with a clinical randomized controlled split-mouth~     design study the changes in the therapeutic effect of infiltrating versus sealing proximal~     caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion~     progression, evaluated by radiographic techniques.~   "
125128|NCT01417819|"~     Rigorous and regular follow-up is essential to successful management of childhood cataract,~     but it is often ignored by parents and especially difficult to be delivered in China, such~     an average-medical-resource-limited country.~      Health programmes that use mobile communication technologies are emerging with the aim of~     strengthening health systems.~      The investigators aimed to assess whether mobile phone short message service (SMS) for~     parents of cataract children involved in the Childhood Cataract Program of Ministry of~     Health of China (CCPMOH) improved follow-up adherence and detection rate of the timing of~     surgery, postoperative complications and necessary replacement of glasses.~   "
125129|NCT01417806|"~     The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type~     1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these~     SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF~     which is known to contribute to SCLC proliferation. Topotecan is approved for second line~     therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents~     should yield greater antitumor activity.~   "
125130|NCT01417793|"~     According to WHO database, an average of 540 million people worldwide dies from smoking~     related diseases every year. The use of tobacco products may reduce the average life~     expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health~     showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking~     rate within prison inmates were between 64-91.8%, which was over 3 times than the general~     population. Smoking cessation can lower the risks of smoking related health problems. Two~     thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5%~     every year.~      In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry~     of Justice announced a smoking cessation program for inmates in April 2010. The purpose of~     this study was to investigate the effects of this program and the difference of cessation~     success rate between various interventional methods, using questionnaires for smokers and~     smoking cessation clinics database.~   "
125131|NCT01417780|"~     A study to evaluate the safety and pharmacokinetics profile of different doses of AB103~     administered to patients diagnosed with Necrotizing Soft Tissue Infections that are~     scheduled for an urgent surgical intervention as part of their standard of care.~   "
125132|NCT01417767|"~     The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine,~     homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk~     myelodysplastic syndromes(MDS).~   "
125133|NCT01417754|"~     To investigate if there are detectable changes in volume and circulation in breasts of~     healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus~     nonmedicated cycle.~   "
125134|NCT01417741|"~     The purpose of this study is to investigate the effects of intraoperative P6 acupuncture~     plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing~     tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to~     either the treatment or the control group.~        1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the~          induction of anesthesia~        2. Control Group: Standard anti-emetic therapy only~      This study will monitor nausea, retching, and vomiting events both directly after the~     surgery as well as the next day via a follow-up phone call to the parents of the study~     participant.~   "
125135|NCT01417728|"~     The aim of the study is to analyze the mechanism of action of infliximab at the~     endomicroscopic level and to analyze mucosal healing - i.e. structural and functional~     changes in the mucosa in IBD patients - and associated processes such as permeability and~     bacterial invasion of the mucosa. In this study the role of the above mentioned parameters~     and further the establishment of endomicroscopic scores will serve to define new prognostic~     markers in view of long term remission upon infliximab treatment.~   "
125136|NCT01417715|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal~     disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several~     macroscopic and histologic features including patterns of inflammation, crypt abscesses and~     granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for~     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy~     of the gastrointestinal mucosa during the endoscopic procedure.~      The main objective of this study is to determine endomicroscopic features of mucosal healing~     in patients with IBD.~   "
125137|NCT01417702|"~     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal~     disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several~     macroscopic and histologic features including patterns of inflammation, crypt abscesses and~     granulomas. i-Scan use an endoscopic image from the video processor and reconstruct virtual~     images in real time, resulting in an improved contrast of the capillary patterns and~     enhancement of the mucosal surface (so called virtual chromoendoscopy).~      The main objective of this study is to determine endoscopic features of mucosal healing in~     patients with IBD and to compare these features to clinical and histological data in order~     to establish a new endoscopic classification of mucosal healing and to evaluate mucosal~     healing as a parameter of remission and relapse.~   "
125138|NCT01417689|"~     Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of~     glaucoma patients have problems instilling their eyedrops. These problems include not~     hitting the eye, spending many drops to get a single successful instillation and bottle~     contamination.~      The present study will evaluate the effect of encouraging patients to put their eyedrops~     using one of 2 techniques, randomly assigned, to determine which is more successful at~     instilling the eye drop into the eye while spending the least amount of drug.~      In one of the techniques the patient instills the eye drop with their eyes open in the~     inferior cul de sac. In the other technique the patient instills the eye drop with the eyes~     closed near the inner canthal region.~      Patients will be randomized to encouragement to use the drops with either of the techniques.~     Encouragement will take place over a visit where they will be subjected to:~        -  Baseline evaluation of eye drop instillation using their usual technique.~        -  Short (2-5 minute) educational session session for the assigned technique.~        -  Followup evaluation immediately after the educational session.~   "
125139|NCT01417676|"~     This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety~     study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node~     radiation with simultaneous integrated boost to prostate in high risk prostate cancer~     patients.~   "
125140|NCT01417663|"~     Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular~     disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and~     the stiffening of the myocardium and arteries. New medication has been developed to break~     these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular~     physical activity is well known for cardiovascular disease and aging. Therefore, what is the~     most effective intervention, physical exercise and/or new medication AGE-crosslink breakers,~     in improving the cardiovascular and cerebrovascular compliance and improving the endothelial~     function in healthy sedentary elderly.~   "
125189|NCT01417065|"~     The goal of this clinical research trial is to study the effects of the FDA-approved drug,~     temsirolimus, using a new type of clinical study design called a Phase 0. This type of~     study may be able to predict if a drug can affect cancer and may be able to prevent~     potentially useful study drugs from being discarded before they are fully tested.~      The purpose of the study is not to treat the cancer, but to help improve general cancer~     treatment knowledge.~   "
125141|NCT01417650|"~     Temporomandibular disorder (TMD) is the major cause of nondental pain in orofacial area.~     Laser therapy can be considered as one of the most popular methods of pain relief in TMD~     patients. The special features of laser light such as coherence, monochromaticity, and~     collimation can result in the ability of laser light to modify cellular metabolism, increase~     tissue repair and reduce edema and inflammation. The effectiveness of low level laser~     therapy in reducing the signs and symptoms of temporomandibular joint disorders has been~     investigated in a few studies. But, in most of the previous studies the etiology of TMD has~     not been considered in patient selection. Furthermore, there are some controversies in the~     results of these studies. According to our data, there is no study evaluating the effects of~     low level laser therapy on patients having TMJ osteoarthritis.~      The aim of this study is to evaluate the effectiveness of low level laser therapy in~     improving osteoarthritis of temporomandibular joint and also to evaluate the long term~     effects of laser therapy on the morphology of the joint.~   "
125142|NCT01417637|"~     Temporomandibular disorders (TMDs) are the major cause of non-dental pain in orofacial area.~     Laser therapy can be considered as one of the most recent treatment approaches in the field~     of physiotherapy. The special features of laser light such as coherence, monochromaticity,~     and collimation can result in the ability of laser light to modify cellular metabolism,~     increase tissue repair and reduce edema and inflammation. Several studies demonstrated~     successful results regarding the use of low level lasers in releasing pain of~     musculoskeletal conditions, but there are also contradictory reports in this field, and the~     clinical effectiveness of this treatment modality has been debated in some review articles.~     A few studies evaluated the efficacy of low level laser therapy in the treatment of~     temporomandibular disorders and the associated myofacial pain. There are remarkable~     variations in the methodology of these researches and some reported insufficient data~     regarding the physical properties of the laser used. The aim of this study is to evaluate~     the effectiveness of low level laser therapy in improving the sign and symptoms of patients~     suffering from myofacial pain syndrome.~   "
125143|NCT01417624|"~     Heart failure is a common, costly, disabling and potentially lethal condition. Despite well~     recognised and proven drug therapies, many patients remain breathless on exertion. A special~     pacemaker (cardiac resynchronisation therapy) may help improve symptoms of breathlessness~     and survival by restoring coordinated beating of the heart. However, despite careful~     planning and the knowledge of the most appropriate selection criteria, up to a third of~     patients do not get the desired beneficial effects after the pacemaker has been implanted.~      The implantation of the special pacemaker requires three leads (wires) to be inserted within~     the heart. Currently this is undertaken under X-ray guidance. Some patients may have~     scarring of the heart muscle due to previous heart attacks or their underlying condition.~     The X-ray technique cannot see this and therefore the doctor may implant the lead in such an~     area of scar tissue. Cardiac magnetic resonance imaging (CMR) can demonstrate these areas of~     scar. The study aims to investigate whether CMR can better predict where the wires should be~     placed. The CMR pictures will be taken before the patient has the special pacemaker~     implanted.~   "
125144|NCT01417611|"~     Image-enhanced endoscopy in screening colonoscopy~        1. useful tool for detecting subtle epithelial lesions~        2. useful tool for predicting real-time histology of epithelial lesions. Among~          image-enhancing techniques, i-SCAN is new developed and the practical usefulness of~          i-scan for screening colonoscopy has not been investigated yet.~   "
125145|NCT01417598|"~     Balance control, physical activity and health related quality of life will be assessed~     before and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in~     200 elderly (>60) with balance problems (100 with osteoporosis, 100 with Parkinson's~     disease). Osteoporosis subjects will be assigned to 3 groups (balance training, balance~     training and Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance~     training or a control group). The training will be progressive and specific incorporating~     dual task exercises (directly related to an increased risk of falling). Clinical and~     laboratory gait and balance measures as well as questionnaires will be used to assess~     physical function and quality of life. An earlier study, investigating this training program~     in healthy elderly with balance problems showed that the training was well-tolerated and~     effective, with a significant increase in balance control, physical function and activity.~     In this study, we expect that an improvement in balance function, physical activity and~     health related quality of life, which will lead to a decreased number of falls, prevent~     and/or postpone incidence of a hazardous fall and thereby reduce the burden on the health~     care system. Our model for functional balance training and outcome methods will expand~     techniques and tools available to physical therapists and health care scientist treating and~     evaluating patients with loss of balance function. Elderly receiving therapy with the goal~     to improve or recuperate physical function and balance will benefit from this project.~   "
125146|NCT01417585|"~     This is a cluster randomized controlled trial in which client-centered rehabilitation of~     activities of daily living (CADL) will be compared to usual rehabilitation of activities of~     daily living (UADL) regarding participation in activities of daily living, independence in~     activities of daily living and life satisfaction during the first year after stroke. In~     addition use of health services, caregiver burden and significant others' life satisfaction~     will be studied. Study design, methods and power analysis are based on our previous pilot~     study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and~     Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3~     months after stroke, dependent in at least two activities of daily living, understand~     instructions and referred to a participating rehabilitation unit. Data are collected at~     baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In~     addition qualitative longitudinal studies will be performed in order to describe how CADL is~     integrated.~   "
125147|NCT01417572|"~     The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling~     surgery.~   "
125190|NCT01417052|"~     The primary objective of this study is to determine the safety of LX3305 in a dose~     escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis~     (RA).~   "
125191|NCT01417026|"~     The main objective of this study is to determine the safety and therapeutic potential of~     intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when~     paired with a computer game intervention that is designed to enhance face perception skills.~   "
125148|NCT01417546|"~     Background:~      - The experimental drug NHS-IL12 may help the immune system become more active and kill~     cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to~     cause less severe side effects than other anticancer drugs, and may be more effective. More~     research is needed to test NHS-IL12 in people who have solid tumors that have not responded~     to treatment.~      Objectives:~      - To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which~     have not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age with solid tumors that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history, physical exam, blood and urine~          tests, and imaging studies.~        -  Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the~          hospital for at least one day to be monitored with frequent blood tests.~        -  Participants will have periodic blood samples taken before treatment and during the~          first week after treatment for the first two cycles. They will then have blood samples~          taken before treatment for the rest of the cycles....~   "
125149|NCT01417533|"~     Background:~      - Hereditary inclusion body myopathy (HIBM) is a disease that causes walking difficulties~     and increasing muscle weakness. It usually develops in young adults (between 20 and 30 years~     of age), and affects arm and leg muscles. HIBM is caused by mutations in a gene that may~     affect how the muscles function. Researchers want to learn more about the causes, symptoms,~     and effects of HIBM.~      Objectives:~      - To collect genetic and medical information from people with hereditary inclusion body~     myopathy.~      Eligibility:~      - Individuals between 18 and 80 years of age who have hereditary inclusion body myopathy and~     do not use a wheelchair. - Participants must be willing to stop any current treatment of~     HIBM while enrolled in the study.~      Design:~        -  Participants will be screened with a medical history, physical exam, and neurological~          exam.~        -  At the first visit, participants will have the following tests:~        -  Questionnaires about the impact of HIBM on daily activities, mood, and quality of life~        -  24-hour urine collection~        -  Blood samples~        -  Heart function tests~        -  Muscle strength and endurance tests, including walking~        -  Imaging study of the muscles~        -  Participants will return for followup visits at 6, 12, and 18 months. They may be asked~          to return for a final visit at 24 months. Not all tests will be performed at each~          visit.~        -  Treatment will not be provided as part of this protocol.~      For more information, visit our website: http://hibmstudy.nhgri.nih.gov/~   "
125150|NCT01417520|"~     Background:~      - Erdheim Chester Disease (ECD) is a very rare disease in which abnormal white blood cells~     start growing and affect the bones, kidneys, skin, and brain. ECD can cause severe lung~     disease, kidney failure, heart disease, and other complications that lead to death. Because~     ECD is a rare disease, found mostly in men over 40 years of age, there is no standard~     treatment for it. More information is needed to find out what genes can cause ECD and how~     best to treat it.~      Objectives:~      - To collect study samples and medical information on people with Erdheim Chester Disease.~      Eligibility:~      - Individuals 2 to 80 year of age who have been diagnosed with Erdheim Chester Disease.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a study visit to provide samples for study, including blood,~          urine, and skin tissue samples. Participants will also have lung, heart, and muscle~          function tests; imaging studies of the brain, chest, and whole body; a treadmill~          running stress test; an eye exam; and other tests as needed by the study doctors.~        -  Participants will be asked to return for a similar set of tests every 2 years, and to~          remain in contact for possible treatment options.~   "
125151|NCT01417507|"~     This trial studies the natural history of brain function, quality of life, and seizure~     control in patients with brain tumor who have undergone surgery. Learning about brain~     function, quality of life, and seizure control in patients with brain tumor who have~     undergone surgery may help doctors learn more about the disease and find better methods of~     treatment and on-going care.~   "
125152|NCT01417494|"~     RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan~     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such~     as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving bevacizumab together with combination chemotherapy may be a~     better way to block tumor growth. It is not yet known whether combination chemotherapy is~     more effective when given together with or without bevacizumab in treating patients with~     colorectal cancer.~      PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab~     together with first-line chemotherapy and to see how well it works in treating older~     patients with metastatic colorectal cancer.~   "
125153|NCT01417481|"~     The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5~     g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic~     fibrosis, as compared with placebo. During all of the study children will receive their~     usual treatment for cystic fibrosis.~   "
125154|NCT01417468|"~     The purpose of this study is to determine whether learning styles are effective in the~     treatment of traumatic brain injury (TBI) in an educational environment.~   "
125155|NCT01417455|"~     Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are characterized by chronic~     systemic inflammation and share common pathogenic pathways. In both diseases, cytokines like~     TNF (tumor necrosis factor) and interleukin (IL)-17, known for their pro-inflammatory and~     osteoclastogenic effects, are relevant players, however, while RA is characterized by bone~     erosions, AS favors bone overgrowth. Understanding this paradox may hold the key for a~     better management of both diseases. Our hypothesis is that there are differences in the~     cellular environment and intracellular signaling between AS and RA. To test this hypothesis~     we will evaluate the cytokine milieu, the kinetics of bone cells differentiation and their~     activity in untreated and immunosuppressed RA and AS patients. We will also perform the same~     observations in patients exposed to targeted treatments.~   "
125156|NCT01417442|"~     The purpose of this study is to determine whether BRAF V600E mutation in our patients with~     papillary thyroid cancer has an association with poor prognosis.~   "
125192|NCT01417013|"~     The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to~     moderate dry eye subjects.~   "
125157|NCT01417429|"~     This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female~     smokers will first have two 4-day treatment periods, in which they will be randomized to~     galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14~     day washout period. During the first 3-days of each treatment period, smokers will have~     daily clinic visits, where they will receive study medications and any adverse effects from~     study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period,~     subjects will refrain from smoking for approximately 2.5 days, until the experimental~     session on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During~     the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine~     intravenously in a random, double-blind manner. The sequence of nicotine treatments will be~     counterbalanced among subjects such that equal number of subjects will receive saline first~     or nicotine first. Following each saline and nicotine treatments, physiological, subjective~     and cognitive measurements will be obtained~   "
125158|NCT01416415|"~     The purpose of this study is to assess whether an educational intervention will have a~     positive effect on patients' ability to properly administer eye drops. The investigators~     predict that the educational intervention will have a positive impact on the efficacy,~     safety, and efficiency with which patients administer their eye drops.~   "
125159|NCT01416402|"~     The purpose of this study is to determine whether arhalofenate is safe and effective when~     dosed in combination with febuxostat in lowering serum uric acid in patients with gout.~   "
125160|NCT01416389|"~     The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to~     ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change~     in tumor size as a continuous measure of response.~   "
125161|NCT01416376|"~     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit~     systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice.~     The objective of this study is to determine the effect of a single administration of~     SRT2379, at multiple-dose levels, on the inflammatory response to low dose endotoxin.~   "
125162|NCT01417416|"~     The relevance of BBB and IB permeability changes as a major precipitating cause for~     cognitive and digestive dysfunction in the military stress setting.~   "
125163|NCT01417403|"~     This phase I trial studies the side effects and best dose of hydroxychloroquine in treating~     patients with solid tumors undergoing radiation therapy for bone metastases. Drugs, such as~     hydroxychloroquine, may make tumor cells more sensitive to radiation therapy~   "
125164|NCT01417390|"~     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus~     concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with~     locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of~     induction chemotherapy using gemcitabine and cisplatin in NPC patients.~   "
125165|NCT01417377|"~     This observational, prospective, multi-centre, single-arm study will evaluate the efficacy~     of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney~     disease previously on treatment with short-acting epoetin alpha. Data will be collected for~     6 months.~   "
125166|NCT01417364|"~     The general hypothesis is that administration of testosterone to healthy, older men for 52~     weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks~     without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle~     strength, muscle mass, and bone density as standard of care (SOC), continuous administration~     of testosterone for 52 weeks.~   "
125167|NCT01417351|"~     Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis~     Medical Center are currently conducting a study on the effects of vitamin D supplementation~     during pregnancy on maternal health and immune function. The investigators believe that~     vitamin D supplementation at levels greater than the current recommendation is beneficial~     for maternal health during pregnancy. In particular, there is evidence that vitamin D~     deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia,~     which may be due to an imbalance in immune function at the placenta. This randomized,~     double-blind study is designed to test this hypothesis. Pregnant women who participate in~     the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their~     pregnancy. The investigators will collect blood at three time points during pregnancy (16-20~     weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D~     status. The investigators are also collecting data on clinical parameters, such as blood~     pressure and glucose tolerance.~   "
125168|NCT01417338|"~     1. To characterize the demographics and clinical course of the patient population~          diagnosed as having WHO group I pulmonary arterial hypertension and WHO group IV~          pulmonary hypertension due to chronic thromboembolic pulmonary hypertension~        2. To describe real-world outcome of Chinese patients with WHO group I pulmonary arterial~          hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic~          pulmonary hypertension~        3. To evaluate differences in patient outcomes according to classification subgroup~        4. To identify clinical predictors of long-term survival~        5. To assess the relationship between targeted therapies for pulmonary arterial~          hypertension and patient outcomes~   "
125169|NCT01417325|"~     The registry study is to obtain the state of the art of the percutaneous coronary~     intervention state treatment for coronary heart disease in Beijing area of P.R.China in a~     real world. The data are collected from 48 hospitals in Beijing area using an uploading~     system through internet.~   "
125170|NCT01417312|"~     This study aims to investigate metabolic effects of a standardized green tea extract,~     containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis~     patients.~   "
125171|NCT01417299|"~     The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201~     has been reported to induce neuronal regeneration in animal models. Evaluation will be done~     by combining clinical /behavioral assessment with fMRI studies.~   "
125172|NCT01417286|"~     This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery~     works in treating patients with breast cancer. RT uses high energy x rays to kill tumor~     cells. Giving RT after surgery may kill any remaining tumor cells~   "
125173|NCT01417273|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for~     next 6 months on disease activity and progression in patients with Multiple Sclerosis.~   "
125174|NCT01417260|"~     Oxytocin is a hormone that is released in response to distension of the cervix and uterus~     during labor, and after breast feeding as a result of nipple stimulation. In addition to~     oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal~     behavior including bonding, social recognition, anxiolysis, sexual arousal.~      The role of oxytocin in pain modulation has recently been highlighted. Intranasal or~     intrathecal (spinal) administration has been found to impact pain modulation. The~     administration of intravenous oxytocin has not provided effective analgesia because oxytocin~     is unable to pass to your brain. The role of breastfeeding on analgesia is poorly~     investigated, which is why we are carrying out this study.~   "
125175|NCT01417247|"~     The purpose of this study is to observe the incident of composite cardiovascular events~     after renal sympathetic modification using THERMOCOOL® catheter in patients with metabolic~     syndrome, and evaluate safety and efficacy of the intervention.~   "
125176|NCT01417234|"~     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care~     System for the treatment of acute trauma and acute surgical excision wounds. The secondary~     purpose will be to compare the prospective patients to retrospectively treated acute trauma~     wounds to further evaluate efficacy and safety.~   "
125177|NCT01417221|"~     The purpose of this study is to observe the incident of composite cardiovascular events~     after renal sympathetic modification using THERMOCOOL® catheter in patients with essential~     hypertension, and evaluate safety and efficacy of the intervention.~   "
125178|NCT01417208|"~     The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound~     therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the~     treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.~   "
125179|NCT01417195|"~     The objective of this study was to compare the fertilization rate between the combination of~     Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered~     subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).~     Additionally the study assessed subjects' ability to mix and store the combination of~     Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.~   "
125180|NCT01417182|"~     Prostate cancer is the most common cancer among men in the United States. Through early~     detection and improved local therapies a large number of men will be cured. The clinical~     needs include early detection, accurate initial staging and detection of local recurrence or~     metastases in order to permit application of the most appropriate therapy. Therapeutic~     monitoring and prognostic assessment are equally important. Imaging can play an important~     and crucial role in meeting these clinical needs.~      Positron emission tomography (PET) imaging has gained an important role in the clinical~     management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific~     membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18~     positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging~     studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer~     cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission~     tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic~     properties that will represent an advance in imaging prostate cancer. This initial phase I~     study will determine the biodistribution, pharmacokinetics, and prostate specific tumor~     uptake in patients with metastatic prostate cancer.~   "
125181|NCT01417169|"~     This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic~     stem cell transplantation. Micafungin is administered until confirmation of neutrophil~     engraftment or treatment failure.~   "
125182|NCT01417156|"~     Primary objective of this study is to investigate the long-term tolerability and safety~     profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary~     Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).~      Secondary objectives are to assess effects on some efficacy criteria during long term~     treatment with BIBF 1120 on top of pirfenidone.~   "
125183|NCT01417143|"~     The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to~     evaluate the efficacy of TKI258 (Dovitinib).~   "
125184|NCT01417130|"~     The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will~     continue observations of the declared primary outcomes of the Alzheimer's Disease~     Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that~     trial.~   "
125185|NCT01417117|"~     Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to~     weakening by age, high blood pressure, and/or elevated cholesterol. In addition to artery~     rupture, recent data suggests that patients with ICH are also at risk for developing~     occlusion of arteries during the acute phase, called ischemic strokes. Data suggests these~     ischemic strokes can negatively impact patient outcomes. Diffusion weighted imaging (DWI) is~     a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic~     strokes in the brain. In this proposal, our primary aim is examine prospectively the effect~     DWI abnormalities have on functional outcomes in patients with ICH. Our hypothesis is that~     the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in~     patients with ICH~   "
125186|NCT01417104|"~     This study is being done to assess the effectiveness of short term (~9 months)~     Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in~     thoracic and abdominal aorta. This will be checked by comparing before and after therapy~     magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved~     drug for hypertension but in this study is used for a new indication. Recent studies with~     animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in~     this study, the investigators would like to evaluate whether the investigational drug~     Aliskiren, which is not FDA approved for this indication has the same beneficial effects in~     people with atherosclerotic disease.~   "
125187|NCT01417091|"~     This is a randomized, open label intra-patient dose escalation study to evaluate safety and~     tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis~     imperfecta (OI).~      Pharmacodynamic effect will be determined by serological biomarkers and radiologic~     assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.~      Twelve to 15 patients will be enrolled.~   "
125188|NCT01417078|"~     The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray~     following a single dose in epileptic patients experiencing a seizure episode.~   "
125194|NCT01416987|"~     This prospective study will collect safety information from more than 600 patients treated~     with Pergoveris®.~      During the Post-Marketing Surveillance (PMS) period, data about the patient´s background,~     patient's medical history, Pergoveris® indication, prior infertility medication, Pergoveris®~     treatment status, concomitant drugs, all adverse events (regardless of the causal~     relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) will be~     collected for study purposes.~      The post marketing surveillance is based on all cases treated with Pergoveris®.~   "
125195|NCT01416974|"~     The purpose of this Phase I study is to test the safety and effect of specially prepared~     cells collected from the patients called modified T cells. We want to find a safe dose of~     modified T cells for patients who have disease remaining after initial chemotherapy. We also~     want to find out what effects these T cells have on you and your leukemia.~   "
125196|NCT01416961|"~     This study is needed to assess the feasibility of integrating this therapy with current~     treatment regimens. If this study shows success a formal phase II test study to conduct~     feasibility will be the next step. The first dose level chosen for this study is 66Gy of~     radiation to the tumor between LET and standard photon therapy. This dose is the current~     standard of care for stage III . If this dose is found to be feasible then the dose of LET~     will escalate to the total dose of 74Gy.~   "
125197|NCT01416948|"~     This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of~     persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or~     traumatic brain injury (TBI).~   "
125198|NCT01416935|"~     The purpose of this study is to determine whether anti arrhythmic medication, specifically~     Amiodarone, is required during the first three months post surgical ablation.~      Hypothesis: Amiodarone will not be required during the first three months as verified by no~     increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm~     at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to~     include patients' first follow up with cardiologist at approximately 3 months post surgery.~   "
125199|NCT01416922|"~     The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the~     management of women who have received an LSIL Pap report to determine whether the test can~     predict which women will progress to more serious cervical disease and which women do not~     have to be monitored as closely.~   "
125200|NCT01416909|"~     The purpose of this research is to evaluate the effectiveness of the Constipation Treatment~     Protocol and to test whether management according to dose of constipation-inducing~     medications or according to on-going assessment is most effective.~   "
125201|NCT01416896|"~     Our preliminary studies have demonstrated that an innovative new design of the hemodialysis~     venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the~     patient) with three jets is superior to the standard venous needle because it decreases the~     velocity and turbulence of the blood when compared with the standard venous needle, it is~     more efficient in the removal of toxins from the blood, and it is safe and effective. More~     importantly, our preliminary studies suggested that the new needle causes less damage to the~     dialysis vascular access and to circulating blood cells and less inflammation and oxidative~     stress. These will decrease medical complications, the high cost of care and death in~     dialysis patients. The current study will corroborate the finding of previous studies.~   "
125202|NCT01416883|"~     The purpose of this study is to investigate the presence or absence of oral mucosal~     absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects~   "
125203|NCT01416870|"~     The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation~     with Casodex commercial tablet (80mg) in Japanese healthy male subjects~   "
125204|NCT01416857|"~     Aim 1: To develop and validate an Emergency Department(ED) Rasch Disability Diagnostic Tool~     (RDDT).~      Hypothesis:~        -  Rasch modeling will provide an instrument with better measurement properties, including~          increased reliability and validity compared to currently available ED measure of~          disability (MOD).~      Aim 2: To conduct a randomized controlled trial to evaluate the utility of the ED-RDDT to~     reduce rehospitalizations in Medicare recipients visiting an urban Emergency Department for~     non-traumatic illness~      Hypotheses:~        -  Compared to the standard screening tool, the ED RDDT will reduce reutilization of the~          hospital (ED visits, hospital admissions, or death) within 60 days of discharge.~        -  The ED RDDT will reduce costs to Medicare, hospitals and patients.~   "
125205|NCT01416844|"~     In this study, anti-OX40 will be given to patients with melanoma to find out how the immune~     system responds to treatment with anti-OX40. It is hoped that this treatment will cause an~     immune response against melanoma resulting in tumor regression, but this is not known at~     this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria,~     viruses and cancer cells.~   "
125206|NCT01416831|"~     The purpose of this study is compare the response rates in patients with metastatic melanoma~     treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation~     therapy.~   "
125207|NCT01416818|"~     The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-Xiaoyao~     Pill (Herb extracts)on depression, compared to placebo and Bupleurum+Ginkgo in patients~     with Parkinson's disease.~   "
125208|NCT01416805|"~     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)~     program for children with anxiety disorders in community health centers. The first phase of~     the study will offer insight into the feasibility of providing this intervention in~     community health centers, while the second phase will compare CCBT to treatment as usual.~   "
125218|NCT01416675|"~     Objective: Studies documenting the prevalence of delirium among critically ill children are~     still rare. Emerging literature from psychiatric specialists reports the prevalence of~     delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely~     to be an underestimation of the true prevalence, as demonstrated in early adult delirium~     literature, especially given the absence of validated bedside tools to diagnose delirium in~     the PICU.~      The primary aim of this study is to validate the German version of the Pediatric Confusion~     Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is~     to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence~     Delirium (PAED) Scale.~   "
125209|NCT01416792|"~     Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB)~     apparatus which takes over the function of the heart and lungs while the surgeon performs~     the necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is~     centrifuged and washed leaving only red blood cells (RBCs) suspended in a saline solution.~     The RBCs are reinfused into the patient as needed by the anesthesiologist. The main problem~     with this technique is that many of the important components of the blood such as plasma~     proteins and clotting factors are discarded through cell washing. This study will explore a~     novel method (multiple-pass hemofiltration) of processing the residual pump blood which will~     allow the patient to receive their own whole blood with minimum waste of important~     components. The newer method of processing the residual pump volume has also been termed~     off-line modified ultrafiltration (off-line MUF) and is similar to the process that the~     kidneys use to filter the blood. It is hypothesized that multiple-pass hemofiltration of the~     residual CPB volume will reduce the occurrence of inflammatory responses, preserve plasma~     proteins, and decrease allogenic blood exposure and improve clinical outcomes as compared to~     centrifugation.~   "
125210|NCT01416779|"~     The overall purpose of this study is to develop and pilot-test a theory-based psychosocial~     supportive finding balance intervention for older, bereaved spousal caregivers of a~     palliative cancer patient.~   "
125211|NCT01416766|"~     This project will develop and test a low-cost approach to using health information~     technology and home monitoring aimed at improving care for chronic conditions, with low~     barriers to adoption in a wide variety of settings - from large group practices using~     state-of-the-art electronic health records to small practices with no more than a computer~     with internet access. Success will lead to a cost-effective approach to improving control of~     hypertension, both among individuals with diabetes and among non-diabetics, which can make a~     substantial contribution to the health of the population of the United States as improving~     hypertension control is estimated to have a greater population health benefit than most~     other health interventions. Success will also set the stage for adaptation of this~     intervention to a variety of other chronic health conditions and further substantial~     improvements in the health of millions of Americans.~   "
125212|NCT01416753|"~     Background: Data generated with the body composition monitor (BCM, Fresenius) show based on~     bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated~     with poor survival. However, removing excess fluid by lowering dry weight can be accompanied~     by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis~     that, in comparison to conventional hemodialysis, blood-volume monitored regulation of~     ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and~     temperature (UTR) will decrease complications when ultrafiltration volumes are~     systematically increased in fluid overloaded hemodialysis patients.~      Methods/Design: BCM-measurements yield results on fluid overload (in liters), relative to~     extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel group,~     cross-over, randomized, controlled clinical trial, we use BCM-measurements, routinely~     introduced in our 3 maintenance hemodialysis centers shortly prior to the start of the~     study, to recruit 60 hemodialysis patients with fluid overload (defined as ≥15% ECW).~     Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups.~     BCM-determined, 'final' dry weight is set as -7% ECW postdialysis, and reached by reducing~     the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis~     sessions (one study phase). In case of intradialytic complications, dry weight reduction is~     decreased, according to a pre-specified algorithm. A comparison of intra- and postdialytic~     complications among study groups constitutes the primary endpoint. In addition, we will~     assess relative weight reduction, changes in residual renal function, quality of life~     measures, and predialysis levels of various laboratory parameters including C-reactive~     protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the~     first study phase (secondary outcome parameters).~      Discussion: Patients are not requested to revert to their initial degree of fluid overload~     after each study phase, Therefore, the cross-over design of the present study merely serves~     the purpose of secondary end-point evaluation, for example to determine patient choice of~     treatment modality. Previous studies on blood volume monitoring have yielded inconsistent~     results. Since we include only patients with BCM-determined fluid overload, we expect a~     benefit for all study participants, due to strict fluid management which decreases the~     mortality risk of hemodialysis patients.~   "
125213|NCT01416740|"~     This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic~     Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in~     patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect~     MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder~     arthroscopy as the gold standard.~   "
125214|NCT01416727|"~     The purpose of this study is to evaluate and compare the effectiveness of two forms of~     clinical skills training for teaching emergency psychiatry skills to doctors who have just~     started to work in psychiatry~   "
125215|NCT01416714|"~     The purpose of this study is to collect and store normal and malignant tissue from patients~     with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer,~     biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer,~     an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients~     with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer,~     biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer.~     To create a database for the collected tissue and allow access to relevant clinical~     information for current and future protocols. To create tissue microarrays for each~     gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas~     cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal~     cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr~     Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the~     coupled patient tissue samples (normal and malignant) and relevant clinical information for~     the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family~     members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins,~     tyrosine/serine/threonine kinase family members, related molecules, and downstream targets~     implicated in the pathogenesis of GI cancers. Examples of molecular testing include~     evaluation of DNA mutation, alternative splice variants, protein expression and~     phosphorylation, and immunohistochemistry on samples. These studies will be correlated with~     clinical information as stated above.~   "
125216|NCT01416701|"~     The purpose of this study is to examine the effect of vitamin D intervention in patients~     with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.~   "
125217|NCT01416688|"~     RATIONALE: Questionnaires that patients can use to assess skin toxicities related to~     treatment may help identify the intermediate-and long-term effects of cetuximab,~     panitumumab, or erlotinib hydrochloride.~      PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in~     patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib~     hydrochloride.~   "
125219|NCT01416662|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with~     pancreatic cancer that has been removed by surgery.~   "
125220|NCT01416649|"~     This study investigates the effect of exenatide, a FDA approved medication for the treatment~     of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be~     studied before and during treatment with Exenatide.~      Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient~     visits over the course of 3-4 months.~   "
125221|NCT01416636|"~     The primary purpose of this study it to determine the effect on 6 minute walking test (MWT)~     distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients~     with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.~   "
125222|NCT01416623|"~     Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and~     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of~     Henatinib in patients with Advanced Solid Malignancies~   "
125223|NCT01416610|"~     This prospective, multi-center, observational study will evaluate the efficacy and safety of~     Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously~     untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance~     therapy. Data will be collected from eligible participants receiving Pegasys and Copegus~     treatment as prescribed by treating physician and treatment-free follow-up period of 24~     weeks.~   "
125224|NCT01416597|"~     The purpose of this study is to consolidate the cross-protection offered by influenza~     vaccines against circulating influenza A or B viruses that are not antigenically~     well-matched to vaccine strains and to determine the degree of cross-protection separately~     for influenza A and influenza B, through a systematic review of the literature.~   "
125225|NCT01416584|"~     The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in~     promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment~     injection heroine users.~   "
125226|NCT01416571|"~     This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine~     GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64~     years, when administered up to 5 years following production.~   "
125227|NCT01416558|"~     Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less~     toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer~     after failure of anthracyclines. However, most patients receive anthracyclines as well as~     taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment~     for patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant~     therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have~     only limited cross-resistant to solvent-based taxanes and might therefore be indicated in~     this setting.~   "
125228|NCT01416545|"~     This study aims to evaluate if a multidisciplinary educational program in primary~     cardiovascular prevention for children could improve the Framingham Score index of their~     parents after one year.~   "
125229|NCT01416532|"~     To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification~     in asymptomatic adults in comparison with conventional risk stratification (CRS) and~     coronary artery calcium scoring (CACS).~   "
125230|NCT01416519|"~     The objective of this study is to assess whether there is a difference between a care~     protocol with the use of incentive spirometry (Voldyne ®) and another with the application~     of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main~     focus of the study is to determine the incidence of pulmonary complications in each~     technique.~   "
125231|NCT01416506|"~     Prospective, non-interventional, multi-center study. 7 investigative centers will involved~     in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae~     isolates collected.~   "
125232|NCT01416493|"~     This is a proof of concept study asking if alkaline phosphatase injections can reduce acute~     inflammation in rheumatoid arthritis patients.~   "
125233|NCT01416480|"~     The aim of this clinical trial is to evaluate the antitussive effect of Theobromine capsule~     300mg in patients with acute bronchitis.~   "
125234|NCT01416467|"~     The late infantile form of galactosialidosis is potentially amenable to treatment by gene~     transfer with an adeno-associated viral vector encoding Protective Protein Cathepsin A~     (PPCA) or by infusion of purified protein. The published literature contains limited~     descriptions of the disease nor is it known how many patients with the disorder are~     potentially available for protocol enrollment. This preliminary study is designed to define~     the demographics and clinical characteristics of the patient population with~     galactosialidosis. Individuals for whom DNA diagnosis has been performed at St. Jude~     Children's Research Hospital (SJCRH) will be contacted telephonically to learn their current~     status. In addition, a letter requesting information regarding patients with~     galactosialidosis will be sent to all pediatric geneticists throughout the United States.~     Selected physicians with expertise in lysosomal storage diseases throughout the world will~     also be contacted. Foundations and Associations for the lysosomal storage disorders will~     also be contacted in an effort to identify additional potential patients with~     galactosialidosis. The information to be collected in this preliminary study will facilitate~     development of specific eligibility criteria for future therapeutic studies.~   "
125235|NCT01416454|"~     The purpose of the study is to assess potential age-related differences on coagulation~     profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The~     investigators will compare coagulation data collected from the study to assess potential~     differences in coagulation parameters for the following age groups: (i) women less than 35~     yrs (ii) women 35 yrs or older.~   "
125236|NCT01416441|"~     The goal of the current trial is to obtain long term efficacy, safety and tolerability data~     of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.~   "
125237|NCT01416428|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and~     safety of oprozomib in patients with hematologic malignancies.~   "
125238|NCT01416363|"~     This study will investigate how 3 types of drug formulations are absorbed by the body. This~     study is termed 'open-label', which means volunteers will be aware of which treatment they~     are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new~     formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in~     this study. Volunteers will also receive a single dose of a formulation used in previous~     trials (reference formulation), so a proper comparison with the new formulations can be~     made. The new fomulations will be administered with food and the reference formulation will~     be given without food. In Part 2, volunteers will receive only one of the 3 formulations as~     a repeat dose for 7 days. Each of these doses will be given with food.~   "
125239|NCT01416350|"~     This is a two part protocol (Parts A and B) in healthy volunteers evaluating the~     pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of~     various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating~     factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide~     (LPS) stimulation) as markers of macrolide anti-inflammatory activity.~      Part A is a randomized, open-label parallel group study evaluating PK/PD of a single~     azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose~     resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of~     azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory~     conditions). This information will guide the range of doses to be studied in a first time in~     humans (FTIH) study of a new chemical entity.~      Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day~     for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil related~     inflammatory conditions. This information will provide insight into whether the biomarker~     effects change over time on repeat dosing and any potential differences observed between~     single and repeat doses.~   "
125240|NCT01416337|"~     A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV~     microtracer study in subjects with solid tumors.~   "
125241|NCT01416324|"~     The purpose of this study is to look at the safety and tolerability of increasing single~     doses of GSK2330672 in healthy volunteers.~   "
125242|NCT01416311|"~     To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects~     receiving the drug until data from a specified number of subjects are accumulated to~     identify factors considered to influence its safety and efficacy.~      <Priority investigation item> Thromboembolism~   "
125243|NCT01416298|"~     Acute Kidney Injury (AKI) is a common clinical problem defined by an abrupt (< 48 hour)~     increase in serum creatinine (SCr) resulting from an injury or insult that causes a~     functional or structural change in the kidney. Despite significant advancements in the care~     of the critically ill child, mortality rates observed in critically ill children who develop~     AKI have not improved. The investigators have shown even small increases in SCr, which is~     the standard kidney function marker, are associated with increased child mortality, even~     when outcome was controlled for significant patient co-morbidity. Furthermore, the~     investigators have also shown that the amount of fluid accumulation observed in critically~     ill children with AKI is independently associated with mortality suggesting that earlier~     dialysis may improve survival. However, the investigators also do not want to dialyze~     patients who don't ultimately need dialysis, as it is an invasive procedure. The data cited~     above highlight the need not only to detect AKI early, but also predict it severity in order~     to optimize clinical decision making with respect to fluid administration and dialysis~     initiation. While substantial research has been expended to validate NGAL as an early marker~     of AKI, it has not been studied in the context of clinical decision support to guide a~     therapeutic intervention. The investigators hypothesize that NGAL levels can be used to~     determine predict which critically ill children will develop severe and prolonged AKI with~     substantial volume overload, thereby providing the clinician with a diagnostic tool to guide~     CRRT initiation.~   "
125244|NCT01416285|"~     Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a~     devastating prognosis, which resembles that of some types of malignant cancer. Despite~     substantial improvements in the management of the disease, the prognosis remains poor~     especially in advanced stages of the disease. For these patients, self-management plan~     includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and~     knowing what to do if signs of deterioration appear, and when to report the changes to~     health. The investigators hypothesize that patients in the heart failure management programs~     that promote self-management by means of intensive education, edema index-assistance, and~     telephone follow-up can improve their functional status and quality of life, as well as the~     biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.~   "
125245|NCT01416272|"~     The objective of this twelve month dispensing study is to evaluate the clinical performance,~     particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.~   "
125246|NCT01416259|"~     This Phase I study will be performed in a double-blind, randomized, crossover design in~     healthy male and female subjects. The central ECG laboratory will be blinded to treatment.~     Every effort will be made to enroll equal numbers of males and females into the study.~      Eligible subjects will participate in a screening phase (within 28 days of the dosing day),~     a treatment phase and a final visit, which will be conducted on discharge from the study.~     Study duration will be 32 days with a total of approximately 12 days of confinement. During~     the resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at~     selected time points to assess potential ECG effects. Blood samples for PK evaluation will~     be collected in conjunction with the ECG time points.~   "
125257|NCT01416116|"~     The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic~     is applied prior to the application of QUTENZA. This is a multi-center, randomized,~     assessor-blinded study which will investigate the use of an oral analgesic as an alternative~     form of pre-treatment for QUTENZA.~   "
125258|NCT01416103|"~     The purpose of the study is to determine whether welfare-to-work schemes combined with~     alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed~     citizens with alcohol problems.~   "
125317|NCT01415336|"~     Capecitabine has shown high efficacy in metastatic and adjuvant settings. This is a~     prospective, randomised trial, to compare the efficacy and safety profiles of~     capecitabine-containing regimen with non- capecitabine-containing adjuvant chemotherapy~     regimens for node negative breast cancer patients.~   "
125247|NCT01416246|"~     Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy)~     or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also~     lower blood counts. Using own cells (special cells called stem cells) to help increase the~     blood counts after high doses of chemotherapy is called autologous stem cell transplantation~     (ASCT).~      Using own stem cells to restore blood counts and other advances in supportive measures~     (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT.~     However, blood counts still decrease for a period of days after high doses of chemotherapy.~     During that time, patients are at greater risk for infections. Studies have shown that the~     faster the blood counts recover after ASCT, the less at risk there is for developing~     unwanted side effects after ASCT.~      Typically during an ASCT, a patient's stem cells are given back to them all at once on a~     single day. In this study, the investigators plan to see what happens when smaller amounts~     of own stem cells are given back to the patient over multiple days. The investigators want~     to find out what effects good and/or bad this will have on the patient and there multiple~     myeloma. Some studies have shown that giving back stem cells over a period of days helps to~     increase bone marrow activity and decrease the time it takes for blood counts to recover~     after ASCT. It is our hope that this new approach may lower a patient's risk of side effects~     and infections, decrease the number of blood transfusions that a patient needs during this~     process, reduce the time a patient has to spend in the hospital, and lower overall treatment~     costs.~   "
125248|NCT01416233|"~     After enucleation or evisceration with placement of a dermis fat graft or integrated orbital~     implant as a primary procedure, there can be secondary loss of orbital fat volume causing~     regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques~     for correction require open surgery to place a sheet/block of biocompatible material or a~     macroaggregate of fat into the orbit to augment orbital volume for permanent correction.~     Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but~     these have proved to be temporary. The current study seeks to show that a permanent~     augmentation of orbital volume can be achieved using a closed cannula injection of~     autologous fat.~   "
125249|NCT01416220|"~     This study is being done to look at how well people respond to two different drug treatments~     for depression. Clinically, people can respond differently to different treatments for~     reasons which are not always clear. Some research shows that people with a family history of~     bipolar disorder or completed suicide may react differently to standard medications used to~     treat depression than those without a family history. The investigators need to know if~     these drugs are effective to use in patients with depression who have a family history of~     bipolar disorder or completed suicide.~   "
125250|NCT01416207|"~     Rationale for the Study:~      The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic~     (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be~     used to support registration of Avonex in China.~      Study Design:~      This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly~     injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood~     samples will be collected with the first and fourth injections of Avonex, and a sparse blood~     sample will be collected with the second and third injections of Avonex.~   "
125251|NCT01416194|"~     This observational cohort study is being conducted to further characterize selected adverse~     events of interest among a patient population with osteoporosis who are prescribed~     bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized~     clinical trial setting. The study will compare the rates of the selected clinical events~     among the three treatment groups.~   "
125252|NCT01416181|"~     This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion~     of the placebo-controlled period (Part 1), participants will have the option of enrolling in~     a 2-year open-label extension (Part 2).~      Part 1: The primary objective of the study is to investigate whether treatment with~     natalizumab slows the accumulation of disability not related to relapses in participants~     with secondary progressive multiple sclerosis (SPMS).~      The secondary objectives of Part 1 of this study are to determine the proportion of~     participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in~     participant-reported ambulatory status as measured by the 12-item MS Walking Scale~     (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of~     natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact~     Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of~     study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants~     experiencing progression of disability as measured by individual physical Expanded~     Disability Status Scale (EDSS) system scores.~      Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of~     natalizumab in participants with SPMS.~      The secondary objectives of Part 2 of the study are to investigate long-term disability~     (based on clinical or patient-reported assessments) in participants with SPMS receiving~     natalizumab treatment for approximately 4 years and to assess change in brain volume and T2~     lesion volume.~   "
125253|NCT01416168|"~     Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a~     higher risk of complications. Some studies indicate that senior cancer patients might~     benefit from a home support after surgery by a geriatric nurse practitioner and a team,~     beside their usual post-operative care. The investigators team is planning a large study to~     assess whether this approach could help patients with colorectal cancer recover better from~     their surgery, get better cancer treatment after that (e.g. chemotherapy), and possibly live~     longer. This study you are asked to take part in is a pilot for this large study.~   "
125254|NCT01416155|"~     The primary objective of the study is to further evaluate the long-term safety and~     tolerability profiles of BG00002 (natalizumab) in Japanese participants with~     relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to~     further evaluate the long-term efficacy profile of BG00002 in Japanese participants with~     RRMS.~   "
125255|NCT01416142|"~     The objective of this study is to evaluate the product performance of PureVision2 HD contact~     lenses.~   "
125256|NCT01416129|"~     The investigators are comparing a new type of prosthetic socket for above knee amputees to~     the standard of care. The hypothesis is that the new type of socket will show equivalence to~     the standard of care using our designated outcome measures.~   "
125259|NCT01416090|"~     Syndactyly is a relatively common congenital abnormality of the hand occurring approximately~     1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are~     shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact~     that there is not enough skin surrounding the two finger segment to be utilized to cover two~     separate fingers. This can also be proven by simple geometry. Therefore, it has always been~     taught to residents and explained to numerous patients' families that addition of skin graft~     is required for a proper syndactyly release. Without it, skin flaps would be too tight,~     causing some necrosis and significant scarring along the finger and particularly in the web~     space, causing an unsatisfactory functional and cosmetic result requiring revision.~   "
125260|NCT01416077|"~     Surgery for cancer of the esophagus is associated with a high risk of postoperative~     complications. It has been shown that the risk of postoperative complications can be~     decreased by optimising the amount and type of infusion fluids given during surgery, steered~     by measurement of cardiac stroke volume, mostly done with a device called esophageal~     Doppler. This device can however not be used during this type of surgery. This study wants~     to test the hypothesis that postoperative complications in patients operated for esophageal~     cancer can be partially prevented by using a goal directed strategy for the administration~     of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume~     by pulse wave analysis (FloTrac).~   "
125261|NCT01416064|"~     Open-label, extension study for subjects that completed 810P202 to examine long term safety~     and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with~     Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
125262|NCT01416051|"~     Today's obesogenic environment, favors behavioral choices that lead to an excess of energy~     intake over expenditure, and consequently weight gain. Intervention strategies that harness~     the body's own appetite and satiety regulating signals could provide an effective means of~     countering excessive energy intake. The purpose of this study was to investigate whether a~     vegetable oil emulsion (Olibra) would result in weight loss that was associated with a~     reduction in food intake.~   "
125263|NCT01416038|"~     This is a phase 1-2 study to determine the safety and immunogenicity profiles of~     DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral~     cyclophosphamide. DPX-Survivac is for the treatment of ovarian, fallopian tube, and~     peritoneal cancers.~      Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to~     destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2,~     and even phase 3 trials. Much has been learned about the principles of applying immune-based~     therapies and specifically the types of patients that may be most likely to mount an~     effective immune response. Cancer vaccines may have their greatest impact earlier in the~     disease course or in situations with minimal residual disease.~      ImmunoVaccine Technologies Inc. (Immunovaccine) is developing therapeutic vaccines against~     various solid cancers based on a patented vaccine delivery and enhancement system.~     Immunovaccine's vaccine formulation, termed DepoVax, is a lipid-based formulation created to~     enhance the speed, strength and duration of the immune response. Immunovaccine's hypothesis~     is that the immune enhancement properties of its formulation are the result of the~     co-delivery of antigen and adjuvant and the created depot effect. The peptide antigens~     included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed~     in many cancer types, including epithelial ovarian cancers.~      This study will begin with a phase 1 safety cohort study; at least 15 non-randomized~     patients will be enrolled into the open-label dose finding study. The study will then~     progress directly into the 2:1 randomized, double-blinded phase 2 portion of the study. The~     phase 2 will be a placebo controlled efficacy study, enrolling approximately 250 patients.~   "
125264|NCT01416025|"~     This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring~     (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary~     objective of this study will be to assess the effect of prospective voriconazole TDM on the~     composite of adverse events (AE) and clinical response.~   "
125265|NCT01416012|"~     Interactive games (virtual reality) have recently been the center of interest and scientific~     discussion in the field of cognitive and functional rehabilitation. From their entertaining~     and contextual aspects, off-the-shelf video games are potentially interesting tools as~     adjunct to the patient care, especially for maintaining instrumental activities of daily~     living (IADL) autonomy.~      Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing~     health related quality of life (HRQL). This decrease in cognitive and functional abilities~     can be slowed down using adapted rehabilitation program.~      However, there is no randomized controlled study comparing usual physical therapy to virtual~     reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.~      Off-the-shelf gaming consoles offer a large range of games where cognitive and functional~     abilities from geriatric patients could be stimulated and consequently HRQL improved.~      However, a better knowledge of the potential cognitive and functional improvement processes~     from virtual reality rehabilitation in institutional routine is needed to enhance the~     quality and the range of the available care in old adults.~      This study will not only be a validation platform of virtual reality as stand alone~     rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming~     consoles in HRQL improvement of old adults.~      The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL~     changes of patients with Alzheimer disease and related disorders.~      •Method~      This study is a randomized controlled trial that comprises two study phases :~      Phase one; comparing three parallel groups where therapists and assessors will be kept blind~     of study objectives, and Phase two, the investigators will take the most cost-effective~     gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will~     use it as an adjunct to physical therapy compared to physical therapy alone, with respect to~     the same amount of rehabilitation time.~      The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after~     intervention.~      Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or~     physical therapy as the 'gold' standard condition.~      All groups will receive the same amount of rehabilitation time. Power and sample calculation~     for phase two will be based on phase one results.~   "
125266|NCT01415999|"~     Anthracyclines have been used commonly to treat children with solid tumours and~     haematological malignancies and have led to their increased survival. Nonetheless,~     anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess~     the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel~     interaction, usefulness of circulating biomarkers in the assessment of heart function and~     potential genetic predisposition to heart failure in adult survivors of childhood cancers.~   "
125279|NCT01415830|"~     The morbidity associated with scorpion sting intoxication presents an endemic pattern in the~     country, where there are highly venomous species of scorpions so the scorpion sting~     intoxication (IPPA) is considered a medical emergency.~      On the other hand, there is scarce scientific literature from different controlled studies~     evaluating anti-scorpion serum, considering clinical severity scales, lab results and their~     safety. The aim of this study is to compare the efficacy and safety of scorpion sting~     treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).~   "
125267|NCT01415986|"~     Presently, there is no effective treatment for patients with advanced head and neck cancer~     (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery)~     in the US. These patients are deemed incurable AHNC. In the European Union (EU),~     interstitial photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of~     patients with incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin~     can provide worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of~     patients with incurable AHNC. This is a significantly higher rate in comparison to the~     reported response rate of palliative chemotherapy (6-30%). However, the EU studies did not~     correlate quantitative tumor response with clinical outcome. In addition, quality of life~     (QoL) improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated.~      The objective of this study is to quantify the tumor response and patient's QoL to I-PDT~     with Temoporfin. Successfully meeting this objective will give us the tools the~     investigators need to design larger studies to significantly improve the management and QoL~     of patients with AHNC.~   "
125268|NCT01415973|"~     This study will compare the effects of cooked, ground beef to those of beef protein isolate~     on blood and muscle proteins.~   "
125269|NCT01415960|"~     Some patients with prostate cancer benefit from androgen deprivation therapy which reduces~     levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone~     (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL.~     Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is~     released slowly over time and effectively reduces testosterone levels in many patients to~     ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be~     administered by intramuscular injection twice over a period of 6 months. The proportion of~     patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.~   "
125270|NCT01415947|"~     The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system,~     consists in the ability to adjust (elongate or shorten) the neochordae off-pump to achieve~     an optimal coaptation. The adjustment mechanism allows overcoming the main problem of~     chordal replacement by enabling accurate sizing of the chords.~   "
125271|NCT01415934|"~     The purpose of this study is to determine if there is a difference in survival rate at 60~     days after enrollment between patients with advanced life-limiting illness for whom statins~     are discontinued vs. for patients with advanced life-limiting illness who are maintained on~     the medication. Secondary outcomes of this study will determine the effects of medication~     cessation on overall survival, important cardiovascular events, quality of life (QOL),~     symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.~   "
125272|NCT01415921|"~     Heart failure, a common heart disease affecting nearly 6 million Americans, is associated~     with high rates of hospitalization and death. Abnormalities in the autonomic nervous system~     are thought to play an important role in the progression of heart failure. This proposal~     aims to determine whether novel application of pyridostigmine, a drug currently approved by~     the FDA only for the treatment of neuromuscular disease, can improve autonomic nervous~     system function in heart failure patients.~   "
125273|NCT01415908|"~     This investigation will provide safety and effectiveness information on the use of INFUSE®~     Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a~     Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent~     levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral~     spine.~   "
125274|NCT01415895|"~     ATNC05 is a combination of two known marketed generic compounds. The investigators~     hypothesize that the combination acts synergistically to reduce chronic radicular~     neuropathic back pain of the cervical, thoracic and the lumbar regions.~   "
125275|NCT01415882|"~     This randomized phase II trial studies how well ixazomib (ixazomib citrate) works in~     treating patients with multiple myeloma that has returned after a period of improvement but~     is not resistant to bortezomib. Ixazomib citrate may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
125276|NCT01415869|"~     The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD)~     patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood~     test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of~     gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over~     time by estimating the proportion of VAD patients with a positive test prior to~     implantation; at one week, one month, three months, six months and one year post~     implantation, and after explantation of the VAD and to evaluate whether presence of any~     abnormal fecal HemoQuant test is predictive of a future major bleeding event.~   "
125277|NCT01415856|"~     The purpose of this study is to determine whether the Torino II device, which emits a pulsed~     electromagnetic field), will help to decrease pain and swelling after knee replacement~     surgery, and thereby decrease the use of narcotic medications after surgery.~   "
125278|NCT01415843|"~     Associated reactions are unintended and involuntary arm movements, normally seen as bending~     of the wrist and elbow, that may occur after stroke when a person is doing something~     effortful such as walking.~      This is the first phase of a study that will investigate the effects that different~     approaches to physiotherapy have on the expression of associated reactions. During this~     phase, current practice among neuro-physiotherapists will be explored in relation to: the~     learning strategies used in stroke rehabilitation, the common interventions used in gait~     re-education, and the strategies adopted for the assessment and management of associated~     reactions.~      The objectives are:~        -  To provide an insight into the learning strategies used by physiotherapists during the~          re-education of walking, including the verbal dialogue that takes place and any~          preferences (overt or subconscious) adopted for one type of learning strategy.~        -  To develop and refine a description of what is meant by the term gait re-education~        -  To provide an insight into how therapists currently manage associated reactions~      This phase of the study will explore these objectives using direct non-participation~     observation of a number of physiotherapy treatment sessions. This will provide an insight~     into the nature of the therapy that takes place for retraining walking(e.g. the types of~     exercises commonly used) and the nature of the learning strategies frequently adopted,~     including the amount and content of explicit verbal instruction and feedback that is~     provided to patients.~   "
125280|NCT01415817|"~     Effective colorectal cancer (CRC) screening relies on early identification and removal of~     both polypoid and non-polypoid lesions with neoplastic potential. The investigators~     hypothesize that an intensive training program designed to enhance both recognition and~     classification of lesions with neoplastic potential, will result in an increase in~     non-polypoid adenoma detection in addition to and independent of an increase in overall~     adenoma detection rates.~   "
125281|NCT01415804|"~     The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis~     versus medical management in patients with dissection of the thoracic aorta.~   "
125282|NCT01415791|"~     The purpose of this study is to investigate the presence or absence of oral mucosal~     absorption of ICI176,334-1~   "
125283|NCT01415778|"~     The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese~     healthy male subjects.~   "
125284|NCT01415765|"~     Background:~      - MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more~     sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective~     in treating some cases of large B-cell lymphoma. This research will look at two things. The~     first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is~     the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell~     lymphoma.~      Objectives:~        -  To study how MLN4924 affects large B-cell lymphoma tumors.~        -  To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R~          chemotherapy.~      Eligibility:~      - Individuals at least 18 years of age who have large B-cell lymphoma that will be treated~     with chemotherapy.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, tumor samples, and imaging studies.~        -  Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each~          cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest~          period. Participants will be monitored with frequent blood tests and imaging studies.~        -  Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R~          chemotherapy for up to six cycles of treatment.~   "
125285|NCT01415752|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer~     cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell~     lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab~     together with bendamustine and bortezomib is more effective than rituximab and bendamustine,~     followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.~      PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and~     lenalidomide in treating previously untreated older patients with mantle cell lymphoma.~   "
125286|NCT01415739|"~     This research studies protein in tumor samples from patients with non-small cell lung~     cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help~     doctors tell what type of lung cancer a patient has and plan better treatment.~   "
125287|NCT01415726|"~     Type 2 diabetes is the most common form of diabetes. The prevalence of diabetes has been~     markedly increased in recent years. More and more children and young adults develop this~     devastating disease. Despite of multiple factors (e.g., food, environmental, and genetic~     factors) contributing to the developing of diabetes, increasing evidence demonstrated that~     chronic inflammation and/or atuoimmunity are common issues and play key roles in the~     pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of~     insulin-producing islet beta cells. Thus, anti-inflammation is becoming a novel approach for~     the treatment of type 2 diabetes. Evidence that multipotent stem cells derived from human~     cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory~     T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers~     promise for a new approach to treat type 2 diabetes. Here, the investigators develop a novel~     Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem~     Cell Educator therapy in T2D patients.~   "
125288|NCT01415713|"~     Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen~     Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary~     objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease~     control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor~     progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study~   "
125289|NCT01415700|"~     The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after~     central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve~     the patient's walking floor by removing the STEPPAGE, reducing the effort of walking,~     facilitating the flow and removing anomalies compensatory (such as the mowing of the hip).~     Its objective is to improve the patient's autonomy locomotor.~      The aim of this study is to compare the results of the implementation of an implanted~     stimulator in the levator muscles of the foot to the results obtained by wearing a~     splint-type reliever, which is considered standard treatment, in order to determine if the~     implanted stimulation may be proposed in the treatment of foot drop off a neurological~     center.~   "
125290|NCT01415687|"~     The objective of this study is to compare the efficacy, safety and tolerability of two bowel~     preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax~     plus Bisacodyl - with a specific emphasis on the right colon cleanliness.~      The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of~     preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes~     will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.~   "
125291|NCT01415674|"~     The purpose of this study is to identify predictive and pharmacodynamic biomarkers of~     activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head~     and neck squamous cell carcinoma patients~   "
125292|NCT01415661|"~     This investigation was designed to assess the patency of the esophageal entrance during~     cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the~     Glidescope ® video laryngoscope (GVL).~   "
125293|NCT01415648|"~     In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an~     ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no~     consensus concerning the best cerebral monitoring and hemodynamic optimisation during~     carotid cross-clamping.~      The objective of this prospective, multicentric, double-blinded and randomized study is to~     evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter~     to direct the hemodynamic optimisation during carotid endarterectomy and reduce the~     new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness~     analysis will be conducted to estimate the impact of this monitoring versus standard care on~     direct and indirect postoperative costs during 120 days.~      A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a~     serum marker of brain injury, protein S-100B~   "
125294|NCT01415635|"~     Background:~      The investigators have previously documented that patients at nutritional risk lack~     sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized~     historically controlled intervention study of 40 patients at nutritional risk. The study~     indicated that a tailored food concept increased nutritional intake in this patient group.~      The objective of the current study is therefore to investigate these findings in a~     randomized clinical trial. Our target is for 75% of patients in the intervention group to~     reach 75% of their energy and protein requirements.~      Methods:~      The study will compare standard nutritional care (control group) with tailored nutritional~     care (the possibility to order small energy and protein-enriched dishes called Delights of~     Herlev Hospital). 96 patients at nutritional risk, according to the NRS-2002 criteria, will~     be included in the study.~   "
125295|NCT01415622|"~     The purpose of this study is to prove the safety and efficacy of plasma as an add-on~     treatment in combination with conventional treatment in cases of chronical venous Ulcus~     cruris.~   "
125296|NCT01415609|"~     The purpose of this study is to monitor the success rates and completion rates for~     endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.~   "
125297|NCT01415596|"~     Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise.~     High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis~     that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and~     recovery during exercise in well-trained athletes.~   "
125298|NCT01415583|"~     Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after~     tonsillectomy is one of the risks of this surgery and can be more dangerous in children~     since they have less blood volume than adults. In order to improve recovery after~     tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given~     during the surgery. Recently, a study showed steroids given at the time of tonsillectomy~     increase the risk of bleeding significantly over children who did not receive steroids. This~     finding has raised concerns in the Ear, Nose, and Throat (ENT) community since most ENT's~     use steroids during tonsillectomy in children. The investigators look to explore this~     question further.~      To answer the question of whether perioperative steroid administration significantly affects~     the rate of post-tonsillectomy bleeding, the investigators propose to test the following~     hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone~     does not cause an increase in post-operative bleeding rate in tonsillectomy.~   "
125299|NCT01415570|"~     In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to~     suffer from chronic kidney disease and need dialysis treatment for life, when compared to~     the non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years~     only less than 35% are still alive. Dialysis patients who appear malnourished or who have~     muscle and fat wasting are even more likely to die. Interestingly, among dialysis patients,~     minorities (African Americans, Hispanics and Asian Americans) usually survive longer than~     the non-Hispanic Whites. If the investigators can discover the reasons for these so-called~     racial survival disparities of dialysis patients, the investigators may be able to improve~     survival for all dialysis patients and maybe even for many other people who suffer from~     other chronic diseases. During this 5 year study the investigators would like to test if a~     different nutrition and diet can explain better survival of minority dialysis patients. The~     investigators will also test if in additional to nutrition there are 2 other reasons for~     better survival of minority dialysis patients, namely differences in bone and minerals and~     differences in social and psychological and mental health. The investigators plan to study~     450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South~     Bay area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic~     Whites and 10% Asians. Every 6 months the investigators will examine their nutritional~     conditions, dietary intake, psycho-social conditions and quality of life, and will recruit~     75 new subjects to replace those who left our study as a result of kidney transplantation,~     death or other reasons. Hence, the investigators estimate studying a total of 1,050~     hemodialysis patients over 5 years. Clinical events such as hospital admissions and survival~     will be followed. Blood samples will be obtained every 6 months for measurements of hormones~     and biomarkers, and the remainder of the blood will be stored in freezers for future~     measurements. The investigators plan to design and develop race and ethnicity specific~     nutritional risk scores and food questionnaires and will test some of these scores in larger~     national databases of hemodialysis patients. Almost a year after the study starts, the~     investigators also plan to do additional tests of body composition and dietary intake in a~     smaller group of these patients at the GCRC.~   "
125300|NCT01415557|"~     The purpose of this study is to assess the impact of regular consumption of micronutrient~     fortified drink in improving nutritional and micronutrient status in Indian school children.~     The test beverage will be fortified with both, vitamins and minerals.~   "
125301|NCT01415544|"~     The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based~     method for measuring glucose concentration relative to invasive blood reference~     measurements. The initial phase of the study will be focused on procurement of the data~     needed to develop a robust, accurate calibration. The second phase will be focused on~     performance evaluation of the system.~   "
125302|NCT01415531|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of~     therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age~     with stage 1 or stage 2 essential hypertension.~   "
125303|NCT01415518|"~     Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD)~     patients.~   "
125304|NCT01415505|"~     The purpose of this study is to evaluate the safety and tolerability of nebivolol and~     valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential~     hypertension.~   "
125305|NCT01415492|"~     This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy~     Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target~     cancer prevention among multi-ethnic populations; it led to significant improvements in the~     multiple risk behavior score (consumption of red meat, fruits and vegetables, and~     multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to~     include smoking and physical activity. In addition, it expanded the study goals to include~     increasing efficacy across all target risk behaviors, and promoting long-term maintenance of~     behavior change.~   "
125306|NCT01415479|"~     Fifty thousand people die from colorectal cancer (CRC) every year, making it the second~     leading cause of death from cancer in the United States. And although there are multiple~     screening tests that reduce the morbidity and mortality of this disease, less than 60% of~     eligible individuals are up to date with recommended screening.~      One of the challenges to improving screening is helping patients understand the range of~     approved tests, including colonoscopy, sigmoidoscopy, and stool testing (such as fecal~     immunochemical testing (FIT)). Patients rarely consider all their options, partly due to the~     limited time they have to learn about them during busy doctor's visits.~      Computer-based presentations, including decision aids, are a promising tool for improving~     patient understanding in this and other areas, by giving patients significant amounts of~     information.~      But there are important questions about how to design such presentations, including whether~     they should provide quantitative data about the risks and benefits of screening. Some~     experts feel that these numbers and graphs are necessary for fully informed decision-making,~     while others are concerned that they may confuse patients or dissuade them from screening.~      The investigators have created and pilot tested a computer-based presentation of~     quantitative information about CRC screening. The investigators found that subjects who~     viewed the program in a non-healthcare setting exhibited significantly increased interest in~     screening. In addition, the investigators tested a version of the program that includes a~     nudge towards stool testing with FIT, as a way of encouraging individuals who are confused~     to undergo some form of screening. In our testing, receiving the nudge was associated with a~     significant increase in interest in FIT.~      The investigators now seek to conduct a randomized, controlled study of our computer-based~     presentation with Clarian patients who are due for CRC screening. All subjects will first~     view a general video about CRC screening and then will be randomly placed into four groups~     (using a 2x2 design), to receive quantitative information (or not), and a nudge towards FIT~     (or not).~      The results will determine whether a presentation of quantitative information can increase~     patient understanding, quality of decision-making, and uptake of CRC screening. The results~     will serve as pilot data for a larger, externally funded study of the effect of~     individualized (personalized) quantitative information in this area~   "
125307|NCT01415466|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between rosuvastatin and CS-866 in healthy male volunteers.~   "
125308|NCT01415453|"~     Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect~     the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor~     cells (cells in the retina that detect light). Photoreceptor cells capture and process light~     helping us to see. As these cells breakdown and die, people experience progressive vision~     loss. There is no known cure for retinitis pigmentosa. The investigators have observed that~     short pulses of focused ultrasound can cause perception of light when directed to spots on~     the retinal surface. The investigators propose to conduct a study to determine if pulsed~     ultrasound will stimulate the perception of light in the absence of functional~     photoreceptors in people with RP~   "
125309|NCT01415440|"~     The aim of this study is to examine the mechanisms by which stimulant medications reduce~     symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic~     Resonance Imaging (MRI), the investigators have found that the volumes of certain brain~     regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if~     patients had been treated with stimulant medications, suggesting that stimulants may reduce~     the symptoms of ADHD by reversing these volume reductions. In a second and related study,~     the investigators found that in patients with ADHD, emotional processing was normalized when~     patients were taking stimulant medications. Both studies point to possible mechanisms by~     which stimulants are effective; however, a significant limitation of these findings is that~     they were derived from cross-sectional studies.~      In this current study, the investigators hope to replicate these treatment effects of~     stimulants in a prospective, controlled manner. The investigators plan to measure ADHD~     symptom severity in patients before and after 12-weeks of controlled treatment with either a~     stimulant medication or placebo while utilizing structural and functional MRI. Combining~     imaging with a randomized controlled trial will allow us to better assess the effects of~     stimulants on brain function and structure.~   "
125310|NCT01415427|"~     This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0~     mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis~     IVA (Morquio A Syndrome).~   "
125311|NCT01415414|"~     It is a prospective, non-interventional, multi-center study. The primary objective of this~     study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced~     CT considering the routine use in patient population's, region's indication.~   "
125312|NCT01415401|"~     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®~     from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients~     with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).~   "
125313|NCT01415388|"~     The purpose of this study is to assess the effect of 12 weeks of daily supplementation with~     Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects~     whose habitual fatty fish and seafood intake is low and who have borderline high or high~     fasting serum triglyceride levels.~   "
125314|NCT01415375|"~     This study evaluates the efficacy of a tailored telephone intervention to promote informed~     decision making about prostate cancer testing among predominantly immigrant black men.~   "
125315|NCT01415362|"~     In this pilot study, the researchers investigated the feasibility of a closed-loop~     electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for~     treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation~     within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle~     determination of whether tDCS applied during this vulnerable period may be feasible to~     prevent the oncoming seizure.~      This study required 5 visits over the course of approximately 8 weeks. Each visit was~     separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During~     these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when~     seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects~     received active stimulation or sham stimulation sessions during the first 24-hour visit, and~     the opposite during the second. The subjects were randomized and counterbalanced.~      We have also added a healthy subjects cohort to assess the feasibility of the closed loop~     system. In order to test the proof-of-concept of this system, the experiment will focus on~     detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is~     being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6~     subjects who will have 2 visits each. During these two visits subjects will be randomized to~     active or sham stimulation sessions and receive the opposite during their second visit.~   "
125316|NCT01415349|"~     This is a drug interaction study evaluating whether blood plasma concentrations of~     SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.~   "
125407|NCT01413048|"~     The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in~     patient with stage 1 to 2 essential hypertension.~   "
125318|NCT01415323|"~     Agitation is associated with a number of acute psychiatric conditions, and frequent in acute~     psychiatric admissions. It is associated with violence towards others, and strongly~     associated with in-patient suicides.~      The main aims of the study are to assess different clinical presentations of agitation at~     admittance, and to assess the consequences of these different clinical presentations during~     the first three days of the stay.~   "
125319|NCT01415310|"~     QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry.~     The objectives of the register are to enhance our knowledge of old persons with severe~     psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for~     these patients. The data in the register will be used for quality assurance and for~     research.~      Aims:~        -  Quality assurance~        -  Further development of our diagnostic and screening tools~        -  Contributing to improving the treatment, with and without drugs~        -  Contributing to improving the dialogue and collaboration between primary healthcare and~          hospitals~   "
125320|NCT01415297|"~     The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339,~     a ruthenium containing compound administered intravenously on a weekly schedule, in patients~     with advanced solid tumors. The responses to treatment in this population will be evaluated.~     In addition, the PD and PK properties of the compound will be explored.~   "
125321|NCT01415284|"~     The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4~     which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women~     undergoing a cesarean section under spinal anesthesia.~   "
125322|NCT01415271|"~     The incidence of type 2 diabetes in long term care facilities has been approximated at 25%~     with barriers to treatment including untimely access to a specialist and improper/poor~     adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving~     overall glycemic control by using an internet blood glucose reporting system to facilitate~     bi-weekly consultations between long term care facility patients with type 2 diabetes and an~     endocrinologist.~   "
125323|NCT01415258|"~     The objective of this study is to uncover the prevalence of vulnerability among patients~     aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to~     the short screening test Vulnerable Elders Survey 13 (VES-13).~      The objective is to better understand the value of routine screening of patients before the~     consultation, it was proposed as a secondary objective of this study to assess the~     correlation between the identification of the vulnerability in the screening test VES-13 and~     the identification made by the clinician during the consultation. The correlation between~     VES-13 and opinion of the clinician for three categories of patients (self - intermediate -~     fragile) will also be studied.~   "
125324|NCT01415245|"~     Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and~     effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in~     patients with coronary heart disease.~   "
125325|NCT01415232|"~     The purpose of this study is to determine the correlation between actual epidural needle~     depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate~     epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women~     with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the~     best of our knowledge the use of an epidural depth equation, which was developed in an~     earlier study using height and weight, with ultrasound visualization will improve~     identification of the epidural space.~   "
125326|NCT01415219|"~     The purpose of this study is to evaluate the efficacy of an active rehabilitation program on~     disability and quality of life of patients affected by dermatomyositis and polymyositis.~   "
125327|NCT01415206|"~     This study is a randomized, controlled, multiple risk intervention pilot study evaluated~     with clients recruited from VA Medical Center Substance Abuse Programs. The intervention~     combines an innovative online system with interpersonal MI-based coaching delivered in 4~     sessions over 12-months time.~   "
125328|NCT01415193|"~     The purpose of this study is to analyse the ability to selectively block the posterior~     tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of~     blocking the posterior tibial nerve will give the same post-operative pain relief after~     total knee surgery compared to a sciatic nerve block.~   "
125329|NCT01415180|"~     Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct~     from adult medicine, there exists a large knowledge gap regarding long term health related~     quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of~     sepsis outcomes data is critical because failure to identify children at risk for sepsis~     associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine~     efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis~     associated HRQL/FS deterioration may impede development of novel, effective interventions~     for these children. For the first time the LAPSE investigation will quantify deterioration~     of HRQL/FS among children surviving sepsis. We will measure the incidence, magnitude and~     duration of HRQL/FS alterations associated with pediatric septic shock, and examine~     clinical, sociodemographic, and parent/family factors potentially associated with such~     adverse outcomes. Because sepsis affects a heterogeneous group of children, long term~     morbidity associated with sepsis likely depends on premorbid health status and parent,~     family and home characteristics, as well as children's clinical course during sepsis~     critical illness. Mechanisms underlying adverse sepsis outcomes among children are poorly~     understood at this time. Clinically multiple organ dysfunction syndrome (MODS)has been~     clearly linked to sepsis mortality. To begin to understand pathophysiology underlying~     pediatric sepsis morbidity, this investigation will seek to identify evidence for~     association of HRQL/FS alterations following sepsis with intensity and duration of sepsis~     mediated organ dysfunction as well as with pre-existing comorbidities and parent, family,~     and home characteristics. Thelong term goal of this research program is to timely identify~     children at high risk of sepsis mediated HRQL/FS deterioration and ultimately to design~     effective interventions to minimize such risk. The primary objectives of this investigation~     are to comprehensively characterize HRQL/FS trajectory and to critically examine the~     potential role of sepsis mediated organ dysfunction as well as pre-existing comorbidities~     and parent, family,and home characteristics as risk factors for the adverse outcomes. The~     central hypothesis is that intensity of sepsis organ dysfunction will predict magnitude of~     HRQL/FS deterioration. We also hypothesize that the trajectory towards baseline HRQL/FS~     following the sepsis event will also depend on pre-existing co-morbidities and parent,~     family, and home, and characteristics. Knowledge of these potential mechanisms will~     ultimately facilitate development of targeted interventions to maximize HRQL/FS among~     children surviving sepsis.~   "
125330|NCT01415167|"~     The purpose of this registry is to collect information on patients who are receiving~     treatment with Proleukin in an organized way, and to learn more about patient care during~     and after treatment.~   "
125331|NCT01415154|"~     The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial~     Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic~     worsening in patients who have shown a clinical response to acute TMS treatment.~   "
125408|NCT01413035|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2~     diabetes.~   "
125332|NCT01415141|"~     Chronic hepatitis C is a major cause of liver disease and is thus an important public health~     problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to~     treatment with a combination of peginterferon and ribavirin, the most common form of the~     virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been~     approved by the Food and Drug Administration to be given in combination with peginterferon~     and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C~     to that seen with other more responsive hepatitis C genotypes treated with only~     peginterferon and ribavirin. However, telaprevir has additional side affects such as rash~     and anemia that may limit its usefulness. Intriguingly, about one third of patients infected~     with genotype 1 hepatitis C, who have a specific variation (polymorphism) in the DNA~     sequence (CC) near an immune response gene (IL28B), in fact are highly responsive to 2-drug~     treatment with peginterferon and ribavirin. This raises the possibility that individuals who~     have the IL28B CC polymorphism may not need to be treated with the addition of telaprevir~     and could therefore be spared unnecessary side effects. Thus, the purpose of this study is~     to determine among genotype 1 hepatitis C patients with the IL28B CC polymorphism the~     success rate and side effects of 3-drug treatment compared with 2-drug treatment.~      In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC~     polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and~     ribavirin or with only peginterferon with ribavirin. These medications and the procedures~     involved, including patient history, physical examination, and obtaining small volume blood~     specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard~     management of hepatitis C treatment. All patients will be monitored during treatment with~     periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24~     weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment~     and 25 weeks after stopping treatment). The success of treatment will be judged by the~     presence or absence of detectable virus in blood, as measured by a sensitive diagnostic test~     (PCR). The data to be generated will include measurement by PCR of hepatitis C viral loads~     before, during, and after treatment, as well as reporting of adverse drug effects.~   "
125333|NCT01415128|"~     This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine~     when administered with a single oral dose of avanafil in healthy male subjects.~   "
125334|NCT01415115|"~     The trial is designed as a feasibility study to determine the correlation of noninvasive~     measurements of AGE with the SCOUT device to diabetes complications.~   "
125335|NCT01415102|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time~     course of plasma concentration of single inhaled doses of PF-05212372.~   "
125336|NCT01415089|"~     The purpose of this pilot study is to develop a personalized, interactive, and web-based~     module for cancer patients and a family caregiver. The three-session module will be designed~     to help patients and family caregivers improve their communication and support.~   "
125337|NCT01415076|"~     Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon~     distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted~     through the lungs. This reduces the effects of colonic distension and minimizes intracolonic~     gas at the end of the examination. The aims of the study were to evaluate the timing of~     administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.~   "
125338|NCT01415063|"~     The combination of transcatheter arterial chemoembolization (TACE) with RFA has also~     reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have~     better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for~     small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies to~     assess whether TACE combined sequentially with RFA is more effective than RFA alone for the~     treatment of HCC recurrence after curative treatment. We hypothesized that the combination~     of TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of~     this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone~     for the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in~     the remnant liver, distant from the resection or ablation site after curative treatment of~     RFA or hepatectomy.~   "
125339|NCT01415050|"~     Multicentered, randomized study of safety and efficacy of whole-body vibration (WBV) as add~     on to standard pharmacological treatment of osteoporosis (alendronate 70 mg/ week or~     raloxifene 60 mg/day) in post-menopausal women.~      After informed consent of the patients has been obtained, each patient's potential~     eligibility will be assessed during a Screening Visit. Eligible subjects will be~     stratified into two groups: those that are on treatment with alendronate and those that are~     on treatment with raloxifene.~      Subsequently, at baseline, the patients in each group are randomised to receive either WBV~     or no WBV during the first segment of the study. Baseline evaluation of biomarkers of bone~     remodelling, fall risk and back pain will be performed before starting the first segment.~     Patients will return for efficacy and safety evaluations at week 3 and week 6. At 6 weeks~     after baseline the second segment of the study starts: patients that were on WBV during~     segment I will be observed for another 6 weeks without WBV, whereas the patients that did~     not receive WBV during segment I will now be treated with WBV for 6 weeks in segment II. All~     patients will return for additional visits at week 9 and 12 for safety and efficacy~     evaluation.~   "
125340|NCT01415037|"~     The objective of this research is to improve the care of ocular disease and disorders, in~     particular the changes in the eye associated with diabetes, by providing clinicians with~     dramatically improved ultrasonic images of the entire eye. The research combines advanced~     high-frequency, high-resolution ultrasonic annular arrays transducers with new processing~     techniques designed to overcome several limits that have been reached with conventional high~     frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using~     annular arrays can be more effective than the conventional ultrasound images by at least~     50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will~     be detected with the annular arrays.~   "
125341|NCT01415024|"~     Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2~     ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral,~     gaining a responder rate of approximately 70%. However, the physiological agitation of the~     left ventricle takes place over two pathways. Therefore single point stimulation might be~     insufficient for a dilated, insufficiently and asynchronously contracting left ventricle,~     resulting in either insufficient or no response to the therapy.~      In the CRT ICD Dual LV study the patients receive a second LV lead in an anterior vein.~     When this lead is placed, temporary dual LV stimulation is started. To assess the~     effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement~     is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both~     leads permanently. If not they will be stimulated conventionally.~      The patients participating in this study are monitored for 12 months after implantation.~   "
125342|NCT01415011|"~     The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW~     2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and~     have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.~   "
125343|NCT01414998|"~     There are currently two sensorimotor replacement products which may be of benefit in smoking~     cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the~     purpose of this project is to investigate whether these replacements can help to alleviate~     tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be~     separated into two studies, following the same design and procedures.~      Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy~     of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool~     (e.g. stress ball) which provides no smoking-related cues.~      Study 2 will investigate whether sensorimotor replacements which are more proximal to~     smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a~     replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).~      The investigators hypothesise that the EC will be more effective at reducing withdrawal~     symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the~     Denic will be more effective than the EC.~   "
125344|NCT01414985|"~     The investigators propose to assess the safety and efficacy of a new administration method~     to deliver a biologic to children with a form of Batten disease using an experimental gene~     transfer procedure. This gene transfer procedure consists of delivering a good copy of the~     mutated gene to the nerve cells via a virus. These children are born with genetic changes~     called mutations that result in the inability of the brain to properly recycle proteins. The~     recycling failure leads to death of the nerve cells in the brain and progressive loss of~     brain function. Children with Batten disease are normal at birth but by age 2 to 4 have~     motor and vision problems which progress rapidly to death at age approximately 10 years old.~     There are no therapies available to treat the disease.~      The investigators previous clinical trial used a virus called adeno-associated virus 2~     (AAV2) as the gene delivery system. That study showed that viral delivery of the gene was~     safe and showed small, but significant benefits to the recipient. The investigators~     currently have an IRB approved protocol which uses a slightly different virus called~     AAVrh.10 as the gene delivery system. This 3rd protocol proposes to use the same virus~     AAVrh.10 as the gene delivery system and has expanded the eligibility criteria.~   "
125345|NCT01414972|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate) or placebo for 4 months on gene expression of T CD4+~     lymphocyte in atherosclerotic patients(documented with angiography).~   "
125346|NCT01414959|"~     The investigators will measure the pharmacokinetics of doripenem in skeletal muscle,~     subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care~     patients.~   "
125347|NCT01414946|"~     Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may~     result in a longer hospital stay and a higher rate of complications. This problem is~     especially important for patients after surgery for bowel cancer because cancer itself~     causes a waste of muscle protein. Anesthesiologists can decrease these negative effects of~     surgery by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar~     and protein). Our group recently observed that optimal pain relief with epidural catheters~     (these are placed in the so called epidural space, which lies between the spine and the skin~     of the back) in combination with a low calorie protein diet intravenously (through the vein)~     maintains the body's protein stores after bowel surgery.~      The goal of our new research program is to find out whether this protein saving effect~     depends on how protein depleted the patient is before surgery. In other words we would like~     to answer the question: do cancer patients who show protein wasting before the operation~     benefit more from feeding than patients who show no signs of protein wasting? A second goal~     of this program is to find out if we need to use sugar as part of the diet or whether the~     infusion of protein alone is sufficient. Just giving protein would make feeding not only~     easier but also would avoid the increase in the patient's own blood sugar during and after~     the operation, which typically occurs when sugar is given intravenously during that period.~   "
125348|NCT01414933|"~     High sensitivity to targeted agents has been observed in patients whose tumor cells present~     a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR~     mutations) together with addiction to the given target. More recently, activation of~     alternative pathways (Kras mutation, PI3K mutations) have been reported as a common~     resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).~      From these data has emerged the hypothesis that identification of the deregulated pathway~     through new molecular tools could allow to propose a more tailored targeted regimen.~      Based on these concepts, numbers of phase I/II trials enrich their populations in patients~     presenting specific molecular alterations.~      High throughput technologies (array CGH, sequencing, gene expression array) identify~     deregulated genes. In addition, these technologies determine whether such genomic~     alterations are single (expected efficacy of single agent) or multiple (rationale for~     combination). In a pilot study that included 135 patients, we recently performed a~     combination of array CGH and hot spot mutation array in order to drive patients into phase~     I/II clinical trials. This study led to the conclusions that high throughput technologies i.~     are feasible (80%) and robust, ii. identify targetable genomic alterations in around 40%~     of samples.~      In the present study, the investigators will perform high throughput technologies to drive~     400 metastatic breast cancer patients into specific phase I/II trials.~   "
125349|NCT01414920|"~     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily~     (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus~     (T2DM).~   "
125350|NCT01414907|"~     The purpose of this study is to evaluate the effect of adding the Health Promotion~     activities and rehabilitation to the usual alcohol and drug interventions on the outcome for~     alcohol and drug abusers compared to the usual intervention alone.~   "
125351|NCT01414894|"~     The purpose of our study is to determine how well Triple-H works and how safe it is. The~     investigators are hoping to determine the effects of starting the therapy early and to~     explore if hypervolemia and/or hypertension are beneficial, and what the optimal target~     ranges are.~   "
125414|NCT01414257|"~     This Investigation is to be performed for the purpose of assessing the following information~     in the long-term post-marketing daily medical practice in the patients who receive~     REUMATOLEX 2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher~     than 8 mg/week.~        1. Condition of occurrence of ADRs~        2. Factors considered to affect safety~        3. Verification of efficacy~   "
125352|NCT01414881|"~     The primary objective of this Phase I exploratory study is to determine the effects of~     mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density~     lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening~     Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment~     Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total~     duration of any given subject's participation will be approximately 40 weeks.~   "
125353|NCT01414868|"~     Background: Therapeutic outcomes of leukotriene receptor antagonist (LTRA) vary in~     asthmatics，and there's not an ideal and simple way for prediction at present.~      Objective：To investigate whether leukotriene D4 bronchial provocation test (LTD4-BPT) could~     be an indicator of actual therapeutic outcome of LTRA.~      Methods：A single centre, open-labeled trial was performed in 32 asthmatics with positive~     LTD4-BPT result for a month. All subjects were categorized according to airway~     responsiveness to leukotriene D4（PD20FEV1-LTD4）. Subjects received montelukast therapy~     (10mg, once per night), and reassessment was performed (3~5) days after withholding LTRA.~     The primary end-point was the difference in monthly PEFR. Secondary endpoints included the~     difference in FENO, PD20FEV1-LTD4, PD20FEV1-MCh, pre-test FEV1, ACT score, AQLQ symptom~     score, week 4 PEFmax and PEFmin as compared with week 1, gradual decrease in the use of~     salbutamol and the days without using salbutamol.~   "
125354|NCT01414855|"~     This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab~     [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine,~     Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients~     will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle,~     during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP~     chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug~     interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional~     cohort of approximately 15 patients are planned to be enrolled at a subset of~     investigational sites.~   "
125355|NCT01414842|"~     Aim of the present randomized controlled multinational trial is the comparison of a novel~     biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy,~     with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic~     overall and cardiovascular stability.~   "
125356|NCT01414829|"~     Gastric biopsies will be taken to compare different methods of H.pylori disclosure.Standard~     methods will be compared to culture.~   "
125357|NCT01414816|"~     To identify problems/questions about following items in the clinical practice using~     Betaferon~        1. Unknown adverse event (especially serious adverse event)~        2. Identification of adverse event occurred in the real practice~        3. Factors that may affect the safety of drug~        4. Factors that may affect the effectiveness of the drug~   "
125358|NCT01414803|"~     Although the combination of statin and fenofibrate is one of the options for patients with~     combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In~     this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and~     rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney,~     blood glucose control, and blood cell counts.~   "
125359|NCT01414790|"~     The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation~     could prevent infraauricular depressed deformities and Frey's syndrome following total~     parotidectomy.~   "
125360|NCT01414777|"~     The investigators hypothesize that given prophylactically, intravenous ondansetron will~     attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.~      Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in~     preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo~     elective caesarean section will be enrolled.~      Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous~     ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of~     saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy~     will randomize and dispense study drug.~      Baseline measurements of vital signs will be taken. Otherwise standard management will then~     be used:~        -  Patients must be NPO for 8 hours~        -  Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3~          minutes, more frequently if decided by the provider.~        -  Standard lumbar puncture in a sitting position the L3-L4 or L4-L5~        -  Whitacre pencil-point, 25 gauge~        -  Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20~          mcg fentanyl~        -  Immediately after completing the subarachnoid injection, patients will be laid supine~          with left lateral uterine displacement~      The sensory level of anesthesia will be assessed in the standard fashion every five minutes~     using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0,~     no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee~     [only feet]; 3, inability to move any joint in the legs).~   "
125361|NCT01414764|"~     The aim of this study is to establish if the application of autologous conditioned plasma~     (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon~     repair beginning within two weeks of surgery, can improve patient outcomes over the course~     of 12 months. These outcomes will be measured by post-surgical pain and function scores,~     shoulder strength and range of motion (ROM), and radiological parameters of tendon healing.~     Outcome measures will be compared to a control group of patients receiving placebo~     injections following surgery (saline plus local anaesthetic).~      This study is significant for being the first double blind randomised control trial, using~     two PRP injections to examine the efficacy of a PRP preparation following surgical repair of~     supraspinatus tendon. The objective is to prolong and enhance the tendon healing response~     initiated by surgery.~      The research hypothesis is that enhanced tendon healing following the PRP injections will~     lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon~     compared to the control group.~   "
125409|NCT01413022|"~     This phase I trial studies the side effects and optimal dose of PF-04136309 when given with~     combination chemotherapy (FOLFIRINOX; 5-fluorouracil, leucovorin, irinotecan, oxaliplatin)~     in treating patients with locally advanced or borderline resectable pancreatic cancer. These~     patients are not candidates for surgical resection which is the most effective treatment for~     pancreatic cancer. Giving PF-04136309 together with FOLFIRINOX may shrink pancreatic tumors~     in some patients so that surgery becomes an option~   "
125362|NCT01414751|"~     Few studies have explored how specific formats of effectiveness information effect on real~     patients' decisions. We only know little about what kind of format would be the optimal to~     help patients make well-informed real-life decisions corresponding to their preferences.~      The trial is developed in a clinical randomised design to study risk communication in the~     shared decision making between general practitioners (GP) and their patients in primary~     prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about~     treatment effectiveness and their patients' values on patients' tendency to accept and~     adhere to the treatment as well as their feeling of content with the choice made. GPs are~     randomised to inform about risk and treatment effectiveness by means of either absolute risk~     reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer~     questionnaires concerning their content with decisions and reflections. Patients' redemption~     of prescriptions during the following week and the first year are recorded through an~     electronic database.~      57 GPs and 248 patients have been enrolled in the trial.~   "
125363|NCT01414738|"~     The investigators hypothesize that avoidance of the hippocampal region with WBRT may delay~     or reduce the onset, frequency, and/or severity of NCF decline, as measured with clinical~     neurocognitive tools.~   "
125364|NCT01414725|"~     The primary purpose of this study is to determine whether a 12 week Pilates based core~     stability training programme is effective in improving balance, mobility and balance~     confidence in ambulant individuals with Multiple Sclerosis (MS).~   "
125365|NCT01414712|"~     The purpose of this study is to determine if a non-invasive cancer treatment, high-dose~     stereotactic body radiotherapy (SBRT), is associated with changes in circulating tumor cells~     counts in patients with low- and intermediate-risk prostate cancer.~   "
125366|NCT01414699|"~     The purpose of this study is to determine the extent to which manipulation of dietary~     variety and course sequence affects fruit intake and overall energy intake in preschool-aged~     children.~   "
125367|NCT01414686|"~     More than half of individuals post-stroke have residual movement disabilities, including~     reduced mobility, balance, and increased risk of falling. There is a need for innovative,~     long-term and economically-feasible interventions for those with chronic stroke. Recently, a~     focus has been placed on the use of virtual reality and interactive gaming as a low cost and~     effective manner of treating movement disorders. Yet few studies have investigated~     interactive gaming platforms effect on balance following stroke. The proposed study is a~     randomized, single-blind, control group cross-over study for individuals with chronic stroke~     designed to examine an innovative therapeutic approach by investigating the effects of~     commercially-available gaming systems on balance, mobility and fear of falling in a sample~     of individuals with chronic motor deficits following stroke.~   "
125368|NCT01414673|"~     We recently reported the superiority of the natural cycle to a natural cycle controlled by~     the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed~     embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on~     endometrial receptivity.Based on the above findings we conducted the first prospective study~     that assesses whether there is a difference in pregnancy rate after intrauterine~     insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise~     compared to natural cycles controlled by hCG for final ovulation.~   "
125369|NCT01414660|"~     Three different white adipose tissue-related disorders, whether due to its excess (obesity),~     absence (lipoatrophies) or aberrant distribution (lipodystrophies), are paradoxically able~     to induce metabolic insulin resistance syndrome. The respective roles played by quantitative~     and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle~     insulin resistance, low-grade fat inflammation and immune alterations are not yet perfectly~     understood. In contrast to most organ transplantations that are often complicated by~     post-transplantation diabetes, diabetes cell therapy is associated with body weight loss,~     which is possibly related to the antiadipogenic effects of mTOR inhibitors (rapamycin or~     sirolimus). The aim of this study is thus to determine and monitor blood interleukin-7 and~     other cytokine levels; metabolic parameters; and fat mass distribution with DEXA and RMN,~     before and after a immunosuppressive regimen in patients receiving different kinds of~     transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before~     transplantation. In these patients, blood samples will be taken before and after~     transplantation, as will adipose tissue during the transplantation surgery, in order to~     constitute a plasma serum, gene and tissue bank for improving our knowledge of disorders~     linking fat mass, insulin resistance and immunity, especially post-transplantation diabetes.~   "
125370|NCT01414647|"~     Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on~     the studies made in animals or cell cultures. The findings regarding the possible decrease~     of low-grade inflammation are existing also in humans. Low-grade inflammation has been~     suggested to be a mechanistic link between obesity and its consequences on cardiometabolic~     health. The aim of the present study is to examine the effect of diet rich in berries on~     glucose and lipid metabolism and inflammatory markers.~   "
125371|NCT01414634|"~     Open-label, single center, phase I clinical trial to assess the safety, tolerability and~     preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous~     peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven~     immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS~     patients.~   "
125372|NCT01414621|"~     The purpose of this study is to evaluate whether angiogenesis is decreased in diabetic~     patients with coronary artery disease compared to non-diabetics with coronary artery~     disease. The protein expression of angiogenic factors will be examined in atrial tissue~     prior to initiation of cardiopulmonary bypass in patients undergoing coronary bypass~     surgery.~      The goal of this project is to evaluate the tissue levels of HIF-1, VEGF and angiostatin in~     diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (CABG).~   "
125410|NCT01413009|"~     The main goal of the proposed Robert Wood Johnson Foundation's Interdisciplinary Nursing~     Quality Research Initiative (RWJF INQRI) project is to implement, analyze, and disseminate~     an evidence-based, nurse-led, inter-professional, multi-component program focused on~     improving the care and outcomes of critically ill adults.~   "
125411|NCT01412996|"~     This study aimed to compare the short term outcomes between SALC and conventional~     laparoscopic cholecystectomy (CLC).~   "
125373|NCT01414608|"~     This randomized phase III trial studies how well giving cisplatin and radiation therapy~     together with or without carboplatin and paclitaxel works in treating patients with locally~     advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. External radiation therapy uses high-energy x rays~     to kill tumor cells. Internal radiation uses radioactive material placed directly into or~     near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external~     and internal radiation therapy together with carboplatin and paclitaxel kills more tumor~     cells.~   "
125374|NCT01414595|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies tissue samples from patients with non-small cell lung~     cancer.~   "
125375|NCT01414582|"~     This study aims to test whether repeated sessions of tDCS result in long-lasting~     improvements in motor function in patients with chronic stroke.~   "
125376|NCT01414569|"~     The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective~     as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.~   "
125377|NCT01414556|"~     Investigation of GIP effects at fasting and hypoglycemia~   "
125378|NCT01414543|"~     The objective of the proposed research is to gain a detailed understanding and account of~     psychologists' experience of client violence in clinical practice. The emphasis is upon a~     detailed understanding of how psychologists perceive and understand their experience of~     client violence and its impact upon their identity as clinicians and as individuals.~   "
125379|NCT01414530|"~     Muscle or joint pain is one of the most common symptoms during menopausal transition. As~     this could be severe enough to affect social and daily life and to reduce quality of life,~     attentions should be paid about this.~      Although understanding of muscle or joint pain related to menopause is still insufficient,~     estrogen can play an important role. Previous studies have shown that estrogen protects~     cartilage in both animals and humans.~      However, perimenopause is different from postmenopause, in the point that estrogen is still~     secreted with a great fluctuation.~      Until now, no study has been performed to evaluate the effects of oral contraceptive on~     muscle or joint pain in women during menopausal transition. Moreover, since menopausal~     symptoms vary according to ethnicity and culture, a study in Korean population is necessary.~      Therefore, this randomized controlled trial was designed to evaluate the effects of oral~     contraceptive on muscle or joint pain in women during menopausal transition, compared to~     NSAID (non-steroidal anti-inflammatory drug).~   "
125380|NCT01414517|"~     The study will consist of pair of double-blind placebo-controlled trials of dietary~     supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with~     prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to~     undergo pelvic radiotherapy with intent to cure.~   "
125381|NCT01414504|"~     Recently, controversy has emerged regarding the role of the 23vPPV in infants due to~     potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat~     vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated~     protective efficacy against acute lower respiratory tract infection, the investigators feel~     it is a matter of urgency to determine if 23vPPV administration provides elevated antibody~     concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV~     in infants.~      Following consent and eligibility assessment, a baseline blood sample and nose swab will be~     taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose~     swab will be collected 28 days later. The investigators will also collect data on incidence~     of ALRI in all study participants by medical record review.~   "
125382|NCT01414478|"~     The purpose of our study is to determine if the incidence of emesis can be lowered with the~     addition of a high protein drink during labor. Emesis and nausea are the leading causes of~     parturient dissatisfaction, results in a delay of returning to normal, daily living and can~     hugely impact the mother's postpartum experience. To date, no studies have been done on the~     relationship of protein intake during labor and incidence of emesis. To the best of our~     knowledge, the use of a high protein drink during labor has not been evaluated in the~     literature.~   "
125383|NCT01414465|"~     Orlistat is a popular drug approved for long-term use which produces weight loss by~     inhibiting triglycerides, main components of fats in the diet and reducing dietary fat~     absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not~     been described yet. The FA composition of RBCs, plasma and platelets can be used to monitor~     of many pathological processes. This study presents alteration of FA composition in RBCM and~     phospholipids, triglycerides and cholesteryl esters from plasma of health obese female~     volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.~   "
125384|NCT01414452|"~     There is experimental evidence that low levels of adiponectin are associated with more~     reperfusion injury. In addition experimental studies have demonstrated that endothelial~     progenitor cells may have a favorable effect on remodeling, mainly through stimulation of~     neo-revascularisation. Clinical data on these issues are lacking. This clinical project~     studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles~     in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a~     population of 250 infarction patients treated with primary PCI. If the role of these factors~     could be confirmed in this clinical setting, those factors might represent a new target for~     therapeutic interventions in AMI patients.~   "
125385|NCT01414439|"~     This study will examine the efficacy of group therapy utilizing the Existential Approach in~     heart failure patients when compared to a control group of patients who are waiting for the~     same group treatment. This comparison will be achieved by measuring changes in the variables~     studied namely, the levels of psychological distress and levels of psycho-social adjustment.~   "
125386|NCT01414426|"~     This randomized phase II trial studies how well vandetanib works in preventing head and neck~     cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of~     certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from~     forming in patients with premalignant lesions~   "
125387|NCT01414413|"~     Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence~     countries, the majority of people with HIV infection still initiate treatment at an advanced~     stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV~     diagnosis is, therefore, necessary for both individual and public health benefit and is~     being strongly promoted as international and national policy in Malawi. However timely HIV~     diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the~     relatively high proportion of individuals who defer treatment-seeking for months or years~     following diagnosis of HIV.~      Here the researchers investigate the extent to which home assessment and initiation of ART~     adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry~     to, adherence with, and retention in HIV care as the outcome of interest.~   "
125388|NCT01414400|"~     The aim of this study is to prospectively evaluate the frequency of bacteremia after~     ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the~     frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.~   "
125389|NCT01414387|"~     Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment~     for narrowing of the carotid arteries in patients at high risk for open surgery. Special~     devices are used to protect the brain from particles(emboli) that may break off when the~     narrowing or blockage is cleared during the angioplasty and stenting procedure. Although~     filters are most frequently used, protection systems consisting of balloons and flow~     reversal are also available for cerebral embolic protection. However, there is little~     information about the effectiveness of filters compared with balloons and flow reversal for~     prevention of embolization during CAS. The aim of our study is to address this major~     problem. Our study was designed to answer two specific questions: First, the study will~     investigate whether balloon-based protection systems are more effective than filters in~     reducing the amount of particles that break off and travel to the brain during CAS. For this~     purpose two imaging techniques will be used: magnetic resonance imaging of the brain (MRI),~     and transcranial doppler (detection of microparticles in the small brain vessels using~     ultrasound). Second, it will be investigated whether the use of balloon-based protection~     devices are more effective than filters for prevention of stroke, heart attacks, and death~     after carotid stenting. The results of the study will provide important information to find~     out the best way to protect the brain from plaque fragments that may break off during CAS.~   "
125390|NCT01414374|"~     The study aims to investigate the prevalence of genetic polymorphisms in adults with iron~     deficiency and anemia, and the responses to two different treatments: iron sulphate and a~     composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome~     will be hemoglobin, measured before and after 6 weeks.~   "
125391|NCT01414361|"~     Recent studies have shown that optimal IVUS criteria defining the functional significance~     (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of~     the coronary tree. Herein, the investigators performed this study to validate these results~     and to generalize the IVUS criteria defining functional significance of intermediate~     coronary stenosis in a different location of coronary tree in a larger sample size.~   "
125392|NCT01414348|"~     Successful community participation following acquired brain injury (ABI) continues to be an~     elusive goal for patients, clinicians and researchers. Our pilot work shows that community~     dwelling survivors of ABI can significantly improve performance on self-identified real-~     world performance problems and that they can transfer this learning to improve goals not~     trained in the treatment sessions. We will compare two types of rehabilitation intervention~     using a randomized controlled trial. We will also interview survivors, their significant~     others and clinicians regarding their experiences with each intervention to help us discover~     what works best.~   "
125393|NCT01414335|"~     The purpose of this study is to investigate the effectiveness of a dietary supplement with~     high dosage of amino acids and vitamins in the treatment of acute and chronic infection of~     pharyngeal area known as common cold. T~   "
125394|NCT01414322|"~     Phenotype characterization of shortness of breath of pediatric emergency room patients by~     objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy~     and correlates with overall patient outcomes.~   "
125395|NCT01414309|"~     Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs~     in patients with heart failure (HF). The primary purpose of this study is to document the~     natural progression of moderate to severe CSA in heart failure patients.~   "
125396|NCT01414296|"~     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an~     open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects~     with progressive CMPC that has progressed after prior taxane therapy. Subjects who have~     participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from~     continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.~   "
125397|NCT01414283|"~     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label,~     dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive,~     castration-resistant, metastatic prostate cancer that has progressed after prior taxane~     therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.~   "
125398|NCT01413178|"~     The goal of this clinical research study is to compare Busulfex (busulfan) with or without~     Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in~     patients who will receive an autologous stem cell transplant. The safety of this combination~     therapy will also be studied.~      Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may~     cause cancer cells to die.~   "
125412|NCT01412983|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses developed by Bausch + Lomb.~   "
125413|NCT01412970|"~     The purpose of this study is to evaluate the ability to measure central hemodynamics and~     heart-lung interactions non-invasively by electrical impedance tomography and compare it to~     clinically established hemodynamic monitoring.~   "
125549|NCT01412216|"~     The purpose of this study are twofold:~        1. To understand the effects of physical inactivity (sedentarism) on vascular function,~          insulin resistance and inflammation;~        2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of~          physical inactivity on vascular function and inflammation.~   "
125399|NCT01413152|"~     The main objective of this one year multidisciplinary research is to estimate the frequency~     of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an~     undetectable blood viral load (VL) and a detectable VL in semen.~      Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments~     participating to the research project. To warrant feasibility and diversity of participants~     needed, the centers will be located in Paris and nearby suburbs. The study design is based~     on one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be~     taken in the enrolment centers. Biological and virological analyses will be performed by the~     laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological~     analyses are planned in a subsequent study. Socio-behavioral data will be collected through~     a self-administered questionnaire at day 0 and day 30.~      Schedule: Patients' enrolment, collection of biological samples and questionnaires will last~     10 months (end of first quarter 2012). Biological and virological analyses will be performed~     until the end of the first semester 2012. Quantitative and socio-behavioral data will be~     analyzed during the third quarter 2012. Results will be released at the beginning of year~     2013.~   "
125400|NCT01413139|"~     The objective of this clinical investigation is to evaluate puncture site complication rate~     as well as the short- and long-term (up to 24 months) outcome of treatment by means of~     Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4)~     femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of~     BIOTRONIK and without the use of a closure device.~      The hypothesis is that the primary patency at 12 months is non-inferior to the primary~     patency obtained in the Durability study (72.2%).~   "
125401|NCT01413126|"~     Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study~     was to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic,~     insulinemic and selected gut hormone responses, appetite, and food intake over two~     consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated~     in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no~     peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal.~     Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids~     (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive~     sensations and food intake were assessed after breakfast treatments and a standard lunch~     (75g available carbohydrate).~   "
125402|NCT01413113|"~     This phase I trial is studying the side effects and best dose of iodine I 131 when given~     together with pazopanib hydrochloride in treating patients with recurrent and/or metastatic~     thyroid cancer previously treated with iodine I 131 that cannot be removed by surgery.~     Radioactive drugs, such as iodine I 131, may carry radiation directly to cancer cells and~     not harm normal cells. Pazopanib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving iodine I 131 together with~     pazopanib hydrochloride may be an effective treatment for thyroid cancer.~   "
125403|NCT01413100|"~     This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin~     together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil~     works in treating patients with systemic scleroderma (SSc). Stem cells are collected from~     the patient's blood and stored prior to treatment. To store the stem cells patients are~     given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy~     (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be~     collected and stored. After storage, patients are then given high-dose chemotherapy,~     cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune~     system to prepare for the transplant. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy and~     immunosuppression. After the stem cells have engrafted and have matured enough to support~     the immune system at approximately 2-3 months, patients are given a medication called~     mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or~     reactivation of SSc and is referred to as maintenance therapy.~   "
125404|NCT01413087|"~     This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the~     safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following~     intratumoral administration of BC-819 and intravenously administered gemcitabine.~     Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).~      Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of~     BC-819 administered with intravenous gemcitabine on progression-free survival.~      Secondary Objectives: To compare the effects of intratumoral injection of BC-819~     administered in combination with intravenous gemcitabine vs. intravenous gemcitabine alone~     on:~      Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life,~     Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival~   "
125405|NCT01413074|"~     Primary Objective: The primary objective is to prospectively assess and compare survival in~     subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or~     Hemodialysis (HD) treatment.~      Secondary Objectives: The secondary objectives are to prospectively assess and compare the~     following parameters in subjects receiving PD or HD treatment:~        -  Technique failure~        -  Cause of death~        -  Comorbidity status at baseline and changes throughout the study~        -  Change in residual renal function (RRF)~        -  Dialysis adequacy (i.e., Kt/Vurea)~        -  Change in blood pressure, hemoglobin, and S-phosphate~        -  Change in nutritional status~        -  Occurrence of bacterial and other infections~        -  Hospitalization, including number, duration, and underlying reason(s)~        -  Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)~        -  Quality of life (QOL)~      Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious~     adverse events (SAEs), including abnormal laboratory test findings with clinical~     significance, in subjects receiving PD or HD treatment.~   "
125406|NCT01413061|"~     The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft~     with appropriate rigid internal fixation hardware as an alternative to autograft bone graft~     with rigid fixation in subtalar arthrodesis procedures. The primary objective of this~     clinical trial is to compare the overall fusion rate of the investigational to the control~     treatment. Fusion will be determined by clinical findings, radiographs and computed~     tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.~   "
125415|NCT01414244|"~     Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is estimated to~     affect 20% of the US population. IBS patients have significantly decreased quality of life~     and utilize large amounts of health care resources. IBS patients suffer from chronic~     abdominal pain associated with diarrhea, constipation, and/or bloating. Several recent~     studies have shown that diarrhea-predominant IBS (D-IBS) patients have increased intestinal~     permeability that may lead to chronic gastrointestinal symptoms.~      Previously, it has been well established that deficiencies in glutamine may lead to~     increased membrane permeability and supplementation with glutamine can restore intestinal~     membrane permeability. The investigators hypothesize that oral glutamine supplementation~     will improve the IBS Symptom Severity Scale and restore intestinal membrane permeability in~     diarrhea-predominant IBS patients. The investigators propose to conduct a randomized,~     double-blind, placebo-controlled clinical trial studying glutamine compared to placebo for 8~     weeks in 100 diarrhea-predominant IBS patients. This will lead to the following specific~     aims: Specific Aim 1: To determine if oral glutamine supplementation will improve the IBS~     Symptom Severity Scale in IBS patients. To accomplish this aim, the investigators will~     measure the change in the IBS Symptom Severity Scale following treatment with either oral~     glutamine supplementation or placebo. The primary outcome measure will be an improvement or~     clinically significant response to treatment of ≥50 from the baseline score on the IBS~     Symptom Severity Scale. Specific Aim 2: To determine if oral glutamine supplementation will~     restore intestinal permeability in IBS patients. To accomplish this aim, the investigators~     will measure the change in the intestinal permeability following treatment with either oral~     glutamine supplementation or placebo.~   "
125416|NCT01414231|"~     This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is~     compared to the common German standard arm after randomization in a 9:1 ratio. The~     hypothesis involves primarily dosing and application of AraC for induction. It is expected~     that CR rates and as a consequence also LFS are higher in protocols using higher AraC~     compared to lower doses and that LFS might be superior in the study specific arm compared to~     the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is~     given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two~     hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After~     reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5.~     In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv~     on day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7.~      A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using~     MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly~     diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients~     are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates~     evaluated.~      It is still unclear if two consolidation therapies are needed before allogeneic or~     autologous stem cell transplantation. This question is being addressed in the second part of~     the OSHO study, where patients are randomized to receive either one or two consolidation~     therapies.~      In this study all patients with AML and an age of 18-60 years except M3 are entered~   "
125417|NCT01414218|"~     1. Senior citizens living in the community who participate in a humor seminar will have~          improved health quality of life compared to those not participating in the seminar.~        2. Senior citizens living in the community who participate in a humor seminar will have~          improved general well being compared to those not participating in the seminar~        3. Senior citizens living in the community who participate in a humor seminar will have~          decreased psychological distress compared to those not participating in the seminar~   "
125418|NCT01414205|"~     This open-label, multicenter, randomized study will compare the efficacy, safety and~     pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants~     with previously untreated CLL. Participants will be randomized to receive a maximum of 8~     cycles (28-day cycle) of obinutuzumab (1000 mg intravenous [IV] infusion, on Days 1, 8 and~     15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of~     obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each~     subsequent cycle up to 8 cycles.~   "
125419|NCT01414192|"~     This study is being done to provide valid data on the evolution of a cohort of French~     participants treated with ezetimibe, alone or in combination with a statin, to be used in~     simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk~     factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density~     lipoprotein cholesterol (LDL-C) levels over time will be analyzed.~   "
125420|NCT01414179|"~     Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the~     leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on~     a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy~     lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major~     goal of Public health. The transborder Great Area, localised zone in the middle of Europe~     between the very high cardiovascular risks of the North and the weaker risks of the South,~     constitutes a zone privileged for the action against the cardiovascular diseases. However,~     there to date does not exist any joint action in this geographical area. The Public Research~     centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the~     University of Liege, the Clinical Center of Investigation of the University hospital of~     Nancy and the University hospital of the Saar wish to be linked and mutualiser their means~     available and their complementary competences in order to evaluate and to act on the~     cardiovascular health of the citizens of the Great Area. Over one 3 years period the~     Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the~     level of the Great Area a transborder alliance of prevention and promotion of cardiovascular~     health. This great multicentric transverse investigation and poly-set of themes will make it~     possible to collect relevant data on cardiovascular health of the population of the Great~     area.~      Objective of this biomedical research project: It is about multicentric, transverse a~     Européenne epidemiological study aiming, through biological questionnaires and analyses, to~     collect information on the cardiovascular risk factors within the Great Area.~   "
125421|NCT01414166|"~     The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT)~     combination tablets in a primary prevention population currently not taking or eligible for~     lipid-modifying therapy (LMT); the population will comprise participants with low to~     moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol~     (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or~     mildly elevated triglyceride (TG) levels.~   "
125444|NCT01413815|"~     The aim of the study is to test whether pre-operative oral supplementation with L-arginine~     results in a significant reduction of peri-operative cardiovascular complication rate in~     unselected patients undergoing major abdominal or thoracic (non-cardiac) surgery. The second~     aim of the study is to assess whether pre-operative determination of plasma ADMA levels~     allows to identify patients who are at high risk of experiencing a peri-operative~     complication, and whether this subgroup of patients profits specifically from pre-operative~     L-arginine supplementation.~   "
125422|NCT01414153|"~     The purpose of the study is to determine the safety and efficacy of 4 monthly injections of~     iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet~     Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but~     also has anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. The drug may~     therefore have the ability to achieve better visual outcomes than Lucentis, Avastin or~     Eylea, particularly in those subjects who do not demonstrate a robust response to Lucentis,~     Avastin or Eylea after several monthly injections. Further, the combination of Lucentis,~     Avastin or Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple~     mechanisms that contribute to exudative-AMD-related vision loss, better visual outcomes may~     be possible than with Lucentis, Avastin or Eylea alone.~   "
125423|NCT01414140|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of women who are inserted Mirena for intrauterine~     contraception. The objective of this study is to assess safety and effectiveness of Mirena~     under real-life practice conditions. A total 550 patients will be recruited and followed for~     5 years.~   "
125424|NCT01414114|"~     The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV)~     administration of KAI-4169 in the treatment of secondary hyperparathyroidism (SHPT) in~     hemodialysis subjects with chronic kidney disease-mineral and bone disorder (CKD-MBD).~   "
125425|NCT01414101|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in~     subjects with active rheumatoid arthritis.~   "
125426|NCT01414088|"~     The kidneys have numerous salt and water channels and play a major role in the regulation of~     sodium and water. We do not know how these channels work in certain water and sodium~     accumulating medical conditions.~      The purpose of this study is to identify and measure the activity in the water and sodium~     channels by measuring urine biomarkers/proteins in young healthy subjects.~   "
125427|NCT01414075|"~     The purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of~     anemia in patients with end-stage renal disease who recently started dialysis.~   "
125428|NCT01414062|"~     Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who~     are diagnosed at a similar age and stage. One reason for this disparity may be differences~     in post diagnosis dietary behaviors. In order to reduce this disparity, and to improve~     overall survivorship, culturally appropriate dietary interventions that teach women how to~     eat a diet high in fruits and vegetables and low in saturated fat need to be developed for~     Hispanic breast cancer survivors. The investigators propose to conduct a randomized~     controlled study (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud!~     program on changing dietary behaviors among Hispanic breast cancer survivors who have~     recently completed treatment. The ¡Cocinar para su salud! program is a 12 week course that~     provides hands on education and instruction in nutrition education, meal preparation, and~     food shopping in a group setting. All participants will be followed for a total of 12~     months, have clinical assessments at baseline, 6 months, and 12 months, and monthly~     telephone contacts using motivational interview techniques. The Primary Aims are to~     determine the effect of the dietary intervention (¡Cocinar para su salud! program) vs.~     control (standard written nutrition education materials for cancer survivors) on 1) daily~     servings of fruit/vegetable, and 2) daily servings of fat intake from baseline to 6 months.~     The investigators hypothesize that the dietary intervention will result in a larger increase~     of fruit and vegetable intake and a larger reduction of fat intake, when compared to the~     control group. Secondary Aims are to determine the effect of the dietary intervention vs.~     control on 1) biomarkers of fruit and vegetable intake, molecular biomarkers associated with~     breast cancer risk, and anthropometric measures at 6 and 12 months; 2) fruit/vegetable and~     fat intake at 12 months; 3) mediators of dietary change, including readiness to change,~     outcome expectations, perceived self efficacy, food and nutrition skills, self regulation~     skills, and barriers to adherence; and 4) changes in quality of life and anxiety/depression~     at 6 and 12 months.~   "
125429|NCT01414049|"~     Heart bypass surgery is used to increase blood flow to the heart. This surgery is usually~     done using a heart-lung machine (on-pump surgery) allowing the surgeon to perform the~     procedure on a still heart. However, this heart-lung machine causes an inflammatory response~     and is linked with complications such as heart injury, stroke, brain injury, kidney failure,~     need for blood transfusions, irregular heart rhythms and death. An effective way of~     counteracting the effects of the heart-lung machine is to not use the pump itself, thus~     performing the bypass surgery with a beating heart (off-pump surgery). However, off-pump~     surgery is technically more difficult, possibly associated with a decrease in graft patency.~     The ongoing Coronary Artery Bypass Graft Off or On Pump Revascularization Study (CORONARY),~     is a prospective randomized clinical trial comparing bypass surgery done with and without~     the pump. Worldwide, 4700 patients will be included and followed up for 5 years. The~     proposed research project, The Patency AssessmenT of grafts pErformed iN CORONARY~     (PATENCY-CORONARY), is a prospective clinical trial for the evaluation of patency (or~     openness) of the bypass grafts that will enrol 1200 consecutive CORONARY patients reaching~     their one year follow-up. Patients will undergo a non-invasive scan using X-rays to safely~     and quickly evaluate graft patency. The PATENCY-CORONARY trial will determine if off-pump~     surgery is associated with decreased graft patency at 1-year post-surgery compared to~     on-pump surgery when performed by skilled surgeons in different clinical settings, whether~     decreased graft patency is associated with adverse short and long-term outcomes, and explore~     other risk factors associated with decreased graft patency.~   "
125430|NCT01414036|"~     Cigarette smoking is a highly significant health threat, responsible for more than 430,000~     deaths each year. Low-income persons and racial/ethnic minorities are at particularly high~     risk, smoking at greater rates and having greater tobacco-related morbidity and mortality~     than other persons. Yet poor and minority smokers are less likely to receive advice to stop~     smoking or to use tobacco cessation services. Using non-physician members of the health care~     team as patient navigators to connect low-income and minority smokers to evidence-based~     tobacco treatment services is a promising approach because 1) many primary care providers~     (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2)~     minority patients may be less aware of smoking cessation resources and may have~     misconceptions about tobacco dependence treatments; and 3) as primary care practices are~     redesigned as medical homes, non-physician members of the health care team will increasingly~     be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the~     community, working as paid employees, who are trained to guide patients through the health~     care system to receive services. Information on the efficacy of patient navigation to~     connect vulnerable patients to smoking cessation services is needed.~      The investigators will implement a patient navigation-based intervention in the primary care~     setting to promote engagement of low-income and minority patients in smoking cessation~     treatment. To test our intervention, the investigators will conduct a pilot randomized~     control trial (RCT), randomizing 240 patients to the intervention condition (patient~     navigation) or an enhanced traditional care (ETC) control condition. The investigators will~     perform follow-up at three months following the start of the intervention, with a primary~     outcome of engagement in smoking cessation treatment.~   "
125493|NCT01412957|"~     The purpose of this study is to evaluate the benefit of panitumumab in addition to best~     supportive care compared to best supportive care alone in patients with chemorefractory~     wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.~   "
125494|NCT01412944|"~     The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous~     (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial~     responders to secukinumab.~   "
125431|NCT01414023|"~     This experiment will examine if the use of computerized tasks that train individuals to~     control their attention more effectively will predict individual differences in~     obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out~     self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to~     Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which~     will be administered three times over a two week period. At the third visit, participants~     will also complete an anagram task and repeat the blood draw for BDNF testing. The~     investigators hypothesize that computerized tasks that train individuals to control their~     attention more effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally,~     individuals training in CCT will show increased ability to disengage from unattainable goals~     as assessed by responses to an unsolvable anagram task. Finally, individuals training in CCT~     will show a greater increase in BDNF levels as compared to individuals training in PVT.~   "
125432|NCT01414010|"~     The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes~     Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the~     gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid~     and reproducible alterations in fecal microbiota that will spontaneously reverse in the~     weeks after treatment is discontinued.~   "
125433|NCT01413997|"~     The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure~     (CTMM) -quantifying the functional behavior of perimuscular connective tissues.~   "
125434|NCT01413984|"~     The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma~     (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft,~     Oklahoma. The purpose of the proposed study is to expand previous findings by including a~     comparison group of women that are not receiving treatment but are otherwise eligible, and~     by using outside evaluators to conduct the assessments. Furthermore, this study will extend~     the outcomes measured in previous evaluations by including measures of sleep disturbance,~     posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The~     hypotheses for this study are listed below:~        1. Incarcerated women with substance use disorders and history of trauma enrolled in the~          integrated treatment program (HWR plus BT) will report significantly fewer symptoms on~          measures of posttraumatic stress and associated cognitions, substance use, depression,~          and related symptoms following treatment than those in the comparison group.~        2. Those in the treatment group will improve significantly more than those in the~          comparison group on the symptoms listed above.~   "
125435|NCT01413958|"~     This study will compare the nasal congestion symptom relief of phenylephrine extended~     release tablets and placebo in participants with allergic rhinitis.~   "
125436|NCT01413945|"~     The aim of the current study is to test the hypothesis that patients with IBS may have a~     defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the~     current study is to identify the role and competence of ileocecal valve (ICV) in patients~     with irritable bowel syndrome.~      The primary objective is to measure the pressure of the ileocecal valve in patients with and~     without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air~     insufflation of cecum will be used.~   "
125437|NCT01413932|"~     This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,~     and pharmacokinetics of HT-2157 in healthy normal volunteers~      Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose~     evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in~     patients with major depressive disorder~   "
125438|NCT01413906|"~     The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923~     (XL139) when orally administered on a once daily schedule.~   "
125439|NCT01413893|"~     An extension study of linifanib in subjects with advanced or metastatic solid tumors.~   "
125440|NCT01413867|"~     Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of~     less postoperative pain compared with excisional surgery, however a still relevant~     percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A~     new stapler device has been designed to overcome these drawbacks by modifying the stapled~     sutures and by increasing the space for mucosal resection in the case of the stapler.~      This randomized controlled study was aimed to demonstrate whether the new EEA stapler~     Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03~     Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if~     the modified stapled sutures can ensure better intraoperative hemostasis by measuring the~     number of overstitches required to get perfect hemostasis during the operation.~   "
125441|NCT01413854|"~     The purpose of this study is to determine whether diclofenac is effective in the treatment~     of depressed patients with a recent suicide attempt.~   "
125442|NCT01413841|"~     Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous~     Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have~     tested this. In contrast, oxygen causes coronary artery vasoconstriction in man.~     Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of~     oxygen for patients with acute myocardial infarction (with normal blood saturation. The~     investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for~     stable angina or NSTEMI.~   "
125443|NCT01413828|"~     Most of the published data support the preferential use of an anthracycline-containing~     adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and~     trastuzumab, however, are contraindicated due to the observation of unacceptably high rates~     of cardiotoxicity in a large randomized trial in the metastatic setting. However, in~     neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy~     regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All~     large adjuvant trials have evaluated only the sequential strategy of administering~     anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an~     anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting.~     Given the similar patients characteristics, the investigators hypothesize that trastuzumab~     concurrently with an anthracycline-containing chemotherapy regimen would not increase~     cardiotoxicity but efficacy.~   "
126648|NCT01397838|"~     Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone~     degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to~     evaluate the safety of Pro-bone.~   "
125445|NCT01413802|"~     During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice~     quality) are at risk. Therefore intra operative continuous neuromonitoring could help to~     prevent harm to these nerves. Electromyographic data (EMG values) are collected during~     surgery (1). In the postoperative follow-up period detailed voice analysis is performed (2):~     subjective auditive perceptive evaluation and videostroboscopy. Analysis and comparison of~     (1) and (2) will be performed in order to find out if we can find a predictive correlation~     between the EMG data (1) and the voice quality (2).~   "
125446|NCT01413789|"~     Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and~     hydration?~      For this study 16 volunteers and ten patients with healed full thickness burns will be~     included.~      After a short period of acclimatization four test areas will be determined. For healthy~     volunteers the standard zones are located on the inner forearm, two on each forearm.~      For patients with healed burns the 4 test zones are located on either the healed donor site~     or the healed skin grafted area.~      In each test zone baseline measurements will be taken before application of the~     products.After application of the three silicone gels and the hydrating gel cream the trans~     epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured~     by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage & Khazaka).~   "
125447|NCT01413776|"~     The study will evaluate the effects of a nutrition supplement for pregnant women on birth~     weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified~     food supplement will produce babies with a higher mean birth weight than those who do not.~   "
125448|NCT01413763|"~     The purpose of this study is to determine the potential effect of topically applied 3.75%~     imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is~     the change in the 24-hour supraventricular premature beat count. The secondary endpoint is~     the change in 24-hour supraventricular premature couplet and run counts and atrial~     fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular~     premature beat count, ventricular premature couplet and run counts.~   "
125449|NCT01413750|"~     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel~     together is more effective with or without vorinostat in treating non-small cell lung~     cancer.~   "
125450|NCT01413737|"~     This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery~     for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the~     same hospital (St Olav University Hospital, Trondheim, Norway).~   "
125451|NCT01413724|"~     The study is a national survey of pain and pain management to surgical patients in Norwegian~     Hospitals. Data on pain management are gathered from patient records and data on pain and~     patient satisfaction are gathered as patients' self report.~   "
125452|NCT01413711|"~     The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in~     neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of~     vigabatrin.~   "
125453|NCT01413698|"~     People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients~     suffer from a multitude of pathologies of airways and are often inflicted with chronic~     cough.~      Treatment of cough in these patients consists of many types of expectorants, cough~     suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical~     therapy (PT) is often prescribed as part of the treatment regime.~      The assessment of coughing is currently subjective and based on the symptoms qualitative~     description as expressed by the patient or parent. Quantitative and objective methods for~     cough assessment are not available beyond the investigative laboratory and are unique to the~     specific investigator.~   "
125454|NCT01413685|"~     The purpose is to define if calcineurin activity is a better biological parameter than blood~     concentration for the therapeutic tacrolimus monitoring.~   "
125455|NCT01413672|"~     The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin~     environment will result in reduced peristomal skin irritation.~   "
125456|NCT01413659|"~     The objective of the study is to investigate whether peri-operative symbiotic treatment~     could reduce the risk of postoperative infections in patients undergoing elective colorectal~     surgery. This study was also designed to assess the risk-adjusted incidence and predictors~     of surgical site infections.~   "
125457|NCT01413646|"~     The purpose of this study is to examine the effects of walnut consumption on endothelial~     function and lipid markers in overweight patients with at least one factor of metabolic~     syndrome as compared to the control group.~   "
125458|NCT01413633|"~     The investigators describe a novel technique for GB fundus retraction.~   "
125459|NCT01413620|"~     Burned patients because of their increased oxidative stress have severely depleted vitamin~     E, which is a dietary antioxidant. Oxidative stress is responsible for much of the~     pathophysiology seen in burned patients, which leads to acute and chronic morbidity and~     mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used~     to reverse the oxidative stress of burn injury and, in the process, decrease the secondary~     consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining~     adequate vitamin E status.~   "
125460|NCT01413607|"~     The objective of this study is to assess whether using a different type of suture (barbed~     sutures) during partial nephrectomy results in fewer postoperative complications than with~     traditional sutures (non-barbed). The most common complications are urine leakage and~     bleeding. The investigators believe the barbed suture is less technically difficult to use~     and will allow the surgeon to better repair the hole left in the kidney after the tumor is~     removed.~   "
125461|NCT01413594|"~     A randomized control trial of bimanual training in children with hemiplegia. The protocols~     have been developed at Columbia University to be child friendly and draws upon our~     experience since 1997 with constraint-induced movement therapy in children with cerebral~     palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result~     in improved hand function in children with hemiplegia.~   "
125462|NCT01413581|"~     The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants~     as compared with placebo.~   "
125463|NCT01413568|"~     Determine the safety and tolerability of POL6326 when used as a single mobilization agent.~   "
125464|NCT01413555|"~     False positive blood culture results due to specimen contamination with bacteria inhabiting~     patients' skin is a common problem in emergency departments (EDs) in the United States.~     Contaminated blood cultures lead to patient harm through unnecessary hospitalizations and ED~     visits, delays in surgery, unneeded antibiotics, and unnecessary procedures. The~     investigators have developed a multifaceted quality improvement improvement bundle (The~     Blood Culture QI Program) designed to minimize blood culture contamination in the ED. In~     this study, the investigators will implement the quality improvement bundle in six community~     hospital EDs and evaluate its effectiveness at reducing contamination.~   "
125465|NCT01413542|"~     The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4~     inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people~     receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure~     medicine. Understanding how these drugs interact in healthy people will help us learn their~     potential effects in people who have diabetes.~   "
125466|NCT01413529|"~     HIV infected drug users have greater difficulty adhering to highly active antiretroviral~     therapy compared to non-drug users. As sustained adherence to highly active antiretroviral~     therapy is critical to reducing HIV related morbidity, mortality, and reducing the spread of~     HIV, innovative and potentially sustainable treatment strategies that can optimize the~     durability of adherence enhancing interventions among drug users is urgently needed. The~     goal of this study is to further develop and pilot test a smartphone based intervention~     called HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to~     enhance adherence to HAART among HIV infected drug users.~   "
125467|NCT01413516|"~     This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study~     that aims to examine acceptability and feasibility of varenicline use during an acute~     (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).~   "
125468|NCT01413503|"~     This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG~     for the treatment of patients with metastatic or unresectable pheochromocytoma and related~     tumors.~   "
125469|NCT01413490|"~     Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide.~     Current treatment of hepatitis C infection is only successful in about half of those who are~     eligible. The current treatment aims to boost the host immune system but does not directly~     act on the virus. Many drugs are in various stages of development that target the virus~     directly - their specific mode of action is confirmed by showing the virus is forced to~     adapt in the presence of the drug. As with many viruses, treating with only one specific~     drug would quickly lead to the virus adapting and becoming resistant. We therefore need to~     find new combinations of directly acting drugs. Rimantadine has already been shown in the~     laboratory to target hepatitis C directly. We have designed this study to see if it happens~     in real life as well. If so, we could use rimantadine to help fight hepatitis c more~     effectively.~   "
125470|NCT01413477|"~     Nickel contact dermatitis (eczema) is one of the most common allergic conditions affecting~     the skin. This is a study looking at potentially desensitizing nickel-allergic patients to~     their allergy using anti-inflammatory ointments applied to the skin (arm). Application of~     these ointments (ie. modified Vitamin D) has been shown to increase specific immune cells (T~     regulatory cells), which play a role in preventing immune activation and subsequently~     inflammation. The investigators propose use of topical anti-inflammatory agents~     (corticosteroids, modified Vitamin D, or both) may desensitize patients with nickel allergy.~   "
125471|NCT01413464|"~     Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and~     lung disease and may lead to death if unrecognized or not treated. Risk factors for~     developing clots include surgery, hospitalization and/or being immobile. Up to 10 to 40% of~     people may develop a clot during or after their hospital stay or surgery, and sometimes~     these clots do not cause symptoms. In order to help reduce the risk of developing a clot in~     the legs or lungs, many people undergoing surgery receive a small dose of a blood thinner in~     hospital after their surgery is completed. Although prescription of a low dose blood thinner~     is routine practice after most surgeries, the risk or benefit of blood thinners after kidney~     transplant surgery is still not clear. Given this, many transplant physicians differ in~     prescribing practices of low dose blood thinners after kidney transplant surgery. More~     information is needed about the risk of clotting and bleeding in people after kidney~     transplant surgery so that physicians can become more unified in deciding whether a low dose~     blood thinner would protect patients after kidney transplant without producing harm.~      The REPORT study is designed to examine the risk of clotting in the legs or lungs in people~     after kidney transplant surgery as well as the risk of bleeding. Ultrasounds of the legs~     will be performed at various time points after surgery for up to one year to screen for~     blood clots. People participating in this study will also be screened and monitored for~     bleeding after surgery. Although this study will also examine the prescription practices of~     physicians, no blood thinners will be given or withheld from participants as a result of~     this study. Physicians will prescribe blood thinners as per their usual practice after~     kidney transplant. Overall, the goal of the study is to find out how frequent clotting~     and/or bleeding is after kidney transplant surgery, which will help in making~     recommendations regarding the use of low dose blood thinners in people after their surgery.~      Ultrasound scanning of the legs is a safe test that does not cause physical pain and has no~     risk of causing injury. Participation in this study will provide the benefit of additional~     monitoring with several ultrasound tests after surgery, screening for clots in the legs~     which can cause health risks and even death if unrecognized. If a clot is found, it will be~     treated promptly and according to current medical standards under the care of a specialist.~      In the long term, the results of this study will help improve health care delivery to people~     undergoing kidney transplant with the goal of decreasing potential complications such as~     clotting and/or bleeding. Currently, there are no guidelines available to guide physician's~     in the use of a low dose blood thinner after kidney transplant surgery. This study will help~     determine the risk of clotting or bleeding and help us make recommendations that will reduce~     potential risks and complications for people undergoing kidney transplant in the future.~   "
125472|NCT01413451|"~     Background:~      - Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this~     substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab~     helps the immune system to kill cells that have high levels of mesothelin. However, more~     research is needed to determine how safe and effective amatuximab is for treating tumors~     with high levels of mesothelin.~      Objectives:~      - To assess the safety and effectiveness of amatuximab in treating tumors with high levels~     of mesothelin.~      Eligibility:~      - Individuals at least 18 years of age who have a type of cancer that overexpresses~     mesothelin.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and tumor assessment studies.~        -  Participants will have two intravenous doses of amatuximab several hours apart.~          Researchers will monitor them closely and do frequent blood draws. On the same day and~          also within 48 hours of the second dose, participants will have imaging studies. These~          studies will measure how well the amatuximab is working against the cancer.~        -  Participants will have a third imaging study of the cancer about 1 week after the~          infusions.~        -  Participants will have a followup visit 2 weeks after receiving amatuximab. This visit~          will require blood samples. Four weeks after receiving the drug, researchers will~          review patients symptoms or side effects. This interview can be done in person or by~          phone....~   "
125473|NCT01413438|"~     Background:~      - Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM~     are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most~     GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the~     growth of GBMs. More research is needed to find out whether having surgery before starting~     bevacizumab is more effective than bevacizumab alone.~      Objectives:~      - To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.~      Eligibility:~      - Individuals at least 18 years old whose glioblastoma has come back after treatment.~      Design:~        -  All participants will be screened with a physical exam, medical history, blood tests,~          and imaging studies.~        -  Participants will be divided into two groups. One group will have surgery followed by~          bevacizumab. The other group will have the drug without surgery.~        -  The first group will have surgery as soon as possible and will begin bevacizumab 4~          weeks after surgery. The second group will start the drug as soon as possible.~        -  Both groups will receive the drug as an infusion every 2 weeks. They will be monitored~          with frequent blood tests and imaging studies. The infusions will continue for as long~          as the drug is effective at preventing tumor regrowth.~        -  Participants will be contacted every 4 weeks after they stop taking bevacizumab. They~          will answer followup questions either in person or by telephone.~   "
125474|NCT01413425|"~     Background:~      - Smith-Lemli-Opitz syndrome (SLOS) is a genetic disorder that prevents the body from making~     enough cholesterol. People who have SLOS often need to take extra cholesterol, either in~     food or in supplements, for their bodies to work properly. Cholesterol is very important for~     the brain and nervous system. Therefore SLOS is highly related to autism, mental~     retardation, and other brain and nervous system disorders. Not much is known about how~     people with SLOS handle cholesterol and how taking extra cholesterol helps them. A long-term~     study of people with SLOS will help answer these and other questions.~      Objectives:~      - To study the effects of a high-cholesterol diet on people with Smith-Lemli-Opitz syndrome.~      Eligibility:~      - Individuals of any age who have Smith-Lemli-Opitz syndrome.~      Design:~        -  Participants will have study visits up to two times in the first year and once a year~          every year after that. Each visit will last between 3 and 5 days.~        -  Participants will be screened with a physical exam, medical history, and blood and~          urine tests.~        -  Participants will provide regular blood, urine, stool, saliva, and skin cell samples~          for testing.~        -  Participants will keep track of the foods they eat at home. During the study, they will~          eat a high-cholesterol diet at all times, except for the second study visit (3 to 6~          months after the screening visit). That visit will involve a cholesterol-free diet for~          4 weeks.~        -  Participants will have special cholesterol tests with blood samples at different times~          during the study.~        -  At different study visits, participants will have tests of mental and physical skills~          (including tests for autism). They will answer questions about their diet and food~          habits. They will also have hearing and eye tests, body and bone measurements, and~          imaging studies. Not all of the tests will be done at every study.~        -  Participants will be allowed to leave the study at any time.~   "
125475|NCT01413412|"~     This is a prospective randomized study to compare surgical methods for the repair of large~     abdominal hernia.~   "
125476|NCT01413399|"~     The objective of this study will be to assess the frequency of return of spontaneous~     circulation (ROSC), survival to admission, survival to discharge from the hospital, and~     neurologic function at time of discharge from the hospital among patients experiencing out~     of hospital cardiac arrest randomized to receive either intra-arrest induction of~     therapeutic hypothermia (IATH) or post-arrest therapeutic hypothermia (TH).~      Specific aims~        1. Develop and test methodologies for randomizing out-of-hospital cardiac arrest (OOHCA)~          patients to receive one of two therapeutic hypothermia treatments in the prehospital~          environment.~        2. Randomize patients experiencing OOHCA to receive either IATH or post-arrest TH and~          assess the frequency of ROSC, survival to admission, survival to discharge, and~          neurologic function.~        3. Estimate the most efficacious volume of chilled saline administered during the intra~          arrest period.~        4. Identify barriers and strategies for the successful implementation of this project as a~          multicenter randomized trial.~   "
125477|NCT01413386|"~     Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent~     in their patency rate and safety at the 6 months after stenting.~   "
125478|NCT01413373|"~     Development of three-dimensional craniofacial cephalometric analysis for virtual planning in~     orthognathic surgery.~   "
125479|NCT01413360|"~     The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis~     patients whose serum liver enzymes are elevated more than upper limit.~   "
125480|NCT01413347|"~     The purpose of this study is to devise the method to reduce displacement of a left-sided~     double-lumen tube during patient positioning.~   "
125481|NCT01413334|"~     Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test,~     accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive~     coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific~     ischemia. Recently, with the advance of imaging reconstruction and analysis technique,~     several novel parameters computed from CCTA were suggested to have added value in~     determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of~     transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA~     (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined~     by fractional flow reserve (FFR).~   "
125482|NCT01413321|"~     Hemiparetic gait following acquired brain injury (ABI) is grossly characterized by decreased~     speed of walking, increased stance time on the unaffected side, and decreased stance time on~     the affected side.These abnormalities are associated with a complex pattern of dysfunction~     including muscle weakness, spasticity, impaired sensory-motor control, long-term mechanical~     changes in muscles and joints, and cognitive impairments e.g. attention.\ At this stage of~     our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait~     provide insight about the different components of the complex pattern of dysfunction.~      A novel technique had been introduced in the Motion Laboratory of the Sheba Medical Center~     consisting of an ordinary treadmill that is equipped with a 'mat' of more than 5000~     high-quality capacitive pressure/force sensors. This treadmill developed by ZEBRIS enables~     to analyze gait and roll-off patterns on the treadmill.~      Aims of the study:~        1. To assess variability of data derived from the Zebris treadmill.~        2. To investigate stability of hemiparetic gait.~        3. To evaluate variability and relevant gait parameters taking place during recovery after~          acute ABI.~        4. To compare gait on ground with gait on treadmill.~      Rationale of the study- Basic assumptions of the study:~        1. No significant change in gait parameters is expected in both groups including healthy~          controls and chronic ABI subjects in recurrent examination within one week period.~        2. Subacute ABI patients are found to be within the context of neurorehabilitative~          recovery due to brain plasticity. Therefore a change in gait parameters is expected~          within two consecutive examinations in the chosen time intervals.~        3. All measurements are subject to error which contributes to the variance of outcomes.~      On the grounds of these assumptions:~      A. Two consecutive examinations in both groups including healthy controls and chronic ABI~     subjects are intended to estimate the error in measured values.~      B. Two consecutive examinations in the subacute ABI patient group are intended to estimate~     the contribution of neurorehabilitative recovery due to brain plasticity assessed with this~     unique research instrumentation.~   "
125535|NCT01412411|"~     The purpose of this study has been to understand the prevalence of under nutrition and~     develop effective interventions for improving growth and micronutrient status of infants~     receiving complementary foods.~      In this community based randomized clinical trial, the nutrition education package~     implemented aimed to improve hematological parameters including the micronutrient status and~     to see effect on growth indicators.~   "
125483|NCT01413308|"~     Developed in the early 1970s, Fontan Operation has provided palliative care for patients~     with single ventricle physiology. Single ventricle is a rare subclass of the~     atrioventricular (AV) alignment abnormalities double inlet and common inlet ventricles (and~     rarely, straddling tricuspid valve), in which there is only one ventricular sinus [1]. Most~     patients present with symptoms of congestion , low cardiac output, and deep cyanosis~     immedietly after birth. Untreated, these heart anomalies are highly lethal. Neonatal heart~     transplantation is implacable because of shortage of donors. Fontan operation is a three~     staged palliative procedure: the single ventricle pumping blood to the systemic circulation~     , while blood flows laminarly to the lungs through direct anastomosis of the superior and~     inferior vena cavae (total cavo pulmonary connections), inevitably by-passing the right~     heart .~      This procedure has been shown to immediately correct the mixed venous blood dysfunction,~     providing treatment for the prominent signs of cyanosis.~      Along with its beneficial outcomes, Fontan circulation patients have been documented to have~     a variety of post-operative late complications. Of most substantial, increased systemic~     vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of~     decreased preload and increase afterload [3], and atrial arrhythmias [4].~      With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary~     vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological~     pulsatile flow in normal circulation, the pulmonary vasculature is receiving slow velocity,~     laminar flow [5]. Patients post-Fontan operations have been documented to have~     restrictive-type pulmonary function, but still yet to be correlated with Fontan circulation~     or as a possible result of prior lung tissue injury from the pre/intra-operation high volume~     blood flow. Regardless, Fontan patients are described to have decreased pulmonary function.~      The purpose of this research effort is to document and analyze the pulmonary function of~     those patients post-Fontan operation. It is still unclear as to what the long-term effects~     of Fontan operation are towards the pulmonary vascular bed, leaving us questions about the~     effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.~   "
125484|NCT01413295|"~     The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have~     increased the mean survival of these patients. This outstanding advance is due to the~     extended indications for resection of hepatic metastases and to the use of new~     chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal~     antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is~     curative and the majority of patients are overwhelmed by the illness. The first line of~     treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with~     wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10%~     of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic~     cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A~     randomized phase II trial would be performed, by selecting two groups of patients, one of~     them would be treated with the best supportive treatment and the other with DCs plus the~     best supportive treatment. The aim of the study would be to analyze the outcome after 4~     months of treatment. In patients treated with DCs, IFN-γ spot forming cells and~     proliferative responses would be determined pre and post treatment in lymphocytes stimulated~     with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum~     levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.~   "
125485|NCT01413282|"~     The purpose of this study is to determine whether cardiac CT can improve triage of acute~     chest pain patients in the emergency department.~   "
125486|NCT01413269|"~     Early-stage breast cancer patients treated with breast conservative surgery are enrolled in~     this study if they meet defined criteria. Patients are randomized into two groups:~     conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is~     that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar~     efficacy and toxicity.~   "
125487|NCT01413256|"~     Background:~      Respiratory allergic reaction causes great suffering to millions of people worldwide. One of~     the most known allergen- is the pollen from vegetation, ragweed. Genus Ambrosia Ambrosia~     belonged to the complex ragweed flowers are pollinated by the wind and the plant's male~     flowers produce large quantities of small grains of pollen and airborne over long distances~     and those causes allergic reactions. The plant blooms between June and October, creating a~     second wave after wave of allergy caused by spring blossoms.~      This plant originated in North America has invaded many areas in Europe and in recent years,~     taking over large areas in Israel, Hula Valley and northern Acre Emek Hefer for a pen and~     layers to the south. After ragweed plants are based in particular they spread quickly and~     invade agricultural fields and significantly reduce the crop.~      High allergenic ragweed is a health hazard to humans. Ragweed plant investigated many~     aspects of North America and Europe in recent decades and extensive literature on ambrosia,~     but this is the first time ragweed study focuses on Israel.~      Working hypothesis and aims:~      Goal of this study is to identify the existence and nature of the sensitivity distribution~     of ragweed in Israel.~      Importance of research:~      A. Ragweed allergen testing and comparing the effect of exposure to plants on the~     sensitivity of the allergic Israeli patients~      B. The inclusion of ragweed allergen in the diagnostic and therapeutic panel~   "
125488|NCT01413243|"~     Trichuris suis ova (TSO) is a probiotic treatment based on the hygiene hypothesis, that has~     proven safe and effective in autoimmune inflammatory bowel disease. Clinical trails indicate~     that helminth infections have an immunomodulatory effect in multiple sclerosis as well.~     Investigators hypothesize that TSO® 2500 eggs given oral every 2 weeks for 12 months is -~     due to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple~     sclerosis and clinically isolated syndrome significantly more effective than an oral placebo~     treatment as assed by new T2 lesions in cerebral magnetic resonance imaging and clinical~     examination.~   "
125489|NCT01413230|"~     Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the~     skin, the joints, the nervous system and the kidney and may be life threatening.~      SLE is associated with production of autoantibodies and perturbations in regulatory T cells~     and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).~      Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.~      Immunomodulatory effects of vitamin D supplementation in VITRO was recently described,~     notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and~     CD8+ T cells and the decrease of Th17 cells.~   "
125490|NCT01413217|"~     Which is a better breakfast? Egg or cereal?~   "
125491|NCT01413204|"~     The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy~     in patients with type 2 Diabetes for 24 weeks administration.~   "
125492|NCT01413191|"~     This phase II trial studies how well giving cixutumumab works in treating patients with~     metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them.~   "
125495|NCT01412931|"~     Women are being asked to participate in a research study that is looking for new methods to~     understand and predict premature birth (birth before 37 weeks of pregnancy—full term~     pregnancy is 40 weeks). In this study the investigators will be looking at proteins in~     vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new~     form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and~     stiffness, in order to try to know who will have a preterm birth and who will reach full~     term. The investigators will collect the vaginal fluid samples and perform ultrasounds both~     in the clinic throughout pregnancy in normal women, and from women admitted to the hospital~     because they are in early labor. The investigators will collect the placental tissue after~     the baby is born (this is normally discarded). This study will help us to understand the~     process of preterm birth and the investigators hope that this will eventually allow us to~     develop better methods to treat preterm labor and prevent the birth of premature babies.~   "
125496|NCT01412918|"~     To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if~     there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha~     subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not~     disturbed by tinnitus.~   "
125497|NCT01412905|"~     Objective: To test the accuracy of a referral system for diabetic eye disease conducted by a~     trained screener using a digital camera, a mobile medical unit and a centralized~     image-storing software in underserved, ethnically diverse neighborhoods in San Diego.~      Methods and Research Design: Retinal screening exams were offered at 8 community health~     centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County~     over 18 months. Images were captured with a special digital camera, securely transferred to~     a software system and read independently by a trained technician and retinal specialist. An~     analysis was conducted to evaluate who had severe eye disease and how accurate the reading~     of the technician were compared to the expert ophthalmologist readings.~      The investigators would like to demonstrate that telemedicine retinal screening utilizing a~     mobile medical unit with a trained technician in high-risk, ethnically diverse populations~     can accurately detect positive and negative disease. This may be a model to increase access~     to retinal examination in order to meet current guidelines and can allow more efficient use~     of the retinal specialist to evaluate and treat disease leading to a more cost efficient~     method of care.~   "
125498|NCT01412892|"~     Background:~      Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of~     developing tumors of the central and peripheral nervous system. These include plexiform~     neurofibromas. The conventional treatment of these internal plexiform neurofibromas is~     surgery. This surgery can be possible on a single and limited tumor. On the other hand these~     tumors are often surgically intractable due to their multiplicity and their infiltrating~     characteristics Increased activity of mammalian target of rapamycin(mTOR) protein is seen in~     neurofibromas. mTOR inhibitor rapamycin , or its derivatives such as everolimus may slow or~     stop tumor growth in patients with NF1.~      Objectives:~      Primary objectives To determine whether everolimus has an effect on the volume of surgically~     intractable and life-threatening internal plexiform neurofibromas in patients with~     neurofibromatosis 1.~      Secondary objectives To determine whether everolimus has an effect on the number and the~     volume of cutaneous neurofibromas; to determine whether everolimus modify the signaling~     pathways in cutaneous neurofibromas.~      Eligibility:~      - Adults with neurofibromatosis type 1 with at least one internal plexiform neurofibroma,~     life-threatening or causing significant morbidity through compression of organs. This or~     these internal plexiform neurofibroma(s) should be intractable by surgery.~      Design:~      An open-label, single arm, non-randomized, single stage phase IIa study. Baseline phase:~     Baseline evaluations will be performed within 2 weeks, and up to a maximum of 4 weeks for~     specific exams, before the first dose of study drug.~      Treatment phase/duration of treatment: All patients will be treated with RAD001 10 mg p.o~     daily dose for one year except in case of unacceptable toxicity, death, or discontinuation~     from the study for any other reason.~      Follow-up phase: All patients will have two follow-up visits scheduled at 18 and 24 months~     after the first dose of the study drug to follow for adverse events (AEs) and serious~     adverse events (SAEs) that may have occurred after discontinuation from the study and for~     internal plexiform neurofibromas assessment.~      Radiological review: All Magnetic Resonance Imaging (MRIs) obtained at baseline, during the~     treatment period and the follow-up period will be reviewed by the Neuroradiologist of the~     study.~   "
125499|NCT01412879|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy also work in different ways to kill more cancer cells or stop them from~     growing. It is not yet known whether rituximab is more effective with combination~     chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma~     undergoing peripheral blood stem cell transplantation.~      PURPOSE: This randomized phase II trial studies how well giving rituximab together with~     combination chemotherapy or bendamustine hydrochloride followed by consolidation~     chemotherapy and peripheral blood stem cell transplantation works in treating older patients~     with previously untreated mantle cell lymphoma.~   "
125500|NCT01412866|"~     Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood~     disorders) smoke cigarettes, and most suffer related health consequences. Although combined~     treatment with medication and psychosocial therapy can help people with SMI to quit smoking,~     it is rarely used. Motivational interventions can enhance the use of combined treatment, but~     motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and~     Thresholds investigators have developed an easy-to-use, web-based electronic decision~     support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary~     testing has demonstrated excellent usability and increased engagement in smoking cessation~     treatments.~      One critical issue is the use of personalized health feedback. Motivational interventions~     for smoking cessation for smokers with SMI, including our EDSS, have included personal~     feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette~     smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing~     the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult~     to implement, and largely unavailable in public mental health and primary care clinics.~     Further, research on use of carbon monoxide monitoring in the general population is~     equivocal. Another motivational strategy to personalize the negative health effects of~     smoking is a health checklist with feedback. Health checklists have been shown to be~     effective, are easy to use, have no expense, but have not been assessed separately from~     carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the~     health checklist compared to feedback from the carbon monoxide monitor is an essential next~     step in the development of this tool.~      Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess~     whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to~     higher rates of initiation of smoking cessation treatment than the EDSS with~     health-checklist feedback alone.~      Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and~     health-checklist feedback leads to higher rates of the distal outcomes, days of smoking~     abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback~     alone.~   "
125513|NCT01412697|"~     The investigators implemented a theory-based randomized controlled trial in ten rural~     Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including~     fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or~     control groups. Goal setting, peer leaders, and in-class workshops were intervention~     features. Seventh graders filled out surveys on health behaviors, psycho-social variables,~     and demographic characteristics. The investigators expected schools receiving the~     intervention to report a higher fruit-vegetable intake compared to control schools where~     students received standard health information. Sample (n=1,119) was 48.5% female, 50% White,~     with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in~     intervention schools at immediate post and at 1-year follow-up compared to controls.~   "
125501|NCT01412853|"~     Context:~      Prostate cancer is the most common non-cutaneous cancer and the second most common cause of~     cancer-related deaths in European and North-American men.~      After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is~     often fluctuating and PSA nadir may only be reached after 2 years or more and may remain~     detectable several years after the completion of radiation. Moreover, PSA bounces and blips~     render patients and physicians very anxious about any possibility of a relapse. In this~     context, biomarkers that could predict the response to radiation earlier than PSA for~     patients with prostate cancer appear long overdue.~      Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive~     procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines~     and Citrate within the prostate gland.~      Objectives:~      The investigators are conducting a French prospective study on the Evaluation of the~     Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early~     response of radiation with 3D MR Spectroscopy during the first year after completion of~     radiation and its impact on biochemical control. Therefore, the ERIS trial aims to~     investigate whether or not there could be a correlation between the time course of PSA and~     that of Choline and Citrate.~   "
125502|NCT01412840|"~     Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard~     treatment to yield maximal pain relief, a period during which the patient suffers severe to~     intolerable pain. It would thus be valuable to further evaluate sterile water injection as a~     method for achieving rapid relief for this type of pain.~   "
125503|NCT01412827|"~     There has been a shortage of nuclear isotopes, not only in Canada but around the world. New,~     more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras~     have also shown the ability to use a smaller dose of radioisotope to obtain the images. New~     software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The~     Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired~     a new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The~     investigators will now be looking at the quality of images using less isotope during SPECT~     myocardial perfusion imaging for diagnostic and prognostic purposes.~   "
125504|NCT01412814|"~     This study aimed to discover the biomechanics of gait pattern adaptation in patients after a~     total knee replacement.~      The first hypothesis of the project was that center-of-pressure manipulation at the foot~     during dynamic loading is capable of changing the forces, torques and muscle activation~     patterns of the lower limb.~      The second hypothesis of the project was that patient-specific center-of-pressure~     manipulation at the foot combined with repetitive perturbation training over time will~     improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain,~     quality of life and energy consumption in patients after a total knee replacement.~   "
125505|NCT01412801|"~     The study compared the magnitude of the antibody response and safety of a GBS Trivalent~     Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the~     study investigated the maternal to fetal transfer of antibodies induced by the~     investigational vaccine.~   "
125506|NCT01412788|"~     Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon~     patient's quality of life. Although peri-areolar incision has been widely used in benign~     breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary~     reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision~     approach in BCS for cancer patients has not been established by randomized, controlled~     trials.~      This trial was design to compare the Safety and aesthetic outcomes of breast conserving~     surgery between peri-areolar incision approach and traditional methods.~   "
125507|NCT01412775|"~     The study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term~     group intervention program on the levels of psychological stress and professional exhaustion~     experienced by the nursing staff in a cardiac department.~   "
125508|NCT01412762|"~     The purpose of this study is to learn more about what patients undergoing surgery for~     thyroid cancer expect from their surgery. Your input may help us to better prepare and~     inform patients about their disease and its treatment.~   "
125509|NCT01412749|"~     The goal of this data review research study is to create a registry database using~     information (data) collected from patients who have had Endoscopic Head and Neck Surgery~     (eHNS). Researchers want to use the registry database to learn more about short-term and~     long-term outcomes for patients who have eHNS.~      1.1 Primary Objective: To develop a registry database of patients who have had eHNS.~      1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional~     outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center~     (MDACC).~      1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and~     distant failure and survival following eHNS.~   "
125510|NCT01412736|"~     This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the~     effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma~     exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.~   "
125511|NCT01412723|"~     Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency~     and the leading cause of anemia in the world; this can occur at any age, but preschool~     children are at particular risk of developing it. This condition may cause serious~     repercussions for life, being a public health threat of considerable importance worldwide.~      Food fortification is considered the most effective solution to counter this situation,~     because it can help more people than other solutions. It is going to carry out a community~     trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as~     a dietary supplement in preschool children of Medellin with depleted levels of iron; in~     terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is~     hypothesized that at the end of the study the effect of milk fortified with iron amino acid~     chelate won't be less than the effect of fortified with ferrous sulfate.~      It is hoped that the results may contribute, albeit indirectly, to improve the health status~     of children with depleted levels of iron whom consume iron-fortified products.~   "
125512|NCT01412710|"~     The purpose of the present pilot study is to determine the effect of vitamin D~     supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk~     and in improving blood glucose control in type 2 Diabetes subjects . The investigators are~     working with Hispanics and African Americans living in Miami, Florida.~   "
125514|NCT01412684|"~     Most resectable tumors arising in the body or tail of the pancreas are malignancies or~     premalignancies which are surgically treated with distal pancreatectomy in combination with~     splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is~     necessary to complete an oncologically sound operation. Two techniques for spleen preserving~     distal pancreatectomy have been described, but only a small number of lesions are amenable~     to spleen preserving pancreas surgery because these operation compromise oncologic~     principles. Removal of a normal spleen usually does not cause immediate consequences but can~     make patients vulnerable to life threatening infections. Asplenic patients must be vigilant~     for these infections and antibiotic prophylaxis is recommended anytime a fever occurs.~     Splenectomy results in measurable changes in the cellular components of the blood. If~     thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet~     treatment.~      Some childhood hematologic disorders such as hereditary spherocytosis are successfully~     treated with partial splenectomy. The post-surgical remnant spleen has been shown to be~     viable and functional. Both hematologic and immunologic function of the spleen seems to be~     preserved in most patients. Partial splenectomy has also been successful ly employed to~     treat benign and malignant lesions of the spleen. Unfortunately these indications for~     surgery are rare and so the experience with partial splenectomy is small.~      To date, distal pancreatectomy with partial splenectomy has not been described in the~     medical literature. The investigators have devised a surgical procedure combining distal~     pancreatectomy with partial splenectomy, in principal allowing preservation of splenic~     function without compromise of oncologic principles. This procedure is possible now because~     of new technology which allows for near bloodless transection of solid organs. These~     instruments are routinely used in liver, kidney and pancreas surgery. There are scattered~     reports of successful use of these instruments in splenic transection, but there is no large~     experience to date.~      The study intends to answer the question, is the proposed procedure, distal pancreatectomy~     and partial splenectomy, a viable alternative to the current standard of care, distal~     pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of~     pancreas lesions arising in the body or tail of the pancreas?~   "
125515|NCT01412671|"~     This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for~     renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and~     observational study for patients with unresectable or advanced RCC under real-life practice~     conditions. The objective of this study is to assess safety and effectiveness of Nexavar at~     some limited sites which joined to clinical trial of Nexavar, before available of it in the~     market. The enrollment period is 2 months, and patients who received Nexavar will be~     recruited and followed one year since starting Nexavar administration. The data of this~     study will be integrated into the Nexavar PMS and the data will not be analyzed and reported~     alone.~   "
125516|NCT01412658|"~     Background: A novel milk peptide has been shown in laboratory setting to have natural~     anti-cancer properties and extend lifespan and improve metabolism in animal models. The~     purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine~     whether this novel milk peptide positively influence blood markers, metabolism and improve~     quality of life.~   "
125517|NCT01412645|"~     The aim of this study is to investigate potential metabolic effects of resveratrol in men~     with metabolic syndrome(otherwise healthy).~      The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will~     increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate~     bone-turnover.~   "
125518|NCT01412632|"~     The primary endpoint is to investigate the difference in pain between patients who receive~     deep sedation with spontaneous breathing versus patients who receive general anesthesia.~   "
125519|NCT01412619|"~     Patients after cardiac surgical operations often exhibit neuropsychological complications.~     In particular, the post-operative delirium is associated with a significantly increased~     morbidity and mortality.~      Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery~     was verified as the main cause of this.~      The aim of the study is to demonstrate a correlation between intraoperative low measured~     cerebral oxygen levels and a loss neurological outcome, especially the development of~     postoperative delirium, using non-invasive cerebral oximetry (RSO2).~   "
125520|NCT01412606|"~     Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase~     pregnancy rate in women with unexplained infertility.~   "
125521|NCT01412593|"~     Liver disease is a common medical problem in Saudi Arabia. Early studies indicated that~     around 10% of the Saudi population is either infected with hepatitis B or C. An estimated~     12% of chronic HCV and HBV patients undergoing liver biopsy from Saudi centers have~     cirrhosis. Of these 3-5% would decompensate yearly thereby requiring liver transplantation.~     Based on the most recent national census figures, and a 1-2% prevalence rate of HBV and HCV~     nationwide, an estimated 1,000 patients would require liver transplantation on a yearly~     basis for decompensated cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end~     stage liver disease. Unfortunately less than 100 liver transplantations are performed in~     Saudi Arabia in three centers. Around 100 other patients travel abroad for transplantation~     annually while all other patients progressively deteriorate and eventually die from the~     complications of decompensated liver cirrhosis.~      In addition, even in patients who are listed for liver transplantation, often patients are~     too sick to wait on the transplant list that often takes more than a year and the on-list~     mortality is high. A procedure or an intervention that may help to stabilize liver function~     in order to help patients survive on the transplant list while awaiting liver~     transplantation would be of immense benefit. Examples of such interventions are already~     approved and used in some centers like the MARS system.~   "
125522|NCT01412580|"~     Because of the high returns of schooling in developing countries, policymakers pay a lot of~     attention to increasing school access. But if the mother is deficient in folic acid, brain~     development in utero can biologically constrain children's demand for education. Using a~     more scientifically credible research design than has been used in previous research, the~     investigators examine how reductions in micronutrient deficiency (specifically for folic~     acid, B6, and B12) in utero affect subsequent child schooling attainment in Tanzania. The~     investigators also look at the extent to which parents allocate resources to compensate for~     or to reinforce inequalities in children's cognitive endowments. To execute this strategy,~     the investigators follow up on a Randomized Controlled Trial (RCT) with micronutrient~     supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001~     to 2003.~   "
125533|NCT01412437|"~     The investigators will use different types of brain imaging (MRI) in patients with~     Phenylketonuria (PKU) who are currently not on a strict diet to test the hypothesis that~     there is improvement in brain circuitry and biochemistry after return to diet and/or~     sapropterin dihydrochloride (Kuvan).~   "
125534|NCT01412424|"~     MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable~     medical product octreotide used to treat acromegaly. This study will evaluate the efficacy~     and safety of MYCAPSSA™ treatment in patients with acromegaly.~   "
125548|NCT01412229|"~     This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head~     and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged~     appropriate for non-surgical definitive therapy.~   "
125523|NCT01412567|"~     Prevention of perinatal transmission is essential to decrease the global burden of chronic~     HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to~     the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in~     babies. Some studies have however, shown that vaccine alone may be equally effective. Hence,~     immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention~     of transmission of overt HBV infection to the babies. The primary outcome measure of most of~     the trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood~     specimen positive for hepatitis B surface antigen (HBsAg). However, whether this~     immunoprophylaxis also prevents HBsAg negative HBV infection (occult HBV infection) in~     babies is not known. In the present study the investigators evaluated the efficacy of the~     two regimens; vaccination alone and compared it with vaccination plus HBIG administration at~     birth in preventing transmission of both overt and occult HBV infection to the newborn~     babies.~   "
125524|NCT01412554|"~     The purpose of this study is to identify risk factors for insulin resistance and to~     investigate the influence of insulin sensitivity on development of cardiovascular risk~     markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold~     thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and~     sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20~     years.~   "
125525|NCT01412541|"~     The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of~     the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal~     angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.~   "
125526|NCT01412528|"~     Today a variety of diagnostic tools to detect allergenic agents are available such as skin~     tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin~     prick test is the most commonly used test to identify allergies in patients. By using this~     kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin~     prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds,~     new tools appear with the intention to make future applications even more convenient -for~     both, the patient and the physician. For that purpose the development of the so called~     Easyprick Allergen Test System is under way, consisting of a foil that carries~     ready-to-use, allergen-soaked sponges which can easily be applied to the skin after~     pricking.~      Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. In order to control variability and to achieve consistency~     and reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. The present study aims to~     standardize eight allergen extracts by using this method. Standardized extracts will then be~     applied in the Easyprick Allergen Test System which will be evaluated and compared to the~     conventional prick test in a second study.~        -  Trial with medicinal product~   "
125527|NCT01412515|"~     Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8~     (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR~     inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to~     evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients~     suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion,~     all patients will have at least 10 lesions or more than one limb or 3% of body surface~     affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective~     response to everolimus after 6 months therapy (complete or partial response per ACTG~     criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a~     response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%.~     Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3~     patients responded, 15 patients will be accrued in a second stage.~   "
125528|NCT01412502|"~     This study concerns the nearest relatives of patients who have passed away within 3 days of~     admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2)~     death via limitation and / or cessation of active treatment (LATA) without brain death or~     (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe~     score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary~     objective is to determine the proportion of nearest relatives at risk for post traumatic~     stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare~     this factor between the three above-mentioned groups.~   "
125529|NCT01412489|"~     The purpose of this study is to evaluate the intrauterine adhesion rate after the~     application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints~     were tolerance and side effect and subsequent fertility.~   "
125530|NCT01412476|"~     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the~     relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the~     prevention of the risk of MS are still inconsistent. The purposes of this study are going to~     investigate the relation of coenzyme Q10, antioxidant vitamins concentration with the blood~     lipid levels, the markers of lipid peroxidation (TBARS), antioxidant enzymes activities~     (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers~     (hs-CRP,IL-6 and adiponectin). The investigators will recruit MS patients (case group, n =~     100) and age-gender matched healthy subjects from previous study(n = 105) as a control group~     . The inclusion criteria of MS are according to the Bureau of Health Promotion, Department~     of Health in Taiwan (2007).Hopefully, the results of this study could provide the~     information to what has been know in MS subjects. The investigators expect coenzyme Q10 or~     antioxidant vitamins could be a preventive supplement to reduce the risk of MS.~   "
125531|NCT01412463|"~     The objective of this study is to evaluate the immediate and long-term (up to 12 months)~     safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the~     treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal~     artery) between 40 mm and 180 mm in length.~   "
125532|NCT01412450|"~     This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in~     patients presenting with a narrowing or blocking at the level of the knee artery, which~     leads to a limited walking distance, rest pain or non-healing ulcers.~   "
126685|NCT01397357|"~     The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE~     ISCHEMIC HEART DISEASE as topographical correlation between ischemic territory injury and~     coronary angiography.~   "
125536|NCT01412398|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients in continuous cyclic peritoneal dialysis~     (CCPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to~     assess safety and efficacy of using Fosrenol in clinical practice. This study is also all~     case investigation of which the enrollment period is one year, and all patients in CCPD who~     received Fosrenol for hyperphosphatemia will be recruited and followed one year.~   "
125537|NCT01412385|"~     The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option~     for patients with primary immunodeficiency (PID) diseases.~   "
125538|NCT01412372|"~     The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in~     patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will~     evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma~     cytokines before and after treatment with Lialda.~   "
125539|NCT01412359|"~     The overall purpose of this study is to determine if replacing standard soybean oil based~     fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the~     progression of parenteral nutrition associated cholestasis. It is a compassionate use~     protocol for patients who already have significant cholestasis related to parenteral~     nutrition.~   "
125540|NCT01412346|"~     The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based~     foods and fish on indicators of cardiovascular disease risk at two different levels of salt~     intake.~      The study is a 20-wk randomized controlled crossover trial. The subjects follow a~     salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all~     subjects. After that the subjects are randomly allocated to one of two groups. Group 1~     consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16~     weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups~     receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).~   "
125541|NCT01412333|"~     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy~     and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in participants with~     relapsing multiple sclerosis. Participants will be randomized to receive either in Group A,~     ocrelizumab 600 milligram (mg) intravenously (IV) every 24 weeks plus Rabif placebo~     subcutaneously (SC) 3 times weekly, or, in Group B, Rebif 8.8 microgram (mcg) (Weeks 1 and~     2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) SC 3 times weekly plus~     ocrelizumab placebo IV every 24 weeks. Planned duration of double-blind treatment is 96~     weeks. Participants who complete the 96-week double-blind treatment will have an option to~     enter a single group, active treatment open label extension, providing they fulfill the~     eligibility criteria.~   "
125542|NCT01412320|"~     Purpose of the study is to characterize the potential acute and long-term improvement of~     dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).~      Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a~     double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial~     effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day~     long-term, double blind, placebo-controlled parallel study the chronic effects of dietary~     flavanols on vascular function in 52 patients with ESRD will be evaluated.~   "
125543|NCT01412307|"~     Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation~     failure represents a typical unmet medical need prompting active development and validation~     of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide~     and bendamustine, framing different targets on both tumor and microenvironmental cells of~     HL. These agents, while showing a low risk of overlapping extrahematologic toxicities, may~     hit the proliferation machinery of H-RS cells and/or their progenitors, synergistically~     inhibit tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating~     in the microenvironment to support tumor cell survival.~      A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous~     administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a~     28-day cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and~     immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and~     protracted doses of alkylators induce a decrease in microvascular density of tumor tissues~     and inhibit mobilization and viability of circulating endothelial progenitors.~      The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method~     chooses doses based-on both response and toxicity, and accounts for the trade-off between~     these two outcomes.~   "
125544|NCT01412294|"~     The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for~     gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.~   "
125545|NCT01412281|"~     The purpose of this study is to assess the humoral immune response and safety of the~     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal~     V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and~     elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.~   "
125546|NCT01412268|"~     1. Obesity is a big health problem worldwide.~        2. Mostly obese people have food addiction and bad eating habits.~        3. Bariatric surgery is a good alternative for patients who failed to loose weight with~          other measures like behavioral changes, activities and sports, diet, etc..~        4. The investigators know the changes occurred after surgery in eating habits due to~          restrictive and malabsorptive feature of the surgery performed.~        5. There is no study in the literature to measure these changes.~        6. The investigators will try to detect these kind of behavioral changes by a survey~          before and after surgery.~   "
125547|NCT01412242|"~     Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic~     patients with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities.~     All patients will receive a pre-test clinical probability (PTP) and the determination of~     D-dimer. Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All~     other patients will undergo compression ultrasonography (CUS) of the proximal vein system.~     Patients with negative CUS and either low PTP or negative D-dimer will have the diagnosis~     ruled out, while those with high PTP and positive D-dimer will undergo extensive ultrasound~     investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled~     out will be followed-up prospectively up to three months for documenting the development of~     symptomatic thromboembolic events.~   "
125550|NCT01412203|"~     Childhood obesity is a major public health threat. Physical activity and healthy eating~     contribute to the maintenance of healthy weights. Individually oriented behaviour change~     programs may not be able to overcome the influence of what has been called an obesogenic~     environment. Action Schools! BC (AS! BC) used a socio-ecological approach to enhance~     opportunities for physical activity and healthy eating in elementary schools and created~     systemic change at the provincial level. AS! BC helps elementary schools customize action~     plans, based upon their local context, to contribute to the health and well-being of~     children and the school community. Pilot research showed that AS! BC was an effective and~     feasible model. The provincial dissemination of AS! BC has been launched and partners from~     across many sectors are involved to enhance the sharing of knowledge and increase the~     implementation of the AS! BC model across British Columbia. The dissemination provides an~     unprecedented opportunity for evaluating how changing the school environment can promoted~     healthy weights in children. The dissemination was evaluated using a cluster randomized~     design; 30 elementary schools (n = 1529 consented children) from four (out of five)~     provincial health authorities volunteered to participate.~      The primary goals of the research are:~        1. to determine if the Action Schools! BC (AS! BC) model is an effective approach to~          positively change school environments and health related behaviours of children from~          diverse geographical regions and cultural groups, and~        2. to determine if the supports provided to schools or the community context influence the~          uptake and use of the AS! BC model.~      This research will contribute to the science of obesity prevention and knowledge use as well~     as public health practice.~   "
125551|NCT01412190|"~     The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White~     administered with an injector device on aged skin in the face, hands and décolletage.~   "
125552|NCT01412177|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
125553|NCT01412164|"~     The study aims to further assess the safety, efficacy and the performance of its delivery~     system of FIREHAWK rapamycin-eluting stent up to five years.~   "
125554|NCT01412151|"~     The purpose of this study is to extend findings from the creatine dose-finding study~     (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and~     clinical impact of high dose creatine.~   "
125555|NCT01412138|"~     Human endometrium is a very dynamic tissue characterized by cyclical process of~     proliferation, differentiation and cellular shedding as part of each menstrual cycle. This~     issue suggests the presence of somatic stem cells. Endometriosis is characterized by~     presence of endometrium outside the uterine cavity. The existence of a somatic stem cell~     population in endometrium could explain the incorrect proliferation of these cells, which~     would lead to formation of endometriotic foci.~   "
125556|NCT01412125|"~     Huntington's disease (HD) is a rare, autosomal dominant, progressive neurodegenerative~     disorder typically becoming noticeable in middle age. It is clinically characterized by~     progressive involuntary movements (bradykinesia and hyperkinesia), neuropsychiatric~     disturbances (depression, irritability), and cognitive impairments progressing to dementia.~      The striatum (caudate and putamen) is the primary area of neuronal degeneration in HD.~     Today, there is no validated curative treatment. HD affects approximately 6 000 patients in~     France and more than 30 000 individuals are considered at risk for this disease.~      While the disease gene is discovered and we are capable to do a predictive genetic diagnosis~     for asymptomatic patients, there is no clinical or biological way to predict the age of~     onset or the progressive profile of patients.~      One of the fundamental characteristics of this disease is its extreme variability from one~     patient to other both in terms of their evolution and their onset of action. Thus, this~     inter-individual variability severely limits the genetic counselling and complicating the~     neurological assessment.~      Increasingly, it has been assumed that modifier genes may be the source of this~     inter-individual variability and that their identification could help the understanding and~     prediction of disease progression.~      Given that the mutant protein is ubiquitous, the molecular dysfunction of neurons could be~     found in peripheral cells from the bloodstream and will be more accessible to investigation.~   "
125557|NCT01412099|"~     The purpose of this research study is to evaluate the effectiveness of two methods of~     delivering information about nutrition and physical activity to non-traditional college~     students. Participants will receive either a printed feedback report alone, or the feedback~     report in addition to a series of phone calls from a peer counselor. The peer counselors~     will provide nutrition and physical activity counseling using motivational interviewing~     techniques. Nutrition and physical activity outcomes will be measured for both groups and~     compared.~   "
125558|NCT01412086|"~     This study evaluated the inter- and intra-rater reliability of the GEBA Scale with~     photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment~     (intervention) associated with this study.~   "
125559|NCT01412073|"~     trial of 3 protocols to determine the best one to control blood loss during caesarean~     section~   "
125560|NCT01412060|"~     The objective of this study is to evaluate the efficacy and safety of cariprazine relative~     to placebo in the prevention of relapse of symptoms in patients with schizophrenia.~   "
125561|NCT01412047|"~     How does long term treatment with Soliris affect HAHA in PNH patients?~   "
125562|NCT01412034|"~     The available medications used to treat HoFH are targeted at reducing circulating levels of~     total and LDL-cholesterol. These measures can retard the progression of cardiovascular~     disease, however, they are unlikely to regress existing disease due to years of cholesterol~     accumulation in the vessel walls and therefore cannot adequately reduce the existing risk~     for an ischemic event. HDL has multiple actions that could lead to plaque stabilization and~     regression, such as rapid removal of large quantities of cholesterol from the vasculature,~     improvement in endothelial function, protection against oxidative damage and reduction in~     inflammation. This study will assess the effects of CER-001, a recombinant human Apo-A-1~     based HDL mimetic, on indices of atherosclerotic plaque progression and regression as~     assessed by 3Tesla MRI measurements in patients with HoFH.~   "
125589|NCT01411683|"~     This study aims to compare mandibular overdentures retained either by mini or standard size~     implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and~     oral health-related quality of life. We will also evaluate post surgical discomfort, the~     success rate of prostheses and implants in the long term, denture quality and costs.~   "
125563|NCT01412021|"~     This study of Humira will be conducted to clarify the following with regard to the treatment~     of juvenile idiopathic arthritis affecting multiple joints with this drug:~        -  Unknown adverse drug reactions (especially important adverse drug reactions)~        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  Factors that may affect the safety and effectiveness of Humira~   "
125564|NCT01412008|"~     Since the use of botulinum toxin in treating spasticity has already been proven effective,~     we are now using magnetic resonance imaging to examine the toxin diffusion within muscle~     (post injection) in order to determine the specific toxin dose required for an optimal~     treatment response.~   "
125565|NCT01411995|"~     The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain~     associated with intrauterine device (IUD) insertion. They will be randomized to either~     placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically~     via angio-catheter just before IUD insertion. Anticipated pain scores will be assessed using~     a visual analog scale prior to insertion. Using the same pain scale, patients will again be~     asked at the end of the procedure to rate their pain.~   "
125566|NCT01411982|"~     This study will identify the role of PACAP (pituitary adenylate cyclase-activating~     polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that~     has a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with~     nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize~     that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and~     causes blood platelet activation, which contribute to the increased rate of thromboembolic~     disease in these patients.~      To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients~     with nephrotic syndrome will be studied using patient blood and urine samples.~   "
125567|NCT01411969|"~     The aim of this study is to present new data for a better understanding of the anatomic~     correlation of these two notches.~      This study included 32 nasal cavities (16 individuals) with external nasal dilator strip~     (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol~     spray);~   "
125568|NCT01411956|"~     Researchers have linked media messages such as television programs to multiple problematic~     health behaviors. The narrative style of many television programs—involving a plot,~     recurrent characters, entertaining situations, and familiar settings—makes them compelling~     and likely contributes to the powerful influence these programs can have on behavior.~     However, narrative messages are not frequently utilized for prosocial purposes. In~     particular, health education embedded in a narrative context has been neither commonly~     utilized nor carefully evaluated. Using constructs from two complementary theories of health~     behavior, family physicians in a large metropolitan region have developed a situation comedy~     entitled White Coats that aims to provide quality patient education. The program currently~     airs on a local public access channel. The objective of this project is to evaluate the~     effect of one particular episode of White Coats on patient beliefs regarding hypertension.~   "
125569|NCT01411943|"~     This study examines the relationship among epigenetic alterations and the development and~     persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms,~     anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early~     stage breast cancer. The relationship among inflammatory markers and psychoneurologic~     symptoms will also be explored. It is hypothesized:~        1. Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition~          of genetic alterations. These alterations result in cellular changes and are modified~          over time.~        2. Inflammatory activation and epigenetic alterations are related to the temporal~          development, severity, and persistence of psychoneurologic symptoms.~   "
125570|NCT01411930|"~     Antipsychotic medicines used to treat mental illnesses have been associated with effects on~     blood sugar control. Laboratory studies have shown that certain medications in particular~     may alter how insulin works. One purpose of this study is determine if antipsychotic~     medications have immediate effects on insulin action in individuals who do not have a mental~     disorder, but who have risk factors for diabetes. A second purpose is to demonstrate the~     feasibility of using volunteers without psychiatric disorders, and who do not take~     psychiatric medications, as a means for studying antipsychotic metabolic effects.~   "
125571|NCT01411917|"~     Consenting subjects will be randomized to receive injection of bupivacaine or placebo before~     surgery for ileostomy takedown (injection administered after general anesthesia has been~     administered). Pain and side effects will be assessed periodically after surgery using the~     verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All~     subjects in this study will be given toradol to ensure adequate pain control.~   "
125572|NCT01411904|"~     The purpose of this study is to determine if the magnetic needle, in combination with~     magnetic nanoparticles can accurately identify minimal residual disease in leukemia~     patients.~   "
125573|NCT01411891|"~     Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee~     arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per~     10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030.~     Effective post-operative analgesia is an important component with regards to patient~     satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of~     surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of~     thromboembolic disease in patients undergoing total knee or total hip replacement when~     compared with general anesthesia. Post-operatively, regional anesthesia has been shown to~     reduce pain scores and/or morphine consumption as well as opioid-related adverse effects.~      Epidural catheter or spinal anesthesia has become the standard of care at the University of~     Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still~     occasionally used for patients that would strongly prefer a general anesthetic, those that~     are taking anticoagulation medications or with a coagulopathy, those with previous back~     surgery, and those with certain neurologic conditions such as multiple sclerosis or spina~     bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters~     (FNC) for postoperative analgesia following TKA show no significant difference in pain~     scores, morphine consumption, or post-operative nausea and vomiting. However, epidural~     analgesia has been associated with higher incidence of hypotension and urinary retention.~     FNC's placed for postoperative pain allow patients to ambulate more effectively as there~     should not be much of a lower extremity motor block. Patients with a FNC for postoperative~     analgesia also do not require a urinary catheter which eliminates a common source of~     infection in postoperative patients. FNCs have also demonstrated improved rehabilitation~     times and decreased hospital stays which has led to an increased insertion rate of FNCs for~     postoperative analgesia following TKA at the University of Wisconsin.~      Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and~     5.6% following revision TKA. Infection can be a devastating complication following~     implantation of joint hardware often leading to extended hospitalization/rehabilitation~     stays and return trips to the operating room. The average billed charges for all types of~     revision TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling~     lines are a known infection risk and indwelling lines in the femoral region are known to be~     associated with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al.~     found that 57% of FNCs placed without the use of a chlorhexidine impregnated patch had~     positive bacterial colonization. They also described three cases of transient bacteremia~     secondary to FNCs in the 208 catheters that they analyzed.~      Chlorhexidine impregnated patches also known as biopatches have been shown to reduce the~     incidence of bacterial colonization and infection of various indwelling lines including~     epidurals and central venous catheters. Currently no standard of care exists that requires~     the use of biopatches for FNCs. The investigators propose studying the use of the biopatch~     to reduce the incidence of bacterial colonization of femoral nerve catheters.~      The investigators will study the efficacy of the biopatch at decreasing the rate of~     bacterial colonization of FNCs in TKA patients. The FNCs will be inserted in the standard~     fashion and removed at the end of therapy. Typically the FNC infusion will continue until~     the morning of post-operation day (POD) #1 or 2. The process for FNC insertion first~     involves sterile prep and drape of the femoral region. Full sterile technique will be~     utilized including gown, gloves, and mask. Ultrasound guidance is then commonly utilized to~     identify the femoral nerve. Following patient sedation and skin infiltration with local~     anesthetic, a tuohy needle is inserted adjacent to the femoral nerve. A catheter is then~     threaded through the needle in close proximity to the femoral nerve. Patients will be~     randomized to either no chlorhexidine impregnated patch or to a chlorhexidine impregnated~     patch that will be located at the catheter exit site. On the morning of POD 1 or 2, the FNC~     infusion will be discontinued. Typically, Twenty-four to forty-eight hours after catheter~     insertion, it will be removed in a sterile fashion and the skin surrounding the catheter~     exit site will be swabbed and the distal catheter tip will be sent for culture to determine~     bacterial colonization. In addition, the investigators will interview patients and review~     clinical data to determine signs of infection and/or catheter tip colonization rates.~   "
125574|NCT01411878|"~     This study is comparing the impact of two teen pregnancy prevention interventions, Reducing~     the Risk and Love Note with a non-related training on community building to determine which~     is most effective for which participants in delaying sexual initiation, enhancing use of~     condoms and other forms of birth control, decreasing sexually transmitted diseases and~     decreasing the number of pregnancies. The participants will be 1300 youth between the ages~     of 14 and 19 including those from poor urban settings, those from immigrant and refugee~     families and those from the foster care system. Both girls and boys will be in the study.~     The investigators predict that girls, immigrants and refugees and foster youth will have~     better outcomes when participating in Love Notes, a program focused on healthy relationship~     formation and maintenance as a frame for how to manage the sexual aspect of relationships~     while boys and urban youth will have better outcomes when participating in Reducing the~     Risk. Both groups will have better outcomes than those in the control condition.~   "
125590|NCT01411670|"~     The purpose of this study is to investigate the effects on systemic hemodynamics,~     microcirculation and organ function of human Protein C concentrate in patients with sepsis~     and septic shock.~   "
125776|NCT01409486|"~     The aim of the study is:~      to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen~     storage disease type II), to be implemented in the Newborn screening program among the~     Israeli population.~   "
125575|NCT01411865|"~     Diabetes is a common and serious chronic disease. However, there is a large gap between the~     level of care that people should receive (based on research and guidelines) and the level of~     care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the~     Canadian Diabetes Association has a strategy to improve heart disease screening and~     treatment for people with diabetes. This study will evaluate whether the strategy works. The~     focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to~     help them delivery better care for their diabetic patients. In Ontario, only half of doctors~     received this Toolkit. We will compare the quality of care received by diabetic patients~     whose doctors received this Toolkit versus those who doctors did not.~   "
125576|NCT01411852|"~     Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the~     early treatment of patients with traumatic shock compared to standard fluid resuscitation.~      Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive~     resuscitation will result in the same volume of early crystalloid (normal saline) fluid~     administration compared to standard crystalloid resuscitation. The null hypothesis regarding~     safety is that hypotensive resuscitation will result in the same percent of patients~     surviving to 24 hours after 911 call received at dispatch compared to standard fluid~     resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival~     in the Emergency Department or until hemorrhage control is achieved in the hospital,~     whichever occurs earlier.~   "
125577|NCT01411839|"~     The current HIV treatment adherence project was designed to adapt culturally and then pilot~     test an empirically supported cognitive-behavioral therapy program for adherence and~     symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.~   "
125578|NCT01411826|"~     To evaluate online peer support and colorectal cancer screening behavior among individuals~     who are not currently meeting colorectal cancer screening guidelines. This is a randomized~     controlled trial.~   "
125579|NCT01411813|"~     This study examines the role of anxiety in food intake among patients with AN by measuring~     caloric intake in a standardized, laboratory meal with alprazolam versus a placebo. Patients~     will participate in two test meal sessions, one after receiving alprazolam and one after~     receiving a placebo. Patients will be administered psychological measures of anxiety, mood,~     and eating behavior. Primary outcomes include caloric intake in a laboratory test meal and~     pre-meal anxiety levels.~   "
125580|NCT01411800|"~     The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and~     safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.~   "
125581|NCT01411787|"~     This is a randomized, single-site pilot study incorporating one control group. This research~     involves an exercise group and a non-exercise group (control group).~      The patients who are in the exercise group will be enrolled in the Dallas County Women's~     Adventure Boot Camp. This will require them to undergo exercise training 3 times per week,~     under the direction of an experienced personal trainer in a group setting. All Boot Camp~     personal trainers are trained in basic cardiac life support (CPR) and are trained to watch~     for any signs or symptoms associated with a poor exercise response.~      The investigators hypothesize that randomizing women to a supervised exercise program of~     core conditioning, muscular/circuit training, and short distance running administered during~     neoadjuvant chemotherapy for breast cancer can be performed.~      Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their~     breast cancer. This will be about 4 - 6 months.~   "
125582|NCT01411774|"~     The investigators are conducting a randomized double-blind placebo-controlled study to~     assess the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the~     treatment of pediatric obsessive compulsive disorder. This study represents an innovative~     approach in translating bench research findings into clinical research and testing a new~     approach for optimizing an effective psychotherapy with a safe non-psychotropic medication.~   "
125583|NCT01411761|"~     Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are~     favorable microorganisms that regulate the flora of the gastrointestinal system. In this~     study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and~     duration of phototherapy on very low birth weight infants.~   "
125584|NCT01411748|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida~     colonization. The objective of this study is to evaluate the efficacy of prophylactic S~     boulardii in reducing the candida colonization and infection in very low birth weight~     infants.~   "
125585|NCT01411735|"~     BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure~     and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms~     and therapy.~      METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with~     controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial~     of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen~     consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI;~     Doppler-echocardiography; and vascular ultrasound.~   "
125586|NCT01411722|"~     The study aims to assess 1) the electrical activity of the diaphragm in mechanically~     ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical~     activity of the diaphragm may predict the weaning outcome~   "
125587|NCT01411709|"~     A pilot investigation into the stress relieving properties of Vitano® which will assess the~     following hypotheses~      Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate~     responses to mental stress compared to individuals in the control condition~      Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in~     individuals exposed to Vitano® compared to individuals in the control condition~      Vitano® will have positive effects on cognitive functioning.~      Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to~     individuals in the control condition~      There will be a significant improvement in subjective well-being in individuals taking~     Vitano®.~   "
125588|NCT01411696|"~     This is a retrospective data collection study to evaluate the efficacy, safety, and~     re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following~     informed consent, there were no patient study visits. All data was collected via chart~     review.~   "
125591|NCT01411657|"~     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to~     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in~     diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF~     delivery to the human eye will provide neuroprotection (prevent loss of vision) and~     neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the~     trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be~     carefully followed to evaluate safety and efficacy.~   "
125592|NCT01411644|"~     This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian~     dysfunction (WHO III status).~   "
125593|NCT01411631|"~     There is some evidence that polyphenols can affect cognitive function. Therefore,~     consumption of polyphenols has the potential to prevent cognitive impairment or even enhance~     cognitive performance. The objective of this study is to investigate the effect of~     polyphenol consumption served in the form of Concord Grape Juice (CGJ) on cognitive~     performance and driving performance in Mums.~      The study design will be a repeated measures, double-blind, randomised, placebo controlled,~     crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will~     undergo two 12 week dietary interventions which will entail daily consumption of a 12oz~     serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period~     between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive~     performance and driving performance will be assessed (using the driving simulator at the~     Institute for Transport Studies). CGJ is a common ingredient in commercially available~     products.~      Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged~     40-50. This population generally have hectic and stressful lifestyles and therefore there is~     potential for this population to receive cognitive benefit from polyphenol consumption.~   "
125594|NCT01411618|"~     The daily removal of supragingival dental plaque is a major factor in the prevention of~     caries, gingivitis and periodontitis. Proper control of bacterial plaque is obtained through~     the mechanical removal of the biofilm by the proper use of the toothbrush and floss.~     However, some studies have shown that the mean time of brushing tooth surfaces is less than~     that required to obtain a proper cleaning 1 and only 2-10% of the patients use dental floss~     regularly and effectively 2. In addition, it has been demonstrated that even after education~     and motivation of the patient to the proper use of toothbrush and floss, its compliance is~     reduced with time 3. The result is the persistence of plaque in some areas, particularly on~     the interproximal surfaces of teeth. Many studies have demonstrated the effectiveness and~     usefulness of antiseptic mouthwashes containing active ingredients such as chlorhexidine~     (CHX) and essential oils (EO) to prevent and control the formation of plaque and gingivitis,~     when used in addition to mechanical procedures 4-7. Chlorhexidine is still the gold standard~     for its antimicrobial action and high substantiveness, but side effects, such as~     pigmentation, taste alteration and the formation of supragingival calculus limit its~     continued use 8. Essential oil (EO) mouthwashes have been used for years as an adjunct to~     brushing in addressing oral hygiene. Their effectiveness in controlling plaque and~     gingivitis are well documented in literature 9-14. They kill microorganisms by destroying~     their cell walls and inhibiting their enzymatic activity 15,16. Furthermore, phenolic~     compounds like EOs are known to interfere with the inflammation process 17,18. The~     antibacterial action is particularly effective for the ability of the mouthwash with EOs to~     penetrate the biofilm 19-21. The traditional EO mouthwashes contain ethanol, a chemical used~     to dissolve numerous substances in mouthwashes, including CHX. The concentration of ethanol~     present in the mouthwash with EOs is more than 20%, sufficient to dissolve the EOs but not~     enough to carry out a direct antibacterial effect 22,23. Many aspects against the use of~     alcohol in mouthwashes, such as its effects on the surfaces of composite restorations 24 and~     its possible role in the formation of oropharyngeal cancer are being discussed 25,26.~     Although a direct correlation of the cause and effect between the occurrence of~     oropharyngeal cancer and the use of mouthwashes with alcohol 27, has not demonstrated so~     far, it is considered desirable to eliminate ethanol for use in daily mouthwash, bringing in~     search of new formulations. Recently, an EOs containing mouthwash without alcohol was~     introduced on the European market (Daycare, Curaden, Kriens, and Suisse). To our knowledge,~     to date there are no published data on the effectiveness of this antimicrobial product. The~     rinsing with this mouthwash can cause fewer side effects but, in contrast, it may be less~     effective.~      The aim of this study was to evaluate the inhibitory properties of a new alcohol free EO~     containing mouthwash with respect to the traditional mouthwash containing 21.3% ethanol,~     through a standard 3-days plaque regrowth model.~   "
125595|NCT01411605|"~     Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major~     efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and~     is associated with the development of weight-related comorbid conditions and increased~     morbidity.~      Regular physical activity is an important modality of obesity management. Despite~     controversies, poor exercise tolerance has frequently been reported in youth obesity and the~     cause of this limited exercise tolerance remains unknown. Several factors accompanying~     obesity may interfere with exercise tolerance in obese populations. Respiratory factors,~     such as decreased thoracic compliance, increased airway resistance and breathing at low~     pulmonary volumes are associated with obesity and may impact exercise intolerance in this~     population. Moreover, even in people with otherwise normal lungs, the normal ventilatory~     responses to exercise can become constrained in obesity. A thorough understanding of the~     mechanisms underlying this exercise intolerance remains fundamental in order to favour long~     term adherence to exercise training. This is especially true in youth populations, in which~     the management of overweight and obesity must be undertaken as soon as possible, due to the~     early onset of cardiovascular risk factors.~      The main purpose of this study is to determine early-onset cardio-respiratory mortality~     factors in obese adolescents as well as their relation with exercise intolerance (i.e.~     dyspnea) when compared with age and gender-paired normal-weight volunteers.~   "
125596|NCT01411592|"~     The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic~     RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the~     impact of the adhesive system used an established resin cement with an integrated adhesive~     monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with~     Metal/Zirconia Primer) were compared within the study on a randomized basis.~      The aim of the present randomized study was to evaluate wether the difference in bond~     strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered~     zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome~     of all-ceramic RBFDP with a cantilevered single-retainer design.~   "
125597|NCT01411579|"~     One of the most recent and interesting field of diagnostic imaging is diffusion-weighted MR~     imaging (DW-MRI). Various studies evaluated the application of DW-MRI to diffuse liver~     disease and focal liver lesions providing controversial results, probably due to the~     difficult reproducibility of the apparent diffusion coefficient (ADC) measurements. It is~     conceivable that a wide inter/intra-individual variability actually exists in the apparent~     diffusion coefficient (ADC)-values, and that each apparent diffusion coefficient (ADC)-value~     presents an higher reliability in measuring the temporal changes of water diffusion within~     the same individual (longitudinal-evaluation), than in characterizing tissues between~     different patients (transverse-evaluation). For these reasons, some previous studies~     assessed the application of DW-MRI in predicting the chemotherapy (CHT) outcome in liver~     metastases. The rationale of these studies was the overt biochemical changes shown by the~     neoplastic cells after CHT and the sensitivity of DW-MRI in the identification of such~     changes. The same authors noticed that the metastatic lesions with the lowest ADC-values~     present also the best outcome after CHT. Moreover, these studies suggest that it could be~     possible to assess if each single patient will respond (R) or not (NR) to the CHT through~     liver DW-MRI performed from 3 days to 3 weeks after the beginning of CHT.~   "
125598|NCT01411566|"~     The purpose of this study is to evaluate an integrative therapeutic concept for~     schizophrenic patients with comorbid substance use disorder.~   "
125599|NCT01411553|"~     Null hypothesis: (1) there is no difference in rates of ICU-acquired infection based on~     using disposable or cleaned, reusable ECG leadwires and (2) In cardiac surgical telemetry~     floors, there is no difference in false or nuisance sightings or crisis calls based on using~     disposable or cleaned, reusable ECG leadwires.~   "
125600|NCT01411540|"~     The purpose of this study is to compare a diet containing whole grains versus an energy~     matched diet using refined grains on body composition and metabolism.~   "
125601|NCT01411527|"~     By clinical examinations and withdrawing of blood samples from a large number of healthy~     Danish children, this study will reveal if age of pubertal onset is declining. Furthermore,~     the extensive normative data will provide detailed insight into normal ranges and individual~     changes of anthropometrics and hormone levels in healthy children during childhood and~     adolescence.~   "
128425|NCT01374503|"~     The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor~     ALX-0651 is safe and effective after single or multiple intravenous administrations to~     healthy male volunteers.~   "
125602|NCT01411514|"~     The management of MS-patients requires treatment with immune-modifying or immune-suppressive~     agents to prevent new relapses and progression of disability. Several studies have evaluated~     the effect of steroid treatment on clinical recovery after an acute relapse. An important~     unanswered clinical question is, whether or not an oral tapering dose of corticosteroids~     offers any additional advantage over intravenous methylprednisolone alone in improving~     neurologic recovery as well as safety and tolerability after a relapse.~      This study aims to compare the efficacy, tolerability and safety of tapering doses of oral~     prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery~     from an acute relapse in patients with clinically isolated syndrome (CIS),~     relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive~     multiple sclerosis (SP-MS) with superimposed relapses.~      Patients will be treated during 25 days with de-escaling doses of prednisone or placebo.~      The primary analysis will test whether placebo is equivalent to oral prednisone taper on the~     recovery status as measured by EDSS change from baseline to 3 months after baseline.~   "
125603|NCT01411501|"~     A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25~     has the same effect as lactulose in unaided self-defecation frequency of a week and has~     better effect in symptoms improvement (in press). The object is to evaluate whether~     acupuncture is effective for functional constipation. As an explanatory research, it took~     one single point as its intervention and sham acupuncture as its control group (patients~     were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized~     controlled trial to further evaluate whether acupuncture is more effective than routine~     treatment. Acupuncture prescriptions used in this trial are individually prescribed~     according to syndrome differentiation, which can improve clinical effect. .~   "
125604|NCT01411488|"~     The purpose of the study is to determine the prevalence of anal erosions within a 14 day~     period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal~     management systems (FMS).~      Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal~     management systems in a 14 day period.~      Alternative Hypothesis: One fecal management system is no worse than the second fecal~     management system in the development of anal erosion.~   "
125605|NCT01411475|"~     The LATINA registry aims at assessing a new classification of bifurcation restenosis in the~     prediction of major adverse cardiac events in patients who have previously undergone a~     succesful percutaneous bifurcation intervention.~   "
125606|NCT01411462|"~     VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by~     the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which~     integrates a predilation catheter with electronic intravascular ultrasound capabilities.~   "
125607|NCT01411449|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Primovist for contrast~     enhancement in MRI of liver. The objective of this study is to assess safety, especially in~     relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total~     2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and~     followed 7 days after the injection.~   "
125608|NCT01411436|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Nexavar for unresectable~     hepatocellular carcinoma (HCC). The objective of this study is to assess safety and~     effectiveness of Nexavar under real-life practice conditions. This study is an all case~     investigation of which the enrollment period is 2 or 3 months (dependent on sites) for~     Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with~     Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will~     be recruited and followed one year since starting Nexavar administration.~   "
125609|NCT01411423|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have been administered with Nexavar for~     unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to~     assess safety and effectiveness of Nexavar under real-life practice conditions. This study~     is an all case investigation of which the enrollment period is 15 months, and all patients~     who received Nexavar will be recruited and followed one year since starting Nexavar~     administration.~   "
125610|NCT01411410|"~     This open label Phase 1 study involves treating subjects with advanced cancer with~     BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose~     (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel.~     The trial will involve multiple participating sites from the US. Following determination of~     the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned.~     Finally, 16 patients have been enrolled to treatment (Cohort 3). A new expansion cohort with~     modified dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with~     modified dosing) in which another 20 subjects are planned to be enrolled to treatment.~   "
125611|NCT01411397|"~     Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair~     in elective situations is documented, and many studies have reported beneficial outcomes of~     mesh hernioplasty in emergency situations. Still there is controversy of using such grafts~     in presence of intestinal resection.~   "
125612|NCT01411384|"~     This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF)~     in a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL).~     Furthermore, among the objectives of the study is to reveal correlations between CH and CRF~     and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and~     corneal astigmatism (Astig).~      The study adhered to the tenets of the Declaration of Helsinki and written informed consent~     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),~     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing~     primarily on the conditions of the anterior segment of the eye.~      Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive~     if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited~     for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the~     keratoconus group had to present progressive keratoconus in consecutive corneal~     topographies, changes in refractive power, and deterioration of the visual acuity within a~     period of two years. Exclusion criteria included glaucoma, glaucoma suspicion, and~     intraocular pressure (IOP) lowering drugs administration. Further to glaucoma, exclusion~     criteria included central corneal thickness (CCT) less than 400μm, K-readings more than 60D,~     a history of herpetic keratitis, corneal scarring, severe eye dryness, pregnancy or nursing,~     current corneal infection, or underlying autoimmune disease.~      Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our~     outpatient service formed the control group (CG). Further to keratoconus, and a spherical~     equivalent error above 3D, the same exclusion criteria applied to the control group members,~     as well. All participants wearing contact lenses were instructed to discontinue contact lens~     wear at least a month before measurements.~      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the~     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.~     Upon successful fixation of the patient's eye on a red blinking target, the operator~     activated the device. An air puff was released by a non-contact probe, which scanned the~     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the~     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the~     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal~     state. The system monitors the entire process and measures two pressure values, which are~     determined from the inward and outward applanation processes. The aforementioned measuring~     procedure enables the determination of CH which is related to the viscoelastic structure of~     the corneal tissue, and is calculated as the difference between the two pressure values at~     the two applanation processes, and CRF which is indicative of the overall resistance of the~     cornea and is calculated as a linear function of the two pressures associated with the two~     applanation. In order to ensure accurate results, ORA was done four times for each eye, by~     the same operator. Signals that differ significantly in appearance from the other signals~     from the same eye were deleted.~      The same surgical procedure was applied to all keratoconus patients that included:~     Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application~     of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent~     de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture~     of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2~     drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated~     and aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is~     UV-XTM (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was~     irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of~     3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during~     irradiation, as well, in order to sustain the necessary concentration of the riboflavin.~     Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.~      After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone~     qid and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears.~     Soft therapeutic lens was applied until complete re-epithelialization of the cornea was~     detected. Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th~     month after the operation.~   "
125613|NCT01411371|"~     Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity~     and mortality associated with the other. The investigators hypothesized that restoration of~     normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart~     failure. This study randomizes patients with heart failure and persistent AF to medical~     treatment of AF or catheter ablation to restore sinus rhythm.~   "
125614|NCT01411358|"~     The purpose of this study is to evaluate the antibody response to each of the three~     influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by~     hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly~     subjects in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96).~   "
125676|NCT01410552|"~     ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on~     inappropriate shocks, in a general population implanted for primary or secondary prevention~     with a dual or tri chamber device at one year follow-up~   "
125615|NCT01411345|"~     1. The investigators hypothesize that increasing radiation dose to the functional~          MRI-defined lesion in the prostate bed will result in an improved initial complete~          response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is~          related to long-term outcome biochemically.~        2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor~          regions.~        3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that~          are related to an adverse treatment outcome.~        4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because~          the patients will be aware that the dominant tumor will be targeted with higher~          radiation dose.~   "
125616|NCT01411332|"~     1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to~          the dominant tumor lesion in the prostate as identified by multiparametric MRI will~          increase tumor eradication from the prostate.~        2. Biomarker expression levels differ in the multiparametric MRI defined regions at high~          risk of harboring tumors that determine outcome.~        3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related~          to an adverse treatment outcome.~        4. Quality of life will not differ significantly between the treatment arms.~        5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients~          will be aware that the dominant tumor will be targeted with higher radiation dose.~   "
125617|NCT01411319|"~     The hypotheses of this study are:~        1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to~          the dominant tumor lesion(s) in the prostate as identified by multiparametric~          functional Magnetic Resonance Imaging is safe and feasible.~        2. Biomarker expression levels differ in the functional MRI identified suspicious tumor~          regions and unsuspicious tumor regions. The investigators hypothesize that a~          significant source of variation in biomarker levels is due to tumor heterogeneity and~          that it is molecular abnormalities in the dominant tumor areas that are angiogenic and~          determine outcome.~   "
125618|NCT01411306|"~     Despite medical advances, half of the patients admitted to hospital for recovery from acute~     illness, injury or surgery have swallowing difficulties and those requiring tubes for~     breathing support are at even greater risk. Difficulties with swallowing decrease patients'~     quality of life, prolong their hospital stay, as well as lead to medical complications such~     as pneumonia, malnutrition and death. Presently, there is no screening test for swallowing~     difficulties in patients who have required respiratory support. Screening will allow for~     early detection of swallowing problems which is important to prevent serious complications,~     such as pneumonia. This research will determine the accuracy of a new screening test, the~     Toronto Bedside Swallowing Screening Test (TOR-BSST©) previously tested with stroke~     patients, to predict the presence of swallowing difficulties in patients who have required~     breathing support for longer than 48 hours. The investigators will enroll 100 patients from~     the intensive care medical surgical units at the University Health Network. The findings~     from this research will help identify those patients with swallowing problems earlier than~     it is currently possible. Once identified, at risk patients will be referred to a speech~     language pathologist swallowing expert for more comprehensive testing; thereby, decreasing~     their risk of experiencing serious complications, such as pneumonia, secondary to swallowing~     problems.~   "
125619|NCT01411293|"~     The purpose of this study is to define whether the acute consumption of low-fat milk~     protects against postprandial vascular endothelial dysfunction by reducing oxidative stress~     responses that limit nitric oxide bioavailability to the vascular endothelium. The~     investigators hypothesis is that the consumption of low-fat milk will improve postprandial~     vascular endothelial function in an oxidative stress-dependent manner that allows greater~     nitric oxide (NO) bioavailability. The objectives of this study are to 1) examine~     improvements in postprandial vascular endothelial function in response to low-fat milk~     ingestion, 2) define low-fat milk-mediated improvements in circulating biomarkers of redox~     status, and 3) define the mechanism by which low-fat milk improves NO bioavailability.~     Collectively, the successful completion of these studies is expected to define NO mediated~     activities of low-fat milk that protect against vascular endothelial dysfunction in~     individuals at high risk for developing CVD.~   "
125620|NCT01411280|"~     The purpose of this study is to assess whether methylphenidate is effective in enhancing the~     cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained~     neurological complications on laboratory-based measures of sustained attention, reaction~     time, and executive functions, and indirectly, verbal short-term and long-term memory.~   "
125621|NCT01411267|"~     This is a phase I study of the investigational drug AC220 combined with cytarabine and~     etoposide in patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous~     leukemia (AML).~   "
125622|NCT01411254|"~     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for~     diabetic macular edema.~   "
125623|NCT01411241|"~     The aim of the study is to assess whether the second CYD dengue vaccination could be~     administered concomitantly with the booster vaccination of a pediatric combination vaccine~     (Pentaxim™) during the same day and visit but in 2 different sites of administration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the antibody response against all antigens~          (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster~          dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue~          vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine~          administered concomitantly with placebo.~      Secondary Objectives:~        -  To describe the safety of Pentaxim™ vaccine administered concomitantly with the second~          dose of CYD dengue vaccine, or administered concomitantly with placebo.~        -  To describe the safety of the CYD dengue vaccine in all subjects after each dose.~        -  To describe the antibody response to each dengue virus serotype (post-Dose 2 and~          post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly~          with Pentaxim vaccine or administered alone.~        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and~          post-Dose 3 in all subjects.~   "
125624|NCT01411228|"~     A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in~     pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher~     disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase)~     or PB-06-005 (naïve treatment with taliglucerase alfa).~   "
125625|NCT01411215|"~     This is an open-label, multicenter and observational study in China, which is designed to~     record the data of RA & AS patients within 52 weeks after rheumatologists decided to~     prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible~     subjects agreed to be recruited in the study and can withdraw anytime if they choose so.~      Patients with RA or AS are typically managed by rheumatologists. As this study seeks to~     record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the~     treatment, patients will be recruited from Rheumatic department. Rheumatologist will be~     asked to build up the database for RA & AS patient surveillance prospectively in outpatient~     dept, which benefits for the patient treatment outcomes evaluation and clinical management.~   "
125626|NCT01411202|"~     Patients with cancer may experience problems with their breathing due to a fluid~     accumulation around their lungs called malignant pleural effusion (MPE). This fluid can be~     drained but draining may not stop the fluid from accumulating again. MPE can cause shortness~     of breath during activity and at rest leaving patients feeling as though they cannot catch~     their breath enough to be comfortable. Other symptoms can include pain, cough and weight~     loss.~      One way to stop the fluid from accumulating is to create scar tissue between the lung and~     chest wall so there is no more room for fluid accumulation. This procedure is called~     pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This~     procedure is done by injecting a drug into the space between the lung and chest wall through~     a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally,~     patients are admitted for pleurodesis, mostly because the size of the catheter used to~     inject the medication is very large but also because of the potential complications that can~     happen with these larger chest tubes.~      At our centre, most patients with MPE are managed at home with a smaller sized catheter~     known as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for~     treatment and trained staff come into the home to both drain the MPE and monitor the~     patient. Sometimes, patients experience pleurodesis through use of the Pleurx catheter~     alone.~      Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has~     been our experience with a limited number of patients that it is safe to perform pleurodesis~     using the Pleurx catheter for doxycycline injection in an outpatient setting.~   "
125627|NCT01411189|"~     Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy,~     endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal~     resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric~     spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic~     therapeutic procedures will be evaluated based on the proportion of patients with suppressed~     gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by~     an independent committee.~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration.~   "
125628|NCT01411176|"~     Patients with early gastric cancer, who require therapeutic upper gastrointestinal~     endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection~     (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to~     placebo as anti-peristaltic agent will be verified in a randomized, double-blind,~     parallel-assignment design based on the proportion of patients with suppressed gastric~     peristalsis during the procedures. The degree of gastric peristalsis is assessed by an~     independent committee.~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration in comparison~     with the placebo group.~   "
125629|NCT01411163|"~     The purpose of this clinical trial is to extend the Pre-Crest-X study to further assess the~     long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk~     for Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in~     symptomatic individuals are informative in premanifest individuals over a longer duration.~   "
125630|NCT01411150|"~     The purpose of this clinical trial is to extend the Pre-Crest study (Protocol #~     (NCT00592995) to further assess the long-term safety and tolerability of up to 30 grams~     daily creatine in individuals at-risk for Huntington's Disease (HD) and to assess whether~     biomarkers responsive to creatine in symptomatic individuals are informative in premanifest~     individuals over a longer duration.~   "
125631|NCT01411137|"~     The purpose of this study is to find out how doses of IPX066 required to help people with~     Parkinson's disease compare to those required for carbidopa-levodopa sustained-release~     tablets (also known as Sinemet® CR).~   "
125632|NCT01411124|"~     This is a double-blind, placebo-and active-controlled 3-period crossover study designed to~     assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.~   "
125633|NCT01411111|"~     Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils,~     monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli.~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that~     attenuates the production of leukotrienes, through the blockage of the first committed step~     in the leukotriene pathway, 5 lipoxygenase (5-LO) activation.~      GSK2190915 has been shown to be an in vitro inhibitor of human organic anion transporting~     polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), hence there is a potential for a~     pharmacokinetic drug-drug interaction with OATP1/ B1 substrates such as the anti-lipidemic~     rosuvastatin.~      This study will evaluate the effect of repeat oral dosing of GSK2190915 (30milligram (mg)~     and 100mg) on the steady-state pharmacokinetics (PK) of rosuvastatin (10 mg). In addition,~     the study will evaluate the safety and tolerability of this combination when co-administered~     to healthy, adult volunteers in two cohorts.~   "
125634|NCT01411098|"~     This phase I trial studies the side effects and best dose of radiation therapy when given~     together with cisplatin and etoposide in treating patients with non-small cell lung cancer~     that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor~     cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells~     more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and~     etoposide may kill more tumor cells.~   "
125635|NCT01411085|"~     Note: In June 2013, the study design was changed from a randomized controlled study of~     risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of~     risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to~     read:~        1. To determine whether participants treated with risperidone in combination with~          desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days)~          during the final 8 weeks on these medications as compared to pre-baseline. The primary~          hypothesis is that compared to pre-baseline, participants will demonstrate fewer days~          of drinking (per week), as well as fewer days of heavy drinking (per week) in the final~          eight weeks they are taking risperidone and desipramine, as recorded on the Timeline~          Follow-Back assessment~        2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight~          weeks of treatment with risperidone + desipramine compared to the period before~          baseline~        3. To assess the side effect burden associated with the combination of these two~          medications in participants.~      The original aims of the study were:~      The purpose of this study is to determine whether participants who are treated with~     risperidone in combination with desipramine have less alcohol use (fewer drinking days;~     fewer heavy drinking days) than do participants who are treated with RISP with placebo. The~     primary hypothesis is that compared to treatment with risperidone, participants randomized~     to a combination of risperidone plus desipramine will have fewer days of drinking, as well~     as fewer days of heavy drinking. The study will also compare the effects of risperidone as~     compared to risperidone plus desipramine on participants' symptoms and side effects.~   "
125636|NCT01411072|"~     Chemotherapy is given after curative surgery for pancreas cancer to try to improve cure~     rates. There are two choices of chemotherapy which are currently considered equal~     treatments: gemcitabine or 5-fluorouracil (5FU). This study is trying to determine if one of~     two standard chemotherapies is better than the other depending on whether patients have high~     or low human equilibrative nucleoside transporter 1 (hENT1). hENT1 is a protein that is~     found in varying amounts on pancreas cancers.~   "
125637|NCT01411059|"~     This is an Intervention Development Study (IDS) to quantify the physical demands (using~     biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program~     designed for community-dwelling older adults. Additionally, the IDS will explore the~     adherence and adverse events of participation in the program. Data from the IDS will be used~     to develop evidenced-based yoga programs, which the investigators postulate will be~     associated with fewer musculoskeletal side effects compared to non-evidence based yoga~     programs. The investigators also postulate that evidenced-based tailoring of yoga for~     seniors will enhance adherence and efficacy. The programs developed during this IDS will be~     tested in an expanded, Phase II, Randomized Controlled Trial.~   "
125638|NCT01411046|"~     Development of glucocorticoid (GC)-induced adrenal insufficiency is a serious adverse effect~     of GC treatment. It is today not possible to predict this adverse effect. The project aims~     at investigating a possible individual aspect, which may render subjects more or less~     sensitive to glucocorticoids, and thereby influence development of GC induced adrenal~     insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in~     the GC receptor gene will either have increased or diminished GC sensitivity. This may be~     responsible for differences in development of GC induced adrenal insufficiency.~   "
125639|NCT01411033|"~     The purpose of this study is to evaluate the development and progression of chronic~     complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular~     events) in patients with type 1 diabetes treated from the onset of the disease with~     recommended method of intensive insulin therapy. All patients attended a five-day structured~     training program during first hospitalization and re-education once year during the~     observation. After five years of observation and next - once a year chronic complications~     are assessed. The investigators would like to evaluate also the relationship of the~     management of the disease, knowledge about the treatment and diabetes, insulin resistance~     and inflammatory markers with development and progression of chronic complications.~   "
125640|NCT01411020|"~     The purpose of this study is to determine a effect-site concentration of propofol in~     children 3 to 11 years effective to make a induction of general anesthesia.~   "
125641|NCT01411007|"~     The purpose of this study is to develop a technique to provide feedback of brain activity~     and to use this technique to reduce levels of craving in nicotine dependent smokers. The~     researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI~     uses magnets to take pictures of your brain. Functional MRI measures brain blood flow that~     is related to brain activity. This measure of brain activity can be presented or feedback~     to volunteers.~   "
125642|NCT01410994|"~     The purpose of the project is to study the relationship between post-bariatric surgery~     changes in weight and renal parameters.~   "
125643|NCT01410981|"~     The purpose of this study is to understand if small proteins found on the surface of myeloma~     cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and~     pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule~     inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma.~     A sample from the bone marrow biopsy (a small amount of tissue removed from the body for~     laboratory testing) and aspirate (a small amount of fluid is removed from the body for~     laboratory testing) that had been done before the subject entered this study will be~     provided for research purposes. Based on preliminary data, it is hypothesized that CXCR4,~     CD47, sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that~     Pim kinase inhibitors provide a new agent for the treatment of multiple myeloma.~   "
125644|NCT01410968|"~     The purpose of this study is to provide a safety and feasibility basis for future studies~     addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with~     multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic~     administration of Poly-ICLC (Hiltonol) will induce anti-tumor immunity.~   "
125677|NCT01410539|"~     This study is designed to assess the pathophysiology of ST by studying the main procedural~     and anatomical factors involved in the genesis of ST such as those related to stent and the~     vascular wall, as well as to the individual platelet residual reactivity.~   "
125801|NCT01409161|"~     The goal of this clinical research study is to learn if the combination of all-trans~     retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to~     control APL. The safety of this drug combination will also be studied.~   "
125645|NCT01410955|"~     Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of~     irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main~     cause of diarrhea is one of irinotecan metabolites, SN-38 which is in the liver~     glucuronidated and subsequently expelled into the intestine. Due to the bacterial enzyme~     beta-D-glucuronidase in intestinal lumen it is deconjugated. This form causes direct damage~     of intestinal mucosa associated with malabsorption and the development of diarrhea. It is~     known that probiotic bacteria, reduce activity of intestinal beta-D-glucuronidase and~     therefore these bacteria could be applied in the prevention of diarrhea in patients treated~     by this food supplement. Given their low toxicity, good tolerability, probiotics may be an~     important part of supportive therapy. This is a first study aimed to determine the~     effectiveness of the probiotics in the prophylaxis of irinotecan induced diarrhea due to~     reduction intestinal beta-D-glucuronidase activity.~   "
125646|NCT01410942|"~     The goal of this clinical research study is to learn about the effect of different~     combinations of exercise, supportive counseling, and methylphenidate/placebo for the~     treatment of fatigue in patients with prostate cancer. The safety of this treatment~     combination will also be studied.~      Methylphenidate is a stimulant designed to increase the activity of the central nervous~     system.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     symptom, disease or illness. It is designed to be compared with a study drug to learn if the~     study drug has any real effect.~      The exercise in this study is designed to help improve your physical fitness and energy~     levels.~      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,~     pain, and/or sleep disorders.~   "
125647|NCT01410929|"~     The objective of this post market clinical study is to collect prospective clinical data to~     confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the~     spine caused by multiple myeloma.~   "
125648|NCT01410916|"~     This protocol is designed to collect safety and efficacy data on patients that have been or~     will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic~     in Germany.~   "
125649|NCT01410903|"~     The purpose of this study is to evaluate source data for the survival and the investigation~     of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.~   "
125650|NCT01410890|"~     -  The primary objective of this study is to characterize the pharmacokinetics of~          alglucosidase alfa manufactured at the 4000 L scale in patients who have a confirmed~          diagnosis of Pompe disease.~        -  A secondary objective of this study is to evaluate and explore the relationship between~          anti-rhGAA antibody titers and the pharmacokinetics of alglucosidase alfa.~   "
125651|NCT01410877|"~     It is hypothesized that different inhalation profiles (inhalation flow rate versus time~     curves) result from different forms of patient training. Furthermore, significant~     inter-subject variability in these profiles should exist that can, under some circumstances,~     depend on the design of different inhalation devices; this is because dry powder inhalers~     have different airflow resistances. The investigators also hypothesize that the spread of~     flow rate versus time profiles for inhalation can be collected. Finally, these profiles can~     be analyzed from a group of human subjects and used to define a mean and statistical range~     of inhalation flow rate versus time curves.~      The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy~     volunteers after they have (a) read a typical inhaler package insert and (b) been formally~     trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used~     from this pilot study to (a) show the inter-subject variability in the inhalation profiles~     used by adults inhaling through realistic airflow resistances (like those in inhalers)~     following different types of training (b) show how formal training changes inhalation~     technique and (c) provide a database of typical inspiratory profiles for use and improvement~     of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers~     greatly depends upon the way patients inhale through them, this research will result in a~     database to improve the design and in vitro characterization of inhalers.~   "
125652|NCT01410864|"~     This is a non-randomized, post-approval study to further evaluate the rate of post-operative~     Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive~     DuraSeal Exact Spine Sealant System.~   "
125653|NCT01410851|"~     Pulses have the potential to be positioned as a food for body weight and metabolic control~     based on their composition, effects on rate of digestion and absorption of fat and~     carbohydrates, and effects on satiety. However, the role of individual pulses incorporated~     into a mixed meal on regulation of food intake, satiety and glycaemic control remains~     unclear. Therefore, the objective of our study was to determine the effects of ad libitum~     consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food~     intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.~   "
125654|NCT01410838|"~     This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately~     prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and~     fat regain following a period of moderate, yet clinically significant weight loss.~   "
125655|NCT01410825|"~     The Wiskott-Aldrich Syndrome (WAS) is an inherited disorder that results in defects of the~     blood and bone marrow. It affects boys because the genetic mistake is carried on the X~     chromosome. Normal people have blood cells called platelets that stop bleeding when blood~     vessels are damaged. Boys with WAS have low numbers of platelets that do not function~     correctly. Boys with WAS are thus at risk for severe life-threatening bleeding. A normal~     immune system is made of special blood cells called white blood cells, which protect against~     infection and also fight certain types of cancer. In WAS, these white blood cells don't work~     as well as they should, making these boys very susceptible to infections and to a form of~     blood cancer known as lymphoma. The abnormal white blood cells of patients with WAS also~     cause diseases such as eczema and arthritis. Although WAS can be mild, severe forms need~     treatment as early as possible to prevent life-threatening complications due to bleeding,~     infection and blood cancer.~      Over the past decade, investigators have developed new treatments based on the investigators~     knowledge of the defective gene causing WAS. The investigators can now use genes as a type~     of medicine that will correct the problem in the patient's own bone marrow. The~     investigators call this process gene transfer. The procedure is very similar to a normal~     bone marrow transplant, in that the old marrow is killed off using chemotherapy, but is~     different because the patient's own bone marrow is given back after it is treated by gene~     transfer. This approach can be used even if the patient does not have any matched donors~     available and will avoid problems such as GVHD and rejection. The investigators wish to test~     whether this approach is safe and whether gene transfer will lead to the development of a~     healthy immune and blood system.~   "
125656|NCT01410812|"~     The investigators propose that healthy behaviors such as exercise could be increased through~     the use of tying devices - mechanisms that force a coupling of addictive activities~     (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior~     (exercise).~   "
125657|NCT01410799|"~     The purpose of the study is to evaluate the effect of a naturally occurring hormone, called~     Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body.~     GHRH stimulates the production of growth hormone (GH), which regulates the build up of many~     tissues in the body, including muscles and bones. Many elderly people have low levels of GH.~     The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH~     and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in~     four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass,~     physical performance, and how the body uses sugar.~   "
125658|NCT01410786|"~     The purpose of this prospective clinical data-collection is to document the performance and~     clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and~     Conventional Instrumentation.~   "
125659|NCT01410773|"~     The purpose of this study is to demonstrate that untrained subjects with diabetes can use an~     investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from~     fingerstick and from Alternative Site (AST) Palm .~   "
125660|NCT01410760|"~     The PERFORM study is a pilot study investigating the feasibility and usefulness of~     performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an~     addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients~     recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester~     will be invited to take part. FOXFIRE is a national randomised controlled trial in which~     patients with unresectable liver tumours secondary to colorectal cancer will receive~     treatment with standard chemotherapy alone, or with chemotherapy in combination with an~     internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the~     liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan~     would usually be performed prior to the start of treatment and also three months after the~     commencement of treatment to assess the cancer's response to treatment, particularly whether~     the tumour has changed in size as a result of treatment. Perfusion CT gives the normal~     information on changes in tumour size but also assesses whether the blood flow to the cancer~     has changed, which may allow earlier identification of treatment success compared to normal~     CT scans. All patients consenting to participate in the PERFORM study will undergo four~     perfusion CT scans: one before the treatment starts, and one at the start of each of the~     second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of~     measuring tumour perfusion for data analysis using perfusion CT and to establish if the~     tumour perfusion pattern at baseline or shortly after the start of therapy can predict~     response to radioembolisation or chemotherapy. This research is funded by the National~     Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health~     Services Research Committee.~   "
125661|NCT01410747|"~     To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.~   "
125662|NCT01410734|"~     The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides~     real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as~     identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile~     duct (CBD). Irradiation given to the patient during a classic cholangiography can be~     reduced.~   "
125663|NCT01410721|"~     Up to half of all military service members with combat-related traumatic brain injury (TBI)~     also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with~     cognitive problems in what are called 'executive functions' such as planning actions,~     inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems~     day-to-day. These types of impairments occur more often among veterans with both TBI and~     PTSD than among those with only one of these conditions. The combination of TBI and PTSD in~     veterans has also been linked to problems with anger and violence, which are common~     complaints of veterans seeking mental health services post-deployment and have been shown to~     predict poor treatment outcomes in Iraq and Afghanistan veterans.~      Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment~     problems has been demonstrated, there has been little research into clinical interventions~     designed to reduce the severity of cognitive and affective symptoms in veterans with both~     TBI and PTSD. Therefore, the investigators propose a randomized clinical trial involving a~     cognitive rehabilitation intervention that targets improved executive functioning, with the~     participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group~     and n=50 comparison).~      As part of the study, all participants will receive an iPod touch. Participants will be~     placed into one of the two study groups randomly. Based on which group participants are~     placed in, they will receive one of two different sets of iPod touch apps and programs that~     address and aim to improve different facets of cognitive functioning. Regardless of which~     group, Veterans will be instructed to daily practice iPod touch applications on cognitive~     functioning. Also, family members will be trained as mentors to reinforce use of the~     applications in everyday living environments. Trained facilitators will also travel to~     participants' homes to meet with veterans and family to observe behaviors in the home~     environment, arrive at strategies for applying new skills in their situations, troubleshoot~     any iPod technical problems, and review family mentoring processes.~      The investigators will measure clinical outcomes using a comprehensive array of functional~     and structural methods at baseline and six months. The investigators hypothesize improved~     executive function among those in the experimental group as well as reduced~     irritability/impulsivity and improved social/occupational functioning. The investigators~     further hypothesize that, as a group, veterans participating in the cognitive rehabilitation~     program will show significant changes in neural activity associated with executive functions~     when comparing pre- and post-treatment EEG and fMRI responses.~      Better understanding of the neural circuitry and neurocognitive function underlying~     executive function and associated affective control deficits in veterans with both TBI and~     PTSD, and how they relate to treatment outcome, will allow us to better identify therapeutic~     targets for cognitive rehabilitation. The current proposal aims to explore the relationship~     between brain function and connectivity in selective pathways/circuits, neuropsychological~     functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD.~      This study of the neurobiology and neuropsychology associated with intervention efficacy~     will allow us to identify veterans with both TBI and PTSD who are predisposed to positive~     treatment outcomes. To our knowledge, this will be the first attempt to integrate~     neurobiological and neurocognitive techniques with information about the efficacy of a~     theoretically and empirically driven cognitive rehabilitation intervention in veterans with~     combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of~     clinical intervention efficacy and the identification of therapeutic targets (e.g.~     alteration of function in fronto-limbic circuits) relevant to the military population. Given~     links between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression,~     efforts to rehabilitate cognitive function will be particularly important to ensure that~     current and future veterans adjust successfully when they return home to their families,~     workplaces, and communities.~   "
125664|NCT01410708|"~     This study will examine the anti-tumor activity, safety and tolerability of dasatinib in~     adjuvant breast cancer patients in a pre-surgical setting.~   "
125665|NCT01410695|"~     The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to~     methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid~     arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least~     one biologic drug if patients previously failed methotrexate or to 3. methotrexate in~     combination with any DMARD including biologic drugs.~   "
125666|NCT01410682|"~     Critical care nursing interventions related to oral care can reduce the microorganisms in~     the oropharynx available for translocation to other sites. THis is a randomized, controlled~     and double blinded study performed in a pediatric intensive care unit (PICU) from a~     Brazilian university hospital which objectives were to analyze 0.12% chlorhexidine~     digluconate influence on Gram-negative pathogens colonization of oropharyngeal and tracheal~     secretions of mechanically ventilated children.~   "
125667|NCT01410669|"~     This project is a randomized trial to determine if motivational interviewing (MI) is an~     effective intervention to help women in abusive intimate relationships. The study objective~     is to motivate abused women to identify and achieve their own specific goals that can help~     them address the violence in their lives. This project will be integrated into the setting~     of a busy family planning clinic in the mid-western United States, which serves a largely~     rural population. Intimate partner violence (IPV) is screened using the Women's Experience~     with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger~     Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled,~     randomized to the intervention or to usual care group, and complete the 6-month study~     protocol. All subjects complete a self-administered computer-based questionnaire at the~     initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of~     readiness to change, selected IPV-related health correlates (e.g., depression), and steps~     taken and resources used. The MI intervention is an active listening counseling technique~     aimed at guiding the patient towards identifying feasible, personalized goals and steps she~     can take to increase her self-efficacy and control in the relationship. The trained study~     interviewer will work with participants to identify steps they can safely take and local~     resources to help them meet their goals. The MI protocol consists of a face-to-face~     counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and~     4-months post-intervention to reinforce the intervention and assess the participants' level~     safety. The control group will receive usual care, which includes talking with a Level 3~     Domestic Violence Advocate and receiving a comprehensive list of domestic violence~     resources. Effectiveness of the MI intervention will be determined by increased~     self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated~     tool for use among women with a recent history of domestic abuse; and by a reduction in~     depressive symptoms (CESD-10). The impact of the intervention will be assessed by an~     increase in participants' readiness-to-change, and extent of their involvement in a wide~     variety of self-help and coping activities over the follow-up period. If successful, this~     screening and intervention program will be translated to other clinical settings.~   "
125678|NCT01410526|"~     Protocol Synopsis~      Protocol title: Assessment of peritoneal immune response in patients with severe~     intra-abdominal sepsis managed by laparostomy and VAC~      Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal~     sepsis~      Design: Prospective, single-center study~      Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis~      No. of Subjects: 60 patients divided into two groups, 30 patients with severe~     intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal~     operations (middle line incision>15cm). The study is estimated up to 2 year to enroll~      Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient~     discharged or deceased.~      Endpoints:~        1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal~          sepsis.~        2. To correlate the cytokines levels in the abdominal cavity and the serum plasma.~        3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and~          morbidity.~        4. To compare cytokines results in serum plasma and peritoneal fluid between patients with~          severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.~        5. To assess the microbial load in the abdominal cavity in patients with severe sepsis.~        6. To assess the biofilm formation in VAC polyurethane sponge.~   "
125668|NCT01410656|"~     The primary purpose of the study is to determine the effects of an implementation intention~     intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary~     aims are to (a) compare the effects of a telephone-assisted implementation intention~     intervention against a self-administered implementation intention intervention and a~     standard recommendation group on physical activity behaviour and (b) document the effects of~     these interventions on quality of life (QoL), fatigue, symptom management, and physical~     functioning.~      Hypotheses: Evidence exists that an implementation intention intervention can lead to~     significant improvements in PA levels and that regular PA has been shown to improve QoL,~     fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As~     such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the~     researcher-assisted implementation intention intervention will have higher PA levels at the~     1- and 3-month follow-ups compared to the self-completed implementation intention~     intervention and the standard recommendation group; (2) prostate cancer survivors in the~     researcher-assisted implementation intention intervention will show significant improvements~     in QoL, fatigue levels, symptom management, and physical functioning compared to the~     self-completed implementation intention intervention and the standard recommendation group~     at the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed~     implementation intention intervention will have higher PA levels, and better improvements in~     QoL, fatigue levels, symptom management, and physical functioning compared to the standard~     recommendation group at the 1- and 3-month follow-ups.~   "
125669|NCT01410643|"~     Puberty represents a critical period in terms of metabolic health. Racial differences in~     insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a~     female's health later in life. Further, the peripubertal period is likely the period of~     racial divergence in adiposity noted between European American (EA) and African American~     (AA) girls. Diet is a major modifiable risk factor. The identification of simple,~     cost-effective dietary strategies for prevention and management of metabolic disease and~     excess fat mass accrual during the peripubertal period is a priority. Modification of the~     diet to affect metabolic and endocrine outcomes with and without weight loss during the~     pubertal transition represents a novel approach to the pediatric obesity epidemic.~      It is likely that the two diets used in this project will have different metabolic effects,~     including effects on postprandial glycemia, triglyceride concentration, free fatty acid~     concentration, and satiety. These factors may in turn, affect development of metabolic~     perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role~     of carbohydrates on metabolic outcomes, particularly among children, has received little~     attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for~     disease progression. Development of a diet that reduces insulin secretion and optimizes~     metabolic-endocrine health among peripubertal girls will likely reduce obesity and related~     co-morbidities and future reliance on pharmacologic treatments, even in the absence of~     weight loss. However, in light of the current trends in pediatric obesity, a safe and~     effective regimen that also promotes weight loss is needed for the pediatric population.~      This proposal is significant in that it will shed light on whether diet composition, as a~     part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the~     hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that~     elevated concentrations of insulin and/or reproductive hormones may contribute to the fat~     mass accrual in AA and could elevate risks for development of chronic diseases in adulthood.~     The results of this study will lead to the development of dietary means for the reduction of~     insulin, and thereby to the prevention of both pediatric obesity and type 2 diabetes.~   "
125670|NCT01410630|"~     A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that~     yields better tracking of cancer treatment progress. PET/CT stands for positron emission~     tomography with low dose computed tomography and has been used for many years. 18F-FLT~     PET/CT uses a new tracer, fluorothymidine, which is taken up by cells that are actively~     proliferating or dividing such as cancer cells. We hope to learn whether this tracer is~     superior to the conventional tracer for monitoring treatment of diffuse large B-cell~     lymphoma (DLBCL).~   "
125671|NCT01410617|"~     Coronary artery disease is a major cause of death in patients with renal dysfunction Among~     patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a~     major predictor of in-hospital and remote mortality As little is known about the impact of~     non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary~     surgery we have decided to investigate the effect of prophylactic Hemodialysis on the~     mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with~     the control group~   "
125672|NCT01410604|"~     The purpose of this study is to compare serum concentrations of inflammatory cytokines,~     interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour~     necrosis factor alpha (TNFα), before and after three months treatment with metformin in~     obese adolescents with insulin resistance (IR).~   "
125673|NCT01410591|"~     The purpose of this study is to determine whether transjugular intrahepatic portosystemic~     shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in~     comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of~     variceal bleeding.~   "
125674|NCT01410578|"~     The investigators enrolled 144 subjects admitted to ICUs: 60 patients with systemic~     inflammatory response syndrome (SIRS) and 84 patients with sepsis. Tests for serum sTREM-1,~     PCT, and CRP levels and blood culture were performed on the day of admission and with the~     occurrence of FUO (>38.3ºC) during hospitalization. Based on the results of blood culture,~     the subjects were divided into bacteremia (33 patients) and non-bacteremia groups (51~     patients). Based on 28-day survival, bacteremia patients were also divided into survivor (22~     patients) and non-survivor groups (11 patients). Serum sTREM-1 and PCT levels were~     summarized as medians (interquartile ranges) and CRP levels were presented as means ±~     standard deviations. To explore the early diagnostic value of soluble triggering receptor~     expressed on myeloid cells 1 (sTREM-1), procalcitonin (PCT), and C-reactive protein (CRP)~     serum levels for identification of sepsis and bacteremia and the prognosis among patients~     with a fever of unknown origin (FUO) in the intensive care unit (ICU) and to discuss the~     clinical application of the results.~   "
125675|NCT01410565|"~     This is an international, multicenter, double-blind, placebo-controlled, randomized study.~     All eligible patients entering the open label phase of the study will receive a single~     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral~     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double~     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive~     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo~     cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients~     with histologic evidence of recurrent disease during the study will be treated according to~     current treatment guidelines or local standard of care. Safety and efficacy assessments will~     be performed at 3 month intervals for all randomized patients throughout the study. Patients~     who receive single dose of apaziquone immediately following TURBT and are not eligible for~     randomization will be followed for 3 months by cystoscopic exam and safety assessments.~   "
125679|NCT01410513|"~     Primary Objective:~      - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for~     SAR245409 when administered in combination with rituximab or bendamustine plus rituximab~      Secondary Objectives:~        -  To determine the safety and tolerability of SAR245409 in combination with rituximab or~          bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL)~          Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)~        -  To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when~          used in combination in subjects with iNHL, MCL or CLL~        -  To determine the pharmacodynamic (PD) effects of SAR245409 in combination with~          rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL~        -  To determine the antitumor activity of SAR245409 in combination with rituximab or~          bendamustine plus rituximab in subjects with iNHL, MCL or CLL~   "
125680|NCT01410500|"~     The purpose of this study is to expand upon the safety data for carfilzomib by providing~     expanded access to patients with relapsed and refractory multiple myeloma who are unable to~     enroll in any other ongoing carfilzomib trial.~   "
125681|NCT01410487|"~     Obesity is a medical problem of epidemic proportions and is associated with high mortality.~     Obesity has significant effects on the cardiovascular system, producing structural~     cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis;~     diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased~     aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that~     obesity increases the risk for heart disease independent of other known risk factors such as~     coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea.~     Obesity also causes significant changes in pulmonary function, including a decrease in~     expiratory reserve volume and functional residual capacity and closure of peripheral~     airways. The exact mechanisms for the development of cardiopulmonary disease are not well~     understood - the pathophysiology is complex and likely multifactorial, related to altered~     hemodynamic load, altered metabolic activity, underlying inflammation, and increased cardiac~     output.~      Newer diagnostic modalities available at our institution such as cardiac MRI and pulmonary~     function tests with impulse oscillometry allow us to better evaluate cardiopulmonary~     dysfunction in patients with severe obesity. Cardiac MRI is especially promising as a~     non-invasive imaging modality in obese individuals, providing more reproducible measurements~     of cardiac and vascular anatomy and function relative to echocardiography. Similarly,~     pulmonary function testing with impulse oscillometry is more sensitive for detection of~     abnormalities in the distal airways especially when spirometry is normal, as frequently~     occurs in the severely obese symptomatic patients. The main objective of the proposed study~     is to evaluate the effect of obesity on quality of life and health care utilization and its~     relationship to cardiopulmonary disease in an ethnically diverse, underserved obese~     population by using state-of-the-art diagnostic modalities before and after significant~     (20%) weight loss.~      The investigators propose to perform stress cardiac MRI and pulmonary function testing with~     oscillometry before and after significant surgical weight loss in 150 severely obese~     patients with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity~     Center at Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who~     have cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and~     pulmonary function testing will be approached by the study personnel and offered enrollment.~     Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a~     detailed medical history including the Borg dyspnea scale, physical examination, laboratory~     testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein,~     atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary~     physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS).~     Patients with active smoking history and/or asthma will be identified clinically.~      Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare)~     system. Standard cardiovascular techniques will be used for the assessment of myocardial and~     vascular structure and function, including T1-weighted, T2-weighted, late gadolinium~     enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress~     MRI will be performed for evaluation of underlying coronary artery or microvascular disease.~   "
125682|NCT01410474|"~     This study will evaluate the immunogenicity and safety of a single injection of Novartis~     Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.~   "
125683|NCT01410461|"~     Study aims to: (1) evaluate the role of morphological and physiological characteristics of~     the pelvic floor, pain-related psychological and -psychophysical variables in prediction of~     the success of myofascial physical therapy (MPT) for the treatment of painful bladder~     syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory~     testing in the genital area, perineal ultrasound examination for the evaluation of the~     length of the levator muscles before MPT and following 10 consecutive sessions of MPT.~      Improvement in clinical symptoms will be assessed and evaluated for correlations with~     psychophysical examinations.~   "
125684|NCT01410448|"~     The purpose of this study is to evaluate whether delayed (i.e. 28 ± 4 days post-transplant)~     administration of everolimus after transplantation reduces the risk of wound healing~     complications in comparison with immediate administration in de novo renal transplant~     patients (proportion of patients without wound/surgical complications related to initial~     transplant surgery) between randomization and 3 months after transplantation~   "
125685|NCT01410435|"~     Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks~     studies there is a need to follow-up on long term safety and efficacy of any maintenance~     iron therapy.~      This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron~     isomaltoside 1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000~     (Monofer®) and its ability to maintain stable haemoglobin in IBD subjects with Iron~     Deficiency Anaemia (IDA).~   "
125686|NCT01410422|"~     Metabolomics is a large-scale approach to monitoring the compounds involved in cellular~     processes. It may reflect changes in biological function. Collection of exhaled breath is a~     newly developed, noninvasive method that may allow clinicians and researchers to assess~     biochemical profiles in the airway. This study is conducted for the metabolomic analysis of~     the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and~     bronchiectasis.~   "
125687|NCT01410409|"~     The purpose of this study is to test whether surgical insertion of total knee replacement~     provides further improvement in quality of life, pain and function in addition to an~     algorithm for systematic non-surgical treatment consisting of corrective insoles,~     neuromuscular training, weight loss, patient education and pharmacological treatment with~     paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the~     MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).~      The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment~     results in a greater increase in quality of life and functional capacity and greater~     reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is~     follow-up 12months after the start of the treatment.~      See statistical analysis plan available under Links for further description of the study.~   "
125688|NCT01410396|"~     The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac~     monitoring for detection of atrial fibrillation in patients with history of stroke of known~     cause.~   "
125689|NCT01410383|"~     Eprotirome is a liver selective thyroid hormone that can reduce several independent risk~     factors for cardiovascular disease, while an euthyroid state is preserved in the~     extrahepatic tissue.~      The purpose of this Phase III study is to assess the long-term efficacy and safety of~     Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal~     standard of care.~   "
125690|NCT01410370|"~     The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar~     infusion combined with radiotherapy for treatment of brain metastases.~   "
125691|NCT01410357|"~     This project tests a model for improving illness self-management among persons who have both~     serious mental illness and diabetes and will be performed within a primary care setting at a~     safety net hospital system. The information gained from the randomized trial will be~     supplemented with reports from participants about their experiences of trying to improve~     illness self-management. Improvements in self-management should result in a reduction of~     psychiatric symptoms and improvements in functioning and physical health.~   "
125692|NCT01410344|"~     The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT~     for patients with chemotherapy-sensitive hematological malignancies and coincident~     HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as~     an indicator of the safety of transplant in this patient population. Correlative assays will~     focus upon the incidence of infectious complications in this patient population, the~     evolution of HIV infection and immunological reconstitution. Where feasible (and when this~     can be accomplished without compromise of either the donor quality or the timeliness of~     transplantation), an attempt will be made to identify donors who are homozygotes for the~     delta32 mutation for CCR5.~   "
125693|NCT01410331|"~     This is a double-blind, placebo controlled study designed to evaluate the safety and~     efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).~   "
125802|NCT01409148|"~     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive~     monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT~     imaging in patients with AL amyloidosis.~   "
125694|NCT01410318|"~     The overall objective of this study is to characterize the prevalence and progression rate~     of subclinical atherosclerotic lesions and to study their association to the imaging~     characteristics of atheroma plaques and to the presence of genetic, epigenetic, metabolomic,~     and environmental factors, including dietary habits, physical activity, biorhythms,~     psychosocial characteristics, and exposure to environmental pollutants~   "
125695|NCT01410305|"~     The relationship of Vitamin D levels in children and young adults to atherosclerosis.~   "
125696|NCT01410292|"~     The aim of this study is to assess the post-prandial response of four breakfast with~     different content of dietary fiber and glycemic index on glycemic response and satiety in~     patients with type 2 diabetes.~   "
125697|NCT01410279|"~     The purpose of this study is evaluate the effect the inspiratory muscle training on the~     functional capacity of patients with pulmonary hypertension.~   "
125698|NCT01410266|"~     The purpose of this study is to determine whether an alternative method of follow-up after~     medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.~   "
125699|NCT01410253|"~     Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on~     recovery of functional capacity, pulmonary function and respiratory muscle strength in the~     period of hospital stay after coronary artery bypass graft.~   "
125700|NCT01410240|"~     The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of~     care for hemostasis in subjects undergoing total knee arthroplasty.~   "
125701|NCT01410227|"~     The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF,~     and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding~     events in subjects with severe hereditary von Willebrand disease (VWD).~   "
125702|NCT01410214|"~     The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus~     cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete~     resection with EGFR activating mutations and to explore a new treatment strategy for this~     subset.~   "
125703|NCT01410201|"~     The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant~     (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic~     epiretinal membrane (ERM).~   "
125704|NCT01410188|"~     This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in~     the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in~     subjects with primary open-angle glaucoma or ocular hypertension.~   "
125705|NCT01410175|"~     Surgical site infection (SSI) is the second commonest hospital infection, despite advances~     in prevention that have been achieved.~      According to Fernàndes, experimental studies have demonstrated that incorrect use of~     electric scalpels may double the rate of SSI during electrocauterization.~      Because of the lack of solid data in the literature, in relation to the impact on SSI of~     using electric scalpels for making incisions in the skin and all subcutaneous tissues, it~     was judged to be opportune to conduct the present study.~      Objectives:~        -  To compare the incidence of SSI and other complications of the operative wound among~          patients undergoing elective abdominal gynecological surgery at Barretos Cancer~          Hospital, between the use of electric and cold scalpels.~        -  To identify the incidence of SSI and other complications of the operative wound among~          patients undergoing elective abdominal gynecological surgery, when using electric~          scalpels for skin incisions and for subcutaneous incisions.~        -  To identify the main risk factors for SSI among patients undergoing elective abdominal~          gynecological surgery.~   "
125706|NCT01410162|"~     Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or~     twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure,~     renal allograft function, other relevant biochemical parameters and treatment related~     adverse effects.~   "
125707|NCT01410149|"~     Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights~     of polysomnography to record sleep patterns while receiving three modes of mechanical~     ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV),~     Assist control ventilation (ACV), applied in random order. The purpose is to determine the~     effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.~   "
125708|NCT01410136|"~     The overall study objective is to evaluate Chondrofix Osteochondral Allograft (Chondrofix)~     for the repair of osteochondral lesions in the knee. This includes, but is not limited to~     primary cartilage lesion repair and revision of failed prior cartilage repair treatments.~     The study hypothesis is that Chondrofix Allograft will provide pain relief and functional~     improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24~     months of follow-up.~   "
125709|NCT01410123|"~     The study is a series of 3 linked randomized clinical trials of 6 month duration, with a~     total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking~     outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with~     unhealthy alcohol use.~   "
125710|NCT01410110|"~     The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive~     impairments are common during this phase and may reduce the ability to benefit from other~     forms of substance abuse and rehabilitation services. The study compares a rehabilitation~     program that combines work therapy with computer-based cognitive training of attention,~     memory and executive functions to work therapy alone in a 3 months outpatient substance~     abuse program. It is hypothesized that cognitive training will increase days of sobriety~     during the active intervention and better substance abuse outcomes at 6 month follow-up.~   "
125722|NCT01409954|"~     The purpose of this study is to improve fusion (bony healing) techniques and improve patient~     recovery by identifying cells in your body that make bone. Patients with spine problems~     often need surgeries that include fusion (bony healing) of vertebrae (bones in your back)~     together in order to hold the bones steady allowing them to heal together (fusion). If the~     vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can~     result in a slower recovery and may require revision (another) surgery. By using a small~     portion of the graft taken during surgery the investigators hope to define the cells that~     make bone most efficiently. This will help reduce the need for revision surgeries and~     improve patient recovery.~   "
125711|NCT01410097|"~     Obesity is associated with physical disability through both direct pathways (e.g., lower~     extremity pain, insufficient muscle strength) and indirect pathways (obesity-related~     comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health~     condition, is associated with increased risk of disability and accelerated declines in~     physical and cognitive function. The investigators preliminary data suggest that intentional~     weight loss improves physical function, and there is strong circumstantial evidence that it~     would also benefit cognitive function.~      To evaluate the role of intentional weight loss on physical and cognitive function, the~     investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in~     Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the~     effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss~     through decreased caloric intake and exercise in overweight or obese men and women aged~     45-74 years with type 2 diabetes. The investigators propose to add validated and~     well-established measures of physical and cognitive performance to the year 8 follow-up~     visit - during the trial's weight maintenance phase - in ~1000 participants at 4 of the 16~     Look AHEAD field sites (Colorado, Memphis, Pennington and Pittsburgh).~      The specific aims of this ancillary study are: 1) To determine the long-term effects of a~     lifestyle intervention designed to achieve and maintain weight loss on physical function;~     and 2) To determine the long-term effects of a lifestyle intervention designed to achieve~     and maintain weight loss on cognitive function. In addition, the investigators hypothesize~     that in the intervention group, larger initial weight loss, better weight loss maintenance,~     and higher physical activity will be associated with better physical and cognitive function.~     The investigators also hypothesize that in the control group weight loss will be associated~     with worse physical and cognitive function than in those who are weight stable or who have~     gained weight.~      The number of obese older adults is rising rapidly and there are few data to guide an~     evidence-based clinical response to their management. The results of this study will provide~     the first direct evidence of the role of long-term intentional weight loss on the~     maintenance of physical and cognitive function in older obese adults with diabetes. Since~     this study is being done as an ancillary study to an on-going trial it can be done in a~     timely and cost-efficient manner.~   "
125712|NCT01410084|"~     In the past two decades, the role of vitamin D has extended beyond bone health to encompass~     a wide range of biological activities important to physical function in older adults. A~     growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels <~     75 nmol/L (< 30 ng/mL)) are associated with physical impairments such as reduced walking~     speed and impaired balance as well as falls. Older adults are at risk for low levels of~     25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced~     efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from~     the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank~     vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or~     less), vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%)~     among older adults. Older home-bound adults are a vulnerable subgroup of older adults for~     poor dietary intake and nutritional health, nutrition-related health conditions, and~     functional decline and disability. The primary goal of this pilot study is to assess the~     feasibility of a partnership with Senior Services of Forsyth County to address vitamin D~     insufficiency in home-bound older adults receiving home-delivered meals. A secondary goal is~     to obtain preliminary data on the effectiveness of vitamin D supplementation on improving~     vitamin D levels and reducing falls.~   "
125713|NCT01410071|"~     The purpose of this research study is to see if there is a significant difference in~     improvement of symptoms and quality of life of those undergoing endoscopic therapy versus~     those wanting to control their symptoms with medicines or those who just want to wait and~     watch.~   "
125714|NCT01410058|"~     A study will be conducted by scientists from the University of Zimbabwe to determine if~     antiretroviral drugs are affected by taking herbs at the same time. This is important~     because herbal medicines may interact with modern medicine to increase or decrease the~     amount of medication in the body.~      The drugs nevirapine and efavirenz will be studied. Both drugs are routinely used as part of~     combination therapy for treating HIV. In this study it will be determined whether the~     concentrations of the antiretroviral drugs nevirapine and efavirenz are low, high or are in~     the desired range when taken together with the herb moringa.~   "
125715|NCT01410045|"~     Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular~     apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation~     has been used in an effort to preserve fertility in patients undergoing treatments which~     lead to premature and severe ovarian insufficiency. This study aims to assess the relevance~     of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian~     follicular density as primary outcome and karyotypic, clinical and hormonal markers as~     secondary outcomes, analysis of the study will allow to select the patients to whom the~     procedure would benefit the most.~   "
125716|NCT01410032|"~     The purpose of this study is to compare the clinical and radiographic results of patients~     with midshaft clavicular fractures treated with plates or intramedullary flexible nails~     fixation.~   "
125717|NCT01410019|"~     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in~     failure of development of the immune system in boys. This trial aims to treat SCID-X1~     patients using gene therapy to replace the defective gene.~   "
125718|NCT01410006|"~     The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based~     registry that asks participants to fill out a 30-minute online questionnaire to collect~     information about the spectrum of medical and social problems experienced by children and~     adults with NF1. The information gained from your participation may one day help doctors~     develop personalized treatments for individuals living with NF1.~      We are currently enrolling individuals with NF1 who either (1) HAVE previously been~     diagnosed with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor.~     Please note: there is no therapy associated with this study. Individuals may participate in~     the registry by going to https://nf1registry.wustl.edu/~   "
125719|NCT01409993|"~     The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on~     glucose metabolism in persons with prediabetes.~   "
125720|NCT01409980|"~     A triphalangeal thumb is a thumb with three phalanges. The thumb often appears long and~     fingerlike, and can sometimes be in the same plane as the other fingers. Anatomically, the~     extra phalanx can have different shapes. Several classification systems have been used, but~     the simplest and most often used is the Wood (1976) classification by the shape of the extra~     phalanx. If the extra phalanx is triangularly shaped it is classified as a type I. Type II~     has a rectangular shaped extra phalanx but it has not developed as a full phalanx. Type III~     is a full extra phalanx.~   "
125721|NCT01409967|"~     The aim of this work is to study the changes of key assays useful for the understanding of~     anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays,~     hemolysis markers.~   "
125747|NCT01408654|"~     This randomized trial compares peer companionship to care-as-usual in primary care on the~     outcome of risk for suicidal behavior in late life. The investigators hypothesize that older~     adults assigned to receive peer companionship will report greater social connectedness and~     less death and suicidal ideation compared to older adults assigned to care as usual.~   "
125723|NCT01409941|"~     Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to~     demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients~     revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent~     predictor of short and long term mortality in patients undergoing on-pump cardiac surgery.~     Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined~     endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major~     postoperative complications. low cardiac output syndrome, stroke, need of renal replacement~     therapy or reintubation.~      The primary objectives of the present prospective observational study is to determine, if~     there is an association between preoperative ScO2 and postoperative organ dysfunction~     determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic~     peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and~     placental growth factor)~   "
125724|NCT01409928|"~     This is a prospective, non-randomized, single center study of a laparoscopically placed,~     adjustable gastric band medical device for the treatment of adolescent obesity.~   "
125725|NCT01409915|"~     A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested~     for its ability to be tolerated by Alzheimer's disease patients and potentially to improve~     their memory.~   "
125726|NCT01409902|"~     The main objective of the study is to assess the effectiveness of the sheathed speculum in~     providing adequate visualization and access to the cervix in patients with excessive vaginal~     tissue.~      The secondary objective is to rate the patient's comfort evaluation during the sheathed~     speculum examination.~   "
125727|NCT01409889|"~     The purpose of this study is to compare the effectiveness and costs of two programs,the~     Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in~     an primary care practice.~   "
125728|NCT01409876|"~     This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting~     image- guided interstitial brachytherapy in non- metastatic prostate cancer~      Endpoints:~      Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image-~     guided interstitial brachytherapy~      Secondary endpoints~        1. Evaluating tumor response using HistoScanning~        2. Evaluating locoregional recurrence rates by measuring PSA~        3. Analysis of the correlation between tumor response as determined by HistoScanning and~          PSA response~        4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by~          recording serious adverse events~   "
125729|NCT01409863|"~     The goals of this study will be to compare the safety and efficacy of fractional~     photothermolysis (Fraxel) with dermabrasion when used for scar revision.~   "
125730|NCT01409850|"~     The most commonly applied treatment against acute temporomandibular signs and symptoms is~     pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like~     splints) is very low. Two very commonly used splints are the Aqualizer® and the soft~     polyester splint. These are splints applied for a short period of time, until the treatment~     with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical~     short-time efficacy of these two splints for the treatment of acute temporomandibular pain~     and compare it to a control group receiving no therapy for that short time.~      The study hypothesis is that there is a difference in pain reduction between the three~     groups of patients (two intervention and one control group).~   "
125731|NCT01409837|"~     This study was conceived in order to explain what the investigators previously observed~     suggesting that lisinopril, a drug normally used to treat patients with high blood pressure~     and heart failure, may be effective in treating infertile men with low sperm count. The~     investigators hypothesized, therefore, that the drug will not only improve sperm quantity~     and quality but also increase the fertility in such patients. The investigators first of all~     reviewed the results of previously published investigations and found out that there was~     only a few previous studies done in humans.with this class of drugs. Besides, the methods~     used in conducting most of those studies have been so faulted that the results cannot be~     trusted to be showing the true picture. The investigators looked at the various faults~     pointed out with respect to the their design and conduct and took care of them while~     designing the investigators own study. This was an attempt to provide more credible answers~     to the question of whether lisinopril, and possibly other drugs of similar mode of action,~     can be useful in rectifying the problem of infertility caused by low sperm count and , if~     so, whether it will be safe to use it in people who do not have high blood pressure or heart~     failure. In order to achieve this the investigators studied 33 patients with sperm of low~     cell concentration, low percentage of motile cells and high percentage of abnormal cells~     from no known cause. The patients were randomly allocated to receive either lisinopril 2.5mg~     daily (17 patients) or daily placebo (16 patients)and their sperm characteristics were~     examined at intervals, starting from the beginning of the study until when it ended 282~     weeks later. The patients were also monitored for adverse events throughout the period. The~     data form all the patients that took part in the random allocation of treatments at the~     beginning of the study were included in the analysis that followed, irrespective of whether~     they completed the study or not.~   "
125732|NCT01409824|"~     Besides a dramatic lack of financial and human resources in developing countries, health~     care is additionally endangered by quality deficiencies caused by low staff motivation. This~     lack of motivation leads to an insufficient translation of knowledge into optimal~     utilization of resources. The know-do gap represents a challenge that must be addressed to~     strengthen health services performance towards achieving the Millennium Development Goals~     (MDGs). This is in particular true for some sensitive sectors like pre-natal and maternal~     health care. General objective of this research is to improve maternal health through better~     pre-natal and maternal care services offered by better motivated health workers. A~     computer-assisted clinical decision support system (CDSS) will be developed, implemented and~     tested aiming at (I) quality improvement of maternal and newborn care and (II) assessment of~     provider's performance. Based on this tool a commonly agreed incentive scheme to increase~     motivation will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and~     Tanzania.~      The incentive scheme might contain both non-monetary and monetary incentives and will be~     designed according to the human resource policy in the three countries. The planned approach~     is an implementation study with control arms containing one hospital and 6 first line health~     facilities in each of the study districts and an equal number of facilities in the control~     arm. A set of indicators for measurement of changes in quality of delivered services will be~     identified in order to follow up the sustainability and effectiveness of the strategies~     after their implementation. The study findings will allow understanding the important~     factors of staff motivation and facilitate adequate management for improvement of maternal~     and neonatal health care. Knowing is not enough, we must apply; Wanting to do, is not~     enough, we must do it1~      - J.W. v. Goethe~   "
125733|NCT01409811|"~     This pilot clinical trial studies biomarkers in tissue samples from patients with newly~     diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue~     in the laboratory from patients receiving ZA may help doctors learn more about the effects~     of ZA on cells. It may also help doctors understand how well patients respond to treatment.~   "
125734|NCT01409798|"~     The purpose of this registry is to create a database that collects clinical data to improve~     knowledge about primary hyperparathyroidism.~   "
125803|NCT01409135|"~     A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in~     subjects with malignant solid tumors that express Nectin-4.~   "
125735|NCT01409785|"~     The goal of this study is to compare the LMA Unique and LMA Supreme in children having~     surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior~     to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure~     at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view,~     feasibility of use, and complications (airway related, gastric insufflation, trauma) will~     also be assessed.~   "
125736|NCT01409772|"~     The purpose of this study is to evaluate the clinical practice of the prophylactic use of~     ethanol locks for the prevention of catheter related blood stream infections in pediatric~     intestinal rehabilitation program patients requiring total parenteral nutrition.~   "
125737|NCT01409759|"~     Objective: to evaluate the perforator based interposition plasty in comparison to the~     standard technique (full thickness graft) for scar contracture releases.~      Study design: A randomised controlled multicentre intervention study.~      Study population: Patients, aged 18 years and older, who require surgery for release of a~     scar contracture, are eligible for this study. In total 50 patients will be recruited with a~     follow-up of 3 months post-operatively.~      Intervention: A release of the contracture will be performed in combination with òr the~     standard technique (full thickness graft) òr the perforator based interposition plasty.~      Main study parameters/endpoints: the main study parameter is the amount of contraction of~     the flap/graft after three months.~   "
125738|NCT01409746|"~     The purpose of this study is to study the role of genes and environment in early brain~     development using a twin approach. The investigators will use magnetic resonance imaging~     (MRI) to study brain structure and it's relationship to cognitive development. Specifically,~     the investigators will study cortical gray and white matter volumes, volumes of subcortical~     structures and cerebellum, as well as diffusion properties in major white matter tracts~     using DTI tractography.~   "
125739|NCT01409733|"~     The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in~     melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20~     patients, this is a feasibility study. the patients profile is patients with stage IV~     Melanoma with liver metastases.~   "
125740|NCT01409720|"~     Standard indications for palliative radiation of bony metastases include pain, spinal cord~     compression, and impending pathologic fractures.~      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid~     complications. Tailored training of the paravertebral musculature may support radiation~     therapy and improve above named factors. DISPO was designed to investigate the impact of~     tailored physical exercise in patients with vertebral metastases as compared to manual~     therapy (massage etc.). The trial includes patients with painful bony metastases, patients~     with spinal cord compression or impending pathological fractures are excluded. The~     investigations are carried out in a prospective randomized controlled phase-II parallel~     group design.~   "
125741|NCT01409707|"~     The purpose of this study is to test if provision of an effective psychotherapy for~     Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol~     dependent patients with PTSD and if it is associated with better treatment outcomes compared~     to an active control condition.~   "
125742|NCT01409694|"~     The purpose of this study is to compare the effect after 24 weeks of the oral intake of~     vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive~     performance in patients suffering from moderate Alzheimer's disease or related disorders~     (ADRD) and receiving memantine.~   "
125743|NCT01409681|"~     Vitamin D exerts antiproliferative and differentiating effects in cancers, including~     non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25,~     dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450~     24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of~     successive hydroxylation/oxidation reactions. This study seeks to prospectively determine~     the relationship between Vitamin D gene expression and median survival as a primary outcome,~     and between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking~     status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.~   "
125744|NCT01409668|"~     This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing~     yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as~     gastrointestinal microflora distribution in hyperlipidemic individuals.~   "
125745|NCT01409655|"~     Our proposal Centralized Off-Site Adherence Enhancement Program or CARE will develop and~     test an effective behavioral adherence intervention program for HIV patients with alcohol~     and/or substance abuse problems. This project will develop and pilot test a novel program to~     help patients with alcohol and/or substance abuse problems take their medications as~     prescribed. The intervention will be delivered by phone, and utilize electronic monitoring~     of medication-taking, so patients can be treated by therapists from any geographic distance.~     To safely monitor data collected for this study, we have laid out a detailed Data Safety~     Monitoring Plan, which will cover all the issues required by NIDA.~   "
125746|NCT01409642|"~     Pediatric obsessive compulsive disorder (OCD) is a chronic, impairing condition that accrues~     significant concurrent and long-term risk to affected youth (Piacentini et al. 2003; Pine et~     al. 1998). Although a host of pharmacological and psychosocial treatments have proliferated~     over the past decade (Barrett et al., 2008), many youth fail torespond to treatment and many~     who do respond continue to exhibit lingering symptoms and impairment. Thus, there is still~     much to be done by way of optimizing treatment outcomes for pediatric OCD.~      Increasingly, efforts to improve existing treatments have focused on aspects of the family~     environment that may affect treatment adherence and the maintenance of therapeutic gains.~     Such work suggests that parental accommodation and criticism are common characteristics of~     the home environment for both adults and children with OCD (Calvocoressi et al., 1999;~     Peris, Roblek, Langley, Chang, McCracken, & Piacentini, 2008; Van Noppen et al., 1991) and~     that, in adult samples, these family features are associated with poorer treatment outcome~     and greater risk of relapse (Amir, Freshman, & Foa, 2000; Chambless & Steketee, 1999;Leonard~     et al., 1993). These family-level variables are logical targets for intervention,~     particularly among treatment refractory groups of youth with OCD. However, they often are~     unaddressed in extant interventions.~      The current study tests a novel intervention that specifically targets family accommodation~     and conflict in an effort to foster an environment that supports a graded exposure approach~     to treatment. The proposed treatment, Positive Family Interaction Therapy (PFIT), is~     composed of an innovative blend of techniques that address several potential barriers to~     treatment. First, the treatment is guided by the specific needs of youth with OCD and their~     families (e.g., accommodation, conflict). The first phase of the proposed study will involve~     an open case series in order to assess the utility of the PFIT protocol and feasibility of~     training other therapists and using the manual with a range of patient presentations. The~     second phase will involve a small controlled feasibility trial evaluating the extent to~     which recruitment, randomization, and implementation of the control condition are viable for~     further study. It is hypothesized that the PFIT treatment will be feasible to implement and~     will yield higher levels of patient satisfaction compared to treatment as usual.~   "
125748|NCT01408641|"~     Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder~     (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more~     difficult than treating AUDs in the general population. The FDA-approved medication~     topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has~     also improved symptoms in people with PTSD. This study is designed to investigate whether~     topiramate will improve drinking outcomes in Veterans with PTSD.~   "
125749|NCT01408628|"~     The primary purpose of the study is demonstration that teaching insulin management in small~     groups of type 2 diabetes patients in 4 weekly live Internet sessions is safe and provides~     an important resource for rural diabetes care providers who may otherwise, because of lack~     of time or staff, not be able to put patients on insulin who need it.~   "
125750|NCT01408615|"~     This observational study will examine the safety and efficacy profile of Elonva~     (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian~     stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for~     the development of multiple follicles in an assisted reproductive technology (ART) program.~   "
125751|NCT01408602|"~     This study will treat moderate to severe rheumatoid arthritis with MRC375 (either 75 mg 3~     times a day, 150 mg 3 times a day or placebo 3 times a day)in patients 18 years of age or~     older that can be currently on low doses of methotrexate or can stop treatment of current RA~     medications to enter the study. Safety of MRC375 will also be evaluated. There are up to 8~     clinic visits over 24 weeks.~   "
125752|NCT01408589|"~     This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40,~     60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited~     craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the~     fact that it targets NET, neither of which has heretofore been examined in the context of~     alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will~     provide the PI with sufficient preliminary data to submit a subsequent R01 application to~     study atomoxetine and the involvement of specific single nucleotide polymorphisms within the~     NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations.~     The long-term objective of this research is to develop more efficacious treatment~     interventions for alcohol abuse and dependence.~      Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of~     atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than~     subjects who receive a placebo.~      Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of~     atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective~     intoxication) than subjects who receive a placebo.~   "
125753|NCT01408576|"~     The primary objective of the study is assess the safety and tolerability of long-term~     epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)~   "
125754|NCT01408563|"~     This trial will use two cord blood units for transplantation using a reduced intensity~     regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord~     blood units (double cord blood) are being used, as the numbers of blood cells in one unit~     are too few to allow successful growth of these cells.~      Because the risk of infection, particularly virus infection, is high after double cord blood~     transplant, this study seeks to reduce the rise of virus infection by using a reduced~     intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior~     cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and~     fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The~     number of patients with virus infections in this study will be compared to our prior~     experience using the ATG.~   "
125755|NCT01408550|"~     Patients diagnosed with bullous pemphigoid were confirmed based on the investigators~     national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict~     with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day~     for five consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01~     for therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area~     index (PDAI) and pemphigoid activity score involving skin lesion area and Number of new~     blisters.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by 57 days after the start of the study treatment.~   "
125756|NCT01408537|"~     Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia~     including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the~     total number of clinical cases is about 50,000. Of these cases, about 50% result in~     permanent neuropsychiatric sequelae. The disease occurs mostly among children aged <10~     years. There is no specific antiviral treatment for JE. Vaccination is the single most~     important control measure. This study aims to evaluate the immunogenicity and safety of~     inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da~     Biotechnology Co., Ltd, China JEVAC in Thai children.~      152 healthy Thai children aged between 1-3 years will be vaccinated with JEVAC in a dose~     of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year~     (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at~     one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13~     months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing~     P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious~     adverse events will be observed throughout the study period.~   "
125757|NCT01408524|"~     The purpose of this study is to determine the effectiveness of the antihypertensive drugs in~     the control of emergence blood pressure after tumor resection craniotomy; compared between~     labetalol (Avexa) and diltiazem (Herbessor).~      Also the investigators seek to determine the effective dose of the antihypertensive drugs~     and their side effects in Thai population.~   "
125758|NCT01408511|"~     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat~     0.1% ointment in adults with atopic dermatitis.~   "
125775|NCT01409499|"~     The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and~     its efficacy is limited. More active treatments were performed in patients with advanced HCC~     in China, which include radical hepatectomy or TACE. The study is to investigate whether the~     active treatment will profit survival of patients, and to evaluate the safety.~   "
125759|NCT01408498|"~     The study aims to establish a clear causal link between testosterone and threat perception~     and behavioral responses to threat. Namely, the study focuses whether high levels of~     testosterone will cause an individual to exhibit increased physiological responses to threat~     (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased~     behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing~     with the threat). The threat in this study is a social threat involving public speaking, and~     is an outgrowth of previous research on the avoidance of health threats.~   "
125760|NCT01408485|"~     To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is~     effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its~     use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse~     events.~   "
125761|NCT01408472|"~     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to~     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in~     diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide~     neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in~     glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into~     one eye, and will be carefully followed to evaluate safety and efficacy.~   "
125762|NCT01408459|"~     The purposes of this study are to explore the dynamics of adherence, using a simple whole~     food intervention strategy, both prior to and during the intervention period and to identify~     nutrient shifts in self-selected diets and to determine health risks (blood pressure,~     hyperlipidemia, and body weight) that may have resulted from increased tomato product~     consumption.~   "
125763|NCT01408446|"~     Prehypertension and mild hypertension are associated with an increased risk of~     atherosclerosis and coronary artery disease, and often complicated with the metabolic~     disorder of glucose and lipid. The comprehensive prevention of hypertension is still an~     important and complex clinical issue. Peppermint is a popular flavoring agent, and~     peppermint tea help relax tension and could lower blood pressure. The effect of oral~     peppermint on blood pressure is not consistent, however, our previous animal study has shown~     that oral administration of menthol, the main component of peppermint, could reduce 24-hour~     mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats.~     Furthermore, menthol increases uncoupling protein(UCP)1 dependent thermogenesis and energy~     expenditure through transient receptor potential melastatin(TRPM)8 activation, and helps~     prevent obesity and metabolic disorders. In a prospective, double-blind, randomized, and~     parallel-group study, we will evaluate the effects of DANSHU capsule(menthol) on blood~     pressure and metabolic parameters in prehypertensive and mild hypertensive patients. This~     study will help develop future comprehensive prevention and treatment strategies for~     hypertension.~   "
125764|NCT01408433|"~     This study seeks to compare the pregnancy and delivery rates of patients who undergo a~     single embryo transfer, when the embryo has been tested and determined to be chromosomally~     normal, with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer~     of untested embryos.~   "
125765|NCT01409629|"~     Study of activity choices after playing a computer game.~   "
125766|NCT01409616|"~     The primary objective of this study is to evaluate whether ASA, the combination of ASA and~     clopidogrel, and darexaban, which have different effects on blood coagulation, influence~     each other in their effects. Also it will be investigated whether the blood levels of either~     drug are influenced by the presence of the other drug. In addition, the safety and~     tolerability of each drug and the combination of the drugs will be investigated.~   "
125767|NCT01409603|"~     The primary objective of this study is to evaluate whether naproxen and darexaban which have~     different effects on blood coagulation influence each other in their effects. Also it will~     be investigated whether the blood levels of either drug are influenced by the presence of~     the other drug. In addition, the safety and tolerability of each drug and the combination of~     the drugs will be investigated.~   "
125768|NCT01409590|"~     In this study the investigators will recruit patients with the diagnosis of schizophrenia~     that are taking atypical neuroleptics and that are willing to participate in an exercise and~     diet program. The investigators will measure weight and abdomen circumference.~   "
125769|NCT01409577|"~     The investigator will evaluate the clinical outcomes of the patients in whom the treatment~     strategy for their coronary stenosis were determined by fractional flow reserve measurement.~   "
125770|NCT01409564|"~     The purpose of this study is to examine the effects of cilostazol augmentation in mild to~     moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI)~     treated by donepezil.~      Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10%~     of the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to~     moderate dementia, but these drugs only relate to symptomatic improvement and the response~     rates are less than 30%.~      Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and~     used as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates~     phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein~     (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to~     neurodegeneration prevention.~      The investigators will try cilostazol augmentation in dementia patients with WMHI receiving~     donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.~   "
125771|NCT01409551|"~     Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural~     effusions, in terms of safety and efficacy.~   "
125772|NCT01409538|"~     This study examines the brain activation associated with placebo pain reduction.~   "
125773|NCT01409525|"~     The purpose of this observational, exploratory study in patients undergoing any cardiac~     valve replacement or repair is to assess the rate of bacterial colonization over native~     degenerative calcified cardiac valves.~   "
125774|NCT01409512|"~     The aim of the study is to evaluate changes in autonomic nervous system following treatment~     with anticholinergic medication for OAB symptoms.~      Heart variability as a measure of the functioning of the autonomic nervous system will be~     recorded before and three months following treatment with solifenacin succinate 10 mg daily.~   "
128426|NCT01374490|"~     This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg~     twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive~     (HIV+) subjects with diarrhea.~   "
125777|NCT01409473|"~     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)~     with simultaneous boost (higher radiation dose) to areas within the prostate with more~     prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated~     radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with~     low- and intermediate-risk localized prostate cancer.~   "
125778|NCT01409460|"~     The purpose of this study is to evaluate how many patients require the addition of the~     obturator nerve block in the recovery room after the total knee surgery. Also to study the~     efficacy of blocking the obturator nerve in controlling their knee pain.~   "
125779|NCT01409447|"~     Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently~     used to treat cartilage defects. The investigators had previously developed a biphasic~     osteochondral composite as the construct for chondrocyte implantation. The investigators~     further conducted this feasibility study of such device to treat patients with osteochondral~     lesion of the knee joints.~   "
125780|NCT01409434|"~     This is a research study of the long term effects on blood sugar and cholesterol of blood~     pressure lowering medications. People are invited to participate in this research study if~     they participated in the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR 1,~     NCT00246519 or PEAR 2, NCT01203852) study and are still taking a thiazide diuretic. In PEAR,~     the effects on blood pressure, blood sugar, and cholesterol of the high blood pressure drugs~     hydrochlorothiazide and atenolol over an 18 week period were evaluated. This PEAR follow-up~     study will determine the effects of thiazide diuretics on blood sugar and cholesterol, but~     in the period since the PEAR trial. The study hypothesis is that long term exposure to~     thiazide diuretics results in larger increases in blood sugar and cholesterol levels than~     short term exposure.~   "
125781|NCT01409421|"~     The investigators are studying motivational interviewing (MI). MI is a counseling method to~     help people adopt healthy behaviors. The investigators will test whether MI improves~     patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff~     called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All~     patients will receive their usual eye care. Based on chance, some patients will also be~     supported by a glaucoma educator. The groups will be compared on medication adherence using~     micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a~     medication bottle is opened. Patients will be aware that their medication use is tracked.~     The groups will also be compared on treatment value, outcomes, and cost. The investigators~     will also collect data on variables that may predict medication adherence.~   "
125782|NCT01409408|"~     Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and~     compare theses effects and renin activity and concentration to those obtained with a calcium~     channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure~     not controlled by 100 mg per day of losartan.~   "
125783|NCT01409395|"~     This study will address the following question: Does nizatidine affect the pharmacokinetics~     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have~     indicated that nizatidine may block metformin elimination from the kidney by inhibiting~     organic cation transporter efflux of metformin. The investigators hypothesize that the~     co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of~     metformin leading to increased plasma concentrations and potential risk for toxicities.~     Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter~     inhibitors, such as nizatidine, is important to help develop safer more effective drug~     therapy with reduced side effects.~   "
125784|NCT01409382|"~     tPA has a pivotal role in placentation, mediationg activation of growth factors, such as~     vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of~     extracellular matrix and basement membrane (directly or through activation of matrix~     metalloproteinases) and formation of hemidesmosomes.~      A high-carbohydrate intake combined with lack of physical activity provides a strong~     stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional~     and diabetes supervenes, or excessive amounts of insulin are produced, providing~     pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor,~     PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm~     deliveries and intrauterine growth restriction.~      Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a~     parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of~     insulin.~   "
125785|NCT01409369|"~     This open-label, two period crossover study will evaluate the effect of multiple doses of~     activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy~     volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated~     by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with~     the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In~     period 2, only a single dose of RO4995819 but no activated charcoal will be administered.~   "
125786|NCT01409356|"~     Overweight/obesity is increasing both in the general population and in patients with~     cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for~     clinical decompensation independent of liver function and portal pressure. Nonetheless,~     patients with cirrhosis and obesity show a progressive increase in portal pressure, which~     might explain their increased risk of complications. Since obesity is a potentially~     modifiable risk factor, we designed this proof-of-concept study to assess the effects of~     weight loss (obtained by 4 months of diet and exercise) on portal pressure in patients with~     compensated cirrhosis and overweight/obesity.~   "
125787|NCT01409343|"~     This is a prospective, open label, multicenter study evaluating the safety, tolerability and~     pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2~     positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on~     tumour response will also be evaluated.~   "
125788|NCT01409330|"~     Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2~     diabetes.~      This study aims to explore the effect of diet lacking red meat, but containing increased~     fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.~   "
126056|NCT01405573|"~     The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best~     supportive care with best supportive care alone in terms of survival in patients with~     hepatocellular carcinoma (HCC) with impaired liver function (Child B).~   "
125789|NCT01409317|"~     Standard high frequency repetitive transcranial magnetic stimulation (HF-TMS) is a~     noninvasive method to activate or de-activate neurons in superficial regions of the brain~     through the induction of weak electric currents in the brain tissue produced by rapidly~     changing magnetic fields. Studies have generally shown standard HF-TMS to be effective in~     treating major depressive disorder (MDD), although treatment effects are often highly~     variable and there are several negative trials in the specialized literature. One reason for~     these discrepant results might be that standard HF-TMS only enables direct stimulation of~     superficial brain areas and, consequently, it is possible that the stimulation of deeper and~     more widespread brain regions could produce superior and more reliable results. Recently, a~     novel form of HF-rTMS (called deep transcranial magnetic stimulation or DTMS), that allows~     direct stimulation of much larger and deeper brain regions, has also been shown to be~     effective and safe in treating MDD. Neuroimaging studies have shown that standard HF-rTMS~     directly affects several superficial areas of the brain, but to date there is no data on the~     brain effects of DTMS. Thus, this study aims to explore, for the first time, the brain~     effects of DTMS in MDD. More specifically, we, the investigators, hope to identify possible~     neural predictors of clinical improvement after DTMS and also clarify the impact of DTMS in~     the brain activity over time. In this study, DTMS will be applied over the left side of the~     front of the head (a region known as the 'prefrontal cortex'), and will be compared with~     standard HF-TMS in terms of its effectiveness and brain effects. For this, subjects with at~     least moderate MDD will be randomized to receive daily DTMS or standard HF-rTMS treatment~     for 4 weeks, and will undergo functional magnetic resonance imaging (fMRI) before and after~     treatment. fMRI is a neuroimaging technique that allows us to measure which areas of the~     brain are more or less 'active' in response to specific stimuli at a particular time. During~     the fMRI sessions, we will use a validated cognitive task on working memory. Our results~     could eventually lead us, among other things, to identify which depressed patients would be~     best candidates for receiving either standard HF-rTMS or DTMS, and which areas of the brain~     should be targeted by these neuromodulation techniques.~   "
125790|NCT01409304|"~     We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel~     brain stimulation technique, is effective for treating major depression. We hypothesize that~     4 weeks of DTMS will be associated with significant improvements in depressive and anxious~     symptoms without significant side effects.~   "
125791|NCT01409291|"~     Many Americans are living paycheck to paycheck. This may lead to financial stress and an~     increase in overall stress. People under stress are more likely to smoke, consume alcohol,~     eat a poor diet, and experience depression or anxiety. Experiencing financial stress may~     also increase the risk for heart disease. The purpose of this research study is to test~     whether participating in the Financial Success Program improves health outcomes, in both the~     women participating and their children.~   "
125792|NCT01409278|"~     The purpose of this study is to examine three different ways to control pain after hip~     replacement:~        1. One time injection of ropivacaine before wound closure~        2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine~          via catheter for 48 hours~        3. Standard practice of patient controlled pump~   "
125793|NCT01409265|"~     The perceptual change on stroke patients during the movement recovery and its relationship~     with social participation still remain unclear. The purposes of this study are: 1) to~     observe the progression of perception deficit and 2) to understand the relationships among~     perception deficit and other functional indicators.~      A total of 90 stroke patients will be recruited. Each patient will receive three times~     evaluation, including perception tests, motor function test, daily living ability tests and~     social leisure participation questionnaires.~   "
125794|NCT01409252|"~     The investigators retrospectively reviewed all patients with neurosurgical operations for~     hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then~     telephoned the survivors for neurological and cognitive status.~   "
125795|NCT01409239|"~     Glycemic variability has been associated with mortality in hospitalized patients with~     hyperglycemia. However, it is unknown how modulation of glycemic variability would impact~     outcomes. One possibility is that glycemic variability could impact autonomic tone. In~     particular, heart rate variability (HRV) measurement is a sensitive marker for measuring~     autonomic tone, and aberrations in HRV have been associated with mortality. The current~     randomized pilot study will compare the effects of continuous intravenous (IV) insulin and~     subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized~     non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic~     or are requiring at least 20 units of insulin per day will be included. Patients with~     conditions that preclude accurate HRV readings (such as atrial fibrillation or paced~     rhythms) will be excluded. Patients randomized to intravenous insulin will receive the~     therapy for 24 hours according to our standard hospital guideline. Patients randomized to~     subcutaneous (SQ) insulin will receive basal bolus therapy using insulin analogues. All~     therapies will begin between 8 and 10 AM. Patients will undergo repeated heart rate~     variability recordings during the 24 hour period. Blood draws will be collected at baseline~     and at 24 hours for measurement of catecholamines, insulin, and c-peptide. Glycemic~     variability will be measured using a continuous subcutaneous glucose monitor and reported as~     coefficient of variation. The primary outcome measure is low frequency-to-high frequency~     power spectrum ratio of heart rate variability.~        1. Glycemic variability is associated with unfavorable changes in autonomic tone, as~          assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in~          overall glycemia.~        2. Short-term increases in glycemic variability, followed by more prolonged glycemic~          stability are observed in generalized hospitalized patients treated with intravenous~          insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects~          receiving intravenous compared to subcutaneous insulin.~        3. Glycemic variability differs among subjects receiving intravenous compared to~          subcutaneous insulin~   "
125796|NCT01409226|"~     This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve~     in diagnosing breast cancer in women with high-risk of breast cancer.~   "
125797|NCT01409213|"~     The purpose of this study is to collect information of the risk profile of patients with~     type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of~     diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October~     13, 2008~   "
125798|NCT01409200|"~     The goal of this clinical research study is learn if adding axitinib to hormonal therapy can~     help to control prostate cancer when given before surgery. The safety of this drug will also~     be studied.~   "
125799|NCT01409187|"~     The goal of the Phase I part of this clinical research study is to find the highest~     tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A~     (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma.~     The safety of this combination will also be studied in Phase I. The goal of Phase II is to~     learn if this combination can help to control metastatic melanoma.~      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells~     that decrease the immune system's ability to fight cancer.~   "
125800|NCT01409174|"~     The goal of the Phase I part of this clinical research study is to find the highest~     tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar~     (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol~     (cisplatin) to patients with metastatic melanoma. The safety of this combination will also~     be studied in Phase I. The goal of Phase II is to learn if this combination can help to~     control metastatic melanoma.~      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells~     that decrease the immune system's ability to fight cancer.~      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~      Cisplatin is designed to poison the cancer cells, which may cause them to die.~   "
125804|NCT01409122|"~     This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite~     inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses~     with steady-state sildenafil (Part B) to healthy male and female subjects, as well as~     assessment of the safety and tolerability of multiple doses of AIR001 to patients with~     pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing~     three different nebulizers (Part D).~   "
125805|NCT01409109|"~     Several observations have been made with magnetic resonance imaging (MRI) that characterize~     brain connections and brain function in individuals with schizophrenia and other mental~     disorders. For example, research investigating schizophrenia focuses on the dysfunction of~     connections within and between the medial temporal lobe and the prefrontal cortex as well as~     other pertinent brain regions. This database registry will allow for the collection of~     clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and~     functional magnetic resonance imaging (fMRI) data on individuals with and without mental~     disorders to better understand how connections in the brain and various brain regions~     function differently while volunteers perform various cognitive tasks. This is an~     observational study that is being conducted to collect data and place it in a registry for~     current and future investigational questions related to imaging in mental disorders.~   "
125806|NCT01409096|"~     Primary purpose of this study is to determine if pregnenolone supplementation is associated~     with greater improvement in depressive symptoms of patients with bipolar disorder. Also the~     study will explore possibilities of improving anxiety and manic symptoms as well as the~     patient's cognition.~   "
125807|NCT01409083|"~     Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The~     increase in carbon dioxide production can be detected by measuring the exhaled carbon~     dioxide in the lungs.~      This study is conducted to access the clinical application of measuring exhaled carbon~     dioxide to verify the correct position of intravenous catheters.Once the catheter is in the~     correct position the injected bicarbonate will be detected as a distinct elevation of~     exhaled carbon dioxide. A similar study was already performed in adults and was found~     useful. The investigators now extend the clinical application to children.~   "
125808|NCT01409070|"~     In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have~     been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been~     evaluated the head to head comparison of two drugs. This study is a retrospective study to~     compare the efficacy of two drugs.~   "
125809|NCT01409057|"~     Since selenium has demonstrated significant characteristics for a series of biochemical~     processes, for antioxidant activity and immune stimulation, this observational study should~     represent the effect of heart-lung-machine on selenium status of cardiac surgical patients~     undergoing coronary bypass surgery. It will be examined in (approximately 100) adult~     patients, under which 50 patients are operated conventionally (meaning with the use of~     heart-lung-machine). Another 50 patients are operated on beating heart without the use of~     heart-lung-machine (OPCAB = off pump coronary artery bypass). The allocation of individual~     patients in these two groups is done according to clinical criteria and is undertaken by the~     operating surgeon.~   "
125810|NCT01409044|"~     Background:~      - Studies have shown that listening to music can decrease pain and anxiety. Following~     surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and~     anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If~     listening to music can help lower pain and anxiety levels, less medication might be needed~     and these side effects could be avoided.~      Objectives:~      - To determine the effects of music on patient pain and anxiety in the first few days after~     surgery.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have surgery that requires a~     24-48-hour stay in intensive care afterward.~      Design:~        -  All participants will be screened with a medical history before having surgery.~        -  Participants will be divided into two groups: one group will listen to music after~          surgery, and the other will not.~        -  Before surgery, participants will answer questions about their pain and anxiety levels.~          They will also be shown how to control the device that lets them administer their own~          pain medication after surgery.~        -  Following surgery, all participants will be transferred to the ICU and will answer the~          same questions about pain and anxiety levels.~        -  The music group will listen to a specially created CD of instrumental music for about~          50 minutes, four times a day. The standard group will not listen to this music. All~          other treatments will be the same in both groups. Both groups will continue to answer~          the same questions about pain and anxiety levels.~        -  Participants will have a final 15- to 20-minute interview after leaving the ICU. They~          will answer questions about the ICU stay and (for those in the music listening group)~          the music.~   "
125811|NCT01409031|"~     The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary~     artery pressure and improves oxygenation in near-term and term infants with persistent~     pulmonary hypertension.~   "
125812|NCT01409018|"~     This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its~     active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the~     development of invasive fungal disease.~   "
125823|NCT01408862|"~     Novel drugs for the treatment of patients with diabetes are of interest for cardiologists if~     they reduce the risk of cardiovascular events. However, as documented by the current~     discussion about the potential benefits of glitazones, high hopes can fail. Initial~     beneficial cardiovascular effects shown in proof-of-concept studies were muted by the~     apparent higher mortality in the metaanalysis of studies with rosiglitazone. The rapidly~     increasing use of GLP-1 analogues and DPP-4 (Dipeptidyl protease 4) inhibitors for the~     treatment of type 2 diabetes mellitus may be of major interest for the cardiologist.~     Potential beneficial actions on the cardiovascular system so far shown in animal experiments~     and small proof of concept studies may provide the rationale for using these drugs~     specifically in diabetic patients with secondary complications such as macrovascular disease~     or diabetic cardiomyopathy. Theoretically, these new therapies could also proof beneficial~     in patients with heart failure, independently of concomitant diabetes mellitus. However,~     many unanswered questions need to be addressed in the near future to extend the experimental~     findings to potential benefits of real life patients. In summary a new class of antidiabetic~     drugs, which could possibly directly influence cardiovascular effects of diabetes mellitus~     and thus possibly treat or even prevent life threatening complications has become available.~      Then our working hypothesis was that incretins may have desirable cardiovascular outcomes~     through modulating platelet function. In order to test this hypothesis we propose to assess~     the presence of their specific receptors in isolated human platelets. In addition, we~     proposed to sudy the effect of the endogenous incretins (glucagon-like peptide 1 and gastric~     inhibitory peptide) on human platelet function isolated in a test tube.~   "
125813|NCT01409005|"~     Although there have been remarkable advances in the treatment of metastatic or recurrent~     colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC~     because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC~     patients who can undergo complete resection (metastasectomy). Until now, approved cytotoxic~     drugs for treatment of MCRC are only 3 categories (fluoropyrimidine, oxaliplatin and~     irinotecan). Recently, molecularly targeted drugs are approved for MRCRC patients, and~     bevacizumab and cetuximab (for K-ras wild type tumors) are available. When cytotoxic and~     targeted drugs are appropriately combined, about 24 months of overall survival (OS) can be~     expected in patients with MRCRC. However, when these drugs are all used or patients cannot~     afford to receive expensive targeted drugs because of economical problems, there is no~     option for chemotherapy and best supportive care is the only option, although some patients~     still have good performance status and medical conditions. Therefore, there are unmet needs~     for additional salvage chemotherapy regimens for patients with oxaliplatin, irinotecan and~     fluoropyrimidine-refractory MRCRC.~      In some previous studies, gemcitabine-based chemotherapy showed some antitumor activities in~     MRCRC patients. Especially, when combined with fluoropyrimidine, gemcitabine has been shown~     to exert synergic effects on antitumor activities. On these backgrounds, this phase 2~     clinical study was designed. In this study, efficacy and safety of gemcitabine plus UFTE~     chemotherapy will be evaluated in MRCRC patients.~   "
125814|NCT01408992|"~     This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes~     Hearing test against the audiometry to screen hearing problem in community.~   "
125815|NCT01408979|"~     Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal~     duration of this treatment after delivery is still to be established. The hypothesis is that~     in stable patients a shorter course of treatment is possible without prejudice to the~     mother.~   "
125816|NCT01408966|"~     This study was aimed at testing the hypothesis that supplementing a meal with dark~     chocolate, which holds potent antioxidant properties, might attenuate the postprandial~     increase in the hepatic venous pressure gradient (HVPG, clinical equivalent of portal~     pressure) in patients with cirrhosis~   "
125817|NCT01408953|"~     Keloid is chronic skin conditions that results in formation of tumor like growths on the~     skin. Despite its benign nature, keloid can cause severe aesthetic and, in some cases,~     functional problem which negatively impacts person's quality of life.~      Keloids do not regress on their own and results of most available treatments such as~     surgery, injecting keloids with steroids, chemotherapy injections, or even radiation~     therapy, have mostly proven disappointing.~      Some laboratory studies have shown that there is excessive amount of a protein called~     vascular endothelial growth factor (VEGF) in keloid tissue. This may play role in the~     formation and evolution of keloid.~      Bevacizumab is a drug that works by targeting vascular endothelial growth factor (VEGF)~     which helps new blood vessels form. Without new blood vessels, the growth of the keloid may~     be slowed~      Based on presence of excess amount of VEGF in keloid tissue, we hypothesize that bevacizumab~     will be effective in treatment of keloids. This exploratory clinical trial is to confirm or~     reject this hypothesis.~   "
125818|NCT01408927|"~     The primary objective of this prospective clinical registry is to determine the prevalence~     and level of thienopyridine resistance seen in a population undergoing contemporary~     percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).~   "
125819|NCT01408914|"~     The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to~     shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses~     are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood~     concentrations will result in tuberculosis bugs being killed more quickly; and, both of~     these will happen without more adverse events. Patients with active, infectious,~     drug-susceptible TB who agree to participate will be randomly assigned to 1 of 3 doses of~     RIF. All patients will also receive standard doses of regular (3) companion drugs for 2~     months of daily, supervised therapy. The study will assess the following among the 3 study~     arms (oral doses of RIF 10, 15 & 20 mg/kg/day) during the initial 8 weeks of treatment: 1)~     the amount of RIF in the blood after at least 14 days of treatment; 2) the difference in the~     number of tuberculosis bugs killed; 3) the frequency of adverse events.~   "
125820|NCT01408901|"~     The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill~     exercise will significantly improve functional performance in patients with PAD more than~     GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel~     therapeutic options for patients with PAD, the current proposal is expected to identify~     mechanisms by which functional impairment is improved in patients with PAD.~   "
125821|NCT01408888|"~     The purpose of this study is to study the effect of LY2189265 on how the body absorbs and~     processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects~     LY2189265 when they are taken together.~      The duration of participation in this study is expected to be approximately 61 days. The~     study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).~      The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily~     doses of 100 mg sitagliptin tablets administered orally.~   "
125822|NCT01408875|"~     The purpose of this study is to determine if addition of low frequency~     electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity~     and/or muscular strength in chronic heart failure patients.~   "
125824|NCT01408849|"~     This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia~     Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is~     SODA score, secondary endpoint is endoscopic classification (Sydney).~   "
125825|NCT01408836|"~     The purpose of this study is to test whether additional therapy with plasma exchange~     improves the chances of kidney recovery in severe kidney vasculitis.~   "
125826|NCT01408823|"~     This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic~     acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's~     Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the~     literature for this population and currently in use at CHOP.~   "
126753|NCT01396473|"~     The purpose of this study is to design and conduct research to tailor out of school time~     evaluation materials so they are applicable to various settings in Boston, are efficient in~     that minimal resources and time are used, and are useful to participants.~   "
125827|NCT01408810|"~     The aim of this study is to assess the relationship between microscopic Geboes index of~     inflammation and clinical course of ulcerative colitis in patients treated with infliximab.~     The investigators propose to test the hypothesis if infliximab is able to induce~     histological remission and then change the clinical course of ulcerative colitis.~   "
125828|NCT01408797|"~     The objective of this trial is to determine if clonal deletion before kidney transplantation~     can effectively reduce the need for post transplant immunosuppression. The investigators~     will adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to~     assess the effect of clonal deletion and closely monitor acute rejection, renal function,~     and graft survival. 15 patients eligible for the study as described below will be enrolled.~   "
125829|NCT01408784|"~     The purpose of this study is to assess the validity of self-caloric evaluation, the~     categories method - a new method based on one categorical score per meal~   "
125830|NCT01408771|"~     The purpose of this study is to find out whether swallowing has an effect on the degree of~     urinary urgency and on the amplitude of detrusor contraction during filling cystometry in~     patients with detrusor overactivity (DO).~   "
125831|NCT01408758|"~     The Virtual Clinician Research Tool (VCRT) will use a virtual format to present our National~     Cholesterol Education Program (Brown, 2004) and the Tobacco Use and Dependence Treatment~     Clinical Guideline (Fiore et al., 2008) integrated with principles of human motivation from~     Self-Determination Theory (SDT) for patients with elevated risk for cardiovascular disease~     from LDL-cholesterol or tobacco dependence.~   "
125832|NCT01408745|"~     The primary objective is to establish if the SternumFix System improves sternal closure. The~     study should test the hypothesis that in a high risk patient population with increased risk~     for the development of sternal wound complications SternumFix will reduce the incidence of~     sternal healing complications. The control group will be treated with wire cerclage, the~     standard method of sternal closure.~   "
125833|NCT01408732|"~     The purpose of this study is to test a novel and tolerable office-based treatment method,~     sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related~     to Hereditary Hemorrhagic Telangiectasia (HHT) disease.~   "
125834|NCT01408719|"~     The primary aim of this study is to determine whether the cholesterol-lowering efficacy of~     barley b- glucan varied as function of molecular weight (MW) and the total daily amount~     consumed. Our second aim is to investigate the mechanism responsible for the action,~     specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting~     cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet~     interactions are associated with cholesterol lowering by barley β-glucan. In addition, we~     aim to investigate the alteration of the gut microbiota after β-glucan consumption and the~     correlation between the altered gut microbiota and cardiovascular disease risk factors.~   "
125835|NCT01408706|"~     The purpose of this study is to compare reproducibility of the device position and location~     of the prostate rectum interface between two immobilization devices for radiation therapy of~     prostate carcinoma.~   "
125836|NCT01408693|"~     The aim of the study is to test the hypothesis that patients older than 60 years with a~     femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior~     minimal-invasive approach as compared to a standard lateral Hardinge approach show better~     functional recovery postoperatively as measured by the Timed up and go-test (TUG).~   "
125837|NCT01408680|"~     The investigators believe that relieving the oxidative stress experienced by hemodialysis~     patients may help improve cardiovascular health.~      In this study, the investigators hypothesize that administration of coenzyme Q10, as a~     targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by~     hemodialysis patients. This will lead to improvements in biomarkers of:~        -  oxidative stress status~        -  inflammatory status~        -  endothelial dysfunction~   "
125838|NCT01408667|"~     The purpose of the study is to determine the safety and efficacy of TRC150094 in male~     patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of~     cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL~     cholesterol, insulin resistance, dysglycemia and visceral obesity.~   "
125839|NCT01408420|"~     In Denmark around 3500 procedures are conducted involving a heart-lung-machine per year. An~     increase in the prevalence of postoperative kidney insufficiency have been observed~     following these procedures, during the last years. Kidney related complications are~     associated with a higher mortality and morbidity.~      The reason and mechanisms behind this impaired kidney function is unknown. One possible~     cause could be that the blood pressure used in the heart-lung-machine is too low, during~     surgery. In the PPC trial we plan to include 100 patients. One half of the patients are~     operated with a normal, lower, blood pressure on the heart-lung-machine. The other half~     receives a blood pressure of > 60 mmHg during surgery.~      The primary goal of the trial is to measure the kidney function (GFR) the day before surgery~     compared to day 4 - 6 and 4 months (+/- 14 days) after surgery. During the surgery a~     catheter is inserted through the femoral vein into the kidney vein. This makes it possible~     to measure several biochemical markers and the oxygen consumption of the kidney, during the~     surgery. Urine samples are also collected and analyzed.~      The study hypothesis:~      The glomerular filtration rate (GFR) is better preserved after cardiac surgery with extra~     corporal circulation with an intended increased periprocedural arterial blood pressure~     compared to current practice.~   "
125840|NCT01408407|"~     The purpose of this study is to determine whether Alkagin paste is effective at preventing~     radiodermatitis in patients receiving external beam radiation therapy to the perineal area.~   "
125841|NCT01408394|"~     Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible~     diseases. To date, all clinical studies have been done using the ecopipam immediate release~     (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been~     produced that may be able to improve its effectiveness and reduce its side effects. The main~     purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules~     when given as single oral dose in healthy volunteers.~   "
125866|NCT01408069|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different associations of drugs in the treatment of patients diagnosed with tensional-type~     headache in accordance with International Headache Society guidelines.~   "
125842|NCT01408381|"~     Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group~     controlled with three levels of dose.~      The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide~     progenitor cells with regenerative capacity and besides secrete several angiogenic factors,~     and their implantation into ischemic tissues with both elements should contribute to~     angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.~   "
125843|NCT01408368|"~     The extent of thyroid resection in Graves' disease remains controversial. The aim of this~     study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total~     thyroidectomy in patients with Graves' ophthalmopathy.~   "
125844|NCT01408355|"~     To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose~     via both intravenous and oral routes.~   "
125845|NCT01408342|"~     The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and~     rituximab as first line therapy in aplastic anemia.~   "
125846|NCT01408329|"~     Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like~     device to expose users to controlled fluctuations in air pressure. It is designed to promote~     quicker altitude acclimatization, thus promoting improvements in exercise capacity at~     altitude and, possibly, at sea level. However, over the past few years, anecdotal stories~     from users of the device suggest that the CVAC treatments might be causing changes beyond~     the expected endurance exercise performance benefits. Therefore, the purpose of the study is~     to obtain data on some of the previous anecdotal claims regarding the device (e.g. increases~     in strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint~     swelling) as well as to obtain broad questionnaire data in order to identify more specific~     variables to investigate in future studies.~   "
125847|NCT01408316|"~     This is a two part study designed to evaluate the PK profile of PX-866 capsules versus~     tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy~     volunteers.~   "
125848|NCT01408303|"~     The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an~     optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol~     in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.~   "
125849|NCT01408290|"~     The purpose of this study is to determine the immunogenicity, tolerability and dose-effect~     relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent~     influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1,~     A/H3N2 and B influenza antigens in adults and elderly people.~   "
125850|NCT01408277|"~     Subjects enrolled in this study will either use Santyl daily or follow standard care~     procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the~     subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors~     will look at the wound in the office each week (up to 12 weeks) to see if the wound is~     healing. Depending on a number of factors at each office visit, the study doctors may also~     use a procedure called sharp debridement to remove dead skin from the wound.~      This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl~     will result in more rapid healing, healthier wounds, and fewer required sharp debridements~     over the study period than for diabetic foot wounds treated in other ways.~   "
125851|NCT01408264|"~     The aim of this study is to determine whether using a smaller wire results in a higher~     success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence~     of adverse events~   "
125852|NCT01408251|"~     The purpose of this study is to see if blood obtained from a vein (smaller blood vessel) can~     be used instead of blood obtained from an artery (larger blood vessel).~   "
125853|NCT01408238|"~     The objective of this study is to determine the biologic activity of a Secale cereale~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
125854|NCT01408225|"~     The investigators are researching patients with diseases of their plasma cells in order to~     improve their quality and length of life. The investigators have created a database of~     patient information, blood samples, and bone marrow tissue in order to achieve the following~     three goals:~        -  Surveillance: The investigators want to track what treatments patients get or don't~          get, how effective they are, how they feel, what complications they suffer, how long~          they stay in remission, and how long they live.~        -  Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed~          in the state of Ohio each year, patients often feel they don't have accurate~          information. The investigators want to provide them access to our clinical team (both~          phone and email consultations, even office visits for patients that can come to~          Columbus) as well as information regarding informational events pertaining to your~          disease and local support groups.~        -  Research: Because nearly all myeloma and amyloid patients relapse and treatment is~          eventually unsuccessful, our focus is to develop more effective treatments that not~          only prolong life, but cure the disease. Periodically the investigators will inform~          them about clinical trials studying new drugs or treatment paradigms.~   "
125855|NCT01408212|"~     This study aims for evaluating the effectiveness, safety and feasibility of additional~     acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient~     setting. The acupuncture therapy will be administered during a resting period between cycles~     of chemotherapy.~   "
125867|NCT01408056|"~     The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe~     and effective in promoting wound healing of infantile ulcerated hemangiomas compared with~     standard conservative management with topical antibiotic.~   "
125868|NCT01408043|"~     This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell~     mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such~     as filgrastim, and plerixafor and etoposide together helps stem cells move from the~     patient's bone marrow to the blood so they can be collected and stored.~   "
125869|NCT01408030|"~     The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal~     sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment~     of HHT related nosebleeds.~   "
125870|NCT01408004|"~     In this study will be examined whether alternating treatment between two classes of drugs~     (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal~     cancer.~   "
125856|NCT01408199|"~     Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous~     involvement at some point during course of their disease. In spite of the esthetic~     consequence during the acute phase, the main problem is still related to its disfiguring and~     incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the~     conventional therapy. Unfortunately, approximately 30% will be refractory to these measures.~     For those patients, immunosuppressive therapy can be an alternative with controversial~     results. Several series have shown a 90% of clinical efficacy in patients treated with~     Thalidomide. Unfortunately, the main drawback has been the serious described side effects~     such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide~     analogue, more potent, efficient and with better safety profile has been discovered. The~     main objective of the study is to evaluate the efficacy and safety of Lenalidomide for~     patients with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect~     of this drug on the systemic manifestations of lupus disease, the adverse effects, frequency~     of flare after withdrawal, the sequela and the effect on the seric parameters. Methods:~     Twelve patients with refractory cutaneous lupus will be included. Lenalidomide will be~     started at 5mg/day and tapered progressively. Blood test and EMG will be performed at onset~     and at the end of follow up.~   "
125857|NCT01408186|"~     Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in~     Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half~     of all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has~     contributed to about one-third of the bleeding ulcers admitted to the investigators hospital~     that serves a local population of 1.5 million.~      In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced~     bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a~     major dilemma. In another double-blind randomized trial, the investigators have shown that~     discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a~     significantly increased in mortality within 8 weeks.~      In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the~     dominant preventive strategy. Given the vast number of people taking ASA, however, it is~     only cost-effective to identify and treat those who are at high risk of ulcer bleeding and~     who have a strong indication for ASA use. Data from observational studies and randomized~     trials have consistently shown that PPIs are effective in reducing the risk of ulcer~     bleeding associated with ASA. Other potential preventive strategies include eradication of~     H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and~     co-therapy with misoprostol or H2RAs.~   "
125858|NCT01408173|"~     The aim of the present Phase III study is to evaluate the safety, efficacy and~     pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.~   "
125859|NCT01408160|"~     This phase I trial studies the side effects and the best dose of deglycosylated ricin A~     chain-conjugated anti-cluster of differentiation (CD)19/anti-CD22 immunotoxins when given~     together with cytarabine in treating patients with B-cell acute lymphoblastic leukemia that~     has come back after a period of improvement (relapsed) or does not respond to treatment~     (refractory). Immunotoxins, such as deglycosylated ricin A chain-conjugated~     anti-CD19/anti-CD22 immunotoxins, can find certain cancer cells and kill them without~     harming normal cells. Drugs used in chemotherapy, such as cytarabine, work in different ways~     to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving deglycosylated ricin A chain-conjugated~     anti-CD19/anti-CD22 immunotoxins with cytarabine may kill more cancer cells.~   "
125860|NCT01408147|"~     This study will examine the effects of an online behavioral intervention to promote weight~     loss in low income postpartum women in the WIC program.~   "
125861|NCT01408134|"~     The primary objective of this study is twofold:~        1. To define inter-reader variability of myocardial viability imaging within the first~          pass and delayed enhancement cardiac CT perfusion imaging~        2. To evaluate DE CT image quality using a consensus DECT protocol~   "
125862|NCT01408121|"~     This is a genetic and platelet reactivity study of African-American versus Caucasian~     patients undergoing percutaneous coronary intervention and receiving clopidogrel or~     prasugrel. The investigators aim is twofold: to describe differences in allele frequencies~     between African-Americans and Caucasians, and to explore associations of platelet reactivity~     and genetic polymorphisms in these two groups.~   "
125863|NCT01408108|"~     This study is prospective randomized trial enrolling at least 100 participants which~     compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for~     large (i.e. with hiatal surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to~     diameter of defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural~     repair and repair with partially absorbable lightweight mesh. According to the literature,~     rates of anatomical failure and recurrence of GERD after primary repair of large hiatal~     hernias reach 42 %. Mesh repair decreases rates of failures, however, polypropylene and~     composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia~     and oesophageal strictures. Our own experience of more than 400 repairs using partially~     absorbable lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its~     fixation precluding contact of the mesh with the oesophagus, showed low recurrence rate and~     a few cases of long-term dysphagia. Thus, final conclusions could be established by~     prospective randomized study. Our hypothesis is: original technique of lightweight mesh~     repair is highly effective for prevention of recurrences compared to primary repair and safe~     in terms of mesh-related dysphagia and oesophageal strictures. The long-term results (24~     months post surgery for every patient) will be studied using symptom questionnaires, quality~     of life and satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH~     testing, and analysis of possible reoperations.~   "
125864|NCT01408095|"~     The study is designed to see if once daily oral dosing of LY2608204 will help control~     diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will~     also help to determine the safety of the medication and the most useful doses of the~     medication.~   "
125865|NCT01408082|"~     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502~     compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects~     with Non-bacterial Blepharitis.~   "
125871|NCT01407991|"~     The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube~     placement for efficacy and safety in the placement of NG/OG tube in infants less than 6~     months of age. One method is based on the infant's length determined by measurement using a~     length board and plotted on a graph derived from a formula to determine the depth for tube~     insertion (graph method) and the other method is based on current standard of care,~     measuring from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube~     to know how far to insert the tube. Outcome comparison will be xray verification of~     placement.~   "
125872|NCT01407978|"~     This is a single-blind, reference drug controlled study to assess safety and tolerability of~     FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn~     phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents.~     To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology~     testing.~   "
125873|NCT01407965|"~     Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and~     plasma.~   "
125874|NCT01407952|"~     This research study is being done to test the effectiveness of a new generation FDA approved~     device for treating aneurysms compared to the current standard device for endovascular~     aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of~     minimally invasive surgery, which is performed on blood vessels. The technique involves the~     introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the~     skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery~     found near the groin. The catheter is then maneuvered through the body to the location of~     the aneurysm in the brain using image guidance. Coils are delivered into the aneurysm~     through the catheters. Once the coils are delivered in the aneurysm, they are detached from~     the catheter. This is repeated until enough coils fill the aneurysm, blocking the blood flow~     to the aneurysm. The body responds by forming blood clots around the coil(s), which helps~     block the flow of blood into the aneurysm and keeps the vessel from rupturing or leaking.~     This study will compare the study device to the standard bare platinum coil to see which is~     better at preventing future rupturing or leaking. The study device is called the HydroCoil~     Embolization System and this study is a post-market clinical trial.~      About 600 subjects from multiple institutions will take part in this study.~   "
125875|NCT01407939|"~     This proposal describes 2 basic research studies that will be conducted sequentially. Study~     1 will test the efficacy of both classic and newly developed generally recognized as a~     safe (GRAS) bitter blockers on the perceived bitterness and acceptance of different classes~     of bitter-tasting compounds by children and compare their responses to adults. Because~     variations among and between children and adults in terms of sensitivity to different bitter~     compounds are due in part to genetically determined receptor variation, the investigators~     will consider genotype when assessing how well bitter blockers perform. In Study 2, the~     investigators aim to evaluate different methods (forced-choice procedures, hedonic face~     scales) used for testing children to determine their reliability and reproducibility.~   "
125876|NCT01407926|"~     Objective: The objective of this study is to evaluate the feasibility, acceptability and~     effectiveness of a 6-month nurse-led, interprofessional mental health promotion intervention~     aimed at older home care clients with depressive symptoms using personal support services.~      Methods/Design: This one-group pre-test post-test study aims to recruit a total of 250~     long-stay (> 60 days) home care clients, 70 years or older, with depressive symptoms who are~     receiving personal support services through a home care program in Ontario, Canada. The~     nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that~     involves regular home visits, monthly case conferences, and evidence-based assessment and~     management of depression using an interprofessional approach. The primary outcome is the~     change in severity of depressive symptoms from baseline to 6 months using the Centre for~     Epidemiological Studies in Depression Scale. Secondary outcomes include changes in the~     prevalence of depressive symptoms and anxiety, health-related quality of life, cognitive~     function, and the rate and appropriateness of depression treatment from baseline to 12~     months. Changes in the costs of use of health services will be assessed from a societal~     perspective.~   "
125877|NCT01407913|"~     The study hypothesis is that caudal epidural steroid injections provides short term relief~     to patients with persistent low back pain and sciatica due degenerative disc disease or~     lumbar spinal stenosis. Patients will be evaluated wiht clinical examination and~     radiological examinations before injections. They will be followed up with questionnaires on~     pain and disability up to 6 months postinjection.~   "
125878|NCT01407900|"~     The overall aim is to conduct a human physiologic study to assess the renal and neurohumoral~     effects of CD-NP vs placebo in older subjects with stable chronic systolic heart failure and~     moderate renal dysfunction.~   "
125879|NCT01407887|"~     Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for~     falciparum malaria treatment in African children: randomised controlled trial.~      Design: Mono-centre, two arms, open randomized controlled study in children with~     uncomplicated falciparum malaria in Burkina Faso.~      Phase: Phase II.~      Objectives: The primary objective of this trial is to study the efficacy and safety of the~     triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three~     days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the~     local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.~      Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna~     Hospital in north-western Burkina Faso.~      Sample size: 180 patients (90 per study arm).~   "
125880|NCT01407874|"~     To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol~     in subjects with moderate renal insufficiency.~   "
125881|NCT01407861|"~     This is a single centre, open label, prospective, randomized study on the prophylactic~     effect of moderate aerobic endurance training versus relaxation training in patients with~     migraine.~   "
125882|NCT01407848|"~     In this study we will prospectively analyze the benefit of inhaled furosemide for preterm~     and term neonates with Transient Tachypnoea.~   "
125883|NCT01407835|"~     The objective of this study is to determine the biologic activity of a Dactylis glomerata~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
125884|NCT01407822|"~     Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral~     mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not~     clearly defined. Concurrent chemoradiation therapy remains an important treatment for stage~     IIIA disease, but its treatment-related life threatening toxicity limits its use. The EGFR~     tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary~     adenocarcinoma carrying EGFR activating mutations in the metastatic setting. In the OPTIMAL~     study, first-line erlotinib versus carboplatin/GEM in advanced NSCLC pts with EGFR~     activating mutations, the primary analysis showed significantly prolonged progressive free~     survival (PFS) was with erlotinib vs carboplatin/GEM (p<0.0001). The aim of this study is to~     investigate the efficacy and safety of erlotinib versus GEM plus cisplatin (GC) as~     neoadjuvant treatment in pts with stage IIIA-N2 NSCLC with EGFR activating mutations and to~     explore a new treatment strategy for this subset.~   "
125885|NCT01407809|"~     Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people,~     and is associated with headache and loss of vision. The medical and surgical management of~     IIH is problematic and many patients are not treated effectively. Some cases of IIH are~     associated with severe stenosis of the large veins of the brain and various researchers have~     recently reported significant improvement in patients with IIH after the narrow veins of the~     brain were treated with a stent. Our project aims to evaluate the safety and long-term~     efficacy of venous sinus stenting in patients with severe IIH refractory to medical~     management.~   "
125886|NCT01407796|"~     The overall purpose of this research is to gain understanding of the basic responses of the~     lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and~     involves red, warm, and often painful swelling of the affected tissue. Acute lung injury~     involves a generalized inflammation to the lung that is activated by any of several~     conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is~     severe, not enough oxygen can get into the body; this can lead to the need for mechanical~     support of breathing (mechanical ventilation), problems with brain, heart or other organ~     function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to~     the development of lung inflammation.~   "
125887|NCT01407783|"~     NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington~     University in St. Louis. This study explores the co-location of depression treatment within~     nurse home visitation and the organizational changes needed to maintain access to~     evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment~     because it is well suited for use by non-mental health specialists and for in-home~     treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.~   "
125888|NCT01407770|"~     RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy~     may cause skin reactions when patients are exposed to high-energy x rays. Studying the~     genetic pattern of patients before and after radiation therapy may help doctors prevent~     toxicity and plan the best treatment.~      PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin~     reactions in racial/ethnic groups of patients with breast cancer.~   "
125889|NCT01407757|"~     RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well~     patients will respond to treatment. It may also help doctors learn more about how gemtuzumab~     ozogamicin works in the body.~      PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from~     patients with acute myeloid leukemia treated on COG-AAML0531.~   "
125890|NCT01407744|"~     This research trial studies tumor samples from patients with ependymoma treated on the~     Children Oncology Group ACNS0121 trial. Studying samples of tumor tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors find better ways to treat~     cancer.~   "
125891|NCT01407731|"~     RATIONALE: Studying protein expression in samples of tumor tissue from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors find better ways to treat~     neuroblastoma.~      PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples~     from patients with neuroblastoma.~   "
125892|NCT01407718|"~     This project will address the incidence of anterior knee pain in the approaches used for~     tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be~     compared to the approaches in which nail insertion requires the knee to be placed in~     flexion. The incidence of anterior knee pain will be compared in each group to assess~     whether the compared approaches result in similar levels of anterior knee pain. Patients~     will be given the 2000 IKDC Subjective Knee Evaluation Form to assess anterior knee pain.~     The 2000 IKDC Subjective Knee Evaluation Form is a newer assessment tool created by the~     International Knee Documentation Committee. It has been validated for use with broad patient~     populations dealing with various knee disorders.19~   "
125893|NCT01407705|"~     The investigators propose a prospective study, designed to analyze the efficacy of~     High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in~     subjects with spinal cord injury. Study subjects will not be randomized, as treatment will~     follow the doctor's standard of care. Patients will be selected and offered enrollment~     based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease~     or trauma. Enrollment will be based on the chronology of patient presentation.~   "
125894|NCT01407692|"~     The purpose of this study is to determine if the phase of the menstrual cycle (opposed~     versus unopposed estrogen phase) affects eating behavior, including types of foods~     preferred, wanting/desire for specific foods, and perception of hunger.~   "
125895|NCT01407679|"~     To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE~     with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area~     and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks~     of treatment or at the latest assessment for patients who withdrew prematurely. Response is~     defined as a reduction of 50% in the total RCLASI compared to the baseline value (RCLASI~     50).~   "
125930|NCT01407224|"~     The aim of this operational research is to compare the cost-effectiveness of two methods for~     capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin~     to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and~     increase early exclusive breastfeeding in research areas of rural Bangladesh.~   "
125896|NCT01407666|"~     This prospective, randomized study is intended to assess the efficacy and safety of~     bilateral continuous paravertebral blocks compared to continuous epidural block for open~     liver resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in~     controlling the perioperative pain; and 2) safe, with less frequent complications following~     open liver resection when compared to continuous epidural block.~   "
125897|NCT01407653|"~     Chronic low back pain and sciatica in adults represent a major medical and economic problem.~     During the chronic back pain (persisting continuously over 3 months), therapeutic responses~     to conventional pharmacologic type are often ineffective and the impact of pain is often~     heavy in terms of disability, social and professional avulsion and loss of quality of life.~     This failure has led in recent years to propose innovative strategies such as application of~     relaxation therapy techniques. An example is a virtual reality which is a technology to~     immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion~     combined with virtual reality can be effective on chronic pain. The main purpose is to~     measure the impact on the intensity of pain at 4 months after using of a new method for~     virtual environment, mimicking the colors from low to high frequencies (World Patent Filed,~     WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to~     therapeutic drugs.~   "
125898|NCT01407640|"~     Insulin allergy (IA) is still observed even with recombinant human insulin and insulin~     analogs.~      Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses~     problems in face of IA because insulin is often vital for the patient. IA is thus a complex~     situation in which a rigorous diagnostic procedure to identify the exact allergen is~     necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a~     diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate~     immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.~   "
125899|NCT01407627|"~     Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter~     additive that can be found in everything from soda pop to yogurt to granola bars. In the~     last few years a significant number of studies have been published linking consumption of~     fructose with obesity, hypertension and more recently, kidney and cardiovascular disease.~      Animal studies show a strong link between excessive ingestion of fructose and the~     development of kidney and cardiovascular disease mediated by the renin angiotensin system, a~     hormonal system whose activation is detrimental to both the kidney and the heart. There has~     been very little research done on the potentially pathophysiological relationship between a~     high fructose diet and kidney and cardiovascular disease in humans.~      The investigators hypothesize that ingestion of fructose will result in upregulation of the~     renin angiotensin system in healthy humans.~   "
125900|NCT01407614|"~     In a prospective randomized controlled trial, the investigators aim to assess whether~     external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its~     sequelae in patients with an aneurysmal subarachnoid hemorrhage.~   "
125901|NCT01407601|"~     Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality.~     Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein~     (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on~     vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of~     vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed~     towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily~     vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins~     in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP),~     noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).~   "
125902|NCT01407588|"~     The purpose of this study is to compare manual and magnetic navigation in ablation for~     atrial fibrillation.~   "
125903|NCT01407575|"~     The purpose of this study is to compare the safety and efficacy of buprenorphine with~     placebo for adults with treatment resistant depression (TRD).~   "
125904|NCT01407562|"~     This is an open label, dose escalation study to determine the safety and tolerability and~     maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in~     patients with advanced solid tumors.~   "
125905|NCT01407549|"~     Background: Chronic pain is a common condition in the general population, causing great~     suffering in both physical and mental aspects. Previous research shows that mindfulness~     based interventions help chronic pain patients to cope better with their pain, and improve~     their quality of life. Although evidence support the efficacy of mindfulness based~     interventions for chronic pain, it is still unclear whether this efficacy involves a direct~     influence on sensory aspects of pain perception. Further more, the mechanisms of change~     responsible for the improved life quality and the possible moderating factors that may~     influence treatment efficacy, are still unknown.~      Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention~     on pain perception and quality of life in individuals suffering from chronic pain. The~     investigators will also evaluate potential mechanisms responsible for the change following~     mindfulness practice. Finally the investigators will examine the role of personal~     characteristics as potential moderating factors of mindfulness effect.~      Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group,~     chronic pain patients participating in a full mindfulness based program will report greater~     improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will~     demonstrate changes in physiological characteristics of pain. 2) Changes following the~     mindfulness based program will be mediated by change in pain catastrophizing, self~     regulation capacity and pain acceptance. 3) The investigators hypothesize that gender,~     baseline mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness~     based program.~      Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness~     based intervention on pain perception and quality of life in individuals suffering from~     chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a~     mindfulness based treatment group, or to a waitlist control group, and will be assessed for~     psychological variables and psychophysical pain assessment before treatment. Participants~     allocated to treatment group will then attend six group meetings in which they will learn~     and practice different mindfulness meditation techniques, and will be asked to practice~     these techniques on a daily basis. Post treatment assessments will take place at the end of~     the intervention for both treatment and control groups.~   "
125906|NCT01407536|"~     Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may~     facilitate cortical excitability in healthy adults. However, it is unknown whether TS can~     increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial~     magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it~     can present the cerebrum activation situation more instantaneously. This study aimed to use~     TMS examining the effect on corticomotor excitability, reorganization and functional motor~     recovery after TS on affected upper limbs of chronic stroke patients.~   "
125907|NCT01407523|"~     To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as~     adjunctive treatment in subjects with Partial Onset Seizures after switching from the~     equivalent Levetiracetam oral dose.~   "
125908|NCT01407510|"~     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat~     0.1% ointment in Japanese adults with atopic dermatitis.~   "
125909|NCT01407497|"~     While antiretroviral drugs have shown great promise in reducing HIV replication and thus in~     reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial~     and side effects are a potentially limiting factor. Development of an effective~     safe-affordable vaccine is likely to be the best way to stop further virus spread. The study~     aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg~     delivered id in combination with MVA-CMDR boost im.~   "
125910|NCT01407484|"~     BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of~     cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome~     (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases.~     Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals~     attacking the sperm cell functions.~      HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory~     male infertility, the investigators hypothesize that its treatment (as well as its possible~     cause) must restore or improve the fertilizing capacity of patients sperm.~      METHODS: This prospective randomized study will test the response to the treatment. The~     investigators shall measure cellular degradation products due to the OS, thereby certifying~     that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess~     the impact of the syndrome on the genital tract glands and follow its evolution.~      The patients will be included in the study as soon as the leukocytospermia will be >~     0,5*106/ml or as soon as the elastase will be > 500 ng/mL.~      The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen~     Analysis). The analysis of sperm morphology will be centralized.~      Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate~     that it should arrive to 20 % of the patients included in the arm treatment by~     corticosteroid therapy. All in all will thus be needed 50 patients in the group placebo and~     50 in the group treated.~      Secondary endpoint the improvement of the spermatic parameters and the reduction of the~     fragmentation of the DNA of sperm cells to the treated subjects.~      All these biological markers will be evaluated 6 month after the treatment:~        -  Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months~        -  Leukocytospermia and elastase~        -  Seminal biochemistry~        -  Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl,~          8OHd-Guanosine)~        -  Possibly the radiological examinations (Ultrasound and MRI of the genital tract)~      In addition it would allow us to propose a policy of prevention towards acquired~     post-infectious male infertility.~   "
125911|NCT01407471|"~     The purpose of this study is to determine whether spironolactone could significantly reduce~     cutaneous atrophy due to corticosteroids.~   "
125912|NCT01407458|"~     To examine the impact of a structured physical activity program focused on bone strength in~     elementary school children in the framework of their physical education classes on:~        1. Bone strength of children participating in the activity.~        2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal~          jumping strength, static balance, dynamic balance and coordination.~   "
125913|NCT01407445|"~     Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.~   "
125914|NCT01407432|"~     Unexplained male infertility is increasing, and, nowadays, the investigators only can~     propose palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a~     key for the maintenance of genome integrity. A dysfunction in this pathway can be~     responsible of spermatogenesis defects, and further, of infertility. Few assays have shown~     that folate treatment can improve sperm parameters and fertility, till 30% in some of theses~     studies. The purpose of the investigators study is to demonstrate the impact of folates~     treatment on improvement of sperm parameters and on the rate of success of in VITRO~     fertilization procedures.~   "
125915|NCT01407419|"~     The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data~     Collection Program) sites. Subjects are recruited to participate in this 12 month trial~     examining outcomes and feasibility of implementing a Treat to Target approach, when compared~     with a control group of subjects treated with usual care.~   "
125916|NCT01407406|"~     Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese~     populations to support future clinical development of BIIB023 in China and Japan.~      Study Design: This is a single-dose study to assess the PK, safety, and tolerability of~     BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy~     volunteers. The Caucasian group is included to allow comparison of PK data from different~     groups using data from the same study under the same controlled conditions.~      Subjects will be in the clinic for 48 hours around the time of dosing and in the study for~     up to 100 days.~   "
125917|NCT01407393|"~     Glucosanol™, the medical device to be investigated contains a proprietary plant extract that~     is a natural inhibitor of alpha-amylase and can reduce starch digestion.~      The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body~     weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the~     efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.~   "
125918|NCT01407380|"~     This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     clinical effects of orally administered PWT33597 mesylate in subjects with advanced~     malignancies.~   "
125919|NCT01407367|"~     Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this~     disease when they are getting medical treatment. Patients with CKD have special needs for~     their medical treatment. When these special needs are not considered their medical care may~     lead to unintended harm (called safety events) which can cause hospitalization, more kidney~     problems, and even death.~      This research study has two purposes. The first purpose is to determine how participants~     feel about wearing a medical alert bracelet or necklace that alerts health care workers that~     the user of the bracelet or necklace has decreased kidney function. Medical alert bracelets~     are often recommended for people who have other medical problems, such as diabetes. This~     medical alert bracelet or necklace has an address to an informational website about the safe~     care of patients with kidney problems. The investigators think that alerting health care~     workers that a person has decreased kidney function may decrease their chances of having a~     medical injury and improve the safety of their care.~      The second purpose of this research study is to track how often people with kidney problems~     may be exposed to medicines, tests, or procedures that might increase their chance of having~     an accidental medical injury or safety event. Though some medical injuries can not be~     prevented, the investigators want to find out what medical events in patients with kidney~     problems might be preventable. The investigators also want to find out if other things might~     increase a patient's chances of getting a medical injury, such as physical weakness or~     medical instructions that might be confusing.~   "
125931|NCT01407211|"~     The aim of this study is the comparison between the effects of supplementation with vitamin~     A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in~     multiple sclerotic patient.~   "
125920|NCT01407354|"~     Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and~     are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord~     injury, individuals are able to walk less both in their home and in their community.~     De-conditioning, or a lack of endurance and fitness also occurs. Several methods are~     available to try to improve walking ability and the fitness of persons with motor incomplete~     spinal cord injury. This study examines two of these methods. The first is the use of~     robotically assisted body-weight supported walking using a device called the Lokomat. The~     second is aquatic or pool-based exercise. The investigators are researching the impact of~     these two techniques on walking ability and fitness in people who experienced motor~     incomplete spinal cord injury for at least 12 months.~   "
125921|NCT01407341|"~     This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients~     undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone~     growth in patients undergoing surgery for spine cancer~   "
125922|NCT01407328|"~     During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the~     shoulder and trachea, compressing the upper airway. Although the extravasation is generally~     reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or~     life-threatening complications. Furthermore, the soft tissue edema around the shoulder may~     extend to the thoracic cage, compress the chest and induce the respiratory distress~     immediately after surgery. The investigators attempt to determine the effect of shoulder~     arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial~     blood gases were measured and compared before and after the shoulder arthroscopic surgery.~   "
125923|NCT01407315|"~     Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped~     with the GlucoMen®Day system, over up to 100 hours observation after implantation of the~     microdialysis probe. Different meal/hypo procedures will be performed at the study centre.~   "
125924|NCT01407302|"~     Recently, laryngeal mask airway (LMA) placements are frequently performed for general~     anesthesia. The investigators occasionally encounter a clinical situation to perform~     internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway~     in subjects undergoing major surgery. However, anatomic relations of IJV and common carotid~     artery (CCA) in patient with LMA placement have been reported to be different from those in~     patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after~     LMA placement was greater than before LMA placement. Furthermore, there are many cases of~     complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of~     puncturing CCA increases when the investigators try to cannulate IJV after LMA placement.~     Furthermore, the central landmark commonly used for IJV cannulation was proved to show low~     success rate after LMA placement in previous report.~      The investigators carefully examined the anatomic relations of IJV and CCA after LMA~     insertion with ultrasonography, and found that the degree of overlapping is different~     according to the degree of head rotation. The investigators postulated that if the degree of~     overlapping is different according to the degree of head rotation after LMA insertion, the~     investigators can find the angle of head rotation for least overlapping and reduce the risk~     of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation~     angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark~     adequate for IJV cannulation after LMA placement.~   "
125925|NCT01407289|"~     The purpose of the study is to compare the efficacy of enhanced published best practice~     paper-based insulin titration protocol for glycaemic control in hospitalised patients with~     type 2 diabetes for the length of hospital stay.~   "
125926|NCT01407276|"~     This is a 2-part study in participants with renal impairment and matched healthy~     participants to investigate the effect of impaired renal function on the plasma and urine~     levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.~   "
125927|NCT01407263|"~     This study aims to determine how different ways of performing prostate cancer surgery affect~     patient outcomes, such as recurrence of cancer or regaining control of bladder function~     (continence) after surgery. Surgery to remove the prostate is known as a radical~     prostatectomy. Surgeons know many things about the best way to do a radical prostatectomy.~     However, there is uncertainty about some methods of surgery.~      All of the surgeons who are taking part in this study have used these techniques at~     different times. However, they are unsure as to what is the best approach. This trial will~     evaluate whether the following two aspects of surgical technique influence outcome:~      Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the~     prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the~     body. However, there is uncertainty about which lymph nodes to remove (the template). In~     particular, not all surgeons think that it is important to remove a large number of lymph~     nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a~     result, these surgeons feel that removing additional lymph nodes does not improve the chance~     that a patient will be cured. In the study patients will either have the standard lymph node~     dissection or a modified approach.~      Port site incision. Some surgeries are conducted with the help of what is called a surgical~     robot, or using a laparoscopic approach (sometimes known as keyhole surgery). The~     surgeons have to make small cuts (incisions) in order to insert their surgical~     instruments. Some surgeons believe that the way in which this cut is made can affect the~     chance that a patient will develop a hernia in the months after surgery. This is when~     tissues in the abdomen protrude through the incision, creating a small bulge that has to be~     surgically corrected. In the study, patients will either have the incision made vertically~     or horizontally.~      Antibiotics. About a week after surgery, you will return to the hospital to have your~     catheter removed. To guard against the chance of infection, you will be given antibiotics.~     These do help prevent infection, but are also harmful. Doctors are unsure whether to give a~     short course of antibiotics or whether patients really need several days of treatment. In~     the study, patients will receive antibiotics for either one or three days.~   "
125928|NCT01407250|"~     Comparison of the quality of the outpatient clinic electrocardiogram performed on patients~     sent to a cardiology consultation with a standard cable and the PhysioGlove-ES~     electrocardiograms performed in the cardiology clinic.~   "
125929|NCT01407237|"~     The purpose of this study is to see if individuals with HIV-infection, particularly those~     with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis.~     Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the~     body, and they may also have effects on sugar metabolism and cardiovascular health. There is~     some evidence that individuals with HIV-associated abdominal fat accumulation may have~     increased aldosterone, which may contribute to abnormalities in sugar metabolism and~     increased cardiovascular disease seen in HIV. The purpose of this study is the measure~     renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with~     and without HIV infection, and with and without increased belly fat. The investigators~     hypothesize that aldosterone will be increased in HIV-infected individuals compared to those~     without HIV-infection, and that aldosterone will be further increased in HIV-infected~     individuals with increased abdominal fat compared to those without abdominal fat~     accumulation.~   "
125932|NCT01407198|"~     The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene~     involved in cellular growth of chordoma cells. During this research study, subjects will~     also receive radiation therapy which is considered a standard treatment for advanced~     chordomas. It is hoped by adding nilotinib, the benefits of radiation therapy can be~     enhanced without adding significant toxicities.~      The purpose of this research study is to determine the safety of nilotinib when used in~     combination with radiation therapy, and the highest dose of nilotinib that can be given~     safely with radiation therapy.~   "
125933|NCT01407185|"~     The purpose of this study is to determine the efficacy of a multi-disciplinary home program~     consisting of specific education and home-based individualized combined aerobic and~     resistance training exercise program for persons with heart failure (NYHA class II-III). The~     investigators will assess effects on endurance, gait speed, lower extremity strength,~     hospital re-admission rate and the quality of life in community-dwelling older adults from~     60 - 85 years of age over a 12 month period.~      Anticipated Results: The researchers expect confirm their hypothesis that there will be a~     statistically significant difference between the experimental group receiving the combined~     aerobic and resistance training program and the control group receiving usual care based on~     strength, endurance, quality of life, falls, and hospital re-admission data.~   "
125934|NCT01407172|"~     This will be an observational study comparing the plasma levels of free hydrogen sulfide in~     patients with and without peripheral arterial disease using a novel recently published~     method of measuring hydrogen sulfide. The investigators will also see if there is any~     difference in these levels between symptomatic and asymptomatic patients. Will examine the~     relationship of these levels to known clinical risk factors as well as plasma nitrite and~     nitric oxide levels. In doing the above the investigators hope to explore the utility of~     free hydrogen sulfide as a biomarker for peripheral arterial disease.~      Atherosclerotic peripheral arterial disease (PAD) of the lower extremities represents a~     significant and growing cause of morbidity and mortality. The PARTNERS study of screening~     ABIs in a primary care population of nearly 7000 individuals demonstrated a remarkable 29%~     incidence of ABI <0.9, which is the commonly accepted level of abnormal ABI diagnostic of~     PAD. Also of note in these patients with a new diagnosis of PAD the incidence of~     asymptomatic PAD was a striking 48%. The availability of a biomarker will greatly enhance~     the care of these patient and hopefully reduce morbidity and mortality.~      The investigators believe that hydrogen sulfide (H2S), an endogenously produced~     gasotransmitter, holds promise as a clinically useful biomarker for PAD and may also provide~     a possible explanation for the paradox of asymptomatic PAD in patients with ABIs less than~     0.9. To date, research regarding H2S has demonstrated that it participates in a myriad of~     physiological functions including vasodilatation, anti-apoptotic effects, modulation of~     mitochondrial respiration, and changes in vascular remodeling.~   "
125935|NCT01407159|"~     Cohort study according to national regulatory guidelines: Non-interventional, observational~     cohort study. Pair-matched comparison with patients chosen from historical series.~      To evaluate the clinical and technical success as well as the safety and feasibility of the~     E-XL aortic stent used in complicated type B aortic dissection in addition to a classic~     stentgraft in a single procedure.~   "
125936|NCT01407146|"~     The primary aim of this study is to increase our understanding of care-seeking behavior~     surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet~     based survey to ask individuals how they obtained medical care in the midst of a heart~     attack. At present, care-seeking delay among individuals stricken with a heart attack~     prevents them from obtaining the full therapeutic benefit of hospital based medical care in~     a timely manner to reduce the long term health consequences of a heart attack. By using a~     self-tailoring survey instrument the study attempts to take into consideration the complex~     social processes by which the individual and their family make decisions to seek medical~     care for symptoms of a heart attack. The study is designed to obtain a national sample of~     ACS care-seeking behavior in the United States.~   "
125937|NCT01407133|"~     The objective of the investigators study is to assess conventional repetitive transcranial~     magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized,~     double-blind, sham-controlled procedure, with four increasing levels of magnetic~     pseudo-dose has been designed, in order to characterize the effectiveness of rTMS while~     controlling its safety and tolerability. By combining various rTMS protocols with a~     twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the~     effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected~     benefit and the persistence of effect; (iii) assess the practical feasibility of this kind~     of therapeutic management.~   "
125938|NCT01407120|"~     The project is a 15-year follow-up of 240 young adults whose families participated in an~     experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for~     divorced families. The NBP was provided in late childhood; the follow-up occurred in young~     adulthood. Families were randomly assigned to one of three conditions: mother program (MP),~     dual-component mother and child program (MPCP), or literature-control (LC) condition.~     Programs were designed to change several putative mediators of children's post-divorce~     mental health problems using empirically-supported change strategies. The investigators~     expected that the NBP would have either main or risk by program interactive effects on~     mental health and substance use problems and disorders, developmental tasks, parent-young~     adult relationships, physical health problems, and competencies, such that YAs who~     participated in NBP will have better functioning than YAs in the control condition. The~     investigators expected that the NBP will have either main or risk by program interactive~     effects on mothers' mental health; those in the NBP are expected to have fewer mental health~     problems than those in the control condition.~   "
125939|NCT01407107|"~     The purpose of this study is to determine whether topical nitroglycerin in addition to~     5-flourouracil and radiation therapy are effective in the treatment of operable rectal~     cancer.~   "
125983|NCT01406522|"~     No medications are currently available for treatment of psychostimulant addiction, a~     compulsive preoccupation with use of cocaine and related compounds. Tacrine, a medication~     that is currently prescribed for Alzheimer's disease, can decrease the amount of cocaine~     injections that laboratory animals choose to inject by vein. This project will determine if~     tacrine can also decrease cocaine-motivated behavior for human subjects in a laboratory~     setting.~   "
125940|NCT01407094|"~     This study will examine multiple carefully selected clinical and biological markers, using~     both existing state-of-the-art technologies as well as pioneering, innovative approaches.~     The study is designed to identify moderators and mediators of treatment response for~     depression in order to specify a biosignature of treatment response for depression.~     Evaluation of the usefulness of these markers in a carefully conducted clinical trial~     comparing an antidepressant to placebo will assist in developing a Depression Treatment~     Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in~     timely selection of treatments best suited for individual patients and thus approaching~     personalized treatment. The resulting index provides a truly novel means of synthesizing the~     contribution of key clinical and biological parameters in an easy to use tool for clinical~     care.~   "
125941|NCT01407081|"~     The purpose of this study is to provide evidence for the feasibility and initial~     effectiveness of a manualized, telephone-based (telehealth) approach to the delivery of~     cognitive interventions (SMARTease) targeted to improve cognitive performance in daily~     activities after stroke.~   "
125942|NCT01407068|"~     The objectives of this study are to assess the safety and efficacy of concurrent~     administration of two injections of AA4500 into the same hand of subjects with multiple~     Dupuytren's contractures caused by palpable cords.~   "
125943|NCT01407055|"~     The purpose of this study is to evaluate the potential benefit of targeting patients'~     expectations before coronary artery bypass graft surgery through a brief psychoeducational~     intervention.~   "
125944|NCT01407042|"~     Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from~     unicompartmental knee osteoarthritis. Two different types of UKA design are available - both~     with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an~     additional amount of cartilage and bone close to the implantat. It is unclear whether this~     is of clinical relevance.~      We speculate that the amount of cartilage/bone removal is related to the clinical outcome of~     the UKA-surgery.~      In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured~     during the surgery. The clinical success of the procedure will be determined with certain~     knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months~     postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling~     around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.~      The three variables (removed amount of cartilage/bone; clinical success with regard to the~     questionnaires; bone remodelling) are then analyzed with statistical methods to find out~     potential assoziations among them.~   "
125945|NCT01407029|"~     This is a prospective, non-randomized, consecutive series, multicenter clinical study that~     will include patients who will have total hip replacement with the R3 Acetabular System.~   "
125946|NCT01407016|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     metronidazole following single and multiple intravenous infusion in healthy Japanese adult~     subjects.~   "
125947|NCT01407003|"~     This study will assess safety, tolerability, and effect of LIK066 on blood glucose in~     healthy subjects and in patients with T2DM.~   "
125948|NCT01406990|"~     The purpose of this study is to measure the percentage of women with known Coronary Artery~     Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.~   "
125949|NCT01406977|"~     The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of~     BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804.~      This study will allow a comparison of several doses of the study drug within the first two~     weeks after administration and after a longer assessment period for the highest dose level~     to enable selection of dose ranges to be tested in subsequent studies in the HPP indication.~   "
125950|NCT01406964|"~     The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for~     screening of tubal factor in patients who undergo artificial insemination.~   "
125951|NCT01406951|"~     Aims: to explore the value of TREM-1 (triggering receptor expressed on myeloid cells-1)~     ,PCT(Procalcitonin), as well as CPIS (clinical pulmonary infection score) in the diagnostic~     and prognostic assessment of VAP (ventilator associated pneumonia); and to make a comparison~     with WBC (white blood cells) and CRP (C-reactive protein) level as well as SOFA (Sequential~     Organ Failure Assessment) Score Methods: There were 92 subjects of sepsis, who were either~     receiving endotracheal intubation or had undergone tracheotomy and were exposed to~     mechanical ventilation. The subjects were divided into the VAP group (32) and the Non-VAP~     group (60), the criterion being the contraction of VAP 48 hours after ICU admission.~     Etiological culture was conducted in BALF (bronchoalveolar lavage fluid). And sTREM-1~     density was determined by examining serum sTREM-1, PCT, WBC, CRP and EVC (exhaled ventilator~     condensate). Meanwhile, the CPIS and SOFA score were worked out. With a 28-day survival as~     the demarcation line, the VAP group was further divided into the survivors group, who stayed~     alive for 28 days or more , and the non-survivors group, who died within 28 days. The~     sTREM-1 and PCT level were denoted as meridians (range interquartile), while the WBC and CRP~     level as well as the CPIS and SOFA score, means±standard deviations (SD).~      Results: Averagely, the patients would contract clinically-confirmed VAP 6.9 days after~     admission, which was mainly traced to Gram-negative bacilli infection. On the very day of~     diagnosis, compared with the Non-VAP group, the VAP group showed a higher level of serum~     sTREM-1, PCT, WBC and CRP as well as CPIS and SOFA score（295.6pg/ml vs.143.5pg/ml,~     P<0.001；4.5ng/ml vs. 1.4ng/ml，P=0.008；16.7×10∧9/L vs.10.9×10∧9/L, P<0.001；11.5mg/dl vs.~     7.7mg/dl，P=0.012； 6.0vs. 1.9, P<0.001；10.0vs. 7.5, P=0.017）, AUC (area under the receiver~     operating characteristic curve）turned out as follows :sTREM-1: 0.73（95% CI 0.61-0.85）;PCT :~     0.70（95% CI 0.57-0.83）;WBC: 0.73（95% CI 0.60-0.85）.The CPIS score, which was proved by~     logistic regression analysis as the sole risky factor to VAP, amounted to 0.96（95% CI~     0.91-1.00）. Combined prediction probability containing all the data was calculated in~     accordance on the relative regression equation. sTREM-1+WBC+CPIS score proved to be most~     reliable for diagnosis. AUC turned out as 0.98. With 0.277 as the cut-off point, sensitivity~     measured 0.97, specificity, 0.9 and YDI, 0.87. There were only 5 VAP subjects whose sTREM-1~     density could be detected in EVC. The VAP patients were divided into a survivors group~     (n=15) and a non-survivors group (n=17) with a 28-day survival as the demarcation line. The~     non-survivors group demonstrated a higher PCT level and higher CPIS & SOFA score than the~     survivors. （3.0ng/ml vs. 15.3ng/ml，P=0.032；5.4vs. 6.6, P=0.03；8.1vs.11.7 P=0.049). AUC~     worked out PCT 0.752（95% CI 0.547-0.956）and CPIS 0.764（95% CI 0.575-0.953）. Calculations on~     the regression equation showed the PCT+CPIS score was most reliable for prognostic~     assessment. AUC turned out as 0.848. With 0.516 as the demarcation line, sensitivity~     measured 0.867, specificity, 0.818 and YDI, 0.685.~      conclusion: WBC + CPIS helps improve VAP diagnosis; PCT+CPIS may be used for VAP prognostic~     assessment. Taking two items into consideration will be of guiding value in VAP treatment as~     well as mortality rate reduction. The sTREM-1 level in EVC，however，may be devoid of value~     for VAP diagnosis.~   "
125952|NCT01406938|"~     This study will assess the safety and efficacy of two different doses and two different dose~     regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic,~     plaque-type psoriasis.~   "
125953|NCT01406925|"~     This study is conducted to explore the safety and tolerability and plasma pharmacokinetics~     of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.~   "
125954|NCT01406912|"~     A multicentre, randomized, two parallel group study comparing virtual reality using Wii~     gaming technology versus Recreational activities in patients receiving conventional~     rehabilitation after an ischemic stroke.~      Primary Hypothesis: Virtual reality using the Wii gaming system is more efficacious in~     improving motor function than recreational therapy among patients receiving conventional~     rehabilitation following a recent ischemic stroke.~   "
125955|NCT01406899|"~     In this behavioral trial 80 substance abusing individuals will be randomly assigned to~     either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR~     treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a~     period of 8 weeks. Primary outcomes will be retention in treatment and reduction in~     substance use (percent days abstinent, confirmed by urine toxicology screens). The patients'~     ability to demonstrate coping skills through a computerized role-play evaluation will be a~     secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of~     effects.~   "
125956|NCT01406886|"~     This study will examine the independent and combined effects of energy density and eating~     rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy~     intake are expected to additively increase energy intake.~   "
125957|NCT01406873|"~     The purpose of this study is to investigate the effects of mexiletine treatment for 6 months~     on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,~     cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).~   "
125958|NCT01406860|"~     The purpose of this study is to determine if droperidol is equally as effective as~     metoclopramide for treatment of primary headaches in the Emergency Department.~   "
126023|NCT01406002|"~     The primary objective of this study is to determine the effect of rifampicin on the way the~     body handles darexaban and its metabolites (drug degradation products). The secondary~     objective of the study is to evaluate the safety and tolerability of a single dose of~     darexaban alone and when administered together with rifampicin.~   "
125959|NCT01406847|"~     Body-based interventions have consistently shown clinical effectiveness in patients with~     back pain. The primary objective for this study is to compare the effect of body-based~     interventions commonly used in the management of low back pain on behavioral and cortical~     measures of pain sensitivity and central sensitization of pain. Participants will be~     randomly assigned to receive one of the interventions or be in a control group. The central~     hypothesis for this proposal is that spinal manipulation, a specific form of body-based~     intervention, inhibits central sensitization of pain normalizing pain sensitivity more~     rapidly than other interventions. The completion of the proposed study will elucidate~     underpinning mechanisms of body-based interventions. Identification of these mechanisms will~     improve the clinical application and utilization of these interventions in the management of~     musculoskeletal pain conditions, especially back pain.~   "
125960|NCT01406834|"~     The goal of this project is to test the feasibility, acceptability, and efficacy of a~     treatment module addressing the mental health and functional impact of killing in the war~     zone.~      The investigators will enroll between 12-20 Veterans who have killed in war and have been~     diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the~     efficacy of the six-session treatment. Veterans will be randomized either to the treatment~     or to the waitlist control group.~   "
125961|NCT01406821|"~     Platelet rich plasma has been used in previous studies to stimulate faster healing of torn~     ligaments and tendons in order to help reduce pain and restore normal function. This study~     aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries~     with platelet rich plasma will reduce the time needed for participants to heal these~     injuries and restore function.~      We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.~   "
125962|NCT01406808|"~     The purpose of this study is to see if providing information to a person on their inherited~     (genetic) risk of cardiovascular disease (CVD) helps to motivate that person to change their~     diet, lifestyle or medication regimen to alter their risk.~   "
125963|NCT01406795|"~     To study the safety and efficacy of drug coated stents for the treatment of venous~     occlusions and stenoses in the lower extremity. The use of the device for the treatment of~     peripheral arterial disease is approved by the FDA, however, the use of the device in venous~     occlusions and stenoses, although performed by some practitioners, has not yet been studied~     in detail.~   "
125964|NCT01406782|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying DNA isolated from blood samples to see how well it~     influences response to rituximab in patients with follicular lymphoma treated on clinical~     trial ECOG-E4402.~   "
125965|NCT01406769|"~     This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity~     lymphedema in patients with stage I, stage II, stage III, or stage IV vulvar cancer~     undergoing surgery and lymphadenectomy. Diagnostic procedures, such as bioimpedance~     spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in~     patients with vulvar cancer undergoing surgery.~   "
125966|NCT01406743|"~     The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or~     radiography, determining the lumbar pain cause and gravity, to propose a conservative~     treatment in first intention or a adapted spine surgery in first or second intention~     (Fritzell and al ., on 2001).~      The analysis and the correction of postural disorders pass inevitably by a good knowledge of~     the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by~     EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.~      However, the EOS technology ™ is recent and few data were acquired with this technology for~     healthy population.~      So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of~     the standing skeleton in position (to an asymptomatic adult population), by displaying the~     gravity constraints on the joints, and the compensation phenomena in normal situation. This~     functional information for a given age bracket would allow to propose to the patients with~     lumbar pain, adapted interventions to the gravity constraints considering the skeleton~     evolution for age bracket.~   "
125967|NCT01406730|"~     The purpose of the study is to determine the effect of 16 weeks of running exercise on~     various parameters related to heart, vascular systems, blood, and muscle in untrained males~     30-50 years old.~      Further, the investigators assess which of the above mentioned parameters may explain the~     increase of running performance most accurate.~   "
125968|NCT01406717|"~     SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in~     reducing blood glucose levels. The purpose of study is to establish safety and efficacy of~     SPIL1033~   "
125969|NCT01406704|"~     This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic~     acid, antioxidant on patients with pathologically proved NASH (non-alcoholic~     steato-hepatitis).~   "
125970|NCT01406691|"~     Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and~     manifests as a difficulty in waking up in the morning, going to sleep early enough at night,~     and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this~     study is to determine if brief flashes of light, that are scheduled to occur during sleep,~     are effective in treating DSPD.~   "
125971|NCT01406678|"~     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion~     reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG)~     surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The~     present study assesses protection of heart, brain and kidney by RIPC under crystalloid~     cardioplegic arrest. The study also addresses safety and clinical outcome.~   "
126024|NCT01405989|"~     The primary objective of this study is to determine the effect of ketoconazole on the blood~     concentrations of darexaban and its metabolites (drug degradation products). The secondary~     objective of the study is to evaluate the safety and tolerability of a single dose of~     darexaban alone and when administered together with ketoconazole.~   "
126290|NCT01402518|"~     This is a prospective chart review/data collection study of the per oral endoscopic myotomy~     (POEM) procedure, that will include questionnaires administered throughout the study.~     Subjects enrolled will be those intending to have a POEM procedure. Data will be collected~     and reviewed through 12 months post-op.~   "
125972|NCT01406665|"~     Early detection of (pre)diabetes, including impaired glucose tolerance is currently~     deficient because the best accepted standard, an oral glucose tolerance test (oGTT), is not~     feasible in a setting of screening or broad case-finding and other current methods lack in~     sensitivity. A previously reported study, and analysis of retrospective skin~     autofluorescence (AF) data, suggests that noninvasive skin AF may offer an alternative for~     detection of (pre)diabetes. The objective is to test the validity of a decision tree based~     on skin autofluorescence, and some simple clinical characteristics, as a detection tool for~     diabetes and impaired glucose tolerance. Sensitivity and specificity, positive and negative~     predictive value of this skin AF based decision model will be compared to those of fasting~     plasma glucose (FPG), glycated haemoglobin (HbA1c), and to two short questionnaires (Finnish~     Findrisk, and Cambridge score).~      Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed~     in at least 120 persons with the characteristics described in the following paragraph. A~     Findrisk and Cambridge questionnaire will also be collected.~   "
125973|NCT01406652|"~     Th study investigates prospectively the cost-savings related to a one-stage bursectomy~     (debridement, drainage and closure at the same time) versus two-stage bursectomy~     (debridement, left open and closure at a second time) of severe bursitis among hospitalized~     patients for surgical treatment of septic bursitis.~      We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated~     with a significant shortening of hospital stay, consumption of resources and increased~     patient satisfaction.~   "
125974|NCT01406639|"~     This study is for patients with recurrent epistaxis (nosebleeds) as a result of Hereditary~     Hemorrhagic Telangiectasia (HHT). The aim is to determine if ranibizumab, topically applied~     will diminish epistaxis in patients with HHT as measured by the HHT Epistaxis Severity Score~     (ESS), hematocrit, and hemoglobin and serum ferritin levels.~   "
125975|NCT01406626|"~     This study will implement a health navigation intervention to improve linkage to and~     retention in HIV care for inmates released from L.A. county jail into the community.~   "
125976|NCT01406613|"~     This is a 2year observational study that will recruit patients who have previously completed~     a randomised, open label, parallel, single centre study (TRIO Study) of three~     bisphosphonates: alendronate, ibandronate and risedronate. These drugs are the most commonly~     used group of treatments for postmenopausal osteoporosis in the UK. However, the length of~     time for which these treatments continue to work after they are stopped has not been fully~     elucidated. Without this information it is unclear as to how long doctors should treat and~     whether it would be good practice to give drug 'holidays'.~      The investigators plan to compare the effects on bone quantity and quality of stopping these~     licensed bisphosphonates in patients who have taken the medication for a duration of two~     years. The investigators aim to recruit up to 100 postmenopausal and up to 100 premenopausal~     (reference range) subjects. Measurements collected at the final visit of the previous study~     will be used for 'baseline' values for this study.~      The postmenopausal group will have an initial study visit to secure informed consent, and~     then further study visits at 24, 48, 72 and 96 weeks after stopping medication. Visit~     procedures will include:~      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the~     spine, hip, whole body, forearm Dual-emission X-ray absorptiometry (DXA), and heel dual~     X-ray and Laser (DXL) Quantitative Ultrasound of Bone (QUS) Vertebral Fracture Assessment~     (VFA).~      The premenopausal group will have one study visit, 96 weeks after completing the previous~     study. Visit procedures will include:~      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the~     spine and hip (DXA)~      A subgroup of 50 premenopausal women will also have the following measurements:~      Bone Mineral Density of the whole body, forearm (DXA), and heel (DXL) Quantitative~     Ultrasound of Bone (QUS).~   "
125977|NCT01406600|"~     Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from~     genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte~     maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been~     investigated about its safety and efficacy comparing with urinary hCG, but still the optimal~     dose of rhCG is questionable. From former studies, there only have been proven that high~     dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the~     other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor~     responders who cannot easily provoke OHSS. Hence, this study will assess the comparative~     efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.~   "
125978|NCT01406587|"~     PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center,~     randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of~     symptoms associated with uncomplicated urinary tract infection. After the screening,~     patients are randomized to receive one of three doses of PP4001 or placebo. Patients are~     screened and randomized on the same day, and take 4 doses of study drug, one dose every 12~     hours. Data about uncomplicated urinary tract infection symptoms are collected from the~     subjects on electronic handheld devices throughout the 48-hour study period. The primary~     endpoint is burning during urination.~   "
125979|NCT01406574|"~     The purpose of this study is:~      Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate~     the efficacy~   "
125980|NCT01406561|"~     The purpose of this study is to assess the effect of OMS103HP solution for Injection~     (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS)~     Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms~     in subjects undergoing meniscectomy.~   "
125981|NCT01406548|"~     This study is designed to provide information on the safety, tolerability, pharmacokinetics~     (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing~     regimens. This information will permit a comparison of the possible risks and benefits of~     different dosing regimens of the study drug to enable optimal doses and dose intervals to be~     tested in subsequent studies.~   "
125982|NCT01406535|"~     The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5~     inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with~     therapy refractory myocardial ischemia due to coronary artery disease judged to be~     unsuitable for surgical or percutaneous revascularisation. For proof of efficacy the~     following tests will be performed at baseline and one day and 4 weeks after discontinuation~     of therapy: Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests~     will be performed to evaluate markers of angiogenesis (endothelial progenitor cells,~     vascular endothelial growth factor, basic fibroblast growth factor). The improvement of~     myocardial perfusion will be tested functionally as increase of coronary flow reserve by~     positron emission tomography. Moreover, changes in ventricular function, symptoms and~     quality of life will be assessed.~   "
126037|NCT01405820|"~     The primary objective of this study is to explore the effects of multiple regimens of~     natalizumab on disease activity and safety in participants with relapsing-remitting Multiple~     Sclerosis (RRMS).~   "
125984|NCT01406509|"~     Haemophilus influenzae is an important pathogen which can cause primary infection and~     respiratory viral infection in infants and leaded to secondary infections. The infection of~     haemophilus is a major cause of morbidity and mortality in infants and children. At present,~     the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children~     will produce antibody of protection after 3 doses. Because Hib vaccine can prevent~     meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib~     bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal~     immune programming.~      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent~     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus~     polysaccharide vaccine with a relatively poor immune response in the infants under the age~     of two, and the remaining 60% with a low antibody level and a short duration.~      According to the present immunization schedule, to reach the median level of antibody levels~     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,~     to provide high levels of long-term protection and to reduce the number of injections.~      The objective of this study is to evaluate the safety of the group A, C polysaccharide~     meningococcal and type b haemophilus Influenzal Conjugate vaccine.~   "
125985|NCT01406496|"~     Post-meal glucose excursions may contribute to the development of diabetes-related~     complications. These glucose excursions are affected by the food content of the meal and the~     timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin~     bolus (by pump) is controversial.~      The aim of the study is to examine three different timings of insulin bolus in three types~     of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+~     fat. The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring~     system. The results obtained in the diabetic patients will be compared to those obtained in~     a group of healthy individuals that will consume similar meals.~   "
125986|NCT01406483|"~     The primary objective of this exploratory cohort study is to describe levels of platelet~     reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).~   "
125987|NCT01406470|"~     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune~     Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.~   "
125988|NCT01406457|"~     The goal in this research is to develop better ways to detect and treat the damage caused by~     bleeding in the brain.~   "
125989|NCT01406444|"~     Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in~     bone density). A significant decrease in bone density is called osteopenia or osteoporosis.~     Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the~     bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have~     this condition often have thin or weak bones that are more likely to break. They also have~     very low levels of a chemical called IGF-1 in their body. This chemical is very important~     for increasing bone growth in puberty and for maintaining healthy adult bones. The~     investigators would like to find out if giving rhIGF-1 followed by risedronate or~     risedronate alone can lead to an increase in bone formation, bone density, and bone strength~     in women with anorexia nervosa.~   "
125990|NCT01406431|"~     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan~     co-administration and Livalo fixed combination drug in healthy male subjects.~   "
125991|NCT01406418|"~     The purpose of this study is to assess in healthy subjects the safety, tolerability,~     pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal~     antibody against influenza A viruses.~   "
125992|NCT01406405|"~     Purpose The primary purpose of this study is to prospectively compare clinical and~     radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions~     and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.~   "
125993|NCT01406392|"~     The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol~     12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term~     fetus.~   "
125994|NCT01406379|"~     Although endoscopic colonic polypectomy has been an established procedure for two decades,~     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the~     presence of a large artery in the stalk. Several preventive methods such as detachable snare~     and adrenaline injection have been proposed in the management of postpolypectomy bleeding in~     large colonic polyps. For prophylactic clip, there was no prospective randomized study~     assessing the efficacy in the prevention of postpolypectomy bleeding for the large~     pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy~     of application of prophylactic clip and detachable snare in the prevention of~     postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as~     effective and safe method as detachable snare in the prevention of postpolypectomy bleeding~     for the large pedunculated colonic polyps.~   "
125995|NCT01406366|"~     Pediatricians serve an important role in promoting health in families. Bright Futures offers~     a child and family-centered approach to health promotion in incorporating partnership and~     communication skills of providers. Two areas of importance are in promotion of oral health~     and prevention of iron deficiency. We plan to study implementing educational curriculum to~     pediatric residents through a randomized controlled trial. Randomization will be done~     through assignment at the level of pediatric training program. Residents randomized to Group~     1 will receive education about Bright Futures partnership and communication skills with oral~     health as the main health promotion topic. Group 2 will receive educational curriculum~     pertaining to the topic of iron deficiency prevention. While pediatricians are positioned~     perfectly to partner and effectively communicate with families on these two issues, there~     are gaps in pediatric education addressing these topics. The CORNET continuity practices of~     the Ambulatory Pediatric Association provide a venue through which multiple residency~     programs that educate pediatric residents and whose residents provide medical care to~     underserved children can participate. The research hypotheses include:~        1. Residents in Group 1 will have greater confidence, knowledge and competence in~          partnership building and communication with families~        2. Residents in Group 1 will have greater knowledge and competence in discussing oral~          health promotion~        3. Residents in Group 2 will have greater knowledge and competence in discussing iron~          deficiency prevention~        4. Parent-child dyads in Group 1 will be more likely to have established a dental home~        5. Parent-child dyads in Group 1 will be more likely to be satisfied with their healthcare~          encounter.~      Pediatric practices provide fertile ground for the provision of health promotion on oral~     health and iron deficiency prevention. However, evidence for the effectiveness of primary~     care clinician interventions of screening, referral and counseling to prevent dental caries~     is lacking [14]. The National Survey of America's Families [15] found 47% of children did~     not receive the recommended number of dental visits, with the youngest ones being least~     likely to receive any dental care.~      Although 90% of pediatricians agreed they had important roles in identifying and counseling~     patients on prevention of caries, half stated they had received no previous training during~     medical school or residency and their knowledge of basic oral health topics was limited~     [13]. These studies highlight that pediatricians play important roles in oral health and are~     capable of being trained to complete oral screening exams, but more education and guidance~     is needed.~      Iron deficiency is the most common childhood nutritional deficiency in the United States.~     Recent prevalence data have determined that 7-30% of children in the United States aged 1-2~     years have iron deficiency and 3-10% have iron deficiency anemia [17, 18]. Specific goals in~     Health People 2010 include a reduction of iron deficiency to 5% in children less than 3~     years of age.~   "
125996|NCT01406353|"~     Although percutaneous mitral commissurotomy (PMC) has been accepted as an effective~     treatment for symptomatic patients with moderate or severe mitral stenosis (MS), most~     asymptomatic patients are not candidates for PMC owing to the small but inherent~     procedure-related risks. Asymptomatic patients with MS show good survival rates up to 10~     years, but there was a sudden deterioration precipitated by atrial fibrillation or embolism~     in half of the patients. Because the success rates of PMC were improved to more than 95% in~     ideal patients from highly selected centers and early PMC may decrease the occurrence of~     adverse events, such as atrial fibrillation or embolism, experienced centers tend to perform~     PMC at an early stage of disease. However, the potential benefits of early preemptive PMC in~     asymptomatic patients should be balanced against the real risks related to the procedure,~     and further studies of the efficacy of PMC in the prevention of embolism are necessary to~     extend its indications to asymptomatic patients. To the best of our knowledge, No randomized~     trials have been performed to ascertain the optimal timing of intervention in asymptomatic~     patients with significant MS. The early percutaneous MITral Intervention versus conventional~     manaGement in Asymptomatic moderate miTral stEnosis (MITIGATE) trial was designed to compare~     clinical outcomes of early intervention with those of a conventional management based on~     current guidelines in asymptomatic moderate mitral stenosis.~   "
125997|NCT01406340|"~     This will be an open-label, parallel-group study to evaluate the pharmacokinetics of~     GSK1278863 and metabolites in normal subjects and subjects with impaired renal function,~     including those who are hemodialysis dependent. GSK1278863 will be administered once daily~     for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15~     days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on~     Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14~     and 15 (dialysis and non-dialysis days; Stage 5).~   "
125998|NCT01406327|"~     The objective of this post-marketing surveillance study is to evaluate the incidence of~     adverse events in Japanese subjects with pulmonary arterial hypertension treated with~     ambrisentan basd on prescribing information under the conditions of general clinical~     practice and also to grasp the following items;~        1. Unknown adverse drug reactions (ADRs)~        2. Incidence of ADRs to medical products in actual clinical practice~        3. Factors influencing safety of ambrisentan~        4. Factors influencing efficacy of ambrisentan~        5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use~          (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)~   "
125999|NCT01406314|"~     This study aims to provide safety information on the ligand, GSK2315698A. The~     pharmacokinetics and pharmacodynamics of the ligand will be determined together with the~     differences in routes of dose administration, namely the tolerability between intravenous~     versus subcutaneous dose administration. The study will be carried out in patients with~     systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid~     protein (SAP) will be measured.~   "
126000|NCT01406301|"~     Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by~     Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients,~     fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI~     (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are~     managed with thrombolytics or who are initially to receive no other form of reperfusion~     therapy. The approved prescribing information for fondaparinux in ACS provides~     recommendations for use in patients undergoing PCI. The purpose of this study is to evaluate~     physician adherence to this prescribing information in ACS patients treated with~     fondaparinux and who undergo PCI. The primary endpoint is the proportion of patients with~     ACS treated with fondaparinux, for whom the prescribing information during PCI was followed~     (i.e., adjunctive anticoagulant therapy administered at the time of PCI). Measurement of the~     effectiveness or safety of fondaparinux use in ACS patients is not within the scope of this~     study.~      ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.~   "
126001|NCT01406288|"~     The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection~     with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An~     outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons~     on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).~      At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli~     of the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by~     its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e.~     the kidneys, brain, liver, pancreas, and skin.~      Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in~     adults who are usually not involved in typical E. coli O157H7 HUS.~      The aim of the present study is to gain knowledge on these different aspects of the HUS,~     including response to therapy.~   "
126002|NCT01406275|"~     This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the~     information on proper use, such as safety and efficacy, under actual use conditions,~     targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin~     infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis,~     tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.~      (CLAVAMOX is a trademark of the GlaxoSmithKline group of companies.)~   "
126003|NCT01406262|"~     This study is designed to investigate the effect of treatment with albiglutide on the~     cardiac repolarization (corrected QT interval) in healthy male and female subjects.~     Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate~     the ability of the study to detect a change in the corrected QT interval.~   "
126004|NCT01406249|"~     The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line~     treatment of Advanced Gastric Cancer.~   "
126038|NCT01405807|"~     Overview:~      This open label, randomized, multi-centre study will enroll and treat 24 patients with~     refractory AAV.~      Aims:~      To determine the clinical response and severe adverse event rates associated with~     alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis~     (AAV).~      Hypothesis:~      Treatment with alemtuzumab induces sustained remission in AAV and will reduce~     immunosuppressive and steroid exposure.~   "
126039|NCT01405794|"~     The investigators propose to study oral commercial silver nanoparticle products on human~     enzyme activity.~   "
126005|NCT01406236|"~     The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI,~     transradial PCI will result in a significant reduction in bleeding and vascular~     complications. The primary objective is to compare the efficacy and feasibility of the~     transradial approach to percutaneous coronary intervention (PCI) in women compared with the~     transfemoral approach.~      This study is a multicenter, randomized, open-label active controlled study. Three thousand~     women undergoing urgent or elective PCI from at least 50 centers will be randomized to~     either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc~     PCI will be randomized before diagnostic angiography. A total of approximately 3000 women~     will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.~      The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our~     trial is very low, making it unlikely that there will be statistical power to show a~     difference between the randomized arms in the SAFE PCI for Women study using the BARC~     bleeding definition per protocol. Based on this statistical futility, the DSMB has~     recommended stopping enrollment. They also noted, however, that as this is not based on any~     safety issues, and since there are a variety of key secondary endpoints (contrast and~     radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB~     left it to the discretion of the Steering Committee to continue enrollment to meet~     sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss~     these issues and voted to continue enrollment until the planned sample size for the Quality~     of Life substudy was met (300 patients).~   "
126006|NCT01406223|"~     The purpose of this study is to look at brain function in order to understand how different~     treatments work to help people quit smoking. In this study, the investigators will look at~     the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.~   "
126007|NCT01406210|"~     The purpose of the prospective study is to collect information surrounding lung transplant~     in order to develop a randomized study to determine if prevention of gastroesophageal reflux~     disease (GERD) related aspiration (stomach acid coming up from the stomach into the~     esophagus) by surgical fundoplication improves lung rejection. Lung transplantation has~     evolved into an effective treatment for patients with end-stage lung disease; however, a~     significant limitation to long-term survival is patients develop a condition of scarring~     known as chronic lung rejection, which can cause lung function to deteriorate, thereby~     reducing a patient's chances for survival. Preliminary research has shown a correlation~     between the presence of gastroesophageal reflux disease (GERD) and impaired early lung~     rejection as assessed by a breathing test, FEV1 (the amount of forced expired air volume in~     1 second).~      The Investigator is interested in learning more about this condition and the potential for~     aspiration (inhaling fluid) injury. The primary goal of this preliminary study will be to~     identify aspiration markers that are correlated with adverse clinical outcomes (increased~     early rejection, decreased FEV1) that may be used as inclusion criteria for the future~     randomized trial.~      The purpose of the retrospective study is to collect information surrounding lung transplant~     in order to develop a randomized study to determine if prevention of gastroesophageal reflux~     disease (GERD) related aspiration (stomach acid coming up from the stomach into the~     esophagus) by surgical fundoplication improves lung rejection.~      The goal of this retrospective data collection is to review the following:~        1. subject outcome event rates for subjects with and without gastroesophageal reflux~          disease (GERD) for survival, Bronchiolitis Obliterans Syndrome (BOS), acute rejection~          and Forced Expiratory Volume in the first second (FEV-1),~        2. the estimated treatment effect of fundoplication on the above event rates,~        3. a threshold effect for Bronchiolitis Obliterans Syndrome (BOS) and/or death are more~          likely to occur at higher or more proximal acid or non-acid contact times.~      This data will be collected in order to better design and coordinate a multicenter~     prospective study.~   "
126008|NCT01406197|"~     This study will examine the effects of various formulations of progesterone on uterine~     electromyographic (EMG) activity in pregnant patients in premature labor to determine if~     progesterone will suppress uterine electrical activity and which formulation may be best for~     inhibition of uterine activity. Patients will be monitored prior to treatment and following~     treatment (every 2 to 4 hours) with one of three different formulations of progesterone for~     up to two days. Patients will continue to be observed until they deliver. Comparisons will~     be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8,~     12 24 and 48 hours and times of delivery after treatments (hours or days following~     treatments). Comparisons between mean values for EMG activity between the various treatments~     at the various times will also be made.~   "
126009|NCT01406184|"~     The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms~     of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child~     maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting~     program that is designed to prevent child maltreatment in an entire community population.~      Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham~     Connects Program will be associated with lower rates of child maltreatment and emergency~     department maltreatment-related injuries, better pediatric care, better parental~     functioning, and better child well-being than assignment as control; 2) Intervention effect~     sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced~     family functioning will mediate the positive impact of Durham Connects on outcomes.~   "
126010|NCT01406171|"~     The purpose of this study is to determine the effect of isavuconazole at steady state on the~     pharmacokinetics of midazolam in healthy adult subjects.~   "
126011|NCT01406158|"~     A study in healthy volunteers comparing two different liquid formulations of solifenacin~     with each other and with the tablet formulation.~   "
126012|NCT01406145|"~     This study is intended to determine the safety and tolerability of ASP0777 in subjects with~     Alzheimer's Disease (AD) taking a stable dose of donepezil.~   "
126013|NCT01406132|"~     The objective of this study is to evaluate pharmacokinetics, in particular the routes of~     excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled~     ASP015K.~   "
126014|NCT01406119|"~     This is an extension study of ABT-806 for subjects with advanced solid tumors.~   "
126040|NCT01405781|"~     The objective of this study is twofold: First, to determine whether higher levels of~     pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff~     repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function,~     Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score),~     physically examine and perform a radiographic analysis of patients at a minimum of 6 months~     after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic~     scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator~     cuff repair.~   "
126041|NCT01405768|"~     Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for~     their cervical block will experience less injection pain than women who receive plain~     lidocaine.~   "
126291|NCT01402505|"~     This is a prospective chart review/data collection study of natural orifice translumenal~     endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires~     administered throughout the study. Subjects enrolled will be those intending to have a~     transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months~     post-op.~   "
126015|NCT01406106|"~     Background information Studies have been conducted on supplementing the daily diet with~     plant sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and,~     consequently, cardiovascular risk. However, clinical practice guidelines on~     hypercholesterolaemia state that there is not sufficient evidence to recommend their use in~     subjects with hypercholesterolaemia. The null hypothesis establishes that there is no~     relationship between the decrease in blood LDL-cholesterol levels and the consumption of~     stanol ester enriched liquid yoghurt. The alternative hypothesis establishes a relationship~     between such consumption and the incidence of the primary variable.~      The main objective of this study is to determine the efficacy of the intake of 2 g of plant~     sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with~     hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily~     intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and~     cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of~     adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that~     determine a greater reduction in lipid levels in subjects receiving plant sterol ester~     supplements.~      Study design Randomised, double-blind, placebo controlled experimental trial carried out at~     family doctors' surgeries at three health centres in the Health Area of Albacete (Spain).~     The study subjects will be adults diagnosed with limit or defined hypercholesterolaemia~     and who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of~     liquid yoghurt containing 2 g of plant sterol ester per container will be administered daily~     after the main meal, for a period of 24 months. The control group will receive a daily unit~     of yogurt not supplemented with plant sterol esters that has a similar appearance to the~     enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and~     24 months. The secondary variables are: change in cardiovascular risk, adherence to the~     dairy product, adverse effects, adherence to dietary recommendations, frequency of food~     consumption, basic physical examination data, health problems, lipid-lowering medication,~     physical activity, smoking habits and socio-demographic variables.~   "
126016|NCT01406093|"~     A timing diagnosis of candidemia is as important as the correct choice of empiric or~     targeted antifungal therapy. In the last years a growing body of knowledge has better~     characterized health-care associated (HCA) infections, which have been described in 2002 in~     outpatients with MRSA bloodstream infections. So far there is no compelling evidence that~     patients with HCA infections may develop candidemia before the usual timing of around 20-25~     days after admission. Risk factors associated with HCA infections are represented by~     admission from long term chronic care facilities (LTCF), haemodialysis, previous admission~     or parenteral broad spectrum antibiotics. There are few data HCA features and early onset~     candidemias in the published literature.~      In this proposal, the investigators aim at studying early-onset candidemia in a~     retrospective study in one of the largest referral hospital in Italy with a consistent range~     of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed~     patients, ICU, complex surgery). The investigators speculate that patients with candidemia~     diagnosed within 10 days (early-onset) by the admission have different risk factors and~     prognosis of those with a late diagnosis.~   "
126017|NCT01406080|"~     The purpose of this study is to:~        1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream~          0.05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale~          evaluation, investigator evaluation of global response to treatment and subject's~          evaluation of improvement.~        2. Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin~          Emollient cream 0.05% during 24 weeks of treatment.~      The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin~     Emollient cream 0.05% in the treatment of cutaneous photoaging.~   "
126018|NCT01406067|"~     The efficacy of the Treatment Program for Children with Aggressive Behaviour~     (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence~     training delivered in an individual format will be evaluated in a randomized controlled~     trial with children aged 6 to 12 years with peer-related aggressive behaviour.~   "
126019|NCT01406054|"~     Sports-related injuries are a serious concern for physically active children and~     adolescents. Previous research, including ours at Chicago public high schools, shows our~     neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces~     sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied~     in males or younger age groups. This project aims to determine KIPP's effect on~     sports-related injuries and physical fitness among 5th-8th grade students in Chicago public~     schools. The study will take place during the 2011-2013 school years. To measure KIPP's~     effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes,~     randomize coaches by school into two groups, then train the intervention group to implement~     a 10-minute KIPP warm-up before practices and games. Control group will perform their usual~     warm-up. Research assistants will collect athlete participation and injury data from coaches~     weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we~     will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks,~     and record students' presidential fitness test scores before and after the 10+ weeks.~     Results of this study will guide strategies for preventing sports-related injuries and~     improving physical fitness in 5th -8th graders.~   "
126020|NCT01406041|"~     The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical~     process of patients suffered sellar lesions. Moreover, if the patients are undergone the~     surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and~     hyper-natremia is the most common electrolyte disorder, which is directly correlated to the~     patients' outcome. However, in clinical works, different sellar diseases cause variant~     features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and~     hypernatremia always happen alternatively even without any precursor manifestation. Under~     this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will~     cause poor outcome, even death. So it is necessary to systematically collect and review the~     clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar~     diseases, more precise strategy for clinical fluid replacement will be proposed.~   "
126021|NCT01406028|"~     In vitro fertilization for infertility has been associated with a significant amount of~     treatment related stress for patients. In addition,stress levels increase between embryo~     transfer and pregnancy test, during this waiting period. The investigators evaluated whether~     or not brief interventions by phone by trained social workers influenced stress levels. Our~     data showed that these interventions did not change levels, but confirmed that stress did~     increase during this time and that patients report wanting additional emotional support to~     improve stress during this period.~   "
126022|NCT01406015|"~     The purpose of this study is to find out if spironolactone, a drug that blocks the action of~     aldosterone, can make the blood vessels work better in people with obesity. The~     investigators also want to find out whether spironolactone causes changes in levels of~     insulin and markers of inflammation.~   "
126054|NCT01405599|"~     Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a~     single intravenous (IV) dose in order to identify potential patients at risks in terms of~     severity of hepatic dysfunction and to determine whether their dosage should be adjusted.~   "
126025|NCT01405976|"~     Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus~     continuous positive airway pressure (CPAP) and the historic treatment (weight loss and~     oxygen) in Obesity Hipoventilation Syndrome (OHS), with PCO2 and days of hospitalization~     analyzed as a primary variables and percentage of dropouts for medical reasons and mortality~     as operative variables. As secondary variables: Measure functional and clinical improvement~     during sleep and wakefulness, quality of life, and the incidence and evolution of~     cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular~     inflammation, endothelial damage and the genesis of diurnal hypercapnia.~     Methods:prospective, randomized controlled trial. Patients with OHS will be divided~     initially into two groups based on their apnea-hypopnea index (AHI) score, >=30 and < 30,~     using conventional polysomnography. The AHI >=30 group will be randomized to CPAP, NIV or~     historic treatment. The AHI <=30 groups will be randomized to NIV or historic treatments.~     Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The~     role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be~     analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders~     to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The~     role of apneic events in metabolic and biochemical alterations and endothelial dysfunction~     will be analyzed by comparing basal and post-treatment levels of related substances between~     groups, with and without significant AHI.~   "
126026|NCT01405963|"~     The purpose of this study is to assess the late asthmatic response, safety and tolerability~     of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild~     atopic asthma.~   "
126027|NCT01405950|"~     A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics,~     Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels~     in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral~     Palsy.~   "
126028|NCT01405937|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and~     ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed~     after previous therapy with interferon-based therapy. The primary efficacy hypothesis is~     that the percentage of participants achieving sustained virologic response 24 weeks after~     completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily~     treatment regimens is greater than 20% (historical data of standard of care treatment).~   "
126029|NCT01405924|"~     This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant~     (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3~     antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting~     (CIV) in participants who experienced CIV in the first cycle of moderately emetic~     chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching~     in at least 20% of participants during the second cycle of MEC in participants who~     previously experienced vomiting during the first cycle of MEC.~   "
126030|NCT01405911|"~     This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin~     (MK-0431/ONO-5435) used once daily (qd) for Japanese subjects with impaired glucose~     tolerance who have inadequate glycemic control using diet and exercise therapy.~   "
126031|NCT01405898|"~     We are interested in the effect of diet on blood pressure. Our previous research has shown~     that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot~     juice has this effect in people with high blood pressure. Beetroot juice is naturally rich~     in nitrate (also found in most other vegetables but particularly in green leafy vegetables).~     We think that it is the nitrate that lowers the blood pressure.~   "
126032|NCT01405885|"~     This is a Phase I, parallel design open label study to evaluate safety, tolerability and~     immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid~     administered intradermally followed by electroporation in healthy adults~   "
126033|NCT01405872|"~     The primary objective of the study is to determine physician reported persistence with the~     Avonex PEN at Month 12/End of Study as well as determining factors associated with~     persistence. The secondary objectives for this study are as follows: To evaluate the~     tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To~     evaluate patient quality of life (QoL) while using the Avonex PEN for treatment~     administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the~     Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection~     procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence~     at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate~     overall patient satisfaction with the use of the Avonex PEN for treatment administration at~     Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12;~     and To evaluate the percentage of patients switching from caregiver to self-injection at~     Months 3, 6, and 12.~   "
126034|NCT01405859|"~     Doctors provide a ray of hope to children and their parents with the knowledge that, for~     most patients, symptoms of Tourette syndrome improve by the time they are young adults. The~     investigators do not know why some improve and others do not. This study is designed to help~     answer that question. The investigators will use magnetic resonance imaging (MRI) techniques~     to test whether individuals who experience improvement of their Tourette's (tic remission)~     have more mature brain connections than those who do not.~   "
126035|NCT01405846|"~     We are going to use a special type of bronchoscopy test to examine patients who have had~     previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine~     a) whether we can identify precancerous changes in their airways b) whether this type of~     testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has~     any effect on precancerous areas in the airway.~   "
126036|NCT01405833|"~     The primary objective of the study is to evaluate the safety, tolerability, and~     pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed~     schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).~      Secondary objectives of this study in this study population are to explore the repeated-dose~     immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following~     multiple-dose administration.~   "
126292|NCT01402492|"~     The aim of this study is to investigate the safety and effectiveness of buprenorphine in the~     presence of naltrexone for the treatment of cocaine dependence.~   "
126042|NCT01405755|"~     Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight~     in young children. In Mexico, breastfeeding extends well into the second half of infancy,~     but animal-source foods, cereals, and legumes are not regularly provided to the child by 9~     mo. This study evaluates whether knowledge and practices about dietary diversity and food~     consistency can be improved using a two-component intervention strategy in semi-urban~     communities in Mexico. The two components will deliver appropriate complementary feeding~     messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio~     messages and interviews. The intervention is evaluated using a cluster randomized design in~     small semi-urban communities in two states in Mexico with pre- and post-test questionnaires~     designed to assess changes in feeding behaviors.~   "
126043|NCT01405742|"~     The purpose of this pilot R34 trial is to determine the feasibility of a large single dose~     Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly~     recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint~     range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by~     thrombin generation. Safety will be measured by inhibitor formation and bleeding events~     unresponsive to up to two rescue doses.~   "
126044|NCT01405729|"~     The purpose of this retrospective study was to determine the accuracy of femoral tunnel~     placement utilizing Redfern et al's radiographic method for anatomic femoral attachment~     during MPFL reconstruction in addition to the resultant outcome.~   "
126045|NCT01405716|"~     The primary objective of this study is to determine the effectiveness of a mind-body program~     in increasing function and reducing pain among older adults with chronic low back pain~   "
126046|NCT01405703|"~     This is a prospective, level II evidence comparison between two cohorts. This study is~     designed to compare the percutaneous versus open approach for plate fixation of diaphyseal~     clavicle fractures. This study includes questionnaires and measurements that will collect~     data on incision-related numbness, union rates, overall outcomes, complication rates of the~     two methods, infection rates, and overall satisfaction. The surgical procedure, all~     radiographs and follow-up visits to a minimum of one year are the principle investigators~     (PI's) standard of care for this injury. Measurements and questionnaires are related to the~     study.~   "
126047|NCT01405690|"~     Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to~     assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the~     detection of coronary artery disease is on the rise, the current technology of the 64-row~     multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can~     affect image quality.To eliminate these patient related artifacts a more advanced 320-row~     MDCT was recently developed. The investigators therefore propose that the newly developed~     320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery~     luminal stenosis as an alternative to an invasive coronary angiogram.~   "
126048|NCT01405677|"~     The primary purpose of the original study was to assess whether the protection afforded by~     the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection~     afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a~     computer based modelling analysis of the long term protection afforded by the paediatric~     dose, and to compare this with the standard dose and also with an alternative hepatitis A~     vaccine (Havrix Junior).~   "
126049|NCT01405664|"~     The rationale for this research study is to evaluate the effect on clinical outcomes of~     weight bearing as tolerated after forage surgery for the treatment of osteochondral defects~     of the ankle, thus potentially eliminating the need for a period of immobilisation or~     non-weight bearing after surgery.~      The investigators hypothesize that their will be no difference in functional outcomes~     between weight bearing as tolerated as compared to non-weight bearing for six weeks after~     forage surgery for OCD of the ankle.~   "
126050|NCT01405651|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950~     across ascending multiple doses in healthy adult male and female subjects. The secondary~     objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by~     measuring plasma concentrations of ONO-6950 and pulmonary function.~   "
126051|NCT01405638|"~     Primary Aim: To evaluate the effect of a lifestyle intervention delivered through~     telephone-based motivational interviewing (MINT) versus a patient navigation intervention on~     blood pressure reduction and CRC screening.~      Hypotheses: Among black men, aged > 50 years with uncontrolled HTN and in need of CRC~     screening:~        1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to~          those randomized to the patient navigation intervention at 6 months.~        2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC~          screening rates compared to those randomized to the lifestyle intervention at 6 months.~   "
126052|NCT01405625|"~     Asthma has an especially great impact on poor urban children and their families. In addition~     to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low~     health literacy. Low health literacy is associated with poorer asthma outcomes. The~     provision of a written asthma action plan has been shown to help with asthma management and~     to reduce hospitalizations and ER visits. Poor urban families who may have low literacy may~     need an alternative asthma action plan to convey the treatment plan.~      This pilot study proposes to investigate whether a plain language asthma action plan can~     improve parent understanding and adherence with medication instructions, compared to~     standard written materials, among parents of children with asthma. This is an RCT in which~     parents of children with asthma will be randomized to either receive a pictogram-based low~     literacy asthma action plan, or a standard action plan (AAAAI), to examine whether those who~     receive the low literacy plan have improved asthma action plan knowledge when presented with~     a hypothetical scenario.~      A second part of the study is to examine whether providers who are given the pictogram-based~     low literacy asthma action plan will be more likely to counsel about certain aspects of~     asthma management (eg. need for daily medications even when sick, spacer use, confusion~     between everyday and rescue inhaler)compared to providers who receive use a standard action~     plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a~     hypothetical patient using the pictogram-based action plan or the standard action plan~     (AAAAI).~   "
126053|NCT01405612|"~     An open-label, single centre, randomised, cross-over study to examine the effect of~     ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of~     ulimorelin in healthy volunteers.~   "
126057|NCT01405560|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b~     (peg-IFN) and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC)~     genotype (GT) 1 who have not responded to previous treatment. The primary efficacy objective~     is to estimate efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the~     percentage of participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV~     RNA) 24 weeks after completion of all study therapy (Sustained Viral Response 24 [SVR24]).~   "
126058|NCT01405547|"~     Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in~     life. Recent evidence indicates that abnormalities that increase risk for diabetes may be~     initiated early in infancy. Since the offspring of women with diabetes have an increased~     long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic~     abnormalities on early nutrition and infant metabolic trajectories is of considerable~     interest. The purpose of the study is to investigate the impact of maternal nutrition and~     metabolic abnormalities in pregnancy on human milk and subsequently on infant health over~     the first year of life.~   "
126059|NCT01405534|"~     It is an observational, prospective, monocentric study. The purpose of the study is to~     assess the acute complications rate caused by a central venous catheter placement.~      All the patients who require a central venous placement could be enrolled in the study.~      The study will not change the usual practice. The placement will be on day 1 and patients~     will be contacted by phone on day 7 to identify potential complications and to assess pain.~      Anaesthesia staff will keep patients under surveillance to control the absence of late~     complications.~   "
126060|NCT01405521|"~     Using an established model of human typhoid infection, whereby healthy adults are~     deliberately infected with typhoid-causing bacteria, the investigators will determine how~     effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously~     licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used~     works properly.~   "
126061|NCT01405508|"~     This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate~     safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for~     adults with epilepsy according to an initiation or a conversion scheme, during repeated~     dosing (100 mg/administration twice daily for 4.5 days).~   "
126062|NCT01405495|"~     The goal of this study is to identify the early modifications in fronto-temporal~     connectivity in female victims who developed PTSD, compared to female victims who did not~     develop the disorder, and to healthy control females. The investigators will compare between~     all these groups, structural and functional differences using different techniques (MRI,~     fMRI, DTI and ASL), and paradigms (cognitive tasks or at rest).~   "
126063|NCT01405482|"~     Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the~     irritation on the neurovascular structures at the interscalene triangle in subjects with~     TOS. This will lead to reductions in pain and paresthesias, and improvements in function~     when compared with injection of placebo.~   "
126064|NCT01405469|"~     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic~     myotomy for the treatment of achalasia in a single center setting in Europe.~   "
126065|NCT01405456|"~     The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle~     modification to affect sugar metabolism, body fat distribution, and cardiovascular health in~     HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that~     aldosterone, a hormone that regulates salt and water balance, is increased in association~     with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals,~     aldosterone appears to be higher in individuals with increased belly fat, and increased~     aldosterone appears to be strongly associated with impaired sugar metabolism. In this study,~     the investigators will test the effects of eplerenone, which is a medication that blocks the~     actions of aldosterone, along with lifestyle modification. The investigators hypothesize~     that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and~     reduce fat accumulation in liver and muscle.~   "
126066|NCT01405443|"~     This is a randomized controlled trial evaluating three training intervals using an endoscopy~     simulator for novices and comparing performance after training.~   "
126067|NCT01405430|"~     It is a prospective, non-randomized, monocentric study. The purpose of the study is to~     assess the predictive value of VE-cadherin on the objective tumor response.~      Biological factors will be correlated to clinical outcome measures.~      100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be~     enrolled.~      Patients will be followed every 10 weeks until progression in spite of bevacizumab or until~     they stop bevacizumab because of toxicity.~      Bevacizumab will be administered according to investigators appreciation.~      Blood samples will be collected at enrollment, at second bevacizumab's administration and~     every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or~     until one year at most in case that patients still receive bevacizumab.~   "
126068|NCT01405417|"~     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic~     myotomy for the treatment of achalasia in a multi center setting.~   "
126069|NCT01405404|"~     The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on~     increasing parent participation rates in a preventive parent training program called the~     Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of~     the Chicago Parent Program in childcare centers serving low-income families with young~     children.~   "
126070|NCT01405391|"~     Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose~     (RD) of PM01183.~   "
126083|NCT01405222|"~     Acute exacerbations of COPD remain a common cause of morbidity and are associated with a~     sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume~     and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7%~     of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine~     whether this can be a objective marker of exacerbation duration and severity.~   "
126293|NCT01402479|"~     Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated.~     Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators~     attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.~   "
126071|NCT01405378|"~     Every five minutes someone in the UK has a stroke. It is the main cause of long-term~     disability among adults in the UK despite a fall in age-specific stroke incidence, with a~     growing number of survivors remaining dependent for activities of daily living. While most~     people with stroke regain walking ability, upper limb problems with no voluntary arm and~     hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial~     direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions~     through the application of weak direct currents and has the potential to develop into a~     useful aid to treatment strategies in neurorehabilitation. Recent literature into the~     application of tDCS in people with arm and hand impairments after stroke has shown promising~     results on upper limb function measures like the Jebsen-Taylor hand function test.~     Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS~     with robot-assisted hand training and reported significant improvements in upper limb~     function. However, the robot in the latter study focused on single-plane distal movements~     only and long-term effects of the tDCS were not assessed. Recent robotic developments~     included robots with three rotational degrees-of-freedom for the upper limb, but the~     effectiveness of this type of robot combined with tDCS in early stroke settings is unknown.~     Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref:~     11/SC/0345) to conduct this study.~   "
126072|NCT01405365|"~     The purpose of this study is to investigate the effect that obesity may have on the~     nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive~     periodontal diseases (chronic periodontitis).~   "
126073|NCT01405352|"~     In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4~     month supplementation of vitamin A will be compared with placebo intaking group.~   "
126074|NCT01405339|"~     Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic~     rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's~     Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is~     believed that the MAD is a better device than the standard nasal lavage because its fine~     mist enhances absorption and improves bioavailability. No studies have been done to~     determine if enhanced absorption and improved bioavailability of budesonide via MAD could~     potentially affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the~     suppression of our own body's production of natural steroids.~   "
126075|NCT01405326|"~     The purpose of the study is to assess whether a 6-month treatment with adalimumab added on~     the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days~     on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of~     the intervention compared to the conventional treatment is evaluated, and the patients who~     benefit most are characterized.~   "
126076|NCT01405313|"~     This study will determine if modified adaptive servoventilation (ASV) is as effective as the~     conventional ASV in treating periodic breathing. The study will determine if the modified~     ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of~     positive airway pressure compared to conventional ASV.~   "
126077|NCT01405300|"~     Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and~     insulin response when incorporated into an acute high fat/high glucose meal. However, it is~     unclear whether acute consumption of peanuts can also influence vascular function. This~     study will therefore evaluate the effects of acute peanut consumption on vascular function,~     glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a~     high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve~     endothelial function as measured by flow-mediated dilation (FMD).~   "
126078|NCT01405287|"~     OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after~     deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered~     Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo~     native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in~     length.~      STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed~     to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent~     versus the commercially available everolimus eluting stent (Xience V or Promus). Patients~     will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA)~     follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180,~     360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all~     participants of the study.~   "
126079|NCT01405274|"~     This study will investigate whether adding a physiotherapy intervention to standard~     Emergency Department care will lead to improved recovery following an ankle sprain in the~     pediatric and adolescent population as well as to a decrease recurrence of injuries during~     the year following the initial ankle sprain. Children will be allocated to standard care or~     to the added intervention group. The study hypothesis is that recovery will be better while~     recurrence of injury will be less in those receiving the added physiotherapy intervention.~   "
126080|NCT01405261|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of NNC 0113-0987 in healthy male subjects.~   "
126081|NCT01405248|"~     The purpose of this study is to determine whether butylphthalide are effective for~     Preventing Restenosis after Intracranial and Extracranial Artery Stenting~   "
126082|NCT01405235|"~     Current planning for studies involving patients with recurrent, persistent, or metastasized~     cervical cancer must take into consideration that up to 75% of all patients are assumed to~     have already been treated with cisplatin in conjunction with radiation therapy. It seems~     questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it~     is important to seek alternative active combinations. The studies GOG 169 and 179~     demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin~     monotherapy with respect to therapeutic response and progression-free survival, as was a~     combination of topotecan and cisplatin with respect to therapeutic response,~     progression-free survival, and total survival. To achieve further improvement in total~     survival and to answer questions regarding the value of using a platinum-free combination,~     we propose that a study should be conducted to compare the efficacy of a platinum-free~     combination of paclitaxel and topotecan to a combination of cisplatin and topotecan.~   "
126084|NCT01405209|"~     Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of adults, with its~     prevalence increasing with age [1]. It is associated with increased morbidity and mortality.~      Most patients who develop AF have architectural and anisotropic micro changes in the atrial~     myocardium. These cause heterogeneous and discontinuous changes in the patterns of impulse~     propagation, heterogeneous atrial activation and shortening of atrial refractory period [2,~     3].~      Since 1911 the standard EKG [4] (approximately 15 seconds of recording and bandwidth 0.05 to~     150 Hz) is the most used tool for the evaluation of patients with arrhythmias, due to its~     low cost and high availability. Various electrocardiographic patterns are known predictors~     of AF as evidenced by direct visual inspection. For example, prolongation of P wave duration~     during sinus rhythm would correlate with structural changes such as increasing the size of~     the left atrium (the increase in left atrial pressure) or a decrease in driving time [5].~     These changes favor the development of reentry circuits responsible for the development and~     maintenance of AF.~      The registration of the electrocardiographic activity provides much more information than~     evidenced by direct visual inspection. Biosignal processing of these specific techniques to~     detect potential delays caused by abnormal conduction of the myocardium that favor re-entry~     mechanisms [6-10]. For this purpose prolonged ECG with 1000 Hz sampling frequency. Knowledge~     about the prediction of the development of AF with the standard ECG is not obvious on visual~     inspection is limited.~      Many of these structural changes and anisotropic, occur slowly over time and may be~     evidenced by direct variations between 2 ECG from the same individual [11]. Little is known~     about whether differences in morphology, axis, scope or duration of P wave related to these~     structural changes may predict the development of AF.~      Our main purpose is to evaluate the prognostic performance of a set of parameters as~     evidenced by direct inspection of the ECG, and ECG changes from 2 to predict the FA~     development. The design of this tool could allow future generation of software capable of~     identifying and reporting these variations, most useful prognostic risk in patients with AF.~   "
126085|NCT01405196|"~     The objective of this study is to evaluate and compare efficacy of 3 dose levels of~     PF-04236921 to placebo in subjects with generalized lupus using a measure called the~     Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and~     exploratory measures as well.~   "
126086|NCT01405183|"~     The purpose of this study is to determine if there is an association between hepatitis C~     infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will~     either have a biopsy or surgery will be offered to be tested for hepatitis C. The control~     group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).~   "
126087|NCT01405170|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets under fed conditions.~   "
126088|NCT01405157|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets under fasting conditions.~   "
126089|NCT01405144|"~     It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic~     keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging~     while treating Aks was reported.~      The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU~     use for forearms photoaging.~   "
126090|NCT01405131|"~     A study to determine whether a new formulation of methylprednisolone suspension is~     bioequivalent to methylprednisolone tablets.~   "
126091|NCT01405118|"~     This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of~     metformin, a probe drug for organic cationic transport.~   "
126092|NCT01405105|"~     Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative~     colitis.~   "
126093|NCT01405092|"~     Use of on-line blood volume monitoring during continuous renal replacement therapy can~     improve volume management in acute kidney injury patients requiring renal replacement~   "
126094|NCT01405079|"~     Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor~     receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR~     mutation rate was 30% in Chinese Non-small Cell Lung Cancer(NSCLC). Patients harboring these~     mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors~     (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works~     compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for~     stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.~   "
126095|NCT01405066|"~     The purpose of this study is to quantify variation in radiation dose levels across CT~     technologists, and determine the effectiveness of combining radiation dose audit reports and~     an educational seminar as a means to reduce the variation and level of patient exposure to~     radiation.~      The investigators expect the radiation dose audit reports and educational seminar will lead~     to reduced radiation exposure to patients by making technologists more aware of the risks of~     radiation exposure from CT exams and identifying technologists with higher radiation exams~     compared with their peers.~      The investigators expect the degree to which a technologist is concerned and aware about~     radiation exposure and cancer risk will be associated with adherence to radiation reduction~     protocols and the subsequent level of radiation their patients are exposed to when receiving~     a CT examination.~   "
126096|NCT01405053|"~     This study is designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK)~     of rufinamide on Lennox-Gastaut Syndrome inadequately controlled in pediatric subjects~     already taking other anti-epileptic drugs.~   "
126097|NCT01405040|"~     The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from~     existing indwelling femoral arterial Volume View™ catheter and central venous catheters.~   "
126098|NCT01405027|"~     The purpose of this study is to evaluate the impact of a physician directed education~     program on treatment compliance of hepatitis C patients administered triple drug therapy of~     pegylated interferon, ribavirin and boceprevir.~   "
126099|NCT01405014|"~     The objectives of this research pilot project are to assess the efficacy of the Hold Me~     Tight Relationship Enhancement Program with couples where at least one partner has an~     acquired brain injury.~   "
126100|NCT01405001|"~     This represents the first prospective examination of advanced airway management under combat~     conditions. The findings will have a tremendous impact on both modern prehospital medical~     practice and on the treatment of our wounded Soldiers during the Global War on Terrorism.~   "
126144|NCT01404429|"~     To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in~     patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2~     weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of~     efficacy) versus the adverse effects.~      Hypothesis: There will be no difference in the adverse effects, but better and faster~     control of disease when starting with a higher methotrexate dose~   "
126294|NCT01402466|"~     The study will test an intervention to help HIV-positive people achieve consistency of HIV~     care while transitioning in and out of jail.~   "
126101|NCT01404988|"~     In the VIP (Veterans Intensive Personalized) Treatment in Heart Failure Study we will assess~     2 novel interventions to enhance adherence and improve quality of life in veterans with~     heart failure. This 3-arm randomized controlled trial will base one active arm on how ready~     patients are for change in terms of diet and medication adherence and will tailor the~     intervention based on this. The other active arm will also assess how ready patients are for~     change, but will also include tailoring based on availability of environment resources, such~     as proximity to health food stores or social support, to further tailor the intervention.~     The last active arm is simply an attention group where patients will receive general health~     counseling in addition to background care that all patients receive. The overarching~     hypothesis is that the tailored interventions will lower heart failure (HF) recurrence and~     improve quality of life by better medication and diet adherence compared to attention~     placebo.~   "
126102|NCT01404975|"~     Trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. It is~     offered to elderly patients with medical problems that would markedly increase the risk of~     conventional cardiac surgery. The rate of delirium (acute confusional state) after surgery~     in these patients may exceed 50%. Estimated hospital costs associated with delirium at~     Toronto General Hospital last year exceeded $1-million CAD. Pain after surgery and the use~     of opioids (morphine type of pain-relief drugs) are known to increase the risk of delirium.~     The investigators plan to minimize the use of opioids and improve pain management by~     replacing the standard intravenous opioid-based pain management with the paravertebral nerve~     block using only the local anesthetic. These two management strategies will be compared with~     respect to the rate of delirium, duration of hospital stay, and the overall costs.~      Hypothesis: Paravertebral analgesia with LA decreases the incidence of delirium after~     trans-apical AVR when compared to standard systemic opioid-based analgesia.~   "
126103|NCT01404962|"~     This is a multicenter, post marketing surveillance study which aims to evaluate the safety~     profile of haemophilus influenza type b vaccine when administered to Korean children~     according to the product insert.~   "
126104|NCT01404949|"~     The purpose of this study is to find what effects, good and/or bad, treatment with two drugs~     has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA,~     or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It~     is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved~     medicine for APL that comes back after earlier treatment.~      APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy~     drugs can cause infection and bleeding. They can also damage the heart and normal bone~     marrow cells. This can lead to a second leukemia years later.~      In this study, the investigators are using tretinoin and arsenic trioxide together. Both~     drugs work to treat APL. They have been used together in only a limited number of people.~     The investigators want to use these drugs together to reduce the amount of standard~     chemotherapy and decrease side effects. The patient will receive standard chemotherapy with~     a drug called idarubicin only if they have a higher chance of the leukemia coming back or a~     higher risk of side effects.~   "
126105|NCT01404936|"~     This is a clinical research study of interferon (IFN) plus chemotherapy with the standard~     combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be~     given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD~     improves the immune response against Hodgkin's disease, and will determine whether the~     toxicity of ABVD is increased by adding IFN.~   "
126106|NCT01404923|"~     The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:~        -  Strategy A = MeteoSpasmyl®, on-demand therapy~        -  Strategy B = standard of care chosen by the physician~   "
126107|NCT01404910|"~     Preeclampsia is a syndrome that occurs in approximately 3% to 8% of pregnancies and is~     associated with considerable maternal and neonatal morbidity and mortality. Except for~     termination of the pregnancy, effective treatments/preventative measures for preeclampsia~     are lacking. Although prolongation of pregnancy benefits the fetus, it is detrimental to the~     mother, and is associated with hypertension, proteinuria, and symptoms that suggest kidney,~     brain, liver and cardiovascular system involvement.~      Placental soluble fms-like tyrosine kinase 1 (sFlt-1) is elevated in women with~     preeclampsia, with levels that fall after delivery. sFlt-1 is a variant of the vascular~     endothelial growth factor (VEGF) receptor Flt-1, and in the circulation, acts as a potent~     VEGF and placental growth factor (PlGF) antagonist. Given that sFlt-1 levels are elevated in~     preeclampsia, we are investigating if removal of sFlt-1 from the plasma of women with~     preeclampsia can improve maternal and fetal outcomes.~      Short-term extracorporeal apheresis with the LIPOSORBER LA-15 System will be the primary~     intervention using methods that have been previously applied in pregnant women with familial~     hypercholesterolemia.~   "
126108|NCT01404897|"~     The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood~     pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no~     benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk,~     namely HDL-cholesterol and triglycerides. The overall objective of this study is to~     determine whether modification of the DASH diet by substituting carbohydrate with fat will~     result in improvements in multiple biomarkers of CVD risk. Specifically, the investigators~     will test the hypotheses that modification of the DASH diet by reducing carbohydrate,~     primarily in the form of simple sugars and glycemic starches, and allowing for a more~     liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve~     lipoprotein markers of CVD risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL~     particles, and increased HDL-C, apoAI, and large HDL particles); and (2) result in~     comparable reductions of systolic and diastolic blood pressure to those achieved with the~     standard DASH diet. The investigators will also assess the effects of the modified DASH diet~     on markers of insulin resistance and inflammation. Our main hypotheses will be tested by a~     controlled dietary intervention conducted in 40 healthy men and women who will be randomly~     allocated to consume, for 3 weeks each, a control Western diet, a standard DASH diet, and a~     modified low-carbohydrate DASH diet, separated by 2-week washout periods.~   "
126307|NCT01402297|"~     The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive~     oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects~     of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC)~     after 30, 60 and 120 minutes.~   "
126109|NCT01404884|"~     This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACR~     presbyopic excimer laser treatment algorithm for myopic eyes developed for applying to the~     cornea of the human eye in a single center.~      The developed software algorithm uses the subjective refraction of the eye to create a~     treatment for the distance vision correction. This part of the treatment does not show any~     difference to a regular aspheric LASIK treatment for myopic cases.~      In addition to the treatment for the distance vision an additional central ablation~     component will be added to address the near vision.~      The study design is applied as a single center unilateral eye safety and effectiveness study~     of the SUPRACOR presbyopic algorithm for myopia with a 3 months postoperative follow up.~   "
126110|NCT01404871|"~     In this study, the investigators hope to study a number of variables the investigators~     believe may help us predict why some people respond better to some medications than others.~     Participants will be randomly assigned to receive one of two typical medications for OCD,~     clomipramine or escitalopram. Individuals who would like to participate but who have~     previously tried one or both of these medications may instead take a newer drug, duloxetine,~     and undergo the identical procedures. The factors the investigators will be studying include~     demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in~     genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes~     involved in several brain chemical systems, such as serotonin), the dimensions of OCD~     symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition~     will be measured transcranial magnetic stimulation and is being studied because deficits in~     this process may be important in the development of OCD. The investigators hypothesize that~     certain pretreatment clinical characteristics will correlate with poor treatment response~     including earlier age of onset, longer duration of illness, increased YBOCS severity and~     presence of significant hoarding symptoms. The investigators expect that increasing degree~     of deficit in CI pre-treatment will predict poor treatment response, but that increase in CI~     from pre- to post-treatment will correlate with a positive treatment response. Differences~     in genetic marker status for cytochrome P450 genes will correlate with tolerability and/or~     response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A~     will correlate with response.~   "
126111|NCT01404858|"~     The purpose of this study is to prospectively examine the impact of various lifestyle habits~     in both men and women on the outcome of in vitro fertilization. There are 25 infertility~     centers in the United States which use the electronic medical record collection entity eIVF,~     made by Practice Highway, to collect medical and demographic information on the patients who~     are undergoing treatment at these centers. Information on every aspect of each cycle is also~     electronically collected daily during each cycle. Demographic and lifestyle information will~     be collected on all patients prior to cycle start and lifestyle habit information will be~     collected each time a patient logs onto the patient portal, which averages every few days.~   "
126112|NCT01404845|"~     •Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and~     visual impairment in industrialized countries. The macular pigment, composed of carotenoid~     derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An~     increase in macular pigment following dietary supplementation with lutein and zeaxanthin~     could allow early treatment with such supplements in subjects with a high risk of AMD, and~     encourage them to change their eating habits.~      •Primary outcome:~      Comparative analysis of the density and evolution of the density of macular pigment:~        -  In patients without any retinal pathology who underwent cataract surgery 1 month~          previously~        -  In the non-exudative eye of patients with exudative AMD in one eye by analyzing the~          density and evolution of the density of macular pigment in the non-exudative eye~             -  Secondary outcomes:~      Analysis of changes in macular pigment density after taking food supplements (Nutrof Total~     versus comparator):~        -  Time taken to reach the maximum plateau of macular pigment density (no increase in~          density between 2 measurements)~        -  Time taken to return to the baseline macular pigment density after cessation of~          supplementation~             -  Study design :~      Pilot study -Prospective, randomised, double-masked, comparative, multicenter.~   "
126113|NCT01404832|"~     Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to~     be due to GERD experience only incomplete relief of their symptoms. Those patients are~     deemed PPI failures. Esophageal pH monitoring studies have shown that PPI failure rarely~     is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with~     PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown~     etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where~     they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic~     esophagitis underlies PPI failure for patients with GERD symptoms.~      Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of PPI~     failure in patients thought to have heartburn due to GERD.~      Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical~     Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to~     participate in the study. Patients who provide informed consent will have a medical history~     taken. Women of child bearing potential will have a pregnancy test. The patients' current~     PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID~     for one week. The patient will return to the clinic one week later. Patients who feel that~     their heartburn has not improved by more than 50% from baseline will have an endoscopic~     evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A.~     Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens~     from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal~     esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal~     esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion~     of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more~     extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be~     made if there is at least one high-power field with >25 eosinophils, or two or more~     high-power fields with >15 eosinophils.~      Potential Benefits: This study will provide an estimate on the frequency with which~     eosinophilic esophagitis is the cause of PPI failure in patients thought to have heartburn~     due to GERD. This has substantial potential importance for patient management.~   "
126114|NCT01404819|"~     The objective of this study is to show that, in patients undergoing carotid endarterectomy,~     brain damage, assessed by the determination of S100B before removing the clamp, is less~     severe with a balanced anesthesia consisting of remifentanil combined with Xenon~     (experimental arm) compared with remifentanil anesthesia associated with propofol (reference~     arm).~   "
126115|NCT01404806|"~     The purpose of this study is to describe drug concentrations of an investigational HIV~     medication, GSK1349572, in blood plasma, cervicovaginal fluid, vaginal and cervical tissue~     in HIV negative women.~   "
126166|NCT01404143|"~     What is the difference in subscapularis strength between two different methods of~     subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a~     hand-held dynamometer in the belly-press position at one year post operative? It is the~     investigators' hypothesis that a peel of the subscapularis will result in greater strength,~     a higher healing rate, and a greater improvement in shoulder function and quality of life~     following shoulder replacement.~   "
126116|NCT01404793|"~     Standard anesthetic management of liver transplantation patients includes a general~     anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium.~     Pharmacokinetic modelling of this agent has been poorly described during liver~     transplantation, which impacts on appropriate dosing of this agent within this population~     where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during~     the various phases of liver transplantation. Plasma drug and drug metabolite concentrations~     will be measured using the technique of solid phase micro-extraction (SPME). Measuring and~     correlating the levels of rocuronium and other liver metabolites with the degree of post~     transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid~     diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity~   "
126117|NCT01404780|"~     Patients undergoing chest surgery often require insertion of a breathing tube (double lumen~     tube) after they are unconscious. The double lumen tube enables the anaesthetist to~     ventilate (assist breathing) one lung at a time. The other lung is partially deflated to~     enable enough space for the surgeon to perform the procedure. The breathing tube is inserted~     with a laryngoscope (blade with a light at the end) so the vocal cords can be seen. This is~     standard medical practise. Two laryngoscopes are commonly used at Toronto General Hospital~     to insert the tube. The Macintosh laryngoscope has been is use for over 50 years and the~     Glidescope for over 10 years. Both devices have been extensively researched for single lumen~     tubes insertion and found to be very safe and effective. Research is limited to say which of~     the two laryngoscope is the most effective for double lumen tubes.~   "
126118|NCT01404767|"~     This study proposes to assess the effect of the standard of care, which is continuation of~     the pre op beta blocker dose into the post operative period compared to the administration~     of esmolol titrated to a pre determined target HR. The primary outcome will compare~     postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on~     metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been~     withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes~     will compare a) the hemodynamic responses, documenting the incidence of unplanned~     hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of~     myocardial ischemia, arrhythmias, delirium and infarction.~   "
126119|NCT01404754|"~     This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on~     mood and psychological experience in people trained to practice MDMA-assistant psychotherapy~     in a therapy-like setting. Study participants will prepare for the experience with the~     investigators. After preparation, they will have two day-long sessions, one with placebo and~     one with MDMA, with the second session happening two days after the first. Order of session~     will be assigned randomly and the study will be double-blind. Subjects will complete~     measures and talk about the experience on the day after each session. Mood, psychological~     symptoms, and interpersonal closeness will be measured before and after each session. The~     investigators will speak with subjects again one and two months after the second~     experimental session, and subjects will complete a personality questionnaire two months~     after the second experimental session.~   "
126120|NCT01404741|"~     5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS),~     but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment~     option but is associated with a high risk treatment-related morbidity and mortality. In the~     current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only~     treatment according to donor availability in elderly patients with MDS (55-70 years).~   "
126121|NCT01404728|"~     This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal~     stenosis in women receiving pelvic radiation therapy for pelvic malignancies.~   "
126122|NCT01404715|"~     This study will address the following question: Does imatinib influence the pharmacokinetics~     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have~     indicated that imatinib may block metformin elimination from the kidney by inhibiting~     organic cation transporter efflux of metformin. 1. The investigators hypothesize that the~     addition of imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin~     leading to increased plasma concentrations and risk for toxicities 2. Knowledge of the~     pharmacokinetic interaction profile of metformin with organic cation transporter inhibitors,~     such as imatinib, is important to help develop safer more effective drug therapy with~     reduced side effects.~   "
126123|NCT01404702|"~     Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual~     incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of~     childhood cancer deaths. High risk (HR) patients carry a poor prognosis despite treatment~     with intensive chemotherapy, surgery and/or radiation, autologous bone marrow transplant,~     and treatment with cis-retinoic acid. New therapies are desperately needed for such~     patients. Recently, it has been demonstrated that HR NB patients benefit from anti-GD2~     antibody therapy which directs the immune system against NB cells. To further explore means~     of harnessing the immune system to attack NB, the investigators are studying the combination~     of zoledronic acid (ZOL) and interleukin-2 (IL-2). ZOL has been demonstrated to have direct~     anti-neuroblastoma effects in laboratory studies. ZOL also augments the production of tumor~     killing white blood cells called gamma-delta T cells. When used in combination with IL-2,~     ZOL is capable of eliciting potent anti-cancer effects in patients, in part, via the~     expansion of gamma-delta T cells. In this present trial the investigators aim to study the~     tolerability of the combination of ZOL and IL-2 in pediatric NB patients. Patients will also~     be monitored radiologically for tumor response to therapy. Correlative biological studies~     will study the ability of this drug combination to elicit the production of NB killing~     gamma-delta T cells in children.~   "
126179|NCT01403974|"~     This study is a phase I, open-label, dose escalation trial to determine the maximum~     tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new~     drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be~     involved in cancer growth. BI 836845 will be administered for the very first time into~     cancer patients.~      The study will also look at the overall safety of the drug, and examine the drug levels in~     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the~     drug may have on tumours will also be examined (pharmacodynamics).~   "
126180|NCT01403961|"~     The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in~     patients with diabetes type II and the complication incidence in immediate post surgery.~   "
126124|NCT01404689|"~     Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more~     complex to perform than the other parallel procedures, causing discomfort to patients. It is~     commonly performed under sedation endoscopy. Until recently, the combination administration~     of midazolam and opioid has been widely used as standard therapy due to its superior~     sedation effect compared to the other sedation agents. Midazolam, however, has problems,~     such as an insufficient sedation effect and an intermittent paradoxical response.~      Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory~     depression, and has a narrow therapeutic range for the sedation effect, consequently~     requiring supervision by experienced experts, although it has a better sedation effect than~     midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.~      Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the~     proper level of sedation and has a weak influence on respiratory depression. Recent studies~     have shown positive results with dexmedetomidine in relation with the sedation effect for~     surgery patients under local anesthesia or in intensive care units.~      As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic~     procedures due to the increased attention to dexmedetomidine. This notwithstanding, the~     clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use~     of dexmedetomidine for ERCP are very rare.~      Given the recent idea that dexmedetomidine may exert a synergistic effect in combination~     with midazolam, these authors endeavored to prospectively compare and analyze the sedation~     effect and adverse events, including respiratory depression, of the combination therapy of~     midazolam and meperidine, both of which have been widely used in patients undergoing ERCP,~     and of the combination therapy of midazolam, meperidine, and dexmedetomidine.~      The small-scale comparative study on the combination administration of propofol and~     fentanyl, which has a high risk of causing complications, and on the single administration~     of dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP~     procedure that has yet been conducted; there has been no study that investigated the effect~     of the combination administration of dexmedetomidine and other drugs in the ERCP procedure.~     This study is thus expected to contribute to the development of guidelines on sedation in~     the ERCP procedure.~   "
126125|NCT01404676|"~     The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic~     variability, oxidative stress, and endothelial function in patients with type 2 diabetes.~   "
126126|NCT01404663|"~     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can~     involve brain and nervous system functions such as movement, learning, hearing, seeing, and~     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these~     problems occur as the baby grows in the womb, but they can happen at any time during the~     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem~     cells are known as a effective therapy.~      In this study the investigators evaluate the side effect of bone marrow stem cell~     transplantation in patients with cerebral palsy.~   "
126127|NCT01404650|"~     This is a multicenter, non-randomized, single agent, Phase II study of AUY922 in patients~     with refractory Gastrointestinal Stromal Tumor (GIST). The primary endpoint of this study is~     to determine progression-free survival (PFS) for patients with GIST receiving AUY922~     intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle with restaging at 6 and~     12 weeks and then every 9 weeks thereafter. Patients may continue treatment until evidence~     of disease progression.~   "
126128|NCT01404637|"~     The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal®~     D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe~     symptomatic benign prostatic hyperplasia as a first line therapy.~   "
126129|NCT01404624|"~     The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense~     and the plasma ghrelin level which increases unusual from the recently PWS patients was~     discovered. The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with~     peptide hormone and the location is 3p26-p25. Becomes the secretion even from nervous system~     but from dignity X/A cell it is secreted mainly and growth is important even in the vagal~     control against food and intake and a dignity function even on the action outside which~     promotes the secretion which drives it operates. It increases food intake specially and in~     order to accomplish the action which diminishes fat utilization the obesity with the week~     cause which it does the mortar it is thought. Active the ghrelin of the form is essential in~     hormonal activity of the ghrelin and appetite and growth hormone it participates to the~     secretion promotion which drives. Action of the Ghrelin measuring the quantitative change in~     middle acylated of the PWS patient ghrelin in order to happen after the acylation initially~     by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled~     the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it~     will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS~     patient and the blood of the normal army and active ghrelin it measured a change.~   "
126130|NCT01404611|"~     The purpose of this study is to determine if a combination of an antibiotic plus a~     corticosteroid is safe and effective in treating middle ear infections in children with ear~     tubes.~   "
126131|NCT01404598|"~     This study will be performed in 2 parts conducted in parallel:~      Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen~     500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the~     pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the~     elimination of the drug after its administration) of nitrates (metabolite of naproxcinod)~     present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for~     7 days or naproxen 500 mg bid for 7 days as a reference.~      Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod~     3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e.~     the absorption, the distribution, the metabolism and the elimination of the drug after its~     administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the~     transformation of the naproxcinod, after oral administration of a single supratherapeutic~     dose of 3000 mg.~   "
126132|NCT01404585|"~     The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate~     is effective in treating moderate to severe rheumatoid arthritis.~   "
126133|NCT01404572|"~     The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral~     use (POU) formulations to the current atazanavir POU in healthy participants and to select 1~     atazanavir POU that has the sweetness most similar to the current atazanavir POU.~   "
126134|NCT01404559|"~     Many service members suffering major limb amputation(s) during active duty seek to return to~     active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic~     differences exist between popular multi-function prosthetic feet that would facilitate~     return to duty for soldiers with amputations.~   "
126135|NCT01404546|"~     This pilot study examined the effect of providing a 4 weeks of cost free quit smoking~     medications to smokers identified in a stroke prevention clinic who were interested in~     quitting smoking compared to providing a prescription for the medication only.~   "
126181|NCT01403948|"~     The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability,~     pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or~     refractory non-Hodgkin lymphoma with at least prior treatments.~   "
126136|NCT01404533|"~     The overall goal of this research is to develop safe and effective iron interventions that~     can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in~     the systemic circulation not bound to the iron-transport protein transferrin). The~     appearance of plasma non-transferrin-bound iron has been reported in uninfected adult~     volunteers after oral administration of iron supplements in doses similar to those used in~     the Pemba trial. This research project will (i) confirm the appearance of plasma~     non-transferrin-bound iron after administration of an iron supplement like that in the Pemba~     trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production~     of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes~     (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of~     giving a lower dose of iron (~0.1 mg Fe/kg) — like that used in home fortification — with~     the standard rice meal.~   "
126137|NCT01404520|"~     The purpose of this study is to test a new preventive and restorative intervention for~     patients with acute leukaemia undergoing consolidation chemotherapy, to measure and~     delineate the patients' treatment related symptom burden and to explore the effect of the~     intervention on length of hospital stay, duration of sick leave and return to work status.~     Further, to examine the relationship of the symptom profile with clinical indicators,~     physiological response, physical performance and survival.~   "
126138|NCT01404507|"~     The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended~     by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to~     potential increase of bleeding. Compared bolus injection followed by continuous infusion of~     Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding~     complication while maintaining decrease ischemic events. It was also reported that direct~     intracoronary injection of abciximab might be superior to intravenous injection regarding~     myocardial perfusion.~      Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of~     acute ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that~     combination of intracoronary abciximab bolus injection and aspiration thrombectomy might~     enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial~     infarction. We will determine whether combination of intracoronary abciximab injection and~     aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion~     through index of microcirculatory resistance and cardiac magnetic resonance imaging.~   "
126139|NCT01404494|"~     Background:~      - Previous studies have shown that computer-based devices that simulate everyday tasks can~     be helpful for evaluation and rehabilitation in people who have had strokes. Researchers are~     interested in studying whether similar devices can be used to evaluate and treat individuals~     who have had a traumatic brain injury, to determine if the device should be developed to~     help with rehabilitation in the future.~      Objectives:~      - To evaluate the effectiveness of a computer-based simulation compared with actual~     performance of actions in individuals who have had a traumatic brain injury.~      Eligibility:~      - Individuals at least 18 years of age who have had a non-penetrating mild or moderate~     traumatic head injury within the past year and have experience playing computer games.~      Design:~        -  Participants will be screened with a physical and neurological examination and medical~          history.~        -  Participants will complete questionnaires and an interview about mood and feelings,~          stress levels, quality of life, and how well they function at work or at home.~          Participants will also have tests of memory, attention, thinking, and reasoning. Some~          of the questionnaires and tests will be completed in writing, some orally, and some on~          a computer.~        -  Participants will have movement and coordination tests that involve simple tasks such~          as putting pegs in a pegboard, using a key, lifting different objects, and folding~          things.~        -  Participants will duplicate the movement and coordination tests by using a computer~          program that simulates the tasks with a cursor on a computer screen. Participants will~          do four separate simulated tasks (such as arranging letters or hitting a nail with a~          hammer) three times.~        -  The full visit will take about 4 hours, and no followup visits are required.~   "
126140|NCT01404481|"~     The purpose of the study is to compare single use of catheters with reuse of catheters for~     intermittant self catheterisation.~   "
126141|NCT01404468|"~     The optimisation of drug absorption through skin is of great value in modern~     therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug~     absorption. However,few studies have compared pulsed and continuous modes of therapeutic~     ultrasound.This study compared these two modes by investigating the effect of lidocaine~     phonophoresis on sensory blockade.~      Ninety-three healthy volunteers, assigned at random to one of three ultrasound~     groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham~     ultrasound+lidocaine).~      Lidocaine was administered transdermally using a transducer.Two point discrimination, touch~     and maximum pain thresholds were assessed before and after the intervention in each group.~      Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared~     with continuous ultrasound with topical lidocaine gel and lidocaine application alone. The~     mechanical properties of pulsed ultrasound appear to be responsible for greater drug~     penetration.~   "
126142|NCT01404455|"~     The investigators examined the predictability of stroke volume variation for fluid~     responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery~     bypass graft~   "
126143|NCT01404442|"~     Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an~     additive to bupivacaine in patients undergoing cesarean section .~      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients~     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal~     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were~     randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received~     bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group~     (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group~     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time~     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory~     level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of~     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen~     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,~     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were~     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no~     pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the~     patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for~     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of~     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.~   "
126182|NCT01403935|"~     The purpose of this study is to create an institutional registry of sepsis through a~     prospective survey based on epidemiological data, risk factors, diagnosis, prognosis,~     treatment, monitoring and survival.~   "
126145|NCT01404416|"~     The follow-up study was based on our previous nutritional intervention trial entitled~     Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744). We~     followed up all livebirths born to women of the trial to measure their height, weight, and~     hemoglobin and to implement a questionaire survey (including developmental milestones,~     disease history, breast feeding, passive smoking, et al). We selected a sub-sample of~     infants to assess their IQ, emotional and behavioral problem, and language development~     status. The outcomes of interest include death, body mass index, overweight/ obesity,~     stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral~     disorder, language developmental status, and disease history. Other interesting exposure~     includes breast feeding, passive smoking, et al. We hypothesize that intrauterine~     nutritional exposure has an impact on offspring's physical, mental, and language~     development. We also hypothesize that cesarean delivery including CDMR has an impact on~     offspring's these outcomes.~   "
126146|NCT01404403|"~     This is a safety study of the Rapid System for acute ischemic stroke.~   "
126147|NCT01404390|"~     This study will be conducted as an open label, single centre, Phase I study of PI3K~     (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or~     refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8~     and Day 15 with three weeks on and one week off in each treatment cycle.~   "
126148|NCT01404377|"~     Prospective double blind randomized evaluation of the effect of surgical wound infiltration~     with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph~     node dissection~   "
126149|NCT01404364|"~     The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and~     retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.~   "
126150|NCT01404351|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative~     pain, adverse events and skin scarring following surgery; and to compare these outcomes to~     the HARMONIC SYNERGY® BLADE.~   "
126151|NCT01404338|"~     Tachyphylaxis occurs when a medication is applied multiple times and a decreased response~     takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly~     occur. Other believe that tachyphylaxis can be explain by patient non-compliance with~     topical medications. This study is looking to prove or disprove the phenomenon of~     tachyphylaxis by using topical steroids in the psoriasis patient population. The~     investigators are looking to enroll 10 patients with symmetric, bilateral, and small~     psoriasis plaques. The investigators will either apply a strong topical steroid or a vehicle~     ointment to the plaques, which is be occluded with a band aid for a one week period. Weekly,~     the investigators will inspect the plaques for tachyphylaxis. This regimen will be repeated~     during phase 2, to see if there is change in the time to tachyphylaxis. This regimen will be~     repeated during phase 3, however, both plaques will be treated with steroid in this phase,~     and time to tachyphylaxis will be measured.~   "
126152|NCT01404325|"~     This trial will evaluate the efficacy of Everolimus in combination with a centre specific~     standard immunosuppressive regimen versus a standard immunosuppressive regimen concerning~     kidney function in lung transplant recipients.~   "
126153|NCT01404312|"~     HIV-infected people have an increased risk of developing active tuberculosis (TB). The~     standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of~     treatment may be as effective and potentially increase treatment adherence. This study will~     compare the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH~     versus a standard 9-month regimen of INH in HIV-infected people who are at risk of~     developing active TB.~   "
126154|NCT01404299|"~     The purpose of this study is to determine whether protein-energy nutritional supplementation~     improves geriatric function in community-dwelling frail older adults of low socioeconomic~     status.~   "
126155|NCT01404286|"~     Purpose: The objective of this study was to evaluate the influence of a session of~     resistance training on the sleep patterns of elderly people.~      Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into~     two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent~     two polysomnography tests, one at baseline and another after either a resistance training~     session (One Repetition Maximum - Strength Test, resistance group) or without physical~     exercise (control group).~   "
126156|NCT01404273|"~     This research study is being done to examine how meditation and the relaxation response (RR)~     may change brain activity in attention-deficit/hyperactivity disorder (ADHD).~   "
126157|NCT01404260|"~     Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the~     standard first-line therapy for advanced non-small cell lung cancer (NSCLC).~      Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical~     efficacy, as compared with the best supportive care or standard chemotherapy, when given as~     second-line or third-line therapy for advanced NSCLC.~      Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with~     adenocarcinoma, and patients of Asian origin. In these populations, such treatment is~     associated with favorable objective response rates, progression-free survival, and overall~     survival. These populations also have a relatively high incidence of somatic mutations in~     the region of the EGFR gene that encodes the tyrosine kinase domain.~      The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to~     carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers~     or former light smokers in East Asia . In the subgroup of 261 patients who were positive for~     the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than~     among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup~     of 176 patients who were negative for the mutation, PFS was significantly longer among those~     who received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well~     tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung~     disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor~     could get benefit from gefitinib as first line treatment.~      Tony S. Mok and his colleague also found that intercalating and maintenance administration~     of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line~     therapy led to a significant improvement in PFS .~   "
126183|NCT01403922|"~     This is a two part study. Part 1 will determine determine if administration of TC-5214 has~     an effect on sitting blood pressure in patients with chronic hypertension.~      Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive~     Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).~   "
126184|NCT01403909|"~     The main objective of this study was to evaluate the effect of intermittent pneumatic venous~     compression on intra-operative fluid intake by comparing two groups of patients with or~     without intermittent pneumatic compression of the lower limbs.~   "
126325|NCT01402063|"~     To obtain preliminary data in a randomized phase II study whether PPX/RT improves~     progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT~     methylation.~   "
126158|NCT01404247|"~     Brief Summary~      The purpose of this study is to better characterize the retina and optic nerve in newborns~     using spectral domain optical coherence tomography (s-oct). This new technology provides a~     very detailed cross-section picture of the cellular layers in the retina and a 3-dimensional~     picture of the optic nerve head and the fovea (the center of the retina that provides the~     most accurate vision). These images have been used by doctors for more than 5 years to help~     diagnose and treat adults with eye diseases, such as macular degeneration, diabetic~     retinopathy, retinal detachments, and melanoma. But, it has never been studied in newborns.~     In newborns, it would potentially help in the diagnoses of glaucoma, optic nerve hypoplasia,~     foveal hypoplasia, and colobomata among many other disorders. Prior to diagnosing disorders,~     it is necessary to establish normal values. It is the purpose of this investigation to study~     the retina and optic nerves in neonates to establish normal values.~      After a parent of a normal newborn provides a written consent, the baby will be taken to the~     Eye Clinic where the instrument is located. The baby will be swaddled in one or more~     blankets as needed. The infants will be held in front of the instrument by a nurse. The~     technician will move the lens of the instrument to about 2 to 4 inches from the baby's eye.~     The mild light from the instrument will then enter the eye for a few seconds to obtain the~     desired image. The image can be captured through an immobile eye within 5 seconds. If the~     baby is fussy, he or she may be given a few drops of a sugar (sucrose) solution on a~     pacifier for calming. Although the images can usually be secured through a normal pupil, if~     the pupil is found to be too small, two drops of Cyclomydril will be placed on the eye for~     dilation. This is the eye drop used everyday in the Eye Clinic and nursery to dilate the~     pupils of babies. The dilation will last for about 6 to 10 hours. After the test, the baby~     will return to the nursery or be discharged home as intended by the Neonatology Division.~      There is minimal risk associated with this investigation. The instrument is non-invasive and~     does not touch the eye. The babies will be swaddled and held by a nurse to prevent any~     contact with the machine. The eye drop to be used if needed for dilation has been used on~     babies at Harbor for about 30 years. It has been found to very safe. The fact that we will~     study only term (not premature babies) and will apply only two drops if needed should~     minimize any risk from the eye drop.~      An ethical issue to consider is that while the study will provide important information that~     will undoubtedly help babies in the future, it will probably not benefit the baby being~     studied. However, if the baby has an undetected retinal or optic nerve problem, the study~     may reveal it.~   "
126159|NCT01404234|"~     This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis~     (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three~     28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each~     followed by 28 days off AZLI. The total treatment duration was to be 6 months.~   "
126160|NCT01404221|"~     Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound~     of the fetal face at approximately 20 weeks gestation identify fetuses with congenital~     anomalies and predict maternal and fetal complications?~   "
126161|NCT01404208|"~     The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a~     child gets cognitive behavioral therapy (CBT) can help children with pediatric~     obsessive-compulsive disorder.~      Cognitive Behavior Therapy is a talking therapy that will teach children new skills to~     better cope with his/her OCD. CBT usually uses exposure-based therapy. This means that the~     person with OCD slowly learns to deal with things they usually avoid. This is done by moving~     from less stressful situations to more challenging ones.~      The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this~     study at Massachusetts General Hospital (MGH). The National Institute of Mental Health~     (NIMH) is paying for this study to be done.~      If your child qualifies for the study, the investigators will assign him or her by chance~     (like a coin toss) to either the DCS group or the placebo group. You and the study doctor~     cannot choose your child's study group. Your child will have an equal chance (1 in 2) of~     being assigned to the DCS group.~      Your child will be asked to take one or two capsules of the study drug (either DCS or~     placebo, depending which study group they were assigned to) one hour before CBT visits 4-10.~     The study coordinator will give your child the study drug at the location of the CBT~     sessions. This is to make sure that your child takes the study drug one hour before his/her~     scheduled therapy session. We will ask you to record any bad side effect from the study drug~     that your child may have before each CBT session.~      It will take your child about 34 weeks to complete the study. During this time, the~     investigators will ask you and your child to make a minimum of 17 trips to the study center.~     There may be up to 23 trips when including CBT Booster sessions.~      This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS.~     The investigators use placebos in research studies to learn if the the results are caused by~     the study drug or are due to other reasons. This is a double-blind study. A double-blind~     study is a study where both the doctor and the study participant do not know whether the~     study participant is being given DCS or placebo.~   "
126162|NCT01404195|"~     1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the~          functional impairment experienced by sarcopenic patients with hip fracture using~          nutritional intervention. What makes this study different from prior studies is that it~          will be conducted in a hospital setting, unlike most prior studies, which were~          conducted in a community setting. The association between muscle mass and strength,~          inflammatory indices, and functional impairment versus dependence and fragility will~          also be measured.~        2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in~          metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective~          for treating sarcopenia in elderly patients with hip fracture and improves functional~          level.~        3. OBJECTIVES Primary objective is to assess functional improvement after nutritional~          intervention in sarcopenic patients with hip fracture, as measured using Barthel index.~           Secondary objectives will include: 1) to show the relationship between metabolic and~          inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment~          influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased~          strength; 5) to assess mortality and morbidity.~        4. EXPECTED RESULTS The investigators expect to find that the supplemented group~          experiences throughout the study period a significant improvement in functional status~          (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased~          strength and a reduction in associated complications (falls) are also expected. The~          investigators hope to be able to show reductions in inflammatory indices and insulin~          resistance.~      To conclude, by improving muscle strength and mass the investigators expect to find a~     reduction in the disability and dependence of this population group.~   "
126163|NCT01404182|"~     The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB~     trivalent influenza vaccine in adults and elderly people.~   "
126164|NCT01404169|"~     The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy~     compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's~     Disease.~   "
126165|NCT01404156|"~     The best treatment for resectable esophageal cancer or cancer between esophagus and stomach~     (GE junction) is unknown. Although an operation to remove the esophagus is the most common~     treatment, previous studies have shown that patients live longer when either chemotherapy or~     chemotherapy plus radiation (chemoradiation) is given before surgery (preoperative),~     compared to surgery alone. However it is unknown which of these treatments (preoperative~     chemotherapy or preoperative chemoradiation) is more effective in improving survival. A~     study where patients with resectable esophageal / GE junction cancer are chosen at random to~     receive one of the two preoperative treatments would help determine if one form of treatment~     improves survival compared to the other.~      Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized~     to receive either preoperative chemotherapy or preoperative chemoradiation followed by~     surgery.~      The main objective of this pilot trial is to determine the possibility of conducting a~     larger study with many centers participating. If this study proves to be feasible with~     enough patients enrolled and able to tolerate treatments without major side effects then we~     can hopefully proceed to perform a larger multi-center trial to look for survival outcome~     differences between patients who receive preoperative chemotherapy and those who receive~     preoperative chemoradiation. The results of this trial would ultimately help us choose the~     most effective treatment of resectable esophageal cancer and hopefully improve survival.~   "
126357|NCT01400659|"~     The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein~     (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus~     in sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For~     fat/protein counting the model used by Pankowska et al. will be applied.~   "
126167|NCT01404130|"~     This prospective study tested the effects of isotretinoin in a cohort of patients receiving~     standard therapy for acne vulgaris. Subjects completed questionnaires and standardised~     computer based cognitive testing using CANTAB to test for cognitive effects particularly on~     learning and memory. Test were conducted before starting isotretinoin, after 3 months and~     again a month after finishing therapy. This was carried out as a pilot study to~        1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will~          result in a decline in learning and memory as measured using the CANTAB series of test.~        2. Generate data for sample size calculation for a larger study to determine the changes~          in memory over time in drug and control group~        3. Test of CANTAB, questionnaires and data collection forms~        4. Select most appropriate outcome measures~        5. Identify therapy sensitive cognitive tasks which would be used in future functional~          brain imaging studies It was not considered to randomise subjects to placebo.~   "
126168|NCT01404117|"~     A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod~     (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in~     relapsing remitting multiple sclerosis (RRMS) subjects~   "
126169|NCT01404104|"~     Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by~     starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink~     the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to~     the surgical removal of the entire kidney or a portion of the kidney that is involved by the~     tumor.~   "
126170|NCT01404091|"~     The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ~     peptide (NOP) receptor occupancy (RO) in healthy subjects.~   "
126171|NCT01404078|"~     This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy~     tolerability of low strength Polycap versus two doses of low strength Polycap in patients~     with stable cardiovascular disease in reducing blood pressure and LDL.~      To evaluate the tolerability and safety of low dose potassium supplementation compared to~     placebo in patients with stable cardiovascular disease.~      Approximately 500 patients are planned to be randomized.~   "
126172|NCT01404065|"~     The purpose of this study is to investigate the effects of Transcranial Direct Current~     Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal~     cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects~     with spinal cord injury when compared to sham stimulation. The investigators will also~     measure changes in EEG data (alpha and beta frequencies) as well as motor cortex~     excitability.~   "
126173|NCT01404052|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize~     that there will be a decrease in pain levels with active stimulation, when compared to sham~     stimulation. Before, during and after stimulation, the investigators will measure and assess~     changes intracranial blood flow with transcranial ultrasound.~   "
126174|NCT01404039|"~     The purpose of this study is to investigate the effects of different types of interventions~     (motor learning, somatosensory learning, mental imagery, observation, and tDCS) on the~     perception of pain and motor cortex excitability in healthy male subjects. This is an~     exploratory study of healthy subjects only.~   "
126175|NCT01404026|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The~     investigators hypothesize that the active tDCS group will show a significant pain/itch~     reduction when compared to sham stimulation.~   "
126176|NCT01404013|"~     This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone~     or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).~      The investigators hypothesize:~        1. Cough score and cough reflex sensitivity will be improved after treatment with~          montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.~        2. Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have~          better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while~          MON, is comparable to symbicort.~   "
126177|NCT01404000|"~     The purpose of this study s to determine whether treatment with Iodinated Active Charcoal~     can improve lung function and physical capacity in patients with chronic obstructive lung~     disorders. The rational for the study is the observation that COPD patients have an~     increased tissue load of mercury interfering with the function by NeuroEpithelial Endocrine~     (NEE) cells in the respiratory tract. Mercury binding to these NEE cells leads to an~     increased smooth muscle tonus and a reduced response to bronchodilator treatment. Initial~     observational data have shown an improved lung function and improved functional capacity~     after treatment motivating a larger placebo controlled POC study~   "
126178|NCT01403987|"~     The investigators hypothesize that there is significant variability in management of~     patients with ascites despite guidelines provided by the American Association for the Study~     of Liver Diseases, the professional organization most involved with management of liver~     patients. This variability may be attributable to knowledge deficits, skill limitations, or~     reflect systems-issues that limit the ability of a care provider to implement the clinical~     guidelines (time constraints, inadequate supervision, availability of appropriate equipment,~     and obtaining consent for non-emergent procedures). This variability does a disservice to~     the patients being treated, and results in trainee development of habits that are not~     evidence based. There are simple teaching tools available that may improve learning and~     retention of evidence based practice. Using these tools should result in more consistent~     appropriate patient care, improve patient outcomes, and provide better education to our~     trainees.~      The purpose of this study is threefold: 1. To improve medical house-staff's technical~     performance of and comfort level with paracentesis; 2. To improve adherence to professional~     organization guidelines and to determine if this in fact improves clinical outcomes; 3. To~     evaluate efficacy of three teaching interventions in inpatient medicine trainee rotations.~   "
126395|NCT01401309|"~     This study is to examine if there is improved sensitivity in detecting hepatic lesions using~     respiratory gating and if there is an improvement in confidence defining lesions as benign~     or malignant.~   "
126185|NCT01403896|"~     Stem cells can be transplanted from a healthy donor to a patient to combat blood cancers and~     other disorders. This process is called stem cell transplantation. Stem cells normally live~     in the bone marrow. A bone marrow transplantation (BMT) is when the bone marrow is directly~     transplanted into a patient. However, stem cells can also be stimulated to move from the~     bone marrow to the blood where they can be collected, a process is called mobilization. When~     these stem cells are transplanted it is called peripheral blood stem cell transplantation~     (PBSCT). Both stem cell sources are used for different reasons, but PBSCT is much more~     common.~      There is considerable debate as to which stem cell source, BMT or PBSCT, is optimal. There~     are differences between the two sources in important transplant outcomes. The stem cell~     product that is transplanted, also called the stem cell graft, contains more than just stem~     cells. Results from studies suggest that the variation in the cells with grafts may account~     for the variation in outcomes. Preliminary data from a recent study conducted by the~     Canadian Blood and Bone Marrow Transplant Group has associated relative frequencies of~     particular cell populations with leukemic relapse and another important outcome called graft~     versus host disease (GVHD). While the later essentially equates to a failed transplant, the~     former is the most common and devastating complication of stem cell transplantation.~      The only drug used to mobilize stem cells into the blood of health donors for collection is~     G-CSF. However there is a new mobilization drug recently approved called plerixafor. This~     drug is able to mobilize stem cells when G-CSF has failed and pre-clinical studies suggest~     that it may produce a superior stem cell graft to G-CSF alone. There is little information~     available, besides safety and efficacy data, about the effects that plerixafor has on the~     stem cell graft of normal healthy donors.~      This study will compare the stem cell graft in normal healthy donors following plerixafor~     mobilization versus plerixafor and G-CSF mobilization. Specifically, they will look at the~     cell populations that have been previously correlated with important transplantation~     outcomes like relapse and GVHD. The investigators suspect that the stem cell graft mobilized~     by plerixafor and G-CSF will provide a superior graft to that mobilized by plerixafor alone.~   "
126186|NCT01403883|"~     In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of~     postoperative anastomotic leakage. The aim of the study was to assess the benefit of an~     optimal care, i.e., both psychological and enterostomal therapy care.~   "
126187|NCT01403870|"~     The purpose of this research study is:~        1. to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal~          Regions) the electrical signals made by the muscles in the lower back during the~          treatment of the low back pain, and~        2. to study the changes which take place in these muscles with treatment. The device is~          non-invasive which means nothing is put into your body. The CERSR® pad is an adhesive~          (sticky) array (ordered rows) of electrodes.~      The investigators hope to find information about the quality of the muscles' electrical~     signals in reaction to injury causing back pain, which will improve understanding of the~     nature of back pain and back injury. The investigators also hope to improve treatment by~     creating a simple test, which will tell us objectively (through computerized measurement)~     whether the treatment is helping.~   "
126188|NCT01403857|"~     The specific aims of the Grain Study are to determine if sensitivity to bitter taste affects~     the liking and acceptability of different grain products, to determine if exposure to~     different types of grain products, over a period of 6 weeks, changes liking and~     acceptability and to determine if the gut microbiota, bacterial fermentation products, or~     gastrointestinal function changes with consumption of whole grains or refined grains.~   "
126189|NCT01403844|"~     The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy~     for assessing vegetable and fruit consumption.~   "
126190|NCT01403831|"~     The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to~     Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a~     technologically simple solution using unidirectional daily text messages to consisting of~     educational materials, trivia questions and challenges promoting healthy lifestyle choices~     and reminders to check blood sugar, take medications and go to clinic appointments. The~     investigators believe TExT-MED will improve health outcomes including blood glucose control~     and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use~     and can be quickly adapted to other practice environments.~   "
126191|NCT01403818|"~     This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide~     calcium hydrate in healthy volunteers.~   "
126192|NCT01403805|"~     Prospective study comparing the effects of interventions (combined oral care and~     pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the~     survival rate from pneumonia.~   "
126193|NCT01403792|"~     The purpose of this study is to assess the safety and tolerability of intravaginal~     administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1~     will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to~     14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or~     placebo. A safety review will take place before subjects in Groups 2 and 3 receive study~     drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical~     inspections will be performed to determine what effect, if any, the study drug has had on~     the site of administration. Adverse event data will be collected throughout the trial.~   "
126194|NCT01403779|"~     Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and~     normofractionated radiotherapy after breast-conserving surgery. However, the treatment in~     these studies was carried out with conventional techniques and not with the modern IMRT.~     Also the evaluation of quality of life and cosmetic outcome were not standardized.~      This study is a two-arm prospective study comparing normofractionated and hypofractionated~     radiotherapy in patients with breast cancer using tangential IMRT techniques.~      The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint~     is the patients' quality of life.~      Patients to be included are breast cancer 60 years old patients or older with tumour stages~     pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast~     cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15~     fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25~     fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).~      In both groups, a tangential intensity-modulated radiation technique aiming to achieve~     optimal dose homogeneity is applied.~      Since higher single radiation dose to the heart can lead to higher morbidity and/or~     mortality, patient stratification according to the diseased side was adopted where the~     left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore~     there is no randomization.~      For classification and grading of adverse cosmetic events, the Common Toxicity Criteria~     (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of~     life is to be documented with two standardized, validated questionnaires QLQ C30 and BR23~     of the EORTC (European Organization for Research and Treatment of Cancer). The~     questionnaires are to be filled by the patients themselves at different time points during~     the study period.~      A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of~     around 20% is expected after 2 years.~      Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power~     of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the~     need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated~     therapy).~   "
126210|NCT01403558|"~     The aim of this randomized controlled trial is assess the effect of a psychological based~     treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese~     patients undergoing bariatric surgery.~      Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational~     interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors~     and increase pre-surgical intrinsic motivation for lifestyle changes.~   "
129013|NCT01366781|"~     The study hypothesis is that the release of gut hormones is increased proportionally to~     caloric load in each meal. Three different meals with different meal size will therefore be~     served and gut hormones determined.~   "
126195|NCT01403766|"~     Glomerular filtration rate (GFR) is the best known measurement of kidney function. Serum~     creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient,~     inexpensive test that involves a single blood draw with rapid results. However, creatinine~     has several limitations because its blood level is dependent on age, body mass, and sex. One~     of the gold standards for measuring GFR is plasma clearance of an IV injected agent,~     iohexol. It has been found to be safe and nontoxic in prior studies, but is not practical in~     the clinical setting due to the need for several timed blood draws. Recent studies have~     investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also~     involves only a single blood draw, and has less confounding factors than creatinine since it~     is independent of age, body mass, and sex. Currently, it remains controversial whether~     cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date,~     there has not been a large prospective cohort study to compare cystatin C and creatinine in~     pediatric kidney transplant patients who are on maintenance immunosuppression~     (anti-rejection drugs). Accurate measurement and early detection of deterioration of GFR is~     critical in the care of this patient population. The purpose of this study is to assess the~     accuracy of estimating GFR by using cystatin C versus creatinine clearance equations when~     compared to the surrogate gold standard of iohexol GFR in pediatric renal transplant~     patients.~   "
126196|NCT01403753|"~     The purpose of this study was to measure and quantify children's beliefs about the satiating~     properties (i.e. expected satiation)of snack foods. The investigators predicted that~     children who were especially familiar with snack foods would expect them to deliver greater~     satiation.~   "
126197|NCT01403740|"~     Turkish Acquired Haemophilia Registry is a database in which information about clinical~     features and therapeutic management of acquired haemophilia is collected in Turkey.This is a~     multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for~     acquired haemophilia. Patients will be registered and the response to different therapies,~     details of each bleeding episode and the outcome of haemostatic and immunosuppressive~     therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to~     FVIII or other factors and treated for acquired haemophilia can be entered on the registry.~     Patients will be treated according to local practice. No additional tests or procedures are~     required by the registry. The retrospective period will not be time-limited and data will be~     collected from those recorded in the hospital notes. The prospective period will begin in~     September 1.2011, and will last for two years.~   "
126198|NCT01403727|"~     The purpose of the trial is to evaluate the differences between PercuNav assisted and~     unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.~      This prospective, randomized, controlled trial will compare the use of electromagnetic~     tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided~     procedure alone.~   "
126199|NCT01403714|"~     This study will address the role of percutaneous renal intervention for a hemodynamically~     significant renal artery stenosis in patients with heart failure exacerbations. Current~     guidelines suggest evaluation for renal artery stenosis in patients with pulmonary edema or~     heart failure that cannot be attributed to poor left ventricular function. While case series~     have suggested benefit to percutaneous intervention in patients with heart failure, no~     randomized study has addressed the potential benefit of renal stenting for heart failure~     patients. Two large randomized trial of renal stenting for hypertension or poor kidney~     function failed to show benefit in patients with intermediate renal artery lesions. No~     evaluation of the potential hemodynamic significance of the lesions was performed prior to~     randomization. The investigators will enroll patients with heart failure exacerbations not~     attributable to declining left ventricular function, valvular disease, acute coronary~     syndrome, or heart transplant rejection, who on non-invasive imaging appear to have renal~     artery stenosis. After routine invasive assessment, including renal angiography and~     pressure-wire assessment, patients with hemodynamically significant renal artery stenoses~     will be randomized to stent implantation or medical therapy. Patients will then be followed~     to determine whether stenting impacts cardiac mortality or hospitalization for heart~     failure.~   "
126200|NCT01403701|"~     i) The primary objective of this study is to determine if physical therapy improves~     postoperative quality of life in participants following vaginal reconstructive surgery for~     pelvic organ prolapse and urinary incontinence.~      ii) Secondary objectives include:~        1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse~          symptoms) in participants undergoing physical therapy compared to standard~          postoperative care~        2. Comparing sexual function in participants undergoing physical therapy compared to~          standard postoperative care;~        3. Comparing postoperative pain scales, and activity assessment in participants undergoing~          physical therapy compared to standard postoperative care;~        4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in~          participants undergoing physical therapy compared to standard postoperative care.~   "
126201|NCT01403688|"~     Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from~     infertility treatments may increase breast cancer risk, but there has not been enough~     research to know for sure. Researchers want to use a method of taking breast tissue cells~     from women who are having infertility treatment. The breast tissue cells might show changes~     that would indicate an increased risk of cancer. The method of taking the breast tissue~     cells is called Fine Needle Aspiration (FNA).~      The purpose of this study is to examine the changes in breast tissue, in women at high risk~     of breast cancer who are being treated with controlled ovarian hyperstimulation.~   "
126211|NCT01403545|"~     Aim of the present study is:~        -  To evaluate the safety and tolerability of increasing doses of intravenous liposomal~          Curcumin in healthy subjects by means of adverse events, vital signs and safety~          laboratory assessments.~        -  To investigate the pharmacokinetics of increasing doses of intravenous liposomal~          Curcumin in healthy subjects.~   "
126326|NCT01402050|"~     OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled~     release prostaglandin (Cervidil™) for cervical ripening in term and near term women~     presenting for labor induction.~      HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley~     catheter will decrease the mean time from induction to delivery by six hours compared to~     controlled release prostaglandin (Cervidil™).~   "
126202|NCT01403675|"~     Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors~     may find that they are not able to produce female hormones, and they may not be able to have~     a child. Scientists are trying to find ways to help cancer survivors regain their hormonal~     function and possibly get pregnant, if they desire. Scientists have developed a method where~     ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back~     into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue~     back into her body is called ovarian autotransplantation.~      Ovarian autotransplantation is a very new technique, and there have only been a small number~     of women who have had this procedure. So far, only five babies in the world have been born~     using this technique.~      The purpose of this study is to learn more about ovarian autotransplantation. Scientists~     hope to find better ways to use this method to help a woman's ovaries start working again~     after chemotherapy. If the ovaries start working again, it might be possible to have a baby.~   "
126203|NCT01403662|"~     Long-term studies have emphasized that depressive symptoms and episodes account for majority~     of the illness burden experienced by individuals with bipolar disorder (BD). Previous~     studies have shown that blood levels of proteins called pro-inflammatory cytokines are~     abnormal in individuals with bipolar depression. The investigators hypothesize that~     preventing the production or release of pro-inflammatory cytokines will result in~     improvement of depressive symptoms in individuals with bipolar depression. Minocycline is a~     medication that inhibits the activation of immune cells (i.e. microglia) in the brain and~     reduces the production of pro-inflammatory cytokines. Treatment with minocycline has been~     shown to have antidepressant-like effects in animal studies and improve symptoms of~     individuals with schizophrenia. In this study, minocycline (100 mg twice a day) will be~     administered for 8 weeks to determine if it is an efficacious antidepressant for individuals~     with bipolar depression.~   "
126204|NCT01403649|"~     Beginning with the 2009-2010 season, influenza vaccine is universally recommended for~     children age 6 months to 18 years old, placing extra burden on health care providers across~     the U.S. The focus of this study is to develop new strategies and implement existing~     evidence-based strategies to enhance influenza immunization in these children. The~     intervention will involve collaboration from different types of primary care providers, the~     Colorado Immunization Information System (CIIS), public health departments and visiting~     nursing services (VNA). It will be designed and implemented by those involved with delivery~     with a focus on sustainability after the completion of the study. Parental input will be~     gathered during the planning year through focus groups to assist in developing the~     intervention. Qualitative assessments and examination of processes during the first year of~     implementation will guide modifications during the second implementation year in order to~     assure sustainability. Primary outcome measures in the intervention and control groups: 1)~     increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year~     compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the~     rate of children 6 mo.-18 yr. who were fully immunized (received all required influenza~     injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12~     yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)~   "
126205|NCT01403636|"~     Primary Objective:~      - To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR)~     in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle~     cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small~     lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)~      Secondary Objectives:~        -  To assess duration of response, progression free survival (PFS), and proportion of~          patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or~          DLBCL treated with SAR245409~        -  To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL~          or DLBCL~        -  To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with~          MCL, FL, CLL/SLL or DLBCL~   "
126206|NCT01403623|"~     The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared~     to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing~     hyperthermia (> 37.5 degrees C).~   "
126207|NCT01403610|"~     The Primary Objectives are:~        -  To determine the extent by which TH-302 is able to penetrate the blood brain barrier~          and affect tumor tissue~        -  To assess the safety of single dose TH-302 in patients with high grade glioma~          undergoing surgery~        -  To assess the safety of TH-302 in combination with bevacizumab for patients with high~          grade glioma~        -  To determine the MTD and DLT(s) of TH-302 in combination with bevacizumab~      The Secondary Objectives are:~      To determine the progression-free survival with or without debulking craniotomy for patients~     treated with combination bevacizumab and TH-302 following recurrence on single agent~     bevacizumab~   "
126208|NCT01403597|"~     The study is designed to determine the safety, efficacy, patient comfort and patient~     satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved~     under 510k clearances. The evaluations will include skin condition, physician/subject~     improvement assessment, and subject comfort and satisfaction score by questionnaires.~   "
126209|NCT01403571|"~     Canadian statistics indicate that the incidence of obesity is increasing and that the~     occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy~     weight, making weight control in this population particularly relevant. Preliminary clinical~     data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce~     after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite.~     Its use may therefore have potential implications in long-term weight management, while~     improving diabetes.~      The objective of this research (weight loss) is to evaluate whether adding Salba to an~     energy reduced diet for six months will result in greater weight loss compared to control in~     overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or~     obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted~     diet and their regular diabetes therapy together with regular exercise. Participants were~     randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat~     bran control supplement matched for energy. The effect of the supplements on weight-loss~     (including waist circumference, % body fat) and glucose control (A1c, fasting glucose~     levels) will be assessed. In addition, related outcomes such as low-grade body inflammation,~     hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT~     and prothrombin time) and satiety scores were evaluated.~      Modest weight loss has been associated with improved glucose control in individuals with~     type 2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight~     loss and improve glycemic control and CVD risk factors compared to such a diet alone. Salba~     may also promote maintenance of weight loss and therefore help prevent weight gain by~     providing feelings of fullness that reduce appetite. In light of the high incidence of~     obesity in individuals with diabetes, Salba grain may be a useful addition to the diet.~   "
126212|NCT01403532|"~     The traditional therapy for induction of spermatogenesis in male hypogonadotropic~     hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until~     pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance,~     the investigators raise a new sequential therapeutic approach which can make the treatment~     more economic and tolerable. The zinc supplement will be also evaluated in patients in this~     study. This randomized, parallel, open, and multi-center study will compare the efficacy of~     traditional therapy with new therapy and evaluate the safety of the new protocol.~   "
126213|NCT01403519|"~     Tau pathology and tangles have been associated with cognitive dysfunction causing~     neurodegeneration. AD, the most abundant tauopathy is characterized by amyloid plaques and~     tau tangles. An abundance of tau inclusions, in the absence of amyloid deposits, defines~     Pick's disease (frontotemporal lobar degeneration), progressive supranuclear palsy (PSP),~     corticobasal degeneration (CBD) and other diseases including frontal atrophy associated with~     cognitive clinical dysfunction of frontal dysexecutive syndrome, progressive nonfluent~     aphasia and semantic dementia as recently reviewed (Gozes 2010). It is the investigators aim~     to follow other protein expression [as per recent publications (Marksteiner et al., 2011)]~     in blood and CSF samples from those tauopathies.~      Significance: Results should establish the possibility of using tau and other proteins as~     markers for early detection and disease progression in FTD, also in comparison to~     Alzheimer's disease (AD).~   "
126214|NCT01403506|"~     The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on~     biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated~     Lipocalin (NGAL) and Intereleukin 18 (IL18).~   "
126215|NCT01403493|"~     In this randomized controlled study in patients with irritable bowel syndrome (IBS), the~     investigators plan to compare the effects of a multidisciplinary structured patient group~     education with a compressed nurse based structured patient group education. The effects of~     the interventions on gastrointestinal (GI) and psychological symptom severity, knowledge and~     quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12~     months after the intervention.~   "
126216|NCT01403480|"~     Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is~     primarily surgical with the goal of excising the growth in its entirety. When pathology~     results show that this has not been achieved, a re-excision is routinely performed. This~     study examines retrospectively the percentage of re-excisions of BCC that actually proved to~     be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare~     Campus and Zvulun Community Medical Center during the years 2008-10.~   "
126217|NCT01403467|"~     This current study aimed to demonstrate the effectiveness of the addition of CPAP to the~     current conventional therapy in terms of airway obstruction improvement in acute asthma~     patients.~   "
126218|NCT01403454|"~     This study involves Chronic Kidney Disease patients that must choose the type of dialysis~     therapy they ultimately wish to perform. These patients receive education regarding dialysis~     types from nurses and Nephrologists at a Kidney Function Program. The investigators have~     developed a web-based Interactive Health Communication Application that could provide more~     education and support to patients about their dialysis choices. The investigators will~     compare patients that will receive usual care dialysis education versus patients that will~     receive additional education through this web-based application. The investigators feel that~     this tool may increase the proportion of patients who start home dialysis, which offers~     advantages such as improvement in quality of life and deceased overall healthcare costs,~     over hospital hemodialysis.~   "
126219|NCT01403441|"~     This study is designed to evaluate the safety and effectiveness of an investigational~     procedure for treating people with treatment resistant bipolar depression. Precise dose~     delivery of radiation to the predetermined targets in the brain will be accomplished with~     known Cyberknife stereotactive radiosurgery methods.. This technology is considered to be~     noninvasive (does not physically invade your body). We will be studying if the Cyberknife~     influences the sensitivity of certain nerves of your brain. Although many clinical~     treatments for psychiatric conditions have been done using stereotactive radiosurgery, the~     present study is experimental, because we are seeking to use more moderate doses of~     radiation that are intended not to destroy any brain cells, but to normalize or modulate~     their function.~   "
126220|NCT01403428|"~     Status Asthmaticus is recognized as a common cause of morbidity in children in the United~     States (CDC). In recent years, hospitalization rates have reached an all time high. This~     study will evaluate the effect of early use of noninvasive positive pressure ventilation~     (NPPV) in children admitted to the pediatric intensive care unit (PICU) with moderate to~     moderately severe status asthmaticus to test the hypothesis that early initiation of NPPV~     plus standard of care will result in decreased length of PICU stay, significant improvement~     in clinical asthma score (CAS) and reduced patient care costs when compared to standard of~     care alone.~   "
126221|NCT01403415|"~     This phase I trial studies the side effects and the best dose of temsirolimus when given~     together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and~     pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or~     non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone,~     mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment~     for acute lymphoblastic leukemia or non-Hodgkin lymphoma.~   "
126273|NCT01402739|"~     Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on~     several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants,~     and postoperative chest tube output. Allogeneic blood transfusion is associated with~     transfusion reactions, infection transmission, and postoperative morbidity and mortality.~     The aim of this study is to investigate, whether cardiac surgery patients have a reduced~     postoperative chest tube output and transfusion need when using a point-of-care guided~     transfusion algorithm compared to standard of care transfusion protocols.~   "
126274|NCT01402726|"~     The purpose of this study is to observe the incident of composite cardiovascular events~     after renal sympathetic modification using THERMOCOOL® catheter in patients with heart~     failure, and evaluate safety and efficacy of the intervention.~   "
126222|NCT01403402|"~     The Congenital Muscle Disease Patient and Proxy Reported Outcome Study (CMDPROS) is a~     longitudinal 10 year study to identify and trend care parameters, adverse events in the~     congenital muscle diseases using the Congenital Muscle Disease International Registry~     (CMDIR). The CMDIR registers individuals with congenital muscular dystrophy, congenital~     myopathy and extends to the limb girdle and late onset spectrum for both disease groups. The~     CMDIR was created to identify the global congenital muscle disease population for the~     purpose of raising awareness, standards of care, clinical trials and in the future a~     treatment or cure. The registry includes demographic, disease specific and diagnostic~     questions. Key care parameters are surveyed longitudinally by proxy and/or patient report,~     confirmed by medical records. Genetic reports are curated by a board certified genetic~     counselor with support provided to families to pursue molecular confirmation through~     referrals to national centers of excellence.~      Study hypothesis:~        1. To use patient and proxy reported survey answers and medical reports to build a~          longitudinal care and outcomes database across the congenital muscle diseases.~        2. To generate congenital muscle disease subtype specific adverse event rates and~          correlate with key care parameters.~   "
126223|NCT01403389|"~     The purpose of this study is to determine if Eculizumab is safe and effective in the~     prevention of delayed graft function following deceased donor kidney transplantation.~   "
126224|NCT01403376|"~     Primary Objective:~      Assess the antibody response to influenza vaccine in patients with relapsing form of~     multiple sclerosis (RMS) treated with teriflunomide compared to a reference population.~      Secondary Objectives:~        -  Assess the effect of teriflunomide on immunoglobulin levels;~        -  Assess the safety of influenza vaccination in patients with RMS treated with~          teriflunomide.~      The reference population was defined as multiple sclerosis (MS) patients with a stable~     treatment with interferon-β-1. Antibody response was measured using hemagglutination~     inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1,~     and B as present in the influenza vaccine used.~   "
126225|NCT01403363|"~     Fentanyl is considered a potent synthetic opioid widely used in anesthesiology, for short~     and long-term pain management, and for sedation. The fentanyl patch is constructed like a~     matrix, a system based on a polyacrylate net with fentanyl that attaches directly onto the~     skin. The doses available today are from 12µg/h, 25, 50, 75, to 100 µg/h. Despite the~     variable doses available, often in certain patients as the elderly or children, there is a~     need for slower titration than the 12 µg/h currently available.~      In this study, the investigators aim to evaluate pain control and to examine the blood~     fentanyl concentration of patients on a fix dose of fentanyl patch up to 100 µg/h every two~     or three days, and compare it with pain control and concentration levels obtained from a~     similar dose patch, but after cutting the patch into two.~      The study will take place at the pain clinic of Clalit Health Services-South District~     (CHS-SD), and the Negev home palliative care unit. In CHS-SD there are approximately 300~     patients treated regularly with opioids and about 120 patients in the home palliative care~     unit. A sample of 95 patients will be recruited. Once consent form is signed, blood samples~     will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from~     the first sample, and at least 36 hours after replacing the cut patch. Pain management will~     be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI~     questionnaire, and rescue doses used before and after the cutting of the patch. The blood~     samples will be transferred to the laboratory for testing of fentanyl concentration levels.~   "
126226|NCT01403350|"~     Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid~     diagnostic tests could improve treatment of malaria at the local community level. Deployment~     of these tests is, however, a considerable cost. The aim of the study is to evaluate their~     effect on improving treatment of fever when used by Community Health Workers in Afghanistan.~     In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard~     training and support will improve the accuracy of treatment applied to fever by community~     health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of~     the study, the hypothesis is that the accuracy of treatment can be improved by additional~     training and supportive interventions given to community health workers compared to those~     who have only had standard training.~   "
126227|NCT01403337|"~     Vascular surgery is considered a high-risk operation with an anticipated risk of major~     cardiovascular complications in excess of 5%. The occurrence of a cardiovascular~     complication after surgery carries a long-term higher mortality risk. The main objective of~     this investigation is to reduce the proportion of patients having major cardiovascular~     complications during surgery through a clinical protocol of remote preconditioning that is~     safe, effective and reproducible.~   "
126228|NCT01403324|"~     Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131~     administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to~     treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the~     pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels~     is to perform intramuscular injection of recombinant human TSH, a hormone produced~     pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the~     metastases is similar after rhTSH administration or after thyroid hormone withdrawal.~   "
126229|NCT01403311|"~     This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in~     removing malignant brain tumors during surgery.~   "
126230|NCT01403298|"~     The purpose of this project is to compare the effect of a family-based HIV prevention~     program to the effect of an adolescent-only health promotion program on adolescent HIV risk~     and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode~     Island Family Court.~   "
126275|NCT01402713|"~     The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of~     'GC1107' administered intramuscularly in healthy children~   "
126276|NCT01402700|"~     The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming~     the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System~     for the treatment of stenotic, restenotic or occluded lesions in the common and external~     iliac artery.~   "
126277|NCT01402687|"~     The goal of this study is to gain new knowledge about genetic risk factors thta may affect~     the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus~     following HSCT. The study seeks to understand if different forms of genes result in an~     increased risk of sores in the mouth and esophagus.~   "
126231|NCT01403285|"~     BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a~     cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells~     without harming normal cells.~      IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides~     (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T~     cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific~     T-cell response against tumor cells leading to decreased likelihood of immune evasion of the~     tumor by down-regulation of target antigens.~      PURPOSE: The primary objective of this study is to determine the safety and tolerability of~     IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor~     (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows~     sufficient immunogenicity in these patients.~      ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and~     have stable disease following at least 4 cycles of adjuvant temozolomide.~   "
126232|NCT01403272|"~     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will~     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and~     shearing among residents of Nursing Homes.~   "
126233|NCT01403259|"~     The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus~     oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal~     carcinoma.~   "
126234|NCT01403246|"~     This is a phase I-II multicenter, open label study in previously untreated and elderly~     patients (> 60 years) with CLL ,which includes 2 sections:~      Induction phase with Chlorambucil and Lenalidomide (CL):~        -  Phase 1: a non-comparative phase aimed at defining the MTD of lenalidomide given in~          combination with chlorambucil and the efficacy and safety of the lenalidomide and~          chlorambucil combination;~        -  Phase 2: a non-comparative phase aimed at defining the overall response rate of~          lenalidomide given at the MTD in combination with chlorambucil.~      Maintenance versus clinical observation:~      -A comparative phase including lenalidomide or clinical observation aimed at defining the~     benefit of lenalidomide given as maintenance therapy.~   "
126235|NCT01403233|"~     The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male~     subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to~     compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68~     mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the~     study compounds will be determined.~      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by~     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators~     do not claim that this supplement is meant to treat any ailment.~   "
126236|NCT01403220|"~     The primary objective of this study is to compare the efficacity of hemodiafiltration and~     hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary~     objectives include comparing urea clearance, filter duration, and %down-time, between the~     two techniques.~   "
126237|NCT01403207|"~     This pilot study will use tissues and fluids that are normally discarded during the course~     of total knee replacement surgery to investigate potential sex differences in knee~     osteoarthritis. Basic clinical demographic information will be obtained as well as~     preoperative functional and pain assessment scores, functional tests, and pressure pain~     threshold measurement. The purpose of the study will be to investigate if any sex~     differences can be identified in these tissues and to investigate if there appears to be any~     relationship between these differences and functional scores and tests.~   "
126238|NCT01403194|"~     The hypothesis for this study is that children with sleep disordered breathing will benefit~     from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway~     Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin~     resistance.~      The CPAP machine delivers a predetermined level of pressure. It releases a stream of~     compressed air through a hose to the nose mask and keeps the upper airway open under~     continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as~     a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles~     during sleep. This machine helps to increase the oxygen flow by keeping the airway open.~      The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure~     (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory~     Positive Airway Pressure (EPAP) during exhalation.~   "
126239|NCT01403181|"~     Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess~     whether therapy can induce restoration of the T cell function and to what extent this~     recovery can be achieved~   "
126240|NCT01403168|"~     This is an open, prospective, controlled, randomized, comparative study with 2 arms.~      The purpose of the study is to assess the efficacy of osteopathy after breast surgery.~      80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will~     be followed during one year.~   "
126241|NCT01403155|"~     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several~     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well~     tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which~     includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will~     be delivered via electroporation (EP) which uses the CELLECTRA constant current device to~     deliver a small electric charge following injection, since animal studies have shown that~     this delivery method increases the immune response to vaccine. The vaccine will be given to~     up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that~     a booster dose with INO-3401 + EP will be well tolerated and immunogenic.~   "
126278|NCT01402674|"~     Phentermine, an amphetamine congener, is the most widely used anti-obesity drug in the U.S.~     Although phentermine is the agent-of-choice among physicians specializing in obesity~     treatment, the use of this drug for obesity treatment by other physicians has long been~     curtailed because misapprehensions regarding phentermine safety. Concerns of~     phentermine-induced adverse cardiovascular reactions and of phentermine-induced addiction~     are two fears that have had a profound negative impact on phentermine prescribing. Although~     warnings of high incidence rates of adverse cardiovascular and psychiatric effects are~     included in FDA labeling and are often repeated in published reviews, the few clinical~     reports in the peer-reviewed medical literature of such adverse effects are anecdotal. Fear~     of phentermine adverse effects does not inhibit the use of phentermine by obesity treatment~     specialists. A 2008 survey of prescribing practices found that 98% of bariatric medicine~     specialists used pharmacotherapy in treating obesity and that 97% of those prescribed~     phentermine as their first choice.~      The fear that phentermine has addiction potential appears to be a factor influencing~     curtailment of use. At the time that phentermine was approved in 1959 the expectations were~     that it would prove to be addicting, although perhaps less so than amphetamine. These~     expectations were based on the chemical structural similarities between phentermine and~     amphetamine and on evidence in rats that phentermine stimulated spontaneous activity. No~     evidence suggesting the drug had human addiction potential appeared in clinical trials~     conducted prior to approval.~      After 52 years of use there is no evidence in the peer-reviewed medical literature to~     support the hypothesis that phentermine has significant human addiction potential. Research~     in addiction medicine has undergone significant development in the last 50 years. Concepts~     of addiction have shifted from an early focus on tolerance and withdrawal to a current~     emphasis on the psychological components of dependence. Drug addiction has been redefined as~     drug dependence and standardized diagnostic criteria have been adopted for drug abuse,~     dependence and withdrawal. Psychometric testing methods have been developed, validated, and~     applied clinically for measurements of dependence, drug craving, and withdrawal for a wide~     variety of substances of abuse including cocaine, heroin, and amphetamine.~      Until recently, none of these addiction medicine metrics had been used to study the~     addiction potential of phentermine. Presumably, since phentermine is an amphetamine~     congener, any clinical characteristics of dependence or withdrawal should mimic those of~     amphetamine dependence or withdrawal. One recent retrospective study investigated symptoms~     occurring when patients treated with long-term phentermine in a weight management program~     abruptly ceased taking phentermine. The study found that patients on long-term phentermine~     who ceased phentermine abruptly by their choice did not have an amphetamine-like withdrawal~     symptom complex. Significantly there was no evidence of phentermine cravings. Further~     investigation is warranted.~      The addiction potential of a drug may be investigated by measuring the drug's propensity to~     induce dependence, to induce cravings for the drug, and for cessation of the drug to induce~     characteristic withdrawal symptoms. In the case of amphetamine withdrawal symptoms appear~     very quickly reaching a maximum at 48 hours after drug cessation.~      In this prospective study the addiction potential of phentermine will be assessed with~     validated psychometric scales to examine patients who have taken phentermine long-term for~     two years or more. Patients who have taken phentermine for 7 to 14 days will also be~     assessed. Participating patients who have taken phentermine long-term in this study will be~     asked to interrupt phentermine therapy for 48 hours to participate in the study. Scale~     examinations will be conducted at 24 and at 48 hours after drug cessation.~      Hypotheses~        1. Long-term phentermine-treated (LPT) patients do not develop phentermine dependence or~          cravings.~        2. LPT patients who cease taking phentermine abruptly do not experience amphetamine-like~          withdrawal symptoms.~      Specific Aims~        1. To compare the severity of phentermine dependence and craving between LPT patients and~          acute phentermine-treated (APT) patients~        2. To compare the severity of stimulant withdrawal symptoms before and after phentermine~          cessation in LPT patients.~        3. To examine the prevalence of phentermine dependence in LPT patients~   "
126337|NCT01401907|"~     The purpose of this study is to compare two types of care - standard oncology care and~     standard oncology care with early palliative care (started soon after diagnosis) to see~     which is better for improving the experience of patients and families with advanced lung and~     non-colorectal GI cancer. The study will use questionnaires to measure patients' and~     caregivers' quality of life, mood, coping and understanding of their illness.~   "
126773|NCT01396213|"~     A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and~     safety of Larazotide Acetate in the treatment of patients with celiac disease who have~     persistent symptoms despite being on a gluten-free diet.~   "
126242|NCT01403142|"~     Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen~     in the coronary arteries of patients who have received heart transplantation. It is a major~     cause of morbidity and mortality in patients after heart transplant. Little progress has~     been made in characterizing this disease process, with more sophisticated imaging allowing~     for more detailed analysis of CAV, superior stratification of transplant recipients is~     possible and earlier interventions can be performed if necessary to prevent mortality and~     graft loss.~      Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution~     then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart~     transplant using this high-resolution imaging modality. It is currently the standard care~     for patients post-heart transplant to receive annual coronary angiograms with close follow~     up. Patients will be imaged using OCT at the time of their routine annual angiogram, and~     will be re-imaged one year later at the time of the next annual angiogram or earlier if~     clinically indicated. The study goal is to better characterize CAV in vivo with OCT imaging~     and to try to identify patterns of the disease, including intra-coronary risk assessment.~   "
126243|NCT01403129|"~     Keratoconus (KC) is a corneal disease which will in many cases ultimately require corneal~     transplantation to maintain vision. Early detection, which is not possible with current~     technology, would allow early treatment and prevent severe damage to KC corneas~     inadvertently operated upon for correction of vision. Our aim is to combine measurements of~     different properties of the cornea to develop means for early detection of KC.~   "
126244|NCT01403116|"~     The purpose of this study is to determine the safety and efficacy of an oral testosterone~     undecanoate formulation for use as testosterone-replacement therapy in men with low~     testosterone.~   "
126245|NCT01403103|"~     This pilot clinical trial studies cholecalciferol in treating patients with colorectal~     cancer. The use of cholecalciferol may slow disease progression in patients with colorectal~     cancer.~   "
126246|NCT01403090|"~     The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central~     line catheter. The device is designed to be placed in the inferior vena cava via the femoral~     vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous~     system. The primary endpoint is freedom from serious adverse events (SAE), defined as death,~     symptomatic pulmonary embolism or major bleeding .~   "
126247|NCT01403077|"~     This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the~     treatment of subjects with de novo native superficial femoral artery lesions.~   "
126248|NCT01403064|"~     The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the~     course of oral mucositis in subjects with head and neck cancer receiving concomitant~     chemotherapy and radiotherapy~   "
126249|NCT01403051|"~     This study was done with people who were infected with HIV and needed to start treatment for~     their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will~     help prevent the bone loss that sometimes happens when people start HIV treatment. For this~     study, the following HIV treatment (or HAART) were provided in the form of a single tablet~     that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These~     drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common~     for people who are taking HIV drugs for the first time. The risks seen with this HIV~     treatment are the same that you would encounter when taking these drugs outside of the~     study. The lists of risks of this HIV treatment are included in this document because the~     drugs are provided by the study, not because the drugs are being tested. The purpose of the~     study is only to look at the impact of high doses of vitamin D and calcium in preventing~     bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).~   "
126250|NCT01403038|"~     This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects~     of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve~     and to assess the effect of elagolix on selected endocrine/hormone levels.~   "
126251|NCT01403025|"~     This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and~     type of SADRs (serious adverse drug reactions).~   "
126252|NCT01403012|"~     Metabolomics of systemic psoriasis treatment~   "
126253|NCT01402999|"~     This is a Hungarian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
126254|NCT01402986|"~     The purpose of this study is to determine whether the addition of tralokinumab to standard~     asthma medication is effective in the treatment of adults with asthma~   "
126255|NCT01402973|"~     The purpose of this pilot study is to determine whether it is feasible to conduct a~     randomized, controlled dietary intervention trial of high versus low dietary intake of~     advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the~     impact of high versus low AGE diet health parameters. The investigators hypothesize that it~     will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a~     pilot study involving 24 subjects.~   "
126256|NCT01402960|"~     The purpose of this study is to assess the effects of high-definition transcranial direct~     current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The~     investigators hypothesize that subjects will show a decrease in pain symptoms in the active~     anodal stimulation group when compared to sham stimulation.~   "
126257|NCT01402947|"~     This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR~     administered alone & in combination with MMX Mesalazine/mesalamine.~   "
126258|NCT01402934|"~     The investigators hypothesized that pulse pressure variation (PPV) could predict fluid~     responsiveness in spontaneously breathing patients undergoing anesthesia induction.~   "
126286|NCT01402570|"~     In this study, people who have symptoms of post polio will take oral glutathione supplements~     for three months. Their levels of fatigue, physical activity and sleep efficiency will be~     assessed.~   "
126287|NCT01402557|"~     Obesity can cause many health problems, including high blood pressure, diabetes, heart~     disease, and stroke. Although some people may lose weight through diet and exercise, many~     regain weight over time. There is a need to study new ways of helping people maintain their~     weight. The purpose of this research is to study the effect of a weight maintenance program~     provided through home television sets connected to the Internet.~   "
126259|NCT01402921|"~     Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous~     insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based~     on studies carried prior to CEAP classification (2004). Item C3 of this classification~     relates to patients suffering from chronic venous disease and permanent oedema. Literature~     mentions only one study in which volume reduction in venous-induced oedema was primary~     endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a~     Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible~     quantitative measure considered nowadays as being gold standard when objectifying oedema~     variation. It is therefore particularly relevant in a C3-patient trial (CEAP~     classification).~      The main objective of the current study is to evaluate the clinical effect of Progressiv'~     MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.~   "
126260|NCT01402908|"~     The purpose of this study is to determine if PI-88 is effective and safe in patients who~     have had surgery to remove primary liver cancer.~   "
126261|NCT01402895|"~     The purpose of this study is to determine if a certain treatment for low back pain can~     change the way nerves in the leg send messages. Specifically, the investigators will examine~     whether a particular type of physical therapy treatment for individuals with low back pain~     (neurodynamic techniques) changes the speed that nerves send/receive signals to/from the~     leg, as compared to a different physical therapy treatment.~   "
126262|NCT01402882|"~     The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on~     mortality and disability in patients with traumatic brain injury. The effect of tranexamic~     acid on the risk of vascular occlusive events and seizures will also be assessed.~     Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants.~     This nested study (CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS]) will examine the~     effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans~     in approximately 1,000 patients randomised into the CRASH-3 trial.~   "
126263|NCT01402869|"~     To establish and compare maximum methemoglobin blood levels and times to maximum~     methemoglobin blood levels following the administration of the injectable local anesthetics~     prilocaine and lidocaine when used for dental treatment in pediatric patients under general~     anesthesia. Patients will be randomized into three equal study groups. Two of the study~     groups will receive local anesthetic and the third group will not. Methemoglobin blood~     levels will be non-invasively monitored and recorded throughout dental treatment for all~     groups using a Masimo Radical-7 Pulse Co-Oximeter device.~   "
126264|NCT01402856|"~     Teenage driving safety continues to be a major public health issue. Two factors have been~     found to contribute to a higher teenage driving accident rate than adults: lack of driving~     experience, and risky behaviors. Insufficient driving experience puts teenagers at a~     disadvantage in detecting and responding to hazards while driving. Factors contributing to~     distracted driving (a diversion in the driver's attention from the road) may include:~     talking or text messaging on a cell phone, applying makeup, having multiple passengers,~     listening to loud music, eating/drinking, smoking or reading while driving.~      This is a prospective study designed to evaluate the effect of an educational program on the~     risks associated with distracted driving for teenage drivers. The researchers will compare~     cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New~     Jersey, where cell phone laws exist, and will educate the beginner driver on the potential~     dangers associated with driving without a seat belt, substance use, and participating in~     distracting driving behaviors. Knowledge of state laws will also be assessed.~      Objectives~        1. Educate participants on the potential dangers of distracted driving.~        2. Evaluate the impact of the educational program on teenage distracted driving behaviors~          by obtaining and analyzing information from student surveys, state law quizzes, and~          anonymous observation, pre, post, and delayed post education.~        3. Quantify distracted driving behavior in teenage driver's attending local area high~          schools by obtaining and analyzing information from student surveys, state law quizzes,~          and anonymous observation, pre, post, and delayed post education.~        4. Qualify distracted driving behavior in teenage driver's attending local area high~          schools by obtaining and analyzing information from student surveys, anonymous~          observation, and anonymous voicemails, text messages, and/or emails pre, post, and~          delayed post education.~      Qualify distracted driving behavior in adults through anonymous observations near local area~     high schools.~      6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New~     Jersey.~      7. Compare seat belt usage, driving behaviors, and substance use in the study population to~     the state and national averages pre and post education.~      8. Compare averages of student's knowledge of state driving laws pre and post education.~   "
126265|NCT01402843|"~     Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a~     representative ARB-series anti-hypertensive drug, have been authorized for use also in South~     Korea. They have been tested in many countries and proved to be effective and safe. The~     concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs~     and antihypertensive drugs are simultaneously administered to such patients. The combined~     administration of statin-series drugs and CCB-series drugs have.~   "
126266|NCT01402830|"~     The purpose of this study is to evaluate the relationship between cancer pain and risk of~     depression among cancer patients.~   "
126267|NCT01402817|"~     This is a pilot study to determine if adults and children with neurofibromatosis type 1 who~     have plexiform tumors given Sutent® respond to this drug therapy.~   "
126268|NCT01402804|"~     Introduction:~      Different groups already showed in retrospective subgroup analyses, that there is an~     increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.~      Methods:~      Light-Transmission aggregometry~      Hypothesis:~      Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting~     effect of ASA.~   "
126269|NCT01402791|"~     The primary objective of this study is to evaluate the presence/absence and description of~     persistent sexual troubles following surgical treatment for endometriosis for women, and~     their partners.~   "
126270|NCT01402778|"~     Major interest in our investigation is to find out whether distinct fixation techniques~     influence catheter dislocation and/ or incidence of local inflammation. A systematic~     comparison of two different fixation techniques with regard to catheter location, analgetic~     potential and signs of local inflammation will be conducted. To ensure identical patients~     groups allocation will be strictly randomized. Furthermore, both patient groups will receive~     identical pain medication via the peridural catheter in situ. All catheter tips will be~     screened microbiologically after removal.~   "
126271|NCT01402765|"~     The primary objective of this study is to compare the distribution of pressure among~     pressure interfaces between two anti-bedsore mattresses.~   "
126272|NCT01402752|"~     The primary objective of this study is to evaluate the reproducibility of a method of~     measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a~     tracer.~   "
126288|NCT01402544|"~     To determine if patients treated early after diagnosis of wet age-related macular~     degeneration can return/maintain to their baseline pre-disease BCVA.~   "
126289|NCT01402531|"~     This is a research study to find out more about the use of Avastin (proper chemical name is~     bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary~     Hemorrhagic Telangiectasia (HHT).~   "
126279|NCT01402661|"~     The Corrona Data Collection Program study is designed to systematically collect and document~     use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs),~     biologic agents and any other treatments currently used in the management of Rheumatoid~     Arthritis (RA), Undifferentiated Arthritis (UA), Psoriatic Arthritis (PsA), and other~     rheumatic diseases. Data collected through the Corrona Data Collection Program will be~     maintained in a comprehensive database (the Corrona Database), which will be used for~     purposes related to clinical, outcomes, and market research. Participating physicians will~     have access to information about their own participating patients, and may use this~     information for purposes such as research and in providing patient care. It is anticipated~     that the study data may help improve the quality of information upon which clinical~     decisions are based.~   "
126280|NCT01402648|"~     The decreased Estrogen Receptor beta (ERβ) expression in the non adenomatous mucosa of~     ApcMin/+ mice favours intestinal neoproliferation. The dietary supplementation with a blend~     of ERβ agonists and lignin has been shown to recover ERβ to the healthy wild type levels,~     and a reduced polyp number and lower dysplasia was also observed in the adenomatous mucosa.~     In this randomised, double blind and placebo controlled study, we assessed if ERβ similarly~     guides the apoptotic control of cell proliferation in the non adenomatous colon mucosa of~     patients affected from sporadic adenopolyposis, prone to polyp recurrence. For 60 day in~     advance of the screening colonoscopy, patients were supplemented with a dietary blend of ERβ~     agonists and lignin (Eviendep, CM&D Pharma Limited, London, UK) on top their common diet~     (left unchanged during the study period), to study if the pro-proliferative behavior of the~     non adenomatous mucosa was effected. Sixty patients naïve from previous and concomitant~     hormonal or anti-inflammatory CRC chemoprevention were sequentially 1:1 randomised to active~     or placebo supplementation. ERα and ERβ (mRNA, Western Blotting, Elisa, immunostaining),~     TUNEL, caspase-3 and Ki-67 (immunostaining) were assessed in bioptic normal colon mucosa~     samples. Study power: 80%, type 1 error: .05 (two-tails). Statistics: Non parametric~     Wilcoxon test for efficacy. MANOVA for proliferative and apoptotic biomarkers relationships~     to the common diet and to the 60 day supplementation.~   "
126281|NCT01402635|"~     The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten~     Emergency Department (ED) length of stay (LOS).~   "
126282|NCT01402622|"~     To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy~     (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in~     combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased~     intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes~     stretch and irritation of the peritoneum, is known to play an important role in~     postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases~     the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit~     (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications~     such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged~     hospital stay, and eventually increased medical cost.~   "
126283|NCT01402609|"~     The transition between acute care and community care represents one of the most vulnerable~     periods in health care delivery, particularly as the complexity of inpatient populations~     increases. Two recent North American studies found an incidence of post-discharge adverse~     events between 19-23%, with adverse drug events accounting for 66-72% of these. The~     vulnerability of this period has been attributed mainly to a failure of care providers to~     adequately reconcile discrepancies between home medications and discharge medications, as~     well as a failure to transfer this and other important information about the hospitalization~     and discharge to community care providers. While discharge communication with the primary~     care physician has traditionally occurred via a handwritten or dictated summary, major~     deficits exist with respect to timeliness of information transfer and adequacy of content in~     discharge summaries.~      Computer-enabled discharge communications can potentially avert such problems. This is~     particularly true for web-based solutions that do not require end users to acquire~     additional software/training to use them. The purpose of this research is to definitively~     assess the efficacy of a web-based seamless discharge communication tool that the Medical~     Ward of the 21st Century (W21C - see www.w21c.org) team in Calgary has developed through~     iterative consultation with multiple clinical stakeholders as well as patients/families.~     This tool has great potential to be implemented on a provincial level as well as across~     Canada and internationally because it operates on a web interface that does not confine its~     applicability to a single type of hospital information system.~      The purpose of this research is to definitively assess the efficacy of the web-based~     discharge communication tool that our team has developed in partnership with Alberta Health~     Services. In doing so, our specific objective will be to answer the following research~     questions:~        1. Is the seamless discharge communication tool efficacious with respect to reducing~          hospital readmission and mortality (at 3 months), as well as reducing adverse events~          and adverse drug events?~        2. Does the seamless discharge communication tool transfer appropriate, complete, and~          accurate discharge information in a timely manner compared to traditional discharge~          communication?~        3. Is the seamless discharge communication tool efficacious with respect to improving~          physician and patient satisfaction?~   "
126284|NCT01402596|"~     Thousands of children receive sedation for diagnostic and therapeutic interventions~     annually, and this number is expected to increase. Children are at higher risk for~     sedation-related complications than adults. In different scenarios, multiple drugs are used~     to achieve sedation, each one with particular adverse events that must be monitored and~     reported.~      Children that need CT scans for traumatic brain injuries often need sedation, without~     needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low~     incidence of adverse events; however, despite its worldwide use, it's being abandoned due to~     bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam,~     on the other hand, produces high and fast concentrations on CSF with greater rates of~     success but probably with higher adverse events. There are no prospective studies with large~     series of patients using intranasal midazolam.~      The aim of this study is to determine if nasal midazolam is a safer approach and more~     effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT~     scans.~   "
126285|NCT01402583|"~     Menopause represents a critical period in a woman's life as the hormonal changes and the~     failing ovarian function not only determine relevant modifications in the reproductive~     function but also in many other conditions and organs that apparently are scarcely linked~     with hormones. The PI's centre has among its main goals the treatment of chronic liver~     disease; in the last years, a increasing interest in gender-related issues has grown.~      Goal of this study is to verify the impact of menopause on response to antiviral therapy for~     CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve~     this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the~     University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic,~     clinical and biochemical data as well data regarding the reproductive history, time, type,~     length of estrogen deprivation and of hormone-replacement therapy will be collected.~   "
129014|NCT01366768|"~     The study hypothesis is that gut hormones are released after oral but not intravenous amino~     acids which result in stimulation of insulin secretion.~   "
126295|NCT01402453|"~     Despite unequivocal proof that tight control of blood pressure with antihypertensive~     medication can prevent hypertensive complications—including strokes, myocardial infarcts,~     heart failure, end-stage renal disease, and death— blood pressure remains uncontrolled in~     the majority of individuals with hypertension. We propose a novel patient-centered~     intervention that combines monetary incentives and a social psychological intervention to~     help patients sustain blood pressure control once incentives are no longer offered by~     strengthening intrinsic motivation to control blood pressure among two vulnerable~     populations: African Americans, who suffer disproportionately from hypertension, and Mexican~     Americans, who have the lowest hypertension control rates of any demographic group in the~     United States. If the intervention is successful, it could be adapted as a set of tools to~     apply in clinical practice to improve outcomes of a range of chronic diseases, by maximizing~     the motivation of patients to optimize their treatment.~   "
126296|NCT01402440|"~     This study has two phases, a dose escalation phase and a dose expansion phase. For dose~     escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in~     patients with diffuse large b-cell lymphoma. The endpoint for this objective will be~     occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to~     characterize the safety and tolerability of the maximum tolerated dose or recommended phase~     2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this~     objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs),~     assessment of clinical laboratory values, and vital sign measurements.~   "
126297|NCT01402427|"~     Background Verapamil is traditionally applied prophylactically in transradial procedures to~     prevent radial artery spasm. However, verapamil may have side effects and is contraindicated~     in some clinical settings.~      Methods: During an investigator‐initiated, randomized, double‐blind trial, we evaluate the~     need for preventive verapamil administration. After vascular access is established, patients~     receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site~     conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks~     (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural~     and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary~     end points.~   "
126298|NCT01402414|"~     In this controlled crossover study we aim to compare the efficacy of narrow-band UVB~     (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.~   "
126299|NCT01402401|"~     This study will assess the safety and efficacy of AUY922, when administered, in combination~     with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received~     trastuzumab plus chemotherapy in the first line.~   "
126300|NCT01402388|"~     The study seeks to establish if weight loss achieved through a program of intensive~     lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients~     with newly diagnosed type 2 diabetes mellitus.~   "
126301|NCT01402375|"~     There will be 2 randomized, double-blinded clinical trials to help determine which of~     commonly prescribed oral opioid combination is most effective in managing acute extremity~     pain after discharge from the adult emergency department. The first trial compares~     hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg while the second~     trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg.~   "
126302|NCT01402362|"~     High risk population: Screening for impaired glucose tolerance.~   "
126303|NCT01402349|"~     Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the~     paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence~     with significant impact on quality of life and substantial health care costs. In this study~     we evaluate the prevalence of CRS in Denmark and there is a need for consensus about~     diagnosing this disease. Different questionnaires and different tests used for examination~     are evaluated together with the patients compliance and days lost through illness.~      Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on~     CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires~     self reported CRS was evaluated. Respondents were invited for clinical examination including~     spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy,~     acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of~     life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was~     diagnosed according to the definition on CRS stated by EPOS (European Position Paper on~     Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and~     paranasal sinus and should be characterized by two or more symptoms one of which should be~     either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure,~     +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have~     been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year~     follow up where examination and questionnaires were repeated and treatment compliance and~     days lost through illness were evaluated.~   "
126304|NCT01402336|"~     GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been~     accomplished by several randomized controlled trials compared with conventional GnRH agonist~     long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating~     issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is~     to investigate the laboratory and clinical priority during ovarian stimulation for IVF in~     patients with PCOS treated with three different protocols.~   "
126305|NCT01402323|"~     Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic~     space closure after extraction of a tooth. They occur in about 35% of the cases. Increased~     risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination~     impairs aesthetics, orthodontic treatment and periodontal health. The aim of this~     prospective split-mouth designed observer blinded study is to evaluate possible differences~     between tooth movement in recent or in healed extraction sockets on incidence of gingival~     clefts. We hypothesize, that similar to the results originated from an animal study~     immediate movement in extraction sockets reduces incidence of gingival clefts during~     orthodontic space closure.~   "
126306|NCT01402310|"~     The purpose of this study is to compare Bishop score, sonographic cervical length and~     multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to~     spontaneous labor and mode of delivery.~   "
126308|NCT01402284|"~     Background:~      - Carfilzomib is an experimental anti-cancer drug that has not yet been approved for~     treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the~     immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is~     sometimes used to treat (alone or with other drugs) certain types of cancer, especially~     multiple myeloma. This combination of drugs has not been tested in people with multiple~     myeloma. Researchers want to see whether it is safe and effective for this group.~      Objectives:~      - To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in~     treating multiple myeloma.~      Eligibility:~      - People at least 18 years of age who have multiple myeloma that has not been treated.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood and urine tests, a bone marrow sample, and molecular imaging studies.~        -  Participants will have eight 28-day cycles of treatment. The combined study drugs will~          be given as tablets and injections. Those in the study will be monitored with frequent~          blood tests, bone marrow samples, and molecular imaging studies. In addition to current~          standard measures to determine clinical responses, molecular tests will be conducted to~          define evidence of minimal residual disease.~        -  After the first four cycles of therapy, those who are eligible for a stem cell~          transplant will have stem cells collected and stored for use if the cancer returns.~        -  After stem cell collection, participants will have the second four treatment cycles.~           -, If the disease has improved or is stable at the end of eight cycles, those in the~          study may have another 12 cycles of low-dose (maintenance) lenalidomide alone.~        -  Participants will have regular follow-up visits after the end of the study~          chemotherapy.~   "
126309|NCT01402271|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of~     pazopanib hydrochloride when given together with paclitaxel and carboplatin in treating~     patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or~     peritoneal cancer.~   "
126310|NCT01402258|"~     The purpose of this study is to determine whether tailored internet-administrated CBT is a~     feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive~     symptoms in a clinical setting.~   "
126311|NCT01402245|"~     Pneumococcal polysaccharide vaccine does not confer protection against noninvasive~     pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving~     Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)~   "
126312|NCT01402232|"~     To raise optimal strategies for reduction of risk of contrast-induced nephropathy according~     to several combinations of different risk factors and clinical practice and determine and~     supply the guidance for clinical practice~   "
126313|NCT01402219|"~     The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)~     following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque~     320) in patients with chronic kidney disease undergoing coronary angiography.~   "
126314|NCT01402206|"~     Most people in Sweden with mild to moderate depression are treated in primary care, but~     follow-up is unstructured, and we know little about whether structured, follow-up would~     affect the prognosis for depression and working life. The purpose of this study is to~     determine the effectiveness of regular, structured, patient-centered visits on mild to~     moderate depression.~   "
126315|NCT01402193|"~     The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential~     Arimidex in postmenopausal women with breast cancer, as measured by the proportion of~     patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy~     relative to the pre-treatment baseline.~   "
126316|NCT01402180|"~     A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to~     chemoradiation for patients with esophageal squamous cell carcinoma after radical~     esophagectomy who suffer with locoregional lymph nodes recurrence.~   "
126317|NCT01402167|"~     The primary objective of this study is to compare the volume of injected ciment (polymethyl~     methacrylate) between a group of patients treated with vertebroplasty and a group of~     patients treated via kyphoplasty. Secondary evaluation will compare the restoration of~     vertebral height, volume and cyphotic angle between the two techniques, as well as~     extravation of ciment and functional and quality of life aspects related to these~     techniques.~   "
126318|NCT01402154|"~     The primary objective of this study is to evaluate the predictive value (in terms of~     remission) of a new technique for detecting circulating, functional, prostate cells among~     patients with localized adenocarcinoma of the prostate, and prior to any treatment.~   "
126319|NCT01402141|"~     The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction~     in a double-blind, randomized, placebo-controlled, human trial~   "
126320|NCT01402128|"~     Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to~     significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely~     studied.~   "
126321|NCT01402115|"~     Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They~     are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well~     as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can~     prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified~     β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing~     effects. However, no investigation has been conducted on the effect of polycan on bone~     health in perimenopausal women.~      Therefore, in this study, we investigated the effect of polycan on biochemical markers of~     bone metabolism in Korean perimenopausal women.~   "
126322|NCT01402102|"~     We performed a double-blind parallel study in a group of mildly hypercholesterolemic~     subjects who were given aged garlic powder over a period of 12 weeks. We measured serum~     lipids, including total cholesterol, low-density-lipoprotein (LDL) and~     high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood~     pressure.~   "
126323|NCT01402089|"~     It is well known that substantial interindividual variability of CYP3A4/1A2-phenotype~     activity is an important contributor to individual differences in the sensitivity to the~     frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the~     potential for CYP-phenotyping to predict individual pharmacology and derive dosing~     algorithms for more tailored treatment of these drugs.~   "
126324|NCT01402076|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of midazolam (including its breakdown product) in the blood when midazolam is given~     with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the~     blood when rosiglitazone is given with tasimelteon.~   "
126327|NCT01402037|"~     Increased glycemic variability has been proposed as an independent predictor of hypoglycemia~     in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of~     diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth~     observational study comparing state-of-the-art measures of functional beta cell mass and~     glycemic variability will specify the relationship between both variables over a broad range~     of residual function and will identify treatment goals for functional beta cell mass to be~     reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in~     patients and dysglycemia in risk groups. The available expertise and infrastructure (see~     background and (inter)national context) place the promoters of the present project in a~     unique position to carry out the planned experiments and support their feasibility.~   "
126328|NCT01402024|"~     Chemotherapy induced nausea and vomiting (CINV) is one of the few mostly observed~     distressing toxicity of cancer treatment. It can occur up to 90% in case of highly~     emetogenic chemotherapy use. CINV causes disturbance in daily living of cancer patient and~     reduces compliance with treatment Even with the standard anti-emetic measures up to 50%~     patient can suffer from this complication. Whereas there is standard anti-emetic guideline~     exists in case of adult patients, there no such guidelines made in pediatric population. The~     new drug Aprepitant has been recommended for use in adults with high efficacy, there no such~     concrete data available in children regarding its use. There are few retrospective reports~     and limited data available regarding use of Aprepitant in children with satisfactory~     efficacy in reducing CINV. As there no randomized large data to suggests its efficacy and~     its routine use in children, we have planned this study.~   "
126329|NCT01402011|"~     HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments~     and tendons of the shoulder is an effective treatment that decreases pain, increases~     functional capacity and promotes healing better and in less time than standard treatment~     with physiotherapy.~      OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited~     and assigned randomly into one of three groups of 25 to receive one of these three different~     treatments:~      Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments~     Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group~     C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will~     receive physiotherapy every other week for three months. To avoid placebo effects, patients,~     the radiologist and physiotherapist will not know to which treatment group the patients~     belong; the physician administering the injections will not be involved in assessing~     disability before or after treatment. (Note: The physician will know which patients belong~     to group C because it will be obvious: they are delivering a subcutaneous - versus a joint -~     injection).~      There will be three sets of injections - one set per month for 3 months. The patients'~     condition will be tracked for nine months after the first treatment, to monitor changes in 3~     outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as~     assessed by ultrasound).~   "
126330|NCT01401998|"~     In 2005, The University of Alabama at Birmingham established a NIDDK-funded,~     interdisciplinary center of excellence in PKD-related research, with specific emphasis on~     recessive PKD. In the previous Core Center award period, we developed a Core Resource to~     capture clinical and mutational data for ARPKD patients (Core A: ARPKD Clinical and Genetic~     Resource, NCT00575705). However, studies in the last several years have demonstrated that~     ARPKD and other single gene disorders characterized by renal cystic disease and extra-renal~     phenotypes share numerous pathogenic features. In the current competitively- renewed Center,~     we have expanded this Core resource to include other hepato/renal fibrocystic diseases.~      Goals for the Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource are:~        1. - Clinical Database:~           • Expand our comprehensive Clinical Database to include information from all patients~          who meet the inclusion criteria for hepato/renal fibrocystic diseases.~        2. - Mutational Database:~             -  Test children with ARPKD and other hepato/renal fibrocystic disease to identify~               genetic mutations, establish a DNA bank for patients with hepato/renal fibrocystic~               diseases and develop a Mutational Database. This Database will be capable of~               linking clinical and mutational information via a unique identifier in a~               searchable format to facilitate genetic research (e.g. genotype-phenotype~               correlations, new disease gene studies, and modifier gene studies), translational~               studies, and clinical trials.~                3- Tissue Resource:~             -  Much of the research that is performed on diseases of the kidney, including~               recessive genetic diseases, requires human tissue from both affected as well as~               non-affected (controls) individuals. In this Core Resource, we are establishing an~               independent tissue resource which would supply investigators throughout North~               America with samples of hepato/renal fibrocystic disease affected tissues for~               studies of these disorders.~                4- Educational Resource:~             -  Expand our multi-media, web-based resource to provide a reliable up-to-date, and~               comprehensive informational resource for ARPKD and Hepato/Renal Diseases families,~               their physicians, and genetic counselors.~      All the information regarding participation in Core A: The Hepato/Renal Fibrocystic~     Diseases Translational Resource is available at: http://www.arpkdstudies.uab.edu/.~   "
126331|NCT01401985|"~     A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects~     with Opioid-Induced Constipation~   "
126332|NCT01401972|"~     In this observational study the investigators will undertake imaging studies on men with~     prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to~     determine the extent of disease inside and outside of the prostate gland in patients with~     prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained~     before radical prostatectomy could be used to correlate with pathological findings from the~     prostate specimen after surgery.~   "
126333|NCT01401959|"~     The investigators propose to evaluate eribulin as adjuvant therapy in patients who do not~     achieve pCR following standard neoadjuvant chemotherapy. Three cohorts of patients will be~     evaluated separately: triple-negative, hormone-receptor-positive/HER2-negative, and~     HER2-positive.~   "
126334|NCT01401946|"~     The study was done to elucidate relationships between midlife women's self-reported hot~     flashes, neuropsychological symptoms, cognitive performance or sleep.~   "
126335|NCT01401933|"~     This is a phase 1, open-label study designed to determine the interaction of rifampin with~     linifanib.~   "
126336|NCT01401920|"~     The trendelenburg position is usually applied to increase the cross-sectional area of the~     IJV. However, trendelenburg position requires a tilt table to place the head in the down~     position. Trendelenburg position could also increase intracranial pressure. Passive leg~     elevation redistributes more blood from the lower extremity into the central veins and is~     proved to increase the cross-sectional area of IJV in adults. However, the effect of leg~     elevation on the cross-sectional area of IJV in small infants and children has not been~     evaluated.~      The investigators evaluated the effect of passive leg elevation on the cross-sectional area~     of IJV in subjects undergoing open heart surgery for congenital anomaly.~   "
126411|NCT01401101|"~     The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress~     Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment~     processes and outcomes in patients seeking primary care from FQHCs and evaluate its~     effectiveness on improving the processes and outcomes of care for PTSD.~   "
126338|NCT01401894|"~     The purpose of this research study is to assess what the participant understands about their~     illness, prognosis, the goals of the cancer treatment and their communication with their~     oncology providers. This study will help us to figure out how the investigators can improve~     how other patients understand their illness and goals of treatment and help us improve~     communication with their doctors. This research is being done because there is not a lot of~     information on how much patients understand about their illness and prognosis.~   "
126339|NCT01401881|"~     This study will assess relationship between ischemic time and the extent of myocardial~     infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation~     myocardial infarction) and primary percutaneous coronary intervention.~   "
126340|NCT01401868|"~     The purpose of this study is to determine the tolerability of ME-143, find the maximum~     tolerated dose, and the safety profile in patients with refractory solid tumors.~   "
126341|NCT01401855|"~     This study will investigate the usefulness of an optical probe in the differentiation of~     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step~     in the research that this team has conducted through our prior Institutional Review Board~     (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical~     probe readings on thyroid specimens ex vivo could successfully discriminate benign from~     malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB~     approved and a clinical trial conducted in vivo at Boston University/Boston Medical Center~     by Dr. Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project~     to the clinical setting of thyroid disease. The optical real-time readings will be compared~     to the histological analysis from the same area. Subjects already undergoing thyroid biopsy~     for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with~     nodules will be eligible to participate. During the already scheduled thyroid procedure~     using a fine needle aspiration biopsy needle, optical readings will be taken from the~     thyroid gland and these same areas will then be analyzed in the usual standard fashion. The~     reading will then be correlated with the histological results. In addition, if lymph nodes~     are biopsied as part of the evaluation they will also be tested prior to histological~     standard processing. All specimens and data will be de-identified once data collection and~     analysis is complete. Our goal is to use optical real-time readings to improve the~     differential diagnosis of benign from malignant thyroid nodules and avoid surgery for the~     purpose of diagnosis alone.~   "
126342|NCT01401842|"~     The investigators will conduct a controlled clinical trial with U.S. Army soldiers training~     to become combat medics. The purpose of this study is to determine if a 11-week, high~     intensity exercise program targeting the low back muscles using specialized equipment will~     result in a 25% increase in low back muscular strength and endurance compared with a lower~     intensity general core stability exercise.~   "
126343|NCT01401829|"~     To determine if weekly exercise compared to stretching has an effect on fatigue, depression,~     and anxiety in endometrial cancer survivors.~   "
126344|NCT01401816|"~     Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are~     unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the~     birth of a child; the remaining proportion end in either abortion (30%) or miscarriage~     (20%). It has been estimated that if Emergency Contraception (Plan B) was used after every~     contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of~     abortions annually.~      Previous studies have showed the effectiveness of emergency contraception decreases with~     time after intercourse; the sooner it is taken—even if it means a matter of hours—the more~     effective it is in preventing pregnancy. Based on previous studies, it is clear that relying~     on obtaining emergency contraception on the same day or even the day after unprotected~     intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the~     adolescent mystery caller did not have the medication available the day of the call and~     almost all of the pharmacies not stocking the medication would take greater than 24 hours to~     obtain it through their ordering system.~      Thus, the concept of advanced provision of emergency contraception has been proposed to~     assure that the medication can be taken as soon as possible. Although this practice is known~     to be safe and has not shown any association with increased sexual risk or behaviors, it is~     unclear how often/if adolescents will fill a prescription for a medication that is not~     needed at the time of a medical encounter.~      The investigators propose a randomized pilot study (n=60) of a text-messaging intervention~     that aims to increase the rate at which prescriptions for emergency contraception are~     filled. Based on practice norms in the BMC Adolescent Center, sexually active female~     adolescents (ages 13-21) in both the control and intervention groups will be provided a~     prescription for emergency contraception. The intervention group, however, will receive~     follow-up text message on their phone reminding them to fill the prescription.~      Boston Medical Center Health Plan will provide prescription fill data regarding the~     prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all~     study participants will be contacted for a follow-up survey.~   "
126345|NCT01401803|"~     The purpose of this study is to provide data to assess Dysport™ injections as a treatment~     therapy for brow ptosis. This study will assess the outcome of brow lifting with use of~     Dysport.~   "
126346|NCT01401790|"~     In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient~     Monitoring Program was developed to allow for:~        -  Automatic download of blood glucose levels~        -  Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical~          team~        -  Changes in treatment plan by the diabetes professionals~        -  E mail exchanges between families and health care professionals~        -  Reinforcement of teaching program~      Use of this program does not replace the existing diabetes education program nor does it~     preclude contacts with the diabetes team. This service was devised to complement the care~     already in place for families of children and adolescents with diabetes, hence the term~     ''telehomecare-enhanced'' approach.~      Hypotheses~        -  This approach would not incur more health problems for Web e Phone users when compared~          to patients treated by the ''conventional'' approach (telephone and FAX).~        -  Use of the Web e Phone would save time for members of the diabetes health providers and~          consequently cut costs.~        -  This means of communication would be acceptable and user friendly for both families and~          health care professionals.~      OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in~     families of children and adolescents with newly diagnosed type 1 diabetes.~      RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1~     diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between~     February 2008 and August 2009, newly diagnosed patients and their family were randomly~     assigned to the standard education program or to the telehomecare-enhanced group. Outcomes~     of interest were patients' and parents' health (reported number for total and nocturnal~     hypoglycemias; quality of life using the Diabetes Quality of life for Youth questionnaire~     and a validated Life Habits survey); knowledge of diabetes (using pre and post intervention~     questionnaires); organizational impacts (number and time for contacts with the nurses or~     with the physician on call) and family satisfaction with the software application.~   "
126356|NCT01400672|"~     This is a pilot/feasibility study. The study design represents a modification of current~     standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field~     radiation), with the final two doses of radiation given at intervals during the vaccination~     phase of treatment.~      Patients between the ages of 3 years and 25 years diagnosed with Diffuse Intrinsic Pontine~     Glioma (DIPG) will be allowed to participate in the trial. Study enrollment will occur after~     the completion of conformal radiation therapy to a dose of 5580 cGy and the post radiation~     therapy (RT) magnetic resonance imaging (MRI) shows no disease progression.~      Three patients with glioblastoma multiforme, aged 16 years and older, will be entered first~     to confirm vaccine safety before enrolling DIPG patients.~   "
126347|NCT01401777|"~     The objective of this study is to assess and quantify any differences between assisted~     (using real-time visualization of tracked cryo-probes) and unassisted cryoablation~     procedures using pre-procedure CT scans or CT fluoroscopy with respect to:~      Primary Endpoint:~      • TRE Target Registration Error (distance between virtual needle position (tracking~     data) and the actual needle position (CT confirmation scan))~      Secondary Endpoints~        -  Accuracy of needle targeting - The vector of each needle insertion (The initial vector~          allows us to project the path to the pre-defined target. If the initial entry point is~          not ideal, the path to the target will need adjustment) Based on a two-sample t-test~          (significance level of 0.05, two-tailed), the study has 89% power to detect a~          difference of 2mm in accuracy between the two treatment groups (assuming a standard~          deviation of 1.9mm).~        -  Measure time difference between assisted and unassisted procedure~   "
126348|NCT01401764|"~     The purpose of the study is to compare local pain experienced after subcutaneous injection~     of three excipient buffers for delivering protein drugs.~   "
126349|NCT01401751|"~     The purpose of this study is to evaluate the performance of an insulin pump controlling~     algorithm while the subject is under close medical supervision in the Clinical Research~     Center (CRC) setting.~   "
126350|NCT01400750|"~     Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone~     chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new~     Pa infection.~   "
126351|NCT01400737|"~     Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in~     extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in~     preterm infants are non specific and insensitive for making an early diagnosis of~     significant ductal shunting. Functional echocardiography is emerging as a new valuable~     bedside tool for early diagnosis of hemodynamically significant ductus, even though there~     are no universally accepted criteria for grading the hemodynamic significance.~     Echocardiography has also been used for early targeted treatment of ductus arterioses,~     though the long term benefits of such strategy are debatable. The biomarkers like BNP and N-~     terminal pro-BNP are currently under research as diagnostic marker of PDA. The primary mode~     of treatment for PDA is pharmacological closure using cyclo-oxygenase inhibitors with~     closure rate of 70-80%. Oral ibuprofen is emerging as a better alternative especially in~     Indian scenario where parenteral preparations of indomethacin are unavailable and side~     effects are comparatively lesser. Though pharmacological closure of PDA is an established~     treatment modality, there is still lack of evidence for long term benefits of such therapy~     as well as there is some evidence for the possible adverse effects like increased ROP and~     BPD rates, especially if treated prophylactically.The aim of this study is to investigate~     the effect of oral ibuprofen prophylaxis administrated on the first 24 hours of life and the~     following two days on hemodynamically significant patent ductus arterioses and its long term~     effects such as ROP and BPD.~   "
126352|NCT01400724|"~     A prospective, randomized, controlled, open-label study will be carried out on 80~     post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP~     III). After a written informed consent, women will be randomly treated for 6 months with~     hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg~     plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty~     post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40~     treated with myo-inositol 2 g twice per day and forty treated with placebo for six months.~     The investigators hypothesize that the administration of myo-inositol would improve the~     insulin-receptor activity in these women, reducing insulin resistance.~   "
126353|NCT01400711|"~     Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of~     attenuating the stress response to surgery and enabling rapid recovery. There is strong~     evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in~     terms of significantly reduced postoperative complications and shorter length of hospital~     stay, compared to the patients of traditional treatment. However, few studies exist about~     the implication of ERAS programs in major upper abdominal surgery patients.~      The aim of this study was to compare morbidity, mortality and length of stay in patients~     undergoing major intrabdominal surgery, including upper and lower gastrointestinal,~     receiving either conventional postoperative care or an ERAS program.~   "
126354|NCT01400698|"~     Study of safety of Saizen® in children born with serious intra-uterine growth retardation~     (IUGR) treated to final height. An open, phase III study involving 17 centers in France.~      The study enrolled children who have completed 3 or 2 years of treatment and at least one~     year of post treatment observation in the Sponsor Studies GF 4001 (Safety and Efficacy of~     Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of~     Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR),~     respectively.~      Detailed description: Serious IUGR is a syndrome characterized by low birth length and~     weight for gestational age (less than 10 percentile). The secretion of growth hormone in~     response to provocative stimuli (e.g. arginine, insulin) is normal in these children. Apart~     from low birth weight, children born with IUGR may have minor or major malformations.~      A catch-up period with a supraphysiological growth velocity generally occurs during the~     first 6 to 24 months of life in 80 to 90 percent (%) of these children. This generally~     allows them to reach normal height. That means that conversely, approximately 10 to 20% of~     children do maintain a statural handicap. Puberty occurs at a normal age and the retardation~     in bone maturation present during the first years of life disappears very quickly. This~     leads to short adult stature in subjects who have not shown spontaneous catch-up during the~     first years of life. A safe and effective means of promoting growth without accelerating the~     timing or tempo of puberty would therefore be desirable.~   "
126355|NCT01400685|"~     Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can~     modify or regulate the functioning of the immune system. It is an FDA approved drug for~     people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic~     Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied~     for use in combination with chemotherapy in this and other lymphomas and leukemias.~      In this research study we are hoping to learn more about the effects of lenalidomide on CLL~     when given in combination with bendamustine and rituximab, which is a highly effective~     regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest~     dose of lenalidomide that can be given safely, without causing any serious or unmanageable~     side effects.~   "
126358|NCT01400646|"~     The purpose of this study is to explore the pharmacodynamic (what the drug does to the body)~     changes when transitioning from rivaroxaban 20 mg once daily to warfarin dosed to a~     therapeutic level as measured by the International Normalized Ratio (INR) range of 2.0 to~     3.0 in healthy volunteers. In addition, the pharmacokinetics (what the body does to the~     drug), safety and tolerability of rivaroxaban during the transition to warfarin will be~     investigated. The INR is obtained from a blood test, and is a measure for the clotting~     tendency of the blood used for safe and adequate dosing of warfarin.~   "
126359|NCT01400633|"~     The purpose of this study is to investigate the overall response rate (ORR) and safety when~     treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be~     administered as long as there is evidence of clinical benefit.~   "
126360|NCT01400620|"~     The purpose of this study is to determine whether an oral rinse composed of botanical~     extracts is effective in the prevention of severe inflammation of the lining of the oral~     cavity caused by chemotherapy and radiation therapy for head and neck cancer.~   "
126361|NCT01400607|"~     ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the~     safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4~     articular cartilage lesions of the knee compared to microfracture treatment.~   "
126362|NCT01400594|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.~   "
126363|NCT01401738|"~     This study is a retrospective review of chart. Clinical results including range of motion,~     muscle power and scores will be recorded. Arthroscopic surgery of rotator cuff, labrum and~     capsule well be re-evaluated for clinical application.~   "
126364|NCT01401725|"~     Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels~     of the legs or lungs. They can block normal blood flow, damage organs, and even cause death.~     The risk of VTE is increased in people who are sick or immobile. VTE is the most common~     preventable cause of death in hospitalized patients, and its VTE prevention should be a top~     patient safety priority. Though there is good evidence that injectable blood thinners and/or~     compression stockings can prevent VTE, over 30% of hospitalized medical patients in~     Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is~     in the process of introducing electronic order sets - computer programs that help doctors~     order medications and other healthcare interventions for their patients. The investigators~     would like to study if these electronic order sets can help improve the rate of appropriate~     VTE prevention in hospitalized medical patients. The investigators will examine the rate~     before and after the introduction of electronic order sets at the Juravinski Hospital and~     the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use~     an additional computer program, called a computerized decision support system (CDSS), that~     helps them decide on the best strategy to prevent VTE in individual patients. The rates of~     VTE prevention at each hospital will be compared to each other, and to the rates at St.~     Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.~   "
126365|NCT01401712|"~     Rib fractures are a common injury of trauma patients and can cause significant pain which,~     if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory~     failure. Hence, it is crucial to manage pain associated with rib fractures. Currently,~     epidurals are used to treat the pain, but placement can be risky as rib fractures are often~     associated with other injuries and complications.~      An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved~     device that automatically and continuously delivers medication to the region of the thoracic~     intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system~     effectively reduced pain and increased lung volumes after one hour, in patients with three~     or more rib fractures. However, that study sample was small and did not have a comparison~     group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia.~     We hypothesize that trauma patients with three or more rib fractures, who receive pain~     management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus~     have a shorter hospital length of stay (LOS) when compared with epidural analgesia.~   "
126366|NCT01401699|"~     The specific aim of this study is to determine the accuracy of Optical Coherence Tomography~     (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a~     clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using~     the developed OCT imaging probe will be determined and compared with those obtained through~     the traditional standard of care endoscopic biopsy .~   "
126367|NCT01401673|"~     The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic~     cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation~     is a hyper-excitability of the sensory nerves as they join the central nervous system, and~     is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].~   "
126368|NCT01401660|"~     The purpose of this research study is to measure with CERSR® (Computerized~     Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by~     the muscles in the lower back 1) when the subject has no low back pain 2) during the time~     low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4)~     to study the changes which take place in these muscles as the pain improves with physical~     therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan~     parameters for normal (pain-free) subjects are different from those of subjects with low~     back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy~     treatment which leads to relief of low back pain following no more than eight weeks of~     physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom~     improvement as measured using the Oswestry Disability Index.~   "
126369|NCT01401647|"~     The primary objective of the trial is to determine if survival to hospital discharge is~     improved with early therapeutic administration of a new Captisol-Enabled formulation of IV~     amiodarone (Nexterone-PM101) compared to placebo.~   "
126410|NCT01401114|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Wellnara for~     postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of~     using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3~     years since starting Wellnara administration.~   "
126370|NCT01401634|"~     Diabetes and high blood sugar are extremely common among patients presenting to US Emergency~     Departments. Intravenous fluids with or without insulin are often used to treat these~     patients. However, simple, low-cost interventions, such oral hydration have not been studied~     in this context. Oral rehydration may be better than no therapy at all, which is often what~     these patients receive in the first few hours when presenting to busy, overcrowded Emergency~     Department (ED) with long wait times, or in resource-poor environments such as developing~     countries. The investigators propose a study to see if oral hydration for adult patients~     presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500~     mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients~     will be given intravenous fluids per our department protocol, while the other half of the~     patients will be given 2 liters of water to drink over a 1-hour period. Both groups will~     have their blood sugar measured every 30 mins for 2 hours. The investigators will analyze~     the data to determine if there is a statistically significant difference in blood sugar~     between the two groups within 2 hours.~   "
126371|NCT01401621|"~     The goal of this project is to determine whether prompting the recipient of a health~     reminder mailing to scratch off targeted area.~   "
126372|NCT01401608|"~     This study will assess the outcomes of using magnetic navigation to treat ventricular~     tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons~     and are not related to structural heart disease.~   "
126373|NCT01401595|"~     The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro~     in the treatment of the Night Eating Syndrome.~   "
126374|NCT01401582|"~     Caring for people with dementia and treating them is a major challenge for the health care~     system in Germany. Among the challenges for population-based health care research are (a)~     identification and early recognition, (b) multimorbidity and (c) the integration of persons~     with dementia into the health care system. One setting which is identified to meet the~     challenges is the primary care setting and there especially the general physician. There~     have been a few interventional studies, which have been restricted to selective samples and~     have been conducted in inpatient settings.~      The purpose of this study is to test the efficacy of implementing a subsidiary support~     system for persons with dementia living at home. This subsidiary support system is initiated~     by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main~     goals are to improve quality of life and health care of the person with dementia and reduce~     caregiver´s burden.~      The study is a general physician based cluster-randomised controlled intervention trial. A~     population based sample of general physicians will be asked to participate in a systematic~     screening trial to identify people with dementia in primary care in Mecklenburg Western~     Pommerania, a federal state in Germany. Upon identification the people will be asked to~     participate in the DelpHi-MV study and after having given written informed consent will then~     be assigned to an intervention and a control group. Identification of people with dementia~     will be achieved by a short screening questionnaire in the physician's office. An extended~     in-depth data assessment will be conducted after inclusion into the study and then annually~     to measure the course of the people's health. Data assessment will be done at the people's~     homes.~      People assigned to the intervention group will receive an intervention provided by Dementia~     Care Manager. The Dementia Care Manager is a specialised nurse that is going into the~     person's home to manage the care of dementia as well as caring for the person's relative/ or~     carer.~   "
126375|NCT01401569|"~     This study investigated the efficacy of an exercise and counseling intervention for~     depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D~     score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8~     weeks of intervention: individually delivered exercise and counseling (for smoking cessation~     and physical activity) or control: health education contact control condition.~   "
126376|NCT01401556|"~     The objective of the proposed research is to improve quality of care for older outpatients~     who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist~     or other upper extremity fracture. Although most of these patients warrant evidence-based~     and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate~     treatment rates less than 10-20% in the year post-fracture. Several trials, including the~     investigators own prior studies, have tried to address this osteoporosis care-gap and have~     reported that various multifaceted interventions (combinations of patient and physician~     education, guidelines, and physician reminders) can modestly improve treatment rates~     compared with usual care, although 60-70% of the patients exposed to these interventions~     still remain untreated. The investigators believe that a case-manager (who identifies and~     independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers~     guideline-based treatment to those with low BMD) represents a potential solution that holds~     great promise.~      The investigators hypothesize that an osteoporosis case-manager will effectively and~     efficiently increase rates of osteoporosis treatment in older outpatients with upper~     extremity fractures when compared with a documented effective and cost-saving multifaceted~     intervention. To test this hypothesis the investigators propose a pragmatic patient-level~     randomized controlled comparative effectiveness trial with blinded outcomes ascertainment~     that compares the case-manager strategy with the multifaceted intervention.~   "
126377|NCT01401543|"~     This study compares LY2452473 taken orally as a 5 mg capsule at the same time as a 5 mg~     tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5~     mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil~     circulating in the blood for each treatment. Side effects will be documented. This study is~     approximately 34 days not including screening.~   "
126378|NCT01401530|"~     The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through~     observation of dose limiting toxicity (DLT), which is in advance defined, in patients with~     peripheral or cutaneous T-cell lymphoma.~   "
126379|NCT01401517|"~     Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound~     healing and prevent tissue necrosis in animals. Since patients with PAD experience many of~     these problems, this study will seek to determine whether this drug, when given orally,~     could provide the same benefits to patients with PAD.~   "
126380|NCT01401504|"~     A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced~     malignancies (solid tumors).~   "
126396|NCT01401296|"~     200 persons with depression are recruited via internet depression forums devoted to~     depression and are randomly assigned either to the online program deprexis or to a wait-list~     control condition. All participants receive free-of-charge online access to deprexis either~     immediately or with an eight week delay.~      Prior to intervention and eight weeks later, both groups are assessed via an anonymous~     online survey which was implemented using the software package OPST®. The survey consists of~     different questionnaires. The Beck Depression Inventory (BDI) represents the primary~     outcome. It is assumed that the severity of depressive symptoms will improve to a~     significantly greater extent in the deprexis than in the wait-list control condition in the~     course of eight weeks.~   "
126381|NCT01401491|"~     Clozapine has been virtually the only psychopharmacological choice in patients with~     schizophrenia who either did not response to typical neuroleptics or experienced severe~     extrapyramidal side effects and consequently did not tolerate this medication. There are~     patients who do not respond to clozapine, and the need to treat these severely ill patients~     frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical~     basis. One strategy is the combination of various other somatic treatments with clozapine.~      Recently, the investigators conduct a preliminary open trial to evaluate the safety and~     efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic~     patients. The combined treatment is well tolerated, and clinical improvement is observed in~     our patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight~     gain and metabolic disturbance. However, the effects of fluvoxamine on the safety and~     therapeutic efficacy of clozapine need to be further clarified in double-blind study.~   "
126382|NCT01401478|"~     Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at~     thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5~     Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into~     the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will~     be assessed during the study.~   "
126383|NCT01401465|"~     This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with~     perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy~     of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel~     patient-administered assessment, developed and validated to measure patient satisfaction~     with and preference of intranasal corticosteroids (INCS) for the treatment of allergic~     rhinitis (AR), is utilized in this study.~   "
126384|NCT01401452|"~     The aim of this post-marketing observational study (PMOS) is the assessment of effectiveness~     of Adalimumab in moderate to severe Plaque Psoriasis patients with distinct co-morbidities~     and impact of Adalimumab on the quality of life in routine clinical praxis over the period~     of 9 month. Psoriasis is associated with several co-morbidities such as depression, obesity~     and metabolic syndrome. Until now it is unclear if these co-morbidities are due to the~     pathophysiology of psoriasis or psoriasis-associated behaviors (e.g. smoking and alcohol~     abuse). Disease severity is correlated with smoking and alcohol abuse. The severity of~     psoriasis shall be established before and under treatment of Adalimumab by calculation of~     the Psoriasis Area Severity Index (PASI) and the analysis of Dermatology Life Quality Index~     (DLQI) in Patients with at last one co-morbid disease and/or symptom. Also the prevalence of~     co-morbidities in consideration of gender and other parameters of Life Quality (SF-36) and~     Life-Quality for specific co-morbidities should be evaluated.~   "
126385|NCT01401439|"~     The purpose of this study is to find out whether measurement of body composition has a~     prognostic value on clinical and overall outcome in pediatric patients with cystic fibrosis.~   "
126386|NCT01401426|"~     Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been~     approved as a treatment of morbid obesity. The standard laparoscopic operation requires five~     small incisions for the introduction of instruments and the band into the patient's abdomen.~     The investigators have developed a technique for performing this operation through a single~     incision at the belly button. This study compares this method to the conventional 5-incision~     approach.~   "
126387|NCT01401413|"~     The purpose of this study is to determine whether the use of the drug ramelteon decreases~     the symptoms of REM Sleep Behavior Disorder.~   "
126388|NCT01401400|"~     Background and rationale Chronic hepatitis B is the most common cause of liver cirrhosis and~     hepatocellular carcinoma worldwide.(1) Antiviral therapy with oral nucleoside analogs and~     interferon can reduce viral load and hepatic necroinflammation, and may reduce the risk of~     hepatocellular carcinoma and cirrhotic complications. (2-4) Peginterferon has both direct~     antiviral and immunomodulatory effects. The advantages of this drug include a finite course~     of treatment and the lack of drug resistance. However, it requires subcutaneous injections~     and carries some side effects. Besides, only 30% to 40% of treated patients have sustained~     response to treatment.(5-8) To reduce the costs and side effects of treatment, it is~     important to predict if a patient will respond to peginterferon. Genetic host studies on~     peginterferon response will provide a lot of knowledge on the interaction between the host~     and the virus to induce immune control, also outside the setting of immune modifying~     therapy. Recently, genome wide association studies (GWAS) identified genetic polymorphisms~     of the IL28B gene that were shown to be associated with treatment response to interferon and~     ribavirin in patients with chronic hepatitis C.(9-12) The same polymorphisms are also~     associated with natural clearance of hepatitis C virus. Whether the same phenomenon applies~     to patients with chronic hepatitis B is unclear. Furthermore, response to conventional~     interferon has shown to decrease the risk of hepatocellular carcinoma and to prolong~     survival.(13) Virological and serological response to PEG-IFN is durable in a substantial~     proportion of patients through 3 years of follow-up (14), but whether treatment benefits are~     sustained after that period and amount to clinically meaningful results is unknown. To date,~     a GWAS to predict the response to peginterferon in chronic hepatitis B patients has not been~     performed. Polymorphisms in genes such as IL28B can be identified through a GWAS and can be~     used to assess the chance of response to treatment and select patients who have a high~     probability of response to peginterferon.~      We aim to perform a GWAS in chronic hepatitis B patients previously treated with~     peginterferon to identify polymorphisms in genes that are associated with response to this~     treatment regimen.~   "
126389|NCT01401387|"~     This study will evaluate the effect of immediate pancreatic enzyme suppletion on the~     physical and mental health status and survival of patients who are diagnosed with pancreatic~     cancer and are highly likely to develop exocrine pancreatic insufficiency during their~     disease process.~   "
126390|NCT01401374|"~     The study is an on-line survey posted on survey monkey that addresses some demographic and~     environmental issues that could potentially relate to vitiligo vulgaris onset or disease~     exacerbation.~   "
126391|NCT01401361|"~     To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction~     with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter~        -  Does not result into unacceptable risk of intra-procedural composite serious adverse~          events and,~        -  Does not affect efficacy of the ablation procedure The study will also evaluate the~   "
126392|NCT01401348|"~     A research study to evaluate the effect of aging and HIV on neurocognitive dysfunction~     (declining ability to process information), physical frailty and heart disease. HIV-infected~     participants whose virus is controlled on antiretroviral medications will be studied to~     determine the rates and risk factors of developing these conditions.~   "
126393|NCT01401335|"~     The investigators propose a prospective single arm pilot cohort study of 100 youth (ages~     15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be~     enrolled on a voluntary basis from those who come to the day care center located in Nyanza,~     a district of the Southern province, in Rwanda.~   "
126394|NCT01401322|"~     Time-to-Progression (TTP)~   "
126398|NCT01401270|"~     The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6~     conditions: (a) a control group, (b) a contingency management condition that arranges a 100%~     probability of winning a prize with each draw and has 3 prize categories, (c) a contingency~     management condition that arranges a 31% probability of winning and has 3 prize categories,~     (d) a contingency management condition that arranges a 100% probability of winning and has 7~     prize categories, (e) a contingency management condition that arranges a 31% probability of~     winning and has 7 prize categories, or (f) usual prize contingency management with a 50%~     probability of winning from 3 prize categories. Magnitudes of reinforcement will be~     identical across conditions, but lower overall probability conditions arrange for greater~     chances of winning larger magnitude prizes. The investigators expect that the new~     contingency management conditions will reduce cocaine use relative to the control condition,~     that 31% probability conditions will decrease drug use relative to 100% conditions, and that~     7-prize category conditions will reduce drug use compared to 3-prize category conditions. In~     addition, the 31%/7-category condition is expected to be most efficacious. Results will be~     instrumental for further developing prize contingency management to improve outcomes of~     cocaine-dependent methadone patients.~   "
126399|NCT01401257|"~     The present trial is a randomized, placebo-controlled study evaluating 3 different doses of~     PXT3003 in patients with CMT1A disease.~   "
126400|NCT01401244|"~     This trial is conducted in United States of America (USA). The aim of this trial is to~     examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.~   "
126401|NCT01401231|"~     This pilot study will examine the feasibility, acceptability, and effectiveness of a brief~     behavioral activation psychotherapy for women with perinatal depression.~   "
126402|NCT01401218|"~     Postoperative acute kidney injury (AKI) is still one of the serious complications of~     thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly~     increases the morbidity and mortality of patients undergoing thoracic aortic surgery.~     Previous studies for AKI after DHCA reported confounding results due to different criteria~     of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI~     after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI~     reported from acute kidney injury network. The investigators also tried to develop a risk~     model with scoring system of AKI and evaluate the performance of the risk model.~   "
126403|NCT01401205|"~     The investigators applied upper airway ultrasonographic examination focusing the measurement~     of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate~     the change of upper airway anatomy before and after the surgery. The investigators also~     tried to find any findings of ultrasonographic examination that could reliably predict the~     dyspnea or airway compression after extubation. The investigators tried to compare the~     ultrasonographic findings with those of chest radiograph to validate the measurements of the~     ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to~     predict the upper airway obstruction in shoulder arthroscopic surgery.~   "
126404|NCT01401192|"~     This study trys to evaluate the predictive role of thymidylate synthase expression for~     pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).~   "
126405|NCT01401179|"~     The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis~     and neonatal morbidity and mortality, and to review the evidence and provide recommendations~     on the use of antibiotics in PPROM.~   "
126406|NCT01401166|"~     This randomized, open-label, crossover study evaluated participants' preference and~     healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus~     intravenous (iv) administration in participants with HER2-positive early breast cancer.~   "
126407|NCT01401153|"~     Major aim of this study is to add scientifically proven insights into cognitive effects of~     meals to the existing recommendations for school meals in Germany. As a first step the~     short-term effects of skipping lunch on children's cognitive functioning in the afternoon~     will be examined in a cross-over trial. The study is conducted in a large comprehensive~     school in Gelsenkirchen (Germany) including about 150 children.~   "
126408|NCT01401140|"~     An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary~     revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac~     surgical interventions, it is performed with the heart stopped; this leads to more or less~     severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a~     duration that varies depending on the number of bypasses required, and on the local~     difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes.~     Heart protection during coronary revascularization surgery remains a crucial factor in~     limiting the heart's aerobic function during aortic clamping, and in minimizing the~     resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the~     post-operatory issue.~      High-performance heart protection solutions such as Custodiol have been used by heart~     surgeons for a few years. They are used as an alternative choice to other cardioplegic~     solutions, the efficacy of which has already been proven (St Thomas). These two myocardial~     protection solutions have never been evaluated in an in vivo, randomized, comparative trial.~   "
126409|NCT01401127|"~     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but~     problems with metabolism and blood glucose control can make this difficult. Some people with~     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous~     insulin infusion (CSII) therapy, in which a background or basal level of insulin is~     constantly infused under the skin by a special pump, with bolus doses of insulin given to~     accompany food. Clinical experience suggests that this may be particularly useful for~     managing diabetes for exercise, but there is limited experimental evidence to support this.~     The aim of this research , which is divided into three parts, is to investigate the~     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person~     with type 1 diabetes treated with CSII, can be made to approximate more closely to the~     physiological response of a healthy individual by a prior reduction of their basal insulin~     infusion rate. This first part of the research is designed to compare metabolic response to~     exercise between people without diabetes and people with T1DM running there insulin pump at~     the usual basal rate.~   "
126412|NCT01401088|"~     The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial~     Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory~     glaucoma.~   "
126415|NCT01401049|"~     The purpose of this study is to compare the incidence and intensity of possible pain on~     injection as well as patient satisfaction caused by propofol (a lipid based medication);~     Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a~     local anesthetic commonly used with propofol injection).~   "
126416|NCT01401036|"~     Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated~     stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting~     Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction~     (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI~     between patients receiving Nobori versus uncoated stents.~   "
126417|NCT01401023|"~     This is a prospective, non-comparative, interventional, observational pilot study of the~     safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard~     oral therapy in patients with known mild to severe confirmed Clostridium difficile~     associated diarrhea (CDAD).~   "
126418|NCT01401010|"~     Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic~     patients.~      Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and~     Reported as Probability of Target Attainment (40% Time (fT)> minimum inhibitory~     concentration (MIC))~   "
126419|NCT01400997|"~     This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of~     Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone~     treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.~   "
126420|NCT01400984|"~     This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
126421|NCT01400971|"~     The purpose of this study is to identify specific patient, physician, and health system~     related factors associated with the progression to a more intensive regimen from initial~     insulin therapy for patients with type 2 diabetes.~   "
126422|NCT01400958|"~     The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people~     receiving external beam radiation therapy for the treatment of malignant gliomas. It is also~     being done to determine if Nuvigil® improves cognitive function (perception, thinking,~     reasoning, and remembering) and overall quality of life in people receiving external beam~     radiation therapy for the treatment of malignant gliomas. Another purpose of this study is~     to see if people who receive Nuvigil® have more or less side effects than people who receive~     placebo. Placebo is a substance that looks like an active drug but has no active ingredient.~   "
126423|NCT01400945|"~     The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD)~     patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.~   "
126424|NCT01400932|"~     This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study~     in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl~     peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate~     the safety of GI148512 when applied topically once daily for 12 weeks.~   "
126425|NCT01400919|"~     The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming~     the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™~     Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common~     and/or external iliac arteries.~   "
126426|NCT01400906|"~     People with asthma suffer from breathlessness because the small tubes (bronchioles) that~     carry air in and out of the lungs become inflamed and narrow. Steroids reduce the~     inflammation, and are commonly used to control asthma, but they do not work well in some~     asthmatics, particularly those who smoke.~      This study is done to find out more about why smokers with asthma do not benefit from~     steroid treatment. In this study, the effect of Flixotide (fluticasone propionate), a~     steroid widely used to treat asthma, is tested in smokers and non-smokers with mild asthma.~      16 smokers and 16 non-smokers, aged 18−55 years will be enrolled in this study.~      Subjects will take each of the following treatments:~        -  100 micrograms Flixotide twice daily for 7 days;~        -  500 micrograms Flixotide twice daily for 7 days; and~        -  placebo (dummy medicine) twice daily for 7 days.~      Study design: subjects will have a screening visit (over 2 days), and will take part in 3~     treatment periods (which are separated by interval of at least 14 days); a follow-up visit~     is scheduled 7 days after the last intake of study treatment.~      The order in which order the subjects will take the treatments is defined at random. Total~     study duration: about 11 weeks.~      To test the effects of Flixotide, the subject's responses to :~        -  an inhaled allergen test~        -  a PC20 methacholine test~        -  blood, urine and sputum PD markers will be analysed.~      This study will take place in 2 centres: 1 in the United Kingdom and 1 in Belgium. The units~     will recruit participants by advertising (newspaper, radio, and websites), word of mouth,~     from volunteer databases, and via the centres' websites.~   "
126427|NCT01400893|"~     The purpose of this protocol is to evaluate the safety of a selective cytopheretic device~     (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney~     injury (AKI).~   "
126428|NCT01400880|"~     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and~     maternal heart rate and contraction monitor that is unaffected by obesity and requires less~     nursing intervention than the tocodynamometer and Doppler ultrasound.~   "
126429|NCT01400867|"~     This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil~     in children with skin infections receiving antibiotic therapy in the hospital.~   "
126430|NCT01400854|"~     Aim of this non-interventional study is to investigate the tolerability of Effentora® in~     cancer pain patients with breakthrough pain under real-life conditions in clinical practice.~   "
126431|NCT01400841|"~     This investigation is a prospective, non-randomized, multi-center trial to evaluate the~     safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically~     repair a leaking aortic valve using a 3-D intra-annular mounting frame~   "
126432|NCT01400828|"~     The objective of the study was to determine the efficacy and tolerability of 20 mg of~     Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic~     Rhinitis.~   "
126433|NCT01400815|"~     A randomized, active controlled clinical trial in which a total of 216 healthy smokers will~     be enrolled and followed over approximately 19 weeks.~      The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid.~      Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be~     randomized in a 1:1 ratio to 1 of the 2 treatment arms:~        -  Group 1: X-22 Cigarettes (very low nicotine)~        -  Group 2: Active Control Cigarettes The randomization will be stratified by gender.~          Efficacy will be assessed by analysis of cigarette consumption using self-report~          diaries and measurement of exhaled CO and cotinine concentrations.~      Safety will be assessed by evaluation of adverse events, physical examinations, clinical~     laboratory tests, and measurement of heart rate, blood pressure, and body weight at each~     study visit.~   "
126434|NCT01400802|"~     The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro~     Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter~     (PK) and the pharmacodynamic parameter (PD).~   "
126435|NCT01400789|"~     The aim of this study is to assess the bioequivalence of two premixed formulations of~     insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the~     pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).~   "
126436|NCT01400776|"~     Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due~     to vulvovaginal atrophy.~   "
126437|NCT01400763|"~     Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are~     members of the carotenoid family. Epidemiological evidence indicates that a higher intake of~     lutein and zeaxanthin is associated with a lower risk to develop age-related macular~     degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the~     efficient absorption of dietary lutein and it is possible to increase the natural lutein~     concentration in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced~     using these lutein-enriched egg-yolks. However, this beverage has a limited shelf life of~     maximum three weeks. Drying this fresh beverage extents the shelf live, however, this should~     be without loosing its functional properties concerning lutein bioavailability. At WUR-FBR~     two types of drying procedures have been evaluated resulting in two different dried product~     formulations, which need to be tested. The question is, whether the lutein bioavailability~     is not affected by different drying procedures.~   "
126438|NCT01400581|"~     The purpose of this study is to evaluate the effectiveness of a collaborative care~     intervention for evidence based management of alcohol use disorders in primary care settings~     within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake~     Divisions). The study will test whether patients offered the collaborative care intervention~     have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below~     recommended limits without problems.~   "
126439|NCT01400568|"~     This pilot study is planned to assess the suitability of a low dose Lipopolysaccharide (LPS)~     inhalation as a challenge model. As LPS effects are based on a different mode of action,~     this challenge model will provide the possibility to test a wider spectrum of potential~     drugs in the future. Provided that the LPS response is reproducible, it is planned to test~     whether a single high dose of inhaled steroid can serve as a positive control in the LPS~     model. Another major aim of the study is to test a variety of novel tools for the~     non-invasive assessment of airway inflammation induced by LPS challenge.~   "
126440|NCT01400555|"~     The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate~     administered in combination with docetaxel plus prednisone in patients with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
126441|NCT01400542|"~     Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the~     latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher~     in patients with dementia such as Alzheimer patients.~      Several trials in elderly patients showed modified cognitive functions, particularly~     executive and attentional functions, in patients with respiratory sleep disorder. However~     the benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients~     is still controversial, as there are few studies documenting its effects on dementia~     patients' cognitive abilities, and clinicians appear reluctant to prescribe this type of~     treatment.~      The investigators must keep in mind that Alzheimer patients suffer significant sleep~     disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part~     of the day. In dementia patients, sleep disorder is a major cause of hospitalization and~     institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is~     estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on~     obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores~     on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any~     impact on cognitive abilities has yet to be demonstrated.~      In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias,~     and strokes are strongly correlated to OSA. In light of its consequences on morbidity and~     mortality, OSA should be considered a public health issue.~      In this context, the investigators wish to address the impact of CPAP treatment~     implementation on the cognitive parameters of patients diagnosed with OSA, particularly on~     their executive functions. This should provide evidence for mid-term assessment of the~     benefits of CPAP in caring for elderly patients with dementia.~      In light of the prevalence of obstructive sleep pathologies in elderly patients reported in~     various studies and of the potential impact of CPAP treatment on cognitive abilities, the~     investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer~     patients' cognitive abilities, particularly on their executive functions.~      Executive functions are a rather heterogenous group of high-level cognitive processes which~     enable individuals to adopt a flexible, context-appropriate behavior. They also include~     planning abilities, working memory, cognitive control, abstract thought, rule learning,~     selective attention, motor response selection, etc... Executive functions are mainly~     associated to the functioning of the brain's frontal lobes, although subcortical structures~     also play a role. When the executive functions are affected by disease, daily life is~     significantly impeded as the individual becomes unable to perform complex tasks or regulate~     his/her behavior. Many tests can help evaluate these functions in dementia patients. A~     number of ecological tests, such as the zoo map test from the Behavioural Assessment of~     the Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive~     functions.~      This project aims to improve the daily life of Alzheimer patients with sleep apnea by~     improving their executive cognitive functions through CPAP treatment.~      According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire~     department. [27] The study population will therefore be recruited in the La Charité center~     of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from~     cognitive disorders similar to Alzheimer's disease.~      OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will~     receive CPAP treatment for 4 months, which is the minimum duration required to implement and~     accept treatment, and to measure its impact on patients' neurocognitive abilities.~   "
126442|NCT01400529|"~     Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence,~     based on a validated method previously used to assess inflammatory rheumatism (rheumatoid~     arthritis and spondylarthropathy) prevalence in France.~   "
126443|NCT01400516|"~     Summary:~      The investigators propose a randomized controlled open label study of teriparatide in men or~     women with rheumatoid arthritis and joint erosions. Specifically, the investigators will~     examine whether teriparatide in combination with a biologic can retard the development of~     joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis~     Center, several Brigham and Women's Hospital Arthritis Center satellite practices, the~     University of Massachusetts Medical Center, and Massachusetts General Hospital.~      Hypothesis:~      The investigators hypothesize that the combination of teriparatide with biologic will be~     much more effective at retarding erosion progression then a biologic alone.~   "
126444|NCT01400503|"~     The purpose of this study is to evaluate the long-term safety of siltuximab in patients with~     multicentric Castleman's disease (MCD).~   "
126445|NCT01400490|"~     The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a~     DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind,~     randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of~     EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200~     mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a~     parallel arm design study of 120 healthy adults studied in both the fasting and~     post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring~     vital signs and a variety of lab tests including a complete metabolic profile and complete~     blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or~     fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of~     inflammation.~   "
126446|NCT01400477|"~     The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene~     anabaseine sustained release) will provide clinical improvement in cognition in patients~     with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain~     abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.~   "
126505|NCT01399710|"~     RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is~     less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection~     (CAD) has shown promising results in providing uniform accuracy and improving CT~     colonography sensitivity.~      PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and~     CAD-assisted reading in detecting patients with colorectal lesions.~   "
126447|NCT01400464|"~     The factors underlying the large interindividual variability in response to glucocorticoids~     in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of~     this variability is related to pharmacokinetic factors determined by genetic polymorphism:~     hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux~     leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The~     investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic~     cohort study to assess the link between prednisolone clearance and the relapse risk in giant~     cell arteritis.~   "
126448|NCT01400451|"~     Treatment of subjects who have metastatic melanoma that expresses an activated mutant form~     of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib,~     and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and~     feasible and will show preliminary evidence of anti-tumor efficacy and survival in~     comparison to historical results following treatment with either agent alone.~   "
126449|NCT01400438|"~     Many studies have been devoted to the quality of life of patients during adjuvant~     chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on~     the immediate environment (spouse, children) during this difficult time for women.~     Curiously, no study to date has been submitted or published about how women with a one-year~     treatment extra Herceptin ® live this period in terms of quality of life, in terms of~     psychological impact for themselves and their families.~      The investigators have no more data on how often they return to work during this treatment~     or on the psycho-social parameters which underpin them. It therefore seemed interesting to~     give a spotlight on this particular period in these women HER2 + by comparing a patient~     population of same age receiving the same adjuvant but with no Herceptin ®.~   "
126450|NCT01400425|"~     The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical~     thinking when physicians are determining the likely cause of a subject's cognitive~     impairment.~   "
126451|NCT01400412|"~     The main purpose of this study was to compare the effects on bones of the following two drug~     combinations:~        -  maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r)~        -  tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r)~      Additional study objectives were the following:~        -  To see how the drug combinations affect the brain and kidneys.~        -  To see how well the drug combinations lower the HIV viral load.~        -  To see how safe the drug combinations are, how well people are able to take the study~          drug combinations, and how well their immune systems respond to the study drugs.~   "
126452|NCT01400399|"~     This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic~     outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy~     (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an~     established method of treatment for early breast cancer. Because breast conservation is~     essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and~     tumor control are all important considerations during comprehensive treatment planning.~     Irradiation schemes have been demonstrated to be efficacious and with excellent short term~     cosmetic outcomes. However, their interaction with currently evolving surgical techniques~     needs to be examined in order to maintain optimal local control while preserving cosmetic~     outcome.~   "
126453|NCT01400386|"~     Coffee contributes to a large extent to our daily intake of phenolic compounds which have~     been associated with potential health benefits. A study by Richelle et al. (2001), using an~     LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity~     which varied depending on the coffee bean source and the degree of roasting. Little is known~     about the bioavailability of phenolic compounds from coffee at various roasting degrees.~     Therefore, further human studies are required in order to demonstrate the absorption, and~     bioavailability of metabolites that may also be efficient in vivo.~      The main objective of this clinical trial is to investigate the possible difference in the~     bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.~   "
126454|NCT01400373|"~     Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest~     patients has recently been published in the PRINCE-study in Circulation 2010.~      The main purpose of this study is to determine whether prehospital intra-nasal cooling~     initiated during resuscitation, in addition to systemic cooling at hospital, increases~     neurological intact survival measured as cerebral performance category score (CPC-score)at~     90 days in witnessed cardiac arrests outside hospital.~   "
126455|NCT01400360|"~     Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount~     of transient or even permanent neurological deficits and poor outcome of the patients.~     Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators~     represents a rescue therapy for severe CVS. Indication, duration and efficacy of this~     treatment, however, is still under debate. Aim of the study is to investigate if such a~     rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH.~     Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive~     intraarterial therapy to more than 50 %.~   "
126456|NCT01400347|"~     It is generally accepted that the effectiveness of an exercise can be controlled not only by~     the weight or resistance applied but also by doing an exercise that would better target the~     desired muscle. The purpose of this study is to obtain objective information regarding~     selected lower extremity muscle activity during specific exercise and the influence of~     fatigue and speed on muscular activation.~   "
126457|NCT01400334|"~     The hypothesis of PAREPET is that hibernating myocardium (viable myocardium with reduced~     resting flow) and/or viable but denervated myocardium can predict the risk of sudden death~     in subjects with ischemic cardiomyopathy.~   "
126458|NCT01400321|"~     The open, prospective, non-controlled observational study is designed to provide information~     on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM~     implant surface in combination with a special implant design. The study will provide~     information on implant survival and soft tissue and bone maintenance as clinical performance~     of the OsseoSpeedTM TX Profile Implant in the aesthetic zone or the posterior mandible with~     socket like atrophy.~   "
126701|NCT01397149|"~     The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL~     patients, that shortens the duration of the thrombocytopenia and achieves platelet count of~     ≥ 100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine~     Analogues.~   "
126459|NCT01400308|"~     Multicenter Clinical Trial, experimental, randomized and prospective study to determine the~     effectiveness of two protocols addressing the Corporal Decolonization in patients colonized~     by Methicillin Resistant Staphylococcus Aureus (MRSA).~      PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol~     Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the~     Consensus Document and GEIH-SEIMC SEMPSPH (see attached extract from the document, Annex~     7).~      Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and~     currently available in Spain for the same indications proposed in this trial.~   "
126460|NCT01400295|"~     To determine a relatively safe contrast media volume to creatinine clearance cut-off value~     to avoid contrast-induced nephropathy in patients following coronary angiography~   "
126461|NCT01400282|"~     The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and~     sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation~     (Conv SCS) on the patient reported global impression of change, pain intensity and health~     related quality of life.~   "
126462|NCT01400269|"~     The purpose of this study is to assess the efficacy of a parent training program in the~     treatment of social and communication deficits in children with autism. Specifically, this~     study will evaluate a developmentally based parent delivered intervention in the community~     developed by Pacific Autism Center for Education (PACE).~   "
126463|NCT01400256|"~     The investigators hope to show that valsartan can be used safely in the setting of acute~     stroke to lower elevated blood pressure. There are novel properties of this class of drug~     (an angiotensive-receptor blocker or ARB), and promising human and animal data, that would~     suggest this drug can be safely used to lower blood pressure in the setting of acute stroke~     without compromising brain blood flow (i.e. cerebral perfusion). If this is proved to be the~     case, this compound could potentially be used routinely in this setting, with the hope of~     improving outcome. This pilot study may pave the way for a larger randomized trial looking~     at outcome measures in stroke patients. Further, a positive result in the this pilot study~     will serve as proof of concept that ARBs maintain cerebral perfusion while decreasing blood~     pressure, an overall favorable property.~   "
126464|NCT01400243|"~     The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch~     versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals,~     using a randomized, double-blind, and placebo-controlled design. This proposal is in~     response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders.~     Consistent with the goals of this RFA, the overall goal of the proposed project is to assess~     the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect~     and craving motivated by negative affect) symptoms in MJ-dependent individuals.~   "
126465|NCT01400230|"~     Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to~     detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard~     invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides~     tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is~     helpful to assess precise anatomical information. Optimal functional criteria and their~     accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.~   "
126466|NCT01400217|"~     This study will compare the absolute and relative effectiveness of asthma management in~     patients on inhaled corticosteroid (ICS) maintenance therapy as either extra-fine-particle~     or larger-particle formulation beclomethasone dipropionate (BDP) via metered-dose inhalers~     (MDIs) using the propellant hydrofluoroalkane propellant (HFA-BDP), namely Qvar® MDI~     compared with Clenil® MDI.~   "
126467|NCT01400204|"~     The aim of the study is to compare hangover effects of MDMA users versus those who used~     other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day~     participants complete a questionnaire about the presence and severity of potential hangover~     symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On~     day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4~     weeks, after a drug-free week, the BSI is completed again to serve as a reference.~   "
126468|NCT01400191|"~     The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy~     Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the~     study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy~     volunteers with functional OCT1-transporters.~   "
126469|NCT01400178|"~     Objectives: To assess a group of post-lingually children after 10 years of implantation with~     regard to speech perception, speech intelligibility, and academic/occupational status.~      Study Design: A prospective transversal study. Setting: Pediatric referral center for~     cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and~     Med-El cochlear implants.~      Interventions: Speech perception and speech intelligibility tests and interview.~      Main Outcome Measures: The main outcome measures were score of Hint sentences recognition~     (silence and noise), speech intelligibility scores(write-down intelligibility and rating~     scale scores) and academic/ occupational status.~   "
126470|NCT01400165|"~     Generic describes a pharmaceutical product that does not have a brand name or trademark.~     Generic medications should be the equivalent of brand medications. Only their price should~     be different. The active ingredient of the generic medication has to be within a window of~     80 to 125% of the original in the blood. There are reports that this standard is not always~     followed after the medication has been on the market. Indeed, it was observed that some~     patients previously stable on original medications relapsed when switched to a generic.~     Several factors could account for this problem. Such problems have been reported for~     Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and~     the original brands will be examined for these three medications. The three original~     medications used in this study are the Visken, the Seroquel, and the Desyrel. The three~     generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all~     available on the Canadian market by prescription.~   "
126573|NCT01398826|"~     The purpose of this study is to assess the glycemic response to cycling road races (using~     continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic~     controls. The investigators will also assess the relationship between power/work during~     cycling (using a power meter) and the subject's glucose profile.~   "
126471|NCT01400152|"~     Prevention and treatment of hypothermia by active warming in prehospital trauma care is~     recommended but scientifical evidence of its effectiveness in a clinical setting is scarce.~     The objective of this study was to evaluate the effect of additional active warming during~     road or air ambulance transportation of trauma patients.~      Patients were assigned to either passive warming with blankets or passive warming with~     blankets with the addition of an active warming intervention using a large chemical heat pad~     applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort~     and vital signs were monitored.~      Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5 °C) to 36.0°C (95% CI;~     35.7-36.3 °C) (p<0.05) in patients assigned to passive warming only (n=22) and from 35.6°C~     (95% CI; 35.2-36.0 °C) to 36.4°C (95% CI; 36.1-36.7°C) (p<0.05) in patients assigned to~     additional active warming (n=26) with no significant differences between the groups. Cold~     discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients~     assigned to additional active warming, the difference in cold discomfort change being~     statistically significant (p<0.05). Patients assigned to additional active warming also~     presented a statistically significant decrease in heart rate and respiratory frequency~     (p<0.05).~      In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive~     warming is an effective treatment to establish a slow rewarming rate and to reduce cold~     discomfort during prehospital transportation. However, the addition of active warming using~     a chemical heat pad applied to the torso will significantly improve thermal comfort even~     further and reduce the cold induced stress response.~   "
126472|NCT01400139|"~     The primary objective of this study is to characterize the long-term safety of Hydrocodone~     Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and~     nonneuropathic pain.~   "
126473|NCT01400126|"~     We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure~     water) in comparison with the use of conventional water which are used in most dialysis~     units worldwide. To the best of our knowledge prospective data in that field is sparse.~   "
126474|NCT01400113|"~     Our proposal is to administer asenapine to patients who are clinically agitated and in need~     of immediate intervention. At present there are no controlled studies that we know of that~     explores the use of asenapine for this purpose. Establishing the utility of asenapine for~     this common clinical problem will support its use as an additional treatment option in~     acutely agitated patients.~   "
126475|NCT01400100|"~     The aim of the study is to test the hypothesis that intraarterial bolus application of 500~     µg Octreotide in the gastroduodenal artery during the resectional phase of~     pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the~     pancreatic remnant.~      A primary end-point of the study is a change in pancreatic texture.~      A secondary end-point is the rate of postoperative pancreatic fistula.~   "
126476|NCT01400087|"~     The aim of this prospective randomized controlled trial is to assess the efficacy of~     cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy~     for trainees.~   "
126477|NCT01400074|"~     In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400~     mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal~     molecular response will be defined as patients who have achieved a complete cytogenetic~     response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first~     line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).~   "
126478|NCT01400061|"~     According to our experimental experiences w hypothesized that blood boron levels may be~     corralated to body mass index.~   "
126479|NCT01400048|"~     The purpose of the present study is to study the effect of aloe vera in the treatment of IBS~     patients in a randomized, double-blind placebo controlled study.~   "
126480|NCT01400035|"~     Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an~     open, randomized, multi-center control study~        1. Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of~          cerebral infarction~        2. Design Open, randomized, multi-center control study~        3. Trial Population:Patients with acute cerebral infarction~        4. Number of Subjects 720 patients in test group and 240 patients in control group,~          totally 960 patients will be recruited.~        5. Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and~          Citicoline 0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel~          sulfate tablets 75mg once a day.~           Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally~          oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.~        6. Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2~          Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2~          NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1~          Serology, hepatic and renal function examination 6.3.2 Adverse events~        7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.~   "
126481|NCT01400022|"~     Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital~     area. Any age group may be affected, although it is seen more often in postmenopausal women.~     The current gold standard treatment is topical ultrapotent corticosteroids such as~     clobetasol.~      Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the~     treatment of vulvar lichen sclerosus.~   "
126482|NCT01400009|"~     Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin~     medications that have caused muscle pain for them in the past.~   "
126483|NCT01399996|"~     In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium~     animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or~     after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time);~     2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human~     volunteers. In addition to providing information about the relative efficacy of the delivery~     vehicles on probiotic function it will provide novel information about the influence of the~     yogurt smoothie alone (control) on all the parameters measured.~   "
126574|NCT01398813|"~     In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer~     proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order~     to understand attitudes toward reproduction, potential treatments and genetic testing in~     order to improve the understanding of the decisions that XLHED carrier females make~     regarding their reproductive future.~   "
126484|NCT01399983|"~     The 6 minute walk (6MW) gives information about the exercise capacity and it is an important~     tool for clinical decisions and for the prognostic evaluation of PH patients. The test is~     technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation,~     heart rate, walking distance (in this study after every minute) and the level of dyspnea~     (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is~     evaluated. The test is sometimes criticized, because of the dependence on the patient's~     motivation.~      The purpose of the present study is to standardize the test by the incorporation of~     objective factors. The investigators are correlating the change of heart rate and dyspnea~     (BORG scale) with the achieved walking distance during subsequent examinations performed~     with different effort.~   "
126485|NCT01399970|"~     The purpose of the present study is to determine whether a mobile teledermatology care model~     can achieve better clinical outcomes as compared to conventional, outpatient care for the~     management of severe acne treated with isotretinoin.~      The superiority of mobile care in comparison to conventional, outpatient care will be~     investigated regarding~        1. effectiveness: Global evaluation Acne (GEA) score -response at week 24~        2. safety: drop out rates and medication side effects~        3. overall patient satisfaction with acne care and therapy~        4. overall physician satisfaction with mobile acne care~   "
126486|NCT01399957|"~     Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in~     persons with multiple sclerosis. This project seeks to determine if there are other benefits~     to taking dalfampridine besides an increase in walking speed. This is strictly an~     observational study and research staff will not be involved in any decisions to stop or~     start taking the medication.~   "
126487|NCT01399944|"~     This single-site, within-subject, experimental study is designed to test the hypothesis that~     individuals express taste receptors differently and have different sensitivities to bitter~     taste samples, which results from uneven expression. Subjects will include 100 racially and~     ethnically diverse, healthy adults. All subjects will provide saliva samples for genetic~     analysis and undergo taste testing with common psychophysical stimuli. From the pool of 100~     subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each~     homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two~     additional sessions. During both sessions the investigators will 1) measure bitterness~     thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of~     several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. The~     investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from~     saliva to evaluate molecular differences over time and between individuals and how it~     relates to taste psychophysics. All psychophysical and cellular measurements will be done~     during both sessions so that the investigators can determine how much variation is observed~     over a one-week time period in both cellular phenotype and psychophysical phenotype.~   "
126488|NCT01399931|"~     To assess specificity and overall accuracy of interim dual-point acquisition PET in~     predicting treatment outcome.~      The study is aimed at assessing the specificity of interim dual-point PET performed after 2~     ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients~     presenting bulky lesions at baseline.~   "
126489|NCT01399918|"~     The purpose of this study is to find out what effects, good and/or bad the combination of~     two medications, everolimus and bevacizumab, has on kidney cancer. In this clinical trial we~     are now testing these medications in combination. We think that both together might work~     better that either drug alone. Importantly, both of these drugs together have been tested in~     patients with a different type of kidney cancer and patients tolerated the combination well.~   "
126490|NCT01399905|"~     Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central~     nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous~     levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects.~      The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa~     effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75~     mg and the high dose is 450mg.~      Subjects will be recruited from the investigators clinic when they are seen for treatment~     for Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at~     the VA.~      Subjects will take part in 2 screening visits one week apart to determine eligibility.~     Subjects will be randomly chosen to start either high or low dose carbidopa and take it for~     4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are~     doing after starting this dose of study drug. We will leave them a message if we cannot~     reach them. If there are any problems, we will schedule them to come to the clinic within~     the next 2 days.~      Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2~     weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn~     and their Parkinson's disease assessed by a finger tapping exercise, timing their walking,~     and looking at their uncontrolled movements.~      The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be~     called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this~     dose of study drug. We will leave them a message if we cannot reach them. If there are any~     problems, we will schedule them to come to the clinic within the next 2 days.~      The outpatient visit and hospital admission will repeat again. At the end of the second~     hospital admission, treatment on the study is over and subjects will go back to their~     original Parkinson's disease medications. The study will end with a follow up phone call or~     clinic visit 2 - 4 weeks after the final hospital admission.~      Subjects will fill out a daily diary that asks about their movement throughout the day for 3~     days before they come to the Oregon Clinical and Translational Research Institute.~      Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is~     using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a~     different route than is normally given.~      Finger tapping rates will be compared between high and low dose study drug use to see if one~     group has slower rates than the other.~   "
126491|NCT01399892|"~     High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition~     Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay~     glucose absorption and reduce postprandial glycemic excursion. They also appear to have a~     beneficial effect on cholesterol levels. It has been shown, in few short term adult studies,~     that high fiber foods reduce postprandial blood glucose levels. The American Diabetes~     Association feels that there is little evidence confirming the positive effect of high fiber~     foods on blood glucose control. It is not clear whether a high fiber diet can improve~     glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that~     children with type 1 diabetes will benefit from having added fibers in their diet. The~     investigators plan to study blood glucose values using a continuous blood glucose monitor~     before and after dietary fibers are introduced. This will help us determine whether a diet~     rich in fiber should be recommended in all children with type 1 diabetes mellitus~   "
126492|NCT01399879|"~     The Scanning Kelvin Probe measures surface electrical potential without actually touching~     the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning~     Kelvin Probe measurements. This project will focus specifically on noise arising from~     physical movement and environmental electrical field.~   "
126702|NCT01397136|"~     In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in~     embryo culture medium, in order to investigate whether both cell-free nucleic acid types may~     provide additional, reliable, predictive parameters for embryo viability and implantation~     potential.~   "
126493|NCT01399866|"~     One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60~     to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment~     to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion~     criteria, and demonstrate response to cue reactivity at the screening visit, will either be:~        -  started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose~          of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which~          method to use to quit smoking will be based on participant choice as well as taking~          into account any medical contraindications to either therapy.~        -  evaluated to confirm abstinence from smoking. Recently abstinent participants referred~          by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10~          ppm to confirm abstinence.~      Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue~     Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study~     medication and cue exposure treatment, spaced five to nine days apart. Subjects will~     complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire~     study involves twelve visits and will last approximately ten weeks. For recently abstinent~     participants referred by a smoking cessation clinic, PCP or self referred, the study~     involves 7 visits (screening and baseline visit will be merged into one and there is no CBT~     component) and will last approximately 7 weeks.~   "
126494|NCT01399853|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children~     caused by viruses that belong to the enterovirus genus of the picornavirus family. Although~     most HFMD cases do not result in serious complications, outbreaks of HFMD caused by~     enterovirus 71 (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused~     by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month~     in Jiangsu Province in China. The data from the phase I study suggested that the inactivated~     EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese~     children and infants. In order to provide more evidence for the immunogenicity of the~     vaccine, to further explore the probable immunizing dose and the safety profile of this~     vaccine, a phase II clinical trial is planed to conduct.~   "
126495|NCT01399840|"~     This is a two-arm, open-label study to determine the maximum tolerated dose (MTD) and assess~     the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMN 673 in~     patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic~     Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Arm 1 will enroll patients with~     either AML or MDS; Arm 2 will enroll patients with either CLL or MCL.~   "
126496|NCT01399827|"~     The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the~     treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention~     Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3~     fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects~     of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant~     treated ADHD adults, and d) predict value of fatty acids present in RBC cell membranes. This~     study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of DESR.~   "
126497|NCT01399814|"~     The purpose of this study is to find out whether perioperative fluid restriction influence~     on postoperative immunological function. And discuss the probable mechanism that fluid~     restriction regime effect on clinical data.~   "
126498|NCT01399801|"~     The purpose of this study is to determine if optimal lead placement, guided by the largest~     improvement in aortic flow measured by Doppler will:~        1. Improve the way the heart's left ventricle functions~        2. Decrease the number of hospital admissions for heart failure related symptoms~        3. Reduces uncoordinated heart contractions~        4. Improve quality of life as measured by the Minnesota Living with Heart Failure~          Questionaire and NYHA Class assessed after six months~   "
126499|NCT01399788|"~     This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against~     reference drug in healthy volunteers.~   "
126500|NCT01399775|"~     1. Evaluation of dimensional changes in alveolar ridge following immediate implantation~          compared to delayed implantation~        2. evaluation of the effect of gap dimensions between socket walls and dental implant in~          implant stability~   "
126501|NCT01399762|"~     The purpose of the Endostroke Registry is to gather information on predictors of good or~     poor clinical outcome following mechanical recanalization therapies for acute ischemic~     stroke.~   "
126502|NCT01399749|"~     The objective of our study is to compare the safety and effectiveness of the use of~     autologous cultured adipose tissue-derived stem cells versus cultured autologous~     chondrocytes for the treatment of chondral knee lesions.~   "
126503|NCT01399736|"~     The Compare-Acute trial is a prospective randomised trial in patients with multivessel~     disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The~     purpose of the study is to compare a FFR guided multivessel PCI taking place during the~     primary PCI with a primary PCI of the culprit vessel only.~      Patients will be enrolled after successful revascularisation of the culprit vessel. Patients~     that have at least one lesion with a diameter of stenosis of more than 50% on visual~     estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related~     artery, will be randomised either to the FFR guided complete revascularisation arm or staged~     revascularisation by proven ischemia or persistence of symptoms of angina.~      Approximately 885 patients will be entered in the study.~      Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting~     stenoses in the non-IRA performed within the same procedure as the primary PCI or within the~     same hospitalisation will improve clinical outcomes compared to the staged~     revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the~     guidelines.~   "
126504|NCT01399723|"~     This study seeks to determine whether clinical outcome following initial treatment of severe~     pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin.~     The study will also provide an estimate of the proportion of Kenyan children with severe~     pneumonia who fail treatment with a single antibiotic.~   "
126506|NCT01399697|"~     This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra~     monotherapy in patients with rheumatoid arthritis and an inadequate response to~     methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4~     weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week~     16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus~     either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.~   "
126507|NCT01399684|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed~     to estimate the efficacy of MEGF0444A treatment to disease progression, combined with~     oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in~     participants with metastatic colorectal cancer (CRC).~   "
126508|NCT01399671|"~     Major depression is characterized by vestibular anomalies. The investigators hypothesized~     that vestibular stimulation will improve depression symptoms in major depression patients.~   "
126509|NCT01399658|"~     Standard therapy for gynecologic cancers involves the use of brachytherapy, also called~     internal radiation therapy or implant radiation. The treatment being studied consists of~     standard brachytherapy with the additional use of MRI to guide the insertion of radioactive~     applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is~     practical and beneficial when compared to the standard CT-guided brachytherapy placement.~     The investigators are hoping that this MRI procedure will decrease the risk of giving too~     high a radiation dose to the bladder or bowel.~   "
126510|NCT01399645|"~     This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty~     liver who are resistant to metformin, treatment with liraglutide in combination with~     metformin will cause an absolute reduction in liver fat superior to insulin-metformin~     treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).~   "
126511|NCT01399632|"~     Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely~     to get heart disease than those who have normal or high levels. Dietary fat, whether the~     harmful type (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary~     carbohydrate lowers HDL. The investigators are doing this research study to find out why the~     amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate.~     The investigators will trace the ability of the HDL in a person's blood to take up~     cholesterol, get bigger, and then leave the blood by passing into the liver. The~     investigators want to know if dietary unsaturated fat improves the ability of HDL to do this~     compared to dietary carbohydrate.~   "
126512|NCT01399619|"~     the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12~     or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to~     re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or~     continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV~     treatment-naive or relapsers patients coinfected with HIV~   "
126513|NCT01399606|"~     This is a multicentric International Phase III,Long term open label study(12~     months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment~     of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.~   "
126514|NCT01399593|"~     The purpose of this trial is to determine the safety and efficacy of eculizumab in the~     prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring~     desensitization therapy.~   "
126515|NCT01399580|"~     Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter~     Study. The study objectives are to evaluate efficacy and safety, including thoracic~     bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose)~     compared to placebo in type 2 diabetic subjects with nephropathy who are receiving the~     maximum tolerated labeled daily dose of a RAS inhibitor.~   "
126516|NCT01399567|"~     Pain assessment and management deficiencies in nursing homes (NHs) are well documented.~     Unrelieved pain in this setting results in poorer resident outcomes, including depression,~     decreased mobility, sleep disturbance, and impaired physical and social functioning. This~     randomized controlled trial will evaluate the efficacy of a pain management algorithm~     coupled with intense diffusion strategies in improving pain, physical function and~     depression among NH residents. Specific aims of the study are to: 1) Evaluate the~     effectiveness of a pain management algorithm (ALG) coupled with intense diffusion~     strategies, as compared with pain education (EDU) and weak diffusion strategies, in~     improving pain, mobility, and depression among NH residents; 2) Determine the extent to~     which adherence to the ALG and organizational factors are associated with changes in~     resident outcomes and the extent to which changes in these variables are associated with~     changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables~     at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain~     in severely cognitively impaired residents who are unable to provide self-report.~   "
126517|NCT01399554|"~     Alcohol use disorders are common and few individuals with the disorder ever seek help. This~     study proposes to intervene in a novel way - exercise, as it has many mental and physical~     health benefits and is an activity that is incompatible with simultaneous alcohol use. If~     effective, this non-stigmatizing intervention may increase the utility and acceptability of~     interventions for alcohol use disorders and ultimately increase the number of individuals~     effectively treated.~   "
126518|NCT01399541|"~     The specific aims of this translational, interdisciplinary, multi-center, international~     research study with 300 Lung cancer patients are to:~      Aim 1 Explore how the patients experience the transfer between different locations and~     between different levels of care at the same location and how they experienced coming home.~      Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and~     symptom clusters over time.~      Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health~     related quality of life and social support.~   "
126550|NCT01399125|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon®~     patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory~     submission and registration of Exelon transdermal patch in China. The study is designed to~     confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size)~     versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease~     Assessment Scale-Cognitive Subscale (ADAS-Cog).~   "
126519|NCT01399528|"~     This is an observational study exploring the genetics of lacosamide response. The study will~     last 3 years and has been divided in to three stages; 1) recruitment, 2) observational~     phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their~     baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18~     months with an assessment (via interview and where possible seizure diaries) of seizure~     frequency and other treatment related phenotypes every 3 months. The recruitment period will~     span months 1-12, the observational period will span months 1-30 and analysis of data will~     be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.~      Primary objective: To determine the clinical relevance of genetic variation in predicting~     lacosamide responsive and non-responsive patients.~      Secondary objectives: To determine the clinical relevance of genetic variation in~     predicting:~        -  Optimal dose of lacosamide~        -  Adverse drug reactions to lacosamide~   "
126520|NCT01399515|"~     The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to~     slow the progression of visual function and/or to improve the visual function in patients~     with retinitis pigmentosa (RP).~      Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily~     for 48 weeks. Visual function and safety will be assess before and after treatment (48~     weeks) between valproic acid and control groups.~   "
126521|NCT01399502|"~     The purpose of this study is to investigate the effectiveness of health promotion emails for~     depression. It is hypothesised that emails containing self-help advice will improve~     depression symptoms more than emails containing information about depression.~   "
126522|NCT01399489|"~     The current study is designed to examine the impact of 16 weeks of moderate intensity~     aerobic training on arterial stiffness and blood pressure in stage 3 chronic kidney disease~     (CKD) patients. The investigators hypothesize that short term aerobic training will improve~     the stiffness of arteries in CKD patients.~   "
126523|NCT01399476|"~     This is a study of the safety and efficacy of a new surgical procedure using endoscopic~     instruments and a tunneling technique to reach the LES for dissection. We hypothesize that~     this technique provides an incisionless, less invasive option with similar functional~     outcome compared to standard Heller myotomy.~   "
126524|NCT01399463|"~     The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting~     Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel~     disease and side branches by pressure wire guided percutaneous coronary intervention.~   "
126525|NCT01399450|"~     The purpose of this study is changing (improving), after initiating various doses of~     Paliperidone ER on schizophrenia patients.~   "
126526|NCT01399437|"~     Background:~      - A special brain circuit is important for helping us keeping an eye open for things that~     are going on around us, even when we are not directly paying attention to them. This circuit~     seems to work differently in people with schizophrenia than in other people, which may~     explain specific deficits with broad monitoring observed in people with schizophrenia.~     Researchers want to compare brain function in people with schizophrenia and healthy~     volunteers to find out more about how these brain circuits work and affect attention.~      Objectives:~      - To study how the brain performs broad visual monitoring in people with schizophrenia.~      Eligibility:~        -  Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.~        -  Healthy volunteers between 18 and 55.~      Design:~        -  Participants will be screened with physical and psychological exams. They will have a~          medical history. Tests for drug and alcohol use will also be done.~        -  Participants will have two study visits. The first is a training visit and the second~          is a scanning visit.~        -  At the training visit, participants will practice computer-based tests of focus,~          memory, and concentration. They will also answer questions about mood, psychiatric~          symptoms, and smoking habits.~        -  At the scanning visit, participants will perform the computer-based tasks that they~          practiced at the training visit. They will have magnetic resonance imaging while they~          perform these tasks.~   "
126527|NCT01399424|"~     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a~     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide~     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the~     LPS (O-SPC). The O-SPC is covalently bound to the non-toxic recombinant diphtheria toxin~     mutant (rDT).~      The objective of this phase of the study is to determine if this vaccine is safe and can~     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective~     is to determine if this vaccine can elicit higher levels of IgG antibody than the previous~     experimental vaccines made with the full length O-SP, shown to be > 70% efficacious in~     greater than or equal to 3 year old children. Higher levels of IgG anti O-SP are expected to~     induce type specific immunity to shigellosis in younger children.~      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be~     vaccinated on a random basis with one i.m. injection of 10 or 25 ug of the investigational~     conjugate vaccine. Local and systemic reactions will be observed at 30 minutes, and the~     volunteers will be instructed to take their temperature and examine the injection site for~     redness and swelling and fill out a questionnaire at 6, hours and daily for 7 days after~     vaccination. The volunteers will visit the clinic at 24 or 48 hours following the injection~     and any time they request it. The study will commence with 5 volunteers injected with the~     10ug dose to be followed, if no severe adverse reactions occur, by 5 volunteers injected~     with the 25ug dose. If a severe adverse reaction occurs on 1 of the 5 volunteers in either~     group, 5 more will be injected with that dose. If there are no severe adverse reactions the~     study will proceed. If there is one more severe reaction the study will be halted and~     re-evaluated by the IRB and the FDA.~      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and~     compared to those elicited by our previous S. sonnei conjugate vaccines.~      There is a body of evidence that a critical level of serum IgG antibody to the O-specific~     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other~     Shigella:~        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious~          explanation for this is that maternally-derived serum IgG provides this immunity;~        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,~          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric~          bacteria;~        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age~          when the maternally-derived serum anti-O-SP has waned and the naturally-derived~          antibodies have not yet appeared;~        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against~          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis~          showed significantly lower serum IgG responses to the homologous LPS than those did~          not.The high antibody level induced by the conjugate vaccine indicates the positive~          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;~        5. Following Phase 1 and Phase 2 studies that showed safety and age-related~          immunogenicity, a double-blinded randomized and vaccine-controlled Phase 3 evaluation~          of S. sonnei and S. flexneri type 2a O-specific polysaccharide (O-SP) protein~          conjugates was conducted among 1-4 year-olds in Israel.~      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old~     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no~     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum~     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels~     declined rapidly several months after the last injection. Our interpretation is that the~     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP~     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of~     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by~     our S. sonnei O-SP.~      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound~     by their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages~     between the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and~     aminooxy linkers bound to the carrier. The coupling reaction was carried out at a neutral pH~     and room temperature. The carrier protein was a non-toxic recombinant diphtheria toxin~     mutant. IgG antibody levels induced in young outbred mice by this new S. sonnei O-SPC~     conjugate were significantly higher then those elicited by the O-SP conjugates.~   "
126528|NCT01399411|"~     Background:~      - The Agricultural Health Study (AHS) is looking at the long-term health effects of farming~     exposures including pesticides, crops, and animals. The chronic health effects of exposure~     to pesticides are easier to study in farmers and their spouses. They know what chemicals~     they use and tend to live in the same place for most of their adult lives. AHS participants~     are expected to report any changes in their health. This includes any new medical~     conditions. Researchers want to follow up on these reports to confirm their accuracy.~      Objectives:~      - To follow up AHS participants who have self-reported that they have a new disease and~     confirm their diagnosis.~      Eligibility:~      - Current AHS participants.~      Design:~        -  Researchers will confirm self-reported changes in medical conditions by contacting the~          AHS participant to ask for more information.~        -  The AHS participant will give permission for researchers to contact their doctor to~          look at their medical records. They will also be asked to provide a cheek swab or~          saliva sample.~        -  Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other~          diseases will be followed up in the future. Other diseases will be followed up in the~          future.~   "
126536|NCT01399307|"~     Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large~     therapeutic potential for many rare and common diseases that impacts millions of patients~     worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to~     extract with minimally invasive procedures such as elective liposuction in large quantities~     and therefore may be a cost effective source for cellular therapies in a wide range of~     medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell~     Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by~     performing histology, various cell counts, multiple surface marker tests and measurement of~     the residual amount of digestive enzymes as a safety measure for human clinical trials.~   "
126570|NCT01398865|"~     The purpose of this study is to find out more about the brain's response to selective~     serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder~     (BDD). The investigators will use positron emission tomography (PET) and Magnetic Resonance~     Imaging (MRI) scans to look at brain activity in people with BDD before and after treatment~     with an SSRI. The investigators hope that what is learned will allow prediction of whether~     someone will improve with SSRI treatment.~   "
126529|NCT01399398|"~     Background:~      - The cannabinoid type 1 (CB1) receptor is a protein found on some brain cells. It may play~     a role in obesity or some psychiatric disorders such as schizophrenia. Imaging studies like~     positron emission tomography (PET) can show where CB1 receptors are located. A new~     radioactive chemical, 11C-SD5024, may be able to show these receptors more clearly than~     previous radioactive chemicals. Better images of CB1 receptors in the brain may help improve~     our understanding of obesity and psychiatric disorders. This information may lead to better~     treatments.~      Objectives:~      - To test how well a new radioactive chemical, 11C-SD5024, is taken up by the brain during~     imaging studies.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age who are able to have positron emission~     tomography scans.~      Design:~        -  All participants will be screened with a physical exam, medical history, and blood~          tests.~        -  Participants will be in one of three groups for the study. Each group will receive~          11C-SD5024 and have a different set of imaging studies.~        -  Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain.~          They will also have blood and urine tests.~        -  Group 2 will have a whole-body PET scan, as well as blood and urine tests.~        -  Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain.~          They will also have blood and urine tests. The two PET scans can happen on the same day~          or on two different days.~   "
126530|NCT01399385|"~     Background:~      - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about~     heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing~     and vessel wall thickness. This information may help diagnose and treat heart disease and~     other conditions that lead to heart attacks. Better MRI methods are needed to improve heart~     disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new~     techniques to improve the quality of heart MRI, compared with more complex studies like~     catheterization or angiography.~      Objectives:~      - To compare heart MRI techniques with other tests used to diagnose heart disease.~      Eligibility:~      - People at least 18 years of age who either have or may have heart disease, or are healthy~     volunteers.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  They will have an angiography to study the inside of blood vessels. This test is an~          x-ray study of the blood vessels. It will be done either separately or as part of a set~          of tests to diagnose possible heart disease.~        -  Participants will have at least one and up to five MRI scans. The scans will involve~          different methods of studying the heart and blood vessels. Participants may also have a~          computed tomography scan to confirm the findings of an MRI scan.~        -  No treatment will be provided as part of this protocol.~   "
126531|NCT01399372|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.~     Others interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill~     cancer cells. It is not yet know whether rituximab and combination chemotherapy are more~     effective when given with or without radiation therapy in treating patients with primary~     central nervous system lymphoma.~      PURPOSE: This randomized phase II trial studies how well giving rituximab and combination~     chemotherapy with or without radiation therapy works in treating patients with primary~     central nervous system lymphoma.~   "
126532|NCT01399359|"~     RATIONALE: Learning about how patients make decisions about using chemoprevention may help~     doctors plan treatment in which more patients are willing to choose chemoprevention to~     reduce their breast cancer risk.~      PURPOSE: This clinical trial studies factors influencing decision-making about the use of~     chemoprevention in women at increased risk for breast cancer.~   "
126533|NCT01399346|"~     Rationale: For the development of a closed loop system, faster insulin absorption after~     bolus administration could help to reduce the system's delay and thus increase patient~     safety. It has been shown that regular insulin absorption is faster when injecting insulin~     with a sprinkler needle (containing holes in the walls and being sealed at the tip). The~     current study will evaluate the impact of different application volumes on pharmacokinetic~     and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart).~      Objective: To compare the pharmacokinetic response (based on the time to maximum observed~     serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart~     after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in~     patients with type 1 diabetes.~      Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study.~      Population: Twelve type 1 diabetic subjects~      Intervention: The investigational treatment is the subcutaneous administration of insulin~     aspart either as one bolus of 18 IU at one injection site or as 9 separately and~     simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma~     samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an~     8-hour clamp experiment. Patients will undergo both investigational treatments in a~     randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.~      Main study endpoint: Time to maximum observed serum insulin aspart concentration.~   "
126534|NCT01399333|"~     The purpose of this research study is to compare the varying qualities of protein~     supplements utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method~     and evaluating the clinical outcome related to protein stores and absorption.~   "
126535|NCT01399320|"~     Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety~     of problems, including infection/abscess and the development of a chronic sinus cavity.here~     we try a minimmally invasive method for managing such condition~   "
126548|NCT01399151|"~     Hypothesis:~      Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or~     high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production~     of anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory~     cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell~     response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose~     vitamin D supplements (400 IU per day).~   "
126549|NCT01399138|"~     The purpose of this study is to examine the effects of a blueberry powder on insulin~     sensitivity, blood pressure, and vascular reactivity in subjects with metabolic syndrome.~   "
126537|NCT01399294|"~     Constipation is a common problem in palliative cancer patients. However, there were~     insufficient randomized controlled trial (RCT) data to identify the best laxative or~     combination of laxatives in these patients.~      Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients.~     More than half had received at least one form of TCM therapy according to the survey carried~     in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging~     effects simultaneously may be more preferred to relieve constipation by local palliative~     cancer patients.~      TCM syndrome differentiated by collecting all symptoms and signs through the classic four~     diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.~      The present study is the first local study to evaluate the bowel habits and TCM syndrome of~     advanced cancer patients with constipation. We hope that the results not only can shed light~     on patient's own reporting or experience of constipation and the effectiveness of current~     practice, but also can draw up a CHM formulation for advanced cancer patients with~     constipation.~   "
126538|NCT01399281|"~     BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric~     rheumatic disease (PRD) and an important cause of short and long-term disability. Although~     none of the available drugs for JIA has a curative potential, prognosis has greatly improved~     as a result of substantial progress in disease management. The therapeutic treatment of~     children with JIA encompasses the use of NSAIDs and intra-articular steroid injections. In~     those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying~     anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX,~     biologic agents recently have become treatment options.~      PATIENTS AND METHODS: 3-10 year observation study related to children with JIA undergoing~     treatment with MTX or biologic agents with the following objectives:~        1. To create a long-term observational registry of a large population of prevalent and~          incident cases.~        2. Use the accumulating data in the registry to conduct (i) a pharmacovigilance/safety~          study (primary endpoint) and (ii) estimate effectiveness (frequency and magnitude of~          response, disease activity over time inhibition or slowing of joint erosions and other~          radiological evidence of disease progression,), and (iii) estimate adherence to the~          various treatment regimens. Data from the registry will be used to compare safety and~          effectiveness profiles amongst the patient cohorts.~        3. To identify clinical and laboratory predictors of safety, response to therapy,~          including remission This project has retrospective (first 3 years) and prospective~          components (up to 10 years) and will be conducted by the participating centres of the~          more than 50 countries belonging to the Paediatric Rheumatology INternational Trials~          Organisation (PRINTO certified ISO 9001-2008, www.printo.it), or the Pediatric~          Rheumatology European Society (PRES at www.pres.org.uk). The main role of these~          organisations is to provide a scientific basis for current treatments of paediatric~          rheumatic diseases.~      The overall hypothesis to be tested is:~      • Biologic agents ± MTX agents are able to maintain an acceptable safety profile in the long~     term in children with different JIA categories while achieving clinical remission and~     prevent/stop joint erosion development over time.~      The overall aims are to establish the long term safety of biologic agents and MTX, and their~     relative effectiveness in children with JIA who need treatment with second line agents.~   "
126539|NCT01399268|"~     Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a~     major marker of inflammation is known to increase during total joint replacement surgery.~     IL6 has been found to be elevated postoperatively in patients with hip fractures and has~     been linked to mental status changes and possibly other complications. It is known to lead~     to shock and participate in the inflammatory state seen in sepsis. High levels have further~     been linked to postoperative fever, confusion, symptoms of depression, acute respiratory~     distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found~     that low dose steroids given in two doses in the initial perioperative period decreased the~     amount of IL6 released compared to placebo, but this was not sustained past 24 hours.~      Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in~     urine samples. It is considered to be a marker of lung injury and is found to be elevated in~     patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the~     investigators have found that urine desmosine levels rise with bilateral total knee~     replacement compared to unilateral total knee replacement indicating possible lung injury.~      Therefore the investigators hypothesize:~      Continued low dose steroids given three times over a 24 hour period will:~        1. Significantly decrease peak IL6 cytokine release during bilateral total knee~          replacement and maintaining this reduction in IL6 beyond 24 hours.~        2. Decrease urinary desmosine levels, and hence be protective of lung injury.~   "
126540|NCT01399255|"~     The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro~     formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic~     parameter (PK) and the pharmacodynamic parameter (PD).~   "
126541|NCT01399242|"~     The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus~     corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic®~     plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate~     (cGFR) from baseline to month 12.~      The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute~     rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in~     patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal~     at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus~     corticosteroids.~      Patients will be submitted to monthly GFR determination but, for group comparison, only the~     GFR measured at month 12 and month 24 of renal transplantation will be used.~   "
126542|NCT01399229|"~     This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor®~     (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term~     pregnant patients.~   "
126543|NCT01399216|"~     We aim to determine whether a supplement containing fucoidan isolated from Mekabu~     (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body~     temperature in subjects with low basal body temperature.~   "
126544|NCT01399203|"~     To investigate the predictive value of the contrast media volume to creatinine clearance~     (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and~     to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI~   "
126545|NCT01399190|"~     This prospective observational study will evaluate the efficacy and safety of bevacizumab in~     combination with capecitabine and oxaliplatin as first-line treatment in participants with~     colorectal cancer. Data will be collected from each participant until disease progression~     occurs (for up to 30 months).~   "
126546|NCT01399177|"~     The purpose of this study is to find out if there is any change in diet on food cravings and~     weight loss in the 12 months following bariatric surgery.~   "
126547|NCT01399164|"~     To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in~     subjects with proton pump inhibitor induced achlorhydria.~   "
126571|NCT01398852|"~     The purpose of this research study is to evaluate the long tern safety and effectiveness of~     cross-linking in eyes with keratoconus and ectasia.~   "
126551|NCT01399112|"~     The investigators propose to recruit patients who have experienced a recent first episode of~     psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective~     Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify~     themselves as a current cigarette smoker. Aiding this population with smoking cessation is~     crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke,~     which is leading to early mortality. While these individuals can benefit from standard~     evidence-based treatment, these treatments are underutilized. Web based programs, such as~     the EDSS and thetruth.com, can provide education and motivational tools to help people with~     a recent onset of psychosis use evidence-based smoking cessation treatments. This study aims~     to test these two web-based programs among young people with a recent episode of psychosis~     for usability and likeability and to explore whether use of these two programs will motivate~     users to seek smoking cessation treatment or to engage in other quitting behaviors in the~     month following use of the programs. Information gathered from this proposal will be used to~     help the researchers decide whether either of these two programs will be reasonable to~     include in a larger study of a comprehensive treatment for individuals with first episode~     psychosis.~   "
126552|NCT01399099|"~     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne~     is conducting this research to study whether the investigational dressing, called the~     Neodyne Dressing, can minimize scar formation in a simple manner.~   "
126553|NCT01399086|"~     This is a retrospective chart-review study that will be based on the collection of data from~     electronical or paper-based medical records with available data on patients who have~     commenced treatment with fulvestrant after January 1st of 2007. All necessary information~     for the purposes of the present study will be collected with the use of a paper-Case Record~     Form.~   "
126554|NCT01399073|"~     Compared to the classical paper and pencil-tests, testing patients in our virtual reality~     setup might have a higher sensitivity and specificity.~   "
126555|NCT01399060|"~     This single-site, within-subject, experimental study is designed to test the hypothesis~     children who live in a household in which one or both of their parent smoke will exhibit a~     higher cough threshold and will prefer more intense sweet tastes than children who live in a~     household where neither parent smokes. Subjects will include at least 50 racially and~     ethnically diverse, healthy children aged 10 to 17 years (a critical time for experimenting~     with tobacco) and a parent. The sample will comprise two groups: Non-Environmental Tobacco~     Smoke (ETS) Exposed (neither the child nor parents has ever smoked or been exposed to~     environmental tobacco smoke (ETS) in the home), and ETS-Exposed (the parent has smoked at~     least 3 cigarettes per day for at least five years in the home, with the child living in the~     home continuously). Cough sensitivity will be measured using a standard single-inhalation~     challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot~     peppers) needed to elicit cough. Sweet taste preferences will be measured using a~     forced-choice paired comparison method of liquids which differ in sucrose content. Measures~     of breath carbon monoxide will validate the smoking status of parents and their adolescent~     children. The key comparison will be between Non-ETS Exposed and ETS-Exposed children, with~     the difference between smoking and non-smoking parents as a positive control. Because~     smoking and non-smoking families may differ in ways besides tobacco exposure, the~     investigators will obtain health histories (with a focus on respiratory illness), smoking~     histories, measures of body weight, diet, and responses to personality tests (including~     susceptibility to addiction). The investigators will also obtain genomic DNA from saliva~     samples. Genes for chemosensory receptors that are part of the cough reflex pathway and~     genotype may account for aspects of cough sensitivity.~   "
126556|NCT01399047|"~     The primary objective of this trial is to establish the safety and tolerability of~     short-term (8 weeks) administration of mycophenolate mofetil in ambulatory children with~     JNCL. The secondary objective is to gather preliminary evidence of the short-term (8 week)~     impact of mycophenolate mofetil on clinically relevant features of JNCL as measured by the~     Unified Batten Disease Rating Scale (UBDRS), including motor features, seizures, behavior,~     cognitive and functional measures.~      Funding source-FDA Office of Orphan Product Development (OOPD).~   "
126557|NCT01399034|"~     The overall goal of this research is (1) to identify changes in gene expression and DNA~     methylation status in subjects who exhibit advanced chronic periodontal inflammation and (2)~     to identify microRNAs (miRNAs) and the interactive pathways associated with obesity as a~     modifier of periodontal infection pathogenesis.~   "
126558|NCT01399021|"~     There is no standard of care of management following parotidectomies. Most practitioners~     however place a drain (usually a flat Davol closed suction drain/ Hemovac in the~     investigators institutions) in the wound bed at the end of the procedure, which is usually~     removed the day following the surgery, or when the drain output reaches a subjective number~     (depending on surgeon preference). The investigators hypothesis is that there is no~     difference in hematoma/bleeding or infection rate when post parotidectomy drains are removed~     in the recovery area on the day of the surgery prior to discharge, compared to drains that~     are kept in place for at least 1 day or until drainage is less than 50 cc/24 hrs. The~     investigators would therefore like to undergo a randomized control clinical trial to assess~     the rate of significant hematoma formation and infection, the need for readmission and~     length of admission secondary to these complications when comparing 2 groups: one where~     drains are removed prior to discharge from the recovery area and the other where the~     patients are discharged with the drain and seen the next post operative day in the office.~     The drain output will then be measured and the drain taken out.~   "
126559|NCT01399008|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in~     combination with allopurinol compared to allopurinol alone when administered orally once a~     day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol~     alone.~   "
126560|NCT01398995|"~     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but~     problems with metabolism and blood glucose control can make this difficult. Some people with~     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous~     insulin infusion (CSII) therapy, in which a background or basal level of insulin is~     constantly infused under the skin by a special pump, with bolus doses of insulin given to~     accompany food. Clinical experience suggests that this may be particularly useful for~     managing diabetes for exercise, but there is limited experimental evidence to support this.~     The aim of this research , which is divided into three parts, is to investigate the~     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person~     with type 1 diabetes treated with CSII, can be made to approximate more closely to the~     physiological response of a healthy individual by a prior reduction of their basal insulin~     infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion~     rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose~     (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have~     an immediate effect on levels of insulin in the body, and evidence from adults suggests that~     the level of insulin in the bloodstream at the start of exercise is an important factor in~     whether hypoglycaemia develops during exercise. This suggests that reducing the basal~     insulin infusion rate some time before exercise may be useful. The aim of this study is to~     compare the effect of a basal insulin reduction on blood glucose levels between visits when~     this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90~     minutes before. The null hypothesis to be tested is that there is no difference between~     these conditions.~   "
126561|NCT01398982|"~     Breast reconstruction using a patient's own abdominal tissue is one of the most common~     methods for restoring mastectomy defects for breast cancer patients. Despite its increasing~     popularity and safety, the abdomen remains a major source of postoperative pain. Adequate~     pain control is important as it has been shown to reduce medical complications, in-hospital~     death, shortens hospital stay, lessen chronic pain and disability, and in turn lower~     health-care costs. The current postoperative pain relief protocol consists primarily of a~     patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause~     numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties,~     bladder and bowel dysfunction. A promising approach to provide postoperative pain control of~     the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral~     nerve block. Although the TAP block has been found to be an effective pain-relief following~     major abdominal surgeries, its use has never been studied for breast reconstruction using~     abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a~     TAP block in reducing postoperative abdominal pain following abdominal tissue breast~     reconstruction. This study has significant implications in improving both clinical care and~     health outcomes in patients undergoing this common method of breast reconstruction~     technique.~   "
126562|NCT01398969|"~     The goal of this study is to determine the outcome of patients with recurrent CDI treated~     with fresh HBT versus frozen-and-thawed HBT in a randomized controlled trial. The specific~     objectives are to evaluate the safety of both types of HBT and to compare the clinical~     response, treatment failure and relapse rate in patients treated with fresh HBT compared to~     those treated with frozen-and-thawed HBT; also to assess the functional health and~     well-being of patients in each arm using a validated tool. The metagenomics will also be~     conducted from the stool samples collected from select patients from each arm: pre and post~     treatment and the matching donors. The metagenomics data will be used to determine the~     bacteria which may have contributed to the cure of CDI.~   "
126563|NCT01398956|"~     The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are~     judged to benefit from continued treatment with Levetiracetam by the investigators and who~     are willing to continuously receive this drug.~   "
126564|NCT01398943|"~     More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular~     disease than direct pulmonary complications. Inflammation and oxidative stress,~     characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO)~     bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet~     to be determined. Thus, the overall objective of this proposal is to identify the role of NO~     bioavailability in contributing to vascular endothelial dysfunction in patients with COPD~     and to provide insight into the molecular mechanisms involved. Our central hypothesis is~     that inflammation and oxidative stress, both independently, contribute to the reduction in~     NO bioavailability and vascular endothelial dysfunction in patients with COPD.~   "
126565|NCT01398930|"~     The objective of this study is to assess the efficacy of acupuncture as an adjunctive~     therapy to pharmacological treatment of chronic pain due to knee osteoarthritis, as well as~     for, the improvement of physical functioning, reduction of stiffness, and improvement in~     quality of life. This is a 3-armed single-blinded randomized sham-controlled trial,~     comparing acupuncture along with pharmacological treatment, sham acupuncture including~     pharmacological treatment, and pharmacological treatment alone. One-hundred and twenty~     patients with knee osteoarthritis were randomly allocated to 3 groups. Group I was treated~     with etoricoxib, Group II was treated with acupuncture and etoricoxib, and Group III was~     treated with sham acupuncture and etoricoxib.~   "
126566|NCT01398917|"~     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract~     of unknown origin. Around 50% of patients develop during their disease course narrowing of~     the main bile duct with corresponding increase in symptoms such as itching, jaundice and~     abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion~     of a plastic endoprosthesis. However, it is not known which of these two therapeutic~     modalities is best. This study aims to compare both techniques in order to determine which~     is best in terms of postponing recurrence of the narrowing, safety and costs.~   "
126567|NCT01398904|"~     Body Dysmorphic Disorder (BDD) participants will demonstrate greater attentional biases as~     compared to healthy control (HC) participants. Greater attention bias will be associated~     with greater distress. Greater attention bias will be associated with greater symptom~     severity.~   "
126568|NCT01398891|"~     This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for~     suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase~     enrollment rates and obtain information for patients with a wide range of diagnoses and~     illness severity. Enrolled subjects will complete randomly-selected positive psychology~     exercises daily (on weekdays) until discharge and will rate the exercises in multiple~     domains. Subjects' participation will be complete at the end of their admission or when all~     exercises have been completed, whichever comes first.~      Overall, our goal is to assess the acceptability and utility of eight possible positive~     psychology interventions related to gratitude, optimism, kindness, mindfulness,~     recollection, and forgiveness in suicidal inpatients.~      This is a single-arm study, completed with patients who have been admitted to the hospital~     for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology~     treatment aimed at suicidal patients. The study consists of serial completion of different~     positive psychology exercises, once daily, during admission, to get subjects' input on their~     feasibility and impact. This will allow us to work collaboratively to identify the specific~     exercises that best fit this population. Subjects' participation ends when they are~     discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and~     total) in this study.~   "
126569|NCT01398878|"~     The purpose of this study is to determine the impact of eliminating traditional resident~     work shifts (i.e. greater than 24 hours in length) on patient safety and resident~     educational outcomes. In addition, the investigators will explore with key stakeholders~     (patients and their families, nurses, resident physicians and attending physicians) their~     experiences when residents are undertaking shifts greater than 24 hours in length as~     compared to 16 hours or less.~   "
126572|NCT01398839|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     corneal collagen cross-linking (CXL) when used to treat ectasia.~   "
126575|NCT01398800|"~     Long term follow-up is needed to determine whether current Mobile Bearing revision Total~     Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of~     mobile bearings in the revision TKA setting include reduction in polyethylene wear,~     decreasing fixation stresses, and protection of the constraining mechanisms. Several studies~     have reported satisfactory clinical results after revision total knee arthroplasty but no~     study with a large number has specifically addressed the clinical outcomes after revision~     total knee arthroplasty using the mobile bearing design~   "
126576|NCT01398787|"~     The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS~     contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK®~     COLORBLENDS contact lens wearers.~   "
126577|NCT01398774|"~     The investigators would like to learn more about the metabolic consequences of~     pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition.~     People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better~     understand the cause of overweight or obesity, investigators are measuring body composition~     and resting energy expenditure (REE), which is the amount of calories burned while~     completely at rest. The investigators also want to determine the amount of body fat.~   "
126578|NCT01398761|"~     The purpose of this grant is to fund the research necessary to fully understand the impact~     of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care.~     This information will inform exactly how Partners will move ahead with tools to improve~     handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners~     wide, or abandoned in favor of other solutions). The investigators hypothesize that a~     web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and~     measures of continuity of care compared with current handoff tools.~   "
126579|NCT01398748|"~     Excessive free radical formation and depletion of the brain's primary antioxidant,~     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While~     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some~     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement,~     obstacles surrounding currently employed delivery methods have hindered the clinical utility~     of this therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM~     therapy in patients with PD, and bypasses the obstacles associated with other delivery~     methods. It has been used in clinical practice since 2005. The aim of this study is to~     evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with~     PD in a Phase I single ascending dose escalation study.~   "
126580|NCT01398722|"~     The investigators sought to determine whether intensive insulin therapy can improve~     prognosis of infants undergoing cardiac surgery.~   "
126581|NCT01398709|"~     The purpose of this study is to investigate the relationship between rewarming rate during~     cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.~   "
126582|NCT01398696|"~     To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in~     primary care.~   "
126583|NCT01398683|"~     Comparison of epidural anesthesia and general anesthesia for laparoscopic cholecystectomy,~     patients in the surgery and the effectiveness of anesthesia after surgery, the incidence of~     side effects or complications, and postoperative recovery of the body of the differences~   "
126584|NCT01398670|"~     This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's~     Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and~     Humalog® Mix in patients with Type 1 Diabetes Mellitus~   "
126585|NCT01398657|"~     This is an open-label randomized clinical study comparing primary prostate cryoablation~     alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy~     (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.~   "
126586|NCT01398644|"~     Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in~     excessive iron overload. Phlebotomy is currently the standard therapy. More recently~     Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which~     potentially offers a more efficient method to remove iron overload with fewer procedures.In~     the proposed clinical trial the investigators will examine whether TE can keep the ferritin~     levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the~     number of treatment procedures when compared to current standard therapy by P.~   "
126587|NCT01398631|"~     Various elements of patient history are checked and entered in the admission Case Recor Form~     (CRF). Three risk scores are calculated out of these elements, combined with physical~     examination, laboratory values and ECG-findings.~      The primary aim is to assess the positive and negative predictive values for a~     cardiovascular event of the three risk scores for chest pain patients.~      Secondary aim is to assess the sensitivity and specificity of various elements in the~     patient history for an acute coronary syndrome.~   "
126588|NCT01398618|"~     Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in~     recent years. Further reduction in TB incidence, or even elimination should rely on~     treatment for LTBI. However, which is the cost-effective screening method or what is the~     cost-effective regimen in Taiwan is still unclear.~      Therefore, the investigators designed this prospective study to follow up adult household~     contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month~     rifampicin).~   "
126589|NCT01398605|"~     The study is designed to investigate the physical activity and its dose-response~     relationship in postmenopausal women on the cardiovascular risks and cardiac function.~   "
126590|NCT01398592|"~     This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG)~     lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after~     a two weeks treatment on top of metformin.~   "
126591|NCT01398579|"~     The investigators hypothesis that~        1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for~          diagnosing gastric preneoplastic and neoplastic lesions is acceptable~        2. pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher~          sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic~          lesions~   "
126737|NCT01396681|"~     This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy~     Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.~   "
126592|NCT01398566|"~     Today's hospitals need innovative solutions to help patients transition from our care to~     self-management at home. The vast majority of the patients seen in Dodd Rehabilitation~     Hospital and associated clinics leave our care with persistent and life-altering challenges~     - behavioral, cognitive, emotional and/or physical. The period of time immediately following~     discharge is an under-addressed stage within the continuum of care. The investigators are~     researching solutions to help patients in this transition to self-care and believe that~     multiplayer gaming paradigms may be a promising innovation to facilitate this transition.~      The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games~     like it, are promising novel interventions that could make a positive difference in the~     ability of our patients to successfully transition to self care after discharge from~     therapeutic care.~      Specifically, the investigators will evaluate feasibility of use of such a game by mild to~     moderate brain injured individuals and to record pilot data to help us plan a clinical~     effectiveness follow up study. Our goal is to finish this study with an intervention~     tailored for use within the clinical continuum of care and sufficient pilot data to prepare~     for a randomized clinical control trial of this intervention.~   "
126593|NCT01398553|"~     The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke~     patients. It neutralizes limb weight, enabling patients to use residual control in both arm~     and hand and to follow exercises guided by simulations of real-life challenges. The Armeo~     Spring incorporates wrist pronation and supination, allowing patients to enhance functional~     reaching patterns.~      Aim of the study is to compare the Armeo device with standard physiotherapy in chronic~     patients with acquired brain lesions.~      The result of the trial should show which treatment is more effective in the clinical~     practice. A significant better outcome of one arm should suggest to follow one treatment~     strategy more than the other.~   "
126594|NCT01398540|"~     The aim of this project is to investigate humoral and cellular immune responses before and~     after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 65 years~     of age.~   "
126595|NCT01398527|"~     The research question is, does a multifaceted, multidisciplinary intervention including~     small groups, chart audits and point of care tools, increase the number of people receiving~     optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include~     the number of falls and fractures experienced by the residents in each LTC home and the~     number of residents receiving appropriate bisphosphonate therapy.~   "
126596|NCT01398514|"~     The purpose of the study is to learn how differences in learning under mildly-stressful~     circumstances may be changed by taking an antidepressant medication. This medication is~     called Lexapro (Escitalopram). The investigators will also examine the impact of any~     anxiety, depression, and stress related symptoms on learning processes. The investigators~     will also look at the response of these symptoms to Lexapro.~   "
126597|NCT01398501|"~     Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for~     patients with AML with the FLT3-ITD mutation and information from these studies suggests~     that sorafenib may help to control leukemia. The purpose of this study is to find the~     highest dose of sorafenib for maintenance therapy that can be safely used in participants~     with AML who have undergone allogeneic stem cell transplant.~   "
126598|NCT01398488|"~     Experimental intervention:~      Patient education after lung transplantation via Tablet computers. An electronic patient~     questionnaire via tablet computer will be collected in addition.~      Control intervention:~      Conventional Patient education by health care professionals. A paper-based patient~     questionnaire will be provided.~   "
126599|NCT01398475|"~     The purpose of this trial is to assess the effect of three formulations on the relative~     bioavailability of LY3009104. Subjects will receive single dose of LY3009104 on 4 separate~     occasions with and without food. Safety evaluation and serial Pharmacokinetic (PK) samples~     will be collected during each treatment period. Approximately 5-7 days of washout period~     between each treatment and a follow-up visit will occur approximately 5 to 7 days after the~     last dose of study drug.~   "
126600|NCT01398462|"~     CWP232291 blocks proliferation of cancer cells via activation of caspases. Active caspase~     have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for~     degradation through caspase-directed cleavage. CWP232291 targets beta-catenin for~     degradation and thereby inhibits the expression of cell cycle and anti-apoptotic genes such~     as cyclin D1 and survivin.~   "
126601|NCT01398449|"~     Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer~     after esophagectomy and with pathological stage of T1-2,N+,M0?~   "
126602|NCT01398436|"~     The aim of the study is to compare oxygen saturation of blood samples collected from the~     superior vena cava, the right atrium, and the pulmonary artery. A secondary target was to~     assess whether positioning the tip of central venous catheters in the right atrium causes~     more arrhythmias than positioning it in the superior vena cava.~      The study is carried out in patients that undergo central venous and pulmonary artery~     catheterization for surgical coronary revascularization. In the interventional group~     (atrium, A), the tip of the central venous catheter (CVC) is placed in the right atrium; in~     the control group (control, C), the tip is placed in the superior vena cava. In both groups,~     CVC position is confirmed with transesophageal echocardiography (TEE). At fixed times during~     surgery and in the following 72 hours, heparinized blood samples are collected from the~     proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter (PC) and~     oxygen saturation is measured by an oximeter. Besides, mechanical and electrical~     complications potentially influenced by CVC position are registered.~        1. The primary aim of the study will be achieved by performing the following analysis on~          values from CVC proximal and distal lumens:~             1. a Bland Altman analysis between proximal and distal oxygen saturation in group A,~               in order to evaluate if the two measures are equivalent~             2. a comparison of the difference between proximal and distal oxygen saturation in~               groups A and C in order to rule out random errors~        2. In addition:~             1. differences in oxygen saturation between proximal or distal CVC and distal PC will~               be compared in order to evaluate whether distal saturation is more indicative of~               mixed venous saturation~             2. differences between proximal and distal oxygen saturation will be correlated with~               cardiac index and PCWP to investigate if low cardiac output and hypovolemia~               increase differences~        3. The secondary aim of the study will be achieved by comparing the incidence of cardiac~          arrhythmias in groups A and C~   "
126603|NCT01398423|"~     A randomized, double-blind, active control trial to determine the safety, efficacy and~     pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with~     hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.~   "
126604|NCT01398410|"~     The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or~     10 mg tablets administered once daily in participants who were confirmed to have no~     recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of~     treatment in the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of~     420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309~     (NCT01398410) study.~   "
126605|NCT01398397|"~     This study is being done to collect information about people who have or may have~     Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia~     (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that~     hopefully the investigators can develop a drug to treat this condition. In this study Edimer~     will retrospectively review and abstract (summarize) medical records of people that have or~     may have HED/XLHED in order to further understand the natural history and disease~     characteristics.~   "
126606|NCT01398384|"~     The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on~     Myocardial Infarction Size.~   "
126607|NCT01398371|"~     Heart failure is a chronic condition in which the heart fails to function as a pump to move~     blood around the body. This sets up a complex physiologic response to compensate, which~     include activation of many hormonal mechanisms which result in fluid accumulation.~      In recent years, medications to block the hormonal response to heart failure are given as~     standard drugs, and these include ACE inhibitors, and beta blockers. Mortality is reduced~     with these medications, as well as symptoms improved.~      Medications that were traditionally used in heart failure include diuretics, which cause~     fluid loss, and digoxin, which causes the heart to pump harder. These medications were~     introduced before clinical trials as we know them now were run. Since the introduction of~     ACE inhibitors and beta blockers, it is not clear whether there is still a role for digoxin.~      In this study, we plan to withdraw digoxin from patients with stable heart failure in normal~     rhythm, taking stable doses of ACE inhibitors and beta blockers, in a closely monitored~     environment and watch for the effect of this on heart failure.~   "
126608|NCT01398358|"~     The goal of this integrated project targeting the Childhood Obesity Prevention Challenge~     Area is to reduce the prevalence of obesity among children attending Head Start in Michigan.~     The proposed intervention program is based on Social Cognitive theory and the premise that~     enhancing children's capacity for emotional and behavioral self-regulation is a key~     component of effective obesity prevention. A randomized controlled trial design is proposed~     to evaluate, among 600 Head Start children and their parents, the effectiveness of 2~     approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS),~     a curriculum delivered to preschoolers and their parents focused on obesity-related health~     behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an~     evidence-based program designed to improve preschoolers' emotional and behavioral~     self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared~     to Usual Head Start exposure, will lead to greater improvements in obesity-related health~     behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements~     in obesity-related health behaviors and adiposity indices, and this effect will be mediated~     by improved self-regulation. The extension objective is to evaluate the feasibility,~     fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as~     delivered by paraprofessionals and educators within Extension and Head Start. The education~     objective is to provide Extension and Head Start staff non-formal training and educational~     curricula which can be widely disseminated. The long-term goal of this project is~     disseminate a novel and effective approach to obesity prevention in preschoolers.~   "
126609|NCT01398345|"~     Background~      —Pulmonary hypertension (PH) is associated with restricted physical capacity, limited~     quality of life, and a poor prognosis because of right heart failure. The present study is~     the first prospective randomized study to evaluate the effects of exercise and respiratory~     training in patients with severe symptomatic PH.~      Methods~      —Patients with PH on stable disease-targeted medication will be randomly assigned to a~     control and a primary training group. Medication will remain unchanged during the study~     period. Primary end points will be the changes from baseline to week 15 in the distance~     walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life~     questionnaire. Changes in WHO functional class, Borg scale, and parameters of~     echocardiography and gas exchange also will be assessed.~      Prospects~      —We hope this study will indicate that respiratory and physical training are a promising~     adjunct to medical treatment in severe PH.~   "
126610|NCT01398332|"~     This is an observational Registry designed to obtain early data on the use of the GORE®~     EXCLUDER® AAA Endoprosthesis with C3 Delivery System.~   "
126611|NCT01398319|"~     The prevalence of alcohol related incidents in technical training is too high. A brief group~     alcohol intervention was designed to reduce the number of alcohol related incidents in~     Technical Training.~      Hypotheses or Research Questions:~      Can a brief group alcohol intervention, focused on responsible use of alcohol during~     technical training reduce the prevalence of alcohol related incidents?~   "
126612|NCT01398306|"~     The primary objective of this study is to analyse the concentration dopamine and serotonin~     in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared~     to the concentrations of these catecholamines in healthy volunteers. The concentration~     dopamine and serotonin in thrombocytes with and without medication will also be evaluated.~   "
126613|NCT01398293|"~     This single-dose, randomized, double-blind, double-dummy, placebo-controlled,~     positive-controlled four-way crossover study will evaluate the effect of a single dose of~     danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects~     will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of~     danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D:~     placebo, with a washout period of at least 7 days between treatments.~   "
126614|NCT01398280|"~     The purpose of this study is to determine the effect of topical aminocaproic acid on the~     immune system by assessing the levels of antimicrobial peptides in the skin of patients with~     rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's~     immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.~   "
126615|NCT01398267|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     effect of aleglitazar on renal function, the renin-angiotensin system and the~     pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with~     lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be~     randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to~     lisinopril for 4 weeks.~   "
126738|NCT01396668|"~     This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed~     by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.~   "
126616|NCT01398254|"~     Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the~     treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is~     superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is~     superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a~     mortality benefit favouring TRA. The results of these two trials could significantly impact~     practice guidelines and lead to a recommendation that the approach of choice for primary PCI~     be radial rather than femoral. This would have significant implications for both PCI centers~     and interventionalists associated with a large impact on practice and education. Yet, many~     centers and interventionalists in Canada and in the USA prefer TFA and currently feel~     pressured in making the change to TRA. With that said, these trials did not include new~     pharmacotherapy and new technology that would likely have closed or eliminated the gap~     between TFA and TRA by improving the safety and efficacy of these two approaches.~     Furthermore, these trials were not powered to conclusively show a mortality benefit. The~     authors of the two large trials emphasized the need for further trials to confirm the~     benefits of TRA.~      The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary~     percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality~     measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite~     of death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial~     will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or~     unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be~     avoided. The study will encourage liberal use of vascular closing devices. The trial will~     also compare delays to reperfusion between the two strategies. Finally, a cost analysis is~     proposed.~      In view of recent publications, there is now a need for a large randomized trial using~     contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in~     PPCI. The proposed trial aims to conclusively show whether there is a survival benefit~     associated with the TRA approach.~   "
126617|NCT01398241|"~     This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate~     the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683~     in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo~     orally daily for 28 days. Follow-up will be 10 weeks after the last dose.~   "
126618|NCT01398228|"~     The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a~     significant component, has increased rapidly and substantially in China over recent years.~     Over the coming decades China is predicted to experience a 69% increase in acute coronary~     disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of~     more than 15,000 patients with acute coronary syndromes, the second phase of Clinical~     Pathway for acute coronary syndromes in China (CPACS-2) study, showed that a quality~     improvement initiative could improve aspects of hospital care, including the proportion of~     patients discharged on appropriate medication. The study also identified a number of~     barriers to improved care including out of pocket costs and administration systems. However,~     the study was not able to determine the impact on clinical outcomes or the~     cost-effectiveness of the intervention. The aim of the third phase of the Clinical Pathway~     for acute coronary syndromes in China (CPACS-3) study is to determine whether a complex~     intervention comprising a clinical pathway for ACS management in combination with a number~     of physician and patient-oriented education tools can improve the quality of care and health~     outcomes among ACS patient admitted to resource-limited (provincial) hospitals. The~     effectiveness of the intervention will be evaluated using a cluster randomized trial~     (stepped wedge design) of ACS patients admitted to 104 hospitals in China. The study will~     incorporate two additional components (1) a qualitative substudy to identify the barriers~     and enablers to improved care and (2) a study comparing the cost-effectiveness of the~     intervention compared to usual care, from the perspective of the health care provider. The~     study will be conducted in conjunction with the Chinese Ministry of Health and the Chinese~     Society of Cardiology. The findings from CPACS3 will be able to inform health policy-makers~     about the extent to which quality improvement initiatives can reduce the risk of death and~     disability among the millions of ACS patients admitted to hospitals in China each year.~   "
126619|NCT01398215|"~     This is a prospective chart review/data collection study of natural orifice translumenal~     endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires~     administered throughout the study. Subjects enrolled will be those intending to have a~     transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12~     months post-op.~   "
126620|NCT01398202|"~     The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is~     five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared~     to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week~     supplementation study during winter months.~   "
126621|NCT01398189|"~     To examine the feasibility of molecular imaging markers in clinical psychopharmacology~   "
126622|NCT01398176|"~     The purpose of this study is to determine whether consuming mushrooms is effective in~     enhancing the function of γδ T cells.~   "
126623|NCT01398163|"~     The purpose of this study is to evaluate the effect of a commercially available fermented~     dairy product containing probiotics (4 weeks, twice a day) on the brain activity within~     specific neural circuits regulating the subjective experience of emotional valence and~     digestive well-being.~   "
126624|NCT01398150|"~     The purpose of this study is to determine whether consuming a beverage made with cranberry~     polyphenols and proanthocyanidins is effective in modifying immune function by enhancing~     immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell~     proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.~   "
126625|NCT01398137|"~     This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue~     medication usage (as measured by Rescue Medication Score as a Combined Score to inform the~     design of a phase III field study with ToleroMune Ragweed.~   "
126626|NCT01398124|"~     Despite recent advances in the treatment of patients with resected NSCLC, disease recurrence~     and mortality related to lung cancer are common among patients with early stage non-small~     cell lung cancer (NSCLC). Therefore novel approaches are necessary to improve the outcome~     for early stage NSCLC. The preclinical studies conducted with vaccine based approaches~     provide the rationale to evaluate this as an adjunct to surgery for patients with early~     stage NSCLC. Administration of the vaccine before surgery will also allow for the evaluation~     of the tumor specimen for immunological responses to the vaccine.~   "
126627|NCT01398111|"~     This study will be carried out in healthy volunteers with the primary objective to evaluate~     the pharmacokinetic interaction between Glyco and Formoterol administered using a~     pressurised metered dose inhaler (pMDI).~   "
126628|NCT01398098|"~     Ultra-sound study to assess changes in intragastric volume after bowel preparation.~   "
126629|NCT01398085|"~     IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine~     ablation is necessary for low risk differentiated thyroid cancer patients.~   "
126646|NCT01397864|"~     This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients~     treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form~     (Ruconest), to observe adverse events and insufficient efficacy, and to assess the~     immunological profile following single and repeated treatment with Ruconest.~   "
126647|NCT01397851|"~     Preliminary evidence from ongoing research provides strong indications that protecting~     farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan~     Africa. The study team invests in experimental research to investigate this conjecture in~     more detail.~   "
126630|NCT01398072|"~     Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and~     exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK.~     Bacterial infections play an important role in the development of COPD, however, there is~     little information available about the use of long term antibiotics in the treatment of this~     disease. Therefore the purpose of this study is to identify the best antibiotic regime for~     treating patients with COPD who have persistent bacterial infection in their lung. We will~     test a variety of approaches including both older and newer regimes prescribed either on a~     daily basis at a lower dose or in pulsed courses (for example, every other day or five~     days every month). The three antibiotics tested in this study are: moxifloxacin,~     azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital,~     London. It is expected that approximately 200 patients will be selected for this study. The~     information we get from this study may help us to treat future patients with COPD better.~   "
126631|NCT01398059|"~     The purpose of this study is to determine whether acute bouts of sedentary behaviour (with~     or without breaks and/or structured physical activity) result in measurable changes in~     metabolic health in children and youth.~   "
126632|NCT01398046|"~     The goal of this study is to evaluate the ability of a natural supplement (betaine~     hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The~     investigators predict that betaine hydrochloride will increase the absorption of dasatinib,~     in volunteers pre-treated with proton-pump inhibitors (PPIs).~   "
126633|NCT01398033|"~     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience~     with stenoses or occlusions of the lower limb. To date only a small number of these patients~     could be helped through medication or surgery. The indications for stent placement are poor~     primary results following percutaneous transluminal angioplasty or evidence of a~     flow-limiting dissection. The primary success rate after a stent placement is between 80%~     and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis~     which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only~     percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis~     reoccurs in 70% to 80% of cases.~      The aim of this study is to analyse the primary success and the long term results of~     angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in~     the treatment of in-stent restenosis of lower limb arteries.~   "
126634|NCT01398020|"~     The investigators wish to compare the efficacy and patient tolerability of a preparation~     consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L~     Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show~     higher efficacy and tolerability.~   "
126635|NCT01398007|"~     Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as~     well as future behavior related to dental problems in children. A common cause of such~     anxiety and fear is the procedural intervention that uses needles and syringes since a~     visual impact due to the needle acts as a deterrent to the child's cooperation during dental~     procedures. We therefore improvised the syringe such that it will camouflage the needle. We~     hypothesized that the use of this needle will alleviate the child's anxiety and therefore~     will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group~     randomized trial to test the efficacy of the camouflage syringe as compared to the~     conventional syringe in children.~   "
126636|NCT01397994|"~     This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener,~     nicorandil in patients of chronic stable angina.~   "
126637|NCT01397981|"~     The purpose of this study is to determine how well people can be trained to produce new and~     different movements through the use of haptic feedback. One particular application is~     retraining individuals to walk differently in order to reduce knee joint loads to prevent or~     treat knee osteoarthritis as an alternative to surgical treatments.~   "
126638|NCT01397968|"~     This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when~     compared to baseline in subjects with partial onset seizures not fully controlled despite~     their treatment with 1 to 3 concomitant anti-epileptic drugs.~      Also to evaluate the safety and tolerability of YKP3089.~   "
126639|NCT01397955|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Julina for postmenopausal~     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina~     in clinical practice. A total 100 patients will be recruited and followed 3 years since~     starting Julina administration.~   "
126640|NCT01397942|"~     To investigate if a high dietary intake of bitter and strong tasting vegetables have~     positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting~     and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers,~     biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake~     of mild and sweet modern vegetables or a normal western diet.~   "
126641|NCT01397929|"~     First in human, open-label, sequential dose escalation and expansion study of intravenous~     BAL101553 in adult patients with advanced solid tumors.~   "
126642|NCT01397916|"~     The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia~     (CLL) is studied.~   "
126643|NCT01397903|"~     The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks,~     in patients with MDD who had an inadequate disease control with antidepressant medication.~   "
126644|NCT01397890|"~     This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV~     design to assess the efficacy and tolerability of Symbicort as an add-on treatment to~     Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary~     disease (COPD).~   "
126645|NCT01397877|"~     This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment~     of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.~      Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending~     on the group of patients. The primary endpoint is the non-progression rate at 3 months (12~     weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the~     non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive~     disease (high grade tumor = stratum 2).~      Disease progression is defined by the RECIST 1.1 criteria~   "
126649|NCT01397825|"~     This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib~     (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma~     (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The~     study has three parts as follows:~      Part 1, Phase 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab.~      Part 2, Phase 1: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab +~     Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma~     (including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2.~      Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or~     refractory DLBCL or TFL at recommended Phase 2 dose.~   "
126650|NCT01397812|"~     The purpose of this study is to demonstrate and validate a breath test for detection of~     biomarkers of heart transplant rejection (Grade 2R heart transplant).~   "
126651|NCT01397799|"~     This Phase 1b study will determine the maximum tolerated dose of KX2-391 given as a~     once-daily dose, in elderly patients with acute myelogenous leukemia.~   "
126652|NCT01397786|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     oral OPC-34712 as monotherapy in adults with schizophrenia.~   "
126653|NCT01397773|"~     The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis,~     peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with~     the control group; so as to investigate the eligibility of it as a reliable marker of~     inflammation; relationship with other inflammatory markers and carotis intima media~     thickness.~   "
126654|NCT01397760|"~     The purpose of this study is do describe the experience in the use of omalizumabe, in a real~     life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient~     clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed~     will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations,~     emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma~     medication).~   "
126655|NCT01397747|"~     The primary objective is to determine the sensitivity and specificity of the Exact~     Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the~     reference method. Lesions will be confirmed as malignant by histopathologic examination.~      The secondary objective is to compare the performance of the Exact CRC screening test to a~     commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions~     will be confirmed as malignant or precancerous by colonoscopy and histopathologic~     examination.~   "
126656|NCT01397734|"~     In this research study, the investigators are looking to see whether the combination of~     arsenic trioxide with a tyrosine kinase inhibitor is safe, and what effects it has on~     chronic myelogenous leukemia.~   "
126657|NCT01397721|"~     The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease~     (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early~     COPD using imaging, gene expression profiling and peripheral cellular measures.~   "
126658|NCT01397708|"~     This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in~     combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a~     protein that may improve the body's natural response to disease by enhancing the ability of~     the immune system to kill tumor cells and may interfere with blood flow to the tumor.~      The main purpose of this study is to evaluate the safety and tolerability of tumor~     injections of INXN-2001 given in combination with different doses of INXN-1001.~   "
126659|NCT01397695|"~     Terence M. Davidson, MD is conducting a research study to find out more about the topical~     application of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis~     (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).~   "
126660|NCT01397682|"~     The goal of this research study is to collect clinical data, comprehensive geriatric~     assessment, risk factors, biological data and blood samples from inpatients aged 65 and~     older at the INRCA research hospitals (Italy). All data will be stored in a research bank~     and used to better clarify the mechanisms underlying the condition of frailty in aged~     patients. The database will be created on the INRCA server platform by establishing a safe~     HTTPS protocol.~   "
126661|NCT01397669|"~     To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and~     non-acute HIV-infected adults~        1. To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in~          HIV negative and in non-acute HIV-infected subjects~        2. To compare the immunophenotyping of the peripheral blood in HIV negative and non-acute~          HIV-infected adults to the findings from acutely HIV-infected subjects in the~          WRAIR#1494/RV254/ SEARCH 010 study~        3. To compare immunologic markers in the genital compartment compared to the peripheral~          blood in HIV negative and non-acute HIV-infected adults to the findings from acutely~          HIV-infected subjects in the WRAIR#1494/RV254/ SEARCH 010 study~        4. Archive samples for immunologic and virologic testing~   "
126662|NCT01397656|"~     STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR~     quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest~     compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater.~      More specifically, the investigators will compare each CPR ratio with regard to:~        1. The achieved frequency and depth of chest compressions, and~        2. Participant rating of their perceived level of exertion.~      STUDY HYPOTHESIS~      In a population aged 55 or greater, the new CPR recommendations will lead to:~        1. less frequent and shallower chest compressions over the 5-minute study period; and~        2. higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.~   "
126686|NCT01397344|"~     Doctors' attire has known to impact patients' trust and confidence for better clinical~     practice. However, few survey research regarding this topic has been conducted in~     traditional asian medicine field. The aim of our study is to determine whether traditional~     medicine doctor's attire impacts on patients' confidence and trust.~      Participants will be given randomly one set of photographs from the 2 kind of photographs,~     i.e., photographs of a male or female doctor, each set dressed in 4 different styles.~      After this, they will be asked to report their preferences for the 4 styles of dress~     according to given questions and they will answer the degree of their feeling on the~     importance of Korean Medicine doctor's appearance.~   "
126663|NCT01397643|"~     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon~     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence~     regarding the optimal treatment and outcome of these fractures within the elderly population~     with one case series in the literature describing 13 patients. Our trial includes all~     patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic~     Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial~     will be randomised to operative fixation using one of two treatment methods. Patients in the~     nonoperative group will be place in a sling for two weeks and then allowed to mobilise under~     supervised physiotherapy as per normal protocol. For those patients in the operative group,~     tension band wire of plate fixation will be employed depending on the choice of their~     supervising consultant. Patients will be evaluated over a one year period following their~     treatment.~   "
126664|NCT01397630|"~     The ultimate objective is to test the hypothesis that an 'accelerated titration' protocol~     for labour augmentation with oxytocin reduces the risk of caesarean births relative to a~     'gradual titration' protocol.~      The aims of this pilot feasibility are:~        1. To assess the feasibility of a large multi-centre randomized control trial comparing~          the two above oxytocin protocols (accelerated titration versus gradual titration for~          correction of dystocia).~        2. More specifically, to identify potential challenges in the study implementation,~          particularly with respect to patient recruitment, randomization, blinding, and~          compliance/adherence to the labour management guidelines and study protocols.~        3. To obtain preliminary data on the acceptability of the accelerated oxytocin titration~          protocol among obstetrical providers and participants.~   "
126665|NCT01397617|"~     The purpose of this study is to determine the survival rate, marginal bone resorption, soft~     tissue health and maintenance of the NobelActive Internal and External implants and to make~     comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.~   "
126666|NCT01397604|"~     The advent of vaccines contributed to major improvements in human morbidity and mortality~     due to infectious diseases such as polio, small pox, measles and diphtheria. However~     infectious diseases like HIV, malaria and tuberculosis continue to be major causes of death~     worldwide and conventional vaccine strategies have not been successful. The fundamental~     problem is that current protein based vaccines do not elicit the necessary T-cell immunity.~     Experimentally, adjuvants can be given in conjunction with a vaccine to activate and mature~     the dendritic cell (DC), which can then direct an immune response to enhance T-cell~     immunity. One family of potential adjuvants functions through the activation of Toll-like~     receptors (TLR) on the DC. Major gaps exist in our understanding of adjuvant effects in~     humans. We hypothesize that a synthetic adjuvant directed to activate TLR4 (GLA) will safely~     stimulate the innate immune system when administered subcutaneously (SC) or intramuscularly~     (IM). Importantly, in contrast to other adjuvant trials in which adjuvant is combined with~     an antigen or vaccine, GLA will be tested in isolation. This is because we anticipate the~     future administration of GLA with our dendritic cell targeted HIV vaccine. A DC-targeted~     vaccine cannot be given without an immune stimulating adjuvant due to potential risk of~     inducing immune tolerance. Therefore, in order to understand the specific contributions of~     GLA versus the DC-targeted vaccine, we need to understand the GLA effects in isolation. The~     safety and tolerability of 2 different formulations of GLA (GLA-SE vs. GLA-AF) administered~     by 3 different routes (SC, ID, IM) will be the major focus of this trial. The second focus~     will be characterizing the innate immune response by assessing systemic cytokine and~     chemokine levels and determining global gene regulation following GLA stimulation. The third~     focus will be on the cellular effects of GLA, specifically on blood monocytes and dendritic~     cells. Monocytes may represent a large pool of inducible potent DC (monocyte-derived DC),~     however these cells have not been well characterized in humans. We will investigate the~     effects of GLA stimulation on the peripheral blood monocyte subsets that might give rise to~     monocyte-derived DC.~   "
126667|NCT01397591|"~     This phase II trial studies how well giving ofatumumab together with bortezomib works in~     treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma~     (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block~     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.~     Others find cancer cells and help kill them or carry cancer-killing substances to them.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells~   "
126668|NCT01397578|"~     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET~     imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.~   "
126669|NCT01397565|"~     Laparoscopic cholecystectomy is one of the most commonly performed operations in general~     surgery and is considered the standard of care for cholecystectomy for benign biliary~     disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is~     associated with less postoperative pain, quicker recovery time and an improved cosmetic~     result.~      Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the~     umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of~     two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to~     as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars~     with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further~     reduce postoperative pain and recovery time as well as improve cosmetic results following~     laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing~     conventional to minilaparoscopic cholecystectomy.~   "
126670|NCT01397552|"~     Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will~     be conducted on subjects that have not had previous injections or have not had an injection~     in the last 12 months. Subjects must be receiving one level injection and not had prior~     surgery at that level.~   "
126671|NCT01397539|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to~     moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study~     population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of~     BIIB037 after single-dose administration.~   "
126672|NCT01397526|"~     Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and~     hypothermia in children. The oedema formation is due to increased fluid transport from blood~     to tissue. This transcapillary fluid transport is dependent on differences in interstitial~     and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate~     changes in interstitial colloid osmotic pressure before, under and after the use of~     cardiopulmonary bypass in children. The study hypothesis is that oedema developed during~     cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage~     and reduced colloid osmotic pressure gradient through the capillary membrane.~   "
126673|NCT01397513|"~     The fibrin network is an important component of an arterial thrombus and its structure~     influences the degradation of the formed clot. A tighter and less permeable fibrin network,~     which is less susceptible to fibrinolysis, is formed in patients with manifest~     cardiovascular disease (CVD) or conditions associated with increased risk of~     atherothrombotic complications. In a previous study we have shown reduced fibrin network~     permeability in patients with type 1 diabetes, which may contribute to their increased risk~     of CVD. Low dose aspirin treatment is standard in management of CVD; however, the effect~     seems reduced in patients with diabetes. Our previous studies have shown that aspirin~     treatment alters the fibrin network in non-diabetic individuals and increases the fibrin~     network permeability. The effect of aspirin on fibrin network formation in patients with~     diabetes is unclear.~      We hypothesized that patients with type 1 diabetes might need higher doses of aspirin than~     the recommended low dose (75mg) treatment to gain effects on fibrin network permeability,~     and that the effects of aspirin treatment on fibrin network in these patients are influenced~     by the glycemic control.~   "
126674|NCT01397500|"~     Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury,~     ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on~     cognition, quality of life and body composition Randomized, controlled, 3 arm (group 2:~     double-blind; groups 1 and 3: open), multi-center, pilot study (Phase II)~   "
126675|NCT01397487|"~     The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and~     implantation rate.~   "
126676|NCT01397474|"~     -  Impaired peripheral perfusion is related to worse outcome in critically ill patients.~          Although this is known, these parameters have never been used as target for hemodynamic~          therapy.~        -  We hypothesize that targeting of fluid administration on parameters of peripheral~          perfusion might prevent excessive fluid administration, leading to less formation of~          tissue edema, less respiratory dysfunction and shorter duration of mechanical~          ventilation in critically ill patients.~   "
126677|NCT01397461|"~     This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for~     ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo~     comparison), superiority clinical study comparing ozenoxacin cream versus placebo and~     retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or~     bullous impetigo.~   "
126678|NCT01397448|"~     The primary objective of this study to evaluate the effect of preventing recurrence of~     gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or~     Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose~     aspirin and thereby examine the superiority of E3810 over Teprenone.~   "
126679|NCT01397435|"~     The bone status in Gaucher disease is very difficult to monitor precisely in children. This~     is a major problem because lack of optimal treatment, especially enzyme replacement, may~     cause irreversible severe bone damage that will impact an affected person's life. Currently,~     there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to~     gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell~     presence and activity in bone marrow could help with more precise and accurate monitoring of~     bone marrow disease in patients both treated and not (yet) being treated with enzyme~     replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy~     (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and~     examine how this result correlates with semiquantitative MRI scales and overall disease~     severity.~   "
126680|NCT01397422|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group~     study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102~     oral capsules, an extended release formulation of amantadine, dosed once daily for the~     treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).~     The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine~     plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor~     symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight,~     which may reduce the sleep disturbances and vivid dreams occasionally associated with~     amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is~     expected to improve overall tolerability of amantadine.~   "
126681|NCT01397409|"~     This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of~     the safety of AGN-150998 administered as a single intravitreal injection to patients with~     advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are~     randomized, double-masked, comparisons of the safety and treatment effects on retinal edema~     and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive~     patients with exudative AMD. Study medication is administered as needed in Stage 2 and with~     a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest~     tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on~     retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of~     AGN-150998.~   "
126682|NCT01397396|"~     The additional effect of inspiratory muscle training as an adjunct to a general exercise~     training program in patients with COPD with inspiratory muscle weakness will be studied. The~     main hypothesis is that inspiratory muscle training combined with an exercise training~     program improves functional exercise capacity more than an exercise training program without~     the addition of an inspiratory muscle training program.~   "
126683|NCT01397383|"~     The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on~     post-operative short-term functional outcomes after total hip arthroplasty (THA).~      Hypothesis: Patients with low serum vitamin D level will have less within-patient~     improvement in pre- to 6 week, 1 year, 2 year and 5 year post THA WOMAC scores, SF-36~     scores, and performance-based tests(get up and go test and 2 minute walking test) compared~     to patients who do not have a low vitamin D levels.~      Also, Patients with low serum vitamin D level will have a higher rate of postoperative thigh~     pain or periprosthetic fracture.~   "
126684|NCT01397370|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and~     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple~     oral administrations.~   "
126687|NCT01397331|"~     The aim of the study is to delineate and compare the changes in coupled mechanical~     properties of left ventricle and arterial vascular bed caused by two popular anesthetic~     protocols commonly used in cardiac surgery (intravenous, based on the infusion of propofol,~     versus inhalational, based on isoflurane) on different stages of the surgery.~   "
126688|NCT01397318|"~     Many pregnant women experience stress, fatigue, and poor sleep quality that may influence~     infant outcomes such as prematurity and low birthweight through immunologic pathway of~     biomarkers (serum cytokines and c-reactive protein). In contrast, TaiChi exercise, one kind~     of physical activity, can increase pulmonary and immune functions and reduce stress may~     therefore prevent pregnancy complications and further prevent adverse pregnancy outcomes;~     however, its effects has not been explored in studies. Therefore, this study aims to~     investigate relationships between prenatal stress, fatigue, sleep quality, biomarkers, and~     infant outcomes; modified a TaiChi exercise program suitable for pregnant women; and test~     the effects of the exercise on reducing stress and fatigue, promote sleep quality, modulate~     biomarkers, and prevent adverse infant outcomes. Infant outcomes in the study will be~     measured with gestational age and birthweight. The study is a three-stage longitudinal~     interventional design.~   "
126689|NCT01397305|"~     The purpose of this study is to determine whether an optimal dose of [6R]~     5,10-methylenetetrahydrofolate (Modufolin) in combination with pemetrexed are effective in~     pre-operative treatment of patients with resectable rectal cancer.~   "
126690|NCT01397292|"~     The purpose of this research study is to examine the safety, tolerability, and effectiveness~     of currently available pulmonary procedures when used to diagnose or treat different~     diseases.~      This study will collect information that may influence the outcome of the procedure and~     identify factors that may affect the procedures yield or safety. The information will be~     entered into a registry or data storage.~   "
126691|NCT01397279|"~     Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin~     resistance of the liver is an altered hepatic glucose metabolism. This study investigates~     whether the whole body (M-value) and hepatic insulin sensitivity obtained by~     hyperinsulinemic euglycemic clamp is influenced by a preceding intravenous glucose tolerance~     test (Botnia Clamp) in subjects with type 2 diabetes.~   "
126692|NCT01397266|"~     In a randomized, double-blind controlled trial the investigators will evaluate the efficacy~     of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative~     analysis - such behavior and possible behavioral consequences related.~   "
126693|NCT01397253|"~     Communication between physicians caring for a patient in the hospital and that patient's~     primary care provider is less than optimal, and can lead to diminished health care quality~     and safety. This project will lead to better communication between physicians and could~     decrease medication errors that tend to occur as the patient goes from hospital to home.~   "
126694|NCT01397240|"~     The purpose of this study is to research the safety and efficacy of Albis® for the~     prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.~   "
126695|NCT01397227|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of two~     dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad)~     Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of~     the protective efficacy of the higher dose level in an experimental malaria challenge.~      The study will be in 3 phases:~        1. a dose escalation / vaccination phase in which both dose levels will be tested~        2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01~          5x10^10 vp dose level, together with six infectivity control subjects, will be exposed~          to experimental challenge with Plasmodium falciparum~        3. a long term follow up phase in which all subjects who received active vaccine from both~          dose levels and/or malaria challenge will be included~   "
126696|NCT01397214|"~     Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety~     compared to Megace OS.~      Phase I study divided into 3 parts written as belows.~      Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs~     Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers~   "
126697|NCT01397201|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses~     twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA~     MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in~     asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled~     corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second~     (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at~     time of randomisation~   "
126698|NCT01397188|"~     PiCCO has become a widely used haemodynamic monitoring device in the management of shock~     patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as~     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical~     ventilation-free days and change of lactate and BNP in shock patients has not been~     determined. Patients will be randomly assigned to a Picco group or the control group,~     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical~     ventilation-free days and change of lactate and BNP will be observed. The conclusion will~     supply evidence for the clinical effectiveness of Picco in shock patients.~   "
126699|NCT01397175|"~     The primary objective of this study is to compare the rate of device-oriented composite~     consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget~     vessel, and clinically indicated target lesion revascularization among the patients treated~     with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end~     points are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is~     equivalent to ZES-R at the primary end point.~   "
126700|NCT01397162|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses~     twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA~     MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in~     asthmatic patients aged 12 to 65 years inadequately controlled on short-acting-beta-agonist~     (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one~     second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater~     than 1.5 at time of randomization~   "
126703|NCT01397123|"~     The purpose of this study is to assess the effects of a six months nutrition intervention,~     delivered and taught by classroom teachers with in-service nutrition training, on the~     prevention of overweight and obesity among children in grades 1 to 4.~      In this randomized controlled trial, 464 children from seven elementary schools were~     allocated to a six months nutrition educational intervention by their own teachers or to~     standard care. Intervened teachers had 12 sessions of three hours each with the researchers~     throughout six months, according to the following topics: nutrition and healthy eating~     (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage~     fruits and vegetables consumption and to decrease high energy-density foods intake (sessions~     6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking~     activities (sessions 11 and 12). After each session, teachers were encouraged to develop~     activities in class that focused on the learned topics. Sociodemographic, anthropometric,~     dietary, and physical activity assessments were performed at baseline and the end of~     intervention.~      We expect that fewer intervened children become overweight and the consumption of fruit and~     vegetables will be higher. In addition, we expect a less consumption of low-nutrition high~     dense foods.~      We also expect to provide further support to decrease overweight epidemic, involving~     classroom teachers in a training intervention and making them dedicated interventionists.~   "
126704|NCT01397110|"~     The purpose of this study is to investigate the influence of physical training on exercise~     capacity, quality of life, functional class, oxygen consumption and right ventricular~     function in patients with severe associated pulmonary arterial hypertension (APAH) as part~     of a congenital heart defect with / without Eisenmenger's Syndrome~   "
126705|NCT01397097|"~     The primary objective is to demonstrate that discontinuation rates in women (ages 18-35~     years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal~     implant over a period of 12 months.~      Secondary objectives are to observe the bleeding patterns, adverse event profiles and the~     occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS~     expulsions and implant site complications will be collected.~   "
126706|NCT01397084|"~     Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving~     rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant~     improvement of heartburn after 8-week treatment.~   "
126707|NCT01397071|"~     Avocados are naturally rich in antioxidants, or beneficial compounds, that can help prevent~     many diseases, like atherosclerosis (hardening of the arteries). When foods that are high in~     fats are eaten, certain harmful compounds can be absorbed, which can lead to~     atherosclerosis. One harmful compound is called malondialdehyde, or MDA. This compound can~     be measured in the blood and the urine after a person eats a high fat meal. Antioxidants~     found in herbs and spices may lower the absorption of MDA, which could help prevent the~     development of atherosclerosis.~      This study will determine whether the beneficial compounds of avocado can reduce absorption~     of MDA. This will be tested by asking healthy males to eat a high fat ground beef patty with~     or without avocado and then measuring the amount of MDA in their blood and urine samples.~     Blood flow will also be measured. Healthy men have been chosen for this study because eating~     high fat hamburger patties can easily mimic in them the condition that causes~     atherosclerosis. Avocadoes are rich in antioxidiants, which have been shown in previous~     studies to reduce the absorption of harmful compounds, like MDA, that are formed during~     cooking. The results from this study may help to explain how high fat foods can be harmful~     to the body and how beneficial antioxidants from herbs and spices can protect the body.~      This will be determined from blood and urine samples after the subjects are given two~     different meals: a) a plain cooked ground beef patty, and b) or avocado with a cooked ground~     beef patty.~   "
126708|NCT01397058|"~     Background. Human herpes viruses establish lifelong latency after primary infection and may~     reactivate in immunosuppressed patients causing significant morbidity and mortality. In~     immunocompetent patients, although reactivation may occur disease development is deterred by~     the competent host immune response. Recent studies indicate that approximately one third of~     CMV seropositive immunocompetent ICU patients present with CMV reactivation associated with~     poor outcome, potentially secondary to the stress incurred. CMV reactivation among~     immunocompetent critically ill children has not been assessed.~      Study Hypothesis: Identifiable risk factors associated with CMV reactivation exist and may~     be used for future assessment of antiviral prophylaxis administration.~      Aim: Primary aim is to identify risk factors associated with CMV reactivation and poor~     outcome in immunocompetent children and adults under severe stress. Whether CMV reactivation~     occurs in critically ill children and its clinical implications remains to be determined.~     Secondary aim is to study the role of cellular signaling pathways of inflammation and~     specific adaptive immunity during this process.~      Work packages: A multicenter observational prospective study will be conducted among CMV~     seropositive pediatric and adult ICU patients. Patient clinical progress, laboratory~     findings, management, and complications will be recorded during the 28 days following ICU~     admission. Salivary free cortisol levels, plasma catecholamines, and serum cytokines levels~     will be measured to assess stress. CMV reactivation will be evaluated weekly by detecting~     CMV-DNA in peripheral blood and bronchial wash samples with real-time PCR. In a patient~     subsample, the nuclear factor κB and intracellular GC receptor will be measured in~     peripheral blood monocytes to study cellular signaling pathways of inflammation. The~     adaptive immune response to CMV infection following in vitro viral polypeptide stimulation~     will be prospectively examined in a subset of patients.~      Expected Results: The study will provide original data on critically ill children. Further~     knowledge regarding risk factors associated with CMV reactivation and poor outcome will be~     accumulated. Novel information regarding the role of cellular inflammation and specific~     adaptive immune responses during CMV reactivation will be gathered.~   "
126709|NCT01397045|"~     Aim of this prospective randomized study is to assess the safety and efficacy of~     video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy~     (group A) during diagnostic process for pulmonary nodules.~   "
126710|NCT01397032|"~     Children with social anxiety will be randomly assigned to either Attention Bias Modification~     Treatment (ABMT) designed to direct attention away from threat or a placebo control~     condition not designed to change attention patterns. Outcome measures will be depression and~     social anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of~     social phobia disorder and symptom counts derived from structured clinical interviews with~     children and their parents.~      We expect to see significant reduction in social anxiety symptoms in the Attention Bias~     Modification Treatment (ABMT) group relative to the placebo control group.~   "
126711|NCT01397019|"~     Treating patients with initial local non-resectable pancreatic cancer with a combination of~     oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in~     potentially resectable patients, will result in a high rate of tumor shrinkage allowing~     subsequent resection in patients with initial borderline resectable tumors and improved~     overall survival for all patients.~   "
126788|NCT01396005|"~     In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will~     be given boceprevir. Blood samples will be taken at specified intervals to find out whether~     boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.~   "
126712|NCT01397006|"~     The purpose of the study is to evaluate whether pregabalin is effective in treating subjects~     who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA~     for treatment of fibromyalgia. the purpose of the study is to see if subjects identified~     through their primary care physicians who have fibromyalgia and have had symptoms for less~     than one year respond to pregabalin and to identify characteristics of that response.~   "
126713|NCT01396993|"~     Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast~     cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are~     sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic~     surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has~     been demonstrated by several authors using restrospective analyses. However, no prospective~     observational trial has been done to objectively evaluate cosmetic and oncologic outcome~     comparing BCT with iTOP. The aim of this study is to investigate this issue within a~     prospective non randomized observational trial at the Medical University Vienna.~   "
126714|NCT01396980|"~     -  SDF is validated by measuring changes in microcirculation in sepsis patients with MOF~          (Boerma studies).~        -  SDF is validated by measuring changes in microcirculation in stable chronic~          hemodialysis patients (NDT 2009 Bemelmans).~        -  Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual~          microcirculatory flow (NDT 2009 Bemelmans).~        -  Trendelenburg position improves the sublingual microcirculatory flow at the end of~          hemodialysis treatment (NDT 2009 Bemelmans).~        -  Hemodialysis with ultrafiltration leads to a significant reduction of myocardial~          perfusion and cardiac output (NDT 2009 Dasselaar)~        -  Cardiac output measurement during dialysis is not practical.~        -  BVM is a validated method for hypotension due to ultrafiltration to prevent the amount~          of ultrafiltration online change based on the measured haemoconcentration (ref~          Dasselaar et al NDT 2005).~        -  BCM is a validated measurement to the dry weight in hemodialysis patients measured by a~          bioimpedance technique (NDT Passauer et al 2009).~   "
126715|NCT01396967|"~     During cataract operations a capsulorhexis is being performed. This is done in order to~     enable the removal of lens material while keeping the capsule intact in order to put inside~     the lens capsule an artificial intra ocular lens.~      The capsulorhexis must be round and with regular edge and no tears. While performing a~     cataract surgery we use phako emulsification machine that sends an ultrasonic wave that~     creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and~     sucks the fluid and the lens material of the creaked lens.~      The round shape and the regularity of the capsulorhexis are a must in these surgeries since~     the lens capsule must stay intact and stable in order to enable the phacoemulsification and~     the implant of the artificial lens.~      Today capsulorhexis are done with a bent needle or with special forceps; the act of~     capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve~     is relatively long and difficult.~      The proposed device enables a capsulorhexis which is round and has regular edges, done~     almost automatically and is predicted. The learning curve is short and easy. The~     capsulorhexis is done through the original operating wound with no need to widen it.~   "
126716|NCT01396954|"~     Glucose metabolism disorders (GMD) can be present in an overt and a subclinical way. They~     have negative impact in survival of patients with liver cirrhosis (LC). Their prevalence has~     not been determined in compensated cirrhotic patients.~   "
126717|NCT01396941|"~     This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in~     comparison to normal sleep, will:~        1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the~          hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.~        2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of~          endogenous glucose production, gluconeogenesis and glycogenolysis.~   "
126718|NCT01396928|"~     The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is~     able to improve functional results and quality of life after coloanal anastomosis.~   "
126719|NCT01396915|"~     This study is designed to assess the effect of a diet-controlled nutrition program utilizing~     an egg-based higher protein diet on muscle composition and size, and indices of metabolic~     health and markers of systemic inflammation in older men and women who are slightly~     overweight.~   "
126720|NCT01396902|"~     As a participant in these research program you will be a parent of a child born at Wesley~     Medical Center who plan to use Carriage Park Pediatric Clinic for your child's care. Mobile~     phone text messages will be sent to remind you of your child's immunizations.~      The long term research goal is to increase childhood immunization rates by improving~     parental health literacy through an innovative text messaging system regarding immunization~     schedules for children under the age of six.~   "
126721|NCT01396889|"~     Acute upper respiratory tract infections are the most commmon infections in children and are~     associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea~     is widely used for treatment of upper respiratoty tract infections. The aim of this study is~     to evaluate its efficacy as prophilaxis in children 1-5 years old.~   "
126722|NCT01396876|"~     The investigators hypothesized that the participation of therapeutic clowns in the pediatric~     emergency department procedure room would reduce anxiety, improve the level of cooperation~     children can provide and avoid some of the adverse effects.~   "
126723|NCT01396863|"~     The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration~     (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.~      The study consist of two examination days placed one week apart. 12 HD patients will be~     recruited to the study. The patients will be randomly placed in two groups: Pre-dilution~     hemodiafiltration during the first examination and low flux hemodialysis during the second~     day or vice versa.~      Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments.~     The MRI-data will later be processed to estimate brain volume changes during the two types~     of treatment.~   "
126739|NCT01396655|"~     Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy~     differ from those of early breast cancer.~      The purpose of this study was to identify the clinical significance of potential predictive~     and prognostic factors including serial FDG PET/CT in breast cancer patients treated by~     neoadjuvant chemotherapy.~   "
126724|NCT01396850|"~     BBB dysfunction has been indicated in some groups of schizophrenia patients by measuring~     increased albumin and immunoglobulin (IgG) cerebrospinal fluid (CSF) levels. Most of the~     authors described a raised protein level in 5-20% of the schizophrenic patients (Muller &~     Ackenheil, 1995). Increased S100B levels were demonstrated in the serum of patients~     suffering from schizophrenia as well as depression, and this may reflect increased BBB~     permeability. Furthermore, this increase remains in those patients who develop a residual~     state with relevant negative symptoms, whereas S100B levels normalize in recovering patients~     (Shalev, Serlin & Friedman, 2009). CSF albumin and CSF IgG values correlate significantly~     with some of the SANS (Scale for the Assessment of Negative Symptoms) subscales and the SANS~     total score, this shows the correlation between BBB permeability and behavioral changes. It~     is important to say that although negative symptoms are often signs of chronicity of the~     disease, the abnormal CSF findings in Muller's experiment (1995) are not related to the~     duration of the disease, because the patients were quite young and the duration of the~     disease was less than 3 years.~      The investigators hypothesize that a primary vascular pathology, which leads to BBB~     breakdown, will result a leakage of serum-derived vascular components in to the brain tissue~     and may cause brain dysfunction such as disturbed thinking processes, mood and behavior, as~     we can see in psychiatric patients.~   "
126725|NCT01396837|"~     The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in~     patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.~   "
126726|NCT01396824|"~     The purpose of this study is to determine whether nutritional status or body composition~     influences the prognosis of heart failure patients.~   "
126727|NCT01396811|"~     The purpose of this study is to determine if a topical antifungal cream is safe and~     effective for the treatment of tinea pedis.~   "
126728|NCT01396798|"~     Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely~     Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through~     prospective observational data collection concerning specific items from the clinical and~     technical examination in diagnosing serious infections, such as meningitis, sepsis,~     pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to~     validate a vital signs and symptoms rule derived from multiple low to high prevalent~     settings of acutely ill children.~   "
126729|NCT01396785|"~     The purpose of this study is to determine if a topical antifungal cream is safe and~     effective for the treatment of tinea pedis.~   "
126730|NCT01396772|"~     The purpose of this study is to determine if a 6-month community-based prediabetes lifestyle~     and behaviour change intervention (called, PREPARE) for middle and older adults with~     prediabetes will result in positive lifestyle behaviour change.~   "
126731|NCT01396759|"~     Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted~     to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1).~     Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the~     number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP~     is most frequently delivered to neonates using conventional mechanical ventilators, and thus~     there is minimal or no cost saving. There are other ways of delivering CPAP, such as~     Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an~     air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a~     bottle of water and the level of CPAP delivered is equivalent to the length of the~     expiratory tubing that remains under water. Robust equipment is now available at a fraction~     of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the~     mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk~     of complications, and has been proposed as an inexpensive method of delivering CPAP in~     developing countries (3).~      High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4);~     however, there is a lack of randomized studies comparing it with bubble CPAP or with~     standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2~     litre per kg per minute of blended air/oxygen mix, usually with a low fraction of inspired~     oxygen (say 25-40%). It is easy to apply, but requires additional equipment to standard~     oxygen therapy, and closer monitoring. High flow delivers uncertain levels of CPAP, so it~     is not clearly superior to bubble-CPAP, and there have been no controlled comparative trials~     of these two techniques.~      Pneumonia and malnutrition are two of the most common co-morbidities in children in~     developing countries (5). In hospitals in resource-poor settings, children with severe~     malnutrition and pneumonia often present with respiratory distress with or without severe~     hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation~     through nasal prong or face mask. Support from bubble CPAP might help to effectively treat~     hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its~     complications, and reduce mortality.~      Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of~     ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with~     pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ,~     MMed thesis, unpublished data). They often need mechanical ventilation, with attendant~     costs, complications and high mortality rates. However, no published data are available~     about the use of bubble-CPAP in children with pneumonia and malnutrition and there have been~     no controlled trials of CPAP in developing countries.~      The Hypothesis is:~      In children with severe pneumonia and hypoxaemia the probability of treatment failure (see~     definition below) will be significantly lower when respiratory support is initially provided~     by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard~     oxygen flow.~   "
126732|NCT01396746|"~     The purpose of this study is to explore the relationship between cardiovascular function of~     persons with post stroke conditions and their performance in three field tests. This is a~     validation study, aiming to determine during which of two activities VO2 measurements better~     express the functional restrictions caused by stroke, And to find out whether the Total~     Heart Beat Index can be used in the case of stroke survivors for the prediction of~     mechanical efficiency when measured during stair-climbing and of energy cost during~     treadmill walking.~      The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity~     testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of~     external work, and therefore will show stronger correlation with functional tests~     demonstrating the same ability, whereas TMW does not utilize the movement capability of~     participants to the fullest.~      Another hypothesis is that cardiac response to the exertion can be used as a predictor of~     those measures during these exertions in the post stroke population.~   "
126733|NCT01396733|"~     Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid~     carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which~     decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to~     improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate~     the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or~     metastatic of DTC with defective I-131 uptake.~   "
126734|NCT01396720|"~     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute~     coronary events and coronary interventions. Several studies have shown that some patients~     are resistant to clopidogrel. The resistance mechanism is not entirely clear, but at least~     in part it is related to interactions between medications. Clopidogrel is a pro-drug~     converted in vivo to its active metabolite by CYP2C19 and CYP3A in the liver. Consequently~     drugs that inhibit the CYP2C19 can affect the production of the active metabolite and cause~     clopidogrel resistance. Therefore the FDA has recently published a safety alert which~     recommends avoiding cross treatment with clopidogrel and drugs that are expected to inhibit~     CYP2C19 (including omeprazole, fluvoxamine, cimetidine, fluconazole and others).~     Nevertheless there no clear evidence in the literature for clinical relevance of such~     interactions.~      Selective serotonin reuptake inhibitors (SSRIs) are group of antidepressant drugs that are~     widely used for treatment of depression and anxiety. SSRIs are considered to be very safe~     with favorable side effect profile, hence many patient after coronary events who suffers~     from behavioral and emotional disturbances are treated with those drugs. However there are~     several reports that SSRIs can inhibit platelet function and increase bleeding tendency~     particularly in concomitant administration with aspirin. The proposed mechanism is blocking~     of platelets serotonin reuptake that result in platelet dysfunction.~      Fluvoxamine - is a member in the SSRI family and a potent inhibitor of the CYP2C19.~     Theoretically fluvoxamine should have two conflicting effects on the response to~     clopidogrel. Pharmacokinetically it is expected to decrease the clopidogrel responsiveness~     due to inhibition of CYP2C19 and reduction in the production of the active metabolite. On~     the other hand pharmacodynamically fluvoxamine may directly inhibit platelet aggregation~     due its effect on serotonin reuptake, thus increasing the effect of clopidogrel. Other SSRIs~     that do not interact with the CYP2C19 such as citalophram are expected to have only~     pharmocodynamic effect on platelet aggregation.~      Although both clopidogrel and SSRIs are widely used in the last decade and concomitant~     treatment is quite common, no data is available about in influence of the interaction~     between those drugs on platelet function and on clinical events. The net effect of~     fluvoxamine and other SSRIs on platelet function in the presence of clopidogrel is not~     known.~      The aim of the investigators study is to assess the effect of two SSRIs fluvoxamine and~     citalophram on platelet aggregation and to test the effect of these drugs on the laboratory~     response to clopidogrel, in healthy individuals.~      Study design: randomized, double blinded, controlled crossover trial. Primary study end~     point: Change in % platelet aggregation and VASP phosphorylation after treatment with~     clopidogrel + fluvoxamine or clopidogrel + citalophram as compared to each drug alone.~   "
126735|NCT01396707|"~     This is an open-label, multicentre, prospective phase II trial designed to evaluate the~     efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as~     first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma~     of the stomach or gastro-oesophageal junction.~   "
126736|NCT01396694|"~     All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction~     will complete a psychological questionnaire prior to surgery. The 3 month outcomes including~     pain and function will be examined using regression analysis to identify psychological~     variables that may predict outcomes.~   "
126740|NCT01396642|"~     Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of~     these deaths are attributable to prematurity and infection. With the increasing rate of~     premature births in some settings, the mortality rate of over 50% among preterm babies in~     some of the developing countries require inexpensive hospital-based strategies to prevent~     fatal infections in newborns of these countries. As most of the deaths in preterm neonates~     are attributable to their vulnerability of infection, a potential low cost intervention like~     topical emollient therapy can be effectively directed to reduce infection related mortality~     and morbidity in the developing countries. Topical emollient therapy reduces the rate of~     infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss~     consequently conserving heat and energy to promote growth.~      The broad goal of the study is to improve the survival rate of hospitalized preterm neonates~     in the developing countries by decreasing the incidence of infection using low-cost~     interventions.~      HYPOTHESIS:~      It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day~     of life in hospitalized preterm neonates reduces the incidence proportion of hospital~     acquired infection by 40% 15 as compared to routine skin care. For the secondary objective~     it is hypothesized that the weight gain in the neonates receiving prophylactic application~     of emollient, which is coconut oil twice a day till 28th day of life, is at least~     2g/kg/day18 more as compared to the weight gain in the routine skin care group.~   "
126741|NCT01396629|"~     The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the~     implantation of foldable intraocular lenses.~   "
126742|NCT01396616|"~     The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational~     stability after implantation of TORIC IOL and to assess the post operative complications~     after implantation of TORIC IOL.~   "
126743|NCT01396603|"~     This study will evaluate a new imaging technology, termed optical frequency domain imaging~     (OFDI) for detecting and diagnosing pulmonary malignancy in the central airways.~   "
126744|NCT01396590|"~     The purpose of this study is to determine that six 2-mg tablets of perampanel are~     bioequivalent to one 12-mg tablet of perampanel.~   "
126745|NCT01396577|"~     The purpose of this study is to determine that three 2-mg tablets of perampanel are~     bioequivalent to one 6-mg tablet of perampanel.~   "
126746|NCT01396564|"~     HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin~     concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D).~      MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American~     Diabetes Association (ADA) were included, not under treatment or who had been treated~     exclusively with diet and exercise or who only received an anti-diabetic agent, as well as~     those with a history of insulin use who had not applied insulin within 1 month before the~     initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are~     recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin.~      STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of~     resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin~     concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired~     t test. Lineal or logarithmic regression analysis is used to evaluate the relationship~     between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin~     concentrations. The statistical significance between variables is determined using ANOVA.~     The effect of confounding variables is analyzed with a test of co-variance analysis.~     Statistical significance is considered as p <0.05.~   "
126747|NCT01396551|"~     Clinical study investigating the feasibility and safety of using an anchored Calypso~     transponder in the airways of the lung for real-time monitoring of tumor location during~     radiotherapy~   "
126748|NCT01396538|"~     Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical~     detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive~     referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to~     mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics~     by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc~     alone in patients with serum HBV DNA can be measured, then there may be occult HBV~     infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had~     significant differences in the prevalence (2.9 ~ 22.8%) (2), but prevalence survey in Taiwan~     there are very few studies on this , It is hoped to be able to investigation the prevalence~     of occult HBV infection Among Anti-HBc Alone.~   "
126749|NCT01396525|"~     To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable~     Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native~     common iliac artery and/or native external iliac artery.~   "
126750|NCT01396512|"~     The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus~     Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine~     [CD.JEVAX™]) after a single dose vaccination to support product registration.~      Primary Objective:~        -  To demonstrate the non-inferiority of the antibody response 28 days after~          administration of one dose of IMOJEV™ compared to the antibody response 28 days after~          administration of one dose of the CD.JEVAX™ control vaccine.~      Secondary Objectives:~        -  To describe the immune response to Japanese encephalitis (JE) in both vaccine groups~          using 50% plaque reduction neutralization assay (PRNT50) assays before and after a~          single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.~        -  To describe the safety of vaccination in all subjects up to 28 days and all serious~          adverse events up to 6-month after vaccination.~   "
126751|NCT01396499|"~     The goal of this clinical research study is to find the highest tolerable dose of BKM120~     that can be given to patients with relapsed or refractory leukemia. The safety of BKM120~     will also be studied.~   "
126752|NCT01396486|"~     The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus~     inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3~     fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the~     side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial~     with children ages 5-12 years old with bipolar spectrum disorders.~   "
126828|NCT01395485|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in~     adolescent and adult subjects with intermittent or mild to moderate persistent asthma.~   "
126754|NCT01396460|"~     Through the values of respiratory quotient (RQ) it is possible to estimate the utilization~     of energy substrates by the body, or if there is a higher or lower fat oxidation.~     Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP)~     there is a decrease in the values of RQ, which may be associated with increased lipid~     oxidation in the postoperative period.~      Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would~     like to know how it functions among RYGBP patients.~      The purpose of this study is to evaluate the RQ and DIT of patients in the post operative~     phase and compare the result with a control group consisting of morbid obese population.~   "
126755|NCT01396447|"~     The objective of this study was to evaluate the efficacy, safety, and tolerability of~     cariprazine relative to placebo for the treatment of patients with bipolar depression.~   "
126756|NCT01396434|"~     Prevenar 13 is safe for administration to Filipinos.~   "
126757|NCT01396421|"~     The purpose of this study is to compare the effectiveness, safety and tolerability of three~     different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.~   "
126758|NCT01396408|"~     This research is being done because there is no treatment that will cure this type of~     cancer. Although some types of chemotherapy can cause this cancer to shrink for a time,~     better options are needed.~   "
126759|NCT01396395|"~     This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart~     Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who~     are taking standard treatment with stable symptoms will receive a 24-hour ambulatory~     electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups.~     The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top~     of the standard treatment for 12 weeks, while the control group will stay on standard~     treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs~     that do not affect the primary endpoint may be adjusted per investigators decision.~   "
126760|NCT01396382|"~     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging.~     The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity~     and resolution specifically for neuroendocrine tumors. The investigators will scan people~     with this cancer and compare it to other conventional imaging methods to see if it improves~     patient care.~   "
126761|NCT01396369|"~     PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone~     levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the~     ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require~     2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum~     hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic~     ovaries.~      This study is a prospective randomized pilot study designed to evaluate the effects of~     flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in~     polycystic ovarian syndrome (PCOS) patients.~   "
126762|NCT01396356|"~     You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation.~     Complications of ablation procedures include damage to structures near the heart from the~     heat energy used during the ablation procedure. These complications include damage to the~     esophagus (the tube through which food passes when you swallow) and stomach. A rare but~     often fatal complication resulting from severe heat damage is called an atrio-esophageal~     fistula (an abnormal connection between the heart and esophagus). However, the frequency of~     minimal damage to the esophagus or nerves of the gut that may go unnoticed are not known.~      This study is designed to determine how often atrial fibrillation ablation causes problems~     with the stomach and esophagus.~   "
126763|NCT01396343|"~     The purpose of this study is to better understand multiple sclerosis (MS) in children and~     adolescents, to learn if it differs from adult MS and to investigate if genes or~     environmental exposures or a combination of both put children and adolescents at risk for~     getting MS.~   "
126764|NCT01396330|"~     Introduction Stress is part of the investigators daily life, and means to cope with it allow~     adaptation and survival. To this end, physiological pathways are activated, including~     neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of~     consequences are beneficial, in the long run, however, chronic psychosocial stress may~     constitute an increased risk for coronary heart disease, type 2 diabetes, and disability.~      Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and~     cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but~     also to increase blood glucose levels. In clinical practice, patients and health care~     providers are often confronted with questions concerning psychological stress as a possible~     reason for glucose fluctuations. Whether stress itself or poor treatment adherence is~     responsible for the altered glucose control remains often controversial. Differences in the~     inter- and intraindividual response to stress have been suggested, but only a few small~     studies have addressed the effect of acute psychological stress on glucose control in~     patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute~     psychological stress on glucose control but further studies are clearly needed to definitely~     exclude or confirm a relevant effect of stress on the glucose control in diabetic patients.~     For example, effects of longer lasting or repetitive events of psychological stress on~     glucose concentrations still remain elusive. The aim of the present study was therefore to~     investigate the effect of prolonged psychological stress by means of repetitive safe driving~     training courses on glucose control in patients with diabetes.~      Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending~     the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for~     regular visits are invited to participate. Included are patients on any oral~     glucose-lowering treatment and at least one daily injection of insulin, a valid driver~     license and written informed consent given. Exclusion criteria are diabetes duration <2~     years, pregnancy, unstable coronary artery disease, limited visual acuity or unstable~     proliferative diabetic retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary~     or adrenal disease. The Ethics committee of the Kanton Thurgau approved the protocol and the~     study conform to the principles outlined in the Declaration of Helsinki.~      Study protocol Each patient completes a control and a stress testing day which takes place~     consecutively in a randomized order. Randomization is performed by an uninvolved third~     person. The study is carried out at the driving training area of the Touring Club~     Switzerland at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain~     from food thenceforth. Drinking mineral water remains allowed during the entire study days,~     and the patients have to take their basal insulin and other medication as usual. Patients~     are advised to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a~     capillary glucose measurement is carried out, and glucose concentrations ≥10mmol/l are~     corrected with short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no~     additional adjustment with insulin is allowed during the study. Glucose concentrations~     ≤4mmol/l are always corrected with administration of 10g carbohydrate (DextroEnergy® or~     orange juice). On both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min~     before the driving training). Immediately after the meal, short-acting insulin is injected~     in knowledge of the carbohydrate content (same dose on both days) or oral antidiabetics are~     ingested as usual. Measurements of capillary and plasma glucose concentration, blood~     pressure, heart rate, stress perception and salivary cortisol concentration are carried out~     in regular intervals between 4 and 9 p.m. on both study days.~      On the control day, patients are placed in a quiet room and are permitted to read. They also~     have the possibility to leave the room and stay on a balcony.~      On the stress testing day, patients complete a driving training with their car between 5 and~     7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on~     dry and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the~     car is hurled around by a mechanical plate and the patients has to regain control over it.~   "
126765|NCT01396317|"~     This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess~     the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in~     patients with polymyalgia rheumatica (PMR).~   "
126766|NCT01396304|"~     Calcium alginate dressings with silver have been found to be safe and effective for use for~     leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to~     AqualCel Ag Dressing on the following parameters: No further progression toward infection~     (bioburden), ease of application and removal, and percent progression to closure. The~     secondary objective is to obtain photographic documentation of the leg ulcers during the~     course of the study.~   "
126767|NCT01396291|"~     This study is being done to evaluate the efficacy and safety of asenapine as compared to~     placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic~     mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each~     participant will receive open-label asenapine and matching placebo for 12 to 16 weeks.~     Participants who meet stabilization criteria may then be randomized into one of the two~     study arms (asenapine or matching placebo) to receive double-blind treatment for up to an~     additional 26-weeks.~   "
126768|NCT01396278|"~     The aim of the study is to assess and compare efficacy and safety of BI 54903 at three~     different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose~     inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d.~     over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately~     controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume~     in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or~     greater than 1.5 at time of randomisation.~   "
126769|NCT01396265|"~     The objective of the current study is to investigate the effect of the P-gp inducer~     rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers~   "
126770|NCT01396252|"~     The purpose of this clinical study is to assess the safety and tolerability of multiple oral~     doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.~   "
126771|NCT01396239|"~     This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics~     (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24~     weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).~   "
126772|NCT01396226|"~     Medical Products Agency~   "
126774|NCT01396200|"~     The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii)~     hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse~     dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as~     the feasibility of obtaining multiple blood and bone marrow samples during treatment to~     assess the pharmacodynamic effects of the treatment.~   "
126775|NCT01396187|"~     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability~     and pharmacokinetics of multiple ascending doses of PF-05231023.~   "
126776|NCT01396174|"~     The investigators hypothesize that breast cancer survivors participating in a prosocial~     online support group will have a significantly lower mean level of psychological symptoms~     (anxiety/depression) and higher mean level of sense of purpose post-intervention than~     participants in a standard online support group.~   "
126777|NCT01396161|"~     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics~     and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and~     patients with type 2 diabetes mellitus.~   "
126778|NCT01396148|"~     Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with~     sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be~     studied in these patients. In addition, tumor responses and overall survival will be~     assessed.~   "
126779|NCT01396135|"~     This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The~     pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be~     evaluated in Japanese, healthy, non-smoking subjects.~   "
126780|NCT01396122|"~     The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE~     PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ~     Prolapse.~   "
126781|NCT01396109|"~     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms~     such as loss of control of the bowel or bladder, and may also cause problems with patient's~     sex life. The primary treatment is surgery, sometimes a mesh is placed in the pelvis to~     support the weakened tissues, but mesh implants can cause complications.~      This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic~     floor repair system compared with the modified total pelvic floor reconstructive surgery~     with mesh for the treatment of uterine prolapse.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
126782|NCT01396096|"~     This proposal is designed to (1) establish the feasibility of a research strategy for~     discovering ethnic differences in the frequency of genotypes in patients after bariatric~     surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to~     identify genetic factors that may influence the success of various surgical weight loss~     interventions and determine whether these factors are associated with specific patient~     populations.~   "
126783|NCT01396083|"~     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone~     implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a~     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0~     with sham injections PRN afterwards.~   "
126784|NCT01396070|"~     The purpose of this study is to learn the effects of an investigational medication, SGN 35,~     on patients with mycosis fungoides. Despite a wide range of therapeutic options, the~     treatments are associated with short response duration, thus this condition is largely~     incurable. This investigational drug may offer less toxicity than standard treatments and~     have better tumor specific targeting.~   "
126785|NCT01396057|"~     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone~     implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a~     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0~     with sham injections PRN afterwards.~   "
126786|NCT01396044|"~     Medical errors account for tens of thousands of deaths and tens of billions of dollars in~     healthcare costs in the United States every year. One field that has seen the strongest push~     toward quality improvement has been critical care medicine, likely because its particularly~     high degree of medical complexity makes it a practice area prone to high error rates with~     serious consequences. One of the most commonly used interventions used to help reduce errors~     in the intensive care unit (ICU) has been the implementation of checklists.~      The investigators propose a clinical trial in a University critical care setting to~     determine whether an electronic checklist versus verbal prompting to use a written checklist~     improves clinical practice and patient outcomes. The investigators also plan to compare~     these data with a time period prior to the study to determine if the electronic checklist or~     verbal prompting are better than usual care. The investigators hypothesize that both the~     electronic checklist and verbal prompting to use a written checklist will be better for~     clinical practice and patient outcomes than usual care, and that verbal prompting will lead~     to better outcomes compared to the electronic checklist.~   "
126787|NCT01396031|"~     Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and~     hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT)~     are screened for functional status among other criteria to ensure that they are able to~     endure the rigorous treatment involved during Hematopoietic stem cell transplantation~     (HSCT). The patient entering the transplant process is possibly already functionally~     compromised from their disease, prior cancer treatment, and possible other co-morbidities.~     Additional factors of the transplantation that compromise the independent functional status~     of the patient include the high dose preparative regimen, pancytopenia, steroid-related side~     effects, hospitalization, transplantation complications such as infections, pulmonary~     alterations, acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional~     input, and other sequelae of transplantation.~      Physical Therapy has been utilized in this population primarily as a supportive therapy to~     prevent and limit the patient's functional decline. Studies have addressed general and~     aerobic exercise in this population but there is a paucity of research investigating the~     benefits of a strength-training program, particularly performed in weight-bearing, in~     attenuating the detrimental effects of the transplantation on functional status.~      This is a feasibility study questioning if an exercise program including weight-bearing~     strengthening exercises and cardiovascular exercise is practical for the patients to carry~     out as inpatients. The study will also preliminarily determine if this exercise program~     influences functional outcomes and level of fatigue. Such outcome measures will include 1)~     FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional~     Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional~     Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.~      The study population will include patients with lymphomas and acute leukemias undergoing~     matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).~   "
126789|NCT01395992|"~     Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for~     eligibility for this 26-week extension study in which they will continue treatment. The~     primary purpose of this trial is to evaluate the long-term safety of asenapine.~   "
126790|NCT01395979|"~     Brief Summary: The specific aims of this study are:~        1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing~          therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in~          HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual~          abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse~          (number and proportion) with serodiscordant partners. The investigators will also~          examine the intervention effect on CSA-related trauma symptom severity and cognitions~          and behaviors.~        2. To examine the degree to which intervention-related reductions in sexual risk behavior~          are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.~        3. To examine the degree to which the intervention reduces incident sexually transmitted~          infections (STIs) during the study period, as well as to explore additional potential~          moderators and mediators of intervention efficacy.~      Study hypotheses:~        1. For the primary outcome, the investigators hypothesize that those who receive the~          intervention will have reduced transmission-risk behavior.~        2. For the secondary outcome, the investigators hypothesize that those who receive the~          intervention will have reduced trauma symptom severity (cognitions and behaviors).~   "
126791|NCT01395966|"~     The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and~     effective in treating middle ear infections in children with ear tubes.~   "
126792|NCT01395953|"~     The main objective of this exploratory 8 week pilot study is to evaluate the safety and~     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism~     spectrum disorders. The study results will be used to generate hypotheses for a larger~     randomized controlled clinical trial with explicit hypotheses and sufficient statistical~     power.~   "
126793|NCT01395940|"~     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients~     with endometriosis.~   "
126794|NCT01395927|"~     The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers~     before and after the administration of multiple-doses of rifampin.~   "
126795|NCT01395914|"~     The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia~     (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle~     strength.~   "
126796|NCT01395901|"~     The primary objective of this study is to evaluate the efficacy of a single palonosetron IV~     dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and~     vomiting through 24 hours after surgery in children aged from neonates up to less than 17~     years undergoing elective surgical procedures requiring general intravenous anesthesia. The~     secondary objective is to evaluate the safety and tolerability of IV palonosetron in~     pediatric patients.~   "
126797|NCT01395888|"~     This study is designed to evaluate the effect of fluticasone furoate (FF,~     GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness~     compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic~     pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as~     aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group,~     multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the~     randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment~     period. There will be an approximate 7-day Follow-up period after the treatment period.~   "
126798|NCT01395875|"~     Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of~     all diagnosed COPD patients. Yet limited data exists on characterizing this study population~     in terms of drug therapy patterns and COPD-related resource use and costs. The objective of~     the following study was to conduct an analysis in the real-world setting to (1) identify and~     characterize COPD patients with moderate exacerbations and (2) evaluate the impact of~     initiating different maintenance therapies in this population. Maintenance therapy~     medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs),~     combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and~     ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium~     [IPR]).~   "
126799|NCT01395862|"~     The purpose of this study is to detect adverse drug reactions for long-term use~     (particularly clinically significant adverse drug reactions) occurring in clinical settings,~     to examine factors likely to affect the safety and efficacy in the Japanese asthma patients~     who are treated with fluticasone propionate/salmeterol xinafoate.~   "
126800|NCT01395849|"~     The purpose of this post-marketing surveillance is to detect adverse drug reactions~     (particularly clinically significant adverse drug reactions) occurring in clinical settings,~     to examine factors likely to affect the safety and efficacy in the Japanese asthma patients~     treated with fluticasone propionate and salmeterol xinafoate.~   "
126801|NCT01395836|"~     One common occurrence following open heart surgery is an irregular rhythm from the top~     chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30%~     of patients who have had bypass surgery without having a heart valve replaced at the same~     time will develop AF. It is felt that this occurrence leads to factors that will affect a~     subjects health for the rest of their life. In studying this the investigators will see if~     post operative afib is an indicator of a person having afib and is not a condition that may~     only last during the post op recovery period as many physicians feel.The problem in question~     is, is post operative afib only transient or is it an indicator for more long term episodes~     of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to~     participate. There will be to groups of 25 subjects. All subjects will have a device~     implanted under the skin that will be able to detect all types of heart rhythms. One group~     will get standard treatment and the physicians will be blinded to the recordings. The other~     group will be treated by the recording and the information about the amount of time in afib.~     The purpose of the study is to determine what the true occurrence of afib is for the first~     year after open heart surgery and to see if knowing this will alter the clinical management~     of this group of subjects.Currently most subjects are treated without knowing this~     information and based on that the arrhythmia will no longer happen after the heart is healed~     or recovered from the surgery. Most medications for controlling the heart rate and rhythm~     are stopped around 3 months. There is also a tendency to not to use blood thinning~     medications for the prevention of stroke after this time period. Stroke is one of the major~     complications from afib. Not all subjects are aware of the irregular heart beats so you can~     not depend on them to accurately know. They might feel episodes of very fast beating~     episodes or may become weak and fatigued. Weakness and fatigue are also normal during the~     first parts of recover from bypass surgery. By documenting the true episodes of afib the~     investigators can better understand if postoperative afib might need to be treated as a life~     long issue rather than a transient post operative issue. This treatment might change~     clinical management and decrease mortality.~   "
126802|NCT01395823|"~     A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after~     25D supplementation, but only one of these is a prospective clinical trial, and it is a~     small, single center study lacking a control arm. The investigators propose to conduct a~     double blind, randomized, placebo controlled clinical trial of ergocalciferol~     supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing,~     active D dosing, and mineral metabolic parameters in hemodialysis patients.~   "
126803|NCT01395810|"~     This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is~     to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after~     long-term exposure in patients with haemophilia B.~      This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773~     (NCT01386528/paradigm™ 3).~   "
126804|NCT01395797|"~     The goal of the proposed research is to improve the effectiveness of treatments for opioid~     and for nicotine dependence by testing a novel pharmacological strategy. Specifically,~     pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be~     used as an adjunct to agonist-based treatment.~   "
126805|NCT01395784|"~     The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been~     characterized in a controlled laboratory setting. Accordingly, the proposed investigation~     seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused~     opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this~     investigation is to characterize the subjective effects of oxycodone under maintenance on~     various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers.~     Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive,~     and physiological effects of oxycodone.~   "
126806|NCT01395771|"~     The adherence rate (95%) to HAART in the intervention group which receives a phone call will~     be higher than that(75%)of control group which does not receive a phone call.~   "
126807|NCT01395758|"~     The purpose of this study is to evaluate progression-free survival among subjects with KRAS~     mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib~     (ARQ 197) compared to single agent chemotherapy.~   "
126808|NCT01395745|"~     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod~     administered in addition to standard therapy in subjects with active Systemic Lupus~     Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable~     corticosteroid therapy.~   "
126809|NCT01395732|"~     The effect of bosentan on digital ulcers (DU) was studied in two randomized~     placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the~     heterogeneous study population. More importantly, there were no endpoints that assessed~     changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to~     effectively demonstrate blood flow restrictions in the hands of patients with Systemic~     Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser~     Doppler imaging and the extent of DU disease has not been studied. The current study will~     attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow~     in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2~     years and a clinically relevant reduction of blood flow in the hands, will be assessed.~   "
126810|NCT01395719|"~     The purpose of this study is to determine whether remote ischemic conditioning can improve~     the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is~     performed on the patient receiving a kidney from a deceased donor. Remote ischemic~     conditioning is done during the operation by inflating a tourniquet on the patients leg~     before opening the blood circulation to the kidney. The study focus on both the immediate~     kidney function after the transplantation, but also on the extended kidney function one year~     after the transplantation.~   "
126811|NCT01395706|"~     Objectives of Clinical Trial~      The main objective of this clinical trial is to show the efficacy of fluorescence~     lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.~   "
126812|NCT01395693|"~     Assessment of the performance of the Salt Lake mask system acting as a patient interface in~     the provision of PAP therapy. This study will assess the suitability of this mask system in~     its current form for use.~   "
126813|NCT01395680|"~     Family resilience is an important strength to help family to manage life challenge~     successfully, and to reorganize family function. However, few studies have showed the~     trajectory of family resilience in adolescents with cancer over time. The purposes of this~     study are to know the trend of family resilience in adolescents with cancer from previous 3~     months to the first year of newly diagnosed, and to examine the relationships among family~     members' stress, family satisfaction, and family resilience in adolescents with cancer.~   "
126814|NCT01395667|"~     In this phase I trial neoadjuvant CCRT combining IMRT with three escalated dose levels (45~     Gy, 50 Gy, and 55 Gy in 25 fractions) and BV-fluorouracil/ leucovorin/oxaliplatin (FOLFOX)~     regimens is planned for 15 locally advanced rectal cancer patients. The primary goal is to~     define the maximally tolerated dose of radiotherapy and the treatment related acute~     toxicity, and to demonstrate that preoperative highly conformal IMRT and concurrent~     BV-chemotherapy will lead to acceptable acute gastrointestinal morbidity. The secondary goal~     is to demonstrate that this treatment modality will elicit a comparable or improved rate of~     T stage downstaging and complete response pathologically.~   "
126815|NCT01395654|"~     Despite the availability of effective anti-tuberculosis agents that exist to treat this~     illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as~     isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use.~     There is no consensus on method of the reintroduction of anti-TB medications. The risk of~     reintroducing of a anti-TB medications could be hazardous. There are several differences~     between the guidelines from the ATS, BTS and the Task Force of the European Respiratory~     Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the~     methods of reintroducing of anti-TB medications.~      The investigators plan to do a prospective study to evaluate the outcome and safety of~     reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment~     among TB patients in the investigators hospital.~   "
126816|NCT01395641|"~     This Phase I/II trial is to prove the efficacy and safety of AAV2-hAADC to treat patients~     with AADC deficiency.~   "
126817|NCT01395628|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about cancer and the development of drug resistance in patients.~     It may also help doctors find better ways to treat cancer.~      PURPOSE: This research trial is studying samples from patients with leukemia.~   "
126818|NCT01395615|"~     This observational study will assess the health related quality of life (HQRL) profiles of~     patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data~     will be collected from patients currently receiving therapy and from those who have finished~     therapy and have undergone an assessment of treatment.~   "
126819|NCT01395602|"~     The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine~     receptor agonist, on body weight and blood glucose in healthy obese adults.~      This is a randomized double-blind placebo controlled study. Twenty subjects each will be~     randomly assigned either placebo or cabergoline for 16 weeks.~      The effect of treatment on body weight and blood glucose and insulin levels will be compared~     in the treatment versus the placebo arm.~   "
126820|NCT01395589|"~     Asthma is a major health problem affecting 22 million in the USA and 300 million people~     worldwide.~      Recently vitamin D was identified as a possible co-factor and found that low vitamin D was~     associated with increased steroid use. In Qatar the prevalence of vitamin D deficiency among~     health care professionals was reported as high as 87% and 68.8% among school children.~      In 1 year prospective study of patient with vitamin D and moderate -severe asthma will be~     followed after slow versus fast correction for asthma control.~      This is randomized clinical trial study. INCLUSION CRITERIA: Children 2-14 years of age with~     moderate to severe asthma and proved to be Vitamin D deficient by serum level will be~     included in this study.~      EXCLUSION CRITERIA: Prematurity (Gestational age 34 weeks or less),Patients on vitamin D~     therapy,Patients on seizure medication or diuretics,Patients on chronic steroid use for~     other reasons than asthma,Patient with chronic liver or kidney disease,Patients with~     inherited bone disease,Patients with hypo or hyper parathyroidism,patients with history of~     chronic lung disease other than asthma Methodology:- On arrival, patients with asthma with~     exacerbation will be assessed by the emergency staff. Children aged 2-14 years admitted to~     the inpatient/short stay unit for the treatment of moderate-severe asthma, meeting inclusion~     and exclusion criteria will be eligible for the study.~      Guardians of eligible patients will be approached regarding the study, explaining the~     purpose and the treatment modalities. Patients will be included after obtaining a verbal~     consent.~      All patients will be treated as usual. Blood sample for 25OH cholecalciferol level will be~     sent before discharge. Patients with vitamin D deficiency will be called to receive either~     daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D~     will be repeated at 3,6,12 months. Followed up will continue for 1 year with a structured~     phone call interview by a research assistant at the first week of each month filling the~     survey for the previous month.~      Ethical Considerations: Informed consent will be obtained from the guardian.~      Sample Size:~      a total of 105 patients will be recruited under this study. Statistical Analysis:-~     Univariate and multivariate analysis will be performed as required. Cox proportional hazards~     model will be used to compare the two treatment groups.~   "
126821|NCT01395576|"~     Post stroke patients often suffer from decrease in strength, loss of balance and gait~     asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury.~     The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the~     quadriceps in combination with hamstrings weakness, causes knee hyperextension, which~     increases the stance phase duration and makes it difficult to achieve symmetrical gait.~     Additionally, this gait disorder can be painful as a result of stress to the ligaments and~     tendons at the posterior aspect of the knee.~      The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and~     prevent hyperextension. In order to assess the effect of the orthosis on the gait and~     balance characteristics of stroke patients the investigators will conduct subjective~     patient's satisfactory questionnaire, complete physical and functional evaluation and gait~     analysis, as well as dynamic electromyography (EMG) muscle activation patterns. These~     examinations will be performed 3 times: at the beginning of the trial, after one month and~     after two months. The trial design is explained in the following paragraph.~      The investigators hypothesize that the gait pattern will be improved while using the knee~     orthosis,as will be expressed by smaller base width and faster walking velocity etc.~   "
126822|NCT01395563|"~     The purpose of this study is to determine whether prednisone, methotrexate, and~     cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both~     ears due to autoimmune inner ear disease (AIED).~   "
126823|NCT01395550|"~     AstraZeneca was interested in knowing how Cardiologists and Physicians treat patients who~     have suffered a cardiovascular event.~   "
126824|NCT01395537|"~     RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent~     for the treatment of esophageal and GEJ tumors.~      PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in~     combination with capecitabine or letrozole. It is hoped that by giving lapatinib and~     carboplatin and paclitaxel together, their combined effects will further slow or stop the~     cancer cells from growing.~   "
126825|NCT01395524|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.~   "
126826|NCT01395511|"~     The purpose of this study is to determine whether acupuncture is effective and safe~     therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and~     discomfort due to Whiplash associated disorder. (Traumatic car accidents)~      We recruit 40 participants who had cervical, shoulder and upper extremity pain and had~     discomfort due to Whiplash associated disorder. And then we check initial data of 40~     participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)~      40 participants were randomly allocated to two groups ; acupuncture group or waiting-list~     group.~      Acupuncture group: participants were given acupuncture treatment three times a week during 2~     weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check~     information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)~      Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2~     weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)~      The waiting-Patients in both groups were permitted to receive usual care including physical~     therapy and exercise and were not permitted to take analgesics and antiphlogistics during~     the trial periods.~   "
126827|NCT01395498|"~     The purpose of this study is to determine the incidence of the carriage state~     (asymptomatic colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia,~     PCP) and Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in~     patients with suppressed immune system, but not known to cause disease in otherwise normal~     people. The investigators hypothesis is that a carriage state exists for these two~     pathogens. To test this hypothesis the investigators will examine bronchoalveolar lavage~     fluid for genetic material of these two pathogens. The study population will be patients~     undergoing fiberoptic bronchoscopy and lavage for indications other than diagnosis of a~     presumed opportunistic infection.~   "
126829|NCT01395472|"~     The aim of this study is to determine the effects of an acute session of physical exercise~     on cognitive functioning and humor of traumatic brain injury patients and to investigate~     whether different cognitive responses can be achieved with different intensities of exercise~     (moderate and vigorous).~      The investigators hypothesize that while moderate intensity physical exercise may be~     beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients,~     as physical fatigue may impair alertness and other higher cognitive functions.~   "
126830|NCT01395459|"~     Parent study:~      A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of~     two intervention arms (described below) intended to increase breast, cervical, and colon~     cancer screening rates among patients served by community health centers. A central focus of~     CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among~     populations facing significant cancer disparities.~      CATCH was conducted in partnership with the large health clinic in Massachusetts, which~     serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice~     Response (IVR) telephone technology system, the study is examining the extent to which the~     IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be~     conducted to inform the intervention), can improve breast, cervical and colon cancer~     screening rates compared to a control group. Furthermore, we plan to determine if pairing~     IVR with telephone calls from a prevention care coordinator (PCC) will result in higher~     screening rates (when compared to the IVR only group). We will determine the~     cost-effectiveness of IVR alone vs. IVR + PCC.~      Substudy:~      We conducted a substudy of the parent study, looking at a comparison of return rates of two~     colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal~     Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types~     of tests to assess barriers and facilitators of returning the completed kit to the health~     center for assessment.~   "
126831|NCT01395446|"~     The purpose of this study is to establish the accuracy with which the eNose can discriminate~     patients with invasive pulmonary aspergillosis from controls.~   "
126832|NCT01395433|"~     This is a bioequivalence study, which is a regulatory requirement to ensure comparable in~     vivo performance, i.e. similarities in terms of safety and efficacy, after administration of~     two different dosage forms of escitalopram.~      All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg~     of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being~     tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test~     treatments B and C will each be compared to Treatment A, which is the active comparator~     (reference formulation).~   "
126833|NCT01395420|"~     This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration~     of Avibactam and Ceftazidime in the lining of the lungs and the blood.~   "
126834|NCT01395407|"~     Brain metastases are the most common adult intracranial tumor, occurring in approximately~     10% to 30% of adult cancer patients, and represent an important cause of morbidity and~     mortality in this population. The standard of care for solitary brain metastasis is surgery~     followed by whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high~     levels of local failure that occur. Local recurrence rates ranged from approximately 45% at~     1 year to 60% at 2 years after resection alone. However, aside from improvements in~     intra-cranial control, it is well documented that WBRT is associated with serious long term~     side effects, including significant decline in short term recall by as early as 4 months~     after treatment.~      Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after~     resection alone to improve local control while avoiding the negative effects of WBRT. There~     have been several retrospective studies on the use of SRS to the resection cavity alone,~     from which the 1 year actuarial local control rates range from 35% - 82%. The high rate of~     in-field local failure suggests that the current dosing regimen used may not be high enough~     for adequate local control. Currently, the highest local control rates are approximately~     80%, but there may be room for improvement with increased dose without significantly~     increasing the risk of side effects.~      The investigators propose a trial for patients after surgical resection of solitary brain~     metastases. The purpose of this trial will be to determine the maximum tolerated dose for~     single fraction SRS to the resection cavity. There will be three groups based on the~     resection cavity size. Dose escalation enrollment will be done sequentially within each~     cohort. You will know which cohort and which specific dose level you are randomized to.~     After treatment, which will take one day, regardless of cohort, you will be followed closely~     for treatment outcome and possible side effects. You will be asked to complete three quick~     surveys at each follow-up appointment regarding quality of life and memory in addition to~     standard of care surveillance brain MRI and physical exam.~   "
126835|NCT01395394|"~     The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as~     sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial~     function in patients with Phenylketonuria (PKU).~   "
126836|NCT01395381|"~     The benefit of anti-worm therapy as part of the case management of severe acute malnutrition~     (SAM) in the outpatient setting has not previously been studied. This study will compare~     recovery rates of children with SAM treated in the community with locally-produced~     ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of~     their case management.~   "
126837|NCT01395368|"~     Tinnitus, commonly referred to as ringing in the ears, affects 50 million people in the~     United States and is recognized as a major public health concern. Tinnitus is the most~     frequent cause of service-connected disability claims among war veterans. Tinnitus remains a~     subjectively diagnosed entity. There is no standardized objective method of diagnosing~     tinnitus or describing the functional impact of the condition. Currently, physicians have to~     rely on patient-based self reports. Without an objective method of diagnosing tinnitus and~     describing the functional implications, adequate treatment delivery is also hampered since~     there is no way to objectively stratify patients into severity groups and assess response to~     treatment. Because tinnitus is known to negatively affect cognition through the ventral~     attention networks and the prefrontal cortex, measuring cognitive processing speed is a~     possible way to objectively measure tinnitus. This study builds on previous work the~     investigators have done that utilized a quick, easily accessible measure of auditory~     processing speed. That earlier study showed a correlation between that measure and self~     reported measures of tinnitus severity, and this study attempts determine a more precise~     estimate of that correlation. It also better validates those results by including a~     traditional neurocognitive measuring cognitive speed and by controlling for the presence of~     depression and somatoform disorders.~   "
126838|NCT01395355|"~     This study aims to develop a manualized and culturally sensitive intervention for adolescent~     girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the~     feasibility and acceptability of the intervention in a controlled pilot trial. The~     investigators hypothesize that this intervention will serve to reduce binge and LOC eating,~     as well as improve psychosocial functioning as evidenced by decreased depression, anxiety,~     eating disorder cognitions, and impulsivity, and improved quality of life.~   "
126839|NCT01395342|"~     Introduction:~      Hypertensive disorders during pregnancy are an important issue in global public health. It~     is current the leading cause of maternal mortality in Brazil.~      Objective:~      To assess the effect of physical exercise using stationary bicycle through blood pressure~     and heart rate measurements, incidence of pre-eclampsia and quality of life survey in~     pregnant women with chronic high blood pressure, previous preeclampsia pregnancies or both~     factors associated comparing to a group with no intervention. Verify the type of births,~     maternal and perinatal outcomes in both groups. Methodology: This randomized clinical trial~     enrolled pregnant women presenting chronic hih blood pressure, previous pre-eclampsia~     experience or both. Women from 12 to 20 gestational weeks were selected from the prenatal~     outpatient clinic and randomly allocated to the study or non-interventional group. Women at~     the study group performed physical exercise using stationary bicycle (horizontal bench~     model) during 20 minutes, once a week. The heart rate was maintained at 20% above resting~     heart rate and up to 140 bpm. Blood pressure and heart rate measurements were evaluated~     before and after exercise. The non-intervention group followed regular prenatal routine with~     weekly returns for heart rate and blood pressure measurements. Both groups fulfilled the~     quality of life survey (SF-36 questionnaire) at three times: between 12 and 20 weeks; 28 and~     32 weeks and 36 and 41 weeks of gestation. After that data of parturition will be analyzed~     to compare the incidence of pre-eclampsia, types of birth, maternal and perinatal outcomes.~   "
126840|NCT01395329|"~     The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone~     in adult humans with elevated blood pressure to a greater extent than either metoprolol or~     placebo.~   "
126841|NCT01395316|"~     The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to~     protect the brain from inflammation and how it may enhance repair through remyelination.~   "
126842|NCT01395303|"~     Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one~     would expect these polymorphisms to be associated with vitamin D related conditions and~     diseases, which will be tested in the present study including DNA analyses in 9700 subjects~   "
126843|NCT01395290|"~     There are indications that the vitamin D status of an individual is related to~     susceptibility to staphylococcal infections. In the present study we will examine nasal~     colonisation rate in subjects participating in an ongoing vitamin D intervention study (~     20.000 IU cholecalciferol per week vs placebo) for the prevention of type 2 diabetes in~     subjects with impaired glucose tolerance.~   "
126844|NCT01395277|"~     Groups of naturally occurring compounds called flavonoids are found in foods such as fruits~     and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids~     are associated with decreased risk for cardiovascular disease and major cardiovascular~     events (i.e. myocardial infarction) and have been shown to improve blood pressure, insulin~     sensitivity, and vascular function in a variety populations (Type II diabetes, elderly,~     smokers, etc.). The presumed beneficial effects of these compounds are thought to act~     through their inherent ability to scavenge free radicals. Specifically flavonoids scavenge~     superoxide anions which are free radicals that react with nitric oxide (NO) to produce~     peroxynitrite. The formation of peroxynitrite ultimately reduces the bioavailability of NO~     which is essential for vasodilation and thus vascular health and function. Normal aging is~     associated with impaired endothelial function, which presumably is due to less than optimal~     levels of NO bioavailability. Therefore, interventions that can increase NO bioavailability~     would be expected to improve microvascular function and vascular health in this population.~     The purpose of this study is to investigate the effects of dietary flavonoid supplementation~     on the vasodilatory capacity of the cutaneous vasculature, as well as on cerebral vascular~     reactivity and arterial stiffness in young and old humans. This study will test the~     hypothesis that acute dietary flavonoid treatment will improve impaired cutaneous~     vasodilatory capacity, cerebral vasomotor reactivity, and reduce arterial stiffness in older~     but not young humans.~   "
126845|NCT01395264|"~     Migraine is one of the commonest neurological disorders, affecting up to 12% of the general~     population, but remains relatively under-diagnosed and under-treated. Migraine has a wide~     socioeconomic impact and brings a large economic burden; estimates suggest that disability~     due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and~     impact, migraine pathophysiology is poorly understood. A wider understanding of the~     functional changes in this disorder would be beneficial to both diagnosis and treatment.~      Saccades are the rapid eye movements we make when moving the eyes to a new object in our~     visual field. Reaction time studies have been used to investigate Huntington's disease and~     Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements).~     Even at rest we make approximately three saccades per second, so a lot of data can quickly~     be gathered with non-invasive testing. We hope to understand more of the underlying~     mechanisms of migraine by studying reaction time in migraine patients.~      Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at~     fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed~     significantly different saccadic patterns to non-migraineurs.~      This study firstly seeks to corroborate the saccadometric findings of our earlier pilot~     study in a group of migraineurs, and secondly to explore the specificity of these findings~     in migraine by also studying patients with another primary headache syndrome, namely cluster~     headache.~      Migraine is known to be a dynamic disorder, with previous studies showing longitudinal~     changes in the migraine brain. To explore this further we hope to record longitudinally~     (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal~     changes in saccadic reaction time. Because of the portability of the equipment this could be~     done in the subjects own home if they preferred.~   "
126846|NCT01395251|"~     Rheumatoid arthritis is an inflammatory joint disease often leading to progressive joint~     destruction. To prevent disability caused by inflamed joints early diagnosis is important.~     Early diagnosis might be a challenge because the diagnosis is mostly based on clinical signs~     like swelling of small joints. In clinical practice a therapy with prednisolone is started~     although the patients do not have an exact diagnosis. In this cases the prednisolone might~     serve as a diagnostic test for an inflammatory process.~      The objective of this study is to investigate the diagnostic value of oral prednisolone test~     for rheumatoid arthritis.~   "
126847|NCT01395238|"~     This study focuses on the development of the Fathers Supporting Success in Preschoolers~     (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading~     to engage fathers in and improve parenting and child behavior.~   "
126928|NCT01394185|"~     The number of people seeking treatment for marijuana-related problems is on the rise, yet~     there is no currently accepted medication proven to help them quit. This research is~     designed to determine whether the FDA approved medication dronabinol (Marinol®) has effects~     that might help make it easier for people to stop daily marijuana use, and to carefully~     study the occurence of safety risks and side-effects at different doses of the drug.~   "
126848|NCT01395225|"~     When the bladder is removed for bladder cancer, pelvic lymph nodes (LN) are also removed.~     While the anatomic extent of this LN dissection is critical, the investigators often use the~     number of LN removed as a measure of the extent, which in turn is essential for determining~     the patient's further treatment and prognosis. The LN count, however, is also dependent on~     the pathologist's processing of the LN tissue, and the standards for this processing are~     poorly defined. The goal of this study is to establish a standardized method for processing~     and analyzing lymph node specimens. The investigators hypothesize that if an organic solvent~     is used to remove excess fat from the lymph nodes that the investigators will discover more~     clinically significant nodes in a more reproducible fashion when compared to the current~     method.~   "
126849|NCT01395212|"~     The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined~     (intramyocardial and intracoronary) delivery of autologous BM-MNCs.~      The clinical endpoint of this prospective non-randomized observational study is the MACCE,~     defined as major adverse cardiac and cerebrovascular events. Patients will be investigated~     by echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging~     will refine the evaluation with more exact analysis of the intramyocardial injected areas~     (ROI).~   "
126850|NCT01395199|"~     This study aims to investigate the use of amlodipine, a drug that blocks the uptake of~     calcium into cells, in the prevention and treatment of iron overload in patients with~     thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas~     and other organs, blocking these channels might help to prevent the accumulation of iron in~     these tissues. The study will follow 60 patients with thalassemia major: 30 will receive~     amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind~     fashion. Patients will be monitored through one year. Monitoring will occur through the~     measurement of blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12~     months.~   "
126851|NCT01395186|"~     there are many studies studying the effectiveness of surgical treatment in patients treated~     for infertility, but only a few reporting the results of varicocelectomy done for pain. This~     study attempted to examine the success rate of varicocele ligation when performed for the~     treatment of pain and to evaluate all the predictor factors that may affect the pain resolve~   "
126852|NCT01395173|"~     The purpose of this study is to determine whether position changes during colonoscope~     withdrawal affects polyp detection rate. We hypothesize that positions change during scope~     withdrawal will increase polyp detection rate.~   "
126853|NCT01395160|"~     The Female Experiences and Brain Activity study will investigate how different groups of~     people process information in different ways. Using electro-physiological methods it will~     investigate differences in brain activity between women with ADHD, women with bipolar~     disorder and those without a psychiatric illness. It will also investigate the relationship~     between patterns of brain activity, mood and functioning.~   "
126854|NCT01395147|"~     The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants~     with major depressive disorder after completion of an 8-week double-blind treatment period~     in a preceding study (Lu AA21004/CCT-003; NCT01355081).~   "
126855|NCT01395134|"~     Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy~     results in lowered fundamental frequency of the voice and worsened voice performance in~     producing high-frequency sounds. It remains unclear if use of intraoperative nerve~     monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved~     individual voice performance. This study was designed to test that hypothesis.~   "
126856|NCT01395121|"~     The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the~     treatment of patients with a rare group of acral and mucosal melanomas that have a change~     (mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with~     this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas~     are found on the palms and soles and mucosal melanomas start inside body cavities rather~     than on the skin.~   "
126857|NCT01395108|"~     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in~     healthy Chinese volunteers.~   "
126858|NCT01395095|"~     The objective is to investigate whether in acute coronary syndrome patients the cardiac risk~     profile will improve with 2 new extended cardiac rehabilitation interventions and if these~     patients maintain healthier life style habits and a more active life style compared to~     patients randomized to standard cardiac rehabilitation.~   "
126859|NCT01395082|"~     The purpose of this registry is to study the natural history of vaccination-related~     myocarditis and pericarditis and to assess possible risk factors for these conditions.~      Primary Objective:~      - To document the natural history of confirmed, probable, suspected, and subclinical~     myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.~      Other Pre-defined Objective:~      - To look for potential predictive factors for the prognosis of myopericarditis following~     ACAM2000® vaccination.~   "
126860|NCT01395069|"~     Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing~     macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and~     randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular~     coherence tomography (OCT).~   "
126861|NCT01395056|"~     To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin~     chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced~     killer cells in triple negative metastatic breast cancer patients~   "
126862|NCT01395043|"~     Major abdominal surgery is associated with postoperative pain. Transversus Abdominis~     Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal~     surgery. However a single block has a short effect of up to 12 hours depending on the type~     local-anesthetics used.~      With this study we wish to investigate the possibilities to place a TAP-catheter in order to~     prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP~     catheter and to study the pain and the opioid requirements of patients undergoing elective~     colon-resection when given a TAP-catheter preoperatively.~      Our hypothesis is that it is practical and technical possible to place bilateral~     TAP-catheters pre-operatively and that pain and opioid-requirements will be low.~   "
126929|NCT01394172|"~     The purpose of this study is to quantify the tidal volume generated by the pressure release~     immediately following the application of pressure to the chest.~   "
126863|NCT01395030|"~     Altered choline phospholipid metabolism is a recently recognized hallmark of cancer and~     potential diagnostic and therapeutic target in a number of cancers, including hepatocellular~     carcinoma (HCC). The feasibility of detecting HCC on the basis of measuring the~     phosphorylation rate of choline in-vivo has been shown using positron emission~     tomography/computed tomography (PET/CT) and the investigational tracer compound [18F]~     fluorocholine (FCH). This Phase 2 study will evaluate the diagnostic performance of FCH~     PET/CT in patients undergoing surgical resection as treatment for HCC. Since the molecular~     signaling alterations leading to enhanced choline metabolism in tumors are not fully~     elucidated at this time, this study will also collect frozen tissue specimens for~     whole-genome gene expression profiling to elucidate genes and signal transduction pathways~     related to altered choline metabolism in HCC.~   "
126864|NCT01395017|"~     The purpose of this study is to determine whether patients with locally advanced pancreatic~     cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared~     to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.~   "
126865|NCT01395004|"~     The purpose of this study is to assess safety and efficacy at months 3 and 6 in patients~     with Langerhans Cell Histiocytosis given daily oral doses of GSK2110183.~   "
126866|NCT01394991|"~     The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer~     who have chemotherapy-related anemia.~   "
126867|NCT01394978|"~     The purpose of this post approval study is to further characterize the safety profile of the~     ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term~     safety over 90 days of follow-up.~   "
126868|NCT01394965|"~     The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging~     methodology for localizing and imaging cardiac electrical activity from body surface~     electrocardiographic recordings in patients with ventricular tachycardia (VT). Using~     non-invasive means will increase our ability to correctly diagnose cardiac abnormalities,~     and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently~     exists.~   "
126869|NCT01394952|"~     The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular~     events and other serious outcomes in persons with type 2 diabetes, when added to their~     anti-hyperglycemic regimen.~   "
126870|NCT01394939|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594~     (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in~     colorectal carcinoma patients who are refractory to or intolerant to standard therapy.~   "
126871|NCT01394926|"~     The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15~     mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid~     arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.~   "
126872|NCT01394913|"~     This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT®~     versus ENBREL®) for treatment of Rheumatoid Arthritis.~   "
126873|NCT01394900|"~     The study has the following primary aims: (1) to test whether participants assigned to CNU~     (a 7-session, manualized intervention entitled Connect 'n Unite) engage in lower HIV/STI~     behavioral risk compared to participants assigned to WP (a wellness promotion attention~     control condition); (2) to test whether participants assigned to CNU have lower cumulative~     incidence of STIs—chlamydia and gonorrhea—confirmed via biological assay compared to~     participants assigned to WP; and (3) to test whether participants assigned to CNU engage in~     less drug use compared to participants assigned to WP.~   "
126874|NCT01394887|"~     Hypothesis. To determine the effect of metformin on the concentrations of resistin and other~     insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight,~     HbA1c, among others) in minors with glucose intolerance.~      Children with glucose intolerance are given either metformin or placebo for 12 consecutive~     weeks.~      High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin,~     adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the~     beginning and at the end of the period. Statistical analysis: t Student test; Friedman and~     Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and~     percentage weight change.~   "
126875|NCT01394874|"~     The purpose of this intervention is to determine whether computer-based telephone counseling~     will improve adherence to strength training in a population of elders with knee~     osteoarthritis.~   "
126876|NCT01394861|"~     The purpose of this study is to evaluate the feasibility, ease and safety of flexible~     endoscopic robotic system to treat early gastric cancer in humans.~   "
126877|NCT01394848|"~     Thanks to rapid reendothelialization derived from the pro-healing property of the EPC~     capture stent, 1-month dual antiplatelet therapy (DAPT) is recommended after EPC capture~     stent implantation. Shorter maintenance of dual antiplatelet therapy might minimize the risk~     for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent~     wasteful medications and bleeding complications related with dual antiplatelet therapy.~     Thus, the EPC capture stent might be valuable for the elderly because they are vulnerable to~     premature discontinuation of DAPT.~      On the other hand, statin upstream therapy has gained popularity because it seems to reduce~     periprocedural myocardial injury especially in ACS through its pleiotrophic effect like~     plaque stabilization. However, the benefit of pretreatment of statin in patients with stable~     angina remains controversial. It is reported that statin administration could increase EPC~     level by accelerated differentiation towards the endothelial progenitor lineage.~      We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is~     non-inferior to DES in the elderly subjects with stable coronary artery disease. To test~     this hypothesis, we will perform a multi-center, randomized, prospective trial aimed at~     demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES~     with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in~     real world practice.~   "
126895|NCT01394614|"~     The goal of the study is to assess the risk of occurrence of narcolepsy following the~     administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the~     province of Quebec, Canada, using different case definitions and time intervals to disease~     onset, while controlling for potential confounding variables such as age, gender, season~     and, when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the~     epidemiology and clinical features of narcolepsy cases with onset during the period January~     1st, 2009 to December 31, 2010 in the population of Quebec.~   "
126878|NCT01394835|"~     Bronchiolitis obliterable syndrome (BOS) is the most common cause of death in long-term~     survivors after lung transplantation and refractory to most interventions. Many risk factor~     for BOS were identified in previous studies such as acute cellular rejection, lymphocytic~     bronchiolitis, cytomegalovirus (CMV) and non-CMV respiratory infections, injury to the~     allograft or airways, Primary graft dysfunction, HLA mismatching, and organizing pneumonia.~     (Belperio JA. et al.). Neutrophils and their released products may be involved in the~     development of BOS. Neutrophilia was repeatedly observed in the bronchoalveolar lavage fluid~     of patients after lung transplantation. In addition, infiltration of neutrophils into the~     bronchial epithelium has been detected in patients with higher degrees of active airway~     damage. Neutrophils are capable of causing severe damage to the lung tissue by releasing~     toxic proteases and reactive oxygen species if not counterbalanced by the antiprotease/~     antioxidant screen of the lung. Based on this background, a causal relationship between~     neutrophilia and the development of BOS has been proposed. (Hirsch J. et al.) Detection of~     unopposed Neutrophile elastase (NE) activity in BAL appears to correlate with poor outcome~     due to refractory BOS. Unopposed NE in these subjects may not only serve as a marker of~     evolving graft dysfunction but also participate in damaging the airways of the allograft and~     inhibit adequate bacterial clearance. Prevention of neutrophil sequestration or inhibition~     of NE may prevent or attenuate airway damage and improve bacterial clearance mechanisms.~     (Nutley D et al.) These data demonstrate the importance of neutrophils and unopposed NE in~     the pathogenesis of BOS and call for new approach to prevent or modulate BOS targeting this~     mechanism.~      AAT is the main inhibitor of neutrophil elastase in the lower airways and patients with AAT~     deficiency have low concentrations of the protein in this region of the lung. This explains~     the proteinase/antiproteinase theory of the development of emphysema in deficient patients~     in which the amount of elastase released in the lung exceeds the amount of AAT. The net~     result is persistence of elastase activity leading to lung destruction and the pathological~     changes of emphysema. (Abusriwil H. et al.) The administration of the AAT is to address~     proteinase/antiproteinase imbalance.~      Administration of AAT will help to prevent further destruction of the lung architecture and~     reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that~     by attacking a specific and previously untreated key component part of the~     pathophysiological cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung~     transplant recipients and prolong life expectancy of these patients.~   "
126879|NCT01394822|"~     The purpose of this study is to determine if a new diagnostic technique, called~     neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.~   "
126880|NCT01394809|"~     The therapy results after distal radius fracture especially of elderly patients are often~     suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which~     leads to reduction in ROM of the wrist, deterioration of muscle strength as well as~     malfunction of fine motor skills and coordination. Currently, there are no adequate~     proactive strategies to counteract these immobilisation problems. Hence the overall aim of~     our research project is to investigate the therapeutic potential of a motor-cognitive~     therapy on hand function after distal radius fracture. On the one hand the pilot study~     should provide information about the level of recruitment rate necessitated for an adequate~     sample size which allows reliable evidence for the therapy effects. On the other hand we~     want to evaluate the sensitivity and adequacy of the assessment instruments.~      The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6~     weeks with 3 groups. One experimental group imagine movements and actions without executing~     them. A second experimental group performs mirror training, in which visual feedback through~     a mirror activates additionally the contralateral hemisphere. The control group receives~     therapy as usual. There are three key domains to be analysed: function (PRWE), impairment~     (ROM, strength) and participation in social life/life quality (DASH, EQ5D).~   "
126881|NCT01394796|"~     There is a mounting evidence of the modulation properties of the major catechin in green~     tea, epigallocatechin-3-gallate (EGCG), on dual specificity~     tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) gene overexpression in the brains of~     DS mouse models.The aims are to investigate the clinical benefits and safety of EGCG~     administration in young adults with DS, to establish short-term EGCG effects (three months)~     on neurocognitive performance, and to determine the persistency or reversibility of EGCG~     related effects after three months of discontinued use.~   "
126882|NCT01394783|"~     Every year thousands of neonates born in North America need extensive resuscitation which~     often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the~     role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI~     procedure. They acquire this skill during residency training in the Neonatal Intensive Care~     Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small~     size of the mouth and airway of the neonate, and their particular anatomy of the larynx.~     This limited visibility represents a challenge even for the experienced clinician. Recently,~     a new videolaryngoscope (VL) technique has been introduced to the adult and pediatric~     medical fields as described respectively by Kaplan et al. and Weiss et al. In 2009,~     Vanderhal et al. reported a preliminary experience in the newborn population. Video assisted~     intubation could be a method of choice in teaching neonatal ETI.~      To the best of our knowledge, there is no human study comparing the VL to the classic~     laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.~      This study aims:~        1. To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring~          the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and~        2. To assess if once the skill is acquired with the videolaryngoscope this experience is~          transferable to the use of the classic laryngoscope by showing a persistent difference~          in success rate in favor of the videolaryngoscope group.~      The hypothesis are~        1. Primary hypothesis:~           In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success~          rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later,~          acquired experience from the videolaryngoscope will be transferable to the use of the~          classic laryngoscope by showing a persistent difference in success rate of 20% in favor~          of the videolaryngoscope group.~        2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to~          intubation, and decrease rate of esophageal and right bronchial main stem intubations.~          It will also improve teaching of endotracheal intubations to pediatric residents by~          helping supervisors recognize problems related to intubation and by improving~          residents' level of confidence in performing the skill.~   "
126883|NCT01394770|"~     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study~     was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with~     amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these~     high-risk patients.~   "
126884|NCT01394757|"~     Alterations of functional brain networks have been frequently demonstrated in schizophrenia,~     although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to~     exert its schizophrenia-like effects through modulation of the glutamatergic system, thus~     facilitating the investigation of the impact of this specific transmitter system on resting~     state functional brain networks. The aim of the study is therefore to use pharmacological~     functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved~     in schizophrenia in response to ketamine application compared to placebo. 30 healthy~     subjects (15 females) will be examined twice using a double-blind, placebo-controlled,~     randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated~     before, during and after either placebo or ketamine intravenous infusion for 20 minutes.~     Prior to the main trial 10 additional participants will be included in an open pilot trial.~      Hypothesis: Ketamine application will induce changes in resting state networks previously~     associated with schizophrenia and in the connectivity of relevant brain regions such as the~     striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of~     ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed~     before and after ketamine infusion.~   "
126938|NCT01394055|"~     The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK)~     profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and~     delayed gastric emptying.~   "
126885|NCT01394744|"~     The goal of the study is the analysis of metal ion serum concentrations and of the cytokine~     production in the blood of patients with a conventional cementless total hip replacement.~     The rationale is that a) the bearing wear releases particles respectively metal ions into~     the joint and the blood which will differ in quantity and composition; b) the cytokine~     production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying~     degree by the metal and the ceramic particles.~      The patients from whom the respective samples will be analyzed are randomized in one of the~     following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm~     bearing is used in all patients. In this separate study, follow-up data of the clinical and~     radiographic examinations of the patients are available.~   "
126886|NCT01394731|"~     The purpose of this study is to determine whether intravenous paracetamol is effective in~     treating labor pain.~   "
126887|NCT01394718|"~     This is a prospective, randomized, double-blinded, placebo controlled trial Potential~     subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal~     guardians will be approached about study participation at the Anesthesia outpatient~     pre-visit. Attending Anesthesiologist will receive e-mail notification about potential~     subject participation the day before the scheduled surgery. Study lab (hepatic function~     panel) will be collected as soon as possible after anesthesia induction by anesthesia.~     Results will be reviewed by study team member and study drug will be ordered by study team~     if patient does not meet exclusion criteria. Study drug (IV acetaminophen or placebo) will~     be administered at the time of skin closure by anesthesia on completion of the surgical~     procedure (after randomization). Study drug will be administered every 6 hours for 2 days.~     Subjects will continue to receive standard of care with patient controlled analgesia (PCA)~     opiate therapy (morphine or hydromorphone) for analgesia as per the Pain Management Service.~     Pain scores, opiate (morphine equivalent) administered, requirements for treatment of opiate~     related side effects (treatment for nausea and itching), and certain post-operative~     characteristics will be measured for up to 4 days post-operatively (time to mobilization,~     time to diet advancement, time to discharge).~   "
126888|NCT01394705|"~     This pilot study seeks to compare the change in energy expenditure and fitness levels of~     patients seen in the Children's Hospital Preventive Cardiology program receiving standard of~     care provider exercise counseling to similar patients receiving Frequency, Intensity, Time,~     Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an~     online interactive tool.~      The investigators primary hypothesis is that this interactive technology coupled with~     support from a exercise specialist will increase the energy expenditure of the investigators~     patients over standard of care provider counseling.~      The investigators Secondary hypotheses include greater improvement in measured physical~     fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold~     (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure,~     arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the~     intervention group compared to control.~   "
126889|NCT01394692|"~     Excision to the maximum possible extent marks the first step of glioma surgery. Depending on~     tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre~     studies have shown that the presence of residual tumour according to MRI-criteria is a~     prognostic factor in this incurable condition.~      In order to improve the extent of resection, several methods, in particular intraoperative~     imaging techniques, have become available to demonstrate already during surgery whether the~     goal of surgery has been achieved. The intraoperative MRI devices currently available differ~     in their magnetic field strengths and image resolution, but also in their amount of~     interference with the surgical workflow.~      Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma~     surgery are lacking. To assess whether the rate of radiologically complete tumour resections~     can be improved by using intraoperative MRI-guidance, we designed this prospective,~     randomized trial. We hypothesized that the extent of resection that can be achieved using an~     intraoperative MRI is greater than that of conventional microsurgical tumor resection.~   "
126890|NCT01394679|"~     The purpose of this study is to determine if the images of the primary lesions of lung~     cancer and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans~     are the same as the PET/CT 18F-FDG scans.~   "
126891|NCT01394666|"~     The purpose of this study is to evaluate treatment patterns and associated outcomes for~     CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.~   "
126892|NCT01394653|"~     A study to compare time-course changes of plasma concentration of YM060~     orally-disintegrating tablet with those of conventional tablet. Tablets will be administered~     with water.~   "
126893|NCT01394640|"~     Primary objective~      1) To assess whether oncologic and hematologic patients develop a protective immunological~     response after pandemic Influenza A (H1N1) vaccine~      Secondary objectives~        1. To compare the levels of antibody response against A (H1N1) influenza virus between~          oncologic and hematologic patients relative to a cohort of healthy volunteers~        2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic~          patients in comparison with a cohort of vaccinated healthy volunteers. To assess the~          clinical symptoms attributable to influenza infection in vaccinated oncologic and~          hematological patients and healthy volunteers.~        3. To compare the levels of antibody response against A (H1N1) influenza virus between the~          following subgroups: patients with ongoing chemotherapy; patients who have completed~          the chemotherapy treatment; patients treated with autologous or allogeneic peripheral~          blood hematopoietic stem cell transplant (PBSCT)~      Study procedures: Onco-hematological patients will perform a blood sample collection before~     the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the~     collection, the investigators will perform immunological test to evaluate the antibody titer~     and the cellular response. The titer of antibodies against the vaccine strain will be~     measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey~     erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of~     a protective title of HI test > 1:40. In addition, the investigators will evaluate:~     geometric mean titers and a fourfold titer increase compared with prevaccination titers.~     Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy~     volunteers who received A(H1N1) vaccine will perform the same blood sample collection.~      Evaluation of clinical response: Oncologic and hematologic patients will be followed as~     outpatients or inpatients according to routine controls for their disease. In case that~     symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be~     recorded in the clinical database, nasal and pharyngeal swaps will be performed according to~     the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of~     the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further~     studies will be performed after 3 months from the vaccination.~   "
126894|NCT01394627|"~     The purpose of this study is to look at whether blockade of the mineralocorticoid receptor~     will result in changes in the cardiovascular and inflammatory response to hypoglycemia. We~     are also looking at the effect of hypoglycemia on fMRI.~   "
126939|NCT01394042|"~     This is a small study to determine if probe, similar to an ultrasound probe, can detect~     prostate cancer more specifically than other imaging studies in patients with a positive~     prostate cancer biopsy.~   "
126940|NCT01394029|"~     This study will observe patients with transfusional hemosiderosis treated with deferasirox~     in actual practice setting.~   "
126896|NCT01394601|"~     RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients~     who are hospitalized due to an acutely agitated psychotic episode. The patients should be~     managed according to normal clinical practice until discharge time. Data will be collected~     by review of medical records of the hospitalisation prior the study visit. During the study~     the patients will conduct one visit on the day of their discharge after hospitalisation due~     to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis~     and medical history will be recorded. Data on antipsychotic and concomitant medication will~     be collected by review of medical records.~   "
126897|NCT01394588|"~     This is an observational study of continuous glucose monitoring technology during cardiac~     surgery. The investigators would like to develop data for descriptive analysis of a~     comparison of continuous glucose monitoring with a gold standard under the conditions of~     cardiac surgery.~   "
126898|NCT01394575|"~     This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma~     in situ treated by breast conserving surgery, postoperative whole breast irradiation with~     inversely intensity modulated radiotherapy and a simultaneous integrated boost is~     technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic~     outcome and local control rate in a single center~   "
126899|NCT01394562|"~     The purpose of this study is to confirm that treatment with IV ferric carboxymaltose~     improves exercise capacity, physical functioning and quality of life in patients with iron~     deficiency and chronic heart failure.~   "
126900|NCT01394549|"~     Despite efforts of learned societies, community cardiology and more generally of most~     players in the health, cardiovascular diseases continue to be the leading cause of death~     among women in France and all over the Western world, there where they fell to second place~     among men. Clinical practice and the disparity between the sexes are still insufficiently~     known.~      Multicenter observational study on a cross-week comparative basis with men~   "
126901|NCT01394536|"~     Postoperative nausea and vomiting after outpatient surgery are significant sources of~     patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should~     be equally as important as prevention of pain because both are large sources of patient~     dissatisfaction and can necessitate admission after routine outpatient procedures.~      None of the currently available pharmacological interventions are able to totally abolish~     PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has~     yet to be studied when the patient takes the device home with them after leaving an~     outpatient facility.~   "
126902|NCT01394523|"~     The literature has clearly demonstrated that the effective treatment of postoperative pain~     in infants and children is challenging. In an effort to improve postoperative analgesia~     while limiting opioid-related adverse effects, there continues to be an increased use of~     regional anesthetic techniques in infants and children. Although the pediatric caudal~     remains the most commonly used pediatric regional anesthetic technique, it has been~     demonstrated that effective analgesia can be provided with the use of peripheral nerve~     blockade even in the pediatric-aged patient. The purpose of this study is to prospectively~     compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair~     who have received either a caudal block or bilateral rectus sheath blocks for analgesia~   "
126903|NCT01394510|"~     Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a~     critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell~     dysfunction with oxidative stress proposed as a major mediator of this glucotoxic effect.~     High glucose levels have also been shown to contribute to vascular dysfunction and~     inflammation and these adverse responses decreased with the use of antioxidants. The~     hypothesis is that antioxidants improve beta-cell function in individuals with elevated~     glucose levels by decreasing oxidative stress. In this study the investigators will~     specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell~     function in individuals with type 2 diabetes by decreasing oxidative stress.~      This study will be a dose finding study to determine the tolerability of 600 mg versus 1200~     mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative~     stress markers in persons with type 2 diabetes.~   "
126904|NCT01394497|"~     Randomized prospective study on the impact on the post-LT outcome by the infusion of~     N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to~     reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).~   "
126905|NCT01394484|"~     Does the consumption of dairy foods reduce the rate of bone loss in older women more than~     calcium and vitamin D supplements.~   "
126906|NCT01394471|"~     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves~     social cognition, psychotic symptoms and social functioning in schizophrenia.~      Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one~     year.~      Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal~     spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo~     psychiatric symptom ratings and tests of mental abilities used in social functioning,~     cognition, and social competence.~   "
126907|NCT01394458|"~     Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are~     locked into hemodialysis catheters between dialysis sessions to prevent thrombosis. The~     use of an ethanol/sodium citrate locking solution may have advantages over either of these~     agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter~     locking solution is safe and effective in the prevention of catheter-related infections and~     thrombosis.~   "
126908|NCT01394445|"~     The investigators hypothesize that the administration of physostigmine in the postoperative~     period after nephrectomy reduces opioid consumption.~   "
126909|NCT01394432|"~     The investigators hypothesised that endocardial stem cells implantation following after~     percutaneous coronary intervention (PCI) could reduce the scar formation and increase~     reverse remodeling in patients with primary acute myocardial infarction.~   "
126910|NCT01394419|"~     N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump~     coronary artery bypass graft.~   "
126911|NCT01394406|"~     Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of~     postoperative nausea and vomiting by reducing opioid requirement after surgery.~   "
126912|NCT01394393|"~     Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in~     México City, Mexico. Informed consent to participate will be aleatory assigned to a three~     different conditions.~      Procedures In the initial interview, prospective participants will be provided with detailed~     information about the study and the treatments. All patients included in the study will be~     randomly assigned to the one (N=20) of the three treatment conditions described below, all~     conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be~     administered by two chartered clinical psychologists and one chartered psychotherapist under~     the supervision of a senior chartered psychotherapist. The three therapists will be balanced~     among the three conditions.~        1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5~          weekly nutritional groups held by dieticians based on the LEARN manual (Brownell,~          1985), whose goal will be to provide practical guidelines for the self-monitoring of~          eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric~          restriction achieved largely by reductions in fat intake), plus a low-calorie diet~          (1,200 kcal/day) and physical training (30 min of walking two times a week as a~          minimum).~        2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment~          proposed in the first condition plus 15 additional sessions over 6 weeks.~           Therapists will follow a detailed manual that outlined the content of each session.~          This manual was based on the cognitive—behavioral treatment approach described by~          Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed~          during a year of intensive pilot work and adapted to the in-patient setting. Patients~          will be taught to self-monitor their food intake and eating patterns and thoughts, as~          well as the circumstances and environment surrounding eating (e.g. whether eating alone~          or with others, speed of eating, and place of eating). Patients will also be taught to~          identify problems in eating, mood, and thinking patterns and to gradually develop~          alternative patterns.~           In particular, after the first week the patients will enter 5 weekly group sessions~          aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed~          at establishing and maintaining weight loss, addressing barriers to weight loss,~          increasing activity, addressing body image concerns and supporting weight maintenance.~        3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment~          proposed in the first condition plus 15 additional sessions over 4/6 weeks.~      In the sessions we will use the 20/20/20 rule. During the first 20 minutes, the therapist~     focus on getting a clear understanding of the patient's current concerns, level of general~     functioning, and the experiences related to food. This part of the session tends to be~     characterized by patients doing most of the talking, although therapist guides with~     questions and reflection to get a sense of the patient's current status. The second 20~     minutes is devoted to the virtual reality experience. During this part of the session the~     patient enters the virtual environment and faces a specific critical situation (Kitchen,~     Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing~     specific strategies for avoiding and/or coping with it. In the final 20 minutes the~     therapist explores the patient's understanding of what happened in VR and the specific~     reactions - emotional and behavioral - to the different situations experienced. If needed,~     some new strategies for coping with the VR situations are presented and discussed. To~     support the empowerment process, the therapists follow the Socratic style: they use a series~     of questions, related to the contents of the virtual environment, to help clients synthesize~     information and reach conclusions on their own.~      In accordance with informed consent, assessments will be obtained before treatment, at~     posttreatment, 3 and 6 months after the treatment conclusion.~   "
126913|NCT01394380|"~     The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can~     soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks,~     subjects will be randomized to either a 12-week intervention arm in which sweetened~     beverages will be replaced by artificially sweetened, calorie-free beverages, or to a~     control arm. The following measurements will be performed at the end of the run-in period~     and at the end of the intervention period~        -  intrahepatic fat concentration~        -  visceral fat volume~        -  changes in day-long metabolic profile from baseline(plasma glucose, insulin, and~          triglyceride concentrations)~        -  changes in food intake and daily energy, carbohydrate and sugars intake from baseline~   "
126914|NCT01394367|"~     Aim of this study is to investigate whether and to what extent a cautious respiratory and~     exercise therapy can complement medical treatment and change the condition, oxygen uptake,~     quality of life, the pulmonary vascular pressures, the size of the right heart and the~     6-minute walk distance in patients with pulmonary hypertension.~   "
126915|NCT01394354|"~     Primary objective of the study is the determination of the maximum tolerated dose (MTD) of~     Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and~     Dexamethasone (D).~      Secondary objectives are:~      Assessment of safety and tolerability of VBDD; efficacy data of VBDD.~   "
126916|NCT01394341|"~     Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is~     new and fundamentally different from the classical treatments with oral antidiabetic agents~     and insulin. The novel and original aspect of this investigator-initiated study is the focus~     on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients~     with severely reduced kidney function. At present there is virtually no knowledge of the~     physiology and clinical implications of the role of incretin hormones and incretin-based~     therapy in this group of diabetic patients.The aim of the study is to establish an~     evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of~     antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall~     hypothesis is that patients with T2D and severe renal insufficiency will tolerate and~     benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic~     control and reducing risk factors of cardiovascular disease~   "
126917|NCT01394328|"~     The aims of this study were to identify risk factors associated with delirium in~     hospitalized persons with dementia, and to describe immediate and post-hospital (1&3 months)~     trajectory of cognitive decline and associated outcomes in persons with dementia who develop~     delirium. It was hypothesized that factors such as CNS-active medications, urinary tract~     infection, stage of dementia, pain, activity level, and dehydration would be associated with~     an increased risk of delirium and delirium severity in patients with dementia compared to~     dementia patients without delirium. It was also hypothesized that persons with DSD will have~     worse outcomes (longer hospital length of stays, decreased functional status, a steeper~     negative slope of cognitive decline) than dementia patients without delirium. Lastly, it was~     hypothesized that higher delirium severity would be associated with poorer outcomes in~     persons with dementia. The long-term objectives were to use the results from this study to~     design and test an intervention strategy to improve early recognition, management,~     prevention, and outcomes in persons with DSD.~   "
126918|NCT01394315|"~     The aim of the study is to determine if DOT can detect response early in breast cancer~     patients undergoing neoadjuvant chemotherapy.~   "
126919|NCT01394302|"~     The purpose of this study is to Characterize the population of people who suffer from~     trigger finger (TF) in terms of demographic (Gender, age, occupation, etc.); motor skills~     (hand function); the Consequences of the disease on a person's daily functioning and impact~     on quality of life.~      The study will also attempt to examine the suitability of several common assessment tool for~     evaluation of hand rehabilitation Patients who suffer from TF.~      Information obtained from the study will enable a deeper comprehension of the consequences~     of TF on the patient and will be the first step in developing a protocol assessment and~     evidence-based treatment in this population.~   "
126920|NCT01394289|"~     The objective of this study is to determine the biologic activity of a Lolium perenne~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
126921|NCT01394276|"~     This observational study will evaluate the efficacy and safety of RoActemra/Actemra~     (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis.~     Data will be collected from patients for the 12 months following the first infusion of~     RoActemra/Actemra.~   "
126922|NCT01394263|"~     This trial was an open-label, multi-national, randomized, parallel treatment, active-control~     multicenter study in adult males with documented metastatic prostate cancer disease who were~     judged to be candidates for hormone therapy.~   "
126923|NCT01394250|"~     The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable~     device that provides cold and vibration, in reducing the pain associated with intravenous~     (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical~     lidocaine cream in reducing the pain associated with IV cannulation.~   "
126924|NCT01394237|"~     The purpose of this study is to determine the long term results of laparoscopic~     sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries~     required, patients satisfaction and quality of life.~   "
126925|NCT01394224|"~     The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the~     bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg~     and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.~   "
126926|NCT01394211|"~     This phase II trial studies how well giving pazopanib hydrochloride and anastrozole before~     surgery works in treating patients with stage II-III estrogen receptor-positive breast~     cancer. Pazopanib hydrochloride and anastrozole may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride and~     anastrozole together before surgery may make the tumor smaller and reduce the amount of~     normal cells that have to be removed~   "
126927|NCT01394198|"~     The purpose of this study is to correlate the link between palpatory findings of somatic~     dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. The~     investigators' hypothesis is that there is a direct connection between somatic palpatory~     changes and intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.~   "
126930|NCT01394159|"~     The aim of this research study is to identify the best needle for performing biopsy during~     EUS procedures. There are two types of needles for performing biopsy: A FNA needle that~     provides a small sample of tissue for analysis and a ProCore needle that provides larger~     amount of tissue. It is not clear at this point which of the two needles is superior for~     performing biopsy. This study will attempt to identify the better needle by assessing the~     performance of both needles in a randomized fashion.~   "
126931|NCT01394146|"~     The purpose of the study is to learn more about how phosphorus-based food additives affect~     phosphorus metabolism in people with normal kidney function.~   "
126932|NCT01394133|"~     Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have~     higher amounts of drugs in their body compared with men taking the same dose of anti-HIV~     drugs. The reason for this higher drug exposure has not yet been determined. The primary~     purpose of this study is to examine whether a pharmacokinetics (factors that determine the~     amount of drug in the body) of anti-HIV drugs change during different phases of the~     menstrual cycle in women and ultimately result in higher amounts of drug in the body~     compared with men. In other words, we plan to examine whether changes in sex hormones~     throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women.~     The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.~   "
126933|NCT01394120|"~     In recent years, treatment of advanced pancreatic cancer is changing. Currently, there are~     several active schedules of chemotherapy that can be used, such as gemcitabine as~     monotherapy or in combination with capecitabine or erlotinib, and FOLFIRINOX. Moreover, the~     development of biomarker (therapeutic targets) that can predicte response to treatment is a~     new important tool to be used in clinical practice to select the best scheme for each~     patient. Preliminary studies showed that therapeutic target determination, using tumor~     tissue collected from patients, could determine the presence of groups of chemotherapy~     responders. Such is the case of EGFR amplification and/or K-Ras gene status and correlation~     with response to erlotinib. Moreover, Thymidilate Synthase, Thimidine Phosphorylase, ERCC-1~     and Topoisomerase I expression by immunohistochemistry in GI tumor samples has been related~     to resistance or response to 5FU-capecitabine, oxaliplatin and irinotecan respectively.~     Based on this data the investigators designed a phase II clinical trial to evaluate the~     efficacy of selected treatment for pancreatic cancer patients based on the determination of~     therapeutic targets. The therapeutic target-driven treatment efficacy will be compared to~     the prospective treatment of a control group of patients treated at the discretion of the~     physician-researcher~   "
126934|NCT01394107|"~     The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation~     in pregnant women just before birth, at the period of maximal physiological hypercoagulable~     state and with high risk of thromboembolism, the most common cause of maternal mortality in~     developed countries. Although LMWH are now routinely administered as prevention of~     thromboembolism, their effect on coagulation in pregnant women was not yet studied. The~     doses of LMWH in pregnancy are only derived in terms of coagulation from totally different~     groups of patients (surgical, orthopedic). We therefore will map the effect of~     thromboprophylactic LMWH dose on coagulation in pregnant women using recently available~     methods, especially a complex examination of coagulation within 24 h after LMWH application~     using thrombelastography, including examination with heparinase, and monitoring the effect~     of LMWH by measuring antiXa and TGT (thrombin generation time) activity. Based on these~     results we will also evaluate the possible influence of LMWH prophylaxis on the risk of~     spinal haematoma during neuraxial analgesia/anesthesia for delivery/Caesarean section. On~     the basis of our pilot results we can presume the current dosage of LMWH in pregnant women~     is inadequate and that it would be appropriate to adjust presently used dosage. At the same~     time we want to prove that the standard LMWH thromboprophylaxis in pregnant women does not~     increase the risk of spinal haematoma during neuraxial blockade. In both situations the~     targeted outcome is to increase the safety of pregnant women.~   "
126935|NCT01394094|"~     Gum chewing can promotes the return bowel function after gynecologic surgery.~   "
126936|NCT01394081|"~     The purpose of the Alabama Veterans Rural Health Initiative is to better understand access~     and barriers to health care and to enhance veteran enrollment or engagement in health care~     services of veterans residing in rural areas. It describes an intervention that is adaptable~     for use by other VA facilities that serve veterans in rural settings, and importantly, this~     study will improve our understanding of barriers to care and evaluate a method for enhancing~     access to care. The anticipated impact is that more veterans in rural areas who were~     previously under-utilizing VA services will receive and attend a health care appointment.~     This gain may improve preventative and primary care health care and reduce long term health~     care morbidity, expense and burden. This study may also identify previously unknown barriers~     to care that can be surmounted by innovative access and health care delivery approaches.~      The primary objective is to evaluate an innovative approach for enhanced enrollment or~     engagement intervention (EEE intervention) for rural veterans in VA health care services.~     Phase I entails a two-cell design, addressing this objective with a prospective, randomized~     controlled multi-site clinical trial that evaluates an active intervention compared to a~     control treatment as usual (TAU)condition on whether or not a rurally-residing veteran~     obtains and attends a VA appointment. Phase II encompasses a three-cell design, addressing~     the above mentioned objective with a randomized controlled, multi-site clinical trial that~     evaluates two active interventions compared to a control intervention.~   "
126937|NCT01394068|"~     In this observational study the effect of selenium supplementation on the postoperative~     inflammatory response and clinical course should be examined in (approximately 100) adult~     patients undergoing elective heart surgery combined with extracorporeal circulation.~      Selenium is one of the essential trace elements with a variety of important immunological~     and antioxidant properties. The pathophysiological relevance of different selenium-dependent~     reactions has already been demonstrated in human and in animal experiments. It is essential~     for the enzymatic functions of selenium-containing proteins such as the glutathione~     peroxidase, which in turn affects the leukotriene, thromboxane and prostacyclin metabolism.~     In addition, selenium has a significant influence on various liver enzymes, therefore~     selenium deficiency leads to oxidative or chemically induced liver damage.~   "
126941|NCT01394016|"~     The purpose of this study is to determine a safe dose of LY2835219 to be given to~     participants with advanced cancer and to determine any side effects that may be associated~     with LY2835219 in this population. Efficacy measures will be used to assess the activity of~     LY2835219 in this population.~   "
126942|NCT01394003|"~     The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that~     may be safely administered to patients with advanced/metastatic cancer.~   "
126943|NCT01393990|"~     The objective of this study is to determine a safe dose of LY2228820 that may be given to~     patients with advanced cancer. Part A of this study will consist of dose escalation, and~     Part B will consist of dose confirmation.~   "
126944|NCT01393977|"~     The morbidity of spinal cord injury (SCI) is increasing significantly in China. The methods~     to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation~     therapy is the routine method to treat SCI in sequela stage, its effect to improve the~     neurological disorders of these patients, such as the dysfunction of sense, motor,~     autologous adjustment of blood pressure control of urination and defecation, perspiration ,~     etc. is unsatisfying. Rehabilitation Therapy can prevent the process of muscle atrophy and~     joint stiffness. However, it can not repair the damaged nerve function. Studies show that~     mesenchymal stem cell transplantation can remarkably improve the neurological function of~     SCI in animals without any severe side effect.~      In this study, the investigators use mesenchymal stem cells derived from umbilical cord to~     treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The~     investigators also follow-up ten patients who only receive rehabilitation and another ten~     outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the~     investigators can compare the efficacy of these two treatments.~   "
126945|NCT01393964|"~     The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients~     with very low kidney function including patients on dialysis.~   "
126946|NCT01393951|"~     This trial is designed as a blinded, randomized and parallel group study to investigate the~     clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and~     safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in~     healthy adults.~   "
126947|NCT01393938|"~     Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated~     to be around 2% in the general population, and 6% to 7% in women with a history of recurrent~     pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra~     uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and~     pregnancy loss varies with the type of MDA. Patients can benefit from surgery or~     hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to~     optimize patient outcomes, accurate diagnosis and description of MDAs is essential.~      Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI,~     although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive.~     Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases~     MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a~     reference standard for uterine evaluation. In a study comparing MRI and endovaginal~     Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a~     sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.~      Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates~     three-dimensional volumes from a series of two-dimensional images. This technique allows the~     user to acquire coronal or face-on-view of the uterus which is essential in evaluating the~     uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and~     found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of~     100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7].~     Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy~     or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS~     appears to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is~     less expensive than MRI and in some patients better tolerated. If validated using~     prospective studies, 3DUS has the potential to become the reference standard for the~     diagnosis of MDAs.~   "
126948|NCT01393925|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted~     in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients~     aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general~     anesthesia will be involved in this study. According to previous studies and our pilot~     trial, the sample size was estimated to be 120 subjects. All eligible patients will be~     randomly assigned to one of three groups: Group A (single parecoxib) receiving parecoxib~     40mg at 30min before the end of surgery; Group B (multiple parecoxib) receiving parecoxib~     40mg at 30min before the end of surgery, at 8h and 20h after the surgery, respectively, and~     Group C (Control group) receiving normal saline. All patients will be managed by a standard~     propofol-remifentanil based total intravenous anesthesia protocol. The incidence and~     intensity of shoulder pain at rest and with motion will be evaluated by an independent~     doctor blinding to medication and grouping using visual analog scale (VAS) at 6h, 24h and~     48h postoperatively. Other types of pain (e.g. trocar wound and visceral pain), side effects~     (such as postoperative nausea and vomiting, itching, dizziness, and oversedation) will be~     assessed as well. At the end of the observation, the intensity of the maximum pain will be~     recorded, and the effect of shoulder pain on the four variables regarding to quality of life~     (activity, mood, walking and sleep) will be assessed using modified Brief Pain~     Inventory(BPI) questionnaire.~   "
126949|NCT01393912|"~     This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of~     Platelet Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with~     newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent,~     progressive or refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study~     drug targets the most commonly amplified region of genome found in DIPG and pediatric high~     grade glioma (HGG) which encodes for the PDGF receptor kinase. An oral investigational agent~     crenolanib will be administered daily during and after local radiation therapy (RT) in~     Diffuse Intrinsic Pontine Glioma DIPG (Stratum A), or daily for children with~     recurrent/refractory HGG (Stratum B).~   "
126950|NCT01393899|"~     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to~     severe Crohn's disease who completed the double-blind induction treatment in Study A3921083~     and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.~   "
126951|NCT01393886|"~     The aim of this study is to find out the safety and efficacy of Laparoscopic Greater~     Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive~     weight loss surgery that has the potential to reduce the complications associated with~     gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of~     an implant and without cutting stomach.~   "
126962|NCT01393743|"~     This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of~     perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and~     adults maintained on one to two stable antiepileptic drugs.~   "
126952|NCT01393873|"~     Studies conducted assessing diabetic eye disease have shown a progression of diabetic~     retinopathy with rapid improvement of glycemic control during pregnancy and in patients with~     type 1 diabetes. It is also well documented that bariatric surgery may result in rapid~     improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the~     progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been~     studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will~     examine the effects of rapid glycemic control which is seen in type 2 diabetics following~     bariatric surgery on the progression of diabetic retinopathy.~   "
126953|NCT01393860|"~     The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus~     of change in renal function following aliskiren initiation as well as to identify~     triggering events that lead to aliskiren initiation.~   "
126954|NCT01393847|"~     Background:~      - Sickle cell disease often causes crises, with episodes of pain. Many people with sickle~     cell disease also have pain between crises. Inflammation is an important part of sickle cell~     pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that~     helps relax blood vessels and may be related to the pain from sickle cell disease.~     Researchers want to study the relationship between blood levels of nitric oxide and pain in~     people with sickle cell disease. Researchers also want to study how certain genes express~     themselves related to sickle cell pain.~      Objectives:~      - To collect blood samples and other genetic expression information to study sickle cell~     pain and its relation to nitric oxide levels in the blood.~      Eligibility:~        -  People at least 18 years of age who have sickle cell disease.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study requires a screening visit and four study visits scheduled 1 week apart.~          Each visit will last about 1 hour.~        -  Participants will be screened with a medical history and physical exam. They will~          complete questionnaires about pain levels (if any). They will also provide blood~          samples for genetic and other testing.~        -  Participants will have a breath test to see how much nitric oxide they exhale. They~          will also have a test of their ability to detect small changes in temperature and~          touch.~        -  Participants will keep a diary to record daily pain levels and pain medicines taken.~          They will write down what they eat to track foods that contain nitrates (such as meats~          like ham and bacon and vegetables like beets and spinach).~        -  At each of the four study visit, participants will bring the pain diary, provide blood~          samples, and have breath nitric oxide tests.~   "
126955|NCT01393834|"~     This study is being done to evaluate if delaying cord clamping or milking the umbilical cord~     of the preterm infant has health benefits for the baby. Timing of clamping of the cord~     varies among doctors, but there is information that shows that delaying clamping of the~     umbilical cord in premature infants may reduce the rate of the baby needing a blood~     transfusion, decrease the risk of infection and bleeding in the head.~   "
126956|NCT01393821|"~     This clinical trial studies menadione topical lotion in treating skin discomfort and~     psychological distress in patients with cancer receiving panitumumab, erlotinib~     hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin~     discomfort and help alleviate psychological distress and pain in patients receiving~     treatment with panitumumab, erlotinib hydrochloride, or cetuximab~   "
126957|NCT01393808|"~     Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for~     renal disease progression. More proteinuria is associated with faster progression, whereas~     treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic~     chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower~     is the disease progression in the long term. On the basis of the above findings, proteinuria~     has become a target of renoprotective therapy.~      Among different antihypertensive medications, those that inhibit the Renin Angiotensin~     System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor~     blockers (ARBs), are those that at comparable blood pressure control, more effectively~     reduce proteinuria and slow renal disease progression. Thus they have become the key~     component of renoprotective therapy in patients with proteinuric chronic kidney disease.~     Observational studies found that their effectiveness, however, is limited or even fully~     blunted in patients who eat large amount of salt.~      Experimental evidence indicates a renoprotective role of the vitamin D system in chronic~     renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin~     D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with~     type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor~     therapy. This effect, however, was largely restricted to subjects with daily sodium intake~     exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment~     with paricalcitol appears to be effective in particular in those patients who do not~     appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high~     salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by~     concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS~     inhibitors therapy, is worth investigating.~      The broad aim of this study is to evaluate the interaction between paricalcitol therapy and~     sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable~     background RAS inhibitor therapy.~   "
126958|NCT01393795|"~     The investigators hypothesise that pre-application of Qutenza® patches to the skin may~     reduce pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of~     Qutenza pre-application), in which case it would greatly improve the quality of life of the~     patients, and enable many more to continue with this treatment. It may also provide new~     information to support the use of Qutenza® patches for preventing and reducing pain produced~     by inflammation.~      The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8%~     patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary~     arterial hypertension patients, as assessed by changes in subjective pain rating score~     and/or pain and sensory testing.~   "
126959|NCT01393782|"~     The investigators propose a dose finding study to determine the feasibility of Angiotensin~     II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to~     increase mean arterial pressure, this could lead to future pharmacologic development based~     on the AII hormonal pathway. The investigators propose a 20 patient, randomized,~     placebo-controlled, blinded study in the treatment of high-output shock. Patients with~     high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4~     will be eligible. In addition, patients must already be receiving cardiac output monitoring~     and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous~     AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety~     and dose finding feasibility study. The investigators are starting with a small cohort~     consistent with similar types of studies. The investigators estimate that ten patients in~     each arm will generate a basis for determining if there is sufficient signal for AII to~     improve blood pressure at the doses outlined. The primary endpoint in the study will be the~     effect of AII on the standing dose of norepinephrine which is required to maintain a MAP of~     65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and~     creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged~     prior to day 30 will be contacted by telephone for this assessment.~   "
126960|NCT01393769|"~     For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the~     Reese-Ellsworth classification) in which enucleation would usually be the standard~     therapeutic approach, in this project the investigators propose an alternative conservative~     treatment using intra-arterial chemotherapy with melphalan, via direct administration by~     catheterization of the ophthalmic artery.~   "
126961|NCT01393756|"~     The purpose of the study is to assess the efficacy of the association of Lenalidomide~     (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone)~     in a population of patients with follicular lymphoma as measured by the response rate at the~     end of treatment.~   "
126963|NCT01393730|"~     The purpose of this research study is to determine if the addition of dutasteride to a~     regimen with abiraterone acetate and prednisone will improve on therapy in patients with~     castrate-resistant prostate cancer and metastatic disease. This study will also help~     determine the side effects of the study treatment and how often they occur.~   "
126964|NCT01393717|"~     This phase II trial studies how well brentuximab vedotin before autologous (taken from an~     individual's own cells) stem cell transplant works in treating patients with Hodgkin~     lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer~     growth in different ways by targeting certain cells.~   "
126965|NCT01393704|"~     The main purpose of this study is to compare blood loss at the time of laparoscopic or~     robotically-assisted laparoscopic myomectomy when using different amounts of dilute~     vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus.~     Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic~     surgery; although very little is know about the optimal dosage and administration.~      The investigators plan to perform a randomized clinical trial on patients scheduled for~     minimally invasive myomectomy. All patients will get the same overall amount of vasopressin.~     Patients will be assigned by chance to one of two groups: one group will receive higher~     volume of a more dilute vasopressin solution. The other group will receive a lower volume of~     a more concentrated solution. The investigators will collect information on operative blood~     loss and complications related to surgery.~   "
126966|NCT01393691|"~     Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major~     problems in clinical services. The aim of this study is to test the efficacy of two~     interventions designed for preschool children suffering from NTF: (a) a CBT adaptation~     combining parent involved play, which will include multiple standard cognitive-behavioral~     techniques, namely psycho-education, problem solving via play, gradual exposure and~     reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia~     Axline's (1947) eight basic principles of play therapy. Parents will take an active part~     both in and in between treatment sessions in both intervention groups. In addition to the~     review of the outcomes of these interventions, the proposed study aims to identify variables~     that moderate and mediate treatment effects.~      In an attempt to meet these aims, the investigators will recruit 90 children suffering~     severe NTF and their parents who seek treatment. At baseline the investigators will assess~     children's NTF and general fears, sleep patterns and disruptions, behavior problems and~     potential moderators (i.e. playfulness, oppositionality, desire for control and parental~     anxiety). Assessment will be based on both objective and subjective measures, including~     interviews with the child and parents, questionnaires and actigraphy. The investigators will~     then randomly assign these children to one of two conditions: CBT with parent involved play~     or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance,~     patient compliance, motivation etc.) will be evaluated after each of the active intervention~     sessions. The effects of the interventions will be assessed by comparing four time points:~     baseline, first week of intervention, 1 month and 6 months subsequent to administration.~      The main hypotheses of the proposed study are: (a) A positive correlation will be found~     between the severity of NTF and the severity of sleep disruption at baseline, and a~     reduction in NTF will be associated with an improvement in sleep; (b) Both interventions~     will significantly reduce nighttime fears, but greater impact will be evident in the CBT~     group; (c) Higher levels of playfulness and lower levels of oppositionality and desire for~     control, as well as parental anxiety will predict desirable outcomes. (d) Stronger~     therapeutic alliances, in addition to higher levels of motivation and compliance will be~     associated with greater intervention effectiveness.~   "
126967|NCT01393678|"~     The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and~     garlic oil. This components showed synergistic enhancing effects in previous tests. In phase~     2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on~     above, this study is phase 3 test to prove efficacy and safety of PENNEL.~   "
126968|NCT01393665|"~     The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic~     oil. The two components were confirmed to have complementary effects because of different~     operational mechanism in animal experiments, and were examined on humans in this study. Both~     BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity~     caused by toxic substances, and the purpose of this study is to confirm efficacy of and~     safety on human body of the agent and to determine its optimal dose.~   "
126969|NCT01393652|"~     This is a two part study. The purpose of the first part (Part A) is the evaluation of the~     pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The~     second part (Part B) of this study will focus on the exploratory pharmacodynamics of~     PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses~     selected in Part B will have been administered previously in the Part A of the study.~   "
126970|NCT01393639|"~     The purpose of this study is to compare the safety and efficacy of multiple doses of~     PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo~     in the treatment of rheumatoid arthritis. All subjects will also be receiving background~     treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for~     eight weeks followed by a 4 week period during which the dose of study medication will be~     gradually reduced. The efficacy of the study medications will be determined by assessing~     severity of the rheumatoid arthritis during the study and safety will be determined by~     adverse event reporting, laboratory tests and biomarker analysis.~   "
126971|NCT01393626|"~     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to~     severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is~     more effective than placebo (inactive drug).~   "
126972|NCT01393613|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses~     of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of~     schizophrenia.~   "
126973|NCT01393600|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses~     (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive~     dyskinesia in subjects with schizophrenia or schizoaffective disorder.~   "
126974|NCT01393587|"~     Recently, a new synthetic marker was developed, based on a molecule that is composed of~     Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor~     changes of oxidative stress.~      The investigators would like to assess the usefulness of this marker during positive~     pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection~     (ischemia induced by intra-abdominal pressure and vascualr compromise).~   "
126975|NCT01393574|"~     The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder~     (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an~     extent similar to that of stimulants treatment.~      In order to check this hypothesis children with a new ADHD diagnosis who also have sleep~     difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for~     one month. The main outcome will be improvement of the ADHD symptoms.~   "
126976|NCT01393561|"~     This is a multicenter clinical trial, phase III, superiority, controlled by active medicine,~     double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation~     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours~     and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel~     groups, and will receive the medicines of study, according of the randomization.~   "
126977|NCT01393548|"~     This is a multicenter clinical trial, phase III, non-inferiority, controlled by active~     medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation~     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours~     and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel~     groups, and will receive the medicines of study, according of the randomization.~   "
126978|NCT01393535|"~     The purpose of this study is to investigate the relationship between serum adiponectin and~     clinical prognosis in patients undergoing cardiac surgery.~   "
126979|NCT01393522|"~     The purpose of this study is to determine if milnacipran taken twice daily is effective in~     reduction of headache pain.~   "
126980|NCT01393509|"~     NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN).~     Dose escalation has been completed.~      The purpose of this study is to test a new drug, called PU-H71 for the first time in humans,~     to find out what effects, good or bad, this new drug has on the patient and the cancer at~     different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90~     is found in both normal and cancer cells, but may be more important in cancer cells.~     Attacking Hsp90 can stop the function of certain proteins that are needed for cancer cells~     to survive. The diseases that are part of this study may be especially sensitive to~     attacking Hsp90, and the investigators have seen signs of disease control in patients with~     MPN. This study is currently enrolling a cohort expansion for patients with~     myeloproliferative neoplasms (MPN).~   "
126981|NCT01393496|"~     To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on~     long-term neurodevelopmental outcome in extremely low birth weight infants.~   "
126982|NCT01393483|"~     The purpose of this study is to find out whether a protein, called mesothelin, found in the~     blood and tissue can be used as marker for esophageal cancer. Doctors at Memorial~     Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with~     abnormal cells or tissue of the esophageal to the levels of this protein in patients being~     treated for cancer for the esophagus.~   "
126983|NCT01393470|"~     Summary~      For ethical and practical reasons pre-licensure clinical efficacy phase III trials for GSK~     Biologicals' HPV-16/18 LI VLP AS04 vaccine used cervical intraepithelial grade 2 and above~     (CIN2+) lesions as surrogate efficacy endpoint for cervical cancer. The long-term impact of~     HPV vaccination on cervical cancer as well as other HPV-related non- cervical cancers is,~     however, an area warranting further exploration in the post-licensure setting. Results of~     the multinational phase III trial demonstrated high vaccine efficacy against CIN2+~     associated with HPV-16 and/or HPV-18, significant vaccine efficacy against CIN2+ and CIN3+~     irrespective of HPV type in the lesion as well as evidence of protection against CIN2+~     associated with HPV types 31 and 45 [Paavonen, et al. 2009]. Over time, vaccinated cohorts~     should benefit from a substantial reduction in the incidence of cervical cancer considering~     impact on oncogenic non-vaccine HPV types. This long-term study is conducted to evaluate the~     long-term impact of GSK Biologicals' HPV-16/18 vaccine on the occurrence of cervical~     pre-cancerous lesions and cervical cancer with the following objectives:~        -  To assess the long-term efficacy of the HPV-16/18 L1 VLP AS04 vaccine on the occurrence~          of cervical cancer including its immediate precursors (CIN3+): cervical intraepithelial~          neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) by comparing cohorts A and C~          (see below).~        -  To assess the efficacy of HPV-16/18 L1 VLP AS04 vaccine on the occurrence of the~          following potentially HPV related non-cervical cancers such as vulvar intraepithelial~          neoplasia, vaginal intraepithelial neoplasia, anogenital neoplasia and oropharyngeal~          neoplasia by comparing cohorts A and C (see below)~        -  To assess as an explanatory objective the occurrence of CIN3+ breakthrough cases~          associated with HPV-16 or HPV-18 infection in subjects vaccinated with HPV-16/18 L1 VLP~          AS04 vaccine by close surveillance of cohorts and cross vaccinated cohort B (see below)~      This prospective, observational cohort study is undertaken in originally 16-17 year-old~     Finnish females who have participated in the GSK Biologicals' HPV-008 trial (NCT00122681)~     with regular clinical follow-up, and can be divided in Cohort A: Female subjects from~     Finland who received HPV-16/18 L1 VLP AS04 vaccine in the HPV-008 study between May 2004 and~     May 2005 (N=2409), and Cohort B: Female subjects from Finland who received the Hepatitis A~     control vaccine in the HPV-008 study (N=2399). All subjects were offered the HPV-16/18 L1~     VLP AS04 vaccine or screening for cervical cancer at the end of the study (age 21-22): 50%~     of the subjects, chose not to take cross-over HPV vaccination at HPV-008 study end. Referent~     Cohort C: A population-based reference cohort of female subjects from Finland who have not~     been exposed to any HPV vaccine (either during a HPV vaccine trial, or commercially~     available vaccine; i.e. Cervarix or Gardasil), enrolled in this study in May - September~     2003 or May - September 2005, altogether 15536 subjects).~      Prospective data collection will start at the HPV screening invitation for each subject in~     2013. Several analyses are planned including an analysis at 8 years post-completion of the~     HPV-008 study (by 2020) and will provide a total evaluation time of approximately 15 years~     since first vaccination in the Cohort A.~      The study is self-contained for the primary and secondary endpoints. Data from the HPV-008~     trial will be used to address exploratory objectives mentioned above. Data collection will~     be performed using the databases from the University of Tampere.~   "
126984|NCT01393457|"~     The purpose of this study is to evaluate treatments designed to improve cocaine treatment~     success by combining medications that target cocaine-related cognitive impairments.~   "
126985|NCT01393444|"~     The purpose of this research study is to demonstrate that individuals with upper limb~     paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis~     and brain stem stroke can successfully achieve direct brain control of assistive devices~     using an electrocorticography (ECoG)-based brain computer interface system.~   "
126986|NCT01393431|"~     Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from~     lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the~     water condensed in the trap of expiratory arm of ventilator.In ICU the investigators~     measured pH in condensed water without interfering with patients treatment. A group of~     critically ill patients mechanically ventilated due to non pulmonary cause were followed~     until successful weaning, death or pneumonia. The investigators found that pH did not change~     along the study and it did not predict worsening condition.~   "
126987|NCT01393418|"~     The purpose of the study is to evaluate kidney biomarkers and determine if there is a~     correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac~     surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and~     managing patients at risk for kidney failure after cardiac surgery. To evaluate~     Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass~     period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).~   "
126988|NCT01393405|"~     There are fewer therapeutic options for patients with active ulcerative colitis (UC)~     compared to patients with active Crohn's disease (CD) and the investigators are facing a~     persistent unmet need for additional effective and affordable therapies for patients with~     UC. Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly~     (im) is an efficient therapy to induce and maintain steroid free remission in patients with~     CD. To evaluate the efficacy of a similar approach in patients with active ulcerative~     colitis the investigators conduct a double-blind, placebo controlled, randomized,~     multicenter, parallel group trial to investigate the safety and efficacy of 25 mg MTX~     applied subcutaneously once weekly in patients with active UC, who either failed 5-ASA~     therapy, or are steroid dependent or are intolerant or not responding to~     azathioprine/6-mercaptopurine therapy or have no response/ lost response to infliximab prior~     to the study inclusion. The study is designed as a drug withdrawal trial and includes two~     periods, the Induction Period (week 0-16) and the Maintenance Period (week 17-48). In the~     open label Induction Period every patient will receive a steroid taper, MTX 25 mg sq once~     weekly + daily folic acid 1 mg tablets for the induction of clinical response or remission.~     Patients responding to the open label MTX therapy and being off steroids between week 12-16~     will be randomized at week 16 1:1 to Placebo sq once weekly + daily folic acid 1 mg tablets~     + 2.4 g mesalamine or to MTX 25 mg sq once weekly + daily folic acid 1 mg tablets+ 2.4 g~     mesalamine. The Specific Aims of the trial are: i) To evaluate the safety and tolerability~     of 25 mg MTX applied sq once weekly over a time period of 48 weeks; ii) To evaluate the~     relapse-free survival of MTX maintenance therapy compared to placebo over a time period of~     32 weeks; iii) To evaluate the efficacy of MTX over a time period of 16 weeks to induce~     steroid free remission; iiii) To establish a DNA, plasma and serum library to enable the~     evaluation of clinical and pharmacogenomic models to predict the response to MTX therapy in~     patients with UC. With 25-30 participating centers actively enrolling, the investigators~     anticipate to complete enrollment for this study in a time period of 3 years. Completion of~     this trial will define the therapeutic value of MTX in UC, potentially changing the current~     therapeutic strategy in UC.~   "
126989|NCT01393392|"~     The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the~     immediate and long-term effects of a newly developed, tailored, intensive smoking cessation~     intervention among methadone maintained smokers and compared to a control condition~     (facilitated referral to the NJ Quitline). The newly developed intervention is evidence~     based, addresses the unique needs of methadone maintained smokers, is intensive, can be~     tailored to the individual, and builds on the strengths as well as addresses the gaps in~     previous treatments for methadone maintained smokers.~      The investigators hypothesize that: (1) three months and six months after beginning~     treatment, those in the tailored intervention condition will be more likely to be abstinent~     from smoking than those in the control intervention condition (primary outcome); (2) there~     will be a greater relapse rate in the control intervention condition between the three and~     six month follow-up points than in the tailored intervention condition; (3) three and six~     months after beginning treatment, those in the tailored intervention condition will have~     better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week,~     be more ready to quit, have greater self-efficacy for quitting, experience less nicotine~     dependence, and be more likely to have made a quit attempt) than those in the control~     intervention condition; (4) three and six months after beginning treatment, those in the~     tailored intervention condition will have better utilization of and adherence to smoking~     cessation pharmacotherapy, better mental and physical health, less perceived stress, greater~     social support, less drug and alcohol use, and greater involvement in drug and alcohol~     treatment than those in the control intervention condition; and (5) the newly created~     tailored intervention will be feasible and acceptable. .~   "
126990|NCT01393379|"~     The purpose of this study is to investigate the effect of endoscopic valve implantation in~     patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life~     in 10 patients in a prospective study. An improvement of objective parameters may also have~     a prognostic significance~   "
126991|NCT01393366|"~     The investigators plan to conduct a nurse-based telephone intervention study to minimize~     toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab~     (FCR) given frontline to Chronic Lymphocytic Leukemia patients.~   "
126992|NCT01393353|"~     The study evaluates a computerized cognitive therapy in patients with Parkinson's disease~     who have a mild cognitive impairment or mild dementia. The control group is trained using~     Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.~   "
126993|NCT01393340|"~     This pilot study is a double-blinded, randomized controlled, two-centre trial in which~     subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or~     placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE).~     During the treatment period and follow-up, the clinical efficacy of the treatment will be~     assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory~     Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and~     spirometry. Biological activity will be evaluated by measuring peripheral and local (in~     serum, in nasal secretions, biopsies) markers of inflammation.~      Study hypothesis~        1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal~          polyposis and comorbid asthma.~        2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal~          polyposis~        3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps~   "
126994|NCT01393327|"~     Purpose of this study is to investigate whether and to what extent a cautious respiratory~     and movement therapy can complement medical treatment and the condition, oxygen uptake,~     quality of life, the pulmonary vascular pressures, the size of the right heart and the~     6-minute walk distance in patients with pulmonary hypertension.~   "
126995|NCT01393314|"~     This is a randomized controlled trial of telemonitoring vs usual care provided by home care~     agencies for atients with HF.~      The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent~     care visits, unscheduled physician appointments, ER visits in patients with heart failure~     over the 60 day post hospitalization period.~   "
126996|NCT01393301|"~     This is the 1-year initial phase of a study to develop an integrated treatment for quitting~     smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up~     activities will include piloting the integrated treatment on a small group of individuals (N~     = 12), obtaining expert consultant and participant feedback, and development of the final~     treatment manual and procedures. The goal during this phase will be to establish feasibility~     of treatment delivery, participant acceptability, and potential for a treatment effect~     before conducting a pilot randomized trial of the treatment.~   "
126997|NCT01393288|"~     Every year, more than 5 million patients in the US experience postoperative nausea and/or~     vomiting (PONV) and in the ambulatory setting post-discharge nausea and/or vomiting (PDNV)~     is the most common cause for unanticipated hospital re-admissions. Similarly, millions of~     patients suffer from chemotherapy induced nausea and/or vomiting (CINV), and one out of five~     patients discontinues chemotherapy for this reason. Thus, the control of nausea and vomiting~     remains a major health concern for the investigators society. The investigatorsoverall goal~     is to further the understanding of nausea and vomiting and optimize antiemetic selection in~     order to facilitate individualized patient care.~      Unfortunately, current antiemetics reduce the incidence of nausea by only about one third.~     As a result, antiemetics are often combined, exposing patients to adverse events and drug~     interactions without evidence for the most effective combination. Moreover, it remains~     unclear why such a large amount of inter-individual variability exists in antiemetic~     responsiveness. 5HT3, NK1, and GABA receptors are targets for some of the most commonly~     prescribed anti-emetics. Furthermore, these receptors have many known genetic polymorphisms,~     including several linked to incidence of nausea and vomiting. Thus pharmacogenomic variation~     may in part explain interindividual differences in treatment responses and will be tested in~     this proposal.~      Leveraging the established infrastructure of the UCSF Clinical and Translational Science~     Institute, and the support of 6 patient recruitment sites, the investigators will enroll~     1280 high risk patients to three oral interventions with distinct mechanisms of action for~     nausea and vomiting. Investigating nausea and vomiting in ambulatory surgical patients is an~     excellent model for this trial owing to a high incidence, short observational period, and~     the ability to standardize and control potentially confounding variables. In this proposal,~     100% of patients will receive a single intraoperative dose of 4 mg ondansetron, which is~     similar to the 80% of patients who receive prophylaxis in common practice. Using a factorial~     design, these patients will be randomized to receive one out of eight possible combinations~     of the three interventions (ondansetron, aprepitant, lorazepam) versus placebo~     (ond+aprep+lora, ond+aprep, ond+lora, aprep+lora, ond, aprep, lora, or placebo). Thus, in~     this proposal 87.5% (7 out of 8 patients) will have antiemetic coverage for the~     postdischarge period, which is considerably higher than in common practice, where only 4% of~     patients have antiemetic coverage after discharge. The primary endpoint will be the~     prevention of nausea and vomiting within 48 hours after ambulatory surgery. The advantage of~     the factorial trial design is its high efficiency to systematically investigate multiple~     interventions while allowing us to test for potential interactions. It is also an ideal~     format for the simultaneous assessment of pharmacogenomic interactions of antiemetics in~     this proposal.~      To this end, the investigators will collect DNA samples and take advantage of the unique~     opportunity to investigate the effects of variation in candidate receptor genes in the~     context of the three treatment interventions for PDNV. This approach may in part explain~     inter-individual differences in drug efficacy and allow for future screening of at-risk~     patients. Specifically, the investigators will be assessing single nucleotide polymorphisms~     (SNPs) and copy number variants (CNVs) of targeted receptors for the antiemetics tested.~      Aim 1: To determine efficacy of three interventions for the prevention of PDNV.~      Hypothesis 1.1: Each intervention reduces the incidence of PDNV.~      Hypothesis 1.2: Efficacy of all interventions is independent so that efficacy of a~     combination can be derived from the efficacy of the individual interventions.~      Aim 2: To determine if drug response for anti-emetics is dependent upon genetic variance.~      Hypothesis 2: Efficacy of ondansetron, aprepitant and lorazepam to reduce PDNV differs with~     5HT3, NK1, and GABA receptor gene variation, respectively.~   "
126998|NCT01393275|"~     The purposes of the study are~        -  to determine if a supervised exercise intervention is improving the metabolic~          parameters in type 2 diabetes patients~        -  to investigate what kind of intervention (strength endurance training versus combined~          strength endurance training and rehabilitation exercise intervention)is more effective~          in improving the metabolic parameters in patients with type 2 diabetes~        -  to assess which exercise intervention induces higher effects to the metabolic rate and~          cardiac and pulmonary capacity~        -  to investigate what kind of intervention includes highest effects in long term~          persistence of these positive effects~   "
126999|NCT01393262|"~     The purpose of the research is to investigate multiple facets of non-traumatic and traumatic~     health issues. The majority of our research deals with mind-body aspects of health. The~     investigators often correlate different psychological measures against one another or match~     psychological and depression scores against standard of care objective measurements (grip~     strength and range of motion).~      The data repository also serves to streamline our studies and amalgamate many studies that~     are no more than minimal risk and do not involve randomization in any way.~   "
127000|NCT01393249|"~     The purpose of this study is to create a model enabling us to predict pancreatitis,~     hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with~     Acute Lymphoblastic Leukemia.~   "
127001|NCT01393236|"~     Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances,~     after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental~     analysis of heart rate variablity after arousals during sleep. We compared preoperative and~     postoperative results.~   "
127002|NCT01393223|"~     The purpose of this study is to assess the safety and tolerability of two doses of LP08~     compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly~     different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis~     design will be employed, i.e. the measured outcomes will be subjects' improvements in~     quantitative and qualitative measures of the disease condition being assessed prior to and~     after LP-08 instillations at four and eight weeks follow-up visits~   "
127015|NCT01393054|"~     Despite of the development of new anti hypertensive agents, hypertension in elderly is still~     a big health problem. Nigella sativa seed extract, derived from a small plant originating in~     Middle east which can be found abundantly in Asia, has shown small antihypertensive effect~     in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the~     effect but as it also shows anti-inflammatory and vasodilatory activity which are important~     contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus~     it has a superior potential benefit for this population. We will conduct a randomized,~     double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in~     elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract~     twice daily will have anti-hypertensive effect in the blood pressure of elderly with~     hypertension.~   "
127016|NCT01393041|"~     The purpose of this clinical study is to assess device deployment characteristics and~     performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6~     French device utilizing the SJM collagen.~   "
127179|NCT01390883|"~     The purpose of this study is to collect and assess information on safety and efficacy of~     fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology~     departments who are at high risk of venous thromboembolism.~   "
127003|NCT01393210|"~     Obesity is an important health problem of modern civilization. In Western societies, almost~     half of the adult population has problems with an increased body weight. Products containing~     nutritional fiber has been used by humans for thousands of years. However, beta-glucan as~     biologically active compound, present in these products, has been identified relatively~     lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and~     1,3D-1,4D.~      Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the~     study was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie~     diet on insulin sensitivity and the expression of selected proinflammatory cytokines in~     adipose tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal~     glucose tolerance.~      The study group consisted of 40 subjects with marked overweight or obesity (body mass index,~     BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or~     lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after~     receiving a full information about the aim and the design of the study, were recruited.~      At the beginning of the study, after subjects' qualification to the project and before the~     dietary intervention, the investigators performed:~        -  anthropometric measurements.~        -  oral glucose tolerance test.~        -  euglycemic hyperinsulinemic clamp.~        -  PBMC isolation before and after the clamp.~        -  biopsy of subcutaneous adipose tissue before the clamp.~        -  isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected~          genes with the Real Time PCR was measured.~        -  After the initial visit, participants received detailed instructions about low-calorie~          diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14~          days.~      Then, participants were randomly assigned to a group receiving or not beta-glucan~     preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects.~     Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN~     1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This~     preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is~     indicated by the manufacturer.~      After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations~     performed at the beginning of the study were repeated.~   "
127004|NCT01393197|"~     The purpose of this study is to evaluate the effects of Transcatheter Arterial~     Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is~     better,KMG microsphere or lipiodol?~   "
127005|NCT01393184|"~     Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence~     indicates combination with EGFR Target therapy can bring benefit for the patients. Senile~     Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable~     treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of~     the study Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of~     Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN was sponsored to~     evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN~     patients.~   "
127006|NCT01393171|"~     The purpose of this study is to evaluate the success rate of cystocele repair using~     polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a~     prospective randomized fashion. The study will be performed in a randomized, prospective,~     single-blinded fashion.~   "
127007|NCT01393158|"~     The purpose of this study is to obtain preliminary data regarding the safety and~     tolerability of apremilast in AD to support the design of larger controlled studies.~   "
127008|NCT01393145|"~     A study multicenter, phase III, randomized, open label study to evaluate the efficacy and~     safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in~     patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will~     enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic~     obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease~     or severe according to GOLD spirometric classification. The subjects will be allocated in 2~     parallel groups and will receive the medicines of study, according of the randomization~     during a 24-week.~   "
127009|NCT01393132|"~     Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced~     day-to-day function and significant discomfort. Tear substitutes are an important part of~     the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface~     often remains very irregular due to poor surface healing.~      The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal~     surface and has been studied in patients with recalcitrant corneal ulcers and erosions with~     significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May,~     2010).~      The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface~     healing, may be able to promote healing of the corneal surface allowing for more~     conventional modalities to take over and maintain a smooth and regular ocular surface. The~     investigators hope to be able to demonstrate an improvement in visual acuity, surface~     healing and a reduction in dry-eye related symptoms.~   "
127010|NCT01393119|"~     The purpose of this study is to determine the appropriate loading and maintenance dose of~     GTx-758 to reach and maintain castration for the duration of the study.~   "
127011|NCT01393106|"~     This study will evaluate the efficacy and safety of idelalisib in participants with relapsed~     of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall~     response rate.~      Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150~     mg twice daily. Treatment with idelalisib will continue until tumor progression or~     unacceptable toxicity.~   "
127012|NCT01393093|"~     The purpose of the study is to evaluate the effects of Transcatheter Arterial~     Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular~     Carinoma(HCC).~   "
127013|NCT01393080|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope~     located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).~     Clinical efficacy has been shown in adults with head and neck cancer. This study assesses~     the efficacy and safety of the combination of Nimotuzumab administered concomitantly with~     chemotherapy in patients with NSCLC. This is a randomized, muti-center sites trial of this~     treatment.~   "
127014|NCT01393067|"~     Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic~     liver transplantation. This study compares endoscopic treatment with implantation of~     multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent~     (cSEMS).~   "
127017|NCT01393028|"~     Direct non-invasive coronary imaging by computed tomography (CT) has the potential to~     improve the workup of patients with stable chest pain complaints. The objective of the study~     is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic~     driven workup of suspected coronary artery disease in comparison to the standard workup~     using stress testing.~   "
127046|NCT01392651|"~     Women with urinary stress incontinence who underwent surgical treatment by either TVTO or~     TVTS will be enrolled. The investigators will collect data from charts and use a telephone~     questionnaire to check the outcome of these women. Physical examination findings will also~     be incorporated.~   "
127018|NCT01393015|"~     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver~     automatically oxygen and to enable a remote medical monitoring with a homogeneous patient~     population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.~      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses~     and medical personnel and there are advantages to use this system. In comparison with the~     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a~     better control of the oxygen saturation in function of designed target, reducing the~     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical~     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse~     personnel and to improve the support with centralized monitoring in the FreeO2 group.~   "
127019|NCT01393002|"~     This is a structured web-based survey in selected hospitals with intensive care units in~     Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the~     field of invasive mycoses.~   "
127020|NCT01392989|"~     Allogeneic stem cell transplantation (transplant of blood cells from another individual) is~     a treatment option for patients with Myelodysplasia or Myeloproliferative Disorders. During~     the course of this study, we will attempt to learn whether a particular type of blood cell,~     called a Cytokine Induced Killer (CIK) cell may add benefit to allogeneic stem cell~     transplantation. CIK cells are present in small quantities in the bloodstream but their~     numbers can be expanded after a brief period of nurturing in a laboratory.~   "
127021|NCT01392976|"~     The purpose of this study is to compare the pharmacokinetic and safety profiles of two~     formulations of CO-1.01 in patients with Advanced Solid Tumors.~   "
127022|NCT01392963|"~     A 24-week Randomized, Double-blind study treating people who suffer from depression who also~     have moderate to severe frown lines in forehead region with Botox injections. Subjects~     participating will have their photos taken and complete a questionnaire regarding their~     depression. They will see a psychiatrist at every visit who will assess their depression.~   "
127023|NCT01392950|"~     A clinical study report follows; this clinical study evaluated the safety and efficacy of~     SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air~     Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.).~      Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens~     maintenance, care and storage.~   "
127024|NCT01392937|"~     A clinical trial was conducted to assess the safety and acceptability of the Sauflon~     Multipurpose Solution when used with four different silicone hydrogel contact lens brands~     and one conventional hydrogel control lens was conducted over a period of two months, with a~     control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at~     six investigator sites and a total of 257 subjects were enrolled. The results of this study~     showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose~     Solution to the predicate device for its intended use.~   "
127025|NCT01392924|"~     Primary Objective:~      - To confirm safety and tolerability of global recommended phase three dose (RPTD) of~     SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with~     solid tumors.~      Secondary Objectives:~        -  To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408~          in CDD treatment schedule in patients with solid tumors.~        -  To gather preliminary efficacy data after repeated administration of SAR245408 in~          patients with solid tumors.~   "
127026|NCT01392911|"~     This is the first trial in a series of clinical trials that aim to bring the concept of high~     dose rifampicin beyond phase II of clinical development.~      The safety, tolerability, extended early bactericidal activity (EBA) and pharmacokinetics of~     several doses of Rifampicin with or without standard doses of Isoniazid, Pyrazinamide and~     Ethambutol in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB will~     be assessed. The objective of this study is to find the maximum tolerable dose of Rifampicin~     as monotherapy and in combination with the currently available Isoniazid, Pyrazinamide and~     Ethambutol.~      The subjects will be in the study for 24-31 days. After a screening period of 9-3 days, the~     subjects will receive treatment with Rifampicin as single drug during 7 days (monotherapy).~     This treatment will be followed by treatment with 7 days of Rifampicin and Isoniazid,~     Pyrazinamide and Ethambutol (combination therapy), and 7-8 days treatment with standard TB~     medication.~      All subjects will be closely monitored for side effects. This monitoring will include daily~     interviews and physical examination, and ECG evaluation and blood and urine analyses at~     specific intervals.~      During the 7 days of monotherapy, after the second day of the combination therapy and at the~     end of the combination therapy, overnight sputum will be collected from the patients to~     investigate the potency of high dose rifampicin to reduce this number of bacilli.~      The Rifampicin dose will be increased step by step and group by group. The control group~     will receive the standard dose of 10 mg Rifampicin/kg, whereas the first treatment group~     will receive 20 mg/kg. The Rifampicin dose will only be further increased for a next group~     of patients, if this is expected to be safe.~      Rifampicin is widely available and not expensive. Physicians all over the world have~     experience with this drug and its adverse effects. Should this study be successful, the~     highest dose of Rifampicin that this safe and tolerable will be given to a larger group of~     patients. in the next study.~      If increasing the dose of Rifampicin proves to be safe and effective, a higher dose of~     Rifampicin could be implemented broadly and quickly, and it would benefit many patients~     worldwide.~   "
127027|NCT01392898|"~     Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2~     diabetes. Although insulin is an effective treatment modality, this is often at the expense~     of significant weight gain. Weight gain is obviously undesirable in an already overweight~     population, but may also deter further optimization of insulin therapy. Large~     inter-individual differences exist in the level of weight gain after initiation of insulin~     therapy, but no clear predictive factors have prospectively been identified thus far.~      Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic~     control and reduces weight. We hypothesize that in patients who show (excessive) weight gain~     after introducing insulin therapy, adding liraglutide is effective in reversing body weight~     while preserving glycaemic control.~   "
127028|NCT01392885|"~     To determine the effects of aerobic exercise on hippocampal volumes and severity of~     psychotic symptoms in a population of psychosis patients compared to healthy age/gender~     matched volunteers. Psychosis patients often suffer from a number of cognitive difficulties,~     including poor memory function, poor problem-solving capacity and difficulties with~     attention and concentration. These problems are not well addressed by current clinical~     treatments. Evidence from aging research strongly suggests that increased cardiovascular~     fitness may provide numerous cognitive benefits by promoting brain growth, particularly in~     the frontal lobes and the hippocampi. The current study will measure the effects of aerobic~     exercise on brain volumes in a population of chronic psychosis patients to determine if 1)~     hippocampal volumes increase in response to exercise and 2) if parallel improvements in~     cognitive functioning occur.~   "
127045|NCT01392664|"~     Women who had urinary stress incontinence and underwent one of two procedures: the classic~     TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.~   "
127029|NCT01392872|"~     Multiple Sclerosis is the first cause of neurological handicap in France. The importance of~     cognitive disabilities, their evaluation and their impact on patients' life have only been~     comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis~     (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments~     on cognitive disabilities, tiredness state, emotion and quality of life in general, on a~     lengthened period.~   "
127030|NCT01392859|"~     Asthma, a chronic disease which produces significant morbidity and mortality in children, is~     a significant health problem to a large segment of society. Despite considerable advances in~     the diagnosis and treatment of asthma over the past several years, a sizeable portion of~     patients do not respond to the core treatments. The investigators are now learning that~     the underlying pathophysiology of disease is different among patients with asthma therefore;~     treatments which are beneficial in some patient groups may be not achieve affect in other~     groups.~      Antihistamines have been studied in the past for the treatment of asthma. These studies have~     shown that there may be a beneficial effect of antihistamines in patients with allergic~     asthma where histamine likely plays a large role in disease and treatment response. However,~     there is not enough evidence to include these drugs in the standard treatment of asthma.~      The investigators hypothesize that histamine plays a definable, significant role in disease~     pathogenesis and treatment response in children with allergic asthma. The investigators plan~     to test this overall hypothesis through two specific aims. The first aim will characterize~     the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be~     accomplished by comparison of the microvasculature response to histamine in children with~     allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis~     with laser Doppler (HILD) monitoring, to determine potential phenotype-associated~     differences in the pharmacodynamic response to histamine. The investigators will also~     investigate the role of genetic variation in the observed differences in HILD between the~     two groups. The second aim will characterize the pharmacodynamic response to antihistamines~     via HILD in children with an exaggerated histamine response compared to children with a low~     histamine response. This aim will be accomplished through conduct of a randomized,~     double-blind, placebo-controlled cross-over trial of levocetirizine (LCT) in the two groups~     (high histamine and low histamine) and observing the difference in antihistamine~     pharmacodynamics in the two groups. The investigators will also investigate the effect of~     pharmacokinetic variation and genetic variation in the histamine pathway on the observed~     pharmacodynamic drug response.~   "
127031|NCT01392846|"~     This is a prospective, observational, cohort study to evaluate the relative efficacy and~     safety of Resolute Integrity stent compared to other (drug eluting stents) DES.~   "
127032|NCT01392833|"~     Some years ago the investigators designed a randomised trial to prospectively evaluate~     whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids~     (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral~     prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in~     adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine <=2.0~     mg/dl.~      In order to test the efficacy of the combination of steroids with azathioprine at various~     degree of renal function deterioration by extending the trial to patients with more advanced~     disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal~     biopsy. Treatment will last one year: methylprednisolone 1 g i.v. for three consecutive days~     at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day~     for six months, then 0.2 mg/kg every other day for further 6 months. The primary outcome was~     renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes~     were proteinuria over time and the number and types of adverse events in the two groups~     assessed every month for the first six months, every two months from the 6th to the 12th~     month and every three months thereafter. The planned duration of follow up is five years.~   "
127033|NCT01392820|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214~     in elderly healthy Japanese volunteers.~   "
127034|NCT01392807|"~     The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with~     impaired hepatic function versus subjects with normal hepatic function.~   "
127035|NCT01392794|"~     A study to compare time-course changes of plasma concentration of YM060 after intake of~     conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be~     administered without water.~   "
127036|NCT01392781|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of~     anovulatory infertility among reproductive aged women. According to the revised criteria of~     2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging~     evidence supporting the existence of different levels of cardiometabolic risk between the~     four phenotypic groups of the syndrome. The purpose of this study is to determine the~     cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the~     four phenotypes of the syndrome as well as the levels of low inflammation serum markers and~     the possible correlations of the between the outcomes.~   "
127037|NCT01392768|"~     The purpose of this study is to determine whether levetiracetam as adjunctive therapy is~     effective in the treatment of partial seizures, with or without secondary generalization,~     associated with refractory focal epilepsy.~   "
127038|NCT01392755|"~     This randomized, open-label study will evaluate the effect of food, and the effect of~     omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be~     assigned to one of two treatment groups. Volunteers in both groups will receive oral doses~     of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of~     omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.~   "
127039|NCT01392742|"~     This observational study will evaluate predictors of early on-treatment response and~     sustained virological response in patients with chronic hepatitis C receiving Pegasys~     (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24~     or 48 weeks) and 24 weeks after the end of treatment.~   "
127040|NCT01392729|"~     This prospective observational study will evaluate the efficacy and safety of Avastin~     (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated~     metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.~   "
127041|NCT01392716|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in~     treatment-naive patients with non-bulky follicular non-Hodgkin`s lymphoma. The anticipated~     time on study treatment is 3 months.~   "
127042|NCT01392703|"~     The purpose of the study is to compare the blood levels of dasatinib in healthy participants~     who received tablet formulation with those of healthy participants who received liquid and~     tablet-dispersed formulations of the drug.~   "
127043|NCT01392690|"~     The purpose of this study is to assess the impact of a primary prevention program for~     anxiety disorders.~      This study was completed between 2000 and 2002, with the final report transmitted to the~     Quebec ministry of health in 2003.~   "
127044|NCT01392677|"~     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in~     patients with type 2 diabetes who have inadequate glycaemic control on a background~     combination of metformin and sulfonylurea.~   "
127047|NCT01392638|"~     Sildenafil citrate slightly reduces blood pressure in treated hypertensives patients.~     However, it is unknown if the simultaneous use of sildenafil plus, at least, 3 classes of~     antihypertensive agents in patients with resistant arterial hypertension may have a synergic~     effect on the patients blood pressure. Moreover, sildenafil improves the endogen nitric~     oxide effects. The nitric oxide is an important signaling molecule in the body that~     contributes to vessel homeostasis by inhibiting vascular smooth muscle contraction and~     growth. Hypertension often impaired NO pathways. Nitric oxide is produced by an enzyme,~     called nitric oxide synthase (NOS3), that show some genetics variants, which means that this~     enzyme can be different from person to person. Therefore, the objective of the present study~     is to examine the influence of a genetic variant (known to affect NOS3 levels) in sildenafil~     acute effects on hemodynamic and cardiovascular function. The investigators hypothesis is~     that individuals with the genetic variant associated to higher levels of NOS3 will have more~     benefits from sildenafil treatment.~   "
127048|NCT01392625|"~     The technique of transplanting progenitor cells into a region of damaged myocardium, termed~     cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or~     repair necrotic, scarred, or dysfunctional myocardium2-4. Ideally, graft cells should be~     readily available, easy to culture to ensure adequate quantities for transplantation, and~     able to survive in host myocardium; often a hostile environment of limited blood supply and~     immunorejection. Whether effective cellular regenerative strategies require that~     administered cells differentiate into adult cardiomyocytes and couple electromechanically~     with the surrounding myocardium is increasingly controversial and recent evidence suggests~     that this may not be required for effective cardiac repair. Most importantly,~     transplantation of graft cells should improve cardiac function and prevent adverse~     ventricular remodeling. To date, a number of candidate cells have been transplanted in~     experimental models, including fetal and neonatal cardiomyocytes5, embryonic stem~     cell-derived myocytes6, 7, tissue engineered contractile grafts8, skeletal myoblasts9,~     several cell types derived from adult bone marrow10-15, and cardiac precursors residing~     within the heart itself16. There has been substantial clinical development in the use of~     whole bone marrow and skeletal myoblast preparations in studies enrolling both~     post-infarction patients, and patients with chronic ischemic left ventricular dysfunction~     and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have~     also been studied clinically.~      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for~     cardiac repair. The totality of evidence from trials investigating autologous whole bone~     marrow infusions into patients following myocardial infarction supports the safety of this~     approach. In terms of efficacy, increases in ejection fraction are reported in the majority~     of the trials.~      Non-ischemic dilated cardiomyopathy is a common and problematic condition; definitive~     therapy in the form of heart transplantation is available to only a tiny minority of~     eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less~     than for acute MI, but represents a potentially important alternative for this disease.~   "
127049|NCT01392612|"~     We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane~     B2 (TXB2) and endothelial cell function.~      Six male and six female subjects received recombinant human epoetin alpha (Erypo®)~     intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48~     and 72 hours after administration.~   "
127050|NCT01392599|"~     The purpose of this study is to investigated and evaluated the effectiveness of a new~     surgical technique for the treatment of severe chronic pain stages (Complex Regional Pain~     Syndrome Type II).~   "
127051|NCT01392586|"~     SUBMIT is a clinical trial that intends to answer the question whether up front breast~     surgery in patients with primary distant metastatic breast cancer will result in an~     improvement of the 2-year survival compared to the survival achieved with systemic therapy~     and delayed local treatment or systemic therapy alone.~      Randomization will take place immediately after the diagnosis of primary distant metastatic~     breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS)~     followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed~     local treatment of the breast tumor.~      The primary endpoint of this trial is the 2-years survival. Quality of life is one of the~     most important secondary endpoints.~   "
127052|NCT01392573|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira)~     and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their~     pre-trial treatment with metformin throughout the entire trial.~   "
127053|NCT01392560|"~     This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular~     filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects~     with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the~     safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.~   "
127054|NCT01392547|"~     This trial is conducted globally. The purpose of this trial is to confirm the efficacy and~     safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.~   "
127055|NCT01392534|"~     One of the most common adverse effects resulting from the therapy with thiazides,~     thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation~     of plasma potassium may be a life-threatening condition due to increased risk of arrythmias.~     Moreover, it has been postulated that decrease in plasma potassium level may negatively~     affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The~     main goal of this study is to assess the efficacy and safety of~     telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including~     the effects of the therapy on plasma potassium level and also on selected parameters of~     glucose and lipid metabolism.~   "
127056|NCT01392521|"~     The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated~     protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent~     treatments in other phase I studies. This study will test the combination of these two drugs~     to try and answer the following questions:~        1. What are the side effects of the combination of Copanlisib and Refametinib~          (BAY86-9766)when given together at different/increasing dose levels?~        2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future~          clinical research studies?~        3. How much Copanlisib is in the blood at specific times after administration and does~          adding Refametinib (BAY86-9766) have an affect?~        4. How much Refametinib (BAY86-9766) is in the blood at specific times after~          administration and does adding Copanlisib have an affect?~        5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on~          tumors?~   "
127057|NCT01392508|"~     The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used~     as a marker of severe sepsis (including septic shock) in patients presenting to the~     emergency department with suspected infection.~   "
127058|NCT01392495|"~     This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety,~     tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension~     patients.~   "
127059|NCT01392482|"~     Multicentre, retrospective observational cohort study based on LHU administrative databases~     aimed to described the pharmacoutilization of antipsychotics in patients affected by~     schizophrenia and bipolar disorder, the resource consumption and medication adherence. A sub~     analysis will be performed for those patients switching from Quetiapine IR to Quetiapine XR~     and comparing the periods before and after the switch.~   "
127060|NCT01392469|"~     This study will investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan~     and sildenafil at steady state when co-administered to pulmonary arterial hypertension~     patients.~   "
127061|NCT01392456|"~     The aim of the study is:~        1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in~          Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by~          Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient~          instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.~        2. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with~          implant-supported overdentures with three different types of retention: Retentive~          Anchors, Magnets, Locator.~   "
127062|NCT01392443|"~     The objective of this study is to determine the efficacy of INC424 as assessed by reduction~     in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV)~     MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the~     effects of INC424 on patient reported outcomes and the duration of response as assessed by~     reduction in spleen volume will also be assessed.~   "
127063|NCT01392430|"~     The purpose of this study is to compare the incidence of opportunistic infections between~     HIV-infected patients who continue and discontinue primary or secondary prophylaxis for~     opportunistic infections in whom receiving combination antiretroviral therapy and achieve~     undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.~   "
127064|NCT01392417|"~     Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or~     Posterior prolift at least a year after the surgery.~      The data from the charts and from telephone conversations with the patients will be entered~     to a database. Physical examination data will also be incorporated.~   "
127065|NCT01392391|"~     Chronic hemiparetic stroke is associated changes in body composition, skeletal muscle and~     cardiometabolic health; specific changes include paretic limb muscular atrophy, increased~     intramuscular fat deposition, elevated prevalence of impaired glucose tolerance and type 2~     diabetes. This randomized intervention study compares a 6 month task oriented exercise~     programs versus control with both groups receiving best medical stroke care according to~     American Stroke Association Get with the Guidelines. The hypothesis is that is 6 months of~     task-oriented exercise initiated early across the sub-acute period of stroke can prevent or~     ameliorate the natural course of these body composition, skeletal muscle and cardiometabolic~     health changes.~   "
127066|NCT01392378|"~     The purposes of this study are assess the immunological response (measure the amount of~     antibodies, i.e. proteins that fight off germs) produced by children after they have been~     given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months~     of age when medications to prevent fever are given on the same day as the vaccination. Also~     to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who~     receive medications to prevent fever on the day of vaccination.~   "
127067|NCT01392365|"~     The aim of this study is to develop a scoring system and a prediction model for differential~     diagnosis between intestinal tuberculosis and Crohn's disease.~   "
127068|NCT01392352|"~     Pazopanib is a new cancer drug that works by limiting the growth of new blood vessels in~     tumours. About half of patients who take pazopanib develop high blood pressure~     (hypertension). This side effect can make patients have to reduce or stop their cancer~     treatment, and can cause other health problems. The aim of this study is to find out exactly~     how the drug causes high blood pressure.~   "
127069|NCT01392339|"~     Obstructive sleep apnea is a multi-component disease. This study will test the hypotheses~     that hypoxia per se modulates gene expression in animal model of sleep apnea and these~     results may be translated with alterations that occur in apneic patients. Thus, we aim to~     integrate basic and clinical research to shed light on novel candidate genes involved in~     sleep apnea.~   "
127070|NCT01392326|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor therapy.~   "
127071|NCT01391559|"~     Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are~     uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One~     possible explanation is that the patient is unable to inhale the dry powder bronchodilator~     medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR).~     A PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus~     device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1)~     measured at two hours after inhalation of the study medication will be higher with~     arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg)~     inhaled from the Diskus.~   "
127072|NCT01391546|"~     PRIMARY OBJECTIVES~      Two co-primary objectives are:~        -  To demonstrate that ZOSTAVAX administered by intramuscular route (IM) is non-inferior~          to ZOSTAVAX administered by subcutaneous route (SC)~        -  To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise~          of varicella zoster virus (VZV) antibody titres from pre to 4-week post-vaccination~      SECONDARY OBJECTIVES~      Immunogenicity objectives~        -  To evaluate the immunogenicity as measured by VZV antibody titres at 4 weeks following~          ZOSTAVAX administered by IM or SC route~        -  To evaluate the immune response as measured by a second assay, the VZV Interferon gamma~          Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or~          SC route~      Safety objective~      - To describe the safety profile of ZOSTAVAX administered by IM or SC route~   "
127083|NCT01392222|"~     The purpose of this study is to understand more about why some patients choose to have~     surgery to treat their papillary microcarcinoma (PMC) and others choose to have their~     papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may~     need surgery (referred to as active surveillance). The investigators also hope learn more~     about what patients and their family members worry about or feel they will gain from surgery~     or active surveillance.~   "
127073|NCT01391533|"~     Primary Objectives:~      To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of~     SAR125844 when administered as single agent at the MTD.~      To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene~     amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer~     [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene~     amplification.~      Secondary Objectives:~      To characterize the global safety profile including cumulative toxicities. To evaluate the~     pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).~      To assess preliminary antitumor activity in patients with measurable/evaluable disease,~     according to RECIST 1.1 criteria.~      To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification~     status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study,~     in the escalation part only.~      To evaluate other pharmacodynamic biomarkers and help selection of patients who could~     benefit from SAR125844.~      To explore MET-gene amplification status in circulating DNA.~   "
127074|NCT01391520|"~     This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron~     chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney~     Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who~     are undergoing diagnostic or interventional coronary angiography will be randomized to~     either placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of~     randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the~     trial will be the difference in a composite of specified renal and cardiovascular clinical~     events occurring through Day 90.~   "
127075|NCT01391507|"~     The purpose of this study is to investigate the effect of COR-1 in combination with standard~     therapy in patients with heart failure. The safety and tolerability of COR-1 will also be~     assessed.~   "
127076|NCT01391494|"~     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth~     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family~     Picornaviridae.~      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in~     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these~     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by~     EV71 infection. Because of these EV71 infection-related public health issues, the research~     and development of EV71 vaccine candidates have been heavily promoted.~      Recently, several EV71 vaccine candidates have been evaluated in animals but no final~     results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit~     vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs).~      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a~     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by~     SFDA in China, Dec. 2010. The phase I clinical trial has been carried out, during four~     months, in Guangxi Province, China. The purpose of this study is to evaluate the safety,~     tolerability and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults~     (from 18 to 49 years old), children (from 3 to 11 years old) and infants (from 6 to 35~     months old).~   "
127077|NCT01392313|"~     The investigators will measure renal function in subjects ingesting carnitine to determine~     if the product alters renal function.~   "
127078|NCT01392300|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the upper limb are effective in treating spasticity in patients after stroke.~   "
127079|NCT01392287|"~     This study involves collaboration between McLean Hospital, Geriatric Medicine at the~     Cambridge Health Alliance (CHA) and other sites within the Partners and Harvard Medical~     School network. The investigators plan to recruit individuals 55 to 89 years old with~     treatment resistant depression. Someone with treatment resistant depression for this study~     may be someone who still has sad or low feelings and thoughts even though he/she is taking~     an antidepressant medication for at least 8 weeks to help relieve his/her depression. During~     the study, subjects will gradually add memantine hydrochloride in dosages up to 20 mg/day~     for 8 weeks to their standard antidepressant treatment.~      The investigators are doing this research study to help answer 3 questions:~        1. Do older adults with treatment resistant Major Depression have lower levels of a~          chemical in the brain called NAAG than older adults without Major Depression?~        2. Do older adults with naturally low NAAG levels do better on memantine hydrochloride~          treatment than older adults with higher amounts of this chemical on memantine~          hydrochloride treatment?~        3. Do older adults with treatment resistant depression have more problems with memory and~          concentration than older adults without depression?~      The investigators are also interested in looking at electrical and neuronal activity of the~     brain, spiritual beliefs, and fatigue in relationship to depression.~      The investigators hypothesize that:~        1. Older individuals with treatment resistant Major Depression will have lower levels of~          NAAG compared with age-matched older control subjects.~        2. Older adults with treatment resistant depression and low NAAG levels will do better on~          treatment with memantine hydrochloride than older adults on memantine with higher NAAG~          levels.~        3. Older adults with depression will do better on tests of attention and executive~          functioning after treatment with memantine hydrochloride.~        4. Healthy controls will do better on tests of attention and executive functioning than~          older adults with depression.~   "
127080|NCT01392274|"~     This study will collect data from patients undergoing an ERCP procedure with probe-based~     Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to~     evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary~     stricture when associated with other diagnostic information (standard ERCP and tissue~     sampling).~   "
127081|NCT01392248|"~     1. Rationale The inter-individual pain experience immediately after surgery is~          considerable. In addition, a number of patients develop chronic post surgery pain~          (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both~          acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic~          back pain, it was demonstrated how subjectively reported pain is associated with~          specific electroencephalography (EEG) parameters, namely the N2 and P3 components of~          the pain event-related potential (ERP). It was concluded that ERP was associated with~          self-reported pain in daily life up to two weeks after the measurement. This resulted~          in the current hypothesis that EEG may be a predictor for postoperative pain.~        2. Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will~          undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be~          repeated 6 months postoperatively.~           Study population: Female patients with breast cancer who will undergo breast surgery,~          between the ages of 18 to 65 years.~        3. Main study parameters/endpoints Primary outcome is postoperative pain, measured in a~          pain diary 4 days postoperatively. Secondary outcomes are development of chronic post~          surgery pain and quality of life. The main goal is to develop a comprehensive~          prediction model for acute and chronic postoperative pain after breast cancer surgery,~          based on the EEG results of the five vulnerability experiments.~   "
127082|NCT01392235|"~     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,~     Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.~      PURPOSE: This phase II trial is studying how well famitinib works in treating patients with~     recurrent and/or metastatic NPC.~   "
127084|NCT01392209|"~     The best dose of radiation to be given with bevacizumab is currently unknown. This study~     will use higher doses of radiation with bevacizumab than have been used before. This study~     will test the safety of radiation given at different doses with bevacizumab to find out what~     effects, good and/or bad, it has on the patient and the malignant glioma or related brain~     cancers.~   "
127085|NCT01392196|"~     This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary~     aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is~     safe and determine the evidence of a response to renal denervation in patients with Heart~     Failure.~   "
127086|NCT01392183|"~     The goal of this clinical research study is to compare pazopanib to temsirolimus in the~     treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be~     studied.~      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for~     tumor growth. This may prevent or slow the growth of cancer cells.~      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells~     to die.~   "
127087|NCT01392170|"~     The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a~     (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of~     this treatment combination will also be studied.~      Pegasys is a form of the drug interferon. It is designed to help the body's immune system to~     fight infections. It may also affect the body's response to cancer.~      A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a~     protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from~     growing, and may cause them to die.~      You are already receiving a TKI. This consent form will describe the administration of~     Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys,~     and any risks/benefits there may be from receiving Pegasys.~   "
127088|NCT01392157|"~     The main side-effect of Implanon is the changes induces in bleeding patterns including~     amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without~     any previous symptom and it was characterized as breakthrough bleeding (BTB). BTB is the~     main causes of early discontinuations. Unfortunately, there is no indication to predict~     prior to insertion what sort of bleeding pattern any individual woman may have after~     insertion and the proposed treatments were disappointed. Nevertheless, previous studies with~     other progestin-only contraceptives (including Implanon) provide evidence that the provision~     of adequate and intensive counseling to potential users and new acceptors about bleeding~     changes can help to improve method continuation.~      The availability of Implanon in the public sector could help in the development of~     strategies to introduce the method in the public sector network and the training of medical~     residents.~   "
127089|NCT01392144|"~     The goal of this clinical research study is to learn if the level of nitric oxide you~     breathe out may relate to the amount of breathing complications that you may experience due~     to radiation treatment.~   "
127090|NCT01392131|"~     Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma~   "
127091|NCT01392118|"~     The purpose of this study is to investigate the risk factor, molecular character and~     susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia~   "
127092|NCT01392105|"~     Early reperfusion strategies in tandem with remarkable advances in drugs and devices for~     treating myocardial infarction (MI) have contributed to a reduction in early mortality, but~     cardiovascular disease remains the leading cause of death worldwide. Current management~     strategies cannot solve the problem of cardiomyocyte loss and consequent progression of~     heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing~     the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive~     therapeutic candidates because of their high capacity for replication: paracrine effect:~     ability to preserve potency: and because they do not cause adverse reactions to allogeneic~     versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but~     only one clinical trial using MSCs via the intracoronary route in the setting of acute~     myocardial infarction (AMI) has been carried out. The investigators therefore assessed the~     safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in~     patients with AMI.~   "
127093|NCT01392092|"~     N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has~     approved for several medical uses, such as dissolving mucus in patients with breathing~     problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from~     toxic substances.~      Some recent studies suggest that NAC could be useful in the treatment of other disorders~     including addictions. One purpose of this study is to determine whether NAC alters the level~     of brain glutamate (a chemical that excites brain cells). The other main purpose is to~     determine whether NAC affects how much cocaine people use.~   "
127094|NCT01392079|"~     Aims and objectives~        -  Assessment of the efficacy of the study treatment in the study population in terms of~          response rate, progression-free survival, failure-free survival and overall survival.~        -  Acquisition of further data to expand the data base on the toxicity of the study~          treatment.~        -  Assessment of the efficacy of the study treatment in biological risk groups.~        -  Assessment of response in terms of minimal residual disease. Number of patients and~          estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line~          therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65~          fludarabine-refractory irrespective of 17p status).~      Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two~     years maintenance treatment.~   "
127095|NCT01392066|"~     The purpose of this study is to describe psychosocial adjustment in patients with breast~     cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study~     mutual influences of the partner on the patient and vice versa, and to identify risk and~     protective factors that influence the adjustment process in both patients and partners. The~     overall aim is to generate knowledge that helps enables us to integrate the partners' needs,~     problems and resources in treatment and rehabilitation of breast cancer patients.~   "
127131|NCT01391598|"~     The study's primary objective is to evaluate the effect of intravenous lidocaine on pain and~     plasma interleukin-1 (IL-1), interleukin-6 (IL-6) and substance P in patients with~     fibromyalgia.~      As secondary objectives: evaluate the clinical manifestations, and plasma concentration of~     lidocaine.~   "
127096|NCT01392053|"~     The objective of this research is to evaluate the effect of massage therapy as a resource~     for pain relief during the active phase of labor. The research will be of type randomized~     controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral~     Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups~     (lumbosacral massage) and control (routine maternity) and will be assessed before and after~     therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation~     will be performed by numerical category scale, Diagram Location of Pain and Pain~     Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction~     questionnaire.~   "
127097|NCT01392040|"~     The purpose of this study is to determine whether the new algorithm is safety and effective~     in proposing the dosage and the timing of oral anticoagulant therapy.~   "
127098|NCT01392027|"~     This proposed project is designed to collect data and specimens from patients/subjects~     presenting to the University of Michigan with a disease affecting the pancreas (or specific~     control populations). This protocol is focused on collecting data, blood samples, and tissue~     on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts,~     pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise~     healthy controls.~      We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy~     coat are collected and stored according to strict SOPs.~   "
127099|NCT01392014|"~     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping~     malaria transmission.The addition of primaquine (PQ) - the only drug commercially available~     that kills mature transmission stage - to such treatments might be necessary to eliminate~     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine~     (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in~     Sumatra, Indonesia.~   "
127100|NCT01392001|"~     This observational study will evaluate the glucocorticoid sparing effect after 12 months of~     treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data~     will be collected for 12 months after the initiation of treatment with RoActemra/Actemra~     from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3~     months .~   "
127101|NCT01391988|"~     Prospective trial comparing post-operative complications and seroma formation after~     mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic~     scalpel.~   "
127102|NCT01391975|"~     Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of~     the blood vessels. Methods of detecting narrowing are available and, more importantly, can~     detect narrowings before a fistula fails. It is not known whether treating these narrowings~     will actually improve fistula survival or if the majority can be left alone. we wish to see~     if we can detect such narrowings with ultrasound scanning and if early detection and~     treatment improves patient outcomes.~   "
127103|NCT01391962|"~     Background:~        -  Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less~          than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients~          with metastatic ASPS. Little is known with regards to relevant molecular markers as~          potential therapeutic targets.~        -  Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF~          receptor tyrosine kinases, are showing preliminary evidence of activity in patients~          with ASPS.~      Objectives:~        -  Part I: Determine the objective response rate (ORR) of single-agent cediranib and~          single-agent sunitinib malate in patients with advanced ASPS.~        -  Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm,~          and determine the ORR of sunitinib in patients who progress on the cediranib arm.~        -  Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib~          and~      single-agent sunitinib malate in patients with advanced ASPS.~      Eligibility:~        -  Patients aged greater than or equal to 16 years with histologically or cytologically~          confirmed metastatic ASPS.~        -  Patients must show evidence of objective disease progression per RECIST 1 on scans~          within the 3-month period immediately preceding enrollment. Both scans used to~          determine disease progression should have been obtained within this 6-month period.~        -  Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show~          clinical evidence of disease progression will be eligible.~        -  Patients must not have received treatment with any VEGF receptor tyrosine kinase~          inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment~          with bevacizumab is allowed.~      Design:~        -  Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate~          (37.5 mg) orally, once a day in 28-day cycles.~        -  Part II: At the time of disease progression, patients will cross over to the other~          treatment arm after a 2-week wash-out period.~        -  Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles~          for restaging.~        -  The study will be conducted using an optimal two-stage design to rule out an~          unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high~          response rate of 40%.~      The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10~     patients has a clinical response, then no further patients will be accrued. If 2 or more the~     first 10 patients have a response, then accrual continues to a total of 22 patients in each~     arm.~   "
127104|NCT01391949|"~     This purpose of this study is to determine the effect of different levels of feedback on~     participation in a home exercise regimen and the amount of walking performed by patients~     recently discharged from the acute rehabilitation setting.~   "
127105|NCT01391936|"~     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon~     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence~     regarding the optimal treatment and outcome of these fractures with only one prospective~     randomized trial (1992) in the literature comparing tension band wire and plate fixation for~     displaced olecranon fracture. Our trial includes all patients under the age of 75yrs~     presenting to the Edinburgh Orthopaedic Trauma Unit with an isolated olecranon fracture~     requiring operative intervention. Patients who consent to enrol in the trial will be~     randomised to operative fixation using one of two recognised fixation techniques - tension~     band wire fixation or plate fixation. Patients will be evaluated over a one year period~     following their surgery.~   "
127106|NCT01391923|"~     This study is being performed to reduce unwanted fat in the arm using a new applicator for~     the Zeltiq System.~   "
127107|NCT01391910|"~     The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as~     measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the~     significance of response shift on treatment effect.~      This is a prospective cohort study. The investigators will recruit patients who are within a~     6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a~     pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20~     forms and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled pre~     and post operative. The pre should be completed based on subject's memory of their~     condition prior to surgery and post based on how they feel now.~   "
127140|NCT01391403|"~     This study will determine the effectiveness of artemisinin plus risperidone in improving~     symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study~     addresses the Toxoplasma infection hypothesis of schizophrenia.~   "
127108|NCT01391897|"~     This reported observational clinical study aims at identifying epigenetic markers in a~     sample of patients undergoing high dose inpatient psychotherapy suffering from a variety of~     psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress~     disorder (PTSD), depression, anxiety disorders and eating disorders.~      The exact epigenetic markers that will be traced are yet to define.~      The investigators believe that~        1. Epigenetic patterns found in the group of psychiatric patients show differences from~          healthy controls~        2. Different diagnosis show differences in epigenetic patterns as well~        3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured~          in interviews or psychometric ratings~        4. Epigenetic patterns can change under inpatient high dose psychotherapy~        5. Changes correlate to clinical psychometric variables.~   "
127109|NCT01391884|"~     The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is~     characterized by a severely impaired incretin effect. The incretin effect refers to the~     insulinotropic action of the nutrient-released incretin hormones glucagon-like peptide-1~     (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined~     as the difference in insulin secretory responses between oral and isoglycaemic intravenous~     glucose challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for~     as much as 70% of the insulin response following oral glucose, whereas patients with T2D~     exhibit an incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic~     patients with severe kidney failure share several pathophysiological characteristics,~     including decreased insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell~     function. The reason for these findings remains to be fully elucidated. An ongoing study in~     our research group is investigating the incretin effect and the incretin hormone secretory~     responses following OGTT, IIGI and meal ingestion, respectively. In continuation of this~     study, essential knowledge of metabolism of incretin hormones in an uremic milieu will be~     obtained in the present study prior to evaluation of the use of incretin-based agents in~     patients with impaired kidney function. In this second study we evaluate the elimination and~     biodegradation of GLP-1 and GIP. The biological active incretin hormones are rapidly~     degraded by the ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive~     metabolites. The active hormones are however also eliminated by renal clearance, although~     the importance of this remains questionable. It is likely that the degradation and~     elimination of the active hormones will be significantly affected in patients with severe~     kidney impairment.~      We hypothesize that elimination and biodegradation of the two incretin hormones, both in~     it´s active and inactive forms, will be affected in non-diabetic patients with severe kidney~     failure.~   "
127110|NCT01391871|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting~     stent in patients with acute coronary syndromes requiring percutaneous coronary~     intervention.~   "
127111|NCT01391858|"~     This study will compare the effects of oral pregabalin with placebo on postoperative pain~     and morphine usage after mastectomy.~      Pregabalin is an anticonvulsant agent approved by the United States Food and Drug~     Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic~     neuralgia and diabetic neuropathy.~      Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with~     axillary node dissection will be recruited to participate in the study. Patients unable to~     cooperative, those that have known allergy to pregabalin or morphine and a history of drug~     or alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or~     impaired kidney function will all be excluded from the study. A pregnancy test will also be~     performed to exclude pregnant women from the study.~      Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before~     surgery followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or~     placebo) will be administered twice daily until day 14. Whether a patient receives~     pregabalin or placebo will be decided based on a process similar to tossing a coin.~      Patients will receive a standard general anesthetic for their operation and will receive~     intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate~     postoperative period. Oral opioids will be administered after discontinuation of the PCA.~      Subjects will be visited after the operation while in the hospital and intermittently for~     three months at the outpatient clinic after discharge from the hospital. Subjects will be~     asked to return remaining study drug/empty container when they are at the hospital for their~     2 week follow up visit.~      Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema,~     weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side~     effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all~     patients for the occurrence of these side effects.~   "
127112|NCT01391845|"~     Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2)~     serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated~     serum P levels leads to an accelerated endometrial maturation which interferes with the~     dialogue between embryo and endometrium. It has been reported that serum progesterone levels~     ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing~     pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in~     the endometrial gene expression profile related to P elevated levels.~      Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial~     epithelium and its expression seems to be related to the action of P. Because glycodelin-A~     has immunosuppressive activity, it may facilitate the process of implantation and the~     maintenance of pregnancy.~      It is already know that ulipristal acetate (UPA) decrease serum P levels. The hypothesis of~     this study is that UPA is been able to modify P serum levels and glycodelin-A endometrial~     expression pattern on FSH/GnRH Antagonist cycles for FIV.~   "
127113|NCT01391832|"~     The objective will be to determine if adding repetitive transcranial magnetic stimulation~     prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal~     symptoms in individuals with combat related post traumatic stress disorder and improves~     clinical outcome.~      The investigators have assembled a multimodal human performance laboratory including 64~     channel EEG and repetitive transcranial magnetic stimulation system. These resources~     combined with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC)~     at UT Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used~     in this study.~      The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed~     by a 1 month, 3 month and 6 month follow-up appointments.~   "
127114|NCT01391819|"~     The aim of this study is to establish an active surveillance in order to generate dengue~     disease burden estimates including incidence rates, prevalence data, clinical presentation~     and cost of illness in Forteleza (Brazil).~   "
127115|NCT01391806|"~     The purpose of this prospective observational study is to evaluate the impact of~     preoperative breast MRI in patients with breast cancer selected for breast- conserving~     surgery. MRI is a more sensitive radiological modality than mammography and ultrasonography.~     Patients with small breast cancers are, based on conventional modalities, selected for~     breast-conserving surgery. If preoperative breast MRI reveal additional lesions in the~     breasts, and malignancy is confirmed histopathologically, this finding leads to a change of~     surgical method to mastectomy.~   "
127116|NCT01391793|"~     In this study the investigators will determine whether corticosteroids given at the time of~     urinary tract infection help prevent permanent damage to the kidneys.~   "
127141|NCT01391390|"~     This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on~     therapy to antipsychotics will be performed to examine the effects of melatonin on tardive~     dyskinesia symptoms and cognitive deficits in 120 patients with established tardive~     dyskinesia (TD). This study addresses a free radical hypothesis of TD.~   "
127117|NCT01391780|"~     Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence~     (SUI) and urgency urinary incontinence (UUI).~      Methods: 51 women were prospectively divided into two groups, according to the symptoms as~     SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number~     of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for~     which an urgent void could be voluntarily postponed), number of parity and vaginal~     deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated~     by 60-min Pad Test. Subjective [urine stream interruption test (UST), visual survey of~     perineal contraction and transvaginal digital palpation] and objective (vaginal manometry)~     evaluations of PFM were performed in all patients.~   "
127118|NCT01391767|"~     This study histologically evaluates sites grafted with NuOss XC using ridge preservation~     techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone~     mineral with self-expanding collagen) will be compared to sites grafted with NuOss~     particulate (bovine bone mineral).~   "
127119|NCT01391754|"~     The study is a field trial comparing the SafeCare family preservation model to a comparable~     usual care model for parents in child welfare. The study also compares two levels of service~     quality control.~   "
127120|NCT01391741|"~     People with disease (PD) tend to walk with short steps, decreased velocity, and increased~     stride time variability. Short steps and increased variability are related to greater fall~     risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked~     effects on gait in people with PD which is considered to reflect an impaired automaticity of~     gait.~      Objective: To investigate short and long term effects of high-volume walking with visual~     spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with~     Parkinson´s Disease (PD), compared with walking without VSC.~   "
127121|NCT01391728|"~     The purpose of the project is to formulate, implement and evaluate a new type of~     activity-orientated, evidence-based prevention programme to prevent fall injuries among~     elderly people. The question examined by the study is whether the intervention programme~     can:~        -  significantly reduce accidents and incidents involving falling among the participants,~        -  influence variables such as satisfaction with life, confidence in one's own ability and~          a feeling of involvement,~        -  be shown to be cost effective in terms of the use of resources. The intervention~          programme - Active lifestyle all your life - is being developed in and for primary care~          for the cost effective prevention of fall injuries among elderly people using a method~          that results in continued active life. The aim is to ensure that the elderly person is~          able to continue living an active life with commitment and involvement, which can in~          itself prevent fall injuries. This presupposes a knowledge of how to avoid fall~          injuries and the measures and aids that are available to prevent such injuries. The~          programme will also provide the participants with a social community in self-supporting~          groups which, by their own efforts but also with social support, are able to continue~          some of the activities provided through primary care.~   "
127122|NCT01391715|"~     To the best of our knowledge, there has been no randomized controlled trial to compare~     double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we~     hypothesize that a double dose PPI would accelerate and sustain the control of symptom in~     NERD patients.~   "
127123|NCT01391702|"~     When a woman requires a cesarean section after labour, anesthesia is usually provided by a~     pre-existing epidural. Occasionally, the epidural does not work. The anesthesiologist then~     may give a spinal anesthetic. The spinal space is identified by seeing cerebrospinal fluid~     (CSF) in the spinal needle. Rarely a spinal fails after a failed epidural as the fluid seen~     is epidural space fluid, not CSF. This study plans to use a bedside glucose monitor to~     measure glucose (sugar) in epidural fluid (compared to CSF) allowing the anesthesiologist to~     know the spinal needle is in the correct space.~      The investigators hypothesize that a bedside glucose measurement device can accurately~     quantitate the level of glucose within epidural space aspirate, and therefore could aid~     differentiation between CSF and epidural fluid.~   "
127124|NCT01391689|"~     This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to~     placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and~     be an effective treatment for breast cancer.~   "
127125|NCT01391676|"~     The aim of this study is imaging of trabeculectomy blebs regarding structure and function~     with the spectral domain optical coherence tomography.~   "
127126|NCT01391663|"~     The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of~     alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin~     in healthy Korean subjects.~   "
127127|NCT01391650|"~     The purpose of this prospective study is to evaluate the influence of both bundles on the~     knee stability - anterior-posterior translation, internal and external rotations after the~     double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability~     after single-bundle and double-bundle reconstruction using a computer navigation system.~   "
127128|NCT01391637|"~     The purpose of this study is to determine the long term safety and preliminary effect of~     HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).~   "
127129|NCT01391624|"~     The purpose of this study is to determine whether essential polyunsaturated acids (omega 3)~     are capable of reducing chocolate craving symptoms in healthy patients.~      Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize~     neuronal functioning in many conditions, including chocolate craving.~   "
127130|NCT01391611|"~     This study is being done to gather information about the safety (any harmful effects) and~     effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors~     (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug~     Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but~     it is not approved for the treatment of GIST. The investigators hope to learn about the~     safety and usefulness (effectiveness) of Pazopanib for patients with GIST.~      Primary Objective:~      Non-progression rate based on RECIST criteria (CR+PR+SD)~      Secondary Objectives:~        -  Response per Choi criteria~        -  6 month progression-free survival~        -  Safety and tolerability~   "
127178|NCT01390896|"~     The purpose of this study is to collect and assess information on safety and efficacy of~     fondaparinux in patients undergoing general surgery of the lower limb at high risk of~     developing venous thromboembolism.~   "
127132|NCT01391585|"~     The investigators are testing whether patients with diabetes can communicate with our health~     care system through text messaging. The investigators will look at how often they respond to~     prompts for blood pressures, blood sugars, and step counts. The investigators will also see~     if they come in for lab tests when prompted by text message. Also, for patients overdue for~     medication refills, the investigators will ask them why they have not yet called for the~     refill.~   "
127133|NCT01391572|"~     A randomized phase II trial to estimate the optimal radiation volume of postsurgical~     radiation for patients with locoregionally advanced thoracic esophageal squamous cell~     carcinoma (T3-4, any N, M0).~   "
127134|NCT01391481|"~     PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and~     biological properties, including high solubility of gas, swiftness of carrying and release,~     low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics~     in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor~     inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC~     vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung~     Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the~     Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation,~     objectively evaluate its curative effect on the acute respiratory distress syndrome, and~     meanwhile assess the safety of PFC.~   "
127135|NCT01391468|"~     This is a randomized double blinded placebo control studies are performed in Chronic Kidney~     Disease (CKD) patients. After informed consent, intervention group receives probiotics~     containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo~     group receives corn starch. In the first year the investigators examine the 60 peritoneal~     dialysis (PD) patients, in the second year the investigators do the 60 hemodialysis (HD)~     patients, and in the third year the investigators do the 60 stage 3 and 4 CKD patients.~     Primary endpoint is cardiovascular event, gastrointestinal symptoms, peritonitis in PD~     patients, and progression of stage 3 and 4 CKD. Values are compared between the groups by~     unpaired t test. X2 testis used to compare proportions between the groups. Relative risk and~     the number needed to treat, both with 95% CI, are used to describe the treatment effect of~     probiotics. A p value less than 0•05 is regarded as statistically significant.~   "
127136|NCT01391455|"~     There are in excess of 1 million operations performed annually to repair inguinal hernias,~     mostly in the male population. Unfortunately, some patients continue to suffer both groin or~     testicular pain for varying lengths of time postoperatively. This can lead to a severe~     degradation of the patient's lifestyle, work habits and sexual function. The origin of the~     pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also~     involves the spermatic cord and its structures, leading to orchidinia and possibly~     azospermia.~   "
127137|NCT01391442|"~     The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006~     families (4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for~     Preventive Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year~     periodic health examination, under the auspices of the Caisse Nationale d'Assurance Maladie~     (CNAM).~      This cohort was established with the primary objective of investigating gene-gene and~     gene-environment interactions in the field of cardiovascular diseases, based on the study of~     inter-individual variability and familial segregation analysis of biological and~     morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of~     this study should enable to take into account the evolution of intermediate phenotypes~     related to genetic factors throughout the follow-up period. The families, consisting of two~     parents and at least two biological children, were deemed healthy, free of declared acute~     and/or chronic illness, in order to assess the effect of genetics on the variability of~     intermediate phenotypes studied under physiological conditions (without the influence, in~     the absence) of pathology.~      The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial~     cohort of supposedly healthy subjects on such a large scale.~      Brief summary of ancillary study Cardiac Functional Indices Comparison Between MRI and~     Echocardiography : the ESCIF study is an ancillary study of the Stanislas cohort aiming at~     comparing in a cohort of supposedly healthy subjects different cardiac functional indices~     between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional~     indices have been recently developed in the scope of echocardiography and would be very~     useful in MRI. In echography they are computed either from tissue Doppler imaging or from a~     specific image analysis called speckle tracking. These two techniques are accessible in MRI~     with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which~     provides a motion model from which strains and strain rates may be derived and which allow~     longer acquisition without the constraint of breath holding (mandatory to reach high~     temporal resolution).~   "
127138|NCT01391429|"~     Subject preferences for care at the end-of-life show wide variability. In the setting of~     advanced disease, some subjects prefer all life-sustaining care while others forgo such~     procedures. The wide variability in preferences may be due to subjects' misconception of the~     disease condition when using solely verbal descriptions. The failure to participate in~     effective goals-of-care discussions may lead to overuse of medical interventions and~     life-sustaining measures that are inconsistent with patients' and families' wishes. Using~     video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds~     a sense of verisimilitude to the condition described and may better inform subjects when~     making their preferences.~      Specific Aim: To assess the effect of a video decision support tool on preferences for~     end-of-life care in patients and surrogate decision makers consulted on by an inpatient~     palliative care service. The investigators hypothesize that those subjects who view video~     images as a supplement to a standard palliative care consult will be more likely to opt for~     comfort oriented care.~      In this study, patient subjects and/or their healthcare proxies who are consulted on by an~     inpatient palliative care team will be surveyed regarding their preferences for end-of-life~     care following either a standard palliative care consult or one which utilizes a short video~     to complement verbal descriptions. The primary analysis will involve the proportion of~     patient subjects/proxies in each group that prefer comfort oriented care and that die in~     accordance with their stated preferences. The investigators will also study the effect of~     the video on patient subjects' and/or proxies' uncertainty with regard to treatment~     preferences and overall satisfaction with the palliative care consult.~   "
127139|NCT01391416|"~     It is well recognized that patients with chronic kidney disease (CKD) have an increased risk~     for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of~     future CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in~     patients with CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in~     Thai CKD patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK)~     study database and their relationship to CVD.~   "
130777|NCT01343888|"~     The objective of this trial is to evaluate the efficacy and safety of two different~     treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to~     standard of care (SOC) with PegIFN/RBV alone.~   "
127142|NCT01391377|"~     Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque~     formation in various arteries, causing narrowing of the artery and a limitation in blood~     flow. Depending on which artery the plaque is in, different clinical conditions occur. In~     adults common areas include in the heart arteries, in the neck arteries and in the aorta and~     lower leg arteries. When it affects the lower limbs it is known as peripheral arterial~     disease - PAD.~      The main symptom of PAD is called claudication and is described as pain or discomfort in~     the legs when walking. The aim of PAD treatment is to improve walking distance and quality~     of life in those with intermittent claudication, and to decrease long term complications~     including illness and death.~      An important controlling factor of these cholesterol plaques is a type of cholesterol called~     HDL (High density lipoprotein).~      This study aims to look at the effect that raising HDL for a prolonged period has on blood~     markers of inflammation and on the cholesterol plaque composition in patients with PAD. This~     investigation will also have relevance to the effects of HDL elevation on plaque composition~     and inflammation in other areas of the body including the heart, neck and brain arteries.~      Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate~     recruitment of all 20 patients within 12 months. The 20 PAD patients all must have~     significant leg pains when walking, and after review by a doctor, be determined to have~     narrowings in the leg artery that they will plan to operate on. Patients will be randomized~     to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation)~     After the 8 week period they will then go on to receive the normal interventional treatment~     as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to~     surgery. The plaque that is removed at the time of operation will also be sent to the lab~     for analysis.~      The investigators hope to show with this study that by raising the levels of HDL with~     extended release niacin, there are positive effects on the amount of cholesterol in the~     plaque, and on the markers in the blood of inflammation and thrombosis.~      The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions~     including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced~     monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition~     of thrombotic markers.~   "
127143|NCT01391351|"~     In order to search for predictors of response to chemotherapy in patients with ovarian~     carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will~     define the comparative profiles of miRNA expression of serum polymorphisms and determine~     differential in 2 patient populations (with or without recurrence 6 months after completion~     of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii)~     identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes~     involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles~     will also be studied during the first course in response to chemotherapy. Indeed, the miRNA~     profile of serum may be different at baseline among the 2 types of populations (or~     non-recurrence at 6 months).~   "
127144|NCT01391338|"~     In this study several doses of ASP3652, given orally for 12 weeks, will be compared with~     placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic~     Pain Syndrome.~   "
127145|NCT01391325|"~     This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the~     safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy~     (ULT) for up to six months. Allopurinol will be dosed according to the local product label,~     at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for~     each patient.~   "
127146|NCT01391312|"~     This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in~     glabellar rhytides (frown lines) using a new treatment satisfaction measure.~   "
127147|NCT01391299|"~     This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo~     for the treatment of forehead lines (facial rhytides) when also administered to frown lines~     (glabellar rhytides).~   "
127148|NCT01391286|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with~     vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy~     treatment.~   "
127149|NCT01391273|"~     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with~     vehicle in Japanese adults with hypotrichosis of the eyelashes.~   "
127150|NCT01391260|"~     The purpose of this study is to access the effect and safety of radiotherapy combined whth~     Iressa for patients with locally advanced non-small cell lung cancer with harboring active~     EGFR mutations.~   "
127151|NCT01391247|"~     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Up~     until today, very little is known about the metabolic alterations in the retina of glaucoma~     patients, since only techniques for surrogate measurements of metabolism (like blood flow~     velocities and vessel diameter) were available. Oximetry has provided us with an important~     tool to study metabolism in glaucoma, and to correlate these findings with the available~     blood flow evaluation techniques. Preliminary results by the group of Prof Stefánsson (2011)~     with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects~     are associated with decreased arteriovenous differences in retinal oxygen saturation. These~     data suggest that a change in oxygen metabolism occurs in glaucomatous retina. This reduced~     oxygen metabolism may be related to tissue atrophy. However, this explanation is still~     hypothetical, since the relation between these oximetry results and structural changes in~     the optic nerve have not been studied yet.~        1. What are the oximetry values in a normal population of within the same age group as the~          glaucoma population? To answer this question, a normative database of the investigators~          retinal oximetry device needs to be constructed for healthy controls.~        2. Do glaucoma patients have different retinal oximetry values than these normal patients?~          Are there any differences in retinal oxygenation between these glaucoma groups? To~          answer these questions, oximetry measurements will be performed in patients with normal~          tension glaucoma (NTG) and primary open angle glaucoma (POAG).~        3. Is there an association between structural optic disc and retinal nerve fibre layer~          changes, using Heidelberg Retinal Tomography (HRT), with alterations in retinal~          vascular oxygen saturation in NTG and POAG patients?~        4. Are blood flow measurements, using colour Doppler imaging (CDI), correlated with~          alteration in retinal vascular oxygen in NTG and POAG patients?~   "
127152|NCT01391234|"~     The purpose of this research study is to evaluate the safety and effectiveness of an~     experimental workflow that may result in a faster way to plan and deliver radiation for the~     treatment of pain caused by metastatic bone tumors (tumors that originally came from another~     organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that~     begins in white blood cells that produce antibodies).~      The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks~     from start to finish. The investigators have developed an experimental workflow: a radiation~     treatment planning and delivery workflow called STAT RT (STAT means right away, and RT~     means radiation therapy). This experimental workflow may shorten the time it takes to plan~     and treat painful bone metastases to 1 week or less. All steps in this process will be~     performed within the current standard of care but in a shorter time frame to allow treatment~     to start sooner.~      The investigators will evaluate effectiveness by requesting patients to complete pain and~     quality of life questionnaires before and after treatment. The investigators will also be~     collecting additional information from their treatments that will help us make future~     workflows even more efficient.~   "
127153|NCT01391221|"~     Major depression is accompanied by cognitive changes as well as alterations in multiple~     physical functions. The inflammatory system is altered generally toward a pro-inflammatory~     state. Antidepressants are associated with a decrease in this proinflammatory state. This~     study aims to generate pilot data concerning a possible link between cognition, inflammation~     and response to treatment. The cognitive function of subjects with major depression will be~     tested before and after treatment with duloxetine. Inflammatory markers will be measured at~     both time points.~   "
127154|NCT01391208|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are~     very good, but if the area doesn't look different to the naked eye, then the endoscope can't~     improve on that. The investigators are looking at using special fluorescent stains in~     addition to special endoscopes designed to see abnormal areas that are not obvious to the~     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical~     laboratories but it takes several days of processing to get results. It may be very helpful~     to look for areas to sample for abnormal tissue during the endoscopy procedure.~      You are being asked to let us use fluorescent peptides with a special endoscope that allow~     us to see of your esophagus with both fluorescent and white light during your upper GI~     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids~     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7~     amino acids attached to a fluorescent dye called FITC (like the one used by your eye~     doctor).~      The investigators have prepared special fluorescent peptides, that will glow when a~     special light is used that should help us separate normal tissue from abnormal tissue. In~     this study, the investigators will apply the special fluorescent peptides by a spray~     catheter to your esophagus to help us target you biopsies. Both routine and targeted~     biopsies will be taken as your endoscopist feels is indicated.~      This is a phase 1 study. This means that this is the first time the investigators have used~     this kind of fluorescent peptide in people. The Food and Drug Administration (FDA) has not~     approved this agent, but is allowing us to test it in this study. The main goal of this~     study is to see if there are any side effects from using the peptide. Our second goal is to~     see if the peptide glows well and if the investigators can take pictures of the areas that~     do glow.~      This is the first test of this agent, so it won't be used to change how your biopsies are~     taken nor how your endoscopy is done.~   "
127155|NCT01391195|"~     The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of~     young women submitted to chronic endurance training program associated to low level laser~     therapy when compared to chronic aerobic training alone.~   "
127156|NCT01391182|"~     You are being asked to take part in this research study because you are scheduled to have~     total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the~     effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for~     patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug~     Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA~     to prevent bleeding during and after surgery; use of this drug as a means of preventing~     bleeding is not currently approved by the FDA.~   "
127157|NCT01391169|"~     This is a control matched prospective study evaluating the use of seromuscular flap for high~     risk anastomoses.~   "
127158|NCT01391156|"~     The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil~     with 0.1% Finasteride lotion for 6 months in male pattern hair loss.~   "
127159|NCT01391143|"~     The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV)~     infusion to patients with refractory cancer. The study will also evaluate how long MGA271~     stays in the blood and how long it takes for it to leave the body, what is the highest dose~     that can safely be given, and whether it may have an effect on tumors.~   "
127160|NCT01391130|"~     To compare the progression free survival of LY2510924 plus sunitinib therapy versus~     sunitinib in the first-line setting for patients with metastatic clear-cell renal cell~     carcinoma.~   "
127161|NCT01391117|"~     The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected~     participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the~     body, how it is distributed within the body and removed from the body over time) and~     antiviral activity of repeated doses of TMC649128 given as monotherapy and given in~     combination with pegylated interferon + ribavirin. We assess the~     pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD)~     relationship for antiviral activity, active metabolite and safety of TMC649128 and its~     metabolites. We determine the short term safety and tolerability of the co-administration of~     TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in~     treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated~     interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for~     14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a~     preliminary way the short term antiviral effect of the combination of TMC649128 with~     pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1~     HCV-infected participants.~   "
127162|NCT01391104|"~     Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in~     pulmonary vascular resistance leading to shortness of breath and exercise intolerance.~     Exercise capacity has been used as the primary endpoint in most recent randomized controlled~     trials evaluating PAH-specific therapies as it correlates with functional class and survival~     in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However,~     there is commonly some discrepancy between significant clinical improvement and minor~     changes (generally <10% from baseline) in 6WMT following therapy. Because important clinical~     decisions are based on patients' functional capacity, a reproducible and sensitive exercise~     test is needed in PAH. The aim of this study was to compare the reproducibility and the~     responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance~     test (CET) following pharmacological therapy in this disease.~   "
127163|NCT01391091|"~     The purpose of this prospective study is to evaluate the effect of catheter ablation on~     incidence, prevalence and disease-severity of migraine in AF patients undergoing ablation,~     with or without a history of migraine.~   "
127164|NCT01391078|"~     This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF)~     continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma~     patients. There are two control measurements: The GAT/Perkins profile in the same eye in the~     second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore,~     each eye serves as test eye and also as control for the second test eye.~   "
127165|NCT01391065|"~     The proposed two stage study will evaluate patterns of local recurrence after EBRT and~     brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in~     patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The~     first stage of the study will focus on developing MR guided interstitial brachytherapy and~     validating the concept of high risk gross tumor volume (on the basis of functional imaging~     features).~      The second stage thereafter will focus on developing biologically modulated interstitial~     brachytherapy.~      In the proposed two staged study the investigators intend to prospectively evaluate and~     validate concept of HRGTV and develop technique of biologically dose modulated~     brachytherapy. The demonstration of technical feasibility and clinical safety of~     biologically modulated image guided radiotherapy in this pilot study for may pave the way~     for improving local control in patients with postoperative recurrences.~   "
127166|NCT01391052|"~     Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side~     effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy~     menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of~     post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively~     slough the endometrium prior to insertion of the LNG IUS.~   "
127167|NCT01391039|"~     This is a pilot study designed to investigate new techniques to guide the appropriate~     diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and~     stiffness of the lesion may be prognostic factors that can guide the need for more or less~     extensive therapy or perhaps only imaging follow-up may be needed.~   "
127168|NCT01391026|"~     Patients who have advanced or multiple chronic illnesses present management difficulties for~     primary care providers. Acute medical issues and limited time for patient evaluation can~     complicate complete assessment of physical symptoms that directly impact a patient's quality~     of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness~     Management Clinic to provide care for complex patients. Patient entry into the Advanced~     Illness Management Clinic is by referral only, a passive process. After discharge, general~     medicine clinic patients who do not have a medical provider are given an appointment in the~     clinic. Since the hospital is the source of many patients, this guarantees that these~     patients will have at least one illness advanced enough to require hospitalization, and most~     will have additional chronic illnesses. An outpatient palliative care clinic located in a~     specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the~     benefits realized by hospital patients, for whom palliative care consultation has been~     available for many years, to patients cared for in the outpatient setting. The benefits~     provided include physical symptom management, spiritual counseling, and support for social~     issues. Until recently, this outpatient palliative care model has mainly served patients~     with malignancy. With the addition of the Advanced Illness Management Clinic, palliative~     care clinicians now can provide care to patients with other chronic and serious illness in~     the primary care setting.~      Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden~     if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a~     general medicine clinic.~   "
127169|NCT01391013|"~     The purpose of this study is to compare change of brachial artery flow mediated~     vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use~     of a single medication) versus a triple combination therapy containing 2 nucleoside reverse~     transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1)~     infected participants.~   "
127170|NCT01391000|"~     The purpose of this study is to evaluate the most effective method between Transcutaneous~     Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy~     carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients~     treated with reconstruction of the rotator cuff.~   "
127171|NCT01390987|"~     Prompt access to care and treatment adherence are the hearth of tuberculosis control.~      This is a multicentre observational prospective study aimed at studying the factors~     associated with delayed access to care and low adherence to anti-tuberculosis treatment.~     Hetero- and self-administered questionnaires will be used at enrollment to assess clinical~     presentation and time and modalities of the diagnosis. Treatment adherence will be assessed~     during the follow-up with self administered questionnaires.~   "
127172|NCT01390974|"~     To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows~     to select adequately one of the 2 antiplatelet treatments approved in the same indication~     (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar~     levels of platelet inhibition with the 2 different thienopyridines suggesting optimal~     risk/benefit ratio in most patients with individualized therapy.~   "
127173|NCT01390961|"~     Comfort is compared between two allergy drops~   "
127174|NCT01390948|"~     This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety,~     tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy~     with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant~     and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically~     confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or~     infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be~     randomly assigned to one of two treatment arms.~      Upon approval by the Health Authorities/Ethics Committees in the participating countries, an~     additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with~     progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem~     WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive~     bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is~     over 1 year.~   "
127175|NCT01390935|"~     The purpose of this study is to survey the guideline compliance of the cardiologists in the~     treatment of systolic heart failure in Korea~   "
127176|NCT01390922|"~     The objective of this post-marketing surveillance study is to collect safety, efficacy and~     usage data on botulinum injection in subjects with upper or lower limb spasticity on the~     long-term use in clinical practice and to identify the factors affecting the safety or~     efficacy.~   "
127177|NCT01390909|"~     Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;~     however, complete seizure control remains elusive for many patients. Uncontrolled or~     refractory epilepsy is associated with a higher risk of mortality, physical injuries, and~     depression or anxiety compared with patients with controlled epilepsy. Higher resource~     utilization for patients with poor control is likely to be associated with higher economic~     costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,~     recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one~     seizure per month and 2.) a history of drug failures.~      The objective of this study is to identify patients with uncontrolled epilepsy in both a~     Medicaid database and a private health plan database, to describe patient characteristics~     and AED treatment patterns between cohorts of patients with uncontrolled versus~     well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus~     well-controlled epilepsy.~      For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases~     from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second~     quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter~     1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and~     medical and pharmacy claims in an private health plan database.~      The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient~     records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy~     (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1~     epilepsy-related inpatient or emergency department (ED) visit within 365 days),~     well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits),~     and intermediate epilepsy (not classified as uncontrolled or well-controlled).~   "
127180|NCT01390870|"~     Patient-based surveys will be conducted to evaluate the drivers of medication adherence in~     patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB)~     therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will~     be evaluated. The researchers believe that the majority of participants will report that~     they are compliant with therapy. The data source is a cross-sectional patient survey~     administered at one time point.~   "
127181|NCT01390857|"~     The purpose of this post-marketing surveillance study is to collect and assess information~     on safety and efficacy of valaciclovir in pediatric patients with chickenpox~   "
127182|NCT01390844|"~     This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron~     (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared~     to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C~     (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia~     Pacific population. The primary hypothesis is that the proportion of participants achieving~     sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior~     to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.~   "
127183|NCT01390831|"~     The purpose of this study is to determine whether renal denervation is safe and effective in~     the treatment of Chinese patients with uncontrolled hypertension.~   "
127184|NCT01390818|"~     This research trial is testing a combination of two experimental drugs, MSC1936369B~     (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and~     SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR)~     inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary~     purpose of the study is to determine the maximum tolerated dose of the drug combination.~   "
127185|NCT01390805|"~     The purpose of this study is to collect and assess information on proper use of valaciclovir~     regarding safety and efficacy of long-term use in suppressive therapy for subjects with~     recurrent genital herpes.~   "
127186|NCT01390792|"~     The purpose of this post-marketing surveillance study is to collect information on efficacy~     and safety for prophylactic administration of zanamivir in clinical practice in family or~     persons living with patients with influenza virus infection.~   "
127187|NCT01390779|"~     The objectives of this study are to assess the safety and effectiveness of the SENSIMED~     Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular~     pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of~     continuous TF recording.~      TF efficacy will be evaluated by demonstrating TF ability to detect:~        1. The known phenomenon of increase in IOP when moving from waking state to going to bed,~          as reflected in pneumotonometer measurements~        2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).~      A screening visit and one 24-hour IOP fluctuation recording session are planned for each~     patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An~     ophthalmological examination of the eyes will be done at screening and prior to and~     following the device recording.~   "
127188|NCT01390766|"~     This post-marketing surveillance (PMS) study is designed to investigate the efficacy and~     safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.~   "
127189|NCT01390753|"~     Acute respiratory infections are the leading cause of hospitalization in premature infants~     worldwide. Severity rates are particularly high in developing countries. Numerous viruses~     can cause severe disease, but the most frequent agent of hospitalization is respiratory~     syncytial virus (RSV). In a recent study in Argentina, 58% of RSV infected VLBW infants~     required hospitalization and 19% required mechanical ventilation. One every twenty infected~     infants died. Unlike industrialized nations, VLBW infants in developing countries often lack~     access to prophylaxis against RSV with a commercially available monoclonal antibody~     (palivizumab). No vaccine or preventive intervention is available against any respiratory~     virus for infants younger than 6 months of age in developing countries and the public sector~     of most middle-income countries.~      The protective role of breastfeeding against respiratory infections in developing countries~     is well established. But while similar beneficial effects have been described for premature~     infants, the dropout rate for breastfeeding in families exposed to the uncertainties and~     stress of the early months of life in the neonatal intensive care unit is very high. The~     World Health Organization recommends the use of Human Milk Donor Banks to feed infants that~     cannot be breastfed by their own mothers. These banks are established with the purpose of~     collecting, screening, processing (including pasteurizing), testing and distributing donated~     human milk. The potential benefit of donated milk against acute disease elicited by RSV is~     unknown. The investigators propose to study the role of supplemental donated human milk in~     the prevention of hospitalizations caused by RSV in non-breastfeeding premature infants.~     Since the investigators expect the benefits of breast milk to extend beyond protection~     against RSV, the effect of human milk against respiratory infections elicited by other~     viruses will also be evaluated.~   "
127190|NCT01390740|"~     Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (> 3 cm) in patients with~     echocardiography (transthoracic or) during a specific day, with cardiologists in France.~      This is a cross-sectional epidemiological investigation, assembling evidence from a routine~     ultrasound screening for AAA at the waning of echocardiograms performed during a specific~     day.~      The study will be offered a list of centers selected by the Scientific Committee in the~     complete list of locations being in France, the subsidiary of echocardiography~     Echocardiography of French Society of Cardiology. These centers will be 500 in number~     representative of the French centers, geographically and by type of centers.~   "
127191|NCT01390727|"~     Hypertension is a chronic disease that affects about 23% of the brazilian population. The~     treatment of hypertension by pharmacological intervention is efficacious, but has side~     effects and significant costs. Techniques that reduce the respiratory rate are shown as a~     effective non-pharmacological treatment in controlling blood pressure. Evidence has shown~     that a slow and deep breathing rate, around 10 breaths per minute or less, significantly~     reduces blood pressure. However, the physiological mechanisms involved in blood pressure~     decrease due to decreased respiratory rate are not yet known. Therefore the goals of this~     study will evaluate the chronic effect of breathing exercise guided on office and 24 hours~     blood pressure and analyse the chronic effect of breathing exercise guided over the~     autonomic function in hypertensive patients in stages 1 and 2.~   "
127192|NCT01390714|"~     The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics~     of E3710 following oral administration to Healthy Male Japanese Subjects~   "
127193|NCT01390701|"~     The purpose of this study is to compare the blood pressure reducing property of~     transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.~   "
127451|NCT01387321|"~     In this study, BYL719 will be administered to adult patients with advanced solid tumors~     whose disease has progressed despite standard therapy or for whom no standard therapy~     exists. The trial will investigate the safety and tolerability and determine the MTD of~     BYL719 in Japanese patients.~   "
127194|NCT01390688|"~     Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction~     followed by dementia in late life. Obesity, physical inactivity and systemic low-grade~     inflammation are strong risk factors and play a crucial role in this network of diseases.~      Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues~     outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity~     and type 2 diabetes.~      The investigators include 200 individuals divided into three groups: 80 individuals with~     type 2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose~     tolerance.~      The project will test the hypothesis, that low systemic BDNF are associated with~     accumulation of abdominal fat, cognitive dysfunction and insulin resistence with different~     effect in men and women.~   "
127195|NCT01390675|"~     In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is~     an emerging procedure for high-risk patients that are assumed to be otherwise inoperable.~     The investigators want to evaluate the specific intraoperative anesthesiologic~     characteristics cardiac anesthesiologists have to face during these procedures.~   "
127196|NCT01390662|"~     The purpose of this study is to investigate whether patients with depression should be~     offered vitamin D supplements, or it has no significance in relation to treatment outcomes.~   "
127197|NCT01390649|"~     It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not~     known in detail. The primary objective of this study was to investigate the specificity of~     antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP)~     who have shown signs of clinically relevant hemolysis following treatment with the~     intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of~     hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish~     between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an~     independent adjudication by a committee was performed for each patient with signs of~     hemolysis determined in the laboratory or in the clinic.~      This study was requested as a post-marketing commitment study by the United States Food and~     Drug Administration (FDA). By September 2014, no case of clinically significant~     intravascular hemolysis was found, and the FDA agreed to halt the study and analyze all~     hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses~     planned in the protocol. The study was not restarted.~   "
127198|NCT01390636|"~     The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to~     determine the degree of variation in glucose levels of individuals with an eating disorder~     and type 1 diabetes and only an eating disorder.~   "
127199|NCT01390623|"~     Urinary tract community infections are one of very frequent reason consultation and~     prescription. Urinary tract represents the second site of bacterial community infection~     after the respiratory system. The management of the acute uncomplicated pyelonephritis was~     simply codified in the past recommendations of the French Agency for Safety Health Products~     (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones~     with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.~      The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally~     provides a simplified treatment for patients, a reduced use of fluoroquinolones and a~     probable decrease in correlation with the emergence of fluoroquinolones resistance, and~     finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.~   "
127200|NCT01390610|"~     The purpose of this study is to use data from the Continuous Glucose Monitoring (CGM) device~     and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test~     blood glucose levels using SMBG.~   "
127201|NCT01390597|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors find better ways to treat the cancer.~      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with~     peripheral T-cell lymphoma or natural killer cell neoplasms.~   "
127202|NCT01390584|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate,~     vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride,~     vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses~     high-energy x rays to kill cancer cells. Giving combination chemotherapy together with~     radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such~     as PET scans and CT scans, done before, during, and after chemotherapy may help doctors~     predict a patient's response to treatment and help plan the best treatment.~      PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan~     works in treating patients with stage I or stage II Hodgkin lymphoma.~   "
127203|NCT01390571|"~     RATIONALE: Olaparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Olaparib may help temozolomide kill more tumor cells by making tumor cells more~     sensitive to the drug.~      PURPOSE: This phase I trial is studying the side effects and best dose of olaparib and~     temozolomide in treating patients with relapsed glioblastoma.~   "
127204|NCT01390558|"~     This is a research study of persons with Down Syndrome between 2 and 80 years old who are~     independently walking. The purpose of this study is to see what effect orthotics have on how~     people with Down Syndrome walk.~   "
127205|NCT01390545|"~     This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm~     parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of~     veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc)~     injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative~     veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on~     continued stable co-medication with methotrexate (MTX).~   "
127206|NCT01390532|"~     Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with~     advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not~     clinically improve with CRT. New LVD markers other than QRS duration are needed.~      Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated~     SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®,~     Ceasaria, Israel) to quantify LVD.~   "
127207|NCT01390519|"~     This is a Norwegian prospective registration, observational study of patients with advanced~     renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI)~     ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these~     patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.~   "
127208|NCT01390506|"~     After cardiac arrest and successful resuscitation it can happen that the brain function of a~     patient is impaired because the brain was without oxygen for a prolonged period of time.~     Several strategies have been studied to improve brain function after cardiac arrest. Cooling~     of the patients is routinely used today. The trace element selenium has several biological~     functions and is important for defense mechanisms against oxidative stress, which occurs~     after cardiac arrest and successful resuscitation. critically ill patients have low selenium~     blood levels. Therefore the investigators hypothesize that giving selenium after cardiac~     arrest and successful resuscitation might improve brain function.~   "
127209|NCT01390493|"~     The purpose of this study is to determine whether neurofeedback training can significantly~     reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and~     psychological well-being. The primary aims of this study include:~        1. To examine whether AN patients are able to control their alpha-activity through~          neurofeedback.~        2. To examine the effects of neurofeedback on symptomatology and personality variables in~          AN patients.~        3. To examine the long-term effects of neurofeedback in the treatment of AN.~   "
127210|NCT01390480|"~     In this placebo controlled study the investigators aim to investigate the effects of vitamin~     D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine~     and metabolic parameters.~   "
127211|NCT01390467|"~     Randomized study, double-blind, crossover, controlled versus placebo.~   "
127212|NCT01390454|"~     Our primary objective is to study the relationship between ultra sound data and the pain~     associated with tennis elbow.~   "
127213|NCT01390441|"~     This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808~     versus rituximab (MabThera® and Rituxan®) in participants with moderate to severe RA with an~     inadequate response or intolerance to methotrexate.~   "
127214|NCT01390428|"~     This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered~     to participants with mild, moderate or severe hepatic insufficiency (assessed by the~     criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy~     participants.~   "
127215|NCT01390415|"~     This study will evaluate whether losartan protects the kidney in hypertensive Type II~     diabetic participants with microalbuminuria.~   "
127216|NCT01390402|"~     The goal of this clinical research study is to learn if giving a kind of immune cell called~     natural killer (NK) cells after chemotherapy will improve the response to a stem cell~     transplant in patients with CML. The safety of this treatment will also be studied.~   "
127217|NCT01390389|"~     The investigators propose to study and compare measures of brain energy metabolism in~     geriatric bipolar individuals and healthy older adults. The investigators would also like to~     investigate changes in brain energy metabolites associated with CoQ10 administration in~     older bipolar individuals. Finally, resting state functional Magnetic Resonance Imaging~     (fMRI) will be conducted in order to explore frontal and limbic circuitry in geriatric~     bipolar disorder.~        -  Primary Hypothesis: Baseline beta NTP and NAA will be lower, and PCr and lactate higher~          in Geri BPD compared with older healthy controls~        -  Secondary Hypothesis: Changes in PCr and beta NTP will be demonstrated in Geri BD group~          challenged with CoQ 10.~   "
127218|NCT01390376|"~     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative~     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia~     (particularly clozapine-resistant) is still a difficult clinical issue at present. According~     to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have~     therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing~     agents.~      The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant~     treatment for clozapine-resistant refractory schizophrenia patients in a randomized,~     double-blind, placebo - controlled trial.~   "
127219|NCT01390363|"~     The purpose of this study is to determine whether contacting the parents of adolescents~     overdue for routine vaccines or contacting both the parents AND adolescents overdue to~     routine vaccines improves immunization rates as compared to usual care.~   "
127220|NCT01390350|"~     This is a multi-center double-blind placebo-controlled study to assess the efficacy and~     safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that~     neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's~     global assessment (a combined clinical symptom score) and inflammation markers. Following a~     baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections~     of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day~     7. Patients will then be eligible to enter the 16-week open-label phase and receive~     canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse~     of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals~     following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled.~        1. Amendment: After successful completion of the 16-week open-label phase patients will be~          eligible to enter a one-year open-label extension of the study. During this part of the~          study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be~          performed upon relapse of symptoms comparable to the 16-week open-label phase.~        2. Amendment: After successful completion of the 1-year open-label study extension~          patients will be eligible to enter another 3-year open-label extension. Patients will~          be scheduled at 3-month-intervals and Canakinumab dosing will be performed on an~          individual basis with optimized dosing intervals to ensure a constant low disease~          activity.~   "
127221|NCT01390337|"~     The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when~     combined with induction and consolidation therapy and as maintenance therapy following~     induction and consolidation.~   "
127222|NCT01390324|"~     The purpose of this study is to determine whether a fixed-dose combination of naratriptan +~     naproxen is effective compared each monotherapy for the acute treatment of migraine.~   "
127452|NCT01387308|"~     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.~   "
127223|NCT01390311|"~     This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the~     standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC~     includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or~     DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter~     the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD)~     while maintaining the anticancer effects.~   "
127224|NCT01390298|"~     The purpose of this study is to provide preliminary data for a Program Project Grant to the~     National Institutes of Health to examine specific explanations regarding identifying~     patients at risk for chronic pain after surgery and identifying mechanisms which may be~     altered to decrease this risk.~      This study will help investigators better understand chronic pain that develops after~     surgery. We are proposing to study different factors related to the surgical experience and~     factors in the environment to determine if any play a role in the development of chronic~     pain after surgery.~   "
127225|NCT01390285|"~     Background~      Central sensitization has recently been documented in patients with knee osteoarthritis. So~     far, the presence of central sensitization has not been considered as a confounding factor~     in studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee.~      Purpose~      First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to~     explore the prognostic value of central sensitization on the pain inhibitory effect of TENS~     in Oak patients.~      Methods~      Patients with knee pain due to OAk will be recruited through advertisements in local media.~     Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be~     measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and~     function will be assessed. Patients will be randomly allocated to one of two treatment~     groups (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and~     12 weeks.~      Discussion/ conclusion~      TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous~     fibers. The responsiveness of central pain-signaling neurons of OAk patients who are~     centrally sensitized may be augmented to the input of these electrical stimuli. This would~     encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a~     subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit~     from burst TENS.~   "
127226|NCT01390272|"~     This randomized clinical trial examines whether programs aimed at matching resources to~     patient hypertension (i.e. high blood pressure) control lead to greater reduction in~     systolic blood pressure (top number of blood pressure reading) than simply having~     maintenance phone calls in addition to usual care. Answering this question will provide~     important evidence concerning the overall goal of sustained long-term implementation of the~     disease management programs as part of patient aligned care teams in the Veterans Affairs~     and other healthcare systems.~   "
127227|NCT01390259|"~     In this protocol the investigators plan to demonstrate management of glucose using a modular~     insulin management system based on continuous glucose monitoring and targeted towards the~     avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The~     protocol is designed to challenge the insulin management system with meals and mild~     exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing~     metabolic state. This system is designed to both~        -  monitor the meal boluses of the patient and correct it in case of observed/predicted~          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and~          subjective knowledge of the meal amount, a precise understanding of the subject's day~          to day insulin treatment, continuous glucose monitoring, and past insulin injections;~        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past~          insulin injection.~      The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and~     compare glucose control performances under two treatments: standard vs. the new insulin~     management system. The protocol will include a total of 5 admissions per subject (3~     out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1~     and inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30~     minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending~     on the chosen treatment, each subject will be exposed to both studied treatments (repeated~     measure design). The order of treatment during the inpatient admissions will be randomized.~   "
127228|NCT01390246|"~     This is a prospective, double-blind placebo-controlled randomized controlled trial of the~     preliminary safety and efficacy of bupropion SR in combination with behavioral counseling~     for smoking cessation during pregnancy.~   "
127229|NCT01390233|"~     This study is designed to assess the effectiveness of a combination method of induction of~     labor using a urinary balloon catheter and prostaglandin gel.~      The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery~     rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed~     induction in the United States is rising. This has led to a renewed effort to examine the~     effectiveness of the varied methods of induction.~      The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel~     for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto~     Health Richland for a scheduled induction of labor will be offered enrollment in the trial.~     Patients who enroll in the study will be randomized into one of 3 study arms: urinary~     balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and~     prostaglandin gel. Randomization will be per sealed envelope from the locked nurse~     medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland.~     The investigator will be given the next sequentially numbered study randomization envelope~     by the patient's nurse. The randomization assignment will be unblinded to the patient and~     her physicians. If the patient is not in active labor 6 hours after initiation of the~     intervention, a standardized protocol of oxytocin will commence. Labor management will be at~     the discretion of the physician.~   "
127230|NCT01390220|"~     The purpose of this study is to examine the safety and effectiveness of USL261 for the~     outpatient treatment of seizure clusters.~   "
127231|NCT01390207|"~     The effect of altering the timing of hCG administration on the ongoing pregnancy rate in~     patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH)~     antagonists for in vitro fertilisation (IVF).~   "
127232|NCT01390194|"~     The purpose of this study to assess the image quality of the rapid MRI compared to the~     standard MRI.~   "
127233|NCT01390181|"~     The specific aims of this study are to:~        -  Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in~          individuals with bicuspid aortic valve and ascending aortic or aortic sinus~          measurements >40mm.~        -  Assess the effect on MMP levels during treatment with losartan, an angiotensin II~          receptor blocking agent.~        -  In the setting of losartan therapy for one year, evaluate the response of MMP levels in~          these patients, and clinical outcomes including effects on aortic growth rate~   "
127234|NCT01390168|"~     The purpose of this study is to determine whether tailored internet-administered cbt is a~     feasible treatment for anxiety disorders in clinical settings.~   "
127235|NCT01390155|"~     Esophageal electrocardiography (eECG) has important advantages compared to standard ECG~     recordings.~      Coronary artery disease leading to myocardial ischemia is very common and has potentially~     severe consequences for patients. To date, the investigators don't know the influence of~     ischemia on the eECG. The goal of the present study is to assess ischemic changes of the~     eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary~     angiography.~   "
127236|NCT01390142|"~     RIRE-1 is a randomized, open-label with blinded end-point study that will test the~     hypothesis that remote ischemic preconditioning initiated at the time of the admission in~     the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI)~     patients treated with percutaneous coronary intervention (PCI). Furthermore, it will~     determine whether a combined approach remote ischemic preconditioning and local ischemic~     postconditioning can further reduce infarct size. Infarct size will be determined by cardiac~     magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.~   "
127237|NCT01390129|"~     RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote~     ischemic preconditioning initiated before surgery reduces post-operative myocardial damage~     in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of~     troponin-I.~   "
127238|NCT01390116|"~     The purpose of this study is to determine whether consuming capsules of aged garlic extract~     is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu~     symptoms.~   "
127239|NCT01390103|"~     The purpose of this project is to determine the effect of hip injections on hip biomechanics~     in patients with hip pain.~   "
127240|NCT01390090|"~     Subjects will have failed conservative treatment, including, but not limited to oral~     medications, physical therapy, manual manipulation, and/or alternative medicine. They will~     be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics~     and will be scheduled for a piriformis muscle (PM) corticosteroid injection.~   "
127241|NCT01390077|"~     Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic~     acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia,~     for which it has been approved by the FDA.The objective of this research is to explore~     reported age related differences in toxicity of nitisinone and its pharmacokinetic~     underpinnings and to develop an optimal therapeutic requirement for a targeted population of~     presymptomatic patients. The additional effect of mixtures of amino acids excluding tyrosine~     will be explored to take advantage of protein synthesis to avoid elevations of tyrosine that~     would otherwise limit the optimal dosage of nitisinone. The study is designed to treat~     patients and find the optimal dosage of nitisinone to obtain maximal reduction in levels of~     homogentisic acid and maintain safe levels of tyrosine.~      The long term objective in the target population of pre-symptomatic patients is the~     prevention of the characteristic effects on joint cartilage and tendons.~   "
127242|NCT01390064|"~     Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon~     immunization of breast cancer subjects.~   "
127243|NCT01390051|"~     The purpose of the study is to investigate if treatment with an anticoagulant drug increases~     birth weight in pregnancies complicated by fetal growth restriction.~   "
127244|NCT01390038|"~     The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder~     System in total shoulder arthroplasty.~   "
127245|NCT01390025|"~     The purpose of this study is to compare the safety profile in healthy volunteers of a single~     intravenous administration of TCN-032 as compared with placebo.~   "
127246|NCT01390012|"~     The purpose of this study is to assess bioequivalence for dexamethasone administered orally~     versus intravenously in patients admitted to hospital for pneumonia.~   "
127247|NCT01389999|"~     The goal of this study is to carry out a transcultural validation of the Back Belief~     Questionnaire in order to assess its appropriateness for French-speaking populations.~   "
127248|NCT01389986|"~     Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer,~     paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function~     through the cephalic-vagal reflex and increased intestinal enzymes secretion.~      The objectives of this study are to evaluate effects of adding gum chewing to the~     conventional postoperative feeding protocol on the return of bowel function, its related~     complications, and patients' satisfaction.~   "
127249|NCT01389973|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients~     with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.~   "
127261|NCT01389804|"~     The overall long term objective of this research is to improve health care utilization and~     quality of life of pediatric solid organ transplant recipients and family. Understanding the~     process of transition to a chronic medical condition during the acute (3 weeks after~     transplant) and long term (3 and 6 months) will significantly guide the development of~     clinical interventions aimed at maximizing adherence and family psychosocial adjustment.~   "
127262|NCT01389791|"~     Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on~     muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the~     rocuronium-priming.~   "
127356|NCT01388569|"~     RATIONALE: Studying samples of blood from patients treated with sargramostim in the~     laboratory may help doctors learn more about the effects of sargramostim on cells. It may~     also help doctors understand how patients respond to treatment.~      PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV~     melanoma previously treated with sargramostim.~   "
127250|NCT01389947|"~     Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients,~     mesenteric ischemia appears even when macrocirculatory parameters are controlled especially~     in our experience in patients coming in ICU after a cardiac surgery. The investigators~     suppose that microcirculatory failure develops and results in suffering of non major organs~     like muscle, skin and digestive tracts. In this study the investigators monitor digestive~     tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT~     and plasma glycocalyx measurements. The population is composed by patients having coronary~     artery bypass during cardiopulmonary bypass.~      The first aim of this study is to show that digestive tract is suffering with the use of~     extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding~     Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will~     be less than 20 micromol/L.~      The second aim is to investigate link between endothelial dysfunction and digestive tract.~     Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after~     a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve,~     resaturation curve and hyperemic response by measurement of area under curve). Endothelial~     glycocalyx and NO pathway will be investigate (see under)~      Our objective is to enroll 100 patients. The same study will be done in a group of patients~     who benefit from coronary artery bypass without extracorporeal circulation to see the~     effects of extracorporeal circulation support.~   "
127251|NCT01389934|"~     Background: The use of local anesthetics as a supplement to conventional techniques in~     breast surgery is widely reported in the literature. Currently there is controversy~     regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The~     aim of this study demonstrate the efficacy of administering a local anesthetic into the~     surgical bed of women operated radical mastectomy for breast cancer for the control of~     postoperative pain.~      Material and methods: double-blind randomized clinical trial. The investigators recruited~     patients who underwent modified radical mastectomy that met inclusion and exclusion~     criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours,~     and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local~     anesthetic and rescue medication was identical in both groups.~      Statistical analysis: The baseline patient characteristics of the patients were analyzed by~     Chi square or Student t always meet criteria of normality, otherwise it will use the~     Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse~     events will be held on chi-square test.~   "
127252|NCT01389921|"~     The purpose of this study is to investigate afferent and cortical activities during bladder~     filling under different stimulations of the lower urinary tract. The participants of the~     study are healthy test persons and patients with overactive bladder.~   "
127253|NCT01389908|"~     The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP)~     Depot in patients diagnosed with schizophrenia or schizoaffective disorder.~   "
127254|NCT01389895|"~     This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple~     dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will~     consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or~     matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to~     receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be~     initiated after enrollment of Cohort 1 (210 mg) is completed.~   "
127255|NCT01389882|"~     The purpose of this study is to test the hypothesis that neurally adjusted ventilatory~     assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of~     inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants~     in comparison with currently used standard ventilation (synchronized intermittent mandatory~     ventilation with pressure-support ventilation, SIMV+PSV).~   "
127256|NCT01389869|"~     Obesity is closely related to metabolic diseases and its prevalence is sharply increasing.~     However, there is no safe and effective treatment for obesity so far, the investigators need~     a breakthrough idea to curtail the constant threat of obesity. It has been recently~     demonstrated that emotional tears of women can modify sexual responses, one of basic~     instincts, in men. As appetite and food intake is another basic instinct, chemosignals from~     tears and plasma may modify appetite and eating behavior in humans.~   "
127257|NCT01389856|"~     The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled~     nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a~     supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its~     metabolites.~   "
127258|NCT01389843|"~     KorAHF is a multi-center registry (prospective cohort) for acute decompensated heart failure~     patients in Korea.~      The aim of this registry is to analyze several causes affecting prognosis and survival and~     to develop new strategies for managing acute decompensated heart failure.~   "
127259|NCT01389830|"~     Objectives:~      The primary objective of the research project is to investigate how declining health status~     influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with~     cancer and to examine if and how these preferences are modified by predisposing~     characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or~     provider-related characteristics (i.e., ethnicity, language used, provision of interpreters,~     or patient navigators). The specific aims are:~        1. To determine if declining functional status influences the end-of-life treatment~          preferences of older Latino Medicare beneficiaries with cancer.~        2. To determine if predisposing characteristics (i.e., acculturation, age, education,~          medical mistrust, perceived racism) and/or provider-related characteristics (i.e.,~          ethnicity, language used, provision of interpreters, or patient navigators) modify the~          association between end-of-life treatment preferences and declining health status in~          older Latino Medicare beneficiaries with cancer.~        3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries~          with cancer differ from those of older Medicare beneficiaries without cancer.~   "
127260|NCT01389817|"~     The overall objective of the proposed research is to test the hypothesis that Near-infrared~     Light-emitting Diode (NIR-LED) therapy will stimulate mitochondrial function, attenuate~     oxidative stress, and improve cell survival and vision in subjects with Leber's Hereditary~     Optic Neuropathy (LHON).~   "
127263|NCT01389778|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age~     women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease.~     The investigators have found a possible change in the DNA (genes of the body that encode all~     of our traits) that seems to be related to insulin resistance. In this study, the~     investigators will try to determine whether the change in the gene affects a woman's ability~     to respond to a common treatment for PCOS, metformin.~      These studies will uncover the change in a gene that might be one of the causes of PCOS.~     Discovering this gene will help better understand the diabetes and insulin abnormalities~     that are common in PCOS and will help us to better diagnose and treat PCOS to prevent the~     diabetes in these women.~   "
127264|NCT01389765|"~     This study will evaluate the effect of food on LY2216684. There will be 2 study periods each~     lasting up to 5 days. There will be at least 7 days between the two doses and a follow up~     will occur at least 7 days after the last dose. Screening is required within 30 days prior~     to the start of the study.~   "
127265|NCT01389752|"~     The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2~     occasions, once with activated charcoal and once without activated charcoal.~      The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects~     will be documented. There will be 2 study periods each lasting up to 5 days. There will be~     at least 7 days between the two doses and a follow up will occur at least 7 days after the~     last dose. Screening is required within 30 days prior to the start of the study.~   "
127266|NCT01389739|"~     Many authors have recognized the need to overcome the different barriers to continuity of~     cancer care, such as inadequate communication between specialists and family physicians~     (FP), insufficient information provided for the long-term follow-up care and difficulties to~     transfer back to FP the responsibility for cancer care at the end of treatments. This study~     aims to assess the effectiveness of a multi-faceted intervention to improve continuity of~     care for patients with lung cancer. Newly diagnosed lung cancer patients who have a FP will~     be randomly assigned to either the intervention group or to usual care and they will be~     followed at baseline, 3, 6, 9, 12, 15 and 18 months ( or until death for those with a~     survival of less than 18 months). The intervention comprises 4 components: 1) systematic~     appointments with FP at 3-month interval ; 2) transmission to FP of a standardized~     comprehensive summary before each appointment; 3) systematic transmission to the oncology~     team of patients' information resulting from FP visits; 4) development of a priority access~     to FP for cancer patients. In both groups, outcomes related to patients and to care~     processes will be measured at baseline and then after 3, 6, 9, 12, 15 and 18 months (or~     until death for those with a survival of less than 18months). Patients' principal family~     caregiver will be invited to participate to the study and they will complete questionnaires~     at baseline, at 6 months and at the end of the study. In addition, patients' FP will also be~     invited to complete a questionnaire at baseline and at the end of the study.~   "
127267|NCT01389726|"~     This study is a multi-site, four-year long clinical trial study in which several mental~     health interventions will be delivered to custodial grandmothers and then compared. The~     study will examine effects on the mental health of these grandmothers and the grandchildren~     they provide full-time care to in complete absence of the grandchild's birth parents.~     Grandparents from diverse racial, ethnic, and socio-economic backgrounds will be recruited~     to test for cultural differences in response to these interventions. This study is important~     because there is growing evidence that custodial grandchildren are at-risk for psychological~     difficulties due to neglect and abuse by birth parents, challenges to parenting faced by~     custodial grandparents, and limited access to needed services. This study is funded by the~     National Institute of Nursing Research, a division of the National Institutes of Health, and~     it is anticipated that more than 500 custodial grandfamilies in four sites across the United~     States will partake.~   "
127268|NCT01389713|"~     Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still~     represent a demanding challenge for clinicians. It has classically been claimed that using~     higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to~     hyper-simulation and increase the chances of success. However, scientific evidence~     supporting this view is scanty and costs are inevitably much higher. In this study, the~     investigators hypothesized that similar chances of pregnancy may be achieved with a mild~     stimulation using exclusively Clomiphene citrate (CC).~   "
127269|NCT01389700|"~     Primary Objective:~      - To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356~     administered to intensive care unit (ICU) patients on mechanical ventilation~      Secondary Objectives:~        -  To determine the safety and tolerability of SAR279356~        -  To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356~        -  Exploratory efficacy of SAR279356 on prevention of bacterial infections~   "
127270|NCT01389687|"~     The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose~     primary and booster vaccination in Japanese infants aged 3 through 68 months.~      Primary objective:~        -  To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90%~          approximately one month following the three dose primary vaccination series with~          inactivated polio vaccine (IPV).~      Secondary objective:~        -  To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine~          response rates and Geometric Mean Titers) of IPV before and after the primary~          vaccination and before and after the booster vaccination.~        -  To describe the safety after each dose of IPV.~   "
127271|NCT01389674|"~     The investigators will check the feasibility of an intraprocedural vitality diagnostics and~     the identification of an indication for Percutaneous transluminal coronary angioplasty~     (PTCA).~   "
127307|NCT01389206|"~     This program intends to improve the management of pulmonary arterial hypertension (PAH)~     patients through an evidence-based approach aimed at achieving optimal World Health~     Organization (WHO) functional class (FC): 1. Improving FC III & IV patients to FC II, 2.~     Improving FC II patients to FC I, and 3. Maintaining FC II & FC I patients.~   "
127453|NCT01387295|"~     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second~     week in combination with systemic capecitabine and in patients with a HER2-positive tumour~     in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases~     from breast cancer.~      Only patients with limited extrahepatic disease are included.~   "
127272|NCT01389661|"~     This trial pretends to validate for clinical use a bioengineered product composed of MSV~     cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved~     by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked~     matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/~     119855) for bone maxillary cysts refilling. These two groups collaborate in the present~     project with the team of Maxillofacial Surgery of the Hospital Universitario del Río~     Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial~     is based on positive results obtained in previous animal studies performed by the present~     multidisciplinary team. The investigators propose a phase I / II clinical trial with 10~     patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem~     cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and~     cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity~     filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at~     3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and~     computerized tomography scan.~   "
127273|NCT01389648|"~     The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in~     addition to the usual care given after major abdominal surgery, in the prevention of~     post-operative respiratory complications.~   "
127274|NCT01389635|"~     Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among~     the most hazardous aesthetic procedures currently performed. It was shown, in many studies,~     to be associated with a significant complication rate, some of which are life-threatening.~     This study describes the investigators experience with a series of abdominoplasties~     performed under epidural anesthesia. Outcomes are presented, especially in terms of~     complication, and the practical advantages of this method are discussed.~   "
127275|NCT01389622|"~     Auricular acupressure has been practiced in China and Germany to help people in smoking~     cessation programs. The purpose of this clinical trial is to test for the clinical~     effectiveness of self-administered auricular acupressure as a non-invasive method for~     smoking cessation.~   "
127276|NCT01389609|"~     To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water~     to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition~   "
127277|NCT01389596|"~     Study A0081041 is a double blind, placebo controlled, randomized, parallel group,~     multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin~     administered in equally divided daily doses, in either capsule or oral liquid formulation,~     as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset~     seizures.~   "
127278|NCT01389583|"~     A Phase II Study of AUY922, Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or~     Intolerance of Imatinib and Sunitinib Therapy~      Primary endpoint:~      •The primary endpoint of this study is to assess disease control rate (complete response +~     partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed~     to imatinib and sunitinib~      Secondary endpoints:~        -  To determinate the objective response rate (ORR, complete response + partial response)~        -  To determinate the time to tumor progression (TTP)~        -  To evaluate the safety and toxicity profiles of AUY922~        -  To evaluate the pharmacokinetics profile of AUY922 in Taiwan GIST population~        -  To access the pharmacodynamic effect of AUY922 on HSP client proteins in blood and~          tumor if feasible , i.e. HSP70, in Taiwan GIST population~        -  To access the tissue biomarkers pre-treatment and 4wks post treatment if feasible, i.e.~          HSP70, c-KIT, PDGFRA mutation, ...etc in Taiwan GIST population~      Exploratory endpoints:~      •PET imaging; sSUVmax~   "
127279|NCT01389570|"~     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.~     However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would~     therefore be appropriate to consider the use of non-pharmacological methods in preventing~     PONV. Acupuncture and acupressure are reported to be effective preventive treatment for~     PONV, and the adverse effects are minimal. Consequently, the aim of the study is to~     implement acupressure in our anaesthetic department procedures. A reduction of the use of~     antiemetics will be a parameter on the effectiveness of acupressure. The study will focus on~     acupressure as a supplement to the ordinary prophylactic treatment of PONV in adults~     undergoing orthopaedic and general surgery, and adults and children undergoing ear, nose,~     throat surgery. The primary endpoints are the quantities of antiemetics used before~     (baseline) and during the implementation period. The study will be conducted from January to~     December 2011.~   "
127280|NCT01389557|"~     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping~     malaria transmission. The addition of primaquine (PQ) - the only drug commercially available~     that kills mature transmission stage - to such treatments might be necessary to eliminate~     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine~     (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing,~     Lampung, Sumatra.~   "
127281|NCT01389544|"~     This multicenter, open-label study will assess the effect of multiple doses of~     danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable~     methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive~     danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.~   "
127282|NCT01389531|"~     The aim of the study is, primarily, evaluate the safety of the use of the silicone stent~     HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis.~     Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent~     HCPA-1 who are in the same conditions described above and also estimate the costs the use of~     these silicone stents involve.~   "
127283|NCT01389518|"~     The aim of this study is to evaluate the efficacy and safety of a fixed combination of~     paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and~     flu-like illness in adults in a randomized, double-blind, controlled trial. The~     investigators included 146 healthy study subjects aged between 18 and 60 years who presented~     flu or common cold moderate to severe onset of less than 3 days (72 hours). After clinical~     and laboratory evaluation were randomized to receive active drug or placebo, five capsules a~     day, every 4 hours for 48-72h.The outcomes to assess the effectiveness involve the~     measurement of symptom scores, overall duration of symptoms, return to usual activities, use~     of rescue medication, improvement of the fever.~   "
127284|NCT01389505|"~     This is a prospective, randomized and comparative study is to quantify the functional and~     structural alterations of the macula in patients with proliferative Diabetic Retinopathy~     submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab~     as a adjuvant therapy in preventing the adverse events of that procedure. The patients with~     proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation~     will be examined by ophthalmologists who will measure the visual acuity and contrast~     sensitivity, perform slit lamp examination, fundus examination and optic coherence~     tomography before and after laser photocoagulation. Laser photocoagulation will be performed~     in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the~     realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study~     analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and~     one, three and six months after the randomization visit. The fellow eye will be submitted~     only to laser photocoagulation and will be considered as control. It is estimated a sample~     of 30 patients. All procedures, purposes and methods will be explained to all patients.~   "
127285|NCT01389492|"~     The postprandial increase in MDA level following meat meal could cause modification to LDL~     particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat~     will result in a significant decrease in LDL modification.~   "
127286|NCT01389479|"~     The purpose of the study is to evaluate the safety, tolerance and immunogenicity of~     Fluviral™ in healthy adults aged 18-64 years.~   "
127287|NCT01389466|"~     This study was designed in two steps with Step 1, a single-center, double-blind, randomized~     clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal~     study. The investigator evaluate the immunogenicity and safety of the investigational~     vaccine in the subjects during their participation in the study.~   "
127288|NCT01389453|"~     All experimental group patients of 100 patients accept a treatment course stem cell~     transplantation, including one time stem cell transplantation through intravenous injection~     way at the 10-21th day of cerebral hemorrhage, and the 7—14th day of cerebral infarction~     incidence; the second time transplantation through lumbar puncture way at the 7th day after~     the First time transplantation. The control group gives injection through intravenous and~     lumbar puncture ways separately in the corresponding time, but the transplantation matter is~     physiological saline not the stem cell.~   "
127289|NCT01389440|"~     This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of~     Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by~     gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy /~     day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to~     assess the percentage of R0 resections. They have planned a total of 21 visits.~   "
127290|NCT01389427|"~     This is a multicenter, open label, three arms, Phase IB study.~      A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day~     2, day 8 and day 15 in combination with three chemotherapies regimens for patients in~     relapsed/refractory Mantle Cell Lymphoma (MCL):~        -  Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered~          every 3 weeks for 6 cycles,~        -  Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,~        -  Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6~          cycles.~   "
127291|NCT01389414|"~     This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of~     panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX).~     Eligible subjects will be enrolled and randomized to receive first-line combination therapy~     consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame~     of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX)~     combination compared to GEMOX alone in patients with previously untreated surgically~     unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the~     safety profile of the P-GEMOX combination; to assess the objective response rate; to assess~     overall survival; to study the correlation between biomarkers with activity and efficacy.~   "
127292|NCT01389401|"~     -  Saliva plays a key role in the homeostasis of the digestive tract~        -  The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal~          and pharyngeal mucosas~        -  There seems to be no correlation between the severity of reflux episodes and the~          intensity of inflammatory changes, suggesting individual protective mechanisms to~          refluxate exposure~        -  Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux~          Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis~          (Laryngopharyngeal Reflux- LPR)~        -  Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in~          patients with GERD and LPR, but it is unclear if these are primary or secondary to the~          disease.~        -  Hypothesis: The decreased salivary EGF concentrations in patients with reflux~          laryngitis is primary and therefore would not change after treatment and control of the~          disease~   "
127293|NCT01389388|"~     Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk~     of developing cardiovascular disease. The reason(s) for this have not been well~     investigated, but there is a general understanding that systemic inflammation plays a part~     in the increased cardiovascular morbidity and mortality. In spite of the increased risk in~     these patients, they have not been included as a high risk patient group in cardiovascular~     prevention guidelines.~      The investigators have carried out a cardiovascular study of RA and AS patients, as well as~     patients with arthritis for the first time. The investigators have demonstrated cholesterol~     plaques in the carotid artery in some of these patients. Plaques in the carotid artery~     represent a risk for development of cerebral stroke and are significantly associated with~     myocardial infarction. These plaques, which are asymptomatic and do not cause~     haemodynamically significant narrowing, diameter reduction (i.e. operation is not~     indicated), are vascular atheromatous disease. Therefore, according to prevailing~     cardiovascular guidelines (SCORE 2007), these patients shall have secondary prevention with~     a lipid lowering agent with the LDL-cholesterol goal of 1.8 mmol/L and HDL-cholesterol > 1.0~     mmol/L for men and > 1.1 mmol/L for women.~      Statins are cholesterol-lowering drugs, and have been shown to reduce the risk of~     cardiovascular disease significantly. In addition, reduction in the size of coronary plaques~     has been induced by statins, when the LDL has been reduced to 1.6-1.8 mmol/l. Plaques in the~     carotid or coronary arteries have not previously been treated and characterized in patients~     with RA, AS and other inflammatory forms of arthritis.~      The aim of this study is to treat patients with cholesterol plaques in the carotid artery~     with cholesterol-lowering medication, in the form of Rosuvastatin for 18 months, and~     characterize the effects on the plaques in the carotid and coronary arteries. In addition,~     the investigators want to clarify the connection between plaques in the carotid and coronary~     arteries in patients with RA, AS and other inflammatory forms of arthritis.~   "
127294|NCT01389375|"~     Are novel vascular closure devices noninferior to manual compression regarding access site~     complications after coronary angiography?~   "
127454|NCT01387282|"~     The administration of Anamorelin in patients with Stage III-IV non-small cell lung~     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and~     muscle strength.~   "
127295|NCT01389362|"~     There is now a global epidemic of diabetes and obesity affecting more than 300 million~     people worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of~     the population. Patients with diabetes have a 12—25% lifetime risk of developing a foot~     ulcer.The abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension,~     pro-thrombotic state and chronic inflammation in diabetes causes atherosclerosis.A~     significant proportion of subjects have underlying peripheral arterial disease and~     neuropathy. These subjects are at great risk of developing infective foot ulceration~     secondary to impaired vascular supply, sensory loss and minor trauma.Without prompt and~     proper medical treatment, these infective ulcers will deteriorate leading to gangrene and~     limb amputation. In-vitro and in-vivo studies revealed that 5 out of the 12 herbs were~     effective in promoting fibroblast proliferation and angiogenesis. To minimize potential drug~     interactions and adverse effects from multiple components in a recipe of Traditional Chinese~     Medicine (TCM), the investigators have developed a simplified formula from the 12 herbs~     consisting of only two herbs. In this proof-of-concept study, the investigators hypothesize~     that the novel recipe of herbal medicine will expedite healing of early foot ulcer by~     promoting vascularisation and granulation as well as modulating inflammatory response.~   "
127296|NCT01389349|"~     Pain after tonsillectomy can be severe and last ten days.~      Various new surgical instruments have been developed over the years in an attempt to reduce~     postoperative pain with mixed results and increased costs; no single tonsillectomy technique~     is superior to the rest. Patients are discharged to home usually on the day of surgery and~     often suffer significant pain and nausea. Pain medication is often prescribed which can~     cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids~     and may require intravenous hydration at an emergency department.~      Battlefield acupuncture  has been recently developed by the US Air Force and is now being~     used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma.~     This protocol consists of five acupuncture points on the outer ear.~      A recent study has demonstrated decreased pain and agitation in children undergoing ear tube~     insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are~     able to attend school the next day.~      The investigators have been encouraged by the benefits of acupuncture during surgery for ear~     tube patients and also wounded warriors recovering from their injuries. These findings~     motivated us to see if acupuncture during tonsillectomy surgery would result in less pain~     and nausea.~   "
127297|NCT01389336|"~     The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic~     diagnosis and treatment compared to conventional standard care alone in stationary patients~     with Fibromyalgia Syndrome.~   "
127298|NCT01389323|"~     The purpose of this study is to compare the rates of sustained virologic response in each~     cohort (Black-African Americans, Latinos) in this study to historical rate.~   "
127299|NCT01389310|"~     The purpose of this study is to monitor adverse events in HIV-infected children <18 years~     old who are exposed to Atazanavir in a real-world setting in Europe.~   "
127300|NCT01389297|"~     The objective of this research project is to develop, evaluate, and disseminate an~     Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be~     based on the four point cognitive-behavioral program for SMART Recovery~     (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and~     behavioral skills to abstain from drinking, drug use, and problem gambling.~      The investigators will evaluate the effectiveness of the OA web application for heavy~     drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.~      The study design has three conditions: 1) participation in face-to-face SMART Recovery~     meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3)~     combining the OA web application with participation in face-to-face SMART Recovery meetings.~      Study Hypotheses:~        1. All three groups will reduce their alcohol consumption, drug use (if any), and~          alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month~          post-baseline assessments.~        2. The OA only group (Experimental group 1) will show a greater reductions in drinking,~          drug use (if any), and alcohol/drug-related problems relative to the face-to-face only~          (Control) group.~        3. The OA + face-to-face group (Experimental group 2) will have better outcomes on~          drinking and drug use variables compared to the Control group.~   "
127301|NCT01389284|"~     The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg~     tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with~     postsurgical dental pain.~   "
127302|NCT01389271|"~     This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in~     the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with~     primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial~     hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional~     class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety~     and tolerability of the drug and the survival of the patients will be observed.~   "
127303|NCT01389258|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm~     diameter implant in a Chinese population by evaluation of marginal bone level alteration,~     implant stability and implant survival in the posterior maxilla up to 3 years after loading.~     Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.~   "
127304|NCT01389245|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX implants~     in a Chinese population by evaluation of marginal bone level alteration, implant stability~     and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early~     loading of the posterior maxilla is a safe and predictable procedure.~   "
127305|NCT01389232|"~     This is a post-market study of the use of SeriScaffold® for soft tissue support and repair~     in breast reconstruction surgery.~   "
127306|NCT01389219|"~     Introduction of a community-based intervention package including prevention strategies,~     early recognition and management of common postpartum & neonatal problems, as well as prompt~     referral of high risk/complicated cases through trained first level primary health care~     workers, will result in a significant reduction in Postpartum maternal and neonatal~     mortality in Pakistan~   "
127455|NCT01387269|"~     The administration of Anamorelin in patients with Stage III-IV non-small cell lung~     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and~     muscle strength.~   "
127308|NCT01389193|"~     This will be a double-blind, randomised, placebo-controlled, two period cross over study of~     ibudilast in the treatment of chronic migraine.~      For participants resident in Adelaide, South Australia (i.e. local participants):~      The study will involve a screening visit followed by eight visits to the Pain and~     Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH), for baseline~     testing, initiation of the study medications and ongoing data collection (one baseline and~     three study visits during each treatment period).~      At the baseline visit, blood samples to assess biomarkers (glutamate, calcitonin~     gene-related peptide, glial fibrillary acidic protein and S100β) will be taken. Patients~     will then be randomised (in a 1:1 ratio) to commence either ibudilast or placebo treatment,~     which will continue for 8 weeks. Subsequently participants will undergo a 4-week washout~     period. At the end of the washout period a second 8-week treatment block with the~     alternative treatment will commence.~      Patients will complete a headache diary daily for at least 4 weeks prior to the baseline~     visit, throughout the treatment and washout periods and for 4 weeks after treatment ceases.~     The diary will record headache frequency, duration, intensity, pain characteristics and~     medication intake for comparison with baseline data.~      From screening until the final study visit (over a minimum of 6 months) a total of~     approximately 200 mL in blood samples will be taken from each local participant.~      For participants located in country or interstate locations:~      The same study will be undertaken, but instead of attending the Pain and Anaesthesia~     Research Clinic (PARC), within the Royal Adelaide Hospital (RAH) for screening and study~     visits, these will be managed remotely through:~      basic input from the participant's GP during the screening period correspondence with the PI~     and study staff via registered post, phone or Skype scheduled visits to the nearest~     pathology collection centre for blood biochemistry and haematology analysis~      Interstate or country participants will also be exempt from collection of blood samples for~     biomarker analysis, hence a total of approximately 120 mL of blood samples will be taken~     from each interstate or country participant.~   "
127309|NCT01389180|"~     This study will provide critical data regarding the efficacy for reducing drug-and~     sex-related HIV transmission risk behaviors, as well as improving methadone maintenance~     treatment (MMT) outcomes and patient functioning of two transportable counseling models,~     behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as~     compared with the current standard of care model in MMT in China. Evidence-based counseling~     that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT~     will greatly improve the public health benefits of disseminating MMT in China and elsewhere~     in the world.~   "
127310|NCT01389167|"~     The long-term goals of this study are to foster development and dissemination of~     evidence-based behavioral and pharmacological treatments to reduce HIV transmission,~     injection drug use (IDU), and heroin use in Russia. This study will examine the effects of~     combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate~     dependence and reduction of HIV risks in opiate dependent individuals. Specifically the~     study will determine whether extended-release injection naltrexone has greater efficacy and~     is more cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV~     risk reduction counseling (BDRC) combined with brief, medical management (MM) has greater~     efficacy and is more cost-effective than MM only, and whether particular combinations of~     medication formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are~     more cost-effective than other combinations.~   "
127311|NCT01389154|"~     The objective of the prospective, multi-center study is to evaluate the ease of use and~     effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a~     method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and~     beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield~     of similar published historical controls using conventional bronchoscopy.~   "
127312|NCT01389141|"~     The investigators hypothesize that age-related changes in the number and growth dynamics of~     ovarian follicles will be associated with changes in hormone levels and corresponding~     changes in musculoskeletal health.~   "
127313|NCT01389128|"~     The proposed project will be conducted to evaluate the influence of application resources~     associated with non-pharmacological during labor for pain relief and accelerated phase of~     expansion. Although mothers' access to resources for non-pharmacological pain relief during~     labor is recommended, is not seen as the application of routine obstetric practice, although~     it has been demonstrated benefits and scientific evidence with your application. It is~     believed that the implementation of this protocol based on the application of~     non-pharmacological resources in assisting the labor can be introduced into daily practice~     in various hospitals in the country, minimizing pain and favoring the shorter duration of~     labor, decrease in use of painkillers and inductors, resulting in a reduction of~     complications, improves the comfort of the mother making her birth experience more~     satisfying and rewarding, being assisted with security and trained by multidisciplinary~     teams.~   "
127314|NCT01389115|"~     The purpose of this study is to determine lipid metabolism in chronic liver disease in the~     attempt to find a useful biomarker of liver function and of prognostic value of graft~     function in those patients who undergo liver transplant. The present study enrolls subjects~     with liver cirrhosis (with different ethiology), including subjects eligible for a full-size~     liver transplantation, and healthy controls.~   "
127315|NCT01389102|"~     Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in~     postmenopausal women. This study will evaluate the safety and efficacy of Evamist.~   "
127316|NCT01389089|"~     Edema control after ankle- and hindfoot fractures is important. Multi-layer compression~     bandages or A-V Impulse compression may are more effective in reducing edema than ice.~   "
127317|NCT01389076|"~     Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet~     had previous systemic treatment, such as chemotherapy or immunotherapy will be invited to~     participate. This research study is being conducted in order to evaluate the combination of~     lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the~     combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response.~     HAMA is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can~     range from a mild form, like a rash, to a more extreme and possibly life-threatening level.~     HAMA can also decrease the effectiveness of the treatment, or create a future reaction if a~     patient is given another treatment containing mouse antibodies. In addition to evaluating~     the occurrence of HAMA, this research study will also look at the short and long-term~     effectiveness of this combination in the treatment of lymphoma, as well as its safety.~   "
127326|NCT01388959|"~     This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of~     MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal~     residual disease after autologous haematopoietic stem cell transplantation (bone marrow or~     peripheral blood). Two groups of patients will be considered for treatment. Group A:~     Patients with evaluable minimal tumor mass, Group B: Patients with complete response and~     abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2~     intravenously once every week. The anticipated time on study treatment is 4 weeks.~   "
127318|NCT01389063|"~     HIV infected patients treated with abacavir might have a higher risk for the occurrence of~     cardiovascular events. At time of writing of this protocol the underlying mechanism is not~     yet elucidated, however some studies find impaired endothelial function and elevated markers~     of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation.~     Recently maraviroc (Celsentri®), a CCR5-receptor antagonist, became available for treatment~     of patients infected with HIV-1.~      Improvement of endothelial function may be a potential beneficial side effect of treatment~     with maraviroc, due to the potential reduction of immune activation and chronic inflammation~     as a result of blocking the CCR5-coreceptor. Moreover, treatment intensification of HAART~     with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below~     the cut-off of 50 copies/ml as well.~      The investigators hypothesize that maraviroc intensification therapy in patients on an~     abacavir-containing regimen will improve endothelial function.~      The objectives of this study are: First, to assess the effect of addition of maraviroc to an~     abacavir-containing regimen on endothelial function; second, to assess the effect of this~     intervention on markers of immune activation and chronic inflammation, and on plasma HIV-RNA~     below 50 copies/ml.~   "
127319|NCT01389050|"~     This research study aims at defining 1) how retroperitoneal sarcomas change over the course~     of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators~     know that radiotherapy before surgery is safe and effective, the amount of tumor motion and~     size change during radiotherapy is unknown. There is also very little information that~     describes the side-effects of radiotherapy in the treatment of this disease.~   "
127320|NCT01389037|"~     This clinical trial focuses on helping African Americans with high blood pressure to manage~     their disease. The study will target their ability to read and understand health information~     (also called health literacy). The research method relies on community participation in~     equal partnership with the researchers to provide interactive workshops and home blood~     pressure self-monitoring with the assistance of telephone counseling by community health~     workers.~   "
127321|NCT01389024|"~     This is a pilot study of hydroxyurea versus placebo to reduce central nervous system~     complications (abnormally fast blood flow to the brain, silent cerebral infarct or stroke)~     in young children with sickle cell disease. The investigators plan to identify children 12~     to 48 months old without central nervous system complications and randomly assign 20 to~     treatment with hydroxyurea and 20 to treatment with placebo for 36 months. Neither the study~     doctors nor the participants will know which treatment they are receiving.~   "
127322|NCT01389011|"~     The purpose of this study is to:~        1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth~          variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after~          induction of general anesthesia.~        2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and~          non-anesthetized limb.~   "
127323|NCT01388998|"~     Fluid therapy optimization in the perioperative period has been considered as major~     contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid~     requirements in the anesthetized patient with arterial line is the assessment of difference~     in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid~     management approach to avoid both hypervolemia and hypovolemia. However, several clinical~     factors may impede dPP measurements. Surgical manipulations in abdominal procedures may~     interfere with hemodynamic stability due to obstruction of the caval vein. Physiological~     considerations make us hypothesize that only intense pressure impedes caval blood flow and~     thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after~     standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval~     vein.~   "
127324|NCT01388985|"~     Rabies is a viral zoonosis that causes an encephalitis, almost invariably fatal. It is~     widely distributed across the globe: the World Health Organization (WHO) estimates that~     about 2,4 billion people live in endemic areas for canine rabies. Vaccination of domestic~     animals is limited to industrialized and middle-income countries.~      The development of clinical rabies can be prevented through timely immunization after~     exposure: however, preventive vaccination simplifies the post-exposure procedure~     considerably, as immunoglobulins are no longer needed and less vaccine administrations are~     scheduled. Pre-exposure prophylaxis consists of an intramuscular (IM)of intradermal (ID)~     dose given on days 0, 7 and 21 or 28. The development of immunological memory after this~     vaccination is critical for the establishment of long lasting immunity. Subjects receiving a~     booster dose 1 year after pre-exposure prophylaxis segregate themselves into 'good' and~     'poor' responders; the former may not need further boosters for 10 years, whereas the latter~     may need more frequent boosters.~      Until recently, guidelines in travel medicine recommended pre-exposure vaccination only for~     some risk groups. Since recent studies have shown the effectiveness of the ID vaccination,~     the policies are changing towards pre-exposure vaccination for a larger population,~     including travelers to endemic regions, where immunoglobulins and vaccine are often not~     readily available.~      Based on the above, the investigators must stress the concept of boostability after a risk~     exposure. However, the current pre-exposure vaccination scheme could be improved: a schedule~     of 1 week would be less time consuming, would improve compliance and give less interference~     with other prophylaxis measures, e.g. mefloquine. Two small studies suggest that a schedule~     of 1 week interval is as effective and immunogenic as the standard one.~      The investigators will investigate whether the accelerated schedule is as effective as the~     classical schedule, by carrying out a randomized, non-inferiority study.~   "
127325|NCT01388972|"~     Several environmental factors have contributed to the growing pandemic of obesity. It has~     been described that some characteristics of food and built environment have an influence on~     patterns of food consumption and physical activity of people in a certain place.~      We have designed a cross-sectional study to describe some aspects of the food environment~     (community and consumer) and the frequency, distribution and characteristics of the space~     available to perform physical activity in three neighborhoods of Buenos Aires city.~      Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic~     strata, will be selected by convenience to conduct this study.~      The study will consist on three stages: first, the generation of the sampling frame of food~     stores, public and private spaces available for carrying out physical activity, and the~     development of a tool designed to evaluate the availability of healthy foods in supermarkets~     and grocery stores. Finally, a sample of those stores will be randomly selected for~     assessing the availability of selected foods.~      In Argentina, the knowledge of the food environment is limited. We believe that the~     information obtained in this study will contribute to a better understanding of the subject.~   "
127327|NCT01388946|"~     The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients~     undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or~     the analgesic consumption during the first 24 hours.~   "
127328|NCT01388933|"~     The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the~     treatment of Crohn's disease.~   "
127329|NCT01388920|"~     A significant proportion of COPD subjects experience muscle wasting, which has been~     associated with increased morbidity, impaired physical functioning, and a poor quality of~     life.~      Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular,~     weakness of peripheral muscles has been reported to play an important role in the reduced~     functional capacity and impaired exercise performance.~      The primary objective of this study is to investigate the effect of tesamorelin, in~     conjunction with exercise training, on lean body mass measured by dual energy x-ray~     absorptiometry (DXA) scan.~   "
127330|NCT01388907|"~     The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in~     the prevention of adhesions in gynaecologic surgery, and to assess post-operative~     complications related to adhesions and pregnancy rate after myomectomy by open surgery.~   "
127331|NCT01388894|"~     Patients who report that exposure to bright light or strenuous physical activity will induce~     migraine aura will be provoked using one or both of these methods. Followingly the patients~     will be examined by functional MRI. Íf the patients develop migraine headache, MR~     angiography will be performed as well. The primary study hypothesis is that the functional~     MRI signal will show features similar to those of the electrophysiological phenomenon of~     cortical spreading depression.~   "
127332|NCT01388881|"~     The main objective of this study is to evaluate the effectiveness of music education over a~     period of five months (three times per week, one hour per day) on the improvement of reading~     skills (decoding, prosody and phonological awareness) in children (8-10 years) with reading~     difficulties from poor neighborhoods in the city of Sao Paulo. A second objective is to~     develop a theoretical model that may explain how acquired musical skills are correlated with~     the supposed changes in each of the covariates and outcomes in this study.~      The study will be administered to 270 children with reading difficulties from 10 different~     schools (27 children per school). 135 children will have music lessons and 135 will not;~     therefore, 5 schools will be the control and 5 schools will be the intervention group. The~     analysis will consider the cluster structure, since the randomization was not conducted at~     the individual level (i.e., the school level was the randomization unit). For the~     inferential analysis, generalized estimation models and structural equation modeling will be~     used.~   "
127333|NCT01388868|"~     The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery~     is essential for intraoperative motor-evoked potential monitoring. However, the precise~     strategy of administering neuromuscular blocking agent for obtaining that goal has not been~     established. Therefore, the investigators tried to find the optimal initial dose of~     vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by~     neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).~   "
127334|NCT01388855|"~     The purpose of this study is to determine if the methods are feasible for a larger clinical~     trial.The study will examine the relationship between vitamin D status, quality of life,~     pain and walking distance of individuals living with heart failure.~   "
127335|NCT01388842|"~     The purpose of this study is to assess if adding inhaled Nitric Oxide to other malaria~     treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.~   "
127336|NCT01388829|"~     This study is designed to compare the pharmacokinetics of two different lots of tablets.~   "
127337|NCT01388816|"~     The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in~     elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein~     cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for~     heart disease.~   "
127338|NCT01388803|"~     A retrospective study to demonstrate the optimal depth of right side bronchial blocker for~     complete right lung separation. Data were collected from all patients who completed right~     side VATS with right side BB from Jan 2010 through Nov 2010.~   "
127339|NCT01388790|"~     This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants~     with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal~     junction (GEJ) who have not previously received systemic chemotherapy for this setting.~      All eligible participants will receive the combination of cetuximab plus S-1 (a combination~     of tegafur, gimeracil, and oteracil) and cisplatin.~   "
127340|NCT01388777|"~     Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and~     destroy cancer tissue.~      The goal of this clinical research study is to learn about the level of effectiveness of~     using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of~     this procedure will also be studied.~   "
127341|NCT01388764|"~     The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on~     muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine~     reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine~     administration.~   "
127342|NCT01388751|"~     Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a~     mallet injury have the same extensor lag 4 months after initiating treatment as patients~     that do not perform night splinting?~      Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on~     a 5-Point Likert scale)?~   "
127343|NCT01388738|"~     Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's~     very important to choose the right way of the management of the patient and an appropriate~     drugs.~      There is a large number of the so-called neuroprotective drugs, which were effective in~     laboratory, but didn't show positive results in clinical studies with using traditional~     clinical scales scores as a primary outcome measures.~      Specialists suggest, that the investigators could receive better results if the~     investigators change design of the studies, particularly if the investigators select more~     precise and sensitive method of assessment.~      Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation~     of the changes in the motor centers and motor tracts after administration of different~     cerebroprotective drugs. (The substances won't be compared to each other).~   "
127344|NCT01388725|"~     The purpose of this study is to describe the value of serum sTREM (soluble triggering~     receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein~     (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their~     clinical informative value in predicting outcome.~   "
127345|NCT01388712|"~     The most common cause of children chronic constipation is functional disorders. Functional~     constipation is diagnosed after excluding organic causes of constipation (anatomical,~     neurological, endocrinological) and identification of two symptoms defined by the Rome III~     criteria. There could be low number of bowel movements (below three times a week),~     defecation pain, fecal incontinence (once a week), stool consistency or occurrence of large~     diameter stools. The treatment is change of diet, defecation training and application of~     laxatives.~      The probiotics are defined as living microorganisms, which provided in a proper doses should~     result in beneficial effect on a host health. The assessment of its characteristic is~     related to strain of bacteria affiliation.~      Taking into the consideration that patients with constipation may experience microflora~     intestine disorders, using the probiotics can have the positive impact on process of~     treating this disease. The additional reason for using the probiotics during the~     constipation treatment is an influence of probiotics on movement of the alimentary canal.~      In spite of proved effectiveness of some probiotics' strains further research are required,~     because clinical significance is ambiguous and the effect is confirmed among patients with~     short medical history. That's way the further analysis of probiotic Lactobacillus reuteri~     DSM 17938, which was successful treatment method of chronic constipation amongst children~     (infants) should be performed.~      The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy,~     provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The~     baseline of estimation is the frequency comparison of bowel movement in children belonging~     into two groups: Lactobacillus reuteri treatment and placebo.~      The secondary aim of the study is the assessment of frequency the additional symptoms~     connected with defecation disorders: such as: number of pain episodes during defecation, the~     intensity of pain, number of hard stools, number of fecal incontinence per week, number of~     macrogol (Forlax) pockets used.~      The investigators believe that constipation treatment (laxatives- macrogol) with~     Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus~     reuteri in 3-7 years old children with medical history of chronic constipation.~   "
127346|NCT01388699|"~     Recently, there is evidence that endothelial activation and dysfunction are associated with~     migraine, especially in female migraineurs with aura. Our objectives were to determine~     whether novel endothelial function markers are altered in female migraineurs with aura~     compared to age-matched controls.~   "
127347|NCT01388686|"~     Structured web-based survey in selected hospitals with intensive care units in Berlin-~     Brandenburg to collect data on the overall number of blood cultures (used) and the~     prevalence of (positive blood cultures in patients with) CVC - associated sepsis.~   "
127348|NCT01388673|"~     The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational~     instrument indicated for endoluminal trans-oral tissue approximation and ligation in the~     gastrointestinal tract. This study explores the specific application of tissue apposition in~     dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass~     (RYGB) pouch.~      The primary objective of this study is to perform an evaluation of the safety of the ACE~     Stapler for the treatment of dilated post-surgical gastric anatomy.~      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE~     Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up~     period.~   "
127349|NCT01388660|"~     This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to~     investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg~     of Aspirin and the simultaneous administration of the separate formulations of the two drugs~     in healthy male volunteers.~   "
127350|NCT01388647|"~     This study will evaluate the safety and efficacy of eribulin in combination with carboplatin~     and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor~     receptor (HER)2 positive and are clinically stage IIA to IIIB.~      The study regimen will be administered every 3 weeks for a total of 6 cycles followed by~     definitive surgery.~   "
127351|NCT01388634|"~     The aim of the present study was to analyse factors associated with prolonged length of~     hospital stay, readmission and death in a nationwide group of patients undergoing elective~     ventral hernia repair in search for areas of interest to improve outcome after ventral~     hernia surgery~   "
127352|NCT01388621|"~     The purpose of this trial is to estimate the therapeutic efficacy of the experimental~     targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin~     and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective~     standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent~     ovarian cancer. It is expected that the progression free survival rate at 12 months is~     improved by the targeted regimen.~   "
127353|NCT01388608|"~     Data on activities of daily living in patients with rheumatoid arthritis are assessed mainly~     be the health assessment questionnaire (HAQ). The HAQ generates data by subjective~     variables. It would be desirable and advantageous to add objective tools reflecting~     patients' activities to the outcome parameters in rheumatoid arthritis. The StepWatch™~     activity monitor (SAM) in an ankle worn step counter and an accurate instrument to measure~     real world ambulatory activity. The investigators purpose was to investigate whether~     activities of daily living measured by SAM increase during a therapy with the TNF-alpha~     inhibitor etanercept in patients with active rheumatoid arthritis (RA).~   "
127354|NCT01388595|"~     Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the~     population worldwide. It has been reported as being one of the 10 most common causes for~     attendance to primary care clinics. It is clinically defined as a symptomatic disorder of~     the nose induced by an IgE mediated inflammation following allergen exposure of the~     membranes lining the nose and is characterized by varying combinations of nasal symptoms~     including sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids~     form the cornerstone of anti-inflammatory therapy in allergic rhinitis and there is~     increasing interest in the role of intranasal beta 2 agonists in the management of allergic~     rhinitis. The question therefore arises as to whether salmeterol exhibits such synergistic~     activity in the nose in terms of potentiating the steroid response of fluticasone.~   "
127355|NCT01388582|"~     The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl~     estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or~     Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant~     growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be~     randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills~     or identical placebo to start on post-partum day number 42 or Implanon implants or a~     LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The~     pairs will then be followed for four weeks. During this follow-up period, breast-milk intake~     will be quantified by administering deuterium oxide to exclusively breast-feeding mothers~     and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise~     known as the dose-to-mother method of Coward.17 Additionally, maternal and infant~     anthropometric measurements will be collected -- both as a value necessary to implement the~     breast-milk quantification method, as well as an outcome for analysis, and a daily diary~     will be kept by the women participating in the study that records infant feeds and diaper~     changes.~   "
127357|NCT01388556|"~     Exercise is often noted as an important component in a comprehensive approach to the~     management of Parkinson disease (PD). Most studies of exercise have examined the effects of~     short-term interventions and have tested participants on their anti-Parkinson medications.~     As such, these studies have not been able to determine whether or not exercise may have a~     disease-modifying effect in people with PD. The investigators recent work has shown the~     potential benefits of dance as a form of exercise for individuals with PD, but, like~     previous work, has only examined short-term interventions. The investigators think that~     dance may be ideally suited for study over a longer period of time because dance~     incorporates many of the features recommended for inclusion in PD-specific exercise programs~     in a format that is known to be engaging and to enhance motivation to participate in~     healthful behaviors. As such, the investigators aim to determine both the short- and~     long-term effectiveness of a community-based dance program for individuals with Parkinson~     disease and to determine how physical function changes over time in individuals with PD who~     do not exercise as compared to those who exercise regularly. The investigators hypothesize~     that:~      A) participation in dance will result in improved physical function, cognitive function,~     mood and quality of life in people with PD within 3 months,~      B) additional improvements will be noted at 6 months as compared to 3 months,~      C) improvements will be maintained at one year with continued, regular participation in a~     dance class,~      D) those who do not exercise will show significant functional decline over a period of one~     year, a decline that will not be present in those who dance regularly.~   "
127358|NCT01388543|"~     This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5~     (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people~     with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to~     people with the normal metabolizing genotype.~   "
127359|NCT01388530|"~     This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and~     feasibility of trigeminal nerve stimulation (TNS) as a treatment for~     Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label,~     exploratory, pilot study will provide a basis for a federal grant application and larger~     controlled trials.~   "
127360|NCT01388517|"~     Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its~     chronic course, trend to relapse and aesthetic impact. Currently, no treatment is widely~     accepted. The objective is to assess the calcitriol and tacrolimus ointment efficacy in the~     treatment of PA compared with petrolatum. Twenty lesions on the face greater than 3 cm, in~     individuals of phototype IV-V, aged 3-18 years are going to be randomly assigned to receive~     petrolatum, calcitriol, and tacrolimus twice daily. No photoprotection is going to be~     indicated, and hygienic habits will not be modified. Patients will be evaluated at baseline~     and for 9 weeks, by means of Transepidermal Water Loss (TEWL), colorimetry, clinically and~     by photography control.~   "
127361|NCT01388504|"~     The research question to be addressed is Does a 2.5 - 5 minute systemic intravenous~     injection of sodium nitrite administered immediately before opening of the infarct related~     artery result in significant reduction of ischaemia reperfusion injury in patients with~     first acute ST elevation myocardial infarction (MI)?~   "
127362|NCT01388491|"~     This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive~     compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy~     women.~   "
127363|NCT01388478|"~     By doing this study, researchers will examine the safety and tolerability of R-pramipexole~     in participants with Alzheimer's disease. This study will also examine the body and brain's~     response to the study drug by measuring the amount of injury to the cells (oxidative stress)~     in the blood and spinal fluid and brain imaging before and after treatment.~   "
127364|NCT01388465|"~     The investigators are testing the hypothesis that patients who are exposed to daily~     text-message (TM) assessments with feedback will have better adherence to prescription than~     those patients not exposed to TM-based queries with feedback.~   "
127365|NCT01388452|"~     Purpose: The purpose of this research study is to learn about two HIV tests - a clinical~     presumptive diagnosis (PD) that a trained healthcare provider can quickly use to determine~     if a child is likely to be HIV-infected and in need of HIV medicines and an expedited gold~     standard RNA-PCR test (expedited PCR) that is done at the UNC Project lab located at the~     hospital and the result given within 48 hours. Both of these tests can obtain results~     quickly while the current test called dried blood spot DNA-PCR goes to a lab and the result~     may take up to one month. The performance of PD and expedited PCR will be compared to one~     another with respect to HIV-infected infants correctly initiating life-saving antiretroviral~     therapy.~      Participants: Hospitalized children younger than 12 months of age who are HIV DNA-PCR~     eligible at Kamuzu Central Hospital (KCH), in Lilongwe, Malawi. Other participants will be~     patient caregivers and clinical officers who provide healthcare for children that could be~     HIV-infected. Clinical officers will be trained to conduct the presumptive diagnosis test.~      Procedures (methods): Patients will be randomized to either standard of care (PD and dried~     blood spot DNA-PCR) or expedited PCR. A consultant pediatrician and a clinical officer will~     perform the PD. If the PD or expedited PCR test results are positive, hospital care could~     include HIV medicine.~   "
127366|NCT01388439|"~     Oseltamivir dosing in infants < 3 months of age is based on a single pharmacokinetic study~     in 20 infants from a single center. This dataset is limited by a lack of robustness, because~     only 1 sample was collected from each participant. The investigators obtained two blood~     samples each from infants receiving oseltamivir after obtaining informed consent from the~     infant's parents. The investigators propose to analyze the blood samples to determine the~     amount of oseltamivir in the infant's blood. Measurement of these values will increase the~     understanding of the absorption and elimination of oseltamivir in preterm and term infants,~     and improve our ability to provide the correct doses to this high risk population.~   "
127397|NCT01388036|"~     Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD~     and hypertension. However, there is large interindividual variability in the response to~     beta blockers.~      The hypothesis underlying this study is that genetic differences between individuals will~     determine the individual response to esmolol, a betablocker that is administered~     intravenously. Esmolol will be administered intravenously to healthy volunteers, and the~     effects on heart rate and blood pressure will be monitored. In addition, we will measure~     plasma renin activity and plasma levels of norepinephrine.~   "
127367|NCT01388426|"~     Objective of this study is to evaluate the tolerance and potential benefit of moisture~     chamber glasses for dry eye in an Asian population. In this clinic based prospective~     interventional study, we aim to recruit patients (until 10 patients complete the study) who~     have evaporative dry eye due to exposure to environmental stress (such as frequency of out~     door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye~     clinic in Singapore National Centre. After informed consent, these patients will be~     prescribed 7eye( Panoptx)™ moisture chamber glasses/eyewear for 3 months and will be~     monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of~     eye drops for each type of medication used. Other outcomes will be changes in symptoms of~     dry eye using visual analog scale, as well as objective signs of dry eye (eg. corneal~     fluorescence staining and tear break up time (TBUT). As moisture chamber spectacles are~     currently not available as a treatment option for dry eye in Singapore, the findings of this~     study will give an insight to the efficacy of this new treatment modality in our population.~   "
127368|NCT01388413|"~     Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the~     main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic~     therapy increases the risk of multi-resistant bacterial infections, without reducing the~     rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral~     Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and~     antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs~     and the number of hospitalizations in patients with neurogenic bladder, without affecting~     bacterial ecology.~      The objective of this study is to validate this preliminary work with a large-scale~     randomized, parallel-group, multicenter study.~   "
127369|NCT01388400|"~     Stroke contributes significantly to the incidence of disabilities, with upper limb (UL)~     motor impairment being especially prevalent. Animal studies suggest that post-stroke motor~     recovery is largely attributable to adaptive plasticity in brain motor areas. While some~     environmental training factors contributing to plastic mechanisms have been identified in~     animals, translation of this knowledge to the clinical setting is insufficient. Optimal~     recovery may be related to both external (e.g., feedback type) and internal factors (e.g.,~     cognitive ability, motivation). Clinically feasible methods for training are needed. Use of~     enriched virtual environments (VEs) may provide a way to address these needs. Outcome~     measures that best reflect recovery need to be identified since this is an essential step to~     evaluate the effect of novel training programs for UL motor recovery in stroke.~      The research question is which clinical and kinematic outcome measures best reflect motor~     performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare~     changes in outcome measures recorded before and after an upper limb intervention in stroke~     subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance~     between-group differences sample size is based on knowledge of expected outcome measure mean~     score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome~     measures will be sensitive to within-group (pre-post intervention training) changes.~     Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to~     between-group (healthy vs. patients in enriched vs. conventional intervention groups.~     Sixteen chronic stroke survivors and 8 age- and sex-matched healthy controls will~     participate. Patients will be matched on cognitive and motor impairment levels and divided~     into two groups. Using an single subject (A-B-A) research design, kinematics during two~     pre-tests, 3 weeks apart, will be recorded for test-retest reliability. Stroke groups will~     practice varied upper limb reaching movements (15 45-minute sessions in 3 weeks) in~     environments providing different motivation/feedback levels. Pre- and post motor performance~     evaluations will be done with clinical tests and a Test Task with specific motor performance~     requirements. A Transfer Task will also be recorded. By comparing data analysis methods~     (3-Dimensional (3D) analysis of different markers or placements), the investigators will~     identify which kinematic outcome measures best reflect motor improvement in post-test and~     follow-up sessions (retention).~      The expected results are identification of two primary and two secondary outcome measures~     that reflect upper limb motor recovery and can distinguish between motor recovery and~     compensation. The results will be used to design a randomized control trial to determine the~     efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic~     (environmental) and intrinsic (personal) motivational factors affect motor learning in~     stroke survivors with cognitive and physical impairment. Knowledge gained can also be used~     for rehabilitation of other neurological and orthopedic pathologies.~   "
127370|NCT01388387|"~     The choice of an immunosuppressant after hepatic transplant is now more difficult than~     before because of the increasing number of drugs available.~      Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best~     treatment and the best dose for each patient. The genetic polymorphism of enzymes~     metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5~     activity is a major determinant of the dose needed to reach target concentrations. This~     study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic~     polymorphisms on tacrolimus exposure in patients with hepatic transplant.~   "
127371|NCT01388374|"~     The aim of this study is to explore whether the implementation of Nurse Practitioners can~     lead to a more accessible and efficient patient care at the primary out of hours service.~      The primary objectives of the proposed study are:~        1. What are the effects of the implementation of NPs on the primary out of hours service~          in comparison with the current out of hours service? Effects in terms of accessibility,~          objective and subjective workload of general practitioners, quality of care and patient~          satisfaction.~        2. How efficient is the implementation of NPs in the primary out of hours services?~        3. What is the feasibility of the implementation of NPs in the out of hours services? And~          under which conditions?~        4. What are the barriers and facilitating factors considering the implementation of NPs?~   "
127372|NCT01388361|"~     This trial is conducted in Europe and North America. The aim of this trial is to compare the~     efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest~     meal to insulin degludec in subjects with type 2 diabetes.~      Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643~     (NCT01193309) trial will be randomised to receive treatment intensification while subjects~     with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to~     receive insulin degludec treatment. Subjects are to continue their pre-trial metformin~     treatment.~   "
127373|NCT01388348|"~     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is~     invasive time consuming and requires expensive and complex set-up. In this study the~     investigators plan to evaluate an alternative technology that presumably is able to diagnose~     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow~     Vibration Analysis technology. The acoustic vibration sensor is a small device that records~     the vibration due to urine flow. The patient attaches the sensor to the penis using a~     disposable sensor patch for the duration of approximately one minute during one urination.~     The analysis is performed off-line and the results are compared to the results of a standard~     pressure flow study. The innovative technology for the diagnosis of bladder outlet~     obstruction is noninvasive, rapid and does not involve complex setup.~   "
127398|NCT01388023|"~     In a previous study the prevention of halitosis by the herbal formula and delivery system~     (SmellX), were established both in vitro and clinicaly. The duration of relief was~     established as long as 8 hours. In this study the investigators intend examine the day long~     efficacy of SmellX.~   "
127374|NCT01388335|"~     The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein~     (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in patients with~     solid tumors or lymphomas. Information about any side effects that may occur will also be~     collected. This is a drug interaction study so the treatment of the disease will not be the~     main purpose of the study.~      This is a Phase 1, open label, fixed sequence, 2 period study conducted in patients with~     solid tumors or lymphomas. The duration of participation in this study will be up to~     approximately 38 days not including screening, after which patients will be allowed to~     continue receiving enzastaurin. There is no planned duration for the extension phase of this~     study; patients will be allowed to continue to receive enzastaurin until fulfilling one of~     the criteria for discontinuation, such as unacceptable toxicity or disease progression.~   "
127375|NCT01388322|"~     This is a Multicenter, randomized, open‐label, parallel groups study to test the hypothesis~     that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks~     of gestation could improve maternal and perinatal outcome in women at high risk for~     developing placental‐mediated pregnancy complications.~   "
127376|NCT01388309|"~     This observational study will evaluate in clinical practice the change in Disease Activity~     Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who~     are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from~     eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without~     methotrexate) for 12 months.~   "
127377|NCT01388296|"~     the target of this study is to assess the minimum alveolar concentration of sevoflurane to~     maintain theBispectral Index below 50.The minimum alveolar concentration (MAC) for~     maintaining Bispectral Index below 50 (MACBIS50) of sevoflurane has been reported previously~     in adult with Body Mass Index ( BMI) < 40 to be 0.97 and in enfant to be 2.83%, However,~     there is no study assessed theBispectral Index below 50 (MACBIS50 ) in morbidly obese~     patient (BMI > 40). The first aim of our study is to assess the MACBIS50 of sevoflurane in~     morbidly obese patients BMI 40 - 70 using the Continuous Reassessment Method (CRM) in 80 %~     of patients.~   "
127378|NCT01388283|"~     The purpose of this study is to assess the predictive role of serum inflammatory markers in~     pregnant women who subsequently develop preeclampsia.~   "
127379|NCT01388270|"~     The purpose of this study is to determine whether the heparin-coated dialysis filter is~     superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis~     (HD) patients.~      The antithrombogenic properties of the heparin-coated dialysis filter and of the~     conventional filter will be compared by means of statistical tests.~   "
127380|NCT01388257|"~     The purpose of this study is to demonstrate, in patients treated with adalimumab, the~     efficacy of proctological surgery in anoperineal fistula healing after the removal of seton~     drain.~   "
127381|NCT01388244|"~     The Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) is a randomised~     population-based study, including 20,904 Danish women aged 65-81 years, investigating the~     effectiveness of a two-step screening programme for osteoporosis, using a questionnaire~     based on FRAX® followed by DXA-scan of those at highest risk. Further, the study is expected~     to provide knowledge about cost-effectiveness, patient preferences and acceptance of~     screening programme to prevent fractures~   "
127382|NCT01388231|"~     The study aims at examining the effects of additional training in manualized~     cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia.~     The investigators will investigate how CBT, specifically the treatment procedures and~     manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into~     the less structured setting of routine clinical care, and whether the health care system~     benefits from such developments. Private practitioners (N=36) will be randomized to one of~     two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without~     specific training). The investigators plan to enroll 160 patients (80 per condition) to be~     able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out~     rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to~     promote faster and more widespread dissemination of effective interventions. The following~     research questions can be examined: (1) Can manualized CBT be successfully implemented into~     routine outpatient care? (2) Will the new methods lead to an improvement of treatment~     courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be~     comparable to those of the controlled, strictly manualized treatment of the main study?~   "
127383|NCT01388218|"~     The purpose of the protocol is to develop final draft PRO instruments of physical activity~     in daily life to be used and evaluated in the further validation studies measuring physical~     activity in chronic obstructive pulmonary disease (COPD) patients.~   "
127384|NCT01388205|"~     This study aims to implement a new family-based health behavior community program to~     increase time spent outdoors and physical activity among Singapore children aged 6 to 12~     years in a 1-year randomized clinical trial. 300 children from 250 families will be randomly~     assigned to either a family-based intervention or no intervention. The family-based~     intervention comprises structured weekend outdoor activities organized by National Parks and~     incentives for children to wear a pedometer and increase their daily steps. Families who~     meet their monthly step and outdoor activity goals will receive a range of prizes and~     incentives. Both groups will receive brochures on the National Myopia Prevention Program and~     physical activity. The success of the intervention will be evaluated through light meters,~     7-day outdoor diaries, questionnaires documenting outdoor time and myopia; as well as~     pedometer steps, walking tests, and body mass index. A community-based intervention will be~     developed to improve the health of Singapore children by increasing outdoor time and~     physical activity to prevent myopia and obesity.~   "
127399|NCT01388010|"~     The purpose of this study is to evaluate the effect of a commercially available fermented~     dairy product containing probiotics (4 weeks, twice a day) on the improvement of~     gastrointestinal well being and digestive symptoms in adult women reporting minor digestive~     troubles among the general population.~   "
127456|NCT01387256|"~     This double blinded, placebo-controlled randomized trial will compare the safety, efficacy~     and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period~     (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of~     mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800~     mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the~     participant.~   "
127385|NCT01388192|"~     Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile~     duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought~     to be moderately severe, and about 20% of these patients go on to develop new clinical~     diabetes. PD-related factors of glucose metabolism will include removal of half of the~     pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight~     loss (on average, ~8% of body weight), and removal of putative diabetogenic factor in~     resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has~     never been studied. The investigators plan to examine this issue by comparing fasting plasma~     levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1~     response after a standard meal, and body mass index (BMI) of patients before and after PD.~   "
127386|NCT01388179|"~     Autism is a developmental disorder characterized by abnormalities in speech and~     communication, impaired social functioning, and repetitive behaviors and interests. The term~     Autism spectrum disorders or ASD is often used to include autistic disorder, Asperger~     syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS).~     Epidemiological research suggests that ASDs affect at least 60 per 10,000 youth, with~     estimates as high as 120 per 10,000.~      Severity of autistic features is not easily defined and the use of different diagnostic~     tools compounds the ability to lay a clear cut definition. It is, though, generally accepted~     that children with autism and normal IQ (>70) are high functioning regardless of the~     severity of their autistic features. The investigators will use the terms autism and ASD~     interchangeably, and the term low functioning autism will be used to describe those~     children with autism who have, or are presumed to have, IQ<70.~      The pathophysiology of autism has been studied extensively in the last decade. Abnormal~     neuronal connectivity has been implicated in a growing body of research. In addition, areas~     of over and/or under neuronal activation have been detected on functional MRI(Magnetic~     Resonance Imaging).~      Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive technique that allows~     to affect brain activity. The pulses are administered by passing high currents through an~     electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric~     field in the underlying brain tissue. When the induced field is above a certain threshold,~     and is directed in an appropriate orientation relative to the brain's neuronal pathways,~     localized axonal depolarizations are produced, thus activating the neurons in the relevant~     brain structure.~      rTMS has been studied in individuals with high functioning autism. rTMS treatment was found~     to have an electrophysiological effect and to reduce repetitive behaviors and improved~     social functioning.~      In the context of existing pilot data suggesting effect of rTMS treatment in individuals~     with high functioning autism, the investigators propose a pilot study to assess the efficacy~     of rTMS in children and adolescents with low functioning autism.~   "
127387|NCT01388166|"~     The objective of this observational study is to collect and evaluate data on medication~     adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g.~     Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.~   "
127388|NCT01388153|"~     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken~     without or with water and the Glucobay standard tablet taken with water~   "
127389|NCT01388140|"~     The goal of the project is to investigate the prevalence of dissociative disorders in~     psychiatric inpatients in Taiwan. Relevant clinical issues, including common psychiatric~     comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g.,~     negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g.,~     executive functions) were also targeted. Standardized interview schedules, self-report~     scales, and cognitive tasks will be applied. The investigators hypothesized that~     dissociative disorders would be associated with positive psychotic symptoms, a history of~     early interpersonal adversity, and enhanced executive functions.~   "
127390|NCT01388127|"~     The investigators will perform a double blind controlled study to investigate the efficacy~     of oral administration of 200 mg minocycline, on the neurological and functional outcome~     after acute hemorrhagic stroke and the effect on blood brain barrier permeability.~   "
127391|NCT01388114|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for serum PCT level measurement will offer a test with lower cost, and increase the~     applicability of serum Procalcitonin (PCT) level in daily clinical practice.~   "
127392|NCT01388101|"~     To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection~     in clinical specimens of Hepatocellular carcinoma (HCC) patients, the investigators conduct~     a prospective clinical study. In comparison with results from direct sequencing of LECT2,~     the investigators evaluate the performance of e- Ab sensor, including reproducibility,~     sensitivity, specificity, and cross-reaction. With such technique, the investigators can~     obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer~     more individualized treatment for our patients.~   "
127393|NCT01388088|"~     The investigators wish to investigate the potential effects of potassium. In this study we~     will examine patients with hypertension and increase their potassium-levels using Amiloride~     and Spironolactone.~      The investigators will examine the changes in the cardiovascular system using a~     Sphygmocor-scanner.~   "
127394|NCT01388075|"~     The genetic factors associated with variability in CYP2C9 induction have not been~     elucidated. The hypothesis underlying this study is that following 7 days treatment with~     rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements~     controlling CYP2C9 expression will be associated with the magnitude of change in INR~     response to warfarin and in CYP2C9-mediated warfarin metabolism.~   "
127395|NCT01388062|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for influenza virus detection, the investigators conduct a prospective clinical study. In~     comparison with results from direct sequencing of influenza virus, the investigators~     evaluate the performance of e- Ab sensor, including reproducibility, sensitivity,~     specificity, and cross-reaction. The potential factors which may interfere with the results~     would be investigated. With such technique, the investigators hope to make early diagnosis~     and give influenza virus patients early treatment to reduce the complications and~     case-fatality rate.~   "
127396|NCT01388049|"~     To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection,~     the investigators conduct a prospective clinical study. In comparison with results from~     direct sequencing of Entervirus 71, the investigators evaluate the performance of e- Ab~     sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The~     potential factors which may interfere with the results would be investigated. With such~     technique, the investigators hope to make early diagnosis and give EV71 patients early~     treatment to reduce the complications and case-fatality rate.~   "
127457|NCT01387243|"~     To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing~     to lose weight.~   "
127540|NCT01386216|"~     The purpose of this study is to evaluate the safety of administration of marrow-derived~     autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for~     the treatment of Critical Limb Ischemia (CLI).~   "
127400|NCT01387997|"~     To develop a real-time diagnostic technique with e- Ab sensor for high risk human papilloma~     viruses(high risk HPV) detection, the investigators conduct a prospective clinical study. In~     comparison with results from direct sequencing of HPV, the investigators evaluate the~     performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and~     cross-reaction (such as detection of low risk HPV). The potential factors which may~     interfere with the results would be investigated. With such a real-time diagnostic~     technique, the investigators hope to obtain information of patients in cost-saving and~     time-saving way and can give patients early treatment and offer more individualized~     treatment for our patients.~   "
127401|NCT01387984|"~     In this study, the investigators plan to establish the relationship between plasma~     concentration of YKL-40 with various vascular complications in the patients of type 2~     diabetes.~   "
127402|NCT01387971|"~     Currently, due to the advantage of noninvasive, localized, rapid, painless and easily~     repeatable of impression specimens, the technique is an ideal method of investigating ocular~     surface disorders when the diagnosis is not clinically obvious or detecting the~     post-operative change without tissue damage. Using impression cytology for primary diagnosis~     and follow-up of ocular surface squamous neoplasia, including after therapy with topical~     mitomycin C has been well-studied. [29]. In addition to the applications described above,~     pterygium is another disease of interest. Pterygium, a common disease of ocular surface, has~     high recurrence rate after surgical excision. [30-33] However, the exact etiology and~     mechanism for recurrence is unknown. A transformation of the phenotypic characteristics of~     the conjunctival fibroblasts may play an important role. Due to the concern of improvement~     in treatment, it is important to explore the change of cytomorphology after pterygium~     operation, to identify the risk factors of developing recurrence, and, furthermore, to~     clarify the etiology and mechanism. Some ophthalmologists may think this procedure too~     time-consuming to be a routine examination in outpatient clinics. [34] However, National~     Taiwan University Hospital (NTUH), as one of the largest tertiary medical centers in Taiwan,~     is now in charge of a big part of difficult cases of ocular surface. With the need of~     further precise diagnosis and delicate clinical skills, the investigators are competent for~     this meaningful program.~   "
127403|NCT01387958|"~     This is a proof of concept study, designed to look at the safety and antiviral activity of~     LCQ908 in hepatitis C infected patients.~   "
127404|NCT01387945|"~     This intervention study will evaluate the feasibility,acceptability and effectiveness of an~     e-health enabled model of care by randomly assigning a trained patient navigator and/or a~     blood pressure (BP) self-management web portal to patients with uncontrolled hypertension~     after a run in period with a home BP monitor (HBPM) and comparing the results on blood~     pressure control. We anticipate that patients receiving the combination of a patient~     navigator(PN)with a self-management web portal and home BP monitor will have better BP~     control than when the only received a home BP monitor.~   "
127405|NCT01387932|"~     The purpose of this study is to evaluate overall survival in patients treated with~     HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with~     particle PVA.~   "
127406|NCT01387919|"~     Several studies have begun to determine the time course of events sensing energy~     availability in rodents. In contrast, there is not a single study that has examined this in~     humans to date. A better understanding of this energy sensing machinery in humans is of~     utmost importance to give us new insights into developing new therapies for common diseases~     such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases,~     disturbances in the energy-sensing machinery possibly play a role. To determine the time~     course of energy sensing events in humans, the investigators will measure the concentration~     of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time~     points during starvation in humans. The investigators choose to study the molecular~     machinery in muscle, since muscle is very sensitive to fuel deprivation.~   "
127407|NCT01387906|"~     The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost~     .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is~     a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the~     Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will~     be day 270 period.~   "
127408|NCT01387893|"~     The objective of this study was to evaluate the effectiveness of the Digital Repetitive~     Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic~     relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.~   "
127409|NCT01387880|"~     This is an open, multicenter phase II trial of therapy with a combination of cetuximab, and~     irinotecan every second week combined with a daily dose of everolimus to patients with~     metastatic colorectal cancer with Kirsten rat sarcoma viral oncogene (KRAS) mutation or to~     patients resistent to cetuximab and irinotecan therapy for metastatic colorectal cancer.~   "
127410|NCT01387867|"~     According to Danish and international guidelines the recommended first-line of management~     for people with osteoarthritis consist of exercise, education, analgesic medication, and, if~     necessary, weight reduction. It is well documented that exercise has a positive effect on~     pain and physical function in patients with knee OA, but the effect of exercise on hip OA is~     sparsely investigated.~      Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking,~     and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical~     activity, and health related quality of life in patients with osteoarthritis of the hip.~      The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e.,~     disease activity, inflammation, and cartilage degradation, are investigated in a subgroup~     (n=45) of the participants.~      Study hypotheses: Strength training will have a greater effect on physical function and~     muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a~     greater effect on endurance than strength training and unsupervised home based exercise; 3)~     Strength training and Nordic Walking will have a greater effect on pain level and health~     related quality of life than unsupervised home based exercise.~   "
127411|NCT01387854|"~     There is limited information on the long-term effects of treating patients with MPS VI with~     Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients.~     The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term~     Naglazyme treatment and the natural history of the MPS VI patient population.~   "
127412|NCT01387841|"~     -  This randomized controlled three arm study compares the effects of a yoga intervention~          with jacobsons progressive muscle relaxation training and only standard of care in~          chemotherapy naive cancer patients.~        -  This study will also assess the neurophysiological correlates of nausea and vomiting~          and assess if effects of intervention on nausea and vomiting outcomes are mediated by~          changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic~          function and sympathetic skin response) or self reported anxiety.~   "
127413|NCT01387828|"~     The purpose of this study is compare two different surgical treatments of splenic artery~     aneurysms: open and laparoscopic approach.~   "
127414|NCT01387815|"~     The current study will compare the real - life effectiveness of adalimumab to topical and~     traditional systemic agents in the management of psoriasis and its impact on the patient's~     quality of life and societal burden of illness.~   "
127415|NCT01387802|"~     The current study will assess the real - life effectiveness of adalimumab in the management~     of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of~     extra-articular manifestations.~   "
127416|NCT01387789|"~     An observational, non-interventional study on social, economic and quality-of-life outcomes~     of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.~   "
127417|NCT01387776|"~     This is a study for the evaluation of the benefits of 1 st Trimester risk markers in~     detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a~     potential marker for Trisomy 21 and other aneuploidies.~      Aim of this prospective nonprofit study is to analyze the benefits of early onset pre~     eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood~     pressure and Doppler ultrasound), and how the results can permit to modify or influence the~     course of the preeclampsia during the pregnancy. The investigators will also evaluate the~     potential use of the PIGF as a marker to improve the prenatal screening with the currently~     used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta~     subunit of human chorionic gonadotropin (fBhCG) parameters.~   "
127418|NCT01387763|"~     The purpose of the study is to compare the efficacy and toxicity including quality of life~     of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea~     (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant~     interferon.~   "
127419|NCT01387750|"~     A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated~     Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy~     adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met~     eligibility requirements were instructed to identify one area on their body where they were~     experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with~     visual analog scales in order to quantify their pain. Patients either received mentholated~     cream with or without OGT and instructed to rub on the identified site 3 times a day for 7~     days. Pain and other observations were written in a diary for each day.~   "
127420|NCT01387737|"~     The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy~     or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with~     Type 2 diabetes mellitus on 52 weeks oral administration.~   "
127421|NCT01387724|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients~     with newly diagnosed neuroblastoma.~   "
127422|NCT01387711|"~     This trial will be conducted to explore the biological effects in the skin following~     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by~     histology.~   "
127423|NCT01387698|"~     The primary objective of this study is to confirm the long-term efficacy (remission and~     maintenance in remission) of current validated treatments. Each patient will be followed~     during 3 years in this non-interventional trial.~   "
127424|NCT01387685|"~     Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The~     investigators will compare data from the chart, telephone interviews and physical~     examinations between those who underwent mesh placement to those who underwent placement of~     PIVS.~   "
127425|NCT01387672|"~     Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of~     nitroglycerin (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of~     isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch),~     for their efficacy on markers of bone formation and resorption and for the incidence and~     severity of headache they cause.~      Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in~     bone remodeling against the common side effect of headache.~      NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and~     resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with~     alendronate, risedronate or zoledronate.~   "
127426|NCT01387659|"~     This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in~     diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant~     recipient population, our study will determine any different responses, including~     autoimmunity, between Hispanic, and Caucasian, patients.~   "
127438|NCT01387503|"~     This clinical trial is aimed at extending the chance of liver transplantation, through~     downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding~     conventional Milan Criteria.~      Those patients that will achieve a sustained tumor response after downstaging will be~     randomized either to undergo liver transplantation or to proceed with conventional~     non-transplant treatments.~      The aim of the study is to demonstrate unequivocally that liver transplantation may provide~     a survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients~     that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy~     is that response is chosen rather than stage migration as endpoint of downstaging.~   "
127458|NCT01387230|"~     The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation~     Powder is safe and effective compared with placebo or no active drug intake, when~     administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).~   "
127427|NCT01387646|"~     The purpose of this Stage II clinical trial is to test the efficacy of a culturally~     sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority~     adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy~     and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging~     contraceptive use. Its primary goal is to expand risk-reduction interventions created in~     previous studies to further increase intervention efficacy for this particularly vulnerable,~     high-risk group. An adolescent intervention has been created and pilot tested in~     developmental studies. Results indicated reductions in substance use, risk behaviors,~     unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of~     the current study include: 1) To obtain a more in-depth understanding of configurations of~     psychosocial and situational factors associated with high-risk sexual behavior, substance~     use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To~     implement a controlled randomized trial of a cognitive behavioral risk-reduction~     intervention consisting of 2 small group sessions, 2 individual counseling and 3 support~     groups for this group; 3) To evaluate the effects of the adolescent intervention model~     versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related~     constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use,~     unintended pregnancy and STI/HIV at 6 and 12 months follow-up. Participants will include a~     convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years~     with a history of sexual or physical abuse and current STI.~   "
127428|NCT01387633|"~     The purpose of this study is to evaluate the impact of an educational program for people~     with diabetes mellitus based on the family social support.~   "
127429|NCT01387620|"~     This prospective study was performed to compare two ophthalmic viscosurgical devices,~     DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose~     2% in terms of their overall clinical performance during phacoemulsification.~   "
127430|NCT01387607|"~     The purpose of this study is to evaluate the efficacy and tolerability of pregabalin~     compared with placebo for management of fibromyalgia in adults.~   "
127431|NCT01387594|"~     Study is designed to show a lack of effect on white blood cells circulating in the spinal~     fluid.~   "
127432|NCT01387581|"~     The objective of this study is to determine and compare the performance of dermatologists~     (in Germany) on the excision decision against the performance of MelaFind, a non-invasive~     and objective multi-spectral computer vision system designed as a tool to aid dermatologists~     in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is~     superior to the average excisions sensitivity of dermatologists.~      Another objective is to determine and compare the performance of dermatologists (in Germany)~     with and without the aid of MelaFind. The hypothesis is that the average excision~     sensitivity of dermatologists with the aid of MelaFind is superior to the average excision~     sensitivity of dermatologists without the aid of MelaFind.~      A similar study was previously conducted with dermatologists in the US (NCT01011153). An~     exploratory objective is to compare the excision decisions of dermatologists from the~     previous study (in the US) to dermatologists in in this study (in Germany).~   "
127433|NCT01387568|"~     In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine~     in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and~     hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten~     return of bowel function.~   "
127434|NCT01387555|"~     This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more~     effective in improving survival than best supportive care in patients with advanced~     Hepatocellular Carcinoma (HCC) who have failed sorafenib.~   "
127435|NCT01387542|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of~     emotional instability, detachment from reality, often with delusions and hallucinations, and~     withdrawal into the self) participants.~   "
127436|NCT01387529|"~     The objective of this study is to establish reference values for non-invasive hydration~     status markers. Although there are no hypotheses associated with this study, the outcome~     will help advance the development of non-invasive hydration status monitors (described above~     and in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The~     outcome that this research effort supports what is recognized by the military community as a~     high priority medical technology gap (MOM ICD v1.3, 2008).~   "
127437|NCT01387516|"~     The long-term objective of this research is to increase the investigators understanding of~     effective smoking interventions for understudied adolescents at high risk for continued~     smoking into adulthood.~      This randomized clinical trial uses a 2 x 2 between groups design to investigate~     Motivational Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior~     Therapy (CBT) versus Self-Help Programming (SHP). Treatments are provided during brief stay~     in detention and adolescents are followed after release. The investigators seek to increase~     quit rates post-release, and the investigators will examine the moderating and mediating~     effects of motivation, anger, and self-efficacy. The investigators will study main effects~     for treatment as well as whether the combination of MI/CBT is more effective than other~     treatments in enhancing quit rates.~      Frequently, treatment for smoking cessation is unavailable to youths in the juvenile justice~     system, and when treatment is available, it may be provided using untested therapies. This~     study extends previous research by rigorously evaluating smoking cessation interventions~     specifically for teens at highest risk for continued smoking in adulthood. The investigators~     will examine processes contributing to the efficacy of treatments. The development of~     effective smoking interventions for juvenile detainees has the potential to reduce a~     significant public health concern in this undeserved and high-risk population.~   "
127449|NCT01387347|"~     Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide~     that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal,~     ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated~     that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye.~     RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be~     a product that meets a major unmet medical need in patients with dry eye.~   "
127439|NCT01387490|"~     This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and~     Usual Care (UC) for service members with Mild Traumatic Brain Injury (mTBI). A total of 400~     service members will participate in this study. ISTS is a telephone intervention that~     provides injury-related education, training in problem solving, and focused behavioral~     strategies for problems (e.g. anxiety, depression) that commonly co-occur with MTBI. ISTS~     also includes access to usual care and web-based and printed educational material. The 12~     phone calls included in ISTS will be administered over a 6-month period. UC is the usual~     care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at~     Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12~     mailings of educational materials over a 6-month period. Subjects will complete major~     assessments at study entry and then 6 months and 12 months later. The primary aim of the~     study is to compare the effects of ISTS and UC on post-concussive symptoms and emotional~     distress at the 6-month assessment. The investigators predict that participants who receive~     ISTS will report lower levels of post-concussive symptoms and emotional distress at the~     6-month assessment. Secondary aims include comparing the longer term effects of ISTS and UC~     at the 12-month assessment, as well as comparing their effects on other outcomes such as~     post-traumatic stress symptoms, quality of life, resilience, and work activity.~   "
127440|NCT01387477|"~     Tight glucose control in intensive care has become a major concern, allowing a reduction in~     morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which~     can have severe consequences on the brain. The bispectral index (BIS) is derived from the~     EEG and measures of brain electrical activity noninvasively. It has already been shown that~     its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal~     response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case~     in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of~     glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a~     substrate for gluconeogenesis and an energy substrate during critical situations. It has~     been shown to improve neurological tests during hypoglycaemia and had cerebral protective~     properties after a severe head injury. The hypothesis of this study is that sodium lactate~     is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic~     variation, brain function and hormonal response.~   "
127441|NCT01387464|"~     The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium~     in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to~     routine cataract surgery.~   "
127442|NCT01387451|"~     Retrospective studies have combined positron-emission tomography and computed tomography~     (PET-CT) to identify adipose tissue with a high rate of uptake of~     18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy~     specimens and immunohistochemical staining with a UCP1-specific antiserum were used to~     indicate that normal adults were able to have BAT. However,these studies only chose few~     subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in~     different parts of adults and analyse the clinical factors.~   "
127443|NCT01387438|"~     Previous studies have shown that active brown adipose tissue (BAT) is present in adults and~     may play important roles in material and energy metabolism. However, most of these studies~     were tumor-based populations and retrospective study. Due to the large amount in our cohort,~     the investigators are able to promote a cross-sectional study of the incidence and factors~     of BAT in adult chinese. In addition, the investigators can analyse the metabolic profiles~     in healthy adults with active BAT.~   "
127444|NCT01387425|"~     Objectives~      This protocol is intended to provide information regarding the efficacy and safety of the~     nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking~     cessation in diabetic subjects who smoke. Given that a better understanding of predictors of~     smoking cessation can be useful in identifying potential quitters and likely relapsers and~     that little is known about these predictors in diabetics, the role of different predictors~     of abstinence at the end of the study will also be examined Study Population The study will~     enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and~     motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design~     The study is a double-blind, placebo-controlled, randomized clinical trial designed to~     assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking~     cessation. The duration of active treatment will be 12 weeks and subjects will be followed~     in the nontreatment phase for an additional 12 weeks. This clinical study has an optional~     research component to prolong the follow up in the nontreatment phase for a full year.~     Predictors of abstinence at the end of the study will also be examined Study Endpoints~     Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success~     rates will be defined as the Continuous Quit Rate since last visit. Subjects will be~     classified as responders if they are able to maintain abstinence from cigarette smoking~     during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This~     measure will be obtained through reports of cigarette use by means of the Nicotine Use~     Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide~     concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success~     rates at week 12 in the varenicline vs placebo group. Success rates will be defined as~     Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as~     responders if they are able to maintain complete abstinence from cigarette smoking in each~     of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory~     exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette~     use by means of the Nicotine Use Inventory during the last four study visits (week 9, week~     10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon~     monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success~     rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the~     Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44).~     Subjects will be classified as responders if they are able to maintain abstinence from~     cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤~     10 ppm. This measure will be obtained through reports of cigarette use by means of the~     Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44)~     confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that~     is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of~     predictors of smoking cessation can be useful in identifying potential quitters and likely~     relapsers and that little is known about these predictors in diabetics, the role of~     different predictors of abstinence at week 24 and at week 52 will also be examined~   "
127445|NCT01387412|"~     The primary objective of this study is to determine the role of genital warts (GW) on Human~     Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The~     secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive~     MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.~   "
127446|NCT01387399|"~     The purpose of this phase I study is to determine the safety, feasibility, maximum tolerated~     dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as~     Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with~     Platinum-Sensitive Recurrent Ovarian Cancer.~   "
127447|NCT01387373|"~     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second~     week in combination with systemic capecitabine and in patients with a HER2-positive tumour~     in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases~     from breast cancer.~      Only patients without extrahepatic disease are included.~   "
127448|NCT01387360|"~     This clinical study has been planned to determine the effectiveness of a special laser~     treatment intended to correct both near and distance vision in patients who have undergone~     previous cataract surgery.~   "
127450|NCT01387334|"~     Resistance exercise is effective in improving glycemic control in diabetes patients. The~     effectiveness of a home-based resistance exercise program has not been establish.~   "
127459|NCT01387217|"~     This protocol describes the first administration of GSK2018682 to humans. The study will~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending~     doses of GSK2018682. The study will also provide preliminary evidence of the potential~     therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte~     counts.~   "
127460|NCT01387204|"~     GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2~     activation and kinase activity currently being developed for the treatment of malignant~     melanoma. This is a Phase I, open-label, non-randomized, single-dose study designed to~     characterize the absorption, distribution, metabolism, and elimination (ADME) of a single~     oral dose of MEK inhibitor [14C]GSK1120212 as a solution in male subjects with solid tumor~     malignancies. A sufficient number of subjects will be enrolled to complete approximately~     four evaluable subjects. Following completion of the study, subjects may elect to continue~     dosing with GSK1120212 in the rollover study, MEK114375.~   "
127461|NCT01387191|"~     The objective of this study is to evaluate the incidence of adverse events in Japanese~     pulmonary arterial hypertension subjects treated with epoprostenol injection based on~     prescribing information under the conditions of general clinical practice and also to grasp~     the following items;~        1. Unknown adverse reactions (especially, significant adverse reactions)~        2. Adverse reaction onset status under practical drug use conditions~        3. Factors possibly influential on safety~        4. Factors possibly influential on efficacy~        5. Patient's prognosis, efficacy and safety in long-term use~   "
127462|NCT01387178|"~     Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation~     caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in~     COPD appears to be irreversible, evidence suggests that the course of COPD can be altered~     through measures such as smoking cessation, pulmonary rehabilitation, and the use of~     pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to~     reduce the incidence of acute exacerbations and the associated hospitalizations and~     emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be~     accomplished with the long-acting anticholinergic tiotropium (TIO), long acting~     beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or~     combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g.~     fluticasone propionate/salmeterol [FSC]).~      The objective of this study is to compare the benefits of combination long-acting~     beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The~     study compares the risk of COPD exacerbations and COPD-related healthcare utilization and~     costs for commercially-insured patients age 40 and older who were prescribed FSC to those~     prescribed TIO. The null hypothesis is that no difference exists between the costs and~     outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis~     is that patients treated with either TIO or FSC will incur lower costs and use fewer~     healthcare resources for the management of COPD.~      The source of data for this study was the Ingenix Impact database (formerly the Integrated~     Healthcare Information Services [IHCIS] database). This is an administrative claims database~     that includes patient-level data on enrollment, facility, professional, and pharmacy~     services from approximately 50 million patients covered by more than 40 managed care health~     plans across the United States (US).~      The study design is a retrospective cohort study.~   "
127463|NCT01387165|"~     The DEAL (Diabetes En America Latina) study was a multicenter, cross-sectional,~     epidemiological, questionnaire based study carried out between October 2004 and October 2005~     in 9 Latin American countries.~   "
127464|NCT01387152|"~     Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a~     nuclear isotope during a stress on the heart that permits taking pictures of the heart~     muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of~     the nuclear isotope than standard protocols, by utilizing a new, more efficient camera~     (called an Alcyone camera) which could decrease radiation dose to patients while still~     providing excellent clinical information. Subjects will undergo imaging under the Alcyone~     camera after undergoing stress testing with exercise or a standard medication simulating~     exercise, and then at rest if needed. Subjects will have follow-up to measure events~     occurring after the test, such as death, heart attack, unstable angina, repeat emergency~     department visit for chest pain evaluation, or repeat imaging needed to evaluation for~     coronary artery disease. Radiation doses and quality of the images from the imaging with the~     new protocol will be recorded to compare to those used in standard nuclear imaging~     protocols. The primary study hypothesis is that greater than 90% of patients who have a~     normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3~     months after study of death, nonfatal myocardial infarction, unstable angina, and repeat~     emergency department visit for chest pain evaluation or repeat anatomical or functional~     cardiac imaging.~   "
127465|NCT01387139|"~     The purpose of this study is to compare the effectiveness of the co-administration of~     intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural~     sedation in the pediatric emergency department. The investigators hypothesize that patients~     receiving co-administration of ketamine and propofol will have a lower rate of adverse~     events, compared to patients receiving ketamine for procedural sedation.~   "
127466|NCT01387126|"~     The aim of this study is to investigate whether the supplementation of a medically~     supervised weight management program with a novel fibre supplement, improves body weight,~     body composition, and laboratory measurements in overweight and obese individuals. All~     subjects will participate in the medical weight management program however the intervention~     group will have 5 grams of a novel fibre supplemented to each meal while the control group~     will not.~   "
127467|NCT01387113|"~     This is an open label single center phase II trial, evaluating the utility of 64 slice CT~     perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which~     aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA)~     in AIS patients up to 6 hours after symptom onset.~   "
127468|NCT01387100|"~     The purpose of this study is to explore the effects of a brief vocational rehabilitation~     intervention on individuals with arthritis who are concerned about their ability to remain~     employed.~   "
127469|NCT01387087|"~     The objective of the study is to explore safety and tolerability of single ascending doses~     of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and~     pharmacodynamics in healthy volunteers.~   "
127470|NCT01387074|"~     This is a prospective, non-interventional, observational study to collect data on the use of~     botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.~   "
127471|NCT01387061|"~     Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains~     controversial. The aim of this study was to investigate the outcome of a consecutive cohort~     of patients resected for multiple HCC, without macrovascular invasion, in order to identify~     clinically reliable parameters to select patients for surgery.~   "
127472|NCT01387048|"~     The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no~     therapy on the maintenance of clinical therapy success in subjects with mild to moderate~     acne vulgaris previously treated for 3 months by a monotherapy of this substance and to~     assess the effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and~     safety during a 9-month long-term treatment period.~   "
127473|NCT01387035|"~     The purposes of this study are (I), to evaluate various screening methods for their ability~     to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to~     evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma~     patients.~   "
127474|NCT01387022|"~     The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In~     the absence of an effective vaccine, focus has shifted to other prevention strategies such~     as pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was~     developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of~     Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In~     antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz~     has been classified as a preferred regimen in the Department of Health and Human Services~     treatment guidelines[4], and has been adopted by the South African Department of health as~     the first line regimen in treatment-naïve HIV infected patients since April 2010. The~     durability of antiviral response, favourable resistance profile, once daily dosing, and~     excellent long term safety profile of tenofovir [5], makes this drug an attractive option in~     both treatment and prevention regimens and its long half-life [6], made it an ideal choice~     as the first antiretroviral drug to be formulated as a microbicide gel.~      The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of~     1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV~     acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been~     concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to~     the potential for selection of viral mutations and development of resistance in patients who~     have become HIV-infected while on PrEP.~      There have been no studies conducted to determine whether using tenofovir in pre-exposure~     prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of~     the first line ART of South Africa.~      This study aims to determine whether prophylactic exposure to tenofovir gel alters the~     therapeutic response to a tenofovir containing antiretroviral regimen.~   "
127475|NCT01386021|"~     The primary objective of this observational study is to evaluate the function (patency) of~     cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for~     patients with occlusive coronary artery disease.~   "
127476|NCT01386008|"~     The purpose of this study is to evaluate the performance of the investigational CooperVision~     silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to~     30 days of daily lens wear.~   "
127477|NCT01385995|"~     The investigators performed a randomized, cross-over controlled clinical trial comparing 8~     weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with~     moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A~     rigorous assessment of metabolic responses to SDB treatment in this group is of great~     clinical significance because this sample is at high risk for developing diabetes. The~     paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of~     both primary care and sleep medicine.~   "
127478|NCT01385982|"~     Clinically significant test results require timely clinician follow-up including the~     non-urgent clinically significant, or actionable, test results that have received less~     standardized management and attention. Unfortunately, failure to correctly manage actionable~     test results is not infrequent and may be associated with important delays in diagnosis and~     treatment and patient harm. The investigators have designed a safe practice intervention to~     improve the management of actionable test results for ambulatory patients in a large~     healthcare system.~   "
127479|NCT01385969|"~     The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs~     and allowing them to recoil will put the pressure of the LMA cuff within the safety range.~     It will also determine if remaining within this safety range has an effect on complications~     after surgery..~   "
127480|NCT01385956|"~     The goal of this clinical research study is to learn if the study drug SOM 230 in addition~     to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The~     safety and tolerability of different doses of SOM 230 will also be studied. The~     participants' physical state, changes in the size of the tumor, and laboratory findings~     taken while on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM~     230 is safe and effective.~   "
127481|NCT01387009|"~     The primary objective is to establish normative data for Canadian children for the shoulder,~     elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons~     surrounding the joint.~   "
127482|NCT01386996|"~     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler~     with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the~     bloodstream.~   "
127483|NCT01386983|"~     This retrospective study aims to assess the clinical and economic impact of early initiation~     of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP)~     receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to~     late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford~     Health System databases will be utilized for this study (2000-2008).~   "
127484|NCT01386970|"~     This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in~     men versus women and in those with versus without HIV infection. Additionally, markers of~     side effects were correlated with blood levels of the drugs. The hypothesis was that women~     and those with HIV would have higher drug levels, as well as markers of side effects.~   "
127485|NCT01386957|"~     Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in childhood.~     Currently, all children with INS are treated at onset with steroids. The optimal duration~     and dosage of steroid therapy is debated. For each patient, the challenge is to minimise~     potential side effects of steroids, while achieving a good clinical response.~      The aim of our study is to assess the benefits and potential adverse effects of a prolonged~     initial corticosteroid regimen, for the treatment of the initial episode. The results will~     be compared with data obtained retrospectively. In addition genetic studies will be~     undertaken with the aim of evaluating pharmacodynamics of steroid treatment with the~     ultimate goal to individualise treatment in single patients.~        1. Study group: children aged 6 months - 18 years, diagnosed with an initial episode of~          idiopathic nephrotic syndrome~        2. Control group: data of children with a onset INS between January 2007 and December 2009~          from the same area of the study group and treated with a short steroid regimen will be~          retrospectively analysed and compared~   "
127486|NCT01386944|"~     The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome~     (RLS) symptoms and augmentation in patients with augmentation associated with previous oral~     dopaminergic therapy. In addition, the change in treatment regimen used when switching to~     Neupro® will be evaluated.~   "
127487|NCT01386931|"~     This study is a multicenter prospective randomized controlled trial. Potential participants~     in this study include patients referred for Endoscopic Ultrasound-guided fine needle~     aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If~     the patient meets inclusion criteria and signs the informed consent, they will be randomized~     into one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or~     without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site~     cytopathologist arm will have the cytopathologist dictate the number of fine needle~     aspiration (FNA) passes performed by the endosonographer. This number will be based on the~     adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm,~     in the absence of an on-site cytopathologist, the endosonographer will perform a~     predetermined number of 7 passes (standard of care in the absence of an on-site~     cytopathologist). The technique of performing EUS-FNA (needle type, use of stylet, suction)~     will be standardized among all endosonographers in order to rule out confounding factors.~     After EUS-FNA is performed all slides will be sent to the pathology department. The slides~     will be sent for review regardless of which arm the patient is randomized into, and they~     will be reviewed by experienced cytopathologists for the purpose of determining the final~     diagnoses.~      Future clinical intervention will be monitored for the purpose of reporting the impact~     EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients~     will be followed prospectively for at least one year, and the gold-standard for final~     diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or~     histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging~     follow-up consistent with pancreatic cancer (death or clinical progression). A detailed~     account of medical equipment used during each procedure, procedure time, clinic~     visits/hospitalizations due to procedure related complications, and number of repeat~     procedures will be recorded systematically.~      The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic~     masses improves diagnostic yield, accuracy, and lowers the duration, complications and the~     need for repeat procedures.~   "
127488|NCT01386918|"~     Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for~     refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of~     studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz)~     to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation~     (hereby simply referred to as priming) has been shown to enhance the neurophysiological~     effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore,~     this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to~     the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).~   "
127489|NCT01386905|"~     The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™)~     when used to treat obesity.~   "
127490|NCT01386892|"~     This study seeks to obtain normal samples of blood, saliva and urine to serve as controls~     for other approved protocols and for analysis. These include determination of the functional~     capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral~     blood including plasma, serum and cellular fraction from normal individuals. Saliva and~     urine will have similar testing which may also be compared to the blood testing results. The~     ongoing objective varies from investigation to investigation but in general the~     investigational goals are to better understand the immune function of normal volunteers and~     compare it to immune function in disease states.~   "
127491|NCT01386879|"~     The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation,~     amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug~     Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia~     in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a~     significant reduction in the incidence of ventilator acquired pneumonia when a ETT with~     suction above the cuff is used to remove secretions that accumulate above the inflated cuff.~     This will be the first study to evaluate the efficacy of above the cuff suctioning during~     general anesthesia and surgery.~      One hundred and ten adult patients undergoing elective abdominal surgery (general,~     colorectal or gynecological) requiring general anesthesia with an endotracheal tube and~     mechanical ventilation will be randomized into 3 groups to receive one of the following~     three endotracheal tubes:~        1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port~          Endotracheal Tube (Teleflex ISIS ETT).~        2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).~        3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)~      The first two groups will be compared to standard ETT (third group) regarding easy of~     tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea~     with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the~     pharynx into the trachea and incidence of post-operative respiratory complications.~   "
127492|NCT01386866|"~     In order for a tumour to grow and spread to other parts of the body, it needs to have a~     blood supply. Certain proteins in the body, called cytokines or growth factors, have been~     shown to cause the growth of new blood vessels that supply tumours and therefore help the~     tumour to grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may~     help to prevent the growth of tumours.~      In the first part of this study, we will look at the way your body absorbs this drug into~     your blood, how your body changes and breaks down the drug, and then how the drug leaves~     your body in your urine and faeces.~      In order to provide potential treatment benefit for the subjects who participated in the~     first part of the study, the second part of the study will allow subjects to continue on~     motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown,~     and dependent on how subjects respond to motesanib (AMG 706).~   "
127493|NCT01386853|"~     This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority~     study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and~     atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.~   "
127494|NCT01386840|"~     The purpose of this study is to determine the safety and efficacy of oral amoxicillin in~     treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing)~     at home and at hospital using an open labelled multicentric prospective two-arm randomized~     clinical trial to determine the differences in failure of treatment with a 7 day course of~     oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent~     home after enrolment, in children 3 to 59 months old who have severe pneumonia. The~     investigators developmental hypothesis were to test whether the community/home based oral~     amoxicillin is efficacious for treating severe pneumonia.~   "
127563|NCT01385839|"~     The purpose of this study is to look at the safety, as well as the efficacy of hair~     transplantation compared with irritation with hypodermic needles in the treatment of~     subjects with refractory alopecia areata.~      With this study, the investigators hope to demonstrate that trauma is just as effective as~     hair transplant in the treatment of recalcitrant alopecia areata of the scalp.~   "
127495|NCT01386827|"~     The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to~     cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The~     present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.~      Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune~     responses in four groups: A) primary immunization with BMJEV, B) primary and secondary~     immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization~     with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help~     of serum samples collected before and after vaccination.~   "
127496|NCT01386814|"~     Aim: To evaluate the influence of oxygen deficit on the cognitive performance and also about~     the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise~     in a hypobaric chamber. SUMMARY: Participants in this study 30 healthy male volunteers, aged~     20 to 40 years, regular physical activity, constituting three groups: 1 - without~     exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise~     in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of~     10 volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise~     and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the~     same in condition of hypoxia (hypobaric chamber). All groups on the first day of the~     experiment will undergo baseline assessments, laboratory blood analysis salivary and~     spirometric testing. Assessments will be personality and neuropsychological. After baseline~     assessments, the last day of the experiment, the groups will be evaluated again 4350m above~     sea level the sea, by personality tests, neuropsychological and laboratory. RATIONALE AND~     BACKGROUND: During exposure to environments with a partial reduction of oxygen, human body~     can undergo several physiological and psychological changes are not prepared for such~     condition. Few studies have reported that the elevation changes and cognitive aspects~     related to sleep.~      MATERIAL AND METHOD: They describe the procedures to be performed, and the study conducted~     in local with adequate infrastructure.~   "
127497|NCT01386801|"~     Blood samples and health information (e.g., age at diagnosis, test results) are collected~     for the purposes of genetic research. The blood samples are assigned a number and stored in~     a repository for safe keeping until they are needed for a research project. Participants are~     persons who are healthy (not having high blood pressure, diabetes, or high cholesterol~     levels) or persons who have Diabetes Mellitus Type II(T2D) and live in Indiana. Participants~     complete a questionnaire at the time the blood sample is drawn. Visits are repeated at 2 and~     5 years after initial contact. Researchers apply to the Fairbanks Institute for use of the~     blood samples and health information minus participant names and contact information. Their~     research is required to be related to find genes or substances made by genes that may be~     involved in Diabetes Mellitus Type II with the purpose of improving the investigators~     understanding of the illness potentially leading to the development of new diagnostic tools~     for identifying the illness, new treatments,or preventative measures.~   "
127498|NCT01386788|"~     Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial~     or laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas~     (e.g. in the case of fire) or salts in the case of suicide attempts.~      In fact, cyanide poisoning is considerably more common than is generally appreciated.~     Multiple clinical and post-mortal studies have demonstrated that HCN contributes to the~     toxicity of fire smoke.~      Cyanide acts primarily through its strong affinity for the iron-containing heme moiety,~     binding to numerous critical enzyme systems in the body and rendering them inactive. Of~     late, increasing attention has been paid to the relationship of cyanide and nitric oxide.~     The interactions appear to be complex, with cyanide inducing nitric oxide production by~     binding to N-methyl-D-aspartate (NMDA) receptors, as well as binding to nitric oxide~     synthase. The latter may be overcome by the presence of nitric oxide synthase inhibitors.~      Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in~     closed-space fires.~      So far, there are no clear data available on the prevalence of cyanide poisoning in smoke~     inhalation.~      This information would be of great interest for all emergency physicians since a proven or~     supposed cyanide poisoning does not only requires an intensive supportive care, including~     the administration of supplemental oxygen and artificial ventilation, blood pressure~     support, and anticonvulsants, but also a rapid administration of a cyanide antidote.~      Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in~     smoke inhalation victims. Only the data of patients with a cyanide measurement before~     specific antidote treatment will be included~   "
127499|NCT01386775|"~     This study in affected Hypohidrotic Ectodermal Dysplasia (HED) males and unaffected male~     controls, age 1 year and up, will use minimally invasive devices to image sweat ducts in~     intact skin, to measure stimulated sweat rate, and in a subset of subjects to collect~     clipped scalp hair samples for RNA analysis. This study is descriptive in nature and is~     intended to assess the ability to use innovative approaches to generate data from subjects~     over a wide age spectrum, with particular emphasis on phenotype variability between male~     siblings (same mutation).~   "
127500|NCT01386762|"~     Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments~     used to reverse this condition have equivocal effectiveness. The aim of this study is to~     determine the effect of intense multi-modal training on bone health, body fat, and quality~     of life in persons with SCI. Participants will complete 6 months of training during which~     various measures will be obtained at 0, 3, and 6 months. Control subjects are also being~     recruited to complete testing but not participate in training.~   "
127532|NCT01386320|"~     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and~     is very painful. Local anaesthetic nerve blocks have been used for many years to help~     alleviate pain following this surgery. The present study aims to compare a new ultrasound~     guided nerve block to a well established nerve stimulator guided technique. Comparisons will~     include time taken to carry out the block, speed of onset of numbness and duration and~     quality of pain relief after surgery.~   "
127533|NCT01386307|"~     The purpose of this study is to determine the prevalence of patients with acute and chronic~     pain in the area of inpatient at the Hospital Italiano de Buenos Aires.~   "
127534|NCT01386294|"~     The purpose of the study is to assess the safety and effectiveness of intravaginal 1%~     tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes~     Simplex Virus (HSV-2) infection in sexually active women.~   "
127501|NCT01386749|"~     Diaphyseal long bone fractures are usually associated with high energy trauma in which~     femoral shaft fracture is one common fracture in young age group. Surgery is usually needed~     for the diaphyseal lone bone fractures and the painful conditions always hinder weight~     bearing which is important for fracture healing and functional recovery. Fracture healing in~     cortical bone is less predictable than trabecular bone because they are less active and~     blood supply is more critical. Therefore accelerating fracture healing and rehabilitation of~     long bone fracture will absolutely bring significant economic benefit to the society in term~     of hospitalization and sick leave cost.~      Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical~     stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can~     enhance the blood circulation and osteogenic effect in normal subjects and animals. Our~     previous clinical study also indicated that LMHFV could enhance the balancing ability and~     muscular function in normal post-menopausal women after treating whole-body vibration. For~     the fracture healing effect, an acceleration of healing by inducing callus formation and~     maturation in rat model was also reported in our previous studies.~      In this study a total of 50 unilateral closed femoral shaft fracture patients of either~     gender aged 20-40 years old will be recruited and they will be randomized to either control~     and vibration group. The vibration group will be treated with LMHFV for 6 months. The~     findings of this study will provide very useful scientific data to support the application~     of LMHFV for fracture healing.~   "
127502|NCT01386736|"~     The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates~     that the physiologic functions of vitamin D are much broader than its well-known role in the~     regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is~     involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type~     I diabetes. Recent epidemiological evidence points to a strong association between vitamin D~     insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The~     investigators would like to examine the role of vitamin D in the development of insulin~     resistance in overweight children and adolescents, which represent a high risk population~     for cardiovascular and metabolic complications. The investigators propose a prospective~     randomized clinical trial of vitamin D supplementation in overweight, insulin resistant,~     vitamin D deficient children. The investigators objective is to assess if changes in insulin~     resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these~     patients post treatment with vitamin D. Additionally, concomitant changes in calcium and~     bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to~     adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have~     not been established in pediatrics.~   "
127503|NCT01386723|"~     This study proposes to observe whether a stable platelet count would be maintained without~     additional treatment in the long term in at least a proportion of patients who have~     discontinued eltrombopag taken for at least 4 months. This requires that if patients stop~     treatment with eltrombopag, they are not immediately transitioned to further treatment~     unless it is necessary.~      The objective of the study is to assess how frequently patients who have discontinued~     eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8~     weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).~   "
127504|NCT01386710|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of~     either surgical resection, external beam radiation or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if~     currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The~     investigators have shown in a previous phase I trial that a single Superselective~     Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective~     in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an~     extension of that trial in that the investigators seek to test the hypothesis that repeated~     dosing of intra-arterial Bevacizumab is safe and effective in the treatment of recurrent~     malignant glioma. Additionally the investigators will analyze if a combination with IA~     Carboplatin will further improve the treatment response. By achieving the aims of this study~     the investigators will also determine if IV therapy with Bevacizumab with IV Carboplatin~     should be combined with repeated selected intra-arterial Bevacizumab plus Carboplatin to~     improve progression free and overall survival. The investigators expect that this project~     will provide important information regarding the utility of repeated SIACI Bevacizumab~     therapy for malignant glioma, and may alter the way these drugs are delivered to the~     investigators patients in the near future.~   "
127505|NCT01386697|"~     The overall objective is to estimate the actual or potential benefit of deep inspiration~     breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3~     dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy~     (IMXT), as it relates to variability in tumor localization, treatment margins, target volume~     definition, doses to organs at risk and variations with treatment planning.~   "
127506|NCT01386684|"~     The purpose of this study is to evaluate the Canadian Real Life Evaluation of the~     Effectiveness of Lupron in the Management of Prostate Cancer.~   "
127507|NCT01386671|"~     The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus~     Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican drug~     naïve type 2 diabetes patients, in a 12 months follow up.~   "
127508|NCT01386658|"~     HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the~     Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single~     subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with~     Hereditary Angioedema (HAE) during an initial acute attack.~   "
127535|NCT01386281|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Julina for postmenopausal~     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina~     in clinical practice. A total 100 patients will be recruited and followed 3 years since~     starting Julina administration.~   "
127509|NCT01386645|"~     The study will determine if increasing the highs and lows of blood glucose levels (glycemic~     variability) impairs insulin secretion in people with impaired glucose tolerance and/or~     impaired fasting glucose who are at risk for developing type 2 diabetes. Furthermore, the~     study will determine whether changes in beta-cell function are associated with glycemic~     variability and whether they are mediated by oxidative stress. To decrease or increase~     glycemic variability the study will provide subjects with special diets containing either~     low or high glycemic index foods respectively for 4 weeks. To determine if oxidative stress~     is a mediator, subjects on the high glycemic index diet will take either placebo or the~     anti-oxidant N-acetylcysteine. The study will address the hypothesis that increased glycemic~     variability results in increased oxidative stress and thereby exacerbates beta-cell~     dysfunction in individuals with impaired glucose tolerance and/or impaired fasting glucose.~     The findings may have important implications for the development of effective strategies~     aimed at the prevention and treatment of type 2 diabetes. In addition, understanding the~     contribution of dietary glycemic index to beta-cell dysfunction in subjects with~     pre-diabetes may have a significant public health impact, including changes to dietary~     counseling and promotion of healthier eating patterns.~   "
127510|NCT01386632|"~     This will be a randomized masked placebo-controlled single-center study to evaluate the~     effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and~     radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and~     Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or~     matching placebo given with standard of care treatment consisting of Cisplatin and radiation~     treatment.~      Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6~     patients of the total study population will represent a safety lead-in cohort. The results~     of the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy~     will be evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of~     patients will be withheld during safety data analysis.~   "
127511|NCT01386619|"~     This is a phase I/II study of highly selected donor lymphocyte infusions in patients~     undergoing HLA-haploidentical hemopoietic stem cell transplantation. Patients will be~     offered pre-emptive NK-DLI early after HSCT.~      Three schedules of NK-cell infusion will be studied: Basel patients (adult and pediatric)~     will receive NK-DLI on days +40 and +100 (pre-emptive-late); Frankfurt patients (pediatric)~     will receive NK-DLI on days +3, +40, and +100 (pre-emptive early). Patients not receiving~     pre-emptive NK-DLI with loss in donor chimerism or with evidence of minimal residual disease~     will be offered therapeutic NK-DLI.~   "
127512|NCT01386606|"~     The study will determine the effects of three doses of Androxal(enclomiphene citrate)on~     morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone~     (<350 ng/dL)after 6 weeks of continuous dosing.~   "
127513|NCT01386593|"~     The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a~     cocktail of six approved drugs (so-called Basel cocktail) change when the cytochrome P450~     system is inhibited or induced.~   "
127514|NCT01386580|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics~     (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the~     study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients~     with with solid tumors and brain metastases or recurrent malignant glioma as well as in~     patients with various forms of breast cancer with and in combination with trastuzumab in~     HER2+ breast cancer patients with brain metastases.~   "
127515|NCT01386567|"~     The purpose of this study is to determine the continued effects of Androxal on morning~     testosterone and reproductive status in men with secondary hypogonadism who have completed~     protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim~     (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5~     mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the~     lower dose.~   "
127516|NCT01386554|"~     The purpose of this study is to provide nephrologists with additional clinical evidence~     regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic~     membranous nephropathy. Approximately sixty (60) subjects will be randomized in this~     double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and~     Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week~     observation period. The primary objective of this study is to assess the proportion of~     treatment-resistant subjects (defined as subjects who either have had no response or have~     suffered a relapse after achieving a partial response to their most recent standard~     treatment regimen) who have a complete or partial remission of proteinuria in nephrotic~     syndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.~   "
127517|NCT01386541|"~     This monocenter trial is conducted to obtain first data on safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677~     in humans. In addition, the trial should provide preliminary information on a possible~     influence of sex, food intake, and posology (once or twice daily administration of~     BYK324677) to support the further planning of the drug development programme.~   "
127518|NCT01386528|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog~     beta pegol) during surgical procedures in patients with haemophilia B.~   "
127536|NCT01386268|"~     To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life~     conditions in its registered indications.~      The observation period for each patient is up to 6 months.~   "
127537|NCT01386255|"~     Despite the use of proton pump inhibitors and available prokinetics, medical therapy is~     ineffective in an important number of children with CP and GERD, and failure of medical~     therapy is associated with a substantial morbidity. Many patients, particularly children~     with CP and GERD, continue to experience complications despite aggressive therapy because~     antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore,~     in patients with CP, surgical options are fraught with serious complications and long-term~     morbidity. Because the available treatment options for children with CP and intractable GERD~     are limited, new therapies are urgently needed. Baclofen, which has been shown in animals~     and humans to decrease TLESRs, may be a good alternative for the treatment of children with~     CP with intractable GERD.~   "
127519|NCT01386515|"~     Background:~      We want to learn more about the relationship between the way families function and how~     children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn~     will help us design better interventions for families.~      Objective:~        -  To learn more about how families with an individual with DMD function.~        -  To learn how siblings adapt in families with an individual with DMD.~      Eligibility:~        -  One parent and one child, age 13-18, from a family where another child has DMD.~        -  The parent and the child must be able to read and write English.~      Design:~        -  One parent from each family will complete a survey about how family members communicate~          and relate with each other. The parent will also answer questions about the behavior of~          the child without DMD. This survey will take you about 40 minutes to complete.~        -  One child from each family, either a boy or a girl, will also complete a survey. This~          survey asks about how he/she views him/herself. It also asks about how he/she interacts~          with peers and family members and how he/she behaves. The survey also asks how~          satisfied he/she is with how his/her family functions. This survey takes about 30~          minutes to finish.~   "
127520|NCT01386502|"~     Background:~        -  The p53 gene normally helps to stop cancer cells from growing. However, when the p53~          gene is mutated or damaged, cancer cells may grow unchecked. Researchers have been~          working on a vaccine that will help the immune system recognize and destroy cells that~          have the p53 mutation and may be cancerous.~        -  CT-011 is another drug that may help the body's immune system to fight cancer. This~          drug blocks a chemical found on tumor cells that prevents the immune system from~          recognizing and destroying them. Research studies have shown that CT-011 slows the~          growth of tumors. By combining the p53 vaccine and CT-011, researchers hope to slow or~          stop tumor growth in people whose cancer that has not responded to standard treatments.~      Objectives:~      - To test the safety and effectiveness of CT-011 and the p53 genetic vaccine to treat adults~     with solid tumors that have not responded to standard treatments.~      Eligibility:~      - People at least 18 years of age who have solid tumors that have not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will also~          have blood tests and tumor imaging studies.~        -  Participants will receive the p53 vaccine as an injection in the arm or thigh.~        -  Two days after receiving the p53 vaccine, those in the study will receive CT-011 as an~          infusion over about 2 hours. Participants will be monitored during the infusion for any~          side effects.~        -  The combination of p53 vaccine and CT-011 will be repeated every 3 weeks (one cycle).~          Treatment will continue as long as the side effects are not severe and the tumor does~          not grow.~        -  Three weeks after the second dose of p53 vaccine and CT-011, participants will have a~          full physical exam. They will also have blood tests, and tumor imaging studies. This~          exam set will be repeated after every two cycles of p53 vaccine and CT-011.~        -  Participants will have regular follow-up visits for up to a year after stopping~          treatment.~   "
127521|NCT01386489|"~     Background:~      The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for~     HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response~     to two experimental HIV vaccines currently in development at the VRC. One is known as the~     rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces~     of manufactured DNA. They do not contain live or killed HIV. It is impossible for study~     vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of~     these experimental vaccines have been given to people before in other research studies. They~     have not been approved for treating or preventing HIV infection.~      Purpose:~      The main purpose of this study is to look in detail at the body s immune responses after the~     experimental HIV vaccines are given and to assess safety of the study vaccines.~      Eligibility:~      Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet~     the eligibility requirements.~      Design:~      Participants will be screened with a medical history (including questions about sexual~     history and drug use), physical exam, and blood tests.~      The study will have two groups:~      <TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over~     3 months.~      <TAB>The second group will have three injections of the DNA vaccine, one injection of the~     rAd5 vaccine, and have 12 clinic visits over 6 months.~      All participants will be asked to provide blood and body fluid samples for testing during~     the study.~      Payment for participation will be provided.~   "
127522|NCT01386476|"~     Background:~      - The blood-brain barrier helps protect the brain from infections and toxins in the blood~     stream. But it can also prevent certain drugs from reaching the brain to treat diseases or~     other problems. Researchers are interested in chemicals that will help show how the barrier~     works. One possible chemical, (18F)FCWAY, may be useful for studying the barrier. More tests~     are needed to determine how effective it is.~      Objectives:~      - To test whether (18F)FCWAY can be used to help study the blood-brain barrier.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age.~      Design:~        -  This study requires a screening visit and two scanning visits.~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests.~        -  At the first scanning visit, participants will have a magnetic resonance imaging scan~          to provide baseline images of the brain.~        -  Before the second visit, some participants will stay overnight in the hospital. They~          will receive the drug tariquidar, which may help the (18F)FCWAY show the blood-brain~          barrier more clearly.~        -  At the second scanning visit, all participants will have a positron emission tomography~          scan with (18F)FCWAY to see how well the drug shows the blood-brain barrier on the~          scan.~   "
127523|NCT01386437|"~     Background:~      - The immune system is made up of special cells, tissues, and organs that fight infections.~     Problems with this system may lead to frequent, severe, or unusual fungal infections. These~     infections are often difficult to treat. Researchers want to collect blood and tissue~     samples from people who have unusual, persistent or severe fungal infections or immune~     problems that increase the risk of these infections.~      Objectives:~      - To collect medical information and samples for a long-term study of people with immune~     system problems that lead to fungal infections.~      Eligibility:~        -  People with a history of fungal infections caused by immune system problems.~        -  Parents, children, and siblings of this group.~        -  Healthy volunteers not related to the first two groups.~      Design:~        -  This long-term study may last for up to 10 years. Those in the study may need to~          provide new information about every 6 months. The procedures for each person may vary~          with the particular diagnosis and the extent of fungal infection. Healthy volunteers~          may have only one or two visits.~        -  At the first visit, those in the study will have a full medical history and physical~          exam. They will also provide blood.~        -  Research procedures may include the following:~        -  Saliva, urine or stool testing~        -  Mouthwash collection for DNA testing~        -  Collection of cheek cells, nail clippings, or vaginal fluid~        -  Tests of leftover tissue or body fluid from previous medical procedures~        -  Skin or oral mucous membrane biopsy~        -  Collection of white blood cells~        -  Followup visits will involve a physical exam and updated medical history. Blood,~          saliva, urine, or nail clipping samples may be taken for ongoing studies. Any~          additional tests or exams required by the study doctors may also be done.~        -  Participants may withdraw from the study pool at any time.~   "
127538|NCT01386242|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection in treating patients with metastatic colorectal cancer~     after failure of second-line and more than second-line treatment.~   "
127539|NCT01386229|"~     The aim of this study is to determine whether ketamine is an acceptable alternative to~     etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of~     hemodynamic stability and also to compare these agents regarding their effect on adrenal~     gland steroid synthesis in these patients.~   "
127524|NCT01386424|"~     Background:~      - Influenza (the flu) is highly infectious and contagious. It causes considerable illness in~     the United States each year. The most severely affected are the very young, sick, and~     elderly. Researchers want to find healthy volunteers for influenza challenge studies. In~     these studies, doctors expose a person to a flu virus. Then they study the flu through the~     body's natural healing process. This information will help to find better ways to prevent~     the flu. It may also improve the treatment of people who get the flu.~      Objectives:~      - To screen healthy volunteers for future influenza challenge studies.~      Eligibility:~        -  Healthy people between the ages of 18 and 65 who do not routinely smoke.~        -  People who share the same apartment or house with people at least 65 years of age or~          children under age 5 will not be eligible.~        -  People who share living quarters with nursing home residents, people with chronic or~          acute medical conditions, or people with cancer or a compromised immune system are also~          ineligible.~      Design:~        -  The 3- to 5-hour screening exam includes the following:~        -  Medical history and physical exam~        -  Standard blood tests including pregnancy and HIV tests~        -  Standard urine drug testing~        -  Electrocardiogram (ECG) to test heart rhythm and function~        -  Chest x-ray~        -  Eligible volunteers are enrolled in the study for up to 1 year, until they take part in~          a virus challenge study, or are found to be ineligible to participate.~        -  Volunteers may withdraw from the study pool at any time.~   "
127525|NCT01386411|"~     Genes are the blueprints for our bodies. Some people are born with an abnormal copy~     (mutation) of a gene. These people may have a higher chance of getting a disease.~     Different mutations in different genes cause different diseases. Some women get breast~     cancer because they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These~     women also have a higher chance of getting ovary cancer. Women with breast cancer and an~     abnormal copy of BRCA1 or BRCA2 also have a higher chance of getting a second breast cancer~     in their other breast. Because of this, women who might have a mutation may have genetic~     testing soon after their breast cancer diagnosis to learn about their risks of getting~     another cancer.~      Genetic testing may be done right after a woman has been diagnosed with breast cancer. It~     may also be done later, after surgery is done to treat the cancer. The investigators do not~     know when it is best to do genetic testing. The investigators are doing this study to try to~     understand whether women prefer testing before or after surgery. The investigator also want~     to find out how they feel about their choice later on, when their diagnosis in more in their~     past.~   "
127526|NCT01386398|"~     RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective~     when given alone or when given together with bortezomib in treating patients with refractory~     or recurrent cutaneous T-cell lymphoma.~      PURPOSE: This randomized phase III trial is studying how well vorinostat works when given~     alone compared with vorinostat given together with bortezomib in treating patients with~     refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.~   "
127527|NCT01386385|"~     This phase I/II partially randomized trial studies the side effects and best dose of~     veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see~     how well it works in treating patients with stage III non-small cell lung cancer that cannot~     be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor~     cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel,~     work in different ways to stop the growth of tumor cells either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. It is not yet known whether~     radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib~     in treating non-small cell lung cancer.~   "
127528|NCT01386372|"~     Hyponatremia is a common electrolyte disorder encountered in hospitalized patients. A~     preliminary, observational, feasibility analysis finalized to assess retrospectively the~     incidence of hyponatremia (Serum sodium < 135 mEq/L) in a general medical-surgical hospital~     and the distribution of the cases of hyponatremia among different referral units showed that~     over one year observation there were more than 1500 cases of hyponatremia. Conventional~     therapy for hyponatremia depends on its causes, speed of onset, extracellular fluid volume~     status, and severity. Treatment consists in fluid restriction, normal or hypertonic saline,~     furosemide. Recent development of arginine vasopressin antagonists has provided a new~     therapeutic option for treatment of hyponatremia.Tolvaptan, an orally administered,~     nonpeptide, selective vasopressin V2 receptor antagonist reported to increase free water~     clearance and limit fluid retention in subjects with congestive heart failure or liver~     cirrhosis, has been also shown to be effective in the treatment of chronic hyponatremia in~     patients with SIADH, chronic heart failure, liver cirrhosis. Thus the investigators designed~     a clinical study to explore the incidence of severe hyponatremia in hospitalized patients in~     the setting of large general hospital and to evaluate whether tolvaptan is effective and~     safe in increasing serum sodium concentration in patients with normovolemic and hypervolemic~     hyponatremia in the setting of daily clinical practice. Moreover this study may help~     understand the cost-effectiveness of tolvaptan therapy compared to traditional treatments of~     hyponatremia.~   "
127529|NCT01386359|"~     To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant~     Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive~     Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant~     treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.~   "
127530|NCT01386346|"~     The purpose of this study is to see whether giving azacitidine before each cycle of~     chemotherapy prior to surgery is safe.~   "
127531|NCT01386333|"~     Oxytocin is a hormone produced by the brain that appears to have important roles in social~     cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin~     on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia~     were investigated. The results from the pilot study suggested that oxytocin may be~     associated with a modest improvement in neuropsychiatric behaviours seen in patients with~     Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this~     disorder, the present study will examine the safety and tolerability of three different~     doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice~     daily for 1 week.~   "
127541|NCT01386203|"~     Analysis of volatile organic compounds (VOCs) is a new attractive non-invasive field in~     medical diagnostics. These VOCs can be detected via the exhaled breath.~      Together with Prof Haick group at the Technion Inst (Israel), the investigators data shows~     that there is a relation between the VOCs patterns of NSCLC and control cell lines and~     equivalent states in exhaled breath. The investigators demonstrated that there is a clear~     discrimination between the lung cancer and the healthy clusters . The investigators also~     analyzed the headspace of NSCLC and SCLC cell lines and the investigators could discriminate~     significantly between SCLC versus NSCLC based on their VOCs patterns. This analysis allowed~     us to identify the specific VOCs consumed or omitted by cancerous cells. Therefore, a~     non-invasive and highly sensitive test would be extremely valuable for the classification~     and early screening of lung cancer and for targeted therapy. In this study, the~     investigators will monitor the VOC pattern of patients with lung cancer as well as high risk~     cohort and patients under risk/evaluation for lung cancer. Likewise the investigators will~     monitor pts under and after therapy. In addition, the investigators will compare teh breath~     signature to other biomarkers of lung cancer, like circulating tumor cells and others.~   "
127542|NCT01386190|"~     This research consists of a novel intervention designed to increase physical activity of~     premature babies in their first year of life. The potential beneficial impact of augmented~     physical activity on:~        1. Body composition~        2. Associated biochemical and cellular mechanisms of growth and inflammation~        3. Quality of maternal care will be measured~   "
127543|NCT01386177|"~     The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a~     alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of~     3,4-methylenedioxymethamphetamine (MDMA, ecstasy). The investigators hypothesize that~     doxazosin will attenuate the cardiovascular and subjective response to MDMA.~   "
127544|NCT01386164|"~     The purpose of this study is to analyze and compare the immunogenicity of Bivalent and~     Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.~   "
127545|NCT01386151|"~     This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner~     lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown~     in asthmatic patients by other studies, not only in the lung but also possibly in the gut,~     perhaps reflecting a widespread defect. This leakiness may underline the interaction between~     the environment and a person's genetic make up, and may contribute to why some people get~     asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled~     allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark~     of asthma.~      Specifically, this study will attempt to modify and reduce this permeability through the use~     of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring~     human protein, which is involved in stimulating the growth of cells lining the layers of the~     skin and gut, helping to repair damage and maintain their structure. It has been~     manufactured in a laboratory as the commercial compound 'Palifermin', which has already been~     used in humans to reduce damage to the lining of the mouth after chemotherapy. The study~     will see if Palifermin can similarly improve the lining of the lung in asthma patients and~     improve their symptoms. To date no treatments have been used in this area in asthma, and if~     successful the study will open up a whole new area of therapy~   "
127546|NCT01386138|"~     The purpose of this study was to develop and initially evaluate an efficacious,~     comprehensive, culturally sensitive, women-centered model of care for pregnant South African~     women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the~     same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's~     Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.~   "
127547|NCT01386125|"~     This study will evaluate the effectiveness and safety of MFNS in improving nasal~     congestion/obstruction and in reducing bilateral nasal polyps.~   "
127548|NCT01386112|"~     Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by~     eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological~     treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by~     published case series and controlled trials in children and adults, the most widely used~     drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal~     mucosal) action.~      This study will evaluate the safety and tolerability of orally administered EUR-1100 once or~     twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The~     Treatment Period will be 8 weeks during which subjects will visit the clinic at the~     screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical~     symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and~     week 6.~   "
127549|NCT01386099|"~     The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of~     PSN821 in patients with type 2 diabetes.~      Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the~     start of treatment and at the end of a 12 week treatment period as the primary endpoint.~     HbA1c, fasting plasma glucose and body weight are secondary endpoints.~   "
127550|NCT01386086|"~     Currently there are no controlled data on the management of postpartum depression that fails~     to respond to adequate antidepressant therapy. The investigators recently reported that a~     large number of patients responded to the addition of atypical neuroleptics after having~     failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective~     in patients with resistant depression but it has not been studied in patients with resistant~     postpartum depression. The investigators propose to conduct a 6 week open-label study to~     assess the effectiveness and tolerability of aripiprazole used adjunctively to~     antidepressants in patients with resistant postpartum depression.~   "
127551|NCT01386073|"~     The purpose of this study is to compare the efficacy of FreshKote and Systane for the~     reduction of dry eye signs and symptoms.~   "
127552|NCT01386060|"~     The study purpose is to evaluate efficacy of a mindfulness training intervention and learn~     about cognitive and physiological markers of stress.~   "
127611|NCT01385202|"~     The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL®~     SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug~     refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology~     mapping and RF procedures.~   "
127553|NCT01386047|"~     Clinical prediction rules (CPRs) are frontline decision aids that help physicians make~     evidence-based, cost-effective decisions that benefit their patients. The aims of this~     project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction~     Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical~     Record System (EMR) and to perform a randomized controlled trial of the effectiveness of~     integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication~     prescribing).~   "
127554|NCT01386034|"~     The specific aim of this study is to determine whether oral citrulline administration~     enhances whole body protein synthesis in patients with intestinal failure. Protein~     metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine.~     The investigators hypothesize that citrulline supplementation will decrease leucine~     oxidation without altering proteolysis, and consequently stimulate protein synthesis.~   "
127555|NCT01385943|"~     The goal of this study is to test a protocol that uses clinical pictures, confocal~     reflectance microscopy images and dermoscopic information in a telemedicine platform. This~     protocol will test the technologies and diagnostic performance of dermoscopy and confocal~     reflectance microscopy in a randomized prospective multicenter study in five different~     centers in Europe.~   "
127556|NCT01385930|"~     The aim of the study is to evaluate self-reported adherence to and the effects of an~     intervention model consisting of individualized prescribed dietary advice (DAP) in~     combination with Motivational Interviewing (MI), social support and mobile services in obese~     patients in primary health care. The specific aim is to relate effects of the intervention~     model to self-reported health, biomarkers for coronary heart disease, diabetes, some cancer~     forms, sleep duration and quality, health economy, oral health, dietary intake and physical~     activity.~      This is a two-armed randomized controlled study. The arms are: 1) Control group (care as~     usual) and 2) Experimental group (MoR). The volunteers will be consecutively, for each sex,~     randomized to the experimental and the control group, respectively.~      The experimental group will receive DAP together with Motivational interviewing up to six~     months after the start of the study. From six months up to 24 months the participants will~     receive social support online and mobile services.~      The control group will receive dietary information according to the Habo model. The~     previously mentioned diet will be recommended to both the control group and the experimental~     group since it is the method in which the investigators give the information they want to~     study and not the diet per se. Thus, it is only the way the investigators give dietary~     information that differs between the groups.~      The study also includes qualitative interviews. The aim of these studies is to gain~     understanding of patients' and health professionals' experience and attitudes around food,~     lifestyle and support functions associated with dietary change. The sampling approach~     involves the purposeful selection of cases with a wide range of variation, which means that~     the researcher selects people who are able to provide rich information about the current~     issue. To achieve diversity, it is useful that both women and men are involved in the~     studies, as well as people of different ages and with different experiences of providing or~     receiving dietary advice. About 15-20 people will participate in each interview study.~   "
127557|NCT01385917|"~     PreU7-53 is a natural history study. The objective is to monitor the clinical and~     radiological course of upper limb muscle impairment in patients with Duchenne Muscular~     Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.~   "
127558|NCT01385904|"~     The purpose of this research study is to measure how much, if any, ketamine is absorbed into~     the blood stream after ketamine gel is applied to the skin. The investigators expect that~     the topical administration will provide pain relief locally, at the site of pain, but not be~     absorbed into the bloodstream and thus not cause side effects. This research will help~     assess the safety of this drug by measuring the blood concentrations of the drug.~      Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It~     has been used to relieve chronic pain by administering intravenously, by mouth, or as an~     injection beneath the skin. When given these ways ketamine can occasionally cause side~     effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been~     used topically for patients with neuropathic pain in order to avoid the dizziness and nausea~     side effects.~      Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the~     area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and~     act directly on the small nerve fibers. The advantage is that less drug will get into the~     blood circulation. Up to now, it has not been carefully studied how much of the drug appears~     in the circulation after application on the skin.~   "
127559|NCT01385891|"~     Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is~     able to induce remission in resistant/refractory acute leukemias in pediatric.~      Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute~     Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40~     mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440~     mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without~     platelet recovery (CRp) and toxicity~   "
127560|NCT01385878|"~     Cataract surgical techniques have significantly changed in recent years with the widespread~     adoption of smaller and smaller clear corneal incisions for phacoemulsification.~     Microincision surgery has many advantages, including reduced surgically induced astigmatism,~     faster visual recovery, and reduced intra and postoperative inflammation. Curently,~     microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions.~     However, there is still a debate as to which is the best absolute incision size for~     microcoaxial cataract surgery.~      The aim of this study is to evaluate incision stability following microcoaxial~     phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare~     intraoperative performance and postoperative outcomes following microcoaxial~     phacoemulsification performed through these two incision sizes.~   "
127561|NCT01385865|"~     The purpose of this study is to evaluate the effect of mulberry leaf extract on blood~     glucose in subjects with impaired fasting glucose.~   "
127562|NCT01385852|"~     Understanding and modulating fluid parameters is an important, but often overlooked aspect~     of phacoemulsification. In a previous study we compared the impact of using high fluid~     parameters versus low fluidic parameters on real-time IOP measured during~     phacoemulsification. The investigators found that using high parameters resulted in a higher~     absolute rise in IOP as well as higher fluctuations in the IOP when compared to low~     parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber~     instability. Based on the results of this study, the investigators decided to take it~     further and study the impact of using high parameters (and thus, higher chamber instability)~     on macular edema and thickness following surgery, in an otherwise uncomplicated surgery.~      Higher fluid parameters during phacoemulsification predisposes the eye to increased macular~     thickness~   "
127612|NCT01385189|"~     This study is designed to evaluate the safety, reactogenicity, and immunogenicity of~     Na-GST-1 adsorbed to Alhydrogel® with or without two different dose concentrations of a~     novel adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.~   "
127564|NCT01385826|"~     The investigators propose to study the efficacy of adalimumab versus placebo (double-blind~     randomization on inclusion into 2 equal groups) on reduction of ocular inflammation~     quantified by laser flare photometry after two months of treatment in patients with active~     uveitis despite well conducted treatment with steroid eye drops and MTX. The primary~     objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus~     the placebo arm. Will be considered as responding patients those in whom the evaluated eye,~     2 months after inclusion, presents at least 30% reduction of inflammation on laser flare~     photometry and improvement or a stable appearance on slit lamp examination. After the second~     month, all patients wishing to continue the trial and presenting a satisfactory clinical~     state will be treated with adalimumab for a total of one year after inclusion to~     descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.~   "
127565|NCT01385813|"~     This is an investigation of inflammatory markers in women destined to develop preeclampsia.~   "
127566|NCT01385800|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune~     Grass in grass allergic subjects following challenge with with grass in an Environmental~     Exposure Unit (EEU).~   "
127567|NCT01385787|"~     This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative~     preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three~     samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral~     blood and bone marrow: 1) pre-HCT (<3 weeks prior to starting the preparative regimen), 2)~     day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT.~     For two years after transplant, the subject's follow-up data will be collected using the~     Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective~     is to determine whether there is any association between level of pre-transplant and~     post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year~     event-free-survival, and to estimate the strength of that association in terms of the~     predictive accuracy of MRD. The investigators hypothesize that measurable MRD at either time~     point will be associated with decreased 2-year event-free survival.~   "
127568|NCT01385774|"~     The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of~     two treatment strategies of Intermittent Claudication (IC) due to an iliac artery~     obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous~     Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.~      It is our hypothesis that PTA as first line treatment is more effective than SET as first~     line treatment with regard to maximum walking distance, quality of life and costs after one~     year.~   "
127569|NCT01385761|"~     The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the~     current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.~   "
127570|NCT01385748|"~     The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to~     treat chemoradiation therapy induced severe oral mucositis in patients with head and neck~     cancer.~   "
127571|NCT01385735|"~     The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct~     therapy to levodopa) on affect perception and emotional expressiveness in a double-blind~     placebo-controlled study.~   "
127572|NCT01385722|"~     A research study to learn about the biologic features of cancer development, growth, and~     spread. We are studying components of blood, tumor tissue, normal tissue, and other fluids,~     such as urine, cerebrospinal fluid, abdominal or chest fluid in patients with cancer. Our~     analyses of blood, tissue, and/or fluids may lead to improved diagnosis and treatment of~     cancer by the identification of markers that predict clinical outcome, markers that predict~     response to specific therapies, and the identification of targets for new therapies.~   "
127573|NCT01385709|"~     The aim of this study is to determine whether blood levels of lithium or sertraline are~     affected by different phases of the menstrual cycle and whether there is an effect on~     psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase~     and one visit during the follicular phase of the menstrual cycle. On each visit, they will~     fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood~     sample will be drawn to measure progesterone level and either a lithium or sertraline level,~     depending on which medication the patient takes. The primary hypothesis in this study is~     that blood levels of lithium and sertraline will be significantly lower in women during the~     luteal phase of the menstrual cycle than during the follicular phase. Examination will also~     be made of whether symptoms will increase in severity during the luteal phase as compared to~     the follicular phase. The investigators expect a negative linear association between symptom~     severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium~     or sertraline decrease.~   "
127574|NCT01385696|"~     Preference study: Genuair vs HandiHaler inhalers in COPD patients.~   "
127585|NCT01385553|"~     Social service systems rarely acknowledge the status of men as fathers in the~     conceptualization and delivery of treatment for substance abuse or domestic violence.~     Although there has been extensive focus on the treatment of mothers who abuse substances,~     are victims of intimate partner violence (IPV) (defined as physical aggression and/or~     psychological abuse and control at the hands of an intimate partner), or maltreat their~     children there has been little consideration of the need for interventions for fathers with~     histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8~     million children are witness to violence in their homes each year. National and regional~     samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance~     abuse have children under the age of seven. Large percentages of these men continue to live~     with or have consistent contact with their young children despite aggression and substance~     use.~      Court mandated treatments for perpetrators of domestic violence have become the norm,~     however the efficacy of these treatments is questionable and most do not speak to the~     broader needs of batterers and their families. How batterer's treatments might impact~     parenting and father-child relationships and the psychosocial functioning of children is~     vastly understudied and not currently understood. Since batterer treatments are court~     mandated and require tremendous financial and community resources, the efficacy of these~     interventions in stopping the cycle of domestic violence and improving the health and~     well-being of the batterer, his partner and children is crucial. There are currently NO~     evidence-based treatments that address co-morbid substance abuse and domestic violence~     perpetration with emphasis on paternal parenting and the father-child relationship.~     Consequently, the proposed psychotherapy development project will develop and evaluate the~     potential efficacy of a novel, relational parent intervention for fathers with co-morbid~     substance abuse and IPV who have young children. The goals of this intervention are to~     decrease aggression and substance abuse by increasing focus on fathering and an improved~     father-child relationship.~   "
127575|NCT01385683|"~     Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous~     thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at~     least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation~     and the treatment of venous thromboembolism. It is administered with fixed dose and does not~     require laboratory monitoring because of the low inter and intra individual pharmacokinetic~     (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is~     very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic~     polymorphism. The inhibition of this protein can cause a significant increase in intestinal~     absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major~     drug interactions have been identified : quinidine (cons-indication) and amiodarone~     (precautions). It is likely that other interactions exist and can be clinically significant~     in patients not selected such as testing. The development of tools to study the influence of~     P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic~     polymorphism, the study of the latter is an important element in the detection of drug~     interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to~     evaluate the primary mechanism of drug interaction of dabigatran and optimize the~     experimental design of studies to be conducted.~   "
127576|NCT01385670|"~     The objective of this study is to determine the safety, performance, and effectiveness of~     the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients~     who are amenable to percutaneous closure of their PFO defects.~   "
127577|NCT01385657|"~     The purpose of this study is to assess the safety and tolerability of repeated subcutaneous~     (SC) doses of REGN668 in patients with moderate-to-severe atopic dermatitis (AD).~   "
127578|NCT01385644|"~     The primary objective of this study is to establish the feasibility and safety of infusions~     of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA~     mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF).~      The secondary objectives are to document changes in lung function, 6 minute walk distance~     (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month~     evaluation period.~   "
127579|NCT01385631|"~     The purpose of the study is to examine the effect of the cholesterol lowering agent~     Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with~     acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.~      An area with arteriosclerosis not demanding intervention in a coronary vessel other than the~     infarct related is used as measuring point and is examined at time of the infarction and~     after 12 month using intravascular ultrasound and optical coherence tomography. At the same~     time the same techniques are used to examine the implanted stent.~   "
127580|NCT01385618|"~     Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating~     hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role~     in maturation and fertilization of oocytes. Furthermore it is involved in development of~     secondary female sexual organs, fertility and maintenance of pregnancy.~      Estradiol influences these processes by binding to estradiol receptors (ER). They are~     ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which~     are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are~     expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several~     polymorphisms and mutations are known which can be linked to breast cancer, spontaneous~     abortions, osteoporosis and the point in time of menarche. Furthermore some studies have~     shown a relationship between certain polymorphisms and the risk of infertility associated~     gynecological malfunctions and the result of IVF treatments.~      Progesterone is a hormone which plays a crucial role in initiation and maintenance of~     pregnancy. It induces the transformation of the endometrium, which facilitates the~     implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by~     binding to its receptor. The gene for this receptor is polymorph within the population,~     whereas some variants seem to account for implantation failure of embryos.~      In the investigators study the investigators will analyse the role of ERP and PRP~     polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms~     of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone~     receptor gene a single nucleotide exchange at position +331 (G->A) plays a role.~      The parameters correlated with are concentrations of estradiol, progesterone and FSH, number~     of follicles, number of fertilized oocytes and pregnancy rate.~      The investigators hope to optimize established treatment protocols and to improve the~     chances of success of IVF treatments depending on the genotype of the patient.~   "
127581|NCT01385605|"~     Environmental pollutants might be jointly responsible for increase of infertility among~     women. Especially endocrin active substances seem to be of particular importance. These~     substances are chemicals which interfere with the physiological system of humans and~     animals. They have a negative impact on the endocrine system and disturb the functions of~     organs whose hormones regulate the male and female reproductive system.~      It is known that exposition to these chemicals lead to subfertility, infertility, raised~     abortions, birth defects and ovarian malfunction.~      Additionally it was shown that human embryos have a decreased cleavage rate after IVF when~     developing from oocytes with elevated concentrations of environmental pollutants.~      In this study the main focus concentrates on Nonylphenols (NP). Follicular fluids of women~     with subfertility will be analyzed by a newly developed principle including HPLC and~     NMR-Spectroscopy. This enables quantitative and qualitative analysis of enantiomers of NP.~      The results will allow risk estimations for several endocrine active substances, especially~     NP.~      Additionally conclusions concerning the correlation between thes substances and subfertility~     can be drawn.~   "
127582|NCT01385592|"~     This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's~     Disease L-dopa Induced Dyskinesias (PD-LID)~   "
127583|NCT01385579|"~     The purpose of this study is to determine if the direct mailing of fecal occult blood~     testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective~     way to improve colorectal cancer screening rates within a low income and racially/ethnically~     diverse population.~   "
127584|NCT01385566|"~     This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both~     intradermally and subcutaneously at various doses.~   "
127586|NCT01385540|"~     This will be an experimental task-based functional MRI pilot study involving the~     neuroimaging assessment of patients with severely bothersome tinnitus, defined by a global~     bothersome scale. The investigators plan to enroll a total of 12 participants (6 severely~     bothered tinnitus and 6 age-matched non-tinnitus controls) over the course of six months to~     undergo task-based imaging. Subjects in the tinnitus group may have previously participated~     in the CTRWU study (HRPO: 07-0689) conducted by Dr. Jay Piccirillo at Washington University~     and have given permission to be contacted for consideration in future studies. The selected~     paradigm will allow us to advance knowledge about the role of the attention, control, and~     other cortical networks in the development and maintenance of bothersome tinnitus.~   "
127588|NCT01385514|"~     The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin~     and soft tissue infections in soldiers during infantry training.~      This study will be conducted on three different bases among groups of male recruits to IDF~     training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two~     time points: 1. before mixing and training in confined settings, reflecting carriage~     acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for~     skin infection until the end of the training program.~   "
127589|NCT01385501|"~     This research project will develop an educational intervention to improve immunization~     acceptance by vaccine hesitant parents. This is prospective interventional case-control~     trial, where the investigators will provide the intervention in the clinical setting.~     Enrollees will be screened and selected if they meet criteria for vaccine hesitancy. The~     investigators will conduct follow up surveys following the intervention to assess change in~     attitude and follow immunization rates through 18 month well visit.~   "
127590|NCT01385488|"~     -  Breast cancer treatment-related lymphedema requires life-long self-care is required.~        -  No objective measurement mechanism exists that can easily be used to self-monitor arm~          volume.~        -  Bioelectrical impedance devices approved for lymphedema measurement may be able to be~          used for self-monitoring.~        -  The investigators will conduct a two-part study to first develop an impedance driven~          self-measurement protocal and then test the protocol in home settings.~        -  The investigators hypothesize in part two of the study that when compared to~          participants who are not self-monitoring, those who self-monitor limb volume will: 1)~          report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less~          distressful, less intense symptoms, better productivity/activity, report higher~          perceived self-management/self-efficacy and QOL; experience fewer missed days of work,~          lymphedema treatment days, arm infections, and have a smaller number of antibiotic~          prescriptions.~   "
127591|NCT01385475|"~     The primary purpose of this study is to examine the effectiveness of the current resistance~     training guidelines for older adults proposed by ACSM/AHA to improve physical function in~     individuals with reduced physical abilities. A randomized controlled intervention trial will~     be used to compare change in physical function pre- and post-intervention between a~     treatment group receiving the minimum recommendations of the guidelines and a control group~     asked not to change their physical activity participation. To better understand the clinical~     significance of such an occurrence, a secondary purpose was to determine if older adults~     with reduced physical abilities who adhere to the recommended intervention dosage will~     experience a change such that they can be reclassified to a more favorable level of~     functioning. It is hypothesized that the minimum recommended dosage of the guidelines would~     be sufficient to both improve physical function and improve functional classification in~     older adults with reduced physical abilities.~   "
127592|NCT01385449|"~     The primary hypothesis is that those patients who choose an interscalene catheter will have~     less pain postoperatively than those with single injection blocks. Secondary hypotheses~     examine physical therapy outcomes and incidence of parasthesia or pain following surgery for~     up to 3 months.~   "
127593|NCT01385436|"~     Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development~     of cervical cancer. There is a vaccine available to prevent cervical lesions associated with~     high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in~     obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination~     distribution of HPV genotypes in women with high grade cervical squamous intraepithelial~     lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is~     the most frequently found genotype but the distribution of other HPV genotypes is~     heterogeneous and includes genotypes currently not covered by vaccination.~   "
127594|NCT01385423|"~     This is a single center, modified standard design dose escalation study designed to~     determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous~     Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day~     +14 when given after haploidentical donor NK cells in patients with relapse or refractory~     acute myelogenous leukemia (AML).~   "
127595|NCT01385410|"~     This behavioural support intervention trial will investigate the potential to increase~     exclusive breastfeeding rates in an urban Kenyan community through peer mother support~     delivered either by cell phone or through group meetings. It will follow a cohort of more~     than 800 women attending antenatal care at a large public hospital, and compare indicators~     of breastfeeding and infant and maternal health between groups receiving one or other type~     of peer mother support. The main part of the study will test the primary hypothesis that~     peer group and cell phone based support can both increase rates of EBF at 3 months by 20%~     relative to a control group.~   "
127596|NCT01385397|"~     Obesity is an important public health problem that is taking epidemic proportions worldwide.~     Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the~     last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of~     the health system's budget. Also, obesity is linked with multiple co-morbidities;~     furthermore, modest weight loss has significant impact on type 2 diabetes, blood pressure~     and even reduces mortality. The investigators group has implemented an interdisciplinary~     team that has demonstrated its effectiveness for obesity management. However, the majority~     of obese subjects should be treated by primary care physicians (PCPs) that often feel~     uncomfortable when faced with the management of obesity. The investigators have therefore~     developed a clinical preceptorship for PCPs; this continuing medical education (CME)~     activity aims at engaging PCPs in obesity/overweight management. The current research~     proposal is aimed at the development and implementation of an innovative, integrated,~     interdisciplinary obesity care management system involving both primary and secondary health~     care professionals.~      The investigators hypothesize that CME based on preceptorships in combination with~     electronic tools (web site and virtual community), networking primary care (FMGs) and~     secondary care health professionals, will increase the knowledge, modify attitudes and~     perceptions of health care professionals and increase their sense of self-efficacy.~     Furthermore, this intervention should modify health care organization regarding obesity~     management and eventually improve accessibility to optimal obesity care.~      The investigators will use both action (objectives 1-2) and evaluative (objectives 3-5)~     research in order to attain specific objectives: 1) Develop and implement a~     preceptorship-based CME complemented by a web site for physicians and nurses working in~     Family Medicine Groups (FMGs). This CME will be based on needs assessment and will be~     validated by one FMG using questionnaires and semi structured interviews. Also, references~     and teaching tools will be available for participants on the web site. 2) Establish a~     collaborative intra/inter-regional interdisciplinary network to enable on-going expertise~     update and networking for FMG teams. This tool consists of a discussion forum including~     exchanges about difficult cases and a monthly virtual meeting of all participants. 3)~     Evaluate the implementation of this integrated system at the level of the ability to form a~     number of 8 FMGs/year, access and utilization of the electronic tools and participants'~     satisfaction (physicians, nurses and experts). This will be measured with the help of~     questionnaires and web logging tools. Questionnaires and group interviews will also be~     performed in order to evaluate participants' satisfaction. 4) Determine the impact for the~     participants at the level of knowledge and expertise, attitudes and perceptions, and~     self-efficacy regarding the management of obesity. Questionnaires and interviews will be~     used to this purpose. 5) Deliver transferable knowledge for health professionals and~     decision-makers. Strategies and pitfalls of setting up this program will be identified,~     performance indicators series will be developed and accessibility to care will be evaluated~     for each FMG and the 2nd line team. A knowledge transfer plan will be elaborated and~     applied.~   "
127597|NCT01385384|"~     Permanent dependency of breathing apparatus due to spinal cord injury is traditionally~     treated with different types of mechanical ventilation. However, the electric ventilation~     became a possibility through their most current versions, such as diaphragmatic pacemakers.~      Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of~     the respiratory center that doesn't works well or is inaccessible. However, this modality~     has the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for~     the development of diaphragmatic pacemaker freeing the patient from the ventilator.~      By using the mechanical energy of the diaphragm of the patient, the patient may come not~     need the ventilator tubing, tracheostomy, and with the help of their caregivers, the~     inconvenient mechanical ventilators.~   "
127598|NCT01385371|"~     This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243)~     versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms.~     Participants will receive either the sublingual grass tablet or a placebo tablet during the~     study. It is expected that those participants receiving the active sublingual grass tablet~     will have less hayfever symptoms and need less medications to treat hayfever symptoms during~     the grass pollen season.~   "
127613|NCT01385176|"~     The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve~     stimulation in heart failure patients with a New York Heart Association Class III, an~     ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less~     than 130 ms.~   "
127599|NCT01385358|"~     Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant~     morbidity and mortality, posing an increasing public health burden. Restoration of sinus~     rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with~     anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter~     ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions'~     to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions~     are made in the atria to restore SR. Long term results from this traditional surgical~     approach are excellent however as it is technically difficult open-heart procedure with~     significant morbidity and mortality, it is seldom used.~      CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal~     (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a~     more persistent or permanent state and becomes more difficult to treat with CA. Therefore,~     the optimum approach to treat patients with symptomatic long standing persistent AF has yet~     to be determined and remains a key area of on-going research.~      New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have~     recently developed which ablate a wide area around the pulmonary veins, and may offer~     advantages over the best current strategies in CA. There are also clear advantages for~     patients with greater safety and less discomfort when compared to traditional surgical~     open-heart procedures.~      At present there is small amount of encouraging data on this thoracoscopic surgical~     technique but there is no data comparing these two modalities of treatment in persistent AF~     patients. The investigators therefore wish to prospectively investigate the safety and~     efficacy of this thoracoscopic surgical technique and compare with CA in this group of~     patients. MRI scanning will also be used to visualise the effects of ablation by analysis of~     scar formation.~      The study hypothesises that thoracoscopics surgical ablation is a~   "
127600|NCT01385345|"~     This study will test the hypothesis that 6 months of periodic high dose Vitamin D3~     replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week~     intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR~     ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in~     south Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D < 25nmol/l) and~     insulin resistance (defined as HOMA1 -IR≥ 1.93).~      The hypothesis formed suggests that insulin resistance developed in South Asians is~     explained, at least in part, by the presence of Vitamin D Deficiency (VDD). Therefore if the~     VDD is reversed/ 'normalised into target range' using Vitamin D therapy in individuals at~     risk of diabetes, then markers of insulin resistance should reduce from baseline values.~     However, current UK recommended doses of Vitamin D do not adequately replenish severe VDD,~     common in South Asians, back into the target range and therefore will not reduce insulin~     resistance markers. Therefore only higher pharmacological doses are able to replace severe~     Vitamin D deficiency adequately and improve insulin resistance markers.~   "
127601|NCT01385332|"~     The purpose of this study is to determine the efficacy and safety of two new patterns of~     controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study~     will be performed in egg donors but these new patterns will be implemented in fertility~     preservation patients.~   "
127602|NCT01385319|"~     To prospectively evaluate in a multicenter open label trial whether the use of~     zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high~     bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac~     events (MACE) including overall death, any myocardial infarction (MI) or any target vessel~     revascularization (TVR).~   "
127603|NCT01385306|"~     The objective of this feasibility research study is to gather preliminary clinical data~     regarding the safety and potential clinical benefit of noninvasive neurostimulation of the~     vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to~     asthma.~   "
127604|NCT01385293|"~     The purpose of this study is to evaluate the effects of the study drug, BKM120. The study~     drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K).~     This protein is found in normal cells and in cancer cells, but often in many cancer cells~     this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer~     but this has not been tested yet in men with prostate cancer.~   "
127605|NCT01385280|"~     RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic~     estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though~     estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some~     clinical experience indicate that it may have the opposite effect on such cells, once they~     have become resistant to estrogen deprivation. In laboratory models, there is death of the~     resistant population after estradiol treatment, followed by restoration of sensitivity of~     the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving therapeutic estradiol together with exemestane may kill more tumor cells.~      PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating~     post-menopausal patients with hormone receptor-positive metastatic breast cancer~   "
127606|NCT01385267|"~     Objectives:~      To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and~     body weight. If we find discordance in fetal lung maturity in twin gestations this will~     change current practice of sampling only one amniotic sac for evaluation of fetal lung~     maturity.~   "
127607|NCT01385254|"~     The proposed study will explore longitudinally the impact of a very low birthweight (VLBW)~     infant on mother-sibling interactions and sibling adjustment. The study will also include a~     comparison group of fullterm infants to determine which sibling adjustment problems are~     typical of having a new baby in the home and which are associated with the unique stress of~     having a VLBW infant. This study will be the initial step in identifying factors affecting~     the adjustment of siblings of VLBW infants.~   "
127608|NCT01385241|"~     The purpose of this study is to test the feasibility of a stigma reduction intervention in~     Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives~     delivered via personal Ipod Touch.~   "
127609|NCT01385228|"~     The primary purpose is to define the safety and tolerability of docetaxel/prednisone in~     combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer~     (mCRPC).~   "
127610|NCT01385215|"~     The purpose of this study is to determine the safety and effectiveness of the influenza~     vaccine when administered nasally and intra-muscular (a shot of medicine given into a~     muscle). The investigators will measure the systemic (through out the body) and mucosal~     immune responses (how your body recognizes and defends itself against bacteria) to nasally~     administered influenza vaccine, and determine if nasal immunization results in immunity~     (your body's ability to avoid infections) within multiple mucosal compartments (ocular~     (eye), oral and reproductive), in comparison with intramuscular administration and placebo~     (inactive substance given in the same form as the active drug).~   "
127614|NCT01385163|"~     The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by~     armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls~     have been raped, sexually assaulted, attacked and abducted in the Eastern Provinces~     including North and South Kivu, targeted by armed groups with unparalleled levels of~     brutality.~      Access to services in North and South Kivu—both emergency and longer term care—remains a~     major challenge. Limited services as well as the potential stigma of seeking services mean~     that many survivors have never received adequate care. Results of a preliminary study found~     many survivors have substantially reduced ability to function, including reduced ability to~     perform basic tasks and activities related to earning, self care, caring for family, and~     contributing to their communities. These survivors also describe high rates of mental health~     and social problems including mood disorders, anxiety, withdrawal, and stigmatization and~     rejection by family and community.~      While social and economic development in conflict affected areas like DRC relies on~     populations who are ready and able to work, the psychological effects of conflict may mean~     that a percentage of the population living in these low-resource areas are less able to~     engage in economic opportunities even when they are available. However, there is little data~     on the best strategy to deal with this.~      This study will be run as two parallel randomized impact evaluations to investigate the~     impacts of two different intervention programs to be implemented as part of standard~     programming of the collaborating NGO. The first study will focus on the impact of IRC's~     social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a~     wait-control sample. The VSLA impact evaluation study will be conducted in communities~     served by 9 community-based organization (CBO) partners. The second study will focus on the~     impact of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a~     wait-control sample. The CPT impact evaluation study will be conducted in communities~     serviced by NGO partners currently providing psychosocial support. As an exploratory~     investigation, the researchers will follow the CPT program with the VSLA program to look at~     the effect of receiving a mental health intervention prior to the VSLA on rates of retention~     and impact.~   "
127615|NCT01385150|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and lean more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in blood samples from patients with~     acute myeloid leukemia.~   "
127616|NCT01385137|"~     RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and~     bone pain and stiffness caused by hormone therapy in patients with breast cancer.~      PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in~     treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III~     breast cancer receiving hormone therapy.~   "
127617|NCT01385124|"~     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing~     allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence~     of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical~     sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated~     transplants. More effective prevention and treatment strategies are needed.~      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in~     animal models of various inflammatory diseases including multiple sclerosis, inflammatory~     bowel disease and rheumatoid arthritis.~      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and~     immunosuppressive effects.~      As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell~     transplantation.~   "
127618|NCT01385111|"~     This study aims to investigate a diagnostic yield and performance characteristics according~     to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)~     and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration~     (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a~     better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in~     a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform~     EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first~     applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic~     yield of the EUS centered procedure is as good as that of the EBUS centered procedure and~     the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate~     diagnostic yields and performance characteristics of each group.~   "
127619|NCT01385098|"~     As the use of bariatric surgery for treatment of extreme obesity adults continues to rise,~     clinicians must be aware of pre-existing nutritional deficiencies in overweight and obese~     patients. Nutritional deficiencies are common in patients undergoing bariatric surgery and~     these deficiencies should be detected and addressed early to avoid post-operative~     complications. To improve long-term outcomes following bariatric surgery, nutritional~     screening and prescribing appropriate supplementation to prevent nutrient deficiencies is~     needed. Vitamin D deficiency is common following bariatric surgery and has been reported to~     occur in 50-80% bariatric patients.The goal of this pilot study is to help develop nutrient~     supplementation interventions following two types of bariatric surgery: Roux-en Y gastric~     bypass and sleeve gastrectomy.~      Recently, several studies in adults have revealed an inverse relationship between body fat~     and blood 25-hydroxyvitamin D3 [25(OH)D] levels, the relevant marker of low vitamin D~     status. Although vitamin D is well known for its essential role in bone metabolism and~     calcium homeostasis, increasing evidence is linking vitamin D to obesity. This study will~     evaluate vitamin D status during post operative daily supplementation of 2,000 IU of vitamin~     D3 and 1500 mg of calcium through assessment of changes in serum 25(OH)D, parathyroid~     hormone (PTH), calcium and phosphorus at baseline, 4 weeks, and 12 weeks following surgery.~     The dietary contribution of vitamin D and calcium will be estimated by food records analyzed~     using the University of Minnesota 2010 Nutrition Data System for Research (NDSR) program.~      Primary Hypothesis: Daily supplementation with 2,000 IU of vitamin D3 for 12 weeks will~     significantly increase mean serum 25(OH)D levels in obese subjects following bariatric~     surgery compared to baseline levels.~      Secondary Hypothesis: The percent response above baseline to daily supplementation with~     2,000 IU of vitamin D3 will significantly differ between Roux-en Y and sleeve gastrectomy~     patients.~   "
127620|NCT01385085|"~     Three types of workers exposed to different levels of natural sunlight will be tested for~     Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.~      In addition, each tested worker will be asked to fill a questionnaire for demographic,~     medical and personal habit information.~   "
127621|NCT01385072|"~     Patients with active acute leukemia have dismal prognoses even with allogeneic~     transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse~     rates are needed.~      Relapse risk after double umbilical cord transplantations have been shown to be~     significantly lower compared to matched sibling and matched unrelated donor transplantations~     due to better graft versus leukemia effect.~      The investigators hypothesize, that concomitant transplantation from 2 matched siblings may~     improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and~     other high risk hematological malignancies.~   "
127622|NCT01385059|"~     This randomized phase II trial studies how well axitinib works in treating patients with~     high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery~     may make the tumor smaller and reduce the amount of normal cells that have to be removed~   "
127681|NCT01384292|"~     The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment~     of opioid-induced constipation (OIC) in patients with cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~      The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week~     extension with active treatment (part B).~   "
127623|NCT01385046|"~     Project FIT is a collaboration between the public school system, local health systems,~     physicians, neighborhood associations, businesses, faith-based leaders, community agencies~     and university researchers to develop a multi-faceted approach to promote physical activity~     and healthy eating toward the general goal of preventing and reducing childhood obesity~     among children in Grand Rapids, MI, USA. There are four overall components to Project FIT:~     school, community, social marketing, and school staff wellness - all that focus on: 1)~     increasing access to safe and affordable physical activity and nutrition education~     opportunities in the schools and surrounding neighborhoods; 2) improving the affordability~     and availability of nutritious food in the neighborhoods surrounding the schools; 3)~     improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and~     physical activity among school staff, parents and students; 4) impacting the 'culture' of~     the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue~     among all community partners to leverage existing programs and introduce new ones.~   "
127624|NCT01385033|"~     The purpose of this study is to evaluate radiolabeled [18F]MK-3328 as a PET tracer for~     estimating the regional distribution and extent of amyloid plaques in participants suffering~     from amnestic mild cognitive impairment (aMCI) and Alzheimer's Disease (AD) versus healthy~     young and elderly participants. The study hypotheses will test whether [18F]MK-3328 can~     discriminate between AD participants and cognitively normal elderly control participants as~     measured by brain regional tracer uptake.~   "
127625|NCT01385020|"~     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a~     significant cholesterol lowering effect which might be caused by addictive and/or~     synergistic effects of lovastatin (monacolin K) with other monacolins and substances in~     capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is~     one capsule twice/day.~      Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides~     and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed~     lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although~     the combination of a fibrate and a statin is highly effective,concerns about an increased~     incidence of myopathy and even rhabdomyolysis have limited the widespread use of such~     combinations. Such combination therapies are prone to drug-drug interactions, which can lead~     to altered pharmacokinetic profiles of either drug, an effect observed for many statins in~     combination with fibrates. However, the drug-drug interactions have not been reported~     between red yeast rice capsule and gemfibrozil.~      The objective of the study is to evaluate the effect of gemfibrozil on the plasma~     concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice~     capsule in healthy volunteers. In addition, the investigators also measure the plasma~     concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.~   "
127626|NCT01385007|"~     Aggression, a common symptom in persons with dementia, is linked with multiple treatable~     etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain,~     the main predictor of aggression, is a common symptom that is inadequately assessed and~     treated in persons with dementia. The main treatment for aggression is antipsychotic~     medications that are ineffective, costly, and possess considerable adverse side effects.~     There is a need to test psychosocial interventions that address treatable causes of~     aggression. Preliminary data suggest the potential utility of Preventing Aggression in~     Veterans with Dementia (PAVeD), an evidence-based psychoeducational intervention aimed to~     prevent aggression, with urban dwelling Veterans. PAVeD, an in-home intervention that~     requires significant clinician time and expense has yet to be evaluated in a rural culture~     with Veterans who are in poorer health compared to urban Veterans.~      The purpose of this intervention demonstration pilot study is to pilot test and evaluate the~     PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their~     caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate.~     Clinical activities directed toward caregivers are supported by policies and procedures set~     forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to~     collect data using semi-structured interviews and standardized data collection measures~     suitable for persons with dementia and their caregivers. The interviews go beyond an~     evaluation of the outcomes by exploring how the intervention was experienced by the dyad.~      The specific aims of the study are to:~        1. Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number~          of dyads recruited and completing the study) by rural Veterans and their caregivers.~        2. Describe the preliminary outcomes (aggression, depression, Veteran/caregiver~          relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6~          months.~        3. Understand the cultural beliefs and practices of this population and the impact of the~          intervention.~      The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating~     aggression with antipsychotic medications. This study is consistent with the goals of the~     South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve~     evidence-based practices in rural Veterans and their caregivers. The next step in this~     program of research is to submit a Health Services Research and Development Service (HSR&D)~     application for pilot funding to further develop and test the telephone-based intervention~     and an appropriate control condition.~   "
127627|NCT01384994|"~     Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the~     course of their disease. In 30-40% of patients metastasis is confined to the liver. In these~     patients R0-resection of metastases may contribute to marked improvement of overall~     survival. Primary resection of liver metastasis is possible in about 15-20% of patients~     (Scheele 2005, Petrelli 2005). Recent studies indicate that perioperative chemotherapy may~     improve survival after resection of liver metastases (Portier 2007, Nordlinger 2007).~     Nevertheless, there is evidence that 70-80% of patients have recurrent disease after~     resection of liver metastasis. Stratification for the risk of recurrence may be performed~     using the FONG-score (Fong 1999).~      This study is designed to investigate the efficacy of postoperative chemotherapy combined~     with an anti-EGFR treatment using panitumumab.~      The majority of patients present to the surgeon after chemotherapeutic pretreatment with~     various not necessarily standardized regimens. Also postoperative therapy after resection of~     liver metastasis is not a clearly defined standard of care in Germany.~      Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for~     postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected~     as the chemotherapy backbone for additive treatment (Allegra 2010).~      Also, there is evidence that the combination of FOLFOX with panitumumab is associated with~     enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm~     will therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal~     cancer monoclonal antibodies directed against the EGFR are not active in KRAS mutant~     patients, the experimental arm including panitumumab will only be performed in KRAS~     wild-type patients (Amado 2008).~      The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus~     panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type~     patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are~     verified by a randomised control group without the antibody. (Figure 1: Study Design).~      The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or~     XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered~     eligible who did not progress during preoperative therapy.~      After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks~     will be granted.~      KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an~     experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone.~     Combination treatment will be performed for a duration of 3 months, after which patients in~     the experimental arm will receive maintenance therapy with panitumumab for further 3 months.~     In the reference arm, treatment will, however, be ended after 3 months.~   "
127628|NCT01384981|"~     The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary~     rehabilitation increases exercise capacity and quality of life more than pulmonary~     rehabilitation alone.~   "
127648|NCT01384721|"~     The study aims at pooling a large population of patients with suspected coronary artery~     disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were~     adequately stratified in the first place. Then the investigators will be able to assess the~     incremental value of CTCA in the stratification of prevalence of disease (non~     obstructive/obstructive) and prognosis of patients with suspected CAD). The added~     information to current evidence is how reliable and to what extent CTCA can define the~     actual burden of disease and cardiovascular risk.~   "
127629|NCT01384968|"~     Six days of dietary nitrate (NO3-) supplementation in the form of beetroot juice (~0.5~     L•d-1; 5.1-11.2 mmol NO3- •d-1) has been purported to reduce pulmonary oxygen uptake (VO2)~     during submaximal exercise and increase tolerance to high-intensity workloads. These results~     suggest that dietary nitrate supplementation has the potential to act as an ergogenic aid.~     Recently, we assessed submaximal oxygen uptake and 10 km time trial performance after 6 d of~     dietary nitrate supplementation in trained cyclists. We demonstrated an improvement in time~     trial performance compared to the nitrate-depleted placebo. However, the minimal dosage and~     duration of nitrate supplementation that is needed to elicit these performance effects~     remain largely unknown. Therefore, the purpose of the study is to assess performance~     capacity following an acute dose of nitrate supplementation consumed 3 h prior to the onset~     of exercise in trained cyclists. We will test the hypothesis that a single dose (140 mL; ~8~     mmol NO3-) of dietary nitrate supplementation in the form of beetroot juice, ingested 3 h~     prior to exercise will improve time trial performance in trained cyclists compared to a~     nitrate-depleted placebo.~   "
127630|NCT01384955|"~     We attempt to investigate the influence of physiotherapy and physical activity education~     applied in adolescence on physical fitness, curve progression, pulmonary function, physical~     activity and quality of life in adulthood. Quality of life assessment includes mental and~     social functioning, body image, self - esteem, depression and anxiety surveillance. The~     follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13~     years is available.~      The null hypothesis is that scoliosis specific exercise program applied in adolescence does~     not influence HRQoL and functioning in adulthood.~   "
127631|NCT01384942|"~     Given that individuals in bereavement tend to experience substantial psychological distress~     in the first two years following loss, individuals seeking psychological support will need~     appropriate services grounded in sound empirical scholarship. There is a lack of studies~     assessing bereavement groups, despite groups being one of the most common forms by which~     such services are offered. The prominent and emerging process of meaning-reconstruction in~     bereavement research is theorized to lead to better psychological adjustment and prevent~     more prolonged grief reactions. The principal objective of this study is to compare two~     types of group counseling for individuals in bereavement: A novel meaning-based bereavement~     counseling group and a conventional bereavement support group.~   "
127632|NCT01384929|"~     There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most~     of the available data comes from single centre studies. There is a dire need to have data~     from Indian ICUs to reflect the vast spectrum of critical care illness, services and~     practices. INDICAPS planned to collect data of all patients in the ICU on one particular~     day, and four such days spread throughout a one-year period were selected: the second~     Wednesday of July and October this year, i.e. July 14 and October 13, 2010 and the second~     Wednesday of January and April next year, i.e. January 12 and April 13, 2011. As many ICUs~     all over the country as possible were asked to participate. The investigators aimed to~     gather information about ICUs, patients in ICUs, the types and severity of illness,~     monitoring and therapeutic modalities used, types of infections,mortality rates, etc.~   "
127633|NCT01384916|"~     The purpose of the study is to investigate whether yoga or a health education group~     alleviate depressive symptoms for an individual with a partial response to antidepressant~     medication.~   "
127634|NCT01384903|"~     The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to~     plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative~     method in patients with Disseminated Intravascular Coagulation (DIC) associated with~     infection.~   "
127635|NCT01384890|"~     This will be a prospective longitudinal study describing clinical throughput metrics and~     patient reported quality of life outcome measures for patients undergoing Volumetric~     modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head~     and neck carcinoma at the British Columbia Cancer Agency.~        1. VMAT for the treatment of patients with HNC will provide opportunities for image-guided~          radiotherapy using CBCT online correction to reduce systematic and random error.~        2. Analysis of patient reported quality of life outcomes during VMAT, with and without~          CBCT acquisition, will be hypothesis generating.~   "
127636|NCT01384877|"~     This study's primary objective is to test the hypothesis that a single infusion of~     subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48~     hours of infusion and lasting a minimum of 7 days. Subjects will receive either lidocaine or~     placebo, followed at least 3 weeks later by the alternate agent.~   "
127637|NCT01384864|"~     The overall objective of this pilot study is to determine whether multispectral imaging~     increases the diagnostic accuracy of the current standard of high-definition white-light~     endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or~     cancer). The investigators goal is to develop a multispectral endoscopic platform that can~     be used to survey a large surface area and, potentially, serve as a 'red flag' for~     microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily~     determine the accuracy of these modalities during the endoscopic surveillance of Barrett's~     esophagus.~   "
127638|NCT01384851|"~     The purpose of this study is to determine the therapeutic effect of the chronic application~     of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition~     of environmental stress. The effect will be studied in terms of changes in tear physiology~     and the inflammatory biomarkers on the ocular surface.~   "
127639|NCT01384838|"~     This randomized trial aims to assess if a well defined subgroup of breast cancer patients~     benefit from a controlled physical activity program.~      All patients will be screened for their physical ability to complete the interventional~     exercise program. Only patients capable and willing to take part in this study and meeting~     all inclusion and exclusion criteria will be randomized.~      All patients are to receive identical counseling for ideal nutritional, life-style and~     physical activity.~      Patients randomized to Arm 2 will additionally undergo a controlled and observed program of~     physical activity for a period of 6 months. Thereafter the patients are expected to adhere~     to a comparable, unobserved exercise program at home.~   "
127682|NCT01384279|"~     The primary aim of the study is to investigate the efficacy of metformin and topiramate on~     second-generation antipsychotic-induced obesity. The secondary domain we look at is the~     adverse effects of both drugs. The investigators hypothesize that metformin and topiramate~     are effective in treating obesity induced by second-generation antipsychotics.~   "
127640|NCT01384825|"~     The presence of abnormalities in the cerebral venous circulation, defined as Chronic~     Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with~     Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological~     diseases. These reports have aroused much interest both in the scientific world and, above~     all, among the communities of patients and Associations having the aim of aiding people with~     MS and of promoting scientific research into this disease.~      In the literature published so far there is a lack of verification in large samples of the~     prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with~     other diseases of the nervous system.~      This is an observational study investigating the prevalence of CCSVI in subjects with MS and~     comparing it with the prevalence observed in a control population consisting of Healthy~     Controls (HC) and in a population affected by other neurological diseases of the central~     nervous system of degenerative, vascular, inflammatory and autoimmune origin.~      A total of at least 1,200 adults with MS will be included in the study, as well as 400~     healthy subjects and 400 subjects with other neurodegenerative diseases.~   "
127641|NCT01384812|"~     The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation~     of brain vessels in migraine patients without aura.~   "
127642|NCT01384799|"~     This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin~     and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a~     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human~     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is~     designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101~     when administered in combination with concurrent cisplatin and radiation over an 8-week~     treatment course, consisting of a one week run-in period of CUDC-101 administered alone,~     followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation~     therapy.~   "
127643|NCT01384786|"~     Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan~     before they are treated with radioiodine for their thyroid disease. Because the~     investigators do not get a histologically/final diagnosis the investigators want to make~     sure, that the patients treated do not have a thyroid cancer when treated.~      The investigators have found that thyroid cancer is not overlooked.~   "
127644|NCT01384773|"~     Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and~     post surgical ectasia is an iatrogenic condition. These diseases are characterized by~     weakening of the front part of the eye that causes thinning and distortion. This distortion~     results in unevenness of the cornea and produces progressive near-sightedness and~     irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to~     give enough vision, the the investigators use rigid contact lenses to create an artificial~     front eye surface. This improves visual acuity in many patients although they eventually~     fail either because they cannot be tolerated or the surface irregularity has become so~     severe that they are rejected. At this stage there is usually thinning and loss of clarity~     of the eye.~      There has been no treatment for this other than corneal transplantation, a complex surgical~     procedure with a significant complication rate and a delay in visual recovery. The treatment~     the investigators wish to perform strengthens the front of the eye by a chemical reaction~     using light and riboflavin. This technique has been studied over a decade and is widely used~     throughout the world. The FDA approved multicenter American clinical study is being analyzed~     in anticipation of its submission to the FDA for PreMarket approval. Because this is a~     progressive condition, the investigators wish to be able to offer this on a limited basis to~     patients in need with vision loss.~      Any treatment that can delay or prevent corneal transplantation is of great benefit. The~     investigators believe the evidence is compelling that this treatment is the sole alternative~     to surgical transplantation.~   "
127645|NCT01384760|"~     Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB)~     characterized by repetitive episodes of cessation of breathing during sleep due to upper~     airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired~     cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal~     and fatal cardiovascular consequences including sudden death, in addition to an increased~     risk of road traffic accidents. Continuous positive airway pressure (CPAP) is considered as~     the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of~     sleep disordered breathing and leads to symptomatic improvement especially in mild to~     moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients~     and it is not a curative treatment of OSA. It has to be used in every night on a regular~     basis. Weight reduction has always been advocated in patients with OSA who are overweight~     and may lead to improvement in the severity of OSA. The existing studies about weight loss~     are limited by small sample size, short duration (<6 months), focus on very low calorie diet~     program or surgically induced weight loss program only. However, none of them have applied~     lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior~     change. Therefore, the investigators plan to conduct a randomized controlled trial among~     Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle~     advice alone on the improvement of OSA symptoms.~   "
127646|NCT01384747|"~     -  Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to~          control group in deferred coronary lesions.~        -  Fimasartan will be more beneficial in reducing total plaque volume compared to control~          group in deferred coronary lesions.~        -  Fimasartan will be more beneficial in reducing functional impairment of stenotic~          lesions (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.~   "
127647|NCT01384734|"~     The purpose of this study is to assess the safety, efficacy, tolerability and~     pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil~     Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well~     tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1~     infected subjects.~   "
127668|NCT01384461|"~     This observational study will evaluate the safety, tolerability and efficacy of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate~     to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated~     on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate~     (weekly dose at the discretion of the physician).~   "
127649|NCT01384708|"~     The overall objective of this study is to determine whether high-resolution imaging of the~     esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and~     discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME)~     was developed by our collaborators at Rice University and provides > 1000x magnified images~     of the esophageal mucosa. The purpose of this study is to determine whether this device can~     be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell~     cancer of the esophagus.~   "
127650|NCT01384695|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic~     (precancerous) areas. This is an exploratory study of a confocal endoscope designed to~     evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of~     subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope~     provides real-time in vivo microscopic images of the mucosa which resemble standard~     pathology.~   "
127651|NCT01384682|"~     MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients~     who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will~     be randomized (1:2:2) to one of three treatment groups: to continue their current treatment~     regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily~     with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic~     assessment of tropism cannot be used to determine tropism, instead we will employ the~     genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim~     of this study is to investigate whether switching to maraviroc, in combination with either~     RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI~     with PI/r. The other aim is to see if switching to these combinations with maraviroc will~     improve some of the side effects that can be seen when people take combination therapy~     including RTI and PI/r.~      The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200~     copies/mL) patients with no history of prior virological failure, a switch to either MVC~     dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC~     dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of~     the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior)~     antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.~   "
127652|NCT01384669|"~     In this study, the investigators look at the genetic expressional alteration which~     influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.~   "
127653|NCT01384656|"~     Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably~     experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium~     (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to~     evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients~     undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group.~     The trial is double-blind and conducted at a single center.~   "
127654|NCT01384643|"~     Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting~     patient outcome following cardiovascular surgeries. Propofol, an intravenously administered~     anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to~     investigate the ability of propofol to protect kidneys against I/R injury in the patients~     undergoing valvular heart surgery.~   "
127655|NCT01384630|"~     This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in~     subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of~     RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42~     for a total of 3 injections. Study drug will be administered under close observation in a~     facility equipped to handle medical emergencies. Subjects will not be discharged from the~     facility until at least 1 hour following the end of the injection or 1 hour after their~     vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial~     measurements of vital signs, clinical laboratory assessments, and the recording of adverse~     clinical events.~   "
127656|NCT01384617|"~     The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases~     pancreatic fistula following distal pancreatectomy, compared with stapling closure of the~     pancreatic stump.~   "
127657|NCT01384604|"~     The overall goal of this project is to identify intermediate phenotypes for psychosis across~     the schizophrenia and bipolar disorders boundary with implications for future genetic~     studies. Recent studies provide considerable evidence that schizophrenia and psychotic~     bipolar disorder may share overlapping etiologic determinants. Identifying disease-related~     genetic effects is a major focus in schizophrenia and bipolar research, with enormous~     implications for diagnosis and treatment for these two disorders. Efforts have been~     multifaceted, with the ultimate goal of describing causal paths from specific genetic~     variants, to changes in neuronal functioning, to altered brain anatomy, to behavioral and~     functional impairments. Parallel efforts have identified and refined several alternative~     endophenotypes that are stable, heritable, have (partly) known biological substrates, and~     are associated with psychosis liability. Although many such endophenotypes have been~     individually studied in schizophrenia, and to a lesser extent in bipolar disorder, no study~     has comprehensively assessed a broad panel of these markers in the two disorders with~     parallel recruitment, and the extent to which they mark independent aspects of psychosis~     risk, or their overlap in the two disorders. In this research project, we will examine a~     broad panel of putative endophenotypes in affected individuals and their first degree,~     biological relatives in order to: 1) characterize the degree of familial phenotypic overlap~     between schizophrenia and psychotic bipolar disorders; 2) identify patterns of~     endophenotypes unique to the two disorders; and, 3) contrast the heritability of~     endophenotypes across the disorders. We will obtain measures of neurophysiology (e.g., eye~     tracking, P50 gating, PPI, and P300), neurocognition (e.g., attention/vigilance, episodic~     and working memory), and brain structure (e.g., volumes of gray and white matter in~     specified brain regions). Blood samples will also be collected and stored for formal DNA~     linkage analyses using the independent phenotypes identified above. All volunteers will also~     be given the option to donate dermal biopsies for future research studies.~      Establishing similarities and differences in the endophenotypic signatures within~     schizophrenia and bipolar families will provide important insights for future genetic~     studies, and clarify concepts about common and distinct aspects of pathophysiology,~     potentially meaningful heterogeneity with disorders, and the clinical boundaries of the two~     most common psychotic disorders in adult psychiatry. This line of investigation will~     potentially impact our conceptualization of psychotic disorders, help us make critical~     strides to identify the pathophysiology of psychosis, and guide development of new specific~     treatments targeting particular deficits.~   "
127669|NCT01384448|"~     The purpose of this study is to determine whether stress echocardiography or computed~     tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to~     select appropriate candidates for hospitalization and further work-up.~   "
127670|NCT01384435|"~     The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to~     placebo in patients with Spinocerebellar Degeneration (SCD).~   "
127658|NCT01384591|"~     The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and~     impaired capacity for building of muscles. In aging populations, this decreased ability to~     build muscles may represent a tipping point in the progression towards chronic physical~     frailty and disability. The goal is to examine whether novel pharmacologic therapies can~     improve nutritive blood flow to the muscles and muscle building in the elderly.~      The purpose of this study is 1) to determine if losartan administration will enhance the~     building of muscles via proteins and suppress muscle breakdown 2) to determine if~     N-acetylcysteine (NAC) will enhance blood flow to muscles and the building of muscles via~     proteins.~      The investigators will study community dwelling, healthy older men and women (60-85 years).~     Subjects will be randomized to one of three groups:~      Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental~     Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3:~     N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo~      Subjects will admit the night before and get their first dose of NAC/ losartan/ placebo with~     dinner. Subjects will be fasted after 10 pm. The next morning at 6 am blood samples will be~     taken and leg blood flow (LBF) will be measured. Subjects will receive their second dose of~     NAC/ losartan/ placebo. As from 6 am every hour blood will be drawn until 1 pm. At 8am, the~     second biopsy is taken and LFB and CEU will be measured. At 11am they get their third dose~     of NAC/ losartan/ placebo together with leucine (oral) and again a muscle biopsy is taken~     and LBF is measured. Leucine is anabolic to skeletal muscle of elderly and so the~     investigators will use it to stimulate muscle building.~   "
127659|NCT01384578|"~     120 patients of biopsy proven NASH will be randomized into two groups. Cases group will~     receive combination of pentoxiphylline and Vitamin E, and control group will receive only~     Vitamin E.~   "
127660|NCT01384565|"~     Study Design~      50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I~     B)~      Investigations:~      Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver~     function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious~     etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune~     markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal~     bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs~     Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for~     spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy~     testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD~     54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells~     measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry~     Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver~     biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of~     Hepatic venous pressure gradient ( HVPG)~   "
127661|NCT01384552|"~     The objective of this study is to determine the independent and combined effects of weight~     status and the level of dietary restraint on the relationship between package unit size and~     food intake.~   "
127662|NCT01384539|"~     The purpose of this study is to determine whether nutritional (cholecalciferol) or active~     vitamin D (calcitriol)supplementation improves vascular endothelial function in patients~     with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency.~     The investigators hypothesize that the use of calcitriol supplementation will result in~     improved vascular endothelial function as compared to cholecalciferol supplementation.~   "
127663|NCT01384526|"~     Ovarian toxicity is a well-described side effect of traditional chemotherapy in~     premenopausal women receiving treatment for early stage breast cancer. However, the impact~     of long-term endocrine therapy on ovarian function is not established, and to our knowledge,~     has never been directly studied. Understanding the effects of hormone therapy on ovarian~     aging will help breast cancer patients of reproductive age make more informed and empowered~     decisions regarding their treatment. The purpose of this study is to explore the~     relationship between tamoxifen therapy and ovarian aging. Patients will be identified~     through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and~     will be evaluated based on age and menopausal status. Women who read about the study from~     clinicaltrials.gov and contact the study coordinator will also be considered for enrollment.~     The age of menopause onset will be assessed through surveys and will be compared to the~     accepted national average age of natural menopause. Biomarkers of ovarian reserve will be~     assessed in premenopausal women between ages 25-45 and will be compared to those of healthy~     age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective~     longitudinal ovarian aging (OVA) study.~   "
127664|NCT01384513|"~     The purpose of this research study is to compare the survival rates of patients with better~     risk disease undergoing hematopoietic stem cell transplant (HSCT) to the survival rates~     reported in the medical literature of similar patients undergoing reduced intensity HSCT~     from matched related donors.~   "
127665|NCT01384500|"~     Patients who are intubated (breathing tube in windpipe) are often transported by air~     ambulance. Changes in atmospheric pressure during flight may cause pressure increases in the~     air-filled cuff holding the tube in the windpipe. Studies show that more than half the~     patients had potentially harmful pressures in the cuff during flight. High pressures lead to~     complications, such as injury to the windpipe. To avoid injury, cuff pressures must be kept~     at a safe level. There are many ways to avoid unsafe cuff pressures. One is to inflate the~     cuff with sterile fluid instead of air. Fluids are not subject to changes in atmospheric~     pressure. Using fluid, instead of air, in the cuff causes less pressure increases and less~     windpipe injury. The use and safety profile of this during transport by air ambulance has~     not been studied. This study compares tracheal tube cuff pressures, filled with air or~     fluid, at routine flying altitudes during patient transports by air ambulance.~   "
127666|NCT01384487|"~     The primary objective of this clinical study is to compare the Nidek RS-3000 Optical~     Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
127667|NCT01384474|"~     This multicenter cluster-randomized trial will evaluate the impact of Crew Resource~     Management training on the occurrence of postoperative complications and the adherence to a~     surgical safety checklist, among a large sample of French surgical departments.~   "
127671|NCT01384422|"~     -  Thirty six patients suffering from active rheumatoid arthritis despite continued~          treatment with methotrexate will be evaluated for improvement of disease activity when~          taking GLPG0634 or matching placebo for 4 weeks.~        -  During the course of the study, patients will also be examined for any side effects~          that may occur, and the amount of GLPG0634 present in the blood as well as the effects~          of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be~          determined.~   "
127672|NCT01384409|"~     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using~     multi-center, non-comparative, open-label method in patients diagnosed as disseminated~     intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC~     criteria.~   "
127673|NCT01384396|"~     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using~     multi-center, non-comparative, open-label method in patients diagnosed as disseminated~     intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the~     Japanese Ministry of Health and Welfare.~   "
127674|NCT01384383|"~     This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral~     efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451~     + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in~     treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B~     CC genotype.~   "
127675|NCT01384370|"~     In both the ASC-US Study and Adjunct Study populations, the objectives are to:~        -  evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical~          disease in women with APTIMA HPV Assay positive results and~        -  evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45~          in women with APTIMA HPV Assay positive results.~   "
127676|NCT01384357|"~     The objective of the present study was to compare ultrasound (US) characteristics and~     ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA)~     in the assessment of different malignant cervical lymphadenopathies. Patients with malignant~     cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July~     to 2010 Dec were retrospectively reviewed. There are two major study groups according to the~     treatment status of the patient's population, including patients who had pathology proofed~     previous cancer and with clinically cervical lymphadenopathies after treatment. The second~     group included patients with cervical lymphaenopathies but without previous diagnosis of~     malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to~     final diagnosis were traced and recorded. Morphologic US parameters and vascular features~     were thoroughly evaluated and compared in different disease.~   "
127677|NCT01384344|"~     Cognitive and memory disorders are characterized of Alzheimer disease. In addition,~     psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents~     and play an important role in prognostic and intervention. These symptoms are noticed before~     the diagnostic of dementia, their prevalence and their intensity increase with the evolution~     of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent~     of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest,~     initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a~     decrease of cognition and behaviour to go in goal. Assessment of psychological and~     behavioural symptoms is realised principally with neuropsychiatric scales. These contribute~     to obtain particular informations about health of patient allowing by patient and caregiver~     discussions and impressions of clinician. These scales are simples but loss of subjectivity.~     An alternative of this method is the use of gerontechnology as actigraphy (system~     out-patient which records locomotive activity with the help of piezo-electrical sensor fixed~     on a bracelet) and video recording which is associated to an informatic treatment of signal~     in order event recognition.~      The aim of study is to realise an objective assessment of activities go in goal during~     experimental sequence which has well-characterized acts, using at the same time an~     actigraphic record of activity motive (system of assessment indirect of apathy fit) and a~     video records which uses an informatic event recognition system. The assessment will realise~     with participants controls (n=30) and Alzheimer disease patients with (n=20) or without~     (n=20) apathy, during well-characterized records. The final aim is to obtain a particular~     assessment of some disorders behaviours, as apathy, which is principally characterize by a~     decrease of behaviours to go in goal.~   "
127678|NCT01384331|"~     Most Implanon users experience a reduction in the frequency and volume of menstrual~     bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged~     episodes of bleeding. This is a double blind, placebo controlled, randomised study with an~     additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years,~     who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition)~     will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to~     Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a~     daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be~     enrolled into the treatment phase provided that they have met one of the World Health~     Organization criteria for prolonged or frequent bleeding Following the initial 90 day~     record, eligible women will begin designated treatment on day 1 of the next episode of~     bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of~     that bleeding/spotting episode and will continue through 90 days.~   "
127679|NCT01384318|"~     In common clinical practice, one means of ensuring an acceptable cuff pressure in~     endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25~     cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The~     purpose of this study is to validate this technique by checking the intracuff pressure using~     a manometer after the cuff is inflated using the CPAP technique.~   "
127680|NCT01384305|"~     Even though rare disorders usually have limited case numbers, they have induced huge impacts~     on patients and their families, and has heavily burdened on our society and healthcare~     system as well. Therefore, it is essential to detect the occurrence of disorders and thus~     take appropriate measures as early as possible. The preventive goal is based on~     comprehensive understanding on rare disorders, available diagnostic and therapeutic~     approaches. However, studies related to rare disorders are often impeded by limited sample~     sizes and infrequent exchange of research materials among institutes. After referring to~     foreign experiences, the investigators have noticed that a non-profit tissue bank which can~     reposit biological samples and thus provide researchers access to samples, may be a~     solution. Through sharing this public asset, the investigators believe not only quantity and~     quality of rare disorder studies will be improved, the collaboration between various~     research institutes can also be strengthened afterwards. Most important of all, those~     achievements can ultimately benefit patients, families and the whole society.~   "
127911|NCT01381302|"~     The study population will include 100 parkinsonian patients in early stage of disease, with~     total duration not exeeding 5 years.~      The patients will undergo neurologic examination and evaluation of disease severity using~     the unified PD rating scale. Subsequently a brain SPECT will be performed using~     Tc-99m-Trodat1.~   "
127683|NCT01384266|"~     Patients are routinely given steroid eye drops following cataract surgery. This study will~     compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used~     following cataract surgery. Patients will be randomly assigned to one drop or the other, and~     evaluated for inflammation and intraocular pressure as part of the comparison. The study~     Doctor will be masked as to which drop the patient receives to avoid bias.~   "
127684|NCT01384253|"~     Monoclonal antibodies can transport and deliver radioactive elements capable of releasing~     sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study~     alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path~     length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for~     metastatic diseases.~      This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab,~     its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive~     intraperitoneal cancers.~   "
127685|NCT01384240|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and~     neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope~     device which can be used during standard endoscopy to image the gastrointestinal epithelium.~     Theoretically, by visualizing superficial mucosal changes at a high-resolution and~     magnification, the investigators will be able to obtain optical images that can be used to~     guide endoscopic biopsy and polypectomy. This may foster the selective targeting of~     dysplasia/neoplasia, thereby improving diagnostic accuracy.~   "
127686|NCT01384227|"~     The overall objective of this study is to obtain data to evaluate whether high-resolution~     imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic~     (precancerous) areas. This is a pilot study of an novel technology, a miniaturized~     microscope device which can be used during upper endoscopy to image the gastrointestinal~     epithelium. This is an exploratory, not a comparative, study designed to evaluate the~     feasibility of using this instrument in Barrett's esophagus.~   "
127687|NCT01384214|"~     The purpose of this study is to evaluate swallowing efficiency in patients with cervical~     dystonia following treatment with botulinum toxin Type A.~   "
127688|NCT01384201|"~     This is a prospective randomised study investigating the use of chromoendoscopy and confocal~     laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of~     gastric cancer.~   "
127689|NCT01384188|"~     The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and~     morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal~     women.~   "
127690|NCT01384175|"~     The aim of the present study was to assess the efficacy of thoracic epidural anesthesia~     followed by postoperative epidural infusion and patient-controlled epidural analgesia with~     ropivacaine/fentanyl in off-pump coronary artery bypass grafting~   "
127691|NCT01384162|"~     This is an open label safety and tolerability continuation study of intracerebroventricular~     administration of sNN0029, containing the growth factor VEGF165, in patients with~     amyotrophic lateral sclerosis that have previously participated in study sNN0029-001. The~     intention of the study is to investigate safety and tolerability of intracerebroventricular~     administration of sNN0029 and whether it can improve motor function and prolong survival in~     patients with ALS.~   "
127692|NCT01384149|"~     The purpose of this study is to evaluate the advantages and disadvantages of external~     selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to~     traditional SLT.~   "
127693|NCT01384136|"~     The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence,~     in cases of genetic instability and secondary to stress.~      The investigators aim is to study the telomere system in cord blood and in the placenta~     immediately after the delivery in pregnancies defined as high risk pregnancies following~     sterss events such as placental insufficiency, preeclampsia, diabetes.~      The investigators intend to compare the telomere system in maternal blood to cord blood and~     to placental biopsies and to study the influence of different stressogenes on this system.~   "
127694|NCT01384123|"~     Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents~     with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In~     addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer~     factor (TLCO), a higher prevalence of clinical depression, reduced health status and~     exercise intolerance have been observed in patients with sarcoidosis.~      Reduced health status has been related to decreased pulmonary function, depressive symptoms,~     and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea,~     an insufficient heart rate response, decreased arterial oxygen tension during exercise,~     excessive and inefficient ventilation and by respiratory muscle weakness.~      In the past, exercise capacity was shown to be limited by skeletal muscle weakness in~     patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied~     by Miller et al terminated their peak exercise test due to leg complaints. Skeletal muscle~     weakness is therefore still assumed to be present in patients with sarcoidosis.~      Treatment with oral corticosteroids, clinical symptoms of depression, myositis,~     self-reported complaints of fatigue and high circulating levels of tumour necrosis factor-α~     (TNF-α) are all present in patients with sarcoidosis and can all affect skeletal muscle~     force and exercise capacity. Additionally, low levels of circulating insulin-like growth~     factor I (IGF-I), which can be induced by high levels of TNF-α, and high circulating levels~     of interleukin (IL)-6 and IL-8 (CXCL8) have been associated with skeletal muscle weakness.~     These interleukins are part of the current concept of the immunopathogenesis of~     sarcoidosis16 and may be raised in patients with stable sarcoidosis.~      Recent studies have shown that pulmonary rehabilitation program can lead to improve in the~     health status and anxiety among patients with chronic obstructive lung disease .However, no~     study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.~   "
127695|NCT01384110|"~     The primary endpoint of this trial will be to evaluate if a single administration in human~     of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce~     postprandial glycemia and insulinemia.~   "
127696|NCT01384097|"~     A systematic literature search a goal-directed haemodynamic algorithm was created. The~     hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and~     can improve clinical outcome.~   "
127697|NCT01384084|"~     The investigators have performed colposacropexy in women with uterovaginal prolapse for many~     years with satisfactory results.~      This study was designed to compare whether, in the treatment of patients with uro-genital~     prolapse and urinary incontinence, the addition of a contemporary anti-incontinence~     procedure such as mini-sling is associated with a reduction of post-operative urinary~     incontinence (correction of pre-existent urinary incontinence and prevention of masked~     urinary incontinence).~   "
127912|NCT01381289|"~     The purpose of this expanded access program is to provide VX-770 prior to its commercial~     availability to people with cystic fibrosis (CF) who have at least one copy of the~     G551D-CFTR mutation and who are in critical medical need and who are not eligible for~     participation in other Vertex-sponsored studies.~   "
127698|NCT01384071|"~     Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of~     low back pain. No studies on the real effects of these shoes on low back pain in health care~     professions have been carried out and therefore as yet there is no real evidence of their~     effectiveness. Thus the investigators assume that wearing unstable shoes over a period of~     six weeks could reduce low back pain and functional disability due to the changes of the~     gait and posture and may increase the quality of life.~      The purposes of this study are:~        1. To evaluate the modifications of pain level, functional capacity and quality of life~          among individuals with moderate level of non-specific chronic low back pain after~          wearing unstable shoes.~        2. To quantify biomechanical modifications of gait and posture.~   "
127699|NCT01384058|"~     It is of interest how ezetimibe alone or in combination with statin may influence~     atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus.~     The primary objective of this study will be whether there is a change of the concentrations~     of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.~   "
127700|NCT01384045|"~     Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive~     diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP),~     carry out a randomized-controlled trial of usual care versus an outreach intervention~     designed to increase guideline concordance with American Diabetes Association (ADA)~     recommendations for blood pressure, Low-density lipoprotein (LDL), and glycosylated~     hemoglobin (A1c) goals, referrals for retinal exams, and aspirin therapy.Primary hypotheses:~     The proportion of patients meeting goal will be 10% higher in the intervention compared with~     control group in the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood~     pressure<130 mm Hg or diastolic blood pressure<80 mm Hg.~   "
127701|NCT01384032|"~     Cardiovascular disease (CVD) is recognised as one of the main causes of death in the western~     world. LDL- cholesterol ('bad' cholesterol) and other lipids (fats) are important CVD risk~     factors. Apolipoprotein E (apoE) is an important transporter of fats in the blood. ApoE~     comes in E2, E3 and E4 forms, depending on your genetic make up. Approximately 60% of the UK~     population are E3/E3, 25% E4 carriers and 15% E2 carriers. There is some evidence to suggest~     that an E4 genotype may put you at modestly higher risk of CVD. Furthermore although very~     inconclusive previous studies have suggested that E4 individuals are slightly more sensitive~     to the LDL-cholesterol modifying effects of dietary fats (saturated fat, total fat, fish~     oil) showing slightly, greater reductions when low levels of these fat are consumed, and~     greater increases when high levels of these fat are consumed. Therefore, the aims of the~     Satgene study is to examine the impact of modifications in dietary total fat and saturated~     fat intakes, alone and in combination with fish oil supplement on LDL-cholesterol and other~     blood lipids, in individuals with an E3 and E4 genotype. The levels of total fat and~     saturated fat used in the current study are within the range observed in a typical UK~     population.~   "
127702|NCT01384019|"~     The investigators examined the mechanism underlying the lack of benefit from distal~     protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial~     Infarction (STEMI) in a prospective, randomized trial.~   "
127703|NCT01384006|"~     To expand the donor pool for pancreas allografts. For detailed description please see below.~   "
127704|NCT01383993|"~     In this study we will measure the concentration of the drug called voriconazole which is~     used to fight infections caused by fungus in children who usually are cancer patients and~     have their immune system down. Since we know the dose in adults, and we think we know the~     matching doses in the young patients ages 2 to less than 15 years old, we will compare the~     amount of drug that goes into the system with what we know works in adults. We give the drug~     by a needle directly into the blood, then few days later we stop that and give the drug by~     mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.~   "
127705|NCT01383980|"~     Surgical patients fed up until the point of surgery will have safe delivery of more calories~     compared to a group whose feeding is held at midnight prior to surgery.~   "
127706|NCT01383967|"~     This is a two part study. Part A is a multiple-ascending dose study in up to 6 different~     groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A~     will allow investigation of up to 6 different doses of LY2979165. The drug will be~     administered for a total of 14 days. Subjects will be resident in the clinical research unit~     (CRU) from Day -1 (the day before dosing) until Day 15.~      Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12~     subjects. The drug will be administered for a total of 14 days. In addition to the same~     assessments as would have been completed in Part A, subjects in Part B will also have~     cerebrospinal fluid samples taken from the lower lumbar region of their spine.~   "
127707|NCT01383954|"~     The purpose of this proposed study is to conduct a trial with knee Osteoarthritis (OA)~     patients using the diclofenac gel.~   "
127708|NCT01383941|"~     This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic~     characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17~     years, receiving one year of guidelines-based therapy for asthma and~     rhinitis/rhinosinusitis.~   "
127709|NCT01383928|"~     This will be a phase 1/2, multicenter, open-label study using the oral formulation of~     IXAZOMIB administered twice weekly in combination with lenalidomide and low-dose~     dexamethasone. Both phases of the study will include patients who have newly diagnosed~     multiple myeloma and have not previously received systemic treatment.~      Both the phase 1 and the phase 2 portions of the study will include induction therapy~     consisting of 1 year of therapy followed by maintenance therapy that will continue until~     progressive disease or unacceptable toxicity. Maintenance therapy will be IXAZOMIB alone on~     Days 1,4,8, & 11 of a 21-day cycle.~   "
127710|NCT01383915|"~     Aim: The purpose of the study is to characterize the at-risk phases preceding a first~     episode of bipolar disorder and of schizophrenia, and to identify clinical and biological~     predictors of the disease development.~      Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of~     Bipolar Disorder (BPD) or schizophrenia.~      Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will~     differentiate between individuals developing BPD and schizophrenia.~   "
127913|NCT01381276|"~     The purpose of this study is to determine the vitamin A equivalents in high-carotenoid~     varieties of cassava.~   "
127711|NCT01383902|"~     This comparative pilot study is designed to compare the rates of gastric emptying and by~     inference rates of digestion of challenge meals. Two types of meal will be compared,~     chocolate mousse style dessert and chocolate bars. The information from this study will then~     be compared to the elicitation times for both objective and subjective symptoms in the~     allergic patients who have been challenged in a different study using the same two meals.~   "
127712|NCT01383889|"~     This will be an open randomized clinical trial involving pregnant women between 35 and 37~     weeks randomized to two modalities of exercise: treadmill or stationary bike. The study~     hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in~     relation to treadmill exercise.We will study the acute effects of exercise for both the~     mother and the fetus, monitoring the parameters before, during and after exercise for 20~     minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum~     heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood~     pressure monitorization) and continuous cardiotocography and blood will be collected to~     measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and~     after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal~     heart rate, number of fetal movements, transient accelerations, decelerations, short-term~     variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total~     cholesterol and HDL.The analysis will be based on intention to treat, according to the~     recommendations of the CONSORT (2010).~   "
127713|NCT01383876|"~     Cervical collars are commonly used to provide external immobilization after elective~     Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is~     the perception and assumption that it can prevent early instrumentation failure and promote~     successful spinal fusion. However, there are a number of potential complications associated~     with cervical collars such as skin breakdown, ulceration, neck pain, impedance upon~     activities of daily living, and impaired swallowing. Considering these conflicting factors,~     there is wide disagreement among spinal surgeons about the utility, benefits, and necessity~     of collar use following elective PCLIF.~      Hypothesis: Wearing a cervical collar for 12 weeks after posterior cervical laminectomy and~     instrumented fusion will not demonstrate substantial benefits as measured by the incidence~     of instrumentation failure, rate of nonunion, or clinical outcome measures.~      Specific Aim I: To compare the outcomes of surgery in patients who will wear a cervical~     collar for 12 weeks following surgery versus those who will have the collar removed prior to~     discharge after surgery.~   "
127714|NCT01383863|"~     The purpose of the protocol is to assess the rate of castration resistance, disease~     progression and overall survival over a 3-year period post-androgen deprivation therapy~     (ADT) induction in a study cohort of patients with advanced disease.~   "
127715|NCT01383850|"~     Infants born between 28 and 32 weeks' gestation with radiological findings and clinical~     symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive~     Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either~     standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of~     life, followed by medical air until NCPAP was needed. The aim of the study was to assess the~     therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20%~     oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in~     terms of reducing the rate of mechanical ventilation (MV).~   "
127716|NCT01383837|"~     Adolescents with substance use disorders (SUD) are at substantial risk for contracting~     HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction~     interventions have been developed to meet their unique needs, and none use a family-based~     intervention approach, which the literature recommends as the focus for intervention for~     youth. Current state policies neither require providers in clinics delivering substance use~     treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for~     HIV/STI prevention. There is clear public health need to develop innovative methods of~     service delivery and effective strategies of HIV/STI sexual risk reduction that address~     multiple contexts of risk (i.e. family) for this high risk population. The current proposal~     addresses this need by developing a provider-delivered HIV sexual risk reduction~     intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics'~     capacity to help families under their care to more comfortably address the adolescent's~     sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk~     behaviors among adolescents with SUD in care.~   "
127717|NCT01383824|"~     The purpose of this study is to monitor the performance and of the Silent Hip™ in the~     treatment of patients with hip joint disease requiring a total hip replacement. Patients who~     enter the study will be evaluated at regular intervals following hip surgery using patient,~     clinical and x-ray assessments.~   "
127718|NCT01383811|"~     The objective of this study is to determine the effects of adjunct exercise in treatment~     resistant depression. The central hypothesis for the research is that adjunct exercise with~     usual care in Treatment Resistant Depression (TRD) will have significant effects in~     improving the psychiatric symptoms in comparison to usual care alone.~   "
127719|NCT01383798|"~     The specific aims of the current study were: 1) To determine the prevalence of IDNA in a~     sample of female rowers at the beginning of a training season; 2) To determine how IDNA~     affects endurance training and performance at the beginning of a training season; 3) To~     determine how iron supplementation affects iron status, training and performance in IDNA~     female collegiate rowers. The researchers hypothesized that IDNA affects endurance~     performance in female collegiate rowers both in and outside of the laboratory, and that iron~     supplementation of IDNA rowers will improve iron status, and consequently, training quality~     via increased energetic efficiency.~   "
127720|NCT01383785|"~     Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the~     thrombus occlusion is better than normal injection during primary percutaneous intervention~     (PCI) for the treatment of acute myocardial infarction. Using this modification of injection~     method the investigators can achieve less microvascular damage and a reduction of the~     infarct size with a significant improvement of the outcome at six months.~   "
127721|NCT01383772|"~     The purpose of this study is to determine the risk of failing the visual field criteria to~     hold a driving license following retinal laser treatment delivered with a multi-spot~     photocoagulator.~   "
127722|NCT01383759|"~     The goal of this clinical trial is to determine the toxicity and also the efficacy of a~     treatment that includes the following treatment: Two medications, bortezomib and~     dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged~     course of treatment with bortezomib and dexamethasone after transplantation. This type of~     treatment has been very effective in multiple myeloma. However, there is little experience~     with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD)~     or amyloidosis. The investigators and others have treated patients who have MIDD and~     amyloidosis with bortezomib and autologous stem cell transplantation and have had success~     with this treatment. But the combination of autologous transplant with BD given before and~     after the transplant is a new way of treating these diseases, which the investigators~     believe will be very effective.~   "
127723|NCT01383746|"~     Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor~     prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from~     curative surgical resection and most patients have medical treatment by palliative treatment~     by palliative chemotherapy. It is not standard first-line chemotherapy validated for~     unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are~     observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4~     months). In case of tumor progression ater this first line therapy, no treatment is~     currently being validated.~      RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90~     Yttrium microspheres.~      In the patients with unresectable CCK , the first pilot studies showed interesting results~     with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.~      Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic~     CCK in tumor progression after first-line therapy.~   "
127724|NCT01383733|"~     This multicenter, open-label, multiple ascending dose study will evaluate the safety,~     tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with~     advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640~     intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or~     unacceptable toxicity occurs.~   "
127725|NCT01383720|"~     This is a prospective, single-arm feasibility study designed to assess the acute safety and~     performance of the Lotus Valve System for transcatheter aortic valve replacement in~     symptomatic patients with calcified aortic valve stenosis and who are at high risk for~     surgical intervention.~   "
127726|NCT01383707|"~     The multicenter, open-label, single-arm, non-randomized, two-stage Simon's design, phase II~     study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in~     combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU] and oxaliplatin) in~     participants with colorectal cancer and liver metastases. Participants will receive~     combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose~     and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive~     mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants~     will undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5~     mg/kg IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative~     phase (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6),~     participants showing different alternative conditions admitted by the protocol will undergo~     different management (alternative study designs 1 to 3).~   "
127727|NCT01383694|"~     Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of~     substance P. These actions may accelerate the oropharyngeal swallow response, improving the~     swallowing of dysphagic patients.~   "
127728|NCT01383681|"~     This is a retrospective study of patients with spasticity in the Spanish population.~   "
127729|NCT01383668|"~     This phase I trial studies the side effects and best dose of sirolimus and gold sodium~     thiomalate when given together in treating patients with advanced squamous non-small cell~     lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth~   "
127730|NCT01383655|"~     In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing~     symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always~     satisfactory.~      The purpose of this trial is to investigate the effectiveness of iv-magnesium in the~     treatment of moderate or severe bronchial obstruction associated with viral infection in~     small children.~      The study population will include the children attending the Pediatric Emergency Department~     of Oulu University Hospital because of respiratory infection and bronchial obstruction that~     is not relieved with conventional treatment. After written consent from the parents, the~     children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl.~     The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours~     from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time~     points and length of hospital stay.~      The sample size is 64 children at the age of 6 months to 4 years.~      If iv-magnesium is effective in relieving viral infection associated bronchial obstruction,~     that would be an important addition to the treatment of this common disease.~   "
127741|NCT01383512|"~     Upper limb motor control after a stroke may be improved with rehabilitation robotics at a~     subacute stage. The aim of this multicenter controled randomized single blind study is to~     define the place of rehabilitation robotics at this phase of the rehabilitation process.~     Both groups will realize the same time of rehabilitation. The cost benefit ratio will be~     compared in each group through medical assessment of improvement and definition of the costs~     due to the rehabilitation process.~   "
127742|NCT01383499|"~     The aim of this trial is to select an optimum dose may be selected based on bronchodilator~     efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.~   "
127743|NCT01383486|"~     A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their~     own use based on expected duration of pain greater than 12 hours.~   "
127773|NCT01383096|"~     This study is designed to assess prototype formulations compared to the aqueous dispersion~     of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is~     hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to~     that observed when given after food. This will improve the utility of OZ439 in the field as~     well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is~     very important for an antimalarial drug product destined for use in developing counties.~   "
127731|NCT01383642|"~     Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a~     precursor to the frailty phenotype seen in the elderly population. A recent study found that~     vestibular dysfunction is common in the US population, and that the prevalence of this~     impairment increases steeply with age. However, it is unknown whether the aging process has~     global effects on the vestibular end-organ or whether specific structures, e.g. the~     semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical~     implications of specific deficits of the vestibular end-organ are unclear. As such, the aims~     of this proposed research are: 1) to evaluate whether the normative aging process is~     predominantly associated with dysfunction of the semicircular canals (as measured by caloric~     and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by VEMP~     testing); 2) to determine if there are any characteristic clinical features associated with~     the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the~     semicircular canals or of the otoliths is associated with a higher risk of frailty and~     falls. The investigators plan to pursue these aims through a cross-sectional and prospective~     cohort study of a group of individuals age 70 and above. Vestibular physiologic tests will~     be administered to all study participants, and test results will be correlated with baseline~     clinical symptoms and frailty status as well as prospective one-year fall risk. A greater~     understanding of vestibular physiologic deficits and their clinical implications in older~     individuals can inform the development of rational vestibular rehabilitation strategies that~     may more effectively mitigate the frailty phenotype and reduce fall risk.~   "
127732|NCT01383629|"~     This RCT aims to study the effect of preoperative counselling in reducing patients fear and~     visual perception during vitrectomy under local anaesthesia.~   "
127733|NCT01383616|"~     Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression~     fractures has been shown to be successful in providing acute pain relief, enabling improved~     function, and restoring of vertebral body height. However, limited prospective data exists~     in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to~     bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to~     compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon~     kyphoplasty.~   "
127734|NCT01383603|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide~     desensitising vaccine currently being developed for treatment of cat allergy.~      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at~     the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently~     exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate~     clinical development of peptide immunotherapy vaccines, in addition to providing an improved~     understanding of the underlying molecular mechanisms of efficacy, thus providing new leads~     for therapeutic intervention.~   "
127735|NCT01383590|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide~     desensitizing vaccine currently being developed for the treatment of cat allergy.~      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at~     the conclusion of therapy. The aim of this study is to identify changes in potential~     biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that~     equate with clinical efficacy.~   "
127736|NCT01383577|"~     Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy~     coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right~     anterior and right posterior) use to be ligated in order to obtain therapeutic success. It~     is commonly performed either through the ligation of a single hemorrhoid per session spaced~     by some few weeks to the second and third sessions, or of all three major hemorrhoids in one~     single session. Advocates of either method of hemorrhoidal ligation have arguments to defend~     their choice in terms of advantages, supported mainly on personal preferences. The~     investigators objective is to determine, through a controlled double-blinded randomized~     study, if there is any superiority of single hemorrhoidal ligation per session (in a total~     of three sessions) over the method of ligation of all three main hemorrhoids in a sole~     session in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity,~     patient satisfaction and costs (institutional, labor and patient-related).~   "
127737|NCT01383564|"~     Obstructive sleep apnea syndrome (OSAS) and asthma are both common disorders in Hong Kong,~     with prevalence of at least 4% among the middle-aged male Hong Kong (HK) Chinese populations~     and 7.2% in young adults respectively. OSAS is characterized by repetitive episodes of upper~     airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime~     sleepiness, impaired cognitive function and poor health status. Continuous positive airway~     pressure (CPAP) is the first line of therapy for sleep apnea. CPAP provides a pneumatic~     stent for the upper airway, eliminating the airway collapse during inspiration.~      Asthma is a chronic inflammatory disorder of airways, characterized by airway~     hyperresponsiveness that leads to recurrent episodes of wheezing, breathless, chest~     tightness, and coughing, particularly at night or in the early morning. Nocturnal asthma is~     not a different condition from asthma and is defined as a variable worsening of asthma at~     night, in which the mechanisms are not completely understood.~      The prevalence of OSAS in asthmatic patients has not yet been studied, but several studies~     have reported an increased prevalence of OSAS symptoms in asthmatic patients. OSAS and~     asthma share some common risk factors, which include obesity, gastroesophageal reflux and~     rhinitis. CPAP treatment has been shown in prospective clinical studies to have a positive~     impact on asthma outcome in patients with concomitant OSAS, for example, improvement of~     asthma related quality of life in subjects with stable mild-to-moderate asthma, but there~     was no change in the airway responsiveness or forced expiratory volume in one second.~     Although important, these studies included small numbers of participants used nonrandomized~     designs. This study is to assess the impact of CPAP treatment on asthma control among~     patients with nocturnal symptoms and moderate OSAS.~   "
127738|NCT01383551|"~     The proposed of this study is to determine if an intervention, known as the Becoming~     Parents programme, is more effective in improving the mental health, marital relationship~     and parental competence of expectant couples in a Chinese community.~   "
127739|NCT01383538|"~     The purpose of this phase I study to determine the optimal dose for the combination of~     IPI-926 plus FOLFIRINOX (5-fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin)~     chemotherapy in patients with pancreatic cancer.~   "
127740|NCT01383525|"~     The trial objectives are to establish the safety & efficacy of using the DIO-DENT 10~     DENTAL DIODE LASER SYSTEM , a TSLTP laser (790 nanometers) to perform laser trabeculoplasty~     (TSLTP) to reduce IOP in patients with open angle glaucoma. (Including Pigmentary &~     Exfoliative Glaucoma) that have poorly controlled IOP.in a Non-Contact mode~   "
127744|NCT01383473|"~     Many children with cancer cannot participate regularly in school due to frequent~     hospitalizations for treatment or treatment related effects such as pain, nausea, and~     fatigue. Prior studies have shown that children with cancer desire to attend school while~     receiving therapy despite these challenges, and that they report psychological and~     psychosocial difficulties if unable to attend. While school attendance has been found to~     correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and~     self-esteem, little is known about how children with cancer experience school attendance~     while receiving active cancer therapy. The purpose of this study will be to explore how 6-12~     year old children with cancer perceive school attendance pre and post diagnosis during~     active therapy as measured at one-time point, 6 months (± 2months) into active therapy.~   "
127745|NCT01383460|"~     50 patients of Acute-on-chronic liver failure (ACLF) will be enrolled and randomized into~     G-CSF+EPO or Placebo arms~      Treatment protocol To administer G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at~     days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with~     Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).~      Standard medical therapy included as per requirement lactulose, bowel wash, albumin,~     terlipressin, antibiotics (if indicated) will be continued and recorded. Pentoxiphylline in~     alcoholic hepatitis and Tenofovir in Hep B reactivation Controls: Standard medical therapy~     will be given along with placebo in similar prefilled syringes.~      Follow up Physical examination will be done daily, after 1 week and at 4 weeks, at 2 months,~     at 3 months and at 6 months CBC on alternate day for 1 week, at end of 1 week and then at~     end of 4 weeks , at 2 months, at 3 months and at 6 months~      KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months,~     at 3 months and at 6 months LFT along with PT/INR on alternate day for 1 week, at end of 1~     week and then at end of 4 weeks, at 2 months, at 3 months and at 6 months AFP at baseline,~     after 4 weeks, at 3 months and at 6 months Liver regenerative potential efficacy testing at~     baseline and after 4 weeks~   "
127746|NCT01383447|"~     This phase I/II trial is studying the side effects and best dose of entinostat when given~     together with imatinib mesylate and to see how well it works in treating patients with~     relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.~     Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth~   "
127747|NCT01383434|"~     Patients with severe, refractory aplastic anemia have a severe, life threatening disease in~     their bone marrow. Refractory disease means that disease has come back or not responded~     after receiving one or more immunosuppressive treatments. High dose chemotherapy followed by~     bone marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia~     but complications from Graft vs Host disease (GVHD) and graft failure have limited the~     survival for those patients.~      Another study done here at Johns Hopkins has shown that in patients with other diseases~     (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often~     patients had complications of GVHD and engraftment failure.~      This research is being done to find if this approach will help patients with aplastic anemia~     who have failed other treatments will have better outcomes.~   "
127748|NCT01383421|"~     Post-marketing observational study to determine the effectiveness and patient satisfaction~     with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization~     of a Patient Support Program (PSP).~   "
127749|NCT01383408|"~     Previous studies have shown that specially trained sniffer dogs are capable to discriminate~     breath samples of patients with lung cancer and healthy individuals. So far it is not known~     whether this differentiation is specific for lung cancer or just identifies any form of~     (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast~     cancer and ovarian cancer is tested.~   "
127750|NCT01383395|"~     To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult~     subjects.~   "
127751|NCT01383382|"~     Using individualized patient estimates of procedural risks and benefits, this project will~     transform the process of informed consent for coronary angioplasty into a dynamic~     educational tool for patients and physicians and is a direct response to the Institute of~     Medicine's call for a more evidence‐based, efficient, patient‐centered healthcare system. It~     is hypothesized that patients will develop a greater understanding of their individual risks~     and benefits from PCI, will be empowered to more actively engage in shared decision-making,~     as well as have improved awareness of their responsibility to adhere to dual anti-platelet~     therapy if treated with a drug eluting stent (risks for target vessel revascularization with~     bare metal and drug eluting stents are also provided in the new consent form). It is also~     anticipated that physicians, in turn, will use these individualized estimates to better~     discriminate between risks and benefits among different bleeding avoidance therapies so as~     to improve the safety and cost-effectiveness of PCI.~   "
127752|NCT01383369|"~     The purpose of this study is to evaluate sleep cycle before and after fast-track~     arthroplasty (3 days before and 10 days after) combined with cognitive testing~     preoperatively, on postoperative day 1,2,10.~   "
127753|NCT01383356|"~     The data from this study will be used to compare the kinetic profile of metformin 500mg in~     linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference~     product administered concomitantly with linagliptin 2.5 mg tablet.~   "
127754|NCT01383343|"~     This phase I trial studies the side effects and best dose of sorafenib tosylate when given~     together with bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil in~     treating patients with colorectal cancer that has spread to other parts of the body. Drugs~     used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Sorafenib~     tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor~     cells to grow and spread. Sorafenib tosylate and bevacizumab may also block tumor growth in~     different ways by targeting certain cells. Giving sorafenib tosylate and bevacizumab~     together with combination chemotherapy may be a better treatment for colorectal cancer.~   "
127755|NCT01383330|"~     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml,~     Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed~     condition.~   "
127756|NCT01383317|"~     Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in~     patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving~     procedure many people have a significant amount of postsurgical pain. Severe postsurgical~     pain may lead to chronic pain in some people. Remote Ischemic Preconditioning may reduce~     the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a~     balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a~     few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to~     three times. This procedure causes the body to increase its natural pain relief system that~     may help to decrease the amount of postsurgical pain.~   "
127757|NCT01383304|"~     Previous studies indicate that patients with cardiovascular disease have a variable response~     to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial~     infarction. This has given rise to the phenomenon aspirin low-responsiveness. Laboratory~     aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet~     production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether~     a low platelet response to aspirin results in an increased risk of future thrombotic events~     is of great clinical significance, but is still unknown.~      The investigators hypothesize that patients with a reduced response to aspirin, determined~     by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher~     risk of thrombosis.~      The purpose of this study is to investigate whether a higher incidence of cardiovascular~     events is found in patients with coronary artery disease (CAD) having a reduced biochemical~     response to aspirin compared with CAD patients having a normal biochemical response to~     aspirin. In addition to CAD, all patients have at least one of the following risc factors:~     previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.~   "
127758|NCT01383291|"~     -  Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be~          enrolled.~        -  Their data will be collected from the files.~        -  Comparison between two groups will be carried our: Those who underwent a posterior IVS~          and those who underwent posterior prolift procedure.~        -  The data will be obtained by questionaires by a telephone interview by a physician who~          did not participate in the surgery.~        -  Follow-up physical examination data will also be obtained.~   "
127759|NCT01383278|"~     This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single~     session, computer-directed 5 A's intervention for smoking (experimental condition) to~     screening and resource provision (control condition). Follow-up visits will occur at 1 and 3~     months post study enrollment. Measures will focus on tobacco use and related psychosocial~     outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to~     implement each intervention.~      The Investigators hypothesize that patients receiving the computer-directed intervention~     will have significantly higher tobacco abstinence rates at 3 months post study enrollment~     compared to the control group. If indeed the computerized intervention increases tobacco~     abstinence rates compared to the control group, this intervention could be used to increase~     access to treatment for the millions of US smokers, ultimately reducing tobacco mortality~     and morbidity rates in this country.~   "
127760|NCT01383265|"~     In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a~     dilute solution of Indigocarmine (IC) delivered by the water method (study method) will~     improve adenoma detection rate compared with the water method with plain water alone~     (control method).~   "
127761|NCT01383252|"~     In a prospective, randomized, controlled study, two methods (water method vs. air method) of~     performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC~     screening. The investigators hypothesize that:~        1. Study method increases overall cecal intubation with comparable assessment of current~          experience and patient willingness to repeat future colonoscopy compared with~          conventional colonoscopy~        2. Study method improves bowel preparation and increases polyp pickup rate~   "
127762|NCT01383239|"~     Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to~     increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million~     physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of~     $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair~     surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5~     years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20%~     and up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable~     variables have been associated with failure of repair, postoperative rehabilitation is a~     modifiable variable that has received little attention. The investigators propose a~     multicenter randomized controlled trial to study one important strategy for postoperative~     rehabilitation: early versus delayed onset of physical therapy. This pilot study will enroll~     patients with isolated supraspinatus tears who undergo a standard surgical repair technique.~     The investigators hypothesize that delaying the onset of physical therapy will improve~     healing and patient outcomes. Our primary outcome variable is the Western Ontario Rotator~     Cuff (WORC) Index (a disease specific validated outcome measure). Because outcome measures~     may not always correlate with healing of rotator cuff repairs 50, our secondary outcome~     measure will be healing based on MRI scans 12 months after surgery.~   "
127763|NCT01383226|"~     Patients are often referred for E(B)US examination and sampling of enlarged mediastinal~     and/or hilar lymph nodes that are not visible on a standard chest X-ray but are discovered~     by accident on CT scan performed outside the context of lung cancer or extrathoracic~     malignancies. Since CT scan is largely used and E(B)US is a minimally invasive technique,~     these cases are explored more frequently but so far nothing is known, however, on the~     prevalence of abnormal findings in EBUS sampling in this particular population and on the~     clinical implications (mainly therapeutical implications) of E(B)US findings.~   "
127764|NCT01383213|"~     The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2~     administration by a Venturi mask in terms of achievement of criteria for endotracheal~     intubation during severe acute respiratory failure caused by pneumonia~   "
127855|NCT01382030|"~     Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic~     control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide,~     ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An~     additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed~     by MRI and CT scans and FDG-PET in a subgroup of patients.~   "
127765|NCT01383200|"~     In this study the investigators will be comparing two different types of anesthetic, a~     numbing eye drop and a numbing gel, to test if they are equally effective or if one has a~     better outcome in terms of the level of comfort you experience one hour and one day after~     your surgery. The two medications are commonly used and appear to be equally effective for~     other types of eye surgery, such as cataract surgery. This study will show if one type of~     anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure,~     you will be given a short questionnaire to determine the baseline comfort of your eyes. In~     the operating room, one type of anesthetic will be put in one eye, and the other medication~     will be put in the other eye. Which anesthetic you get in each eye will be chosen in a~     random way (similar to flipping a coin). After your LASIK surgery, the investigators will~     ask you if you felt more comfort in your right eye, your left eye, or if they were equal,~     and the investigators will ask you the same survey questions that were asked prior to your~     LASIK to get more details about your experience.~      *Of note- the randomization being done is for which eye will be receiving the lidocaine and~     which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and~     tetracaine in the other eye, the randomization is for each individual eye. This means, of 11~     patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes~     received tetracaine.~      when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for~     tetracaine, giving a total of 22 eyes. This is important to note since the randomization~     refers to EYE for each individual patient, and not for the patient (ie: participant means 1~     eye, not 1 person in the descriptions below).~   "
127766|NCT01383187|"~     Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the~     face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic~     problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of~     the affected area has become the golden standard for the treatment of deep partial thickness~     and full thickness skin burns and represents the treatment of choice. Despite of all the~     progress achieved in the treatment process (artificial skin, cultured keratinocytes), the~     therapeutic results are sometimes unacceptable due to functional and cosmetic deficits~     causing severe psychological and emotional distress, particularly in the form of disfiguring~     and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement,~     peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation~     disorders. Consequently, the quality of life is markedly decreased. That is why new methods~     of burn wounds covering are intensively searched. Based upon the results of available~     pre-clinical studies, the local use of autologous platelet concentrate with their active~     growth factors appears to be a good and promising possibility how to improve faster and~     higher quality of healing deep skin burn wounds.~   "
127767|NCT01383174|"~     The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn),~     improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina~     counselors who have had breast cancer provide support to recently diagnosed women. The~     investigators call these counselors peer support counselors.~   "
127768|NCT01383161|"~     This project is designed to study the effects of the dietary supplement curcumin on~     age-related cognitive impairment. In particular, the study seeks to determine the effects of~     curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain.~     Genetic risk will also be studied as a potential predictor of cognitive decline.~      Subjects will be randomly assigned to one of two treatment groups: either a placebo or the~     curcumin supplement (465 milligrams of Theracurmin™ of which 30 mg is curcumin). The~     investigators expect the people receiving the curcumin supplement to show less evidence of~     decline and fewer after 18 months than those receiving the placebo. The investigators~     believe cognitive decline and treatment response will vary according to a genetic risk for~     Alzheimer's.~      The investigators will study 132 subjects with memory complaints aged 50-90 years.~     Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine~     genetic risk and to rule out other neurodegenerative disorders linked to memory complaints.~     Subsequently, subjects will undergo an~     -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP)PET~     scan and a baseline neuropsychological assessment to confirm MCI or normal aging diagnosis.~     Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo), and~     be asked to return every three months for regular MRIs and review sessions. Every 6 months,~     subjects will also neuropsychological assessments. At the conclusion of the study, subjects~     will be asked to complete a final neuropsychological assessment, MRI scan, PET scan and~     blood draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess~     inflammatory markers if outcomes are positive.~      FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau~     tangle- proteins in the brain; the MRIs will be used to monitor supplement side effects and~     measure brain structure; the neuropsychological assessments will monitor rates of cognitive~     decline; the blood draws will be used to test levels of inflammatory markers.~   "
127769|NCT01383148|"~     This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the~     efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV~     non-small cell lung cancer (NSCLC).~      TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain)~     carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has~     been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1~     antigen.~      TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a~     non-specific activation of several components of the immune system.~   "
127770|NCT01383135|"~     The purpose of the study is to conduct a pilot test of a new tracer in healthy human~     volunteers to define normal tracer biodistribution (where the tracer goes), stability (how~     much metabolises), pharmacokinetics (how much stays in which organs and for how long), and~     radiation dosimetry (organ radiation dose). The same radiopharmaceutical will then be tested~     in cancer patients.~   "
127771|NCT01383122|"~     Pain following Cesarean delivery remains the most common post-operative complaint, and the~     provision of effective and safe analgesia is very important. Pain can impede the mother's~     ability to mobilise, and to care for and breastfeed her newborn baby.~      Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings,~     especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to~     accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side~     effects.~      Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain~     inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting~     undesirable side effects will enhance maternal satisfaction and reduce the risk of~     post-operative complications.~      The investigators hypothesize that the continuous use of a PEMF device for 48 hours after~     Cesarean delivery will result in decreased post-operative pain scores on movement at 48~     hours.~   "
127772|NCT01383109|"~     The combination of pyronaridine and artesunate is an antimalarial therapy in development.~     This Mass Balance study is intended to determine the rate and extent of excretion of total~     radioactivity in urine and faeces following administration of a single oral micro-dose of~     14C-pyronaridine in humans.~   "
127774|NCT01383083|"~     The prevalence of PAH associated with congenital systemic-to-pulmonary shunts in Western~     countries has been estimated to range between 1.6 and 12.5 cases per million adults, with~     25-50% of this population affected by Eisenmenger's syndrome. The rarity of this syndrome,~     combined with its complex pathophysiology, account for the insufficient understanding of the~     principles underlying its proper treatment.Recent decades have seen developments in~     pulmonary hypertension pathophysiology which have led to the introduction of new groups of~     drugs: prostacycline analogs (Epoprostenol, Treprostinil, Beraprost, Illoprost),~     phosphodiesterase inhibitors (Sildenafil, Tadalafil), endothelin receptor antagonists~     (Bosentan, Sitaxantan, Ambrisentan) and nitric oxide. These drugs should be administered to~     patients in III-IV NYHA class. Despite successful early results, the therapeutic effect on~     patients with Eisenmenger syndrome has not been conclusively established The treatment~     strategy for patients with PAH associated with congenital systemic-to-pulmonary shunts and,~     in particular, those with Eisenmenger's syndrome is based mainly on clinical experience~     rather than being evidence based. Although Eisenmenger's syndrome is uncurable disease, the~     survival rate is relatively higher than primary PAH, and the patients with Eisenmenger's~     syndrome are relatively younger group. So the improvement of exercise tolerance and quality~     of life is very important. Several randomized controlled trial reported favourable short-~     and long-term outcomes of treatment with the orally active dual endothelin receptor~     antagonist bosentan in patients with Eisenmenger's syndrome. However, there was scare data~     of outcomes of treatment with the inhaled iloprost in patients with Eisenmenger's syndrome.~     In Korea, most of patients with Eisenmenger's syndrome are treated with conservative therapy~     instead of administration of PAH-specific drug, because of lack of clinical experience.~     Moreover, oral agent such as bosentan, sidenafil is preferred than iloprost becase of more~     evidence and convenience. Our therapeutic efforts should be directed mainly towards~     preventing complications. As a rule, we should avoid agents with no established therapeutic~     efficacy and try to alleviate symptoms without any additional risk, so as not to disrupt the~     existing clinical balance.~      In this study, we investigate to know the clinical benefit of iloprost on patients with~     Eisenmenger's syndrome by the use of functional and hemodynamic parameters, which would add~     the evidence of PAH-specific agents on the Eisenmenger's syndrome~   "
127775|NCT01383070|"~     Primary hypotheses~      In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester~     of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5%~     increase in EBF by retraining in BFHI alone in both groups from baseline and a additional~     7.5% improvement in intervention group as compared to the control) compared with women with~     from hospitals with only retraining BFHI.~      Secondary hypotheses As compared to women from hospitals receiving only retraining in BFHI,~     those with additional cell phone lactational counseling will experience the following~        -  Increase in the percentage of EBF(breast milk and no other foods or milk based liquids)~          at 24 weeks after delivery,~        -  Increase in the mean duration of any breastfeeding,~        -  Increase in the percentage with TIBF,~        -  Reduction in use of pre lacteal feeds~        -  Reduction in percentage of infants being bottle fed(any liquid or semi-solid food from~          a bottle with nipple/teat) any time before or at 24 weeks~        -  Increase in the percentage of infants at 26 weeks after delivery who receive TICF,~        -  Increase in growth velocity (weight, length and head circumference)~        -  Reduction in the number hospitalizations or mortality in the mother-infant dyad till 26~          weeks after delivery~        -  Increase in adherence to visit schedules~        -  Greater ratio of effectiveness as compared to costs incurred for cell phone counseling.~   "
127776|NCT01383057|"~     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to~     create a clear corneal incision during cataract surgery.~   "
127777|NCT01383044|"~     Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in~     prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in~     prophylaxis of the first bleeding is still unknown. This study aims to investigate the value~     of combination therapy.~   "
127778|NCT01383031|"~     The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic~     results of transumbilical laparoendoscopic single site cholecystectomy.~   "
127779|NCT01383018|"~     The purpose of this observational registry is to collect and better understand real-world~     outcomes for men undergoing penile implant surgery to treat erectile dysfunction.~   "
127780|NCT01383005|"~     Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease~     inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).~      Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected~     patients to request a specific antiretroviral, the aim of this study is to assess both~     patient's perception of and adherence to Kaletra once-a-day, as well as with which factors~     they are related.~   "
127781|NCT01382992|"~     EGFR mutations plays an essential role in EGFR-TKIs treatment. However, for some patients,~     tissue samples are not available. The purpose of this study is to determine whether blood~     sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma~     sample is an alternative for detecting EGFR mutations.~   "
127782|NCT01382979|"~     The study examined whether an online course for college freshmen (AlcoholEdu) had an effect~     on alcohol misuse and related problems, using a randomized controlled design with 30~     universities.~   "
127783|NCT01382966|"~     Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans,~     was originally believed to be a non-classical Bone morphogenetic protein (BMP)~     antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH)~     signal transduction.~      Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral~     metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the~     perspective from which many of its features and treatment are viewed. Calcium, phosphate,~     parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of~     survival associated with kidney diseases. Now ROD dependent and independent of these factors~     is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an~     underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the~     elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the~     view of ROD.~      Emerging current data suggests a promising role for serum measurements of sclerostin in~     addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D~     patients (dialysis patients).~      Because of the close relationship between ROD and cardiovascular disease, the aim of this~     study is to investigate the association between sclerostin, arteriovenous fistula~     thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis~     patients.~   "
127798|NCT01382771|"~     Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment~     and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who~     have failed conservative therapy including physical therapy, have had an initial >80% pain~     relief on a diagnostic medial branch block, and are scheduled to undergo a routine second~     medial branch block for facet mediated pain will be randomized. Both groups will receive the~     standard of care, a medial branch block. The treatment group will also receive one set of~     intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive~     intra-articular normal saline.~   "
127784|NCT01382953|"~     The purpose of this research is to simplify the standard recording system of the heart~     rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24~     hours. The investigators intent is to use a very small, innovative monitoring patch system~     that relieves the patient of wearing a cumbersome and uncomfortable recording system. This~     research trial will carry the title The Simple ECG Monitoring for Comparison of a Sternal~     ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data~     from the investigational device is for comparative purposes only. It will not be used by~     medical personnel for study subject treatment or diagnostic purposes.~   "
127785|NCT01382940|"~     This study was designed to evaluate the safety of administering rituximab at a more rapid~     infusion rate in patients with moderate to severe rheumatoid arthritis who have had an~     inadequate response to biopharmaceuticals that treat diseases by interfering with tumor~     necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than~     eight weeks.~   "
127786|NCT01382927|"~     General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation,~     especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In~     this study, the investigators are comaparing obese patients undergoing hip arthroplasty in~     GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is~     assessed by eletrical impedance tomography (EIT).~   "
127787|NCT01382914|"~     The purpose of this study is to daily monitor the discoloration of teeth when participants~     rinse with a mouth rinse and black tea and to determine the time point when unacceptable~     discoloration occurs.~   "
127788|NCT01382901|"~     The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous~     (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless~     Legs Syndrome (RLS)~   "
127789|NCT01382888|"~     The primary objective of this study is to evaluate the effect of topically applied heparin~     in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas~     in patients planned for haemodialysis at 7th week (± 1 week) after first study drug~     administration.~   "
127790|NCT01382875|"~     Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and~     account for 12% of the disease burden in elderly aged 65 or above.~      A good management healthcare program and training helps elderly to restore full functional~     level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong~     lacks of such program. Some reports from other countries pointed out a well-organized~     multi-disciplinary management programs are cost-effective to identify and treat~     osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of~     fragility fracture.~      This study aims to compare the cost-effectiveness of multi-disciplinary management program~     with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall~     rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility~     hip fracture patients in New Territories East receiving the proposed management program will~     be compared with those from Kowloon Central with usual care as controls. The findings will~     provide useful data for the policy maker to evaluate the current clinical service for~     fragility fracture patients and consider the implementation of new multi-disciplinary~     management program into our healthcare system.~   "
127791|NCT01382862|"~     The purpose of this prospective study in acute ischemic stroke patients is to compare~     alarm-to-needle time during randomly allocated periods with and without availability of a~     specially staffed ambulance equipped with computed tomography (CT) and point-of care~     diagnostics. The investigators hypothesize that compared to regular care the investigators~     will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke~     emergency mobile unit.~   "
127792|NCT01382849|"~     Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes~     in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study~     is to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in~     patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to~     amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These~     accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid~     angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a~     low level of gamma rays which can be detected by a PET camera.~      MRI detected microbleeds have been identified as markers of clinically silent hemorrhage~     from bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is~     the spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to~     be associated with Aß deposition in the brain or predispose patients to higher risks of~     bleeding. This research study will explore the interactions of these factors and understand~     the physiology of intracerebral bleeding.~   "
127793|NCT01382836|"~     As part of ongoing efforts to determine the causes of asthma and the progression of the~     disease, this study will gather data to explore the interaction of genetic and environmental~     factors in the cause and severity of asthma in inner city children.~   "
127794|NCT01382823|"~     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to~     create a clear corneal incision during cataract surgery.~   "
127795|NCT01382810|"~     The purpose of this study is to evaluate and compare the effects of Altaire Gel forming~     solution and Refresh Tears in mild-moderate dry eye patients.~   "
127796|NCT01382797|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37~     when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).~   "
127797|NCT01382784|"~     There is growing evidence that psoriasis is a systemic disorder which enhances~     atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown~     an independent association between psoriasis and atherosclerosis, stroke and coronary artery~     disease. The main goal of this on-going study is to register data which will enable the~     identification of new markers of atherosclerosis activity and carotid plaque instability in~     patients with severe psoriasis.~   "
127825|NCT01382420|"~     Objective:~      To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of~     adrenal incidentaloma.~      Methods:~      234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into~     two groups(e.g adrenalectomy group and conservative treatment group).~   "
127799|NCT01382758|"~     One in a hundred children is born with a heart defect. Some children require heart surgery~     within the first few days of life, while others can wait until they are older. A~     complication of open-heart surgery is low blood flow due to the heart-lung machine that can~     cause sudden loss of kidney function known as acute kidney injury (AKI). AKI causes~     complications that can increase hospital length of stay and increase risk of death. Current~     ways to identify AKI are not able to it until 2 or 3 days after it has occurred. Because of~     this, there is not a specific treatment for AKI. If the investigators diagnose AKI early,~     they might be able to treat it and improve outcomes in children. NIRS is a skin monitor that~     can detect low blood flow to the kidney and might help diagnose AKI when it occurs in the~     operating room. The use of NIRS to diagnose AKI early is the focus of this study.~   "
127800|NCT01382745|"~     The objective of this study is to demonstrate the feasibility of using Nimotuzumab and~     radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve~     a 65% local control rate with a better toxicity profile than the conventional treatment.~     Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this~     study.~   "
127801|NCT01382732|"~     Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients~     with severe preeclampsia there is an increased risk of postpartum hemorrhage but the~     hemodynamic changes associated with this pathology make the management of any kind of~     bleeding particularly troublesome. There are many pharmacological options, being oxytocin~     the first line of treatment. However there is no evidence about the safety and efficacy of~     carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin~     for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.~   "
127802|NCT01382719|"~     This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of~     bremelanotide, administered subcutaneously on an as-needed basis under conditions of home~     use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire~     disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.~   "
127803|NCT01382706|"~     This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as~     second-line therapy works in treating patients with stage IV bladder cancer that cannot be~     removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill~     more tumor cells.~   "
127804|NCT01382693|"~     This project, a small-scale pilot study, will attempt to determine if involvement in a~     group-based creative expression program may correlate with a reduction in use of~     psychotropic drugs for persons with dementia.~   "
127805|NCT01382680|"~     In ERCP practice, most often a combined use of guidewires is necessary to attain a~     therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a~     stricture to a nitinol wire for improved stability with the use of therapeutic devices. A~     new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic~     tip. The investigators test the hypothesis that the use of this new guidewire would decrease~     number of guidewires used within one ERCP session.~   "
127806|NCT01382667|"~     The specific aim of the study is to investigate the relationship between the development of~     dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI~     peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm~     well controlled for emesis.~   "
127807|NCT01382654|"~     The objectives of this study were to:~        -  Examine the tolerability of two formulations and two dose concentrations of epinastine.~        -  Select formulation(s) of epinastine for future studies by evaluating the individual~          sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected~          after each study drug administration and the subject preference ranking assessed at the~          completion of the study.~        -  Compare the preference of two formulations and two dose concentrations of epinastine~          compared to azelastine following a single dose of each in a randomized, double-blind,~          two-cohort, three-period crossover design.~   "
127808|NCT01382641|"~     The doctors participating in this study are looking to show improved vision with the HOYA~     AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of~     Revital Vision (neuro-sensory testing) in providing the highest potential for improved~     vision.~   "
127809|NCT01382628|"~     This is a pilot study examining tendon collagen, collagen cross-linking, and markers of~     tendon extracellular matrix metabolism in the Achilles tendon of diabetic patients with~     ulcerations and amputations of the lower extremity.~   "
127810|NCT01382615|"~     The purpose of this study is to collect a blood or bone marrow sample from patients with~     multiple myeloma and from volunteers without myeloma.~   "
127811|NCT01382602|"~     This is a clinical trial is to study the safety and effectiveness of autologous~     muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).~   "
127812|NCT01382589|"~     The purpose of this study is to determine whether afamelanotide and narrow band UVB are~     effective in the treatment of non-segmental vitiligo (NSV).~   "
127813|NCT01382576|"~     In the present study, serum chitotriosidase activity and its relationship with insulin~     resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).~   "
127814|NCT01382563|"~     Develop Registry tool~   "
127815|NCT01382550|"~     The aim of this study is to estimate the incidence of spontaneous and provoked recurrent VTE~     and the bleeding events during a 10-year follow-up in subjects experiencing a first VTE~     stratified according to % AT levels and to treatment schedule (long-term vs 6-12 months oral~     anticoagulation+transient prophylaxis during high risk periods)~   "
127816|NCT01382537|"~     This study will focus on the efficacy of treating 80 patients who have functional~     limitations in activity because of chronic/recurrent neck or shoulder pain.~      Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks~     1-2.~      Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared~     to those who received placebo treatment.~      Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit~     radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.~   "
127817|NCT01382524|"~     Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the~     U.S. in 2009. These short (< 3 inches) peripherally inserted IV catheters are vital for~     providing patients with needed: 1) fluid, electrolyte, nutrient and blood product~     replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters~     have inherent risks or potential complications which may result from poor catheter~     securement or stabilization.~      When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause~     injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing~     complication of PIV therapy. Additional complications of inadequate stabilization of the PIV~     catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement.~     According to Royer (2003), the most common reason for PIV catheter failure is infiltration~     and dislodgement. Infiltration is more dependent on keeping the extremity still, where~     phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids~     infused or by the physical trauma to the endothelium from IV pushes.~      The results of these complications are costly and can be serious if another vein cannot be~     immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled~     restart of another PIV catheter causes a delay in patient treatment, patient discomfort,~     patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual~     costs associated with PIV catheter restarts include materials and nursing resources; yet~     intangibles such as, treatment for patient complications and patient dissatisfaction may be~     far more costly.~      One way to reduce the incidence of PIV catheter-associated complications is to use~     technologies that help reduce catheter movement thereby improving catheter stabilization. In~     addition to stabilization platforms added to the peripheral IV catheter design, catheter~     stabilization devices and modified transparent film dressings also help to reduce catheter~     movement and could possibly eliminate the need for routine catheter site changes.~      Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related~     complications and PIV catheter restarts of one stabilization system to another stabilization~     system and 2) to determine which system provides a cost savings.~   "
127818|NCT01382511|"~     Simvastatin and related statins, such as compactin, are able to inhibit the constitutive~     expression of inducible/repressible keratin genes such as K6a and K17. This effect is due to~     the reported ability of statins to inhibit STAT1 expression (Lee et al., 2007). The~     constitutive K6a promoter activity is dependent on STAT1 and blocked by simvastatin or siRNA~     against STAT1. This STAT1-dependent constitutive expression of K6a, is independent of JAK~     (Janus family of kinases).~      Thus simvastatin is capable of down-regulating both the constitutive and~     interferon-inducible expression of PC-related keratins such as K6a and K17. Therefore, this~     class of molecule has potential for the treatment of PC or related inherited disorders where~     the causative mutation resides in an inducible/repressible keratin gene such as K6a or K17.~      Simvastatin or other statins approved for human use might be delivered either orally, as is~     currently the case for cholesterol-lowering treatment or, if higher therapeutic doses are~     required in skin for reduction of hyperkeratosis in PC or in related keratinizing disorders,~     this might be achieved by topical formulations.~   "
127819|NCT01382498|"~     Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2~     diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of~     diabetic retinopathy showing a slowdown of the progression of the disease after long-term~     oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent~     vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in~     the failure of autoregulation that it is an important and often early feature of diabetic~     retinopathy.several studies have been confirmed that inflammation besides oxidative stress~     are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in~     detecting inflammation in these patients. The aim of this study was to determine the effects~     of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.~   "
127820|NCT01382485|"~     The specific question the investigators will seek to answer is: can the Reamer Irrigator~     Aspirator (RIA) provide a bone graft source for the treatment of nonunions that is equally~     effective to Autogenous Iliac Crest Bone Graft (AICBG) while resulting in a decreased amount~     of post-operative pain and a lower rate of complications?~   "
127821|NCT01382472|"~     In this mechanistic pilot study in 40 patients the investigators will compare the findings~     in patients treated with very early high dose statin therapy with historic controls from the~     KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose~     statin therapy in patients treated with primary PCI:~        1. reduces area of myocardial infarction, reduces volumes and improves remodelling as~          assessed by MRI at 2 days and at 2 months~        2. improves microcirculation (Decreased number of patients with MO) as assessed by first~          pass time estimated with MRI 2 days~        3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI~          frame count immediately after PCI~        4. reduce levels of CK-MB and TnT measured as area under the curve during the hospital~          stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and~          neurohormones at discharge and at 2 months follow-up~        5. improves endothelial function assessed by flow mediated vasodilatation at discharge~        6. alters Peak VO2 at 1 and 6 month~        7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at~          follow-up alters collagen turnover~   "
127822|NCT01382459|"~     The investigators assume that an intervention program that includes home visits and~     trainings of diabetes' nurse and dietitian will lead to an improvement of the patients'~     metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an~     economic streamlining.~   "
127823|NCT01382446|"~     Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol~     for trauma patients on ventilator support to decrease the incidence of Ventilator Associated~     Pneumonia and oral bacterial load.~   "
127824|NCT01382433|"~     The aim of the current study is set out to find a human model for negative symptoms based on~     clinical observation that chronic cannabis users express negative symptoms and characterize~     by the same neurocognitive and electrophysiology characteristics like patient suffer from~     schizophrenia. Towards that end the first part of the study is set out to explore weather~     chronic cannabis user's express negative symptoms similar to patient suffer from~     schizophrenia. The second part of the study will explore the neurocognitive and~     electrophysiology characteristics of those cannabis users that express negative symptoms.~     This data will be compared to parallel data of schizophrenia patients with predominantly~     negative symptom.~      Several lines of biological and genetic evidence support the cannabinoid hypothesis for~     schizophrenia. Particularly, it is most significant clinically that the possible involvement~     of the cannabinoid system in the neural basis for the negative symptoms. This hypothesis~     based on clinical findings that chronic cannabis use causes a combination of symptoms~     including apathy, avolition, lack of interest, passivity, and cognitive impairments, the~     so-called amotivational syndrome, which resembles the core negative symptoms of~     schizophrenia in behavioral level as well as the brain level. Both are associated with the~     functions or integrity of the frontal lobe due to its role in creating self-directed~     behaviors, deficits in which may underlie alogia, anhedonia, and flat affect. Despite the~     aforementioned similarities, to date, there is no documentation for such a relationship.~     Recognition that chronic cannabis users share the same or similar constellation of symptoms~     and similar neurocognitive and electrophysiology characteristics could provide a key to~     develop a human model for negative symptoms and an essential tool to comprehensive~     understanding of the etiology of negative symptoms and development of an innovative therapy.~      The investigators Hypothesize That Chronic Cannabis Users Would Express the Same~     Constellation of Behaviors as Negative Symptoms of Schizophrenia; as well as similar~     neurocognitive and electrophysiology characteristics~   "
127826|NCT01382407|"~     The hypothesis of this study is that patients who suffered from acne vulgaris during~     adolescence are at greater risk of developing acneiform skin rash due to cetuximab.~   "
127827|NCT01382394|"~     Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid~     volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to~     the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation~     that exhibits significant prognostic value in predicting severity and outcome of sepsis.~     Recently, it was suggested that inflammatory cytokines play an important role in the~     development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is~     normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT~     remain very low, a dramatic increase in serum PCT levels is observed during severe systemic~     infections. These properties make procalcitonin less useful for the diagnosis of simple~     infections but a very promising marker of severe infections especially in the critical care~     setting.~      To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of~     patients; those presenting with the diagnosis of decompensated heart failure and in patients~     presenting with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.~   "
127828|NCT01382381|"~     The goal of the study is to evaluate long term durability and hemodynamic effect of~     implanted stents in the aortic arch and in pulmonary artery branches.~   "
127829|NCT01382368|"~     -  Pulmonary diseases are increasingly important causes of morbidity and mortality in the~          modern world.~        -  Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor,~          targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of~          Pulmonary Arterial Hypertension (PAH) in 2005.~        -  The aim of the suggested study is to examine the acute effect of oral intake of~          sildenafil on exercise tolerance and functional capacity in Chronic Obstructive~          Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy~          patients.~        -  The investigators hypothesize that oral ingestion of sildenafil prior the exercise may~          enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy~          patients.~        -  Patients and Methods:~      Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD~     III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.~        -  All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on~          bicycle ergometer in different days; 60 min after intake of placebo and 60 min after~          intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.~        -  In first meeting prior exercise test at rest standard pulmonary function test,~          diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and~          blood samples for NT-proBNP will be taken prior and post each CPET.~        -  After 15-20 minute of passive recovery post exercise test all patients will perform 3~          short functional tests including 6 minute walk test to assess functional capacity.~   "
127830|NCT01382355|"~     Advances in transplant pharmacotherapy have led to improved one-year patient and graft~     survival in kidney transplant recipients, but have not translated to enhanced long-term~     survival. An explanation for the disparity in outcomes is the negative role of antibodies in~     transplant graft survival. There currently does not exist maintenance immunosuppression that~     targets antibodies and standard of practice aims at removing circulating donor specific~     antibodies upon detection of antibody mediated graft damage but not prior to the detection~     of rejection. There exists an insufficiency of data regarding patient and donor~     characteristics, changes in immunosuppression, the risk of viral donor and patient~     seropositivity and the risk of non-compliance on the development of antibodies. By measuring~     antibody levels in the blood at specific time periods after transplant, we may have a better~     understanding of what types of patients will develop antibodies, when these antibodies~     appear and how changes to transplant medications may affect antibodies.~      The proposed project will examine the multifactorial risks associated with the development~     and appearance of donor-specific antibodies in the first year post-kidney transplant. The~     data collected will provide a historical perspective and preliminary pilot data to support a~     proposal for prospective antibody monitoring and to justify pre-emptively treating the~     antibodies in the absence of clinical signs of rejection.~   "
127831|NCT01382342|"~     While Parkinson's disease has historically been defined in terms of its motor~     symptomatology, studies have shown that non-motor deficits form an important part of the~     syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease.~     These deficits are often subtle and do not rise to the level of impairment necessary for a~     diagnosis of dementia; however these deficits are discernable with neuropsychological~     testing and may produce subjective complaints of cognitive decline and mild functional~     difficulties in some patients. The traditional pharmacological interventions for Parkinson's~     disease have focused on controlling and alleviating motor symptoms with levodopa and~     dopamine agonists. However, these medications treat the symptoms of PD, but do not alter the~     course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B~     inhibitor, has recently shown benefits consistent with a possible disease-modifying effect.~     Given the positive and intriguing findings seen with treatment with rasagiline, the~     investigators propose to study the effects of this medication on cognition in patients with~     mild to moderate stage Parkinson's disease.~      Hypotheses:~        1. Rasagiline will improve cognitive function, as measured by performance on~          neuropsychological tests in PD patients who do not suffer from dementia.~        2. Rasagiline will not negatively affect neuropsychiatric functioning.~   "
127832|NCT01382329|"~     The purpose of this study is to obtain immunogenicity and safety data of two different dose~     levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18~     to 59 years.~   "
127842|NCT01382199|"~     The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human~     Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in~     Adult Patients.~   "
127854|NCT01382043|"~     The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been~     demonstrated in randomized clinical trials as well as in real world practice. Theoretically,~     a new DES with a biodegradable polymer should reduce the incidence of late in-stent~     thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This~     study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable~     polymer to the Endeavor DES with a biocompatible polymer in same individuals.~   "
127923|NCT01381146|"~     The purpose of this study is to evaluate feasibility of modularized delivery of the Impact~     of Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its~     effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.~   "
127833|NCT01382316|"~     This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a~     manual-guided intervention designed to help alcohol and drug dependent clients connect with~     individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was~     determined by comparing abstinence rates of participants recruited during ON (MAAEZ~     intervention) and OFF (usual care) conditions and by studying the effect of the number of~     MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12~     months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from~     alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ~     session received. MAAEZ appeared especially effective for those with more prior AA exposure,~     severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ~     (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having~     a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents~     an evidence-based intervention that is easily implemented in existing treatment programs.~   "
127834|NCT01382303|"~     This multi-center, randomized controlled study aims to evaluate the effects of~     pentoxifylline on proteinuria in Korean type 2 diabetic patients.~   "
127835|NCT01382290|"~     Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established~     method for detecting acute injury to the brain and is used on all children undergoing an MRI~     brain scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study~     other areas of the body, such as the spinal cord, has been recognised as having great~     clinical potential. However, two main problems have hindered the clinical application of the~     technique; firstly, the extreme motion sensitivity of the technique meant that respiratory~     motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to~     the bones in the spinal column complicates the application of the techniques developed for~     the brain to the spine. Recently, several techniques have been developed which address these~     problems and these are now available on the MRI scanners used at Children's Healthcare of~     Atlanta.~      We now wish to evaluate how well these techniques work on children in a routine clinical~     setting. For this reason we wish to add a single scan of the spine to the imaging protocol~     of children receiving a routine scan of the brain or spine. This will permit us to evaluate~     the image quality in both normal and abnormal spines. We plan on enrolling 60 patients with~     normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast~     will be required and the additional imaging time for the diffusion studies will be less than~     10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the~     study.~   "
127836|NCT01382277|"~     This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20~     mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart~     disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice~     spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also~     evaluated.~   "
127837|NCT01382264|"~     The primary purpose of this study is to determine whether the use of a computer assisted~     decision support (CADS)system by primary care providers (PCPs) for their patients with type~     2 diabetes mellitus (T2DM) changes the quality of care relative to a usual care group in~     terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose,~     frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.~   "
127838|NCT01382251|"~     The purpose of this study is to assess the functional recovery of older ambulatory surgical~     patients and the impact of the current model of care on the caregivers of these patients.~     This study will provide unique insight into the challenges patients and their families face~     following surgery.~      The primary objective of this study is to:~        1. Assess the impact of ambulatory surgery on functional capacity as assessed by the~          Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following~          surgery in a population of surgical patients 65 years of age and older.~           Secondary objectives are to determine if:~        2. Changes in the patient's functional capacity result in increased burden of care as~          assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.~        3. Changes in functional capacity are correlated with decrements in quality of life as~          assessed by the Short Form 12 (SF12).~        4. Changes in functional capacity are correlated with inadequate postoperative analgesia~          as assessed by the Brief Pain Inventory (BPI).~   "
127839|NCT01382238|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical~     trials for the treatment of human immunodeficiency virus (HIV) infection. A granule~     formulation has been developed as an alternative to the current tablet formulation for~     administration in pediatric populations.~      This is a single-center, randomized, open-label, 5-way crossover study in healthy adult~     subjects. The study will evaluate the relative bioavailability of a 50 mg granule~     formulation of dolutegravir when administered 1) directly to mouth; 2) with purified water;~     3) with Contrex brand water; and 4) with milk-based infant formula compared to the current~     50 mg tablet formulation administered with tap water. Safety evaluations and serial PK~     samples will be collected during each treatment period. A taste assessment of the granule~     will also be performed. A follow-up visit will occur 5-7 days after the last dose of study~     drug.~      Pharmacokinetic assessments during the study will include area under the concentration-time~     curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under~     the concentration-time curve from time zero (pre-dose) to last time of quantifiable~     concentration within a subject across all treatments (AUC(0-t)), maximum observed~     concentration (Cmax), terminal phase half-life (t½), lag time before observation of drug~     concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), concentration at~     24 hours post-dose (C24), and apparent clearance following oral dosing (CL/F).~   "
127840|NCT01382225|"~     The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in~     treating the signs and symptoms of dry eye disease.~   "
127841|NCT01382212|"~     The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages~     10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving~     peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism.~     Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the~     incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be~     enrolled and all 12 will receive paricalcitol capsules.~   "
127843|NCT01382186|"~     Deployment of Secure Messaging (SM) in primary care and women's clinics throughout the~     Veteran Health System by 2011 was an implementation priority for the Secretary and Under~     Secretary for Health for FY11 under the VHA T21 initiative. Secure Messaging is in early~     phases of implementation, this eHealth tool requires thoughtful evaluation to promote the~     successful implementation and dissemination of this tool. The primary aim of this project is~     to describe Veterans' experiences when using the SM feature on MyHealtheVet (MHV). This~     project has local, VISN, and national impact on the implementation and sustainability of the~     SM feature on MHV through its qualitative and quantitative examination of users'~     experiences. Findings from this research explores why Veterans choose to, or not to, use the~     SM feature on MHV, identify facilitators and barriers, and examine if experiences differ by~     health literacy or computer literacy. In addition to the interview data, findings from the~     usability testing and the quantitative survey findings build knowledge about Veterans'~     experiences using the SM feature on MyHealtheVet. These data will inform systems~     improvements, educational approaches, and marketing strategies to increase adoption and~     long-term utilization among Veterans.~   "
127844|NCT01382173|"~     Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes,~     the overall aim of this study is to investigate structural injuries and biochemical~     alterations in the acutely injured knee and to relate these findings to clinical outcomes at~     various time points.~   "
127845|NCT01382160|"~     Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α)~     approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs~     (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously~     treated with methotrexate.~      However, almost one third of patients have no response and approximately 15% develop~     antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a~     relationship between adalimumab concentration and clinical response obtained after 6 month~     of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems~     to predict the clinical response at 6 months.~      There is an important inter individual pharmacokinetic variability of adalimumab. Side~     effects may occur at the recommended dose and more than 3 months of treatment are generally~     required to estimate the clinical response.~      A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the~     response and to avoid dose related side effects. To date there is no definite adalimumab~     target concentration predictive of the clinical response to allow such a pharmacologic~     monitoring.~   "
127846|NCT01382147|"~     Evaluation weather early chemotherapy attempts for remission induction can improve the~     results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.~   "
127847|NCT01382134|"~     Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of~     aspirin, hemodilution and mild hypothermia~      Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to~     increased surgical bleeding and increased transfusion requirement during surgery. Although~     this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is~     not always possible or desirable.~      Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in~     uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a~     recent study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose)~     is already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have~     demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted~     sample predicts increased postoperative bleeding after total knee replacement.~      We have therefore designed this study as a follow up to our last two studies on DDAVP and~     hypothermia, to investigate whether hemodilution affects hypothermia induced platelet~     dysfunction and the response to DDAVP. In addition, another common cause of perioperative~     platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients.~     Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response~     to DDAVP, will also be investigated.~   "
127848|NCT01382121|"~     The purpose of this study is to implement a peer modeling intervention to improve~     self-efficacy and aerobic fitness in obese youth. A total of 40 obese (defined as Body Mass~     Index greater than the 95th percentile for age and gender) youth will participate in this~     study.~   "
127849|NCT01382108|"~     The purpose of this study is to look at both the meibomian glands and the tear film using a~     new clinical instrument marketed in Canada which was recently acquired by the Centre for~     Contact Lens Research. These will be compared between two groups of individuals, one group~     with visible meibomian gland dysfunction (MGD) and one group of individuals with normal~     meibomian gland appearance. The hypothesis is that there will be a difference between normal~     individuals and individuals with MGD with respect to the appearance of the meibomian glands~     and certain tear film attributes.~   "
127850|NCT01382095|"~     The purpose of the study is to determine if immunization with a recombinant E. coli protein,~     dscCfaE, is safe and immunogenic when administered through the skin using a patch.~   "
127851|NCT01382082|"~     Cognitive impairments in cancer patients represent an important clinical problem. Studies to~     date estimating prevalence of difficulties in memory, executive function, and attention~     deficits have been limited by small sample sizes and many have lacked healthy control~     groups. More information is needed on promising biomarkers and allelic variants that may~     help to determine the etiology of impairment, identify those most vulnerable to impairment,~     and develop interventions for these difficulties.~      This is a longitudinal observational study of cognitive function in breast cancer and~     lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive~     difficulties (i.e., problems with memory, executive function, and attention) in these~     populations.~   "
127852|NCT01382069|"~     The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU)~     as a male hormonal contraceptive.~      The study has two parts. The first is a dose escalating study in healthy to assess the~     safety and tolerability of single dose oral administration of DMAUin healthy men.(Completed)~      The second is to study the safety and tolerability of DMAU after 28 days of repeated daily~     dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will~     also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral~     administration of DMAU.~   "
127853|NCT01382056|"~     Consumption of a diet containing pulse crops provides flavonoid compounds that will improve~     vascular function and glycemic control in individuals with Peripheral Artery Disease.~   "
127856|NCT01382017|"~     This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor~     cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover~     trial in young healthy human subjects, and to compare the pattern of excitability changes~     induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation~     of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast~     inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium~     channels by LCM is a novel manner to modulate sodium channels and leads to normalization of~     activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby~     effectively controlling neuronal hyperexcitability without affecting physiological activity~     (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be~     better tolerated in clinical settings while being as or even more effective in controlling~     seizure activity. On the basis of the results from nonhuman studies, it is hypothesized that~     the TMS profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical'~     sodium channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor~     thresholds indicating reduced neuronal membrane excitability, without developing significant~     changes of synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et~     al., 1997; Lee et al., 2005). Because of its novel mode of action it can only be speculated~     which TMS parameters LCM might affect. For example, more than exclusively affecting neuronal~     membrane excitability, LCM could possibly also affect inhibitory mechanisms such as short-~     and long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993).~     This would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al.,~     1996; Reis et al., 2002; Lang et al., 2006).~   "
127857|NCT01382004|"~     Yaws, an endemic treponematosis and as such a neglected tropical disease (NTD), is currently~     making a comeback in children in rural areas. Injectable long acting penicillin remains the~     drug of choice for the treatment of yaws. However, on the basis of successful experience~     with venereal syphilis in large-scale studies, oral azithromycin has emerged as a potential~     alternative that overcomes the major medical and logistic disadvantages of the current~     regimen.~      In this non-inferiority randomized clinical trial the investigators propose a comparable~     scheme for the treatment of yaws, to test the efficacy of a single, oral dose of~     azithromycin versus a single, i.m. dose of benzathine penicillin G.Sample size has been~     calculated to detect a non-inferiority margin of 10%. Children < 15 years of age with a~     confirmed diagnosis of yaws will be randomly assigned to receive 30mg/Kg (maximum 2g) of~     azithromycin orally or 50.000units/Kg (maximum 2.4MU) of penicillin-G-benzathine~     intramuscularly. The primary outcome is treatment efficacy, with cure defined serologically~     (a decline in the VDRL titer of at least two dilutions by six months after treatment) and,~     in primary yaws, also by epithelialization of ulcers within two weeks.~   "
127858|NCT01381991|"~     Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal~     reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be~     assessed. However, there were some limitation in diagnosis of GERD using endoscopy~        1. More than half of patients with GERD reveal no visible abnormality on conventional~          endoscopy, it is possible that minute mucosal changes are underestimated by~          conventional endoscopy due to the limitation of visual ability~        2. In addition of uncertainty in detecting mucosal breaks, uncertainty in describing~          severity of mucosal injury can lead to inconsistency among interpreters. Interobserver~          agreement regarding diagnosis and classification of GERD using endoscopy is~          unsatisfactory to apply daily practice.~      Thus, the development of a new method to define the intra-esophageal injury for use in daily~     practice is a worthwhile endeavor and developed, such as narrow−band imaging (NBI), Fuji~     Intelligent Chromoen−doscopy (FICE) and i-scan.~      Among them, i-scan technology is the most recently developed image enhancing technology,~     which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast~     enhancement (CE), and tone enhancement (TE).~      Thus, the investigators examined the hypothesis that i-scan can improve the detection rate~     of reflux esophagitis and inter-observer agreement between endoscopists compared with~     conventional white light (WL) endoscopic examination.~   "
127859|NCT01381978|"~     Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and~     physical activity habits.~      Summary:~      The prevalence of obesity and overweigh in all age groups are increasing rapidly in the~     world. Some factors like physical activity, socioeconomical status, dietary habits, gender,~     besides genetic factors influence in the development of obesity.~      In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in~     children and the risk factors related.~      Socioeconomical status and quality of physical activity are assessed using specially~     designed questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca~     city. Nutritional status is assessed using body mass index, relation weight/age and~     height/age. These data are helpful to develop programs focused to improve nutritional status~     in scholars of Cuenca.~   "
127860|NCT01381965|"~     Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the~     repair of photoreceptor cone outer segment tips defect is significantly correlated with the~     visual outcomes after macular hole surgery.~   "
127861|NCT01381952|"~     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise~     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose~     significantly. This is realized by anatomy-specific optimization of the full acquisition~     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing~     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and~     shorter pulses are used, which are known to positively influence image quality . The final~     effect on the clinical image quality is investigated in this study.~   "
127862|NCT01381939|"~     Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common~     procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical~     approach has not been evaluated as to delivery complications and fetal outcome as yet. The~     investigators now examine weather ICP affects (i) delivery procedures chosen, in particular~     the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and~     (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based~     on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet,~     Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history~     and medical book data. Primary endpoint is the risk of caesarian section.~   "
127907|NCT01381354|"~     The study will use a multimodal therapeutic lifestyle intervention consisting of a study~     diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food~     allergy, meditation, self massage, progressive exercise and neuromuscular electrical~     stimulation for rehabilitation of gait and fatigue disability in the setting of secondary~     and primary progressive multiple sclerosis with gait disability.~   "
127908|NCT01381341|"~     A pharmacokinetic study to compare 2 clinical formulations of linifanib.~   "
127863|NCT01381926|"~     The purpose of this study is to determine changes in bone turnover markers and calcitonin~     following the initiation of exenatide compared to placebo in postmenopausal women wtih type~     2 diabetes.~      Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline~     phosphatase) will be lower and bone formation (measured by type I collagen crosslinked~     aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with~     exenatide compared to when subjects are treated with placebo.~      Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment~     with exenatide vs. placebo.~   "
127864|NCT01381913|"~     Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a~     poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are~     performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local~     tumor control compared with NAC. This feasibility trial explored the feasibility and safety~     of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.~   "
127865|NCT01381900|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of the~     addition of canagliflozin relative to the addition of placebo in patients with inadequate~     glycemic control on metformin alone or in combination with a sulphonylurea.~   "
127866|NCT01381887|"~     The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose~     blood levels in patients with Type 2 Diabetes Mellitus.~   "
127867|NCT01381874|"~     The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate~     plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane,~     each compared with oral exemestane alone, in postmenopausal women with estrogen~     receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after~     treatment with letrozole or anastrozole.~   "
127868|NCT01381861|"~     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with~     recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.~   "
127869|NCT01381848|"~     The purpose of this study is to measure drug levels of doripenem in blood samples collected~     before and after administration of doripenem to infants less than 12 weeks of age who are~     hospitalized and documented, presumed to have, or are at risk for bacterial infection (s)~     and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability~     will also be assessed.~   "
127870|NCT01381835|"~     The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in~     participants with severe renal impairment and to compare these with the TMC435~     pharmacokinetics in matched participants with normal renal function. We will also study the~     short-term safety and tolerability of TMC435, when administered in participants with severe~     renal impairment and in participants with normal renal function. Steady-state is a term that~     means that the drug has been given long enough so that the plasma concentrations will remain~     the same with each subsequent dose. TMC435 is being investigated for the treatment of~     chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is~     absorbed into the bloodstream, distributed in the body, and eliminated from the body.~   "
127871|NCT01381822|"~     The primary objectives are:~      Dose escalation:~      1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib.~      Dose expansion:~        1. To make a preliminary assessment of the efficacy of TH-302 in combination with~          sunitinib as determined by the response rate and the progression-free survival in~          subjects with advanced RCC treated at the RP2D~        2. To assess the safety of TH-302 in combination with sunitinib and determine a~          recommended Phase 2 dose of the combination.~      The secondary objectives are:~      Dose expansion:~      1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib~     as determined by stable disease or better rate, duration of response and overall survival in~     subjects with advanced RCC treated at the RP2D.~      The exploratory objective is:~      1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.~   "
127872|NCT01381809|"~     The purpose of this study is to demonstrate that epoetin alfa works better than placebo in~     improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of~     epoetin alfa will also be evaluated.~   "
127873|NCT01381796|"~     The purpose of this research is to:~        1. Compare two study patches having minor differences in patch components~        2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates~          medication) of NP101 (study patches) versus a currently approved oral formulation of~          Imitrex~        3. Collect resistance data during application of NP101 (study patch)~   "
127874|NCT01381783|"~     The purpose of this study is to determine if topical anesthesia is safe for~     phacoemulsification in eyes with comorbidities.~   "
127875|NCT01381770|"~     The purpose of this study is to demonstrate that platelet-derived repairing factors are~     effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label,~     single arm, single centre has been designed. Sample size will be 25.~   "
127876|NCT01381757|"~     Background:~      -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed~     with a test that is fast and inexpensive but not always accurate. The purpose of this study~     is to test a new method for diagnosing TB, called the microscopic-observation~     drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also~     gives information on which drugs will work best in each case.~      Objective:~      -To test a new method for diagnosing tuberculosis called the microscopic observation drug~     susceptibility test.~      Eligibility:~        -  Participants must be 12 years of age or older.~        -  They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an~          x-ray indicating that TB is present.~      Design:~        -  Participants will take part in the study from 6 months to 21 months and be assigned to~          one of three groups, depending on what type of TB they have.~        -  At the first visit, researchers ask questions about general health and symptoms of TB.~          They check vital signs, draw blood, and ask for a sputum sample. The blood is used to~          check for HIV infection and for the number of CD4 cells, which measures the severity of~          the HIV infection.~        -  The 2-, 5-, and 6-month visits are similar to the first. Those who do not have~          multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR~          TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants~          with MDR TB will remain in the study for 21 months.~        -  No treatment is provided as part of this study.~   "
127877|NCT01381744|"~     Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis.~     Modern antibiotics are effective against plague, but if an infected person is not treated~     promptly the disease is likely to cause illness or death. The purpose of this study is to~     evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new~     research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine~     Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or~     placebo (inactive substance) one group at a time starting with the lowest dose working up to~     the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study~     procedures include: physical exam, blood samples, and recording temperature and side effects~     in a memory aid. Participants will be involved in study related procedures for about 13~     months.~   "
127878|NCT01381731|"~     The objectives of this trial are to:~        -  Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus~          placebo following one week of treatment in subjects undergoing photorefractive~          keratectomy (PRK).~        -  Evaluate the potential of diquafosol to accelerate corneal wound~          healing/re-epithelialization following PRK.~   "
127879|NCT01381718|"~     RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer~     treatment.~      PURPOSE: This phase II randomized trial studies how well modafinil works in treating~     children with memory and attention problems caused by cancer treatment for a brain tumor.~   "
127880|NCT01381705|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how well patients will~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to rituximab~     treatment in samples from patients with indolent follicular lymphoma.~   "
127881|NCT01381692|"~     This randomized phase I/II trial studies the side effects and the best dose of temsirolimus~     when given together with bortezomib, rituximab, and dexamethasone and to see how well they~     work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with~     untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or~     follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of~     cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab,~     can block cancer growth in difference ways. Some block the ability of cancer cells to grow~     and spread. Others find cancer cells and help kill them or carry cancer-killing substances~     to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with~     temsirolimus in treating non-Hodgkin lymphoma.~   "
127882|NCT01381679|"~     This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol~     Screening and Treatment project (ACT I), which assessed the cholesterol status, including~     achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in~     participants with coronary heart disease (CHD) already being treated with a statin. In this~     study, participants without adequate LDL-cholesterol reduction with a statin underwent~     extension of therapy with ezetimibe with the goal of achieving target levels.~   "
127883|NCT01381666|"~     The objective of the present work is to explore and compare the diagnostic quality of sputum~     specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316~     in patients diagnosed with interstitial lung diseases.~   "
127884|NCT01381653|"~     An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP;~     R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage~     high-risk young men who have sex with men (YMSM) via online social networking and aims to~     reduce both high-risk sexual behavior and drug use.~   "
127885|NCT01381640|"~     This is a single dose pharmacoscintigraphic study investigating the differences in~     paracetamol absorption between two formulations.~   "
127886|NCT01381627|"~     Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for~     22 865 new cases in 2007. Recent randomized trials have shown a significantly better~     diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided~     transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various~     clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are~     now routinely performed in our institution for staging of pulmonary and mediastinal cancer.~     EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the~     Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.~      Remifentanil, used in combined regime or as single agent proved to be effective and safe for~     MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression~     profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims~     demonstrated that respiratory depression remains a significant drawback during MAC in remote~     locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA~     are at increased risk of such complications.~      The investigators hypothesize that compared to the use of remifentanil-based MAC protocol,~     the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence~     of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation,~     hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure~     conditions.~   "
127909|NCT01381328|"~     The purpose of this study is to correlate the different patterns of resistance mutations~     observed in vivo in patients failing RAL treatment with the fold-change resistance~     determined by the phenotypic assay.~   "
127910|NCT01381315|"~     It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic~     drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk~     for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node~     dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of~     the breast during the procedure would potentially decrease the incidence of arm lymphatic~     disruption and subsequent development of lymphedema while providing adequate axillary breast~     nodes needed for staging.~   "
127887|NCT01381614|"~     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom~     burden is limited in commercially insured patients (age >= 18 years and < 65 years).~     Additionally, limited information exists on economic burden of adverse events associated~     with treatments for advanced/metastatic renal cell carcinoma. An objective of the current~     study is to estimate the incidence, prevalence, and symptom burden associated with~     advanced/metastatic RCC in a US real-world setting. Another objective is to quantify the~     economic burden of severe adverse events with agents used in management of first line~     advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will~     employ a retrospective cohort design. Analyses of health insurance claims data from a large~     commercially insured population will be employed in the current study. Study subjects will~     consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1,~     2000 and December 31, 2009; these persons will be identified based in part on~     case-ascertainment algorithms. Analyses will be directed at estimating annual rates of~     incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of~     common severe adverse events associated with treatments used in management of~     advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).~   "
127888|NCT01381601|"~     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom~     burden is limited in commercially insured adult patients. Additionally, limited information~     exists on economic burden of adverse events associated with treatments for~     advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate~     the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a~     US real-world setting. Another objective is to quantify the economic burden of severe~     adverse events with agents used in management of first line advanced/metastatic RCC~     (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective~     cohort design. Analyses of health insurance claims data from a large commercially insured~     population will be employed in the current study. Study subjects will consist of all~     persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December~     31, 2009; these persons will be identified based in part on case-ascertainment algorithms.~     Analyses will be directed at estimating annual rates of incidence and prevalence of~     advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events~     associated with treatments used in management of advanced/metastatic RCC (sunitinib,~     sorafenib, bevacizumab, and pazopanib).~   "
127889|NCT01381588|"~     This is an observational study to investigate the prevalence of osteoporotic fractures in~     post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery)~     including GHs(general hospitals) and clinics will be enrolled.~   "
127890|NCT01381575|"~     This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals'~     HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months~     and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose~     schedule (0,1,6 months) in 15-25 year old females.~   "
127891|NCT01381562|"~     This study is being conducted to evaluate the safety, efficacy and~     pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal~     infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use~     in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological~     activity that includes pathogens responsible for cIAI.~   "
127892|NCT01381549|"~     This study is being conducted to evaluate the safety, efficacy (clinical and~     microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it~     would be a suitable antibiotic for the treatment for febrile lower cUTI and~     pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to~     imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections.~     GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible~     for cUTI.~   "
127893|NCT01381536|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus~     (SLE).~   "
127894|NCT01381523|"~     The goal of this study is to measure medical resource utilization, treatment patterns, and~     costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of~     sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who~     are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The~     analysis will compare the mean number of prescription tablets used (including triptans,~     NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and~     pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a~     single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no~     difference will be observed between resource utilization and costs incurred by patients~     treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis~     is that one group will incur significantly fewer costs and/or significantly lower health~     care utilization. For the triptan switch analysis, the null hypothesis is that no difference~     will be observed in the costs or health care utilization between triptan patients who are~     switched to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is~     that one treatment group will experience significantly lower costs and/or lower health care~     utilization.~      The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by~     IMS Health, Inc). This claims database includes more than 60 million covered lives. In~     addition to inpatient and outpatient records, this database includes standard and mail-order~     pharmacy claims with paid and charged amounts and dates of service.~      Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these~     retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between~     January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the~     first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will~     be propensity score matched with an oral triptan patient based on the following pre-index~     covariates: age; gender; payer; geographic region; average monthly number of tablets of~     triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department~     visits, and physician visits in the month immediately preceding the index date as well as~     the mean number of hospitalizations, emergency department visits, and physician visits in~     the 5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls~     who had no pharmacy claims for triptans prior to the index date will be analyzed in the~     triptan naïve group, and the SumaRT/Nap patients and their single-entity matched controls~     who switched to a new triptan will be analyzed in the switch analysis.~   "
127895|NCT01381510|"~     Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be~     associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health~     care costs.~      The objective of this retrospective database analysis is to quantify the relationship~     between adherence and length of therapy with a 5ARI and the likelihood of acute urinary~     retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign~     prostatic hyperplasia (BPH). The study will also measure the economic impact associated with~     these medical encounters.~      The MarketScan database contains data from people with commercial health insurance and~     Medicare and includes both medical and pharmacy data that are sourced directly from health~     plans and employers. Approximately 18 million covered lives will be utilized for this study~     in the time period from January 1, 2003 to September 30, 2009.~      This study is a retrospective cohort analysis of medical claims data.~   "
128274|NCT01376518|"~     The aim of the present study is to characterize the influence of an elevated positive~     end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung~     injury on the cerebrovascular autoregulation.~   "
127896|NCT01381497|"~     Migraine headaches lead to absenteeism and can restrict on-the-job productivity~     (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce~     migraine-associated productivity losses and return migraineurs to normal functioning within~     a few hours of treatment.~      This study is an observational, multicenter, parallel-group study of employed patients who~     have been prescribed either a combination product containing sumatriptan and naproxen sodium~     (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will~     report results from 4 migraine attacks per patient. Eligible migraine attacks will be~     defined as those preceded by a 24-hour, headache-free period with onset between 2 hours~     prior to the start of and 4 hours before the end of a scheduled work shift. Data will be~     collected at time of treatment and hourly until the end of the attack or the end of the~     workday. To estimate baseline productivity, data will be collected from 50 randomly selected~     subjects during a migraine-free workday.~      The primary objective of this study is to compare migraine-related, work productivity losses~     (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses~     reported by patients treated with triptan monotherapy. The null hypothesis is that no~     difference will be observed between the number of hours of productivity lost for patients~     who treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks~     with an oral triptan alone. The alternative hypotheses are that patients in either treatment~     group experience significantly fewer hours of lost productivity associated with migraine~     compared to patients in the other treatment group.~      The secondary objectives of this study are to measure the time between treatment and return~     to patient-reported, normal functioning; to evaluate rescue medication use after initial~     treatment; to measure total productivity loss following treatment at hourly time points; and~     to estimate the probability of absenteeism when a migraine begins before or during the~     workday. The null hypotheses for the secondary endpoints are that no differences will be~     observed between the results reported by patients treating with SumaRT/Nap and patients~     treating with triptan monotherapy. The alternative hypotheses are that either treatment is~     superior to the other for each endpoint.~   "
127897|NCT01381484|"~     The purpose of this study is to determine whether La Jolie gel is effective in the treatment~     of periorbital wrinkles.~   "
127898|NCT01381471|"~     The specific aim of this study is to describe 1 year Advair dispensing rates for patients~     with COPD, and to measure the association between Advair adherence and healthcare~     utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk~     of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between~     patients thqat are adherent versus those that are not.~   "
127899|NCT01381458|"~     This retrospective database study will assess differences in the risk of re-hospitalization~     and other COPD-related exacerbations and costs for patients receiving fluticasone~     propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e.~     tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred~     to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the~     treatment of COPD.~      This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.~      Hypotheses for the primary outcome and key secondary outcomes are presented below:~      Specifically the study hypotheses for the primary outcome being tested were:~      Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha:~     There is a difference in risk of COPD-related hospitalization between FSC and AC~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a~     difference in COPD-related costs between FSC and AC~   "
127900|NCT01381445|"~     This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to~     explore the potential for skin thinning in healthy adult volunteers after 42±2 days of~     treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086~     2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or~     clobetasol propionate 0.05% cream.~   "
127901|NCT01381432|"~     This post-marketing surveillance study is to investigate the efficacy and safety of~     azathioprine tablets in subjects whom lung transplantation is performed.~   "
127902|NCT01381419|"~     This study described in the present protocol consists of two sections. Part A is the first~     administration into man to evaluate the safety, tolerability and pharmacokinetics of single~     ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled~     design in healthy male and female (of non-childbearing potential) subjects. Part B will be~     an open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1)~     receptor occupancy by positron emission tomography (PET) scanning with [11C]-GR205171~   "
127903|NCT01381406|"~     This was a retrospective cohort design using administrative claims data from Jan 1, 2003~     through Sep 30, 2007, representing the years of available data, were used for this study.~     Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the~     study period were identified as the target population. An index TIO prescription was defined~     as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004~     to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was~     termed as the index Rx date, and the 1-year period before the index Rx date was termed as~     the pre-index period. The period after the index date was termed as the post-index date, and~     is further divided into a 30-day combination assessment period and a 1-year follow-up~     period. COPD clinical and economic outcomes were measured in a variable length follow up~     period.~      The combination assessment period, defined as the 30-day period following the index Rx date,~     was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone~     propionate/salmeterol xinofoate combination) depending on whether they use FSC in~     combination with TIO during this period. Combination therapy with TIO + FSC was defined as~     having an FSC claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with~     overlapping days supply occurring within 30 days of index Rx date. Enrollees adding FSC for~     the first time after the 30-day combination assessment period were excluded from the sample,~     thus ensuring that the TIO-alone cohort is not using FSC. No outcomes were assessed in the~     30-day combination assessment period. The 1-year period after the end of the 30-day~     combination assessment period was termed as the follow-up period and was used to assess all~     study outcomes. Enrollees were required to be continuously eligible in their health plans~     during the pre-index and post-index periods for a total of 25 months. An intent-to-treat~     approach was used for the analyses. Thus, patients identified to be in a drug therapy cohort~     were considered to be using that therapy during the entire follow-up period, regardless of~     therapy discontinuations.~      Specifically the study hypothesis for the primary outcome being tested was:~      Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO~     cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC~     and TIO cohorts~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between TIO+FSC and TIO cohorts Ha: There~     is a difference in COPD-related costs between TIO+FSC and TIO cohorts~   "
127904|NCT01381393|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance.~   "
127905|NCT01381380|"~     This study is a pain intensity evaluation in patients with myofascial pain submitted~     kinesitherapy after trigger point injection.~   "
127906|NCT01381367|"~     Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and~     exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated~     with morbidity, mortality, and higher health-care cost. In addition, recently high daily~     dose of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in~     moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis~     was worried about by primary physicians. The use of pneumococcal polysaccharide vaccination~     (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from~     previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or~     exacerbations in COPD patients using high daily dose of ICS, the benefit of ICS can be~     preserved and risk of pneumonia can be reduced. However, there is only limited data~     supporting this hypothesis. In this study, the investigators will conduct a double-blinded,~     randomized controlled trial to evaluate the clinical efficacy of PPSV23 in severe COPD~     patients using high daily dose of ICS.~   "
128275|NCT01376505|"~     This phase I trial studies the side effects and best dose of vaccine therapy in treating~     patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined~     with tumor cells may help the body build an effective immune response to kill tumor cells.~   "
127914|NCT01381263|"~     Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in~     children and adolescents. Children and adolescents are reported to have restrictions in~     daily life activities, social contacts, and school attendance, and to have poorer academic~     skills and as well as an increased utilization of heath care services due to pain problems.~     The treatment approaches available today for teenagers with pain are often~     biological/physiological and little evidence for their effectiveness has been shown. It is~     urgent to try new interventions for pain problems in early ages in order to prevent~     disability, development of maladaptive coping strategies and to avoid negative impact on~     daily activities.~      The optimal treatment regime for paediatric pain patients has been suggested to be cognitive~     behavioural approach integrated with physical therapy The aim of this project is to develop~     and evaluate in a randomized controlled trial a treatment program with a behavioural~     medicine approach (suitable to use in primary care or school based health care context)~     compared with standard treatment for adolescents with persistent pain problems. The aim is~     also to compare short and long-term costs for patients and for the health care system~     related to the two interventions, in order to determine strategies for future cost-effective~     care of children and adolescents experiencing recurrent pain.~   "
127915|NCT01381250|"~     A trial testing the outcome of an Internet-based treatment of pathological gambling with the~     hypothesis that there will be improvements both immediately and up to 36 months. It is also~     hypnotized that treatment response can be predicted from background variables.~   "
127916|NCT01381237|"~     Due to the many problems associated with reduced balance and mobility, providing an~     effective and engaging rehabilitation regimen is essential to progress recovery from~     impairments and to help prevent further degradation of motor skills. The purpose was to~     examine effects of physical therapy based on the task-oriented approach delivered in an~     engaging, interactive video game paradigm. The intervention focused on performing targeted~     dynamic tasks, which included reactive balance controls and environmental interaction.~     Thirty community dwelling and ambulatory older adults attending the Day hospital for balance~     and mobility limitation treatment participated in this study. Participants were randomly~     assigned to either a control group or experimental group. The control group received the~     typical rehabilitation program provided at the Day Hospital, consisting of strengthening and~     balance exercises. The experimental group received a program of dynamic balance exercises~     coupled to video game play, using a centre of pressure (COP) position signal as the computer~     mouse. The tasks were performed while standing on a fixed floor surface with progression to~     a compliant sponge pad. Each group received 16 sessions, scheduled two per week, each~     lasting 45 minutes. Balance performance measures and spatial-temporal gait variables were~     obtained pre- and post-treatment Findings demonstrated significant improvements for both~     groups in balance performance scores post-treatment, and change scores were significantly~     greater in the experimental compared to control group. No significant treatment effect was~     observed in either group for the spatial-temporal gait variables. In conclusion dynamic~     balance exercises on fixed and compliant sponge surfaces were feasibly coupled to~     interactive game-based exercise. This in turn resulted in a greater improvement in dynamic~     standing balance control compared to the typical exercise program. However there was no~     transfer of effect to gait function.~      Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games;~     Center of Pressure.~   "
127917|NCT01381224|"~     The purpose of this project is to determine the effect of lower back injections on select~     biomechanical outcomes, walking patterns, lower back flexibility and balance.~   "
127918|NCT01381211|"~     Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for~     an important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors~     are considered resectable at presentation. In contrast to metastatic liver disease, there is~     no role for systemic chemotherapy in the treatment of HCC. Today only evidence is available~     for Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can~     roughly be divided into local ablative, transarterial and systemic therapies. In well~     selected patients, local ablative therapy can offer favorable long term results.~      For patients with disease confined to the liver, but locally more advanced, transarterial~     treatment modalities are proposed. These therapies exploit the dual blood supply to the~     liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver~     parenchyma derives > 75% of its blood supply from the portal vein. Antitumoral agents, such~     as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.~      Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland~     transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads~     (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.~      TACE is currently the gold standard for treatment of patients with intermediate stage HCC,~     with a reported median survival of around 17 months. A novel development in the TACE~     treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials~     reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is~     substantially higher compared to conventional TACE.~      Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which~     implements transarterial administration of minimally embolic microspheres loaded with~     Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.~      In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel~     treatments that both have theoretical and/or proven advantages compared to the use of~     conventional TACE, in patients with intermediate stage HCC.~   "
127919|NCT01381198|"~     The purpose of this study is to evaluate the effects of an additional distal rectus femoris~     transfer carried out as a part of single-event multilevel surgery in children with spastic~     diplegic cerebral palsy.~   "
127920|NCT01381185|"~     The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet~     therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of~     acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA)~     will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin,~     clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of~     clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles)~     will be performed.~   "
127921|NCT01381172|"~     The objective of this investigation is to evaluate the safety and effectiveness of the~     OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.~   "
127922|NCT01381159|"~     The high burden of asthma appears to be related to poor asthma control, which is associated~     with more frequent asthma symptoms, greater bronchodilator use and functional impairment,~     and worse pulmonary function. Despite the availability of effective treatments, more than~     58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS)~     regimens is considered by experts to be one of the most important behavioural factors linked~     to achieving optimal asthma control. However, there is a paucity of research on~     interventions specifically designed to improve ICS adherence among adult asthmatics. The~     vast majority of intervention studies to date used atheoretical interventions to target~     behaviour change, relying mainly upon educational approaches which have been criticised for~     failing to translate knowledge into action. This may be due to the fact that most~     education-based approaches do not specifically address or help patients overcome ambivalence~     about behaviour change, which is necessary for ensuring daily adherence. Motivational~     communication (MC) is a client-centred intervention that focuses on enhancing intrinsic~     motivation to change a particular behaviour, and exploring and resolving ambivalence about~     behaviour change. Brief MC sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to~     improve a variety of health behaviours (e.g., reduce alcohol consumption, improve dietary~     habits, increase exercise behaviour, and improve medication adherence) and health outcomes~     (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to~     date have assessed the efficacy of using MC to improve ICS adherence in asthmatics. This~     study aims to assess the efficacy of using MC to improve daily medication (ICS) adherence in~     a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients~     randomized to the MC condition will exhibit significantly improved ICS adherence at 6 and~     12-months post-intervention, independent of baseline levels and covariates, relative to~     patients randomized to the usual care control condition.~   "
127924|NCT01381133|"~     The purpose of this study was to evaluate the effectiveness and cost-effectiveness of two~     types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320~     adolescents with substance use disorders. Study participants were randomly assigned to one~     of four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b)~     CBOP with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session~     model (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. Based on prior quasi and~     experimental studies, the investigators hypothesized that MET/CBT would be more effective~     and cost-effective than CBOP in terms of increasing days abstinent and decreasing substance~     abuse problems. Additionally, the investigators hypothesized that the groups receiving ACC~     would have significantly better outcomes than the groups without ACC. Lastly, the~     investigators hypothesized that adding ACC to MET/CBT would be the most cost-effective~     option in terms of days abstinent.~   "
127925|NCT01381120|"~     Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents~     are essentially designed to prevent the blockage of the ureter. Such blockage is often a~     result of inflammation caused by ureteroscopy procedures. The stent provides a secure~     passageway for urine as it travels from the kidneys to the bladder, circumventing potential~     urinary retention. In our community, only one kind of stent is used, and it is manufactured~     by Bard. Standard protocol involves the removal of the stent 5 to 8 days following~     insertion. If stenting is required for greater than 8 days, special accommodations will be~     made for you in this study.~      Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion~     and removal of stents. It is our goal to determine whether VESIcare is capable of relieving~     such symptoms.~      As a prospective member of this study, you will be asked to complete three surveys. The~     first survey will ask you about your experiences of urinary urgency and pain before your~     surgery. If you are an emergency patient, you will be asked to remember your condition~     before the surgery, completing this questionnaire at your first post-op visit. If you are~     not an emergency patient, this survey will be completed before your surgery. If your stent~     is removed within 5 to 8 days of surgery, you will be asked to complete the second survey at~     the time of removal. You will then complete the final survey at a scheduled post-operative~     check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after~     surgery, you will be asked to complete the second survey 3 to 4 days after your stent was~     inserted. You will then complete the final survey, 7 to 8 weeks post-op.~      Throughout this study, both VESIcare and non-VESIcare patients will be important in~     determining whether VESIcare truly is capable of relieving stent pain. As such, you will be~     randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.~   "
127926|NCT01381107|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose~     study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with~     buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are~     inadequately/partially responding to current treatment with a stable dose of a~     serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor~     (SNRI).~   "
127927|NCT01381094|"~     The purpose of this study is to evaluate the dose response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with~     repeat dosing for 42 days.~   "
127928|NCT01381081|"~     The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in~     degenerative ones, has not been assessed yet. Current studies on the PRP healing or~     repairing effect on knee cartilage degenerative injuries are not conclusive to establish a~     standard of behavior, although PRP has shown to improve joint functionality and reduce pain.~      Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to~     a more effective and lasting functional recovering than corticosteroid intra-articular~     injections.~   "
127929|NCT01381068|"~     This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the~     delivery room. The use of the monitor is compared with clinical assessment of ventilation.~     The hypothesis is that using the monitor would results in a decrease in the incidence of~     hypo- or hypercapnia on admission to the NICU.~   "
127930|NCT01381055|"~     The purpose of this study is to determine whether pentoxifylline associated to pentavalent~     antimony has a higher cure rate than pentavalent antimony alone in the treatment of~     cutaneous leishmaniasis.~   "
127931|NCT01381042|"~     Previous studies have shown active brown adipose tissue (BAT) is present in adults and may~     play important roles in regulating energy homeostasis. However, the majorities of these~     studies were done in patients undergoing scanning for cancer surveillance, and may not~     reflect BAT behavior in healthy individuals. In addition, little is known about the ethnic~     variation in BAT activity, particularly in Chinese adults. Due to the large amount in our~     cohort, we are able to look at the difference between subjects for cancer surveillance (CS)~     and subjects for medical check-up (MC), and to clarify the impact of clinical and lifestyle~     parameters.~   "
127932|NCT01381029|"~     Investigators in the Division of Infectious Diseases are carrying out a study to determine~     if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza~     vaccination develop an adequate antibody response. The study group will consist of~     individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the~     Seasonal Influenza vaccine.~   "
127933|NCT01381016|"~     The sole purpose of this study is to evaluate pathophysiology of disease. The disease state~     that is being evaluated is the obesity-related alterations in reproductive hormones~        -  The obesity epidemic in the United States is advancing at an accelerated pace. It is~          estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass~          index (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines~          regard obesity as the single greatest health hazard in this century. Female adult~          obesity is associated with menstrual cycle irregularities, ovulatory dysfunction and a~          higher risk of obstetrical complications. This reproductive phenotype of obesity is~          worsened by further increases in BMI and is not solely due to anovulatory infertility.~          While the association of adiposity with subfertility is well documented in population~          studies, the underlying mechanisms remain poorly understood. The main objective of this~          proposal is to clarify the nature of the obesity-related reproductive endocrine~          abnormalities and identify potential etiologies amenable to therapy.~        -  Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol~          negative feedback in obesity.~   "
127946|NCT01380847|"~     The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in~     early protocol biopsies of the renal allograft predicts the progression of fibrosis during~     the first year post-transplantation.~      The investigators will develop a non-invasive approach for predicting fibrosis as a~     substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the~     mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary~     cells from kidney transplant recipients during the first year post-transplantation.~   "
127934|NCT01381003|"~     Chronic Granulomatous Disease (CGD) is a rare inherited disorder in which patients suffer~     from severe infection and inflammation. The first indication of disease usually appears in~     early childhood. The basic defect found to be lie in specialised white blood cells called~     phagocytic cells, which are responsible for engulfing and destroying germs. In CGD, there is~     a defect in an enzyme (known as NADPH-oxidase) that is responsible for generating bleach~     like substances that are important for killing some important germs. In the form of the~     disease known as X-CGD (which accounts for two thirds of patients), there are defined~     mistakes in a gene called gp91-phox, which is a key part of the NADPH-oxidase.~      In many cases, patients can be protected from infection by constant intake of antibiotics.~     However, in others potential life-threatening infections break through. In some cases~     patients also develop serious inflammation requiring high doses of drugs such as steroids.~     CGD can be cured by bone marrow transplant, but the best results are available when there is~     matched donor available. Transplant from unmatched donor have a much worse outcome.~      Gene therapy of CGD can be performed by introducing a normal copy of human gp91-phox gene~     into the blood forming stem cells of patients' bone marrow by using a gene carrier (in this~     study called lentiviral vector). After treatment of the bone marrow cells in a specialised~     laboratory are given back to the patient and will grow into functional phagocytic cells.~   "
127935|NCT01380990|"~     Adenosine Deaminase (ADA) is an enzyme, needed by body to develop lymphocytes of the immune~     system. Children who are born in mutations with mutations in ADA gene have severe combined~     immunodeficiency (SCID). Children with ADA-deficient SCID generally die in the first year of~     life from severe infections because they do not have immune system that can fight against~     infections. ADA deficient individuals can be cured by bone marrow transplant, but the best~     results are obtained when there is fully matched family donor is available. In the absence~     of a matched related donor, transplants from unrelated or mismatched donors have a much~     worse outcome. There is a form of enzyme therapy (PEG-ADA) for ADA-deficient SCID, in which~     children receive injections of purified ADA enzyme 1-2 times each week. These injections can~     allow the immune system to recover to a level that protects children from infections.~      However, these injections have to be given weekly and are very expensive (£ 125,000 -~     200,000 annually) and the recovery of the immune system is not sustained over time.~      Gene therapy for ADA-deficient SCID could be performed by introducing a normal copy of the~     human ADA gene into the blood forming stem cells of the patient's bone marrow by using a new~     type of gene delivery system (in this trial called a lentiviral vector). The gene corrected~     cells are then transplanted back into the patient after small dose of chemotherapy. These~     gene corrected stem cells can survive into the body and make lymphocytes. In this trial, we~     will determine whether gene therapy for ADA-deficient SCID using lentiviral vector is safe,~     feasible and effective~   "
127936|NCT01380977|"~     This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group~     intervention for jail inmates. The hypothesis is that participants in IOC will show~     decreases in criminogenic thinking, decreases in shame, increases in guilt, and increases in~     empathy, which in turn will be reflected in reduced recidivism (official records and self~     report), relative to those randomly assigned to a treatment as usual group.~   "
127937|NCT01380964|"~     The purpose of this study is to identify potential biomarkers for the diagnosis, disease~     progression assessment and response to treatment in patients with Duchenne Muscular~     Dystrophy.~   "
127938|NCT01380951|"~     Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory~     and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is~     considered to be appropriate for the antiviral treatment on CHB patients with liver~     cirrhosis.~   "
127939|NCT01380938|"~     WRITE study aim at identifying the effectiveness of an innovative individualized schedule of~     treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.~   "
127940|NCT01380925|"~     The research team is studying why some African American families have multiple cases of~     breast cancer.~      This study will help to better understand if there are undiscovered genes unique to African~     Americans that may predict early breast cancer risk.~      Breast cancer survivors AND their relatives who are also breast cancer survivors are being~     recruited to the study.~   "
127941|NCT01380912|"~     A randomised double-blinded study, in which the patients either get~     methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the~     efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary~     breast cancer.~   "
127942|NCT01380899|"~     Parkinson's disease (PD) is a degenerative disease that can be difficult to diagnose. The~     clinicopathological studies had demonstrated a 76% accuracy in the clinical diagnosis of PD.~      At the beginning of PD is difficult for the clinician to distinguish from Parkinsonism Plus~     Syndromes (PPS) due to the similarity of symptoms and the lack of specific diagnostic tests.~      Specific biomarkers to help improve the accuracy of diagnosis and to separate these two~     entities are highly needed~      The histological hallmark for definite diagnosis of PD is the presence of fibrillar~     aggregates of phosphorylated alpha-synuclein called Lewy bodies (LBs) and Lewy neurites.~     Previous autopsy-based studies have revealed that alpha-synuclein is deposited in the~     peripheral autonomic nervous system including the enteric nervous system of the alimentary~     tract, cardiac plexus, adrenal medulla and skin.~      For this reason, in patients with parkinsonism, an alternative tool could be to demonstrate~     alpha-synuclein fibrillar aggregates in the skin, allowing early and appropriate diagnosis.~   "
127943|NCT01380886|"~     This is a randomized, multi-center, double blind, parallel study to compare growth and~     tolerance of healthy term infants fed either control or experimental infant formula.~   "
127944|NCT01380873|"~     This trial is conducted to~        1. assess whether SLM0807 alters pharmacodynamics of HKB0701~        2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and~          multiple co-administration of HKB0701/SLM0807 in healthy subject~   "
127945|NCT01380860|"~     The purpose of this study is to compare rates of hernia formation between colostomies~     created with no hernia preventing mesh versus colostomies created with a particular mesh.~   "
127947|NCT01380834|"~     The objective of this study is to assess the efficacy of paravertebral nerve blocks, single~     shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic~     cholecystectomy as compared with incisional administration of same local anesthetic at~     laparoscopic insufflation ports by the surgeon.~   "
127948|NCT01380821|"~     Ionizing radiation has a number of harmful effects in humans. The most important among these~     is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell~     can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks~     (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.~      The investigators are already conducting several other studies to prospectively compare the~     inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending~     these examinations to investigate the induced DSBs by myocardial scintigraphy allows a~     comparison of all three relevant imaging methods of the heart that incorporate ionizing~     radiation.~      To evaluate this, the investigators are planning to examine patients who are scheduled for a~     clinically indicated myocardial scintigraphy. These examinations are routinely done by the~     Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the~     diagnostic reference values of the Federal Department for Radiological Protection. Blood~     samples will be taken from these patients at predefined time steps before and after the~     examination and DNA double-strand breaks will be determined from these blood samples~     specifically considering the applied activity of the tracer and the exposition kinetics.~   "
127949|NCT01380808|"~     The progression free survival could be prolonged adding pseudomonas aeruginosa to~     monotherapy capecitabine.~   "
127950|NCT01380795|"~     The knowledge concerning the biology of the human tumors do not stop widening, in particular~     concerning the molecular mechanisms at the origin of the process of carcinogenesis and its~     ability to become perpetual. The identification and the increasing knowledge of these~     abnormalities allowed during these last years the development of therapeutic strategies~     targeting specifically the molecular pathways involved in the carcinogenesis. It quickly~     lead to numerous therapeutic successes in association with conventional chemotherapy,~     allowing a better individualization of the treatment according to the biological~     characteristics of the tumor of the patient.~      However such therapeutics are effective only if the patients carries specific genomic~     mutations making necessary the systematic research for one kind of mutation.~      The problem is that currently the mutational status is frequently made on the tissue~     resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the~     biology of the metastasis reports a different genomic status, the only theoretical solution~     is then to make biopsy systematically on metastasis, what is not always technically~     possible. The problem still complicates when the investigators know that the biology of the~     tumor may evolve in time, particularly under treatment, with appearance of chemotherapy~     resistant clones. The monitoring of the genomic status of the tumor thus appears to be a~     crucial stake in the next years in cancer research as far as the efficiency of numerous~     therapeutic targeted put at the disposal of the clinician, depends on it largely. The~     repeated access to tumor tissue, during the follow-up of the patient in treatment, seems~     from then on indispensable to guide prematurely the therapeutics, in particular by stopping~     a targeted therapeutics which the investigators know that it is not any more going to be~     effective, and so avoiding exposing the patient to useless toxicity of a treatment often~     extremely expensive, and of which usage should have to be reserved to patient who could~     respond to it.~      The access to the circulating tumor cells in the blood of patients is a repeatable, not~     invasive technique (blood test) and henceforth accessible thanks to a technique using a~     magnetic sorting of the tumor cells selected by an antibody directed against the tumor~     antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and~     automated, allows from a total sample of blood of the patient, to determine the quantity of~     circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a~     powerful prognosis tool at the moment diagnosis, but also during treatment, according to its~     decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA)~     recently approved the use of this system for the quantification of the CTCs in the care of~     the patients affected by breast, colon, and prostate cancer. The CellSearch system will~     probably become in the future years an indispensable tool to help the clinicians to encircle~     better the prognosis of their patient. This technology already allows to realize besides a~     quantification, the isolation of viable CTCs, from which the genetic material can be~     extracted, amplified thus potentially analyzed. The investigators thus see all the interest~     which such a device can represent in the non invasive monitoring of the patients under~     treatment targeting molecular abnormality susceptible to evolve in time. The investigators~     thus propose to study thanks to the system CellSearch the feasibility of the research for~     the mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small~     cells bronchial carcinoma.~      Secondly, the investigators research will be interested in the possible conflicts existing~     between the primitive tumor and the CTCs for the various popular mutations. In case of~     feasibility of the method, and the good initial concordance between the genomic status of~     the CTCs and that of the tumor, the investigators shall describe the genomic evolution under~     treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators~     shall describe then if the premature observation of modification precedes the appearance of~     an effective resistance in treatments.~   "
127951|NCT01380782|"~     BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally.~     This drug is currently being used in treatment for other cancers in research studies and~     information from those other research studies suggests that this agent, BIBF 1120, may help~     to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth~     of new blood vessels at the site of the tumor. In this research study, the investigators are~     looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.~   "
127952|NCT01380769|"~     The purpose of this study is to compare median overall survival of patients with advanced~     non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best~     supportive care (BSC).~   "
127953|NCT01380756|"~     This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion.~     The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK~     (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93~     subjects may be enrolled in dose escalation. The dose expansion part of the study will~     consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent~     upon data from the dose escalation part of the study.~   "
127954|NCT01380743|"~     This study will look at Drug-Drug Interactions Between AT2220 (duvoglustat hydrochloride)~     and alglucosidase alfa (ERT) in Patients with Pompe Disease.~   "
127955|NCT01380730|"~     To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered~     every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from~     baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.~   "
127956|NCT01380717|"~     Patients with reduced kidney function have a higher risk of heart disease and death. Studies~     have shown that blood vessels in patients with hypertension change with a decrease of lumen~     size and growth of the vessel wall. By treating patients with antihypertensive certain~     medication vessel lumen and walls normalize. Treating hypertension in patients with chronic~     kidney disease slows the progression of kidney function loss.~      The aim is to compare different degrees of antihypertensive medication in patients with~     chronic kidney disease and hypertension will slow the progression of kidney loss.~   "
127957|NCT01380704|"~     This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically~     healthy subjects with mild to moderate depressive symptoms who are not taking any~     antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of~     this study.~   "
127958|NCT01380691|"~     This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684~     with Alcohol in Healthy Subjects. This study will run approximately for 34 days.~   "
127959|NCT01380678|"~     The purpose of this study is to evaluate that intralesional injection of bevacizumab on~     primary pterygium can reduce the corneal pterygium area, inflammation, redness and other~     symptoms.~   "
127960|NCT01380665|"~     The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when~     applied to either the hip or knee area over a surgical cut for the time you are~     hospitalized.~   "
127961|NCT01380652|"~     The aim of this study is to investigate the change of physical activity in COPD-patients~     performing a whole body vibration training additional to a standard three-week~     rehabilitation program in comparison to patients performing merely a standard rehabilitation~     program.~   "
127962|NCT01380639|"~     The aim of this study is to investigate the exercise capacity in COPD-patients performing a~     vibration training additional to a standard three-week rehabilitation program in comparison~     to patients performing merely a rehabilitation program.~   "
127963|NCT01380626|"~     Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and~     Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation~     in regard to improvement of 6-minute-walking distance. The aim of this study is to~     investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency~     patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with~     strength and endurance training. In addition to conventional diagnostic procedures, muscle~     biopsies from the M. vastus lateralis will be conducted before and after rehabilitation~     program followed by biochemical, histochemical and immunohistochemical analysis of the~     probes.~   "
127964|NCT01380613|"~     The goal of this study is to examine how social networks, neighborhood, and depression are~     related to HIV risk. The intervention is designed to train individuals to cope with feelings~     of depression or stress as a way to reduce their risk for HIV.~   "
127965|NCT01380600|"~     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594~     (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are~     refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.~   "
127966|NCT01380587|"~     The purpose of the study is to determine the utility of XCL1 in the prognosis of acute~     lymphoblastic leukemia.~   "
127967|NCT01380574|"~     The purpose of this study is to investigate the complications of cardioversion of acute (<48~     hours duration) atrial fibrillation (AF).~      Primary Outcome Measures:~      - Incidence and predictors of thromboembolic complications, especially stroke, and death <31~     days after cardioversion of acute AF~      Secondary Outcome Measures:~        -  Number of therapy non-responder and early recurrence of AF~        -  Bleeding complications during the 31 days follow-up~        -  Hemodynamic complications of cardioversion~      Estimated Enrollment: 3000 cases~      Study Start Date: Jun 2011~      Estimated Study Completion Date: December 2011~   "
127968|NCT01380561|"~     This is an open label, single center, metabolite identification, mass balance, and PK study~     in healthy male volunteers.~   "
127969|NCT01380548|"~     This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in~     subjects with iron deficiency anemia.~   "
127970|NCT01380535|"~     The purpose of this study is to evaluate the safety and effectiveness of extracorporeal~     photopheresis therapy when added to standard drug therapies administered to patients with~     moderate to severe chronic graft-versus-host disease.~   "
127971|NCT01380522|"~     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.~     Searle, Inc.~   "
127972|NCT01380509|"~     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.~     Searle, Inc.~   "
127973|NCT01380496|"~     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen~     doxycycline monohydrate 100 mg.~   "
127974|NCT01380483|"~     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen~     doxycycline monohydrate, 100 mg.~   "
127975|NCT01380470|"~     The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive~     Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region~     of Murcia~   "
127976|NCT01380457|"~     The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10~     mg capsules verses Marinol.~   "
127977|NCT01380444|"~     The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus~     sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52~     weeks in individuals with trochanteric fractures. Secondary outcomes include revision~     surgery rates, fracture healing rates, fracture related adverse events, and health-related~     quality of life, including the Parker mobility score and Harris Hip Score.~   "
127978|NCT01380431|"~     The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets~     and IPR Pharmaceuticals, Inc. Zestril (R).~   "
127979|NCT01380418|"~     Some overweight individuals develop problems with their breathing such that they gradually~     breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the~     blood, called ventilatory failure. As a consequence, if such a person develops a chest~     infection, they are more likely to become seriously ill and need intensive care. In addition~     they are much more likely to develop severe complications during and following operations.~     This problem can be treated with a machine at home used overnight to help breathing. It is~     interesting that ventilatory failure only happens in some overweight individuals, and the~     investigators do not understand what factors make this complication develop. There are a~     number of theories: for example the distribution of the fat, additional lung disease (such~     as asthma), the addition of obstructive sleep apnoea, a condition when there are periods of~     cessation of breathing overnight (which is more common in obese individuals), weak muscles~     of breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and~     other hormonal changes.~      The investigators intend to measure many potential factors in a range of overweight~     individuals, some who have ventilatory failure, and some who do not, to try and work out~     which are the important factors that cause this problem. If the investigators can identify~     such factors, then this will help predict in advance who is at risk from chest infections~     and during operations; thus allowing for earlier provision of an overnight breathing~     machine. This should reduce complications and potentially deaths in such individuals.~   "
127980|NCT01380405|"~     Given the importance of the correct use of inhalers by patients with Chronic Obstructive~     Pulmonary Disease (COPD) for the appropriate treatment of the disease, the self-care~     programme which will be assessed will consist of an educational intervention on the correct~     use of inhalers.~      For this aim, we have designed this study to assess the influence of both individualized and~     collective self care programmes about the correct use of inhalers improves the functional~     state of patients with COPD compared to when there is no educational intervention.~   "
127981|NCT01380392|"~     The aims of this study are to (1) understand the uncertainty , personality and coping~     strategies in patients with HCC, and identify the significant factors for coping.~   "
127982|NCT01380379|"~     Previous research has shown that self-defense training can lead to gains in women's~     assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in~     anxiety, helplessness, fear, and avoidant behaviors. However, most of this research has been~     conducted with healthy women who had not previously experienced physical or sexual violence.~     The investigators believe that women with such trauma histories require additional care~     because of potential triggering symptoms. As such, the investigators are mindful of the~     potential for triggering trauma symptoms and will work with the women so that they feel safe~     and comfortable in their participation. This pilot study aims to examine whether similar~     psychological gains from self-defense training are made in women who have previous~     experiences of physical and/or sexual violence.~   "
127983|NCT01380366|"~     Patients who are being asked to participate in this study have a short small bowel and will~     be prescribed to take the medication: Zorbtive® (Zorbtive/Somatropin/(rHGH)). Zorbtive® is~     an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if~     taking this medication improves small bowel function by helping it to take in food,~     nutrients, vitamins and minerals. The investigators also believe that if the small bowel is~     absorbing food and nutrients better, liver function will improve as well. Therefore, liver~     function will also be monitored during the course of the study by performing blood tests.~   "
128084|NCT01379027|"~     Evidence-based treatments (EBTs) for mental health conditions are often not available to~     persons needing them in the community. Our aim is to test a novel Internet intervention that~     has the promise of eventually improving the Reach and Implementation of mental health EBTs,~     speeding the translation of research successes into improved community care.~   "
127984|NCT01380353|"~     The purpose of this study is to look for ways to improve breast cancer treatment by giving~     breast cancer drugs through the skin of the breast.~      The drug used in this study is a diclofenac epolamine patch and is a nonsteroid~     anti-inflammatory pain reliever. The drug amount that gathers in the breast, after~     application of a patch to the skin of the breast, will be measured and compared to the~     amount that is found in the breast when the patch is applied to the skin of the belly.~   "
127985|NCT01380340|"~     This study will investigate the effects of a new form of early intervention for senior~     drivers who are at risk of changes to their driving status. The early intervention consists~     of group activities involving planning and professionally facilitated discussion.~      There are three main research hypotheses for this study. Firstly, it is hypothesised that~     early intervention, in the form of the information and planning group, will not be~     associated with either increases or decreases in driving assessment failure or driving~     cessation. Secondly, it is hypothesised that early intervention will be associated with~     patterns of reduced depression and less persistent negative mood states. Thirdly, it is~     hypothesised that early intervention will be associated with patterns of sustained levels of~     important quality of life indicators such as community participation and social~     relationships.~   "
127986|NCT01380327|"~     This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is~     designed to study biomarkers of the immune response to allergen immunotherapy and the safety~     of this therapy in a pediatric population.~   "
127987|NCT01380314|"~     Cutaneous leishmaniasis is endemic in the New World from approximately the US-Mexican border~     through Central America and the Northern part of South America down to the level of Rio de~     Janeiro.~      Until recently, the standard treatment for the leishmaniases was pentavalent antimony~     (Glucantime or Pentostam). The cure rate for L panamensis in Colombia is 91%-93% [Soto,~     1993; Velez, 1997], a large study with several formulations of antimony found a combined~     Bolivia-Colombia cure rate of 86% [Soto, 2004b], and in work just completed, the cure rate~     in Palos Blancos, Bolivia is 15 of 16 = 94% [ Soto, manuscript in preparation].~     Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and~     mild-moderate clinical toxicity [gastrointestinal complaints, liver enzyme elevations,~     pancreatic enzyme elevations], all of which are particularly unpleasant for a moderate~     clinical problem such as cutaneous leishmaniasis.~      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and~     Bolivia. In Colombia, the cure rate for miltefosine was 91% [Soto 2004a] and in the~     just-completed trial in Palos Blancos, the cure rate for miltefosine was 32 of 37 = 88 % .~     Side effects seen in patients with cutaneous disease that can be specifically attributed to~     the drug are nausea and vomiting of mild grade in approximately 25% of patients, and~     low-grade elevation of creatinine also in approximately 25% of patients [Soto 2001; Soto~     2004].~      The 6-month cure rate did not reach 100%, and miltefosine was relatively slow to cure~     compared to Sb. 31 of 44 evaluable miltefosine patients (70%) were cured by 1 month after~     therapy, compared to 16 of 16 evaluable Glucantime patients (100%).~      Imiquimod (Aldara; 3M Pharmaceuticals) is a novel immune response-activating compound,~     approved by the FDA for cervical warts, that activates macrophage killing of Leishmania~     species. Combined imiquimod plus Glucantime was used as rescue treatment in 12 patients with~     Peruvian cutaneous leishmaniasis who had previously not responded to Glucantime alone. 90%~     of patients were cured at the 6-month follow-up period [Arevalo, 2001]. In a follow up study~     [Miranda-Verastegui et al, 2005], naïve patients were randomized between the combination of~     Sb plus imiquimod (18 patients) vs Sb plus placebo (20 patients). The cure rate at 1 month~     after therapy was 50% in the imiquimod +Sb group compared to 15% in the placebo+Sb group (p~     = 0.02). By 12 months after therapy, the Sb+placebo group had caught up, and the cure rate~     was 72%-75% in each group. Local side effects were evaluated. Edema, itching, burning, pain~     were equal in the two groups. There was more erythema in the imiquimod grup (55% of~     patients) compared to the placebo group (25% of patients).~      The Imiquimod studies in neighboring Peru suggest that combination with this immunomodulator~     is capable of decreasing the time to cure, and potentially increasing the cure rate, in~     Andean cutaneous leishmaniasis. The present study will evaluate the combination of oral~     miltefosine plus topical imiquimod for cutaneous leishmaniasis in Bolivia. If in the first~     group of patients, cure rate at 1 month after therapy is appreciably above the 70% historic~     value for miltefosine alone and the cure rate at 6 months is greater than the 88% historic~     value for miltefosine alone, subsequent patients will be randomized between~     miltefosine+imiquimod and miltefosine+placebo cream.~   "
127988|NCT01380301|"~     Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard~     treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93%~     and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the~     disadvantages of multiple injections and mild-moderate clinical toxicity all of which are~     particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.~      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and~     Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that~     can be specifically attributed to the drug are nausea and vomiting of mild grade in~     approximately 25% of patients, and low-grade elevation of creatinine also in approximately~     25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks~     have not been evaluated for cutaneous disease.~      Combination therapy is now being used for many infectious diseases, such as tuberculosis,~     malaria, and HIV. Combination therapy offers the potential of preventing drug resistance,~     because organisms resistant to one of the drugs may be susceptible to the other drug; and~     also the potential to diminish drug therapy duration and thus side effects. These two~     potential benefits to some extent contradict each other: preventing resistance is best done~     if full courses of both drugs is used; diminishing therapy duration means using less than~     the full course of each drug. The optimum combination regimen is one in which sufficient~     amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible~     to spare patients unnecessarily long courses of drug.~      In the present protocol, the combination of a half-course of miltefosine and a half-course~     of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and~     antimony is chosen because these are now the two standard agents in Bolivia, and in vitro~     the combination was additive to mildly synergistic against a standard leishmania strain.~   "
127989|NCT01380288|"~     The purpose of this study is to evaluate and compare the changes of cognitive function (as~     measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated~     with and without white matter changes after rivastigmine patch therapy.~   "
127990|NCT01380275|"~     The purpose of this study is to estimate the control rate (CR,PR,SD) of docetaxel and~     irinotecan (DI) combination chemotherapy for recurrent or refractory bone and soft tissue~     sarcomas.Al so, this study is to evaluate the toxicity profile of Docetaxel and Irinotecan~     (DI) combination chemotherapy.~   "
127991|NCT01380262|"~     Up to 60% of patients with metastatic colorectal cancer can be treated with one of~     monoclonal antibodies targeted against epidermal growth factor receptor (EGFR). This~     treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up~     to erythema, often with severe pruritus, sometimes combined with other types of skin~     toxicities (hair and nail changes). Previously in STEPP study investigators shown that~     pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun~     blockers reduces the number of more severe skin side effects of panitumumab.~      The study is designed to described the profile of skin toxicity of EGFR blocking drugs~     combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.~   "
127992|NCT01380249|"~     This phase I study in adult patients with advanced solid tumours is designed to evaluate~     toxicity, drug exposure (pharmacokinetics) and drug action (pharmacodynamics) of a new~     molecule, PDM08, administered twice a week cycles of 4 weeks. This drug has shown~     antitumoral activity in several murine cancer models.~   "
127993|NCT01380236|"~     The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when~     given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe~     asthma.~   "
127994|NCT01380223|"~     This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil~     infusion in healthy male volunteers.~   "
127995|NCT01379443|"~     The objective of the study is to compare the usual care and treatment of children and youth~     (0-19 years) with multiple developmental delays and disabilities and their families in~     Simcoe York with a co-ordinated, navigated approach to care using the Children's Treatment~     Network (CTN) services.~   "
127996|NCT01379430|"~     The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and~     MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The~     regime proposed in this trial has protected non-immune volunteers against sporozoite~     challenge in clinical trials performed by Oxford, and so may be protective against naturally~     acquired infection in Kenya.The study population will comprise 30 healthy adult males aged~     18-50.~      The investigators do not propose to include a placebo group. At this stage the investigators~     objective is to describe the safety profile in a small number of individuals, and the~     confidence intervals for the proportion of individuals with a particular event would be too~     wide for meaningful comparison with a placebo group. Immunogenicity will be judged by~     comparison with baseline.~   "
127997|NCT01379417|"~     The main objective is to assess the nutritional benefit of probiotics supplementation on~     premature infants growth. As secondary objectives, different parameters related to~     probiotics tolerance will be measured.~   "
128111|NCT01378676|"~     The study will generate data on safety and tolerability after multiple daily doses of~     CK-2017357 in patients with ALS. Patients will be randomized into one of four different~     treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of~     CK-2017357 for 14 days.~   "
128353|NCT01375478|"~     This open-label, retrospective, observational study will evaluate the compliance to~     RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid~     arthritis. Six months data will be collected from patients records.~   "
127998|NCT01379404|"~     Patients with severe infections initially require large amounts of fluid as part of~     resuscitation. Later on however, problems may arise from excess fluid such as increased time~     on a ventilator and kidney damage. The amount of fluid a patient has is difficult to assess.~     One approach is to determine the amount of fluid that is present in a large central vein.~     This can be done by physical examination of the jugular veins, or by placing a catheter~     within the vein. Unfortunately this method is unreliable and does not predict the amount of~     fluid a patient has.~      Bioimpedance analysis (BIA), is a device that can determine the amount of fluid in the body~     by measuring the body's electrical properties. It is a quick and painless test that assesses~     volume. The primary objective of this study is to determine if BIA measurements are~     associated with patient important outcomes such as time on a ventilator, risk of kidney~     failure requiring dialysis and death. We will also determine whether BIA is a measure of~     fluid status in ICU patients. This study will assess feasibility in establishing a~     multi-centre study assessing if BIA's role in predicting adverse outcomes and thereby~     prognosis and fluid status. We hypothesize that shorter vector lengths will be associated~     with hypervolemia and less ventilator free days.~   "
127999|NCT01379391|"~     Factors influencing platelet engraftment after allogeneic hematopoietic stem cell~     transplantation (Allo-HSCT) includes previous chemotherapy courses, conditioning regimen,~     HLA compatibility, source of stem cell, CD34+ cell count, infection of~     virus/bacteria/fungal, graft-versus-host disease (GVHD), etc. Large-scaled clinical trials~     have demonstrated that platelet count below 20G/L on 14 days after transplantation is an~     predictive factor for delayed platelet engraftment, which lead to increased platelet~     infusion requirement and high risk of bleeding. Multivariable survival analysis indicated~     that delayed platelet engraftment in Allo-HSCT is independent predictive factor for~     transplantation related mortality (TRM). But effective treatment approaches for delayed~     platelet recovery after Allo-HSCT are still lacking now.~      Recombinant human thrombopoietin (rHuTPO) is a fully modified recombinant human~     thrombopoietin accurately expressed in mammalian cells. The rHuTPO agent manufactured by the~     3Bio Pharmaceutical Limited Liability Company (LLC) in Shenyang is approved by the State~     Food and Drug Administration (SFDA) of China in 2005 and is the first rHuTPO agent available~     globally. RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related~     thrombocytopenia in China. Animal experiments showed that TPO-mobilizing stem cell could~     promote platelet engraftment in Allo-HSCT in mice. As for efficacy and safety of TPO on~     platelet engraftment after Allo-HSCT, it's marginally addressed in clinical trials.~      Based on preliminary research results, investigator designed a phase IV, open-label,~     prospective, multicenter Study of the efficacy and safety of recombinant human~     thrombopoietin injection (rHuTPO, TPIAO)on platelet engraftment in Allo-HSCT in China.~   "
128000|NCT01379378|"~     The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier~     to sexual satisfaction/frequency/desire and if surgical correction of incontinence will~     improve these aspects of sexual health.~   "
128001|NCT01379365|"~     This is a prospective, non-randomized study to evaluate the performance of the MyoScience~     Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.~   "
128002|NCT01379352|"~     The vecuronium requirements may be reduced for recipients of living donor liver~     transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the~     requirements may be different according to the phase of surgery. The requirements may also~     be different according to the preoperative hepatic function as measured by MELD score during~     prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase.~     Therefore, the investigators are trying to investigate the difference of vecuronium~     requirements according to the phase of surgery or MELD score, GRWR.~   "
128003|NCT01379339|"~     The primary objective of this study is to determine the first-cycle maximum tolerated dose~     (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and~     Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma~     of the head and neck for three cycles.~   "
128004|NCT01379326|"~     Objectives:~      The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted~     Helminths (STH).~      The primary objective is:~      (1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against~     Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR)~     and Cure Rate (CR).~      The secondary objectives are:~        1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.~        2. to assess the occurrence of β-tubulin mutations related to resistance before and after~          drug administration.~        3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.~   "
128005|NCT01379313|"~     In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the~     disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal~     pressure. The investigators tried to evaluate the effect of various inspiratory to~     expiratory ratio on pulmonary gas exchange by randomized controlled trial.~   "
128006|NCT01379300|"~     This is a study to investigate biomarkers after single oral doses of the anticoagulant~     agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy~     elderly subjects.~   "
128007|NCT01379287|"~     Iso-fludelone is a type of chemotherapy drug called an epothilone. Epothilones are drugs~     that attach to proteins in your body called tubulins. Tubulins help cells to grow, and are~     found in both normal and cancer cells. When research animals with cancer were given the~     study drug, Iso-fludelone, the drug attached itself to tubulin and slowed or stopped the~     cancer cells from growing. Other types of epothilones have been tested in cancer patients~     and were found to be safe. A similar epothilone drug and other drugs called taxanes are~     currently approved by the FDA for treating certain types of cancers.~      The purpose of this study is to see the effects, good and/or bad, of this investigational~     drug, Iso-fludelone, on cancer. The term investigational means the study drug being tested~     has not been approved by the United States Food and Drug Administration (FDA) or other~     regulatory agencies. This study is the first time the investigators are using iso-fludelone~     in people. This is a Phase I study. In a Phase I study, the first people to receive the drug~     are given a fairly low dose.~   "
128123|NCT01378520|"~     Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter~     the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases~     blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce~     ratings of breathlessness induced by resistive breathing loads.~   "
128008|NCT01379274|"~     This phase II study will evaluate the safety and efficacy of combining two active~     agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of~     patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale~     for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination~     therapy will result in higher response rates, and potentially longer response duration than~     that achieved with either agent.~      STUDY OBJECTIVES:~      Primary:~      To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and~     low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q~     deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy~      Secondary:~      To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q~     deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza®~     (azacitidine), as defined by the IWG 2006 Revised Response Criteria~   "
128009|NCT01379261|"~     The purpose of this study is to determine whether treatment of patients suffering from~     ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous~     catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous~     coronary intervention (PCI) result in a reduction in infarct size.~   "
128010|NCT01379248|"~     The purpose of this study is to examine the benefit of thrombus aspiration in patients with~     ST-elevation myocardial infarction presenting late after symptom onset.~   "
128011|NCT01379235|"~     Background: The elderly population in western countries and in Israel is constantly growing.~     Falls are one of the common problems among this population. Thus there is a need for falls~     prevention exercise program to be offered in the different settings elderly reside. Most~     methods for physical exercise are dedicated to muscle strengthening and improving balance by~     strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the~     in-depth muscles. The advantage of this method is in its simplicity and availability. This~     method is suitable also for special populations as patients in acute hospitalization. In~     this study, the investigators will evaluate if the pilatis exercise can improve balance of~     elderly population. Physical exercise usually improves the mood. Like any physical exercise,~     Pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis~     exercise can improve quality of life of elderly population.~      Working hypothesis and aims: Pilatis exercise will improve balance and stability~     measurements, and quality of life among elderly population.~      Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to~     Clalit Health Services primary care clinic . Participants of the intervention and control~     group will receive a brochure that will include nutrition and healthy life style~     recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a~     week. The control group will be offered the same intervention at the end of the study~     period. Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg~     Balance Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36~     questionnaire will be use to evaluate quality of life.~      Importance: This study will examine the influence of pilatis exercise on balance among the~     elderly. If findings will determine that pilatis does improve balance in the elderly, the~     investigators can further examine pilatis's influence on falls prevention, and minimizing~     falls damages.~      Probable implications to the welfare and health of the aged population:~      Improving balance, falls preventing and minimizing falls damages among elderly; improvement~     in elderly quality of life.~   "
128012|NCT01379222|"~     The purpose of the study is to demonstrate the long term safety and effectiveness of the~     Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic~     aneurysms in a post-approval environment, through the endpoints established in this~     protocol.~      The clinical objective of the study is to evaluate the long term safety and effectiveness of~     the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related~     Mortality (ARM).~   "
128013|NCT01379209|"~     The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to~     evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients~     undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.~      The study will be separated into two parts; a dose escalation phase to assess safety,~     followed by a large expansion phase to further evaluate the pharmacologic effects of either~     a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of~     RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include~     higher risk patients and limit the unrelated donor transplants. After safety is established~     in part 1 of the study, the second portion of the study will expand the enrollment criteria~     and allow transplantation by either related or unrelated donors.~      This study will endeavor to identify the dose range at which RGI-2001 has an acceptable~     safety profile, at which biologic activity is observed, and to guide possible dose levels to~     utilize in later phase studies based on biological activity.~   "
128014|NCT01379196|"~     The purpose of this study is to examine the effects of Azithromycin (a macrolide class~     antibiotic), given three times weekly, for patients with active moderate-severe, non~     sight-threatening, Graves Orbitopathy.~      Indices for follow-up will include:~        -  Clinical activity score~        -  Anti-TSH receptor antibody levels~        -  Thickening of extraocular muscles per ultrasound~        -  Quality of life score for Graves Orbitopathy patients~   "
128015|NCT01379183|"~     Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected~     small bowel disease. This technique depends, in part, on adequate distension of the small~     bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast~     material prior to the examination, which typically produces excellent distension of the~     distal small bowel and stomach, but poor distension of the proximal small bowel.~     Erythromycin is a common antibiotic that is known to promote stomach emptying and is used to~     treat diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was~     that erythromycin will increase gastric emptying and hence improve small and large~     intestinal distention during MRI.~   "
128025|NCT01380106|"~     This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in~     combination with low dose dexamethasone in patients with relapsed multiple myeloma.~      The investigators propose to use the need for dose reduction as a criterion to judge~     tolerability from various causes. In the veteran population which predominantly is in the~     older age category with number of co-morbidities, a lower dose regimen may be safer and~     advantageous.~      This study expects to enroll approximately 80 subjects from participating VA sites across~     the nation.~      The investigators will evaluate the safety of the two dose regimens by comparing frequency~     of dose reductions. The investigators will also measure how long the responses last with~     each dose.~      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of~     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for~     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM~     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In~     this case it is considered experimental.~      At the time of enrollment, one-half of the subjects will be chosen at random to receive the~     15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide.~     Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d.~     or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will~     be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose~     reduction on the same schedule if the patient cannot tolerate the higher dose of~     dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis.~     Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended.~     Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.~   "
128016|NCT01379170|"~     Background of the study:~      Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight~     loss, which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone~     treatment stimulates energy expenditure resulting in increased body heat production, in~     which brown adipose tissue play an important role. It is hypothesized that thyroid hormones~     would induce increased energy expenditure via a process called mitochondrial uncoupling,~     thereby creating an inefficient energy status. Indeed, an in vivo study showed a 70%~     increased flux through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis~     rate upon T3 treatment in lean, healthy young men. The disproportionate increase in TCA flux~     compared with ATP synthesis suggests increased mitochondrial uncoupling. It is however~     unknown whether increased mitochondrial uncoupling would increase fat oxidation and exerts~     favorable effects on insulin sensitivity. There is compelling evidence that type 2 diabetic~     patients have high levels of fat accumulation in non-adipose tissues, such as skeletal~     muscle, heart and liver. Ectopic fat accumulation is related to insulin resistance, however,~     why this fat accumulates in peripheral organs is not known. Recently, studies reported~     compromised mitochondrial oxidative capacity in type 2 diabetic patients and first-degree~     relatives of diabetic patients, suggested to play an important role. Therefore, subjects~     suffering from overweight and/or type 2 diabetes with overt hypothyroidism form an~     interesting group for examining the metabolic effects of thyroid hormone treatment, as less~     is known about the effects of thyroid hormone treatment in these groups.~      Objective of the study:~      The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type~     2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial~     function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue~     activity and enhance insulin sensitivity.~      Study design:~      Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid~     hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be~     metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral~     tissues) before and after this thyroid hormone replacement therapy.~      Study population:~      17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8~     from Germany which will only do the PET-CT)~      Primary study parameters/outcome of the study:~      Thyroid hormone-induced change in whole body insulin sensitivity (change in~     insulin-stimulated glucose disposal) and muscle mitochondrial function.~      Secondary study parameters/outcome of the study (if applicable):~      Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown~     adipose tissue activity.~   "
128017|NCT01380210|"~     Carbon dioxide intoxication is a rare condition and only few case reports are found in the~     literature. There were six patients who suffered from carbon dioxide intoxication in our~     hospital about two years ago. Two of them are more severe with conscious change and brain~     MRI studies of the two patients were performed. Reviewing the literature, no any report has~     mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to~     review the brain lesions on the diffusion weighted images and the laboratory data of the~     patients for further diagnostic help.~   "
128018|NCT01380197|"~     The pathophysiology of sickle cell disease (SCD) manifestations, are complex with~     interactions of intracellular hemoglobin, membrane and endothelial activation but the~     hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes~     are thought to result from ischemia caused when small blood vessels are occluded by~     misshapen, inflexible erythrocytes. Painful episodes are the most common cause of~     hospitalization, morbidity, and impairment for SCD patients. There is no therapy that~     completely prevents or directly aborts painful events for all patients. Consequently,~     treatment for acute VOC is primarily supportive using hydration and medicinal pain control.~     Every pain medication has the potential to relieve pain but is associated with significant~     limitations and side effects.~      The primary hypothesis to be tested in this double blind, randomized controlled trial is~     that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer~     episodes of acute chest syndrome. The investigators also expect subjects will report fewer~     side effects from respiratory depression, abdominal distention from reduced peristalsis,~     reduced histamine release causing pruritis and still be provided adequate pain control.~     Further hypotheses to be tested is ability to recruit patient participants while being~     treated in the Emergency Department and that continuous infusion of Nalbuphine with~     accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain,~     requiring less total opiates consumption, while decreasing length of hospitalization.~   "
128019|NCT01380184|"~     Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of~     ridaforolimus after administration of single and multiple 40 mg doses in Chinese~     participants with advanced cancer. Part 2 of the study is optional; participants can~     continue to receive the study drug in a weekly regimen of daily oral doses of ridaforolimus~     40 mg for 5 consecutive days followed by 2 days off-drug.~   "
128020|NCT01380171|"~     Children who are born with cleft palate need surgery in order to correct the problem. The~     surgery is needed because the defect allows food to leak into the nose. It also causes the~     patient to be unable to speak correctly, producing a problematic nasal sound. Sometimes the~     first surgery does not completely correct the problem and a second surgery is needed.~     Looking at the records of patients who have had corrective surgeries done in the past would~     allow the surgeons to improve their success rate and reduce the need for secondary~     surgeries. It would also create greater patient safety and reduce cost for families.~   "
128021|NCT01380158|"~     The primary objective of this study, is to determine the effect of a Cup pessary, a device~     that is currently readily available in the USA and similar in design to the Arabin pessary,~     on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous~     birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length~     prior to 23 weeks.~   "
128022|NCT01380145|"~     This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the~     immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple~     myeloma who had completed induction therapy with at least a Very Good Partial Response~     (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for~     high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary~     objective was to determine the safety and tolerability of immunizations when administered~     prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary~     objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of~     immunization.~   "
128023|NCT01380132|"~     The purpose of this study is to determine whether anorectal application of Nasha Dx is safe~     and effective for treatment of anal incontinence.~   "
128024|NCT01380119|"~     This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic~     benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT)~     among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will~     be compared to placebo combined with standard ATT therapy. The trial will consist of one~     stage with sputum evaluation at months 1 and 2.~   "
128026|NCT01380093|"~     The primary purpose of this study is to determine the abuse potential of EMBEDA compared to~     controlled release morphine when crushed and taken orally by non-dependent recreational~     opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA~     relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA~     with crushed controlled-release morphine and crushed placebo.~   "
128027|NCT01380080|"~     People with HIV have a high chance of becoming infected with TB, especially when they live~     in areas where TB infection is common. It can be difficult to diagnose TB in people who need~     to start HIV treatment right away. Within about 6 months after starting HIV treatment, some~     of these people can become very sick with TB and can even die from it.~      This study is being done in people who are starting HIV treatment and who live in areas~     where the TB infection rate is high. The purpose of this study is to test an experimental~     approach to TB treatment to see if it is better than the usual approach. The experimental~     approach is to start TB treatment at the same time as HIV treatment, even when TB infection~     has not been found. The usual approach is to start TB treatment only if TB infection is~     found.~      In this study, half of the people will start TB treatment at the same time as they start~     their HIV treatment. The other half will start TB treatment only if TB infection is found.~      The study will also test how safe and effective it is to start TB treatment at about the~     same time as HIV treatment even when TB infection has not been found. The study will collect~     information about diet, whether (and when) people in the study become sicker or die, how~     well their HIV is controlled, how they are feeling, how they are taking their medications,~     whether it matters where they live or what kind of HIV and TB care is standard, how many~     people are diagnosed with TB while in the study, and how the cost of the two treatment~     options on a national level could be compared.~   "
128028|NCT01380067|"~     laparoscopic hernia sac high-ligation~        -  has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral~          umbilicus ligament covering the hernia opening~        -  The investigators developed a method of laparoscopic hernia repair by applying a new~          concept in hernia repair. The hernia opening was tightened, and hernia opening region~          repaired with a lateral umbilicus ligament in a tension-free manner. This method~          combines the advantages of a secure repair achieved by the open method with the minimal~          invasiveness of the laparoscopic method. The investigators hypothesized that the~          lateral umbilicus ligament covering the internal hernia opening region after the~          laparoscopic purse-string knot would result in lower recurrence and the same operation~          relative complication.~   "
128029|NCT01380054|"~     The investigators aim to :~        -  describe and analyse psychological characteristics, cognitive factors and~          representations in patients with Pulmonary Hypertension, a rare disease.~        -  assess the psychological characteristics impact on quality of life, check the~          association between disease and QoL evolution, and the variability of QoL parameters~          over severity class changes and follow-up~   "
128030|NCT01380041|"~     Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain~     MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New~     therapies are also expected to improve MS care. Cytokine arrays provide measure of many~     different inflammation-related molecules that could help understanding the disease.~     Moreover, individual prognosis could be linked with the level of such molecules in the CSF~     of MS patients. The investigators will analyze the cytokine profile of MS and control~     patients CSF to determine a specific profile of MS and look for prognosis implication in a~     cohort of patients with clinically isolated syndromes (first manifesatation of MS).~   "
128031|NCT01380028|"~     The chronic subdural hematoma is a common disease in the population over 60 years. For~     example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A~     chronic subdural hematoma is an accumulation of blood in the intracranial space between~     brain membrane (dura mater) and the brain. The origin of blood in this area follows a minor~     brain injury, which causes the rupture of small vessels in the area. During its evolution,~     the volume of the hematoma increases. After a few weeks, the amount of fluid build-up can~     compress the brain. That's when clinical symptoms occur: persistent headaches, neurological~     deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired~     intellectual function, or hallucinations, etc.). The compression of the brain may cause~     impairment of consciousness resulting in more severe cases coma and death. At this stage, a~     neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over~     six months after neurosurgery). That is why in France, about 20% of medical teams administer~     a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now,~     the potential benefit of this treatment has not yet been confirmed by a clinical study. So~     the purpose of this research.~   "
128032|NCT01380015|"~     The purpose of this study is to investigate the benefits of daily consumption of a high~     rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain,~     physical function and disease activity in osteoarthritis of the knee.~      The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in~     mitigating the symptoms of osteoarthritis of the knee through its actions in reducing~     cartilage degradation, oxidative stress and inflammation.~   "
128033|NCT01380002|"~     -  Liver/renal transplantations are now tending to be the most important treatment for~          terminal liver and renal disease. Although transplantation can prevent recipients from~          suffering with critical and fatal symptoms, patients may experience the complication~          from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs~          in daily life, and so as their spouses. The purpose of this study is to explore the~          home-care needs among the post liver or renal transplant recipients and their spouses,~          and identify the significant factors for care needs.~        -  A cross-sectional correlated design will be used and patients will be recruited by~          purposive sampling from an organ transplant outpatient department at a medical center~          in northern Taiwan. A set of structured questionnaires will be used to collect data.~        -  The result of this study will be helpful for clinical nurses to understand liver or~          renal recipients' physical and mental distress, also identify the potential risk of~          home-care needs and the degree of satisfaction as well.~   "
128034|NCT01379989|"~     The objective of this multicentric, randomised, Phase III study is to demonstrate~     superiority, in terms of prolonged survival, of trabectedin and Pegylated Liposomal~     Doxorubicin (PLD) versus carboplatin and PLD.~      Patients will be randomised to:~      Arm A: PLD 30 mg/m2 and carboplatin AUC 5 Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2~     Patients'/subjects' characteristics: patients over 18 years of age with advanced,~     progressive ovarian cancer 6-12 months after completion of first line treatment with~     platinum-based chemotherapy.~   "
128035|NCT01379976|"~     Study objectives Primary: To compare toxicity free survival of patients treated with ALC~     (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with~     placebo plus cisplatin-containing chemotherapy.~      Secondary: To compare progression free survival, overall survival, the compliance to~     treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology~     Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of~     patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for~     Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as~     burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment~     arms. Study design Multicentre, randomised, double-blind, placebo-controlled, phase III,~     superiority study in patients with advanced or metastatic NSCLC (non small cell lung~     cancer).~      Patients to be screened for study inclusion are those for which the decision to start a~     cisplatin-containing treatment has been already taken in the context of the clinical~     practice. The type of cisplatin-based treatment is not fixed, but each single investigator~     is free to choose for each single patient among those already approved for first line~     treatment of advanced or metastatic NSCLC.~      Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive~     ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal,~     disease progression, unacceptable toxicity or death. The study will be conducted in Italy in~     approximately 20 investigational centers in order to recruit 650-675 subjects over a~     30-month period.~      Both efficacy and safety data will be collected. Follow-up will be according to the clinical~     practice. Data capture will continue, for each patient, until death or study closure.~   "
128036|NCT01379963|"~     This retrospective observational study will evaluate the hemoglobin levels in patients with~     renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin~     beta).~   "
128037|NCT01379950|"~     There is a growing body of evidence to suggest that the resolution of an inflammatory~     reaction is an active process. This process requiring signals that turn off early~     inflammatory stages, as neutrophil infiltration and promote resolution phase, as clearance~     of apoptotic cells. In this array,the relationship between neutrophils, monocytes, and~     macrophages is crucial for the concert process.~      Macrophages possess a plasticity of phenotype that explains their protective as well as~     potentially detrimental role in chronic inflammation and tissue injury. Such heterogeneity~     arises as macrophages differentiate from monocytes and are exposed to specific tissue- and~     hematopoietic cell-derived stimuli. It is important to be able to identify the different~     types of macrophages in this setting. Today's literature can distinguish between 3 main~     phenotypic groups of macrophages. The classically activated M1 macrophages, the~     alternatively activated-M2 macrophages and the resolution phase - rMs macrophages. The~     third phenotypic macrophage might play a crucial rule in the resolution phase, and is called~     the resolving macrophage.~      All of those pro-resolving lipid mediators promote the return to tissue homeostasis .~      The investigators hypothesis is that in periodontal patients the inflammatory process~     continues because the process does not reach the resolution phase, and in that milieu, the~     macrophage might be a key component.~      Within the overall concept of periodontal disease as a model for an inflammatory disease~     with an stoppable inflammatory reaction, the primary aim of the study is to check the~     macrophage characteristics in periodontal patients and to compare it to healthy people.~   "
128038|NCT01379937|"~     The purpose of this study is to assess the safety and immunogenicity of a prime-boost~     schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.~   "
128039|NCT01379924|"~     1. Specific Aims~        1. To evaluate the effects of life skills/parenting groups that are embedded within a~          comprehensive multidisciplinary clinic for adolescent parents (the Young Parents~          Program), using a randomized control design. Specifically, the effect of group~          participation on the following adolescent parent outcomes will be investigated:~             -  Parenting attitudes and skills including empathy, non-violent discipline, role~               appropriateness and developmentally appropriate expectations.~             -  Skills of daily living, social relationships, and work/study at follow-up, as~               measured by the Ansell-Casey Life Skills Assessment Scale.~             -  Depression and perceived social support using the CESD-C and Duke Social Support~               scale.~             -  Repeat pregnancy rates at 12 and 24 months after first delivery.~        2. To evaluate the overall Young Parents Program service delivery as required by the~          Office of Adolescent Pregnancy Programs (project funder) using a cross cutting~          evaluation of health services utilization, social needs and work/educational outcomes.~   "
128040|NCT01379911|"~     Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming~     food. Being able to effectively measure satiety is an important concept that has~     implications in the treatment and prevention of overweight and obesity. Increasing post-meal~     satiety is recognized a useful strategy for weight management. Recently, the category of~     foods marketed as having satiating effects has seen significant growth and this trend is~     expected to continue. The purpose of this project is to develop and validate methods for~     assessing the degree of satiety induced by foods and natural health products using~     commercially available food products.~      This trial will examine the effects of a commercially available yogurt (containing added~     protein and fibre) on self-reported satiety and hunger, as well as food intake in both~     controlled and uncontrolled settings.~   "
128041|NCT01379898|"~     -  Rationale: The optimal preoperative medical management for patients with a~          pheochromocytoma is currently unknown. In particular, there is no agreement with~          respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor~          antagonist to be administered before surgical resection of a pheochromocytoma. We~          hypothesized that the competitive alfa1-antagonist doxazosin is superior to the~          non-competitive alfa1- and alfa2-antagonist phenoxybenzamine.~        -  Objective: comparing effects of preoperative treatment with either phenoxybenzamine or~          doxazosin on intraoperative hemodynamic control in patients undergoing surgical~          resection of a pheochromocytoma.~        -  Study design: Randomised controlled open-label trial.~        -  Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign~          pheochromocytoma.~        -  Intervention: Patients are randomised to receive oral treatment with either~          phenoxybenzamine or doxazosin preoperatively.~        -  Main study parameters/endpoints: The main study parameter is defined as the frequency~          of intraoperative blood pressure episodes outside the predefined target range after~          pretreatment with either phenoxybenzamine or doxazosin.~      In this multicenter trial, we compare the effects of two commonly used drugs in patients~     being medically prepared for resection of a benign pheochromocytoma. Participants are not~     subjected to an experimental treatment of any kind, as we merely aim to describe in detail~     the perioperative course in general and, in particular, the intraoperative hemodynamic~     control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A~     routine diagnostic work-up for pheochromocytoma will be performed in all participants. One~     extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and~     participants need to record their symptoms in a diary. In addition, patients who are~     pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with~     an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least~     2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment~     with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by~     the nursing staff. The final site visit is planned at 30 days after surgery, in line with~     current practice.~   "
128053|NCT01379716|"~     Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are~     damaged following an outbreak of shingles.~      The purpose of this study is to identify and study abnormalities in the nerves and cells in~     the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be~     responsible for causing nerve pain. This data will be compared to the tissue of healthy~     volunteers. Our goal is that this information will lead to the development of better~     treatment options for people with painful nerve conditions.~   "
128042|NCT01379885|"~     The purpose of this study is to compare the effectiveness of a more feasible method for~     reducing the pain and distress of childhood immunization with the standard method in use at~     the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental~     involvement on the parent and child satisfaction with the immunization experience.~      Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there~     will be no statistically significant group differences between PPT and ST with respect to:~        1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary~          outcome);~        2. Parent report of child pain using the FPS-R;~        3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and~          Consolability (FLACC) scale14;~        4. Parent and child satisfaction with pain management during immunization measured by a~          5-point Likert type scales;~        5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes~          after completion of the last injection.~   "
128043|NCT01379872|"~     The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of~     Health and Ageing to undertake a project to assess new Radiation Oncology Technology and~     Treatments. This project is being undertaken in response to a recognised need for the~     Medicare Benefits Schedule to support appropriate new radiation oncology technologies and~     treatments as they become available, to ensure optimal patient care.~      The first phase of the project required TROG to develop a Generic Research Framework (the~     Framework) capable of collecting and generating information to substantiate the safety,~     clinical efficacy and cost effectiveness of new technologies and treatments.~      The second (and current) phase of the project requires that the Framework be piloted to~     assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation~     Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific~     regions:~      A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk~     Prostate Cancer (IGRT)~      The aims of the site specific components of the ANROTAT protocol are as follows:~      Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer~     (PP).~      Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC.~      Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC.~      Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical~     efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate~     risk prostate cancer.~   "
128044|NCT01379846|"~     The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when~     administered to healthy Japanese infants as multiple subcutaneous doses.~   "
128045|NCT01379833|"~     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic~     progressive or relapsing neuropathy believed to be secondary to an autoimmune response~     against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased~     corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in~     the affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our~     hypothesis is that people with CIDP have decreased corneal sensation compared to those~     without. We plan to perform a prospective study measuring corneal sensation in patients~     (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients~     with CIDP compared to controls and (2) the magnitude of the difference. If a difference is~     detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and~     patients may help prevent blinding complications.~   "
128046|NCT01379820|"~     Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of~     pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the~     pressure in the airway is variable, the investigators evaluate a closed system with a~     intubated baby with a orotracheal system but with a elastic reservoir , the reservoir~     distend and the pressure in the airway is constant ,with this system the investigators~     protect the lungs for damage . The investigators want compare the use of nasal CPAP,~     mechanical ventilation and orotracheal CPAP with a compensation bag (gregory system) in~     newborns with respiratory failure .~   "
128047|NCT01379807|"~     The clinical hypothesis of this study is that the addition of Panitumumab to the first line~     treatment combination of docetaxel plus cisplatin will provide benefit to patients with~     advanced gastric or gastroesophageal junction adenocarcinoma.~   "
128048|NCT01379781|"~     Postpartum depression (PPD) is undertreated and the consequences of this are substantial for~     women and children. Studies show that infant cry/fuss and sleep behavior are associated with~     PPD, and that parenting interventions can change infant behavior, yet these findings have~     never been applied to PPD. In this study, the investigators are teaching parenting skills to~     increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD~     to see if the investigators can prevent the onset of this disorder.~   "
128049|NCT01379768|"~     The purpose of this study was to count and analyze the white blood cells in tear samples~     collected from study participants following sleep. The results from contact lens wearers~     were compared with the results from non-contact lens wearers.~   "
128050|NCT01379755|"~     This is a comparison of the functional results and Varus-Valgus Stability in Single-radius~     versus Multi-radius Femoral Component for Total Knee Arthroplasty.~   "
128051|NCT01379742|"~     This study will investigate health related quality of life factors in patients undergoing~     low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand~     (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary,~     bowel, sexual function and bother will be measured by the EPIC questionnaire at various time~     intervals.~   "
128052|NCT01379729|"~     Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT.~     Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min~     during hyperglycemic clamp at 180 mg/dl.~      The investigators hypothesize that functional beta-cell mass will be more than 20% compared~     to healthy controls.~      Secondary outcome measurements:~      Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.~      The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against~     base-line (base-line = before first intraperitoneal transplantation):~        -  metabolic control~        -  safety parameters~        -  episodes of hypoglycemia~        -  islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and~          alloantigens using pre-transplant measurements as base-line The investigators~          hypothesize that metabolic control and prevalence of hypoglycemia, will be~          significantly improved till PT month 12.~      Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time~     of the second implant. Comparison with composition of graft, identification of~     microenvironment of host origin and correlation with functional assessment will be~     performed.~   "
128124|NCT01378507|"~     Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of~     endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The~     purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.~   "
128054|NCT01379703|"~     KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which~     lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the~     local marketing authorization with regards to dose, population and indication. No additional~     procedures (other than the standard of care) are to be applied to the patients.~      The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter~     format. The study was carried out in two (2) parts: the first part was initiated in 2004~     with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the~     lopinavir/ritonavir tablets had become available in the participating countries.~      The aim of this post-marketing observational study was to obtain further data on clinical,~     biological, and virological outcomes, compliance and tolerability of Kaletra®-containing~     regimen during routine clinical use in the participating countries.~   "
128055|NCT01379690|"~     Type 2 DM patients are at increased risk of falls as a consequence of long term~     hyperglycemic complications including retinopathy and neuropathy, and also as a result of~     hypoglycaemic therapy. Values of A1C <= 7% has been shown to increase the risk of falls in~     elderly T2DM patients .~      Increased fall risk may explain why T2DM patients are at increased risk of hip fractures ,~     despite having a higher bone mineral density as compared to non-T2DM patients. Given the~     high morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip~     fractures , all care must be given to prevent hip fractures in T2DM patients.~      There is controversial data on T2DM medications and fracture risk. Vestergaard showed that~     use of metformin and sulphonylureas decreased the risk of all fractures, while there was~     there was a similar trend with insulin.~      The present study sought to evaluate the relationship between A1c values and the risk of~     fractures in treated patients with T2DM.~   "
128056|NCT01379677|"~     The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82~     PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).~   "
128057|NCT01379664|"~     Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile~     anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble~     but more expensive anesthetic sevoflurane. Even a small reduction in the duration of~     hospitalization would easily compensate for the modest additional cost of sevoflurane. The~     investigators therefore propose to test the primary hypothesis that duration of~     hospitalization is longer with isoflurane than sevoflurane.~      The investigators will also test the secondary hypotheses that: 1) pain scores are greater~     in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid~     consumption is greater after isoflurane than sevoflurane anesthesia. All statistical~     analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.~   "
128058|NCT01379651|"~     To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in~     inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe~     IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental~     exposure to egg.~   "
128059|NCT01379638|"~     The purpose of this study is to determine whether the patients cardiac output measured~     before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs~     than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.~   "
128060|NCT01379625|"~     Humans eat long-chain fat in their diet and use it for energy during exercise and during~     periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use~     dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with~     exercise or illness. They can also develop a heart that does not function properly. These~     patients are tired and expend less energy than people who do not have a long-chain fatty~     acid oxidation disorder. However, they can use a supplement oil called medium chain~     triglyceride or MCT. This study will determine if a new experimental oil called Triheptanoin~     can decrease the muscle pain and increase the heart function and the amount of energy in~     patients with long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD~   "
128061|NCT01379612|"~     The aim of this study is to recruit 50 rectal cancer patients planned to receive standard~     radiochemotherapy. A baseline ultrasonic elastography is performed prior to~     radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment.~     The objective quantitative elastography findings are compared with the TRG score.~      The purpose is to elucidate ultrasonic elastography's ability to predict treatment response~     at an early stage by comparing quantitative ultrasound parameters before, during and after~     treatment with MR scan results and histopathological Tumor Regression Grade (TRG score)~     after operation.~   "
128062|NCT01379599|"~     The goal of the proposed project is to determine the effectiveness of a brief motivational~     intervention among Emergency Department (ED) patients who use cocaine and/or heroin to~     prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by~     comparing cumulative incidence and frequency of safe sex behavior between intervention and~     standard voluntary counseling, testing and referral to substance abuse treatment (control)~     groups over a one year follow-up period.~   "
128063|NCT01379586|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053~     across ascending single and multiple doses in healthy adult male and female subjects. The~     secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053~     in healthy adult male and female subjects.~   "
128077|NCT01379118|"~     This study is to determine the relevancy of clinical scales for outcome measures as compared~     to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee~     Society Score and the WOMAC Score will be obtained from patients. Gait data will also be~     obtained from total knee replacement (TKR) patients at pre-operative and post-operative~     times. Gait data will be measured on unaffected normal controls as a second baseline.~      The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait~     dependent outcomes amd functional performance of the total knee replacement.~   "
128112|NCT01378663|"~     One of the main problems that faces children undergoing congenital cardiac surgery is~     posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled~     Analgesia) are the main means of pain management here at NCH. In this study, the~     investigators will review the difference between different PCA and NCA modalities. Also, the~     investigators aim to find out if there are differences between age groups in terms of type~     of drug used, total drug used, side effects and length of use of the PCA or NCA.~   "
128064|NCT01379573|"~     Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a~     child with a life threatening heart condition regardless of whether they have very active~     lupus, are in remission, or have only vague symptoms. This heart problem is referred to as~     congenital heart block (the most serious being third degree complete block) and represents~     damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and~     almost all children require permanent pacemakers before the age of 20. Importantly, women~     who have had one child with heart block have a ten-fold higher risk of having another child~     with the same heart condition. Unfortunately, even close monitoring by special techniques~     during pregnancy does not reverse complete heart block once it is observed. Thus, treatments~     aimed at prevention are critical. This study will evaluate for the first time whether~     hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this~     heart condition. Data from laboratory experiments suggests that this drug, which crosses the~     placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to~     the fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage~     1 and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on~     hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that~     fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur~     out of all 54 patients if Stage 2 is reached. The results of this study are expected to~     become an integral part of the counseling of women with anti-Ro/La antibodies who are~     considering pregnancy.~   "
128065|NCT01379560|"~     The purpose of this study is to determine the pharmacodynamics of ocular blood flow~     measurements with multiple drop unoprostone isopropyl administration versus placebo in~     subjects with dry age-related macular degeneration (AMD).~   "
128066|NCT01379547|"~     The trial is aimed to show that implementation of a procalcitonin-guided antibiotics~     algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior~     outcome as compared to the conventional therapy~   "
128067|NCT01379534|"~     This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study~     to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either~     FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.~   "
128068|NCT01379521|"~     This study will evaluate the role of everolimus in combination with local Transcatheter~     Arterial Chemoembolization (TACE) procedure in patients suffering from localized~     unresectable Hepatocellular Carcinoma (HCC).~   "
128069|NCT01379508|"~     The purpose of this study is to evaluate the efficacy and safety following the Roadmap~     Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg~     negative CHB patients. The data from the study should allow for the validation of the~     Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg~     negative CHB patients. As part of a post-approval commitment to the European Health~     Authorities, the data will also be used to provide an optimized clinical treatment strategy~     for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the~     data from the study will contribute to a better scientific understanding, disease management~     and treatment of HBeAg negative CHB patients.~   "
128070|NCT01379495|"~     The purpose of this study is to assess the effect of an educative program including~     telephone follow-up for burn patients regarding the impact of this intervention on the~     health status and return to work at six months after hospital discharge.~   "
128071|NCT01379482|"~     The aims of this study are to investigate whether multimodal treatment of peritoneal~     carcinomatosis from gastric cancer is feasible and to evaluate the clinical outcomes and~     clinical effectiveness of neoadjuvant systemic chemotherapy followed by cytoreductive~     surgery + hyperthermic intraperitoneal chemotherapy + early postoperative intraperitoneal~     chemotherapy, as compared to systemic chemotherapy only, in patients with peritoneal~     carcinomatosis from gastric cancer.~   "
128072|NCT01379469|"~     The primary objective is to determine if the medication Carbamazepine, can be used as a~     therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .~   "
128073|NCT01379456|"~     To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6~     months after the fracture. The investigators hypothesis is that exercises performed after~     the initial rehabilitation, which focuses on specific components of gait control will~     improve gait and increase level of activity.~   "
128074|NCT01379157|"~     Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against~     Gram-negative and Gram-positive bacteria. This agent is often used as the last line of~     therapy for highly resistant Gram negative bacilli nosocomial infections. In common with~     other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that~     correlates with the therapeutic efficacy is the time that concentrations in the tissue and~     serum are above the MIC and administration by continuous infusion is the preferred mode of~     administration to maximize this parameter.~      However, in tropical countries, the stability of carbapenem antibiotics is an important~     consideration when considering continuous infusion. Therefore, prolonged infusion may be a~     useful mode of administration to maximize bactericidal activity. This study will demonstrate~     the stability of imipenem in clinical use at room temperature in tropical countries.~   "
128075|NCT01379144|"~     The primary objective of this study was to compare the change in intraocular pressure (IOP)~     of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50~     ug/ml dose, in a dose ranging study.~   "
128076|NCT01379131|"~     Some myocardial infarctions (MI) occur as the first manifestation of atherosclerotic~     disease. Such MIs are important because of the high likelihood of missed opportunities for~     prevention. A recent analysis using CALIBER data estimated this proportion at 60%.~      Further to this research, another level of complexity can be added to improve our~     understanding of these MIs. This is the concept of a completely 'unanticipated' MI, which~     can be defined as: MI occurring as the first manifestation of atherosclerotic disease and~     without any traditional cardiovascular risk factors and without any prior chest pain. Such~     'unanticipated' MIs cannot be foreseen by the medical profession and their frequency in the~     population is unknown.~      Therefore the aim of this study is to describe the distribution of previously diagnosed~     cardiovascular disease, cardiovascular risk factors and chest pain in patients with first~     MI. This will provide an estimate of the number of 'unanticipated' MIs and of the levels of~     risk factors in unheralded, compared to heralded MI.~   "
128078|NCT01379105|"~     The objective of this experimental study was to compare the electromyographic responses of~     sedentary youth with and without the administration of static stretching and neural~     mobilization. The sample was composed of sedentary students, divided, randomly, into neural~     mobilization practitioners (NMG; n=15; age=22±3 years), static stretching practitioners~     (SSG; n=15; age=23±4 years) and a control group (CG; n=15; age: 24±4 years). For this~     evaluation, an electromyograph (EMG; a four channel system) was used to monitor electrical~     activity in the femoral bicep muscles). In neural mobilization, hip flexion was conducted~     passively with the knee extended, and 30 plantar-to-dorsal flexion oscillations were~     completed per minute. For the static stretching, hip flexion with was completed passively~     with the knee extended and held for 6 seconds. The perception of effort was evaluated using~     the Perceived Force in Flexibility Scale. The statistical significance level was p<0.05.~     Descriptive statistics such as the average, standard deviation, median, standard error and~     absolute change within groups (post-test - pretest) were calculated. The sample normality~     was evaluated using the Shapiro-Wilk test. For the response variable analysis, the paired~     Student's t-test (paired) or Wilcoxon test (nonparametric) was used for intragroup analysis.~     For the intergroup analysis, the multivariate analysis of variance (ANOVA) test was used,~     followed by the Tukey Post-Hoc test. A p<0.05 significance level was adopted for the~     statistical evaluations. Microsoft Excel and the Statistical Package for Social Science~     (SPSS) version 14.0 were used for evaluation of the results.~   "
128079|NCT01379092|"~     The objective of this study is to evaluate the image quality and operation of a~     self-contained direct digital radiography system for breast specimen imaging.~   "
128080|NCT01379079|"~     Aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD) and is~     usually taken on awakening, although evidence regarding optimal time of intake is lacking.~     Recent studies in healthy subjects with mild hypertension showed that aspirin at bedtime~     decreases blood pressure (-7/5mmHg), whereas intake of aspirin on awakening does not.~     Additionally, the investigators found that aspirin at bedtime decreases plasma renin~     activity, catecholamines and cortisol over 24hrs. Time-dependent effects of aspirin have~     never been studied in patients with CVD, who may use concomitant antihypertensive drugs.~     Moreover, platelet reactivity has a circadian rhythm, and intake of aspirin at bedtime may~     attenuate the morning peak in platelet reactivity. The investigators hypothesize that~     aspirin intake at bedtime compared with on awakening decreases both blood pressure and~     platelet reactivity over 24h.~      A randomized open-label blinded endpoint crossover trial in which 250 patients, recruited~     from primary care, will be included who use aspirin for secondary prevention of CVD and have~     a stable blood pressure of 149/94mmHg or lower. Study subjects will randomly use both~     aspirin on awakening and at bedtime during two intervention periods of three months. Blood~     pressure will be recorded for 24hrs at the end of each treatment period in the patients'~     normal daily situation. To assess effects on platelet inhibition, thromboxane-B2 levels will~     be measured in a 24h urine sample at the end of both treatment periods. The investigators~     will asses differential effects according to time of intake on gastrointestinal complaints~     and potential minor bleeding events, as well as compliance.~      The aim of this study is to evaluate the effect of aspirin taken at bedtime compared with on~     awakening on blood pressure of subjects with stable CVD. In addition, it will generate~     insights into the effect of aspirin on platelet reactivity over 24hrs, potential side~     effects and compliance.~   "
128081|NCT01379066|"~     The Pulmonary Colonization Test is a non-invasive breath test for markers of lower~     respiratory tract infection, which may predict the probability of mycobacterial organisms in~     the lower respiratory tract. It consists of:~        -  A breath collection apparatus for collection of volatile organic compounds in breath~          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample~          of room air.~        -  Analysis of the volatile organic compounds in breath and room air by short acoustic~          wave/gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of lower respiratory tract colonization and infection.~        -  Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas~          chromatography.~      This study will test the hypothesis that the investigators can identify the presence of~     mycobacteria in an individual by sampling the breath of patients with active tuberculosis~     and by sampling head space above culture media of sputum provided. This study will test~     the hypotheses:~        -  that the investigators can identify positive cultures for mycobacterium tuberculosis~          through sampling of the headspace above the cultures prior to standard laboratory~          culture identification~        -  that the investigators can identify control of tuberculosis by sampling exhaled breath~   "
128082|NCT01379053|"~     The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus,~     which may predict the probability of bacterial organisms in the anterior nares, throat and~     respiratory tract, wounds, and anus and therefore be able to replace or supplement current~     active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists~     of:~        -  A collection apparatus for collection of volatile compounds from suspected infection~          sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate~          sample of room air.~        -  Analysis of the volatile organic compounds from suspected infection sites and room air~          by short acoustic wave gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of Staphylococcus aureus infection and colonization.~      This study will test the hypothesis that we can identify the presence of MRSA by sampling~     the head space above culture media of anterior nare samples provided by patients with~     MRSA. Additionally, this study will test the hypothesis that we can identify the presence of~     MRSA by sampling air exhaled through the nostrils (nasal exhalant).~   "
128083|NCT01379040|"~     This experiment is designed to test the effectiveness of a new electronic nose device, which~     allows a non-invasive breath test for markers of lower respiratory tract infection, which~     may predict the probability of bacterial organisms in the lower respiratory tract. It~     consists of:~        -  A breath collection apparatus for collection of volatile organic compounds in breath~          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample~          of room air.~        -  Analysis of the volatile organic compounds in breath and room air by short acoustic~          wave/gas chromatography.~        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order~          to predict the probability of lower respiratory tract colonization and infection.~      This study will test the hypothesis that the investigators can identify the presence of~     Pseudomonas aeruginosa by sampling the head space above culture media of sputum provided~     by patients with cystic fibrosis. This study will test the additional hypothesis that the~     investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath~     from the patient providing the sputum.~   "
128442|NCT01374282|"~     Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a~     Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to~     request the drug for their patients from the Sponsor. A Clinical Study Report form was~     completed for each purchase of Cuprimine.~   "
128085|NCT01379014|"~     A decision aid tool (DAT) to assist mental health service users in reaching disclosure~     decisions in the context of employment was developed in a previous study (IRAS REC ref:~     07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental~     health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after~     completion. 60% of participants reported that the DAT was quick to complete, 40% that it was~     easy, 60% that it was relevant and 80% that they would definitely or probably use it in~     making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to~     determine whether a full randomised controlled trial of the DAT is justifiable and feasible,~     and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline~     predictors of disclosure; and 3) exploration of the relationship between use of the DAT and~     the rate of disclosure.~      Eighty people who are on the caseload of a vocational specialist working with people with~     mental illness will be included in this study. All participants will be receiving treatment~     from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental~     Health Team (CMHT). An equal number from each group will be allocated to receive either the~     DAT intervention or treatment as usual. Individuals from both groups will complete baseline~     assessment and 3month followup assessments. Those allocated to the intervention will also~     complete an assessment immediately following the intervention. Qualitative interviews will~     also be conducted at 3 months with a maximum of 15 people from the intervention group and 6~     people from the control group.~   "
128086|NCT01379001|"~     This research study will look at how medications affect the pattern of blood flow in the~     brain. This study will use a special type of MRI (magnetic resonance imaging) scan called~     perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will~     use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine~     (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive~     testing will also be obtained, and correlated with the blood flow patterns in the brain.~   "
128087|NCT01378988|"~     The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety~     of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through~     <24 months, administered as an intravenous loading dose followed by continuous infusion for~     a minimum of 6 hours and up to 24 hours in an intensive care setting.~   "
128088|NCT01378975|"~     This open-label, single-arm, multicenter study will evaluate the efficacy and safety in~     participants with metastatic melanoma who developed brain metastases. Participants may or~     may not have received prior systemic treatment for metastatic melanoma [except treatment~     with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein~     kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice~     daily until disease progression, unacceptable toxicity or consent withdrawal.~   "
128089|NCT01378962|"~     This single-arm, open-label study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer.~     Patients will receive daily oral doses of 150 mg Tarceva. The anticipated time on study~     treatment is 12 months.~   "
128090|NCT01378949|"~     A psoas compartment block has been used with good results for postoperative pain relief~     after total hip arthroplasty (THA). However, case reports describing serious complications~     after the use of this block, have been reported. The fascia iliaca compartment block (FICB)~     has been shown to be a reliable block for postoperative pain relief for procedures and~     injuries involving the hip. The investigators have not found any literature that has~     compared these two blocks. This study will compare the two blocks when used for~     post-operative pain relief after THA.~   "
128091|NCT01378936|"~     The purpose of this study is to evaluate whether the Impact of Crime (IOC) group~     intervention with jail inmates reduces post-release recidivism, substance abuse, and HIV~     risk behavior.~   "
128092|NCT01378923|"~     This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values~     and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized~     that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.~   "
128093|NCT01378910|"~     CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with~     suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1~     tropism in proviral DNA could be helpful to inform in which of these subjects CCR5~     antagonists could be efficacious.~   "
128094|NCT01378897|"~     The purpose of this study is to evaluate a new educational program for people who have~     recently had gastric bypass surgery. This program involves both the use of newly developed~     wireless home monitoring technology (medication box, weight scale, and pedometer) and~     telephone-based, individually tailored health counseling with a bariatric dietician.~   "
128095|NCT01378884|"~     The purpose of this study is to determine whether domperidone can be used safely and~     effectively for patient with gastroparesis.~   "
128096|NCT01378871|"~     This clinical trial will be a multicenter phase II fixed-dose trial in which a minimum of 10~     patients with immunophenotypically confirmed ATL with at least 50% of the blasts expressing~     CD25 as measured by flow cytometry at relapse, will receive Imtox-25. Patients are eligible~     for repeat courses of treatment every two weeks if they do not experience a dose limiting~     toxicity (DLT) as defined in Section 5.2 and do not have a HAMA/HARA level > 1 μg/ml. The~     treatment will be administered in the in-patient setting. If no response is observed among~     the initial 9 patients, the study would be terminated early and declared negative; if at~     least one response is observed, accrual would continue to a total of 17 evaluable patients~     (total study size=19 to account for 10% of the patients being unevaluable for any reason).~   "
128097|NCT01378858|"~     This randomized trial will evaluate whether varenicline directly observed therapy provided~     at a methadone clinic is more efficacious than self-administered varenicline for promoting~     smoking cessation and enhancing adherence.~   "
128098|NCT01378845|"~     The purpose of this study is to evaluate the prognostic influence of light rheography~     measurement at the fingertips from subjects with secundary Raynaud syndrome.~   "
128099|NCT01378832|"~     Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.~   "
128100|NCT01378819|"~     The 3-midline-ports technique is a safety approach and associates lower postoperative pain,~     when compared with the standard French technique.~   "
128101|NCT01378806|"~     Young children who are overweight or at risk for overweight are at increased risk for~     becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To~     date, there have been no interdisciplinary interventions that targeted predominantly ethnic~     minority low-income children and parents and taught them to work together to improve~     nutrition and exercise. Using a two-group, repeated measures experimental design, this~     proposed study will test a 12-week intensive intervention on nutrition, exercise and coping~     skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight~     2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors,~     weight status, and adiposity. The study will take this intervention to the community in~     which children and parents live, working with four schools in Alamance-Burlington County,~     NC, and four schools in Wilson County in the early evening. A total of 356 Black, Hispanic,~     and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be~     inducted over 3 ½ years and randomized by school to either the experimental or control~     group. Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive~     Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up).~     Data collected will include scores on the Health Promoting Lifestyle Profile II in the~     parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy~     Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise~     Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and~     4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents~     (BMI); and adiposity in the children and parents (waist circumference and triceps and~     subscapular skinfolds). Data analysis will use general linear mixed models to test the~     hypotheses. Decreasing overweight in children and parents is urgently needed, and helping~     children and parents to work together to improve their nutrition and exercise patterns by~     making small lifestyle pattern changes may decrease future health care costs and decrease~     morbidity and mortality. The knowledge to be gained from this study may provide a foundation~     for extending this intervention to other Black, Hispanic, and White children and parents in~     other communities to assist them to manage their weight.~   "
128102|NCT01378793|"~     The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure~     compared to stimulating acupressure or a standard of care on sleep and daytime functioning.~     Also, to evaluate the ability of teaching acupressure using web-based applications.~      It is believed that self-administered relaxation acupressure will result in improvements of~     sleep quality and quantity as compared to stimulating acupressure or a standard of care.~   "
128103|NCT01378780|"~     Stroke is a disease with tremendous individual, family, and societal impact. It is the~     number one cause of adult disability and third leading cause of death in the United States.~     Between now and the year 2050, the cost of stroke in the United States will exceed 2~     trillion dollars. There is a tremendous ethnic disparity with respect to stroke in the~     United States. Mexican Americans are much more likely to have a stroke compared with~     European Americans. In Mexican Americans strokes occur at younger ages, are more likely to~     recur and have the same severity as they do in European Americans. Mexican Americans are the~     overwhelming largest sub-population of Hispanic Americans, the nation's largest minority~     group. This proposal, a scientifically-based rigorous behavioral education intervention~     trial, seeks to aggressively prevent stroke, especially in Mexican Americans.~      Faith and family are strong components of Mexican American culture. This project works with~     these positive fundamental elements in order to affect stroke prevention. This project will~     take place in Nueces County, Texas. The project investigators have worked in this community~     for the past 14 years and have published extensively regarding the stroke health disparity~     in this stable, non-immigrant community of Mexican Americans and European Americans. We have~     established a strong partnership with the Catholic Diocese of Corpus Christi and assembled a~     team with tremendous experience at successful health behavior intervention research.~     Together, a proposal has been crafted that will directly speak to aggressive stroke risk~     factor reduction in Mexican Americans and European Americans in this representative United~     States community.~      The significance of such research is tremendous. As the Mexican American population grows~     and ages, the stroke impact will be felt with greater and greater intensity. Now is the time~     to develop aggressive, scientifically tested interventions to limit the burden of this~     disease on this important segment of the United States population, and to reduce the costs~     of this disease to the country as a whole, in keeping with the Government Performance and~     Results Act (GPRA) goal to identify culturally appropriate, effective stroke prevention~     programs for nationwide implementation in minority communities by FY2010.~   "
128104|NCT01378767|"~     The investigators hypothesized that individuals supplementing with krill oil capsules (two~     grams per day) would experience enhanced improvements in health-related variables during a~     21-day Daniel Fast.~   "
128105|NCT01378754|"~     Interstitial cystitis is a condition where a defect in the protective lining of the bladder~     causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One~     way to help ease the symptoms of this disease is to fill the bladder full of water every 4~     to 6 months.~      Since this is a painful procedure an anesthesiologist will give you a drug that will make~     you unconscious for the procedure. General anesthesia can be given to you through an IV tube~     that is placed in a vein in your arm. There are only a few agents that induce sedation and~     these agents have certain disadvantages such as waking up slowly, low blood pressure, and~     pain at the injection site and a prolonged time to consciousness.~      This study will be comparing doses of a new IV sedation induction agent drug to put you to~     sleep called fospropofol (Lusedra®).~   "
128106|NCT01378741|"~     The objective of this study is to reduce the incidence of postoperative delirium after~     cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce~     delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation~     protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist~     (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource~     utilization analysis will be performed to determine cost effectiveness of the new treatment~     modality.~   "
128107|NCT01378728|"~     The primary objective of this clinical study is to evaluate the use and effectiveness of our~     'handheld' fluorescence digital imaging device platform for real-time non-invasive clinical~     monitoring of chronic wounds for healing and bacterial contamination/infectious status over~     time. This will enable us to determine if the device can detect and longitudinally track~     intrinsic changes that may occur during the wound healing process including, but not limited~     to, collagen re-modeling and bacterial infection of the wound site.~   "
128108|NCT01378715|"~     The aim of this study is to determine whether a pre-treatment with high-dose statin (one day~     prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the~     occurrence of periprocedural myocardial infarction during percutaneous coronary intervention~     (PCI).~   "
128109|NCT01378702|"~     The objective of this clinical trial is to describe safety, tolerability and the course of~     parameters of the immune system during administration of different doses of two~     subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta~     tota) in healthy volunteers, compared to placebo.~   "
128110|NCT01378689|"~     This quality improvement project is aimed at improving health care by identifying low cost~     strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with~     their physicians about osteoporosis prevention and treatment (improving doctor-patient~     communication). The investigators will implement a direct to patient intervention to the~     population of interest (patients on chronic glucocorticoids) via story-telling, using an~     Internet based video. The target audience is people on chronic glucocorticoids not already~     receiving bones-specific osteoporosis medications to determine differences in~     post-intervention rates of osteoporosis care, and the rates of prescription~     anti-osteoporosis therapies.~   "
128113|NCT01378650|"~     1. Overview of tinnitus Tinnitus is a noisy sound which is perceived without any external~          sound source. According to the survey of the US, 10-20% of adult have the symptom of~          tinnitus and 3-5% of tinnitus patients have severe discomfort of daily life. Severe~          tinnitus can result in psychiatric problems such as depression and anxiety disorders.~          Enhancement of environmental sound, hearing aids, sound generators, cognitive therapy,~          transcranial magnetic therapy, and drug therapy have been tried for treatment of~          tinnitus. Nitric oxide(NO) is a well-known neurotransmitter acting as a vasodilator~          through regulation of production of cyclic guanosine monophosphate(cGMP) and can be~          found in various sites of cochlea. It is reported that cGMP enhances activity of~          protein kinase A (PKA), a mediator of platelet aggregation inhibition and~          vasodilatation and results in increase of vascular flow.~        2. Characteristics of the clinical research drug, cilostazol Cilostazol inhibits~          phosphodiesterase type 3 (PDE3) selectively and increases amount of cAMP by inhibition~          of degradation of cyclic adenosine monophosphate(cAMP). cAMP again by increasing the~          active form of PKA suppress the production of blood clots and increase blood flow by~          expanding blood vessels. Anti-platelet activity and vasodilatation effect of cilostazol~          have been used for improvement of diabetic peripheral vascular disorders and~          suppression of stroke recurrence. Previous studies reported that by increasing the~          activity of NO and PKA, the blood flow of stria vascularis and cochlear hair cells can~          be improved. These studies implies that cilostazol, which causes inhibition of PDE3 and~          increase of PKA, can have a potential effect on improvement of tinnitus by increase of~          blood flow to peripheral cochlear cells. Thus, we hypothesized that cilostazol, which~          has been widely used for enhancing peripheral blood flow, can bring improvement of~          tinnitus by causing better peripheral blood flow of cochlea.~        3. The aim of the study We planned this study to validate the assumptions of the~          background. The aim of our study is whether administration of cilostazol can improve~          tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients.~   "
128114|NCT01378637|"~     The purpose of this protocol is to determine if individuals who had a stroke more than one~     year before entering the study and whose ankles remain substantially impaired are able to~     sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy~     device (AMES).~   "
128115|NCT01378624|"~     Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune~     cells derived from bronchoalveolar lavage after segmental allergen challenge in patients~     with asthma and pilot study to assess local inflammation induced by segmental allergen~     challenge by magnetic resonance imaging.~   "
128116|NCT01378611|"~     Clinical randomized controlled observer blinded add-on design. Additionally there will be a~     non-controlled follow-up phase of the study. Children (Age 4-18 years) with intractable~     epilepsy, and not eligible for resective surgery will be treated with VNS.~      Aim of the study:~        1. To evaluate tolerability and effectiveness of VNS in children with intractable epilepsy~          and cognitive and behavioural problems in a controlled study.~        2. To evaluate the effect of VNS on the immune system which, in its turn, will lead to~          changes in the serotonin metabolic pathway~        3. To link the therapeutic effect of VNS to changes in the serotonin (5HT) metabolic~          pathway.~      In addition the investigators hope to detect some markers of immune and neurotransmitter~     function that enable us to predict 1) Neuronal cell loss in relation to cognitive decline 2)~     the response to therapeutic treatment of VNS.~      Hypothesis:~      The investigators aim to explore neuronal correlates for cognitive morbidity in children~     with intractable epilepsy and to relate this to morphologic changes, biochemical markers,~     and to epilepsy characteristics.~      Correction of the stressed pro-inflammatory status of monocytes/macrophages via an~     electrical stimulation of the vagus nerve will prevent/ameliorate seizures as well as~     behavioural mood symptoms in children with refractory epilepsy, characterized by the~     pro-inflammatory monocyte signature~   "
128117|NCT01378598|"~     Research has found that patients sometimes have trouble obtaining oral (by mouth) cancer~     medications, understanding how to take these pills, handling side effects related to these~     drugs, and remembering to take these medications. The purpose of this research study is to~     have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide~     teaching and follow-up to patients starting erlotinib (using a teaching tool) and to test~     the feasibility of providing education and follow-up. This study will also evaluate if~     increasing knowledge about erlotinib helps participants manage side effects and stay on~     their erlotinib without interruptions.~   "
128118|NCT01378585|"~     The objective of this study are:~        1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject~        2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult~          subject~   "
128119|NCT01378572|"~     With the present study the investigators intend to identify the morphologic and~     electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated~     cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of~     sudden cardiac death. Moreover, the investigators also aim to identify if there is any~     electrophysiological substrate modification at the time of the first arrhythmic event in~     these patients. To this aim, the investigators will prospectively correlate electroanatomic~     mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify~     substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who~     are therefore more likely to benefit from a defibrillator implantation. Furthermore,~     electroanatomic mapping will be repeated at the time of the first arrhythmic event and~     compared with that at baseline, in order to evaluate any electrophysiological substrate~     changes.~   "
128120|NCT01378559|"~     The purpose of this study is to assess patient satisfaction with the Titan one touch release~     penis prosthesis and to register complications with this prosthesis. This will regard the~     first prostheses inserted at Herlev Hospital/Frederikssund Hospital.~      Patient satisfaction will be assessed by mailing out the Erectile Dysfunction Inventory of~     Treatment Satisfaction (EDITS) Questionnaire and recording the patient answers. The most~     important question will be Overall how satisfied are you with penile prosthesis?.~      Complications (including infection, bleeding, and mechanical failure) will be assessed by a~     patient chart review and confirmed by a brief phone interview.~   "
128121|NCT01378546|"~     Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in~     muscle weakness and limited reflex activity. More than half of LEMS cases are associated~     with a malignancy, usually small cell lung cancer, and tend to progress more quickly than~     cases not coupled with malignant cells.~      3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating~     the weakness associated with LEMS as it increases strength and improves autonomic symptoms~     in LEMS patients. It is not currently approved by the FDA for use in the United States. The~     investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University~     MDA/ALS Research Center.~   "
128122|NCT01378533|"~     The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and~     cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy~     for triple-negative breast cancer.~      The other purpose of this trial is to observe the patient's tolerance.~   "
128125|NCT01378494|"~     Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since~     their first exposure to HIV treatment, the investigators will conduct a cross-sectional~     study with prospectively collected data to determine BMD in 200 subjects. Subjects~     identified were initially treatment naïve when entering the University of Alabama at~     Birmingham (UAB) 1917 HIV Clinic between 1999 and 2010; some have been under observation~     without being treated with ART therapy and others were newly started on ART therapy while~     under observation. For each subject, the investigators will determine associations between~     BMD and 1) cumulative viremia, 2) ART duration, and 3) ART type.~      Hypothesis 1a: BMD will be lowest in HIV+ subjects with the highest levels of cumulative~     viremia.~      Hypothesis 1b: BMD will be greatest in HIV+ persons with longest duration of ART therapy,~     after excluding those subjects treated with tenofovir.~      Hypotheses 1c: BMD will be lower in subjects treated with tenofovir vs. other ART agents,~     after controlling for duration of therapy.~      Additionally, the investigators will conduct a retrospective study in 100 patients HIV+ and~     were ART-naïve at the time of entry into the 1917 Clinic in whom the investigators will~     longitudinally evaluate the relationship between HIV viral load, inflammation, and bone~     turnover (through the measurement of HIV copy-years viremia, interleukin-6 {IL-6}, tumor~     necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}, osteocalcin, and~     urine C-telopeptide {CTX}). The investigators will compare HIV patients at a similar stage~     of their disease who remain treatment naïve (either due to concerns for compliance or~     sufficient CD4 counts without treatment) (ART-) vs. those newly started on ART (ART+).~      Hypothesis 2: Viral load, markers of inflammation, and markers of bone resorption will all~     decrease in ART+ vs. ART- persons.~   "
128126|NCT01378481|"~     This study is being done to determine if an investigational cancer treatment called~     vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in~     treating recurrent high grade gliomas. The main goal of this research study is to determine~     the highest dose of vorinostat that can be given to patients with recurrent tumors. The~     study will also determine the potential side effects and safety of these treatment~     combinations. Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC~     inhibitors help unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them~     more susceptible to the treatment with radiation.~   "
128127|NCT01378468|"~     Non-fasting triglyceride levels are thought to play a role in stroke. The investigators~     hypothesise that the results of a standardised oral triglyceride tolerance test in the~     subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of~     recurrent stroke within 12 months after the index event.~   "
128128|NCT01378455|"~     Visual perception impairment and upper limb disability will affect the handwriting~     performance. Children with cerebral palsy (CP) who have good function on upper extremity may~     associated with visual perception impairment, which will impact the handwriting performance.~     However, there were few studies to investigate the handwriting problems in children with CP~     who have good upper limb functions. To date, there are no studies to investigate the~     effectiveness of computerized handwriting training programs on handwriting performance in~     children with CP. The aims of this study were to establish the relationships of visual~     perception, visual motor integration, and motor coordination of handwriting performance in~     children with typical development (TD) in Taiwan, to establish the norms of handwriting~     performance in children with TD in Taiwan, to compare handwriting performance in children~     with CP and children with TD, to clarify the relationship of visual perception function and~     handwriting performance in children with CP, and to examine the effectiveness of interactive~     computerized handwriting training program (ICHTP) on handwriting performance in children~     with CP.~      The investigators will collect 90 children with TD and 48 children with CP in the 1st phase.~     All children will receive clinical and Chinese handwriting assessment tool (CHAT)~     assessments. The CHAT and ICHTP will be modified as Taiwan-version handwriting assessment~     tool and training programs for children in Taiwan, respectively. Clinical assessments~     include the visual perception, visual motor integration, fine motor skill, and handwriting~     performance. The CHAT assessed the handwriting legibility, accuracy, pen pressure and~     writing speed. In the 2nd phase, the investigators will collect 48 children with CP, who~     were randomly classified into ICHTP group and Traditional Handwriting Training Program~     (THTP). All children with CP will receive clinical and CHAT assessments before and after~     interventions.~      The expected results of this study are the visual perception function is related to~     handwriting performance in children with CP, and the improvements in the handwriting~     legibility, accuracy, pen pressure and writing speed of ICHTP training group are greater~     than THTP training group.~   "
128129|NCT01378442|"~     In the first year, all subjects received clinical assessments include subjective assessment,~     basic data, nutritional status and fitness assessments. Laboratory assessments include body~     composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone~     strength (by calcaneal ultrasound) and bone metabolism.~      In the 2nd year, were randomized into three groups. The high level training group (20~     children) will receive high frequency fitness training program(Frequency: three times one~     week, Duration: thirty minutes). The low level training group (20 children) will receive low~     frequency fitness training program(Frequency: two times one week, Duration: thirty~     minutes).The control group (20 children) will not receive fitness training program but~     maintain the usual life style.~      In the 3rd year, all subjects received post-training clinical assessments include subjective~     assessment, basic data, nutritional status and fitness assessments. Laboratory assessments~     include body composition, bone density(lumbar spine and femur by dual energy X-ray~     absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.~      These data provided in this study could establish the bone quality and fitness data of~     children with diplegic CP, and provide us to plan treatment strategies in the management of~     bone and fitness problems in the future.~   "
128130|NCT01378429|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety~     study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered~     once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of~     PAR.~   "
128131|NCT01378416|"~     The purpose of this study is to determine the pharmacokinetics (PK) of decitabine~     administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia~     (AML).~   "
128132|NCT01378403|"~     Schizophrenia patients in comparing to normal controls show decreased ability to identify~     objects with decreased level of fragmentation, a task that is associated with magnocellular~     pathway function.~   "
128133|NCT01378390|"~     The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem~     cells) for treatment of complex perianal fistulas in patients with Crohn's disease.~   "
128134|NCT01378377|"~     The research trial is testing the experimental drug MSC1936369B (Pimasertib) and the drug~     TORISEL, given together, in the treatment of advanced solid tumors. The primary purpose of~     the study is to determine the maximum tolerated dose and the recommended Phase II dose~     (RP2D) of the drug combination.~   "
128135|NCT01378364|"~     The aim of the study is to investigate safety, tolerability and pharmacokinetics of single~     rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to~     healthy male volunteers.~   "
128136|NCT01378351|"~     The purpose of this study is to characterize the accompanying symptoms, evaluation and~     management of patients with chronic vestibular dysfunction presenting with nausea and~     vomiting.~   "
128137|NCT01378338|"~     Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD~     in Korea-an observational study.~   "
128153|NCT01378130|"~     Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore~     further investigations are needed. During this study patients with an acute episode of~     central serous chorioretinopathy are observed with established ophthalmologic methods~     (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further~     insides in etiology, course and prognosis of this disease.~   "
128138|NCT01378325|"~     Rapid administration of crystalloid immediately after induction of spinal anesthesia~     (coload) to be more effective in terms of managing hypotension as compared to administering~     crystalloid before spinal anesthesia (preload).~      Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of~     hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of~     high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid~     coload up to two liters (administration at the time of SA). However, incidence of reactive~     hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may~     raise concern in patients in whom increase of blood pressure may be detrimental, like~     chronic hypertension and in the presence of a compromised uteroplacental blood flow. A~     recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is~     associated with more episodes of hypertension than placebo or the lower infusion rates of 25~     and 50 ug/min respectively. However, there was no reduction in the number of physician~     interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal~     systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate~     infusions may have limited application in clinical practice, and a variable rate (i.e.~     modifying the rate according to hemodynamics) has been advocated. The bolus administration~     of phenylephrine to treat hypotension is still commonly used, but requests multiple~     interventions from the anesthesiologists and is time consuming.~      Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to~     one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated~     Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will~     receive infusion of normal saline (placebo) and patients in group II variable infusion rate~     of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed~     infusion rate). The number of interventions needed to maintain maternal systolic blood~     pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and~     vomiting, and umbilical cord blood gases will be compared between the two groups.~      We will define a reliable and safe method to ensure maternal hemodynamic stability during~     spinal anesthesia for cesarean delivery with the least physician interference.~   "
128139|NCT01378312|"~     This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study~     in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of~     tuberculosis infection. The study will be conducted at one clinical research site in India.~      The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete~     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or~     booster, while not toxic, does not provide much additional protection. AERAS-402 presents~     tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus~     vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis.~     Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,~     AERAS-402 will be administered to individuals already vaccinated with BCG.~   "
128140|NCT01378299|"~     Testosterone (T) replacement prevents bone loss and relieves symptoms associated with~     androgen deficiency in male patients with hypogonadism, but at the expense of an increase in~     prostate-related adverse events and in the hematocrit values above the normal which may lead~     to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by~     its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the~     aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2~     and T. This project is designed to determine if genetic variations in the CYP19A1 gene will~     result in differences in the skeletal response and incidence of side effects from T~     treatment in patients with low T. A large number of male Veterans are on T. Results from~     this project will help identify patients who would benefit from the therapy from those at~     risk for side effects, and would definitely have an impact in the future care of these~     patients and male patients in general once genetic profiling becomes part of the standard of~     care.~   "
128141|NCT01378286|"~     Primary Objective:~      - To demonstrate the non-inferiority of corrected adequate clinical and parasitological~     response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine~      Secondary Objectives:~        -  To assess the non inferiority on the same way as the main criteria:~        -  at Day 28 before corrected cure rate~        -  at Day 14 and Day 42 before and after corrected cure rate~        -  To compare the two groups of treatment in terms of:~        -  Efficacy:~             -  Proportion of aparasitaemic patients at 24, 48 an 72 hours~             -  Proportion of afebrile patients at 24, 48 and 72 hours~             -  Percentage of gametocyte carriers during follow-up~             -  Evolution of the mean of gametocytes during the 42 days of follow-up~             -  Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28~        -  Clinical and biological tolerability:~             -  Proportion of any adverse event~             -  Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells,~               neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino~               transferase/ALT), bilirubins)~             -  ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old~               and above~   "
128142|NCT01378273|"~     Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo~     decreases neuronal programmed cell death resulting from brain injury; it has~     anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from~     injury.~      We hypothesize that neonatal Epo treatment of ELGANs will decrease the combined outcome of~     death or severe NDI from 40% to 30% (primary outcome), or the combined outcome of death plus~     moderate or severe NDI from 60% to 40% (secondary outcome) measured at 24-26 months~     corrected age.~        1. To determine whether Epo decreases the combined outcome of death or NDI at 24-26 months~          corrected age. NDI is defined as the presence of any one of the following: CP, Bayley~          Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Scale < 70~          (severe, 2 SD below mean) or 85 (moderate, 1 SD below mean). CP will be diagnosed and~          classified by standardized neurologic exam, with severity classified by Gross Motor~          Function Classification System (GMFCS).~        2. To determine whether there are risks to Epo administration in ELGANs by examining, in a~          blinded manner, Epo-related safety measures comparing infants receiving Epo with those~          given placebo.~        3. To test whether Epo treatment decreases serial measures of circulating inflammatory~          mediators, and biomarkers of brain injury.~        4. To compare brain structure (as measured by MRI) in Epo treatment and control groups at~          36 weeks PMA. MRI assessments will include documentation of intraventricular hemorrhage~          (IVH), white matter injury (WMI) and hydrocephalus (HC), volume of total and deep gray~          matter, white matter and cerebellum, brain gyrification, and tract-based spatial~          statistics (TBSS based on diffusion tensor imaging). As an exploratory aim, we will~          determine which of the above MRI measurements best predict neurodevelopment (CP,~          cognitive and motor scales) at 24-26 months corrected age.~      Anticipated outcomes: Early Epo treatment of ELGANs will decrease biochemical and MRI~     markers of brain injury, will be safe, and will confer improved neurodevelopmental outcome~     at 24-26 months corrected age compared to placebo, and will provide a much-needed therapy~     for this group of vulnerable infants.~   "
128143|NCT01378260|"~     The specific aim of this study is to prospectively compare outcomes (functional, quality of~     life, risk-adjusted clinical event) of medical management, surgical or endovascular~     (angioplasty or stent placement) interventions for the treatment of claudication caused by~     peripheral arterial disease. This study will test two major hypotheses;~      Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements~     in function, claudication symptoms, and health-related quality of life (HRQoL) than~     endovascular procedures or medical management.~      Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with~     greater improvements in function, claudication symptoms, and HRQoL than medical management.~   "
128144|NCT01378247|"~     The purpose of this study is to determine whether Family Focused Nursing are effective in~     the treatment of heart failure outpatients with respect to health-related quality of life.~   "
128145|NCT01378234|"~     The Enhanced Discharge Planning Program (EDPP) is an intervention designed to help older~     adults safely transition to the community after discharge. This is achieved through~     telephonic care coordination facilitated by social workers. EDPP social workers ensure full~     implementation of the discharge plan, assist with coordinating community resources and~     follow-up appointments, and intervene around other issues that may arise as a result of a~     complex transition.~      The EDPP intervention is currently being offered to some older adult patients discharged~     from Rush University Medical Center. Case managers refer older adult patients on selected~     units who they believe may be at risk for adverse events post-discharge. While this service~     is being provided to patients, it has not yet been formally evaluated. This randomized~     controlled trial will provide data necessary for a more rigorous evaluation of the efficacy~     of this intervention.~   "
128146|NCT01378221|"~     Advanced age is associated with an increase in postoperative morbidity and mortality in~     cardiac surgery patients. In detail, compared with younger patients those aged 75 years and~     older have significantly higher rates of in-hospital mortality, cerebrovascular events,~     pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical~     ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system.~     Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of~     vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in~     cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term~     mortality in patients with a high risk for cardiovascular disease. Mild renal impairment,~     insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly~     individuals. The present study aimed to investigate whether cardiac surgery exerts~     age-dependent effects on calciotropic hormones, components of the immune system, and~     inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels~     are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery~     results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the~     decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger~     cardiac surgery patients.~   "
128147|NCT01378208|"~     The Danish Food Administration recommends eating three main meals and three small meals a~     day in order to maintain a healthy lifestyle. However, there is little research to support~     this concept- moreover, many studies shows that fasting can have a positive impact on our~     health.~      HYPOTHESIS AND PURPOSE The investigators hypothesize, that the number of meals per day in~     order to maintain a healthy lifestyle will not differ in normal weight subjects.~      The investigators will include 1) healthy, normal weight subjects. The investigators will~     study the effects of two daily meals.~      More specifically, the investigators want to better understand how the body reacts to~     long-term, intermittent fasting (14 h /day for 4 weeks). The investigators will assess~     cognitive function, dietary intake, appetite regulation, fitness, glucose and insulin~     responses, as well as fat and muscle composition of the body before, during, and after the~     study.~      Our long-term goals are to compare the effects of intermittent fasting with acute fasting.~     All of this is in an effort to establish how our eating habits ultimately affect our health~     and to, perhaps, contribute to new recommendations for healthy eating in normal weight~     population.~      BACKGROUND Obesity and diabetes are increasing health threats facing the Western world~     today, despite abundant research efforts and campaigns to prevent such outcomes. Throughout~     the years, as the incidence of both obesity and diabetes in the general population has~     increased, so too has the typical number of daily meals. A once common three meals per day~     has now increased to six meals per day, in many instances. Recent animal research has shown~     that intermittent fasting (one or two meals per day) over a long period of time can improve~     cardiovascular health and prevent chronic diseases. Biochemically, fasting leads to an~     activation of metabolic mechanisms designed to preserve carbohydrates and increase the~     dependence on energy produced by the metabolism of fat. There is little scientific evidence~     regarding the number of meals per day that proves to be the healthiest, and those studies~     that do exist have opposing conclusions. Several theories do exist regarding the number of~     meals per day that affect us in the most favorable way, but these are just theories. Our~     study is the first to assess, in both a systematic and controlled setting, how long-term,~     intermittent fasting affects the human body.~   "
128148|NCT01378195|"~     Photozig and Stanford University are creating a program to help cope with caregiving,~     alleviate related stress, and enhance quality of life for caregivers, with funding from the~     National Institute on Aging. This home-based program includes a free DVD, printed materials,~     and resource website. In addition, after completing the program, participants will have free~     access to final online resources for 1 year. There are no face-to-face meetings, and~     participants can live anywhere in the United States.~   "
128149|NCT01378182|"~     Wilson's disease is an autosomal recessive genetically inherited disorder of copper~     metabolism, causing neurological, psychiatric and liver disease. The ATP7B gene on the 13th~     chromosome is responsible for the disease. Liver has a critical role on copper metabolism.~     It is the main site of copper accumulation and bile secretion is the only physiologic way of~     copper elimination. Due to defective production of ceruloplasmin which carries copper, wide~     amount of free copper precipitates throughout the body but particularly in the liver, eyes~     and brain. Patients are bound to lifelong chelating agents such as penicillamine, trientine~     and tetramine dihydrochloride. Unfortunately, these medications may cause severe~     side-effects such as hypersensitivity reactions, bone marrow suppression, auto-immune~     disease and sideroblastic anemia. Medical treatment of liver cirrhosis, the last stage of~     the illness that leads to morbidity and mortality in the Wilson Disease, is difficult. Liver~     transplantation is still the most effective treatment for the patients with liver cirrhosis~     in Wilson Disease. However, serious problems are accompanied with liver transplantation.~     Lack of liver donors, complications during and after the surgery, graft rejection and high~     costs are the main problems.~      There are cells in the human body that are capable to renew themselves and differentiate to~     a diverse range of specialized cell types. These are called stem cells. Stem cells can be~     differentiated to specialized cells in appropriate medias in the laboratory. Recently, the~     differentiation potential of mesenchymal stem cells into hepatocytes is proved by~     demonstrating hepatocytes containing Y chromosome in the female who has had bone marrow~     transplantation from male donors. In many laboratory studies, it is observed that human bone~     marrow derived mesenchymal stem cells, transplanted to animals with induced liver damage,~     differentiate into the albumin producing hepatocytes without fusion. By these studies, it is~     understood that mesenchymal stem cells are more potent than other bone marrow elements in~     context of differentiation to hepatocytes. Even though the number of studies on human for~     the same purpose is few, findings are supporting those of animal experiments. Mesenchymal~     stem cells are non-immunogenic. Safety and feasibility of allogeneic transplantations~     between individuals without need of immunosuppressive drug regimen are proven. Proofs of~     correcting metabolic defects by this way are also presented in some publications. For the~     reasons mentioned above, allogeneic mesenchymal stem cell transplantation is a promising~     treatment modality especially for the hereditary metabolic diseases. By this way,~     non-immunogeneic mesenchymal stem cells which have healthy genetic structure, can~     manufacture the required enzyme, will be repopulated in the damaged tissue and contribute to~     the clinical improvement.~      In this study, mesenchymal stem cells will be derived from healthy volunteer donor's bone~     marrow and be expanded in-vitro, and then 1 million cells per kg will be infused to patients~     with liver cirrhosis related to Wilson disease, 50 million cells via hepatic artery and the~     remaining cells via peripheral vein. It is aimed to enable liver regeneration, decrease~     fibrosis rate, improve patient's health conditions, increase ceruloplasmin synthesis,~     ameliorate disorder of copper metabolism, decrease the need for chelating agents, increase~     living standards of patients, and prolong waiting time for liver transplantation. Finally it~     is aimed to establish a new and regenerative treatment protocol alternative to liver~     transplantation. For observation of clinical and laboratory improvement, patients are~     planned to be monitored by histopathologic examination of liver biopsies before and at 6th~     month after the treatment, monthly biochemical and hematologic blood tests and periodic~     radiologic examinations. This is a hopeful, avant garde and sophisticated study which may~     constitute new horizons in context of cellular therapies.~   "
128150|NCT01378169|"~     Aim of the study : The primary aim of the investigators study is to highlight the presence~     of biomarkers (biological indicators of the presence of inflammation or infection) of~     infectious processes during the systemic inflammatory response (SIRS) allowing, first to~     discriminate non-infectious inflammation from infectious processes and secondary to~     determine the microbial pathogen responsive of the infection. For this purpose the~     investigators will conduct a combinatorial approach of several blood markers including usual~     markers of inflammation and other blood and cells markers. Expression of small pieces of RNA~     (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a~     specific group of white blood cells involved in the fist line of defences against microbes.~      Study design : For this purpose the investigators will include 300 patients admitted to the~     intensive care unit with suspicion of infection. Serial blood sample will be take for~     biological parameters analysis. Efficiency of each single parameters and of different~     combinations of different markers to determine the presence or absence of infection~     responsive of clinical inflammation will be studied.~   "
128151|NCT01378156|"~     GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia~     who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test.~     This study has 3 phases. The first phase is the vaccination phase, where patients are~     vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second~     phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12~     week period approximately 8 weeks following the last vaccination. The third phase occurs~     after the 12 week treatment interruption phase and is called the treatment reinstitution~     phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The~     primary objective is to evaluate the safety of the vaccines during the three phases of the~     study. A secondary objective is to evaluate the immunogenicity of the vaccines during the~     vaccination phase of the study.~   "
128152|NCT01378143|"~     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS~     in combination with standard of care as a second line treatment in subjects with~     unresectable and locally recurrent or metastatic colorectal cancer.~   "
128488|NCT01373658|"~     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and~     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel~     from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd)~     may prevent these complications.~   "
128154|NCT01378117|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the~     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been~     tested in the hospital. It is not known if sitagliptin is as effective in controlling blood~     sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine)~     injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar~     in hospitalized patients with diabetes.~      In this pilot study, patients with known history of diabetes treated with diet and/or OAD or~     with low total daily dose insulin therapy (<0.4 unit/kg/day) will be randomized to receive~     sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily~     (group 2), or basal bolus regimen with glargine once daily and lispro insulin before meals~     (group 3). If needed, patients in the 3 treatment groups will receive correction doses of~     rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per~     sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or~     in combination with basal insulin in patients with type 2 diabetes will result in a similar~     improvement in glycemic control and in a lower frequency of hypoglycemic events than~     treatment with basal bolus insulin regimen with glargine once daily and lispro insulin~     before meals.~      A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will~     be recruited at Grady Memorial Hospital and Emory University Hospital.~   "
128155|NCT01378104|"~     1. Randomized controlled multicenter study~        2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic~          hepatitis C genotype 1~        3. IL28B polymorphism in Koreans with CHC~   "
128156|NCT01378091|"~     Primary objectives:~      To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given~     every three weeks and prednisone, as combination therapy to subjects with androgen~     independent prostate cancer~      To evaluate the safety profile of the combination of daily lenalidomide and every three week~     docetaxel and prednisone when given to subjects with androgen independent prostate cancer~      Secondary objective:~      To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week~     docetaxel and prednisone when given to subjects with androgen independent prostate cancer.~   "
128157|NCT01378078|"~     Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in~     healthy subjects and depressed patients. In this study, patients with treatment resistant~     negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI~     measures will be performed.~   "
128158|NCT01378065|"~     This is a prospective, multi-center study designed to assess the palpability of the~     Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.~   "
128159|NCT01378052|"~     Many studies previously showed the significant association between urinary arsenic profiles~     and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower~     plasma folate and higher homocysteine than those with higher plasma folate and lower~     homocysteine. The investigators would expect to explore the interactions among global DNA~     methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.~   "
128160|NCT01378039|"~     Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to~     even increase in many countries. Both from a clinical and a pathophysiological point of~     view, this is an important issue. However, an understanding of the relationship between the~     complex array of cells and mediators involved in asthma and COPD is not yet fully dissected~     which makes difficult to find a specific and sensitive panel of biomarkers that can reflect~     intensity of these pathological processes and can help to predict the individual outcome.~   "
128161|NCT01378026|"~     G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and~     it encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72~     and D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of~     schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and~     R38H DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our~     preliminary data showed that the level of G72 autoantibody decreases in patients with ALS~     compared with normal control. Thus, we want to find out whether G72 plays a role in ALS and~     neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we~     detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using~     ELISA and Western blotting, and the data are compared with normal control. We hypothesize~     the levels of G72 protein and its autoantibody in neurodegenerative diseases are less than~     those in normal control. Then, we extract genomic DNA of neurodegenerative diseases~     patients, and use polymerase chain reaction(PCR) to detect single nucleotide polymorphism~     (SNP) of G72. We aim to detect G72 missense SNP variants presented in ALS, AD and PD.~   "
128162|NCT01378013|"~     This work will use a new approach to measure how surgery effects human biochemistry and~     metabolism. It will create a metabolic signature or 'phenotype' for surgical injury that~     will help clinicians choose the right surgical treatments for an individual. This is because~     metabolism is based on an individual's genes, disease burden and environmental influences~     such as gut microbiota. This study will use a scientific method based on computational~     analysis of spectra taken from techniques known as Mass Spectrometry (MS) and Nuclear~     Magnetic Resonance (NMR) spectroscopy. This science is called 'metabonomics' and it has many~     advantages. Firstly, it provides a measure of thousands of metabolites at a single moment in~     time that are unique to the individual and it therefore gives a 'systems' overview of a~     persons metabolism. Secondly it is able to process many hundreds of samples quickly. The~     investigators are aiming to integrate the investigators metabolic data with genetic~     information about patients or bacteria wherever possible. This will be the first time that a~     'systems biology' approach has been used in surgery, with potentially significant gains to~     me made in pre operative risk stratification and optimisation. By performing this analysis~     at all stages of the surgical journey (preoperatively, during the operation and after the~     surgery) it will ensure the right treatments are given to the right patient at the right~     time. By creating longitudinal models of the biochemical responses to surgery, predict at a~     much earlier stage those patients at risk of developing complications. This will improve~     outcome after surgery. This work will use a metabonomic approach to create new tools for~     surgeons to use during operations based on tissue biology. For example the investigators~     will be able to measure the metabolic content of tumours in real time by measuring the~     biological content of diathermy smoke. This has the potential to change intra-operative~     decision making and further improve outcome.~   "
128241|NCT01376947|"~     In this study the investigators compare the difficulty at insertion of IUD between~     nulliparous and parous women. The investigators compare the pain reported by the patient to~     the difficulty reported by the professional that performed the insertion.~      The investigators hypothesis is that there is no difference between nulliparous and~     multiparous patients.~   "
128163|NCT01378000|"~     A clinical trial to study the effects of dosage, infusion methods and complications of~     unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted.~     In this study, we observed the effects of four UFH treatments on 480 acute progressive~     cerebral infraction patients during from the 6th and the 72nd hour after the attack. It was~     concluded that the ultra-slow continuous intravenous infusion of UFH can significantly~     reduce the neurological deficit score of patients with progressive cerebral infarction,~     increase the cure rate, decrease the recurrence rate, and improve long-term quality of daily~     life. It is more effective than the treatment of intravenous infusion of low- molecular-~     weight UFH at once a day, and the risk of bleeding may not necessarily be increased.~   "
128164|NCT01377987|"~     The ultimate goal is to improve our understanding of the pathophysiology and resistance to~     effective treatment of sleep disordered breathing in patients with heart failure, with a~     focus on selecting patients that will benefit specifically from acetazolamide treatment.~      The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the~     apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients~     with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with~     the most severe ventilatory control instability (strongest chemoreflex response to carbon~     dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory~     control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary~     congestion, and cardiac function.~   "
128165|NCT01377974|"~     The purpose of this study is to determine whether miltefosine is effective in the treatment~     of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.~   "
128166|NCT01377961|"~     Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular~     with respect to its contribution to cardiovascular disease. The progressive increase in~     prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and~     mortality in all populations around the world. Conventional stepwise treatment of DM2~     generally focuses on controlling blood glucose concentration. However, the risk for~     side-effects associated with the use of pharmacological intervention often delays initiation~     of therapy, with the potential implication on worsening morbidity and mortality from~     complications. On the other hand, non-pharmacological intervention in the form of dietary~     restrictions, exercise and weight loss, is safe but often difficult to accomplish. The~     availability of nutrients that affect glucose and lipid metabolism would provide an~     important practical tool to establish early intervention in newly diagnosed DM2 and perhaps~     even in patients who are only at risk for DM2. The investigators have recently obtained~     preliminary data on beneficial effects of combined supplementation of lycopene and~     isoflavones on glucose metabolism of normoglycemic volunteers with insulin resistance. This~     clinical trial will explore the role of isoflavones and lycopene dietary supplementation in~     the improvement of glucose metabolism of patients at increased risk or with established but~     mild DM2. The overall hypothesis is that supplementation of laflavon, provided as a new~     formulation that increases bioavailability of the individual components (Laflavon CamMedica~     contains 7 mg of Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose~     tolerance and insulin resistance of patients with the metabolic syndrome and also reduces~     HbA1c in patients with mild DM2.~   "
128167|NCT01377948|"~     The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate~     and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a~     pediatric inpatient psychiatric unit.~   "
128168|NCT01377935|"~     The purpose of this study is to compare the incidence of hospitalization for acute kidney~     injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those~     who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl~     peptidase IV (DPP4) inhibitors.~   "
128169|NCT01377922|"~     A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients~     with Lambert-Eaton Myasthenic Syndrome (LEMS).~   "
128170|NCT01377909|"~     Objective: The goal is to improve peginterferon sensitivity in previous poor responders.~     Sensitivity here means the host's ability to kill more HCV.~      Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin~     monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.~   "
128171|NCT01377896|"~     'Real life' retrospective patient cases (10) to provide an objective and robust analytical~     report of patient management and prescriptions behaviours for Schizophrenia, Bipolar~     disorders and Major depressive disorders.~   "
128172|NCT01377883|"~     Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum~     toxin (BTX) injections that are administered several times a year. While clown care reduces~     preoperative anxiety, its effect on painful procedures has not been assessed. We~     hypothesized that medical clowning reduces pain and anxiety during BTX injections.~   "
128173|NCT01377870|"~     Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which~     affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter~     problems. The disease is caused by an autoimmune mechanism, ie the immune system produces~     antibodies and cells which attack the self myelin antigens, causing therefore demyelination.~     The disease is clinically evident with relapses of neurological disability due to the~     dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.~     Disability can accumulate with time and the disease enters a progressive phase due to damage~     of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist~     which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of~     MS (like Copaxone and interferons), there is no effective means today to stop the~     progression of disability and induce rebuilding of the destroyed myelin.Adult bone marrow~     derived stromal cells (MSC) were shown to induce similar (to the neuronal stem cells)~     immunomodulatory and neuroregenerative effects and were shown in our laboratory to induce~     neuroprotection in the animal model of chronic experimental autoimmune encephalomyelitis~     (EAE). These bone marrow derived MSCs offer practical advantages for clinical therapeutic~     applications, since they can be obtained from the adult bone marrow and therefore the~     patient can be the donor for himself, without any danger for rejection of the cells. In~     addition, MSCs carry a safer profile and are less prone to malignant transformation.~      Our center will perform a clinical trial with intra venous transplantation of bone marrow~     derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell~     transplantation after 1year following up.~   "
128174|NCT01377857|"~     Over twenty percent of HIV-positive persons in the United States are unaware of their~     infection, leading the Institute of Medicine to recently urge further work to compare the~     effectiveness of HIV screening strategies. This study will use a randomized trial to compare~     several variants of emergency-room-based HIV-testing policies in order to determine how HIV~     test acceptance rates can be increased. The testing policies will be designed using~     principles from behavioral economics, varying the choice architecture and offering small~     monetary incentives. This will be the first study to measure differences in take-up rates~     across a variety of promising but largely untested approaches within a unified randomized~     trial. Three defaults will be tested: traditional opt-in (test only those patients who~     request testing), opt-out (routinely testing unless patients decline), and active-choice~     testing (patients are required to state whether they want to be tested). The study will also~     be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up.~     An additional novel study contribution will be to test the hypothesis that compliance with~     large requests (accept an HIV test) increases after making a small request or pre-commitment~     - this foot in the door technique has not been previously studied in this setting. The~     factorial design will permit a direct comparison of all interventions, as well as~     interactions. The study will contribute a nuanced empirical understanding of how testing~     protocols from behavioral economics theory affect the effectiveness and efficiency of~     screening programs in an actual scaled- up setting (San Francisco General Hospital). This~     will assist in implementing and assessing recent CDC guidelines on HIV screening, while also~     more generally advancing scientific knowledge related to applying behavioral economics in~     comparative effectiveness research.~   "
128175|NCT01377844|"~     The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated~     Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels~     at 24th week from baseline, when compared to placebo group(no diabetic medication given).~     The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting~     blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study~     assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American~     Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with~     placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures,~     body weight and compare with the respective placebo groups.This study also assess the change~     from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of~     EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).~   "
128176|NCT01377831|"~     To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer~   "
128177|NCT01377818|"~     Objective: To analyze the additional benefits of exercise training application by the~     non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic~     respiratory failure. SUBJECT: moderate-severe COPD (FEV1 <60%) in chronic respiratory~     failure (hypoxemia and hypercapnia PaCO2> 45mmHg). GROUPS: 45 patients included~     prospectively and randomly into 3 groups of 15: a) training + NIPPV group, b) Group~     training, c) Group NIPPV. Hypothesis: A training program to the effort associated with~     treatment with NIPPV significantly increase the effects compared with each treatment. MAIN~     OBJETIVE: Effects on exercise capacity as measured by the test of endurance cycling and test~     6-minute walk (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as~     measured by questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α),~     changes in peripheral muscle strength (1RM test, isometric) and effects score BODE index.~   "
128178|NCT01377805|"~     Multiple sclerosis patients commonly develop generalized ventricular dilation with or~     without cerebral atrophy over time. Case studies in the literature have noted some multiple~     sclerosis patients develop the typical normal pressure hydrocephalus triad of dementia,~     gait disturbance and incontinence which were responsive to shunts.~      Many patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple~     Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over~     10% more Ehlers-Danlos patients than in the normal population.~      Because studies are indicating a form of external communicating hydrocephalus in the~     Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur~     in the Multiple Sclerosis population.~      To evaluate this hypothesis, investigators will retroactively evaluate the head~     circumference of Multiple Sclerosis patients between birth and 15 months (before the skull~     sutures have closed).~   "
128179|NCT01377792|"~     A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective,~     open and randomized of long-term treatment with hypertonic saline in cystic fibrosis~     patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of~     major volume (10 ml) increases the free time without pulmonary exacerbation, and if this~     increase is superior to the obtained with the inhalation of the standard volume (5 ml) that~     has been advocated.~   "
128180|NCT01377779|"~     This is a prospective single blind randomized controlled pilot study was designed to~     investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of~     intrauterine adhesions following hysteroscopic treatment for retained products of~     conception.~   "
128181|NCT01377766|"~     The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine~     whether psychological factors are the potential risk factors for the occurrence of BP.~   "
128182|NCT01377753|"~     Background:~      - One way to treat prostate cancer is to use a laser to direct extreme heat to a small area~     of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors~     want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI~     will be used to help locate tumor cells and guide the laser during surgery. However,~     MRI-guided laser therapy has not been used to treat many people with prostate cancer. More~     studies are needed to see whether it can destroy tumor cells permanently.~      Objectives:~      - To test the safety and effectiveness of treating prostate tumors with laser therapy guided~     by magnetic resonance imaging.~      Eligibility:~      - Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has~     not spread to other parts of the body.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and imaging studies, and will complete questionnaires about their~          health.~        -  Participants will have the MRI-guided laser treatment in the hospital. The doctor will~          use the MRI to control how much energy is delivered by the laser and how much tissue is~          destroyed. The entire procedure usually takes from 1.5 to 3 hours.~        -  After the treatment, participants will have a catheter put in to keep the bladder~          emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and~          bladder spasms will be given. Participants will leave the hospital once they are well~          enough to go home.~        -  Participants will have followup visits 3, 6, 9, 12, 18, 24, and 36 months after the~          therapy. They will have physical exams, and blood and urine tests. They will also~          answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after~          the therapy. They will have a prostate biopsy to see if there is any tumor every 12~          months for the first 2 years. Another biopsy may be done in the third year.~   "
128183|NCT01377740|"~     This study is being performed to reduce unwanted abdominal fat using two different~     applicators for the Zeltiq System.~   "
128184|NCT01377701|"~     Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to~     damage of vision. This study aims to evaluate the predictive factors for recovery of vision~     in patients with pituitary adenomas following trans-sphenoidal surgery.~   "
128185|NCT01377688|"~     We propose to pilot a telehealth approach to evaluate components of risk communication by:~        1. Providing personalized tailored patient feedback to help initiate and maintain specific~          diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight,~          exercise, diet, smoking cessation) to reduce their risks.~        2. Evaluating how this feedback can be incorporated into clinical care by examining 6~          month patient outcomes.~      Specific Aims are:~        1. To evaluate the feasibility and acceptability of providing both patients and their~          provider feedback on individuals' DKD risk via the telehealth intervention and~          incorporating it into regular clinical practice.~        2. If improvements in outcomes are found, to estimate the cost of the program in terms of~          the patient, provider, and overall costs of implementing the program.~   "
128186|NCT01377675|"~     This study involves the development and evaluation of a web-based, interactive education~     program on chronic obstructive pulmonary disease (COPD) for primary care clinicians.~      The research questions that this proposal addresses include:~        1. Can an interactive, web-based COPD course be developed to disseminate evidence-based,~          best practice recommendations to primary care clinicians?~        2. Can assessment tools be developed to evaluate the impact of the program on clinician~          behavior in clinical practice and on patient care?~   "
128187|NCT01377662|"~     The main purpose of this study is to determine the outcome of a drug combination treatment~     on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users.~     The combination regimen consists of oral administration of a generic immediate-release~     methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release~     formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment~     tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment~     outcome. In addition to the treatment outcome measures, we will determine whether the~     14-day, once-a-day treatment leads to significant changes in the~     pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or~     Ond-PR002 formulations and drug-drug interactions between the two drugs.~   "
128188|NCT01377649|"~     Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body~     by ultrasound detection of microbubble contrast agents that behave in the circulation~     similar to red blood cells. In this study, the investigators hypothesize that contrast~     ultrasound of blood flow in the leg (thigh and calf) at rest and during stress produced by~     medications that mimic exercise (vasodilator stress) can provide information on the location~     and severity of peripheral vascular disease (blockages of the blood vessels in the leg). The~     investigators will also determine whether symptom improvement after revascularization~     (procedures to open up or bypass the blockages) is directly related to the improvement in~     blood flow.~   "
128189|NCT01377636|"~     Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary~     data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS~     is used to monitor neuronal signals under anesthesia. The BIS level is suggested to~     correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS~     values because it increases the patient's level of consciousness through its central nervous~     system (CNS) stimulatory effects. In this study, we will administer increasing doses of~     isoproterenol to EPS patients. We will measure the BIS levels continuously before and after~     isoproterenol administration. In addition, we will test the level of awareness of patients~     by their response to a modified isolated forearm technique.~   "
128190|NCT01377623|"~     The aim of the proposed study is to examine the effect of DEX on the inflammatory response~     in major surgery. More importantly, the investigators will correlate changes in the~     concentration of inflammatory mediators with meaningful clinical outcomes.~   "
128191|NCT01377610|"~     The investigators will randomize 210 opioid-dependent participants to one of two outpatient~     detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper~     from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single~     administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day~     15 for the buprenorphine group. The naltrexone arm is a modification of our current~     inpatient naltrexone induction procedure, consisting of a single day of buprenorphine~     followed by a washout day and 4 days of ascending oral naltrexone doses, prior to~     administering a dose of injectable naltrexone on Day 8. All participants will receive an~     intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks~     to assess the longer-term outcome of the initial treatment. The primary outcome will be~     percentage of patients in each group successfully inducted onto Vivitrol. Key secondary~     outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol~     injection), rates of completion of the 8-day detoxification, and percentage of patients in~     each group who return for additional Vivitrol injections in post-study follow-up. The main~     goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification~     strategy, with particular relevance to newly diagnosed heroin addicts and prescription~     opioid abusers not seeking long-term agonist maintenance.~      Specific Aim #1: To develop procedures for outpatient opioid detoxification which include~     naltrexone to facilitate detoxification.~      Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and~     buprenorphine groups following short-term outpatient opioid detoxification approach for~     initiating treatment for opioid dependence.~   "
128192|NCT01377597|"~     The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly~     intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment~     due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the~     applicability of the phase III study results of BRAVO and CRUISE in this indication, in the~     Japanese ethnic patients.~   "
128193|NCT01377584|"~     The purpose of this research study is to examine the effect of a couple-oriented education~     and support intervention on patient- and partner -reported outcomes (positive airway~     pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).~   "
128194|NCT01377571|"~     The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1~     produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in~     infants in Vietnam. In addition, we evaluate different dosages and schedules to determine~     the best regimen to test in a clinical trial.~   "
128195|NCT01377558|"~     The purposes of the study are~        -  to determine which kind of supervised exercise intervention (aerobic endurance training~          versus strength endurance training versus combined aerobic endurance and strength~          endurance training) is more effective in improving the metabolic parameters in typ 2~          diabetes patients~        -  to investigate what kind of intervention is more successful in reduction of concomitant~          diseases and improving quality of life~        -  to assess what kind of intervention induces highest effects in long term persistence of~          these positive changes~   "
128196|NCT01377545|"~     The investigators propose to test the hypothesis that when placing a perineural catheter for~     a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the~     insertion needle results in a faster-onset sensory block than injecting the initial bolus~     via the perineural catheter. The study results will help define the optimal local anesthetic~     bolus introduction technique—needle versus catheter—for peripheral nerve blocks when placing~     a perineural catheter.~   "
128197|NCT01377532|"~     This is a compassionate use protocol to allow palliative therapy for patients with malignant~     pheochromocytoma and paragangliomas.~   "
128198|NCT01377519|"~     This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved~     treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis~     is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a~     sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with~     symptomatic uterine fibroids to participate in the trial. Participants will be randomly~     assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS~     treatment. Participants will remain blinded to their group assignment for 3 months. After 3~     months, participants will be told their treatment group and those assigned to the sham group~     will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are~     inappropriate candidates for a 3 month delay in fibroid treatment, such as those with~     significant anemia. The investigators will assess the change from baseline to 1 and 3 months~     after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and~     hematocrit.~   "
128199|NCT01377506|"~     Obesity is a major public health problem among older adults, with 31% of~     non-institutionalized older persons (60 years+) in the US obese and projections indicating~     that this will rise to 40% by 2010. A second public health challenge on the horizon for the~     aging US population is the increasing number of individuals experiencing cognitive decline,~     dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in~     reducing risks associated with both of these significant and increasingly pervasive health~     problems, which are more common among rural, low income and ethnic minority populations. The~     Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in~     a large, diverse population of high-risk individuals and dramatically reduced rates of type~     2 diabetes onset, particularly among older adults. SeniorWISE produced improvements in~     memory in community dwelling older persons. Transferring these exciting technologies to~     community settings where they can benefit older adults is a pressing public health need.~     Therefore, the current project seeks to transfer these two evidence-based interventions to~     older adults in a rural state using senior centers as the venue for dissemination and lay~     health educators to deliver the interventions. Senior centers are a particularly attractive~     context for translation of evidence-based health promotion technologies in predominantly~     rural states like Arkansas because they have a well-established infrastructure in~     communities and share a common goal of promoting healthy aging and reducing health care~     costs. The 3-year randomized, controlled trial will evaluate translation of the~     interventions by randomizing senior centers (N=16) across Arkansas to implement either (1)~     the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program.~     Older (age > 60) adults (N=288) nested within senior centers will receive the programs~     delivered in a group format by a trained lay health educator. Primary outcomes are changes~     in body weight and cognitive functioning at 12 months. The multi-level evaluation plan will~     characterize reach, effectiveness, adoption, implementation and maintenance of the~     interventions, with a cost effectiveness component.~   "
128200|NCT01377493|"~     There were no differences in the degree of enamel remineralization of subsurface lesions~     among the chewing gums containing or not containing POs-Ca and fluoride.~   "
128201|NCT01377480|"~     This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of~     asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg~     twice daily improves therapeutic response compared to placebo in participants with a~     diagnosis of asymptomatic chronic Chagas disease.~   "
128202|NCT01377467|"~     The primary objective of the study is to examine the effect of denosumab on lumbar spine~     bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft~     recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck,~     changes in body height, changes in bone mineral metabolism parameters, incidence of~     fractures, and allograft function at one year. Safety measurements include the occurrence of~     rejection episodes, infectious complications, graft loss and mortality.~        -  Trial with medicinal product~   "
128203|NCT01377454|"~     The purpose of this pilot project is to determine whether using one inertial sensor on the~     waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)),~     will be a more immediate, objective, reliable and sensitive way to measure and quantify~     balance deficits in individuals with mild Traumatic Brain Injury (mTBI).~   "
128204|NCT01377441|"~     The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has~     not been studied extensively. Subjects are being asked to participate in this study because~     they are scheduled for surgery and because the investigators want to study ways to improve~     recovery from surgery. Ibuprofen will be given several times before and after surgery. The~     investigators will ask questions to determine recovery and the investigators will draw blood~     to determine inflammatory response.~   "
128205|NCT01377428|"~     The study will be a 12 week treatment (84 days), parallel group, randomized, double blind,~     double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol~     (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).~      Patients will be enrolled after giving informed consent and then begin a screening/run-in~     period for 14 days. Patients will be randomized to one of two treatment groups using an~     allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to~     formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period~     of 12 weeks.~   "
128206|NCT01377415|"~     The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion~     after shoulder arthroscopy with standard surgical techniques, including rotator cuff~     operations. The investigators hypothesized that patients having 5.0 mg/ml bupivacaine~     infusion at a rate of 2 ml/h subacromially would need less opioids than patients receiving a~     placebo infusion.~   "
129146|NCT01365104|"~     The purpose of this study is determine if the iron chelator, desferrioxamine can increase~     blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there~     is a corresponding increase in blood flow to the brain.~   "
128207|NCT01377402|"~     The first aim of this trial is to assess the long-term prognostic value of Omega-3 index,~     which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to~     other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter~     observational study of 982 chest pain patients admitted to the emergency unit, employing~     blood samples collected at admission.~      The second purpose of this study is to evaluate the prognostic utility of vitamin D in the~     same population.~      The third purpose of this study is to assess the incremental prognostic value of B-type~     natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).~   "
128208|NCT01377389|"~     The goal of this clinical research study is to learn if ipilimumab in combination with~     either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect~     prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also~     want to learn if these drug combinations affect the body's immune system. The safety of~     these drug combinations will also be studied.~   "
128209|NCT01377376|"~     The primary objective of this study is to determine if the combination regimen of ARQ 197~     with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in~     subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have~     received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT)~     population.~   "
128210|NCT01377363|"~     This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the~     metastasis of patients with primary breast cancer HER2. 236 patients have been recruited and~     32 Sites have been taking part in this Clinical Trial.~      Primary Objective:~        -  To determine prospectively the probability of stage HER2 conversion between the~          different subtypes of primary breast cancer (luminal, triple negative and HER2) and~          their metastasis.~      Secondary Objective:~      - To determine the probability of changes in ER and PR between different subtypes of primary~     breast cancer and their metastasis.~        -  Analyze the variability in the measurement of HER2, ER and PR between local~          laboratories and central laboratory.~        -  Evaluate HER2 conversion rate compared to previously received treatment.~        -  Evaluate whether the location of metastasis biopsied relates to the probability of~          conversion of HER2.~        -  Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients~          with or without conversion of HER2 and ER/PR.~        -  Compare the response rate (RR) and time to progression (TTP) for subsequent anti-tumor~          treatment of patients with or without conversion of HER2.~        -  Analyze the extent to which discrepancies in the HER2 receptor status, ER and PR~          between the primary tumor and metastasis alter the clinical management of patients.~        -  Analyze the feasibility of performing biopsies.~        -  Evaluate whether the HER2 status conversion really is associated with activation of~          intracellular markers of the HER2 signaling pathway: pMAPK, PERK, pAKT, PTEN, PIGF-1R~          in paired samples (primary tumor and their metastasis).~        -  Check if there is any change in the molecular subtypes (luminal, triple negative, HER2)~          between primary tumors and metastases in patients with HER2 conversion.~   "
128211|NCT01377350|"~     The purpose of this study is to explore the feasibility of monitoring hemodynamic changes,~     which result from heart failure exacerbations, by recording the respiratory effort, chest~     wall dynamics and quantifying the development of dyspnea by using miniature mechanical~     sensors that are attaches to the chest.~   "
128212|NCT01377337|"~     Out-of-hospital cardiac arrests (OHCA) account for over 60% of deaths from coronary artery~     disease. The annual incidence of OHCA treated by Emergency Medical Systems (EMS) is 41-89~     per 100,000 population. Outcome of OHCA and cardiopulmonary resuscitation (CPR) is very~     poor: Less than 1/3 of the victims regain spontaneous circulation (ROSC), 40-60% of those~     achieving ROSC suffer significant neurological disability due to brain hypoxia and only~     1.7-6.4% are discharged from the hospital. In order to minimize hypoxia time, the primary~     goal of CPR is to achieve return of spontaneous circulation (ROSC) as fast as possible.~     Metabolic (lactic) acidosis develops rapidly during CA and is considered detrimental to CPR~     outcome. Sodium bicarbonate (SB), a generic, commonly used acid buffer, was subjected only~     to a single, small, prospective controlled trial that found a trend towards improved outcome~     in prolonged OHCA and CPR. Another study indicated that EMS's that used SB early and often~     during CPR had significantly higher ROSC rates and better long-term outcome compared with~     EMS's that used SB more seldom and administered it late in the course of CPR.~      Aim of the Study:~      To determine whether early administration of SB during OHCA and CPR improves short-term CPR~     outcome.~   "
128213|NCT01377324|"~     The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently~     subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging~     using positron emission tomography with the ER-specific FES tracer. In this pilot study we~     will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of~     ER binding sites in 15 metastatic breast cancer patients.~   "
128214|NCT01377311|"~     Name of the project：The application of cornea stem cells cultured on amniotic membrane in~     patients suffering from corneal stem cell insufficiency~      Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell~     cultured on amniotic membrane for treatment of patients suffering from limbal stem cell~     insufficiency~   "
128215|NCT01377298|"~     Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity~     profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in~     cisplatin-refractory recurrent or metastatic HNSCC.~   "
128216|NCT01377285|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to~     investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin~     receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with~     Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will~     also be observed. The observation period will be 3 years. The primary endpoints consists of~     doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The~     secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary~     levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein),~     TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen~     III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum~     fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure,~     nonfatal myocardial infarction, and stroke or transient ischemic attack.~   "
128217|NCT01377272|"~     Data will be extracted from the National Taiwan University Hospital (NTUH) medical records~     database, geocoded according to the street address so that the case number, incidence, etc~     could be mapped. The spatial data would be used to detect the aggregation of HIV cases,~     existence of hot spots and then determine if they may merit further investigation or may~     have occurred by chance. The results from these GIS-based analyses would address local~     variations in HIV prevalence and transmission.~   "
128354|NCT01375465|"~     The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary~     intervention (PCI) to assess the clinical success, efficacy and safety of the~     Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial~     bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat~     the stenotic site branch.~   "
128218|NCT01377259|"~     Neuraxial anesthesia affords a less interventional way to desensitization of the lower body~     for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body~     part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent~     is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and~     the response of volume redistribution. It is believed that vasodilatation leads to better~     regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser~     doppler flowmetry and thermography showed their effectiveness on monitoring blocked level~     but they were not easily available in the operation room. Recently Near-infrared~     spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied~     generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the~     tissue oxygenation change over the upper and lower limbs during the induction of neuraxial~     anesthesia.~   "
128219|NCT01377246|"~     The general aim of the trial is to assess the efficacy of one year treatment with~     long-acting somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney~     and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency and to~     assess whether and to which extent this translates into slower renal function decline over~     3-year follow-up.~   "
128220|NCT01377233|"~     The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics~     of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.~   "
128221|NCT01377220|"~     Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.~      Recently, several research studies reported that 11C-choline PET has shown a high detection~     rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of~     this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to~     detect HCC in cirrhotic or non cirrhotic patients.~   "
128222|NCT01377207|"~     Recent studies suggest important gender differences in the pathophysiology and prognosis of~     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled~     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus~     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related~     mechanisms of plaque rupture or erosion will be investigated using a combination of~     Quantitative Coronary Angiography, high resolution Optical Coherence Tomography of the~     culprit vessel and histopathologic analyses of thrombus aspirates of the infarct related~     lesion, performed by independent core laboratories, blinded to group (male or female) and~     clinical variables.~   "
128223|NCT01377194|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).~   "
128224|NCT01377181|"~     The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic~     hernia repair is especially advantageous for bilateral diseases and minimally invasive~     technique in children because it avoids vas injury. However, the problem of recurrent rate~     has not been resolved. The aim of this study was to refine the current criteria used the~     lateral umbilicus ligament covering the internal hernia opening region, and eliminated~     recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators~     hypothesized that the lateral umbilicus ligament covering the internal hernia opening region~     after the laparoscopic purse-string knot would result in lower recurrence and the same~     operation relative complication~   "
128225|NCT01377168|"~     This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be~     randomized to receive either oral naltrexone for the treatment of alcohol use disorder or~     placebo. Men with acute, recent or established HIV infection will receive antiretroviral~     treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study~     is to see whether use of oral naltrexone improves medication compliance, and therefore HIV~     viral load suppression, among men with alcohol use disorder. The study will also assess the~     impact of oral naltrexone on alcohol use behaviors in this population.~   "
128226|NCT01377155|"~     This study will evaluate two methods of starting basal insulin to see which method may~     achieve a faster-to-goal titration.~   "
128227|NCT01377142|"~     The purpose of this study is to evaluate surgical success or failure one year after surgery~     for pelvic organ prolapse.~   "
128228|NCT01377129|"~     The main objective of this study is to compare, using MRI measures with a specialized~     splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using~     single bundle and double bundle surgical techniques, between the seventh and eighth months~     after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).~   "
128229|NCT01377103|"~     The purpose of this study is to evaluate whether benefits of topical testosterone on~     symptoms and function of male HF patients, and its effects on rehospitalization rates and~     quality of life.~   "
128230|NCT01377090|"~     The CAP study is a multicenter, observational, clinical study in patients with systemic~     sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and~     patient-specific disease-related factors in predicting the occurrence of digital ulcers~     within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis~     (limited or diffuse), with or without history of digital ulceration are eligible. The study~     will enroll 500 patients at 70 centers.~   "
128242|NCT01376934|"~     Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine~     cavity and investigate of abnormal uterine bleeding . The success of the procedure is based~     on the distension of the cavity . It can cause pain and discomfort and sometimes the~     procedure fails. . There are two techniques to make the procedure , one with gas and the~     other with saline solution. Objective: to compare two techniques concerning pain , procedure~     duration and image quality~   "
128243|NCT01376921|"~     This is a Spanish, Multicentre, Observational Study to study adherence and long term~     outcomes of therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
128244|NCT01376908|"~     This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate~     efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in~     less than 4 year-old infants and children with phenylketonuria (PKU).~   "
128355|NCT01375452|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fasting conditions.~   "
128231|NCT01377077|"~     Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo.~     However, no reliable data are available on the effect of punch depth and punch size.~      Objectives: Primary: to compare the efficacy and safety of different punchdepths and~     punchsizes in punch grafting in patients with segmental and non-segmental vitiligo.~     Secondary: to assess the practical aspects and patients preference of different punch~     grafting techniques.~      Study design: Prospective observer blinded randomised controlled study. Study population: 35~     patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular~     treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the~     Academic Medical Centre University of Amsterdam.~      Methods: Four depigmented regions on the trunk or upper extremities will be randomly~     allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal~     1,5 mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will~     receive UV-therapy twice a week for 3 months. Three and six months after grafting, the~     repigmentation of the lesions will be assessed by measuring the outgrowth.~      Main study parameter/endpoint: Outgrowth of pigment after six months.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The study involves 16 additional punch grafts but no additional visits to our~     institute. Patients will not miss any regular treatment. The extra time due to participation~     in the study will be about 40 minutes. No increase of the risk of side effects is expected~     by placing 16 additional punch grafts. 1.~   "
128232|NCT01377064|"~     Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living~     longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise~     and increased physical activity can reduce the risk factors for these diseases in PLWHA, but~     no studies have tested an at-home exercise program that would benefit low income people and~     others who do not have access to exercise facilities. This study will test the feasibility~     of an at-home exercise program for PLWHA and prepare for a full-scale intervention study,~     which may lead to a reduction in CVD risk among PLWHA.~   "
128233|NCT01377051|"~     The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg)~     is effective in the acute treatment of COPD and in particular on reducing lung~     hyperinflation and dynamic volumes.~   "
128234|NCT01377038|"~     The primary objective of this study is to evaluate the relative efficacy of a~     centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical~     diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary~     objectives include the determination of which self-report and experimental pain measures~     best differentiate those who respond better to duloxetine than diclofenac.~   "
128235|NCT01377025|"~     Uveal melanoma is the most common primary intra-ocular malignancy in adults with an~     incidence of 0.6 - 0.7 per 100,000 per year.~      Prognosis of metastatic uveal melanoma is poor. In retrospective analyses a median survival~     time after detection of metastases of 5 months (Flaherty et al, 1998) and 7 months (Kath et~     al, 1993) was reported. For patients receiving no treatment reported median survival was 2.0~     months compared with 5.2 months for those receiving treatment for metastases (Gragoudas et~     al, 1991).~      Up to now there is no established treatment of metastatic uveal melanoma. Some therapeutic~     approaches with locoregional treatment or systemic chemotherapy have been undertaken:~      In case of metastatic disease which is confined to the liver in about 85% of patients with~     uveal melanoma surgical resection led to a median survival of 14 months (Mariani et al,~     2009) or 19 months and a 5-year survival rate of 22% in a selected patient population (Adam~     et al, 2006).~      As locoregional treatment option treatment with fotemustine via direct intra-arterial~     hepatic infusion was investigated and led to a median survival of 15 months (Peters et al,~     2006). This was not a randomized trial, but a report on 101 consecutive treated patients.~     Additional debulking surgery was performed whenever feasible.~      A randomized phase III trial comparing intra-arterial hepatic fotemustine administration~     with intravenous systemic fotemustine and overall survival as primary endpoint is still~     ongoing (EORTC 18021).~      Thus, no systemic chemotherapy is approved for metastatic uveal melanoma. Although no~     specific genes have been linked to the pathogenesis of uveal melanoma, preclinical studies~     suggest potential benefit of inhibitors of Bcl-2, ubiquitin-proteasome, histone deactylase,~     mitogen-activated protein kinase and phosphatidylinositol-3-kinase-AKT pathways, and~     receptor tyrosine kinases.~      Thus, sorafenib as inhibitor of b-Raf and Raf-1 (c-Raf or c-Raf-1), pro-angiogenic vascular~     endothelial growth factor receptor (VEGFR), and platelet-derived growth factor receptor~     (PDGFR) may potentially lead to a benefit for patients with metastatic uveal melanoma in~     terms of disease control and prolongation of survival.~   "
128236|NCT01377012|"~     This study will assess the safety and efficacy of secukinumab when added to a background~     therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had~     an inadequate response to anti-tumor necrosis factor (TNF)-α agents.~   "
128237|NCT01376999|"~     The aim of the study is to evaluate if the Step up protocol is equal or superior regarding~     efficacy and security than the step down protocol. In couple submitted two intrauterine~     insemination.~   "
128238|NCT01376986|"~     The aim of the study is to investigate different novel IC technologies for promoting~     physical activity and health and preventing obesity in young men. The purpose is to provide~     new evidence-based knowledge on the effectiveness of an ICT-based physical activation and to~     identify factors predicting a positive response.~      Specific objectives~        -  to identify the factors associated with physical activity and physical activity~          relationship in young men~        -  to develop an interactive method, based on peer networks, aimed at activating young men~          with use of their own skills, participation and modern ICT~        -  to assess the effectiveness of the chosen activation on the physical activity, weight,~          fitness, health, and relationship towards physical activity among young men~      The study population consists of all conscription aged men in the Oulu area in 2011-2013~     (n=4000). Conscription-aged men provide a large, population based representative sample of~     young men. In Finland military service is mandatory and annually all 18-year old men are~     called for military service. In the call-ups fitness for service is determined based on~     medical examination.~      All those who are determined fit for service or who are granted postponement due to obesity~     will be invited for the activation intervention study. Those with severe obesity are~     exempted from service, but will also participate in the trial. After the call-up, the men~     will be randomised to an intervention group and a control group. The primary outcome~     variable is change in physical activity.~      The study will be conducted during 2011-2015. The study includes technology development (ICT~     platform), collection of cross-sectional data at the call-ups, and a 6-month physical~     activity intervention (a randomized controlled trial) implemented between the call-up and~     start of military service. Game mechanics are integrated into the ICT platform to increase~     user engagement and participation.~      Physical activity, fitness (aerobic and muscular), body composition,lifestyle and~     psychological and physical health will be followed. In addition, the subjects' entry into~     military service and its course will be followed.~   "
128239|NCT01376973|"~     Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers~     are exposed to stress. Aim of the study was to evaluate clinical and electromyographically~     the effect of two different occlusal splints on police officers with TMD~   "
128240|NCT01376960|"~     The purpose of this study is to compare, for the first time ever, single shot popliteal~     fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot~     procedures. The primary outcome variable for this study is the percentage of patients that~     convert to general anesthesia following either a single shot popliteal fossa block or ankle~     block.~      H0: There is no difference in the percentage of patients that convert to general anesthesia~     between single shot popliteal fossa blocks and ankle blocks.~      HA: There will be a lower percentage of patients receiving a single shot popliteal fossa~     block that convert to general anesthesia compared to patients receiving an ankle block.~   "
128245|NCT01376895|"~     The goal of this study is to develop and test a program to help Black men who have sex with~     men and women reduce their chances of getting or giving HIV infection to their sex partners.~     The program is designed to be delivered via the internet so that it would be available to~     more men. Men who agree to participate in the study will be assigned by chance to receive~     the POWER intervention or a similar program that is focused on general health called~     POWER-HEALTH. They will also complete a computer administered interview when they first~     enroll in the study, 2 weeks following the last session of the program and 3 months after~     that. Participants will receive a small compensation for their time and effort.~   "
128246|NCT01376882|"~     The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as~     compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral~     blood flow effects will also be assessed in a subset of participants. The role of caffeine~     abstinence/maintenance in the acute effects of caffeine will also be explored.~   "
128247|NCT01376869|"~     Hops have been used for many years for their supposed sedative and anxiety reducing~     properties and can be found in many natural remedies for stress, anxiety and sleeping that~     are already available to buy.~      However, human trials investigating the effects of hops have so far been limited to the~     effects of the combination of hops and valerian in relation to sleep. Such studies have~     identified that a valerian-hops mixture can result in improved sleep but Valerian alone has~     no effect.~      The current study aims to investigate the effect of hops alone in healthy human participants~     aged 18-35 years.~   "
128248|NCT01376856|"~     The purpose of this study is to analyze pathologic and radiologic characteristics of~     mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and~     assess relationship between false positive mediastinal lymph node and TB/latent TB.~   "
128249|NCT01376843|"~     The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and~     Quantiferon-TB Gold In tube assay in health care workers.~   "
128250|NCT01376830|"~     Respiratory virus infections are a common cause of COPD exacerbations and antiviral~     therapies have potential as treatments for exacerbations. However it is likely that treating~     patients when they present with an exacerbation with antiviral drugs will be too late to be~     effective and earlier treatment at the time of the initial upper respiratory tract infection~     (URTI) will be required. The incidence of exacerbations following URTIs in COPD patients,~     and whether there are host factors and biomarkers that can identify the risk of this, is~     unknown. The aims of this study are to establish the proportion of viral URTIs that progress~     to an acute exacerbation in COPD patients and identify clinical, viral and biological~     markers that predict risk of an exacerbation following an URTI. In addition we will~     determine the frequency of, and risk factors for, bacterial infection following viral URTIs~     in COPD patients. This data will permit development of a model combining baseline patient~     characteristics, clinical measurements and biomarkers to predict exacerbation risk following~     viral URTI in COPD patients. The results will open the way for trials of antiviral therapy~     in COPD exacerbations and targeting of treatment to high risk patients.~   "
128251|NCT01376817|"~     The purpose of this study is to comparatively assess the potential antiinflammatory effects~     of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil~     versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of~     patients with severe acute pancreatitis during the period in needing artificial nutrition~     support with total parenteral nutrition so unique.~   "
128252|NCT01376804|"~     This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte~     (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant~     recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte~     orally daily for up to 200 days post-transplant and will be followed for 52 weeks~     post-transplantation.~   "
128253|NCT01376791|"~     We propose to examine a population of Native Americans who have had little or no dental~     care, and to determine if periodontal disease is associated with early signs of vascular~     dysfunction or systemic inflammation. We then propose to treat the periodontitis and~     re-evaluate vascular function. We will determine if gingivitis or mild/moderate~     periodontitis is associated with detectable vascular dysfunction. Microbial metagenomics~     will be correlated with vascular function.~   "
128254|NCT01376778|"~     Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects.~     When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue,~     weakness, fever, swollen glands). Most people in the United States are infected during~     childhood or as adults if they work around children. Pregnant women, who have not been~     infected with CMV in the past and become infected during pregnancy (i.e. a primary~     infection), may cause their babies to get infected with CMV. Babies that are infected may~     develop permanent disabilities including hearing loss and a small portion will die from the~     infection.~      Currently it is not routine practice to screen pregnant women for CMV infection.~     Additionally, there is no agreement about how to evaluate and manage pregnant women infected~     with CMV for the first time. There is also no evidence that treatment is beneficial for the~     baby.~      The purpose of this research study is to determine whether treating pregnant women who have~     a primary CMV infection with CMV antibodies will reduce the number of babies infected with~     CMV.~   "
128255|NCT01376765|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study.~     Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and~     Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by~     Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein~     Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg~     per 0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml~     dose. PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower~     phosphate concentration). Approximately 84 healthy male and nonpregnant female subjects 18~     to 40 years of age will be enrolled.~   "
128256|NCT01376752|"~     CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial~     ovarian cancer is able to improve the median OS by 12 months. In that hypothesis, with alpha~     risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years~     follow-up, the number of patients to include is 404. Taking into account a 10% failure, an~     overall number of 444 patients is required.~   "
128257|NCT01376739|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Magnevist at a dose of~     more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging~     from the abdomen to the lower extremities. The objective of this study is to assess safety,~     especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical~     practice. A total 2,000 patients will be recruited.~   "
128258|NCT01376726|"~     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in~     healthy, HIV-uninfected adults who have participated in a previous HIV vaccine clinical~     trial and in healthy, HIV-uninfected adults who have not participated in a previous HIV~     vaccine clinical trial.~   "
128259|NCT01376713|"~     The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w~     Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable~     stage III or stage IV melanoma.~   "
128260|NCT01376700|"~     The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg~     ADVATE started at or before 1 year of age and before the onset of a severe bleeding~     phenotype (ie, joint bleeding), together with the minimization of immunological danger~     signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and~     moderately severe hemophilia A.~   "
128261|NCT01376687|"~     Back pain affects the majority of the population at some time. Currently there are no~     published and scientifically accepted objective measures to support manual medicine~     diagnostic and treatment techniques for back pain. The purpose of this project is to collect~     and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.~   "
128262|NCT01376674|"~     Immunological effects of radiotherapy have been described before, but not evaluated in a~     time-dependant manner.~      In order to identify a possible time frame for combination therapies, white blood cells are~     isolated of samples taken at different time points before during and after standard~     radiotherapy in patients with localised prostate cancer. The overall activity of the~     T-cell-system as well as tumor-specific T-cell-response are evaluated.~   "
128263|NCT01376661|"~     The purpose of this research study is to monitor the feasibility and outcome of the Active~     Surveillance Program for men with low risk prostate cancer.~   "
128264|NCT01376648|"~     Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although~     the regulatory factors are not well known in humans. There is evidence suggesting that the~     thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid~     hormones on BAT activity in humans are still unclear. The objective of this study was to~     investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in~     humans.~   "
128265|NCT01376635|"~     Background/Aims: To evaluate the sympathovagal balance in patients with chronic kidney~     disease (CKD) on conservative treatment. Methods: In a cross-sectional study, patients with~     CKD stages 3, 4 and 5 not yet on dialysis (CKD group) and age-matched healthy subjects (CON~     group) underwent continuous heart rate recording during two twenty-minute periods in the~     supine position (pre-inclined), followed by passive postural inclination at 70° (inclined~     period). Power spectral analysis of the heart rate variability was used to assess the~     normalized low frequency (LFnu), indicative of sympathetic activity, and the normalized high~     frequency (HFnu), indicative of parasympathetic activity. The LFnu/HFnu ratio represented~     sympathovagal balance.~   "
128266|NCT01376622|"~     Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands,~     particularly the pituitary gland, remains common in patients with transfusion dependent~     anemias. We would like to establish accurate population norms of pituitary R2 and volume and~     understand the progression of pituitary iron in transfused patients on Deferasirox.~   "
128267|NCT01376609|"~     Previous research has shown there wasn't inevitable relationship between mismatch area and~     infarct growth according to Volumetric-subtraction mismatch volume.The recently published on~     Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace~     ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch.~     But the correlation between the mismatch, calculated by Coregistration mismatch method,and~     the clinical outcome of the patients with acute ischemic stroke is still unknown. so the~     investigators plan to conduct a prospective observational cohort study.~   "
128268|NCT01376596|"~     This study will explore the helpfulness of a short psychological group treatment called~     cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and~     it aims to improve difficulties that are related to behaviors and emotions by first working~     on identifying and changing negative inaccurate thoughts. The main goal of this intervention~     is to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia~     so that they can improve their social functioning and help their psychotic symptoms. The~     study compares the usefulness of adding CBT to standard services.~   "
128269|NCT01376583|"~     The study investigates the explanation for the positive relation found between exercise and~     breastcancer.~   "
128270|NCT01376570|"~     This study will test whether contingency management (monetary vouchers contingent on~     abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads~     to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a~     randomized controlled trial, the investigators propose to test whether an~     abstinence-reinforcing contingency management intervention improves viral load suppression~     in HIV-infected drug users.~   "
128271|NCT01376557|"~     This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in~     combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate~     glycemic control on metformin monotherapy.~   "
128272|NCT01376544|"~     During assist control ventilation and pressure support ventilation (PSV), the start of~     ventilator inflation is determined by the start of the infant's inspiratory effort. During~     PSV, termination of inflation is determined by the level of the infant's inspiratory flow.~     In a randomized trial, no significant differences were found between assist control and~     pressure support ventilation with regard to the duration of weaning, time to successful~     extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.~   "
128273|NCT01376531|"~     The aim of the study is to characterize the influence of continuous veno-venous hemodialysis~     on the cerebrovascular autoregulation.~   "
128276|NCT01376492|"~     The purpose of this study is to establish the relationship between performance of patients~     with schizophrenia and relationship with perceived quality of sleep. The secondary~     objectives are: to establish the prevalence of schizophrenic patients reporting sleep~     disturbances; to assess the potential epidemiological risk factors associated with the~     perceived impairment of quality of sleep; to establish the relationship between the clinical~     condition and the quality of sleep perceived; to assess the performance level of patients.~   "
128277|NCT01376479|"~     The purpose of this study is to evaluate the safety and immune response of an inactivated~     vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).~   "
128278|NCT01376466|"~     The purpose of this study is to determine whether computed tomography is reliable~     investigation in the diagnosis of acute appendicitis.~   "
128279|NCT01376453|"~     The main purpose of this study is to find the maximum tolerable dose of sorafenib when~     administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about~     whether these drugs, along with radiation, can help people with rectal cancer when given~     before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration~     (FDA) for use in people with rectal cancer.~      The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of~     the study, the investigators will attempt dose escalation of sorafenib in combination with~     standard infusional 5-FU and external beam at standard doses. Clinical staging should be~     done by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T~     and N stage; chest and abdomen computed tomography (CT) for staging of metastatic disease;~     undergo sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken~     for diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of~     sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile~     and efficacy.~   "
128280|NCT01376440|"~     The Millenium development goals (MDGs) call for reducing by half the proportion of people~     without sustainable access to safe drinking water. This goal was adopted in large part~     because safe drinking water has been seen as critical to fighting diarrheal disease. Source~     protection is considered the main intervention area to achieve this goal. However, research~     worldwide that has shown that even drinking water which is safe at the source is subject to~     frequent and extensive fecal contamination during collection, storage and use in the home.~     This contamination is through the introduction of cups, dippers or hands, contamination by~     flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can~     pose infectious disease risks if they become contaminated due to unsanitary collection,~     storage conditions and practices within households.~      To reduce this problem, point-of-use water treatment has been advocated as a means to~     substantially decrease the global burden of diarrhea and to contribute to the MDGs. However,~     research indicates that there are many unanswered questions around Household water treatment~     (HWT) that require small or medium scale epidemiological studies and randomized controlled~     trials, especially with regard to effectiveness, acceptability and identifying suitable~     target populations. Some of the most urgent questions to be resolved are:(1) How much of the~     currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on~     nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted?~     (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease~     is high.~      hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive~     children? hypothesis: Do household water treatment with chlorine acceptable in the~     community?~   "
128281|NCT01376427|"~     This study proposes to provide adequate treatment and is based on current scientific~     evidence for elderly patients with ALL Bcr / Abl positive.~      To determine whether low-dose chemotherapy associated with imatinib or dasatinib has~     acceptable tolerability in elderly patients.~      To determine whether this association can increase the rate and quality of referrals to the~     results of the literature of imatinib as monotherapy for elderly patients~   "
128282|NCT01376414|"~     This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori)~     colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban~     academic emergency department (ED) located in Washington, DC.~   "
128283|NCT01376401|"~     This protocol corresponds to an open-label national phase II, multicenter, to assess~     efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and~     prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease~     progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible~     for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and~     administration of two cycles BVP over followed by autologous transplant.~      In addition to the overall response rates, will also be analyzed time to progression (TTP),~     progression-free survival (PFS) and overall survival.~      Finally, the results will be compared with BVP with those obtained in 120 patients included~     in our protocol VMP GEM10MAS65.~      Patients will be evaluated at scheduled visits up to 3 periods of study:~      pretreatment, treatment and monitoring.~   "
128284|NCT01376388|"~     The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444~     Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry~     Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary~     Disease (COPD). This is a multi-centre, open-label study evaluating the safety of~     GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the~     morning. The target enrolment is approximately 120 subjects at approximately 20 study~     centres in Japan. The total duration of subject participation will be 54-55 weeks,~     consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up~     period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at~     screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided~     for completion of baseline safety evaluations and to obtain baseline measures of COPD~     status. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and~     enter the treatment period. This treatment will be delivered via the Novel Dry Powder~     Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of~     study medication. Subjects will be instructed to administer medication once daily in the~     morning for the duration of the 52-week treatment period. Each subject should be advised to~     adhere to this dosing regimen throughout the study. There will be a total of 8 study visits~     including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks,~     12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up~     (Visit 9) will be conducted by the phone contact approximately 1 week following the~     completion/withdrawal of treatment period. A subject will be considered to have completed~     the study upon completion of the last on-treatment visit (Visit 8). At the end of the~     treatment period, subjects will be prescribed appropriate COPD medication at the~     investigator's discretion.~   "
128329|NCT01375803|"~     This study will critically evaluate the effects of a novel dietary fiber administered to~     subjects at high risk for developing diabetes to determine if this intervention will improve~     insulin sensitivity compared to control product administration and, thus, decrease risk for~     developing diabetes.~      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will~     significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in~     pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at~     screening) compared to consumption of the control product.~   "
128330|NCT01375790|"~     This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.~      The principal hypothesis is that whole-body vibration training plus exercise improves the~     body balance and prevents falls more than only exercise training in institutionalized older~     people. The number needed of patients is 160 (80 per group).~   "
128285|NCT01376375|"~     Background:~      - Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate~     specific points in the body. Previous studies have found that acupuncture can be useful in~     treating low back pain. This study will explore how acupuncture affects low back pain.~     Researchers will look at blood samples for changes in different chemicals related to~     inflammation and pain.~      Objectives:~      - To test the effect of acupuncture on blood chemicals associated with chronic low back~     pain.~      Eligibility:~        -  People at least 18 years of age who have chronic low back pain.~        -  Those who have had back surgery or had acupuncture for any medical condition may not~          participate.~      Design:~        -  This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2~          hours.~        -  At the first study visit, participants will give a medical history and complete two~          questionnaires about their low back pain. They will also spend 30 minutes lying down on~          a bed, relaxing quietly.~        -  The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will~          receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic~          the standard procedure, but no needles will be used. The standard procedure will be~          performed in the same location. A licensed, experienced acupuncturist will insert small~          disposable needles into acupuncture sites on the back, arms, and legs. Those in the~          study will not know whether they are receiving the sham or the standard acupuncture~          procedure.~        -  At some visits, participants will provide blood samples for testing. At every visit,~          participants will complete the questionnaires about low back pain.~   "
128286|NCT01376362|"~     The objective of this study is to investigate the safety and efficacy of ocular~     instillations of interferon gamma-1b as a potential treatment for cystoid macular edema~     (CME) secondary to uveitis.~   "
128287|NCT01376349|"~     RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer~     survivors.~      PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to~     placebo in treating postmenopausal cancer survivors with vaginal symptoms.~   "
128288|NCT01376336|"~     Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may~     be transmitted via drinking water and are related to sanitation and hygiene. Previous~     research has suggested that safeguarding household drinking water against recontamination~     may be a critical intervention that can reduce risks of diarrheal diseases and may be~     especially important for people living with HIV/AIDS (PLWHA) and other vulnerable~     populations (Clasen et al. 2007). The investigators propose here a randomised, controlled~     trial of a household safe storage container for drinking water in a well defined,~     HIV-impacted population in peri-urban Lusaka, Zambia. After a baseline data collection~     period (9 months) half of all households (150 households) will be given a safe water storage~     container specifically designed to prevent recontamination of water in household use. All~     households will be followed for an additional 9 months. Results of this study will help~     determine whether this promising water quality intervention can reduce diarrhoea and related~     outcomes in this and similar vulnerable populations.~   "
128289|NCT01376323|"~     The aim of this combined, two part study is to evaluate the safety and glucose lowering~     effects of GSK256073 when administered to diabetic subjects for 12 weeks.~   "
128290|NCT01376310|"~     This is an open-label study which will permit subjects with solid tumors or leukemia, who~     are currently clinically benefitting on another GSK sponsored trial with GSK1120212 either~     monotherapy or in combination continued access to GSK1120212.~   "
128291|NCT01376297|"~     NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two~     antiemetic drugs, both given with oral dexamethasone. The objective of the study is to~     evaluate if netupitant and palonosetron are safe when administered to prevent nausea and~     vomiting after administration of repeated cycles of chemotherapy.~   "
128292|NCT01376284|"~     The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg~     collected from the required number of Japanese subjects with benign prostatic hyperplasia~     (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of~     its use at post-marketing clinical settings.~   "
128293|NCT01376271|"~     The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use~     in Japanese Social Anxiety Disorder (SAD) subjects.~   "
128294|NCT01376258|"~     Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be~     associated with improved clinical outcomes for patients with enlarged prostates (EP) and~     lower health care related costs.~      The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and~     length of therapy and the likelihood of acute urinary retention (AUR), prostate-related~     surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or~     prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and~     Medicare population. The null hypothesis is that no differences will be observed in the~     outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not.~     The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer~     period of time will experience significantly fewer adverse outcomes and significantly lower~     treatment costs.~      The data source for this analysis is the MarketScan database, which contains medical and~     pharmacy claims for commercial health plan members and Medicare recipients. Medical and~     pharmacy claims data are sourced directly from health plans and employers. The database~     represents approximately 18 to 20 million individuals annually and nearly 22 million~     Medicaid enrollees from multiple states. The database includes the Medicare-covered portion~     of payment, the employer-paid portion, and any out-of-pocket expenses paid by the~     beneficiary.~      The study design is a retrospective cohort analysis. Each patient's index date was defined~     as the date of the first fill for a 5ARI prescription.~   "
128295|NCT01376245|"~     The purpose of the study is to investigate the efficacy and safety of fluticasone~     furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period~     in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).~   "
128296|NCT01376232|"~     Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or~     an Inhibitor of CYP2C8 (gemfibrozil),]~   "
128331|NCT01375777|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG~     145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent~     change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.~   "
128297|NCT01376219|"~     The economic cost of asthma is considerable both in terms of direct medical costs (such as~     the cost of pharmaceuticals and hospital admissions) and indirect medical costs (such as~     time lost from work and premature death).~      The costs of asthma depend on the severity of disease and the extent to which exacerbations~     are avoided. Moreover, poor control of asthma symptoms is a major issue that can result in~     adverse clinical and economic outcomes.~      According to GINA guidelines, the goal of asthma treatment is to achieve and maintain asthma~     control. Such an objective can be reached in a majority of patients with a pharmacologic~     intervention strategy developed in partnership between the patient/family and the doctor.~     Validated measures for assessing asthma control score goals as continuous variables and~     provide numerical values to distinguish different levels of control. Among them, the Asthma~     Control Test (TM - QualityMetric Incorporated) is widely recognized. Few data exist on the~     relationship between asthma control and health care consumption.~      Some models for predicting asthma costs have been proposed. However, these models only~     attempt to assess costs associated with medications and/or asthma exacerbations.~     Furthermore, in such studies, asthma control was not defined accordingly to current~     international criteria.~      Considering the increasing interest of health authorities in reducing asthma associated~     costs and improving quality of care, it appears necessary to study the relationship between~     the cost and the level of control.~   "
128298|NCT01376206|"~     To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal~     Spray in Japanese subjects with allergic rhinitis under the practical use conditions~   "
128299|NCT01376193|"~     The study is designed to investigate the information on safety and efficacy of naratriptan~     tablets on Japanese subjects with migraine headache during Japanese post-marketing~     surveillance period.~   "
128300|NCT01376180|"~     The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to~     collect information for using lamotrigine tablet effectively and safely as well as to grasp~     onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women,~     subjects with poor renal and hepatic functions.~   "
128301|NCT01376167|"~     The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with~     Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the~     control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be~     co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the~     selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax~     Malaria.~   "
128302|NCT01376154|"~     The purpose of this study is to confirm efficacy and safety when administering lamivudine~     tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.~   "
128303|NCT01376141|"~     The study is designed to detect adverse drug reactions (particularly clinically significant~     adverse drug reactions) occurring in clinical settings, to examine factors likely to affect~     the safety and efficacy of sumatriptan tablet, and to discuss the need of special~     investigation and postmarketing clinical study.~      A special focus was placed on the investigation of occurrence of ischaemic heart~     disease-like events including arrhythmia, angina pectoris, and myocardial infarction in the~     present study.~   "
128304|NCT01376128|"~     The objectives of this survey was to retrospectively collect and evaluate the information on~     the efficacy and safety of PAXIL tablets (PAXIL, hereinafter) in pediatric subjects (aged~     under 18) with panic disorder under conditions of actual use.~   "
128305|NCT01376115|"~     To investigate safety and efficacy on Japanese subjects treated with nelarabine injection~     for intravenous use in clinical settings of the following diseases:~        1. T-cell acute lymphocytic leukemia (T-ALL)~        2. T-cell lymphoblastic lymphoma (T-LBL) Also, any adverse events involving neurological~          disorder, hypotension, and blood disorder and their details are to be investigated as~          an item of particular concern. In addition, subject outcome (alive or dead) at one year~          after the start of treatment will also be investigated.~   "
128306|NCT01376102|"~     This is an open label, multi-centre, non-interventional post-marketing surveillance~   "
128307|NCT01376089|"~     The purpose of this study is to evaluate and compare overall patient comfort profile between~     the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast~     media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed~     Tomographic (CECT) imaging of the abdomen/pelvis.~   "
128308|NCT01376076|"~     This study will evaluate the effects of sequential multiple dose regimens of cariprazine on~     cardiac repolarization in patients with schizophrenia.~   "
128309|NCT01376063|"~     The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on~     the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.~   "
128310|NCT01376050|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     as an adjunctive therapy to the healing of venous stasis leg ulcers.~   "
128311|NCT01376037|"~     The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light~     laser device can help to reduce the circumference of the upper arms.~   "
128332|NCT01375764|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG~     145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein~     cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective~     dose of a statin.~   "
128333|NCT01375751|"~     The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous~     evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in~     adults with heterozygous familial hypercholesterolemia (HeFH).~   "
128334|NCT01375738|"~     This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in~     patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood~     glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to~     evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in~     gastric cancer patients with diabetes.~   "
128335|NCT01375725|"~     The purpose of this study is to measure prothrombin time (PT) expressed in International~     Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an~     experimental device and a commercially available device. This study will involve taking a~     finger-puncture and testing onto a strip and meter system for the experimental and~     commercially available devices.~   "
128312|NCT01376024|"~     The study hypothesizes that there exist effective non-operative and operative treatments for~     certain patient populations with basal joint arthritis of the thumb. There also exists a~     functionally superior, cost effective, and low risk non-operative or minimally invasive~     operative treatment regime to alleviate pain and slow the progression of disease in those~     with less advanced disease. Likewise, there is significant functional, health utility, and~     economic advantage to surgically treating advanced basal joint arthritis with one of the~     popularized procedures currently in practice.~      Arthritis at the base of the thumb is a common condition associated with considerable~     patient discomfort. Many non-operative and operative treatments have been described, but few~     prospective studies involving multiple centers comparing these treatments have been done. By~     following patients from the start of their arthritis treatment and assessing their progress~     at certain time points using questionnaires and radiographs the investigators believe~     patient outcomes and satisfaction can improve. This study will include patients who are~     treated non-operatively and operatively and will not change patients' standard of care. By~     establishing standardized outcome measures and collecting data prospectively from the time~     of initial presentation through all treatment interventions it will be possible to directly~     compare treatments during the conservative and operative care of basal joint arthritis of~     the thumb. This multi-center study will identify those specific procedures or conservative~     treatments that have the greatest potential to be studied in subsequent focused and~     well-designed randomized control trials.~   "
128313|NCT01376011|"~     The purpose of this study is to find out if quercetin can increase blood levels of~     hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a~     corresponding increase in blood flow to the brain.~   "
128314|NCT01375998|"~     This study is a regulatory post marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received YAZ for dysmenorrhea. The~     objective of this study is to assess safety and efficacy of using YAZ in clinical practice.~     A total 3,000 patients will be recruited and followed 3 years since starting YAZ~     administration.~   "
128315|NCT01375985|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-7100, a candidate treatment for influenza.~   "
128316|NCT01375972|"~     To select a better agent between S-1 or gemcitabine in combination with cisplatin for the~     conventional chemotherapy platform for future development in advanced Biliary Tract~     Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and~     cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.~   "
128317|NCT01375959|"~     Resveratrol is a substance found in many plants, including grapes and red wine, which is~     widely used as a nutritional supplement. Studies in cells and lower animals show that~     resveratrol has many potential benefits, including prolonging lifespan, preventing cancer~     and heart disease and normalization of glucose metabolism. Although use of this agent shows~     great promise in the treatment and/or prevention of diabetes, there have been no studies~     reported to date in humans. As an initial step, this proposal is for a 6 week pilot study of~     resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to~     explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be~     conducted to explore how resveratrol works by studying cellular function (in muscle samples~     obtained from study participants) and by testing resveratrol's effect on blood vessel~     function.~   "
128318|NCT01375946|"~     A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal~     delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and~     external conditions of heat, humidity, cold water and exercise.~   "
128319|NCT01375933|"~     The purpose of this study is to assess the comparability of the phase 3 lot and a single~     commercial lot of NicVAX in healthy smokers.~   "
128320|NCT01375920|"~     Depression is one of the most common mental health problems, with at least one in six adults~     suffering from this at some time in their life. It can become long-lasting and frequently~     recurs. Depression has a large negative impact on quality of life of patients and their~     carers and it has also been shown to be one of the leading causes of working age adults~     receiving disability payments in the UK. The need for improved treatment has been recognised~     by the Department of Health and others. Improvements in drug treatments are therefore~     required. There has been recent increased understanding of some of the causes of the~     frequent lack of complete response seen with antidepressants. The stress hormone, cortisol,~     is often elevated or poorly controlled in depression and there is laboratory and clinical~     research to show that this hormonal change reduces the benefits from antidepressants with~     associated poor outcome and memory problems. Recently it has been shown in small studies~     that giving treatments that reduce cortisol or block its harmful effects for between 1 and 3~     weeks overcome these negative consequences. Our group is particularly interested and~     experienced in this topic. The investigators plan to study a drug that decreases cortisol~     levels in people who have not recovered with standard antidepressants so that the~     investigators can find out the usefulness of this treatment (compared with placebo (dummy~     tablet)) in day to day life as well as checking closely for side-effects (the initial~     studies have shown that the particular drug the investigators wish to study (metyrapone) has~     few side effects). The investigators will also measure cortisol and see if its level can~     tell us which people do best with this treatment. The investigators will carry out this~     study in 3 centres across the UK. The investigators will carry out some additional tests of~     specific sorts of memory and decision making and also do this while scanning the brain (in a~     painless test). The results of these tests, along with tests of brain wave patterns, should~     help us understand more fully how this new treatment is working and who responds best to it.~     The study will help us find out if this drug should be used more widely for people not~     responding to standard treatments and will also lead on to the development of other new~     treatments with an anti-cortisol effect to help tackle the major problem of poor outcome~     from depression.~   "
128321|NCT01375907|"~     The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for~     Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in~     Vietnam.~   "
128336|NCT01375712|"~     The objective of this study is to evaluate if consumption of fermented milk containing~     Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency,~     constipation-related symptoms, and quality of life in subjects who frequently have hard or~     lumpy stools.~   "
128337|NCT01375699|"~     Sildenafil increases the therapeutic effect of doxorubicin used as treatment for cancers of~     solid tumors through both an increase in anti-tumor effects and protection from cardiac~     toxicity.~   "
128401|NCT01374828|"~     Pain control following surgery is a critical aspect of patient care. Pain at incision sites~     in laparoscopic surgery contributes to overall pain felt by a patient. There is no~     definitive proof that the typical medications (such as lidocaine) injected at incision sites~     during surgery improve pain control. This study looks at a different type of medication~     (ketorolac - an NSAID) to better control pain at laparoscopic incision sites.~   "
128322|NCT01375894|"~     The ability to understand the other's perspective and respond accordingly is the most~     important normal process of daily social life and is probably one of the foundations of~     human existence. This capability is reflected, inter alia, as an imitation - an important~     and effective form of learning which is very developed in humans. When we are required to~     imitate a particular movement, speed of response depends on the perspective of the movement.~     Imitative response is implemented faster when the movement is observed from first-person~     perspective, than if the motion is presented from the perspective of a third party.~      While healthy individuals don't find it difficult to imitate, or to understand the other's~     emotion expression, there are psychiatric populations (such as autism and schizophrenia) who~     find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond~     these capabilities impairment, schizophrenic patients have difficulty distinguishing between~     their arm movements and those of a foreign hand and find it difficult to leave the~     boundaries of egocentric interpretation of reality and adopt the other's point of view.~     These behavioral disorders arise from defects in the network of mirror neurons (Buccino and~     Amore 2008; Langdon, Coltheart et al. 2010).~      Therefore, the investigator expect that schizophrenic patients will not see a preference for~     movements that will be displayed in first-person perspective from the same movements that~     will be displayed from the perspective of a third party. Consequently, the investigator~     speculate that these subjects will not exhibit differences at imitating the response of~     which will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.~   "
128323|NCT01375881|"~     The purpose of this non-interventional study is a description of use of darunavir in daily~     practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual~     manner and in accordance with the terms of marketing authorization. The assignment of a~     patient to a particular therapeutic strategy will not be decided in advance by this study~     protocol but instead, it will be part of the current clinical practice. The prescription of~     the medicinal product will be clearly separated from the decision to include the patient in~     the study. No additional diagnostic or monitoring procedures will be applied to the~     patients, and epidemiological methods will be used for the analysis of collected data. After~     having agreed with the patient on starting treatment with darunavir, and provided that all~     inclusion and exclusion criteria apply, the physician will document the patient's data.~     Patients will be observed for at least 48 weeks from baseline visit except for those who~     withdraw from the study earlier. Patients data will be collected at approximately 0, 1, 3~     and 6 months after starting treatment and subsequently every 3 months in accordance with~     routine practice. The expected number of patients to enroll is about 900. The patients will~     be treated with darunavir according to the Italian label. The patient must be withdrawn from~     the study if the treatment with darunavir has been stopped. A last evaluation must be~     documented when possible, and a resistance test will be collected if available for patients~     discontinuing for virologic failure. At the end of study visit, information on therapy given~     after darunavir discontinuation will be collected. For patients discontinuing for virologic~     failure, data will be collected until the end of the present study, and at least two~     consecutive measurements of viral load after starting new antiretroviral therapy will be~     collected, if available. All data collected must be the result of the normal medical care of~     the patient. The patient's baseline data will be collected within the first week before~     darunavir administration (at Visit 1). For patients already in treatment with darunavir,~     baseline and follow up data will be collected retrospectively and prospectively. Further~     data collection will occur approximately at 1, 3, and 6 months and subsequently about every~     3 months according to routine practice, after initiating darunavir treatment.~   "
128324|NCT01375868|"~     Vaccines against human papillomaviruses are now commercially available. One of the~     commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of~     RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well~     as its effectiveness in prevention of incident and persistent infection of the vaccinal~     types as well as a development of lesions caused by these types. After vaccination the~     antibodies level increases dramatically and the high levels of antibodies are present in the~     blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal~     antigens have been detected in the cervical mucus of vaccinated women. The preliminary data~     are now available showing the presence of HPV-specific antibodies in the oral cavity in~     women after vaccination. The level of antibodies has been dependent on time since~     vaccination.~   "
128325|NCT01375855|"~     Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent~     implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion~     (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by~     means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months~     follow-up. The investigators sought to compare the two stent types with the same drug to~     verify the polimer role. The polimer itself seems to provoke inflammation and~     hypersensibility if the arterial wall and it seems to be the base of a process of positive~     remodeling found at drug eluting stent implantation site.~      This positive remodeling is the mechanism producing late stent malapposition which on its~     turn can determine stent thrombosis, as demonstrated by pathological studies. At the same~     time the investigators will study the incidence of clinical events like myocardial~     infarction, stent thrombosis, TLR and death along with the incidence of angiographic~     restenosis at 2 years follow up.~   "
128326|NCT01375842|"~     This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate~     the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as~     single agent by intravenous (IV) infusion every three weeks (q3w) to participants with~     locally advanced or metastatic solid malignancies or hematologic malignancies. The study~     will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.~   "
128327|NCT01375829|"~     This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in~     treating patients with solid tumors that have spread from the primary site to other places~     in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as~     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving ixabepilone together with temsirolimus may kill more tumor cells.~   "
128328|NCT01375816|"~     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan~     hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. It is not yet known whether giving liposome-encapsulated irinotecan~     hydrochloride PEP02 together with leucovorin calcium and fluorouracil is more effective than~     giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as~     second-line therapy in treating patients with metastatic colorectal cancer.~      PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan~     hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well~     it works compared with giving irinotecan hydrochloride together with leucovorin calcium and~     fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.~   "
128338|NCT01375686|"~     The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision~     and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The~     study will involve up to two unique Scout devices at each clinical site. Each site will~     initially contain only a CS-1 (Commercial SCOUT 1) A for collection of data. As they~     become available, CS-1 Bs operating with latest version of SCOUT software will be shipped~     to each site.~      The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study~     inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately~     9 clinical sites distributed across the United States. Eligible subjects must be at least 18~     years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must~     have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.~      The data will be collected and a partial area under the receiver operator curve (pAUC) will~     be computed via the method of moments between the 20% and 50% false positive rates based on~     the first valid Scout A measurement for each patient. The impaired glucose tolerance~     status will be determined by the average of the two hour, post challenge plasma glucose~     samples measured at the central laboratory. This will be compared to 1000 bootstrap~     re-samplings of the calibration data pulling a cohort that matches that collected during~     this study. A test will be conducted to assure that the SCOUT performance lies within a 95%~     empirical confidence interval based on the bootstrap re-sampling.~   "
128339|NCT01375673|"~     Heart Failure (HF) is a significant healthcare concern in the US, with a 120% rise in~     mortality rates over 15 years costing the country an estimated $37.2 billion in 2009.~     Veterans are currently impacted at a rate of 5.2%, and cost an average of~     $14,959/individual/year for those utilizing the VA's Healthcare services. Research has shown~     that exercise training (ET) improves aerobic capacity, endothelial dysfunction, quality of~     life, and the ability to tolerate activity within the overall HF population. The purpose of~     this study is to examine the effects of structured exercise training and specific types of~     exercise training, walking, bicycling, and resistance training, on the symptom of fluid~     volume over load or edema in advanced heart failure patients.~   "
128340|NCT01375660|"~     This study will supplement African American male (AAM) veterans at risk for diabetes and~     newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D~     helps to improve early markers of diabetes. The study will be done at Veteran Administration~     Medical Center in Chicago.~   "
128341|NCT01375647|"~     Oral polio and rotavirus vaccines are significantly less effective in children living in the~     developing world. Tropical enteropathy, which is associated with intestinal inflammation,~     decreased absorption and increased permeability, may contribute substantially to oral~     vaccine failure in developing country settings. Other possible causes of oral vaccine~     underperformance include malnutrition, interference with maternal or breastmilk antibodies,~     changes in gut microbiota, and genetic susceptibility.~      Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral~     polio and rotavirus vaccines in children in Bangladesh.~      Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost~     on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus~     vaccine to prevent rotavirus diarrhea~      The polio and rotavirus randomized clinical trials are embedded as secondary objectives~     within the exploratory study of tropical enteropathy. The primary and secondary outcome~     measures are relevant to the randomized clinical trials.~   "
128342|NCT01375634|"~     Nasogastric tube placement involves insertion of a flexible tube through the nose into the~     stomach. Placement of the tube can irritate the nose and palate and trigger gagging, causing~     discomfort, even if topical or local anesthetics are used. This study aims to determine if~     administration of an ultra-short acting sedative agent (midazolam) into a vein before the~     procedure, in addition to topical local anesthetic, will decrease the level of discomfort.~   "
128343|NCT01375621|"~     Background:~      - MRSA is a type of bacteria that causes serious health problems. It can cause severe~     infections and is difficult to treat. MRSA has been found in a high number of people who~     work with some kinds of livestock, such as pigs. Researchers want to study people in rural~     areas, where more people work with or around livestock. They want to see if MRSA is more~     common or causes more serious infections in these areas.~      Objectives:~      - To look at the relationship between livestock handling (especially pigs) and MRSA bacteria~     in people in rural areas.~      Eligibility:~        -  Participants in the Agricultural Health Study in Iowa, including those who are exposed~          to livestock.~        -  Healthy volunteers who are not exposed to livestock.~      Design:~        -  This study requires an initial visit and monthly follow-up surveys for 18 months.~        -  At the first visit, participants will have throat and nose swabs to collect cell and~          bacteria samples. They will also complete a questionnaire about their health habits.~          Other questions will ask about any work that brings them into contact with livestock~          like cows, pigs, or chickens.~        -  Every month for the next 17 months, participants will complete another questionnaire to~          record any changes in their health and livestock contact information. They will also~          collect throat and nose swabs. They will send the questionnaires and the swabs to the~          study researchers.~        -  Participants will be paid for the first visit and for every monthly survey and swab~          collection they return.~        -  No treatment will be given as part of this protocol.~   "
128344|NCT01375608|"~     Background:~        -  In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do~          not behave normally. In parts of the body where there are low levels of oxygen or where~          oxygen is used more, the sickle hemoglobin proteins may change shape and stick~          together. This causes the red cells to clump, which reduces blood flow. This leads to~          even lower oxygen levels and causes damage and/or pain.~        -  One way to stop the red blood cells from sticking together is to increase the levels of~          fetal (baby or good ) hemoglobin. The good hemoglobin then takes the place of the~          sickle hemoglobin.~        -  Hydroxyurea is the only approved drug for SCD. But hydroxyurea works in only about~          two-thirds of people with SCD. Even in those cases it sometimes stops working over~          time.~        -  Researchers are interested in testing decitabine. The drug may help to increase fetal~          hemoglobin levels. But it has not yet been approved to treat SCD.~      Objectives:~      - To test the safety and effectiveness of decitabine in increasing fetal hemoglobin levels~     and improving the symptoms of sickle cell disease.~      Eligibility:~      - People at least 18 years of age who have sickle cell disease that has not improved after~     at least 6 months of hydroxyurea therapy. Those who cannot take hydroxyurea because of side~     effects may also participate.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood and urine tests, a lung function test, and other tests as required.~        -  Participants will receive decitabine injections up to twice a week for 1 year.~          Depending on the response to treatments, the dose will remain the same or be reduced to~          once a week.~        -  Participants will be monitored with frequent blood tests and other studies as directed~          by the study doctors.~        -  After the study is completed, participants will go back to their usual sickle cell~          care. If decitabine has improved a participant's SCD, treatment may be continued under~          regular health coverage insurance if this can be arranged.~   "
128345|NCT01375595|"~     Background:~      - Studies have shown that animals such as monkeys and dogs have excellent sight and touch~     memory but perform poorly on sound memory tasks. Human brains have certain areas that are~     important for speaking and understanding language. These areas may be involved in sound and~     spoken word memory. Researchers want to study these areas of the brain to find out if the~     memory for sounds requires brain structures that are usually associated with language~     learning and are unique to humans.~      Objectives:~      - To use magnetic resonance imaging to study areas of the brain involved in sound memory.~      Eligibility:~      - Healthy right-handed volunteers between 18 and 50 years of age. They must be native~     English speakers and have completed high school.~      Design:~        -  The study requires a screening visit and 1 or 2 study visits to the National Institutes~          of Health Clinical Center.~        -  At the screening visit, volunteers will have a medical history taken. They will also~          have physical and neurological exams, and complete a questionnaire. Women of~          childbearing age will give a urine sample. Participants who have not had a magnetic~          resonance imaging (MRI) scan in the past year will have one at this visit.~        -  At the second visit, participants will have tests of sound memory. They will listen to~          a set of nonsense words spoken through earphones and memorize the words. Then they will~          listen to the words again to judge if the words were part of the earlier list.~          Participants will have a 1 hour break, then do the sound memory test again. During the~          second test they will have repetitive transcranial magnetic stimulation (rTMS), which~          stimulates different regions of the brain.~        -  If the group results from the testing sessions are positive, there will be a third~          visit. At this visit, participants will have a sound perception test. They will listen~          to words spoken through earphones and judge whether the words in the pair are the same~          or different. Participants will have rTMS during these tests as well.~   "
128346|NCT01375582|"~     This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.~   "
128347|NCT01375569|"~     Background:~      - TRC105 is an experimental cancer drug. It is designed to slow or stop the growth of~     tumors. It does this by preventing the growth of new blood vessels that feed these tumors.~     People with hepatocellular carcinoma (or liver cancer) sometimes do not respond to standard~     treatments. This includes the cancer drug sorafenib.~      Objectives:~      - To test the safety and effectiveness of TRC105 to treat liver cancer that has not~     responded to standard therapy.~      Eligibility:~        -  People at least 18 years of age who have hepatocellular carcinoma (or liver cancer)~          that has not responded to standard therapy. Participants also will not be eligible for~          a liver transplant.~        -  No anticoagulation therapy is allowed with the exception of low-dose aspirin.~        -  No history of bleeding disorders, peptic ulcer disease or gastritis.~      Design:~        -  Participants will have a physical exam and medical history. They will also have blood~          and urine tests, and imaging studies.~        -  Participants will receive TRC105 once a week. They will also have two daily doses of a~          steroid the day before each treatment. This will help prevent known side effects.~        -  Participants will be monitored with blood and urine tests. They will also have imaging~          studies every two months to study the effect of the drug on tumor growth.~        -  Participants will continue to have TRC105 as long as they do not have severe side~          effects and their liver cancer stops growing or shrinks. After stopping TRC105, they~          will have yearly visits with physical exams and blood tests.~   "
128348|NCT01375556|"~     Background:~      - Previous research has shown that a person s genes can influence how they respond to~     alcohol. But researchers do not yet know all the genes that might be involved.~      Objectives:~      - To identify genes that are related to how non-alcoholic individuals respond to alcohol.~      Eligibility:~      - Healthy people between 21 and 30 years of age who have no history of alcohol or drug~     dependence.~      Design:~        -  The study requires one or two 9-hour visits to the National Institutes of Health~          Clinical Center.~        -  Participants must not take any medicines (except birth-control pills for women) for at~          least 3 days before the visit. They must not drink alcohol for at least 2 days before~          the visit.~        -  Screening includes a medical history, physical exam, and a urine test for drugs of~          abuse.~        -  Participants will be given alcohol over about 2.5 hours. This will have about the same~          effect as having three to four drinks. Frequent breathalyzer tests will check breath~          alcohol level during the infusion.~        -  Before and during the infusion, participants will complete questionnaires about mood~          and feelings. Other tests will study thinking, balance, judgment, and risk-taking.~          Blood samples will be collected four times during the infusion.~        -  Participants will have breakfast at the start of the visit (around 8:00 AM). They will~          have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be~          served after the alcohol infusion is complete (around 2:20 PM). After the tests, those~          in the study will have to stay in the Clinical Center until their breath alcohol level~          falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at~          that time. Participants will not be able to drive themselves home after the study~          visits. Also, they should not take any medicines or operate any machinery for at least~          2 hours after leaving NIH.~   "
128349|NCT01375543|"~     Background:~      - The purpose of this study is to identify changes in genes that cause human diseases. We~     would like to obtain some of you or your child s DNA and test for changes in genes that may~     contribute to a disease in you or your family.~      Objective:~      -To allow for exomic or genomic sequencing of NICHD patients or family members in order to~     identify changes in genes that cause or contribute to a specific disease.~      Eligibility:~        -  Children who are enrolled in an NICHD clinical study where the condition being studied~          may have a genetic cause.~        -  Family members of a child who is eligible for this study.~      Design:~        -  Children and family members will supply DNA samples. If the samples are already~          available, no further DNA will be needed.~        -  If DNA is not available, samples of either blood or skin will be taken.~        -  We will use these samples with new DNA sequencing technology that looks at all the~          human genes we know about. This is known as exome and genome sequencing.~   "
128350|NCT01375530|"~     Background:~      - The National Institute of Allergy and Infectious Diseases (NIAID) at the National~     Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will~     allow researchers to study vaccines and injection devices. These studies will also allow~     researchers to understand the immune system and how vaccines work. In this protocol,~     researchers will screen healthy volunteers for these future trials.~      Objectives:~      - To screen healthy volunteers for clinical trials at the NIAID.~      Eligibility:~      - Healthy people between 18 and 70 years of age. They must be available to take part in~     clinical trials and be able to provide blood for research studies.~      Design:~        -  Screening for a clinical trial may begin several months before the vaccine clinical~          trial begins.~        -  Volunteers will be screened with a physical exam and medical history. They may also~          answer questions about sexual activity and drug use.~        -  Volunteers will provide blood samples and possibly urine samples. They may have other~          tests as needed for the study.~        -  Volunteers will not receive any treatment in this screening trial.~   "
128351|NCT01375504|"~     This study is designed to assess the effect of a mindfulness training program with special~     focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and~     their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled~     trial.~   "
128352|NCT01375491|"~     Obesity is a heightened state of inflammation in which production of cytokines and matrix~     metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin~     resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will~     enhance insulin sensitivity and decreases inflammation in obese participants with type 2~     diabetes (DM2).~   "
128356|NCT01375439|"~     Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to~     10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous~     pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy,~     premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved~     in Neonatology, morbidity and mortality resulting from high rates of preterm births have~     remained constant in the last few decades. Objective: This study aims at evaluating maternal~     and perinatal outcomes of pregnant women with a history of preterm labor in previous~     pregnancies and submitted to active search for vaginal infection. Material and Method: It is~     a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups~     (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history~     of preterm childbirth. G1 will be related to the active search and etiological diagnosis of~     lower genital tract infections, and G2 will be related to non-search for such infections,~     for which the routine care protocol of primary health units in the city of Botucatu will be~     maintained. Care propedeutics for the pregnant women (G1) will include the performance of~     direct examination of vaginal content stained by the Gram method, culture in Diamonds~     medium, polymerase chain reaction (PCR) of endocervical secretion collected in the primary~     health care services in the city at two moments: prior to the 20th gestational week (M1) and~     at the 36th week (M2). Moment M3 will take place after childbirth for evaluation of the~     perinatal outcome.~   "
128357|NCT01375426|"~     Over a period of years there have been numerous reports from many developing countries~     including Pakistan showing a rising treatment failure rate with first line drugs~     (amoxicillin and cotrimoxazole) in non-severe pneumonia in children. The reasons for this~     rise in treatment failure rates are not entirely clear but one of the reasons is thought to~     be increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line~     drugs. There is microbiological data which suggests that this resistance can be overcome by~     increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia~     with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure~     rates. This will be a multicentre, double blind randomized controlled trial in children 2-59~     months of age with non-severe pneumonia comparing the clinical outcome between the standard~     and double dose groups.~      It has been felt that the WHO criteria for treatment failure in children with pneumonia are~     too stringent and have never been systematically evaluated in the community. The~     investigators also propose to modify WHO criteria and field test them in this trial in an~     attempt to demonstrate that less stringent treatment failure criteria would have an impact~     on the overall treatment failure rates in pneumonia.~      Hypothesis:~      Therapy outcome with double dose of oral amoxicillin is not different than the standard dose~     of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59~     months old children.~   "
128358|NCT01375413|"~     The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD).~     Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will~     not compromise safety. In the proposed study we will therefore collect high level evidence~     on whether 6 weeks of integrated dual task gait training is more effective than consecutive~     task practice. The investigators will use a randomized, single blind study design and~     conduct the same protocols in two academic centers (Katholieke Universiteit Leuven and~     Radboud Universiteit Nijmegen). The investigators intend to test an experimental condition~     which consists of focused dual task training in the home using a novel program of~     personalized cognitive tasks. The aim of dual task training is to teach motor-cognitive task~     integration and achieve optimal levels of automaticity and functionality. The control arm~     will receive gait practice and separate cognitive training of the same intensity, but~     offered consecutively. We will test the hypothesis that dual task training (integration)~     will have more pronounced effects on complex gait than consecutive task training.~      Sub-analysis will be conducted on patients with and without freezing of gait. The~     investigators expect that integrated dual task training may be less effective in patients~     with freezing, due to the increased fall risk and impaired cognitive profiles.~      Overall, this project will provide evidence to support future directions for motor learning~     and innovative rehabilitation targets.~   "
128359|NCT01375400|"~     Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The~     investigators would like to study laboratory effect of the first oral 300 mg dose of~     aspirin, given at hospital, after an ischemic event.~      The principal hypothesis is that platelet activity would be able to recover during this day~     and could lead to ischemic recurrences.~      Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23~     hours after. Photometric aggregometry are performed with arachidonic acid and collagen~     induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.~   "
128360|NCT01375387|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in~     healthy male Chinese and Japanese subjects.~   "
128361|NCT01375374|"~     The purpose of the trial is to investigate whether changes in lipids and hormonal parameters~     can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment,~     while Levetiracetam treatment remains unchanged.~   "
128362|NCT01375361|"~     This is a randomized trial of the use of Albuterol in the setting of acute decompensated~     Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.~   "
128363|NCT01375348|"~     Patients with chronic pain can experience considerable changes in their cognitive function~     such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and~     morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead~     to worsening of the cognitive function. The interaction between pain, treatment and~     cognitive function is very complex and is far from understood.~      The hypothesis of the present study is that by use of experimental pain in healthy~     volunteers it will be possible to elucidate the interaction between pain, treatment and~     cognitive function.~   "
128364|NCT01375335|"~     The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly~     intact contraction of the heart. This study aims to elucidate the efficacy of low-dose~     dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.~   "
128365|NCT01375322|"~     The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP)~     to 16-week regimen between Amtrel® and Co-Diovan®. The secondary objectives were listed as~     the following.~        -  To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end~          of study~        -  To evaluate the change from baseline in albumin-to-creatinine ratio with~          antihypertensive medications in whole group (combined treatment groups) and each~          treatment group (Amtrel®, Co-Diovan®) at Week 16~        -  The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16~        -  The change from baseline in fasting plasma glucose (FPG) at Week 16~        -  The change from baseline in fasting lipid profiles (triglyceride, total cholesterol,~          high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16~        -  The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity~          (ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16~        -  The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each~          specified study time point~        -  To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE,~          and laboratory examinations~   "
128366|NCT01375309|"~     Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal~     intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm~     infants who received Bifidobacterium bifidum early after birth. In order to evaluate these~     beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is~     conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to~     preterm infants improve enteral feeding and growth in very low birth weight infants.~   "
128367|NCT01375296|"~     Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with~     significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary~     syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and~     the effect of SES in these patients remains unclear. Here the investigators hypothesize that~     application of China-made SES may improve the clinical outcomes in these setting.~   "
128368|NCT01375283|"~     This is a prospective observational cohort study on changes in sensory mapping.~   "
128369|NCT01375270|"~     Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory~     function of the pancreas. This is known as glucolipotoxicity. However, few studies have~     examined this in detail. This investigation will examine pancreatic insulin secretory~     function in physiological models of glucolipotoxicity such as obese and type 2 diabetic~     individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or~     Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response~     to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal~     ingestion, will be examined. the investigators hypothesize that experimental~     glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that~     seen in type 2 diabetics.~   "
128370|NCT01375257|"~     Background Current management of infective endocarditis include admission and treatment with~     parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of~     present management strategy make it highly relevant to seek for alternative more lenient~     alternatives. Experiences with oral treatment are only sporadically described, but~     observational data suggest that oral treatment could be a feasible option. The investigators~     have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100%~     success rate.~      Study design The POET study is a Danish multicenter, prospective, randomized, open label~     study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics~     of endocarditis compared to full parenteral treatment. Stable patients (n=400) with~     streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve~     will be included. After a minimum of 10 days of parenteral treatment, patients will be~     randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment~     have been developed based on expected minimal inhibitory concentrations and pharmacokinetic~     calculations. Patients will be followed for 6 months after completion of antibiotic therapy.~     The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery,~     embolic events and relapse of positive blood cultures with the primary pathogen.~   "
128371|NCT01375244|"~     The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets~     and IPR Pharmaceuticals, Inc. Zestril (R).~   "
128372|NCT01375231|"~     The investigators posit that it would be advantageous to reproduce the height of the entire~     patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its~     preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient.~     For example the quadriceps mechanism would have to work harder if the total patellofemoral~     (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may~     occur if the overall PF height is increased. The investigators theorize that either of these~     sizing errors could lead to anterior knee pain. The purpose of this study is to compare the~     clinical outcomes between two surgical techniques: 1) a technique of reproducing the total~     PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of~     reproducing only the patellar thickness on one side of the joint (Group 2).~   "
128373|NCT01375218|"~     The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction~     brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip~     (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace~     and the Pavlik harness. The investigators hope to learn which brace treatment is best for a~     definable population so the appropriate brace can be chosen initially avoiding the time,~     expense, and frustration of a failed technique.~   "
128374|NCT01375205|"~     The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on~     babies' skin versus Johnson & Johnson baby lotion and skin cleanser.~   "
128375|NCT01375179|"~     This study is designed as a proof of concept of KRP203 for induction of remission in~     ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203~     in subjects with moderately active refractory ulcerative colitis.~      The study will provide safety and tolerability data in this subject population up to eight~     weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a~     clinical response to KRP203 by following up responding subjects for an additional 12 weeks.~   "
128376|NCT01375166|"~     The prevalence of diabetes is increasing and the management of the disease is nowadays~     considered a major challenge. Affected patients have increased mortality and morbidity as~     well as a significant drop in the quality of life. The complications of diabetes can be~     classified as microvascular (e.g. nephropathy, neuropathy or retinopathy) or macrovascular~     (e.g. cardiovascular or cerebrovascular).~      Several large-scale epidemiologic studies indicating that wider retinal venous caliber is~     strongly associated with the fasting glucose level as well as with diabetes. Another retinal~     vascular abnormality that is associated with diabetes is an abnormal retinal vascular~     response to flicker stimulation. Retinal vessel dilatation in response to stimulation with~     diffuse flicker light occurs due to a phenomenon called neurovascular coupling. This means~     that increased activity of neurons is associated with an increased retinal metabolism. This~     leads to a release of endogenous vasodilator substances and increased blood flow. However,~     previous studies were limited by the fact that retinal vessel diameters and blood flow were~     not measured simultaneously.~      The present study aims to investigate whether the response of retinal vessel diameters and~     blood flow velocities to flicker stimulation is altered in patients with diabetes. Both~     parameters will be measured in real time using Fourier Domain Doppler OCT.~   "
128377|NCT01375153|"~     Chronic heart failure is accompanied by anorexia and increased release of B-type natriuretic~     peptide (BNP) from the ventricular myocytes. The pathophysiological mechanisms linking heart~     failure and appetite-regulation remain unknown. This study aims to examine the impact of~     exogenous BNP administration on subjective ratings of hunger and satiety, and on~     appetite-regulating hormones in a placebo-controlled cross-over study performed in ten~     healthy human volunteers.~   "
128378|NCT01375140|"~     The goal of this clinical research study is to learn if the combination of ruxolitinib and~     lenalidomide can help to control MF. The safety of this study drug combination will also be~     studied.~      Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF~     cells from sending signals that may lead to the growth of cancer cells.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~   "
128379|NCT01375127|"~     This is an observational study designed to collect follow-up clinical date on subjects who~     were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued~     treatment prematurely or did not elect to enroll in long-term extension studies.~   "
128380|NCT01375114|"~     The goal of this clinical research study is to learn if panax ginseng (commonly called~     ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and~     mood changes in patients with cancer. The safety of ginseng will also be studied.~   "
128381|NCT01375101|"~     Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an~     immunologic etiology ,which has number of different clinical forms. Alternative natural or~     herbal origine drugs with antioxidant and anti-inflammatory properties have been used~     individually or in combination with systemic corticosteroids in order to decrease adverse~     drug reactions.~      This study was conducted to evaluate the effect of quercetin on treatment of erosive~     -atrophic lesions of oral lichen planus (OLP).~   "
128382|NCT01375088|"~     The purpose of this study is to determine whether propolis is effective in the treatment and~     prevention of radiotherapy induced oral mucositis.~   "
128383|NCT01375075|"~     The purpose of this study is to determine if 12 weeks of treatment with LY2484595~     administered as a monotherapy will significantly increase high-density lipoprotein~     cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese~     participants.~   "
128384|NCT01375062|"~     The purpose of this study is to isolate and culture stem cell from adult human testicular~     biopsies for future transplantation in fertility preservation.~   "
128385|NCT01375049|"~     This is an open-label, multi-center study in pediatric patients age 3 months to less than 18~     years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary~     colonization/infection. All eligible participants will be treated with a 28-day course of~     Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study~     drug, subjects will be followed up through Day 196 for safety and recurrence of PA.~      The primary objective is to evaluate the proportion of participants with PA-negative~     cultures at all time points during a 6-month monitoring period (through Day 196) after~     cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28~     (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months~     after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).~   "
128386|NCT01375036|"~     This is a prospective, longitudinal, 5-year study that will enroll participants from the~     existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will~     provide samples for microbiological evaluation, obtained upon enrollment and then once per~     year thereafter for 5 years.~   "
128387|NCT01375023|"~     The purpose of this study is to evaluate the engraftment, toxicity and anti-tumour activity~     of allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG~     conditioning regimen in patients with refractory Triple Negative breast cancer.~   "
128388|NCT01375010|"~     The purpose of this study is to determine the effects of vitamin D on measures of bone~     health and immune function in HIV infected postmenopausal women. The investigators prior~     research with this population revealed that low vitamin D levels are very common. Prior~     research with this population also revealed that Vitamin D is necessary for the body to~     absorb calcium and is important for the health of the bones. When vitamin D levels are low,~     there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of~     vitamin D have also been associated with impaired immune function. This study will help us~     learn whether two different doses of vitamin D will improve bone health and immune function.~   "
128427|NCT01374477|"~     Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy,~     being a serious health problem around the world.~      Previous studies have suggested that there is an association between a short period of~     exposure to paternal sperm of a new sexual partner and the development of an immunological~     reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to~     study the relationship between the primipaternity concept (exposure to male antigens present~     in semen over a short period of time previous to the pregnancy) and the development of~     preeclampsia in adolescents.~   "
128389|NCT01374997|"~     Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called~     alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function~     properly. As a result, the lipid accumulates in the body, this leads to multisystem~     impairment, including progressive renal failure.~      Several studies have focused on the detection of this disease in end-stage renal failure~     patients, transplant or hemodialysis.~      This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a~     glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90~     and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine~     level greater than 0,5 g/l.~      This screening will be conducted by a blood test to measure the level of alpha-galactosidase~     A activity by micromethod from samples taken from blood spots on filter paper. If this assay~     was positive, confirmation of diagnosis of Fabry disease will done the standard method:~     macrodosage of leukocytic alpha-galactosidase A activity.~      This multicenter prospective study, openly contacted in medical practice, with patient~     follow-up corresponding to the management of renal insufficiency, will be offered to all~     departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.~      The objective of this study is to assess the prevalence of Fabry disease in the target~     population and to identify previously undiagnosed patients, enabling them to benefit from~     appropriate management of their disease, including whether need enzyme replacement therapy.~   "
128390|NCT01374984|"~     This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia~     Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications~     resulting from smallpox vaccination in eligible patients treated with VIGIV.~   "
128391|NCT01374971|"~     The purpose of this study is to conduct an Investigator-Sponsored Study to determine the~     potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of~     disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre~     treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.~   "
128392|NCT01374945|"~     Use of Clearpath to facilitate successful completion of colonoscopy procedures with~     sub-optimal preparation.~   "
128393|NCT01374932|"~     The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a~     before/after Continuous Positive Airway Pressure (CPAP) assessment in participating~     patients. It aims to answer the following question: Is there an improvement in asthma in~     those patients with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with~     CPAP after six months?. It is hypothesized that treatment of OSAS with CPAP in patients with~     both OSAS and asthma concommitantly, may have a beneficial effect also on asthma outcomes.~     This clinical effect in asthma could be assessed objectively by applying validated~     questionnaires for quality of life and asthma control.~   "
128394|NCT01374919|"~     The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology~     Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020~     mg) administered via infusion pump over 15 minutes.~      To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing~     observation period.~      Assess additional safety profile and laboratory assessment at follow up visit and interim~     telephone follow up.~   "
128395|NCT01374906|"~     This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and~     efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with~     Cushing's disease.~   "
128396|NCT01374893|"~     Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to~     assess the effectiveness of an intrahospital strength and walk program during short hospital~     stays for improving functional capacity of patients aged 75 years or older.~      Methods Patients aged 75 years or older admitted for a short hospital stay (≤14 days) will~     be randomly assigned to either a usual care (control) group or an intervention (training)~     group. Participants allocated in the usual care group will receive normal hospital care and~     participants allocated in the intervention group will perform multiple sessions per day of~     lower limb strength training (standing from a seated position) and walking (10 min bouts)~     while hospitalized. The Primary outcome to be assessed pre and post of the hospital stay~     will be functional capacity, using the Short Physical Performance Battery (SPPB), and time~     to walk 10 meters. Besides length of hospitalization, the secondary outcomes that will also~     be assessed at hospital admission and discharge will be pulmonary ventilation (forced~     expiratory volume in one second, FEV1) and peripheral oxygen saturation. The secondary~     outcomes that will be assessed by telephone interview three months after discharge will be~     mortality, number of falls since discharge, and ability to cope with activities of daily~     living (ADLs, using the Katz ADL score and Barthel ADL index).~      Results Results will help to better understand the potential of regular physical activity~     during a short hospital stay for improving functional capacity in old patients.~      Conclusions The increase in life expectancy has resulted in a large segment of the~     population being over 75 years of age and an increase in hospitalization of this same age~     group. This calls attention to health care systems and public health policymakers to focus~     on promoting methods to improve functional capacity of this population.~   "
128397|NCT01374880|"~     The objective of this work is to investigate and then to sequence new biomarkers in the~     plasma of patients presenting with dyspnea secondary or not to heart failure, and study~     their diagnostic and prognostic value.~   "
128398|NCT01374867|"~     The aim of CardShock Study is to recognise significant prognostic factors in order to detect~     patients with increased mortality risk to which one could possibly direct more intensive~     treatments.~      The study will provide clinical, functional and invasive haemodynamic measures with~     systematic serial sampling and evaluation. In addition, the knowledge on the pathophysiology~     of cardiogenic shock is increased.~   "
128399|NCT01374854|"~     Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration~     therapy with mild side effect as indicated by large quantities of animal experiments and~     some clinical trials. There are few UC-MSCs clinical trials with regard to diabetes~     mellitus. The investigators hypothesize that infusion of USC-MSCs may provide multiple~     signals for beta-cell regeneration and even re-differentiate into local tissues in diabetes~     mellitus patients, resulting in improvement of diabetic control, of which the effect may be~     promoted by concomitant infusion of bone marrow mononuclear cells and maximized by~     intra-arterial pancreatic infusion through angiography.~   "
128400|NCT01374841|"~     The purpose of this study is to determine if engraftment can be achieved safely in patients~     with high-risk hematologic malignancies who undergo non-myeloablative transplant with~     peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and~     post-transplant cyclophosphamide as immunosuppression.~   "
128441|NCT01374295|"~     In order to compare two different forms of patient education; patients who receive Lortab~     medication or prescription during their ED visit are randomized to receive either standard~     patient education (from healthcare provider) or video assisted education. After education,~     patient completes a survey, estimated to take 5 minutes to complete.~   "
128402|NCT01374815|"~     In this study, the investigators will be using The Online Advocate, a Web-based~     health-related social problems screening and referral tool, to explore the relationship~     between health-related social problems and children's diet quality among families with young~     children attending the Children's Hospital Primary Care Center. The Online Advocate consists~     of a 60-80 question screening survey for health-related social problems (such as food~     insecurity, employment and income, homelessness) and allows participants to select referrals~     for local health and social service agencies that might help them with the problems~     identified through the survey. Layered into The Online Advocate for this study is an~     adaptation of the Harvard Service Food Frequency Questionnaire (HSFFQ) that can assess~     children's diet quality. The investigators plan to recruit 350 parent/guardians of otherwise~     healthy children age 3-10 years who are presenting to the primary care center for routine~     well child care. Eligible parent/guardians will have the opportunity to take The Online~     Advocate (plus HSFFQ) on a laptop computer in the waiting area before seeing their~     pediatrician or healthcare provider. Participants will receive a small incentive for their~     time as well as written information on healthy nutrition and an age appropriate coloring~     book for the child. At one month, participants will be contacted by the study team by email~     or phone and asked follow up questions about the status of their health-related social~     problems identified through The Online Advocate and whether the referrals they received were~     helpful. Participants will receive a small incentive for their time, along with a reminder~     message promoting healthy nutrition for their child. At three months, participants will be~     contacted by the study team by email or phone and asked follow up questions about the status~     of their health-related social problems identified through The Online Advocate and whether~     the referrals they received were helpful. They will also re-take the adapted HSFFQ.~     Participants will receive another small incentive for their time. Participants will also~     have the opportunity to re-take The Online Advocate at three months, though this is~     optional. The investigators believe this pilot study will provide foundational knowledge~     about the intersection between health-related social problems and children's diet quality~     and may inform future research studies and interventions.~      Our Study Aims are:~        1. To use The Online Advocate to evaluate the association between health-related social~          problems and diet quality in children in a cross-sectional sample.~        2. To evaluate the relationship between resolution of health-related social problems using~          The Online Advocate and change in diet quality in children over a 3 month period.~      Our Study Hypotheses are:~        1. A greater number of health-related social problems per family will be associated with~          poorer diet quality in children at baseline.~        2. After 3 months, families demonstrating resolution of one or more health-related social~          problems addressed with The Online Advocate will demonstrate greater improvement in~          diet quality in children.~   "
128403|NCT01374802|"~     The objective of the current study is to investigate the effect of multiple oral daily doses~     of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with~     ritonavir.~   "
128404|NCT01374789|"~     The primary objective of the study is to assess the efficacy of the combination consisting~     of gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type~     HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared~     to expectations derived from historical data, which are verified by a randomised control~     group without the antibody.~   "
128405|NCT01374776|"~     Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/~     kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic~     premenopausal women with iron deficiency on~      Primary objective:~      - Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of~     the lower leg muscle)~      Secondary objectives:~        -  Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at~          submaximal power during a constant-load cycling exercise test~        -  Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry~        -  Trial with medicinal product~   "
128406|NCT01374763|"~     The aim of the study is to describe the effects of oxycodone/naloxone combination in~     comparison to oxycodone for the treatment of postoperative pain in patients undergoing~     cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and~     the need of laxatives will decrease.~   "
128407|NCT01374750|"~     The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based~     immunosuppressive regimen in patients following living donor liver transplantation for~     hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival.~   "
128408|NCT01374737|"~     There are several recommended doses of dexmedetomidine for prevention of emergence agitation~     in children. In this study, the investigators examine ED50 in prevention of emergence~     agitation after tonsillectomy or adenoidectomy in children.~   "
128409|NCT01374724|"~     The prevalence of tobacco use in the military is too high. This study is designed to take~     advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and~     develop effective interventions to prevent tobacco relapse.~      Hypotheses or Research Questions:~        -  Are there differences in the rate of relapse between three groups participating in a~          tobacco abstinence maintenance intervention?~        -  Do the tobacco abstinence maintenance interventions delay relapse?~   "
128410|NCT01374711|"~     The human body knows a biphasic immunological reaction to sepsis. First, the~     pro-inflammatory reaction takes place, marked by the release of pro-inflammatory cytokines~     like TNF-α, as a reaction to the bacterial toxins. Secondly, the counter regulatory~     anti-inflammatory reaction arises. This phase is acting as negative feedback on the~     inflammation by inhibition of the pro-inflammatory cytokines. This is called~     immunoparalysis, a pronounced immunosuppressive state, which renders patients vulnerable~     to opportunistic infections. Most of the septic patients survive the initial~     pro-inflammatory phase, but die during this second stage.Research in the past has shown that~     immunostimulatory therapy with GM-CSF or IFN-γ has promising effects on the pro-inflammatory~     reaction during immunoparalysis ex vivo. Both drugs are known for their immunostimulatory~     effects. Recent pilot studies have showed in septic patients, that long-lasting monocyte~     deactivation in sepsis ex vivo can be reversed by these two immunostimulants. However, the~     mechanism and extent of immunoparalysis recovery may be different between the two compounds.~     Previously it has been shown that human endotoxemia (induced by LPS), leads to marked~     immunosuppression in healthy individuals, characterized by a transient refractory state to a~     subsequent LPS challenge (endotoxin tolerance). Consequently, human endotoxemia can serve as~     a standardized, controlled model for sepsis-induced immunoparalysis. Until now, all studies~     have focused on the ex vivo tolerance. However, we have recently proved, that the ex vivo~     condition is not completely representative for the in vivo situation. Ex vivo, leukocyte~     tolerance to LPS resolves within one day, while the in vivo immunoparalysis persists for two~     weeks. In this project, we will investigate the effects of both GM-CSF and IFN-γ in a~     parallel double-blind placebo controlled randomized manner on the immunoparalysis following~     human endotoxemia, both in-vitro and in vivo. As a result, we hope to get more insight in~     the pathophysiology of sepsis-induced immunoparalysis and thereby develop new~     immunostimulatory therapies that improve patient outcome~   "
128411|NCT01374698|"~     This is a prospective, randomized study conducted in patients undergoing coronary~     revascularization procedures (PCI) through angioplasty. All patients who meet the~     eligibility criteria will be randomized to receive, before the procedure, an oral aspirin~     reload (325 mg) and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and~     30 day, 3 and 6 months.~   "
128424|NCT01374516|"~     The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in~     preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of~     Latin America.~      Primary Objective:~      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in~     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due~     to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of~     inclusion.~      Secondary Objectives:~      To describe the occurrence of serious adverse events (SAEs), including SAEs of special~     interest in all subjects throughout the trial period.~      To describe the efficacy of CYD dengue vaccine after each dose in:~        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four~          serotypes~        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based~          on serological criteria, due to any of the four serotypes~   "
128412|NCT01374685|"~     Background:~      - Certain genetic mutations are linked to higher rates of cancer. It is important for people~     with these mutations to tell their families about it. This is because others in the family~     may also be at greater risk for developing these cancers. They can also pass these genes to~     their own children. But not much is known about how African Americans tell their family~     members about the results of their genetic testing. The information from this study can be~     used to improve genetic counseling services. These services will then be more effective in~     early cancer detection and prevention in the African American community.~      Objectives:~      - To learn more about how African Americans who have tested positive for BRCA1/2 mutations~     tell their families about their genetic risk.~      Eligibility:~      - African American (or of African descent) women who recently received positive test results~     for BRCA1/2 mutations.~      Design:~        -  Participants will be screened with a basic medical history.~        -  They will be asked general questions about their personal and family history. These~          include questions on marital and health insurance status, education, and income.~        -  Those in the study will have a 45- to 60-minute phone interview. They will answer~          questions about how they told their family members about their genetic test results.~          They will also be asked what that experience was like.~   "
128413|NCT01374672|"~     This research study is studying biomarkers in predicting response to chemotherapy in samples~     from young patients with osteosarcoma. Studying samples of tumor tissue from patients with~     cancer in the laboratory may help doctors learn more about changes that occur in DNA and~     identify biomarkers related to cancer. It may also help doctors predict how patients will~     respond to treatment.~   "
128414|NCT01374659|"~     Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to~     locate recurrent differentiated thyroid carcinoma lesions in patients with elevated~     thyroglobulin levels but who do not show pathological lesions when conventional imaging~     modalities are used. Thus, the investigators evaluated the effectiveness of PET/CT using~     both [124I] and [18F]-FDG in such patients.~   "
128415|NCT01374646|"~     This study will evaluate the effectiveness of a comprehensive community based program on~     reducing excess weight in children and teens. This study will recruit 150 participants~     between the ages of 6-12 and 13-17.~   "
128416|NCT01374633|"~     Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure~     (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped~     with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12~     hours. Sedation will be controlled with BIS.~   "
128417|NCT01374620|"~     The aim of the study is to determine the MTD of Paclitaxel in association with metronomic~     Cyclophosphamide.~   "
128418|NCT01374607|"~     It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected~     acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of~     myocardial infarction. New methods have been developed to improve the accuracy of the assay~     and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS~     assay is supposed to help early detection of myocardial infarction after onset of symptoms.~     It should therefore shorten the transit time to emergencies by a more rapid intervention or~     a faster return home. The aim of the study is to compare TnT-HS assay to the standard~     troponin assay in the detection of early cardiac ischemia in patients with ACS.~   "
128419|NCT01374594|"~     PURPOSE~      The goal of the present project is to unravel the importance of bile acid-induced GLP-1~     secretion (via the G protein-coupled receptor TGR5) in human physiology.~      In the present study the investigators examine the GLP-1 secretion in healthy subjects and~     in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients~     with T2DM of relatively long duration will be characterized by reduced gall bladder~     emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated~     postprandial GLP-1 responses (primary endpoint).~   "
128420|NCT01374581|"~     This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to~     investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for~     example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in~     RDCongo, on malaria incidence and its potential selection of resistant strains.~      Patients will be followed-up for efficacy and safety during 42 days after treatment with the~     first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda~     and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT~     or an other ACT or oral Quinine + clyndamicin.~      The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14~     days is as efficacious as any other rescue treatment, without the risk of selecting drug~     resistant strains.~   "
128421|NCT01374568|"~     The purpose of this study is to determine if the use of sitagliptin increases bone formation~     and reduces bone turnover in postmenopausal women with type 2 diabetes.~   "
128422|NCT01374555|"~     The study is designed to evaluate the predictive accuracy of the CardioSond digital~     electronic stethoscope in the detection of coronary artery disease (CAD) in patients with~     and without known disease who are referred to cardiac computed tomography angiography (CT~     scans).~   "
128423|NCT01374542|"~     Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy.~     The diagnostic yield, technical factors and complications for all patient sub-populations is~     still not clearly defined. This may result in inappropriate or even dangerous application of~     such procedures. The aim of the study is to collect data on these aspects of respiratory~     endoscopy and identify important trends, as well as, areas for improvement. This data will~     also provide baseline comparative data for new bronchoscopic techniques such as~     endobronchial ultrasound and navigational bronchoscopy.~      Method: Prospective data collection. Technical details regarding these procedures are~     currently keyed into the OTM system by the endoscopy operators for documentation and~     billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of~     all the fields from the OTM system for audit purposes.(See data collection form) The~     research project proposes to make the data non identifiable by removing the patient's name~     and IC number. Additionally the yield of the procedure will be checked by a chart review of~     the histology and microbiology results. There are no restrictions on patient recruitment~     because all procedures will be performed for clinical indications only and no patient will~     be recruited for the sole purpose of the study. Waiver of consent has been approved by the~     IRB.~   "
128428|NCT01374464|"~     Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics~     (morphine) to control pain. Morphine has numerous unwanted side effects including sedation,~     hallucinations and vomiting.~      It is now standard procedure for patients undergoing shoulder surgery to have their pain~     controlled by means of an injection made around the nerves where they pass through the neck~     to supply the shoulder with sensation (similar to the numbing injections made by the dentist~     before a dental procedure). This injection is called a 'nerve block'.~      Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to~     discharge patients home on the day of surgery, pain free and with no opiate side effects.~     However, a side effect of nerve blocks at this level is involvement of the phrenic nerve,~     which is anatomically close to the injection point. This may cause (temporary) paralysis of~     the diaphragm and in some cases, severe respiratory dysfunction.~      Research shows that reducing either the volume or the concentration of the drug injected,~     can reduce the consequent respiratory dysfunction. However no study has compared both volume~     and concentration in parallel, to see which of these has the more significant effect in~     reducing respiratory dysfunction. Furthermore there has been no assessment of how these~     changes may affect the duration of analgesia received and patient coping after discharge.~      The investigators propose to conduct a double blind randomised controlled trial at the Royal~     Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic~     (key hole) surgery over a period of 6 months. Patients will receive one of four treatment~     allocations:~        1. Low concentration-high volume of local anaesthetic~        2. Low concentration-low volume of local anaesthetic~        3. High concentration-high volume of local anaesthetic~        4. High concentration-low volume of anaesthetic drug of local anaesthetic.~      The aim of this study is to inform an optimum dosing regimen for patients in order to~     facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.~   "
128429|NCT01374451|"~     This study will estimate the treatment effect of everolimus in combination with pasireotide~     LAR relative to everolimus alone on progression-free survival (PFS) in patients with~     advanced progressive PNET.~      A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not~     meet its primary objective, which was based on progression-free survival (PFS) as per local~     radiology assessment and was prematurely terminated with the last patient last visit on~     19-Feb-2015. However, it is important to note that the data did not reveal any new safety~     concerns. It was decided to stop the study and this decision was shared with the study sites~     on 31-Jul-2014.~   "
128430|NCT01374438|"~     This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to~     the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in~     older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this~     population will also be studied. These results will be used to design larger studies of~     MSDC-0160 in persons with mild Alzheimer's disease.~   "
128431|NCT01374425|"~     This will be a randomized, open-label, multicenter, Phase II study with primary objectives~     to assess whether expression of select chemotherapy markers is associated with~     progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin,~     5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil,~     and irinotecan (FOLFIRI). The study population will consist of participants with first-line~     mCRC.~   "
128432|NCT01374412|"~     Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and~     localized microcirculation in test animals with osteoporosis, fractures and after placement~     of bone substitute material with volume computed tomography (VCT) (animals only) and~     functional magnetic resonance imaging (MRI). Furthermore patients with multiple myeloma (MM)~     will be examined before and after placement of a commercially available bone substitute~     material. Osseous structures before intervention and structural changes of the bone~     especially at the junction of substitute material and residual bone will be documented. At~     this, the proposed techniques allow imaging of the dynamic healing processes in the living~     organism.~      As next step patients with asymptomatic MM will be investigated with functional Imaging~     longitudinally to predict the occurence of osteolyses at time of Progression.~      Hypothesis: Affection of microcirculation at the junction of bone and bone substitute~     material can be displayed by VCT and functional MRI~   "
128433|NCT01374399|"~     The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an~     one-year physical exercise intervention on prognosis, side-effects and complications after~     allogeneic stem cell transplantation.~      The exercise intervention includes both, resistance and endurance training. Patients~     assigned to the control group perform a relaxation program (progressive muscle relaxation -~     Jacobsen) and have the same frequency of social contact.~   "
128434|NCT01374386|"~     The purpose of this study is to gather information on how much exercising with video games~     (ExerGaming) can increase the physical activity among overweight and youth. This study will~     try to see if participating in physical activity and exercising with video games at the same~     time can make overweight children move around more to better their own health. The~     hypothesis is that those in Exergaming arm will physiological changes and increase physical~     activity.~   "
128435|NCT01374373|"~     The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® )~     administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia~     (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.~   "
128436|NCT01374360|"~     This study is a collection of data to evaluate safety and characterize progression of~     Paroxysmal Nocturnal Hemoglobinuria (PNH).~   "
128437|NCT01374347|"~     The study will be an open label one and will include 30 patients who underwent ischemic~     stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain~     SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a~     second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk~     factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT~     study will be performed 24 hours after the last dose.~   "
128438|NCT01374334|"~     Aging is associated with loss of muscle strength and a serious import of physical~     disability. Treatment of age-related physical disability should focus on the prevention of~     the condition rather than the consequences. Need to modify daily tasks is an early sign of~     future mobility disability. Many older adults who utilize daily task modifications report no~     mobility difficulty. Neglect to self-report task modification may delay intervention.~     Identifying objective marker of task modification will help to identify task modifiers.~   "
128439|NCT01374321|"~     Objectives of the phase 2 prospective, multicenter, randomized, double-blind,~     placebo-controlled study is to assess safety and efficacy of TRO40303 administered just~     before balloon inflation during percutaneous coronary intervention (PCI) for limitation of~     infarct size in patients treated for acute myocardial infarction (AMI).~      The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred~     eighty patients will be included. It will last one month per patient and its overall~     duration will be 11 months.~      The efficacy will be assessed by infarct size expressed as area under the curve for creatine~     kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac~     Magnetic Resonance.~      Safety will be assessed by~        -  clinic evaluation,~        -  blood samples (hematology, biochemistry, renal and hepatic function),~        -  Recording and follow-up of major adverse events occurring during the first 48h after~          reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat~          revascularization, renal or hepatic, vascular complication and bleeding).~        -  ECG~        -  Recording cardiac events during one month after AMI~        -  Follow-up of global left ventricular function by Echocardiography at D3 and D30.~      Demographic and medical history at inclusion and non-cardiac events occurring during the~     first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min,~     6h, and 12h post the end of administration.~      Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a~     statistical power of 85% and a probability of type I error of 0.05.~      Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be~     performed using O'Brien's method for multiple endpoints testing.~      Secondary analysis: comparisons of the CMR criteria described above will be performed using~     mixed model of ANCOVA.~      All analyses will be performed on the Full Analysis Set and Per protocol populations.~      Safety analysis: A comparison of the incidence of cumulative adverse clinical events between~     the groups will be performed by Fisher's exact tests.~      Subjects will undergo primary PCI and receive concomitant medications according to current~     standard of care.~      After coronary angiography is performed but just before balloon inflation is performed,~     patients who meet the enrollment criteria will be randomly assigned to either the control~     group or the TRO40303 group. Randomization is ensured by taking the treatment units in~     ascending and consecutive order in each strata (anterior/posterior as determined on ECG).~     Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes~     before balloon inflation and stenting, the patients in the TRO40303 group will receive an~     intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral~     IV. The patients in the control group will receive an equivalent volume of the placebo.~     Patients will be hospitalized for as long as there is a medical indication. CMR and~     echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and~     5. A follow-up visit will be conducted one month after PCI.~   "
128440|NCT01374308|"~     The general objective of the present clinical trial is to compare the therapeutic efficacy~     of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and~     hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug,~     pegylated interferon in patients with chronic hepatitis B (CHB).~   "
129318|NCT01362751|"~     In this study the investigators aimed~        1. to investigate the prevalence of orthostatic hypotension in elderly nursing home~          residents.~        2. to investigate whether the presence of orthostatic hypotension influences the chance of~          successful rehabilitation.~   "
128443|NCT01374269|"~     Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and~     improving function and quality of life during a 6-months follow-up of a therapeutic exercise~     program compared to pharmacological treatment with NSAIDs in patients with subacute low back~     pain attending the physiatrist consultation of several ambulatory health centers in Medellín~     during the years 2009-2010.~   "
128444|NCT01374256|"~     Infections caused by imipenem-resistant Acinetobacter baumannii are associated with high~     mortality and morbidity. The treatment choices for this resistant pathogen are limited.~      The objective of the present proposal is to evaluate the effectiveness of combination~     therapy of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate~     the clinical effect with the in vitro synergistic results.~   "
128445|NCT01374230|"~     This study has been designed to document the long-term outcome of the E1® Tibial Bearings~     used with the Vanguard® Knee System in 50 patients receiving total knee arthroplasty. All~     patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic~     analysis and patient reported outcomes will be used as follow-up measures to track wear,~     mechanical performance, and patient satisfaction.~   "
128446|NCT01374217|"~     The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in~     combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.~   "
128447|NCT01374204|"~     Few data about epilepsy-associated stigma in France are available. The only study we have~     found showed that in France 66% of people with epilepsy felt stigmatized by their condition~     and are often single, compared with the other European patients interviewed (Baker et al.,~     2000). The purpose of this study is to assess the association between type of epilepsy (drug~     resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in~     patients recruited in the Limousin region .~   "
128448|NCT01374191|"~     The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective~     treatment for painful neuromas. The ideal therapy for painful neuromas would be effective,~     non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy~     would also address the complex peripheral and central mechanisms. Btx-A is a potential~     treatment that addresses each of these requirements while preserving the existing sensation~     and function.~      Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo~   "
128449|NCT01374178|"~     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of~     LY2963016 compared to those of basal insulin. The study will also gather information on the~     safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12~     weeks.~   "
128450|NCT01374165|"~     Prolong proposes to test safety, tolerability and pharmacokinetics of SANGUINATE™ in sickle~     cell disease (SCD) patients. Prolong's preclinical studies showed that SANGUINATE™ was safe~     in a number of different animal models and toxicology studies. In this Phase I trial,~     Prolong will test whether it is also safe and tolerable in sickle cell patients. The study~     will be conducted in 15 adult (>18 years) patients.~   "
128451|NCT01374152|"~     The cognitive sensory motor training therapy (Perfetti's technique) might be more~     effectiveness than conventional occupational therapy on upper extremity function recovery~     after acute stroke patients.~   "
128452|NCT01374139|"~     The purpose of this study is to demonstrate the bioequivalence of the clinical tablet~     formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy~     subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on~     the pharmacokinetics of bosutinib after administration of the proposed commercial tablet~     formulation (100 mg x 4) in healthy subjects (Cohort 2).~   "
128453|NCT01374126|"~     A randomized controlled trial to assess the safety and efficacy of azithromycin combination~     therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated~     malaria patients in southeastern Bangladesh.~   "
128454|NCT01374113|"~     The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the~     compound in the body) of safinamide in subjects with different degrees of renal impairment~     in comparison to matched subjects with normal renal function.~   "
128455|NCT01374100|"~     Cancer patients face a number of symptoms related to treatment or disease which may impair~     quality of life, such as decreased functional capacity, fatigue, nausea an vomiting,~     distress, depression and unmet psychological needs. Due to this array of symptoms, cancer~     patients often seek supportive complementary and alternative medicine, which many patients~     use along with conventional treatments. Qigong, a type traditional chinese medicine, is a~     mind-body exercise that combines meditation, slow physical movements, and controlled~     breathing. The investigators hypothesise that Qigong therapy is better in the reduction of~     anxiety and depression levels and the improvement of quality of life in patients with lung~     and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared~     to standard exercise training.~   "
128456|NCT01374087|"~     The purpose of the protocol, is to compare the efficacy of brachytherapy versus~     brachytherapy plus triptorelin 22.5 mg (single injection) in patients with recurrence of~     prostate cancer previously treated with radiotherapy.~   "
128457|NCT01374074|"~     The goal of the proposed research is to investigate the molecular mechanisms of racial~     disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma.~     Specifically, the investigators hypothesize that environmental factors, genetic factors, and~     potentially gene environment interactions play crucial roles in the observed racial~     disparity in developing Barrett's esophagus.~      Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy~     (EGD). Participants complete a questionnaire, have body measurements obtained, and have~     blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH~     impedance test.~   "
128458|NCT01374061|"~     The objective of this work is to compare standard intubation with video laryngoscope (Glide~     scope Ranger ) in French pre hospital multicentric study.~   "
128459|NCT01374048|"~     Patients are subjected to simultaneous intracranial and lumbar puncture pressure~     measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial~     pressure amplitude is reflected by lumbar puncture pressure amplitude.~   "
128489|NCT01373645|"~     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and~     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel~     from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd)~     may prevent these complications.~   "
128460|NCT01374035|"~     The main object to this trial is to study the function of referral letters as a mean to~     coordinate the care process for adult people when referred from Primary Care to Specialised~     Mental Health Care. The study will explore if and to what degree the quality of these~     referral letters can be improved, and the potential improvement's impact on defined~     patient-, professional and organisational related outcomes. According to Medical Research~     Council guidelines for evaluating complex interventions, a stepwise design with the use of~     both qualitative and quantitative methods will be used to conduct a controlled intervention~     study.~   "
128461|NCT01374022|"~     Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit.~     Discussions about it is exponentially growing up due its high mortality rates all over the~     world and low quality of life among survivors. Mechanical ventilation is recognized to play~     an important role in treatment of patients with ARDS. However, mechanical ventilation itself~     has the potential to produce or worsen alveolar injury if inadequate strategies are chosen.~     Several studies compared different mechanical ventilation strategies in ARDS but the results~     remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is~     a multicentric randomized controlled trial, with allocation concealment and intention to~     treat analysis to investigate if maximum alveolar recruitment maneuver in association to~     Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system~     (ART strategy) is able to increase 28 days survival in patients with ARDS compared to~     conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients~     considered to this trial are those in mechanical ventilation with diagnosis of ARDS less~     than 72hours. Patients will be excluded if they are less than 18 years old, in use of~     vasopressors drugs in increasing doses over the last 2 hours or mean arterial blood pressure~     less than 65mmHg, presence of any contraindication to hypercapnia, undrained pneumothorax or~     subcutaneous emphysema and lack of consent from patient's surrogate to participation.~     Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be~     followed until hospital discharge, 28 days and 6 months.~   "
128462|NCT01374009|"~     The goal of this study it to rapidly create a brief registry of pregnant women who receive~     the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1~     2009/2010 influenza season.~   "
128463|NCT01373996|"~     The purpose of this study is to determine whether wireless transmission of invasive arterial~     blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor~     is feasible, safe and as accurate as conventional cable connection.~   "
128464|NCT01373983|"~     The purpose of this study is to evaluate if the effect of ziconotide can be tested by~     intrathecal bolus doses.~   "
128465|NCT01373970|"~     Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at~     withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion.~     Whether this also applies for patients with dyspeptic symptoms but without true reflux~     disease (functional dyspepsia) treated with PPI is unknown. If this is the case, it could~     lead to an unfortunate long term use of PPI, since the acid rebound renders withdrawal too~     difficult.~      This is a single centre, randomized, double-blinded, placebo-controlled cross over study.~     Study period is 12 weeks per study subject. Study subjects are referred to the study from~     General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the~     investigational centre.~      The study population consists of patients who seek their GP because of dyspepsia without~     alert signs, and whom the GP may consider starting on PPI. Out patients referred to the~     gastroenterology department or endoscopy clinic of the investigational centre because of~     dyspepsia without specific exclusion criteria are also invited to participate.~      Baseline interview, upper endoscopy and pH monitoring are performed one week before~     inclusion to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by~     Helicobacter Urease Test (HUT). Hp. positive subjects without ulcus are not excluded.~      Patients with a positive pH monitoring will not be included in the analysis regarding the~     primary endpoint (Development of GERD) but will be included in the analysis regarding one of~     the secondary endpoints (Effect of PPI on Functional Dyspepsia).~      Study subjects are randomized to either pantoprazol followed by cross over to placebo or to~     placebo. Escape medication in the form of Gaviscon can be used on demand.~      Internet based questionnaires are answered weekly. Questionnaires consist of the~     Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing~     postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux~     Disease (GERD).~      Compliance to protocol is assessed at hospital visits every fourth week. At the end of study~     endoscopy and pH monitoring are repeated.~   "
128466|NCT01373957|"~     EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which~     will include patients, in a real-life setting, who are hospitalized for acute coronary~     syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable~     Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial~     Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard~     medical care as determined by the treating cardiologist. Patients will not receive~     experimental intervention or experimental treatment as a consequence of their participation~     in the EPICOR-RUS observational study.~   "
128467|NCT01373944|"~     The purpose of this study is to compare clinical efficiency and patient outcomes using ultra~     low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.~   "
128468|NCT01373931|"~     This study involves a single dose of 18 mg LY2216684 taken as 1 or 2 tablets by mouth. The~     study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive~     Ortho Cyclen®. This study will run approximately 93 days.~   "
128469|NCT01373918|"~     Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral~     Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to~     prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of~     standard intravenous fat emulsions have implicated in the development and progression of~     PNAC.~      In this study, neonates with congenital/acquired gastrointestinal disorders will be~     randomized, in a unblinded fashion, to receive either the standard dose of an intravenous~     omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion~     throughout their course of PN or until hospital discharge, death or 100 days of life,~     whichever comes first. The primary outcome will be the presence of cholestasis.~   "
128470|NCT01373905|"~     Acute respiratory distress syndrome is a severe lung disease caused by a variety of direct~     and indirect issues. It is characterized by inflammation of the lung parenchyma leading to~     impaired gas exchange and persistent hypoxemia. This condition is often fatal, usually~     requiring mechanical ventilation. Recruitment maneuver aimed to enhance the effect of~     mechanical ventilation.The objective of this study was to compare safety and efficacy of two~     lung recruitment maneuvers.~   "
128471|NCT01373892|"~     Diet and nutrition are important factors in the maintenance of good health throughout the~     entire life course. Their role as determinants of chronic diseases such as obesity, diabetes~     and cardiovascular diseases is well established. The annual increase in the prevalence and~     the severity of obesity in both adults and children is currently substantial, and in Finland~     40% of adults are overweight or obese. Identifying the mechanisms that make some individuals~     vulnerable to overeating, as well as pinpointing how obesity changes the functioning of the~     human mental and bodily functions would be critical for understanding the current high~     prevalence of obesity.~      Animal studies suggest that the brain extensively coordinates the adaptive mechanisms and~     the alterations of energy intake and expenditure. Accumulating evidence suggest that obesity~     is associated with changes in brain morphology and function, thus the source for obesity may~     lie in the brain. In the present project the investigators test this hypothesis by~     implementing a multimodal neuroimaging approach with positron emission tomography (PET),~     functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI) and voxel-based~     morphometry (VBM). By studying brain anatomy and function in lean individuals as well as~     obese patients undergoing weight loss surgery, the investigators can evaluate whether the~     observed differences between lean and obese individuals are causes or consequences of~     obesity. In PET imaging of the brain, the investigators will focus on two specific~     neurotransmitter systems, dopamine and opioid, which are largely been unexplored in obesity~     research.~      Obesity is related to elevated plasma glucose levels and endothelial dysfunction. Elevated~     plasma glucose and endothelial dysfunction are known risk factors for diabetes and coronary~     heart disease.~      Weight reduction modifies risk factors such as blood pressure and lipid profile for chronic~     diseases. On this study the investigators are able to further investigate changes in fatty~     acid metabolism and hormones affecting feeding and energy balance. In addition, changes in~     brain activation in response to food stimuli will be assessed. As far as the investigators~     know there are no previous positron emission tomography (PET) studies that investigate these~     risk factor variables from one study population pre-operatively and after bariatric surgery.~      The objectives of this study are to measure effect of obesity on brain structure and~     molecular pathways, food-stimuli mediated brain activation response, on hormones affecting~     both feeding and energy balance as well as on bone metabolism and bone marrow fat. The study~     consists of two phases. In the first phase the studies are performed at baseline before~     bariatric surgery and in the second phase post-operatively after 6 months. Regional free~     fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas,~     liver, brain, intestine and the bone are studied with PET and 14(R,~     S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat distribution, in~     ectopic fat and fat content of key organs are investigated with magnetic resonance imaging~     (MRI) and magnetic resonance spectroscopy (MRS). ). Cardiac functioning is studied with~     echocardiography and functional MRI (fMRI) and ectopic fat in and around the heart using MRI~     and MRS. Brain reward system response to food stimuli is assessed using functional MRI~     (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI). Brain~     neurotransmitter system will be measured with [11C]raclopride and [11C]carfentanil and PET.~     In the second part of the study the same variables are studied after bariatric surgery:~     either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. The objective is also to~     study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and~     co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the changes in~     tissue metabolism between these two surgical procedures.~      The study consists totally of 60 study subjects. Of these 40 are morbidly obese adults, BMI~   "
128505|NCT01373437|"~     The purpose of this study is to assess the applicability of using ultrasonography in~     confirmation of the position of the endotracheal tube (ETT) after intubated to patients.~   "
128472|NCT01373879|"~     The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and~     AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria~     endemic region. The regimen proposed here has protected non-immune volunteers in Oxford~     against sporozoite challenge, and so may be protective against naturally acquired infection~     in The Gambia.~   "
128473|NCT01373866|"~     -  The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from~          drug-resistant multisensory hallucinations will be tested by the implementation of a~          double-blind randomized controlled trial (RCT)~        -  This study will use a combination of different MRI modalities (fMRI and DTI) to define~          with precision rTMS brain-targets in the case of multisensory hallucinations~        -  The investigators anticipate that multimodal MRI-guided rTMS will allow a significant~          improvement in the efficacy of neuromodulation treatment of refractory hallucinations~   "
128474|NCT01373853|"~     This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye~     study to determine the safety and efficacy of intraocular cuts for femtosecond laser~     assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to~     IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with~     the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and~     height dependent on anterior chamber depth, pupil diameter and ocular lens size.~      The hypothesis of the study is that by means of femtosecond laser assisted lens~     fragmentation the required ultrasound energy used for phacoemulsification can be reduced in~     a safe and effective way.~   "
128475|NCT01373840|"~     Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained~     muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in~     the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather~     rudimentary. A better understanding of neural mechanisms of dystonias is not only an~     invaluable prerequisite for developing better treatment options but also a step toward~     better understanding of the complex network of basal ganglia. In this study I will~     investigate if there is any difference between the dopamine receptors and dopamine in people~     with dystonia and healthy subjects.~   "
128476|NCT01373827|"~     Patients enrolled in this study will come from the Investigator's patient population and be~     ordinarily suitable for treatment using the MC1 device. The treatment they receive will be~     no different if they participate than if they do not. The study is only to observe the~     patients before, during and after their usual treatment.~   "
128477|NCT01373814|"~     The goal of this study is to determine if nutritional therapy can effectively treat/prevent~     T2DM and its consequent cardiomyopathy.~   "
128478|NCT01373801|"~     The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR~     compared to standard bandaging in subjects with post partum hemorrhage as a result of~     cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30~     minutes after insertion of the dressing.~   "
128479|NCT01373775|"~     To identify the risk factors of the revisit of the adult HF patients in emergency~     department.~   "
128480|NCT01373762|"~     The purpose of this study is to determine whether an interactive exercise videogame bike is~     effective in improving physical activity adherence, motivations to do physical activity, and~     physical fitness among families. Families receive either an interactive videogame bike and~     gaming console, or a traditional stationary bike which is placed in front of the television,~     to keep in their home for six months. It is expected that families within the videogame bike~     condition will show greater exercise adherence. It is also expected that these families will~     have higher self-reported physical activity levels, greater motivation to do physical~     activity, and improved cardiovascular fitness at the end of the three month period compared~     to the families in the stationary bike condition.~   "
128481|NCT01373749|"~     Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent~     Pulmonary Hypertension (PPHN), while the safety of NO long term application was under~     investigation. Several research suggested too much NO2 was generated in the lung after long~     term (> 72h) use of NO inhalation, which cause bad effects on PS production.~      Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical~     effect but need monitoring of blood pressure. The possible hypotension effect restrict the~     dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend~     sildenafil to The purpose of the study was to establish if NO continued with sildenafil has~     the same effect as single NO inhalation.~   "
128482|NCT01373736|"~     The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic~     imaging agent in evaluating patients with known or suspected neuroendocrine tumors.~   "
128483|NCT01373723|"~     The aim of this study was to compare the effectiveness and the costs of three types of~     population interventions to increase the number of female participants in the screening~     programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care~     Areas.~   "
128484|NCT01373710|"~     The purpose of this study is:~      Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated~     by intrathecal or intraventricular route to reach a intra CSF target concentration (30~     µg/mL) near the conventional therapeutic concentration and depending on the dose-limiting~     toxicity (DLT)~      Phase II: Determination of antitumor activity trastuzumab when administrated by IT or~     intra-ventricular in terms of neurological progression-free survival at 2 months~   "
128485|NCT01373697|"~     The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety~     treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or~     myofascial compared to Profenid 25mg/g gel.~   "
128486|NCT01373684|"~     This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative~     chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the~     degree of HBsAg decline.~   "
128487|NCT01373671|"~     The primary objective of this protocol is to collect the 2-dimensional (2D) screening and~     diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from~     patient mammography examinations acquired on various commercially available Full Field~     Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.~   "
130972|NCT01341106|"~     This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect~     on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients~     with chronic hepatitis B infection.~   "
128490|NCT01373632|"~     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating~     patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW~     Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical~     trials. Here the investigators design a prospective, multicenter, randomized clinical study~     in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD~     patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel~     SES.~   "
128491|NCT01373619|"~     Heart failure with normal ejection fraction is often under diagnosed and certainly under~     treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine,~     a pure heart-rate lowering agent without effects on blood pressure, is of potential~     therapeutic utility.~   "
128492|NCT01373606|"~     This is an open-label, multi-center study, investigating the efficacy and safety of~     terlipressin in Japanese patients with hepatorenal syndrome type 1.~   "
128493|NCT01373593|"~     In this controlled study the investigators will examine the analgesic and sensory effects of~     ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in~     persistent postherniorrhaphy pain patients.~   "
128494|NCT01373580|"~     This study will be a prospective, multicenter clinical trial in which a total of 400~     subjects will be enrolled. All subjects will be followed over a 36 month time frame with a~     maximum of 15 clinical sites participating. Qualified subjects will provide informed consent~     for entry into the study.~   "
128495|NCT01373567|"~     Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting~     approximately 2% of the world's population.This phase IV study is planned to monitor~     performance of Tinefcon in patients suffering from psoriasis under conditions of actual use~     and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients~     treated with Tinefcon. This study will add to literature on the risks and benefits of~     Tinefcon the novel oral TNF-alpha release inhibitor.~   "
128496|NCT01373554|"~     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)~     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1~     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited~     the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also~     some research reported that LXRg (a member of the nuclear hormone receptor)-mediated~     increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the~     expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg~     and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and~     LXRg-SREBP-1c pathway in liver.~   "
128497|NCT01373541|"~     The purpose of this study is to determine the effect of infant formula with high percentage~     of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general~     gastrointestinal tolerance in Chinese formula-fed term infants.~   "
128498|NCT01373528|"~     Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is treated primarily~     with sinus surgery and the long-term use of topical steroid therapy. Budesonide irrigation~     is a common method of topical steroid treatment for these patients. However, the effects of~     budesonide irrigation on the hypothalamic-pituitary-adrenal (HPA) axis in patients with CRS~     following sinus surgery, is as of yet not defined. The objective of this study is to~     determine if topical sinonasal budesonide steroid irrigation leads to acute recoverable~     and/or long-term suppression of the HPA axis. Participants in this prospective cohort study~     will have CRS and have recently undergone endoscopic sinus surgery. They will also have had~     planned use of budesonide irrigations as their postoperative medical treatment. The acute~     effects of this treatment on the HPA axis will be evaluated using serial serum cortisol~     measurements both the day before and the day of the first budesonide irrigation. The~     long-term effect of sinonasal budesonide irrigation will be evaluated using both a pre- and~     post-treatment adrenocorticotropic hormone (ACTH) stimulation test as well as repeated urine~     free cortisol levels over the length of the study. The results will determine the need for~     additional steroids when patients stop treatment or with a physiologic stressful event.~   "
128499|NCT01373515|"~     This is an open label phase 1 feasibility and safety dose escalation study. The main~     objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.~   "
128500|NCT01373502|"~     The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy~     of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic~     lesions in native coronary arteries.~   "
128501|NCT01373489|"~     The purpose of this study is to help low income patients achieve and maintain better~     self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and~     blood pressure monitoring system and nurse case management. Patients must be served at a~     Federally Qualified Health Center (FQHC) in coastal South Carolina.~   "
128502|NCT01373476|"~     Objectives of study: To preliminarily evaluate the efficacy and safety of Qideng Mingmu~     Capsule in the treatment of patients with diabetic retinopathy (deficiency of Qi-Yin~     syndrome, blood stasis syndrome), to discuss the appropriate dose and period of treatment.~   "
128503|NCT01373463|"~     This study is open to patients that have been diagnosed with non-squamous Stage III Non~     Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.~      The purpose of this study is to:~        -  Test a combination of two chemotherapeutic drugs along with radiation therapy, when~          given prior to surgery and see what effects (good or bad) it has on someone with this~          type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and~          tissues.~        -  Test the safety of different dose levels of radiation when given with each combination~          of chemotherapy;~        -  Determine what side effects are associated with combining radiation with these two~          chemotherapy combinations.~   "
128504|NCT01373450|"~     This was a four-period crossover study to assess the glycemic effects of a single dose of~     oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus~     (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4~     treatment periods, with a 7-day wash-out between each treatment period. The primary~     hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or~     better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly~     enhancing insulin secretion.~   "
128506|NCT01373424|"~     Dystonia is a disorder characterized by excessive involuntary contraction of muscles with~     repetitive and patterned movements. The isolated dystonias are the most common type of~     dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic~     torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias~     (like blepharospasm). The purpose of this study is to create resources to help learn more~     about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to~     develop and validate various dystonia rating scales.~   "
128507|NCT01373411|"~     Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and~     randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48~     hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which~     time they will receive telephone follow-up one and nine months following CABG and clinic~     visits three, six, and twelve months following CABG.~   "
128508|NCT01373398|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of~     intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer~     (NMIBC).~   "
128509|NCT01373385|"~     The purpose of this research is to provide a clearer understanding of quality and outcomes~     for three types of surgical procedures performed at Connecticut Children's for treatment of~     vesicoureteral reflux. In order to consistently gather data over time, the investigators~     propose to establish database for surgical intervention for vesicoureteral reflux.~      Specific Aim 1: To consistently collect performance and outcomes data for the surgical~     treatment of vesicoureteral reflux in order to increase internal understanding of these~     procedures.~      Specific Aim2: To consistently collect performance and outcomes data for the surgical~     treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for~     publication.~   "
128510|NCT01373372|"~     Chronic abdominal pain is the most common persistent pain condition in children and~     adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed~     types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort~     (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the~     bathroom.~      For some people it appears that stress can make FD worse. In adults, stress can cause the~     release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can~     cause abdominal pain by affecting how fast things move through a person's stomach and~     intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness~     of the inside lining of the stomach and intestines.~      Different people react differently when the body releases CRH. Some people have abdominal~     pain without feeling any stress or anxiety while other people who have a lot of stress or~     anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or~     abdominal pain when CRH is released into the body.~      In order to see how the bodies of children with functional dyspepsia and those without~     functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test~     is routinely done in endocrine patients. It is not routinely done for patients with~     functional dyspepsia or for patients who do not have functional dyspepsia.~      Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel®~     (brand name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug~     Administration (FDA) for use.~      The purpose of this research study is to see if there are differences in how the bodies of~     children with functional dyspepsia react to CRH versus children who don't have functional~     dyspepsia.~      Being in this study involves one clinic visit where an IV placed and a CRH stimulation test.~     In this test the child will be given an injection of CRH and then observed for one hour.~     During that hour the child will have five blood draws through the IV and will be asked~     questions about their anxiety and abdominal pain. This visit will take about 4 hours.~      The following things will happen:~        -  Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This~          means your child will have had nothing to eat or drink for 8 hours before coming to the~          clinic.~        -  If your child is a female ten years of age or older, or has started having periods, a~          urine pregnancy test will be done before receiving the CRH infusion.~        -  You and your child will each be asked to complete a survey that measures your child's~          anxiety.~        -  Your child will have a biofeedback session that will measure your child's stress. In a~          biofeedback session, sensors are placed on your child's fingers, wrists and forehead.~          These sensors are connected to a computer that monitors your child's heartbeat, skin~          temperature and electrical pulses on your child's skin.~        -  Your child will have an IV inserted into a vein in his/her arm. Your child may have a~          cream put on their arm to help with the pain of the IV insertion. The IV will be used~          to inject the CRH and draw blood. If the IV stops working and blood samples can no~          longer be drawn from it, your child may have another IV started or blood samples may be~          drawn by needle stick.~        -  Your child will then have 30 minutes to relax.~        -  Your child will then have CRH infused through the IV over one minute.~        -  Your child will have blood drawn through the IV five times; right before the CRH~          stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total~          amount of blood drawn for the study will be about 2 ½ tablespoons.~        -  Your child will be asked about their abdominal pain, nausea, bloating, stress and~          anxiety at three separate times during the 60 minutes.~        -  Your child's heart rate will be measured throughout the CRH stimulation test.~   "
128511|NCT01373359|"~     Sublingual misoprostol produces rapid peak concentration and is more effective than oral~     misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to~     test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage~     have 30 ml less average blood loss than women receiving oxytocin, the standard of care for~     prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial~     of .652 consenting, eligible pregnant women admitted to the labor room of the teaching~     hospital at J N Medical College, Belgaum, India. Women participating in the study were~     assigned by computer generated randomization to receive the study medications and placebos~     within one minute after clamping and cutting the umbilical cord. We also looked at the drugs~     effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the~     percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side~     effects.~   "
128512|NCT01373346|"~     We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into~     gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb~     Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric~     cancer.~   "
128513|NCT01373333|"~     Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton~     Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with~     LEMS and hopefully will decrease the need for prednisone and all other therapies that were~     previously required to control symptoms. How long a patient will take 3,4 DAP depends upon~     if he/she is seeing benefits from the medication or experiencing side effects that will~     prevent them from continuation in the study.~   "
128514|NCT01373320|"~     The study purpose is to evaluate the effectiveness of a set of culturally appropriate,~     faith-placed lay health advisor interventions aimed at facilitating smoking cessation and~     increasing cancer screening among Appalachian participants.~   "
128515|NCT01373307|"~     The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed~     lay health advisor intervention aimed at increasing fruit and vegetable intake and physical~     activity among intergenerational Appalachian individuals and families.~   "
128516|NCT01373294|"~     The purposes of this study are to:~        -  find out whether participants' cancer returns or gets worse while they are taking~          lenalidomide and Bacille Calmette-Guerrin (BCG);~        -  evaluate the safety and tolerability of the combination of lenalidomide and BCG;~        -  compare the cancer progression of participants taking lenalidomide and BCG versus~          participants taking only BCG~   "
128517|NCT01373281|"~     The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing~     symptomatic, virologically-confirmed dengue cases.~      Primary Objective:~      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in~     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due~     to any of the four serotypes in children aged 2 to 14 years at the time of inclusion.~      Secondary Objectives:~      To describe the efficacy of CYD dengue vaccine after each dose in:~        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four~          serotypes~        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based~          on serological criteria, due to any of the four serotypes~      To describe the occurrence of serious adverse events (SAEs), including serious adverse~     events of special interest in all subjects throughout the trial period.~   "
128518|NCT01373255|"~     Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted~     into the uterine myometrium. The most significant complication is intense bleeding, mainly~     during labor. The most important risk factors are previous cesarean delivery, placenta~     previa, and advanced maternal age. Cesarean hysterectomy is the recommended management.~     During the recent years, inserting intravascular balloon catheter for occlusion and/or~     arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss~     during cesarean hysterectomy or in conduct with conservative management with the intent of~     avoiding hysterectomy in selective cases. Contradicting reports exist regarding the~     effectiveness and safety of the catheters in cases of placenta accreta. The objective of~     this study is to estimate the efficacy of the balloon catheters among women diagnosed with a~     placenta accreta.~   "
128519|NCT01373242|"~     The goal of this study will be to increase the reaction threshold (desensitization) of~     peanut allergic children using peanut sublingual immunotherapy and to determine if the~     nonreactive state of the immune system persists after treatment has been discontinued~     (tolerance).~   "
128520|NCT01373229|"~     In research studies, lenalidomide (also called Revlimid) has shown some response in chronic~     lymphocytic leukemia (CLL); however, responses are usually partial responses that occur~     after several months of taking the study drug. It is thought that by adding the drug~     plerixafor (also called Mozobil) responses may be improved and/or occur sooner.~      The main purpose of this study is to determine the dose of plerixafor that is safe to use in~     combination with lenalidomide. The study will also look at the response rates of the~     combination of lenalidomide and plerixafor and the effect the study drugs have on CLL cells.~   "
128521|NCT01373216|"~     GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects~     on cardiac function and metabolism in both experimental models and in patients with type 2~     diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and~     glucose control in patients undergoing cardiac surgery are not known. Based on the results~     of experimental studies there is a potential for exenatide to positively influence both~     cardiac function and glucose metabolism in cardiac surgery patients with and without type 2~     diabetes mellitus. The primary endpoint of this study is to examine whether pre- and~     peri-operative administration of exenatide affects perioperative hemodynamics,~     echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and~     glucose control in patients with coronary atherosclerosis and decreased left ventricular~     function undergoing elective coronary artery bypass grafting operation (CABG). In addition,~     safety and tolerability of peri-operative administration of exenatide in these patients will~     be examined as a secondary study objective.~   "
128522|NCT01373203|"~     The important character of acute lung injury (ALI) is alveolar capillary membrane damage~     caused by different diseases, such as sepsis, trauma and shock. One of the important~     pathological stages is the varying degrees of interstitial fibrosis and semi-permeable~     alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived~     factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated~     that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by~     ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was~     significantly increased in asthmatic patients with pulmonary fibrosis, which companies with~     increased CTGF expression. Therefore, this project assumes that fibrocyte will~     differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn~     leads to progression of fibrosis. The central hypothesis of this project is that peripheral~     progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury.~     The overall objective of this project is to study the role of fibrocytes in acute lung~     injury.~   "
128523|NCT01373190|"~     The specific aim is to determine if there are patterns of temperature differences in the~     abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a~     non-epileptic control group. The hypothesis is that individuals with partial/focal onset~     epilepsy will have colder recorded temperatures in the abdominal area than individuals in a~     matched control group.~   "
128524|NCT01373177|"~     The objective of this randomized study is to test the hypothesis that scores on the Bayley~     Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of~     Infant Development-II (BSID-II) in the same group of infants who were born very preterm.~   "
128525|NCT01373164|"~     Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with~     gemcitabine in patients with solid malignancy~      Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable~     pancreatic cancer when treated with a combination of LY2157299 and gemcitabine with that of~     gemcitabine plus placebo.~   "
128526|NCT01373151|"~     The purpose of this study is to determine the effective dose of BMS-945429 in subjects with~     inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid~     Arthritis.~   "
128527|NCT01373138|"~     This is an open label randomised, 2-way crossover, comparative bioequivalence study.~   "
128528|NCT01373125|"~     The investigators propose a study comparing the morphological and functional aspects of the~     neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)~     to that of native squamous epithelium in normal controls as well as gastroesophageal reflux~     disease (GERD), non-Barrett's Esophagus (BE) subjects.~   "
128529|NCT01373112|"~     Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold~     standard treatment is two-stage removal of the prosthesis with later replacement of~     permanent implants. The first stage consists of removal of the infected arthroplasty~     components and the surrounding devitalized tissue, copious pulsed irrigation, and placement~     of a temporary antibiotic-impregnated cement spacer. This spacer typically is left in place~     six weeks, during which time the patient receives intravenous antibiotics. After the surgeon~     feels that the infection has been eradicated, or if the patient requires repeat debridement,~     a second operative procedure is performed. While the use of an antibiotic-loaded spacer is~     well accepted, whether the spacer should immobilize the knee (a so-called static spacer)~     or allow for range of motion (a so-called articulating spacer) is controversial.~     Proponents of articulating spacers argue that they prevent scarring of the musculature~     surrounding the knee resulting in easier reimplantation, improved long-term knee function,~     and improved range of motion. Proponents of static spacers argue that immobilization of the~     periarticular soft tissues aids in clearance of the infection and is simpler to fashion~     intraoperatively. While good results have been described with both methods, comparative~     trials have been conflicting as to whether spacer design alters knee function, operative~     time, and range of motion. Equipoise exists within the literature, and no randomized~     clinical trial has been conducted to evaluate this issue.~      The purpose of this study is to compare articulating and static antibiotic-impregnated~     spacers for the treatment of chronic periprosthetic infection complicating total knee~     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are~     to determine the effect of spacer design upon eradication of infection, knee function, ease~     of reimplantation, and range of motion. The investigators hypothesize that articulating~     spacers will provide shorter operative times at reimplantation, while improving knee~     function and range of motion.~   "
128544|NCT01372917|"~     The study is a prospective multi-centered cohort study designed to determine the safety and~     efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the~     study is designed to determine if sterility of human acellular dermal matrix results in a~     lower incidence of infection and seroma. The study will determine if gamma radiation, as a~     method of terminally sterilizing human acellular dermal matrix, has a negative impact on~     graft incorporation into the host tissue.~   "
128570|NCT01372579|"~     This phase II trial studies how well giving eribulin mesylate and carboplatin together~     before surgery works in treating patients with stage I-III triple-negative breast cancer.~     Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~   "
128530|NCT01373099|"~     Infection remains one of the most difficult-to-treat complications of total hip~     arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later~     replacement of permanent implants.The first stage consists of removal of the infected~     arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation,~     and placement of a temporary antibiotic-impregnated cement spacer. This spacer is typically~     left in place six weeks, during which time the patient receives intravenous antibiotics.~     After the surgeon feels that the infection has been eradicated, or if a second debridement~     is required, a second operative procedure is performed. While the use of an antibiotic~     spacer is well accepted, whether the spacer should immobilize the hip (a so-called static~     spacer) or allow for range of motion (a so-called articulating spacer) is controversial.~     Proponents of static spacers argue that immobilization of the periarticular soft tissues~     aids in clearance of the infection and that these spacers are simpler to fashion~     intraoperatively. Proponents of articulating spacers argue that they improve hip function,~     prevent damage to the musculature surrounding the hip, allow easier reimplantation, improve~     hip function, and prevent dislocation following hip reimplantation. While good results have~     been described with both methods, comparative trials have been conflicting as to whether~     spacer design alters hip function, operative time, and dislocation rates. Equipoise exists~     within the literature, and no randomized clinical trial has been conducted to evaluate this~     issue.~      The purpose of this study is to compare articulating and static antibiotic-impregnated~     spacers for the treatment of chronic periprosthetic infection complicating total hip~     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are~     to determine the effect of spacer design upon eradication of infection, hip function, ease~     of reimplantation, and dislocation rates. The investigators hypothesize that articulating~     spacers will provide shorter operative times at replantation while improving hip function~     and hip dislocation rates following hip reimplantation.~   "
128531|NCT01373086|"~     This study will assess the efficacy and safety of LFF269 compared to placebo after treatment~     in subjects with essential hypertension.~   "
128532|NCT01373073|"~     The purpose of this study is to assess growth of preterm infants fed human milk supplemented~     with an experimental human milk fortifier.~   "
128533|NCT01373060|"~     This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of~     ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.~   "
128534|NCT01373047|"~     The purpose of this study is to collect data on the safety and potential effectiveness of~     2nd generation designer T cells delivered into the hepatic circulation in patients with~     liver metastases expressing the CEA tumor marker. Designer T cells are prepared by~     collecting white blood cells from the participant, and then modifying these cells in the~     laboratory so that they recognize the tumor antigen, CEA. These modified cells are then~     given back into the participant so that they can attack and kill tumor cells. The~     investigators hypothesize that regional delivery of the designer T cells directly into the~     hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic~     effect.~   "
128535|NCT01373034|"~     The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea~     predominant irritable bowel syndrome.~   "
128536|NCT01373021|"~     The purpose of this study is to determine whether additional Dexmedetomidine to patient~     controlled analgesia can reduce fentanyl consumption.~   "
128537|NCT01373008|"~     Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly~     treated with inhaled steroids, an optional treatment according to textbooks and guidelines .~     However, the evidence supporting this treatment in spontaneously breathing infants is~     limited, and based on only two randomized, placebo-controlled trials (RCT) with relative~     small number of infants . The Cochrane review concluded that these studies do not allow firm~     conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants .~     Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of~     inhaled steroids in infants with BPD. Because of its physical properties that theoretically~     make QVAR an attractive therapy in infants and studies showing it to be as effective as and~     with similar safety profile as other inhaled steroids in children, the investigators~     hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.~   "
128538|NCT01372995|"~     The increasing rate of hospital-acquired infection and antibiotic resistance are major~     causes of prolonged ICU stay and death in hospitalized patients. The enormous impact of~     ICU-related infection demands the need for cost-effective therapies that can be rapidly~     implemented to improve patient immune response to control infection. Unfortunately, little~     high-quality comparative effectiveness research has been performed on micronutrient~     treatment regimens as methods to decrease hospital-acquired infection in critically ill~     patients. Critically ill medical and surgical patients have an extremely high prevalence of~     vitamin D insufficiency.~      We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in~     ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two~     doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin~     D). The primary endpoint is to test whether high-dose regimens [either 50,000 or 100,000~     international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total~     dose = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a~     desirable range (> 30 ng/mL).~   "
128539|NCT01372982|"~     The purpose of this study is to compare bioavailability in healthy, post menopausal women~     subjects under fed conditions.~   "
128540|NCT01372969|"~     The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem~     cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.~   "
128541|NCT01372956|"~     This is a multi-centre, cross-sectional, chart review study to investigate cholesterol goal~     attainment rates defined by modified NCEP-ATP III guidelines and define its possible~     determinants among Korean dyslipidemic patients~   "
128542|NCT01372943|"~     CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which~     may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse.~     Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. Stool~     transplant (infusing donor stool into the intestine of the recipient), is not very~     palatable to either patient or medical personnel. The investigators will isolate intestinal~     bacteria from donor stool and use this purified mixture of donor bacteria instead of stool~     transplant. The investigators hypothesize that this cleaner mixture of purely isolated~     intestinal bacteria from a healthy donor would be equally effective as conventional fecal~     bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and~     anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora~     reconstitution. However our approach would provide a more controlled, reproducible, cleaner~     and more aesthetically acceptable method of administration, and from a patient safety~     perspective, would also be a safer strategy than using freshly defecated donor fecal matter.~   "
128543|NCT01372930|"~     Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin~     concentration after myocardial infarction/reperfusion and also beneficial for the patients~     undergoing percutaneous coronary intervention (PCI).~   "
128545|NCT01372904|"~     Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant~     neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung~     cancers.~      One of the common side-effects of this drug is bilateral, symmetric, progressive and usually~     irreversible sensorineural hearing loss.~      Cisplatin induces cochlear toxicity by the production of reactive oxygen species (ROS).~      Dexamethasone treatment is currently practiced for various pathologies afflicting the inner~     ear. The positive effect of Dexamethasone is attributed to it's anti ROS activity and it's~     capability to up-regulate cochlear anti ROS enzymes.~      In order to reach higher inner ear concentration of the drug while avoiding it's undesirable~     systemic side-effects, Intratympanic (IT) delivery of Dexamethasone became vastly used in~     the last decades for the treatment of sudden sensorineural hearing loss and Meniere's~     disease.~      Dexamethasone inserted IT, diffuse across the round window into the inner ear perilymph~     where it exerts its therapeutic effects.~      The investigators review of the literature yielded three animal studies which examined the~     protective effect of IT dexamethasone in the prevention of cisplatin-induced hearing loss.~     These studies demonstrated promising results pointing to the potential for IT dexamethasone~     in the prevention of cisplatin ototoxicity in humans.~      The purpose of this study is to examine possible protective effect of IT dexamethasone on~     cisplatin-induced hearing loss, in humans.~      The study hypothesis is that IT dexamethasone treatment would prevent cisplatin-induced~     hearing loss.~   "
128546|NCT01372891|"~     The present study is to determine the ability of urinary total adiponectin and its isoforms~     excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing~     PCI.~   "
128547|NCT01372878|"~     This study was design to establish the effectiveness of PillCam® Platform with the PillCam®~     COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to~     optical colonoscopy.~   "
128548|NCT01372865|"~     The primary objective will be to compare the impact of the study formulations on alergic~     rhinitis carriers.~   "
128549|NCT01372852|"~     The objective of present study were to compare plasma adiponectin isoform status, their~     bioactivities newly diagnosed Chinese with healthy volunteer.~   "
128550|NCT01372839|"~     Compare with regular regimen, the aim of this study is to testify whether having more statin~     during PCI will benefit in Chinese population, and to find out optimal dose of the drug for~     patient after PCI.~   "
128551|NCT01372826|"~     This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal~     impairment compared to that in subjects with normal renal function.~   "
128552|NCT01372813|"~     Background:~        -  One way tumors are able to grow is by forming new blood vessels that supply it with~          nutrients and oxygen.~        -  Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface~          of tumor and blood vessel cells that are involved with the formation of new blood~          vessels.~        -  Blocking these proteins may prevent the tumor cells or blood vessels from continuing to~          grow.~      Objectives:~        -  To determine whether vandetanib can cause tumors to shrink or stabilize in patients~          with advanced kidney cancer.~        -  To determine how vandetanib may work in people with kidney cancer and to develop tests~          that may be helpful in studying kidney cancer.~      Eligibility:~      -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has~     worsened after treatment with one or more of the following drugs: sunitinib, sorafenib,~     interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs~     due to unacceptable side effects; or patients who are unable to receive standard treatment.~      Design:~        -  Patients take a vandetanib pill once a day in 28-day cycles.~        -  Patients are followed in the clinic every 2 weeks during the first month of treatment~          and then every 4 weeks for a physical examination, blood and urine tests,~          electrocardiogram and a review of any drug side effects.~        -  Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging~          (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at~          tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and~          again about 4 and 8 weeks after starting treatment~        -  Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done~          before starting vandetanib treatment and after 4 weeks of treatment to look for drug~          effects on the tumor.~   "
128553|NCT01372800|"~     Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as~     a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will~     focus on serum adiponectin concentration, activity and isoforms in Chinese population and~     its correlation to these diseases.~   "
128554|NCT01372787|"~     This clinical trial studies the quality of life and care needs of patients with persistent~     or recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer. Studying quality~     of life in patients with cancer may help determine the effects of gynecologic cancer and may~     help improve the quality of life for future cancer survivors.~   "
128555|NCT01372774|"~     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor~     cells. It is not yet known whether stereotactic radiosurgery is more effective than~     whole-brain radiation therapy in treating patients with brain metastases that have been~     removed by surgery.~      PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works~     compared to whole-brain radiation therapy in treating patients with brain metastases that~     have been removed by surgery.~   "
128556|NCT01372761|"~     The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and~     effective.~   "
128557|NCT01372748|"~     The primary aim of the trial is to compare survival to hospital discharge after continuous~     chest compressions (CCC) versus standard American Heart Association (AHA) recommended~     cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients~     with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the~     rate of survival to hospital discharge is not affected by use of continuous compressions~     with passive or positive pressure ventilation (intervention group) versus CPR with~     compressions interrupted for ventilation at a ratio of 30:2 (control group).~   "
128569|NCT01372592|"~     The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data~     collection initiative, to capture clinical and radiographic outcomes in candidates for spine~     surgery with degenerative, deformity, and traumatic pathologies. As an observational~     database, there are no initial driving hypotheses, but rather data will be mined to answer~     unforeseen questions, but which may include broad topics such as comparative effectiveness~     between and among various surgical treatment options, and/or outcomes in various subgroups~     of patients such as defined by demographics, comorbidities, indications and symptoms,~     treatment variables, and/or outcome variables.~   "
129283|NCT01363206|"~     The study is an open-label, single arm single Center Phase II study to evaluate the safety~     and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF,~     Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic~     malignant melanoma.~   "
128558|NCT01372735|"~     The current standard treatment for patients with primarily resectable pancreatic tumors~     consists of surgery followed by adjuvant chemotherapy. But even in this prognostic~     favourable group, long term survival is disappointing because of high local and distant~     failure rates. Postoperative chemoradiation has shown improved local control and overall~     survival compared to surgery alone but the value of additional radiation has been questioned~     in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition~     of radiation therapy considering the high rates of microscopically incomplete resections~     after surgery. As postoperative administration of radiation therapy has some general~     disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in~     terms of dose escalation, reduction of toxicity and patients comfort especially if~     hypofractionated regimens with highly conformal techniques like intensity-modulated~     radiation therapy are considered.~      Therefore the NEOPANC trial has been designed as a prospective, one armed single center~     study to investigate a combination of neoadjuvant short course intensity-modulated radiation~     therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy)~     followed by adjuvant chemotherapy according to german treatment guidelines in patients with~     primarily resectable pancreatic cancer. The primary objectives of the NEOPANC trial are to~     evaluate the general feasibility of this approach and the local recurrence rate after one~     year. Secondary endpoints are progression-free survival, overall survival, acute and late~     toxicity, postoperative morbidity and mortality and quality of life.~   "
128559|NCT01372722|"~     Hypothesis to be tested:~      Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and~     statistically significant improvement in patients with treatment resistant bipolar disorder.~      Overall Objective:~      The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety~     and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the~     Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.~   "
128560|NCT01372709|"~     This is a prospective observational post-market study of subjects receiving the Ovation™ or~     Ovation Prime™ Abdominal Stent Graft System (Ovation™ or Ovation Prime™ Abdominal Stent~     Graft System Post-Market Study) in the treatment of abdominal aortic aneurysms (AAA). The~     Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to~     expand the clinical knowledge base by collecting data on subjects treated with the Ovation™~     or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following~     commercial approval.~   "
128561|NCT01372696|"~     The purpose is to investigate whether polyps that look different at colonoscopy, have formed~     via different mutations and have different risks of turning into cancer.~   "
128562|NCT01372683|"~     This study is designed to test the hypothesis that on an equivalent calorie basis, oat based~     breakfast cereals do not provide the same satiety benefit. The study will also demonstrate~     the satiety comparison of the cereals related to product density.~   "
128563|NCT01372670|"~     The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment~     of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with~     an eating disorder who are underweight. The investigators want to find out if hydroxyzine~     given before meals will improve meal-related anxiety compared to no hydroxyzine.~   "
128564|NCT01372657|"~     Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement~     methods before and after cataract surgery improved formulas are tried be developed.~   "
128565|NCT01372644|"~     Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast~     cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The~     investigators have previously shown insulin-like growth factor-I (IGF-I) is required to~     permit estrogen (E2) and progesterone action in the mammary gland, and that a novel~     somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary~     gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary~     gland. This study was designed to determine whether women at high risk for breast cancer~     respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal~     hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with~     SOM230 (600mcg BID). Surgical excision was performed on day 10. Sections were examined~     before and after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum~     IGF-I, fasting glucose, insulin, and HbA1C were measured in anticipation of changes.~   "
128566|NCT01372631|"~     The goal of this research is to further develop novel optical assay systems for intra~     operative assessment of tumor margins in partial mastectomy or mastectomy specimens.~   "
128567|NCT01372618|"~     This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230)~     in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are~     used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in~     reducing the occurrence of invasive breast cancer. Unfortunately, treatment with~     antiestrogens carries potential serious side effects and toxicities that are intolerable to~     some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will~     be at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents~     mammary development by inhibiting IGF-1 action directly in the mammary gland and also~     indirectly without causing menopausal symptoms. This study is an expansion of work that we~     have previously done in women with atypical hyperplasia of the breast, which showed that~     treatment with pasireotide for 10 days caused a reduction in the cellularity of these~     precancerous lesions. In our present study, women with DCIS will be treated with pasireotide~     for 20 days prior to surgical excision. Endpoints will be as follows:~        1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis~          (signs of tumor growth), and stimulate apoptosis (cell death) in surgically excised~          tissue in comparison to core biopsies from women with estrogen receptor (ER) positive~          DCIS. Both the core biopsy and surgical excision are standard of care procedures that~          women with DCIS have regardless of participation in this trial.~        2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with~          pasireotide and evaluate for changes in tumor volume and other tumor related features~        3. In our previous study we found that many women experienced a slight elevation in blood~          sugar with 10 days of treatment with pasireotide. Other work has shown that this effect~          often resolves with greater duration of treatment. We are therefore expanding the~          duration of treatment in this study to 20 days to assess if the initial hyperglycemia~          seen with pasireotide improves as treatment duration progresses.~   "
128568|NCT01372605|"~     This project will integrate a depression treatment and brief medication adherence counseling~     intervention into clinical care at three HIV clinics and will use a randomized controlled~     trial to assess whether, relative to usual care, the intervention leads to improved HIV~     medication adherence. The depression treatment intervention uses a model known as~     Measurement-Based Care which equips Depression Care Managers with systematic measurement~     tools, a decision algorithm, and psychiatric backup and trains them to provide decision~     support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.~   "
128571|NCT01372566|"~     The goal of this study is to assess the safety, tolerability and effectiveness of platelet~     rich plasma in the treatment of photoaged skin. This study will be divided into two parts.~     The first part will assess the safety and tolerability of platelet rich plasma injections as~     compared to sterile saline injections in subjects' arm with six months follow-up. The second~     part will assess the effect of platelet rich plasma on the appearance of facial skin in a~     split face study with platelet rich plasma injections on one side of the face and sterile~     saline on the other. Outcomes will be recorded for twelve months.~   "
128572|NCT01372553|"~     -  Genomic medicine, using genetic information to improve health outcomes, is heralded as~          the answer to rising medical costs by focusing on prevention and tailored care. Despite~          its potential, little investigation has focused on how genomic medicine can be applied~          in health care. To be effective, it requires new ways to learn, deliver, and~          communicate medical information. It will also raise new ethical questions.~        -  The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the~          specific challenges in re-structuring an existing medical system to integrate genomic~          medicine, and create solutions that can be used by other medical systems, such as the~          extensive military medical care system. To accomplish this goal, GGMI includes the~          development of a large-scale genomic medicine education initiative targeted at the~          community, providers, and patients, and a clinical systems model to implement~          strategies to facilitate the integration of genomic medicine into several pilot~          practices.~   "
128573|NCT01372540|"~     This study is divided into study groups, as described below. The goal of Groups 1A and 2A of~     this clinical research study is to find the highest tolerable dose of the combination of~     ARRY-520 and carfilzomib that can be given to patients with multiple myeloma or plasma cell~     leukemia.~      The goal of Groups 1B and 2B of this study is to learn if the combination of carfilzomib and~     ARRY-520 can help to control multiple myeloma or plasma cell leukemia. Researchers would~     also like to learn if ARRY-520 can help carfilzomib to work in patients who have built up a~     resistance to carfilzomib or carfilzomib alone has not helped to control the disease.~      The safety of the study drugs will be studied in all groups.~   "
128574|NCT01372527|"~     Although there is considerable evidence that current health IT can improve certain elements~     of care, the most effective and efficient implementation of health IT systems for primary~     care population management are not currently known. Indeed, while many systems currently~     take a case-management approach to identify and address clinical care issues for high risk~     patients, no systems to our knowledge apply a risk-based approach that accounts both for~     adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated~     screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific~     patient will ignore a reminder letter and would therefore benefit from direct phone or in~     person contact). The investigators propose to directly test the hypothesis that implementing~     a health IT platform that 1) provides novel risk-based decision support using data derived~     from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge~     of his or her patient panel will result in more effective and more efficient~     population-based primary care. The investigators will test this hypothesis in a~     practice-randomized clinical trial of preventive cancer screening within our primary care~     Practice-Based Research Network (PBRN).~   "
128575|NCT01372514|"~     The purpose of this study is to create an institutional registry of Thromboembolic disease~     through a prospective survey based on epidemiological data, risk factors, diagnosis,~     prognosis, treatment, monitoring and survival.~      The main goal is to describe the occurrence of thromboembolic disease and the~     characteristics of clinical presentation, evolution and predisposing factors of these~     episodes in the population of the Hospital Italiano de Buenos Aires.~   "
128576|NCT01372501|"~     The purpose of this study is to determine whether the GI Endobarrier Liner can be~     reimplanted.~   "
128577|NCT01372488|"~     1. Hypothesis~           If patients who are sutured with non-absorbable sutures in the Emergency Department~          (ED) are provided with the proper equipment and knowledge on how to remove their own~          sutures, they will be willing and capable of removing their own sutures.~        2. Primary and Secondary Questions~      Primary Question What number of patients in the study group will successfully remove their~     own sutures if they are provided with the equipment and information on how to do so compared~     with a control group who are treated and advised in the usual fashion? (follow up with~     family doctor or local medical clinic for suture removal)~      Secondary Questions~        1. Number of complications related to self removal of sutures as compared to traditional~          treatment. Complications measured were wound infections, dehiscence and prolonged~          bleeding (>30 min)~        2. Number of physician visits related to self removal of sutures as compared to~          traditional treatment.~        3. Patient satisfaction and comfort level related to self removal of sutures as compared~          with traditional treatment.~   "
128578|NCT01372475|"~     Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a~     new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS]~     in subjects with symptomatic osteoarthritis of the knee.~   "
128579|NCT01372462|"~     Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive~     Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe~     Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during~     constant work rate exercise in subjects with severe COPD.~   "
128580|NCT01372449|"~     This study will attempt to study the effect of memantine, on memory, and motor~     praxis/expressive language skills in children with autism.~      The investigators will recruit children ages 6-12 years who are verbal and meet criteria for~     Autism Spectrum Disorder. The children will be assessed for memory function, expressive~     language output and motor skills/praxis. They will then be randomized to memantine or~     placebo for 6 months. The effects of this medication and its safety in this population will~     be studied over the 6 month period.~   "
128616|NCT01371981|"~     This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in~     treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib~     tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and~     sorafenib tosylate together with combination chemotherapy may be an effective treatment for~     acute myeloid leukemia.~   "
128581|NCT01372436|"~     Identification of caries high risk subjects. Studying the relevance and the distribution of~     caries risk factors as defined by the HAS, and the part played by the zone of schooling~     (priority education area or not) Studying the interest of bacteriological tests using the~     technique of real-time PCR and the laser fluorescence device in the caries risk assessment~     Thanks to a prospective cohort study conducted over a period of 4 years on a representative~     sample of pupils and students chosen at random from the 360 primary schools and 89 high~     schools in the Alpes Maritimes (678 subjects).~   "
128582|NCT01372423|"~     The objective of this study is to evaluate the clinical equivalence and safety of the Test~     formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA®~     (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed~     chronic idiopathic constipation.~   "
128583|NCT01372410|"~     The purpose of this study is to further characterize the dose response of GSK573719 at doses~     of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive~     pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be~     included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily~     via the Handihaler will be included as an active control. A placebo treatment will be~     included in order to evaluate absolute treatment effect of the different doses of GSK573719.~   "
128584|NCT01372397|"~     The overall purpose of this study is to determine if weight loss is beneficial for obese~     patients with diastolic heart failure.~   "
128585|NCT01372384|"~     This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients~     with locally advanced, metastatic or recurrent non-small cell lung cancer who have not~     received previous chemotherapy for their disease and who present epidermal growth factor~     receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease~     progression or unacceptable toxicity occurs.~   "
128586|NCT01372371|"~     Hypothesis: Directly applying antibiotic powder onto the site of surgery along with~     perioperative intravenous antibiotics, before closing the wound, is more effective than~     intravenously applied perioperative antibiotics alone in controlling post-operative wound~     infection. The investigators also think powders that control both gram positive and gram~     negative bacteria are more beneficial.~   "
128587|NCT01372358|"~     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000~     mg ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals~     Corporation in healthy, adult, non-smoking subjects under non-fasting conditions.~   "
128588|NCT01372345|"~     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000~     mg ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals~     Corporation in healthy, adult, non-smoking subjects under fasting conditions.~   "
128589|NCT01372332|"~     The purpose of this explorative study, targeting subjects with homonymous visual field loss,~     is threefold:~      (i) to identify the perimetric / psychophysical method, that is most closely correlated with~     an individually assessed quality of life (QoL) score, using a validated questionnaire~     (NEI-VFQ 25) (ii) to determine, whether gaze-related (exploratory eye movements) or visual~     field-related (eyes steadily fixating) parameters are better for the characterization of the~     visual capacities that are necessary for activities of daily living (ADL), as represented by~     (iia) a standardized visual search task (supermarket special offer search task) (iib) by~     an on-road car driving pilot study.~   "
128590|NCT01372319|"~     The purpose of this explorative study, targeting subjects with advanced binocular~     glaucomatous visual field loss, is: (i) to identify the perimetric / psychophysical method,~     that is most closely correlated with an individually assessed quality of life (QoL) score,~     using a validated questionnaire (NEI-VFQ 25), (ii) to determine, whether gaze-related~     (exploratory eye movements) or visual field-related (eyes steadily fixating) OR~     attention-related parameters are better for the characterization of the visual capacities~     that are necessary for activities of daily living (ADL), as represented (iia) by a~     standardized visual search task and (iib) by an on-road car driving feasibility study.~      Further this study is intended to introduce and analyse a novel diagnostic method for~     recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical~     setting. A similar procedure has recently been introduced by Murray et al. However, their~     set-up is based on a video monitor and, therefore, restricted to the central visual field~     (eccentricity < 25°) and limited with regard to the dynamic range of the stimulus luminance.~     Since our new gaze-related perimetry is designed to be implemented in a conventional cupola~     perimeter, it should be widely available as a potent diagnostic tool, for screening~     purposes, or for clinical surveys by general ophthalmologists or clinical research groups.~   "
128591|NCT01372306|"~     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.~   "
128592|NCT01372293|"~     An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify~     for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has~     been suggested in previous studies.~      Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors,~     the investigators hypothesis is that women with PCOS and with the variant allele G have a~     poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive~     pill (OCP) treatment for 6 months.~   "
128593|NCT01372280|"~     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting~     condition.~   "
128617|NCT01371968|"~     This study aims to determine the optimal dose of alfentanil in suppressing the airway~     reflexes during supreme LMA removal in anaesthetized adult.~   "
128618|NCT01371955|"~     The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the~     investigators choose to look about some oxidative stress genes. Today a one-gene explanation~     is not really possible. So the theory of some genetic predisposition to DN is more likely.~      The aim of the study is to look about the association of the C282T polymorphism of P22phox,~     a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the~     occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also~     investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation~     end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX~     12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last~     polymorphism is correlated to albuminuria in diabetic patients.~   "
128594|NCT01372267|"~     The present intervention is a Stage II randomized controlled efficacy trial of a group-based~     intervention that integrates Cognitive Behavioral Therapy (CBT) for pain and substance use~     disorders (SUDs) compared to a Supportive Psychoeducation Control (SPC) group in a sample of~     patients receiving residential SUD treatment with co-occurring chronic pain. A total of 452~     patients (226 male and 226 female) with current pain rated as moderately severe or greater~     and comorbid drug or alcohol use disorder(s) will be recruited from a large residential SUD~     treatment program. These participants will be randomly assigned to either a 4-week~     (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All~     participants will be re-assessed immediately post-treatment (1 month) and again at 3, 6, and~     12 months post-intervention. Through this randomized controlled trial, the investigators~     hope to gain insight on how to improved treatment of pain in those with SUDs that could~     result in enhanced quality of life and improved pain-related, substance use, and other~     health outcomes. Evaluating a psychosocial intervention for pain and substance use that can~     be delivered during a SUD treatment episode would significantly extend available treatment~     options for the large numbers of patients with pain seen by SUD treatment providers. The~     investigators also hope to determine the efficacy of an evidence-based psychosocial pain~     management approach in men and women from a large and diverse residential addiction~     treatment program.~   "
128595|NCT01372254|"~     The objective of the proposed project is to develop a novel, behavioral approach to smoking~     cessation that can be integrated with residential drug use treatment for low income~     substance using smokers with elevated depressive symptoms. The approach utilizes behavioral~     activation strategies which have been shown to reduce smoking among community samples and~     which can be easily targeted for the particular needs of low income substance users.~   "
128596|NCT01372241|"~     The purpose of this study is to determine whether a faith-placed lay health advisor~     intervention is effective in increasing use of Pap smears among middle-aged and older~     Appalachian women.~   "
128597|NCT01372228|"~     The goal of this research study is to establish chimerism and avoid~     graft-versus-host-disease (GVHD) in patients with inherited metabolic disorders.~   "
128598|NCT01372215|"~     In this study, participants, who are scheduled to have a breast biopsy, will have several~     extra spot mammogram images taken of the suspicious area. These images will be acquired with~     varying levels of compression. The images will then be analyzed to determine whether the~     type of lesion (malignant or benign) can be determined from the image data alone. The biopsy~     results will be used as a gold standard to determine the true malignancy status~   "
128599|NCT01372202|"~     This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum~     Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status~     in Diagnostic Biopsies.~   "
128600|NCT01372189|"~     The study aims to:~        1. Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using~          confocal laser endomicroscopy.~        2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo~          immunohistochemistry .~   "
128601|NCT01372176|"~     An increasing number of patients survive critical illness and intensive care, but describe~     having impaired physical function several years after discharge as a consequence of~     extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are~     multiple, but insufficient nutrition is likely to contribute.~      This randomised trial will investigate the effect of an optimised nutrition therapy during~     intensive care, on short term clinical outcome and physical quality of life. We hypothesise,~     that early nutritional therapy, directed towards patient-specific goals for energy and~     protein requirements, will improve both short- and long-term outcomes.~   "
128602|NCT01372163|"~     The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after~     administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to~     evaluate the plasma drug concentrations after multiple doses.~   "
128603|NCT01372150|"~     This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release~     vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive~     Disorder (MDD).~   "
128604|NCT01372137|"~     This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to~     identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in~     patients with anemia of chronic disease (inflammation).~   "
128605|NCT01372124|"~     This is a multi center, open label, parallel group, single administration, phase I trial, in~     subjects with mild, moderate or severe renal impairment and a control group with normal~     renal function.~   "
128606|NCT01372111|"~     Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for~     treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC),~     though many clinical questions remain. Prior experience has revealed locoregional control~     (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after~     treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and~     concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This~     multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL)~     and toxicity profile. The current trial is an attempt to maintain high LRC, while further~     minimizing both acute and chronic toxicities, and maximizing QOL.~   "
128607|NCT01372098|"~     The purpose of this study is to determine whether the Intimate Partner Violence (IPV)~     intervention in the context of Nurse-Family Partnership (NFP) program improves women's~     quality of life and reduces violence relative to the NFP alone using a cluster randomized~     controlled trial. Our hypothesis is that an IPV intervention can be designed that is~     acceptable to participants in the NFP, feasible to implement, and that this intervention~     will improve quality of life for women and reduce exposure to violence.~   "
128608|NCT01372085|"~     This is a single-centre, placebo-controlled, two-part study in healthy subjects.~      Part A will be a single dose, single period, placebo-controlled pilot study to explore the~     safety, tolerability, absorption and pharmacodynamic (effect of drug on a biological~     marker-pS6 levels in skin biopsies) of a single dose of 25 mg LY2584702 Reference~     formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to~     primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF)~     of LY2584702.~   "
128609|NCT01372072|"~     Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an~     important mode of treatment in patients with both acute and chronic respiratory (breathing)~     failure. Humidification is widely accepted as an essential part of the ventilation strategy~     in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but~     its role during NIV use is not proven. Consequently, there is a variation in practice with~     regard to humidification during NIV. Humidification is important in maintaining upper and~     lower airway mucosal function and patients requiring NIV often report symptoms, such as~     throat dryness, due to a lack of airway humidity. Success of NIV in the acute setting is~     dependent on many factors including, patient tolerance of NIV during the acute phase. In~     patients with chronic obstructive airways disease (COPD), poor tolerance results in NIV~     failure, which necessitates endotracheal intubation or treatment failure. Furthermore,~     invasive ventilation increases the risk of a hospital acquired pneumonia, which is~     associated with a worse outcome. In the long term setting of NIV use, again patients~     frequently report symptoms due to drying of the airways and adherence to NIV can be highly~     variable. Adherence in these patients is important in improving both quality and length of~     life. Humidification devices may be technically effective, but clinicians have concerns~     regarding potential negative effects of these devices. There is a requirement to evaluate~     the use of humidification in both the acute and long term use of NIV, particular, in terms~     of patient ventilator interaction, which will impact on comfort and adherence to NIV. This~     will effect the overall effectiveness of ventilation. The investigators propose a randomised~     controlled trial to investigate the effects of a humidification system during noninvasive~     ventilation.~   "
128610|NCT01372059|"~     The initiative to the study is based on the fact that various forms of enriched environments~     and multimodal stimulation are found to have positive influences on motivation and~     psychosocial well-being and have been shown to facilitate multiple processes in the brain~     leading to structural regeneration and functional recovery. Since there is a lack of~     rehabilitation programs that encompass all dimensions of a stroke survivor's life~     researchers agree upon the need for a rehabilitation program that addresses both the social~     and physical needs of the patients. The aim with the project is to investigate whether it is~     possible to improve the life situation among patients with a history of stroke through a~     rhythm and music method and therapeutic riding. To get insights in the underlying mechanisms~     our research also focuses on relevant physiological, neurobiological and psychosocial~     mechanisms induced by the interventions. The hypothesis is that both treatment methods will~     mainly enhance participants' degree of participation.~      The study is a randomized controlled trial where about 123 participants (50-75 years old)~     who had their stroke incident 1 - 5 years ago will be consecutively included and randomly~     allocated to the following three groups: a) Ronnie Gardiner Rhythm Music Method (RGRM) b)~     therapeutic riding c) a control group receiving RGRM after 9 months. Treatment proceeds~     during 12 weeks and evaluation takes place pre- and post intervention, and 12 and 24 weeks~     after the treatment is finalized. The evaluation consists of a thorough neuropsychological~     assessment, a physiotherapeutic assessment, sampling of blood and questionnaires covering~     mental, psychosocial, physical and psychological well-being. Interviews are also conducted~     in order to map the participants' experiences from the two treatment programs. Specially~     designed interviews are also planned to be carried through with participants having aphasia.~      So far, there is only empirical support suggesting that RGRM has positive effects for~     individuals with a history of stroke making it significant to carry out research with the~     aim to contribute to strengthening the evidence of the method. A positive outcome would~     increase the scientific basis for this alternative treatment thus facilitating further~     research and implementation in everyday clinical practice.~   "
128611|NCT01372046|"~     1. Assess the impacts of implementing a juvenile assessment, referral, placement, and~          treatment planning (J-ARPP) protocol, and of different strategies for transferring~          J-ARPP technology, on service utilization of youth entering the juvenile justice~          system.~        2. Assess the impacts of implementing J-ARPP, and of different strategies for transferring~          J-ARPP technology, on measures of organizational readiness and motivation, and staff~          attitudes about assessment and service.~        3. Assess the impacts of implementing J-ARPP, and of different strategies for transferring~          J-ARPP technology, on measures of systems integration.~        4. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the~          J-ARPP protocol and service utilization of youth entering the juvenile justice system.~   "
128612|NCT01372033|"~     The specific aims of this project are:~        1. To conduct a randomized block experiment to test the effectiveness of different models~          of the seamless supervision/treatment system and traditional criminal justice~          supervision on reducing recidivism and drug use, and improving social adjustment among~          offenders;~        2. To understand the differential impacts based on offender risk factors (e.g., propensity~          to engage in further criminal behavior) on criminal justice outcomes and to determine~          whether differences found between seamless and traditional system participants are~          moderated by offender risk level;~        3. To understand differential treatment and social adjustment outcomes (e.g., treatment~          progress, employment status) of different types of offenders participating in various~          treatment services; and~        4. To examine levels of systems and service integration between the supervision and~          treatment systems pre- and post-intervention and to measure the impact of integration~          on outcomes over time.~   "
128613|NCT01372020|"~     The use of neuromuscular electrical stimulation in the treatment of venous ulcers with~     difficulty of repair could be an alternative therapeutic favoring devitalized tissues and~     hence the pain.~      The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on~     pain and area of venous ulcers in patients with venous insufficiency.~   "
128614|NCT01372007|"~     Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal~     lymph nodes within the mesorectal envelope. It is becoming universally recognized and~     accepted as the standard technique for surgical excision of rectum carcinomas. TME results~     in lowest rates of local recurrence, especially when combined with pre-operative~     chemo-radiotherapy.~      Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be~     important. The quick decrease of this drainage will enable the early mobilisation of the~     patient and may shorten the time of hospitalization. If this decrease in fluid production~     can be achieved, it will have a positive effect on the Quality of Life of the patient and~     will ensure health economic savings by reduction of hospitalization time and resources.~      Somatostatin analogues have shown to be able to decrease the secretion of numerous types of~     bodily fluids.~      The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the~     fluid discharge in patients that underwent a TME for rectumcarcinoma.~      Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid~     discharge in the drain of the patient that underwent a total mesorectum excision (TME) for~     rectal carcinoma. Patient planned to have a TME will be asked to participate in the study.~     When they have provided written informed consent, they will be randomized 1:1 to receive~     either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily~     post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or~     placebo will be administered. After administration the volume of the drain fluid will be~     measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected~     every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and~     chloride analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a~     period of 5 days, this patient can not be randomized.~   "
128615|NCT01371994|"~     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of~     solifenacin succinate versus placebo in participants who are incontinent after Robotic~     Assisted Radical Prostatectomy.~      This study will also assess the effect of 12 weeks of treatment with solifenacin succinate~     versus placebo on quality of life (QOL) as measured by questionnaires.~   "
128631|NCT01371786|"~     This study is an open label, single dose, single site, randomized, cross over study that~     will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide~     radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone~     furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately~     10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.~   "
128619|NCT01371942|"~     The aim of this study is to investigate mutational changes occurring in colorectal tumors,~     from benign polyps, malignant cancer and metastatic tumors. The investigators also plan to~     establish the clinical correlation, emphasizing on aspects such as the diagnosis and~     prognosis of disease and the specific treatment outcome. For the purpose, the investigators~     plan to obtain specimens from patients with colorectal tumors to extract DNA material. The~     specimens include tissues from either primary (mostly endoscopic biopsies specimens) or~     metastatic tumors (obtained from sonogram or other imaging modalities guided biopsy), as~     well as other humors including blood (for serum), malignant ascites, pleural effusions or~     other body fluids that could be related to CRCs. These patients would receive detailed~     explanations with regard to the investigations before signing IRB consent. At the initial~     stage, Wanfang Medical Center would be the only medical institution where endoscopic~     specimens would be collected. The project would eventually be extended to the Taipei Medical~     University Hospital and Shuan-Ho Hospital.~   "
128620|NCT01371929|"~     The primary objective is to demonstrate that the plasma inducible nitric oxide synthase~     (iNOS) assay (PliNOSa® test) has an acceptable relative risk ratio for predicting the onset~     of sepsis within 72 hours of testing when performed on the first day a patient is admitted~     or transferred to the intensive care unit (ICU) and is considered to be at risk of becoming~     septic. The PliNOSa® test measures inducible nitric oxide synthase (iNOS) in plasma and uses~     a pre-determined iNOS cut-off value to identify patients at risk for the onset of the sepsis~     pathology.~   "
128621|NCT01371916|"~     Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge.~     One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not~     present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present~     study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a~     mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the~     efficiency of this antigen in the laboratory diagnosis of TBM.~   "
128622|NCT01371903|"~     Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or~     Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.~   "
128623|NCT01371890|"~     The purpose of this study is to determine the role of dialysate exposure and fluid removal~     during hemodialysis in the pathophysiology of intradialytic hypertension.~   "
128624|NCT01371877|"~     This clinical study was designed based on our hypothesis that vitamin D plays an important~     role in chronic urticaria and that high dose supplementation with vitamin D in subjects with~     chronic urticaria will improve clinical response.~      This clinical study will investigate our hypothesis in three Specific Aims:~        1. Determine whether high dosing vitamin D supplementation (4000 IU/day) reduces~          medication usage (primary outcome) and urticaria severity score (secondary outcome) in~          subjects with chronic urticaria as compared to low dosing (600 IU/day).~        2. Determine if high dosing of vitamin D (4000 IU/day) is safe and well-tolerated in~          subjects with chronic urticaria with or without baseline vitamin D deficiency.~        3. Investigate whether there is an association with serum 25-hydroxyvitamin D levels,~          vitamin D receptor mRNA expression, and chronic urticaria severity.~   "
128625|NCT01371864|"~     Purpose:~      -To evaluate the peri-operative communication between families and the pediatric cardiac~     surgery team.~      Method:~      -In this study the investigators plan to utilize structured interview and survey of~     parents/legal guardians and health care providers of children undergoing cardiac surgery in~     the United States of America.~   "
128626|NCT01371851|"~     Psychostimulant dependence is a major public health problem and no medications have been~     shown to be very effective in treating this disorder. Thus, the investigators wish to study~     whether a blood pressure drug thought to reduce drug craving through its interaction at~     particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in~     psychostimulant dependent participants enrolled in an 8-week, randomized, double blind,~     placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce~     cocaine use relative to placebo in psychostimulant dependent participants.~   "
128627|NCT01371838|"~     This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline~     Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With~     Community-Acquired Bacterial Pneumonia in Asia.~   "
128628|NCT01371825|"~     This is an open-label, repeat-dose, intra-subject dose escalation study of SBC-102 (USAN:~     sebelipase alfa) in children with growth failure due to LAL Deficiency. Eligible subjects~     will receive once-weekly (qw) infusions of sebelipase alfa for up to 5 years~   "
128629|NCT01371812|"~     The purpose of this first time into human study is to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.~   "
128630|NCT01371799|"~     This will be a double blind, randomised, placebo controlled, cross over study in which up to~     20 otherwise healthy male nicotine abstinent smokers will be tested following 3 acute~     treatment conditions (placebo, 4 and 8mg of GSK1034702). Each subject will undergo screening~     assessments within 30 days prior to administration of the first dose of study medication.~     There will be 3 treatment sessions and dosing will be separated by a minimum 1 week washout~     period. There will be two testing days (day 1 and day 2) per treatment session. On each~     treatment session subjects will be admitted on day 1. On day 1, subjects will be~     administered placebo and approximately 3 hours later, there will be a Baseline EEG/ERP~     recording, neuropsychological (Cogstate battery) testing and mood/craving/dependence~     questionnaire assessments . Subjects will be allowed to smoke until approximately midnight~     on day 1. On day 2, subjects will undergo a pre-drug neuropsychological (Cogstate battery)~     testing and questionnaire assessments of mood/craving. This will be conducted approximately~     1 hour prior to dosing. Subjects will be randomized to one of six treatment sequences. Post~     dose EEG/ERP recording, neuropsychological (Cogstate battery) testing and mood/craving~     measurements will be conducted between 3 and 6 hours post treatment to coincide with peak~     pharmacokinetic effects. This testing will be performed approximately at 12pm following at~     least 12hrs of nicotine abstinence. Blood samples will be collected at baseline (pre-drug)~     and following drug administration to quantify exposure levels.~   "
128632|NCT01371773|"~     The purpose of this study is to devise repositioning method of a left-sided double lumen~     tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.~   "
128633|NCT01371760|"~     To assess in a double blinded randomized control trial (RCT) study design safety and~     effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in~     multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).~      Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be~     randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.~   "
128634|NCT01371747|"~     This study determined the optimal starting dose of patiromer in treating hyperkalemia in~     participants with hypertension and diabetic nephropathy who were already receiving ACEI~     and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and~     safety of patiromer and the long term use of patiromer.~   "
128635|NCT01371734|"~     This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR)~     versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive~     Disorder (MDD).~   "
128636|NCT01371721|"~     This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate~     sustained release (DVS SR) in the treatment of child and adolescent outpatients with major~     depressive disorder (MDD).~   "
128637|NCT01371708|"~     This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate~     Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major~     Depressive Disorder (MDD).~   "
128638|NCT01371695|"~     The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated~     sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical~     Intraepithelial Neoplasia III (CIN III), and cervical cancer.~   "
128639|NCT01371682|"~     This is an open-label, randomised, two-period crossover, single dose study to demonstrate~     bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two~     different sites in healthy subjects. Dosing will be under fasting conditions and there will~     be a minimum one week washout between doses. Domperidone will be administered to control~     dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety~     assessments will include screening and follow-up vital signs, ECGs and safety laboratory~     tests. Vital signs and adverse events will be monitored periodically throughout the study.~   "
128640|NCT01371669|"~     In the investigators study, and regarding results of small cohorts in the literature, the~     investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators~     will explore these patients with a one night polysomnography and transcutaneous capnography,~     searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.~   "
128641|NCT01371656|"~     This randomized phase III trial studies how well levofloxacin works in preventing infection~     in young patients with acute leukemia receiving chemotherapy or undergoing stem cell~     transplant. Giving antibiotics may be effective in preventing or controlling early infection~     in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It~     is not yet known whether levofloxacin is effective in preventing infection.~   "
128642|NCT01371643|"~     This is a randomized, multicenter trial with stratification done by a single radiologist at~     the coordinating center (NYU), and patients with comparable disease will be randomized to~     Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before~     (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo~     transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to~     Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine~     whether surgery (debulking of pituitary adenomas) improves the response of patients with~     acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.~   "
128643|NCT01371630|"~     The goal of the Phase I part of this clinical research study is to test 2 dose levels of the~     drug inotuzumab ozogamycin to find the highest tolerable dose that can be given in~     combination with chemotherapy. The goal of Phase II is to learn if inotuzumab ozogamycin~     given in combination with chemotherapy can help to control ALL. The safety of the study~     drugs will also be studied.~      Inotuzumab ozogamycin is designed to attach to a protein that is often found in leukemia~     cells. This may cause the cancer cells to die.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells~     to die.~      Hyper-CVAD includes a combination of cyclophosphamide, vincristine, dexamethasone,~     methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim). The maintenance therapy used~     in this study is called POMP, which includes a combination of mercaptopurine, methotrexate,~     vincristine, and prednisone. These chemotherapy drugs are designed to interfere with the~     multiplication of cancer cells, which may slow or stop their growth and spread throughout~     the body. This may cause the cancer cells to die.~   "
128644|NCT01371617|"~     The purpose of this study is to determine the safety and efficacy of IPI-926 in patients~     with myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis~     [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]).~   "
128645|NCT01371604|"~     The purpose of this study is to assess the safety and antiviral activity of IDX184 in~     combination with pegylated interferon and ribavirin in treatment-naïve subjects with~     genotype 1 chronic hepatitis C virus (HCV) infection.~   "
128646|NCT01371591|"~     The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED~     patients with suspected upper GI hemorrhage. A prospective multicenter randomized control~     trial was designed to investigate the safety of this approach.~   "
128647|NCT01371578|"~     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response~     Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451)~     with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic~     Genotype 1 Hepatitis C Virus (HCV) Infection.~   "
128648|NCT01371565|"~     This is a compassionate use study. In addition to providing compassionate use access to~     mifepristone, objectives of the study will be to evaluate the safety and utility of~     mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome~     when given on a compassionate use basis. The study will only enroll subjects whose~     physicians have determined that medical treatment is needed to control the symptoms or signs~     of hypercortisolemia.~   "
128649|NCT01371552|"~     The purpose of this study was to compare a new daily disposable, silicone hydrogel contact~     lens to marketed daily disposable, silicone hydrogel contact lenses.~   "
128650|NCT01371539|"~     The purpose of this study was to compare visual performance measures between two multifocal~     contact lenses on presbyopic wearers.~   "
128651|NCT01371526|"~     Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune~     attack progressively destroys the adrenal cortex. Untreated it is universally fatal and~     treated people are absolutely dependent upon steroid medications lifelong, with a consequent~     excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are~     responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This~     study aims to regenerate adrenocortical steroidogenic cell function in patients with~     established autoimmune Addison's disease (AAD) by stimulating proliferation and~     differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2).~     Using daily subcutaneous ACTH, administered according to two different regimens over 20~     weeks, we will investigate whether regeneration of adrenal steroidogenic function through~     revival of ACSC activity is a realistic possibility.~   "
128652|NCT01371513|"~     This is to investigate Korean urologist's practice patterns for screening prostate cancer~     according to PSA level.~   "
128653|NCT01371487|"~     The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on~     the single dose PK of GSK1120212 in subjects with solid tumors.~   "
128654|NCT01371474|"~     The objective of this survey was to understand the safety and efficacy of PAXIL tablets~     (PAXIL, hereinafter) when it was started at 20 mg/day in subjects with depression or in a~     depressed state.~   "
128655|NCT01371461|"~     Overall improvement, severities and changes of specific clinical symptoms were surveyed in~     outpatients with depression or in a depressed state to evaluate the efficacy and safety of~     PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a~     constant dose.~   "
128656|NCT01371448|"~     This surveillance study is designed to detect adverse events (particularly clinically~     significant adverse drug reactions) occurring in clinical settings and to examine factors~     likely to affect the safety and efficacy of paroxetine in long-term use (1 year).~   "
128657|NCT01371435|"~     This post-marketing surveillance study is designed to detect adverse events (particularly~     clinically significant adverse drug reactions) occurring in clinical settings and to examine~     factors likely to affect the safety and efficacy of paroxetine.~   "
128658|NCT01371422|"~     This is a randomized control trial (meaning the selection is random as when flipping a coin)~     to assess the benefit of paravertebral blockade (PVB) in Percutaneous~     nephrolithotomy/nephrolithotripsy (PCNL) surgery.~   "
128659|NCT01371409|"~     After a stroke the excitability of the brain decreases on the stroke side and increases on~     the opposite, non-stroke side. These changes make use of the stroke-affected arm difficult~     and slow recovery. Rehabilitation exercises that increase arm use after stroke help increase~     brain excitability, but the net effect of this approach is low. New therapies are needed~     that restore more equal levels of brain excitability between the two sides. Brain~     stimulation is a noninvasive way to affect activity the excitability of brain cells. Pairing~     brain stimulation with exercises that require patients to learn new movements may help the~     brain to learn. Using stimulation that reduces activity in the side opposite to the stroke~     can increase activity on the stroke -affected side, through connections between the two~     brain hemispheres. The purpose of this study is to test if brain stimulation on the side~     opposite to the stroke, paired with arm movement exercises, can help patients learn new arm~     movements and improve arm function.~      In this study people with stroke will receive brain stimulation over two different areas on~     the side of the brain opposite to the stroke: 1) those areas responsible for movement and 2)~     those responsible for sensation. These experiments will test both the short and long term~     effects of brain stimulation on patients' learning and arm function and will allow us to~     identify which area of the brain best improves learning and arm function. These experiments~     have the potential to improve the effectiveness of rehabilitation after stroke. The proposed~     study is among the first to test stimulation over the side of the brain opposite to the~     stroke damage and at multiple sites. This unique approach may help stimulate the development~     of new methods for stroke rehabilitation.~   "
128660|NCT01371396|"~     The purpose of this study is to understand why Hispanics who are overweight have a higher~     incidence of fatty liver disease.~   "
128661|NCT01371383|"~     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3~     polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a~     double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and~     docosahexaenoic acid (DHA) on different symptom clusters in patients with depression.~   "
128662|NCT01371370|"~     -  Obesity is a major risk factor for premature arterial abnormalities including high~          blood pressure and increased stiffness. Previous studies have shown that weight loss~          via lifestyle modifications is associated with a decrease in large artery (aorta)~          stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle~          mass. Low-intensity resistance exercise training (LIRET) results in similar increases~          in muscle mass and strength than those observed after high-intensity resistance~          exercise.~        -  The investigators hypothesis is that weight loss via diet combined with LIRET would~          additively reduce arterial stiffness and blood pressure (BP) in obese women. The~          investigators also hypothesize that the improved arterial function with weight loss~          would be associated with beneficial changes in the main mechanisms involved in BP~          regulation.~   "
128675|NCT01371201|"~     The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter~     study which aims to determine the efficacy of Sunitinib on the progression-free survival at~     12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated~     with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).~   "
128676|NCT01371188|"~     Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and~     prevalent professional activity of agribusiness segment of the Brazilian economy, exposes~     workers and people of neighboring towns to high concentrations of pollutants and, therefore,~     potentially several risks to health hazards.~      Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers~     and volunteers from a nearby town in non-harvest and harvest periods.~   "
128788|NCT01369719|"~     Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral~     iron chelators reduce iron overload in transfusion dependent patients. The aim of this study~     is to compare the efficacy and safety of osveral and desferal in transfusional iron overload~     patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.~   "
128663|NCT01371357|"~     A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia~     with the effects of GAA expected to be dose-dependent. Due to the fact that~     hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and~     neurodegenerative diseases, different dietary agents were used in the past for the treatment~     of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or~     folic acid. In the context of GAA loading the question arises whether intake of betaine,~     choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in~     healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take~     part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects~     will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and~     washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2~     (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and~     TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure~     assessed every second week throughout the study. Plasma B-vitamins and blood and urine~     metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along~     with adverse-effects indicators assessed every second week throughout the study. Selected~     body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to~     monitor the effects of experimental treatments on body hydration and protein synthesis. This~     research will test the hypothesis that a combination of GAA with homocysteine lowering~     nutrients attenuates the elevation of T-hcy, and will further display the size-effect of~     each additive used.~   "
128664|NCT01371344|"~     The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and~     effective Modigraf® is (Part A) and to see how safe and effective it is to change your~     child's medication from Modigraf® to Prograf® (Part B).~   "
128665|NCT01371331|"~     The purpose of this study is to find out how much of Modigraf is absorbed and used in the~     body and how fast it leaves the body (Pharmacokinetics). The results will then help to~     decide how much Modigraf in future can be given safely to children and young people~     following transplantation.~   "
128666|NCT01371318|"~     The purpose of this study is to determine whether using the OWEMR as part of the standard of~     care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the~     relationship between glycemic control and the rate of amputation secondary to chronic foot~     ulcers in Type II Diabetes.~   "
128667|NCT01371305|"~     The primary objective of this study is to evaluate the safety and tolerability of~     subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized~     monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as~     STX-100) in participants with IPF. The Secondary objectives are to estimate the~     pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple,~     escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of~     BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated~     from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.~   "
128668|NCT01371292|"~     The purpose of this Randomized Controlled Tria (RCT) is to evaluate the effects of a~     transformational teaching intervention in comparison to 'standard educational practices'~     within school-based physical education classes (within three Canadian provinces; British~     Columbia, Ontario and Nova Scotia) across 5 months.~   "
128669|NCT01371279|"~     This is a 2- component, single center study, witch aims to evaluate the efficacy of~     multisite intracardiac echocardiography (mICE) imaging of left atrial appendage (LAA) and in~     detecting thrombus located in LAA as compared to transesophageal echocardiography (TEE). The~     study group will consist of patients eligible for atrial fibrillation (AF) ablation~     procedure (Component I) or cardioversion (Component II).~      First component will enroll 100 patients; these patients will undergo clinically indicated~     TEE & cardiac catheterization procedures with ICE(AF ablation). Second component will enroll~     15-20 patients with AF or atrial flutter in whom a thrombus in LAA was detected by TEE prior~     to electrical cardioversion. The ICE probe will be located in multiple positions in the~     right atrium (RA), coronary sinus (CS), pulmonary artery (PA), right ventricular outflow~     tract (RVOT) and esophagus. This will enable the investigators to compare sensitivity and~     specificity of mICE and TEE.~      This study will examine two hypotheses in AF patients undergoing invasive cardiac~     procedures:~      Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of LAA from multiple~     positions (RA,CS,PA,RVOT and esophagus ). This will be evaluated during the component I of~     the study.~      Hypothesis 2: That ICE can identify low risk patients, CHADS Score < 2,0 in whom immediate~     cardioversion during the procedure is as safe as based on conventional strategy.~   "
128670|NCT01371266|"~     Honey has been used as a sweetener for centuries. Recent data indicate that honey~     consumption may have beneficial effects upon glucose intolerance, a health issue currently~     affecting 57 million Americans of every age and ethnicity. In order to evaluate the glycemic~     effect of honey, the investigators will carry out a human trial assessing biomarkers of~     blood glucose responses, insulin sensitivity, oxidative stress, and inflammatory markers.~     Our primary objective is to determine the glycemic effects of honey in comparison to sucrose~     and high fructose corn syrup (HFCS). The investigators hypothesize that honey will promote~     improved glucose tolerance and insulin sensitivity compared to both sucrose and high~     fructose corn syrup in normal glycemic and glucose intolerant adults.~   "
128671|NCT01371253|"~     On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in~     Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization~     is required. The cost of these admissions vary according to the type of injury with hip~     fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total~     average cost of a severe hip fracture in the Danish healthcare system resulting in nursing~     home placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year~     {{288 Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who~     sustain a hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the~     outcome of falling in the elderly population is therefore not only associated with severe~     human but also economical consequences. Hence, it is essential to refine, develop and think~     out of the box when future intervention programs are designed and employed in the elderly~     community.~      One such out of the box intervention could be balance training with a Nintendo Wii Fit~     board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is~     a new generation of computer game which uses 3D tracking of the participants' motion and~     gestures. This means that the user interacts in and controls elements of the 3D gaming world~     with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it~     detects the body sway and center of pressure (COP) of the participant and displays it onto a~     TV screen in different balance sceneries. A virtual character on the TV then reacts~     according to the user's movement and gesture (ex. skiing down a ski slope passing thru~     gates). This enables the user to perform tasks that, they may not be able to execute safely~     or at all in real-world situations. Interestingly in this context a study by Sihvonen et al~     from 2004 showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D~     and with a poor graphical display. Further, the Sihvonen-study showed that 2D biofeedback~     intervention of only 4 weeks proved successful in terms of improved postural balance,~     physical activity and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods~     when promoting physical activity in the elderly population has been limited by lack of~     motivation or poor compliance (REFS), which possibly has prevented the elderly from reaching~     a maximum rehabilitation potential(REFS). Furthermore, in the follow-up period after these~     traditional intervention studies, it has been documented how difficult it is for the elderly~     to sustain the same training volume on themselves (REFS).~      Virtual reality systems like the Nintendo Wii Fit have been developed specifically for~     rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and~     lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality~     platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L.~     2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion,~     speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these~     systems have not become commercially available possible due to a very high cost {{294~     Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to~     be constructed from scratch making the hole process and implication very complicated {{306~     Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost~     ready-to-use Wii Fit platform could be a possible research direction to explore. At the~     moment few studies have been conducted using the Nintendo Wii console. Among the few some~     have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports~     (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and~     boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the~     Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294~     Deutsch,J.E. 2008; }}.~      To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii~     Fit balance training in seniors (+65 years). The main purpose of the study is to investigate~     the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors~     (+65 years of age) have a significant effect on postural balance and muscle strength.~   "
128672|NCT01371240|"~     Accurate preoperative tumor detection and staging are fundamental for treating patients with~     pancreatic adenocarcinoma. Patients with unresectable tumors can benefit from being spared~     an extensive operation associated with substantial morbidity and mortality, cost, and pain.~     On the other hand, patients with localized disease, which is amenable to surgical removal,~     have the option of operation. Therefore, accurate staging of pancreatic cancer requires the~     detection of the tumor, and evaluation of its size, its relationship to major~     peri-pancreatic vascular structures and portal venous system, locoregional lymph nodes, and~     distant metastases. Multiple imaging techniques have been used to evaluate the pancreas.~     Although, at this point, no consensus exists as to the best staging algorithm, multidetector~     (MD) computed tomogrophy (CT) and Magnetic resonance imaging (MRI) provide sufficient~     information for the management of most patients.~      Patients with a tumor larger than 3 cm are characterized as non-surgical. CT sensitivity in~     detecting small pancreatic tumors of less than 2 cm is low. Multiple methods have been~     suggested to increase the sensitivity of CT. The sensitivity of CT increases with using~     multidetector CT which now has an accuracy rate of about 95-97% for initial detection and~     approximating that of 100% for staging.~      Secretin (a natural hormone produced by the duodenal mucosal cells) is known to increase~     blood flow to the pancreas. The principal use of secretin in imaging today is in exocrine~     function of the pancreas or morphological evaluation of the pancreatic duct under ultrasound~     or MRI. Theoretically, pancreatic contrast enhancement should also increase after secretin~     administration. This would imply that tumor conspicuity might also be increased if contrast~     enhancement of the normal pancreas increases. Secretin CT has been advocated by other~     centers to improve depiction of the ampulla and periampullary/duodenal diseases and to~     improve contrast enhancement. O'Connell et al, used secretin in patients suspected or with~     known pancreatic mass and concluded that administration of intravenous secretin leads to~     greater enhancement of the pancreas with greater tumor conspicuity, than imaging without~     secretin.~      MRI of the pancreas has undergone a major change because it can provide noninvasive images~     of the pancreatic ducts and the parenchyma. MR cholangiopancreatography (MRCP) enables~     detection of anatomic variants such as pancreas divisum. Although contrast material-enhanced~     CT is still considered the gold standard in acute pancreatitis and for the detection of~     calcifications in chronic pancreatitis, MR imaging and secretin-enhanced MRCP are useful in~     evaluating pseudocysts and pancreatic disruption.~      The role of MR is still debated in pancreatic neoplasms except the cystic lesions where MR~     imaging provides critical information regarding the lesion's content and a possible~     communication with the pancreatic ducts. Although some articles have shown that MRI was~     equivalent to CT in diagnosis and staging, others have shown the opposite. Nishiharu et al.~     found comparable tumor detection but a benefit with CT, notably for peripancreatic and~     vascular invasion. Comparing CT, echoendoscopy, and MRI, Soriano et al. demonstrated that CT~     showed the highest level of precision in primary tumor staging, local-regional staging,~     vascular invasion, distant metastases, Tumor, node, metastasis (TNM) staging, and tumor~     resectability. MRI retains its originality in imaging the parenchyma, the pancreatic and~     biliary ducts, and vascular structures; however, in many institutions, CT remains the~     reference imaging choice for diagnosing and staging pancreatic cancer. Other than CT's~     advantages for the tumor, its excellent spatial resolution also provides detailed~     reconstructions in all planes and arterial mapping and therefore makes it possible to search~     for surgical contraindications such as celiac trunk stenosis. MRI is still used today as a~     second-intention tool when there is doubt or when CT and echoendoscopy are not sufficiently~     conclusive; it is not currently recommended to use MRI in first-intention diagnosis of~     pancreatic cancer.~      The aim of this pilot study is to determine whether the administration of intravenous~     secretin before contrast-enhanced CT and MRI improves pancreatic enhancement and pancreatic~     tumor conspicuity and to evaluate which technique is more appropriate for pancreatic tumor~     detection, staging and evaluation of resectability.~   "
128673|NCT01371227|"~     The purpose of this study is to evaluate tolerability of the combination therapy of JNS002~     and bortezomib in Japanese bortezomib-naive patients with multiple myeloma who have ever~     received at least 1 line of chemotherapy.~   "
128674|NCT01371214|"~     The primary goal of this study is to perform a 36-week pilot study with a cross-over design~     to study the safety and efficacy of a novel integrative exercise program called PLIÉ~     (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and~     Western exercise traditions and is specifically designed to target the muscles and movements~     needed to help individuals with mild-to-moderate dementia maintain physical function and~     independence.~   "
129505|NCT01360294|"~     The aim of this study is to develop a patient reported outcome tool specific to small~     airways disease, which assesses symptoms and signs of small airways disease and may help in~     addition to FEF50% to discriminate between asthmatic patients with and without small airways~     disease.~   "
128677|NCT01371175|"~     The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and~     recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.~      Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled~     at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment~     of up to 10% (approximately 10 additional volunteers) will be permitted in the study.~   "
128678|NCT01371162|"~     This 2-part, randomized, double-blind, placebo-controlled study will assess the safety,~     pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with~     hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending~     doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).~   "
128679|NCT01371149|"~     To evaluate a novel advanced physiological monitoring system to improve nocturnal~     non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD),~     Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS)~     patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn,~     will improve ventilatory failure, quality of life and reduce length of admission during~     initiation of therapy. We aim to incorporate this technology into routine clinical practice.~   "
128680|NCT01371136|"~     Although a significant amount of work has been done to validate simulators as viable systems~     to teach technical skills outside the operating room, the next necessary step is to~     integrate simulator training into a comprehensive curriculum. The purpose of this study is~     to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal~     surgery. This curriculum will include training on a virtual reality simulator, cognitive~     training and cadaver lab training. The investigators will assess the effectiveness of the~     curriculum by conducting a randomized single blinded controlled trial. The investigators~     will be comparing the technical performance of curricular trained and non-trained residents~     in the operating room, during a procedure on a patient. The investigators hypothesize that~     surgical residents who participate in the curriculum will have superior technical~     proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery~     compared to conventionally trained residents.~   "
128681|NCT01371123|"~     The purpose of this study is to determine whether children on long-term parenteral nutrition~     (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender~     matched) that have never received parenteral nutrition.~   "
128682|NCT01371110|"~     Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a~     leading cause of worldwide disability that presents a significant public health problem.~     Treatment options are limited and many OCD patients fail to respond completely or quickly to~     standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who~     fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and~     behavioral therapy, have few additional treatment options aside from deep brain stimulation.~     Therefore, despite advances in current pharmacological and behavioral treatments, and the~     utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved~     and that targeting these systems may increase treatment efficacy. Despite little evidence~     for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic~     dysregulation may contribute to the development and progression of the disorder. Also,~     preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine),~     particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The~     NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single~     intravenous (IV) dose in depressed patients. Therefore, the objective of the current study~     is to investigate the safety and efficacy of a single dose of IV ketamine in~     treatment-resistant OCD.~   "
128683|NCT01371097|"~     The aim of the study is to evaluate the effect of progressive resistance strength training~     (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional~     training would improve the rehabilitation and increase the level of activity of daily~     living.~   "
128684|NCT01371084|"~     The primary aim of this pilot study is to test the efficacy of a worksite intervention for~     reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g.,~     measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary,~     overweight, full-time working adults as compared to a waitlist control. A secondary aim will~     be to test pedal time at work as a measure of compliance with the intervention.~   "
128685|NCT01371071|"~     A majority of patients with multiple sclerosis initially presents with a single~     demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to~     as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop~     multiple sclerosis but in those patients who do, irreversible damage of the central nervous~     system, e.g. axonal damage, is already detectable in that early stage of disease. Early~     initiation of immunomodulatory therapy is crucial for patients with clinically isolated~     syndrome who are at high risk for the development of multiple sclerosis. Vice versa~     identification of low risk patients could help to avoid an unnecessary therapy. In this~     prospective observational study we want to follow up patients with CIS and early multiple~     sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in~     order to identify risk factors for relapses, prognostic factors and therapy response~     markers.~   "
128686|NCT01371058|"~     Thrombotic event is one of the most serious complications of coronary artery disease, which~     often result in myocardial infarction and even death. Even according to the standard~     guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic~     events, in high-risk patients, the proportion is higher, this phenomenon is called~     anti-platelet drug resistance in clinical practice~      The aim of this multicenter prospective, randomized, controlled study is to observed~     policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after~     Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and~     short-term prognosis to find new ways to the prevention of platelet aggregation .~   "
128699|NCT01370889|"~     This pilot phase I trial studies resveratrol in postmenopausal women with high body mass~     index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of~     resveratrol may keep cancer from forming. Studying samples of blood and urine in the~     laboratory from postmenopausal women who are taking resveratrol may help doctors learn more~     about the effects of resveratrol on biomarkers.~   "
128687|NCT01371045|"~     The purpose of this study is to test the effect of long-acting somatostatin analog~     medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in~     comparison to healthy controls who are not receiving the medication in order to see whether~     or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance~     Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH~     responses in non-acromegaly subjects taking somatostatin analog treatment, the relative~     contribution of the medication and the underlying disease state can be analyzed.~   "
128688|NCT01371032|"~     The purpose of this study is to compare:~      the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy~     during tracheal intubation to the VideoMiller device (the standard pediatric blade with a~     camera attached, giving indirect view of the vocal cords in the screen). This intubation~     device is used to place the tube in the trachea to keep the patient breathing during the~     surgery procedure.~      The anesthesiologist obtains a better view of the vocal cords looking at the screen provided~     by the VideoMiller.~   "
128689|NCT01371019|"~     The purpose of this study is to to collect and store blood samples that will be utilized to~     develop a multimarker test to predict preterm delivery.~   "
128690|NCT01371006|"~     Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when~     administered together.~      To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe~     , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.~   "
128691|NCT01370993|"~     The purpose of this study is to develop the hypoxemia prediction model during fiberoptic~     bronchoscopy under MAC(monitored anesthesia care) anesthesia.~   "
128692|NCT01370980|"~     The purpose of this study is to implement a support interdisciplinary program(oncologists,~     pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral~     oncology treatments. The aim is to ensure continuity of care between~     professionals,effectiveness of treatment and patient safety.~   "
128693|NCT01370967|"~     The purpose of this study is to assess stool consistency, in combination with additional~     health-related parameters including gastrointestinal tolerance and health-related quality of~     life, in a large sample of Chinese infants. We will also assess the timing of, frequency,~     and reasons for changes in the choice of formula or method of feeding among infants in this~     sample, as well as incidence of common infant illness and associated healthcare usage.~     Anthropometric measures and the frequency and duration of physician- and parent-reported~     gastrointestinal and other adverse events will be evaluated.~   "
128694|NCT01370954|"~     This study will be an observational study in which patients who have been prescribed~     CerefolinNAC® are invited to participate in surveys regarding their experiences with~     CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional~     requirements of individuals under treatment for early memory loss with particular emphasis~     for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or~     hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12~     deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to~     increase the understanding of the role of CerefolinNAC® in managing proper neuronal function~     in the brain, provide patients with personalized education and support, and contribute to~     the overall understanding of the needs and concerns of patients being treated for early~     memory loss.~   "
128695|NCT01370941|"~     An adequate calcium intake is important for bone turnover and the risk of developing~     osteoporosis. Yet many studies have documented that supplementation with calcium tablets are~     often associated with a poor compliance, therefore it is important to explore ways to better~     calcium influx.~      Calcium consumed through dairy products must first be cleaved from the molecules which it is~     bound to before it can be absorbed. Chymosin is an enzyme which cleaves the protein binding~     between some amino acids in κ-casein. The reaction occurs after ingestion of milk and causes~     a process whereby the time the milk is staying gastrointestinal tract is extended, this can~     lead to enhanced uptake of calcium.~      When the body's calcium balance is in equilibrium excretion in urine (24 h) in roughly the~     size of the intake, whereby a measurement of circadian urine excretion of calcium can~     determine the amount of calcium absorbed from the intestine.~      The investigators want to clarify whether the addition of chymosin to milk increases calcium~     absorption. Secondary to explore issues of significance for this effect, including vitamin D~     status and amount of daily calcium intake and whether a change in calcium absorption has~     immediate effects on bone turnover (measured as plasma osteocalcin, bone specific alkaline~     phosphatase (BSAP), and the renal excretion of cross-linked N-terminal telopeptide of type 1~     collagen (NTx/Cr) ratio) and on the parathyroid function (measured as PTH). Finally we will~     explore relations between bone mineral density (BMD) and the measured parameters (in terms~     of P-PTH, P-25OHD, P-1,25(OH)2D, P-osteocalcin, P-BSAP, and U-NTx/Cr).~   "
128696|NCT01370928|"~     The purpose of this study is to compare the performance of a new prototype colonoscope with~     a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with~     a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the~     prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the~     patient. Both colonoscopes are manufactured by the same company.~   "
128697|NCT01370915|"~     Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in~     postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was~     to investigate the efficacy and safety of pregabalin for reducing postoperative pain in~     patients after septoplasty. Persons who scheduled for elective septoplasty under general~     anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice)~     or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain~     (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24~     hours postoperatively.~   "
128698|NCT01370902|"~     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the~     safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial~     drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and~     repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.~   "
128700|NCT01370876|"~     To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with~     recurrent or metastatic head and neck cancer and to assess the safety profile of these~     treatment regimen.~   "
128701|NCT01370863|"~     The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters~     of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal~     Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump~     inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability~     will be evaluated.~   "
128702|NCT01370850|"~     To perform a clinical validation study of RTVue features in volunteers with various ocular~     pathology or no ocular pathology.~   "
128703|NCT01370837|"~     Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in~     arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's~     disease can also be a consequence of polyneuropathy. Patients with Charcot's disease~     suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to~     foot fractures. After these fractures have healed, the shape of the foot can be dramatically~     altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves~     are important in regulating the inflammatory response. This study aims to investigate~     whether the inflammatory response is different in patients with polyneuropathy with and~     without a history of Charcot's disease.~   "
128704|NCT01370824|"~     Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most~     frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its~     incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the~     suspected lesion, in order to determine the subtype of BCC. There are three different~     histological subtypes of BCC, from least to most aggressive: superficial, nodular and~     aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin~     is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes~     according to the Dutch guidelines. Recent developments of non-invasive therapies for~     superficial BCC might be the first choice of treatment in the future. These non-invasive~     treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better~     cosmetic results than SE and are therefore also used in the Maastricht University Medical~     Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes~     grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin~     respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic~     surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the~     subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment.~     A potential better or equal way to determine the BCC subtype might be the clinical~     diagnosis. To our knowledge, there is no literature about the diagnostic value of the~     clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to~     confirm the hypothesis that the clinical diagnosis is as good as, or even better than the~     histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this~     case, patients don't have to undergo an extra procedure, diagnostic route is shortened.~      - Primary objective: to establish the observed agreement of clinical diagnosis compared to~     histological diagnosis by to determine the most aggressive subtype of BCC~      - Secondary objectives: inter-observer and intra-observer variability of dermatologists and~     pathologists to determine subtype BCC.~   "
128705|NCT01370811|"~     The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral~     solution is effective in reducing saliva secretion in patients suffering from Parkinson's~     Disease with excessive salivation.~   "
128706|NCT01370798|"~     Hypospadias is a congenital abnormality of the penis that is caused by incomplete~     development of the anterior urethra. This pathology is one of the most common genital~     anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male~     births and is increasing regularly. The hypospadias surgeries present a high risk of post~     operative complications requiring re-interventions.~      A great part of the post operative complications is related to imperfect healing issues. If~     androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact~     positively on the skin healing process. This point leads to the hypothesis that local~     transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the~     number of skin healing post-operative defects.~      The objective of the study is to assess the effect of oestrogen (applied once daily for 2~     months prior to surgery) on the post-operative complications.~   "
128707|NCT01370772|"~     Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase~     monotherapy before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in~     previously untreated symptomatic B-cell chronic lymphocytic leukemia CLL.~      A Study from the Goelams GCFLLCMW intergroup~   "
128708|NCT01370759|"~     The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.~   "
128709|NCT01370746|"~     In this study, doctors will observe how and when pediatric patients who have received a~     solid organ transplant take their prescribed medication, and determining if there are~     reasons that keep these patients from taking all of their medicine.~   "
128710|NCT01370733|"~     This study is designed to evaluate the safety and efficacy of synchronized transcranial~     magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects~     with Major Depressive Disorder. This is a multicenter study in which subjects will be~     randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks~     of double-blind treatment may be eligible to receive up to four weeks of open label sTMS~     therapy or antidepressant medications during the follow-up phase of the study. Follow-up~     evaluation visits will be conducted during those four weeks, with the frequency of the~     visits determined by the treatment choice during that timeframe.~   "
128711|NCT01370720|"~     Despite the pathophysiology of IBS remains largely unsettled, several mechanisms have been~     proposed to explain symptom generation. These include psychosocial factors, altered~     gastrointestinal motor function and altered perception of visceral stimuli because of~     chronic low-grade inflammation and increased nociceptive mediator release by inflammatory~     cells, particularly mast cells.~      The aim of this pilot study is to provide evidence of:~        1. intestinal mast cell (MC) infiltration and activation in IBS patients;~        2. down-modulation of MC activation by the oral administration of the association of~          palmitoylethanolamide (PEA) and polydatin in IBS patients.~   "
128712|NCT01370707|"~     The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.~   "
128713|NCT01370694|"~     This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in~     combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single~     agent, for participants with B-lymphocyte antigen cluster of differentiation 20~     (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study~     hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a~     single agent.~   "
128714|NCT01370681|"~     The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose~     combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered~     to healthy subjects.~   "
128762|NCT01370057|"~     The purpose of this study is to compare the risk of curve progression in Adolescent~     Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.~   "
128715|NCT01370668|"~     Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of~     the population. Recent research point at the relevance and persistence of cognitive~     dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment~     has been classically associated with schizophrenia and not bipolar disorder. Current~     findings suggest that some intervention is needed in order to improve not only affective~     symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive~     remediation techniques to improve cognitive impairment and the functional outcome. There is~     no previous research on the efficacy of cognitive remediation programs on bipolar disorder.~   "
128716|NCT01370655|"~     This study is being done to evaluate the antihypertensive efficacy and tolerability of~     MK-7145 in participants with mild-to-moderate hypertension.~   "
128717|NCT01370642|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin~     (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants~     with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the~     percentage of participants achieving sustained virologic response 24 weeks after completion~     of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the~     percentage of participants achieving SVR24 in the control arm.~   "
128718|NCT01370629|"~     This non-interventional prospective study is a post-authorization safety study (PASS) of~     vernakalant conducted to collect information about normal conditions of use and appropriate~     dosing, and to quantify possible medically significant risks associated with the use of~     vernakalant in real-world clinical practice.~   "
128719|NCT01370616|"~     This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of~     moderate to severe diabetic foot infections. The primary hypothesis was that treatment with~     ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in~     achieving clinical improvement or cure.~   "
128720|NCT01370603|"~     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg~     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin~     40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.~   "
128721|NCT01370590|"~     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg~     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin~     20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.~   "
128722|NCT01370577|"~     The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly~   "
128723|NCT01370564|"~     This chronic, prospective, non-randomized feasibility study is designed to evaluate the~     Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic~     Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter~     Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers~     Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF)~     Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac~     filling pressures from the Chronicle device to provide timely medication adjustments~     (diuretics) to subjects.~   "
128724|NCT01370551|"~     The purpose of this study is to assess the longterm safety and efficacy of the vaginal~     application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on~     atrophic vaginitis in postmenopausal breast cancer patients who have been treated with~     aromatase inhibitors.~   "
128725|NCT01370538|"~     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment~     of frequent heartburn~   "
128726|NCT01370525|"~     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment~     of frequent heartburn~   "
128727|NCT01370512|"~     The hypothesis is that pyridostigmine will improve the safety factor of ganglionic neural~     transmission, while Droxidopa will replete the postganglionic neuron of norepinephrine (NE).~     This combination should result in enhanced orthostatic release of NE. The investigators have~     already demonstrated that pyridostigmine does not raise supine blood pressure.~   "
128728|NCT01370499|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin~     Reuptake Inhibitors (SSRI) for up to approximately 1 year in patients with Major Depressive~     Disorder (MDD) who were partial responders to their SSRI treatment.~   "
128729|NCT01370486|"~     Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome,~     various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences.~     The tonic seizure occur mostly at night.~      The hypothesis is that the melatonin could have a positive effect in that syndrome, by~     reducing the epileptic activity (assessed in the polysomnographic record by counting the~     number of interictal and ictal discharges) and stabilizing the structure of sleep.~      The study is double blind, randomised, cross-over designed.~   "
128730|NCT01370473|"~     The purpose of this study is to create an institutional and population-based registry of~     Hyponatremia with a prospective survey based on epidemiological data, risk factors,~     diagnosis, prognosis, treatment, monitoring and survival.~      This study will also describe the occurrence of hyponatremia in the population of HIBA in~     the Central Hospital, as well as the characteristics of clinical presentation, evolution and~     predisposing factors of hyponatremia.~   "
128731|NCT01370460|"~     This study aims to assess postoperative blood loss and transfusion rates in total knee~     replacement after one-time administration of topical tranexamic acid.~   "
128732|NCT01370447|"~     This study evaluates the safety and efficacy of EPI-743 in patients with severe~     mitochondrial respiratory chain diseases who are considered to be within 90 days of~     end-of-life care.~   "
128733|NCT01370434|"~     Based the proven efficacy and the ability to induce rapid response of various combinations~     of bortezomib including PAD combination in refractory and newly diagnosed patients with~     Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD~     combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the~     feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of~     PAD.~   "
130973|NCT01341093|"~     The purpose of this study is to elaborate an educative program that includes telephone~     follow-up and assess its impact on the perceived health status of patients submitted to~     percutaneous coronary intervention.~   "
128734|NCT01370421|"~     This is an observational study (not a treatment study) of pain and physical functioning~     after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after~     surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement~     surgery, do not have a serious heart condition or certain other medical conditions, and are~     not taking certain types of medications. The study includes evaluation of peoples' pain,~     physical functioning, medication use, and physiological responses to sensory stimuli such as~     heat and cold.~   "
128735|NCT01370408|"~     In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30~     minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.~     On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be~     administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen~     is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be~     administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given~     orally for 2 days following chemotherapy.~   "
128736|NCT01370395|"~     Elderly patients are often admitted to hospital because of chest pain that is atypical for~     angina pectoris. In case of inconclusive electrocardiograms, determination of troponin is~     important for the diagnosis of an acute coronary syndrome. A highly sensitive assay for~     troponin T has recently been developed, permitting measurements of concentrations that are~     lower by a factor 10 than those measureable with conventional assays. In patients with~     stable coronary artery disease these concentrations were significantly associated with the~     incidence of cardiovascular death and heart failure but not with myocardial infarction.~     Copeptin, a novel biomarker of endogenous stress, may improve the diagnostic performance of~     troponin for an acute coronary syndrome in elderly patients. Other biomarkers such as~     MR-pro-adrenomedullin and endothelin-1 could improve both the diagnostic and prognostic~     assessment of the physician in these patients.~   "
128737|NCT01370382|"~     The planned cohort study shall clarify whether the use of biomarkers leads to improved~     diagnostic assessment of elderly patients. The study will evaluate the clinical value of~     biomarkers (highly sensitive Troponin T, Troponin T of the 4th generation) in elderly~     patients. These biomarkers are analyzed together with the symptoms and other parameters~     collected at admission. The diagnosis of myocardial infarction could be made earlier and~     more accurately with the help of biomarkers, in particular the highly sensitive troponin T.~   "
128738|NCT01370369|"~     This is an open-label study of a single and repeated application of three dose levels of~     topical testosterone in hypogonadal males with morning serum testosterone concentrations <~     297 ng/dL.~   "
128739|NCT01370356|"~     This study will determine whether varenicline is safe and helps people to quit smoking~     through reduction when they are not willing/able to make an abrupt quit attempt.~   "
128740|NCT01370343|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability of a single dose of PF-04991532 in healthy adult subjects with and without~     co-administration of cyclosporine.~   "
128741|NCT01370330|"~     This is a compassionate use protocol to allow patients with advanced neuroblastoma~     palliative access to 131I-metaiodobenzylguanidine (131I-MIBG).~   "
128742|NCT01370317|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple~     dose treatment with MK-1029 in adults with mild to moderate persistent asthma.~   "
128743|NCT01370304|"~     The purpose of this study is to treat participants with a diagnosis of depressive disorder~     to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and~     venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal~     medication) and to rTMS only. fMRI will be performed to determine if treatment response is~     related to changes in fMRI, and use it to investigate the respondence to the treatments.~   "
128744|NCT01370291|"~     The aim of the study is to evaluate the effects of repetitive transcranial magnetic~     stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings~   "
128745|NCT01370278|"~     The goal of this clinical research study is to compare the effects of sodium bicarbonate to~     normal saline when used for clearing mucus blockage in patients with airway stents.~   "
128746|NCT01370265|"~     Blockage of the heart arteries (coronary artery disease) can lead to angina (chest pain),~     heart attacks, heart failure, and/or death. Positron emission tomography (PET) stress~     myocardial perfusion imaging (MPI) is a powerful tool to help identify blockages in the~     coronary arteries. During the PET MPI test, a drug is given to mimic the effects of exercise~     on the heart. The study was done to measure blood flow to the heart using two similar drugs~     approved to mimic the effects of exercise on the heart in people during a heart stress test.~     The first drug, called adenosine, has been approved for this use for several decades. The~     second drug, called regadenoson, was approved in 2008. The investigators were looking at~     whether the increase in blood flow to the heart with the newer drug (regadenoson) was~     similar to the increase in blood flow with the older drug (adenosine). This information is~     important for the use of these drugs in patients and for interpreting the blood flow values.~   "
128747|NCT01370252|"~     Post-operative pain will be measured using a pain diary for one week post-surgery. The~     purpose is to test the assumption that the arthroscopic technique leads to less~     post-operative pain and results in shorter hospital stays when compared to the open~     technique. It is believed that the arthroscopic technique will result in minimal pain when~     compared to the open technique, allowing this procedure to be performed as day surgery.~   "
128748|NCT01370239|"~     The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to~     be safe in previous studies and has also been indicated as potential intervention in breast~     cancer. The study of this new agent in advanced breast cancer may contribute to the~     development of new strategies for patients that progressed after hormonal treatment.~   "
128749|NCT01370226|"~     The aims of the study are to develop and refine tailored motivational brief interventions~     that are parallel in structure but have varied delivery modalities (computer vs. therapist)~     for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled~     trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent~     alcohol consumption and alcohol consequences, including alcohol-related injury, mental and~     physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.~   "
128750|NCT01370213|"~     This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative~     haploidentical transplantation for the treatment of high-risk acute myeloid diseases.~     Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early~     stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free~     neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28~     patients will be enrolled for a total of 43 patients. Patients will be followed for disease~     response for 2 years.~   "
128751|NCT01370200|"~     The investigators want to compare the efficacy of plasma exchange treatment with using two~     different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.~      The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as~     anticoagulant during the plasma exchange procedure.~   "
128752|NCT01370187|"~     The aim of the current study is to evaluate the effect of Montelukast in treatment of acute~     bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age~     in Bandar Abbas Children' hospital.~   "
128753|NCT01370174|"~     Falls and their consequences are among the major problems in the medical care of older~     individuals. The long-term goal of this research is to establish the efficacy of a~     scientifically grounded and mechanism-based therapeutic intervention for improving balance~     function and preventing falls in older people. When human balance is challenged, protective~     stepping is a vital strategy for preventing a fall during activities of daily life. Many~     older people at risk for falls have particular difficulties with successfully stepping~     sideways as a protective response to loss of balance in the lateral direction. We propose~     that age-related declines in lateral balance function through impaired protective stepping~     that precipitates falls, result from neuromechanical (NM) limitations in hip~     abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that~     these functional and NM impairments are reversible with combined high intensity induced step~     training (IST) and muscle strengthening.~   "
128754|NCT01370161|"~     The purpose of this study is to determine whether early use of transjugular intrahepatic~     portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to~     prolong the survival in cirrhotic patients with high risk acute variceal bleeding.~   "
128755|NCT01370148|"~     The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour~     continuous infusion of conivaptan in subjects with severe liver impairment compared to~     subjects with normal liver function.~   "
128756|NCT01370135|"~     Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris~     surface induced by an increased level of vascular endothelial growth factor (VEGF). In~     progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits~     aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is~     often difficult to control and frequently results in loss of vision.~      The aim of this study is to analyze the short- and long-term outcome after adjuvant~     intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and~     to analyze the role of ranibizumab within a holistic treatment regime.~   "
128757|NCT01370122|"~     Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and~     risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are~     not known. The investigators plan to perform an observational study including survivors of~     gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be~     mailed to survivors to generate prevalence rates and risk factors for PFD in women with a~     history of a gynecologic cancer diagnosis.~   "
128758|NCT01370109|"~     Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell~     carcinoma and have significant off-target effects with cardiac toxicity and resultant~     ventricular cardiac dysfunction being a major concern. However, the mechanisms of these~     effects in humans remains poorly defined, as are the clinical methods to risk stratify and~     identify patients who will ultimately suffer from cardiac dysfunction. The goal of this~     multi-center study is to characterize the cardiovascular measures of cardiac function; 2)~     comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers~     reflective of the pathophysiologic alterations. Through this work, the investigators will~     translate our basic understanding of sunitinib cardiotoxicity to humans and identify early~     predictors of sunitinib cardiotoxicity.~   "
128759|NCT01370096|"~     To diagnose pulmonary hypertension, children have a cardiac catheterization to check the~     blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure~     in their lungs. The right ventricle of the heart has to do more work to pump against this~     higher pressure. The investigators do not know the best medicine(s) to help children with~     pulmonary hypertension when their right ventricles fail. The purpose of the study is to look~     at the effects of two different medicines on the blood pressure in the lungs of a child with~     pulmonary hypertension. The investigators hope to then be able to choose the best medicine~     for children with pulmonary hypertension and right ventricular failure.~      The first medicine is called vasopressin. It is a hormone that your body makes on its own.~     The investigators will be giving it through an intravenous infusion. The investigators think~     that vasopressin works differently in different parts of your body. The investigators are~     looking to see the different effects that vasopressin has in the lungs compared to the rest~     of the body.~      The second medicine is called prostacyclin and is something that your body also makes by~     itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary~     hypertension as it decreases pressure in the blood vessels. In the catheterization~     laboratory, patients breathe in this medicine to measure specific changes in the blood~     pressure in their lungs.~   "
128760|NCT01370083|"~     People with swallowing impairment experience particular difficulty swallowing thin liquids~     safely; the fast flow of liquids makes them difficult to control. The tongue plays a~     critical role in containing liquids in the mouth, channeling the direction of their flow~     towards the pharynx (throat) and controlling their flow along that channel. The~     investigators are engaged in a program of research to better understand tongue function in~     swallowing, particularly with respect to controlling the flow of liquids. In this study the~     investigators will compare two different tongue-pressure resistance training protocols, to~     determine whether a protocol that emphasizes strength-and-accuracy or one that emphasizes~     pressure timing work better for improving liquid flow control in swallowing.~   "
128761|NCT01370070|"~     To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic~     nasopharyngeal carcinoma (NPC)~   "
128763|NCT01370044|"~     The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in~     patients with febrile seizures compared to a placebo-inhalation.~      Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure~     can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation~     via a low pressure can with a breathing mask in a home-setting or on the way (mobility), the~     quality of life of the parents and children using the low pressure can with a breathing mask~     in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.~   "
128764|NCT01370031|"~     The purpose of this study is to evaluate, at steady-state, the systemic exposure and the~     lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after~     inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the~     Volumatic™ spacer device without or with charcoal block.~   "
128765|NCT01370018|"~     For more than 20 years, alpha-1-Proteinase Inhibitor therapy (Zemaira®) has been the~     standard treatment for patients who have too little alpha-1-Proteinase Inhibitor in blood.~     Adult patients with this condition eventually develop emphysema. Most HIV-1 patients who~     have low viral load also have too little alpha-1-Proteinase Inhibitor in blood. Recent~     strong evidence shows that the number of CD4 cells in blood goes up when alpha-1-Proteinase~     Inhibitor goes up. Patients were asked to participate in a pilot study to see whether the~     use of Zemaira® (alpha-1-Proteinase Inhibitor) would increase blood levels of~     alpha-1-Proteinase Inhibitor and consequently increase CD4 cells.~   "
128766|NCT01370005|"~     This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type~     2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and~     macrovascular complications, assessment of both glucose and blood pressure lowering effects~     of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly~     relevant, new information for the use of BI 10773~   "
128767|NCT01369992|"~     Cancers are among the most frequent leading causes of death in Taiwan, and many of them show~     their respective unique epidemiological and pathophysiological features in Taiwanese~     population. One of the distinguishing features of cancers includes their potential to~     metastasize outside the primary tumor. Pleural cavity and peritoneum are two of the most~     frequent sites of metastases when serosal surfaces are involved. The prognoses of such~     patients are extremely poor with a median survival of months. The understandings of cancer~     biology of tumor metastasis demand more in-depth studies at the molecular and cell levels.~     Studies based on cell culture are excellent approaches for this purpose as the cell culture~     provides a relevant and renewable model for studying the pathological and molecular changes~     underlying human malignant tumors.~   "
128768|NCT01369979|"~     The investigators wish to determine the lumped constant (LC), which is a correction factor~     necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those~     of regular glucose in patients with cirrhosis and healthy subjects.~      Working hypothesis~        -  LC for FDG in liver tissue is not significantly different from unity in healthy~          subjects~        -  LC for FDG in liver disease is significantly different from LC in healthy liver~        -  Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver~          disease and healthy subjects.~   "
128769|NCT01369966|"~     Background:~      - Smoking is associated with serious health risks. People who have mental illness are more~     likely to smoke. Researchers are studying the brain circuits linked with smoking and~     nicotine craving. This study will look at whether a specific brain circuit can explain the~     high rate of smoking in people with schizophrenia.~      Objectives:~      - To study brain activity in smokers and nonsmokers with and without schizophrenia, as well~     as their family members.~      Eligibility:~        -  Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18~          and 62 years of age in one of the following groups:~        -  Have been diagnosed with schizophrenia.~        -  Family members of those with schizophrenia.~        -  Healthy adults with no history of severe mental illness or brain trauma.~        -  Family members of the healthy adults.~      Design:~        -  People in the study will be screened with a physical exam, medical history,~          questionnaires, and blood tests.~        -  They will have up to three visits: the screening visit and two study visits (each given~          1 year apart).~        -  At the first study visit, those taking part will be trained in the tests they will do~          during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.~        -  After the first study visit, current smokers will receive phone calls from the study~          researchers every other month for 1 year. They will be asked about their smoking~          habits.~        -  At the second study visit, current smokers and some nonsmokers will have another MRI~          scan and the same tests as before.~        -  Current smokers will receive a final phone call 1 year after the second study visit.~          They will be asked to give information about their smoking habits.~   "
128770|NCT01369953|"~     Since 2007, the cost of sequencing a diploid human genome has fallen dramatically, from~     approximately $70 million to $20,000. As affordable sequencing platforms become more widely~     available, the advancement of biomedical science will draw increasingly on whole genome~     sequencing research requiring large cohorts of diverse populations. Key policy, ethical and~     legal implications of these developments will need to be understood in order to promote the~     efficacy and effectiveness of genomic research going forward.~      An overall aim of this project is to obtain feedback on the informed consent process from~     some of the earliest particpants in studies using whole genome sequencing. A more specific~     goal is to characterize the salient personal and public references accessed by participants~     around the time of the informed consent process. By highlighting trends in participants~     views about study participation around the time of the initial informed consent process, we~     aim to advance the development of an ethically and socially relevant vocabulary with which~     to negotiate future terms of use for personal sequence data in genomic research.~      Participants will be asked to complete a one-time, semi-structured telephone interview~     lasting approximately 45 minutes in the period 2-8 weeks following their initial informed~     consent session at the NIH. They will be recruited from two NIH protocols employing whole~     genome sequencing for distinct purposes. They The ClinSeqTM Study is a large-scale medical~     sequencing project investigating the causal role of genetics in cardiovascular disease~     enrolling both symptomatic and healthy individuals. The Whole Genome Medical Sequencing for~     Gene Discovery Study (WGMS) enrolls children and adults for full sequencing with the aim of~     discovering the genetic etiology of rare conditions.~   "
128771|NCT01369940|"~     Background:~      -Normal growth and development of twins are important for a healthy pregnancy and the~     long-term health of the children. This study will look at how twins grow and develop inside~     the womb. This knowledge may reduce and/or prevent pregnancy and newborn health problems in~     the future.~      Objective:~      -To describe how twins grow.~      To describe how identical (from the same egg) and fraternal (from different eggs) twins~     grow.~        -  To compare growth patterns between twin and single pregnancies.~        -  To find out how many babies have growth problems and why they have them.~      Eligibility:~      -Women from nine U.S. clinical centers who are in the first three months of a twin~     pregnancy.~      Design:~        -  Participants will answer questions about personal characteristics (age, education,~          race). They will also answer questions about pregnancy history, health behavior, and~          their environment. This will take about 30 minutes. They will also fill out a~          questionnaire about physical activity, and mood and depression. An ultrasound will be~          done to check on the babies measurements.~        -  Participants will return for six visits during their pregnancy. Each follow-up will~          include an ultrasound and a test to measure the length of the cervix. We will ask~          questions about health and any events or symptoms since the visit before. We will also~          take body measurements.~        -  A nutrition questionnaire will be completed at the first visit and at follow-up visits~          2 and 5.~        -  Blood will be drawn at the beginning of the study, at three follow-up visits, and just~          before delivery.~        -  When the babies are born, they will have placenta and cord blood samples, measurements,~          and swabs from the inside of the mouth.~   "
128772|NCT01369927|"~     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a~     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide~     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the~     LPS (O-SPC). The O-SPC is covalently bound to the recombinant non-toxic exoprotein B of~     Clostridium difficile.~      The objective of this phase of the study is to determine if this vaccine is safe and can~     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective~     is to determine if this vaccine can elicit higher levels of IgG antibody than the previous~     experimental vaccines made with the full length O-SP, shown to be >70% efficacious in~     greater than or equal to3 year old children, to induce type-specific immunity to shigellosis~     in younger children.~      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be~     vaccinated on a random basis with one i.m. injection of 10 or 25 micrograms of the~     investigational conjugate vaccine. Local and systemic reactions will be observed at 30~     minutes, and the volunteers will be instructed to take their temperature and examine the~     injection site for redness and swelling and fill out a questionnaire at 6, hours and daily~     for 7 days after vaccination. The volunteers will visit the clinic at 24 or 48 hours~     following the injection and any time they request it. The study will commence with 5~     volunteers injected with the 10ug dose to be followed, if no severe adverse reactions occur,~     by 5 volunteers injected with the 25ug dose. If a severe adverse reaction occurs on 1 of the~     5 volunteers in either group, 5 more will be injected with that dose. If there are no severe~     adverse reactions the study will proceed. If there is one more severe reaction the study~     will be halted and re-evaluated by the IRB and the FDA.~      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and~     compared to those elicited by our previous S. sonnei conjugate vaccines.~      There is a body of evidence that a critical level of serum IgG antibody to the O-specific~     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other~     Shigella:~        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious~          explanation for this is that maternally-derived serum IgG provides this immunity;~        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,~          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric~          bacteria;~        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age~          when the maternally-derived serum anti-O-SP has waned and the naturally-derived~          antibodies have not yet appeared;~        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against~          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis~          showed significantly lower serum IgG responses to the homologous LPS than those did~          not.The high antibody level induced by the conjugate vaccine indicates the positive~          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;~        5. Following Phase 1 and Phase 2 studies that showed safety and age-related~          immunogenicity, a double-blinded randomized and vaccine-controlled Phase 3 evaluation~          of S. sonnei and S. flexneri type 2a O-specific polysaccharide (O-SP) protein~          conjugates was conducted among 1-4 year-olds in Israel.~      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old~     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no~     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum~     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels~     declined rapidly several months after the last injection. Our interpretation is that the~     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP~     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of~     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by~     our S. sonnei O-SP.~      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound~     by their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages~     between the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and~     aminooxy linkers bound to the carrier. The coupling reaction was carried out at a neutral pH~     and room temperature. The carrier protein was a mutant non-toxic Clostridium difficile~     exotoxin B. IgG antibody levels induced in young outbred mice by this new S. sonnei O-SPC~     conjugate were significantly higher than those elicited by the O-SP conjugates.~   "
128773|NCT01369914|"~     Background:~        -  Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell~          disorders, and immune disorders. Stem cells from a donor s blood are used to replace~          the recipient s stem cells in the bone marrow. The recipient s bone marrow can then~          produce new blood cells. Some of these new cells involved in the immune system are like~          the donor s cells. Sometimes immune cells from the SCT attack the recipient s normal~          tissues, including the eyes. This type of immune attack is called graft-versus-host~          disease, or GVHD.~        -  The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation.~          When it is severe and if it does not respond well to treatment, ocular GVHD may also~          cause vision loss.~      Objective:~      - To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had~     stem cell transplantation.~      Eligibility:~        -  Participants must be at least 18 years of age.~        -  They must be taking part in a study at the National Cancer Institute (NCI) or the~          National Heart, Lung and Blood Institute (NHLBI).~        -  They must have a SCT scheduled within the next 30 days.~      Design:~        -  The study lasts for 1 year and includes six visits to the National Eye Institute.~          (There is an optional visit about 1 month before your SCT.) When possible, visits for~          this study will be scheduled so that they can be done on the same day as your visits~          for the NCI or NHLBI protocol that you are taking part in.~        -  At each visit, participants will have a medical exam and an eye history will be taken.~          They will have an eye exam and a test to measure the ability to make tears. Those in~          the study will also have tear fluid collected for analysis in a lab. Tear fluid~          collection is a painless process. Blood will be drawn during certain visits if it has~          not already been collected by the transplant team.~   "
128774|NCT01369901|"~     Background:~      -Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People~     with SBMA often have weakness throughout the body, including the muscles they use for~     swallowing, breathing, and speaking. We do not know if exercise helps or harms people with~     SBMA.~      Objective:~      -To see if a 12-week program of either functional exercise or stretching exercises will~     improve strength, function, or quality of life in people with SBMA~      Eligibility:~        -  Participants will be men 18 years of age or older who have genetic confirmation of~          SBMA.~        -  They must be able to walk at least 50 feet with or without an assistive device such as~          a cane or a walker and stand for 10 minutes without using an assistive device.~        -  They must have access to a computer with an Internet connection.~      Design:~        -  At the first visit to NIH (2 days), participants will have a medical history taken and~          undergo a physical exam. They will also have blood tests and an EKG, and complete~          questionnaires about mood, health, and exercise. Tests of muscle strength, balance, and~          endurance will also be done.~        -  Participants who qualify for the study will receive instruction about either~          strengthening or stretching exercises. They will do these exercises at home one to~          three times a week for 12 weeks.~        -  They will wear a small activity monitor while they exercise and record their exercise~          in a diary.~        -  At the end of 12 weeks, participants will return to the NIH for 2 days. They will~          undergo the same tests as they had on the first visit.~        -  Participants will receive follow-up phone calls and e-mails during the study and for 4~          weeks after the last visit.~   "
128775|NCT01369888|"~     Background:~      - Researchers have developed an experimental cancer treatment called cell therapy. White~     blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab,~     and then given back to the patient. Interleukin-15, given to the patient after the cells~     (now called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the~     cells to grow and boosts the immune system. This process changes your normal cells into~     cells that are able to recognize your tumor has been studied in the lab. These cells can~     destroy tumor cells in the test tube, but scientists want to see if they work inside the~     body.~      Objectives:~      -To test the effectiveness of lymphocytes drawn from tumor cells combined with~     interleukin-15 in treating metastatic melanoma.~      Eligibility:~        -  Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma.~        -  They will have heart and lung function tests, lab tests, and imaging procedures.~        -  Patients may not have conditions such as active systemic infections, blood clotting~          disorders, or other active major medical illnesses.~        -  Patients may not be pregnant or nursing.~   "
128787|NCT01369732|"~     During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and~     reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the~     lower extremities and successive reperfusion results in injury to remote organs, including~     kidneys. So, there has been considerable interest in the development of therapeutic~     strategies aimed at attenuating IR injury. One such group of agents that are attracting~     interest due to their potential protective effects on vascular endothelium is the~     erythropoietin.~      However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not~     been fully clarified. Therefore, the purpose of this study is to determine whether the~     prophylactic administration of erythropoietin reduce the incidence of acute kidney injury~     (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The~     investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min~     before the commencement of ischemia. The differences between the control and study groups~     are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.~   "
128776|NCT01369875|"~     Background:~      - Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor~     tissue. The cells are modified to help them kill tumor cells, then given back to the person~     with cancer. By giving these cells to patients, researchers hope to improve the current~     treatments available for patients with melanoma that has not responded to standard~     therapies. The TIL will be given after treatments that will suppress the immune system. This~     makes it easier for the TIL to attack the cancer cells. The TIL will also be given with~     aldesleukin (IL-2), which is designed to help keep the TIL cells alive in the body.~      Objectives:~      - To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes~     to treat melanoma that has not responded to other treatments.~      Eligibility:~      - Individuals at least 18 years of age who have metastatic melanoma that has not responded~     to other treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have blood tests and imaging studies.~        -  A piece of tumor will be collected and white blood cells will be separated to make the~          TIL for the treatment.~        -  Participants will take drugs to suppress the immune system for 7 days before the start~          of treatment.~        -  Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8~          hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks~          after treatment. They will be monitored with frequent blood tests and other studies.~        -  After leaving the hospital, participants will have regular followup visits every 1 to 4~          months for the first year. Then they will return for followup every 3 to 4 months, as~          directed by the study researchers.~   "
128777|NCT01369862|"~     The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose~     of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza~     virus infection. It is also performed to assess immunogenicity and pharmacokinetics~     (shedding).~   "
128778|NCT01369849|"~     This phase I/II trial studies the side effects and best dose of v-akt murine thymoma viral~     oncogene homolog 1 (Akt) inhibitor MK2206 when given together with bendamustine~     hydrochloride and rituximab and to see how well they work in treating patients with~     refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells~     and help kill them or carry cancer-killing substances to them. Giving Akt inhibitor MK2206~     with bendamustine hydrochloride and rituximab may be an effective treatment for relapsed~     chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
128779|NCT01369836|"~     The purpose of this study is the following:~        -  To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered~          tafamidis in Japanese and Western healthy volunteers at single dose.~        -  To compare Japanese and Western PK profiles.~        -  Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a~          validated ex vivo assay.~   "
128780|NCT01369823|"~     The purpose of this study is to examine whether pump treatment combined with the use of~     continuous glucose monitoring system is a mena to normalize glycaemic control.~   "
128781|NCT01369810|"~     To investigate how a switch from fixed combination treatment (ICS and LABA) to other~     treatments influence asthma or COPD treatment failure~   "
128782|NCT01369797|"~     Background :~      The evolving concept of frailty was born in the United States under the term of  frail~     elderly . It allows describing geriatrics situations, dominated by the weakness or the~     functional instability of aged person, illustrating situations at risk. It is about an~     effective concept, especially in the field of the prevention where it determines strategies~     of specific care. The ageing, changing according to individuals, is characterized by a~     decrease of the physiological reserves leading to a precarious balance and to a~     destabilization.~      Epidemiological studies show a very uneven distribution of three categories of old persons~     according to their health status. Every year, approximately, 12 % of the independent~     population of 75 years of age and older and living at home, lose their autonomy for one of~     the activities of the daily life and turn into frailty.~      Identifying frailty of old subjects is interesting in order to apply preventive and specific~     care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA)~     is the gold standard to detect frailty in this population. The beneficial effects of the GGA~     during the hospitalization have been recognized in international literature.~      The ageing heterogeneousness complexity and the high time-consuming character of GGA led to~     a difficult approach for the nurses or family practioners in taking care of old persons at~     home.~      To balance these difficulties and to optimize prevention of dependence in the elderly, an~     experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis~     of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital~     University of Limoges. It is an innovative organizational structure because, for the first~     time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary~     gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an~     occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA~     to detect the risks of loss of autonomy and to propose a coordination of preventive actions.~      Purpose :~      UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This~     action is led in partnership with all the professionals working around old persons.~      The randomized study endpoint is to evaluate elderly from 75 years of age and older at home~     and to select two homogeneous groups: reference and  specific intervention .~   "
128783|NCT01369784|"~     The purpose of this study is to evaluate the prognostic value of clinical and biological~     factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.~   "
128784|NCT01369771|"~     The objective of this study is to investigate corneal confocal microscopic findings, ocular~     signs and symptoms in patients on treatment with the preserved prostaglandin analogue~     latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free~     prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using~     latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion~     criteria including the specified ocular symptoms and signs, will switch from latanoprost~     0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve~     (12) months.~   "
128785|NCT01369758|"~     The objective of this study is to demonstrate the safety and effectiveness of community~     gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the~     MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.~   "
128786|NCT01369745|"~     Thus study will test an experimental drug called Z-102 (combination of prednisolone and~     dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.~   "
129506|NCT01360281|"~     The purpose of this study is to compare the efficiency of neuromuscular electrical~     stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and~     on recovering motor function of patients with knee osteoarthritis.~   "
128789|NCT01369706|"~     Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are~     restrained in daily life by possible electromagnetic interference (EMI). Case reports~     suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively~     used as part of security screening processes in e.g. airport controls.~      The objective was to determine the safety of screening procedures for ferrous materials with~     regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.~   "
128790|NCT01369693|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
128791|NCT01369680|"~     The study is a maximum tolerated dose finding study for oral, chronic, daily administration~     of oral ketamine (by mouth) in children with long-term daily pain.~   "
128792|NCT01369667|"~     The purpose of this study is to determine whether vitamin D supplementation is effective in~     the prevention of relapse in Crohn's disease.~   "
128793|NCT01369654|"~     The investigators propose to conduct formative research to gain an understanding of~     patients' needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO)~     decision making, and to develop and pilot test a BSO Decision Support Guide, in preparation~     for a randomized, controlled trial of the effect of this decision aid on decision quality~     and use of BSO. The proposed study will consist of 3 phases. In phase 1, the investigators~     plan to conduct focus groups among women who have had a hysterectomy with or without~     bilateral salpingo-oophorectomy (BSO) to gain an understanding of what they understood about~     BSO and its possible outcomes at the time of their hysterectomy and what they would have~     liked to have known, the extent and manner in which they were included in decision making~     regarding BSO, and how they feel about the decision now. The investigators also will collect~     qualitative data from women who are scheduled for hysterectomy and currently facing the~     decision whether or not to undergo elective BSO. In phase 2, the investigators plan to~     create a BSO Decision Support Guide using information obtained from the literature, from our~     formative research, and the experience of providers who have counseled women about this~     choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide~     among women scheduled to undergo hysterectomy for benign conditions to assess its usefulness~     and usability for patients and their providers and to prepare for a randomized study of its~     impact on decision quality and use of BSO. 62 women who are scheduled to undergo~     hysterectomy for a non-cancerous uterine condition will participate in the pilot study.~     These women will participate in a baseline interview, during which they will be provided~     access to the BSO Decision Support Guide, and 2 follow up telephone interviews (one as they~     are making their final BSO decision and a second after they have undergone and recovered~     from their hysterectomy (with or without BSO). Data will be used to generate the final~     version of the Decision Support Guide, to finalize evaluation measures for future studies of~     the effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge,~     BSO use, decision satisfaction and decisional conflict.~   "
128794|NCT01369641|"~     This is a pilot, randomized, self-controlled study of the effects of intratympanic sodium~     thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy.~     Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution~     which is used routinely as an otic solution delivered to the middle ear space.~      The hypothesis of this study is that local administration of sodium thiosulfate (STS) will~     result in improved hearing compared to ears not receiving the study drug in patients~     receiving systemic cisplatin therapy.~   "
128795|NCT01369628|"~     The sponsor electively terminated the study because the risk mitigation measures, deemed~     necessary after an unforeseen safety event, could not be effectively implemented within this~     protocol while maintaining study timelines within a reasonable time frame.~   "
128796|NCT01369615|"~     The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride~     (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17~     years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring~     opioid therapy who completed the 4 -week treatment period in OTR3001.~   "
128797|NCT01369602|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.~   "
128798|NCT01369589|"~     The primary objective of this clinical study is to determine the impact of P-552 oral rinse~     on salivary volume after administration of a single dose of P-552and versus vehicle rinse.~     Changes in oral mucosal wetness will be assessed via collection of salivary output and via~     measurement of oral wetness using the Periotron 8000 instrument.~   "
128799|NCT01369576|"~     The clinical population targeted will be newly diagnosed patients with polysomnographically~     diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.~     Outpatients who are also judged to be capable to follow the study procedures (consent,~     timelines, visits, questionnaires) and who do not have any concurrent disease that in the~     view of the investigator will interfere with participation in the trial to completion will~     be included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent~     trial of eszopiclone. This size is expected to be able to discern an important difference of~     80 minutes per night. In the current clinical population newly prescribed CPAP at Mount~     Sinai Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD~     2:59) hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in~     usage per night, including entirely non-adherent patients who do not use treatment at all as~     'zero hour' users, would require randomization of 264 patients (132 per group).~      Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be~     improved by initial prescription of a common hypnotic, zopiclone. To answer this question we~     intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician~     (ABSM or by a respirologist with extensive sleep medicine experience) with supportive~     polysomnography results who are willing to initiate long-term CPAP treatment.~   "
128800|NCT01369563|"~     To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied~     as a nasal spray for four weeks. The main outcome will be the improvement on global and~     individual typical and associated symptoms of intermittent or persistent rhinitis.~   "
128801|NCT01369550|"~     The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic~     acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3~     fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women.~   "
128856|NCT01368835|"~     The clinical trial evaluates the clinical outcomes associated with the non-invasive~     treatment to obtain lift and tightening of the cheek tissue and improve jawline definition~     and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in~     a focused manner below the surface of the skin~   "
128802|NCT01369537|"~     Two hundred million adults worldwide have major surgery every year. A million of these~     patients will have an obvious stroke after their surgery. Another 10 million patients may~     have silent strokes. Although silent strokes are not diagnosed immediately, they are~     likely to reduce patients' short-term memory, concentration, and ability to function at~     home. However, the investigators do not know how common silent strokes are after noncardiac~     surgery, nor the extent to which they affect brain function.~      The investigators will first perform a pilot trial to determine the feasibility of the~     larger study that will provide the definitive answer to this question. Participating~     patients will be assessed by questionnaire before and after surgery, and will have a~     magnetic resonance imaging (MRI) study of the brain after the surgery to look for silent~     strokes. Combining the results of the MRI and the questionnaires will allow us to determine~     the frequency of silent strokes after non-cardiac surgery, and their effect on brain~     function. The NeuroVISION Pilot Study will determine the feasibility of a large study to~     examine the frequency and the impact of silent stroke in patients who undergo noncardiac~     surgery.~   "
128803|NCT01369524|"~     Although the investigators take many measurements to monitor the fluid state of the~     patients, it is not known exactly whether the fluid has real effect on the organ perfusion.~     The main focus of fluid is to improve the organ perfusion. Recent research has focused on~     the investigation of sublingual microcirculatory alterations.~   "
128804|NCT01369511|"~     The primary objective of this study is to test the hypothesis that appendicular lean body~     mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older~     participants undergoing elective total hip arthroplasty (eTHA).~   "
128805|NCT01369498|"~     This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow~     fibrosis either alone or in combination with ruxolitinib in participants with Primary~     myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia~     Myelofibrosis (ET/PV MF).~      The study is designed as a two stage trial. In the stage 1, patients will be randomized into~     two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, patients on~     ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.~   "
128806|NCT01369485|"~     The purpose of this study is to evaluate the change from baseline between the active and~     sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).~   "
128807|NCT01369472|"~     This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg,~     64mg, 128mg in healthy male volunteers.~   "
128808|NCT01369459|"~     The goal of this project is to develop and test a brief protocol designed to systematically~     integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD)~     into behavioral treatment services for adolescent substance users with co-morbid ADHD in~     everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and~     fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services~     utilization, medication acceptance and compliance, and satisfaction with treatment services.~   "
128809|NCT01369446|"~     The purpose of this study is to demonstrate that the Eeva System may be used to identify~     embryos on Day 2 that are most likely to form blastocysts.~   "
128810|NCT01369433|"~     Open-label, multi-center, multi-national rollover study to allow continued access to~     tivozanib for subjects who have participated in other tivozanib (monotherapy or combination)~     protocols. Eligible subjects will continue to receive tivozanib at the same dose and~     schedule as per the original (parent) protocol. The length of time that a subject must be on~     the parent protocol before rolling over to this protocol will be dictated by the (original)~     parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse~     events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning~     of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be~     recorded. CT scans to assess disease will be performed at the end of even-numbered cycles~     (Cycle 2, Cycle 4, etc).~   "
128811|NCT01369420|"~     The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low~     Energy Direct Current (LEDC) System when used to treat unresectable pancreatic~     adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including~     serious adverse events, laboratory data, physician exam findings, and vital signs.~   "
128812|NCT01369407|"~     REVIVAL will establish a prospective, observational, multicenter patient cohort in~     ambulatory patients with chronic, advanced, systolic heart failure that will provide a~     greater understanding of their clinical trajectory (rates of hospitalizations,~     transplantation, MCSD use and death), and of how baseline clinical risk measures are related~     to prognosis.~   "
128813|NCT01369394|"~     The goal of this study is to determine whether a computer-based intervention that delivers~     individually-tailored educational messages about the MMR vaccine increases MMR~     vaccine-hesitant parents' intentions to have their children vaccinated.~   "
128814|NCT01369381|"~     Current methods for endotracheal intubation in the presence of cervical spine (c-spine)~     instability are not evidence-based. This is so because the relationships between the forces~     applied during intubation (by the laryngoscope) and the resulting c-spine movement have not~     yet been quantitatively characterized. As a result, with the current level of knowledge, it~     is not known, and it is not possible to predict, which types of c-spine instability have the~     greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it~     impossible to know which intubation devices and techniques are likely to be safest in the~     presence of c-spine instability.~      To address this critical lack of knowledge, the overarching purpose of the proposed research~     is to: 1) quantitatively relate c-spine movement that results from the forces applied to the~     peri-airway tissues during intubation (force-motion relationships), and 2) use these data to~     develop a mathematical model of the c-spine that will predict which types of c-spine~     instability result in the greatest amount of abnormal c-spine motion and associated spinal~     cord compression during intubation.~      This clinical study will utilize laryngoscope blades that are instrumented with a high~     resolution pressure mapping system to make high-resolution measurements of the forces and~     pressures of intubation while making simultaneous measurements of c-spine motion. In this~     study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope~     and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the~     investigators, will introduce forces of differing magnitudes and distributions to~     peri-airway tissues. The Airtraq does not require a direct line of sight to visualize the~     vocal cords, and among the various new alternative laryngoscopes it is the only one that has~     been shown to result in 30-50% less cervical motion than a conventional (Macintosh)~     laryngoscope. Accordingly, we hypothesize 1) 30-50% less force will be applied with the~     Airtraq laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less~     c-spine motion will occur with the Airtraq. By studying (intubating) each subject twice, any~     differences in the c-spine force-motion relationships between devices will be due to the~     devices themselves. By studying each subject twice, we can account for (and eliminate)~     differences among study subjects in c-spine biomechanical properties.~   "
128869|NCT01368666|"~     The primary objective of this clinical investigation is to assess the safety and~     effectiveness of the Perceval S valve at 12 months after implantation when used to replace a~     diseased or dysfunctional aortic valve or aortic valve prosthesis.~   "
128815|NCT01369368|"~     Patients with relapse of acute leukemia often only receive supportive therapy. Our~     hypothesis is that a combination therapy can stabilize the disease for patients with early~     relapse after allogeneic stem cell transplantation. The investigators will combine~     5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from~     day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15~     of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte~     infusions on day 10 is allowed from the second cycle.~   "
128816|NCT01369355|"~     The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance~     regimens of ustekinumab administered subcutaneously to patients with moderately to severely~     active Crohn's disease who responded to treatment with intravenous ustekinumab in studies~     CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.~   "
128817|NCT01369342|"~     This study (UNITI-2) will compare the effects (both positive and negative) of an initial~     treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely~     active Crohn's disease.~   "
128818|NCT01369329|"~     This study (UNITI-1) will compare the effects (both positive and negative) of an initial~     treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely~     active Crohn's disease who have either failed or could not tolerate at least one~     TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or~     certolizumab pegol).~   "
128819|NCT01369316|"~     That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at~     least as safe but more effective than conventional EMR for injection assisted EMR of large~     laterally spreading tumour and sessile polyps of the colon.~   "
128820|NCT01369303|"~     The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics~     (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing~     regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex~     acts.~   "
128821|NCT01369290|"~     Current methods of choosing treatment for major depressive disorder (MDD) are inefficient.~     The Strategic Treatment to Achieve Remission of Depression (STAR*D) Trial revealed that only~     about 1/3 of patients treated with antidepressant drugs will go into remission with the~     first medication chosen. We hypothesize that pattern recognition software using Machine~     Learning methods can accurately predict response to a variety of antidepressant medications~     (ADM) or cognitive behavior therapy (CBT) after training using pre-treatment demographic,~     clinical, laboratory or electroencephalographic (EEG) data. These algorithms might assist~     the clinician to chose, for any given patient, an antidepressant treatment option with~     greater probability of favourable response than is achievable using current best practise~     methods.~   "
128822|NCT01369277|"~     This study is to investigate the safety, tolerability and pharmacokinetics of single~     ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is~     to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532~     in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western~     healthy subjects.~   "
128823|NCT01369264|"~     The proposed study is designed to determine whether small changes in the positioning of a~     transcranial magnetic stimulation coil over the frontal parts of the brain cause different~     patterns of brain activation measured by electroencephalography (EEG) and quantitative EEG~     (QEEG).~   "
128824|NCT01369251|"~     The purpose of this study is to determinate whether in newborns just cleaning the umbilical~     stump when changing diapers (with water and soap if necessary)is effective in preventing~     local cord infections and not delaying cord separation as just as cord care alcohol, usually~     applied in our hospital and suggested to parents at dismission.~   "
128825|NCT01369238|"~     1. Purpose of study~             1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom~               Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale~             2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom~               Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and~               EQ-5D.~        2. Interventions & Groups~             1. group 1: Bee-Venom Acupuncture Therapy~             2. group 2: zaltoprofen~             3. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen~   "
128826|NCT01369225|"~     This is a study to evaluate the safety and tolerability of multiple doses of AAB-003~     (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete~     study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each~     patient's participation will last approximately 52 weeks.~   "
128827|NCT01369212|"~     This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks~     followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir~     alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome~     will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained~     off-treatment response).~   "
128828|NCT01369199|"~     The investigators propose to evaluate the safety and efficacy of a short lead-in course (8~     weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40~     weeks. The investigators hypothesize that using a potent nucleos(t)ide analogue will provide~     a higher rate of loss of HBeAg loss and suppression of HBV DNA.~   "
128829|NCT01369186|"~     Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and~     pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel,~     ticagrelor)~   "
128830|NCT01369173|"~     The foods eaten daily are considered the dietary pattern of a culture or country. The~     dietary pattern of Mexico is different from that of the United States. To look at the~     effects of these patterns, participants in this study eat a Mexican menu for three and a~     half weeks and an American menu for the same length of time. At the beginning and end of~     each menu period participants provide blood and urine samples which we analyze to compare~     the effects of each diet. More info at www.ProyectoCOMIDAS.info~   "
128886|NCT01368445|"~     The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15%~     azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per~     nostril twice daily in patients with seasonal allergic rhinitis.~   "
128887|NCT01368432|"~     This research is being done to see if a drug called escitalopram (Lexapro) is helpful to~     people who are suffering from depression after traumatic brain injury (TBI).~   "
128831|NCT01369160|"~     The research proposed is a pilot study of pediatric and adolescent/young adult patients who~     have received the curative intervention (MSD-SCT), disease-modifying interventions (HU or~     CT) or SCC (control), with respect to three clinically important outcomes: quality-of-life~     (QOL), neurocognitive function, and reproductive potential. Comparable cohorts will be~     identified for each of the groups, drawing from patients treated by the SCD program of~     Children's Healthcare of Atlanta (CHOA). QOL measures and neuropsychiatric testing and will~     be administered. Reproductive endocrine function markers (laboratory studies and pubertal~     staging), will be collected and analyzed. A tracking system of such patients will also be~     developed, gathering available retrospective data and setting up a mechanism for collection~     of new data.~   "
128832|NCT01369147|"~     Protein and/or energy deficits are associated with increased rates of hospital infection,~     skeletal muscle weakness, impaired wound healing, and prolonged convalescence in ICU~     patients. To prevent or treat malnutrition, enteral nutrition (EN) and/or parenteral~     nutrition (PN) are routinely given worldwide to a significant proportion of ICU patients.~     Optimal caloric requirements in critically ill patients are unknown due to a lack of~     rigorous randomized clinical trials. The comparative efficacy of energy doses in critically~     ill patients is unknown and clinical recommendations are conflicting and controversial; this~     issue is the focus of our study.~      The investigators have designed this pilot, single-center Randomized Clinical Trial (RCT) to~     prospectively compare, for the first time, the clinical efficacy of different energy doses~     in ICU patients requiring PN due to intestinal failure/dysfunction. A total of 60 patients~     will be studied (20 per energy dose group) to generate critical preliminary data needed to~     inform subsequent appropriately powered Phase III multicenter trials.~      The primary aim of this study is to perform a controlled, double-blind, prospective,~     randomized, intent-to-treat Phase II clinical trial to test the efficacy of three specific~     energy doses [0.6, 1.0 and 1.3 x measured REE (resting energy expenditure), respectively],~     given for 28 consecutive days during the ICU and post-ICU course, on 28-day total~     hospital-acquired infections (primary endpoint), Blood Stream Infections ( BSI), and other~     important clinical outcomes in medical/surgical ICU patients requiring specialized~     parenteral ± enteral feeding. The investigators would also determine, in these subjects A)~     the impact of cumulative and mean daily 28-day energy deficits [energy intake-measured REE]~     on clinical outcome endpoints; and B) the practical utility of estimated REE determined by~     Harris-Benedict equation versus measured REE across different energy doses. The~     investigators would also like to determine the impact of administered energy dose and energy~     deficits on global metabolomic patterns over time and their association with key clinical~     outcomes.~      This study will allow us to generate needed data on the effect of energy dose and energy~     deficits on global metabolomic patterns over time that may be associated with key clinical~     outcomes in ICU patients. This exploratory research is also needed to develop new methods~     that evaluate the metabolic responses to nutrition support and their potential relationships~     to clinical outcomes.~   "
128833|NCT01369134|"~     Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel~     and dentin is as effective as a one-step etch and rinse approach.~   "
128834|NCT01369121|"~     This study is being conducted to evaluate the safety and tolerability of Xerecept® in~     children with central nervous system tumors and to identify appropriate doses of Xerecept®~     to be used in subsequent pediatric clinical trials.~   "
128835|NCT01369108|"~     Study hypothesis: a new, low polymerization stress flowable composite performs no~     differently to a conventional, highly filled composite filling material when used as a~     restorative in small cavities in back teeth.~      Study will evaluate the clinical performance of a low shrinking flowable composite filling~     material, compared with a conventional, highly filled composite restorative when used to~     permanently fill small cavities in molar and premolar teeth in adult patients.~   "
128836|NCT01369095|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared~     with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant~     depression (TRD).~   "
128837|NCT01369082|"~     The purpose of this study is to provide patients who have received at least one islet~     transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT)~     clinical trial with maintenance immunosuppressive medications and to collect information~     about the safety of the medications and islet function.~   "
128838|NCT01369069|"~     The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized,~     controlled clinical trial of 1400 patients that will include approximately 60 enrolling~     sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke~     patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result~     in improved 3 month outcome after stroke.~      Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and~     glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will~     include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites~     from all over the United States. The study will evaluate the safety and efficacy of targeted~     glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control~     therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The~     primary outcome will be functional outcome at 3 months as measured by the modified Rankin~     Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40~     mg/dL. Enrollment will occur over 3.5 - 4 years.~   "
128839|NCT01369056|"~     The general objective of this study is to evaluate HAART adherence in Estonia and the~     factors affecting adherence; and the impact of an individual adherence enhancement~     counselling and treatment monitoring model (Advanced Adherence, AdvAdh), compared to the~     regular counselling received by HAART patients.~   "
128840|NCT01369043|"~     Moderate exercise is thought to be one of the best known means to improve how insulin works~     in people. Taking vitamin C and vitamin E is also thought to have the same effect. This~     study is being done to see if taking vitamin C and vitamin E improves or hinders how insulin~     works when people do not exercise and when they do exercise.~   "
128841|NCT01369030|"~     This study will be an observational study in which patients who have been prescribed Deplin®~     are invited to participate in surveys regarding their experiences with Deplin®. The purpose~     of this study is to increase the understanding of the role of L-methylfolate among patients~     who are candidates for Deplin®, provide patients with personalized education and support,~     and contribute to the overall understanding of the needs and concerns of patients being~     treated for depression.~   "
128842|NCT01369017|"~     The investigators want to see if healthy people who are given 2 doses of a medication called~     anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then~     exposed to a form of air pollution, called Endotoxin, have less inflammation with the~     medication. Endotoxin is believed to be one of the causes of asthma attacks.~   "
128888|NCT01368419|"~     This study is to explore the clinical efficacy of continuous Endostar infusion combined with~     radiotherapy in esophageal cancer patients.~   "
128889|NCT01368406|"~     The aims of this study were to evaluate the efficacy of an intervention for weight gain~     management for patients from schizophrenia spectrum compared to treatment as usual (TAU),~     and to evaluate the effects of this program on metabolic profile, symptoms and quality of~     life.~   "
128843|NCT01369004|"~     The purpose of this research project is to assess the efficacy of a weight loss intervention~     for chronic disease prevention that focuses on daily self-weighing as the primary~     self-monitoring strategy compared to a delayed-intervention control group. While daily~     self-weighing has been shown to be effective for weight loss in observational research,~     there is limited experimental evidence testing this association and most is derived from~     intensive interventions that may overshadow the effects of self-weighing. To mitigate this,~     the investigators will examine whether daily self-weighing is effective for weight loss~     under self-directed conditions using a randomized-controlled design.~      The investigators will conduct a 6-month randomized trial in 88 overweight and obese adults~     to compare a daily self-weighing intervention to a delayed-intervention control group.~     Changes in weight, diet and physical activity, and psychosocial measures will be examined.~      Main Study Hypothesis: Participants in the group randomized to receive the daily~     self-weighing intervention will have greater percent weight loss at 6 months compared to~     those in the delayed control group.~      Secondary Hypothesis: Participants in the group receiving the daily self-weighing~     intervention will report greater engagement in diet and physical activity behaviors that~     produce caloric deficits, greater self-efficacy and motivation, and no differences in body~     satisfaction, disordered eating, or depressive symptoms compared to those in the control~     group.~   "
128844|NCT01368991|"~     Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic~     surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac~     surgery patients at high risk for sternal wound complications. The investigators have~     designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of~     kryptonite to conventional closure. The primary outcome will be quality of life. Secondary~     outcomes include sternal complications, pain, hospital length of stay, and respiratory~     function.~   "
128845|NCT01368978|"~     This study is a prospective, single-center, open label, randomized; two-arms cross over~     study.~      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin~     delivery into the blood when the insulin is infused using an insulin-infusion pump by~     controlled heating of the area surrounding the point of infusion.~   "
128846|NCT01368965|"~     This prospective, multi-center, single treatment clinical trial evaluates the clinical~     outcomes associated with non-invasive treatment to obtain lift and tightening of facial~     tissue and improve jawline definition in subjects with darker skin color utilizing the~     Ulthera® System to deliver focused ultrasound energy below the skin surface.~   "
128847|NCT01368952|"~     Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI)~     and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep~     Apnea.~   "
128848|NCT01368939|"~     This research protocol is designed to evaluate a novel imaging camera, only one of three of~     it's kind in existence, in the diagnosis of breast cancer. The Molecular Breast Imaging~     Camera (MBI) is a gamma camera that images accumulation of 99mTc-Sestamibi, a~     radiopharmaceutical with high affinity for tissues of high cellularity and mitochondrial~     content; a common characteristic of breast cancers.~      This camera represents a significant advancement over its predecessors as it has improved~     imaging geometry since it can be in direct contact with breast tissue and improved gamma~     photon detection capability through the use of cadmium zinc telluride (CZT) crystals (a~     semiconductor material) instead of NaI used in standard gamma cameras.~      This project involves imaging patients with a baseline population risk of breast cancer,~     referred for myocardial perfusion imaging (MPI). This is possible because 99mTc-sestamibi is~     also used to image myocardial tissue. After the MPI study is performed to standard clinical~     specifications, the patient is simply imaged with the MBI.~      The primary endpoint of this project is to assess acceptability of this imaging device by~     the patient through the use of a patient survey. Secondary endpoints are to correlate any~     findings on the MBI studies with standard breast imaging modalities including mammogram,~     ultrasound, and MRI. Image quality will be evaluated by the interpreting physicians. Also,~     in an effort to reduce radiation absorbed dose to the female breast, low injected dose~     images, obtained through post-processing by reframing acquired images, will be assessed for~     acceptable image quality and diagnostic accuracy.~   "
128849|NCT01368926|"~     This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the~     pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In~     Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either~     RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy~     Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523~     or placebo orally daily for 14 days.~   "
128850|NCT01368913|"~     Desmopressin in treatment of nocturnal enuresis (bedwetting).~   "
128851|NCT01368900|"~     The purpose of this prospective, multi-center, single treatment study is to evaluate the~     clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the~     eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of~     the skin.~   "
128852|NCT01368887|"~     The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product)~     in patients with scalp Psoroasis. The study is also intended to assess the safety of the~     product.~   "
128853|NCT01368874|"~     This prospective, multi-center, single treatment clinical trial evaluates the clinical~     outcomes associated with a non-invasive treatment to obtain lift and tightening of facial~     and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused~     manner below the surface of the skin.~   "
128854|NCT01368861|"~     The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's~     (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with~     sucrose, during routine immunizations at 2 and 4 month well child visits.~   "
128855|NCT01368848|"~     Despite recent advances in the treatment of NSCLC overall survival within these patients~     remains dismal and there is yet an unmet medical need for additional treatment options. In~     this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and~     bevacizumab) is tested to determine the objective response rate in patients with~     unresectable and advanced non-small cell lung cancer. This response rate will be compared~     with historical data.~   "
130974|NCT01341080|"~     The purpose of this study is to determine if varenicline is effective in improving gait and~     balance impairment in patients with Parkinson disease.~   "
128857|NCT01368822|"~     Several studies have shown that renal function in patients who have donated a kidney (but~     are otherwise healthy) remains stable and within normal limits. However, it is unclear how~     donor nephrectomy affects patient subsets with comorbidities, an issue that becomes relevant~     in the current environment where inclusion criteria are continuously becoming less stringent~     and more patients are being considered as potential donors.~      In the present study, the investigators plan to evaluate long-term renal function in obese~     patients who have donated a kidney as part of a living donor renal transplant procedure. The~     investigators have selected this group because it is at higher risk for developing~     obesity-related complications such as diabetes and hypertension that may impair renal~     function, it is rapidly becoming a major subgroup in the kidney donor population, and no~     studies have systematically followed obese patients after kidney donation. Establishment of~     an appropriate control group is of primary importance in studies examining long-term~     outcomes. The investigators will also evaluate a 2-kidney control group to allow us to~     compare the individual and interactive effects of obesity and kidney donation on long-term~     renal function. Study participants will complete a medical questionnaire, undergo blood~     pressure measurements, and provide blood and urine samples for analysis of various metabolic~     parameters. Some study participants will have ambulatory blood pressure monitoring performed~     which involves application of an automated blood pressure cuff for 24 hours. Some study~     participants will also undergo direct measurements of glomerular filtration rate (GFR) with~     iohexol.~      In the proposed research, the investigators hypothesize that obesity in kidney donors~     increases the likelihood of developing renal dysfunction and risk factors for cardiovascular~     disease (CVD) and may increase the likelihood even more than in healthy controls.~   "
128858|NCT01368809|"~     The purpose of this research is to evaluate the effectiveness of fentanyl for reducing~     coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway]~     device, maintenance period during surgery, and awakening [emergence] from general~     anesthesia) for ambulatory surgery procedures. Also to assess the effects of fentanyl on the~     postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel~     function [constipation], resumption of normal activities of daily living).~      Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because~     of its anesthetic-sparing effects and alleged ability to reduce coughing during~     instrumentation of the patient's airway.~   "
128859|NCT01368796|"~     Based on information from several years of looking at Influenza vaccination doctors know~     that:~        -  Older adults suffer the worst illness and most deaths caused by Influenza illness of~          all age groups.~        -  Older adults do not seem to get as good a level of protection as younger adults after~          getting the usual seasonal Influenza vaccine.~      Because of this information doctors wonder if one of the new seasonal Influenza vaccines is~     more effective or more acceptable.~      This study has been designed to answer some of these questions. On this study doctors will~     compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using~     several different testing methods (including the usual tests) and for acceptability.~   "
128860|NCT01368783|"~     Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in~     Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with~     tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to~     investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and~     Caucasian volunteers and compare the ethnic differences.~   "
128861|NCT01368770|"~     The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is~     lack of data which supports their use in the initial evaluation of patients who are~     asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use~     of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of~     asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events~     will result in less further non-invasive and invasive testing and result in reduced costs,~     without adversely affecting clinical outcomes in the short term.~   "
128862|NCT01368757|"~     In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide~     in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started~     once an optimal dose has been found. The primary endpoint will concern the efficacy of~     lenalidomide in patients with CMML according to the WHO diagnostic criteria.~   "
128863|NCT01368744|"~     The study will determine the sensitivity, specificity, negative predictive value and~     positive predictive value of the OSNA Breast Cancer System by comparing its performance to~     an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during~     standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.~   "
128864|NCT01368731|"~     The hypothesis of this study is that prophylactic coagulation therapy with coagulation~     forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal~     Resection (EMR) will reduce the rate of delayed bleeding when compared with current~     established standard EMR technique.~   "
128865|NCT01368718|"~     Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be~     induced or aggravated by underlying sleep disturbances. The relationship between sleep~     quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep~     quality on fatigue, a randomized controlled and cross-over trial with nasal continuous~     positive airway pressure (nCPAP) is carried out in patients who present with a primary~     complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index~     (AHI) >= 15 on polysomnography (PSG).~      The aim of this study is to address the issue of Continuous Positive Airway~     Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with~     obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness.~     The answer to this question may shed further light on the enigmatic relationship between~     sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure~     responsiveness regarding sleepiness and general health in the same target population.~     Zero-hypothesis: there is no effect.~   "
128866|NCT01368705|"~     The objective is to the amount of protein infants require after cardiopulmonary bypass~     surgery.~   "
128867|NCT01368692|"~     The purpose of this study is to determine whether the shoulder retraction by placing a~     saline bag between the scapula influences a success rate of subclavian vein catheterization.~   "
128868|NCT01368679|"~     This is a prospective multicenter observational study with 20 patients to evaluate the~     performance of SCITECH stent for treatment of AAA. Will be enrolled the patient~     demographics, laboratory tests, medical history, clinical evaluation, physical examination,~     adverse events.~      The benefits and risks of the study should be explained before any specific test or~     procedure of the study. The written consent must be obtained from the patient. No action~     specifies the study should be performed while the patient has not signed the form of~     consent.~   "
128870|NCT01368653|"~     This clinical trials tests whether a new treatment designed to help smokers prepare to quit~     smoking by practicing quitting several times helps more smokers quit and stay quit than~     standard treatment with nicotine patch and smoking cessation counseling. The practice~     quitting treatment being tested involves quitting for progressively longer periods of time~     tailored to individual patterns of smoking. This clinical trial will also test whether~     non-nicotine cigarettes can help smokers become smoke free after slipping during a stop~     smoking attempt.~   "
128871|NCT01368640|"~     Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM~     based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and~     measurement data of the BIA devices on the other hand. The equations are necessary to use~     the device as a Body Composition Analyzer with an acceptable accuracy level for clinical~     practice.~   "
128872|NCT01368627|"~     E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in~     the treatment of unselected, high risk patients having coronary Artery blockage in the real~     world clinical practice.~   "
128873|NCT01368614|"~     The purpose of this study is to evaluate the feasibility of using of the Average Volume~     Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP)~     and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed~     with Obesity Hypoventilation syndrome.~      The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will~     yield daytime gas exchange values which are equivalent or no worse when compared to using~     CPAP and bilevel PSV modes of ventilation in the OHS population.~   "
128874|NCT01368601|"~     This is a randomized placebo-controlled trial studying the effects of intraoperative~     continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer~     undergoing lobectomy.~   "
128875|NCT01368588|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation~     therapy may stop the adrenal glands from making androgens. Radiation therapy uses~     high-energy x-rays to kill tumor cells.~      PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation~     therapy in treating patients with prostate cancer.~   "
128876|NCT01368575|"~     The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate~     and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact~     on heart failure and progress of mitral regurgitation.~   "
128877|NCT01368562|"~     This is an open label compassionate use study of subcutaneously administered MNTX in~     subjects with advance medical illness and opioid-induced constipation. Eligible subjects~     were to initially receive a single dose of MNTX delivered SC. Subsequent dosing could have~     been adjusted upward to achieve a desired clinical response or lowered to alleviate drug~     related adverse events (AEs).~   "
128878|NCT01368549|"~     This study will be an observational study in which patients who have been prescribed Metanx®~     are invited to participate in surveys regarding their experiences with Metanx®. The purpose~     of this study is to increase the understanding of the role of Metanx® in managing diabetic~     neuropathy, provide patients with personalized education and support, and contribute to the~     overall understanding of the needs and concerns of patients being treated for diabetic~     neuropathy.~   "
128879|NCT01368536|"~     This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna~     and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and~     diabetes mellitus 2.~   "
128880|NCT01368523|"~     The purpose of this study is to provide patients with imatinib resistant/intolerant chronic~     myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been~     previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib~     (AMN107) in Poland until such time as the treatment with this drug is financed by the~     National Health Found in Poland (via 'therapeutic program') or for a period of 18 months,~     whichever comes first.~   "
128881|NCT01368510|"~     Even with the best available treatments for obsessive-compulsive disorder (OCD), most~     patients only partially recover and many patients do not respond at all. Such incomplete and~     inadequate response contributes to greater public health costs in terms of morbidity and~     patient care expenses. This study aims for a better understanding of abnormal brain~     chemistry in OCD and how it is affected by cognitive-behavioral therapy (CBT) in order to~     develop novel therapies and improve the success of existing therapies. The main hypothesis~     is that CBT will change levels of the excitatory neurotransmitter glutamate in OCD patients~     in a region of the brain involved in OCD known as the cingulate cortex.~   "
128882|NCT01368497|"~     The purpose of this study is to determine the safety and efficacy of treatment using a~     combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old~     with immunotolerant chronic hepatitis B.~   "
128883|NCT01368484|"~     The aim of this study is evaluated the effect of dietetic supplementation with DHA on human~     sperm quality, antioxidant capacity and sperm DNA damage.~   "
128884|NCT01368471|"~     The goal of this study is to demonstrate the superiority of the MGuard™ stent over~     commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better~     myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation~     myocardial infarction (STEMI).~   "
128885|NCT01368458|"~     This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to~     determine whether patients with chronic schizophrenia or schizoaffective disorder receiving~     two different antipsychotics simultaneously will have any significant change in~     psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects~     of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.~      The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a~     specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric~     Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the~     regular in-patient units of RPC and transferred to the CREF. Following baseline assessments,~     patients will be randomized to continued antipsychotic polypharmacy treatment or to~     systematic conversion to monotherapy.~      Conversion to antipsychotic monotherapy will be assessed across multiple domains of~     psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome~     measure is PANSS total score. The secondary outcome measure is time on medication (all-cause~     dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to~     antipsychotic monotherapy will show minimal change from the control group.~   "
128890|NCT01368393|"~     Background:~      Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA)~     has been used successfully to treat pain of various origins, but few good-quality studies~     have evaluated its role in treating pain and anxiety during colonoscopy.~      Objective:~      To investigate the efficacy of EA in reducing procedure-related pain and the consumption of~     sedatives/analgesics during colonoscopy.~      Design:~      Prospective, randomized, double-blind, sham-controlled study.~      Subjects:~      One hundred and twenty eight consecutive patients undergoing first-time elective day-case~     colonoscopy without previous experience of acupuncture will be recruited.~      Interventions:~      Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA)~     before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including~     Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed~     (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to~     stabilize the needles and to blind the patients and endoscopists to the treatment~     allocation. EA and SA will be continued throughout colonoscopy. A mixture of Propofol and~     Alfentanil, delivered by a patient-controlled syringe pump, will be used for~     sedation/analgesia in both groups.~      Outcome measures:~      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary~     outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation~     rate/time, and episodes of hypotension/desaturation.~   "
128891|NCT01368380|"~     This study evaluates the effect of a psychological intervention to breast cancer patients~     and their partners compared to a control group receiving usual care~   "
128892|NCT01368367|"~     The purpose of this study is to determine whether a high intensity aerobic and resisted~     exercise program will improve physical, functional and psychological outcomes in patients~     post burn injury.~   "
128893|NCT01368354|"~     Summary Diseases due to T. solium and soil transmitted helminths (STHs) are of cosmopolitan~     distribution and strongly linked with poor sanitation and poverty. These infections are to a~     great extent perpetuated by open defecation (OD). Community-Led Total Sanitation (CLTS) is~     an approach in which people in rural communities are facilitated to do their own appraisal~     and analysis, come to their own conclusions, and take their own actions. To date no rigorous~     study has been conducted to evaluate the impact of CLTS on the transmission of~     taeniasis/cysticercosis or STHs, despite the worldwide acclaim which CLTS has received as an~     approach to improve sanitation. The overall aim of the study is to contribute to the~     reduction and subsequent control of T. solium and STH infections through the implementation~     of CLTS approaches in 1 districts in the Eastern Province of Zambia. By using CLTS it is~     hypothesised that toilet acquisition and usage will be increased with a resultant reduction~     in OD which will in turn reduce the transmission of T. solium and STH infections in the~     district. This will be measured by porcine/human cysticercosis prevalence (serological test)~     and STH infections in humans (quantitative coprological test).~   "
128894|NCT01368341|"~     Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection.~     Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement~     about what antibiotic treatment that should be given. An RCT with the three most common~     antibiotics used, will support data for revision of national guidelines.~   "
128895|NCT01368328|"~     The role of micronutrients in diabetes is not well understood. Studies have demonstrated the~     relationship between low chromium serum levels and insulin resistance. This study aims to~     evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients~     with type 2 diabetes.~   "
128896|NCT01368315|"~     A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT~     327 in the Atopy Patch Test model.~   "
128897|NCT01368302|"~     Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either~     Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention~     biases or a placebo control condition not designed to change attention patterns. Outcome~     measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as~     measured by gold standard questionnaires and symptom counts derived from structured clinical~     interviews.~      We expect to see significant Post Traumatic Stress Disorder symptom reduction in the~     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in~     which no symptomatic relief is expected.~   "
128898|NCT01368289|"~     A prospective, multicentre, observational study of all patients referred for endoscopic~     resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat~     analysis.~   "
128899|NCT01368276|"~     The purpose of this study is to learn about the safety and the risks of using talimogene~     laherparepvec in patients who already received treatment with talimogene laherparepvec in~     study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec~     can destroy melanoma tumors.~   "
128900|NCT01368263|"~     This phase II trial studies the impact of a presurgical endocrine therapy, consisting of~     goserelin with letrozole or anastrozole on the treatment of premenopausal patients with~     stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2~     (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body.~     E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth.~     Giving goserelin together with letrozole or anastrozole before surgery may enhance the~     effectiveness of, or eliminate the need for, chemotherapy~   "
128901|NCT01368250|"~     Aortic valve stenosis represents the clinically most important valvular heart disease in the~     elderly patient population. For several decades, surgical aortic valve replacement has been~     considered the standard in the treatment of symptomatic patients with aortic stenosis.~     Patients deemed at excessive-risk for conventional aortic valve replacement were treated~     conservatively with a very poor prognosis. In the search for less invasive treatment options~     for this elderly patient population, transcatheter aortic valve implantation (TAVI) was~     introduced in 2002 and since then has been established as an alternative, less invasive~     treatment option for non-operable or high-risk patients for conventional surgery. The~     purpose of this prospective multi-center, observational national registry in Switzerland is~     to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI~     in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE~     approved devices. All centers in Switzerland implanting the CE approved devices for TAVI~     will be invited to include patients in the registry. Each site will collect baseline and~     procedural data as well as clinical outcome data up to five years.~   "
128902|NCT01368237|"~     Recent advances in technology have resulted in the development of scanners that can image~     the heart blood vessels within 10 to 20 minutes but without the need for admission to~     hospital or insertion of catheters. Further advances in technology allow the visualisation~     of both the blood vessels and the supply of blood to the heart muscle. Here we propose to~     assess the latest and most powerful computed tomography scanner and compare it to magnetic~     resonance and conventional coronary angiography.~   "
128903|NCT01368224|"~     In recent decades, the incidence of subjects presenting reactive skin has considerably~     increased in industrialized countries. Probiotics are live microorganisms which, when~     ingested in sufficient amounts, have beneficial effects on human health. The mechanism~     underlying the effect of probiotics involves, in part, regulation of the composition and/or~     metabolic activity of the intestinal microbiota.. It is postulated that following~     interaction of probiotics with the intestinal epithelium, associated intestinal cells become~     activated and consequently mediators are released into the blood circulation. Mediators,~     activated intestinal epithelial cells and possibly bacterial fractions might reach the skin~     through the bloodstream where they potentially could exert effects.The objective of this~     study was to assess the effects of probiotics on reactive skin symptoms. The strain~     Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain~     Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were~     selected for their immune-modulatory properties demonstrated in in vitro and other~     preclinical studies as well as in a pilot clinical trial.~      Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L.~     paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The~     supplements were administered by the oral route for 58 days (1010 CFU/day).~      The objective of the clinical trial was to determine, in vivo, the effect of food~     supplements on reactive skin symptoms (as measured by skin sensitivity and the~     reconstruction of barrier function post-repeated tape stripping).~      The secondary objectives were to determine the effect of the food supplements on leg skin~     dryness and facial skin roughness and the associated biochemical, immunological and~     microbiological factors.~      Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The~     reconstruction of barrier function was determined by measuring the trans-epidermal water~     loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin~     dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg~     and facial skin dryness themselves. Each analysis was conducted at the various time points.~      In parallel, assessment of the skin moisturizing factors and serum inflammatory and~     immune-regulatory cytokines were performed. Finally, key components of the intestinal~     microbiota were analyzed.~   "
128904|NCT01368211|"~     The PRESS trial is a single-center, two-part, randomized cross-over pilot study in~     Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated~     platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and~     2) the correlation between the TEG® parameters and platelet count increments after platelet~     transfusions in thrombocytopenic subjects.~   "
128905|NCT01368198|"~     The primary objective of this investigation will be to quantify the increase in tear film~     break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular~     Emulsion in dry eye sufferers.~   "
128906|NCT01368185|"~     This was a retrospective, chart review, observational study to assess the effect of MK-0954A~     (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period~     of at least three months on serum uric acid levels.~   "
128907|NCT01368172|"~     The first evidence-based physical activity guidelines for people with spinal cord injury~     were released in March, 2011. This project will evaluate the implementation of the new~     physical activity guidelines in a community exercise setting in Hamilton, Ontario. The~     investigators hypothesize that persons who follow the guidelines will experience increased~     aerobic fitness and muscle strength. The investigators also hypothesize that participants~     will find the guidelines easy to follow and that their self-efficacy for participating in~     physical activity will be improved following the study period.~   "
128908|NCT01368159|"~     The trial objectives are to compare efficacy relative to pain, along the route of the vein~     following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous~     vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg)~     versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be~     the comparison between the first two groups mentioned. All other contrasts will be~     secondary. The Class I compression versus The two class III compressions contrast will~     also be studied.~      Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the~     morning and evaluated by the patient at the end of the day.~      Consumption of analgesics or the number of days of analgesic treatment necessary for the 3~     compression types used will be compared.~      One of the trial objectives is also to show that regular use of a class III compression~     product leads to a reduction in complications following sclerosis (by reducing the number of~     non-serious/serious complications specific to sclerosis: matting, pigmentation,~     inflammation, development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.).~     The trial also aims to compare the rate of successful sclerosis between the three devices,~     success being defined by complete or partial occlusion of the great saphenous vein, leading~     to the disappearance of reflux at the crural level.~      The other secondary objectives will be patient evaluation of comfort, ease of putting on and~     taking off the compression hose and a global appreciation of the procedure for echoguided~     endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by~     wearing compression hose.~   "
128909|NCT01368146|"~     The purpose of this study is to determine whether contact sensitization occurs to the skin~     of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and~     Silicone Vehicle Control dressings.~   "
128910|NCT01368133|"~     The major purpose of this study is to evaluate the changes of multiple organs in patients~     with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples~     and pituitary tumor tissues will be kept for further analysis.~   "
128911|NCT01368120|"~     The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV~     Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.~   "
128912|NCT01368107|"~     The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4~     lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic~     breast cancer patients.~      The primary objective is to determine the optimal schedule to deliver CYT107 during~     chemotherapy based on restoration of CD4 count.~      This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.~      24 patients will be included in the study.~   "
128937|NCT01367782|"~     The purpose of this study is to test the effects of low frequency deep rTMS using the novel~     H-coil on the motor, affective and cognitive deficits in patients with asymmetric~     Parkinson's disease (PD), to establish its safety in this population and to test effects of~     maintenance treatments.~   "
130012|NCT01353664|"~     This study is intended to provide access to Romidepsin for participants who received~     Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation~     and for participants whom the investigator feels may benefit from continuing treatment with~     Romidepsin.~   "
128913|NCT01368094|"~     Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This~     intervention is associated with a high rate of postoperative complications including:~        -  pancreatic fistulas (PF);~        -  surgical site infections (intra-abdominal abscess, wound infection);~        -  delayed gastric emptying (gastroparesis);~        -  and hemorrhage.~      The incidence of SSI (superficial and deep) is about 35% and seems influenced by the~     prolonged intra-abdominal drainage. For several years, there has been a global trend to~     reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical~     trials have shown that prophylactic drainage does not decrease the incidence of~     postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and~     could increase the number of SSI. However, the role of prophylactic drainage after PD is so~     far unclear.~      The aim of this prospective randomized multicenter study is to evaluate the influence of~     early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice)~     drainage removal of the abdominal cavity after PD, on the rate of SSI.~      Materials and Methods: The technique of PD is left at the discretion of the operator as well~     as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made~     of one or two round silicone close suction drains or open multichannel silicone drains~     placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients~     operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy.~     The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner~     images. In case of pancreatic fistula, the patient is excluded from randomization and~     drainage of the abdominal cavity is left in place depending on the different teams'~     practice. Patients without fistula are randomized to either drainage removal 4 days after~     surgery (D4) or standard drainage.~   "
128914|NCT01368081|"~     The objective of the study is to investigate the long-term safety and efficacy of BI 10773~     given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2~     diabetes mellitus with insufficient glycaemic control.~   "
128915|NCT01368068|"~     Many perimenopausal women experience severe mood symptoms for the first time in their life,~     with no past psychiatric history. The importance of clearly identifying and treating a~     disorder that is increasingly referred to as perimenopausal depression is highlighted by~     the wide-reaching impact this can have on the lives of women suffering from it. This is not~     a minor or short term mood disturbance; it is a severe depressive illness, needing effective~     and early treatment. Relationships, employment, participation in social roles and individual~     well-being can all be disrupted by the combination of the mood, hormonal and physical~     changes associated with the transition to menopause. The term perimenopausal depression~     denotes the onset of depression coinciding with the onset of reproductive hormone changes.~      Many women with this type of depression experience serious and long term debilitating~     symptoms. Treatment commonly draws on traditional approaches for the management of major~     depression including the use of antidepressants such as selective serotonin reuptake~     inhibitors (SSRIs) as the first line response. However, standard treatment of perimenopausal~     depression using antidepressants has only shown small improvements at best and at worst, is~     associated with severe side effects. Some SSRIs have been shown to be less effective in~     postmenopausal women compared to child bearing age women. Hormone treatments directly~     targeting the fluctuating reproductive hormone systems (in particular estrogen) through the~     administration of compounds such as tibolone, have significant potential as a better overall~     treatment.~      To date, there is still a lack of clear clinical evidence about the best approach for the~     biological treatment of women with perimenopausal depression. The project we now propose to~     conduct is a 12-week randomised controlled trial (RCT) of 2.5 mg/day tibolone compared to~     10mg/day of escitalopram (an SSRI that has targeted serotonin action)compared to placebo to~     discover the best treatment approach for a hitherto understudied depression that affects a~     large proportion of women in their late forties and fifties.~   "
128916|NCT01368055|"~     The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that~     has as little side effects on normal bladder and rectal tissues as the usual longer course~     (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer~     cells.~   "
128917|NCT01368042|"~     The purpose of this study is to assess health-related Quality of Life (QoL) changes in~     participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT)~     undergoing hemodialysis and receiving paricalcitol intravenous (iv).~   "
128918|NCT01368029|"~     This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated~     influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of~     several strains of Lactobacilli that is used as a probiotic or microorganism administered to~     confer health benefits. Our research is focused on studying the possible therapeutic~     effects of LGG. The study hypotheses are:~        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly~          subjects who have just received the trivalent inactivated influenza vaccine~        2. The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the~          influenza season will be higher in the LGG group than the placebo group~        3. The occurrence rate of influenza like illness during the influenza season will be lower~          in the LGG group than in the placebo group~        4. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56~          and at the end of the influenza season will be greater in the LGG group than the~          placebo group.~   "
128919|NCT01368016|"~     A comparison of two products for oral nicotine replacement with respect to relief of urges~     to smoke after single doses of nicotine.~   "
128920|NCT01368003|"~     In this research study, the investigators are looking to determine the safety and efficacy~     of an investigational drug, STA9090 alone and in combination with dutasteride for the~     treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to~     slow down or shrink by targeting proteins required for the cancer to grow. The investigators~     are also looking to determine whether the use of dutasteride to lower male hormone levels~     will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.~   "
128921|NCT01367990|"~     The study will evaluate the safety of topical norepinephrine in head and neck cancer~     patients who are receiving treatment with intensity modulated radiotherapy (IMRT).~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation-induced alopecia experienced by these patients.~   "
128922|NCT01367977|"~     It is known that 33-50% of Classic and Hypermobile Ehlers-Danlos Syndrome patients~     eventually develop dysautonomia, otherwise known as POTS (Postural Orthostatic Tachycardia~     Syndrome). Some of these patients develop dysautonomia as a result of a retroflexed~     odontoid, Chiari 1 Malformation or cranial settling and the resulting basilar impression.~     Many Ehlers-Danlos patients suffer with the same symptomology with no evidence of a cause~     according to MRI imaging.~      It is the author's hypothesis that low-level External Communicating Hydrocephalus appears to~     be responsible for the constellation of autonomic and cranial nerve symptoms, and if present~     in the very young, an analysis of head circumference growth in the first 15 months of life~     should reflect abnormally rapid head growth, supporting this hypothesis.~   "
128923|NCT01367964|"~     West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three~     features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on~     electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this~     study is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether~     treatment with ACTH will prevent WS.~   "
128924|NCT01367951|"~     Unstable chest injuries are common in poly trauma patients. They can lead to severe~     pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the~     patient to require intubation and mechanical ventilation. Traditionally these injuries have~     been treated non-operatively, however in the past decade there has been numerous studies~     suggesting improved outcomes with surgical fixation. Surgical fixation can significantly~     decrease time spent in ICU as well as day on mechanical ventilation. The investigators aim~     is to conduct a randomized control trial of these injuries, to compare non-operative~     treatment with surgical fixation. The investigators' hypothesis is that surgically treated~     patient will have significantly improved outcomes compared to those treated non-operatively.~   "
128925|NCT01367938|"~     This study tracks the clinical outcomes associated with the OK knee Total Knee Arthroplasty~     (TKA) system.~   "
128926|NCT01367925|"~     This study compares the clinical and radiographic outcomes obtained with the use of the~     Stryker Triathalon Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.~   "
128927|NCT01367912|"~     To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in~     the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)~     cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).~   "
128928|NCT01367899|"~     The objective of this post-approval study is to provide scientifically valid and reliable~     evidence that supports claims of longer term safety and effectiveness with regard to Month~     120 device survivorship rates.~   "
128929|NCT01367886|"~     This study is being done to evaluate the use of a new technology (urine proteomics) - the~     study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a~     simple voided urine specimen.~   "
128930|NCT01367873|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose~     study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196~     in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating~     doses of VIA-3196 or matching placebo.~   "
128931|NCT01367860|"~     Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by~     disc herniation.~      Among the various surgical techniques practiced the percutaneous discectomy occupies its~     space since the first description of the technique by Hijikata, 1975. Throughout, many~     techniques have been described. Studies indicate that the treatment was successful for pain~     and disability resulting from herniated disc associated with radiculopathy small.~      However, some methods remove very small amounts of tissue with little change in volume of~     the disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed~     more macroscopic changes of the disc with a predictable amount of removal and significant~     disc material.~      The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy~     which creates a suction effect in tissues adjacent to the exit point of the fluid and the~     opening point of the collector. However, no studies have examined the effect of the~     Percutaneous Diskectomy by SpineJet ® in humans about the disk size after treatment or~     measures of disc degeneration by imaging methods or how these characteristics might~     correlate with clinical outcomes.~      Thus, the study will compare outcomes of patients with contained or extruded disc~     herniation, with complaints of radiculopathy, concordant with the imaging findings. With~     treatment by surgical technique or the traditional by SpineJet ®, in order to determine~     whether percutaneous discectomy with SpineJet ® will produce results comparable to open~     microdiskectomy.~   "
128932|NCT01367847|"~     The aim of this pilot study is to determine whether a technology-enhanced version of an~     established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon &~     Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8~     children with externalizing problems in treatment. It is predicted that families in both the~     HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in~     parenting behavior and child externalizing problems; however, it is predicted that~     parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to~     be retained in the program, will be more likely to remain engaged in the program (e.g.,~     practicing skills between sessions etc.), and will be more likely to have active involvement~     from their coparenting partners (i.e., other adults and family members who participate in~     childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.~   "
128933|NCT01367834|"~     The purpose of this research study is to learn about brain development in very young girls~     with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain~     development.~   "
128934|NCT01367821|"~     Patients with obstructive jaundice (OJ) often require surgical, endoscopic or radiological~     interventions to facilitate biliary drainage and relieve jaundice. However it is known that~     patients with OJ have increased surgical risks than non-jaundiced patients undergoing the~     same procedures. Surgery for severe OJ is associated with a significant post-operative~     mortality (10-15%) and morbidity (30-65%). The commonest complications are related to sepsis~     but the pathophysiological mechanisms behind this susceptibility to bacterial infection are~     not clear. Recent work has shown a pivotal role of bile in the maintenance of enterocyte~     tight junctions and the expression of tight junction-associated proteins which could account~     for the translocation of enteric bacteria and bacterial products to mesenteric lymph node~     complexes, the portal circulation and subsequently the liver. Some of these bacterial~     products, such as endotoxin and quorum sensing signalling molecules (QSSMs), have~     immunomodulatory properties which may dampen normal immune responses to infection resulting~     in life-threatening organ dysfunction. Bacterial endotoxin and quorum sensing signalling~     molecules (QSSMs) represent good candidates for the mediators of this immune suppression and~     although there is a compelling case for their involvement in the pathogenesis of sepsis,~     evidence to support their involvement in the aetiology of infection in OJ is currently~     lacking.~   "
128935|NCT01367808|"~     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic~     factors. The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold~     and include, e.g., genetic factors, diseases, age and concomitantly administered drugs.~     Oxidation reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes~     (CYP) have been recognized as chief contributors. We have previously shown that drug~     interactions mediated by the inhibition of CYP enzymes may be of major clinical~     significance.~      This study is aimed to examine the possible interactions of low-dose sublingual~     buprenorphine with posaconazole and voriconazole.~      The study will be conducted using a randomized, balanced cross-over design in three phases.~      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within~     ±15% of the ideal weight for height will be recruited for the study. The subjects will be~     submitted to physical examination, determination of previous or present chronic diseases,~     and comprehensive laboratory testing to ascertain that they are in good health. The subjects~     will fill in a modified Finnish version of the Abuse Questions to assess their vulnerability~     for opioid abuse. Laboratory screening will include CBC (including hemoglobin, hematocrit,~     differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase, BUN and creatinine, and~     for women a pregnancy test. Urine will be screened for glucose, proteins and drugs with~     addiction potential. Blood pressure in sitting position must be within normal limits. Base~     line ECG must be normal.~      The subjects will be given in a randomized, cross-over, balanced manner at intervals of four~     weeks either placebo, vorikonazole or posakonazole. On day 5, the challenge dose of 0.4 or~     0.6 mg of sublingual buprenorphine (Temgesic, Schering-Plough) will be administered at~     11.00, i.e. 1 h after the last dose of placebo, voriconazole or posaconazole. The dose is~     0.6 mg after placebo and 0.4 mg after posaconazole and voriconazole. If necessary, naloxone~     (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the severe~     adverse effects of buprenorphine. For nausea and vomiting, intravenous tropisetron will~     used, if needed.~      On day 4, a forearm vein will be cannulated with a plastic cannula for blood sampling. Timed~     venous blood samples will be drawn before the administration of buprenorphine and 0.5, 1,~     1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18-20 hours after administration. Another venous cannula~     will be inserted to the opposite forearm for the intravenous administration of naloxone.~     Urine will be collected for 18-20 hours.~      The psychomotor effects of buprenorphine will be assessed with visual analog scales (Bond~     and Lader 1974) and digit symbol substitution test (Stone 1984) at 1-2 hour intervals up to~     12 hours after buprenorphine administration. Visual analogue scales will be used for the~     following items: alert / drowsy, good / poor performance, no / strong drug effect,~     unpleasant /pleasant feeling, no / extreme nausea. For each pharmacodynamic variable, the~     area under the response-time curve will be determined by trapezoidal rule for 12 hours.~      The analgesic effect of buprenorphine will be evaluated using the cold pressor test.~   "
128936|NCT01367795|"~     Patients in a known palliative setting and with localized symptoms due to tumor growth will~     be evaluated for their quality of life before and after a surgical intervention (primary~     endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a~     intensive care unit, complications, reinterventions will be recorded (secondary endpoints).~     The investigators will also observe patients with conservative treatment.~   "
128938|NCT01367769|"~     Background:~      Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late~     phase CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. The~     inflammatory process of the vessel wall associated with perivascular angiogenesis at the~     time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may~     important in the development of post-thrombotic syndrome (PTS). Therefore the investigators~     will test the value of CEUS to detect venous perivascular vascularization and inflammation~     in patients with acute DVT or SVT.~      Aims:~      To determine the presence and degree of venous perivascular vascularization and inflammation~     assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without~     thrombosis.~      Expected results:~      The investigators hypothesize that venous perivascular vascularization and inflammation~     assessed by contrast agent enhancement can be quantified and will be significantly more~     pronounced in the perivascular tissue of the thrombotic vein than in the non affected vein~     and in controls, and will correlate with level of inflammatory markers and leg volume.~      Significance:~      These results would provide new information on the pathophysiological concept of thrombosis~     and thrombus resolution. It might help to better understand the pathophysiologic mechanisms~     that promote the development of chronic venous insufficiency and PTS.~   "
128939|NCT01367756|"~     This randomized, double-blind, parallel-arm study will assess the safety and tolerability of~     RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive~     citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or~     placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.~   "
128940|NCT01367743|"~     The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after~     reperfused myocardial infarction will be compared, by following cardiac index evolution as~     main criteria. The study is a pilot pathophysiological study, randomized, double blind and~     multicenter.~   "
128941|NCT01367730|"~     In the context of male osteoporosis, we hypothesize that regional changes in trabecular~     bone, as well as changes in cortical porosity will play a major role, and thus also affect~     bone strength. In developing therapeutics the response of individual compartments, regional~     variations post-therapy will have considerable impact on selecting the therapies as well as~     monitoring response to therapy. This study, a precursor to other therapeutic trials, will~     lay the ground-work for the future.~   "
128942|NCT01367717|"~     Background: Creatinine (Crn) concentration is used to assess renal function via calculation~     of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney~     Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a~     two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of~     proteins and circulating creatine, and it is generally a benign product present in serum.~     Creatine is a nutritional supplement that has been available since 1993, and it is widely~     used among athletes today.~      Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2~     creatine supplements to determine any associated statistically significant increase in serum~     Crn and clinically significant increase in serum Crn to a degree associated with AKI or ARF.~     Urine samples were also collected to examine excretion patterns after an ingested sample.~     Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and~     had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at~     0, 1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of~     creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair~     Signed Ranks Test and descriptive summary statistics were performed.~   "
128943|NCT01367704|"~     Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent~     females and substantial reports of perpetration by young males, effective prevention~     programs to prevent ARA are limited. Male athletes are an important target for prevention~     efforts given their higher rates of abuse perpetration compared to non-athlete peers as well~     as their social influence among their peers. This cluster-randomized school-based~     investigation examines the effectiveness of a program for the primary prevention of ARA.~     Coaching Boys into Men (CBIM) is a social norms theory-based program intended to alter~     norms that foster ARA perpetration, promote bystander intervention, and reduce ARA~     perpetration by engaging athletic coaches as positive role models to deliver violence~     prevention scripts and tools to high school age male athletes. Coaches receive a 60-minute~     training session to administer the intervention to their athletes via 11 lessons across a~     sport season. Trained high school coaches talk to their male athletes about 1) what~     constitutes disrespectful and harmful vs. respectful behaviors, 2) promoting more~     gender-equitable attitudes, and 3) modeling bystander intervention when disrespectful~     behaviors toward women and girls are witnessed. The current investigation evaluates the~     intervention in 16 urban high schools randomized either to receive the CBIM program (i.e.,~     intervention schools, n=8) or to a control condition (n=8). Baseline computer-based surveys~     are collected for all intervention and control site student athletes entering grades 9~     through 12 at the start of each of three sports seasons across Year 1 (Time 1). Follow up~     surveys are collected for these same athletes at the end of their first sports season (Time~     2). Participating athletes in grades 9 - 11 at baseline are re-surveyed 12 months after Time~     1 to examine the longer term effects of the CBIM intervention (Time 3; N of athletes~     completing all 3 waves of data collection = 1500). Primary assessment of intervention~     effects are based on intent-to-treat estimates, utilizing generalized linear mixed models to~     account for clustering arising from school randomization. Hypothesized outcomes for male~     athletes include a) an increase in recognition of what constitutes abusive behaviors, b)~     more gender-equitable attitudes, c) an increase in intentions and reports of bystander~     intervention regarding ARA, and through these intermediate outcomes, d) a decrease in~     perpetration of ARA among adolescent male athletes.~   "
128944|NCT01367691|"~     Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients~     with CRT.~      Goals are to demonstrate that~        -  differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause~          differences in myocardial activation~        -  differences in LV-RV pacing delays cause differences in LV/RV hemodynamics~      and to use these data to optimize CRT.~   "
128945|NCT01367678|"~     In the following randomized non-crossover study, the investigators test the hypothesis that~     directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme~     and the i-Gel in paralyzed anesthetized females.~      Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA~     Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA~     Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal~     oropharynx; C, hypopharynx; and D, pyriform fossa.~      Insertion success rate and oropharyngeal leak pressure were also measured.~   "
128946|NCT01367665|"~     This single-arm, open-label, multi-center study will evaluate the safety and efficacy of~     vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma.~     Patients will receive oral doses of vismodegib 150 mg once daily until disease progression~     or unacceptable toxicity.~   "
128947|NCT01367652|"~     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted~     conditions.~   "
128948|NCT01367639|"~     Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a~     substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be~     detected. The only proven modality for active risk reduction (rather than passive early~     detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the~     majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age~     40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of~     being a mutation carrier is the emotional stress associated with that discovery.Genetic~     information has profound implications for mutation carriers. The IBSR (Inquiry-based stress~     reduction) intervention, developed by Byron Katie, trains participants to reduce their~     perceived level of stress by self-inquiry of their thoughts and beliefs connected to~     stressful circumstances or symptoms. This meditative process, named The Work, enables the~     participants to identify and question the stressful thoughts that cause their suffering. The~     core of IBSR is simply four questions and a turnaround, which is a way of experiencing the~     opposite of what the participant believes. This process is simple, powerful and provides~     skills for self-inquiry and management of stressful thoughts that can be easily implemented~     in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we~     postulate that the clinical utility of IBSR mediation program may improve psychological and~     physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/~     BRCA2 mutation carriers. Thus, we will conduct a pilot randomized controlled trial to~     scientifically investigate the effect of this intervention effects on BRCA1/2 mutation~     carriers.~   "
128949|NCT01367626|"~     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed~     conditions.~   "
128950|NCT01367613|"~     This is a 3 month open-label extension study that allows patients who completed Protocol~     MNTX 302 to receive SC MNTX.~   "
128951|NCT01367600|"~     This study is an open-label extension allowing patients who have completed Protocol MNTX 301~     to continue to receive SC MNTX.~   "
128952|NCT01367587|"~     This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.~   "
128953|NCT01367574|"~     This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous~     methylnaltrexone to be conducted in patients with advanced medical illness and poorly~     controlled opioid induced constipation. Patients will be randomized to one of three fixed~     dose levels of SC MNTX.~   "
128954|NCT01367561|"~     This is a double-blind, randomized, study at a single clinical site investigating the effect~     of methylnaltrexone and naloxone versus placebo in healthy males who have received a~     short-acting opioid, remifentanil.~   "
128955|NCT01367548|"~     A double-blind, randomized, parallel-group study designed to evaluate the safety and~     activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent~     segmental colectomies via laparotomy.~   "
128956|NCT01367535|"~     This study is a single-center, randomized, open-label, active and placebo-controlled,~     parallel-group, conducted in healthy male volunteers who have been shown to be extensive~     metabolizers of dextromethorphan.~   "
128957|NCT01367522|"~     This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will~     receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight~     subjects from each classification of hepatic impairment will be enrolled. Plasma samples~     will be collected before and at specified intervals after dosing and the concentration of~     MNTX will be analyzed.~   "
128958|NCT01367509|"~     This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in~     patients with mild, moderate, or severe renal impairment who do not require hemodialysis.~   "
128959|NCT01367496|"~     This is an open-label, Phase I study. Study treatments will entail a four-way crossover~     among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six~     healthy normal male volunteers. Blood samples will be obtained to determine plasma~     pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability~     versus an intravenous dose.~   "
128960|NCT01367483|"~     This is an open-label, radiotracer study, to be conducted in healthy, normal, male~     volunteers. It will entail intravenous administration of a single dose of 14C-MNTX,~     collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be~     sampled as a measure of the extent of possible metabolic MNTX demethylation.~   "
128961|NCT01367470|"~     The newborn immune system is influenced by maternal immunity through both placenta and~     breastfeeding.~      There exists a close interaction between the mother and the baby during gestation and~     lactation. Maternal milk contains a number of factors that protect the newborn against~     infections including 1) cytokines and their receptors which are also thought to play a role~     in the protection against allergies; 2) oligosaccharides with low molecular weight and 3)~     probiotic bacteria that contribute to the development of the newborn immune system.~      Probiotics have a potent immunogenic activity as well as an immunoprotective potential in~     maternal milk after administration of probiotics during pregnancy and breastfeeding. In~     addition probiotics are supposed to play a role in the increased production of~     sphingomyelinase.~   "
128962|NCT01367457|"~     The principal objective of the study is to evaluate the efficacy and safety of temsirolimus~     use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.~   "
128963|NCT01367444|"~     Primary Objective:~      To assess the safety and tolerability of ascending doses of SAR422459 in patients with~     Stargardt's Macular Degeneration.~      Secondary Objective:~      To evaluate for possible biological activity of SAR422459.~   "
128964|NCT01367431|"~     The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN).~     Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also~     found in beer itself. Studies in animals have shown that XN can lower blood sugar and blood~     lipids such as triglycerides, which can contribute to heart disease. The purpose of this~     study is to see how much of the XN is absorbed into the blood and how fast it leaves the~     body when taken by mouth. Once the PK study has been done, the investigators' long-term goal~     is to learn if xanthohumol can lower risk factors for heart disease and type-2 diabetes in~     humans.~   "
128976|NCT01367275|"~     The goal of this clinical research study is to learn if adding brivanib to irinotecan can~     help control the disease in patients with colorectal cancer that has spread. The safety of~     this drug combination will also be studied.~   "
128965|NCT01367418|"~     Several recently published retrospective studies show that regional anaesthesia (RA) can~     reduce cancer-related mortality following surgical treatment of colorectal, breast and~     prostate cancers and malignant melanoma. If these results are true, then the choice of~     perioperative pain management is as beneficial, or even better, than the current oncological~     therapies. This theory needs to be investigated in a prospective, randomized and controlled~     trail. We shall perform a prospective, randomized study comparing the effects of Thoracic~     epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative~     immunological and inflammatory markers in order to understand whether the protective~     effects, if any, of regional analgesia are due to changes in these markers or whether the~     underlying mechanisms is not mediated via this stress signalling pathway.~   "
128966|NCT01367405|"~     Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical~     entity. The most characteristic feature is the disproportionate more motor impairment of the~     arms and especially the hands than the legs, bladder dysfunction and sensory.~      Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal~     cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord~     lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact~     incidence is not known.~      Uncertainty about the treatment exists. A good recovery has been described after~     conservative treatment. Conservative treatment was usually considered when a fracture or~     dislocation of the spine were absent. It is often seen in hyperextension trauma in the~     elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest~     a better outcome after surgical decompression. Randomized trials have not been performed. To~     avoid discussion about possible confounding or effect modification related to the mechanism~     of trauma, this study will focus on ICSCL in patients without fracture or instability of the~     cervical spine on radiological examination. Also the problem of crossover from the~     conservative group to the surgical one due to the nature of spinal instability will be~     reduced.~      Goal of the study: To compare the efficacy of early decompressive surgery to improve~     functional outcome in patients with ICSCL without a fracture or instability of the cervical~     spine compared to those receiving conservative treatment.~      Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a~     cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that~     could indicate a fracture of the cervical spine or instability. An overt sequestrated~     herniated disc should not be present since this will always necessitate immediate surgery.~     Involvement of the cervical spinal cord should be established at physical examination~     (symptomatic arm or hand dysfunction is obligatory).~   "
128967|NCT01367392|"~     The purpose of this study is to confirm the safety and effectiveness of the ActiSight™~     Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and~     ablations . The device used in this study is designed to assist the physician in guiding the~     needle towards the suspected area. This device does not change the procedure of liver biopsy~     or ablation. The only difference is that a small adhesive pad is placed on the skin and a~     miniature video camera is attached to the end of the needle. This camera does not enter the~     body.~   "
128968|NCT01367379|"~     The investigators will study in the possibility of cardiovascular disease, caused by the~     duty loading, of physician of internal medicine. The investigators will also explore if~     there {dose response effect} between the duty loading and the stress response of physicians~     of internal medicine. Therefore, the investigators will compare the stress responses of~     physicians of internal medicine during with different duty loading ( non-duty day, one duty~     area with 3 wards, 2 duty areas with 6 wards) in a observational method. Those stress~     response will be measured by cardiovascular risk indicators, including blood pressure, heart~     rate variability, blood sampling and urine sampling.~   "
128969|NCT01367366|"~     Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary~     depending on early detection, histologic types and staging. Because the mediastinal~     involvement including lymph node status is a significant prognostic factor for survival,~     lymph node biopsy is necessary for clinical staging of some patients. Although~     fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise~     evaluation of mediastinum, tissue proof of PET positive lesions are recommended due to its~     limited diagnostic specificity for identifying mediastinal metastases. Cervical~     mediastinoscopy remains the gold standard for mediastinal lymph node sampling. However, it~     is invasive, requires general anesthesia. Another new minimally invasive method of~     mediastinal biopsy is real-time endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA). The aim of this study is to compare the accuracy of PET and~     EBUS-TBNA for correct staging of the mediastinum for lung cancer patients.~   "
128970|NCT01367353|"~     Specific aims: Identification and characterization of cancer stem cell-like population~     (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites~     and peripheral blood of ovarian cancer patients and genetically engineered mouse ovarian~     cancer cell lines.~      Objectives: In the future, individualized therapy must incorporate analysis of the cancer~     stem cells or cancer initiating cells of ovarian cancer cells when designing therapeutic~     strategies for ovarian cancer patients.~      Aims of this project:~        1. Isolation and identification of cancer stem cell-like population (cancer stem cells or~          cancer initiating cells) from primary tumor tissue, primary ascites and peripheral~          blood of ovarian cancer patients~        2. In vivo tumorigenicity assay will be performed to measure tumor formation from these~          cancer stem cell-like population when equal numbers were injected into the dorsal fat~          pad of nude mice.~        3. To establish a standard protocol of stem cell-like population maintenance~        4. Screening of potential specific biomarkers involved in these ovarian cancer stem~          cell-like population.~   "
128971|NCT01367340|"~     The purpose of this study is to investigate the effects of a 6-month physical activity~     intervention program on mobility and participation after the termination of a 6-week~     functional strengthening program for school-age children with spastic diplegia cerebral~     palsy. The primary outcomes are gross motor function, participation, and physical activity~     behavior.~   "
128972|NCT01367327|"~     The purpose of study is to investigate the effects of PSE Music with a home-based loaded~     STS exercise program on the functional strength, gross motor function, daily participation,~     exercise involvement, motor control, and gait speed for children with spastic diplegia.~   "
128973|NCT01367314|"~     This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5%~     NVC-422 topical gel in children with impetigo.~   "
128974|NCT01367301|"~     This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating~     patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or stopping them from dividing.~     Giving radiation with chemotherapy may kill more tumor cells.~   "
128975|NCT01367288|"~     Breast cancer is the leading female cancer by a very wide margin in France. Despite~     widespread breast cancer screening, many cases of breast cancer are discovered at a locally~     advanced stage. The tumoral consequences of a cancer size greater than 3 cm are: increased~     risk of metastasis and death and, most often, impossibility of performing breast-conserving~     surgery (a mastectomy is usually advisable in case of a first surgical procedure). It is~     increasingly recommended to treat locally advanced breast cancers with neoadjuvant~     chemotherapy. Very numerous studies have shown that by proceeding that way, the oncologic~     prognosis was not harmed and, on the contrary, it was possible to obtain sufficient tumor~     response to allow breast-conserving treatment in more than 60% of cases.~      The use of zoledronic acid (Zometa) has an established place in the management of~     malignancies with a predilection for skeletal involvement (in particular metastasis).~     Although the main target of biphosphonates is the osteoclast, there is also preclinical data~     indicating that biphosphonates can have effects on cells other than osteoclasts, including~     tumor cells. Anti-tumor activity including inhibition of tumor cell growth and induction of~     tumor cell apoptosis, inhibition of tumor cell adhesion and invasion, and anti-angiogenic~     effects have been demonstrated. In addition several in vitro studies have shown that Zometa~     causes synergistic induction of breast cancer cell apoptosis when combined with clinically~     relevant concentrations of chemotherapy drugs such as paclitaxel and doxorubicin. Therefore~     testing of combinations of biphosphonates with these agents in breast cancer is of~     significant interest.~      In the context of locally advanced breast cancers, the combination of a bisphosphonate with~     neoadjuvant chemotherapy appears to have an important potential: preventing possible bone~     metastases, but also possibly amplifying the efficacy of the chemotherapy's tumoricidal~     activity, both on the primary tumor and on potential metastatic localizations.~      So it appears that, the use of bisphosphonates in a neoadjuvant situation presents a~     potentially favorable benefit-risk ratio. That is why we are proposing to perform a~     prospective randomized multicenter comparative study to evaluate 2 systemic neoadjuvant~     treatments, one with Zometa and the other without Zometa, in patients with locally advanced~     breast cancer. Zometa will be administered according to the usual administration procedure:~     one infusion every 3 weeks.~      The therapeutic response will be evaluated by studying the different biological markers~     (circulating blood and bone marrow tumor cells, serum cell apoptosis and neoangiogenesis~     markers, bone resorption markers, etc.), but also by analyzing clinical, radiologic, and~     histologic response and by breast conservation rates. The impact of other factors that may~     affect therapeutic response will be taken into account: aggressivity of the tumor, presence~     or absence of tumor receptors, tumor stage, etc.~      The purpose of the study is to show a marked benefit of treatment with Zometa in managing~     locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy and~     improvement in the laboratory parameters of tumor aggressivity. These markers will be used~     as surrogate markers of long term outcome.~   "
128979|NCT01367236|"~     The purpose of this study is to compare two different combination anti-HIV therapies over 48~     weeks and to assess if differences in improvement in the function of the brain are observed~     over this period.~      The study will compare anti-HIV therapy combinations which are currently in use.~      The patients will not have had any previous treatment for their HIV infection.~   "
128980|NCT01367223|"~     This study aims to describe the use of glutamine supplementation in the modulation of~     inflammatory response in critically ill pediatric patients and to determine if this decrease~     leads to clinical improvement in morbidity and mortality in these patients. Thus, these~     patients' diet could be supplemented with glutamine in order to improve their evolution.~      Hypothesis:~      From the data obtained in the study of the literature the investigators consider that:~      Critically ill patients have a deficit of glutamine either because of an increase in its~     consumption or a decrease in its availability, and therefore blood glutamine levels are low.~      Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).~      In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The~     administration of glutamine supplements to these patients decreases oxidative stress due to~     the increase in HSP-70.~      Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.~      The administration of glutamine supplements in these patients increase IL-10 levels.~      Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.~   "
128981|NCT01367210|"~     Objectives of the study:~        1. To verify the safety and the efficacy of the study treatment, defined as the persistent~          control of the virus' replication at 48 weeks after the simplification to maraviroc +~          darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.~        2. To collect relevant information about the safety, the immunologic and the economic~          impact of this strategy.~   "
128982|NCT01367197|"~     PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic~     heart failure, while little is known about the effect in atrial fibrillation (AF). The~     investigators studied the effect of physical exercise on cardiac output (CO), max. exercise~     capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of~     physical exercise training three times weekly for twelve weeks.~      HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity,~     biomarkers and quality of life (Qol) in patients with AF.~      METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and~     muscular strength was performed before and after 12 weeks.~      Resting echocardiography was done at baseline. CO was measured using impedance cardiography~     at rest and during maximal exercise testing on an ergometer bicycle. Body composition,~     muscular strength and six minutes walking capacity were measured before and after the~     training period. Qol was evaluated by the use of the standardized validated questionnaires~     Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).~      Training consisted of aerobic exercise at 70 percent of max. capacity estimated by~     Borg-scale.~   "
128983|NCT01367184|"~     Inferior vena cava (IVC) filter is an important therapeutic device used in the management of~     venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation~     therapy. While there has been significant increase in the use of filters , unfortunately~     there are no standardized collection of data to track, compare outcomes, report safety and~     efficacy.~   "
128984|NCT01367158|"~     This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a~     meningococcal vaccine formulation in adolescents.~   "
128985|NCT01367145|"~     The principal aim of the study is to determine the effects n3-PUFA on top of standard~     therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.~      Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.~      Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation~     using brachial artery ultrasound.~      Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse~     wave velocity, whole blood viscosity, platelet activation and plasma markers of~     inflammation.~   "
128986|NCT01367132|"~     The primary objective of this study is to determine the detection rate of two- or~     three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13~     6/7 weeks gestation.~      Hypothesis: Detection rate of the number of vessels during first trimester will be as~     accurate as the detection of vessels during the second trimester.~   "
128987|NCT01367119|"~     Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT)~     accelerate the antidepressant effect of ECT?~      The study hypothesis was that depressed subjects receiving ECT with ketamine as the~     anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression~     ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic~     agent.~   "
128988|NCT01367106|"~     The main objective of this study is to show that the fetal exposure to excess of~     glucocorticoids is associated with a deficiency of the function beta insulin in the~     offspring adult.~   "
128989|NCT01367093|"~     The purpose of this study is to identify within a cohort of ICU patients admitted for severe~     illness those who are at risk of death in the year following the discharge from ICU.~   "
128990|NCT01367080|"~     To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride~     film-coated tablet 10mg & 25mg~   "
128991|NCT01367067|"~     The objective of the study is to search for possible predictors for claustrophobia during~     magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete~     examination, or a complete examination that requires coping actions by the staff. Coping~     actions may consist of the administration of sedatives, prism glasses, an MR imaging test~     run with the patient, a pause, the prone position, an escort in the scanner room, and~     supportive communication. The investigators hypothesize that there is a difference between~     patients with and without events in their scores on the Claustrophobia Questionnaire and~     several further psychometric questions. Other factors may also favour events like patient~     characteristics, examined region, duration of the examination and scanner type. Therefore,~     predictors could identify patients who are likely to experience claustrophobia during MR~     imaging so that they can receive the appropriate support by the staff to complete their~     examination. Thus a larger patient population could benefit from MR imaging.~   "
128992|NCT01367054|"~     The objective is evaluate, in healthy volunteers, the bioavailability of two products~     containing metformine 500 mg to determine if they are bioequivalent and identify the~     occurrence of adverse events.~   "
128993|NCT01367041|"~     The aim of this study is to investigate effects of femur exposed to vibration on the rest~     muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis.~      Among patients who will be admitted to the investigators clinic for out-patients and whose~     bone densitometric measurement will be made with a prediagnosis postmenopausal osteoporosis,~     a total of 80 voluntaries [40 having postmenopausal osteoporosis (femur neck or total hip T~     score < -2.0) and 40 Controls (Hip and lumbar bone mineral density normal)] are planned to~     include in this study.~      After the left hip bone mineral density (BMD) and BMC is measured in all cases, whole body~     vibration will be applied in PMO groups and Controls. The rest muscle electrical activity of~     left hip muscles will be evaluated at pre-treatment, post-treatment and, during treatment in~     patients with PMO and then their data will be compared with Controls data.~      Plasma sclerostin level will be measured before and 10th minute after vibration.~      Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and~     amplitude of 2 mm for 30 + 30 seconds. WBV will be applied one session only. The left hip~     BMD and BMC will be evaluated by bone densitometer (Norland).~      The rest muscle electrical activity of hip adductor muscles at rest will be measured by~     PowerLab (data acquisition system, ADInstruments, Australia) device.~      This project is planed to be completed in 3 months.~   "
128994|NCT01367028|"~     Multicenter randomised phase II study of neoadjuvant therapy in HER2 positive early breast~     cancer. Primary aim is to evaluate the cardiac toxicity of the combined treatment~     (trastuzumab, docetaxel, bevacizumab, NPLD) in comparison to the standard therapy.~   "
128995|NCT01367015|"~     The purpose of the study is to compare early versus late initiation of enteral feeding in~     premature growth restricted babies below the gestational age of 35 weeks born to mothers~     with prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the~     blood flow from the mother to the baby brings all the nutrients required for growth and the~     very vital oxygen required for survival. These deprived babies with poor blood flow adapt to~     the not so conducive uterine environment by certain adjustments in blood supply to internal~     organs. This permits the best possible blood flow to brain heart etc., which are the vital~     organs and whose adequate functioning is required for survival. As a consequence, the gut~     (intestines) gets poor blood supply and hence its appropriate functioning may be~     jeopardized. Such 'premature growth restricted' babies are at increased risk of further~     growth faltering if not fed adequately as also to a condition called 'Necrotising~     enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal~     distension, blood in stools and inability to feed for longer durations thereby further~     affecting growth. In the past such babies (after birth) were not fed for days together which~     compromised their growth even further. It is not clear whether continuing to withhold feeds~     for prolonged duration will prevent NEC but lead to growth faltering and initiating feeds~     early will potentiate NEC with further compromised growth and increased morbidity. There are~     no randomized trials on feeding strategies in this group of neonates and hence the~     investigators planned to carry out this study on comparison of early versus delayed~     initiation of feeding in preterm SGA infants with AREDF.~   "
128996|NCT01367002|"~     The primary objective of this study is to estimate whether the addition of trastuzumab to~     paclitaxel and carboplatin chemotherapy improves progression free survival when compared to~     paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients~     overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence~     in situ hybridization (FISH).~   "
128997|NCT01366989|"~     The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle~     Arthroplasty in patients having a calcaneal stem.~   "
128998|NCT01366976|"~     Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary~     bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to~     an increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin.~     Free plasma hemoglobin and myoglobin have been shown to be independent predictors of the~     acute kidney injury that results from CPB. When these hemeproteins are released into the~     plasma, they undergo redox cycling, generating radical species that initiate lipid~     peroxidation and a cascade of oxidative damage to cellular membranes, notably in the kidney.~     F2-isoprostanes and isofurans are sensitive and specific markers of oxidative stress in~     vivo, and are increased after CPB, particularly in those patients with acute kidney injury.~     Acetaminophen inhibits the lipid peroxidation catalyzed by myoglobin and hemoglobin.~     Moreover, in an animal model of rhabdomyolysis-induced kidney injury, acetaminophen~     significantly attenuated the decrease in creatinine clearance compared to control. The~     current proposal tests the central hypothesis that acetaminophen will attenuate the lipid~     peroxidation associated with the hemolysis and rhabdomyolysis that occur in patients~     undergoing CPB. Demonstration that acetaminophen inhibits the lipid peroxidation resulting~     from CPB would provide a rationale for a prospective randomized trial to test the hypothesis~     that acetaminophen will reduce the acute kidney injury that results from CPB.~   "
128999|NCT01366963|"~     A common complaint among people with Postural Tachycardia Syndrome (POTS) is brain fog or~     difficulty concentrating. This is very poorly understood. To better understand this~     cognitive dysfunction, the investigators will test people with POTS and people without POTS~     using various neuropsychiatric instruments. The investigators hypothesis is that people with~     POTS will have greater abnormalities on neuropsychiatric testing than normal controls.~   "
129000|NCT01366950|"~     The purpose of this study is to determine if intelligent physical exercise training can~     increase the productivity of office workers in Denmark. Effects of intervention is measured~     after 1 and 2 years.~      The project is driven as a change project.~      The investigators measure productivity as:~        -  Individual health~        -  Sick leave~        -  Retention at the workplace~   "
129015|NCT01366742|"~     The natural history of human papillomavirus (HPV) is most likely influenced by both innate~     and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors~     (TLR) play an important role in cervical innate immunity to HPV through secretions of~     proinflammatory, chemotactic and anti-viral cytokines. Up-regulated TLR expression will also~     result in activation of dendritic cells and T cells that in turn will promote a T helper~     (Th) l like response through secretion of several cytokines and consequently, the induction~     of a successful cell mediated immune (CMI) response.~   "
130032|NCT01353404|"~     The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate~     160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.~   "
129001|NCT01366937|"~     The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and~     fed to healthy human subjects to determine B12 bioavailability from eggs.~      The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12~     to a level that allows us to feed the enriched eggs to humans and determine how much of the~     vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good~     dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence~     Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin~     B12. This allows us to do this experiment with a level of radioactive B12 that is not~     harmful to animals or humans. The results of the investigators first experiment indicate~     that the investigators can inject radioactively labeled vitamin B12 into a laying hen and~     detect the radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans~     in a bioavailability study.~   "
129002|NCT01366924|"~     The modern warfighter faces numerous physiological challenges including sleep deprivation,~     sustained intense physical activity, and caloric restriction, the combined effects of which~     may result in the loss of lean body mass and decreased physical performance. Dietary~     interventions may help preserve lean body mass and facilitate recovery from periods of~     intense physical demand. For example, dietary strategies that increase amino acid~     availability have been shown to stimulate protein synthesis in skeletal muscle following~     resistance exercise. Because military tasks also incorporate endurance exercise components,~     studies regarding the effects of increasing dietary amino acids following endurance exercise~     are warranted. The objectives of this study are to characterize the effect of endurance~     exercise on protein synthesis and breakdown as well as the ability of an essential amino~     acid supplement to influence skeletal muscle protein metabolism and its cellular and~     molecular regulation following endurance exercise.~   "
129003|NCT01366911|"~     This is a pilot study to provide preliminary data of the association between bone mineral~     denity adjacent to acetabular implants, as measured by quanitative computed tomography~     (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell~     assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict~     orthopaedic surgical outcomes.~   "
129004|NCT01366898|"~     The protocol objective is providing adequate treatment and based on broad consensus in~     elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that~     enables a joint analysis of results strong enough to make conclusions on specific subgroups~     of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of~     age or associated diseases). Provide results of a treatment to consider standard against~     which to compare the results of phase II trials of experimental drugs that undoubtedly will~     be activated in the coming years~   "
129005|NCT01366885|"~     The purpose of this study is to determine whether by administering vitamin D to mothers who~     already have at least one child with autism and who are pregnant, that the vitamin D will~     prevent the recurrence of autism in the newborn sibling.~   "
129006|NCT01366872|"~     This is a research study which is being done to determine the outcomes following Agility LP~     ankle replacement. This implant was approved by the FDA in 2007 and has been used since then~     with good early results. You are being asked to volunteer for this study because you have~     undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is~     to compare the range of motion, level of pain and function during daily living prior to and~     after your ankle surgery.~   "
129007|NCT01366859|"~     This study will evaluate the effects of a cysteine-rich whey protein isolate supplement~     (Immunocal®) on autistic behavior in pre-school children with autism.~   "
129008|NCT01366846|"~     ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).~      Peanut Allergy, a recognized public health concern, is a common and potentially~     life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study~     evaluated whether early exposure to peanut promotes tolerance and provides protection from~     developing peanut allergy in children who are allergic to eggs or who have severe eczema.~     ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the~     effect of twelve months of cessation of peanut consumption in LEAP Study participants who~     consumed peanut and those who avoided peanut over the previous five years.~   "
129009|NCT01366833|"~     According to the Canadian Cancer Society there are approximately 1700 new cases of~     esophageal cancer per year in Canada. As most of these patients are diagnosed in advanced~     stages of the disease, 1800 deaths are estimated from this cancer annually . Progressive~     dysphagia is the most common presenting symptom and impacts not only the patient's quality~     of life but the ability to tolerate life prolonging treatments such as systemic~     chemotherapy.~      Although there are several therapeutic modalities to alleviate malignant dysphagia including~     laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the~     most commonly employed. However, the optimal approach to effective, timely treatment of~     malignant dysphagia remains a challenge. The investigators conducted a preliminary~     retrospective review to investigate such palliation procedures and found that a~     multi-modality approach may yield the most favourable results .~      Therefore, our clinical trial will examine the effectiveness of adding a single dose of~     brachytherapy to patients with severe dysphagia who have already been treated with a~     endoscopically placed self-expanding metallic stent.~   "
129010|NCT01366820|"~     The purpose of this study is to determine whether NNZ-2566 is safe and effective in the~     treatment of Traumatic Brain Injury (TBI).~   "
129011|NCT01366807|"~     Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of~     such criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ)~     in cardiac surgery is controversial and insufficiently studied. Furthermore, there is some~     known predictors of poor outcome, which closely related to nutritional status (C-reactive~     protein, total lymphocyte count). The aim of this study is assessment of several nutritional~     screening scales, objective nutritional criteria and predictors for the purpose of detection~     of most informative one or its combination.~   "
129012|NCT01366794|"~     Study hypothesis is to examine the relative contribution of macronutrients for gut hormone~     secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes.~     Individual macronutrients or a mixed meal will therefore be served and gut hormones are~     measured during the following 300 min.~   "
129016|NCT01366729|"~     Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30%~     remain unable to walk and up to 60% are left with moderate to severe walking disability.~      Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side~     influence ipsilesional cortical plasticity and improve functional outcomes. Canes are~     commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle~     activity. We have shown that an orthosis TheraTogs ( elastic corset supporting hemiplegic~     side) significantly increases hemiplegic muscle activity during gait.~      To date no clinical studies have investigated the long term effects of these techniques on~     gait recovery following stroke.~      This study aims to determine if advances in the understanding of cortical plasticity and its~     relation to functional recovery following stroke can be applied to clinical gait~     rehabilitation to improve long term outcomes.~      Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and~     inhibit balance reactions. In the long term this causes poorer walking ability and balance~     and consequently reduced social participation.~      Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and~     facilitate balance reactions. In the long term this improves walking ability and balance~     leading to increased social independence and participation.~      Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke~     patients Intervention When subjects can walk unaided on even ground whilst requiring verbal~     prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into~     intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip~     extensor and abductor musculature according to a standardized procedure. Cane walking with~     cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout~     the day with the assigned walking aid. Standard therapy treatments and usual care will~     remain unchanged and documented.The intervention will continue for five weeks or until~     patients have reached FAC 5 (independent walkers on all surfaces).~      Measures: the day before intervention begin, the day after intervention completion (max 5~     weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed up and go~     test Secondary outcomes surface EMG of hemiplegic lower extremity musculature,~     temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.~      Results Significance levels will be 5% with 95% CI`s. ITT analyses will be performed.~     Descriptive statistics will be presented. Relevant co-variables will be identified and~     analysed. Discussion This study could have significant implications for the clinical~     practice of gait rehabilitation after stroke in particular the effect and appropriate use of~     walking aids~   "
129017|NCT01366716|"~     Contingency management (CM) is a demonstrably efficacious intervention for substance abuse~     and dependence. Although CM protocols have employed a variety of reinforcers, they have~     almost exclusively relied upon non-cash privileges (e.g., take-home methadone doses),~     prizes, or vouchers that can be exchanged for goods or services. Despite the strong~     empirical support for CM, our research suggests that concerns relating to its cost and~     safety (e.g., potential for harm caused by rewards undermining intrinsic motivation or being~     sold to purchase drugs) have hindered its transfer to real-world practice. The exclusive use~     of non-cash CM likely stems from the untested assumption that clients will use cash~     incentives to buy drugs or engage in other high-risk behaviors. This assumption is~     problematic for two reasons. First, the use of non-cash incentives may add substantial costs~     and complexity to CM protocols. Second, the use of non-cash incentives may reduce the~     efficacy of CM interventions, as research suggests that cash may be a more effective~     reinforcer than vouchers. This study examines both practical and ethical issues relating to~     cash-based CM procedures. This study consists of three phases; a main experiment, a Cash~     Bowl pilot, and a Thinning Pilot.~   "
129018|NCT01366703|"~     Patients with heart failure have a high incidence of atrial fibrillation (AF)and~     re-admission for heart failure. New methods have been developed to continuously monitor~     arrhythmia's and heart failure parameters. One such method is implantation of an implantable~     loop recorder. Also home-monitoring is available for continuous monitoring and information~     sending to the treating physicians, with improving detection of atrial fibrillation (AF)~     and/or other sever arrhythmia's we hope to improve patient care.~      Objective of the study:~      To investigate the clinical efficacy in detecting clinically relevant arrhythmia's~     (especially AF) of the Reveal XT in patients with mild to moderate heart failure and~     elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2),~     currently not treated with oral anticoagulation (OAC).~      Study design:~      In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA~     class) 2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator~     (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular~     outward clinic visits. The number of relevant arrhythmia's detected will count for the~     primary endpoint. Also the number of medication changes and institution of OAC.~      Study population:~      50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT~     implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.~      Primary study parameters/outcome of the study:~      Primary endpoints~        -  AF burden and AF episodes detected~        -  Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias~          (VT's) or bradycardias~        -  % patients on OAC after 1 year follow-up~        -  Number of clinically relevant patient activated events~        -  Number of treatment policy changes based on the Reveal XT~      Secondary study parameters/outcome of the study~        -  specificity of AF detection algorithm by the Reveal~        -  Predictive value of the cardiac Compass data to predict worsening heart failure~          episodes.~   "
129019|NCT01366690|"~     The provision of HIV care and prevention services in resource-limited settings (RLS) entails~     substantial challenges due to a human resource crisis.[1] One strategy to address this human~     resource crisis is task shifting—the redistribution of tasks from higher trained providers~     to health workers with less training. Peer supporters, a group of community health workers~     who are people living with HIV (PLHIV), are an underutilized cadre to whom tasks can be~     shifted. Peers have been used extensively and effectively in HIV/AIDS programs in RLS,~     typically as peer educators who provide HIV prevention and education services.[2] Peers may~     be a potential source for not only providing care, but also impacting patient behaviors~     through peer counseling, education, and psychosocial support.~      With the scale up of HIV counseling and testing in RLS, increasing numbers of PLHIV know~     their serostatus and could potentially be engaged in care and prevention services. While~     antiretroviral therapy (ART) is a critical component of care which has been a source of much~     attention, PLHIV who are not yet on ART can also benefit from being engaged in care and~     utilizing other evidence-based health interventions besides ART. Also, many HIV/AIDS care~     programs have difficulty both retaining PLHIV in care prior to ART and initiating ART in a~     timely fashion. Additionally, many PLHIV not yet on ART still engage in risky sexual~     behaviors and do not fully utilize a proven basic preventive care package (BCP) set of~     interventions (cotrimoxazole prophylaxis, bed nets, and safe water systems). Peers may be~     able to impact PLHIV not yet on ART by improving linkages to care, facilitating timely~     initiation of preventive interventions and ART, and decreasing risky sexual behaviors.~     However, well-designed and evaluated operations research is needed to assess peer support~     effects on these care and behavioral outcomes.~      The objective of this study is to assess the impact of a peer support home visit~     intervention on patient engagement in care, utilization of a basic care package (BCP) of~     preventive care interventions, and risky sexual behaviors among people living with HIV~     (PLHIV) not on antiretroviral therapy (ART) through an individually randomized, operations~     research, community-based trial. We will compare outcomes between PLHIV who receive the~     peer-led intervention to those who do not. The primary outcomes will be engagement in care,~     BCP adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive~     the peer intervention will have improved engagement in care compared to PLHIV not receiving~     the intervention; (2) PLHIV who receive the peer intervention are more likely to adhere to a~     BCP of interventions to prevent illness compared to PLHIV not receiving the intervention;~     (3) PLHIV who receive the peer intervention will have less risky sexual behaviors compared~     to PLHIV not receiving the intervention.~   "
129020|NCT01366677|"~     This study aims to provide novel information on the feasibility of yoga interventions for~     secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood~     states, fall risk and balance. This information will be important for determining safe,~     cost-effective and reliable practices for the benefits of yoga as an alternative means for~     improved health and well-being. A yoga intervention that is integrative and evidence-based~     will benefit the blind population through effective treatments and prevention of secondary~     symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in~     the future.~   "
129021|NCT01366664|"~     The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug~     has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60~     mg when concomitantly administered in participants taking terazosin.~   "
129022|NCT01366651|"~     The purpose of this study is to characterize the penetration of doripenem in the cerebral~     spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented~     or suspected infection and are planning to, or undergoing treatment with intravenous (IV)~     antibiotics.~   "
129023|NCT01366638|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus~     (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser~     or non-responder to Interferon-based therapy) in Japan.~   "
129024|NCT01366625|"~     The purpose of this study is to investigate the clinical utility of renal denervation for~     the treatment of resistant hypertension coexisting with obstructive sleep apnea.~   "
129025|NCT01366612|"~     This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan~     and low dose total body irradiation in patients undergoing allogeneic stem cell~     transplantation. A study population of 80 subjects will be enrolled from The John Theurer~     Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive~     allogeneic hematopoietic stem cell transplantation according to the eligibility criteria~     will be consented and enrolled. Subjects will be randomly assigned to receive one of 2~     conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total~     body irradiation (TBI). Subjects will be followed until 1 year post transplantation to~     assess the relapse rate in each arm and transplant-related toxicity.~      The combination of fludarabine and busulfan is the current standard of care for patients~     with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS)~     undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a~     randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.~   "
129026|NCT01366599|"~     Describe cardiovascular events in a cancer population receiving highly emetogenic~     chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).~   "
129027|NCT01366586|"~     The study aims to:~        1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using~          confocal laser endomicroscopy.~        2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo~          immunohistochemistry .~   "
129028|NCT01366573|"~     The aim of the study is to assess the safety and tolerability of GSK1521498 in combination~     with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you~     have been given these together. The study will also determine whether GSK1521498 will have~     an effect on alcohol liking and consumption.~   "
129029|NCT01366560|"~     GSK962040 is a selective non-peptide motilin receptor agonist which is in development for~     the treatment of conditions associated with slow rates of gastric emptying. Single ascending~     doses (1 to 150 mg), and 14-days repeated doses (10 to 125 mg daily) have been investigated~     in two randomized, placebo-controlled trials. Results show that these doses were well~     tolerated with few mild to moderate adverse events (AE), and no clinically significant~     abnormal vital sign measurements, ECG changes or abnormal clinical laboratory findings.~     GSK962040 exhibited predictable PK with and without food. The mean within subject time for~     half a [13C]-containing meal to empty from the stomach (GE t½) decreased by 22-43% from~     placebo with GSK962040 50-150 mg single doses, and shortening of gastric emptying was~     confirmed at doses of 50 mg and above in the repeat dose study.~      Several studies have shown that motilin agonists increase lower oesophageal sphincter (LOS)~     pressure and have various dose dependent effects on oesophageal peristaltic amplitudes and~     propulsive contractions in both healthy volunteers and patients with gastro-oesophageal~     reflux disease (GORD). The purpose of the present study is to examine the effect of~     GSK962040 on oesophageal function, using techniques such as high resolution oesophageal~     manometry, and pH/gastric transit using a wireless motility capsule.~   "
129030|NCT01366547|"~     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in~     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations~     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of~     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first~     line regimen due in large part to its convenient presentation as a full treatment regimen in~     a single product, other options are needed. A fixed-dose combination of DTG/abacavir~     (ABC)/lamivudine (3TC) is one such opportunity.~      This is a single-center, randomized, open-label, 3-period crossover study in healthy adult~     subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG~     50 mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the~     separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in~     the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6~     different treatment sequences. There will be a screening visit within 30 days prior to the~     first dose of study drug and a follow up visit within 7-14 days after the last dose. There~     will be a 7 day washout between doses in each treatment period.~      The following PK parameters for DTG, ABC and 3TC will be measured: area under the~     concentration curve from time zero (pre-dose) extrapolated to infinite time~     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the~     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration~     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of~     Cmax (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F)~     and apparent terminal phase volume of distribution (Vz/F).~   "
129031|NCT01366534|"~     This study will evaluate whether administration of two investigational malaria vaccines~     (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection~     against malaria infection as compared to protection induced by the 257049 vaccine alone. The~     study will also evaluate the safety and the immune response to the new combination of the~     two experimental malaria vaccines.~   "
129032|NCT01366521|"~     A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients~     with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of~     mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety,~     pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as~     safety/tolerability assessments will be collected throughout the study~   "
129033|NCT01366508|"~     GSK is planning to undertake two anti-obesity drug studies in the area of obesity. In~     addition to assessment by questionnaires, it would be of significant value to incorporate an~     objective non-interventional measure of cognitive or motivational processing associated with~     evaluating and responding to food stimuli. Obesity is associated with increased attentional~     bias to palatable foods. The aims of this protocol are two-fold, first to characterize Event~     Related Potentials (ERPs) of two common aspects of food stimuli relevant to eating disorders~     -presence of food and its palatability, and secondly, to assess the modulation of these ERPs~     by appetite. Following a successful completion of this study, it is the intention to use the~     paradigm developed in future studies in the area of obesity.~   "
129034|NCT01366495|"~     The investigators propose to conduct both a randomized trial of HIV testing in community~     corrections, and a randomized trial of linkage to HIV care for people with HIV recruited~     through community corrections (probation and parole).~   "
129035|NCT01366482|"~     The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating~     the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by~     treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon~     catheter alone in patients with peripheral arterial disease.~   "
129036|NCT01366469|"~     The primary objective of this pilot study is to identify and quantify inflammatory and~     genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a~     history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary~     revascularization (CABG) to determine the risk of developing post operative respiratory~     failure. To achieve this objective, this proposal outlines the following specific aims:~      Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in~     patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at~     the time of intubation immediately prior to surgery and again upon skin closure immediately~     after the surgical procedure.~      Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with~     post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24~     hours), pneumonia, and/or tracheostomy.~      Aim #3. To inform the development and implementation of a large pivotal trial which may~     impact clinical decision-making during the initial pre-operative outpatient assessment of~     COPD patients undergoing CABG.~   "
129037|NCT01366456|"~     The purpose of this study is to evaluate efficacy of Shingigu and Charcoal moxibustion~     scientifically and objectively.~   "
129038|NCT01366443|"~     Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately~     diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied~     in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional~     method.~   "
129039|NCT01366430|"~     The purpose of this study was to compare the immediate efficacies of each treatment~     maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo~     (HC-BPPV).~   "
129040|NCT01366417|"~     The primary objective of this study is to measure the antimicrobial effectiveness of~     ChloraPrep One-Step Frepp Applicator.~   "
129041|NCT01366404|"~     About 10,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for~     the natural history of coronary lesions at 2 year clinical and imaging follow-up.~   "
129042|NCT01366391|"~     Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2~     Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome,~     gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary~     syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation.~     In every day medical practice lower doses of Metformin are administered searching for the~     continuation of the treatment.~      However, there is no clinical study to support this assertion. The objective of this study~     is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking~     daily doses of 1500mg and 1000mg.~   "
129043|NCT01366378|"~     This open-label study assesses the single-dose pharmacokinetics of~     intravenously-administered MNTX in healthy adult male and female subjects in the absence of,~     and in the presence of, orally-administered cimetidine.~   "
129044|NCT01366365|"~     This double-blind, randomized, two-cohort, placebo-controlled, parallel group study~     characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses~     and at steady-state during multiple dosing and assessed the effects of aging on the~     pharmacokinetics, safety and tolerability of MNTX.~   "
129045|NCT01366352|"~     This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal,~     healthy volunteers. Study treatment entailed single doses of two different formulations of~     MNTX tablets.~   "
129046|NCT01366339|"~     This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy~     volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of~     each active treatment group is further randomized to a second, replicate dose of MNTX, and~     the placebo group receives an additional placebo dose.~   "
129047|NCT01366326|"~     MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to~     evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC)~     injection for a period of seven days. Blood samples will be obtained at screening and for~     drug concentration data.~   "
129048|NCT01366313|"~     The aim of our study is to define the median effective analgesic doses (ED50) of~     paracetamol, morphine, and their combination and determination the nature of their~     interaction administered IV for postoperative pain after moderate painful surgery using~     up-and-down and isobolographic methods.~   "
129049|NCT01366300|"~     The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine~     infusion initiated and maintained during surgery, on propofol requirements during general~     anesthesia.~   "
129050|NCT01366287|"~     The primary purpose of this study is to estimate the relative bioavailability and food~     effect of a PF-03882845 tablet as compared to a suspension formulation used in previous~     clinical studies.~   "
129051|NCT01366274|"~     This single-blinded randomized study aims to compare two methods of manual hyperinflation~     (protective - moderate tidal volumes with positive end expiratory pressure) and~     non-protective (large tidal volume and no positive end expiratory pressure) in ventilated~     acute trauma patients, to investigate the effect on inflammatory markers, lung compliance,~     oxygenation and sputum volume.~   "
129052|NCT01366261|"~     The purpose of our study was to compare the size and the quality of biopsy samples together~     with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in~     prospective, randomized fashion. The second aim was to compare safety and tolerability of~     both types of procedure, performed in local anesthesia with addition of intravenous sedation~     and analgesia.~   "
129053|NCT01366248|"~     This NIH-NCCAM funded epidemiologic research is being conducted as an observational~     prospective case-control study of the use of Complementary and Alternative Medicine (CAM)~     and Integrated Oncology (IO) and their effects on breast cancer patients in community~     settings.~      Hypothesis: IO services improve patients' quality of life and decrease cancer recurrence~     rates in breast cancer patients as compared to women with similar disease states and~     prognoses who do not receive IO care, and may or may not use CAM treatment on their own.~   "
129054|NCT01366235|"~     Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic~     differences of therapeutic effect of chloroquine and search the cause of these ethnic~     differences. For this purpose, chloroquine will be administered to four ethic groups of~     Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will~     be measured. The result of this study will be helpful in finding more adequate dosing~     regimen of chloroquine in patients with malaria.~   "
129055|NCT01366222|"~     The purpose of this study is to determine whether food concentrates supplementation~     (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma~     symptoms and lung function in children due to asthma.~   "
129056|NCT01366209|"~     PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the~     Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study~     objectives are to confirm the treatment effect of pirfenidone compared with placebo on~     change in percent predicted forced vital capacity (%FVC) in patients with idiopathic~     pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared~     with placebo in patients with IPF.~   "
129057|NCT01366196|"~     Acute pain management is challenging in patients after spinal fusions, particularly since~     most have taken analgesics for prolonged periods before choosing the surgical alternative.~     Many of these patients are either preoperatively or become after surgery narcotic dependent.~     In addition, the narcotic based anesthetic required for the procedure, may induce a~     postoperative hyper-analgesia which may be partially responsible for the acute postoperative~     pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive~     and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is~     mediated via non-conventional neural pathways. It is for these reasons, that in these~     patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this~     situation is best managed using a multimodal approach. This technique allows the application~     of a number of treatment modalities which maximize pain reduction and minimize treatment~     side effects.~      Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain.~     Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid~     consistent absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug~     interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain~     regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly~     to conventional narcotic analgesics after surgery.~      Hypothesis: Patients treated with Pregabalin after posterior-spinal fusions will have: 1)~     reduced pain at rest and with physical therapy, and 2) reduced narcotic requirements with~     fewer narcotic related side-effects than controls treated with Pregabalin. This may result~     in a shorter hospital stay (the mean length of stay for 1-2 level posterior lumbar-sacral~     fusions with instrumentation at our institution is 4.9±2 days).~   "
129058|NCT01366183|"~     This trial studies the chemotherapy toxicity on quality of life in older patients with stage~     I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or~     fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may~     help doctors plan better ways to treat cancer.~   "
129059|NCT01366170|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. it may also help doctors~     predict how patients will respond to treatment.~      PURPOSE: This research trial studies biomarker expression in tissue samples from young~     patients with anaplastic large cell lymphoma.~   "
129060|NCT01366157|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about changes that occur in DNA and identify biomarkers~     related to cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research trial is studying protein biomarker levels in tissue samples from~     young patients with low-risk Hodgkin lymphoma.~   "
129061|NCT01366144|"~     This phase I trial studies the side effects and the best dose of veliparib when given~     together with paclitaxel and carboplatin in treating patients with solid tumors that are~     metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the~     growth of tumor cells either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may~     kill more tumor cells.~   "
129062|NCT01366131|"~     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed~     to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin +~     bevacizumab therapy in patients with histologically or cytologically documented inoperable,~     locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.~   "
129063|NCT01366118|"~     The parameter that best correlates with 5 years disease-free survival (DFS ) in patients~     (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after~     chemo-radiotherapy (Ch-RT). DFS is 97% in pts with ypT0N0M0 = ypCR and 42% in pts with ypN~     +. Standard 5-FU Ch-RT achieves 15% of ypCR. The use of IMRT achieves a high proportion of~     ypCR . This study aimed to demonstrate in a prospective manner the feasibility of~     personalizing Ch regimen base in TT in combination with IMRT in patients with RC. Secondary~     objectives included the number of ypCR and safety.~   "
129064|NCT01366105|"~     In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid~     in wound healing along the lines of closure for lower extremity amputation and complex~     abdominal wounds. This study is designed to be a prospective, randomized clinical trial to~     evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these~     wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs.~     standard dressing) prior to surgery, and will be followed in the post operative period to~     monitor the effects on their surgical closures. The experimental group will consist of~     participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.)~     device placed intra-op along the line of closure. The control group will receive a standard~     surgical dry sterile dressing. The surgical closures will be assessed after three days of~     treatment as well as the first outpatient post-op visit and any subsequent visits through~     the following 6 months. By doing so, the investigators hope to demonstrate the utility of~     NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a~     difference in clinical outcome of incisions treated by NPWT over our current standard~     technique.~      All patients in the principal and co-investigators practice who are scheduled to undergo~     lower extremity amputation or complex abdominal closure will be eligible for enrollment in~     this prospective randomized study. There are no exclusion criteria. Informed consent will be~     obtained pre-operatively. Data collection will include basic demographic data, disease~     history, past medical and social history as well key data relating to wound healing~     (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative~     complications). The investigators will use simple statistical methods (ANOVA and chi-squared~     analysis) to compare surgical wound healing between the two populations. The only deviation~     from current standard of care in these populations includes utilizing a V.A.C. system on the~     closure line of the experimental group versus the standard dry sterile dressing.~   "
129065|NCT01366092|"~     Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord~     blood transplant. The donor's immune system may recognize the your body (the host) as~     foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It~     is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system~     from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be~     used in combination with steroids to treat cGVHD.~   "
129066|NCT01366079|"~     There was an only single operator study reporting dynamic position change during colonoscopy~     withdrawal significantly improved polyp and adenoma detection. So we designed a prospective,~     randomized multicenter study to verify the effect of dynamic position change in colonic~     adenoma detection. We think position change improve luminal distension and has the potential~     to improve adenoma detection rate.~   "
129067|NCT01366066|"~     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in~     pressure was observed in the external urethral sphincter along with an increase in bladder~     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve~     Stimulation (TMNS) in women could induce pressure increment of the external urethral~     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33~     women suffering from urinary stress incontinence were able to contract their pelvic floor~     muscles and had become free of symptoms. Another pilot study has shown promising effect on~     the overactive bladder syndrome.~      The present study aims to treat urinary incontinence and includes 2 groups of patients with~     30 patients in each group: Women suffering from urinary stress incontinence and women~     suffering from urge incontinence. A medical vibrator is used and in each group the subjects~     will be randomized to vibration treatment or no vibration treatment. All patients will~     receive pelvic floor training and all women suffering from urge incontinence will receive~     anticholinergic medications.~      The stimulation will be performed at the perineum every day for 6 weeks with an amplitude of~     2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires,~     micturition diaries and diaper tests.~      If the investigators are able to demonstrate a significant reduction in the incontinence~     symptoms in the subjects the investigators asses that vibration can be a way of~     reestablishing a normal function of the pelvic floor muscles and bladder function in~     incontinent patients.~   "
129068|NCT01366053|"~     This Phase IV observational trial is intended to identify patients who are failing GnRH~     agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary~     manoeuvres involving antiandrogens. This group may include both non-metastatic as well as~     metastatic patients. The trial will determine if these patients will benefit from switching~     to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen~     levels and whether continuous use of Degarelix improves disease progression.~      As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains~     active in most patients who have developed castration resistant disease, it is recommended~     that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue~     patients on Degarelix throughout the castrate resistant period. This will allow for the~     gathering of data that is currently unknown within this setting, such as the effect of~     combined treatment with antiandrogens as well as chemotherapy and other castrate resistant~     treatments.~   "
129069|NCT01366040|"~     This is an open-label, multicenter, survey-based study to determine subject satisfaction~     with using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will~     consist of 200 subjects in a single cohort who have been prescribed AVONEX PEN in accord~     with its Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it~     for at least 12 weeks without any support person to help with the injections administered in~     the vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The~     clinic nurse investigator will instruct the patient on the correct method of using AVONEX~     PEN and the first injection with Autoinjector, using the subject's own supply, will be~     completed in the clinic, with the clinic nurse investigator present. All further injections~     of AVONEX PEN will be self-administered at home. The subjects will complete the first set of~     questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and~     the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at~     the clinic, and will be given another set of questionnaires to be completed at home within~     10 minutes following the last study injection 2 months later, provided the subjects still~     continue to self-administer their AVONEX PEN. The first set of questionnaires will be left~     with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second~     set will need to be mailed to the CRO by study subjects using the provided self-addressed,~     postage-paid envelope.~   "
129070|NCT01366027|"~     PBA is a neurologic condition that is estimated to impact over a million patients and their~     families in the United States. PBA occurs secondary to an otherwise unrelated neurologic~     disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of~     crying and/or laughing. Progress has been made in better understanding this debilitating~     condition, but much more needs to be done. That's why a new PBA patient registry, PRISM~     (Pseudobulbar Affect RegIstry Series), has been initiated.~      The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in~     patients with underlying neurologic conditions including~        -  Alzheimer's disease~        -  Amyotrophic lateral sclerosis~        -  Multiple sclerosis~        -  Parkinson's disease~        -  Stroke~        -  Traumatic brain injury~      Because this is an observational registry, it doesn't require you to intervene with any~     specific treatment or procedure. Your participation allows the PRISM registry to collect and~     analyze data from your site and also compare it to national numbers captured in the PRISM~     registry about PBA across all of the major at-risk neurologic populations.~   "
129071|NCT01366014|"~     This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability~     of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe~     pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety.~     Approximately 150 patients from the US will be enrolled in this study.~   "
129072|NCT01366001|"~     The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when~     administered to opioid-experienced cocaine abusers.~   "
129094|NCT01365715|"~     The main purpose of this study is to assess the efficacy of preoperative embolization in~     decreasing operative blood loss, decreasing the need for intraoperative transfusion and~     facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at~     describing the vascularity in a series of spinal metastasis, and to correlate this with~     perioperative blood loss.~   "
129095|NCT01365702|"~     The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow~     obstruction due to Tuberculosis (TB) destroyed lung.~   "
131012|NCT01340586|"~     The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg~     Apixaban in subjects with normal renal function and subjects with end stage renal disease~     (ESRD) maintained with hemodialysis.~   "
129073|NCT01365988|"~     Objective- To use fMRI to compare brain activity at rest and during memory and decision~     making tasks in normal children and in children exposed in utero to drugs of abuse.~      Study population- All participants will be 14-20 year-olds enrolled in an ongoing~     longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A~     subgroup of this study cohort will be invited to participate based on added criteria needed~     for scanning studies, such as absence of metal in the body, no significant CNS disease, and~     ability to tolerate the scanning environment.~      Design- Participants will undergo fMRI scans while performing a memory task, a decision~     making task and at rest. Data from participants in the current study may be combined with~     those from a previous study (NIDA protocol 417) which now reside in our repository protocol,~     8002 and NIDA protocol 455.~      Outcome measures- The primary outcome measures will be the difference in BOLD fMRI~     activation between drug-exposed participants and those without prenatal exposure to drugs of~     abuse.~   "
129074|NCT01365975|"~     Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects~     (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate~     levels during pregnancy, and/or certain variants in the gene that encodes~     methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of~     5-methyltetrahydrofolate [the primary methyl donor in most metabolic pathways involving~     methylation including DNA methylation] from 5,10 methylenetetrahydrofolate may be associated~     with reduced risks of certain adverse events during the prenatal period, birth weight and~     certain serious diseases in offspring, while other studies have raised concerns about~     increased risks of specific serious disorders. Only one study has examined late health~     effects in mothers that might be associated with use of periconceptional folic acid~     supplements.~      We propose to study potential health benefits and adverse effects of periconceptional folic~     acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will~     evaluate whether periconceptional folic acid supplements reduced risk of external congenital~     birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or~     increased for other pediatric disorders linked with periconceptional folic acid supplements~     including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood~     pressure. In the mothers, we will assess cardiovascular diseases and associated risk~     factors, breast and colorectal cancers and precursor conditions, and other cancers. We will~     also conduct exploratory assessment of other serious diseases in mothers.~      To increase the limited data on the morbidity and survival of children born with a major~     birth defect, particularly in low- or middle-income countries, we plan to assess morbidity~     and mortality outcomes in children identified with neural tube defects as part of our~     follow-up.~      The women and children who participated in the joint China-U.S. Community Intervention~     Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the~     periconceptional period and their offspring) represent unique cohorts whose periconceptional~     exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP~     mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status,~     medical history, and lifestyle habits. The study will clarify whether there are differences~     with respect to growth, physical development during the puberty period, selected serious~     morbidity and mortality in offspring and risks of serious health outcomes and mortality in~     mothers associated with periconceptional folic acid supplements. Data from this study will~     inform us about cohort participation rate, cost, and effective approaches for future~     follow-up of the full cohort.~      The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out~     two specific aims in 500 families. We will test and evaluate the most effective approaches~     to trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and~     children. If the child is not living with the biological mother, we will trace the caretaker~     or next of kin with whom the child is living. We will also conduct in-person interviews,~     obtain anthropometric and blood pressure measurements and determine cohort participation~     rate in a sample of 500 CIP families from two of the 21 CIP project counties to obtain~     health information, medical history, and vital status. We will attempt to enroll in the~     pilot study 500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500).~     Excluded from the Pilot Study #1 at this time are the families in which the mother or the~     child is deceased. We will seek permission from the IRB to enroll these families at a later~     date.~   "
129075|NCT01365962|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with~     rhabdomyosarcoma.~   "
129076|NCT01365949|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing~     sarcoma.~   "
129077|NCT01365936|"~     There have been some controversies regarding the use of preparations with LH activity in~     patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this~     research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect~     to the prevention of OHSS~   "
129078|NCT01365923|"~     During recovery from general anesthesia the stimuli of endotracheal tube lead to the~     coughing, hypertension, tachycardia, which can cause a serious complication. Especially the~     postoperative course of patients emerging from general anesthesia after intracranial surgery~     is frequently complicated by the occurrence of hypertension and coughing event.~      It has been demonstrated that opioid, intravenous or topical lidocaine administration can~     attenuate the coughing reflex. Administered the opioid before emergence, it is effective to~     prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.~      However, remifentanil is an opioid widely used because of rapid context-sensitive half-life,~     target-controled infusion method to adequately maintain the effect site concentration could~     help to predict the recovery time to the alert state from the general anesthesia. It is~     considered proper method of continuous infusion of remifentanil for reducing emergence~     cough.~      Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces~     arterial blood pressure and heart rate, decreases the hemodynamic and and catecholamine~     response to intubation and extubation. It is thus theologically appropriate for reducing~     airway and circulatory reflexes during emergence from anesthesia.~      In this study, the investigators used bolus dexmedetomidine immediately before extubation,~     and compared the effects on coughing, hemodynamic response and recovery profile to a~     continuous infusion of remifentanil.~   "
129079|NCT01365910|"~     This phase II trial studies how well Linifanib works in treating patients with advanced,~     refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
129080|NCT01365897|"~     The purpose of this study is to determine whether modafinil is effective in the improvement~     of mnesic performance and executive functions of university students from high academic~     performance.~   "
129081|NCT01365884|"~     Proof of concept study to compare the best corrected visual acuity obtained via First-Sight~     lenses with the autorefraction in children.~   "
129082|NCT01365871|"~     The current standard for pain relief during prostate biopsy is the injection of local~     anesthetic agents into or around the prostate at various sites including apex, base, lateral~     aspects and into the prostate itself. Despite such anesthetic injection, some men still~     experience severe pain and often at the base of the penis. The study audits current~     practices comparing the degree of pain relief provided by injection at basal versus~     basal+apical sites. All these injection sites are standard practice at our hospital.~   "
129083|NCT01365858|"~     -  Background : The general experience with the Virtual Reality application approach~          suggests that this treatment concept is promising in stroke rehabilitation~        -  Purpose : In shopping activity in a real supermarket and in simulated with the~          investigators virtual shopping simulation (VAP-S = virtual action planning~          supermarket), the investigators will compare people who had undergone a stroke who~          receive conventional rehabilitation or virtual training in VAP-S.~   "
129084|NCT01365845|"~     The purpose of this study is to determine if proton radiation therapy will reduce the amount~     of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of~     any cardiac side effects.~   "
129085|NCT01365832|"~     C-reactive protein (CRP) is directly implicated in atherogenesis and associated~     cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective~     Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease~     CRP levels and thus consequently improve disease-related cardiovascular morbidity. However,~     the influence of gender on the CRP evolution pattern has never been assessed before. The aim~     of our study was to investigate possible gender differences in CRP evolution in OSA patients~     3 and 6 months after the start of effective CPAP treatment.~   "
129116|NCT01365507|"~     This trial is conducted in Asia and North America. The aim of this trial is to compare the~     efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve~     subjects with type 2 diabetes mellitus when using two different titration algorithms (dose~     individually adjusted) as add-on to subject's ongoing treatment with metformin.~   "
129117|NCT01365494|"~     This study was planned to establish the non-inferiority of Rabipur administered as simulated~     post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult~     subjects.~   "
129118|NCT01365481|"~     The purpose of this study is to assess the long-term safety and tolerability profile of~     valsartan and valsartan-based treatments in children with hypertension, with or without~     chronic kidney disease.~   "
129086|NCT01365819|"~     Methamphetamine (MA) dependence is a source of continuing danger for both individuals and~     society. While there are some behavioral treatments, they are not always effective. To date,~     there are no medications available to treatment methamphetamine dependence. There is some~     early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to~     stop or reduce their use of methamphetamine. Varenicline is already on the market in the~     U.S. for cigarette smoking cessation and shows promise for treating alcohol dependence. In~     order to determine if varenicline can help people stop using methamphetamine, we will enroll~     90 methamphetamine-dependent people who are looking for treatment into the study at the UCLA~     Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and~     half will receive placebo (n=45) which will be determined randomly. Everyone will receive~     talk therapy for methamphetamine dependence. People will take the medication for 9 weeks~     followed by a 4 week follow-up period. Before receiving any medication, participants will~     complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,~     psychological and medical evaluation, and comprehensive assessment of drug use to determine~     study eligibility. If a person is eligible for the study, s/he will receive either~     varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three~     times a week study visits. At the end of the medication phase, subjects will complete a four~     week follow up period for safety monitoring.~   "
129087|NCT01365806|"~     The long-term goal of this research is to apply novel technology for detection of donor~     organ (allograft) rejection to improve patient outcomes following heart transplantation. The~     specific goal of this study is to determine whether daily monitoring of the transplant~     recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG~     Core Laboratory would provide an early biomarker for acute rejection. Despite routine~     immunosuppressant drug therapy, acute rejection is common, especially within the first 6~     months following transplant surgery. To detect rejection, frequent endomyocardial biopsies~     of heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure~     performed in a hospital cardiac catheterization laboratory that has associated risks. Recent~     evidence suggests that acute allograft rejection causes delays in ventricular repolarization~     resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1)~     determine whether an increase in the QT interval during the first 6 months following heart~     transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the~     timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe~     rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection~     that could be measured at home is that it might yield earlier detection of rejection, allow~     more timely therapy and reduce mortality from acute allograft rejection.~   "
129088|NCT01365793|"~     The investigators will conduct a randomized controlled trial comparing four different~     intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two~     rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of~     these two basic rehydration protocols, the investigators will vary the type of rehydration~     fluid used (0.9% saline or 0.45% saline). The investigators will compare the different~     treatments by conducting assessments of neurological injury, by measuring the frequency of~     significant cerebral edema, and by measuring long-term neurocognitive function.~      These studies will allow us to determine whether variations in IV fluid treatment protocols~     affect acute neurological outcomes of DKA. Additionally, they will provide important data~     regarding the impact of DKA and DKA treatment on long-term neurocognitive function in~     children. In this way, the investigators hope to identify a more ideal fluid management~     strategy for children with DKA.~      Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and~     that brain injury might result from this reduction in blood flow and/or the effects of~     re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The~     investigators hypothesize that more rapidly re-establishing normal blood flow to the brain~     during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt)~     content, will help to minimize brain injury caused by DKA.~   "
129089|NCT01365780|"~     This project is meant to show wether the HBOT can fasten the recovery process after surgical~     treatment of distal Radius fractures. For this propose the microcirculation is measured,~     together with the level of pain on a visual analog scale (VAS) and the remaining force of~     the hand after surgery is examined. Furthermore the sonography with contrast medium which is~     long established for examination of organs of the parenchyma, is meant to be verified at the~     muscular-skeletal system in this project.~   "
129090|NCT01365767|"~     The purpose of this study is to determine how relevant dynamic ultrasound scans using~     contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared~     to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.~   "
129091|NCT01365754|"~     The purpose of this study is to compare posterior dynamic stabilization with fusion in the~     treatment of lumbar degenerative disease.~   "
129092|NCT01365741|"~     The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient,~     a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.~      The study aims to mimic the treatment Danish patients receive when admitted to the hospital~     with a ST-elevation myocardial infarction since these patients are refereed to acute~     Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic~     inhibition.~      Current guidelines recommend the administration of Efient right before the PCI procedure,~     while the patient is lying down, either in the ambulance or in the operating room. We, the~     investigators, believe that this is suboptimal for the patient, since any sort of prolonged~     inhibition time will possibly worsen the patients prognosis and make the patient more prone~     to later clotting issues.~      Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright~     position and making them sit up for 2 minutes after ingestion, the effect of the pills will~     commence faster than if taken in a supine position. This will possibly lead to faster~     inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting~     issues during and after the procedure.~   "
129093|NCT01365728|"~     The purpose of the study is to compare the results of LASIK surgery when using two versions~     of a femtosecond laser in patients with nearsightedness with and without astigmatism.~   "
131017|NCT01340521|"~     The goal of the study is to quantitatively evaluate pituitary hormone response, follicle~     stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate~     in normally fertile women.~   "
129096|NCT01364636|"~     Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF~     patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a~     prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury~     released in 2 hours, and addressed in several different clinical scenarios(contrast injury,~     cardiopulmonary bypass, critical illness.~      Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).~      Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL~     to predict the development of CRS type 1 in patients admitted to the Emergency Room.~      Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse~     outcomes (length of hospitalization, death, institution of renal replacement therapy, use of~     vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in~     adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of~     renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF~     that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the~     association of drugs commonly used for HF management, which might influence the evolutionary~     behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision~     making.~      Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted~     to the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal~     Fluminense.~      Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis;~     Predictive performance of the cut-off: sensibility, specificity, likelihood ratio,~     predictive value, accuracy; Identification of variables to predict CRS: logistic regression~     and square-Qui test; Correlations analysis of normally distributed variables: Pearson's~     linear correlation test; Mean values for normally distributed variables: Mann-Wittney test;~     Significance on p<0,05; Intra-assay variation analysis.~      Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days;~     Manuscript preparation for paper submission: 30 days.~   "
129097|NCT01364623|"~     The purpose of this study is to assess the bioavailability of total testosterone through~     pharmacokinetic profiles obtained following (a) single administration of three doses of~     TBS-2 b) multiple administration TBS-2.~      In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG~     and estradiol through pharmacokinetic profiles will also be conducted.~   "
129098|NCT01364610|"~     Gastroesophageal reflux disease (GERD) is a common and potentially debilitating disorder.~     Typical symptoms include heartburn and regurgitation of acid tasting substances. GERD is a~     chronic disease and in some cases, more alarming symptoms including food sticking in the~     esophagus, pain with swallowing, bleeding, anemia and weight loss develop.~      In Alberta, upper endoscopy is the first line of investigation accompanied by an ambulatory~     24-hour esophageal pH monitoring for patients with symptoms that are unresponsive to~     acid-suppressing therapy or who exhibit alarm symptoms.~      Current standard of care in Alberta for esophageal pH monitoring first requires an~     esophageal manometry test to identify the location of the lower esophageal sphincter~     followed by the placement of a thin catheter with one or more pH probes inserted through the~     nose and taped in place to the face for 20 -24 hours. The patient wears a small battery~     powered data logger and maintains a diary of GERD symptoms and activity. This system enables~     the recording and correlation of specific symptoms with reflux episodes over extended~     periods and provides direct evidence of GERD. The nasally passed pH catheter is~     uncomfortable and restrictive for some patients often resulting in abnormal eating,~     drinking, activity and sleeping patterns. The data collected may not be representative of~     the patient's typical experience and may not reflect the true severity of the disease.~      A wireless diagnostic pH monitoring system called Bravo pH Monitoring System developed by~     Medtronic is approved for use in Canada and is commercially available. This system~     eliminates the need for a catheter by utilizing a capsule the size of a gel-cap and radio~     frequency technology to monitor esophageal pH. It has been shown to be safe and as sensitive~     as conventional catheter-based pH probe monitoring. The Bravo system can be sited either~     endoscopically or manometrically.~      The goal of this study is to test the Bravo Wireless pH system in Alberta using manometric~     siting to assess feasibility, patient outcomes and tolerance.~      Hypotheses:~        1. Patient tolerance of the Bravo system is superior to standard pH-metry.~        2. Manometric placement of Bravo is as successful as standard pH-metry.~      Our aims:~        1. To assess patient tolerance of Bravo versus standard pH-metry.~        2. To compare the success rate of manometric peroral placement of Bravo pH probe versus~          standard pH-metry.~   "
129099|NCT01364597|"~     This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects~     with epilepsy.~   "
129100|NCT01364584|"~     Previous research in our lab and others has established that type 2 diabetes (T2D) is~     associated with significantly impaired functional exercise capacity, a factor which is~     potentially associated with an increased risk of cardiovascular disease in those with type 2~     diabetes. Of great concern, the majority of people with type 2 diabetes are sedentary and~     one possible reason may be that exercise, even at low levels, is perceived as being a harder~     effort than for nondiabetic people. Thus, treatments that may motivate patients with type 2~     diabetes to be more physically active have great potential benefit.~      Recent observational studies suggest that glucagon-like peptide-1 agents, such as exenatide,~     may have a beneficial effect on endothelial and cardiac function. Because these two factors~     have been shown to be associated with exercise dysfunction in type 2 diabetes, the~     investigators hypothesize that exenatide may improve exercise capacity in those with type 2~     diabetes. The aims of this study are to (1) assess whether exenatide will improve functional~     exercise capacity in persons with type 2 diabetes and (2) investigate the effect of~     exenatide on specific metabolic, endothelial, cardiac and peripheral circulatory measures of~     function related to changes in exercise capacity. The Investigators primary hypothesis is~     that exenatide will improve functional exercise capacity in people with type 2 diabetes.~     Having a drug that improves exercise capacity could motivate patients to exercise more and~     hence be a significant benefit.~   "
129101|NCT01364571|"~     This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of~     three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The~     main goal of the study is to determine how safe and well tolerated the vaccine is as well as~     to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65~     years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence~     of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy~     adults aged 18 to <65 years.~   "
129102|NCT01364558|"~     The purpose of this clinical research study is to assess the bioavailability and~     pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and~     injectable diazepam after intravenous (I.V.) administration~   "
129103|NCT01365676|"~     2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN®~     as antidepressant will be prescribed together for treating women with Premenstrual Syndrome~     (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE®~     prescription alone.~   "
129104|NCT01365663|"~     The purpose of this study is to study safety and tolerability of SPC4955 in healthy~     subjects.~   "
129130|NCT01365325|"~     The aim of the study is to compare two different home monitoring care programs in patients~     with chronic heart failure in functional class NYHA III, one of them based on clinical and~     electrocardiographic evaluations, the other one using also periodical handled~     echocardiographic examinations.~   "
129173|NCT01364753|"~     Our overall goal has been twofold: 1) to evaluate whether there are significant age-related~     changes in flight simulator performance near age 60, and 2) to assess whether there is an~     alternative model that can explain longitudinal flight simulator performance on the basis of~     measures of cognitive function and expertise.~   "
129105|NCT01365650|"~     This was an open label, three way study in participants with symptomatic allergic rhinitis.~     The following 3 treatments were administered to each subject during dosing periods 1, 2 and~     3, respectively:~        -  Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray~          into each nostril) on Day 1 of Period 1.~        -  Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single~          intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30~          minutes later on Day 1 of Period 2.~        -  Treatment C: Seven days of treatment with intranasal fluticasone propionate (between~          Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine~          (one 15 mg spray into each nostril) on Day 1 of Period 3.~      Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in~     each period and there was a washout period of 2 to 7 days between periods. A post study~     medical was performed within 7 days of Period 3.~      The objectives of this study were:~        -  To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~        -  To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the~          pharmacokinetics and tolerability of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~        -  To assess the effects of chronic administration of fluticasone propionate on the~          bioavailability and tolerability of intranasal ketorolac in participants with~          symptomatic allergic rhinitis.~   "
129106|NCT01365637|"~     The purpose of the study is primarily to determine the safety and toleration and~     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.~     Dosing will either be administered twice or three times daily. Secondary objectives will be~     to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on~     the PK of PF-05089771.~   "
129107|NCT01365624|"~     This study had an open-label, single-dose design. All subjects received a single dose of 30~     mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were~     obtained pre-dose and at specified time points over 24 hours post-dose.~      The primary objective of this trial was to compare the pharmacokinetics of intranasal~     ketorolac between elderly and nonelderly adult subjects. The secondary objective was to~     evaluate the safety profile of intranasal ketorolac in elderly subjects.~   "
129108|NCT01365611|"~     This was a non-randomized, open label study in healthy male and female volunteers. A single~     intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1~     and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone~     propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of~     Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7,~     and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study~     medical was performed within 7 days of study completion.~      The objective of this study was to assess the effects of chronic administration of~     fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and~     female subjects.~   "
129109|NCT01365598|"~     The purpose of this study is to evaluate the safety and efficacy of lower doses of~     primaquine compared to the dose recommended by the WHO for reducing P. falciparum~     gametocytes in the infected human host to prevent transmission of falciparum malaria to the~     anopheles mosquito vector.~   "
129110|NCT01365585|"~     The objective of this observational study is to gain clinical insight on the actual use of~     sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH).~     The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg~     three times daily for the treatment of PAH.~   "
129111|NCT01365572|"~     The purpose of this study is to evaluate the feasibility, safety, and effectiveness of~     EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis~     following drug-eluting stent (DES) implantation. The investigators will evaluate clinical,~     angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of~     EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular~     changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In~     addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM~     ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES~   "
129112|NCT01365559|"~     This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple~     Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the~     same bortezomib-containing combination regimen to which a MM patient has progressed while~     receiving. This study will enroll 45 patients total. These patients will be resistant to~     bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed~     within 12 weeks of the last dose of bortezomib in a combination regimen. Patients will be~     sub-divided into 2 groups in this study, treatments containing (Group A) or not containing~     immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and~     15 patients into Group B for a total of 45 patients. Patients must have received 4 doses of~     a minimum of 1.0 mg/m^2 of bortezomib in no more than 4 weeks per cycle. Patients must have~     received at least one cycle meeting this definition and have shown progressive disease to be~     considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the~     last dose of bortezomib in their most recent bortezomib-containing regimen that does not~     include either thalidomide or lenalidomide are eligible regardless of when patients received~     that regimen, as long as they meet the above criteria.~      Carfilzomib will subsequently replace bortezomib using the patient's most recent~     bortezomib-containing regimen to which the patient progressed while receiving. Patients will~     be eligible if they progressed from bortezomib with an alkylating agent (melphalan or~     cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or~     a glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or~     lenalidomide). The study will consist of a screening period, followed by up to eight open~     label treatment cycles, a final assessment to occur 28 days after the end of the last~     treatment cycle, a follow-up period and maintenance cycles of single agent carfilzomib.~      Patient who complete the combination treatment period without progressive disease will be~     eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy~     carfilzomib will be administered at the same dose given during the last cycle of combination~     treatment.~   "
129113|NCT01365546|"~     Proportion of surgeries in which the primary endpoint (overall assessment) is classified as~     success.~   "
129114|NCT01365533|"~     The study was a double-blind, placebo-controlled, crossover study to evaluate the efficacy~     of roflumilast on airway inflammation and function in patients with allergen-induced asthma.~      Individuals with stable, mild to moderate allergic asthma, with a history of episodic wheeze~     and shortness of breath, were eligible for enrollment.~   "
129115|NCT01365520|"~     This trial is conducted in Asia and Europe. The aim of the trial is to investigate the~     pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single~     dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A.~     Participation in this trial is dependent on previous participation in trial NN7008-3543~     (Part B) (NCT00840086).~   "
129174|NCT01364740|"~     Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep~     Apnea.~   "
129119|NCT01365468|"~     This study was to evaluate the antitumor activity and safety of RAD001 in patients with~     Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).~      The aim of the study was to :~        1. determine whether RAD001, administrated orally daily on a continuous dosing schedule~          might:~             1. Increases time to disease progression (TTP) based on volumetric MRI measurements~               in children and adults with NF1 in inoperable documented progressive PN (stratum~               1).~             2. Results in objective radiographic responses based on volumetric MRI measurements~               in children and adults with NF1 and inoperable PN in the absence of documented~               radiographic progression at the trail entry (stratum~        2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this~          patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.~   "
129120|NCT01365455|"~     This study will assess the safety and efficacy of secukinumab compared to placebo in~     patients that have moderate to severe, chronic, plaque-type psoriasis.~   "
129121|NCT01365442|"~     The purpose of this study is to provide evidence for policymakers and key opinion leaders on~     the pilot implementation of cholera vaccination using the newly licensed Oral Cholera~     Vaccine (OCV) in India. The pilot introduction will provide the evidence for the~     feasibility, costs and population acceptance of large-scale cholera vaccination using the~     Indian vaccine (using vaccination coverage rates and other measures).~   "
129122|NCT01365429|"~     Human donor lungs that do not meet the standard clinical criteria for donor lung utilization~     but fit into the study inclusion criteria will be retrieved from the donor using current~     donor lung retrieval techniques.~   "
129123|NCT01365416|"~     The prevalence of morbid obesity (BMI > 40 kg/m2) is increasing rapidly in the UK, but the~     investigators lack a coherent strategy for detailed assessment and treatment of the~     individuals affected, who are at high risk of morbidity and early mortality. The~     investigators already know that more than 1 in 20 severely-obese individuals have a simple~     genetic cause of their obesity (usually inherited in an autosomal dominant pattern.~     Bariatric surgery is the most effective treatment for morbid obesity and certain surgeries~     can result in the remission of type 2 diabetes. However, some patient fail to achieve the~     weight loss or experience complications and re-operations. The investigators are unable to~     predict the outcomes of bariatric surgery particularly in relation to type 2 diabetes~     remission which is crucial for the assessment of risk to benefit balance before wider future~     applications of the surgery.~      The investigators want to investigate the mechanism underlying Type 2 diabetes remission~     after bariatric surgery by A) examining the effect of Mendelian forms of obesity and~     diabetes on T2D remission, B) studying changes in expression profiling patterns in~     insulin-responsive tissues, C) identifying of eQTLs, and of other genetic variations~     affecting T2D remission and D) studying the role of epigenetic variation in T2D remission.~   "
129124|NCT01365403|"~     This open-label, fixed sequence, two-period study will assess the effect of multiple dose~     carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a~     single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of~     3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose~     of RO4917838 on Day 16.~   "
129125|NCT01365390|"~     The aim of this study is to provide baseline acute otitis media data in East European~     countries.~   "
129126|NCT01365377|"~     Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk~     factors are known: disease severity, age, gender. Another risk factor is lack of information~     from the medical staff and nurses.~      Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS).~     Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R)~     is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey~     (SF-36) is an assessment of life quality.~      In the following study, the investigators will evaluate the impact of a brochure as~     complement of oral information on Anxiety developed by relatives and family of ICU patients.~      The medical and surgical ICU is composed by two different units (different medical and nurse~     team, different location in the same hospital) of 12 beds on one side, 14 beds on the other~     side.~      During a year, in the first unit, the investigators will use the booklet as support and~     complement of oral information : booklet arm. The information process will be as usual in~     the other unit : control arm. During the second year, the booklet will be used in the~     second unit while the first unit will return to the usual oral information (cross-over).~      For each included patient, one relative or family member is pointed to be the referring~     family member or referent. This referent receives the HADS questionnaire at Day 3 after~     admission, at day of discharge if the patient is alive, at one month after discharge. The~     IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36~     questionnaire is given to the referent and the living patient at day 30. The day 30~     questionnaires are send by mail at the referent address.~   "
129127|NCT01365364|"~     Restless legs syndrome and periodic limb movement (PLM)are sleep-related movement disorders~     and studies have shown changes in striatal dopaminergic activity in patients with these~     disorders. Physical exercise has been shown to improve the symptoms of restless legs~     syndrome and PLM, as has treatment with dopamine agonists. However, the mechanism by which~     physical exercise acts as a non-pharmacological treatment in improving symptoms of restless~     legs syndrome and PLM remains unknown. The investigators evaluated dopamine transporter~     density profiles in 16 sedentary patients (control and experimental - with PLM, groups) and~     the influence of acute physical exercise on its concentration after a maximal exercise test.~     Each patient underwent baseline polysomnography to evaluate sleep patterns and PLM index~     values. After obtaining the polysomnography baseline, the single photon emission computer~     tomography baseline was determined. Subsequently, the volunteers performed a maximal~     exercise test in the morning, followed by a single photon emission computer tomography two~     hours later and polysomnography that night, to assess the effect of acute physical exercise~     on dopamine transporter and sleep patterns. The results showed significant lower dopamine~     transporter baseline densities in the striatum region for the experimental group. The~     results also showed a significant reduction in the periodic leg movement rate in the~     experimental group and a significant increased percentage of stage-1 non-REM sleep in both~     groups after maximal exercise test. Significant differences between the groups were only~     observed for Stage 2 sleep and slow wave sleep. Our results show that patients with PLM had~     a lower dopamine transporter density in the left putamen region compared to the control~     group and an acute physical exercise (maximal exercise test) did not alter this profile,~     providing evidence that this improvement is the result of chronic physical exercise.~   "
129128|NCT01365351|"~     The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary~     short stature in children with insufficient growth hormone production and/or short stature~     caused by Turner syndrome.~   "
129129|NCT01365338|"~     This study aims to determine whether the drug affects brain activity in healthy volunteers,~     either when the participants are performing a memory task, or when lying at rest. Subjects~     will undergo a brain scan under both of these conditions after a dose of either the study~     drug or a placebo is administered.~   "
129131|NCT01365312|"~     Appropriate delivery of adequate nutrition and medications in premature infants often~     requires central venous access in the form of a special IV called a PICC (peripherally~     inserted central catheter). While a necessary feature of neonatal intensive care, PICCs pose~     significant risk: among the most serious of these is infection. One common, successful~     infection control practice used in older children and adults involves the use of a lock, in~     which a fluid-filled syringe is attached to the end of an IV when it is not in use in order~     to prevent and/or treat clotting or infection. The solution is left for some period of time~     and is then either withdrawn from the line or flushed into the patient. The solution could~     be saline, antibiotics, other antiseptics, or any combination of these. However in the~     premature infant, use of antibiotics as a locking compound risks leaving behind organisms~     resistant to treatment; antiseptics can irritate vessels and cause breakage to sensitive~     premature skin; saline has neither sterilization nor anti-infective properties. By contrast,~     ethanol neutralizes or kills most bacteria, viruses, and fungi without the risk of~     resistance, and because it is not externally applied there is no risk to baby skin.~     Ethanol-based lock protocols have been used safely and effectively in both adult and~     pediatric populations without adverse effects, but this has not been tested in premature~     babies because fluids and medication are delivered continuously: placement of a lock~     traditionally requires an extended pause (hours or days) in fluid and medication~     administration.~      To overcome these key limitations, a periodic, brief ethanol lock protocol was designed such~     that both infant exposure and interruptions to fluid and medication delivery would be~     minimized. The lock is practical, cheap, easy to place, and takes advantage of an existing~     daily pause during which IV tubing and fluids hooked up to the PICC are changed. The~     objective of this study is to test the hypothesis that use of a 70% ethanol lock, every 3rd~     day, for 15 minutes, will safely and effectively reduce PICC infection in our unit.~   "
129132|NCT01365286|"~     The purpose of this study is to investigate heart rate lowering efficacy and respiratory~     safety of ivabradine in patients with asthma and COPD.~   "
129133|NCT01365273|"~     This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5~     centres in the US with deep-partial of full thickness burns in need of skin grafts will be~     enrolled.The subjects will be equally randomised to either treatment with Mepitel One or~     bridal veil together with staples.~      The primary objective is to compare pain at the time of dressing change for the use of~     Mepitel One versus bridal veil together with staples on deep partial or full thickness burns~     requiring skin grafts.~   "
129134|NCT01365260|"~     The purpose of this study is to determine whether MM-II is effective in the treatment of~     osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.~   "
129135|NCT01365247|"~     This treatment intervention trial is designed for men and women with substance dependence~     and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned~     to one of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and~     Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an~     active monitoring control group) and will be evaluated at baseline and four follow-up points~     (post-treatment, 1-month, 2- month and 3-month post-treatment).~   "
129136|NCT01365234|"~     Heart failure is a progressive disease that decreases the pumping action of the heart. This~     may cause a backup of fluid in the heart and may result in heart beat changes. When there~     are changes in the heart beat sometimes an implantable heart device is used to control the~     rate and rhythm of the heart beat. In certain heart failure cases, when the two lower~     chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization~     therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted)~     under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right~     and left ventricles through three leads (flexible insulated wires) that are inserted through~     the veins to the heart. The purpose of this study is to evaluate a new lead for delivering~     energy to the left ventricle (bottom left chamber of the heart).~   "
129137|NCT01365221|"~     The primary objective of this study is to compare platelet reactivity between patients~     receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients~     receiving only a loading dose of prasugrel.~   "
129138|NCT01365208|"~     The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow~     earlier and more detection of drug response in advanced NPC than RECIST method, in patients~     with previously untreated advanced NPC who will receive platinum-based chemotherapy. This~     study will also determine if this new method can predict survival in these patients. This~     study may have far-reaching impact on drug development in NPC as it may offer a more optimal~     way of evaluating drug efficacy in clinical trials and also in clinical management.~   "
129139|NCT01365195|"~     The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic~     adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management~     and on the later recovery after surgery in patients undergoing colorectal surgery.~      Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase~     the effectiveness or strength of other drugs when given at the same time.~   "
129140|NCT01365182|"~     This intervention program combines biofeedback PFME with a telephone or support group~     intervention to treat persistent urinary incontinence (UI). The study's primary aims are to~     improve continence, quality of life, and mood through enhancing adherence to PFME and~     self-management of incontinence symptoms. The secondary aims are to examine the~     physiological effects and cost effectiveness of the proposed interventions.~   "
129141|NCT01365169|"~     The goal of this study is to test the acceptability and usefulness of certain home-based~     health care devices in specific groups of cancer survivors (those who are being treated for~     head and neck or colorectal cancer, or who are current or former smokers).~   "
129142|NCT01365156|"~     The goal of this clinical research study is to learn if a surgical procedure called an~     extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation~     therapy can help to control the disease for a longer time than standard-of-care chemotherapy~     and whole pelvic radiation therapy.~   "
129143|NCT01365143|"~     To date, no study has prospectively compared open versus robotic radical prostatectomy in a~     randomized fashion for patients with prostate cancer. For patients with newly diagnosed~     prostate cancer who choose surgical management, the choice of surgical approach is often~     limited to surgeon preference and experience. This study will prospectively randomize~     patients with localized prostate cancer who are candidates for surgical management to open~     versus robotic radical prostatectomy.~   "
129144|NCT01365130|"~     The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety~     and side effects for patients with advanced gastroesophageal cancer~   "
129145|NCT01365117|"~     Phase 1 clinical trial to evaluate insulin exposure using different formulations of~     Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.~   "
129147|NCT01365091|"~     To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin,~     5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with~     saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted~     and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin~     in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and~     metformin, 1000-mg XR tablets administered together in both the fasted and fed states.~   "
129148|NCT01365078|"~     Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the~     risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or~     C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this~     conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus,~     providing oils rich in SDA may increase the endogenous synthesis of EPA. This may~     subsequently lower serum triacylglycerol concentrations, an effect frequently observed after~     EPA supplementation, especially in people with increased triacylglycerol levels.~      The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol~     concentrations in healthy overweight and slightly obese men and women. The minor objective~     is to study the effects of echium oil on the omega-3 index, which is negatively related to~     cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.~   "
129149|NCT01365065|"~     The objective of the study is to assess the safety and ability of vorinostat, a drug~     currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV~     infected CD4 T-cells.~   "
129150|NCT01365052|"~     The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and~     diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to~     placebo (capsules containing no drug) when taken for 10 days.~   "
129151|NCT01365039|"~     This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact~     lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by~     current soft contact lens wearers on a daily disposable wear basis.~   "
129152|NCT01365026|"~     The potential health gains from healthy lifestyles are very well-known, what is still not~     known is how to help people to adopt these lifestyles, by means of brief interventions~     feasible in routine general practice. This study was designed to explore the feasibility and~     efficacy of innovative implementation strategies for the promotion physical activity, diet~     and smoking abstinence in primary care. The investigators hypothesize that collegiate~     planning between practitioners, researchers and managers, with a socio-ecological~     perspective and taking into account the real context of collaborating centers, will~     guarantee the sustainability and effectiveness of these programs.~   "
129153|NCT01365013|"~     The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN~     Euskadi program for the primary prevention of type-II diabetes in high-risk population seen~     in primary care centers (Osakidetza-Basque Health Service) in which such intervention is~     implemented, compared to usual care control centers.~   "
129154|NCT01365000|"~     The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in~     Healthy Subjects.~   "
129155|NCT01364987|"~     This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in~     healthy volunteers.~   "
129156|NCT01364974|"~     The objective of this study is to explore safety and tolerability of multiple oral doses of~     ASP015K in healthy volunteers.~   "
129157|NCT01364961|"~     Although much effort has been done to lower LDL-cholesterol concentrations, there is still a~     substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for~     CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that~     elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite~     many initiatives, no new widely applicable intervention strategies with proven efficacy have~     been developed.~      Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower~     risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert~     a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has~     been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to~     elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in~     human intervention studies.~   "
129158|NCT01364948|"~     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits~     even more vulnerability to the environment due to poor self regulatory heat mechanisms,~     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight~     as water loss from their skin during the first week of life. Many strategies have been~     utilized by neonatologists to decrease this water loss. Oil application on the skin can act~     as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut~     oil, often used for traditional massage of babies by Indian communities, is culturally~     acceptable and Hence the investigators decided to undertake this study to objectively assess~     the reduction in water loss from skin after oil application~   "
129159|NCT01364935|"~     Comparative study to determine whether several fertility monitoring products - the~     DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are~     substantially equivalent in performance, and secondarily to determine the appropriateness of~     labeling information for the DuoFertility monitor.~   "
129160|NCT01364922|"~     The primary purpose of this study was to evaluate the analgesic effect and safety of~     hydrocodone/acetaminophen extended release compared to placebo.~   "
129161|NCT01364909|"~     This study will investigate whether early exercise in critically ill patients will decrease~     inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.~   "
129175|NCT01364727|"~     A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or~     thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for~     thymic cancers.~   "
129176|NCT01364714|"~     Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors~     report persevering limitation of physical capacity for years after discharge. Limited~     information is available about the underlying biomechanical properties responsible for this~     muscle function impairment.~   "
130526|NCT01346943|"~     The purpose of this study is to evaluate the safety of deploying and implanting the Altura~     Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in~     subjects who are candidates for open surgical aneurysm repair.~   "
129162|NCT01364896|"~     This is an observational cohort study with two time points (baseline and after at least 6~     months of treatment with a non-corticosteroid immunosuppressive agent for inflammatory bowel~     disease (IBD)). Approximately 40 participants, both male and female, 18 years of age and~     older will be recruited from the Pittsburgh IBD Cohort.~      Participants will have a histological diagnosis of IBD (Ulcerative Colitis (UC) or Crohn's~     Disease (CD)) and will be attending for colonoscopy prior to starting a non-corticosteroid~     immunosuppressive agent as part of standard medical care. Immediately following the~     colonoscopy, an anal exam will be performed for research purposes to include:~        1. Perianal inspection~        2. Anal canal HPV swab~        3. Anal cytology~        4. Digital anal examination~        5. High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria~          consistent with high-grade anal dysplasia~        6. For female participants a self- or clinician-taken vaginal swab for HPV typing.~      These procedures will be repeated at routine colonoscopy following at least 6 months but~     within 12 months of non-corticosteroid immunosuppressive treatment.~   "
129163|NCT01364883|"~     This is an open label phase I study, to assess the safety and immunogenicity of novel~     schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA~     ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved~     to be safe and capable of inducing protective cellular immune response following challenge~     with the parasite. All volunteers recruited will be healthy adults. They will be primed with~     AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP~     and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of~     the seven regimens. Secondary aims of this study will be to assess the immune responses~     generated by each of these regimes.~   "
129164|NCT01364870|"~     Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia.~     Minimizing the severe pain experienced during required activities in the immediate~     postoperative period will promote functional recovery and prevent the development of new~     chronic pain syndromes.~   "
129165|NCT01364857|"~     Port Wine Stain on a limb can be either isolated or associated with complications (venous or~     orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes~     (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).~      Little is known about epidemiology of port wine stains: their evolution during the growth of~     the child, the frequency of complications, genetic data, and prognostic factors.~      This prospective french national cohort will help for : description of the evolution of port~     wine stain and possible complications; prognostic factors for complications ; association~     with mutations of RASA1 gene; quality of life of these children. It will also help for~     global appreciation of the management of this disease in France.~   "
129166|NCT01364844|"~     This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability,~     identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your~     body does to process the drugs and how your body gets them out of your system.) and~     pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body)~     properties in subjects with advanced solid malignant tumors. This study will include 2~     parts: part 1-Dose Escalation and part 2-Dose Expansion.~      Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy~     properties in subjects with advanced solid malignant tumors for whom standard therapy has~     failed or for whom no standard therapy exists.~   "
129167|NCT01364831|"~     In the last few decades much knowledge has been accumulated on the connection between~     healthy, sufficient sleep and overall health, cognitive function, memory and job or school~     performance, motor vehicle accidents and work accidents. There has been growing awareness~     recently of the connection between physical activity and competitive sports performance, and~     the amount and quality of sleep. Despite the dearth of scientific studies, there is a~     constant effort to improve understanding in this field.~      An appropriate procedure designed to evaluate the influence of the quality and amount of~     sleep on ability and athletic performance must fulfill a number of basic requirements:~        1. Isolating the influence of components related to sleep homeostasis and factors relating~          to circadian rhythm.~        2. Neutralizing as much as possible the influence of motivation on the evaluation - one~          must presumably include a significant competitive event (it is not always possible to~          do a simple extrapolation between physiological measurements and competitive~          performance).~        3. Isolating and canceling as much as possible additional factors affecting performance,~          such as: home advantage, weather, injury and field conditions.~      Athletic activity includes not just competitions but also training towards competitions,~     since it is difficult to control for influences of competitions and other occasional events,~     in this study the investigators focus on evaluation of the connection between sleep and~     athletic performance in training.~      Towards the end of adolescence, youth are busy in multiple activities related to studies,~     social obligations and athletic activity. This is also the age they learn to drive. This is~     an age in which physiologically a person needs more sleep relative to at other ages (9.25~     hours of sleep a day), and paradoxically due to the multiple obligations the amount of sleep~     is lower than needed.~      Beyond the effect on mood, cognitive performance and memory, sleep deprivation causes~     far-reaching changes in multiple systems, such as:~      Cardiovascular System:~        -  Many studies show that shortened sleep duration constitutes an independent cause of~          increased cardiac events.~        -  Resting heart rate and maximum heart rate decrease after 30 hours of sleep deprivation.~      Respiratory System:~        -  Significant decline in respiratory function as measured by: FVC, Maximal voluntary~          ventilation, Maximal static inspiratory/expiratory pressures, Time to exhaustion with~          exercise, Peak O2 consumption, Peak CO2 production.~        -  Worsening of respiratory sleep disturbances.~      Digestive System:~      • Changes in food consumption accompanied by changes in body weight.~      Neurophysiological System~      • Disturbance of thermoregulation.~      Endocrine System:~        -  Hormonal changes associated with hypothalamic-hypophyseal axis~        -  Influence on secretion of Ghrelin and leptin~        -  Influence on secretion of growth hormone.~      In light of this, there is sound basis for the presumption that athletic performance is~     connected to these influences directly and indirectly.~      The purpose of this study is to evaluate the connection between sleep quality and duration~     and athletic performance among young athletes living and training at the Sport-Gifted Centre~     at the Wingate Institute.~   "
129168|NCT01364818|"~     The purpose of the proposed research is to study the potential changes in biomarkers of~     patients with neurodevelopmental disorders in response to treatment in clinical trials or in~     private psychiatry practice utilizing non-invasive psychophysiological measurements. The~     investigators plan to obtain psychophysical measurements throughout several periods of~     treatment.~   "
129169|NCT01364805|"~     In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each~     year and an almost equal number of deaths are related to this cancer. Different types of~     chemotherapeutic treatments are used that target different parts of the cancer cell with~     some success, but there is room for other treatment options.~      It is known that people with cancer are using high doses of intravenous vitamin C also known~     as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is~     given in this manner, it is not taken by mouth; instead, it enters your body through an IV~     (intravenous) site, or tube that is inserted through a needle into your vein. If you have a~     port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body~     through an IV site, it is known that it acts like a drug and not a vitamin. It produces a~     substance around the cancer cells called hydrogen peroxide. It has been seen in animal~     research studies that hydrogen peroxide kills the cancer cells while leaving the normal~     cells unharmed.~      Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer~     treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it~     is important to know that we do not expect the intravenous Vitamin C given in this study to~     be healing for the treatment of your cancer.~   "
129170|NCT01364792|"~     This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in~     24 clinical patients with Schizophrenia according to DSM IV, currently experiencing~     psychosis as is defined by the positive items of the Positive and Negative Syndrome Scale~     (PANNS) score, being five or higher on one item or four on two items of this scale. Each~     patient will be randomized to double blind treatment with either valaciclovir or placebo for~     one week.~      The main objective is to find a pre- and post-valaciclovir treatment difference in~     hippocampal inflammation, as measured with positron emission tomography. The secondary~     objective is to improve cognition by the supposed anti-inflammatory effect on the~     hippocampus of valaciclovir. This is measured by pre- and post-treatment performance on the~     PANSS, the attention and memory test.~      Both the treatment team and the patient will remain blinded during the course of the study.~     Following the active treatment phase, patients will receive treatment as clinically~     indicated.~   "
129171|NCT01364779|"~     The primary objective of the study is to determine the prevalence of aspirin resistance in~     chronic kidney disease patients. The secondary objectives are to determine possible risk~     factors contributing to aspirin resistance in this population.~   "
129172|NCT01364766|"~     The purpose of this study is to find the impact of continuous blood glucose sensors use in~     the classroom/school environment. We will be asking the subject,subject's parent and~     subject's teachers to complete a short survey/questionnaire. The survey will take~     approximately 10-15 minutes.~   "
129177|NCT01364701|"~     Clinical effectiveness is of the finest tools to evaluate treatment success and is combined~     of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the~     3 main PDE5i's differ in their molecular structure, therapeutic profile and~     pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower~     dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim~     of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose~     PDE5i's) versus single maximal dose PDE5i therapy.~   "
129178|NCT01364688|"~     Active vitamin D at therapeutic dose may prevent vascular calcification but in~     supraphysiologic dose may precipitate it.~   "
129179|NCT01364675|"~     The purpose of this study is to determine whether treating pre-diabetic & pre-hypertensive~     individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus~     anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower~     Cardiovascular Disease (CVD) events.~   "
129180|NCT01364662|"~     This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and~     safety study in children with impulsive aggression comorbid with~     Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and~     female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120~     subjects will be randomized across approximately 30 US centers to one of four treatment~     groups.~   "
129181|NCT01364649|"~     The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once~     daily (QD), compared with escitalopram on sexual functioning.~   "
129182|NCT01364545|"~     Parkinson's disease is a progressive condition that harms nerve cells of the brain~     (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep~     brain stimulation) improve certain symptoms but are not thought to improve the underlying~     neurodegenerative disease process (they are not a cure). The cause of Parkinson's disease~     is unknown. However, some evidence suggests that tiny structures in the investigators cells~     called mitochondria might be involved. Mitochondria are the powerhouses that produce fuel~     for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of~     certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a~     food called 'ketones' might be able to enhance the function of mitochondria and improve~     Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study,~     the investigators would like to investigate this possibility by giving patients with~     Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators~     will then assess if this improves symptoms of Parkinson's disease.~      The study design is a prospective, double blinded, randomised, controlled trial.~   "
129183|NCT01364532|"~     The transradial route is increasingly used as an access site in percutaneous coronary~     interventions, as it is considered equivalent to transfemoral approach in terms of efficacy~     but with a decreased vascular complication risk. Information concerning the efficacy and~     safety of transulnar approach is sparse. This is a prospective, randomized,~     investigator-initiated study to compare transradial versus transulnar approach as a default~     strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention~     (PCI). Consecutive eligible patients with an indication for coronary angiography, will be~     randomized after written informed consent in a 1:1 ratio to either transradial or transulnar~     access. Assessment of angiographic and procedural characteristics(including amount of~     contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular~     or other peri-procedural complications of the cases enrolled, will be performed. After~     hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound~     assessment of the forearm vessels and documentation of major adverse cardiovascular events~     (defined as death, myocardial infarction, target vessel revascularization and stroke.~     Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500~     or 5000 IU of unfractioned heparin.~   "
129184|NCT01364519|"~     Study to assess effect of Fluticasone Propionate on acute lung inflammation following~     inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers.~     Assessment of inflammation will be via sputum induction.~   "
129185|NCT01364506|"~     Objective: To assess the relationship between maternal cardiovascular capacity and aerobic~     water exercise during the gestational periods of hemodynamic overload. Study design:~     randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups:~     Control and Water exercise. Maternal cardiovascular capacity (maximum oxygen consumption,~     cardiac output, stroke volume, heart rate and mean arterial pressure), physical performance~     (relative HR, treadmill speed and self-perceived exertion) and neonatal outcome (gestational~     age, weight, Apgar index and length of infant's hospitalization) were assessed. Means were~     evaluated by dependent and independent t-tests, and proportions by the chi-square method~     (p<0.05). Results: The control variables showed that the groups were homogeneous. Water~     exercise was associated with maintenance of VO2max, increase in stroke volume and cardiac~     output, and better performance on stress tests in the third trimester of gestation. No~     significant difference in neonatal variables was observed. Conclusion: Water exercise~     maintained cardiovascular capacity and performance under submaximal stress, and did not~     affect hemodynamic adaptation to gestation or neonatal outcome.~   "
129186|NCT01364493|"~     Although the overall incidence of gastric cancer has steadily declined in many Western~     countries during the last few decades, it is still one of the most common tumors in China.~     It is now well recognised that combination chemotherapy regimens improve patient outcomes,~     but there is no accepted global standard regimen for advanced gastric cancer.~      The ToGA study was the first randomized, prospective, multicenter, phase III trial to show~     the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of~     death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference~     chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3~     months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced~     GC.~      Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable~     toxicity profile with a substantially lower rate of nephrotoxicity, ototoxicity, and~     myelosuppression.~      In the current study, the efficacy and safety of Trastuzumab in combination with~     Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2~     positive advanced or recurrent gastric cancer.~   "
129187|NCT01364480|"~     The purpose of this research study is to demonstrate the safety and efficacy of using two~     NeuroPort Arrays (electrodes) for long-term recording of brain activity.~   "
129188|NCT01364467|"~     This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of~     oral guaifenesin for the therapy of Chronic Rhinitis in 36 children between the ages of 7~     and 18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal~     symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal~     airway volume, and biophysical properties of nasal secretion. The investigators hypothesize~     that Guaifenesin use over a period of 14 days improves subjective nasal complaints in~     pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5~     survey compared to use of placebo. There will be an observed improvement in nasal volume and~     cross-sectional area following use of guaifenesin, and nasal secretions will have more~     favorable mucociliary and sneeze clearability compared to use of placebo.~   "
129189|NCT01364454|"~     Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence~     that it reduces mortality from CRC and that it's cost-effective. In France, there is a~     national CRC screening programme inviting people aged 50-74 years by mail to consult their~     General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every~     two years. Participation is a key factor for the screening programs success. High levels of~     screening uptake and the continued participation to regular screening must be achieved and~     maintained in the targeted population if the enormous potential of CRC screening is to be~     realised. Screening rates of various international programs vary widely (20-52%) and the~     participation is insufficient in the most settings. Therefore, a better understanding of~     facilitating and hindering factors of patient participation can guide interventions to~     improve CRC screening rates. They include patients and physicians' factors. One issue is~     about GPs practice. GP involvement has been shown to improve the participation in the CRC~     screening. This study aims to assess the effectiveness of an intervention targeting GPs to~     increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned~     to either the intervention group or to usual care (control group) and they will be followed~     one year. The intervention consists in providing every four months to the experimental group~     a list of their patients who are eligible but did not proceed yet to the screening. In both~     groups, patient participation in the screening will be measured at the end of the study.~   "
129190|NCT01364441|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952~     across ascending single doses in healthy adult male and female subjects. The secondary~     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary~     objective of this study is to preliminarily evaluate the effect of a meal upon the PK~     profile of ONO-2952.~   "
129191|NCT01364428|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in~     subjects with type 2 diabetes.~   "
129192|NCT01364415|"~     This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced~     Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics~     and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.~   "
129193|NCT01364402|"~     This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule~     for primary PCI or elective PCI will randomly allocated to receive either a single dose of~     EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.~      The investigators assume that the incidence rate of CIN will be significantly lower in the~     EPO group compared to placebo. In addition, EPO administration will result in a decrease of~     infarct size.~   "
129194|NCT01364389|"~     The study is a two-week, single-blinded, double-dummy, randomized, active-controlled,~     parallel group design, with a follow-up period up to a total study duration of 6-month,~     non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare.~     It is a multicentric, multinational study. The protocol will seek to enroll a total of 30~     patients, who will be randomized to the 3 arms at a ratio of 1:1:1.~      Patients will have a maximum screening period of 7 days with randomization at D1 for a~     dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days)~     after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in~     the case of a disease flare.~   "
129195|NCT01364376|"~     This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus~     5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative~     chemotherapy for advanced gastric cancer.~      Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric~     cancer.~   "
129196|NCT01364363|"~     The purpose of this study is to provide an opportunity for patients with malignancies or~     bone marrow failure states who lack a suitable sibling donor to undergo allogeneic~     hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord~     blood registries.~   "
129197|NCT01364350|"~     The purpose of this study is to continue to follow participants in the TODAY clinical trial~     as they transition to non-blinded, non-randomized standard diabetes care and management with~     monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are~     analyzed and findings interpreted to develop a long-term observational protocol (phase 2).~     Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.~   "
129198|NCT01364337|"~     Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given~     to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly~     prescribed with medications without comprehensive instructions on dietary therapy. DASH diet~     has been proven to be an effective dietary approach to reduce blood pressure for~     hypertension patients in US. However, dietary difference and patient profiles across~     countries are evident. In addition, hypertensive patients are often combined with~     hyperglycemia. Carbohydrate burden of DASH diet may be higher than most dietitians desire.~     Therefore, the investigators in tend to design a Taiwanese DASH diet and a lower~     carbohydrate DASH diet and test their efficacy on both blood pressure and fasting glucose~     lowering.~   "
129199|NCT01364324|"~     The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic~     profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).~   "
129237|NCT01363817|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either~     alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic~     leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from~     standard therapies~   "
129200|NCT01364311|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory~     response on the ocular surface. Common symptoms include ocular discomfort, visual impairment~     and instability of the tear film with potential damage to the ocular surface.~      In addition, an intact tear film is important to provide a smooth optical surface, to act as~     a barrier to pathogens, to nourish the epithelial cells of the ocular surface and to prevent~     exsiccation. Alterations in the tear film composition, which can have their origin in~     several conditions, lead to tear film hyperosmolarity or instability resulting in DES.~      Regardless of the cause of DES, chronic dryness of the ocular surface leads to an increased~     susceptibility to oxidative stress, which is triggered by reactive oxygen species (ROS).~     This results in cell damage and activation of the immune system, keeping up inflammatory~     processes . In order to prevent ROS damage, several micronutrients such as vitamin C, E, and~     certain carotenoids, omega-3 free fatty acids, flavonoids and minerals have been used~     because of their antioxidant capacities.~      Based on this knowledge the potential of these antioxidant dietary supplements has been~     discussed as a treatment option for DES. Preliminary data support the hypothesis that~     antioxidant supplementations, in particular, supplementation with omega 3 fatty acids may be~     beneficial for patients with DES.~      The purpose of the present study is to test the hypothesis that treatment with dietary~     supplements improves subjective and objective symptoms of DES.~   "
129201|NCT01364298|"~     This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare~     efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral~     neuropathy pain (DPNP) management.~   "
129202|NCT01364285|"~     The investigators know little about how patients feel following radiosurgery treatment of~     trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important~     outcome measures for an individual patient; however, this has not been adequately assessed~     or followed. Multiple questions remain unanswered, including whether there is a correlation~     between patient satisfaction, the level of their current pain score, and the presence and~     degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of~     this study is to gather this information from the patients who received radiosurgery for~     trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the~     degree of facial numbness, and current pain score. This data will help the investigators~     understand outcomes that are important for patient satisfaction following treatment of a~     chronic pain syndrome.~   "
129203|NCT01364272|"~     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that~     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery~     has been shown to provide pain relief in majority of patients treated. However, a common~     side effect of radiosurgery is facial numbness. To better understand how radiosurgery can~     bring about pain relief and facial numbness, we are conducting a study in which brain MRI~     scans will be done following stereotactic radiosurgery to learn if there are any changes in~     the MRI scans that correlate with symptoms.~   "
129204|NCT01364259|"~     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that~     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery~     has been shown to provide pain relief in majority of patients treated. However, a common~     side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while~     minimizing side effects. To this end, the purpose of this study is to evaluate whether~     adding a drug, amifostine, at the time of radiosurgery will protect patients from facial~     numbness.~   "
129205|NCT01364246|"~     Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune~     demyelinating disease of the central nervous system, along with a considerable pathological~     heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease,~     and its clinical characteristics include recurrent optic neuritis and longitudinally~     extensive transverse myelitis.~      Current therapies provide only modest control of progressive Multiple Sclerosis and~     Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an~     efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of~     Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients~     with progressive MS and NMO.~   "
129206|NCT01364233|"~     Surgically repair of large abdominal hernias requires prosthetic materials such as mesh-like~     products. A relatively new synthetic product cPTFE is designed as a cost effective~     alternative to reduce associated post surgical complications. The study will monitor~     patients over a one year period.~   "
129207|NCT01364220|"~     It is anticipated that 548 subjects will be recruited from approximately 27 centres in South~     Korea.~      This is an investigator-sponsored, double-blind, placebo-controlled, randomized,~     multi-centre study to assess the effects of rosuvastatin 20 mg compared to placebo in acute~     ischemic stroke patients, with the first dose within 18 hours after baseline MRI and~     continued treatment for 14 days.~      Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with~     baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3~     months.~      The objective would be to compare the recurrence rate of ischemic stroke by comparing the~     imaging parameters during 14 days of treatment and clinical improvement as defined by~     percent improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of~     treatment.~   "
129208|NCT01364207|"~     High intraocular pressure (IOP) is a known risk factor for developing primary open-angle~     glaucoma (POAG). There is controversy in the literature regarding the degree to which~     caffeine influences IOP, with some studies reporting minimal changes in IOP while others~     report up to 4 mmHg increases. To date there are no double-masked randomized controlled~     trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk~     for primary open-angle glaucoma. The investigators aim to better understand the relationship~     between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a~     double-masked, crossover randomized controlled clinical trial.~   "
129209|NCT01364194|"~     The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25%~     bupivacaine for controlling pain after total knee replacement to improve the quality of~     post-operative care.~   "
129238|NCT01363804|"~     This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK)~     profile of tivozanib.~   "
131417|NCT01335113|"~     The purpose of the investigators study is to determine the relationship between the length~     of the eye and the rate of change in eye length at each visit with progression of~     retinopathy of prematurity.~   "
129210|NCT01364181|"~     Pulmonary hypertension (PH) is a serious complication of COPD which is associated with~     shorter survival, more frequent exacerbation, and increased use of health resources. There~     is no effective pharmacological treatment for COPD-associated PH. Therefore, the~     investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5)~     inhibitor, on exercise capacity of severe COPD patients.~   "
129211|NCT01364168|"~     The primary aim of the study is to derive and validate risk scores for vascular endpoints~     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death~     following an incident stroke. For this purpose patients with an incident stroke will be~     followed for 36 months with additional assessments at 3, 12, 24 and 36 months.~   "
129212|NCT01364155|"~     Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral~     effects on weight in obese and diabetic rodent models. Results from a Phase 1b clinical~     study, conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be~     potential insulin sensitizers by OGTT.~   "
129213|NCT01364142|"~     One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji~     Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical~     practice. We will try to devise a blind method to locate the Uniblocker® without the aid of~     fiberoptic bronchoscopy.~   "
129214|NCT01364129|"~     This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect~     diabetic retinopathy when compared to traditional surveillance methods, 2) identify the~     health belief factors related to adherence with annual diabetic eye exams, and 3) determine~     the cost-effectiveness of the telemedicine system from the perspective of the community~     clinic, the third-party payer, and the individual patient.~   "
129215|NCT01364116|"~     Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion~     during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes~     noninvasive monitoring of venous hemoglobin level (SpHb).~      The objective of this study~        -  to compare the simultaneous level of tHb and SpHb during operation and after volume~          expansion in children~        -  to assess the accuracy of amount of acute change of SpHb on Masimo and tHb~   "
129216|NCT01364103|"~     The purpose of this study is to evaluate static and dynamic parameters, echocardiographic~     parameters, and pleth variability index for predicting fluid responsiveness in children.~     Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart~     rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta~     down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth~     variability index will be measure before and after volume expansion. Patients will be~     classified as responders to volume loading if stoke volume index increase by at least 15%.~   "
129217|NCT01364090|"~     This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and~     effective for patients who are current injection drug users or receiving opiate substitution~     therapy and who are responding well to treatment early on.~   "
129218|NCT01364077|"~     A significant association between resting heart rate (HR) and both all-cause mortality and~     cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both~     the general population and for patients with cardiovascular disease.~      Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent~     study reported that the 48-hr mean HR is an independent predictor of cardiovascular events~     in normotensive hemodialysis patients.~      Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial~     antianginal effects and mortality reduction linked to HR reduction in ischemic patients.~      Aim:~      To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with~     increased pre-dialysis HR (> 80 bpm)~   "
129219|NCT01364064|"~     This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive~     Temozolomide in Patients with Newly Diagnosed Glioblastoma.~   "
129220|NCT01364051|"~     This phase I trial studies the side effects and best dose of cediranib maleate and~     selumetinib in treating patients with solid malignancies. Cediranib maleate and selumetinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the~     tumor.~   "
129221|NCT01364025|"~     Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of~     hysterectomy?~      The answers to these questions will facilitate the treatment of many American women. With~     the results of this study, the investigators would anticipate a reduction in the number of~     surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was~     shown to be ineffective, it would not be used routinely in the setting of hysterectomy and~     women will be spared the additional procedure and possibility of side effects or~     complications.~      The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at~     the time of hysterectomy in women without symptomatic prolapse symptoms have never been~     studied prospectively.~   "
129222|NCT01364012|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of Avastin (bevacizumab) versus placebo in combination with carboplatin/paclitaxel in~     patients with advanced or recurrent non-squamous non-small cell lung cancer who have not~     received prior chemotherapy for advanced disease. Patients will be randomized to receive~     either Avastin 15 mg/kg intravenously or placebo on Day 1 of each 3-week cycle, plus up to 6~     cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs. After progression, patients in the Avastin-arm~     may continue to receive Avastin in combination with approved second- and third-line~     treatment at the discretion of the investigator, up to the third progression.~   "
129223|NCT01363999|"~     A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and~     atorvastatin from prototype fixed dose combination formulations in healthy volunteers.~     Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four~     treatment periods.~   "
129224|NCT01363986|"~     This single-arm, multicenter, open-label study will evaluate the efficacy and safety of~     Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in~     patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg~     (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time~     on study treatment is 18 weeks.~   "
129225|NCT01363973|"~     Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke.~     Despite its enormous impact on functional capacity, quality of life, and survival, OD is~     both underestimated and underdiagnosed as a cause of major nutritional and respiratory~     complications in stroke patients. A recent systematic review on the effects of~     rehabilitation therapy on OD concluded that although some positive effects were found, the~     number of studies was small, many of them had methodological problems and there was a need~     for further research using randomized controlled trials. Transcutaneous electrical~     stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is~     traditionally used to activate pharyngeal muscles through stimulation of peripheral motor~     nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and~     safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007,~     Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On~     the other hand, in recent years, transcutaneous electrical stimulation is beginning to use~     as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our~     research strategy includes the assessment of the therapeutic effect of these two main~     strategies using transcutaneous electrical stimulation on swallow physiology and clinical~     outcomes of post-stroke dysphagic patients.~   "
129226|NCT01363960|"~     The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity~     screening.~   "
129227|NCT01363947|"~     Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A~     administered as a single agent by intravenous (IV) infusion to patients with non-squamous~     NSCLC or non-mucinous, platinum resistant ovarian cancer.~   "
129228|NCT01363934|"~     This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active~     controlled, Dose-escalation Study to investigate the safety, tolerability, and~     Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous~     Administration in Healthy Male Subjects.~   "
129229|NCT01363921|"~     The purpose of this study is to determine whether high porous membranes are effective in the~     treatment of cardiovascular events in chronic dialysis patients.~   "
129230|NCT01363908|"~     This is an open-label study to assess the pharmacokinetics, safety, efficacy and~     tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase,~     using a single 16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which~     patients will receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be~     studied: 6-<12, and 12-<18 years old. The study is designed to initially assess the~     pharmacokinetics and safety of SSP-004184AQ in older children (adolescents, 12-<18 years~     old) and then if deemed safe, in younger children (6-<12 years old).~   "
129231|NCT01363895|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, associated with an~     increased risk of morbidity and mortality1. The management of AF patients is aimed at~     reducing symptoms and at preventing severe complications associated with AF. In the last~     years, two new strategies have emerged with different objectives. In the PROTECT AF study2,~     percutaneous closure of the Left Atrial Appendage (LAA) with a closure device provided an~     alternative strategy to oral anticoagulation for stroke prophylaxis. The AFFIRM trial3 has~     shown that drug-based management of AF with a rhythm-control strategy conferred no advantage~     over a rate-control strategy in cardiovascular mortality and might be associated with an~     increased noncardiovascular death rate4. Catheter ablation has gained a greater place in the~     rhythm control strategy, showing superiority in maintaining sinus rhythm in comparison with~     AAD5. However, in persistent AF, repeat ablation procedures are necessary in up to 70% of~     patients to achieve sinus rhythm at a long-term follow-up6-7.~      This prospective, randomized trial will compare the percutaneous closure of the LAA combined~     with a rate-control strategy to catheter ablation in the management of patients with~     persistent AF. Patients who are eligible for catheter ablation as well as LAA closure device~     implantation and are willing to participate in the study will be randomly assigned to~     catheter ablation or percutaneous closure of the LAA by a closure device implantation in the~     relation 1:1. The primary endpoint of the study is a composite endpoint at 12 months of all~     cause death, thrombo-embolic events, major bleeding (BARC type 3), re-hospitalisation and~     severe symptoms due to arrhythmias. Secondary endpoints include a composite endpoint of~     bleeding, a composite endpoint of thrombo-embolic events, cardio-vascular mortality, total~     duration of hospitalisation, sustained discontinued anticoagulation, quality of life~     improvement, use of Antiarrhythmic Drugs (AAD), total costs, freedom from arrhythmia and~     average ventricular frequency in 7-day holter ECG at 12 months.~      The objective of the study is to assess the superiority of percutaneous closure of the LAA~     combined with rate-control to catheter ablation in patients with oligosymptomatic AF.~   "
129232|NCT01363882|"~     Use of noninvasive ventilation (NIV, also known colloquially as Bipap) has been associated~     in some studies with improvement in pulmonary function, quality of life and survival. NIV is~     typically applied during sleep, and without the benefit of sleep study to determine the~     optimal settings. The investigators have shown that when NIV is used in this fashion,~     failure of nocturnal oxygenation and ventilation is prominent. This study is randomizing~     patients to standard application of NIV vs application guided by use of sleep study data to~     determine the effect of titrated therapy on pulmonary function, quality of life and~     survival.~   "
129233|NCT01363869|"~     Green tea has been extensively investigated for several potential health benefits. Previous~     studies have suggested that green tea may lower serum uric acid level in human. The purpose~     of this study is to investigate uric-lowering properties of green tea in healthy~     individuals.~   "
129234|NCT01363856|"~     The primary aim of the study is to derive and validate risk scores for vascular endpoints~     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death~     following an incident stroke. For this purpose patients with an incident stroke will be~     followed for 36 months with additional assessments at 12, 24 and 36 months.~   "
129235|NCT01363843|"~     The purpose of this study is to find out how well patients with cancer of the rectum do if~     they get all of their other treatment - chemotherapy by itself followed by chemotherapy and~     radiation together - before surgery. Patients have recently been diagnosed with rectal~     cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the~     cancer before removing it.~   "
129236|NCT01363830|"~     Post-operative restrictions following lumbar discectomy is a controversial topic. While the~     most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks~     following discectomy, a number of studies support an early return to full activity without~     restriction. Since the goal of discectomy is to promptly provide pain relief and a return to~     a fully active lifestyle, perhaps post-operative restrictions are more hindering than~     beneficial.~      Hypothesis: Post-operative restrictions following lumbar discectomy do not influence~     reherniation rate.~      Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the~     2-weeks of restriction groups.~      Specific Aim 2: To determine the return to full activity and return to work dates of both~     the 6-weeks of restriction and 2-weeks of restriction groups.~      Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks~     of restriction groups.~   "
131483|NCT01334242|"~     The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to~     meals in healthy subjects.~   "
129239|NCT01363791|"~     Diabetes and heart associations continue to discourage high intakes of dietary fructose, a~     constituent part of the sucrose molecule that is found in fruits and vegetables as a natural~     sugar and in some processed foods and beverages as an added sweetener. The concern relates~     to its ability to increase certain blood fats and cholesterol, which increase the risk of~     cardiovascular disease. The evidence for an adverse effect of fructose on these risk~     factors, however, is inconclusive. To improve the evidence on which nutrition~     recommendations for fructose are based, the investigators therefore propose to study the~     effect of fructose on blood fats, cholesterol, sugars, blood pressure, and body weight, by~     undertaking a systematic synthesis of the data taken from all available clinical studies in~     humans. This technique has the strength of allowing all of the available data to be pooled~     together and differences to be explored in groups of different study participants (healthy~     humans of different sex, weight, and age and in those with diseases which predispose to~     disturbances in metabolism, such as diabetes) with dietary fructose in different forms,~     doses, and with differing durations of exposure. The findings generated by this proposed~     knowledge synthesis will help improve the health of consumers through informing~     recommendations for the general public, as well as those at risk of diabetes and~     cardiovascular disease.~   "
129240|NCT01363778|"~     This study is designed to evaluate the effect ketoconazole on the Pharmacokinetic profile of~     tivozanib.~   "
129241|NCT01363765|"~     Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and~     inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture~     of sputum yields a correct diagnosis in up to 90% of cases, but results are only available~     in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid~     technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95%~     of cases, in addition to identification of cases resistant to certain drugs used to treat~     TB. The test is expensive, but several studies have demonstrated its accuracy, and since~     most steps are automatized, savings can be expected from human resources work. The aims of~     our study are (1) to evaluate this tool as a substitute test for sputum smears in routine~     conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may~     outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and~     health care workers.~   "
129242|NCT01363752|"~     The purpose of this study is to compare the effect of two anti-rejection therapy regimens on~     kidney function in kidney transplant recipients.~   "
129243|NCT01363739|"~     -1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a~     role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of~     metastatic colorectal cancer patients. The present study aims to prospectively evaluate the~     predictive role of this polymorphism in metastatic colorectal patients receiving the same~     treatment.~   "
129244|NCT01363726|"~     The purpose of this study is to monitor diarrheal disease and observe changes after the~     introduction of the rota vaccine.~   "
129245|NCT01363713|"~     Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with~     allergic conjunctivitis, in an open-label, multicenter study.~   "
129246|NCT01363700|"~     The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution~     compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients~     with allergic conjunctivitis.~   "
129247|NCT01363687|"~     The purpose of this study is to investigate whether upper limb ischemic postconditioning can~     improve renal function and decrease ischemic-reperfusion injury in patients undergoing~     living donor kidney transplantation.~   "
129248|NCT01363674|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment from hospitals in Greece and to assess the level of adherence of~     subjects receiving SAIZEN® via Easypod™.~   "
129249|NCT01363661|"~     Molsidomine used as an add-on treatment on standard care therapy should be superior to~     placebo used also as an add-on treatment on standard care therapy on improving the~     endothelial function (endothelium score measured by reactive hyperemia - peripheral arterial~     tonometry [RH-PAT]) after 12 months of treatment in patients with stable angina patients and~     undergoing elective percutaneous coronary intervention.~      The study will be double-blind, parallel-group, randomised, multicentre, sequential,~     placebo-controlled study.~      The device used to determine RH-PAT will be EndoPAT. Duration of the treatment = one year.~   "
129250|NCT01363648|"~     To date, there are no approved treatments for vascular cognitive impairment (VCI) and the~     main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI~     development or progression. Several studies have reported cholinergic deficits in brain and~     cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical~     studies of Alzheimer's disease and VCI improved memory and attention impairments. The~     purpose of our study is to determine effectiveness of choline alphoscerate vs placebo in~     improving cognition in post-stroke patients with VCI-non dementia (VCI-ND).~   "
129251|NCT01363635|"~     Severe sepsis/septic shock are serious complications of infection with high morbidity and~     mortality. Recent information showed that early and aggressive resuscitation with goal~     directed therapy help improving survival and outcome especially the resuscitation within the~     first 6 hours. In surgical patients, either severe sepsis/septic shock bought them to the~     operating room or this sepsis might be found after surgery resulting in higher morbidity and~     mortality. Not only knowledge management, others possible risk factors should also be~     identified and corrected for outcome improving. This prospective observational study will be~     done in 800 adult surgical patients admitting to the general surgical intensive care unit.~     Incidence of severe sepsis/septic shock on admission along with risk factors associated with~     poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length~     of, stay, ICU death] will be recorded especially effect of amount and type of fluid~     replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Knowledge about~     severe sepsis/septic shock was implemented among the associated personal, outcome as major~     organ failure, ICU length of stay, ICU death will also be compare between this prospective~     study and historical controlled.~   "
130886|NCT01342224|"~     This study will add an immunotherapy component to chemotherapy and radiation treatment in~     patients who have pancreatic cancer. The objective of this study is to see if the combined~     treatment is safe and feasible, and if a larger study is warranted.~   "
129252|NCT01363622|"~     The aim of this study was to investigate circulating concentrations of vaspin in fetal and~     neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum~     vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA~     singleton full-term fetuses and neonates on cord blood and postnatal day 5.~   "
129253|NCT01363609|"~     The aim of this study is to investigate if endogenous Glucagon Like Peptide -1 (GLP-1) has~     an effect on brain satiety and reward systems and if there are alterations in obese patients~     with type 2 diabetes (T2DM). Secondly, the aim is to investigate whether treatment with a~     GLP-1 analog, liraglutide, restores these signals in obese patients with type 2 diabetes.~     Finally, also the endogenous GLP-1 effects will be investigated in obese individuals before~     and after gastric bypass surgery on brain satiety and reward systems.~   "
129254|NCT01363596|"~     NaProTechnology (NPT) is a treatment option for infertility or miscarriage that identifies~     issues in a couple's fertility and fixes them to the extent possible by medical~     intervention. An important part of NPT is teaching couples to monitor the signs and symptoms~     of the woman's fertility cycle (menstrual cycle) with the Creighton Model FertilityCare~     System (CrMS).~      The purpose of the study is to look at outcomes among couples who consider or get NPT~     treatment to help them have a live birth. Results from the study will be used to answer~     questions such as:~      How many couples who use NPT get pregnant and have a baby? How can NPT treatment be~     improved? Does NPT treatment have fewer long-term health risks for the resulting children~     than other fertility treatments? What types of characteristics or environmental exposures~     influence whether NPT will be successful for a specific couple?~      To be eligible for the iNEST study, a couple must have a consultation with a NPT-trained~     clinician who is participating in iNEST.~   "
129255|NCT01363583|"~     This study is a prospective consecutive double-blinded randomized study on the effect of~     PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe~     traumatic brain injury. All patients with severe traumatic brain injury were eligible for~     inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at~     intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion~     pressure (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.~      Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a~     lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.~      A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers,~     measured by different cytokines.~   "
129256|NCT01363570|"~     Age Related Macular Degeneration (AMD) is the leading cause of blindness in North America.~     This condition causes a progressive loss of central vision, the part of your vision that~     allows you to read, drive and see images in sharp detail directly in front of you. The wet~     form of AMD is characterized by the growth and leakage of small blood vessels into the~     choroid layer of the eye, or the back of the eye. These leaking blood vessels disrupt the~     structure and function of the eye, causing loss of vision, particularly the sharp vision~     created by the macula area of the eye.~      Currently, the best treatment for wet AMD is a series of injections of an anti-vascular~     endothelial growth factor (anti-VEGF) drug, ranibizumab (Lucentis). The clinical response to~     treatment is varied. Approximately 70% of patients see a moderate vision gain (3-line gain~     on a visual acuity chart), but there are 30% who do not see a similar improvement in vision.~     There is no way to identify those patients who will respond with significant vision gain~     versus those who will not experience moderate vision gain. Recent research into AMD has~     demonstrated that genetic mutations are proving to be key risk factors for patients~     developing wet AMD, with up to 80% of wet AMD cases explained by inherited genetic~     variations. Scientists have theorized that there may be a genetic difference between those~     patients who see significant responses to treatment and those who do not. The investigators~     will be testing participant's genetic profile using the Macula Risk test and following their~     progress through the standard treatment for wet AMD over the course of this study. This~     study aims to demonstrate the association between known genetic variations and patient~     responses to treatment.~   "
129257|NCT01363557|"~     Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in~     addition to Gefitinib for the management of brain metastasis in lung cancer patients with a~     mutated EGFR.~   "
129258|NCT01363544|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a~     severe impact on a child's life and society. The core symptoms are attention problems,~     hyperactivity and impulsivity. These symptoms are related to disruptions in neurocognitive~     functions (such as inhibition: the ability to stop behavior) and disruptions in cortical~     regulation (such as 'cortical underarousal' as measured with the electroencephalogram). To~     date, the only evidence-based treatment is pharmacological. Medication is not effective in~     20-30% of the children with ADHD and it can have side effects. The lack of alternatives for~     medication is a severe problem for these children and society.~      Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a~     training in which a person learns to alter its cortical regulation. Neurofeedback has been~     classified as 'probably effective' but its treatment effects need further empirical~     evidence. Non specific training effects, such as individual attention, may also contribute~     to treatment success. In this research project the investigators compare the efficacy of~     neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable~     with neurofeedback in terms of non-specific effects. Exercise is also a promising treatment~     because of its positive effects on behavior, neurocognition in several patient groups. For~     these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators~     compare the efficacy of these two treatments with an optimal pharmacological treatment with~     methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in~     efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of~     ADHD). Secondary outcome measures include neurocognition and cortical regulation. This~     research project will give answer to the question if neurofeedback and exercise are as~     effective as MPH. Furthermore, it will give insight in how these interventions will give~     rise to improvements in behavior.~   "
129259|NCT01363531|"~     The general hypothesis is that delayed antibiotic treatment strategies present similar~     effectiveness, when compared with non-prescription of antibiotics or the prescription of~     antibiotics, in the non-complicated acute respiratory tract infections.~   "
129284|NCT01363193|"~     Standard weight-based IV heparin for normal weight patients is based on actual body weight~     (ABW). However, no well-defined guidelines have been established for patients considered to~     be obese or morbidly obese. In current practice, the calculated ABW based heparin initial~     bolus dose and infusion rates are quite high, and therefore often not used for~     obese/morbidly obese patients for fear of bleeding.~      Heparin is distributed in the body approximately the same as blood and does not get~     distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW)~     might be a better basis for dosing heparin. LBW is a calculated weight that excludes the~     weight of fat.~      The investigators hypothesize that intravenous heparin dosing based on the Lean body weight~     of obese/morbidly obese patients would be safe and effective in achieving a therapeutic~     level of heparin in 24 hours compared to the usual practice in this patient population.~   "
129260|NCT01363518|"~     The subject's broken humerus (arm) is suitable for treatment with a fracture brace or~     operative fixation with plate and screws. Both of these types of treatments are often used~     by doctors to fix broken bones. If the subject agrees to participate in this study, the~     subject will be assigned by the treating surgeon to one of the following groups:~      Group B: Non-operative treatment with a fracture brace Group P: a plate & screws - a metal~     device placed on top of the bone.~      The investigators will collect information about the subject's arm fracture as it is treated~     with examinations and X-rays. X-rays will be obtained often in the first several months,~     depending on how the fracture is healing. This is determined by the doctor and will not be~     determined by the subject's participation in this research study.~      Both treatments are routinely used and this study hopes to provide information regarding~     each type of treatment on the subject's functional outcome. A subject's treatment will not~     be affected whether they choose to participate in this research study or not.~      The treatment of these subjects is no different because of this study. The treating surgeon~     will discuss with the patient their preferred treatment for the isolated humeral shaft~     fracture. If they meet the inclusion/exclusion criteria, they will be approached for~     participation in one of two treatment groups depending on a previous decision by the patient~     and the treating surgeon.~      Hypotheses:~        1. Patients with an isolated humeral shaft fracture that are plated will have a more rapid~          return to ADL's, work and full functional capacity than patients treated~          conservatively.~        2. Patients treated with plate technique will have a more rapid improvement in functional~          outcome scores, decreased pain scores and patient satisfaction than those managed~          conservatively.~        3. Complication rates of infection and iatrogenic neurologic injury will be higher in~          patients treated operatively.~        4. Nonunion and malunion will be higher in patients managed conservatively.~   "
129261|NCT01363505|"~     Studies have shown that more than 30% of the overall acute decompensated heart failure~     (ADHF) patients develop renal dysfunction.~      Several studies have tried to find a correlation between hemodynamic Parameters (blood~     pressure , heart rate, central venous pressure CVP) and worsening of renal function in acute~     decompensated heart failure patients.~      Results showed that there were no correlation between baseline hemodynamics or change in~     hemodynamics and worsening of renal function.~      Another study showed that intra-abdominal pressure (IAP) measuring was a better corollary to~     renal failure status then measuring cardiovascular hemodynamics using pulmonary artery~     catheterization in ADHF patients.. An increased IAP was associated with worse renal function~     and that level of IAP far below abdominal compartment syndrome may adversely affect renal~     function in patients with ADHF.~   "
129262|NCT01363492|"~     The purpose of this study is to assess the safety of Replagal in children with Fabry disease~     who who have not previously been treated with enzyme replacement therapy (ERT).~   "
129263|NCT01363479|"~     PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of~     palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic~     drug), both given with oral dexamethasone. The objective of the study is to demonstrate that~     oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to~     prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24~     hours after administration of a single cycle of highly emetogenic chemotherapy.~   "
129264|NCT01363466|"~     GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional~     relapse, especially in patient with a reduced metastatic risk and who received a local~     chemoradiation therapy with an increase of radiotherapy doses (45 grays).~   "
129265|NCT01363453|"~     The aim of the non-interventional study is to document the daily doses in acute and~     remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage~     forms are added and, when and how long steroids are given.~   "
129266|NCT01363440|"~     The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection~     (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early~     treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema~     (DME) with central involvement.~   "
129267|NCT01363427|"~     The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine~     in recently diagnosed patients with Morbus Crohn by retrospective data collection.~   "
129268|NCT01363414|"~     Eyes with abnormal tear film function have been found to show larger optical aberrations~     than normal eyes which may be attributed to the unstable and irregular tear film, uneven~     ocular surface, and increased scatter due to the exposure of the rough surface of corneal~     epithelium after tear break-up.~      These hypotheses have been supported by the findings that instillation of artificial tears~     (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular~     aberrations, improving the optical quality of the retinal image.~      However, the previous studies only evaluated the short-term effects of a single~     administration of an artificial tear but did not determine the duration of action or~     inflection point at which the ocular aberrations increase back to baseline. Also, there has~     clearly been no such clinical trial that has been a well randomized controlled study to~     date.~      This report is the first randomized controlled trial that investigated the long-term effects~     of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in~     patients with dry eye.~   "
129269|NCT01363401|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone~     marrow-derived stem cells(HYNR-CS inj), through intrathecal delivery for the treatment in~     patients with ALS.~      This study consists of 2 steps. First step is a safety study of the intrathecal(IT)~     injection of HYNR-CS inj in 8 patients with ALS. In this phase 1 study, AE, laboratory~     test, physical examination, vital signs, Electrocardiogram, and Chest X-Ray examination were~     evaluated in terms of safety.~      Second step is to compare the efficacy and safety between test group and control group of~     total 64 patients with ALS.~   "
129270|NCT01363388|"~     The aim of this trial is to optimize the treatment to induce remission for patients with~     non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to~     reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating~     entirely the use of systemic corticosteroids during the induction period with an inhibitor~     of the complement C5a receptor plus cyclophosphamide or rituximab.~   "
129282|NCT01363232|"~     This is an open label, dose finding, phase Ib clinical trial to determine the maximum~     tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered~     phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2~     inhibitor MEK162. This combination will be explored in patients with epidermal growth factor~     receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR~     inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal~     cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or~     BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with~     overdose control. At MTD or RP2D, two expansion arms will be opened in order to further~     assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.~      Study drugs will be administered once daily orally on a continuous schedule. A treatment~     cycle is defined as 28 days.~   "
129271|NCT01363375|"~     Excessive repetitive loading concentrating upon plantar fascia is considered as the most~     influential factor in plantar fasciitis development. Abnormal foot structure may lead to~     high risk of plantar fasciitis. However, the biomechanical factor that may cause plantar~     fasciitis has not been thoroughly investigated. Orthotic device is a common treatment used~     for plantar fasciitis. However, there is no direct and quantitative data, such as stress and~     strain distribution of plantar fascia for patient with foot orthosis during gait. Therefore,~     the aim of this three-year project study is to investigate the biomechanical mechanism of~     different foot structures and to understand the biomechanical response of plantar fascia~     during stance phase of gait cycle by dynamic finite element analysis, gait analysis as well~     as plantar pressure measurement. In addition, the efficacy of foot orthoses will be~     evaluated by the same research process. The hypotheses are that flat foot and high arch foot~     may result in higher stress and strain upon plantar fascia during gait; the foot orthosis,~     such as total contact insole, carbon fiber plate and rocker bottom sole, would reduce stress~     and strain distribution around the calcaneal medial tuberosity; rigid and curved geometric~     bottom will be able to relief plantar fascia stretching during push-off phase.~   "
129272|NCT01363362|"~     Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma~     patients. This study investigates, if there are changes in different ocular hemodynamic~     parameters prior and after SLT.~   "
129273|NCT01363349|"~     This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate~     the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary~     efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy~     endpoints will occur after 12 and 24 weeks of treatment.~      Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study~     will utilize a flexible dose escalation scheme designed to allow patients to titrate to~     their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a~     maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID~     (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will~     be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy~     design).~   "
129274|NCT01363336|"~     This study is a post-marketing surveillance in Japan, and it is a local prospective, company~     sponsored and observational study of patient who have been treated by Adalat CR for~     hypertension with diabetes and/or chronic kidney disease. The objective of this study is to~     assess safety and efficacy profile of using Adalat CR in real clinical practice. A total~     2,000 patients will be recruited and be observed for 6 months. Then, patient of whom~     microalbumin urea and serum creatinine are continuously monitored are additionally followed~     for 6 months.~   "
129275|NCT01363323|"~     This study will employ a single-center, randomized, double-blind parallel-group design for~     MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm~     methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained~     after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to~     placebo.~   "
129276|NCT01363310|"~     Most individuals with major depressive disorder manifest clinically significant agitation.~     Concurrent agitation in a depressed individual is associated with an intensification of mood~     symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and~     increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in~     the depressed patient often invites the need for augmentation strategies (e.g. atypical~     antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover,~     individuals with major depressive disorder often report worsening of symptom severity,~     irritability, hostility, dysphoria, and significant subjective distress (This response~     pattern is similar to individuals with bipolar disorder).~      Results from large research studies provide evidence indicating that quetiapine is capable~     of offering clinically significant multidimensional symptom relief in bipolar depression.~     Moreover, results from several trials in major depressive disorder and generalized anxiety~     disorder have established the efficacy of quetiapine therapy for unipolar depression and~     anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically~     for the treatment of agitated depression.~      In this study, it is hypothesized that persons with major depressive disorder and prominent~     agitation (i.e. agitated depression) will exhibit a more favourable response and~     tolerability profile to quetiapine XR when compared to escitalopram.~   "
129277|NCT01363297|"~     The Phase 1 portion of this study will assess the safety, tolerability and efficacy at~     increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or~     refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2~     dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of~     inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in~     second or later salvage status.~   "
129278|NCT01363284|"~     The purpose of this study is to identify, prior to prescribing, which neuropathic pain~     patients will benefit from duloxetine more specific the investigators aims are to:~        -  Verify whether presence of chronic pain alters the pain modulation mechanisms, such as~          DNIC (diffuse noxious inhibitory control) and TS (temporal summation).~        -  Investigate whether anti-neuropathic medications such as duloxetine indeed change the~          pain modulation profile, and whether this profile change is associated with a reduction~          of clinical pain.~   "
129279|NCT01363271|"~     This is a retrospective, observational, non-interventional drug study using de-identified~     data from two administrative claims datasets. The study design and analysis will reflect the~     perspective of the commercially insured. The objectives of this study are twofold:~        1. To compare the rates of re-hospitalization among patients treated with either linezolid~          orally or IV, or vancomycin IV for complicated skin and skin structure infections~          (cSSSI) or pneumonia hospitalization.~        2. To compare the total direct medical costs of patients treated with linezolid orally or~          IV, or vancomycin IV for cSSSI or pneumonia hospitalization.~   "
129280|NCT01363258|"~     The main purpose of this study is to test a method of providing mouth care to persons with~     dementia who live in nursing homes. The method of providing mouth care is designed to reduce~     fear in persons with dementia, so that these persons do not resist mouth care.~   "
129281|NCT01363245|"~     The investigators plan to compare the effectiveness and cost effectiveness of an inpatient~     smoking cessation intervention for all smokers hospitalized at two urban public hospitals.~   "
129285|NCT01363180|"~     This project is the first to use a clinical laboratory method in emerging adults to test the~     hypothesis that a trauma history with or without concommitant posttraumatic stress disorder~     (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The~     study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on~     these outcomes. It will also examine the relationship between stress reactivity and~     subsequent stress-induced drinking in these samples. The goal of this program is to better~     understand the relationship between stress and factors related to the development and~     maintenance of alcohol problems in early adults, so that ultimately, better treatments may~     be developed that reduce the incidence and severity of alcohol related problems.~   "
129286|NCT01363167|"~     This study is to determine the amount of vitamin D required for a very low birth weight~     infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.~   "
129287|NCT01363154|"~     The purpose of this clinical trial is to examine the effect of non-invasive cortical~     activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two~     Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has~     indicated that such evoked activity (i.e. by specific music) can result in significant~     reductions, or even complete termination of epileptiform activity and/or seizures across a~     broad range of individuals with epilepsy. A hypothesis is generated that specific music~     activation would beneficially effect photoparoxysmal based epileptiform abnormalities.~   "
129288|NCT01363141|"~     The investigators have previously demonstrated that Advanced Glycation End products (AGEs)~     are associated with several chronic diseases in humans and that blood AGE levels can be~     significantly reduced by simply changing the way food is cooked.~      This is an interventional-randomized study in which we are trying to determine whether a~     diet low in AGE followed for 1 year can effectively reduce circulating AGE levels as well as~     markers of the metabolic syndrome in a group of patients with these abnormal markers.~   "
129289|NCT01363128|"~     The goal of this clinical research study is to learn if ofatumumab combined with standard~     chemotherapy can help to control ALL. The safety of these drug combinations will also be~     studied.~   "
129290|NCT01363115|"~     The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D)~     supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese~     adults.~   "
129291|NCT01363102|"~     The investigators hypothesize that by applying a validated algorithm to accomplish early~     mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a~     higher level of mobility which translates to shorter ICU length of stay and improved~     functional status at discharge. Additionally, the investigators hypothesize that genetic~     polymorphisms related to muscle strength and sleep will also explain some variance in these~     outcome variables.~   "
129292|NCT01363089|"~     This was an open label, two way crossover study in healthy male subjects. Two treatments~     were administered to each subject, one treatment per study period, in a randomized manner.~     Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning~     of Day 2 of each period and there was a washout period of at least 2 days between~     treatments. A post study medical examination was performed prior to discharge in Period 2.~      The objective of this study was to assess the effects of a single dose of intranasal~     oxymetazoline hydrochloride on the pharmacokinetics of intranasal ketorolac in healthy male~     subjects.~   "
129293|NCT01363076|"~     This was an open-label PK study in pediatric subjects who had undergone general surgery.~     Each subject's study participation consisted of a screening visit, a single-dose treatment~     with intranasal ketorolac (IN) tromethamine, and a follow-up visit.~      Following surgery, subjects received IN ketorolac 15 mg (weight < 50 kg) or 30 mg (weight >~     or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the~     subjects had access to an opioid analgesic administered by patient-controlled analgesia~     (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points~     following the dose of ketorolac.~   "
129294|NCT01363063|"~     This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each~     subject participated in only one part of the study. In Part A subjects received one dose of~     15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril~     and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the~     other nostril, in a randomized manner. In Part B subjects were randomized to receive a~     single intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride~     into one nostril and either placebo or a single intranasal dose of 15 mg ketorolac~     tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During~     the study, subjects remained resident from the morning of Day 1 until the afternoon of Day~     1, when a post-study medical was performed prior to discharge.~      The objective of this study was to compare the tolerability of formulations of ketorolac~     tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A~     and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy~     volunteers.~   "
129295|NCT01363050|"~     This was a phase 1, open label, multiple dose study in healthy male and female volunteers.~     Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for~     three days (seven doses in total). Doses were administered every eight hours.~      The objective of this study in healthy volunteers was to determine the safety, tolerability,~     and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.~   "
129296|NCT01363037|"~     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine~     and maraviroc vaginal ring and determine whether it is safe when used continuously for 28~     days by healthy women in the United States.~   "
129297|NCT01363024|"~     This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability~     and Pharmacokinetics of MGFR1877S.~   "
129298|NCT01363011|"~     This study is to characterize the effect of cobicistat-based regimens on parameters of renal~     function in participants with HIV infection and who have mild to moderate renal impairment,~     and to assess the safety and tolerability of the regimens in order to generate appropriate~     dosing recommendations.~   "
129317|NCT01362764|"~     The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is~     absorbed in the body, distributed within the body, and how it is removed from the body) of~     the solution formulation to the tablet formulation; therefore the lowest dose available in~     the tablet formulation (250 mg) was selected.~   "
129299|NCT01362998|"~     For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot~     epidural preservative free morphine with a continuous epidural fentanyl infusion. The~     investigators will be comparing the patient's pain level and satisfaction with the two~     techniques, as well as the side effects that the patients experience, such as itching,~     nausea, back pain and respiratory depression.~   "
129300|NCT01362985|"~     Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the~     European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of~     plerixafor will be collected for data entered over a 5 year time span (i.e., data entered~     into the registry between the date of European Union (EU) marketing authorization [31 July~     2009] and 31 July 2014).~      The EBMT is a non-profit, scientific society representing more than 600 transplant centers~     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation~     or cellular therapy, which includes registering all the activity relating to stem cell~     transplants. Data are entered, managed, and maintained in a central database with internet~     access; each EBMT center is represented in this database.~      The collection by the EBMT registry of reasons for the off-label transplant use of~     plerixafor shall provide information of a substantial number of patients who are~     representative of the patient population receiving plerixafor off-label.~   "
129301|NCT01362972|"~     In the European Union (EU), plerixafor is indicated in combination with granulocyte colony~     stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells (HSCs) to~     the peripheral blood (PB) for collection and subsequent autologous transplantation in~     patients with lymphoma and multiple myeloma (MM) whose cells mobilise poorly.~      This is a clinical outcome analysis of a prospectively defined cohort of patients with data~     reported retrospectively to the European Group for Blood and Marrow Transplantation (EBMT)~     who have lymphoma or multiple myeloma (MM), whose cells mobilize poorly, and who have~     undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up~     to and including 2012.~      The EBMT is a non-profit, scientific society representing more than 600 transplant centers~     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation~     or cellular therapy, which includes registering all the activity relating to stem cell~     transplants. Data are entered, managed, and maintained in a central database with internet~     access; each EBMT center is represented in this database.~      The analysis of data from a well established registry like the EBMT registry allows for~     follow up of a large number of patients who are representative of the patient population~     receiving plerixafor.~   "
129302|NCT01362959|"~     The purpose of this study is to determine whether transdermal nicotine replacement therapy~     is safe and effective for treating nicotine withdrawal symptoms in the critically ill~     smoking patient.~   "
129303|NCT01362946|"~     The purpose of this study is to modify behavior therapy so that it is optimized for children~     with conduct problems and callous-unemotional traits by emphasizing reward components and~     de-emphasizing punishment components.~   "
129304|NCT01362933|"~     Treatment of venous thromboembolism in cancer patients is specific and has been validated in~     trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K~     Antagonist) treatment during 6 months. International recommendations have diffused this~     option.It is necessary to evaluate the compliance of physicians to this treatment by~     measuring the number of patients with cancer treated with long term use of LMWH.~   "
129305|NCT01362920|"~     In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with~     other laboratory markers to aid in the risk assessment of critically ill patients with~     severe infection (sepsis). Although considerable literature exists regarding the usefulness~     of Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT~     measurements that are not yet explored and its value among the critically ill patients~     remains unclear. This study seeks to better understand the usefulness of measuring PCT~     values in patients admitted to the Medical ICU for a variety of reasons and in particular~     with severe infection (sepsis).~   "
129306|NCT01362907|"~     The purpose of this trial was to compare the performance of an investigational daily~     disposable contact lens to a commercially available daily disposable contact lens.~   "
129307|NCT01362894|"~     The purpose of this trial was to compare the performance of two contact lenses commercially~     available for people with astigmatism.~   "
129308|NCT01362881|"~     It is current practice for children who have surgery for early onset scoliosis (EOS) to be~     treated with insertion of extendable implants known as growth rod systems. This allows the~     growth potential of the child to be maximised during the period of growth. However, the~     child must undergo an average of 6 further surgeries to lengthen the rods every 6 months.~     Sometimes this may continue for several years. This requires repeated general anaesthesia~     and places the patient at risk of complications as well as on-going costs to the hospital~     with each admission and theatre episode.~      Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is~     inserted in exactly the same way as the conventional growth rod systems. The base implants~     i.e screws and hooks remain the preferred choice of the user. The only change is that a~     different rod is used.~      There are several advantages to this device. Firstly, after the initial insertion, further~     lengthenings, unlike current systems, do not need to be carried out in theatre under a~     general anaesthetic. In contrast, they can be done in an outpatients setting with a~     non-invasive technique. The rods are lengthened using an external magnetic device. The~     lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the~     change from a theatre based intervention to an outpatient procedure will have cost-savings.~     The investigators also believe that there will be psychosocial benefits to the child and~     family by the avoiding the stress associated with repeated surgery at such a young age.~      In terms of risk assessment the device does not place the child at any more risk than would~     be expected from inserting any of the existing systems. In the event of failure of the rods~     the worst outcome is a revision to conventional rods.~   "
129309|NCT01362868|"~     The purpose of this study is to investigate the investigational device capacity to detect an~     intraocular pressure increase (IOP)induced by water intake.~   "
129310|NCT01362855|"~     The purpose of the study is to inform decision-makers of the best strategies to implement~     advanced care planning (ACP).~      An advanced care plan (ACP) is a verbal or written instruction describing what kind of care~     an individual would want (or not want)if they are no longer able speak for themselves to~     make health care decisions.~   "
129311|NCT01362842|"~     The lung cancer is the most has the life minacity in all kinds of cancers, and it also~     remains the most common cause of cancer-related death in the world. The group of lung cancer~     patients are suffer from huge disease impact that came from high mortality. Not only the~     course of treatment that patients has been diagnosis through operation is more faster, but~     also those who could be capable of operated are stabilized to keep follow-up at out-patient~     clinic. But in the next following five years after operation, they may take different~     dysfunctional level or some kinds of symptom distress. The effect has a great influence on~     those patients that have to face extended emotional impact, symptom distress and life style~     change. In addition, most of them concern about recurrent all the time in the remission.~     These situation needs us to place importance on it.~      The purposes of this study are to investigate psychological and physical distress and care~     needs in operable lung cancer patients receiving surgery. This survey includes two parts of~     physical and mental condition. First, the investigators are scoring their symptom severity~     and quality of life to check physical condition. Seconded, the mental condition will use~     validated questionnaires to realize the relationship of anxiety, depression, uncertainty,~     fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients'~     needs.~      This study is a cross-sectional designs with convenience sampling that conform to the~     investigators recruited requirements. The investigators will recruit from the clinic of~     thoracic surgery in one medical center in Taipei and take five structured requirements. And~     the investigators are going to collect data from January, 2011 to December, 2012. Also~     expect results are lung cancer outpatients after surgery that more physical dysfunction or~     more depress of mental condition, it will lead patients' needs increased or significant~     difference. In conclusion, this study analyzes their needs in the remission that~     consequences can be medical professionals' reference material.~   "
129312|NCT01362829|"~     The investigators perform a prospective observation study to search for the outcome~     predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.~   "
129313|NCT01362816|"~     The rising incidence of cancer and the rapidly increasing number of people living longer~     with incurable disease, accentuates the need for optimal symptom management throughout the~     disease trajectory. Thanks to the medical and technological development, and the increased~     interest in palliative care research, palliative medicine has gradually become more evidence~     based. Patients with advanced cancer experience multiple symptoms at the time with~     fluctuating intensity and severity. Pain, fatigue, nausea/vomiting, dyspnea, loss of~     appetite and depression are among the most common and experienced by more than 50%. However,~     the prevalence rates of these symptoms vary considerably across studies, with a range from~     35 to 90 % for pain as an example. These differences may in part be explained by different~     assessment tools, study methods and design and population characteristics. There is also~     lack of agreed-upon, common criteria to describe the main characteristics of a palliative~     care cancer population and few standardized tools for assessment and classification of~     symptoms exist. These shortcomings limit the possibility to design randomized controlled~     treatment trials in palliative care; the optimal way to improve clinical symptom management.~     To do this, a better understanding of how symptoms evolve and how they should be assessed~     and classified throughout the palliative care disease trajectory is important, supplemented~     with registrations of the treatment provided. The primary aim of this international research~     project the European Palliative Care Cancer Symptom study (EPCCS) is to extend the knowledge~     about and gain new insight in the prevalence and development of the most frequent cancer~     related symptoms during the course of disease, in a large sample of palliative care cancer~     patients. The clinical usefulness of the new assessment and classification system developed~     by the European Palliative Care Research Collaborative (EPCRC) / European Association for~     Palliative Care Research Network (EAPC RN) will be examined and data on the organization and~     delivery of palliative care at participating centers will be collected. The project also~     aims to further develop and consolidate international research collaboration through the~     European Palliative Care Research Centre (PRC). Taken together, these efforts will increase~     the understanding of the palliative disease trajectory and provide necessary knowledge and~     structure for future randomized controlled trials (RCTs)~   "
129314|NCT01362803|"~     Background:~      - Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat~     them is with surgery. Some of these tumors cannot be completely removed. The tumors may be~     too large, too numerous, or in a bad location for surgery. An experimental drug called~     AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their~     growth, or shrink them. This drug has been tested in adults with cancer and in children with~     some types of brain cancer. This study will test how well this drug works with these types~     of tumors.~      Objectives:~      - To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young~     adults with plexiform neurofibromas that cannot be completely removed by surgery.~      Eligibility:~      - Children and young adults between 12 and 18 years of age who have plexiform neurofibromas~     that cannot be completely removed by surgery.~      Design:~        -  Patients will be screened with a physical exam, medical history, blood tests, and~          imaging studies.~        -  They will take the study drug twice a day with 8 ounces of water, every day for 28-day~          cycles of treatment. During study visits, participants will have blood and urine tests~          and physical exams. They will also have imaging studies to examine the tumor sizes and~          locations. They will answer questions about their health. They may have other tests as~          needed.~        -  Participants will continue to receive the study drug as long as they have no severe~          side effects and the disease is not getting worse.~   "
129315|NCT01362790|"~     Background:~        -  Malignant mesothelioma is a form of cancer that develops on the protective lining that~          covers the body s internal organs. It most often occurs on the lining of the lungs and~          chest wall or the lining of the abdomen. There is no known cure for malignant~          mesothelioma, so researchers are searching for new ways to treat it.~        -  Mesothelin is a protein that is found in mesothelioma and other types of cancer cells.~          An experimental cancer drug called SS1P is designed to attack cells that have~          mesothelin while leaving healthy cells alone. Researchers want to test how effective~          SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help~          suppress the immune system and may make the SS1P more effective.~      Objectives:~      - To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat~     malignant mesothelioma.~      Eligibility:~      - Individuals at least 18 years of age who have malignant mesothelioma in the chest or~     abdomen.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~          They will also have imaging studies.~        -  The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment~          will follow.~        -  In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will~          have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.~        -  On the next three cycles, participants will have pentostatin on day 1.They will have~          cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.~        -  Participants will have frequent blood tests and other studies. They will receive all~          four cycles of treatment as long as there are no severe side effects.~        -  Participants will have regular followup visits as directed by the study doctors.~   "
129316|NCT01362777|"~     The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the~     general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is~     associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes.~     OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS~     patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at~     least 30% of traffic accidents but also other cognitive disorders with significant impact on~     quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and~     other systemic metabolic dysregulation of many whose levels are correlated with the severity~     of the disease.~      Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its~     effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept~     and/or poorly tolerated, limiting its effectiveness.~      Weight loss and regular physical activity are clearly recommended but rarely done in~     clinical practice. A few studies have applied to study the effects of rehabilitation~     training (REE) on the sleep apnea patients and have shown an improvement in sleep quality,~     reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but~     their methodology was questionable, and the number of patients included was too low.~      The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program~     comprising educational activities, dietary management and individualized exercise training~     (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL).~     This IET program (24 sessions during 4 weeks) could also help to improve many metabolic~     dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk).~     Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory~     control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to~     leptin may play a role in enabling a better control of ventilation in these patients.~   "
129319|NCT01362738|"~     The purpose of this prospective randomized study is to assess whether empirical Left Atrial~     Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI)~     and ablation of extra-pulmonary triggers is superior to the standard approach alone in~     enhancing the long-term success rate of catheter ablation in persistent or long-standing~     persistent atrial fibrillation (AF) patients.~   "
129320|NCT01362725|"~     The primary objectives of this feasibility study are to determine the safety of spinal cord~     stimulation (SCS) as a therapy in patients with systolic heart failure and to gather~     observational information for potential efficacy markers~   "
129321|NCT01362712|"~     This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an~     exploratory Phase I trial designed to collect information as this IP is administered and~     evaluated for the first time in humans. The trial will evaluate safety, biodistribution and~     dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and~     tumor to background imaging data, and correlate image data with caspase 3 activity level on~     a surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study~     results will be evaluated and analyzed in order to consider the design for future clinical~     trials. The information collected under this exploratory, Phase I study will not be used for~     diagnostic purposes, to assess the subject's response to therapy, or for clinical management~     of the subject.~   "
129322|NCT01362699|"~     The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the~     urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.~   "
129323|NCT01362686|"~     Conduct a comparative effectiveness clinical trial of medication treatment for behavioral~     symptoms of Alzheimer's disease in a group of real-world memory care clinics with enhanced~     access to the Indiana Network for Patient Care.~   "
129324|NCT01362673|"~     This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed~     to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of~     PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed~     conditions.~   "
129325|NCT01362660|"~     This study will examine post-natal neurologic and cognitive development of infants who may~     have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program~     (whether the exposure is through maternal or paternal participation in a tanezumab clinical~     study).~   "
129326|NCT01362647|"~     Several studies have documented that neuromuscular block often persists in the~     postanesthesia care unit (PACU). Residual paralysis is associated with postoperative~     complications such as hypoxia, weakness, and respiratory failure. The data in the current~     literature on residual paralysis in the PACU were almost exclusively obtained with~     acetylcholinesterase inhibitors as they were the only reversal agents available prior to the~     introduction in clinical practice of sugammadex (Bridion®) in the European Union and in some~     other countries, except for the USA. Reassessment of practice in this regard is relevant,~     now that sugammadex (Bridion®) has become available in our country since 2009.~      This study is an observational/non-interventional, non-randomized study involving adult~     patients undergoing different types of elective surgical procedures requiring general~     anesthesia with neuromuscular blocking drugs (NMBDs). Administration of NMBDs and reversal~     agents (as well as all drugs which will be used during anesthesia) will be performed in~     accordance with routine anesthetic practice.~      The study population will comprise about 600 surgical patients. Immediately after the~     patients' arrival in the PACU, a study nurse will record the acceleromyographic responses of~     their adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the~     ulnar nerve. A TOF of 90% will be used as cut-off value to exclude residual paralysis. Pulse~     oximetry (SpO2) will be measured continuously throughout the PACU admission, and SpO2 values~     will be recorded at 1-min intervals for the first 30 min. PACU nurses caring for the patient~     will document the occurrence of any of the following events during the first 30 min of PACU~     admission: the number of episodes of hypoxemia (SpO2<90%), the lowest SpO2 observed by~     nursing staff, the requirement for either tactile or verbal stimulation to maintain SpO2~     greater than 90%, and any clinical evidence of airway obstruction.~      The primary objective is to evaluate the incidence of postoperative residual curarisation at~     PACU arrival in patients reversed with sugammadex (Bridion®), neostigmine and in case of~     spontaneous recovery.~      The secondary objectives are to evaluate:~        -  Oxygen saturation (SpO2) at PACU arrival~        -  Possible episodes of SpO2 <90% in the PACU~        -  Airway maneuvers and/or stimulation required to maintain SpO2 >90% in the PACU~        -  Need for re-intubation.~   "
129327|NCT01362634|"~     The proposed study is a three-armed randomized clinical trial. A total of 750 clients will~     be randomly assigned (using a random number table) to the interviewer-administered~     intervention, the self-administered intervention, and waitlist control conditions upon~     completion of screening, informed consent, HIV pretest counseling and test administration,~     and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12~     months.~   "
129328|NCT01362621|"~     The study was designed to collect data about inadequately controlled moderate to severe~     allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.~   "
129329|NCT01362608|"~     The purpose of this pivotal Phase III study is to support the registration of canakinumab~     for the indication of gout in China, a replicate of global studies CACZ885H2356 &~     CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs~     and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c.~     given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout~     flares compared to triamcinolone acetonide 40 mg i.m.~   "
129330|NCT01362595|"~     This study will determine the safety and possibility of giving the amino acid, leucine, in~     patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell~     transfusions.~      The leucine is expected to produce a response in patients with DBA to the point where red~     blood cell production is increased. Red cell transfusions can then be less frequent or~     possibly discontinued.~      The investigators will study the side effects, if any, of giving leucine to DBA patients.~     Leucine levels of leucine will be obtained at baseline and during the study.~      The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9~     months.~   "
129331|NCT01362582|"~     A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic~     adenocarcinoma receiving defined second or higher line chemotherapy and additionally~     parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).~   "
129341|NCT01362452|"~     The goal of this clinical research study is to learn if an infusion of white blood cells~     (called T cells) that have been genetically changed is safe to give patients who have~     received an UCBT. Researchers want to learn if these genetically changed T-cells are~     effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia~     after they have received an UCBT, how long the changed T-cells stay in the body, and if~     adding them to standard transplant could improve how patients respond to treatment.~      Funding Source - FDA OOPD~   "
130887|NCT01342211|"~     This study will investigate the effect of PF-04950615, a new investigational lipid lowering~     agent, on LDL-C and other lipids.~   "
129332|NCT01362569|"~     Chronic kidney disease is widespread in the western world with bacterial infection and~     sepsis as common complication. It has been shown that innate immune defence, represented by~     dysfunction of neutrophil granulocytes, is impaired in chronic kidney disease. Another~     impact of chronic kidney disease on innate immunity is the chronic activation of neutrophils~     leading to high levels of inflammatory cytokines, thus contributing to protein oxidation.~     Oxidation of human serum albumin (HSA), the major plasma protein, occurs in chronic kidney~     disease and leads to further activation of neutrophils. Another important impact of HSA~     oxidation is the decrease of its binding capacity leading to impaired detoxification ability~     of albumin. This includes reduced clearance of endotoxin, a major component of the gram~     negative bacterial cell wall. Circulating endotoxin is recognized by complex formation with~     lipopolysaccharide binding protein (LBP) followed by binding to CD14 and toll-like receptor~     (TLR) 4. High systemic endotoxin levels occur in chronic kidney disease and may be the~     result of decreased clearance ability of HSA and increased gut permeability in combination~     with intestinal bacterial overgrowth. High systemic endotoxin is associated with worse~     outcome in several diseases and could be used as predictor for mortality in chronic kidney~     disease patients.~      Endotoxemia in renal insufficiency leads to impaired neutrophil function and to increased~     albumin oxidation. Oxidized albumin is not able to bind endotoxin adequately any more, which~     leads to a further increase in oxidative stress and neutrophil dysfunction, resulting in a~     vicious cycle.~      195 patients with renal dysfunction will be enrolled and divided into 5 groups.~     Additionally, samples of 25 age and sex-matched healthy controls will be collected.~      This concept will change the understanding of several aspects of chronic kidney disease and~     will potentially help to stratify patients into different groups at risk according to their~     endotoxin status, and their immune and albumin dysfunction. The results of this study will~     have important implications into the development of novel therapeutic strategies~   "
129333|NCT01362556|"~     The debate over the administration of sodium bicarbonate in cardiac arrest has been going on~     for several decades, swinging like a pendulum from first-line drug to not indicated to~     the recent guidelines advocating a small bolus under special conditions (metabolic~     acidosis, intoxication, long-term resuscitation). A targeted, blood-gas controlled~     application under optimised ventilation conditions has not yet been evaluated prehospitally.~     Our preliminary studies have shown that an arterial puncture/line as well as measurement of~     blood gases is feasible in preclinical conditions. This multicentre trial including 5~     centres and 10 physician-staffed emergency systems is designed to compare, in a prospective~     randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based~     on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and~     on the secondary survival of cardiac arrest patients. The null hypothesis is that there is~     no or negative impact on survival.~   "
129334|NCT01362543|"~     The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment~     of traumatised refugees. There is a lack of studies on treatment effect in traumatised~     refugees. There are several studies indicating an effect of cognitive behavioural therapy~     (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be~     effective in traumatised refugees. There are no studies examining if some methods used in~     CBT are more useful than others in traumatised refugees. The aim of this study is to examine~     the effect of CBT with focus on Stress Management versus cognitive restructuring. Patients~     included in this study will be randomised to either Stress Management or cognitive~     restructuring. All referred patients will receive medical treatment as usual (described in~     the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion~     criteria will be included in the study. Hopefully this study will contribute to improve the~     psychotherapeutic treatment offered to traumatised refugees.~   "
129335|NCT01362530|"~     This study will compare the safety and efficacy of a three-day oral aprepitant regimen~     (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced~     nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in~     pediatric participants. Those who complete this first cycle of treatment and meet certain~     eligibility criteria will have the option of continuing for 5 additional cycles of~     open-label aprepitant.~   "
129336|NCT01362517|"~     The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine~     (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H.~     influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4~     months of age according to the local Expanded Programme on Immunisation (EPI) schedule~   "
129337|NCT01362504|"~     The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level~     in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this~     study. Eighty healthy matched neonates served as a control group.~   "
129338|NCT01362491|"~     This study will compare the ability of a single-dose of a novel ibuprofen formulation to~     relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type~     headache~   "
129339|NCT01362478|"~     Schizophrenia is a disabling mental disease affecting about 1% of the worldwide population.~     There is an overall heritability estimate of 68% for the underlying liability to~     schizophrenia. Molecular epigenetic studies can overcome the complexities of traditional~     genetic studies and provide a new framework for the search of etiological factors in~     schizophrenia.~      DNA methylation provides an example of an epigenetic process that affects gene expression.~     Several postmortem experiments have found that increased DNA methylation at the glutamic~     acid decarboxylase (GAD67) and reelin promoter, and hypomethylation of membrane-bound~     catechol-O-methyltransferase (MB-COMT) promoter gene in prefrontal cortex of schizophrenia~     patients.~      Because it is impossible to obtain brain tissue from schizophrenia patients clinically, the~     peripheral blood mononuclear cell (PBMC) can partly represent the brain gene expression. It~     has been reported to use PBMC as biomarkers for epigenetic abnormalities, such as histone~     acetylation and methylation, in schizophrenia. To the investigators best knowledge, gene~     promoter DNA methylation abnormalities in schizophrenia have been limited to postmortem~     study. It warrants to studying the DNA methylation using schizophrenia's PBMC.~      Recently, endophenotype strategy has emerged as an important tool in understanding the~     genetic architecture of schizophrenia. Some cognitive functions, such as attention and~     working memory (WM), have been used as candidate endophenotypes for genetic studies in~     schizophrenia. Synchronized GABA neurotransmission in the dorsolateral prefrontal cortex is~     required for adequate attention and working memory, suggesting that impairments in~     GABA-mediated inhibition in the prefrontal cortex could contribute to the endophenotype~     presentations in schizophrenia.~   "
129340|NCT01362465|"~     This study is an effort to use left ventricular (LV) lead based measurements to identify~     late electrical activation and avoid scar.~   "
129365|NCT01362140|"~     The primary objective was to assess the superiority of darbepoetin alfa versus placebo on~     the incidence of red blood cell transfusions during the 24-week double-blind treatment~     period in anemic patients with low or intermediate-1 risk MDS.~   "
129342|NCT01362439|"~     The purpose of this study is to evaluate the effectiveness and safety of paliperidone~     extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self) who were receiving treatment with any oral~     (having to do with the mouth) antipsychotic medication and who needed to be switched to~     paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or~     due to side effects.~   "
129343|NCT01362426|"~     The primary objective of this study is to determine if Australian patients with~     schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring~     of outcomes over a 12-month period achieve relapse rates comparable to published literature.~   "
129344|NCT01362413|"~     The aim of the study is to determine whether the evaluation of pro-osteogenic activity of~     autologous serum may predict the effectiveness of platelet gel in regenerating bone tissue~     in patients with nonunions of long bones.~      Serum samples will be collected before the surgery, and their pro-osteogenic activity will~     be evaluated by using a bioactivity test (mineralization assay).~      In order to determine whether the pro-osteogenic activity of the serum is able to~     discriminate between individuals who will achieve or will not achieve bone consolidation,~     the laboratory results will be correlated with clinical and radiographic results at 12~     months, when patients will be considered as healed or not healed.~   "
129345|NCT01362400|"~     The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel~     to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell~     Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of~     the study is to determine the effect of IPI-504, in combination with docetaxel, verses~     placebo in, combination with docetaxel, on the growth of cancer~   "
129346|NCT01362387|"~     Purpose: This randomised trial will compare outcomes and acceptability of an alternative~     medical abortion follow-up protocol using standardised text messaging, on-line~     questionnaire, or a phone interview and a low sensitivity pregnancy test with the current~     standard of care which consists of either a clinic visit and ultrasound scan or a telephone~     call and high sensitivity pregnancy test.~      Hypothesis: The use of alternative methods to assess outcomes after early medical abortion~     will achieve a higher rate of follow-up than women undergoing standard follow-up~      Primary aim: To determine the follow-up rate after early medical abortion with an~     alternative protocol as compared to a standard follow-up protocol~      Secondary aims:~        -  To assess complication rates and receipt of further treatment among women in the two~          study arms~        -  To ascertain women's preferences for mode of communication regarding their post-medical~          abortion status~        -  To determine provider opinions and preferences for different follow-up modalities~   "
129347|NCT01362374|"~     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics of oral GDC-0068 administered in combination with~     either docetaxel, mFOLFOX6, paclitaxel or enzalutamide in patients with advanced or~     metastatic solid tumors for which standard therapy either does not exist or has proven~     ineffective or intolerable.~   "
129348|NCT01362361|"~     The purpose of this study:~      To explore the comparative effectiveness of BIBF 1120 in terms of :~        -  Progression-free survival (PFS), objective response, overall survival~        -  Evaluate and compare safety~   "
129349|NCT01362348|"~     The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a~     single dose regimen of pazopanib eye drop for neovascular AMD.~   "
129350|NCT01362335|"~     In many surgical procedures, anaesthesiological care is provided according to the best~     scientific and clinical information available. However, since hemodynamic monitoring until~     recently did not allow for beat-to-beat information of the haemodynamical changes, many~     fast-changing events may have been unnoticed or have not been investigated as precisely as~     is possible today. Moreover, in several surgical procedures - like eye surgery - the~     invasiveness of the classical haemodynamical monitoring devices was of such a degree that~     until now, in these circumstances these vital parameters were not investigated yet.~      Therefore, the availability of this new device, which allows for noninvasive beat-to-beat~     assessment of these haemodynamical parameters gives a unique opportunity to investigate our~     anaesthesiological management and to elucidate whether improvements are desirable and~     possible.~      The Nexfin monitor consists of a cuff-micromanometer that is located around the third~     finger. It simultaneously uses continuous pressure readings and light-absorption~     spectrometry to determine valuable haemodynamical information. Data is recorded and~     available for subsequent offline analysis.~   "
129351|NCT01362322|"~     The purpose of the study is to compare the immunogenicity and safety of a booster dose of~     BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in~     the previous syringe presentation in healthy adolescents aged 10-15 years.~   "
129352|NCT01362309|"~     There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form~     of dysregulated learning and are influenced by classical conditioning. This is based on~     numerous studies indicating that conditioned contextual cues influence craving for alcohol~     consumption. As a result, there has been considerable interest in extinction-based~     treatments for AUDs (i.e., treatments that focus on extinguishing the associations between~     alcohol cues and motivation to drink), referred to as cue exposure treatment To date,~     extinction-based treatment for AUDs has resulted in disappointing outcomes in clinical~     trials and there is considerable interest in improving this form of treatment. One novel~     strategy is the use of pharmacological adjuncts to enhance extinction. Medications that~     maximize extinction may minimize subsequent reactions to alcohol cues and, in turn,~     subsequent clinical outcomes. This study is examining whether the medication d-cycloserine~     (DCS) can enhance extinction to alcohol cues. Recent basic research has revealed that DCS~     enhances extinction to fear cues and several lines of evidence suggest that DCS may also~     enhance extinction to alcohol cues. Therefore, DCS may serve as a useful pharmacological~     adjunct to extinction-based treatment for AUDs. Our primary aim is to examine whether,~     compared to placebo, DCS (50 mg) will enhance extinction to alcohol cues under controlled~     laboratory conditions in treatment-seeking individuals with alcohol use disorders. We~     hypothesize that DCS will generate greater extinction compared to placebo during the~     subsequent extinction session as measured by attenuated craving in response to alcohol cues.~     Furthermore, we hypothesize that DCS will generate greater extinction compared to placebo at~     follow-up assessments. This study is a proof-of-concept test of whether DCS can reduce~     reactions to alcohol cues under controlled laboratory conditions. It is a preliminary study~     using a subclinical number of extinction sessions and medication administrations to~     establish whether or not DCS improves extinction in the laboratory. If proof-of-concept is~     supported, it will suggest that a clinical trial is warranted. A clinical sample and~     clinical context are used to maximize the potential generalizability from this exploratory~     study.~   "
129366|NCT01362127|"~     The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a~     higher degree of complete histological response than neoadjuvant chemotherapy before surgery~     in patients undergoing treatment for cancer of the esophagus or cardia.~   "
130905|NCT01341977|"~     The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone~     hydrogel and soft hydrogel contact lens wearers.~   "
129353|NCT01362296|"~     This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and~     safety of GSK1120212 compared with docetaxel in the second line setting for subjects with~     locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a~     KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset~     of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to~     the primary KRAS population, for exploratory purposes.~   "
129354|NCT01362283|"~     The purpose of this study is investigating the proportion of Cardiovascular disease risk~     factors of hypertensive patients.~   "
129355|NCT01362270|"~     BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical~     ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is~     helping a patient breathe if he can't breathe on his own. Because of the mechanical~     ventilation, these patients also require some medication to help keep them calm. These are~     called sedatives or anxiolytics.~      The purpose of this study is to see if acupuncture can lower the amount of sedation and~     anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a~     medical procedure. Hair-thin sterile needles are inserted at specific points on the body.~      PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By~     using 'fake' acupuncture, no one other than the acupuncturists will know which group a~     subject is in. Subjects and the team do not get to pick which subject is in which group.~     Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a~     day for five days.~      Standard of care - Both groups will receive the standard of care while in the study. They~     will be mechanically ventilated and given sedatives and analgesics based on the TICU~     protocol.~      Real acupuncture group - This group will receive real acupuncture with real needles. These~     are stainless steel, one time use, needles. This group will also receive ear tacks which~     are like little needles that can stay on the ear for a few days. The ear tacks will be~     covered with a bandage so no one can tell which group the subject is in.~      Sham acupuncture group - This group will receive sham needles. These needles retract into~     themselves much like a 'magic sword' rather than poking the skin. Subjects in this group~     will not get ear tacks. In order to hide the group the subject is in, a bandage will be used~     to cover part of the ear.~      HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when~     compared to the sham acupuncture group.~   "
129356|NCT01362257|"~     This will be a two-period, open-label study conducted at a single site. Six healthy male~     subjects will participate in the study to ensure at least four fully evaluable subjects.~     Each subject will receive a single 1000 μg (microgram) oral dose containing 50 μCi (Micro~     Curie) of [14C]-GSK573719 and a 65 μg intravenous infusion containing 7.1 μCi of~     [14C]-GSK573719. Whilst subjects are in-house, urine and faecal samples will be collected~     for a minimum of 168 hours (7 days) after dosing or for up to 240 hours (10 days) depending~     on the amounts of radioactivity still being excreted after Day 5. Faecal sample collection~     may continue at home for up to 14 days. Bile samples will be collected using Entero-Test~     string sampling of duodenal bile. Whole blood and plasma samples will be collected at~     various sample times after dosing to measure parent drug (plasma only) and total~     radiolabelled drug related material (blood and plasma). Urine and faeces aliquots will be~     taken to measure total radiolabelled drug-related material. Samples of urine, faeces and~     plasma will be transferred into a separate study to characterize and, where possible,~     quantify metabolites in these matrices.~   "
129357|NCT01362244|"~     A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate~     the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe~     bilateral nasal polyposis.~   "
129358|NCT01362231|"~     The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind,~     placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with~     Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.~      Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in~     subjects with IPF and is currently enrolling.~   "
129359|NCT01362218|"~     This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the~     cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril)~     as compared to the effect on LDL cholesterol of the reference products (simvastatin,~     ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized~     in order about 238 subjects to finish the study.~   "
129360|NCT01362205|"~     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of~     dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol~     withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults.~      The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual~     therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol~     withdrawal delirium/delirium tremens (AWD) in critically ill adult patients will reduce the~     time to resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days~     in the first 28 days of hospitalization, reduce the length of ICU and hospital stays, and~     improve neurocognitive and quality of life scores on hospital discharge.~   "
129361|NCT01362192|"~     The purpose of this study is to evaluate the safety and effectiveness of a new laser for the~     removal of unsightly spider veins on the legs. The device used in this study is the Cutera~     Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064~     nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received~     510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological~     and vascular conditions, like spider veins.~   "
129362|NCT01362179|"~     This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized~     peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis~     that the incidence of targeted malignant, thrombotic and autoimmune disorders after~     unrelated hematopoietic stem cell donation are similar between unstimulated BM and~     filgrastim-mobilized PBSC donors.~   "
129363|NCT01362166|"~     The main purpose of this study is to detect the frequency response in the electric wave~     transmission through the channels inside human body. With the electric signals in different~     frequencies, analyzed by the digital signal processing technique, the adaptability of the~     channel for different frequencies may be revealed. With this study there will be a feasible~     connection between the physiological signals and the channel theory in Chinese medicine, and~     the basis of the physiological signals can be drew out for the description of the internal~     organs, the strong or weak, the truth or falsity.~      The Zu-San-Li is the open acupoint on foot-Yangming channel, the stomach channel. Qi, the~     main concept in TCM, will flow from the open acupoint to go into deep internal organs.~     Xian-Gu is another Yu acupoint on foot-Yangming channel. The inborn original Qi flows from~     the Yu acupoint infuse into blood vessels. So in this study the investigators will take~     these two acupoints for the acupuncture. Since the direction of the channel is from~     Zu-San-Li to Xian-Gu, the investigators pick Zu-San-Li as the input and Xian-Gu the output~     for the electrical signals.~      For this experiment, the investigators planned enrolling 30 male sub-healthy volunteers,~     aged in 20-35 years old, to finish the whole experiment procedures.~      After the acupuncture, the electric signals of different modes will be input from the~     subject's open acupoint (Zu-San-Li), and measure the frequency respond voltage from the~     output acupoint (Xian-Gu).~      Each subject must complete the acupuncture of Zu-San-Li and Xian-Gu, and be input 5 sets of~     the electric signals of different modes two times on the trial. The variety conditions of~     the wave form and electric voltage will be recorded and measured respectively.~      The investigators plan to obtain the data in six months, and complete the data analysis and~     sorting in two months.~   "
129364|NCT01362153|"~     This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous~     administered golimumab in patients with rheumatoid arthritis.~   "
129368|NCT01362101|"~     This study is ancillary. Participants will be recruited as part of a separate clinical trial~     on effects of two intensive behavioral training programs that evaluates feasibility and~     efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison~     to traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to~     compare the effect of MT to that of traditional CBT on a physiological marker of stress,~     salivary cortisol concentration, and physiological responses to smoking cues in tobacco~     smokers. The investigators will use electrophysiological reactivity to smoking cues in the~     form of audio recordings of personalized scripts describing the scenarios associated with~     the strongest urges to smoke that will provide a physiological validation to a behavioral~     intervention. The investigators will also explore correlations between these biological~     markers and self report of stress, craving and negative affect to supplement self report and~     behavioral outcome measures with biological and physiological markers to represent~     improvement attributed to the intervention.~   "
129369|NCT01362088|"~     In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous~     Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From~     there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate,~     the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are~     subsequently randomly analyzed, and the sublingual microcirculation is expressed as a~     number, the microvascular flow index (MFI).~   "
129370|NCT01362075|"~     The purpose of this study is to determine the efficacy of local infiltration analgesia as~     compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The~     investigators hypothesize a reduced pain score and use of supplemental analgesic medication~     during the first three postoperative days using local infiltration analgesia.~   "
129371|NCT01362062|"~     This observational study will evaluate the safety, tolerability and efficacy of tocilizumab~     in participants with moderate to severe RA who have an inadequate response to current~     non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant~     during tocilizumab therapy and on follow-up for a total of 12 months.~   "
129372|NCT01362049|"~     The research objective is to determine which physical therapy (PT) treatment is the most~     efficacious for patients with lower back pain (LBP), who have been subgrouped based on~     certain clinical features. There is only limited evidence that supports any one PT treatment~     for patients with LBP since PT treatment outcomes for exercise protocols are equivocal,~     given the heterogeneous clinical features of patients with LBP. Thus, classification of~     patients with LBP into subgroups with shared clinical features has been identified as a~     research priority by several groups in order to prescribe the most efficacious PT treatment~     for each homogeneous subgroup. The investigators hypothesize that particular PT treatments~     are most efficacious when applied to patients with LBP, who present with particular clinical~     and neuromuscular features.~   "
129373|NCT01362036|"~     Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3~     design study involving at least 3 subjects in ascending dose cohorts, with subjects~     participating up to 10 weeks.~      The overall study objectives are to evaluate the safety and tolerability of TXA127 in~     thrombocytopenic subjects with low or intermediate-1 risk MDS.~      Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127~     will provide preliminary efficacy data.~   "
129374|NCT01362023|"~     Our hypothesis is that a regular systematic educational intervention in primary school~     improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate~     the effects of a 3-year school-based program of lifestyle improvement, including diet and~     physical activity, implemented by university students acting as health promoting agents~     (HPA) on the prevalence of obesity.~   "
129375|NCT01362010|"~     The purpose of this study is to evaluate the tolerability and safety and to determine~     whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.~   "
129376|NCT01361997|"~     The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior~     preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70%~     isopropyl alcohol.~   "
129377|NCT01361984|"~     This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The~     investigators plan to enroll about 20 subjects who are at least 40 years old and have~     Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the~     effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the~     investigators are looking at how much and for how long the two drugs can open up the small~     airways in the lungs. This will be done with breathing tests on all subjects, and with high~     resolution CT scans on subjects who agree to this optional part of the study. Half of~     subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then~     Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take~     Serevent the first two weeks and Brovana the second two weeks. All subjects will also take~     Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms.~     After a Screening Visit to determine eligibility, subjects will be randomly assigned to~     receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the~     other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include~     questionnaires, review of health and medications, and breathing tests before and after~     taking the study drug. Subjects who agree to be in the sub-study will also undergo CT scans~     before and after taking the study drug at both test visits.~   "
129378|NCT01361971|"~     Obesity is an epidemic in Western society and is the biggest risk factor for insulin~     resistance and type 2 diabetes. The investigators have preliminary evidence showing that~     hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires~     confirmation in a larger population, and with this study the investigators will also test~     for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and~     stress response proteins following changes in tissue oxygenation may contribute to these~     improvements. This study has the potential to yield new and important insights into the~     insulin resistance in obesity.~   "
129790|NCT01356576|"~     The purpose of this study is to determine if there is a drop in platelet count after~     hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in~     platelets and sometimes in white blood cells. The investigators are going to study one of~     the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.~   "
129379|NCT01361958|"~     The aim of the present study was to evaluate the ability of several doses of NOMAC in~     combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and~     ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer~     premenopausal women.~      The study was also designed to check whether the combined administration of E2 and NOMAC at~     the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to~     when it is given alone.~   "
129380|NCT01361945|"~     The purpose of this study is to find out what effects, administering infusions of AUY922~     with hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the~     patients with advanced breast cancer known as ER+ HER2 +.~   "
129381|NCT01361932|"~     This project will evaluate the effectiveness of 38 videos of discharge instructions for~     patients seen in, and discharged from, the emergency department (ED). The investigators will~     (1) assess how many ED patients chose view the website, and (2) interview patients who~     viewed a video, as well as those who didn't view a video (and therefore received standard~     care), to determine whether patients who viewed a video understood their diagnoses and~     discharge instructions better.~   "
129382|NCT01361919|"~     The goal of this study is to compare three methods of teaching medical and nursing students~     basic life saving skills. The standard method will teach students how to push on the chest~     and to analyze the heart rhythm using a regular monitor. The newer approach will teach the~     same skills but use a special heart monitor that provides both visual and verbal reminders.~     The third approach will combine both the standard and newer approaches to teaching. Our~     study would like to find out the better way to teach these skills and to create a standard~     way to grade how well students perform. This study will measure how deep and how fast the~     students push on the manikin's chest in a certain amount of time. Other goals include~     measuring how well the students use the heart monitor to deliver shocks and analyze the~     heart rhythm, how many breaths per minute they give, how long their hands are off the~     manikin and how well they think they performed overall.~   "
129383|NCT01361906|"~     The purpose of this study is to determine whether sensomotoric training can reduce~     neck/scapular pain in people with visual disability.~   "
129384|NCT01361893|"~     The overall purpose of this investigation is to better understand factors contributing to~     the high incidence of prone sleep positioning in African-American infants. In addition, the~     investigators are interested in investigating other races and ethinicities to understand~     their beliefs and perceptions and determine differences socioeconomically and~     socioculturally within and between groups. The investigators will address the following~     specific aims:~      (-) To compare knowledge, attitudes, and practices regarding infant sleep position in~     parents of higher and lower SES.~      (-) To identify risk factors for non-use of recommended supine sleep position in families~     with higher and lower SES (-) to develop a phenomenologic understanding of the decisions~     made by parents of higher SES and lower SES who do nt use recommended supine sleep position,~     using qualitative techniques.~   "
129385|NCT01361880|"~     The overall purpose of this randomized trial is to develop and evaluate a systematic~     approach to improve African-American parental behaviors specifically with regards to the~     infant sleep environment. African-American parents of newborn, healthy term infants will be~     randomized to receive either a standard message to avoid bedsharing, eliminate use of soft~     bedding and soft sleep surfaces, and to place infants in the supine position for sleep to~     reduce the risk of SIDS or an enhanced message to avoid these behaviors to both reduce the~     risk of SIDS and to prevent infant suffocation.~   "
129386|NCT01361867|"~     The investigators hypothesize that the motor learning processes observed in the lower~     extremity will be similar to those seen in upper arm experiments. Furthermore, the~     investigators hypothesize that lower extremity motor learning can be quantified with an~     adapted model of the force-field adaption paradigm (FFAP) introduced by Shadmehr et al. for~     studying motor learning in the upper extremities.~   "
129387|NCT01361854|"~     Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected~     of sleep-disordered breathing.~      First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with~     the portable monitoring.~      Second one: hook-up is performed home, around 7 PM, and the patient has not to move after~     hook-up.~   "
129388|NCT01361841|"~     Intraocular pressure (IOP) is considered to be the main risk factor for progression of~     glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has~     changed considerably during the last decades due to the introduction of prostaglandin~     analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T,~     Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).~      There have been several studies to evaluate their effectiveness. The three seem to be~     equivalent, according to the only study that has compared the molecules. Latanoprost is~     employed initially, due to its paucity of side effects when compared to the other two~     analogues. However, if it is not effective, several studies ahve shown that a result is~     possible using either travoprost or bimatoprost. No study has been conducted to date~     systematically comparing the three molecules in cases of resistance to latanoprost. In~     actuality, the investigators patients will receive treatment identical to current practice~     with the exception of the group continuing with latanoprost. Several studies confirm the~     benefit of changing prostaglandin analogues if the first has not signficantly decreased the~     IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the~     mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects)~      The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost~     and travoprost in their IOP-lowering capacity in patients who do not initially respond to~     latanoprost.~   "
129389|NCT01361828|"~     The purpose of this study is to investigate the possible affection of optic nerve and~     retinal functions following intravitreal bevacizumab injection in human eyes.~   "
129390|NCT01361815|"~     The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep~     Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake~     Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/~     Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder~     (MDD) (Protocol# CTP-0001-00).~   "
129391|NCT01361802|"~     The development of a new Ambroxol spray formulation for the treatment of sore throat pain~     associated with acute pharyngitis requires an initial phase II study to be conducted in~     order to select the most appropriate dose for pain relief.~   "
129392|NCT01361789|"~     Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID~     or COX-2 selective inhibitor gives better pain relief than either of the drugs used~     separately. The investigators group has also shown that adding dexamethasone on top of a~     regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest~     after ambulatory breast cancer surgery.~      The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The~     investigators want to evaluate whether a selective COX-2 selective inhibitor or a~     glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can~     provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL~     surgery.~   "
129393|NCT01361776|"~     Antibody titers after tick-borne encephalitis (TBE) vaccination are less in elderly and~     vaccination breakthroughs are more common in this age group. This has prompted Swedish~     authorities to recommend an additional dose in the initial vaccination schedule (= 0+30+90~     days instead of the usually recommended 0+30 days. The investigators intend to evaluate this~     regime.~   "
129394|NCT01361763|"~     This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of~     dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety~     trial, and the primary objective is to assess that dabigatran is not less safe than ASA in~     subjects with CADASIL.~   "
129395|NCT01361750|"~     This study is to investigate the effects of narrowed gastric tube on postoperative~     nutritional status and the quality of life in esophageal cancer patients treated with~     Ivor-Lewis esopagectomy in a 12-month follow-up period.~   "
129396|NCT01361737|"~     Could possible markers in serum obtained in the first trimester predict the human-pregnancy~     specific disorder pre-eclampsia?~   "
129397|NCT01361724|"~     Problems with balance and walking that affect mobility are an inevitable cause of decreased~     quality of life in older people with chronic neurologic conditions such as Parkinson's~     disease (PD). Although there is evidence that exercise can improve mobility in the elderly,~     the investigators don't know: 1) What is the best mode of exercise intervention delivery~     (i.e. individual therapy in a clinic, home exercise program, or a group class)? and 2) how~     do other problems common in people with PD and/or the elderly affect outcomes? Although most~     physical therapy is carried out individually, a group or home program would be most~     cost-effective so the investigators need to know if they are just as effective. Since most~     older people with chronic neurologic diseases also have other problems affecting mental~     function, muscles and joints and/or pain, it is important to understand how these other~     problem affect the success of their therapy. The purpose of this study is to investigate how~     PT intervention should be delivered to patients with chronic neurologic disease who also~     have other problems. The investigators will using elderly people with PD who have one or~     more co-morbidities associated with PD and/or aging. Sixty people PD and co-morbidities will~     be randomized into 1of 3 groups; home program, individual PT or group exercise class. Each~     of the 3 groups will be led by the same PT providing a novel sensory-motor agility program~     developed by our laboratory. All groups will perform the same type of exercises 3 X/week for~     4 weeks. Improvement in the Physical Performance Test of disability will be used to~     determine the success of therapy. To determine how and why mobility was improved by therapy,~     changes in gait, balance, and quality of life will be measured. Gait and balance will be~     measured with new, wearable motion sensors (iPOD size) while standing up from a chair,~     walking, turning around and sitting back down. The findings from this study will help guide~     rehabilitation treatment for complex , chronic problems affecting mobility in older people.~   "
129398|NCT01361711|"~     This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab~     together works in treating patients with previously untreated chronic lymphocytic leukemia~     (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in~     different ways. Some block the ability of cancer to grow and spread. Others find cancer~     cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab~     together with ofatumumab may kill more cancer cells~   "
129399|NCT01361698|"~     The aim of this trial is to evaluate the effectiveness of the Illness Management and~     Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to~     their level of functioning.~   "
129400|NCT01361685|"~     Lead survivability will be summarized.~   "
129401|NCT01361672|"~     Lead survivability will be summarized.~   "
129402|NCT01361659|"~     There is an increasing number of patients with a coronary anatomy that does not allow~     additional revascularization procedures, while the patients suffer from angina pectoris at~     rest or at minimal exercise levels despite optimised medical therapy. There is a lack of~     therapeutic options for this group of so called no-option patients. Goal of the project is~     to implement the shockwave therapy for no-option coronary artery disease patients and to~     evaluate its potential benefit on regional myocardial perfusion, on regional myocardial~     function and on the potential improvement in symptoms and quality of life.~   "
129403|NCT01361646|"~     This will be a dose block-randomized, double-blind, active and placebo controlled, single~     and multiple dosing, dose-escalation study to evaluate tolerability, safety and~     pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations,~     vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation~     and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic~     evaluations will be conducted at specified time points.~   "
129404|NCT01361633|"~     The goal of this study is to determine whether a study medication (d-cycloserine) improves~     the ability of older adults to perform on tests of neuropsychological functioning. Tests of~     neuropsychological functioning assess attention, memory, and executive functioning skills~     (for example, problem-solving, planning and organizing skills). It was hypothesized that~     participants who received study medication would perform better on neuropsychological tests~     than would participants who received the sugar pill.~   "
129405|NCT01361620|"~     The study seeks to identify genomic markers associated with aspirin resistance.~   "
129406|NCT01361607|"~     This 9-week study aimed to determine the efficacy, safety and tolerability of Sativex®~     (Nabiximols) as an adjunctive treatment, compared with placebo in relieving uncontrolled~     persistent chronic pain in patients with advanced cancer.~      Eligible patients were not required to stop any of their current treatments or medications.~   "
129448|NCT01361061|"~     Hepatocellular carcinoma (HCC) is one of the tumors with a rising incidence worldwide. The~     aim of this trial is to improve the detection of early HCC nodules in the liver. At the~     moment screening for HCC in patients with liver cirrhosis is performed by ultrasound and~     measurement of alpha- fetoprotein (AFP). In this trail the tumor markers AFP- L3 (a~     subfraction of AFP) and Des-y- carboxyprothromib (DCP) are measured in addition in order to~     receive information about the course of these markers before the detection of a HCC nodule.~   "
129449|NCT01361048|"~     The investigators are trying a combination vaginal product of higher dose metronidazole~     combined with miconazole to see if it is effective in treating vaginal trichomonas.~   "
129407|NCT01361594|"~     High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are~     associated with increased risk of hospital complications. Blood sugar control with~     intravenous insulin may prevent such hospital complications. Many patients undergoing~     cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly~     before or after surgery). It is not clear what the best insulin regimen is or what is the~     best blood sugar target in these patients. Accordingly, this research study aims to~     determine optimal blood glucose levels during the in patients undergoing cardiac bypass~     surgery. Patients will be divided in two groups. The intensive insulin group will be~     maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a~     glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart~     and regular insulin) are approved for use in the treatment of patients with diabetes by the~     FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after~     cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory~     University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.~   "
129408|NCT01361581|"~     Citrate anticoagulation is associated with metabolic side effects which are linked to a~     portion of citrate reaching systemic circulation. Data on significance of systemic gain of~     citrate and its relationship to method configuration are missing. Patient might also receive~     certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution~     is used. The authors test variable methods of indirect estimate of systemic dose of citrate~     which would allow to quantify the metabolic input without mostly unavailable measurements of~     citrate levels.~   "
129409|NCT01361568|"~     The primary purpose of this study is to determine if CR845 is effective in treating the pain~     associated with a laparoscopic hysterectomy.~   "
129410|NCT01361555|"~     The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836~     in patients with depression.~   "
129411|NCT01361542|"~     Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of~     unknown etiology primarily affecting the spine and sacroiliac joints. In addition to~     formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a~     prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites~     coexisting with reduced bone mass & increased fracture risk. Osteoporosis is a common~     complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in~     disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and~     decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is~     effective in active AS resistant to conventional therapy and helps in improving the bone~     density and over all bone health.~   "
129412|NCT01361529|"~     The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for~     FLP Injection with multiple dose in tumor patients.~   "
129413|NCT01361516|"~     The aim of the study is to compare the impact intravenous sedation versus general anesthesia~     on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.~   "
129414|NCT01361503|"~     The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and~     imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20~     children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For~     comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to~     the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be~     administered a detailed assessment battery consisting of cognitive assessments~     (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of~     psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening~     period at Massachusetts General Hospital (approximately 4 hours of assessments) and one~     scanning visit at McLean Hospital (approximately 1.5 hours).~      The investigators hypothesize that youth with ASD versus controls will exhibit increased~     glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho~     concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize~     that compared to neurotypical controls, the structural integrity of white mater tracts will~     be disrupted in ASD.~   "
129415|NCT01361490|"~     Obesity may have implications on the individual's participation in working life through~     different mechanisms such as comorbidity and loss of functional level. The investigators~     also know that when exiting the working force, it is difficult to get back later. As~     rehabilitation back to working life is often not a very focused aim with weight loss~     treatment, this study sets this as a primary aim by involvement in a 4 week stay at a~     rehabilitation clinic followed by 48 weeks work practice programme at one of three different~     companies.~   "
129416|NCT01361477|"~     As general surgical intensive care units of the biggest tertiary referral university of~     Thailand with more than 1,000 admissions/year. Recently, more complicated perioperative care~     surgical patients were accepted with high complications and resource utilization. Good data~     registration was needed to provide information for quality improvement and resource~     allocation. This prospective observational (crosssectional) study was designed to register~     patient > 18 years who will be admitted to these ICUs for 1 years to explore the adequacy of~     these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU~     complications and adverse outcome /ICU readmission within 72 hours after discharging from~     ICU.~   "
129417|NCT01361464|"~     This phase II trial is studying how well tipifarnib works in treating older patients with~     acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
129445|NCT01361100|"~     This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study~     includes 2 steps. The first one aims to validate the algorithm defined at the time when the~     test was developed in patients with different tumour stages. Patients will be enrolled~     before any treatment. They will immediately undergo the test. No follow-up will be realized.~     In total, 100 patients will be included in this first step. The estimated period of~     inclusion is 6 months.~      If the algorithm is validated, the second step of the study will start. The purpose is to~     determine the characteristics of the test. Enrollment will concern smokers and alcohol~     drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive~     tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a~     maximum of one year. In total, 385 patients will be enrolled in this step during an~     estimated period of 18 months.~   "
129418|NCT01361451|"~     There are 24,000 admissions each year to Intensive Care Units (ICU) in the United Kingdom~     due to pneumonia, asthma and a common condition called chronic obstructive pulmonary disease~     (COPD), with rates of death of 10%, 40% and 50%, respectively. These conditions account for~     10% of all ICU admissions. It is therefore important to find out if it would be possible to~     detect deteriorations in patients with breathing problems early, in order to increase~     appropriately their level of care.~      Clinical early warning scores (EWS) are used in many hospitals to detect patients whose~     medical condition is getting worse, and who are likely to need admission to intensive care~     or high dependency care units. EWS are usually calculated from several measurements taken~     from the patient, such as blood pressure, temperature and heart rate. However, they are~     often inaccurate as they need to be calculated manually by nursing staff from a number of~     measurements taken from a variety of different devices. Furthermore, even when accurately~     calculated, it is not clear how helpful EWS are in predicting whether or not patients will~     deteriorate.~      Neural respiratory drive (NRD) is an objective indicator of breathlessness, and can be~     derived from the amount of electrical activity occurring in certain muscles used in~     breathing. The Myotrace system measures this electrical activity, as well as measurements~     such as rate of breathing and heart rate. It then analyses these measurements together to~     help identify patients at risk of deterioration.~      This study will use Myotrace to monitor patients with severe breathing difficulties due to~     an acute worsening of chronic obstructive pulmonary disease, for early identification of~     failure to respond to medical treatment.~      Patients will be recruited at St. Thomas' Hospital.~      This research is funded by the Guy's and St. Thomas' Charity.~   "
129419|NCT01361438|"~     This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18~     years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral~     administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to~     starting Dasatinib and will continue up to day 31. Patients will continue treatment with~     Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal~     from study.~   "
129420|NCT01361425|"~     Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated~     for preventing stroke and placental abruption. However, the benefit of antihypertensive~     medication maintenance remains unclear, mainly due to the potential risk of fetal growth~     restriction.~   "
129421|NCT01361412|"~     The aim of the study is to identify changes in potential biomarkers after peptide~     immunotherapy for that may subsequently be developed as biomarkers that correlate with~     clinical efficacy.~   "
129422|NCT01361399|"~     The purpose of this study is to investigate the analgesic efficacy of a single dose of a~     fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult~     patients with sore throat associated with a common cold in comparison to a single treatment~     with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active~     ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to~     provide relief from sore throat pain by sequential action. A very fast inset of action will~     be achieved by the locally acting Lidocaine and a long duration of action will be achieved~     by the systemically acting Aspirin.~   "
129423|NCT01361386|"~     The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years~     following the index event) AMPs in patients hospitalized for an acute coronary syndrome~     (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on~     quality of life of these AMPs in a 'real-life' setting.~   "
129424|NCT01361373|"~     Background:~      Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non~     progressive injury to the developing central nervous system in children younger than 3~     years, resulting in neurological and musculoskeletal abnormalities. The main~     pathophysiological causes are encephalopathy of prematurity (periventricular leukomalacia)~     hypoxic ischemic encephalopathy. Infections, infracts and migration defects are other less~     common causes of CP. The brain injury leads to functional motor impairment impacting on~     daily activities commonly manifests as a movement disorder: pyramidal, leading to spasticity~     and extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury~     causes a mixed movement disorder. Dystonia is defined as involuntary muscle contractions~     causing twisting and abnormal postures. While the neurological underpinnings of CP remain~     unknown, a link between low dopamine and increased acetylcholine release has recently been~     reported in dystonia. Dopamine is considered the first line of treatment in children with~     dystonia and CP followed by anticholiergic treatment with trihexphenidyl. The recommendation~     of dopaminergic treatment is based on need to rule out dopamine-responsive-dystonia, a rare~     genetic disorder, and on single case study reporting improvement in CP. A double blind study~     support or refute the use of dopamine treatment for dystonic CP was never reported. Working~     hypothesis and~      Aims:~      In children with CP due to a clear underlying pathology, dopamine treatment will not improve~     daily function. Methods: the investigators will perform a double blinded randomized~     controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological~     cause for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2~     weeks with a 2 week washout interval. Participants will be randomized into 2 groups; one~     will receive placebo followed by dopamine and the other vice versa. The primary outcome~     measure, goal-attainment-scale, and secondary outcome functional measures (such as box and~     blocks, 9 hole pegs, pronation/ supination, finger sequencing) will be assessed at the~     beginning and end of each treatment as well as parent questionnaires regarding satisfaction~     and side effects.~      Expected results:~      No functional improvement with dopamine treatment compared to placebo.~      Importance:~      supplying sufficient data to support or refute the use of dopamine treatment for dystonic~     CP.~      Probable implications to Medicine:~      this may lead to a change in medical treatment guidelines for children with CP.~   "
129425|NCT01361360|"~     In the US, every year approximately 30,000 infants are born very prematurely, with birth~     weight less than 1000 grams. These infants usually require ventilators to help them breath~     normally during the first few weeks of life. Although the ventilator is lifesaving, it can~     also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called~     permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury.~     Importantly, there is new research showing that high carbon dioxide may cause brain injury.~     In our proposed research, we will use magnetic resonance imaging methods to evaluate the~     brain in 40 very premature infants at term−equivalent age (Half of them had permissive~     hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has~     adverse effect on brain development.~   "
129426|NCT01361347|"~     The purpose of this study is to study the number of Participants with Adverse Events as a~     Measure of Safety and Tolerability.~   "
129427|NCT01361334|"~     Long term disease-free survival (DFS) of patients with acute myeloid leukemia (AML) is still~     poor. Recently, so-called targeted therapy for cancer has been introduced to the treatment~     of patients with AML. This phase II clinical trial will explore the efficacy, safety, and~     pharmacodynamics of the tyrosine kinase inhibitor pazopanib in patients with relapsed or~     refractory AML or patients with AML who are not eligible for intensive treatment. Biomarker~     studies will be included to study whether the targets are indeed inhibited and whether this~     leads to decreased BM angiogenesis. Toxicity assessments will be included, and the~     antileukemic effectiveness will be studied.~   "
129753|NCT01357057|"~     The goal of this observational study is to develop and validate a predictive score of 1-year~     outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.~      Using our database filled up prospectively, the investigators plan to collect clinical,~     biological and radiological admission characteristics of coiled SAH cases and their 1-year~     Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score~     in a validation cohort (from 2008 to 2009).~   "
129428|NCT01361321|"~     Edentulism refers to a state of full or partial lack of teeth. This situation may interfere~     with essential functions such as mastication, speech and even appearance.~      Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to~     restore edentulus alveolar ridges by providing support and anchorage for removable or fixed~     dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of~     sufficient bone tissue volume to support the dental implant.A situation like this may~     originate from a variety of reasons such as residual bone atrophy, prior alveolar bone~     destruction due to periodontal disease and even a traumatic tooth extraction. In such cases,~     a routine alveolar bone augmentation is done to enable a dental implant installation at this~     site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus~     bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony~     site requiring augmentation. The bone substitute provides a scaffold to alveolar~     regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells~     to migrate to the bony defect area.~      The investigators research is a aimed to preform a follow up after patients who already went~     through a GBR procedure and before inserting a dental implant. Patients answering the~     inclusion but not the exclusion criteria will go through an alveolar computerized tomography~     (C.T) done routinely before inserting dental implants.At the day of Dental implantation -~     residual bone left from the site of implantation (after preparing the site with a trephine~     bur) will be taken to a histological analysis. The results from the C.T and the histological~     examination will be analyzed for bone quantity (volume) and quality and will allow a~     comparison of bone characteristics obtained by using different routinely used bone~     substitutes.~   "
129429|NCT01361308|"~     The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine~     mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with~     menopause.~   "
129430|NCT01361295|"~     Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state,~     which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The~     induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a~     non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter~     has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be~     expected that these procedures induce a lower level of procoagulation.~      Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients~     undergoing cooled-tip catheter ablation of AF. In this study there will be used to different~     catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter~     is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis~     and CE may be increased.~      The goal of this study is to determine the effect of two different ablation catheters on the~     induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF~     undergoing PVI.~      Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will~     show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients~     with AF undergoing PVI with the cooled-tip catheter.~   "
129431|NCT01361282|"~     Many patients with endothelial dysfunction also present with cataracts. It is therefore~     common practice to perform cataract extraction and intraocular lens (IOL) implantation~     during the same operation and immediately prior to Descemet's Stripping Automated~     Endothelial Keratoplasty (DSAEK), in order to minimize trips to the operating room and the~     associated risks of ocular surgery. However, the unique posterior corneal anatomy of the~     DSAEK recipient makes it difficult to predict pre-operatively the proper power of IOL to~     place, and some patients end up with a mismatched lens that requires spectacle correction.~     The current gold standard for IOL power calculation (A-Scan optical biometry) takes~     measurements of the anterior surface of the cornea and makes assumptions about the posterior~     surface that are violated by the unique hourglass shape of the donor DSAEK graft. New~     optical coherence tomography (OCT) technology provides us with the ability to measure~     curvature in both the anterior and posterior aspects of the cornea in order to generate an~     IOL calculation that has the potential to give more accurate results for our DSAEK patients.~      The investigators will be using the Optovue to perform corneal power analysis on patients~     who have already received DSAEK and cataract surgery, in order to compare the post-op~     Optovue power calculations to the pre-operative power calculations provided by the A-Scan.~     If the OCT is shown to provide accurate IOL power calculations, then some patients might be~     better served by a two-stage procedure where DSAEK is performed and then followed six months~     later by cataract surgery using the OCT to calculate IOL power.~   "
129432|NCT01361269|"~     Few efficient drugs for malaria treatment are available so far. Due to increased exposure of~     these drugs and due to the high risk of development of drug resistant strains of Plasmodium~     falciparum, new drug combinations have to be actively investigated. The investigators will~     test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment~     in acute uncomplicated malaria in children aged 3-10 years.~   "
129433|NCT01361256|"~     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in~     patients with bilateral moderate to profound central vision impairment due to end-stage~     age-related macular degeneration.~   "
129434|NCT01361243|"~     The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+)~     aimed at reducing the problem of overweight and obesity in children.~   "
129435|NCT01361230|"~     The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial~     comparing sedation management using a protocol based on responsiveness with standard~     sedation management. The hypothesis is that responsiveness will improve a range of~     patient-based and economic outcomes, including the duration of mechanical ventilation and~     duration of coma in the ICU. The purpose of the pilot study is to gather information for~     designing a full study that might show the validity of the outcome hypothesis.~   "
129446|NCT01361087|"~     Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular~     differentiation, and other functions in most cells. TGF-β levels play a major role in the~     pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long~     extremities, lens dislocation in the eyes and heart complications such as mitral valve~     prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the~     underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I,~     normally an important component of elastic fibers it has been shown that the Marfan syndrome~     phenotype can be relieved by addition of a TGF-β antagonist in affected mice.~   "
129447|NCT01361074|"~     The aim of this study is to explore the differential efficacy of in vivo exposure versus~     augmented reality exposure in the treatment of specific phobia (small animals).~      The hypothesis is: There will not be significant statistical differences in the efficacy of~     in vivo exposure therapy versus augmented reality exposure in the treatment of specific~     phobia (small animals).~   "
129436|NCT01361217|"~     Inhibitory drug-drug interactions (DDIs) are a considerable concern as inhibition of drug's~     clearance can lead to increased plasma concentrations and subsequent adverse events and~     toxicities. Fluoxetine (Prozac®) is a widely prescribed antidepressant, but is also a potent~     inhibitor of cytochrome P450 (CYP) enzymes. Fluoxetine was chosen as the model inhibitor for~     this study because it is a clinically important inhibitor of multiple CYP enzymes with~     varying potencies for each isoform. From in vitro data, fluoxetine is predicted to be a~     moderate inhibitor of CYP2D6, but a strong inhibitor of CYP2C19 and CYP3A4. However, in vivo~     fluoxetine causes a potent interaction with CYP2D6 and a weak-to-no interaction with CYP3A4.~     The magnitude of the in vivo interaction of fluoxetine with CYP2C19 is not known. This in~     vitro-to-in vivo discrepancy is of concern for two reasons: 1) In clinical drug development,~     in vivo drug-drug interactions are tested only when in vitro experiments predict a risk for~     in vivo DDIs and 2) Because in vivo DDI's are tested using a rank order approach of going~     from the most potent in vitro interaction to the least potent until no interaction in vivo~     is observed. In this study the interaction between fluoxetine and CYP3A4, CYP2C19 and CYP2D6~     will be quantified simultaneously and the quantitative in vitro-to-in vivo predictions~     tested. Fluoxetine will be orally administered daily for 14 days and CYP1A2, CYP3A4, CYP2C19~     and CYP2D6 activity will be tested in the end of fluoxetine dosing using a cocktail of CYP~     probes including caffeine, midazolam, omeprazole and dextromethorphan. Lovastatin will be~     administered on a separate day and used as a second CYP3A4 probe to test whether CYP3A4~     inhibition by fluoxetine depends on the contribution of intestinal CYP3A4 to the probe~     clearance. Plasma and urine samples will be collected for 12 and 24 hrs, respectively,~     during the control sessions (before fluoxetine administration) and for 24 hrs during the~     treatment sessions (fluoxetine multiple dose). The concentrations of each of the probe drugs~     and their metabolites (when applicable) as well as fluoxetine and its metabolites will be~     measured in the collected samples and pharmacokinetic analysis will be performed. The~     primary outcome measures for CYP inhibition will be the increase in the area under plasma~     concentrations time curve (AUC) of each of the probes.The null hypothesis of this study is~     that the area under plasma concentrations time curves (AUCs) of caffeine, dextromethorphan,~     omeprazole, midazolam or lovastatin are the same between the control session and the~     fluoxetine session. Because lovastatin has the greatest variability in its baseline~     pharmacokinetics the study was powered based on the specific null hypothesis for lovastatin.~     The alternative hypothesis is that fluoxetine decreases the clearance of the probe drugs~     resulting in a significant increase in the AUCs between the control and study sessions.~   "
129437|NCT01361204|"~     Long-term practices in a hospital setting and community pharmacy might induce chronic stress~     in students. Alterations of salivary amylase activity will be measured in students during~     pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on~     experimental animals under chronic stress and on humans under short-term stress. The purpose~     of this study is to measure stress symptoms in students during long-term pharmacy practices~     and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the~     salivary amylase activity.~   "
129438|NCT01361191|"~     The aim of the study is to evaluate the event free survival at three years in patients with~     diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction~     therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage~     treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET~     after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP~     without transplant.~   "
129439|NCT01361178|"~     Immunosuppressive therapies have led to remarkable improvements in survival in lung~     transplantation (LT) patients. However, one important adverse effect of these therapies has~     been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen~     mostly in patients with primary immunodeficiency (PID).~      The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500~     mg/dl which might provide better protection against infections than do lower IgG serum~     concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels~     of IgG that are optimal are not yet clearly established. The impact of high versus low IgG~     dosing on the frequency and severity of infections and rejection has not been studied before~     in LT patients with HGG. The specific aims for this study are to compare the incidence of~     infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to~     compare the incidence of infections in lung transplant recipients with mild~     hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of~     all lung transplant recipients, age 18 years or older, at the University of Pittsburgh~     Medical Center (UPMC), with a randomized treatment arm and an observational arm.~      The hypotheses for the research study are:~        -  Therapy with IV or SQ IgG is of substantial benefit in reducing the number of~          infections in lung transplant recipients with severe hypogammaglobulinemia (IgG < 500)~        -  A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher~          impact on the frequency and severity of infections and rejection episodes, compared to~          a lower dose of SQ IgG, with subsequent lower IgG trough levels~        -  Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a~          higher incidence of infections compared to patients with normal IgG levels~   "
129440|NCT01361165|"~     We plan to analyze the data to meet the primary objective of the study:~      To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA,~     during and following treatment with tenofovir DF-containing antiretroviral therapy in~     HIV-infected children.~      In addition, we plan to analyze the data to meet 2 secondary objectives of the study:~        1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid~          hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked~          N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific~          alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir~          DF-containing antiretroviral therapy.~        2. To study immunologic, virologic and clinical effects of tenofovir DF administered to~          HIV-infected children in combination with other antiretroviral therapies.~   "
129441|NCT01361152|"~     The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of~     prospective total knee arthroplasties performed in patients younger than fifty years of age~     with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients,~     to compare~        1. functional scores~        2. rates of radiographic failure~        3. revision rates~        4. survivorship~   "
129442|NCT01361139|"~     This is a study that seeks to characterize data obtained from patients with a variety of~     lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound~     instrument in the doppler mode (not the imaging mode used in examination of pregnant women~     for instance) is placed on the chest wall and the unique software the investigators have~     developed analyzes the signal reflected back from within the lung. On the basis of pilot~     studies performed previously the investigators expect to receive different signals from~     different diseases. The investigators seek to further characterize these signals to enable~     accurate diagnosis of different lung diseases using our technology.~   "
129443|NCT01361126|"~     This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX~     Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in~     subjects who have previously received factor replacement therapy for hemophilia B. The study~     consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5~     month treatment period. Subjects will receive weekly routine prophylactic therapy and~     on-demand treatment for bleeding episodes. In addition, subjects who are not on routine~     factor replacement therapy prior to the study will receive only on-demand treatment for~     bleeding episodes.~   "
129444|NCT01361113|"~     This study will be a single arm phase II clinical trial of 8 weeks of daily, oral~     neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically~     confirmed localized renal cell carcinoma (RCC).~   "
129754|NCT01357044|"~     this is a prospective randomized placebo-controlled double-blinded trial investigating the~     effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality.~     The investigators hypothesize that these plant extracts will improve semen quality.~   "
129450|NCT01361035|"~     What's the purpose of this study? This 4-year study is designed: (1) to teach primary care~     physicians how to recognize low health literacy patients and effectively counsel them on~     cancer screening using risk communication and shared decision making and (2) to assess the~     impact of training on changes in physician communication behavior and changes in low health~     literacy patients' cancer screening behaviors. This study proposal is based on the~     hypothesis that physician training in cancer screening guidelines, health literacy, and~     communication skills will improve provider-patient interactions during encounters dealing~     with preventive health maintenance especially cancer screening.~      How will the proposed study be implemented? Thirty-two physicians in the New Orleans~     metropolitan area will be recruited and randomly assigned to one of two groups. The unit of~     randomization will be the health care organization or clinic. The intervention group will~     receive training in health literacy, cancer screening, risk communication and shared~     decision-making. The control group will not receive communication training until the end of~     the study. Physicians in both groups will undergo three clinic visits with standardized~     patients (actors trained to portray real patients; mystery shoppers) but they will not be~     aware that they are conducting visits with actors. The visits will occur at study enrollment~     and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate~     the physicians' communication skills. Each physician assigned to the intervention group will~     receive verbal feedback on communication skills from the standardized patients and complete~     a web-based tutorial. Physicians in the control group will not have access to the web-based~     tutorial until the end of the study.~      For each physician, 10-15 patients with limited health literacy will be recruited to the~     study. Each patient will rate his/her perceived involvement with care and global~     satisfaction with care at study enrollment and annually for three years. Age and~     gender-appropriate referral rates for breast, cervical and colorectal cancer screening and~     patients' receipt of such screening will be assessed annually for three years. All study~     physicians, regardless of group assignment, will receive performance feedback (report cards)~     on their cancer screening rates among low health literacy patients in their clinic.~   "
129451|NCT01361022|"~     The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm~     Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration~   "
129452|NCT01361009|"~     This is an open-label, multicenter, non-interventional, prospective observational study. we~     collect the safety information of pramipexole over 12w treatment. Parkinson disease patients~     with different severity who have already used pramipexole could be observed in this study.~     In the whole observation period, treatment decision was determined by physician and patient~     completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient~     withdraw, laboratory test.~   "
129453|NCT01360996|"~     The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder~     characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal~     gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS~     effectively reduces circulating androgens. Although OCs are the most common and one of the~     oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular~     menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of~     PCOS women with different body mass index (BMI) are limited. This study is being done to~     compare the hormone and metabolic changes after treatment with low-dose oral birth control~     regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS~     with different body weights.~   "
129454|NCT01360970|"~     Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability~     to induce protective immunity in immunosuppressed travellers are scarce. The investigators~     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis~     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).~   "
129455|NCT01360957|"~     The purpose of this clinical trial is to study the therapeutic effect of black cumin water~     extract (Nigella sativa L.) on obesity and overweight~   "
129456|NCT01360944|"~     The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a~     Psoriasis Plaque Test (PPT).~   "
129457|NCT01360931|"~     Lung cancer is the leading cause of cancer death in Hong Kong. Lung adenocarcinomas is the~     most common type, accounting for 70% of lung cancer and the molecular target of epidermal~     growth factor receptor (EGFR) gene mutation at exons 18 - 21 is present in about 50% of lung~     adenocarcinomas. The v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations~     are commonly present in the other 50% that are EGFR wildtype. EGFR and K-ras mutations are~     found to be mutually exclusive in the same tumor. EGFR-tyrosine kinase inhibitor (TKI) can~     be used as treatment for EGFR mutated tumors while no specific targeted therapy can be~     recommended for EGFR wildtype tumors and these patients often receive chemoirradiation,~     which is toxic and clinical response is suboptimal. There is a need to find alternative~     molecular pathways/targets in EGFR wildtype lung adenocarcinomas.~      Even with EGFR mutations, good clinical response to EGFR-TKI is achieved in about 70% of~     these patients. This would mean suboptimal targeting of the EGFR gene or the presence of~     alternative pathways mediating tumor progression and susceptibility to therapy. Exploration~     of molecular pathways in lung cancer may allow for discovery of new molecular targets for~     therapeutic development.~      Neutrophil infiltration is frequently observed in lung cancer. Recognized similarities~     between neutrophils and cancer cells include (i) ability to circulate as single cells; (ii)~     target attachment via vascular system; (iii) target invasion. The major difference is that~     migrated neutrophils will undergo apoptosis while cancer cells can escape apoptosis.~      This led to the postulation that neutrophils and cancer cells may share similar inflammatory~     cascades by secreting a similar panel of proteases, and one of these could be neutrophil~     elastase (NE). Animal studies demonstrated that NE from neutrophils moves into lung tumor~     cells and mediates lung tumor growth via degradation of Insulin receptor substrate-1~     (IRS-1), leading to activation of intracellular phosphoinositide-3-kinase (PI3k) and the~     v-akt murine thymoma viral oncogene homolog 1 (Akt) signaling pathways and the intracellular~     tyrosine kinase of the platelet-derived growth factor receptor (PDGFR).~      The aims of this study are to demonstrate NE activities and the subsequent signaling~     cascades activated in lung cancer cells, and to verify NE and its related pathway activation~     in clinical lung cancer specimen.~      This study will conclude the roles of NE and the therapeutic potential of~     NE/IRS-1/PI3K/PDGFR pathways in EGFR wildtype lung adenocarinomas.~   "
129458|NCT01360918|"~     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a~     superior alternative to antiarrhythmic drug therapy in patients with symptomatical~     paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing~     elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if~     epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass~     surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the~     effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac~     surgery.~   "
129459|NCT01360905|"~     The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA~     approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and~     pre term labor.~   "
129460|NCT01360892|"~     This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements~     will predict prospectively the incidence of hepatocellular carcinoma, the incidence and~     severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C~     patients.~   "
129461|NCT01360879|"~     This is a multi-center cross-sectional study in which the Real-time Tissue Elastography®~     measurements will be collected prospectively from patients with chronic hepatitis B or C~     virus presenting for liver biopsy.~   "
129462|NCT01360866|"~     To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in~     addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major~     Depressive Disorder (MDD)~   "
129755|NCT01357031|"~     The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to~     placebo and amitriptyline 25 mg in the preventive treatment of migraine.~   "
129463|NCT01360853|"~     The question being asked in this study is: Will patients with advanced pancreatic cancer~     live significantly longer if they are treated with a combination of Gemcitabine and ON~     01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study.~     In the first part of the study, patients with metastatic pancreatic cancer who have received~     no prior chemotherapy for this disease will be assigned by chance either to the group that~     will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this~     group) or, to the group that will be treated with Gemcitabine only (about 50 patients will~     be in this group). How long patients survive in the 2 groups will be compared. If it looks~     like there is no difference between the groups, the study will stop. If it looks like~     patients in the group that were treated with both Gemcitabine and ON 01910.Na survive~     longer, the study will continue into a second part where more patients will be treated in~     order to confirm and better understand the findings of the first part of the study.~   "
129464|NCT01360840|"~     The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD~     525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression~     free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic~     castrate-resistant prostate cancer (mCRPC).~   "
129465|NCT01360827|"~     The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a~     novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin~     and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell~     carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the~     dose levels.~   "
129466|NCT01360814|"~     This randomized clinical trial studies structured multidisciplinary intervention or standard~     medical care in improving quality of life (QOL) in patients receiving active cancer~     treatment. A structured multidisciplinary intervention may improve the QOL in patients~     receiving treatment for cancer. It is not yet known whether structured multidisciplinary~     intervention is more effective than standard medical care in improving QOL~   "
129467|NCT01360801|"~     The investigators seek to test the hypothesis that the improved version of high definition~     white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual~     Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments~     than current versions of these endoscopes.~   "
129468|NCT01360788|"~     Recently integrated in clinical practice, the Global Initiative for Chronic Obstructive Lung~     Disease (GOLD) classification states that a mild (stage I) chronic obstructive pulmonary~     disease (COPD) is present, in a smoker, when the postbronchodilator forced expired volume in~     1 second (FEV1) to forced vital capacity (FVC) ratio is < 0.7. A major change that was~     introduced by the GOLD classification system was that COPD could be diagnosed despite an~     FEV1 that is within normal predicted values (above 80% predicted). Because it suggests~     diagnosing and detecting COPD earlier than done until very recently in medical practice, the~     GOLD standards bring in a new reality to clinicians. In fact, this novel COPD classification~     comes with new research challenges because the functional impacts and systemic consequences~     related to COPD are mostly documented in patients with moderate to severe stages with little~     information specifically in GOLD stage I COPD. This information is important if the~     investigators are to convince physicians that GOLD stage I COPD needs to be diagnosed and~     eventually treated.~      The investigators aimed to characterize GOLD stage I COPD patients according to~     activity-related dyspnea. More specifically, our objectives were to compare:~      i) baseline pulmonary function ii) exercise capacity iii) quadriceps muscle function iv)~     levels of physical activity in daily life~      between symptomatic (Sx) GOLD stage I COPD patients, asymptomatic (ASx) GOLD stage I COPD~     patients and healthy control subjects (CTRL). The investigators reasoned that exercise~     tolerance and physical activity levels would be decreased in Sx GOLD stage I COPD patients~     as it would be similar between ASx GOLD stage I COPD patients and CTRL.~   "
129469|NCT01360775|"~     Objective: To assess the effect of a nutritional educational intervention on the risk of~     malnutrition dependent patients aimed at the caregivers.~      Material and methods:~      Intervention study with control group, with 200 patients randomized selected, in a Home Care~     Program of 5 Primary Care Centers, malnourished and dependents, older than 65 years and with~     a caregiver.~      Socioeconomic and cultural characteristics of the patient and the caregiver are collected.~     Mini Nutritional Assessment (MNA), food intake, anthropometric and serum parameters of~     nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron,~     ferritin, are evaluates on 0- 6-12 months. Also evaluated dentures, basic activities of~     daily living (Barthel test), cognitive state (Pfeiffer test) status of mood (Yesavage test).~      Prior to the intervention, the educational procedure and the design of educational material~     are standardized among nurses. The nurses make an initial session for caregivers and~     monitored the education at home monthly (4 visits) up to 6 months. NANDA (NORTH AMERICAN~     NURSING DIAGNOSIS ASSOCIATION) specific methodology of the Nursing profession is used. The~     investigators studied the effect of the intervention on the caregivers on the patient's~     nutritional status by the MNA test, diet, anthropometry and biochemical parameters.~      Bivariate normal test statistics and multivariate models were created to adjust the effect~     of the intervention.~      The program SPSS / PC was used.~   "
129476|NCT01360684|"~     Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7~     couples. Measuring basal body temperature is a technique that has been used since the 1930's~     to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT~     charts to predict ovulation, as it has not been established to reliably confirm ovulation.~      The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure~     of axilla temperature whilst worn under the arm.~      The investigators plan to compare the temperature measurements of the DuoFertility sensor~     with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's~     menstrual cycles, up to 10 cycles per women.~      The investigators aim to investigate if continuous axillary skin temperature measurement~     obtained from the DuoFertility sensor, provides comparable results for identifying the~     occurrence of ovulation as the gold standard transvaginal ultrasound scan.~   "
129477|NCT01360671|"~     To determine the efficacy of iv sildenafil in term and near term infants with PPHN~     (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric~     oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control~     group not treated with sildenafil.~   "
129470|NCT01360762|"~     Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being~     associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment~     (ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian~     VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via~     a combination of effective treatment of the initial episode, timely ART and prevention of~     relapses.~      Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses,~     which can result in death, severe illness, reduced ART efficacy, drug-resistance and~     possibly transmission of drug-resistant Leishmania donovani. Patients most vulnerable to~     relapses are those with high levels of immunosuppression, with previous VL episodes, or with~     opportunistic infections (OIs). The most important factor to prevent relapses seems to be~     the clearance of visible parasites.~      Limited studies in Europe show that HIV co-infected patients may benefit from secondary~     prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine~     (PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied~     in African VL, but the poor outcomes without secondary prevention highlight a need of better~     care to patients at risk of relapse.~      This prospective cohort study aims at documenting the patient's outcomes of secondary~     prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and~     feasibility, before it can be considered for general use in Ethiopia. A placebo group is not~     included, due to the clear advantages of the intervention to the patient population.~   "
129471|NCT01360749|"~     Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina~     (lidocaine cream) in reducing pain associated with laser hair removal in women.~   "
129472|NCT01360736|"~     The investigators propose to test the efficacy of a brief, readily accessible, and~     personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown,~     2012).~   "
129473|NCT01360723|"~     The investigators previously pointed out the significant association between urinary arsenic~     profiles and urothelial carcinoma (UC) risk through a 12-year follow-up study. Further, the~     investigators observed the increased UC risk in people with lower plasma folate and higher~     homocysteine than those with higher plasma folate and lower homocysteine in 2010.~     S-adenosylmethionine (SAM) is one factor included in one-carbon metabolism pathway and is~     the main donor of methyl group in cells. The ratio of SAM and its metabolite~     S-adenosylhomocysteine (SAH) not only reflected the intake level of dietary folate but also~     demonstrated the extent of global DNA methylation. These factors might play important roles~     in UC carcinogenesis. The investigators would expect to take three years to explore the~     interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary~     arsenic profiles, the polymorphisms and haplotype of Glycine N-methyltransferase (GNMT) and~     UC. In the first year, the investigators would measure the levels of plasma folate,~     homocysteine, SAM and SAH and evaluate the associations between these factors and UC risk.~     In the second year, the investigators would set up the method of immunohistochemistry stain~     and compare the differences between the global DNA methylation from bladder tissues and~     blood. In the last year, this investigators would analyze the GNMT gene polymorphism and~     haplotype variation. At the same time, the investigators would explore the impact of GNMT~     genetic variation and global DNA methylation on UC risk. Based on the results from our~     research, the investigators might propose that the decreased ratio of SAM/SAH resulted in UC~     risk increased. This mechanism might be through the changed levels of urinary arsenic~     profiles and global DNA methylation.~   "
129474|NCT01360710|"~     Obesity is a major risk factor for the development of hypertension. Based on population~     studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension~     can be directly attributed to obesity. Obesity per se is commonly associated with activation~     of the sympathetic nervous system with a predominant increase in sympathetic outflow to the~     kidneys and the peripheral vasculature and there is now conclusive evidence that heightened~     sympathetic nerve activity is a major contributor to the elevation in blood pressure~     associated with obesity, particularly in young subjects. In line with these findings,~     dietary weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve~     activity and lower blood pressure levels.~      Several lines of evidence have well documented the significant role of SNS activation in~     obesity associated hypertension and target organ damage. Weight loss is the preferred~     treatment option for obesity and its consequences and reduces both SNS activation and blood~     pressure. In the real world however, weight loss maintenance is rarely achieved in obese~     patients highlighting the urgent need for alternative treatment strategies. Given the~     crucial involvement of SNS activation in various aspects of the obesity related increase in~     blood pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory~     agents at an early stage is an obvious choice.~      The investigators therefore plan to examine the effects of the centrally sympatholytic agent~     moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity,~     regression of early target organ damage (heart, kidney and endothelium), metabolic and~     inflammatory markers in young obese subjects with hypertension in a randomized, double-blind~     clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to~     achieve similar blood pressure reductions in both groups. The investigators hypothesize that~     moxonidine treatment will result in significant improvements in these outcome parameters and~     beneficial effects beyond simple blood pressure reduction.~      Findings from this study could pave the way for an early and pathophysiology- tailored~     treatment strategy of obesity related hypertension and its detrimental consequences.~   "
129475|NCT01360697|"~     In this demonstration project (JADE in Jiangsu & Anhui Program, JADE-JA in short) led by key~     opinion leaders in the field of diabetes and endocrinology in Jiangsu and Anhui area and~     supported by the ADF, shall recruit 4800 type 2 diabetic patients attending medical~     out-patient clinics in the area to compare the effects of usual versus structured care~     (non-JADE vs JADE) on metabolic control, quality of life and behavioral changes. After~     explanation by trained doctors and nurses and with written informed consent, patients will~     be randomized to either the JADE or non-JADE group. The former encompasses all components of~     the structured care delivered by a trio-team of doctor, nurse and Healthcare Assistant (HCA)~     while the non-JADE group only consists of comprehensive assessments (CA) at baseline and~     12-month with patients managed in the usual manner thereafter. At the end of 12 months, all~     patients will undergo repeat comprehensive assessments for comparison of rates of attainment~     of treatment targets, behavioral changes, quality of life and default rates. The~     acceptability of the JADE-JA Program by patients and the trio-team will also be evaluated.~      The investigators hypothesize that the use of state of the art information technology to~     record, manage and analyze the large amount of clinical information generated during various~     consultation visits will improve the effectiveness and efficiency in implementing these care~     protocols through decision support and regular feedback to both patients and care team.~   "
129774|NCT01356784|"~     TEst the effect of Tailored Physical Activity or Chronic Pain Self-management Program on~     Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper~     Body~   "
131493|NCT01334112|"~     The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the~     treatment of unresectable/metastatic hepatocellular carcinoma (HCC)~   "
129478|NCT01360658|"~     Solar urticaria is a rare but debilitating disease that can severely impact the quality of~     life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic~     drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization~     or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic~     urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7~     patients, to dramatically improve 71% of patients. In an open-label prospective multicenter~     study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10~     patients affected with severe and refractory solar urticaria.~   "
129479|NCT01360645|"~     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive~     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in~     patients with Major Depressive Disorder who demonstrate an incomplete response to a~     prospective trial of the same assigned FDA approved ADT~   "
129480|NCT01360632|"~     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive~     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in~     patients with Major Depressive Disorder who demonstrate an incomplete response to a~     prospective trial of the same assigned FDA approved ADT~   "
129481|NCT01360619|"~     The researchers believe that the multifunction Keito devices shares with TANITA TBF-300~     (K014009) the same efficacy on the body fat measurement. Even if the body contact points are~     not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate~     gives results as similar as the multifunction keito does.~   "
129482|NCT01360606|"~     This is a phase I dose escalation study. Dose escalation will be via the traditional up and~     down scheme. SBRT:~      Patients will receive one of the following radiation regimens:~        -  50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.~        -  60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.~        -  75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.~   "
129483|NCT01360593|"~     The current study seeks to further investigate the impact of up-front systemic therapy in~     combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic~     adenocarcinoma.~   "
129484|NCT01360580|"~     Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged~     invasive ventilation (more than seven days), using a clinical statement. All consecutive~     patients are screened, and clinical evaluation is performed during 48h after patient's~     extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be~     created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data~     complementary are notified at day 28 (pneumonia? nutritional status?)~   "
129485|NCT01360567|"~     The aim of the study is to examine whether the extract of green tea is effective on type 2~     diabetes and hyperlipidemia.~   "
129486|NCT01360554|"~     This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the~     efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients~     with advanced non-small cell lung cancer, previously treated with at least one prior~     regimen. Analyses of primary objective (Progression Free Survival) will be done in two~     co-primary populations as defined in the protocol.~   "
129487|NCT01360541|"~     Radiofrequency ablation versus endoscopic surveillance in the management of low grade~     dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.~   "
129488|NCT01360528|"~     Therefore preterm infants must need folic acid replacement than term babies.~   "
129489|NCT01360515|"~     This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety~     and tolerance.~   "
129490|NCT01360502|"~     This is a prospective study designed to assess safety and potential influence of the MiroCam~     on cardiac pacemaker and implantable cardiac defibrillator.~   "
129491|NCT01360476|"~     This project seeks to reduce the disparity in hypertensive heart disease which exists for~     African-Americans who have poorly controlled hypertension (HTN), also known as blood~     pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject~     population which stands to benefit tremendously from better BP control and a corresponding~     decrease in heart damage. HTN occurs early in life and more often in African-Americans,~     reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize~     the emergency department (ED) for chronic BP management. Like cardiovascular disease,~     vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to~     play an important role in cardiovascular health. Vitamin D replacement in those who are~     deficient has been thought to reduce the cardiovascular disease, especially if initiated~     early before irreversible damage has occurred, but this has yet to be tested in a~     prospective clinical trial. Accordingly, this proposal was designed to investigate the~     relationship between vitamin D and cardiac damage (as identified on cardiac magnetic~     resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive~     patients without prior history of heart disease.~      The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in~     vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment,~     which, if shown to be effective could improve the existing approach to a widely accessible,~     cost-effective option.~   "
129502|NCT01360333|"~     When subjected to fluid loss or fluid deficiency irrespective of disease or environmental~     factors it is discussed how to rehydrate or how to hydrate prophylactic.~      In medical care it is common to give infusions. However it has increasingly become common to~     hydrate the patient through the mouth even early after bowel surgery. Moreover it is more~     simple to provide energy the natural way.~      Which fluid to give, depends on several factors such as possibility to drink, the volume and~     emptying of the stomach as well as the fluid absorption in the bowel.~      The provided fluid can also influence this process depending on temperature,~     osmolality/tonicity and composition (carbohydrates or salts).~      In this study we wish to study the speed with which the provided fluid is absorbed by the~     bowels and how fast the fluid is distributed to the different body compartments depending on~     it's composition.~      The three fluids will be either tap water, high sodium chloride and a carbohydrate rich~     fluid.~   "
129503|NCT01360320|"~     This is a randomized, placebo controlled, multicentric trial to investigate the effect of~     diet supplementation with green tea extract containing 300mg epigallocatechin gallate~     (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.~   "
129492|NCT01360463|"~     According to UNAIDS, Indonesia is experiencing one of the most rapidly expanding HIV/AIDS~     epidemics in Asia. The epidemic in Indonesia has been fueled by injection drug use among~     heroin users and the national response includes the scale-up of methadone maintenance~     treatment.~      Drug counseling is considered to be an integral part of methadone treatment, but few studies~     have been designed to assess its benefits and costs. In settings such as Jakarta, data~     regarding the costs and benefits of drug counseling have critical public heath relevance.~      The investigators propose to conduct a prospective randomized trial to evaluate the efficacy~     of integrated drug and HIV counseling among injecting drug users. This study will be~     conducted at six methadone clinics in Jakarta, Indonesia where the HIV prevalence among~     injecting drug users ranges between 50- 86%, with collaborators from the Drug Dependence~     Hospital in Jakarta, the University of Pennsylvania and Yale University. The specific aims~     of this four year study are to evaluate the impact of Behavioral Drug and Risk Counseling~     (BDRC)—a low intensity, cognitive behavioral approach that integrates drug counseling and~     risk reduction intervention. Those assigned to the BDRC arm will be compared to those who~     receive treatment as usual which includes an initial risk reduction intervention and~     counseling as needed. The investigators hypothesize that the structured, low intensity BDRC~     approach will be more cost effective and result in higher rates of retention in treatment,~     lower rates of drug use and lower rates of HIV risk.~      To test these hypotheses, the research team in Jakarta will recruit 300 injecting drug users~     as they enter treatment at the Drug Dependence Hospital and its five satellite programs.~     Following informed consent procedures, research staff will randomize participants to either~     the BDRC intervention or to treatment as usual. All subjects will be fuly assessed at~     baseline and months 3, 6, 9, and 12.~      The proposed work will be build on collaborations that have been established with the~     Indonesian Investigator Adhi Nurhidayat,MD during his NIDA INVEST Fellowship at University~     of Pennsylvania when he spent time with David Metzger, PhD and George Woody, MD. It will~     also extend findings from a WHO study on substitution therapy of opiates and HIV/AIDS that~     was completed by Riza Sarasvita, MS,MHS (former NIDA Humphrey Fellow at Johns Hopkins~     University) and her colleagues at The Drug Dependence Hospital Jakarta, Indonesia.~   "
129493|NCT01360450|"~     Thousands of critically ill infants (and children) are exposed to opioids and~     benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and~     pediatric intensive care units. While the use of these agents are undisputedly beneficial in~     reducing pain and anxiety, improving ventilation, reducing pulmonary vascular resistance and~     improving outcomes; the consequence is often the development of tolerance and physiologic~     dependence - similar to prenatal exposure from these same classes of drugs. The~     investigators have recently reported the results of randomized placebo control trial showing~     that the addition of clonidine (central alpha 2 agonist) to tapering doses of opioids was~     efficacious and safe in treating opioid dependence in infants who had moderate to severe~     neonatal abstinence syndrome from prenatal drug exposure to opioids. Currently, the~     investigators propose to perform a double-blind, randomized placebo control trial in a~     cohort of critically ill infants without prenatal drug exposure at Johns Hopkins Hospital to~     test the overall hypothesis that early addition of clonidine to a cohort of critically ill~     neonates on mechanical ventilation who are receiving opioids and benzodiazepines for~     analgesia and sedation will be efficacious and safe in reducing both the incidence and~     severity of withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete~     sedative and analgesic drug detoxification. The hypothesis will be tested by addressing 2~     specific aims that will determine: 1) the efficacy and safety of clonidine in critically ill~     infants, and 2) pharmacokinetics and pharmacodynamics using population-based~     pharmacokinetics in this vulnerable infant population who have only been exposed to these~     drugs as part of their routine care. Many standard of care practices are incorporated in~     neonatal and pediatric care prior to evidence based studies. This proposal will fill a much~     needed gap in translating what the investigators have learned about basic mechanisms~     mediating dependence and withdrawal to proven therapies for vulnerable pediatric~     populations.~   "
129494|NCT01360437|"~     This is a single-center, randomized, single-blind, investigator-initiated pharmacological~     study with a crossover design. Patients with acute coronary syndrome (ST-elevation~     myocardial infarction, non-ST elevation myocardial infarction, unstable angina) and~     presenting high on-clopidogrel platelet reactivity as assessed with the VerifyNow assay~     (platelet reactivity units PRU≥235) 24 hours post percutaneous coronary intervention (PCI),~     will be randomized after informed consent in a 1:1 ratio to either prasugrel 10mg/d or~     ticagrelor 90mg twice a day for 15 days. Platelet reactivity assessment will be performed at~     Day 15±2 days and then a crossover directly to the alternate treatment group for an~     additional 15 days period, without an intervening washout period will be carried out.~     Patients will return at Day 30±2 days for platelet reactivity assessment.~   "
129495|NCT01360424|"~     The purpose of this study is to analyse efficacy of teriparatide treatment in patients with~     new forms of inherited low-turnover osteoporosis.~   "
129496|NCT01360411|"~     In this single centre study we study the use of endoscopic ultrasonography (EUS) combined~     with elastography in order to separate malignant tissue from benign tissue in and adjacent~     to the upper gastrointestinal tract.~   "
129497|NCT01360398|"~     The aim of this study is to generate epidemiological data to further explore determinants of~     Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral~     pathogens to Acute Exacerbation of COPD (AECOPD) episodes.~   "
129498|NCT01360385|"~     Recent studies have shown a remarkably positive effect of 6 monthly injections of~     Ranibizumab on eyes with CRVO. The disease may cause severe sight threatening complications,~     partly due to restrictions in blood flow and oxygenation . Although Ranibizumab has been~     shown affective to reduce oedema of the retina, it is not known whether the drug ameliorates~     or aggravates restrictions in oxygenation.~      The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal~     vessels and thus the state of retinal oxygenation.~      The primary objective of the study is to evaluate the effects of injections of Ranibizumab~     on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion~     (CRVO),~      The secondary objective is to evaluate the effects of injections of Ranibizumab on visual~     acuity and retinal oedema in eyes with different degree of ischemia.~   "
129499|NCT01360372|"~     It is hypothesized that using methylnaltrexone in addition to pain killer narcotics~     (opiates) in patients will result in increased tube feeding rates with more frequent~     nutrition at goal calorie rate.~   "
129500|NCT01360359|"~     The purpose of this randomized clinical trial of low back pain exercise programs is to~     determine if trunk control can be changed by core stabilization exercises. The proposed~     mechanism of pain reduction and functional improvement of core stabilization exercises is~     that it enhances trunk movement and muscle control. This study will provide preliminary~     evidence of the link between patient outcomes and treatment mechanisms.~      The investigators hypothesize that:~        -  both treatment groups will demonstrate significant improvements in pain and function;~        -  only subjects in the core stabilization group will demonstrate significant improvements~          in trunk movement and muscle control.~   "
129501|NCT01360346|"~     Recent studies suggest the employment of 'conscious' sedation (1) for critically high - risk~     patients (2), showing more efficacy then deep sedation (3). The investigators want to~     compare intravenous injection versus enteral sedative drugs administration, purposing to~     maintain a 'conscious' sedation level compatibly with the needed cares, invasive procedures,~     and medical and nursing surveillance.~   "
129504|NCT01360307|"~     The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered~     instrument that not only evaluates depressive symptoms but also both functioning and quality~     of life. The assessment of patients´ perspective may provide valuable information that could~     be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a~     psychometric validation into Spanish of the CUDOS scale in patients with major depression~     disorder in a primary care setting.~   "
129507|NCT01360268|"~     Rationale for this study:~      Correction of hypocholesteremia and insulin resistance after successful eradication of HCV~     by combination therapy of interferon and ribavirin has been shown in several studies. The~     majority of these studies examined genotype 1 and some genotype 3 patients, but it is not~     clear if the same results can be achieved in other genotypes of HCV.~      Moreover, clinical data of the relationships between different adipocytokines, metabolic~     profiles, and HCV and treatment is of value to further understand the mechanisms for~     HCVrelated metabolic alterations. The present proposal is designed to address the paradox of~     HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI~     influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and~     analyzing the samples from humans with HCV infection prior to and after combination of~     peginterferon alpha-2b plus ribavirin~      For metabolic alternations:~      Lipid profile: After treatment, responders in both genotype I and II will experience more~     increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin~     resistance: After treatment, responders with both genotype I and II will experience more~     decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will~     achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this~     study is more of exploratory propose as there is still little well established consensus.~   "
129508|NCT01360255|"~     Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide.~     Often treatment possibilities are limited and only palliative treatment such as a~     transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three~     months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP~     ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last~     years new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin~     (DCP) have been examined. In this clinical trial the course of these markers are examined~     after TACE in order to receive hints if the patient will be a therapeutic responder.~      Furthermore the investigators are interested in the quality of life after TACE. Patients~     receive a questionnaire with regard to the quality of life before and 3 months after TACE.~   "
129509|NCT01360242|"~     In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators~     hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus~     aspiration and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with~     optimal antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as~     assessed by Cardiac Magnetic Resonance Imaging (CMRI).~   "
129510|NCT01360229|"~     This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can~     safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will~     receive either real or sham acupuncture twice weekly for six weeks.~   "
129511|NCT01360216|"~     The purpose of the study is to measure whether an education and training intervention for~     clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will~     result in greater use of the methods among contraceptive patients.~   "
129512|NCT01360203|"~     The purpose of this study is to compare the effect of implementing wireless remote~     monitoring combined with structured telephone monitoring, versus current care, on variation~     in rehospitalization among older patients hospitalized with heart failure at six medical~     centers.~   "
129513|NCT01360190|"~     The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as~     a method for the detection of antidepressant treatment response. The investigators have~     developed a QEEG algorithm called cordance that appears to provide much the same~     information about brain function as PET or SPECT scanning, and has shown patterns of brain~     function that appear to be indicative of depression. Of greatest interest is that these~     patterns appear to normalize in response to antidepressant treatment.~   "
129514|NCT01360177|"~     This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT~     pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS~     [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT~     scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a~     cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid~     irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25~     to 100 mCi.~   "
129515|NCT01360164|"~     The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive~     incoordination of gait and often associated with poor coordination of hands, speech, and eye~     movements. Current treatments for Hereditary Ataxias are mainly pharmacological,~     rehabilitative, or psychological treatments，while no effective treatment available. Stem~     Cell therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment.~     In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells~     transplantation will be evaluated in patients with Hereditary Ataxias.~   "
129516|NCT01360151|"~     This is a prospective, comparative control analysis. The investigators want to evaluate the~     aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal~     vasculopathy and the effect of photodynamic therapy and combination treatment of~     photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth~     factor.~   "
129517|NCT01360138|"~     Ligamentum flavum in the cervical region is thin or not fused at the midline. The~     investigators inferred that the size and elasticity of the ligamentum flavum, in combination~     with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in~     some patients. If so, the investigators hypothesized that the paramedian approach would be~     advantageous for finding cervical epidural space more easily during cervical epidural~     steroid injections (CESIs).~   "
129518|NCT01360125|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study studies biomarkers in samples from patients with newly~     diagnosed acute myeloid leukemia treated with cytarabine-based chemotherapy.~   "
129789|NCT01356589|"~     This retrospective observational study will assess the incidence of hemoglobin cycling in~     chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera~     (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a~     9-month treatment period.~   "
129519|NCT01360112|"~     A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate~     goal of eradication of this disease. Transmission blocking vaccines work by inducing~     antibody in vaccinated individuals that inhibits the development of malaria parasites in the~     mosquito, thus interrupting the cycle of transmission to the next human host. Efficacy of~     these vaccines may be estimated by in vitro membrane feeding assays using immune sera and~     laboratory strain mosquitoes, but these assays need to be qualified to determine to what~     extent they are predictive of transmission blocking in the field. Clinical trials of~     transmission blocking vaccines are also anticipated and have started in this community. This~     protocol will use a nested casecontrol cohort design to compare results of mosquito feeding~     assays in a malaria exposed population in Bancoumana and surrounding villages in Mali.~     Households will be identified using census data and individuals will be consented for~     participation. Malaria smears will be obtained at monthly visits, and gametocytemic~     individuals will be asked to participate in direct feed experiments using insectary-raised~     mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed~     in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and~     parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3~     months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from~     Bancoumana were enrolled and participants older than 5 years of age who were enrolled in~     2011 and wanted to continue participation were re-enrolled into the study. A transmission~     blocking vaccine trial started in May 2013, and has enrolled participants from this adult~     cohort in that study. Up to 50 new adults from Bancoumana and surrounding villages will be~     enrolled in 2014 and those volunteers previously enrolled into the study over theage of 5~     years old will be offered re-enrollment into the study.~   "
129520|NCT01360099|"~     Background:~      - Osteoporosis is a condition where the bone becomes more brittle and more likely to break~     as a person ages. The drugs that people take to treat this condition have prevented many~     common hip fractures. But these drugs may be associated with problems in the shape and~     structure of the hip bone after many years of use. These changes in the hip bone may lead to~     an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them.~     Researchers want to learn more about these fractures.~      Objectives:~      - To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for~     several years, those who have just started taking them, and those who have never taken these~     drugs.~      Eligibility:~        -  People at least 50 years of age who have been taking osteoporosis drugs for at least 5~          years.~        -  People at least 50 years of age who have been taking these drugs for less than 1 year.~        -  People at least 50 years of age who have never taken these drugs.~      Design:~        -  All participants will have three total visits over 3 years.~        -  At the first visit, those taking part will have a medical history and physical exam.~          They will complete a questionnaire about medication use and bone health. They will also~          have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to~          test for osteoporosis) of the hips.~      Those in the study will repeat these exams and medical history questions at followup visits.~     These visits will take place 18 months and 36 months after the first study visit.~        -  At any of these visits, participants who may have a hip fracture that does not show up~          on the x-rays will have an imaging study to examine the bone more closely.~        -  Participants who receive a hip replacement or suffer from a broken bone at any time~          should inform the study researchers as soon as possible.~   "
129521|NCT01360086|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin~     calcium, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving~     more than one drug (combination chemotherapy) together with cetuximab before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~     Giving these drugs after surgery may kill any tumor cells that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin,~     and leucovorin calcium together with cetuximab and to see how well they work in treating~     patients with adenocarcinoma of the stomach or gastroesophageal junction.~   "
129522|NCT01360073|"~     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary~     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as~     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients~     with serious coronary heart disease using two UK primary care databases.~   "
129523|NCT01360060|"~     Magnesium sulphate is the first line therapy for the management of preeclampsia and~     eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved~     to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic~     effect of magnesium in parturients undergoing Cesarean section.~   "
129524|NCT01360047|"~     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary~     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as~     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time~     users of low dose ASA for secondary prevention using a UK primary care database.~   "
129525|NCT01360034|"~     The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin~     as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).~   "
129526|NCT01360021|"~     This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the~     Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.~   "
129527|NCT01360008|"~     Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation~     will be investigated in a cohort study design in experienced electrophysiologic (EP) centers~     analyzing propensity-matched cohorts.~   "
129528|NCT01359995|"~     The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients~     with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan~     University hospital.~   "
129529|NCT01359982|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001~     for injection in subjects with advanced solid tumors or lymphomas for which there are no~     currently accepted curative therapies. This study will also conduct an exploratory~     evaluation of objective tumor response using CT or MRI.~   "
129530|NCT01359969|"~     This open-label study is being conducted to confirm the safety, pharmacokinetic profile and~     efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema~     attacks in patients, from 2 up to and including 13 years of age.~   "
129531|NCT01359956|"~     This study evaluated two chemotherapy regimens with and without the addition of interferon~     in patients with advanced or recurrent melanoma.~   "
129532|NCT01359943|"~     The study compared the efficacy and assessed the safety of secukinumab given as 3~     intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to~     placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis~     (RA) despite treatment with Methotrexate.~   "
129533|NCT01359930|"~     The study is to primarily measure safety and interactions between oral doses of~     Naltrexone/Bupropion and i.v. Methamphetamine.~   "
129534|NCT01359917|"~     The hypotheses of this study were that:~        1. HIV lipodystrophy is associated with psychological morbidity relating to body image,~          anxiety and depression.~        2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or~          Bio-alcamid, is associated with an improvement in psychological morbidity and~          anatomical volume of treated areas.~        3. The DI3D system is a valid and reproducible method of recording and measuring facial~          3-D volume.~   "
129535|NCT01359904|"~     Background:~      Type II diabetes is a disease that affects more than 246 million people worldwide. Most~     importantly, one of the complications of type II diabetes is kidney damage and this has lead~     to many patients seeking hemodialysis treatment, a type of kidney replacement therapy.~     However, during hemodialysis treatment, many patients are greatly at risk for having their~     blood sugar drop below normal and this can lead to neurological problems. Also, it has been~     reported that hemodialysis patients who have poorer control of blood glucose levels are at~     risk to developing heart problems. It has been shown that adding 5.5 mmol/L of glucose in~     the hemodialysis treatment can reduce the chances of having an abnormal decrease in blood~     glucose levels. Currently, some institutions use 10 mmol/L of glucose (instead of 5.5~     mmol/L) in the hemodialysis treatment, however, there is little documented support to~     justify for this action.~      Objective:~      The investigators are would like to explore the effects of use of 10 mmol/L of glucose in~     hemodialysis treatment and to determine if it worsens control of blood glucose levels, both~     during the treatment sessions and over the long term in type II diabetes patients. Also,~     patients on hemodialysis are prone to infection, so we will also observe if there is any~     change in infection rate among these patients with increased glucose in the treatment.~      Methods:~      The study will consist of 40 patients who will be randomly split into 2 groups. One group~     will be treated with 5.5 mmol/L glucose in the hemodialysis treatment and the other group~     will have 10 mmol/L glucose in the treatment. During the hemodialysis treatment, patient~     blood glucose will be measured at set intervals to check for any acute drops in glucose~     levels. Also, to assess long-term control of blood glucose levels, each patient will have 2~     blood tests, one at the start and another at the end of the experiment. Signs of infection~     will be checked at the start of each session. Each patient will remain in their group for~     the duration of the study, which is 12 weeks.~   "
129536|NCT01359891|"~     The protein ST2 is a member of the interleukin-1 receptor family. Blood concentrations of~     the soluble isoform of ST2 (sST2) are increased in inflammatory and heart diseases and are~     considered a prognostic marker in both. The Presage™ST2 assay was recently shown to meet the~     needs of quality specifications of laboratory medicine. Soluble urokinase plasminogen~     activator receptor (suPAR) levels reflect inflammation and elevated suPAR levels are found~     in several infectious diseases and cancer. Both sST2 and suPAR have recently been introduced~     as sensitive biomarkers for patients with septicemia. Both may be promising or even superior~     alternatives to currently established sepsis markers leading to an improvement of outcome in~     patients with septicemia. However, a clinical study which clarifies kinetics of values over~     time/possible correlation with causative pathogen/progress/deterioration of septic patients~     is urgently needed before these biomarkers can be established in clinical routine.~      Primary study objectives To clinically evaluate sST2 and suPAR in patients with bacteremia~     /septicemia. To correlate results with causative bacterial organisms, response to or failure~     of antiinfective treatment, severity of clinical status as well as outcome.~      To study the kinetics of the test results and to correlate the sST2/suPAR results with other~     well established infection markers (e.g. C-reactive protein, procalcitonin, blood counts).~      Natural endpoints of the study will be patient's death or complete recovery.~      This is an explorative study. To meet the objectives both novel biomarkers will be~     clinically evaluated in a cohort of 500 in-patients with septicemia at the University~     Hospital Graz. Starting the day a patient's blood culture turned positive the investigators~     will collect samples every 12h within the first two days and then every 24h.Measurement of~     sST2 and suPAR values will be done retrospectively. To analyze clinical~     sensitivity/specificity of the novel biomarkers sST2 and suPAR as prognostic factors for~     development of bacteremia/septicemia, a second cohort consisting of 250 in-patients will be~     investigated in a longitudinal matter. Patients without a previous positive blood culture~     test during the current episode of disease for which blood cultures are ordered by a~     physician will be included and sST2 and suPAR levels will be determined from samples taken~     simultaneously with this first blood cultures.~   "
129537|NCT01359878|"~     Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths~     worldwide each year. The investigators aim to investigate if early treatment with fibrinogen~     concentrate versus saline can reduce the incidence of blood transfusion in women with~     postpartum haemorrhage.~      A low level of fibrinogen has been associated with increased blood loss and transfusion~     requirements in different clinical settings including obstetrical bleeding. Early up-front~     treatment with fibrinogen may reduce incidence of transfusion by securing optimal~     haemostatic capacity in women with postpartum haemorrhage.~      The investigators plan to enrol 245 patients on four hospitals in the Capital Region of~     Denmark during a two year period.~      As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as~     haemostatic monitoring of all participants during the trial: Baseline test is taken at~     inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken~     immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the~     providers of treatment - the rest is clinically available.~   "
129538|NCT01359865|"~     To compare analgesia and orthopedic rehabilitation milestones in patients receiving either~     spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with~     lumbar plexus block.~   "
129539|NCT01359852|"~     The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult~     volunteers.~   "
129540|NCT01359839|"~     The goal of this research is to evaluate whether group therapy combining Relaxation Response~     (RR) training and Cognitive Behavioral Therapy (CBT) in a group format merits further~     investigation in the treatment of Major Depressive Disorder (MDD). Specifically, the primary~     aim of this waitlist-controlled study is to gather preliminary data evaluating the~     effectiveness of RR-CBT group as treatment for patients with current MDD or a history of~     MDD, including patients who continue to be depressed despite taking antidepressants and~     patients who choose not to take antidepressants due to the fear of side effects and/or for~     personal reasons.~   "
129541|NCT01359826|"~     Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting~     the physical, social, psychological health and quality of life of patients. Fatigue and pain~     are aspects of SLE patients which affect their health related quality of life (HRQOL). The~     purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients~     with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to~     determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male~     and female patients, 18 years and older, will be recruited for a 15-week study, in which~     patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo.~     Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and~     placebo groups at the screening visit, baseline visit, week number 6, and week number 14.~     Milnacipran has been shown to be an effective treatment for pain, fatigue and physical~     function in FMS patients. To date, no clinical trials have demonstrated efficacy for the~     treatment of fatigue in SLE patients with concomitant WSP or FMS. The investigators~     hypothesize, based on FMS studies, that the milnacipran treated patients will have less~     fatigue than those in the placebo group. In addition, compared to control arm, those treated~     with the study drug will have less pain and improved quality of life.~   "
129557|NCT01359618|"~     This is a two part study. Part A will determine the maximum tolerated dose of TC-5214~     administered to healthy male subjects in single ascending oral doses. This part of the study~     will define the highest dose of TC-5214 to be administered in Part B. Part B of this study~     will investigate the effect of TC-5214 on the electrical activity of the heart following~     single oral administration. The study will be carried out healthy male subjects in a four~     period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive~     control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.~   "
129558|NCT01359605|"~     The purpose of the study is to characterize the metabolism and excretion (ADME) of a single~     oral dose of [14C]varespladib methyl.~   "
129542|NCT01359813|"~     Patients with cirrhosis present an increased susceptibility to bacterial infections.~     Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe~     circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure~     is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP~     infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of~     renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999).~     However, little is known regarding the effect of albumin administration in patients with~     non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are~     associated with impairment of the effective circulating volume and precipitate renal failure~     whatever the presence of ascites.~      The aim of this randomized clinical trial is to evaluate the effects of albumin, associated~     with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and~     survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and~     presenting with a Child-Pugh score > 8.~   "
129543|NCT01359800|"~     Tat is a key HIV regulatory protein produced very early after infection, prior to virus~     integration, and necessary for viral gene expression, cell-to-cell virus transmission and~     disease progression. Previous studies in natural HIV infection, indicated that the presence~     of a Tat-specific immune response correlates with a lower incidence and reduced risk of~     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune~     response to Tat may exert a protective role and control the progression to AIDS in vivo.~      On the basis of the above mentioned consideration, the present study was directed at~     investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African~     patients.~   "
129544|NCT01359787|"~     The purpose of this study is to evaluate the efficacy and safety of three concentrations of~     a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis~     (AD).~   "
129545|NCT01359774|"~     The purpose of this study is to identify and quantify a brain energy deficit in Huntington~     patients, using 31P-RMN spectroscopy.~   "
129546|NCT01359761|"~     This study will implement and empirically evaluate the efficacy of a cognitive behavioral~     intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service~     members and beneficiaries [with Veterans expected to be added] admitted for inpatient care~     due to severe suicide ideation and/or a recent suicide attempt.~   "
129547|NCT01359748|"~     The purpose of this trial is to determine the accuracy of the Blood Pressure (BP)~     measurement of multifunction KEITO devices under test requirements of the Standard American~     National Standards Institute(ANSI)/Association for the Advancement of Medical~     Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO~     81060-2:2009.~   "
129548|NCT01359735|"~     This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs~     surgery.~   "
129549|NCT01359722|"~     The purpose of this study is to determine the possible effect nephroprotective of~     N-acetylcysteine in patients with chronic kidney disease undergoing elective coronary artery~     bypass grafting by serial evaluation of renal function and to evaluate whether treatment~     reduces cardiac mortality, cardiac events and Global mortality, if it interferes with~     oxidative stress and inflammation and the need for dialysis.~   "
129550|NCT01359709|"~     Cigarette smoking is an important public health concern, and it is most often initiated in~     adolescence. Despite substantial research on smoking cessation in adults, however,~     relatively little effort has focused on therapeutic approaches to reduce adolescent smoking.~      Behavioral interventions, such as contingency management (CM), and pharmacotherapies, such~     as nicotine replacement therapy (NRT), each have some efficacy in reducing adolescent~     smoking, and in adults, combination of behavioral and pharmacological approaches is more~     effective in reducing smoking than either one alone. Little is known about combining these~     therapeutic approaches in adolescent smokers, and research in this area has been hindered,~     in part, by the expense and complexity of large-scale clinical trials of the combined~     treatments and the relative dearth of a cost-effective laboratory procedure. Developing and~     validating a laboratory model to evaluate the combined effects of CM and pharmacological~     adjuncts for adolescent smoking is important because such studies can be conducted more~     rapidly and efficiently, and could provide information on the optimal conditions (e.g.,~     dose) under which pharmacotherapies might augment the positive effects of CM.~      The investigators propose to conduct a randomized, placebo-controlled, double-blind,~     between-groups, 2-week laboratory study. Participants will be randomly assigned to one of~     the following four groups: CM+nicotine patches, CM+placebo patches, noncontingent control~     (NC)+nicotine patches and NC+placebo patches. Fifteen participants will be enrolled in each~     of the four groups, totaling 60 participants. On day 1, participants will arrive to the~     laboratory for a 1-h session. During this session, breath carbon monoxide (CO) levels,~     saliva or urinary cotinine levels will be evaluated. Participants will also complete~     questionnaires on craving, withdrawal and cigarette dependence. Participants will then~     receive seven patches, to wear for seven days, one patch daily. Five sessions during the~     days 8 to 12 will serve as CM or noncontingent sessions, and participants will continue~     wearing patch daily. On these sessions, breath CO levels will be evaluated, and participants~     will have opportunity to receive payments based on their CO levels, according to the group~     assignment. If successful, the proposed study will provide a human laboratory model for use~     in studies of the combined CM and pharmacological approaches for modifying adolescent~     smoking behavior.~   "
129551|NCT01359696|"~     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with~     and without gemcitabine.~   "
129552|NCT01359683|"~     The purpose of this study is to investigate non-linear heart rate variability indexes as~     predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery,~     including coronary artery bypass graft (CABG) and valvular surgery.~   "
129553|NCT01359670|"~     This study, supported by Parent Project Muscular Dystrophy, will determine if tadalafil or~     sildenafil can improve muscle blood flow during exercise in boys with Duchenne muscular~     dystrophy.~   "
129554|NCT01359657|"~     The purpose of this study is to determine 1) the safety and tolerability of multiple~     intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the~     maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or~     Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.~   "
129555|NCT01359644|"~     The purpose of the study is to determine whether therapy with the combination of PSI-7977~     and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C~     virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic~     response with undetectable HCV RNA 12 weeks post treatment~   "
129556|NCT01359631|"~     Hypothesis:~      Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological~     parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.~      Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological~     parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel~     diameter.~   "
129559|NCT01359592|"~     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride,~     vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by~     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy~     x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them.~     Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find~     cancer cells and carry cancer-killing substances to them without harming normal cells.~     Comparing results of diagnostic procedures, such as PET scan and CT scan, done before,~     during, and after chemotherapy may help doctors predict a patient's response to treatment~     and help plan the best treatment.~      PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating~     patients with limited-stage diffuse large B-cell lymphoma.~   "
129560|NCT01359579|"~     The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and~     the safety of varespladib methyl in mild or moderate renal impairment patients and healthy~     volunteers.~   "
129561|NCT01359566|"~     To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to~     placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).~   "
129562|NCT01359553|"~     The purpose of this study is to clarify the potential of intra-articular ultrasound imaging,~     non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and~     arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and~     compared with the arthroscopic findings.~   "
129563|NCT01359540|"~     This study compares the change in bone density which occurs after hip replacement with~     different femoral stem devices.~   "
129564|NCT01359527|"~     This study compares the change (loss) of bone mineral density (BMD) that occurs in the~     proximal femur after hip resurfacing and total hip replacement.~   "
129565|NCT01359514|"~     Mechanism-based choice of therapy for neuropathic pain:~      Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain~     modulation profile?~   "
129566|NCT01359501|"~     This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is~     aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy~     in breast cancer patients.~   "
129567|NCT01359488|"~     The purpose of this research study is to determine the safety and tolerability of up to five~     doses of VRS-317 in Adult Growth Hormone Deficient patients.~        -  Patients will be evaluated for evidence of activity of VRS-317 by measurement of~          changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein~          (IGFBP-3), and bone turnover (bone alkaline phosphatase)~        -  Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and~          IGFBP-3) will be determined by standard model independent methods based on the plasma~          concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg,~          AUC0-inf, and t1/2.~        -  The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range~          (for appropriate age/gender) for IGF-I levels in adult patients for up to one month~          after administration of a single dose~   "
129568|NCT01359475|"~     Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly~     broken down primary teeth since 1950. They are generally considered more expedient to place~     than large multi-surface amalgam or composite restorations and have a longer life. They have~     been used successfully in clinical practice for many years and have presented little in the~     way of adverse events. The major drawback is the poor esthetics along with lingering~     concerns over potential health hazards associated with the nickel content. Several attempts~     have been made to improve upon the esthetics of stainless steel crowns such as veneering the~     buccal and occlusal surfaces and substituting composite resin for the entire crown, but to~     date none of these approaches have been very successful.~      Acetal resin has been used in a number of applications in medicine and dentistry, and~     recently has met with early success when tested as a substitute for stainless steel crowns.~     It has a number of excellent physical and mechanical properties including a low coefficient~     of friction, good wear resistance, high fatigue resistance, good impact strength and~     resistance to creep.~      The purpose of this trial is to compare the clinical performance of preformed acetal resin~     crowns and preformed stainless steel crowns.~      2.0 OBJECTIVES~      The objective of this study is to compare the clinical performance of acetal resin crowns~     with preformed stainless steel crowns when used to restore primary molar teeth.~   "
129569|NCT01359462|"~     For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics,~     pharmacology, and safety of the drug under fasting condition.~   "
129570|NCT01359449|"~     The purpose for this study is to demonstrate the safety and immunogenicity of two doses of~     Menactra® administered between 12 and 18 months of age and concomitantly with routine~     immunization with two different provincial schedule~      Primary Objectives:~        -  To describe the immunogenicity of Menactra® administered concomitantly with routine~          immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants~          (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])~        -  To describe the immunogenicity of MenC administered concomitantly with routine~          immunizations at 12 months of age (measured by SBA-BR)~      Secondary Objectives:~      Safety~        -  To describe the safety profile of Menactra® and MenC vaccines after each dose when~          given concomitantly with routine immunization.~      Immunogenicity~        -  To describe the immunogenicity of both vaccines using serum bactericidal assay using~          human complement [SBA-HC]~        -  To describe the immunogenicity of Pediacel administered at 18 months.~   "
129571|NCT01359436|"~     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor~     for specific EGFR mutation detection in clinical specimens of NSCLC patients, the~     investigators conduct a prospective clinical study. In comparison with results from direct~     sequencing of EGFR, the investigators evaluate the performance of e- Ab sensor, including~     reproducibility, sensitivity, specificity, and cross-reaction (such as detection of EGFR~     mutations other than L858R and DelL746-A750). The potential factors which may interfere with~     the results would be investigated. With such technique, the investigators can obtain EGFR~     mutation information of NSCLC patients in cost-saving and time-saving way and can offer more~     individualized treatment for the investigators patients.~   "
129572|NCT01359423|"~     Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting~     in the treatment of long (≥80 mm) femoropopliteal artery lesions.~      Study design :~        -  Prospective, randomized, multi-center study~        -  A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who~          meet all inclusion and exclusion criteria will be included.~        -  Patients will be randomized in a two by two factorial manner according to the strategy~          of stenting (long versus short stenting) and the additional use of cilostazol. Each~          randomization of the enrolled subjects will be done 1:1.~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Angiographic or CT follow-up will be performed at 1 year.~   "
129573|NCT01359410|"~     The investigators propose a randomized, controlled trial of stapled pancreatic transection~     versus mesh reinforced stapled pancreatic transection. For the duration of the study period,~     participating surgeons will utilize a standardized staple technique. Either a reabsorbable~     polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium~     (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the~     test group. In order to have a uniform test method, the investigators will utilize a~     laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple~     size (4.8mm).~   "
129574|NCT01359397|"~     Background: It is estimated that in the Netherlands each year approximately 900 patients~     with gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for~     chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have~     shown that survival and quality of life are prolonged with chemotherapy. However, no~     chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore,~     tolerability of treatment and ease of administration (outpatient compared to inpatient) are~     important considerations for the development of novel treatment schedules. Study design:~     This is an open-label, multicentre, phase II trial designed to evaluate the efficacy and~     safety of bevacizumab in combination with docetaxel, oxaliplatin and capecitabine~     chemotherapy (B-DOC) as first-line therapy in patients with inoperable locally advanced or~     recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In~     case of HER2 positive inoperable locally advanced or recurrent and/or metastatic~     adenocarcinoma of the stomach or gastro-oesophageal junction trastuzumab is added to this~     regimen (B-DOCT).~      Study Endpoints:~      Primary endpoint Progression free survival defined as the time measured from B-DOCT study,~     Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first~     progression or death. Secondary endpoints Toxicity Overall survival, defined as the time~     from registration to death Response rate defined as the percentage of partial and complete~     responses Duration of response defined as time from response to first progression~     Translational research on pharmacogenomic and biological factors that may predict treatment~     response.~   "
129575|NCT01359384|"~     The purpose of the clinical trial is to gain a more substantial understanding of bronchial~     inflammation in patients with severe primary immundeficiency under immunoglobulin therapy.~     It is intended to characterize the systemical such as the bronchial inflammation (IL-1,~     IL-2, IL-6, IL-8, IL-17, TNF-a, NFkB, IFN-gamma, TGF-beta, TLR2 und TLR4)in children with~     severe immune deficiency in order to generate new treatment strategies based on the results.~      The methods being used for characterization purposes within this trial include specific lung~     function tests ( spirography, bodyplethysmographie w. helium) such as the analysis of eNO~     and eCO. Furthermore, sputum and serum samples are being analyzed by quantitative real-time~     polymerase chain reaction (PCR),(qRT-PCR) and by cytometric bead assay (CBA). Components of~     the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant~     proteins) are genetically determined from sputum or blood respectively. In the conduct of~     the study the investigators will retrospectively and systematically evaluate the available~     high-resolution computed tomography (HRCT) studies of affected patients.~   "
129576|NCT01359371|"~     The purpose of this study is to evaluate the peer telephone cessation counseling that has~     been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics~     intervention.~   "
129577|NCT01359358|"~     This project has as general objective to determine if there is any Methicillin-resistant~     Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this~     is the case, the investigators will determine if this is an international known strain by~     typing it by PFGE and MLST.~      The detection of mecA gene will be performed by PCR. Their susceptibility profile to several~     drugs will also be accessed and it will be possible to compare the response to those drugs~     commonly in use to that of Daptomycin, a new drug available in Brazil.~      It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in~     order to search for VISA or hetero-VISA. Also, due to the discussions at the literature~     about mutations in genes that are said to be responsible for reduced susceptibility to~     vancomycin, the investigators will sequence these genes in all PFGE type strain of this~     study looking for mutations already described to compare to the screening results.~   "
129578|NCT01359345|"~     Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with~     severe renal failure mainly in patients under dialysis in whom gadollinum is being used.~      The investigators will evaluate the prevalence and severity of NSF in patients with~     different degree of renal failure whom underwent imaging with Gadolinum.~   "
129591|NCT01359176|"~     Capnography is the non-invasive monitoring of the concentration or partial pressure of~     carbon dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring~     technique which allows fast and reliable insight into ventilation, circulation and~     metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or~     partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial~     blood. The purpose of this study is to create a waveform library by collecting CO2 waveform~     data from healthy volunteers.~   "
129592|NCT01359163|"~     A pivotal study to determine bioequivalence between a the current marketed formulation of~     Femulen tablets and reformulated Femulen tablets in healthy female subjects.~   "
129593|NCT01359150|"~     A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response~     Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid~     Arthritis receiving CP-690,550 with and Without background Methotrexate~   "
129594|NCT01359137|"~     This is a Cochise County experiment with innovative probation supervision practices.~     Subjects are assigned to one of three supervision conditions.~   "
129579|NCT01359332|"~     Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population~     has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall~     morbidity and mortality associated with convulsive SE (CSE) is 60% at three months. The~     alteration of functional prognosis of these patients is more conventionally attributed to~     the cause than to CSE itself. Longer seizure duration, progression to refractory status~     EPILEPTICUS and presence of cerebral insult are strong factors independently associated with~     a poor functional outcome. These three factors offer may be amenable to improvement and hope~     for preventive strategies. Current guidelines recommend the use of anticonvulsant treatment~     whose goal is prompt cessation of clinical and electrical seizures. None of these treatments~     has demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and~     34 ° C) showed interest in neuroprotection of post anoxic coma patients after a~     cardiovascular arrest on ventricular fibrillation by reducing morbidity and mortality in~     about 20% without major side effects. This technique has been used successfully in various~     pathologies such as stroke or traumatic brain injury. Pathophysiological mechanisms involved~     in epileptogenesis and neurotoxicity induced by persistence of seizures can be blocked by~     therapeutic hypothermia. Recent work on experimental models of SE demonstrated~     neuroprotective and anticonvulsant interest of therapeutic hypothermia. Therapeutic~     hypothermia has also been successfully used in some cases of particularly refractory CSE.~     Its early use in patients with SE would have a double interest: neuroprotective and~     anticonvulsant. There is currently no published studies or ongoing to determine the interest~     of its early use in patients with CSE.~   "
129580|NCT01359319|"~     Hereditary Inclusion Body Myopathy (HIBM) is a severe progressive metabolic myopathy caused~     by a defect in the biosynthetic pathway for sialic acid (SA), a critical component of many~     muscle proteins, resulting in a deficiency in SA in the muscles of HIBM patients.~      The effective replacement of the missing SA substrate is theoretically simple, and, in~     animal models, replacement with SA showed significant restoration of sialylation~     biochemistry and excellent reduction in muscle disease. These data show that replacement can~     achieve significant clinical benefit in muscle pathology, function, and survival.~   "
129581|NCT01359306|"~     The purpose of this study is to determine the predictors of right ventricular damage (RVD)~     assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement~     (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI)~     and its prognostic significance.~      The investigators hypothesize that ischemia related changes of the myocardium are also~     visible in the right ventricle and that they have an impact on patient outcome.~   "
129582|NCT01359293|"~     The primary objective of this study is to compare the effects of paliperidone versus oral~     antipsychotics on changes in brain parenchymal volume, number of relapses, and time to~     relapse during a one-year period of follow up of patients with new onset schizophrenia.~   "
129583|NCT01359280|"~     Persistent adherence to antiretroviral therapy is necessary for the successful treatment of~     HIV infection. The proposed research will test a theory-based behavioral intervention that~     includes objectively monitoring HIV treatment adherence with corrective feedback delivered~     by cell phone. The study will also test the independent effects of an automated text message~     reminder system for sustaining adherence improvements. The intervention under study has~     utility for people living with HIV/AIDS In resource limited rural and urban settings.~   "
129584|NCT01359267|"~     The purpose of this study is to obtain preliminary information on the potential of 99m~     Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.~   "
129585|NCT01359254|"~     The primary objective of this study is to assess the rate of engraftment with combined~     haploidentical-cord blood transplantation in patients with pre-existing donor specific~     antibodies and in those with active disease.~   "
129586|NCT01359241|"~     The main objective of this study is to evaluate the efficacy and safety of 24 hours of~     closed-loop glucose control compared with standard diabetes treatment, in patients with type~     2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied~     as it is representative of patients with glucose dysregulation.~   "
129587|NCT01359228|"~     The purpose of this study is to determine the effects of rifaximin on skin symptoms in~     patients with rosacea by double-blinded, placebo-controlled, crossover study.~   "
129588|NCT01359215|"~     The purpose of this study is to determine whether pediatric anesthesia is associated with~     long-term hippocampal dysfunction~   "
129589|NCT01359202|"~     This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres.~     Patients coming to the emergency department with bleeding in the brain not due to trauma or~     other known causes who can be treated within 6 hours of onset will undergo CT angiography~     using standard CT scanners (CAT scan). Those with a spot sign, a type of marker on the~     CT scan that shows the brain is still bleeding, will be randomly assigned to a single~     injection of factor 7(a blood clotting drug used in hemophilia) or placebo (inactive~     saline); patients without a spot sign will not be treated. The researchers will look at how~     much bleeding happens after the treatments are administered, as well as clinical outcomes~     such as death and disability. The researchers think that factor 7 will cause the bleeding to~     stop faster and possibly decrease death and disability.~   "
129590|NCT01359189|"~     This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe~     scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent~     (ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small~     cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal~     ultrasound (TRUS) developed by Hybridyne Imaging Technologies, Inc.To explore the adjunctive~     benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland~     utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as~     normal controls. Prostate cancer sextant biopsy histology results will be correlated with~     ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe~     and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific~     ProstaScint® uptake in primary prostate cancer.~   "
129654|NCT01358344|"~     The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high~     percentage of drug as the free base are equivalent to tablets with the standard percentage~     when given to participants.~   "
129595|NCT01359124|"~     The primary objective is to evaluate water based treadmill exercise, land based treadmill~     exercise, and upright cycling in meeting American College of Sports Medicine exercise goals~     for moderate exercise.~      The secondary objective is to compare exercise tolerance for water based treadmill, land~     based treadmill, and upright cycling in meeting American College of Sports Medicine exercise~     goals for moderate exercise.~      The tertiary objective is to evaluate quality of life improvements for water based treadmill~     exercise, land based treadmill exercise, and upright cycling.~   "
129596|NCT01359111|"~     The purpose of this study is to evaluate whether an investigational vaccine delivery device~     (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the~     skin.~   "
129597|NCT01359098|"~     The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3%~     Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment~     of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7~     days.~   "
129598|NCT01359085|"~     Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain~     and discomfort. Many analgesic protocols have been proposed for pain relief following RC~     repair and controversy remains regarding the optimal postoperative analgesic protocol.~     Despite significant advancement in analgesic techniques over the last decades 50-70% of~     patients who undergo surgical procedures still experience moderate to severe postoperative~     pain. Postoperative pain has both inflammatory component (i.e. related to traumatic tissue~     damage and inflammatory reaction due to the surgical incision and procedure) and neuropathic~     component (i.e. related to over sensitization of the peripheral and central nervous system).~     Opioids are commonly used for postoperative pain reduction, however their use is associated~     with numerous adverse events and should be limited.~      Regional nerve block techniques have been emerged over the past decade and have become a~     standard of practice recently. Recent studies indicate that a single-dose interscalene~     brachial plexus block (ISBPB) is effective in providing postoperative analgesia following~     shoulder surgery, reduces the need for opioid medication, and has a very high success rates~     (≥94%) and few major complications (≤0.4%). However, regional nerve blockade, including~     ISBPS, has a frequent incidence of temporary postoperative neurological symptoms within the~     first postoperative week (4 -16%), is technically demanding and might be time consuming.~      Pregabalin (Lyrica) is an anticonvulsant drug with membrane stabilizing and anti-nociceptive~     effects commonly used for neuropathic pain relief and anxiety disorder. It desensitizes the~     presynaptic terminals of hyperexcited neurons in peripheral and central nervous system (i.e.~     reduces the transmission of excitatory neurotransmitters including glutamate,~     norepinephrine, substance P, and calcitonin gene-related peptide) by reducing calcium influx~     through high-voltage-activated calcium channels containing the alpha2/delta subunit.~     Pregabalin is rapidly absorbed from the gut with bioavailability of approximately 90%,~     achieves peak plasma concentration approximately 1h after administration, has half-life of~     about 6h and is eliminated by renal excretion. Many studies over the past decade have~     evaluated pregabalin roll in the treatment of acute postoperative pain. Pregabalin effect in~     reducing opioid consumption and opioid adverse events (AEs) has been well established. Its~     analgesic effect on acute postoperative pain remains questionable, and further studies are~     still required to compare pregabalin analgesic potential with other standard post-operative~     analgesic regimens. Pregabalin doses used in previous studies ranged from 75 to 600 mg given~     as a single dose 1-2h preoperatively with or without additional doses at 12h and 24h~     postoperatively. Doses of 150 mg and higher seemed to offer better results in terms of~     postoperative analgesia and opioids sparing. However higher doses were associated with~     higher rate of AEs, mainly sedation, dizziness and visual disturbances.~      Nervous system desensitization by oral medication (e.g. pregabalin) rather than by invasive~     means (e.g. ISBPB) may reduce adverse reactions, increase patient satisfaction and save~     valuable time in the operation theater. To the investigators knowledge no previous study has~     compared the efficacy of pregabalin to ISBPB for acute pain relief following arthroscopic~     shoulder surgery. The investigators hope to contribute to the discussion regarding the~     optimal pain relief method following arthroscopic shoulder surgery.~   "
129599|NCT01359072|"~     -  Approximately 30% of all patients with cancer report levels of psychological distress~          indicative of the need for psychological intervention.~        -  Research suggests that learning more adaptive coping strategies improves psychological~          adjustment to cancer.~        -  It is imperative to develop cost-efficient, feasible psychosocial interventions.~        -  The aim is to test the efficacy of the self administered format of a psycho-educational~          intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for~          cancer patients.~      It is hypothesized that:~        -  patients would show significant reductions in distress (i.e., depression and anxiety)~          over the 6-week treatment period, and that treatment would produce superior results~          compared to wait-list; patients would maintain or even increase their improvement up to~          3 months following treatment.~        -  the treatment would enhance more adaptive coping strategies.~        -  greater self-reported adherence to the treatment/homework would be associated with~          symptom improvement, more autonomous self-regulation and higher perceived competence~          for adhering to the coping intervention program.~   "
129600|NCT01359059|"~     Hypothesis~      No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only~     administration. The investigators believe that the administration of PGL preemptively would~     diminish pain sensation and therefore the need for opioids administration in~     orthopedic-oncologic patients more effectively than if administered starting~     postoperatively.~   "
129601|NCT01359046|"~     Urinary catheters are used routinely in the postoperative care of urogynecology patients~     after surgery involving the genitourinary tract. However, Urinary tract infections(UTI)~     associated with indwelling catheter is the second leading cause of nosocomial infections.~     20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.~      There are many different types of catheters available for use. Standard indwelling catheters~     are made from a variety of materials including polyvinyl chlorine, plastic, plain latex,~     polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer.~     Specialized catheters have been developed with the aim of reducing infection. Strategies~     generally involved coating the inner, outer or both surfaces of the catheter with~     antimicrobial materials. These materials can be antibiotic or antiseptic with the most~     common antiseptic material used being silver. Silver ions are bactericidal, are used safely~     when applied topically to humans and used in controlling infections.~      Previous studies comparing UTI rates in transurethral catheters have reported a significant~     reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard~     catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy~     supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that~     this study will show a statistically significant decrease in UTI rate among the individuals~     with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.~   "
129602|NCT01359033|"~     The study aims to investigate the differences in survival trajectories and hospital~     variability in myocardial infarction (MI) mortality rates in the UK and Sweden.~   "
129603|NCT01359020|"~     The purpose of this study was to compare the efficacy and tolerability of acetaminophen,~     dipyrone and ibuprofen to fever control in children.~      For the efficacy asses were compared:~        -  the time to start the action;~        -  the action duration;~        -  the difference between the basal temperature and the lower temperature in the study~          period.~      For the tolerability asses all adverse events were recorded, as well as your intensity and~     the relation to the treatment.~   "
129604|NCT01359007|"~     The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and~     the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging~     sufficient to allow surgical resection, could improve the overall survival of patients with~     locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic~     cancer, a phase II study of this regimen in patients with locally advanced unresectable and~     borderline pancreatic cancer is planned to determine the rate of conversion to operability.~   "
129605|NCT01358994|"~     From a central registry at the National Board of Health and Welfare in Sweden collect all~     patients in the city of Malmö prescribed metformin during two years. Glomerular filtration~     rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control~     material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU~     admission were also sought. The study hypothesis is that metformin is prescribed to patients~     with lower GFR than anticipated with very few cases of lactic acidosis registered.~   "
129606|NCT01358981|"~     This will be the first study in which LY2881835 is given to humans in order to evaluate the~     safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in~     the body and its effect on blood sugar levels.~      The study consists of two parts. In part A, healthy subjects will participate and in part B,~     patients with type 2 Diabetes Mellitus (T2DM) will participate.~   "
129669|NCT01358149|"~     Today, there is an important lack of knowledge on child metabolism and the effects of~     phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods.~     Here, the investigators will monitor the metabolism of children using minimally invasive~     techniques at rest, and with physical/mental activities and assess the changes associated~     with the intake of cocoa-based food.~   "
129607|NCT01358968|"~     The purpose of this study is to assess the effect LY2603618 on a protein (enzyme CYP2D6)~     which is involved in the metabolic pathway of Desipramine in patients with cancer. This is a~     drug interaction study so the treatment of the disease will not be the main purpose of the~     study.~      The study involves two single doses of 50mg, 1 tablet by mouth, on Day 1 of Period 1 and 2.~     In Period 1 Desipramine will be administered alone, In Period 2 Desipramine will be~     administered in combination with LY2603618. LY2603618 will be administered as a 275mg IV~     infusion over 1hr.~      Desipramine will be administered at the end of the LY2603618 infusion. Information about any~     side effects that may occur will also be collected.~   "
129608|NCT01358955|"~     -  There will be a significant difference in cognitive function between cognitive~          intervention group (group therapy) and a wait list control group.~        -  There will be a significant difference in cognitive function between a home-based~          cognitive intervention group and a wait list control group.~   "
129609|NCT01358942|"~     This prospective observational study will evaluate the evolution of lung cancer related~     symptoms and their correlation with the disease control rate (complete response, partial~     response and stable disease) in patients with non-small cell lung cancer initiating~     first-line treatment with standard platinum-based chemotherapy with or without Avastin~     (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of~     chemotherapy.~   "
129610|NCT01358929|"~     This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive~     multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is~     8 weeks.~   "
129611|NCT01358916|"~     Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a~     major driving force for the development of resistance. Thus optimization of antibiotic~     prescription and reduction of unnecessary antimicrobial treatment are essential in the~     prevention and reduction of antimicrobial resistance rates.~      The goal of this study is the improvement of antibiotic prescription in outpatient care. The~     study will take place within a Swiss-wide sentinel surveillance network of physicians. The~     participating physicians will be randomised in a control and intervention group. The~     intervention group will receive therapeutic guidelines for the treatment of upper and lower~     respiratory tract infections and lower urinary tract infection as well as regular feed-backs~     on the prescription pattern of the sentinel physicians during the past months. Sentinel~     physicians will collect information about each antibiotic prescription, its indication and~     characteristics of the patient.~      Our hypothesis is that the prescription pattern in the intervention group will be optimised~     and unnecessary antibiotic therapy will be reduced compared to the control group.~   "
129612|NCT01358903|"~     This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and~     efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing~     malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously~     at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1~     and/or 2, followed by RO5429083. For all patients there will be an option to continue~     treatment with RO5429083 until disease progression or unacceptable toxicity occurs.~   "
129613|NCT01358890|"~     -  The primary aim of this study is to determine the adherence of low- carbohydrate among~          Chinese.~        -  Then compare the effect of low-carbohydrate and traditional Chinese but~          restricted-calories diet on weight loss and metabolic traits.~   "
129614|NCT01358877|"~     This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and~     efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in~     participants with operable HER2-positive primary breast cancer. After surgery, participants~     will be randomized to receive either pertuzumab or placebo intravenously (IV) every 3 weeks~     (q3w) for one year, along with 6-8 cycles of chemotherapy and 1 year of trastuzumab IV every~     3 weeks. This study will be carried out in collaboration with the Breast International Group~     (BIG).~   "
129615|NCT01358864|"~     The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12~     or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV~     alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV~     treatment.~   "
129616|NCT01358851|"~     The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to~     cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch~     biopsies).~   "
129617|NCT01358838|"~     Rationale: Scars can be highly disfiguring and may result in functional impairment and~     psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a~     promising novel treatment modality for scars.~      Objectives: The primary objective of this study is to assess the efficacy and safety of~     10600 nm FLT for the treatment of different types of scars.~      Study design: Prospective observer blinded randomised controlled split-lesion trial.~      Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or~     atrophic scars who give written informed consent.~      Methods: Two similar test regions of the scar will be randomly allocated to either 3~     sessions of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no~     treatment.~      Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome~     variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment~     of the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy,~     pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by~     reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects participating in the study will be requested to visit the SNIP~     (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit~     will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a~     10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the~     device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema~     (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm~     (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this~     laser device.~      All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires~     local anesthesia. The amount of topical anesthetic used for infiltration is low~     (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side~     effects due to the anesthetic agent.~      All together the burden due to the study is moderate, side effects are generally local and~     mild. Systemic side effects are not reported with this treatment. There is an indirect~     benefit for the participating subject. In case of improvement of the treated test regions,~     this therapy can be directly utilized to treat the whole scar.~      Considering the relative lack of alternative treatment options in many of these scars, the~     balance between burden, possible side effects and prospect for improvement is very~     favorable.~   "
129618|NCT01358825|"~     The aim of this study is to assess antibody persistence in infants who received three doses~     of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11~     months of age in study NCT00307034.~   "
129619|NCT01358812|"~     The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in~     a phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible~     and associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other~     RAS rare mutations have been suggested as additional potential biomarkers for anti-EGFR~     agents in metastatic colo-rectal cancer. The present study aims to demonstrate the~     feasibility and the activity of the first-line combination of the GONO-FOLFOXIRI regimen and~     Panitumumab in molecularly selected metastatic colo-rectal cancer patients.~   "
129620|NCT01358799|"~     The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay~     for Chlamydia trachomatis (CT; ACT Assay), which is cleared for use on the TIGRIS DTS~     (Direct Transfer) System (TIGRIS System), can be tested on the PANTHER System. The~     intended use of the ACT Assay will be unchanged except for the inclusion of its use with the~     PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on~     the TIGRIS System.~   "
129621|NCT01358786|"~     Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are~     used for membership (between the aponeurosis of the abdominal flap and underlying muscles)~     for closing the donor area, where there is reduced incidence of complications.~   "
129622|NCT01358773|"~     Obese adolescents are submitted to a multiprofessional weight loss program, which is formed~     by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers~     have intervention 3 times a week during one year, where they practice exercises, have~     nutrition and psychology counseling, and physiotherapy orientation. Once a month they have~     an appointment with the doctor. The hypothesis of this study is that a multiprofessional~     therapy is able to improve anthropometric and biochemical parameters, and also the quality~     of life of obese adolescents.~   "
129623|NCT01358760|"~     The purpose of this Phase III trial is to evaluate the efficacy of intravaginal~     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.~   "
129624|NCT01358747|"~     All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is~     hoped that patients will achieve a good response to both induction therapies consisting~     either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide,~     Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD~     (Adriamycine, Bléomycine, Vinblastine, Décarbazine).~      The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy~     (PET2) in the experimental arm will help to stratify patients in order to restrict the~     BEACOPPesc therapy continuation to those patients who achieved only a partial response after~     2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2~     negative patients. For all patients included in the trial the achievement of a good response~     to induction treatment will be checked after four cycles of induction treatment including a~     centrally reviewed PET assessment~      Patients will be randomized after verification of eligibility and before the start of the~     protocol treatment.Patients will be randomly assigned to the standard treatment arm not~     monitored by early PET, or the experimental treatment arm driven by the PET2 result.~   "
129625|NCT01358734|"~     The study aim is to compare safety and efficacy of high-dose lenalidomide regimen,~     sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with~     newly-diagnosed acute myeloid leukemia (AML).~   "
129626|NCT01358721|"~     The purpose of this study is to evaluate the pharmacodynamic and biologic properties of~     BMS-936558 in subjects with metastatic renal cell carcinoma.~   "
129627|NCT01358708|"~     Irritable bowel syndrome is a complex condition with a high unmet medical need for effective~     and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and~     symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a~     potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome~     (IBS-D).~   "
129628|NCT01358695|"~     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of~     ANT-1207 in the treatment of Crow's Feet.~   "
129629|NCT01358669|"~     Although hip replacement surgery is a successful way of dealing with the pain and immobility~     caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10~     years. The main reason for this is the development periprosthetic osteolysis, that is, loss~     of bone around the site of the hip replacement. The osteolysis is thought to be due to the~     small particles of debris worn from the surfaces of the hip implant. These particles cause a~     reaction in the blood cells around the joint which in turn affects bone cells and leads to a~     loss of bone around the implant. The joint implant will then eventually become loose and~     unstable, a condition known as aseptic loosening. At present the only way to treat aseptic~     loosening is to have another operation to secure the hip joint, known as revision surgery.~     Revision surgery is not always successful and exposes the patient to the risk of major~     surgery.~      In this study we explore the potential for giving a medication (denosumab) that may prevent~     the loss of bone around the hip replacement implant. We will recruit patients who have been~     listed for revision surgery. One group of patients will be given a single dose of denosumab;~     another group will be given a placebo (dummy drug). At the time of the revision surgery a~     small sample of the bone from around the hip replacement will be taken and examined under~     the microscope. Comparisons will be made between the patients having the denosumab and those~     having placebo to find out whether the denosumab is having a beneficial effect on the bone~     surfaces. If successful, this study will lead to further studies to develop the use of~     denosumab to prevent aseptic loosening.~   "
129630|NCT01358656|"~     Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last~     20 years. However, data in the literature reveal that approximately 15-25% of patients~     undergoing surgery still do not present optimal outcomes, which suggests that there is room~     for improvement of the procedure. A possible explanation for this fact is that most ACL~     reconstructions consider only one of the functional bundles of the ligament. Our hypothesis~     is that the ACL reconstruction with the double-bundle technique will be effective in~     reducing the patients' rotation of the knee joint for high-demanding tasks compared to the~     patients who had ACL reconstruction with the single-bundle technique.~   "
129803|NCT01356407|"~     Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or~     polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its~     effectiveness, tolerability and safety.~   "
129631|NCT01358643|"~     The purpose of this pilot is to assess the feasibility and potential effectiveness of three~     specific e-health approaches. One approach, SparkPeople.com, involves the use of social~     media and can be accessed through a free website. This approach has the potential to provide~     support through an on-line community as well as a number of diet/weight and physical~     activity related tools. A mobile phone application is also available for those with smart~     phones. The second approach, BodyMedia, involves the use of an objective monitoring device~     that tracks all activity. This information can be uploaded to a website to provide ongoing~     monitoring and feedback about activity and energy expenditure. The third approach, P90X,~     involves a DVD based resistance focused exercise program. While DVD programs are not~     necessarily considered e-health, participants will be encouraged to participate in online~     community forums associated with the program. All participants, regardless of randomization,~     will be given 4 point of decision prompts that are laminated 8.5x11 posters encouraging~     healthier behaviors to display in various areas of their home.~      The specific aims are:~        1. To assess the effect of the intervention on weight, activity levels, depression, and~          adherence.~        2. To determine level of interest, perceptions, feasibility and satisfaction of the~          proposed interventions (i.e. SparkPeople.com vs. BodyMedia vs. P90X) with particular~          attention to: 1) social media; 2) food logs; 3) objective monitoring of physical~          activity; 4) use of point systems~   "
129632|NCT01358630|"~     The purpose of this study is to analyze genetic polymorphisms in genes encoding~     pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis~     (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The~     investigators will also try to identify oral bacteria in atherosclerotic plaques and~     aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and~     aneurysmal wall will be performed.~   "
129633|NCT01358617|"~     This research study is studying biomarkers in tumor tissue samples from young patients with~     neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may~     help doctors identify biomarkers and learn more about biomarkers related to cancer~   "
129634|NCT01358604|"~     RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study studies biomarkers in samples from young patients with~     neuroblastoma.~   "
129635|NCT01358591|"~     The purpose of this study is to assess the effect of a high calcium breakfast on substrate~     metabolism during exercise and appetite throughout the day.~   "
129636|NCT01358578|"~     This study will assess the safety and efficacy of secukinumab compared to placebo and~     etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.~   "
129637|NCT01358565|"~     This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic~     dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.~      An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9~     subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by~     a group of 9 healthy volunteer subjects with normal hepatic function who are comparable in~     age, gender, and weight to the hepatically impaired subjects will be enrolled to receive a~     single oral 20 mg dose of Fx-1006A each.~      Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to~     determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that~     hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a~     group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be~     enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with~     normal hepatic function may be enrolled to ensure appropriate demographic matching to the~     mild hepatically impaired subjects, with respect to age, gender, and weight.~      During Screening, subjects will provide written informed consent to participate in the study~     and be reviewed against the study entrance criteria (including assessment of hepatic~     function) to determine eligibility. All subjects will provide blood and urine samples for~     clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.~      Subjects who meet the entrance criteria during Screening will check in to the clinical site~     1 day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance~     criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose~     assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following~     day (water is allowed).~      The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator~     or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing~     (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample~     collection.~      Subjects will be discharged on Day 2, after they have completed the study procedures and the~     Investigator has determined that the subject is clinically stable. Subjects will return to~     the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety~     evaluations and PK sample collection. Day 16 will be the end of study visit.~   "
129638|NCT01358552|"~     This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA®~     are invited to participate in surveys about their pregnancy and experiences with~     Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of~     L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with~     personalized education and support during their pregnancies, and contribute to the overall~     understanding of the needs and concerns of women facing intermediate- to high-risk~     pregnancies.~   "
129639|NCT01358539|"~     Rationale: Although radiotherapy is an effective palliative treatment for patients with~     painful bone metastases with over 70% responders, pain intensity is not always sufficiently~     controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients~     show that during weekly follow up, 35% of the patients remain above a pain intensity level~     of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO~     criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline~     'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain~     control. However, the effect of a nurse-led education of patients undergoing palliative~     radiotherapy for painful bone metastases has not been investigated yet.~      Objective: This project investigates whether nurse-led pain education in addition to~     standard care results in better control of pain in patients referred for palliative~     radiotherapy.~      Study design: A national multicenter phase 3 study (n=450).~      Study population: Patients with painful bone metastases referred for short schedule~     radiotherapy.~      Intervention: Patients will be randomized between standard care or standard care with the~     Pain Education Program, a nurse-led pain education. The pain Education Program will be~     provided on the same day the radiotherapeutic treatment will start. The nurse will first~     assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will~     be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses~     will telephone patients at regular intervals during follow-up to monitor their needs.~      Main study parameters/endpoints: The primary outcome of this randomized multicenter study is~     a decrement of the number of patients whose worst pain intensity remains above 4 at any time~     during the 12 weeks of follow up with regard to the control group. The secondary outcome is~     improvement of quality of life.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and~     the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.~   "
129640|NCT01358526|"~     The primary objective of this study is to assess the efficacy and safety of OXN compared to~     placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back~     pain who require around-the-clock opioid therapy.~   "
129682|NCT01357980|"~     The purpose of this study is to determine the efficacy and safety of a single dose of 750 U~     of Dysport compared to placebo for the improvement in the daily incontinence episode~     frequency for each administration mode in subjects suffering from neurogenic detrusor~     overactivity following spinal cord injury or multiple sclerosis.~   "
129641|NCT01358513|"~     The aortic valve is the main outlet valve from the heart. This valve can become diseased and~     narrowed when it needs to be replaced with an artificial valve. Currently, this is the~     commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately,~     there are no medical treatments that can prevent or delay the progression of this disease~     process. Here, the investigators propose to use new state-of-the-art imaging techniques to~     better understand the disease process so that the investigators can effectively design and~     assess potential new treatments. The ultimate aim is to stop this disease before patients~     need to have surgery. In addition the investigators believe this technique will allow us to~     predict the rate of progression of the disease~   "
129642|NCT01358500|"~     This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect~     and safety profile in opioid-dependent patients. The investigators anticipate that a well~     tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be~     related to the patient's maintenance opioid dose.~   "
129643|NCT01358487|"~     The purpose of the study is:~        1. to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate~          in an online study to prevent clinical depression and~        2. to estimate the percentage of participants who will complete online assessments at 1,~          3, and 6 months when receiving either a) email reminders + monetary online incentives~          or b) email reminders + monetary incentives + phone calls.~      NOTE: RECRUITMENT IS COMPLETED.~   "
129644|NCT01358474|"~     The purpose of this study is to determine if participants have changes in dopamine cells in~     their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease~     (PD) and other degenerative Parkinsonian disorders, but does not occur in most other~     movement disorders such as essential tremor or dystonia. DaTSCAN, which is also known as~     123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has~     been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in~     dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a~     few hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where~     there are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of~     radioactive iodine, it allows doctors to use a special machine called single photon emission~     computed tomography (SPECT) scanning to detect the location and amount of radioactivity in~     the brain and help determine if there are changes in brain dopamine. It is hoped that this~     study will help doctors detect the presence of dopamine changes even before symptoms are~     present. This study will evaluate DaTSCAN in people with PD, those who are at risk for~     developing PD (e.g., those with idiopathic rapid eye movement sleep disorder (iRBD) and~     those who are heterozygous or homozygous for Gaucher's disease (GBA) mutations) and those~     who are healthy volunteers.~   "
129645|NCT01358461|"~     Context~      The investigators recently demonstrated a highly significant increase in muscarinic receptor~     density in the myocardium of infants deceased from sudden infant death syndrome (SIDS)~     compared to those of infants deceased from identified causes 1. Muscarinic receptor~     overexpression was found in all SIDS samples studied to date. It was associated with an~     average increase in acetylcholinesterase activity, appearing as a compensatory mechanism to~     oppose the cardiac muscarinic receptor overexpression. Similar vago-cardiac abnormalities~     were detected in a rabbit model of vagal hyperreactivity that the investigators first~     described some years ago2. In these hyperreactive animals, expression of muscarinic~     receptors was also enhanced in blood white cells. Noticeably, the pattern of changes in~     these cells paralleled the pattern of changes in the heart. Thus, muscarinic abnormalities~     in cardiac tissues could be inferred with high confidence from those measured in~     lymphocytes.This was the first report of a vago-cardiac abnormality in sudden infant death~     syndrome. The investigators findings also provided original and important perspectives for~     the identification and therapeutic management of infants at risk of sudden death. As such,~     the publication of the investigators work raised a major interest from the population and~     from the scientific and medical communities, in particular cardio-pediatricians.~     ObjectivesThe objective of the present clinical project is to validate, in human~     lymphocytes, muscarinic receptor expression level (assessed by quantitative RT-PCR) as a~     circulating biomarker of autonomic nervous system dysfunction and more specifically, of~     vagal hyperactivity and of risk of sudden death. The project will include 2 major items,~     conducted in parallel:1. evaluation of the muscarinic receptor expression in lymphocytes~     from adults with vagal syncopes (n=60 patients from an existing file versus 60 controls)~     (Cardiology unit + Clinical Investigation Centre (CIC) + Laboratory of Neurobiology and~     Cardiovascular Pharmacology); 2. evaluation of the muscarinic receptor expression in~     lymphocytes from children with vagal syncopes (n=60 versus 60 controls) (Pediatry unit +~     Clinical Investigation Centre + Laboratory of Neurobiology and Cardiovascular~     Pharmacology).PerspectivesThis project represents the first step of validation of a~     circulating marker of vagal hyperactivity and of risk of SIDS in human. Once this step is~     completed, the investigators will start with the prospective study  muscarinic receptor~     expression in lymphocytes and SIDS  (cord blood collected at birth and follow up of the~     new-borns) (Maternity ward + CIC + Laboratory of Neurobiology and Cardiovascular~     Pharmacology). Then therapeutic preventive management becomes a realistic objective. A~     therapeutic clinical study will then be started with atropinic drugs, in order to test their~     potential protective action against sudden death. The final objective of the investigators~     research is the prevention of SIDS through i) identification - as soon as birth - of~     new-borns at high risk and ii) appropriate prophylactic therapy. The investigators work also~     opens exciting perspectives in the field of the still poorly understood vagal disorders in~     children and adults such as vagal pauses.1 Livolsi et coll, Plos One 5, e9464, 2010 ; 2~     Livolsi et coll, Circulation 106, 2301-2304, 2002~   "
129646|NCT01358448|"~     In 2007 the Expert Committee published recommendations on the prevention and treatment of~     childhood obesity. These recommendations outlined four interventions intended for~     advancement based on the child's age, body mass index (BMI), and response to treatment. The~     initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses~     on primary care providers monitoring growth monthly and delivering intervention messages~     that target dietary and leisure-time behaviors that most contribute to energy imbalance in~     children. Little research has evaluated the efficacy of these recommendations. Thus the~     primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus~     stage for treating childhood overweight and obesity in a primary care setting. As the cost~     of interventions is a large barrier to the translation of evidence-based research into~     primary care settings, a second goal of the project is to evaluate program~     cost-effectiveness.~   "
129647|NCT01358435|"~     The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30~     with regard to its total and to its maximum serum insulin concentrations.~   "
129648|NCT01358422|"~     Research questions:~        1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE)~          associated with the use of dual anti-platelet therapy as compared with aspirin alone in~          this population?~        2. What is the absolute risk increase for clinically significant bleeding during the same~          period associated with the use of dual anti-platelet therapy as compared with aspirin~          alone in this population?~      In brief the design of the study is as follows:~        -  We will study patients undergoing non-cardiac surgery within four years of coronary~          stenting.~        -  We will record the anti-platelet agents taken by patients before, during and after~          surgery.~        -  We will record cardiac and bleeding events that occur whilst the patient is in~          hospital.~        -  We will use the statistical technique of propensity scoring to match patients who have~          similar risk factors and who received different anti-platelet regimens.~        -  We will compare the incidence of cardiac events and bleeding in the matched groups.~   "
129649|NCT01358409|"~     Within large number of patients with obesity, it is crucial to determine who is at the~     greatest risk for development of chronic heart disease. The investigators previous studies~     suggest that an excessive accumulation of fat in heart cells precedes the development of~     obesity-related pathologies and may serve as a biomarker of heart disease in high-risk~     population. Until now, the evaluation of fat in the human heart was possible postmortem or~     by biopsy. The investigators novel magnetic resonance spectroscopy technique enables the~     quantification of intracellular lipid content non-invasively and repeatedly in humans in~     vivo. It could be used to better screen and treat obese patients at risk for the development~     of metabolic disease. The investigators hypothesize that in obese humans with elevated~     myocardial triglycerides, treatment with Nebivolol will reduce myocardial fat and will~     improve heart function.~   "
129650|NCT01358396|"~     Does diabetic patients' glycemic control affect their response to laser and/or intravitreal~     injection therapy in terms of visual and anatomical outcomes.~   "
129651|NCT01358383|"~     This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult~     volunteers.~   "
129652|NCT01358370|"~     This is a Natural History study to characterize key aspects of the clinical course of~     lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.~   "
129653|NCT01358357|"~     This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study~     designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or~     divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without~     rapid cycling and /or psychotic features.~   "
129655|NCT01358331|"~     This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given~     as single agent oral therapy for participants with advanced solid tumors will be done into~     two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum~     tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2~     dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants~     with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to~     see if MK-8353 is effective as single agent therapy.~   "
129656|NCT01358318|"~     The purpose of this study is to determine whether ingestion of a bar containing either added~     soy protein or soy fiber or both, increases subjective and objective measures of satiety~     compared to a control bar.~   "
129657|NCT01358305|"~     Soy protein is a high quality, plant-based protein that is comparable to milk, meat and~     eggs. Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein~     (slow). This intermediate rate may allow soy protein to have an extended window of muscle~     protein synthesis that has not been monitored in previous studies. While most of the sports~     nutrition recovery products are dairy-based protein blends (high in branched-chain amino~     acids), soy protein offers additional benefits that can make an important contribution to~     these types of sports nutrition products. Soy protein contains approximately 300% more~     arginine and 30% more glutamine compared to whey protein and these two amino acids may bring~     additional benefits (immunity and hydration, respectively) to athletes. A blend of~     high-quality proteins (soy and dairy) may be the optimal sports nutrition product for~     athletes to consume following training.~   "
129658|NCT01358292|"~     Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for~     extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary~     nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee~     flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)~      Research Objectives:~      The primary research objectives are to evaluate:~      i) anterior knee pain and ii) the nail position and overall fracture alignment~      Outcome Measures:~        1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.~        2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by~          means of Patient questionnaires~        3. Knee-related adverse events~        4. Overall fracture alignment~   "
129659|NCT01358279|"~     This study is conducted to investigate the therapeutic efficacy and safety of transcranial~     direct current stimulation (tDCS) over the primary motor cortex of patients with acute~     migraine attack.~   "
129660|NCT01358266|"~     The purpose of this study is to evaluate the safety and efficacy of intravitreal injections~     of DE-109 ophthalmic solution.~   "
129661|NCT01358253|"~     The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined~     with chemotherapy in CD20+ adult acute lymphoblastic leukemia.~   "
129662|NCT01358240|"~     This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle~     in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6~     week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study~     will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for~     blinding purposes only.~   "
129663|NCT01358227|"~     The purpose of this study is to determine the side effects and best weekly dose of PR104 in~     patients with advanced solid tumors.~   "
129664|NCT01358214|"~     Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a~     TiLOOP® TAPE surgical mesh for stabilization of the urethra.~   "
129665|NCT01358201|"~     The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are~     fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and,~     consequently, the results of treatment are substantially lower. Additionally, elderly~     patients tolerate the drugs considered relatively low-key in the management of the LAL and~     suffer more toxicity. Although the LAL is much more common in patients over 60 years of age~     than in younger adults, older adults with ALL are clearly underrepresented in prospective~     controlled studies. A good portion of elderly patients are not able to tolerate the~     intensity of the standard treatment applied to children or young adults and a significant~     portion of them receive only palliative or supportive treatment. The data in the literature~     relating specifically to the elderly population are scarce and most of them have obtained a~     stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date,~     the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients~     because this protocol less aggressive than those used in high-risk ALL. However, the~     development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a~     relatively common type of LAL in the older patient, requires a differentiated treat these~     patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol~     has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a~     significant benefit in survival related to the reduction of treatment (removal of the~     L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to~     a reduction in toxicity~   "
129666|NCT01358188|"~     Gaucher disease (GD), the inherited deficiency of the lysosomal enzyme glucocerebrosidase is~     characterized with accumulation of abnormal lipid in cells of the immune system, called~     macrophages. Lipid engorged macrophages, then become activated, and are also called Gaucher~     cells. The mechanisms leading to macrophage activation is not fully known, however several~     findings in individuals with GD, such as non-specific inflammation,clinically resembling a~     rheumatic disease with an increased sedimentation rate, joint pain, and extreme fatigue, in~     addition poor wound healing, and a predisposition to diabetes may suggest an inappropriately~     functioning immune system in GD. The pathways leading to macrophage activation could be~     related to the accumulation of lipid metabolites or through the effects of other immune~     cells. In this study, immunologic profiling and functional assays will be performed in~     peripheral blood samples from patients with GD. The identification of the immunologic basis~     of GD will lead to the the development of new disease markers and different treatment~     options.~   "
129667|NCT01358175|"~     This study will assess the efficacy and safety of secukinumab in patients with active~     ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs,~     DMARDs and / or TNFα inhibitor therapy.~   "
129668|NCT01358162|"~     Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the~     safety and tolerability and pharmacokinetics.~   "
129670|NCT01358136|"~     The hypothesis of the study is that among patients that do not develop overt hypothyroidism~     after hemithyroidectomy, weight gain is a clinical manifestation of a postoperatively~     lowered set point of thyroid function - even if the thyroid function is lowered within the~     laboratory reference range. The investigators refer to this hypothesized condition as~     individual subclinical hypothyroidism.~      Thyroid hormones are major regulators of mitochondrial function and subclinical~     hypothyroidism affects mitochondrial activity. The aim of the study is to examine if a~     lowered set point of thyroid function after hemithyroidectomy can be measured in the~     mitochondrial function, the body weight and the basal oxygen consumption.~   "
129671|NCT01358123|"~     In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag)~     are found frequently but the clinical significance is unclear. vWF-Ag plays an important~     role in primary haemostasis and development of thrombotic vascular obliteration is discussed~     as a possible mechanism leading to portal hypertension. Invasive measurement of hepatic~     venous pressure gradient (HVPG) is the current gold standard for the diagnosis of portal~     hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with~     portal pressure and predict clinically significant portal hypertension (CSPH, HVPG >=10mmHg)~     and its complications.~   "
129672|NCT01358110|"~     The purpose of this study is to: 1) identify the palliative care needs of Emergency~     Department patients with advanced cancer, and determine if these needs can be rapidly~     assessed in the ED; 2) determine whether early palliative care consultation improves~     survival, quality of life and other burdensome symptoms and decreases utilization as~     compared to usual care.~   "
129673|NCT01358097|"~     The purpose of this study is to investigate the role of the immune system in the response of~     squamous cell cancers of the head and neck to treatment that includes radiation therapy.~     Current research demonstrates that several natural immune cells and molecules affect the way~     the body's immune system interacts with a cancerous growth. Some cancers may be related to~     infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of~     the immune system in head and neck cancers, especially cancers related to HPV infections,~     can provide valuable information to better understand the body's interaction with cancer~     cells.~   "
129674|NCT01358084|"~     The main objective of the trial is to document the efficacy of NGR-hTNF administered as~     maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma~   "
129675|NCT01358071|"~     The primary objective of this randomized phase II trial is to compare progression-free~     survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients~     randomized to an anthracycline alone~   "
129676|NCT01358058|"~     In this research study the investigators are looking at a type of radiation called proton~     radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area~     of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects~     that patients would normally experience with conventional radiation therapy.~      In this research study the investigators are looking to determine if proton radiation with a~     reduced field size will be as effective in controlling tumor growth as photon therapy, while~     reducing the treatment-related side effects observed in patients with brain tumors.~   "
129677|NCT01358045|"~     Basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians and the~     incidence is still increasing with 3-8% each year. Since BCCs generally occur on sun-exposed~     areas of the skin, the rice in incidence is mainly explained by the increasing exposure to~     (intermittent) ultraviolet radiation. Surgical excision is still the standard treatment for~     (micro)nodular BCCs. The costs as well as the increased workload are stressing the health~     care system even further and posing BCC an important health care problem. Since half of the~     BCCs arise primarily on the face & (bald) head and treatment by surgical excision may result~     in disfiguring scars, patients often experience a dramatic decrease of their quality of~     life. Hence, there is an urgent medical and societal need for a simple and cheap (targeted)~     treatment, preferably to be performed by the patients themselves. This treatment must be~     safe and effective. Such treatment is not available yet. BCC tumorigenesis is complex and~     must be multifactorial. Genetic alterations of multiple components of the Sonic Hedgehog~     (SHH) pathway are involved in sporadic BCC pathogenesis; inactivating mutations in Patched-1~     (PTCH1) and activating mutations of Smoothened (SMO) and Suppressor of Fused (SU(FU)). With~     this knowledge, inhibition of the SHH pathway by SMO antagonists was successfully~     administered, however treatment resulted only in partial clinical response ofBCC. Recently,~     involvement of the Wingless (Wnt) pathway has been proven to be essential in BCC tumorigenic~     response. Moreover, a recent study of our own department provides the first evidence that~     epigenetic alterations, particularly promoter hypermethylation, influence both the SHH and~     Wnt pathway (own data, not published), which can serve as therapeutic targets. Both~     non-steroidal anti-inflammatory drugs (NSAlDS) and vitamin D derivatives are able to~     directly or indirectly target the Wnt pathway. Furthermore, vitamin D3 is able to inhibit~     Smoothened (SMO) in vitro, resulting in inhibition of the SHH pathway. Although in vivo~     studies are lacking, the investigators assume that topical application of these drugs may~     inhibit BCC growth and/or may cure BCC and thus might provide very promising future~     perspectives. Calcitriol and NSAlDs ointments are both already available for other~     indications and save in use. Eventually, our approach may result in a systematic approach to~     BCC, targeting (epi)genetic changes to treat and/or prevent further tumour growth.~   "
129678|NCT01358032|"~     The main objectives of this study are:~        1. an effect evaluation of an in-home multicomponent cognitive behavioural program on~          concerns about falling and related avoidance of activity (primary outcomes), as well as~          disability, fall incidents (secondary outcomes) and several additional outcomes in~          frail community-dwelling older people,~        2. a process evaluation of the feasibility of the program, with the following main~          outcomes: population reached, performance according to protocol, exposure and~          engagement, opinion on the program of participants and facilitators, perceived benefit~          or achievement, and experienced barriers and potential solutions, and~        3. an economical evaluation on the impact of the program on healthcare utilization and~          related costs.~   "
129679|NCT01358019|"~     The primary objective of this study is to examine a recommended dose for subsequent phase~     trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients~     with advanced and/or metastatic cancer. The secondary objectives are to study the~     pharmacokinetics and antitumor effect.~   "
129680|NCT01358006|"~     The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible~     dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A~     binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male~     volunteers.~   "
129681|NCT01357993|"~     The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at~     18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
129722|NCT01357460|"~     Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might~     benefit from endoscopic implantation of intrabronchial valves.~   "
129683|NCT01357967|"~     Recently, there are increasing data about intensity dependent amplitude change (IDAP: N100~     amplitude slope) of auditory evoked Event Related Potential (ERP) components for its role on~     surrogate marker of central serotonergic activity. A high N100 amplitude slope reflects low~     serotonergic neurotransmission and vice versa. There are a couple of studies reporting~     associations of N1 amplitude slope with response to Citalopram (positive correlation) and~     Reboxetine (negative correlation) treatment in major depressive disorder patients (2,3). The~     investigator also published a case series about SSRI super-sensitivity and SSRI induced~     mania in patients with aberrantly high N100 slope (4). And serotonin transporter gene~     polymorphism was studied for its role about pathophysiology of bipolar disorder (5, 6, 7).~     Serotonin promoter gene was known to have significant relationship with N100 amplitude slope~     (8). Furthermore previous study showed that N100 amplitude slope was well correlated with~     hypomanic and hyperthymic personality (9).~      Conclusively from above results, the investigator hypothesized that if depressive patients~     show aberrant high or low N100 amplitude slope (N100 response outliers), they will not~     response well to SSRI medication. They will response better to quetiapine XR adjunctive~     therapy. In this study, the investigator will confirm it by comparing treatment effect~     between SSRI monotherapy and quetiapine XR adjunctive in aberrant N100 responder.~      Hypothesis First visit depressive patients might have monopolar or bipolar depression. If~     depressive patients show aberrantly high or low N100 amplitude slope, they will not response~     to SSRI medication.~      Patients who have aberrantly high or low N100 amplitude slope will response better to~     quetiapine XR adjunctive therapy.~   "
129684|NCT01357954|"~     The project aims to test the effectiveness and explore the possibility of performing a novel~     therapeutic approach, targeting to increase strength and coordination around the trunk,~     giving a more active and functional seating and head control in those children with cerebral~     palsy (CP) who are wheelchair users. The project will also try to determine the muscle~     physiological effect of treatment using indirect measures of strength in the spinal~     musculature.~   "
129685|NCT01357941|"~     Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of~     recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with~     prior VTE are based primarily on expert opinion and the optimal clinical management strategy~     remains unclear.~      This multicentre, prospective cohort study aims to test the following hypotheses:~        1. Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe,~          convenient and associated with an acceptably low risk of recurrent VTE in women with a~          single prior episode of VTE that was either unprovoked or associated with a minor~          transient risk factor. (Moderate risk cohort)~        2. Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with~          a single prior episode of VTE provoked by a major transient risk factor. (Low risk~          cohort)~      All study patients will receive 6 weeks of postpartum prophylaxis.~   "
129686|NCT01357928|"~     As part of a system wide reagent verification plan Haemoscope Corporation will be running a~     study to verify the reference intervals of many of the reagents. Reference intervals will be~     constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls~     for a reference interval to be constructed from at least 120 donors. Some reagents currently~     have ranges in place based on fewer donors than that stated in the guideline. This procedure~     will provide additional testing results to meet the requirements outlined in the CLSI~     guideline. Reagents that currently have no reference intervals will be tested and will~     include a minimum of 146 donors.~   "
129687|NCT01357915|"~     The purpose of this study is to evaluate the persistence of the vaccine induced immune~     responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3~     doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during~     the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection~     in naturally infected subjects who participated in the screening visit of the primary study~     108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value~     (seropositive reference group). In addition, this study will continue to assess the~     occurrence of CMV infections as well as the continued development and validation of~     read-outs in the CMV project.~      The primary vaccination phase and Year 2 follow-up were posted as a separate protocol~     posting (NCT00435396).~   "
129688|NCT01357902|"~     It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four~     eligible, healthy, Chinese male subjects will be enrolled after providing written informed~     consent. Subjects will be randomised into two treatment groups 1 day prior to the first~     dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in~     accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg~     chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed~     tablet.~      Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study~     assessments for 7 days (until Day 8). Subjects will receive their alternate randomised~     treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further~     assessment period of 7 days and will attend a follow-up visit during 8-12 days after the~     second treatment. The total observation period in this study will be 23~34 days.~      Subjects will arrive at the research unit on the evening before each lamotrigine dosing~     occasion and will remain in the unit until the 24-h post-dose evaluations have been~     completed (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects~     will return home but must return to the unit for further assessments to be made at 36, 48,~     72, 96, 120, 144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial~     blood samples (5 mL each) will be collected for the measurement of plasma lamotrigine~     concentrations at each study assessment. Safety and tolerability assessments (monitoring of~     adverse events and serious adverse events, routine laboratory determinations, vital sign~     measurements and 12-lead electrocardiogram) will be conducted throughout the study.~   "
129689|NCT01357889|"~     The first part of the study includes a single dose treatment period to evaluate the~     pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2~     drug substance compared with process 3 drug substance. The second part of the treatment~     period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety~     and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2~     drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose~     glycemia is inadequately controlled on their current regimen of diet and exercise or stable~     dose of metformin will be recruited into the study.~   "
129690|NCT01357876|"~     Metformin is a biguanide that is marketed as an oral anti-diabetic drug. Metformin treatment~     in concert with diet and exercise is the consensus first-line treatment for type 2 diabetes~     mellitus (T2DM), and therefore it will likely be an adjunct therapy for all assets in~     development by GSK for the treatment of T2DM. Metformin has potent effects in lowering~     circulating glucose concentrations, and it is believed to have additional benefits in~     improving macrovascular outcomes, fatty liver disease and polycystic ovarian syndrome. Its~     use in a significant proportion of T2DM subjects is limited by contraindications of heart~     failure and renal insufficiency or gastrointestinal side effects. The mechanisms underlying~     its glucose-lowering effect and adverse event profile of metformin are not well understood.~     Whilst activation of AMP kinase may be important for therapeutic effect, changes in incretin~     secretion and bile acid excretion have been described, but not consistently linked to its~     therapeutic effect or AE profile. The aim of this study is to recruit T2DM patients on~     prescribed metformin monotherapy to further investigate how the glucose effects are related~     to the alterations in bile acid absorption, incretin and lipid profiles by studying these~     parameters on and off the drug. This will be done in combination with frequent capillary~     blood glucose monitoring to ensure patient safety. This study will facilitate the~     development of a pharmacodynamic model that can be used by clinical teams developing~     non-absorbable NCEs such as iBAT inhibitors.~   "
129691|NCT01357863|"~     The study will be conducted as a multicenter prospective observational cohort study, trying~     to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast~     cancer patients, whose disease has progressed after trastuzumab-containing regimen,~     comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine~     immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients~     receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab~     progression (third line or greater).~   "
129692|NCT01357850|"~     This exploratory proof of concept study will be conducted in patients with stable New York~     Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is~     to test the hypothesis that GSK716155 administration will increase glucose uptake and~     utilization in the myocardium, resulting in increased myocardial efficiency and increased~     exercise capacity. A positive result, defined as either statistically significant effects on~     one or more of the efficacy endpoints or as an overall signal suggesting a clinically~     relevant effect on myocardial physiology, would provide evidence for potential progression~     into further development in a chronic heart failure population.~   "
129693|NCT01357837|"~     The purpose of the trial is to determine whether GRT6005 is effective in patients with pain~     due to osteoarthritis of the knee.~   "
129694|NCT01357824|"~     The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on~     the throat, just below the Adams apple, to occlude the esophagus, in order to prevent~     aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this~     study will be participate in the discussion of the importance of Sellick´s Maneuver.~   "
129695|NCT01357811|"~     The primary objective of this study is to determine the effect of repeat oral doses of~     eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the~     pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This~     will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects.~     The study will comprise a screening period (between Day -45 and Day -2), treatment period 1~     (Day -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day~     24 ± 1). There will be a 10-day washout between dosing of study drug in Period 1 and Period~     2. The duration of each subject's participation in the study, inclusive of the screening and~     follow-up visits, will be approximately 10 weeks.~   "
129696|NCT01357798|"~     The objective of this study is evaluated if the Botulinum Toxin Type A is superior to 0,9%~     saline in treatment of cranial Allodynia in patients with headache.~      Hypothesis~      H(0): Botulinum Toxin Type A is not superior to 0,9% saline in treatment of cranial~     Allodynia in patients with headache~      H (1): Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia~     in patients with headache~   "
129697|NCT01357785|"~     The purpose of this clinical trial is to both clarify the efficiency of autologous~     periodontal ligament (PDL) stem cells to regenerate periodontal tissue in periodontitis~     patients with deep intraosseous defects (>5 mm) and to confirm the safety of using~     autologous stem cells in clinical periodontal regenerative medicine. This is a~     single-centre, randomized, placebo-controlled study. This study has been approved by the~     ethical committees of School of Stomatology, Fourth Military Medical University. The study~     will be conducted according to the Declaration of Helsinki.~   "
129698|NCT01357772|"~     The long-lasting phase of precursors of invasive cancer, i.e. dysplasia or intraepithelial~     neoplasia (IEN), is particularly relevant among risk determinants. At present, about 15-20%~     of all breast cancers are diagnosed in a non-invasive phase. Despite their good prognosis,~     women with breast IEN (lobular and ductal intraepithelial neoplasia, LIN and DIN) have a~     10-15/1000 annual risk of invasive disease (8-10 times the same age general population), and~     thus represent an important target for chemoprevention. In the National Surgical Adjuvant~     Breast and Bowel Project (NSABP-P1 trial), tamoxifen use at 20 mg/day was associated with a~     86% reduction of invasive breast cancer in women with previous atypical ductal hyperplasia~     (ADH) (RR=0.14, 95% IC, 0.03-0.47) and with a 56% risk reduction in women with previous~     Lobular Carcinoma in situ (LCIS) (RR=0.44, 95% IC, 0.16-1.06). However, tamoxifen use in~     this setting is hampered by serious adverse events attributable to its partial estrogenic~     activity, such as increased risk of endometrial cancer and of venous thromboembolism, which~     have significantly limited its broad use in chemoprevention.~      To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.~     Recent trials from our group have shown that the dose can be reduced up to 1 mg/day with no~     loss of tamoxifen antiproliferative activity on breast cancer. By contrast, a dose of 5~     mg/day does not increase endometrial proliferation and is associated with a decrease of the~     estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding~     globulin (SHBG) and antithrombin-III, with a potential decrease of venous thromboembolic~     events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day~     attains at the breast tissue level a concentration 10 times higher than that needed to~     inhibit cell growth in vitro. The promising clinical activity of 5 mg/day of tamoxifen is~     supported by an ongoing 2x2 phase IIb trial of low-dose tamoxifen and fenretinide in~     premenopausal women, where tamoxifen lowers breast cancer events compared with placebo. The~     cytochromeP450 2D6 (CYP2D6) enzyme mediates oxidation of N-desmethyl tamoxifen to endoxifen,~     the most active metabolite of tamoxifen. The single nucleotide polymorphism (SNP) CYP2D6*4~     (1846G>A) allele accounts for 75% of CYP2D6 poor metabolizer phenotype and poor metabolizers~     showed a trend to a higher risk to develop a breast event compared to wildtype.~   "
129699|NCT01357759|"~     This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study~     in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to~     determine the safety and tolerability of MORAb-022.~   "
129700|NCT01357746|"~     This is a non-invasive study using a standard doppler echocardiographic transducer which~     records signals emanating from the lungs (TPD). These signals are caused by pulsation of~     blood vessels in the lung tissue.~      The innovations in this study are:~        1. The software processing of the reflected ultra-sound waves from the lung rendering a~          reproducible, clear and strong signal in sync with the cardiac cycle,~        2. The observation based on pilot studies that blowing hard against resistance during~          recording (something called a Valsalva maneuver), affects the lung signal weakening it~          and even obliterating it as the pressure rises.~      The investigators hypothesis is that since the signal comes from the blood vessels in the~     lung, the pressure at which the recorded signal disappears during the Valsalva maneuver~     represents the blood pressure in the lungs.~   "
129701|NCT01357733|"~     Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will~     receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed~     tomography (CT) scan at the time of initial staging. The patients will be diagnosed and~     undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.~      After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone~     (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers~     from nadir (usually 13 to 16 days after) following the administration of first cycle of~     R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT~     study will not impact patient management, except in rare case where newly developed lesion~     is found and biopsy confirmed.~      The same PET/CT system and analysis software will be used for all scans from baseline to~     surveillance for all patients enrolled in this study.~      After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with~     newly developed lesion will receive different chemotherapy regimen, while patients with~     stable disease, partial metabolic response or complete metabolic response will continue to~     receive 3 more cycles of R-CHOP.~      After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for~     response assessment. Selected patients with persistent disease or very bulky tumor volume on~     initial staging images will receive additional radiation therapy.~      The patients will be followed up every 3 months for 2 years from beginning of therapy.~     Physical examination and lab studies will be done usually every 3 months. Imaging studies~     will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted~     when different schedule is applied for surveillance.~      The end points are changes in FDG uptake measurements between the baseline and early interim~     FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response~     assessment following completion of 6 cycles of R-CHOP with or without radiation therapy~     assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid~     Tumors (PERCIST) guideline; and the 2 year disease free survival.~   "
129702|NCT01357720|"~     This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by~     Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for~     all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface~     antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and~     anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.~   "
129703|NCT01357707|"~     The project strives to discover novel genetic defects that cause monogenic epilepsy or that~     genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes~     for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral~     malformation, lissencephaly or metabolic disorders and which have a comparatively benign~     prognosis.~      The investigators hypothesize that mutations in genes coding for ion channels or genes that~     modify the action of ion channels might be causative.~      For that the investigators will perform a sequence analysis of the coding exons of a large~     set of genes in all recruited patients and verify found mutations in their parents.~   "
129704|NCT01357694|"~     The major purpose of this study is to determine whether psychotherapeutic contacts for~     surgical patients with psychological distress are an effective treatment during the~     postoperative period to improve the rate of treatment participation in subsequent~     psychosocial treatment programs.~   "
129705|NCT01357681|"~     Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative~     disease. Clinically, HD is characterized by a triad of movement disorders, cognitive~     impairments and psychiatric disturbances. These symptoms represent a tremendous burden for~     patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based~     standard therapy available.~      The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial~     effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy~     and tolerability of EGCG in HD.~      The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of~     1200 mg compared to placebo during a period of 12 months improves cognition in patients with~     HD. As primary outcome measure, the change of cognitive functions (as measured by the~     Unified Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test,~     Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to Baseline was~     defined.~      The investigators further expect a positive influence of EGCG on other clinical~     manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and~     tolerability of EGCG in HD patients.~   "
129706|NCT01357668|"~     The purpose of this study is to examine the long-term safety of Abatacept for the treatment~     of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of~     serious infections, autoimmune disorders, and malignancies.~   "
129707|NCT01357655|"~     The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)~     CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.~   "
129708|NCT01357642|"~     This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation~     Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in~     comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist~     (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.~   "
129709|NCT01357629|"~     This study examines the long term Safety Follow-up of first patients vaccinated with AD02.~   "
129710|NCT01357616|"~     The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy~     and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice~     daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic~     Solution, each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular~     hypertension who were insufficiently responsive to monotherapy.~   "
129711|NCT01357603|"~     The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard~     to its total and to its maximum serum insulin concentrations.~   "
129723|NCT01357447|"~     Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway.~     This manifestation of the disease leads to the common complaint of persistent dry cough that~     is seen in many of these patients. This study is aimed at determining whether the regular~     use of Pulmozyme will result in decreased cough and improved quality of life.~   "
129712|NCT01357590|"~     ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending~     thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a~     0.035 guidewire and positioned under fluoroscopic control. If necessary, an arterial~     conduit technique may be required to allow access to the arterial system. The soft tapered~     tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed~     to provide excellent flexibility and control through tortuous arterial anatomy.~      Each individual stent graft device is supplied sterile and pre-loaded in a single-use~     delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin~     wall woven polyester and nitinol ring stents, which are attached to the fabric with braided~     polyester sutures. The delivery system central catheter is a stainless steel braided~     co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide~     significant torque control and strength, while also maintaining superior flexibility. The~     outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless~     steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant~     coating. These materials provide very low friction force during device insertion and~     deployment together with enhanced flexibility of the delivery system. The handle components~     are moulded from thermoplastic polyurethane.~      The materials of the endoprosthesis are identical to those of the current Conformité~     Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal~     aortic aneurysm repair. The materials of the delivery system are well established in medical~     applications. The design of ThoraflexTM is based on the same principles as other clinically~     established thoracic endovascular devices. The endoprosthesis is constructed of~     self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the~     endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery~     system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal~     deployment position can be enhanced.~      The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the~     descending thoracic aorta, which is identical to other CE approved thoracic endovascular~     devices.~   "
129713|NCT01357577|"~     With this research, the investigators hope to learn if cognitive behavioral therapy (CBT)~     for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems~     with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not~     given treatment for their PTSD. It was believed that PTSD treatment would get in the way of~     their drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may~     make it harder to avoid using drugs and alcohol, so the investigators want to see if people~     can get treatment for both problems at the same time.~      One hundred-sixty Veterans from 3 VA sites will be in this study. All Veterans will be~     getting outpatient substance abuse treatment. In order to know if the PTSD treatment is~     helpful, half of the Veterans in this study will receive PTSD treatment and half will~     continue to get their usual substance abuse treatment. Who gets which treatment will be~     decided by a random process. The investigators will then compare the 2 groups to see if~     there are differences in their PTSD symptoms.~   "
129714|NCT01357564|"~     This proposed study addresses this call by testing the efficacy of a transformative~     patient-centric intervention designed to reduce the burden of NPS in Veterans with dementia~     who live at home with family caregivers. The innovative intervention, the Tailored Activity~     Program (TAP-VA), involves 8 sessions over 4 months in Veterans' homes. An occupational~     therapist conducts a systematic assessment to identify a Veteran's preserved capabilities~     and deficit areas, and previous roles, habits and interests from which to develop and~     introduce activities tailored to the Veteran's profile. Family caregivers are then trained~     to incorporate tailored activities into daily care routines. The intervention was pilot~     tested in an NIMH funded study with 60 community-living individuals with dementia. Findings~     from this pilot showed statistically significant and clinically meaningful reductions in~     NPS, specifically agitation and less time being on duty by family caregivers. Results of~     this pilot phase support moving forward with a full-scale Phase III efficacy trial. The~     investigators plan to test TAP-VA in a randomized two-group parallel design in which 160~     racially and ethnically diverse Veterans with dementia and their family caregivers (dyads)~     will be randomly assigned to receive TAP-VA or an attention control group. All dyads will be~     evaluated at baseline and 4-months (main trial endpoint), and then reassessed at 8-months to~     evaluate long-term treatment effects (baseline to 8 months), including continued activity~     use, caregiver well-being, and costs.~   "
129715|NCT01357551|"~     Obesity is the second leading cause of preventable deaths in the United States and is~     associated with a wide range of diseases. In people who are obese, weight loss improves~     blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for~     several disease processes; increases physical functioning; and enhances health-related~     quality of life. The current study evaluated a theoretically informed maintenance~     intervention. If effective, this intervention could reduce the need for future clinic visits~     to treat obesity and its many associated illnesses.~   "
129716|NCT01357538|"~     This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of~     Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.~   "
129717|NCT01357525|"~     The current study seeks to further investigate the impact of Stereotactic Body Radiation~     Therapy following pancreatic resection with a close or positive margin. The investigators~     hope to improve local control, and through the use of a shortened treatment schedule, allow~     patients to begin systemic therapy earlier.~   "
129718|NCT01357512|"~     The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging~     (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer~     based on serum prostate-specific antigen antigen (PSA) value are included. Men are~     randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound~     guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on~     MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.~   "
129719|NCT01357499|"~     The purpose of this study is to investigate if remote ischemic preconditioning by combining~     limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better~     results in preconditioning the human heart than limb ischaemia alone does.~   "
129720|NCT01357486|"~     The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in~     France and about 2 / 3 of patients, are not eligible for curative treatment at the time of~     diagnosis. The palliative management of patients with advanced and symptomatic disease is~     complex and requires treatment combining anti-tumor activity and safety in patients with~     impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the~     benefit of sorafenib in patient with altered liver function is uncertain. The aim of this~     trial is to study the interest of sorafenib in patients with HCC and impaired liver function~     compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination~     sorafenib/pravastatin or to best supportive care (usually used in these patients).~   "
129721|NCT01357473|"~     The proposal of this study is to evaluate the association between the achievement of ongoing~     pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH-~     antagonist cycles.~   "
129724|NCT01357434|"~     Rating systems are intended to guide consumer choices. This project will determine if a~     previously developed scale that evaluates the healthiness of a restaurant is correlated~     with the actual choices consumers make when they patronize the restaurants. The study will~     also assess whether a restaurant marketed as healthy (Subway) rates higher on this scale~     than another restaurant that makes no such claims (McDonald's). Finally, the investigators~     will compare the calorie purchases from these two restaurants among youths and their~     families who eat at each of the restaurants.~   "
129725|NCT01357421|"~     This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers~     participating in an endotoxin challenge.~   "
129726|NCT01357408|"~     The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL~     Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass)~     data to predict future cardiac events in heart failure (HF) patients recently discharged~     after a hospitalization for heart failure who have or plan to have a implanted loop recorder~     (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV~     function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for~     heart failure who either have a Reveal XT device in place or plan to have the ILR device~     inserted for clinical indication within 14 days of discharge from the hospitalization. HF~     patients will be followed for 6 months. Device date will be captured during normal clinic~     visits and at 6 months.~   "
129727|NCT01357395|"~     The purpose of the study is to evaluate the safety and potential benefit of combination~     amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small~     cell lung cancer (SCLC) subjects.~   "
129728|NCT01357382|"~     Current obesity prevention emphasizes caloric restriction and avoidance of high fat foods.~     The result is an approach that replaces dietary fat with carbohydrates. There has, however,~     since been an obesity epidemic with an increased prevalence of metabolic syndrome (MetS) and~     type II diabetes. Negative results from trials of low fat diets for weight loss, prevention~     of heart disease and malignancies are consistent with the inadequacy of low fat/high~     carbohydrate approach. One of the findings of trials comparing low fat, calorie reduced~     diets to ad lib carbohydrate restricted diets is that subjects randomized to a low~     carbohydrate intake lose more weight despite equivalent intake. This equates to a 200~     kcal/day greater weight loss on a carbohydrate restricted diet. Some investigators have~     speculated the metabolic advantage of carbohydrate restriction is due to increased energetic~     costs of gluconeogenesis. Alternatively, carbohydrate restriction is associated with~     increases in spontaneous physical activity.~      This protocol has three aims. First, adherence to a carbohydrate restricted diet in subjects~     with metabolic syndrome will cause an increase in spontaneous physical activity, independent~     of weight changes. Second, cardiometabolic risk factors (ApoB, TG, HDL, blood pressure, CRP)~     will show greater improvement on a carbohydrate restricted diet compared to a low-fat, high~     carbohydrate diet. Finally the investigators will interview a sub-sample of participants to~     better understand quality of life issues with respect to the dietary assignment or lifestyle~     intervention.~      The investigators will recruit 72 participants with MetS, from the Metabolic Syndrome~     Program at St. Paul's Hospital, Vancouver. Individuals will be randomized to either a~     low-carbohydrate diet or a calorie restricted, low fat diet and followed for 6 months. The~     investigators will measure body composition with bioelectrical impedance at baseline, 3 and~     6 months. The investigators will also examine cardiometabolic changes due to the standard~     lifestyle intervention compared to the carbohydrate restricted treatment. The investigators~     will examine blood pressure, triglycerides, LDL-chol, HDL-chol, C-reactive protein,~     apolipoprotein B, glucose, insulin, hemoglobin A1c and leptin at baseline, 3 and 6 months.~     The investigators will use accelerometers to assess changes in physical activity. The~     investigators will use three-way repeated-measures ANOVA, with changes in body weight and~     insulin levels as covariates in the model with time as the repeated factor for statistical~     analyses.~   "
129729|NCT01357369|"~     This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron)~     given routinely to pregnant women who are planning to deliver via cesarean section. The~     investigators will evaluate the metabolism of both drugs by the pregnant woman, the~     placental transfer over time, and the subsequent metabolism of the transferred drug in the~     neonate.~   "
129730|NCT01357356|"~     The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray~     formulations in patients with nocturia for a total duration of 14 weeks.~   "
129731|NCT01357343|"~     This study is being conducted to compare the effectiveness of integrated chiropractic and~     acupuncture care for the management of low back pain.~   "
129732|NCT01357330|"~     Primary Objective:~      - To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s)~     (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or~     metastatic solid tumors.~      Secondary Objective:~        -  To characterize the safety and tolerability of SAR245408 and MSC1936369B combination~          therapy administered orally to adult patients with locally advanced or metastatic solid~          tumors~        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in~          combination~        -  To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by~          assessing target and pathway inhibition~   "
129733|NCT01357317|"~     Objective: To examine the effects of three commonly applied treatments of disordered~     phosphorus homeostasis on biochemical markers and vascular characteristics in patients with~     moderate and advanced non-dialysis dependent chronic kidney disease.~   "
129734|NCT01357304|"~     The purpose of this study is to determine the effects of group treatment including physical~     activity referral (PAR) on level of physical activity and quality of life in patients~     diagnosed with type 2 diabetes and/or hypertension in a primary health care setting~   "
129735|NCT01357291|"~     A a multi-site trial to measure the efficacy of the Recidivism Reduction Program, a prison~     based, twenty-one module reentry program operated by the New Mexico Department of~     Corrections.~   "
129736|NCT01357278|"~     The main objective of this study is to target risk factors for falling, such as improved~     quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of~     osteoporotic fractures. Furthermore, to improve quality of life for patients with~     osteoporosis through an active rehabilitation program.~      Sub-goals:~        1. To assess the effect of active rehabilitation on risk factors for osteoporotic~          fractures (muscle strength, bone mineral density, balance and frequency of falling) in~          women with low bone mineral density (BMD)(t-score<1.5) and radius fracture?~        2. To assess how active rehabilitation affect the quality of life of women with low bone~          mineral density(BMD) (t-score<1.5) and radius fracture?~   "
129737|NCT01357265|"~     This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when~     administered to adult and elderly subjects.~   "
129738|NCT01357252|"~     The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd~     as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled~     with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at~     supporting the regulatory approval in China of vildagliptin as combination therapy with~     sulfonylureas in the treatment of type 2 diabetes.~   "
129740|NCT01357226|"~     Context: Use of automated blood pressure (BP) measurement devices in the office setting is~     increasingly recognized as superior to manual BP measurement. Current recommendations are to~     have the patient alone in a quiet room, with no interactions with health care professionals~     during the readings. However, this may not be practical in primary care offices where the~     exam rooms are constantly being used.~      Objective: To compare measurements with an automated BP device in private examination rooms~     with measurements in non-private areas of a primary care office.~      Design: Randomized controlled trial with cross-over.~      Setting: Community based primary care office participating in the NorTReN Practice Based~     Research Network in Toronto, Ontario.~      Participants: Fifty consecutive consenting patients over the age of 18 having their BP~     checked as part of their routine care.~      Intervention: Patients will be randomly allocated to either automated BP measurement in an~     exam room, or in a non-private area of the clinic. After being tested in the first location~     they will subsequently be tested in the second location with the same device.~      Main outcome measure: The primary outcome measure is a comparison between the mean systolic~     values of the automated BP measurements in the two office areas. The investigators will use~     the t-test for paired samples. The secondary outcome is a comparison of systolic values for~     patients with previously documented hypertension. The investigators define a clinically~     meaningful result as a difference of 5 mmHg or more in systolic BP.~      Conclusion: New technology is more readily adopted if barriers to use are minimized. If the~     investigators find no differences in BP readings between office locations, physicians will~     then have the convenience of an additional office area to implement the automated BP~     measurement device.~   "
129741|NCT01357213|"~     This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study~     of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will~     be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the~     24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum~     monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in~     which they will receive a single intravenous infusion of active drug or placebo. Placebo~     will be normal saline. Volunteers will be followed for safety for up to 120 days after~     infusion depending on dose cohort.~   "
129742|NCT01357200|"~     This study will assess enteral feeding in an obese critically ill population with a higher~     protein whey based peptide formula.~   "
129743|NCT01357187|"~     The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the~     reduction of the tenacity and frequency of soft tissue adhesions during the removal of~     segmental posterior lumbar instrumentation.~   "
129744|NCT01357174|"~     This study will collect demographic and safety information on the use of ROTATEQ™ in the~     Philippines.~   "
129745|NCT01357161|"~     This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel +~     carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with~     the P53 mutation. In Part 1, a small group of participants will receive MK-1775 along with~     paclitaxel and carboplatin to find the maximum tolerable MK-1775 dose for this combination.~     Pharmacokinetics will also be assessed during this period. In Part 2, participants will be~     randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo +~     paclitaxel + carboplatin.~   "
129746|NCT01357148|"~     The primary objective of this study is to obtain safety information on the use of~     sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists,~     diabetologists, internists, and general practitioners.~   "
129747|NCT01357135|"~     This is an observational study to compare the effectiveness of dual therapy of Type II~     diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine~     clinical practice in France.~   "
129748|NCT01357122|"~     This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer~     Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current~     standard forceps insertion DSAEK technique. The goal of this study is to examine the damage~     to the corneal endothelium resulting from the use of the NCI device in comparison to the use~     of our standard surgical DSAEK technique over time.~   "
129749|NCT01357109|"~     The purpose of the study is to investigate if oral treatment with bosentan improves~     endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.~   "
129750|NCT01357096|"~     The hypothesis of this project is to examine whether the integrated health care program as~     the intervention group can reduce the recurrence and mortality of coronary artery-related~     diseases than the traditional one as the comparison group.~   "
129751|NCT01357083|"~     One of the main points in the biological trends is, the circadian rhythm and disturbance in~     this cycle, which cause mood disorders and irregularity in this bio clock, to get~     depression. The pineal gland with the precise regulation of circadian rhythm of melatonin~     regulates the brain haemostasis. The abnormal function of this gland gives rise to~     psychiatric disorders.~      In the period of youth and early of middle-age cause biochemical changes and disturbance in~     biorhythm including melatonin secretion.~      This process can change the peak of melatonin phase. In addition, a decrease in the level of~     serum melatonin, can change the function of immune system of depressed patients. This~     function facilitates the process of cancerous cell formation and tumor growth.~      With respect to the conflicting results and that the positive and negative roles of~     melatonin in the creation of depression is unknown, the aim of this study was to compare the~     morning and nocturnal serum melatonin rhythm levels in the patients with Major Depressive~     Disorder. The second purpose was to measure the morning and nocturnal serum melatonin levels~     in the depressed and healthy men and women.~   "
129752|NCT01357070|"~     Atherosclerosis is the disease process that leads to hardening of the arteries which causes~     them to become narrowed. This occurs because fat is first deposited on the inside walls of~     the arteries, then becomes hardened by fibrous tissue and calcium deposition forming a~     semi-hardened accumulation of material known as plaque. As this plaque grows, it narrows the~     channel within the artery and causes a reduction in blood and oxygen supply to the affected~     organ - such as the heart and brain. The investigators now understand that this process is~     caused by inflammation and activation of the immune cells over a period of time. It has been~     proposed that targeting these immune cells and reducing the levels of immune activation can~     protect against cardiovascular diseases.~      Previously it has been observed that consumption of fruit and vegetables rich in~     anti-oxidants can confer a protective effect against cardiovascular diseases. The use of~     anti-oxidants experimentally has shown protective benefits against activation. The~     investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective~     means of providing vascular protection.~      Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli,~     brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by~     inducing a number of anti-oxidant molecules. Targeted studies on the consumption of broccoli~     and related vegetables have been shown to be associated with reduced risk of coronary artery~     disease.~      In the present study the investigators want to test whether the consumption of a broccoli~     smoothie containing sulforaphane can protect white blood cells from becoming activated in~     the presence of an experimental stress and how long this protective effect lasts for. To do~     this, the investigators will be analysing inflammatory changes in blood samples taken at~     different times during the study.~   "
129872|NCT01355497|"~     The purpose of this study is to determine if the investigational drug GTx-024 can help~     patients with non small cell lung cancer increase physical function and maintain or gain~     muscle.~   "
129756|NCT01357018|"~     Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as~     rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it~     can not only affect patient's working ability but also produce indirect cost in patient's~     family. Quality of life will also be affected. Health-related quality of life issues are~     assuming increasing importance in chronic rheumatic diseases. However, studies on quality of~     life in rheumatic patients are limited. Factors related to quality of life are not clear.~     Application of quality of life measurement for improving clinical care of RA and AS patients~     is still difficult. The objective of this study was to evaluation the validity of EQ-5D life~     quality measurement in chronic arthritis patients in Taiwan. Factors associated with life~     quality will be addressed. This will also provide useful information for public health~     policy making.~   "
129757|NCT01357005|"~     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications~     that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics~     Initiative and to apply genomic methods to further our understanding of the molecular~     etiology of the disorder. The overarching aims of this proposal are to quickly and~     cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to~     discover causal variants for the disorder in the first family-based genome-wide association~     study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this~     kind of GWAS study as it is a very expensive study, including collecting large family~     samples and genome-wide SNP scanning. The investigators, thus, collaborate with Professor~     Ming T, Tsuang and his intended subcontracted researchers to apply for this project. The~     investigators, the research team in Taiwan, will collect 3800 trio families (11400 subjects)~     of schizophrenia.~      The investigators will meet the overarching goals of this project by accomplishing several~     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese~     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending~     all clinical data and biomaterials to the appropriate repositories; 3) Assess the~     association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms~     (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes~     such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to~     schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for~     gene-environment interactions, such as the well-established effect of season of birth.~   "
129758|NCT01356992|"~     This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®,~     Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main~     justification is the search for scientific evidence to prove the Versa® effectiveness for~     this new therapeutic indication, since it is a product with potential for reducing costs,~     with effectiveness and safety comparable to the reference drug.~   "
129759|NCT01356979|"~     Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method~     in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for~     malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as~     fibrinous pleuritis make confusion in clinicians. Whether these patients are firmly followed~     or not ? The investigators do not know the answer of this question.~      In this study the investigators aimed to investigate the outcome of the patients who are~     diagnosed as fibrinous pleuritis on MT biopsies.~   "
129760|NCT01356966|"~     Patients with chronic kidney disease have profound exercise intolerance which contributes to~     an increased risk of cardiovascular disease. The investigators have found that chronic~     kidney disease patients have an exaggerated increase in blood pressure during certain forms~     of exercise that could certainly contribute to exercise dysfunction as well as~     cardiovascular risk. The investigators will test the mechanisms underlying this exaggerated~     blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin~     (BH4) with folic acid on both exercise dysfunction and cardiovascular risk factors in~     chronic kidney disease. The investigators will test whether short-term treatment with~     tetrahydrobiopterin (BH4), a cofactor for nitric oxide, together with folic acid improves~     inflammation, vascular health, and adrenaline levels, both at rest and during exercise in~     chronic kidney disease.~   "
129761|NCT01356953|"~     The purpose of this study is to determine if a single session of aerobic exercise~     effectively controls the blood pressure (BP) of individuals with type 2 diabetes mellitus~     (T2DM) over the 24h of post-exercise period, and the effects of intensity of aerobic~     exercise on these BP responses.~   "
129762|NCT01356940|"~     A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect~     on ambulatory activity in people with multiple sclerosis~   "
129763|NCT01356927|"~     Contraception after abortion is an important public health issue, as women who have an~     abortion are at high risk for additional unintended pregnancy. In the context of first~     trimester medical abortion, the standard of care is to administer long-acting reversible~     contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone~     acetate (DMPA), at a follow-up appointment after the abortion.~      The investigators plan to conduct a prospective pilot study to evaluate the satisfaction of~     subjects who have either the contraceptive implant or DMPA given on the first day of medical~     abortion, as opposed to at a follow-up appointment. The investigators will also assess the~     continuation of DMPA and Implanon at 3, 6, 9, and 12 months after the initial date of~     administration. In addition, the investigators will assess the total days of bleeding after~     the abortion, follow-up rate for evaluation of completion of medical abortion, and efficacy~     of medical abortion.~      A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA.~     They will be asked to fill out questionnaires during the course of the study, and will be~     followed for one year. The study duration including data analysis will be two years.~   "
129764|NCT01356914|"~     The purpose of the study is to determine whether treatment with BMS-914392 is safe, well~     tolerated and associated with a reduction of atrial fibrillation burden in patients with~     paroxysmal atrial fibrillation and permanent pacemaker.~   "
129765|NCT01356901|"~     The purpose of this observational study is to measure the real-life persistence, adherence~     and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral~     infection.~   "
129766|NCT01356888|"~     The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with~     the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss~     in a non-inferiority study in de novo coronary lesions at 9 months.~   "
129767|NCT01356875|"~     Transfusional dependence has been associated closely and independently with low survival in~     patients with myelodysplastic syndrome (MDS), especially in patients at low risk according~     to IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to~     treatment with 5-azacytidine has lower cost and possibly as effective with fewer side~     effects. The objective of this phase II study is to determine the effectiveness of~     combination therapy with hydralazine + Ac. Valproic compared with best supportive care. The~     investigators will select 42 patients per group, and after 14 weeks of treatment the~     investigators will study in both groups the hematological response (transfusion-dependent,~     hemoglobin, cytogenetics and morphology) and treatment safety (adverse reactions and vital~     signs) to 1 year after starting treatment. The concentration of hemoglobin, the number of~     transfusions, platelets, neutrophils and other continuous variables in both groups will be~     compared by Student t or Mann-Whitney, as appropriate. For comparison of cytogenetic and~     morphological response and other categorical variables between groups Chi square will be~     used. And within each group the investigators will compare each of these variables before~     and after treatment by t-test for paired data or Wilcoxon test.~   "
129768|NCT01356862|"~     The principal morbidity following axillary node dissection within the scope of breast cancer~     surgery is the post-operative development of lymphocele. According to the literature,~     incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is~     inserted or a compression dressing applied and the time at which the drain is removed… In~     our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70~     patients between November 2008 and February 2009]~      Encouraging results in terms of reducing postoperative lymphoceles as well as drainage~     duration and volume using Octreotide have been recorded in two recent studies. A new~     molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog~     possessing strong affinity for several somatostatin receptors (30 to 40 times greater for~     sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)~      The purpose of this trial is to assess the efficacy of a pre-surgical injection of~     pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following~     axillary node dissection.~      The secondary objectives are to assess the efficacy of prolonged release pasireotide on the~     duration of postoperative drainage, the daily drainage volume, the total drainage volume,~     the number of repeated lymphocele aspirations and the volume, the total volume of lymph~     aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and~     the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of~     prolonged release pasireotide.~      The primary objective of this study is to assess the efficacy of a preoperative prolonged~     release pasireotide injection in the reduction in the incidence of symptomatic,~     postoperative axillary lymphoceles following mastectomy-axillary node dissection.~   "
129769|NCT01356849|"~     Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective~     of the study is to evaluate the efficacy and safety of once daily administration of~     atrasentan tablets (low dose and high dose) compared to placebo in reducing residual~     albuminuria in Type 2 diabetic patients with nephropathy who are treated with the maximum~     tolerated labeled dose of a Renin Angiotensin System (RAS) inhibitor. If the patient is~     already receiving a maximum tolerated labeled daily dose of RAS inhibitor and a diuretic,~     he/she will complete 4 weeks of the Run-in Period on a dose that has not been adjusted. If~     the patient is currently not receiving a maximum labeled daily dose of a RAS inhibitor then~     the dose will be titrated up to the maximum tolerated labeled dose over the course of 4 to 8~     weeks during the Run-in Period. It is expected that subjects not receiving a diuretic will~     have a diuretic added or titrated during this period to maximize RAS inhibition. Following~     titration to the maximum tolerated labeled dose, the patient will complete an additional 4~     weeks of Run-In Period on an unchanged doses of RAS inhibitor and diuretics, unless~     medically contraindicated. The randomization will be stratified based on country where~     subjects are enrolled into the study, and the Week -1 Urinary Albumin to Creatinine Ratio~     (UACR) levels (< or = 1000 mg/g [113 mg/mmol], or > 1000 mg/g [113 mg/mmol]). Within each~     stratum, subjects will be randomly assigned in a 1:2:2 ratio to one of the following blinded~     treatment groups: Group A - Placebo once daily (QD) Group B - low dose atrasentan QD Group C~     - high dose atrasentan QD After the 12 weeks of study drug treatment, subjects will be~     followed up to 30 days.~   "
129770|NCT01356836|"~     Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia.~     Collateralization helps to restore blood flow and as a result salvages myocardium in~     severely ischemic myocardial regions. Thus, good collateral development in patients with~     severe coronary artery disease (CAD) improves ventricular function and prognosis (1-3).~      However, coronary collateral development is different among patients even with similar~     degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and~     duration of myocardial ischemic symptoms (5) have been reported to effect coronary~     collateral development. At the cellular level, inflammatory cells, especially monocytes have~     an important role in collateralization. In a series of experimental studies with animals, it~     has been shown that monocytes are important elements for development of collateral vessels~     (6-7). In a recent study, it has been demonstrated that increased circulating monocyte count~     is related to good collateral development in patients with stable coronary artery disease~     (8).~      Monocytes in human blood are heterogeneous and can be classified into two subsets according~     to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes~     characterized by high level expression of the CD14 cell surface receptor but no expression~     of CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16~     receptor with either high or low level expression of the CD14 receptor. These subsets differ~     in function and response to several cytokines.~      Our aim in this study was to find out any possible relationship between the levels of~     circulating monocyte subsets and coronary collateral development.~   "
129771|NCT01356823|"~     This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine~     expressed in E. coli.~      The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce~     higher antibody and at the same time caused less adverse events.~      The secondary purpose of this study is to to evaluate the safety and immunopersistence of~     the study vaccine.~   "
129772|NCT01356810|"~     Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course~     which is presented in 15 to 20% of patients admitted to general wards. It is a potentially~     life - threatening complication which can be prevented. It is the objective of this~     randomized controlled trial to evaluate whether a multicomponent environmental intervention~     could reduce the incidence of delirium in a general medical ward.~   "
129773|NCT01356797|"~     Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia~     technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been~     validated for this surgery. Both selective techniques are specially indicated for ambulatory~     surgery because of PACU fast track, low discharge home time and high patient satisfaction.~     This study compares both spinal techniques for knee arthroscopy surgery.~   "
129775|NCT01356771|"~     The investigators are conducting a study to provide evidence about the comparative~     effectiveness of mailed, tailored intervention materials on cancer prevention behavioral~     outcomes. The investigators will send out three (3) tailored mailings for participants who~     are assigned to the intervention group. Second, during the eligibility screening, the~     investigators will be assessing the relative yield and functioning of two risk assessment~     tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.~   "
129776|NCT01356758|"~     Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3%~     in the caucasian population of Northern Europe and the US. Similarly to other inflammatory~     diseases there is now substantial and accumulating evidence that psoriasis has a systemic~     inflammatory component.~      It is known that patients suffering from psoriasis have increased prevalence of traditional~     cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and~     diabetes mellitus. This would logically explain an increased rate of cardiovascular events,~     but even when adjusting for theses risk factors, psoriasis carry an independent risk for~     developing cardiovascular disease.~      Recent large epidemiological studies have shown a strong correlation between psoriasis and~     myocardial infarction.~      Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the~     disease has not been associated with cardiovascular disease.~      In conclusion, convincing and increasing evidence is supporting that psoriasis induce~     accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular,~     this is seen in young patients with early disease onset.~      Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A~     number of these cytokines are suggested to be atherogenic. In contrast, another chronic~     inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived~     cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest~     to compare the presence of cardiovascular disease in these two inflammatory skin diseases.~      Hypothesis: That the risk of developing cardiovascular disease and especially coronary~     artery disease is increased in psoriasis patients and that this process can be influenced by~     treatment of psoriasis with biological treatment.~   "
129777|NCT01356745|"~     Less than 10% of patients with a traumatic pain have been managed by a physician before to~     be admitted in an emergency service. 50 % of those patients have been carried by paramedics.~     Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies~     have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of~     premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.~   "
129778|NCT01356732|"~     Mechanically ventilated patients experiencing pain are frequent in intensive care units~     (ICU) however their treatment remains unclear. This prospective pharmacodynamic study~     relates to the analgesia of procedural pains. The primary objective was to determine the 90%~     effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a~     Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically~     ventilated patients.~      Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation,~     reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were~     included.~      During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of~     sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new~     LD until BPS was at 3 or 4.~   "
129779|NCT01356719|"~     Tracheostomies are artificial airway devices inserted into the neck. They can become~     displaced and lead to patient harm. Other than external visual inspection, there is no~     currently described system for describing the position of a tracheostomy tube within the~     airway. The investigators propose to undertake endoscopic inspection of the tracheostomy~     tube with a small fibre-optic camera from above and also through the tube to visualise its~     position within the airway. The investigators will take anonymised paired images and then~     score these using 6 different scoring systems. The investigators will determine which~     scoring system provides the simplest and most reproducible scores between 6 blinded~     assessors. A clinically useful scoring system could be used in future to predict problems~     with tracheostomy positioning.~   "
129780|NCT01356706|"~     Only few reports exist on long-term survival after minimally invasive liver surgery (MILS~     for colorectal liver metastases. No data are available assessing prognostic factors in the~     era of current modern treatment strategies. The aim of the current study is to analyze the~     long-term oncologic outcome after MILS for metastases from colorectal cancer and determine~     prognostic indicators.~   "
129781|NCT01356693|"~     Cough is the most bothersome symptom for patients with the common cold.~      The objective of the study is to compare the phytotherapic Bromelin, a compound~     preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas~     comosus) with placebo in reducing cough episodes in patients with the common cold.~   "
129782|NCT01356680|"~     This study is designed to test the non-inferiority of the experimental arm compared to the~     standard arm in terms of progression free survival (PFS).~   "
129783|NCT01356667|"~     Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is an R-21 NIH/NCCAM-funded~     study aimed to complete the development and pilot a new substance abuse treatment protocol~     utilizing drumming for American Indians/Alaska Natives with substance use disorders. The~     study includes activities to complete the protocol, followed by a randomized-controlled~     clinical trial.~   "
129784|NCT01356654|"~     This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in~     the recovery of postural control in stroke rehabilitation.~   "
129785|NCT01356641|"~     Appendectomy for acute appendicitis has recently been questioned as being the only correct~     treatment for appendicitis. Appendectomy has been reported to have significant early and~     late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better~     quality of life and lower costs have been associated with antibiotic treatment alone. Five~     clinical trials in selected patients (males, older than 18 years) comparing appendectomy and~     antibiotic treatment alone as primary mode of treatment found that antibiotic treatment~     alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the~     efficacy of antibiotic treatment alone in children with proven acute appendicitis however is~     lacking. We propose a prospective cohort study to answer the following questions:~   "
129786|NCT01356628|"~     This is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced~     Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver~     tumor. PD-0332991 is a compound that stops the tumor cell from entering the Synthesis phase~     of the cell cycle, therefore stopping DNA multiplication and decreased tumor cell copying.~   "
129787|NCT01356615|"~     Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as~     anticoagulation during hemodialysis (HD) therapy. In this study the investigators have~     compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.~   "
129788|NCT01356602|"~     This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison~     to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent~     flares of acute gouty arthritis.~   "
129791|NCT01356563|"~     The investigators propose that pharmacist interventions would reduce the amount of~     unresolved medication-related problems in hemodialysis patients.~      Condition:Hemodialysis patients~      Intervention:Behavioral,Pharmacist intervention~      Study Design:Randomized Allocation~      Control: Active Control~      Endpoint Classification: Efficacy Study~      Intervention Model: Parallel Assignment~      Masking: Double Blind (Caregiver, Outcomes Assessor)~      Primary Purpose: Treatment~   "
129792|NCT01356550|"~     This open-label, single-dose, parallel group study will assess the pharmacokinetics and~     safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic~     hepatic impairment. Patients and healthy volunteers will receive a single oral dose of~     RO4917838.~   "
129793|NCT01356537|"~     The purpose of this study is to proof increasing patient satisfaction and preservation of~     quality of life in patients with Gaucher's Disease receiving their enzyme replacement~     therapy with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the~     infusions at the clinic or at doctor's practice.~   "
129794|NCT01356524|"~     In Assisted Reproductive Techniques (ART) there is a need for luteal support using~     progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of~     administration and dose has not yet been determined.~      The aim of the study is to investigate whether high levels of mid-luteal serum progesterone~     are related to higher pregnancy rates in ART cycles. We also plan to investigate whether~     using higher doses of vaginal progesterone results in higher pregnancy rates.~   "
129795|NCT01356511|"~     The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known~     hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone~     compared to conventional dose prednisone for the first-line treatment of adults with primary~     immune thrombocytopenia(ITP).~   "
129796|NCT01356498|"~     This is an open-label extension phase of two double-blind, placebo-controled Phase 3~     protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic~     gout. The purpose of this study is to provide a continuation of treatment to subjects~     completing the double-blind studies and obtain long-term safety and efficacy data.~   "
129797|NCT01356485|"~     Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells~     are discoid and can deform and move through small blood vessels to carry oxygen to all parts~     of the body. In sickle cell disease, as red blood cells circulate and oxygen is released in~     the circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When~     this occurs, the red blood cells can become sticky and elongated. These sickled red blood~     cells are less flexible and will obstruct small blood vessels and block normal red blood~     cells from traveling through the circulatory system, which limits oxygen delivery to tissues~     and organs. This is known as a sickle crisis.~      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,~     heart attack or even death. By lowering the level of oxygen pressure at which sickling~     occurs and opening the vasculature and rapidly delivering oxygen directly to ischemic~     tissues, the addition of MP4CO to existing treatment protocols may alleviate pain associated~     with a sickle cell crisis, abort a crisis and/or potentially reduce the duration of a~     crisis. This could mean less time in the hospital and an improved quality of life for~     patients with sickle cell anemia.~   "
129798|NCT01356472|"~     As previous studies showed that the synergy between linezolid and carbapenem in vitro and in~     vivo (animal studies), our study is aim to investigate the activity of linezolid, alone and~     in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in~     ventilator-associated pneumonia (VAP) patients.~   "
129799|NCT01356459|"~     The study is designed as a randomised controlled trial of trauma patients admitted to the~     Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the~     Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly~     allocated to either the control group that will receive usual pressure ulcer prevention~     strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum~     dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in~     the ED.~      Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate~     of sacral and heel pressure ulcer development than patients receiving standard care.~   "
129800|NCT01356446|"~     The study investigates the impact of the implementation of a surgical checklist on the~     mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical~     procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is~     performed in a single tertiary care center. The study is an open trial before and after~     intervention (implementation of the checklist safe surgery saves lifes).~   "
129801|NCT01356433|"~     Subclinical inflammation is a common phenomenon in patients receiving maintenance~     hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to~     metabolic acidosis, volume overload, and / or non-sterile dialysate.~      As important antioxidants, vitamin C was prominently consumed by oxidative stress and~     inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C~     level.~      It was documented that inflammation was associated with increased risk of cardiovascular~     morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin~     C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had~     anti-inflammation effect on behalf of its electron receiving ability, the investigators made~     a hypothesis that vitamin C supplementation can reduce inflammation status in patients on~     maintenance dialysis~   "
129802|NCT01356420|"~     The purpose of this study is to learn about Smith-Lemli-Opitz Syndrome (SLOS). SLOS is an~     inherited condition that is caused by the body not making an enzyme as it should. The body~     needs the enzyme to help make cholesterol. SLOS can cause many health problems including~     slow growth and development, eating disorders, sleep disorders, behavior disorders, and eye~     diseases. Severe SLOS leads to birth defects and mental retardation and in many cases early~     death. The investigators plan to measure cholesterol and other sterol levels, perform~     clinical observations, whole body testing and imaging (brain MRIs), to learn more about the~     disease and its progression, differences in the clinical features among individuals with~     SLOS, and look at the effect of cholesterol supplementation in this condition.~      The study is an interventional study to characterize disease progression and correlations~     between clinical, biochemical and physiological features of the disease. The main hypothesis~     is that dietary cholesterol supplementation does not improve features of SLOS related to the~     brain (e.g. IQ, behavior).~   "
129804|NCT01356394|"~     Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD)~     such as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose~     metabolism, and insulin resistance. A number of associated conditions are included in the MS~     spectrum such as abdominal obesity, systemic inflammatory activation, endothelial~     dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome,~     and microalbuminuria. As a consequence, the diagnosis of MS identifies patients who are at~     increased risk for type 2 diabetes mellitus and CVD. In the last few years, the potential~     for MS to trigger renal damage and accelerate the progression of pre-existing nephropathy~     has become a focus of research. Some studies have suggested that MS can influence the~     development of CKD, although the underlying mechanisms are not well understood. In this~     study, the investigators hypothesized that modifying a key component of the MS, namely~     obesity, could attenuate renal damage. The investigators examined the impact of weight loss~     on creatinine clearance and urinary albumin excretion in non-diabetic obese patients with~     MS.~   "
129805|NCT01356381|"~     The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to~     placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with~     metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic~     euglycemic clamp.~   "
129806|NCT01356368|"~     The study aims at piloting the concept of customization of chemotherapy based on molecular~     markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤~     2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or~     compare individual regimen but rather it will test the approach of customization concept as~     a whole.~      The results of this pilot study will help in designing more definitive trials in our patient~     population.~   "
129807|NCT01356355|"~     The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation~     ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent~     discomfort.~   "
129808|NCT01356342|"~     This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects~     aged between 6 months old to 18 years old. All participants will be divided into three age~     cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL~     vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2~     doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years~     will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the~     time of vaccination, solicited local and systemic reactions within 7 days after each~     vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from~     blood samples will be collected from each subject immediately prior to, and 4 weeks after~     each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO~     haemaglutination inhibition reference technique. The analysis will be observer-blinded. All~     participants will be followed, either by clinical visit or by telephone contact, for 6~     months after the first vaccination for safety reasons.~   "
129809|NCT01356329|"~     Prophylactic treatment will start from surgery until the patients are discharged from the~     hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The~     first visit will be 2 weeks from discharge & the second visit will be 3 months after~     surgery. In each visit patient will be evaluated for any evidence of thrombo-embolic events~     clinically & radiologically if needed ( spiral CT, V/Q scan & lower limp Doppler ). Any side~     effect or adverse reaction will be reported & it will be evaluated if it is related to the~     drug used or not.~   "
129810|NCT01356316|"~     Each potential subject will be screened before the start of the study to determine their~     eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will~     be taken from each eligible subject, for baseline titration of circulating anti-HA~     antibodies. Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by~     intramuscular injection into the upper arm. Subjects will be asked to stay at the site for~     30 minutes post-vaccination to observe for immediate reaction. Subjects will be monitored~     for adverse events during the study. At three weeks (±3 days) after the vaccination,~     subjects will be asked to return to the site for final collection of blood samples.~   "
129811|NCT01356303|"~     This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients~     with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical~     City, Riyadh.~      Sub-sites will be open for patient accrual in selected centers in the Kingdom.~   "
129812|NCT01356290|"~     Patients with relapsed medulloblastoma have a very poor prognosis whether treated with~     conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or~     combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment~     option in solid malignancies. The frequent, metronomic schedule targets both proliferating~     tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators~     will evaluate the use of biweekly intravenous bevacizumab in combination with five oral~     drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral~     etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide~     and liposomal cytarabine. The aim of the study is to extend therapy options for children~     with recurrent or progressive medulloblastoma, for whom no known curative therapy exists, by~     prolonging survival while maintaining good quality of life. The primary objective of the~     MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these~     heavily pretreated children and young adults. Additionally, progression-free survival (PFS),~     overall survival (OS), as well as feasibility and toxicity will be examined.~   "
129813|NCT01356277|"~     The broad aim of the proposed study is to improve medication adherence in adolescent kidney~     transplant recipients. The investigators hypothesize that a multi-component intervention~     will improve medication adherence in the adolescent kidney transplant population. The~     specific aims are to determine, in a randomized clinical trial, the efficacy of a~     structured, multi-component intervention in improving adherence to anti-rejection~     medications and graft outcomes, and to identify characteristics of healthcare systems that~     are independently associated with adherence.~   "
129873|NCT01355484|"~     The purpose of this study is to determine if the investigational drug GTx-024 can help~     subjects with non-small cell lung cancer increase physical function and maintain or gain~     muscle, also called lean body mass.~   "
129814|NCT01356264|"~     Despite advances in surgical care, the incidence of postoperative complications and~     prolonged recovery following colorectal surgery remains high. Efforts to improve the~     recovery process have primarily focused on the intraoperative (eg, minimally invasive~     surgery, afferent neural blockade) and post-operative periods (eg, fast track early~     nutrition and mobilization. The pre-operative period may in fact be a better time to~     intervene in the factors that contribute to recovery. The process of enhancing functional~     capacity of the individual in anticipation of an upcoming stressor has been termed~     prehabilitation. Based on the notion that preoperative exercise would have an impact on~     recovery of functional capacity after colorectal surgery, our group recently conducted a~     randomized controlled trial. Subgroup analysis identified that patients whose functional~     exercise capacity improved preoperatively, regardless of exercise technique, recovered well~     in the postoperative period. However, one-third of patients deteriorated preoperatively~     despite the exercise regimen, and these patients were also at greater risk for prolonged~     recovery after surgery. These results suggested that exercise alone is not sufficient to~     attenuate the stress response in all patients. In the present trial, the impact of a~     multimodal prehabilitation intervention composed of exercise, nutritional supplement and~     psychological well-being begun in the preoperative period will be compared to one begun in~     the postoperative period.~   "
129815|NCT01356251|"~     The aim of this study is to learn about how mesothelioma affects patients' emotional and~     physical well-being. Also, the investigators would like to learn more about what patients~     need and how they deal with this illness. This information can help us find ways to lessen~     physical and emotional strains. Part of the study tests an alternate way of giving emotional~     support through the Internet. By providing support online, patients can participate in the~     comfort of their home.~   "
129816|NCT01356238|"~     Quality-controlled commercial media have been used in many in-vitro fertilization (IVF)~     laboratories. However, commercial media are costly and difficult to compare directly because~     their exact compositions are not clearly indicated. Although commercially available media~     have commonly been used in most IVF programs worldwide, there are several advantages to the~     use of in-house synthetic sequential media at IVF laboratories. First, the results of~     quality control should be reliable due to a stringent protocol setting-up. Second, any~     direct supplementations or deletions of specific components are feasible to obtain good~     quality embryos and high pregnancy rates since those components can be defined. Finally,~     dependence on commercially available media diminishes so that the laboratory can more easily~     accommodate unexpected situations or problems, such as a sudden increase in IVF patients.~     Therefore, the present study was conducted to compare the efficacy of in-house MRC media in~     the human IVF-embryo transfer (ET) program to that of commercially available media.~   "
129817|NCT01356225|"~     The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN)~     administration of ketorolac after dental impaction surgery.~   "
129818|NCT01356212|"~     This was a randomised three-way crossover design study. The study consisted of three study~     periods each separated by a minimum 44 hour washout period. During the course of each study~     period, scintigraphic images were acquired at planned intervals after dosing. Subjects were~     able to leave the clinical unit after the completion of study specific procedures at 6 hours~     post-dose.~      The primary objective of the study was to determine whether any of the radiolabelled~     ketorolac formulation was deposited in the lungs of healthy volunteers following nasal~     inhalation under three different conditions (gentle sniff-inhalation with subject standing,~     vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject~     semi-supine). The secondary objectives were to determine the deposition pattern of~     radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a~     six-hour period.~   "
129819|NCT01356199|"~     The purpose of this study is to determine whether the nutritional supplement ARTRONAT~     improves the quality of life of patients with osteoarthritis.~   "
129820|NCT01356186|"~     The broad objective of this research is to effectively utilize a unique window of~     opportunity during the hospitalization period following a recent suicide attempt to deliver~     a brief and targeted intervention for traumatized individuals.~   "
129821|NCT01356173|"~     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,~     tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally~     (PO).~   "
129822|NCT01356160|"~     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response~     Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a~     and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus~     Infection.~   "
129823|NCT01356147|"~     To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator~     associated pulmonary infections. Dornase alfa has been effective in the treatment of~     pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The~     bacteria causing pulmonary infections in cystic fibrosis patients is similar to those~     infecting preterm infants. The investigators expect that dornase alfa therapy will improve~     recovery from ventilator associated pulmonary infections in preterm infants.~   "
129824|NCT01356134|"~     The investigators propose that evidence of chronic cerebrospinal venous insufficiency~     (CCSVI) may be evident in the vasculature of the fundus. The investigators will be examining~     fundi of multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI~     can be found in these patients having high risk for CCSVI. The investigators will read the~     fundus photos, compared to age-matched normals in a blind fashion.~   "
129825|NCT01356121|"~     To compare effects of sedation for upper gastrointestinal endoscopy with propofol and~     midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics~   "
129826|NCT01356108|"~     The purpose of this registry is to retrospectively and prospectively obtain clinical data in~     consecutively treated patients, in order to demonstrate that the commercially available~     Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for~     patients with pulmonary regurgitation or stenosis.~   "
129874|NCT01355471|"~     This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with~     facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel,~     applied topically once daily is more efficacious than vehicle and provides an acceptable~     safety profile in the treatment of facial erythema associated with rosacea.~   "
129827|NCT01356095|"~     Despite increased emphasis on evidence based practice in recent years a gap remains between~     evidence and practice, particularly in resource poor countries. Few studies to date have~     examined the use of knowledge translation strategies to improve health care outcomes in low~     income countries. However, given that the majority of health care in these settings is~     provided by workers with less training and limited resources, the theoretical potential for~     knowledge translation strategies to improve health care delivery and outcomes by integrating~     best evidence into routine practice may be greatest in these settings.~      Knowledge translation (KT) is an approach to changing health care provider behavior to~     reduce the gap between evidence and practice in health care delivery. There has been a~     tendency for knowledge translation interventions to employ generic, off the shelf,~     strategies, and apply them to deal with specific issues. This generic approach, fails to~     recognize the variability in the specific characteristics of health care settings, in terms~     of their patient populations, health care systems, and health care providers. These~     characteristics, whether they function as barriers or facilitators to change, make a~     generalized approach to KT ineffective, where a tailored strategy, which specifically~     adjusts its approach to measured local barriers and facilitators may achieve better~     alignment of practice to evidence. This is likely to be particularly true in low income~     countries where the majority of health care is provided by non-physician health care~     workers, working within a wider range of health care systems, with variable and unique~     patient populations and resource constraints. Given the potential to significantly impact~     health care outcomes at relatively low cost, further research is needed both to develop~     methods for identifying potential barriers and facilitators to KT strategies in specific~     resource poor settings, and to evaluate the effectiveness of KT strategies tailored to~     address the identified barriers.~      This study will assess the effectiveness of a two part knowledge translation intervention~     tailored to address factors identified in a previous study as functioning as barriers and~     facilitators to treatment adherence among patients on treatment for tuberculosis or combined~     tuberculosis and antiretroviral treatment, targeting improved patient adherence and health~     outcomes, in a specific low income country.~   "
129828|NCT01356082|"~     A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™~     Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings~     and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical~     decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we~     will test it during the perioperative care of children.~   "
129829|NCT01356069|"~     Subjects affected with severe Borderline Personality Disorder (BPD) are often heavy users of~     Mental Health Services (MHS). This study evaluates the efficacy of the addition of~     Sequential Brief Adlerian Psychodynamic Psychotherapy (SB-APP) to the treatment-as-usual~     (TAU) for BPD compared to the TAU alone for a naturalistic group of heavy MHS users with~     BPD. The efficacy was evaluated after at 6 time points along a two years of follow-up.~      Thirty-five outpatients eligible for the study were randomly assigned to two treatment~     groups (TAU=17; SB-APP=18). The Clinical Global Impression (CGI) and the CGI-modified~     (CGI-M) for BPD, the Global Assessment of Functioning (GAF), the State-Trait Anger~     Expression Inventory (STAXI), and the Symptom Checklist-90 Revised (SCL-90-R) were~     administered at T1, T3, T6, T12, T18, and T24. At T12 also the Working Alliance~     Inventory-Short Form (WAI-S) was filled-in by participants and compared between groups. In~     the one-year follow-up the SB-APP group did not receive any individual psychological~     support. MHS was specifically trained in BPD treatment and had regular supervisions.~      Scores of the CGI, GAF, and STAXI improved after 6 and 12 months, irrespective of treatment.~     SB-APP group displayed a better outcome for impulsivity, suicide attempts, chronic feelings~     of emptiness and disturbed relationships. The results displayed a good stabilization during~     follow-up year even after the interruption of psychotherapy in the SB-APP group.~      Even though the TAU for BPD applied to heavy MSH users displayed some efficacy in reducing~     symptom expression and improving global functioning, the adjunct of a specific time-limited~     and focused psychotherapeutic treatment reached a better outcome. In particular the~     possibility of a focus on patients' personality functioning (SB-APP) with a specific~     psychotherapeutic approach seemed to be more effective than the general support to social~     impairment offered by the TAU approach.~   "
129830|NCT01356056|"~     The purpose of this research study is to design, implement, and clinically assess a~     portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The~     current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale~     (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to~     develop a quantitative system, Kinesia HomeView, to assess tremor as well as different~     features of bradykinesia in a home based system which can capture those symptom changes over~     the course of a day and aid in evaluating treatment protocol efficacy.~   "
129831|NCT01356043|"~     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of~     S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine~     monotherapy.~   "
129832|NCT01356030|"~     The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1)~     endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush~     biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most~     centers, the specific method used depends on the availability of the technology and local~     expertise. Although it is believed that EUS-FNA is more accurate than ERCP brushings, there~     have been no head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is~     superior to ERCP in obtaining tissue biopsies of pancreaticobiliary tumors, and the~     investigators aim to directly compare the two techniques.~   "
129833|NCT01356017|"~     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of~     Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan~     monotherapy.~   "
129834|NCT01356004|"~     Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis~     may be difficult and cyclosporine can induce some remission.~      The investigators hypothesized that the combined use of live attenuated varicella vaccine as~     an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis~     can give positive responses.~   "
129835|NCT01355991|"~     To determine the acute and chronic effects of a short course of treatment on spinal cord~     injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂~     agonist (Salmeterol) on:~        -  Fraction of expired NO (FeNO)~        -  Selected Biomarkers of inflammation in exhaled breath condensates (EBC)~        -  Pulmonary function, as measured by pulmonary function tests and body plethysmography~   "
129836|NCT01355978|"~     When using the Breathe Technologies Ventilation System during simulated activities of daily~     living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD)~     will be comfortable and report acceptability.~   "
129837|NCT01355965|"~     To determine the safety and manufacturing feasibility of IV autologous chimeric immune~     receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a~     single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell~     receptor domain and the 4-1BB costimulatory domain.~   "
129838|NCT01355952|"~     The aim of this study is to collect pilot data to compare the effectiveness of treatment~     with Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with~     schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators~     also plan to test the feasibility of utilizing ALA as a weight loss agent for obese~     outpatients with schizophrenia or schizoaffective disorder in terms of tolerability,~     schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic~     participants and are now recruiting diabetic patients in hopes of comparing the two groups.~   "
129839|NCT01355939|"~     The proposed study will compare the benefits, harms, and comparative effectiveness of~     intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in~     reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual~     patient subpopulations and clinical circumstances. A subset of the data will be analyzed to~     compare the benefits, harms, and comparative effectiveness of the laparoscopic and open~     approaches to adhesiolysis. A comprehensive array of health-related risk factors and~     patient-centered outcomes will be assessed in the investigators diverse patient population~     for proper multivariate data analysis.~      Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal~     barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior~     ventral hernia repair.~      Specific Aim II: To evaluate and compare the adhesion-related complications and~     adhesiolysis-related complications of intraperitoneal barrier-coated versus~     non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.~      Specific Aim III: To determine the comparative effectiveness of intraperitoneal~     barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions,~     adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations~     and clinical circumstances.~      Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the~     laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior~     ventral hernia repair.~      Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open~     approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia~     repair.~   "
129840|NCT01355926|"~     The purpose of this study is to help us to better understand the effects of two different~     types of surgical techniques on pain and quality of life in patients with precancerous~     lesions or early stage mouth cancers.~   "
129841|NCT01355913|"~     In myelodysplastic syndromes (MDS) the knowledge about chromosomal aberrations is important~     for diagnosis, pathogenesis, prognosis and treatment. Usually, chromosomal anomalies in MDS~     patients are detected in bone marrow cells by chromosome banding analyses of metaphases.~     Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization~     (FISH). The investigators here present a novel method for cytogenetic monitoring of MDS~     patients from peripheral blood which is representative for the clone size in bone marrow~     cells. The purpose of this prospective multicenter non-interventional diagnostic study is to~     detect and to follow chromosomal aberrations from peripheral blood closely, to assess~     karyotype evolution, to detect rare abnormalities and to correlate the molecular-cytogenetic~     results with peripheral blood counts, bone marrow morphology and treatment modalities and~     responses.~   "
129842|NCT01355900|"~     Different strategies of tourniquet application during elective primary total knee~     arthroplasty are thought to be associated with different outcomes. In that context, the~     study investigates different tactics in the search of optimal application of the tourniquet~     and the related fluid management during 24 perioperative hours.~   "
129843|NCT01355887|"~     The purpose of this study is to better comprehend the benefits and efficacy of portal triad~     clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative~     trial was performed to compare PTC(pringle triad clamping) with either infrahepatic IVC~     clamping or low central venous pressure in complex liver resections.~   "
129844|NCT01355874|"~     Primary Objective:~      To evaluate the effect of iferanserin ointment on cessation of bleeding when administered~     intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal~     hemorrhoids.~      Methodology:~      Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group,~     placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.~      Study Treatment Duration:~      Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12~     months (open-label part of the study in which there will be a scheduled visit every three~     months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be~     treated with open-label iferanserin for 7 days followed by a 21-day follow-up period).~      Criteria for Evaluation:~      Primary Endpoint:~      The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the~     remainder of the treatment period (through Day 14).~   "
129845|NCT01355861|"~     The purpose of this study is to determine the benefits of negative work progressive~     resistance exercise (PRE) for the conservative management of sarcopenia in older male~     Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in~     metabolic and inflammatory markers, muscle morphology, strength, and functional status.~   "
129846|NCT01355848|"~     The aim of the study is to refine, elaborate, and pilot a brief intervention for adult~     patients following a suicide attempt provided during hospitalization in an acute medical~     setting. 40 participants will be randomized to receive the brief intervention + care as~     usual or only care as usual. It is hypothesized that the intervention will be acceptable and~     feasible to both patients and intervention clinicians.~   "
129847|NCT01355835|"~     12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best~     individual subthalamic nucleus stimulation and dopaminergic medication will be included into~     this randomised double-blind cross-over two-armed clinical trial. The treatment consists of~     two different stimulation settings using (i) conventional stimulation of the subthalamic~     nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the~     subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata~     [STN+SNr].~   "
129848|NCT01355822|"~     Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical~     underlying placental pathology revealing small placentas and maldevelopment of the decidual~     blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide~     (NO) donors can improve decreased uteroplacental perfusion without any negative effects on~     fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.~      The aim of this study is to evaluate the effectiveness of the long-lasting NO donor~     pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes~     (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm~     delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid~     gestation.~   "
129849|NCT01355809|"~     The purpose of this study is to evaluate effects of inspired gas mixtures on the distance~     walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a~     Six-Minute Walk test.~   "
129850|NCT01355796|"~     Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and~     recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt~     concentration has been shown to increase activity of salt sensitive antimicrobial peptides.~      Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate~     immunity.In this study, the investigators plan to study the safety and efficacy of 2 weeks~     of inhaled xylitol compared to 2 weeks of hypertonic saline in a randomized crossover design~     in stable subjects with cystic fibrosis~   "
129851|NCT01355783|"~     The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP~     has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in~     first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).~   "
129852|NCT01355757|"~     Randomized controlled trial on efficacy of single injection or continuous interscalene~     brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.~   "
129853|NCT01355744|"~     About spider bites in Middle Europe, there are published only a dozen cases. The~     investigators suspect that they may be much more frequent than reflected by the literature~     analysis (but much less dangerous than thought by people). From June 1st 2011 to November~     30st 2012 the investigators collect clinical data on patients treated for spider bites in~     Switzerland.~   "
129854|NCT01355731|"~     Professional therapeutic boundaries are defined as the limits that protect the space between~     a professional's power and patient's vulnerability. It is important to develop therapeutic~     alliances while maintaining boundaries, thus ensuring nurses develop safe connections with~     patients and their families based on therapeutic needs. Due to the professional nature of~     nursing, boundary violations are common. For example, closeness and familiarity develops~     between the healthcare provider, patient, and caregiver that encompass the physical,~     emotional, and spiritual realms. This provides an opportunity for intense bonds with~     patients and families. Furthermore in oncology healthcare, providers deliver compassionate~     care and empathize with patients and families while sharing in the patient's illness~     journey. As a result of these bonds and relationships the nurse may over disclose personal~     information, provide excessive patient attention, meeting their own personal needs instead~     of the patient and family. In addition, continuity of care contributes to boundary crossings~     because there is frequent repeated contact with the same patients and families which allows~     blurring of boundary lines. When staff spend weeks, months, or even years with the same~     patient the opportunity to connect and talk about personal life details exist. At the~     national level, the National Council of State Boards of Nursing (NCSBN) has created~     materials for educating nurses in maintenance of therapeutic boundaries. Adherence to~     therapeutic boundaries has now become an education objective, with the development of~     educational interventions within many health care settings. Likewise, St. Jude nurses are at~     an increased risk of crossing therapeutic boundaries due to long term care relationships and~     vulnerable family members. However, nursing administration has not formally assessed the~     attributes or behaviors of the nursing staff. This proposal will describe the attributes and~     behaviors of the St. Jude staff nurse towards nurse-patient/family boundaries, providing~     knowledge to nursing leadership that will facilitate therapeutic boundaries focus groups~     with direct care nurses.~   "
129855|NCT01355718|"~     This trial is conducted in Asia. The primary objective of this study is to evaluate the~     clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue~     combination therapy in type 2 diabetes under normal clinical practice conditions in Korea~     while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks~     of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal~     clinical practice conditions in Korea.~   "
129856|NCT01355705|"~     We hope to learn if amrubicin is safe and useful for patients with multiple myeloma that~     requires additional treatment.~   "
129857|NCT01355692|"~     The population of people suffering from diabetes is rapidly increasing, from an estimated~     110 million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason~     for reduction in visual acuity in diabetic patients.~      The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation.~     During photocoagulation, small laser burns are applied to the retina, the sensory tissue~     that lines the back of the eye. Studies have shown that photocoagulation of clinically~     significant diabetic macular edema substantially reduces the risk of visual loss, increase~     the chance of visual improvement and decrease the frequency of persistent macular edema.~     However, it remains unknown whether the destruction of sensory layer of the retina during~     photocoagulation that may cause visual field defects is necessary for successful treatment~     or is just an unwanted and unnecessary side effect.~      Based on these concept, a photocoagulation technique was developed to treat the retina~     selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory~     layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses~     much lower energy and very short pulses. As a result, treatment does not result in visible~     burns to the retina and previous studies have shown that the sensory layer remains intact.~      The aim of this study is to determine the effect of SRT on the resolution of the edema.~   "
129858|NCT01355679|"~     The purpose of this study is to test the feasibility (ability to be done) of an experimental~     test to help plan your cancer treatment. This study plan is not studying the effectiveness~     of the proposed combinations of therapy for your cancer that you may receive after the~     experimental testing.~      This study will look at an experimental technology to determine a tumor's molecular makeup~     (gene expression profile). This technology (called OncInsights) is being used to discover~     new ways to understand cancers and potentially predict the best treatments for patients with~     cancer in the future. The experimental technology has not been approved by the U.S. Food and~     Drug Administration.~   "
129859|NCT01355666|"~     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will~     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and~     shearing among residents of Nursing Homes.~   "
129860|NCT01355653|"~     This study is designed to compare the safety, as measured by skin findings and adverse~     events, of two different heat devices in elderly, overweight, and elderly and overweight~     subjects.~   "
129861|NCT01355640|"~     1. The purpose of this study is to research and compare two sucking modes'~          effect(breast-feeding and non-nutritive sucking) and difference,hypothesis is that~          these two kinds of methods can decrease pain for Chinese term infants receiving heel~          stick.~        2. A convenient sample of 90 neonates from a hospital in Beijing undergoing heel stick for~          Newborn Screening Program Blood Test were enrolled. They were randomized into three~          groups:~             -  breast-feeding group~             -  non-nutritive sucking group~             -  control group~        3. The results showed that:~             -  Breast-feeding can reduce crying and grimace time, increase oxygen saturation.~             -  Non-nutritive sucking can delay grimace's starting time, increase oxygen~               saturation.~   "
131494|NCT01334099|"~     The purpose of this study is to determine the maximum dose of CP-675,206 when given in~     combination with radiation. Patients will be given local radiation to one tumor site and an~     intravenous infusion of CP-675,206.~   "
129862|NCT01355627|"~     The primary objective is to demonstrate superiority of TachoSil® compared to current~     practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing~     must be evaluated post-operatively. The secondary objective is to evaluate the safety of~     TachoSil® as an adjunct in sealing the dura mater.~      The trial population will consist of 726 randomised (1:1) patients elected for skull base~     surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1~     weeks and safety follow-up 28±2 weeks after surgery.~   "
129863|NCT01355614|"~     This study will assess the safety and efficacy of QAX576 if patients with fistulizing~     Crohn's disease.~   "
129864|NCT01355601|"~     This clinical trial will determine the effect of varying types of carbohydrates on~     children's concentration.~   "
129865|NCT01355588|"~     This was a phase 1, double-blind, 4-way crossover study in healthy male and female~     volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg.~     There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects~     were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine~     alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine~     hydrochloride. At the end of the study each subject had received all 4 treatments.~      The primary objective of this study in healthy volunteers was to compare the safety,~     tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary~     objective was to monitor lidocaine hydrochloride plasma levels.~   "
129866|NCT01355575|"~     TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Proof-of-principle, open-label,~     randomised, cross-over, controlled study HYPOTHESIS Reduction in gut flora by the antibiotic~     Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH).~      AIMS To provide proof-of-concept data on the therapeutic potential of gut flora modification~     in NASH OUTCOME MEASURES~      Primary:~      • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of~     therapy~      Secondary:~        -  Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance~          spectroscopy (1H MRS)~        -  Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic~          clamp~        -  Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and~          fluorescent in-situ hybridisation (FISH)~        -  Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear~          magnetic resonance spectroscopy~      POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently~     raised serum aminotransferase levels~      TREATMENT The non-absorbable antibiotic Rifaximin DURATION Study duration 18 months.~     Individual patients' participation 18 weeks, with clinical follow-up 3 months after the end~     of the study.~   "
129867|NCT01355562|"~     The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.~   "
129868|NCT01355549|"~     Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by~     overuse injuries to the muscles and tendons that can occur during wheelchair propulsion,~     transfers, and other activities of daily living. Normally, shoulder pain resolves with~     conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen,~     naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery~     may be the only option.~      Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and~     tendon injuries such as those that cause shoulder pain in persons with SCI. Using one's own~     blood, cells within the blood called platelets are concentrated and then re-injected into~     the muscle and tendon of the shoulder. These platelets release substances known as growth~     factors that lead to tissue healing. By concentrating the platelets we increase the growth~     factors up to eight times which will promote the healing of tendons. PRP therapy has shown~     promise in treating tendon and muscle injuries in able-bodied persons; however, its~     effectiveness in persons with SCI is unknown. The purpose of this study is to explore the~     feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with~     SCI. The human body has a remarkable ability to heal itself and we hypothesize that~     re-injecting concentrated platelets will facilitate the natural healing process and will~     reduce shoulder pain in persons with SCI.~   "
129869|NCT01355536|"~     The prevalence of preterm birth is rising in most western countries. The causes of preterm~     birth is not fully understood and seem to be multifactorial. The endocrine and metabolic~     aspects are scarcely investigated.The main purpose of this study is to test the hypothesis~     that endocrine and metabolic factors associate to preterm births.~   "
129870|NCT01355523|"~     The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week~     preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive~     function and sleep disturbances in breast cancer patients. Furthermore the investigators~     will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of~     depression, sleep disturbances or cognitive dysfunction.~   "
129871|NCT01355510|"~     Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial~     pressure in patients with refractory hypertension. The reduction in blood pressure seems to~     be mediated through sympathetic inhibition with concomitant reduction in the activity of the~     renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by~     decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma~     renin concentration also decreases with acute electrical baroreflex stimulation.~      In some patients chronic baropacing is associated with long-term blood pressure reduction.~      However, there is sparse information as to the relative contribution of blood pressure~     regulating systems to account for the acute and chronic effects of baropacing. Sympathetic,~     renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of~     electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact~     between the stimulating electrodes and the baroreceptor afferents.~      This study is designed to answer the following primary questions:~        1. Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic~          vasoconstrictor tone also in the long-term?~        2. Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing?~          Such an increase would confirm electrical integrity of the system and proper contact to~          the baroreceptor afferents.~        3. Does acute electrical baroreflex stimulation decrease renal vascular resistance?~        4. Does acute electrical baroreflex stimulation influence glucose delivery to skeletal~          muscle and change insulin sensitivity? The study follows an open-label observational~          design and it is planned to recruit up to 30 patients over 3 years.~   "
129875|NCT01355458|"~     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema~     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once~     daily is more efficacious than vehicle and provides an acceptable safety profile in the~     treatment of facial erythema associated with rosacea.~   "
129876|NCT01355445|"~     This is an international open-label, randomized, multicenter phase II study of VIT and VI~     for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will~     evaluate the safety and efficacy of these combinations in patients with recurrent or~     refractory rhabdomyosarcoma.~   "
129877|NCT01355432|"~     This is a prospective pilot study to quantify the changes in heart rate when propofol is~     administered after inhalational anesthesia induction.~   "
129878|NCT01355419|"~     In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very~     poor. The investigators can suppose that with continuous positive airway pressure (CPAP)~     therapy, there is an improvement in sleep quality, such that patients need less sleep to be~     fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been~     studied. The investigators have planned to study sleep schemes before and after CPAP therapy~     in moderate to severe sleepy OSA patients.~   "
129879|NCT01355406|"~     This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to~     cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal~     artery. The arteries are often abbreviated as femoropopliteal.~      The intent of this study is to demonstrate that the FlexStent® Femoropopliteal~     Self-Expanding Stent System is safe and effective for the treatment of patients with~     peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed~     safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in~     patients with symptomatic peripheral arterial disease.~   "
129880|NCT01355393|"~     This randomized phase I/II trial studies the side effects and best dose of rintatolimod when~     given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in~     treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive~     breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an~     effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies,~     such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary~     treatment to lower the risk that the cancer will come back and are one way to help vaccines~     produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or~     GM-CSF may be a safe and effective treatment for breast cancer.~   "
129881|NCT01355380|"~     This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for~     treatment with Ventavis.~      Typical clinical measures and quality of life will be prospectively followed in 12 months~     period.~   "
129882|NCT01355367|"~     This is a clinical study evaluating the safety and efficacy of long term administration of~     oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for~     whom the test drug is tolerable during the 8 week double blind treatment phase of Study~     13176.~   "
129883|NCT01355354|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     digoxin by comparing the safety, tolerability and plasma concentration of digoxin when~     administered alone and with fostamatinib in healthy subjects.~   "
129884|NCT01355341|"~     More specifically, the present invention relates to a 'Herbal Preparation' that is useful~     for~        -  Treatment of Renal calculi~        -  Reduction in the stone size & surface area~        -  The expulsion of stone~        -  Decreased need of Analgesic(Antiinflammatory Effect)~        -  Stops the recurrence and reformation of renal~   "
129885|NCT01354340|"~     The principal objective of this study is to investigate the dose-effect of the Limicol food~     supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.~   "
129886|NCT01354327|"~     The principal objective of this study is to investigate the effects of a novel food~     supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate~     hypercholesterolemia.~   "
129887|NCT01354314|"~     The purpose of this study is to see if paroxetine and fluconazole are safe and effective as~     a treatment for problems with memory, concentration, thinking, and judgment in people who~     are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major~     depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal~     infections.~   "
129888|NCT01354301|"~     Despite the improvement of efficacy results with current immunosuppressive regimens (about~     15% of incidence of acute rejection), the security schemes used do not show the same~     results.The most worldwide used regime is tacrolimus, mycophenolate and prednisone. Despite~     the favorable efficacy results in our population, the use of this combination is associated~     with higher incidence of viral infections such as cytomegalovirus, and gastrointestinal~     events, two common causes of hospital readmissions after renal transplantation at our~     institution.Given this, the investigators propose a study of our own initiative that attends~     our local needs: identify the best strategy among the therapeutic options available to~     maintain the result of current effectiveness and improve the safety profile for kidney~     transplant recipients.This protocol is a prospective, randomized, single center, designed to~     compare the safety and efficacy of three immunosuppressive regimens: (1) single dose of~     antithymocyte globulin, reduced exposure to tacrolimus, everolimus starting on day 2 after~     transplantation and prednisone; ( 2) basiliximab, reduced exposure to tacrolimus, everolimus~     starting on day 2 after transplantation and prednisone; (3-control group) basiliximab,~     reduced exposure to tacrolimus, mycophenolate and prednisone.Our hypothesis is that a single~     dose of antithymocyte globulin or basiliximab induction therapy in combination with low~     doses of tacrolimus, everolimus and prednisone results in comparable efficacy observed in~     patients receiving tacrolimus / mycophenolate / prednisone, but with a better safety~     profile.~      To ensure efficacy, the investigators added to the regimes the induction with monoclonal or~     polyclonal antibody. To improve the toxicities associated with the current scheme, the~     investigators replace the use of mycophenolate by everolimus and the investigators reduced~     the dose of tacrolimus.~      Patients will be monitored for blood levels of tacrolimus and everolimus to ensure adequate~     exposure to immunosuppressive agents.~   "
129889|NCT01354288|"~     DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific~     educational tool in order to assess its impact on glycemic control, quality of life,~     knowledge about the disease and its daily management, over a period of 2 years. The~     investigators plan to include 300 type 1 diabetic children in 10 french hospitals.~   "
129890|NCT01354275|"~     Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone~     (GnRH) agonist and GnRH Antagonist fixed protocol.~   "
129937|NCT01354756|"~     Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric~     surgery. There is a need for alternative screening tools for sleep apnea detection in the~     pre-operative period. The investigators would like to compare ApneaLink and complete~     polysomnography in this population.~   "
129891|NCT01354262|"~     This is a prospective, randomized, non-blinded interventional study that will investigate~     the effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes~     mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting~     vitamin D deficiency will alter the HbA1c level in patients with type 2 DM and lower than~     normal vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases~     HbA1c levels in patients with type 2 DM and vitamin D deficiency.~   "
129892|NCT01354249|"~     Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks~     have been tested and they may reduce insulin resistance. No study so far has aimed to~     examine the possible benefits of whey protein drink in the composition of preoperative~     drinks.~   "
129893|NCT01354236|"~     This study aims to investigate psychosocial risk- and protective factors such as psychiatric~     disorder, socio-economic background and family functioning among school dropouts and to~     compare the findings with those by a matched control group of regularly enrolled students.~   "
129894|NCT01355328|"~     In this study, the investigators will evaluate the potential of multiphoton microscopy as a~     non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue~     reaction. The investigators will also investigate drug delivery using multiphoton~     microscopy.~   "
129895|NCT01355315|"~     Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that~     has been as a treatment option for refractory angina in left ventricular (LV) dysfunction.~     Recently, its potential role in heart failure management has been shown. However, although~     the concept of EECP was introduced almost four decades ago, and despite growing evidence~     supporting the clinical benefit and safety of this therapeutic modality, little is firmly~     established regarding the mechanisms responsible for the benefit of EECP include improvement~     in endothelial function, promotion of coronary collateralization, enhancement of ventricular~     function, and peripheral effects. Therefore, the major aim of this study is to provide an~     alternative treatment, EECP, for those unsuitable for standard procedures, especially for~     patients whose heart failure was caused by repeated myocardial infarction, called ischemic~     cardiomyopathy (ICMP), and to evaluate the clinical outcome and the endothelial function~     before and after 35 hours of EECP treatment.~   "
129896|NCT01355302|"~     The purpose of this study is to determine the following: 1. Find the maximum tolerated dose~     of E7050 when given in combination with cisplatin and capecitabine in patients with advance~     or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and~     capecitabine is more effective in patients with previously untreated gastric cancer versus~     cisplatin and capecitabine alone.~   "
129897|NCT01355289|"~     The study will have three phases: Prerandomization, Randomization (Core Study), and~     Extension. The Randomization Phase may include Treatment Periods A1 and A2 (depending~     when/if subjects enter the open-label extension, and a follow-up period (for those subjects~     not continuing into the open-label extension). The open-label extension may include~     Treatment Periods B1, B2, and B3 (depending on when subjects enter the open label~     extension), and a follow-up period. Subjects may be followed for sustained viral response,~     if appropriate. In the Core Study (randomization phase) subjects will be randomized (in a~     1:1:1:1 ratio) to receive one of four treatments (placebo or E5501 [10mg, 20mg, and 30mg]~     for up to 21 days. Subjects will successfully complete Treatment Period A1 once their~     platelet counts are sufficient to enable initiation of antiviral treatment with PEG-IFN. The~     open label extension period will consist of up to three (depending on if/when subjects~     enter) Open-label Treatment Periods (B1, B2, and B3) and a follow-up period. During~     open-label treatment, all subjects will begin once-daily treatment with E5501 at a dose of~     20 mg. In Treatment Periods B2 and B3, subjects will be allowed to have their E5501 dose~     titrated up or down in accordance with their individual response, within the range of a~     minimum of 5mg and a maximum of 50mg.~   "
129898|NCT01355276|"~     The purpose of this study is to compare Cinitapride tablets with domperidone tablets~     (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment~     of mild to moderate functional dyspepsia.~   "
129899|NCT01355263|"~     The investigators plan to perform a randomized, mutual-control and double-blinded cohort~     study to further exploit the vitamin A supplementation on iron metabolic homeostasis~     (including iron reserve, mobilization and absorption status in the same population) compared~     with solely iron and vitamin A plus iron.~   "
129900|NCT01355237|"~     This research study is being done to understand the outcomes of back pain treatment and~     costs associated with it in an academic hospital outpatient setting. The investigators will~     conduct a prospective observational cohort study to assess the clinical outcomes and~     utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic~     low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated~     within Brigham and Women's Hospital. Outcomes will include assessment of functional status,~     symptom relief, satisfaction with care, health-related quality of life, and worker~     productivity, and will be measured in person at baseline, and by phone by an interviewer~     blinded to cohort group at 3, 6, and 12 months.~   "
129901|NCT01355224|"~     This study will examine the impact of providing genetic risk information for obesity on~     people's attitudes and beliefs about obesity, health behaviors and weight outcomes.~     Specifically, this study will examine the feasibility of using genetic information to~     motivate efforts to reduce obesity among individuals recruited to the Coriell Personalized~     Medicine Collaborative (CPMC), see below for description of CPMC.~   "
129938|NCT01354743|"~     The purpose of this study is to provide data to support combination treatment of the upper~     face with Perlane-L® and Dysport™. This study will assess the outcome of upper face~     rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also~     be assessed as a secondary endpoint.~   "
129940|NCT01354717|"~     This is a double-blind, randomized, placebo-controlled, three treatment parallel study in~     which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on~     the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals~     (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be~     counted at the baseline visit and at the visit four weeks following cessation of treatment.~   "
130547|NCT01346670|"~     The objective of the study is to evaluate the relative bioavailability of lovastatin and its~     ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor®~     Tablet after single oral administration in healthy subjects using a 2x2 crossover design.~   "
129902|NCT01355211|"~     The aim of the proposed research is to compare the diagnostic accuracy of a portable~     wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in~     identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status~     epilepticus) in emergency department (ED) patients with altered mental status. Comparing the~     the accuracy of EEG recordings and interpretations of Micro-EEG to those of standard EEG~     will allow the investigators to assess the utility of this novel device in the ED patients~     with altered mental status. The unique qualities of Micro-EEG device could potentially~     facilitate easier access to EEG test in all ED patients.~      This study will also provide valid information regarding the prevalence of non-convulsive~     seizure in ED patients with altered mental status.The gold standard for diagnosing~     non-convulsive seizure would be standard EEG.~      All study participants will undergo electroencephalography using the two devices (standard~     EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized~     order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG~     electrodes, and 3. Micro-EEG with Electro-Cap electrodes.~   "
129903|NCT01355198|"~     HIV infection is associated the development of increased oxidative stress and deficiency of~     glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying~     mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism~     has not been studied in HIV patients, in whom the burden of risk factors promoting oxidative~     stress is highest. Our previous studies in non-HIV human subjects with diabetes-related~     oxidative stress and GSH deficiency have demonstrated that the latter is due to decreased~     synthesis of GSH. Importantly, short-term dietary supplementation with the simple GSH~     precursor amino-acids cysteine and glycine, boosted GSH synthesis and cellular~     concentrations, corrected GSH deficiency, and reduced oxidative stress and oxidant damage.~     The current proposal will study whether (1) defective synthesis underlies GSH deficiency in~     patients with HIV, and will test a simple, inexpensive and rational therapy based on protein~     supplementation to improve GSH synthesis and concentrations and lower markers of oxidative~     stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is~     asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and~     insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry;~     (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in~     these subjects.~   "
129904|NCT01355185|"~     There are substantial uncertainties with contemporary seed placement techniques in prostate~     brachytherapy, particularly with the impact of seed movement after an implant due to edema~     and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20~     patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at~     specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these~     phenomena.~   "
129905|NCT01355172|"~     The purpose of this study is to evaluate the antibody response to each of the three~     influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by~     hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks~     apart, in infants between 6 and 12 months of age.~   "
129906|NCT01355159|"~     The hypothesis of the study is: high dose (4.0 mg per day) supplementation for pregnant~     women at high risk of developing preeclampsia starting in early pregnancy and continued~     throughout the entire pregnancy will lower the incidence of preeclampsia.~   "
129907|NCT01355146|"~     The purpose of this study is to proof increasing patient satisfaction and preservation of~     quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement~     Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the~     clinic or at doctor's practice.~   "
129908|NCT01355133|"~     The purpose of this pilot clinical study is to determine if intrasphincteric autologous~     myoblast injections in combination with electrical stimulation are safe and effective in~     treating stress urinary incontinence, confirming the optimal dose and assessing tolerability~     of the procedure.~   "
129909|NCT01355120|"~     This is an open-label, multi-center, single-arm clinical phase II study to further~     characterize the efficacy and safety of ipilimumab in patients with or without systemic~     pretreatment metastatic ocular melanoma.~      The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because~     sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited.~     In order to allow the separate subgroup analysis as planned in the protocol for ocular~     melanoma it is mandatory to focus the recruitment to this patient population. Only this will~     guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas~     originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE~     Pathology of ocular melanomas British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The~     same criteria and treatment procedure as those used before will be applied for the patients~     with advanced ocular melanoma. Since no treatment standard in those patients does exist,~     also patients without prior systemic treatment can be included in this study. Therefore, the~     5th inclusion criterion has been adapted in order to enrol the eligible patients.~   "
129910|NCT01355107|"~     The incidence of hepatocellular carcinoma (HCC) is rising worldwide.One important etiology~     is a chronic inflammation due to hepatitis c (hcv) infection. Over the steps of a chronic~     inflammation over the stadium of cirrhosis of the liver it is possible that neoplastic~     nodules appear in the liver which can rise up to a HCC. In the pathogenesis of HCC oxidative~     stress seems to play an important role and as selenium is a key micronutrient in this~     process its levels could differ between the different stages of disease in hcv- infected~     patients. The aim of this trial is to examine these differences.~   "
129939|NCT01354730|"~     This was a retrospective cohort study of pregnant women who had received the AdimFlu-S~     (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed~     by chart review. If subject meets the eligibility criteria during the study period, data~     from the medical chart were extracted retrospectively from the date of vaccination and the~     infant (s) health status were followed until 8 weeks after the delivery.The unexposed cohort~     included pregnant women who did not receive any influenza vaccine during pregnancy. Within~     each participated study center, women who were gestation after April 2009 were randomly~     selected according to maternal age matching. The pregnancy outcome, including the status of~     delivery, abortion and gestational age, were extracted retrospectively by chart review.~   "
129911|NCT01355094|"~     This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid~     through the use of a commercial suction device compared to passive drainage of the same~     peritoneal fluid drained through standard surgical drains under bulb suction only, in~     critically ill patients who require an open abdomen. Both techniques being used, the~     commercial KCI AbThera™ device and home made Stampede VAC system, are currently approved~     for use in Canada and used in our facility.~      The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension~     (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if~     so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to~     leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal~     closure (TAC) techniques, resulting in an open abdomen(OA). The decision to accept an OA~     can only be made in the operating room and is typically made quite arbitrarily (there is no~     current standard or protocol),and the TAC used is based on the surgeon's best judgment. The~     study intends to randomize patients after it has been decided that a TAC is required, which~     will be applied in the operating room while the patient is fully anesthetized. The only~     intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the~     evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal~     fluid-that is typically discarded in patients with OA.~   "
129912|NCT01355081|"~     The purpose of this study is to assess the efficacy, safety and tolerability of 8-week~     treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with~     major depressive disorder.~      The purpose of this study is to assess the efficacy, safety and tolerability of 8-week~     treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive~     disorder.~   "
129913|NCT01355068|"~     In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and~     Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a~     pivotal bioequivalence study.~   "
129914|NCT01355055|"~     Primary hypothesis:~      Catheter-based renal denervation reduces central sympathetic activation in patients with~     refractory hypertension.~      Secondary hypotheses:~        1. The magnitude of the individual depressor response after catheter-based renal~          denervation depends on the extent of sympathoinhibition.~        2. Both, the reduction in arterial pressure and in central sympathetic activation are~          sustained over time up to 24±3 months after catheter-based renal denervation.~        3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood~          pressure values.~   "
129915|NCT01355042|"~     Severe sepsis (ie. life-threatening infections) is triggered by harmful microorganisms or~     their toxins in the blood or tissues. These harmful agents damage the lining of blood~     vessels which can lead to inflammation, blood clot formation, and vessel obstruction. In~     Canada, there are approximately 90,000 patients with severe sepsis each year. Of these, 30%~     to 50% will die. The identification of highly reliable outcome predictors in severe sepsis~     patients is important for several reasons including: to help describe the severity of~     sepsis, to classify patients for enrollment in clinical studies, and to monitor a patient's~     response to treatment and procedures. In the investigators lab, the investigators examined~     the incremental usefulness of adding multiple biomarkers to clinical scoring systems for~     predicting ICU mortality in patients with severe sepsis. In a preliminary study of 80~     patients with sepsis, the investigators found that high levels of plasma DNA predicted ICU~     death better than any other clinical or biological factor. In this grant, the investigators~     propose to confirm these findings in an external group of 400 patients in a blinded fashion.~     The investigators also plan to study how plasma DNA levels change over time and whether high~     plasma DNA levels can be used to distinguish sepsis from other critically ill conditions.~     For this the investigators will compare the investigators septic patients to a cohort of 600~     patients in the ICU with other conditions. The investigators believe this research has the~     potential to significantly improve the management and treatment of septic patients.~   "
129916|NCT01355029|"~     The study will be evaluating to a 4 week education and support program for stroke~     caregivers. The 4 week program will provide education, information, and strategies for~     dealing with areas that caregivers may find challenging in their caregiving role. The study~     will evaluate the effectiveness of the program to decrease the caregiver's stress, strain~     and burden, increase the caregiver's knowledge of strategies and community services and~     increase their role satisfaction as a stroke caregiver and quality of life two weeks after~     the program and 6 months after the program.~   "
129917|NCT01355016|"~     The purpose of this study is to determine the range of single inhaled doses of a new dry~     powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects~     on pulmonary function and determination of blood levels of MDT-637 following inhalation.~   "
129918|NCT01355003|"~     This study will collect safety information on the use of GARDASIL™ in the Philippines.~   "
129919|NCT01354990|"~     The primary objective of this study is to obtain safety information on the use of~     sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general~     practitioners.~   "
129920|NCT01354977|"~     The purpose of this research is to study the effects of a medication called resveratrol on~     the body's response to insulin (a hormone to control blood sugar), on inflammation and/or on~     specific cells and processes in fat tissue, and on skeletal muscle metabolism and on brain~     function.~   "
129921|NCT01354964|"~     The purpose of this research is to study the effects of Vitamin D supplementation on the~     body's response to insulin (a hormone that controls blood sugar), on inflammation and/or on~     specific cells and processes in fat tissue, and on function of skeletal muscle and joints.~   "
129922|NCT01354951|"~     The purpose of this study is to see what side effects a type of radiation treatment called~     focal brachytherapy has in treating early stage prostate cancer. The study is also looking~     at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the~     investigators would like to see how this type of treatment impacts quality of life.~   "
129923|NCT01354938|"~     The objective of this study was to evaluate the role of Klaricid XL (clarithromycin modified~     release) in the treatment of acute exacerbation of chronic bronchitis (AECB) and its impact~     on improving the quality of life.~   "
130548|NCT01346657|"~     The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the~     pharmacokinetics of nifedipine after administering single-dose combination to healthy~     subjects using a 2x2 crossover design.~   "
129924|NCT01354925|"~     Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for~     all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can~     induce harmful effects and complications in patients with diabetes. Several studies have~     demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during~     fasting. When treating diabetic patients with a treatment guideline the rate of these~     complications can be reduced. Little data is available on patients with type 2 diabetes~     treated with insulin. The investigators therefore propose to assess the effect of a protocol~     containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control~     in patients with type 2 diabetes during the Ramadan and to compare this regimen to the~     standard care patients receive during this period. The investigators assume that patients~     receiving the intervention will have better glucose control during the Ramadan compared to~     patients receiving the standard care. As approximately 45 million Muslims suffer from type 2~     diabetes and most of them fast during the Ramadan the results of this intervention may be~     significant and may improve the care of these patients allowing Muslims to respect their~     religious obligations without compromising their health.~   "
129925|NCT01354912|"~     Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now~     increasingly being recognized as significant causes of chronic pulmonary infection in~     immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide~     is caused by Mycobacterium avium-intracellular complex (MAC) (2-4).~      In several studies with chest computed tomography (CT), researchers have demonstrated that~     the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching~     centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the~     right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11).~     Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and~     bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT~     findings, however, may not be specific for NTM pulmonary infection. CT patterns of~     bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms~     have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium~     xenopi, and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium~     fortuitum, and Mycobacterium chelonae (12-14). In addition, not all patients with~     bronchiectasis and bronchiolitis have NTM pulmonary infection. Two recent studies showed~     that only about 50% of patients with such CT features have MAC pulmonary infection (9,15).~     To the best of our knowledge, however, there is no report about the incidence of NTM in~     patients with bronchiectasis or bronchiolitis in countries with low incidence of TB. Thus,~     the purpose of our study was to determine the frequency of NTM pulmonary infection in~     patients with bilateral bronchiectasis and bronchiolitis at chest CT and to investigate~     whether these CT findings are specifically indicative of MAC infection or other specific~     pathogen.~   "
129926|NCT01354899|"~     The rational for the study is to add a thin self-adherent dressing on critically ill~     patients. Evaluate if the dressing might protect the skin for further breakdown.Participants~     will be followed for the duration of hospital stay, an expected average of 5 days.~   "
129927|NCT01354886|"~     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of~     a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed~     female volunteers, in comparison with two marketed comparator products.~   "
129928|NCT01354873|"~     The investigators seek to compare the accuracy of the existing colonoscope model to~     determine the magnitude of the improvement the investigators can expect in polyp~     discrimination as neoplastic or non-neoplastic.~   "
129929|NCT01354860|"~     This study aims to assess the feasibility, effectiveness and safety of moxibustion for~     symptom management and function improvement in patients with knee osteoarthritis, compared~     to usual care group.~   "
129930|NCT01354847|"~     This study is planned to investigate the relationship between duration of extracorporeal~     circulation and the extent of (acquired) platelet dysfunctions in patients undergoing~     cardiac surgery.~   "
129931|NCT01354834|"~     The purpose of this study is to assess the effectiveness of Menopur to achieve clinical~     pregnancy in females undergoing intrauterine insemination in clinical practice.~   "
129932|NCT01354821|"~     The aim of this study is to prospectively compare the perioperative mortality severe~     morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and~     3 thoracal abdominal aortic aneurysms.~   "
129933|NCT01354808|"~     The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance~     to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major~     adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients~     with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary~     intervention (PCI).~   "
129934|NCT01354795|"~     EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of~     gastrointestinal track lesions and other organ lesions including mediastinal and~     intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA~     depends on several factors. For example, experience of the endosonographers, adequate~     sampling, sample preparing, accurate interpretation by the cytopathologist and on-site~     cytopathology interpretation. However, in many hospitals, no cytopathologist can be present~     during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided~     FNA are important to make correct a diagnosis without on-site cytopathologist.~      Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also~     more blood. Some endosonographers use no suction, others use constant suction. Usually~     specimen is expelled from a needle with pushing the stylet into the needle. But use of the~     stylet during EUS-FNA is difficult and time consuming process. Injecting air was not~     recommended, because of spraying out uncontrollably, increasing risk of air artifact and~     specimen clotting. However, there is no further study which one is the appropriate, suction~     or no suction and pushing the stylet or injecting air until now.~      The hypothesis and aim of the prospective randomized controlled trials are as follows:~      First hypothesis: There was no difference in the adequacy, cellularity, bloodiness,~     contamination, air artifact in specimen obtained by each methods, suction or no suction and~     pushing the stylet or injecting air.~      Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in~     specimen obtained by each methods, suction or no suction and pushing the stylet or injecting~     air.~      Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy,~     positive predictive value, negative predictive value and statistical agreement in specimen~     obtained by each methods, suction or no suction and pushing the stylet or injecting air.~      Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive~     value, negative predictive value and statistical agreement in specimen obtained by each~     methods, suction or no suction and pushing the stylet or injecting air.~   "
129935|NCT01354782|"~     The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its~     metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast~     500 μg in healthy Chinese subjects.~   "
129936|NCT01354769|"~     Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in~     the expired respiratory gases; as such, it is a non-invasive monitoring technique which~     allows fast and reliable insight into ventilation, circulation and metabolism. Capnography~     has proven to be more effective than clinical judgement alone in the early detection of~     adverse respiratory events. The shape of a capnogram is identical in all humans with healthy~     lungs; any deviations in shape must be investigated to determine a physiological or a~     pathological cause of the abnormality.~      Data from a previous pilot study yielded two major findings:~        1. Prediction of requirement for intubation, by the creation of an Integrated Pulmonary~          Index (IPI) based on non-invasive physiological parameters~        2. Breathing patterns during weaning in order to identify specific patterns used to~          predict extubation success/failure~      The intent of the current study is to gather sufficient data to either prove or disprove the~     findings of the previous study~   "
129941|NCT01354704|"~     The objectives of the study are:~      o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing~     ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA~      o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these~     patients compared with the original drug Lovenox ®.~   "
129942|NCT01354691|"~     For many, Alzheimer's disease is the number one medical issue facing our aging society. It~     is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory~     and cognitive performance. There are no known treatments that can either prevent or reverse~     its progression. Consequently, there still remains a need to evaluate treatments which can~     better stabilize the symptoms of this disease. These symptoms frequently include decreased~     functional capacity and negative psychological attributes (e,g, depression, anxiety) in~     association with the memory and cognition deficits. This current study is being done to~     assess an investigational compound that has been designed to not only improved the cognitive~     status of affected patients but to also better manage all symptoms. Hence, the ultimate goal~     is to provide patients with an improved quality of life by slowing the progression of this~     neurodegenerative disease~   "
129943|NCT01354678|"~     Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear~     cells transplantation by intramyocardial multiple precision injection in ischemic heart~     failure patients.~   "
129944|NCT01354665|"~     This study aims to evaluate the occurence and severity of fatigue and depression in multiple~     sclerosis patients and the impact of Betaferon treatment on symptoms alterations.~      The study is conducted in routine practice setting hence no interference with standard care~     takes place.~      Pharmacologic treatments of MS-fatigue and depression will also be recorded.~   "
129945|NCT01354652|"~     The purpose of this study is to investigate whether entecavir treatment increases the~     incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase~     inhibitors (NRTI), lamivudine, and/or no NRTI treatment, in patients with cirrhosis or~     hepatic failure whose Model for End stage Liver Disease (MELD) scores are over 18.~   "
129946|NCT01354639|"~     The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But~     there were no definite evidence of oncological safety of robotic thyroidectomy yet. To~     assure the surgical completeness of robotic thyroidectomy, the investigators compared~     robotic thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative~     radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.~   "
129947|NCT01354626|"~     The objective of this study is to investigate the potential beneficial effect of increasing~     protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.~      The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid~     accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced~     lipid accumulation.~   "
129948|NCT01354613|"~     Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart~     failure cases in the United States, affecting a primarily elderly population. No treatment~     has been shown to affect mortality in HFpEF, which is more than 50% at five years a~     hospitalization. This project explores the underlying cardiovascular physiology of patients~     with HFpEF with the goal of identifying new therapeutic targets that would allow improved~     treatment of this devastating disease.~   "
129949|NCT01354600|"~     The purpose of this research study is to examine the effects of overfeeding and exercise on~     blood levels of hormones associated with regulating appetite, also thought of as feelings of~     hunger and satiety (fullness). Previous studies have shown that non-obese people have~     different amounts of these hormones in their blood compared to obese people.~      The investigators hypothesize that exercise will promote improved insulin sensitivity and~     corresponding beneficial changes in obese individuals. The investigators predict exercise~     induced changes in 24-hour plasma hormone levels will be associated with improved appetite~     during overfeeding in obese individuals.~   "
129950|NCT01354587|"~     The purpose of this study is to measure the changes in the Treatment Satisfaction~     Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of~     administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects~     transitioning from subcutaneous Vivaglobin® to Hizentra®.~   "
129951|NCT01354574|"~     The purpose of this study is to determine if consumption of meals containing carbohydrates~     with different glycemic index (a high glycemic index meal and a low glycemic index meal)have~     different effects on energy expenditure, type of metabolic fuels used for energy, blood~     lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to~     satiety.~   "
129952|NCT01354561|"~     The present study investigated the influence of respiratory affections on the heart rate~     variability (HRV) of paediatric patients. We have hypothesised that respiratory~     physiotherapy would promote a beneficial effect on the cardiac autonomic modulation.~     Twenty-four children, who were divided into respiratory disease group (RG) and control (CG)~     groups, were studied. Analysis of HRV was performed with the RG in the dorsal decubitus~     position during four different moments: basal record (30 minutes); 5 minutes after~     respiratory physiotherapy by means of airway clearance techniques (10-minute record); 5~     minutes after nasotracheal suction (10-minute record); and 40 minutes after nasotracheal~     suction (30-minute record). CG group was submitted to the same protocol, except nasotracheal~     suction, which was not performed due to ethical reasons.~   "
129976|NCT01354132|"~     The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early~     phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and~     Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur~     during the pre-illness phase and around the transition to psychosis. Therefore, studying new~     treatments that could target changes occurring during this period is of critical importance.~      Aims:~      Does add-on NAC treatment in early psychosis influence:~        -  positive and negative symptoms~        -  extrapyramidal side-effects of other medication~        -  plasma concentration of glutathione~        -  Mismatch Negativity, a physiological marker~   "
130033|NCT01353391|"~     Insulin is the standard treatment for the management of type 2 diabetes in pregnancy,~     however despite treatment with insulin, these women continue to face increased rates of~     adverse maternal and fetal outcomes. The investigators hypothesize that metformin use, in~     addition to treatment with insulin, will help with blood sugar control, lower the dose of~     insulin needed, lower weight gain, and improve baby outcomes.~   "
129953|NCT01354548|"~     Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific~     areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and~     general mouth hygiene, which all have negative effects on quality of life. Research in the~     area of trismus is limited; it is not known exactly when trismus develops, one study~     suggests that some patients have experienced a diminished opening at as low doses as 15 Gy.~     Literature suggests benefits of a training programme, but there is a lack of evidence to~     support the use of a training programme during radiotherapy.~      The purpose of this study is to investigate the effectiveness of a training programme during~     and after radiotherapy, and report the incidence of trismus in patients who receive~     radiotherapy to the jaw muscles. The study also investigates quality of life during~     radiotherapy and up to one year after completed treatment.~      Patients who meet the criteria and give their consensus to the study are divided into two~     groups:~      Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable~     system utilizing repetitive passive motion and stretching to restore mobility and~     flexibility of the jaw musculature. Individuals train five times a day.~      Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw~     mobility decreases 15% from the original start measurement, the patient is automatically~     offered a trainings program (as in group 1).~      During radiation therapy a hospital specialist dentist measures the jaw mobility once a~     week, thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different~     occasions the patients are requested to complete a Quality of life questionnaire. Patient's~     record their training frequency in a log book.~   "
129954|NCT01354535|"~     The purpose of this study is to compare two different but standard treatments for the~     fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction~     internal fixation using a locked plating system versus plating and strut allograft with~     cerclage wiring to determine which treatment results in a faster return to function as~     measured by the TUG test at 6 weeks post-op.~   "
129955|NCT01354522|"~     Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative~     breast cancer, while capecitabine is more effective in this group of patients.~      This is a prospective, randomised phase III trial, to compare the efficacy and safety~     profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive~     breast cancer patients.~      Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental~     Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with~     capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest~     period.~      Women with hormone receptor positive tumours must receive 5 years endocrine after the end of~     chemotherapy.~      Patients may receive radiotherapy when clinically indicated.~   "
129956|NCT01354509|"~     Comparison between a normothermia protocol and current protocol (acetaminophen plus~     blankets)~        1. Normothermia Protocol is successful in achieving and maintaining normal temperature in~          moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs~          from admission to Neuro ICU)~        2. Normothermia is translated into improved neurologic Outcome and survival compared to~          standard of care (Physician management)~   "
129957|NCT01354496|"~     The purposes of this study are to compare how much of LY2409021 enters the bloodstream and~     how long the body takes to get rid of the drug when different formulations of LY2409021 are~     given, and when LY2409021 is taken with or without food.~      The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting~     of 3 formulations of LY2409021. Subjects in each cohort will receive the same all 3~     formulations using a randomized sequence crossover design. There is a washout period of at~     least 14 days between dosing periods.~      There will be an interim analysis after Cohort 1 completes study period 2. Cohort 2 will not~     begin enrolling until this analysis is complete. The need to enroll cohort 2 will be~     determined by the outcome of the interim analysis.~   "
129958|NCT01354483|"~     The purpose of this study is to investigate the feasibility, safety, efficacy and optimal~     dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal~     cord injuries.~   "
129959|NCT01354470|"~     The proposed study will establish the safety and efficacy of modafinil in the treatment of~     methamphetamine dependence, as well as assess the affects of modafinil on cognitive function~     in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient~     trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or~     placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions.~     This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco,~     CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.~   "
129960|NCT01354457|"~     The purpose of this study is to determine whether fractionated RIT with Epratuzumab and~     radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.~   "
129961|NCT01354444|"~     This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with~     the primary objective being to determine whether carvedilol treatment is associated with~     improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary~     objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this~     dose will be safe and well-tolerated in AD patients. Clinical assessments will be performed~     at baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be~     obtained at baseline and 6 months.~   "
129962|NCT01354431|"~     The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal~     Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response~     relationship exists.~   "
129963|NCT01354418|"~     This study will assess the food-effect bioavailability of an extended release formulation of~     phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl~     product.~   "
129964|NCT01354405|"~     The aim of this study is to determine the effect of Lanreotide on polycystic liver and~     kidneys in patients with autosomal dominant polycystic kidney disease.~   "
129998|NCT01353846|"~     The purpose of this study is to compare the natural cycle (without any medication) with the~     well-established artificial cycle in an egg donation program.~   "
130034|NCT01353378|"~     The purpose of this study is to determine whether dexmedetomidine is effective in the~     treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.~   "
130035|NCT01353365|"~     Acute dyspnea and chest discomfort are common complaints. Distinguishing between the~     entities that may present with such symptoms can be difficult. This project aims to study -~     venous thromboembolism (VTE) - a difficult diagnosis that can easily be missed yet its~     treatment is highly effective.~      VTE represents a spectrum of disease ranging from deep vein thrombosis to pulmonary embolism~     (PE). Early diagnosis of PE is usually based on suspicion raised by clinical symptoms~     combined with a medical history of obvious predisposing factors. However, in around 30% of~     cases PE occurs in the absence of any predisposing factors. Individual clinical signs and~     symptoms are neither sensitive nor specific.~      PE is generally associated with hypoxaemia, but up to 20% of patients with PE have a normal~     arterial oxygen pressure .Classic ECG changes are generally associated with the more severe~     forms of PE.~      Bio-markers such as Plasma D-dimer (DD) have been investigated extensively in recent years.~     It has been shown that a normal DD level renders acute PE or DVT unlikely; on the other hand~     DD is not useful for confirming VTE.~      CT angiography(CTA) has become the method of choice for imaging the pulmonary vasculature~     for suspected PE. Yet as in DD the pre-test probability of PE based on the clinician's~     abilities highly affects the results of the CT.~      While VTE is a fairly common and sometimes lethal condition its diagnosis is difficult and~     based more on clinical hunches than on highly sensitive and specific diagnostic tools. It's~     quite evident that finding a novel, sensitive and even more importantly specific biomarker~     for PE would change the current approach and work-up needed for reaching a diagnosis.~      We propose using serum levels of surfactant associated protein (SAP) as such a bio-marker.~     Surfactant is a unique phospholipoprotein secreted solely by type II alveolar cells in the~     lungs. About 90% of the surfactant structure is composed of phospholipids and the remaining~     10% is composed of specific proteins.~      Working hypothesis and aims: PE causes ischemic damage to lung tissue. Such damage will~     ultimately lead to a rise of serum SPA. The primary objective of this project is to~     ascertain the fact that indeed there is a rise of serum SPA among patients diagnosed with~     PE, what is the time-concentration profile of such rise and is the rise correlated to the~     size of the embolus.~      Methods: The study will be designed as a prospective study consisting of several steps. The~     measurement of serum SPA will be done by commercially available ELISA kits. All patients~     will be enrolled by researchers from both the ER and internal B ward at the Rambam Medical~     Center.~      Probable implications to Medicine: If indeed SPA levels will be proven to be a novel~     bio-marker for PE this could ultimately lead to a totally different approach in the~     classification and treatment of patients presenting with signs that may be associated with~     PE.~   "
129965|NCT01354392|"~     Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a~     type of cancer of a cell called a lymphocyte which makes up part of the immune system.~     Although most patients are cured with chemotherapy used as initial treatment, about 20-30%~     of patients still experience relapse. Curing relapsed disease is much less successful, even~     with the use of high doses of chemotherapy and stem cell transplant. There is then an urgent~     need for effective, new agents to treat patients with diffuse large B-cell lymphoma who have~     relapsed or who have developed resistance to other forms of chemotherapy.~      This trial is using a drug called AZD1152 which interferes with the ability of a cancer cell~     to divide and grow. It has been used before in patients with other types of cancer, but~     never before in lymphoma patients. Responses in other cancers have been seen, particularly~     in leukaemia which is a disease related to lymphoma. The investigators are planning to use~     this agent in 15 patients with diffuse large B-cell lymphoma in which potentially curative~     treatments have failed. The main aim is to see whether the drug shows any activity in this~     type of lymphoma. This will be mainly assessed using CT and PET scans. The investigators are~     also investigating how well a blood test can predict both the response to the drug and the~     toxicity of the drug - this is called a biomarker study and forms part of the clinical~     trial. The other main aim of the study is to assess the toxicity of the treatment. Previous~     studies in humans suggest the drug is reasonably well tolerated, although side effects such~     as stomatitis (soreness of the mouth) and suppression of the bone marrow (leading to risk of~     infection and bleeding) have been seen.~   "
129966|NCT01354379|"~     The purpose of this study is to test the safety and immune response of a new intranasal~     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine~     that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps~     a vaccine work better), called W805EC. In a prior clinical study this vaccine showed~     promising results in terms of being well tolerated and eliciting mucosal and systemic immune~     responses after administration by a dropper. In this study NB-1008 is being administered by~     dropper as well as a nasal sprayer to determine if the sprayer further enhances the immune~     response.~   "
129967|NCT01354366|"~     This clinical trial will evaluate two investigational hypoallergenic infant formulas with a~     differing protein content to determine if they provide normal growth and are well tolerated~     by term infants as compared to a marketed hypoallergenic formula.~   "
129968|NCT01354353|"~     This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety~     and tolerability of LY2140023 given at doses expected to reflect multiples of the~     anticipated therapeutic exposure under clinical investigation. In the event of poor~     tolerability in part A of this study part B may be conducted to explore higher doses using~     titration. Subjects in both parts A and B will participate in a 9 day wash-out period of~     current medication (Study days 1-9); subjects coming into the study on aripiprazole will~     remain on their current therapy throughout.~   "
129969|NCT01354223|"~     This study seeks to evaluate a new daily disposable contact lens compared to an existing~     daily disposable contact lens.~   "
129970|NCT01354210|"~     The purpose of the proposed study is to test SMS (short message service) text messaging~     technology to improve medication adherence among youth living with HIV (YLH). The proposed~     study is a randomized controlled trial of the effect of text message reminders on ART~     (anti-retroviral therapy) adherence among non-adherent YLH. Daily text message reminders~     will be sent to patients randomized to the intervention group according to their medication~     schedule, for 6 months. The investigators will enroll non-adherent YLH, ages 16-29. Half of~     the sample, randomized to the intervention, will receive daily SMS text message medication~     reminders and half will be randomized to the control condition and receive standard of care~     (SOC) only. For the controlled trial, adherence levels and viral load will be collected at~     baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month~     enrollment period, participants in the control condition will cross-over to the SMS~     intervention and participants in the intervention condition will cease to receive the SMS~     intervention. Adherence and viral load data will be collected from each group at 9- and~     12-month follow-up points. The investigators hypothesize that youth in the intervention~     condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months~     post-baseline, from approximately 70% to 90% adherence to ART.~   "
129971|NCT01354197|"~     -  Overall treatment outcomes of University base SICU~        -  Incidence of adverse events in SICU~        -  Factor associated to adverse events in SICU~   "
129972|NCT01354184|"~     This is an investigation of the efficacy and safety of CRD007 compared to placebo in the~     treatment of patients with abdominal aortic aneurysm.~   "
129973|NCT01354171|"~     This is a multi-centre, prospective, randomized phase III trial to determine if~     multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible~     for active surveillance through better detection of clinically significant cancer.~   "
129974|NCT01354158|"~     The investigators seek to determine the efficacy, duration of action and safety of~     escalating dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive~     hormones and catecholamines during upright seated posture.~      Primary Question:~      1. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and~     105±5 mmHg in women?~        -  When does the defined increase in SBP occur after oral ingestion of droxidopa?~        -  How long does this dose of droxidopa sustain SBP at these levels?~        -  What are the vital signs and the subjective symptomology following droxidopa~          administration?~      Secondary Question:~      1. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?~        -  Does an increase in SBP correspond to an increase in MCA MFV?~      Tertiary Question:~      1. What is the vasoactive hormone and catecholamine response to droxidopa administration in~     hypotensive individuals with SCI?~        -  Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive~          individuals with SCI?~   "
129975|NCT01354145|"~     The main purpose of this study is to compare the cartilage volume loss at the Baseline visit~     and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN)~     1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.~   "
130010|NCT01353690|"~     The aim of this clinical study is to investigate the safety and feasibility of Autologous~     Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for~     patients with advanced heart failure caused by ischemia.~   "
129977|NCT01354119|"~     Background: Aortic stent-graft is useful to occlude intimal tear and prevent further~     dilatation of the false lumen in patients with aortic dissection. The long-term benefit of~     aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well~     demonstrated, especially in patients at high risk of aneurysmal change and death.~      Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft~     insertion performed just after the acute phase into the descending thoracic aorta in~     patients with distal aortic dissection and at high risk of aneurysmal change of the~     dissected aorta.~   "
129978|NCT01354106|"~     The objective of this study is to determine the relative gentleness of two tapes recognized~     for gentleness. A three-prong multidimensional evaluation consisting of laboratory~     assessments, expert skin grader and subject discomfort assessment will be used.~   "
129979|NCT01354093|"~     Macular telangiectasia type 2 (MacTel Type 2) is an uncommon eye disorder that results in~     slow vision loss beginning in middle age. The macula is the central part of the retina,~     which lines the back of the eye like the film of a camera. The macula is responsible for~     central or reading vision. Telangiectasis refers to dilated, leaky vessels, for example~     varicose veins in the legs. One of the earliest manifestations of macular telangiectasia~     type 2 is an acquired reduction and/or redistribution of the macular pigment carotenoids at~     the foveal center. Currently, the biochemical mechanisms and clinical significance~     underlying these changes are not known, but it seems likely that better understanding of~     this phenomenon could lead to new interventions against MacTel.~      The objectives of this study are to image the maculas of MacTel subjects using~     two-wavelength autofluorescence imaging and resonance Raman imaging to target the 7-degree~     radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further~     insight into the significance of this early clinical sign, and to evaluate whether~     supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel~     subjects~   "
129980|NCT01354080|"~     The purpose of this study is to compare the effectiveness of massage based on the tensegrity~     rule and classical abdominal massage in persons with constipation.~   "
129981|NCT01354067|"~     The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients~     resulting in increased dyspnea during physical activity restricts many COPD patients ability~     to perform exercises in general and whole-body exercises in particular. Single limb training~     performed as one-legged cycling has been shown effective in patients with COPD. This~     exercise regime results in less stress on the ventilatory system as training is executed~     using a simultaneously smaller muscle mass. However, the positive physiological effects of~     exercise training only occur in the involved muscle(s). To be of benefit for patients daily~     life, all relevant muscles should be included in exercise training. The aim of the current~     randomized controlled multicenter trial (RCT) is to determine the effects of high-repetitive~     single limb exercises (HRSLE) in combination with COPD specific patient education, compared~     to the COPD specific patient education alone in patients with moderate to very severe (stage~     II-IV) COPD.~   "
129982|NCT01354054|"~     TENS is a non pharmacological intervention to control pain. Both high (>50 Hz) and low (<10~     Hz) frequency TENS are used in the clinic and it is thought that each type works through~     different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased~     response to a noxious stimuli, is one component of pain and occurs both at the site of~     injury, primary hyperalgesia, and outside the site of injury, secondary hyperalgesia. Recent~     studies in animals with arthritis of the knee show that low and high frequency TENS~     differentially modulate primary and secondary hyperalgesia.~      Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with~     movement resulting in increased function.~   "
129983|NCT01354041|"~     The primary objective of this pilot study is to examine the feasibility and acceptability of~     a randomized, controlled study of a mindfulness and values-based living intervention~     targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as~     usual control. Furthermore, the secondary objective of this randomized, controlled pilot~     study is to determine preliminary efficacy and effect size of the mindfulness and~     values-based living intervention compared to the treatment as usual control condition in~     reducing fear of recurrence in breast cancer survivors.~   "
129984|NCT01354028|"~     Premature infants sometimes require sedation to ensure minimal movement during diagnostic~     procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this~     two-day study is to determine whether massage therapy will promote sleep in preterm infants~     and also help them to stay asleep, providing a safer way to sedate infants for procedures. A~     small instrument called a sleep watch or actigraph will be placed around the infant's ankle~     to measure muscle activity and provide an indication of sleep. Infants will receive a 10-~     minute massage on one morning of the study and no massage on the alternate morning.~     Recordings from the actigraph will show whether there is difference in sleep pattern with~     and without massage. Infants will be monitored for any heart rate and oxygen saturation~     changes on both mornings of the study.~   "
129985|NCT01354015|"~     DRMS is a system that communicates with patients via text message using cellphones,~     computers and other devices. It reminds patients about multiple health care and disease~     related issues such as to test their blood sugars and send the result back to the system via~     text message. The system will then decided based on automated algorithms whether to send~     another message advising patients on changing their medication etc.~      This pilot will enroll 100 injectible insulin dependent patients with uncomplicated Type 1~     and Type 2 diabetes mellitus, using insulin, who will be enrolled to participate in the~     pilot. Patients will be randomized 1:1 to either DRMS or standard care. The patients in the~     DRMS program will undergo interactions with the system using multiple communications~     channels including cell phones, IVR, email, web and SMS messaging. The goals of the~     interactive programs are the following:~        1. Monitor and intervene to remind patients to fill their prescriptions~        2. Monitor and track insulin unit consumption utilization and timing of that dosage~        3. Monitor and intervene when the patient does not use or take their medications as~          prescribed.~        4. Monitor and track insulin unit consumption and timing of that dosage~        5. Ask the patient for their glucose levels and then provide customized information to the~          patients regarding how to modify their medication to achieve the desired glucose level~        6. Deliver automated dose adjustment directions based on the providers instructions~        7. Coordinate personalized educational programs and messages into the automated~          intervention programs~        8. Provide feedback to the patients, including performance and reinforcement to both~          providers and to patients.~        9. Provide feedback to providers on patients performance as well as exception based~          reporting~      The System will manage interventions in an automated fashion. Providers will intervene on an~     exception basis and only when automated interventions have not worked or the protocol~     requires immediate action by the provider. For example, if the glucose exceeds certain~     danger levels, as defined by the provider, a requirement might be to call and notify the~     doctor immediately.~   "
130011|NCT01353677|"~     This is a multi-institution, non-randomized, prospective pilot study to evaluate the~     feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and~     adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.~   "
129986|NCT01354002|"~     The aims of this protocol are: to collect and store diseased and normal tissue and body~     fluid samples from new and returning patients at St. Jude Children's Research Hospital~     (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from~     relatives of SJCRH patients; to collect and store retrospective and prospective pertinent~     corresponding clinical and laboratory data on disease characterization, treatment, and~     outcome; and to serve as a source of human biological samples and corresponding laboratory~     and clinical data.~   "
129987|NCT01353989|"~     A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A~     IgG positivity is declining in the Netherlands, also in the elderly. Studies show that~     people above 40 years of age have a slower immune response to hepatitis A vaccination.~     However, a lot of travelers seek pre-travel advice only shortly before their journey. More~     information about the time to adequate antibody response after hepatitis A vaccination is~     required to provide good protection during travelling. Alternative protection with~     immunoglobulins are available.~      Study design: Observational, longitudinal pilot study Study population: 20 adults over 60~     years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis~     A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as~     controls.~      Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent~     is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.~      Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of~     the burden and risks associated with participation, benefit and group relatedness: hepatitis~     A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml~     of blood.~   "
129988|NCT01353976|"~     This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam~     vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is~     a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.~   "
129989|NCT01353963|"~     This is a non-interventional study to review safety data on administration of desvenlafaxine~     succinate among Filipino patients with MDD and VMS per usual clinical practice within the~     first three years post commercial distribution.~   "
129990|NCT01353950|"~     The purpose of this study is to investigate the expression of a certain class of molecules,~     called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic~     disorder which renders the lung susceptible to persistent inflammation which, at times, can~     worsen, resulting in accelerated decline in lung function and eventually death or~     transplant. Our goal is to determine if the levels of costimulatory markers can be used to~     predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.~   "
129991|NCT01353937|"~     Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations~     annually in the US, are a significant burden to our health system, costing more than a~     billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and~     Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells)~     from the bone marrow and traffic them toward the wound, increasing the blood supply that~     subsequently improves wound healing. Because we are using the human body's own resources to~     regenerate itself by targeting and correcting the underlying pathophysiology, we believe~     that this novel therapy yields great promise in the treatment of diabetic foot ulcers.~   "
129992|NCT01353924|"~     The only disease-modifying treatment for allergic disorders nowadays is allergen-specific~     immunotherapy (SIT). To induce hyporesponsiveness increasing doses of the disease-eliciting~     allergens are applied. One major problem of this treatment is, that it has to combat with an~     already established immune response against the disease-eliciting allergen. To circumvent~     this problem the investigators want to perform the proof of principle study towards~     prophylactic treatment. Prophylactic vaccination is used since many years for many~     infectious diseases. The investigators want to adopt this successful principle for the~     treatment of type I allergies.~      For this purpose non-allergic healthy individuals will be immunized with adjuvant-bound~     hypoallergenic derivatives of the major birch pollen allergen, Bet v 1. As usual for~     allergen-specific immunotherapy, injections will be applied subcutaneously. Three injections~     in one-monthly intervals will be given to establish the immune response and a further~     injection after one year will determine how the vaccine-induced immune response can be~     boosted.~      The vaccine will be composed of an equimolar mixture of two adjuvant-bound hypoallergenic~     derivatives of the major birch pollen allergen, Bet v 1. The first investigational product~     (IP) designated as Bet v 1aF1 is a protein of 73 amino acid residues and represents the~     first half (1-73aa) of the Bet v 1 molecule. The second IP, Bet v 1aF2, is a protein of 86~     amino acid residues and represents the second half (74-160aa) of Bet v 1. Both proteins are~     expressed in Escherichia coli. The hypoallergenic derivatives lost their IgE binding~     capacities by the disruption of the conformational IgE epitopes of the Bet v 1 molecule.~      In several preclinical and clinical studies it has been shown that the two hypoallergenic~     fragments, Bet v 1aF1 and Bet v 1aF2 have a strongly reduced allergenic reactivity and~     almost no sensitization potential, requisite for a prophylactic treatment. In a multi-centre~     placebo-controlled double blind clinical trial including 124 allergic patients no relevant~     sensitization against new epitopes could be observed after vaccination of the Alum-bound Bet~     v 1 derivatives.~      In contrast, the vaccine induced a strong IgG response in animals as well as in clinical~     studies. Vaccine-induced antibodies showed protective properties as they could inhibit the~     binding of allergic patients' IgE. An improvement of clinical symptoms and a reduction of~     the skin reactivity was correlated with an increase of IgG antibodies and could be shown~     only in actively treated patients in a multi-centre placebo-controlled double blind clinical~     trial.~      The investigational products will be tested in a Phase I clinical trial for prophylactic~     allergy vaccination in healthy non-allergic subjects. The two IPs will be coupled either to~     Alum and an equimolar mixture will be injected subcutaneously. The immune responses will be~     compared to placebo. In total 20 non-allergic healthy male subjects (10 per group) will be~     included in this clinical trial. For safety precautions the subjects will be monitored by~     skin prick testing using the two uncoupled IPs and commercial birch pollen extract in short~     intervals to recognize possible vaccine-induced sensitizations. The primary endpoint of~     phase I clinical trial is the evolution of Bet v 1-specific and Bet v 1 fragment-specific~     IgG1-4, IgE and IgM antibody levels in serum and in nasal fluids after vaccination of rBet v~     1 derivatives.~   "
129993|NCT01353911|"~     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir~     (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and~     ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.~   "
129994|NCT01353898|"~     This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants~     will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice~     per day) or placebo. Part II will begin after the results of Part I are known; participants~     will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The~     primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1~     infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.~   "
129995|NCT01353885|"~     Osteoarthritis disables approximately 10% of people who are 60 years or older and~     compromises the quality of life of more than 20 million Americans every year. Osteoarthritis~     is caused by the breakdown of cartilage that lines the bones at your joints from daily wear~     and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total~     hip replacement, is currently one of the most successful and cost-effective treatments used~     to eliminate pain and restore function in those suffering from osteoarthritis. There are~     multiple ways to perform a THA. The main difference between each type is the point of~     incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The~     incision performed can be anterior (in front of the muscle), anterolateral (in front and to~     the side of the muscle), or posterior (from the back). Each of these approaches has its own~     advantages and disadvantages, but there is no evidence available that makes one better than~     the other. The purpose of this study is to determine which of the three approaches to THA is~     the most effective. The main outcome that will determine the most effective approach is the~     functional ability of the patients included in this study at 52 weeks. The investigators~     will also compare whether the patient's: length of hospital stay, use of assistive devices,~     need for revision surgery, ability to return to work, ability to relieve pain, complication~     rate, and quality of life. The investigators hypothesize that the anterior approach will be~     the most effective approach in reducing the rate of post-operative complications after THA.~   "
129996|NCT01353872|"~     The main objective of this study is to investigate the effects of ingestion of different~     sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis~     tournament simulation.~   "
129997|NCT01353859|"~     This multicenter, open-label, single arm study will assess the safety and efficacy of~     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active~     rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying~     antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously~     every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly.~     Anticipated time on study treatment is 24 weeks.~   "
129999|NCT01353833|"~     IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to~     control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The~     investigators recently showed that low dose IL-2 is well tolerated in patients with an~     autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D~     patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg~     induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg~     induction, the investigators aim to protect the remaining/regenerating β-cells from~     autoimmune destruction, thus improving or even curing T1D.~   "
130000|NCT01353820|"~     The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis~     (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol~     concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus~     control product.~   "
130001|NCT01353807|"~     The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of~     long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant~     women, while they were in gestational week 30, were randomized to fish oil supplements~     providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no~     supplements; they were asked to take the supplements until delivery. Health outcomes were~     assessed during pregnancy and delivery. Further, offspring health and development has been~     examined during the ensuring two decades by making linkages to the rich Danish health and~     administrative registries, by asking the offspring to complete web-based questionnaires, and~     by examining the offspring physically.~   "
130002|NCT01353794|"~     The objective of this Non-Interventional study is to evaluate the effectiveness & safety of~     Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment~     conditions based on age of the patient (older (age >70 years) and younger patients (age <70~     years). Specifically investigated are the tumor status, duration of Nexavar ® treatment~     (number of cycles) and incidence of Hand foot Skin Reaction.~   "
130003|NCT01353781|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing~     schedules in Japanese patients with advanced solid malignancies.~   "
130004|NCT01353768|"~     GSK is conducting a global retrospective chart review of patients treated with zanamivir as~     part of the Compassionate Use Program (CUP), in an effort to collect as much information as~     possible on the use of this investigational drug. The retrospective chart review is intended~     to gain a better understanding of the safety profile of investigational zanamivir and of~     clinical outcomes in the large number of patients treated outside of a clinical trial~     setting.~   "
130005|NCT01353755|"~     To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail~     of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with~     rhinoconjunctivitis caused by grass pollen with/without controlled asthma.~   "
130006|NCT01353742|"~     This is a phase I study being conducted to support the clinical development program of a FDC~     product of the nucleoside analogue lamivudine and the nucleotide analogue adefovir~     dipivoxil. To establish bioequivalence, the exposure of lamivudine and adefovir dipivoxil~     when administered as the FDC will be compared to that of Heptodin (lamivudine) and Hepsera~     (adefovir dipivoxil) when administered separately. In this study, the FDC product will~     contain 100mg lamivudine/10mg adefovir dipivoxil.~      Total 40 healthy adult subjects will be enrolled. The study will include a screening visit~     and two treatment sessions. The screening visit will be conducted up to 3 weeks prior to the~     first dose of Session 1. All subjects will receive Regimen A through B according to the~     randomization schedule. Eligible subjects will be enrolled in the study and randomized to~     receive the following treatment regimens in table below in one of the following treatment~     sequences: AB, or BA. There will be a seven to ten days washout period between each~     treatment session. Pharmacokinetic sampling for measurement of plasma lamivudine and~     adefovir dipivoxil concentrations will be conducted over a 48-hour period following the~     morning administration of study medication in each study session. During this time, all~     subjects will remain in the unit for pharmacokinetic (PK) sample collection. The total~     duration (from screening to the end of the study) of each subject's participation will be~     approximately four weeks.~   "
130007|NCT01353729|"~     Approximately 40 healthy subjects will be enrolled. Each subject will participate in the~     study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day~     washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each~     dosing period and will remain in the unit until Day 2. Each subject will receive a single~     dose of each of the four treatments on Day 1 of each treatment period in a randomized~     fashion. Subjects will be discharged from the clinical research unit after the completion of~     all assessments on Day 2 of each period and return approximately 5-7 days later for the next~     dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following~     each treatment.~   "
130008|NCT01353716|"~     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment~     of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of~     Shionogi-ViiV Healthcare LLC. DTG is metabolized primarily by uridine diphosphate~     glucuronyltransferase (UGT)1A1, with a minor role of cytochrome P450 (CYP)3A, and with renal~     elimination of unchanged drug being extremely low (< 1% of the dose). Fifty-three percent of~     the total oral dose is excreted unchanged in the feces but it is unknown if all or part of~     this is due to unabsorbed drug or some percentage of biliary excretion of the glucuronide~     conjugate which can be further degraded to form the parent compound in the gut lumen. The~     current Food and Drug Administration (FDA) draft guidance for renal impairment studies~     states that a pharmacokinetic (PK) study in patients with renal impairment should be~     conducted even for those drugs primarily metabolized or secreted in bile, because renal~     impairment can inhibit some pathways of hepatic and gut drug metabolism and transport.~      This study is planned as an open label, single-dose, pharmacokinetic study to evaluate~     plasma DTG pharmacokinetics following oral administration to subjects with severe renal~     impairment (creatinine clearance < 30 ml/min) and matched healthy controls. Results from~     this study are expected to enable the development of appropriate dosing recommendations in~     patients with renal impairment.~   "
130009|NCT01353703|"~     This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when~     administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks~     or a 2-4-6 months schedule.~   "
130013|NCT01353651|"~     Even though the indication for endovascular therapy has been enlarged, open repair of common~     femoral artery is still considered as the treatment of choice. A recent pilot study showed~     that endovascular repair of the CFA seems to be a safe technique of revascularization with~     acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in~     press). TECCO, a French randomized and controlled trial, has been set up to compare open and~     endovascular procedures for the treatment of CFA atherosclerotic lesions.~   "
130014|NCT01353638|"~     Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in~     patients suffering from end stage renal disease.~      However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the~     peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current~     glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products~     (GDP).~      Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock~     reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells~     against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors~     of the cellular stress response - the adequate HRS rather seems to be blocked.~      Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage~     and organ failure and improve the survival of organisms.~      Preclinical results demonstrated that supplementation of PDF with pharmacological doses of~     alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells~     in in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD.~      After these positive preclinical results, this study shall now clarify, whether the addition~     of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable.~     Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will~     be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics~     and the presence/absence/severity of side effects.~   "
130015|NCT01353625|"~     The main purpose of this first human study with CC-115 is to assess the safety and action of~     a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with~     advanced tumors unresponsive to standard therapies and to determine the appropriate dose and~     tumor types for later-stage clinical trials. The bioavailability of tablet and capsule~     formulations under fasting and fed conditions will also be evaluated in some patients.~   "
130016|NCT01353612|"~     This is a prospective, multi-center imaging study expecting to enroll approximately 1350~     patients scheduled for clinically-indicated coronary angiography. Following informed~     consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and~     non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up~     period, patients will undergo repeat coronary IVUS and standard invasive coronary~     angiography as well as carotid ultrasound examination.~      Additionally, patients will be contacted by phone on an annual basis for 5 years to collect~     cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be~     made using invasive and non invasive imaging tools in order to assess correlations between~     vascular beds, imaging technologies and main cardiovascular events.~   "
130017|NCT01353599|"~     Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due~     to complete or partial loss of respiratory muscle innervation which is dependent upon the~     level and completeness of injury [2]. In addition, they share many aspects of obstructive~     airway physiology commonly associated with asthma. In asthma, physiological responses such~     as decrease in baseline airway caliber, bronchodilatation following inhalation of a~     beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely~     related to airway inflammation. The cause of such inflammation is unclear, and may be~     multi-factorial and attributable to: recurrent respiratory infections due to inability to~     effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional~     sympathetic innervation to the airways. Therefore, the investigators propose to test for the~     possible involvement the above mechanisms by pharmacological intervention, and to study~     effects of such intervention on overall pulmonary function and indirect measures of~     pulmonary inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory~     biomarker profile, pulmonary function tests, and cellular profile of the induced sputum.~   "
130018|NCT01353586|"~     The purpose of this study is to assess the safety and effectiveness of the Circular and~     Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated~     Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic~     paroxysmal atrial fibrillation (PAF).~   "
130019|NCT01353573|"~     Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple~     cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear~     accelerator. The treatment of brain metastases represents the most common indication for~     radiosurgery while new indications for this technology are continually being discovered.~     With the increasing importance of radiosurgery and the resource implications for~     radiotherapy programs the investigators have proposed the first direct technological~     comparison of robotic to linear accelerator radiosurgery for brain metastases.~   "
130020|NCT01353560|"~     Despite widespread and growing popularity of complementary and alternative medicine (CAM) in~     the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical~     effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the~     Harvard Medical School (HMS) Osher Research Center established and trained a~     multidisciplinary integrative team of CAM and conventional providers to work collaboratively~     to provide state-of-the-art integrative care in a coordinated and individualized fashion.~     The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within~     the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street~     in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making~     process of both patients and conventional providers with respect to communication about and~     referral to an integrative care team in an academic hospital outpatient setting.~   "
130051|NCT01353157|"~     Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations,~     associated with a systemic inflammatory response syndrome. The aim of this study is to~     assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for~     predicting systemic inflammation. This correlation might identify peri-operative clinical~     outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical~     patients.~   "
130021|NCT01353547|"~     The purpose of the research study is to identify the genetic, environmental and immune~     profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS~     is not a disease caused by a single variation in genetic material (DNA), a single~     environmental factor, or a single malfunction in immune cells, there are genetic~     alterations, environmental exposures and immunologic factors that make the development of MS~     more likely. Obtaining information about who is at risk for MS will be beneficial in the~     future if the investigators can identify effective ways to prevent or slow down the~     progression of this disease.~   "
130022|NCT01353534|"~     Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg~     A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will~     receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered~     IM but followed by the topical application of a VEP at the vaccination site. Group 4 will~     receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application~     of a VEP at the vaccination site.~      The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)~   "
130023|NCT01353521|"~     Complex renal cysts are often incidentally detected on imaging. The differential diagnosis~     of the complex renal cyst includes various benign cystic lesions, which are based on the~     Bosniak classification scheme. Currently the standard of care in evaluating a complex renal~     cyst is using a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced~     magnetic resonance imaging (MRI) scan. Since both of these modalities present adverse events~     due to frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound~     (CEUS) can be used to obtain the same results, without having to impose high doses of~     radiation upon a patient.~   "
130024|NCT01353508|"~     Assess mechanism of action of LCZ696 related to sodium excretion.~   "
130025|NCT01353495|"~     Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM)~     in 12 weeks.~   "
130026|NCT01353482|"~     Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of~     two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the~     abdomen). Cancer affecting the pleura is the more common of these and is called Pleural~     Mesothelioma. This is most commonly caused by exposure to asbestos.~      Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is~     based around controlling the disease and managing the symptoms, rather than curing the~     disease.~      The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two~     anticancer drugs; Pemetrexed and Cisplatin.~      The trial will look into whether there are benefits of adding a third drug called Vorinostat~     to the treatment.~   "
130027|NCT01353469|"~     Primary Objective:~      To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a~     24-week treatment period in patients with type 2 diabetes mellitus.~      Secondary Objectives:~        -  To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2~          diabetes mellitus on fasting plasma glucose (FPG)~        -  To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in~          patients with type 2 diabetes mellitus~   "
130028|NCT01353456|"~     Recently, multimodal approach for postoperative pain control has been advocated.Combinations~     of traditional and novel pharmacological agents are administered, aiming to improve~     analgesia, spare opioid consumption, minimise adverse effects, and improve postoperative~     bowel function in colorectal surgery.~      One of the novel agents suggested is dexmedetomidine. It is a selective alpha-2 adrenoceptor~     agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing~     effects. Furthermore, a significant reduction in postoperative morphine consumption by using~     patient-controlled analgesia (PCA) has been achieved when dexmedetomidine was administered~     before operation. The drug also reduces cate-cholamine secretion, thereby reducing stress~     and leading to a modest reduction in heart rate and blood pressure, which may be~     particularly beneficial in patients with cardiovascular disease, while respiratory rate is~     not affected.~      In this study, the investigators would like to evaluate the analgesic effects of~     dexmedetomidine, which is administered intraoperatively with morphine, followed by~     postoperative PCA morphine infusion, for postoperative pain for open and laparoscopic~     colorectal surgery. Cyclooxy-genase-2 (COX-2) inhibitors and rescue intramuscular pethidine~     will also be incorporated as part of the multimodal analgesia regimens.~      Good pain control can help to decrease cardiovascular complications. Emerging data has~     suggested a key role of soluble CD40L as inflammatory mediators of atherosclerotic lesion~     progression. The investigators would like to evaluate the effect of our analgesic regimens~     on soluble CD40L peri-operatively.~      The investigators hypothesize that intraoperative dexmedetomidine can reduce postoperative~     pain and improve recovery and outcomes.~   "
130029|NCT01353443|"~     AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with~     patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.~      The primary objective of the clinical investigation is to test the hypothesis that insertion~     of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized,~     polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will~     reduce the hernia formation rate within the first 2 years.~      A reduction from 30% to 10% of the patient population is assumed.~   "
130030|NCT01353430|"~     The investigators are researching families with inherited inclusion body myopathy (IBM)~     and/or Paget disease of bone (PDB) and/or dementia (FTD) which is also called IBMPFD. IBMPFD~     is caused by mutations in the VCP gene. Our main goal is to understand how changes in the~     VCP gene cause the muscle, bone and cognitive problems associated with the disease.~      The investigators are collecting biological specimen such as blood and urine samples, family~     and medical histories, questionnaire data of patients with a personal or family history of~     VCP associated disease. Participants do not need to have all symptoms listed above in order~     to qualify. A select group of participants may be invited to travel to University of~     California, Irvine for a two day program of local procedures such as an MRI and bone scan.~      Samples are coded to maintain confidentiality. Travel is not necessary except for families~     invited for additional testing.~   "
130031|NCT01353417|"~     This non-interventional study intends to collect epidemiological data in patients with~     stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according~     to the approved indication.~   "
130052|NCT01353144|"~     Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of~     aspirin-related peptic ulcers.~   "
130036|NCT01353352|"~     Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases~     being seen annually in U.S. and Canadian EDs. While the majority of these cases represent~     soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and~     approximately 10,000 suffer spinal cord injury. There are no readily available national~     Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory~     Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably~     estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures~     suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only~     0.9% of these patients are found to have cervical spine fractures or dislocations.~   "
130037|NCT01353339|"~     Primary Research Questions:~      Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will~     be assessed.~        1. Under efficacy, this pilot will determine whether levofloxacin can decrease the~          incidence of BK viruria and peak urine BK viral load.~        2. Under safety, this pilot will determine the incidence of adverse events with~          levofloxacin.~        3. Under feasibility, this pilot will determine the number of kidney transplant patients~          randomized over an eight month enrolment period, adherence to the levofloxacin and~          frequency of patient drop-out and loss to follow-up~   "
130038|NCT01353326|"~     The purpose of this study is to compare the bone mineral density of patients who have~     undergone either cemented or cementless hip resurfacing.~   "
130039|NCT01353313|"~     The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course~     of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who~     are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or~     placebo. This study will determine if hydrocortisone improves infants'survival without~     moderate or severe BPD and will be associated with improvement in survival without moderate~     or severe neurodevelopmental impairment at 22 - 26 months corrected age.~   "
130040|NCT01353300|"~     RATIONALE: The identification of gene mutations in young patients with pleuropulmonary~     blastoma syndrome may allow doctors to better understand the genetic processes involved in~     the development of some types of cancer, and may also help doctors identify patients who are~     at risk for cancer.~      PURPOSE: This research study studies gene mutations in samples from young patients with~     pleuropulmonary blastoma syndrome at risk for developing cancer.~   "
130041|NCT01353287|"~     The primary objective of this clinical trial is to evaluate safety of patients who underwent~     Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped~     transmission as compared to those without procedure transmission.~   "
130042|NCT01353274|"~     Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in~     patients with Hypertension~   "
130043|NCT01353261|"~     This study is being done to learn more about platelet reactivity (how well the small cells~     in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for~     stable and unstable (acute myocardial infarction) indications. Stable means you have not~     demonstrated any acute injury to your heart prior to your PCI; unstable means you have~     demonstrated some acute injury to your heart prior to your PCI. The investigators intend to~     determine if there is a change in platelet reactivity from the time of PCI to 30days~     post-PCI and does this change differ depending upon the conduction in which you present for~     PCI. This is going to be done with a variety of platelet reactivity assays.~   "
130044|NCT01353248|"~     The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when~     given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and~     tolerable in the treatment of Chronic Genotype 1 HCV Infection.~   "
130045|NCT01353235|"~     Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on~     therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care~     unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.~      Randomization is stratified according to ventilatory support: non invasive or conventional~     ventilation.The major outcome is the ICU mortality rate in overall population and stratified~     according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).~      Secondary outcomes are superinfection necessitating a new antibiotic course, Length of~     mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency~     of gastric bleeding episodes that of frequency of hyperglycemic episodes.~   "
130046|NCT01353222|"~     This study is being conducted to examine survival, safety, and the magnitude of the immune~     response induced following administration of DN24-02 in subjects with HER2+ urothelial~     carcinoma.~   "
130047|NCT01353209|"~     The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in~     postmenopausal women with Lymphangioleiomyomatosis (LAM) will prevent or delay progression~     of lung disease and result in a decrease in the rate of decline in FEV1~   "
130048|NCT01353196|"~     Carotid artery plaques are known to cause stroke. Cognitive impairment is an insidious but~     poorly understood problem in patients with carotid plaques. Cognitive function describes how~     people perform mental processes such as thinking, learning and problem solving. Asymptomatic~     carotid plaques may affect 1 million Veterans who may be at risk for cognitive impairment.~     In this study, the investigators will uncover the extent of cognitive impairment in Veterans~     with carotid stenosis who are currently labeled asymptomatic. Programs to prevent or~     mitigate cognitive impairment will depend on identifying the mechanisms by which this~     occurs. The investigators will use sophisticated 3D imaging techniques developed by the~     group to measure the structure and composition of plaques, number of particles breaking off~     from them, blood levels of chemicals that could disrupt them, and blood flow restriction to~     the brain from them. This will help identify patients at risk for cognitive impairment who~     may benefit from preventative measures and improve selection of patients to decrease~     unnecessary surgical procedures.~   "
130049|NCT01353183|"~     The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and~     other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy)~     based upon the detection of pathological alpha-synuclein species in routine colonoscopic~     biopsies.~   "
130050|NCT01353170|"~     The study was designed in order to investigate the effects of 3 different dialysate calcium~     concentrations may exert on mineral metabolism and hemodynamic stability in standard~     hemodialysis (hd).~   "
130053|NCT01353131|"~     Prevention of myocardial functional deterioration and sudden cardiac death among individuals~     of intermediate risk remains one of the most elusive frontiers of contemporary medicine.~     While most of these individuals are known to have had contact with the medical system, they~     are frequently not considered to be at high risk until far advanced along one or multiple~     disease processes leading to irreversible myocardial loss and electric instability. The goal~     of this proposal is to determine the prognostic power of combining specific measures of~     ventricular architecture, myocardial structure and electrical function for the early~     identification of individuals at risk to develop ventricular arrhythmias and progressive~     myocardial failure leading to severe cardiovascular outcomes and death.~   "
130054|NCT01353118|"~     Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations~     can cause rapid and uncontrolled reductions in blood glucose. There is limited information~     on whether:~        -  metabolic surgery is superior to modern medical care for glycaemic control and type 2~          diabetes remission.~        -  metabolic surgery is safe for microvascular complications of Type 2 diabetes~        -  good glycaemic control pre surgery has any effects on the long term glycaemia and~          complications of type 2 diabetes.~      This study aims to assess:~        1. whether metabolic surgery is better for diabetes control compared to medical treatment.~        2. whether metabolic surgery is safe for eye, nerve and kidney complications.~        3. whether good sugar control before metabolic surgery improves the long term effects of~          sugar control and microvascular complications.~   "
130055|NCT01353105|"~     Only about 15% of the potential candidates for lung donation are considered suitable for~     transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can~     be used for evaluation and reconditioning of marginal and unacceptable lungs. The ´purpose~     of this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary~     ex vivo in marginal donors.~   "
130056|NCT01353092|"~     In this study patients with treatment resistant depression, as defined by Harold Sackeim, is~     subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment~     (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients~     are randomized into two groups. In group A patients receive active treatment both morning~     and afternoon. In group B patients receive one sham and one active treatment. The study is~     double-blind as neither the assessors or patients are aware of treatment allocation. Each~     session lasts 30 minutes. Patients are psychometrically assessed weekly for depression~     severity and side effect. After this intervention period patients are followed for further~     three weeks without PEMF treatment. Patients are on unchanged medication for the whole of~     the study period.~   "
130057|NCT01353079|"~     The primary objective of this study is to demonstrate that SLIT administered pre-and~     co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short~     ragweed pollen season.~   "
130058|NCT01353066|"~     Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for~     cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV~     risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial~     intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at~     the control of CVRF in T2DM may not translate in the reduction of CV events.~      Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP)~     could be superior in the control of the progression of subclinical atherosclerotic disease,~     as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9~     kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment~     (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the~     carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to~     baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients~   "
130059|NCT01353053|"~     The aim of this the study is to the assess whether the graft and patient survival, rejection~     rates and renal graft function after the first year will not differ between both study arms.~     The investigators will also the evaluate the reduction in the incidence of cytomegalovirus~     the and improvement of renal function of the everolimus after 1 year.~   "
130060|NCT01353040|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg~     virus.~   "
130061|NCT01353027|"~     The purpose of this study is to characterize the safety and pharmacology of single~     administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.~   "
130062|NCT01353014|"~     This study's primary objective is to determine if providing individuals with personal~     genetic information impacts dietary intake behaviour. Specifically, the investigators will~     be examining whether providing dietary advice based on genes that affect the metabolism of~     or sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these~     dietary components. The study hypothesis is that providing dietary advice based on genetics~     will impact dietary behaviour to a greater extent than general dietary recommendations.~   "
130063|NCT01353001|"~     The purpose of this study is to examine the effect of weight loss and exercise on~     cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive~     Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III~     obese women during a 12 week training intervention.~   "
130064|NCT01352988|"~     The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters~     (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of~     responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI)~     activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest~     assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).~   "
130140|NCT01351974|"~     Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure~     in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and~     sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between~     September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel~     Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative~     SLNB for patients in which completion ALND were omitted. The patients were followed~     prospectively and events (local, regional and distant recurrences and deaths) were~     registered. The primary endpoint was axillary recurrence and secondary endpoints were~     disease-free, cancer-specific and overall survival.~   "
130065|NCT01352975|"~     Background:~        -  Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals~          over 55 years of age. It can cause permanent loss of central vision, which is important~          for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD.~          Most people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the~          more serious form and can result in severe vision loss.~        -  A method to identify and monitor the early to middle stages of AMD may help researchers~          develop new treatments to stop the disease before it becomes severe. In early dry AMD,~          people cannot see well at night. Researchers want to study whether a procedure that~          measures how the eye adjusts to the dark can help to identify and monitor early to~          middle dry AMD.~      Objectives:~      - To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor~     early to middle dry age-related macular degeneration.~      Eligibility:~      - People at least 50 years of age who have no AMD. Others who have early to middle dry AMD~     in at least one eye.~      Design:~        -  People will be screened with a physical examination, medical history, blood and urine~          tests, and a full eye exam.~        -  This study will last 5 years and require at least 9 visits to NIH. (First visit; study~          visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits).~        -  Up to 10 people will be asked to come back to the clinic 1 week after their first~          visit. They will be asked to test the device to be used in the study.~        -  Participants will have baseline exams. These questions will be about problems that~          affect their eyes under different lighting conditions.~        -  At every visit, participants will answer questions about general health and current~          medications (including any vitamins or supplements). They will also have a full eye~          exam and a 20- to 40-minute test. This test measures how fast the eyes recover in~          response to decreasing levels of light. The test also measures how sensitive the eyes~          are to these conditions.~        -  Participants will continue to have these tests at the yearly followup examinations.~          They will be treated with the standard of care for any eye conditions they have or may~          develop during the study.~   "
130066|NCT01352962|"~     Background:~      - Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer,~     including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that~     prevents the growth of new blood vessels in tumors, has been approved for treatment of~     certain blood cancers, but it has not yet been approved for use in combination with~     gemcitabine and carboplatin. Researchers are interested in determining the safest and most~     effective dose of this combined form of chemotherapy for solid tumors, particularly for~     urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).~      Objectives:~        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and~          carboplatin as a treatment for solid tumor cancers.~        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and~          carboplatin as a treatment for urothelial (bladder) cancer.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that~          have not responded to standard treatments.~        -  Individuals at least 18 years of age who have been diagnosed with urothelial cancer~          that has not responded to standard treatments.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and tumor imaging studies.~        -  Participants with urothelial cancer will receive lenalidomide alone for the first 14~          days of a 21-day cycle before starting the first full treatment cycle.~        -  All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1~          only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the~          first 14 days of each cycle. Participants will be asked to take aspirin or other~          medications to prevent the possibility of blood clots.~        -  Participants may receive up to six cycles of treatment with this combination. If after~          six cycles the cancer has not grown or has shrunk, participants may continue to take~          lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until~          the cancer recurs.~        -  Participants will be monitored with blood samples, physical examinations, and tumor~          imaging studies through the cycles of treatment.~        -  After the end of the last treatment cycle, participants will have followup visits every~          3 months for the next 18 months, then every 6 months for another 18 months, and then~          yearly....~   "
130067|NCT01352949|"~     Background:~      - Stereophotogrammetry (SP) uses four sets of digital cameras to generate a~     three-dimensional computer image. Unlike other types of evaluations which require radiation,~     SP only uses computer images to learn more about physical deformities such as scoliosis or~     about the placement of fat on the body. To refine the SP process, researchers are interested~     in collecting images and body data from individuals with skeletal structural problems such~     as scoliosis or chest wall deformities, individuals who are overweight or obese, and healthy~     volunteers.~      Objectives:~      - To use stereophotogrammetry to study different individual body types and refine existing~     imaging techniques.~      Eligibility:~      - Individuals at least 2 years of age who have spine, rib, or chest wall deformities; are~     overweight or obese (body mass index greater than 25); or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination and medical history. The~          physical examination will include measurements of range of motion and joint mobility,~          torso width and length, and other observational data.~        -  Healthy volunteers and participants in the obesity group will also have bioelectric~          spectroscopy (bioimpedance), which uses an additional machine to measure how fat is~          spread in different parts of the body.~        -  After the physical examination has been completed, participants will have SP~          photographs taken. Participants will be asked to remove all clothing from the torso,~          stand with arms raised at the center of four cameras, and remain still while several~          images are taken. A complete image takes less than 1 second.~        -  Participants with spine or rib deformities, or who are in the obesity group, may also~          volunteer to return for followup SP imaging, once a year for 5 years, to study progress~          over time.~   "
130068|NCT01352936|"~     Staphylococcus aureus, the most virulent of the many staphylococcal species, has been~     recognized as one of the most important and lethal human bacterial pathogens. With the~     increased incidence of methicillin-resistant staphylococcus aureus (MRSA) infection in~     community and hospitalized patients, MRSA infections are associated with greater lengths of~     stay, higher mortality, and increased costs. Vancomycin and teicoplanin, are the two most~     commonly used glycopeptides and are the first-choice of treatment for MRSA infection.~     Vancomycin-induced nephrotoxicity is still a point of controversy. Teicoplanin is not known~     to have any nephrotoxicity. Acute kidney injury is a common complication of critical~     illness, which is reported in 5 to 7% of hospitalized patients. It is associated with~     significantly increased mortality, length of stay, and costs across a broad spectrum of~     conditions.~   "
130069|NCT01352923|"~     In this study PEAR1 polymorphisms effects will be analyze in blood platelets to determine~     how PEAR1 regulates platelet activation.~   "
130070|NCT01352910|"~     Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy,~     physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always~     satisfactory with persistent symptoms after long-term follow-up. In a preliminary~     retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ±~     16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor~     cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9),~     with an immediate or quasi-immediate recovery in 73% of patients (n=51).~      We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to~     the restoration of an appropriate cerebral connectivity by activating a suppressed motor~     cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.~      A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be~     done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis~     at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be~     performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz)~     with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the~     paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a~     standardized examination), 2- the number and gravity of side effects.~      If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be~     considered a useful early therapeutic option.~   "
130071|NCT01352897|"~     The objective of this follow-up retrospective study is to evaluate the long term efficacy~     and safety of rosuvastatin in reducing lipid parameters in clinical practice.~   "
130072|NCT01352884|"~     This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult~     patients with cancer that is not responding to standard therapy. This study will be~     conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.~   "
131711|NCT01331278|"~     The custom cutting guides personalized for each patient via pre-operative MRI will result in~     significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee~     function, and patient satisfaction.~   "
130073|NCT01352871|"~     The innate immune response is the first line of defense against invading pathogens. Ideally,~     the inflammatory response is tightly regulated leading to both adequate protection to~     invading pathogens as well as limitation of an exuberant or unwanted immune response such as~     seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic~     nervous system (ANS) and the innate immune response are intimately linked. Activation of the~     sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in~     some cases, sympathetic drive can also stimulate the inflammatory response via~     α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response~     as well, since it was discovered that electrical stimulation of the efferent vagus nerve in~     rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure~     autonomic which can not be influenced by behavior. However, trough special~     concentration/mediation techniques mastered by certain individuals, it might be possible to~     modulate ANS activity. In addition, recent unpublished findings indicate that these~     concentration/meditation techniques can also influence the inflammatory response ex vivo.~      In this study the investigators wish to investigate the effect of concentration/meditation~     on the innate immune response in vivo. In addition the investigators wish to elucidate the~     mechanism via which this effect is mediated. The investigators aim to use the so called~     human endotoxemia model. This model permits elucidation of key players in the immune~     response to a gram negative stimulus in vivo, therefore serving as a useful tool to~     investigate potential novel therapeutic strategies in a standardized setting.~      Objectives:~      Primary objective: The primary objective of the study is to determine the effect of~     concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS)~     challenge.~      Secondary Objective(s):~        1. To determine the effects of concentration/meditation on ANS activity.~          Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve~          activity and plasma concentrations of catecholamines will be measured for this purpose.~        2. To determine if concentration/meditation can attenuate (subclinical) renal damage known~          to occur during human endotoxemia, markers of proximal and distal tubular damage will~          be measured at various time points.~   "
130074|NCT01352858|"~     This is a study which will look at safety, feasibility and acceptability of a new therapy~     called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood~     cells, which will be injected into the knee joints of rheumatoid arthritis patients, using a~     procedure called arthroscopy (a camera examination of a joint). The investigators are also~     looking to see if the drug has any effect on the disease activity (if it can help in RA) and~     whether the drug can affect the immune system. The investigators aim to treat 12 patients in~     total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3~     patients per dose. Subjects will have RA and at least one swollen knee joint. They will~     undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee~     aspirated (fluid taken out) and finally undergo a procedure called leukapheresis (removal of~     white blood cells) from which the treatment will be manufactured. Subsequently they will~     undergo 3 arthroscopies (camera examination of the knee joint) over a period of about 12~     weeks. On the first arthroscopy they will have the TolDC injected into their knee joint.~     They will then spend the night at the Clinical Research facility for observation. Over the~     next 5 days they will be telephoned daily by the study doctor to check how they are, and~     will be reassessed if needed. About 2 weeks later they will have their second arthroscopy to~     look for effects of treatment, and the third will take place at 13 weeks (end of study) or~     sooner if the knee appears to get worse.~   "
130075|NCT01352845|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study the immune response elicited by this vaccine when given to healthy young adults. The~     study will also look at the safety of the new vaccine as well as how it is tolerated.~   "
130076|NCT01352832|"~     The investigators propose a two-year group randomized trial of physician practices to test~     the effectiveness of an interactive DVD that presents a culturally appropriate communication~     training program for patients called How To Talk To Your Doctor (and Get Your Doctor to~     Talk to YOU!) in promoting safe prescription and use of Nonsteroidal anti-inflammatory~     drugs (NSAIDs) in the outpatient setting (HTTTYD-NSAIDs).~      The outcome of interest is safer use of NSAIDs as reported by patients. The aims are to:~      Aim 1. Develop an interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs)~     that presents culturally appropriate stories through which a viewer can learn risk factors~     for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs~     with their doctor.~      Aim 2. Conduct a group-randomized trial to test the following three hypotheses about the~     effectiveness of the interactive DVD in promoting safer use of NSAIDs:~      Hypothesis 1: Intervention group patients will be more likely to report that they had a~     conversation with their doctor about safe NSAID use than control group patients.~      Hypothesis 2: Intervention patients will report significantly fewer risky NSAID ingestion~     behaviors (e.g., concomitant use of OTC and prescription NSAIDs) than control patients.~      Hypothesis 3: There will be no difference in the intervention's effectiveness between~     African American and White participants.~   "
130077|NCT01352819|"~     The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an~     adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive~     Parkinson's disease that are not adequately controlled with medication.~      It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation~     system using constant current instead of constant voltage and using a lead with an active~     electrode tip.~   "
130078|NCT01352806|"~     The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are~     not always easy to find, More so, even after correct identification of palpable landmarks,~     Variability exists leading to performing neuraxial injection in undetermined intralaminar~     level. The most accurate method for identifying the interspace is the using of the~     fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical~     in majority of cases. As ultrasound technology becomes more accessible to the clinician, it~     holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist~     in routine cases.~      The aim of this study to compare the accuracy of identifying the intervertebral space,~     between manual palpation, versus ultrasound versus fluoroscopy.~   "
130079|NCT01352793|"~     A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio~     to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group~     will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.~      All subjects will be followed for 6 months after the last vaccination to assess safety and~     tolerability.~   "
130080|NCT01352780|"~     The aim of this study is to evaluate clinical and health economic parameters in relation to~     individual motivational counseling by phone.~   "
130081|NCT01352767|"~     A randomised, controlled, cross-over study with inpatient and outpatient phases. The~     inpatient phase length will be two days, which include a Control day without activating~     the InSuPad and a Test day where the InsuPad is activated. The outpatient phase length is~     8 weeks: 4 weeks without the device-Control, and 4 weeks with the device-Test.~   "
130082|NCT01352754|"~     Background: Patients undergoing hip fracture surgery are elderly and usually have~     co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard~     for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis.~     Perioperative troponin elevation is a poor prognosis factor. The significance of minor~     troponin elevation, detected by highly sensitivity troponin T assay, is unknown.~      Objectives: To determine the frequency of perioperative troponin T elevation using highly~     sensitivity troponin T assay, and to determine the clinical significance of this elevation.~      Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested~     prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay.~      Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated~     troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.~   "
130083|NCT01352741|"~     The main objective of the study is to evaluate the effectiveness, safety, and tolerability~     of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a~     combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects~     requiring additional analgesia after titration to tapentadol PR 300 mg per day.~      This is a clinical effectiveness trial designed to establish a link between anticipated~     clinical outcomes and the clinical practice by means of selected measures of clinical and~     subject reported outcomes. Since, severe low back pain with a neuropathic component, the~     targeted study population, is frequently treated with a combination therapy (monotherapy is~     often not effective enough) it is of interest to determine if tapentadol alone (combining 2~     mechanisms of action in a single molecule) could be as effective as a combination of~     tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus~     combination are of interest.~   "
130084|NCT01352728|"~     The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving~     transarterial chemoembolization is improved with addition of axitinib.~   "
130085|NCT01352715|"~     The study was conducted on people who were taking their first anti-HIV drug regimen~     (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV~     drug) but the drugs in this regimen were not doing a good job of fighting their HIV~     infection.~      The main purpose of this study was to compare two other anti-HIV drug regimens to see how~     well they fight HIV. The study also looked at how well participants tolerate the drug~     regimens and how safe they are.~      The study was designed to determine whether taking the combination of lopinavir/ritonavir~     (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line~     therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase~     inhibitor (NRTI) combination. Testing a regimen that does not include any NRTIs was~     important because NRTIs may no longer work for patients who received them as part of their~     first treatment regimen.~   "
130086|NCT01352702|"~     The aim of this study is to evaluate whether dabigatran reduces clopidogrel mediated ADP~     induced platelet aggregation measured by MEA as compared to phenprocoumon after a two-week~     treatment with either agent.~   "
130087|NCT01352689|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of~     CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
130088|NCT01352676|"~     Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan~     utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million~     per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to~     $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents~     only 11% of radiologic examinations but is responsible for two-thirds of the ionizing~     radiation associated with medical imaging in the U.S. Recent estimates suggest that there~     will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common,~     non-life-threatening condition for which CT is overused. As many as 12% of people will have~     a kidney stone in their lifetime, and more than one million per year will present to the~     emergency department (ED). CT is now a first line test for renal colic, and is very~     accurate. However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT~     rarely alters management. A decision rule is needed to determine which patients with~     suspected renal colic require CT. While the signs and symptoms of renal colic have been~     shown to be predictable, no rule has yet been rigorously derived or validated to guide CT~     imaging in renal colic. A subset of patients with suspected renal colic may have a more~     serious diagnosis or a kidney stone that will require intervention; however the~     investigators maintain that clinical criteria, point of care ultrasound and plain~     radiography (when appropriate), will provide a more comparatively effective and safer~     approach by appropriately limiting imaging.~   "
130089|NCT01352663|"~     This is an open label, randomized, parallel group comparison of the immunogenicity safety of~     Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics~     patients.~   "
130090|NCT01352650|"~     The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell~     derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as~     induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML)~     will improve treatment outcomes via mobilization of leukemia stem cells and alteration of~     the pharmacodynamics of decitabine. The protocol will establish the safety and feasibility~     of combining two different doses of plerixafor with a fixed dose and schedule of decitabine.~   "
130091|NCT01352637|"~     The purpose of this study is to test the differences between four active treatment~     conditions for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality~     exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or~     placebo, as well as to examine predictors for PTSD and response to treatment in active duty~     military personnel, veterans, and civilians who served in Iraq and Afghanistan.~   "
130141|NCT01351961|"~     In the cross sectional study Adelahyde 1 which took place between 2001 and 2005, the~     investigators data suggest that vascular alterations may play a role in the setting of~     subjective memory complaints.~      This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the~     evolution of cognitive function and dementia.~   "
130348|NCT01348295|"~     This observational study includes questionnaires send to doctors in all units treating~     pediatric patients with mechanical ventilation in Finland. Additionally all units treating~     pediatric patients with mechanical ventilation are invited to perform a quality control-like~     follow up for 3 months. Patient identity data is not collected, and no interventions to~     treatment are made.~   "
130092|NCT01352624|"~     Veterans with psychiatric disabilities face unique challenges concerning money management.~     Financial strain, money mismanagement, and homelessness have been well documented among~     veterans with psychiatric disabilities and linked to poor outcomes. The investigators'~     long-term goal is to promote recovery among veterans with psychiatric disabilities by~     addressing an 'unmet need' of developing basic money skills necessary for independent~     functioning in living, working, and social environments. The investigators' objective in the~     current application is to rigorously evaluate a pilot-tested, stakeholder-informed~     intervention grounded in principles of psychiatric rehabilitation designed to help develop~     money management skills and informed financial judgment among veterans with psychiatric~     disabilities. $teps for Achieving Financial Empowerment ($AFE) is an individualized,~     psycho-educational intervention that aims to teach veterans with psychiatric disabilities~     how to save money, create a viable budget, avoid money scams and financial exploitation, and~     access vocational and mental health resources. To evaluate the $AFE, the investigators will~     randomly assign N=200 veterans with psychiatric disabilities to either (a) the $AFE~     intervention (n=100); or (b) a usual care control (n=100). The investigators will~     interview veterans with psychiatric disabilities at baseline and six months. The~     investigators' central hypothesis, based on strong preliminary data, is that by fostering~     financial skills and judgment, the $AFE will concurrently increase employment, boost work~     motivation, and reduce disablement. If these outcomes are met, the investigators hypothesize~     the intervention will also lead to reduced psychiatric symptoms and homelessness among~     veterans with psychiatric disabilities.~   "
130093|NCT01352611|"~     The purpose of this study is to determine if intrathecal administration of baclofen can~     reduce symptoms of severe tactile defensiveness and autism spectrum disorder.~   "
130094|NCT01352598|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.~   "
130095|NCT01352585|"~     This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on~     the treatment response to anagrelide hydrochloride~   "
130096|NCT01352572|"~     The purpose of this study is to determine whether alteration of signal transduction~     components after antidepressant targeting, predict antidepressant responsiveness in advance~     before the appearance of the drug effects until 4~6 weeks after drug administration, or~     represent the clinical status of depressed patients.~   "
130097|NCT01352559|"~     The purpose of this study is to determine whether pharmacogenomic study of bioamine~     transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant~     responsiveness in advance before the appearance of the drug effects until 4~6 weeks after~     drug administration.~   "
130098|NCT01352546|"~     The use of Botox injections intravaginally and progressive dilation under anesthesia has~     been shown to cure vaginismus. This study expands the use of Botox injections to include~     progressive dilation, post procedure supervised dilation and sex counseling to help women~     transition from dilators to intercourse. Since 2005 patients continue to experience a cure~     rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been~     treated this way.~      In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus~     patients were able to advance to pain free intercourse (97%) and one patient failed to~     achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.~   "
130099|NCT01352533|"~     The goal of this study is to assess whether wound closure with skin adhesive or running~     stitches combined with skin adhesive will be superior to standard wound sutures. This is a~     split-wound study that will compare two methods of skin closure within one standard closure~     technique, thereby providing an internal control of running stitches within each wound. The~     investigators plan to measure outcomes by assessing for scar appearance, the incidence of~     wound opening, scar elasticity and subject satisfaction.~   "
130100|NCT01352520|"~     The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can~     help to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The~     safety of the study drug will also be studied.~   "
130101|NCT01352507|"~     The primary objective of this study is to evaluate whether, after two 8-week treatment~     periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg)~     tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each~     and an extension phase of 8 weeks, for a total of 24 weeks.~   "
130102|NCT01352494|"~     The purpose of this study is to assess the response of docetaxel and gemcitabine in the~     neoadjuvant setting in women with locally advanced breast cancer.~   "
130103|NCT01352481|"~     -  The aim of the present study is to examine the effectiveness of a short, highly~          structured parent based speech intervention program on speech development in very~          preterm children with a Speech Sound Disorder (SSD) at 2 years of age.~        -  The hypothesis of this study is that early intervention on speech development is~          effective in improving the speech development in preterm children with SSD at 2 years~          of age compared to a no treatment group (usual care at this age).~   "
130104|NCT01352468|"~     After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only~     two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a~     well-established evidence-base supporting their efficacy for children with ADHD. Both of~     these interventions have inherent limitations. Recently multiple studies have demonstrated~     that cognitive training may improve neuropsychological and behavioral functioning in~     children with ADHD. The magnitude of treatment effects for cognitive training has been~     comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate~     effect sizes). A limitation of existing cognitive training programs that may limit their~     efficacy is that each has employed a unifaceted approach. Each intervention program has~     targeted a single cognitive domain (e.g., working memory). This is problematic since as a~     group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory,~     attention, response inhibition, delay aversion, intra-individual variability) and thus a~     unifaceted intervention does not address the multifaceted array of cognitive dysfunction in~     children with ADHD. Also, because individuals with ADHD each have unique patterns of~     cognitive deficits, a unifaceted cognitive training approach may target areas which are~     non-deficient and miss areas of significant deficit in individual patients depending on~     their ideographic cognitive profile. The primary goal of the proposed research is to develop~     and test a multifaceted cognitive training intervention that addresses a comprehensive array~     of ADHD-related cognitive deficits thereby ensuring that children's unique areas of~     cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be~     developed consisting of four training tasks targeting response inhibition, verbal working~     memory, attention, and delay aversion. Each task will possess advancing levels of~     difficulty. On each task, children will receive feedback on performance accuracy as well as~     on intra-individual variability in reaction times. The software will be pilot tested in~     Phase I to determine performance thresholds and intervention duration. Also, focus groups~     will be conducted to obtain patient perceptions of each task's difficulty and interest~     level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in~     order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes~     will be collected on a wide range of neuropsychological, behavioral, and academic measures.~     Effect size estimates across outcomes will be used to guide sample size determinations for~     future clinical trials of multifaceted cognitive training.~   "
130105|NCT01352455|"~     A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the~     body. Many children with permanent kidney failure undergo dialysis, a life saving procedure~     that takes the place of a kidney. Currently, many children with permanent kidney failure~     only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on~     dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than~     their healthy counterparts. Survival for these children has not improved over the last 20~     years. These data indicate that the current dialysis treatment strategy is unacceptable.~      This research project will study if more frequent dialysis, performed 5 days per week, will~     improve the health of children with permanent kidney failure compared to the current~     treatment strategy. Children will be treated with both traditional and more frequent~     dialysis schedules to measure improvements in their health and well being.~   "
130106|NCT01352442|"~     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will~     provide an effective method of for the correction of presbyopia in patients who have normal~     distance vision but need correction such as glasses or contact lenses to see clearly at~     near.~   "
130107|NCT01352429|"~     This is a study to first establish feasibility of the study and then to register the~     treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer~     presenting for definitive radiation treatment with either proton radiotherapy or Intensity~     Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated~     strategy with our image guided treatment to further improve cancer control and decrease~     toxicity.~   "
130108|NCT01352416|"~     The objective of this study is to show that ranolazine is a safe, viable and potent~     alternative for post-operative atrial fibrillation suppression in patients undergoing~     cardiac surgery~   "
130109|NCT01352403|"~     The purpose of this study is to investigate the effects of gastric bypass in comparison to a~     intensive life style intervention on cardiac function and quality of life in patients with~     morbid obesity.~   "
130110|NCT01352390|"~     The goal of this project is to determine whether prompting the recipient of a health~     reminder mailing to ask his or her 4-9 year-old child to color on the reminder could~     increase engagement with the targeted health behavior~   "
130111|NCT01352377|"~     Assessing the precise MIC for the Ceftriaxone using E-test. To determine what proportion of~     susceptibility reports will be reclassified based on the new CLSI guidelines.Antibiotic~     susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing~     Enterobacteriaceae organism generated by the Phoenix machine will be obtained on a daily~     basis.MIC for Ceftriaxone will be noted.If the MIC is <=2 for Ceftriaxone,those cultures~     would be used to run an additional test - E- test.E-test gives us more precise MIC values~     compared to Phoenix machine.We will analyze the data collected over 2 months. We will~     determine the proportion of susceptibility reports reclassified based on the new CLSI~     guidelines.~   "
130112|NCT01352364|"~     This study aimed to assess and reassess the balance and motor skills of deaf children,~     passed six weeks of intervention and to verify whether a program of physical therapy~     intervention can match or improve motor skills. This study was quasi-experimental before and~     after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated~     using pre and post test KTK Coordination Body, and the activities were held once a week for~     six weeks in sessions of forty minutes. It was used for statistical analysis the Student t~     test dependent and independent (p ≤ 0.05).~   "
130113|NCT01352351|"~     The University of North Carolina (UNC) and Partners for Development (PFD), an American~     non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in~     Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for~     increasing the proportion of participants who exclusively breastfeed their infants until 6~     months. The investigators will build upon PFD's existing microcredit and reproductive health~     program by adding face-to-face breastfeeding education during borrowers' meetings and~     bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will~     remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention~     group will increase by 15%. The investigators will measure the effectiveness of the~     intervention by conducting baseline and final surveys with a cohort of 485 female borrowers~     who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be~     analyzed using logistic regression adjusting for possible confounders and the effect of~     clustering.~   "
130114|NCT01352338|"~     Study Phase: phase 1 and phase 2~      Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in~     patients with relapsed multiple myeloma previously treated with lenalidomide~      Study design: prospective, multicenter, non-randomized~   "
130115|NCT01352325|"~     The purpose of this study is to investigate the efficacy of system constellations in a~     monocentric, single-masked randomized controlled trial.~      The method of system constellations refers to an approach which integrates ideas from family~     systems therapy with elements from psychodrama. The constellations are conducted in a group~     based seminar-setting, each seminar lasting three days.~      Based on the model of a general psychotherapy and the consistency theory, the effects of~     system constellations on psychological functioning are explored.~      It is predicted that participation in a system constellation seminar changes the level of~     psychological functioning at 4 months.~   "
130116|NCT01352312|"~     This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab~     (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell~     Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal~     dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how~     safe these three drugs work together.~   "
130160|NCT01351714|"~     When performing a resection of the right colon due to cancer one aims not only to remove the~     tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph~     nodes are located along the arteries supplying the right colon. Through using a preoperative~     CT scan which can map these arteries very precisely one can ligate these vessels closer to~     their origin and thus remove more lymph nodes which may potentially harbor cancer cells.~     This study aims to compare patients operated more radically through use of preoperative CT~     which maps the mentioned arteries with patients operated in the standard way.~   "
130117|NCT01352299|"~     Orotracheal intubation the commonest method used to secure and maintain airway during~     anaesthesia. A variety of methods are available for orotracheal intubation such as digital~     or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA~     (which is becoming increasing popular, particularly in cased of anticipated difficult~     intubation), fibreoptic endoscopic orotracheal intubation (also used when a difficulty is~     predicted), and conventional and most common method, direct laryngoscopy. Orotracheal~     intubation is most commonly achieved after visualization of laryngeal inlet with direct~     laryngoscopy following induction of general anaesthesia and muscle relaxation achieved by~     administration of a muscle relaxant.~      Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for~     techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View~     obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane~     grading, the percentage of glottic opening (POGO Score)Literature suggests that straight~     blade gives better glottic visualization while tracheal intubation is easier with the curved~     blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms~     of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted~     intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview~     Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of~     intubation.~   "
130118|NCT01352286|"~     The purpose of this study is to 1) evaluate the safety and tolerability of autologous~     genetically modified T cells transduced to express the high affinity NY-ESO-1c259 TCR in~     HLA-A2+ subjects and 2) measure the incidence of GVHD in patients following infusion of TCR~     modified autologous T cells.~   "
130119|NCT01352273|"~     This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two~     stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and~     tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion~     part to further assess the safety and preliminary anti-tumor efficacy of this oral~     combination within two separate patient populations: i) patients with advanced solid tumors~     harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS~     mutations.~   "
130120|NCT01352260|"~     The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients~     undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System,~     Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to~     determine which modality best correlates with jugular venous oxygen saturation~   "
130121|NCT01352247|"~     In the majority of patients with osteoarthritis of the knee the disease originates in the~     medial compartment. There are two different approaches to replacing this arthritic area.~     Some surgeons feel that it is always best to replace both the knee compartments with a Total~     Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the~     knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee~     surgeons. Both interventions are established and well documented procedures, yet little~     evidence exists to support either practice. Each intervention is considered standard care.~     There exists little evidence, however, to prove the clinical and cost effectiveness of~     either management option.~      The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the~     clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee~     Replacements in patients with medial osteoarthritis. This will be examined using an~     appropriate patient base and long term assessments.~      The trial has a combined device/expertise based allocation depending on the local situation.~     Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR,~     randomisation and allocation can be based on device (UKR or TKR). The same surgeon will~     perform the operation for both arms of the study.~      For surgeons who hold a preference for one treatment over the other, an expertise based~     randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients~     recruited to the study from these sites will be randomised to one of the treatment options~     and treated by the appropriate surgeon. In such cases the patient is internally referred to~     the other surgeon's operating list.~      Patients will be recruited by their consultant knee surgeons in collaboration with the local~     research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the~     trial.~   "
130122|NCT01352234|"~     Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth~     retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic~     use of aspirin on the recurrence of placental insufficiency and its complications, mainly~     preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity~     in medical practice in Canada and around the world in terms of the dose of aspirin used.~      The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is~     associated with greater improvement in placental function assessed by biochemistry (sFlt-1~     and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a~     history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by~     a test used in several Canadian centers (PFA-100).~   "
130123|NCT01352221|"~     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,~     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with~     non-active Crohn's Disease (CD).~   "
130124|NCT01352208|"~     The study has three parts. Part 1 is a dose escalation to investigate the safety and~     tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial~     anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.~   "
130125|NCT01352195|"~     The primary purpose of this study is smoking cessation. The investigators are conducting a~     research study to learn how well the information from the program helps participants to quit~     smoking and remain smoke-free.~   "
130126|NCT01352182|"~     The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to~     determine the effect on inflammatory biomarkers for pioglitazone in patients with severe~     sepsis and septic shock.~   "
130127|NCT01352143|"~     The primary goal of this investigation is to determine the ability of recombinant activated~     factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation~     in neonatal plasma after CPB.~   "
130128|NCT01352130|"~     Postoperative nausea and vomiting [PONV] are common and distressing symptoms after surgery~     performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as~     well as treatment of PONV. After IRB approval we compared the effects of ondansetron and~     granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for~     carcinoma breast after written informed consent. The demographic data was collected. The~     administration of the anaesthetic was left to the discretion of the operating room staff~     specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of~     ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins~     (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate,~     Non-invasive blood pressure and SpO2 were also recorded. T~   "
130129|NCT01352117|"~     AIDS-related Kaposi's sarcoma (AIDS-KS) occurs in persons with HIV infection who are also~     infected with the Kaposi's sarcoma herpesvirus (KSHV). Several chemotherapy (anti-cancer)~     drugs work well in treating KS, but there is no treatment that cures KSHV infection. One~     chemotherapy drug called etoposide (VePesid®, ET) has caused KS tumors to get smaller in~     some people.~      Antiretroviral therapy (anti-HIV drugs or ART) is a group of medicines taken together to~     treat HIV infection. These medicines help to stop HIV from growing in the body. When this~     happens, your immune system, which fights infection and some cancers like KS, will get~     stronger. For some people, limited stage KS often improves or stays the same when they take~     ART. However, in some people KS gets worse when taking ART. These people may need~     chemotherapy at a later date.~      This study is being done to find out if taking ART with immediate etoposide (ET) is better~     than taking ART alone or ART with delayed ET to treat limited stage KS. The study will also~     try to better understand KSHV and to see what kind of side effects are caused by ART and ET~     and how safe ART and ET are.~   "
130130|NCT01352104|"~     Investigating effectiveness of the cognitive-behavioral based teacher training under routine~     care conditions by comparison of a baseline-interval with no special intervention to a~     following interval of PEP for the kindergarten teachers only each focussing on one child~     (3-6 years old) that the teacher herself indicated as needing special attention for~     externalising behaviour. Effects on child symptoms and teachers behavior and burden within~     intervention-period are expected to be stronger than those during waiting-period.~   "
130131|NCT01352091|"~     The present study is a randomized open-label -phase III study that aims to compare the~     efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and~     Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years~     for premenopausal breast cancer women with hormone receptor positive, lymph node positive or~     tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as~     endocrine responsive and endocrine response uncertain categories (table 3-1), and only those~     with ER or PR expression undetectable were considered as HR negative. The pathological~     evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary~     nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or~     directly through ALND when axillary nodes appeared to be positive in clinical examination.~     Based on the operating standard of local medical institution, identifying the numbers of~     lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station~     nodes accurately.~   "
130132|NCT01352078|"~     The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health~     records to study the reasons why some patients heal quickly and some have problems healing~     wounds. All patients seen in the Center for Wound Healing with an open wound are asked to~     participate. Information from this research may help to understand how to prevent and treat~     certain diseases.~   "
130133|NCT01352065|"~     Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of~     vasoactive drugs that have been developed for the treatment of pulmonary arterial~     hypertension. It has been anecdotally reported that ERA is frequently used among top-level~     athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase~     exercise performance. Yet, the effects of ERA on exercise capacity in healthy humans are~     puzzling, with the drugs not included in the current Prohibited List, since the ergogenic~     potential is yet to be fully understood and determined. Furthermore, the urinary excretion~     of ERA metabolites following administration has not been studied systematically at rest and~     during exercise in athletes, as a way to detect its intake if performance-enhancing~     potential is confirmed. In the planned study ERA will be administered in newly approved~     doses for 8 weeks in order to assess the presumed doping potential for both male and female~     athletes, and to monitor serum and urinary ERA excretion dynamics after single- and~     multiple-dose administration. The possible effects of prolonged ERA administration in higher~     doses on exercise performance may be relevant, if further confirmed, in terms of their~     possible fraudulent utilization to influence exercise performance in sports, raising the~     difficult question of whether, particularly in some circumstances, the ERA might be~     considered as prohibited substances in athletes.~   "
130134|NCT01352052|"~     The primary objective of the current study is to evaluate the outcome of an~     interdisciplinary multi-component rehabilitation programme customized to patients with~     chronic widespread pain (CWP) based on multidimensional diagnostic assessment including~     sub-grouping, and aiming to improve functional ability in everyday life. The hypothesis is~     that a patient-focused multi-disciplinary rehabilitation approach will improve both~     functional ability and quality of life for patients with CWP.~   "
130135|NCT01352039|"~     The primary objective and endpoints of the study is compare the efficacy of two products~     containing heparin sodium, evaluating if the formulation produced by Eurofarma can be~     considered non-inferior to the reference product.~   "
130136|NCT01352026|"~     Treatment of PAH includes exercise limitation, non specific agents (anticoagulants,~     diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative~     agents.~      Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic~     drug metformin, used in France since 1959 in diabetic type II patients, significantly acts~     at the pulmonary arteries level.~      According to these results, and knowing that metformin is a widely used drug, with a~     favorable safety profile, the investigators decided to set up a pilot study, in order to~     evaluate the activity of metformin in PAH treatment. In parallel, the investigators will~     focus on metformin mechanism of action.~   "
130137|NCT01352013|"~     The purpose of this study is to find out if omega-3 fatty acid supplements are more~     effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in~     patients with fibromyalgia.~   "
130138|NCT01352000|"~     The study primary purpose is smoking relapse prevention. This study is a collaboration~     between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt~     Cancer Center in Tampa, Florida, and those associated with the New York State Smokers'~     Quitline (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.~   "
130139|NCT01351987|"~     To analyze the change in International Prostate Symptom Score (IPSS) and serum~     prostate-specific antigen (PSA) level from baseline.~   "
130176|NCT01351506|"~     Aims of study~        1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in~          28 days~        2. Determination cut point of maximum weight change to outcome treatment~   "
130142|NCT01351948|"~     This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine~     candidates administered alone and with adjuvants in various schedules. These vaccines~     consist of inactivated viruses which have been modified, so they cannot reproduce in humans,~     and also to include genetic material for malaria protein AMA1 which is expressed by the~     malaria parasite during blood stage infection. The vaccines are designed to stimulate an~     immune response to this malaria protein and thus provide protection against malaria~     infection. Adjuvants are a crucial component of modern vaccine regimens, increasing the~     immunogenicity and potency of protein vaccines. In this study we will assess whether virus~     vectored vaccines combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909~     adjuvant (emulsion containing TLR agonist) can induce stronger and more durable immune~     response.~   "
130143|NCT01351935|"~     The purpose of this study is to evaluate the safety and tolerability of AVL-292 as~     monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL),~     chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).~   "
130144|NCT01351922|"~     This study is conducted in Asia. The aim of this observational study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     India. Perceptions and practices of physicians and subjects about diabetes management will~     also be evaluated.~   "
130145|NCT01351909|"~     This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib~     when given together in treating patients with breast cancer that has spread from where it~     started to nearby tissue or lymph nodes or to other places in the body. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving cyclophosphamide together with veliparib may work better in~     treating breast cancer.~   "
130146|NCT01351896|"~     This randomized phase II trial studies how well giving lenalidomide together with vaccine~     therapy works in treating patients with early-stage asymptomatic chronic lymphocytic~     leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by~     blocking blood flow to the cancer. It may also stimulate the immune system in different ways~     and stop cancer cells from growing. Vaccines may help the body build an effective immune~     response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a~     stronger immune response and kill more cancer cells.~   "
130147|NCT01351883|"~     Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines~     and reduce postoperative infectious complications and length of hospital stay after major~     upper gastrointestinal surgery.~      (ANOM®)immunonutrition product name~   "
130148|NCT01351870|"~     This is an international prospective randomised trial, which will compare two radiotherapy~     regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with~     carefully staged 'standard risk' medulloblastoma.~   "
130149|NCT01351857|"~     Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D)~     improves diabetes clinic attendance as well as glycemic control after transition from~     pediatric to adult diabetes care.~   "
130150|NCT01351844|"~     Patients have been asked to participate in the CEASE study because their treating oncologist~     has recommended that they start an aromatase inhibitor medication. These medications are~     associated with joint complaints. The purpose of this study is to see whether a~     computer-based educational module is a feasible intervention to help address these symptoms.~     If the patients agree to participate, a research coordinator will test their grip strength~     and give them a computer log-on code. They will be shown how to log-on to complete the~     educational module and a few simple questionnaires. Patients have the option to do this from~     home if they wish. In 3 months time, the investigators will ask patients to return to the~     clinic and have another grip strength evaluation and complete some additional~     questionnaires. The computer module and the follow up visit will each take about 30 minutes~     of time.~   "
130151|NCT01351831|"~     Background and purpose:~      In the early phase after a total knee replacement (TKA), patients experience a decrease in~     leg muscle strength with up to about 80%. This considerable loss of muscle strength is~     related to reduced functional performance at this point in time. As the loss of muscle~     strength and functional performance is most pronounced early after TKA, rehabilitation~     including strength training initiated early after TKA seems a logical choice. However,~     tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain~     and slow recovery of knee joint range of motion, have typically precluded strength training~     early after TKA.~      Hypothesis:~      Our hypothesis is that the effect of early rehabilitation including strength training will~     be greater than rehabilitation without strength training. If the hypothesis is confirmed,~     strength training early after TKA could be implemented directly into clinical rehabilitation~     practice.~      Participants and methods:~      Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who~     understand and speak Danish, have given informed consent, will be included in this study.The~     study is a single-blinded randomized controlled study, where the participants receive~     supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks.~     All components of the rehabilitation program (balance-, and mobility training etc.) are the~     same in both groups except the strength training exercises. Instead of the strength training~     exercises, the group without strength training spend more time on warm-up exercises,~     mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and~     will be performed twice per week. The participants perform a test battery 4 times from~     before to 6 months after the TKA. The test battery assesses the participants' walking~     ability, leg strength, knee pain, knee joint swelling- and range of motion, and~     self-reported function and quality of life.~      Ethical issues:~      From a pilot study conducted in the beginning of 2010, the investigators found, that~     strength training initiated early after TKA seems feasible, and does not increase knee joint~     swelling and knee pain. None of the financial supporters, or any of the authors, have any~     potential conflicts of interest with regard to the study.~   "
130152|NCT01351818|"~     To assess the influence of exogenous GH (growth hormone) administration on adipocyte~     endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children~     with delayed growth due to GH deficiency.~      Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and~     ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a~     regulatory effect on such hormones.~   "
130177|NCT01351493|"~     The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore~     recovery.~   "
130178|NCT01351480|"~     The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept~     provides any structural benefit in patients with rheumatoid arthritis who have failed prior~     use of TNF therapy.~   "
130179|NCT01351467|"~     The purpose of this study is to examine how genes and environment affect risk for~     Parkinson's disease.~   "
130679|NCT01344941|"~     The primary objectives of this study is to~        -  Define the envelope-specific B-cell and T-cell responses in humans who have received a~          St. Jude HIV-1 vaccine.~        -  Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell~          activities.~   "
130153|NCT01351805|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,876 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among VITAL participants and will~     examine whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B)~     biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and~     in follow-up will be collected in a randomly selected subcohort of 2000 individuals and~     analyzed for changes in biomarkers of systemic inflammation: C-reactive protein,~     interleukin-6, and tumor necrosis factor-receptor 2. Approximately 2000 individuals with~     chronic, frequent knee pain will be followed with annual questionnaires to evaluate the~     effects of the supplements on chronic knee pain.~   "
130154|NCT01351792|"~     The purpose of the present study is to demonstrate the higher efficacy of small particles~     Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations~     b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic~     Obstructive Pulmonary Disease (COPD) patients.~   "
130155|NCT01351779|"~     Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows~     progressive damage with characteristic loss of visual field. Glaucoma is very commonly~     associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown~     to increase when lying down in normal subjects as well as patients with glaucoma. It is~     possible that this effect can make glaucoma worse. This study is designed to investigate the~     effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each~     patient will be required to attend for 2 separate 24 hour visits. On one visit the patient~     will be required to sleep flat and on the other visit at a 30° head up sleeping position.~     During this time the patient will be required to wear a soft contact lens (SENSIMED~     Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP~     measurements are wirelessly transmitted to a recorder.~   "
130156|NCT01351766|"~     Evidence suggests a significant percentage of adolescent regular smokers are interested in~     trying to quit smoking and frequently make attempts to quit, yet are unsuccessful in~     maintaining abstinence on their own. Despite a genuine desire to quit on the part of many~     adolescents, there is an increasing incidence of smoking among older adolescents that runs~     counter to the overall trends of smoking reduction seen in the general population.~     Unfortunately, psychosocial and pharmacological smoking interventions have yet to indicate~     clear effectiveness with youth. Moreover, depression-related vulnerabilities, particularly~     currently elevated depressive symptoms, are highly comorbid with smoking behavior and~     dramatically reduce cessation rates. As a result, new approaches to smoking cessation are~     needed for adolescent smokers with currently elevated depressive symptoms. Thus the~     objective of the present study is to develop a specialized behavioral activation treatment~     for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we~     utilize focus groups and pilot testing with 15 youths to develop the behavioral activation~     smoking treatment for youth (BATSY). In Phase II, we will conduct an open-label trial of~     BATSY plus nicotine replacement therapy with 30 youths who will also take part in a~     neuroimaging protocol examining reward sensitivity. Participants will be followed over 26~     weeks post-quit date.~   "
130157|NCT01351753|"~     Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality,~     but is difficult to treat. Partly this is due to the transient, arduous and modest nature of~     lifestyle interventions. Partly it is due to the limited efficacy and safety problems of~     existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity;~     but its effects on weight are relatively small. There are drugs that have been approved for~     other diseases but which also reduce weight. One promising approach to treating obesity is~     combination therapy with orlistat and one or more of these other agents. The investigators~     propose an innovative approach to developing new therapies for obesity coupling the use of~     combination therapy with rigorous assessment of cardiovascular safety. Vascular function is~     a quantitative surrogate clinical endpoint that has been strongly and independently linked~     to future cardiovascular events.~      Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular~     function in obese human subjects. The co-primary endpoints will be weight and vascular~     function.~   "
130158|NCT01351740|"~     A drug-drug interaction between the anti-HIV drugs tenofovir DF (TDF) and atazanavir (ATZ)~     results in lower ATZ plasma levels when the drugs are given together, particularly in~     patients not taking ritonavir to boost ATZ levels. Lower plasma drug levels may make the~     anti-HIV regimen less effective in controlling the HIV virus levels in the blood. For this~     reason, current treatment guidelines recommend that ATZ always be boosted with ritonavir in~     regimens also containing TDF. However, withdrawal of ritonavir is often desirable given the~     tolerability and toxicity issues with this agent, even at the low dose (100 mg daily) used~     to boost ATZ. For example, ritonavir can cause stomach upset, nausea, diarrhea, high~     cholesterol levels, and liver enzyme abnormalities.~      However, there is evidence that plasma ATZ levels may not predict treatment success on~     unboosted ATZ regimens, particularly among people whose plasma HIV virus is already under~     control and unboosted ATZ is being used as a maintenance strategy. In the BC Centre for~     Excellence in HIV/AIDS Drug Treatment Program (DTP), nearly 100 patients originally treated~     with ritonavir-boosted ATZ + TDF (+ FTC or 3TC) are receiving successful maintenance therapy~     with unboosted ATZ and the same TDF-based backbone.~      The study will examine the hypothesis that switching to maintenance therapy with unboosted~     ATZ 400mg daily will have similar 48-week virologic efficacy to continuing ATZ/ritonavir~     300/100mg daily among HIV-infected adults with stable viral load suppression on regimens~     comprising ATZ/ritonavir 300/100mg daily with TDF plus either FTC or 3TC, despite~     potentially lower ATZ trough levels with the unboosted regimen. In other words, patients~     whose HIV viral load is undetectable while receiving TDF (+FTC or 3TC) and ATZ/ritonavir~     will continue to maintain an undetectable viral load after switching to unboosted ATZ~     without ritonavir, in the same proportions as those continuing on their boosted~     ATZ/ritonavir regimen.~   "
130159|NCT01351727|"~     The purpose of this proposed research is to identify individuals in southeastern Arizona~     aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and~     monitor them for at least two years. In doing so the investigators will be able to describe~     the public health burden of this condition and to identify factors that predict clinical~     outcomes and health care needs in this population, using quantitative, administrative, and~     qualitative data. The aims of this proposed research are 1) to determine the two-year~     incidence of newly diagnosed epilepsy in the target population, 2) describe health care~     resource utilization of the target population using Medicare data, 3) validate the use of~     Medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of~     this condition in different ethnic groups.~   "
130696|NCT01344707|"~     The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting~     Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and~     pharmacokinetics.~   "
130161|NCT01351701|"~     The pattern of organism causing diabetic foot infection are presumed to vary from location~     to location depending on the antibiotic prescription practice, geographical locations,~     environmental variations and therapeutic interventions for various patients. Our hypothesis~     is look to finding out common similarities with diversified subgroups spread across various~     geographical locations of eastern part of India, thus to create a data base for treating~     patient with diabetic foot infections.The sensitivity pattern is anticipated to be different~     from institution to institutions and place to place but the gross sensitivity data of local~     pathogen could guide physician for choosing right empirical antibiotic. Practice guideline~     could be postulated from the collated data of distribution of pathogens, their sensitivity~     pattern as well as co-morbid conditions of the sufferers.~   "
130162|NCT01351688|"~     The primary aim of study is to gain an initial assessment of safety and tolerability of~     AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a~     preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to~     Japanese patients with metastatic castration resistant prostate cancer.~   "
130163|NCT01351675|"~     This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying~     progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with~     Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.~   "
130164|NCT01351662|"~     Linking a psychosocial stress intervention with clinical measures of stress in African~     American lupus patients will assess the utility of this method in reducing perceived stress,~     and provide the necessary preliminary steps toward future investigations of potential~     mechanisms.~   "
130165|NCT01351649|"~     Specific aims are:~        1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2)~          adherence to protocols; and (3) user and provider (nurse and PA Club instructors)~          satisfaction.~        2. Explore if participants in the intervention group, compared to those in the control~          group, show improvement in the primary outcome of minutes of moderate to vigorous~          physical activity (MVPA; measured by accelerometer), and also secondary outcomes of~          self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and~          waist circumference at 6 months.~        3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA,~          perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective~          (enjoyment of PA) variables.~        4. Explore if participants in the intervention group, compared to those in the control~          group, have greater minutes of MVPA at 7 months.~   "
130166|NCT01351636|"~     The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality~     and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.~   "
130167|NCT01351623|"~     The purpose of this study is to test a new drug called carfilzomib. It is a type of drug~     called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to~     the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins~     cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma~     cells make a lot of protein and are especially in need of a functional proteasome to~     survive.~      Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It~     is considered an experimental drug. Previous studies have shown that carfilzomib is safe to~     use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.~   "
130168|NCT01351610|"~     MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow~     derived stem cells for the treatment of Critical Limb Ischemia~   "
130169|NCT01351597|"~     The purpose of this study is to evaluate the overall response rate, toxicity, progression~     free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in~     recurrent or metastatic breast cancer.~   "
130170|NCT01351584|"~     The registry aims to collect and analyse information on the antineoplastic treatment of~     breast cancer in daily routine practice of office-based and clinic-based medical oncologists~     in Germany.~   "
130171|NCT01351571|"~     This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in~     combination with interferon alpha-2a as first-line treatment in patients with advanced~     and/or metastatic renal cell carcinoma. Data will be collected from each patient for up to 4~     years.~   "
130172|NCT01351558|"~     There is ample evidence that exercise therapy is beneficial with respect to pain in patients~     with osteoarthritis of the knee. However, the pain relieving mechanisms are unknown. To~     enhance the efficacy of exercise therapy a deeper understanding of the involved mechanisms~     is needed.~      Different exercise types may affect the pain sensitivity differently. It is hypothesized~     that non-specific exercises (i.e. exercises that does not involve the knee) reduces the~     processing of pain in the central nervous system (central sensitivity) to knee joint pain in~     healthy subjects. It is also hypothesized that exercises that involve the knee (i.e.~     specific knee exercises) reduce the sensitivity of pain receptors in the knee (peripheral~     sensitivity) in healthy subjects.~      Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle~     strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises~     involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no~     exercises). The active interventions include exercises three times per week for 12 weeks.~     Pain sensitivity and a range of explanatory variables is measured before the interventions,~     after 4 weeks and after 12 weeks.~   "
130173|NCT01351545|"~     This study is an access and distribution protocol for unlicensed cryopreserved cord blood~     units (CBUs) in pediatric and adult patients with hematologic malignancies and other~     indications.~   "
130174|NCT01351532|"~     The purpose of this research is to apply this smoking cessation program on oral cancer~     patients, and to analyze the effectiveness of it.~   "
130175|NCT01351519|"~     In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA)~     prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor~     tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light~     in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink~     allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The~     aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue~     improves the surgeon's ability to completely resect or remove the brain tumor.~   "
130180|NCT01351454|"~     The objective of the current study is to test a novel, behavioral approach to treat~     depressive symptoms and improve HIV medication adherence and subsequent physical health~     outcomes among African American HIV-infected substance users residing in inner-city~     Washington, DC. This treatment will serve as a compliment to standard residential and~     follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms~     and improving HIV medication adherence, physical health, and substance use outcomes.~   "
130181|NCT01351441|"~     It has been shown that patients can improve their safety through informed choice, safe~     medication use, and complication reporting. This includes not only the potential problems~     that occur from prescription medication use but also issues that may arise through the~     improper use of over-the-counter medications. The willingness of a patient to take on safety~     action is known to be complicated by an unwillingness to behave in a manner that might~     challenge a physician's judgment or actions. Community pharmacists are in the unique~     position to provide perspective on the physician's recommendation and act as an advocate to~     facilitate necessary change. Through supportive and repeated interaction with their~     community pharmacist patients will develop assertiveness toward their own health care, an~     increased frequency and quality of interaction with their physician, and thus a minimized~     risk of harm and maximized opportunity to optimize clinical outcomes.~   "
130182|NCT01351428|"~     Preeclampsia is associated with significant maternal and fetal morbidity and mortality.~     Early identification and subsequent management of patients at risk of developing~     preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be~     identified from:~        -  serum screening abnormalities in the first or second trimester~        -  placental shape and texture at the 18-20 anatomical ultrasound~        -  uterine artery blood flow.~      Early identification and effective treatment of patients would permit the safe completion of~     the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular~     monitoring have enabled the study of maternal hemodynamics in normal and at-risk~     pregnancies. This study hopes to identify the earliest significant changes in maternal~     hemodynamics which may allow targeted therapeutic interventions in patients at high risk of~     developing preeclampsia.~      The hypothesis of this study is that systemic vascular resistance rises during the~     pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance~     technology. Treatment of the abnormally high vascular tone may decrease the severity and~     postpone the onset of clinical disease.~   "
130183|NCT01351415|"~     This open-label, randomized, multicenter study will evaluate the efficacy and safety of~     bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants~     with advanced non-squamous NSCLC. Participants will be enrolled at documentation of~     progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a~     platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance~     treatment prior to PD. Participants will be randomly assigned to one of two treatment arms~     to receive either bevacizumab plus SOC treatment or SOC treatment alone.~   "
130184|NCT01351402|"~     This study will investigate the effects of 15 minutes of massage compared to 15 minutes of~     quiet rest on physiological variables. Specifically, the investigators will measure the~     effects on levels of the social hormone oxytocin, and on other physiological variables that~     interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin,~     and IL-1alpha). The investigators will also investigate whether, in the case of hormones~     changes, these influence social decision making.~   "
130185|NCT01351389|"~     This brief alcohol and sexual risk taking intervention has the potential to influence the~     public health by reducing alcohol use and sexual risk taking behavior in individuals who are~     seeking treatment in an Emergency Department.~   "
130186|NCT01351376|"~     This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast~     cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy~     (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition~     of LLLT to CDT will result in statistically significant improvements and greater long-term~     benefits as measured by changes in arm volume and girth, pain levels, tissue texture,~     symptoms experienced, and quality of life when compared to the benefits of CDT alone for the~     treatment of breast cancer-related lymphedema.~   "
130187|NCT01351363|"~     Following arthroscopic shoulder surgery a small but significant number of people suffer~     severe postoperative pain.~      This study aims to predict which patients are at risk of developing severe post operative~     pain so that they may be targeted with a more aggressive post operative pain regimen.~   "
130188|NCT01351350|"~     This is a Phase I, Open Label, Dose Escalation Study of Oral Administration of MLN0128 in~     Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid~     Malignancies~   "
130189|NCT01351337|"~     Resection of brain tumors in eloquent areas involves the risk of postoperative motor~     deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor~     resection while preserving motor function is crucially important.we used DTI-based~     tractography to visualize the spatial relationship between brain lesions and the nearby~     pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional~     connections of the illustrated PT by direct electrical stimulation. We evaluated the~     reliability of DTI-based tractography for PT mapping using intraoperative subcortical~     stimulation ) and the usefulness of the combination of two techniques.~   "
130190|NCT01351324|"~     Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and~     insulin sensitivity but the impact of NEFA composition is unknown.~      The objective was to test the effect of acute elevation of NEFA enriched with either~     saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3~     PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser~     Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a~     hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.~   "
130191|NCT01351311|"~     The aim of the present study is to assess the effectiveness of resistance training with~     swiss ball in the treatment of patients with ankylosing spondylitis.~   "
130377|NCT01349101|"~     It is hypothesized that engraftment when administering cyclophosphamide post the stem cell~     infusion will increase, the incidence of graft versus host disease (GVHD) and day 100~     mortality will decrease, and the use of cyclophosphamide post stem cell infusion with~     alternative donors will be as safe and as effective as traditional matched transplants.~   "
130192|NCT01351298|"~     Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This~     diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in~     outpatients. The purpose of this randomized controlled double-blind study is to determine~     whether there is a difference in the degree of discomfort experienced by children undergoing~     flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo~     (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C)~     decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine~     hydrochloride).~      Null hypothesis: There is no difference in the degree of reported discomfort experienced~     (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after~     receiving either intra-nasal topical placebo, decongestant, or decongestant with local~     anesthetic.~   "
130193|NCT01351285|"~     It has been reported that target-controlled infusion of remifentanil can reduce cough~     against endotracheal tube during emergence from general anesthesia. We hypothesized that~     effective concentration of remifentanil for preventing cough during anesthetic emergence~     varies depending on the type of main anesthetic agents which is administered with~     remifentanil during general anesthesia. The purpose of this study is to evaluate the~     effective concentrations of remifentanil to prevent coughing during emergence from general~     anesthesia according to main anesthetic agent (sevoflurane, desflurane, and propofol).~   "
130194|NCT01351272|"~     In this study the investigators will measure the functional brain activity of adult~     Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT~     genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment~     with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the~     therapeutic effect of MPH treatment on cognitive functions.~   "
130195|NCT01351259|"~     Underinflation and overinflation of tracheal cuff are common in intubated patients,~     including those intubated with polyurethane-cuffed tubes. The aim of this study is to~     determine the efficiency of a pneumatic device in controlling cuff pressure.~   "
130196|NCT01351246|"~     Cognitive-behavioral based guided self-help for parents of children with~     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and~     effectiveness study. The treatment is offered under routine-care conditions of the~     health-care system in Germany. Practicability, treatment participation and effectiveness is~     documented and tested in a one-group pre-test/post-test design.~   "
130197|NCT01351233|"~     The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric~     intraocular lens in the bag in high myopic subjects.~   "
130198|NCT01351220|"~     Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of~     diagnosis and poorer survival relative to other racial/ethnic groups. To address this~     disparity, the investigators developed a multi-component intervention to increase CRC~     screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010).~     This study aims to determine how an intervention to increase CRC screening can best be~     integrated within the cultural norms and existing structures of churches and community based~     organizations (CBOs) with predominantly Filipino American membership to ensure broad~     dissemination to those in need of screening.~      The investigators will provide our partner CBOs with resources and technical assistance,~     including training of community volunteers as health advisors, to enable them to promote CRC~     screening to their constituents. Using a scientifically rigorous research design, the~     investigators will compare two dissemination strategies: Basic dissemination which consists~     of a single kick-off event during which community health advisors will receive print~     materials and FOBT kits for distribution and training on how to conduct educational~     small-group sessions; and Organizational dissemination aimed at integrating CRC screening~     dissemination into organizational practices and processes that can be sustained after the~     end of the study. The study will be implemented in 20 CBOs and will train 100 community~     health advisors (CHAs). The impact of the two dissemination strategies will be~     comprehensively assessed by collecting data at the CBO level, from the CHAs and from 1000~     Filipino American participants. The investigators will compare the proportion of Filipino~     American participants who obtain CRC screening by dissemination strategy, but the~     investigators will also assess how many are reached, if the intervention is implemented as~     planned, how CBOs support the screening efforts at their regular activities, and if CBOs and~     CHAs maintain their efforts over the 4 years of the study.~      The investigators hypothesize that CBOs can implement evidence-based strategies to promote~     CRC screening and CHAs in the organizational dissemination arm will reach more participants~     and more screened participants than CHAs in the basic dissemination arm; and organizations~     in the organizational dissemination arm will adopt more CRC screening activities and~     maintain these better than organizations in the basic dissemination arm.~   "
130199|NCT01351207|"~     The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot~     study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism~     when included with other cooked breakfast foods typically selected by older Americans.~   "
130200|NCT01351194|"~     Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms~     of overall survival and disease-free survival. This has prompted some authors to suggest~     that PRFA could be more suitable than HR for early stage HCC. Some authors also have~     suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤~     2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location,~     adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the~     risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our~     previous experience, some tumors (with deep locations, which were included as central HCC)~     may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood~     loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC~     tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the~     investigators conducted a study that included a consecutive series of patients with single~     resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.~   "
130226|NCT01350856|"~     Because the artemisinins are the most potent antimalarial drugs, the reduction in parasite~     numbers is rapid. Therefore, early measures of reducing parasite counts are needed. This~     study will look at conventional markers of parasite reduction e.g. parasite clearance time,~     parasite reduction ratio, and the time to achieve a fall of 50%, 90% and 99% of the~     pre-treatment parasitaemia.~      Defining artemisinin resistance requires the use of artesunate (AS) alone because it is now~     appreciated that the partner drug in a combination treatment has a significant impact on the~     rate of parasite clearance. This study will dose patients for 3 days with AS alone (or~     longer until parasites clear) and measure the parasite count frequently in order to be able~     to define an accurate regression line of a graph of the natural logarithm of the parasite~     count (Y axis) versus time (X axis). This will be followed by a full course of an~     artemisinin combination therapy (ACT). Two different dose regimens of artesunate will be~     compared at all sites except those in western Cambodia, as unpublished observations from the~     Thai-Myanmar border suggest the standard lower daily dose of 2mg/kg may enable the earlier~     detection of low level resistance than a 4mg/kg daily dose.~   "
130201|NCT01351181|"~     Type II diabetes is an important condition with a UK prevalence of 3.54% affecting~     approximately 2.5 million people across the country. Diabetics have a fivefold increased~     risk of cardiovascular disease and over 65% of diabetics will die from coronary heart~     disease or stroke. Exercise is one of the management tools along with medication and weight~     reduction available to improve diabetic control reducing morbidity and mortality. Exercise~     promotion might be more effective at a population level if it could be incorporated in a~     simple form as part of pre-existing routine care. This case control study seeks to assess~     the effectiveness of written exercise advice given to Type II diabetics at the time of their~     annual review. The study will be open to all Type II diabetics in a single general practice~     attending their routine nurse led annual review. The intervention uses leaflets prepared as~     part of a previous study the Time2Act study and assessment will be by self-reported~     questionnaires. Follow up will be over 12 months but the study design will allow for longer~     durations. Previous studies have demonstrated the effectiveness of exercise as an~     intervention but have often been hospital-based and used exercise interviews as the main~     intervention rather than incorporating exercise advice into structures already established~     in routine Primary Care. If this study demonstrates that a simple intervention carried out~     as part of routine care has a positive effect if only at a low level then disseminating this~     knowledge across the country would bring significant benefits to Type II diabetics.~   "
130202|NCT01351168|"~     Levodopa treatment is associated with long-term complications. Dopamine deficiency is~     associated with abnormal activity in certain parts of the brain. Zolpidem may change this~     abnormal activity and, by doing so, may work in a different way than levodopa to help~     parkinsonism.~      The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving~     motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind,~     cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2~     doses of ZLP in a randomized order on 4 different occasions, about one week apart.~   "
130203|NCT01351155|"~     In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV),~     the main complication of the use of the mask is the development of decubitus, sometimes so~     severe and painful as to force a suspension of the NIV itself . The lesions are mainly~     located at the nasal bridge, as at this level the skin thin and placed directly on the bone~     is particularly vulnerable to the injury as consequence of the friction and pressure induced~     by the movement of the mask. The strategy of prevention and treatment commonly adopted is~     the application of hydrocolloids.~      However, precise data are lacking about the demonstration of the effectiveness of these~     devices and the possibility of using other protective devices.~      The purpose of this study was to evaluate the usefulness of large-scale three different~     systems of protection vs. no protection in preventing the development of decubitus lesions~     in patients receiving NIV for an episode of ARF.~   "
130204|NCT01351142|"~     Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks~     of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in~     the brain of patients with AD.~      The main objective of our study is to analyse the correlation between the value of plasma~     cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive~     decline in AD over a 2-year follow-up.~      Secondary objectives include:~        -  the predictive value of the cytokines on the cognitive decline after 6 months and one~          year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)~        -  correlation between plasma cytokines levels and expression of the protein kinase PKR~          (involved in death cell) in blood mononuclear cells.~   "
130205|NCT01351129|"~     The primary purpose of this study is to evaluate the pharmacokinetics, safety and~     tolerability three different formulations of PF-04991532 in healthy adult subjects.~   "
130206|NCT01351116|"~     A trial to improve the quality of life of patients with advanced non-small cell lung cancer~     (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving~     external radiation with or without high dose internal radiation.~   "
130207|NCT01351103|"~     This primary purpose of this study is to find the recommended dose of LGK974 that can be~     safely given to adult patients with maliganacies dependent on Wnt ligands for whom no~     effective standard treatment is available.~   "
130208|NCT01351090|"~     This was a randomized, double blind, placebo-controlled study in subjects who have undergone~     major surgery. Each subject's study participation consisted of a screening visit, a 2-day~     treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned~     to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain~     intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter,~     subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain~     not relieved by the study drug, the subjects had access to morphine sulfate (MS)~     administered via patient controlled analgesia (PCA).~      The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN)~     doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and~     tolerability of this dosing regimen.~   "
130209|NCT01351077|"~     Between 12 and 16% of children in the United States have a developmental disability.~     Research has demonstrated that early intervention programs are not only essential for~     improved outcomes in these children, but also cost-effective. As a result, there has been a~     push within the pediatric medical community to identify children with developmental delays~     or disabilities as early as possible. Currently, most pediatric primary care providers do~     not use standardized methods for developmental surveillance and screening. Instead they rely~     on intuition and clinical judgment which has been shown to have limitations when compared~     with standardized screening methods. Researchers and physician organizations such as the AAP~     have called on pediatric primary care providers to institute a standardized approach for the~     identification of developmental delays that includes both developmental surveillance and~     screening. In fact, the AAP recently published an algorithm for developmental surveillance~     and screening within a primary care setting. Physicians, however, cite several barriers to~     the implementation of these recommendations within their practices, including lack of time,~     lack of office staff, inadequate reimbursement, and language barriers.~      The investigators have developed a novel computer decision support system (CDSS) for~     implementing clinical guidelines and algorithms within pediatric practices called CHICA. The~     investigators believe that this CDSS has the potential to address the barriers cited in~     previous studies as obstacles specific to the implementation of developmental surveillance~     and screening within primary care practices. CDSS will allow for developmental surveillance~     and screening to fit within the workflow of a busy pediatric practice without requiring an~     additional investment of time on the part of the physician and without requiring additional~     office staff.~      The aims of this study are to (1) Expand and modify an existing computer-based decision~     support system (CHICA) to include the 2006 AAP developmental surveillance and screening~     algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and~     screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system~     on referrals for developmental and medical evaluations as well as early developmental~     intervention/early childhood services for those children identified as having concerning~     developmental screening results; and (4) Develop a cohort of children with identified~     developmental disabilities that can be followed over time in order to look at the end~     results/effects of developmental screening~   "
130210|NCT01351064|"~     Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral~     disorder in children. Prevalence rates in the United States range from 2% to 18% depending~     on diagnostic criteria and population studied. Primary care physicians, especially~     pediatricians, have historically played a large role in the diagnosis and treatment of ADHD.~     Despite the existence of authoritative guidelines to assist primary care physicians, ample~     evidence demonstrates that they continue to diagnose and treat this disorder suboptimally.~     This is due, in part, to a lack of training and cumbersome delivery system designs. Modern~     computer decision support strategies offer the best hope of equipping general practitioners~     to deal with the mental health epidemic of ADHD.~      The investigators have developed a novel decision support system for implementing clinical~     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer~     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a~     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing~     electronic medical record systems. The result is a system that both delivers just-in-time~     patient-relevant guidelines to physicians during the clinical encounter, and accurately~     captures structured data from all who interact with it. Preliminary work with CHICA has~     demonstrated the feasibility of using the system to implement and evaluate clinical~     guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and~     treatment guidelines. The investigators hypothesize that implementation of the ADHD~     guidelines will result in better outcomes, including higher rates of adherence to~     recommendations and improved patient functioning.~   "
130211|NCT01351051|"~     This study will aim to identify genetic, medical, dietary and environmental factors~     associated with the development of endometrioma and/or deep infiltrating endometriosis in~     order to move towards early diagnosis and implementation of potential preventative measures.~   "
130212|NCT01351038|"~     This is an open label, multicenter, single-arm phase II trial with primary~     eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with~     resectable, histologically proven gastric or esophageal cancer.~   "
130213|NCT01351025|"~     ACTG A5275 was a prospective, double-blind, randomized, placebo-controlled cross-over design~     pilot study evaluating the effect of atorvastatin on biomarkers of inflammation,~     coagulopathy, angiogenesis, and T-lymphocyte activation in HIV-1 infected individuals with~     suppressed HIV-1 RNA on stable protease inhibitor based antiretroviral therapy with fasting~     LDL cholesterol < 130 mg/dL.~      Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for treating high~     cholesterol. Atorvastatin has also been able to lower the level of inflammation blood tests~     in certain other diseases but has not been studied for this purpose in people who have HIV.~     The main goal of this experimental study is to see how taking atorvastatin affects~     inflammation blood tests in people infected with HIV who do not need to take medicine for~     high cholesterol. In addition to observing the effects of atorvastatin on the level of~     inflammation measured in the blood, this study evaluated if atorvastatin is safe for people~     with HIV who are also taking medication for HIV.~   "
130214|NCT01351012|"~     The purpose of the study is to examine how the consumption of different dietary oil~     varieties affects a broad range of metabolic responses that are important in the development~     of cardiovascular diseases. This study will examine the relationship between dietary oil~     consumption and arterial function, blood fat content, and blood markers of cardiovascular~     disease risk. Additionally, the efficiency of the body in converting fat from dietary oils~     into other specific fat compounds with know health benefits will be examined. Also, the~     correlation between psychosocial parameters and vascular function will be studied.~   "
130215|NCT01350999|"~     The purpose of this study is to determine the safety and efficacy of TAK-085, once daily~     (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily~     (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.~   "
130216|NCT01350986|"~     The efficacy of cognitive-behavioral based guided self-help for parents of children with~     externalizing problem behavior is tested in a randomized clinical trial. Parents work~     through cognitive-behavioral self-help booklets and additionally receive counseling~     telephone calls every two weeks. In the control condition parents are provided non-directive~     self-help booklets and additionally receive counseling telephone calls. It is hypothesized~     that the cognitive-behavioral treatment is superior.~   "
130217|NCT01350973|"~     The purpose of this study was to determine the efficacy and safety of TAK-085, once daily~     (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily~     (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.~   "
130218|NCT01350960|"~     The purpose is to study Safety and Tolerability.~   "
130219|NCT01350947|"~     The primary objective of this study is:~      Response to treatment will be evaluated according to the revised International Working Group~     (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The~     primary objective is:~      To determine the rate of complete hematologic response and hematologic improvement~     (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.~   "
130220|NCT01350934|"~     This study will evaluate whether the once weekly administration of the combination tablet~     alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD)~     more than the daily use of calcitriol.~   "
130221|NCT01350921|"~     Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken~     together in healthy volunteers~   "
130222|NCT01350908|"~     Circulating tumor DNA detection and quantification in patients with ovarian cancer.~   "
130223|NCT01350895|"~     To study the clinical and biochemical characteristics women with polycystic ovary syndrome~     (PCOS) in different aged groups.~   "
130224|NCT01350882|"~     Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a~     composite TREATMENT FAILURE~   "
130225|NCT01350869|"~     The objective of this study is to evaluate effectiveness and safety of everolimus-eluting~     stents (XIENCE, Abbott) in the real world daily practice as compared with first-generation~     drug-eluting stents (sirolimus-eluting stents).~   "
130270|NCT01350284|"~     The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the~     gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood~     glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a~     healthy adult population.~   "
130227|NCT01350843|"~     The aim of this study is primarily to investigate the ability of antioxidants found in~     orange juice (OJ) to improve the serum lipid profile. Overweight or mildly obese men, who~     are otherwise healthy, but with elevated serum total cholesterol concentration will be~     recruited. The time commitment for subjects is ~14wks. Subjects will attend the laboratory~     on 5 occasions after fasting from midnight. The 1st is a medical screening. Laboratory~     visits 2 & 5 will take ~90min and will be separated by 3 months, during which time subjects~     will consume 250ml of an orange drink (either OJ or an orange flavoured control drink) once~     a day. During visits 2 & 5, subjects will have a scan to assess their %body fat using a~     low-dose x-ray machine, a 20ml blood sample taken and a small sample of fat tissue (about~     the size of a haricot bean)taken from underneath the skin of the belly. Subjects will record~     their food intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the~     lab for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the~     1st (screening) visit.~   "
130228|NCT01350830|"~     Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two~     anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space~     to assess any differences in term of chronic pain and early and late complications~   "
130229|NCT01350817|"~     This 2 arms study will compare the efficacy and safety of treatment with sequential~     erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients~     with recurrent non-small cell lung cancer. Patients will be randomized to receive in group~     1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per~     os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.~      The anticipated time on study treatment is until disease progression. Target sample size is~     156.~      The main of this study is to determine the relevance of the association sequential erlotinib~     and docetaxel in terms of progression-free survival .~   "
130230|NCT01350804|"~     The core and extension studies assessed the safety and efficacy of secukinumab when added to~     a background therapy in patients with active rheumatoid arthritis who are intolerant to or~     have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,~     placebo or abatacept (active comparator). The core study was completed. However, the~     extension study was prematurely terminated after the primary endpoint analysis of the core~     study at week 24 had demonstrated numerically higher efficacy for the active comparator~     abatacept compared to secukinumab.~   "
130231|NCT01350791|"~     This study is a non-randomized, prospective, open-label registry to compare the efficacy and~     safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients~     with coronary artery disease.~   "
130232|NCT01350778|"~     The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in~     the real world daily practice as compared with first-generation drug-eluting stents~     (sirolimus- or paclitaxel-eluting stents).~   "
130233|NCT01350765|"~     The present study will be carried out in close collaboration with the National Program for~     Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering~     60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional~     Birth Attendant will provide care to the mothers and newborns at household level. A Basic~     Health Unit will take care of non complicated referrals and provide injectable antibiotics~     for neonatal sepsis. Complicated (definitions given in methods section) cases will be~     referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning~     neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of~     Health, Sindh and the Federal Ministry of Health are study collaborators, therefore,~     guaranteeing scaling up of interventions at national level.~      Hypothesis:~      In comparison to a basic package of existing training program of LHWs, enhanced training of~     LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn~     infections and LBW (combined with prompt referral) will result in an additional 30%~     reduction in neonatal mortality.~   "
130234|NCT01350752|"~     The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness~     implications of interventions designed to improve health worker practice in providing~     treatment for uncomplicated malaria to febrile patients attending health facilities in~     Cameroon and Nigeria.~   "
130235|NCT01350739|"~     The aim of this study is to access to the abdominal cavity using different incision-types~     within the umbilical area.~      Effects of different incisions on scarring and on the umbilical form will be investigated.~   "
130236|NCT01350726|"~     The aims of this study were divided into three parts:~        1. To develop a new software to carry out the functional-three- dimensional-reconstruction~          of the liver by 99mTc-GSA-SPECT scintigraphy~        2. To probe a new dynamic model of the metabolism of the 99mTc-GSA.~        3. To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical~          treatment.~      Study design:~        1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.~        2. Patients: The subjects were from different hospitals including: Peking Union Medical~          College Hospital (PUMCH).~      Study arrangement:~      This study was consisted of three parts:~   "
130237|NCT01350713|"~     Skin burns are one of the causes of disability, suffering and death in humans. Anecdotal,~     uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin~     burns, provided the preparation was applied shortly after the exposure to the heat source.~     The proposed study will conduct a controlled study in which the effect of povidone-iodine~     ointment will be tested in large group of patients and will be compared with standard cold~     water treatment.~   "
130238|NCT01350700|"~     In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed~     by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of~     enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and~     not other parts of the skin).~      The burn wound, like any other wound, heals by the formation of scar at the injured site in~     order to replace the destroyed tissues. Scarring is not a static process, but rather a~     dynamic one, changing over time, especially during the first 24 months post-injury.~      Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared~     in order to evaluate the long term influence of damaged skin removal and wound care~     techniques on scar formation and maturation.~   "
131865|NCT01329224|"~     The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance~     (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our~     outpatient clinic.~   "
130239|NCT01350687|"~     Pulmonary hypertension is a new complication described in hemodialysis patients. in the last~     year these patients were treated by calcium carbonate orally to control serum phosphor.~     Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators~     want to investigate the new phosphor non calcium containing agents in hemodialysis patients~     and to measure the pulmonary pressure.~   "
130240|NCT01350674|"~     This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound~     transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal~     and/or hilar lymph nodes.~      The investigators analyse the specificity and sensibility of this technique to diagnose~     tuberculosis in mediastinal and/or hilar lymph nodes.~      Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a~     tuberculosis is the most probable cause and who have no parenchymal lesions suspected for~     tuberculosis and without other lymph nodes that are more easily accessible or palpable will~     be included in this study.~   "
130241|NCT01350661|"~     This observational study aims to assess the correlation between many questionnaires designed~     to assess the level of control of asthma. The five questionnaires will be submitted, at the~     same time and in a random order, to asthma patients. Some other parameters will be recorded~     (e.g. lung function, epidemiological data). The hypothesis is that the results of the~     questionnaires will be the same. If not, we will try to understand why.~      The investigators will include 100 patients, stratified with relation to their level of~     asthma severity (25 patients for each level of severity - described by the GINA guidelines).~   "
130242|NCT01350648|"~     Background:~      - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness,~     including liver cancer, and even death. This study will follow people who have hepatitis B~     or hepatitis C. The purpose is to understand more about how these viruses affect the immune~     system over the long term (up to 10 years). The study will also compare how these viruses~     affect people who do and do not have HIV, the virus that causes AIDS.~      Objectives:~        -  To do a long-term study of hepatitis B and hepatitis C infection.~        -  To study the effects of hepatitis B and hepatitis C infection in people do and do not~          have HIV.~      Eligibility:~      - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular~     doctor for their medical care.~      Design:~        -  Participants will be screened with a physical exam and medical history. Those who do~          not have a regular doctor to provide medical care during the study will not be able to~          take part.~        -  Participants will have yearly visits with study researchers for up to 10 years. These~          tests will be done at each visit.~        -  Medical history and physical exam.~        -  Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and~          quality of life.~        -  Blood and urine tests, including HIV testing.~        -  Tissue sample collections for those who have had a liver or other tissue biopsy.~        -  Participants may leave the study at any time. They will receive the standard of care~          from their regular doctor throughout the study.~   "
130243|NCT01350635|"~     The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins~     exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to~     grass pollen allergic patients~   "
130244|NCT01350622|"~     The primary objective of this study is to compare the pain relieving effect and speed of~     onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a~     growth curve approach to pain measurement. The investigators will test the hypothesis that~     PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The~     secondary goal of the proposed work is to discover and model the onset and course of pain~     relief during the emergency department (ED) visit.~   "
130245|NCT01350609|"~     Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence~     of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the~     corresponding loose combination under fed conditions.~   "
130246|NCT01350596|"~     An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the~     pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral~     suspension versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral~     suspension, in healthy fasting volunteers.~   "
130247|NCT01350583|"~     The purpose of this study is to:~        -  Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses~          than those usually given for heartburn.~        -  Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the~          investigators do not know for sure if these higher doses will be well tolerated or if~          they will reduce the pain associated with cancer. The investigators are doing this~          study to see if sodium bicarbonate is well tolerated and if it can reduce the~          requirements for pain medications.~   "
130248|NCT01350570|"~     This trial is to assess the effectiveness of three types of acupuncture for patients with~     functional diarrhea comparing to a positive drug control.~   "
130249|NCT01350557|"~     Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility~     problems that usually results in costly hospital stays and lengthy rehabilitation~     procedures. The purpose of this study is to compare the costs and effectiveness of three~     care models- acute/sub-acute, comprehensive, and routine care models for hip fractured~     elders in Taiwan.~   "
130250|NCT01350544|"~     The investigators hypothesize that participants in the treatment advocacy intervention will~     show significantly better HIV treatment adherence than will participants in the no-treatment~     (wait-list) control group.~   "
130271|NCT01350271|"~     Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the~     State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of~     polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is~     the only form effective against the soil-transmitted helminths. This protocol describes a~     stratified, randomized, placebo-controlled trial that examined the efficacy of different~     mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.~   "
130481|NCT01347528|"~     TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine~     the efficacy of an electronic Medication Adherence Support System (MASS) in improving and~     monitoring patients' medication adherence; to (2) i determine the effect of medication~     adherence on hospitalization and health care consumption.~   "
130251|NCT01350531|"~     To date, attempts to construct effective weight loss interventions for African American~     adolescents with obesity (AAAO) have largely failed. While effective weight loss strategies~     and skills have been identified, lifestyle changes require youth and their families to learn~     new dietary and exercise behavior with repeated skills practice in natural ecology of the~     family. A major barrier is motivation of both parents and adolescents to engage in treatment~     and to adhere to behavior change recommendations. Advances in the science of increasing~     human motivation (both intrinsic and extrinsic) that could inform intervention development~     for minority youth with obesity have been insufficiently applied to date to the process of~     intervention development. The study brings together a multidisciplinary research group~     comprised of obesity intervention researchers with extensive experience in adolescent health~     behavior change research, basic behavioral scientists with experience in motivation and~     learning research and communication scientists with experience in provider-family~     interactions within urban populations. Basic science obesity researchers will inform~     intervention development by contributing a strong background in the physiological correlates~     of obesity. Finally experts in the area of community interventions for African American~     adolescents will contribute to the effective transport of these interventions to real-world~     settings. The overarching aims of the study are: To refine intervention protocols from our~     preliminary studies that maximize adolescent and parent skills, informed by learning theory,~     through the use of home and community-based interventions in which in-vivo opportunities are~     used to promote practice in making changes in dietary, exercise and sedentary behaviors in~     AAAO and their families (PHASE I); To develop intervention protocols that utilize findings~     from basic science regarding intrinsic and extrinsic motivation to maximize adolescent and~     family adherence to recommendations for obesity-related behavior change in AAAO and their~     families (PHASE I); To develop an adaptive intervention using a sequential multiple~     randomized assignment trial (SMART design) (PHASE II); To refine the intervention including~     qualitative analysis of interviews from participant families and to develop further~     community participation in preparation for a confirmatory randomized clinical trial (PHASE~     III).~      There are two proposed hypotheses for this study:~        1. Families initially receiving home/community delivery of Motivational Interviewing~          (MI)/skills training will show greater weight loss over the course of the study than~          families receiving initial office-based delivery of MI/skills training.~        2. Non-responders receiving home/community delivery of MI/skills training with Contingency~          Management (CM) will show greater weight loss than non-responders receiving MI/skills~          training alone.~   "
130252|NCT01350518|"~     The purpose of this research study is to determine whether increased intake of dietary fiber~     during a 12-week, low-calorie weight loss intervention affects abdominal fat change and~     improves cardiovascular risk factors in African-American women more than a standard weight~     loss intervention.~      The investigators are testing two main hypothesis:~      Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly~     more abdominal fat around their organs than women in the standard fiber group.~      Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood~     pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to~     women in the control group.~   "
130253|NCT01350505|"~     To examine the change in balance that occurs in older individuals when exposed to different~     colored lights at night.~   "
130254|NCT01350492|"~     This study is intended to test the influence of weight training on physical symptoms,~     physical activity and brain structure and function in Gulf War Veterans with chronic~     widespread muscle pain.~   "
130255|NCT01350479|"~     Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and~     mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by~     health care workers. The use of gowns, gloves and hand washing prevents this spread;~     however, their use detracts from a patient-centered, home-like environment which is an~     important priority for nursing homes. The goal of this project is to determine when it is~     most important for health care workers to wear gowns and to wash their hands when caring for~     MRSA colonized Veterans in community living centers.~   "
130256|NCT01350466|"~     The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune,~     infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus~     surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients~     that undergo FESS, need revision surgery within the 3 years following initial surgery.~     Causes of failure are multiple and not fully understood.~      As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients~     with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology~     induced by occupational factors as well. No data are currently available on how these~     factors may contribute to the disease manifestation, whereas negligence of these factors as~     potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the~     mucosal condition and even give rise to the induction of bronchial symptoms. There exists no~     documentation on the role of the occupational agents on chronic sinus disease.~      This prospective study aims at providing data about the exposure levels of patients that~     undergo sinus surgery and correlate them with both subjective and objective postoperative~     parameters. This will be done by providing a questionnaire that was developed at our~     department to all patients that are planned for sinus surgery at the participating centers.~     This questionnaire asks for medical history, current sinonasal symptoms, professional~     history and recreational occupation. An extensive list of occupational agents is given and~     patients are asked to indicate those that they encounter at work or during recreational~     activities. This will be followed by an extensive clinical investigation including nasal~     endoscopy. These investigations (questionnaire and clinical examination) will be repeated at~     3 months and 12 months after surgery.~   "
130257|NCT01350453|"~     When a person has had a stroke they often lose their confidence, motivation and the ability~     to move one arm and hand. Recent research has shown that intensive exercise assists recovery~     of movement, but people are often discouraged by slow progress and stop using their weak~     limb.~      A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this~     habitual 'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a~     day to prevent it from being used. Use of the weak arm and hand is encouraged by intensive~     exercises. CIT is not available in the NHS because of lack of therapist time for supervision~     and patients lack the confidence and motivation to carry out CIT alone at home.~      This study will have two stages.~      Stage 1.~      The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to~     support patients carrying out CIT at home (with their carer where possible) with online~     therapist support. The investigators will develop the therapy programme working closely with~     at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.~      Stage 2~      The investigators will then carry out a pilot trial in three centres with 40-60 patients who~     have just been discharged from hospital and who have loss of arm and hand function. To test~     LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT~     intervention or usual care. A researcher, who doesn't know which group patients have been~     allocated to, will measure their arm and hand function, record the problems this causes and~     how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6~     months later. The investigators will also examine the cost-effectiveness of treatment and~     ask both therapists and patients for their views.~   "
130258|NCT01350440|"~     This is a preliminary study to determine the safety and efficacy of intravenous immune~     globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in~     clinical measures of disease severity before and after treatment.~   "
130259|NCT01350427|"~     This study aims to evaluate the effects of leucine and branched-chain amino acids~     supplementation on skeletal muscle remodeling signaling pathways induced by resistance~     exercise.~   "
130308|NCT01349790|"~     NewGam is a newly developed human normal immunoglobulin solution for intravenous~     administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in~     patients with primary immune thrombocytopenia.~   "
130260|NCT01350414|"~     The objective of this study is to evaluate durability of effectiveness (beyond one year) of~     the Alair System in patients with severe persistent asthma. The study will consist of~     Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2~     Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).~      Durability of the treatment effect will be evaluated by comparing the proportion of subjects~     who experience severe exacerbations during the first year after Alair treatment with the~     proportion of subjects who experience severe exacerbations during subsequent 12 month~     periods out to 5 years.~      All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2~     Trial protocol. The data that are to be used to determine durability of effectiveness as~     described in the present protocol (Protocol #10-01) are being collected under the existing~     AIR2 Trial protocol (Protocol # 04-02).~      Study Hypothesis: An empirical demonstration of the durability of the treatment effect will~     be used to show that the proportion of subjects experiencing severe exacerbations for the~     first year compared with the proportions of subjects experiencing severe exacerbations in~     subsequent years do not get substantially worse.~      The primary statistical objective is to demonstrate that the proportion of subjects who~     experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3,~     Year 4 and Year 5 [in 12-month periods]) is not statistically worse when compared with the~     proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This~     objective will be met if the upper 95% confidence limit of the difference in proportions~     (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than~     20%.~   "
130261|NCT01350401|"~     The purpose of this early (phase I/II) clinical trial is to assess the effects (both good~     and bad) of genetically modified T cells after chemotherapy on your cancer and general~     health.~   "
130262|NCT01350388|"~     Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic~     syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia~     induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of~     uric acid with febuxostat it is hypothesized that the levels of oxidative stress in adipose~     tissue (obtained by fat biopsy) will decrease.~      Primary aims of the study are to determine whether febuxostat therapy in overweight or~     obese, diabetic patients with stage 3 Chronic Kidney Disease (CKD) and high serum uric acid~     levels~        1. will affect adipose tissue concentrations of thiobarbituric acid reactive substance~          (TBARS), a marker of oxidative stress~        2. will affect adipose tissue expression and concentrations of adiponectin; and~        3. will affect urinary concentrations of transforming growth factor (TGF)- B1.~   "
130263|NCT01350375|"~     This study will investigate the therapeutic utility of BOTOX in reducing the degree of~     Forward Head Posture (FHP) with associated headache and myofascial pain, decreasing the~     frequency of headache, and improving the overall quality of life.~   "
130264|NCT01350362|"~     The main purpose of this study is to evaluate the cognitive changes after administration of~     tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in~     patients with mild to moderate Alzheimer's disease.~      After the 26 week core treatment period, the patients may continue in the study under~     blinded conditions for an optional extension period up to a maximum of 39 additional weeks~     (total study duration up to 65 weeks), until the last patient in the study has completed the~     26 week of treatment.~   "
130265|NCT01350349|"~     Among older adults the combination of depression, cognitive impairment (memory problems),~     and disability contribute to a worsening of physical and mental health and to poor treatment~     outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems~     achieve remission from their depression. Interventions involving talking therapy are~     underdeveloped and understudied. Therefore, this research study will test the efficacy of~     Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders~     with major depression, memory problems, and disability. PATH focuses on the subject's~     ecosystem (the patient, the caregiver, and the home-environment) and targets behavioral~     problems related to both depression and disability.~      PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most~     of their difficulties. Local Home Delivered Meals programs will refer clients who have~     symptoms of depression and are interested in research. All participants will have an~     available caregiver (family, significant other, or professional) and will be randomized to~     12 weekly sessions of PATH or Supportive Therapy, the current standard of care for talking~     therapy. The study will test whether home-delivered PATH is more effective than~     home-delivered Supportive Therapy in reducing the subjects' depression and disability and in~     increasing self-efficacy over the 12-week treatment period.~   "
130266|NCT01350336|"~     As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston~     Scientific to generate data to assess the durability of the BT treatment effect as well as~     safety data in the intended use population in the United States.~   "
130267|NCT01350323|"~     This is a pilot, prospective, interventional, case-control study investigating aqueous~     levels of vascular endothelial growth factor (VEGF) in eyes with AMD-related~     neovascularization treated with intravitreal bevacizumab at the Medical Retina Department,~     University of Molise, Campobasso.~   "
130268|NCT01350310|"~     BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell~     transplantation has been shown to improve exercise capacity, reduce ventricular remodelling~     and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the~     diseased heart can be further enhanced by direct intramyocardial delivery route.~      AIMS.~        1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with~          non-ischemic dilated cardiomyopathy.~        2. To directly compare clinical effects of intracoronary and intramyocardial stem cell~          delivery.~      METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to~     intramyocardial transplantation of CD34+ cells (Study Group), and 30 will receive~     intracoronary stem cell therapy (Control Group). In both groups peripheral blood stem cells~     will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be~     collected via apheresis and labelled with technetium. In the Study Group electromechanical~     mapping will be used to identify viable myocardium and intramyocardial injections in the~     target areas will be performed with NOGA catheter. In the Control group patients will~     undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in~     the artery supplying segments of reduced viability. Patients will be followed for 1 year.~     Primary endpoints will include changes in left ventricular ejection fraction and left~     ventricular dimensions (measured by echocardiography). Secondary endpoints will include~     changes in exercise capacity and changes in NT-proBNP values.~      HYPOTHESES.~        1. At 1 year, intramyocardial stem cell therapy will be associated with improved left~          ventricular ejection fraction, reduced left ventricular dimensions, improved exercise~          capacity and reduced levels of NT-proBNP.~        2. Beneficial effects of intramyocardial stem cell therapy will be superior to those~          observed with intracoronary stem cell delivery.~   "
130269|NCT01350297|"~     This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in~     tetraplegic patients with ventilatory insufficiency.~   "
130272|NCT01350258|"~     This is a research study involving the treatment of patients with hematological cancers with~     allogeneic (cells from a donor) hematopoietic stem cell transplant (HSCT). HSCT is often~     referred to as bone marrow transplant. Patients who are not expected to have long term~     survival after conventional therapy will undergo HSCT as a curative therapy after receiving~     front line therapy for their disease. This project is based on an HSCT approach that has~     been used at TJU since 2006 with the goal of optimizing this type of treatment further. In~     this new study, the investigators will substitute the chemotherapy agent, Melphalan (Mel),~     for cyclophosphamide (CY). Cyclophosphamide was used in the original trial. The research~     question is whether side effects are less using Mel and if donor T cells can be made~     tolerant to the recipient with the use of Mel. The proposed study is also more specific in~     terms of performance status and organ function entry criterion. The investigators observed~     in the original trial that patients with poor performance upon admission for transplant did~     not have as good outcomes.~      Because many older patients are treated according to this type of transplant, the~     chemotherapy and radiation used are less intensive than other types of transplant. The name~     for this in the transplant field is a reduced intensity hematopoietic stem cell transplant.~     The abbreviations most used in this document are RIC for reduced intensity conditioning,~     HSCT which refers to the transplant itself, and MEL which refers to the drug, Melphalan.~   "
130273|NCT01350245|"~     The primary hypothesis of this research study is that patients in remission undergoing~     myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas~     Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS)~     rate at 1 year that is the same or better than the historical DFS of patients with similar~     diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a~     DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative~     therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step~     approach over T-replete matched sibling HSCT.~   "
130274|NCT01350232|"~     This is a clinical research trial in which a novel preparatory regimen was developed for~     bone marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack~     of a matched sibling donor. It is believed this regimen is sufficiently efficacious and~     sufficiently gentle to apply to patients with sickle cell anemia and related disorders. It~     is proposed to characterize the efficacy and toxicity of this regimen in high risk patients~     with sickle cell anemia using criteria for patient selection that have been accepted in~     prior BMT trials in patients with sickle cell disease, specifically only the subset of~     patients whose prior clinical behavior indicates that they are at high risk for serious~     morbidity and early mortality. In addition, it is proposed to characterize the~     pathophysiology of a consistent febrile response seen in the haploidentical BMT regimen the~     investigators have developed at Thomas Jefferson University (TJU).~      The primary goal of this study is to determine the response rate to a reduced intensity~     conditioning regimen which consists of fludarabine, cytarabine, low dose total body~     irradiation and cyclophosphamide in patients with severe sickle cell anemia.~   "
130275|NCT01350219|"~     The translational potential to the clinical applications of cord blood stem cells has~     increased enormously in recent years, mainly because of its unique advantages including no~     risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid~     availability, and large resource worldwide. Human cord blood contains several types of stem~     cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess~     multiple biological properties including the expression of embryonic stem (ES) cell~     characteristics, giving rise to different types of cells and immune modulation.~     Specifically, CB-SC can function as an immune modulator that can lead to control of the~     immune responses, which could in turn be used as a new approach to overcome the autoimmunity~     of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the~     investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the~     therapeutic effectiveness of Educator therapy in T1D patients.~   "
130276|NCT01350206|"~     The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is~     still controversial, and there is no universally agreed protocol for its treatment.~     Transarterial chemoembolization (TACE) has become the most popular palliative treatment for~     patients with unresectable HCC, and it is no longer considered as a contraindication to HCC~     with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with~     TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still~     offer a chance of cure. With advances in surgical techniques, it has become feasible to~     remove all gross tumors, including PVTT which has extended to the main portal vein, safely~     by surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE~     to treat patients with HCC with PVTT. The investigators also aimed to identify patient~     groups that might benefit more from either treatment with HR or TACE.~   "
130277|NCT01350193|"~     All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS)~     or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included~     in the study.~      All participants enrolled in the study will receive antibiotic (Clavulin) therapy 1-week~     pre-and post-operatively and oral steroid therapy 1-week pre-operatively and~     post-operatively.~      Randomization of patients to the Manuka Honey irrigation (treatment arm) and Saline~     irrigation (standard of care) will occur on the day of surgery.~      Participants in both study arms will undergo the standard post-operative endoscopic sinus~     surgery follow-up. This includes follow-up appointments at 6 days, 5 weeks, 3 months, and 6~     months of the post-operative period. During these appointments, the surgeon will assess the~     post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain,~     and 1st week post-operative bleeding (only at 6 day visit).~      The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study~     participants at 6 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a~     5-minute questionnaire consisting of 22 questions, which asks participants to rate their~     sinus symptoms and social/emotional consequences of their nasal disorder from no problem~     to problem as bad as it can be.~   "
130309|NCT01349777|"~     This study is an open label, multi-center, randomized trial, which is designed to evaluate~     the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in~     patients undergoing PCI compared to conventional clopidogrel (Plavix®).~   "
130278|NCT01350180|"~     One of the biggest problems facing prostate cancer patients and their treating physicians is~     who needs to be treated and when. Common clinical and pathological parameters are useful~     (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and~     who will fail. Genetic markers for tumor aggressivity would be of greater value. The finding~     that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression~     is important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family~     of proteins which have a role in controlling cell growth, cell specialization and producing~     tumors. As a consequence of this gene fusion, production of the ERG protein increases in the~     presence of testosterone and could be key to the development of prostate cancer, resistance~     to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor.~     Its deletion is a contributing factor in the development of prostate cancers and poor~     outcome. The coexistence of the two markers could be associated with a higher risk of~     recurrence.~      To date there have been no studies regarding the presence of either of these two markers or~     their coexistence in high risk prostate cancer patients who, despite radiation therapy and~     androgen suppression, develop biochemical failure (their PSA levels rise once again).~     Patients participating in the PCS IV study (high risk prostate cancer treated with radiation~     therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical~     failure or 3 years of follow-up post hormonal therapy will be approached.~      Tumor blocks from consenting patients will be collected and analyzed for the presence of the~     TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish~     General Hospital. Statistical analysis will be carried out to see whether either or both~     markers are present, whether they are associated with certain clinical and pathological high~     risk factors, and whether they can be used to predict which patients will fail treatment.~   "
130279|NCT01350167|"~     The purpose of this study is to determine whether ultrasound or CT scanning is more~     effective at detecting early liver cancer in patients with advanced liver disease.~   "
130280|NCT01350154|"~     This study is done to evaluate whether treatment with the drug sildenafil (Revatio®) can~     improve muscular, cardiac, cerebrovascular or cognitive function in patients with Beckers~     muscular dystrophy when compared to placebo (inactive medication). The study is based on the~     recent findings of an improved cardiac function in a mouse model of muscular dystrophy~     (Adamo et al 2010) and the previous findings of changed cognitive function in people with~     Becker dystrophy.~      In muscular dystrophy, the cellular protein, dystrophin is affected. During normal~     conditions, the enzyme neuronal nitric oxide synthase (nNOS), which produce nitric oxide~     (NO), is attached to dystrophin. NO is important in normal vascular function in each of~     muscle, heart and brain by stimulating production of cyclic GMP. However, in muscular~     dystrophy with dystrophin deficiency, nNOS do not have the normal cellular anchor, resulting~     in decreased NO levels and subsequent reduced cyclic GMP production. Sildenafil inhibits~     degradation of cGMP thus prolonging and increasing a cGMP response. Such effects are the~     basis for use of sildenafil in pulmonary hypertension and erectile dysfunction. Current~     hypothesis: Sildenafil restores the cyclic GMP function affected in muscular dystrophy wit~     nNOS deficiency resulting in improved muscle, cardiac, cerebrovascular and cognitive~     function.~   "
130281|NCT01350141|"~     PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this~     study to evaluate if it can lower LDL cholesterol.~   "
130282|NCT01350128|"~     The overall objective of this study is to determine an optimal dose and dosing regimen of~     PT001 MDI for further evaluation in later stage studies.~   "
130283|NCT01350115|"~     This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial~     evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult~     patients with NBCCS. This was an exploratory study designed to demonstrate preliminary~     efficacy of LDE225 in this indication. This study included a Screening period of~     approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of~     approximately 6-8 weeks followed by a long-term follow-up period.~   "
130284|NCT01350102|"~     The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic~     wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health~     Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will~     be done to evaluate impact on time to wound closure.~   "
130285|NCT01350089|"~     The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks~     has an effect on perceived alcohol intoxication.~   "
130286|NCT01350076|"~     The objectives of this study are 1) to investigate the influence of different fluid regimen~     (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as~     weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of~     USCOM monitoring using serum lactate and base deficit as control parameters.~   "
130287|NCT01350063|"~     When shallow tubewells replaced highly contaminated surface water as the primary source of~     drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no~     reduction in diarrheal disease with this improvement in water source. This lack of~     improvement in transitioning to tubewells is consistent with the lack of significant health~     gains observed in intervention studies focusing on water quality improvements at the source.~     In contrast, high quality intervention studies that improve water quality at the point of~     use through treatment of water in households show a 39% reduction in diarrhea.~      The primary objective of this study is within a typical setting in rural Bangladesh where~     households use shallow tubewell water for drinking. The investigators will randomly assign~     1800 households who have a child between the ages of six months and two years to one of~     three groups. Group 1 will receive a safe water storage vessel with a lid and a narrow~     mouth/tap and Aquatabs, an effervescent water purification tablet that utilizes sodium~     dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water~     storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention~     and continue their standard habits and practices. Every month a field research assistant~     will visit each participating household and collect information on the prevalence of~     diarrhea among children between the ages of six months and two years, as well as children~     between the ages of two and five years if present in the household. Diarrhea prevalence in~     the 48 hours and 7 days preceding the visit will be recorded. The investigators will compare~     the longitudinal prevalence of diarrhea between the following groups: (1) households that~     receive chlorine and storage container versus households that only receive storage container~     to assess the effect of chlorination, (2) households that only receive storage container~     versus households that receive no intervention to assess the effect of safe storage, and (3)~     households that receive chlorine and storage container versus households that receive no~     intervention to assess the combined effect of chlorination and safe storage.~      Hypothesis:~      Drinking water from shallow tubewells that are intermittently contaminated with enteric~     pathogens contributes importantly to diarrhea among children in rural Bangladesh.~   "
130288|NCT01350050|"~     Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is~     local anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper~     endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to~     placebo (Na0,9%) during gastroscopy in terms of benefit on patients` and endoscopists`~     satisfaction.~   "
130289|NCT01350037|"~     Self-administration of propofol and opioid mixture by the patient him- or herself~     (patient-controlled sedation, PCS) could be successful alternative to the~     anesthesiologists-managed deep sedation during endoscopic retrograde~     cholangiopancreatography (ERCP). However, it is not known which opioid would be the most~     suitable for PCS. The aim of this double-blind study was to compare remifentanil and~     alfentanil in PCS during ERCP.~   "
130519|NCT01347034|"~     The purpose of this study is to determine if injection of the participant's our own immune~     related white blood cells (called dendritic cells) into their tumor will strengthen their~     immune system to fight against their cancer.~   "
130290|NCT01350024|"~     Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a~     posterior approach. Patients who undergo this procedure are often given local anesthesia to~     alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal~     nerve block or subconjunctival injection combined with sedation in most cases. Both~     techniques are currently acceptable options for local anesthesia, however postoperative pain~     has not been systematically evaluated between these two techniques.~      The investigators aim to compare intra-operative and postoperative pain with these two~     techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will~     be randomized to receive local anesthesia via frontal nerve block or via subconjunctival~     injection. In addition, the investigators will measure the surgical outcomes of the ptosis~     surgery with standard measures.~   "
130291|NCT01350011|"~     Drug addiction treatment patients, including those in treatment for opioid dependence, have~     a high rate of tobacco dependence, especially cigarette smoking. The proposed study~     evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of~     opioid treatment patients, those in buprenorphine maintenance. The specific aims of the~     study are to test the efficacy and the cost effectiveness of the IS.~      A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs~     between participants who achieve abstinence from cigarettes during the study, and those who~     do not.~   "
130292|NCT01349998|"~     The purpose of this study is to examine the long-term safety of treating recurrent episodes~     of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or~     tinea cruris for 7 days for each recurrence with Product 33525.~   "
130293|NCT01349985|"~     Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE,~     which uses the text messaging and internet capabilities of modern cellular phones to address~     the problem of medication adherence in clinical care and clinical trial contexts. This trial~     will evaluate whether AGATE improves medication adherence in the context of a~     pharmacotherapy trial of naltrexone to treat problem drinking. All participants will be~     treatment-seeking problem drinkers who will receive naltrexone and medication monitoring~     over 8 weeks.~   "
130294|NCT01349972|"~     This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone~     hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating~     patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether giving alvocidib, cytarabine, and~     mitoxantrone hydrochloride is more effective than giving cytarabine and daunorubicin~     hydrochloride in treating patients with acute myeloid leukemia.~   "
130295|NCT01349959|"~     This phase II trial studies how well giving azacitidine and entinostat work in treating~     patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill~     more tumor cells.~   "
130296|NCT01349946|"~     Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2~     (DEFUSE 2) is a multi-center pilot study to determine if cerebral perfusion imaging can help~     identify which patients, who are ineligible for intravenous tissue plasminogen activator (iv~     tPA) therapy or have failed iv tPA therapy, are most likely to benefit from an endovascular~     clot removal procedure.~   "
130297|NCT01349933|"~     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients~     with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
130298|NCT01349920|"~     This study will evaluate biomarkers that reflect changes in gut mucosal status during~     therapy with infliximab and determine whether changes in the levels of the selected~     biomarkers can be used to predict endoscopically assessed gut mucosal status changes.~   "
130299|NCT01349907|"~     This study will investigate the safety and tolerability of a flexible dosing regimen of~     asenapine for the long-term treatment of manic or mixed episodes associated with bipolar~     disorder I in children and adolescents who completed study P06107.~   "
130300|NCT01349894|"~     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care~     System for the treatment of skin cancer excision sites and split thickness skin grafts~     (STSG). The secondary purpose will be to compare the prospective patients to retrospectively~     treated skin cancer excision sites and STSGs to further evaluate efficacy and safety.~   "
130301|NCT01349881|"~     The investigators hypothesize that the combination of eflornithine and sulindac will be~     effective in reducing a three-year event rate of adenomas and second primary colorectal~     cancers in patients previously treated for Stages 0 through III colon cancer.~   "
130302|NCT01349868|"~     The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI~     compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
130303|NCT01349855|"~     Primary Objective:~      To assess the safety and tolerability of two dose levels of a new insulin glargine~     formulation in a once-daily multiple dosing regimen~      Secondary Objective:~      To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new~     insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen~   "
130304|NCT01349842|"~     Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of~     chemotherapy for metastatic breast cancer.~   "
130305|NCT01349829|"~     This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides~     protection that is non-inferior to the protection afforded by vaccination with Havrix 720~     Junior.~   "
130306|NCT01349816|"~     The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its~     individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
130307|NCT01349803|"~     This study is primarily a safety study. The primary and secondary endpoints are based on~     24-hour Holter monitor assessments obtained on Day 14 relative to baseline.~   "
130310|NCT01349764|"~     When Vitamin D replacement is initiated in patients with history of urolithiasis, there will~     be higher incidence of hypercalciuria but with careful follow-up of these patients,~     hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of~     newly diagnosed renal stones will be equivalent to control groups without Vitamin D~     replacements.the purpose of the study is to determine the effect of vitamin D replacement in~     patients with previous history of urolithiasis presenting to a tertiary stone clinic in~     terms of changes in 24-hour urine collection parameters and to evaluate the lithogenic~     effect of vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible~     patients will be included in terms of having suboptimal vitamin D with history of calcareous~     urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided~     into 2 equal groups depending on whether they will receive vitamin D replacement with~     follow-up at 3, 6, 12, & 24 months.~   "
130311|NCT01349751|"~     The authors would like to investigate the blocking characteristics, surgical quality and~     side effects of intrathecal levobupivacaine whether there are any differences between the~     hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block~     level than the urological surgeries.~   "
130312|NCT01349738|"~     The goal of this research program is to understand the natural history of asymptomatic~     bacteriuria in the renal transplant patients, to determine if screening for asymptomatic~     bacteriuria and identification of key host characteristics and virulence factors present on~     uropathogenic bacteria identifies a sub-population of patients with asymptomatic bacteriuria~     that are at risk to develop symptomatic urinary tract infection. Ultimately, the knowledge~     obtained from this study will prevent inappropriate antibiotic use and may identify whether~     certain bacterial isolates predispose to renal allograft injury. We will test the hypothesis~     that (i) asymptomatic bacteriuria is common in the renal allograft recipient and (ii) that~     symptomatic urinary tract infection and renal allograft dysfunction do not occur unless key~     host susceptibility factors and uropathogenic bacterial virulence factors are present.~   "
130313|NCT01349725|"~     This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of~     investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects~     from the United States will be enrolled in this study.~   "
130314|NCT01349712|"~     The purpose of this study is to measure prothrombin time (PT) on an experimental device and~     a commercially available device on persons receiving coumadin (warfarin)treatment.~   "
130315|NCT01349699|"~     Iron affects immunity. However, the exact effect of iron on the innate immune response is~     not known. Animal data suggest that iron administration induced oxidative stress which~     enhances the innate immune response, whereas iron chelation has the opposite effect. The~     investigators tested the hypothesis that administration of iron sucrose 1.25 mg/kg augments~     the innate immune response, and iron chelation by deferasirox 30 mg/kg attenuates the innate~     immune response during human experimental endotoxemia.~   "
130316|NCT01349686|"~     Fasting during labour is a usual conduct in many hospitals around the world (due to the~     theorical risk of bronchoaspiration). There is little evidence supporting this conclusion.~     Besides, there are several studies that suggest that food intake during labour can be~     associated with shorter labours and a lower cesarean rate. The aim of the investigators~     study is to show if the oral intake of fluids during labour can reduce the first stage of~     labour with minimum risk to the patient.~   "
130317|NCT01349673|"~     The purpose of this study is to evaluate safety and tolerability of cyclically dosed rectal~     budesonide foam in subjects with active ulcerative proctitis (UP) or ulcerative~     proctosigmoiditis (UPS).~   "
130318|NCT01349660|"~     In this phase I/II study,investigators are evaluating the feasibility and efficacy of the~     combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of~     patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120~     dose to be administered with a standard dose of bevacizumab will be determined in patients~     with refractory solid tumors. Although it is unlikely that the concurrent administration of~     bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will~     be performed on all patients treated during the Phase II portion of the study. Assuming this~     combination is feasible, the Phase II portion of the study will proceed, using the doses~     determined in the Phase I portion. In the phase II portion, eligible patients will be~     limited to those with recurrent/progressive GBM following 1st line combined modality~     therapy.~   "
130319|NCT01349647|"~     Even when small cell lung cancer responds well to treatment with chemotherapy, it has a~     tendency to grow back and to spread. The investigators are interested in testing new~     therapies aimed at decreasing this risk. This study tests a vaccine, which is a substance~     injected under the skin which can cause an immune response. The hope is that the body will~     make antibodies to the vaccine which will also react against the cancer. The vaccine is~     specific for small cell lung cancer. It combines several components (small cell lung cancer~     targets) that have been tested individually in patients with small cell lung cancer or other~     cancers (GD2, GD3, Globo H, Fucosyl GM1 and N-propionylated polysialic acid). Two other~     substances (KLH and OPT-821) are added which boost the immune system.~      This study will have two groups of patients. The first group will receive the vaccines along~     with one cycle of chemotherapy. The second group will receive the vaccines without~     chemotherapy.~   "
130330|NCT01349504|"~     Hypothesis:~      Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory~     Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in~     patients with IBD. These factors can be identified using qualitative testing in order to~     develop a validated instrument to measure the adherence profile of an individual patient,~     and design appropriate behavioral interventions to reduce non-adherence.~      Objectives:~      To test a novel interview instrument that determines the medication adherence profile of~     patients with IBD prescribed mesalamine by correlating with objective measures of adherence~   "
130331|NCT01349491|"~     The investigators hypothesize that ranolazine would decrease the incidence of recurrence of~     Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with~     persistent AF who are candidates for electrical cardioversion will be randomized to either~     placebo or ranolazine after successful electrical cardioversion.~   "
130520|NCT01347021|"~     The purpose of this study is to compare the vaginal sacrospinous colpopexy and high~     uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with~     uterus.~   "
130320|NCT01349634|"~     Many school children in Ethiopia and their mothers are known to be iodine deficient.~     Prevalence in the Amhara region is around 29%. Micronutrient Initiative, a development~     organization based in Ottawa, plans to help iodize the salt by providing iodization machines~     and iodine to the salt producers in Lake Afdira where salt is produced and distributed to~     the population of Ethiopia. Although it is generally assumed that iodine is important for~     cognitive development, very few studies examining the effects of iodized salt have been~     conducted. Studies using a single dose of iodine capsules with children 6 to 12 years showed~     mixed outcomes with approximately 25% yielding positive outcomes for the intervention~     children. Sixty districts in Amhara will be randomly selected and randomly assigned so that~     half receive early delivery of iodized salt. Approximately 6200 mothers and their children~     6-, 18-, or 60-months old will be recruited from 1-2 villages in each of the 60 districts,~     with the help of government-paid Health Extension Workers, for a 12-mo longitudinal study~     starting in May 2011, prior to the introduction of iodized salt. These same mothers and~     children will be visited 12 months later for repeated measures. Measures include nutritional~     status such as height and hemoglobin, along with iodine sufficiency (e.g., goitre, urinary~     iodine, thyroglobulin), and child development (Bayley Scales of Infant and Toddler~     Development III, Wechsler Preschool and Primary School Intelligence test for older~     children). Comparisons will be made within and between groups to determine whether iodized~     salt has an effect on children's mental development.~   "
130321|NCT01349621|"~     This is a prospective study to compare unpolarized (conventional) to polarized light~     colposcopy. Subjects will be asked to participate in the study when they arrive for their~     prescheduled colposcopic examination. The study doctor will use a conventional or standard~     colposcope to perform the examination. His/her impression of the exam will be noted and if~     necessary a biopsy specimen will be obtained. The study doctor will then perform a~     colposcopy using a polarized light. His/her impression of the exam will be noted and a~     biopsy specimen will be obtained if necessary.~      This study is designed to test the hypothesis that polarized light colposcopy is more~     sensitive and more specific than standard, un-polarized light colposcopy.~   "
130322|NCT01349608|"~     This study is designed to explore a new approach to help people with chronic obstructive~     pulmonary disease (COPD) become more physically active. Through weekly telephone sessions~     with a health coach utilizing motivational interviewing, participants will be empowered to~     set goals for increased physical activity (emphasis on walking). The objective of the study~     is to determine if telephone-based health coaching is a reasonable and effective way to~     increase physical activity, as measured by a gold-standard activity monitor, in people with~     COPD.~   "
130323|NCT01349595|"~     The purpose of this study is to see if treating patients who have high levels of donor~     specific alloantibodies post-transplant with bortezomib might prevent the development of~     transplant glomerulopathy and preserve allograft function.~   "
130324|NCT01349582|"~     Flow diverters are a recent addition to the range of endovascular devices now available for~     the treatment of intracranial aneurysms. The FIAT trial aims at comparing flow diversion to~     best standard treatment in the context of a randomised controlled trial. Best standard~     treatment may include any of the following and will be left to the treating physician to~     decide : 1) conservative management; 2) coiling with or without high porosity stenting; 3)~     parent vessel occlusion with or without bypass; 4) surgical clipping. If the only treatment~     alternative is deemed to be flow diversion for compassionate use, then randomisation will~     not be carried out, but patient will enter a registry and her data recorded according to~     same schedule as randomised patients.~      The primary hypothesis is that flow diversion can be performed with an acceptable~     immediate complication rate, defined as less than 15% morbidity and mortality, AND increase~     the number of patients experiencing successful therapy, defined as complete or near complete~     occlusion of the aneurysm from 75 to 90%, relative to best standard treatment.~   "
130325|NCT01349569|"~     This research is being done to find out if the investigators can improve outcomes for~     multiple myeloma patients by giving a myeloma vaccine to patients who are already on~     lenalidomide (Revlimid) and in a near complete remission.~   "
130326|NCT01349556|"~     This research is being done to study whether using of topical tretinoin can help prevent the~     common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I)~     medications such ascetuximab or erlotinib.~      Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on~     their face, chest, and other areas. This rash from EGFR-I's is often treated with~     moisturizers and topical or oral antibiotics. However, there has not yet been a study~     looking at a way to prevent this common side effect from occurring, and topical tretinoin~     may be useful in reducing the rash.~      Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the~     treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing~     rashes associated with EGFR-I's.~   "
130327|NCT01349543|"~     The aim of this study is to understand the immune response (how the body fights infection)~     to Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold'~     illness in healthy adults, but can cause wheezing and lung problems in young infants and the~     elderly. The investigators want to understand why this is, in order to develop vaccines and~     treatments.~      Participants will include 30-40 healthy adults age 18-55 years. Study procedures will~     include brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of~     fluid (lavage) and cells from the nose, throat and lungs. All participants will receive the~     virus via drops in the nose. The duration of the study for all subjects will be 6 weeks.~   "
130328|NCT01349530|"~     Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de~     France) on monitoring and management of patients treated with VKAs compared with usual~     primary care.~      Study hypothesis: The investigators suppose that patients will have a better quality of~     anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)~   "
130329|NCT01349517|"~     The purpose of this multi-center prospective cohort study is to study the health-related~     quality of life (HRQL) together with other outcomes of patients with esophageal cancer after~     surgery in China.~   "
130332|NCT01349478|"~     The purpose of this study is to determine whether a three times per week, 2 month robotic~     assisted treadmill gait training program, will beneficially affect the fitness, physical and~     psychological well-being, and the vascular and metabolic cardiovascular risk factors in~     individuals with complete motor Spinal Cord Injury (SCI).~   "
130334|NCT01349452|"~     Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of~     herpetic keratitis and shows potential for effectiveness against other viral ocular~     infections. The majority of adenoviral conjunctivitis will resolve without damaging vision,~     however, the investigators have no way to determine which cases will progress to ocular~     complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate~     the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after~     adenoviral conjunctivitis.~   "
130335|NCT01349439|"~     The purpose of this study is to test whether propranolol is capable of reducing subsequent~     physiological trauma-related conditioned responses, as well as self-reported post-traumatic~     stress disorder (PTSD) symptoms.~   "
130336|NCT01349426|"~     Surgical staplers have become standard for ligation, division, resection, anastomosis and~     closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for~     pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition,~     closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally~     safe and efficacious, staplers and staple loads are expensive, and can result in micro air~     leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less~     expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination~     of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature~     the collagen and elastin in tissue and blood vessels. The newly released Force Triad~     Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may~     offer improved performance in terms of tissue sticking due to an improved sealing algorithm,~     and to the jaw configuration of the Impact. The study main objective is to compare the~     quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that~     achieved with LigaSure.~   "
130337|NCT01349413|"~     Background:~      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of~     functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the~     first line treatment for functional dyspepsia. However, the results on effectiveness of PPI~     are conflicting and it has been suggested that PPI is only effective for acid-related~     symptoms.~      The investigators plan to use a wireless pH monitoring system positioned at the junction of~     esophagus and stomach to evaluate the chronological relationship between acid exposure at~     this region and symptoms of dyspepsia as well as its impact on the efficacy of acid~     suppressive therapy in treatment of functional dyspepsia.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims:~        1. To evaluate the chronological relationship between acid exposure at squamo-columnar~          junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia~        2. To evaluate the relationship between acid exposure at squamo-columnar junction and~          dyspeptic symptom response to PPI~        3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients~      Study medication:~      Esomeprazole 20mg vs Placebo o.d.~      Study design:~      Double-blind randomized placebo-controlled trial~      Number of subjects: 130~      Patient population:~      Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)~      Duration of study:~      1 June 2010 - 30 May 2012~      Primary variable(s):~      Proportion of patients who report positive response to adequate relief of dyspeptic symptoms~     at week 8~      Secondary variable(s):~      Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation~     to esophageal pH of less than 4 as measured at 1 cm above SCJ.~      Number of visits: 2~      Hypothesis:~      Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment~     response to PPI in FD patients without concomitant GERD~   "
130338|NCT01349400|"~     Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic~     incisional hernias in terms of pain and discomfort during normal activities.~   "
130339|NCT01349387|"~     Main objective : Show that treatment with metformin in patients with type 2 diabetes has an~     effect on alternative splicing of the insulin receptor.~      Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with~     discontinuation of treatment with metformin can be réversé by the resumption of metformin~     treatment.~   "
130340|NCT01349374|"~     The main objective of this study is the Obtention of skin micro-samples collected from~     healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards~     to obtain stem cell lines, in the framework of new therapeutic strategies of type 2~     diabetes.~   "
130341|NCT01348386|"~     BACKGROUND:~      Molluscum contagiosum is a non-serious children viral infection. Because of its natural~     history, being highly contagious and the aesthetic and psychotherapeutic effects of its~     treatment, the investigators intend to test the use of different concentrations of potassium~     hydroxide solution in the primary care setting.~      METHODS:~      A double blind, randomized clinical trial, in three groups of topic treatment is designed.~     The intended treatment consists on a daily application of potassium hydroxide in aqueous~     solution at 10% and 15% concentration, versus a placebo administered to the control group. 4~     follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness~     and tolerance.~      The main target of the trial is to determine the healing rate, defined as lesion~     disappearance in the affected zones after the topic application of the treatment. Secondary~     targets are the main characteristics and evolution of the affected zone (surface, number of~     lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching,~     burning, pain), recurrence rate estimation and natural evolution of lesions in the control~     group.~   "
130342|NCT01348373|"~     The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated~     stent in patients with STEMI with other drug-eluting stents (DESs).~   "
130343|NCT01348360|"~     The objective of this study is to evaluate effectiveness and safety of Nobori stent in the~     real world daily practice as compared with first-generation drug-eluting stents~     (sirolimus- or paclitaxel-eluting stents).~   "
130344|NCT01348347|"~     This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib~     in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose~     (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1~     (Plk1) inhibitor in advanced cancer patients.~   "
130345|NCT01348334|"~     The purpose of this study is to determine the clinical results contributions to surgical~     success,and complications of mixed type of mesh materials as well as prolen mesh materials~     in sling surgery in a 3 year follow-up the first time in literature.~   "
130346|NCT01348321|"~     Different immunologic mechanisms contribute to development of inflammation in acne vulgaris~     and immunologic effect of levamisole has been demonstrated.~      Objective: The aim of this study was to compare azithromycin and levamisole with~     azithromycin alone in the treatment of acne vulgaris.~   "
130347|NCT01348308|"~     The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a~     combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients~     counts may accelerate the kinetics of immune restoration and decrease the risk of disease~     progression and death.~      It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and~     Italy.~   "
130349|NCT01348282|"~     The current project proposes the comparison of two pharmacologic strategies as adjunctive~     treatments for the improvement of HIV-associated neurocognitive disruption, additionally to~     use of HAART. The investigators propose the use of the compound that has shown greatest~     benefits in this context to date, the lithium, versus the use of a well-tolerated and~     promising drug in other pathologies with neurocognitive affectation, such as Alzheimer or~     Parkinson diseases, which is the rivastigmine. In those other diseases, this second compound~     has recently offered a good tolerability, but also benefits on attention, memory and other~     neurocognitive areas. Both study groups, patients on therapy with lithium and patients on~     therapy with rivastigmine, will be compared to a control group, which will not initiate any~     other treatment (therefore only continuing antiretroviral therapy). The investigators are~     aware that this proposal will offer new relevant data for the study of neurocognitive~     improvement in HIV infection, as well will allow a better knowledge of clinical management~     of HIV-infected patients with CNS disease, an aspect that is a common clinical concern~     today.~   "
130350|NCT01348269|"~     The primary aim is to test the reduction of bone marrow edema syndrome after a singular~     intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of~     the edema is defined as biometric data measured by the use of MRT before and six weeks after~     treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the~     treatment of painful bone marrow edema. A statistically significant reduction of the edema~     in the MRT is considered as evidence for efficacy.~   "
130351|NCT01348256|"~     In this randomized multicentric phase II study, patients with colorectal carcinoma with~     resectable hepatic metastasis will be randomized to treatment with dendritic cells or to~     observation, following conventional treatment with surgery and chemotherapy.~   "
130352|NCT01348243|"~     Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis.~      The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at~     least as effective as daily oral therapy and appears more effective than intermittent~     intravenous treatment. Intramuscular clodronic acid in particular has also been associated~     with improvements in back pain. The drug is well tolerated, with no deleterious effects on~     bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal~     adverse effects that may be seen in patients receiving oral bisphosphonates therapy.~      In order to simplify the therapeutic dosing regimen, reducing the number of administrations~     per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new~     formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has~     been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at~     the same concentration as in the 100 mg clodronic acid formulation.~      The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200~     mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy~     post-menopausal volunteers. Two formulations were similar in terms of amount and rate of~     clodronic acid urinary excretion and in terms of safety profile.~   "
130353|NCT01348230|"~     When babies are premature, or born before they are fully developed, they face many different~     medical problems, some of which are quite devastating, such as cerebral palsy, mental~     retardation, blindness, deafness, severe intestinal problems, and developmental delays.~     Unfortunately, in more than half the cases of premature births, there is no procedure or~     test that an obstetrician can employ to predict if a fetus is at risk for premature birth,~     especially when the mother is healthy. This study seeks to determine if certain factors~     found in the urine undergo specific changes that can be used to detect premature births of~     this type before they happen.~   "
130354|NCT01348217|"~     Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks,~     according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of~     patients, whereas no patients survived for 5 years using radiotherapy alone for patients~     with esophageal cancer. Surgery, even when combined with preoperative RCT, also gives~     disappointing results for locally advanced tumors, which casts serious doubts on the~     usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length~     of treatment or the radiotherapy volumes, it has become possible to obtain levels of~     loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional~     relapse according to the dose of radiation and the recommended radiotherapy volumes, we~     aimed to investigate why increasing the dose of radiation has no impact in esophageal~     cancers. Although INT-0123 phase III trial showed no benefit of dose escalation in~     esophageal cancer, some issues remain unclear as most of the patients who died in the~     experimental arm were treated above 50Gy. Moreover, only the tumor was treated up to 64Gy~     while involved nodes were not considered for dose escalation in this trial. In the RTOG~     85-01phase III trial, an elective nodal irradiation from subclavicular fossa up to the~     esophagogastric junction was performed with a 2D technique, delivering 30Gy which could be~     considered as not appropriate.~      In this randomized phase II/III trial, we aim to test an exclusive concomitant~     chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation~     up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique~     combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the~     RTOG) with a risk of microscopic involvement ≥ 20%.~   "
130378|NCT01349088|"~     In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United~     States. The development of new treatment strategies is essential to improve outcome for~     patients with metastatic breast cancer~      There is significant preclinical and clinical evidence indicating that creating new blood~     vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer,~     provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor~     (VEGF) is one of the important molecules regulating new blood vessel formations and~     subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial~     interest for the treatment of advanced diseases.~      This study will further the body of research of motesanib which has been shown in~     preclinical pharmacology and clinical pharmacology studies to be a potent, orally~     bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by~     selectively targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit~     receptors.~   "
130697|NCT01344694|"~     Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty~     liver, a condition carrying a high risk of cardiovascular disease. The independent role of~     epicardial fat deposition in cardiovascular risk remains unclear.~   "
130355|NCT01348204|"~     The purpose of the study is to develop new biomarkers for studies of cystic fibrosis (CF).~     Defects in the gene encoding Cystic Fibrosis Transmembrane Regulator (CFTR) cause CF, an~     autosomal recessive disorder affecting mainly the pulmonary and digestive tract, leading to~     early death largely due to progressive loss of pulmonary function. In vitro experiments show~     that quercetin - a dietary supplement with a well-established safety profile for human use,~     including clinical trials in a variety of disorders encompassing cancer, heart disease, and~     as an anti-inflammatory agent - induces activation of CFTR. The nasal potential difference~     (NPD) test is a measurement of voltage across the nasal membrane and as a fundamental~     biomarker for CFTR activity in vivo. The NPD is a useful, well-established tool in CF~     research to determine both diagnoses as well as to measure the effect of new therapies. In~     vitro experiments show that quercetin induces activation of CFTR additive to that seen with~     current NPD reagents. In addition, it activates rescued mutant CFTR in vitro (∆F508 CFTR the~     most common cause of CF), whereas conventional agonists do not. Preliminary in vivo~     experiments mirrored these results and show that quercetin activates CFTR in human (n=12)~     NPD tests. Importantly, quercetin perfusion was well-tolerated by a validated sinus~     questionnaire and physician assessed nasal examination rating. These studies provide strong~     support for use of quercetin as potentiator of CFTR Cl- channel function by nasal~     administration. By adding quercetin to the sequence of perfusion solutions for NPD, the~     investigators may be better suited to detect ∆F508 CFTR activity of rescued mutant protein~     in the CF patient population.~   "
130356|NCT01348191|"~     It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant~     women are associated with poor obstetric outcome. Also, there is evidence that high TSH is~     related to fetal position at term, including breech which in turn is associated with~     obstetric complications.~      However, the mechanism behind remains to be elucidated.~      The current project is of basic-fundamental nature. It is used to better understand basis~     physiological processes. As in many other studies of similar basic nature, few numbers are~     always included.~      If a TSH receptor will be detected, future randomized controlled trials (RCT) might be~     worthwhile with large numbers of women who will be treated with thyroxine to possibly~     prevent abnormal fetal position during normal pregnancy.~      The aim of the current study is to evaluate whether a TSH receptor can be demonstrated in~     human myometrium. If so, the pathophysiology of high TSH in relation to obstetric outcome~     will become more clear. Furthermore, the aim is to test the myometrium in vitro for its~     relaxation and contractility and for the conductance of electropotentials.~   "
130357|NCT01349361|"~     Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however~     the inconvenience of clinic attendance and discomfort during therapy are significant~     drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of~     BCC.~   "
130358|NCT01349348|"~     To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients~     with cirrhosis ascites who fail to response adequately to treatment with common diuretics.~   "
130359|NCT01349335|"~     To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis~     with ascites and exploring the dosage-effect relations of the drug.~   "
130360|NCT01349322|"~     RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as~     effective as standard per daily radiation therapy in treating breast cancer.~      PURPOSE: This randomized phase III trial studies how well an accelerated course of higher~     per daily radiation therapy with concomitant boost works compared to standard per daily~     radiation therapy with a sequential boost in treating patients with early-stage breast~     cancer that was removed by surgery.~   "
130361|NCT01349309|"~     The purpose of this study is to find out if doing prophylactic or preventative swallowing~     exercises from the start of cancer treatment can improve the ability to swallow when the~     treatment is completed and beyond.~   "
130362|NCT01349296|"~     BIBF1120 and RAD001 in solid tumors~   "
130363|NCT01349283|"~     The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to~     the comparator vaccine both at impeding hepatitis B transmission from mothers positive for~     chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate~     in children of mothers negative for chronic hepatitis B (Stratum 2) one month after~     completion of the immunization schedule.~   "
130364|NCT01349270|"~     Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because~     disease may generate important disability in patients including young adults. Randomized~     trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg)~     can reduce impairment on a short term period but the treatment of a chronic disease doesn't~     agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits~     to demonstrate the superiority of one treatment to the other. Long term adverse effects of~     corticosteroids and IVIg cost are the respective limitation of their use. The investigators~     scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of~     prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6~     months. Patients will be followed during 6 months after the treatment.~   "
130365|NCT01349257|"~     The aim of this clinical study is to compare the lung exposure of the contents of the trial~     drug after administration of the fixed combination between beclomethasone and formoterol~     delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and~     formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device.~     To determine lung exposure, the treatments are administered with charcoal block.~   "
130366|NCT01349244|"~     The purpose of this study is to determine the overall sensitivity and specificity of~     hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to~     hydronephrosis found by CT.~   "
130379|NCT01349075|"~     TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has~     been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere),~     it can be injected into the liver through a blood vessel. This allows a large local dose of~     radiation to be delivered to the tumor with less risk of toxic effects from radiation to~     other parts of the body or to healthy liver tissue.~   "
130560|NCT01346501|"~     The main objective of this study was to determine the ability to maintain response after~     discontinuation of adalimumab treatment and the secondary objective was to determine~     radiographic progression in participants participating in the study, including the~     percentage who displayed minimal progression.~   "
130367|NCT01349231|"~     Roughly one-third of patients with obsessive-compulsive disorder (OCD) do not experience~     significant clinical benefit from first-line interventions such as pharmacotherapy with~     selective serotonin reuptake inhibitors (SSRI) or cognitive behavioral therapy (CBT).~     Furthermore, OCD patients typically experience the full treatment benefits of first-line~     interventions only after a time-lag of two to three months. Inadequate symptom relief and~     delay of symptom relief from first-line treatments are sources of substantial morbidity and~     decreased quality of life in OCD patients. Converging lines of evidence from neuroimaging,~     genetic and pharmacological studies support the importance of glutamate abnormalities in the~     pathogenesis of OCD.~      The investigators are conducting an open, uncontrolled study of ketamine in~     treatment-refractory OCD. Ketamine is a potent antagonist of the N-methyl-D-aspartate (NMDA)~     receptor and has been demonstrated to have rapid anti-depressant effects in patients with~     Major Depressive Disorder. The investigators have additionally provided evidence for rapid~     improvement of comorbid OCD and trichotillomania after ketamine infusion in a depressed~     woman.~      Failure of symptom relief and delay of symptom relief from first-line treatments are a~     source of substantial morbidity and decreased quality of life in OCD patients. Ketamine~     represents the possibility to provide rapid symptom relief to OCD patients and may provide~     the mechanism for future drug development to treat OCD more rapidly and effectively.~   "
130368|NCT01349218|"~     The purpose of this study is to find out whether there is a correlation (link) between the~     level of potassium in blood samples drawn from a vein and those drawn from a heel stick in~     infants scheduled for elective surgery.~   "
130369|NCT01349205|"~     The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10~     mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop~     post extubation adverse upper airway respiratory events compared to placebo.~   "
130370|NCT01349192|"~     Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant~     Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers~     in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses~     showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat~     lung infections in CF it is unclear how the onset of MRSA should be approached. This~     randomized, controlled, interventional study seeks to determine if an early eradication~     protocol is effective for eradication of MRSA and will provide an opportunity to obtain data~     regarding early clinical impact of new isolation of MRSA.~      Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory~     culture on a routine clinic visit.~      Procedures (methods): Randomized, open-label, multi-center study comparing use of an~     eradication protocol to an observational group who receives the current standard of care~     i.e. treatment for MRSA only with pulmonary exacerbations.~   "
130371|NCT01349179|"~     The couple of friction metal-polyethylene is regarded as the couple of reference in spite of~     the osteolysis induced by the wear of the polyethylene which remains the independent factor~     of long-term failure. This is all the more true as the patients are young, thus justifying~     the recourse to alternate couples of friction. The Metasul® couple was introduced on the~     French market under its current form in 1995 (year of its marking EC). The use of a couple~     of friction metal-metal (MM) is justified because it would be likely to improve longevity of~     the total arthroplasties of the active subjects by the reduction in osteolysis related to~     the wear of polyethylene. Various studies highlight evolutions different according to the~     types of fixing acetabular; favourable results of the not cemented cups contrasting with~     unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups of~     cemented Weber type.~   "
130372|NCT01349166|"~     The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular~     morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods~     of prevention and this in early stage of abnormal glucose metabolism.~      This study will assess the beneficial effects of physical activity (acute and chronic~     effects) (the subjects being their own controls) on cardiometabolic and inflammatory~     biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated~     conditions: postprandial response to a standardized meal preceded or not by an exercise~     bout.~      The investigators hypothesized that an acute bout of exercise will decrease the postprandial~     inflammatory response to a standardized meal and that this effect of exercise will be~     increased after 3 months of exercise training.~   "
130373|NCT01349153|"~     The purpose of this study is to determine the feasibility and efficacy of a behavioral~     intervention, delivered through an existing social networking website (Facebook), on~     physical activity (moderate-intensity minutes per week) among young adult cancer survivors~     compared to a self-help education condition. For this research study, investigators will~     conduct a 12-week randomized trial. After a baseline survey, weekly messages, a pedometer,~     goal-setting tool, physical activity log and discussion prompts will be delivered to the~     intervention group. Comparison group participants will receive links to websites with~     self-help education materials. After 12 weeks, a follow-up survey will be given to both~     groups. Changes in physical activity, quality of life and psychosocial factors will be~     examined. The investigators hypothesize that those receiving the intervention will have~     improved physical activity behaviors at 12-week follow-up relative to those in the~     comparison group.~   "
130374|NCT01349140|"~     EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic~     (numbing medicine) that is designed to be longer acting than the currently-available local~     anesthetics. The purpose of this study is to determine the effect on thigh muscle strength~     and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to~     the thigh.~   "
130375|NCT01349127|"~     This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg~     cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to~     assess vitamin D requirements in lactating women and to ascertain whether vitamin D~     supplementation at levels sufficient to achieve defined thresholds of maternal serum~     25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will~     also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and~     describe the relationship between them. Information on maternal iPTH levels, anthropometry,~     diet and sun exposure will also be reported.~   "
130376|NCT01349114|"~     The study will evaluate the effects of the direct renin inhibitor, aliskiren, on~     flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic~     patients with pre-hypertension or Stage 1 hypertension.~   "
130380|NCT01349062|"~     This research work is important for the cure/control of HIV infection. The study is intended~     to confirm the efficacy of Kallunk Oxide (Immunotherapy) molecules in the Treatment of HIV~     infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order~     to boost the body's natural immune ability against infection. The basic study is directly~     inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T~     cells and the CD45+. cells.~      The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and~     lifestyle can be more easily studied.~   "
130381|NCT01349049|"~     The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels~     (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with~     relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200~     mg/day may be considered based on safety and efficacy observations.~   "
130382|NCT01349036|"~     The objective of this study is to evaluate the response of subjects with recurrent~     glioblastoma to continuous therapy of PLX3397.~   "
130383|NCT01349023|"~     Pre-portioned entrées are commonly consumed to help control portion size and limit energy~     intake. Few studies, however, have investigated the influence of the characteristics of~     pre-portioned entrées on energy intake. This study investigates how the characteristics of~     solid pre-portioned entrées, specifically, variations in their energy content and energy~     density influence energy intake over a day. The investigators hypothesize that reducing the~     energy content and energy density of compulsory entrées will act independently and add~     together to reduce daily energy intake.~   "
130384|NCT01349010|"~     The purpose of this study is to evaluate the efficacy and safety of imported Probucol in~     hyperlipidemia patients.~   "
130385|NCT01348997|"~     This study will develop and examine the effectiveness of an intervention that utilizes~     technology to improve cancer survivors' access to mental health care and increase their~     ability to manage the stressors involved in cancer survivorship. The intervention, referred~     to as Project Onward, uses an interactive website and an online social network. The purpose~     of this study is to pilot a novel intervention that can reduce costs, examine methods to~     improve adherence to internet based treatment and overcome numerous barriers to treatment~     for mental health concerns.~   "
130386|NCT01348984|"~     The purpose of this study is to determine whether transdermal fentanyl patch~   "
130387|NCT01348971|"~     The purpose of this study is to determine whether oral sodium nitrate administration prior~     to coronary artery bypass surgery can reduce perioperative levels of troponin T. In~     addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be~     monitored.~   "
130388|NCT01348958|"~     This study is to compare scans of the knee performed using new software designed~     specifically to look at the knee joint with those performed using approved software designed~     for scans of the hip.~   "
130389|NCT01348945|"~     Anterior cruciate ligament (ACL) is known to serve a number of functions in the knee joint.~     Besides providing mechanical stability, it also contributes to proprioceptive function.~     Numerous studies reported ACL is rich in mechanoreceptors contribute in proprioceptive~     function. ACL augmentation, or selective ACL bundle (AM, anteromedial or PL, posterolateral)~     reconstruction, a relatively new technique for partial torn ACL, preserves and augments the~     ACL remnant aiming at maintaining or facilitating proprioception, is now gaining its~     popularity. Preserving ACL stump is also reported to have merits in providing better~     mechanical protection and promoting revascularization to the newly reconstructed graft.~      In local setting, stump preserving ACL surgery is the usual practice in handling partial ACL~     tear. With the background of the surgery's potential benefits in restoration of knee~     function, a single-blinded, comparative study on the difference in proprioception, postural~     stability and clinical outcome between stump preserving ACL surgery and reconstruction is~     conducted.~   "
130390|NCT01348932|"~     The objective of this study was to investigate the relationship between single nucleotide~     polymorphism of chitinase 3-like 1 and human asthma.~   "
130391|NCT01348919|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     CEP-18770 in combination with lenalidomide and dexamethasone in patients with relapsed or~     refractory multiple myeloma.~   "
130392|NCT01348906|"~     This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass~     (CPB) on inflammatory response, oxidative stress and myocardial reperfusion injury in adult~     patients undergoing valve replacement. The investigators hypothesized that nuclear factor~     kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.~   "
130393|NCT01348893|"~     The purpose of this preliminary study is to evaluate the effects of a yoga-based program on~     high school students' psychological health. Results will be used to generate specific~     hypotheses of how yoga may improve adolescent mental health.~   "
130394|NCT01348880|"~     The study will be conducted as a multi-center, randomized, double-blinded, placebo~     controlled, crossover design. The investigational drug (vardenafil ODT (Orally~     Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg~     vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single~     administration during the opposing period. The random code will determine the order of~     active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate~     profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods~     1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be~     background treatment for hypertension, taken daily by each subject. All subjects must be~     stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special~     conditions for this study include the requirement that all subjects will be male, are~     between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED),~     as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary~     analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and~     69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of~     the study will be approximately one year from first subject treated to last subject treated,~     including replacement of any subjects who fail to complete both periods of crossover dosing.~   "
130395|NCT01348867|"~     The investigators hypothesize a diabetes nurse consultant led team with particular emphasis~     on compliance and attainment of treatment targets in Type 2 diabetic patients will achieve~     metabolic control, improve clinical outcomes and levels of self efficacy compared to usual~     clinic-based care.~   "
130397|NCT01348841|"~     Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in~     the community for most of these is coordinated by the local Community Care Access Centre~     (CCAC). One or more health professionals might deliver treatment, individually or as part of~     a wound care team, with different members having different kinds of training~     (interdisciplinary team), which may or may not include wound care. Community treatment by~     interdisciplinary teams has been shown to be more effective and cost-effective for some~     long-standing health problems, but further scientific evidence is needed to determine if~     this is also true for chronic wounds.~      This study compares the usual way chronic wounds are being managed in the community with a~     so-called intermediate care approach. In this study, intermediate care will involve health~     service providers following certain agreed-upon steps (evidence-based best practice) from~     first contact with the client through assessment, treatment, and on to referral to a~     hospital specialty wound care team, if needed.~   "
130398|NCT01348828|"~     The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated~     Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.~   "
130399|NCT01348802|"~     Pain is a problem for many Canadians. Unfortunately, many doctors, nurses, therapists, and~     psychologists have trouble keeping up to date and applying the latest research that might~     help patients suffering with pain. This study will determine whether sending alerts about~     new pain research directly to these health professionals, and providing them with access to~     accumulated alerts, will help. The study will compare knowledge and decisions made by health~     professionals about managing pain problems. The investigators will compare physicians,~     nurses, rehab therapists and psychologists at the beginning of the study and after having~     access to different ways to find out about new pain research. One group will receive alerts~     about new pain studies that have been found to be high quality and relevant to patient care,~     and will be able to search the alerts database. The other group will be able to find the~     same studies,but must go to the database of research studies to locate them. The~     investigators will include 670 doctors, nurses, rehab therapists, and psychologists in this~     study. A process like tossing a coin will determine which way they are able to get pain~     research information. The investigators will monitor how much information they access and~     how they apply it to managing pain problems. The investigators expect that reminding health~     care providers about new research findings directly will help them, since difficulty finding~     studies and lack of time prevent them from using the latest research. The investigators~     expect that reminders about the latest research will help them make better decisions about~     caring for patients' pain.~   "
130400|NCT01348789|"~     To measure the safety of hair removal device when used frequently.~   "
130401|NCT01348776|"~     The purpose of this study is to determine efficiency of Hair2Go device for short-term and~     long-term removal of unwanted hair adjunctive to shaving using a before-after study design.~   "
130402|NCT01348763|"~     This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects~     currently attending for HIV care at St. Mary's Hospital, London will be eligible.~      The study will describe the steady state pharmacokinetic parameters and short term safety of~     maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without~     tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.~      Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be~     receiving antiretroviral therapy comprising:~        -  tenofovir/emtricitabine 245/200 mg daily plus~        -  darunavir/ritonavir 800/100 mg daily~      On day 1, subjects will modify their current antiretroviral therapy to the following:~        -  tenofovir/emtricitabine 245/200 mg daily plus~        -  darunavir/ritonavir 800/100 mg daily plus~        -  maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic~          visit.~      On day 11, subjects will modify their current antiretroviral therapy to the following:~        -  darunavir/ritonavir 800/100 mg daily plus~        -  maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20~          subjects will undergo an intensive pharmacokinetic visit. Following completion of this~          study phase, subjects will recommence their usual antiretroviral treatment regimen and~          attend for a study follow up visit.~   "
130403|NCT01348750|"~     This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a~     complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces~     Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in~     returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims~     will evaluate the effect of HT and GI on measures of depression, hostility, and general~     health status in this population.~   "
130404|NCT01348737|"~     The purpose of the study is to assess the safety, tolerability and blood concentration of~     AZD3839 following oral administration of single doses in healthy men and women of~     non-childbearing potential~   "
130405|NCT01348724|"~     Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a~     Single-Dose Oral Administration.~   "
130406|NCT01348711|"~     To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their~     combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at~     12-14 weeks of gestation~   "
130441|NCT01348048|"~     Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in~     patients with a life threatening disease such as advanced cancer. Many patients with~     advanced cancer are not in contact with SPC. Previous studies have shown that among advanced~     cancer patients not referred to SPC there is a significant prevalence of symptoms, problems~     and needs. The aims of the present study are to investigate whether patients with metastatic~     cancer, who report palliative needs in a screening, will benefit from being referred to SPC~     and to investigate the economical consequences of such a referral.~   "
130442|NCT01348035|"~     Increased water intake slows autosomal dominant polycystic kidney disease (ADPKD)~     progression in animal models, but clinical implication is unknown. Encouraged water intake~     in patients with ADPKD for one year resulted in accelerated kidney enlargement and~     functional deterioration. Increased urine sodium and/or unknown factors concurrent with~     increased urine volume might stimulate disease progression more strongly than decrease in~     plasma vasopressin ameliorated it.~   "
130572|NCT01346345|"~     Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary~     laterals and mandibular incisors~   "
130407|NCT01348698|"~     Background:~      - Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are~     no tests that can accurately tell which adrenal tumors are cancerous and which are not. The~     only way to tell is to remove the tumor with surgery and then examine it. Researchers have~     been using new methods to study samples of adrenal tissue. These methods may help identify~     whether the cells are or may become cancerous without an operation. This information will~     help doctors determine which tumors will need to be removed.~      Objectives:~      - To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods~     that may help identify cancerous or precancerous cells.~      Eligibility:~      - Individuals at least 18 years of age who have an adrenal tumor that may or may not be~     cancerous.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood and~          urine tests, and imaging studies.~        -  Participants will be examined to determine whether they have a specific type of adrenal~          tumor~      (pheochromocytoma).~        -  Participants whose tumor does not secrete hormones will have a tumor biopsy to collect~          tissue for study.~        -  Participants who have a large tumor or one that secretes hormones will have standard~          surgery to remove the tumor. Tissue will be collected for study.~        -  Researchers will examine the collected tissue. They will try to determine whether the~          cells are cancerous or may become cancerous.~        -  Participants will be asked to return to the National Institutes of Health Clinical~          Center every year for about 5 years. During these visits they will have imaging~          studies, lab tests, and a physical examination....~   "
130408|NCT01348685|"~     To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its~     component mixtures and whey protein on subjective appetite and food intake in young men.~   "
130409|NCT01348672|"~     Canadians fear loss of vision more than any other disability. Vision loss has an enormous~     impact on quality-of-life and is extremely costly from a societal and economic perspective.~     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting~     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by~     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial~     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that~     vision loss is normal with aging but 75% of vision loss is estimated to be preventable.~     The major causes of severe vision loss are age-related macular degeneration (ARMD),~     glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR).~     Canada is headed for an epidemic of age-related eye disease and, unless something is done to~     prepare for this, severe vision loss will have significant consequences in terms of societal~     and economic costs. Through this proposed Research Program, and in conjunction with the~     investigators international academic and private sector partners, the investigators will~     build and develop unique quantitative imaging technologies to permit non-invasive assessment~     of visual changes, structural changes in the thickness of the retina at the back of the eye~     and also changes in the amount of blood flowing through the blood vessels that feed the~     retina with oxygen. This research will add to the investigators basic knowledge in~     predicting the development of sight-threatening change in patients with the three diseases,~     and facilitate earlier detection of the problem to help us discover earlier treatments for~     people with these conditions. The reliability of each imaging technology will be assessed by~     determining its ability to differentiate between diseased and healthy eyes. Cross-sectional~     analyses at yearly intervals, as well as change over time analyses, will be undertaken.~   "
130410|NCT01348659|"~     The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch~     solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass~     grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir~     of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight~     and extracellular water from baseline to the first postoperative morning.~   "
130411|NCT01348646|"~     The purpose of this study was to see whether a brief intervention given in adolescence has~     an effect on smoking in adulthood. The investigators also wanted to clarify the significance~     of some known psychosocial risk factors of smoking in adulthood.~   "
130412|NCT01348633|"~     Canadians fear loss of vision more than any other disability. Vision loss has an enormous~     impact on quality-of-life and is extremely costly from a societal and economic perspective.~     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting~     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by~     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial~     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that~     vision loss is normal with aging but 75% of vision loss is estimated to be preventable.~     The major causes of severe vision loss are age-related macular degeneration (ARMD),~     glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR).~     Canada is headed for an epidemic of age-related eye disease and, unless something is done to~     prepare for this, severe vision loss will have significant consequences in terms of societal~     and economic costs. Through this proposed Research Program, and in conjunction with our~     international academic and private sector partners, we will build and develop unique~     quantitative imaging technologies to permit non-invasive assessment of visual changes,~     structural changes in the thickness of the retina at the back of the eye and also changes in~     the amount of blood flowing through the blood vessels that feed the retina with oxygen. This~     research will add to our basic knowledge in predicting the development of sight-threatening~     change in patients with the three diseases, and facilitate earlier detection of the problem~     to help us discover earlier treatments for people with these conditions. The reliability of~     each imaging technology will be assessed by determining its ability to differentiate between~     diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change~     over time analyses, will be undertaken.~   "
130413|NCT01348620|"~     This is a single-institution, prospective, randomized controlled trial. Subjects determined~     to need a cholecystectomy will be consented for surgery and study participation prior to~     enrollment in this study. Patients will then be randomized to receive either a single port~     laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.~   "
130414|NCT01348607|"~     RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and~     improve the quality of life of patients with excessive daytime sleepiness after cancer~     therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more~     effective than a placebo in reducing daytime sleepiness in these patients.~      PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or~     modafinil to see how well they work compared with a placebo in treating young patients with~     excessive daytime sleepiness after cancer therapy.~   "
130443|NCT01348022|"~     This study is a multicenter, open label, prospective, single arm trial~      Single arm group; following angiography, eligible patients with unprotected LMCA stenosis~     >50% by visual estimation, which is equally treatable by the both treatment strategy (EES~     stenting or CABG), will be treated with EES~   "
130444|NCT01348009|"~     Cisplatin, an intravenously administered platinum agent, in combination with an~     intravenously administered taxane and capecitabine has been shown to improve time to disease~     progression and overall survival in previously untreated patients with gastric cancer.~      This study is being performed to evaluate an orally administered taxane (tesetaxel) in~     combination with cisplatin and capecitabine in previously untreated patients with gastric~     cancer.~   "
130415|NCT01348594|"~     Infertility is a common and psychologically devastating problem for 20% of Canadian couples.~     Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left~     without an explanation for their inability to have a baby. Pathological uterine receptivity~     and embryo implantation are hypothesized mechanisms underlying sub-fertility in these~     couples. Embryo implantation requires a complicated sequence of events involving the~     differentiation of endometrial cells to attain uterine receptivity and the synchronized~     interaction between maternal and embryonic tissues. Vitamin D has been hypothesized to play~     a role in this poorly understood process. Vitamin D is a known regulator of signal~     transduction pathways involved in embryo implantation and its receptors are involved in~     calcium-regulation in various reproductive tissues including, the ovary, uterus, and~     placenta. In Canada, the prevalence of Vitamin D insufficiency is approximately 34-50%. The~     goal of the proposed study is to determine the prevalence of vitamin D insufficiency in an~     infertile population and whether this prevalence is higher than in average Canadian~     reproductive age women. More importantly, we will investigate whether vitamin D~     insufficiency in our infertile population translates to impaired implantation and reduced~     clinical pregnancy rates. Insight into vitamin D's role in reproduction is essential not~     only to provide scientific understanding of the mechanism underlying embryo implantation,~     but also because vitamin D supplementation could provide an easy and safe means of treating~     infertility.~   "
130416|NCT01348581|"~     The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of~     fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.~      The wound dressing is indicated for the management of difficult to heal and chronic wounds.~     The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary~     dressing is put on top. Further dressing of the wound depends on the etiology.~      The indications for use are:~        -  partial and full-thickness wounds~        -  pressure ulcers~        -  venous ulcers~        -  diabetic ulcers~        -  chronic vascular ulcers~        -  tunneled/undermined wounds~        -  trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)~   "
130417|NCT01348568|"~     Healthy individuals with type 2 diabetes will receive intensive counseling on food selection~     to improve glucose control using either high cereal fiber dietary strategies or low glycemic~     index foods especially canola oil containing bread. The treatments will last 3 months with~     bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or~     both diets, then use of high fiber, and/or low glycemic index foods with canola oil, may~     provide another potential way to improve glucose control and lower cholesterol levels in~     non-insulin dependent diabetes.~   "
130418|NCT01348555|"~     Pulmonary administered anticholinergic agents have shown their importance in the chronic~     obstructive pulmonary disease (COPD) management to reduce morbidity, disability and~     mortality. To date, the recommended treatment of moderate to severe COPD patients consist in~     the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a~     medical need in new product that could exhibit both anti-inflammatory and strong~     bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.~      Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound~     and could bring new option in the treatment of this life-threatening disease.~   "
130419|NCT01348542|"~     The purpose of this study is to evaluate the effect of a 3 month medication trial of~     Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic~     insomnia.~   "
130420|NCT01348529|"~     The main aim of this study is to test whether cognitive behavior therapy could be effective~     in treating obsessive compulsive disorder. Here, the investigators test the in group effects~     of a 15 week long treatment delivered via the Internet for residents in Stockholm County.~   "
130421|NCT01348516|"~     The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after~     single/multiple dosing.~   "
130422|NCT01348503|"~     The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and~     Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with~     surgery.~   "
130423|NCT01348490|"~     To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume,~     symptoms and potential side effects in patients with PMF, PPV-MF and PET-MF who have~     platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose~     optimization from the starting ruxolitinib level of 5 mg bid will be associated with~     reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.~   "
130424|NCT01348477|"~     The investigators describe a new surgical technique for inguinal hernia open repair, which~     will be compared with the Lichtenstein technique. The investigators seek to find the~     difference between the two techniques in postoperative pain.~   "
130425|NCT01348464|"~     The aim of this study is to compare patients who undergone single-port access laparoscopic~     appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA)~     in a prospective randomized trial~   "
130426|NCT01348451|"~     This is a first-in-human trial of spinal derived stem cells transplanted into the spinal~     cord of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see~     if the cells and the procedure to transplant them are safe.~   "
130427|NCT01348438|"~     The purpose of the study is to evaluate the safety and clinical performance of the Engager~     Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis~     who are at high risk for surgical valve replacement.~   "
130428|NCT01348425|"~     This randomized, post-market clinical study is intended to evaluate the delivery and~     deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80~     mm) for treatment of lesions of the above-the-knee femoropopliteal artery.~   "
130445|NCT01347996|"~     Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia~     Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission.~     This is an international, multicenter, open-label study to evaluate the effects of remission~     maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune~     system cells (T and NK cells) and prospectively defined markers of immune response that are~     known to reflect T and NK cell ability to combat AML.~   "
130446|NCT01347983|"~     24 week open-labeled extension study to continue monitoring the same group of patients in~     the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and~     safety of tocilizumab.~   "
130429|NCT01348412|"~     Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan~     alone or in association with fluoropyrimidines, oxaliplatin in association with~     fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen~     the national reference frame on the basis of phase II study proposes an association of~     fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with~     progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is~     logical in the case of isolated hepatic metastases nonaccessible to curative resection: 1)~     hepatic metastases are vascularized by hepatic arterial system in contrast to nontumoral~     hepatic parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the~     liver during the first passage, a high intra-tumoral concentration and a low systemic~     concentration. So oxaliplatin is a drug of choice for arterial treatment but combination~     with fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is~     not available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase,~     does not require a prolonged perfusion and could be a good substitute.In a previous pilot~     study we demonstrated the feasibility, safety and efficacy of combination of raltitrexed and~     oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to~     evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin~     association versus standard chemotherapy for patients with metastases of colorectal origin~     restricted to the liver after failure of conventional chemotherapy.~   "
130430|NCT01348399|"~     The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in~     the real world daily practice as compared with other drug eluting stents (DESs)~   "
130431|NCT01348178|"~     This is a retrospective study assessing pre- and postoperative radiographic indices of hip~     dysplasia in order to identify factors predicting failure following Periacetabular Osteotomy~     (PAO).~   "
130432|NCT01348165|"~     Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in~     Healthy Male Volunteers~   "
130433|NCT01348152|"~     The primary objective of this study is to evaluate the improvement in the severity of~     constipation (from Baseline to Day 28), determined by the constipation severity instrument~     (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100~     administered for 28 consecutive days in adult subjects with functional constipation.~   "
130434|NCT01348139|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single~     doses of three different dry powder inhalation formulations of AZD3199 administered via~     Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and~     compared to placebo in patients with persistent asthma.~   "
130435|NCT01348126|"~     The purpose of this study is to determine whether combining ganetespib (STA-9090) with~     docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced~     non-small cell lung cancer.~   "
130436|NCT01348113|"~     Excessive alcohol consumption is a worldwide major public health problem. Brief~     interventions have shown to be an efficient treatment modality for problem drinkers, but~     have never been tested in scheduled surgery.~      Patients will be recruited in various surgery units in 7 hospital in France. All patients~     attending a scheduled surgery will be screened during the visit with the anaesthesist by the~     Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between~     7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study~     and randomized between a brief intervention by a trained nurse during the post-surgery~     hospitalisation and no intervention. Twelve months after the surgery, a research technician~     will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last~     month.~   "
130437|NCT01348100|"~     This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation~     of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in~     support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the~     safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and~     safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be~     selected for assessment in Phase C. Phase C of this study is designed to define the~     dose-exposure relationship of the selected form and to provide information that will permit~     a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal~     dose selection for later studies.~   "
130438|NCT01348087|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data~     for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212~     (NCT01253629).study and patients who have participated in the previous proof-of-concept~     study CAFQ056A2204 (NCT00718341).~   "
130439|NCT01348074|"~     It is not known how to best restart warfarin after temporary withdrawal. Participants will~     be randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose,~     group 2 will restart warfarin at double their maintenance dose for two days followed by~     their usual maintenance dose. The main outcome parameter will be the number of patients who~     are back in therapeutic INR (international normalized ratio) range 4, and 9 days after~     restarting anticoagulation with warfarin. Thromboembolic and/or bleeding events will be~     recorded as additional parameters. These data will be collected by a standardized telephone~     interview at 1 month. In addition, the investigators will evaluate a possible prothrombotic~     state by measuring the potential of thrombin generation and D-dimers in the subset of~     patients visiting HHS-General Hospital for their INR tests.~   "
130440|NCT01348061|"~     This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF)~     biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP)~     compared to healthy controls using a heavy water (2H2O) labeling method. This study is~     exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo~     proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls,~     due to deficits in fast axonal transport.~   "
130447|NCT01347970|"~     This randomized phase II trial studies the side effects and how well low-dose carvedilol~     works in preventing congestive heart failure (CHF) in younger cancer survivors exposed to~     high dose anthracyclines for management of childhood cancer. Carvedilol may help lower the~     risk of cardiovascular complications~   "
130573|NCT01346332|"~     The study will recruit healthy volunteers to undergo the iontophoresis procedure using the~     Acclarent Iontophoresis System with Headset.~   "
130448|NCT01347957|"~     Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle~     formation and growth in both rat and mouse models. The NO gel induced major physiological,~     developmental, and structural changes in the skin of mammals to increase the number of hair~     follicles, follicle stem cell development and regeneration as well as hair shaft elongation,~     and accelerated hair growth rate. Based on our animal model findings, the investigators~     hypothesize that the nitric oxide releasing gel could be used as a medical treatment for~     hair growth in humans. The objective of this trial is to evaluate the safety and efficacy of~     this NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment~     schedule.~   "
130449|NCT01347944|"~     The purpose of this study is to collect clinical and laboratory data for patients affected~     by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who~     were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for~     these patients since October 2008 based on a local disposition of the Italian Drug Agency~     (AIFA) issued according to a National law named 648/96.~   "
130450|NCT01347931|"~     The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic~     respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system~     will accomplish this by providing oxygen under pressure and augmenting the subject's~     spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted~     ventilation, and a comfortable low-profile device, will result in a mean improvement in~     perceived well-being and ability to perform ADLs, as measured by patient-reported outcome~     (PRO) instruments.~   "
130451|NCT01347918|"~     The aim of this project is to demonstrate and validate the ionizing radiation free and non~     invasive assessment of small intestinal anatomy, content and function in healthy and disease~     by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging~     (MRI) framework. Meal induced and pathology related alterations in small intestinal motor~     activity, gas distribution and anatomy of healthy volunteers and patients with irritable~     bowel syndrome (IBS) will be analyzed with this non invasive MRI approach.~      The multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system~     with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F~     surface coil, fluorine labelled impermeable and biocompatible capsules for oral~     administration (19F capsule) and a 19F projection imaging sequence allowing for the~     non-invasive detection of the gastrointestinal positions of single and multiple ingested~     capsules in real time. Dedicated post-processing algorithms are applied to extract~     parameters of intestinal motor activity from the detected intraluminal capsule movements.~      The proposed unique imaging modality allows for the concurrent, non invasive and repeated~     analysis of important physiologic parameters of intestinal function together with detailed~     anatomical information and thus presents an ideal tool for the evaluation of the analyzed~     parameters as potential biomarkers in IBS.~        -  Trial with medical device~   "
130452|NCT01347905|"~     The objective of this study is to investigate if weight loss, in particular due to adipose~     tissue loss, in obese patients will reverse the obesity-related reduction of iron~     absorption, and if this is due to a decrease in hepcidin concentrations. Additionally, the~     investigators will investigate changes in iron incorporation into erythrocytes due to a~     reduction of iron sequestration by the adipose tissue and reticuloendothelial system. The~     investigators expect that by decreasing adiposity, circulating hepcidin levels will~     decrease, iron absorption and incorporation into erythrocytes will increase and as a result~     iron status will be improved.~   "
130453|NCT01347892|"~     The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo~     NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical~     setting. Outcomes to be assessed include pain, function, activity levels and healthcare~     resource use.~   "
130454|NCT01347879|"~     This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy~     (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that~     Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is~     different compared to vehicle PDT at week 12.~   "
130455|NCT01347866|"~     After the fourth protocol amendment two study arms are evaluated in this clinical protocol:~     PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and~     PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and~     pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum~     tolerated doses are identified, further assessment of these combinations will be done in~     patients with previously treated metastatic colorectal or pancreatic cancer for the~     PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non~     small cell lung cancer for the combination of PF-05212384 plus PD-0325901.~   "
130456|NCT01347853|"~     This was a randomized, double-blind, placebo-controlled study in subjects who underwent~     major surgery. Each subject's study participation consisted of a screening visit and a~     treatment period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned~     to receive intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI)~     rating equaled at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study~     drug every 8 hours for 48 hours and then 3 times daily for up to 5 calendar days in total;~     the frequency of dosing could be reduced after 48 hours. Starting at the time of the first~     dose of study drug and continuing for the first 48 hours after surgery, the subjects had~     access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). After~     PCA was no longer required, backup pain relief was provided by another standard nonsteroidal~     anti-inflammatory drug (non-NSAID) analgesic regimen. If the subjects were discharged before~     postoperative Day 4, they could self-medicate at home through postoperative Day 4. A safety~     follow-up evaluation was conducted by telephone approximately 14 days after the end of~     dosing in a subset of subjects (n = 60).~      The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of~     ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety~     and tolerability of this dosing regimen.~   "
130457|NCT01347840|"~     The objective of this study is to determine whether the metabolic, endocrine and energetic~     response to short term caloric restriction are factors in weight loss in subjects having~     gastric bypass (GB) surgery.~   "
130574|NCT01346319|"~     Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of~     testosterone in hypogonadal males.~   "
130458|NCT01347827|"~     The goal of this study is to determine if off-pump CABG surgery is associated with better~     cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators~     would like to compare the results of two different monitors of brain tissue oxygenation with~     each other, and assess the correlation between brain tissue oxygenation and oxygenation~     measurements in renal and muscular tissue, as well as with conventional hemodynamic and~     metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the~     investigators aim to determine if duration and extent of cerebral oxygen desaturation~     predict outcome variables such as postoperative cognitive performance.~   "
130459|NCT01347814|"~     The purpose of this study is to determine whether domperidone was sufficient to accelerate~     gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult~     population.~   "
130460|NCT01347801|"~     The purpose of this study is to determine the role of inflammation and the insulin~     regulating hormone GLP-1 during critical illness.~   "
130461|NCT01347788|"~     Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib~     works by blocking the angiogenesis, or the growth of new blood vessels, to the tumor. This~     is similar to how several other cancer drugs work but in addition Cabozantinib also blocks~     other pathways that may be responsible for allowing cancer cells to become resistant to~     these other anti-angiogenic treatments. So far cabozantinib has been investigated in~     treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses~     of cabozantinib with the goal to find the most effective, safe, and tolerable dose without~     undesirable side effects.~   "
130462|NCT01347775|"~     This study will investigate whether inspiratory muscle training in patients with end stage~     renal failure can improve strength and function.~   "
130463|NCT01347762|"~     Cannabis use disorders are an important public health problem in the United States, but~     there are no effective medications available to treat these disorders. The investigators~     intend to test a medication with interesting properties, nabilone, as a treatment for~     cannabis dependence and to study the relationship of this treatment with the brain using~     functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and~     the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while~     allowing treatment-seeking patients to benefit from behavioral treatments when they are~     trying to stop using cannabis. The investigators propose to assess the relationship of~     nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent~     patients. The investigators also aim to determine the effects of nabilone on performance on~     neuropsychological tests and to assess the correlation of neuropsychological performance to~     brain changes using functional MRI brain scans. The investigators hypothesize that patients~     receiving nabilone will reduce their use of cannabis more than patients receiving placebo~     during this 10-week treatment trial.~   "
130464|NCT01347749|"~     This project will study whether a new therapy that includes the practice of forms of~     meditation is helpful for combat veterans returning from deployments in Iraq or Afghanistan~     suffering with posttraumatic stress disorder (PTSD). Mindfulness meditation cultivates~     present-focused, non-judgmental attention to ones body, emotions, and thoughts, and is~     proposed to lead to a greater sense of well-being and acceptance and better tolerance of~     painful and distressing emotions. Compassion and loving-kindness meditations help~     stabilize positive emotions like love and compassion, and may also be helpful for chronic~     pain, and possibly depression and PTSD.~      This study will compare a 16 week psychotherapy group for PTSD involving Mindfulness and~     Self-compassion meditation, with a more standard form of group psychotherapy known as~     Present-centered group therapy. Both therapies will be conducted at the VA Ann Arbor PTSD~     clinic by VA psychotherapists. (The study is also approved by the IRB of the VA Ann Arbor).~     Combat veterans will be randomly assigned to either the Meditation or the standard group~     psychotherapy. All patients will also receive fMRI brain scans before and after the therapy,~     as well as assessment interviews before, at 8 weeks, and immediately post-therapy, and at 3~     mo and 6 mo follow-ups. Saliva cortisol and measures of attention will also be obtained at~     each assessment.~   "
130465|NCT01347736|"~     This pilot clinical trial studies how well scrambler therapy works treating chronic pain in~     patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve~     pain from a rash caused by varicella zoster virus infection~   "
130466|NCT01347723|"~     This pilot clinical trial studies scrambler therapy in treating pain and peripheral~     neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help~     relieve pain from peripheral neuropathy caused by chemotherapy~   "
130467|NCT01347710|"~     The primary objective of the study is to assess the diagnostic efficacy (specificity and~     sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to~     single photon emission computed tomography (SPECT) MPI in the detection of significant~     coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a~     documented history of Myocardial Infarction (MI).~   "
130468|NCT01347697|"~     The trial compares two different techniques for reconstruction of the lesser pelvic floor~     after an extended abdominoperineal excision for locally advanced rectal cancer. The~     alternative reconstruction techniques in the trial are:~        -  a technique using a gluteus maximus myocutaneous flap or~        -  a technique using an acellular porcine collagen implant~      The primary endpoint will be physical performance six months from operation and our~     hypothesis is that the technique using an acellular porcine implant will cause less impaired~     physical performance compared to the technique using a myocutaneous flap.~      The study is interventional, randomized and by definition a comparative effectiveness~     research project.~   "
130469|NCT01347684|"~     The primary aim of the pilot data proposal is to compare usual care (medications) versus~     multi-disciplinary treatment in temporomandibular disorder (TMD) patients.~   "
130470|NCT01347671|"~     The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients~     with painful diabetic neuropathy.~   "
130471|NCT01347658|"~     The purpose of this clinical trial is to characterize drug interactions between one~     medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.~   "
130472|NCT01347645|"~     The purpose of the Phase Ib portion is to find out the highest dose of study drug that can~     safely be given when tested in a small group of subjects.~      The purpose of the Phase II portion is to find out how safe the study drug is when taken at~     the highest dose in a larger group of subjects.~   "
130473|NCT01347632|"~     This is a research study to determine whether bacterial vaginosis (BV) changes the~     cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk~     for getting HIV (Human Immunodeficiency Virus). Vaginal and cervical tissue biopsies from~     women with BV will be obtained and infected OUTSIDE the body (ex vivo) with HIV.~      BV is a vaginal infection that develops when there is an imbalance in the normal bacteria~     found in a woman's vagina. It is the most common cause of vaginal discharge among women of~     child-bearing age. BV infections potentially harm the safety of the tissue surrounding the~     cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of~     acquiring HIV from an infected partner might increase significantly. Studies have shown that~     HIV is more common in women with BV than in women with normal vaginal bacteria.~      Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria~     and provide a temporary relief from the symptoms caused by the infection. Women~     participating in this study will use the generic antibiotic metronidazole, also known as~     Flagyl. The Center for Disease Control and Prevention (CDC) recommends Flagyl for the~     treatment of BV.~      The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3~     different time periods:~        1. During a BV infection~        2. Approximately 1 week after completing a 7-day course of metronidazole therapy~        3. Approximately 1 month after completing the 7-day course of metronidazole therapy~      You will not come in contact with HIV during this study - only your samples (after we have~     removed them from your vagina/cervix) come in contact with HIV.~   "
130474|NCT01347619|"~     The investigators propose to evaluate the effectiveness of 3 different methods to promote~     the dissemination and adoption of evidenced-based review guides into the nursing home~     setting. Specifically, the investigators will adapt Comparative Effectiveness Research (CER)~     Review products developed by the Agency for Healthcare Research and Quality (AHRQ),~     specifically related to off-label use of atypical antipsychotic drugs, to improve their~     penetration into practice in the nursing home (NH) setting.~      The investigators propose the following specific aims:~      AIM 1: NEEDS ASSESSMENT To conduct a needs assessment for the NH setting relevant to the~     AHRQ Comparative Effectiveness Research Summary Guide (CERSG) entitled Off-Label Use of~     Atypical Antipsychotic Drugs. The assessment will identify: (a) interest in and barriers to~     the use of the AHRQ atypical antipsychotic CERSG in the NH setting; (b) the key audiences~     and stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches~     to integrating comparative effectiveness research products into the NH setting.~      AIM 2: PRODUCTION OF THE TOOLKIT Guided by the needs assessment, the investigators will~     produce a toolkit containing tailored CERSG-based products targeting key audiences and~     stakeholders in the NH setting. The target audience(s) of the final CERSG-based products~     will be identified in Aim 1, and will potentially include: (a) facility leadership [NH~     administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant~     pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified~     nurse assistants].~      AIM 3: EVALUATING THE EFFECTIVENESS OF THE TOOLKIT To evaluate the effectiveness of the~     toolkit and three dissemination strategies using a matched, cluster randomized trial. NHs in~     the first arm will receive the toolkit only and web access to the materials; NHs in the~     second arm will receive the toolkit, web access, periodic audit and feedback reports of~     antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the~     AHRQ atypical antipsychotic CERSG to prescribers; and NHs in the third arm will receive the~     previous items plus face-to-face academic detailing. Primary outcomes of the evaluation are~     the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and~     maintenance).The investigators will also include an assessment of facility-level changes in~     the use of atypical antipsychotic drugs.~   "
130475|NCT01347606|"~     Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction~     and vascular or neural (such as recurrent nervus) injuries are most important ones. This~     research is aim to prevention of these via intraoperative methylene blue using.~   "
130476|NCT01347593|"~     Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.~   "
130477|NCT01347580|"~     The aim of this study is to determine whether initiation of ticagrelor as early as in the~     ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore~     facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the~     patient.~      The study will assess the efficacy and safety of pre-hospital compared to in-hospital~     administration of ticagrelor in co-administration with aspirin, on restoring the blood flow~     in the occluded heart artery and improving the myocardial perfusion in patients suffering~     from myocardial infarction and planned to have a PCI. Patients can be randomised in either~     one of the 2 arms:~      re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for~     the pre-hospital administration and placebo for in-hospital administration.~      or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital~     administration and 180 mg ticagrelor loading dose for in-hospital administration.~      Patients are initially managed by ambulance physician/personnel in pre hospital settings.~     They are then transferred into a Catheterization room to undergo a PCI.~      After the administration of the loading dose of ticagrelor (double blind), patients will~     continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.~   "
130478|NCT01347567|"~     The purpose of this study is to determine if heart failure subjects whose treatment is~     assisted by home BNP measurements integrated into a home health management system will have~     better clinical outcomes than subjects whose treatment includes home health management~     without BNP or than subjects treated by standard care.~   "
130479|NCT01347554|"~     Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was~     derived from studies comparing EES with bare metal stent (BMS) or EES with~     paclitaxel-eluting (PES). Although sirolimus-eluting stents (SES) have been shown to be the~     most efficacious drug regarding inhibition of neointima and late loss, there have been no~     previous head to head comparisons between EES and zotarolimus-eluting stent (ZES). Both~     everolimus and sirolimus are macrocyclic lactones that target the mTOR (mammalian target of~     rapamycin) to reduce vascular smooth muscle proliferation after vessel injury and therefore~     in principle may show similar results after stenting in humans. Data pooled from the EES arm~     that received follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS~     trial show similar rates of binary restenosis and late loss. However, the stent and polymer~     platform is not the same between the EES and ZES and it is reported that the EES system has~     the thinnest stent + polymer thickness (88.6um) of all of the previously KFDA-approved~     drug-eluting stent (DES). In addition, there are no data available on the efficacy of the~     EES and ZES in real world lesions other than the selected lesions studied in the previous~     trials, such as acute myocardial infarction.~   "
130480|NCT01347541|"~     This pilot study will evaluate the implementation of a stepped care intervention that~     combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications,~     and information technology innovations at a level 1 trauma center to community linkage~     components to reduce the symptoms of posttraumatic stress disorder and related comorbidities~     in injured trauma survivors treated in the emergency department and surgical inpatient~     settings.~   "
130596|NCT01346033|"~     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of~     subjects who have been diagnosed with Type 2 diabetes.~   "
130482|NCT01347515|"~     Hypothesis: A functional olive oil tailored to provide the best relationship between~     phenolic compounds (amount and type) phenolic bioavailability and bioactivity (antioxidant~     and anti-endothelial dysfunction) will be a useful tool for increasing not only circulating~     HDL cholesterol concentration, but also the functionality (antioxidant, anti-inflammatory,~     and reverse cholesterol transport capacity) of human HDL in vivo.~   "
130483|NCT01347502|"~     Using smartphone is increasing in hospital with various purpose and it has more extended~     surface than non-smart phone. Therefore investigators can consider the bacterial~     contamination rate of smartphone will be higher than that of non-smartphone.~   "
130484|NCT01347489|"~     There is no exact scientfic data about gender relationship with cronic pressure wounds~     (CPW). This research is aimed first to reveal gender relationship with CPW and aimed~     secondarily to reveal the gender related couse(es).~   "
130485|NCT01347476|"~     Patients aged 70 years or older had a higher possibility of high risk cancer than younger~     patients.~   "
130486|NCT01347463|"~     Traditional teaching that suggests the ipsilateral nipple as the directional guide for~     needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.~      The investigators attempt to validate this long-standing statement.~   "
130487|NCT01347450|"~     Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these~     compounds have displayed both in vitro and in vivo antioxidant activity.~      Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and~     cocoa powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative~     conditions.~      Design: Single-blind, controlled and randomized clinical trial including 100 healthy men,~     divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark~     chocolate/d for 1 wk, and the other 50 subjects received placebo.~   "
130488|NCT01347437|"~     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,~     when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy.~     However, adherence among HIV-infected young people is suboptimal, and few interventions are~     available to help adolescents adhere to treatment.~      The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted~     form of the Life-Steps behavioral intervention) to improve medication adherence among~     HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability~     to recruit, feasibility of intervention delivery with study counselors and all study~     procedures, and initial clinically significant improvement in medication adherence via MEMS~     caps. This research will lay the groundwork for a federal grant application for a multi-site~     randomized controlled intervention trial.~   "
130489|NCT01347424|"~     Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion~     liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow~     perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus~     paclitaxel and carboplatin regimen.~   "
130490|NCT01347411|"~     The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is~     enough scientific evidence that supports the association between apnea-hypopnea syndrome~     (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of~     this study is to estimate the effectiveness of the continuous positive pressure airway~     (CPAP) in patient with chronic heart failure with normal ejection fraction but dyastolic~     dysfunction and sleep disordered breathing during the sleep.~   "
130491|NCT01347398|"~     The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so~     we need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the~     assessment of respiratory events by measuring the flow ventilation with a nasal cannula~     connected to a pressure transducer.~   "
130492|NCT01347385|"~     The objective of this study is to determine if the use of a new type of barbed suture~     material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional~     approach of suturing with conventional suture material to close the uterine defect once the~     fibroid has been removed, improves surgical outcomes. Specifically, the investigators will~     investigate the effect of barbed suture on operative time, blood loss, adverse~     post-operative events and hospital stay.~   "
130493|NCT01347372|"~     Peer support (including informational, emotional, appraisal support) has been shown to help~     persons with chronic conditions. The goal of this research is to examine the impact of early~     peer support on the health and quality of life of individuals with early inflammatory~     arthritis (EIA). The investigators hypothesize that early peer support will result in~     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,~     self-efficacy, coping efficacy, social support, health-related quality of life,~     self-management, and disease activity score as well as reduced anxiety for individuals with~     EIA within 2 years of their diagnosis. In this study, persons with IA will be trained as~     peer mentors using a training program developed for a pilot study. Individuals with EIA will~     be randomized to receive either peer support program or standard care. Peer mentors will~     be paired with a person with EIA to provide one-on-one support (face-to-face or telephone)~     once a week for approximately 30 minutes over a 12-week period. All standard care~     participants will receive the peer mentoring intervention at the end of study. Both groups~     will be evaluated using self-administered questionnaires and clinical assessments, and~     results of the two groups will be compared. This information will be used to design a larger~     study.~   "
130521|NCT01347008|"~     Early phases of systemic sclerosis is characterized by inflammatory and microvasculature~     alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance~     vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on~     hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.~   "
130522|NCT01346995|"~     The purpose of this study is to evaluate the effects of experimental knee pain on the muscle~     strength gain after 8 weeks of strengthening exercises for the quadriceps. It is~     hypothesized that experimental knee pain will reduce the muscle strength gain following~     strengthening exercises in healthy volunteers.~   "
130523|NCT01346982|"~     This is a clinical trial to characterize drug interactions between silimarine and the~     protease inhibitor darunavir/ritonavir.~   "
130524|NCT01346969|"~     The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing~     skin scarring in subjects undergoing revision of scars from prior surgery. The study will~     also evaluate the safety and tolerability of EXC 001 and placebo.~   "
130494|NCT01347359|"~     Peer support (including informational, emotional, appraisal support) has been shown to help~     persons with chronic conditions. The goal of this research is to examine the impact of early~     peer support on the health and quality of life of individuals with early inflammatory~     arthritis (EIA). The investigators hypothesize that early peer support will result in~     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,~     self-efficacy, coping efficacy, social support, health-related quality of life,~     self-management, and disease activity score as well as reduced anxiety for individuals with~     EIA within two years of their diagnosis. In this study, persons with IA will be trained as~     peer mentors using a training program developed for a pilot study. Individuals with EIA will~     be randomized to receive either peer support program or standard care. Peer mentors will~     be paired with a person with EIA to provide one-on-one support (face-to-face or telephone)~     once a week for approximately 30 minutes over a 12-week period. All standard care~     participants will receive the peer mentoring intervention at the end of study. Both groups~     will be evaluated using self-administered questionnaires and clinical assessments, and~     results of the two groups will be compared. This information will be used to design a larger~     study.~   "
130495|NCT01347346|"~     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell~     genetherapy for the Wiskott-Aldrich Syndrome.~   "
130496|NCT01347333|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy for the treatment of liver metastases and unresectable~     primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.~   "
130497|NCT01347320|"~     The investigators want to evaluate if preoperative MRI improves the surgical results,~     especially in respect to surgical margins. The impact on the surgical procedure will be~     evaluated.~      In addition the investigators will examine the accuracy of tumor detection, localization and~     staging.~   "
130498|NCT01347307|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine~     tumors.~   "
130499|NCT01347294|"~     The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and~     bleomycin and fibrovein in the treatment of venous malformation.~   "
130500|NCT01347281|"~     The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with~     [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with~     blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4~     PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after~     treatment.~   "
130501|NCT01347268|"~     Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation~     induction and is a life threatening iatrogenic complication. In patients with GnRH agonist~     protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated~     with a reduction in (E2) levels with subsequent decreasing the incidence and severity of~     OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which~     GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients~     at risk of severe OHSS.~   "
130502|NCT01347255|"~     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous~     spray ointment, using the psoriasis plaque test modified from the method developed by KJ~     Dumas and JR Scholtz.~   "
130503|NCT01347242|"~     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell~     genetherapy for the Wiskott-Aldrich Syndrome.~   "
130504|NCT01347229|"~     The purpose of the study is to evaluate changes in intraocular pressure (IOP) between~     sitting and supine body positions and correlate the values obtained with conventional~     tonometers to the output provided by the investigational device.~   "
130505|NCT01347216|"~     In view of the manifold options for mono- and combination therapy that have now emerged for~     patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can~     only provide part of the information needed for optimal management. In order to gather~     adequate data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry~     prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since~     May 2007. The internet-based registry fulfills high quality standards through several~     measures (planned minimum centre contribution of at least 10 patients per year, automated~     plausibility checks of data at entry, queries, monitoring with source data verification in~     >50% of participating centers). It can be applied, among further purposes, for quality~     assurance: individual centers can confidentially compare their results with the combined~     outcome of other centers and the recommendations from guidelines. It is expected that the~     register contributes to optimization of specific drug therapy for PAH and PH.~      Since July 2013, also children of any age can be documented (COMPERA-KIDS).~   "
130506|NCT01347203|"~     This will be a study existing of 4 periods, to evaluate for a single dose of 4 different~     tablets of DPOC-4088 the absorption and elimination from the body and the potential effect~     on blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the~     rate of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets~     in each period will be determined by chance but is known upfront.~   "
130507|NCT01347190|"~     Study to assess safety and tolerability of a single dose of study-drug administered to~     Cystic Fibrosis (CF) patients.~   "
130508|NCT01347177|"~     Adhesive bridges are becoming popular in patients with congenitally missing teeth and these~     are type of bridges that can be done with only minimal or with no preparation to replace the~     missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for~     the removal of tooth substance. Treatment for this type of bridges does not usually require~     anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with~     minimal cost and reduced chair time.~      The biggest issue is that high failure rate in the long term, and gray colour shining~     through the metal wing cemented onto the abutment tooth. This can compromise the aesthetical~     outcome. The aesthetical problem can be solved by the use of zirconia all ceramic material~     to construct the bridge.~   "
130525|NCT01346956|"~     Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure,~     electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements~     will be compare for any cardiovascular effects of a cigarette smoking on these parameters.~   "
130509|NCT01347164|"~     Black men who have sex with men (MSM) have the highest rates of HIV infection in the United~     States and represent a population in need of new HIV prevention interventions. Although 20~     to 40% of Black MSM are estimated to have female partners, no interventions tailored to the~     needs of Black MSM/W have been developed and rigorously evaluated. This project will~     develop, implement, and evaluate an individual-level intervention (ILI), titled RISE, that~     will assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection.~     This intervention will address the effect of individual level factors, interpersonal~     relationships including sexual, peer and family relationships, and socio-cultural influences~     on the sexual risk behaviors of MSM/W. The intervention will consist of six counseling~     sessions held between a trained counselor and participant, and will be guided by three~     theoretical perspectives: an ecological perspective of behavior, stress and coping theory,~     and social cognitive theory. The COLOURS Organization, the sole agency in Philadelphia~     dedicated to exclusively serving the Black LGBT community, will be a key collaborator in the~     development and implementation of the intervention. The evaluation design utilizes a~     randomized controlled trial to test the effectiveness of the proposed intervention. Chain~     referral, based on principles of respondent-driven sampling, will be used to recruit 250~     HIV-positive and HIV-negative Black bisexually-active men into this study.~      The specific aims of this research are to:~        -  develop a new theoretically-based individual-level HIV prevention intervention~          culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W;~        -  evaluate the intervention with a randomized control group design, using RDS to recruit~          250 Black MSM/W who do not inject drugs and who report recent unprotected sex;~        -  assess the efficacy of the intervention and test the intervention model through the~          collection of behavioral risk assessments and HIV and STD testing at three time points:~          baseline, immediately post-intervention and three-months post-intervention;~        -  examine and describe individual factors, interpersonal relationships and network~          factors, and socio-cultural factors that may affect risk behaviors for HIV infection~          and transmission among Black MSM/W;~        -  develop recommendations for recruiting Black bisexually-active men and providing them~          with targeted HIV prevention interventions.~      Evaluation data collection will be conducted using ACASI. Data analysis will include~     Repeated Measures ANOVA to make assessments of changes over time and intervention dose~     effects and structural equation modeling to assess causal associations between factors in~     the conceptual model. This proposed study has significance for increasing our understanding~     various types of factors that may affect sexual risk behaviors of Black MSM/W as well as~     potentially providing an important new tool for HIV prevention specifically targeting the~     needs and risk behaviors of Black MSM/W.~   "
130510|NCT01347151|"~     Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view~     with minimal cervical spine movement. This study wants to compare cervical spine movement~     during intubation when using these two devices. The C-spine motion will be recorded by using~     fluoroscopic video to measure the angular displacement of the vertebrae.~   "
130511|NCT01347138|"~     Depression in late life has been associated with losses in functioning and quality of life,~     mortality, and increased health care costs. Although late life depression can be~     successfully treated with antidepressant medication or psychotherapy, few older adults~     receive adequate trials of such treatment in community in Korea. Barriers, such as loss of~     loved ones, medical illnesses, and social stigma associated with depression, lack of social~     and financial support, to effective treatment of depression can be especially problematic~     for older adult. Screening has been valuable in overcoming barriers to diagnosis. Over 60~     year old community dwelling people will be screened for symptoms of four geriatric~     conditions (depression, dementia, urinary incontinence, and sleep disorder). Those who will~     be screened positive for each condition will be refer to clinic for diagnosis. Among them~     only those cases confirmed as depression by psychiatrists will be enrolled in this study.~     Enrolled patients will be randomly assigned to either case management or usual care~     conditions.~      The objective of the study is to test whether a system of screening, assessment, and~     follow-up provided by case manager improves in recognizing the target geriatric conditions~     (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.~   "
130512|NCT01347125|"~     This study is designed to evaluate the ImCardia safety and to demonstrate system~     functionality in patients undergoing AV replacement with respect to 36 months follow up.~   "
130513|NCT01347112|"~     Alcohol dependence is a significant and prevalent public health problem affecting~     approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively~     seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the~     high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high~     risk for both morbidity and mortality related to alcohol consumption and tobacco dependence.~     Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering~     alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently~     drinking alcoholic smokers.~      Varenicline is the most effective medication currently available for treating tobacco~     dependence. While some randomized trials have included recovering alcoholics, active~     alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the~     first such clinical trial in currently drinking alcoholic smokers. In addition to helping~     smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in~     rats. The goal of this proposal is to explore the potential efficacy of varenicline for~     treating tobacco dependence and reducing drinking among alcohol dependent smokers.~      The investigators hypothesize that 12 weeks of treatment with varenicline, a partial~     nicotinic acetylcholine receptor agonist will be more effective than placebo in treating~     tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic~     smokers. The investigators will also explore whether varenicline has an effect on drinking~     behavior among currently drinking alcoholics. The investigators propose the following~     specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited~     at the Mayo Clinic in Rochester, Minnesota.~   "
130514|NCT01347099|"~     Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder~     (OCD) but there is a lack of properly trained CBT therapists. One possible treatment~     alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study~     was therefore to evaluate ICBT for OCD.~   "
130515|NCT01347086|"~     The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and~     Caucasian healthy male volunteers administered BI 207127 NA.~   "
130516|NCT01347073|"~     This non-randomized, open-label study was approximately one year in duration and consisted~     of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a~     12-month long term treatment period involving monthly visits.~   "
130517|NCT01347060|"~     The objective of this study is to compare healthcare utilization and costs in~     Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol~     xinafoate combination or inhaled corticosteroids in a typical clinical practice using a~     retrospective observational cohort study design of large managed care database. Outcomes on~     interest include asthma related severe exacerbations defined as asthma related emergency~     department visits, hospitalizations or combined emergency department/hospitalization. Other~     outcomes of interest include use of albuterol, oral corticosteroids and overall asthma~     related costs. Outcomes of interest will be compared between the two treatment cohorts~     (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids).~     Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox~     regression hazards analysis assessing time to first event for each asthma related endpoint~     adjusting for differences in baseline demographics such as age, gender, previous asthma~     medication use, co morbidities, costs, and plan demographics. Total asthma related costs~     will also be compared using generalized linear models adjusting for baseline differences.~   "
130518|NCT01347047|"~     1. Creating a population-based registry system Amyloidosis prospective epidemiological~          survey~             -  risk factors~             -  diagnosis~             -  prognosis~             -  treatment~             -  monitoring~             -  survival~        2. Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de~          Buenos Aires.~        3. Describe the characteristics of clinical presentation, evolution and predisposing~          factors of amyloidosis.~   "
130527|NCT01346930|"~     The MUSIC OL study is an open-label extension study, in which all eligible patients having~     completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once~     daily. The study objective is to assess the long-term safety and tolerability of macitentan~     in patients with idiopathic pulmonary fibrosis (IPF).~   "
130528|NCT01346917|"~     The purpose of this study is to determine whether intravenous lidocaine increase the~     tolerability of early oral feeding after laparoscopic colorectal surgery in patients with~     colorectal cancer.~        -  Degree of nausea/vomiting.~        -  Degree of postoperative pain and opioids requirement.~        -  Time to first flatus, time to first stool, time to tolerance of regular diet, rate of~          postoperative complications and duration of postoperative hospital stay.~   "
130529|NCT01346904|"~     Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across~     optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex;~     the neural degenerations could be identified through the whole visual tract, which suggests~     the central nerve system may play a vital role in the progression of glaucoma. The~     investigators used MRI to investigate changes of visual pathway in vivo.~   "
130530|NCT01346891|"~     The purpose of this study is to detect if there are any differences in the coding region of~     SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides,~     and those thiazides consumers without hyponatremia that have demonstrated good tolerance to~     the drug.~   "
130531|NCT01346878|"~     This study aims to analyze the association between the baseline detection of resistance~     mutations through Ultra deep Sequencing (UDS) and the virological outcome of salvage~     antiretroviral therapy, in comparison with conventional genotypic resistance tests. Based on~     the data generated in this study, new resistance interpretation tools and algorithms will be~     developed to improve the prediction of antiretroviral therapy outcomes. The final aim of the~     study is to improve the clinical care of HIV-1-infected patients through the incorporation~     of improved new antiretroviral resistances tests in the clinical practice.~   "
130532|NCT01346865|"~     The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase~     4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual~     antiplatelet therapy in patients treated with DES for Coronary Artery Disease.~      The primary objective of this study is to compare the safety and efficacy of triple~     antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with~     drug-eluting stent (DES) implantation for the treatment of coronary artery disease.~   "
130533|NCT01346852|"~     The purpose of this study is to assess the predictive ability of three asthma risk markers:~     the ratio of controller medication to total asthma medication, an albuterol only marker, and~     an oral corticosteroid use marker, as well as to compare the precision of these tools~     between adult and pediatric patient populations. This retrospective longitudinal analysis~     will use 2 different databases: a large managed care database and a large fee for service~     Medicaid database.~   "
130534|NCT01346839|"~     Diagnostic delays in ambulatory care are often due to breakdowns of related care processes.~     Electronic systems can improve follow-up and reduce delays by detecting missed appointments~     or incomplete procedures so that patients are called back to conduct timely investigations~     when appropriate. To achieve high standards of patient safety in cancer diagnosis, the~     investigators not only need to use information technology appropriately but also improve the~     processes, policies, and procedures of monitoring, communication, and coordination of care.~      Given the importance of cancer-related diagnostic delays in ambulatory care, the~     investigators need effective methods to detect them, understand their causes, and intervene~     to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and~     random chart reviews, have limited effectiveness. Our proposed study focuses on testing~     methods to proactively identify delays using certain triggers as they occur and intervene~     in a timely manner.~   "
130535|NCT01346826|"~     This study aims to test the hypothesis that the accelerated infusion of infliximab is not~     inferior to the conventional 2 hour infusion with respect to the frequency of infusion~     reaction.~   "
130536|NCT01346813|"~     Sick or premature neonates are exposed to frequent painful and stressful procedures during~     their stay in neonatal intensive care units. Although neonates do feel pain and may have~     long term effects induced by painful experiences, prevention and treatment of neonatal pain~     is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal~     and pediatric intensive care units in France in 2005 showed that painful procedures were~     extremely frequent and that analgesics treatments varied a lot among units. Since many~     guidelines have been issued by international scientific societies to manage neonatal pain,~     one may expect that the prevention and treatment of neonatal pain has improved over the last~     6 years.~      Although awake endotracheal intubations are extremely difficult or impossible in older~     children or adults, such intubations are still frequently performed without~     sedation/analgesia in neonates. Recent studies have shown that premedications facilitate~     intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed~     at assessing the risks and benefits of different sedations/analgesia strategies are urgently~     needed in neonates. We also need a tool to assess at the same time the technical conditions~     of intubations and the tolerance of the neonate to the procedure so that data from different~     studies can be compared.~      The objectives of the present study are:~        1. To describe the incidence of painful and stressful procedures performed in the neonate~          in intensive care units as well as in neonates transported by the medical emergency~          system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study~          conducted in the same region and same type of population in order to assess the~          evolution of practices. The description of painful and stressful procedures will be~          completed with a real-time around-the-clock assessment of the pain induced by~          procedures using a validated behavioral pain scale.~        2. To link this study with The Epipage study 2 in order to look for associations between~          the number of painful and stressful procedures and/or analgesic treatments of the~          neonatal period and the neurological outcome of children that will be followed in the~          Epipage cohort. The Epipage study is a separate study that will follow for 13 years a~          cohort of premature neonates recruited in 2011.~        3. To describe the incidence of painful or stressful procedures and analgesic treatments~          in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France~          region in France.~        4. To obtain initial validity of a tool permitting to assess intubations in neonates. An~          observational detailed description of endotracheal intubations conditions will be~          conducted in neonates transported and intubated by SMUR and in neonates intubated in~          intensive care units~        5. To describe continuous sedation and analgesia practices in ventilated neonates in~          intensive care units. For these neonates, data from medical records will be recovered~          up to 2 months of admission in intensive care units~        6. To describe the frequency of heel sticks for glycemia measurement and blood gazes~          practices among centers. Relate heel stick practices to the normality or abnormality of~          glycemia results~   "
130545|NCT01346696|"~     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 6 mm~     implants in a Chinese population by evaluation of marginal bone level alteration, implant~     stability and implant survival in the posterior mandible and maxilla up to 3 years after~     loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the~     posterior region is safe and predictable.~   "
130546|NCT01346683|"~     To investigate the clinical efficacy of Osseospeed™ TX implants in a Chinese population by~     evaluation of marginal bone level alteration, implant stability and implant survival in the~     posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior~     mandible is a safe and predictable procedure.~   "
130711|NCT01343550|"~     The investigators hypothesize that a creativity skills group for Borderline Personality~     Disorder can reduce symptoms of BPD, depression, and anxiety.~   "
130537|NCT01346800|"~     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit~     multiple known risk factors for CVD. Of specific concern is the fact that use of the non~     nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug~     classes is associated with dyslipidemia known to increase the risk of coronary heart disease~     particularly among older subjects with normalized CD4 cell counts and suppressed HIV~     replication. HIV patients could thus potentially receive anti-aggregant therapy~     concomitantly with their antiretroviral treatment. Prasugrel is an anti-aggregating agent~     indicated to prevent the recurrence of ischemic events after coronary arteries stenting. It~     is a pro-drug mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent~     by CYP2C9 and 2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in~     anti-HIV therapy. The aim of the present study is to assess the potential drug-drug~     interaction between prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers~     will receive prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on~     prasugrel pharmacokinetics will be assessed. The two sessions will be separated by a~     one-week wash out period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be~     assessed by a micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen~     and omeprazole. The pharmacokinetics of prasugrel active metabolite will be assessed during~     the two sessions.~   "
130538|NCT01346787|"~     The purpose of this study is to determine whether the association of Carfilzomib,~     Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides~     benefits in patients with newly diagnosed Multiple Myeloma (MM).~   "
130539|NCT01346774|"~     Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter~     associated urinary tract infection (CAUTI) in the post operatory period, as bladder~     catheterization is a common practice in gynecologic surgery. Cranberry products provide~     alternative means for preventing CAUTI and could result in decreased use of antimicrobials.~     In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to~     take either cranberry powder capsules or placebo powder capsules. The low risk of harm~     associated with using cranberry to reduce UTI coupled with its potential benefit makes it a~     desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot~     /feasibility study will prepare us for the conduct of a large scale clinical trial.~   "
130540|NCT01346761|"~     Individuals living in geographically underserved areas encounter considerable barriers to~     access of quality cancer genetic services. Although in-person genetic counseling has~     generally been accepted as the standard of care, the use of telecommunications to deliver~     clinical genetic services may help reduce this disparity in access to such services.~     However, before the widespread adoption of telephone-delivered cancer genetic services~     occurs, it is critical to analyze the efficacy and safety of this mode of communication.~     This two-group randomized equivalency/non-inferiority trial will determine whether~     telephone-based cancer genetic counseling is an acceptable alternative to the traditional~     in-person mode among women who have a personal or family history of breast and/or ovarian~     cancer strong enough to warrant genetic counseling and testing. This study's findings will~     provide important information to cancer centers and cancer control policies about the~     safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services~     for geographically challenged women at risk for having Breast Cancer susceptibility gene~     (BRCA) 1/2 mutations.~   "
130541|NCT01346748|"~     Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and~     mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in~     the last years. Phase II randomized clinical trials have demonstrated that statin decreases~     the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage.~     Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though~     some articles have shown that statins provide better prognosis, some issues remain in~     debate, e.g., treatment duration and the choice of the statin.~   "
130542|NCT01346735|"~     Most literature on ICU infections and the resistant patterns comes from the western~     literature. This data may not truly reflect the incidence, epidemiology and resistance~     patterns in developing countries such as India. However, empiric antibiotic therapy is~     generally initiated using western guidelines. This can potentially lead to inadequate,~     inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian~     setting. Hence in this multi-center observational study, we seek to:~        1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India~        2. To explore the microbiology, resistance and treatment patterns of these infections~   "
130543|NCT01346722|"~     It is well documented that zinc supplementation to low-income population results in the~     reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted~     children. Implementation of large scale programmes are needed for prevention of zinc~     deficiency in areas where it is common. In Bangladesh, the risk of zinc deficiency is~     considered to be high and children could benefit greatly by improving their zinc intakes on~     a daily basis. Zinc supplementation at a national scale would be a formidable task and even~     if implemented might not be sustainable in the long range. There thus is a need to find an~     alternative. It might be sustainable to improve intake of zinc through fortified staples,~     e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed~     through conventional breeding, which is designed to contain an amount of zinc that could~     meet at least 40% of the daily requirement.~      To assess the potentials for biofortified rice in providing a good, bioavailable source of~     additional zinc, the investigators propose to measure zinc absorption from rice-based meals~     among Bangladeshi preschool children. Specifically, the investigators will measure the~     amount of zinc absorbed from zinc-biofortified rice (Diet-ZBfR, 24 mg Zn/kg), compared to~     that absorbed from a conventional Bangladeshi rice (Diet-CR, 16 mg Zn/kg) (control). The~     investigators will also compare the zinc absorption from biofortified rice with that from~     zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized,~     controlled clinical study. In total, 42 children aged 36-59 months of either sex will be~     recruited from a peri-urban community in Dhaka, and they will be individually randomized, in~     equal numbers, to one of the two comparison groups, A and B. The group A children will~     receive zinc biofortified rice-based diet (Diet-ZBfR) and conventional rice-based diet~     (Diet-CR) using a randomized, cross-over design. Similarly, the group B children will~     receive zinc biofortified rice-based diet (Diet-ZBfR) and a zinc fortified rice based diet~     (Diet-CR+Z), also using randomized, cross-over design. The investigators will use zinc~     stable isotope tracer techniques to measure the fractional absorption of zinc, in which~     tracer : tracee ratios will be measured in spot urine samples following administration of an~     intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided~     with test meals over a two-day period. If zinc from biofortified rice is found to be~     adequately bioavailable, it will be tested in a randomized, controlled, efficacy trial among~     rural Bangladeshi children.~   "
130544|NCT01346709|"~     Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe~     (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort~     of patients undergoing a nonobstetric in-hospital surgical procedure under general or~     regional anaesthesia during a continued 7-day period of recruitment.~   "
130712|NCT01343537|"~     Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a~     serious condition with a high morbidity (incidence of having ill health) and mortality~     (death). There are approximately 11 cases per 100,000 in the population per year, and~     approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who~     survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity.~     Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing~     that occurs after bleeding into the subarachnoid space, most commonly after aneurysmal~     rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain~     of oxygen, which often results in a stroke.~      Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage.~     For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent~     deficits develop.~      There may be another option to solve this dilemma. The field of neuro-monitoring~     (neurological monitoring) has the technology available to continuously monitor brain~     activity of these sedated ICU subjects. This may allow for early diagnosis and possibly~     identify changes in neurologic function before they become symptomatic. In the past,~     neuro-monitoring was primarily used in the operating room to monitor neurologic function~     during surgery in and around the spinal cord. Surgery to the spine or spinal cord also~     carries its own form of risk, either from mechanical trauma to the spinal cord or its nerve~     roots, or from interruption of the blood supply to these structures. Should damage to nerve~     fibers occur, the end result could be paralysis, loss of sensation, and onset of severe~     burning (i.e. neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was~     developed to address these risks during spine surgery, whereby nerves rostral (toward the~     head) or caudal (toward the feet) to the site of surgery are stimulated (usually via~     electrical pulses) and signals are recorded from the side opposite to the site of~     stimulation. Thus, the signals carried by nerve fibers are forced to pass through the region~     at risk from the surgery. In the event that changes in nerve responses are seen, the~     surgical team is notified, and they can change what they're doing to try and restore~     signals, thereby preserving function in the nerve fibers.~      This same technology has been used in the neurosurgical ICU to monitor subjects with severe~     brain injury from trauma, stroke, intracranial hemorrhage and subarachnoid hemorrhage. Using~     continuous electroencephalogram (EEG) monitoring combined with somatosensory evoked~     potentials (SSEPs) (a type of neuro monitoring) has been used to determine prognosis,~     identify subjects in subclinical status epilepticus (state of brain being in a constant~     seizure), predict elevations in the intracranial pressure Increased pressure within the~     skull), and diagnose cerebral hypoxia (not enough oxygen in the brain) (Amantini)~   "
130549|NCT01346644|"~     In the last years manipulation of intestinal microbiota with probiotics has gained an~     increasing interest, specially in infant nutrition since recent studies has demonstrated the~     presence of probiotics in human milk. However, there are few studies studying the effects of~     probiotics in newborns. The objective of the present study is to analyze safety and~     tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.~   "
130550|NCT01346631|"~     Prospective studies concerning diet and male fertility are lacking. Observational studies~     suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm~     counts. The investigators wanted to see if a paleolithic diet consisting of meat, fish,~     fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm~     counts.~   "
130551|NCT01346618|"~     Bone age assessment is currently an important tool in final height implication in children.~     It is an important tool in the phases of investigation and treatment of short stature, tall~     stature, pubertal timing and various endocrinological pediatric situations. It is currently~     assessed using hand x-ray. This method has several limitations, including: requirement of~     specialized medical staff to interpret results, exposure radiation and usage of equipment~     which is only in radiology centers. The investigators aim to study a new equipment,~     radiation free, with simple and swift operation which provides an immediate answer, no need~     for an experienced observer, a mobile equipment with easy accessibility. The aim of the~     study is to assess its reproducibility, validity and safety compared to the x-ray method.~      The investigators hypothesize it is as accurate and valid.~   "
130552|NCT01346605|"~     This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion~     (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical~     facilities. The study uses an electronic data capture tool to collect the de-identified data~     to create a global multi-center registry. This registry will be used for scientific analysis~     and publication of pertinent medical trends such as CT utilization, radiation dose, and~     common cardiovascular findings.~   "
130553|NCT01346592|"~     This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted~     Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza~     Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <~     72 Months of Age.~   "
130554|NCT01346579|"~     This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic~     subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I~     breast cancer. Studying samples of tissue from patients with stage I breast cancer in the~     laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid~     (DNA) and identify biomarkers related to cancer.~   "
130555|NCT01346566|"~     The purpose of this study is to report the intraoperative performance and postoperative~     outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated~     lenses.~   "
130556|NCT01346553|"~     The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous~     Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way~     venous valve and a sensor that identifies the movement of the calf muscles pump. The~     external device is located above the failed deep vein and exerts synchronized intermittent~     regulated pressure on it. Alteration in the vein structure is occurred and the blood flows~     in the cephalad direction, preventing the return toward the feet. The device is synchronized~     with the calf muscles pump to function as a one-way venous valve. This study was design in~     order to assess safety and efficacy of using the ESVV for treatment of consequences of deep~     chronic venous insufficiency.~   "
130557|NCT01346540|"~     The LUME-Lung3 study is in 2 parts:~      Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that~     can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and~     cisplatin.~      Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles~     of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2~     previous courses of the chemotherapy~   "
130558|NCT01346527|"~     Background: The health of the next generation is likely programmed in the womb (i.e.in~     utero), and our understanding of how that programming happens will allow us to favorably~     influence the health of future generations. The focus of this proposal is to examine the~     effect of in utero programming on heart function in children born to women with type 2~     diabetes (T2DM). Specifically, neonates born to diabetic women have abnormal heart structure~     and weaker heart function at birth, which may predispose them to long-term heart problems in~     childhood, adolescence and adulthood. At present, the reason for these heart abnormalities~     in children born to women with diabetes is unknown and is the focus of this proposal.~      Objective(s) and Hypothesis(es): The objectives are to examine the relationships among~     maternal lipid (fatty acid, triglyceride, very low density lipoprotein) metabolism and~     neonatal heart structure and function in diabetes and to identify clinical markers during~     pregnancy for heart dysfunction in infants born to diabetic women. The overall hypothesis is~     that maternal lipid metabolism is abnormal in diabetes, and this metabolic dysregulation~     increases fatty acid delivery to the fetus in utero and leads to abnormal accumulation of~     lipid in the fetal heart, resulting in altered neonatal heart structure and function in~     infants born to diabetic women. In addition, the investigators hypothesize that decreased~     maternal fatty acid oxidation (fat burning) rate, elevated lipolytic (fat breakdown) rate~     and elevated blood total free fatty acid level predicts abnormal neonatal heart structure~     and function in infants born to women with type 2 diabetes.~      Methods and Procedures: The investigators will test these hypotheses by using clinical~     metabolism studies (infusion of stable isotope labeled fatty acid, serial blood and breath~     sampling, and mass spectrometry) to quantify whole-body fat (fatty acid oxidation,~     lipolysis, and serum fatty acid , triglycerides, VLDL-cholesterol levels) metabolism in 25~     diabetic women during the 3rd trimester of pregnancy, and compare these lipid metabolism~     kinetics to 25 body mass index matched healthy non-diabetic women during pregnancy and~     determine if alterations in maternal lipid metabolism predict abnormal neonatal heart~     function in children born to these women.~      Potential Impact: Type 2 diabetes is an epidemic in the United States and is steadily~     increasing worldwide. Diabetes has detrimental health effects in pregnant women and in their~     offspring. The investigators know that children born to women with diabetes have an~     increased risk for developing diabetes, obesity and cardiovascular disease, than children~     born to healthy women. This proposal will address an important knowledge gap regarding the~     role of maternal lipid (and potentially other nutrients) metabolism on the cardiovascular~     health of the global and increasing population of children born to diabetic women. Findings~     from this project will be novel and innovative, and will likely point to clinical~     interventions that target and correct lipid and other metabolic abnormalities in women with~     pre-gestational diabetes. The impact will be great because the long-term goal is to~     ameliorate heart problems in children born to diabetic (both pre-gestational and~     gestational) women. In addition, this project will establish a small cohort of children that~     can be followed long-term to address novel questions about the progression of heart and~     other metabolic abnormalities in children born to diabetic women.~   "
130559|NCT01346514|"~     The study examined intensive case management for homeless Veterans in addiction treatment by~     integrating addiction/housing case managers (AHCM), operating from a Life Skills Training~     perspective, into an addiction specialty program. The primary aim was to determine whether~     the AHCM intervention increases number of days housed during the year following treatment~     entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and~     attention control, determine if AHCM improves addiction outcomes and functional status, and~     examine treatment process variables associated with improved outcomes.~   "
132224|NCT01324479|"~     This study will assess the safety and efficacy of INC280 in patients with solid tumors that~     are refractory to current treatment or for which there is not a current standard of care and~     whose tumors have dysregulation of the c-MET pathway.~   "
130561|NCT01346488|"~     Study Objectives~      As special investigation (PMOS/non-mandatory) of HUMIRA® subcutaneous injection 40 mg~     syringe 0.8 mL (generic name: Adalimumab) will be performed to examine the following (1) and~     (2) for correlation between baseline and follow-up by clinical observation 48 weeks (planned~     visit time; before the start of treatment, and at 12, 24, 36, and 48 weeks, 4 data~     collection points) in Japanese rheumatoid arthritis patients who are engaged in paid work~     and home work.~        1. The primary objective; Situation of work productivity using the Work Productivity and~          Activity Impairment/General Health questionnaire and functional impairment (daily life~          activity) using the Modified Health Assessment Questionnaire when HUMIRA® treatment.~        2. The secondary objective; Clinical observation and rate of improvement of the Disease~          Activity Score 28 when HUMIRA® treatment. Situation of the occurrence of adverse events~          definition during the course of the observation period while HUMIRA® treatment, other~          factors considered to affect the safety and effectiveness.~   "
130562|NCT01346475|"~     On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to~     NCT00362297. On 28 April 2011, the two records were split for administrative purposes and~     each trial was given its own unique study record. Please refer to the History of Changes~     on posting NCT00362297 for a detailed summary of the modifications.~      The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir~     compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in~     persons with genital herpes.~      The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by~     blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at~     least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and~     willing to stop taking suppressive therapy for HSV for the one week wash out period.~     (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked~     to use an effective form of birth control.~      Involvement in the study will last 11-weeks and you will be asked to visit the clinic every~     2-weeks. At each visit, you will be given medication to take daily (either once daily~     valacyclovir or high dose valacyclovir; you will receive both medications at some point~     during this study). We will ask you to give a blood sample for liver, kidney and blood count~     testing at each visit. There will be a total of 8 study visits and each visit will last~     approximately 30 minutes. We will ask that you complete a daily symptom diary and collected~     daily home swabs 4-times a day, everyday during the study. Each daily home swab will take~     less than 3 minutes to perform.~   "
130563|NCT01346462|"~     The investigators propose a pilot randomized controlled trial of a care transitions~     intervention in which trained Community Health Workers will act as supports for~     socioeconomically vulnerable patients who are being discharged from the Hospital of the~     University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help~     patients to overcome the challenges of transition, including arranging primary care provider~     (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based~     social services. As our primary outcome, the investigators will examine the effect of the~     IMPaCT intervention on rates of primary care follow-up. The investigators will also examine~     the effect of IMPaCT on secondary outcome variables including patients' satisfaction with~     the experience of transition, quality of discharge communication, medication adherence,~     self- rated health, and inpatient readmission within 30 days after discharge.~   "
130564|NCT01346449|"~     The purpose of the study is to better understand how individuals make decisions regarding~     the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant~     will be recorded over several weeks to study ordering habits over time. Lunch menus will be~     provided by the study, and the menu format will vary the way in which information on caloric~     content is displayed.~      The impact of different labeling formats on total calories in the chosen meal will be~     assessed.~   "
130565|NCT01346436|"~     The purpose of this randomized double blind controlled study is to assess the value of~     robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare~     perioperative and functional outcomes to the laparoscopic approach.~   "
130566|NCT01346423|"~     Musculoskeletal pain is very common in the normal population, and the reason for about 50 %~     of the long term sickness absence in Norway. Most of these patients have common, but~     troublesome subjective health complaints where pathological findings are absent or~     substantially less than expected compared to the reported intensity of the complaints.~     Psychosocial factors are important in the development of chronic complaints. In a large~     meta-analysis job satisfaction was found to be associated with mental health and subjective~     physical health. Individual factors are also important. Uncertainty related to the~     understanding of pain mechanisms, treatment strategies and management contribute to the~     problem.~      Among patients sicklisted for musculoskeletal complaints, low back pain is the largest~     diagnose group. Most of these patients also have many other complaints. Previous studies~     have shown that for low back pain patients a brief intervention at a spine clinic with~     examination, information, reassurance, and encouragement to engage in physical activity as~     normal as possible, had significant effect in reducing sick leave. Other studies have shown~     that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A~     Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for~     patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs,~     pain, and function.~      A treatment team consisting of various professionals is expensive, and in this study we will~     compare the simple, standardized brief intervention model with the more resource demanding~     interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.~      Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal~     complaints - is it beneficial for reducing sickness absence?~   "
130567|NCT01346410|"~     This study will evaluate the local control rate as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.~   "
130568|NCT01346397|"~     After alemtuzumab induction, followed with kidney transplantation, patients will be randomly~     assigned to receive either tacrolimus or cyclosporine microemulsion in combination with~     mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month~     posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr~     virus (EBV) and BK virus (BKV) in urine and blood.~      The investigation is undertaken to clarify the reason for equal survival rates for patients~     on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.~   "
130569|NCT01346384|"~     The purpose of this study is to investigate the time-related intracuff pressure and volume~     change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.~   "
130570|NCT01346371|"~     The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye~     drop on the quality of your tears.~   "
130571|NCT01346358|"~     A dose escalation study to establish the safety profile and characterize the pharmacokinetic~     profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to~     standard therapy or for which no standard therapy is available.~   "
130575|NCT01346306|"~     Among antidepressant treatments, ECT stands as the most effective in treating acute~     depression. However, patient concerns with the cognitive side effects of ECT have encouraged~     the development of new and more focal forms of brain stimulation such as transcranial Direct~     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the~     way that it is currently administered and this has raised interest in finding alternative,~     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS~     stimulation using an alternative electrode montage has antidepressant effects. Further~     sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood,~     cognitive test performance and biomarkers will be measured periodically in the duration of~     the trial.~   "
130576|NCT01346293|"~     The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® +~     IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico~     who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.~      Primary Objectives:~        -  To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA),~          Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean~          concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA])~          following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL®~          vaccination when administered as a 5th dose.~        -  To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA)~          following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL®~          vaccinations when administered as a 5th dose .~        -  To compare the Inactivated Poliovirus Vaccine booster responses (as measured by~          neutralizing assay) following DTap-IPV vaccination with those elicited following~          DAPTACEL® + IPOL® vaccinations.~      Observational Objectives:~        -  To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following~          DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.~        -  To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered~          as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL~          and/or Pentacel vaccines.~   "
130577|NCT01346280|"~     Background:~      -Coordinated cancer care provided by doctors, nurses, social workers, and other care~     providers is believed to improve patient and physician satisfaction and patient evaluation~     for enrollment in clinical trials. But no research has been done to show that this approach~     improves patient experiences and outcomes. Researchers want to study this model to better~     understand how it can improve cancer treatment and patient outcomes.~      Objectives:~      - To assess the relationship between coordinated care and cancer treatment processes and~     outcomes.~      Eligibility:~      - Individuals who are at least 18 years of age. Those who take part must have been diagnosed~     with colon, rectal, or non-small-cell lung cancer. They also must be receiving or have been~     treated at one of the 16 NCI Community Cancer Center program sites.~      Design:~        -  Researchers will collect medical records data from participants.~        -  Participants will complete a questionnaire about 8 weeks after the end of all planned~          cancer treatment. They will be asked questions about their experience with coordinated~          cancer care. They will also be asked for any comments or concerns they had during and~          after treatment.~        -  No treatment or additional tests will be provided as part of this protocol.~   "
130578|NCT01346267|"~     RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy.~     It is not yet known whether standard care is more effective with or without acupressure~     wristbands in controlling acute and delayed nausea.~      PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work~     with or without standard care in controlling nausea in young patients receiving highly~     emetogenic chemotherapy.~   "
130579|NCT01346254|"~     Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious~     complication after kidney transplantation. Patients who develop NODAT are at increased risk~     for loss of the transplanted organ and for diseases of the cardiovascular system.~      It is believed that in many patients the development of overt NODAT is preceded by a phase~     of impaired glucose tolerance that is called pre-diabetes.~      This study aims at improving glucose metabolism in patients after kidney transplantation who~     are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT)~     after kidney transplantation are randomized to either receive vildagliptin (Galvus),~     pioglitazone(Actos) or placebo for three months.~      The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to~     improved glycemic control compared to placebo.~   "
130580|NCT01346241|"~     The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA~     community based outpatient clinics (CBOCs).~   "
130581|NCT01346228|"~     The purpose of this study is to see if a new Smart Phone application can help Veterans~     manage their panic symptoms after completing a two-day treatment for panic attacks.~   "
130582|NCT01346215|"~     The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect~     and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.)~     compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under~     hemodialysis treatment.~   "
130583|NCT01346202|"~     Complex and chronified pain syndromes requires a specialized therapeutic concept. From~     patients with chronic low back pain the investigators know, that an interdisciplinary~     multi-modal approach may improve the therapeutic success. In this observational study the~     investigators investigated if the multi-modal pain therapy is also effective in patients~     with mixed chronic pain syndromes.~   "
130584|NCT01346189|"~     Using a 4-arm, cluster-randomized controlled trial, the investigators will test the~     effectiveness of different behavioral economic interventions in increasing statin use and~     reducing LDL cholesterol among patients with poor cholesterol control who are at very high~     risk for CVD. The investigators will test these approaches among primary care physicians and~     their patients at very high risk of CVD at Geisinger Health System and University of~     Pennsylvania outpatient clinics.~   "
130585|NCT01346176|"~     The investigators aim to assess the influence of default options in advance directives on~     older patients selections of life- extending therapies and to determine whether alerting~     patients to the spectrum of possible default options in advance directives influences their~     selections of life-extending therapies by manipulating the default options of advance~     directives given to patients in with severe respiratory disease~   "
130586|NCT01346163|"~     This study will look at the impact of dosing as well as ongoing treatment with an~     investigation medication identified as PF-03654746, on cognitive and physiologic indicators~     of brain function. Data from this study will assist with the evaluation of the utility of~     functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic~     measures in the detection of early signals of the effectiveness of medications developed to~     target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this~     population will be also be evaluated.~   "
130587|NCT01346150|"~     People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections~     as a result of inherited defects in the genes that normally instruct blood-forming cells to~     develop and to fight infections. PID diseases include Severe Combined Immune Deficiency~     (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated~     by transplantation of bone marrow stem cells from a healthy person or, in some cases, by~     enzyme replacement or by gene therapy. Patients with SCID were among the first to receive~     bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40~     years ago, and HCT is the standard treatment today for this group of diseases. Since PID~     diseases are rare, there are not enough patients at any single center to determine the full~     range of causes, natural history, or best methods of treatment. For this research study many~     PID centers across North America have organized into the Primary Immune Deficiency Treatment~     Consortium (PIDTC) to pool their experience and study PIDs together. Researchers will~     collect information on your general health, psychological and developmental health, and the~     current status of your immune system to help better define future approaches to PID~     treatments.~   "
130588|NCT01346137|"~     In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess~     its effect on follicular development and find out if this regimen delays or blocks ovulation~     while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg~     of meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous~     cycles. The 3 treatment cycles will be preceded and followed by control cycles with no~     treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound~     examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in~     multiple blood samples in each cycle. The investigators will recruit a total of 56 women.~     Each woman will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women~     assigned to each of the 2 dose regimens. Participating women will demonstrate an ovulatory~     cycle before starting meloxicam treatment and will be protected from pregnancy by prior~     sterilization.~   "
130589|NCT01346124|"~     There are two types of external radiation treatments; proton beam and photon beam radiation.~     What type of therapy participants will receive will depend upon the location of their tumor.~     Standard treatment would involve receiving either proton or photon radiation delivered by a~     three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a~     technique where the beams of radiation used in the treatment are shaped to match the tumor~     in order to avoid damaging the healthy surrounding tissue. Standard treatment also may~     include photon radiation delivered by intensity modulated (IMRT) technique. In this research~     study we are using an investigational technique to deliver proton radiation therapy called~     intensity modulated proton radiation treatment (IMPT) which is used to target cancer while~     sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned~     down during the treatment. This control over the intensity of the radiation dose has the~     potential to provide accuracy and allows us to more safely increase the amount of radiation~     delivered to the tumor. This accuracy may potentially reduce side effects that patients~     would normally experience with 3-D proton radiation therapy. Surgery is often an important~     component of the treatment for these tumors and may be integrated with the IMPT.~   "
130590|NCT01346111|"~     The purpose of the study is to generate and valid a co-morbidity score with updated~     definitions and suitable for use in Argentina in both public and private settings. These~     tools would allow us to compare different populations in Argentina adjusting for~     comorbidities. Also, this would potentially help attending physicians and health~     administrators.~   "
130591|NCT01346098|"~     The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic~     head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas~     and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation~     (IAT) is associated with a lower morbidity (in terms of surgical or medical complications)~     and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.~   "
130592|NCT01346085|"~     Our final objective is to develop an adoptive therapy with tolerogenic donor-specific Tr1~     cells in T1D patients undergoing pancreatic islet transplantation (Tx). The achievement of~     this objective depends by the availability of an immunosuppressive treatment (IS) compatible~     with the survival, function, and expansion of the transferred Tr1 cells. For this purpose~     the investigators design a CNI-free single-group, phase 1-2 trial excluding the ATG or~     anti-CD25 induction therapy after the 1st islet infusion~   "
130593|NCT01346072|"~     This study will investigate the association between levels of the peptide copeptin and~     response to tolvaptan, a drug that blocks the action of the water retaining hormone~     vasopressin.~   "
130594|NCT01346059|"~     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in~     patients after recent antibiotic use. The current standard of care treatment for severe C.~     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is~     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,~     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted~     mortality rate is 14% for severe infection. It is believed that the failure of treatment may~     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral~     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin~     functions by direct contact with the colon. Therefore, if the vancomycin is instilled~     directly into the colon, it can come into contact with and be its intended target. : The~     objective of the study is to improve treatment of severe C. diff. colitis . C. diff.~     infection is defined as severe if there is evidence of ileus accompanied by any one of the~     following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white~     blood cell count greater than 14,000.~   "
130595|NCT01346046|"~     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of~     subjects who have been diagnosed with Type 2 diabetes.~   "
130597|NCT01346020|"~     This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using~     different approaches and to identify a possible association with disease progression, i.e.~     therapy initiation.~        1. Samples This monocentric study is carried out using representative bioarchived leukemic~          samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived~          samples were collected locally at our center during years of diagnostic activity, and~          were accurately pathologically, cytogenetically and molecularly characterized.~        2. Clinical data The clinical data were retrospectively collected through collaboration~          with the referring physicians.~        3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2)~          fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the~          array data sets, significant results will be validated and in addition, results will be~          correlated with clinical data.~   "
130598|NCT01346007|"~     The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine~     safely induces immune responses and immunological memory in children with idiopathic~     nephrotic syndrome in remission.~   "
130599|NCT01345994|"~     This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine~     how this central fMRI biomarker is modulated by acupuncture. This study will also~     investigate the behavioral consequences of maladaptive cortical plasticity in this disease~     population.~   "
130600|NCT01345981|"~     To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40~     mg, and without lidocaine.~   "
130601|NCT01345968|"~     The primary purpose of this study is to evaluate the safety and efficacy of preoperative~     intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement~   "
130602|NCT01345942|"~     This open label, two period, crossover study will evaluate the safety and the effect of food~     on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy~     subjects will be randomized to receive a single oral dose of RO5428029 with or without food,~     with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days~     after last dose. Anticipated time on study will be up to 21 days.~   "
130603|NCT01345929|"~     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of~     CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the~     treatment of adults with a cUTI (including pyelonephritis).~   "
130604|NCT01345916|"~     The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the~     corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in~     terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.~   "
130605|NCT01345903|"~     This pilot clinical trial studies robotic-assisted surgery in treating patients with spine~     tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may~     have fewer side effects and improve recovery~   "
130606|NCT01345890|"~     The investigators aim is to try to rehabilitate post stroke dysphagia using electrical~     stimulation of the mylohyoid muscles.~   "
130607|NCT01345877|"~     Pain is a complex experience influenced by gender and genetics, and, by psychosocial and~     sensory experiences. Pain sensitivity is thus highly variable between individuals.~      In the present study we evaluate individuals´ pain perception in response to a number of~     different pain stimuli in 100 healthy volunteers (50 females and 50 males).~      The data will allow us to assess pain sensitivity, to predict pain responses and to~     investigate gender related differences in pain perception.~      A second aim is to evaluate the robustness of the different pain-tests since the tests are~     repeated with an interval of 2-4 weeks.~   "
130608|NCT01345864|"~     This study is designed to look at the potential for an investigational drug (PF-04995274,~     under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to~     reverse changes in memory and learning/problem solving skills caused by co-administration of~     a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in~     memory and learning/problem solving skills that are similar to those seen in people with~     alzheimer's disease(AD).~   "
130609|NCT01345851|"~     This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given~     together with hypofractionated RT boost and combination chemotherapy in treating patients~     with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT~     uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays~     directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving RT together~     with combination chemotherapy may kill more tumor cells and allow doctors to save the part~     of the body where the cancer started~   "
130610|NCT01345838|"~     A prospective case-control study of the clinical and radiographic outcome of periacetabular~     osteotomy in patients with and without preoperative acetabular labral tears.~   "
130611|NCT01345825|"~     The purpose and Study hypotheses:~      The purpose of the study is to investigate the effect of progressive resistance training in~     the early postoperative phase on patients who has had unicompartmental knee replacement. The~     hypotheses are that this group compared to a control group will achieve greater muscle~     strength and functional ability in terms of gait and working capacity.~      Study design:~      The subjects will be randomized into two groups; intervention and control. Intervention~     group: strength training two times a week supervised by a physiotherapist.~      Control group: Training at home, following extradited guidelines.~      Endpoint:~      Primary endpoint is two months postoperative. The following test will be used: muscle power~     test (by a Power Rig), instrumented gait analysis using a combined accelerometer and~     gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step~     test.~      Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.~      Sample size:~      The power calculation is based on an expected improvement in muscle power by 25%. The risk~     of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that~     24 patients are needed in both groups, but 30 patient will be included in both groups to~     account for dropouts.~      Perspectives:~      This study is, to our knowledge, the first study to investigate the effect of strength~     training after unicompartmental knee replacement. Moreover it has , to our knowledge not~     been. At the moment no guidelines for rehabilitation exist, and research showed that this~     group of patients has a decreased function in their daily living compared with the~     background population. If, as expected, cases have an overall increased function compared to~     controls, this study can provide a basis for future rehabilitation.~   "
130612|NCT01345812|"~     The primary purpose of the investigation is to identify differences in embryo development~     after follicle stimulation with two different gonadotrophins.~   "
130613|NCT01345799|"~     In Crohn's Disease Patients~        -  To evaluate the efficacy of TRK-170~        -  To evaluate the PK characteristics of TRK-170~        -  To assess the safety of TRK-170~   "
130614|NCT01345786|"~     For the contraceptive application a film-coated tablet has been developed which combines~     nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized,~     single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at~     two sites, one site per study part. The primary objective of Part 1 was to assess the~     bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process~     (commercial batch) versus the Phase 3 drug product (Batch A). The primary objective of~     Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using~     the commercial process (commercial batch) versus the Phase 3 drug product (Batch B).~   "
130615|NCT01345773|"~     Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of~     cancer patients. Several guidelines recommendations have been made about the use of~     anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In~     Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are~     strongly recommended to receive pharmacologic prophylactic anticoagulation such as low~     molecular weight heparin (LMWH) in the perioperative periods. These guideline~     recommendations are based on high incidence of postoperative VTE development in Western~     cancer patients. However, there have been many cumulative data about the effect of different~     ethnicity on the VTE development and more and more investigators and clinicians admit that~     Asian ethnicity has lower incidence of VTE than Western ethnicity. Therefore, it may not be~     advisable to apply Western guidelines as it is to the clinical situation of Asian cancer~     patients.~      Although gastric cancer is the common cancer in Asia, there is no prospective data on the~     incidence of VTE development during the postoperative period of gastric cancer surgery. In~     other words, Asian doctors including Korean clinicians don't know the exact incidence of~     surgery-related VTE. From their clinical experiences, most Korean surgeons think that the~     incidence of postoperative VTE development is rare. They also have much concern about the~     complications such as bleeding that might be caused by routine use of pharmacologic~     thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation,~     Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW.~     Considering these clinical situations in Korea, the uncritical acceptance of Western~     guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be~     answered only from the results of the prospective study on the incidence of postoperative~     VTE development after gastric cancer surgery. Moreover, current surgical trend in cancer~     patients is minimally invasive approach such as laparoscopic surgery. However, the necessity~     of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has~     not been evaluated even in Western countries. Western guidelines also cannot exactly answer~     whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving~     laparoscopic cancer surgery. On above backgrounds, this study was designed.~   "
130616|NCT01345760|"~     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in~     length, capable of post-transcriptional gene regulation. miRNAs bind to their target~     messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based~     on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in~     diverse developmental and cellular processes and linked to a variety of skin diseases and~     cancers. In the present study, the investigators examines the expression profiles of the~     microprocessor complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1,~     argonaute-2 and PACT in epithelial skin cancer and its premalignant stage.~   "
130617|NCT01345747|"~     This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV),~     end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the~     insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective~     gynecological laparoscopic surgery.~   "
130618|NCT01345734|"~     This trial is conducted in Asia. The aim of this trial is to investigate the safety profile~     of liraglutide under normal conditions of use.~   "
130619|NCT01345721|"~     The primary purpose of this study is to evaluate the persistence of bactericidal antibodies~     in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study~     who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This~     is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥~     1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the~     response one month post an additional dose of Novartis MenACWY will be measured by~     percentage of subjects with hSBA titers ≥ 1:8 and GMTs.~   "
130620|NCT01345708|"~     The aim of this prospective study was to evaluate the activity, safety and the duration of~     the response of low dose rituximab associated with standard oral prednisone as first line~     therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease,~     and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral~     prednisone. Further aim was to correlate the clinical response to biological parameters~     (cytokine and anti-erythrocyte antibody production in cultures).~   "
130621|NCT01345695|"~     This study will conduct an evaluation of the World Health Partners (WHP) private provider~     project to see if the social franchising and telemedicine project has an impact on health~     outcomes in treatment vs. control areas. The evaluation will also estimate specific~     parameters of the WHP program that can be used to maximize financial sustainability and~     replicability/scalability of the program.~   "
130622|NCT01345682|"~     This randomised, open-label, phase III study will be performed in patients with R/M head and~     neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The~     objectives of the trial are to compare the efficacy and safety of afatinib versus~     methotrexate~   "
130623|NCT01345669|"~     This randomised, double-blind phase III trial will be performed in patients with head and~     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the~     efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who~     have received definitive chemo-radiotherapy.~   "
130624|NCT01345656|"~     A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and~     randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally~   "
130625|NCT01345643|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 7~10g/dL is based on the judgment from anesthesiologists or~     surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/dL and~     10g/dL is necessary and important in clinical practice. Based on the aim of blood~     transfusion that maintain the balance of oxygen supply and oxygen consumption, the~     investigators hypothesize that index of transfusion trigger for patients with hemoglobin~     level between 7/dL and 10g/dL could be calculated by their history about heart and blood~     pressure, and routine monitoring parameters including pulse oximetry, temperature, and the~     use of vasoactive medications. To verify this hypothesis, the investigators present West~     China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to~     the patient's history and monitoring parameters, and the investigators design a randomized~     controlled clinical trial to test this score.~   "
132225|NCT01324466|"~     The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects~     with recurrent herpes labialis (RHL).~   "
130626|NCT01345630|"~     The purpose of this study is to assess whether maraviroc administered once daily is~     non-inferior to emtricitabine/tenofovir also administered once daily each in combination~     with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at~     Week 48 of treatment.~   "
130627|NCT01345617|"~     The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat~     chloride results that are equivalent to the results from traditional sweat testing. The~     secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum~     Sweat Test compared to traditional sweat testing.~   "
130628|NCT01345604|"~     his study is being done because total knee replacements can leave patients with considerable~     pain after surgery. Therefore, many studies have been done to find the best ways to control~     knee pain after the surgery. Currently, a popular approach is to use many different~     techniques to control the pain. This includes injecting freezing (local anesthetic) into the~     spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and~     using various kinds of medications (e.g. narcotics and anti-inflammatory medications).~     Studies have shown using this a combination of techniques can reduce pain and allow earlier~     discharge from the hospital. However, one downside to this approach is it does not usually~     control the pain in the back of the knee. One new technique has been used to try and~     overcome this. This technique is called a posterior cruciate ligament block or PCL~     block. It involves injecting a drug into the back of the knee which will block the nerves~     in this area. Sometimes the investigators refer to this as freezing.~      The purpose of our study is to determine whether this PCL Block will improve pain after~     the total knee replacement surgery. The investigators will also determine whether this~     technique will improve movement in the knee and lessen narcotic usage after the surgery.~   "
130629|NCT01345591|"~     Injuries resulting in facial trauma are common, and can have devastating consequences on~     your quality of life. While the facial bones can often be reconstructed, physicians strive~     to find better ways to accurately restore injured facial features.~      In this clinical trial funded by the Department of Defense, the investigators are evaluating~     how effectively fat grafting can restore facial features, and how the filling effect of the~     fat graft lasts over time in participants with visible facial injuries. All procedures for~     this research study will be performed at the University of Pittsburgh Medical Center.~   "
130630|NCT01345578|"~     The purpose of this research study is to determine whether partial irradiation of the liver~     and liver cell transplantation can provide help for patients with life-threatening~     liver-based metabolic diseases who are unlikely to survive without extensive medical therapy~     or transplant. The goal of this research study is to determine if liver cell transplants can~     be effective as an alternative to organ transplantation. At the present time, liver cell~     transplants are experimental and have been done in a limited number of human subjects.~   "
130631|NCT01345565|"~     The purpose of this research study is to determine whether liver cell transplantation can~     provide help for patients with liver failure who are unlikely to survive without some form~     of liver support. The goal of this research study is to determine if liver cell transplants~     can be effective until a liver transplant is received or until patients recover from their~     liver failure.~   "
130632|NCT01345552|"~     The purpose of this study is to evaluate feasibility of stereotactic body radiation (SRS) in~     patients with recurrent oligometastatic disease.~   "
130633|NCT01345539|"~     The purpose of this study is to evaluate feasibility of radiosurgery for all metastatic~     sites for patients presenting with oligometastatic disease.~   "
130634|NCT01345526|"~     The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to~     evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to~     doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients~     receiving first line cetuximab treatment.~   "
130635|NCT01345513|"~     This research is being done to find out what types of gene mutations are present in people~     with cancer. This study is designed to help researchers and doctors understand more about~     cancer. With this information, doctors may have a better idea as to which cancer treatments~     are most appropriate for certain patients. The information will also help researchers find~     out the how to identify genes in cancers from biopsies and blood samples and how to use this~     information to help doctors and patients make treatment decisions.~   "
130636|NCT01345500|"~     The purpose of the Take Charge Study is to determine among overweight and obese men and~     women with type 2 diabetes whether 1) participating in a commercial weight loss program~     promotes great weight loss and weight loss maintenance at one year compared to usual care~     conditions and 2) whether there is a differential weight loss response to different dietary~     macronutrient composition (lower carbohydrate/higher fat diet versus a higher~     carbohydrate/lower fat).~   "
130637|NCT01345487|"~     New Nordic diet guidelines advocate a reduction in consumption of protein from animal~     sources such as beef and pork, due to environmental concerns. Instead, intake of protein~     from vegetable sources such as legumes and pulses should be increased. However, little is~     known about the effect of protein from (Nordic grown) beans and peas on body weight and~     appetite regulation.~      The objective of this study is to examine if protein from vegetable sources (beans and peas)~     is comparable to protein from animal sources regarding acute meal-induced satiety.~   "
130638|NCT01345474|"~     This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical~     trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus.~     The goal of the study is to develop a safe, oral pharmacological agent to augment physical~     hearing protectors for noise exposures that exceed the protective capabilities of ear plugs~     and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees~     during and 22 days after their 11 day weapons training. The primary objective of this study~     is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a~     minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.~   "
130651|NCT01345305|"~     This is a study of 40 individuals with Sturge-Weber Syndrome (SWS) brain and/or eye~     involvement. It will examine the test-retest reliability of the following clinical tests:~        1. Quantitative EEG~        2. Transcranial Doppler~        3. Medical Rehabilitation Scales~        4. Optical Coherence Tomography~   "
130639|NCT01345461|"~     As the critical care practice has improved over the last decades more patients are~     recovering from intensive care therapy. However, muscle atrophy and neuromuscular~     dysfunction are commonly observed sequelae after critical illness and are thought to play~     important roles in the development of intensive care unit acquired weakness (ICUAW). As a~     consequence, these entities may contribute to the impaired physical function and prolonged~     convalescence reported by ICU patients up to twelve months after discharge. Thus, strategies~     to counteract muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may~     therefore potentially improve physical outcome and reduce the overall burden of critical~     illness. Limited information is available on muscle function in ICU patients and to our~     knowledge no muscle stimulation methods are currently available for evaluating muscle~     fatigue in large, proximal muscles groups, such as m. quadriceps, in non-cooperating ICU~     patients.~   "
130640|NCT01345448|"~     The purpose of this study is to evaluate the safety and effectiveness in lowering~     intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that~     is applied to the outside of one eyelid.~   "
130641|NCT01345435|"~     A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin~     A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2~     diabetes.~   "
130642|NCT01345422|"~     Patients with dizziness presently undergo physical therapy rehabilitation. Our study will~     study whether Wii Balance Board made by Nintendo Inc. will be helpful in patients with~     dizziness. They will undergo dizziness evaluation to quantify their dizziness.~   "
130643|NCT01345409|"~     Recent research examines many types of complementary and alternative (CAM) therapies.~     However, real-world use of CAM has been largely overlooked.~      This project consists of four discrete sets of project activities (that largely follow one~     another chronologically).~      Phase1 uses information from the EMR (patient electronic medical records) to identify unique~     clusters of patients with CMP (chronic musculoskeletal pain), their care within the health~     plan, and to examine how those in unique clusters may have different uses for A/C~     (acupuncture and chiropractic) services and/or differential outcomes associated with such~     care.~      Phase 2 will conduct a survey of CMP patients from KPNW (Kaiser Permanente Northwest region)~     to establish a broad sample of patients and their use of out-of-plan CAM services.~      Phase 3 will collect qualitative data (focus groups and individual interviews) from KP~     members, KP providers, and acupuncturists and chiropractors from the community to examine KP~     providers' decision to recommend A/C services, A/C services delivered to KP patients, and~     patients' decisions to pursue and retain CAM care. A secondary purpose is to have KP members~     with CMP review planned assessment instruments to improve understandability of the~     instruments. They will provide feedback on: relevancy, any notable omissions of domains~     important in patients' decision to use CAM services for pain treatment. They will also~     provide insight to broader health and quality of life outcomes associated with such CAM~     treatments.~      Phase 4 is a prospective cohort study to evaluate health services/costs and broader clinical~     and functional outcomes associated with the receipt of A/C relative to carefully matched~     comparison participants receiving traditional CMP services.~   "
130644|NCT01345396|"~     Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the~     level of asthma control can decrease during the pregnancy, especially between the 29th and~     the 36th week. The occurrence of such complications are linked with a high asthma severity~     level just before the conception and an history of respiratory complications in a previous~     pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be~     included in an educational progamme. However, this is poorly studied. The purpose of this~     study is to observe if an educational programme given before the 20th weeks of gestation has~     an effect on asthma control until the end of gestation.~   "
130645|NCT01345383|"~     The purpose of this study is to study the impact of smoking in the preceding hours before a~     bronchoscopy on the tolerance of this exam.~   "
130646|NCT01345370|"~     Treatment for newly diagnosed glioblastomas currently involves surgical resection followed~     by Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of~     Temozolomide in adjuvant. According to many studies, only those patients not expressing the~     enzyme repair MGMT benefit from the adjunction of Temozolomide. Therefore, many patients~     receive unnecessary treatment. The aim of this project is to compare different techniques~     for analysis of MGMT in order to choose the approach with the best cost/utility ratio, which~     will allow the selection of patients likely to respond to TMZ chemotherapy during the first~     course of GBM treatment.~   "
130647|NCT01345357|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid~     tumors or mantle cell lymphoma.~   "
130648|NCT01345344|"~     This study design has two components: 1) a cross sectional assessment of brain connectivity~     and response to pain in healthy controls and demographically matched fibromyalgia patients,~     and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to~     either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.~      The investigators will evaluate 90 fibromyalgia patients who will receive CBT treatment once~     a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be~     compared to results from 30 pain-free controls and 60 education program controls.~      Participants will undergo experimental pain assessments as well as brain neuroimaging.~   "
130649|NCT01345331|"~     The Brigham and Women's Pain Management Center is conducting a research study for chronic~     pelvic pain patients due to endometriosis. The study will assess the effect of~     electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you~     have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not~     taking opioid medication (such as morphine or oxycodone). The study will require two visits,~     each lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management~     Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or~     ccahalan1@partners.org if interested.~   "
130650|NCT01345318|"~     This is a multi-center Phase 2, open label, safety extension study in subjects with moderate~     to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will~     have completed the 12-week induction period of study B0151003 and will be enrolled as either~     responders or non responders.~   "
130652|NCT01345292|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks.~      During the first 2 weeks, you will just brush your teeth two times a day with the fluoride~     toothpaste provided.~      Then you will be assigned to a group if you qualify to continue in the study. All groups~     will get a marketed toothpaste and one group will also get a mouthwash with an experimental~     ingredient. You will have an equal chance of being assigned to any one of the three groups.~      For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your~     assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth,~     teeth, tongue and gums and check for sensitive teeth. The investigators will see if the~     mouthwash helps to reduce tooth sensitivity during the study.~   "
130653|NCT01345279|"~     Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit~     comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via~     the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in~     patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were~     some differences between the respective study populations. Patients with prior chemotherapy~     were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used~     for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser~     in GOG-0169 (27%) than in GOG-0179 (~60%) and these patients were unevenly distributed~     between treatment arms in GOG-0169. In addition, the proportion of patients receiving~     cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are~     limitations associated with the indirect meta-analysis.~   "
130654|NCT01345266|"~     This is a clinical study, with no investigational product, to characterise the inhalation~     profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and~     volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD),~     through the novel dry powder inhaler.~   "
130655|NCT01345253|"~     The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to~     standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus~     erythematosus (SLE) over a 52 week period.~   "
130656|NCT01345240|"~     This study has been designed to support the indication of the candidate vaccine (also~     referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when~     administered as a primary vaccination integrated into an Expanded Program on Immunization~     (EPI) regimen to infants living in sub-Saharan Africa.~   "
130657|NCT01345227|"~     The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for~     islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a~     better site than liver thanks to its potential capacity to favor islet engraftment in face~     of a more easiness of access and bioptic follow up.~   "
130658|NCT01345214|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-7746~     across multiple doses in patients with solid tumors and chemotherapy induced~     thrombocytopenia (CIT) scheduled to receive at least two cycles of myelosuppressive~     chemotherapy on Day 1 every 21 days at the same dosages and schedule in the study. The~     secondary objectives are to characterize the PK profiles of ONO-7746 and to explore the~     pharmacodynamic effect of ONO-7746 on CIT.~   "
130659|NCT01345201|"~     This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid~     tumor for which there is no remaining standard curative therapy and no therapy with a~     demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.~     Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and~     efficacy. No formal interim analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned~     dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If~     there is no evidence of disease progression or if the tumor is smaller, then subjects may~     continue to receive IV infusions of OMP-18R5 every week until disease progression.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose~     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled~     in a cohort will not be treated on the same day. The dose may be administered at any time~     during the day. Three subjects will be treated at each dose level if no dose-limiting~     toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will~     be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will~     be dosed at that level and 3 additional subjects will be added to the preceding dose cohort~     unless 6 subjects have already been treated at that dose level. Subjects will be assessed~     for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled~     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day~     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to~     continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14~     subjects will be enrolled at the highest dose level that result in < 2 of the 6 subjects~     experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours)~     or 4 adverse event (DLT).~   "
130660|NCT01345188|"~     Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and~     shortness of breath despite conventional medical therapy and/or revascularization. The~     purpose of this study is to determine the efficacy of taking Ranexa versus placebo in~     patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional~     medical therapy and/or percutaneous revascularization.~   "
130661|NCT01345175|"~     The most common long-term problems after rectal surgery are bowel problems. These problems~     can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully~     clear your bowels, and/or poor control of gas and stool. The investigators believe that a~     major cause of these problems is too much bacteria in the bowel and treatment with~     antibiotic tablets will hopefully help improve these bowel problems. In order to test this~     idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring~     a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless~     tablet that has no effect) in the treatment of these bowel problems. Following this we will~     attempt to see if another antibiotic metronidazole also helps to treat these bowel problems.~     Both Metronidazole and rifaximin are well established drugs that have minimal side effects.~   "
130662|NCT01345162|"~     The aim of the study is the assessment and management of Acute Post-herniotomy Pain using~     two different therapeutical protocols per os: ketorolac versus association of~     acetaminophene+tramadol.~   "
130663|NCT01345149|"~     Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal~     weight gain, the incidence of pregnancy complications and minimize the number of macrosomic~     infants.~   "
130664|NCT01345136|"~     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth~     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives~     include determining if RAD001 treatment will improve hearing ability in NF2 patients.~      RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other~     types of tumors, it is not approved by the FDA for treatment of NF2 related tumors.~   "
130665|NCT01345123|"~     The purpose of this study is to compare condition oriented whole person Health Coaching~     along with the provision of decision aids to decision aids without condition oriented Health~     Coaching to neither condition oriented health coaching nor decision aids on medical cost,~     preference sensitive surgeries and measures of subject knowledge, decision process and~     decision quality.~   "
130666|NCT01345110|"~     Longitudinal observational study of cognitive functions, physical health and biological~     parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773~     subjects, followed for six years in order to know the prevalence and the incidence of~     dementia and risk and protective factors of normal and pathological mental aging.~      The peculiarities of this study that must assure the outcome efficacy are:~        -  Selected age: since 70-75 years old people represents a transition age from adulthood~          to old age, it is of special interest to study the evolution of psychic and physical~          functions of this population~        -  Whole population not a sample study~        -  Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can~          contribute to guarantee more homogeneity among the subjects and reduce undesired~          variability~        -  multidimensional assessment(biological, clinical, social, psychological data collected)~          After initial screening, the recruited population will be followed up for two more~          times (every two years )~   "
130667|NCT01345097|"~     The investigators determined whether~        1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major~          functional improvements~        2. radiographically secure implant fixation is achieved with this new stem~        3. the bone content is preserved at the baseline level or above at the final follow-up~        4. these procedures are associated with early failure and complications.~   "
130668|NCT01345084|"~     Primary: to compare the overall survival defined as the time elapsed between the~     randomization date and death due to any cause, in both treatment groups.~      Secondary: to compare the progression-free survival, incidence of locoregional failure, site~     of the first recurrence/progression, objective response rate assessment, quality of life~     assessment and incidence of adverse events.~   "
130669|NCT01345071|"~     The first objective of the study is to evaluate a treat to target treatment strategy in~     women with moderate to high disease activity of RA and a pregnancy wish, from pre-pregnancy.~     The treatment strategy is based on deliberate treatment decisions to lower disease activity,~     including the continuation or start of biological treatment (in particular anti-Tumor~     Necrosis Factor [anti-TNF]), based on a standard care protocol in the Erasmus MC. The second~     objective is to evaluate the safety of the use of anti-TNF during pregnancy among women with~     a rheumatic disease that require the use of anti-TNF before or during pregnancy.~   "
130670|NCT01345058|"~     This is a study to determine whether a combination of low dose lacosamide and levetiracetam~     is more effective than high dose levetiracetam in patients who have failed low dose~     levetiracetam.~   "
130671|NCT01345045|"~     People with diabetes can, over time develop nerve damage throughout the body with symptoms~     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.~   "
130672|NCT01345032|"~     The purpose of this study is to test two different interventions of nutrition follow up~     after discharge from geriatric ward in undernourished geriatric patients. The patients are~     randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in~     the home visit arm and their home care helper will get visits from a clinical dietician at~     one week, two weeks and four weeks after discharge, in order to follow up on the nutrition~     intervention. Patients in the telephone consultation arm and their home care helper will be~     contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in~     order to follow up on the nutrition intervention. The control arm will not be contacted.~      The primarily outcome is functional ability. Secondary outcomes are quality of life,~     readmission and mortality.~   "
130673|NCT01345019|"~     The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in~     the treatment of bone disease from multiple myeloma.~   "
130674|NCT01345006|"~     This is a safety and tolerability trial to evaluate the effect of subretinal injection of~     human embryonic stem cell derived retinal pigment epithelium cells in patients with~     Stargardt's Macular Dystrophy (SMD).~   "
130675|NCT01344993|"~     This is a safety and tolerability trial to evaluate the effect of subretinal injection of~     human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age~     Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential~     efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular~     therapy.~   "
130676|NCT01344980|"~     The investigators are comparing the combination of a stainless steel repair and aggressive~     early active range of motion rehabilitation protocol for flexor tendon lacerations in the~     hand with a current, accepted treatment offered at our institution. Outcomes to be assessed~     will be time to return to work, joint range of motion in the injured fingers, and any~     potential complications that may arise (ex: surgical infections or repair rupture). All~     proposed treatments included in this study are currently being offered at our institution,~     but not in a randomized fashion.~   "
130677|NCT01344967|"~     Bone is the most common site of spread of breast cancer and bone metastases will occur in~     roughly 70% of women with advanced disease. These patients are at risk of developing bone~     complications that cause significant impact on both patient morbidity and mortality. Close~     to two-thirds of women with bone metastases will go on to develop at least one of these~     complications, termed a skeletal related event (SRE), defined as 1) pathological fractures,~     2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4)~     hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have~     some degree of pain associated with their disease. Understandably these factors negatively~     impact their quality of life. Furthermore, the development of an SRE in this population has~     been shown to be associated with shorter overall survival. Prevention or delay in onset of~     these complications is therefore an important therapeutic goal.~   "
130678|NCT01344954|"~     The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402~     administered as a single intravenous infusion for the prevention of VTE in subjects~     undergoing total hip replacement surgery.~   "
132769|NCT01317329|"~     The purpose of this study is to determine the factors that are associated with improved~     cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to~     severe obstructive sleep apnea.~   "
130680|NCT01344928|"~     The objectives of this study are to investigate the effects of short-time high-intensity~     interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2~     diabetic patients using modern and noninvasive imaging methods positron emission tomography~     (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).~   "
130681|NCT01344915|"~     Knee immobilization in near extension has been proposed as a nonoperative treatment for~     primary traumatic patellar dislocation, although there exist no prospective studies~     regarding the method of immobilization. The objective of this prospective randomized study~     was to compare the clinical outcome after nonoperative treatment with restricted vs. free~     range of motion (ROM) for primary traumatic patellar dislocation.~   "
130682|NCT01344902|"~     The purpose of the study is to determine if it is possible to detect more pre-cancerous~     lesions in colon when using fluorescence technology.~   "
130683|NCT01344889|"~     This observational study will assess factors leading to dose reductions/treatment~     discontinuations and the effect on sustained virological response in patients with chronic~     hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and~     ribavirin. Data will be collected from each patient for the duration of their treatment and~     for up to 6 months thereafter.~   "
130684|NCT01344876|"~     To determine the maximum tolerated dose (MTD) of OPB-51602~   "
130685|NCT01344863|"~     This randomized, open-label, parallel, 2-arm, multicenter study will compare the~     administration of Herceptin (trastuzumab) with a single-use injection device versus a~     handheld syringe in healthy male volunteers. The volunteers will receive a single dose of~     600 mg Herceptin. The anticipated time of the study is 21 weeks.~   "
130686|NCT01344837|"~     This research study is studying biomarkers in blood and tissue samples from patients with~     uterine cancer. Studying samples of blood and tissue from patients with cancer in the~     laboratory may help doctors learn more about changes the occur in DNA and identify~     biomarkers related to cancer.~   "
130687|NCT01344824|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may~     also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.~     Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor~     cells.~      PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium~     together with bevacizumab works in treating patients with stage III or stage IV non-small~     cell lung cancer who are light or never smokers.~   "
130688|NCT01344811|"~     A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart~     Care Service in obese patients with metabolic syndrome.~   "
130689|NCT01344798|"~     The purpose of this trial is to study the evaluation of clinical safety and feasibility of~     gene therapy in patients with limb girdle muscular dystrophy type 2C~     (gamma-sarcoglycanopathy).~   "
130690|NCT01344785|"~     The purpose of this study is determine the relationship between pain and protrusion of the~     implant after surgery for a intertrochanteric fracture.~   "
130691|NCT01344772|"~     The primary aim of this study was to determine the Harris hip score as an evaluation of hip~     function, in mentally competent elderly patients (>65 years old) treated with either THR or~     IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare~     the rate of reoperations and complications between the two groups.~   "
130692|NCT01344759|"~     The purpose of this research study is to examine the effects of two commonly used anesthetic~     drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway~     in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA)~     having an MRI scan.~      The results of this study will help in making the best decisions regarding the anesthesia~     medications that are most appropriate for children, adolescents, and young adults with OSA~     during MRI studies.~   "
130693|NCT01344746|"~     Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is~     involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a~     theoretical evidence for LTs modify therapy in treating pediatric patients with SDB.~      The investigators have hypothesized that the pathophysiology of pediatric SDB involves~     specific systemic and local upper airway inflammatory response mediated by LTs.~        1. LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4)~          and cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in~          comparison to healthy ones, and LTs productions emerge disease severity-dependent~          increases.~           There is a positive correlation between LTs production and other systemic markers such~          as neutrophil counts and high sensitive C-reactive protein (hsCRP).~        2. Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2~          (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent~          infectious tonsillitis subjects.~        3. Levels of LTs are positively correlated with body mass index (BMI) z-score, waist~          height ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including~          apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index~          (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and~          negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which~          indicates synergistic role of obesity and hypoxia are the determinants of LTs~          production in SDB.~        4. In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular~          proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor~          antagonists (LTRAs) elicit dose-dependent cellular reductions.~   "
130694|NCT01344733|"~     The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of~     HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the~     study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients~     matching inclusion and exclusion criteria will be enrolled consecutively; each investigator~     will include the first 10 to 40 patients that will be visited as treatment resistant MDD.~   "
130695|NCT01344720|"~     This randomized, single-blind, parallel-group study will investigate the efficacy and the~     tolerability of a combination treatment of etoricoxib (30 mg/day) plus controlled-release~     oxycodone (10 mg/day) compared with a titrated dose of etoricoxib up to 60mg/day as~     monotherapy , in patients with Chronic Low Back Pain (CLBP) who have not responded to the~     starting dose of Etoricoxib 30mg/day. A common clinical question is that is it better to~     increase the dose of the current monotherapy or to combine both treatments early on, in~     patients who do not respond to standard start doses of NSAIDs like etoricoxib.~   "
130698|NCT01344681|"~     This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic~     refractory fever. The investigators evaluate efficacy and safety of micafungin sodium~     (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a~     control and this study is prospective, randomized, non-inferiority trials.~      Therefore, this study was planned for review of the safety and efficacy in korean patients.~   "
130699|NCT01344668|"~     The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids,~     weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24~     months follow-up.~   "
130700|NCT01344655|"~     This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small~     airways physiological parameters in COPD patients.~   "
130701|NCT01344642|"~     The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA~     in saliva.~   "
130702|NCT01344629|"~     To investigate the bioequivalence of telmisartan administrated in two different ways: both~     in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan~     80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use~   "
130703|NCT01344616|"~     Timely screening and management of modifiable conditions can reduce preterm births, yet~     providing effective prenatal risk management systems to meet the unique needs of medically~     underserved populations is complex. If the proposed system proves to be effective in~     reducing preterm births it can improve maternal and child quality of life as well as reduce~     the economic burden of preterm births in the U.S.~   "
130704|NCT01343641|"~     This year-long investigator-initiated study is designed to determine effects of MK-0677, a~     GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing~     the following procedures: Informed consent process, followed by evaluation and screening~     tests to confirm patients' eligibility. Patients whose screening laboratory results for~     glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility~     criteria will not be randomized. Other exclusions are Congestive Heart Failure Class III or~     IV by the New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular~     disorders within six months of baseline visit and muscle weakness associated with~     neuromuscular or neurological disorders. Before the subject begins taking the experimental~     drug MK-0677 or placebo, baseline assessments of subjects' hormone and cytokine levels,~     physical condition, body mass (determined by a DEXA scan), strength and functionality, and~     appetite will be obtained. In addition, quality of life assessments (SF-36) will be~     administered. This study's primary outcome is an increase in lean body weight. Secondary~     outcomes are cytokine and hormone levels, including, leptin, insulin, ghrelin, TNF- alpha,~     CRPs, IL-1, IL-6, and IL-10, ghrelin associated esterase and adiponectin, nutritional~     status, quality of life (QoL), food appreciation, physical function and economic impact. 70~     subjects will be the enrollment target. This number was determined to offset projected~     screen failure and early withdrawal rates, and to ensure that 42 subjects complete the~     study.~   "
130705|NCT01343628|"~     Alcohol dependence, or alcoholism, affects approximately 14 million Americans. Currently,~     only three pharmacotherapies (disulfiram, naltrexone, and acamprosate) have been approved~     for the treatment of alcohol dependence and these medications are, at best, moderately~     successful. Thus, there is a great need for the examination of other biological systems,~     which contribute/influence the drug reward/addiction pathways within the brain, such that~     the discovery of new targets and new pharmacotherapies will be possible. Other biological~     systems in addition to dopamine, such as serotonin, and norepinephrine (NE) are thought to~     be important in several aspects of addiction, including reward, craving and depression.~      This study will examine the effects of a 5 day course of atomoxetine (a selective NE~     transporter (NET) inhibitor) (80 mg/day; Strattera or placebo) on alcohol-elicited craving~     and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact~     that it targets NET, neither of which has heretofore been examined in the context of alcohol~     dependence. It is hopeful that this study, of 64 total individuals, will provide the PI with~     sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and~     the involvement of specific single nucleotide polymorphisms within the NET gene on~     alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term~     objective of this research is to develop more efficacious treatment interventions for~     alcohol abuse and dependence.~   "
130706|NCT01343615|"~     The purpose of this study is to determine the clinical and radiologic implications of the~     intraoperative microemboli during carotid revascularization.~   "
130707|NCT01343602|"~     The aim of this study is to evaluate the efficacy of a modified approach of constraint~     induced movement therapy (CIMT at home) for chronic stroke patients, compared to~     conventional physiotherapy and occupational therapy (therapy as usual) with regard to the~     ability to participate in everyday activities.~   "
130708|NCT01343589|"~     To investigate the effect of milk delivered from mountain-pasture grazing cows on risk~     markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish~     milk. The study should reveal the importance of phytanic acid content for these effects.~   "
130709|NCT01343576|"~     The aim of the study is to investigate if cow feeding regimes affects concentration of~     plasma phytanic acid and risk markers of the metabolic syndrome in human.~   "
130710|NCT01343563|"~     This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an~     adjunctive treatment for adults with major depressive disorder (MDD) when added onto~     antidepressant medications. Our primary objective is the examination of two different~     doses of TNS, in terms of pulse frequency.~      To accomplish our specific aims, the investigators will test the following specific~     hypotheses:~        1. Subjects will show greater improvement in ratings of mood and other symptoms of~          depression during the six-week of high frequency stimulation than during low frequency~          stimulation periods.~        2. Subjects will show greater improvement after 12 weeks of high frequency stimulation~          than after six weeks of high frequency stimulation.~        3. Subjects will show improvement in ratings of life functional capacity and quality of~          life with TNS.~        4. Subjects will report the TNS treatments to be acceptable in terms of side effects and~          burden of using the device.~        5. Subjects will show significant differences in regional brain function at the end of the~          high frequency stimulation period compared with baseline, and significant differences~          between high and low frequency stimulation conditions.~   "
130713|NCT01343524|"~     The investigators' Upstate Cystic fibrosis (CF) Care Center is very active in research. For~     example, in 2009, 68 of our 135 pediatric patients have been participating in 16 clinical~     trials. Sponsors often provide their study sites with spirometers to use for PFTs. These~     machines are meant to provide uniform PFTs results for studies, which include measurement of~     FEV1 values. In 2009, among the 52 patients at our Center who are 6-12 years old, 20 (38%)~     have been in studies with sponsor-provided spirometers. Among the 32 patients ages 13-17~     years, 13 (40%) have been in studies with sponsor-provided spirometers. Anecdotally, the~     investigators have noted that FEV1 results obtained during clinical trials for our patients~     appear to be lower than those of our patients' usual values, especially with younger~     children. The investigators hypothesize that the apparent difference in PFT results might be~     related to the different incentives (if any) provided by study PFT equipment. Further, if~     this difference exists, the investigators believe that this may account for the apparent~     average decline in the lung function results of our patients over the recent years, given~     the large proportion of our patients who participate in clinical trials. Finally, the~     investigators hypothesize that younger children may be more affected by the difference in~     incentives than older ones.~      The purpose of this study is to collect an additional set of Pulmonary Function Tests (PFTs)~     using our regular clinic equipment, on all study subjects following their study PFTs if~     these are done with sponsor-provided equipment. The investigators will compare the results~     from both types of machines and report regarding differences identified.~   "
130714|NCT01343511|"~     Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by~     social interaction abnormalities, impaired verbal and non-verbal communication, and~     repetitive, obsessive behavior, while the therapeutic effect of current treatments remains~     limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies~     associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human~     cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the~     immune response and enhance angiogenesis, suggesting the novel and promising therapeutic~     strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation~     will be evaluated in patients with Autism.~   "
130715|NCT01343498|"~     This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of~     BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation~     given twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of~     the twice daily dosing. Patients will initially be given once daily dosing to determine the~     PK and PD of the single daily dose. On Day 9, they will begin twice daily dosing, with half~     of the single daily dose divided twice daily, and PK and PD of the twice daily dose will be~     determined.~   "
130716|NCT01343485|"~     Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a~     prospective, cluster randomized trial to determine which factors influence the acquisition~     of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19~     to 26. This descriptive and interventional study will provide data to assess impact of a~     computerized tool upon HPV vaccine series completion. The interventional aspect of this~     study includes determination of patient assistance and provider support programs applicable~     to each woman's situation as well as the implementation of a computer software system for~     customized patient reminders.~   "
130717|NCT01343472|"~     This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The~     purpose of the evaluation is to test whether subjects assigned to WISP perform better than~     those assigned to parole-as-usual (PAU).~   "
130718|NCT01343459|"~     Title:~      HIOB - Hypofractionated Whole-Breast Irradiation preceded by Intraoperative Radiotherapy~     with Electrons as anticipated Boost ISIORT- 01~      HIOB is defined as hypofractionated WBRT (40,5 Gy in 2,7 Gy per fraction) preceded by an~     Intraoperative Boost to the tumor bed ( 90 % reference dose of 10 Gy, 11,1 Gy Dmax IOERT).~      Primary endpoint is the proof of superiority of a new treatment regimen.~      The HIOB study concept is supposed to test the hypothesis whether such a combined schedule~     is superior (or iso-effective) towards standard RT in terms of local control and cosmetic~     outcome.~      In the vast majority of all publications, annual and 5 year in-breast recurrence rates~     following BCT showed a clear dependency on patient age within the following boundaries~     (primary references):~      Age > 50: Bartelink (standard): 0,7% (annual) 3,5% (5y) START B (best): 0,4 %(annual) 2,0%~     (5y)~      Age 41-50: Bartelink (standard) 1,2% (annual) 6,0% (5y) Whelan (best) 0,72%(annual) 3,6%~     (5y)~      Age ≥ 35-40 Bartelink (standard) 2% (annual) 10% (5y) Whelan (best) 0,72% (annual) 3,6% (5y)~      long these three different age groups, benchmarking will be performed against the best~     published results following `Golden Standard`RT, usually defined as conventionally~     fractionated WBRT with 50 Gy (25 x2) plus external tumor bed boost with 10-16 Gy electrons~     (5-8x2Gy).~      Superiority is defined as going below the lower limit of the estimated 5 year local~     recurrence rate within the respective age group Inferiority is defined as crossing the~     respective upper limit .~      Secondary endpoint:~      Disease free survival~      Tertiary endpoint: toxicity assessment (acute and late) including long term cosmetic~     evaluation~      Study design and statistics:~        -  Prospective multicenter single-armed~        -  Sequential probability ratio test (SPRT)~        -  Separate analysis within three different age groups~      Estimated Accrual time: strongly dependent on recruitment per year within the respective age~     group . Due to the statistical estimation of Szenario A and B the study will close after~     max. Time-period of 10 years in case of A or 6,4 years in case of B..~      Principal investigators and study coordinators:~      UC of Radiotherapy and Radio-Oncology UC of Special Gynecology and Breast Cancer Center~     Landeskrankenhaus Salzburg, Paracelsus University Clinics~   "
130719|NCT01343446|"~     To examine the effect of sleep impairment on coping style of patients with diabetes~   "
130720|NCT01343433|"~     Our purpose of this study is to determine whether bright light therapy is effective for~     reducing the incidence and the duration of delirium compared to the usual treatment in~     patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is~     effective for reducing the incidence and duration of delirium in patients at the Intensive~     Care Unit~      Patients will be assigned to a chamber with or without bright light therapy. This assignment~     is based on occupation of ICU beds and availability of nurses and is therefore independent~     from patients characteristics. Patients will be included following the inclusion criterion~     and exclusion criteria. Patients assigned to a chamber with bright light therapy will~     receive light therapy for three hours in the morning, from eight o'clock till eleven~     o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation~     Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses,~     this is according to the existing routine. Besides this, an extra CAM-score and a clinical~     assessment will be performed once a day by a trained non-clinician, to determine the~     presence of delirium. The use of sedatives, haldol and fixation will be registered to~     determine the occurrence, duration and severity of delirium. Eventually the most important~     outcomes will be the clinical assessment of the patients, the CAM-score and the use of~     haldol. The primary outcome of this study is the duration of delirium, defined in number of~     days.~   "
130721|NCT01343420|"~     Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat,~     cockroach, and nuts, and are used to identify allergies by observing the body's reaction to~     the introduction of extract underneath the skin. There are a few dog allergen extracts~     commercially available in the US for allergy testing; however, none of these products are~     standardized, meaning they are not required to be the same strength. Because some extracts~     are not as potent (strong) as others, it's possible that some patients' allergies are~     misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that~     allergic patients are correctly diagnosed.~      The purpose of this study is to compare the safety and potency of an investigational (not~     approved for use by the United States Food and Drug Administration [FDA]) dog allergen~     extract with two commercially available dog extracts, which are of differing potencies.~   "
130722|NCT01344603|"~     In the present study the investigators test the hypothesis that the epidural anesthesia~     added on the general anesthesia is able to improve patient's outcome.~   "
130723|NCT01344590|"~     Vascular access via central venous lines (CVL) is essential to the care of many patients in~     the intensive care setting. While the value of these lines for the management of critically~     ill patients is generally accepted, the potential for line-associated blood stream infection~     is a known complication of the use of this intervention.~      Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human~     pathogens.~      The purpose of this study is to evaluate the effectiveness of daily treatment of the~     catheter lumen with ethanol to prevent central line associated blood stream infections~     (CLABSI). The hypothesis is that this treatment will reduce the incidence of CLABSI compared~     to maintenance of the lines with normal saline alone.~   "
130724|NCT01344577|"~     The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2~     HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation~     technique; (second) to evaluate clinical outcomes of socket preservation procedures~     performed using the Buccal Plate Augmentation technique.~   "
130725|NCT01344564|"~     The purpose of this study is to determine if patients initiating androgen deprivation~     therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide~     acetate after an initial three-month period without a rise in serum testosterone. The~     investigators expect testosterone will quickly and reliably reach castrate levels after~     initiation of ADT and will remain castrate during the transition, and there will be no~     testosterone surge after leuprolide injection.~   "
130726|NCT01344551|"~     To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function~     in healthy older adults.~   "
130727|NCT01344538|"~     The purpose of this study is to determine if ginger root extract when taken daily for 28~     days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut~     tissue of people who are at normal risk and those at increased of developing colorectal~     cancer compared to people taking placebo.~   "
130728|NCT01344525|"~     Obese individuals that undergo major intervention such as a low-calorie formula diet program~     or bariatric surgery with the result of substantial weight loss (> 10%) are included and~     followed-up for at least 3 years. Weight changes and excess weight loss as well as measures~     of quality of life are monitored. In addition, biomaterials will be collected from these~     individuals every 6 months for measurement of parameters related to obesity-associated~     gastrointestinal (GI) impairments such as change in GI hormone levels, change in GI~     microbiota, or enhanced bacterial translocation. Moreover, micronutrient and metabolomics~     analysis will be performed. This project allows comparison of non-surgical and surgical~     intervention and enables to asses the anticipated relationship between obesity and the GI~     tract in humans in the future.~   "
130729|NCT01344512|"~     The Pharm A project is a French national collaborative project aiming to determine the~     population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric~     patients aged one month to five years.~   "
130730|NCT01344499|"~     Measurement of residual peritoneal fluid after laparoscopic surgery~   "
130731|NCT01344486|"~     Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease~     post-operative pain, inflammation and adhesion formation.~      Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain~     and adhesion formation.~   "
130732|NCT01344473|"~     Fixed dental braces are associated with the risk of developing White Spot Lesions (WSLs),~     which appear as white chalky marks on the teeth. They develop as a result of the acid~     produced by bacteria in dental plaque dissolving the outer surface of the tooth, known as~     demineralisation. Recently, amorphous calcium phosphate (ACP) stabilised by casein~     phosphopeptide (CPP) has become available, and it is reported to help rebuild the surface of~     teeth which have WSLs. CPP-ACP is available incorporated into a crème known as Tooth Mousse~     (TM). While there appears to be sufficient evidence regarding the use of CPP-ACP in~     promoting general remineralisation, for the first time this study aims to examine the use of~     CPP-ACP to treat WSLs in post-orthodontic participants.~   "
130733|NCT01344460|"~     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic~     resonance angiography) will be invited to participate in the study and subjects will be~     involved in the study for between 2 and 12 days. Two to three visits to the study doctor~     will be required.~      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA~     images taken without contrast agent using images from a CTA as the standard of reference,~     which may have been performed up to 60 days prior to enrolment. If a CTA has not been~     performed in this prior time period, a CTA is required for the study.~      MRA and CTA images will be collected for an independent review (blinded read).~   "
130734|NCT01344447|"~     Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic~     resonance angiography) will be invited to participate in the study and subjects will be~     involved in the study for between 2 and 12 days. Two to three visits to the study doctor~     will be required.~      This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA~     images taken without contrast agent using images from a CTA as the standard of reference,~     which may have been performed up to 60 days prior to enrolment. If a CTA has not been~     performed in this prior time period, a CTA is required for the study.~      MRA and CTA images will be collected for an independent review (blinded read).~   "
130735|NCT01344434|"~     This study hypothesizes that renal transplantation candidates are diagnosed with significant~     Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive~     modalities. Therefore the investigators are investigating the ability of coronary computed~     tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch~     and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).~   "
130736|NCT01344421|"~     The purpose of this study is to examine the movement pattern in patients with hip dysplasia~     preoperative, six and 12 month after minimally invasive approach for Periacetabular~     osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy~     controls and historical data.~   "
130737|NCT01344408|"~     BACKGROUND A Cochrane review from 2003 found that about 30% of people 65 years or older each~     year fall and that number is even higher for elder people living in institutions. Falls are~     the cause of 95% of all hip fractures, resulting in prolonged hospitalization and prolonged~     disability. In patients who are referred to the emergency room after unexplained fall, a~     study of 564 patients showed that 80% of the patients had vestibular symptoms characterized~     by balance problems, nausea, impairment, vomiting, and dizziness. 41% of the patients had~     dizziness suggesting a dysfunctional vestibular system called vestibular dysfunction. In~     patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk.~     Several studies show however that the elderly has a decreased compliance in relation to the~     performance of home exercise.~      A solution to support the older vestibular rehabilitation process and to maintain the~     achieved level of functionality after the rehabilitation process is the computer-training~     program Move It To Improve It (MITII). Based on individual studies and tests therapists~     develop a personalized rehabilitation program permanently corrected, modified and adjusted.~     The system generates feedback to the therapists at hospital with information about the~     person's daily training and scores of individual exercises. The Web cam makes it possible to~     make video footage and pictures to be used in the feedback information. The system also~     establish direct communication between users and therapists. The web community provide the~     framework for a telerehabilitation system, which means that the hospital can service more~     users in the same period.~      The ph.d. consist of three studies which has the purposes:~      To compare a computer exercise program (Mitii) with conservative home-training according to~     printed instructions in the rehabilitation of patients with vistibular dysfunction in an~     outpatient clinic To investigate whether the effect of vestibular rehabilitation is~     preserved three months after the completion of supervised training in an outpatient clinic~     for specific vestibular rehabilitation and whether a computer assisted home training program~     (Mitii) is superior to printed instructions in this respect To evaluate patient experience~     and barriers for the use fo the computer assisted rehabilitation of patients with vestibular~     dysfunction~   "
130738|NCT01344395|"~     The primary aim of this study is to evaluate if multiple postoperative administrations with~     a solution of ropivacaine, ketorolac and epinephrine into the operating field through a~     catheter would affect morphine consumption. Secondary end-points are pain intensity, side~     effects and length of stay.~   "
130739|NCT01344382|"~     This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and~     Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an~     out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are~     the most commonly available method for helping family members. The investigators will~     compare CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a~     significant difference in adolescent treatment entry. Parents will attend a maximum of 18~     sessions with a family specialist and also complete questionnaires periodically over a~     12-month period. Parents' adolescents will have the opportunity to participate in the study~     by completing questionnaires at the same time points as their parent. Our primary hypothesis~     asks whether participants who are enrolled in the CRAFT-P condition will report more~     adolescent treatment entry than the ANF condition. Our secondary hypotheses examine: 1)~     reductions in adolescent substance use and behavior problems in the CRAFT-P group compared~     to the ANF condition, 2) improvements in parenting skills in the CRAFT-P group compared to~     the ANF condition and 3) significant pre to post treatment effects for improvements in~     social functioning, mood, and in parent-adolescent relationship satisfaction.~   "
130740|NCT01344369|"~     The purpose of this study was to evaluate the relative bioavailability of a test formulation~     of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals,~     USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol~     and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed~     conditions in healthy, non-tobacco using, adult female subjects.~   "
130741|NCT01344356|"~     This study will evaluate the local control rates as well as acute and late toxicity rates of~     stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and~     neck tumors.~   "
130742|NCT01344343|"~     There is preliminary evidence that suggests early surgical treatment of a hip fracture may~     improve patients' outcomes. The investigators propose to do a pilot randomized controlled~     trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair~     (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically~     surgery after 36-48 hours).~   "
130743|NCT01344330|"~     This research study will assess cruciferous vegetable intake in patients presenting for~     screening colonoscopy and correlate intake with histone status and histone deacetylace~     (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs).~     The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker~     of cruciferous vegetable intake.~   "
130744|NCT01344317|"~     Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas~     of prematurity. Both substances have effects on the central nervous system. While there are~     data available concerning the use of caffeine (the methylxanthine used at our NICU) even~     proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are~     data which suggest a negative effect of the central stimulants doxapram on longterm outcome~     in this group of infants. Nevertheless concerning both medications only few studies have~     been published and only scarce data are available concerning the effect of these medications~     on brain activity of very preterm infants until now.~      The aim of this study: is the assessment of the effect of stimulating substances on brain~     activity of preterm infants born below 30 weeks of gestation and their longterm~     neurodevelopmental follow-up.~      Methods: This study is a prospective study including preterm infants born below 30 weeks of~     gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG).~     The first aEEG measurement is performed without caffeine and/or doxapram medication. At~     least one hour of brain activity is registrated. The second measurement is done at least 24~     hours after the start of caffeine and/ or doxapram treatment.~      The percentage of different background patterns, the occurrence and duration of~     sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed.~     Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment~     of the Bayley Scales of Infant Development II and standardized clinical neurological~     examination.~   "
130745|NCT01344304|"~     The object of this study is to evaluate the superiority of aprepitant therapy with a~     5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a~     5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first~     course chemotherapy.~   "
130746|NCT01344291|"~     Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for~     this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50%~     of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these~     drugs. Curcumin is the main derivative of turmeric ,an old spice which is used frequently in~     Indian and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells~     proliferation and also intracellular hormone production. The purpose of this study is to~     evaluate the effect of turmeric on prolactinoma patients.~   "
130747|NCT01344278|"~     The main goal of this study is to examine the comparative effectiveness of diabetes~     prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of~     the following conditions: obesity, hyperglycemia, hypertension and depression. This~     randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern~     California. Women in the intervention will receive a letter on gestational weight gain~     during pregnancy and in the postpartum period, a curriculum of individualized lifestyle~     counseling via telephone, augmented with e-mail and an interactive Web site. Patients~     randomized to the usual care arm will receive the standard-care telephone calls from the~     Perinatal Center during pregnancy and the Center's printed educational materials postpartum.~     Outcomes will be assessed through the electronic medical record and patient surveys~     conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.~   "
130748|NCT01344265|"~     The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be~     correlated with global end diastolic volume (GEDV) as measured by transpulmonary~     thermodilution technique (PiCCO). The rationale is that some animal studies have proven that~     BNP is released from ventricular myocardium in response to physical expansion. Such physical~     expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the~     serum level BNP can be used to monitor volume status of critically ill patient, instead of~     the invasive monitoring system.~   "
130749|NCT01344252|"~     The options for anesthesia in cataract surgery described are: general, regional or local.~     The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar),~     subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar,~     have made subtenon and topical strategies the most used. Likewise, to improve the~     effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose~     of lidocaine.~      Subtenon and topical anesthesia are two safe strategies and there were performed multiple~     studies showing that both are effective in controlling pain, but showing a slight~     superiority of subtenon. This difference does not appear to be clinically significant. In~     turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack~     evidence to compare patient preference when using topical gel and intracameral anesthesia~     versus sub-Tenon anesthesia.~      Multiple advantages has the topical anesthesia. Besides being a safe strategy for the~     patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia~     postoperatively, subconjunctival hemorrhage and chemosis.~      Because of this the investigators plan to conduct a study comparing the efficacy of gel~     topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with~     scleral incision, assessing the patient's preference Hypothesis: Topical administration of~     lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia~     in cataract surgery~   "
130750|NCT01344239|"~     To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects~     against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal~     aortic aneurysm (AAA) repair.~   "
130751|NCT01344226|"~     Investigate the intraocular pressure(pressure inside the eye) of patients who are treated~     with Lotemax after undergoing cataract surgery.~   "
130752|NCT01344213|"~     To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of~     intrathecal morphine for patients after total knee arthroplasty.~   "
130753|NCT01344200|"~     Background: Celecoxib is effective for reducing postoperative pain in adults. Children use~     celecoxib more rapidly than adults and require higher doses. Celecoxib is partially~     metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme~     can influence how well their body uses Celecoxib. Understanding the blood and cerebrospinal~     fluid (CSF) profile of celecoxib in children and the influence of genetics on metabolism~     would help to develop appropriate celecoxib dosing in children for various treatment~     options.~      Objective(s) and Hypothesis: Our primary objective will be to create a pediatric profile of~     celecoxib in the blood and the central nervous system as well as explore the relationship~     between CYP2C9 polymorphisms and documented adverse events~      The investigators hypothesize that the CSF concentrations of Celecoxib post dose are lower~     than plasma levels, take longer to reach peak concentration and are directly related to~     dose, genetics, and age. The investigators expect that Celecoxib will improve quality of~     life and reduce discomfort when administered before and after a lumbar puncture and bone~     marrow aspirate.~      Potential Impact: The results of this study will establish the safety of celecoxib in~     children as well as help us define the best dosing for acute pain. It may also help reduce~     the incidence of acute pain evolving into chronic pain. Finally, it may provide insight into~     celecoxib's future use in chemotherapy.~   "
130754|NCT01344187|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
130763|NCT01344070|"~     Generic formulations of prescription drugs can, through their relatively lower cost, improve~     healthcare as long as they maintain their registration-quality and public trust. On the~     other hand, the market availability of several generic formulations raises a concern~     regarding their interchangeability, despite being proven to be individually therapeutically~     interchangeable with their corresponding innovator formulation.~      The investigators propose to assess the quality and therapeutic interchangeability of~     generic formulations in the drug market of Saudi Arabia, using fifteen, commonly-used, oral,~     solid, immediate-release, and non-combinational drugs.~   "
130755|NCT01344174|"~     This is a randomized, open label study evaluating the efficacy and safety of glucocorticoids~     in patients with HBV associated pre-ACLF.~      Sponsor: Department of infectious diseases, Southwest Hospital.~      Indication: HBV associated acute-on-chronic pre-liver failure(pre-ACLF-HBV).~      Objective: To evaluate the efficacy and safety of glucocorticoids in patients with~     pre-ACLF-HBV.~      Trial Design: Randomized, open label study. Patients with pre-ACLF-HBV will be randomized~     1:1 to One of the two groups:~      A)Dexamethasone 10mg were intravenously injected po daily for the first 5 days, in~     combination with continued lamivudine 100mg po daily and traditional supporting treatments~     for 13 weeks. B)Control group. Any glucocorticoids will be not given in all patients.~     Continued lamivudine 100mg po daily and traditional supporting treatments will be given for~     13 weeks.~      Number of patients: Approximate number of patients to be randomized: N=200 (100 patients in~     each group).~      Length of study: Screening period: 3 days; treatment period: 13 weeks.~      Duration of study: 30 months after first patient randomized, including an recruitment period~     of 26 months.~      Investigational treated regimen:Dexamethasone 10mg, iv, once day for 5 days.~      Concomitant and Comparative regimen: Lamivudine 100mg po daily, traditional supporting~     treatments.~      Assessments of Efficacy Primary endpoint: the survival rate at week 13. Secondary~     endpoint:①The levels of serum T-Bil ≤ 51.3µmol/L;②PTA ＞80%.~      Safety: Adverse events, vital signs, and laboratory tests.~      Procedures(summary): After signing informed consent and meeting screening parameters,~     patients will be randomized to one of the two treatment groups as described under trial~     design above. After randomization patients will be seen for evaluation at days~     5,10,14,21,28,42,56,70,84,91.~      Statistical analysis: Assume 1:1 randomization. The sample size is calculated for the~     primary efficacy variable, the survival rate. Assuming the survival rate equals to: 90% for~     group A and 50% for group B. 100 patients in each group are required to yield a 80% chance~     of detecting such a difference when a two-tailed test is employed at the 0.05 significance~     levels. Every eligible subject will be assigned with a randomization code and receive one of~     the two treatments, according to the sequence of enrolled.~   "
130756|NCT01344161|"~     The investigators investigated the effect of vitamin D3 supplementation on metabolic profile~     (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in~     overweight or obese women.~   "
130757|NCT01344148|"~     To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment~     in individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized~     study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the~     efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated~     8 weeks after initiation of TB treatment.~   "
130758|NCT01344135|"~     To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with~     muscle atrophy:~        1. The short-term effects of 4 months exercise training including nutritional~          supplementation versus exercise training alone on physical functioning (skeletal muscle~          strength and exercise capacity) and body composition.~        2. The long-term effects of 4 months of exercise training and nutritional supplementation~          followed by 8 months of nutritional counseling (with supplementation on advice) and~          feedback on physical activity level versus 4 months of exercise training and 8 months~          with feedback on physical activity level alone on physical functioning, body~          composition and cardiometabolic risk profile;~        3. The cost-effectiveness of exercise rehabilitation and nutritional intervention versus~          exercise rehabilitation alone.~   "
130759|NCT01344122|"~     The goal of this study is to see whether or not a strategic planning process is able to~     introduce and sustain improvements in the working relationship between probation/parole~     departments and community-based addiction treatment agencies that provide medication~     assisted therapy (MAT) for individuals with opioid or alcohol dependence. In addition, this~     study seeks to improve probation/parole agency personnel's knowledge and perceptions about~     MAT, and increase the number of appropriate referrals to community treatment agencies that~     provide MAT. There are three phases to this study. Phase 1 includes a pilot study to~     determine the quality and availability of client level records and the collection of~     baseline data (the pilot study protocol was previously submitted to TMH IRB). Phase 2 will~     consist of a Knowledge, Perceptions and Information (KPI) intervention during which~     probation/parole agencies will undergo training to increase knowledge about the~     effectiveness of MAT, and complete a post training assessment to evaluate the effectiveness~     of the KPI intervention. During Phase 3, probation/parole agencies will be randomly assigned~     to a 12-month Organizational Linkage Intervention (OLI) condition or to control (no further~     intervention). Agencies assigned to the OLI will establish a Pharmacotherapy Exchange~     Council (PEC) that consists of staff from both the probation/parole and community treatment~     agencies. The PEC will undergo a strategic planning process to increase the availability of~     MAT for opiate and/or alcohol dependent individuals who are on probation/parole.~   "
130760|NCT01344109|"~     This is a pilot study evaluating the use of tumor derived exosomes as a marker for response~     to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer.~     Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in~     breast cancer, which could prove to be a tool for earlier diagnosis, more effective~     treatments, and improved markers of response in order to increase survival rates.~   "
130761|NCT01344096|"~     In Gaucher disease type I bleeding is a common presenting symptom, that may manifest itself~     as frequent nose bleeds, easy bruising but can also cause substantial bleeding after~     surgical or dental procedures and may occur in association with pregnancy or delivery . The~     bleeding tendency is usually considered to be secondary to thrombocytopenia However 50,000~     platelets are enough in healthy people to give a normal bleeding time but are associated~     with significant bleeding tendencies in Gaucher patients. Bleeding tendency might be~     attributed by genetic inherited or Gaucher related coagulation factors abnormalities which~     in some cases stabilize with ERT. However, In other cases the etiology is an abnormality of~     platelet function. This thrombocytopathy has not been delineated and apart from a few~     aggregation studies, no systematic analysis has been published that convincingly shows the~     cause of the disturbed function. While, experience shows that enzyme replacement (ERT, i.e:~     imiglucerase, Cerezyme®) reduces this bleeding tendency, in part due to the improvement in~     the thrombocyte count and elevation in coagulation factors, it is less clear what effect ERT~     has on the thrombocytopathy. This has clinical significance when patients need to be~     prepared for surgery or delivery or in the event of a major bleed. There is no consensus as~     to how patients should be prepared or treated. Different centres use different approaches.~     When the procedure is elective ERT is appropriate but in other situations DDAVP, fresh~     frozen plasma and platelet infusion are possible treatments. Even activated factor VII has~     been used when bleeding was not controlled. As in any other coagulation abnormality,~     treatment should be tailored to the specific cause of the bleeding diathesis. The aim of~     this study is to define the etiology of platelet dysfunction in Gaucher patients.~      Hypothesis: The investigators expect to see a difference between platelets activation~     profile among imiglucerase treated and untreated patients with at least a partial~     restoration of platelets function due to treatment commencement.~   "
130762|NCT01344083|"~     The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine~     eye drops in the topical treatment of seasonal allergic conjunctivitis.~   "
130764|NCT01344057|"~     This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza~     Vaccine Administered to Elderly Subjects.~   "
130818|NCT01343108|"~     Emotional labor is one of the bases that organizations earn profits. Nursing care needs high~     emotional labor to offer health care to patients. Among health carers that emphasize a lot~     on emotional labor, nurses are especially required to include emotional labor as very~     important parts of their jobs.~   "
130765|NCT01344044|"~     This study aims to examine the efficacy of a brain-computer interface system for the~     treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The~     investigators hypothesis is that children with ADHD receiving treatment with the BCI-based~     training will improve to a greater extent than the control group.~      Additionally, we are also conducting an fMRI study involving interested participants, to~     elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to~     help us gain a better picture of brain correlates related to ADHD and understand how the~     intervention can affect the brain.~   "
130766|NCT01344031|"~     This phase I trial studies the side effects and the best dose of MK 2206 (Akt inhibitor~     MK2206) when given with anastrozole, fulvestrant, or anastrozole and fulvestrant in treating~     postmenopausal women with breast cancer that has spread to other parts of the body. Estrogen~     can cause the growth of breast cancer cells. Hormone therapy using anastrozole or~     fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Akt~     inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving Akt inhibitor MK2206 together with anastrozole, fulvestrant, or~     anastrozole and fulvestrant may kill more tumor cells.~   "
130767|NCT01344018|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation~     therapy before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed. It is not yet known whether surgery is more effective with or~     without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.~      PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery~     to see how well it works compared with surgery alone in treating patients with previously~     untreated nonmetastatic retroperitoneal soft tissue sarcoma.~   "
130768|NCT01344005|"~     RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer~     treatment. It is not yet known whether standard medical care is more effective than an~     urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60~     years.~      PURPOSE: This randomized clinical trial is studying standard medical care to see how well it~     works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest~     symptoms who are older than 60 years.~   "
130769|NCT01343992|"~     A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF~     (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment~     with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the~     administration of medications are performed as always and there are no variations. The only~     highlighted procedure in this study is immediately after the embryo transfer. There are two~     groups: one which will rest in bed for 10 minutes after the transfer and one which will not~     rest after the transfer. Both procedures are common, usually depending on the habitual~     clinical practice of each clinic internationally. Patients from both group receive the~     routine post transfer instructions and treatment.~   "
130770|NCT01343979|"~     This retrospective study will analyse all PCR-proven H1N1 cases from the influenza season~     2009/2010 treated within the styrian LKH hospital network. For this purpose all~     PCR-positive case files are reviewed in Medocs (electronic patients database) and data~     regarding clinical presentation, laboratory and radiological findings, treatment, outcome~     and preexisting underlying chronic illnesses will be systematically collected. In a second~     step the same data collection will be performed in a group of PCR-negative patients, which~     were tested during the influenza season 2009/2010 for influenza-like illness. The data from~     the PCR-positive group will be compared to the data from the PCR-negative group. We expect~     significant differences between the proven and unproven group regarding the primary~     presentation at hospital. Based on these results a clinical score will be developed. This~     score should improve H1N1 case identification in emergency departments, even if specific~     diagnostic test are negative (rapid antigen testing) or still pending (PCR), reduce the~     number of missed hospitalized H1N1 infection and optimize the decision making process in~     emergency departments regarding which patient has to be admitted with infection control~     measures and which not, and as infection control measures are expensive (face masks, gloves)~     and limited (isolation room), such a score should also reduce unnecessary expense. To~     evaluate the sensitivity and specificity of the score a prospective study will follow in the~     influenza season 2010/2011.~   "
130771|NCT01343966|"~     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to~     evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's~     Disease.~   "
130772|NCT01343953|"~     This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or~     Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in~     the absence of an HLA identical donor;~   "
130773|NCT01343940|"~     Project Dulce is designed to test a new approach to delivering family support, in the~     context of the primary care medical home. The target population to be served is infants~     between birth and 6 months old and their families who receive primary care at Boston Medical~     Center. A dulce family partner will reach infants and families through their routine health~     care visits during their first six months of life and provide them with support for unmet~     legal needs, screen infants for developmental problems, screen families for mental health~     problems, and improve families' knowledge of child development. The control group will~     receive training on safe sleep and safe transportation for their newborn.~   "
130774|NCT01343927|"~     A randomized controlled trial for chronic low back pain in predominantly minority~     populations with three treatment arms: yoga, physical therapy, and education. Four cohorts~     of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education).~     Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain~     medication use, treatment adherence, and health-related quality of life.~   "
130775|NCT01343914|"~     This retrospective observational study will analyse demographic, clinical and~     treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who~     had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based~     first-line therapy. Data will be collected for approximately 9 months.~   "
130776|NCT01343901|"~     This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) as~     first-line treatment in patients with colorectal cancer and potentially resectable liver~     metastases. Data will be collected from each from each patient for 36 months.~   "
130778|NCT01343875|"~     Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the~     art treatment is surgical procedure.~      Objective: Evaluation of the Surgical procedure among patients that suffered from Methods:~     The investigators will review files from 2003-2010 of patients that gone through the~     operation. The investigators will record pre-operation and post-operation process including~     complications and rehabilitation. The investigators will invite them to the clinic for~     exams, clinical questionnaires.~   "
130779|NCT01343862|"~     In this study of patients with moderate traumatic brain injury with frontal brain contusions~     patients will be randomized to treatment with a single dose of either D-cycloserine or~     placebo given 48-72 hours after injury.~      Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to~     assess whether treatment with a single dose of D-cycloserine improves cognitive outcome~     after moderate brain injury.~   "
130780|NCT01343849|"~     Intend of use: A blood test for Cancer Associated Auto Antibodies (CAAA) aimed for better~     diagnostic management of suspected subjects with breast pathology~      Study Description: Blood is collected form patients and serum is tested for the presence of~     CAAA on experimental test kit.~      Objectives: To assess the effectiveness of the CAAA test.~      Patient Population: The study population will include any women with suspected breast mass~     detected by any conventional method, scheduled for biopsy, which will result with a~     pathological verification of the suspected mass.~      Target Population: The target population will be any women with suspected breast mass~     detected by any conventional method, that today, is scheduled for biopsy.~      Structure: Subjects that will be enrolled for the study will be checked for the presence of~     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the~     physicians in the participating centers.~      Sample Size: Total of 1000 samples, of which 620 samples will ensure at least 124 true~     positive breast cancer subjects verified by biopsy, and 124 true negative breast cancer~     subjects verified by biopsy. Additional 400 samples will be used for calibrations and~     training sets.(Multi center study, statistical rationale provided below).~      Primary Effectiveness Variables: The effectiveness of the test will be defined by the~     specificity of the test conditionally that the sensitivity is not lower than a pre-defined~     level of 95%.~      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.~      Study Sponsor: Eventus Diagnostics Ltd.~      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical~     trials. All data will be stored in a protected internet-based database, and any changes of~     the data will be traced and recorded.~   "
130781|NCT01343836|"~     This study is designed to compare the treatment of 2 groups in patients with Achilles~     tendinopathy: autologous tenocytes injection in combination with exercises versus saline~     injection in combination with exercises~   "
130782|NCT01343823|"~     A double-blind, randomized, controlled trial comparing the safety and effectiveness of~     conventional therapy with ecallantide to conventional therapy with placebo.~   "
130783|NCT01343810|"~     The goal of this study is to better understand the potential value of reducing stress to~     ameliorate a cluster of biological and behavioral factors implicated in cardiovascular~     disease (CVD) risk. These factors include psychological distress, poor sleep quality, and~     exaggerated physiological responses to emotional stress. Results will be used to develop an~     innovative brief intervention to reduce risk for CVD by improving sleep quality,~     ameliorating psychological distress, and attenuating stress physiology.~   "
130784|NCT01343797|"~     The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups :~     FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.~   "
130785|NCT01343784|"~     The purpose of this study is to compare the incidence of catheterization from discharge to 6~     weeks postoperatively when using two methods of post-operative voiding evaluation after a~     mid-urethral sling procedure. The investigators' results may lead to a decreased use of~     indwelling catheters and their associated morbidity after outpatient sling surgery.~   "
130786|NCT01343771|"~     The following randomized controlled trial will examine the effects of one year of~     dehydroepiandrosterone and estrogen replacement therapy (DHEA +ERT) on bone mineral density~     (BMD) and bone marrow composition in adolescents with anorexia nervosa (AN). The~     investigators will use imaging techniques including dual-energy x-ray absorptiometry (DXA),~     peripheral quantitative computed tomography (pQCT), visual assessments of magnetic resonance~     imaging (MRI) data, MR relaxometry and magnetic resonance spectroscopy (MRS) to measure bone~     mineral density and evaluate bone marrow composition. The investigators will also collect~     serum to measure hormonal mediators of the changes observed in both bone density and bone~     marrow composition, including adrenal and gonadal steroids, insulin-like growth factors,~     growth hormone, and ghrelin, adiponectin, and leptin.~   "
130787|NCT01343758|"~     Infants and young children often become infected with gastroenteritis leading to vomiting~     and diarrhea. This can lead to dehydration, one of the most common complaints in the~     Pediatric Emergency Department. These children are often in need of treatment with~     intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear~     which type or how much fluid is the best amount to give. Currently, the most common type of~     IV fluid given is salt water, also called normal saline.~      In contrast to adults, infants and young children with dehydration often have a build up of~     a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general~     malaise associated with gastroenteritis. The investigators feel that giving these children~     IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than~     giving just salt water alone. In a prior study, the investigators have shown that children~     who receive lower amounts of sugar in the IV fluids return to the Emergency Department more~     often for a second visit. Based on this study, the investigators believe that children who~     receive the sugar-salt solution will do better than children who receive just normal saline.~      The investigators will determine if the sugar-salt solution is better by giving equal~     numbers of children the sugar-salt solution and normal saline and then see what happens to~     each child. The investigators will monitor who needs to be admitted, how much each child~     vomits, how much each child drinks, and also the level of acid in the blood before and after~     getting the IV fluid. After the study is completed, the investigators can compare the two~     different groups (children who received the sugar-salt solution versus children who received~     normal saline alone) to determine if one group had greater improvement and better clinical~     outcome than the other.~   "
130788|NCT01343745|"~     The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in~     the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative~     Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated~     after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an~     Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose~     response.~   "
130789|NCT01343732|"~     The purpose of this study is to test whether the combination of deep transcranial magnetic~     stimulation (DTMS) treatment with customary medication for obsessive compulsive disorder~     (OCD) patients is effective than treatment that include only medication.~   "
130790|NCT01343719|"~     The objective of the current study is to investigate safety, tolerability, and~     pharmacokinetics of treatment with BI 661051 rising single doses administered as oral~     drinking solution (powder in bottle) in healthy male subjects.~      The primary objective is to investigate the safety and tolerability of treatment with BI~     661051.~      The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051,~     (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI~     661051 is administered as tablet at two dose levels compared to oral drinking solution and~     (4) to assess the effect on the bioavailability when BI 661051 is administered as oral~     drinking solution after intake of a high fat meal.~      Pharmacodynamic parameters will not be determined within this study.~   "
130791|NCT01343706|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in healthy male genotyped volunteers following oral administration of single~     rising doses.~      The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate~     release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when~     administered as immediate release solid oral dosage compared to oral drinking solution and~     (3) to compare the safety and pharmacokinetic profiles between two different groups of~     genotyped subjects.~   "
130792|NCT01343693|"~     This study is being performed to document the outcomes of subjects using our MaxAn Anterior~     Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for~     2 years.~   "
130793|NCT01343680|"~     The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs)~     with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per~     week, in preventing CVC occlusions.~   "
130794|NCT01343667|"~     The objective of this study is to provide an ongoing evaluation of clinical outcomes~     associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for~     embolic protection during carotid artery stenting.~   "
130795|NCT01343654|"~     Many drug users living with HIV demonstrate inadequate levels of medication adherence, and~     are at high risk for disengaging from care. HIV positive drug users are at even higher risk~     of poor medication adherence and treatment dropout when living far from treatment centers.~     Rural residence is common in the U.S. South where rates of new HIV infections are~     disproportionately high, especially among ethnic minorities. While there are efficacious~     interventions to improve HIV treatment adherence, only a few have targeted drug users, and~     these have required patients to come into research clinics for adherence interventions.~     Transportation problems, poverty, isolation, and stigma are known barriers to accessing~     adherence support among rural drug users with HIV.Additionally, most adherence interventions~     aim to increase adherence, but come too late, unable to respond in real time to adherence~     lapses to help patients re-initiate appropriate medication use while remaining in their~     natural environments. There is a pressing need to develop tailored, scalable interventions~     that detect nonadherence episodes in real time and enhance adherence to HIV treatment~     immediately. Building interventions upon familiar, existing technology could extend their~     reach into communities of non-urban patients living with HIV, overcoming common barriers to~     care, and could ultimately be scaled up to help drug using HIV+ patients nationwide.~      The investigators propose to develop and test the feasibility and promise of a combined HIV~     adherence assessment and intervention application for rural drug users using an available,~     familiar technology whose reach will grow exponentially: text messaging via mobile phones.~     By 2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration~     projected by 2013. While technology adoption is often slower in under-served communities,~     the trend is different with mobile phone technology. African-Americans are using more mobile~     phone minutes per capita and increasing their use at a higher rate compared with other~     ethnic groups. This technology has great potential to reduce health disparities. In this~     project, the investigators will develop and test the feasibility and promise of a text~     messaging application and system using Ecological Momentary Assessment methods to detect~     nonadherence and drug use and immediately intervene to improve HIV treatment adherence in~     drug users living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a~     Stage 1b/2a project in the Stage Model of Behavioral Therapy Development that will develop~     novel interventions and methods, and generate preliminary estimates of effect sizes that~     will determine whether a larger clinical trial with extended follow-up and~     cost-effectiveness evaluation is warranted.~      The specific aims of this project are:~        1. To identify assessment and intervention features relevant to the adherence barriers and~          drug use patterns of rural and non-urban HIV+ drug users using formative methods~          including:~             -  structured interviews and focus groups to identify specific barriers to adherence~               and engagement in care and needs related to drug craving and drug use that should~               be addressed by the intervention~             -  iterative usability testing of components and drafts of the intervention~        2. To create a text messaging mobile phone application and system (Treatment Extension by~          Texting, Text) to assess and improve HIV treatment adherence and drug use in real time~           --Text will be built upon a piloted unidirectional personalized text phone application~          and system, STeM, and will include pre- and post-programming usability testing~        3. To test the feasibility and promise of the assessment and intervention tool in a~          randomized pilot trial of rural HIV+ drug users with detectable viral load (VL)~          comparing Text to usual care~             -  Feasibility: Identify recruitment rates, consent rates, participant flow,~               completion rates, and variance of key covariates and outcome variables~             -  Promise: determine point estimates and the precision of effects for primary and~               secondary adherence outcomes including pharmacy refills and unannounced pill~               counts (medication adherence), missed visit percentage (treatment engagement), VL,~               and drug craving and drug use.~   "
130796|NCT01343407|"~     Part I of the study will verify optimal execution of the procedures and acquisition of~     satisfactory samples that will be utilized in the main study (Part II); no drug will be~     administered. Part II will assess the effect of multiple doses of MK-1029 on the changes in~     allergen-induced sputum eosinophils and changes in allergen-induced late asthmatic response~     (LAR) when compared to placebo.~   "
130797|NCT01343394|"~     The objectives of this study are:~        1. To see if autologous human umbilical cord blood treatment is safe for children with~          acquired hearing loss, and~        2. To determine if late functional outcome is improved following autologous human~          umbilical cord blood treatment for children with acquired hearing loss.~   "
130798|NCT01343381|"~     Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of~     this drug have differing clinical effects despite both having exactly the same regulation~     and marketing specifications?~   "
130799|NCT01343368|"~     Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will~     receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT~     will be observed.~   "
130800|NCT01343355|"~     An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with~     HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will~     receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12~     weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8~     weeks. Efficacy will be monitored by measuring clinical scores including motor and urination~     function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid.~     Safety will be evaluated at the same time.~   "
130801|NCT01343342|"~     The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic~     risk factors are influenced by genetic variations within genes acting as fatty acids~     sensors.~   "
130802|NCT01343329|"~     Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state~     accompanied by elevated levels of plasma catecholamines. In its more severe presentation,~     the hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal~     alteration in vital signs, including tachycardia. The investigators hypothesize that~     intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states~     as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV~     esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a~     pre-specified level (< 100 bpm) after Traumatic Brain Injury (TBI). Heart rates will be~     recorded continuously as well as hourly.~   "
130803|NCT01343316|"~     The purpose of this study is to determine the benefit of feeding critically-ill patients~     beyond the stomach (post-pyloric). Furthermore, because of the advent of two new~     post-pyloric feeding tubes (Tiger 2 and Syncro BlueTube) designed to improve post-pyloric~     placement, the investigators will be evaluating the benefits of those two tubes as well.~   "
130804|NCT01343303|"~     The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335~     and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken~     down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis~     patients. This study will also assess the effectiveness of JNJ-39439335 on pain.~   "
130805|NCT01343290|"~     The purpose of this study is to assess the effect of food on the absorption of canagliflozin~     in the body when canagliflozin is taken with and without food by healthy volunteers~   "
130806|NCT01343277|"~     The purpose of this study is to evaluate whether overall survival for the trabectedin group~     is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or~     leiomyosarcoma).~   "
130819|NCT01343095|"~     This study seeks to examine the effects of overnight noise reduction in critically ill~     patients who are receiving mechanical ventilation. The investigators will randomly place~     subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs~     and noise-canceling headphones. The investigators will monitor for safety, and will measure~     the amount of delirium experienced by subjects, record the amount of sedating and~     painkilling medicines required, and measure sleep quality during the study, among other~     information. The investigators will also measure noise levels experienced by patients in~     each group. The investigators predict that the use of overnight noise reduction will be safe~     and will reduce the amount of delirium by improving the quality of sleep in critically ill~     patients.~   "
130807|NCT01343264|"~     The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is~     still controversial. The selection criterion to perform either Extrapleural Pneumonectomy~     (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary~     status of the patient, tumor stage and intraoperative findings but also on surgeons'~     decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP)~     competes against EPP as surgical therapy modality. Both surgical approaches are~     cytoreductive treatment options. The aim is to remove all gross disease and to achieve~     macroscopic complete resection.~      Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing~     surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo~     EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for~     MPM are based on retrospective analyses and their interpretation is difficult because of~     inhomogeneous patient groups studied.~      The aim of our study was to analyze the feasibility and results of RP as surgical therapy~     modality in a standardized trimodality therapy concept.~   "
130808|NCT01343251|"~     The main objective of this research study was to compare the following outcomes between~     patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed~     catheter for dialysis access over one year: quality of life and incidence of bacteremia,~     vascular interventions, hospitalizations, and death.~   "
130809|NCT01343238|"~     The study will investigate whether physical exercise, or dietary restrictions, or a~     combination of both, among overweight and obese postpartum women lead to a significantly~     larger reduction in weight in a longer perspective, compared to similar women not receiving~     the intervention. The study also will investigate the effects on body composition,~     cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68~     women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1)~     physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions~     and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1~     yr after trial initiation. To date only studies showing short term (12 wk) effects exist.~     Our study is the first to include four intervention groups, so that separate effects of~     physical activity and dietary restriction and their interaction, can be assessed. Further,~     the investigators will estimate effects on body composition taking body water into account~     and estimate total energy expenditure with higher precision than previously. Overweight and~     obesity is an escalating problem in Sweden. Sustainable weight reduction programs are~     urgently needed. During the postpartum period, women may be motivated to lose weight.~     Information aimed at promoting life style changes among overweight and obese women could in~     a longer perspective be integrated in the regular maternal health care in Sweden.~   "
130810|NCT01343225|"~     2. Objectives~        1. To determine the vitamin D status of African-American HIV patients who are~          HIV-treatment naïve.~        2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor~          regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.~        3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen~          to a regimen that does not contain these drugs.~        4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir)~          to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).~      Hypothesis~      The investigators hypothesize that patients receiving efavirenz will be more likely to have~     lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that~     efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and~     1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate~     that patients on a tenofovir-containing regimen will be more likely to have progression of~     bone density loss compared to those in the non-tenofovir-containing regimen.~   "
130811|NCT01343212|"~     The investigators are measuring hepatocellular carcinoma(HCC)stiffness using Acoustic~     Radiation Force Impulse (ARFI) technique to enhance the diagnostic accuracy for HCC~     stratifications and treatment efficacy.~   "
130812|NCT01343186|"~     This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of~     Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose~     at different levels.~   "
130813|NCT01343173|"~     Background: Complete molecular remission under imatinib, therapeutic interruption possible~     for patients in complete remission proved in different trials.~      Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular~     remission during two following years. The objectives of this study are to determine the rate~     of patients without a molecular relapse and so the rate of molecular relapse, to determine~     and to seek for clinical and biological CML-related factors predictive for a molecular~     relapse after imatinib discontinuation. These objectives require to increase the number of~     study patients to be enrolled for accurate statistical considerations. It will allow to~     predict which patients have to be proposed for discontinuation without risk of molecular~     relapse and to select the patients who need to continue or reinforce the treatment to~     achieve a complete long term eradication of the disease.~   "
130814|NCT01343160|"~     Generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the~     endoscopic and percutaneous treatment of benign biliary strictures.~   "
130815|NCT01343147|"~     Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA).~     Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal~     painful conditions. However, the efficacy of superficial heating is controversial.~     Furthermore, no clinical trials have yet directly compared the effects of these treatment~     modalities in knee OA. Hence, the purpose of the present study is to compare the effects of~     deep and superficial hyperthermia, induced via microwave diathermy and hot packs,~     respectively, on pain and function in patients with symptomatic knee OA.~   "
130816|NCT01343134|"~     The purpose of this study is to evaluate the correlation between morphologic changes in the~     outer retina and visual function after successful repair of rhegmatogenous retinal~     detachment with macula off.~   "
130817|NCT01343121|"~     The purpose of this study is to test the hypothesis that plasma, peripheral blood~     mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours~     post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months~     from the end of radiotherapy.~   "
130820|NCT01343082|"~     Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be~     evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label,~     multicenter study.~   "
130821|NCT01343069|"~     The study investigates the impact of the introduction of a surgical checklist on the~     incidence of complications and mortality within 30 days after surgery in patients scheduled~     for elective non-cardiac surgery. Patients scheduled for elective surgical procedures~     lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary~     care center. Study design is an open trial before and after intervention (implementation of~     the checklist safe surgery saves lifes).~   "
130822|NCT01343056|"~     Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm,~     randomized study with each group receiving a different method of follow up. The 4 arms will~     be evaluated based on clinical indicators, goal achievement and patient satisfaction.~   "
130823|NCT01343043|"~     The purpose of this early (pilot) clinical trial is to test the effects (both good and bad)~     of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1~     peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.~   "
130824|NCT01343030|"~     Breast implants are currently used for cosmetic breast augmentation and in breast~     reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat~     is injected around the periphery of a breast implant to camouflage the transition between~     implant and the body. The investigators propose to show mammography images of women who have~     had breast implants with fat grafting to informed and blinded radiologists and evaluate~     their readings of the images.~      Hypothesis: with mammographic screening, radiologists will be able to distinguish between~     findings associated with fat grafting and those which are suspicious for breast cancer.~   "
130825|NCT01343017|"~     General anaesthesia impairs respiratory function in overweight patients. The investigators~     wanted to compare arterial concentration of sevoflurane and oxygen in overweight patients~     ventilated with increased tidal volume, or normal tidal volume with added 10 cm H2O PEEP.~   "
130826|NCT01343004|"~     The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid~     hormone-related peptide, is effective in preventing fractures in postmenopausal women with~     severe osteoporosis who are at risk of fractures.~   "
130827|NCT01342991|"~     This is a randomised trial to compare both the procedures and the difference in their~     immediate postoperative pain, recovery and quality of life.~   "
130828|NCT01342978|"~     This research is being done to understand more about a sexually transmitted virus called~     Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.~   "
130829|NCT01342965|"~     This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva~     (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in~     patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor~     (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg~     orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8~     plus cisplatin 75 mg/m^2 iv on Day 1.~   "
130830|NCT01342952|"~     An open label, long term extension to Study AMB112529. All subjects may remain in the~     extension study for a minimum of six months. Beyond the six month period, subjects may~     continue in the extension study until one of the following conditions is met:~      the subject turns 18 years of age (when the subject can receive marketed product) the~     product is approved and available for use in the subject's age group, development for use in~     the paediatric population is discontinued. the subject decides he/she no longer wants to~     participate in the study, the investigator considers it is in the best interest of the~     subject to discontinue ambrisentan (e.g. for safety reasons).~      The primary objective is the long-term safety and tolerability of ambrisentan in the~     paediatric PAH population. Secondary objectives are all cause mortality and change from~     baseline in Study AMB112529 on efficacy parameters.~   "
130831|NCT01342939|"~     The purpose of this study is to describe the incretin effect and postprandial incretin~     response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In~     sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and~     without treatment. In healthy subjects the purpose is also to investigate the incretin~     effect under increased levels of endogen incretin hormones.~   "
130832|NCT01342926|"~     The purpose of this study is to determine the safety and efficacy of GSK933776 in the~     treatment of geographic atrophy secondary to age-related macular degeneration.~   "
130833|NCT01342913|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone~     Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate~     50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.~   "
130834|NCT01342900|"~     Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk~     surgical patients may decrease the risk of postoperative complications.~      Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The~     investigators want to see if an algorithm aimed at optimizing intraoperative tissue~     oxygenation reduces perioperative complications as well as length of stay in the intensive~     care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these~     patients.~   "
130835|NCT01342887|"~     This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone~     hydrochloride when given together with cyclosporine and pravastatin sodium and to see how~     well they work in treating patients with relapsed or refractory acute myeloid leukemia~     (AML). Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby~     improve chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer~     cells by blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy,~     such as etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     cyclosporine together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may~     kill more cancer cells~   "
130836|NCT01342874|"~     Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus~     (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of~     pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of~     insulin resistance. Dietary supplementation of inositol improves insulin resistance in~     patients with GDM.~   "
130876|NCT01342354|"~     This purpose of this study is to determine the highest tolerated dose of Stereotactic Body~     Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic~     cancer.~   "
130837|NCT01342861|"~     Hospital undernutrition is a common health problem [1]. As a countermeasure, French~     hospitals have created a system of cross-function committees for feeding and nutrition~     called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions~     for improving patient nutritional status include improving the characteristics of the food~     provided to increase both protein and calorie intake in at-risk patients that do not require~     enteral or parenteral nutrition. Looking at the various daily meals, the investigators~     considered that breakfast following the night fast would be the easiest meal to improve .~      Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition~     of protein (milky food in the breakfast) Current care~   "
130838|NCT01342848|"~     Although successful, percutaneous coronary interventions (PCI) with stent implantation may~     be hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial~     infarction (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA)~     of an occluded coronary artery has been documented to produce an improved myocardial~     perfusion rate and significant survival advantage. To date, beyond feasibility and safety~     studies no clinical benefit has been yet documented with the use of TA before stent~     deployment in the setting of acute coronary syndromes (ACS) outside acute STEMI. The~     investigators hypothesize that TA before stent deployment reduces the thrombus/plaque burden~     - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes~     (ACS) outside acute STEMI.~   "
130839|NCT01342835|"~     The investigators hypothesize that patients anesthetized with sevoflurane have more pain,~     postoperatively, than those anesthetized with propofol.~   "
130840|NCT01342822|"~     The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial~     (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1~     randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in~     the reimbursed indications per-country~      All subjects will be screened per the protocol required inclusion/exclusion criteria.~   "
130841|NCT01342809|"~     The study hypothesis is that follow up from general practitioner after hospitalization for~     self poisoning will decrease suicidal behaviour.~   "
130842|NCT01342796|"~     This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and~     hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit~     influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated~     children aged 6 to <36 months.~   "
130843|NCT01342783|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research trial is studying biomarkers in samples from young patients with soft~     tissue sarcoma.~   "
130844|NCT01342770|"~     This pilot phase II trial studies how well pioglitazone works in treating patients with~     stage IA-IIIA non-small cell lung cancer. Pioglitazone hydrochloride may slow the growth of~     tumor cells and may be an effective treatment for non-small cell lung cancer.~   "
130845|NCT01342757|"~     This clinical trial is studying magnetic resonance spectroscopy imaging in predicting~     response in patients to vorinostat and temozolomide in patients with recurrent, progressive,~     or newly diagnosed glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Vorinostat may also help temozolomide work better by making~     tumor cells more sensitive to the drug. Imaging procedures, such as magnetic resonance~     spectroscopy imaging, may help measure the patient's response to vorinostat and temozolomide~     and allow doctors to plan better treatment.~   "
130846|NCT01342744|"~     The purpose of this study is to determine the effects of metformin on cardiovascular risk~     factors in postmenopausal women with metabolic syndrome.~   "
130847|NCT01342731|"~     30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will~     be enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion~     for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on~     effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture~     of clinical specimen from the site of infection will be obtained on day 3 and at the end of~     tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse,~     death. Microbiological outcome is assessed at the end of treatment and classified as~     eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day~     mortality and infection-related mortality will be determined. Length of stay will also be~     determined.~   "
130848|NCT01342718|"~     The aims of this study are to investigate the effect of famous herbal formula extract and~     probiotics on irritable bowel syndrome with diarrhea, and to determine whether these two~     experimental items affect intestinal permeability and the composition of intestinal~     microbiota.~   "
130849|NCT01342705|"~     The main objective of the study is to assess in patients with compensated alcoholic~     cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in~     order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular~     carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1)~     episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO~     during follow-up.~   "
130850|NCT01342692|"~     In order to improve the overall survival benefit observed with AZA in higher risk MDS, its~     combination with other active drugs in MDS must be tested.~      Among drugs that have demonstrated to be active as a single agent in MDS and have~     preclinical potential additive or synergistic activity with AZA are Histone deacetylase~     (HDAC) inhibitors including Valproic acid, Lenalidomide and idarubicin. Phase I studies have~     already been conducted or are being conducted combining those agents to demethylating~     agents, showing a low toxicity profile and significant responses in high risk MDS. In this~     phase II randomized trial, we want to identify the most promising combination of Azacitidine~     and another drug (among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk~     MDS, by comparison to Azacitidine alone. Of note, based on efficacy and toxicity, one or~     several combinations may be stopped, and others, previously tested in phase I trials,~     included after protocol amendment.~   "
130851|NCT01342679|"~     The purpose of this study is to evaluate complete molecular response of Dasatinib in~     patients for Philadelphia chromosome-positive chronic myeloid leukemia~   "
130852|NCT01342666|"~     -  This is a randomized, open-label, single blind, clinical trial~        -  The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.~        -  The hypothesis was that two daily tomatoes during one month will increase the HDL-c~          levels.~        -  Since a placebo of tomatoes cannot be done, the control group will receive same~          proportion of cucumber because 1) it was not possible to have a tomato placebo; 2)~          cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the~          required quantity can be measured in the same way.~        -  The intervention was during 1 month and was assigned by randomization.~        -  Personnel who did the clinical and biochemical evaluation were blinded for the~          intervention.~        -  Lipid profile was measured before and after the intervention.~        -  Confounding factors such as daily physical activity, diet, consumption of fish or~          alcoholic beverages, smoking status were considered during statistical analyses.~   "
130853|NCT01342653|"~     Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric~     cancer. The goal is to get 1C level of evidence (patient died with standard treatment,~     with this treatment some of them survive) in terms of disease free survival and overall~     survival.~      Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to~     have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus~     simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease~     by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are~     discharged, they will follow a systemic adjuvant chemotherapy protocol.~   "
130854|NCT01342640|"~     This single arm, open label, multicenter study will evaluate the safety and change in~     hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in~     patients with chronic renal anemia who are not on dialysis. Patients will receive as a~     recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The~     starting dose is dependent on the patient's weight. Dose adjustment may be required due to~     inadequate or excessive treatment response. The anticipated time on study treatment is 28~     weeks.~   "
130855|NCT01342627|"~     Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65~     years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other~     currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.~      Each patient treated with sorafenib enrolled in the study will be trained to observe the~     management tool for skin care. A study period of 3 years was estimated as follows: an~     enrollment period of 24 months and a further follow-up period of 12 months.~      Objectives of the trial Primary objective The primary aim of this trial is the evaluation of~     the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction~     (HFSR).~      Secondary Objectives~      TO assess:~        -  The frequency of dose discontinuation, interruption and reduction~        -  The incidence of any grade diarrhoea, and other adverse events~        -  The overall Response Rate according to the RECIST criteria.~        -  Progression free survival (PFR) in study population and comparison of PFS between age~          sub groups in the current study population~   "
130856|NCT01342614|"~     The objective of this study is to investigate the effect of metformin on the correlation~     between hyperinsulinemia and hypertension.~   "
130857|NCT01342601|"~     Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection~     against external agents like aeroallergens. The effects of Ectoin containing nasal spray and~     eye drops have already been demonstrated in several studies with adult Seasonal Allergic~     Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of~     allergic rhinitis without resulting in any significant adverse events.~      The aim of this clinical investigation is to demonstrate the safety, tolerability and~     efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR~     patients. It is assumed that Ectoin containing products show an excellent safety profile and~     very good tolerability together with a potent efficacy in the treatment of SAR.~   "
130858|NCT01342588|"~     The purpose of this study is to establish the accuracy of pedicle positioning using~     continuous electrical pulse during screwing. Additionally, the investigators evaluate if~     this maneuver can prevent neurological injury during track creation and screwing in lumbar~     and thoracic spine instrumentation surgery~   "
130859|NCT01342575|"~     The purpose of this study is to establish which of five different maneuvers could bring the~     best trans-operatory x-ray exposure during anterior cervical surgeries with the higher~     security~   "
130860|NCT01342562|"~     Spinal block is the most common anesthetic technique for transurethral resection of~     prostatectomy (TURP). Most patients undergoing TURP are elderly and frequently present with~     cardiopulmonary and endocrine diseases. Low-dose local anesthetic is commonly administer to~     limit the block level to minimize the hemodynamic changes. However, sometimes it may not~     provide an adequate level of sensory block. Thus, intrathecal additive is frequently~     administer with local anesthetic to improve analgesic effect.~      Dexmedetomidine(DXM), a selective 2-adrenoreceptor agonist, has been used in the epidural~     space in humans without any reports of neurological deficits. Previous clinical studies~     showed that intravenous dexmedetomidine administration prolonged the sensory and motor~     blocks of bupivacaine spinal analgesia. But clinical studies about the use of intrathecal~     DXM with local anesthesia in humans are scarce in the literature. Kanazi et al. found that~     3μg DXM added to 12 mg spinal bupivacaine produced the significant short onset of sensory~     and motor block as well as significantly longer duration of sensory and motor block than~     bupivacaine. And Al-Mustafa et al. reported that intrathecal dexmedetomidine as an adjuvant~     to 12.5mg bupivacaine in spinal anesthesia has a dose dependant effect on the onset and~     regression of sensory and motor block.~      In our previous study, low-dose diluted bupivacaine 5 mg provided sufficient anesthetic~     level when opioid was added with local anesthetic. However, opioid-induced side effects,~     such as pruritus, nausea, or vomiting, could be an obstacle in common use. The aim of this~     study is to evaluate whether DXM-low-dose bupivacaine spinal anesthesia can provide the~     effective spinal anesthesia and postoperative analgesia with minimal side effect compare to~     the local anesthetic only group.~      This study was conducted in a randomized, double-blind, controlled fashion. Patients were~     randomly allocated to DXM group or Saline group. DMT group received hyperbaric bupivacaine~     0.5% (1.2 ml) (6 mg) in dextrose 8% solution + DMT 0.3 ml (3 µg)－in total, bupivacaine 0.4%~     (1.5 ml) intrathecally and Saline group received hyperbaric bupivacaine 0.5% (1.2 ml) (6 mg)~     in dextrose 8% solution + normal saline 0.3 ml －in total, bupivacaine 0.4% (1.5 ml)~     intrathecally. After spinal block, the level of sensory block, defined as the dermatomal~     segment with loss of pain sensation to pin-prick with a 22 G hypodermic needle and cold~     sensation to alcohol swab was measured every 2 min after intrathecal injection. The~     investigators recorded the peak sensory block level, time to peak block level from~     intrathecal injection, blood pressure and heart rate, and analgesic supplementation during~     operation. The maximum motor block level was assessed according to the modified Bromage~     scale. During postoperative period, the frequency of analgesic requirement, time to the~     first analgesic request, and pain scores were evaluated by blind investigator.~   "
130861|NCT01342549|"~     The purpose of this research study is to understand the effectiveness of valproate (a common~     mood stabilizer) to further reduce alcohol misuse when given in addition to attending an~     alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main~     goal of this project is to understand if people receiving valproate will have a better~     recovery than people receiving the standard treatment for alcohol dependence: naltrexone.~   "
130862|NCT01342536|"~     Primary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping~     With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and~     treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in~     greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at~     the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-,~     6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework~     completion, class-participation level; Client Satisfaction Inventory; and Cornell Service~     Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression~     at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months~     post-intervention. The investigators hypothesize the OHDC will result in greater reduction~     in depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures:~     Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression~     Symptoms. Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports~     of mental and physical health status and reducing self-reports of perceived disability. The~     investigators hypothesize the OHDC compared to the CWD will result in greater self-report~     of: 3a. improved mental and physical health status, and 3b. reduced self-report of~     disability at the immediate end of the intervention and 3-,6-, 9-, 12- months~     post-intervention. Outcome measures: SF-12 Health Survey, and World Health Organization~     Disability Assessment Schedule.~      Public Health Impact: Based on CAI research, the OHDC has the potential to be four times~     more effective than the CWD. If our hypotheses are proven, the OHDC will be the first~     evidence-based culturally adapted depression intervention designed specifically for African~     American men and women between the ages of 30-60.~   "
130863|NCT01342523|"~     This is an evaluative study of three National Cancer Institute (NCI) smoking cessation~     resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS~     counseling phone calls. The following are the identified critical questions: (1). How~     effective is each of the tobacco interventions (websites [smokefree.gov & women~     smokefree.gov], NCI's Cessation Quitline counseling services operated by the Cancer~     Information Service (CIS) (2). How do they compare with alternative intervention strategies?~     (3). Which types of interventions appear to work best together (due to additive or~     interactive effects)? (4). How do these interventions work? (5). How much are these~     interventions used, and what are their relative use rates? (6). Are there important~     differences in effectiveness or use rates as a function of gender, SES, or other important~     person factors? We believe that the research study will address all of these questions, as~     well as some less central ones.~   "
130864|NCT01342510|"~     Since the introduction of propofol into routine anesthesia practice, the phenomena of pain~     on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the~     release of bradykinin on injection. This release causes a painful burning sensation in the~     patient at the site of injection. Anesthesia providers have attempted a large number of~     remedies to prevent this pain on injection. Previously explored ideas include injecting~     propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment~     with numerous other medications. Currently, pretreatment with lidocaine is commonly~     administered to prevent propofol injection pain. No studies to date have looked at the~     combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on~     injection caused by propofol. In addition, the administration protocols that have been~     studied thus far do not mirror clinical practice at the University of Wisconsin. The~     investigators propose studying the use of magnesium and lidocaine in a single syringe for~     pretreatment of propofol related pain on injection.~   "
130865|NCT01342497|"~     The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on~     the healing of complicated diabetic foot ulcers.~   "
130866|NCT01342484|"~     The main objective of this study is to identify the dose of linagliptin in paediatric~     patients.~      Other efficacy objectives include the comparison of the lowering effect of linagliptin low~     dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of~     treatment.~      Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD)~     and the PK/PD relationship of linagliptin in the paediatric population.~   "
130867|NCT01342471|"~     Physical inactivity is a major public health problem and a primary contributing factor to~     the obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines~     (30 min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently~     site lack of time as a barrier for engaging in PA. The Physical Activity and Leisure-time~     Study examines an approach convert sedentary TV watching into active TV watching time by~     having adults step in place during commercials (TV commercial stepping).~   "
130868|NCT01342458|"~     The purpose of this study is to determine whether inexpensive, flexible and non-heeled~     footwear is effective in improving of clinical, functional and gait biomechanics in elderly~     women with knee osteoarthritis.~   "
130869|NCT01342445|"~     The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a~     prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college~     students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students~     with ADHD from two universities (University of Rhode Island and Lehigh University) completed~     a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral,~     psychosocial, and academic functioning were completed on a weekly basis across five~     conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).~   "
130870|NCT01342432|"~     The purpose of this study is to compare the effects of a balance reeducation protocol and an~     evidenced based protocol on pain, function and postural control of low back pain patients.~   "
130871|NCT01342419|"~     This single-center, investigator-masked, crossover study is designed to investigate the~     circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT)~     before and after intervention with a commonly used ocular hypotensive medication,~     brimonidine.~   "
130872|NCT01342406|"~     This study will compare aqueous humor dynamics in adults with primary open angle glaucoma~     that receive Selective Laser Trabeculoplasty (SLT).~   "
130873|NCT01342393|"~     Proof of concept study is to compare the best corrected visual acuity obtained via~     First-Sight lenses with the clinical gold standard of manifest refraction and~     autorefraction.~   "
130874|NCT01342380|"~     Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing~     pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial~     conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic~     syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB #~     07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with~     bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer~     to the respective IRB protocols for more information.~   "
130875|NCT01342367|"~     The purpose of this study is see if quality of life is improved in patients receiving oral~     hormone therapy compared to standard of care. The study will also compare survival rates~     between patients receiving oral hormone therapy and those receiving standard of care.~   "
130877|NCT01342341|"~     The overall goals of this study are to (1) expand knowledge about interactions of~     chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in~     moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on~     visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.~   "
130878|NCT01342328|"~     Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a~     common occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and~     can independently result in serious consequences including higher mortality rate. Delirium~     develops through a complex interaction between the patient's baseline vulnerability (risk~     factors) and precipitating factors such as disruption of sleep that may occur during~     hospitalization. While sedative-hypnotic agents that are used to facilitate hypnosis and the~     management of mechanically ventilated patients converge on the neural substrate that mediate~     endogenous sleep, they do so at different juncture points depending on its molecular~     mechanism of hypnotic action. Hypnotic agents that modulate the GABAA receptor converge at~     the level of the hypothalamus while α2 adrenergic agonists converge on sleep pathways within~     the brainstem. This translational project seeks to determine whether sedation mediated by~     activation of α2 adrenoceptors (dexmedetomidine) is more like natural sleep than that~     provided by a sedative agent that modulates the GABAA receptor (propofol). The investigators~     will examine volunteers who will be monitored continuously by electroencephalography (EEG)~     and whole-brain functional connectivity by magnetoencephalography (MEG) during each of three~     sleep stages, namely, that induced by dexmedetomidine, propofol, or saline (natural sleep,~     control). The two drug-induced sleep regimens will be compared to natural sleep using EEG~     and brain connectivity by MEG~   "
130879|NCT01342315|"~     To determine if a topical antifungal cream is safe and effective for the treatment of tinea~     cruris~   "
130880|NCT01342302|"~     Breast cancer is distressing for couples in general but even more so when the illness~     strikes at a relatively young age. In addition to common relationship challenges, younger~     couples have to contend with the loss or disruption of age-appropriate goals for themselves.~     Presently, there are virtually no resources designed specifically to assist young couples~     coping with breast cancer. The purpose of this study is to develop and evaluate an online~     educational program geared to the unique needs and demanding schedules of young couples. The~     purpose of the program is to improve couples' relationships and mutual coping. Seventeen~     couples will take part in the 7-week program. They will complete questionnaires before and~     after participating to evaluate the program's helpfulness. This study will allow for the~     creation of a user-friendly, cost-effective tool that could help to improve the lives of all~     young couples coping with breast cancer in the years to come.~   "
130881|NCT01342289|"~     This research is being done to learn more about nonmyeloablative bone marrow transplantation~     (BMT), also known as a mini transplant for patients with blood cancers, using bone marrow~     from a relative.~   "
130882|NCT01342276|"~     Several studies have indicated that heart failure (HF) clinics facilitating patient~     self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and~     HF-related hospitalizations, all-cause mortality, and improve patient quality of life.~     Additionally, national and provincial organizations have identified patient-focused homecare~     initiatives in telehealth as demonstrating great promise for health service. Our pilot study~     demonstrated the feasibility of the internet based vHFC and supports the investigation of~     this intervention in patients with HF.~      The purpose of our single-blinded randomized trail is to investigate the efficacy of an~     Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.~      Hypotheses~      A. Participation in a vHFC emphasizing patient self-management and monitoring will result in~     improved functional capacity compared to usual care in patients with HF.~      B. Participation in a vHFC emphasizing patient self-management and monitoring will result in~     improved health indices such as, self-management skills, quality of life, levels of B-type~     natriuretic peptide and healthcare utilization compared to usual care in patients with HF.~      Our objectives of the vHFC study is as follows:~        1. To establish a cohort of 186 patients with HF.~        2. To determine the benefits of participating in the vHFC over usual care at 12 months~          with respect to exercise capacity.~        3. To compare the changes in other risk factors and lifestyle behaviours between the vHFC~          and usual care patients.~   "
130883|NCT01342263|"~     In 2005, more then one-third of Canadians were burdened with one or more chronic diseases.~     Patients with one chronic disease often have, or are at risk for, another chronic disease.~     This group of complex patients represents a substantial challenge to healthcare resources.~     For patients in rural communities, the opportunity to attend ambulatory care clinics is not~     always an option. Additionally, the opportunity for rural patients to receive quality care~     close to, or within their homes, is of great benefit as it reduces the need for extensive~     travel and the potential burden of clinical visits. The use of telehealth has been~     identified as an effective modality for chronic disease management and is actively promoted~     by national organizations as having great promise for health service delivery in rural~     areas. The Internet as a mode for healthcare delivery has numerous advantages: 1. it is~     ubiquitous with increasing access in all age groups, 2. it is inexpensive, 3. it facilitates~     both patient data transfer and patient feedback, thereby supporting patient self-management,~     4. it is scalable to large patient volumes, 5. it delivers health care directly to the~     patient and 6. it requires minimal set-up for patients with current Internet access.~      The investigators propose to develop and evaluate a multi-chronic disease management program~     delivered through the Internet (with telephone supports) focused on high-impact chronic~     diseases targeted to patients in rural communities.~      This study will consist of a single-blinded randomized controlled trial to investigate the~     efficacy of the iCDM in 318 patients with two or more of the target chronic diseases living~     in rural areas. Within this Aim, the investigators will be able to address the following~     research questions:~      Q1. What is the effect of iCDM on healthcare utilization and patient self-management~     outcomes? Q2. What is the long-term compliance to the iCDM? Q3. What is the level of patient~     and provider satisfaction?~   "
130884|NCT01342250|"~     Although liver transplantation provide a option to cure patients suffering with~     decompensated liver cirrhosis this condition, lack of donors, postoperative complications,~     especially rejection, and high cost limit its application. Bone marrow derived mesenchymal~     stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively~     rescued experimental liver failure and contributed to liver regeneration, which suggest the~     novel and promising therapeutic strategy In this study, the safety and efficacy of human~     umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with~     decompensated liver cirrhosis will be evaluated.~   "
130885|NCT01342237|"~     The investigators plan to improve event free survival rate and reduce treatment related~     toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating~     tandem high dose chemotherapy and autologous stem cell rescue.~   "
130888|NCT01342198|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet with and without coadministration of erythromycin and~     2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release~     tablet with and without coadministration of erythromycin.~   "
130889|NCT01342185|"~     The purpose of this study is to verify the effectiveness and safety of medical ozone therapy~     system in treatment of chronic hepatitis B.~   "
130890|NCT01342172|"~     The primary objectives of this study are (Phase 1) to determine in subjects with~     unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of~     lenalidomide that is well-tolerated when given in combination with gemcitabine plus~     cisplatin and (Phase 2) to study this recommended dose in subjects to evaluate~     progression-free survival at 1 year. The secondary objectives will be to determine the~     objective response rate to treatment, and the safety of combination therapy with~     gemcitabine, cisplatin and lenalidomide as well as to evaluate lenalidomide as maintenance~     treatment in subjects achieving objective response or stable disease.~   "
130891|NCT01342159|"~     One of the most frequent complications of diabetic retinopathy is diabetic macular edema.~     Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular~     therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and~     intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it~     was the purpose of the present study to compare these treatment effects~   "
130892|NCT01342146|"~     The purpose of the multicenter, randomized, open-label, controlled phase II study is to~     determine whether pegylated recombinant human growth hormone is effective in the treatment~     of children with growth hormone deficiency.~   "
130893|NCT01342133|"~     The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn~     infants using a non-invasive confocal microscopy device.~   "
130894|NCT01342120|"~     The purpose of this observational study is to study specific outcomes of interest in users~     of quetiapine compared with all other atypical antipsychotics and specifically olanzapine~     and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts,~     extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and~     stroke. This retrospective cohort study is based on population-based record linkage system~     (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.~   "
130895|NCT01342107|"~     The purpose of this study is to evaluate lens wettability of contact lenses when used with~     an investigational multi-purpose disinfecting solution.~   "
130896|NCT01342094|"~     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol~     ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary~     open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized,~     double-masked, parallel-group comparison study. Safety will be compared and evaluated as~     well.~   "
130897|NCT01342081|"~     DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost~     0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015%~     and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure)~     -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a~     multicenter, randomized, double-masked, parallel-group comparison study. Safety will be~     compared and evaluated as well.~   "
130898|NCT01342068|"~     Thoracic Outlet Syndrome (TOS) is a condition causing numbness, tingling and weakness in~     patient's upper limbs. Symptoms are due to compression and restriction of the nerves and~     blood vessels (neurovascular bundle) that extend from the neck into the upper limb exerted~     by a patient's various anatomical structures. Neurovascular bundle compression can result in~     decreased nerve conduction and blood flow through the arteries supplying structures~     downstream from the restricted site. These anatomical restrictions include tight scalene~     muscles in the neck, tightened pectorialis minor muscle in the chest and extra ribs growing~     from the C7 vertebra.~      TOS can be diagnosed by using special tests designed to re-elicit neurovascular bundle~     compression. Upon obtaining a positive test, the patient can undergo osteopathic~     manipulative treatments (OMT) to change the anatomical restrictions allowing for a decrease~     of symptoms and even eradication of the syndrome altogether.~      Although diagnosis and treatment of TOS is common in osteopathic medicine, the effectiveness~     of the diagnostic special tests and treatment has not been thoroughly investigated. This~     study aims to examine the effectiveness of the special tests (Adson's, Wright's~     hyperabduction and Halstead maneuver) in diagnosing a change in blood flow through the~     arteries of the upper arm compared to evaluation with Doppler ultrasound to measure blood~     flow while the tests are performed. Patients with positive tests will be treated with OMT~     including myofascial release, soft tissue, and articulation to relieve restricting~     structures. Upon completion of treatment, the special tests will be performed again along~     with the Doppler ultrasound to measure blood flow through blood vessels. Results then are~     analyzed statistically for significance of the ability correctly diagnose and treat TOS~     symptoms.~      Results from this study will contribute towards the validity of teaching special tests in~     osteopathic medical schools and allow for a non-invasive treatment protocol for patients~     with TOS.~   "
130899|NCT01342055|"~     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and~     Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.~   "
130900|NCT01342042|"~     This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes~     Mellitus will take part in the trial.~      Subjects will randomly enter into one of three groups, administration daily twice, the~     period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies~     in 1 d~ 8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.~   "
130901|NCT01342029|"~     This research study is designed to test the use of ranolazine in patients with angina (chest~     discomfort due to reduced blood supply to the heart) due to microvascular coronary~     dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is~     approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The~     FDA has approved this drug based on studies primarily on patients with chronic angina with~     major blockages of the arteries.~   "
130902|NCT01342016|"~     The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with~     leflunomide tablets in the treatment of lupus nephritis.~   "
130903|NCT01342003|"~     Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis~     C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This~     observational study was carried out on a large group of naïve HCV patients to evaluate~     difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment~     with peginterferon (Peg-IFN) plus ribavirin.~   "
130904|NCT01341990|"~     The purpose of the study is to evaluate the effect of an investigational multi-purpose~     disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture~     of silicone hydrogel contact lenses.~   "
130906|NCT01341964|"~     Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to~     prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets~     (sticky cells that circulate in the blood) from forming blood clots in the arteries~     supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin~     325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of~     clopidogrel in patients with a history of coronary artery disease who receive a 600mg~     loading dose of clopidogrel.~   "
130907|NCT01341951|"~     Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis~   "
130908|NCT01341938|"~     This research study will determine if using a combination of 4-mg nicotine lozenges,~     self-help materials, and/or telephone tobacco cessation counseling will help smokeless~     tobacco users stop using tobacco. The study will consist of three interventions:~        1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy,~          phone counseling, and self help materials~        2. Assisted Self-Help intervention - self-help materials and phone counseling without~          lozenges~        3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement~          therapy.~      Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the~     prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates~     at 6 months among ST users who are interested in achieving tobacco abstinence, compared to~     those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.~   "
130909|NCT01341925|"~     Childhood depression warrants treatment research; including pharmacological and~     psychotherapeutic interventions. A recent study found fluoxetine to be the only medication~     with empirical support for decreasing depression in children, but concerns about~     treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for~     use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted~     interest in alternative therapies including dietary supplements such as omega-3 fatty acids~     (Ω3).~      The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination~     to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with~     unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60~     participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect~     sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves~     over time, mediators and moderators, treatment response across an array of outcome~     variables, adherence to treatment, and side effects. This pilot study of Ω3, PEP, and~     combined treatment will provide evidence about whether a larger trial is feasible and~     justifiable.~   "
130910|NCT01341912|"~     The purpose of the study is to study the long-term efficacy, safety and tolerability of~     Human-cl rhFVIII in previously treated patients with severe hemophilia A.~   "
130911|NCT01341899|"~     Type 1 diabetes is an autoimmune disease and results from T cell autoimmunity mediated~     destruction of the majority of insulin-producing pancreatic β-cells. Hence,the development~     of new therapies to control T cell autoimmunity, and to preserve the remaining β-cell~     function will be of great significance in managing patients with type 1 diabetes~      Autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) has been tested~     for the treatment of patients with new onset of type 1 diabetes. This therapeutic strategy~     can result in exogenous insulin independence by destroying pathogenic memory T cells and~     preserving the remaining β-cell function.~      However, little is known about the efficacy of AHST in the dynamics of immunocompetent cell~     reconstitution and how the reconstituted immune system regulates β-cell specific antibody~     response. Furthermore, many Chinese patients at diagnosis of type 1 diabetes have progressed~     to develop diabetic ketoacidosis (DKA). Whether treatment with AHST could still achieve~     adequate glycemic control and preserve the β-cell function and what the factors are~     associated with the therapeutic efficacy have not been explored.~      This is a phase Ⅱ clinical trial in patients who have been diagnosed with type 1 diabetes~     within the previous 12 months.This study is to determine:~        -  The effects of autologous hematopoietic stem cell transplantation on the reconstitution~          of immune system~        -  β-cell preservation following stem cell transplantation~        -  The potential factors affecting efficacy of stem cell transplantation~        -  Whether this new therapy is safe.~   "
130912|NCT01341886|"~     Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery~     and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal~     which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid~     hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports~     have shown that metformin can induce TSH suppression without change in T3 and T4~     concentration. The purpose of this study was to prescribe metformin as additional drug to~     levothyroxin in order to decrease levothyroxine dosage.~   "
130913|NCT01341873|"~     This randomized clinical trial studies nursing intervention in supporting family caregivers~     (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare~     FCs support the recovery of the patients~   "
130914|NCT01341860|"~     A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the~     obese patients and the normal control will be performed to find genetic marker for obesity~   "
130915|NCT01341847|"~     Aim of the Study :~      This study will compare the colonoscopy examination between the air method (air~     insufflation) and water method (water infusion) in unsedated patients with indication~     (symptoms and signs based) of colonoscopy examination. This study is based on earlier study~     which showed that water method had better results in reducing abdominal pain, caecal~     intubation and patients willingness to repeat colonoscopy examination than air method.~      Background:~      Colonoscopy examination is an important method to examine and establish the diagnosis of~     various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the~     cecum and observe the caecal valve and/ or appendix orifice. This examination can be~     performed unsedated or under sedation (conscious sedation or deep sedation/general~     anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal~     discomfort or pain during examination that may make patient distress and hemodynamically~     unstable and possibly stoppage of the examination before reach the cecum, but the severity~     of abdominal symptoms is vary from patient to patient. Many efforts have been tried to~     reduce the abdominal discomfort during examination. This unsedated method with air~     insufflation is our hospital standard method for colonoscopy examination since early 1980s,~     and less than 1% of patients were colonoscopied with conscious or deep sedation. Our study~     showed the success rate of this standard unsedated method was about 82%. The advantage of~     this method is inexpensive (feasible for most of people in developing country like us),~     patient may be examined ambulatory without escort, may back to work as soon as the~     examination is finished. Studies showed that replace the air insufflation with water~     infusion into colon since the beginning of the examination increased the success rate of~     caecal intubation and reduced the abdominal pain symptoms during colonoscopy examination(1).~     Sedation or general anaesthesia may increase the success rate of colonoscopy examination but~     it is costly, and may increase the adverse event especially in the elderly or patients with~     significance cardiopulmonary problems.~      Research Design and Methods:~      Eligible patients in the hospital clinics or wards will be offered to follow unsedated~     colonoscopy examination. The principle investigator (PI) will explain the study, the~     colonoscopy procedure , the various symptoms that may be felt during examination, the~     possible adverse event and medical effort to prevent it. Patient who sign the informed~     consent will be included in the study.~      Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and~     colonoscopy will be performed by the principle investigator. Patient lie on the left lateral~     position with right hip and knee flexed and left leg straight. When the PI about to start~     the single-handed colonoscopy examination, the blinded observer open the sealed envelops~     with the code enclosed. A standard colonoscope will be inserted. Patient may be ordered to~     change the position and or abdominal compression may be applied by nurse to aid the~     colonoscope advancement. Oximetry, cardiac rhythm and blood pressure will be monitored~     during examination. Blinding will not be performed in this study because of the feeling of~     water or air effect inside the colon can be differentiated by the patient so that in our~     opinion it actually can not be blinded..The control method includes usual air insufflation~     during insertion and shortening maneuvers. The study method includes only water infusion~     (air pump is turned off) through the colonoscope during insertion since the scope is~     inserted into the anus until reach the cecum. Water will be infused as needed under~     endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The~     usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal~     examination and perform any other intervention, such as biopsy. Hypothesis testing: The~     unsedated colonoscopy with natural temperature water infusion minimize the pain symptoms~     than unsedated colonoscopy with usual air insufflation.~   "
130916|NCT01341834|"~     The purpose of this study is:~        1. To determine the optimal recommended phase II dose of two investigational study drugs,~          LBH589 and RAD001, given in combination in all solid tumors (With enrichment for~          EBV-Driven tumors).~        2. To determine the pharmacokinetic profile of RAD001 in combination with two schedules of~          LBH589.~        3. To assess the preliminary anti-tumor activity of RAD001 and LBH589.~      This study will also be exploring the hypothesis that HDACi and mTOR inhibitors abrogate the~     effects of key viral proteins, and switch the virus from a latent proliferative phase to a~     lytic phase. Immunologic correlates will also be examined to ascertain T-cell subpopulations~     and expression of HLA class molecules. DCE-MRI will be subsequently employed in dose~     expansion to examine antiangiogenic effects.~   "
130945|NCT01341457|"~     The primary objective of this study is to evaluate the safety and tolerability of LY2603618~     in combination with the standard dose of gemcitabine up to the global recommended dose of~     LY2603618 in Japanese patients with solid advanced or metastatic tumors.~   "
130917|NCT01341821|"~     This study is to discuss how different personalities of leaders and employees result in the~     effect of quality and efficiency in different organizational climate and also how the~     leadership style of different leaders affect the organizational climate. The investigators~     hope that this study will improve the key factor of quality and efficiency among leaders.~     Besides, the investigators want to provide the reference of quality control for the groups~     of healthcare quality in order to avoid unnecessary time and costs and achieve the goal of~     improvement quality.~   "
130918|NCT01341808|"~     The purpose of this study is to measure the immune response in 18-40 year old IBD patients~     after receiving the hepatitis A vaccine.~   "
130919|NCT01341795|"~     Type 2 diabetes have become a major global health problem. Currently, metformin is used as~     first-line therapy in combination with lifestyle changes, and sitagliptin can be added to~     metformin in case of insufficient glycemic control by metformin alone, and fixed-dose~     combination of sitagliptin and metformin is available.~      In clinical practice, inter-individual variations in response to sitagliptin and metformin~     treatment are commonly found, which may reflect inter-patient differences in disposition of~     these medications.~      Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and~     OCT2) and some functional variations of these transporters were reported. This study is~     designed to clarify the effect of these transporter variants on response to sitagliptin and~     metformin in type 2 DM patients.~   "
130920|NCT01341782|"~     This study is a comparison of the efficacy and safety of paricalcitol injection with~     maxacalcitol injection in adult Japanese chronic kidney disease patients receiving~     hemodialysis with secondary hyperparathyroidism. The main objective of this study is to~     demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone~     without clinically significant hypercalcemia, compared to maxacalcitol injection.~   "
130921|NCT01341769|"~     The purpose of this study is to assess the effects of added food ingredients, when baked~     into a snack food product, on glycaemic index of the product and glycaemic and insulinemic~     responses to the product in healthy adults.~   "
130922|NCT01341756|"~     The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which~     equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to~     historical controls.~   "
130923|NCT01341743|"~     The purpose of this study is to evaluate the efficacy and safety of generic entecavir~     monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate~     response to NUC therapy~   "
130924|NCT01341730|"~     This study is a prospective randomized clinical trial and to compare the antiinflammatory~     effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy~     in carotid arteries of stable and unstable angina patients by PET/CT.~   "
130925|NCT01341717|"~     The purpose of the study is to determine the efficacy and safety of sitaglipin in the~     treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using~     metformin and insulin.~   "
130926|NCT01341704|"~     Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective~     efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease~     occurring during a period beginning from 14 days after the 3rd immunization until 1 year~     after.~      The primary objective of this double-blind, randomized, controlled trial will be to assess~     the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in~     children aged 12-48 months against all clinical malaria episodes occurring during a period~     beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization,~     when administered according to the following schedule:- Primary administration: Three doses~     of administered 4 weeks apart~      Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the~     trial; and two doses, given exactly one year after the date corresponding to the third dose~     and the first boost given during Year 1~      Case definition for an episode of malaria is a febrile illness with axillary temperature of~     ≥ 37.5ºC with P. falciparum parasitemia ≥ 5000 per μL~   "
130927|NCT01341691|"~     To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a~     modified formulation (with or without an extender) added to the gum core, in comparison to~     matching placebo gums.~   "
130928|NCT01341678|"~     The purpose of this study is to describe the circadian rhythm of serum and salivary~     phosphorus in patients with chronic kidney disease and determine its' modification in~     response to changes in dietary phosphate load.~   "
130929|NCT01341665|"~     The aim of this study is to evaluate the different types of osmotic dysregulation in~     patients with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the~     pathophysiology of SIADH.~      These types will be characterized by measurement of AVP and copeptin while performing an~     osmotic stimulation with infusion of hypertonic saline.~   "
130930|NCT01341652|"~     The investigators are trying to find new methods to treat prostate cancer. The approach the~     investigators are taking is to try to enhance patients' own immune response against the~     cancer. In this study the investigators will be testing the effectiveness of a vaccine that~     may be able to help the body fight prostate cancer.~   "
130931|NCT01341639|"~     This study will determine whether subjects who receive V419 at 2, 3, 4, and 12 months of age~     have an acceptable immune response to the vaccine. The study will also determine whether the~     immune response to V419 is similar to that of subjects who receive a licensed vaccine~     control.~   "
130932|NCT01341626|"~     This study is a young adult follow-up of 166 females who originally participated in an RCT~     during adolescence due to their involvement in the juvenile justice system.~   "
130933|NCT01341613|"~     Background: It is becoming increasingly clear that individuals from all corners of the globe~     use probiotic dietary approaches to enhance health. More recently, probiotics have shown~     promise in treating a variety of disease states, due to improved strain selection, stability~     and delivery technologies.~      Objective: The purpose of this study is to determine the lipid lowering efficacy of a~     probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per~     day over 9 weeks, in subjects with hypercholesterolemia.~      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,~     multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out~     period, a 2-week run-in period and a 9 week treatment period.~   "
130934|NCT01341600|"~     Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and~     conditions caused by blood clots. Although clopidogrel works in many individuals, some~     people do not respond as well to this drug. The variation in treatment response may be~     linked to genetics. This study will examine the effects of clopidogrel in a population whose~     genes are well known in order to determine the role that genes play in the response to~     various clopidogrel maintenance doses.~   "
130935|NCT01341587|"~     Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to~     develop diabetes during his or her lifetime. Research has demonstrated that control of blood~     glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans~     diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The~     value of this approach is known to be limited by a high rate of patient non-compliance with~     BG testing, where patients test less often than prescribed. Increased communication between~     patient and care manager along with feedback has been shown to increase self monitoring of~     blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the~     current, episodic model of patient / care manager interaction and not available in existing~     BG meters given to diabetic patients.~      In this study, we propose to pilot test a cellular-embedded glucose meter. This device can~     transmit glucose readings directly over a cellular network to a care management server and~     then the patient will receive feedback on the screen of the glucose meter.~   "
130936|NCT01341574|"~     'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by~     right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients~     with this disorder neglect the contralesional side of space and/or their body. Their body~     axis is often shifted ipsilesionally. A specific disorder that can appear in neglect~     patients is 'contraversive pushing': a postural deviation to the neglected side because the~     patient pushes himself away from the ipsi- to the contralesional side.~      One of the most promising neglect interventions is prism adaptation (PA): inducing an~     optical shift of the visual field by means of prism glasses. This results in a modulation of~     brain areas involved in neglect and in an improvement of the neglect symptoms and postural~     deviation.~      Research questions:~        1. Which period is best suited to maximize therapeutic effects? In this respect the~          effects of early and delayed PA will be compared, regarding neglect-, postural and~          cerebral measures.~        2. Which factors lead to a less favorable treatment outcome or to therapy resistance for~          PA?~        3. Will the impact of PA be larger if postural factors are taken into account in the prism~          therapy?~   "
130937|NCT01341561|"~     The purpose of the study is to examine the relevance of biochemical markers (specific~     pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in~     patients with artificial ventilation.~   "
130938|NCT01341548|"~     The purpose of this study is to evaluate the safety and efficacy of intranasally~     administered civamide nasal solution in the prevention of cluster headaches during an~     episodic cluster headache period.~   "
130939|NCT01341535|"~     The investigators hypothesize that treatment adaptation to biological and anatomical~     changes, occurring during treatment, can increase the chance of cure at minimized or equal~     radiation-induced toxicity in head and neck cancer patients. This trial compares standard~     intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-FDG-PET/CT~     scans to adaptive 18F-FDG-PET-voxel intensity based IMRT or volumetric-modulated arc therapy~     (VMAT) using repetitive per-treatment planning 18F-FDG-PET/CT scans for head and neck~     cancer.~   "
130940|NCT01341522|"~     Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance~     Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to~     be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI~     examinations. A previous study has shown that MRI is indicated in 17% of all patients with~     pacemakers within 12 months of device placement , which demonstrates the need of practical,~     safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing~     system is developed by Sorin Group for safe use in the MRI environment. The new pacing~     system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This~     study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin~     Group Reply MR-conditional pacing system.~   "
130941|NCT01341509|"~     The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The~     purpose of this study is to evaluate the long-term outcome of surgical treatment by~     comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles~     tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of~     Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement,~     excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL~     transfer.~   "
130942|NCT01341496|"~     Background:~      - A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from~     a patient and then used to develop a vaccine. The vaccine will produce an immune system~     response to help destroy other cancer cells in the body. Researchers are studying ways to~     improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance~     that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been~     used safely in other clinical studies. But it has not been studied with certain tumor cell~     vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given~     along with cancer drug treatment, is a safe and effective way to slow or prevent tumor~     growth after tumor removal surgery.~      Objectives:~      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and~     drug therapy after tumor removal surgery.~      Eligibility:~      - People at least 18 years of age who have had tumor cell vaccines developed from cells~     taken from surgically removed tumors.~      Design:~        -  Patients will be screened with a physical examination, medical history, blood and urine~          tests, and imaging studies.~        -  Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily)~          for 7 days before the first vaccine dose.~        -  Patients will receive the tumor cell vaccine once a month for 6 months. They will~          continue to receive drug therapy throughout the vaccine treatment. Patients will be~          monitored with regular blood tests and imaging studies.~        -  After the first 6 months, patients who have an immune response to the vaccine will~          continue treatment with the vaccine and chemotherapy. They will also have regular blood~          tests and imaging studies. They will have this treatment for up to 24 months from the~          first vaccination or until they no longer have an immune response.~        -  Participants will have followup visits for up to 5 years after the first vaccination,~          or until the tumor returns.~   "
130943|NCT01341483|"~     The purpose of this study is to determine the proportion of men with known or suspected~     coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have~     angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as~     at least one ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular~     Analysis - QVA).~   "
130944|NCT01341470|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.~   "
130946|NCT01341444|"~     This study is being conducted to see how safe and effective the Prevena Incision Management~     System Prevena is when placed over a renal transplantation incision. Prevena provides~     negative pressure (suction) wound therapy. Prevena will be tested while applied during the~     time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small~     portable negative pressure device which consists of a therapy unit that delivers negative~     pressure. It also includes a dressing system that is intended for use over closed incisions~     after surgery.~      The intent of this study is to evaluate Prevena versus the standard care that a doctor would~     use normally after a kidney transplant.~   "
130947|NCT01341431|"~     The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of~     bee venom on motor symptoms of Parkinson's disease over a period of one year, also the~     potential effects of this treatment on disease progression compared to placebo (saline~     injections).~   "
130948|NCT01341418|"~     This study compares two techniques for the fixation of tibial fractures. The techniques are~     the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial~     intramedullary nailing. Null hypothesis: There is no difference in 1) residual~     post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4)~     trochlear changes in the patello-femoral cartilage between patients who are randomized to~     receive tibial nail insertion through either a suprapatellar nail entry portal or a standard~     patellar tendon approach.~   "
130949|NCT01341405|"~     This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two~     active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).~   "
130950|NCT01341392|"~     The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501~     and amlodipine after oral administration in healthy male volunteers.~   "
130951|NCT01341379|"~     Hyperammonemia, which can cause brain damage, occurs in many different kinds of inborn~     errors of metabolism. The investigators propose to determine if short-term (3 day) treatment~     with N-carbamylglutamate can diminish hyperammonemia by enhancing ureagenesis in these~     patients. The investigators propose here a short-term (3 day) trial. If it succeeds, the~     investigators would consider more extensive long-term studies of the drug.~   "
130952|NCT01341366|"~     Background:~      Laparoscopic colorectal surgery has been shown by randomized trials to be associated with~     better short-term clinical outcomes when compared with open surgery. However, in a~     traditional perioperative care setting, the reduction in hospital stay following~     laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been~     introduced in the West to optimize perioperative factors to reduce the~     physiological/psychological stress of open colorectal surgery. However, few studies have~     evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal~     surgery.~      Objective:~      To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing~     laparoscopic surgery for colorectal cancer with a traditional vs. a fast-track~     perioperative program.~      Design:~      Prospective randomized trial.~      Subjects:~      One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection~     of non-metastatic colonic and upper rectal cancer will be recruited.~      Interventions:~      Patients will be randomized to a traditional or a fast-track perioperative program.~      Outcome measures:~      Primary outcome: total postoperative hospital stay, including hospital stay of patients who~     are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters~     (including systemic cytokine response and cell-mediated immune function), morbidity and~     mortality, quality of life, and medical costs.~   "
130953|NCT01341353|"~     The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter~     ablation has increasingly been used over the last decades. The relative merits of each~     strategy have not been extensively studied. Our study was designed to determine if catheter~     ablation is a feasible option as first-line therapy for treating patients with symptomatic~     AF.~   "
130954|NCT01341340|"~     The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy~     of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with~     critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the~     tibial arteries.~   "
130955|NCT01341327|"~     The purpose of this study is to observe clinical courses for long-term in patients with~     unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary~     stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA~     stenosis in the real world daily practice.~   "
130956|NCT01341314|"~     Research has shown that early aggressive use of medicines may stop rheumatoid arthritis~     (RA)or slow its damage. The key to this is to find people with early symptoms which could be~     RA and have them get a diagnosis, treatment and follow-up.~      This study will recruit persons who've gone to the internet looking for information about~     their symptoms. After answering a screening survey, the person with possible symptoms will~     be linked to the study website for a more detailed symptom questionnaire.~      After completing that questionnaire the person will receive information about the second~     part of the study which includes an examination with a rheumatologist (arthritis doctor)and~     laboratory tests.~      Based on the joint examination and laboratory tests, the rheumatologist will tell the person~     the likelihood of having RA, and make recommendations and if needed a referral for care and~     treatment. Treatment is not a part of this study.~      This study will also compare the information on the subject's questionnaires to the doctor's~     joint examination and the laboratory tests with the hope of developing a simple inexpensive~     case finding questionnaire.~   "
130957|NCT01341301|"~     The purpose of this research study is to examine the survival of patients undergoing~     partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment~     approach, which has been developed specifically for patients who have evidence of their~     disease at the time of transplant. In this research study, a way of strengthening the~     response of the donor cells against the disease has been developed. Patients will undergo~     one additional day between the two steps of the transplant which may allow their donor's~     cells to fight the disease more effectively.~   "
130969|NCT01341132|"~     This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic~     resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma~     (Liver Cancer) comparison to multi-detector computed tomography (CT).~   "
130958|NCT01341275|"~     The aims of this study are to determine:~        1. the degree of immunity against hepatitis B,~        2. factors associated with immunity against hepatitis B,~        3. if the amount of antigen provided in a booster dose (used to measure the degree of~          immune memory) affects the body's response to the booster, and~        4. if the age at which the vaccination was initiated during infancy affects duration of~          protection against hepatitis B among adolescents 16-19 years of age born in the United~          States who were immunized against hepatitis B as infants. These data will be important~          to evaluate the potential need for a possible booster dose of hepatitis B vaccine among~          adolescents.~      Study subjects eligible for enrollment will:~        -  have blood drawn for baseline serologies~        -  receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug~          dose)~        -  have blood drawn again 14 days later to determine if the booster dose has engendered an~          anamnestic response (a response attributed to prior immunity rather than a new response~          to the vaccine)~      The primary hypothesis is that the majority of young people will exhibit immune memory for~     hepatitis B in response to a booster dose of vaccine.~   "
130959|NCT01341262|"~     The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory~     multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at~     investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double~     autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly~     diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then~     continued throughout the subsequent treatment phases until the day before the second~     autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis,~     are response rates to the different treatment phases (induction, first and second ASCT),~     best response whenever achieved, duration of response (DOR), time to progression (TTP),~     progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as~     evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes~     (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities~     and imaging features, as detected by 18F-FDG PET/CT.~   "
130960|NCT01341249|"~     The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the~     main component of DW224aa(Test drug) and DW224a(Reference drug).~   "
130961|NCT01341236|"~     This study aims at recruiting about twenty very low birth weight infants, either~     intrauterine growth restricted (IUGR) or NON-IUGR~      STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10~     children) and NON-IUGR infants (approximately 10 children).~      PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding~     in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).~      SECONDARY ENDPOINT:~        -  To compare if changes in the intestinal perfusion induced by feeding are different~          between IUGR and NON-IUGR infants;~        -  To compare growth and nutritional status of the 2 groups by randomized arm.~        -  To evaluate if changes of intestinal perfusion and oximetry induced by feeding are~          related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near~          Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the~          transitional period, between the 48th and 72nd hours of life, all infants' intestinal~          perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery~          will be executed.~        -  To test if changes in intestinal oximetry and perfusion can be reliable predictors of~          feeding intolerance (need of interruption of enteral feeding).~      DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including~     20 VLBW babies. Duration of the study: 24 months.~      INCLUSION CRITERIA~        -  Weight at birth ranging: 700 - 1501 grams;~        -  Gestational age up to 25 weeks and 6 days;~        -  Written informed consent from parents or guardians~      EXCLUSION CRITERIA~        -  Major congenital abnormality (severe heart or cerebral disease, chromosomopathies,~          severe renal malformations, any malformation or disease of the gastroenteric tract)~        -  Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal,~          cardiac or cerebral impairment, DIC)~        -  Pre-existing cutaneous disease not allowing the placement of the probe~   "
130962|NCT01341223|"~     The use of amniotic membrane in ophthalmic surgery has been shown to provide an alternative~     for corneal and conjunctival reconstruction in many clinically challenging situations. It~     has without doubt provided an option where previously none existed in some conditions.~     Nevertheless, it is has its limitations and is not universally successful for every~     indication. The indications for its use are ever increasing, often on anecdotal evidence. In~     some instances where it is successfully used, existing and at times simpler options are~     equally effective. The collective global experience with the membrane is now vast, and the~     field should now move into proper randomized controlled studies to evaluate its true~     potential.~   "
130963|NCT01341210|"~     This is a cross-sectional, observational and correlational survey study.This study is aim to~     survey the the knowledge, attitudes, and decision making towards clinical trials in cancer~     patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been~     experienced the treatment clinical trials' informed consent process. The research tool is a~     questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude~     toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4)~     Satisfaction with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The~     investigators expect the research outcome can provide some instructions to improve patients'~     autonomy, satisfaction of the decision making and communication process between patients and~     Medical professors whenever cancer patients participating in clinical trials.~   "
130964|NCT01341197|"~     Fecal occult blood test (FOBT) is a convenient tool for the screening of asymptomatic~     gastrointestinal (GI) bleeding while 「guaiac-based fecal occult test (G-FOBT) 」 is~     increasingly replaced by the use of an 「immunochemical-based test (I-FOBT) 」 that reacts~     with human globin, a protein that is digested by upper GI enzymes and is specific for~     detecting lower GI bleeding. However, in Taiwan, although the incidence of colorectal cancer~     is rapidly increasing, Helicobacter pylori-related upper GI pathologies remain highly~     prevalent, which may imply that mass screening solely based on I-FOBT could be insufficient~     as significant upper GI pathologies can be missed. Since I-FOBT dose not predict upper GI~     pathologies, the adjuncts of G-FOBT and H. pylori stool-antigen test (HpSA) may be a~     potential candidate to realize a pan-detecting assay based on stool samples in a population~     in which both lower and upper GI lesions are equally prevalent.~   "
130965|NCT01341184|"~     Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy~     volunteers~   "
130966|NCT01341171|"~     Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.~   "
130967|NCT01341158|"~     The current clinical trial shall clarify the efficacy, safety and biologic effects of~     neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional~     metastases of melanoma in stage IIIB/C.~   "
130968|NCT01341145|"~     The goal of this study is to determine if aerobic exercise or progressive muscle relaxation~     is associated with changes in cardiovascular health, brain function, and cognition.~   "
130975|NCT01341067|"~     The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has~     on subjects with type 2 diabetes. It is anticipated that patients using the device will~     obtain tighter control of their blood sugars resulting in measureable health benefits and~     improved confidence in their ability to manage their diabetes.~   "
130976|NCT01341054|"~     To determine the Chamomilla recutita solution dose needed to reduce the intensity and~     evolution time of oral mucositis in adult subjects submitted to HSCT.~   "
130977|NCT01341041|"~     This research is being done because the investigators are trying to examine the safety and~     effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are~     trying to see if this liquid has the ability to decrease infection rates and decrease the~     scarring effects from the healing process. In animal studies, CACD has been shown to~     decrease scar formation and decrease the risk of wound infections. CACD is also used for the~     treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA~     approved for this specific use, but it is FDA and USDA approved for reducing bacterial~     contamination on meat and food products for human consumption. In addition, an~     investigational drug (IND) application has been submitted to the FDA for this study. The FDA~     has approved the use of this solution for this study.~   "
130978|NCT01341028|"~     -  Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of~          restriction-malabsorption procedure and one of the most common operative procedures~          implemented.~        -  Over the last years increasing evidence suggests that the beneficial effects of~          bariatric operations might be related to the suppression of appetite caused by the~          release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like~          peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic~          hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and~          GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food~          intake.~        -  In the present study the investigators sought to evaluate the effects of the resection~          of the gastric fundus, the main source of ghrelin production, on the secretion of~          ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight~          loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.~   "
130979|NCT01341015|"~     Objectives:~      A lot of children who injure their ankles come to the emergency department for an~     evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is~     present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture~     and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the~     emergency departments are time consuming, often uncomfortable for the patient, and expose~     children to radiation, the long-term effects of which are not yet fully understand by~     doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that~     does not produce radiation. It was been shown to determine the presence of bone fracture in~     childrens' wrists and forearms just as well as X-rays do. In our study, the investigators~     would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures~     in children.~      Research Procedures:~      In our study, the investigators will ask the parents and children, who are scheduled to get~     an X-ray of their ankle in the emergency department, to examine their ankles with an~     ultrasound machine as well. Since the bedside ultrasound is not significantly~     time-consuming, does not require patients to remain still, and is readily available in the~     department, the procedure will be performed while kids are waiting to get an X-ray, getting~     registered, or awaiting further treatment. On the data collection form, the investigators~     will document the patients' names, birthdates, medical record numbers so that their X-ray~     results can be compared to the ultrasound results for the purpose of the study. The~     information will be stored in a secure cabinet in a locked office. The investigators will~     also document which side is injured, where the patient feels pain and what the ankle looks~     like to help perform the ultrasound. The results of both the ultrasound and X-ray will be~     documented for each patient.~   "
130980|NCT01341002|"~     The objective of this study is to estimate red blood cells (RBC) transfusion related to~     central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is~     performed in visceral, vascular and thoracic surgery units in the university hospital of~     Lille.~      One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old,~     patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold~     criteria for RBC transfusion according to the XXIIIth French Consensus Conference in~     critical care medicine recommendations.~      After randomisation, patients will be eligible to receive RBC according to their level of Hb~     in the standard group and according to the Hb and ScvO2 in the optimization group. Patients~     without any disease are transfused if their Hb level is below 7g/dL; patients older than 60~     years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac~     patients are transfused if their Hb level is 9g/dL or lower. In the second group,~     transfusion is performed if and only if the ScvO2 level is les than 70% when Hb is under the~     same threshold levels.~      The primary aim of the study is to compare the number of RBC units transfused by group~     (standard group or optimization group) over a period of 5 days counted from the first~     decision of transfusion taken post-operative. Considering the randomisation and considering~     the 50 % reduction of the decisions of transfusion in the group optimization, the absolute~     blood savings is estimated 25 % for the whole population. Secondary end points include the~     number of side effects associated with transfusion or when avoiding transfusion, length of~     hospital stay, and hospital mortality as well as major adverse events.~   "
130981|NCT01340989|"~     CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures.~     Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion~     through prevention of mesothelial hypoxia. We want to prove this concept in human and expand~     it to the use of full conditioning.~   "
130982|NCT01340976|"~     This study will evaluate the safety LY2787106 in participants with cancer and anemia. It~     will also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a~     dose escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given~     with and without iron supplementation.~   "
131013|NCT01340573|"~     This is a non-interventional study designed to evaluate the efficacy and safety of~     combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C~     (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and~     who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were~     enrolled into study.~   "
131014|NCT01340560|"~     Objective To evaluate the effect of local injury to the endometrium for implantation,~     pregnancy and live birth rates in ICSI -ET cycles with recurrent implantation failure.~      Design Randomized controlled clinical study. Setting A clinical will assist reproductive~     center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey.~      Population A group of 100 women, who failed to conceive during one or more cycles of IVF and~     embryo transfer (ET), will treat with a long protocol for controlled ovarian~     hyperstimulation.~      Methods The IVF treatment and ET will precede by repeated endometrial biopsies, in a~     randomly selected 50 of a total of 100 women.~   "
130983|NCT01340963|"~     The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by~     at least two distinct serological tests, and classified according to Los Andes~     classification in a long term follow-up aiming at identifying the predictive value of the~     signal-averaged electrocardiogram for cardiac death and ventricular tachycardia.~      All subjects admitted to the study were submitted to clinical history taking, physical~     examination, and noninvasive assessment, including blood pressure measurement, resting~     12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring,~     M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and~     frequency domains. Selected subjects were further submitted to treadmill stress test and~     coronary angiography to rule out coronary heart disease.~      Subjects were followed by non-investigational primary care assistance at three to six months~     scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation~     during follow-up were requested at discretion of primary evaluation. Adverse outcomes were~     ascertained by review of medical records and active contact to either study subjects or~     their relatives.~   "
130984|NCT01340950|"~     This primary aim of the project is to determine the association between antiretroviral~     therapy that better distributes into the central nervous system and prevention of~     HIV-associated neurocognitive impairment.~   "
130985|NCT01340937|"~     This study will determine whether three manufacturing lots of V419 (PR5I) induce similar~     immune responses to all of the antigens contained in V419 when given concomitantly with~     Prevnar13™ and RotaTeq™.~   "
130986|NCT01340924|"~     The overall objective of this research project is to study the impact of preventive~     practices on the T2D-related risk profile among women with and without prior GDM and their~     children exposed and unexposed to GDM.~   "
130987|NCT01340911|"~     The main purpose of the study is to see how safe SRT3025 (study drug) is when given at~     different doses. The study will also investigate how the study drug is taken up, metabolised~     (chemically broken down), distributed through the body and excreted. A further aim is to~     look at how taking the study drug after eating might change this process.~   "
130988|NCT01340898|"~     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine~     GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three~     different dose schedules.~   "
130989|NCT01340885|"~     The purpose of this study is to determine the relationship between attention and quality of~     life and how rivastigmine and atomoxetine alter attention in non-demented persons with~     Parkinson's disease (PD).~   "
130990|NCT01340872|"~     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,~     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with~     non-active ulcerative colitis (UC).~   "
130991|NCT01340859|"~     The broad objective of this research is to effectively utilize a unique window of~     opportunity during the hospitalization period following a recent suicide attempt to deliver~     a brief and targeted intervention for suicidal individuals.~   "
130992|NCT01340846|"~     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor~     that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part~     study (in 4 separate cohorts of subjects) designed to examine the interaction potential of~     GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or~     victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C:~     gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters~     of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain~     approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following~     completion of this study, subjects may continue dosing with GSK2118436 in the roll-over~     study, Protocol BRF114144.~   "
130993|NCT01340833|"~     GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor~     that is currently being developed for the treatment of BRAF mutation-positive tumors. This~     is an open-label, non-randomized study designed to determine the absolute bioavailability of~     an oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose~     of [14C]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will~     be obtained up to 72 hours post-dose. Safety assessments will be performed throughout the~     study. After completing all assessments, eligible subjects may transition to BRF114144, an~     open-label, rollover study of GSK2118436 to continue treatment.~   "
130994|NCT01340820|"~     The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in~     healthy, BCG-naïve adults.~   "
130995|NCT01340807|"~     Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are~     at risk of functional decline, joint degeneration, skin breakdown and further limb loss due~     to the forces placed on the contralateral limb through prosthetic ambulation. If specialized~     prosthetic gait training and proper use of the appropriate prosthetic foot can decrease~     forces on the intact limb, the long term health and quality of life of veterans with~     amputations could be substantially improved. We will address two key questions:~      Key Question 1: After receiving specialized gait training and a new prosthetic socket, will~     subjects demonstrate differences in gait symmetry and external mechanical work between the~     bionic and conventional prosthetic feet, while performing various functional activities.~      Key Question 2: Can external mechanical work be used as a clinically friendly measure to~     differentiate between prosthetic feet?~   "
130996|NCT01340794|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth~     and by blocking blood flow to the tumor.~   "
131015|NCT01340547|"~     This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2,~     and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will~     receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study~     treatment 24 hours later on Day 1.~      Time-matched, intensive ECG monitoring will occur during and following placebo and~     palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study~     analysis will be performed in a blinded fashion at a central ECG laboratory.~      Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be~     performed on Days 1 through 8 of Cycle 1.~   "
130997|NCT01340781|"~     The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is~     likely significantly higher than the general population as hospitalized patients carry a~     high prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that~     are commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not~     known, though there is limited data suggesting that the rate of OSA in hospitalized patients~     is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of~     OSA in patients referred for OSA evaluation while in-hospital. These studies reported~     frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an~     observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep~     disordered breathing in patients admitted with acutely decompensated heart failure, finding~     frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and~     75% (prospective study of 395 consecutive patients studied with portable monitors). However,~     all of these studies are limited by either study design (retrospective), small numbers,~     limited channel portable monitoring, or evaluations of highly select patient populations.~     Furthermore, none of these studies examined screening tools that may help to identify which~     patients are at risk for OSA and thus might require the more extensive and expensive~     objective testing.~      This study will test the following hypotheses:~        1. The prevalence of OSA in unselected hospitalized medical patients will be more than 50%~          of the study population.~           Specific Aim 1: To determine the prevalence of OSA in a group of unselected~          hospitalized medical patients by a combination of sleep symptoms and PSG performed~          while in-hospital.~        2. Screening tools will be able to accurately identify OSA in hospitalized medical~          patients.~      Specific Aim 2: To determine the accuracy of different screening questionnaires for the~     diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to~     that of a PSG performed while in-hospital.~   "
130998|NCT01340768|"~     This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment~     versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who~     regularly take an SU drug, and choose to fast during the month of Ramadan. The primary~     hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with~     or without metformin) compared to SU treatment (with or without metformin) results in a~     lower incidence of hypoglycemia in participants with T2DM.~   "
130999|NCT01340755|"~     Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at~     Massachusetts General Hospital and performed successfully to remove cancer of the lower~     rectum. Based on the outcomes, the research doctors believe that this investigational~     surgery may be as safe and effective as standard laparoscopic or open surgery performed to~     remove rectal cancer, may facilitate the operation and reduce the size of the abdominal~     incisions. In this research study, the investigators are looking to see if this~     investigational procedure is a safe and effective approach to remove rectal cancer of the~     mid and lower rectum.~   "
131000|NCT01340742|"~     Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.~      Ischemic preconditioning may have a protective effect. The purpose of this study is to find~     out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a~     protective effect.~   "
131001|NCT01340729|"~     The goal of this clinical research study is to find the highest tolerable dose of TPI 287~     that can be given to patients with metastatic melanoma. Researchers want to find out if TPI~     287 can control the disease. The safety of TPI 287 will also be studied.~   "
131002|NCT01340716|"~     This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood~     pressure, respiratory muscle strength and functional capacity in patients after recent acute~     myocardial infarction.~   "
131003|NCT01340703|"~     The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade~     or laser photocoagulation to the margin of the optic nerve, for the treatment of macular~     detachment associated with optic disc pits and to characterize retinal manifestations during~     treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with~     induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears~     to be an effective method of managing macular detachment due to optic disc pits. OCT~     scanning pre- and postoperatively suggests that peripapillary vitreous traction with the~     passage of fluid into the retina through the pit is the cause of the schisis-like separation~     seen in optic disc pit maculopathy.~   "
131004|NCT01340690|"~     This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in~     combination with zinc and magnesium, in children and adolescents diagnosed with Attention~     Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in~     agreement with the German Verordnung über Diätetische Lebensmittel (DiätV) and the~     corresponding European Directive 1999/21/EC. This objective is reached by performing a~     placebo-controlled supplementation study with a main efficacy criterion which is also being~     used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences~     between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating~     Scale, Parent Version IV (ADHDRS-IV).~   "
131005|NCT01340677|"~     The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of~     canagliflozin in healthy volunteers.~   "
131006|NCT01340664|"~     The purpose of this study is to evaluate the efficacy and safety of 2 different doses of~     canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are~     receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have~     inadequate glycemic (blood sugar) control.~   "
131007|NCT01340651|"~     The purpose of this study is to determine the safety and tolerability of ruxolitinib~     (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis~     (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).~   "
131008|NCT01340638|"~     The working hypothesis in this study is that the supraglottic device COOKGAS provides seal~     pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery,~     are sommeted to both interventions.~   "
131009|NCT01340625|"~     This study compared the relative bioavailability (rate and extent of absorption) of 0.4~     mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA~     with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott~     Company, Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy~     female adult volunteers administered under fasting conditions.~   "
131010|NCT01340612|"~     The STAT trial aims at comparing coiling versus coiling plus stenting in patients with~     aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous~     coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in~     addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared~     to coiling alone.~   "
131011|NCT01340599|"~     This randomized pilot phase II trial studies the side effects and how well defined green tea~     catechin extract works in treating patients with localized prostate cancer undergoing~     surgery. Defined green tea catechin extract contains ingredients that may prevent or slow~     the growth of certain cancers.~   "
131018|NCT01340508|"~     The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT)~     to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results~     in an improved pathological response rate from 8% (German trial) to 25%.~   "
131019|NCT01340495|"~     In this study we are looking at a type of radiation called proton radiation which is known~     to spare surrounding tissue and organs from radiation. The proton radiation will be~     delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated~     Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring~     treatment. This may reduce side effects that patients would normally experience with~     conventional radiation therapy or other means of delivering proton radiation therapy. In~     this study we are evaluating the effectiveness of using proton radiation delivered to reduce~     side effects association with radiation treatment.~   "
131020|NCT01340482|"~     The primary purpose of this study is to assess the safety and efficacy of repeated~     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia~     (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on~     bone mineral density and bone quality.~   "
131021|NCT01340469|"~     The purpose of this study is to determine whether oral probiotic supplementation could~     reduce the incidence of nosocomial infections in preterm infants.~   "
131022|NCT01340456|"~     The objectives of this study are:~        -  To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be~          used as a marker for induction of cytochrome P450 (CYP) 3A4.~        -  To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.~   "
131023|NCT01340443|"~     This observational study will evaluate the safety and efficacy of MabThera/Rituxan~     (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell~     lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient~     during the 6 months of induction treatment and for up to 3 years of follow-up.~   "
131024|NCT01340430|"~     The main purpose of this study is to confirm the high pathologic complete response rate~     after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent~     trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast~     cancer~   "
131025|NCT01340417|"~     The general goal of the present study is to examine the developmental changes caused by~     melatonin in preterm and term newborns.~      The major brain lesions associated with cerebral palsy and cognitive impairment in preterm~     infants are periventricular white matter damage (WMD). At the present time, despite major~     improvements in neonatal care, there are no established therapeutic regimens for the~     treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland;~     melatonin's neuroprotective action has been well documented in animal experimental models.~     Neuroprotection is believed to stem from its direct free radical scavenging, indirect~     antioxidant activities.~      Originality Several reports have described melatonin secretion in older children, but only a~     few have observed melatonin concentrations during the first year of life. Very little is~     known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin~     synthesis starts. Premature infants have a 3 months delay in the development of melatonin~     rhythmicity compared to full-term infants. One study found discordant data with decreasing~     melatonin value around term. The absence of longitudinal study and the low number of~     children included make the interpretation difficult of the secretion of melatonin at the~     newborn.~      Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml),~     compared to newborns at term (100pg/ml).~      Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care~     Units in Ile de France. Specific aim is to compare the developmental changes of melatonin in~     preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA~     +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:~        -  determine Melatonin creatinin excretion in preterm infants~        -  correlate between serum melatonin secretion and urinary melatonin and~          6-sulfatoxymelatonin excretion~        -  determine endogenous melatonin production in the human pineal~        -  correlate genetic variations between different levels of melatonin in premature infants~        -  assess clinical and neurological outcomes at term Clinical impact The present clinical~          project is part of a translational approach, expected data for infants born before 28~          weeks gestation is melatonin deficiency which should participate in determining the~          potential use of melatonin as a neuroprotectant in human preterm neonates.~   "
131026|NCT01340404|"~     The aim of this study is to demonstrate that cerebral velocities assessed by transcranial~     doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program~     A multicenter, national, non-randomized, prospective study of paired cohort will be~     conducted, with 2 groups of exposed (SCT) and non-exposed (TP) patients.~   "
131027|NCT01340391|"~     An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients,~     who has sustained a distal radius fracture in need of splinting are requested to participate~     in the study.~   "
131028|NCT01340378|"~     The primary goal of this investigation is to describe perioperative thrombin generation in~     neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the~     coagulation changes that precipitate postoperative shunt occlusion.~   "
131029|NCT01340365|"~     To evaluate the effects of Tai Chi—a mind-body exercise--on age-related loss of~     physiological complexity (using fractal and entropy based measures), and to understand the~     relationship between complexity, function and adaptability, we will conduct a two-arm~     prospective randomized clinical trial. Our overarching goal is to evaluate if six months of~     Tai Chi training, compared to a waitlist control receiving standard medical care, can~     enhance physiological complexity and adaptability in older Tai Chi-naïve adults. Secondary~     goals of the study are to characterize the relationship between complexity biomarkers,~     measures of function, and resilience. This pilot study will inform a future more definitive~     trial by providing information on recruitment and retention, compliance, dose-dependent~     effects, preliminary estimates of effect size, and the optimal biomarkers of complexity,~     function, and adaptive capacity.~   "
131030|NCT01340352|"~     Working hypothesis and aims:~      To investigate the association between cervical length in non-pregnant women, and the risk~     of premature birth.~      The participants will be recruited from the HaEmek Medical Center delivery room~     registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study~     group. The investigators will invite them 3 month or more after delivery to ultrasound~     examination of the cervical length. The participants in the control group will be the women~     whom term delivery follows by chronological manner to those in study group. Data of the~     cervucal length will be collected at the time of the examination.~   "
131031|NCT01340339|"~     The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the~     fluorescent reverse phototherapy in term and late preterm newborns.~   "
131042|NCT01340196|"~     The objective of this study is to evaluate the drug-drug interaction potential between BI~     201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV~     infection and/or Hepatitis B infection. Results of this study will serve as a basis for~     guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are~     coadministered.~   "
131032|NCT01340326|"~     Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan~     ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of~     those drugs used in previous clinical trials, therefore recommended in practical guidelines~     is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose~     is more efficacious compared to lower dose commonly used in clinical practice. In addition,~     the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has~     not been explored in the setting of post-MI remodeling.~      Therefore, the investigators evaluate whether submaximal dose, which are lower than those in~     major pivotal trials but typically used in clinical practice, can offer similar benefit in~     post-MI ventricular remodeling.~   "
131033|NCT01340313|"~     Caudal block is the world-widely used technique for an effective postoperative analgesia in~     children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually~     performed with a single-shot, proper dosage is required to achieve sufficient analgesic~     levels. Several clinical researches have been performed to assess the drug spread levels~     using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in~     children. In our previous study using fluoroscopy, we obtained the results that the~     established weight-based doses provided adequate block levels for each type of surgery.~      Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated~     information in real time during caudal or epidural block in children.~      The aim of this study is to evaluate the drug spread level with a weight-based doses using~     ultrasonography during caudal block in children and assess the reliability of the real time~     ultrasonography to determine the drug spread levels. After general anesthesia, the patient~     will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15%~     ropivacaine will be injected into the caudal space. The spread level will be step-wise~     evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25~     ml/kg, and 1.5 ml/kg.~   "
131034|NCT01340300|"~     Metformin is a medication that is commonly used in the treatment of diabetes. Recently small~     studies in cancer patients without diabetes suggest that metformin may benefit in lowering~     insulin levels. In those studies of patients with cancer but not diabetes, glucose (or~     sugar) levels in the blood are generally no lowered. Insulin and insulin-like growth factors~     affect the growth of cancer cells.~      This randomized study will compare different interventions; exercise, exercise and~     metformin, metformin alone, or a control arm. The investigators are not directly testing how~     either exercise or metformin affects your disease. The investigators are testing how they~     affect insulin levels in your body as well as other blood markers. The investigators believe~     that these blood tests may either be related to cancer recurrences or be an early sign of~     cancer recurrences and they are testing how both exercise and metformin may change those~     markers.~   "
131035|NCT01340287|"~     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable~     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption~     in midly hypercholesterolemic people not treated by statins.~   "
131036|NCT01340274|"~     Nova Scotia is experiencing a proliferation of gambling opportunities and their related~     gambling problems. The 2003 Nova Scotia Prevalence Study (2004) found that approximately~     50,000 adult Nova Scotians are at some risk for problem gambling and that approximately~     93,000 adult Nova Scotians are intimately connected to at least one person who has a~     gambling problem. The serious consequences of problem gambling are being felt by the~     Individuals engaging in Problem Gambling (IPGs), their Concerned Significant Others (CSOs)~     and their Communities.~      Very few IPGs access support services for their gambling problems. Some reports (National~     Gambling Impact Study Commission 1999) have found that only 3% of IPGs seek treatment. The~     Nova Scotia Gambling Prevalence Study (2004) states: Overall, 3.5% (26,000 adults) have~     been motivated to help someone else with a current gambling problem versus 0.5% (3,700~     adults) seeking assistance or information for a personal problem. While the CSOs of IPGs~     are seven times more likely to access professional addiction treatment the options for these~     individuals are limited and treatment programs often lack evidence in support of their~     effectiveness.~      The Community Reinforcement and Family Training (CRAFT) (Meyers & Wolfe 2004) approach~     provides significant benefits to the CSOs of persons abusing alcohol and other drugs. They~     benefits include: improvement in the quality of life of the CSOs; increasing the rate of~     substance abusers entering treatment; and decreased substance use. CRAFT empowers CSOs by~     providing tools to positively influence theirs and their significant other's behavior.~      The current study investigates the applicability and effectiveness of the CRAFT approach to~     the CSOs of IPGS.~      It is predicted that benefits to the CSOs receiving CRAFT will significantly surpass those~     receiving treatment as usual. The predicted benefits are: improvement in quality of life for~     the CSO; engagement of IPGs in treatment; and decreased gambling by the IPGs. With these~     achieved outcomes, this research will provide opportunity for earlier intervention, improved~     individual and family functioning and a reduction of the negative impact of problem gambling~     on the community.~   "
131037|NCT01340261|"~     The purpose of this study is to describe the demographic, medical, and~     psychological/behavioral characteristics of children and adolescent patients admitted to the~     Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be~     used to evaluate the clinical outcomes of patients admitted to the program as well as to~     examine the impact of various background factors on clinical outcomes.~   "
131038|NCT01340248|"~     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect~     on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy~     male volunteers.~   "
131039|NCT01340235|"~     Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to~     keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic~     blisters. Neonatal period and infancy are critical since this autonomic dominant affection~     usually improves with age. Cyclins seem to be efficient in some cases of EBS but are~     prohibited in children younger than 8 years old. Erythromycin can be a good alternative in~     this population due to its antibacterial and anti-inflammatory potential.~      The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease~     the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old~     after 3 months of treatment.~      Primary end point is the number of patients with decrease of blisters' number of at least~     20% after 3 months of treatment by oral erythromycin.~      It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3~     months. Follow up for each patient is 5 months. The duration of the study is 1 year.~   "
131040|NCT01340222|"~     The threat of preterm labour (PTL) is the first cause of hospitalization in the course of~     pregnancy. Its diagnostic is based on clinical examination with a positive predictive value~     of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been~     suggested by its secretion in the amniotic fluid during labour and by the increase in the~     expression of its RNA messengers in the peripheral maternal blood. We have also shown that~     the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery~     compared with those with caesarean delivery prior the onset of labour.~      OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal~     monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery~     occurring within 7 days post admission. Secondary: to (1) compare the predictive values of~     these new markers with those currently used, e.g. quantification of fœtal fibronectin and~     assessment of cervical length and effacement, (2) Compare the respective proportions of~     monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine~     if a correlation exists between the activation markers expressed by maternal monocyte and~     lymphocyte subpopulations and the neonatal outcomes of preterm infants.~      MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of~     amenorrhea and complicated PTL, will be prospectively included in the maternity wards of~     Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml~     blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not~     deliver within the first 7 days; finally, another blood sample will be drawn upon discharge.~     After delivery, foetal membranes will be collected to characterize and compare the various~     monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the~     study of the level of activation of blood and foetal membrane cells will be performed using~     flow cytometry technique with suitable markers. The main judgment criteria will be the~     percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations~     (inflammatory, residents or patrollers and intermediates, according to CD14, CD16,~     CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following~     markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B~     lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular~     IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3~     and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed~     using the Mann and Witney test or ANOVA, after verification of the conditions of~     application. The comparisons of percentages will be done using Chi-square Pearson tests and~     the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a~     stepwise descending analysis.~      TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte~     subpopulations in the maternal blood and in the foetal membranes might constitute an ~     immunological signature  of the labour and therefore validate the relevance of a predictive~     marker for clinicians.~      EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte~     subpopulations in the maternal blood will allow to better characterise the immunological~     mechanisms occurring at the start of premature labour and to identity predictive markers of~     the preterm delivery, to validate prospectively in order to optimize the management of PTL~   "
131041|NCT01340209|"~     The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over~     a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered~     by the Respimat inhaler will be examined on top of maintenance treatment with inhaled~     corticosteroid controller medication in patients with moderate to severe persistent asthma.~     Efficacy and safety will be assessed by measuring effects on lung function, effects on~     asthma exacerbations, effects on asthma control, and number of adverse events.~   "
131043|NCT01340183|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     the drug AZD5099 after intravenous administration of single doses in healthy volunteers. The~     results from this study will form the basis for decisions regarding the future development~     of AZD5099 as a novel antibiotic for the treatment of serious infections in humans.~   "
131044|NCT01340170|"~     The study objective is to establish that there is no statistical difference in marginal bone~     level change comparing a Standard drilling protocol with a Soft bone drilling protocol when~     using OsseoSpeed TX and immediate loading.~   "
131045|NCT01340144|"~     Analyze clinical data for a group of subjects implanted with a new surgical device designed~     to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that~     to a control group of subjects implanted with a TKA design known to have an incidence of~     patellar crepitus of approximately 5%.~   "
131046|NCT01340131|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828~     (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
131047|NCT01340118|"~     Abnormal lung function and high exhaled nitric oxide (FeNO) have been reported in~     asymptomatic patients with asthma. The investigators aimed to assess whether FeNO and~     FEF25-75 improve concurrently after treatment with inhaled corticosteroid (ICS) in patients~     with controlled asthma. Geometric mean (GM) FeNO and spirometric values in patients 8 to 16~     years of age who maintained asthma control without controller medication were compared with~     healthy controls and patients with uncontrolled asthma who were also not receiving~     controller medications. Patients with controlled asthma and high FeNO (> 25 ppb) were~     randomized to ICS treatment or to remain untreated. Changes in spirometric values and GM~     FeNO from baseline were evaluated after 6 weeks.~   "
131048|NCT01340105|"~     The purpose of this study is to compare microwave ablation using the Acculis Microwave~     Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien~     cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar~     carcinoma (HCC).~      The investigators hypothesize that microwave ablation can achieve a better complete ablation~     rate as compared to radiofrerquency ablation.~      A randomized comparative study is performed by randomly assigned participants to microwave~     ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed~     by the complete tumor ablation rate at 1 month, recurrence rate and survival time of~     participants. Safety of the procedures is also compared between the 2 treatment arms.~   "
131049|NCT01340092|"~     The purpose of this study is to see whether or not Family Navigators, who 1 ) help families~     after their child is diagnosed with autism and help them get autism specific services for~     their child 2) help families identify barriers to obtaining these services and 3) help~     families problem solve to overcome these barrier, are helpful to parents of a child newly~     diagnosed with an Autism Spectrum Disorder.~   "
131050|NCT01340079|"~     Comparison of 2 methods of delivery health education for African-American women with Type 2~     Diabetes. The two methods are: face to face education in small groups, as compared to~     delivering the same curriculum in the virtual world, Second Life.~   "
131051|NCT01340066|"~     The purpose of this study is to determine if a new drug treatment is effective for the~     treatment of symptoms of urinary incontinence.~   "
131052|NCT01340053|"~     This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of~     RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition~     of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery~     of screening procedures to determine eligibility for the trial.~      The study will consist of a 2-week treatment-free screening period, a 4-week blinded~     treatment period, and a 2-week treatment-free follow-up period.~   "
131053|NCT01340040|"~     The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in~     Japanese subjects with advanced solid tumours refractory to standard therapy or for which no~     standard therapy exists.~   "
131054|NCT01340027|"~     The purpose of this study is to examine how well two medicines in combination (solifenacin~     succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.~   "
131055|NCT01340014|"~     The purpose of this study was to assess patient preference regarding ocular comfort of~     AZARGA® compared to COSOPT® after one week instillation of each study medication.~   "
131056|NCT01340001|"~     Deep brain stimulation has been developed as a substitute for the classical lesioning~     methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases~     reports suggested that electrical stimulation of the cholinergic output of the Nucleus~     Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.~      The present study aims to assess the effect of bilateral electrical stimulation of the NBM~     on the mnesic performance [assessed by the sum of the three free recalls of the Free and~     Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate,~     Dementia with Lewy Bodies.~   "
131057|NCT01339988|"~     Long-term follow-up studies have demonstrated significant late toxicities of total body~     irradiation (TBI), which are most marked in children radiated at a young age. Growth~     failure, decline in cognitive function, and endocrine abnormalities have all been described.~     Good outcomes can be achieved with alkylating agents only as a preparative regimen. This~     plan will use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without~     antithymocyte globulin (ATG) to reduce the late toxicities of therapy that includes TBI.~   "
131058|NCT01339975|"~     Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a~     constant increase in its mortality and consequently requires an important involvement in~     translational research.~      The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers~     in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown~     anti-angiogenic and anti-tumor properties in experimental models and may be particularly~     interesting for prognostic and predictive purposes.~   "
131059|NCT01339962|"~     Non-interventional study. Data obtained by patient chart reviews.~      Retrospective analysis of progression free survival, time to treatment failure and overall~     survival in a national cohort of patients with metastatic renal cell carcinoma treated in~     Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity~     assessed by Charlson Comorbidity Index.~      The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus,~     Aldesleukin, Interferon-alfa-2b.~   "
131060|NCT01339949|"~     The objective of this study is to confirm the safety and to establish the effectiveness of~     low voltage external beam radiosurgery using the IRay System for the treatment of subjects~     with recurrent leakage secondary to neovascular Age-related Macular Degeneration (AMD) as~     determined by decreasing the number of Lucentis injections required during the first 12~     months of the study.~   "
131061|NCT01339936|"~     The main objectives of the investigation will be to assess the effect of the repeated usage~     of an investigational eye drop on the tear film characteristics of dry eye sufferers and~     demonstrate the benefit of this eye drops for dry eye sufferers.~   "
131062|NCT01339923|"~     The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when~     administered alone without routine infant vaccines to healthy infants in their first year of~     life according to different two and three dose immunization schedules, which are suitable to~     be adopted by various national programs. This study will also investigate antibody~     persistence post primary series and administration of a subsequent booster dose of rMenB+OMV~     NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of~     two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of~     age.~      This study will also evaluate the safety and immunogenicity of the concomitant~     administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according~     to a 3, 5 and 12-month schedule.~   "
131063|NCT01339910|"~     The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic~     hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC)~     versus reduced intensity conditioning (RIC) regimens.~   "
131064|NCT01339897|"~     This Phase 1 study will evaluate multiple doses across a range that has been found to be~     effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended~     to provide evidence of the tolerability of multiple doses as well as provide information on~     the Pharmacokinetic (PK) and metabolism of N6022 in humans.~   "
131065|NCT01339884|"~     The purpose of this study is to determine the effect of two doses of resveratrol taken for a~     12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will~     also measure the effect of resveratrol on markers of oxidative stress, clinical measures of~     ataxia, and cardiac parameters.~   "
131066|NCT01339871|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of pazopanib and vorinostat that can be given to patients with advanced cancer.~     The safety of the drug combination will also be studied.~   "
131067|NCT01339858|"~     The primary objective of this study is to determine if NAC, added to existing antipsychotic~     treatment, is superior to placebo for cortical erosion in patients with early stage~     psychosis. The primary hypothesis is that there will be significantly less cortical erosion~     as measured by cortical thickness, cortical volume and cortical white matter density~     (assessed by DTI) in patients treated for 12 months with NAC as compared to those treated~     with placebo. The secondary objectives of this study are to determine if 12 months of NAC~     add-on treatment is superior to placebo for fMRI determined working memory and semantic~     memory tasks, cortical MR spectroscopy measures (glutathione, N-acetylaspartate, and~     glutamine/glutamate levels), electrophysiologically determined attention measures (e.g.,~     mismatch negativity, P300), symptoms, functional measures and cognitive functioning.~   "
131068|NCT01339845|"~     The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a~     mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high~     incidence urban area. This study will also evaluate the feasibility of adding a household~     hand washing and safe drinking water promotion intervention to a cholera vaccine program and~     the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio~     cholerae.~   "
131069|NCT01339832|"~     This observational study is a follow-up study of protocol ML18280. Survival data of patients~     who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV~     of ML18270.~   "
131070|NCT01339819|"~     The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet~     aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with~     either agent.~   "
131071|NCT01339806|"~     The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in~     OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24~     months post injury) cognitive complaints. This is a prospective, randomized, control~     treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of~     mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive~     complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service~     at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the~     treatment trial will be randomly assigned to one of four, 6-week treatment arms of the~     study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks~     following the initiation of the study. The total number of patients to be studied is 160~     (maximum), which is approximately 20 patients per month.~   "
131072|NCT01339793|"~     In recent years, many hospitals have progressively perceived the importance of corporate~     social responsibility (CSR). More and more hospital superintendents thus have realized that~     they should have a CSR strategy to deal with various stakeholders. Hospital, as a health~     care sector, is a labor-intensive industry. The management of hospitals should view its~     employees as salient stakeholders as well as a sort of precious asset by which hospital can~     possess a unique competition advantage in the operation. It is therefore important for~     superintendent to understand an employee's perspective on CSR and its impact on employees'~     work attitudes and organizational performance.~   "
131087|NCT01339598|"~     This study aims to investigate the potential for Transcranial Direct Current Stimulation~     (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the~     effect of active or sham tDCS (placebo control) during the performance of two cognitive~     tasks. The investigators hypothesize that task performance will be improved with active~     relative to sham tDCS.~   "
131088|NCT01339585|"~     This project will investigate a novel strategy for enhancing cognitive training (CT).~     Specifically, the investigators aim to combine a non-invasive form of brain stimulation~     (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be~     administered either before or during CT.~   "
131073|NCT01339780|"~     Prostate and breast cancer continues to be the most common cancer among men and women,~     respectively. The exact assessment of the cancer spread with detection of possible bone~     metastasis is crucial for treatment decision. In the current study 50 patients with prostate~     cancer and 50 patients with breast cancer at high risk for bone metastases or with know~     metastatic disease will be studied with multiple imaging modalities. Patients will be~     recruited from the Department of Oncology, Turku University Hospital. Planar bone~     scintigraphy (BS), single photon emission computed tomography combined with low-dose~     computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed~     tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients.~     The primary objective is to determine the diagnostic accuracy of the four imaging~     modalities. The secondary goal is to calculate the sensitivities and specificities of the~     four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the~     results of this study an optimal imaging protocol for detection of prostate and breast~     cancer bone metastasis will be developed and validated.~   "
131074|NCT01339767|"~     The purpose of this study is to learn more about risk factors for autism by studying the~     behavior and brain functioning of toddlers with early communication delays and typically~     developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at~     18 months, limited vocalizations at 12 months) and typically developing toddlers may be~     eligible to participate. This study will be conducted at the NIH Clinical Center in~     Bethesda, Maryland. There will be an initial screening evaluation that will include~     behavioral assessment. Eligible participants will then complete a baseline visit that~     includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure~     brain electrical activity, and an MRI scan. Follow-up visits that include behavioral~     assessment will occur every 6-12 months, depending on age at study entry. The final study~     visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG~     study, and MRI. There is no cost for participation. Compensation will be provided. To find~     out if your child qualifies or for more information, please call 301-451-7822 (TTY:~     1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health,~     National Institutes of Health, Department of Health & Human Services....~   "
131075|NCT01339754|"~     RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients~     with metastatic pancreatic cancer after first-line chemotherapy.~   "
131076|NCT01339741|"~     The purpose of this research is to study whether vitamin D supplement can improve clinical~     outcome (PASI score) in psoriasis vulgaris with vitamin D insufficiency and deficiency.~   "
131077|NCT01339728|"~     The purpose of the present study was to investigate the effect of far-infrared ray at CV12~     acupoints area on the skin temperature and skin blood flow of palm central area of right~     hand, and the correlation between them.~   "
131078|NCT01339715|"~     The purpose of the study was to investigate the changes of Ryodoraku value at 12 source~     acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination~     applied to CV12 acupoint.~   "
131079|NCT01339702|"~     Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma~     Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in~     the prehospital EMS systems throughout the state of Arizona.~   "
131080|NCT01339689|"~     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,~     15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress~     Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either~     ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will~     continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of~     ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment~     using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to~     evaluate the safety and tolerability of ganaxolone in the PTSD population.~   "
131081|NCT01339676|"~     This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase~     4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to~     subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis~     patients.~   "
131082|NCT01339663|"~     This phase I trial studies the side effects and best dose of autologous T-antigen-presenting~     cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and~     cyclophosphamide in treating patients with metastatic melanoma. Aldesleukin may stimulate~     lymphocytes, such as CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in~     the laboratory may help the lymphocytes kill more tumor cells when they are put back in the~     body. Vaccines made from melanoma antigen may help the body build an effective immune~     response to kill tumor cells and may boost the effect of the CTL. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving T-APC vaccine~     after CTL and cyclophosphamide may be an effective treatment for melanoma~   "
131083|NCT01339650|"~     This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and~     pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or~     BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary~     peritoneal cancer.~   "
131084|NCT01339637|"~     The overall objective of this study is to increase the number of dark skin tone individuals~     in the data set and evaluate if this increase in dark skin tone data has an impact on the~     accuracy of the SCOUT DS Diabetes Risk Score (DRS).~   "
131085|NCT01339624|"~     The purpose of this study is to determine whether nasal fentanyl is effective in the~     treatment of renal colic in adults in emergency department.~   "
131086|NCT01339611|"~     The aim of the study is to test if patients under oral anticoagulation therapy who are going~     to participate in the education program will have better Health-related quality of life,~     higher rate in pharmacological treatment adherence and better self efficacy to manage the~     treatment.~   "
131089|NCT01339572|"~     This protocol will investigate the effectiveness of plerixafor in the up-front setting in~     avoiding a second round of mobilization and whether this translates into a clinical and~     economic benefit.~   "
131091|NCT01339546|"~     The rationale for this study is to assess the change in ambulatory care visit rates for~     acute otitis media between the period before (2001-2009) and after the introduction of the~     13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5~     years old in the United States.~   "
131092|NCT01339533|"~     APRV mode of ventilation will result in an improved partial pressure of arterial~     oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub~     hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU~     stay in patients with respiratory failure. APRV will be associated with a reduction in the~     amount of vasoactive medication used for blood pressure support in patients with respiratory~     failure.~   "
131093|NCT01339520|"~     The purpose of this study is to see if the use of a diabetic scorecard during clinic visits~     can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and~     amount of exercise in adults over age 40 with uncontrolled Type II diabetes.~   "
131094|NCT01339507|"~     The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after~     instillation.~   "
131095|NCT01339494|"~     Introduction~      Baylor College of Medicine and Texas Children's Hospital are recruiting individuals with~     MELAS syndrome for a clinical study. MELAS syndrome is a mitochondrial disease; patients~     with this disease have muscle weakness and often develop brain strokes, where blood does not~     flow normally to different parts of the brain. It is believed that these strokes could be~     due to decreased production of nitric oxide, a naturally occurring compound important for~     normal blood vessel function. Nitric oxide is made from arginine and citrulline that are~     normally found in our bodies.~      What is the purpose of this study? The purpose of this study is to measure nitric oxide in~     individuals with MELAS and see if giving arginine or citrulline will increase the formation~     of nitric oxide. Nitric oxide is thought to be helpful in preventing strokes. Therefore, if~     arginine and/or citrulline are shown to increase the formation of nitric oxide, they could~     be used to prevent or treat the strokes in patients with MELAS syndrome.~   "
131096|NCT01339481|"~     The purpose of this study is to characterize CD86 receptor occupancy in subjects with~     rheumatoid arthritis (RA) receiving abatacept.~   "
131097|NCT01339468|"~     The purpose of this study is to investigate and compare the pharmacokinetic parameters of~     tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.~   "
131098|NCT01339455|"~     Neuromyelitis Optica (NMO) is a demyelinating and degenerative disorder of the CNS affecting~     vision and spinal cord function. This disease is rare compared to Multiple Sclerosis (MS),~     but it is devastating and often leads to accumulating disability with a 5 year-mortality of~     approximately 30%. Survivors are typically left with severe morbidity secondary to~     blindness, quadriparesis and respiratory failure. No agent has been found to be highly~     effective in halting disease activity. Based on recent outcomes of stem cell transplant~     trials and reports in autoimmune diseases including MS, and based on the mechanisms of NMO,~     we anticipate that stem cell transplantation may provide lasting disease stability for NMO~     patients. The hypothesis of the present trial is that autologous hematopoetic stem cell~     transplantation in patients with NMO will provide lasting benefit in relapse prevention.~     Specifically, we anticipate a 50% reduction in the proportion of patients experiencing~     relapse over a three year period. We will be following patients for a total of five years~     after transplantation.~   "
131099|NCT01339442|"~     This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given~     together with fulvestrant in treating postmenopausal patients with estrogen~     receptor-positive (ER+) stage IV breast cancer. The toxicity profile of this combination~     therapy will also be described. Inhibition of PI3K by BKM120 may enhance programmed cell~     death (apoptosis) in estrogen receptor positive (ER+) breast cancer cells. Giving~     fulvestrant together with BKM 120 may enhance this apoptotic effect, providing a novel~     therapeutic strategy for patients with metastatic ER+ breast cancer.~   "
131100|NCT01339429|"~     The objective of this study is to implement a simplified Negative Pressure Wound Therapy~     (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT~     device is at least equivalent to commercially available NPWT devices. Therefore, the~     specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT~     device and 2. the adverse events associated with the sNPWT device.~   "
131101|NCT01339416|"~     Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins~     University, University of North Carolina and Vanderbilt University will be followed in the~     routine clinical care to estimate the rates of prespecified clinical events in this~     population.~   "
131102|NCT01339403|"~     Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry~     wil be followed in the usual clinical care to estimate the rates of specified clinical~     events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV~     Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be~     compared with the rates of these events in patients in the Kaiser Permanente database who~     are not infected with HIV.~   "
131103|NCT01339390|"~     Obesity has been linked to several serious medical conditions, including high blood~     pressure, diabetes, and poor cholesterol levels. For this reason, obesity is likely the most~     important single contributor to cardiovascular mortality in the United States. Fortunately,~     intensive weight management programs are an effective treatment for obesity. Such programs~     help people lose weight and improve their measures of cardiac risk. In response to the~     growing numbers of obese Veterans being treated at Veterans Health Administration (VHA)~     facilities, the VHA developed the MOVE! Program. Veterans who commit to MOVE! and~     participate actively do lose weight. Unfortunately, MOVE!, like other weight management~     programs, requires its participants to attend classes and to exercise, often at locations~     and times that are inconvenient. The investigators propose to make it easier for eligible~     patients at the Zablocki Veterans Affairs Medical Center (ZVAMC) to participate by offering~     MOVE-style classes and exercise groups at a variety of locations, days, and times. The~     investigators' program-MOVE OUT-may provide a model for VHA to use nationwide.~   "
131218|NCT01337752|"~     The study will evaluate the effects of BHQ880 in patients with previously untreated multiple~     myeloma and renal insufficiency who are not considered candidates for bisphosphonate~     therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in~     combination with bortezomib and dexamethasone, compared to placebo administered with the~     combination on the time to first Skeletal Related Event (SRE) on study.~   "
131104|NCT01339377|"~     To evaluate the safety and effectiveness of the AO-1000 device to treat and relieve the pain~     of symptomatic subjects with contained herniated discs. This single-arm pilot study will be~     used as a go vs. no-go decision on performing a randomized-controlled trial.~      The study's primary effectiveness objective is to demonstrate that the patient's~     functionality (based on Oswestry Disability Index scores) has improved from baseline at one~     month. The study's primary safety objective is to demonstrate that serious device/procedure~     related adverse events and subsequent surgical interventions are no greater than those in a~     literature control of other percutaneous disc decompression procedures at discharge, 1~     month, 6 months, and 12 months post-treatment.~      Secondary objectives are to demonstrate procedural success and improvement in the pain and~     function of the subjects at 1, 6, and 12 months using the VAS and ODI scales as well as~     tracking analgesic medication use. Pain and function scores for each follow-up time will be~     compared to the baseline scores.~   "
131105|NCT01339364|"~     This study is a three-arm randomized controlled trial to evaluate the effects of 1-day~     continuing educational meetings for community pharmacists with three distinct educational~     methods: 1) Didactic lecture 2) Didactic lecture plus case discussion in a large group 3)~     Didactic lecture plus small group education with simulated patient~      Knowledge and attitude of the participants would be measured as the study outcome in three~     periods: pre-education, post-education and 1 month after the meetings.~   "
131106|NCT01339351|"~     African American women with breast cancer have decreased quality of life (and mood when~     compared to European American. Research has not examined the effectiveness of therapeutic~     group for African American women with breast cancer even though positive effects are well~     established for Caucasians. The aims of the randomized clinical trial are to determine the~     effectiveness of TG by teleconference for African American women with breast cancer and what~     factors may impact on the intervention. The primary hypothesis is that participants in the~     intervention group will have significantly greater cancer knowledge, less fear, less~     isolation, better social connection, better mood, and better QOL when compared to a control~     group receiving usual psychosocial care. Two hundred forty African American women with~     breast cancer will be recruited. Intervention participants attend eight weekly 90 minute~     sessions by teleconference and two follow-up boosters. Each culturally appropriate session~     contains the story, information and group processes of connection, commonality and~     catharsis. Information focuses on increasing self care and stress management knowledge while~     countering myths and taboos. Story capitalizes on African American oral traditions by~     discussing coping parables. Group processes provide an alternative source of social support~     and opportunities to express feelings. Control group subjects receive standard psychosocial~     care (the use of any support programs or services locally or nationally. Testing will occur~     at baseline, after 10 group sessions and 16 weeks post baseline. The study findings are~     expected to inform about the effectiveness of therapeutic groups in African American women~     with breast cancer and lay the groundwork for exploring if reducing disparities in~     psychosocial care have a health benefit.~   "
131107|NCT01339338|"~     The purpose of this study is to compare the use of warm-media with cold-media in performing~     hysterosalpingography (HSG).~   "
131108|NCT01339325|"~     The aim of this study is to assess possible differences between the LESS approach and the~     standard laparoscopic approach to cholecystectomy. In particular, the Postoperative Quality~     of Life (QoL) will be investigated by analyzing the followings: length of hospital stay~     (LoS), postoperative pain, cosmetics and the results of SF 36 questionnaire. Furthermore,~     operative time, conversion to standard LC rate, difficulty of exposure, difficulty of~     dissection, and complication rate will be compared.~   "
131109|NCT01339312|"~     This study is designed to gather safety and immunogenicity data with Purified Vero Rabies~     Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule,~     using the Essen regimen, across different populations.~      Primary Objective:~        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab~          vaccine, in terms of proportion of participants with a rabies virus neutralizing~          antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in~          participants aged 10 to 17 years and in participants aged 18 years and over.~      Secondary Objectives:~        -  To assess the clinical safety of VRVg after each vaccination when administered in a~          post-exposure prophylaxis vaccination schedule in each respective age group and overall~        -  To describe the immune response induced by VRVg before the fourth vaccination and 14~          days after the last vaccination in each respective age groups and overall.~   "
131110|NCT01339299|"~     The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study~     to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human~     chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in~     normogonadotrophic women.~   "
131111|NCT01339286|"~     Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with~     the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements,~     professions and social livings are impaired. Comorbid antisocial behavior, substance abuse~     and delinquency burden family and society. Stimulants used to be the first line drug. But~     the medication compliance is poor because of strict drug administration. Atomoxetine is a~     new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect~     slowly, the drug responses differ significantly, and side effects interfere compliance.~     Since genetic factors is the most important cause for different drug responses, this project~     studies candidate genes potentially associated with atomoxetine medication, with the aim to~     find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts~     cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be~     collected. The rapid genotyping of large sample depends on high-through laboratory. New~     statistic method is to be used to improve the sensitivity of the target gene detection.~     There has been no such report in country and overseas. This project will provide basic~     information for forecasting drug response, improving clinical effects, tolerance and~     long-term compliance.~   "
131259|NCT01337206|"~     The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign~     esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to~     standard therapy, (2) achalasia refractory to standard therapy.~   "
131112|NCT01339273|"~     Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when~     compared to open large bowel resection, but is still associated with a significant amount of~     pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving~     varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs),~     regional analgesia and oral or parenteral opioids. While epidural analgesia is considered~     the gold standard for open colo-rectal procedures it can be associated with significant~     complications and may delay hospital discharge in laparoscopic procedures. Opioids are~     associated with an increased incidence of nausea, vomiting and sedation and reduced bowel~     motility which can also prolong recovery.~      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain~     sensation from the abdominal wall and provides effective and safe analgesia with minimal~     systemic side effects. Their perceived benefits are thought to relate to reduced opioid~     consumption and therefore reduced opioid side effects. The investigators believe ultrasound~     guided TAP blocks will reduce pain and morphine consumption with a resultant improved~     patient satisfaction, earlier return of bowel function and earlier hospital discharge.~      The key research question the investigators are trying to answer is whether TAP block~     provide better pain relief than local anaesthetic infiltration of the laparoscopic port~     sites. Both techniques are currently being used in our hospital and a retrospective audit~     demonstrated better analgesia and lower consumption of morphine in the TAP block group.The~     differences were not statistically significant as the number patients in the audit were not~     large enough.The investigators are hoping that this study will demonstrate that the~     difference is real by recruiting the necessary number of patients into each group (36 per~     group)~   "
131113|NCT01339260|"~     NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose~     of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given~     with oral dexamethasone. The objective of the study is to demonstrate that netupitant and~     palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting~     induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles~     of chemotherapy.~   "
131114|NCT01339247|"~     The study is prospective, open, randomized, crossover in steady state and the volunteers~     received multiple doses of the test drug and the reference drug (two periods of drug~     administration after standardized meals).~   "
131115|NCT01339234|"~     This study is a pilot trial to evaluate the effects of supported treadmill walking in~     patients with primary progressive multiple sclerosis (MS) on functional and psychosocial~     outcomes. Patients will exercise three times per week over the course of 6 months and will~     be evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will~     also be conducted 12 weeks after participants have stopped exercising to determined the~     lasting effects of the intervention.~      The investigators hypothesize that supported treadmill walking will be effective at~     improving physical physical function and psychosocial outcomes in patients with primary~     progressive MS.~   "
131116|NCT01339221|"~     The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian~     children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic~     drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts~     (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium~     population after the introduction of Rotarix™. The study will also detect if there is any~     alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine~     strain is still efficacious in preventing rotavirus gastroenteritis.~   "
131117|NCT01339208|"~     The purpose of this study is to evaluate the feasibility and clinical efficacy of an~     innovative care model that combines Telemedicine consultations, educator therapeutic~     management and diabetes education to empower patients to be in greater control of their own~     diabetes care for improvements in diabetes outcomes.~   "
131118|NCT01339195|"~     Projections from epidemiological studies suggest that, among the Western adult population,~     one in three will present a cerebrovascular accident (stroke), severe cognitive disorders,~     or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed~     by a North America working group which are under validation. It is essential to adapt these~     standard for French-speaking population, and especially to define cutoff scores of the~     cognitive battery to determine cognitive deficit.~      The investigators propose a study coordinated by the University-Hospital of Amiens for~     french speaking centers. This study will investigate this battery with 906 controls to~     define the standards and 302 stroke affected patients to define the frequency and cognitive~     mechanisms. This step is essential for people to benefit from these new standards.~   "
131119|NCT01339182|"~     This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics~     of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific~     data for the design and conduct of subsequent studies.~   "
131120|NCT01339169|"~     The aim of the study is to find out if the experimental medicine, YF476, can make gastric~     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur~     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the~     acid-producing cells in the lining of the stomach can't make acid. Acid production is~     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.~     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin~     in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow~     and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually~     benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids~     have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric~     carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of~     which is a mini video camera, which enables the user to inspect the lining of the stomach~     and a 'snare' to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor~     antagonist (blocks the effects of gastrin), so it's a potential new medical treatment for~     gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily~     for up to 12 weeks. If they benefit from that treatment, they may take YF476 daily for up to~     another 52 weeks. They'll make several outpatient visits for tests, including checks on the~     safety of YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the~     gastric carcinoids will be measured and biopsies taken for laboratory tests.~   "
131121|NCT01339156|"~     P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a~     NO moiety is intended for the treatment of pain and inflammation. The rationale behind~     development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory~     activity of naproxen and enhance GI safety by virtue of release of NO besides with no major~     effect on blood pressure on long-term administration.~   "
131122|NCT01339143|"~     The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to~     oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that~     was inadequately controlled by metformin.~   "
131123|NCT01339130|"~     Empathy, defined as the ability to understand others emotions, is a fundamental concept in~     social interactions. It is a psychological phenomenon involving various separable components~     : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the~     perspective of other people. Several neurological diseases with behavioral disorders may~     lead to impaired processing of social and/or emotional informations. These pathologies are~     likely to induce a lack of empathy that may result from impairments at different levels.~      The objective is simply to study how others' emotions are understood and how this allows for~     regulation of personal behavior. This study is being carried out among patients seen for~     various health problems and who can make behavior changes. This study could help to~     understand some neurological diseases and thereby to identify them earlier and/or to better~     differentiate them.~   "
131124|NCT01339117|"~     The purpose of this study is to determine whether a specific diet may help children with~     irritable bowel syndrome.~   "
131125|NCT01339104|"~     Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and~     anti-tumor activity in patients with advanced solid tumors~   "
131126|NCT01339091|"~     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)~     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral~     linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial~     skin or skin structure infection.~   "
131127|NCT01339078|"~     Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases.~     Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of~     choice. Problematic in this approach is the regular change, necessary to overcome occlusion~     of the stent, resulting in cholestasis and/or infection. This change needs to be performed~     every 3 months or more frequently in patients with symptoms of stent occlusion.~      The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the~     treatment of biliary anastomotic strictures post liver transplantation. The advantage could~     be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6~     months).~      No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes~     stenting.~   "
131128|NCT01339065|"~     . Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult~     patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect~     on the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.~      . Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult~     patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on~     the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.~   "
131129|NCT01339052|"~     BKM120 is a newly discovered drug that has been used in other research studies. Information~     from those other research studies suggests that BKM120 may help to slow or stop the growth~     of malignant gliomas. The purpose of this study is to see how well BKM120 works in patients~     with malignant gliomas. Patients on this study will be treated in two groups: patients who~     are going to receive surgery and those who will not receive surgery. This study is trying to~     determine how effective BKM120 is in stopping cancer cells from growing. For patients~     receiving surgery the research will also try to determine if an effective level of BKM120~     can penetrate the brain before surgery.~   "
131130|NCT01339039|"~     Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells~     from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in~     patients with recurrent glioblastoma and has been studied extensively in other types of~     solid tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with~     non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other~     cancers. Information from experiments in laboratories suggests that the combination of~     plerixafor and bevacizumab may help prevent the growth of gliomas.~      Part 1: The investigators are looking for the highest dose of plerixafor that can be given~     safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The~     investigators will also do blood tests to find out how the body uses and breaks down the~     drug combination.~      Part 2: The investigators are looking to see if plerixafor can get past the blood-brain~     barrier and into brain tumors. The investigators will also do blood tests to find out how~     the body uses and breaks down the drug combination.~      Part 3: The investigators are looking for for more information re: safety and tolerability~     of plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of~     plerixafor). The investigators will also do blood tests to find out how the body uses and~     breaks down the drug combination.~   "
131131|NCT01339026|"~     Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle~     (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ±~     stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and~     Clopidogrel) are blood thinning treatments and research has reported they reduce heart~     attacks, death and stroke. The investigators know some patients do not respond fully to~     Clopidogrel but currently patients are not tested for this.~      The investigators wish to perform a trial to identify those patients who do not respond~     fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of~     Clopidogrel.~      Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their~     consent to participate. A blood sample is tested for platelet activity.~        1. Low platelet activity result means patient has responded well to Clopidogrel and will~          continue on the routine dose. They will be entered into an observational registry. Data~          will be collected of routine blood tests and investigations, medication and procedures.~          Their GP will be contacted at about 30 days to see if they are alive.~        2. High platelet activity results means patient has not responded fully to Clopidogrel.~          These patients will be randomly allocated to a higher dose of Clopidogrel or new drug~          Prasugrel. Data will be collected of routine blood tests and investigations, medication~          and procedures. A hospital visit at 30±5 days is required to assess how patients are~          doing, medications and occurrence of any events.~   "
131132|NCT01339013|"~     The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon~     which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs~     and must be compensated for by increased ventilation. This study aims at determining how~     much compensation must be given, based on the hypothesis that rebreathing depends on carbon~     dioxide level in blood and exhaled air.~   "
131133|NCT01339000|"~     Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system.~     But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced~     naturally in the body, can help improve the function of the immune system. Researchers want~     to study the effects of IL-7 on immune system function in two different groups of older~     people. One group will be people who have received vaccines before IL-7. The other group~     will be people who have received Vaccines after IL-7.~      Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in~     older people following chemotherapy.~      Eligibility: People at least 60 years of age who have recently finished chemotherapy for~     breast, colon, or bladder cancer.~      Design:~        -  People in the study will be screened with a physical examination, medical history, and~          blood tests. Other screening tests, such as tumor imaging, may also need to be~          performed.~        -  Everyone will receive a series of five different vaccines commonly used to prevent~          diseases. We will compare the responses of people in Sequence 1 who will receive~          vaccines before IL-7 with the responses of people in Sequence 2 who received the same~          vaccines after IL-7.~        -  The vaccines will be given randomly in two Arms at different times.~             -  Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots),~               hepatitis B (with two booster shots), and hepatitis A (with one booster shot),~             -  Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots),~               pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia~               (with two booster shots)~        -  There are 5 vaccines to be given to each subject, following one of two randomly~          assigned sequences of vaccine administration (Sequence 1 or Sequence 2).~        -  The first vaccine arm contains the two diphtheria protein containing vaccines tetanus~          and diphtheria (Td) and pneumococcal conjugate 13 (PCV13) and polio. The second vaccine~          arm contains the Hepatitis A and Hepatitis B vaccines. Subjects will either get~          tetanus, diphtheria, polio, and pneumonia vaccines before IL-7 therapy (Sequence 1) or~          hepatitis A and hepatitis B vaccines before IL-7 therapy (Sequence 2). The response to~          vaccines will be evaluated 4 weeks after vaccination. This will be followed by IL-7~          therapy, then administration of the other group of vaccines. Therefore, subjects on~          both arms will receive the same set of vaccines, just at different times with respect~          to IL-7 therapy.~   "
131134|NCT01338987|"~     Background:~        -  One way to treat certain cancers of the blood and immune system is to give a patient~          stem cells from the bone marrow of a donor whose genes are very similar but not~          identical to the patient s. One problem with these transplants is that the new immune~          cells may not work as well in the recipient as they did in the donor. The result may be~          that the immune system will not work as well. This can increase the risk of severe~          infections and other complications.~        -  Researchers are studying the use of drugs that lower hormone levels and may allow the~          immune system to recover in a way that improves white blood cell function. In this~          study they will be looking at the drug lupron, a drug that lowers estrogen or~          testosterone levels, to see if it might improve the function of the newly transplanted~          cells.~      Objectives:~        -  To determine whether lupron improves immune system function after bone marrow~          transplantation from a donor with similarities in their immune cells (matched to each~          other).~        -  To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in~          imaging studies. FLT will be used to image the immune system function in patients who~          have received bone marrow from the donor.~      Eligibility:~        -  People between 15 (or as young as 9 in those who have gone through puberty) and 40~          years of age. These patients must have acute myelogenous leukemia, acute lymphocytic~          leukemia, or high-risk myelodysplastic syndrome. They must also be eligible for a bone~          marrow transplant.~        -  Genetically similar donors for the patients who are eligible for a transplant.~      Design:~        -  People taking part in the study will be screened with a physical examination, medical~          history, blood and urine tests, and imaging studies. Patients who are not in remission~          or who require a bone marrow donor search may receive chemotherapy first.~        -  Donors will provide bone marrow for transplant according to standard bone marrow~          transplant (BMT) procedures.~        -  All women and half of the men will receive regular lupron doses 2 weeks before BMT to~          suppress hormone function.~        -  All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy~          before the bone marrow transplant (depending on age). Recipients will also receive~          other drugs to prevent transplant rejection and other complications of transplantation.~        -  Recipients will be monitored in the hospital for 4 weeks after transplant with blood~          tests and other studies.~        -  Some recipients will have an imaging study with FLT during the protocol. These imaging~          studies will take place before the transplant, on days 5 and 28 after transplant, and~          at a later time to be determined by the study researchers.~        -  Following discharge, participants will be monitored closely for up to 6 months, with~          regular but less frequent followup visits for at least 5 years. Study-related~          medications, including vaccinations for the new immune system, will be provided by the~          National Institutes of Health during the hospital stay and after discharge.~   "
131135|NCT01338974|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer treated with~     cytarabine in the laboratory may help doctors learn more about the effects of cytarabine on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research trial studies biomarkers associated with response to cytarabine in~     samples from older patients with acute myeloid leukemia.~   "
131136|NCT01338961|"~     Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a~     century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To~     date, most studies have been conducted in coronary artery bypass graft (CABG) patients with~     conflicting results. Current evidence does not support one temperature management strategy~     for all patients. The purpose of this study is to compare the efficiency and safety of~     normothermic versus hypothermic CPB in valvular surgery patients.~   "
131137|NCT01338948|"~     The purpose of this study is to assess the feasibility of image-guided surgery in patients~     with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the~     assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance~     of will indicate the failure.~   "
131138|NCT01338935|"~     The purpose of this study is to test the safety and efficacy of an investigational~     neuromuscular blocking agent called CW002 and to document its effects on healthy adult~     volunteers. A neuromuscular blocking agent is a drug that temporarily prevents muscles from~     moving. CW002 has not yet been approved by the Food and Drug Administration (FDA).~      Usually, neuromuscular blocking agents are used together with other drugs that put people~     completely asleep. These drugs allow doctors to place a breathing tube in the airway, stop~     muscles from moving during surgical operations, and allow ventilation (movement of air).~      This research is being done because CW002 is expected to act quickly and to provide a muscle~     block of intermediate (not too long, not too short) duration. The researchers would like to~     test increasing doses of CW002 that can be given without causing severe side effects. If~     shown to be both safe and effective, such a compound would be useful in surgical procedures~     and could improve future anesthetic care.~   "
131139|NCT01338922|"~     The effect of change in diabetes treatment from multiple daily insulin injection therapy to~     continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life,~     diabetes burden, parents stress level, fear, family conflicts) in families with children and~     adolescents with diabetes mellitus type 1 will be analysed. Additionally the effect on~     metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) will be analysed.~   "
131140|NCT01338909|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological~     study with a parallel design. Patients with ST elevation myocardial infarction undergoing~     primary percutaneous coronary intervention and presenting high platelet reactivity as~     assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at~     2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will~     be randomized after informed consent, in a 1:1 ratio to the following treatment groups:~      Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after~     randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day~     starting from Day 1 until Day 5 (5 days after randomization).~      Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h~     after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events~     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and~     serious adverse events (bleeding, other adverse events)will be performed until Day 5.~   "
131141|NCT01338896|"~     The primary objective of the study is to compare the adhesiveness of two different patch~     formulations of rotigotine using patch size 40 cm2, under the assumption that both patch~     formulations show similar adhesiveness properties.~   "
131142|NCT01338883|"~     This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately~     150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by~     HIV-1 RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to~     receive:~        -  Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD +~          EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.~        -  Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS +~          FTC/TDF (1 tablet) QD.~        -  Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1~          tablet) QD.~      Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study~     drug. FTC/TDF will be administered as open-label study drug in a fixed-dose combination~     formulation (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken~     on an empty stomach at bedtime.~      HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at~     every visit. Samples for viral tropism and resistance testing in case of virologic failure~     will be collected at Screening and each on-treatment visit.~      Biomarkers associated with inflammation and immune activation will be measured at Baseline~     (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24,~     48, and 52.~      Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and~     fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at~     Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at~     Baseline and Weeks 24 and 48.~      Plasma samples will be collected and stored for possible future studies at Baseline~     (predose) and every visit thereafter.~   "
131143|NCT01338870|"~     B2611003 is designed to study how safe and effective an investigational medication~     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6~     treatments for 3 months. One of the treatments will be sitagliptin which is an approved~     drug, and another treatment will be placebo, which does not contain active ingredient.~   "
131144|NCT01338857|"~     The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors~     (low-grade astrocytomas) in children and adults. Previous research has given us a better~     understanding of this type of tumor by studying the genetic make-up of LGAs. From this~     research, the investigators found that a drug called sorafenib may stop the growth of tumor~     cells by blocking some of the molecules needed for cell growth and by blocking blood flow to~     the tumor. This trial is studying how well sorafenib works in treating patients with LGAs,~     and how the effects relate to the specific genetic make-up of your particular tumor. This~     testing of your tumor's genetic make-up is optional and requires available tumor tissue for~     testing. In summary, the aims of this study are: To see if sorafenib can shrink LGAs; how~     well sorafenib is tolerated in patients with LGAs; and, how the effects of sorafenib relate~     to the genetic make-up of individual LGAs (Optional Study)~   "
131145|NCT01338844|"~     Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various~     stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other~     Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).~      The hormonal control of multiple follicular growth and maturation is a critical part of ART~     procedures since it maximizes the yield of embryos to be transferred, thus increasing the~     cumulative pregnancy rate.~      Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and~     highly effective treatment in order to improve oocyte quality in patients undergoing IVF.~     Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable~     predictor of oocyte quality. High MI concentration in the FF directly correlates with high~     oocyte and embryo quality.~      Another stereoisomer of Inositol was successfully used into clinical practice~     D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in~     hyperglycemic PCOS patients.~      In the present study we aim to compare MI versus DCI supplementation on oocyte quality of~     women undergoing IVF-ET~   "
131146|NCT01338831|"~     The purpose of this first multi-dose study in cancer patients is to determine the maximum~     tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety,~     tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D~     chosen, the study will enroll patients into the expansion portion of the study.~   "
131147|NCT01338818|"~     This study will evaluate the long-term safety of methylphenidate hydrochloride extended~     release in adults with attention deficit/hyperactivity disorder~   "
131148|NCT01338805|"~     This long-term extension study will assess the safety, tolerability and efficacy of BGG492~     as adjunctive treatment in patients with partial onset seizures.~   "
131149|NCT01338792|"~     This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together~     works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in~     chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     oxaliplatin together with pemetrexed disodium may kill more tumor cells.~   "
131150|NCT01338779|"~     The purpose of this multi-center (observational) registry study is to establish a database~     of clinical and laboratory information that may help to identify any unique characteristics~     of tolerant participants that differ from participants who reject their kidney after~     discontinuing immunosuppressive drugs.~   "
131151|NCT01338766|"~     The purpose of this study is to evaluate the clinical performance of a decompression using~     the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and~     stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a~     55% positive response rate.~   "
131152|NCT01338753|"~     The purpose of this study is to compare the association between image and certain molecular~     markers with complete response in patients with locally advanced breast cancer, treated with~     neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.~   "
131184|NCT01338337|"~     Primary Outcome Measures:~      • To evaluate the efficacy of treatment with Azacitidine in patients with~     transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1,~     Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will~     be based on the erythroid haematologic response according to International Working Group~     (IWG) 2006 criteria.~      Secondary Outcome Measures:~        -  Haematologic response, bases on the following parameters: platelets, and neutrophils~          according to International Working Group (IWG) Criteria.~        -  Medullary and cytogenetic response according to International Working Group (IWG) 2006~          criteria.~        -  The effect of treatment response on quality of life, through the Functional Assessment~          of Cancer Therapy-Anemia (FACT-an) questionnaire.~        -  Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.~   "
131268|NCT01337089|"~     This is a six-month extension study to evaluate the safety of long-term Sativex® therapy~     when used as an adjunctive measure in patients with advanced cancer. The study provides~     continued availability of Sativex® to patients who completed the preceding Phase 3 study.~   "
131153|NCT01338740|"~     Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with~     intolerance or loss of response to Infliximab. Currently there are no studies on the~     efficacy of switching to Infliximab in patients with loss of response or primary~     non-response to Adalimumab. Even in rheumatology, where switching between all classes of~     anti-TNFα biologicals is common practice, there are no scientific data on switching from~     humanized to chimeric anti-TNFα antibodies.~      The purpose of this study is to document the efficacy of such a switch and to identify the~     possible predictive factors for success.~      If treatment with Adalimumab fails (despite optimal dose and interval) and the treating~     physician therefore decided to switch to infliximab, the patient may be enrolled in this~     observational study. At regular intervals (every Remicade), the patient will be clinically~     re-evaluated. The disease activity score will be calculated: Crohn's disease activity index~     (CDAI). At regular intervals, the results of interim blood tests will be documented (3x).~     The succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken~     for determination of antibodies against Adalimumab and Infliximab. The serum levels of~     Adalimumab (week 0) and Infliximab (week 10, 26 and 52) will be determined.~      For this study there is no specific therapy change. The study wants only to document the~     results of a therapy switch that, in current clinical practice, is made by the treating~     physician.~   "
131154|NCT01338727|"~     The primary objective of this study is to evaluate the efficacy of a specialized exclusive~     breastfeeding education and support program targeting obese, pregnant, low-income women in~     Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention~     on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims~     of this study are: a) to characterize postpartum weight loss patterns and blood pressure~     values of obese women, by study group; and b) to evaluate potential differences in infant~     morbidity (diarrhea, otitis media and rehospitalization), by study group.~   "
131155|NCT01338714|"~     The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective~     on HBV Carrier With Abnormal Liver Function.~   "
131156|NCT01338701|"~     This study investigates whether acupuncture can help to decrease the number and severity of~     headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two~     different types of acupuncture—either Traditional Chinese Acupuncture or ear acupuncture—to~     a group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce~     pain, improve health-related quality of life, prevent migraine headaches, and improve~     tension and chronic daily headaches.~   "
131157|NCT01338688|"~     The investigators want to determine whether TIG influences the formation of tetanus antibody~     after simultaneous tetanus vaccination according to age and the time-interval of the last~     tetanus vaccination.~   "
131158|NCT01338675|"~     In this study the investigators plan to use optimal busulfan dose through pharmacokinetic~     study in stem cell transplantation of CGD patients.~   "
131159|NCT01338662|"~     The purpose of this study is to compare the onset time and severity of dyskinesia in~     amantadine or Dopamine agonist initial treated groups in Parkinson`s disease.~   "
131160|NCT01338649|"~     Study objectives are to determine the efficacy, safety and tolerability of bright light~     treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients~     will be enrolled and equally randomized to bright light or dim-red light treatment.~     Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected~     through the baseline and intervention phases of the study. The primary outcome measure will~     be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment~     with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep~     Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease~     Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will~     examine the effects of bright light treatment on fatigue, depression, quality of life,~     cognition, and motor disability.~      Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time~     sleep in PD patients with daytime sleepiness.~   "
131161|NCT01338636|"~     The purpose of this study is asses whether ambrisentan can help people with Exercised~     Induced Pulmonary Arterial Hypertension. The investigators also want to find out if~     ambrisentan is safe to take without causing excessive side effects.~   "
131162|NCT01338623|"~     The purpose of this study is to compare the bioavailability (rate and extent of absorption)~     of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover~     study with a seven-days washout interval was conduced in 32 healthy male volunteers. The~     plasma samples were obtained up to 72 hours after drug administration. A sensitive and~     specific LC-MS/MS method was developed and validated for the determination of tansulosine in~     human plasma. Bioequivalence between the products was determined by calculating 90%~     confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.~   "
131163|NCT01338610|"~     The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing~     the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale~     (VAS) discomfort score.~   "
131164|NCT01338597|"~     The purpose of this study is to investigate whether reduced subcutaneous dissection area~     could offer patients more clinical benefits.~   "
131185|NCT01338324|"~     The small bowel biopsy is the cornerstone of for the diagnosis of celiac disease. In~     addition to being the gold standard for the initial diagnosis of celiac disease, periodic~     biopsies are also recommended on an ongoing basis for this life-long disease. However,~     biopsy evaluation is invasive and expensive. Therefore, there is a need for simple,~     non-invasive tests that can be performed on celiac patients with subclinical disease.~      The present study is based on the hypothesis that the expression and activity of cytochrome~     P450 CYP3A4 in the small intestinal mucosa is a sensitive measure of enteropathy. Therefore~     small intestinal CYP3A4 activity will be markedly different in celiac disease patients with~     active disease as compared to patients in remission. Small intestinal CYP3A4 activity will~     be measured in three ways:~      (i) Cmax of oral simvastatin, a widely used drug that is predominantly metabolized by small~     intestinal CYP3A4; (ii) AUC of oral simvastatin; and (iii) Measurement of CYP3A4 activity in~     two small bowel biopsies.~   "
131338|NCT01336140|"~     The routine administration of 75 mg of intravenous aminophylline in patients with severe~     chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can~     reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.~   "
131165|NCT01338584|"~     Urinary incontinence after radical prostatectomy is a significant clinical problem despite~     advances in surgical techniques. In the literature, the incidence of post prostatectomy~     urinary incontinence varies widely from 0.5 to 87% (Parekh et al, 2003). Various reasons are~     held responsible for this wide discrepancy, including surgical technique, definition of~     incontinence, time of evaluation, pathological stage, and patient age. The etiology of post~     prostatectomy urinary incontinence has been attributed to sphincteric deficiency, either~     from injury of striated muscle fibres or the innervating nerve fibres (Koelbl et al 2002).~     The effect of urinary incontinence on the quality of life in these patients has been subject~     to debate (Litwin et al, 1995; Braslis et al, 1995). For many patients, however, early~     recovery from urinary incontinence has been a major concern (Moore et al, 1999), especially~     in younger patients.~      Various treatment modalities for post prostatectomy urinary incontinence have been~     introduced, including conservative managemnt such as pelvic floor muscle training,~     pharmacological treatment and surgical treatment. However, surgery is an invasive procedure~     and it's usually be the last resort. Although the Cochrane Incontinence Group (2007)~     commented on the need for ongoing research to clarify the role of pelvic floor muscle~     training, it is still the first-line treatment used to restore pelvic floor or bladder~     function after radical prostatectomy (MacDonald et. al., 2007). Currently, patients learned~     pelvic floor muscle training on the day of admission for surgery by ward staff in HA~     hospitals of Hong Kong. Subsequently, after removal of urethral catheter, patients will~     attend the nurse-led clinic for reassessment and reinforcement of pelvic floor muscle~     training. The continence rates which defined as zero pad were 69%, 78.7% and 88.9% at 3~     months, 6 months and 12 months respectively (Tam and Ho et al., 2010). In order to determine~     the efficacy of intensive preoperative pelvic floor muscle training to decrease~     post-prostatectomy urinary incontinence, a randomized controlled trial will be conducted.~     Participants in the intervention group would start the pelvic floor muscle training 3 weeks~     before surgery provided by an urology nurse specialist whereas the control group would start~     the pelvic floor muscle training on the day of admission for surgery provided by ward staff.~     Measurement on the grams of urine loss, sense of self control in urination and quality of~     life are collected on 4, 8, 12 and 24 weeks after surgery for comparison between the two~     groups.~   "
131166|NCT01338571|"~     This is a pilot study and will be used to power an NIH grant application on the effect of~     resistant starch on weight gain in children.~   "
131167|NCT01338558|"~     This randomized, open-label study will evaluate the safety and efficacy of Avastin~     (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage~     IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be~     assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each~     2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in~     addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs.~   "
131168|NCT01338545|"~     This observational study will evaluate the dosage patterns, safety and efficacy of~     RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe~     rheumatoid arthritis who have not responded or are intolerant to at least one~     disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from~     each patients for 12 months.~   "
131169|NCT01338532|"~     The purpose of this study is to evaluate the time to total hip replacement in patients with~     hip osteoarthritis going through both a supervised exercise program and patient education~     compared to patients going through patient education only.~      The null hypothesis is: There are no differences in time to total hip replacement between~     patients with hip osteoarthritis who went through a 12 week supervised exercise program and~     patient education compared to patients who went through patient education only.~      Material and methods:~      109 patients with both symptomatically and radiographically verified hip osteoarthritis were~     included in this randomized controlled trial between april 2005 and october 2007. They were~     randomized to either a 12 week supervised exercise program and patient education (n=55) or~     patient education only (n=54).~      Information on if and when total hip replacement is performed will be collected between~     April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years.~     Data will be collected directly from the study participants by telephone.~      The main outcome is time to total hip replacement.~      Status:~      This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to~     evaluate the effect of supervised exercise and patient education.~      The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.~   "
131170|NCT01338519|"~     All newly referred patients with PCOS and hirsutism are listed in a database.~   "
131171|NCT01338506|"~     In comparison to the general population, U.S. military and Veterans are at an increased risk~     for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD).~     Current research has shown that there is a high comorbidity of SUD and PTSD, and although~     there are a number of treatments for SUD and PTSD independently, there are very few~     effective methods to simultaneously treat both disorders. Because of this substantial gap in~     the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment~     that would address and treat both disorders. Individuals, specifically U.S. military and~     Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach.~     This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in~     conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an~     empirically supported and evidence-based treatment that is currently regarded as the gold~     standard psychosocial treatment for PTSD. In combination with CBT, this treatment would~     address both disorders in hopes of reducing substance use and PTSD symptomatology.~   "
131172|NCT01338493|"~     The primary purpose of the study is to document the reduction of disability after Maverick~     total disc replacement surgery in a 'real-world' patient population requiring disc~     replacement.~   "
131173|NCT01338480|"~     This study is planning to develop the audiovisual videos and determine whether educational~     videos are superior to routine discussion for informing trauma patients in emergency~     department (ED) about risks, benefits, and alternatives to receiving surgery.~   "
131174|NCT01338467|"~     The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment~     using High Intensity Focused Ultrasound in refractory glaucoma patients.~   "
131186|NCT01338311|"~     Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness~     (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the~     long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The~     onset of tolerance to salbutamol is not known.~   "
131269|NCT01337076|"~     The Sponsor values the progression of hearing healthcare practice and acknowledges a need~     for re-evaluation of indications for determining adult cochlear implant candidacy. This need~     arises from current research, peer reviewed literature, and technological advancement with~     concomitant performance outcomes. To address this specifically, the Sponsor proposes to~     evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised~     indication.~   "
131339|NCT01336127|"~     The purpose of this study is to determine the effectiveness of occupational therapy in~     Parkinson's disease.~   "
131175|NCT01338454|"~     Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and~     was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur~     within 4 h of delivery and are a result of problems during third and fourth stages of labor.~     It also contributes significantly to serious maternal morbidity. Obstetric, surgical and~     radiological interventions play central role in the management of obstetric hemorrhage;~     however, pharmacologic management and in particular prohemostatic therapies also play an~     important role in the final maternal outcome. Administration of tranexamic acid (TA),~     intravenously in the third stage of labor may be one of these methods.~      TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly~     inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.~     TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In~     nonobstetric surgery, a systematic review of randomized controlled trails showed that~     tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI~     0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95%~     CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].~      In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and~     is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding~     associated with pregnancy (placental abruption, placenta previa) has also been treated with~     TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces~     postpartum hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is~     available evaluating the effect of TA use to prevent bleeding in the postpartum period~     following spontaneous vaginal delivery [12].~      The purpose of our study was to estimate the effect of the addition of intravenous TA to a~     standard active management of the third stage of labor (which includes prophylactic~     injection of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical~     cord, and controlled cord traction).~   "
131176|NCT01338441|"~     The study main objective is to assess the changes in the ventricular repolarization (measure~     by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify~     subjects with extreme responses and collecting their skin and blood samples.~   "
131177|NCT01338428|"~     More than one in six women will be sexually assaulted in their lifetimes, most by men they~     know. The risk of sexual assault by men is greatest for girls and women between the ages of~     14 and 24 making this a critical time for intervention. Sexual assault has many immediate~     and long-term negative consequences for victims. Even a small increase in the ability of~     women to resist sexual assault will result in a substantial improvement in the mental and~     physical health of women. Recent research has suggested that many young women delay their~     resistance to unwanted sexual advances because they are not sure that they are reading the~     situation correctly, they do not want to hurt the man's feelings, or they are unsure whether~     they have the right to say no to some sexual activity and say yes to other activity. Earlier~     work from the researchers resulted in the development of a program affecting these critical~     areas. This program was shown to be effective in helping participants build skills and a~     knowledge base to help them resist sexual assault and to prepare them for better recovery~     following sexual assault. The randomized controlled trial (RCT) builds on this prior work.~     We will establish whether the demonstrated short term effectiveness of this theoretically~     and empirically sound rape resistance intervention for university women extends to longer~     periods. We will determine whether the program can reduce the one year incidence of sexual~     assault by 30% among women attending Canadian universities. The results will also be used to~     indicate how long the effects of the program last and will indicate at which point in time~     refresher sessions may be necessary. A lay summary of the findings of the trial with a focus~     on application will be provided to all Canadian universities and to Provincial/Territorial~     Ministries of Education. This will be followed up with contact with those most likely to be~     involved in current campus education efforts.~   "
131178|NCT01338415|"~     The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,~     tolerability and efficacy of the pediatric formulation of bosentan two versus three times a~     day in children with Pulmonary Arterial Hypertension (PAH).~   "
131179|NCT01338402|"~     The purpose of this study was to assess the ocular response to and performance of the~     cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK®~     COLORBLENDS.~   "
131180|NCT01338389|"~     Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable~     results in causing tumor regression while preserving the eye. Optic neuropathy has emerged~     consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No~     neuroprotective strategies are available at present.~      Citicoline is a choline agent precursor available as a dietary supplement. Citicoline~     conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models.~     In ophthalmology, citicoline has demonstrated a significant action in improving retinal and~     cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic~     neuropathy). Citicoline also exhibits a very low toxicity profile in humans.~      The purpose of the study is to demonstrate whether daily oral administration of citicoline~     in patients treated for uveal melanomas with proton beam therapy, prevents or delays the~     occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual~     evoked potentials are measured. The tolerability/safety of the product is also evaluated.~   "
131181|NCT01338376|"~     Diabetes is a common, costly condition associated with significant morbidity and mortality.~     Diabetes self-management education, the process of teaching individuals to manage their~     diabetes, has been considered an important part. The intensive education has the capacity to~     deliver effective interventions to a large number of people. The investigators may be able~     to redirect our efforts to diabetes care and education strategies that will have a positive~     impact on the optimization of glycemic control and the prevention of long-term complications~     of diabetes, reducing the subsequent human and health care costs.~   "
131182|NCT01338363|"~     The purpose of this study is~        1. To describe patient characteristics and drug usage among children that are prescribed~          esomeprazole for the first time and to compare them with patients who are prescribed~          other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.~        2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia,~          gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis~          and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs~          and H2-receptor antagonists.~   "
131183|NCT01338350|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and~     post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours~     urine cortisol) of AZD5423 following administration of single and multiple ascending doses~     in healthy male Japanese subjects.~   "
131187|NCT01338298|"~     Prolactin is a hormone that naturally occurs in the body. Some women taking antipsychotic~     medications may have high levels of prolactin in their bodies. High levels of prolactin may~     cause women to have problems with sex or satisfaction from sex. It may also cause women to~     have fewer or no menstrual periods. It may also cause the production of breast milk and may~     contribute to long term bone loss.~      In this study, the investigators are testing whether taking adding a low dose of an~     antipsychotic medication called aripiprazole may help improve high prolactin levels and help~     with sexual dysfunction or problems with menstrual periods. The investigators are also~     looking to see if it may slow the loss of bones. This medication has been shown to be~     helpful for improving symptoms of schizophrenia.~   "
131188|NCT01338285|"~     Background:~        -  Research suggests that occupational exposure to formaldehyde is associated with~          increased risk for myeloid leukemia, but the significance of these findings is~          uncertain because of inconsistencies among studies and lack of knowledge of how~          formaldehyde can cause leukemia.~        -  Damage to the DNA of myeloid cells (type of white blood cell) or an environmental~          factor not affecting the cell genetic machinery may be involved.~      Objective: To determine if formaldehyde exposure is associated with genetic or other changes~     in myeloid cells.~      Eligibility: Workers exposed to high levels of formaldehyde and unexposed workers in~     Guangdong Province, China.~      Design:~        -  40 exposed workers and 40 unexposed workers will be enrolled.~        -  Subjects wear small instruments at work that measure chemicals in the air for 1 or 2~          days.~        -  Subjects have a brief physical examination and provide blood, urine, and mouth rinse~          samples.~        -  Subjects answer a questionnaire about work, smoking and drinking, use of medicines,~          medical history, general health, exposure to radiation and exposure to various~          substances at home.~   "
131189|NCT01338142|"~     The study objective is, to evaluate the fractional absorption of calcium from amorphous~     calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in~     postmenopausal women.~   "
131190|NCT01338129|"~     The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome~     (CRPS)~   "
131191|NCT01338116|"~     Severe bacterial infections are associated with mortality of about 30%. Patients with~     moderate to severe bacterial infections given early and appropriate empirical antibiotic~     treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to~     6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical~     antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous~     treatment.~      TREAT is a computerized decision support system for antibiotic treatment in inpatients with~     common bacterial infections. TREAT is based on a state of the art stochastic model of the~     domain (a causal probabilistic network) and uses a cost benefit model for antibiotic~     treatment, including costs assigned to future resistance. It was tested in a randomized~     controlled trial in 3 countries and shown to improve the percentage of appropriate empirical~     antibiotic treatment while at the same time reduce hospital stay and the use of~     broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited~     information available within hours of presentation.~      A second attractive approach to improve antibiotic treatment is to use techniques that do~     not depend on cultures, and thus shorten the time to identification of the pathogen to a few~     hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid~     amplification test for pathogens causing bloodstream infections.~      The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will~     improve the outcome of inpatients with moderate to severe bacterial infections, while at the~     same time reducing the use of broad-spectrum antibiotics, with no or little additional~     costs. A secondary objective will be to assess the sensitivity and specificity of whole~     blood PCR, using TREAT as the reference standard.~   "
131192|NCT01338103|"~     The purpose of this study is to determine whether Rituximab, in the same doses as used in~     rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune~     function via the Cylex assay in pemphigus patients before and after treatment with~     RItuximab.~   "
131193|NCT01338090|"~     This is a pilot study for evaluation of 89Zr-bevacizumab PET imaging as predictive biomarker~     during treatment with everolimus in patients with neuroendocrine tumors.~      Patients with progressive disease during the last year will receive treatment with~     everolimus 10 mg/day orally and 89Zr-bevacizumab PET imaging will be performed before start~     of treatment and after 2 and 12 weeks of treatment in the first three patients. If the scan~     after 2 weeks of treatment is already informative further patients will not undergo a scan~     at 12 weeks. A scan is considered already informative if both scans show at least 30%~     decrease in uptake in case of response, or at least 30% increase in uptake in case of~     disease progression.~      Four days before the scan patients will be injected intravenously 37 MBq, protein dose 5 mg~     89Zr-bevacizumab. At day 1, day 15 and day 99, PET images will be made for visualization and~     quantification of VEGF in the tumor lesions and blood will be drawn for determination of~     angiogenesis and mTOR pathway related biomarkers.~   "
131194|NCT01338077|"~     About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and~     regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD~     show an overall poorer response to PPI treatment than patients with erosive reflux disease.~     Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal~     reflux symptoms. This multi-center, double blind, randomized trial aims to compare the~     efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times~     daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD~     patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate~     relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms~     as assessed by reflux disease questionnaire before and after treatment, and patients overall~     satisfaction at the end of study. Safety assessments include incidence of adverse events and~     change of the laboratory test results. The study hypothesis is that treatment with sodium~     alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of~     the NERD patients.~   "
131195|NCT01338064|"~     Silicosis is well-known occupational disease caused by free crystalline silica (silicon~     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative~     evidences that exposure to Caesar stone (quartz surface products that manufactured from up~     to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers.~      Goals: To examine marble workers exposed to Caesar Stone in order to propose a working plan~     of surveillance and prevention by biological monitoring.~   "
131196|NCT01338051|"~     This project will use a community based participatory research orientation to develop a~     model for large scale campaign preventive healthcare interventions. The investigators have~     considerable expertise with cervical cancer screening and HPV vaccination. The investigators~     also have well tested methodologies for cervical cancer screening that are highly effective,~     including self-sampling for HPV and improved specimen transport systems. Therefore, the~     investigators will use these medical interventions as the model preventive health~     interventions for this project.~   "
131205|NCT01337921|"~     The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain~     probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34~     weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with~     probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life,~     34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL)~     1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and~     24 months CGA.~   "
131206|NCT01337908|"~     This is a study of factors, such as pain, family support, psychological history and~     alcohol/substance use, that may influence whether a person experiences depression after~     their spinal cord injury.~   "
131197|NCT01338025|"~     The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC)~     alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV~     infected children, adolescents and young adults. The study was to see if there were changes~     in the HIV virus and if there were differences in immune function, viral load and medication~     side effects between the two groups over 28 weeks. Participants were assigned to either take~     3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28~     weeks of this study, if the participant was randomized to the continue HAART arm, he/she was~     not switched to a different or new, potentially suppressive HAART regimen, but continued on~     the current failing HAART regimen. However, if continuing HAART, the participant might be~     switched to a new regimen if their provider felt that it was clinically needed or the~     participant met certain study endpoints (e.g., drop in CD4, increase in viral load).~      At the end of 28 weeks, the participant had the choice of remaining on the assigned study~     group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they~     would be followed for another 24 weeks to compare the difference in immune function, viral~     load and medication side effects between the different groups.~   "
131198|NCT01338012|"~     This study is being conducted to examine the immune response generated by sipuleucel-T in~     subjects previously treated with sipuleucel-T in the androgen dependent setting. The study~     will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This~     is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial~     sites. The anticipated duration of the study is approximately 6 years.~   "
131199|NCT01337999|"~     The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary~     during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that~     is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these~     malignant conditions. In order to optimize the utility of HE4 as a tumor marker in~     premenopausal women, its expression in the normal menstrual cycle needs to be characterized.~     We hypothesize that HE-4 levels do not vary in the menstrual cycle.~   "
131200|NCT01337986|"~     Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and~     blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the~     hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery~     after optic neuritis from MS, will result in symptomatic improvement in visual function. The~     study will consist of one screening/baseline visit, one visit during treatment with active~     drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned~     to receive study medication or placebo for the first three weeks, followed by a two week~     wash-out, and then treatment reallocation for the latter three weeks.~   "
131201|NCT01337973|"~     The purpose of this study is to examine the impact on both clinical (violence and substance~     use) outcomes and health services use (substance use disorder and mental health treatment)~     compared to standard SUD treatment (enhanced treatment as usual) of~        1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence~          prevention treatment intervention delivered during the 8-week early substance use~          disorder treatment phase; and~        2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period~          following the early treatment phase MI-CBT+CC).~      The study will provide important new information regarding the role and relative impact of~     both early treatment and continuing care interventions designed to impact substance use and~     violence, and whether combining such interventions yields additional benefits.~   "
131202|NCT01337960|"~     Veterans and other Americans who survive stroke often face disabling motor impairments that~     impede performance of activities of daily living and limit free-living activity. Prominent~     among these are diminished walking and balance functions, which not only foster a sedentary~     lifestyle and physical deconditioning, but also increase the risk of injuries due to falls.~     Recent research has demonstrated how motor learning based interventions can modify brain~     activity and improve motor functions in persons with stroke. Now there is a major research~     opportunity to advance the effectiveness of these interventions by applying new robotics~     technologies to improve control of essential functions such as gait and balance. One~     critical area for performance of walking and standing balance is the control of the ankles,~     as they are a major conduit of mechanical power in gait and also modulate torques affecting~     the motion of the whole body center of mass when balancing. Thus the current proposal is~     designed to investigate two approaches for using an impedance controlled ankle robot to~     improve gait and balance among stroke survivors with chronic lower extremity weakness. One~     approach uses the ankle robot in a seated visuomotor training program that focuses has~     subjects play video games with the weaker ankle to improve paretic ankle motor control that~     may carry over to gait and balance functions. The other approach uses task-specific gait~     training by integrating use of the ankle robot during treadmill exercise training to assess~     effects on the same functions. The effectiveness of both robotics approaches will be~     compared to that of a treadmill exercise program without robotics.~   "
131203|NCT01337947|"~     The principal hypothesis of this study is that the micro and macro vasculature of young~     diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors~     which cause vascular dysfunction at multiple levels of the arterial vasculature and that~     this dysfunction is demonstrable using state-of-the-art ultrasound methods. The~     investigators further hypothesize that interventions, such as exercise, that are readily~     integrated into the daily life of individuals with DM1 can mitigate or reverse these early~     vascular changes and thereby diminish the otherwise predictable longer-term development of~     cardiovascular disease (CVD) in type 1 DM~   "
131204|NCT01337934|"~     The use of albumin in critical ill patients is a matter of controversy. A large randomized~     controlled trial reported that albumin was as safe and effective as crystalloid solution for~     fluid replacement in intensive care unit, although the last one was less expensive. In~     Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids~     over colloids. But recently, a retrospective analysis of patients with severe sepsis from~     SAFE study reported that the use of albumin in these patients would be superior, regarding~     reduction of mortality. The aim of this study is determine whether the use of albumin~     improve clinical outcomes in patients with severe sepsis or septic shock.~   "
132855|NCT01316172|"~     This study intends to evaluate consultation in the Emergency Department. The purpose is to~     demonstrate that standardizing communication in the Emergency Department may lead to~     improved consultation.~   "
131207|NCT01337895|"~     -  Objectives Taking a 'whole foods' approach, we will investigate (i) whether consumption~          of isocaloric diets containing ≥4 vs. ≤1 servings of dairy products per day for 16~          weeks results in greater body fat loss in energy-restricted overweight/obese~          premenopausal women; (ii) the role of dairy product consumption in influencing~          physiological and metabolic factors which may precede or accompany changes in body~          composition, including in enzymes which synthesize and break down body fat; and (iii)~          factors, including obesity phenotype, which may influence the response of body~          composition to dairy product consumption.~        -  Background~      With the obesity epidemic showing no signs of abating, there is ongoing interest, both at~     the lay public and scientific levels, in manipulating the diet to promote weight,~     specifically fat, loss. One such promising manipulation is an increase in, or perhaps more~     precisely, an isocaloric substitution of, dairy product consumption. The inverse association~     between Body Mass Index (BMI) and dietary calcium - for which dairy products are the main~     source - was first described in 1984 and has since been supported by various levels of~     evidence, but not consistently. Heaney recently described this literature as confused,~     which he and Rafferty attribute to important limitations in study design, including lack of~     low-calcium contrast groups and the fact that body weight/body composition is often a~     secondary endpoint in studies designed and powered for a different outcome, typically bone~     health or blood pressure. Confusion has also arisen from the investigation of different~     interventions (dairy products, dairy calcium, dietary calcium, supplemental calcium), making~     it difficult to compare and interpret studies. This creates an opportunity for the proposed~     Dairy and Weight Loss (DAWL) study, with its focus on whole dairy product consumption, to~     help clear up the confusion surrounding this issue.~      **Hypotheses~      Overweight/obese, low habitual dairy consuming, premenopausal women randomized to an~     energy-restricted weight loss diet containing ≥4 servings/day of dairy products (milk,~     yogurt, cheese) for 16 weeks will lose more body fat than those randomized to an isocaloric~     diet containing ≤1 servings/day of dairy products.~   "
131208|NCT01337882|"~     Exposure to particulate air pollution has been shown to increase cardiovascular mortality~     and morbidity, and in previous controlled exposure studies has been shown to have acute~     cardiovascular and respiratory effects. The last decade has seen an unprecedented drive~     towards finding a bioeconomical and renewable source of fuel in order to reduce our~     dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as~     contenders for future fuels, biodiesel remains as the strongest contender within European~     markets. In 2007 researchers at the EPA released a commentary, which concluded that the~     assumed correlation between the chemical composition of biodiesel exhaust and a reduction in~     health effects was only hypothetical. They suggested that there was a clear need for the~     study of health effects in humans regarding biofuel exhaust. In this project the~     investigators aim to investigate the cardiovascular, respiratory and inflammatory responses~     to biofuel exhaust exposure in healthy volunteers.~   "
131209|NCT01337869|"~     A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and~     skin debris. The condition is common and requires surgery to be cured. Several surgical~     procedures are described in literature. Limberg Flap technique is frequently used technique~     for this disease all over the world. However, Bascom Cleft Lift Technique is relatively~     newer technique. The purpose of this prospective randomized study is comparison of these~     techniques about patient satisfaction for postoperative period.~   "
131210|NCT01337856|"~     This is a randomized controlled trial comparing the effectiveness of three hand hygiene~     protocols, during routine inpatient clinical care: Protocol 1: handrubbing with alcohol~     covering all hand surfaces in no particular order; Protocol 2: handrubbing with alcohol~     using the WHO standard 7-step technique; and Protocol 3: handwashing with chlorhexidine~     using the WHO standard 7-step technique.~      The main study hypothesis is that alcohol hand-rubbing covering all hand surfaces is not~     less effective in reducing bacterial hand contamination of healthcare staff than alcohol~     hand-rubbing using 7-step technique; and is more effective than chlorhexidine handwashing.~     The secondary study hypothesis is that time spent on alcohol hand-rubbing covering all hand~     surfaces is less than that required by the other 2 hand hygiene protocols respectively.~   "
131211|NCT01337843|"~     This research will evaluate the efficacy of a new online self- help intervention, the~     Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be~     randomly assigned to use the Wellness Workbook or alternative self-help materials and~     assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome~     measures include pain-related disability and pain severity.~   "
131212|NCT01337830|"~     Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on~     reducing craving for a cigarette in daily smokers.~   "
131213|NCT01337817|"~     Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen~     Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when~     tobacco is smoked.~   "
131214|NCT01337804|"~     This study compares the bioequivalence of omeprazole administered as either Zegerid® powder~     for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.~   "
131215|NCT01337791|"~     Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic~     hepatitis B patients with few adverse effects, but its use during pregnancy has not been~     explored. In this open-label, prospective study from the second trimester to post-partum~     week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in~     HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and~     elevated alanine aminotransferase levels.~   "
131216|NCT01337778|"~     A growing body of research indicates that gender-based violence (GBV) is a major global~     public health challenge. Yet, there is a dearth of evidence to guide program planning and~     policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and~     potential effectiveness of an innovative women's empowerment intervention to reduce GBV and~     related adverse health outcomes. It is expected that the study findings will provide~     evidence to determine if a phase 3 effectiveness trial is merited and advance the science~     underlying GBV prevention.~   "
131217|NCT01337765|"~     This is an open label, dose finding, phase Ib clinical trial to determine the maximum~     tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in~     combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients~     with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast~     cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and~     other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be~     guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two~     expansion arms will be opened in order to further assess safety and preliminary anti-tumor~     activity of the combination of BEZ235 and MEK162.~      Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd,~     a treatment cycle is defined as 28 days.~   "
132856|NCT01316159|"~     Although atherosclerosis is a systemic disease, its manifestations are focal and eccentric,~     and each coronary obstruction progresses, regresses, or remains quiescent in an independent~     manner. The focal and independent nature of atherosclerosis cannot be due solely to the~     presence of systemic risk factors such as hyperlipidemia, diabetes mellitus, cigarette~     smoking, and hypertension. Local factors that create a unique local environment are a major~     determinant of the behavior of atherosclerosis in a susceptible individual.~      The vascular endothelium is in a unique and pivotal position to respond to the extremely~     dynamic forces acting on the vessel wall due to the complex 3-D geometry of the artery.~     Mechanical forces in general, and fluid shear stress (endothelial shear stress [ESS]) in~     particular, elicit a large number of humoral, metabolic and structural responses in~     endothelial cells.~      Regions of disturbed flow, with low and oscillatory ESS (< 1.0 Pa), are intensely~     pro-atherogenic, pro-inflammatory, and pro-thrombotic, and correlate well with the~     localization of atherosclerotic lesions. These sites demonstrate intense accumulation of~     lipids, inflammatory cells, and matrix degrading enzymes which promote the formation of~     high-risk thin-cap fibroatheroma.~      In contrast, physiologic laminar flow (1.0-2.5 Pa) is generally vasoprotective. However, as~     the obstruction progresses and further limits blood flow through a narrowed lumen, flow~     velocity and ESS may increase excessively (> 2.5 Pa) at the neck, and decrease abnormally at~     the outlet, increasing the likelihood of platelet activation and thrombus formation.~      Identification of an early atherosclerotic plaque likely to progress and acquire~     characteristics leading to likelihood of rupture and, consequently, to precipitate an acute~     coronary event or rapid luminal obstruction, would permit more definitive pharmacologic or~     perhaps mechanical intervention prior to the occurrence of a cardiac event. The potential~     clinical value of identifying and eradicating plaques destined to become vulnerable before~     they actually become vulnerable is enormous.~      The purpose of the PREDICTION Trial is to identify high-risk coronary lesions at an early~     time point in their evolution, to follow the natural history of these lesions over a 6-10~     month period, and to confirm that these high-risk lesions are likely to rupture and cause an~     acute coronary syndrome (ACS) or develop rapid progression of a flow-limiting obstruction.~     The hypothesis is that local segments in the coronary arteries with low ESS and excessive~     expansive remodeling will be the sites where atherosclerotic plaque develops, progresses,~     and becomes high-risk, leading to a new cardiac event. This study is being conducted in~     Japan as patients are clinically evaluated with followup coronary angiography and IVUS in a~     routine manner at 6-10 months following their initial percutaneous coronary intervention~     (PCI) for an ACS.~      This is a natural history and a clinical outcomes study in patients who initially present~     with an ACS. The natural history portion of the study is designed to describe the temporal~     progression of atherosclerosis in segments of coronary arteries with low ESS and expansive~     remodeling using intracoronary vascular profiling techniques utilizing intravascular~     ultrasound (IVUS) and coronary angiography. The clinical outcomes portion of the study is~     designed to evaluate the efficacy of coronary vascular profiling to predict segments of~     coronary arteries that will become areas of rapid plaque growth or rupture leading to~     recurrent major clinical coronary events.~      Five hundred (500) patients with acute coronary syndrome undergoing PCI for a culprit lesion~     are to be enrolled in the study to undergo coronary vascular profiling at the time of the~     index catheterization procedure. Up to 374 consecutive patients with at least one low ESS~     subsegment are to have follow-up coronary angiography and IVUS at 6-10 months to allow for~     at least 300 patients with analyzable intracoronary vascular profiling data for assessment~     of lesion natural history. All patients are to have a one-year clinical follow-up to assess~     for new cardiac events, followed by two additional years of extended clinical followup.~   "
131219|NCT01337739|"~     Patients undergoing deep sedation for outpatient procedures typically receive a combination~     of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include~     respiratory depression, nausea and vomiting, and urinary retention, with resultant extended~     hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may~     increase patient safety by maintaining respiratory drive, while providing sedation,~     hypnosis, and analgesia. Furthermore, patients may experience decreased pain, nausea, and~     time to discharge in the PACU, especially if dexmedetomidine decreases the requirement of~     other drugs such as opioids.~      The hypothesis of this study is administration of dexmedetomidine during deep sedation for~     ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid~     compared to sedation with propofol.~   "
131220|NCT01337726|"~     The purpose of this research study is to test a program developed to help patients with~     chronic heart or lung problems take care of themselves and cope with their illness or~     limitations.~   "
131221|NCT01337713|"~     There is an impressive and growing body of data suggesting that massage therapy is effective~     in decreasing some symptoms of pathological conditions as well as facilitating growth,~     reducing pain, increasing alertness, diminishing symptoms of depression and anxiety, and~     enhancing immune function. Preliminary studies suggest that massage therapy decreases~     symptoms of anxiety and depression, and lowers salivary cortisol levels in a wide array of~     childhood and adult neuropsychiatric disorders including post-traumatic stress disorder,~     attention-deficit-disorder hyperactivity, depression, bulimia and anorexia-nervosa.~     Generalized Anxiety Disorder (GAD) is characterized by the presence of a constellation of~     signs and symptoms for at least 6 months in duration, with some type of functional~     disability or decrease in quality of life. The signs and symptoms of GAD include a myriad of~     somatic symptoms including muscle tension, headaches, backaches, fatigue, restlessness,~     insomnia, as well as psychological feelings of worry, anxiety, and feeling overwhelmed. Both~     pharmacotherapy and psychotherapy are effective in decreasing the signs and symptoms of GAD.~     Unfortunately, the vast majority of patients with GAD never receive adequate pharmacotherapy~     or psychotherapy. Therefore, the development of a complementary and alternative therapy that~     has demonstrated efficacy for GAD might be well received by patients.~      This study's goals are to investigate the efficacy of Swedish massage therapy vs. light~     touch therapy and better understand the biological effects of massage in patients with~     anxiety. Qualified participants will be randomly assigned to one of two groups in which they~     will receive Swedish massage therapy twice per week for 12 weeks or Light Touch therapy~     twice per week for 6 weeks followed by Swedish massage therapy twice per week for the next 6~     weeks. The total length of the study is 13 weeks, which includes a screening visit that~     takes about 3 hours and two therapy visits per week for 12 weeks that last about 1 hour~     each. Blood and urine will be collected at three of the visits. Compensation is up to $400~     for completing the entire study.~   "
131222|NCT01337700|"~     Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive~     Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders~     beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates~     suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very~     substantial costs associated with caring for patients with ASD, and ASD has the highest~     Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,~     including social deficits, repetitive behaviors and language deficits. Patients can also~     have associated symptoms of attentional deficits, disruptive behaviors and intellectual~     disability. There is currently no Food and Drug administration (FDA) approved treatment for~     the core symptoms of autism, but risperidone and aripiprazole have FDA approval for~     disruptive behaviors associated with autism.~      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults~     with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and~     normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play~     a role in behavior adaptations and performance.~   "
131223|NCT01337687|"~     Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in~     speech and communication, impaired social functioning and repetitive behaviors and~     restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on~     facilitating uterine contractions and milk let-down; however, studies, mainly with rodents~     and non-human primates, has found that OT is involved in affiliative behaviors, including~     sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and~     other aspects of social attachment. Moreover, OT is known to play an important role in~     repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in~     social interaction are core symptom domains of autism, and that OT is involved in the~     regulation of repetitive and affiliative behaviors, it is believed that OT may play a role~     in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues~     suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic~     oxytocin administered via intravenous infusion to adults with autism spectrum disorders~     (ASD) produced significant reductions in repetitive behaviors and facilitated social~     cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.~      Encouraged by these findings, the primary aim of this study is to investigate the safety and~     therapeutic efficacy of intranasal OT in treating repetitive behaviors and social~     functioning/cognitive deficits in adults with ASD. This research embraces a translational~     approach to develop a novel treatment for core ASD symptoms; given that there are currently~     no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,~     this research addresses an important unmet need in the field. The goal of this study is to~     evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment~     (INOT)administration in adults with ASD.~   "
131224|NCT01337674|"~     This study will evaluate the safety and tolerability of MK-4618 when coadministered with~     antihypertensive agents and will evaluate changes in blood pressure following~     co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis~     of the study is that MK-4618 does not result in a clinically meaningful change in systolic~     blood pressure relative to placebo when co-administered with a beta-blocker or with~     amlodipine.~   "
131225|NCT01337661|"~     The purpose of this study is to observe how the inflammatory pathways differ in subjects~     with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD~     (AECOPD).~   "
131226|NCT01337648|"~     The purpose of this study is to develop fecal tests that will determine the extent of~     radiation exposure in patients undergoing radiation treatment for cancer. This project will~     determine whether fecal biomarkers can be used to diagnose exposure to radiation.~   "
131227|NCT01337635|"~     Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier,~     inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble~     vitamin that is primarily acquired through local production in the skin after ultraviolet~     light exposure but can also be obtained through natural and supplemental dietary sources.~     This randomized controlled trial will examine the effects of vitamin D repletion on atopic~     dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize~     that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency~     will have improved cutaneous disease after treatment with high dose as compared to standard~     dose vitamin D.~   "
131228|NCT01337622|"~     Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs~     the time to establish full gastric feeding in the early postnatal period.~   "
131526|NCT01333683|"~     Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a~     possible relationship between them, analyze the severity of tinnitus related to arterial~     hypertension and analyze a possible influence of ototoxic drugs used to treat arterial~     hypertension~   "
131229|NCT01337609|"~     The purpose of this study is to determine the safety and effectiveness of a nutritional~     supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which~     when taken in large enough amounts are supposed to provide a health benefit. The~     investigators would like to see whether this supplement can be used as a treatment for~     Irritable Bowel Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the~     study will have both IBS and MDD. In order to find out if GanedenBC30 is effective in~     treating IBS and MDD, the investigators will compare it to a placebo. About 32 people will~     take part in this research study. About half of these 32 people will take part at Charles~     River Medical Associates and half will take part at Burlington Medical Associates.~     Participants will be recruited from among patients already being seen at Charles River~     Medical Associates or Burlington Medical Associates for their primary care. The study will~     last for two months, during which time participants will make eight study visits and will~     take either Ganeden BC30 or placebo. The investigators hypothesize that subjects treated~     with the probiotic will have significantly better outcomes with regard to depression and IBS~     symptoms compared to those who receive placebo.~   "
131230|NCT01337596|"~     To evaluate the safety and tolerability of LY2951742 given as a single or multiple~     subcutaneous injection in healthy male subjects~   "
131231|NCT01337583|"~     This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety~     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.~   "
131232|NCT01337570|"~     This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety~     and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.~   "
131233|NCT01337557|"~     The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution)~     1.5% will have an effect on contact lens wear in patients with contact lens intolerance due~     to allergic conjunctivitis.~   "
131234|NCT01337544|"~     The investigators propose a new antitumor cell therapy for treating childhood refractory~     solid tumours. The aim of this study is explore the graft versus tumour effect mediated by~     allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor~     killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I~     alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell~     activation and elimination of those target cells. Reduced risk of relapsed has been~     described in malignant cancer after haploidentical stem cell transplantation when HLA~     ligands against the inhibitory KIRs present in the donor were absent in the recipient~     (KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural~     Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by~     cytokines or tumour cell lines.~      This will be an open, non randomized, Phase I/II clinical trial, with a double objective:~     therapeutic exploratory. The investigators aim at studying safety and efficacy of~     haploidentical stem cell transplantation for the treatment of these malignancies with no~     cure known. Patients will receive an haploidentical stem cell transplantation, followed by~     IL-15 stimulated NK cells infusion one month after transplantation. Efficacy of the~     procedure will be evaluated with up-to-date radiological techniques, molecular studies and~     functional assays.~   "
131235|NCT01337531|"~     Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when~     either recombinant or highly purified follicle stimulating hormone (FSH) is used.~   "
131236|NCT01337518|"~     This study will evaluate an experimental drug called EZN-4176 to determine the anticancer~     effects when it is given to patients with an advanced form of prostate cancer called~     castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out~     the dose of EZN-4176 that can be safely given without serious side effects and to determine~     the amount of EZN-4176 that should be given in future studies.~   "
131237|NCT01337505|"~     This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated~     dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450~     mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous~     infusion on Day 1 every 21 days for up to 6 cycles.~   "
131238|NCT01337492|"~     Patients with either histological confirmation or clinical diagnosis who are candidate for~     orthotopic liver transplant(OLT) will receive Sorafenib 400mg 2 x day (BID) as a neoadjuvant~     (bridging) treatment until transplant. If patient progresses or falls outside of the Milan~     criteria on sorafenib patient can be treated per physician's discretion using local therapy.~     Patient will be followed until 30 days after the orthotopic liver transplant (OLT).~   "
131239|NCT01337479|"~     The purpose of this study is to follow patients treated in entecavir Phase III and rollover~     studies for safety experience and Hepatitis B virus (HBV)-related complications.~   "
131240|NCT01337466|"~     This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy~     volunteers and patients with prosthetic joint infections. This pilot study will also~     investigate the safety and tolerability of [124I]FIAU.~   "
131241|NCT01337453|"~     Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological,~     autonomic, gastrointestinal, genitourinary, and cosmetic disorders. The use of this~     treatment requires expertise in dosage calculations and application technique to avoid~     potential side effects. Most adverse events (AEs) related to BoNT are local and related to~     its mechanism of action, i.e., paralysis of unwanted muscles. However, systemic AEs may also~     be observed. Flu-like symptoms (FLS) are well recognized AEs in patients treated with BoNT;~     however there is a paucity of information regarding the frequency, clinical impact, and~     associated risk factors of this particular complication.~      Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the~     Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of~     non-serious side effects.~      In this study, the investigators aim to assess prospectively the frequency, clinical~     characteristics, and risk factors for development of FLS in a group of patients affected~     with diverse movement disorders and treated with BoNT type A at the Parkinson's Disease~     Center and Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The~     investigators will also assess biomarker of inflammatory response in those patients who~     develop FLS after treatment with BoNT.~   "
131527|NCT01333670|"~     The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation~     Solution compared with standard isotonic solution on infammation reduction and wound bed~     cleansing of chronic pressure or vascular leg ulcers.~   "
131242|NCT01337440|"~     1. Objectives~        1. To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1)~          response to nutrients and improves glycemic control in people with type 2 diabetes.~        2. To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and~          glycemic control.~        3. To test safety of combination therapy of sitagliptin and UDCA in people with type 2~          diabetes.~      2. Clinical hypothesis.~        1. UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the~          liver to the intestine/colon.~        2. UDCA improves glycemic control in people with type 2 diabetes.~        3. Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.~        4. Sitagliptin has additive beneficial effects with UDCA in glycemic control in people~          with type 2 diabetes.~        5. Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with~          type 2 diabetes.~        6. The combination therapy may loose weight by unique mechanisms of each agent; GLP-1~          inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced~          circulating primary bile acids increases energy expenditure through the pathway~          involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and~          subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and~          muscle tissues, as reported previously.~   "
131243|NCT01337427|"~     This research sub-study is being completed as a part of the Multicenter, Randomized,~     Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety~     of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis~     (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017~     by measuring the nerve fiber thickness in the eye.~   "
131244|NCT01337414|"~     Exudative age-related macular degeneration (wet AMD) continues to be a leading cause of~     central vision loss in the US for those over fifty years of age, despite the availability of~     several effective interventions to contain damaging neovascularization (new, abnormal blood~     vessel growth). The effectiveness of treatments is challenged by patients' lack of ability~     to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi~     tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling~     patients to recognize the signs that they should consult their retina specialist for~     treatment.~      For optimal benefit, patients should be able to self-monitor their vision over time and~     detect changes that may be indicative of an exudative event. To facilitate compliance these~     observations should be part of a larger and more engaging program of AMD awareness and~     self-monitoring. Among the principal shortcomings of the current gold-standard Amsler grid~     are periodicity of the test pattern and lack of individual adjustment, and therefore the~     reliability and accuracy of this test are less than optimal for the detection of exudative~     retinal changes in AMD patients. In phase I of the current study, the investigatorsW~     developed and evaluated several versions of improved grids, both on paper and on the~     Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least~     equivalent to the Amsler grid in facilitating a substantial degree of recall of prior~     measurements, necessary for monitoring vision over time. Adjustment features were~     incorporated in the on-line version to allow patients to customize their grid to their~     particular visual field. In the phase II study the use of VMS grids will be supplemented by~     a test booklet that contains educational materials and diary based survey questions in~     addition to the printed VMS grids; the effectiveness of this booklet for self-monitoring~     will be compared the standard of care (Amsler grid).~      Goal of the study is to demonstrate that use of the test booklet leads to more rapid~     identification of newly developing vision problems, earlier diagnosis and treatment of~     incipient wet AMD that should result in fewer people losing their vision and less severe~     losses of vision.~   "
131245|NCT01337401|"~     The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial~     of cediranib in Alveolar Soft Part Sarcoma (ASPS).~      The study aims to confirm the ability of cediranib to halt disease progression in patients~     with metastatic ASPS, as measured by the change in tumour size at 24 weeks after~     randomisation, and to produce objective response according to RECIST criteria.~   "
131246|NCT01337388|"~     This observational study will assess the efficacy and safety of RoActemra/Actemra~     (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from~     patients treated in routine clinical practice with intravenous RoActemra/Actemra will be~     collected for 12 months each.~   "
131247|NCT01337375|"~     In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon~     alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with~     viral load and viral kinetics will be investigated in patients with chronic hepatitis C~     genotype 1 who were non-responders to previous standard combination therapy with pegylated~     interferon and ribavirin. Patients will be randomized to receive either weekly or twice~     weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after~     a washout period of 6 weeks.~   "
131248|NCT01337362|"~     Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as~     a severe side effect to insulin therapy, in particular subjects who have lost warning of~     hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with~     electroencephalography (EEG) as cognitive function declines.~      The purpose of the study is to investigate the activity in the brain, the cognitive~     function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The~     results will show whether the response to hypoglycaemia will change after repeated episodes.~      It is our hope that results can contribute to improved understanding of hypoglycaemic EEG~     changes.~   "
131249|NCT01337349|"~     This is a prospective, double blinded randomized clinical study to evaluate the Effects of~     Pentoxifylline on left ventricular systolic function indices and circulating biomarkers in~     patients with chronic congestive heart failure.~      A few studies all focused in Africa have consistently shown marked beneficial effects of~     pentoxifylline in improvement of left ventricular size and systolic function along with~     marked decrease in biomarkers of heart failure and apoptosis markers on top of standard CHF~     therapy. Furthermore pentoxifylline was shown to have negligible effects on heart rate,~     blood pressure in those studies. Limitations of these studies are that they are largely~     single center originating in the African subcontinent and have never been tested in the~     North American population, particularly Caucasians.~      Despite major advances in medical therapy for congestive heart failure, it is still one of~     the leading causes of morbidity and mortality in North America. Most medications tested for~     improvement of Ejection Fraction with the exception of Beta-Blockers and Ace-Inhibitors have~     been associated with worsening mortality. Pentoxifylline is a medication that has negligible~     effects on myocardial oxygen consumption, yet promising effects on inflammatory markers seen~     in CHF with the possibility of improvement in LV systolic function and symptomology and may~     prove to be a useful addition for CHF patients. This would prove to be especially useful,~     particularly when associated with no major side effects.~   "
132507|NCT01320761|"~     To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately~     following injection and at regular intervals up to 24-hours post-injection following~     subcutaneous administration into the submental area.~   "
131250|NCT01337336|"~     The objective of this study was to examine COPD-related outcomes for patients with comorbid~     depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate~     compared to those receiving anticholinergics.~      The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary~     disease (COPD) is estimated to be high and range from 10-40%, given that the risk of~     depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD.~     Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related~     healthcare utilization and costs compared to those without depression/anxiety. Therapy with~     maintenance medications for COPD has been recommended to prevent future adverse COPD~     outcomes, but the impact of initiating these interventions has not yet been evaluated in a~     higher-risk population with comorbid COPD-depression/anxiety. The present study compares the~     risk of COPD exacerbations and COPD-related costs in patients initiating maintenance~     medications for treatment of COPD in a comorbid COPD/depression-anxiety population.~     Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist~     (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including~     tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively~     abbreviated as IPR).~   "
131251|NCT01337323|"~     This study is a prospective observational cohort study with 3-month follow-up among a cohort~     of intranasal steroid (INS) -experienced patients newly starting fluticasone furorate nasal~     spray (FFNS). The primary aim is to examine the effect of FFNS on the use and associated~     cost of concomitant allergic rhinitis medications in INS-experienced patients starting~     treatment with FFNS who have a history of prior concomitant medication use. The secondary~     aim will be to determine the effect of FFNS on control of allergic rhinitis, as assessed by~     the Rhinitis Control Assessment Test (RCAT).~      Adult patients filling a new FFNS prescription will be recruited (within 4 days of starting~     their FFNS) across 50 branches of a retail pharmacy chain with co-located convenient care~     clinics. Approximately 350 patients who have active seasonal rhinitis and have used an INS~     other than FFNS and another prescription or over-the-counter allergy medication in the~     previous allergy season will be eligible for the study. A baseline questionnaire will be~     administered to collect information on patient demographics, a brief medical history of the~     patient's rhinitis, prior use of INS and other prescription and over-the-counter medications~     taken for allergic rhinitis, total out of pocket costs for the prior allergy season, number~     of office visits due to allergic rhinitis, and level of control of symptoms of allergic~     rhinitis.~      At 1, 2, and 3 months post-enrollment, a follow-up questionnaire will be administered to~     collect information on medications taken for allergic rhinitis, office visits due to~     rhinitis, and level of control of symptoms of allergic rhinitis. In addition, pharmacy~     claims data will be abstracted for patients 1 year prior to enrollment and 4 months after~     enrollment to verify and supplement patient reported data as needed.~      The primary outcomes will be rate of use of non-INS concomitant medications (frequency and~     duration) at baseline, and 1, 2, and 3 months follow-up and change in rate of use of non-INS~     concomitant medications (post vs. pre and from baseline to 3 months follow-up). Secondary~     outcomes will be change in total allergic rhinitis pharmacy expenditures (post vs. pre and~     from baseline to follow-up) and change in the level of control of allergic rhinitis, as~     measured by score on the Rhinitis Control Assessment Test (RCAT), from baseline to~     follow-up.~   "
131252|NCT01337310|"~     Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of~     tesetaxel in Japanese patients has been limited. This study is being conducted to determine~     the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to~     Japanese patients.~   "
131253|NCT01337297|"~     The use of crack-cocaine is growing at alarming rate in our country and it is absolutely~     worrisome the fast establishment of addiction to it. Its immediate effects, that are intense~     and extremely fleeting, increase dramatically the probability of this drug to be consumed~     again, settling quickly down the loss of control and the compulsive use, turning the effects~     of this drug highly addictive. Parallel to this process, brain damages are quickly~     established, progressing to severe impairments of frontal functions, leading to the lack of~     cognitive control that feeds back and aggravates the dependence, and hampers any therapeutic~     approach. The existing treatments have not proved to be satisfactory yet. Thus, considering~     that a new modality of treatment, based on the neuromodulation induced by noninvasive brain~     stimulation, has been useful in treating various neuropsychiatric conditions, this study~     will examine the potential beneficial effects of repeated transcranial Direct Current~     Stimulation over the left dorsolateral prefrontal cortex in the treatment of crack-cocaine~     addiction.~   "
131254|NCT01337271|"~     The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or~     Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation)~     on its the ability to detect patients ready for extubation (liberation from mechanical~     ventilation).~   "
131255|NCT01337258|"~     The objective of this project is to conduct a retrospective economic analysis of the use of~     dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical~     trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical~     trial of the use of dutasteride compared with no chemopreventive treatment.~      The REDUCE trial was a four-year, international, multicenter, randomized, double-blind,~     placebo-controlled, parallel group study. There were 790 investigators in 42 countries.~   "
131256|NCT01337245|"~     The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and~     death from the bite of a coral snake.~      Funding Source - FDA OOPD.~   "
131257|NCT01337232|"~     This study is designed to examine how much therapy is needed in order to make significant~     gains in knowledge and use of complex sentences. Students will be randomly placed in~     individual treatment sessions that take place either once or twice per week for nine weeks.~     All will receive the same type of treatment, which consists of a focused series of oral and~     written language activities. While it is anticipated that students in both groups will~     benefit from treatment, we hypothesize that the twice-weekly session frequency will have a~     significantly greater impact on level of performance and maintenance of skills after~     treatment.~   "
131258|NCT01337219|"~     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic~     Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly~     related to the respiratory affection which appears early in neonates.~      The constant improvement in symptomatic treatments and care strategies allowed CF patients'~     life expectancy to be increased over the last decades.~      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18~     years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.~      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is~     obtained by inhaled administration of tobramycin and is active against in-vitro resistant~     Pseudomonas aeruginosa.~      Study hypotheses :~      Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml~     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of~     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®~     in children and adult patients with CF.~      Primary objective :~      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by~     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®~   "
131260|NCT01337193|"~     The overall purpose of this research is to determine the effect of ultrasound imaging~     biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women~     with stress urinary incontinence. This study will include women 20 years or older with~     stress urinary incontinence.~      The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using~     transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone~     (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks.~     Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide~     biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.~      All participants involved in the study will complete a general medical information~     questionnaire. In addition, all participants will have their PFM contraction assessed using~     an ultrasound machine placed over the lower abdomen, quality of life assessed with a written~     questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at~     completion of the study.~   "
131261|NCT01337180|"~     Exposure to noxious gases and particles is associated with an increased prevalence of~     respiratory and cardiovascular diseases. Thus, investigation of possible airway inflammation~     and/or systemic inflammation in workers exposed to high levels of dust is important. Silicon~     Carbide (SiC) Processing Inc. provides cutting fluid (slurry) for the production of solar~     cells and is at present the largest provider of slurry to the solar industry worldwide. In~     the production process, the recyclable materials (SiC), polyethylene glycol (PEG)) of the~     used slurry are recovered. The airborne exposure consists mainly of SiC (dust particles) and~     evaporation from the recycling of PEG. High levels of dust have been measured and, seventeen~     per cent of the measurements in the processing hall were equal to or higher than the~     Norwegian occupational exposure limit. Thus, assessment of possible systemic and airway~     effects of this exposure is of interest. A prospective design will be applied and the~     effects studied by means of registration of respiratory symptoms, spirometry, nitric oxide~     (NO) in exhaled air, induced sputum and blood sampling over a 3 year period. Exposed~     subjects will also be compare with non- or low exposed subjects (administrative/office~     workers). Efforts will be made to include all eligible subjects and to avoid drop-outs. If~     early signs of airway or systemic inflammation in workers or in cells are demonstrated in~     the study, it will be necessary to implement measures to reduce the exposure levels.~      The primary aim of the present study of workers exposed to Silicon Carbide dust in the~     workplace is to determine whether this exposure is associated with inflammatory changes in~     the lungs.~      The secondary aims are: - to examine possible changes in systemic inflammatory markers and -~     to examine changes in lung function among Silicon Carbide processing workers during a period~     of 3 years. Possible changes in lung function will be monitored by spirometry and gas~     diffusion measurements (study A). Airway inflammatory responses and changes in circulating~     inflammatory markers will be assessed by examination of the induced sputum samples and blood~     samples every 6th month in a subgroup of workers (study B).~   "
131262|NCT01337167|"~     This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when~     administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of~     DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether~     subjects who receive V419 have a similar immune response to the vaccine compared to subjects~     who receive licensed component vaccine controls.~   "
131263|NCT01337154|"~     The goal of this study is to determine the progression-free survival and objective response~     rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who~     are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or~     placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as~     twice daily orally, or an equal number of matching placebo tablets, starting 1 week before~     chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for~     response on Day 50, Day 113, then every other month using the Response Evaluation Criteria~     in Solid Tumors (RECIST 1.1).~   "
131264|NCT01337141|"~     A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team~     increases the possibilities to improve metabolic control. The support of telematic visits~     can support the patient and the health system.~      Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes~     mellitus (DM1) candidates for improved metabolic control selected according to inclusion and~     exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor~     Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate~     contribution and other events via the internet. Both the patient and the professional can~     use this information via the telecare system platform.~      Work hypothesis~      The application of interactive telematic systems between patient-health team will improve~     the cost effectiveness of care programmes for optimisation of metabolic control directed~     towards diabetes mellitus (DM1) patients.~      Objectives:~      General Objective Evaluate the impact of the telecare system on the efficiency of economic~     and clinical management of human and material resources directed to a program of metabolic~     control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic~     control and the quality of life of the patients.~      Specific objectives~        1. To identify and analyse the influence of the telecare system on patient costs in time,~          money and normal work or school activity which the patient has to stop to carry out the~          physical visits for following the programme.~        2. To identify and analyse the influence of the telecare system on medical team costs in~          time, money and care organisation directed towards the monitoring phase of the~          metabolic control care programme.~        3. To identify and analyse the influence of the telecare system on the level of metabolic~          control: Glycosylated haemoglobin and the presence of acute hypoglycemic and~          hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the~          metabolic optimisation programme.~        4. To identify and analyse the influence of the telecare system on the quality of life of~          the patient measured in satisfaction scale, impact, social/work concern and concern~          relating to diabetes.~        5. To identify and analyse the influence of the telecare system on the adherence to~          different treatment components.~   "
131265|NCT01337128|"~     In this prospective study, patients with carotid stenosis will be randomly assigned to one~     of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)).~     Pre- and postoperative neuropsychological functions, levels of several biomarkers and~     intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will~     also be gathered. The mix of these data will allow us to answer several questions regarding~     the absence or presence of preoperative impairments, postoperative changes in cognitive~     performance and possible differences between CEA and CAS regarding postoperative~     neuropsychological functions. The use of a matched control group and implementation of a~     long term follow-up will contribute to the uniqueness of this study. It will meet several~     flaws of previous studies and will complete the ongoing randomized studies comparing CEA and~     CAS that are lacking neuropsychological data.~   "
131266|NCT01337115|"~     The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to~     a continuous femoral nerve block (CFNB) improves post-operative analgesia after knee~     arthroplasty.~   "
131267|NCT01337102|"~     In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal~     for oncologists and their patients. In order to achieve this goal, some form of systematic~     and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of~     advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated~     site-specific QoL measure designed for use in patients with lung cancer undergoing~     treatment. Recently it has been developed into an electronic form that uses a hand-held~     pocket personal computer (pc) to enhance collection and presentation of QoL assessments into~     clinical trials and patient care. This study will evaluate the impact of this~     computer-generated QoL (LCSS-QL) assessment on treatment practices for advanced lung cancer~     patients using a randomized trial design. The investigators hypothesize that a~     Computer-Generated Quality of Life Assessment Program will positively impact treatment~     patterns for patients with lung cancer.~      Specifically, the investigators hypothesize:~        1. Use of the LCSS-QL will increase and accelerate referral to and use of palliative care~          services;~        2. Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with~          earlier identification of lack of benefit in some patients;~        3. Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor~          response as an indicator of treatment benefit.~      Maximizing quality of life is one of the most important goals of palliative chemotherapy in~     the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to~     improve palliative management of these patients, including optimizing duration of~     chemotherapy and use of palliative and supportive services based on patient QoL response,~     this will dramatically improve the quality of care provided to advanced lung cancer~     patients. This study will also provide a springboard for other ways to incorporate~     computer-generated QoL measurement in treatment decision-making in advanced cancer patients,~     including in other tumor types such as advanced breast and colorectal cancer.~   "
131270|NCT01337063|"~     Patients often have problems after they leave the hospital, in part because errors are made~     in the medications they are prescribed. The goal of this project is to develop a more~     accurate and safe medication prescription process when patients enter and leave the hospital~     and implement this process at six U.S. hospitals. The investigators will measure the success~     of the project and develop lessons learned so this process can be applied to other~     hospitals.~   "
131271|NCT01337050|"~     This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with~     dose escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended~     Phase 2 Dose [RP2D].~   "
131272|NCT01337037|"~     The purpose of this study is to modify the surgical technique of VATS (video-assisted~     thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.~   "
131273|NCT01337024|"~     Heart rate variability (HRV) is an important indicator of cardiac autonomic function and~     predictor of cardiac mortality and of all-cause mortality. In this study the investigators~     examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO)~     undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).~   "
131274|NCT01337011|"~     This is a pilot study comparing the effect of intra-coronary versus intramyocardial~     application of enriched CD133pos autologous bone marrow derived stem cells for improving~     left ventricular function in chronic ischemic cardiomyopathy.~   "
131275|NCT01336998|"~     Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful~     marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker~     for necrotizing enterocolitis (NEC).~      NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered~     mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major~     factors thought to play an important role include an immature intestine ,an inflammatory~     response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion~     injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple~     laboratory test to differentiate NEC at an early stage from other conditions in the neonate.~      Arginine is the substrate for NO production in the gut and its deficiency may cause~     vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine~     supplementation was found to reduce the incidence of NEC in premature infants but more~     studies are needed for the use of arginine supplementation for the prevention of NEC.~      The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW)~     infants during the first month of life as an inflammatory marker of the bowel and evaluate~     whether premature infants receiving arginine supplements had lower calprotectin values~     compared to the premature infants that did not .~      The investigators hypothesize that arginine supplementation in preterm infants reduces the~     inflammation of the gut which will be shown by the lower fecal calprotectin values of the~     premature infants receiving arginine supplementation.~   "
131276|NCT01336985|"~     Background:~        -  Cancers in other parts of the body often spread to the liver, developing tumors which~          in many instances cannot be removed with surgery. Liver chemoembolization is a~          treatment that is routinely performed to control liver tumors in those who cannot have~          surgery. It has been shown to prolong survival, but does not cure the cancer. During~          chemoembolization very tiny beads (drug-eluting beads, or DEB) containing chemotherapy~          drugs (usually doxorubicin) are administered directly into the blood vessels of a liver~          tumor. The drug within the beads is then released into the tumor whilethe beads~          temporarily interrupt the tumor s blood supply.~        -  Irinotecan, a drug commonly given intravenously to treat colon cancer, has been given~          in chemoembolization procedures in four other studies that have shown that the~          treatment is generally well tolerated. Researchers are interested in determining~          whether giving the drug irinotecan directly into the liver using drug-eluting beads is~          not only well tolerated but also provides a larger dose directly to the tumor as~          determined by tumor and normal liver tissue biopsies. The liver biopsies are an~          optional portion of the study.~      Objectives:~      - To evaluate the safety and effectiveness of chemoembolization with irinotecan for tumors~     caused by cancer that has spread to the liver.~      Eligibility:~      - Individuals at least 18 years of age who have melanoma, colon, or another intra-abdominal~     cancer that has spread to the liver.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, tumor imaging studies, and liver biopsies.~        -  Participants will receive up to 3 DEB chemoembolization treatments about 6 weeks apart.~        -  After two treatments, participants will have imaging studies to see if the tumors have~          shrunk, and those whose tumors have shrunk may have a third treatment.~        -  Multiple liver biopsies may be performed and blood samples will be taken to determine~          how much drug is in the tumor and the circulation, and to see how the tumor reacts to~          the drug.~        -  Participants will return for followup visits for up to 1 year.~   "
131277|NCT01336972|"~     The purpose of the trial is to determine the short-term effects of dose regimens of~     tolvaptan studied in patients with autosomal dominant polycystic kidney disease (ADPKD) at~     various levels of renal function.~   "
131278|NCT01336959|"~     This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients~     undergoing cardiac surgery with cardiopulmonary bypass.~   "
131279|NCT01336946|"~     Overweight and obesity have become a serious global public health problem and the prevalence~     of these conditions is even higher among persons with mental disorders, compared with the~     general population. Overweight and obesity are partially associated with sedentary~     lifestyles and unhealthy eating habits.~      The aim of the study is to examine the effectiveness and cost-effectiveness of a health~     promotion intervention targeting physical activity and eating habits in persons with mental~     disorders.~      The study hypothesis is that between baseline and the end of the intervention, and after a~     6-month follow up period, significant differences in the primary and secondary outcomes~     between the intervention and control group will be identified. The investigators also~     hypothesize that the health promotion intervention will be cost-effective.~   "
131280|NCT01336933|"~     This phase II trial studies how well combination chemotherapy and pralatrexate works in~     treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing~   "
131281|NCT01336920|"~     This phase I trial studies the side effects and best dose of carfilzomib in treating~     patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
131282|NCT01336907|"~     The FORESEE HOME is intended for the early detection of central and paracentral~     irregularities (abnormalities) in the visual field, most commonly associated with Age~     Related Macular Degeneration (AMD). However, the device has the ability to detect the~     development of the lesion post treatment and therefore to assess in determination of the~     next treatment.~      The Optical Coherence Tomography (OCT) may be used as well to identify choroidal~     neovascularization (CNV). Comparison between the two methods will allow better understanding~     of both devices.~      The FORESEE HOME can be used as an assessment tool for the progression and success of the~     treatment given to AMD lesions. Therefore, evaluating the size and the location of the~     treated lesions may serve as an additional tool.~   "
131283|NCT01336894|"~     RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment~     for non-small cell lung cancer. Internal radiation uses radioactive material placed directly~     into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to~     send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet~     known whether stereotactic body radiation therapy is more effective than surgery with or~     without internal radiation therapy in treating non-small cell lung cancer.~      PURPOSE: This randomized phase III trial is studying how well surgery with or without~     internal radiation therapy works compared with stereotactic body radiation therapy in~     treating patients with high-risk stage IA or stage IB non-small cell lung cancer.~   "
131284|NCT01336881|"~     This research trial is studying biomarkers in tissue samples from young patients with liver~     cancer. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~   "
131285|NCT01336855|"~     This study seeks to confidentially collect blood from HIV-positive individuals and~     HIV-negative controls to provide basic scientists with specimens for collaborative studies.~   "
131286|NCT01336842|"~     The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed~     can be used safely without increasing side effects and that the combination will have a~     better effect than platinum-based doublet chemotherapy alone.~   "
131287|NCT01336829|"~     The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is~     absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed~     into the body when administered together.~   "
131288|NCT01336816|"~     This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver~     Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the~     smoker when tobacco is smoked.~   "
131289|NCT01336803|"~     This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with~     ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors~     to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help~     in diagnosing patients correctly and may result in more timely treatment.~   "
131290|NCT01336790|"~     The purpose of the National Lymphatic Disease and Lymphedema Registry is to collect health~     information in order to study the disease classification, natural history, and impact of~     Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.~   "
131291|NCT01336777|"~     The biological basis for insulin resistance associated with obesity is unknown. By studying~     equally-overweight/obese individuals who are either insulin resistant or insulin sensitive,~     the investigators will compare characteristics of fat tissue to test several hypotheses: 1)~     impaired differentiation and fat storage in the subcutaneous fat depot characterize insulin~     resistant individuals, who have, as a result, fat in other tissues like liver and muscle, as~     well as more fat circulating in the blood; 2) inflammation is greater in visceral and/or~     subcutaneous adipose tissue depots in insulin resistant individuals as compared with insulin~     sensitive individuals.~   "
131292|NCT01336764|"~     Many U.S. military personnel are returning from Operation Enduring Freedom/Operation Iraqi~     Freedom (OEF/OIF) deployments with histories of trauma while driving in military vehicles.~     The proposed project aims to develop and test a rehabilitative technology aimed at enhancing~     emotion regulation and reducing operator-related risk during civilian driving.~   "
131293|NCT01336751|"~     Study Primary Objectives:~      To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine~     and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in~     subjects who failed oral combination therapy with sulfonylurea and metformin.~      Study Secondary Objectives :~      To compare the following measures between subjects receiving insulin glargine or 75% insulin~     lispro protamine suspension/25% insulin lispro:~        -  Incidence of hypoglycemia~        -  Change in weight~        -  Change in serum lipid profile~        -  Percentage of subjects achieving A1C levels ≤7%~   "
131294|NCT01336738|"~     B2611002 is designed to study how safe and effective an investigational medication~     (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5~     treatments for 3 months. One of the treatments will be sitagliptin which is an approved~     drug, and another treatment will be placebo, which does not contain active ingredient.~   "
131295|NCT01336725|"~     The purpose of this study is to determine whether the participants have improved their~     scores on health related quality of life (HRQL) 1 year after completing a learning and~     mastery course and whether sociodemographic variables are associated with HRQL.~   "
131296|NCT01336712|"~     In this study, patients will receive a myeloablative preparative regimen consisting of~     fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized~     peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All~     patients will receive post-transplant Cy in addition to standard post transplant~     immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially~     identical to the prior study, with the exception of the substitution of TBI for Busulfan.~     The investigators hypothesize that this change will significantly reduce the risk of HC,~     while maintaining the efficacy of the transplant.~   "
131297|NCT01336699|"~     Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of~     single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age~     (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective~     is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity~     of clinical signs and symptoms. A secondary objective is to evaluate the immune response in~     blood and stool following ingestion of WRSs2 and WRSs3.~   "
131298|NCT01336686|"~     The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to~     placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in~     patients with gout.~   "
131299|NCT01336673|"~     This is a non-interventional, prospective study where no visits or additional interventions~     to the daily practice of the physician will be performed. Glucophage XR® has recently been~     available in Thailand for the treatment of patients with type 2 diabetes. A prospective~     observational study will be valuable to provide information on the day-to-day experience of~     using Glucophage XR® in the management of this patient population. The data may provide an~     insight into the use of Glucophage XR® in routine clinical practice in Thailand.~   "
131300|NCT01336660|"~     This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the~     treatment of North Africa and Middle East scorpions envenomation by reducing the severity of~     envenomation. The primary endpoint is make a comparison between antivenom and placebo~     groups, at 4 hours after study drug, of the number of cases showing improvement in class of~     envenomation.~   "
131301|NCT01336647|"~     Phase 2 study to assess the safety and effectiveness of a product to treat children and~     adults with head lice~   "
131302|NCT01336634|"~     Dabrafenib is a potent and selective inhibitor of BRAF kinase activity. This is a Phase II,~     non-randomized, open-label study to assess the efficacy, safety, and tolerability of~     dabrafenib administered as a single agent and in combination with trametinib in stage IV~     disease to subjects with BRAF mutant advanced non-small cell lung cancer. Subjects will~     receive dabrafenib 150 mg twice daily (BID) in monotherapy treatment and dabrafenib 150 mg~     bid and trametinib 2 mg once daily in combination therapy and continue on treatment until~     disease progression, death, or unacceptable adverse event.~   "
131303|NCT01336621|"~     The purpose of this Phase III study is to assess the long-term safety, tolerability and~     efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult~     subjects with partial-onset seizures. In addition, those subjects who successfully completed~     20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who~     were thought to have benefitted from treatment will be provided continued access to~     retigabine IR.~   "
131304|NCT01336608|"~     The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol~     Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week~     treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.~   "
131305|NCT01336595|"~     The purpose of this study is to determine if there are any clinical or radiographic~     differences in cemented total knee arthroplasty with an oxidized zirconium and a~     cobalt-chromium femoral knee component.~   "
131306|NCT01336582|"~     Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel~     formulations in terms of AUC and Cmax.~   "
131307|NCT01336569|"~     The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering~     efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with~     open-angle glaucoma or ocular hypertension.~   "
131308|NCT01336556|"~     Background: The oral appliances have been increasingly used in the treatment of primary~     snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment~     options in adults with moderate to severe sleep apnea who did not accept or adapt to~     continuous positive airway pressure (CPAP). It is not well established yet in the~     literature, which patients with mild to moderate OSA will present a good response to~     treatment with oral appliances.~      Objective: To determine a value of CPAP pressure that correlates with a favorable response~     to the use of oral appliance in patients with mild to moderate sleep apnea.~      Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35~     kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15~     events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of~     sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP~     titration, after two months of treatment with oral appliance). Subjective (sleep disorders~     questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective~     (polysomnography) parameters of sleep will be evaluated, besides the quality of life~     (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial~     characteristic). Good response to treatment with the AIO will be considered as a 50%~     reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of~     sleep.~   "
131309|NCT01336543|"~     This is a pilot phase II study of histology based consolidation chemotherapy in patients~     with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent~     chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard~     concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be~     offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of~     consolidation with gemcitabine.~   "
131310|NCT01336530|"~     This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre~     trial with 4 parallel treatment groups. The design is adaptive group-sequential with two~     interim analyses, possible sample size re-estimation after the first or second interim~     analysis and drop-the-loser approach. The study design was primarily chosen to show superior~     efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety~     is a secondary objective.~   "
131311|NCT01336517|"~     The main purpose of this investigation is to evaluate the effect of a lower leg brace on~     walking efficiency and community walking in people who have weakness in one side of the body~     caused after a stroke. The evaluation will consist of several tests that will evaluate~     movement, tightness, balance and sensation in affected leg.~   "
131312|NCT01336478|"~     The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of~     NK cells that will be selected from sibling donors and infused to patients with~     hematological malignancies early following allogeneic stem cell transplantation.~   "
131313|NCT01336465|"~     This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to~     evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe~     ulcerative colitis.~   "
131323|NCT01336335|"~     Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular~     disease even in the absence of hypertension. However, there are few data regarding the~     impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well~     as the impact of treatment with continuous positive airway pressure in different sites of~     activation (heart, peripheral nerves and circulating catecholamines)~   "
131324|NCT01336322|"~     The goal of the present research is to compare the effects of treatment with metformin and~     sitagliptin, alone or in association, in women with previous gestational diabetes to~     evaluate the impact of the two drugs on beta-cell function. The study results may contribute~     to give a rational approach for future investigations.~   "
131627|NCT01332370|"~     This retrospective database study analyzed resource utilization and costs associated with~     sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET)~     monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a~     large US healthcare plan.~   "
131314|NCT01336452|"~     Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause~     of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United~     States and is expected to continue to increase during the next 2 to 3 decades. The expected~     survival rate is still decimal, especially in patients with advanced HCC. However, in recent~     years, several treatment methods for patients with advanced HCC, including antiangiogenic~     chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial~     chemoembolization, have been developed. Among these new treatment methods, concurrent~     chemoradiotherapy has also proved to increase patient's survival rate. It is important to~     predict treatment response before treatment or immediately after treatment because there are~     several other treatment options as mentioned above. Recently, there have been several~     reports that MR perfusion parameters such as Ktrans can predict treatment response in~     cervical cancer and colorectal cancer. Therefore the purpose of the investigators study is~     to evaluate the feasibility of predicting treatment response by MR perfusion, contrast~     enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with~     advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.~   "
131315|NCT01336439|"~     The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on~     bruxism using polysomnography and determine which site is most appropriate for injection to~     obtain maximal effects.~   "
131316|NCT01336426|"~     Purpose~      This study is to verify and validate PAD1 as a qualitative serum test which will combine the~     results of multiple assays into a single numeric result, to be determined by evaluation of~     the study data.~      PAD1 is an automated software device (PADCalc) that incorporates specific and multiple~     biomarker values found in human blood, and generates a score (PAD1 score) using a fixed~     formula implemented within the PADCalc software. The PAD1 score is a result with a high or~     low probability of PAD.~      PAD1 will be submitted to FDA as a 510(k) for in vitro diagnostic use in conjunction with~     clinical assessment, based on factors such as age, diabetes, smoking, and vascular~     laboratory tests (including the ABI), as an aid towards further evaluation of patients who~     meet the enrollment eligilbility criteria.~      Eligibility It is indicated for women and men considered at risk for PAD who meet the~     following criteria: a history of smoking and/or diabetes and are age 50 years or older, or~     70 years of age or older. PAD1 is an aid to further assess the likelihood of the presence of~     PAD when used in conjunction with clinical assessment and vascular laboratory tests.~   "
131317|NCT01336413|"~     Purpose: Mild traumatic brain injury (TBI) is extremely common among OEF/OIF (Operation~     Enduring Freedom/Operation Iraqi Freedom) era Veterans. Mild TBI is frequently accompanied~     by post-traumatic stress disorder (PTSD) and depression symptoms, co-occurring disorders~     that contribute to increased disability and decreased quality of life. Neuroactive steroids~     (NS) represent promising pharmacological candidates for intervention for these diverse~     symptom domains, since a number of these molecules demonstrate pronounced neuroprotective~     and neurotrophic properties. The NS pregnenolone (PREG) is a logical therapeutic option,~     since it enhances learning and memory and also increases myelination in rodent models.~     Further, decreases in PREG have been associated with depressive symptoms, and PREG is also~     metabolized to allopregnanolone (ALLO), an anxiolytic downstream NS that is decreased in~     PTSD. ALLO also enhances neurogenesis in rodents. The investigators thus propose an RCT in~     OEF/OIF era Veterans with mild TBI.~      Methodology: The design of this study will be randomized, placebo-controlled, double-blind.~     Trial duration will be 10 weeks, consisting of a 2-week placebo lead-in period for all~     subjects, followed by 8 weeks of treatment with either pregnenolone or placebo. The primary~     cognitive outcome measure will be executive functioning (as assessed by the Tower of London~     test), and the primary behavioral outcome measure will be PTSD Cluster D symptoms (as~     assessed by the Clinician-Administered PTSD Scale, CAPS). The investigators will also~     determine if PREG administration in OEF/OIF Veterans with mild TBI increases downstream ALLO~     and/or other GABAergic NS levels, and the investigators will identify the specific~     metabolism profile of PREG following eight weeks of treatment with this neurosteroid.~      Anticipated Findings: The investigators hypothesize that treatment with PREG in OEF/OIF era~     Veterans with mild TBI will significantly improve executive functioning compared to the~     placebo condition. The investigators also predict that treatment with PREG will decrease~     Cluster D PTSD symptoms compared to treatment with placebo.~   "
131318|NCT01336400|"~     The investigators previously developed approaches to SNP-, CNV- and haplo-type single human~     cells (Vanneste et al. 2009, Nature Medicine). These methods open the possibility to be~     developed into a novel generic diagnostic technique which broadens the spectrum of~     disease-alleles that can be selected against during preimplantation genetic diagnosis (PGD)~     and which enables to help those couples that cannot be supported by PGD yet. PGD is the~     genetic analysis of a single blastomere from an in vitro fertilized (IVF) embryo and it is~     offered to couples to avoid the transmission of heritable genetic disorders to their~     offspring. PGD analyses are performed for (1) autosomal dominant or recessive monogenic~     diseases, (2) X-linked disorders and (3) chromosomal aberrations that may result in~     aneuploid conceptions. This novel method is likely to outperform and hence, replace current~     techniques for preimplantation genetic diagnosis. In this project the investigators will~     bring the technology from a proof-of-principle to the clinical application. To this end the~     investigators will make computational improvements for accurate single blastomere SNP-, CNV-~     and haplo-typing and perform a large validation study. For the validation studythe~     investigators will analyse the genomes of the blastomeres derived from 60 spare embryos of~     different origin: (1) Embryos diagnosed as genetically abnormal using current PCR- and~     FISH-protocols. (2) Embryos diagnosed as normal for the investigated region using current~     PCR- and FISH-protocols, but not of sufficient quality to be transferred or frozen. (3)~     Embryos of the sex that is selected against following PGD based sex-selection, or embryos of~     the sex that is selected for but of insufficient quality to be transferred or frozen. (4)~     Embryos that were not biopsied in a PGD cycle since they suffer a slight growth delay. This~     validation study will allow us to evaluate (1) the clinical validity (false positive and~     negative rate) and (2) clinical applicability (in terms of ease of use, success rate, etc.).~     In addition, it will bring us essential further fundamental insights in the origins and~     mechanisms of chromosomal instability operating during early embryogenesis and its~     consequences for clinical applications of PGD. Finally, following the validation study, this~     project will clinically implement the technique to treat 10 families.~   "
131319|NCT01336387|"~     This randomized phase I trial studies the side effects and the best dose of retinoid 9cUAB30~     in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from~     forming. The use of retinoid 9cUAB30 may keep cancer from forming.~   "
131320|NCT01336374|"~     The purpose of this study is to determine the impact of vacant lot greening on perceptions~     of safety and violence for residents living around the lots. We hypothesize that people~     living around lots that are greened will have improved perception of safety.~   "
131321|NCT01336361|"~     The purpose of this study is to explore emerging physical therapy practice in palliative~     care, and the perceptions of physical therapists regarding their care of the functionally~     dependent elderly, including: (1) the role and utilization of palliative care intervention~     in current practice, (2) current and potential goal-setting practices which may relate to~     palliative care, and (3) therapists' awareness of cultural and psychosocial issues in~     patient care.~   "
131322|NCT01336348|"~     This is a single-centre, open-label prospective randomized pharmacodynamic investigation of~     2 antiplatelet regimens in patients undergoing coronary intervention for ST segment~     elevation myocardial infarction(STEMI):~        1. Tirofiban bolus only or bolus followed by 2 hour infusion on top of 600 mg clopidogrel~          or 60 mg prasugrel.~        2. Prasugrel given at 60 mg.~   "
131325|NCT01336309|"~     This study comprises 4 phases designed to systematically develop and test a reliable, valid~     and useful quantitative measure of the components and dimensions of yoga; each phase builds~     on the previous phase. Phase I aims to gain a comprehensive understanding of the relevant~     aspects of yoga therapy and develop a large pool of potential questionnaire items by~     conducting a thorough literature review and focus groups with yoga teachers and students.~     These data will be analyzed using rigorous qualitative methods to identify key conceptual~     dimensions associated with yoga interventions. Phase II will develop a prototypic~     questionnaire to assess yoga therapy by refining and honing information from Phase I and~     conducting cognitive interviews to further develop this instrument. Phase III will pilot~     test the measure in a field observation of yoga students and use factor analysis and item~     response theory to select the best items per dimension and to reduce the number of items in~     the measure. Phase IV will collect data on the new instrument and test the psychometric~     properties of the questionnaire (i.e., reliability and validity using data collected in~     Phases III and IV).~   "
131326|NCT01336296|"~     This study is specifically designed to determine whether the initiation of Myfortic 2 weeks~     prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy~     in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to~     Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin~     induction starting at the time of transplant in kidney transplant recipients.~   "
131327|NCT01336283|"~     Aims: To prove the benefits of an specific strength training program in COPD patients~     compared to those achieved with the traditional endurance training. We will assess which is~     the proper training modality and which of them is the most beneficial according to the~     features of the patient to whom it is applied.~      Subjects and Methods: We will study 66 patients diagnosed of COPD with a moderate-severe~     obstruction (FEV1<60%) and clinically symptomatic. The monitoring will be done for 3 moths.~     Patients will be differentiated between COPD with predominant chronic bronchitis and COPD~     with predominant emphysema, with regard to clinical, functional and radiological criteria.~     After stratification of the sample, patients will be prospectively assigned to three groups~     of 22 patients each: a) Endurance training group, on cycle ergometer at a workload of 70%~     VO2max. b) Strength training group, with 5 different weightlifting exercises (4 sets of 6-8~     repetitions). c) Mixed training group, with half the time dedicated to each type of~     training. Training will be developed during 12 weeks, three times per week, in 40 minutes~     sessions. Analysed variables, at the beginning and at the end of program will be: Chest~     X-ray, basic blood analyses, electrocardiogram, simple spirometry and bronchodilator test,~     blood gases, static pulmonary volumes, diffusion measurement and respiratory muscle~     pressure. Muscle strength will be assessed by means of 1RM test and the Myometer®~     dynamometer. Using the muscle skeletal ultrasound, we will control changes in muscle fibre~     size. Maximal and submaximal exercise tests on cycle ergometer will be also performed, so as~     a walking test (shuttle walking test). At last, we will assess treatment effect on dyspnea~     (Mahler`s test) and quality of life (CRDQ).~      Hypothesis: A strength training program would significantly increase peripheral muscle~     power. This type of training would mainly have effect on the predominant emphysema COPD~     patient, where the important weight lost causes a decrease in muscle strength.~   "
131328|NCT01336270|"~     Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate~     with an anti-tumoral specificity. The aim of the study is to analyse at different stages of~     the disease, tumor samples and to characterise the cellular infiltrate in situ ( in~     particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in~     situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.~   "
131329|NCT01336257|"~     Clinical decision support has been shown to improve the performance of screening tests;~     however, few studies have documented direct clinical benefit resulting from the increased~     screening promoted by clinical decision support systems.~      The purpose of this study was to determine if a standards-based, sophisticated decision~     support system could not only promote additional breast cancer screening, but also detect~     significantly more breast cancer~   "
131330|NCT01336244|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and~     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple~     oral administrations.~   "
131331|NCT01336231|"~     Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients~     treated with anti-angiogenic for metastatic kidney cancer~   "
131332|NCT01336218|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib~     when administered alone and with rifampicin in healthy subjects~   "
131333|NCT01336205|"~     The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118~     treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.~   "
131334|NCT01336192|"~     Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death.~     Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer~     (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate~     measure. The standard treatment for this patient population consists of third generation~     platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until~     disease progression (PD) before the administration of second-line and third-line systemic~     anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a~     selected subgroup with an improved overall prognosis.~      Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC~     without PD after first-line chemotherapy has been confirmed to improve progression free~     survival (PFS) and overall survival (OS) significantly compared with placebo in two large~     randomized controlled studies. However, continuation gemcitabine maintenance therapy in this~     setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS~     improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine~     maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1~     and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin~     in China.~   "
131335|NCT01336179|"~     The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and~     the toothbrushes on plaque removal and gingival health.~   "
131336|NCT01336166|"~     The aim of this study is to investigate the long-term immunogenicity and safety of the~     inactivated split-virion vaccine after one immunization.~   "
131337|NCT01336153|"~     To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese~     Medicine on motor recovery after ischemic stroke.~   "
133088|NCT01313312|"~     The purpose of this research study is to assess the long term safety of Dysport in~     hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over~     repeated treatment cycles.~   "
131340|NCT01336114|"~     Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the~     spine. In case of progressive curve deformity, the use of spinal bracing remains the~     standard non operative treatment of moderate AIS. Most of the time, the different types of~     braces don't take into account the individual biomechanical properties of each patient's~     spine. Actually, it is essential to better understand the effect of the loads applied on the~     trunk and on the spine, and a 3D geometrical modelisation of these components is essential.~     Many studies have been publishing concerning the use of radiographs for the geometrical~     reconstruction of the spine, and more recently the EOS system. But even then, it is still~     necessary to obtain an important number of geometrical data and discretisation is still a~     long procedure.~   "
131341|NCT01336101|"~     The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in~     patients with superficial femoral/ popliteal artery disease.~      100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study~     and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which~     time the stent will be placed, and follow-up visits at 6 and 12 months.~      Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will~     be efficacious in patients with Superficial Femoro/Popliteal Artery disease.~   "
131342|NCT01336088|"~     The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in~     Parkinson's disease patients following four weeks of dosing.~      The secondary objectives of the study include the evaluation of the efficacy of ADX48621~     compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's;~     the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient~     ability to function, and the evaluation of the effect of coadministration of ADX48621 on~     L-dopa efficacy.~   "
131343|NCT01336075|"~     The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal~     atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive~     thoracoscopic radiofrequency ablation in patients referred for a first time invasive~     treatment for atrial fibrillation.~      The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time~     invasive treatment is more effective compared to a percutaneous catheter based technique in~     patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at~     least one antiarrhythmic drug.~   "
131344|NCT01336062|"~     Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based~     first-line chemotherapy in China. There was no recommended second-line chemotherapy for~     advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound~     Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer~     in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial~     with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to~     observe the safety and efficacy.~   "
131345|NCT01336049|"~     Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be~     effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma~     have poor prognosis and majority of patients resistant to chemotherapy in China. In the~     investigators phase II clinical trial proceeded before,the combination of paclitaxel with~     cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then~     initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as~     the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety~     of the combination.~   "
131346|NCT01336036|"~     This is a descriptive clinical research aiming:~        -  To describe the clinical spectrum and clinical characteristics of community acquired~          pneumonia (CAP) in patients admitted to hospital~        -  To identify the etiology of CAP and the antibiotic sensitivity of the isolated~          organisms~        -  To identify the risk factors that influence the severity of CAP~   "
131347|NCT01336023|"~     This trial is conducted globally. The aim of this trial is to compare the efficacy and~     safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and~     liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their~     pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.~   "
131348|NCT01336010|"~     To determine whether response guided treatment with pegylated interferon +/- ribavirin is~     effective for the treatment of recently acquired hepatitis C infection. Response guided~     treatment is when the length of treatment is determined by how quickly you respond to the~     treatment.~   "
131349|NCT01335997|"~     This study is being done to find out if tablets containing extended release (ER) niacin,~     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin~     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high~     cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM~     2 g /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing~     low-density lipoprotein cholestrol (LDL-C).~   "
131350|NCT01335984|"~     This is a multi-centered, randomized, parallel group, interventional & open label clinical~     trial accessing efficacy of intervention effect by smart care system over existing treatment~     group for lowering blood pressure of hypertension patients taking anti-hypertension drug.~   "
131351|NCT01335971|"~     Evidence from investigators' group has shown that chronic obstructive pulmonary disease~     (COPD) patients have impairment of antioxidant defenses which are caused by a defect in~     activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous~     vegetables, which is a potent stimulator of Nrf2 activity. The investigators want to~     investigate whether ingestion of sulforaphane by COPD patients will increase Nrf2 activity~     and expression of downstream antioxidants. Accordingly, the investigators are conducting a~     placebo-controlled randomized proof of principle trial of two oral doses of sulforaphane, 25~     and 150 micromoles, for 4 weeks in 90 COPD patients. The investigators' goal is to establish~     a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2, then~     the investigators will have a novel candidate treatment for longer-term efficacy trials.~   "
131352|NCT01335958|"~     This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered~     as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian~     cancer or unresectable pancreatic cancer.~   "
131353|NCT01335945|"~     CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of~     epigastric/abdominal pain associated with pancreatic cancer.~   "
131354|NCT01335932|"~     To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction~     between baseline and 14 days post-randomization) in immunocompetent adults with severe~     sepsis or trauma associated respiratory failure.~      Primary Hypotheses:~      - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV~     reactivation amplifies and perpetuates both lung and systemic inflammation mediated through~     specific cytokines, and contributes to pulmonary injury and multiorgan system failure,~      AND~      - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic~     inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related~     complications.~   "
131355|NCT01335919|"~     The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed~     pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).~   "
131356|NCT01335906|"~     Study objectives: to evaluate the effects of information about benefits and risks of~     mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear~     of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and~     risks of mammography screening increases the women´s knowledge of it; allows women to make~     an informed decision on whether to stop or continue the screening program, changing the~     actual participation rate; anxiety and fear are not increased. Design: randomized controlled~     clinical trial with non-pharmacological intervention. Subjects and setting of study: women~     referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions:~     random assignment of women in two arms according to the information provided. Control arm is~     the standard information; it consists of receiving information normally provided to women~     attending the screening program for breast cancer. Intervention arm is the experimental~     information and consists of receiving accurate verbal and written information about the~     benefits and real risks of mammography screening programs by a physician investigator.~     Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict~     decision.~   "
131357|NCT01335893|"~     Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively~     and imaged using our camera will aid in the identification of a suspected lung nodule.~   "
131358|NCT01335880|"~     This study tests two different incentive mechanisms to induce members of a particular urban~     senior center to attend more exercise classes. Coupons for future use are given to~     participants who attend an exercise class and will be redeemable within either a one week or~     three month time period, depending on which experimental group the participant is assigned~     to. Frequency of exercise class attendance at the end of 2 months will be the primary~     outcome.~   "
131359|NCT01335867|"~     The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug~     and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for~     the treatment of seizures. It has not been proven to be effective for the treatment of~     alcohol or cocaine dependence.~   "
131360|NCT01335854|"~     The proposed research will evaluate new approaches to improving the ability of patients with~     obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive~     airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with~     newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3~     groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care~     with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least~     4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and~     quality of life will evaluate whether patients provided web-based access to their daily CPAP~     adherence with and without financial incentive will have greater objectively measured~     average daily hours of CPAP use and greater improvement in functional outcomes following 3~     months of treatment compared to patients receiving usual care.~      The results will test the hypothesis that these behavioral interventions will improve~     patient adherence to CPAP during the critically important first week of treatment when many~     patients are deciding whether or not to use CPAP and that this initial level of adherence~     will be maintained over the long term despite withdrawal of the financial incentive.~   "
131361|NCT01335841|"~     The purpose of this study is to demonstrate an optimization of the establishment of~     orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and~     navigation system versus conventional method involving anatomical landmarks and 2D~     fluoroscopy.~   "
131362|NCT01335828|"~     Define an ultrasound/elastography benignity criteria in strategy management of a patient~     population carries one or more thyroid nodules.~   "
131363|NCT01335815|"~     Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T~     (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of~     prognosis in patients with elective knee and hip total endoprosthesis.~   "
131364|NCT01335802|"~     Studies have demonstrated a relationship between subclinical hypothyroidism and obstetrics~     complications like preterm delivery, pre-eclampsia, placental abruption and stillbirth.~     Subclinical hypothyroidism and positive thyroperoxidase antibodies (TPOab) may increase the~     risk of early spontaneous abortion before 12 weeks of gestation. But there is not a~     consensus if the prevalence of TPOab should be treated before and during pregnancy when the~     level of thyroid-stimulating hormone (TSH) is normal.~      Thyroid hormones are regulators of the mitochondrial activity and our research group has~     previously shown that subclinical hypothyroidism affects mitochondrial activity.~      The hypothesis:~      Subclinical hypothyroidism causes early spontaneous abortion and or complications in~     pregnancy like pre-eclampsia because of mitochondrial dysfunction~   "
131365|NCT01335789|"~     The purpose of this study is to evaluate how people who frequently use marijuana respond to~     a stressful task, and if a medication (oxytocin) affects this response.~   "
131366|NCT01335776|"~     Sleep disturbance in cancer patients is often overlooked despite its documented high~     prevalence and negative impact. There are few empirically validated non-pharmacological~     treatments for insomnia and many patients are unwilling to rely on sleeping medications.~     This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches~     meditation and yoga) produces equivalent results with the additional benefits of reduced~     stress and mood disturbance, to an already established treatment for insomnia,~     Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for~     insomnia beyond what is currently available and improve quality of life for millions of~     cancer survivors.~   "
131367|NCT01335763|"~     Background: Approximately 1.9 million Canadians are living with diabetes and this is~     estimated to increase by 75% over the next few decades. Pharmacists are front line primary~     healthcare professionals who see patients with diabetes frequently and in Alberta, they have~     been allowed to prescribe medications and order laboratory tests. As such, pharmacists could~     systematically identify poorly controlled diabetes patients and provide greater access to~     diabetes interventions to improve blood sugar control.~      Objective: The aim of this study is to determine the effect of a community pharmacist~     intervention on blood sugar control in individuals with poorly controlled diabetes.~      Project description:~      100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the~     participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c~     test (a blood test to measure individual's blood sugar control over the last 3 months). This~     test requires obtaining a blood spot from the patient which will be obtained by pricking~     his/her fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the~     patient's need for insulin glargine, if the patient needs insulin glargine the pharmacist is~     going to prescribe it for him/her and educate him/her on its use. Patients are going to be~     followed up closely by the pharmacists for 6 months with regular updates to the patients'~     family physicians. This multi-centre study should demonstrate pharmacists' ability to~     improve glycemic control and improve access to care.~   "
131368|NCT01335750|"~     This study is a clinical comparison of the biocompatibility of several multipurpose~     solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution~     among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at~     one research site.~   "
131369|NCT01335737|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads to~     attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.~   "
131370|NCT01335724|"~     The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel~     compared with placebo applied four times a day in subjects with acute neck pain.~   "
131371|NCT01335711|"~     To explore the effect on early viral kinetics and viral load, and to determine safety,~     tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered~     i.m. in combination with electroporation followed by standard of care (SOC) in treatment~     naïve chronic HCV genotype 1 patients.~   "
131372|NCT01335698|"~     The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a~     regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse~     transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.~   "
131373|NCT01335685|"~     This will be a phase 1/2, multicenter, 2-arm, open-label study using the oral formulation of~     IXAZOMIB when added to standard melphalan and prednisone (MP) treatment. Both phases of the~     study will include patients who have newly diagnosed multiple myeloma and are ineligible for~     high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or~     coexisting conditions and for whom standard MP treatment is indicated.~      Note: Phase 2 of the trial will be randomized.~   "
131374|NCT01335672|"~     An estimated three million people are affected by chronic obstructive pulmonary disease~     (COPD) in the UK, giving it a prevalence of 1.5% of the population in 2007/08. COPD accounts~     for approximately 30,000 deaths each year in the UK and is an important co-morbidity in~     those dying from other smoking related diseases, most commonly ischaemic heart disease and~     lung cancer. The National COPD audit showed a very high level of co-morbidity, the~     association with cardiovascular disease being particularly strong with 51% of patients with~     cardiovascular disease having been admitted for COPD within the preceding 24 months.~     Patients with COPD are at increased risk of myocardial infarction compared to the general~     population. Although this increase in cardiovascular risk exists, it is not clear is whether~     survival after myocardial infarction is different in patients with and without COPD and what~     factors contribute to this survival difference. Differences in survival may arise due to~     differences in prescribing certain drugs such as beta-blockers, differences in prevalence of~     risk factors (e.g. current smoking status) or increased COPD events such as exacerbations~     which themselves are associated with increased mortality.~      The investigators primary aim is to investigate whether survival after first myocardial~     infarction is shorter in patients with COPD than those without COPD and to establish reasons~     for these differences in survival.~   "
131375|NCT01335659|"~     The investigators studied the relations between coronary angiography (CAG), intravascular~     ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.~   "
131376|NCT01335646|"~     The objective of this study is to determine if surgery is superior to non-operative care for~     sciatica caused by a lumbar disc herniation. This study will include patients that have had~     severe sciatica for greater than 4 months which reflects the wait time of the Canadian~     health care system. This study is an opportunity to make an important contribution to~     medical science as there is no top tier evidence for or against this highly prevalent~     surgery. Although there have been several recent randomized trials in the field, all have~     been marred by a large number of patient crossing over from non-operative to operative~     treatment. Due to the wait for spine surgery, the Canadian system has a built-in delay that~     prevents such a cross over of patients. This study capitalizes on this unique opportunity to~     perform a high caliber surgical trial. Patients consenting to be in the study will be~     randomly assigned to expedited surgery within three weeks or standardized non-operative care~     while they wait on the surgeons list for consultation and then surgery (minimum wait of 9~     months). The study will assess pain, function, quality of life, satisfaction, and work~     status to determine if one treatment is superior.~   "
131377|NCT01335633|"~     The study will entail cognitive assessment of a single cohort of patients with Multiple~     Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be~     no intervention or control group. Each participant will have a caregiver capable of~     responding to a brief report of observations regarding neuropsychological skills and~     abilities in the patient.~   "
131400|NCT01335334|"~     The proposed open-label one arm before-after clinical trial will assess the efficacy of a~     14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of~     metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and~     20mg of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso,~     Texas. As part of the study we will obtain specimens for culture of H. pylori in a reference~     laboratory.~   "
131378|NCT01335620|"~     This is a phase I, open label, prospective, one phase pharmacokinetic and observational~     study.~      Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be~     receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no~     evidence of previous HIV- resistance mutations on genotypic resistance testing.~      At baseline, subjects will switch antiretroviral therapy to:~        -  tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus~        -  raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24~          hour pharmacokinetic visit.~      Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits~     that will include standard safety parameters. Assessment of cardiac biomarkers at baseline~     and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and~     on day 180 will also be undertaken.~      Following completion of this study, subjects will recommence their usual antiretroviral~     treatment regimen and attend for a study follow up visit.~   "
131379|NCT01335607|"~     The purpose of this study is to:~        -  Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and~          tablet prototype test formulation)~        -  Compare the amount of study drug that is in the blood after taking either the capsule~          form of the drug or the tablet form of the drug while fasting.~        -  Determine the amount of study drug that is in the blood after eating a meal.~        -  Evaluate the safety of the tablet form of samatasvir in healthy people.~   "
131380|NCT01335594|"~     The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is~     associated with deviant pharyngeal swallowing function, using clinical, endoscopical and~     manometric evaluation.~   "
131381|NCT01335581|"~     The purpose of this study is to evaluate the RevLite laser in the treatment of refractory~     mixed type melasma.~   "
131382|NCT01335568|"~     This clinical investigation of the hepatocyte matrix implant is an evaluation blinded~     non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic~     investigation. Randomization is not possible due to ethical and practical reasons. This~     study has already been approved in Switzerland and has been adapted to Indonesian Law and~     disease.~      This new treatment procedure has already been successfully used on the basis of~     compassionate use in Germany. The hepatocyte matrix implant is a new patented procedure~     consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of~     self-dissolving polymers is applied as a carrier substance and is cultivated with human~     autologous cells using a special technique. Clinically the bio artificial liver replacement~     tissue for patients with end-stage hepatic disease has been developed as a first~     application. In this procedure autologous hepatocytic tissue and pancreatic tissue is~     removed (liver resection and pancreatic biopsy) from the patient in a first surgical~     procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is~     GMP certified for this procedure. The cells are processed according to SOPs in a special~     perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm~     diameter and 4mm thickness). After completion of the laboratory process the bio tissues are~     implanted into the mesentery of the small intestine during a second operation. The cells are~     growing controlled on the matrix, take on the capillaries of the patient and thus connect to~     the blood circulation. The implanted cells multiply by a specific factor and independently~     take over the metabolic function of the original liver after two to four weeks. In the~     following process the carrier matrix dissolves completely and implanted cells develop into~     liver cell tissue.~   "
131383|NCT01335555|"~     It is important to assess patients' fitness for major cancer surgery which carries a high~     risk of mortality. Patients with poor heart and lung function have a higher risk of death~     after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure~     of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period~     of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on~     cell function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by~     CPET, prior to major cancer surgery. Participating patients will undergo fitness testing by~     CPET before and after their chemotherapy, prior to their surgery.~   "
131384|NCT01335542|"~     There are 2 common ways to manage pain after total knee arthroplasty at our institution.~     Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More~     recently, some surgeons have replaced femoral nerve blockade with peri-articular injections.~     These patients receive a peri-articular injection (injection of pain medication around the~     knee), pills for pain and a pain patch on the skin. The purpose of this research project is~     to find out if one of these ways to treat pain is better than the other. The investigators~     will look at this question in many ways, but the main way is how long it takes for you to be~     judged ready for discharge from the hospital.~   "
131385|NCT01335529|"~     The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected~     patients are non responders after 48 weeks of the current standard-of-care with~     Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of~     Boceprevir to the current standard-of-care has been shown to increase the efficacy of~     therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that~     HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to~     increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is~     important to improve the response rate of the re-treatment of hepatitis C in these patients.~      The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in~     combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and~     chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects~     will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR)~     defined as undetectable HCV-RNA at Week 24 after the end of therapy.~   "
131386|NCT01335516|"~     Terlipressin is an effective and safe treatment for bleeding caused by rupture of~     oesophageal varices, which are life-threatening complications of liver cirrhosis.~      Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus,~     which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is~     a life-threatening complication with mortality between 20-50%.~      Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy~     consists of a flexible tube equipped with a camera at the terminal end, allowing for~     visualizing and treating the oesophageal varices.~      In this study, investigators will evaluate the safety and efficacy of terlipressin -~     Glypressin 1 mg, powder and solvent for solution for injection.~      The non-interventional observational study Follow-up of Glypressin (terlipressin) clinical~     efficacy in the treatment of bleeding oesophageal varices aims to demonstrate that~     administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.~   "
131387|NCT01335503|"~     The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in~     the stomach and how much gluten enters the small intestine. A second question is whether the~     caloric density of a meal can influence the efficacy of AN-PEP breakdown.~   "
131388|NCT01335490|"~     The purpose of the study is to understand how cooking might affect the health of pregnant~     women and their babies.~      The goal of the research is to determine whether, interventions in decreasing exposure to~     smoke from cook stoves can bring about a significant change in the indoor air pollution~     levels and health of communities in Ghana.~      Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will~     lead to a significant increase in average birth weight in newborns.~      Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate~     of severe acute lower respiratory disease during the first 12 months of life.~   "
131389|NCT01335477|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in~     scarring of the lung and there is a high unmet medical need for effective treatment to halt~     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the~     death rate.~      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of~     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function~     of patients treated with high dose of BIBF 1120 compared to placebo.~      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of~     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial~     will be conducted as a prospective, randomised design with the aim to collect safety and~     efficacy data.~      Respiratory function is globally accepted for assessment of treatment effects in IPF~     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is~     part of the usual examinations done in IPF patients.~   "
131390|NCT01335464|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in~     scarring of the lung and there is a high unmet medical need for effective treatment to halt~     lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the~     death rate.~      In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of~     treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function~     of patients treated with high dose of BIBF 1120 compared to placebo.~      Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of~     BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial~     will be conducted as a prospective, randomised design with the aim to collect safety and~     efficacy data.~      Respiratory function is globally accepted for assessment of treatment effects in IPF~     patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is~     part of the usual examinations done in IPF patients.~   "
131391|NCT01335451|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     AZD5213 in healthy young and elderly Japanese subjects~   "
131392|NCT01335438|"~     The purpose of this study is to determine if there are any clinical or radiographic~     differences in cemented and cementless fixation in total knee replacement.~   "
131393|NCT01335425|"~     In clinical practice language impairment is frequently reported in association with~     nocturnal epileptiform activity. There is a spectrum of epileptic conditions that are~     characterized by nocturnal epileptiform activity. From mild to severe this spectrum~     involves: Rolandic epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner~     syndrome (LKS) and electrical status epilepticus during slow wave sleep (ESES). The exact~     characteristic of the relationship between nocturnal epileptiform activity and language~     impairment is yet to be explored. The investigators suggest that nocturnal epileptiform EEG~     discharges and nocturnal epileptic seizures during development will cause diseased neuronal~     networks that involve language. The diseased neuronal networks are less efficient compared~     with normal neuronal networks.~      Objective: Identification of a diseased neuronal network characteristic in children with~     nocturnal epileptiform activity, which can explain language impairment in these children.~     For this the investigators will use functional magnetic resonance imaging (MRI) to analyse~     brain activity and diffusion weighted MRI to investigate white matter connectivity.~   "
131394|NCT01335412|"~     This is an active electronic surveillance using data from the Defense Medical Surveillance~     System (DMSS) to detect and characterize serious, rare adverse events occurring within 42~     days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military,~     to detect adverse events that occur more frequently after IXIARO and to electronically~     follow up pregnancies during or shortly before which IXIARO was administered.~      There will be no intervention and no individuals contacted.~   "
131395|NCT01335399|"~     The purpose of the study is to determine whether the addition of Elotuzumab to~     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)~   "
131396|NCT01335386|"~     This is a randomised, assessor-blind, multi-centre pilot study to investigate the~     comparative safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of~     constipation in Chinese patients.~   "
131397|NCT01335373|"~     Vaginitis is the most common gynecologic diagnosis in the primary care setting. In~     approximately 90 percent of affected women, this condition occurs secondary to bacterial~     vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.~      Neo-Penotran Forte is registered for treatment of these most common vaginal infections.~     Efficacy and safety of this product is already established, and this observational study was~     designed to learn more about practical use of Neo-Penotran® Forte in real life setting.~   "
131398|NCT01335360|"~     This study would be a prospective cohort study, stratified by weight. Patients who are~     stable on nevirapine for at least 3 months prior to study entry, but no more than 1year will~     be recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic~     (and be observed taking it), and given their evening dose to take at home. Subjects will~     need to record the date and time they take their evening dose. At the end of the week, the~     subjects will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic~     sampling. They will not be brought back in at 24hrs as they will need to be redosed after~     12hrs. They will have Liver Function Tests (LFT's) and other labs drawn at study entry, and~     one month after the end of study. Pharmacokinetic levels will be analyzed using standard~     mathematical models, and Area Under the Curve (AUC), Maximum concentration (Cmax), and~     Minimum Concentration (Cmin) will be compared between groups.~   "
131399|NCT01335347|"~     The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine~     to prevent avian influenza. Volunteers will receive either one or two doses of research~     vaccine or placebo as part of this study.~   "
131402|NCT01335308|"~     BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children.~     Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three~     groups. The first group continued with standard care; in group 2, each practitioner~     delivered four study Motivational Interviewing visits with the parent/caregiver, and in~     group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational~     Interviewing visits. The primary outcome will be the child's percentile BMI change between~     the baseline and 2-year follow-up. Secondary outcomes will include behavior change around~     fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will~     be a larger decrease in BMI percentile for children in group 3 than in group 2, and that~     children in group 2 will have a decrease in BMI percentile when compared to group one.~   "
131403|NCT01335295|"~     Objective of this study is to evaluate safety and tolerability of flavocoxid administered at~     the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in~     association with steroids (deflazacort on alternate days) started at least one year before.~     The investigators will also perform a multidimensional clinical evaluation covering~     functional and muscle strength and quality of life (QoL)assessments.~   "
131404|NCT01335282|"~     Traditional Chinese Medicine (TCM) has a history of more than two millenniums. It has been a~     common practice in China, Taiwan, Japan and Korea and is becoming increasingly popular~     worldwide in recent decades However, there is no general consensus for treatment of many~     diseases among TCM practitioners. In some specialties, such as neurology, there is not~     enough well documented case reports for practitioners to make reference with. Different~     practitioners may give different opinions according to their own experience and patients~     often feel frustrated about that.~      Therefore, it is worth recording cases of neurological diseases, with accurate western~     medicine diagnosis and TCM theory explained. Possible TCM treatments can be suggested~     accordingly. Being an academic research supervised by western medicine doctor, this study~     can help to suggest more objective opinion with least conflict of interest.~   "
131405|NCT01335269|"~     The primary objective of this trial is to determine the safety and tolerability of BI 853520~     monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for~     further trials in the development of this compound.~      Secondary objectives are~        -  determination of the pharmacokinetic (PK) profile;~        -  exploratory pharmacodynamic analysis; and~        -  collection of preliminary data on anti-tumour efficacy.~   "
131406|NCT01335256|"~     Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394~     given in 4 week on / 2 week off schedule to patients with advanced solid tumors~   "
131407|NCT01335243|"~     The main objective of this clinical study is the estimation of the rate of intersomatic~     fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK~     interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous~     substitute with a biomaterial (MatriBONE associated with the autologous bone marrow),~     associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow.~     Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow~     lumbar canal and\or spondylolisthesis.~   "
131408|NCT01335230|"~     The purpose of this research study is to explore what role immune cells within the gut (the~     sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or~     HCV/ HIV co-infection.~   "
131409|NCT01335217|"~     This is a 20-subject, dose finding study to examine the use of external trigeminal nerve~     stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD)~     co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant~     medications. Our primary objective is the examination of TNS in this patient population.~      To accomplish our specific aims, the investigators will test the following specific~     hypotheses:~        1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the~          eight-week period.~        2. Subjects will show improvement in ratings of life functional capacity and quality of~          life with TNS.~        3. Subjects will report the TNS treatments to be acceptable in terms of side effects and~          burden of using the device.~   "
131410|NCT01335204|"~     This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with~     castration-resistant prostate cancer (CRPC). The current study is designed to determine if~     the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or~     overall survival (OS). In addition, the Lead Researcher is requiring the collection of~     urine, and blood specimens for future research.~      This study will enroll patients with CRPC, who have been previously treated with docetaxel~     or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to,~     docetaxel, or may have been previously treated with the agent without definite disease~     progression during therapy.~      Patients must meet the study eligibility criteria and must be competent to give informed~     consent.~   "
131411|NCT01335191|"~     This protocol represents the third in human study of TUTI-16, and is being conducted to~     gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of~     subcutaneously administered TUTI-16.~   "
131412|NCT01335178|"~     The goal of this research project is to develop and evaluate an intervention to reduce young~     child tobacco smoke exposure~   "
131413|NCT01335165|"~     The purpose of this research study is to understand the safety, pharmacokinetics and~     pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV~     (through a vein) or SC (under the skin) to patients with PNH.~   "
131414|NCT01335152|"~     Stress Management interventions have been shown to decrease cancer-related distress, foster~     emotional growth and improve immune functioning during treatment for breast cancer.~      This study will evaluate an online version of a stress management intervention for women~     with early stage breast cancer. Each chapter of the 10-week intervention include~     self-assessment and targeted feedback, education, interactive learning exercises -- all~     tailored to the needs of women with early stage breast cancer. In addition, guided writing~     exercises will promote emotional expression and a discussion board will encourage group~     support.~      The web-based intervention is being evaluated in a randomized clinical trial with a sample~     of 120 women with early stage breast cancer. Women will be randomly assigned to use the~     10-week intervention with biweekly telephone assessments or to the telephone assessments~     alone.~   "
131415|NCT01335139|"~     The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT,~     grass pollen tablets under the tongue) has long term effects in severe hay fever.~   "
131418|NCT01335100|"~     Background:~      Motor impairment limits social and recreational activities in children with cerebral palsy~     (CP), compromising participation and impacting on quality of life. Improvement of motor~     function by medical treatment may advance in participation of outdoor activities and expand~     social and recreational activities. While Botulinum toxin (BTX) injections are effective and~     safe treatment for spasticity in children with CP, there is insufficient evidence for~     improvement of motor function and enhanced participation in this population.~      Objective:~      To examine outdoor activity as a functional outcome following lower limb BTX in children~     with CP.~      Methods:~      In this pilot study the investigators will use Global Positioning Systems (GPS) to measure~     walking speed, distances, number of walking events and destinations in ambulatory children~     with CP following BTX injection to the lower limbs; age and gender matched sibling will be~     studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following~     BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will~     be correlated with leisure activity preferences and quality of life questionnaires.~      Significance: Improvement in outdoor activity following BTX injections in this pilot study~     will assist construction of a larger study evaluating participation and quality of life in~     children with CP.~   "
131419|NCT01335087|"~     OSA may be a modifiable risk factor for cardiovascular disease due to its association with~     hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic~     OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce~     snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure~     and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine~     if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA~     admitted in a hospital for an acute coronary syndrome.~      Overall objective:~      To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical~     evolution of patients with acute coronary syndrome (ACS).~      Primary objectives:~      1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate~     of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial~     infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new~     hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with~     ACS and co-occurring sleep apnea.~      Secondary objectives:~        1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.~        2. Other secondary objectives will include the effects of CPAP on:~             -  To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic~               stroke.~             -  Components of primary composite endpoints~             -  Re-vascularization procedures~             -  To evaluate all-cause death~             -  To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias~             -  To evaluate newly diagnosed diabetes mellitus, according to standard definitions~             -  To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))~             -  To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).~        3. To establish the relationship between the severity and phenotype of patients with OSA~          and clinical outcomes of ACS.~        4. To establish the relationship between CPAP compliance and CV events incidence.~        5. To identify biological risk markers that allow us to establish the most important~          mechanisms involved in cardiovascular complications in these patients.~        6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of~          patients with ACS who have obstructive sleep apnea.~   "
131420|NCT01335074|"~     Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting~     toxicities with the need to reduce the applied dose of the compound. As this limits the~     overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR~     signaling, will be investigated regarding safety and tolerability in patients with advanced~     liver cancer under a reduced dose of sorafenib.~   "
131421|NCT01335061|"~     The purpose of this study will be to determine if a once-weekly prophylaxis regimen of~     BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.~   "
131422|NCT01335048|"~     The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an~     adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable~     patients with high on-treatment reactivity according to a point-of-care platelet function~     assay.~   "
131423|NCT01335035|"~     This study has been designed to establish the efficacy and safety of deferasirox in patients~     with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant~     (HSCT).~      The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of~     treatment with deferasirox, in patients with iron overload (defined with serum ferritin~     levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.~   "
131424|NCT01335022|"~     The investigators seek to demonstrate that interactive physician-led education through~     partnership with an African American church will improve awareness and knowledge of~     cardiovascular disease in the African American community and will result in objective~     improvement in major risk factors associated with cardiovascular disease (CVD).~   "
131425|NCT01335009|"~     This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess~     progression free survival in subjects with metastatic melanoma.~      80+ subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into~     one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease~     progression.~      Subjects must have measurable disease by CT Scan or MRI and must have completed at least one~     prior round of chemotherapy.~      Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse~     Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical~     exams/vital signs, tolerability).~   "
131426|NCT01334996|"~     In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic~     agent, to improve quality of life, biochemical parameters, and bone marrow involvement in~     systemic mastocytosis patients having 1) up to 20% bone marrow infiltration by mast cells~     and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard~     non-cytotoxic medications regardless of the percentage bone marrow involvement by~     mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be~     for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine~     will be excluded until these medications have been stopped.~   "
131427|NCT01334983|"~     The purpose of this study is to determine whether a gentle physical conditioning program~     comprised of isotonic resistive strengthening and pedometer-directed walking can improve the~     physical functioning and fatigue of patients with late stage lung or colon cancer.~   "
131428|NCT01334957|"~     The primary objective of this study is to determine the safety of a single dose of~     intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of~     postoperative pain.~   "
131429|NCT01334944|"~     The primary objective of this study is to determine the safety of a single dose of~     intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in~     the hospital setting.~   "
131602|NCT01332695|"~     This study will look at the ability of ST101 to treat symptoms in subjects with Essential~     Tremor. This study will also examine the safety and tolerability of the drug. This study is~     evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that~     all patients will receive both ST101 and placebo, but they will receive it in a random (by~     chance) order.~   "
131430|NCT01334931|"~     Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of~     this study is to evaluate the routine use of large field of view during image acquisition~     for coronary angiography. Patients with indication of diagnostic coronary angiography will~     be randomized for the use of either large field of view during image acquisition or medium~     field of view. Patients, physician and nurse radiation exposure will be measured by digital~     dosimeter.~   "
131431|NCT01334918|"~     The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single~     Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with~     regadenoson in order to detect the presence or absence of reversible defects.~   "
131432|NCT01334905|"~     The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the~     pharmacokinetics of YM178 in healthy adult subjects.~   "
131433|NCT01334892|"~     Immunosuppression is a key intervention in patients with solid organ transplant and is~     usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine,~     mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation~     are poor when compared with those after heart, kidney, or liver transplantation, with a~     survival rate of only 55% for recipients of lung transplants.~      Additional application of aerosolised L-CsA should suppress T-cell activation in the lung~     tissue and subsequently BOS development. The overall purpose of this phase-II/III study is~     to obtain efficacy and safety data of L-CsA in the prevention of BOS.~   "
131434|NCT01334879|"~     This study investigates the use of a high dose anti-VEGF agent for the treatment of~     radiation retinopathy in those patients who have recalcitrant disease.~   "
131435|NCT01334866|"~     This clinical study has been developed to evaluate the clinical outcomes in patients~     undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a~     minimally invasive coronary bypass procedure that is done on a beating heart via a smaller~     chest incision, thus avoiding the invasiveness of the standard procedure.~   "
131436|NCT01334853|"~     The rationale for conducting this study is to explore potential clinical and peripheral~     biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for~     persistent asthma~   "
131437|NCT01334840|"~     Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated~     mineral waters are reported to have beneficial digestive and hypocholesterolemic properties.~     The aim of this study was to investigate the effects of the consumption of a~     sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral~     content water as a control water (CW), on postprandial serum triacylglycerols (TAG),~     cholecystokinin (CCK), and gallbladder volume.~   "
131438|NCT01334827|"~     The purpose of the study is to compare, contrast, and characterize the range of user~     perceptions and potential acceptability of three (3) topical vaginal microbicide dosage~     forms.~   "
131439|NCT01334814|"~     The proposed study is a randomized, single blind trial of intermittent versus continuous~     stimulation among essential tremor (ET) patients with a chronic history of continuous~     stimulation.~   "
131440|NCT01334801|"~     This study is being done to determine whether or not new blood test(s) can determine the~     severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral~     regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and~     tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders~     under study. The blood tests involve analysis for von Willebrand Factor antigen and~     activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The~     results of the blood tests will be compared to the information from the clinically-indicated~     echocardiogram and one blood test compared to another.~   "
131441|NCT01334788|"~     Chronic sleep deprivation may constitute an important and potentially correctable behavioral~     factor in the alarming increase in obesity. There are no definitive experimental studies in~     humans showing whether sleep deprivation indeed contributes to increased energy intake~     and/or reduced energy expenditure. The investigators propose a series of novel studies to~     investigate abnormalities in energy homeostasis imparted by sleep deprivation. The~     investigators will measure food intake, energy expenditure (basal metabolic rate, thermal~     effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24~     healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be~     randomized to sleep deprivation. Measurements will be compared to those obtained in 12~     subjects who are randomized to a control group, and are not sleep deprived. The~     investigators will test the following hypotheses: 1. That sleep deprivation results in~     positive energy balance (increased caloric intake and decreased energy expenditure, as~     reflected by decreased non-exercise activity thermogenesis). 2. That dysregulation of~     appetite and energy expenditure is associated with changes in molecules controlling appetite~     and metabolism. 3. That changes associated with 8 days of modest sleep deprivation resolve,~     at least in part, over a 4 day recovery period.~   "
131442|NCT01334775|"~     Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a~     year in 10-20% of patients. Although this is of major concern, early postoperative pain also~     has an important impact on patients and their ability to regain normal work and activities.~     Since inguinal hernia repair is the most frequently performed operation worldwide, a small~     reduction in loss of workdays can already have significant impact on financial issues. As~     for the origin of the pain, it might be the result of local inflammation caused by the mesh~     material, but also by nerve entrapment due to fixation techniques. The development of a new~     mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related~     to fixation techniques used in the open hernia repair procedure according to Lichtenstein.~     Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions~     and surgeons familiarized themselves with the application.~      The investigators would like to conduct a multicentre randomised controlled clinical trial~     to compare the difference in early postoperative pain after unilateral primary inguinal~     hernia repair in males. The procedures will be performed in day surgery. Early postoperative~     pain is defined as the pain during the first month, with a special interest in the first two~     weeks. In addition, the investigators want to measure the possible benefit in terms of time~     to return to work, daily activities, quality of life, operation length, complications and~     long term postoperative pain.~   "
131443|NCT01334762|"~     To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with~     recently surgically treated minimal to mild endometriosis.~   "
131444|NCT01334749|"~     The primary aim of the DEDEMAS (Determinants of Dementia After Stroke) study is to identify~     predictors of post stroke dementia (PSD). A particular focus will be on biological markers~     (neuroimaging, biochemical markers derived from blood) and on interactions between vascular~     and neurodegenerative mechanisms. For this purpose patients with an acute stroke and without~     prior dementia will be followed for 60 months.~      Note: Starting from 01.01.2014 this study is expanded to a multi-centric design funded by~     the German Center for Neurodegenerative Diseases (The DZNE - Mechanisms of Dementia After~     Stroke (DEMDAS) Study). This includes the following study sites: DZNE/München - Institute~     for Stroke and Dementia Research, Klinikum der Universität München (Coordinator);~     DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité; DZNE/Bonn - Klinik und~     Poliklinik für Neurologie, Universitätsklinikum Bonn; DZNE/Göttingen - University Medical~     Center Göttingen; DZNE/Magdeburg - Universitätsklinikum Magdeburg.~   "
131445|NCT01334736|"~     Cigarette smoking is very common in current and former injection drug users and is known to~     cause chronic lung diseases. Quitting smoking is proven to improve the health of people~     addicted to cigarettes. . Little information exists regarding the perceptions and~     characteristics of drug users regarding quitting smoking. Additionally, most programs~     designed to help people quit smoking are not very successful. One reason these programs may~     not work well is because it is difficult to motivate people to quit smoking. New methods of~     motivating changes in behavior include small monetary payments for healthy behavior and~     reporting breathing tests with the concept of lung age, which is the age of an average~     healthy person with similar breathing test results. For example, a health care provider can~     report results as Although you are 50 years old, you have the lungs for a 70 year old. In~     this proposal, the investigators plan to first explore the beliefs and characteristics of~     current and former injection drug users and how they are related to quitting smoking. The~     investigators then plan to study whether the use of two new methods of motivation increases~     the chances that this group will stop smoking.~   "
131446|NCT01334723|"~     This retrospective study aims to quantify the relationship between 5-alpha-reductase~     inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention~     (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the~     economic impact associated with these medical encounters. The Integrated Health Care~     Information Solutions (IHCIS) database will be utilized for this study (2000-2006).~   "
131447|NCT01334710|"~     The purpose of this study is to evaluate the effect of combining a new investigational drug~     (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (Hepatocellular~     cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of~     advanced liver cancer. It works by stopping the growth of new blood vessels around the~     tumor. OSI-906 is an investigational agent that works by inhibiting the effects of a growth~     hormone on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the~     treatment of liver cancer risk not known. The current study will confirm the safety of the~     combination in the first six patients and evaluate the activity of the combination in~     patients with advanced liver cancer.~      In addition, the study will aim at collecting blood samples from patients to evaluate the~     level of OSI-906 in patients receiving the combination of the two drugs. The study also will~     collect samples of the tumor to evaluate for markers that can predict in which patient the~     combination is effective.~   "
131448|NCT01334697|"~     The general aim of the study is to determinate safety, tolerability and early~     pharmacokinetics of cardiotrophin.1 in healthy volunteers.~   "
131449|NCT01334684|"~     Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA)~     expression profiles in white blood cells, predict metformin monotherapy efficacy in patients~     with type 2 diabetes.~   "
131450|NCT01334671|"~     The purpose of this study is to evaluate the clinical effect of intensive statin therapy~     before emergency PCI in patients with STEMI.~   "
131451|NCT01334658|"~     This is a study aimed at evaluating the effectiveness and impact of two intraocular~     irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health~     of the cornea after cataract surgery by phacoemulsification.~   "
131452|NCT01334645|"~     The purpose of this study is to determine whether the combination of copeptine and troponin~     adds diagnosis information to that provided by troponin alone or the combination of troponin~     and myoglobin.~      Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute~     myocardial infarction can be ruled out without prolonged monitoring and serial blood~     sampling.~   "
131453|NCT01334632|"~     Brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at~     1 month and 0% at 6 months, but may be higher with a systematic postoperative neurological~     examination. Indeed, femoral neuropathy after anterior cruciate ligament reconstruction is~     24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an~     electromyogram. Brachial plexus injury may be the consequence of the surgery (direct lesion~     by traction) or the continuous interscalene block. The goal of this study is to define the~     etiology of this postoperative neuropathy.~   "
131454|NCT01334619|"~     The retrograde infraclavicular brachial plexus block has been proved an effective and safe~     approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The~     purpose of this study was to determine the medium effective volume required to produce an~     effective retrograde infraclavicular block using an ultrasound (US)-guided technique.~   "
131455|NCT01334606|"~     The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano~     pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen~     needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking~     one or more single daily injections of greater than 40 units of insulin.~      Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be~     compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of~     each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be~     enrolled so as to allow for pre-specified analysis of this subgroup.~   "
131603|NCT01332682|"~     The purpose of this feasibility study is to examine the safety and effect of resistance~     training on muscle strength, lean body mass, physical functioning, fatigue, and quality of~     life in head and neck cancer patients receiving radiation therapy.~   "
131456|NCT01334593|"~     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and~     rectal) cancer is associated with improved survival, but also adversely affects physical~     fitness, potentially rendering patients unfit for major surgery or increasing the risk of~     adverse outcome (death and serious complications) after major surgery. The investigators aim~     to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively~     measured exercise capacity (fitness).~   "
131457|NCT01334580|"~     This study involves the comparison of two treatment approaches for patients with chronic~     pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an~     integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a~     counseling intervention that addresses opioid dependence only.~   "
131458|NCT01334567|"~     The purpose of this study is to offer subjects from centers in Taiwan who successfully~     complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir~     DF for up to three additional years (144 weeks). Subjects will be followed per local~     standard of care. Serious adverse events (SAEs), drug accountability and patient disposition~     will be recorded.~   "
131459|NCT01334554|"~     Obesity has a greater detrimental impact on the health of African American women than on any~     other racial or gender group. Nearly 80% of African American women are overweight or obese~     in the United States. Hypertension and insulin resistance are more prevalent among African~     American women as compared to men and Caucasians. These conditions put them at increased~     risk for the development of diabetes mellitus and cardiovascular disease.~      Recent studies have reported that a substance named Nitric Oxide (NO)may have some~     beneficial effect on how the body handles blood sugar and blood pressure. Of interest,some~     studies have shown that African Americans have decreased function of NO in their blood~     vessels.~      In this study proposal the investigators will test if increasing NO function with a PDE-5~     inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer~     of the blood vessels in obese African American women.~   "
131460|NCT01334541|"~     The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran~     Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care~     Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan~     VAMC, and Philadelphia VAMC).~   "
131461|NCT01334528|"~     The purpose of this project is to explore the degree to which performance consistency on~     neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation~     Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with~     persistent self-reported symptoms.~   "
131462|NCT01334515|"~     This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works~     when given together with sargramostim and isotretinoin in treating patients with relapsed or~     refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and~     sargramostim work in different ways to stimulate the immune system and stop tumor cells from~     growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more~     tumor cells.~   "
131463|NCT01334502|"~     RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells in~     different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone, work in different ways to stop the growth of cancer cells, either by killing the~     cells or stopping them from dividing. Giving everolimus together with rituximab,~     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill~     more cancer cells.~      PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus~     when given together with rituximab and combination chemotherapy in treating patients with~     newly diagnosed untreated diffuse large B-cell lymphoma.~   "
131464|NCT01334489|"~     Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated~     by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.~   "
131465|NCT01334476|"~     The VISN 19 MIRECC is involved in research concerned with suicide prevention in high risk~     populations (e.g., history of traumatic brain injury, post-traumatic stress disorder);~     Recruitment for future studies will continue with a similar focus. The aim of this protocol~     is for the VISN 19 MIRECC Research Database (V19-MRD), to have a data repository of~     participants for possible recruitment from other studies being conducted at the VISN 19~     MIRECC. The VISN 19 MIRECC conducts numerous research projects under the review of COMIRB~     and the VA R&D.~   "
131466|NCT01334463|"~     1. To determine whether tasks taken from the field of cognitive neuroscience can detect~          and distinguish impairments in executive function above and beyond standard~          neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI),~          b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD~        2. To determine whether performance on these tasks is linked to pertinent psychiatric~          outcomes (e.g. history of suicidality), which is associated with compromised executive~          function and impulsivity.~        3. To determine whether information regarding brain anatomy can provide additional~          information above and beyond behavior performance in distinguishing between these two~          groups.~   "
131467|NCT01334450|"~     Transcranial Magnetic Stimulation (TMS) for treatment of Alzheimer disease.~   "
131519|NCT01333774|"~     It has been recently suggested, that not the diet by itself, but also patient's adherence to~     dietary recommendations and all actions performed to improve dietary compliance, may be a~     significant factor influencing blood glucose control. There are no clinical data on the~     influence of different approaches to dietary advising on the effects of acarbose treatment~     in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study~     was to assess the influence of different approaches to dietary advisory on the effects of~     acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to~     assess the influence of different approaches to dietary advising on the appearance of~     potential adverse events in acarbose treated obese DM patients.~   "
131468|NCT01334437|"~     Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial~     diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary~     diagnostic techniques.~      Test Description: Blood is collected from patients and serum/plasma is tested for the~     presence of CAAA on experimental test kit.~      Objectives: To assess the effectiveness of the CAAA test.~      Target Population:~      The study population will include women that have been diagnosed with suspected ovarian~     cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer~     but verified by pathology/cytology as non-cancers and a control set of blood samples will be~     collected from age matched women with no history of cancer.~      Structure: Women that will be enrolled for the study will be checked for the presence of~     CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the~     physicians in the participating centers for the patient population and to the clinical~     history for the control population.~      Sample Size: The investigators will collect at least 50 patients verified by~     pathology/cytology and for each patient at least two aged matched healthy controls and two~     aged matched suspected but verified as non-cancers. Total amount at least 250 samples.~      (Multi center study, statistical rationale provided below).~      Primary Effectiveness Variables: The effectiveness of the test will be defined by the~     specificity of the test conditionally that the sensitivity is not lower than a pre-defined~     level of 95%.~      Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.~      Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical~     trials. All data will be stored in a protected internet-based database, and any changes of~     the data will be traced and recorded.~   "
131469|NCT01334424|"~     Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic~     surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been~     demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.~     Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent~     antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On~     the basis of this knowledge, the investigators hypothesized that propofol has preventive~     effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic~     radical prostatectomy.~   "
131470|NCT01334411|"~     Aim: To identify examples of surgeons good and poor intraoperative behaviours related to~     safe and efficient surgery.~      Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and~     Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with~     empirical background knowledge of observed surgical behaviour as well as an understanding of~     surgical culture. The knowledge will be used to qualify the interviewguide.~      8 semi-structured group interviews and 3 individual interviews will be conducted and tape~     recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as~     a co-moderator. The groups will contain 4 - 12 participants.~      The interview guide will be developed with a Scottish behavioural marker system as a~     framework, drawing upon the literature as well as the observations. It will contain~     questions regarding leadership, communication, teamwork, situation awareness and decision~     making to facilitate a discussion about surgeons' good and poor behaviours.~      Material: Data will be collected in two hospitals in the capital Region of Denmark,~     Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one~     containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses~     and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus~     groups is included to get the perspectives of the surgeons' team members since international~     studies have demonstrated differences of opinion regarding the perceived quality of teamwork~     amongst operating theatre staff. This study will be the first to build in the opinions of~     the team members into a behavioural marker system. 3 individual interviews with surgeons~     will afterwards conducted in one of the hospitals to get a more in-depth discussion.~      Data analysis and statistics: The interviews will be fully transcribed and analysed using~     qualitative method of systematic text condensation. Power calculations are not relevant in~     this qualitative study. Accepted guidelines state that the number of participants in each~     group should range between 5 and 15 and the data are from two large university hospitals~     receiving different patient categories to ensure a certain representative sample of~     informants.~   "
131471|NCT01334398|"~     The primary goal of the proposed study is to evaluate the efficacy of a replicable~     community-based group intervention, designed to address both general wellness and specific~     TBI health-related issues. Emphasis is placed on goal setting to develop healthy habits,~     utilizing problem solving strategies, learning means of maintaining progress and setting new~     goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy,~     reducing barriers to health promotion, and developing personal resources. A randomized~     wait-list control group design will be used to evaluate the efficacy of the intervention. It~     is hypothesized that individuals with TBI who participate in the intervention group will~     report increased health promoting behaviors, health related self-efficacy, health-related~     quality of life, level of participation, and greater perceived wellness and satisfaction~     with life as compared to the control group.~   "
131472|NCT01334385|"~     Veterans possess significant risk factors for self-directed violence (SDV). For example,~     depressed Veterans are at a greater risk for SDV than the general population. Although~     depressed male Veterans die by suicide at a higher rate than do their female counterparts~     (Zivin et al., 2007), female Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)~     Veterans are at higher risk for depression than males (Seal et al., 2009). Joiner's (2005)~     theory states that suicidal individuals (a) perceive themselves to be unbearable burdens~     onto others; (b) view their efforts at establishing and maintaining social connections as~     having been thwarted or failed; and (c) have developed the ability to engage in SDV due to~     from increased habituation to pain. This two-part study uses semi-structured interviews in~     an effort to determine the extent to which Joiner's theory is applicable to OEF/OIF~     Veterans. Part I of this study, which has been completed, assessed the components of this~     theory among primarily male OEF/OIF Veterans. Part II of this study is assessing this~     theory's components among female OEF/OIF Veterans. Participants were recruited from the~     female OEF/OIF Veteran population receiving services through the Eastern Colorado Health~     Care System (ECHCS). Comparisons across the interview responses will be made to identify~     commonalities among the participants' experiences.~   "
131473|NCT01334372|"~     This investigation is a feasibility study conducted in a VA outpatient treatment setting.~     The study is designed to test the feasibility of implementing a novel way of working with~     suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The~     primary purpose of the proposed project is to determine if it is possible to train~     clinicians working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to~     utilize this therapeutic framework. This project is extremely timely in relation to~     expectations of future increased clinical demands among potentially high-risk Operation~     Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the~     years to come.~   "
131520|NCT01333761|"~     The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green~     (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the~     presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against~     transesophageal echocardiography (TEE) for sensitivity and specificity, as well as~     transcranial doppler (TCD) for positive percent agreement and negative percent agreement.~   "
131521|NCT01333748|"~     The purpose of this study is to determine proportion of patients presented a search allelic~     imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or~     ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes~   "
131522|NCT01333735|"~     The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive~     function in patients aged over 65 and suffering from breast cancer or colon.~   "
131474|NCT01334359|"~     Recent trends have identified decreasing levels of physical activity, fitness, and health in~     preadolescent children. Examining factors, such as physical activity behavior and aerobic~     fitness that positively influence cognitive health of school-age children are important for~     improving school performance, maximizing health, and improving the overall functioning of~     individuals as they progress through the human lifespan. A sample of preadolescent children~     from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month~     afterschool program that focuses on either aerobic exercise or wait-list control group to~     determine the effects of physical activity on basic and applied aspects of cognition.~     Changes in neuroimaging and behavioral indices of cognitive function and performance on~     standardized academic achievement tests of mathematics and reading will be examined as a~     function of participation in the intervention. Preliminary research supports that physical~     activity is positively associated with basic and applied aspects of cognition, with a~     stronger relationship for tasks requiring extensive amounts of executive control. However,~     previous research has mainly focused on older adults, and little research has examined the~     relationship between physical activity and executive control in children. These findings~     will provide lifestyle considerations for children to improve their cognitive health across~     the lifespan.~   "
131475|NCT01334346|"~     The following study proposes to investigate the injury risk associated with the use of a new~     category of running footwear: the minimalist shoe. A group of experienced adult male and~     female runners with neutral foot types will take part in this study. All participants will~     be randomized to receive one of three different shoes: a full minimalist shoe (Vibram~     5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive~     running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes~     to be investigated are pain, footwear perception, and number of injury events.~      The hypothesizes is that participants using the minimalist footwear during their running~     program will experience a reduction in running related pain. A greater degree of footwear~     minimalism will result in a greater reduction in pain (compared to the partial minimalist~     shoe, Nike Free).~   "
131476|NCT01334333|"~     A critical aspect of real-world functioning following kidney transplantation involves how~     adherent individuals are to their medication regimens. Regardless of the possible dangers of~     failing to adhere to anti-rejection medications, such as increased graft rejection, studies~     have reported rates of non-adherence at almost 50% following renal transplant.~      The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser~     University, has previously identified relationships between several potentially important~     cognitive and psychosocial variables, and self-reported medication adherence in renal~     transplant recipients, including depressive symptoms, as well as everyday and traditional~     cognitive functioning [4]. The possibility that changes in dosing regimens for a given~     medication may have an additional impact on medication adherence presents an important issue~     worth further exploration.~      The current study will allow for more thorough delineation of the roles of psychosocial and~     cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition,~     the investigators will assess whether different dosing formulations of tacrolimus impact~     adherence behaviors in renal transplant recipients.~      The proposed research has two primary aims to examine:~        1. To examine the role of cognitive and psychosocial variables in predicting medication~          adherence in renal transplant recipients.~        2. To examine whether different formulations of tacrolimus (once per day dosing versus~          twice per day dosing) will impact medication adherence in renal transplant recipients.~   "
131477|NCT01334320|"~     Controversy over surgical treatment of clinically negative neck in early stage oral squamous~     cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The~     efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the~     subject of clinical debate. Currently the clinically negative patients are treated by one of~     the two main policies: one is elective neck dissection; the other is watchful waiting. The~     objective of this multi-institutional prospective randomized controlled study is to evaluate~     the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients~     with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be~     randomized into two groups: elective neck dissection versus watch and wait. The survival~     rate and the recurrence rate between two groups will be compared. The result of the study~     will give surgeons evidence-based instructions for the management of clinically negative~     neck in patients with cancer of oral cavity.~   "
131478|NCT01334307|"~     The objective of this study is to demonstrate the safety and performance of the PneumRx,~     Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The~     PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.~   "
131479|NCT01334294|"~     ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised~     Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD)~     patients at home by characterizing central and paracentral metamorphopsia . The purpose of~     the current study is to evaluate if, in post-treatment patients, PHP parameters as measured~     with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as~     measured with optical coherence tomography (OCT).~   "
131480|NCT01334281|"~     This study is being done because the study doctor is trying to develop a new test which will~     help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test~     would be used to monitor patients' PRA when doctors are trying to lower it through a process~     known as desensitization. Desensitization lowers high PRA levels and allows patients to~     receive transplants. This is a single center study to evaluate and optimize the use of a new~     laboratory test to detect and measure the immune system's functioning.~   "
131481|NCT01334268|"~     The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9~     months, defined as the difference between the post-procedure minimal lumen diameter (MLD)~     and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System~     compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer~     patient population requiring stent implantation.~   "
131482|NCT01334255|"~     LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of~     iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of~     Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related~     Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).~   "
131484|NCT01334229|"~     Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has~     been shown to reduce fasting and postprandial glucose levels in patients with type 2~     diabetes mainly through incretin hormone-mediated improvements in islet function [13].~     Although clinical studies to date indicate that fasting lipid levels are minimally affected~     by DPP-IV inhibitor treatment [14-16], animal studies suggested that DPP-IV inhibition~     reduce intestinal triglycerides (TG) absorption and apolipoprotein (apo) production [17] and~     increased chylomicron catabolism [18]. Interestingly, a recent study supporting this~     hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal~     triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes [19].~     Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo~     B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that~     sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing~     level of glucagon-like peptide (GLP)-1 [20]. Therefore, the present study was designed to~     examine the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type~     2 diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing~     lipoprotein levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor~     and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.~   "
131485|NCT01334216|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. The investigators will be~     studying whether it can help to support parents in their efforts to quit smoking.~   "
131486|NCT01334203|"~     This study will evaluate the efficacy of ranolazine compared to placebo on duration of~     exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma~     concentration after 12 weeks of treatment in subjects with chronic stable angina and~     coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).~   "
131487|NCT01334190|"~     This will be a non-comparative prospective observational study of women using Zarin as a~     primary method of contraception in Kenya. It will be conducted in close collaboration with~     the Kenya MoH in several MoH-affiliated clinics that have experience with implants and~     sufficient expected flow of implant users per month. The investigators will enroll a total~     of 600 women divided into two cohorts in this one-year prospective study:~        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months~          after enrollment; and~        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months~          after enrollment only if they have complications, medical problems, pregnancy, or want~          to remove the implant~      The main study outcomes are pregnancy, immediate and delayed complications associated with~     insertion or removal, adverse events, early discontinuation and reasons for discontinuation,~     and level of women's satisfaction with Zarin services.~   "
131488|NCT01334177|"~     This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when~     given together with cetuximab in treating patients with locally advanced, recurrent, or~     metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as~     TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells~     from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337~     together with cetuximab may kill more tumor cells.~   "
131489|NCT01334164|"~     The proposed study is designed to test the effectiveness of recovery management checkups for~     women offenders (RMC-WO) released from jail to provide continuity of care immediately upon~     release and to help them manage their long-term recovery. The hypotheses in the first phase~     were: 1)women assigned to RMC (versus control) will a) return to treatment sooner after the~     initial release from jail and b) be more likely to receive treatment in the 90 days after~     release from jail; 2)women who received treatment in the first 90 days post release (vs. no~     treatment) will be more likely to sustain their abstinence through 90 days post release from~     a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who~     maintained their abstinence from any alcohol and other drugs through the first 90 days post~     release (vs. any relapse) will be less likely to have a) unprotected sex, b) commit any~     other illegal activity, and d) be re-incarcerated in jail or prison. In the second phase~     repeated exposure to these efforts on a quarterly basis is expected to further strengthen~     each of these effects.~   "
131490|NCT01334151|"~     The primary objective of this study is to assess the speed of absorption and onset of action~     of BIOD-105 and BIOD-107 and compare them to Humalog®.~   "
131491|NCT01334138|"~     There is strong evidence that our current consumption of salt is the major factor increasing~     blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams~     per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.~      The aims of the present study is to determine if the overconsumption of salt influences the~     bp in patients with uncontrolled hypertension or frequently elevated bp.~      Each study subject will complete questionnaires, and their usual dietary salt intake is~     estimated from food composition on 3 completed food diaries. This is also compared with a~     24-hour urine sample collection.~      Based on these results, the study subject receives personal advice to decrease sodium~     consumption and will change the diet for at least 28 days. During this diet, bp will be~     measured and food diaries will be completed. After the intervention, a questionnaire and a~     24-hour urine sample collection will be collected.~   "
131492|NCT01334125|"~     The significance of this project is to investigate the effects of adjunctive metformin~     therapy in children and adolescents with double diabetes. Double diabetes describes a~     clinical state where an individual possesses features of both type 1 and type 2 diabetes.~     There is a paucity of data on the role of adjunctive metformin therapy in children and~     adolescents with double diabetes. To help fill this knowledge gap, the investigators propose~     a randomized, double-blind, placebo-controlled trial of metformin in double diabetes.~     Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in~     patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or~     metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated~     autoantibodies. This will help determine the safety profile, and efficacy of adjunctive~     metformin therapy in these subjects.~   "
131495|NCT01334086|"~     Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy.~     This study is determining the incidence of vomiting/retching of the standard induction~     chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving~     an antiemetic known as aprepitant.~      The standard frontline chemotherapy for patients with AML consists of cytarabine given as a~     7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on~     days 1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to~     patients for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3~     daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.~      This study will test that the prophylactic use of aprepitant, in addition to the standard~     antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of~     delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen,~     compared to retrospective data using this regimen.~   "
131496|NCT01334073|"~     The aim of the study is to determine the MTD of the combination of everolimus plus axitinib~     in solid tumors, especially RCC.~   "
131497|NCT01334060|"~     The study is not currently recruiting new subjects due to an interruption in funding from~     its sponsors. Efforts are under way to re-establish funding, however, the study is currently~     on-hold pending the outcome of these re-funding efforts. There have been no safety concerns~     identified during the study~      This is an open label, single dose level, phase II study in two patient groups (CML and AML)~     using genetic randomisation. Consented and eligible HLA A2+ve patients will be vaccinated~     with two DNA vaccines and HLA A2 -ve patients will be followed up with molecular monitoring~     only. The objectives are to evaluate: 1) Molecular response following p.DOM-epitope DNA~     vaccination in patients with CML (BCR-ABL, WT1) and AML (WT1) at weeks 4, 8, 12, 16, 20 and~     at months 6, 12, 18 and 24. 2) Time to disease progression, 2 year survival rate (patients~     with AML) 3) Correlation of molecular responses with immunological responses. Primary~     Objective: CML: Molecular response of BCR-ABL. AML: Time to disease progression. Secondary~     Objective: Molecular response of WT1 transcript levels, immune responses to WT1 and DOM,~     Toxicity, CML-Time to disease progression, next treatment and survival, AML-2 year survival,~     overall survival~   "
131498|NCT01334047|"~     In this study the investigators will include patients with relapsed epithelial ovarian~     cancer. In spite of increased rates of complete response to initial chemotherapy, most~     patients with advanced ovarian cancer relapse and succumb to progressive disease.~     Immunotherapy may have potential for consolidation therapy. Dendritic cell vaccine is well~     toleranted in previous studies, with minor side effects and no serious adverse events~     registrated In this study, patients will receive DC-vaccine therapy after response to~     platinum treatment at relapse. The investigtors include patients in good clinical condition~     with no severe symptoms of the disease. If patients relapse during vaccine treatment, they~     will be discontinued from the study.~      The investigators have included hTERT- and survivin mRNA in addition to amplified cancer~     stem cell mRNA in the vaccine.~   "
131499|NCT01334034|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the~     pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as~     tablets in healthy subjects.~   "
131500|NCT01334021|"~     The goal of this research study is find out if researchers can use genetic testing on tumor~     samples to predict if tumors will respond to breast cancer treatments. The tumor sample will~     be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope~     that the activation of these genes may predict if the tumor will be sensitive or resistant~     to routine breast cancer treatments, such as chemotherapy or hormonal therapy.~   "
131501|NCT01334008|"~     Circulating tumor DNA detection and quantification in patients with metastatic choroidal~     melanoma.~   "
131502|NCT01333995|"~     Child undernutrition remains a highly prevalent condition in low and middle income countries~     and a major portion of the global burden of childhood malnutrition is found in South Asia~     with an estimated 74 million children living with chronic malnutrition (stunted growth) in~     this region. This burden of malnutrition accounts for approximately 50% of under five child~     deaths in developing countries. The risk of child death is also related to the severity of~     malnutrition and progressively increases the more the child's growth deviates from WHO~     Growth Standard, e.g. children with height-for-age <-3 Z scores from the standard have a~     four fold increased mortality risk compared to children within one Z score of the growth~     standard mean. Underweight in children for 18.7% of the global disability-adjusted life~     years in children less than five years of age. Childhood malnutrition is a pervasive problem~     in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban~     child populations. An establish approach to promoting appropriate breastfeeding practices is~     through the use of local peer counsellors to provide information and to support to mothers.~     A recent study has conducted on pioneering research on this approach in Bangladesh.. The~     main aim of the study is to use a Cluster Randomized Control Trial (CRCT) to collect~     high-level evidence of whether peer counselling of women to promote appropriate~     breastfeeding and complementary feeding can improve feeding practices, child growth and~     reduce the prevalence of malnutrition in their children.~      The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to~     examine the impact of a peer counselling infant feeding education program starting in the~     third trimester of pregnancy to one year after delivery, to improve child feeding practices,~     child growth and reduce the prevalence of malnutrition in their children. This will result~     in two study groups. The outcome assessments will be made on a cohort of infant-mother dyads~     measured at baseline and at follow up visits because the investigators expect a likely high~     correlation between baseline and follow up outcome measures, thus making this approach the~     most efficient study design. Outcome assessments will be conducted with all the~     mother-infant pairs recruited in the community clusters in the study, with an expected total~     of 1950 mother-infant days (975 in each treatment group). The peer counseling education will~     be offered to eligible pregnant women identified by household surveys over 3 months in each~     community cluster in the intervention group. Using a similar approach to recruitment, a~     cohort of mother-infant dyads, who will receive standard maternal and child health care~     programs, will be identified in the control clusters.~      Data will be collected on anthropometry, feeding practices and hygiene and caring practices~     etc. The investigators will report the results for 2-sided 5% tests for the primary trial~     outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age,~     feeding patterns, and mean nutrient intakes) taking account of the repeated measurements~     within children by using separate mixed models. The investigators will use linear mixed~     models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models~     for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage~     exclusively breastfeeding). It is expected that the publications from this research will~     have substantial impact on child health and will help with the development of public health~     nutrition policies for children in South Asia and will be widely cited.~   "
131503|NCT01333982|"~     More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal~     period), and a substantial proportion of these deaths are due to infections (sepsis).~     According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS),~     the Government of Bangladesh is committed to improve access to quality management of~     neonatal infections. The strategy emphasizes that health service providers at all levels~     acquire the skills for managing sepsis.~      Responding to the recommendations in the National Neonatal Health Strategy, this operations~     research seeks to evaluate alternative approaches for the management of neonatal sepsis in~     the community. The evaluation will focus on assessing intervention coverage, provider~     quality of care, and referral and referral compliance, and will undertake cost-benefit~     analysis of community-based neonatal sepsis management. The programme and evaluation will be~     within the existing health service delivery system in Bangladesh and is thus designed to~     inform the effective scaling up of neonatal sepsis management and contribute to the~     implementation of the NNHS. The interventions to be evaluated will be nested in the~     Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government~     of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs.~      This operations research is being implemented by the Government of Bangladesh in~     collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and~     ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be~     randomly selected for intervention and 10 unions will be comparison. The intervention~     consists of training of community health workers, village doctors and health facility~     workers on managing neonatal sepsis in addition to essential newborn care training. In the~     comparison areas the health workers will only receive essential newborn care training.~      The intervention and evaluation will continue for at least 18 months, with rolling surveys~     and two special surveys at 6 and 12 months into the project. The rolling surveys will look~     at intervention coverage, care-seeking, and referral and referral compliance, while the two~     special surveys will assess provider performance, referral compliance, and quality of care.~     In addition, the investigators will document implementation processes to understand what~     worked and what did not and why.~   "
131504|NCT01333969|"~     The application of a tourniquet for 5 minutes and subsequent reperfusion before actual~     inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases~     the level of local inflammation and therefore postoperative pain in response to reperfusion~     of the ischemic extremity.~   "
131505|NCT01333956|"~     Total knee arthroplasty can cause severe postoperative pain, and patients typically receive~     oral opioid analgesics for over 2 weeks. Side effects of pain management may impair~     participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems~     that pregabalin is very helpful to patients after total knee arthroplasty. However,~     pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low~     doses may not be effective, but use of high doses may increase the incidence and severity of~     side effects.The purpose of this study is to determine which dosage of pregabalin is the~     most effective at reducing pain after knee surgery.~   "
131523|NCT01333722|"~     The primary purpose of this study was to evaluate analgesic efficacy and safety of~     hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate~     to severe pain following bunionectomy.~   "
131524|NCT01333709|"~     The purpose of this study is to determine whether the tailored management of locally~     advanced rectal carcinoma can improve the oncologic and functional outcome.~   "
131506|NCT01333943|"~     Currently, the regional anesthetic standard of care for total knee replacement surgery is~     combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting~     approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which~     is the major nerve controlling the knee joint. The femoral nerve also provides movement and~     sensation. While this regional anesthetic technique offers significant postoperative pain~     relief, it is possible that it may cause muscle weakness and increase patients' recovery~     time. Hence there is a need for an alternative technique, one that may help minimize~     postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps~     muscle.~      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it~     is hypothesized that by blocking or anesthetizing the saphenous nerve with local~     anesthetic closer to where it branches off, the area around and below the knee will feel~     numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function.~      Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength~     will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia~     administration, and on postoperative days 1 and 2. It is hypothesized that patients who~     receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.~   "
131507|NCT01333930|"~     The aims of this study are:~        -  Characterisation of immunological effects of Active O2 vs. placebo after ingestion~          during and post standardised strenuous exercise~        -  Characterisation of safety and tolerability of Active O2 in comparison with placebo~          after ingestion during and post standardised strenuous exercise considering Adverse~          Events observed in the study~      Moreover, the suitability of the study design shall be investigated by means of the internal~     pilot part, i.e. concerning applied procedures, selected pharmacodynamic parameters and~     blood sampling scheme.~   "
131508|NCT01333917|"~     Colorectal cancer is a major problem in the United States and other developed countries. A~     safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia.~     Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of~     years as a traditional remedy. Curcumin blocks a number of targets involved in tumor~     initiation, promotion, and progression, and is considered a promising chemopreventive agent.~     The investigators propose to enroll 40 patients after screening colonoscopy who will have~     rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators~     will use microarray analysis to identify genes that are modified by curcumin that could be~     used as biomarkers in future chemoprevention studies. The study will also evaluate~     tolerability and toxicity.~   "
131509|NCT01333904|"~     The purpose of this study is to establish single and multiple dose safety in healthy~     subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition,~     the study will evaluate preliminary proof of concept endpoints in COPD subjects such as~     biomarkers in sputum and mucociliary clearance.~   "
131510|NCT01333891|"~     Age-related macular degeneration (AMD) and glaucoma are among the leading causes of~     blindness in the western world. Elevated intraocular pressure (IOP) is a well known major~     risk factor for glaucoma. In addition, there is growing evidence that vascular factors,~     including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD~     and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of~     the present study.~      Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity~     information through transparent media in vivo. Moreover, the images show a high choroidal~     penetration and a resolution comparable to an histologic examination when infrared light~     sources are used. Because of its non-invasive character, OCT provides an ideal method for~     diagnosis and monitoring of retinal and choroidal abnormalities.~      The present study aims to investigate whether choroidal thickness is temporarily altered by~     changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a~     suction cup technique, mean arterial blood pressure will be altered by intravenously~     administered Phenylephrine or Sodium-Nitroprusside.~   "
131511|NCT01333878|"~     The hypothesis of this study is that subcutaneous Abatacept is effective in reducing~     synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low~     field extremity MRI and X-ray.~   "
131512|NCT01333865|"~     The main objective of this study is to evaluate the safety and effectiveness of memantine~     (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism~     spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine~     whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The~     study results will be used to generate hypotheses for a larger randomized controlled~     clinical trial with explicit hypotheses and sufficient statistical power.~   "
131513|NCT01333852|"~     Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized~     phase II trial~   "
131514|NCT01333839|"~     In this study, the investigators want to examine the impact of coronary artery bypass graft~     (CABG) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90~     subjects. In extent, the impact of a subsequent exercise intervention will be examined, with~     a follow-up up to 12 months after surgery.~   "
131515|NCT01333826|"~     This study is designed to evaluate a two-year randomized intervention in Malawi that~     provides cash transfers to current schoolgirls (and young women who have recently dropped~     out of school) to stay in (and return to) school in order to understand the possible effects~     of such programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.~   "
131516|NCT01333813|"~     This study will evaluate the persistence of immunity to hepatitis B in healthy children aged~     7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life,~     and also their ability to mount an immune response to the challenge dose of Engerix-B™~     Kinder.~   "
131517|NCT01333800|"~     The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and~     Beclomethasone in pediatric asthma control.~   "
131518|NCT01333787|"~     The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the~     treatment of chronic constipation and on the colonic transit time in children.~   "
131525|NCT01333696|"~     The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as~     salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head~     and neck.~   "
131528|NCT01333657|"~     Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin~     superfamily of receptors that is specifically expressed on the surfaces of monocytes and~     neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the~     release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma~     sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that~     the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies~     indicate that there are increased levels of sTREM-1 in body fluid samples for the following~     diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis,~     peritonitis, and uterine cavity infection.~      Inflammation is now believed to play a major role in the pathophysiology of AKI. It is~     hypothesized that the initial insult results in morphological and/or functional changes in~     vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes~     including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into~     the injured kidneys and induce the generation of inflammatory mediators. Whether urine~     sTREM-1 could also be detected and its significance in sepsis and AKI has not been reported~     yet.~      The present study focused on the value of serum & urine sTREM-1 for sepsis identification,~     severity and prognosis assessments, and potential sepsis-related AKI. We also made~     comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and~     BUN among sepsis patients.~   "
131529|NCT01333644|"~     It is the central hypothesis of the investigators study that HIV disease is a~     pro-inflammatory condition, and that years of inflammation result in premature aging' of~     the immune system (immunosenescence). Just as these changes are thought be causally~     associated with heart disease in the very old,the investigators postulate that these changes~     will be associated with early heart disease in the untreated and perhaps treated HIV~     disease. To address this hypothesis, the investigators will measure immunosenescence in a~     large cohort of patients who span the entire disease process.~   "
131530|NCT01333631|"~     This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA)~     with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with~     unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for~     three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered~     using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT)~     with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses~     of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg.~     Treatment with VA will be commenced at the first day and will be terminated at last day of~     RT.The patients will be followed till disease progression or death.~   "
131531|NCT01333618|"~     It has been demonstrated that implantation of inferior vena cava filter was safe and~     effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous~     clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis,~     transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip~     Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%),~     severe tilting of the Günther Tulip Filter may be associated with difficulty or sometimes~     impossibility of retrieval. It has been reported that a simple technique of keeping tension~     of the delivery system may prevent significant tilting of the transjugular Günther Tulip~     Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip~     Filter from tilting has been reported. The investigators conducted a randomized, controlled~     study to test whether the introducer curving technique is useful to decrease the extent of~     tilting of transfemoral Günther Tulip Filter.~   "
131532|NCT01333605|"~     The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation~     as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.~   "
131533|NCT01333592|"~     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as~     combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show~     inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.~   "
131534|NCT01333579|"~     Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected~     hemisphere (UH) transiently improves motor function in patients in the chronic phase after~     stroke. The goal of this study is to investigate effects on motor recovery of low-frequency~     rTMS of the UH, administered in the subacute phase after stroke.~   "
131535|NCT01333566|"~     The long-term goal of our research program is to develop an effective and cost-saving~     mind-body therapy to help patients with FM. The objective of this pilot study is to gather~     pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients~     using a specific type of qigong exercise, i.e. six healing sound qigong. Changes in~     relevant brain activity will be monitored in study subjects before and after the qigong~     exercise program, which may help us in better understanding the underlying mechanism of the~     qigong exercise. Data collected in this pilot study will help the investigators in~     preparation for a future clinical trial with a larger sample size. Our central hypothesis~     for the future clinical trial is that qigong exercise will lead to a significantly greater~     improvement in pain, fatigue, sleep quality, and quality of life in the experimental group~     compared to the control group.~   "
131536|NCT01333553|"~     The researcher develop non-invasive imaging modalities for assessment of port wine stain~     during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to~     guide immediate retreatment of regions of persistent perfusion during the procedure.~   "
131537|NCT01333540|"~     A dose-escalation study to assess the safety, tolerability and clinical activity of TD−1211~     in patients with opioid-induced constipation.~   "
131558|NCT01333267|"~     This is a dose escalation study to determine the maximum tolerable dose of Parathyroid~     Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over~     one week in healthy African-American volunteers. The investigators plan to infuse low doses~     of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive~     suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an~     increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the~     investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism,~     markers of bone turnover, and fractional excretion of calcium. These results will be~     compared to previous studies of Caucasian volunteers.~   "
131538|NCT01333527|"~     Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is~     done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease~     pain, and to increase range of motion (ROM) and strength. This is done arthroscopically;~     through a small incision in the patient's shoulder. After surgery, patients are usually~     placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this~     time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or~     active shoulder movement is usually not permitted to allow the repaired tendons to heal.~     Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can~     delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function,~     a slower return-to-work or daily activities, and may also impact the health care system,~     through increased use and cost of rehabilitation.~      This study's purpose is to determine if patients can safely stop wearing their sling as~     early as pain and comfort allow following RC surgery. A total of 200 patients (100 per~     group) will be randomly assigned to one of two study groups:~      Patients in Group A (accelerated rehab) will wear their sling for comfort only following~     surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may~     stop wearing their sling if pain and comfort allow, and start active movement for activities~     of daily living only.~      Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A,~     self-assisted ROM exercises are allowed at any time, but active movement will not be allowed~     until 6 weeks after surgery. Patients in both groups will be given the same self-assisted~     ROM exercises after surgery.~      Patients who agree to participate in the study will see their surgeon and the study physical~     therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12~     months post-surgery). Each visit will take about 30 minutes and will include a ROM~     assessment, strength assessment (as appropriate) and disease-specific quality of life~     questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair~     is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity,~     and adverse events will be examined between the two groups. Differences will also be~     examined according to RC tear size and patient characteristics.~   "
131539|NCT01333514|"~     Good sugar control in postoperative hospitalized patient has been shown to improve wound~     healing and infection rates. However, sugar control is difficult to achieve and suboptimal~     use of insulin is thought to be a contributory factor. Though it is known that generally the~     consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing~     meal-time insulin is based on the fraction of the total meal-tray eaten which includes~     proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a~     patient who consumes a portion of mainly proteins and fats on their trays or an~     underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high~     blood sugars can follow respectively.~      Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams~     of carbohydrates consumed will result in better sugar control compared to the usual practice~     of dosing meal-time insulin based on percent of total meal consumed in hospitalized~     patients.~   "
131540|NCT01333501|"~     The purpose of this pilot study is to evaluate, by means of a specific cognitive test~     battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the~     slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of~     treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate~     which test of the battery is the most sensitive in detecting differences between treatment~     groups.~   "
131541|NCT01333488|"~     The investigators hypothesize that hypothermia (body cooling) and additional magnesium~     sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.~      This is a study to compare the outcomes of patients with severe traumatic brain injury who~     have been allocated to one of the following three groups:~      Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have~     their core body temperature lowered to 34C Group 3 - Subjects will have their core body~     temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium~     sulfate.~   "
131542|NCT01333475|"~     Background:~      - MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the~     effect of certain proteins that cancer cells need to grow and survive. These drugs may be~     effective treatments for some types of colorectal cancer that has not responded to or has~     relapsed after standard treatment. Researchers are interested in studying how MK-2206 and~     AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs~     work against cancer cells by examining cells from a tumor sample collected before the drugs~     are given and again after the drugs are given.~      Objectives:~      - To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with~     advanced colorectal carcinoma that has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with advanced colorectal~     carcinoma that has not responded to at least one type of standard chemotherapy.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and tumor imaging studies.~        -  Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment,~          with one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants~          have negative side effects from the medications, the doses will be adjusted to a~          smaller dose). Participants will keep a diary to record doses and keep track of any~          side effects.~        -  During treatment, participants will have regular visits to the clinical center,~          involving blood and urine tests, tumor biopsies, and other examinations to monitor the~          effects of treatment. Participants will have imaging studies every two cycles (8 weeks)~          to study the cancer's response to the treatment.~        -  Participants will continue to have cycles of treatment for as long as the treatment~          continues to be effective and the side effects are not severe enough to stop~          participation in the study....~   "
131543|NCT01333462|"~     The purpose of this study is to test the safety and immune response of a new intranasal~     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine~     that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps~     a vaccine work better), called W805EC.~   "
131544|NCT01333449|"~     Allogeneic blood stem cell transplant remains the only potential curative treatment for~     myelodysplastic syndromes (MDS) to date. Pre-transplant induction chemotherapy with~     leukemia-type regimens is associated with significant toxicity and even death. The~     hypomethylating agents decitabine and 5-azacytidine have been shown in studies to cause~     improved hematologic parameters and partial or complete responses in patients with high risk~     MDS compared to standard therapy. In contrast to leukemia-type chemotherapy, decitabine is~     associated with a relatively low risk of toxicity. We therefore propose to treat~     transplant-eligible MDS patients with Decitabine as induction therapy and a bridge to~     transplant.~      Hypothesis:~        1. Decitabine is able to reduce disease burden as measured by blood and marrow blast~          counts prior to allogeneic hematopoietic stem cell transplant to below 5%.~        2. Decitabine is well-tolerated by patients with high-risk MDS and will be a safe~          induction agent and bridge prior to allogeneic transplant in transplant-eligible~          patients.~   "
131545|NCT01333436|"~     This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in~     diabetic participants compared to nondiabetic participants with the same range of serum~     LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify~     potential cardiovascular disease risk.~   "
131546|NCT01333423|"~     The goal of this clinical research study is to find the highest tolerable dose of seliciclib~     that can be given in combination with liposomal doxorubicin to patients with metastatic~     breast cancer.~   "
131574|NCT01333059|"~     The purpose of this study is to determine if the reduction of the total amount of sedative~     critically pediatric ill patients receive in the PICU will achieve a significant decrease in~     mechanical ventilation days and a decrease in the overall length of stay in the PICU and~     hospital.~   "
131547|NCT01333410|"~     Vitiligo has remained a difficult disease to treat. Previous available therapies are often~     ineffective. It usually takes several months or years for complete repigmentation and some~     areas of the body get at best only partial repigmentation. The desire of the patient to~     undergo therapy varies from patient to patient and needs to be assessed individually.~     Several factors should be considered when planning the treatment strategies including type~     of vitiligo, site and degree of involvement, skin color, psychological effect, patient~     compliance, ease to assess to therapy, cost of treatment and social association of the~     disease.~      Topical corticosteroids are still be the standard treatment of localized vitiligo. However,~     the adverse effects such as skin atrophy, striae, pigmentary change and~     hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength~     of topical steroids for a long period of time.~      Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell~     activation and cytokine release. It offers a safe and efficacious alternative for many skin~     conditions. It minimizes the need for topical glucocorticoids and does not cause skin~     atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying~     mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of~     melanocytes and melanoblasts.~      This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus~     ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.~   "
131548|NCT01333397|"~     The primary objective is to assess the dose response versus placebo of a single treatment of~     Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of~     moderate to severe glabellar lines at maximum frown.~   "
131549|NCT01333384|"~     The purpose of this study is to evaluate over the 24 month prospective follow up - in~     everyday clinical practice - resource utilization and effectiveness of the treatment of~     acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection~     intervals.~   "
131550|NCT01333371|"~     Patients will be randomized to volar plating with early ROM versus closed reduction with~     K-wires and 6 weeks of cast immobilization to determine if there is any advantage to volar~     plating in this subgroup of patients with distal radius fractures.~   "
131551|NCT01333358|"~     The main purpose of this research study is to investigate how well a medicine (alemtuzumab)~     works in treating MS-related cognitive problems (e.g., attention, memory, speed of~     thinking). This study will include 30 subjects from six research sites.~      Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some~     types of leukemia. As a leukemia treatment, it is given more often and at much higher doses~     than in this study.~   "
131552|NCT01333345|"~     The purpose of this study is to obtain data on the performance of the EC-3 lens at an~     interval of two years (and beyond) from subjects who were implanted. The primary aim of the~     study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies~     in the subjects.~   "
131553|NCT01333332|"~     The purpose of this study is to determine safety and to obtain preliminary estimates of the~     rate of major pathologic response of neoadjuvant accelerated fraction, standard dose~     radiation given with chemotherapy in patients with locally advanced pancreas cancer.~   "
131554|NCT01333319|"~     Renal dysfunction is a major risk factor for poorer outcome after liver transplantation.~     Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly~     understood. Calcineurin inhibitors are generally perceived as the most important cause;~     however the liver transplant procedure itself represents a major surgical / hemodynamic /~     inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and~     creatinine clearance are late markers of acute kidney injury and changes in these parameters~     occur only after substantial injury has already occurred. Even a stable creatinine does not~     exclude structural kidney damage.~      A series of new markers of tissue injury have been identified and have the potential to~     identify acute kidney injury better and earlier than creatinine and creatinine clearance.~     The aim of this study is to determine whether and how liver transplantation affects these~     urinary and plasma biomarkers and to study whether the changes in these biomarkers may~     predict later changes in standard functional parameters (creatinine and creatinine~     clearance). For this purpose, the urinary and plasma biomarkers, together with creatinine,~     will be determined serially during the different phases of the liver transplant process and~     daily until day 5 after transplantation.~   "
131555|NCT01333306|"~     Cognitive rehabilitation involves enhancing an individual's capacity to process information~     to improve their everyday functioning. One common form of intervention is computerised~     cognitive training (CT); however, efficacy results have been mixed. This research aims to~     investigate a novel method for enhancing outcomes from CT through combining CT with~     transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain~     stimulation. In this study we aim to determine the efficacy of this approach through~     comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in~     healthy participants. We hypothesise that tDCS combined with CT will have greater~     generalisability effects than the other conditions.~   "
131556|NCT01333293|"~     Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,~     fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by~     mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid~     reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast~     media, local anesthetics or analgesics. In addition, there is increased osteoporosis in~     mastocytosis patients due to the activity of mast cell mediators on osteoblasts and~     osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or~     other antiallergic drugs. There is currently no specific treatment for this disease with the~     exception of rare cases. There are, however, some case reports suggesting that omalizumab~     might decrease symptoms including hypotensive events.~      The aim of the study is to investigate whether patients suffering from mastocytosis benefit~     from a 6 month course of omalizumab with regard to symptoms and quality of life and whether~     the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the~     efficacy of omalizumab in patients with mastocytosis.~        -  Trial with medicinal product~   "
131557|NCT01333280|"~     The purpose of the study is to determine whether adding dual focus mutual aid groups to~     formal treatment for people dually diagnosed with substance abuse and mental illness is~     effective in improving treatment outcomes.~      NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT~     PROGRAMS.~   "
131559|NCT01333254|"~     The aim of the project is to evaluate differences between intermittent and indwelling~     catheterisation in patients with hip surgery.~      Specific objectives are to determine whether:~        -  frequencies of urinary tract problems in hospital and up to one year after discharge~          differ between patient groups treated with intermittent and indwelling catheterisation~          respectively.~        -  costs and health-effects differ between the patient groups.~        -  experiences of urinary catheterisation differ between the patient groups~   "
131560|NCT01333241|"~     The overall goal of this randomized controlled trial is to evaluate the effects of a~     community-based lifestyle behavior intervention (LSBI) that is designed to improve diet,~     reduce weight and increase physical activity (PA) of Latino women who are predominantly~     Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas~     participating in a LSBI conducted by promotoras will demonstrate a greater decrease in BMI~     and a higher increase in physical activity than those in a control condition, Women in the~     LSBI also are expected to demonstrate improvements in selected physiologic outcomes (blood~     pressure [BP], measures of cholesterol and blood sugar, waist circumference), and~     self-reported lifestyle behaviors (diet, PA). of these participants are also e~   "
131561|NCT01333228|"~     Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and~     peripheral blood cells. EPCs are recruited into injured tissues and play an important role~     in regeneration and reparation. Experimental and clinical data suggest that EPCs have~     hepatoprotective activity and could improve liver regeneration during acute and chronic~     liver injury. The aim of this project is to evaluate the safety and therapeutic effects of~     autologous bone marrow-derived EPCs, when administered through the hepatic artery of~     patients with advanced liver cirrhosis.~   "
131562|NCT01333215|"~     The purpose of this study is to compare the cognitive inhibition deficit among depressed~     older suicide attempters compared to depressed older suicide non-attempters.~   "
131563|NCT01333202|"~     The purpose of this study is to determine whether fresh lime alone is effective for smoking~     cessation.~   "
131564|NCT01333189|"~     The purpose of this study is to determine if rehabilitation using weight-bearing biofeedback~     training following total knee arthroplasty (TKA) is more effective than standard~     rehabilitation methods in promoting weight-bearing symmetry through the lower limbs during~     functional activities such as sit-to-stand transfers and walking. Secondary outcomes of~     interest include functional measures and internal moment at the hip, knee, and ankle joints~     during sit-to-stand and walking.~   "
131565|NCT01333176|"~     1. Purpose~             -  to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a~               BC First Nation community~             -  to determine the utility of community based screening by examining how many~               positively screened people follow up with the recommended subsequent testing and~               family physician visit~             -  to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the~               confirmatory fasting and 2 hour post challenge blood glucose tests.~        2. Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic~          tests and prove to be a useful tool for community-based screening. This test obviates~          the need for fasting and repeat glucose tolerance testing.~   "
131566|NCT01333163|"~     The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects~     kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect~     on kidney hemodynamics.~   "
131567|NCT01333150|"~     The project's primary purpose is to test the hypothesis that oral administration of a low~     single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with~     masticatory muscle pain.~   "
131568|NCT01333137|"~     P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T~     inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer~     cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of~     gemcitabine and carboplatin when administered with or without P276-00 in subjects with~     advanced triple negative breast cancer.~   "
131569|NCT01333124|"~     This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with~     gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.~   "
131570|NCT01333111|"~     This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this~     trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which~     the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used~     for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.~   "
131571|NCT01333098|"~     This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive~     impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and~     disabling in older adults. One particularly impairing aspect of late-life anxiety disorders~     is cognitive impairment: impairments in memory and executive function cause disability,~     impede treatment response to psychotherapy, may lead to dementia, and are not corrected by~     standard anti-anxiety treatments.~      This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive~     impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated~     cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily~     in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder,~     with well-documented safety and tolerability.~   "
131572|NCT01333085|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving~     everolimus together with carboplatin and paclitaxel in treating patients with locally~     advanced head and neck cancer that cannot be removed by surgery.~   "
131573|NCT01333072|"~     The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will~     provide evidence-based guidance in the selection and monitoring of drug treatment of autism.~     BAART involves 3 academic centers across South Carolina. Although the FDA has approved use~     of the antipsychotic drug risperidone for irritability associated with autistic disorder, a~     moderate response rate in pivotal clinical trials and concerns over tolerability and weight~     gain can force clinicians to select alternative drug treatments for which evidence-based~     support is sparse.~   "
131575|NCT01333046|"~     Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has~     come back, or may come back, or has not gone away after treatment, including the standard~     treatment known for these diseases. This a research study using special immune system cells~     called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental~     therapy.~      This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that~     show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease). EBV is found in cancer cells of up to half~     of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a~     role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's~     immune system and escape being killed. Investigators tested whether special white blood~     cells, called T cells, that were trained to kill EBV-infected cells could affect these~     tumors, and in many patients it was found that giving these trained T cells caused a~     complete or partial response.~      However, many patients do not have EBV in their lymphoma cells; therefore investigators now~     want to test whether it is possible to direct these special T cells against other types of~     proteins on the tumor cell surface with similar promising results. The proteins that will be~     targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins~     that are specific to the cancer cell, so they either do not show or show up in low~     quantities on normal human cells.~      In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1,~     MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called~     cytotoxic T lymphocytes (CTLs) generated in the lab.~      In addition, some adult patients will receive a drug called 5-azacytidine before giving the~     T cells. We hope that the combination helps the T cells work better.~   "
131576|NCT01333033|"~     RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response~     to treatment and help plan the best treatment.~      PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response~     in patients with esophageal cancer receiving combination chemotherapy.~   "
131577|NCT01333020|"~     This comparative pilot study is designed to compare the rates of gastric emptying and by~     inference rates of digestion of two food emulsions. Two types of milk protein stabilised~     food emulsion will be compared, one standard emulsion preparation and one emulsion~     preparation cross-linked with microbial transglutaminase. The information from this study~     will then be compared to data on satiety and endocrine hormones from a parallel study~     undertaken in Finland using the same two meal formulations. The drinks will be labeled with~     a stable isotope of carbon and samples of breath collected every 20 minutes after~     consumption of the drink. This will allow gastric residence time to be calculated. The pilot~     will also fulfill two secondary objectives. At the same time as the breath samples are~     collected MRI scans of the upper abdomen will be made so that gastric volumes can be~     measured in order to compare the two methods of measuring gastric emptying rates.~     Additionally, samples of saliva will also be collected after every MRI scan for subsequent~     mass spectrometry analysis. These are to assess the efficacy of mass spectrometry analysis~     for detection of the presence of specific digestion related hormones such as ghrelin.~   "
131578|NCT01333007|"~     This observational study will evaluate modality, efficacy and safety of Avastin~     (bevacizumab) as first-line treatment in combination with chemotherapy in patients with~     inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in~     clinical practice. Data will be collected for each patient for 18 months from initiation of~     Avastin therapy.~   "
131579|NCT01332994|"~     This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate~     the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid~     arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for~     12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an~     inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g~     MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study~     treatment is 32 weeks.~   "
131580|NCT01332981|"~     This is an observational follow-up study on the efficacy of 1st-line treatment with~     Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation~     of treatment.~   "
131581|NCT01332968|"~     This open-label, randomized study will assess the efficacy and safety of obinutuzumab~     (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with~     chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with~     untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period,~     patients achieving response (CR or PR) will go on to a maintenance period thereby continuing~     on their randomized antibody treatment alone every 2 months until disease progression for a~     total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years.~     After maintenance or observation patients will be followed for 5 years until progression.~     After progression, patients will be followed for new anti-lymphoma therapy and overall~     survival until the end of the study.~   "
131582|NCT01332955|"~     This phase II, multicentric, national pilot trial is designed to estimate the sustained~     virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a~     48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological~     response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR~     to 20%, a rate determining a significant therapeutic benefit in this population of patients.~     The primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after~     the end of therapy (EOT).~   "
131583|NCT01332942|"~     The drug that is under investigation during this study is BAY85-3934 which is intended to be~     used as a treatment for patients suffering from renal anemia due to chronic kidney disease~     (stage 3 and 4).~      The purpose of this study is to provide safety and tolerability information on the drug.~     Other objectives of the study are to investigate the effect of the drug on the body~     (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and~     excretion (pharmacokinetics) by measuring the concentration in blood and urine.~      The study will be conducted in one study center in the United Kingdom and several centers in~     Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will~     participate in the study. BAY 85-3934 will be given following a combined single / multiple~     dose escalation design in seven (of which three are optional) dose steps.~   "
131600|NCT01332721|"~     The purpose of the study is to evaluate safety and tolerability and determine a recommended~     Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced~     solid tumors for which bevacizumab is indicated.~   "
131601|NCT01332708|"~     The investigators aims in the current study are to examine whether the cholinergic status~     should be considered as another risk factor for the metabolic syndrome and it's~     co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on~     the cholinergic status of overweight and obese adults with and without the metabolic~     syndrome.~   "
131584|NCT01332929|"~     This phase I pilot study aims to define the safety of a combined treatment of bevacizumab~     and whole brain radiation therapy for the treatment of patients with brain metastasis of~     solid tumors. If this therapeutic scheme confirms it's safety profile, the investigators can~     expect:~        -  first, to allow that all patients can receive bevacizumab for their advanced and/or~          metastatic cancer if necessary, even in case of brain metastasis.~        -  Secondly, if this trial confirm a synergic effect of the combination of angiogenesis~          inhibitors and brain radiotherapy for local control of brain metastasis, an improvement~          of the therapeutic results for these patients which have a poor hope of survival and~          for which none innovative approach is currently suggested.~      Moreover, the investigators hope that the analysis of the different data of MRI evaluation -~     morphological and functional - will allow better definition of radiological evaluation of~     the therapeutic effect of angiogenesis inhibitors on brain metastasis.~   "
131585|NCT01332916|"~     The purpose of this study is to investigate memory problems in patients with cancer.~   "
131586|NCT01332903|"~     This is a phase I, open label, healthy volunteers, ADME study with single oral~     administration of [14C] AZD5069.~   "
131587|NCT01332890|"~     To evaluate drug-drug interaction~   "
131588|NCT01332877|"~     EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND~     CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy~      Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes~     weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either~     in calories or Carb produce withdrawal effect, that further exacerbate Carb craving~     resulting in rapid return of obesity. Meal timing and composition has shown to play a~     pivotal role in appetite regulation through several hormonal systems such as ghrelin. The~     investigators hypothesized that to be successful; a weight loss strategy must change the~     hormonal environment to increase satiety while reducing hunger and craving.~      Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two~     isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.~      Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary~     adults with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an~     isocaloric diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and~     1600 kcal for men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of~     13:40:48. HCPbd breakfast will provide 600 kcal with 50:20:30. From baseline until week 16~     participants will take part in a supervised weight loss diet, followed until week 32 by a~     maintenance period. Anthropometric measures, OGTT for glucose and insulin, VAS-measured~     hunger and satiety and Food Craving Inventory Analysis will be performed at baseline, week~     16 and week 32.~   "
131589|NCT01332864|"~     Participants with chronic or recurrent headache, unrelated to any known pathology or~     disease, will be randomly assigned to one of four interventions: Osteopathic manipulation of~     the body other than the head, osteopathic manipulation of the head, osteopathic manipulation~     of the head and rest of the body, or light touch on the head only but no manipulation.~     Measurements of heart rate and blood pressure variability, peripheral blood flow, and~     behavioral changes, such as mood, pain duration, intensity and frequency will be assessed.~   "
131590|NCT01332851|"~     The study evaluates the feasibility and effectiveness of a well-documented~     relationship-based intervention (Promoting First Relationships), compared to a resource and~     referral condition, in improving outcomes for families of infants and toddlers referred to~     Child Protective Services (CPS) for maltreatment. In addition, it evaluates the~     effectiveness of training community social service workers in providing the intervention.~   "
131591|NCT01332838|"~     The purpose of this study is to determine if the use of specialized compression garments, in~     comparison to standard compression, improves early patient outcomes after endovenous~     ablation.~   "
131592|NCT01332825|"~     The purpose of this study is to determine the normal distribution of nasal tissue~     cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects~     with smell dysfunction. The investigators will also look at the effect of nasal saline~     irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting~     olfactory cilia. The investigators hypothesize that nasal saline will have no effect on~     olfaction and will be inadequate to harvest olfactory cilia.~   "
131593|NCT01332812|"~     This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive~     dysfunction in the postoperative period of elderly patients undergoing to surgery under~     general anesthesia.~   "
131594|NCT01332799|"~     Cardiovascular disease is the leading cause of mortality in kidney transplantation. The~     enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney~     transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health~     and protects against cardiovascular complications.~   "
131595|NCT01332786|"~     The purpose of this study is to determine whether tigecycline is safe and which dosage is~     most effective in the treatment of patients with acute myeloid leukemia.~   "
131596|NCT01332773|"~     To show whether the artery first approach leads to equal or less rate of positive resection~     margins in pancreatic head cancer than the standard technique (ppWhipple only with standard~     Kocher's manoeuvre)~   "
131597|NCT01332760|"~     Dentists and dental hygienists experience elevated rates of musculoskeletal disorders, such~     as carpal tunnel syndrome and tendonitis, primarily due to the high pinch force required for~     dental scaling. There is evidence that a lighter and larger diameter tool can significantly~     reduce the pinch force. This randomized controlled study will determine if dentists or~     dental hygienists who use such a tool report less hand and arm pain compared to those who~     continue to use the conventional tool design.~   "
131598|NCT01332747|"~     The purpose of this clinical trial is to study the comparative effect of a classical unani~     antiobesity drug safoof-e-muhazzil on hyperlipidemia in its classical powder form and in~     compressed tablet form against a standard control.~   "
131599|NCT01332734|"~     During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed.~     Restoration of bloodpressure and cardiac performance may not be sufficient to correct these~     alterations. Magnesium is a potent vasodilator which may be used to open up the small~     vessels, in order to reduce organ failure.~   "
131604|NCT01332669|"~     In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is~     the standard treatment and reported as a significantly better treatment through randomized~     comparison study like Llovet, etc. than conservative treatment. Recently, doctors do~     transarterial chemoembolization with drug-eluting bead, and it is proved less side effect~     and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr.~     Lammer, etc. But, it could not defined improved survival rate as expected. This study's~     purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug~     eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for~     unresectable hepatocellular carcinoma.~   "
131605|NCT01332656|"~     Primary Objective:~      - To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus~     placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with~     paclitaxel and carboplatin.~      Secondary Objectives:~        -  To compare the overall survival (OS) between the 2 treatment arms~        -  To compare the objective response rate (RR) between the 2 treatment arms~   "
131606|NCT01332643|"~     This study evaluates the effect of single embryo transfer (SET) with and without array CGH~     for the evaluation of the complete chromosome complement of the blastocyst. Patients will be~     allocated at random into two groups. The control group will consist of patients in which one~     embryo will be replaced on day 5 based on morphological and developmental characteristics,~     and the other embryos reaching blastocyst stage will be vitrified. The test group will~     consist of patients undergoing embryo biopsy at the blastocyst stage (day 5 of development,~     embryo freezing, and analysis of the biopsied cells with a comprehensive chromosome analysis~     technique (array Comparative Genome hybridization or aCGH). Only a chromosomally normal~     blastocyst will be replaced in a thawed cycle. Inclusion and exclusion criteria are~     described in the study population section.~   "
131607|NCT01332630|"~     The goal of the first part of this clinical research study is to find the highest tolerable~     dose of TPI-287 in patients with breast cancer that has spread to the brain.~      The goal of the second part of this study is to learn if TPI-287 can control breast cancer~     that has spread to the brain. The safety of this drug will also be studied.~   "
131608|NCT01332617|"~     The purpose of this study test the hypothesis that the combination of simvastatin and~     zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose~     methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an~     effective and well-tolerated treatment for relapsed and refractory multiple myeloma~   "
131609|NCT01332604|"~     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with~     capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients~     with advanced or metastatic solid tumors.~   "
131610|NCT01332591|"~     The aim of the study is to find the optimal management of patients with acute myocardial~     infarction with ST elevations treated by primary PCI who have at least one significant~     stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence~     of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke~     during the follow up of 24 months in group of patients treated with staged revascularization~     (PCI or CABG) in comparison with patients treated conservatively.~   "
131611|NCT01332578|"~     The study is designed to investigate whether paracetamol from a hot remedy reaches the~     plasma faster than standard paracetamol tablets. The study will also assess the~     gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma~     scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot~     remedies, provides a greater early exposure compared to standard paracetamol tablets. In~     addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be~     investigated.~   "
131612|NCT01332565|"~     This study is a Phase 1, open label, non-randomized, single dose study to determine~     pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral~     administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be~     enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening~     visit within 30 days prior to the administration of study drug, a treatment visit, and a~     follow-up visit 7-14 days after the administration of study drug.~   "
131613|NCT01332552|"~     GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed~     for the treatment of chronic HCV infection. HBI115040 is the first administration of~     GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and~     antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV~     infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of~     GSK2485852.~      HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation~     fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile~     of GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir~     co-administration (Part 3) in chronically infected HCV subjects. The study will also explore~     the effect of a moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part~     1.~   "
131614|NCT01332539|"~     observational, non-interventional study in 120 patients with drug-resistant partial~     epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As~     control group, 120 patients with controlled partial epilepsy will be enrolled. The objective~     of the study is to describe the burden of illness in this epileptic population both in terms~     of costs and of quality of life. Costs and quality of life will be also compared between the~     two populations.~   "
131623|NCT01332422|"~     To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS~     and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long~     term under the practical use conditions. In this special drug use investigation, the~     following items shall be handled as the priority investigation items for information~     collection.~        1. Systemic effects accompanying steroid administration; influences on adrenocortical~          function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract,~          glaucoma~        2. Events related to nervous system, musculoskeletal system and circulatory system;~          tremor, headache, cramp, tachycardia, etc.~   "
133089|NCT01313299|"~     The purpose of this research study is to assess the efficacy of Dysport compared to placebo~     in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or~     traumatic brain injury.~   "
131615|NCT01332526|"~     Fructose intake from added sugars has increased dramatically over the last century and has~     recently been implicated as potential contributor to metabolic syndrome, obesity,~     hypertension, inflammation and kidney disease. Fructose differs from the other sugars~     because, uric acid is generated during its metabolism. Serum uric acid levels have been~     found to correlate with the intake of fructose and added sugars. In turn, an elevated serum~     uric acid has also been shown to be associated with increased risk for cardiovascular and~     metabolic diseases. On the other hand complexity of fructose metabolism in each individuals~     results of the various magnitude of hyperuricemia induced by fructose intake. The magnitude~     of uric acid production in each patient may reflect individual predisposition to endogenous~     urate production in a face of relatively normal fasting uric acid concentration. Therefore~     the oral fructose tolerance test might reveal an occult purine disturbances which plays~     casual role in either metabolic disturbances or organ damage.~      The aim of this study is to see whether is a relationship between fructose induced~     hyperuricemia and metabolic disturbances , inflammatory state and organ damage in obese and~     various stages CKD patients.~   "
131616|NCT01332513|"~     This is an open-label, single centre, repeat dose, up- titration study in healthy male and~     female subjects to assess the pharmacokinetic (PK) performance of five prototypes of~     ezogabine modified release tablet formulations.~      The study will consist of a screening period, a treatment phase (consisting of a titration~     phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit.~     The study duration from screening to follow up will be approximately 7 weeks. No study~     procedures will start before informed consent is obtained. Subjects will remain in the~     clinical unit for the duration of the treatment period (35 days).~      Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100~     mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days~     1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end~     of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD.~      On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR~     formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID).~     Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic~     analysis will be collected up to 24 hours post dose on each 4th day (PK days).~      On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations~     being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33~     (following a standard breakfast), and on Day 34 (following a high fat breakfast) to~     investigate a food effect on the PK profile of ezogabine.~   "
131617|NCT01332500|"~     The purpose of this retrospective claims database study was to compare the change in~     migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine~     suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects~     initiating treatment with other orally available triptans. The study was used to validate~     the migraine-related prescription utilization patterns predicted by the Treximet ™ Budget~     Impact Model.~      The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis.~     The database contains 30% of prescription claims filled in the United States (US),~     approximately 160 million patient lives. The data has broad representative coverage at both~     the geographic and payment levels.~   "
131618|NCT01332487|"~     This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase~     inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of~     acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as~     prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized~     for this study (2000-2008).~   "
131619|NCT01332474|"~     To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or~     older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity,~     compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to~     the possible spread of toxin are reported through the spontaneous ADR reporting system, and~     discuss potential risk factors for such ADRs.~   "
131620|NCT01332461|"~     This was a retrospective cross-sectional database study using administrative data (study~     period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least~     one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and~     496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index~     event) during the study period was the target population. All subjects were required to have~     one year of pre-index period baseline data. COPD events of interest were ER, Hospital and~     physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days.~     Other censoring events were treatment switch; loss of enrollment; >60-day gap between~     medication fills; or end of study period.~      This study is a non descriptive hypothesis testing study. Key study hypotheses are listed~     below.~      Specifically the study hypotheses for the primary outcome being tested were:~      Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha:~     There is a difference in risk of COPD-related hospitalization between FSC and OMT~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a~     difference in COPD-related costs between FSC and OMT~   "
131621|NCT01332448|"~     Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat~     to establish whether there is any indication of liver toxicity. The motivation is a~     cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following~     spontaneous reports of liver toxicity in people taking Xenical or Alli.~   "
131622|NCT01332435|"~     This retrospective study aims to assess the economic impact of early initiation of~     5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving~     5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information~     Solutions and PharMetrics databases will be utilized for this study (2000-2007).~   "
131624|NCT01332409|"~     To investigate possible problems or questions in safety and effectiveness of salmeterol and~     fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic /~     emphysema). In this special drug use investigation, onset of pneumonia shall be handled as~     the priority investigation item.~   "
131625|NCT01332396|"~     Data on the safety and efficacy of TYKERB shall be collected from the patients in order to~     grasp the actual conditions of post-marketing use and assess background information on the~     patients.~   "
131628|NCT01332357|"~     The objective of this study is to compare readmission to the emergency department for asthma~     in asthma patients who receive treatment with fluticasone propionate and salmeterol oral~     inhaler after an initial emergency department visit using a retrospective observational~     cohort study design.~   "
131629|NCT01332344|"~     The objective of this study is to compare healthcare utilization and costs in asthma~     patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg (FSC~     100/50) or inhaled corticosteriods in typical clinical practice using a retrospective~     observational cohort study design of large managed care database.~   "
131630|NCT01332331|"~     A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and~     efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in~     subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An~     additional objective is to determine the ambrisentan population pharmacokinetics in the~     paediatric population. The study will include a screening/baseline period and a treatment~     period. The treatment period will be 24 weeks or until the subject's clinical condition~     deteriorates to the point that alternative/additional treatment is necessary. Patients who~     participate in the study and in whom continued treatment with ambrisentan is desired will be~     eligible to enrol into a long term follow-up study. The primary comparison will be the~     safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric~     PAH population The secondary comparison will be the change from baseline for the efficacy~     parameters between the two treatment groups.~   "
131631|NCT01332318|"~     This study was a multi center, randomized, double blind, active and placebo controlled,~     parallel group study to assess simulated driving performance in XP13512 treated subjects~     with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily~     dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one~     of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the~     effects of an agent known to have sedative properties, while the other 3 groups received a~     DPH placebo.~   "
131632|NCT01332305|"~     The objective of the study was to generate the data necessary to determine the gabapentin~     exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or~     placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome~     (RLS).~   "
131633|NCT01332292|"~     This study will investigate the effect of dosing with flutucasone furoate in asthmatic~     subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over~     a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and~     serum cortisol levels.~   "
131634|NCT01332279|"~     This phase I trial studies the side effects and best dose of giving everolimus (RAD001) and~     erlotinib hydrochloride together with radiation therapy in treating patients with recurrent~     head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001~     and erlotinib hydrochloride together with radiation therapy may kill more tumor cells.~   "
131635|NCT01332266|"~     The purpose of this study is to determine whether patients with Platinum-Resistant Squamous~     Cell Carcinoma of the Head and Neck who receive either E7050 administered with Cetuximab or~     Cetuximab alone experience greater benefit~   "
131636|NCT01332253|"~     The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will~     significantly reduce post-operative fentanyl use compared to placebo.~   "
131637|NCT01332240|"~     As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely~     spread in Belgium, the investigators aimed to determine the number of mediastinoscopies~     needed to detect one additional mediastinal lymph node invasion during routine clinical~     practice in the staging of potentially resectable clinical stage III non-small cell lung~     cancer.~   "
131638|NCT01332227|"~     The purpose of this study is to determine whether HIV-1—infected patients, who are~     virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus~     any third agent but are experiencing safety and/or tolerability issues, will maintain~     virologic suppression after switching to a regimen of heat-stable ritonavir boosted~     atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.~   "
131639|NCT01332214|"~     This is a randomised, single-blind, placebo-controlled Phase I study to investigate the~     safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to~     healthy male subjects.~   "
131640|NCT01332201|"~     Comparison of tacrolimus blood levels in adults who have received a transplant and are~     taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This~     is followed by checking of safety and effectiveness for one year.~   "
131641|NCT01332188|"~     The purpose of this study is to evaluate the efficacy of different concentrations of AC-170~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis~     in the conjunctival allergen challenge (CAC) Model.~   "
131642|NCT01332175|"~     Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP)~     versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of~     obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.~   "
131643|NCT01332162|"~     The purpose of this study is to evaluate the benefit of the optimal pacing configuration,~     including the possibility of biventricular or left ventricular pacing, in hypertrophic~     obstructive cardiomyopathy patients.~   "
131644|NCT01332149|"~     Pregabalin has proven effective in previous clinical trails in other countries in relieving~     neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.~      This study is being conducted according to China registration requirement to submit a~     reapplication with new local diabetic peripheral neuropathy study as a commitment plus the~     existing data to apply for Lyrica pain associated with postherpetic neuralgia indication~     after Lyrica pain associated with postherpetic neuralgia is approved.~   "
131645|NCT01332136|"~     This research study will be completed by enrolling a prospective, observational cohort study~     to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This~     investigation will compare quality of life outcomes between each treatment type, as well as~     measure cellular and molecular markers of inflammation in the sinus mucosa, to create models~     that predict improvement in quality of life following treatment.~   "
131646|NCT01332123|"~     This study is investigating the influence of several simulated real life conditions on the~     symmetry of gait with trans-tibial prostheses~      Hypotheses: It is hypothesized that the observable differences in gait pattern between~     amputees can be detected by a combination of forces and moments that are measured internally~     in the prosthesis, and electromyography data. It is further hypothesized that changing~     conditions such as uneven walking surface, prosthetic misalignment or user fatigue are~     characterized by typical values in the measured data or combinations thereof.~   "
131647|NCT01332110|"~     Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be~     associated with higher than normal knee joint loading. Footwear has been developed that may~     decrease these knee loads in healthy subjects, but their effects on patients with PFPS are~     unknown. In this study, we aim to test the effects of such footwear on patients with PFPS.~     We hypothesize that patients who receive the footwear intervention will show a decrease in~     knee joint loading, and consequently will show improvements in subjective levels of~     perceived knee pain over a period of six weeks compared to a control condition.~   "
131648|NCT01332097|"~     This study will assess preliminary parameters of safety and efficacy of a single dose of~     BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.~   "
131649|NCT01332084|"~     The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in~     order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for~     children with allergy to wheat. The study has the potential to offer a desensitization~     treatment option for children allergic to wheat.~      The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side~     effects than native wheat cereals.~   "
131650|NCT01332071|"~     The study is prospective, open-label, randomized, crossover, with 02 treatments, 02~     sequences, and 02 periods. The volunteers received, in each period, the reference or the~     test formulation after standardized meals.~   "
131651|NCT01332058|"~     The investigators are conducting a pilot study for a clinical research trial to establish~     the feasibility and acceptability of the intervention and the most effective recruitment~     strategies prior to the full study.~   "
131652|NCT01332045|"~     Our study will compare the use of continuous saphenous nerve block performed at the adductor~     canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to~     LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block~     performed at the level of the adductor canal in addition to LIA provides better pain relief~     than the LIA alone without significantly compromising muscle strength and physiotherapy,~     enabling patients to mobilize early with reduced opioid consumption and les side effects.~      The investigators will enroll a total of 40 patients (20 patients will receive continuous~     saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until~     discharge, the investigators will record patients' pain scores, opioid consumption, side~     effects and physical therapy progress.~      If our study proves that the continuous saphenous nerve block in addition to LIA can~     effectively reduce postoperative pain scores to an acceptable level with better physical~     therapy progress and less opioid consumption, it could be seen as a more attractive~     alternative to LIA alone or other traditionally used methods of postoperative pain control~     that compromises muscle strength and physiotherapy.~   "
131653|NCT01332032|"~     This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods~     of reaching out to women who are coming due for or who are overdue for a mammogram. The~     study originally embedded in a community healthcare plan and an associated community clinic,~     now accepts patients using the community clinic and 3 other health care plans. The study~     makes use of a complex computer driven reminder system.~      The study also will examine ways to improve the efficiency and sequencing of the~     interventions by identifying patient factors associated with intervention effectiveness.~   "
131654|NCT01332019|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301~     (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this~     study is to describe long-term multiple sclerosis (MS) outcomes in participants originally~     treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.~   "
131655|NCT01332006|"~     For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant~     is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood~     cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor~     weather related or unrelated. A suitable compatible donor can be found in at least 70% of~     the patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant~     are not able to undergo the procedure because of the lack of a HLA compatible donor. Cord~     blood (CB) cells represent another possible source, that needs a lower degree of HLA~     compatibility. CB transplant, however, offers a lower number of HSC. Thus, adult patient~     rarely may benefit from this source of stem cells, mainly beacuse thie body weight is too~     high to have ad adequate number of cell per kg. Recently, experimental animal models~     confirmed that an adequate recovery of allogeneic hemopoiesis can be achieved via intrabone~     injection, using a 1Log lower number of cells compared to the intravenous way (Yahata 2003,~     Castello 2004). Safety and feasibility of intrabone infusion was verified by two clinical~     studies on humans: the first was conducted by Ringden O. et al. in 18 patients using BM as a~     source of SC. No side effects and complete engraftment of donor hemopoiesis was observed;~     the second one was conducted by Frassoni et al. (Frassoni 2008) with CB as the source of~     HSC.~      The aim of this study is to evaluate the intrabone infusion of compatible CB in patients~     with haematological malignancies lacking a HLA matched donor.~      We will perform:~      evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100~     days, 6 months and 1 year after transplant; studies on immunological reconstitution and the~     role of the NK compartment.~   "
131656|NCT01331993|"~     The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO~     manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as~     VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen~     formulation.~   "
131712|NCT01331265|"~     The goal of this study was to examine the effects of self-perceived lactose intolerance~     (SPLI) as it relates to calcium intake and specific health problems that have been~     attributed to reduced intake of calcium and foods from the dairy group in a nationally~     representative multi-ethnic sample of adults.~   "
131657|NCT01331980|"~     Cystic fibrosis (CF) affects an estimated 30,000 people in the United States and is caused~     by a mutation in the gene encoding a protein called CF transmembrane regulator (CFTR). The~     hallmarks of CF are recurrent pulmonary exacerbations and declining pulmonary function.~     However, there are other problems in CF that affect both health and quality of life. These~     include CF related diabetes, liver disease, and bone disease. The median age of survival for~     patients with CF has been increasing steadily and is currently more than 37 years. With this~     improvement in life expectancy, it has become increasingly important to address the~     long-term complications of CF.~      Currently, patients with CF are evaluated annually for bone disease with dual X-ray~     absorptiometry (DXA), and screening usually starts at age 12. However, this may not be~     sufficient to detect early bone changes that may impact fracture risk. Furthermore, bone~     disease in children may manifest earlier than adolescence, which would suggest that~     screening should start at an earlier age in these vulnerable patients. The following study~     is therefore proposed to examine the potential role of peripheral quantitative computed~     tomography (pQCT) as a screening approach for bone disease in children with CF. The~     investigators expect to find bone problems by pQCT but not DXA.~   "
131658|NCT01331967|"~     Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase~     insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles.~     The effect of pioglitazone on atherosclerotic and inflammatory markers has not been compared~     in prospective manner after everolimus-eluting stent implantation by OCT. The purpose of~     this prospective, randomized, open-label trial is to compare the effect of pioglitazone on~     neointima volume and atherosclerosis progression in type 2 diabetic patients by using OCT.~     Moreover, changes in neointima characteristics could be analyzed along with the changes in~     miRNA-21, -126, -143, -145. Major adverse cardiovascular events such as non-fatal MI, death,~     stroke, and TLR could be compared.~   "
131659|NCT01331954|"~     Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast~     fibroadenoma.~   "
131660|NCT01331941|"~     This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced~     solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of~     renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective~     is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various~     degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5~     weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only~     or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with~     paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.~   "
131661|NCT01331928|"~     The purpose of this study is to determine whether sequential chemotherapy with capecitabine~     plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric~     cancer.~   "
131662|NCT01331915|"~     In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated~     toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.~      The primary objective is to analyze the safety of the inreasing doses of vaccine.~      The secondary objective is to document whether this vaccine can induce tumor regression in~     immunized patients.~   "
131663|NCT01331902|"~     The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of~     maximal coronary hyperemia compared with adenosine.~   "
131664|NCT01331889|"~     Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However,~     potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in~     the reservoir of rapid infusion system and its effect on the plasma potassium change during~     rapid transfusion are unknown. This study is designed to investigate these changes while~     massive transfusion is performed during liver transplantation surgery.~   "
131665|NCT01331876|"~     Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and~     compulsions are the two manifestations of this disease. Obsessions are recurrent anxious~     ideas, and compulsions repetitive behavior aiming to decrease this anxiety.~      OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more~     precisely an hyperactivity of prefrontal cortex / basal ganglia loops.~      Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex,~     anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference~     treatments : medication and Cognitive and Behavioral Therapy (CBT).~      Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They~     are randomised in two groups : one proposing a reference CBT, the other associate CBT to a~     new psychopedagogic task developed by the investigators team.~      Clinical investigations and neuro-imagery data are collected at the main steps of therapies~     : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms~     severity, patients and relatives quality of life are also assessed.~   "
131666|NCT01331863|"~     -  First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day~          morbidity and mortality rates of bronchial transplantation using cryopreserved aortic~          allograft in proximal lung cancer surgery. The investigators hypothesize that this~          stage 1-2 surgical innovation could be safe and effective in order to reduce the 90-day~          morbidity and mortality rates compared to those observed with pneumonectomy, especially~          when some factors are present: age > 70 years, right side, neoadjuvant~          chemoradiotherapy.~        -  Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant~          or benign) lesions of the trachea requiring airway transplantation.~      For these patients, resection followed by direct end to end anastomosis is not possible or~     at high risk.~   "
131677|NCT01331720|"~     The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian~     hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females~     undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro~     fertilisation/intracytoplasmic sperm injection).~      Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and~     urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.~   "
131713|NCT01331252|"~     This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients~     with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent~     position.~   "
133458|NCT01308112|"~     The purpose of this study is to compare the presence of Plasmodium infection in parturient~     women who antenatally received a combination of iron-fortified foods with iron supplements~     versus iron-fortified foods only.~   "
131667|NCT01331850|"~     This randomized, open-label, multi-center study will evaluate the sustained virological~     response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with~     Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection.~     Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders,~     will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized~     to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and~     ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive~     RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group~     2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200~     mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day,~     Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day~     for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus~     Copegus treatment.~   "
131668|NCT01331837|"~     This randomized, open-label, parallel-group, multicenter study will evaluate the rate of~     cardiovascular events with tocilizumab in comparison to etanercept in participants with~     rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8~     milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg)~     etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug~     (DMARD).~   "
131669|NCT01331824|"~     The primary objective of this study is to determine in subjects with metastatic measurable~     bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who~     have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment~     with amrubicin. The secondary objectives will be to evaluate progression-free survival,~     survival at 1 year, and the safety of amrubicin as second-line therapy in patients with~     metastatic urothelial carcinoma.~   "
131670|NCT01331811|"~     Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the~     difficulty of its diagnosis is increased in case of HIV infection in children.~      The aim of this study is to improve TB diagnosis in HIV-infected children by developing a~     new diagnostic algorithm incorporating new tools available such as:~        -  interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test~        -  alternative specimen collection methods such as string test (or Enterotest (R)),~          nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate~        -  the Xpert MTB/RIF assay~   "
131671|NCT01331798|"~     A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study~     the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the~     management of wound drainage during abdominoplasty procedures.~   "
131672|NCT01331785|"~     Ascites is a frequent complication of patients with portal hypertension. As portal~     hypertension progresses, a percentage of these patients develop refractory ascites.~     Management options at that point include either TIPS or intermittent large volume~     paracentesis (LVP), with its attendant risks, Portal hypertension is accompanied by systemic~     circulatory dysfunction (decreased systemic vascular resistance and systolic BP), which is~     exacerbated by large volume paracentesis, with resultant renal and cardiac dysfunction.~     There are limited options for managing patients with acute decompensation, such as~     hepatorenal syndrome, although midodrine and other vasoconstrictors have been used in such~     patients. Midodrine has not been used as a possible therapeutic for ascites. Midodrine~     however, has been found to change the hemodynamics related to portal hypertension and~     ascites. There has been also change in mediators related to renal and circulation in studies~     of short duration (7 days) but not found in studies of 1 month duration, however the~     clinical effects of midodrine is found for longer duration in other similar conditions.~      The purpose of the study is to assess the utility of midodrine in patients with obvious~     systemic circulatory dysfunction (hypotension) in improving the outcome of patients with~     refractory ascites and change in hemodynamic parameters and its mediators.~      Specific endpoints include:~      1) an objective reduction of the volume/rate of accumulation of ascites and 2) a decrease in~     the frequency of LVP.~   "
131673|NCT01331772|"~     Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or~     obesity, physical inactivity and alcohol consumption are risk factors commonly associated~     with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced~     physical activity is one factor likely to weight gain in women after adjuvant chemotherapy~     for localized breast cancer. Furthermore, physical activity appropriately could improve many~     prognostic factors and survival of women after breast cancer. Adapted Physical Activity~     (APA) could improve fitness, quality of life, body image, treatment compliance and reduce~     fatigue.~      After diagnosis of breast cancer, there is many possible risk factors of mortality or~     morbidity related to nutritional factors available to management. These risks prevention~     through management of these patients appears indispensable through an APA program.~      Thus, the investigators propose to test the feasibility of implementing a program of dietary~     intervention and APA to prevent the risk of weight gain (which affects more than half of~     patients) and maintain and/or increase their level of physical activity during and after~     adjuvant chemotherapy.~   "
131674|NCT01331759|"~     Neuropattern™, a new diagnostic tool for stress related disorders is being applied in a~     demanding workplace environment. Neuropattern™ aims at identifying stress-related bodily~     changes at an early stage. By identifying subgroups based on Neuropattern™ subjects gain~     access to online counseling specified according to their Neuropattern™ diagnosis. Efficacy~     is being assessed by several questionnaires in a follow-up.~   "
131675|NCT01331746|"~     A study to look at the effectiveness of a drug called APD515, designed to be applied to the~     lining inside the mouth, at relieving dryness of the mouth. Study will compare one week of~     treatment with APD515 to one week of treatment with matching placebo to see which has better~     effect on patient's mouth dryness, according to their own score.~   "
131676|NCT01331733|"~     To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary~     gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in~     females undergoing intrauterine insemination.~      Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be~     more effective than monotherapy.~   "
133090|NCT01313286|"~     The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in~     terms of how much gets into the blood stream and how long it takes the body to get rid of~     it. Information about any side effects that may occur will also be collected.~   "
131678|NCT01331707|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease~     has led to a significant reduction in morbidity but there are further demands on DES~     performance. Such demands are an optimized performance in very challenging coronary lesions;~     third generation DES were developed in an effort to further improve DES performance in such~     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus~     Element stents) are currently available; there are no data that indicate an advantage of one~     of these DES over the other.~   "
131679|NCT01331694|"~     To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially~     insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD~     population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg~     compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide~     (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).~      This is a hypothesis testing study~      Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC~     and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO~     and FSC and IP~      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:~      Ho: There is no difference in COPD-related costs between FSC and TIO and FSC and IP Ha:~     There is a difference in COPD-related costs between FSC and TIO and FSC and IP~   "
131680|NCT01331681|"~     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the~     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy~     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement~   "
131681|NCT01331668|"~     This study aims to maintain a prospective biobank of human samples obtained from donors and~     recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine~     samples.~   "
131682|NCT01331655|"~     The objective of this three-arm study is to evaluate the effect of a flexible extended~     regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance~     with daily pill intake when the investigational product is provided in a blister package or~     a compliance aiding dispenser with a pill reminder function. The third treatment arm will be~     a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.~   "
131683|NCT01331642|"~     Gaucher disease is an autosomal recessive hereditary lysosomal storage disorder. Occurrence~     of the disease is due to a hereditary deficiency of the Glucocerebrosidase, a lysosomal~     enzyme which divides Glucocerebroside in to Glucose and Ceramides.~   "
131684|NCT01331629|"~     The purpose of this study is to compare intervention by Art-therapy to standard care in~     patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.~   "
131685|NCT01331616|"~     Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy~     lead to optic neuropathy?~   "
131686|NCT01331603|"~     Recently, it has been demonstrated that iron overload is associated with the appearance of~     labile plasma iron (LPI).~      LPI is redox active and is rapidly taken up by cells, leading to a rise in the labile iron~     pool (LIP) and catalyzing generation of reactive oxygen species (ROS), which can lead to~     cellular damage.~      The LPI data are mostly derived from thalassemia iron overload research , however, there are~     a few data describing LPI and its correlations with the classical iron overload parameters~     (ferritin, TSAT) in acute anemias such as MDS Therefore we are going to assess LPI in iron~     overloaded myelodysplastic syndromes (MDS) (low and high risk) and primary myelofibrosis, in~     order to assess whether it can be used as alternative to the routinely used parameters; TSAT~     and ferritin levels.~   "
131687|NCT01331590|"~     The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow~     microenvironment as a means to increase the efficacy of chemotherapy in patients with~     relapsed or refractory acute lymphoblastic leukemia (ALL).~   "
131688|NCT01331577|"~     Stress is a common problem with significant consequences for health. It can be a trigger for~     somatic diseases as well as psychological disorders and leads through missed working days~     and healthcare cost to a high economic loss. It is for health and economic reasons essential~     to develop and evaluate effective interventions that can inoculate against stress and build~     inner strength.~      A cognitive-behavioural training for groups that is well evaluated and has shown to be~     effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of~     methods of the complementary and alternative medicine is increasing a rigorous evaluation is~     needed. Integrative Kinesiology is a popular method that has been said to be effective~     against stress and its symptoms.~      The investigators propose a randomized controlled evaluation and comparison of the~     interventions to each other and to a waiting-list control group. Hypothesis: Healthy~     volunteers attending a two dayseminar will show significantly reduced psychobiological~     reactivity, decreased stress perception and less anxiety to a standardized psychosocial~     stress test compared to the waiting list group. A total of 64 healthy volunteers will be~     randomly assigned to one of the three groups. The efficacy of the interventions will be~     measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress~     reactivity.~   "
131689|NCT01331564|"~     The project aims to develop, implement and evaluate electronically-mediated behavioral~     intervention programs for pregnant and postpartum women in order to prevent excessive weight~     gain during pregnancy and postpartum weight retention.~   "
131690|NCT01331551|"~     The purpose of this study is to investigate the relationship of high exposure to dibutyl~     phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male~     fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and~     sncRNAs, and reproductive hormones.~      Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm~     concentration and motility, and increased sperm DNA damage.~      Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum~     testosterone, altered LH:testosterone ratio, and decreased inhibin-B.~      Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered~     transcript profiles of sperm mRNAs and sncRNAs.~   "
131710|NCT01331291|"~     For many brain tumors, one reason that chemotherapy drugs might not be effective is that the~     drug may not be able to get into the brain tumor and kill the cancer cells. The brain is~     protected by a layer called the blood brain barrier. This barrier prevents substances from~     entering. The purpose of this research study is to determine if bosutinib can get past the~     blood brain barrier and into the brain tumor, and to see how well bosutinib works in killing~     cancer cells.~   "
131691|NCT01331538|"~     The aim of this research was to determine the existence of a correlation between the degree~     of temporomandibular dysfunction and cervical posture in different occlusal classes in~     adolescents. A cross-section, observational study was carried out, in which 296 adolescents~     took part. For the evaluation, the patients were divided into groups according to the~     presence and severity of the temporomandibular dysfunction, using a questionnaire and~     occlusal Angle classification. The posture analysis was carried out using photogrammetry and~     the software Alcimage® to measure the predefined angle based on the protuberances of the~     Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum~     Vertex.~   "
131692|NCT01331525|"~     This trial will investigate the addition of an antibody (Ipilimumab) to conventional~     Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.~      The primary objective is to establish the progression free survival at 1 year.~   "
131693|NCT01331512|"~     Background:~      - Older persons are often referred to physicians because of mobility difficulties that grow~     worse as they age. To better understand the reasons for mobility difficulties in older~     persons, researchers conducted a population-based study of individuals living in the Chianti~     geographic area of Tuscany, Italy. Researchers are now interested in conducting a follow-up~     study on the original participants to assess the effects of aging on their mobility.~      Objectives:~      - To conduct a follow-up study on the participants in the mobility study of older persons in~     the Greve in Chianti and Bagno a Ripoli areas near Florence, Italy.~      Eligibility:~      - Original participants in the InChianti Mobility Study.~      Design:~        -  The InChianti Follow-up Study will repeat most elements of the baseline evaluation from~          the original study. Participants will be seen on the 3-year anniversary of their~          baseline study assessment.~        -  Participants will have a home interview with questions about their physical and mental~          health, family history, daily activities, and living conditions related to their~          continued mobility.~        -  Participants will provide blood and urine samples, and will have tests of heart and~          motor nerve function and imaging studies of bones and the circulatory system.~        -  Participants will also have a functional evaluation of their motor skills, including~          walking tests, range of motion tests, and grip strength.~   "
131694|NCT01331499|"~     The purpose of this study is to compare standard of care hemostasis techniques with and~     without the use of Aquamantys in reducing peri-operative blood loss.~   "
131695|NCT01331486|"~     Prehypertension and mild hypertension affect an estimated 157 million U.S. adults.~     Cardiovascular disease (CVD) risk and associated mortality is elevated in this population.~     Treatment options are limited consisting of lifestyle modification, which is often~     ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious,~     and acceptable treatment options for this population are needed. Hawthorn standardized~     extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence~     suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn~     have based dosage recommendations on animal studies. Therefore, the investigators propose a~     dose-finding study to measure the pharmacodynamic effect of three doses of standardized~     hawthorn extract and placebo.~   "
131696|NCT01331473|"~     To compare the incidence of new ischemic brain injury detected with magnetic resonance~     imaging (MRI) after carotid artery stenting in patients treated with and without proximal~     cerebral protection (Gore Flow Reversal System).~   "
131697|NCT01331460|"~     The purpose of this study is to determine how drug abuse treatment interventions can be~     integrated with established Human Immunodeficiency Virus prevention approaches to optimize~     their combined effectiveness.~   "
131698|NCT01331447|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fasted conditions~   "
131699|NCT01331434|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fed conditions.~   "
131700|NCT01331421|"~     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under~     fasted conditions~   "
131701|NCT01331408|"~     The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume~     restoration and shaping of the buttocks.~   "
131702|NCT01331395|"~     The purpose of this study is to determine the value of combining Traditional Chinese~     Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).~   "
131703|NCT01331382|"~     Resveratrol is associated with a plethora of physiological effects in humans, including~     modulation of cerebral blood flow, despite apparently poor bioavailability. This study~     investigated whether the physiological effects of resveratrol could be affected when~     co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability~     of resveratrol.~   "
131704|NCT01331369|"~     The aim of the study is to evaluate the effectiveness of a social-psychological intervention~     to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.~   "
131705|NCT01331356|"~     The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in~     refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ®~     in the ganglion Impar (total dose = 100 units)~   "
131706|NCT01331343|"~     The purpose of this study is to determine whether Type 1 diabetic patients using the~     Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to~     patients using self-monitoring blood glucose testing (SMBG) alone.~   "
131707|NCT01331330|"~     To evaluate the effects of two different programming settings of deep brain stimulation~     (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for~     TR-MDD, single or recurrent episode on mood as measured by the MADRS.~   "
131708|NCT01331317|"~     The primary objective is to assess the impact of three months of treatment with an active~     vitamin D analogue on a risk marker for excess overall mortality and cardiovascular~     morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis~     is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and~     mortality in patients with type 1 diabetic kidney disease.~   "
131709|NCT01331304|"~     The purpose of this study is to compare the effectiveness of lithium and quetiapine for the~     treatment of individuals with bipolar disorder.~   "
133491|NCT01307657|"~     The purpose of this study is to determine whether a high-fat meal affects the ability of~     platelet function tests to measure platelet inhibition by clopidogrel.~   "
131714|NCT01331239|"~     This exploratory study is a proof of concept study to determine whether LCI699 can safely~     reduce the level of urinary free cortisol in patients with Cushing's disease. In addition,~     this study will evaluate the long term efficacy and safety of LCI699 including an additional~     12 week of treatment followed by a 12 month long term optional extension. A second extension~     will provide patients who are clinically benefitting from LCI699 an opportunity to continue~     to have access to the drug until LCI699 is commercially available and reimbursed or through~     the availability of a local access program.~   "
131715|NCT01331226|"~     This study is designed to examine if a telephone-based intervention delivered to a support~     person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota~     helpline. In addition, the study will examine if the rate of smoker calls to the helpline is~     greater if the support person receives 3 intervention calls, 1 intervention call, or no~     calls (written materials only, control condition).~   "
131716|NCT01331213|"~     The general aim of the current study is to describe the effect of pregabalin on colonic and~     sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C).~      Study hypotheses:~        1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation~          ratings in response to balloon distension in the colon relative to pre-pregabalin~          treatment.~        2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic~          pain and gas thresholds in patients with irritable bowel syndrome constipation~          predominant.~        3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a~          standardized meal.~   "
131717|NCT01331200|"~     The purpose of this study is to study the safety and feasibility of mobilization of acute~     ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.~   "
131718|NCT01331187|"~     Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical~     department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia,~     hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall~     bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic~     tool in these diagnosis, and on early diagnosis is crucial with respect to the patients~     well-being and inpatients workflow.~      1. The aim is to study the clinical use of pocket-size US as a screening diagnostic tool in~     an medical department with respect to inpatients workflow and diagnostics.~      Method: Patients admitted (in certain preset periods) to Department of medicine will be~     randomized to routinely adding an ultrasound examination with pocket-size device by~     residents on call. Time to definitive diagnosis, time to definitive treatment and time to~     discard will be recorded. US findings will be validated against standard echocardiography,~     or standard US/CT/MRI performed at the Radiological department.~   "
131719|NCT01331174|"~     Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment~     in different doses and to compare to the control and placebo group.~      Background: Several forms of conservative treatment have been the focus of many recent~     studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short~     wave has been widely used, but the optimal dose and application time still have not been~     well established.~   "
131720|NCT01331161|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection~     in the elderly in particular. This could be explained by a defect in the early responses of~     an ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the~     geriatric population.~      In this trial, the investigators will study the immunologic differences of the FDA approved~     licensed shingles vaccine between a younger and an older group. Thirty three healthy~     volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of~     60-79 will be enrolled in the study. Each participant in the study will be given one~     shingles shot. Blood work will be obtained one month before vaccination, on the day of~     vaccination, one day, three days, seven days, fourteen days, one month, three months and six~     months after vaccination. Throughout the duration of the study, the participants will be~     monitored for safety.~   "
131721|NCT01331148|"~     Vitamin D deficiency (VDD) is very common among African American adolescents and adults in~     the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell~     disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle~     weakness. The investigators believe VDD may contribute to poor musculoskeletal health and~     chronic pain seen in pediatric SCD. In this study, the investigators aim to show that~     children and adolescents with SCD and chronic pain have lower levels of vitamin D compared~     to those without chronic pain. The investigators also aim to determine the clinical~     characteristics in SCD patients related to their vitamin D status.~      About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain~     and 30 without chronic pain. The investigators will assess baseline characteristics~     including vitamin D levels, bone turnover rates (measured by C telopeptide blood levels~     [CTx]), markers of inflammation and oxidative stress levels in blood, baseline hemoglobin~     and other laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary~     function, opioid analgesic use, overall muscle strength, quality of life and depression.~      To evaluate the impact of vitamin D replacement on these baseline characteristics, the~     investigators will randomize subjects to receive either placebo or high dose vitamin D for 6~     weeks after which time the investigators will evaluate overall vitamin D status, muscle and~     bone health, depression, quality of life, pain status and use of opioid pain medications,~     inflammation and oxidative status comparing before and after treatment with high dose~     vitamin D. The investigators will give—at no cost to subjects—a daily supplement that will~     provide the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium~     and 200IU vitamin D to subjects throughout the study period. Subjects will be in the study~     for 7 months and have five to six study visits.~   "
131732|NCT01331005|"~     This study is being conducted to assess the effects of topical nonsteroidal~     anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with~     non-central diabetic macular edema (DME). A secondary objective of this study is to assess~     the effects of topical NSAIDs on central subfield thickness and to compare the progression~     of non-central DME to central DME as determined by optical coherence tomography (OCT) and~     stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to~     determine whether the conduct of a phase III trial has merit based on an anatomic outcome,~     (2) to estimate recruitment potential of a phase III investigation, and (3) to provide~     information on outcome measures needed to design a phase III trial. The study is not~     designed to establish the efficacy of NSAIDs in the treatment of non- central DME.~   "
131899|NCT01328769|"~     In this study the investigators will recruit hypertensive subjects with higher than average~     uric acid levels to test the effect of lowering uric acid with febuxostat on several~     measures as listed below. This will be a randomized, double-blind, placebo-controlled,~     parallel group study.~   "
131722|NCT01331135|"~     The best treatment for recurrent cancers or those that do not respond to therapies is not~     known. Typically, patients with these cancers receive a combination of cancer drugs~     (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but~     may not offer a long-term cure.~      This study proposes using a drug called Sirolimus in combination with common chemotherapy~     drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found~     to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous~     studies and, therefore, has the potential to increase the effectiveness of the chemotherapy~     drugs when given together.~      This study wil investigate the highest dose of Sirolimus that can be given orally with other~     oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose~     will be increased in the next 2 subjects as long as there were no major reactions in the~     previous groups. This study will also seek to learn more about the side effects of sirolimus~     when used in this combination and what effects the drug has on the white cells and the~     immune system. Successful use of this drug will impact the cancer population greatly by~     providing an increased chance of survival to those with resistant or recurrent cancers.~   "
131723|NCT01331122|"~     Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also~     called motor blocks, FoG is characterized by a sudden inability to move the lower~     extremities which usually lasts less than 10 seconds. The exact pathophysiology of FoG is~     poorly understood, but treatment with levodopa appears to improve FoG observed in the~     off-state. As Parkinson's patients progress in severity, FoG in the on-state can increase in~     frequency and appears to be resistant to dopaminergic therapies. There is additional~     evidence that norepinephrine as well as dopaminergic systems may be involved in FoG.~      Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or~     dizziness associated with Parkinson's Disease. This study is to further explore the safety~     and efficacy of droxidopa in this indication.~   "
131724|NCT01331109|"~     The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in~     pediatric patients aged 13 to 17 years with primary fibromyalgia.~   "
131725|NCT01331096|"~     Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will~     be performed using an automated anesthesia delivery system; preoperative and intra-operative~     assessment of patients will be performed via video-conferencing from Montreal, which will~     also monitor and control anesthesia delivery via distant Internet connection - as~     supervision of functioning of the automated anesthesia delivery system. In the control group~     anesthesia will be performed in a standard fashion with manual control of the syringe pumps~     infusing anesthetics drugs.~      The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic~     control of an automated anesthesia delivery system is feasible and reliable via standard~     means of internet communication (distant control via virtual network) and performed as well~     or even better than manual control of the anesthetic drugs infusion.~   "
131726|NCT01331083|"~     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of~     your prostate cancer. The investigators will also watch you carefully for any side effects~     that PX-866 might cause.~   "
131727|NCT01331070|"~     Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non~     reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking,~     which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the~     sixth leading cause of death in 1990. It is projected to be the fourth leading cause of~     death worldwide by 2030 due to an increase in smoking rates and demographic changes in many~     countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations~     per year and the health care expenditure of COPD in France is 3.5 billion of Euros.~     Classical markers of the disease severity, the forced expiratory volume in one second,~     poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control~     of breathing in an attempt to understand the pathophysiological mechanisms involved in the~     progression of the disease. Breathing control is enhanced in patients with COPD due to the~     progressive failure of respiratory muscles (airflow obstruction, static and dynamic~     hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion~     ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command~     depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect~     method of breathing control estimation suggested in COPD patients an increased excitability~     of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve.~     This may represent an increase risk factor for acute respiratory failure. Until now, no~     study reported the central breathing control with cerebral fMRI in COPD patients.~   "
131728|NCT01331057|"~     The primary purpose is the validation of an instrument of the first language assessment. The~     second purpose is to study the impact of familial and transcultural factors on early~     bilingualism in migrant children born in France.~   "
131729|NCT01331044|"~     1. RUTF would be more effective (quicker catch-up growth by promoting more tissue accrue~          resulting decrease stay in rehabilitation ward) in treating children with SAM during~          the rehabilitation phase than khichuri /halwa;~        2. RUTF would be acceptable to the children and their mothers/caregivers;~        3. Malnutrition is not caused solely by lack of food, but also by impaired utilization of~          the food that is ingested. The ability of the gut to absorb nutrients from the diet is~          associated with the host's 'human' genotype, the host's gut microbiota and its gene~          content (the microbiome).~   "
131730|NCT01331031|"~     The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse~     symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms~     of TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled~     in public school . The investigators used the questionnaire for selection of orofacial pain~     and temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess~     the presence or absence of signs and symptoms of TMD.~   "
131731|NCT01331018|"~     This pilot trial will access the toxicity and efficacy of infusion of gene modified cells~     for patients with Fanconi anemia (FA). Infusion of autologous patient blood stem cells that~     have been corrected in the laboratory by introduction of the normal gene may improve blood~     counts in patients with FA.~   "
131773|NCT01330459|"~     The purpose of this study is to determine whether preoperatively administered~     hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.~   "
131733|NCT01330992|"~     The mammalian eye serves both visual and non-image-forming functions. New information about~     the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light~     stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes,~     cognitive performance, alertness and sleep. The results of the proposed work can be used to~     make predictions about the effects of light, to make recommendations involving exposure to~     or avoidance of light, and to design environmental lighting, resulting in improved health~     and alertness and decreased errors and accidents.~   "
131734|NCT01330979|"~     An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy~     of AR-12286 in patients with open-angle glaucoma or ocular hypertension~   "
131735|NCT01330966|"~     The purpose of this study is to determine the effectiveness and safety of single agent~     pazopanib in subjects with chondrosarcoma.~   "
131736|NCT01330953|"~     The purposes of this study are (1) To determine the safety of LY2928057 in healthy people,~     and any side effects that might be associated with it; (2) To understand how the body of~     healthy people handles LY2928057; (3) To determine the effect of LY2928057 on blood iron~     level in people's body; and (4) To evaluate how people's immune system reacts to LY2928057.~   "
131737|NCT01330940|"~     Beverages containing citrate may be useful in increasing urine citrate content and urine pH.~     Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more~     citrate than other similar beverages. The investigators are interested in whether diet soda~     will improve urine chemistry in the appropriate manner.~   "
131738|NCT01330927|"~     The purpose of this study is to establish the dose response relationship of VA106483 and~     nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic~     Hypertrophy (BPH) who are likely to present with nocturia.~   "
131739|NCT01330914|"~     Obesity is a chronic illness of staggering proportions. Because weight loss through diet and~     exercise is difficult to attain and maintain, there has been escalating interest in~     bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in~     long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased~     mortality. Emerging evidence suggests, however, that gastric bypass may have negative~     effects on bone health. Because of the serious consequences of osteoporosis and fracture,~     this is of great concern. This study of the effects of gastric bypass on calcium metabolism~     and the skeleton may positively impact the clinical care of gastric bypass patients by their~     surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may~     inform future investigation into the relationships between obesity, weight loss, and bone~     biology.~   "
131740|NCT01330901|"~     This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal~     antibody against interleukin 12 and 23) treatment in patients with active ankylosing~     spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate~     response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not~     tolerate or have a contraindication for NSAIDs.~   "
131741|NCT01330888|"~     The purpose of this 2-year pilot study is to explore the impact of deployment on the~     psychosocial and health characteristics and reintegration of Military Chaplains,~     specifically those of the Army National Guard (ARNG). This pilot will serve as the~     foundation for subsequent investigations of chaplains from multiple branches of the~     military. In addition to spiritual and religious support, Military Chaplains play a key role~     in the behavioral health of deployed service-members, routinely participating in suicide~     prevention training, conducting critical event debriefing, and identifying service-members~     at risk for combat and operational stress reactions1. A high risk group for exposure to~     trauma2, Military Chaplains have suffered brain injuries, gunshot wounds and blast injuries~     in OEF/OIF Theater3. In addition, many report combat related stress issues such as~     compassion fatigue, PTSD, and reintegration issues3. While the traumatic experiences of~     OEF/OIF deployed troops have been well documented, the effects on military chaplains caring~     for these service-members have received little attention in the research to date. We are~     collaborating with the National Guard Chaplain Corps Leadership on this program of research.~     The aims of this 2-year pilot cross-sectional study focus on describing and exploring~     deployment and its impact on psychosocial, health characteristics and reintegration of ARNG~     chaplains using a mixed method approach (web-based survey, in-depth interviews, social~     network analysis).~   "
131742|NCT01330875|"~     Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will~     have to answer questions concerning their pain. (The lumbar infiltration itself is not part~     of this study)~   "
131743|NCT01330862|"~     The study is to provide accurate, reliable information on NSCLC clinical management across~     MENA (Middle East North Africa) countries in order to detect unmet medical needs of this~     disease, it is a purely observational study; therefore patients are not assigned to a~     particular therapeutic strategy beforehand by a protocol. Treatment will be according to~     current clinical practice.~   "
131744|NCT01330849|"~     The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for~     school behaviour modification in primary school children with ADHD-behaviours) in terms of~     general improvement in ADHD symptoms, specific targeted school-related problem behaviours,~     other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child~     relationship and child self-esteem.~   "
131745|NCT01330823|"~     The study investigated the role of L-Carnitine supplementation on proinflammatory immune~     response, malnutrition, cancer cachexia and cancer related fatigue in advanced and~     inoperable pancreatic cancer, UICC Stage IV .~   "
131746|NCT01330810|"~     Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths~     in the United States. A safe and effective preventive agent could reduce the burden of~     colorectal cancer as well as reduce the costs associated with screening patients who are at~     high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active~     against multiple pathways implicated in tumor initiation, progression, and metastasis.~     However, little is know how curcumin performs in humans. The investigators propose to enroll~     12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin~     administration. The investigators will look at curcumin preparations with low and high oral~     bioavailability and calculate the blood and rectal tissue concentrations associated with~     these two formulations to determine which preparation produces the highest tissue~     concentrations.~   "
131747|NCT01330797|"~     Purpose To evaluate the cataractogenic effect of intravitreal ranibizumab with the use of~     Lens Opacity Classification System III (LOCS III).~      Settings Cases with a diagnosis of wet AMD were included in this university practice based~     prospective study.~      Methods All cases had monthly injections of intravitreal ranibizumab in the first 3 months;~     subsequently an OCT-guided pro re nata injection regimen has been adopted. All cases had a~     comprehensive eye examination and LOCS III evaluation at baseline and 1, 3, 6 and 12 months~     after the initial injection. Examination outcomes and change from baseline in LOCS III~     grades at 12 months were recorded.~      Results Eighteen eyes of 13 cases (7 female, 6 male) were included in this study. The mean~     age at the baseline was 75,3 + 6,6 years. A mean of 3,4 + 0,7 injections were given on each~     eye. Mean follow-up was 13,83 + 2,33 months. Baseline mean visual acuity improved from 1,04~     + 0,10 logMAR units to 0,76 + 0,26 logMAR units after 3 injections (P < 0.05). At the 12th~     month of follow-up mean visual acuity was 0,71 + 0,27 logMAR units. According to LOCS III~     grades none of the cases had a prominent change in nuclear color, nuclear opalescence,~     cortical and posterior subcapsular opacification throughout the follow-up. IOP remained~     stable at all follow-up points. No complications were recorded throughout the study.~      Conclusion Intravitreal ranibizumab is an efficient treatment in wet AMD. Results of LOCS~     III assessments in this pilot study suggest that intravitreal ranibizumab has no effect on~     the progression of lens opacity.~   "
131748|NCT01330784|"~     To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary~     gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.~      Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins~   "
131749|NCT01330771|"~     To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary~     gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females~     undergoing IVF.~      Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins~     + recombinant gonadotrophins~   "
131750|NCT01330758|"~     A study to compare two different tablet formulations of AZD8931 in healthy males and~     females.~   "
131751|NCT01330745|"~     The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric~     microcirculatory function, using sublingual evaluation, in cardiac surgery.~   "
131752|NCT01330732|"~     The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral~     x-rays of the spine in patients monitored for kyphosis.~   "
131753|NCT01330719|"~     Although of low prevalence, aggressive periodontitis is a rapid destructive form of~     periodontal disease that initiates at a young age, leading to premature loss of first molars~     and incisors. Little is known on the mechanisms of this disease. It is imperative to~     understand mechanisms of disease to establish proper treatment. We have established a~     controlled study in a comparable population presenting similar aggressive disease~     characteristics to evaluate the mechanisms of this disease. It is the goal of this study to~     determine immunological and microbiological mechanisms responsible for the rapid tissue~     destruction in children with localized aggressive periodontitis and how traditional~     periodontal intervention affects these mechanisms. Important knowledge gained with this~     proposal will aid in defining specific treatment approaches to better control disease~     progression and prevent disease initiation in susceptible individuals.~   "
131754|NCT01330706|"~     The investigators conducted a controlled, prospective randomized study to examine the~     antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.~   "
131755|NCT01330693|"~     The purpose of this study is to find out if children with attention-deficit, hyperactivity~     disorder (ADHD) have a difference in how their brain cells fire or react. The~     investigators also want to find if brain cell firing can tell us how severe of symptoms a~     child has from ADHD. Finally, the investigators want to see if giving an ADHD medication~     called atomoxetine can make the ADHD symptoms in a child better and if the improvement shows~     a change in brain firing.~   "
131756|NCT01330680|"~     Cardiovascular and neuropsychologic effects of coffee are still debated. The precise~     mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic~     systems is incompletely understood and a considerable variability in the response to coffee~     drinking was observed, in part ascribable to a genetic trait.~      The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of~     coffee and explore whether such effects are influenced by the genetic asset of caffeine~     metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by~     polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine~     receptors (by polymorphisms of adrenergic receptors).~   "
131757|NCT01330667|"~     The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively~     breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3~     mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for~     Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc~     extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or~     to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to~     assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is~     that limited, small amounts of formula administered without a bottle immediately following~     breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at~     increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.~   "
131758|NCT01330654|"~     Beta blockers have been shown to decrease the risk of intraoperative cardiac events in~     patients at high cardiac risk. However, they have also been associated with side effects~     (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk~     undergoing surgery is controversial. Heart rate variability is a way of evaluating the~     cardiac function of a patient. Decreased heart rate variability is associated with early~     cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It~     has been shown to transiently decrease in patients in hemorrhagic shock after trauma and~     returns to normal after resuscitation in trauma and burn patients. The investigators~     hypothesize that beta blockers will maintain pre operative heart rate variability in~     patients with intermediate risk of cardiac events during operative intervention with~     laparoscopic surgery.~   "
131774|NCT01330446|"~     The goal of this clinical research study is to learn if armodafinil can reduce fatigue and~     other common symptoms in patients that have received treatment for head and neck cancer.~   "
131759|NCT01330641|"~     This study attempts to determine the most accurate route for injection of the subacromial~     bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the~     routes of injection is used. It has not been determined if one route is superior, or if all~     routes are equal in delivering medication into the subacromial bursa, which sits on top of~     the rotator cuff tendons.~   "
131760|NCT01330628|"~     The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with~     balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee~     peripheral artery in-stent restenosis.~   "
131761|NCT01330615|"~     Aims:~      The investigators main purpose is to assess the efficacy of analgesia provide by topical~     lidocaine/prilocaine cream 5% (EMLA)® to pared plantar warts prior to application of liquid~     nitrogen cryotherapy in adults.~   "
131762|NCT01330602|"~     The primary objective of this study is, to instigate a reduction in atherosclerotic burden~     within the carotid arteries in the intervention group compared to the control group and to~     demonstrate parallel improvements in cardiovascular and overall health status relative to~     usual care~   "
131763|NCT01330589|"~     The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who~     are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved~     pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing~     agent, St. John's wort, as compared with placebo.~      Hypothesis~        1. Reduced platelet reactivity is present in patients receiving St. John's wort as~          compared to placebo when utilized in combination with clopidogrel~        2. The combination or St. John's wort and clopidogrel results in enhanced platelet~          inhibition~   "
131764|NCT01330576|"~     Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical~     illness in neonates with severe necrotizing enterocolitis.~   "
131765|NCT01330563|"~     The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic~     characteristics of CKD-501 in healthy subject.~   "
131766|NCT01330550|"~     The increase in diabetic population of the world is among the top ten causes of death; with~     diabetes always high on the list of causes of death. Diabetes is always relative to other~     major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal~     disease).~      The eating habits and patterns of the diabetic patient are the main causes for poor glycemic~     control. In epidemiological studies, high fiber and low sugar dietary intake can~     significantly reduce the incidence of diabetes.~      The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in~     regulating blood glucose in pre-diabetic subjects.~      The study will be conducted in three periods:~      Period-I:~      The recruitment of 60 pre-diabetic subjects:~      Subjects of blood glucose levels Impaired fasting glucose; IFG: fasting blood glucose ≧~     100 mg / dL, < 126 mg / dL or Impaired glucose tolerance; IGT: 2 hours postprandial blood~     glucose ≧ 140mg/dL, < 200 mg/dL or clinically judged to be mild or moderate diabetes~     mellitus (HbA1c < 9%).~      In addition to perform pre-test, all subjects also need to complete nutrition counseling and~     nutrition education .~      All 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group,~     normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group,~     high fiber and sugar free biscuit group)~      The period-II:~      Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit~     group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.~      Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30~     subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of~     fiber) daily.~      Post-period:~      Blood samples of all 60 subjects will be collected to compare with period-I and period-II at~     the first day of 9th week.~      Report of expectation:~      The purpose of this study is to help the pre-diabetic subjects to reduce the risk of~     becoming diabetic through the consuming of high fiber and sugar free biscuits and nutrition~     education.~   "
131767|NCT01330537|"~     The topological perception theory proposed a precise description for how one organizes the~     visual world that eliminates the vagueness of subjective phenomenology. In addition, the~     topological theory challenges the dominant computational view on the part-to-whole hierarchy~     of visual information processing. Lines of evidence from adult psychophysics, brain imaging~     data, and even honeybee's behavior have supported the notion that the global topological~     properties are the very primitives of visual representation. However, the question of how~     the sensitivity to topological properties originates during development has not been~     explored much. In a previous study, the investigators found that 2- to 6 month old infants~     could reliably discriminate stimuli based on topological differences, but failed to do so~     based on geometric differences. Using familiarization/novelty preference procedure, the~     present study intends to explore the visual sensitivity for topological properties in~     newborn infants. Experiment 1 focuses on whether neonates can discriminate a disk (no hole)~     and a ring (with a hole) that are topologically different, and/or a disk (no hole) and a~     triangle (no hole) that are geometrically different. Experiment 2 focuses on whether~     neonates can detect a change in the number of holes and/or the size of the hole. If newborn~     infants are only sensitive to topological properties and not to geometric properties, this~     will be a strong proof for the claim that topological property is the very primitive~     visual representation at empirical as well as theoretical level.~   "
131768|NCT01330524|"~     In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic~     Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema~     and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly~     divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be~     injected trough vitreal and placebo will be injected in control group. BCVA and Visual field~     will be then measured in these two groups.~   "
131769|NCT01330511|"~     Patients with congenital hydronephrosis will be identified by inpatient consultations~     performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with~     congenital hydronephrosis of Dr. Assadi's existing patients. Given standard evaluation will~     be evaluated to determine if based on initial ultrasound classification an algorithm can be~     developed to target evaluation studies for the initial evaluation. With a goal of targeting~     the few children that have need of additional intervention and minimizing the studies~     performed on children who will spontaneously resolve.~   "
131770|NCT01330498|"~     This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed~     to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical~     sample collection with MRI and relapse analysis of a Tysabri patient cohort. The study hopes~     to identify secondary and tertiary risk stratification markers that would aid in the~     clinical management of patients who are JC antibody positive.~   "
131771|NCT01330485|"~     Nested within a longitudinal study investigating emotion regulation skills and subsequent~     depressive symptoms in major depressive disorder, the effectiveness of a systematic affect~     regulation training (ART; Berking, 2010) is evaluated in a randomized controlled trial.~   "
131772|NCT01330472|"~     Study to evaluate if Xanax sustained release tablets manufactured at two different sites~     provide similar drug levels in the blood.~   "
131775|NCT01330433|"~     This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate~     the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene~     glycol on the formation of mediastinal and pericardial adhesions in children undergoing~     staged surgical reconstruction (potential procedures include: Blalock-Taussig Type~     Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally,~     bleeding will be evaluated by drainage post-operatively through surgical site drainage~     output.~   "
131776|NCT01330420|"~     The linkage between the Massachusetts General Hospital (MGH)-Community Health Associates and~     the MGH-Benson Henry Institute for Mind-Body Medicine began in order to address the concern~     of providing affordable, easily accessible, culturally appropriate behavioral medicine~     interventions for low income patients served by MGH Community Health Centers, as well as the~     desire to demonstrate the efficacy and economics of these interventions. Since depression~     was such a prevalent issue among health center patients, with a significant impact on health~     care service utilization, it was decided to focus on offering Mind/Body services to this~     population first.~   "
131777|NCT01330407|"~     The investigators intend to conduct a comparative, monocentric prospective double-blind~     study with intra-subject randomization, to compare the results on wound healing of 2~     adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and~     cryopreserved skin allografts.~   "
131778|NCT01330394|"~     Alcohol dependency is the most frequent addiction leading to a massive burden of both,~     patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and~     thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal~     function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and~     continuation of dependent behaviour. The results of pilot studies demonstrate that~     activation of prefrontal cortices via non-invasive brain stimulation improves cognitive~     performance in healthy subjects, and diminishes dependency-related behaviour in patients.~     The investigators aim to develop a stimulation protocol suited to induce a clinically~     relevant improvement of prefrontal functions in patients suffering from alcohol dependency.~     Therefore, the investigators will develop stimulation protocols which are able to modulate~     prefrontal activation for a much longer time course than those currently available, and will~     explore if the induced physiological alterations translate to respective cognitive~     improvements and reduction of addictive behaviour.~   "
131779|NCT01330381|"~     To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional~     constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label~     comparator (PEG) controlled part will follow, to document safety and tolerability up to 24~     weeks.~   "
131780|NCT01330368|"~     The purpose of this study is to compare healthy children to children who have systemic lupus~     erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and~     vertebral compression fractures.~   "
131781|NCT01330355|"~     The objective of this study is to evaluate the safety and efficacy of Besivance~     (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution~     when administered three times daily (TID) for seven days to neonatal subjects who are 31~     days or younger on the day of randomization (Visit 1).~   "
131782|NCT01330342|"~     The study's chief objective is to observe the evolution of cellular (in terms of expression~     of transmembrane transporters and their transcriptional regulators) and viral resistance (in~     terms of development of mutations in the HIV genome that may confer resistance to future~     treatment for HIV) in HIV-infected patients with lymphoma.~   "
131783|NCT01330329|"~     The purpose of this study is to evaluate the effectiveness of a technology-based system (the~     Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40~     kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral~     weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of~     the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool~     consisting of an armband that measures energy expenditure, a digital display watch that~     provides real time physical activity and energy expenditure feedback, and access to a~     system website which allows individuals to track their food intake and set exercise and~     dietary goals. We will examine differences in physical activity, weight loss, and program~     adherence between groups.~   "
131784|NCT01330316|"~     The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks~     of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated~     Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been~     withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and~     1220.47 trials.~   "
131785|NCT01330303|"~     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,~     02 sequences, and 02 periods, in which the volunteers receive, in each period, the test~     formulation or the reference formulation, under fed conditions.~   "
131786|NCT01330290|"~     The study objective is to evaluate advantages and disadvantages of Neupro® versus oral~     anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease~     patients requiring caregiver support in nursing home or outpatient care settings.~   "
131787|NCT01330277|"~     Hunter Syndrome (mucopolysaccharidosis II [MPS II]) is a lysosomal storage disorder caused~     by reduction or absence of the iduronate-2-sulphatase enzyme has still the problem of the~     difficulties of a simple and reliable analysis for the primary diagnosis but also for the~     follow-up of the disease. Especially in the cases of female carriers which have been~     reported to have some symptoms of MPS II due to skewed X-inactivation makes the diagnosis~     complex. However, early diagnosis and treatment of disease complications with enzyme~     replacement therapy can improve quality of life.Therefore the primary aim of our project~     called BioHunt is the development of a new plasma biomarker for the early and sensitive~     diagnosis of the disease. The secondary aim is the testing for clinical robustness,~     specificity and long-term stability of the biomarker.Within the scope of the study the~     investigators would like to collect in the next 12 months from about 80 patient's plasma and~     in parallel a simple documentation of the clinical data.~   "
131788|NCT01330264|"~     The SIM City study seeks to explore for the variance in practice that is associated with~     nursing and medical care of patients with brain pressure (ICP) monitors. The underlying~     hypothesis is that there is not a consistent pattern of care throughout the U.S., rather,~     there is a wide range of practice patterns that are used to monitor and treat ICP.~   "
131789|NCT01330251|"~     This study will investigate the effects of gastric bypass surgery on type II diabetes. The~     study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients~     without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients~     having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples~     of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after~     surgery during gastroscopy. Meal test with incretin measurements, and feces and blood~     samplings are performed before and after surgery~      Hypotheses are:~        -  The pathogenesis of type II diabetes is linked to changes in the expression of~          intestinal endocrine cells~        -  The changes in the incretine excretion after the gastric bypass surgery partly explain~          the amelioration of type II diabetes~        -  The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the~          development of atherosclerosis~        -  The immunologic functions of the intestine are changed by the gastric bypass surgery~          attenuating systemic inflammation~        -  The gastric bypass surgery changes cholesterol and bile acid metabolism~        -  The gastric bypass surgery changes the fecal microbiota~      Primary end points are:~        -  Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum~        -  Changes in the incretine secretion studied with liquid meal test~        -  Changes in the oxidation of lipoproteins~        -  Changes in the immunologic markers in ventricle, duodenum and jejunum~        -  Changes in the amounts of phytosterols, cholesterol metabolites and bile acids~        -  Changes in fecal microbiota~   "
131790|NCT01330238|"~     Modic changes are associated with low back pain (LBP) both in clinical and general~     population-based samples. Type I changes are regarded as more likely to be painful than type~     II changes. Several studies suggest that type I changes are inflammatory in nature.~   "
131791|NCT01330199|"~     The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of~     mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal~     tissues. This will be accomplished by determining the pharmacokinetic disposition and dose~     proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and~     raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal~     tissue.~   "
131792|NCT01330186|"~     The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET~     (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic~     Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging~     (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy~     (Cisplatin and 5-FU).~   "
131793|NCT01330173|"~     This phase I trial studies how well vismodegib after stem cell transplant works in treating~     patients with high-risk first remission or relapsed multiple myeloma. Vismodegib may slow~     the growth of cancer cells. Giving vismodegib after autologous stem cell transplant may kill~     more multiple myeloma cells.~   "
131794|NCT01330160|"~     If the risk of dementia occurrence after stroke is well known, few data exist about the~     factors influencing positively or negatively the developement of cognitive disorders or~     dementia. The aim of the study is so to determine prospectively the clinical, biological,~     lesional and pharmacological factors associated with post-stroke dementia by the long-term~     follow-up of a stroke patient cohort.~   "
131795|NCT01330147|"~     The principal aim of this study is to provide vital current data on the prevalence,~     distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This~     data is an essential requirement for the assessment, development and evaluation of cost~     effectiveness of prophylactic vaccination and screening programmes.~   "
131796|NCT01330134|"~     The objective of our study is to determine if technique of lidocaine administration can~     decrease pain perception.~      Hypothesis: There will be a significant difference in pain perception between patients who~     are given lidocaine on the skin surface prior to subcutaneous injection and patients who are~     given only subcutaneous injection by standard approach.~   "
131797|NCT01330121|"~     The purpose of the study is to evaluate patient adherence with discharge diabetes~     medications up to 120 days following pharmacist counseling during hospital stay about~     diabetes self management~   "
131798|NCT01330108|"~     The primary objective of this study is to assess the safety and tolerance of changing~     patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial~     hypertension.~   "
131799|NCT01330095|"~     To evaluate the effects of early administration of probiotics on acceleration of enteral~     feeding, and on growth of very low birth weight infants, newborn infants with birth weight~     less than 1500g are administered Bifidobacterium bifidum twice a day.~   "
131800|NCT01330082|"~     The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the~     adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source~     in the treatment of chronic periodontitis.~   "
131801|NCT01330056|"~     This is a prospective randomized controlled trial comparing functional organ preservation~     surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for~     patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and~     hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to~     preserve the organ function without compromising oncologic safety and survival.~   "
131802|NCT01330043|"~     Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and~     Santa Clara counties will serve as the target population for this study. A total of 400~     smokers meeting eligibility criteria will be randomized. Treatment will include both open~     label and extended treatment phases. Randomization. Participants will be randomized to~     extended therapy or control conditions at baseline (prior to open label treatment) and the~     analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary~     hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher~     prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the~     Supportive therapy Control treatment.~   "
131803|NCT01330030|"~     Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of~     this study is examine whether selegiline, given in the form of a skin patch, is effective in~     stopping smoking.~   "
131804|NCT01330017|"~     The trial will evaluate the nasal congestion symptom relief of the approved 10 mg~     phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with~     placebo in participants with histories of seasonal allergic rhinitis, using loratadine as~     background medication.~   "
131805|NCT01330004|"~     Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal~     disease) population. In dialysis patients, however, it has been shown that higher blood~     pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure~     evolution over time has not been previously studied in dialysis population. The~     investigators aim to understand how both blood pressure levels and blood pressure changes~     over time predict patient survival.~   "
131806|NCT01329991|"~     PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2.~     how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the~     safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate~   "
131807|NCT01329978|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir~     (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin~     (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.~   "
131808|NCT01329965|"~     The purpose of this study is to establish the safety and feasibility of low dose LPS~     administration to a small subset of humans in preparation for a larger USDA funded study~     examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day~     delivered as fish oil supplements) that significantly attenuates the inflammatory response~     the investigators wish to examine the effects of an endotoxemia model for inducing~     inflammation. Based on previous research, low dose LPS administration affects metabolism in~     humans with only minimal clinical effects (such as flu like illness). Therefore, each of~     the six subjects included in this small pilot study will receive a low dose of LPS and~     placebo in order to learn more about the metabolic changes that occur during administration~     and inflammation. The investigators hypothesis that LPS administration will elicit only~     minimal clinical effects (such as flu like illness) when compared to placebo~     (saline--water with the same amount of salt as in your blood).~   "
131809|NCT01329952|"~     The investigators will identify possible participants using our database of previously~     treated hepatitis c patients. The investigators will identify those who have documented~     evidence of current injecting drug use as a risk factor for acquisition of the virus. The~     investigators will then search for those who have received curative treatment between~     2004-2010. This covers all patients in the current database. The investigators will include~     those over 18 years old. The investigators will exclude those patients who are coinfected~     with either hepatitis B or HIV. This is because both of these conditions can accelerate~     liver damage when in combination with hepatitis c.~      The possible participants identified will be sent an information sheet giving a simple and~     clear outline of the proposed research. The investigator will try to obtain an au to date~     residential address from the PAS system in the NHS or through confirmation from the patients~     GP or drug worker. It will explain the purpose of the study, why they have been chosen, what~     taking part will involve, the potential advantages and disadvantages of taking part and that~     everything will be kept confidential. It will also outline who is conducting the study, how~     any expenses will be paid and contact details for any problems/complaints that arise.~      Those interested in taking part will attend an appointment at the hospital after they have~     had the opportunity to read through the information leaflet. They will be given time to ask~     any questions they have about the study and have them answered fully. They will then be~     asked to sign two copies of a consent form in order to take their participation any further.~     Once this is complete they can have their first 'liver assessment'. The assessment will take~     approximately 30-45 minutes to complete.~      The investigators will take three blood samples from them (approximately 10mls of blood or 4~     teaspoons full). One sample is to measure the levels of hepatitis C virus in the blood. This~     will tell us whether there has been reinfection with hepatitis C. The second sample is to~     measure the levels of inflammation within the liver and the third sample is to measure the~     full blood count. The investigators will then perform a liver scan called a fibroscan. This~     is a noninvasive test similar to an ultrasound (that pregnant women have) and gives a~     reading that can tell us about any 'stiffness' in the liver. It takes approximately five to~     ten minutes to complete and involves the patient lying on their back with their right arm~     above their head for the duration of the scan. Following the scan the investigators will ask~     the participant to complete a short questionnaire. This will include questions about past~     and current drug use as well as any alcohol use. The answers will be kept strictly~     confidential. They will be stored in the researchers locked office and have no direct~     participant identifiers on them. They will simply have a study number on them.The~     participant will then be thanked for their time and offered £30 to cover all travel and time~     expenses for their visit.~      They will be invited to attend for a further liver assessment one year after their first one~     and annually thereafter. This is optional and they are of course free to withdraw from the~     study at any time without needing to give a reason.~      The investigators will be identifying participants at different points in time following~     their curative treatment. For example some will have been cured 5 year ago whereas other~     will have been cured 6-12 months ago. This will increase the number of patient years follow~     up. Once the investigators have done the first set of liver assessment the participants will~     then be followed prospectively for as long as they wish to participate.~      For the purpose of my higher degree I will present the data I have following two years of~     'liver assessments'.~   "
131810|NCT01329939|"~     Background: In recent years, the prevalence of both asthma and obesity has risen~     dramatically among children and adolescents in the United States. Given the concurrent rise~     in the two epidemics, there may be an underlying link. Obesity contributes to asthma~     severity and control, and may play a role in its underlying cause. Obesity is associated~     with a state of heightened inflammation that may lead to an increase asthma symptoms and~     severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed~     to have better asthma control than those treated with other standard asthma medications. The~     use of montelukast in obese children and adolescents has not been specifically studied.~      Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and~     objective markers of asthma to a greater degree in obese, as opposed to non-obese children~     and adolescents. The investigators would like to determine if the use of montelukast will~     improve objective asthma scores, pulmonary function, markers of inflammation and medication~     use to a greater degree in obese as opposed to non-obese children/adolescents.~      Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a~     tailored approach focused on obese asthmatic children may help reduce the burden of this~     disease, health care costs and potential long-term complications as these children enter~     adulthood. Furthermore, this study may help clarify the underlying mechanisms that link~     asthma and obesity. Although this proposal is focused on one medication, it provides an~     example of how certain medications may have differential efficacy in the obese asthmatic.~   "
131811|NCT01329926|"~     The aim of this study is to develop and optimize methods to isolate, propagate and~     differentiate adult human neural stem cells from patients with degenerative neurological~     disorders like Parkinson's disease.~   "
131812|NCT01329913|"~     This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in~     HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected~     participants who will be randomized to receive either MK-6325 or placebo. If the drug is~     shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected~     participants who will be randomized to receive either MK-6325 or placebo.~   "
131813|NCT01329900|"~     The goal of this clinical research study is to learn if it is possible to collect stem cells~     after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects,~     number of stem cells collected, and the number of procedures that are needed to collect~     enough stem cells.~   "
131814|NCT01329887|"~     This study is an evaluation of the effect of ketanserine on sublingual microcirculation in~     intensive care patients with severe sepsis.~   "
131815|NCT01329874|"~     The purpose of this study is to determine whether Gow Gates block injection is more~     effective than conventional alveolar nerve block in anesthetising mandibular molars with~     acute pulpitis.~   "
131816|NCT01329861|"~     The aim of this study was to investigate whether an Internet-based cognitive behavioural~     intervention would have an effect on the symptoms of chronic back pain.~   "
131817|NCT01329848|"~     This project will develop clinically useful, objective measurements of accommodative~     insufficiency and fatigue using continuous autorefraction recordings. The development of~     these procedures will help vision care professionals diagnose and treat accommodative~     anomalies.~   "
131818|NCT01329835|"~     Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong~     association with pregnancy and birth complications for both the mother and her child. Most~     consequently reported maternal risks include an increased risk for gestational diabetes,~     hypertension and pre-eclampsia, increased incidence of induction of labour, operative~     delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and~     thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart~     defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more~     complicated in obese women than in normal weight women. Also in later life chronic diseases~     can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines~     suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese~     women in order to minimize the synergetic negative health consequences of excessive weight~     gain for both the obese mother and her child. Preventing excessive weight gain during~     pregnancy and postpartum weight retention is also important in the prevention of overweight~     and obesity among women of reproductive age. Obese women in general have a poor diet quality~     and are more exposed to psychosocial factors like anxiety and feelings of depression than~     normal weight women.~      The aim of this project is to perform a randomized controlled trial (RCT) in order to~     evaluate the effects of life-style intervention (psycho-education by a midwife during 4~     prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational~     weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing~     an adequate gestational weight gain with attention to psycho-social factors, can reduce the~     need for adverse perinatal outcomes.~   "
133492|NCT01307644|"~     This project will evaluate an Internet delivery strategy to address weight loss and~     maintenance among rural midlife and older women.~   "
131819|NCT01329822|"~     The aim of this randomized controlled study was to evaluate the effects of CR on circulating~     fetuin-A levels in obese humans with type 2 diabetes based on monitoring energy intake and~     energy expenditure by daily activity. Furthermore, the investigators examined the~     relationship between the changes of fetuin-A levels induced by CR and cardiovascular risk~     parameters including atherogenic lipid profile, visceral fat area (VFA), brachial artery~     endothelial function, and carotid IMT.~   "
131820|NCT01329809|"~     This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal~     carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in~     their liver.~   "
131821|NCT01329796|"~     Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An~     altered immune system with elevated levels of cytokines in the peritoneal fluid as well as~     increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in~     endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on~     nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent~     an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects~     related to hormonal treatments. A double blind randomized clinical trial, was carried out to~     evaluate pertubation with lignocaine as a therapy for dysmenorrhea.~   "
131822|NCT01329783|"~     Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the~     maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral~     Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort.~     The rates of specific clinical adverse events in this identified patient population will be~     compared with the rates of these events in the participants of the MOTIVATE trials.~   "
131823|NCT01329770|"~     The Fragile X syndrome (FXS) was first described by Dr. Martin and Dr. Bell in 1943, in~     families with several patients affected by sex-linked mental disability. This disorder is~     the most common cause of inherited mental disability. The prevalence of the Fragile X~     syndrome has been established at 1 in 2,500 males and 1 in 4000 females.~      Despite moderate to severe mental retardation, fragile X patients exhibit macroorchidism, an~     elongated face, long ears, connective tissue dysplasia, hyperactivity, autistic-like and~     stereotypical behaviours, speech delay and increased sensory sensitivity.~      Objective: To evaluate the effect of the combination of the antioxidant Ascorbic acid and~     tocopherol, as therapy of the Fragile X Syndrome in young males.~      Hypothesis: It is proposed that part of the pathophysiology of the central nervous system in~     the animal model of the fragile X syndrome may be determined by oxidative stress. In~     addition, Fragile X patients showed a significantly low level of ascorbic acid in plasma.~     The biochemical characteristics of oxidative stress may be reversed in the FMR1-KO mice, by~     a chronic treatment with antioxidant compounds such as tocopherol or melatonin, it may also~     normalize several hallmarks of the Syndrome such as hyperactivity, anxiety and cognitive~     deficits. The normalization of the oxidative stress is proposed as a new therapeutic pathway~     to alleviate conditions caused by an excess of free radicals that are crucial in~     neurodevelopmental diseases such as autism, down syndrome and other diseases of the central~     nervous system.~   "
131824|NCT01329757|"~     Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses~     of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first~     six months the pharmacological treatment will be associated to rehabilitation treatment.~      The main hypothesis is that GH can improve motor function of patients with traumatic spinal~     cord injury below the lesion level. The hypothesis is based on possible effects of GH at~     muscle and synaptic level. GH can also promote axonal growth and regeneration.~      Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation~     by third parties and blinding in the analysis of data (triple-blind design).~      Duration of intervention and monitoring: 364 days.~      Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale~     (motor score)~   "
131825|NCT01329744|"~     This study examines the effects of recombinant insulin like growth factor - I on body~     composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of~     metabolic disease.~   "
131826|NCT01329731|"~     The aim of this study is to monitor the effect of intraoral topical high fluoride~     application on the development of white spot lesions (WSL) after orthodontic treatment with~     multibracket appliances and to compare it to a placebo.~   "
131827|NCT01329718|"~     Epigenomics has identified methylated gene regions that are specific for colorectal cancer~     (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified~     as a particularly robust methylation marker for detection of CRC. Epigenomics is currently~     developing a blood based CRC screening test based on Septin 9 and is performing a large~     prospective clinical trial showing its clinical utility in a population at average risk for~     CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop~     pre-analytical and analytical workflows as well as molecular assays making possible the use~     of Septin 9 methylation in the clinical routine.~   "
131828|NCT01329705|"~     The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX)~     injections (tone management) and dynamic splinting (contracture reduction) for improving~     gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury~     and resultant excessive plantarflexion.~   "
131838|NCT01329575|"~     There is no single method to investigate mediastinal LN invasion. Hence, a patient may have~     to undergo several tests and procedures. Noninvasive and invasive approaches are employed.~     Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA)~     and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are~     gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit~     needle aspiration under direct vision for cytology specimen analysis. As more evidence is~     being accumulated on these staging approaches, the number of cervical mediastinoscopies,~     considered as the gold-standard for mediastinal staging, is diminishing.~      Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a~     small number of studies and needs to be further investigated.13,14 With the good results~     obtained with superficial US, it seems reasonable to believe that color Doppler~     characteristics would increase accuracy in detecting malignancy of mediastinal LNs with~     endoluminal US.~   "
134922|NCT01288898|"~     This study determined the safety of ASP1941 after a single and multiple once-daily doses for~     10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics~     (PD) of ASP1941 were assessed.~   "
131829|NCT01329692|"~     Purpose and objective: To identify in the early post-operative period following laparoscopic~     Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected~     fashion, and to institute intervention and assess for its efficacy.~      Study activities and population group: Patients identified to have poor weight loss (≤ 11%~     of excess weight loss) at 1 month will be randomized into a control versus study group.~     Intervention for subjects randomized to the IV arm will be by enrollment in the Back on~     Track program. This is a seven-week group education, counseling, nutrition, exercise, and~     journaling program of the Duke Weight Loss Surgery Center designed to help postoperative~     bariatric surgery patients who are failing to progressively lose weight resume an expected~     pattern of weight loss and improved overall outcome.~      Data analysis and risk/safety: Data will be collected and analyzed by the identified~     investigators. The goal of data analysis is to uncover any difference in the EWL of subjects~     who underwent intervention for falling in the lowest EWL quartile when compared with those~     who did not undergo intervention, and determine the statistical significance of any such~     difference. There are no physical risks associated with this study. There is, however, the~     potential risk of loss of confidentiality. Every effort will be made to keep your~     information confidential.~   "
131830|NCT01329679|"~     Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart~     rhythm in healthy subjects.~      Study design: Double blind, placebo controlled, cross-over~      Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no~     other medical conditions.~      Intervention: 5 Hour Energy or Placebo~      Primary outcome: Change in office systolic blood pressure~   "
131831|NCT01329666|"~     Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people~     every year. In the presence of this condition, the parathyroid glands produce excessive~     amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of~     parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium~     in the blood, which is then filtered into the urine by the kidneys. Bone health is~     threatened by excess calcium loss which weakens bone structure. Other affected organs~     include the skeleton (calcium loss leads to a weakening of the skeleton), and the kidneys~     (high blood calcium can lead to kidney stones).~      It is now evident that the majority of patients with even mild Primary Hyperparathyroidism~     are vitamin D deficient. In 2009, new international guidelines for the management of~     asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all~     patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml).~     However, no recommendations for vitamin D repletion are given, because of limited data~     regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore,~     there is an urgent need for data upon which to base such recommendations, as well as are~     data on the effects of such treatment upon bones.~      Subjects with low vitamin D3 levels will be selected for this trial. They will be given~     enough vitamin D3 to raise their low blood levels from a low to a normal range. The~     assessments in this study, including the quadruple label bone biopsy, will allow us to~     document the short term effects of administering vitamin D3 on changes in bone.~      All participants enrolled in this trial will be vitamin D3 deficient. Participants will take~     an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone~     changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or~     placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin~     D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course~     of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small~     piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac~     crest). The bone will be analyzed to determine the effect of vitamin D3 on primary~     hyperparathyroidism.~      There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy~     will be performed.~      Study Procedures:~      Medical and Social History~      Blood tests (drawn at the study center and local Quest Lab)~      24-Hour urine collection for calcium and creatinine excretion~      Abdominal X-ray (to assess for kidney stones)~      Transiliac crest Bone Biopsy~   "
131832|NCT01329653|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads increased~     cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older~     adults.~   "
131833|NCT01329640|"~     The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of~     metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally~     advanced HER2-positive breast cancer.~   "
131834|NCT01329627|"~     The purpose of this study is to determine whether weekly paclitaxel followed by weekly~     doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor~     (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.~   "
131835|NCT01329614|"~     The purpose of this study is to determine whether Cue Extinction Training will reduce~     relapse rates in cigarette smokers using the patch to quit.~   "
131836|NCT01329601|"~     The study aims to detect the effect of a structured cognitive rehabilitation program, teh~     stage specific intervention STACog, on cognitive performance and functional activation in~     fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's~     disease compared to a waiting group control sample. Baseline performance in cognitive tests~     and fMRI will further be assessed compared to healthy control subjects.~   "
131837|NCT01329588|"~     In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified~     as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of~     other sexually transmitted infections (STIs) facilitated transmission of the virus to their~     clients, who then infected low-risk women not involved in the sex trade. In resource-poor~     settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is~     difficult. The purpose of this study is to determine whether periodical antibiotic treatment~     (PAT) is effective in controlling these infections among West African FSWs.~      The study is designed as a cluster-randomized double-blind placebo-controlled trial~     conducted in West Africa. The study population consists of seaters FSWs who work from~     their homes in well-defined areas. Clusters will be paired according to their size and~     demographic characteristics of FSWs and clients. Within each pair, one cluster will be~     randomly allocated to the intervention and the other to the placebo group.~      At enrollment, participants will be interviewed, a pelvic examination performed, cervical~     swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or~     vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All~     participants will be given free condoms and counseled on risk reduction.~      Monthly follow-up will be conducted within FSW communities, alternating with clinic visits~     where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin~     500 mg, and their identical placebos) will be distributed every month according to a~     predefined schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and~     ciprofloxacin at months 2, 3, 5, 6, 8 and 9.~      Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT~     prevalence separately in both study groups using χ2-for-trend.~   "
131839|NCT01329562|"~     The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following~     treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide~     (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase,~     Prostaglandin E2 (PGE2), Prostaglandin I2 (PGI2) and beta (ß)-endorphin in saliva before and~     after Treximet™, (3) evaluate efficacy of Treximet™ to return to baseline levels following~     treatment, and (4) correlate estrogen in saliva vs. urinary estradiol at mid-luteal, onset~     of menstrually-related migraine, and after successful treatment with Treximet™.~   "
131840|NCT01329549|"~     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to~     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in~     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma~     or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with~     carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease~     progression is observed.~   "
131841|NCT01329536|"~     The purpose of this clinical research study is to determine if a specific genetic allele is~     involved with the development of agitation in patients with late-onset Alzheimer's Disease~     (AD). The study will compare the results of genetic testing between two groups: individuals~     with late-onset AD who show signs of agitation and individuals with late-onset AD who do not~     show signs of agitation.~   "
131842|NCT01329523|"~     The purpose of this study is to determine if insulin-like growth factors (IGF) play a role~     in the development of dementia, specifically Alzheimer's disease (AD). The study will~     compare results from genetic testing between patients with AD and two other groups: younger~     biological family members of the AD patients and individuals without AD matched by age to~     the AD patients.~   "
131843|NCT01329510|"~     This study will investigate the effects of methylphenidate on sleep in adults with Attention~     Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.~   "
131844|NCT01329497|"~     Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor~     for all-cause and cardiovascular mortality in these patients. Effective treatments are~     limited in suppressing plasma phosphorous. Because of the nearly linear relationship between~     protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended~     by KDOQI) would load high phosphorus burden in PD patients. It is suggested that~     hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take~     sufficient phosphorus blinders and receive high PD dosage. The present study is to~     investigate whether systemic dietary instruction would show effects on control of~     hyperphosphatemia in PD patients.~   "
131845|NCT01329484|"~     The purpose of this study is to determine whether the use of computerized systems in 2~     common non pharmacological therapies (cognitive training and reminiscence therapy) will~     improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD),~     or at least delay its deterioration. In addition, the investigators hypothesize that using~     the computerized systems will result in improved well-being of the patients and their main~     caregivers / family members, and in improved patient-caregiver and patient-family relations.~   "
131846|NCT01329471|"~     The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML),~     in particular, the transcriptional regulation of genes by mutated forms of this protein.~     This research will study the effect of mutations found in AML patients~   "
131847|NCT01329458|"~     The aim of the study is to assess the value of contrast enhanced ultrasound in the~     evaluation of de novo focal liver lesions in clinical practice, in a prospective~     multi-center design.~   "
131848|NCT01329445|"~     The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue~     product used for the repair of cartilage damage in the knee. This product has been on the~     market since 2007 and implanted in more than 10,000 patients around the country.~   "
131849|NCT01329432|"~     Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is~     thought to have some advantages compared with mechanical ventilation in premature infants.~     In addition, early surfactant administration has been shown to be superior to delayed use.~     The aim of this pilot study was to describe the feasibility of TAKE CARE (early~     administration of surfactant in spontaneous breathing) procedure and compare its short-term~     and long-term results with InSurE procedure.~   "
131850|NCT01329419|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according~     to the prescribing information~   "
131851|NCT01329406|"~     The present study will aim to evaluate the efficacy of milnacipran in the treatment of pain~     due to osteoarthritis (OA), that is, to determine whether milnacipran provides superior~     efficacy to placebo in patients with OA. Milnacipran is a serotonin-norepinephrine reuptake~     inhibitor (SNRI) that is currently approved in the United States in the treatment of major~     depressive disorder and fibromyalgia. There is increased evidence to suggest that SNRIs may~     be effective in the treatment of chronic pain conditions, such as OA.~      The hypothesis in this study is that the survival time (time from randomization to loss of~     efficacy) of milnacipran group is superior to that of placebo group.~   "
131852|NCT01329393|"~     This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and~     collect qualitative data concerning a brief money management intervention for people~     disabled by psychiatric illnesses.~   "
131853|NCT01329380|"~     This study of Humira will be conducted to clarify the following with regard to the treatment~     of ankylosing spondylitis with this drug:~        -  Unknown adverse drug reactions (especially important adverse drug reactions)~        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting~        -  Factors that may affect the safety and effectiveness of Humira~   "
131854|NCT01329367|"~     The consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and~     vegetables) could have beneficial effects beyond those of the caloric restriction on~     biomarkers of the inflammatory and oxidative status. OBJECTIVE: To address the effect of a~     10-week dietary intervention aimed to weight loss in obese or overweight children (7-15~     aged) on genomics, particularly the changes in the expression of genes related to the~     inflammatory status and oxidative stress. METHODOLOGY: 44 Navarra children and adolescents~     of both sexes from Pediatric Endocrinology Services at different Hospitals in Pamplona will~     be recruited. The effect of the intensive consumption of different groups of food will be~     evaluated: legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in~     antioxidants). Before and after the intervention, the following items will be analyzed: (1)~     the diet of the subjects, (2) body composition and 3 magnitudes related to biological and~     development parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of~     the inflammatory status and oxidative stress, and (5) the genomic profile. The dietary~     programme will be implemented both in group workshops addresseded to patients and their~     family, and in individual sessions with the pediatricians and/or registered dieticians.~     Finally, the programme efficacy will be evaluated by the scoreboards integrated in the 5~     variables already mentioned.~   "
131855|NCT01329354|"~     Nowadays, therapy with monoclonal antibodies is considered to be a standard treatment that~     increases the rate of remissions and the overall survival in patients with follicular~     lymphoma. Nevertheless there are an important number of patients who do not benefit from~     this therapy. A way to improve the efficiency of monoclonal antibodies therapy could be to~     improve the activity of the effector arm of the immune system. A strategy that has been~     proposed to obtain this improvement is the utilization of lymphocyte activated killer (LAK)~     cells. In addition, the combination of LAK cells with monoclonal antibodies might obtain an~     additive effect across the stimulation of the antibody dependent cellular cytotoxicity~     (ADCC)activity.~      The present clinical assay proposes to study the feasibility, safety and effectiveness of~     treatment with autologous effector cells expanded ex vivo associated with a standard~     maintenance treatment with rituximab in patients with follicular lymphoma in remission after~     first-line treatment. In addition, we plan to analyse various biological parameters that can~     predict the susceptibility of patients to treatment with rituximab. Specifically, we propose~     to study the polymorphisms of Fc receptor, polymorphisms related to the ability of~     complement activation, to study both the complement activity and peripheral blood cell~     subpopulations that can mediate directly or indirectly dependent antibody cytotoxic effect.~     We will also try to correlate any of these biological parameters with the response to~     treatment.~   "
131856|NCT01329341|"~     The purpose of this study is to evaluate use of service dogs for individuals who have been~     diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the~     impact service dogs have on the mental health and quality of life of Veterans; (2) to~     provide recommendations to the VA to serve as guidance in providing service dogs to~     Veterans; and (3) To determine cost associated with total health care utilization and mental~     health care utilization among Veterans with PTSD.~   "
131857|NCT01329328|"~     The aim of this study is to evaluate the effect of whole-body vibration in the presence or~     absence of localized radiofrequency on body composition in obese female subjects. Moreover,~     balance and strength tests will be performed. The study hypothesis is that whole-body~     vibration induces positive changes in body composition i.e., reduction of fat mass and~     increase of lean mass with associated increase in performance. The possible additive role of~     radiofrequency will also be assessed.~   "
131858|NCT01329315|"~     This study examines the impact of tailored computer-delivered and therapist-delivered brief~     motivations prevention/interventions both for adolescents who have not initiated marijuana~     use (prevention), and those who use marijuana (intervention). Key moderators of~     prevention/intervention effectiveness will be examined, including behavioral intentions,~     self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and~     potential health consequences such as STD/HIV risk behaviors. This project will provide the~     critical first step toward the development and implementation of marijuana use~     prevention/intervention programs that have the potential to be delivered to a large segment~     of youth who seek care in our nation's primary care settings.~   "
131859|NCT01329302|"~     The object of this study is to determine the benefit of follicular flushing with a double~     channel needle in a poor responder population for a maximum number of oocytes to be~     retrieved. The investigators compare two methods of oocyte retrieval with or without~     flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm~     Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and~     more the day of ovulation induction will be included, following a randomized protocol in two~     groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G.~     Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all~     follicles are flushed with flushing solution in addition to direct aspiration of the~     follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing~     medium is collected separately from direct fluid aspiration in order to follow up each~     oocyte one by one. First criterion of our comparison is the number of oocyte retrieved.~     Second criteria are: oocyte quality, fertilization rate, number and quality of embryos~     obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups:~     oocytes collected in flush medium and oocytes from direct follicle fluid. Then the~     investigators will know the capability of oocyte collected after follicular flushing to be~     fertilized and to increase the success chance of pregnancy for poor responder patients.~   "
131860|NCT01329289|"~     The purpose of this study is to determine if adding SOM230 LAR to bortezomib and~     dexamethasone is better than bortezomib and dexamethasone alone and if it should be~     investigated further.~   "
131861|NCT01329276|"~     Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very~     sensitive to detect small changes, it might be worthwhile to study the acute effect of~     formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper~     airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this~     technique makes it possible to detect changes in airway caliber in early stages. The~     regional distribution of resistance and the change in this parameter will provide more~     insight into the mode of action of the product.~   "
131862|NCT01329263|"~     This study will examine how menthol affects smoking when menthol smokers switch to~     non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel~     Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given~     Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days~     each. Participants will provide breath and urine samples, track cigarette usage and complete~     smoking topography assessments of smoking behavior.~   "
131863|NCT01329250|"~     The main objective of this prospective clinical trial is to compare pharmacokinetics and~     safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg)~     of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX~     in a higher dosage in TB patients.~   "
131864|NCT01329237|"~     The purpose of the study is to compare strut coverage and neointimal thickness between~     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14~     months after stent implantation and to determine the coronary endothelial function after~     everolimus eluting (XIENCE-V® or PROMUS® stent) and biolimus A9 eluting NOBORI Stent 14~     months after stent implantation by using supine bicycle exercise testing to assess coronary~     vasomotor response to exercise.~   "
131866|NCT01329211|"~     The project will involve conducting a Needs Assessment for Gastroparesis patients and their~     caregivers with the goal of identifying quality of life issues associated with this disease.~     Identifying these issues will ameliorate management and support systems for gastroparesis~     currently existent in the community and, hopefully, provide information for the~     establishment of more resources to assist the patients and their families.~   "
131867|NCT01329198|"~     The purpose of this trial is to determine whether a particular type of Deep Brain~     Stimulation (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe~     treatment for Tourettte syndrome (TS).~      The trial will also examine the brain activity associated with TS and tics and explore the~     possibility of responsive brain stimulation (RBS).~   "
131868|NCT01329185|"~     The aim of our study is to reduce viral (CMV and EBV) transmission from donor to recipient.~     The discovery that anti-retroviral therapy to mothers with HIV reduced transmission of the~     virus to their babies was pivotal to the prevention of AIDS and so along the same lines the~     investigators will test the hypothesis that 14 days of the anti-viral Valganciclovir (VAL)~     to kidney donors prior to the transplant compared to placebo will reduce EBV and CMV viremia~     in the 1st year posttransplant in pediatric kidney recipients.~   "
131869|NCT01329172|"~     Background :~      Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different~     secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have~     been shown to influence survival and MUC5B expression in mice model of chronic pulmonary~     infection.~      Method :~      To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in~     airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1,~     MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by~     nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a~     double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day)~     vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary~     study end point will be assessed two times: before randomization and after 60 days of~     treatment.~      Statistical analysis :~      Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and~     per protocol.~   "
131870|NCT01329159|"~     The aim of this study is to assess in the sample of population resident in the KHUMBU valley~     (NEPAL):~        1. the respiratory function decline by means of spirometry and the respiratory health by~          means of questionnaire and six-minute walking distance~        2. the presence of markers of early atherosclerosis with ultrasound and to estimate the~          value of systolic pulmonary pressure in comparison with not exposed subjects.~      The investigators hypothesize that the chronic exposure to indoor pollution~        1. can accelerate the physiological respiratory function decline, usually around~          15-20mL/year in healthy subjects~        2. induce cardiovascular impairment~           The population of high altitude villages is a unique sample to study the effect of the~          only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and~          the very low level of smoking habits allow to have no other confounding factors~        3. to study and analyze how the architectural features of the buildings of the village~          (distribution of domestic locals, natural or non natural ventilation systems, domestic~          activities, materials used, etc.) affect the indoor pollution from carbon monoxide,~          which necessarily is developed indoor during the daily life activities.~      What the project prospects is to gather information focused on the scale of the building,~     independently from the typology, to study a model that will help to describe which aspects~     are most important to what concern the genesis of the pollution of the indoor air.~   "
131871|NCT01329146|"~     Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to~     be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV~     measurement has not been yet validated in thoracic surgery during one-lung ventilation. The~     modifications of intrathoracic pressure induced by one-lung ventilation may altered the~     capabilities of PPV to predict fluid responsiveness.This study was designed to assess the~     ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.~      Methods: a prospective observational study. Thirty five patients undergoing a pulmonary~     resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid~     challenges with a 250 milliliters colloid solution in response to hemodynamic~     instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from~     baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined~     as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV~     will be calculated from recorded artery pressure curve (PPVref) before and after each fluid~     challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will~     be recorded simultaneously before and after each fluid challenge.~      Statistical analysis: receiver operating characteristic curve will be used to assess the PPV~     capability to predict fluid responsiveness. Correlation analysis will be achieved using a~     Pearson test or Spearman's rho test when necessary. Continuous data will compared using a~     Student t test or a Mann-Whitney test when necessary.~   "
131872|NCT01329133|"~     Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is~     classically treated by antidepressant medications in combination with psychotherapies.~     However, both these conventional therapeutic approaches fail to sufficiently improve~     obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain~     stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been~     introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts~     on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists~     of the delivery of a high-frequency current through the quadripolar electrodes connected to~     a battery powered pulse-generating device. Several clinical investigations have shown that~     DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN),~     as brain sites of interest because of their particular involvement in the production of OCD~     symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom~     intensity in severely chronic and incapacitating forms of OCD. These promising findings lead~     to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the~     VS or STN as brain target by conducting a large controlled trial and including a~     medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the~     present study is expected to promote and highlight the importance of DBS, as an effective,~     safe, well-tolerated and cost-relevant surgical approach for the management of resistant~     OCD.~   "
131873|NCT01329120|"~     A large number of institutions have reported their early results with minimally invasive~     repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed~     the outcomes relevant to the concerns of the patients and even fewer have reported long-term~     results following bar removal. Even fewer studies have investigated the prevalence and~     characteristics of long term persistent post-surgical pain following surgical repair of~     pectus deformities. The reasons as to why acute postoperative pain in some patients persists~     and becomes chronic whereas in others the pain dies down shortly after wound healing are~     largely unknown, and why some patients complain of loss of sensibility in wide regions of~     their chest following surgery also remains unclear.~   "
131874|NCT01329107|"~     The incidence of bladder cancer is increasing. Denmark have approximately 1800 incidence per~     year. The disease is most frequently in males above the age of 70 years. In invasive~     bladdercancer surgery including removal of the seak bladder with constructing of a new~     diversion, is the first line treatment. However the procedure is followed by a high~     morbidity and convalescence. Extended surgical procedure cause pain, stress-induced~     metabolism and impaired organ function resulting in postoperative complications impacting on~     rehabilitation. The combination of extended surgery and the increasing numbers of elderly~     comorbid patients with invasive bladder cancer challenge professional treatment and care~      The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation~     programme for patients with invasive bladder cancer referred to surgery~      Material and Methods The study is a randomised controlled trial. All patients > 18 years~     referred to radical cystectomy will be eligible for this study. The efficacy is primary~     expressed by the difference in length of stay(LOS). Secondly by complications, health~     related quality of life(HRQoL) and patient reported quality of care during hospitalization.~     The intervention includes precise instructions and educations in intensive pre- and~     postoperatively exercises and stoma-care, supported by the multiprofessional team.~      Perspective It is a national goal to improve cancer care. This study is of critical~     importance and places great emphasis on the patients perspective and involvement in a~     successful outcome for participant`s and involvement in nutritional support, intensive~     exercises and stoma care, supported by the multidisciplinary team~   "
131875|NCT01329094|"~     The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS)~     in relation to patients with severe mental illness. The study hypothesised that physical~     activity levels among patients with severe mental illness was significantly lower than~     healthy controls. The physical activity level of patients with severe mental illness~     attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched~     on gender and age was assessed with PAS.~   "
131876|NCT01329081|"~     BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in~     Denmark. The results after TKA is in general very good, the investigators have, however,~     discovered that patients following fast-track TKA still have a deficit 12 months~     postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and~     participation when compared to age- and gender matched population. A postoperative~     rehabilitation intervention has the potential to reduce or remove this observed deficit. The~     current evidence of postoperative rehabilitation after TKA is, however, scares and~     conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.~      PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative~     rehabilitation intervention is more effective than supervised home training, and furthermore~     to investigate the cost-effectiveness of the intervention in a societal perspective.~      MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140~     patients are included in the study. Inclusion criteria are age above 18 years, patients~     diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients~     who are able to and willing transport themselves to the rehabilitation center, which demands~     ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental~     or revision arthroplasty, any neurological disease, knee infection, and substantial pain or~     functional limitation hindering rehabilitation tested by physiotherapist prior to~     rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome~     measure is change in total score by using the knee specific questionnaire Oxford Knee Score.~   "
131877|NCT01329068|"~     Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in~     the course of their lives . They face a difficult choice: either a preventive removal of the~     breast(s) or an intensive inspection process.~      After primary treatment of breast cancer, patients will be followed for 5-10 years to~     diagnose recurrence or a new primary tumor in an early stage; to support the patient during~     hormonal treatment; to educate the patient about risk factors and healthy life style; and to~     provide psychosocial support.~      Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is~     offered in regular, one-to-one medical visits. Experience shows that in an individual visit~     it is often not possible to give all aspects that are important, enough attention. The group~     medical consultation (GMC) is a new form of medical visits where the physician or nurse~     practitioner performs a series of one-to-one consultations in the presence of 8 to10 other~     patients. A social worker accompanies this process. Patients in group consultations may~     gather more information because they learn from each other and there is relatively more time~     compared to a regular consultation. Research shows that both patients and caregivers are~     more satisfied with care after a group consultation compared to individual visits. After a~     GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for~     3 months. Using this iPad, patients can contact the women they have met during the GMC as~     well as health care professionals by several communication channels, including virtual group~     meetings. This approach provides a unique combination of both social support and~     professional education concerning survivorship in an e-health environment.However, it is~     also known that group sessions may be counterproductive for some patients, for example~     because they are frightened by the stories of others. The goal of this study is to examine~     whether group visits (in combination with dedicated iPads) are beneficial to women with a~     BRCA mutation and for patients in follow-up after breast cancer.~   "
131878|NCT01329055|"~     Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients~     undergo a certain consistent predictable pattern at the initiation of dialysis and before~     death. This pattern can be described as a group of patterns of patients' biological markers~     over a few months after starting dialysis and several months prior to death. Additional~     patterns can be observed that occur with changes in seasons or time of day. The aim of this~     study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South~     America, and RRI-US populations. Noting that patterns in patient parameters are similar~     across continents, climates, and geographic variations only further accentuates the~     importance in the models that can predict patients' survival and provide an opportunity for~     timely intervention.~   "
132269|NCT01323881|"~     This pilot sham-controlled study aims to determine the safety and efficacy of repetitive~     transcranial magnetic stimulation given as a facilitatory intermittent theta burst~     stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute~     stroke patients.~   "
131879|NCT01329042|"~     Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become~     the therapy of choice for renal stone. Although providing good results, stone recurrence is~     usually found as the therapies do not change the underlying metabolic abnormality. Among the~     metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis.~     This study evaluate the preventive effects of potassium sodium citrate on stone recurrence~     as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.~   "
131880|NCT01329029|"~     The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets~     once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who~     are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and~     inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of~     roflumilast will be obtained. An additional objective is to further characterize the~     population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further~     characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of~     efficacy and relevant safety aspects.~      Patients to be included are required to have severe COPD associated with chronic bronchitis~     and a history of frequent exacerbations and must be concomitantly treated with a fixed~     combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and~     placebo) are included.~   "
131881|NCT01329016|"~     This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and~     combination treatment for gestational diabetes mellitus.~   "
131882|NCT01329003|"~     Silicosis is well-known occupational disease caused by free crystalline silica (silicon~     dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative~     evidences that exposure to Caesar stone (quartz surface products that manufactured from up~     to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers.~      Goals: To examine correlation between disease and exposure to Caesar stone and genetic~     differences regarding genes involved in oxidative stress to understand Genetic~     susceptibility~   "
131883|NCT01328990|"~     The aim of the study is to determine the pharmacokinetic profile of~     sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for seasonal Intermittent~     Preventive Treatment (IPT) to prevent malaria in children aged 3 to 59 months in Lamarame,~     NDoffane District, Senegal. Several studies have shown that seasonal IPT in children can~     provide a high degree of protection against clinical malaria. SP+AQ is the most effective~     regimen. However little is known about the pharmacokinetics of amodiaquine and~     sulfadoxine-pyrimethamine in children. The purpose of this study is to determine the~     pharmacokinetics profile of SP+AQ when used for IPT in Senegalese children. 150 children~     aged 3 to 59 months will be enrolled in November. They will receive a therapeutic dose of~     sulfadoxine-pyrimethamine and amodiaquine, and will be followed up for 30 days. Four finger~     prick blood samples will be taken from each child for PK analysis.~   "
131884|NCT01328977|"~     This study attempted to identify the best method for educating and engaging academic~     physicians in grateful patient philanthropy.~   "
131885|NCT01328964|"~     The objective of this study is to compare asthma-related exacerbations (emergency department~     (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that~     received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast~     (MON). This retrospective observational cohort analysis utilizes a large managed care~     database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or~     BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index)~     with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously~     eligible to receive healthcare services for 1-year pre-index and at least 30 days~     post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was~     defined for each patient as the period beginning with the index date and ending with the~     last date of continuous claims history, switch to another asthma controller medication, or~     claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred~     first.~   "
131886|NCT01328951|"~     This double-blind, placebo-controlled study will evaluate the benefit of first-line~     maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in~     participants with advanced NSCLC who have not progressed following 4 cycles of platinum~     based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor~     (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150~     milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will~     receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on~     erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will~     continue until disease progression, death, or unacceptable toxicity. Participants may also~     be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.~   "
131887|NCT01328938|"~     This study is adaptive design and it consists of stage I and stage II.~      Stage I is multi-center, parallel-group, single-blind, phase II study to determine the~     adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will~     be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.~      Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the~     efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to~     Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate~     into this phase.~   "
131888|NCT01328925|"~     The purpose of this study is to determine the effectiveness of nitazoxanide suspension~     compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of~     age.~   "
131900|NCT01328756|"~     While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,~     safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and~     adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have~     been of short duration - up to 8 weeks.~      A number of long-term studies have been undertaken (up to 1 year) and these have confirmed~     the safety and ongoing efficacy in this patient population.~      In order to run a study with investigational medication within Poland the study changed to a~     Phase 3 rather than a Phase 4 study in that country. Please note that the study number~     remains as SPD489-404.~      Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in~     children and adolescents over a 2-year treatment period.~   "
131889|NCT01328912|"~     Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less~     vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a~     period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in~     several randomized studies in patients undergoing cardiac and vascular surgery, as well as~     interventional cardiac procedures such as angioplasty. They have shown improvements in~     cardiac, renal, neurologic and respiratory function. Most have focused on surrogate~     outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No~     trials have investigated only high-risk patients or been designed to detect clinical~     outcomes.~      This study is a randomized-controlled trial powered to detect clinical events in a high-risk~     cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to~     cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery)~     or control (no ischemic stimulus).~      The investigators hypothesize this population will demonstrate lower rates of adverse~     ischemic events. The investigators also intend to sample biochemical markers to better~     elucidate the mechanism of RIPC and generate hypotheses for future studies and~     interventions. Post-operatively the investigators will monitor for adverse clinical outcomes~     including cardiac, renal, pulmonary and neurologic injury.~      RIPC is simple, inexpensive and easily reproducible and there have been no reports of~     adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction,~     cardiac, renal and respiratory failure affect patient survival and quality of life, and~     represent a sizeable financial burden to health care. If beneficial effects of RIPC are~     demonstrated, it will be widely applicable to the entire population of cardiac and vascular~     patients resulting in a widely-implemented change in practice.~   "
131890|NCT01328899|"~     This is a multicenter single arm open label study. The primary objective is to evaluate the~     safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of~     patients with emphysema in multiple centers.~   "
131891|NCT01328886|"~     The purpose of this extension study is to assess the long-term safety and tolerability of~     omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with~     inadequately controlled allergic asthma despite current recommended treatment by providing~     continued treatment with omalizumab to patients who have previously completed the core~     study.~   "
131892|NCT01328873|"~     Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant~     (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate~     new pulmonary infiltrates in this population, however utility is limited by a historically~     low diagnostic yield for infection.~      In an effort to improve diagnostic yields, this study will complete a Fiberoptic~     Bronchoscopy (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates,~     prior to initiating new antibiotic therapy. To further improve detection of microbiological~     pathogens, the study will utilize PCR testing with rapid turnaround time to detect atypical~     pneumonia (M pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and~     aspergillosis.~   "
131893|NCT01328860|"~     The purpose of this research study is:~        1. To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal~          Cord Injury, and~        2. To determine if late functional outcome is improved following Bone Marrow Cell~          transplantation in children with Spinal Cord Injury, using pre-transplantation spinal~          cord function as the control.~   "
131894|NCT01328834|"~     This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).~   "
131895|NCT01328821|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     CTP-499 following single dose administration.~   "
131896|NCT01328808|"~     The purpose of this study is to investigate how acetaminophen (APAP) is released into the~     urine and blood; to determine how the blood levels of acetaminophen and its breakdown~     products affect the preterm infant's health; to decrease adverse drug reactions; and to~     collect data on how the genetic make-up or characteristics affect how APAP is handled within~     the preterm infant. By taking several blood and urine samples during the study, we will be~     able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.~   "
131897|NCT01328795|"~     Aims of the study:~      Patients in a Chest Pain Unit (CPU) are examined to clarify if the cause of pain is cardiac~     or not. To identify patients with ST-elevation and other electrocardiogram (ECG)~     modifications a normal 12-lead ECG is used. The diagnosis non-st-elevation myocardial~     infarction is determined with the help of the ischemic marker Troponin. However, Troponin~     levels are elevated earliest 3 to 4 hours after the ischemic event, so that a negative~     Troponin result at the time of hospital admission is insufficient. Thus the guidelines of~     the German Society of Cardiology demand a second measurement after 6 to 12 hours. In rare~     cases false positive Troponin levels have been reported (e.g. in patients with renal~     insufficiency).~      The aim of this study is to determine if in the early phase of diagnostic assessment~     cardiogoniometry can improve differentiation between patients with cardiac (ischemic)~     emergency and patients with non-cardiac (non-ischemic) cause of pain. Furthermore it will be~     evaluated if cardiogoniometry is capable to diagnose patients with non-ST-elevation~     myocardial infarction (NSTEMI) to the same extent as Troponin. This could avoid time loss~     until a possibly necessary catheter intervention (fast track).~      To clarify these questions the result of the cardiogoniometry will be compared with the~     leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as~     with the angiographic findings (as a gold standard). Therefore the performance of cardiac~     catheterization within 72 hours after start of symptoms is a mandatory inclusion criterion.~   "
131898|NCT01328782|"~     The goal of this study is to compare different ways of treating pain after surgery. This~     research study involves subjects who have a supracondylar elbow fracture and need surgery.~     This type of fracture occurs when the humerus (upper arm bone) is broken just above the~     elbow. Like any other surgery, you can expect that you will feel pain in the hours or days~     after the operation. Currently, despite the common occurrence of this surgery, there is not~     a standard way to treat and or prevent any of the pain afterwards.~      At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after~     this surgery.~      In this study, pain will be treated in one of the following ways:~        1. with oral pain medication~        2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of~          bupivacaine (a numbing drug) or~        3. with oral pain medicine and an intraarticular shot of ropivacaine (another numbing~          drug). The shots will be given during surgery. Your participation will help us find out~          which of these three pain control methods works the best.~      The correct dosages of all drugs will be safely prescribed by the doctor on an individual~     basis and all drugs will be used under the careful watch of your attending physician. All~     the drugs used this study are approved by the FDA for use in adults but they are not~     specifically approved for use in children. However, nearly 7 out of every 10 drugs approved~     for adults are not specifically approved by the FDA for use in children. All drugs used in~     this study will be used in a way that is considered to be safe and reasonable by the~     Children's Hospital.~   "
131901|NCT01328743|"~     This is a randomized clinical trial to examine the effects of a brief counseling~     intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care~     as usual. The study tests the hypothesis that brief counseling will lower drinking in these~     patients and that reductions in drinking will be associated with better HIV-related~     outcomes.~   "
131902|NCT01328730|"~     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating~     patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis,~     MA) has been proved by several randomized clinical trials. Here the investigators design a~     prospective, multicenter, randomized clinical study in purpose of identifying the~     non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES~     (Microport, Shanghai), comparing with Cypher SES.~   "
131903|NCT01328717|"~     Subjects with diabetes and study staff used an investigational blood glucose monitoring~     system.~   "
131904|NCT01328704|"~     The purpose of this study is to observe changes in iron status and vitamin D status during a~     12-24 week supervised training program, specifically males and females between the ages of~     30 and 50 years old.~   "
131905|NCT01328691|"~     Renal cell carcinoma (RCC) has its propensity to invade the venous system, with extension~     into the renal vein and the inferior vena cava (IVC) in 23% and 7%, respectively. Despite~     advances in radiation, chemotherapy, and immunotherapy the reference standard for RCC with~     tumor thrombus remains surgical resection. However, the 5-year survival rate for patients~     who have RCC with venous tumor thrombus treated with radical nephrectomy and tumor~     thrombectomy is only 35% - 45%, despite the developments in surgical technique and~     perioperative care. Furthermore, even the 5-year survival rate for the patients without the~     evidence of nodal or distant metastasis at presentation is just 45% - 65%.~      The outcome prediction for RCC remains controversial, and although many parameters have been~     tested for prognostic significance, only a few have achieved widespread acceptance in~     clinical practice. Currently, pathologic stage (T stage), lymph node status (N stage) and~     histologic grade represent the main prognostic variables in the patients with RCC and venous~     tumor thrombus. Accordingly, the American Joint Committee on Cancer (AJCC) TNM~     classification is regularly revised and, recently, a new 2009 AJCC TNM stage classification~     system has been proposed.~      RCC is more prevalent in developed countries, such as Europe and North America. It is~     relatively less common in Asia; however, the incidence in these regions appears to have~     risen over the past decade. Recently, a few series have suggested that racial or ethnic~     differences in survival persist after controlling for age and stage in some cancers. In the~     case of renal cell carcinoma, it has been demonstrated that the malignancy diagnosed in~     various ethnic groups had different clinical characteristics: the presenting symptoms, the~     course of disease, and the outcome after standard treatment varied significantly between~     patients of Caucasian, Hispanic, African-American, and Asian backgrounds. A recent study has~     reported that race as well as established factors has an impact on survival in patients with~     RCC and Asian Pacific Islander ethnicity was predictive of improved overall or cancer~     specific survival.~      Up to date, there was sparse data on surgical outcome and prognostic factors of survival~     after radical nephrectomy and thrombectomy in an Asian population with RCC and venous tumor~     thrombus, while most studies have been performed in Western countries. The aim of the~     present study was to address the surgical outcome after radical nephrectomy with~     thrombectomy and to evaluate the prognostic factors influencing on survival in Korean~     patients with RCC and tumor thrombus extension into renal vein or IVC, labeled as T3a and~     T3b-c by the newly revised 2009 AJCC TNM staging system, respectively.~   "
131906|NCT01328678|"~     The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects~     with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might~     contribute to the pathogenesis of alopecia areata.~   "
131907|NCT01328665|"~     This project evaluates the effectiveness of an intervention sought to reduce the physical~     effects of stress related to those issues that individuals cannot successfully communicate~     with anyone about. To do this, the investigators will be implementing a writing intervention~     over the course of the 6-week study. The investigators will be asking all participants to~     complete questionnaires over the course of the study period. The investigators are also~     asking participants to provide a small blood sample (from a fingerstick procedure) at two~     times during the study as well as saliva samples during that same time. The primary research~     question asks if this intervention procedure is effective. The investigators are evaluating~     total cholesterol, high sensitivity c-reactive protein, and cortisol.~   "
131908|NCT01328652|"~     Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue~     (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg~     in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy~     (LTH) compared to matched controls receiving placebo.~      Primary endpoints include:~        -  24-hour oropharyngeal pH testing, pre- and post-treatment~        -  Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by~          CT scan of the base of tongue~      Secondary endpoints include:~        -  Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx~        -  Subjective outcome metrics for assessing LPR-related symptoms and associated quality of~          life~        -  Calgary Sleep Apnea Quality of Life Index~        -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale~        -  Epworth Sleepiness Scale (ESS)~        -  Reflux Symptom Index (RSI)~      Specific Aims: The primary objective of this study is to determine whether treatment of~     patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as~     measured on CT scan of the tongue base.~      The secondary objectives of this study are to:~        -  Evaluate changes in LPR-related symptoms and quality of life after therapy using the~          following subjective outcome metrics:~             -  Calgary Sleep Apnea Quality of Life Index~             -  Bed-partner assessment of snoring intensity according to a Visual Analog Scale~             -  Epworth Sleepiness Scale~             -  Reflux symptom index~        -  Correlate changes in LTT thickness with the following secondary endpoints:~             -  Changes in the above subjective outcome metrics~             -  Changes in endoscopic findings of LPR~             -  Changes in 24-hour oropharyngeal pH study results~   "
131909|NCT01328639|"~     Background & Objective: Type 2 diabetes is a complex disease characterized by multiple~     comorbidities. Depression is one of the most common comorbidities in individuals with~     diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment,~     portends worse outcomes and increases health care costs. One novel approach to managing~     diabetes with co-morbid depression is a collaborative primary care model involving a~     multidisciplinary health care team guiding patient-centered care. This model has been tested~     in the US and showed a significant reduction of depressive symptoms, improved diabetes care~     and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of~     this collaborative care model for type 2 diabetes and comorbid depression within the~     non-metro Primary Care Network (PCN) setting in Canada.~      Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2)~     improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle~     behaviours. The intervention is administered by a CM in collaboration with family~     physicians, psychiatrists, and internists.~      Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets~     for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the~     investigators anticipate this intervention will be acceptable and implemented in a~     cost-effective manner in the PCN environment.~      Methods: The investigators will employ a mixed-methods approach to our evaluation, using a~     controlled on-off trial design. Our primary analysis will be based on a multivariable~     scaled marginal model for the combined outcome of depressive symptoms and medical care.~     Secondary analyses will assess changes in lifestyle behaviours and patient-reported~     outcomes.~      Significance: Our work will serve as a platform upon which an emerging model of primary care~     can incorporate an effective and cost-effective depression intervention into the management~     of individuals with type 2 diabetes, and as a framework for implementing and evaluating~     similar interventions in individuals with other chronic conditions.~   "
131924|NCT01328444|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination~     and component, two-period, incomplete block design cross-over study using~     GSK573719/GW642444. The primary objective is to evaluate lung function and exercise~     endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation~     Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg),~     GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel~     DPI)~   "
131982|NCT01327651|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will examine the~     feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery~     will be compared: daily, time-based, and event-based.~   "
131910|NCT01328626|"~     This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of~     ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose~     escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll~     approximately 116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to~     enroll approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were~     enrolled in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose~     escalation portion of the study, with the objective of defining dose limiting toxicities~     (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 60 additional~     CLL/SLL subjects in Arm A and approximately 20 additional DLBCL subjects and 20 additional~     follicular lymphoma subjects in Arm B will be enrolled in an expanded safety portion of the~     study at the recommended phase 2 dose (RPTD) and schedule.~   "
131911|NCT01328613|"~     Background:~      - Postpartum depression (PPD) is a serious syndrome that resembles a major depressive~     episode and occurs in 10% to 20% of all mothers in the year following delivery. Women with~     histories of major depressive disorder (MDD) are at an increased risk for PPD and recurrent~     PPD with subsequent pregnancies. One possible genetic vulnerability to depression and PPD in~     particular is the BDNF gene. BDNF is a protein that affects the growth and development of~     brain cells, including those that help to regulate mood. BDNF levels have been shown to be~     significantly lower in individuals with depression, including women. Researchers are~     interested in studying BDNF levels and hormones such as estrogen in pregnant women who have~     MDD and are at risk for developing PPD.~      Objectives:~      - To study connections between the BDNF protein and hormonal levels in pregnant women who~     are at risk for developing postpartum depression.~      Eligibility:~      - Women who are currently pregnant and have a history of major depressive disorder, and~     either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an~     antidepressant.~      Design:~        -  This study involves six visits over the course of 12 months, during the first, second,~          and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum.~          Women will be allowed to participate at any point during pregnancy, but researchers are~          most interested in recruiting women who are in the first trimester.~        -  Participants will be screened with a physical examination and medical history, blood~          samples, and questionnaires about their history of depressive episodes.~        -  At each visit, participants will complete a number of questionnaires on depression~          symptoms, such as sleep disturbance and stress levels. Participants will also provide~          blood samples for hormone and other testing.~        -  Participants who become depressed during the study will be referred to a treating~          psychiatrist or other professional for appropriate care and treatment.~   "
131912|NCT01328600|"~     Background:~        -  Preeclampsia is a combination of high blood pressure and other potentially~          life-threatening symptoms. Preeclampsia occurs in up to 10% of pregnancies and is a~          main cause of maternal and fetal death worldwide. Treatment is often difficult, and so~          far there is no specific and effective therapy. Researchers have been studying the body~          systems that regulate blood pressure. They have also studied drugs that can control~          certain blood chemicals that constrict blood vessels and increase blood pressure.~        -  DIGIBIND, a drug that lowers blood pressure, has been used to treat pre-eclampsia.~          Marinobufagenin (MBG), a chemical in the blood that constricts blood vessels, has been~          shown to be involved in pre-eclampsia. But researchers are still not certain whether~          DIGIBIND can be used to specifically target MBG. Researchers want to find out whether~          DIGIBIND acts against MBG specifically. This information may help them to develop~          better drugs to block MBG and lower blood pressure in women with preeclampsia.~      Objectives:~      - To study whether the blood pressure treatment drug DIGIBIND specifically acts on~     marinobufagenin levels in the blood of pregnant women.~      Eligibility:~      - Women between 18 and 50 years of age who are 34 to 39 weeks pregnant and have~     preeclampsia.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          and urine tests.~        -  Before delivery, participants will provide blood samples for testing and evaluation.~        -  Following delivery, participants will provide additional blood samples and samples of~          the placenta for testing and evaluation.~        -  No additional treatment, apart from the standard of care, will be provided as part of~          this protocol.~   "
131913|NCT01328587|"~     Background:~        -  Moderate aplastic anemia is a blood disease which may require frequent blood and~          platelet transfusions. Sometimes patients with this disease can be treated with~          immunosuppressive drugs. Not all patients respond and not all patients are suitable for~          this treatment.~        -  Thrombopoietin (TPO) is a protein made by the body. The bone marrow needs TPO to~          produce platelets. TPO may also be able to stimulate bone marrow stem cells to produce~          red cells and white cells. However, TPO cannot be given by mouth. This has led~          researchers to develop the drug eltrombopag, which acts in the same way and can be~          given by mouth. Eltrombopag has been shown to safely increase platelet numbers in~          healthy volunteers and in patients with other chronic blood diseases, including severe~          aplastic anemia. Researchers are interested in looking at whether eltrombopag can be~          given to people with moderate aplastic anemia and significantly low blood cell counts.~      Objectives:~      - To evaluate the safety and effectiveness of eltrombopag in people with moderate aplastic~     anemia or patients with bone marrow failure and unilineage cytopeniawho need treatment for~     significantly low blood cell counts.~      Eligibility:~      - People at least 2 years of age who have moderate aplastic anemia or bone marrow failure~     and unilineage cytopenia,and significantly low blood cell counts.~      Design:~        -  Patients will be screened with a physical examination, medical history, blood tests, a~          bone marrow biopsy, and an eye exam.~        -  Patients will receive eltrombopag by mouth once a day.~        -  Patients will have weekly blood tests to monitor the effectiveness of the treatment and~          adjust the dose in response to possible side effects.~        -  Patients may continue to take eltrombopag if their platelet count or hemoglobin~          increases, their requirement for platelet or blood transfusion decreases after 16 to 20~          weeks of treatment, and there have been no serious side effects. Access to the drug~          will continue until the study is closed. Patients will be asked to return for a~          follow-up visit 6 months after the last dose of medication.~   "
131914|NCT01328574|"~     Background:~      - Urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis) often responds~     initially to standard chemotherapy treatments, but frequently recurs and can often spread to~     other parts of the body. TRC105, an experimental drug that blocks the development of the new~     blood vessels needed for tumor growth, may be able to shrink or stabilize urothelial cancer~     tumors. TRC105 has been given previously to individuals with other types of cancer, and~     researchers are interested in determining its safety and effectiveness in treating~     urothelial cancer.~      Objectives:~      - To determine the safety and effectiveness of TRC105 as a treatment for metastatic~     urothelial cancer that has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with urothelial cancer that~     has spread to other parts of the body and has not responded to standard chemotherapy.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and tumor imaging studies.~        -  Participants will receive TRC105 intravenously once every 2 weeks on days 1 and 15 of a~          28-day treatment cycle. The first dose of TRC105 will be given over a 4-hour period;~          participants who do not have side effects may receive the next dose over 2 hours. If~          the second dose is tolerated, subsequent doses can be given over at least 1 hour.~        -  To help prevent known side effects of TRC105, participants will take two doses (one in~          the morning and one in the evening) of the steroid dexamethasone on the day before each~          infusion is scheduled. Participants may have additional dexamethasone 30 minutes before~          infusion, and may have the infusion slowed or stopped to adjust for side effects.~        -  Participants will be monitored with blood samples, physical examinations, and tumor~          imaging studies through the cycles of treatment.~        -  Participants will continue to take TRC105 for as long as the treatment is effective~          against the cancer and as long as the side effects are not severe enough to stop~          treatment.~   "
131925|NCT01328431|"~     This study will test the effectiveness of an Emergency Department (ED) initiated tobacco~     intervention which includes counseling and medication. Our proposed intervention combines a~     Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as~     well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine~     patches and nicotine gum are provided to subjects in the intervention arm. Subjects~     randomized to the control arm will receive a brochure from the state's Smokers' Quitline~     only.~      The primary hypothesis is that the intervention will be superior to the control condition in~     reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.~   "
131915|NCT01328561|"~     Background:~      - Oxytocin, a substance produced mostly in the brain, plays a role in influencing social~     interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a~     hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and~     reactions to stress, and may also be related to pain. Researchers are interested in~     investigating both substances and their relationship to pain in healthy volunteers.~      Objectives:~      - To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy~     volunteers.~      Eligibility:~      - Healthy volunteers between 18 and 55 years of age.~      Design:~        -  This study involves two 2-hour testing sessions held 1 day apart. Each session includes~          the administration of oxytocin, arginine vasopressin, or placebo (a nonactive~          substance), or no drug. The drugs and the placebo will be given by a nasal spray.~        -  At the first visit, participants will provide blood and saliva samples to measure~          hormone levels, and will be asked to fill out questionnaires about some psychological~          factors such as anxiety and empathy. Participants will then have an assessment of their~          sensitivity to pain, consisting of a brief electrical stimulation that lasts less than~          1 second. After the pain assessment, participants will receive oxytocin, arginine~          vasopressin, placebo, or no drug at all, and will be monitored to provide baseline~          information. Participants will then have another pain sensitivity test and will~          complete the questionnaires again, and provide another saliva sample.~        -  At the second visit, participants will provide another saliva sample; receive oxytocin,~          arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity~          and a pain-relieving procedure. During the pain-relieving procedure, participants will~          receive brief, moderately painful electrical shocks on the back of the nondominant hand~          and a low-level electrical stimulation on the middle finger that counteracts or reduces~          the pain from the shocks. Participants will rate their pain perception at the end of~          each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum~          imaginable pain). The experiment ends with a final saliva collection and completion of~          the psychological questionnaires....~   "
131916|NCT01328548|"~     This study is being done to evaluate the zoster vaccine response in the nursing home elderly~     (80 years or older). As the immune system ages, the response to vaccines is not always as~     strong as in younger people. Previous zoster vaccine studies have excluded nursing home~     residents so the vaccine effect in this population is not known. Furthermore, the immune and~     genetic reasons as to why the vaccine works well in some people but not in others are also~     unknown. The goal of this study is to evaluate why some immune systems respond well to the~     vaccine and why others do not.~   "
131917|NCT01328535|"~     This clinical trial studies individualized temozolomide (TMZ) in treating patients with~     stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as~     TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells~     or by stopping them from dividing. Giving TMZ at different times, which are determined~     individually for each patient based on the phase (biorhythm) of the immune system response~     against the tumor may allow for a better drug response and may kill more tumor cells~   "
131918|NCT01328522|"~     Primary Objective:~      Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after~     a single dose administration in rheumatoid arthritis patients.~      Secondary Objective:~      Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products~     after a single dose administration in rheumatoid arthritis patients.~   "
131919|NCT01328509|"~     The purpose of the proposed project is to investigate measures of zinc status in relation to~     oxidative stress and inflammation in patients with sepsis. We hypothesise that zinc~     depletion can modulate inflammatory responses, leading to increased oxidative stress and~     mitochondrial dysfunction.~      Sepsis is a severe infection is the leading cause of death in critically ill patients [1].~     Zinc deficiency impairs overall immune function and resistance to infection [2]. In vitro~     exposure of monocytes to lipopolysaccharide (LPS) leads to decreased cellular zinc content~     [3] and zinc redistribution has been shown in human volunteers in response to LPS [4]. Zinc~     depletion occurs in hospitalized patients including those with infections, the elderly,~     alcoholics, trauma or burns [5-8], conditions which are common among critically ill patients~     with sepsis. In a mouse model of sepsis, zinc depletion prior to sepsis resulted in more~     inflammation and more severe organ injury and increased mortality [9]. In patients with~     sepsis, early feeding with zinc resulted in faster recovery of organ function compared with~     control [10]. Zinc status is likely to be compromised in the critically ill and that zinc~     depletion may affect inflammatory responses and recovery.~      Although zinc is not an antioxidant itself, it binds to metallothionein [11] and zinc~     supplementation decreases oxidative stress [12]. Oxidative stress has been consistently~     reported in patients with sepsis [13-15]. We have recently shown that protection of~     mitochondrial function with antioxidants can reduce organ damage in rats [16]. Pentraxin-3~     is an inflammatory marker which is regulated in part by antioxidants and plays a key role in~     innate immunity [17].~      The consequences of zinc deficiency may relate, in part, to its effects on nuclear factor~     NFκB, a transcription factor crucial to the signalling networks involved in sepsis [18].~     Higher NFκB activity is associated with increased mortality in patients with sepsis [19,20].~     It is likely that compromised antioxidant defences and inflammation occurs as a consequence~     of zinc deficiency.~      We propose to measure plasma zinc and metallothionein mRNA status in relation to~     inflammatory markers including key cytokines, pentraxin-3, markers of oxidative stress and~     antioxidant status in patients with sepsis.~   "
131920|NCT01328496|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched~     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin~     receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical~     cord blood transplantation (UCBT) using a myeloablative preparative regimen.~      The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation~     (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once~     a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150~     cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at~     60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with~     cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF~     will start on day +1.~   "
131921|NCT01328483|"~     The purpose of the study is to evaluate the role of routine suctioning of the oropharynx~     before the delivery of shoulders in preventing breathing difficulty and subsequent lung~     disease in babies born through meconium stained amniotic fluid. Normally babies do not pass~     meconium while in utero. In response to hypoxic stress babies may pass meconium before birth~     and are likely to be candidates for problems related to meconium passage and its inhalation~     leading to meconium aspiration syndrome(MAS). It is believed that clearing the airways of~     meconium at the time of birth can decrease the risk of MAS. It had been a routine practice~     to suction the mouth, pharynx and nose of the baby as soon as the head of the infant is~     delivered prior to delivery of the shoulders followed by tracheal intubation and suction in~     babies with poor breathing efforts to clear the airways of the meconium. however recent~     studies have shown the futility of this procedure in preventing MAS along with an increased~     risk of complications to baby due to suctioning. In view of the uncertainty regarding the~     effectiveness of this procedure in a resource poor country, the investigators decided to~     evaluate the effect of intrapartum-oropharyngeal suction in preventing or decreasing the~     incidence of MAS in such babies.~   "
131922|NCT01328470|"~     Impaired renal function is associated with reduced responsiveness to clopidogrel. There are~     no studies which have shown a means by which to overcome platelet hyporesponsiveness in~     patients with chronic kidney disease (CKD). The purpose of this study was to determine the~     functional impact of cilostazol in patients with CKD undergoing hemodialysis.~   "
131923|NCT01328457|"~     The purpose of this study is to evaluate the effectiveness of treatment with PMIM in~     patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT~     (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203,~     -15 to +30 days).~   "
131927|NCT01328405|"~     Introduction:~      The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved~     for use as a primary airway and as an aid for intubation in situations of anticipated or~     unanticipated difficult airways. A unique feature of this device as compared to other~     airways on the market is the size of the inner diameter (ID) and length of its airway tube.~     Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.~      The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to~     airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is~     significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a~     maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.~      In this study the investigators aim to test whether the air-QⓇ creates an airway seal~     pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in~     relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the~     LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the~     LMA-ProSealTM.~   "
131928|NCT01328392|"~     Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in~     symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system~     which measures liquid reflux in the esophagus. The investigators are evaluating a new~     24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the~     airway and can be used specifically for LPR diagnosis. The purpose of this study is to~     determine whether the Restech device is more effective than standard pH monitoring in~     predicting the response to proton pump inhibitor (PPI) acid suppression therapy using~     Dexlansoprazole in patients with symptoms and/or manifestations of LPR.~   "
131929|NCT01328379|"~     The purpose of this study is to investigate the safety and efficacy of a lower dose of~     dalfampridine extended release tablets compared to the currently approved dose in improving~     walking in Multiple Sclerosis (MS) patients.~   "
131930|NCT01328366|"~     The impact of psoriasis on an individual's emotional and social well-being goes beyond skin~     symptoms of the disease. Data suggests patients with severe psoriasis experience a greater~     prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation.~     Given the nature of the disease and the treatment failures which are required before a~     patient commences a biologic therapy such as adalimumab, the patient's mental health at~     initiation of biologics is an important consideration for clinicians. This study seeks to~     explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial~     factors and disease-related quality of life.~   "
131931|NCT01328353|"~     The overall objective of this study is to evaluate the effectiveness of a telehealth care~     coordination and case management nursing intervention for children with complex special~     health care needs.~   "
131932|NCT01328340|"~     We are exploring a unique weight-training program for men and women 55 years or older with~     knee osteoarthritis (OA) that emphasizes high-speed movements. We believe that the speed at~     which muscles move may be more important to the improvement of muscle performance, function~     and pain than how strong the muscles are. We are comparing high-speed power training with~     traditional strength training to determine which method has the greatest effects on muscle~     strength, muscle power, speed of movement, functional performance and pain. We believe that~     high-speed training will improve these measures to a greater extent than simply training for~     increased muscle strength.~   "
131933|NCT01328301|"~     This study aimed to explore whether speed-dependent treadmill training is more effective at~     improving walking and balance performance than speed-stable treadmill training in patients~     with subacute stroke. Twenty-six patients with stroke completed 2 weeks of treadmill~     training. Results showed that speed-dependent treadmill training is more effective at~     improving walking speed and step length than speed-stable treadmill training in patients~     with subacute stroke.~   "
131934|NCT01328288|"~     The purpose of this study is to study the HIV disease progression in HIV-infected Thai~     children.~   "
131935|NCT01328275|"~     The purpose of this study is to study the HIV disease progression in HIV-infected Thai~     Adult.~   "
131936|NCT01328262|"~     The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per~     decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag~     transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the~     control group, the prescribed number of red cell units will be transfused.~      Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the~     investigators will reduce the total usage of red cell concentrates.~   "
131937|NCT01328249|"~     The purpose of this study is to assess the feasibility of dose-dense doxorubicin and~     cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast~     cancer.~   "
131938|NCT01328236|"~     Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage~     therapy for Multiple Myeloma (MM).~      The present study is designed to assessment the efficacy and safety study of Bortezomib in~     combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell~     Leukemia (PCL).~      Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is~     the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of~     response (DOR), overall survival (OS).~   "
131951|NCT01328067|"~     The objective of this trial is to evaluate the safety and efficacy of ExAblate for the~     treatment of uterine fibroids.~      Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the~     study.Women who agree to participate will sign an informed consent and will be randomized to~     ExAblate treatment or myomectomy.~      All patients will be followed through the 36 month visit. Follow-up visits/telephone calls~     will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post~     treatment.~      Patients will be evaluated by assessing their overall physical and mental health as well as~     for device/procedure related adverse events.~   "
131966|NCT01327872|"~     This will be a randomized, open-label, four-group, two-period, replicate design study to~     evaluate the effect of food on within and between subject variability in second generation~     formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single~     doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a~     reduction in either the within or between subject variability (coefficient of variation~     [CV]%) of approximately 35%.~   "
131939|NCT01328223|"~     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients~     present with intermediate or advanced disease. Percutaneous ethanol injection,~     radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not~     considered as a curative treatment and have achieved very limited success in eradicating~     large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely~     given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested~     for treating large HCC. Based on the results of these studies, RT could achieve a tumor~     response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the~     overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a~     retrospective clinical investigation with molecular study suggests that sublethal dose of RT~     promoted HCC growth outside RT field.~      Two phase III trials were shown to be efficacious and well-tolerated in patients with~     advanced HCC. Median overall survival was significantly 2 to 3 months longer in the~     sorafenib group than that in the placebo. It is interesting to recognize the combined~     therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor~     angiogenesis inhibitors seem to be synergistic with irradiation when using before RT,~     concurrently with RT, or after RT. Thus, the investigators design a single-arm phase II~     clinical trial to investigate the efficacy of combined RT with sorafenib.~      The eligibility criteria are patients with unresectable HCC; good performance status; no~     prior radiotherapy for the liver; clinical measurable tumor; good liver function and good~     compliance. After entering this study, the testee will receive RT to hepatic tumor with~     concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with~     a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT,~     maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be~     continued until the occurrence of clinical or radiologic progression, or the occurrence of~     either unacceptable adverse events or death. Minimum maintenance duration of 6 months is~     recommended, but not mandatory.~   "
131940|NCT01328210|"~     Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need~     for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is~     a recommended treatment for subjects with obesity and vascular disease. Recent studies~     showed that blood letting with iron depletion may improve insulin sensitivity in patients~     with diabetes mellitus. The investigators aimed to test if traditional blood letting has~     beneficial effects in patients with MS. A randomized trial with a sample size of 64~     self-referred MS patients was conducted. Patients in the blood letting group were allocated~     to blood letting intervention and the control group was offered a later treatment (waiting~     list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and~     after 4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin~     sensitivity as measured by HOMA-Index.~   "
131941|NCT01328197|"~     The primary goal of the study is to assess the safety and performance of the Treovance~     device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the~     diseased pathology can be treated with an acceptable adverse event rate and that the device~     performs as expected. The results of this study will permit the establishment of endpoints~     and clinical design for a subsequent U.S. trial.~   "
131942|NCT01328184|"~     The objective of this study is to investigate the possible effect of multiple oral doses of~     25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and~     levonogestrel (LNG) (Microgynon®).~   "
131943|NCT01328171|"~     The aim of the trial is to optimize response rates and rates of secondary resections of~     metastases in patients with initially non-resectable metastatic colorectal cancer of RAS~     wildtype. The patients will be treated in two therapy groups:~      Experimental arm A: Chemotherapy with FOLFOXIRI + panitumumab Standard arm B: Chemotherapy~     with FOLFOXIRI~   "
131944|NCT01328158|"~     This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify~     the following with regard to treatment with this drug:~        1. Incidence and conditions of occurrence of adverse reactions in the clinical setting~        2. Factors that may affect the safety and effectiveness of Kaletra (QD)~   "
131945|NCT01328145|"~     The pathomechanisms of COPD are still not fully understood, and up to now there is no~     satisfying causal treatment inhibiting the progress of the disease. Available therapy is in~     most cases symptomatic. Experimental and clinical observations suggest that treatment with~     ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional~     improvement.~      To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a~     prospective, randomized, double-blind, placebo controlled study will be conducted. Adult~     male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2~     groups (i.e. 37 patients per group, stratification according to smoking status and gender).~     They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary~     efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory~     1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of~     the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).~   "
131946|NCT01328132|"~     The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular~     hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to~     try to identify the dominant physiological mechanism so that we will be able to better~     identify patients that may benefit from the use of albumin (25%) boluses in addition to~     standard care in patients following liver transplantation.~   "
131947|NCT01328119|"~     Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains~     high. This may at least be partly due to the insufficient removal of (especially~     protein-bound) uremic toxins which have been associated with cardiovascular morbidity and~     mortality. It is unknown whether the combination of long-hour haemodialysis (HD) with~     convection increases the removal of these toxins. Long-hour HD and long-hour~     haemodiafiltration (HDF) may also improve haemodynamic stability which is an important~     factor in treatment quality. The investigators aim to study the removal of uremic toxins in~     long-hour HD and HDF and to compare the haemodynamics between 4-hour and 8-hour HD and HDF.~      Objectives: The primary aim is to study the removal of (especially protein-bound) uremic~     toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic~     response between 4-hour and 8-hour HD and HDF.~   "
131948|NCT01328106|"~     The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an~     effective and safe treatment for cancer subjects with metastatic uveal melanoma and~     mutation-positive GNAQ or GNA11 metastatic melanoma.~   "
131949|NCT01328093|"~     The purpose of this study is to determine whether weight gain will be significantly less in~     LY2140023 than aripiprazole in patients with schizophrenia.~   "
131950|NCT01328080|"~     This study is being done to evaluate the effect of targeted UV-B (a component of sunlight)~     on the treatment of acne keloidalis nuchae (AKN, or razor bumps on the back of the neck).~     The investigators believe targeted UV-B is a safe and effective way to reduce the appearance~     of AKN.~   "
131952|NCT01328054|"~     This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval~     duration) in subjects with advanced solid tumors. The study treatment period will occur over~     five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days~     beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three~     separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as~     three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they~     are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from~     continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration.~     Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1~     (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on~     Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each~     pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who~     complete participation in this study, if they are eligible, will be offered the option to~     continue treatment with lapatinib, either alone or in combination with other oncology drugs~     in pre-selected anticancer regimens, in a continuation protocol, EGF111767.~   "
131953|NCT01328041|"~     The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir~     (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults~     with current or historical failure on an integrase inhibitor (INI) containing regimen. The~     study will assess DTG 50mg twice daily administered initially with the current failing ART~     regimen but then with an optimised background ART regimen (OBR) after Day 7. The first~     analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects~     may remain on study after Week 24.~   "
131954|NCT01328028|"~     The aim of this study is to assess the distribution of the most frequent types of human~     papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.~   "
131955|NCT01328015|"~     A study in which the experimental treatment procedure is compared to a standard (control)~     treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:~        1. To Evaluate the effect of oxybutynin on plantar hyperhidrosis.~        2. To evaluate the effect of oxybutynin in compensatory hyperhidrosis.~        3. To compare the results of questionnaires on quality of life and specific for~          hyperhidrosis to the results of TEWL.~   "
131956|NCT01328002|"~     The purpose of this study is to evaluate the safety, tolerability, efficacy, and~     pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary~     fibromyalgia.~   "
131957|NCT01327989|"~     The objective of this study was to obtain prospective clinical data on the safety and~     efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.~   "
131958|NCT01327976|"~     The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro~     Rechargeable System compared to a sham control for the treatment obesity. The Maestro~     Rechargeable System delivers intermittent, electrical blocking signals to the anterior and~     posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed~     to reduce sensations of hunger and produce satiety leading to weight loss. After approval~     from the institutional review board, subjects provided written consent and were randomized~     in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and~     neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on~     double-blinded basis. Both groups received similar diet and exercise counseling. Weight,~     adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data~     were evaluated throughout the 12 month study duration.~   "
131959|NCT01327963|"~     The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of~     transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of~     gastroesophageal reflux disease (GERD) patients treated at high volume centers across the~     United States.~   "
131960|NCT01327950|"~     This is a national, prospective, multi-center, non-randomized study to evaluate the~     long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial~     Femoral Artery (SFA) lesions. A total of 100 patients will be included in approximately 10~     sites. The study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non-~     inferior to the published patency rates found in the literature. This non-inferiority will~     be established by proving that the true rate for the EPICTM Nitinol Vascular Stent System is~     higher than 82% minus a 10% delta.~   "
131961|NCT01327937|"~     The overall study objective is to use microarray technology to identify and characterize the~     gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.~   "
131962|NCT01327924|"~     This study is conducted in Europe. The purpose of this study is to assess the impact on~     daily life for children new to using a growth hormone injection device.~   "
131963|NCT01327911|"~     This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate~     the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.~   "
131964|NCT01327898|"~     The specific aims of the 5-year study are to: 1) describe the nature and extent of substance~     use and sexual risk behaviors in a sample of 500 sexually active, substance using,~     not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft.~     Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual~     risks; 3) evaluate, through random assignment of participants, the relative effectiveness of~     two intervention conditions in reducing sexual risks and substance use, as measured at 3-,~     6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction~     intervention derived from psychological empowerment theory titled Project GOAL; and, b) an~     enhanced community standard-of-care HIV counseling Comparison Condition.~   "
131965|NCT01327885|"~     This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and~     safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have~     disease progression within 6 months prior to study enrolment following standard therapies~     which must have included an anthracycline, unless contraindicated and then at least one~     additional regimen after failure of the anthracycline.~   "
131967|NCT01327859|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil~     (Aricept) in Parkinson's Disease (PD) patients with dementia.~   "
131983|NCT01327638|"~     The study is intended to provide additional post-marketing safety data regarding the use of~     etoricoxib for the indication of ankylosing spondylitis.~   "
131968|NCT01327846|"~     Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial is to test the~     hypothesis that canakinumab treatment of patients with MI at least one month prior to study~     entry and elevated hsCRP will prevent recurrent cardiovascular events.~      The purpose of the extension phase of the main study is to collect additional long-term~     safety data on continued exposure to canakinumab in patients who participated in the pivotal~     phase.~      Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study is to evaluate the effect of~     quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the~     carotid plaque burden measured by integrated vascular MRI in patients enrolled in the~     CACZ885M2301 study (CANTOS).~      Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study is to determine whether,~     in patients with type 2 diabetes participating in the CANTOS main study, canakinumab~     compared to placebo, on top of standard of care increases insulin secretion and insulin~     sensitivity.~   "
131969|NCT01327833|"~     The purpose of this study is based on method Utstein, registering all recommended items of~     that model, in addition to adding more information, characterizing this way using a template~     Utstein modified for the epidemiology of PCR-hospital in Brazil.~      Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to~     assess demographic and clinical variables such as morbidity, mortality and standard practice~     in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors~     associated with survival in several times and survival curves.~   "
131970|NCT01327820|"~     To define any changes in whole body oxygen consumption that occur following major vascular~     surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and~     infra-inguinal lower limb revascularisation procedures).~   "
131971|NCT01327807|"~     Cure Cystinosis International Registry (CCIR) is an online, patient self-identifying~     registry developed by medical and scientific experts specifically for the cystinosis~     community.~      CCIR's sole purpose is to identify people with cystinosis worldwide in an effort to~     accelerate novel treatments and a cure for cystinosis.~      CCIR provides a safe and secure platform for:~        -  sharing anonymous medical information about cystinosis with researchers, clinicians and~          patients~        -  disseminating information about research opportunities~        -  connecting researchers/investigators and prospective participants *~      Interested cystinosis patients may register themselves with CCIR online at~     http://www.cystinosisregistry.org.~      * No personal information is shared outside of CCIR. Individual identities are known only to~     appropriate CCIR staff. If a participant is matched to a clinical trial, the participant~     receives a notice from CCIR, after which they can decide whether they wish to contact the~     study sponsor.~   "
131972|NCT01327794|"~     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer. It may also help doctors~     predict how well patients will respond to treatment.~      PURPOSE: This research trial is studying the relationship between vitamin D biomarkers and~     survival in blood samples from patients with advanced pancreatic cancer.~   "
131973|NCT01327781|"~     This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride~     in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to~     other places in the body (metastatic) or has come back at or near the same place as the~     original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells.~     Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use~     of estrogen by tumor cells.~   "
131974|NCT01327768|"~     Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1~     to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured~     and expanded under the rule of GTP. Then, quality control of OECs should be done by~     immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators~     will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area~     of the brain.~   "
131975|NCT01327755|"~     Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4~     counts, decrease opportunistic infections, decrease viral loads and delay the need for~     initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.~   "
131976|NCT01327742|"~     This study is a continuation of the pivotal trial studying the safety and efficacy of the~     Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being~     evaluated by the device-related adverse event rate of endovascular repair (via the Relay~     thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse~     events through 1 year in subjects treated with the Relay thoracic stent-graft to those who~     underwent surgical repair.~   "
131977|NCT01327729|"~     The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated~     interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and~     with no prior treatment for hepatitis C virus (HCV).~      Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)~   "
131978|NCT01327703|"~     This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000~     compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis~     (CF) and exocrine pancreatic insufficiency (EPI).~   "
131979|NCT01327690|"~     PTSD (posttraumatic stress disorder) and associated mental health conditions affect both~     veterans and their family members. This study investigates whether group therapy using EFT~     (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in~     PTSD and comorbid symptoms.~   "
131980|NCT01327677|"~     This research is being done to compare two methods of giving fentanyl, a narcotic often~     given to patients following brain surgery and determine if one method has more side effects~     than the other. Both of these methods are available in the postoperative treatment of pain.~     This research also is being done to determine if patients receiving narcotic pain medicine~     will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain~     medicines can slow down breathing, we want to see if measuring exhaled carbon dioxide levels~     will help identify a slower breathing rate and improve safety.~   "
131981|NCT01327664|"~     This study will provide patients who have completed the AIN457 Phase II and Phase III~     clinical trials in non-infectious uveitis continued access to treatment with AIN457 while~     collecting safety data and information on long term clinical use of treatment with AIN457.~   "
131984|NCT01327625|"~     [Study Objectives]~        -  To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid~          combination therapy in patients with bronchiolitis obliterans as a complication of~          allogeneic hematopoietic cell transplantation in terms of response rate at 6 months~          after treatment initiation based on the improvement of FEV1.~   "
131985|NCT01327612|"~     The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG~     479, with or without chemotherapy to subjects without disease progression whose previous~     studies were closed.~   "
131986|NCT01327599|"~     The purpose of this study was to assess the efficacy and tolerability of changing to~     DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with~     open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).~   "
131987|NCT01327586|"~     Randomized clinical trial comparing a money management-based intervention involving storage~     and management of client funds, substance abuse counseling, and risk reduction counseling to~     individualized drug counseling.~   "
131988|NCT01327573|"~     This study is designed to assess the effectiveness of eculizumab in recipients of kidney~     transplantation with donor-specific antibodies (DSA) and worsening kidney function and to~     assess if eculizumab improves endothelial cell injury in the kidney.~      The investigators hypothesize that complement inhibition with eculizumab will reduce~     allograft injury, resulting from less complement-mediated injury of endothelial cells and~     less endothelial cell activation.~   "
131989|NCT01327560|"~     Sleep quality is an important predictor of healthy status,quality of life and life span.~     Sleeping problems affect 50%~80% in hemodialysis patients. Sleep quality and related factors~     research in hemodialysis patients has been discussed and studied globally. Previous studies~     show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs~     syndrome(RLS) are major causes of poor sleep quality . There is few data to show the~     influential factors related to sleep quality in Taiwanese hemodialysis patients.~   "
131990|NCT01327547|"~     To describe liver enzyme elevations in patients who are coinfected with HIV and either~     Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination~     with their current suppressive anti-HIV drug therapy.~   "
131991|NCT01327534|"~     Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary~     arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted~     myocardium.~   "
131992|NCT01327521|"~     Primary Objective:~      To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent~     HCC after initial TACE.~      Secondary Objectives:~        1. To determine the progression-free survival of TACE vs. CyberKnife SBRT~        2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC~        3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment~          of recurrent HCC.~   "
131993|NCT01327508|"~     The objective of this study is to quantitate the amount of radiation both subjects and~     surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT~     Distal Targeting System versus Standard nailing instrumentation.~   "
131994|NCT01327495|"~     The investigators will conduct a three-month, randomized, placebo-controlled trial comparing~     the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the~     prostate in healthy men who are treated with acyline to block gonadal androgen production.~   "
131995|NCT01327482|"~     This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the~     female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug~     levels to prevent viral integration of HIV-1. The study will also assess whether drug levels~     change in the tissue across the different phases of the menstrual cycle.~        -  Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular~          concentrations that should be sufficient to suppress HIV-1 replication throughout the~          menstrual cycle.~        -  Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher~          compared to extracellular concentrations in the plasma and PMBCs (peripheral blood~          mononuclear cells).~        -  Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during~          the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein,~          which are present in higher numbers during periods of high progesterone.~   "
131996|NCT01327469|"~     The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris~     trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the~     most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH~     and more than one billion individuals are thought to be infected, of which 450 million have~     significant morbidity attributable from their infection, school-aged children in particular.~     In this population infections cause stunting of the linear growth, anemia, reduce the~     cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are~     highly prevalent, affecting more than 60% of the children (data not published).~      Current efforts to control STH infections involve periodic mass drug anthelmintic treatment~     of infected children in endemic areas and are likely to intensify as more attention is~     addressed to the importance of these neglected diseases. Monitoring drug efficacy in these~     control programs has become indispensable in order to detect the emergence of resistance~     and/or identify confounding factors affecting the drug efficacy. Recently a study has~     evaluated a single dose albendazole (ALB) in school age children across 7 countries,~     including Ethiopia, revealing that this regime is highly efficacious for the treatment of A.~     lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this~     parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate.~     Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose~     10mg/kg), of which the latter holds promise as it can also be administrated to children~     between 6 months and 2 years. The main objective of the present study, therefore, is to~     assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren~     in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x~     500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).~   "
132011|NCT01327274|"~     This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and~     efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15~     patients aged 8-14 years for the correction of pectus excavatum ('sunken chest'). 3MP for~     pectus excavatum uses a magnetically coupled implant to pull the sternum forward and~     gradually remodel the deformed costal cartilage. The Funding Source for this trial is the~     FDA Office of Orphan Products Development (Grant #R01 FD003341).~   "
132064|NCT01326572|"~     HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected~     patients, and it has been hypothesized that this accelerated disease progression is the~     result of one or more latent infections that amplifies the pulmonary inflammatory response.~     The investigators will examine the prevalence and progression of emphysema in subjects with~     and without HIV and determine risk factors for emphysema in this population.~   "
131997|NCT01327456|"~     Purpose: To determine the role health literacy plays in the care continuum for Chronic~     Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on~     inhaler technique use, time spent on self-management, and knowledge for COPD patients with~     low literacy.~      Participants: The investigators will recruit patients from the University of North Carolina~     at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.~      Procedures (methods): Potential subjects with COPD will be identified through pharmacy~     claims data, clinic billing data and the electronic medical record. Eligibility will be~     prescreened by a research assistant (RA) using the electronic medical record prior to~     approaching potential subjects for consent. For the first part of the study, consenting~     subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler~     technique assessment, and a diary of time spent in self-management activities. Pulmonary~     function tests (PFT) will be performed on all participants for whom PFTs have not been~     conducted within the previous 12 months. The questionnaire will include measures of~     COPD-related knowledge, self-management techniques, quality of care, access, quality of~     life, costs, healthcare utilization, exacerbations, and basic demographic information. The~     inhaler technique assessment will be administered by the research assistant using a~     pre-established protocol. The research assistant will abstract additional data from the~     medical record to assess the quality of care based on adherence to recommended COPD care~     guidelines. For the second part of the study, participants will be randomized to control and~     intervention arms. The self-management intervention will be an interactive experience,~     delivered by a trained research assistant, targeting self-management skills (inhaler use,~     using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. Those~     randomized to the control group will receive usual care. All participants will return 2-4~     weeks after the intervention for a follow-up assessment of inhaler technique, COPD-related~     knowledge, and time spent in self-management.~   "
131998|NCT01327443|"~     The central hypothesis of this proposal is that a reduction in hepatic mitochondrial~     function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and~     NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle~     modifications through aerobic exercise training without weight loss or diet-induced weight~     loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content~     and function in human subjects.~      The investigators propose a randomized, controlled human clinical trial to compare the~     effects of aerobic exercise training (without weight loss) versus diet-induced weight loss~     (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH~   "
131999|NCT01327430|"~     The aim of the study is to investigate parameters of the lipid metabolism in plasma and~     feces of healthy subjects after a dietary supplementation of different dosages of milk~     phospholipids.~   "
132000|NCT01327417|"~     The purpose of the study is to examine the relationship between brain structure and~     depression in adults aged 60 or older. This relationship is determined using magnetic~     resonance imaging technology (MRI), a scanner with a magnet that is used to create images of~     the brain.~   "
132001|NCT01327404|"~     The purpose of the study is to examine the relationship between brain structure and~     depression in adults aged 30 or older with Diabetes. This relationship is determined using~     magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create~     images of the brain.~   "
132002|NCT01327391|"~     The aim of this study is to appreciate the tolerance of on line hemodiafiltration and its~     impact on morbidity and cardiovascular risk factors in chronic renal failure patient.~   "
132003|NCT01327378|"~     The current study explores the incretin effect; a central mechanism of sugar metabolism.~     People with type 2 diabetes have a markedly reduced incretin effect, while the incretin~     effect never has been studied in patients with severe chronic renal failure. Non-diabetic~     patients with severe kidney failure and patients with diabetes and normal kidney function~     share several pathophysiological traits, including decreased sensitivity to insulin, fasting~     hyperinsulinaemia and impaired beta cell function. The investigators expect the incretin~     effect to be affected in patients with chronic renal failure without diabetes, which in time~     can result in therapeutic changes in this group of patients.~   "
132004|NCT01327365|"~     Background:~      The transradial approach is increasingly used in percutaneous coronary intervention (PCI)~     because of lower major access site complications, lower bleeding risk and earlier patient~     mobilization. According to this trend, in the last couple of years at the University~     Hospital of Geneva the investigators have changed their practice and currently the~     transradial approach is the most frequently used for PCI. However, the small diameter of the~     radial artery remains a major limitation of the technique, especially in women or for~     complex PCI necessitating larger bore guiding catheters. This may be overcome with~     sheathless guiding catheters (Asahi, Japan), allowing for a standard inner catheter diameter~     (6-7 Fr), with an outer diameter equivalent to a standard 5 and 6 Fr introducer sheath.~      Aim:~      This study is aimed to compare the transradial approach for PCI with a sheathless guiding~     catheter and with a standard guiding catheter in women and patients with complex lesion~     necessitating large bore guiding catheters.~      Material and methods:~      This prospective study will consecutively randomize all women and all men with~     bifurcation/ostial lesion of a major coronary vessel (i.e. ≈ 120/year) in whom a transradial~     PCI is attempted. The procedures will be performed either with a standard 6 or 7Fr guiding~     catheter or with the sheathless 6.5, 7.5 Fr catheters.~      End-points:~      Successful performance a transradial PCI in all consecutive patients which qualify according~     to the inclusion criteria (technical feasibility). Establish the proportion of procedures~     performed with no device-related complications (safety). Analyze in details the technical~     aspects of the sheathless catheter (efficacy).~      Sample size:~      The investigators have planed to include in the study ≈ 250 patients in two years. After 1~     year of enrollment the investigators will perform an interim analysis and the instigators~     will decide at that moment, according to the observed end-points, if prolonging the study~     would be of any scientific value. In this case another 100 patients will be further included~     in the study.~      Enrollment time:~      The investigators will start the study as soon the local ethical committee will give us the~     permission. The investigators plan to start the study in July 2010. The end is expected for~     July 2012.~   "
132005|NCT01327352|"~     The study will be a non-randomized, open label, single dose, placebo control, single center,~     and single arm study in healthy subjects. The study will include one administration of~     placebo and four single administrations of Oshadi D in two different dose levels,~     administered in two feeding regimen for the evaluation of the influence of food on Oshadi D~     absorption.~   "
132006|NCT01327339|"~     post-marketing surveillance to monitor safety and efficacy of ropinirole during using of~     treatment for RLS~   "
132007|NCT01327326|"~     The aim of this proposal is to characterize pain inhibition in healthy controls and~     Temporomandibular Disorder (TMD) patients with two models of endogenous pain modulation~     (off-set analgesia; conditioned pain modulation), and to investigate the function of the~     endogenous opioid system in these responses by using pharmacological blockade of the opioid~     receptor.~   "
132008|NCT01327313|"~     The primary objectives are to assess the safety and tolerability of single and repeated~     doses of EMD525797, and characterize Pharmacokinetics (PK). The secondary objectives are to~     investigate the immunogenicity and Progressive disease (PD), and to assess the anti-tumor~     activity of EMD525797.~   "
132009|NCT01327300|"~     The purpose of this study is to find whether treating patients with diarrhea predominant~     Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help~     improve their symptoms of diarrhea, bloating and abdominal pain.~   "
132010|NCT01327287|"~     This study is designed to analyze the use of early aggressive pain management with thoracic~     epidural in eligible patients with blunt thoracic trauma.~   "
132012|NCT01327261|"~     A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and~     benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix~     S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche~     Pharma, Switzerland) to assess their relative bioavailability. After administration of each~     formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic~     parameters (AUC, Tmax and Cmax) are compared.~   "
132013|NCT01327248|"~     The aim of this case-control study is the characterization of the bronchial and systemic~     inflammation of children and young adults with bronchiolitis obliterans.~      On the first visit subjects are asked to perform a lung function test (spirometry, body~     plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample~     is drawn to describe the inflammatory status. Bronchial inflammation will be measured in~     induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1~     methacholine) is performed.~   "
132014|NCT01327235|"~     The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin~     alone or Endostar alone in patients with malignant pleural effusion or ascites.~   "
132015|NCT01327222|"~     The purpose of this study is to compare the effectiveness of intravitreal bevacizumab~     injection (IVBI) with respect to simple observation in patients with subfoveal choroidal~     neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at~     baseline with best corrected visual acuity (BCVA) less than 20/200.~   "
132016|NCT01327209|"~     Verify the following with blood glucose monitoring system:~        -  precision and accuracy versus YSI reference~        -  user evaluation~        -  labeling comprehension~   "
132017|NCT01327196|"~     The objective of this project is to study cognitive yields in people of the town of~     Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of~     cognitive impairment in order to detect mild cognitive impairment and study the relationship~     between the clinical situation and cardiovascular risk factors. It will depart from a~     reference population of 420 people older than 65 years living in the municipality of~     Salamanca which took part in a survey prior to partner health needs of the elderly of 65~     years in the municipality of Salamanca. This was a stratified sampling as stratum~     considering the area of health. The results of this study are expected to evidence the~     extent of the problem of cognitive decline in the population over 65 years. It is also~     expected to determine the relationship between the co-morbidity in this problem and specific~     factors of cardiovascular risk in this group of population.~   "
132018|NCT01327183|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and~     safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI)~     undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive~     an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before~     PCI. Follow-up will be for 4 months.~   "
132019|NCT01327170|"~     The aim of this study was to evaluate safety and therapeutic response to micropulse diode~     810nm laser treatment in patients with chronic central serous chorioretinopathy.~   "
132020|NCT01327157|"~     -  The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation~          (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in~          symptoms of masticatory dysfunction.~        -  According to Carvalho (2009) patients with PFP have chronic unilateral masticatory~          preference. Santos et al. (2009) in the same year noted that these conditions can lead~          to problems with temporomandibular disorder.~        -  Hypothesis- known that performing occlusal adjustment in these patients with chronic~          PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle~          stable, providing a balanced occlusion.~        -  dental cleaning was performed in two groups for the blind study~        -  visual analog scale -To assess the quality of the oral functions of these patients, the~          investigators applied the visual analog scale(VAS) and statistically evaluated the~          degree of satisfaction regarding the functions of oro facial in relation to mastication~          and temporomandibular dysfunction.~        -  gnathostats models were made in the treatment group in the first and last query~        -  occlusal adjustment in treatment group.In the group treated occlusal adjustment was~          made in the teeth and applied a new (VAS) before and after treatment.~      The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a~     guide to a harmonious development of the face, chewing facilitating bilateral and~     alternating. (Planas, 1997). It works through selective grinding on the occlusal platform,~     providing an increased number of dental contacts.~   "
132021|NCT01327144|"~     Herpes Zoster is an infection that affects part of the nervous system caused by Varicella~     Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often~     associated with significant pain.~      There are effective oral prescription antiviral medicines available to reduce the discomfort~     of symptoms as famciclovir and aciclovir.~      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy~     and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in~     patients with Herpes Zoster.~   "
132022|NCT01327118|"~     The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of~     brain vessels.~   "
132023|NCT01327105|"~     The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first~     permanent birth control method that can be performed in the comfort of a physician's office~     without hormones, cutting, burning or the risks associated with general anesthesia or tubal~     ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix~     without incisions. Over the next three months, the body forms a natural barrier around the~     micro-inserts to prevent sperm from reaching the egg. Three months after the Essure~     procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is~     called a hysterosalpingogram and evaluates the location of the inserts and whether the~     fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to~     evaluate the location of the inserts.~      The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective~     method of confirming micro-insert location.~   "
132033|NCT01326975|"~     In this study, the investigators want to observe how continuous positive airway pressure~     delivered by two different modalities affects breathing pattern in small preterm infants.~     Using a specialized feeding tube in the stomach, the investigators can measure and compare~     how the diaphragm (a large breathing muscle) might be affected by those two modalities.~   "
132024|NCT01327092|"~     One aim of this study is to test the efficacy of the installation of multiple, passive~     measures to reduce exposure to injury hazards in the homes of young children of first-time~     mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers~     and children who benefit most from the intervention and examine the potential moderating~     effect of maternal depressive symptoms, the intensity of supervisory behavior, and child~     temperament and activity, on the intervention and subsequent injury outcomes.~      Specific Aim 1 Hypotheses:~      H1.1: The housing units randomly assigned to the intervention group will have a significant~     decrease in the number and density (number per area) of residential injury-related hazards~     compared with control group units.~      H1.2: Children who are randomized to the intervention group (e.g. installation of multiple,~     passive measures to reduce exposure to residential injury hazards) will have a 50% reduction~     in modifiable and medically-attended injuries compared with children in the control group~     followed-up for 24-months in intention-to-treat analyses.~      Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the~     effects of the intervention on childhood injury in the home; households and children of~     mothers with higher levels of symptoms will have more hazards and injuries.~      H2.2: Children of mothers with less intense maternal supervisory behavior over the course of~     the intervention follow-up will have higher rates of injury.~      H2.3: Children scoring high in activity on the Carey Temperament Scale will experience~     reduced benefits of the intervention on childhood injury in the home.~   "
132025|NCT01327079|"~     This proposed investigation will test the following hypotheses: 1) Enzymatic activity of~     CYP2B6 characterized by the formation clearance of methadone to EDDP (CLf,EDDP), is directly~     related to both gestational and postnatal age; 2) variations in the CYP2B6 gene (SNPs) are~     associated with variable activity of the CYP2B6 enzyme (as measured by the formation~     clearance, CLf,EDDP), and 3) the elimination rate of methadone and its major metabolite EDDP~     in neonates is dependent on the glomerular filtration rate and therefore on the stage of~     development (defined by both gestational and postnatal age). The investigators propose to~     develop a PK model for methadone dosing in neonates that takes into account both~     developmental stage and genetic variability. The long-term goal of the proposed~     investigations is to improve dosing of methadone in neonates exposed to opioids in utero or~     post-natally, leading to improved control of their withdrawal syndrome and decreased adverse~     drug reactions associated with the current use of methadone in these vulnerable patients.~     More immediately, the investigators will develop a PK model for methadone dosing based on~     relevant developmental and genetic characteristics. The acquired knowledge based on the~     proposed study will lead to a more efficacious treatment of pain or opiate withdrawal~     syndrome in newborn infants with a decreased chance of adverse drug reactions.~   "
132026|NCT01327066|"~     The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at~     clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and~     moxifloxacin in healthy male and female subjects.~   "
132027|NCT01327053|"~     This study will assess the efficacy and safety of oral treatment with two dose levels of~     LDE225 in patients with locally advanced or metastatic BCC.~   "
132028|NCT01327040|"~     Circadian rhythm disorders are a class of sleep disorders characterized by misalignment~     between the timing of sleep and the timing of rhythms driven by the biological clock. Light~     therapy can effectively treat these disorders, but the intensity and duration of light~     exposure required to do so has limited its practical use. In this study the investigators~     will test whether pre-exposure to dim light may enhance the response of the circadian system~     to light therapy. If so, this could result in shorter treatments that would have greater~     practical applications.~   "
132029|NCT01327027|"~     This research is being done because we wish to understand how a chemical produced in the~     brain, vasopressin, effects emotional social communication processes. Understanding how this~     system works in normal individuals may help us understand why some people, particularly~     those with autism and/or antisocial personality disorder, have dysfunctional social~     interactions.~      This study will test the effects of 3 doses of arginine vasopressin, delivered intranasally,~     on physiological and behavioral responses to the faces of same- and other-sex individuals in~     healthy men and women.~   "
132030|NCT01327014|"~     The purpose of this study is to demonstrate the efficacy of XueZhiKang to improve plasma~     lipid profile, as compared to placebo, in outpatients with hyperlipidemia.~   "
132031|NCT01327001|"~     Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol~     or salmeterol/fluticasone) in the Czech Republic.~      There is a hypothesis that doctors should prescribe to each patients per year: six units of~     fixed combination budesonide/formoterol, or seven units of fixed combination~     budesonide/formoterol in approach SMART, or twelve units of fixed combination~     salmeterol/fluticasone. With regard to current prices the treatment by fixed combination~     budesonide/formoterol should cost less.~      The investigators do not have any data about real life utilization of fixed combination in~     asthma treatment in Czech Republic The investigators propose to conduct a non-interventional~     multicentric retrospective epidemiological study looking into the patients records kept by~     specialist - allergists and pulmologists.~      Retrospective data for eligible patients will be reviewed by participating investigators,~     physicians taking care of their patients, and recorded in the electronic CRF. Only patients~     who have been treated for asthma bronchiale (classification of severity - moderate or severe~     persistent asthma) with fixed combination for at least one year could be included into the~     study. There are no scheduled visits for any patient participating in the study.~   "
132032|NCT01326988|"~     The traditional landmarks to locate the injection site and orientation of the spinal needle~     for spinal anesthesia are based on palpation of surface bony landmarks. However the actual~     injection target into the CSF is located at an unknown depth inside the patients 3~     dimensional spinal anatomy which can itself vary in its orientation relative to these~     surface markers.Also bony surface markers may not be palpable in some patients or the~     patient may have altered spinal alignment. Thus an already blind procedure can become even~     more misguided involving multiple trial and error needle insertions. On the other hand~     ultrasound allows visualisation of deep target structures which are impalpable, it allows~     assessment of spinal alignment and thus directs the orientation of the seeking needle more~     accurately. Performing US in real-time during needle insertion gives continuous feedback~     about the correct needle approach path which should reduce the number of blind needle~     passes.~   "
132034|NCT01326962|"~     This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra~     (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an~     inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients~     will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks~     for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the~     study. Anticipated time on study treatment is 24 weeks.~   "
132035|NCT01326949|"~     Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It~     can extend downstream to the portal branches, or upstream to the splenic and/or the~     mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic~     patients. Recent studies demonstrate that the presence of PVT is not only an independent~     predictor of failure to control active variceal bleeding and prevent variceal rebleeding,~     but also significantly associated with increased mortality in patients with liver cirrhosis.~      However, in recent American Association of the Study of Liver Disease (AASLD) practice~     guidelines and Baveno V consensus on management of PVT in cirrhotic patients, no treatment~     strategies in cirrhotic patients with PVT was clearly recommended due to the absence of~     randomized controlled trials.~   "
132036|NCT01326936|"~     This project seeks to develop a comprehensive, computer-based education program for primary~     care physicians that will improve their skills in structured substance abuse screening,~     brief interventions, and referral and treatment (SBIRT). The investigators will develop two~     online education programs based on virtual patient (VP) technology. One program will include~     five typical, interactive, problem-solving VPs and the second will include five identical~     VPs except that two VPs will have been worked by substance abuse experts and presented as~     case studies. The remaining three VPs will be unworked (typical VPs). The investigators~     hypothesize that both education programs will significantly improve educational outcomes,~     compared to no training, as measured by a validated survey tool. A secondary hypothesis is~     that physicians using the worked (guided learning) program will achieve similar~     educational results as those using the typical VP approach, but will require less training~     time.~   "
132037|NCT01326923|"~     This is an open label, single arm Phase II study of induction chemotherapy followed by~     concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell~     cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced~     HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated~     initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed~     by a week of no treatment for interim evaluation, followed by definitive concurrent~     chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The~     hypothesis of the study is that the use of cetuximab during induction chemotherapy followed~     by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve~     local control as well as distant spread.~   "
132038|NCT01326910|"~     This three week study will be conducted to determine the safety and efficacy of an~     over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.~   "
132039|NCT01326897|"~     The purpose of the study is to learn how to make homes more supportive of healthy eating and~     physical activity. As part of the study, participants will be randomly assigned to one of~     two groups. One group will receive materials with information on healthy eating and physical~     activity. The materials will be mailed 3 times over a 5 month period. The other group will~     work with a coach to make their homes more supportive of healthy eating and physical~     activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a~     5 month period. This group will also receive materials by mail 4 different times. All~     participants will be asked to complete 7 telephone interviews over a 1 year period.~     Participants will also be asked to wear an accelerometer, a small portable device that~     tracks movement from physical activity, for 7 days at 2 different points in the study.~   "
132040|NCT01326884|"~     A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day~     information on use of the Zenith LP AAA Graft.~   "
132041|NCT01326871|"~     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation~     study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or~     containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial~     cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to~     evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose~     (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and~     gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of~     ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study~     includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II~     has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for~     platinum-refractory patients, consisting of two treatment arms based on the patient's renal~     function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion~     is complete.~   "
132042|NCT01326858|"~     The purpose of this study is to assess the ocular comfort and safety of olopatadine~     hydrochloride opthalmic solution. 0.7%.~   "
132043|NCT01326845|"~     The objective of the study is to evaluate and compare the frequency and severity of GI~     adverse events in different dose administration regimens. The patient population consists of~     low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional~     iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day~     deferasirox or an evening dose of the same. Patients are then followed up for 6 months for~     any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.~   "
132063|NCT01326585|"~     Dexamethasone is a medication that has been shown to have clear anti-nausea,~     anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage~     postoperative symptoms of a variety of surgical procedures. However, its effect has not been~     validated for scleral buckling surgery, which is used to treat retinal detachment, a medical~     emergency that can lead to permanent blindness. In this study, the investigators will~     randomly administer dexamethasone to half of scleral buckling surgery patients, and a~     placebo to the other half. The investigators will then compare the postoperative symptoms of~     the two groups in order to determine whether dexamethasone should be used for scleral~     buckling surgeries.~   "
132044|NCT01326832|"~     Using the traditional and hitherto used uncemented hip prostheses achieved good clinical~     results, but one of the drawbacks is the risk of fracture in the femoral shaft in~     indbankning of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the~     years after surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss~     increases the risk that in the years after surgery, the increased risk of fractures around~     the prosthesis and in addition to impeding the described bone replacement prosthesis later.~      The newly developed prosthesis is anchored in the femoral neck and thus not involve the~     femoral shaft. This ensures a more physiological or normal weight transfer to the femur~     bone.~      This contributes to bone mass in long large extent preserved in the years after surgery, so~     you have a better opportunity later to make a new prosthesis surgery with good results. The~     new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in~     the first year after surgery.`~   "
132045|NCT01326819|"~     Observational comparison study of three commercially available regional oxygen saturation~     devices on a wide range of skin colors.~   "
132046|NCT01326806|"~     The purpose of this study is to test the efficacy of a parent-based intervention designed to~     prevent adolescent sexual risk behavior in Latino and African American inner city youth. The~     intervention will be administered in the context of mothers waiting for their children to~     complete an annual physical exam required for school admission.~   "
132047|NCT01326793|"~     This study aims to determine whether using telecommunication tools, specifically web pages~     containing online screening instruments and real-time video chat, will be an efficient way~     to implement Major Depressive Disorder screening among college students. The study also aims~     to determine if proactive depression screening and free online consultation with a~     psychiatrist will increase the rate of help-seeking among college students with MDD.~      Eligible participants will complete a demographics survey and depression screening~     assessment online. Those subjects who express suicidality or depressive symptoms will be~     offered the opportunity to complete a one-time psychiatric consultation with Skype~     video-conferencing.~   "
132048|NCT01326780|"~     A study to determine if three different doses of a new acne treatment are safe and better at~     reducing facial acne than a treatment without active ingredient.~   "
132049|NCT01326767|"~     This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC)~     chemotherapy naive patients with good performance status. In course of this study, patients~     will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a~     maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic~     driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia,~     compared to conventional Paclitaxel dosing, without affecting progression free survival and~     overall survival.~      This study includes a biomarker analysis and an optional genetic substudy.~   "
132050|NCT01326754|"~     Background: Malaria is a cause of substantial morbidity and mortality in Malawi. Prompt and~     effective treatment of uncomplicated malaria remains a key strategy to reduce the public~     health burden of malaria. Due to the rising resistance to and falling efficacy of~     sulfadoxine-pyrimethamine, the first-line treatment of uncomplicated malaria from 1993 to~     2007, the National Malaria Control Program (NMCP) revised the national treatment guidelines~     in 2007. The revised treatment guidelines recommend artemether-lumefantrine as the~     first-line treatment for uncomplicated malaria and artesunate-amodiaquine as a second-line~     treatment for uncomplicated malaria. The change in policy was based primarily on efficacy~     data from other countries in sub-Saharan Africa. However, although both~     artemether-lumefantrine and artesunate-amodiaquine have been in use in Malawi since 2007,~     there are relatively few studies assessing their efficacy. In a study conducted in 2004-2006~     in Blantyre, artemether-lumefantrine was found to be efficacious.1 In addition, a more~     recent assessment of artemether-lumefantrine in vivo efficacy conducted in six sites in~     Malawi in 2009 also suggests that the standard formulation artemether-lumefantrine remains~     highly efficacious (Kamija Phiri, personal communication).~      Although, some Malawi-specific data on the in vivo efficacy of the standard formulation of~     artemether-lumefantrine exists, there are additional data that is needed to support the~     current policy and inform future policy decisions. In 2010 the NMCP has introduced the~     dispersible formulation of artemether-lumefantrine (Coartem-D™) for use as a first-line~     antimalarial in Malawi, due to the global unavailability of the standard formulation of~     artemether-lumefantrine from Novartis, the key supplier of the standard formulation of~     artemether-lumefantrine (Coartem™) in Malawi. In light of these developments, an assessment~     of the efficacy, safety and tolerability of the dispersible formulation of~     artemether-lumefantrine is warranted. In addition, the efficacy, safety and tolerability of~     co-formulated artesunate-amodiaquine, the current secondline treatment for uncomplicated~     malaria, has never been assessed in Malawi and should be evaluated. Lastly,~     dihydroartemisinin-piperaquine has recently been added to the new World Health Organization~     (WHO) guidelines for the treatment of uncomplicated malaria. This promising new antimalarial~     might have a role as a first-line or second-line antimalarial for the treatment of~     uncomplicated malaria, but there are no efficacy and safety data from Malawi. This knowledge~     gap needs to be addressed to help inform policy makers about the potential role of~     dihydroartemisinin-piperaquine for the treatment of uncomplicated malaria in Malawi.~      Objective: Efficacy and safety of the dispersible formulation of artemether-lumefantrine,~     co-formulated artesunate-amodiaquine and co-formulated dihydroartemisinin-piperaquine for~     the treatment of uncomplicated Plasmodium falciparum malaria at Machinga District Hospital-~     Malawi~      Methods: An antimalarial drug efficacy trial will be conducted in Malawi. The participants~     will be febrile people 6-59 months old with confirmed uncomplicated P. falciparum infection.~     Patients will be sequentially allocated to receive treatment with either the dispersible~     formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body weight of artemether and~     lumefantrine, respectively, per dose, given twice a day for 3 days; or co-formulated~     artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine once~     a day for 3 days; or co-formulated dihydroartemisinin-piperaquine at a dose of 4 mg/kg/day~     dihydroartemisinin and 18 mg/kg/day piperaquine once a day for 3 days. Clinical and~     parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug~     effi¬cacy. The study will be conducted from January to December, 2011. The results of this~     study will be used to assist the Ministry of Health in Malawi in assessing the current~     national treatment guidelines for uncomplicated P. falciparum malaria.~   "
132051|NCT01326741|"~     Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some~     patients experience anaphylaxis is association with exercise, a disorder called~     exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially~     those with hypotension during the anaphylactic episodes, have been shown to have abnormal,~     clonal populations of a certain cell type, mast cells, in the bone marrow. This has been~     described in at least one patient with exercise-induced anaphylaxis. The investigators would~     like review the findings in a group of patients with exercise-induced anaphylaxis who have~     undergone evaluation for the presence of abnormal, clonal mast cells.~   "
132052|NCT01326728|"~     Background:~      Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem~     cells) have been used with varying degrees of success as an immune therapy for blood-system~     cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some~     people s cancer remains active (comes back or continues to spread) after an allotransplant,~     while other people s cancer disappears and they are hopefully cured . NIH researchers are~     studying the reasons for these different treatment outcomes, and trying to develop better~     cancer treatments for people with active cancer after allotransplant. Researchers are~     collecting data from people who have had allotransplants for a cancer of the blood, whether~     or not the cancer is in remission, and from their donors. Those with active cancers may be~     eligible to participate in one of several NIH studies testing treatments for active cancer~     after allotransplant.~      Objectives:~        -  To develop a systematic, comprehensive evaluation of individuals with relapsed~          malignant blood cancers after allotransplant (and, if available, their donors) to~          identify potential treatment study options~        -  To compare the immune system after allotransplant between people whose cancers are~          growing with people whose cancers remain in remission.~        -  To compare the immune system after cancer relapse/progression treatment between people~          whose cancer responds to treatment with those whose cancers continue to grow.~      Eligibility:~        -  Individuals whose blood system cancer grows or comes back after receiving~          allotransplant treatment.~        -  Individuals whose blood system cancer is responding or in remission 100 days or more~          after receiving allotransplant treatment.~        -  Related stem-cell donors of eligible allotransplant recipients.~      Design:~        -  Participants will be evaluated with a full physical examination, detailed medical~          history (for recipients, including a history of allotransplant treatment process,~          side-effects, etc.), and blood tests. Recipients will also have imaging studies,~          possible tissue biopsies, quality of life questionnaires/assessments, and other tests~          to evaluate the current state of their cancer, whether active or in remission. In some~          cases, it may be possible to substitute results from recent tests and/or biopsies.~        -  Healthy related donors will have apheresis to provide white blood cells for study~          and/or for use in potential treatment options. If stem cells would be medically helpful~          to a recipient, their donors might be asked to take injections of filgrastim before the~          apheresis procedure to stimulate the production of stem cells for collection.~        -  As feasible, all recipients will be asked to return to the NIH for detailed follow-up~          visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and~          may be monitored between visits.~        -  Recipients whose cancers are active and who are found to be eligible for treatment~          protocols at the NIH will continue to be monitored on this study while participating on~          treatment protocols. Return visits and follow-up tests for this study will be~          coordinated with those required by the treatment protocol.~        -  Participants may return in the future to be evaluated for new treatment study options~          (recipients) or additional cell donations for therapy (donors).~   "
132053|NCT01326715|"~     Background:~      - Contrast agents are drugs that make certain body areas or abnormalities show up better on~     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI~     contrast agent with manganese that has been approved for MRI scans of the liver and~     pancreas. Because contrast agents with manganese have also been shown to be useful in~     studying problems with the nervous system, researchers are interested in determining if~     mangafodipir may be used for MRI scans of the brain or eye, two areas that often experience~     problems caused by disorders that affect the nervous system, such as multiple sclerosis.~     However, more information is needed on whether mangafodipir will be useful for this purpose,~     or how best to use it in MRI scans of the eye and brain. To study mangafodipir more closely,~     researchers are interested in studying its use in both individuals with multiple sclerosis~     and healthy volunteers.~      Background:~      - Contrast agents are drugs that make certain body areas or abnormalities show up better on~     imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI~     contrast agent with manganese that has been approved for MRI scans of the liver and~     pancreas. Because contrast agents with manganese have also been shown to be useful in~     studying problems with the nervous system, researchers are interested in determining if~     mangafodipir may be used for MRI scans of the brain or eye, two areas that often experience~     problems caused by disorders that affect the nervous system, such as multiple sclerosis.~     However, more information is needed on whether mangafodipir will be useful for this purpose,~     or how best to use it in MRI scans of the eye and brain. To study mangafodipir more closely,~     researchers are interested in studying its use in both individuals with multiple sclerosis~     and healthy volunteers.~      Objectives:~      - To evaluate the safety and effectiveness of mangafodipir in imaging studies of nerve~     disorders affecting the eye and brain.~      Eligibility:~      - Individuals between 18 and 70 years of age who either have been diagnosed with multiple~     sclerosis or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          tests.~        -  Participants will have up to 10 outpatient visits for screening and MRI scans over a~          period of up to 2 months. Participants will be divided into Eye and Brain groups, based~          on which area will be studied during the scans. (Participants who have available time~          may be eligible for study in both groups.)~        -  Participants will have an initial MRI scan as part of the screening process.~        -  At the first visit, participants will have a baseline MRI scan once before receiving~          mangafodipir.~        -  Participants will have up to five MRI scans, with the following procedures:~        -  Eye imaging group: MRI scans will be scheduled at specific times between 2 and 48 hours~          after receiving mangafodipir. Eye MRI participants will wear a dark contact lens and an~          eye patch for 30 minutes before receiving mangafodipir, and leave both on for up to 8~          hours. The other eye will remain uncovered.~        -  Brain imaging group: MRI scans will be scheduled at specific times between 48 hours and~          7 days after receiving mangafodipir.~        -  Participants will have a follow-up MRI scan 1 month after receiving mangafodipir. This~          scan is done to see how long mangafodipir may affect MRI images of the brain.~   "
132054|NCT01326702|"~     This phase I/II trial studies the side effects and the best dose of veliparib when given~     together with bendamustine hydrochloride and rituximab and to see how well they work in~     treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or~     have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can~     block cancer growth in different ways. Some find cancer cells and help kill them or carry~     cancer-killing substances to them. Others interfere with the ability of cancer cells to grow~     and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill~     more cancer cells.~   "
132055|NCT01326689|"~     This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and~     safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose~     titration in treating breakthrough pain episodes in adult cancer patients receiving strong~     opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.~   "
132056|NCT01326676|"~     Medications that lower blood pressure and cholesterol are known to improve the shape and~     function of our blood vessels. These improvements include a reduction in the thickness of~     the wall of the carotid artery (the main artery that runs up the neck to supply the brain)~     and a reduction in the stiffness of arteries generally including the main central artery~     -the aorta. Such medications are in the polypill (the Red Heart Pill) that is being used in~     the UMPIRE Study. In UMPIRE, patients' reported adherence to taking the single, once daily~     polypill is being compared to adherence to medications taken as separate tablets (usual~     care).The aim of the PESCA sub-study is to see whether or not the polypill differs from~     'usual care' in its direct effects on blood vessels as shown by ultrasound examination of~     the carotid arteries and assessment of central (aortic) blood pressure.~   "
132057|NCT01326663|"~     Despite the body's natural healing during the first year after a head injury, many veterans~     who have suffered even mild brain injuries find themselves easily upset or fearful as they~     go about their daily lives. While these reactions to the world around them were easily~     managed before the head injury, they now occur with little or no interruption and are~     exceedingly difficult to manage. Such reactions include a sense of always being upset or~     fearful that often makes it difficult to get along with family members, friends, coworkers,~     and employers. This may lead to broken marriages, unemployment, and even homelessness.~      Some people with head injuries try to manage their unmanageable moods by drinking alcohol~     because it can create a sense of calm. However, alcohol's actions are short in duration.~     Most find that they have to drink more and more for a similar calming effect, and they soon~     become dependent on alcohol. This makes working and being part of their families even more~     difficult.~      To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood~     problems in people without head injury. We gave valproate to head injured persons with mood~     problems in a non-blinded study where both the doctor and the patient knew that the~     medicine was valproate and both were optimistic that it would work. In a small sample of~     eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or~     drank much less than before. However, this might have been because both the doctor and~     patient were hopeful that the medication would make the patient feel better or because the~     medicine actually worked.~      The only way to know for sure if the medicine works is to perform a study in which people~     receive either valproate or a sugar pill while neither they nor their doctor know which one~     they are taking. This is called a double blind study, as proposed here, and will involve~     nearly three times as many head injured persons as the first study.~      If it is successful, this study will show that valproate treatment helps head injured people~     manage their moods and allows them to return to families, friends, and work. It will also~     show that they drink alcohol less or not at all, improving their health even further. Then~     doctors will know that they can use this medicine for large numbers of people who suffer~     from head injury and help them to lead normal lives. If the outcome of the study shows that~     the medicine works well, doctors can then use this medicine to treat people with head injury~     immediately after the study results are published.~   "
132058|NCT01326650|"~     Despite significant therapeutic improvements, congestive heart failure (CHF) patients still~     have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an~     accumulating body of evidence from prospective cohort studies that low circulating~     25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality,~     respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that~     vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether~     vitamin D supplementation reduces mortality and increases event-free survival in end-stage~     CHF patients.~   "
132059|NCT01326637|"~     Human factors engineering literature makes clear that appropriate, well-designed and~     well-timed information improves decision making and can reduce mental workload. Data from a~     previous study showed that appropriate, well-designed and well-timed information is not~     present in many primary care encounters with elderly patients. This puts primary care~     physicians at risk of higher mental workload and poor decision making which can affect the~     quality and safety of care delivered to patients. Elderly patients are at particular risk~     because they are more likely to have more comorbidities, medications, and cognitive~     impairments.~      Dr. Karsh and his research team will test an intervention to improve the performance of~     primary care physicians and, thus the safety of primary care of the elderly. The~     investigators will use a randomized experiment, with random assignment at the level of~     patient, to test and evaluate the intervention. The evaluation will involve 4 primary care~     clinics, with 4 primary care physicians per clinic. The investigators will collect data from~     768 patient visits pre-intervention and 1536 patient visits during the intervention.~     Intervention patients will be randomly assigned to the intervention or care as usual.~      The Intervention has two components:~      Pre-visit care coordination:~        -  5-7 days prior to a study patient's appointment with his/her doctor, the doctor's~          nurse/MA will call the study patient and collect pertinent clinical information about~          the patient using a data collection form the investigators call a Patient Overview~          Document or POD.~        -  The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging~          studies, etc., that will be needed by the physician are available to the doctor.~      Team Meeting:~      On the day of the patient's appointment and prior to the beginning of the clinic session,~     the nurse/MA will meet briefly with the doctor to jointly review the POD.~      Hypotheses:~      H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce~     PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit~     satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will~     also improve.~      H2. Patient: The intervention will improve patients' perceptions of their visits on a~     variety of AHRQ CAHPS measures, such as physician knowledge of patient history.~      H3. Patient: The intervention will not impact the number or types of problems addressed~     during the visit.~      H4. Clinic: The intervention will not affect visit RVUs~   "
132060|NCT01326624|"~     The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator~     use in patients with left ventricular dysfunction or advanced heart failure symptoms, who~     have a high-risk for sudden cardiac death but are either not eligible for an implantable~     defibrillator under current guidelines or are not able to receive the device due to their~     condition.~   "
132061|NCT01326611|"~     The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of~     ureaplasma urealyticum and prevention of chronic lung disease in premature infants with~     birthweight < 1250 g and have ureaplasma urealyticum colonization.~   "
132062|NCT01326598|"~     The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia~     risk, other possible adverse effects and weight changes, as well as to compare these~     parameters to prior treatment when patients with type 2 diabetes are initiated and treated~     using V-Go during circumstances as close to normal clinical practice as possible.~   "
132077|NCT01326403|"~     This is a randomized controlled trial comparing the use of tranexamic acid to placebo in~     patients admitted to hospital with a hip fracture.~   "
132065|NCT01326559|"~     Study Objective:~      Primary~      1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel,~     Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence~     with intensity-modulated radiotherapy (IMRT).~      Secondary~        1. To determine the overall response rate.~        2. To determine the locoregional and distant control rate~        3. To determine the progression-free survival (PFS)~        4. To determine the overall survival (OS)~        5. To determine the safety of the induction chemotherapy and concurrent chemoradiation~          plus Cetuximab.~   "
132066|NCT01326546|"~     The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV)~     vaccine (synthesized peptide) Joint entecavir treatment in chronic hepatitis B patients.~   "
132067|NCT01326533|"~     The purpose of this study is to determine the short-term effects of the antimalarial~     medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled~     intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin~     secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.~   "
132068|NCT01326520|"~     The aim of the study is to investigate the influence of a milk phospholipid enriched dairy~     product on subjects with atopic dermatitis determining parameters of the immune status, the~     plasma lipid profile and the skin texture.~   "
132069|NCT01326507|"~     The patients presenting with acute pulmonary embolism and right ventricular dysfunction are~     at high risk for life-threatening events and must be identified in the emergency department~     for adequate care and hospital admission. Echocardiography can identify right ventricular~     dysfunction, but this test is not always available, and echocardiographic criteria of right~     ventricular dysfunction vary among published studies. The primary purpose of this protocol~     is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty~     Acid-Binding Protein) , to identify in the emergency department the patients presenting with~     high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to~     other cardiac biomarkers (BNP, troponin) and clinical score performances that have been~     previously studied to stratify the prognosis of patients with pulmonary embolism in the~     emergency department.~   "
132070|NCT01326494|"~     The purpose of this study is to investigate the benefits of giving filled prescription of a~     medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to~     reduce the need to present to Health Care centres for treatment.~   "
132071|NCT01326481|"~     The purpose of this study is to determine the recommended phase 2 dose and overall safety~     and tolerability of TRC105 when given in combination with capecitabine for the treatment of~     patients with progressive or recurrent metastatic breast cancer.~   "
132072|NCT01326468|"~     Patients with advanced head and neck cancer is at high risk of recurrence at the primary~     site or in the neck. Part of normal treatment is to treat such patients with chemotherapy~     and radiation. The chemotherapy can include Erbitux. The purpose of this study is to treat~     such patients with an additional agent, Torisel. This study tests the doses of Torisel that~     can be safely administered together with radiation and chemotherapy.~   "
132073|NCT01326455|"~     The purpose of this pilot study was to compare two devices and three methods for achieving~     hemostasis after a transradial angiogram while assessing vascular complications and time~     endpoints. The heart has traditionally been accessed through the femoral artery. However, in~     the last 20 years, the radial artery has gained more popularity among physicians and~     patients, thereby offering an alternative to the femoral approach. Various methods of~     applying compression to the radial puncture site have been used, but no research has been~     done to show what best practice is. In this case, best practice would be the most effective~     way of getting hemostasis while limiting complications and ensuring the efficient use of~     nursing and medical resources. It is hypothesized that statistically significant differences~     are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as~     compared with the control Terumo group, without increasing vascular complications.~   "
132074|NCT01326442|"~     The study will test the hypothesis that supplementing the diet of subjects with Metabolic~     Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will~     facilitate weight loss, improve body composition and reduce metabolic and biochemical risk~     factors associated with type II diabetes and cardiovascular disease. Adult men and women who~     meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled~     and embark on a 16 week diet and exercise intervention using a low glycemic index diet with~     or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and~     blood collected at weeks 0 and 16.~   "
132075|NCT01326429|"~     Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized~     patients. The increasing use of diuretics and other medications influencing the water and~     sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte~     disorders. Only little data is available on the frequency and the mechanisms leading to~     hypo-/hypernatremia.~      Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the~     emergency department of a large tertiary university hospital and B.) explore the mechanisms~     leading to the development of dysnatremias by detailed clinical and laboratory examinations.~   "
132076|NCT01326416|"~     Android obesity contributes, via insulin resistance and endothelial dysfunction, to the~     development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often~     associated with metabolic syndrome which includes, whatever the definitions used (National~     Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International~     Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure~     and disorders of the glucide and lipid metabolism. The treatment of the current epidemic~     of obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with~     metabolic syndrome) thus requires new therapeutic approaches.~      A well-balanced diet and a daily physical activity are the indispensable requirements for~     the treatment of obesity and metabolic syndrome. It is possible to associate it to~     pharmacological agents, but the results are often partial and transient. Preliminary data~     suggest that leucine or arginine supplementation could facilitate the loss of fat mass.~     Moreover, the physical exercise has also demonstrated benefits.~      Sessions of physical reconditioning (aerobic work + muscular intensification) associated~     with a program of specific nutritional supplementation by a mixture of Leucine and Arginine~     (in the daytime) could improve the treatment of obese subjects affected by metabolic~     syndrome.~   "
132079|NCT01326364|"~     The purpose of this study is first, to determine whether baseline perfusion characteristics~     of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response~     to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to~     determine whether baseline perfusion characteristics in those patients with resectable~     pancreatic cancer correlate with immunohistologic markers of angiogenesis such as~     microvessel density and vascular endothelial growth factor (VEGF) expression.~   "
132080|NCT01326351|"~     The purpose of this study is to demonstrate that prolotherapy in conjunction with a~     physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia,~     relieves pain and improves function of people suffering of plantar fasciitis, an~     inflammation of the plantar fascia, after basic treatment failure.~   "
132081|NCT01326338|"~     The purpose of this study was to determine the efficacy of nitazoxanide suspension compared~     to placebo in treating prolonged diarrhea in children.~   "
132082|NCT01326325|"~     Long-term opioid therapy is commonly administered for the management of severe cancer pain.~     Increasing doses of opioids are titrated against effects until analgesia is achieved or~     intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor~     antagonist, has been reported to improve analgesia in patients with uncontrolled pain~     receiving high doses of opioids. This study aims at determining the effectiveness of~     ketamine as an adjuvant to opioids in relieving cancer pain.~   "
132083|NCT01326312|"~     The purpose of this study is to determine whether GTx 758 is effective in achieving and~     maintaining castrate testosterone levels in men with advanced prostate cancer.~   "
132084|NCT01326299|"~     The purpose of this study is to compare the postprandial glycemic response of subjects with~     type 2 diabetes when consuming a meal along with beverages containing various combinations~     of nutritional ingredients and fibers versus control beverage.~   "
132085|NCT01326286|"~     This study will primarily compare the effectiveness of surgery and radiation for localized~     prostate cancer, the most common male cancer. It will focus on modern technologies and~     control for differences in patients and treatments that may affect both cancer-related and~     patient-reported outcomes (such as impotence and incontinence). By figuring out what~     treatments work best, in which patients and in whose hands, it will help men with prostate~     cancer make better decisions regarding their care.~   "
132086|NCT01326273|"~     The investigators will assess whether the infusion of autologous CMV-specific T-cells at the~     time of CMV reactivation posttransplant will prevent worsening of CMV virus reactivation~     posttransplant to a level that warrants therapy with antiviral drugs (objectively assessed~     by looking at CMV virus copy number).~   "
132087|NCT01326260|"~     This study involved the medical record review of resuscitation records for all~     severely-injured trauma patients requiring emergent surgical intervention and significant~     acidosis from 2005 through 2009.~   "
132088|NCT01326247|"~     The purpose of this study was to evaluate the effects of Ischia thermal waters nasal~     irrigation on allergic rhinitis and airway inflammation during the period of natural~     exposure to parietaria pollen in children with allergic rhinitis and intermittent asthma.~   "
132089|NCT01326234|"~     The current study seeks to use a computer-based program to target parents of children who~     smoke. Parents will be randomly assigned to either receive personalized feedback about their~     smoking behaviors or not. One month after gathering their baseline information, all~     participants will be asked to complete follow-up questionnaires online assessing their~     smoking behaviors.~   "
132090|NCT01326221|"~     This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and~     emtricitabine (components of Truvada) concentrations within genital tract of male and~     females after a single dose of Truvada®. Concentrations of the active drug will be measured~     in blood (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal~     fluid and rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours~     (2 days), 5 days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy~     days, at least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for~     HIV infectivity.~   "
132091|NCT01326208|"~     The purpose of this study in patients suffering from acute lung injury is to determine~     whether positive end-expiratory pressure (PEEP) setting guided by electrical impedance~     tomography (EIT) influences pulmonary gas exchange, lung mechanics, ventilation/perfusion~     matching and homogeneity of regional ventilation when compared to other PEEP setting~     strategies such as the open lung concept or the ARDSnet protocol.~   "
132092|NCT01326195|"~     This project is designed to develop and test a group-based preventive intervention to reduce~     dating violence and sexual risk behavior among adolescent females with prior dating violence~     exposure.~   "
132093|NCT01326182|"~     This study is to develop and pilot test a new group-based intervention for depressed Latina~     mothers of children with asthma. The investigators ongoing work has identified that close to~     50% of Latina mothers of children with asthma report significant symptoms of depression. The~     intervention will combine asthma education and cognitive-behavioral strategies (e.g.,~     increasing the pleasant activities that you do to help your mood) to address symptoms of~     depression. The investigators hope to improve mothers' mood, their feelings of confidence~     that they can manage asthma, and children's level of asthma control.~      The project has two phases. In Phase 1, the investigators will develop the intervention by~     working on the treatment manual and then conducting focus groups with Latina mothers to get~     input on the intervention. The investigators expect 24 mothers at each of 2 sites (RI and~     PR) to participate in focus groups (8 mothers per group). The group will take approximately~     1-1.5 hours.~      In Phase 2, the investigators will conduct a small pilot of the intervention at both sites~     with new participants. At each site, 4 groups (4 sessions each) will be run. Participants~     will have an equal chance of being placed in the new intervention condition (asthma~     education and mood management), or in a control condition that covers asthma education and~     general topics regarding child health and wellness (e.g., encouraging reading, reducing~     screen time, nutrition). Participants will participate in a baseline research session, in~     the 4 intervention group sessions, and then in two follow-up research sessions (one at end~     of treatment which is expected to occur two months after enrollment, and one at 4-months~     post-treatment). They will complete survey instruments that assess their own depressive~     symptoms, family demographic characteristics, access/barriers to health care, self-efficacy~     to manage asthma, social network support, and family climate, as well as their child's~     asthma symptom frequency. Children 7-12 are included only for the assessment of asthma~     symptoms and lung function, which occurs at baseline, end of treatment, and 4-month follow~     up for 2 weeks at each time point. Participation in Phase 2 is expected to take~     approximately 6 months.~   "
132141|NCT01325558|"~     This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation~     study of ALT-836 in combination with standard of care gemcitabine in participants who have~     locally advanced or metastatic solid tumors. The purpose of this study is to determine the~     maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of~     ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall~     survival of study participants will also be assessed.~   "
132094|NCT01326169|"~     The goal of this study is to reduce impaired driving, risky driving and alcohol-related~     negative consequences among injured emergency department (ED) patients through a telephone~     brief intervention. This study will allow researchers to test a novel method of brief~     intervention that has the potential to be convenient and efficient mechanism to deliver an~     intervention to an at-risk population. Eligible patients will be consented in the ED, will~     receive an assessment and then will be randomized into one of two conditions: 1) telephone~     brief intervention or 2) a comparison control group with a home safety educational program.~     The participant will also receive an appointment for an initial telephone call. Both~     conditions will be provided over three telephone sessions: the initial call (immediately~     following randomization) and two booster calls at 2 weeks and 6 weeks after randomization.~     Participants will provide information about their alcohol use, alcohol-related injuries,~     impaired driving, and other driving related negative consequences at 4, 8, and 12 months~     post-randomization.~   "
132095|NCT01326156|"~     This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral~     osteoarthritis.~   "
132096|NCT01326143|"~     The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of~     ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients~     with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to~     Continuous Positive Airway Pressure (CPAP) treatment.~   "
132097|NCT01326130|"~     CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our~     research team to evaluate the implementation of an integrated and interdisciplinary primary~     care network for prevention and management of cardiometabolic risks (diabetes and~     hypertension) (PCR). The intervention is based on the Chronic Care Model and the development~     of an integrated services network. PCR is to be implemented in 6 territories of Centre de~     santé et de services sociaux (CSSS). A first application for funding was made to Fonds~     Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the~     beginning of the implementation. This application to the PHSI program at CIHR is~     complementary and will ensure an evaluation of the sustainability of PCR and of long term~     effects (40 months after the beginning of the implementation) for patients and for their~     primary care physicians.~      In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working~     with primary care physicians and offering to referred patients a pre-determined sequence of~     clinical interventions over a 2-year-period; 2- a program supporting primary care physicians~     (continuing education, documentation and clinical guidelines, referral system to second line~     of care); 3- networking between actors of Réseau local de services (RLS) insuring clinical~     information transfer required for efficient patient management.~      OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure~     (specifically benefits to registered patients and support to participating primary care~     physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the~     related contextual factors; 3- examine the relationship between the effects identified, the~     degree of implementation of PCR and the related contextual factors; 4- assess the impact of~     implementing PCR on the strengthening of RLS.~      METHODS: The proposed evaluation will be done through a mixed design including two~     complementary strategies. Using a quasi-experiment/before-after design, the first strategy~     is a quantitative approach looking at the program effects and their variation between~     territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP,~     lifestyle) and from patient questionnaire inquiring about care experience, utilization of~     services, chronic care follow-up, self-management and quality of life. Around 3000 patients~     will be enlisted. A primary care physician questionnaire will enquire about PCR effects on~     their practice. Using primarily a qualitative and a case study approach, each of the 6~     territories being one case, the second strategy will identify the degree of implementation~     of PCR and the explanatory contextual factors. This analysis with use data obtained from~     semi-structured interviews with program managers. The results of this analysis will be~     summarized in a monograph for each territory. According to the type of indicator analyzed,~     objective 3 will be fulfilled using linear models or longitudinal multilevel models~     supplemented with an interpretive approach using the information from monographs and~     discussion groups. The impact of implementing PCR on RLS will be assessed through interviews~     with key informants.~      RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual~     factors associated with successful implementation and sustainability of PCR. Detailed~     contextual information will allow application of our results to other environments that have~     similar context and to other chronic conditions that could benefit from an integrated~     services network.~      KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part~     in all phases of PRC evaluation (planning, data collection, analysis and interpretation),~     diffusion of information regarding the program is an integral part of the research process.~     In addition, results will be presented at local, regional, provincial and national~     conferences and published in reports and articles widely distributed. More specifically, a~     regional symposium will be organized to share evaluation results with all CSSS in the region~     (n=12) and with all our local and regional partners.~   "
132098|NCT01326117|"~     The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1~     diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying~     compared to baseline as measured by gastric emptying time.~   "
132099|NCT01326104|"~     Immunotherapy is a specific approach to treating cancer that has shown promise in adult~     patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study~     investigators will use the experience they have gained from these studies to try to improve~     the outcome for children affected by a recurrent brain tumor.~      This study will have two phases.~      During Phase I, approximately 9 patients will be treated with increasing doses of~     tumor-specific immune cells to determine the safety of this treatment. Phase I patients will~     also receive dendritic cell vaccines to help boost the function of these immune cells and~     maintain their growth.~      During Phase II, approximately 35 patients will be treated with tumor-specific immune cells~     and dendritic cell vaccines to see what impact they have on the tumor.~   "
132100|NCT01326091|"~     This is a parallel, randomized controlled trial comparing two types of patient positioning~     and their effect on radiologic measures (pre-surgery visit, in the operating room prior to~     surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients'~     postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and~     patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks~     follow-up).~   "
132101|NCT01326078|"~     The purpose of this study is to compare the safety and efficacy of the of propofol~     nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.~   "
132102|NCT01326065|"~     The purpose of this study is to study the implementation of laparoscopy-assisted surgery for~     cure of colon cancer in daily surgical practice.~   "
132103|NCT01326052|"~     The aim of the study is to evaluate the anorectal function after hemicolectomy if we~     preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that~     IMA preservation could improve patient's quality of life reducing incontinence and/or~     constipation rate.~   "
132104|NCT01326039|"~     Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine~     5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a~     clinically analgesic effect after unilateral open inguinal hernia repair.~   "
132105|NCT01326026|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily~     in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different~     self-titration algorithms (dose individually adjusted) in combination with metformin.~   "
132106|NCT01326013|"~     The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the~     presence or absence of gastrointestinal (GI) pathogens from human stool specimens.~      The objective of this study is to establish diagnostic accuracy of the xTAG GPP.~   "
132107|NCT01326000|"~     This randomized, multicenter, open label study will evaluate the safety and efficacy of~     RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone~     as second line treatment in patients with metastatic colorectal cancer. Patients will be~     randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks~     thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on~     Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study~     treatment is until disease progression or unacceptable toxicity occurs.~   "
132108|NCT01325987|"~     Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency,~     the investigators propose to determine if vitamin D treatment improves glycemic control in~     vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D~     treatment will improve glycemic control and ß-cell function in vitamin D deficient AA~     subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D~     concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional~     glycemic control effects.~   "
132155|NCT01325376|"~     This is a six month lifestyle management study to compare the effects of iWell; a dynamic~     online interactive technology to a self-directed program in overweight or obese individuals.~      The primary aim is to test the hypothesis that dynamic online interactive technology~     intervention is more effective than self-directed program in obtaining and maintaining~     weight loss and other biometric improvements.~   "
132270|NCT01323868|"~     The purpose of this study is to determine the rate of endogenous endophthalmitis in patients~     admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this~     may improve the clinical care of this population of patients.~   "
132908|NCT01315470|"~     The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of~     recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium.~     Several studies showed that GCSF improves embryo development and implantation and increase~     pregnancy rate.~   "
132109|NCT01325974|"~     Background: Antigen-detecting rapid diagnostic tests (RDTs) for malaria provide the~     possibility of a parasite-based diagnosis in areas where good quality microscopy can not be~     achieved.~      P. falciparum tests targeting the histidine-rich protein (HRP2) antigen are generally more~     sensitive than tests targeting the Plasmodium lactate dehydrogenase (pLDH) antigen. However,~     as the HRP2 antigen is eliminated from the bloodstream more slowly than the pLDH antigen,~     HRP2-based tests can give a positive result two weeks or more after the patient has taken an~     effective treatment, while pLDH tests generally turn negative a few days after. The use of~     an RDT positive result in a routine patient care is therefore challenged by the~     interpretation of whether the result is due to a lasting effect of the already treated~     infection or to a new infection. The interpretation might also be affected by the level of~     malaria transmission in the area.~      Objective: The objective of this study is to estimate the proportion of positive tests in~     patients successfully treated for malaria (smear negative) at different time points in time~     after treatment, for three rapid diagnostic tests: SD Bioline Malaria Antigen P.f.~     (catalogue number: 05FK50-02-4), CareStart Malaria HRP2 (Pf) (catalogue number: G0141) and~     CareStart Malaria pLDH (PAN) (catalogue number: G0111). The study will be carried out in two~     settings with known low and high malaria transmission levels in order to provide guidance of~     interpretation of a RDT positive result depending on the intensity of malaria transmission.~      Secondary objectives will be to measure the sensitivity and specificity of the malaria rapid~     tests compared to smear microscopy, to estimate the median time to become negative for each~     of the tests and to estimate the proportion of positive tests and the median time to become~     negative according to the initial parasitaemia and the presence of gametocytes.~   "
132110|NCT01325961|"~     The aim of the study is a medico-economic evaluation to estimate a cost differential between~     three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate,~     cervix and anal canal with pelvic lymph node irradiation : treatment with helical~     Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.~   "
132111|NCT01325948|"~     The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary~     Disease (COPD) on daily life activities in patients with COPD and also to determine the~     socio-demographic profile, daily life style and needs of the patients with COPD.~   "
132112|NCT01325935|"~     A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three~     months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent~     through noninferiority in the primary endpoint between two different continuous regimen~     (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting~     stent in real-world Japanese patients and to examine the optimal duration of DAPT after~     stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present~     clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should~     consist of consecutive patients undergoing DAPT for twelve months after stenting, while the~     short-term DAPT group (to be newly registered in the present clinical study) should consist~     of patients who are instructed to undergo DAPT for three months after stenting.~   "
132113|NCT01325922|"~     Study Description The purpose of this study is to compare the defibrillation efficacy~     between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High~     Voltage Lead Integrity Check (HVLIC) impedance.~      Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the~     50/50% tilt waveform.~      Study Methods~        -  This is an acute, paired-sample, randomized (waveform testing sequence) study~        -  Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude~          Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other~          standard output ICD after Epic+) and defibrillation lead system.~        -  All study testing is completed at implant.~        -  Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned~          waveform.~        -  The HVLIC feature is used to measure the high voltage lead impedance and to program the~          Tuned and 50/50% tilt waveform pulse widths.~        -  The DFT is determined by an optimized binary search method that is designed to reduce~          the overall number of VF inductions to an average of 5.13 while maintaining very high~          resolution and accuracy.~        -  Total # of centers - 15 centers~        -  Sample size - 60 patients~   "
132114|NCT01325909|"~     Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and~     rectal) cancer is associated with improved survival, but also adversely affects physical~     fitness, potentially rendering patients unfit for major surgery or increasing the risk of~     adverse outcome (death and serious complications) after major surgery. The investigators~     have pilot data using an upper gastrointestinal cancer patient cohort showing that~     neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The~     investigators therefore propose a blinded, single centre, prospective interventional trial~     of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS~     teaching hospital.~      The investigators wish to explore various hypotheses:~        1. Is exercise intervention feasible and tolerable in this cohort of patients?~        2. Can fitness be improved using a structured, responsive exercise training programme~          (SRETP)?~        3. Can SRETP improve quality of life?~        4. Can SRETP improve physical activity?~        5. Can SRETP improve surgical outcome?~        6. Can physiological fitness and oncological outcome be matched to identify an optimal~          time for physiological recovery following NACRT prior to major surgery.~      The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30~     patients for an interventional study over 24 months from Aintree University Teaching~     Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed~     to evaluate the ability of the muscle to take up and utilise oxygen, namely a~     cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre−CRT and at 3,6,9~     and 14 weeks post−CRT (pre−surgery). All patients will have their CPET, as well as standard~     restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data~     will also be collected.~   "
132115|NCT01325896|"~     -  Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic~          malignancies. Between 50 and 70% of symptomatic patients presented response to~          induction chemotherapy. The rate of complete responses (CR) achieved with standard~          induction of these treatments is less than 5% of cases and the median event-free~          survival between 2 and 3 years although most of the patients died from the disease.~        -  High dose chemotherapy with autologous stem cell transplant has improved the response~          rate and survival of patient with MM. However eventually all patients relapse with a~          median EFS between 40-50 months post-transplant.~        -  To improve these results and sustain remission, various maintenance treatment have been~          proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits~          in a meta-analysis.~        -  Intron A s.c. need administration of 3 days per week and is not well tolerated~        -  Recently a new formulation of Interpheron alpha2b is available. Conjugated with~          polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in~          MM.~        -  The purpose of this study is to evaluate the role of Pegintron as maintenance after~          autologous transplant in MM~   "
132168|NCT01325207|"~     The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of~     cancerous tumors that are HER-2 positive. Patients are being asked to participate in this~     study because they have been diagnosed with having tumor cells in their spinal fluid. This~     study will investigate the safety and effects of this drug when given directly into the~     spinal fluid.~      Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the~     Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this~     research study is to determine a safe dose of the drug Trastuzumab and then determine how~     effective this treatment is.~   "
132116|NCT01325883|"~     Neoadjuvant chemotherapy (NAC) prior to surgery for upper gastrointestinal (oesophageal and~     gastric) cancer is associated with improved survival. The investigators propose a~     prospective blinded observational cohort study of patients undergoing NAC prior to elective~     upper gastrointestinal cancer resection (oesophagectomy and gastrectomy) in three NHS~     teaching hospitals. The investigators have pilot data showing that NAC reduces objectively~     measured exercise capacity (fitness). The literature suggests that a lower level of exercise~     capacity is associated with a high risk of adverse outcome (death and serious complications)~     after major surgery.~      The investigators wish to explore the hypothesis that decrease in exercise capacity~     (fitness) associated with (NAC) prior to upper gastrointestinal cancer resection may~     outweigh the benefits (duration of survival) achieved by NAC in some patients undergoing~     upper gastrointestinal cancer surgery. The investigators aim to recruit 175 patients from~     over 36 months. Consenting patients will perform cardiopulmonary exercise testing (CPET) and~     complete a quality of life questionnaire prior to and 4 weeks after NAC . Postoperative~     outcomes measured at set time points will be objective recorded including mortality 1 year~     after surgery and short term postoperative harm described by the PostOperative Morbidity~     Survey (POMS) as well as Quality of life scores and resource use (e.g. hospital bed~     utilisation). Exercise capacity (fitness) before and after NAC will be assessed using CPET~     and the relationship between the derived variables (AT, VO2 peak) and clinical outcomes will~     be described.~   "
132117|NCT01325870|"~     More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall~     survival rates averaging less than 5%. Low survival rates persist, in part, because manual~     chest compressions and ventilation, termed standard cardiopulmonary resuscitation (S-CPR),~     is an inherently inefficient process, providing less than 25% of normal blood flow to the~     heart and the brain. Hemodynamics are often compromised further by poor S-CPR techniques,~     especially inadequate chest compression and incomplete chest recoil. Active Compression~     Decompression CPR (ACD-CPR) is performed with a hand-held device that is attached to the~     patient's chest, and also includes a handle containing a metronome and force gauge to guide~     proper compression rate, depth and complete chest wall recoil. The impedance threshold~     device (ITD) is designed for rapid connection to an airway adjunct (e.g. facemask or~     endotracheal tube) and allows for positive pressure ventilation, while also impeding passive~     inspiratory gas exchange during chest wall decompression. Prior studies have shown that the~     combination of ACD-CPR + ITD enhances refilling of the heart after each compression by~     augmenting negative intrathoracic pressure during the decompression phase of CPR, resulting~     in improved cardiac and cerebral perfusion. The intrathoracic pressure regulator (ITPR) is a~     next generation inspiratory impedance therapy. The ITPR uses a regulated external vacuum~     source to lower the negative intrathoracic pressure and is therefore less dependent on the~     quality of CPR (e.g., completeness of chest wall recoil). The ITPR generates a pre-set~     continuous and controlled expiratory phase negative intrathoracic pressure that is~     interrupted only when positive pressure ventilation is needed to maintain oxygenation and~     provide gas exchange.~      The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR,~     ACD- CPR + ITD, and S-CPR + ITPR in patients with out-of-hospital cardiac arrest.~   "
132118|NCT01325857|"~     This study was designed to investigate the analgesic effect of bilateral superficial~     cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The~     investigators hypothesized that bilateral superficial cervical plexus blockade would reduce~     the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo~     group and control group.~   "
132119|NCT01325844|"~     This study was designed to investigate the effects of epidural anesthesia combined with~     general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural~     anesthesia will effectively block the activation of the sympathetic nervous system during~     surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in~     postoperative renal function.~   "
132120|NCT01325831|"~     In order to explore the effect of repetitive TMS, which has shown to be effective in~     intractable depression, we will examine resting-state, default-mode network functional~     connectivity in patients with major depression. We will use a double-blind, sham-controlled~     design. Our target sample size is 60(30 patients will be treated by active rTMS, the other~     30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left~     dorsolateral prefrontal cortex of the subjects.~   "
132121|NCT01325818|"~     The purpose of this study is to compare the effects of pravastatin and rosuvastatin on~     coronary plaque characteristics in patients with stable angina pectoris.~   "
132122|NCT01325805|"~     Overweight and obesity has been associated with a number of adverse pregnancy outcomes in~     women of reproductive age, including infertility and early pregnancy loss. Recent data~     suggests that overweight and obese patients are also at increased risk of recurrent~     pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population.~      The investigators propose a prospective, randomized controlled trial in which overweight and~     obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6~     month, weight loss program or provided routine counseling regarding the importance of weight~     loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic~     outcomes, such as lipid and glucose profiles, will also be evaluated.~   "
132123|NCT01325792|"~     Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue~     Reinforcement when used to reinforce midline fascial closure in single-staged open complex~     ventral incisional hernia repair.~   "
132124|NCT01325779|"~     Study hypothesis: Subcutaneous enoxaparin is more effective than subcutaneous heparin in~     preventing the development of DVT in the general surgical intensive care unit population.~      Hospitalized patients are at increased risk for the development of blood clots in the legs,~     known as deep venous thrombosis (DVT). Surgical patients are in a higher risk category than~     the general hospital population due to a number of factors including undergoing surgery and~     increased risk of immobility. The highest risk patients are in the surgical intensive care~     unit, where their surgical risks for blood clots are combined with issues such as sepsis,~     acquired blood clotting disorders, and increasing age, each of which are factors that~     contribute to the risk of blood clot development. 1. Patients who develop these blood clots~     (DVTs) are at risk for chronic leg swelling, pain, and in some cases, chronic ulcer~     development on the leg. In the worst case scenario, these blood clots can break away and~     migrate to the lungs where they cause a pulmonary embolism (PE), a clot in the lungs that~     can cause significant breathing difficulty requiring intubation and mechanical ventilation,~     and in some cases, death.~      According to recent research, DVTs account for over 200,000 patient deaths each year~     nationwide. 2. A large amount of data has supported the use of medication called heparin or~     enoxaparin in low doses to prevent these blood clots from forming while in the hospital.~     Both of these medications are considered standard of care for use patients considered~     moderate and high risk for the development of DVT. 3. While both of these medications have~     been shown to significantly reduce the occurrence of DVT in appropriate doses, 4. there has~     never been a direct comparison of the two medications in the highest-risk population of the~     surgical intensive care unit. Our own preliminary data suggests patients may have a lower~     incidence of DVTs with the use of enoxaparin versus heparin. Part of the reason for this may~     be the requirement for three times daily dosing of the heparin compared to once daily dosing~     for enoxaparin. There may also be some inherent differences in the efficacy of the~     medications themselves.~   "
132309|NCT01323348|"~     The purpose of this study is to assess whether glycemic control (assessed with HbA1c~     measurement) in individuals with type 1 or type 2 diabetes can be improved with a~     point-of-care measurement of HbA1c in the ophthalmologist's office combined with a~     personalized risk assessment for diabetic retinopathy and other complications of diabetes.~   "
132125|NCT01325766|"~     Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US.~     Incorporation of regular exercise into the lives of patients with CF is of interest because~     it may improve lung function and quality of life. Yoga is an activity that may benefit~     patients with CF in many ways including strengthening muscles of breathing, improving lung~     function, and reducing stress which could improve quality of life and adherence to~     therapies. Yoga has been shown to be beneficial in patients with other lung diseases such as~     asthma, but has not yet been studied in CF.~      The investigators hypothesize that yoga will be an activity that is safe and tolerable for~     CF patients 12 to 25 years of age. The primary aim is to investigate the safety and~     tolerability of an 8 week yoga program for patients with CF. The secondary aim is to~     determine the effect of yoga on many aspects of CF disease including respiratory symptoms,~     adherence to regular CF therapies, quality of life, lung function, exercise tolerance, and~     nutritional status.~      The long-term goal is to use the data obtained in this study to design a future study of the~     efficacy of yoga in a larger population of CF patients at multiple CF centers. This research~     has the potential to influence the prevention and treatment of CF by providing data which~     could be used to help understand the most appropriate and beneficial type of physical~     activity for CF patients.~   "
132126|NCT01325753|"~     This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in~     treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.~   "
132127|NCT01325740|"~     The study will consist of a Screening period (up to 14 days), a Treatment period, and a~     Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or~     30 mg (or matching placebo) across four study centers.~   "
132128|NCT01325727|"~     The purpose of this research study is to find out more about smokers in recovery from~     addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior~     feedback session. The hypothesis is that a brief computerized smoking behavior feedback~     session will motivate more smokers to quit smoking than a control condition.~   "
132129|NCT01325714|"~     This study tests whether education about memory and pain might help to prevent aggression in~     persons with dementia who have pain. The overall goal of this intervention is to reduce the~     risk of aggressive behavior by improving several areas of patient life that are known causes~     of aggression: pain, depression, lack of pleasurable activities, caregiver stress and~     difficulty in caregiver-patient communication.~   "
132130|NCT01325701|"~     The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in~     relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse~     Large B-cell Lymphoma (DLBCL).~   "
132131|NCT01325688|"~     This study is primarily designed to investigate whether treatment, once daily for up to~     three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable~     in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and~     extremities.~   "
132132|NCT01325675|"~     The purpose of this study is to determine the effect of aerobic interval training in~     patients with paroxysmal or persistent atrial fibrillation, especially to see if the burden~     of atrial fibrillation and symptoms are reduced.~   "
132133|NCT01325662|"~     This is a study to evaluate the feasibility and tolerability of low-rate continuous~     Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit~     severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy~     participants.~   "
132134|NCT01325649|"~     The objective of the study is to provide proof that a MRI based preoperative~     radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to~     high risk patients without increase of locoregional recurrence rate and decrease of overall~     survival provided there is a high quality of mesorectal excision.~   "
132135|NCT01325636|"~     The main purpose of this project is to evaluate the efficiency of the injection of CD4 and~     CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the~     first injection (adenovirus infection is not enough usual, especially in adults, to be used~     for the primary purpose and is measured in the secondary endpoints).~   "
132136|NCT01325623|"~     The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model~     106 VNS Therapy System.~   "
132137|NCT01325610|"~     The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That~     has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD)~     (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone~     release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or~     its analogues in CKD. There is very little data concerning use of native vitamin D or~     25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The~     latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on~     outcomes or doses or optimal levels to guide them and so have made a blanket recommendation~     to treat 25D levels in CKD by general healthy population guidelines.~        1. This project focuses on an outcome (calcium absorption) that may be impacted by~          optimizing 25D status in renal patients. The investigators will assume for this project~          that a level of 25D > 32 ng/ml is optimal in CKD patients as in a healthy population.~        2. A secondary outcome is to quantify calcium absorption in CKD patients with and without~          vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles~          25D and 1,25D play in calcium absorption.~   "
132138|NCT01325597|"~     The purpose of this study is to assess the effects of functional electrical stimulation~     associated with inspiratory muscle training on functional capacity and quality of life in~     heart failure patients.~   "
132139|NCT01325584|"~     The purposes of this study are to make Omegaven® available to cancer patients with liver~     disease and to determine if Omegaven® can improve or prevent further liver disease. The~     study will also look at the effects Omegaven® has on immune function.~   "
132140|NCT01325571|"~     To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia~     gravis who are inadequately treated by glucocorticoid.~   "
132332|NCT01323049|"~     The primary objective is to show that positive pressure extubation improves oxygenation~     immediately after extubation compared to extubation via aspiration by evaluating and~     comparing the onset time of desaturation during spontaneous ventilation during awakening~     following general anesthesia.~   "
132142|NCT01325545|"~     About one-third of patients with stroke have no documented cause for the cerebrovascular~     event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but~     when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult~     paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using~     prolonged ambulatory cardiac rhythm monitors.~      The investigators designed this study pursuing the following goals:~        1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with~          cryptogenic stroke using long-term mobile cardiac outpatient telemetry.~        2. To compare this prevalence to that found in a control group with stroke of known,~          non-cardioembolic cause.~        3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as~          risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic~          stroke.~        4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new~          diagnostic tool, in the evaluation of patients with cryptogenic stroke.~   "
132143|NCT01325532|"~     The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps~     improve symptoms of major depressive disorder (MDD). The investigators are studying the~     device's effectiveness in treating depression, as well as its safety. This is a pilot study.~      Eligible participants will be randomly assigned to receive either active CES or sham CES,~     every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES~     treatment for 20 minutes.~      The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome~     measure will be change in patient-reported sleep score.~   "
132144|NCT01325519|"~     The purpose of this study is to compare the decision making of hospitalized subjects having~     a verbal discussion about CPR compared to subjects using a video.~   "
132145|NCT01325506|"~     Prostate cancer is the most common cancer in American men. Surgical removal of the entire~     prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The~     use of robot assistance for prostatectomy has become common place, but its effectiveness has~     not been compared to standard open prostatectomy in trials carried out at more than one~     medical institution in which participants are identified and followed forward in time. Robot~     assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes~     have not been compared in a prospective, multi-centered study. Prostatectomy can have side~     effects that can change with time. This research study seeks to determine how common and how~     long-lasting such side effects are; to find out what features of individual men's cancers~     and what features of the treatments affect those side effects. This study also seeks to~     identify factors that affect the quality of prostate cancer care by looking at how satisfied~     men are with their prostate cancer care. Through these findings, this study aims to allow~     treatment side effects to be anticipated more accurately for individual patients, and to~     provide a means for determining the quality of prostate care.~   "
132146|NCT01325493|"~     The purpose of this study is to:~      1. Establish whether ketamine can decrease opioid consumption and modulate the onset of~     opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10~     years to 18 years, undergoing posterior spinal fusion and instrumentation.~   "
132147|NCT01325480|"~     The purpose of this acute study is to perform a preliminary investigation of high septal~     right ventricular pacing in the vicinity of the His bundle region as an alternate or~     adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.~   "
132148|NCT01325467|"~     This will be a registry study that will enroll patients referred for an ECG treadmill test~     with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information~     will be recorded and analyzed automatically and simultaneous with the standard ECG signals~     by the HyperQ System. Results of subsequent tests performed on each patient will be~     collected and used to enhance the reliability of designating each patient as a CAD-negative~     (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary~     artery disease).~   "
132149|NCT01325454|"~     Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid~     loculation is common in parapneumonic effusion and is associated with depressed pleural~     fibrinolytic activity and poor clinical outcome. However, the relationship between~     angiogenic cytokines and fibrinolytic activity in the pleural space remains unclear. The~     researchers's hypothesis is that the levels of angiogenic cytokines were increased and~     associated with decreased fibrinolytic activity in parapneumonic effusions which may~     contribute to fibrin deposition and fluid loculation in the pleural space.~   "
132150|NCT01325441|"~     This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608~     in combination with paclitaxel in patients with advanced malignancies.~   "
132151|NCT01325428|"~     The general aim of this study is to investigate the efficacy and safety of afatinib alone~     and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy~     within this trial) as treatment in patients with HER2-overexpressing, locally advanced or~     metastatic inflammatory breast cancer. The study will include patients who have and have not~     failed prior trastuzumab treatment.~   "
132152|NCT01325415|"~     The purpose of this study is to evaluate the effects on QTc interval in healthy males when~     administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a~     specific time interval that can be measured in a heart beat by taking Electrocardiogram~     (ECG))~   "
132153|NCT01325402|"~     In this study different mass of the radioligand AZD4694 will be given to patients with~     Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the~     best opportunities for following disease progress and treatment effects.~   "
132154|NCT01325389|"~     Menopause is the milestone of a more broaden condition that can last up to 10 years. The~     first menopausal symptoms usually appear around the age of 42 and are characterized by a~     gradual decline in thyroid and gonadal function with a progressive increase of plasmatic~     luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.~      Recent studies have shown that myo-inositol and melatonin play a major role in ovarian~     homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin~     supplementation lead to an increase of oocyte quality.~      Additional studies focused on postmenopausal women have shown that myo-inositol is able to~     ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk~     of cardiovascular diseases (CVDs).~      The aim of the present study is to evaluate whether myo-inositol and melatonin might play a~     positive role in regulating hormonal levels during menopausal onset.~   "
132156|NCT01325363|"~     The aim of this research is to investigate the neurolinguistic mechanisms underlying thought~     disorders among schizophrenic patients. In particular, it will investigate the~     neurolinguistic basis for loose association - a phenomena which this population is~     characterized by. Several researchers have previously suggested that loose associations~     among schizophrenic patients relate to a lack of inhibition in the automatic spread of~     activation mechanisms within semantic networks (e.g., Soriano, Jimenez, Roman, & Bajo,~     2008). This research focuses on the relationship between I. the left-right hemisphere~     dynamic and II. semantic processing, among schizophrenic patients. The research follows~     Jung-Beeman's (2005) model which relates semantic associations, activation and inhibition~     processes to the functioning of the two cerebral hemispheres.~      Previous research suggests that, when compared to the neurotypical population, people with~     schizophrenia show a less defined - or even reversed - hemispheric lateralization pattern~     for semantic processing. This is linked to an impairment in language function in the left~     hemisphere, and to a language functions shift from left to right hemisphere (e.g., Crow,~     1997). The investigators assume that this unique lateralization pattern may cause a change~     in balance in the semantic activation and inhibition system among schizophrenic patients.~      As stated, one of the linguistic models that predicts how reduced left hemisphere dominancy~     will influence linguistic functioning is Jung-Beeman's (2005) bilateral model for language~     understanding. According to this model, the left hemisphere specializes in precise and fine~     semantic processing, while the right hemisphere specializes in coarse and abstract semantic~     processing. Building upon this distinction, our assumption is that schizophrenic patients~     experience a difficulty in fine semantic processing which is caused by functional impairment~     in the left hemisphere. It is our further assumption that coarse semantic processing -~     located in the right hemisphere - is relatively unimpaired. This change in the balance~     between the two processes may have direct implications on the associative semantic network~     among schizophrenic patients.~      In order to test this hypothesis, the current research will make use of a specific language~     expression type which involves fine and coarse semantic processing, and for which there is~     evidence for crucial right hemisphere involvement: novel metaphor processing. 10-20 adult~     schizophrenic patients will be presented with four different types of two word expressions:~     literal; conventional metaphor; novel metaphor and unrelated. The patients will have to~     decide as quickly and accurately as possible if the expression is meaningful or meaningless~     while their brain activity is recorded by a Magnetoencephalographic (MEG) device (which~     combines a high temporal resolution with the ability to localize the activity).~      Therefore, our main hypothesis is that schizophrenic patients will show a bilateral brain~     activity pattern when conducting semantic decisions, and that this pattern will be related~     to improved reaction times and accuracy when presented with novel metaphors than when~     presented with other types of expressions.~   "
132157|NCT01325350|"~     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared~     with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern~     hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil~     2% solution which will be provided open-label.~   "
132158|NCT01325337|"~     This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared~     with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic~     alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil~     5% solution which will be provided open-label.~   "
132159|NCT01325324|"~     In different cases intraocular pressure (IOP) have to measured in lying position. Therefore~     a lot of portable tonometers have been established. The Icare Pro is a new tonometer on the~     market that allows faster and more comfortable IOP-measurements. No local anesthesia is~     needed, what is a major advantage for the patients. In this study the investigators want to~     evaluate if IOP measurements with Icare Pro Tonometer are as reliable as they are with other~     established portable tonometers (Perkins, TONO-Pen and hand held-Dynamic Contour Tonometer).~        -  Trial with medical device~   "
132160|NCT01325311|"~     This randomized phase II trial studies cholecalciferol and genistein compared to placebo in~     treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow~     the growth of cancer cells and may be an effective treatment for prostate cancer.~   "
132161|NCT01325298|"~     The primary objective of this study is to evaluate two different ultraviolet (UV) dosing~     regimens for corneal collagen cross linking to slow the progressive changes in corneal~     curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.~   "
132162|NCT01325285|"~     The purpose of this study is to determine how intraocular pressure responds to changes in~     the levels of carbon dioxide or oxygen that a healthy individual inspires.~   "
132163|NCT01325272|"~     To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and~     preterm infants who had transient otoacoustic emissions and verify if the presence of~     response is related to gestational age, gender or risk factors for hearing loss.~   "
132164|NCT01325259|"~     Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a~     major matter of concern. There is now an important body of literature stating that early~     isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing~     AD. Several biomarkers are now available : specific and sensitive neuropsychological~     assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI,~     cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain~     glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging~     using labelled compounds specifically binding to APs has been suggested to improve the~     diagnostic reliability and to potentially help in shortening the delay until formal clinical~     diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to~     15 minutes acquisition 50 to 60 minutes post injection.~      Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD,~     MCI patients and Healthy Controls.~      Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will~     have convert toward dementia versus those who will not, at two year follow-up period, to~     compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG~     hypometabolism, ApoE genotype.~      Method: Prospective multicentric study. 65 patients expected to enter the study.~      Primary outcome measure: Standard Uptake Volume ratios.~   "
132165|NCT01325246|"~     The risk for recurrence after ventral hernia repair is often based on reoperation rates with~     short follow-up rather than recurrences identified by clinical examinations.~      The purpose of current study is find the real incidence of recurrences 3 years after ventral~     hernia repair and to compare with the reoperation rate.~   "
132166|NCT01325233|"~     Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of~     studies have shown that AM can reduce cerebral infarction area and has anti-oxidation~     activity. PG2, a sterile powder of polysaccharides isolated from the root of astragulus~     (Huang-Chi) for intravenous injection, has been approved as a botanical drug by TFDA.~     Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase~     intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present~     study was to investigate the efficacy of PG2 on hemorrhagic stroke.~   "
132167|NCT01325220|"~     There will be four study periods: Screening (up to 14 days in length), the Treatment Period~     (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects~     will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg~     three times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be~     performed periodically~   "
132333|NCT01323036|"~     The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the~     blood following consumption of krill oil compared with fish oil and placebo.~   "
132169|NCT01325194|"~     The purpose is to test whether early central nervous system (CNS) prophylaxis given at the~     beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is~     feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses~     high dose methotrexate (HD-MTX) in combination with~     rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four~     courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients~     will receive three courses of liposomal cytarabine intrathecally. The results will be~     compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of~     the therapy offers a potential to overcome the subclinical disease and thus reduce the risk~     of early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for~     detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be~     incorporated into the staging procedures.~   "
132170|NCT01325181|"~     The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab~     injection versus low-fluence PDT in the treatment of chronic CSC.~   "
132171|NCT01325168|"~     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the~     hypothalamus - is a key mediator of complex social and affective behaviors, including~     emotional empathy. Recently, several theoretical studies suggested that PTSD patients have~     abnormal functioning of the OT system. According to these theories, dysfunction in the~     oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and~     therefore intranasal OT may potentially relieve these symptoms. The main goal of this study~     is to examine the effects of administration of nasal OT on empathic abilities among PTSD~     patients. Another goal of this study is to examine the relationship between empathic~     abilities and the ability to retrieve autobiographical memories among PTSD patients.~   "
132172|NCT01325155|"~     The association between exposure to ambient air pollution and pulmonary disease has been~     well established.To date no study has assessed the burden of cardiovascular disease in~     Israel and its relation to ambient air pollution.~      The Haifa Bay Area has a long history of industrialization including possessing the nation's~     largest oil refineries, oil-fired power plant, agrochemical and cement producers, industrial~     incinerators and the Eastern Mediterranean's busiest port. The presence of industrial and~     mobile sources, combined with a basin effect has contributed to air pollution in the Haifa~     Bay Area and has raised concerns about potential health effects.~      Research Objectives~        -  Determine if the increased rate of cardiovascular mortality in Haifa is associated with~          PM 2.5 concentrations.~        -  Assess effect modification in diverse sub-populations.~        -  If an association does exist, assess the economic burden of PM 2.5 associated~          cardiovascular morbidity and mortality.~        -  Design prediction models of daily cardiovascular emergency department visits based on~          daily and seasonal variation of air pollution.~   "
132173|NCT01325142|"~     This study seeks to identify risk factors associated with the development of a jaw condition~     seen in patients with cancer treated with certain medications.~   "
132174|NCT01325129|"~     Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a~     Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic~     Stable Intramedullary Nailing.~      The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and~     MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and~     Patients`satisfaction (CSS-8). Further on, all complications and problems will be~     documented.~   "
132175|NCT01325116|"~     ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack~     constituting approximately 30% of all cases. Clinical guidelines around the world support~     the prolonged use of secondary preventative medications including aspirin, clopidogrel,~     statin, beta-blocker and angiotensin blockers with the highest recommendations. While~     in-hospital and discharge prescription rates are excellent, adherence to these essential~     life-saving medications is far less than ideal, even a few months following hospital~     discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI~     project already underway in LHIN IV to undertake a randomized controlled trial evaluating a~     reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5,~     8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications~     and urging long-term adherence to secondary preventative cardiac medications. This will be~     sent to the family physician and the patient, using audience-appropriate language. If the~     DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and~     effective, then this simple and low-cost intervention will be studied in all patients with~     an abnormal coronary angiogram.~   "
132176|NCT01325103|"~     This research investigates the use of autologous bone marrow stem cells in patients with~     spinal cord injury.~   "
132177|NCT01325090|"~     Botulinum toxin type A has been reported to inhibit the release of various pain~     neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process~     that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This~     action is probably responsible for the analgesic effect of botulinum toxin type A recently~     demonstrated in patients with neuropathic pain of peripheral origin.In those studies,~     patients had been suffering for years. The investigators can hypothesizes that earlier~     administration of Botox in the course of neuropathic pain might prevent central~     sensitization, that is secondary to peripheral sensitization. The investigators can hope to~     increase efficacy of Botulinum toxin type A injections and to prevent chronification of~     pain.~   "
132178|NCT01325077|"~     Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain~     in pediatric patients?~   "
132202|NCT01324765|"~     The goal of the study is to evaluate the efficacy of a two therapeutic models designed to~     enhance women's skills for managing reactive emotions in their current lives as well as to~     educate them about how using these skills can enhance their personal effectiveness and help~     them to gain control of post-traumatic stress reactions. The interventions adaptations of a~     manualized psychotherapy that has shown promise with adults with complex Posttraumatic~     Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET)~     compared to a supportive group therapy (SGT) that has been found to have modest benefits~     with women survivors of childhood abuse (Wallis, 2002).~   "
132203|NCT01324752|"~     The purpose of this study is to determine if Losartan potassium is affected by PA21.~   "
132179|NCT01325064|"~     Background: The purpose of this study is to analyze the relationship between central and~     peripheral blood pressure (clinic and ambulatory) with vascular structure and function,~     assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave~     velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without~     diabetes type 2. Develop and validate a software to measure the retinal vessels and to~     estimate arterio-venous index automatically.~      Methods/design: The investigators will Perform a coss-sectional study with control group,~     with follow-up of 4 years in primary care. The study population will be diabetic type 2~     patients with a control group without diabetes mellitus. The investigators will include by~     consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular~     disease, half of each group. Main measurements: age, sex, height, weight and waist~     circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin,~     fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood~     pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess~     arterio-venous ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and~     morphology analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.~      Discussion: The investigators provide information regarding various parameters derived from~     MAPA and pulse wave analysis of with target organ damage, especially with the vascular~     structure and function assessed by IMT and PWV and endothelial dysfunction in patients with~     diabetes type 2 and without this disease. The investigators also hope to demonstrate the~     usefulness of the tool developed for automatic evaluation of retinal vascularization in the~     early detection of abnormalities of vascular structure and function and the prognosis of~     cardiovascular disease in the medium term.~   "
132180|NCT01325051|"~     The purpose of this study is to characterize the way the first commercially available~     integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV,~     is distributed into the rectal mucosal tissue. This information will generate important~     information regarding the drug's penetration into lymphoid tissues that are rapidly depleted~     in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for~     treating HIV-infected individuals will be designed.~   "
132181|NCT01325038|"~     Healthy males are randomized to isometric exercise for three months with either extra~     protein or extra calories in the form of a fast food meal/day in order to study if increase~     in muscle mass increases resting metabolic rate and if this is affected by presumed~     increased caloric intake as compared with only proteins.~      Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was~     measured by registration of CO2 production and O2 consumption.~   "
132182|NCT01325025|"~     High-field MRI and diffusion tensor imaging with 3D reconstruction of the myelin tracks, in~     combination with multivoxel proton spectroscopy, will allow to precise more accurately the~     evolution of the white matter lesions in patients affected with Metachromatic Leukodystrophy~     (particularly in the initial phase of the disease). This will increase the knowledge of the~     disease and provide new indicators for the selection and evaluation of patients eligible for~     new therapeutic approaches.~   "
132183|NCT01325012|"~     To determine the relationship between perineural catheter location along the sciatic nerve~     (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided~     continuous sciatic nerve blocks.~   "
132184|NCT01324999|"~     This study is designed to assess the efficacy and safety of tadalafil in patients with~     Sarcoidosis Associated Pulmonary Hypertension.~      Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients~     with Sarcoidosis~   "
132185|NCT01324986|"~     Available data regarding the effectiveness of laparoscopic antireflux surgery on~     extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly~     controversial. The aim of the present study was to evaluate the clinical effect of partial~     and total fundoplication on extraesophageal symptoms in a selected cohort of patients with~     GERD.~   "
132186|NCT01324973|"~     Obesity and physical inactivity have become serious problems for individuals with mental~     illness, resulting in increased rates of chronic disease, premature death, and substantial~     health care costs. Although in-person psychoeducational interventions help individuals with~     mental illness manage their weight, these interventions are often not used because they~     require frequent travel to treatment programs and substantial time from clinicians. This~     project addresses these barriers by developing and evaluating the effectiveness of an~     web-based computer system that is focused on diet and exercise education, and designed to~     help individuals with mental illness manage their weight.~   "
132187|NCT01324960|"~     A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and~     tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS)~     who achieved a hematological response after 6 cycles of azacitidine. After approval by an~     independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an~     open label randomized phase II study designed to characterize the efficacy, safety, and~     tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher~     risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of~     azacitidine.~   "
132188|NCT01324947|"~     The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy~     in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in~     study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone~     due to disease progression.~   "
132189|NCT01324934|"~     The main objective of the study is the assessment of the overall graft rejection rate~     (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in~     addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without~     corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids~     during the first year after renal transplantation.~   "
132190|NCT01324921|"~     To compare the postprandial glycemic and insulinemic response of subjects with type 2~     diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance~     test (MTT).~   "
132191|NCT01324908|"~     This clinical trial studies biomarkers in predicting response in patients with~     graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats~     the patient's blood with ultraviolet light outside the body and kills the white blood cells~     before returning blood back into the patient's body. Studying samples of blood from patients~     with GVHD may help doctors identify and learn more about biomarkers related to GVHD.~   "
132192|NCT01324895|"~     The objective of this study is to compare the efficacy of prokinetics versus antibiotics~     versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal~     Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath~     Test.~      Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular~     octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy~     given alone.~   "
132193|NCT01324882|"~     This research study is about determining how well a Technically Improved Colonoscope from~     Olympus works in helping the doctor in guiding the scope through the large bowel or colon.~     When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the~     appendix where the small bowel ends and the large bowel begins. There are points during this~     insertion where there are turns in the colon which can create a loop in the colonoscope.~     These loops can stretch the colon and create some discomfort and also require special~     maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the~     looping will make it more comfortable for the patient and more efficient for screening for~     polyps. The purpose of the study is to examine this colonoscope and compare it to the~     traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this~     colonoscope will function better with regard to insertion of the scope from the rectum to~     the cecum.~   "
132194|NCT01324869|"~     This study is designed to access the safety and efficacy of multiple injections of KH902 in~     patients with Diabetic Macular Edema (DME).~   "
132195|NCT01324856|"~     Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign~     disease of the pancreas and periampullariy region. During the recent years, mortality rate~     of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this~     procedure still carries considerable morbidity up to 40%, depending of definition of~     complications. Pancreatic fistula remains a common complication and the main cause of other~     morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method~     of reconstruction after pancreaticoduodenectomy. Several technique modifications such as~     placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct~     occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease~     pancreatic fistula rate. Since, some retrospective studies showed better results with some~     technique, several meta-analyses did not show any advantage of those various modifications.~     It was shown that the higher risk of pancreatic fistula was noticed in patients with soft~     residual pancreas and small diameter of pancreatic duct. There is only one randomized study~     in the literature dealing with this problem. This study did not reveal any significant~     differences between PG and PJ in patients with soft pancreas and small duct. In order to~     investigate once more this important issue, the researchers conducted randomized multicenter~     controlled trial.~   "
132196|NCT01324843|"~     Background:~      - Researchers are investigating the use of DNA vaccines to treat various types of cancer by~     provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal~     vaccines given to prevent infectious diseases, but they have been less effective than~     anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are~     studying alternate delivery methods, such as the investigational Derma Vax(Trademark)~     injection system that delivers the vaccine into the skin. However, because the Derma~     Vax(Trademark) system has not been studied in humans, more research is needed to determine~     whether this new vaccine delivery method is safe and tolerable, particularly in terms of~     pain levels and skin reactions.~      Objectives:~      - To evaluate the safety, effectiveness, and relative pain levels of intradermal~     electroporation using Derma Vax(Trademark) administered after pretreatment with either a~     topical cream anesthetic or placebo cream.~      Eligibility:~      - Healthy individuals between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and an electrocardiogram.~        -  Participants will have two different creams applied to their upper arms: one cream will~          be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion.~          Each arm will receive a different cream.~        -  Once the cream has taken effect, participants will receive Derma Vax(Trademark)~          treatment. No actual medication will be given during the injection; participants will~          evaluate their reaction based on the pressure and needle stick alone.~        -  Immediately after the treatment, participants will use the Visual Analogue Scale of~          pain intensity to provide a description of the level of pain experienced during the~          injection.~        -  Participants will complete additional questionnaires about pain intensity and will have~          the injected skin site inspected to determine possible reactions to the injection. They~          will also be asked their opinions on whether (based on pain levels) a series of Derma~          Vax(Trademark) treatments would be acceptable for treatment of a serious illness.~        -  The day after the injection, participants will return for an additional skin assessment~          of the treated areas.~   "
132197|NCT01324830|"~     The aim of the Phase Ia (dose escalation) part of this trial is to assess the MTD of BI~     847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part~     of the trial, the aim is to further evaluate the safety profile of BI 847325 at the~     recommended dose and schedule and to assess target modulation and the potential antitumour~     efficacy in patients with selected tumour types.~   "
132198|NCT01324817|"~     The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and~     the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without~     wires and without touching the body.~   "
132199|NCT01324804|"~     The negative effect of internal mammary harvesting on sternal perfusion is well known,~     especially in diabetic subjects. Microdialysis previously showed increased lactate tissue~     concentration after mammary artery preparation. Although high antibiotic concentration is of~     utmost importance in this region, no study previously measured the effect of internal~     mammary artery harvesting on target tissue antibiotic concentration.~      Study hypothesis:~      Internal mammary artery harvesting imposes an additional risk for deep sternal wound~     infection by impairing antibiotic tissue penetration. This effect is mediated by altered~     perfusion patterns and may be seen in cephalosporin and/or Teicoplanin treatment.~      Study objective:~      To evaluate the impact of left internal mammary artery preparation on target tissue~     antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery~      Design:~      This study is designed as an observational pharmacokinetic trial. Patients are their own~     controls by measuring antibiotic concentration in different subcutaneous tissues.~      Study population:~      Patients referred for coronary artery bypass grafting to the Department of Cardiothoracic~     Surgery with planned unilateral left internal mammary artery preparation and a high risk~     profile for deep sternal wound infections will be asked to participate in this trial.~   "
132200|NCT01324791|"~     Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a~     safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms~     of GERD. This prospective randomized study compares objective and subjective outcome~     parameters of Plicator with that of LARS.~   "
132201|NCT01324778|"~     To compare marginal bone level alterations, implant stability and implant survival between~     OsseoSpeed och OsseoSpeed TX~   "
132222|NCT01324505|"~     This clinical trial is conducted in Europe. The purpose of the trial is to investigate the~     influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the~     body) of an oral contraceptive combination drug after multiple administration of semaglutide~     in female subjects with type 2 diabetes.~   "
132223|NCT01324492|"~     The present study is designed to collect safety/tolerability data and explore the efficacy~     of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.~   "
132204|NCT01324739|"~     Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in~     response to myocyte stretching and serves as a reliable biomarker in the diagnosis of~     cardiac dysfunction and heart failure. Recent observations speak for a distinct connection~     between chronic heart failure and diabetes mellitus.~      Objective: The study was set out to investigate the role of BNP on parameters of glucose~     metabolism in a placebo controlled cross-over study in healthy volunteers.~      Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2~     mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after~     beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg~     glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C~     peptide were frequently measured. BNP increased the initial glucose distribution volume~     (13±1 %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration~     (P<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a~     reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no~     impact on beta cell function, insulin clearance or insulin sensitivity.~      Discussion: Intravenous administration of BNP increases glucose initial distribution volume~     and lowers plasma glucose concentrations after a glucose load without affecting beta cell~     function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic,~     but improves the metabolic status in patients with heart failure. This opens new questions~     regarding BNP induced differences in glucose availability and signalling in several~     organs/tissues.~   "
132205|NCT01324726|"~     There has been a great increase in the incidence of infections caused by bacteria that are~     resistant to antibiotic agents. Many of these infections result in worse outcomes of~     patients and increased costs to the healthcare system. The study aims to survey two germs~     that are resistant to a wide range of antibiotics used today. The investigators are~     particularly interested in studying the potential to stop the spread and prevent outbreaks~     of these germs through contact isolation of patients affected by these germs. Patients will~     be included in the study if they have an antibiotic resistant infection caused by any of the~     2 bacteria: E. coli and K. pneumoniae. The research team will then perform rectal, skin~     (armpit, groin, umbilicus), throat, urine, and, if applicable, wound cultures to determine~     other sites where the germ may be present but not causing an infection. The study~     coordinator will furthermore examine the patient's medical record and conduct a short~     interview in order to evaluate specific information about the bacteria that have been~     recovered. This research does not involve any interventions beyond collection of specimens~     and there are no added risks to the patients from the conduction of the study. Neither will~     there be a benefit at the patient level. The benefit will be at the level of the patient~     population, i.e. at a larger scale once the information collected is analyzed. Only the~     principal investigator and study coordinators will have access to all patient-specific~     information. Once all information is collected, all patient identifiers, such as name and~     medical record number, will be deleted.~   "
132206|NCT01324713|"~     Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the~     current gold standard for osteoporosis diagnosis and therapy monitoring. Like all~     quantitative tests, there is some variability in BMD results obtained when scanning a person~     more than once. As such, it is current clinical practice, based on the recommendation of the~     International Society for Clinical Densitometry, that each technologist perform a precision~     assessment. This approach consists of scanning 30 people twice; the data from which allow~     determination of what constitutes a real difference in BMD with 95% confidence. A precision~     assessment typically evaluates a specific clinic's population, using the age range and~     genders seen at that clinic. However men generally have larger, but often more arthritic,~     bones than women which may impact the precision results. Therefore, it is possible that~     gender-specific precision values should be used in clinical practice, however this issue has~     never been investigated.~   "
132207|NCT01324700|"~     Asthma is common with an increasing prevalence and mortality especially in low-income and~     minority populations. The course of asthma appears to be influenced by mood and emotions. It~     has been reported that there is a high prevalence of depression or depressive symptoms in~     both children and adults with asthma. Despite data on the frequency of depression in asthma~     and its adverse consequences, it is generally not recognized or treated. Brown et al.~     conducted a randomized, double-blind, placebo-controlled trial of citalopram in 90~     outpatients with asthma and MDD. Citalopram therapy was associated with lower depression~     scores, numerically greater rates of remission of depressive symptoms, and less oral~     corticosteroid use than placebo. The investigators proposed study is different. The~     investigators observed a modest difference between antidepressant and placebo in the prior~     trial. However, in a subgroup with more severe asthma (based on frequent corticosteroid use)~     and more severe depression (based on higher depressive symptoms scores) the investigators~     saw a much larger effect size. Standard of care for severe asthma is aggressive asthma~     treatment. The investigators study does not require any changes in the patient's asthma~     treatment. No guidelines are currently available on the treatment of depression in asthma~     patients. Standard care for depression would be antidepressants.~   "
132208|NCT01324687|"~     The system of medical care for older adults with acute illnesses often serves them poorly.~     Many factors limit these patients' access to safe, patient-centered, efficient,~     high-quality, acute care. These factors include a shortage of geriatricians and primary care~     physicians; limited availability of timely, acute-illness, patient appointments; emergency~     department (ED) crowding; interruptions to the continuity of care when patients use the ED;~     and poor transitions of care from the ambulatory setting to the ED. These conditions foster~     unnecessary ED use, adverse events in the ED for which older adults are particularly~     at-risk, and unnecessary medical costs. As the population ages, the magnitude of these~     problems will only increase.~      The overarching study goals are to develop and evaluate a telemedicine-enhanced care model~     that improves access to safe, high-quality, acute illness care for older adults; fosters~     appropriate use of health services; and reduces unnecessary expenditures. Specifically, this~     study aims to:~        1. Expand the existing pediatric HeA telemedicine network to older adults by providing~          senior living communities (SLC) with an alternative on-site care option for individuals~          with an acute illness episode.~           Hypothesis 1: 90% of requested telemedicine visits will be successfully completed.~        2. Evaluate the impact of the HeA telemedicine model on utilization, quality of care, and~          patient safety.~           Hypothesis 2: The rate of ED use will be lower at SLCs with access to care via~          telemedicine, as compared to SLCs without such access to care.~           Hypothesis 3: Quality of care and patient safety measures will be better for SLC~          residents with access to telemedicine-enhanced care than for residents without this~          form of access.~        3. Evaluate the economic benefit of the care delivered through the telemedicine network.~           Hypothesis 4: The net cost of healthcare per patient-month will be less for SLC~          residents with access to telemedicine-enhanced care than for those without this form of~          access.~        4. Use qualitative methods to identify strategies and assets that promote and conditions~          that impede the implementation, acceptance, and success of the HeA telemedicine network~          in SLCs. This knowledge will inform efforts to develop a toolkit to be used to~          disseminate this technology broadly.~   "
132209|NCT01324674|"~     The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric~     symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating,~     forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic~     complaints, etc. The CMD has a big social impact, and its prevalence in the general~     population is 25% and graduate students in health care reaches 40%. The Bach´s Flower~     Remedies are considered a complementary therapy approved and recommended by World Health~     Organization and by the Brazilian Ministry of Health and in his theory it has great~     spiritual nature. In addition, international scientific research have suggested that the~     strengthening of spiritual well-being can help significantly and positively promoting mental~     health. This project aims to assess the relationship between treatment with Bach´s Flower~     Remedies and Spiritual well-being of people with Common Mental Disorders in undergraduate~     health students of a university located in São José dos Campos, state of São Paulo, Brazil.~     This research presents a quantitative and qualitative methodology, experimental clinical~     trial, triple blind. The treatment will take place with two groups of forty people, the~     group of treatment and the placebo´s. The trial will happen in six sessions at intervals of~     30 days, totaling eight months of treatment. Statistical analysis will be used chi-square or~     Fisher exact test to study the association between the scale of spiritual well-being and the~     use of Bach Flowers for each time point (3 times). To compare the evolution of the results~     (scales) during the study will set a model for ordinal data with repeated measurements over~     time. For these statistical tests is assumed a significance level of 5% (p < 0.005).~   "
132210|NCT01324661|"~     This study examines youth's motivation for food or social rewards after a brief episode of~     simulated ostracism. The investigators hypothesize that youth who think about a friend after~     being ostracized will mediate their decision to resort to food, which is typically evidenced~     in socially isolated overweight youth.~   "
132211|NCT01324648|"~     Lifetime prevalence rates of Major Depressive Disorder (MDD) in Canada are between 10-12%~     with approximately 1.5 million Canadians reporting depression in any given year. Alarmingly,~     the burden of ill health associated with MDD is projected to increase worldwide such that by~     the year 2020, depression will move from its current position of fourth to become the second~     greatest burden of ill health, closely following ischaemic heart disease (Murray & Lopez,~     1998). As depressed patients are often in frequent contact with their primary care~     physicians for other health problems, effective depression treatment and management~     currently relies heavily on the primary care sector. Cognitive behavioural therapy (CBT) is~     an empirically supported psychotherapy that is recommended by the Canadian Network for Mood~     and Anxiety Treatments Clinical Guidelines as a first-line treatment for depression.~     However, across Canada, CBT is not readily accessible by primary care physicians for their~     patients, particularly in rural areas.~      To help address this nationwide need for CBT, British Columbia (BC) is the first and only~     province in Canada to develop and implement a high capacity mental health service, Bounce~     Back: Reclaim your Health (BB), for primary care patients with mild to moderate depression.~     In BB, the patients' use of Cognitive-Behavioural Therapy (CBT) self-help materials is~     supported via trained telephone coaches.~      The primary objective of our proposed research is to provide direct evidence of the~     effectiveness of the BB program, and, in particular, the telephone coaching component. The~     investigators will test: (1) whether the BB program is more effective than general~     practitioner (GP) treatment-as-usual (TAU); and (2) whether BB's positive results can be~     attributed to the telephone coaching component, as this component is associated with the~     most significant costs of the program. A secondary objective is to assess the~     cost-effectiveness of such telephone support.~   "
132212|NCT01324635|"~     This is an open label phase I clinical trial with two arms, representing single and~     fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is~     pre-determined and not escalated. Panobinostat will be administered orally 3 times a week~     for 2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no~     intra-patient dose escalation.~      Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for~     re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be~     administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation~     therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of~     fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of~     either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2~     weeks, starting on the day of 1st fraction of radiation.~      Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery.~     Panobinostat will be administered orally three times a week for 2 weeks, starting on the day~     of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or~     tomotherapy technology.~   "
132213|NCT01324622|"~     The objective of this study is to compare the clinical and radiographic outcomes of~     multi-level laminectomy to multi-level laminoplasty in the treatment of patients with~     cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the~     laminoplasty group is not inferior to the laminectomy group.~   "
132214|NCT01324609|"~     The purpose of this study is to determine if the investigators can detect the presence of~     choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and~     classification of choroidal nevi and melanomas in the future.~   "
132215|NCT01324596|"~     The aims of this study are:~        -  To evaluate the benefits of the addition of bortezomib to standard rituximab with~          cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse~          Large B-cell Lymphoma (DLBCL).~        -  To determine whether molecular phenotype effects the benefits derived from the addition~          of bortezomib.~   "
132216|NCT01324583|"~     Primary Objective:~        -  To assess the tolerability at global doses~      Secondary Objectives:~        -  Safety~        -  Pharmacokinetics~        -  Efficacy~   "
132217|NCT01324570|"~     The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in~     patients of ages 7 to 16 years.~   "
132218|NCT01324557|"~     The aims of this study are to assess the potential efficacy and safety of insulin pump to~     improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for~     diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.~   "
132219|NCT01324544|"~     The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy~     of intravenous (IV) buprenorphine in pediatric patients.~   "
132220|NCT01324531|"~     The purpose of this prospective, randomized, controlled trial is to compare subjective~     patient-reported outcomes and objective clinical results between arthroscopic Bankart repair~     with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder~     instability with a Hill-Sachs Defect.~   "
132221|NCT01324518|"~     The purpose of this study is to determine whether ORM-12741 is safe and effective in the~     treatment of Alzheimer's disease.~   "
132226|NCT01324453|"~     This study will evaluate change in heart muscle function from baseline to three months and~     twelve months in participants who present with a heart attack and a completely occluded~     coronary artery. These subjects will be randomized to receive standard Percutaneous~     transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine~     PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon~     reperfusion using four cycles of thirty second inflations with a standard angioplasty~     balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that~     Postconditioning reduces the size of the heart attack when utilized with successful primary~     Angioplasty/stent.~   "
132227|NCT01324440|"~     The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of~     the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant~     (MAA).~   "
132228|NCT01324427|"~     Telemedicine is a new area of health care where medical information is transferred through~     audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's~     visits or examinations. This new area of health care is important to test because it can~     potentially provide real-time interactions between the patient and their health care team,~     including phone conversations, online communication, and/or home visits. Many activities~     such as a history review or physical examination can be conducted virtually as compared to~     the traditional face-to face visits.~      The purpose of this study is to determine patient and health care team acceptance of a~     virtual medical visit as a substitute for a face to face visit for patients either~     preparing to receive a stem cell transplant or previously received a stem cell transplant.~   "
132229|NCT01324414|"~     The incidence of Non alcoholic fatty liver disease (NAFLD) continues to increase, and~     prevalence estimates for NAFLD range from 17-33%, making it is the most common cause of~     chronic liver disease in North America. It is associated with increased cardiovascular~     morbidity as well as progression to cirrhosis is a subset of patients. There is currently no~     approved treatment for NAFLD. A key barrier to the development of effective therapies is a~     lack of consensus on the criteria for diagnosis and endpoints for studies evaluating~     diagnostic markers, prognosis and therapeutic modalities.~      NAFLD encompasses an entire pathological spectrum of disease, from relatively benign~     accumulation of lipid (steatosis) to progressive non alcoholic steatohepatitis (NASH)~     associated with inflammation, fibrosis, and necrosis. It has been estimated that 20-30% of~     patients with NAFLD will exhibit biochemical and histological changes characteristic of~     NASH, and 15-20% of those patients will progress to have cirrhosis. NASH remains an~     important phenotypic state, because this sub-group of patients is deemed at high-risk for~     developing progressive disease resulting in cirrhosis, liver failure requiring~     transplantation, or death.~      Although NAFLD has not to date been included as a component of the metabolic syndrome, there~     is increasing evidence that NAFLD frequently accompanies the development of insulin~     resistance and therefore may be an indicator or predictor of future cardiometabolic risk.~     Moreover, recent findings in skeletal muscle of experimental insulin resistance (lipid~     infusion) as well as naturally occurring obese and type 2 diabetic, insulin resistant~     patients show that skeletal muscle inflammation leads to a pattern of extracellular matrix,~     structural, and remodeling abnormalities that closely resemble the TGFb, connective tissue~     growth factor (CTGF) mediated fibrotic response that differentiates simple steatotic liver~     from NASH. This suggests there may be a common underlying mechanism. Given the ready~     availability of skeletal muscle tissue using percutaneous needle muscle biopsies, compared~     to the more invasive liver biopsy, it may be possible to use characteristics of skeletal~     muscle to distinguish the severity of liver fibrosis.~      Given the preponderance of patients being identified with NAFLD, the recognition of less and~     non invasive tests that help to discriminate the different phenotypic types of NAFLD would~     be highly practical and useful. This would help identify patients at risk of progression to~     cirrhosis, and thus make them the target of any available therapeutic interventions.~      The investigators hypothesize that 1. Insulin resistance measured through glucose tolerance~     test directly correlates with the extent of liver and muscle fibrosis, and 2. Inflammation~     and fibrosis in the skeletal muscles correlates with the histopathological changes seen in~     patients with NAFLD, and potentially skeletal muscle inflammation may be used as a~     diagnostic predictor to differentiate patients with NASH from patients with simple~     steatosis.~      The overall goal of this project is to determine the extent to which inflammation and~     fibrosis in skeletal muscle mirrors and is predictive of the level of liver inflammation and~     can distinguish NASH from simple steatosis. Specifically, the investigators propose the~     following Aims:~        1. To use estimates of insulin sensitivity from modeling of oral glucose tolerance tests~          to test the hypothesis that the extent of liver and muscle fibrosis is directly related~          to insulin resistance.~        2. To use liver and muscle biopsies to characterize the changes in abundance of mRNAs and~          proteins that characterize inflammation, extracellular matrix remodeling, and fibrosis.~          The investigators will use quantitative rt-PCR and immunoblot analysis to compare mRNA~          expression and protein abundance of collagens I and III, fibronectin, and connective~          tissue growth factor (CTGF) to test the hypothesis that there is a direct relationship~          between the levels of these proteins in muscle and liver and the degree of fibrosis.~        3. To establish a biospecimen repository of serum, mRNA from circulating white blood~          cells, liver and muscle tissue, and DNA to serve as the substrate for future studies of~          the pathogenesis of NASH.~   "
132230|NCT01324401|"~     Peanut allergy is one of the most serious food allergies because of its life long~     persistence, and the potential for severe allergic reactions. Effective oral immunotherapy~     would benefit patients by reducing the likelihood that they will have life-threatening~     accidental allergic reactions. This research study is being done to develop an effective~     oral immunotherapy treatment for patients with peanut allergy.~   "
132231|NCT01324388|"~     The purpose of this study is twofold:~        1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering~          drug (lisinopril) in participants with high blood pressure who are currently taking~          lisinopril.~        2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy~          volunteers when taken with a Beta-blocker drug (metoprolol).~      In Part 1, participants will receive four weekly injections of LY2189265 with continued use~     of normal lisinopril therapy.~      Part 2 is a cross-over study design. Participants will receive a single injection of~     LY2189265 in one period, and seven daily doses of metoprolol and a single injection of~     LY2189265 in another period.~   "
132232|NCT01324375|"~     In this consecutive, prospective cohort study the investigators evaluate if preoperative~     pain response upon heat stimulation is predictive for acute and subacute postoperative pain~     after total hip arthroplasty.~   "
132233|NCT01324362|"~     The purpose of this study was to determine whether asthma control and reduced bronchial~     responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids~     with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma~   "
132234|NCT01324349|"~     The objective of this study is to evaluate the safety and effectiveness of Covidien's~     Hemostatic Patch to control bleeding during hepatic surgery. The performance of the~     Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic~     techniques.~   "
132235|NCT01324336|"~     The purpose of this study is to compare the pharmacokinetics of a routinely used compounded~     liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in~     patients who are receiving treatment with 6-MP as part of their clinical treatment for acute~     lymphoblastic leukemia (ALL).~   "
132236|NCT01324323|"~     The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin~     on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.~   "
132237|NCT01324310|"~     The purpose of this study is to evaluate the effect and safety of multiple doses of~     ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.~   "
132238|NCT01324297|"~     The purpose of this study is to gather normative data from healthy adults and to determine a~     sensitive and specific cut-off value for responders and non-responders to the Niacin Skin~     Flush Test in a sample of first episode psychosis patients.~   "
132239|NCT01324284|"~     Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel~     preparation can be improved for a good colonoscopic examination without missing lesions and~     complications.~   "
132240|NCT01324271|"~     The objective of the study is to evaluate the safety and efficacy of the Acclarent~     Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under~     local anesthesia in an office/clinic setting.~   "
132241|NCT01324258|"~     This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This~     study is designed to identify recommended doses and regimens in Japanese subjects for the~     future development of GSK1120212.~   "
132242|NCT01324245|"~     The kidney plays a crucial role in maintaining salt balance by two opposing physiological~     mechanisms: the renal dopaminergic system which enhances salt excretion and the~     renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension~     occurs when this balance is altered or abnormal. We hypothesized that this balance is~     influenced by salt intake: therefore dietary salt affects the natriuretic response to the~     renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor,~     Enalapril.~      In this trial we study normal salt balance mechanisms in salt resistant adults with normal~     blood pressure.~   "
132243|NCT01324232|"~     The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3~     doses of AVP-923 capsules in the treatment of central neuropathic pain in patients with~     multiple sclerosis.~   "
132478|NCT01321138|"~     Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block~     may be as high as 24% at 6 postoperative weeks when evaluated prospectively and~     systematically through a clinical neurological and an electroneuromyography (ENMG). It is~     still unclear whether this neuropathy is the result of the surgery, especially the~     Tourniquet, or the block nerve. The goal of this study is to define the etiology of this~     postoperative neuropathy.~   "
132244|NCT01324219|"~     The investigators are interested in reducing problem behaviors of nursing home residents~     with dementia that make providing care difficult. The investigators call these behaviors~     resistiveness to care. Previous research has found that resistiveness to care occurs more~     frequently when staff use certain types of communication. An inservice program will be~     provided to all nursing staff in your nursing home to teach staff about communication~     practices to reduce resistiveness to care. The research study will see whether changing~     communication will reduce resident resistiveness to care. If effective, the communication~     training may then be used to improve care in other facilities.~      By doing this study, researchers hope to learn if changing communication practices will~     reduce resistiveness to care in nursing home residents with dementia.~   "
132245|NCT01324206|"~     Background:~      - Magnetic resonance imaging (MRI) studies provide important information on the structure~     and function of various body systems, including the brain, muscles, joints, heart, and blood~     vessels. Scientific applications of MRI scans often use techniques that need to be modified~     or refined before they are used in clinical studies. To develop and modify these techniques~     for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in~     conducting trial MRI scans on healthy individuals and individuals with conditions that~     require imaging studies.~      Objectives:~      - To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning~     procedures.~      Eligibility:~      - Individuals at least 18 years of age who are able to have magnetic resonance imaging.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests.~        -  Participants will have an MRI scan using the 3T scanner. Some scans may require the use~          of a contrast agent or radiotracer, which is a small amount of radioactive substance~          that will be injected before the start of the scan. Some participants may be asked to~          perform tasks of thinking and movement while in the scanner, in order to test the~          procedures required for a functional MRI scan.~        -  No treatment will be provided as part of this protocol.~   "
132246|NCT01324193|"~     Chronic kidney disease (CKD) patients have very low physical function and high rates of~     cardiovascular disease (CVD) mortality. The objective of the proposed research is to~     evaluate the effects of dietary supplementation with a pomegranate extract, that contains~     high amounts of antioxidants, on physical function and CVD risk. Patients with moderate to~     severe chronic kidney disease that are NOT yet on dialysis tend to have significantly~     reduced risk factors for cardiovascular disease (and other disorders) compared to dialysis~     patients. This includes significantly reduced systemic markers of oxidative stress and~     inflammation. As a result, therapies designed to reduce the risk of CKD co-morbidities may~     differ significantly in dialysis and pre-dialysis patients. For example, dialysis patients~     are recommended to INCREASE their intake of dietary protein, while pre-dialysis patients are~     recommended to DECREASE their protein intake, due to differences in the pathophysiology of~     the two conditions. The investigators have decided to recruit pre-dialysis patients in~     addition to dialysis patients in this study because the investigators believe this will help~     us determine if the efficacy of pomegranate differs between patients with different stages~     of CKD.~   "
132247|NCT01324180|"~     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project~     Coordinator, but will not be recruiting locally.~      The purpose of the trial is to study the clinical and biological effects of metformin in~     combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a~     dismal outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose~     (MTD) of metformin in conjunction with ALL therapy. There have also been analysis of~     patients enrolled on trials who were diabetics on metformin and their outcome was better~     than patients on the same trial that were not on metformin as their antihyperglycemic.~   "
132248|NCT01324167|"~     The investigators would like to know the association of gene polymorphisms and metabolic~     adversities in clozapine-treated patients with schizophrenia in Taiwan.~   "
132249|NCT01324141|"~     Background:~      - Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin~     that can lead to redness and tenderness, and in some cases can be so severe that it results~     in blistering or peeling of the skin during treatment. These conditions cause discomfort and~     may require breaks from radiation treatment. Researchers are interested in determining~     whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be~     given before radiation treatment to prevent these side effects and reduce the irritation of~     the skin during chemotherapy and radiation for anal cancer.~      Objectives:~      - To determine the safety and effectiveness of topical MTS-01 given before radiation in the~     groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal~     and are eligible to receive radiation and chemotherapy treatments.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, imaging studies and physical examination of the anal canal, and biopsies as~          needed to evaluate eligibility for treatment.~        -  Participants will be scheduled for radiation and chemotherapy treatments on the~          following schedule:~        -  Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin~          in the groin areas and between the buttocks before each treatment~        -  Mitomycin C given intravenously on days 1 and 29 of treatment~        -  5-Fluorouracil given intravenously over 4 days (first week and fifth week) during~          radiation treatment~        -  Participants will be monitored throughout the treatment for side effects, with~          photographs of the treatment area and frequent blood tests.~        -  Following the end of radiation, participants will have followup visits for 1 year with~          blood tests and imaging studies to evaluate the response to treatment.~   "
132250|NCT01324128|"~     This is a Phase 3, randomised, active controlled, multicentre study to investigate the~     safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in~     dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering~     phosphate levels in these patients.~   "
132251|NCT01324115|"~     RATIONALE: NG-nitro-L-arginine may stop the growth of tumor cells by disrupting blood flow~     to the tumor.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     NG-nitro-L-arginine in treating patients with advanced solid tumors.~   "
132252|NCT01324102|"~     With advances in the detection and treatment of cancer, there are now 14 million cancer~     survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration.~     The mental and physical health consequences of cancer and its treatment may affect a~     Veteran's functioning and re-integration back into family, work, and daily life. Recent~     studies suggest that yoga may be an effective intervention for improving both the physical~     and mental health of individuals after cancer, although this has not been studied in~     Veterans. This study has three components: (1) Determine factors that increase participation~     in Yoga by Veterans using individual interviews and focus group; (2) Create a Yoga protocol~     for Veterans adapted from an existing empirically supported treatment, akin to a phase 1~     clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving~     fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a~     phase 2 trial with randomization.~   "
132253|NCT01324089|"~     There is some evidence that when resveratrol (a substance which is found in red grapes,~     peanuts and chocolate) is combined with Piperine (a substance found in pepper) it is more~     effective in fighting cancer. The purpose of this study is to see if resveratrol in~     combination with piperine is more effective than taking resveratrol alone. Since~     investigators don't know what dose of piperine to use in combination with resveratrol, two~     different doses of piperine will be studied.~      Twenty-four participants, equal numbers of males and females, will receive a single dose of~     resveratrol (2.5 grams) without piperine, resveratrol (2.5 grams) with piperine (5 mg), or~     resveratrol (2.5 grams) with piperine (25 mg).~   "
132254|NCT01324076|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking~     the blood flow to the tumor. Sorafenib tosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.~     It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads~     is more effective when given with or without sorafenib tosylate in treating patients with~     liver cancer that cannot be removed by surgery.~      PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization~     using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared~     with giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in~     treating patients with liver cancer that cannot be removed by surgery.~   "
132255|NCT01324063|"~     RATIONALE: Patient abstract not available~      PURPOSE: Patient abstract not available~   "
132256|NCT01324050|"~     The overall aim of this study is to develop and test a psychodynamic Internet-delivered~     psychological treatment for patients with mild to moderate major depression and compare its~     efficacy to an active control group.~   "
132257|NCT01324037|"~     Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare~     disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a~     thrombosis, there is a blood clot in one of the veins, which should be treated with blood~     thinners (anticoagulants). The aim of the present study is to see whether it is safe to use~     a combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a~     clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most~     patients also an ultrasound of the arm will be done. The combination of these tests was~     found to be safe and effective in patients with thrombosis of the legs.~   "
132258|NCT01324024|"~     The purpose of this study is to determine whether a medication called Vyvanse®~     (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of~     sustained attention, verbal encoding and recall and working memory, in menopausal aged~     women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD).~     The cognitive difficulties that menopausal women report experiencing are typical of adults~     who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective~     in alleviating those cognitive disruptions when compared to a placebo.~   "
132259|NCT01324011|"~     NOTE: This study is in the trial-phase of a 5-year study that included a formative research~     phase (Phase 1 - IRB study # 07-1765 Family-based Diabetes Self-management Training for~     African American Adults). During the first phase, eight focus groups were conducted with 68~     participants and a validation study with 215 African American patients with type 2 diabetes.~     The data gathered in Phase 1 informs the refinement of the intervention in this phase.~      Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial,~     a family-based diabetes self-management intervention for overweight/obese African American~     adults with type 2 diabetes (the index participants) and a paired overweight family member~     (co-participant) who does not have diabetes. The primary outcome is weight change in the~     index participant.~   "
132260|NCT01323998|"~     This retrospective study aims to assess treatment patterns within 1 year of initiating BPH~     treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB)~     monotherapy, early combination therapy, and delayed combination therapy. The MarketScan~     database will be utilized for this study (2000-2008)~   "
132261|NCT01323985|"~     The purpose of this study is to provide safety information and to define the optimal~     induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in~     healthy volunteers prior to assessing in patients~   "
132262|NCT01323972|"~     The purpose of this study is to show the consistency of different lots of a candidate~     vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.~   "
132263|NCT01323959|"~     This study will evaluate the persistence of immune response against diphtheria, tetanus,~     pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also~     assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.~   "
132264|NCT01323946|"~     The objective of the study is to evaluate the immunogenicity and safety of prime-boost~     vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.~   "
132265|NCT01323933|"~     Analysis of safety, tolerability, and PK data will provide information that will guide~     future development of AB0024.~   "
132266|NCT01323920|"~     A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a~     complication of transplantation where the donor graft attacks and damages some of your~     tissues. After stem cell transplant, all patients receive prophylactic medications against~     GVHD.~      In this research study, we are studying the safety and effectiveness of a bortezomib based~     GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call~     transplantation from a matched unrelated donor, mismatched related or unrelated donor.~   "
132267|NCT01323907|"~     The purpose of the study is to provide use of Omegaven in infants with life threatening~     Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical~     treatments/therapies have been either ineffective or not feasible in the treatment of this~     serious condition. This is a compassionate use protocol.~   "
132268|NCT01323894|"~     The first year purpose:~      The best concentration of canonical Wnt3a will be investigated in promoting the~     osteoblastogenesis of human mesenchymal stem cells.~   "
132909|NCT01315457|"~     The aim of this study is to propose infection prophylaxis from Asian multinational~     retrospective analysis of infectious complications in patients who were treated with~     alemtuzumab~   "
132271|NCT01323855|"~     This is a two part study to compare the PK of preladenant administered to participants with~     CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the~     PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of~     participants with moderate CRI and participants with mild CRI to healthy participants. The~     primary hypotheses are that the plasma area under the concentration-time curve from time 0~     to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe,~     moderate or mild CRI is similar to that of matched healthy participants.~   "
132272|NCT01323842|"~     Renal colic is a common (1300 visits per year at our institution) and painful condition~     caused by stones in the kidney and ureter, and can be mimicked by life threatening~     conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical~     uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency~     physician at the patient's bedside, and has been shown to be accurate, safe, and efficient.~     We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of~     complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated~     clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis,~     and when normal, whether patients can be safely discharged.~   "
132273|NCT01323829|"~     This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for~     Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to~     determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that~     are high tone. Patients who have been diagnosed with high tone pelvic floor muscle~     dysfunction and have failed other treatments will be eligible to participate in this study.~     Study related procedures will include perineometry readings. Patients will be required to~     complete 7 questionnaires for this study. These include visual analog scale (scale from~     0-10) for pain (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires~     (ICSI/ICPI), Pelvic Floor Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale~     (FSDS), Global Response Assessment Scale and the SF-12 quality of life scale. The use of the~     EMG guidance is the experimental part of the study. We will perform EMG Needle testing in~     order to pin-point the best location for the patients Botox injections. This is a~     prospective, pilot, longitudinal study to evaluate the effect of Botox A injection for~     chronic pelvic pain and HTPFD.~   "
132274|NCT01323816|"~     The purpose of this study is to evaluate and compare outcomes of patients that have received~     care in medical intensive care units in a tertiary care facility with two different models;~     the traditional model including resident, pulmonary fellow and attending physician and a~     nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary~     fellow, and an attending.~   "
132275|NCT01323803|"~     This study will establish a registry for participants with eosinophilic esophagitis (EoE)~     and create a research resource that will provide further insights into EoE.~   "
132276|NCT01323790|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~   "
132277|NCT01323764|"~     The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus~     Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt~     function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP)~     shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide~     shunt patency testing (SPS) is required.~   "
132278|NCT01323751|"~     Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as~     monotherapy, and also in combination with bortezomib and dexamethasone in patients with~     relapsed or relapsed/refractory multiple myeloma.~      Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with~     bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple~     myeloma.~   "
132279|NCT01323738|"~     Many people suffering from alcohol dependence have a history of exposure to stressful life~     situations, such as childhood physical or emotional misuse. Often, there's a functional~     relationship between drinking and emotional problems related to past traumatic experiences,~     i.e. drinking to forget. However, alcohol treatment often does not include interventions to~     support patients to cope better with past life experiences. On the other hand, most~     alcoholics are poorly motivated to participate in long-term rehabilitative treatments after~     detoxification. In the proposed study, the investigators will study the effects of a brief~     psycho-educational group intervention during detoxification treatment on motivation to~     change and the willingness to accept further treatment.~      The investigators will use a group comparison design (intervention versus TAS control~     group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific~     information group. In month 2, the information group is replaced by the psychoeducational~     group (intervention). Ward staff selects patients for the groups, irrespective of~     intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive~     impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal~     crisis). The group sessions will take place in groups of up to 15 patients and will include~     4 structured sessions (45 min each). Main content if the intervention group is to highlight~     and discuss the association between stress, Posttraumatic Stress Disorder and drinking.~     Patients will also be informed about the different treatment options available in the~     region.~      At entry, patients are asked to fill in the German versions of the University of Rhode~     Island Change Assessment (URICA; McConnaughy, Prochaska, & Velicer, 1983; German:~     Heidenreich, Hoyer & Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996;~     German: Maercker, 2002). At discharge, patients are asked to fill in the URICA.~      The investigators expect that specific information on the association between stress and~     drinking will increase the patients' motivation to participate in further treatment.~   "
132280|NCT01323725|"~     The purpose of this study is to identify the effectiveness of team-base financial incentives~     for increasing long-term smoking cessation among employees at St. Paul's Hospital, Korea.~   "
132281|NCT01323712|"~     Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from~     diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is~     very common in CKD and associated with CVD. Animal studies have shown an improvement in~     heart size and function with Vitamin D therapy, although evidence in humans is lacking. The~     proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will~     improve heart enlargement and function. With these proposed changes the investigators expect~     to reduce CVD and deaths in patients with CKD.~   "
132282|NCT01323699|"~     Behavioral Treatments for Anxiety and Depression (BehTA-D) is a research study for anxiety~     and depression in individuals with Parkinson's disease (PD). The research clinicians try to~     teach skills that may help participants cope with anxiety and depression in the context of~     Parkinson's disease. Research clinicians will also discuss ways improve management of~     Parkinson's symptoms. Other skills taught include how to relax, change thinking, add in~     meaningful pleasant activity.~   "
132283|NCT01323686|"~     The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead~     placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive~     patients meeting the standard criteria for CRT are included in a prospective,~     double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging~     using echocardiography, single-photon emission computed tomography, and visualization of~     cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an~     epicardial vein at the site of latest mechanical activation without scar tissue or 2) using~     standard LV lead placement.~   "
132284|NCT01323673|"~     The purpose of this study is to determine how clobetasol proprionate foam works against a~     placebo foam in the treatment of hand dermatitis.~   "
132285|NCT01323660|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination~     and component, two-period, incomplete block design cross-over study using~     GSK573719/GW642444. The primary objective is to evaluate lung function and exercise~     endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation~     Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg),~     GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel~     DPI).~   "
132286|NCT01323647|"~     This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged~     18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV)~     in the primary study. The study will also assess the immunogenicity and reactogenicity of a~     booster dose of IPV in subjects primed with three doses of IPV.~   "
132287|NCT01323634|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI~     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily~     over a 12-week treatment period in subjects with COPD.~   "
132288|NCT01323621|"~     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI~     100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily~     over a 12-week treatment period in subjects with COPD.~   "
132289|NCT01323608|"~     The purpose of this pilot study is to determine the effect of various doses of vitamin D~     supplementation on vitamin D stores and calcium excretion in the urine in subjects with~     Thalassemia Major (TM). Subjects with TM are routinely placed on vitamin D supplements~     because they frequently have osteoporosis (a condition in which bone tissue thins and loses~     density and strength) and low vitamin D stores. The amount of vitamin D supplementation that~     is required to raise vitamin D stores in optimal levels is not known in TM, and will be~     determined in this study. Finally, a recent study in TM has linked blood vitamin D levels to~     urine calcium excretion, which is a risk factor for kidney stones. Therefore, we want to~     determine changes in calcium excretion with various vitamin D doses and with increasing~     vitamin D stores. We plan to test 3 doses of vitamin D for 3 months in children and adults~     with TM. Changes in vitamin D blood levels and urinary calcium will be determined. The~     results of this pilot study will be used in future studies that will examine the effect of~     various doses of vitamin D supplementation in the treatment of osteoporosis in TM.~   "
132290|NCT01323595|"~     While narcotic medication are commonly used for pain control near the time of surgery, there~     are significant side effects including constipation, nausea, risk of overdose leading to~     decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives~     to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have~     designed a prospective randomized clinical trial to evaluate how effective the~     anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of~     surgery. Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal~     anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.~      Patients will be divided into two groups: the first group receives a celecoxib pill and the~     second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly~     which pills are given. The patient will complete questionnaires for pain level. By comparing~     the pain levels we can better understand whether celecoxib (Celebrex©) significantly~     decreases perioperative pain.~   "
132291|NCT01323582|"~     Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In~     susceptible patients however, it has been associated with sudden cardiac death due to~     prolongation of QT intervals and subsequent cardiac risks through its interaction some other~     drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf~     interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation~     and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and~     may be preferred as a prokinetic agent in patients on other concomitant medications.~      We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin~     in the treatment of Gastroparesis (GP), and later, form the framework for larger~     randomized-controlled parallel studies to investigate use of AZI for treatment of GP.~      Our novel hypothesis is to determine whether AZI can be used to treat GP.~   "
132292|NCT01323569|"~     This crossover study with six treatment sessions is to evaluate the abuse potential of three~     doses of Sativex as compared to Marinol and placebo, in subjects with a history of~     recreational marijuana use.~   "
132293|NCT01323556|"~     Investigation of mechanisms of exposure based learning by~        1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo~          exposure~        2. Disentangling the effects of interoceptive exposure exercises in panic disorder~   "
132294|NCT01323543|"~     The safety and performance of the Elaspine™ Implant System in the treatment of lower back~     pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing~     clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5~     clinical centres, including in average 10 patients per centre. The study is conducted in~     accordance with the Standard ISO 14155, where applicable on clinical investigation of~     medical devices for human subjects and other legal requirements.~   "
132295|NCT01323530|"~     This is a Phase 1b/2, multi-center, open-label, dose escalation and dose-and-schedule~     confirmation study of eribulin administered in combination with capecitabine.~   "
132479|NCT01321125|"~     The physicians have few options for skin antisepsis. Alternatives for common use antiseptics~     are costly or ineffective. In order to have more options, this study is needed. The~     investigators want to know if there are differences between the use of 2% chlorhexidine~     gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.~   "
132296|NCT01323517|"~     The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab,~     to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is~     an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the~     immune system (the body's natural defense system that helps fight infections) uses to quiet~     an immune response. The study drug works by blocking this protein and allowing the immune~     system to become more active. This study will investigate the effects, of combining ILI~     (using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study~     drug, Ipilimumab on advanced Melanoma cancer.~   "
132297|NCT01323504|"~     It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD),~     of whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation,~     the patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is~     generally associated with increasing pain. Pain relief may be challenging in spite of major~     analgesics.~      Several studies in this country and elsewhere assessed the usefulness of music for chronic~     or acute pain relief during care. However, no data are published regarding the interest of~     music therapy for pain relief during local care in PAD patients.~   "
132298|NCT01323491|"~     The actually most accepted method of effective smoking cessation is based on structured~     consultation and medical care in combination with supportive medical treatment. A group of~     experts developed the concept EINFACH ERFOLGREICH RAUCHFREI (EASY EFFECTIVE SMOKELESS)~     for general practitioners providing a structured compendium for negotiation.~      Physicians who have implemented this concept will conduct this non-interventional study. The~     implementation of the scheme will be investigated under general practice conditions and the~     applicability of the concept has to be assessed by the physicians.~      In addition further knowledge of smoking cessation in would-be non-smokers which decided to~     quit, supported by medical treatment with NICORETTE®-products, will be documented for a~     large patient collective under real practice conditions.~      To answer all above mentioned questions for a sufficient number of patients a multicenter,~     prospective non-interventional study design was used for this trial as only this instrument~     detects characteristics of the physicians' treatment without any further input or other~     influences.~   "
132299|NCT01323478|"~     To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of~     Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)~   "
132300|NCT01323465|"~     Study to assess the effect of rifampicin, ketoconazole and omeprazole on the~     pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when~     given in combination with these other drugs.~   "
132301|NCT01323452|"~     The primary aim of this study is to asses the efficacy (both virological and clinical) and~     safety of ETV in both NA-naïve and NA-experienced chronic hepatitis B patients, and to~     explore baseline factors associated with virologic reponse (VR) to ETV.~   "
132302|NCT01323439|"~     Ten study centers from US are anticipated to participate for this evaluation. Published~     literature on coils with electrolytic, thermal or hydraulic detachment will serve as the~     basis for control comparisons to the Axium™ MicroFX™ Detachable Coil System for patients~     undergoing embolization of intracranial aneurysm. Comparison will be based on criteria~     evaluating the safety of the procedure, the reliability of detachment, the occlusion~     stability and the packing density impact~   "
132303|NCT01323426|"~     This pilot study examines safety and efficacy of a simple procedure for treatment of stress~     urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the~     urethral sphincter.~   "
132304|NCT01323413|"~     The purpose of the study is to examine the influence of demographic, clinical and laboratory~     characteristics on the presence and size of penumbra in acute ischemic stroke patients and~     to determine those of them which related significantly and independently to the presence and~     size of Penumbra. The examined factors will include demographic variables such as age,~     gender, ethnic background, vascular risk factors and medical history, clinical parameters~     such as time from stroke onset until arrival to the hospital, results of neurological~     evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood~     pressure, glucose level, renal functions etc. and imaging findings - the presence and the~     size of collateral blood vessels, the state of carotid arteries (by CTA). The possible~     correlation between all this parameters and the presence and the size of penumbra as~     detected by CTP will be further examined.~   "
132305|NCT01323400|"~     The purpose of this study is to evaluate the antitumor activity of pazopanib in patients~     with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST)~     resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.~   "
132306|NCT01323387|"~     Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative~     disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.~      The primary objective of this study to measure fusion success in patients with lumbar~     degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is~     evaluation of the patient's quality of life, pain and function.~   "
132307|NCT01323374|"~     A correlation between increased norepinephrine concentration in the central nervous system~     (CNS) and a decrease in fibromyalgia pain has been suggested in clinical studies. Therefore,~     as a pro-drug of norepinephrine, droxidopa could potentially benefit fibromyalgia patients~     by reducing pain as a result of increasing CNS levels of norepinephrine.~      As this benefit is presumed to be a central effect, the addition of carbidopa, a peripheral~     DOPA decarboxylase (DDC) inhibitor, may favorably impact the drug's treatment profile.~     Carbidopa is utilized as a blocker of peripheral DDC, an enzyme required for the conversion~     of droxidopa into norepinephrine. Therefore, inhibition of peripheral DDC should result in a~     reduction of any side effects resulting from the peripheral production of norepinephrine,~     whilst allowing for increased central levels, and hence, increased centrally mediated~     benefits.~      The purpose of the study is the obtain information regarding the proper dosing,~     effectiveness and safety of droxidopa and combination droxidopa/carbidopa treatments in~     patients with fibromyalgia.~   "
132308|NCT01323361|"~     The study aims to show variation in CA-125 and other inflammatory markers assumed to be a~     response to trauma and peritoneal inflammation in the perioperative period of laparoscopic~     ventral hernia repair~   "
132936|NCT01315106|"~     The purpose of this study is to determine how well a new MRI technique called High~     resolution 3D diffusion-weighted breast MRI detects breast cancer.~   "
132310|NCT01323335|"~     Background:~      - Uric acid is a substance found in the blood that may contribute to certain chronic medical~     conditions and disorders, such as diabetes, insulin resistance, and high blood pressure.~     High uric acid concentrations have been associated with stroke and heart disease, as well as~     chronic heart failure. In particular, researchers are interested in determining the~     relationship between uric acid and inflammatory markers, or chemicals in the blood that can~     indicate inflammation and other problems with the body.~      Objectives:~        -  To study the specific effects of changes in uric acid in the body.~        -  To determine whether uric acid contributes to inflammation in the body.~      Eligibility:~      - Healthy individuals between 50 and 75 years of age.~      Design:~        -  This study will involve four visits: a screening visit, two study visits, and a~          followup visit.~        -  At the screening visit, participants will have a physical examination, blood and urine~          tests, and an electrocardiogram. Participants will be divided into two groups based on~          the existing amount of uric acid in their blood.~        -  Within 7 days of the screening visit, participants will have a full-day study visit~          with a magnetic resonance imaging scan, followed by a high-fat meal and further blood~          samples collected over the following 8 hours.~        -  At least 2 days after the first study visit, participants will have the second study~          visit, which will require a 2-night stay at the National Institutes of Health.~          Participants will have a metabolism test, and will receive the following infusions~          based on the groups they were assigned to at the screening visit.~        -  Group A (low uric acid) will receive either uric acid or a placebo.~        -  Group B (moderate to high uric acid) will receive either Rasburicase (a drug that~          reduces the amount of uric acid in the blood) or a placebo.~        -  After the infusions and related blood tests, participants will have a high-fat meal~          with further blood and urine samples.~        -  Approximately 2 weeks after the second study visit, participants will have a final~          followup visit with additional blood and urine tests to determine whether the levels of~          uric acid in the blood have returned to normal.~   "
132311|NCT01323322|"~     The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a~     multidisciplinary, community-based, prospective longitudinal epidemiologic study examining~     the influences of race and socioeconomic status (SES) on the development of age-related~     health disparities among socioeconomically diverse African Americans and whites in~     Baltimore. This study investigates whether health disparities develop or persist due to~     differences in SES, differences in race, or their interaction. This study is unique because~     it will assess over a 20-year period physical parameters as well as evaluate genetic,~     biologic, demographic, and psychosocial parameters of African American and white~     participants in higher and lower SES. It also employs novel research tools, mobile medical~     research vehicles, in hopes of improving participation rates and retention among~     non-traditional research participants. The domains of the HANDLS study include: nutrition,~     cognition, biologic biomarkers, body composition and bone quality, physical function and~     performance, sociodemographics, psychosocial, neighborhood environment and cardiovascular~     disease. Utilizing data from these study domains will facilitate understand the driving~     factors behind persistent black-white health disparities in overall longevity,~     cardiovascular disease, and cognitive decline.~      HANDLS Wave 1, the initial recruitment and examination phase that began in August 2004, is~     complete. The current protocol outlines the revisit waves of this study HANDLS Wave, 2~     entitled, The Association of Personality and Socioeconomic status with Health Status An~     Interim Follow-up Study, which began in June 2006 under a separate protocol is designed as a~     telephone interview to occur approximately 18 months after the first visit to the mobile~     Medical Research Vehicles (MRVs). Wave 2 provides interim contact with study participants,~     and important interim information regarding their health. The next visit HANDLS Wave 3 will~     consist of the second visit to the mobile Medical Research Vehicles (MRVs) for a health~     examination to occur at least 3 years after the first, a telephone interview to include the~     dietary interview and questionnaires, and for a random sample of those who participate in~     the revisit a direct measurement of renal function and a brain scan study using M RI to~     examine the structure of the brain.~   "
132312|NCT01323309|"~     The aim of the study is to compare the benefits of three types of individual treatment~     programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and~     Enhanced Usual Care.~      We would like to train therapists in administering these types of counseling, so that they~     have expertise to work on the study. The therapists will administer either the~     Meaning-Centered counseling or the Supportive counseling, as part of their training.~      Many cancer patients use counseling or other resources to help with the emotional burden of~     their illnesses. Counseling often helps them cope with cancer by giving them a place to~     express their feelings. Meaning-Centered counseling aims to teach cancer patients how to~     maintain or even increase a sense of meaning and purpose in their lives, despite cancer.~     Supportive counseling is intended to help the patient cope with cancer by giving them a~     place to express their feelings and get support. Enhanced Usual Care is intended to offer~     the patient referrals and resources that are matched to their individual needs in addition~     to the care they are already receiving at MSKCC.~   "
132313|NCT01323296|"~     The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered~     intravenously allows an area of heart muscle damage after heart attack to be visualised~     using a magnetic resonance scanner.~   "
132314|NCT01323283|"~     This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase~     physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally~     active 8 year old children. The purpose is secondarily to explore patterns of associations~     between OM3 supplementation, baseline and follow-up levels in all studied parameters. The~     study also aims to study if basal levels of OM3 are correlated with physical activity and to~     study if there is an association between basal levels of OM3 and the effect of OM3~     supplementation on physical activity. To study if there is an effect of OM3 supplementation~     on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects~     on children with higher levels. To study if OM3 supplementation, compared with placebo~     reduce weight increase among children at risk to become overweight. To study if there is an~     association between effects of OM3 on physical activity, weight and risk markers in blood.~     To study if there are any gender differences.~   "
132315|NCT01323270|"~     This study is to look at a new vaccine that might prevent meningococcal disease, and to look~     at the safety of the new vaccine as well as how it is tolerated when given together with~     Repevax. The study will be done in healthy adolescents.~   "
132316|NCT01323257|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a~     steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of~     erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the~     steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and~     tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r~     (Panel 2). Steady state is a term that means that the drug has been given long enough so~     that the plasma concentrations will remain the same with each subsequent dose. TMC435 is~     being investigated for the treatment of chronic hepatitis C virus (HCV) infection.~     Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in~     the body, and eliminated from the body.~   "
132317|NCT01323244|"~     The purpose of this study is to investigate the efficacy of a treatment with TMC435 in~     combination with peginterferon alfa-2a and ribavirin in patients who did not clear their~     hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial~     conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed~     against hepatitis C virus (HCV) were evaluated for short periods of time.~   "
132937|NCT01315093|"~     The addition of heparin increases pregnancy outcome parameters in poor responders undergoing~     In Vitro Fertilisation (IVF)~   "
132318|NCT01323231|"~     The objective of this study is to build upon preliminary research and conduct a pilot~     feasibility randomized controlled trial on a promising culturally-grounded and~     gender-specific treatment program, the XY-Zone. The central hypothesis underlying this study~     purports that through receiving the XY-Zone treatment, adolescents will decrease their risk~     for dropping out of school. This hypothesis is supported by two years of preliminary data~     investigating the effectiveness of the XY-Zone.~      To test the central hypothesis, the following specific aims will be pursued:~        1. Identify school dropout risk and protective factors (protective factors defined as:~          adult support and peer support; risk factors defined as: low school attendance,~          inability to achieve grade promotion, substance use, delinquency, school~          disconnectedness, misbehavior, disconnection from healthy peers) directly changed as a~          result of XY-Zone intervention.~        2. Determine the extent to which moderating variables (affective strength, duration in the~          program, family functioning, interpersonal strength, intrapersonal strength, level~          achieved in the program, and resiliency) effect change in outcome variables (risk and~          protective factors).~        3. Identify participants' beliefs about the impact of the mechanisms of change (respect,~          responsibility, relationship, role modeling, and reaching out) on outcome variables~          (risk and protective factors ) to enrich understanding of quantitative data.~   "
132319|NCT01323218|"~     Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with~     multiple comorbidities.~      OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation~     (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity.~     However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus~     and/or unstable neuromuscular output seem to be involved in this collapsus.~      A normal vitamin D status is necessary for normal muscle function and neuromuscular output.~     As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to~     evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D~     deficiency.~   "
132320|NCT01323205|"~     The purpose of this study is to explore the safety, tolerability, and potential clinical~     efficacy of JNJ 40411813 in schizophrenic patients.~   "
132321|NCT01323192|"~     The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses~     of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to~     placebo.~   "
132322|NCT01323179|"~     Observational study evaluating pain response after total knee arthroplasty (TKA) in patients~     taking strong, weak or no opioids preoperatively.~   "
132323|NCT01323166|"~     The purpose of the study is to compare self-reported health related quality of life after~     two different operating techniques for low rectal cancer operated by rectal amputation,~     using a specific and detailed questionnaire. The population has been operated over a 6 year~     period in one university hospital.~   "
132324|NCT01323153|"~     This double-blind, randomized, placebo-controlled, multi-center study will evaluate the~     safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome~     (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized~     to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time~     on study treatment is 20 weeks.~   "
132325|NCT01323140|"~     Watson's testosterone transdermal system delivers male sex hormone through skin for the~     treatment of men with sex hormone insufficiency.~   "
132326|NCT01323127|"~     The main objective of this study is to investigate the influence of seat type (straight~     chair versus ergonomic chair) on the sagittal alignment of the lumbo-pelvic complex in two~     different postures compared to standing for each individual in both a chronic-back-pain and~     a non-chronic-back-pain population.~   "
132327|NCT01323114|"~     Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In~     patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical~     evidence exists showing that significant clinical improvement in their diabetes occurs~     following certain types of bariatric, or weight loss, surgical procedures. There is~     additional data showing that bariatric surgical procedures that bypass the beginning of the~     small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes~     even before significant weight loss has occurred. This early effect on type 2 diabetes prior~     to weight loss suggests that bypassing the beginning of the small intestine in patients who~     are not morbidly obese may also treat type 2 diabetes. There have been small studies outside~     the United States that support the concept of treating type 2 diabetes with a surgical~     procedure that bypasses the beginning of the small intestine without causing significant~     weight loss; however, data is limited in the United States and a call for comparative~     studies has been made internationally. The investigators propose to compare, in patients who~     are not morbidly obese, conventional medical treatment of type 2 diabetes to surgical~     treatment of type 2 diabetes using a bypass procedure that does not cause significant weight~     loss, the laparoscopic duodenal exclusion.~   "
132328|NCT01323101|"~     Doxycycline is known to exhibit immune modulatory activities beyond its antibacterial~     effects. In particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9,~     which is a protease derived largely from neutrophils. Recent studies demonstrate a~     significant correlation between pulmonary disease severity and sputum concentrations of~     MMP-9 in patients with CF. In addition, sputum MMP-9 levels are associated with airway~     remodeling in CF.~      The goal of this study is to determine the therapeutic potential of doxycycline in~     modulating host airway inflammation in patients with CF. Specifically, the study will~     characterize the PK /PD of doxycycline, evaluate the safety of short term therapy, and~     explore the concentration effect relationship between doxycycline exposure and sputum~     biomarker levels.~   "
132329|NCT01323088|"~     In this randomized controlled trial, we will examine the effect of a 3-month exercise~     training (aerobic exercise versus resistance exercise) without calorie restriction on total~     and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2~     diabetes in overweight girls.~   "
132330|NCT01323075|"~     The primary objective is to demonstrate a longer period of neurologic recovery from a~     sensory block assessed in each test group versus the group without metabolic disease.~   "
132331|NCT01323062|"~     This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended~     phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in~     subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).~   "
132334|NCT01323023|"~     Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF)~     in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of~     Prescription for Health is to measure the extent to which comprehensive strategies are~     effective in changing patient behavior and quality of life relative to four target health~     risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will~     use a common set of survey instruments to help measure outcomes and draw overarching~     conclusions across projects. This study will only be analyzing aggregated data and does not~     have responsibility for recruitment of patients, randomization (if applicable), or~     interventions. Individual project designs may differ.~   "
132335|NCT01323010|"~     Metered dose inhalers with spacers are devices capable of providing higher rates of lung~     deposition of drugs such as beta agonists when compared to conventional nebulizers, but~     there is no consensus about the optimal dose when this is the device of choice and there is~     evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when~     compared to older children. Other factors that may interfere with response to albuterol~     treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious~     etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen~     that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children.~     Security of this new dosing regimen will be assessed by monitoring clinical side effects and~     serum levels of albuterol, but the investigators will also examine the presence of 12~     different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor~     genetics in the response to albuterol. The primary outcome measure will be the need for~     hospitalization. Secondary outcomes will include a change in clinical score, respiratory~     rate and forced expiratory volume in the first second, the need for additional treatments~     and length of stay in the emergency room for those not hospitalized.~   "
132336|NCT01322997|"~     Stroke is the leading cause of disability in the United States. One of the reasons that it~     is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is~     commonly seen after stroke.~      The objective of this research is to see if a robotic system worn on the weakened arm like a~     brace is more useful in improving the strength and coordination of the affected arm, and~     those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination~     after a stroke have great effects on how severely disabled the arm is and on quality of life~     after a stroke.~      In this study, patients may be administered a new robotic brace as part of treatment for~     their affected arms. If they use this brace, your electromyography (EMG) signals will be~     used to control the powered arm brace. EMG signals are the small electrical signals that~     result from the actions of the muscles. The system will listen to patients' muscles, using~     small sensors that sit on top of the skin. The device will give the arm a power-assist~     when patients bend or straighten their elbows. The investigators want to test how easy and~     effective this system is to use. The investigators hypothesize that people using the robot~     will be more successful in their rehabilitative efforts - and that their movement will~     improve more - than people receiving traditional therapy.~   "
132337|NCT01322984|"~     Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react~     abnormally to social stimuli, especially to human faces. Children and youth with ASD show~     less interest in social stimuli, and may even avoid looking at or interact with such~     stimuli. It has been proposed that social stimuli elicit reactions like fear and stress in~     individuals with ASD, and this explains the lack of interest and avoidance. The present~     project investigates this hypothesis.~   "
132338|NCT01322971|"~     Bacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift~     in the normal vaginal flora. BV has been associated with a number of poor reproductive~     outcomes, including infertility, preterm labor and premature rupture of membranes. If BV~     does disrupt normal embryologic development, then the treatment of BV prior to conception~     may improve implantation rates and other pregnancy outcomes in the infertile population.~      This is a prospective, randomized, double-blind, placebo-controlled trial in which infertile~     women undergoing intrauterine insemination or embryo transfer are screened for BV prior to~     treatment. Those patients who screen positive for BV will then be randomized into the~     treatment arm(metronidazole 500mg by mouth twice daily for 7 days) or the control arm~     (placebo by mouth twice daily for 7 days). The primary outcome, positive pregnancy test rate~     (i.e. biochemical pregnancy rate), will then be assessed. Secondary outcomes, such as~     clinical pregnancy rate, miscarriage rate, and live birth rate will also be examined.~   "
132339|NCT01322958|"~     Observational study of the use of ultrasound by emergency physicians in the evaluation of~     patients at risk of ectopic pregnancy.~   "
132340|NCT01322945|"~     The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery.~     This type of surgery is conducted for pituitary and skull base tumors. There is no published~     data on trauma to the nose during surgery and how it impacts nasal functioning. The~     investigators propose to develop a survey and administer it to patients before and after~     surgery to learn about their perception of nasal functioning.~   "
132341|NCT01322932|"~     The purpose of this study is to assess adherence, tolerability and satisfaction of each~     eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz~     (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.~   "
132342|NCT01322919|"~     By using a new software two consecutive laser treatments have been combined to correct the~     distance vision and to provide a near vision component in addition to the first treatment.~      This study will help us to answer 2 questions:~        1. How accurately this combined technique corrects distance and near vision~        2. Whether the correction is adequate to remove the complete need for supplementary near~          spectacles~   "
132343|NCT01322906|"~     Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure~     Caused by hepatitis B virus (HBV)~   "
132344|NCT01322893|"~     Women with metastatic breast cancer, receiving first line treatment of any kind~     (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this~     trial. In connection to treatment, blood samples for determination and enumeration of~     circulating tumour cells will be collected at different time points. Serum and plasma will~     be collected and stored for future analysis of RNA and DNA.~   "
135870|NCT01276483|"~     The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI~     and CT separately and combined for the evaluation of treatment response and progression-free~     survival in patients with GIST.~   "
132345|NCT01322880|"~     Over the last twenty years micro-finance based interventions have proven to be a popular and~     often effective means of improving the economic outcomes of impoverished women. However, the~     gains to microfinance based interventions on women's decision making in both economic and~     non-economic arenas remains largely unknown. Specifically, the question of to what extent~     does access to small-scale credit alone, rather than other programs often combined with~     microfinance, affect women's empowerment is of particular interest when determining~     interventions in a variety of setting in developing nations. There exists evidence that~     women's empowerment is associated with reduced violence and as such maybe an important tool~     for improving adult women's wellbeing. In addition increased decision making power by women~     has been associated with improvement in children's health outcomes, especially for girls,~     and as such may be way generating intergenerational improvements in women's outcomes.~      The goal of this project is to disentangle the effects of access to credit alone from the~     information on financial and personal decision making that is frequently coupled with these~     programs. To accomplish this, the investigators use a randomized field experiment among~     participants in Village Savings and Loans Associations (VSLA's). VSLA participants are a~     self-selected group of people who pool their money into a fund from which members can~     borrow. The money is paid back with interest, causing the fund to grow. The regular savings~     contributions to the VSLA are deposited with an end date (usually less than 1 year) after~     which all or part of the total funds are distributed to the individual members. The small~     loans are paid back with interest which is determined by the group at the time of formation~     and the returns from these interest payments are also distributed to the groups. The~     investigators then test whether there are additional gains to women's well-being by~     providing VSLA participants with training on process-based decision making to determine if~     there is a need for additional efforts to improve the decision making structure in~     households. To the extent that increased access to credit and more broadly financial~     resources is limited by existing constraints on women's decision making power, this~     additional training may be a necessary part of the creation of credit markets in improving~     the health and well-being of women and children.~   "
132346|NCT01322867|"~     A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine~     Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral~     Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form,~     Under Fasted Conditions in Healthy Volunteers.~   "
132347|NCT01322854|"~     The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial~     comparing intensity modulated radiotherapy with integrated boost to conventional~     radiotherapy with consecutive boost in patients with breast cancer after breast conserving~     surgery. 502 patients will be recruited and randomized in two arms: patients in arm A will~     receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed~     by an integrated boost, while patients in arm B will receive conventional radiotherapy of~     the breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a~     total dose of 66.4 Gy. Primary aim of the study is the assessment of the cosmetic outcome~     and local control after breast radiotherapy. The study hypothesis is that intensity~     modulated radiotherapy (IMRT) is, in spite of the reduced treatment duration, at least~     equivalent to conventional therapy.~   "
132348|NCT01322841|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. The investigators will be~     studying whether it can help in the diagnosis and treatment of tuberculosis and iron~     deficiency anemia.~   "
132349|NCT01322828|"~     The purpose of this study to to determine whether a single incision technique or a double~     incision technique is more effective in the surgical treatment of distal bicep tendon~     ruptures. Patients will be randomized to one of the two techniques upon consenting to the~     study. Prior to surgery patients will have their elbow flexion, extension, pronation, and~     supination strength measured. Elbow Range of motion will also be measured in each of these~     four movements. A number of subjective questionnaires will also be administered to the~     patient prior to surgery. The identical objective tests and subjective questionnaires will~     be completed by the patient at intervals of three months, six months, one year, and two~     years following their surgery. Additional information from patients clinical visits may also~     be collected throughout the study.~   "
132350|NCT01322815|"~     The purpose of this study is to test the safety of GI-4000 and see what effects (good and~     bad) it has against cancer over time. This study is also being done to measure the immune~     response to GI-4000. Study drug will be given in addition to a standard of care which is a~     standard therapy given to patients with your type of cancer (colon).~   "
132351|NCT01322802|"~     This phase I trial is studying the side effects of vaccine therapy in treating patients with~     stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may~     help the body build an effective immune response to kill tumor cells.~   "
132352|NCT01322789|"~     Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing~     pancreatic β-cells. The autoimmune response begins months or even years before the~     presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or~     acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells~     showed promising results in regulating immune system and promoting some degree of disease~     control. The aim of our study is to determine the safety and efficacy of intravenous~     infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.~   "
132353|NCT01322776|"~     This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40~     recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib,~     fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB~     activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL~     progression.~   "
132354|NCT01322763|"~     Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese~     children.~      Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and~     the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and~     neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A~     prospective transversal study.~   "
132389|NCT01322295|"~     Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6~     percent, but in patients more than 65-70 years the mortality is reported to be more than 10~     percent. The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome~     (ARDS) after infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well~     established. The degree of disability varies from a light degree of acute respiratory~     failure to mortality for patients with the same profile of risk.~      Primary aim is to develop a model that monitors inflammatory marker molecules collected from~     the bronchial epithelial lining fluid by microdialysis. The method with examination of the~     bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation~     markers as previously done by the investigators group.~   "
132390|NCT01322282|"~     This study is designed to assess bioequivalence between two products used for treatment of~     allergy.~   "
132391|NCT01322269|"~     The purpose of this study is to evaluate the safety and tolerability of three dose levels of~     HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.~   "
132355|NCT01322750|"~     With an estimated > 2 million women with undetected breast cancer in the United States, the~     need for improved early detection is imperative. Early diagnosis for these women is key to~     minimizing quality life-years lost to disease and optimizing success of treatment. Evidence~     now exists supporting the finding that systemic spread is an early event in the natural~     history of breast cancer, manifested as a release of single cancer cells from the incident,~     clinically undetectable tumor, which circulate through the bloodstream and deposit within~     remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is~     now possible with a simple peripheral venous blood draw. This study hypothesizes that women~     with CTCs and no other signs of malignancy have clinically undetectable disease.~      This study will attempt to validate this technology as a breast cancer screening test and~     acquire data to determine the clinical validity and utility of this proposed screening~     methodology on a relatively young, ethnically diverse population who are eligible military~     health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in~     order to perform additional molecular analyses in the future. The specific aims are to~     develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening~     test in order to identify subclinical disease early in its natural history in subjects at~     risk of progression to clinically apparent disease over the ensuing decade. The ultimate~     goal is to decrease the treatment-related morbidity and cause-specific mortality of breast~     cancer. An experienced team devoted to the care of patients with breast disease has been~     assembled to achieve this goal.~   "
132356|NCT01322737|"~     This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection~     System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a~     submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates~     the tissue from the underlying muscularis using a balloon to distend the submucosa, similar~     to what is currently performed with injectable saline in a standard EMR. After dissection of~     the lesion, a separate cutting device will be utilized to resect the tissue by cutting~     around the border of the targeted tissue. If needed, a standard loop snare will be used to~     complete the mucosal resection.~   "
132357|NCT01322724|"~     The purpose of this study will be to determine if the temperature of water used during~     insertion of colonoscopy makes a difference in patient discomfort and sedation requirements.~     The hypothesis of this study is patients receiving screening colonoscopy utilizing the water~     insertion method with room temperature (cool) water will have similar pain scores and~     medication requirements compared to water insertion method using body temperature (warm)~     water.~   "
132358|NCT01322711|"~     Primary and secondary prevention trials with statins, as well as with antiplatelet, clearly~     demonstrated that these drugs are able to reduce cardiovascular events. Even if the~     principal mechanism of action of statins is to lower cholesterol, other effects, the~     so-called pleiotropic effects, have been considered as adjunctive properties potentially~     accounting for the anti-atherosclerotic effect of statins.~      Inhibition of oxidative stress may be considered an intriguing pleiotropic effect in view of~     the fact that oxidative stress is thought to be a key event in the initiation and~     progression of atherosclerotic disease. Reduction of several markers of oxidative stress~     including isoprostanes, 8-hydroxydeoxyguanosine (8-OHdG), and nitrotyrosine have been~     observed after statin treatment. NADPH oxidase is among the most important sources of~     reactive oxygen species involved in atherosclerotic disease. The investigators developed an~     ELISA to evaluate serum levels of soluble-gp91phox, the catalytic core of phagocyte NADPH~     oxidase. Recently the investigators showed that statins (30 days treatment) exert an~     antioxidant effect via inhibition of soluble gp91phox expression.~      The exact mechanism by which atorvastatin reduces NADPH oxidase, however, is unclear. Recent~     study showed that statin treatment inhibits leukocyte ROCK activity, a protein kinase~     implicated in the activation of NADPH oxidase, with a mechanism that seems to be independent~     from lowering cholesterol. To further study the mechanism(s) implicate in gp91phox~     downregulation by statin the investigators planned the present study in patients with high~     risk of vascular events such as hypercholesterolemic and Type 2 Diabetes mellitus patients.~      In addition the investigators want to evaluate the synergistic role of atorvastatin with~     aspirin treatment.~   "
132359|NCT01322698|"~     Our primary objective is to evaluate the relevance of the early determination of Candida~     infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.~   "
132360|NCT01322685|"~     The purpose of this study is to study the Development and Application of Rapid Nucleic Acid~     Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are~     health group and Tuberculosis or lung cancer group in order to compare with the difference.~   "
132361|NCT01322672|"~     Recent data suggests that anesthetics can have prolonged effects on gene expression, protein~     synthesis and processing as well as cellular function in ways that the investigators are~     only beginning to understand, especially in the very young and the elderly. Within moments~     to days of emerging from anesthesia - cardiac or non-cardiac - some patients experience mild~     to very severe disorientation and changes in memory and thinking ability without apparent~     cause. For the vast majority of patients, this Post-Operative Cognitive Dysfunction (POCD),~     generally subsides, but for some with diminished cognitive reserve - especially the~     elderly, those with less education or prior CNS events such as stroke or early dementia -~     changes in memory and executive function may persist. If prolonged for more than three~     months, POCD has been linked to an increased risk of death. In 1-2% of elderly patients, the~     problem may ultimately continue for more than a year, leading to a loss of ability to care~     for themselves and early demise. Though this may seem like a small percentage, seniors will~     comprise up to 40% of the 50-75 million surgical procedures performed annually over the next~     20-30 years. This amounts to 70,000 - 200,000 elder affected, and for them and their~     families, the cost of POCD in longer-term care, lost wages, and extended suffering will~     remain very high.~   "
132362|NCT01322659|"~     The purpose of this study is to determine whether helmet is effective as device for~     noninvasive positive pressure ventilation in the weaning from mechanical ventilation.~   "
132392|NCT01322256|"~     The investigators' primary objective is to assess the predictive power of PET/CT scanning in~     the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy~     prescribed by national and international recommendations.~   "
135939|NCT01275586|"~     The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas~     treated with Tasgina® respond to therapy.~   "
132363|NCT01322646|"~     There is clear, converging evidence from multiple prospective studies with well-diagnosed~     adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have~     more accidents and other adverse driving outcomes. Available research indicates parental~     monitoring and limit-setting for adolescent drivers is one of the most effective~     interventions for preventing negative driving outcomes. For children with ADHD,~     interventions to promote parenting capacity to effectively oversee and intervene in teen~     driving will likely need to be intensive and require multiple treatment components. The~     present proposal aims to compare the standard care for teen drivers (driver's education~     classes and driving practice) to the Supporting a Teen's Effective Entry to the Roadway~     (STEER) program, that includes a parent-teen intervention, adolescent skill building, parent~     training on effective adolescent management strategies, joint parent-teen negotiations~     sessions, practice on a driving simulator, parental monitoring of objective driving~     behaviors, and the targeting of safe teen driving via contingency management strategies~     (i.e., parent-teen contracts). To facilitate teen and parent engagement the intervention~     will be preceded by a motivational interview. The specific aims of the proposal are to~     investigate the efficacy of the STEER program relative to a standard care group in a~     randomized clinical trial (N=172) on measures of objective driving outcome and parenting~     capacity. It is hypothesized that the STEER program will result in improved outcomes~     relative to the standard care group at the end of intervention and 6 and 12 month follow-up~     assessments.~   "
132364|NCT01322633|"~     The primary objective is to assess whether the risk of gastric cancer is increased in~     pantoprazole users compared to users of other proton pump inhibitors.~   "
132365|NCT01322620|"~     This study is conducted in Africa, Asia, Europe, North America and South America.~      The purpose of the survey is to identify the key psychosocial issues affecting patients with~     haemophilia.~   "
132366|NCT01322607|"~     Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an~     extremely high energy cost of movement and contributing to overall disability and lower~     quality of life. Therefore, interventions targeting movement economy should be developed for~     those in the chronic phase of stroke recovery. This study is designed to compare the effect~     of two distinctly different exercise paradigms (a higher-intensity treadmill training~     program and a lower-intensity group exercise program) on economy of movement during~     over-ground walking and activities of daily living, as well as the extent to which gains in~     muscular strength, muscular endurance, and balance predict changes in movement economy.~   "
132367|NCT01322594|"~     Phase I study to evaluate the safety and tolerability of single ascending intravenous doses~     of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease~     (COPD).~   "
132368|NCT01322581|"~     Plasmodium falciparum (Pf) malaria remains a major cause of morbidity and mortality~     worldwide. A malaria vaccine would contribute towards efforts to control and eliminate~     malaria. Optimism that an effective malaria vaccine can be developed is derived in part from~     the observation that repeated Pf infections can induce protective immunity; however, the~     mechanisms underlying acquired malaria immunity remain unclear. The goal of the current~     study is to apply systems biological tools to an observational cohort in an area of intense~     seasonal Pf transmission to gain insight into the mechanisms underlying naturally acquired~     malaria immunity. This year-long observational-cohort study of 700 individuals (3 months and~     25 years of age) will be conducted in the rural village of Kalifabougou, Mali, where Pf~     transmission is intense and seasonal. Asymptomatic Pf infection and malaria episodes will be~     detected by passive and active surveillance. Immune parameters of malaria-protected and~     -susceptible individuals will be assayed from blood samples collected at strategic time~     points relative to the malaria season. The primary objective is to identify genome-wide~     expression profiles induced by Pf infection that are associated with protection from~     malaria. Secondary objectives include identifying age-related (surrogate for cumulative Pf~     exposure) changes in Pf-induced gene-expression and serum cytokine profiles, and examining~     Pf-specific antibody profiles that are associated with protection from malaria using a~     protein microarray representing 2000 Pf proteins (40 percent of the Pf proteome).~     Exploratory objectives for this study are to compare the magnitude and quality of the~     Pf-specific CD4 plus T cell response in malaria-protected and -susceptible individuals and~     determine how this response varies with age and among individuals before, during, and after~     malaria season, as well as compare various immune parameters in Pf-infected and uninfected~     individuals at the end of the dry season to investigate host immune factors associated with~     chronic asymptomatic Pf infection.~   "
132369|NCT01322568|"~     Background:~      - Researchers are interested in studying the environmental and genetic factors that play a~     role in health and living conditions as people age. Since 2002, the U.S. National Institute~     on Aging and the Icelandic Heart Association Research Institute have been conducting a~     long-term study known as the Research in Aging project to collect personal data and samples~     from Icelandic men and women in order to study risk factors related to disease and~     disability in old age. Researchers plan to initiate a second stage of the study.~      Objectives:~      - To collect additional personal information, medical records, and blood samples from~     individuals who have previously provided materials for the Research in Aging Project in~     Iceland.~      Eligibility:~      - Individuals who have previously participated in the Research in Aging project in~     association with the U.S. National Institute on Aging and the Icelandic Heart Association~     Research Institute.~      Design:~        -  Participants will have a physical examination with imaging analysis procedures and~          hearing and eye tests, provide information on health and diet, and provide a 100-ml~          blood sample for testing.~        -  Participants will also provide consent for researchers to consult data and samples~          collected during the first stage of the Research on Aging project.~   "
132375|NCT01322477|"~     HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its~     prevalence is growing. The most effective treatment of HCC is surgical and includes~     resection and liver transplantation; however, only 20% of the patients can be treated~     surgically. Local interventional therapy, such as radiofrequency (RF) ablation and~     transarterial embolization is also used.~      Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases~     and in up to 20% after liver transplantation.~      Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent~     to significantly improve the overall survival in advanced HCC. However, the drug has serious~     side effects and is very expensive.~      PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.~      The value of the FDG PET for evaluation of HCC is controversial, in particular due to the~     unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies~     suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF)~     and metastatic spread of HCC, including detection of active disease only suspected by AFP~     (alphafoetoprotein) elevation.~      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change~     of treatment as early as possible,when the tumor is non-responsive before serious side~     effects appear or before depletion of body resources.~      The aim of our study is to investigate the contribution of FDG PET/CT to assessment of~     treatment response.~   "
132370|NCT01322555|"~     Background:~      - People with autism and autism spectrum disorders have problems with communication,~     behavior, and socializing, and many also have intellectual and developmental disabilities.~     The cause of autism is not known, but previous research has suggested an association between~     autism and immune changes in the brain. Researchers are interested in using the experimental~     radioactive drug (11C)PBR28, which attaches to a protein in the brain that is involved in~     immune changes, in positron emission tomography (PET) scanning of people with and without~     autism to see if there are greater immune changes in those with autism.~      Objectives:~      - To determine if positron emission tomography scanning can be used to evaluate changes in~     an immune system protein in the brains of people with autism.~      Eligibility:~      - Individuals between 18 and 45 years of age who have been diagnosed with either autism or~     autism spectrum disorders, or are healthy volunteers.~      Design:~        -  Participants will be screened with a physical examination and psychological~          examination, medical history, questionnaires about behavior and mood, and blood and~          urine tests.~        -  Participants will have two imaging studies of the brain at separate study visits. The~          first study visit will involve a magnetic resonance imaging (MRI) scan to provide a~          baseline image of the brain. The second study visit will involve PET scan with the~          radioactive chemical (11C)PBR28 to study immune system proteins in the brain. The MRI~          scan will take about 40 minutes, and the PET scan will take about 2 hours.~        -  Participants will have a final study visit 24 hours after the PET scan to provide a~          final blood sample for testing.~   "
132371|NCT01322529|"~     Forty percent of pregnant women in the United States are women who have never given birth.~     As a group, they sometimes have complications with their pregnancy, but there is no~     information from a previous pregnancy to identify who might have a problem. Very little~     research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring~     Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women~     who are having their first baby and are carrying only one baby. The women are enrolled early~     in pregnancy and undergo research assessments four times during their pregnancies. Data are~     collected through interviews, self-completed data forms, clinical measurements, ultrasound,~     and collection and storage of blood samples, urine samples, and fluid from the vagina and~     cervix. Some information comes from medical records. A subset of women may be asked to~     participate in substudies collecting information on sleep breathing, sleep patterns and~     quality, or other areas possibly related to birth outcomes. The goal of the research is to~     find ways to identify women in this group who might develop a problem with their pregnancy~     and use this information to improve the health of pregnant women and their babies in the~     future. The study is focusing on pregnancy problems like high blood pressure, babies that~     are born much too early and very small babies.~   "
132372|NCT01322516|"~     We propose to follow a cohort of pregnant and post-partum Canadian women through the fall~     and winter of 2009/2010 and the anticipated second and third waves of the current pandemic~     in order to better understand the incidence, complications and risk factors for severe~     disease due to H1N1 influenza in pregnant women, and to contribute data on the safety and~     effectiveness of antivirals and vaccines in this population.~      The primary hypotheses to be tested are:~      (i) pandemic influenza infection in the second and third trimester of pregnancy is~     associated with an increase in adverse fetal outcomes (fetal loss, stillbirth, neonatal~     mortality, significant neonatal morbidity, prematurity) (ii) close contact with young~     children (<2 yrs) at home or work is the most important risk factor for influenza in~     pregnant women (iii) higher scores on a scale of community infection prevention (a~     combination of self-reported hand hygiene adherence, avoidance of ill persons and avoidance~     of crowds) are protective against influenza (iv) receipt of seasonal influenza vaccine from~     2007 to 2009 will increase the risk of illness due to influenza A(H1N1)v in the second and~     third waves of the pandemic.~      (v) pandemic influenza vaccine is effective in preventing symptomatic influenza in pregnant~     women.~      (vi) vaccination of pregnant women against a particular strain of influenza protects their~     infants against influenza infection in the first six months of life.~   "
132373|NCT01322503|"~     Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to~     Norovirus infections.~      Description of Study Design: Healthy volunteers with different blood types and low antibody~     titers to the challenge strain will be challenged orally with a Norovirus in the CCCR~     inpatient facility. Subjects with resistant (non-secretors) or susceptible (secretors (of~     either A, B or O blood group)) to the challenge strain will be recruited. The challenge~     study will be conducted in two groups of twenty, each with approximately ten secretors and~     ten non-secretors. Three additional subjects per group will serve as alternates in the event~     that any of the study subjects are unavailable or become ineligible at the time of the~     inpatient study. Subjects will be monitored daily in the isolation facility for at least~     five days following this challenge for daily clinical and virological evaluations. Subjects~     will return to the investigational site for evaluation the day after discharge from the~     inpatient unit and about 30 days (28-35 days) post challenge.~      Study Endpoints: Norovirus infection as assessed by viral shedding, seroconversion and~     clinical illness assessed by the duration and severity of symptoms~   "
132374|NCT01322490|"~     The purpose of this study is to determine whether PROSTVAC alone or in combination with~     GM-CSF is effective in prolonging overall survival in men with few or no symptoms from~     metastatic, castrate-resistant prostate cancer.~   "
132376|NCT01322464|"~     Study to assess effect of food on the bioavailability of a single dose of Sativex and to~     measure its' pharmacokinetics after a single and multiple doses.~   "
132377|NCT01322451|"~     The purpose of the study is to evaluate the relative bioavailability of two solid oral~     formulations of GLPG0259 administered after a meal.~   "
132378|NCT01322438|"~     The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how~     your body absorbs and distributes BAY73-4506.~   "
132428|NCT01321788|"~     Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism~     (VTE). VTE remains the most common cause of maternal death in the developed world. It is up~     to 10 times more common in pregnant women than non-pregnant women of comparable age. More~     than a third of pregnancy-related VTE occurs during the six weeks after delivery. When~     compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy~     associated VTE by three-fold.~   "
132379|NCT01322425|"~     The pathophysiology of pain related to fibromyalgia is not understood. This condition is~     difficult to diagnose and to treat. One clue may be that tender points (areas which hurt~     typical of fibromyalgia) are most densely located near the clavicles. This is also the area~     where brown fat is located in humans. Brown fat is typically used to maintain body~     temperature. Stress (such as cool temperature or special diets, i.e., high fat, low~     carbohydrate) appears to worsen the pain seen in fibromyalgia. We hypothesize that a~     mechanism for pain in this disease relates to activating brown fat through neural~     mechanisms. The nerves to brown fat also go into adjacent muscle and skin. So, when brown~     fat is turned on or increases in amount, collateral nerves may cause pain at the tender~     points.~      The central hypothesis is that stress such as temperature or diet will activate brown fat.~     Patients with fibromyalgia will have greater activation or volume of brown fat. Neuralgia~     related to stress may be the etiology of the pain. If this hypothesis is proven, there are~     several drugs on the market that could be deployed to correct these patients' problems.~     Therefore, this project, if successful, will lead to clinical trials of these drugs in~     fibromyalgia patients.~   "
132380|NCT01322412|"~     Physical exercise has been identified as a major item of many chronic diseases and cancer~     rehabilitation.~      Therefore, physical activity for health is a valid and relevant way to improve quality of~     life and to manage cancer patient fatigue. The aim of the study is the assessment of the~     effects of a physical activity retraining program on aerobic capacity, strength and fatigue,~     in a breast cancer population treated by adjuvant chemotherapy.~   "
132381|NCT01322399|"~     The primary purpose of study is the collection of feasibility data for a larger trial of~     Structural Integration (SI)(an alternative manual therapy) for chronic low back pain. The~     secondary purpose is the collection of preliminary data on 1) the therapeutic effect of SI~     plus usual care versus usual care alone - the hypothesis being the the effect size will be~     significantly greater in the SI plus usual care arm; and on 2) specific hypothesized~     mechanisms of that hypothesized therapeutic effect: a) improvements in cognitive behavioral~     factors; b) improvements in standing balance and gait, and c) improvements in selected blood~     biomarkers.~   "
132382|NCT01322386|"~     The goals of the proposed work are two fold:~      Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary~     Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what~     effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal~     tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the~     investigators hope to learn to characterize human intestinal microbial communities~     (microbiome: the collection or collectivity of microorganisms) using molecular methods,~     examine the mechanisms of interaction between host and microbiome using genomic approaches,~     and determine how the microbiome both preserves local health and promotes pathology. The~     investigators will focus on primary sclerosing cholangitis, biliary atresia, as well as~     states of health. The composition of the associated microbiome will be assessed based on~     ribosomal DNA and RNA sequences, and attention will be given to richness (diversity),~     evenness (relative abundance), and variation with respect to time, person, and anatomic~     niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide~     gene expression patterns.~   "
132383|NCT01322373|"~     This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain~     information on Alzheimer's disease (AD) progression, the stability of healthy control (HC)~     MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend~     the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under~     development by the sponsor, Orasi Medical. The current study is intended to extend the~     database of AD and HC MEG scans and will include patients who previously enrolled and~     completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately~     50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard~     functional tests while HC subjects will complete 2 standard functional tests. ApoE~     genotyping also will be determined for all subjects. The results generated in this study~     will be used to improve the accuracy of the SNI test for diagnosing and tracking the~     progression of AD.~   "
132384|NCT01322360|"~     The purpose of this study is to evaluate the tolerability and safety of oral morphine~     sulfate in the treatment of postoperative pain in different pediatric age groups following~     multiple-dose administration.~      To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.~      To compare plasma concentration of morphine sulfate in each age group of pediatric subjects~     with adult plasma morphine sulfate concentrations.~   "
132385|NCT01322347|"~     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric~     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in~     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy~     will be measured primarily by the change from baseline in hemoglobin (Hgb).~   "
132386|NCT01322334|"~     Upper airway resistance during sleep can present with a range of symptoms from simple~     snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or~     collapse leads to reduction or cessation in airflow during sleep, and is associated with~     loud snoring.~      The investigators hypothesized that regular singing exercises could strengthen pharyngeal~     muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus~     quality of life in patients with all forms of snoring.~   "
132387|NCT01322321|"~     This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a~     mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.~   "
132388|NCT01322308|"~     The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial~     function in premenopausal women with SLE (systemic lupus erythematosus). Patients with~     hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast~     feeding women. This is a randomized, double blind, placebo controlled study.~   "
132429|NCT01321775|"~     The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab,~     trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+~     followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin~     liposomal).~   "
133011|NCT01314105|"~     This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to~     treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in~     patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma~     or primary peritoneal cancer.~   "
132393|NCT01322243|"~     In this study, we would like to explore the hypothesis that changes in metabolic state,~     induced by altering hormone levels and patterns of neural activity, affect the experience of~     anxiety in humans. We will also investigate if there is a link between high anxiety and~     higher caloric intake. Our aim is to characterize whether changes in current metabolic state~     systematically influence anxiety induced by a well established behavioral task known as the~     threat of shock. The neural regions activated by this behavioral task in healthy subjects~     have been well characterized. We have a priori regions of interest that include the insula,~     anterior cingulate cortex, hypothalamus, amygdala, and prefrontal cortex. As our primary~     outcome, we will assess neural activation with whole-brain functional magnetic resonance~     imaging to determine whether brain regions are differentially engaged when subjects~     experience anxiety across different metabolic states. We will correlate these changes with~     psychophysiological measures of anxiety and metabolic state.~   "
132394|NCT01322230|"~     The purpose of this study is to compare the educational efficacy of instructional design~     enhancements in on-line learning modules in the context of clinical medical education.~   "
132395|NCT01322217|"~     This study will collect information on health status and risk behaviors, as well as basic~     demographic and biomedical information for a group of HIV positive adolescents receiving~     care at sites newly participating in ATN III.~   "
132396|NCT01322204|"~     The purpose of this study is to determine the absorption and bioavailability of codeine in~     relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug~     (codeine), its active metabolites, their formation rates and their ratios in relation with~     PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study~     population and their potential relationship to the biodisposition and pharmacodynamic~     effects of codeine. The study population is intubated and mechanically ventilated infants~     equal to or greater than 26 weeks gestational age at birth and less than 4 weeks postnatal~     age.~   "
132397|NCT01322191|"~     This study was originally undertaken to evaluate the analgesic efficacy of an intravenously~     administered dose of ketorolac compared with intravenous morphine in the relief of acute,~     postoperative pain in children admitted to the Intensive Care Unit. Using the urine and~     plasma samples originally collected from patients in the morphine treatment group and which~     were never analyzed, this proposal seeks to study the pharmacokinetics and metabolism of~     intravenous morphine in critically-ill children along with its concentration-related~     efficacy using prior measures of pain.~   "
132398|NCT01322178|"~     The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as~     treatment could improve the resection rate in patients with KRAS wild-type, unresectable~     liver metastases of mCRC.~   "
132399|NCT01322165|"~     The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular~     Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute~     (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases~     (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be~     related to thoracic aortic aneurysms and collected medical data and biologic samples. The~     study ended in September 2016. Data and samples are available from NHLBI and requests should~     be made to BioLINCC. See the NHLBI website for more information:~     https://www.nhlbi.nih.gov/research/resources/gentac/.~   "
132400|NCT01322152|"~     The objectives of this study are to evaluate the efficacy and tolerability of single-week~     regimen of irinotecan plus capecitabine in the first-line or second-line treatment of~     advanced colorectal cancer.~   "
132401|NCT01322139|"~     This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when~     administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic~     dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.~   "
132402|NCT01322126|"~     The purpose of this study is to determine whether use of the ultrasound to locate the~     epidural space and assist with performing neuraxial anesthesia will decrease numbers of the~     attempts required for successful placement of epidural catheter.~   "
132403|NCT01322113|"~     This study deals with the possible molecular mechanisms that underlie the etiology of~     bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous~     digitalis-like compounds (DLC) in the depressive state of this disease. The possibility,~     however, that they are also involved in the manic phase of the disease was never addressed.~     The results of this study may have significant implications for the treatment of BD by DLC~     derivatives.~   "
132404|NCT01322100|"~     Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a~     novel electrode device has been developed for treatment in soft tissue such as the brain. Up~     to 18 patients will be treated in this phase I dose-escalating study of electrochemotherapy~     for brain metastases. Primary endpoint of the clinical trial is safety and secondary~     endpoint is efficacy. One brain metastasis is treated once-only with the electrode device~     guided stereotactically through a burr hole using CT monitoring. The patient will be fully~     anesthetized during the treatment procedure. Patients are followed up for 6 months with~     regard to neurological function, Barthel Index, steroid use and adverse effects registration~     (CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).~   "
132405|NCT01322087|"~     Rationale:~      The objective of this study was to investigate whether a new energy dense food concept, on~     order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at~     nutritional risk. The investigators target was for 70% of patients to reach 75% of their~     energy and protein requirements.~      Methods:~      An intervention study was conducted with inclusion of 40 patients at nutritional risk,~     according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes.~     Patients could choose food from both the new concept and the ordinary patient buffet. The~     investigators monitored patients' nutritional requirements and daily nutritional intake.~   "
132406|NCT01322074|"~     In this study we evaluate if there is a correlation between acute pain and systemic~     inflammatory markers after total Knee Arthroplasty (TKA).~   "
132504|NCT01320800|"~     This 5-year study addresses the unmet needs of adolescents with social phobia through the~     testing of a 12-week cognitive-behavioral, school-based group intervention delivered by~     trained school counselors compared to a nonspecific school counseling program. A secondary~     goal is to provide further examination of the efficacy of the CBT program delivered by~     school counselors as compared to the same program delivered by psychologists.~   "
132407|NCT01322061|"~     Opioids are the corner stone in the treatment of post operative pain. Because of the several~     side effects of opiods, non-steroidal anti-inflammatory drugs are usually added~     postoperatively to decrease the total requirements of opioids. However, non steroidal~     anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side~     effects when used on short-term basis, has been shown to have promising analgesic effects in~     chronic pain and acute pain relief following orthopedic surgeries.~      The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C~     in reducing the intensity of pain and the consumption of opioids in patients undergoing~     laparoscopic cholecystectomy at AUB-MC.~      All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in~     the study. Patients will be randomized into two groups to receive either single dose oral~     vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both~     the patients and the investigation team will be blinded to the type of intervention.~     Intraoperative anesthesia management will be similar for both groups. Postoperative pain~     control will be achieved with patient controlled analgesia via a patient controlled morphine~     pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain~     scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and~     patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C~     concentration will be determined for each patient.~      Patients demographics will be obtained and compared between both groups. The differences in~     pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and~     patient satisfaction scales will be compared between the two groups with the Student-t test,~     the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak~     vitamin C plasma concentration will be correlated with the pain scores in each group using~     regression analysis.~      This study will provide relevant information on whether a single dose (2g) of vitamin C can~     reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus~     eliminating their side effects in patients undergoing laparoscopic cholecystectomy.~   "
132408|NCT01322048|"~     The investigators intend to determine the effect of adrenergic blockade on 1) short-term~     physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after~     severe Traumatic Brain Injury (TBI).~      The primary hypothesis is that adrenergic blockade after severe TBI will be associated with~     increased ventilator-free days.~   "
132409|NCT01322035|"~     This study compares the improvement of weight, fasting lipid profile (triglycerides,~     cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in~     levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).~   "
132410|NCT01322022|"~     This study will compare the efficacy of a behavioral parent training program (PT) aimed~     specifically at common sleep disturbances compared to parent education (PE) program focusing~     on general issues related to autism. In a sample of 40 well characterized young children who~     meet criteria for an autism spectrum disorder (24-72 months), the investigators will test~     whether the five session PT program is superior to the PE program in decreasing sleep~     disturbances.~      The primary aim of this study is to evaluate the efficacy and feasibility of a PT program~     for sleep disturbance in young children with autism compared to PE.~      To this end, there are two hypothesis:~        -  Hypothesis 1: After the end of treatment, PT will be significantly more effective than~          PE in improving parent reports of a) bedtime struggles and resistance; b) sleep~          latency; c) night wakings; d) morning wakings; and / or e) sleep association problems~          as measured by the composite sleep index score from the modified Simonds and Parraga~          Sleep Questionnaire (MSPSQ; Simond & Parraga, 1982; Wiggs & Stores, 1998).~        -  Hypothesis 2: At the end of treatment, children in the PT group (n=20) will display~          significantly improved total sleep period as measured by actigraphy in comparison to~          children in the PE group (n=20).~      The secondary aim of this study is to evaluate the impact of participating in PT on child's~     daytime behavior and functioning and parenting stress compared to PE.~      To measure this aim, there are 4 exploratory hypothesis:~        -  Exploratory Hypothesis 1: Lower Irritability subscales scores will be reported on both~          parent and teacher / therapist completed Aberrant Behavior Checklist (ABC) for the PT~          group than the PE group at 4 weeks and 8 weeks~        -  Exploratory Hypothesis 2: Lower Child Behavior Checklist (CBCL; parent completed) and~          Caregiver-Teacher Report Form (C-TRF; teacher completed) scores will be reported for~          the PT group than the PE group at 4 weeks and 8 weeks.~        -  Exploratory Hypothesis 3: The PT group will have higher scores on the Vineland Adaptive~          Behavior Scales: 2nd Edition (VABS-II) at 4 weeks and 8 weeks compared to PE group.~        -  Exploratory Hypothesis 4: Parents receiving PT will report significantly lower scores~          on the Parenting Stress Index (PSI) at 4 weeks and 8 weeks compared to parents~          receiving PE.~   "
132411|NCT01322009|"~     The overall purpose of this research study is to investigate the safety of pharmacological~     therapies that may potentially improve pediatric outcomes after traumatic brain injury.~     Traumatic brain injuries are the leading cause of death and disability among children and~     young adults.~      Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after~     TBI and can overcome barriers to the brain and synergistically improve bioavailability and~     efficacy the antioxidant content of the body and CNS after TBI.~   "
132412|NCT01321996|"~     The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with~     idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP~     (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and~     European Respiratory Society criteria) and in forms of NSIP (non-specific interstitial~     pneumonia). PET/CT imaging data will be compared with HRCT (high-resolution computed~     tomography) findings to assess disease extension, early disease detection and to~     non-invasively detect somatostatin receptors expression at lung level in these patients,~     with potential therapeutic implications.~   "
132413|NCT01321983|"~     OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to~     attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung~     volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.~      Therefore, the hypothesis of the present study was that preoperative IMT is able to~     attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the~     lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients~     undergoing open bariatric surgery.~      DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil.~     SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly~     assigned to receive preoperative inspiratory muscle training (IMT group) or usual care~     (control group).~      MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal~     expiratory pressure - MEP), lung volumes and diaphragmatic excursion.~   "
132414|NCT01321970|"~     Our primary goal is to validate a new diagnostic tool for functional coronary artery~     stenosis that uses multimodal imaging (combining stress echocardiography and stress~     scintigraphy) in patients with known coronary chest pain.~   "
132415|NCT01321957|"~     The primary objective of this study is to evaluate the efficacy of Irinotecan in combination~     with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of~     patients with metastatic colorectal cancer.~   "
132446|NCT01321554|"~     This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare~     the progression free survival of participants with 131 I -refractory DTC and radiographic~     evidence of disease progression within the prior 12 months, treated with lenvatinib 24 mg by~     continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a~     Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind~     treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment~     Period and a follow-up period).~   "
132447|NCT01321541|"~     The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to~     Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell~     lymphoma (DLBCL), or follicular grade 3 lymphoma.~   "
132505|NCT01320787|"~     The goal of this clinical research study is to find out the highest tolerable dose of an~     imaging solution called 18-F-fluoroacetate sodium that can be given before a positron~     emission tomography (PET) scan. The safety of this solution will also be studied.~   "
132416|NCT01321944|"~     Tobacco use is the leading preventable cause of death in the United States. Effective~     treatment for tobacco dependence exists and includes counseling and pharmacotherapy with~     nicotine replacement, bupropion, or varenicline. The health care system is a key channel for~     delivering this treatment to smokers. Brief clinical interventions delivered at office~     visits increase smoking cessation rates, are among the most cost-effective of medical~     interventions, and are recommended by U.S. Public Health Service. However, physicians and~     other clinicians often fail to provide them. Clinicians' rates of providing tobacco~     treatment in ambulatory care can be improved, but even when successful, clinicians can only~     reach smokers who make an office visit.~      A health care system might improve its delivery of tobacco treatment by supplementing~     visit-based efforts with a population-based strategy, using methods proven effective in~     public health settings. A population of smokers could be identified from electronic health~     records and offered treatment proactively in a way that maximizes convenience and minimizes~     barriers such the cost of pharmacotherapy. This study tests the effectiveness of a~     population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one~     community health center in Revere, MA, that is part of an integrated health care system. It~     uses the system's population management tools to identify smokers and proactively offers~     them evidence-based tobacco treatment that is free and does require making an office visit.~     A randomized controlled trial will compare the effectiveness of the DTS program to usual~     primary care. The hypothesis is that adding the DTS program to usual primary care will~     increase the proportion of smokers who use tobacco dependence treatment and thereby stop~     smoking.~   "
132417|NCT01321931|"~     Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A~     study in healthy smokers.~   "
132418|NCT01321918|"~     The main objective of this study is the formation of a DNA bank to realise a case-control~     genetic study designed to identify sequence variations in DNA that predispose to sudden~     cardiac death in adults.~      The secondary objective of this study is the creation of a register for epidemiological~     surveillance of adult extra-hospital sudden death.~   "
132419|NCT01321905|"~     The vast majority of Cystic Fibrosis (CF) patients worldwide are vitamin D insufficient.~     There is no evidence of benefit of vitamin D supplementation for CF patients yet. However,~     descriptive cross-sectional studies suggest that vitamin D might be beneficial with respect~     to bone health, as well as to the newly described non-classical functions of vitamin D~     such as the potential anti-diabetic and immunomodulatory effects. To prove causation, and to~     determine which serum vitamin D concentration is optimal for CF patients, vitamin D~     supplementation interventional studies are needed, such as our trial.~   "
132420|NCT01321892|"~     The purpose of this research study is to collect information on whether images made using~     investigational microscopes can improve researchers' ability to evaluate and distinguish~     between normal and abnormal areas in tissue samples surgically removed from patients with~     squamous cell carcinoma. The microscopes being used in this study are considered~     investigational because they have not been approved by the United States Food and Drug~     Administration (FDA) for finding abnormal or pre-cancerous areas.~   "
132421|NCT01321879|"~     The goal of this clinical research study is to learn if Vibativ (telavancin) can help to~     control blood stream infections (BSIs). The safety of this treatment will also be studied.~      Objectives:~      Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive~     bacteremia in cancer patients (including neutropenics).~   "
132422|NCT01321866|"~     The main objective of this study is to evaluate and compare the primary patency rate at 12~     months in a group of hemodialysis patients operated on by cutting balloon and in a group of~     hemodialysis patients operated by conventional balloon.~   "
132423|NCT01321853|"~     The purpose of this study is to determine whether a home care medication management program~     which includes nurse coordination and use of the MD.2 medication-dispensing machine will~     affect older adults' health outcomes, satisfaction, use of health care services, and health~     care costs over a one year period. The investigators propose a longitudinal three group~     repeated measures design, enrolling, and randomly assigning, clients who are discharged from~     a home health care agency with documented problems in medication management. One group will~     receive the MD.2 medication dispensing device and nurse coordination, the second group will~     receive a Medplanner: a simple box that has separate compartments for individual medication~     times over the course of a week plus nurse coordination, and the final group will receive~     Usual Care.~      The study hypotheses are the following:~      H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive~     trajectory in physical and mental health status, functional status, cognitive status and~     depressive symptoms over the course of a year than will the Medplanner Group.~      H2: With respect to health status outcomes, the Medplanner Group will exhibit a more~     positive trajectory in physical and mental health status, functional status, cognitive~     status and depressive symptoms over the course of a year than will the Usual Care Group.~      H3: The rate of hospitalization, hospital days and emergency department visits will be~     significantly lower for the MD.2 Group as compared to the Medplanner Group.~      H4: The rate of hospitalization, hospital days and emergency department visits will be~     significantly lower for the Medplanner Group as compared to the Usual Care Group.~      H5: The nursing home admission rate will be significantly lower for the MD.2 Group as~     compared to the Medplanner Group.~      H6: The nursing home admission rate will be significantly lower for the Medplanner Group as~     compared to the Usual Care Group.~      H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the~     Medplanner Group.~      H8: The total cost of care will be significantly lower for the Medplanner Group as compared~     to The Usual Care Group.~      H9: There will be incremental savings in terms of costs per quality adjusted life year~     (QALY) gained in the MD.2 group compared with the Medplanner Group.~      H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner~     group compared with the Usual Care Group.~   "
132424|NCT01321840|"~     The aim of the study is to test, if patients suffering from Endometriosis show changes in~     their brain function, when being treated with SART (Systemic Autoregulation Therapy), a~     complex intervention consisting of interventions from Traditional Chinese Medicine (TCM) and~     Western Hypnotherapy. Functional and structural brain changes are assessed using Magnetic~     Resonance Imaging data which are analyzed by means of voxel-based morphometry (VBM),~     connectivity and perfusion analysis. A third outcome measure are changes of patients' heart~     rate variability, indicating the activity of their autonomic nervous system.~      With a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation~     regularity, dyspareunia, defecation pain, and quality of life are assessed during the SART~     treatment.~      During the treatment, we expect to see changes in cortical thickness, functional~     connectivity and perfusion of pain-related areas of the cortex, that correlate with the~     changes in heart rate variability.~   "
132425|NCT01321827|"~     The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy~     in patients with ABPA.~   "
132426|NCT01321814|"~     The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT)~     can be useful for people suffering from Hyperacusis.~      Also, the investigators are interested in investigating this group of patients on~     psychiatric and somatic comorbidity, personality traits, and startle response to sounds.~      The investigators will also study the audiological measures commonly used in Sweden to~     measure hyperacusis, and investigate their validity.~      The investigators hypothesize that CBT might be helpful for patients suffering from~     Hyperacusis.~   "
132427|NCT01321801|"~     The purpose of this study is to evaluate how effective is the preoperative administration of~     pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic~     cholecystectomy.~   "
132430|NCT01321762|"~     Pelvic organ prolapse (POP) is one of the most common indications for gynaecological~     surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in~     USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK,~     the disorder accounts for 20% of the women on the waiting list for major gynaecological~     surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk~     factors. Furthermore a racial and congenital predisposition has been reported. The cause of~     this disorder is likely to be multifactorial and attributable to a combination of factors,~     varying from patient to patient.~      Controversy exists as to whether the pregnancy per se rather than the mode of delivery~     alters the risk of POP. Caesarean section appears to protect against the development of~     prolapse. However, when a caesarean section is undertaken during the active stage of labour~     it may not be completely protective. Ideally prospective longitudinal studies are needed to~     study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately,~     studies to date, are small with poor follow-up and have only assessed objective outcome~     rendering it difficult to draw conclusions. The primary objective of our study was to~     objectively assess the impact of pregnancy and childbirth on pelvic organ support using the~     Pelvic Organ Prolapse Quantification (POPQ)System.~   "
132431|NCT01321749|"~     This study is a prospective, randomized, single-center trial, designed to observe the effect~     of remote limb ischemic preconditioning on ischemic cerebral vascular disease.~   "
132432|NCT01321736|"~     Dietary fiber is known to influence bowel function. The investigators hypothesize that the~     addition of a mixture of fibers to liquid diets will improve bowel function as measured by~     stool weight.~   "
132433|NCT01321723|"~     This study is designed to provide information about the bone anabolic properties and~     absorption profile of Unigene's PTH Analog when administered as oral tablets over a period~     of 24 weeks to postmenopausal women with osteoporosis.~   "
132434|NCT01321710|"~     The purpose of this study is to test a behavioral intervention to minimize sleep disruption~     and fatigue in new mothers after the birth of their first infant. This study also tests~     whether an acetaminophen intervention at the time of an infant's 2-month immunization series~     improves infant and maternal sleep.~   "
132435|NCT01321697|"~     This will be a non-blinded, non-randomized study to further our knowledge of and experience~     with lymph node surgery. The investigators are interested in documenting and reporting the~     variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral~     lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer~     Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone,~     Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this~     study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer~     Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or~     contralateral groin who have not had prior groin surgery or radiation to the groins.~     Patients must meet inclusion and exclusion criteria to be enrolled.~   "
132436|NCT01321684|"~     For unilateral spinal block, spinal local anesthetics should take effect on the spinal~     nerves of one side. With full flexion of the spine, the cauda equina becomes tightened and~     hangs in the middle of the subarachnoid space. This study was performed to assess if flexion~     of the vertebral column facilitates unilateral spinal anesthesia.~   "
132437|NCT01321671|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of a~     pregabalin controlled release (CR) tablet administered fasted in the evening relative to a~     single dose of the CR tablet administered immediately following a 600 to 750 calorie evening~     meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will~     also be compared to the single dose pharmacokinetics of the pregabalin immediate release~     (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be~     evaluated.~   "
132438|NCT01321658|"~     This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal~     cancer. The patients will be randomized into two groups. The control group will receive~     standard surgical treatment. The intervention group will in addition go through a~     preoperative comprehensive geriatric assessment. The assessment will include evaluation of~     co-morbidity and medication, social status, nutritional status, cognition, depression and~     physical performance. This assessment will form basis of an individualized perioperative~     intervention.~      The main aim of the study is to see if the number of postoperative complications in this~     group can be reduced by a perioperative geriatric intervention. A study of inflammation~     markers in serum will also be performed, with focus on identifying potential biological~     frailty markers.~   "
132439|NCT01321645|"~     Acne is one of the most common skin problems in teenagers and adolescents. There are many~     lesser known homoeopathic medicines which have been mentioned in the literature for~     treatment of acne but their potential has not been properly assessed /documented and~     therefore these medicines don't form a part of many prescriptions. As a part of this~     study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris~   "
132440|NCT01321632|"~     Acne is one of the most common skin problems in teenagers and adolescents. There are many~     lesser known homoeopathic medicines which have been mentioned in the literature for~     treatment of acne but their potential has not been properly assessed /documented and~     therefore these medicines don't form a part of many prescriptions. As a part of this study,~     efficacy of Zingiber officinalis will be studied in the treatment of Acne vulgaris~   "
132441|NCT01321619|"~     The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared~     to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal~     syndrome.~   "
132442|NCT01321606|"~     The investigators have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared~     to placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The~     probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus~     gastrointestinal colonization when taken for four weeks.~   "
132443|NCT01321593|"~     The purpose of this study is to compare the hemoglobin results obtained with the Orsense~     NBM-200MP device and the Clinical Laboratory.~   "
132444|NCT01321580|"~     The purpose of this study is to compare the hemoglobin results obtained with the Masimo~     Pronto 7 and the Clinical Laboratory.~   "
132445|NCT01321567|"~     To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with~     Proton Pump Inhibitor-resistant reflux esophagitis~   "
132448|NCT01321528|"~     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie~     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry~     of their thoughts and beliefs connected to stressful circumstances or symptoms. This~     meditative process, named The Work, enables the participants to identify and question the~     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and~     a turnaround, which is a way of experiencing the opposite of what the participant believes.~     This process is simple, powerful and can be easily implemented in daily life.~      Therefore, on the basis of previous data and beneficial observations the investigators~     postulate that the clinical utility of IBSR mediation program may alleviate stress and rate~     of burnout and improve quality of life among health care professionals. Thus, we will~     conduct a pilot/feasibility Observational study designed to:~        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and~          program satisfaction.~        -  investigate whether IBSR intervention is efficacious in alleviating stress and rate of~          burnout and improving quality of life among health care professionals.~   "
132449|NCT01321515|"~     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets~     under fasting conditions.~   "
132450|NCT01321502|"~     The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets~     under fed conditions.~   "
132451|NCT01321489|"~     The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate~     20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of~     action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.~   "
132452|NCT01321476|"~     This study will use excess tissue from endoscopic or surgical procedures to examine the~     elements of plaque that are found in the carotid walls of patients who have a type of heart~     and blood vessel disease called atherosclerosis. Tissue will be collected from patients~     undergoing carotid procedures as well as patients undergoing liver and/or intestinal~     biopsies. This lab study will examine the different types of proteins that play a role in~     developing heart plaque.~   "
132453|NCT01321463|"~     PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is~     associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its~     potential safety and efficacy profile in COPD.~   "
132454|NCT01321450|"~     Including 150 randomised patient, the studies aim is to determine whether an economisation~     and/or improvement in terms of operating time, drainage fluid, blood loss, time of~     hospitalisation can be found using an ultrasonic dissection device versus traditional~     surgical methods such as stitches an ligations.The study is performed for patients~     undergoing partial pancreatoduodenectomy.~   "
132455|NCT01321437|"~     The purpose of this research study is to determine the efficacy of Axitinib in treating~     individuals with Stage III melanoma.~   "
132456|NCT01321424|"~     The purpose of this study is to measure the change in Tear Osmolarity during the course of~     the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and~     differentiate between the two forms of dry eye.~   "
132457|NCT01321411|"~     Respiratory muscles (the muscles used to breathe) need more blood (and oxygen) when their~     workload increases. It is difficult to measure respiratory muscle blood flow (RMBF) without~     invasive techniques. We will evaluate a new, much less invasive technique to measure RMBF in~     2 groups: Healthy Volunteers and Critically Ill patients on breathing machines. The purpose~     of this study is to determine the accuracy of this new monitoring technique called Near~     Infrared Spectroscopy Utilizing Indocyanine Green Dye when compared with traditional~     measurements. The information gained from this study will help us to provide better care to~     patients with severe lung problems.~   "
132458|NCT01321398|"~     Patients with severe lung conditions occasionally require support with a special ventilator~     (breathing machine) called the High Frequency Oscillator (HFO). Effective ventilation~     requires that the pressure generated by the ventilator be as high as possible but not too~     high as this can damage the lungs. In patients on HFO, there is not a well defined way to~     measure this pressure. We will insert a small probe into the esophagus of patients on HFO to~     see if this is an accurate way to measure lung pressures for these patients. A better~     understanding of these pressures could lead to improved patient care.~   "
132459|NCT01321385|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors predict how well patients will respond to treatment.~      PURPOSE: This research trial is studying biomarkers in predicting response to treatment in~     bone marrow samples from young patients with acute myeloid leukemia.~   "
132460|NCT01321372|"~     Hematology patients are at high risk for invasive fungal infection (IFI) and are being~     treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that~     patients' serum drug levels are within therapeutic ranges when undergoing treatment. The~     primary objective of this study is to determine whether clinical responses~     (complete/partial/failure) directly correlate with patients' blood VOR drug levels.~      In patients whose disease progression is associated with inadequate voriconazole (VOR) drug~     levels, serum drug level determination can allow for dose adjustment, thereby preventing~     disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR~     levels leading to treatment failure whereas, poor metabolizers may have high drug levels~     that cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping~     tests can also be helpful in determining patient risk subjecting to extreme spectrum of drug~     levels.~   "
132461|NCT01321359|"~     Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis~     (RHL).~   "
132477|NCT01321151|"~     Sports-related concussions are a serious problem in football, boxing, and other full contact~     sports. After experiencing consecutive concussions, there is an increase in neurological~     deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat~     this increase in brain damage, novel strategies need to be developed to protect athletes~     that are participating in these full contact sports. The purpose of this study is to~     elucidate whether resveratrol decreases brain injury and improves brain function after~     experiencing a concussion in boxers.~   "
132506|NCT01320774|"~     The purpose of this observational study is to evaluate the efficacy, tolerability, quality~     of life and handling of Daivobet® Gel by both physician and patient in daily practise.~   "
132462|NCT01321346|"~     This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL),~     Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL).~     Panobinostat is a new drug that is considered investigational because it has not been~     approved in the United States by the Food and Drug Administration (FDA), or in any other~     country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene~     expression found in cells causing them to stop growing or die. Panobinostat has been used in~     several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has~     not been given to children.~      This is a phase I study. In a phase I study, drugs are tested to the highest dose that can~     be safely given. Drugs are given at gradually increasing dosages until there are~     unacceptable side effects. The goal of the Phase I study is to find out the dose of~     panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL.~   "
132463|NCT01321333|"~     This study will evaluate the effect of single transplantation of HuCNS-SC cells into the~     thoracic spinal cord of patients with sub-acute spinal cord injury.~   "
132464|NCT01321320|"~     The primary hypothesis for this study is that Myostatin and FHL-1 are important in the~     development of ICUAP and that changes in activity levels of muscle will modify the levels of~     expression and activity of these proteins.~   "
132465|NCT01321307|"~     Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants~     of Israel are known to use carob extract to ease sores in the mouth, due to the tannins~     which create a complex with various proteins and polysaccharides, thus creating an~     impenetrable layer covering the sores, allowing spontaneous healing.~   "
132466|NCT01321294|"~     The aim of this study is to compare subjective and objective outcome and surgical side~     effects of Nissen and Toupet fundoplication performed in a single institution by only two~     surgeons and to compare pre and postoperative findings to healthy individuals.~   "
132467|NCT01321281|"~     Osteoarthritis (OA) is the most common kind of arthritis and primarily affects the large,~     weight bearing joints (including the knees, lower back, hips, neck and the feet) and the~     joints in the hands. OA results from the breakdown of cartilage in joints, leading to joint~     pain and damage. It affects about 8 million people in the United Kingdom and nearly 27~     million people in the United States, most of whom are over the age of 45.~      This study aim to determine if Aquamin (as AquaCal and AquaPT) affects molecules of~     inflammation in the blood of osteoarthritis and healthy subjects.~   "
132468|NCT01321268|"~     To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat~     deposits and quality of life.~   "
132469|NCT01321255|"~     The aim of the FOCUS project is to test the Fixed Dose Combination concept for~     cardiovascular prevention in populations of different socio-economic characteristics. At the~     same time, FOCUS aims to understand the factors determining inappropriate prescribing for~     secondary cardiovascular prevention and those for poor patients adherence to treatment. This~     will allow FOCUS to establish recommendations for a better use of medication in patients~     with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary~     prevention medication will be available and affordable for a large number of patients in~     both developed as well as developing countries.~      There are two Phases in this study:~      Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional,~     randomized trial with prospective economic evaluation.~   "
132470|NCT01321242|"~     This is a multicenter survey of Russian data on target heart rate achievement in patients~     with stable angina and arterial hypertension who are currently treated with beta-blockers~     for at least 2 months and with no dose change for a minimum of 4 weeks~   "
132471|NCT01321229|"~     The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after~     stroke. The association of the sleep respiratory troubles with a reserved functional~     prognosis is debated. The purpose is to find out the frequency of the sleep respiratory~     troubles after stroke in a PRM department and to study their relationship with functional~     and neurological recovery.~   "
132472|NCT01321216|"~     This study aims to determine the contribution of rotavirus infection as a cause of~     gastroenteritis requiring hospitalization in children younger than 5 years of age.~     Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause~     these infections as prevalent in Lebanon.~   "
132473|NCT01321203|"~     To assess the safety and efficacy of CO2 insufflations during ERCP~        1. Primary objective:~           To assess the patient's symptoms, abdominal pain and abdominal distension post~          procedure (ERCP) in the study group.~        2. Secondary objective:~      Endoscopist:~        -  To assess the adequacy of bowel distension for adequate luminal visualization~        -  To assess the peristaltic movement during the ERCP~      Anesthetist:~        -  To measure the PCO2 level in patient post procedure.~        -  To assess the amount of sedation required during the procedure.~        -  To assess saturation and vital signs through out the procedure.~        -  To assess requirement of buscopan.~   "
132474|NCT01321190|"~     One way to better understand how various treatments for pain differ is to determine the~     effects of these treatments on different pain qualities or characteristics. For example,~     pain can be described as hot, electrical, cold, achy, and piercing. In order to~     determine which pain quality/qualities that a pain treatment affects, researchers must~     develop measures of these pain qualities or characteristics. The purpose of this study is to~     learn more about the different pain qualities individuals who have low back pain, headaches~     and fibromyalgia experience. Identifying the common qualities of pain experienced by these~     groups will help researchers evaluate and develop more comprehensive pain quality measures,~     which will ultimately help them to be able to test the effectiveness of treatments for these~     different pain qualities.~   "
132475|NCT01321177|"~     The purpose of this study is to determine how services should be provided to reduce symptoms~     and improve life functioning for adolescents and adults who have been recently diagnosed~     with schizophrenia.~   "
132476|NCT01321164|"~     The main objective of the study is to evaluate the additional effect of a narrow band Type B~     Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid~     esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the~     effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach~     Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate~     whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a~     positive predictive factor for the treatment response.~   "
132480|NCT01321112|"~     As is well known, immunosuppressive treatment (IS) after liver transplantation has several~     and frequents adverse effects that limit the survival of the graft and recipients. Because~     of that, it is desirable that these recipients were able to receive a mild IS regime with a~     better safety profile. An attempt to get that aim has been evaluated in several trials in~     the past, and consist in to change the IS regime from an calcineurin inhibitors (CNI) based~     to another less intense and with less adverse effects based on mycophenolate mofetil (MMF),~     which is known to have a better safety profile. The success rate of this strategy(i.e.~     complete conversion in absence of rejection) has a wide range from 100% to 50%~     approximately. However it is accepted that this strategy is associated with the improvement~     of several adverse effects of CNIs such as renal failure and dyslipemia. This study's aim is~     to perform IS conversion from CNI to MMF monotherapy and look for transcriptional biomarkers~     employing a whole genome expression study performed with microarrays at baseline on liver~     tissue and/or PBMCs to try to find a differential gene expression able to correlate with a~     successful conversion and thus, to generate a set of transcriptional biomarkers potentially~     able to predict the result of the IS conversion on an independent cohort of liver~     recipients.~   "
132481|NCT01321099|"~     Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron~     deficient children have an increased risk for anemia which is associated with adverse infant~     development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in~     children is multifactoral; but the major causes are low iron dietary bioavailability and~     intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit~     from iron-fortified complementary foods; however, these fortified complementary foods are~     often not adapted to the requirements of children in specific setting. The investigators~     developed a complementary food fortificant (CFF) which is added to local porridge and is~     deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The~     CFF is lipid-based and can therefore, if regularly used, increase the daily energy intake of~     children which is often too low in developing countries with cereal-based diets.~      The iron absorption from the mixture of CFF and porridge has to be optimized because it~     contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To~     optimize iron absorption the investigators are planning three iron absorption studies using~     different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is~     able to degrade phytate. In the first study, iron absorption will be determined from a~     mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional~     vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a~     mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with~     1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and~     phytase. Iron absorption will be determined by incorporation of labeled iron into~     erythrocytes, 14 days after the administration of a test meal containing labeled iron~     (stable isotope technique). Sixty apparently healthy Beninese children 12-36 months of age~     with a body weight > 8.3 kg will be included in the study. Additionally, the investigators~     will test acceptability of CFFs based on different composition formulas by interviewing the~     parents/legal guardians of the children after feeding the CFF for a defined period.~      The results of these studies will provide important insights to optimize the iron absorption~     of young children from a CFF mixed with local traditional porridge in developing countries.~     Furthermore the studies will provide information on the acceptability of CFFs in such a~     setting.~   "
132482|NCT01321086|"~     The investigators are conducting a clinical research trial to determine the role of~     motivational interviewing (MI) on promoting home-based walking therapy to improve walking~     ability in African Americans with peripheral arterial disease (PAD). African Americans are~     more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with~     PAD, there is a significant risk for poor walking ability and limb loss. One major treatment~     for PAD is walking therapy but the traditional methods for the delivery of this treatment~     have required frequent visits to a university or hospital-based site. The investigators will~     address the role of self-managed walking program, to be conducted at or near the home, to~     improve limb function. In order to motivate the participants to walk, the investigators~     included two different intervention strategies: MI and patient-centered counseling for~     exercise (PACE). The investigators hypothesize that participants randomized to the MI arm~     will have a greater increase in their walking distance, compared to those receiving~     Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.~   "
132483|NCT01321073|"~     The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the~     Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic~     SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection.~   "
132484|NCT01321060|"~     Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the~     treatment for this is controversial. In this study, the investigators aim to evaluate the~     different effects of three different treatment protocols which is repeated aspiration,~     continuous catheter drainage and conservative treatment. The investigators suppose repeated~     aspiration could not only solve acute fluid collections, but also lower the rate of~     pancreatic infection.~   "
132485|NCT01321047|"~     Based on previous results, the investigators considered that sedation quality,~     complications, and procedure outcomes may not be different, however, propofol alone~     titration may have a fast recovery time than BPS and cost-effectiveness than balanced~     propofol sedation (BPS). In present study, the investigators therefore evaluate the time and~     sedation quality of patient recovery, cost-effectiveness, complication, and procedure~     outcomes between propofol alone and BPS in therapeutic endoscopic retrograde~     cholangiopancreatography (ERCP).~   "
132486|NCT01321034|"~     Objectives.~        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg~          day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60~          mg/dL) and very high Lp(a) (> 60 mg/dL).~        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg~          day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on~          the apo(a) gene. 2.1.1 Hypotheses.~        -  The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a)~          concentration, with higher absolute and relative reduction in Lp(a) in subjects with~          hyperlipoproteinemia(a).~        -  Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related~          to the lowering effect variability of niacin in human.~   "
132487|NCT01321021|"~     This project aims at identifying novel pharmacological targets for the treatment of memory~     disorders.~   "
132488|NCT01321008|"~     The goal of this clinical research study is to learn if radiation therapy and chemotherapy~     can help control stage 1 and/or 2 NK cell lymphoma. The safety of radiation and chemotherapy~     will also be studied.~   "
132489|NCT01320995|"~     The main objective of this study is to compare the rate of anal incontinence (measured by~     the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among~     primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at~     delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of~     women who do not benefit from screening.~   "
132490|NCT01320982|"~     The objective of the study is to evaluate the efficacy of Pramipexole, Minocycline and~     Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with~     schizophrenia.~   "
132491|NCT01320969|"~     It is well-established that the practice of mindfulness meditation leads to improvements in~     mental health and well-being and the cultivation of positive emotions. However, the neural~     mechanisms of these improvements are largely unknown. A few recent studies suggest that~     mindfulness meditation impacts the structure and function of the ventromedial prefrontal~     cortex, the hippocampus, and the amygdala. Interestingly, recent studies have shown that~     these regions are part of a brain circuit that is critical for the extinction of conditioned~     fear responses, and for the retention of fear extinction memory. Building on the overlap of~     these regions and on conceptual considerations, the project investigates whether mindfulness~     meditation could influence one's capacity to retain the memory of fear extinction.~     Meditation-naïve participants will be randomized to either a mindfulness-meditation based~     training or an active control training that controls for all mindfulness-unspecific~     components. Participants will undergo a fear conditioning, extinction and extinction recall~     protocol in an MRI scanner before and after the trainings. We hypothesize that participants~     who have practiced mindfulness meditation will show greater improvements in fear extinction~     memory after the course, and that these improvements will be correlated with anatomical and~     functional changes in the brain regions of interest. Improvements in fear extinction memory~     will also be related to improvements in self-reported psychological well-being. Merging the~     fields of an ancient spiritual tradition and a fundamental learning mechanism, the project~     investigates the underlying neural mechanisms of a practice for the enhancement of mental~     health and well-being.~   "
132492|NCT01320956|"~     This study aims to find how hypnosis performed just before a painful surgery can change~     anxiety level, in children aged 10 to 18 years.~   "
132493|NCT01320943|"~     Withdrawal of antiviral therapy can result in hepatic or alanine aminotransferase (ALT)~     flares as Hepatitis B Virus (HBV) replication resumes; however, in some participants, a~     flare exacerbates chronic hepatitis temporarily but can also result in viral clearance.~     Hepatic flares are common after stopping anti-HBV therapy.~      Only participants who already are on treatment with tenofovir disoproxil fumarate (TDF)~     monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and~     who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years~     will be included in this study. One treatment arm will stop the TDF therapy while the other~     treatment arm will continue the TDF therapy.~      Participants in the Stop TDF arm will be monitored very closely with special focus on~     biochemical flares (especially ALT increases) and virological relapses (Hepatitis B viral~     load increases). If any participant in the Stop TDF arm exceeds one or more predefined~     limits for such flares or relapses, TDF will be reinstituted.~      The study will assess Hepatitis B surface antigen (HBsAg) loss (i.e. specific Hepatitis B~     virus components are no longer detectable) and seroconversion (occurrence of Hepatitis B~     surface antibody, a specific antibody which usually occurs after HBsAg loss) rates during~     study duration. The percentage of participants who need to restart TDF therapy in the Stop~     TDF arm will also be evaluated.~   "
132494|NCT01320930|"~     The study is a single-center randomized, unblinded, placebo-controlled study to investigate~     the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive~     pulmonary disease (COPD).~   "
132495|NCT01320917|"~     Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular~     risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on~     these alterations in patients with PCOS.~      To assess the effects on arterial function and structure and hemostatic parameters using an~     levonorgestrel intrauterine device (IUS-LNG) in women with obesity~      A randomized controlled clinical trial.~   "
132496|NCT01320904|"~     Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES)~     combined with closed kinetic chain (CKC) exercises in patients with knee OA.~   "
132497|NCT01320891|"~     Aim of the study is to ascertain whether a different strategy of fluids administration can~     be responsible of differences in terms of acid/base disorders (Stewart approach),~     pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated~     either with not-balanced solutions (Normal Saline) or balanced solutions~   "
132498|NCT01320878|"~     The objective of this study was to assess the efficacy and appropriate dose of iloprost for~     inhalation in the treatment of postoperative pulmonary hypertension in children with~     congenital heart defects.~   "
132499|NCT01320865|"~     The investigators hypothesize that bone marrow progenitor cells are mobilized into the~     circulation in PAH, home to the lungs and differentiate into mast cells, which promote~     vascular remodeling and vasoconstriction through release of renin and chymase. As a~     corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor~     (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell~     progenitor proliferation, mobilization and differentiation. To test this, the investigators~     will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib~     clinical response. This will be an ancillary study, part of a placebo-controlled,~     double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.~   "
132500|NCT01320852|"~     This study aims at testing the utility of PET Scan as a screening tool for liver~     transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for~     liver transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed~     until 2 years after transplantation. At that time survival data will be analysed according~     to PET Scan results to determine if it can be used to predict outcome.~   "
132501|NCT01320839|"~     We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot~     orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will~     decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis~     use will be greater during an attention demanding task.~   "
132502|NCT01320826|"~     It is hypothesized that primary care colonoscopists are able to achieve benchmarks in~     colonoscopy quality including cecal intubation and adenoma detection rates and serious~     adverse event rates.~      This prospective study is the first in depth analysis of the quality of colonoscopic~     procedures performed by primary care physicians at a provincial level in Canada.~      In addition, the APC Endo study is the first to directly examine both the quality of~     colonoscopy and patient satisfaction in the same study.~   "
132503|NCT01320813|"~     The main objective is to compare 12 month complication rates between a new surgical method~     for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and~     open thyroidectomy.~   "
132508|NCT01320748|"~     The purpose of this study is to determine whether drug-dependent adults who participate in a~     dual processing relapse prevention treatment protocol that allows for sensory-based exposure~     experiences over 10-weeks in outpatient treatment will show significant brain change related~     to diminished cue reactivity, and greater improvement in self-efficacy, anxiety,~     somatization, and treatment retention, as compared to the standard care patients in a~     relapse prevention program.~   "
132509|NCT01320735|"~     The objective of this study was to describe treatment patterns of leuprorelin over 2 years~     using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)~   "
132510|NCT01320722|"~     The investigators hypothesize that, among non-hypertensive overweight and obese individuals,~     treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine~     oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system~     (RAS) activation, improve endothelial function, and lower blood pressure.~   "
132511|NCT01320709|"~     In this study the effect of piroxicam on the ovulation will be evaluated. Therefore~     piroxicam will be administered as a single-dose after onset of LH surge (luteinizing~     hormone, hormone which triggers ovulation).~      Additionally blood levels of endogenous hormones (hormones produced by your body) will be~     measured and transvaginal ultrasound examinations will be conducted at regular intervals. In~     addition the concentration of piroxicam in blood will be determined in regular intervals.~      With regards to the tolerability of the study drug subjects will be asked regularly how they~     feel.~   "
132512|NCT01320696|"~     The purpose of the study is to identify the optimal dose level of a reverse genetic (RG)~     reassortant H9N2 pandemic influenza vaccine for further product development.~   "
132513|NCT01320683|"~     This phase II trial studies how well giving combination chemotherapy and bevacizumab before~     surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in~     patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin~     calcium, fluorouracil, and oxaliplatin (FOLFOX), work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90~     DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing~     substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody~     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs~     to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any~     tumor cells that remain after surgery~   "
132514|NCT01320670|"~     Epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1%~     of the general population. People with uncontrolled epilepsy suffer poor health and~     increased mortality due to their condition. They frequently experience social stigma and are~     socioeconomically disadvantaged. It is therefore imperative to help them gain control of~     their seizures as quickly as possible. A wide range of antiepileptic drugs (AEDs) has become~     available to treat people with epilepsy. However, despite maximal therapy, approximately~     20-40% show pharmacoresistance (PR) and thus continue to have seizures.~      We do not understand why a significant proportion of people with epilepsy have PR. For any~     given patient presenting with a first unprovoked seizure, we are unable to predict PR at the~     time of presentation. At least 2 different AEDs must be tried at maximum doses for a year~     before we can diagnose PR. At this point, surgical therapies become an increasingly urgent~     consideration.~      Retrospective magnetic resonance imaging (MRI) studies in the chronic stages of epilepsy~     have shown that patients with PR are more likely to have focal structural lesions in the~     brain, and in particular to have signs of damage to the hippocampi. For example, there are~     retrospective data suggesting that a decreased hippocampal N-acetylaspartate (NAA)/creatine~     ratio (measured by magnetic resonance spectroscopy [MRS]) and hippocampal atrophy~     (determined by hippocampal volumetry) correlate with PR. However, it is not clear whether~     these findings reflect the underlying pathophysiology of PR, or simply reflect the effects~     of chronic seizures and chronic drug treatment on the brain.~      The First Seizure Clinic at the Halifax Infirmary represents a unique opportunity for~     prospective, longitudinal studies of patients who present with a first seizure or with newly~     diagnosed epilepsy. In these patients, advanced neuroimaging techniques at presentation~     might show changes that truly reflect the underlying pathophysiology of PR, rather than~     changes that develop as a consequence of prolonged seizures and drug treatment. Neuroimaging~     follow-up might help us to understand the pathophysiologic changes that accompany the~     evolution of PR. Ultimately, it is our hope to combine neuroimaging features and clinical~     features of patients with PR in a predictive model that would help us to predict PR at~     presentation.~   "
132515|NCT01320657|"~     This is a clinical study involving patients undergoing orthodontic treatment with fixed~     appliances ('train-track braces'). A new type of train-track has recently been marketed.~     Over 4 million patients worldwide are wearing on of these appliances; this system is~     considerably more expensive than a normal train-track. However, there is little evidence to~     support its use.~      The effects of three different types of train-track will be assessed with respect to the~     quality of Orthodontic tooth movement produced. Furthermore, the impact of the different~     train-tracks on daily life of orthodontic patients will also be measured. Consequently, the~     investigators will be able to inform orthodontists' decisions relating to the choice of~     train-track they recommend for their patients. In addition, should the more expensive~     appliances demonstrate objective or subjective advantage, a significant efficiency saving~     may develop.~   "
132516|NCT01320644|"~     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce~     in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial.~     THis protocol will review the one year outcome of patients who underwent this pocedure using~     a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.~   "
132517|NCT01320631|"~     The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor~     functional status and ultimately improving the patient's quality of life. There are a few~     studies that have explored the effect of pelvic reconstructive surgery on female sexual~     function (1,2) but no studies have evaluated the male partner's sexual experience. The~     investigators intend to use a newly psychometrically validated questionnaire to capture this~     aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and~     exclusively combine functional and quality of life concepts (erection, individual~     satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more~     focused and less burdensome evaluation of the sexual experience in men (3). Another issue is~     the density of the mesh material and if it can be felt vaginally even if it is not eroded~     and to what degree this might bother the male partner during intercourse.~   "
133091|NCT01313273|"~     The aim of the study is to compare in an exploratory fashion the efficacy on~     progression-free survival of lanreotide in addition to non steroidal anti androgens and~     LHRH-a in non metastatic castrate resistant prostate cancer patients.~   "
132518|NCT01320618|"~     Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce~     in regard to long term outcome. This advanced procedure is offered at Morristown Memorial.~     This protocol will review the one year outcome of patients who underwent this procedure~     using a polypropylene mesh. These outcomes will include anatomical and quality of life~     measures.~   "
132519|NCT01320605|"~     Compound HP802-247 comprises two topical sprays, administered sequentially right after~     another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface.~     HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg~     ulcers. The present study will enroll up to five patients who are suffering venous leg~     ulcers, have failed a prolonged course of standard wound therapy and one or more advanced~     technologies, but who would not qualify for the Phase 2 study.~   "
132520|NCT01320592|"~     This study is a phase I, single arm, open-label trial of PD0332991 in combination with~     Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are~     anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel.~     Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled~     at that dose to establish the RP2D, obtain additional safety data and perform exploratory~     biomarker studies.~   "
132521|NCT01320579|"~     The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of~     2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult~     patients with moderate or severe chronic atopic dermatitis.~   "
132522|NCT01320566|"~     The purpose of this study is to assess the long term safety and efficacy of AeriSeal System~     treatment administered at up to 4 subsegments during a single treatment session for lung~     volume reduction in patients with advanced emphysema through 48 weeks after treatment.~   "
132523|NCT01320553|"~     The present study will test if administration of different concentrations of 1334H eyedrops~     will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or~     older.~   "
132524|NCT01320540|"~     Currently, many breast center patients with a positive family history receive information~     about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery~     or at a time point that does not allow them to use testing results in making their surgical~     decision. Diagnostics, decisions and interventions are often out of sequence, resulting in~     test information not available in time for decisions. Tests are often repeated. Decisions~     and interventions are delayed, are not understood by breast cancer patients or proceed~     without the test information, resulting in suboptimal care and resource waste (Donaldson MS.~     2005, Katz SJ 2007, IOM 2001).~      In this study, BRCA testing information will be delivered to patients at the point of breast~     imaging. For patients that are diagnosed with breast cancer, this provides ample time to use~     the test results in making their surgical decision, if they elect to be tested. The~     investigators will work with health care providers to insure family history data are~     collected at the breast imaging visit, develop a standardized BRCA patient education~     handout, enlist health care providers to insure the information is delivered to the~     appropriate patient population, and coordinate scheduling with genetic counseling services~     to insure patients are promptly seen.~      The investigators hypothesis is that an intervention of providing patients indicated for~     genetic/familial risk with timely information and opportunity to access genetic counseling~     during breast imaging will shift BRCA testing to before definitive breast cancer surgery,~     for patients with a breast cancer diagnosis, and could impact surgical decisions. The~     investigators will identify barriers to this intervention from the perspective of patients,~     physicians, nurses, and genetic counselors. The investigators will then adjust the~     intervention to overcome the barriers and will test the intervention at the point where~     genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at~     breast imaging. If indicated, patients will be provided information and will be referred to~     genetic counseling to consider BRCA tests.~   "
132525|NCT01320527|"~     Based on prior published pilot studies, the investigators have initiated a larger,~     multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and~     individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming~     (or denying) the above promising clinical findings, and (2) determining whether or not our~     formulation can delay MCI conversion to AD.~   "
132526|NCT01320514|"~     The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in~     reducing the incidence of early postoperative bruising and swelling.~   "
132527|NCT01320501|"~     An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as~     single agent~   "
132528|NCT01320488|"~     Breast cancer is the leading cancer among women in Saudi Arabia representing almost the~     third of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently~     observed at young age. The data on this observation is either lacking or scares.~     Furthermore, the pathological and molecular features of breast cancer in young women are not~     clear. The study will provide important information to the national health care planner~     about this disease in young women including shedding light on possible genetic risk factors~   "
132529|NCT01320475|"~     Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic~     and an opioid are generally associated to produce an epidural analgesia. However, opioid~     epidural administration is frequently associated with adverse effects as nausea, vomiting,~     urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an~     effective analgesic.~      The purpose of the study is to compare the epidural administration of levobupivacaine and~     sufentanil or the epidural administration of levobupivacaine associated with the iv~     administration of ketamine.~   "
132530|NCT01320462|"~     Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by~     varenicline and follow up by quit line) in the preoperative clinic is more effective than~     the simple preoperative smoking intervention (brief advice and provision of information~     about the quit lines ) in terms of short-term and long-term quit rates~      Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention~     (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in~     the preoperative clinic to help surgical patients quit smoking perioperatively and for the~     long-term.~   "
132531|NCT01320449|"~     Epo increases red blood cell production and hence the amount of oxygen that can be~     transported around the body. It is shown that prolonged use of synthetic Epo (rHuEpo) leads~     to an increase in the period of time a given physical work can be performed, therefore it~     will continue to be abused by athletes, especially in endurance sports.~      The existing method for measuring the abuse of rHuEpo approved by the World Anti-Doping~     Agency (WADA) is based on differences in the sugar groups bound to rHuEpo and Epo produced~     in the body, respectively.~      Proteomics is a method by which one can look at all the proteins in blood at the same time.~     Even proteins that have changed very little can be distinguished. The main objective of this~     project is to investigate the effect of prolonged treatment with rHuEpo on changes in blood~     proteins in healthy young men.~   "
133119|NCT01312857|"~     The purpose of this study is to see if Panitumumab plus the other treatments will increase~     the time of remission. Remission means that there is no sign of the cancer.~   "
132532|NCT01320436|"~     Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity~     in patients. The current standard treatment for mild to moderate UC (MTMUC) includes~     5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients~     continue to experience disease symptoms and flare-ups. These patients require higher dosages~     of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy~     which comprises higher risk of hazardous side effects.~      Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been~     extensively studied in the context of inflammatory diseases. In humans, a controlled study~     using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to~     placebo in maintaining remission in MTMUC patients . A small, preliminary open label study~     has also shown efficacy in reducing disease symptoms and inflammatory markers in this group~     of patients .~      This data provides bases for investigating an integrative approach to optimize the current~     standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA~     medication and curcumin could benefit this subgroup of patients and reduce morbidity and~     perhaps need for escalating pharmacological intervention.~   "
132533|NCT01320423|"~     To establish whether a policy of earlier surgical evacuation of the haematoma in selected~     patients with spontaneous lobar ICH will improve outcome compared to a policy of initial~     conservative treatment. The trial will also help to better define the indications for early~     surgery.~      This will overcome two of the criticisms of STICH (timing was too late and sometimes~     location was too deep). The subgroup identified in STICH is clinically sensible and the~     hypothesis identified for STICH II is in line with current neurosurgical opinion.~   "
132534|NCT01320410|"~     The study will comprise two dosing periods in two different cohorts of healthy volunteers.~     The investigators will begin with a single dosage period I (1 injection of 25 mg of~     Risperidone for each subject); single dosage period II, different from the previous one (1~     injection of 37.5 mg of Risperidone for each subject), in a second group of healthy~     volunteers different from the first group will not start until after a preliminary analysis~     has been made of the safety data and plasma concentration data are known for the formulation~     of prolonged release Risperidone using the ISM® technology.~   "
132535|NCT01320397|"~     The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more~     pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive~     patients carrying at least one of the pre-specified gene mutations. In previous studies has~     been demonstrated that these mutations are able to induce specific alterations inducing an~     increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial~     blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the~     impact of these alterations, and so directly reverse the increase in blood pressure.~   "
132536|NCT01320384|"~     The aim of the study is to compare, in patients with acute respiratory failure/acute lung~     injury the efficacy of three different methods of oxygenation to prevent endotracheal~     intubation :~        1. conventional oxygen therapy (O2 conventional)~        2. high flow nasal oxygen therapy (O2-HFN)~        3. association of high flow nasal oxygen therapy with non invasive positive pressure~          ventilation (O2-HFN/NPPV).~   "
132537|NCT01320371|"~     The purpose of this prospective study is determine if barbed sutures are more efficient,~     have comparable complication rates, clinical outcomes, and cosmesis outcomes versus~     traditional knotted sutures when used in the closure of primary total knee arthroplasty~     (TKA).~      Barbed suture has been associated with improved closure efficiency and safety in TKA in~     prior studies. The investigators performed a multicenter randomized controlled trial to~     determine the efficiency and safety of this technology in TKA. The investigators~     prospectively randomized 411 patients undergoing primary TKA to either barbed running~     (n=191) or knotted interrupted suture closure (n=203). Closure time was measured~     intraoperatively. Cost analysis was based on suture and operating room time costs.~   "
132538|NCT01320358|"~     The main purpose of this exploratory trial is to evaluate the reliability, safety and~     usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is~     given in combination with ECMPS 360 mg tablets in adult renal transplant recipients.~   "
132539|NCT01320345|"~     The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults~     with Type 1 diabetes mellitus who are at high risk of eye damage.~   "
132540|NCT01320332|"~     The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and~     tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.~   "
132541|NCT01320319|"~     Primary Aim is to test the Hypothesis: Nutritional supplementation with 960mg EPA three~     times a day positively affects muscle function and mass (assessed by muscle biopsies, assays~     of cellular aerobic function and DEXA scan) and inflammation (measuring cellular markers of~     inflammation) in patients undergoing resection of colorectal cancers.~      The secondary aim is to evaluate aerobic performance assessed by cardiopulmonary exercise~     testing (CPEX) and perioperative outcome in patients with colorectal cancer post surgical~     resection.~   "
132542|NCT01320306|"~     The prevalence rate of intracranial aneurysms in the adult population is close to 5%.~     Rupture risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most~     patients suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old.~     Aneurysmal SAH may cause disability and mortality. The present study includes a follow-up~     study and a cross-sectional fMRI study. The purpose of the follow-up study is to monitor~     patients receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine~     whether such treatment is associated with cognitive, psychosocial and/or neurologic sequela.~     The purpose of the cross-sectional fMRI study is to examine the relationship between memory~     function and brain activity among SAH patients. Memory impairment is often found among~     aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory~     impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.~   "
132543|NCT01320293|"~     Severe psoriasis has been demonstrated to be associated with decreased endothelial function~     and an increase risk of future coronary events. Although systemic therapy with~     immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on~     systemic inflammation and endothelial function are unknown.~      In this study we want to assess the cardiovascular risks factors, endothelial dysfunction~     and inflammatory markers before and after treatment of moderate to severe psoriasis with an~     FDA-approved biologic agent, adalimumab (Humira).~   "
132544|NCT01320280|"~     The purpose of this study is to find out what effects, good and/or bad, BIBW 2992 (Afatinib)~     has on patients and their advanced prostate cancer which does not respond to hormone or~     chemotherapy any more. Only patients with tumors which have an increased amounts of a~     protein called HER2 on their cell surface will be included.~      BIBW 2992 (Afatinib) is a drug which in advanced clinical testing in lung and breast cancer.~   "
132545|NCT01320267|"~     The investigators will document the success for completing laparoscopic resection of cancer~     in the right colon using a new single port access technique. The current procedure requires~     4 incisions for 4 separate ports. With technological advancement of newly designed~     instruments it is now possible to do the same laparoscopic procedure through a single port.~     The investigators want to demonstrate here in British Columbia that it is a safe procedure~     with similar success and outcomes compared to the standard 4-port laparoscopic operation.~      The investigators propose that this procedure may provide early discharge due to less pain~     and also be associated with less wound infection and hernia complications. The single~     incision will have improved cosmesis compared to the standard 4-port standard laparoscopic~     procedure.~   "
132546|NCT01320254|"~     The purpose of this study is to determine the efficacy of panitumumab plus~     cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract~     cancer patients without systemic pre-treatment, compared to the historical data and to the~     randomised control group without the antibody, which verifies the historically based~     assumption.~   "
132547|NCT01320241|"~     Malignant biliary obstruction is a common clinical condition caused by various malignancies.~     Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become~     the most important methods for relieving malignant biliary obstruction. However, the benefit~     for the survival of the patients with palliation of the stent treatment is limited because~     no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by~     the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded~     with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo~     evaluations for the delivery system, the investigators prospectively compare the responses~     to treatment with this radiation biliary stent, versus the conventional biliary SEMS in~     patient with malignant biliary obstruction.~   "
132548|NCT01320228|"~     The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and~     dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased~     fecal fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food~     intake, anthropometry, Quality of Life and cardiovascular risk markers will be evaluated.~     The trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in~     which 72 obese participants will be randomised to supplementation with flaxseed fibres~     and/or dairy calcium concentrate (Capolac) in addition to treatment with Alli ®:~        1. Alli® (60 mg t.i.d) plus placebo (rice flour)~        2. Alli® plus 5 g flaxseed fibers~        3. Alli® plus 1200 mg Ca from Capolac~        4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac~   "
132549|NCT01320215|"~     The primary objective of this study is to compare 30-day complication rates associated with~     promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic~     technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include~     comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality~     of life and medico-economic data between the two techniques.~   "
132550|NCT01320202|"~     The purpose of this study is to confirm the safety and efficacy of Soluble Ferric~     Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in~     anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy~     will be measured primarily by the change from baseline in hemoglobin (Hgb).~   "
132551|NCT01320189|"~     The objective of this study is to determine ad libitum daily energy and protein intake,~     energy balance and appetite profile in response to protein/carbohydrate and fat ratio over~     12 consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.~   "
132552|NCT01320176|"~     This study aimed to evaluate the safety and reactogenicity of two intramuscular injections~     of two different dosages of an investigational clade B HIV vaccine.~   "
132553|NCT01320163|"~     This study is designed to determine whether a functional difference exists between the~     laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received~     neuromuscular blockade.~   "
132554|NCT01320150|"~     Osteoarthritis (OA) is the single most common cause of disability in mid and late life.~     About 27 million people in the United States suffer from this incurable process and 10~     million have OA of the knee. Total knee replacement (TKR) is a reliable treatment option for~     patients disabled by knee OA who have failed non-operative treatment; 58% of these surgeries~     are performed on patients 65 years or older. Despite the overall success of TKR in most~     cases, persistent postsurgical pain (PPP) of the operated knee remains a common and often~     difficult to treat postoperative outcome affecting 13-20% of all patients at 6 months~     post-TKR, which amounts to 65,000-100,000 patients/year in the USA. Important secondary~     outcomes of PPP are restricted physical mobility and poor quality of life, especially in~     older patients.~      Recent findings spanning the pre-, intra- and postoperative periods suggest that the~     development of PPP after TKR is a multi-factorial process, comprised of both~     neurophysiologic and psychosocial factors. Likely determinates include preoperative thermal~     pain sensitivity, anxiety, pain catastrophizing; and postoperative area of secondary~     mechanical hyperalgesia or hypoalgesia (numbness). There is already agreement that the~     intensity of early (acute) postoperative pain is one of the factors predicting PPP. To date,~     most studies have examined the role of risk factors in isolation and/or within a single~     domain, and no prospective study has comprehensively evaluated the interaction of~     neurophysiologic and psychosocial variables in the evolution of PPP following TKR. The lack~     of information regarding how neurophysiologic pathways and patient cognitive/affective~     states interact over time following otherwise successful TKR has greatly undermined the~     understanding of PPP after TKR.~      The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs~     undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and~     postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were~     selected because they are potentially modifiable, and therefore may be amenable to~     intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The~     proposed multi-factorial and prospective approach to investigating risk factors is a vital~     next step towards understanding the complex phenomenon of PPP.~   "
132555|NCT01320137|"~     The purpose of this study is to develop and characterize immunological assays on blood~     samples.~   "
132659|NCT01318785|"~     Examination of therapeutical effects of different types of armsleeves in treating lymphatic~     diseases after breast cancer surgery during maintenance phase~        1. thesis:~           - all types should be equal regarding volume reduction~        2. thesis: armsleeves manufactured with microfibre yarn are expected to be~             -  better in wearing comfort and~             -  better in handling features.~   "
132556|NCT01320124|"~     A contracture is a pathological condition limiting range and function of joints.~     Contractures of large and small joints alike will affect one's ability to independently~     perform daily activities such as eating, dressing or walking. Current treatments for~     contractures include physical stretching, the use of assistive devices or, rarely, surgery.~     Despite prolonged treatments, patients with contractures rarely regain complete mobility.~     Progress in preventing and treating contractures will be possible only through an~     understanding of the biological and molecular processes involved. Our group has established~     and validated an animal model to study the histological events and the molecular mechanisms~     involved in joint contractures. We have provided evidence for capsule stiffness,~     characterized cartilage degeneration, and identified four genes whose expression is altered~     in the cartilage of a knee joint with contracture. The work we propose in the current study~     aims at finding genes and pathways in the joint capsule associated with knee joint~     contractures. The results will identify new avenues for treating the large number of~     patients suffering from contractures.~   "
132557|NCT01320111|"~     AIM OF STUDY~      Primary Efficacy Variable:~      The primary study objective is the proof of efficacy, measured by progression free survival~     (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer.~      Progression-free survival (PFS) is defined as the time from randomisation to disease~     progression or death.~      Secondary Efficacy Variables:~        -  Clinical benefit (CR+PR+SD)~        -  ORR (CR+PR)~        -  Time to progression~        -  Time to next Treatment (TTT)~        -  Overall survival~        -  Safety profile~   "
132558|NCT01320098|"~     The purpose of this research is to evaluate and compare the effectiveness of two parenting~     programs in reducing the ADHD symptoms and behavioral problems of preschool children with~     ADHD through a controlled study. One program is a home-based parent training intervention~     that is designed to enhance the parent-child interaction, constructive parenting skills, and~     the child's tolerance for delay. The other intervention is a clinic-based parent training~     program that focuses on reducing noncompliance in preschool children and improving parenting~     skills.~      Both programs consist of private weekly parenting sessions with Clinical Psychologists -~     once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior~     modification as a means of improving oppositional and non-compliant child behavior. Both~     interventions also involve procedures that focus on improving children's attention.~      Neither program involves medication, and all families will receive one of the two parenting~     programs being evaluated. Study evaluations, as well as participation in the parenting~     programs, are provided at no cost to families. Evaluation and parenting sessions can be~     scheduled at times convenient to families.~   "
132559|NCT01320085|"~     The study will assess the safety and efficacy of single-agent MEK162 in adult patients with~     locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring~     BRAFV600E or NRAS mutations.~   "
132560|NCT01320072|"~     To diagnose aspirin hypersensitivity in asthmatics by using and safe, low-dose aspirin oral~     challenge.~      Hypothesis 1: A low dose of oral ASA (20 or 40 mg) will induce significantly different~     concentrations of arachidonic acid metabolites in ASA-sensitive asthmatics as compared to~     ASA-tolerant asthmatics.~      Hypothesis 2: The low dose (20 or 40 mg) ASA challenge will be well tolerated by~     ASA-sensitive asthmatics.~   "
132561|NCT01320059|"~     The goal of this clinical research study is to learn if an imaging solution called~     18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans.~     The safety of the solution and how the solution is processed by your body will also be~     studied.~   "
132562|NCT01320046|"~     Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning~     or irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in~     the general population is unknown.~      Contact dermatitis is an inflammation of the skin resulting from an external agent that acts~     as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic,~     resulting from prolonged exposure to weak irritating substances.~      The most common form of VCD is irritant contact dermatitis, and it usually presents as~     vulvar itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin~     to irritants compared to other body parts, decrease in the skin barrier function due to~     exposure to sweat, urine and vaginal discharge and constant friction of the vulvar area. In~     menopausal women, lack of estrogen contributes to tissue atrophy and thinning, and may~     increase the effect of irritants on the vulvar skin.~      One of the most common irritating substances that cause VCD is urine. The phenomenon of~     urine-induced VCD is known as diaper rash in babies, and it was also described in~     bedridden patients using diapers constantly. Women with urine incontinence (UI), a problem~     that its prevalence in women increases with aging, may use constantly panty liners or pads~     to prevent urine leakage. The urine is being absorbed in the pad, and the vulvar skin is~     continually exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of~     this phenomenon in the general population is unknown.~      The patients complain of itch, burning or irritation of the vulvar skin, and on exam~     erythema, edema and irritated skin are found. As most patients do not connect between UI to~     their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar~     symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the~     vulvar complaints is not recognized, patients do not receive proper treatment that requires~     primary management of UI.~      The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize~     risk factors for UI induced VCD.~   "
132563|NCT01320033|"~     The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for~     16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation~     Carry Forward, Intent To Treat) in inflammatory lesion counts.~   "
132564|NCT01320020|"~     The study is designed as an open-label dose-escalation study to investigate the safety and~     tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for~     dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4~     single i.v. administrations of catumaxomab followed by 1 week for safety observations after~     each administration. All patients will be offered continuation of catumaxomab treatment at~     the same dose until disease progression or death, whichever occurs first.~   "
132574|NCT01319890|"~     Current evidence regarding the optimal surgical approach to potentially curable right~     colonic cancer is based on numerous, well designed randomised controlled clinical trials.~     Currently, eminence based opinion suggests that an alternative surgical technique, single~     incision laparoscopic surgery (SILS), may improve short and long term outcomes after~     minimally invasive right colonic resection. A true, prospective analysis comparing standard~     of care (laparoscopic right hemicolectomy) and this new therapy(SILS) has yet to be~     published. Having established the optimum treatment modality the minimally invasive approach~     to right colonic tumors the results will be communicated at national and international~     meetings.~   "
132575|NCT01319877|"~     This observational study will evaluate the safety and efficacy of Bevacizumab in combination~     with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese~     participants with metastatic colorectal cancer. Data will be collected from each participant~     for up to 3 years.~   "
132565|NCT01320007|"~     Heart failure is a major clinical problem that is increasing in magnitude and the cost of~     management of heart failure is escalating. A significant part of this cost is related to~     unplanned acute presentation to emergency departments and hospitalisation with worsening~     shortness of breath due to increased fluid content in the lungs.~      Many heart failure patients are already fitted with defibrillators to protect them from the~     risk of fast heart rhythms and sudden death and are followed up in both the heart failure~     clinics and defibrillator clinics. Recently some of the defibrillators fitted have been~     equipped with an extra function that can detect and warn of changes in the fluid content of~     the lungs very early even before the patient starts to complain of any shortness of breath~     and before any signs of fluid overload are seen clinically. However, it is not known how to~     deal with these warnings if they occur very early and it is not known whether a medical~     intervention at his stage is beneficial to prevent progression and eventual hospital~     admission. In the majority of cases, early warnings of this kind are ignored or this~     function is disabled at implantation of the device.~      The current study will involve patients who have already been fitted with a device with the~     above capability. The investigators will use the new function to guide management of these~     patients and compare their outcome with similar patients who are fitted with devices without~     it. The investigators will attempt to manage early warnings by a predetermined increase in~     medications in a group of patients and compare their clinical course to a similar group in~     whom no action is taken.~   "
132566|NCT01319994|"~     According to current estimates, nearly 1% of the general population is treated with~     long-term glucocorticoids. Chronic hypercortisolism leads to a phenotype that resembles the~     metabolic syndrome. The investigators have shown that inhibition of~     adenosine-monophosphate-activated protein kinase (AMPK) activity in adipose tissue plays a~     role in corticosteroid-mediated insulin resistance. Metformin, one of the mainstay therapies~     for type 2 diabetes, is a known activator of AMPK, which mediates its beneficial effects on~     glucose and lipid metabolism. The investigators have shown in an animal model that metformin~     - via altering AMPK activity - prevents the development of the metabolic complications of~     glucocorticoid excess, and the investigators wish to confirm this in a human study. The aim~     of this prospective, randomised, double-blind, placebo-controlled study is to investigate~     the effect of metformin treatment on metabolic parameters in patients on long-term high-dose~     glucocorticoids. The study is part of the investigators translational project and could~     rapidly lead to immediate patient benefit, improving quality of life and reducing health~     care costs for the NHS.~   "
132567|NCT01319981|"~     The goal of this clinical research study is to learn if intensive chemotherapy (hyper-CVAD~     therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab~     for patients who are CD20 positive and/or imatinib or dasatinib for patients with the~     Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety~     of this treatment will also be studied. CD20 is a protein marker that is found in leukemia~     or lymphoma cells.~   "
132568|NCT01319968|"~     Postpartum dyspareunia (PD) is a recognized phenomenon: it is estimated that 50-60% of women~     have dyspareunia 6 to 7 weeks following delivery, and 33% and 17% will still report pain~     during intercourse three and six months after delivery, respectively.~      Studies that evaluated the prevalence and the causes for PD referred primarily to obstetric~     trauma, such as vaginal tears, episiotomy, the mode of repair and damage to the pelvic floor~     muscles as probable causes for PD. These studies did not refer to estrogen deficiency and~     the possible effect of breastfeeding on vaginal atrophy and its contribution to PD.~     Comparison between vaginal deliveries and cesarean sections revealed that there is no~     difference in the prevalence of PD between the two groups, and according to these findings~     it can be assumed that the mechanical trauma to the vagina and pelvic floor during delivery~     is not the main cause for the development of PD.~      Vaginal atrophy due to estrogen deficiency is a common cause for postmenopausal dyspareunia.~     With estrogen deficiency, profound changes occur in the vagina: vaginal mucosa becomes thin~     and pale or hyperemic and loose her flexibility. Blood flow decreases, normal vaginal~     discharge is reduced, and maturation of epithelial cells do not take place in the absence of~     estrogen. Women with estrogen deficiency may complain of dryness, pruritus, irritation,~     burning, dysuria, pain and dyspareunia. These changes are reversible by estrogen, given~     systemically or topically, and cause resolution of clinical findings, as well as~     disappearance of symptoms in several weeks.~      Similar to postmenopausal patients, breastfeeding women immediately after delivery,~     experience decline of estrogen levels, and this decline may persist as long as lactation is~     continued. Therefore, many women after delivery may experience vaginal atrophy due to~     transitional lack of estrogen. It is possible that this atrophy is the cause for the high~     rate of PD.~      Our clinical experience shows that many women present with postpartum dyspareunia with~     vaginal atrophy, and that vaginal atrophy is responsible for part or most of their~     complaints. Although most gynecologists recognize atrophy easily in menopausal women,~     vaginal atrophy is not recognized correctly in most puerperal patients and therefore do not~     receive attention and proper treatment.~      The aim of the study is to characterize the phenomenon of postpartum vaginal atrophy in~     terms of prevalence, risk factors and duration, and the association between vaginal atrophy~     and postpartum dyspareunia.~      We also intend to evaluate the effect of vaginal treatment with estriol cream 0.1% (Ovestin~     cream) on postpartum dyspareunia.~      The study will expand our knowledge regarding postpartum dyspareunia and will enable~     formulating recommendations for evaluation and treatment of PD.~   "
132569|NCT01319955|"~     Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that~     influenza has a substantial association with pneumonia among children less than two years~     old. This study will use commercially available trivalent inactivated vaccine (killed~     vaccine) to see if it can prevent early childhood pneumonia among children less than two~     years old. The study will vaccinate children across three seasons (3 years), and look at the~     effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed~     influenza. It will also look at the effect on laboratory-confirmed influenza illness among~     the non-vaccinated household contacts of all ages of these children.~   "
132570|NCT01319942|"~     This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with~     locally advanced hepatocellular carcinoma.~   "
132571|NCT01319929|"~     To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of~     LY2828360 in male and female subjects with osteoarthritic knee pain~   "
132572|NCT01319916|"~     Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous~     Injection of ATX-101 into Abdominal Fat Tissue~   "
132573|NCT01319903|"~     The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory~     response to various stimuli in humans and espacially during sepsis. Purpose of this phase I~     clinical trial in healthy human males is to investigate various parameters concerning safety~     and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.~   "
132584|NCT01319760|"~     A prospective, randomized, controlled multi-site feasibility trial to assess the potential~     role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation~     myocardial infarction (STEMI)~   "
132712|NCT01318070|"~     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily~     (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled~     blood glucose.~   "
132576|NCT01319864|"~     In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different~     dose levels, used together with other anti-cancer drugs—cytarabine and etoposide. We want to~     find out what effects, good and /or bad, this combination of drugs has on leukemia.~     Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from~     staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA~     approved for mobilizing stem cells from the bone marrow in preparation for an autologous~     stem cell transplant. Cytarabine and etoposide have been used as part of standard~     chemotherapy for ALL and AML. However, the use of plerixafor with cytarabine and etoposide~     in pediatric patients with relapsed or refractory ALL, AML and MDS is considered~     experimental.~   "
132577|NCT01319851|"~     Allogeneic blood and marrow transplantation remains the only viable cure for children who~     suffer from many serious non-malignant hematological diseases. Transplantation, however,~     carries a high risk of fatal complications. Much of the risk stems from the use of high dose~     radiation and chemotherapy for conditioning, the treatment administered just prior to~     transplant that eliminates the patients' marrow and immune system, effectively preventing~     rejection of the donors' cells. Attempts to make blood and marrow transplantation safer for~     children with non-malignant diseases by using lower doses of radiation and chemotherapy have~     largely failed because of a high rate of graft rejection.~      In many such cases, it is likely that the graft is rejected because the recipient is~     sensitized to proteins on donor cells, including bone marrow cells, by blood transfusions.~     The formation of memory immune cells is a hallmark of sensitization, and these memory cells~     are relatively insensitive to chemotherapy and radiation. Alefacept, a drug used to treat~     psoriasis, on the other hand, selectively depletes these cells. The investigators are~     conducting a pilot study to begin to determine whether incorporating alefacept into a low~     dose conditioning regimen can effectively mitigate sensitization and, thereby, prevent~     rejection of allogeneic blood and marrow transplants for multiply transfused children with~     non-malignant hematological diseases.~   "
132578|NCT01319838|"~     Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related~     deaths in children. With the advancement of treatment therapies, the long term survival rate~     has progressed to approximately 50%. The therapy used for treatment, however, is very toxic~     and associated with serious long-term side effects. Treatment for neuroblastoma typically~     includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and~     immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the~     drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments~     and helps turn the remaining cancer cells into normal nerve cells.~      Most patients often respond to this treatment at first but are at a high-risk for the cancer~     coming back. The majority of the children who relapse after treatment or develop recurrent~     disease do so in the first two years following the completion of therapy and there are no~     current treatments to cure those who relapse. This study will explore whether or not~     extending the therapy with isotretinoin from 6 months to 24 months will help prevent the~     cancer from coming back without causing severe side effects.~   "
132579|NCT01319825|"~     This is an open label pilot study to determine whether milnacipran can reduce headache~     frequency in episodic and chronic migraine sufferers.~   "
132580|NCT01319812|"~     The objective of this study is to separately demonstrate the safety and efficacy of~     BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of~     femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal~     popliteal artery (PPA), while the Astron stent will be used for the treatment of the common~     or external iliac artery lesions.~   "
132581|NCT01319799|"~     The use of MRI have shown that the incidence of postoperative cerebral lesions due to~     cerebral embolization is high (1). Nonetheless the extent of postoperative neurological~     dysfunction is only a fraction of the actual amount of new postoperative changes detected on~     MRI. Transcranial Doppler (TCD) has shown the occurrence of extensive microembolic signals~     in intracerebral arteries during open heart procedures (2). The clinical significance of~     cerebral microemboli is not clear (3-5). The use of serological markers to assess cerebral~     injury after open cardiac surgery is difficult to interpret. The levels of markers seems to~     be contaminated from extracerebral sources (6). In order assess the release of markers of~     neuronal damage after open aortic valve surgery the investigators intend to examine the~     levels of S-100B, NSE and Tau in cerebrospinal fluid (CSF) by comparing the levels~     preoperative with the levels one day after surgery. Furthermore the investigators will~     determine the total amount of cerebral microembolic signals during the surgical procedure by~     means of TCD. The investigators will statistically test if there is any correlation between~     the increase in cerebrospinal fluid levels of S-100B,NSE and Tau and the cerebral embolic~     load.~   "
132582|NCT01319786|"~     Previous work has shown that increasing fruit and vegetable intake in patients with high~     blood pressure improves cardiovascular function. Research indicates that this may be partly~     owing to compounds called polyphenols, which are found in abundance in fruits and vegetables~     and other foods such as wine, tea and dark chocolate. The investigators now wish to test if~     consuming fruits and vegetables (including berries which are very rich in polyphenols), as~     well as dark chocolate, has further benefits for cardiovascular function. A total of 110~     subjects with high blood pressure will be recruited and asked to follow a low polyphenol~     diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four~     weeks (a washout period). They will then be randomised to continue this diet or to consume 6~     portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark~     chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free~     of charge and delivered to the homes of the participants who are randomised to the high~     fruit and vegetable arm of the study.~      Assessment of microvascular and platelet function will be undertaken before and after~     consuming this diet. Improvements in these tests of cardiovascular function have previously~     been linked to reduced risks of heart disease in people with high blood pressure. This study~     will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of~     developing heart disease.~   "
132583|NCT01319773|"~     This study will evaluate the safety, tolerability and pharmacokinetics of two formulations~     of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The~     parallel-group phase will be followed by a paired-eye phase which will evaluate the safety~     and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with~     cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.~   "
132585|NCT01319747|"~     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and~     surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or~     even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically~     paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both~     interventions are limited.~      The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary~     objectives are to compare the duration of hospitalization, quality of Life, cost and to~     compare the satisfaction of the patients.~   "
132586|NCT01319734|"~     Null hypothesis:~      No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular~     complications of type 2 Diabetes Mellitus (DM).~      Alternative hypothesis:~      There is a significant effect of vitamin C 500mg supplementation on the severity of the~     micro-vascular complications of type 2DM.~   "
132587|NCT01319721|"~     To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane~     graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium~     removal in patients with recurrent pterygium.~   "
132588|NCT01319708|"~     The investigators will examine the balance between IVF success in terms of outcome~     parameters, using a mild ovarian stimulation protocol, opposing it to the conventional~     stimulation regimens in poor responders undergoing IVF.~   "
132589|NCT01319695|"~     The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as~     compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation~     protocols in women undergoing in vitro fertilisation.~   "
132590|NCT01319682|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous~     lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar~     fusion.~      A total of 54 patients will be randomized into one of two groups (group C or group I) based~     on Excel number generation.~      Patients in group C will receive received normal saline intravenous injection, and patients~     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a~     continuous lidocaine infusion of 2 mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,~     24, 48 hours postoperatively.~   "
132591|NCT01319669|"~     To assess the efficacy and safety of administration of rhTPO at different time in the~     treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung~     cancer (NSCLC)~   "
132592|NCT01319656|"~     The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently~     integrate rehabilitation services into primary care settings, which would be the reference~     point in the health care system for people with Chronic diseases (CD). More specifically,~     the intervention will aim to: (1) clinically operationalize the mechanisms and tools~     necessary for delivery of integrated CD services, promoting continuity of care in response~     to the needs expressed by stakeholders; (2) implement and deploy rehabilitation services~     adapted to the realities of various clinical primary care settings and develop tools to~     ensure the sustainability of interventions beyond the rehabilitation period; and (3) support~     clinical primary care teams in the acquisition and maintenance of evidence-based practices~     for the targeted CDs.~   "
132593|NCT01319643|"~     Oxygen administration is a common practice in intensive care units, although concern is~     growing about oxygen toxicity. The aim of the study is to access whether a rigorous~     maintenance of a state of normal oxygenation in critically ill patients could obtain better~     outcomes, such as mortality, infections and organ failures, in comparison to conventional~     oxygen therapy practice.~   "
132594|NCT01319630|"~     Major microvascular blood flow alterations have been documented in patients with severe~     sepsis. It was also demonstrated that the microcirculation improved in survivors of septic~     shock but failed to do so in patients dying from acute circulatory failure or with multiple~     organ failure after shock resolution. Early, effective fluid resuscitation is a key~     component in the management of patients with severe sepsis and septic shock with the goal of~     improving tissue perfusion. The best fluid in this early resuscitation phase has been and~     still is under debate. The aim of this study is to evaluate the effect of Three different~     Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic~     shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy~     (NIRS) analysis.~   "
132595|NCT01319617|"~     The purpose of this investigation is to study the safety and tolerability of SENSIMED~     Triggerfish, a soft contact lens-based device intended to continuously record relative~     changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and~     glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an~     ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24~     hours and side effects are the main endpoints of the investigation.~   "
132596|NCT01319604|"~     The purpose of the investigation is to investigate the relationship between the study device~     output and tonometric assessments.~   "
132597|NCT01319591|"~     The purpose of this study is to compare different estimates of calculating creatinine~     clearance by mathematical formula and compare them to creatinine clearance based on a timed~     urine collection in patients who received high-dose methotrexate for the treatment of~     primary CNS lymphoma or CNS involvement of systemic lymphoma.~   "
132598|NCT01319578|"~     The specific purpose of this study is to describe the characteristics of the K2CG chewing~     gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing~     in relation to a meal, and dose of K2CG chewing gum.~   "
132610|NCT01319422|"~     Lenalidomide has clinical activity in myeloma. The closely related compound, Pomalidomide,~     may have clinical activity in patients who have previously been treated with lenalidomide~     and who no longer respond to it. The mechanism of anti-tumor effects of these drugs has been~     attributed to several effects including anti-angiogenesis, immune activation, and~     anti-proliferative effects. Recent studies have suggested that these agents can mediate~     surprisingly rapid biologic effects on human monocytes and T cells. Our hypothesis is that~     the proximate effects of these drugs will be sensitive and quantitative surrogates of~     subsequent effects including activation of tumor antigen specific T cells as well as innate~     immune cells. Understanding the correlation between the pharmacodynamics of these effects~     with downstream activation using quantitative assays will facilitate the rational~     development of pomalidomide as immune-modulatory drug in diverse settings as well as its~     optimal development in myeloma therapy.~   "
132599|NCT01319565|"~     Background:~      - An experimental treatment for metastatic melanoma involves cell therapy, in which~     researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the~     laboratory in large numbers, and then use the cells to attack the tumor tissue. Before~     receiving the cells, chemotherapy is needed to temporarily suppress the immune system to~     improve the chances that the tumor-fighting cells will be able to survive in the body. In~     some studies of cell therapy, individuals who have received total body irradiation (TBI) in~     addition to the chemotherapy (in order to increase the length of time that they do not~     produce white blood cells) seem to have a slightly better response to the treatment, but it~     is not known if adding radiation to the cell therapy will cause a better response for all~     individuals. Researchers are interested in comparing cell therapy given with the usual~     chemotherapy to cell therapy given with the usual chemotherapy and TBI.~      Objectives:~      - To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given~     with chemotherapy and total body irradiation in individuals with metastatic melanoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and tumor imaging studies.~        -  Participants will be divided into two groups: cell therapy with chemotherapy alone~          (group 1) or cell therapy with chemotherapy plus TBI (group 2).~        -  All participants will provide a tumor sample from either surgery or a tumor biopsy for~          white blood cell collection.~        -  Participants will have leukapheresis to collect additional white blood cells for cell~          growth and future testing, and TBI group participants will also provide stem cells to~          help them recover after radiation. (TBI participants who cannot provide enough stem~          cells will be moved to the non-radiation treatment group.)~        -  Participants will have chemotherapy with cyclophosphamide (two treatments over 2 days)~          and fludarabine (five treatments over 5 days) starting 7 days before the cell therapy.~          Participants in the TBI group will also have TBI for the 3 days immediately before the~          cell therapy.~        -  All participants will receive the white blood cells, followed by high-dose aldesleukin~          every 8 hours for up to 5 days after the cell infusion to help keep the therapy cells~          alive and active. Participants will also have injections of filgrastim to stimulate~          blood cell production, and participants in the TBI group will also receive their stem~          cells.~        -  Participants will take an antibiotic for at least 6 months after treatment to prevent~          pneumonia, and will be asked to return for regular monitoring and followup visits for~          at least 5 years to evaluate the tumor s response to treatment....~   "
132600|NCT01319552|"~     Packed red blood cell units destined for transfusion can be stored for up to 42 days prior~     to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies~     suggest that certain patients transfused with blood stored for longer duration have poorer~     outcomes than patients transfused fresher blood. The investigators' hypothesis is that the~     delivery of an immediate and substantial load of hemoglobin-associated iron from a stored~     unit of blood leads to changes that explain the differences in outcome between patients~     transfused old versus fresh blood. The investigators propose to test this hypothesis in~     humans by transfusing an individual's own blood, both fresh and after storage, and comparing~     levels of various outcome measures.~   "
132601|NCT01319539|"~     This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with~     stage I-III breast cancer that can be removed by surgery. Akt inhibitor MK2206 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
132602|NCT01319526|"~     RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment~     with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of~     therapy on HIV.~      PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV~     infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.~   "
132603|NCT01319513|"~     Protein ingestion increases the rate at which the body builds new proteins in skeletal~     muscle (muscle protein synthesis. This study is designed to examine how the pattern of~     feeding affects muscle protein synthesis following resistance exercise. There is reason to~     believe that the large rapid increase in blood amino acid concentrations that accompanies~     the ingestion of a bolus of protein is important to increasing muscle protein synthesis.~     Thus, we hypothesize that the consumption a bolus of protein will elevate muscle protein~     synthesis to a greater extent than the consumption of an equivalent amount of protein that~     is consumed in small divided doses.~   "
132604|NCT01319500|"~     This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia.~     Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.~   "
132605|NCT01319487|"~     The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low~     dose) administered in the eye are more effective than placebo in treating patients with~     diabetic macular edema, following 12 weeks of treatment.~   "
132606|NCT01319474|"~     This study seeks to determine the rate of thromboembolic complications (blood clots),~     including death attributed to thromboembolic disease, when anticoagulation (blood thinner)~     therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a~     whole-leg compression ultrasound shows no DVT. Patients are followed for three months after~     the ultrasound to determine if a blood clot is diagnosed during that time.~   "
132607|NCT01319461|"~     Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5~     intraarticular injections at weekly intervals, for the sustained relief of pain and~     amelioration of joint dysfunction in patients of OA of the knee.~   "
132608|NCT01319448|"~     Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily~     proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current~     policy is not effective due to poor compliance and drug resistance. Intermittent treatment~     with a long acting drug regimen administered under supervision at clinic visits may be more~     effective. The aim of this trial is to compare the tolerability and acceptability of~     supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine~     (SP+AQ) or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and~     seventy patients with sickle cell disease attending the paediatric sickle cell disease~     clinic in Ilorin hospital who meet the eligibility criteria and have parental consent, will~     be randomized to one of three prophylactic regimens: daily proguanil, bimonthly~     sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate.~     Patients will be asked to return to clinic every two months and whenever they are sick. At~     enrollment, the study paediatrician will conduct a physical examination of the child, and~     collect a venous blood sample for a complete blood cell count and biochemical screen,~     determination of G6PD genotype, preparation of blood smears for malaria microscopy and a~     blood spot for determination of molecular markers of resistance. Four days after each clinic~     visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic)~     to ask about compliance and adverse events. Participants will be followed for one year. The~     parents or carer will be encouraged to bring their child to the Outpatient Department clinic~     if the child becomes unwell. The primary outcome of the trial is tolerability, secondary~     outcomes are adherence to the regimen, and incidence of malaria and the number of~     hospitalizations over 12 months. If the bimonthly regimens are well tolerated and the~     preliminary data from this study are promising, a larger multicentre trial will be required~     to determine efficacy.~   "
132609|NCT01319435|"~     Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term~     safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.~     Objectives: To evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and~     young infants (24 - 52 weeks postmenstrual age) with suspected or proven Gram Negative~     infection.~      To evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and~     young infants with suspected (or proven) Gram Negative infection.~      To describe the clinical outcomes of neonates treated with ciprofloxacin~   "
133194|NCT01311622|"~     The purpose of this study is to determine whether fostamatinib influences the plasma~     concentration of warfarin and changes its blood thinning effect, and to investigate how safe~     and tolerable it is when administered with warfarin.~   "
132611|NCT01319409|"~     The purpose of this double-blind, randomized clinical trial to compare outcomes of~     single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that~     anatomically reconstructing both bundles of the ACL will lead to better restoration of~     healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome~     measures, we will utilize a unique combination of high-speed biplane radiography (for highly~     accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and~     cartilage morphology) to characterize joint kinematics and cartilage surface interactions~     during functional tasks.~      The specific aims of this study are to:~      Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal~     dynamic knee function better than single-bundle ACL reconstruction.~      Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more~     similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as~     measured with dynamic stereoradiography 6 and 24 months after surgery.~      Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic~     double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as~     measured with dynamic stereoradiography.~      Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better~     clinical outcomes than single-bundle ACL reconstruction.~      Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical~     laxity and better range of motion and hop test scores in comparison to single-bundle ACL~     reconstruction.~      Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL~     reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a~     higher level of activity and more complete return to sport.~      Successful completion of these aims will provide quantitative evidence of the efficacy of~     anatomic double-bundle ACL reconstruction for restoring normal knee mechanics. Should the~     results show a clear benefit for this procedure, it would provide support for wider~     adaptation of anatomic DB reconstruction. By completing the proposed aims, we will also~     establish a sound basis for additional studies with longer follow-up (including the subjects~     in this cohort), to assess the benefits of anatomic DB ACL reconstruction for improving~     long-term clinical outcomes and maintaining joint and cartilage health.~   "
132612|NCT01319396|"~     The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing~     frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy~     device on 20+ human volunteers. This is being carried out in support of a 510(k) submission.~   "
132613|NCT01319383|"~     The purpose of this study is to compare HIV RNA expression and infection within resting~     (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to~     Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short~     interval exposure to VOR dosed over several weeks.~      Hypotheses:~        1. The frequency of resting CD4+ T cell- associated HIV RNA (RCVL) will be increased~          following single and repeated exposure to VOR when given at appropriate intervals, and~        2. That repeated exposure to VOR will reduce the frequency of HIV infection within resting~          CD4+ T cells (RCI)~   "
132614|NCT01319370|"~     The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical~     Foam (MTF) formulation compared to placebo in the temple region of male patients with~     androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and~     safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2~     years. Objective and subjective efficacy measures will be compared to baseline. Moreover,~     all patients will get the equal treatment and measurements in the vertex region to enable~     comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline~     but also to vertex region. Additionally safety assessments will be performed throughout the~     whole study.~   "
132615|NCT01319357|"~     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide. Currently~     available therapies for type 2 diabetes have various limitations and are associated with~     increased risk of hypoglycemia, weight gain, gastrointestinal side effects or edema and~     heart failure.~      A new and promising class of drugs are the gliptins. Several efficacy studies demonstrated a~     significant improvement of HbA1c with gliptins. In addition, gliptins improved fasting as~     well as prandial glucose levels and did not induce weight gain. Due to these positive~     metabolic effects in combination with a very small spectrum of side effects gliptins might~     very well be part of the standard therapy for type 2 diabetes in the future.~      Apart form surrogate parameters like reduction of fasting and postprandial blood glucose~     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function~     and cardiovascular outcome has not been the primary focus of current studies. Diabetes~     mellitus is strongly associated with microangiopathy and macroangiopathy and is a strong~     independent risk factor for cardiovascular disease and cardiovascular mortality. Endothelial~     dysfunction which plays a crucial role in the atherosclerotic process is commonly observed~     in patients with diabetes mellitus and already prediabetes and has - amongst other factors -~     been linked to fasting and postprandial hyperglycemia. Taken into account that gliptins~     reduce hyperglycemia and hyperglycemic peaks by preventing inactivation of GLP-1, which~     exerted beneficial effects on the endothelium in previous studies it is of major interest~     whether therapy with gliptins improves endothelial function.~   "
132616|NCT01319344|"~     Patients with the metabolic syndrome (MetSyn) are at increased risk for cardiovascular~     mortality and morbidity.This increased cardiovascular risk is attributed to metabolic~     dysregulations like impaired glucose tolerance or diabetes mellitus and dyslipidemia,~     abdominal obesity and arterial hypertension, which promote oxidative stress and inflammation~     with consecutive endothelial dysfunction causing an atherogenic environment.~      Aldosterone promoted end organ damage is mainly found in the cardiovascular system and the~     kidney. Inflammation and activation of different factors promotes fibroblast growth and~     matrix production resulting in myocardial fibrosis, vascular remodelling and renal fibrosis.~      MetSyn and aldosterone are cardiovascular risk factors and it is of crucial importance to~     note that there is a connection between MetSyn and aldosterone. Other cross sectional~     studies show a direct correlation of aldosterone levels and impaired glucose metabolism in~     patients with and without the MetSyn. Taken together, aldosterone influences essential~     parameters of the MetSyn. Coincidentally parameters of the MetSyn are stimulus for an~     increased aldosterone synthesis, i.e. visceral adipocytes.~      In large scale clinical trials - RALES, EPHESUS, 4E - inhibition of MR has proven to be~     beneficial in patients with congestive heart failure and post myocardial infarction and this~     result has been confirmed for diabetic patients, who are known to have an increased~     cardiovascular risk.~      There is only very limited data on the impact of MR inhibition on metabolic, endocrine, and~     inflammatory parameters in patients with MetSyn, who have not yet suffered from~     cardiovascular events.~   "
132617|NCT01319331|"~     The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP)~     will preserve beta-cell function and help slow the progression of type 1 diabetes.~   "
132618|NCT01319318|"~     This study will evaluate the degree of post-operative ocular inflammation in patients who~     are undergoing a pars plana vitrectomy.~   "
132619|NCT01319305|"~     This is a long-term follow-up of patients that participated in the BREATHE I study.~   "
132658|NCT01318798|"~     Post-operative acute renal failure is a severe post-operative complication and is associated~     with high mortality. The enhanced prediction score, including pre-as well as intra-operative~     predictors accurately predicted ARF following hepatic surgery. This prediction score allows~     early identification of patients at high risk of ARF and may support decision-making for~     protective kidney treatment.~   "
132620|NCT01319292|"~     Asthma is the most common chronic respiratory disease in children and has much effect on~     their life and study, which leads to huge economic burden and pressure to the whole~     families. Some children will develop into adult patients so that asthma can be the life-long~     vigorous trouble. In recent years, the prevalence rate of children asthma is increasingly~     going up worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom,~     Australia, New Zealand was between 12% to 30%.~      Center for Asthma Prevention and Education of Capital Institute of Pediatrics investigated~     the national asthma prevalence in 900 thousands children in 27 provinces and cities, which~     average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31~     provinces(43 cities) and the average national children asthma prevalence rate was~     1.97%(0.25% to 4.63%) which was much higher than that in 1990.~   "
132621|NCT01319279|"~     The purpose of this study is:~        1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in~          subjects with moderate hepatic impairment and in subjects with normal hepatic function.~        2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release~          tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic~          function.~   "
132622|NCT01319266|"~     The purpose of this study is to assess the effect of varying degrees of renal impairment~     (mild, moderate, severe and end stage renal disease) compared with subjects with normal~     renal function on the pharmacokinetics of the hydrocodone bitartrate extended-release~     tablet.~   "
132623|NCT01319253|"~     This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and~     laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that~     alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that~     alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic~     Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model~     biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing~     clinical and microbiological parameters.~   "
132624|NCT01319240|"~     This trial is conducted in Europe. The aim of this trial is to compare the bioavailability~     of insulin degludec and liraglutide, when administered either combined or as separate~     administrations.~   "
132625|NCT01319227|"~     This is a randomized clinical trial comparing two different uncemented femoral stems and two~     different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and~     clinical evaluation.~      Hypothesis:~        1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur~          than a conventional uncemented stem.~        2. An uncemented acetabular component with a backside of three-dimensional Titanium porous~          construct gives less periprosthetic bone resorption than a backside covered with a~          conventional porous coating with Titanium-beads and a hydroxy-apatite layer.~   "
132626|NCT01319214|"~     The primary objective is to investigate the potential ability of Inderal (propranolol~     hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in~     cocaine dependent participants. If effective in this laboratory model, Inderal may have~     clinical efficacy.~   "
132627|NCT01319201|"~     Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different~     Glycaemic Status~      Aims:~      To evaluate coronary artery calcification and stenosis in community-dwelling adults with~     different glycaemic status, using dual-source CT angiography (CTA)~      Study Subjects and Methods:~      200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR)~     and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then~     underwent a comprehensive examination including questionnaire, anthropometric measurements,~     biochemical analysis and CTA.~      Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery~     Calcification and Stenosis~      Aims and Methods:~      To investigate the development of cardiovascular diseases in subjects recruited in part I~     and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up~      To identify the predictive value of coronary artery calcification and stenosis with future~     risks of cardiovascular diseases and the possible development of coronary artery disorders~     among participants with different glycaemic status~   "
132628|NCT01319188|"~     The investigators assume that ranibizumab might be dangerous in patients with history of~     coronary artery disease or cerebrovascular events. The main objective of study is to reveal~     contraindications for ranibizumab prescription in patients with history of coronary artery~     disease and cerebrovascular events. Moreover, an association between management with~     ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great~     interest as well.~   "
132629|NCT01319175|"~     Strength training of the hip flexors using elastic bands can induce an effect on isometric~     hip strength of at least 15 %.~   "
132630|NCT01319162|"~     Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese~     and obesity is closely linked to the development of PCOS. Although it is well established~     that obesity increases the severity of the clinical features of PCOS, data regarding the~     prevalence of PCOS in obese women and the change in body weight in women with PCOS over time~     are scares. In a prevalence study it was investigated whether obesity increases the risk of~     PCOS in the general population and they demonstrated that the prevalence rate of PCOS in~     underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%,~     respectively, similar to that observed in the general population. These results suggest that~     the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish~     prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence~     of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in~     Spain.~      First the investigators aim to estimate the prevalence/probability of PCOS among obese,~     premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal~     symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to~     standard weight reduction regime to the same extent as women without PCOS.~   "
132631|NCT01319149|"~     A retrospective molecular diagnostic review on wound care outcomes. The time periods include~     March, April, May of 2010.The retrospective review would analyze the days of healing during~     the timeframe, upon the introduction of molecular diagnostic testing~   "
133195|NCT01311609|"~     This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the~     physical effects of Systane Lubricant Eye Drops.~   "
132632|NCT01319136|"~     Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt~     surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize~     the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for~     shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients~     that had a preoperative investigation because of communicating hydrocephalus at the~     university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of~     this study was to evaluate a new method, with a new infusion protocol and new analysis~     methods, and compare it to the current method.~   "
132633|NCT01319123|"~     This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing~     against wound bioburden in moderately to highly exuding venous leg ulcers.~   "
132634|NCT01319110|"~     Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will~     perform a prospective trial with the primary endpoint of describing the prevalence of low~     serum CoQ10 levels.~      Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the~     administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of~     post-CA patients with the secondary endpoint of comparing CoQ10 levels among those~     randomized to CoQ10 supplementation vs placebo.~   "
132635|NCT01319097|"~     This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft~     tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.~   "
132636|NCT01319084|"~     Considering the development of gastric cancer surgery using da Vinci Robotic Surgical~     System, the development of educational program needs to be achieved in Korea and this~     institute. Moreover, because of the large number of gastrectomy including robotic surgery~     for gastric cancer treatment, the investigators can provide high quality of educational~     program using da Vinci System. Therefore, the investigators wanted to create an innovative~     real-time training module, which can provide an intraoperative step-by-step guide to robotic~     surgical procedures. This technological project was named as Advanced Robotic Multi-display~     Educational System (ARMES).~   "
132637|NCT01319071|"~     It is still unknown whether different genetic elements play a role in athletes' ability to~     create their area of specificity.In a study conducted in our laboratory few years ago, we~     genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender~     matched nonathletic controls. Few of these genes were found to be associated with athletic~     performance and area of specificity. Since then a few more genes have been found that are~     related to athletic performance, and our aim in the current study is to expand our research~     to these new genes which include 3 genetic cascades: genes associated with body fluid~     balance and homeostasis, genes associated with muscle strength, and genes associated with~     bioenergy.~   "
132638|NCT01319058|"~     Tonsil surgery for children suffering from obstructive sleep apnea have significant post~     operative morbidity including pain and occasionally bleeding. This morbidity is partly~     caused by post surgical inflammation. This inflammatory process can be quantified using~     various proinflammatory cytokines.~      the goal of this study is to objectively compare the inflammatory process after treatment of~     obstructive sleep apnea with different surgical approaches to the enlarged tonsils.~   "
132639|NCT01319045|"~     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in~     patients with congenital heart disease. Historically these patients suffered significant~     morbidity and mortality due to a lack of effective therapies. More recently, advanced~     therapies which target the mechanisms underlying the development and progression of PAH have~     been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies~     are all available for the treatment of PAH. Patients with PAH are first treated with oral~     agents (including sildenafil and bosentan). However, if these agents fail to achieve the~     desired effect for the patient, intravenous or inhaled therapies may be initiated.~     Combination therapy with multiple agents is common in routine clinical care. However, the~     most efficacious therapeutic regimen has yet to be delineated. The present study seeks to~     evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative,~     used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been~     approved by the FDA for use in this patient population. Adults with PAH already receiving~     oral therapy will be invited to participate in this study. Iloprost will be added to their~     current therapeutic regimen for a period of three months, with pre- and post-treatment~     assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six~     minute walking distance, and a quality of life questionnaire.~   "
132640|NCT01319032|"~     In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic~     groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of~     these genes were found to be associated with athletic performance and area of specificity.~     Since then a few more genes have been found that are related to athletic performance, and we~     intend to study various genes related to 3 genetic cascade: genes associated with body fluid~     balance and homeostasis, genes associated with muscle strength, and genes associated with~     bioenergy. The results of this study compared with athletic level will provide deeper~     insight into the genetic mechanisms involved in performance.~   "
132641|NCT01319019|"~     This study is primarily designed to assess the dose response, dose interval, efficacy and~     safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily~     (BID) doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days~     in subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in~     the study as an active comparator.~   "
132642|NCT01319006|"~     A randomized, open-label, 3-period crossover study.~   "
132643|NCT01318993|"~     An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice~     daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous~     GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157~     (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment~     change may be eligible to participate. The primary objective is to evaluate the safety of~     GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters,~     vital signs and electrocardiogram. Secondary objectives will include assessments of~     effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will~     include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and~     Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.~   "
132644|NCT01318980|"~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that~     attenuates the production of leukotrienes through the blockage of the first step in the~     leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of~     leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).~      This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an~     interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg~     milled tablet, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915~     intravenous solution.~      This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915~     to enable optimisation of suitable formulations to be used in clinical development Fourteen~     subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the~     subjects will receive an IV microtracer in addition to the other treatments.~   "
132645|NCT01318967|"~     Comparison of renal blood flow measurements by PAH clearance and MRI~   "
132646|NCT01318954|"~     This study will evaluate whether exhaled nitric oxide levels are affected by allergen~     immunotherapy (allergy shots). The investigators' hypothesis is that successful allergen~     immunotherapy may be accompanied by decreased exhaled nitric oxide levels.~   "
132647|NCT01318941|"~     This study will describe the long-term safety and effectiveness, treatment patterns,and~     patient reported quality of life associated with ranibizumab treatment in routine clinical~     practice for all approved indication included in the local product label.~   "
132648|NCT01318928|"~     The purpose of this study is to examine if the correct use of antibiotics, as well as the~     application of one-day-treatment, in the therapy of periodontal diseases. The population of~     treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical~     treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3:~     Metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment~     on day 1 and 21 End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all~     sites at 3 months, 1 -, 3 -, and 5 years post-treatment~   "
132649|NCT01318915|"~     The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given~     at the time of the transplant surgery, will help reduce or eliminate the need for long term~     immunosuppressive medication.~   "
132650|NCT01318902|"~     This study will include patients with previously treated systemic relapsed or refractory~     light-chain (AL) amyloidosis who require further therapy and will be aimed at determining~     the safety profile and the maximum tolerated dose/recommended phase 2 dose of IXAZOMIB~     administered orally.~   "
132651|NCT01318889|"~     Oral mucositis can be a significant problem for cancer patients. It is typically associated~     with pain and increased risk of infection and can lead to impaired nutritional status and~     inadequate hydration.it can be seen in the patient population receiving high-dose head and~     neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving~     stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness~     and elasticity. The stimulation of epithelization, granulation and mitigation of itching~     were the most prominent effects of formulations containing dexpanthenol. The investigators~     suppose that dexpanthenol mouth wash may improve oral mucositis.~   "
132652|NCT01318876|"~     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or~     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines~     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976)~     and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the~     pH1N1, an increase of allergic-like reactions was observed.~      Passive surveillance is collecting notifications of adverse events (AE) on the whole~     population but the sensitivity of this system is not high and its timeliness is not~     necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators~     piloted a web-based active surveillance of a large number of health care workers (HCW)~     vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK,~     Canada). Because healthcare workers (HCW) constituted a well-defined group with general good~     health and received the Influenza vaccine in priority, this group of people was well suited~     for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited~     in three different sites (5183 were from Quebec). A total of 468 events (local reactions,~     fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430~     HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded~     to all questionnaires. During this surveillance, the investigators didn't have unexpected~     findings but this active surveillance of adverse events among healthcare workers would have~     been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200~     vaccinees. For this year the investigators want to expand the surveillance to more sites and~     more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to~     increase the response rate to all three surveys in participants.~      The main objective of this project is to estimate in HCW vaccinated against influenza the~     frequency of adverse events of sufficient severity to cause work absenteeism or medical~     consultation.~      This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto,~     Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to~     detect AE occurring at a rate of ≥ 1 per 500 vaccinees.~   "
132653|NCT01318863|"~     More than one site will participate in the collection of blood and urine samples from~     healthy adult subjects. These samples will be used for future testing to serve as~     aged-matched normal controls and to establish normal reference ranges in the development of~     new invitro diagnostic devices.~   "
132654|NCT01318850|"~     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with~     schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying~     cognitive improvement is not well understood. The aim of this study is to investigate~     functional connectivity patterns before and after the neurocognitive rehabilitation therapy,~     especially in fronto-temporal circuitry.~   "
132655|NCT01318837|"~     This study is to evaluate change of over active bladder symptom scores (OABSS) between,~     before and after solifenacin treatment to OAB subjects.~   "
132656|NCT01318824|"~     To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory~     failure.~   "
132657|NCT01318811|"~     Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous~     renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been~     validated. Our study will compare dilute heparin to a standard concentration of heparin. The~     investigators hypothesize that heparin delivered in a dilute solution will augment coating~     of the filter fibers with anticoagulants, decreasing clotting events and increasing filter~     life. By improving delivery of heparin to the filter and circuit, where clotting events can~     disrupt dialysis, less heparin would be required for the extra-corporeal circuit and thus~     less heparin would be delivered back to the patient with blood return from the machine. By~     exposing the patient to less heparin it is hypothesized that fewer bleeding events would~     occur, making the dialysis treatment safer. If more of the filter's fibers remain patent and~     the filter is functional for a longer period of time, the CRRT would also be more effective.~   "
132660|NCT01318772|"~     The purpose of this study is to acquire the clinical data required by the United States Food~     and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution~     imaging system for fluoroscopy/radiography. It is expected that the new KALARE~     (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of~     30 cases will be submitted for evaluation of claims for intended clinical applications.~   "
132661|NCT01318759|"~     This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people~     in order to be able to assess their multiple organ pathology, cognitive, functional and~     social problems. This CGA is a very time consuming tool although a powerful one.~      The investigators want to present a new assessment test witch is short and comprehensive~     tool witch will be checked in ambulatory and in-hospital geriatric patients.~   "
132662|NCT01318746|"~     The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In~     patients with renal failure, the potassium value is not stable and tends to raise. Until now~     there are no data available if the potassium value has a circadian rhythm and if there are~     individual changes from day to day.~   "
132663|NCT01318733|"~     A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5%~     once daily in subjects with moderate to severe facial erythema associated with rosacea.~   "
132664|NCT01318720|"~     Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on~     techniques for the treatment of neck pain is an intervention commonly implemented in~     clinical practice. Recently researchers and clinicians have implemented manual therapy~     techniques to the thoracic spine (midback) to treat patients with neck pain. To date no~     studies have examined the short-term combined effects of thoracic spine manual therapy and~     cervical spine manual therapy in the treatment of patients with mechanical neck pain. The~     purpose this study is to assess the combined effects of thoracic spine thrust manipulation~     with cervical spine non-thrust manipulation in patients with neck pain.~   "
132665|NCT01318707|"~     The purpose of this study is to compare the standard collection of whole blood in tiger top~     tubes for serum collection versus a collection method of added FVIII to whole blood samples~     in the hemophilia population for routine biomarker assays to ensure reliable assay results.~   "
132666|NCT01318694|"~     This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy~     [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment~     in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)~   "
132667|NCT01318681|"~     This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory~     functions. Our group has previously shown that patients suffering from AR symptoms perform~     less well on tasks requiring sustained attention compared to non symptomatic controls. Car~     driving is a typical behavior that is susceptible for changes in sustained attention and~     might therefore become worse under conditions when patients suffer from AR symptoms. We will~     compare the driving performance of untreated, symptomatic AR patients with the performance~     of symptomatic patients that have been treated with either a systemic AR medication (a pill)~     or a topical medication (nasal spray)~   "
132668|NCT01318668|"~     In this study the effects of a nicotine challenge on brain activity, behavior and mood will~     be evaluated in two groups of healthy volunteers who have a smoking habbit: The first group~     will undergo a series of treatments with NicVax, aimed at producing nicotine antibodies in~     the body and preventing nicotine to enter the brain. The second group will receive a placebo~     treatment. This pre-treatment (vaccination) will take place over a 18-week period. All~     participants will then undergo two days of testing. On each day the subjects will perform a~     number of psychomotor and memory tests after a challenge with nicotine (gum) or~     placebo(gum). Also brain activity will be studied in an fMRI scanner. We expect to see an~     effect on brain activation and performance only in the placebo-vaccinated group. The Nicvax~     vaccinated group should show activation and performance comparable to that after challenge~     with placebo(gum) as in this group nicotine should not cross the blood brain barrier and~     enter the brain~   "
132669|NCT01318655|"~     The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with~     healthy subjects.~   "
132670|NCT01318642|"~     This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled~     trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for~     locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will~     be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo.~     Randomization will be stratified by ECOG (0 or 1).~      Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of~     every 28 day cycle. Treatment will continue until radiographic disease progression,~     unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.~   "
132671|NCT01318629|"~     Many patients undergoing coronary angiography are found to have no significant coronary~     artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic~     abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically~     assess patients with angina equivalent symptoms despite normal coronary angiograms and to~     evaluate their symptoms according to a defined algorithm.~   "
132672|NCT01318616|"~     The purpose of this study is to investigate the effect of strength training with elastic~     bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The~     primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that~     strength training with elastic bands will result in a clinical relevant increase in hip~     adduction strength.~   "
132673|NCT01318590|"~     The purpose of this study is to determine if celiac bloc (with injection of steroid and~     local anesthetic) is superior to a sham procedure for pain control and quality of life~     improvement in patient with chronic pancreatitis and abdominal pain.~   "
132674|NCT01318564|"~     The goal of this clinical research study is to test an investigational type of packaging for~     diabetes drugs called unit-dose packaging. Researchers want to learn if unit-dose~     packaging can help patients with Type II diabetes to take their drugs on the proper~     schedule.~   "
132675|NCT01318551|"~     Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single~     dose group stratified study in renal impaired and healthy subjects.~   "
133244|NCT01310946|"~     Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology~   "
132676|NCT01318538|"~     The purpose of this study is to conduct a randomized controlled Stage II trial of the~     Women's Recovery Group (WRG) in a larger, more diverse sample of women than characterized~     that of the investigators' Stage I trial. The current study is being conducted at two sites.~     The investigators will compare 12 weekly sessions in an open-enrollment format of the~     women-focused, single-gender WRG versus an equivalent amount of the active comparison~     treatment, mixed-gender Group Drug Counseling (GDC). In addition to testing the efficacy of~     the WRG, the investigators' second aim will be to investigate a priori hypotheses regarding~     potential moderators (e.g., psychiatric severity, self-efficacy) and mediators (e.g.,~     engagement in ancillary treatment and community support) of treatment outcome. Finally, the~     investigators will conduct exploratory analyses of group process characteristics of the WRG~     identified during the Stage I trial and explore differences in group process between~     single-gender WRG and mixed-gender GDC groups.~   "
132677|NCT01318525|"~     Acute liver failure is a rare but dramatic disease, often affecting young people, marked by~     the sudden loss of liver function in a person without preexisting liver disease.~      ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and~     liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this~     dramatic disease with high unmet medical need, a future therapy for the treatment of~     patients suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due~     to acetaminophen overdose, where liver transplantation is the sole treatment in the absence~     of spontaneous recovery.~      The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.~      A minimum of 60 patients will be recruited into the study in the following two treatment~     groups:~        -  Group A: approximately 30 patients will receive ALF-5755~        -  Group B: approximately 30 patients will receive placebo (physiological saline solution:~          0.9% NaCl)~      Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow~     intravenous infusions over 10 minutes using automatic syringes.~   "
132678|NCT01318512|"~     This observational, prospective, multicenter study will describe the mean dose of Mircera~     (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with~     chronic kidney disease. Patients are not on dialysis and are naive to, or have received~     erythropoiesis stimulating agent treatment. Data will be collected for 10 months.~   "
132679|NCT01318499|"~     The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic~     Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and~     pain in the eye after cataract extraction.~   "
132680|NCT01318486|"~     The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the~     heparin free treatment can be performed easily (without saline flushes or blood predilution)~     and is at least not inferior and maybe superior to the standard care heparin free treatment~     in terms of clotting.~   "
132681|NCT01318473|"~     This will be a prospective, single-arm, single-center, open-label study to evaluate the use~     of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm~     undergoing CT-guided percutaneous chest aspiration.~      Target location will be in the chest area; the procedure will be performed by a trained~     physician.~   "
132682|NCT01318460|"~     The present pilot study aims to investigate the effectiveness of the preoperative infusion~     of levosimendan in patients with impaired left ventricular function undergoing coronary~     artery bypass grafting.~   "
132683|NCT01318447|"~     This prospective, multicenter study is intended to establish the efficacy and toxicity of~     treating unresectable colorectal liver metastases with accurately administered radiation~     using the CyberKnife stereotactic radiosurgery system.~   "
132684|NCT01318434|"~     The main research hypothesis for this study is that, among patients with Major Depressive~     Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree~     of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression~     Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at~     the dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the~     sequential parallel comparison design. The secondary research hypothesis for this study is~     that, among patients with MDD who have responded inadequately to treatment with SSRIs or~     SNRIs, the degree of improvement in depressive symptoms, as assessed by the MGH Cognitive~     and Physical Functioning Questionnaire (MGH CPFQ) will be significantly greater among those~     treated with EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.~   "
132685|NCT01318421|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in~     patients with multiple sclerosis (MS) after participation in study MS103.~   "
132686|NCT01318408|"~     Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants~     are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in~     elderly dementia patients with seizures. While it has been established that Keppra controls~     seizures in this age group, it is important to demonstrate that treatment with Keppra would~     not affect cognitive abilities in this large population of patients . As this population is~     already cognitively impaired, the best choice of anticonvulsant would be one that does not~     further compromise their cognitive abilities. Keppra is an excellent anticonvulsant agent in~     the elderly for a variety of reasons, including safety, favorable side effect profile, lack~     of interaction with other drugs, and efficacy. Our retrospective pilot data suggests that~     cognition is not negatively affected by Keppra. The current prospective study will assess~     the cognitive abilities of persons with cognitive impairment at baseline and at weeks 4 and~     12. The overall objective is to determine the cognitive tolerability of Keppra for seizures~     in elderly cognitively impaired patients.~   "
132724|NCT01317914|"~     Direct benefits to the participants, who are diagnosed with celiac disease may be~     substantial and could include lessening or prevention of GI symptoms, correction of~     biochemical abnormalities and reduction in risk for malignancies or bone disease which are~     most common in untreated celiac disease. However, the precise benefit is unknown and the~     motivation for this proposed study. If these individuals have a positive celiac serology~     test at the present time there is a high likelihood that they may have celiac disease.~   "
133245|NCT01310933|"~     The purpose of this study is to differentiate Kikuchi's disease and malignant lymphoma by~     soft tissue ultrasound.~   "
132687|NCT01318395|"~     Hypertension affects approximately one fourth of the world population and therefore~     contributes substantially to the worldwide burden of cardiovascular (CV) disease and~     end-organ damage.~      Changes in small artery structure characterized by an increased wall-to-lumen ratio (WLR)~     are characteristic feature of target organ damage in hypertension. Of clinical importance,~     structural arteries of small subcutaneous arteries have been shown to be of prognostic~     significance, with adverse prognosis in subjects with higher WLR. However, the assessment of~     arteriolar structure from biopsies of subcutaneous tissue is invasive and impractical in~     clinical practice. A new approach focuses on retinal arteriolar structural parameters by~     using scanning laser Doppler flowmetry (SLDF) with automatic full-field perfusion imaging~     analyses (9). This approach allows the non-invasive assessment of both the outer diameter~     (OD) and inner diameter (ID) of retinal arterioles in vivo and, thus, analyses vascular~     remodeling of retinal arterioles by calculating WLR = (OD - ID) / ID).~      A crucial role in the efforts of prevention of end-organ damage plays the renin angiotensin~     system (RAS). The increased mechanical strain on the vasculature at a higher BP can cause~     injury to the endothelial wall. Activation of the RAS increases BP and stimulates a local~     inflammatory response to repair the injury. Long-term or repeated response to injury leads~     to endothelial dysfunction and microvascular damage, and hence end-organ damage.~      Combining RAS inhibitors may provide greater end-organ protection than use of either class~     alone. However, ONTARGET has failed to show superiority of the dual RAS blockade (ACE-I and~     ARB) in patients at high cardiovascular risk. The combination of ARBs and direct renin~     inhibitors (DRIs) emerged as the only available, valid and innovative option for blocking~     the RAS at two different sites (sequential blockade). Indeed, AVOID study and ALLAY study~     demonstrated that the DRI aliskiren has additional and to some extent blood pressure~     independent effects on albuminuria and left ventricular hypertrophy, both signs of~     subclinical organ damage in hypertension, respectively.~      However, no data are available with respect to the effects of ARBs and DRIs on vascular~     properties in the short and long term To close this gab we focus in this study on vascular~     structural and functional changes since vascular adaptation to high blood pressure occurs in~     the early phase of hypertensive disease.~   "
132688|NCT01318382|"~     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios~     at tracheal extubation when anesthesiologists have determined that full recovery of~     neuromuscular function has occurred using standard clinical criteria for participants whose~     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase~     inhibitor administered as per standard routine care.~   "
132689|NCT01318369|"~     The main goal of this trial is to study the efficacy of Namisol® after a single dose of~     Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of~     pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are~     included to provide insight in underlying nociceptive processing.~   "
132690|NCT01318356|"~     The objective of this study is to assess the efficacy of two treatment strategies for~     fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive~     behavioral therapy (CBT).~   "
132691|NCT01318343|"~     The purpose of this study is to evaluate the safety and efficacy of single treatment vs.~     multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of~     subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.~   "
132692|NCT01318330|"~     Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of~     Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease~     Patients~      Sponsor: HomeoTherapy Co.,Ltd~      Study Design: Single Group, Open Label, 5 Week, Safety Study~      This study is designed to evaluate the safety of ex-vivo cultured adult human clonal~     mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute~     or chronic graft-versus-host disease (GVHD).~      Study Type: Interventional~   "
132693|NCT01318317|"~     This phase I/II trial studies the side effects and best dose of genetically engineered~     lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant~     (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma~     (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in~     different ways and stop cancer cells from growing. Giving rituximab together with~     chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing~     or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or~     plerixafor helps stem cells move from the bone marrow to the blood so they can be collected~     and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for~     the stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered~     lymphocyte therapy after PBSCT may be an effective treatment for NHL~   "
132694|NCT01318304|"~     The innate immunity of the vaginal tract provides first-line defense from abnormal~     microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella~     vaginalis. It is unclear from the current available literature whether the rate of vaginal~     infection increases or decreases in frequency during pregnancy when compared to the~     non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal~     infections are important players in HIV disease, potentially increasing the risk of viral~     transmission. In addition, these infections may activate inflammatory markers in the~     reproductive tract and increase the risk of premature delivery or other negative pregnancy~     outcomes. The vaginal innate immune system has not been well characterized in pregnant~     women, or in women with HIV infection. The study of how this system changes in pregnancy and~     HIV infection will provide essential knowledge for further study of vaginal mucosal~     protection.~      The investigators study is an observational study designed to compare levels of vaginal~     innate immunity markers in women based on a) pregnancy status and b) HIV infection status.~     Comparisons will be made between pregnant and non- pregnant women and between HIV positive~     and HIV negative women. The investigators hypothesize that there will be significant~     differences in levels of innate immunity between the groups.~   "
132695|NCT01318291|"~     The most common reason why insured In Vitro Fertilization (IVF) patients drop out of~     treatment is the distress caused by the treatment.~      The objective of this study is to determine the efficacy of a combined Cognitive Coping and~     Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.~   "
132725|NCT01317901|"~     This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in~     subjects with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study~     to determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab~     and bendamustine and to determine a safe dosing regimen for the combination in up to 12~     subjects with relapsed indolent lymphoma.~      The originally planned Phase 2 portion, an open-label, randomized study to evaluate the~     efficacy of BRT compared with BR, was not conducted.~   "
133262|NCT01310712|"~     Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and~     axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of~     Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.~   "
132696|NCT01318278|"~     Low blood pressure or hypotension is a very important problem that is often seen in~     premature babies, especially those with low birth weight. Severe hypotension leads to~     significant problems including brain bleeds, developmental delays, kidney and liver~     problems, and other issues that can affect babies for the rest of their lives. An important~     aspect in the management of infants with hypotension is the decision of when to treat and~     with what agent. Research is being conducted to try to find the best medication to use in~     these situations. Dopamine is often used first, but it does not always prove to be~     effective, and it has several concerning side effects. This study will look at vasopressin,~     which has fewer side effects, as a first-line medication for low blood pressure in extremely~     low birth weight infants.~      Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in~     preterm, extremely low birth weight infants who have hypotension within the first 24 hours~     of life. We will specifically look at its ability to raise blood pressure values, improve~     clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.~   "
132697|NCT01318265|"~     The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the~     pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.~   "
132698|NCT01318252|"~     The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared~     with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular~     hypertension.~   "
132699|NCT01318239|"~     The purpose of our study is to establish the accuracy of the perfusion MRI parameters and~     the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in~     predicting the response of liver metastasis from colorectal cancer to treatment with~     antiangiogenic agent.~   "
132700|NCT01318226|"~     This is a Phase 2 randomized, double-blind, placebo-controlled, multiple-dose, multicenter,~     parallel-group study to evaluate the analgesic activity of ATx08-001, a novel selective~     peroxisome proliferator-activated receptor modulator (SPPARM), in subjects with~     moderate-to-severe postherpetic neuralgia pain. Eligible subjects will be randomized to~     receive either placebo or Atx08-001. Study drug will be administered orally twice a day for~     7 days. Subjects will be evaluated for neuropathic pain intensity at regular intervals over~     a 6 hour period on Day 1 following the first dose of study drug. They will then be~     discharged from the clinic and will complete diary assessments of pain severity twice a day~     at home. Subjects will be asked to return to the clinic on Day 8 to complete their last set~     of pain evaluations.~   "
132701|NCT01318213|"~     This study will test if doctors, nurses and other people who take care of patients in~     hospitals wearing gloves and gown for all contact with patients in an intensive care unit~     (ICU) will:~        -  Decrease the chance of patients getting an infection while in the hospital~        -  Decrease the chance of patients picking up bacteria as a result of being in the~          hospital~        -  Decrease the time a patient spends in the ICU or in the hospital~        -  Increase the frequency of adverse events~      The study will also look at whether making doctors, nurses and other people who take care of~     patients wear gloves and gown for all contact with patients will decrease the amount of time~     healthcare workers spend with patients.~      This study will gather information by comparing what happens in ICUs that continue to do~     what they were doing before the study with what happens in ICUs that require healthcare~     workers to wear gloves and gown for all contact with patients.~      This study will provide information that will help to make being in the hospital safer for~     all patients.~   "
132702|NCT01318200|"~     To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic~     body radiotherapy in the treatment of patients with locally recurrent hepatocellular~     carcinoma (HCC) after TACE.~   "
132703|NCT01318187|"~     STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and~     safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank~     pain.~      METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial~     comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for~     patients presenting to the emergency department (ED) with acute flank pain. Subjects with~     inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).~   "
132704|NCT01318174|"~     The purpose of this study is to determine the prevalence of pulmonary embolism in our~     population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital~     with dyspnea. The patients will undergo investigation for pulmonary embolism, according to~     current guidelines.~   "
132705|NCT01318161|"~     Colorectal cancer is one of the most common cancers in the industrialized world (12% of all~     cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost~     half of these cases result in death. Several recently published retrospective studies show~     that regional anaesthesia (RA) can reduce cancer-related mortality following surgical~     treatment of colorectal, breast and prostate cancers and malignant melanoma. If these~     results are true, then the choice of perioperative pain management is as beneficial, or even~     better, than the current oncological therapies. This theory needs to be investigated in a~     prospective, randomized and controlled trail.~   "
132706|NCT01318148|"~     The study is a pilot phase II, prospective, non-comparative, single center trial aimed to~     evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal~     prophylaxis in high risk patients.~   "
132707|NCT01318135|"~     To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea~     (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).~   "
132708|NCT01318122|"~     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin~     and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who~     completed a phase 2/3 Thiazolidine add on study.~   "
132709|NCT01318109|"~     The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy~     (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2~     diabetic patients with uncontrolled blood glucose.~   "
132710|NCT01318096|"~     In this pilot study, the investigators would examine the safety and efficacy of integrase~     inhibitor-Raltegravir in the control of HIV/HBV co-infection.~   "
132711|NCT01318083|"~     The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily~     (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients~     with uncontrolled blood glucose.~   "
132713|NCT01318057|"~     Warfarin (Coumadin) is a prescribed blood thinner medication used to make the blood less~     thick in people with high risk of forming blood clots. Despite the various methods to~     monitor this drug, life-threatening bleeding is a common undesired effect and might result~     in patient death. Patients starting warfarin therapy may require several weeks or even~     months to reach the appropriate blood level of warfarin. This blind practice could place the~     patient at high risk. There are several demographic and clinical factors that significantly~     influence how much warfarin the patient needs to attain the desired response. Genes, which~     control hereditary traits, are also important. Now, the investigators know that by using the~     information encoded in patient's genes the investigators are able to individualize the~     therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1).~     This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in~     warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array~     comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the~     investigators are able to determine the structure of the Puerto Rican population in terms of~     ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1~     variants. Secondly, the investigators will assess the association of these variants to~     clinical responses in order to develop a better method of dose estimation. The expected~     result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill~     a gap in the knowledge of warfarin pharmacogenetics, providing new information on the~     prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as~     well as their role in the warfarin response variability observed in this admixed population.~   "
132714|NCT01318044|"~     Magnetic resonance imagining (MRI) in children requires sedation to achieve the degree of~     cooperation or immobilization, necessary to complete these procedures successfully. In this~     study the investigators analyze two most popular anesthetics used for this procedure, sodium~     thiopental and propofol. The aim of this study is to determine optimal dose of propofol and~     thiopental during MRI and to establish safety and efficacy of these drugs.~   "
132715|NCT01318031|"~     Study of a drug drug interaction between Paroxetine and PF-00299804.~   "
132716|NCT01318018|"~     Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients~     suffering from depression, who do not respond to medical treatment. However it is often~     dismissed by patients, who feel uncomfortably about the application of electric shocks to~     their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses~     magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT~     in terms of its antidepressant potency but may be associated with less severe cognitive side~     effects.~      Control of anaesthesia during seizure therapy is demanding since light anesthesia might be~     associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the~     convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor~     anaesthesia for ECT, however little is known about BIS following MST.~      The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster~     increase in BIS and that (b)less left-right differences occur in BIS.~   "
132717|NCT01318005|"~     The purpose of this research study is to gain a better understanding of the changes that may~     occur in the breast when a woman uses an oral contraceptive (birth control pill). Some~     research indicates that women who use birth control pills with lower amounts of estrogen (a~     hormone in the birth control pill) may have lower breast cell growth than women who use~     birth control pills with a higher amount of estrogen; this research will examine that in~     detail. This research will also test whether the results found in HS-07-00269 can be~     confirmed.~   "
132718|NCT01317992|"~     The purpose of this study is to determine if ibudilast is effective in reverting patients~     with medication overuse headache suffering chronic daily headache back to their original~     episodic headache pattern.~   "
132719|NCT01317979|"~     Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically~     worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM~     is of limited success. Because not well controlled T2DM patients are in high risk of~     blindness, cardiovascular accident and end staged disease, T2DM has become a major health~     burden for society. Recent data on the relative effectiveness of gastrointestinal metabolic~     surgery played as bariatric surgery in the remission of T2DM, suggests that it may be~     significantly more effective than current medical treatment. In considering that less than~     half of the T2DM patients can achieve satisfactory treatment goal under current medical~     treatment, gastrointestinal metabolic surgery shall play an important role in T2DM treatment~     in the future. However, the indication for metabolic surgery and clinical predictors of~     success are not clear now. These clinical predictors can help us to choose appropriate~     not-well controlled T2DM patients to receive metabolic surgery and reduce dverse health~     outcomes in those patients.~   "
132720|NCT01317966|"~     The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11)~     Combination Low-dose Rituximab prednisone are effective and safe in the management of~     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).~   "
132721|NCT01317953|"~     The purpose of this study is to determine whether green tea extract is safe for~     extensive-stage small lung cancer who achieved objective tumor response after first-line~     therapy.~   "
132722|NCT01317940|"~     Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone~     density by the end of treatment. This can lead to long-term suffering in survivors due to~     poor bone health. Vitamin D is known to be associated with bone health and previous research~     has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens~     over the course of treatment. Researchers have also learned that a relationship exists~     between both Vitamin D and fat tissue and ALL and fat tissue.~      In adolescents being treated for ALL as well as in early survivors, this randomized study~     will therefore examine the effect of Vitamin D and calcium supplementation on correcting~     Vitamin D insufficiency and on improving bone density in the context of changes in body~     composition and body fat. Bone density will be measured by a radiology exam called a~     quantitative computed tomography (or qCT) while body composition and body fat will be~     measured by a different radiology exam called a dual energy x-ray absorptiometry (or DEXA~     scan). The study will also examine in depth the relationship between these three elements -~     Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.~   "
132723|NCT01317927|"~     The purpose of this study is to evaluate the plasma concentration and pharmacodynamics~     effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².~      Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of~     warfarin 5 mg.~   "
132726|NCT01317888|"~     The purpose of this access protocol is to allow patients with brain tumors who had~     previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their~     brain tumor begins to grow, they develop side effects to the treatment, or their medical~     condition changes (e.g., you become pregnant, become infected with human immunodeficiency~     virus (HIV) or develop another cancer).~   "
132727|NCT01317875|"~     This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib~     in patients with myelofibrosis (MF). The study consists of two periods: the core study~     period, comprising the dose escalation stage and the safety extension phase up to Week 24,~     then the extension study period beyond Week 24 and up to 3 years, to further characterize~     the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase~     will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until~     the maximum safe starting dose (MSSD) is determined. In the safety expansion phase,~     additional patients will be treated with ruxolitinib at the MSSD defined during dose~     escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with~     MF and starting platelet counts < 100 x 10 ^9/L~   "
132728|NCT01317862|"~     The purpose of this study is to assess the effectiveness and safety of transcervical foley~     catheter as compared to prostaglandins for preinduction cervical ripening and labor~     induction in term nulliparous women with unfavorable cervix.~   "
132729|NCT01317849|"~     The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary~     stroke prevention trial in China to determine whether the addition of folic acid and vitamin~     supplements will reduce recurrent stroke events and other combined incidence of recurrent~     vascular events and vascular death.~   "
132730|NCT01317836|"~     Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical~     practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly~     restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector~     computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional~     modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic~     accuracy still remains compromised. Furthermore, recently encouraging results have been~     obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission~     tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to~     enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients~     with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.~   "
132731|NCT01317823|"~     To compare the ultrasonographic cervical length with the Bishop score in determining the~     administration of prostaglandin for preinduction cervical ripening in multiparous women at~     term.~   "
132732|NCT01317810|"~     The purpose of this study is to track changes in overactive bladder (OAB) medical regimen~     and/or OAB medication dosage requirements.~   "
132733|NCT01317797|"~     The purpose of this trial is primarily to investigate the safety and tolerability of~     repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid~     arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be~     investigated how the body responds to MT203 treatment and if MT203 is effective in the~     treatment of rheumatoid arthritis.~   "
132734|NCT01317784|"~     The relevance of this research to public health is to make it possible to test for hepatitis~     C and syphilis at point of care so that people will receive their results immediately~     instead of requiring people to wait for at least a week to get their test results. This~     research will make rapid tests for HIV available that can detect HIV infection earlier and~     are more accurate than current tests available in the United States.~   "
132735|NCT01317771|"~     Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis~     with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to~     participate in the study. The study will assess the tendon healing to bone through magnetic~     resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS)~     pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for~     our objective will include age, hand dominance, gender and chronicity of symptoms prior to~     surgery, and other related surgical procedures.~   "
132736|NCT01317758|"~     Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years~     old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized,~     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study~     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted~     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular~     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg~     given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will~     receive 2 doses separated by approximately 21 days.~   "
132737|NCT01317745|"~     Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years~     old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized,~     double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study~     and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted~     vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular~     subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg~     given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will~     receive 2 doses separated by approximately 21 days.~   "
132738|NCT01317732|"~     In this study we propose 1) to develop a new multisensor monitoring system associating a~     tri-axial accelerometer and a magnetometer to measure physical activity in free-living~     adults, 2) to perform its calibration and assess its validity in a series of activity tasks~     in comparison with the measure of energy expenditure by indirect calorimetry as the~     criterion measure, and with existing physical activity monitors (cardiofrequencemetry and~     accelerometers used either alone or in combination). Briefly the subjects will perform a~     series of standardized activity tasks of different intensities and a 30-min free physical~     activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors.~     Physical activity energy expenditure will be measured using a metabolic gas analyser.~      Data of the 30 first subjects will be used to develop new algorithms to identify the~     different activity tasks and to estimate the related energy expenditures. Data of the~     following 30 subjects will be used to validate the MotionPOD(TM) against indirect~     calorimetry and existing physical activity monitors~   "
132739|NCT01317719|"~     The primary goal of this study is to determine if surgical repair of the distal biceps fully~     restores the supination strength of the forearm. Secondarily, the investigators want to~     examine the insertion site location of the tendon and determine if it correlates with the~     patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand~     (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.~   "
132741|NCT01317693|"~     Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile~     tissue. Shockwaves are created by a special generator and are focused using a specially~     designed shockwave applicator apparatus. The shockwaves are delivered through the applicator~     covering the corpora cavernosa of the penis. In previous studies the investigators used a~     medium focused probe and in this study the investigators are evaluating results of this~     therapy using a wider focus probe in the aim of improving results of treatment.~   "
132742|NCT01317680|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth~     of new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply~     (damage that can occur after radical prostatectomy in addition to neural damage or solely)~     that do not respond to oral therapy (PDE-5 inhibitors).~   "
132743|NCT01317667|"~     This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the~     safety and immunogenicity of the RVEc vaccine.~      The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable~     safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA~     immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody~     (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine~     recipients.~   "
132744|NCT01317654|"~     All patients who were alive at the end of the dexamethasone treatment trial conducted by~     Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to~     participate in this long-term follow-up study.~      All eligible and consenting patients will undergo an assesment consisting of a simple~     questionnaire, a clinical examination and a blood test. Data collected will focus on~     survival, neurological disability and tuberculosis relapse. Data will be collected in~     individual case record forms and entered into a computer database.~   "
132745|NCT01317641|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of~     ODM-201 in patients with castrate resistant prostate cancer.~   "
132746|NCT01317628|"~     Researchers have noted that active smoke exposure was possibly related to epigenetic~     mechanism,and may further influence reactive immunotoxicological reaction on human beings.~     Some studies have been reported that smoking reduction would decrease the prevalence of~     respiratory symptoms and urinary cotinine level, but the underlying epigenetic mechanism and~     the functional changes of immunotoxicological system were still unclear. We plan to examine~     the causal relationship between smoking reduction and alterations in epigenetic~     signatures/immunotoxicological reactions. Teenager Smoking Reduction Trial (TSRT) will be~     population-based trial among teenagers. Eligible teenagers will be recruited in Taipei City~     and urinary cotinine level will be used to monitor the exposure status of active smoking at~     baseline, 1-month and 3-month of the intervention process. We will assess the potential~     change in immunotoxicological markers, including Th1/Th2 cytokines and clinical~     immunological measurements, before and after the intervention program. Furthermore,~     whole-genome methylation and miRNA expression microarrays will be used to search candidate~     genes for teenager smoking exposure. We plan to develop a prediction model for~     immunotoxicological reaction by utilizing epigenetic signature data from microRNA expression~     and DNA methylation profiles based on machine learning methodologies. We will also establish~     a personalized epigenetic prediction model for allergy development and build the risk~     assessment platform for immunotoxicological reaction under tobacco smoke exposure. Finally,~     we will examine the causal relationship between epigenetic signatures and~     immunotoxicological reactions under an independent children's cohort.~   "
132747|NCT01317615|"~     This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in~     patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine~     differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.~   "
132748|NCT01317602|"~     This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF)~     in Greece, designed to provide real world data regarding the characteristics of AF patients~     in Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.~   "
132749|NCT01317589|"~     Background of the study:~      Treatment of Pain in Head-and-Neck Cancer Patients:~      is methadone more effective than fentanyl?~      Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one~     third of the patients. In patients with head-and-neck cancer neuropathic pain is far more~     prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is~     complex and available treatment modalities achieve (partial) pain relief in only 40-60% of~     patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of~     neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in~     patients with cancer.~      Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor~     antagonist qualities have been described. Many small studies and case-reports describe the~     successful rotation from different strong opioids to methadone. There are no studies that~     selected patients with (predominantly) neuropathic pain to be treated with methadone,~     whereas this group of patients is expected to profit from the NMDAR-antagonist properties of~     methadone.~      Objective of the study:~      This randomised controlled trial (RCT) aims to investigate whether addition of a~     NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of~     predominantly neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief~     and time to achieve significant pain relief.~      Study design:~      Open label randomised controlled trial~      Study population:~      opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic~     pain with a NRS score of ≥ 4, age =/> 18 years~      Intervention Treatment with methadone or fentanyl patch~      Primary study parameters/outcome of the study:~      Is methadone more effective than fentanyl in the treatment of pain in patients with~     head-and-neck cancer with respect to~        1. significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and~        2. pain interference~      Secondary study parameters/outcome of the study:~      Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck~     cancer with respect to~        1. time to achieve significant pain relief~        2. side-effect profile?~   "
132770|NCT01317316|"~     Patients with work-related eye injuries (WREI) admitted to the center in the four-year~     period were enrolled in this prospective study. Institutional Review Board approval was~     obtained before commencement of the study. A special data recording system was developed for~     the study. The study sample comprised only the casualties occurred at workplace and while~     working de facto. The data were abstracted via face to face contact in the emergency~     department (ED). The data sheets comprised sociodemographic and injury-related information~     brought together in 15-item questionnaire. Causes of occupational injuries as reported by~     the victims were assigned to either of two groups: Worker-related causes and~     workplace-related causes.~      Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated~     room in the ED was used for this purpose in order to prevent bias and the patients were not~     accompanied by any person other than the medical personnel in charge of due medical care.~     The patients were also assured that the information obtained by the survey are to be used~     for research purposes only and no feedback is to be given to employers or related persons.~      Patients who did not give consent for the study, fatal accidents and patients younger than~     15 years of age were excluded from the analysis.~   "
132750|NCT01317576|"~     Due to the western lifestyle, correlated with a high calorie intake and low physical~     activity, obesity is becoming a major health problem. All over the world obesity reaches~     epidemic proportions. Obesity is closely linked to type 2 diabetes, a multi-factorial~     disease that increases the presence of multiple health problems. Until now, exercise and~     dietary intervention seem to be the single most effective interventions to treat obesity and~     type 2 diabetes mellitus. In obesity and type 2 diabetes, not only fat accumulation in~     adipose tissue, but also fat accumulation in the peripheral tissues occurs. Fat accumulation~     in peripheral tissues has been associated with insulin resistance. Exercise seems to have a~     positive effect on the accumulation of fat in the peripheral tissue and on the insulin~     sensitivity in type 2 diabetic patients.~      In this study we want to investigate if a prolonged exercise training program can lower the~     intrahepatic lipid content and can improve the metabolism of the liver in type 2 diabetic~     patients and patients with non-alcoholic fatty liver disease, and to examine if this leads~     to improvements in metabolic risk markers. To this end, we will include investigation of the~     effect of exercise on adipose tissue (inflammatory markers and adipocyte size) and skeletal~     muscle (ex vivo lipid metabolism) to incorporate the effect of exercise on liver, muscle and~     adipose tissue and to clarify the crosstalk between these tissues in the pathophysiology of~     type 2 diabetes.~   "
132751|NCT01317563|"~     This project will assess the effectiveness of antioxidant supplementation with common~     vitamins A, C, E and selenium in controlling asthma symptoms among lean and obese~     asthmatics. This project may improve our ability to treat asthma and our understanding of~     the link between nutritional antioxidants and asthma.~   "
132752|NCT01317550|"~     The goal of this clinical research study is to compare armodafinil and minocycline when~     given alone or in combination to learn which is better for controlling symptoms, such as the~     side effects of chemoradiation, when given to treat lung cancer.~   "
132753|NCT01317537|"~     Project Summary:~      An electronic personal health record (ePHR) could maximize patient/clinician collaboration~     and consequently improve patient self-management and related health outcomes. The purpose of~     the proposed project is to examine the feasibility, acceptability, and impact of an ePHR~     that has been modified using a patient- and family-centered approach and incorporates the~     experiences, perspectives, and insights of patients and family members actually using the~     system. Comparison of patients with the ePHR intervention to a group of care as usual~     patients will be performed. The investigators Specific Aims are: (1) To improve the~     application of patient- and family-centered care elements in an existing ePHR, based on~     feedback from a pilot study of patients and their families. The modified ePHR will be tested~     in a pilot group of patients with hypertension and their families. (2) To implement and test~     the effectiveness of the modified ePHR with patients being treated for hypertension by a~     team of physicians, mid-level practitioners, nurse clinicians, and support staff in two~     ambulatory settings. Outcome measures will include patient activation and perception of~     care, quantifiable biological markers, patient-physician communication, and congruence of~     treatment with guidelines, particularly medication management; (3) To monitor the shift in~     provider and support staff awareness and incorporation of patient- and family-centered care~     as a result of implementation of the ePHR using questionnaires and focus groups. If~     successful, this ePHR could be implemented in additional locations in the Southeast.~   "
132754|NCT01317524|"~     The purpose of this study is to compare the effects of homogenized, unhomogenized and~     skimmed milk on postprandial metabolism in healthy overweight men~   "
132755|NCT01317511|"~     Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase~     mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be~     to provide further insight into the responsiveness of the muscle protein synthetic machinery~     to food intake in relation to age.~   "
132756|NCT01317498|"~     The purpose of the study is to test the hypothesis that the addition of routine viral load~     testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral~     treatment (ART) in Vietnam will result in better clinical outcomes for patients.~   "
132757|NCT01317485|"~     The first objective (LOLA) of this integrated trial is to determine whether laparoscopic~     lavage leads to better clinical outcomes compared to sigmoidectomy in patients with~     perforated diverticulitis with purulent peritonitis in terms of mortality and major~     morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with~     anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with~     perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free~     survival. The study is designed as a multicenter and randomised trial.~   "
132758|NCT01317472|"~     Recent studies have demonstrated that patients with throat-related reflux often require~     twice daily proton pump inhibitor therapy to attain significant symptomatic improvement,~     with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release~     proton pump inhibitor requiring only once-daily dosing, it may provide LPR symptomatic~     relief comparable to that of twice daily dosing, yet be more readily approved by third party~     payers because of its once daily dosing requirements. It is hypothesized that, in patients~     with pharyngeal-probe proven throat reflux, there will be significantly greater improvement~     in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than~     those receiving placebo alone.~   "
132771|NCT01317303|"~     Neuroplasticity refers to the ability of the nerve cells to modify their structure or~     function in response to injury or insult, or other environmental stimuli, with these changes~     outlasting the period of exposure. Plasticity may be observed as short term or long term~     changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as~     excitability changes are demonstrated in the degree to which peripheral muscles are~     activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number~     of approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation~     (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation~     (TMS) and protocols that combine these two. In addition, participants will complete a~     computerised 'rotor pursuit task' designed to provide a measure of motor learning.~      The investigators aim to find the most efficacious (defined by greatest number of responders~     and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The~     investigators will expose the same participants to four excitatory conditioning stimulation~     paradigms, with each session separated by at least a week.~      Our hypotheses include:~      The four conditioning stimulation protocols should increase motor cortical excitability, the~     investigators therefore expect there to be a significant increase in participant MEPs, with~     a positive correlation in the increase ofMEP amplitude of the protocols. The investigators~     do however expect that due to the principles of homeostatic metaplasticity, that the~     protocols preceded by cTBS will show greater MEP change, due to the lowering of the~     threshold for LTP plasticity induction. In addition, the investigators expect that an~     increase in the motor learning manifest by the rotor pursuit task and for there to be a~     correlation in participants between the increase in MEP amplitude and the improvement in~     time on target (TOT) shown in the motor learning task (MLT).~   "
132759|NCT01317459|"~     Background: 50% of people with diabetes are living with too high blood sugars and increased~     risk of diabetes related complications together with poor quality of life. The need to~     improve diabetes care by better enabling patients to utilise their individual and local~     resources to self-manage the condition is widely recognized, yet there is a lack of access~     to evidence-based patient-centred healthcare interventions. At present the individual~     patient's judgement of own concrete situation mostly remains unexplored and insufficiently~     used in decision-making causing that problems perceived by the patient in living with the~     illness remain unrecognised and insufficiently resolved.~      Aim and Methods: Guided self-determination (GSD) is an educational method developed to~     promote patient autonomy, participation, skills building and intrinsic motivation. In this~     evidence-based group-intervention the main objective is to implement and evaluate GSD~     through a randomised controlled trial. GSD methods will be performed seven times for the~     intervention group. The control group will receive traditional out-patient consultations -~     'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The~     project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be~     highly cost-effective in preventing late complications and enhanced psychosocial health. GSD~     is presumably an intervention providing psychosocial support applicable in busy clinical~     practice.~      An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes~     centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College,~     and Bergen University to conduct this intervention and thus make the best possible use of~     interrelated knowledge within the issue.~   "
132760|NCT01317446|"~     The purpose of this study is to determine whether rinsing with an amine fluoride/stannous~     flouride mouthrinse in addition to daily tooth brushing is more effective than tooth~     brushing alone.~   "
132761|NCT01317433|"~     The aim of this study is to test the role of cycline in the prevention of acne-like skin~     rash in metastatic colorectal patients treated with Cetuximab and intensified FOLFIRI.~   "
132762|NCT01317420|"~     This study is a phase I, open-label, dose escalation trial to determine the maximum~     tolerated dose (MTD) of a new drug BI 836845 which blocks the insulin growth factor (IGF)~     pathway believed to be involved in cancer growth. BI 836845 will be administered for the~     very first time into cancer patients.~      The study will also look at the overall safety of the drug, and examine the drug levels in~     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the~     drug may have on tumours will also be examined (pharmacodynamics).~   "
132763|NCT01317407|"~     After an operation many patients are in a confused mental status at the intensive care unit.~     In this status they possibly fall out of their bed or pull out endotracheal tubes or central~     venous catheters accidentally. For this, they need permanently monitoring and control~     through intensive care personnel.~      The goal of the VIPSafe project is to develop robust techniques for automated patient~     monitoring, that rely on data from a small number of untethered sensors, which are~     nonetheless flexible enough to cope with a large variety of demands.~   "
132764|NCT01317394|"~     This study is a retrospective research in order to compare and analysis the risk factor,~     clinical manifestation and efficacy of albicans candidemia by pulling medical records. We~     hope that this retrospective research will let us understand the method of treatment and~     prevention of albicans candidemia in order to improve the quality of healthcare.~   "
132765|NCT01317381|"~     ICG- Leberfunktionstest versus neue Biomarker als prognostischer Marker bei~     intensivmedizischen Patienten~   "
132766|NCT01317368|"~     This study is conducted to evaluate different analgesic treatments effect following~     operation where the prostate gland is surgically removed.~      The different treatments the investigators wish to investigate is:~        1. Transversus Abdominis Plane (TAP) block.~           The TAP block is a rather new method, where a local anaesthetic is deposited between~          the two inner abdominal muscles. Between these muscles, the nerves that innervates the~          anterior part of the abdominal wall is situated.~        2. Wound infiltration~           In this method you deposit a local anaesthetic in the edges of the wound.~        3. Placebo~      No active local treatment is given.~      All patients who wish to participate will be allocated to one of three different treatment~     groups.~      Group 1:~      Will receive TAP block with a local anaesthetic and wound infiltration with saline.~      Group 2:~      Will receive wound infiltration with a local anaesthetic and TAP block with saline.~      Group 3:~      Will receive TAP block with saline and wound infiltration with saline.~      Beside this local treatment all patients will be given systemic Paracetamol (tablet) and~     Ibuprofen (tablet).~      In addition all patients will be given a pump containing morphine. The pump is connected to~     a button which the patient can activate when they experience pain. This enables the patient~     to control how much morphine he needs, following the operation.~      The hypothesis is that the TAP block is superior in reducing pain and thereby reducing~     morphine consumption compared to wound infiltration and placebo.~   "
132767|NCT01317355|"~     This study will assess the occurrence of multiple symptoms in cancer patients of 5 German~     university hospitals. Primary goal of the study is to assess the prevalence of multiple~     symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).~   "
132768|NCT01317342|"~     The purpose of this study is, in a phase II randomized trial, to test a newly developed~     machine perfusion technique of human liver allografts before transplantation.~      Ischemia-reperfusion injury is universal in organ transplantation and leads to varying~     degrees of graft dysfunction. Despite this fact, the preservation method in organ~     transplantation has been left unchanged for many years and remains simple static cold~     storage. Given the scarce donor supply, an increasing number of so called marginal or~     extended criteria donor organs have been used for liver transplantation, grafts which were~     previously rarely considered. In addition, allocation policy has changed in many countries,~     and livers are currently often distributed by the severity of the recipient's disease. As a~     result, transplant candidates present sicker, with higher MELD (Model for end stage liver~     disease) scores, at the time of transplant,and the risk of graft dysfunction or even failure~     due to reperfusion injury is high after the use of marginal livers in sick recipients.~      Machine liver perfusion techniques have been significantly improved during the past decade~     to decrease reperfusion injury, and a number of promising results show beneficial effects in~     various animal transplant models by either normothermic or hypothermic oxygenated continuous~     liver perfusion. These techniques generally require machine liver perfusion immediately~     after organ procurement. However, continuous perfusion has several drawbacks, including~     major logistic efforts and risk of organ damage during perfusion and transport.~      Our group, therefore, focused on the practicability of machine liver perfusion. We developed~     an endischemic hypothermic oxygenated perfusion (HOPE) concept through the portal vein only.~     This technique can be easily applied in the operation room shortly before transplantation of~     the recipient, thus after organ transport and back table preparation.~      Recently, the beneficial effect of a similar approach has been confirmed in human liver~     grafts by a phase I non randomized trial. These results prove feasibility and safety of an~     endischemic hypothermic machine perfusion approach and warrant further randomized studies.~   "
132772|NCT01317290|"~     The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and~     DHA) in human lipids by oral supplementation of ALA-rich linseed oil. In addition, the~     accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and~     physiological conditions (overweight, increased serum total cholesterol).~   "
132773|NCT01317277|"~     Methamphetamine (METH) is a debilitating and frequently abused substance that is often~     comorbid with HIV infection. HIV+ persons with current METH abuse or dependence (HIV+/METH+)~     have several characteristics, in addition to their substance use, that make them~     particularly susceptible to nonadherence to antiretroviral treatment (ART) including~     elevated rates of neurocognitive impairment, co-occurrence of psychiatric disorders, and~     unstable living situations. The investigators propose an intervention development study~     designed to address these potential mechanisms of nonadherence with the following Specific~     Aims: 1) To further develop and refine a personalized, automated, real-time, mobile phone,~     text messaging intervention (iTAB) designed to improve adherence to ART medications among~     HIV+/METH+ persons; 2) To evaluate the acceptability and effectiveness of a brief~     psychoeducation plus text messaging intervention (iTAB) as compared to psychoeducation alone~     (CTRL) for the improvement of objectively measured medication adherence among HIV+/METH+~     persons; and 3) To examine predictors of within-person trajectories of nonadherence using~     the longitudinal data collected over the study. In order to realize these aims, the~     investigators will leverage the infrastructure of two unique UCSD resources increasing~     likelihood of study success, impact, and innovation: 1) the Translational Methamphetamine~     AIDS Research Center (TMARC), which is a NIDA-funded center that focuses on the combined~     effects of METH and HIV infection, and 2) the California Institute for Telecommunications~     and Information Technology (Calit2), which conducts research on state-of-the-art wireless~     means of health promotion. Initially, the investigators will refine the iTAB intervention to~     ensure that it is user-centered and tailored to the needs of HIV+/METH+ persons via focus~     groups and rapid prototyping. Once refined, the proposed iTAB intervention will use text~     messages that are automated, scalable, personalized, interactive, flexible, and motivating.~     The investigators will assess the acceptability and effectiveness of iTAB in improving~     objectively measured adherence (i.e., MEMS caps) over a 6-week period via a pilot RCT with~     40 HIV+/METH+ assigned to the iTAB intervention and 20 HIV+/METH+ assigned to a~     psychoeducational control. Predictors of nonadherence including frequency of METH use,~     neuropsychological impairment, and mood will be examined to determine whether iTAB is better~     able to compensate for these factors associated with nonadherence as compared to CTRL.~     Further refinement to the iTAB intervention will be made in order to pursue a large-scale~     R01 using our tailored intervention.~   "
132774|NCT01317264|"~     The aim of this study is to investigate the potential disease preventive effects of~     β-glucans from oat and barley.~   "
132775|NCT01317251|"~     The aim is to study the effect of milk versus cheese on fecal fat excretion and blood~     lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control~     diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples~     will be collected before and after each period, and fecal samples will be collected for the~     last 5 days in each period.~   "
132776|NCT01317238|"~     The currently available stock of smallpox vaccine would be insufficient in the face of an~     incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are~     urgently needed because previous manufacturing methods using calf lymph are no longer~     acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea~     has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by~     infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,~     and immunogenicity of CJ-50300 in previously vaccinated healthy volunteers~   "
132777|NCT01317225|"~     The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone~     biweekly can reduce the incidence of preterm labor in patients with an episode of threatened~     preterm labor during the current pregnancy.~   "
132778|NCT01317212|"~     High-grade gliomas are the commonest primary malignant brain tumours in adults, affecting~     approximately 5000 people per year in the UK. Standard treatment comprises a combination of~     surgery, radiotherapy and chemotherapy; however this condition remains incurable and the~     average survival is approximately 18 months from diagnosis. There are a number of reasons~     for this. Firstly these tumours are highly invasive and involve important areas of brain~     making it impossible to remove them surgically or cure them with radiotherapy. In the~     majority of cases the tumour recurs within 2 to 3cm of the original site of tumour removal.~     Secondly, due to the presence of a barrier between the bloodstream and the brain, when drugs~     designed to kill tumour cells (chemotherapy) are given intravenously or orally, they~     frequently do not reach the tumour at a sufficient dose to have a beneficial effect. As the~     chemotherapy dose has to be very high for a sufficient dose to reach the tumour,~     drug-related side-effects are common.~      Laboratory studies demonstrate that glioma tumour cells are sensitive to a number of~     different chemotherapies, including carboplatin. When given intravenously however,~     carboplatin does not reach a sufficient concentration in the tumour to have a beneficial~     effect. However, studies have shown that carboplatin can be infused directly into the brain~     at a concentration that is highly toxic to tumour cells, but not to normal brain tissue.~     Using very small tubes implanted around the tumour, the investigators are able to infuse~     carboplatin reliably and repeatedly into the area where tumours typical recur. In this~     study, the investigators intend to evaluate the safety of this approach and determine the~     optimal dose of carboplatin to administer. It is hoped that this study will also provide~     evidence of improved survival for patients with high-grade glioma.~   "
132779|NCT01317199|"~     This research is being done to test an investigational product called Muscadine Plus in the~     treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or~     brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific~     antigens (PSA) level.~   "
132780|NCT01317186|"~     In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very~     common and also they are one of the leading causes of morbidity in these population. FGF23~     is a novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23~     increase is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to~     evaluate this hypothesis.~   "
132781|NCT01317173|"~     Chronic kidney disease is a progressive disorder that has been influenced with many factors.~     Most of the patients has altered Ca P metabolism and these dis orders are the contributing~     factors of the disease progression. It has been recently documented that FGF23 and Klotho~     are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the~     impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.~   "
132795|NCT01316965|"~     Postoperative delirium is common in the elderly and is associated with a significant~     increase in mortality, complications, length of hospital stay and admission in long care~     facility. Several interventions have proved their effectiveness to prevent it but their~     combination within a multifaceted intervention needs to be assessed using rigorous~     methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of~     a multifaceted program on the prevention of postoperative delirium in elderly.~   "
132883|NCT01315808|"~     The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and~     normal population with risk factors of developing type 2 DM. There is no known diabetes~     model for predicting incident diabetes in an individual which takes into account the rate of~     change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians~     lead time needed to implement the Diabetes Prevention Program measures.~   "
132884|NCT01315795|"~     An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide~     autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease,~     including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.~   "
132782|NCT01317160|"~     This prospective randomized study aims to determine whether intermittent pneumatic~     compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in~     plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote~     healing of sutured acute Achilles tendon ruptures.~      At two weeks post surgery, the IPC intervention will be ended and both patient groups will~     be immobilized in an orthosis until follow-up at six weeks.~      The endpoint of the first part of the study is VTE events. The primary outcome will be the~     DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by~     two ultrasonographers masked to the treatment allocation. Secondary outcome will be the~     DVT-incidence at 6 weeks.~      1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis~     (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic~     pulmonary embolism detected by computer tomography.~      The endpoint of the second part of the study is tendon healing quantified at 2 weeks by~     microdialysis followed by quantification of markers for tendon repair.~      The endpoint of the third part of the study is the functional outcome of the patients at one~     year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total~     Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and~     EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.~   "
132783|NCT01317147|"~     The morbidly obese frequently present with mood and anxiety disorders, which are often~     treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators~     hypothesized that gastric bypass surgery would decrease the absorption of SRI. The~     investigators also wished to determine whether a reduction in SRI levels would increase the~     likelihood of worsening depressive symptoms.~   "
132784|NCT01317134|"~     The objectives of the current study are to identify and evaluate new prognostic non-invasive~     and serological markers in patients with pulmonary hypertension. The focus will be on~     L-arginine metabolism and to clarify its influence on endothelial function.~   "
132785|NCT01317121|"~     Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase~     and First Episode of Schizophrenia~   "
132786|NCT01317108|"~     Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed~     to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as~     stratification criteria and randomized high-risk patients to chemotherapy versus~     observation; low-risk patients remained without any systemic therapy. The trial was designed~     to answer two principle questions:~        1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective~          multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who~          are candidates for being spared necessity and burden of adjuvant chemotherapy?~        2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?~   "
132787|NCT01317095|"~     The investigators are conducting this research to compare two different methods of closure~     of the sternum after cardiac surgery to determine if one method is better than the other.~     Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs~     to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid~     sternal closure system with equivocal results; however, the outcomes of these two methods~     have never been investigated in a randomized study. Thus, the investigators are conducting~     this study to compare two different methods of closure if one method demonstrates any~     recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation~     with Sternalock or stainless steel wire closure. Recover benefit will be measured by~     postoperative intubation time, length of intensive care unit stay, and overall postoperative~     length of stay~   "
132788|NCT01317082|"~     The primary objective is to test the hypothesis that the use of the Pressure Right device in~     combination with ondansetron and dexamethasone would result in a lower incidence of~     postoperative vomiting (emesis) than the combination of antiemetic therapy alone.~   "
132789|NCT01317069|"~     Through clinical practice, to explore if the application of Fluorouracil implant could~     effectively delay the local tumor recurrence and improvement the postoperative survival time~     in patients with gallbladder cancer and bile duct cancer.~   "
132790|NCT01317030|"~     The objective of this study is to evaluate tears between habitual contact lens wearers and~     non contact lens wearers using a Schirmer Strip for tear collection.~   "
132791|NCT01317017|"~     IFN-gamma is a central player in the development of psoriasis lesions, which can be involved~     a variety of cellular processes in the skin. Dendritic cells are important cells in driving~     inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis.~     Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs~     that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize~     that the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing~     T cells.~   "
132792|NCT01317004|"~     The purpose of this study is to evaluate the change in patient-reported treatment~     satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care,~     using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for~     Medication (TSQM-9).~   "
132793|NCT01316991|"~     Investigators are interested in learning how appetite responds after chewing gum.~      In this research study subjects will be asked to eat a lunch meal provided at our Center.~     After eating the lunch meal, subjects will answer questions describing their feelings of~     hunger, thirst and desire to eat every 30 minutes for 3 hours.~      Blood will be drawn throughout the study period to determine how chewing gum impacts certain~     hormones released from your intestine after eating and therefore how they influence your~     appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two~     study visits, subjects will chew gum during specific times. One study visit will not include~     chewing gum.~      After three hours, there will be a snack to eat as much as desired followed by one more set~     of questions and blood draw.~      All study visits will take approximately 4 ½ hours.~   "
132794|NCT01316978|"~     This study is designed to assess bioequivalence between one test and two reference~     formulations used for treatment of headaches and temporary relief of pain.~   "
132825|NCT01316562|"~     The purpose of this study is to determine the predictive value of standardized cognitive~     tests performed in health examination centres for the diagnosis of Alzheimer's disease and~     related disorders among adults aged 65 years and older with a subjective memory complaint.~   "
132796|NCT01316952|"~     A cluster of reports of hypersensitivity reactions among patients who switched from~     carvedilol (immediate release formulation, referred to hereafter as carvedilol) to~     carvedilol extended release was received during the initial post-launch period of carvedilol~     extended release. In follow up to this observation, product labeling for both agents was~     updated and a nested case control study was subsequently conducted to examine the risk of~     serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among~     patients who used carvedilol extended release compared to carvedilol and separately compared~     to other long acting beta(β)-blockers. This proposed analysis is an update to the previously~     conducted analysis using the same database, LabRx, now containing 2 additional years of~     data, which should provide a larger number of carvedilol extended release exposed subjects.~   "
132797|NCT01316939|"~     A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of~     two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission~     over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the~     Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response~     (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK~     sponsored induction study. The primary endpoint will be proportion of subjects in remission~     at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical~     laboratory parameters including liver function tests, vital signs and electrocardiogram.~     Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes~     assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ),~     SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and~     disability.~   "
132798|NCT01316926|"~     The study is prospective, open, randomized, crossover in steady state and the volunteers~     received multiple doses of the drug test and reference (two periods of drug administration).~   "
132799|NCT01316913|"~     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group~     study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation~     Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via~     HandiHaler when administered once-daily over a 24-week treatment period in subjects with~     chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at~     Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization~     visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study~     visits. A follow-up phone contact for adverse event assessment will be conducted~     approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total~     duration of subject participation in the study will be approximately 26 weeks. The primary~     measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced~     expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by~     adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.~   "
132800|NCT01316900|"~     This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group~     study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation~     Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via~     HandiHaler when administered once-daily over a 24-week treatment period in subjects with~     chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at~     Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization~     visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study~     visits. A follow-up phone contact for adverse event assessment will be conducted~     approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total~     duration of subject participation in the study will be approximately 26 weeks. The primary~     measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced~     expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by~     adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.~   "
132801|NCT01316887|"~     The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse~     events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue~     medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects~     with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be~     evaluated. A placebo arm is included to evaluate these products compared to an inactive~     control.~   "
132802|NCT01316874|"~     This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with~     carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus~     Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple~     courses of intravesical treatment.~   "
132803|NCT01316861|"~     The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2~     Diabetic Patients Using Two Different Formulations of Acarbose 50mg.~   "
132804|NCT01316848|"~     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose~     of 1.5 mg tivozanib in normal healthy subjects.~   "
132805|NCT01316835|"~     This study will evaluate whether the addition of sitagliptin treatment provides additional~     decrease in HbA1C levels and increase in goal attainment in patients with inadequate~     glycemic control on their current oral anti-glycemic therapy in real world practice.~   "
132806|NCT01316822|"~     This is a Phase 1 study during which patients with advanced cancer will receive~     investigational study drug ARRY-382. Patients will receive increasing doses of study drug in~     order to achieve the highest dose of the study drug possible that will not cause~     unacceptable side effects. Patients will be followed to see what side effects and~     effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients~     from the US will be enrolled in this study.~   "
132826|NCT01316549|"~     Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal~     of this study is to determine what causes some children to have different drug~     concentrations of fludarabine in their bodies and if drug levels are related to whether or~     not a child experiences severe side-effects during their bone marrow transplant. The~     hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in~     pediatric bone marrow transplant patients and that high levels may cause severe~     side-effects.~   "
132827|NCT01316536|"~     The study is designed to analyze the use of music therapy to decrease pain and agitation in~     intubated ICU patients.~   "
132807|NCT01316809|"~     Background:~      - AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called~     mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s~     energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR~     protein and is expected to be more effective than prior mTOR inhibitors. However, more~     research is needed to determine its safety and effectiveness in treating brain tumors known~     as gliomas that have not responded to standard treatments.~      Objectives:~      - To evaluate the safety and effectiveness of AZD8055 in individuals with gliomas that have~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with gliomas that have not~     responded to standard chemotherapy, surgery, or radiation.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and tumor imaging studies.~        -  Participants will be separated into two treatment groups: one group that will receive~          surgery to remove the glioma and one that will not have surgical treatment.~        -  Participants in the nonsurgical treatment group will take AZD8055 by mouth daily for a~          42-day cycle of treatment. Participants will keep a diary to record doses and keep~          track of any side effects.~        -  Participants in the surgical treatment group will take AZD8055 by mouth daily for 7~          days, and then will have tumor removal surgery. At least 3 weeks after surgery,~          participants will resume doses of AZD8055 and will continue to take the drug for as~          long as the tumor does not recur.~        -  During treatment, participants will have regular visits to the clinical center,~          involving frequent blood and urine tests and other examinations to monitor the effects~          of treatment. Participants will have imaging studies to study the cancer's response to~          the treatment.~        -  Participants will continue to have cycles of treatment for as long as the treatment~          continues to be effective and the side effects are not severe enough to stop~          participation in the study....~   "
132808|NCT01316796|"~     Background:~      - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease,~     thalassemia, and other red blood cell disorders. In these disorders, red blood cells break~     down earlier than normal, which researchers suspect may cause or contribute to the~     development of leg ulcers; however, the exact cause is unknown, and current therapies are~     not very effective. Researchers are interested in determining if a research cream made with~     sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels,~     may speed up the healing of skin ulcers.~      Objectives:~      - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment~     for chronic leg ulcers in individuals with sickle cell disease or other red blood cell~     disorders.~      Eligibility:~      - Individuals at least 18 years of age who have sickle cell disease or another red cell~     disorder and have had a leg ulcer for more than 4 weeks.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and an examination of the ulcer, including x-ray of the leg(s) with the ulcer~          and swabs from the wound.~        -  Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with~          the following procedures:~        -  Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the~          affected leg, imaging studies (magnetic resonance imaging and infrared photography),~          thermo-patch application to monitor temperature changes, measurements of blood flow in~          the skin, and questionnaires about pain and quality of life. An optional skin biopsy~          may also be conducted with samples taken near the skin ulcer~        -  Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood~          draws will be conducted before application and then regularly for up to 6 hours after~          application of the cream. Thirty minutes after the research cream is applied,~          participants will have imaging studies of the treated leg and measurements of pain~          levels and blood flow.~        -  Day 4: Participants will have a blood draw and temperature recordings taken.~        -  Day 5: Participants will have the research cream applied and the same imaging studies~          as before, and will be discharged for care at home.~        -  For the following 3 weeks, participants will come to the clinical center twice a week~          to have the research cream applied to the leg ulcer and tests performed by the study~          researchers.~        -  For the fourth and final week, participants will return for additional cream treatment~          sessions, imaging studies, blood draws, and other tests as directed by the study~          researchers.~        -  Study participation will end in the following week (week 5). Subjects will come for a~          final visit one month after the end of the study.~   "
132809|NCT01316783|"~     Background:~      - African Americans have one of the highest rates of type 2 diabetes in the United States,~     and often have other medical problems related to obesity and cardiovascular disease. These~     conditions have various risk factors, including high blood sugar levels, high cholesterol~     levels, and insulin resistance. However, these risk factors have not been studied very~     closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan~     Africa migrant populations. Researchers are interested in conducting a genetic study on~     obesity, adult-onset diabetes, heart disease, and other common health conditions in~     individuals with African ancestry.~      Objectives:~      - To collect genetic and non-genetic information from individuals with African ancestry to~     study common health conditions related to obesity, adult-onset diabetes, and heart disease.~      Eligibility:~      - Individuals at least 18 years of age who self-identify as African American,~     Afro-Caribbean, or migrants from sub Saharan Africa.~      Design:~        -  Participants will undergo a physical examination and will provide a blood sample for~          study.~        -  Participants will also answer questions about personal and family medical history and~          current lifestyle behaviors.~        -  No treatment will be provided as part of this protocol.~   "
132810|NCT01316770|"~     Background:~      - Sj(SqrRoot)(Delta)gren s syndrome is an autoimmune disease (where the immune system~     attacks normal body tissues) that affects the salivary glands. Many people with~     Sj(SqrRoot)(Delta)gren s syndrome are not able to make enough saliva because their salivary~     glands are inflamed. The dry mouth that results can interfere with daily activities and can~     lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the~     parotid glands can improve saliva production in people with to Sj(SqrRoot)(Delta)gren s~     syndrome, but current treatment practices may provide only temporary relief. Researchers are~     interested in studying the effectiveness of stronger corticosteroid injections (using~     dexamethasone) to determine how the corticosteroid treatment actually works.~      Objectives:~      - To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva~     production in individuals with primary Sj(SqrRoot)(Delta)gren s syndrome.~      Eligibility:~      - Women between 18 and greater of age who have been diagnosed with primary~     Sj(SqrRoot)(Delta)gren s syndrome, and have had a biopsy of the minor salivary glands in the~     past 5 years that shows a moderate level of inflammation.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and salivary gland biopsies. Participants will also be screened~          with tests of saliva flow production and evaluation of the salivary ducts and glands,~          and will complete questionnaires about dry mouth symptoms.~        -  At the first treatment visit, participants will receive an injection of dexamethasone~          into one parotid gland and an injection of saline into the other gland. After the~          injections, participants will provide a blood sample to test the level of dexamethasone~          in the blood.~        -  Two weeks after the first treatment, participants will return for an evaluation visit~          to have saliva flow rate measurements taken, and will complete a questionnaire about~          dry mouth symptoms.~        -  Four weeks after the first treatment, participants will have a second treatment for~          each parotid gland, with the same tests and questionnaires as before.~        -  Participants will have additional evaluation visits 6 and 8 weeks after the first~          treatment visit, with a followup telephone call approximately 6 weeks after the last~          dexamethasone treatment visit.~   "
132811|NCT01316757|"~     This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and~     erlotinib hydrochloride together works in treating patients with metastatic or recurrent~     squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving combination chemotherapy together with cetuximab and~     erlotinib hydrochloride may kill more tumor cells.~   "
132812|NCT01316744|"~     RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is~     not yet known whether ketamine hydrochloride given together with the best pain management is~     more effective than a placebo given together with the best pain management in treating~     neuropathic pain in patients with cancer.~      PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together~     with the best pain management to see how well it works compared with giving a placebo~     together with the best pain management in treating cancer patients with neuropathic pain.~   "
132852|NCT01316211|"~     A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal~     stenosis with concomitant low back pain by decompression with and without additional~     stabilization using the coflex® Interlaminar Technology~   "
132813|NCT01316731|"~     Rationale: Proteins released from muscle during and shortly after exercise, often referred~     to as myokines, may be central to our understanding of the cross-talk during and after~     exercise between skeletal muscles and other organs, in particular the liver. So far only a~     few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the~     role of these several known myokines in developing insulin resistance, revealing new~     putative myokines might provide valuable information and a direction for future research on~     the pathogenesis and treatment of type 2 diabetes mellitus.~      Objective: The objective of the present study is to identify novel myokines, expression of~     which is altered in skeletal muscle after a single bout of exercise.~      Study design: experimental study. Study population: Ten healthy, male subjects between 40~     and 60 years of age and BMI < 30 kg/m2, will participate in this study.~      Intervention: A single exercise bout that consists of one hour one-legged cycling on a~     adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as~     control for the exercising leg.~      Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle~     after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels~     of selected proteins after exercise.~   "
132814|NCT01316718|"~     The purpose of the trial is to define the clinical benefit and possible mediators of the~     benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.~      The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers~     reflecting mast cell activation and small bowel tone.~   "
132815|NCT01316705|"~     This study aims to determine if early embryonic development, in D2 and D3 and the~     blastocyst, is compromised by the fine morphology of sperm nucleus. This will draw the IMSI,~     in which sperm will be chosen using the classification MSOME and ICSI in which sperm~     morphology is elected with less magnification. Both techniques are performed in oocytes of~     donor , being the coohorte used for both techniques picked at random. All courses will begin~     as a crop sequence, using the criteria of the IVF laboratory. Transfers will be made in~     blastocyst stage (D5 or D6), except in cases where the number of fertilized is less than 6~     or fewer than 6 embryos of acceptable quality in D3, which would transfer the same D3 . With~     donor oocytes, the quality of these need not be compromised and to perform the same~     technique in all oocytes results in pure transfers with both techniques. It allows us to~     compare results in term of pregnancy, implantation and early abortion rate, as well as~     embryo quality.~   "
132816|NCT01316692|"~     RATIONALE: Aurora A kinase inhibitor MLN8237 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying how well Aurora A kinase inhibitor MLN8237 works in~     treating patients with unresectable stage III-IV melanoma~      Funding Source - FDA OOPD~   "
132817|NCT01316679|"~     Specific urine proteases or groups of these enzymes can be reliable biomarkers and an~     effective gauge of response to therapy in patients with hepatocellular carcinoma.~   "
132818|NCT01316666|"~     The autonomic or automatic nervous system helps control blood pressure. Diseases of the~     autonomic nervous system may result in a drop in blood pressure on standing in many cases~     leading to fainting. Diseases that affect the autonomic nervous system include pure~     autonomic failure, multiple system atrophy and Parkinson's disease, and can present with~     very similar symptoms and it is sometimes difficult to determine an exact diagnosis. The~     purpose of the study is to find out if the blood pressure response from taking a single dose~     of the medication atomoxetine can help in the diagnosis of these diseases.~   "
132819|NCT01316653|"~     The purpose of this study is to conduct a randomized controlled trial that examines how a~     family based, community centered intervention effects early childhood BMI trajectories.~   "
132820|NCT01316627|"~     Body Dysmorphic Disorder (BDD) is a disabling condition that until recently has been largely~     ignored. Sufferers of BDD worry excessively and unreasonably about some flaw in their~     appearance that may be minimal or even nonexistent. These internalized body image~     distortions prompt sufferers to constantly check the perceived defects in mirrors, seek~     reassurance of their images from others, obtain unnecessary cosmetic and/or dermatological~     procedures, and even conduct self-surgeries. These obsessive concerns and compulsive~     behaviors cause significant emotional distress and often significantly interfere with global~     functioning. Currently, cognitive-behavioral therapy (CBT) in conjunction with~     psychopharmacology is the preferred treatment for BDD. In addition, two relatively new~     exposure techniques (mirror retraining method and crooked mirror externalization~     therapy) that utilize mirrors to exaggerate the patient's imagined defect appear to~     increase the benefits of CBT. However, the treatment efficacies of these relatively novel~     methods have not been rigorously tested or methodologically compared. Although six out of~     seven patients treated with crooked mirror externalization therapy at the Westwood Institute~     for Anxiety Disorders, Inc. demonstrated significant gains, the small sample size does not~     allow for any significant generalizations. Thus, the goals of this project are: 1) to~     determine the efficacy of exposure therapy that utilizes mirrors in the treatment of BDD,~     and 2) to evaluate the level of effectiveness of the mirror retraining method versus the~     crooked mirror externalization therapy. To accomplish these goals, each subject taking part~     in the study will do the following. They will go through an in-depth interview with the~     study physician, Dr. Kagan, and complete several clinical assessment questionnaires to~     confirm that they have BDD according to the Diagnostic and Statistical Manual of Mental~     Disorders - Fourth Edition (DSM-IV). They will be assessed by the study independent~     evaluator and complete several paper-and-pencil tests to determine the severity of the BDD~     and if they have any cognitive difficulties. The subject will participate in 3 weeks of CBT~     with either the mirror retraining method or the crooked mirror externalization therapy.~     After the CBT, we will repeat the clinical assessment questionnaires and neurocognitive~     testing. From the difference between the before and after scores on all these tests, we will~     determine if there has been any change in the subject's BDD symptoms, and if so, the level~     of effectiveness between the mirror retraining method and the crooked mirror externalization~     therapy.~   "
132821|NCT01316614|"~     The purpose of this study is to determine that there is no difference in final diagnosis of~     FNA specimens without a stylet, compared to using a stylet, when examined by a skilled~     cytopathologist.~   "
132822|NCT01316601|"~     Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas~        -  Trial with medicinal product~   "
132823|NCT01316588|"~     The purpose of this study is to measure the time to recolonization intraoperatively after~     preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence~     of differential bacterial growth with or without plastic adhesive drape on the chest as well~     as with or without microbial sealant on the leg.~   "
132824|NCT01316575|"~     The purpose of this study is to determine whether prophylactic nasal continuous positive~     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative~     pulmonary function following elective bowel surgery. The investigators hypothesize that one~     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)~     when compared to the standard treatment of low flow oxygen applied by face mask.~   "
133263|NCT01310699|"~     We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high~     definition white light colonoscopy will detect an increased number of nonpolypoid (flat and~     depressed) colorectal neoplasm.~   "
132828|NCT01316523|"~     Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's~     Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome.~      Rituximab is effective as a single agent and in combination with chemotherapy for indolent~     Non-Hodgkin's Lymphoma.~      The purpose of this study is to see how well giving lenalidomide together with rituximab~     works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.~      Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until~     the disease progresses, unacceptable side effects or after twelve cycles if the patient is~     responding well.~      Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy,~     if patients respond well to treatment, patients will receive a second course of Rituximab.~      Blood samples will be collected to assess how the immune system is functioning.~   "
132829|NCT01316510|"~     Infants born with gastroschisis usually require surgery shortly after birth. After surgery~     the intestine is often unable to digest human milk or formula for weeks or months. During~     this time the baby has to remain in the hospital to receive special nutrition through an IV.~     How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that~     appear to have beneficial effects on digestion. This study will test whether giving~     probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the~     intestine to be more like those of a healthy breast-fed baby.~   "
132830|NCT01316497|"~     The purpose of this study was to investigate if repeated inflation of a blood pressure cuff~     applied around one leg causing mild ischemia (remote ischemic preconditioning) could~     protect children operated for congenital heart disease from developing acute kidney injury.~   "
132831|NCT01316484|"~     The primary objective of the study is to evaluate how patients with gastroparesis interpret~     the instructions, item content, and response options of a daily diary questionnaire designed~     to assess the key symptoms of gastroparesis.~   "
132832|NCT01316471|"~     The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet)~     behavioral program to reduce pain and improve functioning in children and adolescents with~     chronic pain. We hypothesize that children and adolescents in families that receive the~     web-based behavioral program will report reduced pain levels and improved daily functioning~     compared to children and their parents who receive online patient education.~   "
132833|NCT01316458|"~     To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with~     rising PSA following radical prostatectomy, to produce a sustained biochemical response~     during the first 6 months of treatment.~   "
132834|NCT01316445|"~     Approximately 3 million individuals suffer from epilepsy in America alone and about 200,000~     new cases of epilepsy in America are diagnosed each year (Epilepsy Foundation, 2005).~     Epilepsy can be defined as a condition in which a person has recurrent, unprovoked seizures.~     Prolonged or back-to-back repetitive seizures, known as acute repetitive seizures (ARS),~     are medical emergencies. ARS can occur unexpectedly, a circumstance for which quick and~     efficient antiepileptic drugs are needed for household and prehospital use. Currently,~     benzodiazepines are the antiepileptic drug of choice when dealing with ARS because they are~     proven to be efficient and take little time to work. Benzodiazepines can be administered by~     mouth, by vein via a needle (intravenously; IV), rectally, between the cheek and gum~     (buccally), or in the nose (intranasally; IN). The nasal formulation is not yet~     FDA-approved. The rectal treatment route has been commonly used for acute seizure treatment~     in past years, but recent studies propose that the nasal route for benzodiazepines may be~     better overall for home treatment and easier to administer (see Wermeling, 2009). For many~     out of hospital situations, nasal benzodiazepines can be more convenient and more~     comfortable than rectal treatment. In addition to the above benefits, nasal benzodiazepines~     are rapidly absorbed by the blood vessels in the nose and the time of drug administration~     and cessation of seizures may thus be reduced using nasal routes. This study sets out to~     characterize how fast buccal and nasal treatments begin to work on the brain by monitoring~     brain waves during administration of the drug, and to determine whether nasal or buccal~     administration is best.~   "
132835|NCT01316432|"~     The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous~     subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.~   "
132836|NCT01316419|"~     This observational study is designed to evaluate the effects of Twynsta tablets with life~     style modifications on blood pressure, quality of life, and other risk factors in Korean~     patients with hypertension in a routine clinical practice setting.~   "
132837|NCT01316406|"~     The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients~     with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In~     part I, the safety and plasmatic levels of the active ingredient and its metabolite will~     allow to determine the most appropriate and beneficial dose for the second part of the~     study. In Part II, the efficacy of ATH008 cream in reducing the number of patients~     presenting PPES grade 2/3 secondary to capecitabine therapy following a four times daily~     application will be tested.~   "
132838|NCT01316393|"~     In the present study with a randomized, cross-over, blind, placebo controlled design, the~     effects of a salivary substitute product and a new mucoprotective product with similar~     mechanisms of action but with different composition and characteristics will be evaluated in~     cancer patients suffering from xerostomia.~   "
132839|NCT01316380|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium~     compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be~     delivered via Respimat inhaler and will be examined on top of maintenance inhaled~     corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will~     be assessed by measuring the effects on lung functions, effects on lung exacerbations,~     effects on asthma control and numbers of adverse events.~   "
132853|NCT01316198|"~     The objective of the study was to investigate the influence of a intervention with lutein~     und zeaxanthin from crucifers on the optical density of the macular pigment of patients with~     non exudative age-related maculopathy. It is hypothesized that the applied study beverage~     elevates plasma concentrations of the administered xanthophylls and the optical density~     after 4 weeks of intervention.~   "
132854|NCT01316185|"~     The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy~     and safety of 2 dose regimens in patients with chronic HDV.~   "
132840|NCT01316367|"~     BACKGROUND: Individual health education is considered to be essential in the overall care of~     patients with type 2 diabetes (DM2), although there is some uncertainty regarding its~     metabolic control benefits. There have been very few randomized studies on the effects of~     individual education on normal care in DM2 patients with a control group, and none of these~     have assessed the long-term results. Therefore, this study aims to use this design to assess~     the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational~     Diagnosis, and Evaluation) education model in the metabolic control and the reduction of~     cardiovascular risk factors, in patients with type 2 diabetes.~      METHODS: An open community randomized clinical trial will be carried out in 8 urban~     community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2~     will be randomized in two groups: PRECEDE or conventional model for health promotion~     education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI),~     blood pressure, lipids and control criteria during the 2-year follow-up period.~   "
132841|NCT01316354|"~     Sedentary lifestyles and increasing obesity are main causes of the global increase in the~     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,~     particularly composition of carbohydrate play also a significant role. The glycemic index~     (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich~     food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels~     of satiety hormones. In contrast, our knowledge of the physiological effects of~     arabinoxylans (AX), which constitute a substantial part of dietary fibre in cereal products,~     is limited. The investigators also lack a deeper understanding of the importance of whole~     grain (whole grain with whole kernels, and purified dietary fibre) in relation to Mets and~     T2DM.~      Hypothesis: The composition of dietary carbohydrates can be designed so that they improve~     the glycemic and insulinaemic responses and increase satiety feeling. This can be detected~     in metabolic parameters in subjects with Mets.~      The aim of our study is in subjects with Mets to compare the effect of acute consumption of~     bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with~     a (d) control group with consumption of white bread (WB).~      The primary endpoint is GI. Secondary endpoints are the following items: glycemic load,~     insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric~     emptying, and metabolomics. Also satiety feeling will be measured.~      This project will improve opportunities for identifying and designing foods with low GI that~     is particularly suited to people who are at high risk of developing T2DM. The investigators~     also expect to gain a greater understanding of the metabolic fingerprint, as seen after~     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods~     affect health by altering metabolic processes. This will give us a deeper insight into the~     metabolic processes that are necessary for maintaining normal glucose homeostasis.~   "
132842|NCT01316341|"~     the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple~     oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to~     Chinese female and male patients with type 2 diabetes will be investigated.~   "
132843|NCT01316328|"~     The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase~     II single-arm study. The use of a single dose tumor bed is expected to be very effective~     in terms of tumor control, but it could increase the incidence of radiation induced~     erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as~     well as a reduced detoxification of the damage caused by oxidative stress could explain the~     increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this~     reason the investigators decided to investigate SNPs of genes involved in antioxidant and~     DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51.~      The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high~     risk, respectively, (groups were identified based on the absence/presence of the above~     polymorphisms alone or in combination), thus the minimum sample size was 56 patients with~     α=0.05, 2-tailed test and a power of the study of 80%.~   "
132844|NCT01316315|"~     The purpose of this study is to determine whether a single IV dose of N6022 will have a~     significant bronchoprotective effect, compared with placebo, during methacholine challenge.~   "
132845|NCT01316302|"~     This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the~     symptoms of Generalized Social Anxiety Disorder (SAD).~   "
132846|NCT01316289|"~     This prospective case series will essentially examine the influence of reduction quality on~     the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures~     treated with plate fixation.~      The plates used in this trial can be chosen according to the preferences of the surgeon.~   "
132847|NCT01316276|"~     The purpose of this study is to evaluate the long term safety and tolerability of Arikayce~     in Cystic Fibrosis patients. This long-term, open-label, multi-cycle extension study will~     enroll subjects who have successfully completed study TR02-108, were compliant with the~     study protocol, and did not meet any of the listed study discontinuation criteria. The~     safety and tolerability of Arikayce will be evaluated for up to approximately 2 years.~   "
132848|NCT01316263|"~     The purpose of this study is to evaluate the tumor response of stable disease (SD), partial~     response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid~     Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal~     Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα)~     mutations and patients with GIST not harboring PDGFRα mutations.~   "
132849|NCT01316250|"~     The results of the International Randomized Study of Interferon and STI571 (IRIS) trial~     indicate that in patients with chronic phase CML treated with first line imatinib,~     achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is~     associated with a significantly better progression-free survival (PFS).~      Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib~     resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in~     patients with previously untreated chronic phase CML, nilotinib results in a faster and~     higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet~     restriction and much higher financial cost.~      The primary objective of this study is to evaluate the ability of imatinib to maintain a~     complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of~     first-line treatment with nilotinib.~   "
132850|NCT01316237|"~     A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the~     Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve~     Subjects with Chronic Hepatitis C Virus Infection.~   "
132851|NCT01316224|"~     Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of~     participants with moderate or severe psoriasis. The purpose of this study was to describe~     the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to~     evaluate adalimumab efficacy and safety profile.~   "
132857|NCT01316146|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from diseases caused~     by germs or toxic substances. They work by binding those germs or substances, which stops~     them from growing and causing bad effects. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including tumor cells or cells~     that are infected with germs. Both antibodies and T cells have been used to treat patients~     with cancers: they both have shown promise, but have not been strong enough to cure most~     patients. Investigators hope that both will work better together.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. Investigators now want to see if~     they can attach a gene to T cells that will help them do a better job at recognizing and~     killing lymphoma cells.~      The new gene that investigators will put in T cells makes an antibody called anti-CD30. This~     antibody sticks to lymphoma cells because of a substance on the outside of the cells called~     CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been~     strong enough to cure most patients.~      For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this~     way, it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells seem~     to kill some of the tumor, but they don't last very long and so their chances of fighting~     the cancer are unknown.~   "
132858|NCT01316133|"~     This study is to evaluate efficacy and safety of tacrolimus with steroid by observing~     remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid~     monotherapy.~   "
132859|NCT01316120|"~     Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our~     objective is to simplify the method of collection of female genital tract specimens by~     determining if vaginal dry swabs are as accurate as the standard transport medium for HPV~     diagnosis.~   "
132860|NCT01316107|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
132861|NCT01316094|"~     This study is to assess the effect of renal function on the efficacy and safety of ASP1941~     in type 2 diabetic patients with mild to moderate renal impairment.~   "
132862|NCT01316081|"~     In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are~     common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly,~     antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines.~     Moreover, antioxidants reduce oxidative stress which influences endothelial function and~     might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore,~     overweight children and adults have a markedly increased risk for iron deficiency. The~     mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that~     the elevated inflammatory status associated with obesity increases circulating hepcidin and~     this contributes to iron deficiency. Weight reduction has been shown to be associated with~     reduced inflammation and serum hepcidin concentrations, and an improved functional iron~     state. Thus, reducing inflammation in obese children may improve iron metabolism and reduce~     their risk of iron deficiency.~      Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic~     risk factors in obese children during weight loss may be enhanced by supplementation with~     antioxidants.~      The aim of the present study is to investigate the effect of 4-month antioxidant~     supplementation on subclinical inflammation, hepcidin, iron status and components of the~     metabolic syndrome in overweight children undergoing an outpatient weight-loss program.~      Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation~     will reduce oxidative and inflammatory stress associated with obesity to a greater extent~     than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It~     will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve~     metabolic and cardiovascular risk factors.~      Subjects The investigators plan to enroll 50 children who are participants in outpatient~     weight-loss programs in the German part of Switzerland. Enrollment will be done with the~     agreement and assistance of the physician supervising the weight-loss program, and the~     timing of the study measurements will be incorporated within the existing program schedule.~     It is anticipated that the baseline blood sample for this study will be obtained from the~     regular baseline venipuncture for the weight-loss study. Criteria for participation include~     age between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion~     criteria include major medical illnesses, including gastrointestinal, inflammatory, bleeding~     and/or endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g.~     vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of~     chronic medications or vitamin/mineral antioxidant supplements.~      Study design The study will be a double-blind, randomized, placebo-controlled intervention~     trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo~     (P) supplement. If it is necessary to enroll children from different weight-loss programs,~     then randomization will be stratified by program. During the 4-month weight loss period, the~     AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU),~     and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each~     evening with diner, whereas the P group will consume identical-appearing placebo~     supplements.~   "
132863|NCT01316068|"~     Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary~     albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies~     demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no~     data concerning Chinese population is available. The investigators aim to provide evidence~     of effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the~     investigators also test the hypothesis that sequential administration of intravenous and~     oral replacement of the drug would gain an earlier and greater reduction of albuminuria,~     compared with oral use only.~   "
132864|NCT01316055|"~     The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram)~     tablets in healthy adult volunteers and those with mild and moderate renal impairment, and~     examine between group comparisons.~   "
132865|NCT01316042|"~     The primary objective of this study is to determine the safety and efficacy of metformin in~     lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe~     changes in hormones associated with pubertal development including gonadotropins, sex~     steroids, insulin, adipocytokines, and growth factors.~   "
132866|NCT01316029|"~     The purpose of this study is to determine the symptomatic changes after a single session of~     laying-on-of-hands in various settings, and to evaluate optimal conditions for the outcomes.~   "
132867|NCT01316016|"~     The purpose of this study is to determine whether daily intake of a drink containing rose~     hip powder reduces risk markers of type diabetes and cardiovascular disease.~   "
132868|NCT01316003|"~     The aim of this study is to investigate the incidence and possible causes of obscured or~     disrupted cone outer segment tips line at fovea in spectral-domain optical coherence~     tomography images of normal eyes.~   "
132869|NCT01315990|"~     The purpose of this interventional study is to assess the progression free survival (one~     year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal~     prophylaxis.~      Further Objectives:~        1. Development of acneiforme follicular exanthema >= grade 2~        2. Duration until development of acneiforme follicular exanthema >= grade 2~        3. Development of paronychia~        4. Development skin fissure (hand and foot)~        5. Objective remission according RECIST 1.1~        6. Rate of secondary resections of liver metastasis with a curative approach~        7. Assessment of safety and tolerability~        8. Overall survival~        9. Progression free survival~   "
132870|NCT01315977|"~     Aging is associated with increased risk of various diseases, and much attention is given to~     the use of natural products (like herbs) and 'functional food', such as teas, for healthy~     aging.~      The body is continuously exposed to potentially damaging agents (known as free radicals).~     The imbalance between the amount of free radicals and that of antioxidants in the body is~     known as oxidative stress. It is known that Type 2 DM is a state of increased oxidative~     stress, which is thought to lead to many long term complications of Type 2 DM, such as heart~     disease, vision problems and kidney failure. Antioxidant therapy, including increased~     consumption of antioxidant rich foods and beverages such as green tea, has been suggested as~     possibly beneficial in lowering the risk of these complications.~      The purpose of this study is to examine the effects of regular intake of green tea on~     indices of oxidative stress and antioxidant defense within cells, plasma and urine so as to~     investigate if regular intake of green tea can be recommended for health promotion.~   "
132885|NCT01315782|"~     This is an observational study to understand the changes in alveolar dead space in medical~     critically ill patients with severe infection (severe sepsis) requiring mechanical~     ventilation and the possibility to predict multi-organ failure.~      The measurement of alveolar dead space used to require sophisticated equipment and time. New~     ventilators have microprocessors that allow rapid mathematical calculation with minimal~     intervention.~   "
133264|NCT01310686|"~     To obtain a genotypic analysis of patients with chronic exudative age-related macular~     degeneration noted to have subretinal or intraretinal edema despite continuous monthly~     Anti-VEGF therapy.~   "
132871|NCT01315964|"~     Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to~     10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s~     complications (e.g., acute myocardial infarction) in adult human subjects.~      The purpose of the present study is to evaluate among healthy human subjects (N=100) effects~     of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on~     arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries,~     arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®,~     EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the~     end of the 6-month-long study period. Also questionnaires concerning healthy, and life and~     dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done.~      Hypothesis of the study is that a dietary serum cholesterol lowering intervention has~     beneficial influence on the early prognostic markers of premature atherosclerosis.~   "
132872|NCT01315951|"~     The goal of this research is to demonstrate the use of petroleum jelly in prevention of~     nonscalp seborrheic dermatitis exacerbations at the first signs of a flare. In doing so, it~     will decrease the chronic use of topical steroids. The use of petrolatum should have~     favorable outcomes for patients, without the side-effects.~   "
132873|NCT01315938|"~     The purpose of this study is to investigate the clinical efficacy of abatacept on disease~     activity in polymyositis, and dermatomyositis patients.~   "
132874|NCT01315925|"~     SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze~     risk factors for developing an invasive fungal infection in patients with newly diagnosed~     Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those~     related to normal activities of daily life, such as occupation, location and type of~     residence, consume of tobacco, alcohol and others).~   "
132875|NCT01315912|"~     In a prospective interventional study, 44 Clomiphene resistant infertile patients were~     selected from Abolfazl Infertility Clinic of Bushehr University of Medical Sciences.~     Letrozole was given orally in a dose of 2.5mg, 5mg and 7.5mg, respectively. If the patient~     displayed no response, the dosage was increased. The size of follicle, endometrial~     thickness, estradiol, complications and clinical pregnancy rate were evaluated as the final~     outcome.~   "
132876|NCT01315899|"~     Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic~     impairment of blood flow. During an attack of RP which commonly affects the hands and feet~     these arteries contract briefly which limits the blood flow (this is called a vasospasm) and~     deprived of blood the skin turns white then blue. The aim of this study is to prove the~     concept that ORM-12741 can prevent these blood vessel spasms.~   "
132877|NCT01315886|"~     The purpose of this study is to evaluate safety and efficacy when using a novel dose~     conversion strategy to switch from immediate release oral opioids to sublingual (SL)~     fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).~   "
132878|NCT01315873|"~     Patients with myeloma that has either not responded to previous treatment or has returned~     after previous treatment will be given a combination of the drugs bendamustine and~     bortezomib.~      The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4~     of each cycle, with bortezomib being given first, before each dose of bendamustine. Each~     cycle will be 28 days long, so patients will be treated the first week of each cycle and~     then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on~     day 22 of each cycle. Patients will receive the study drugs until their disease progresses~     or they are withdrawn from the study.~      In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes~     to show that the combination of bortezomib and bendamustine will have activity in~     relapsed/refractory myeloma.~   "
132879|NCT01315860|"~     Low back and posterior pelvic pain are common in pregnant females. Previous studies have~     demonstrated disability and it is estimated that all women experience some degree of~     musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant~     females have temporarily disabling symptoms.~      There is demonstrated controversy over the mechanism of low back pain in pregnancy. The~     biomechanical theory implies that the enlarging uterus causes the maternal center of gravity~     to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight~     gain correlated with biomechanical changes. The changes were measured by weight gain in~     segmental regions of the body and in principal moments of inertia from the sit to stand~     movement. Literature does not demonstrate a specific correlation between weight gain and the~     biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three~     measurements may have a correlating effect on the underlying cause of low back pain in~     pregnant women.~      This study aims to determine the correlation between weight gain of pregnant females and the~     biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in~     weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle~     and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry~     Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center~     of gravity.~   "
132880|NCT01315847|"~     The purpose of this study is to determine the receptor occupancy (RO) associated with~     telcagepant (MK-0974) administration based on displacement of [11C]MK-4232 from the CGRP~     receptors in the brain using PET. The study enrolled healthy participants (Part I) and~     migraine patients (Part III). Due to a protocol amendment, study Part II was not conducted.~   "
132881|NCT01315834|"~     The main purpose of this study is to examine the contribution of personality traits to~     marital satisfaction and well -being among couples coping with Coronary Heart Disease (CHD)~     and couples from the general population, and to health promoting behaviors and physical~     recovery among the ill partners.~   "
132882|NCT01315821|"~     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal~     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in~     newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli~     sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces~     boulardii has not been used in the prevention of NEC in very low birth weight infants yet.~     The objective of this study is to evaluate the efficacy of orally administered S boulardii~     in reducing the incidence and severity of NEC in very low birth weight infants.~   "
135993|NCT01274884|"~     Several surgical techniques are used for the treatment of acute acromioclavicular joint~     dislocations. The investigators investigate a new method using arthroscopic repair using the~     Tightrope fixation device.~   "
132886|NCT01315769|"~     This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and~     primiparous women. Subjective evaluation of PFM strength was performed vaginal digital~     palpation (TDP). The objective evaluation of PFM strength was assessed using a portable~     perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th~     and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery~     may cause weakness of PFM.~   "
132887|NCT01315756|"~     It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the~     patients as active players, will improve diabetes self-management reflected by improved~     glycemic control and lipids, self-care behaviours and lifestyle changes such as improved~     dietary habits and increased physical activity, compared with usual care. Following this; it~     is also hypothesized that this will also lead to a reduction in overall risk for diabetes~     complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery~     disease as calculated using the Swedish National Diabetes Register's risk calculator) and in~     the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes~     Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes~     nurse, and with individualized feedback via sms from the diabetes nurse, may have an~     important function as a supplement to the self-help system (FTA). In addition, it is~     hypothesized that the patients' health status and diabetes-related quality of life (HRQL)~     will improve. The results of this study may show that a commonly used tool like the mobile~     phone, and also mobile phone together with health counselling, fitted into the patients'~     daily life, is more effective and cost-effective than standard care.~   "
132888|NCT01315743|"~     The goal of this exploratory pilot study was to develop and test the acceptability and~     feasibility of an innovative alternative high school-based intervention to prevent further~     weight gain and/or promote weight loss among a sample of ethnically and economically diverse~     adolescents.~   "
132889|NCT01315730|"~     The purpose of this research project is to test the effects of exposure of different forms~     of tactile speech feedback on overt stuttering frequency.~   "
132890|NCT01315717|"~     The purpose of this study is to examine and to compare gait characteristics under single-~     and dual-task conditions among healthy subjects together with AD patients at different~     stages of disease (i.e., pre-dementia, mild and moderate dementia stages).~   "
132891|NCT01315704|"~     The purpose of this study is to compare characteristics of gait and balance measured among~     patients with Alzheimer's disease or related disorders separated into 3 groups according to~     the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine~     the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to~     establish a database at Angers University Memory Centre.~   "
132892|NCT01315691|"~     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence~     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in~     CF patients increases with age and by age 18 years approximately 85% of CF patients in the~     US are infected. Liposomal amikacin for inhalation (Arikace™) was developed as a possible~     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.~      The purpose of this double-blind, placebo controlled study is to determine whether Arikace™~     is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic~     Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US,~     Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or~     placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period.~     The subjects will be required to visit the clinic 8 times (including the Screening visit)~     over a period of approximately 3 months. No overnight stays at the clinic will be required.~     At the completion of the TR02-109 protocol, subjects who have consented and meet study~     safety criteria may enroll in the long-term, open-label, multi-cycle extension study of 590~     mg of Arikace™ (under a separate protocol TR02-110).~   "
132893|NCT01315678|"~     A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence~     of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in~     CF patients increases with age and by age 18 years approximately 85% of CF patients in the~     US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible~     treatment for chronic infection due to Pseudomonas aeruginosa in CF patients.~      The purpose of this European Registration study is to determine whether Arikayce™ is~     effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic~     Fibrosis subjects. The effectiveness, safety and tolerability of Arikayce™ will be compared~     to TOBI, an inhalation antibiotic already available for use. The study will enroll~     approximately 300 subjects in clinics in Europe and Canada. Subjects will be required to~     visit the clinic 9 times (including the Screening visit) over a period of approximately 6~     months. No overnight stays at the clinic will be required.~   "
132894|NCT01315665|"~     The purpose of this study to investigate the effect of sulforaphane from macerated broccoli~     sprouts in humans and to evaluate less invasive methods of assessing potential~     anti-inflammatory drugs in CF.~   "
132895|NCT01315652|"~     The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse~     checking the preventive modalities and/or the presence of comorbidities such as infections (~     e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin,~     antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g.~     bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the~     impact of an educational program aimed at permitting rheumatoid arthritis patients to~     auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).~   "
132896|NCT01315639|"~     The aim of this study is to examine the relationship between plasma putative biomarkers for~     Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound,~     truncated, sAPPα) and :~        -  the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into~          Alzheimer's disease (AD),~        -  the Alzheimer's disease progression rate.~   "
132897|NCT01315626|"~     A study of an educational intervention of primary care practice physicians to assist in the~     identification of patients who have Bronchiectasis and to assess the effectiveness of the~     specific didactic educational intervention targeting primary care physicians in the~     recognition of Bronchiectasis.~   "
135994|NCT01274871|"~     Does chest drains contribute to the post thoracotomy pain syndrome~   "
132898|NCT01315613|"~     Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are~     not well known. The IL-1 cytokine family is activated early during acute pancreatitis and~     secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the~     IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88~     which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to~     investigate ST2 pathway in human acute pancreatitis and in murine experimental models of~     acute pancreatitis.~   "
132899|NCT01315587|"~     The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and~     durable effects to the apply traditional rTMS protocols. The aim of this study is to~     investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms~     and remission of cognitive functioning in patients with schizophrenia. In a randomized,~     double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital~     will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20~     sessions. The negative symptoms and cognitive functioning will be assessed before the~     treatment (pre test) during the treatment (session 10), and after the treatment (post~     test).QEEG and LORETA apply before and after rTMS in all subjects.~   "
132900|NCT01315574|"~     The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z)~     and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma~     medications may be associated with decreased tear production and tear film break-up time~     (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids~     and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is~     continuous and blinking maintains the tear film continuity. If you keep your eyes open long~     enough without blinking, the tear film will start breaking up. Your eye will feel~     uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable,~     and breaks up faster. Therefore the tear break up time in patients who have dry eyes is~     shorter.~      In this study, the investigators will be comparing the two previously mentioned FDA-approved~     eye drops Latanoprost and Travoprost. The difference between the two medications is a~     preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost~     does not. The investigators will be comparing the efficacy of each medication in lowering~     IOP as well as trying to track the density of immune cells across the corneal surface by~     taking photos of your eye. The investigators will also be assessing whether either drop~     leads to symptoms of dry eye by comparing results from ocular surface exam tests such as~     TBUT.~   "
132901|NCT01315561|"~     Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is~     exposed to active or passive movement and exercise during acupuncture, as opposed to~     conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in~     the treating pain and severe functional disability in acute LBP patients.~   "
132902|NCT01315548|"~     The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of~     pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound~     (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and~     pancreatic cancer in a prospective multicenter design.~      The study will include patients with focal pancreatic masses evaluated by CEH-EUS and~     EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the~     patients being included based on a suspicion of focal pancreatic masses after transabdominal~     ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis~     will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology~     and minimum 12 months follow-up.~   "
132903|NCT01315535|"~     The literature does not discuss if the fast oral appliance titration (30 days period) in~     Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in~     such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important~     side effects observed in OSAS treatment with oral appliance. Since the effectiveness of~     mandibular exercises in the control of TMD pain has already been verified, it may play a~     fundamental role in the support of the fast oral appliance titration.~   "
132904|NCT01315522|"~     Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard~     intervention for the relief of obstructive jaundice in patients with unresectable malignant~     biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable~     metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as~     SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a~     limited number of reports on the management of occluded SEMS with various results. The aim~     of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in~     subsequent ERBD after the occlusion of initial SEMSs.~   "
132905|NCT01315509|"~     The investigators aim to assess the dental status of psychiatric patients suffering from~     severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).~   "
132906|NCT01315496|"~     This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human~     Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.~   "
132907|NCT01315483|"~     In the United States, overweight (BMI > 25 but < 30 Kg/m2) and obesity (BMI > 30Kg/m2) are~     increasing at epidemic rates. A significant association exists between being overweight or~     obese and breast cancer recurrence and survival. However, evidence continues to accumulate~     indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI,~     18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in~     breast cancer associated mortality. Despite this, there is a lack of randomized controlled~     trials exploring this association and how the process of fat loss or being successful in~     actually reaching a healthy weight for height differentially affects biomarkers for cancer~     recurrence.~      Many dietary approaches for weight loss are currently available to the public, and each~     purports to offer advantages. However, there is little scientific evidence to indicate how~     these dietary approaches, some of which vary markedly in the foods that they limit or~     exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the~     critical factor in relation to weight and breast cancer is simply weight loss (negative~     energy balance), irrespective of the manner in which it is achieved, or if certain dietary~     approaches affect breast cancer risk biomarkers more favorably than others. Published data~     from our laboratory suggest that dietary pattern does matter, and therefore the goal of this~     study is to investigate the effects of two popular weight loss dietary approaches that~     differ in the extent to which they limit carbohydrate or fat consumption (with effects on~     dietary glycemic load) compared to a usual care group on prognostic markers for cancer~     recurrence in postmenopausal breast cancer survivors. The investigators hypothesize that in~     addition to the anticipated effects of fat loss on circulating levels of bioavailable sex~     steroid hormones, that the effects of excess fat on breast cancer prognosis can be~     attributed to three interrelated metabolic processes that affect cancer progression: altered~     glucose metabolism, chronic inflammation and excessive cellular oxidation.~   "
135995|NCT01274858|"~     The study will investigate topography of sensory changes late after lung cancer surgery~   "
132910|NCT01315444|"~     Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of~     the Western population. These millions of patients are treated continuously with PPI for~     different periods, many for many years. Recently, rebound acid hypersecretion was recognized~     as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to~     daily PPI therapy causes increased acid-secretory capacity that appears when the drug is~     stopped. The transient increase in blood and urinary pH following gastric secretion has been~     termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme~     carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal~     acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral~     chloride bicarbonate exchanger. The investigators have shown in several studies that this~     phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal~     increased base excess maximally after 45 minutes and these changes parallel peak acid output~     measured in gastric aspirate. The investigators hypothesize that gradual step down cessation~     of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI~     cessation the investigators may prove this hypothesis.~   "
132911|NCT01315431|"~     This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in~     combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through~     14) in a 21-day cycle.~   "
132912|NCT01315418|"~     This multicentric, randomized, double-blind and controlled study aims to examine the effect~     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001~     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common~     infectious diseases (cumulated number of infections during the intervention period: primary~     criteria), and on the Quality of Life in adults submitted to multi-stressor situation.~     Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for~     7-weeks.~   "
132913|NCT01315405|"~     After few years of evolution, patients with Parkinson's disease may develop apathy, with~     different degrees of severity. Apathy is characterized by a loss of interest for the others~     and for activities. The lack of social interactions in these patients may be due to an~     impairment in decoding emotional facial expression. Indeed, facial expression recognition,~     which is necessary to understand other's emotional state, requires a subclinical facial~     mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.~      This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's~     disease )patients with emotional facial expression (EFE) recognition impairment, compared to~     healthy control subjects. We also want to know if this facial mimicry disorder is primary~     (subtended by facial mobility impairment, that is to say amimia) or secondary (related to~     the mirror neuron systems that allows us to activate similar neural networks when observing~     and feeling a specific emotion)~   "
132914|NCT01315392|"~     Delayed wound closure is considered by many to be the standard of care for the treatment of~     an open fracture. This study was conducted to determine the feasibility of a large~     multi-center prospective randomized clinical trial and collect the pilot data needed to~     compete for the funding for such a trial. The study was designed to compare immediate and~     delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes~     were the infection rates and fracture related complications in patients treated with~     immediate or delayed wound closure strategies.~   "
132915|NCT01315379|"~     The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is~     effective in the treatment of post-traumatic stress symptoms in children and adolescents~     with mild traumatic brain injury (m-TBI) due to motor vehicle accident.~   "
132916|NCT01315366|"~     The optimal dose of vitamin D needed to optimize beneficial effects on musculoskeletal~     outcomes remains to be defined. Equally unclear is the impact of vitamin D on fuel~     metabolism and insulin sensitivity in human subjects. Thus, the overall objective of this~     proposal is to test the hypothesis that in ambulatory overweight elderly individuals,~     vitamin D administration at doses higher than currently recommended will:~        1. Have a salutary effect on parameters of glucose and fuel metabolism. It will thus~          decrease indices of insulin resistance, improve lipid profile, and decrease markers of~          cardiovascular disease including adipokines, inflammatory cytokines, and markers of~          cell adhesion.~        2. Have a superior effect on indices of mineral and musculoskeletal metabolism, including~          bone remodeling markers, lean mass, and bone mineral density.~      We will investigate whether this effect is modulated by entry status of vitaminD and PTH as~     detailed below~   "
132917|NCT01315353|"~     Women sometimes develop cancer in an area called the cervix, which is the opening to the~     uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women~     who do not have HIV. Nearly all of these cancers are caused by another virus, called human~     papilloma virus (or HPV). Other times, the cause of this cancer is not known.~      The investigators are looking for a better way to prevent cervical cancer. This study is~     comparing two different methods to prevent cancer of the cervix in women who have HIV. This~     study will also see if these methods are safe and tolerable in women who have HIV.~   "
132918|NCT01315340|"~     Ocular rigidity characterizes the relationship between pressure and volume changes in the~     human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of~     the resistance of the conventional outflow pathway and represents a parameter that is of~     interest in glaucoma.~      Difficulties in the measurement of ocular rigidity in the living human eye have limited our~     knowledge on this parameter. However, ocular biomechanics have been implicated in the~     pathogenesis of this disease. The aim of this study is to characterize the pressure volume~     relation and quantify ocular rigidity and outflow facility in glaucomatous and normal eyes.~     For this purpose, the investigators have recently developed a manometric method for the~     measurement of ocular rigidity and outflow facility.~   "
132919|NCT01315327|"~     This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the~     treatment of Tourette's Disorder.~   "
132920|NCT01315314|"~     The purpose of this study is to evaluate the effects of neutral pH and low glucose~     degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic~     inflammation and endothelial dysfunction markers in incident PD patients.~   "
133287|NCT01310387|"~     This study is:~        -  A single-center, randomized, prospective controlled trial.~        -  To prove superiority of active pain management group compared to control group by the~          percent of pain intensity difference of outpatients with lung cancer pain.~        -  204 patients will be recruited.~   "
132921|NCT01315301|"~     Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB~     co-infected patients who recently started treatment for Tuberculosis by comparing immediate~     versus deferred initiation of HAART.~      The study will address the following questions;~        -  Is it possible to reduce mortality rate and increase survival by early initiation of~          HAART during TB treatment with out compromising for adverse drug reaction, toxicity and~          immune reconstitution syndrome?~        -  What is the risk/ benefit ratio between immediate versus deferred initiation of HAART~          during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?~        -  When is the most appropriate time to start HAART during TB treatment?~   "
132922|NCT01315288|"~     The purpose of this study is to determine patient variables, physician presenter variables,~     and information variables that might affect clinical decision making in asymptomatic carotid~     stenosis. The hypothesis is that information variables are the most significant determinant~     of clinical decision making.~   "
132923|NCT01315275|"~     The purpose of this study is to evaluate the proportion of patients with a 10 letters gain~     on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.~   "
132924|NCT01315262|"~     Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine~     monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the~     treatment of erectile dysfunction (ED). Objectives:~        -  To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at~          bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following~          radical prostatectomy.~        -  To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily~          after radical prostatectomy.~   "
132925|NCT01315249|"~     The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol~     and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a~     26-week period in patients with moderate to severe COPD.~   "
132926|NCT01315236|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of~     daily dosing of 590 mg of LAI versus placebo in patients with recalcitrant NTM lung disease.~   "
132927|NCT01315223|"~     Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure~     (AHF) several times a year. Currently, we have no method for prediction of future~     developments of AHF. In our center we have investigated the monitoring of lung impedence as~     a predictor for future deterioration. It was found that a decrease in lung impedence of more~     than 15% from normal value predicts AHF development with sensitivity of 98%. In this study~     we try to prove the hypothesis that preventive treatment according to lung impedence value~     may prevent future hospitalizations for AHF and improve clinical outcome.~      Patients recruited by year:~      2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5~   "
132928|NCT01315210|"~     To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of~     fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind,~     placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo~     administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who~     are experiencing fatigue associated with a diagnosis of fibromyalgia.~   "
132929|NCT01315197|"~     Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage~     for lower back pain occupational as well as to assess the influence of technique in~     performing work activities and life in the team nursing.~   "
132930|NCT01315184|"~     The purpose of this study is to evaluate the whether an automated telephone-based system is~     useful and helpful for opioid dependent patients receiving buprenorphine in primary care.~     The Recovery Line support system is a Therapeutic Interactive Voice Response system based on~     cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of~     modules presenting the basic principles and strategies of CBT. Each module includes learning~     sections and activities sections to provide direct guidance in using skills. The Recovery~     Line support system is interactive and also includes a questionnaire to help patients~     identify problems and recommend modules for use, as well as an inspiration section, an~     introduction, and an immediate assistance menu. Following development of an initial system~     the current trial will recruit 40 patients receiving buprenorphine maintenance from a~     physician provider in the local community. Patients will be randomly (flip of a coin) to~     receive the Recover Line Support system or to treatment as usual with their physician.~     Patients assigned to TIVR will be trained on the system and provided 24-hr access to the~     TIVR system for a four week period. Primary outcome variables will be how long patients~     remain in treatment, self-reported abstinence from opioids and other drugs, and abstinence~     as measured by weekly drug screens. It is expected that patients assigned to TIVR will~     better treatment outcomes than patients assigned to TAU.~   "
132931|NCT01315171|"~     Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia).~     Hypoglycemia can be associated with confusion and disorientation as well as other symptoms~     such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as~     a fuel in the brain during low blood sugar levels and therefore may prevent or reduce some~     of the confusion and disorientation seen during hypoglycemia. We would like to determine if~     a diet supplemented with medium chain triglycerides can improve cognitive function during~     hypoglycemia, diabetes control and also look at brain activity.~   "
132932|NCT01315158|"~     This will be a randomized controlled trial that compares the rates of sedation related~     complications in high risk patients (ASA greater or equal to 3, BMI greater or equal to 30,~     those at risk for OSA) undergoing advanced endoscopy procedures with propofol alone compared~     to propofol in combination with benzodiazepines and opioids.~   "
132933|NCT01315145|"~     This is a multi-center, prospective, observational clinical study to compare patient~     outcomes following treatment with either the mild® procedure or epidural steroid injection~     in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic~     claudication.~   "
132934|NCT01315132|"~     This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in~     matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to~     increase overall survival.~   "
132935|NCT01315119|"~     The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in~     reducing post-operative complications associated with low breast skin blood flow after~     breast reconstruction using implants.~   "
132938|NCT01315080|"~     The investigators recently proposed a new hypothesis on the pathogenesis of mammillary~     fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may~     relevantly contribute to the development of MF. The investigators believe that the~     pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical~     entities manifest themselves as a chronic, suppurative and recurrent inflammatory process.~     This new proposal has led to the present suggestion of a therapeutic alternative for MF.~   "
132939|NCT01315067|"~     Reliable and timely detection of acute rejections in renal transplant patients is important~     to preserve the graft function and to prevent premature graft failure. The current gold~     standard for the rejection diagnosis is a renal biopsy which is usually performed upon an~     unexplained decline in the graft function (determined by serum creatinine or clearance).~     Because of the insensitivity of creatinine determinations and the invasiveness of renal~     biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass~     spectrometry (MS) analysis of urine samples.~      The ability of MS analysis to detect acute rejection has been demonstrated in small studies~     on selected patients but evidence is lacking that this test is efficacious in the routine~     setting of the post-transplant patient care. Based on our previous work that established~     urine peptide sets for acute rejection by MS, a prospective, multicentre diagnostic phase~     III study will be executed.~      The aim of the study is to prove that this test is as equally effective as the allograft~     biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal~     dysfunction. The perspective of this approach is that the test could be used either in place~     of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence~     of rejection. Another perspective is that the MS test (respectively, a simplified test~     system derived from this method) could be used in the regular post-transplant surveillance~     for acute rejection, in place of the relatively insensitive procedure with periodic~     monitoring of the graft function by creatinine determinations.~   "
132940|NCT01315054|"~     Methadone treatment has became one of main actions taken in China to control the spread of~     HIV among drug users. However，the average methadone dose used is relatively low. An~     intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be~     effective in increasing the methadone dose levels prescribed to new patients. The study will~     evaluate the effectiveness of a tailored education program for MMT service providers using~     subsequent methadone dose prescribed to new patients. The effects of methadone dose, with~     and without the inclusion of additional psychosocial services, will then be measured through~     MMT retention and illicit opioid use.~   "
132941|NCT01315041|"~     Hot flushes are common symptoms in women after menopause, and are important causes of~     discomfort and lead to high number of medical consultations. Hormone replacement therapy is~     an effective treatment, however it can bring undesirable consequences and may be~     contraindicated for some women. Options are inhibitors of serotonin or~     serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. None of~     these therapies is widely accepted of effective. Therefore, the search for new therapeutic~     options is highly desirable. Ingestion of malagueta pepper fruits (Capsicum frutescens L.~     var. malagueta) causes sensations similar to those experienced by menopausal women during~     hot flushes. By the principle of homeopathy, the like cures the like, the objectives of~     this study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from~     C. frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is~     effective on hot flushes relief in women after menopause. There will be 2 distinct phases.~     Phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a~     randomized placebo-controlled, double-blind design. Phase 2 is the investigation of the~     medicine's effects on hot flushes of women after menopause, in a randomized~     placebo-controlled, double-blind design. The investigators expect a significant reduction on~     symptoms perception, assessed by internationally validated tools. The study is expected to~     last for 18 months, with 36 patients included in each phase.~   "
132942|NCT01315028|"~     There is a need to develop a better understanding of the early phase of bipolar disorder,~     and to develop and evaluate effective psychosocial interventions that assist people in this~     phase. The purpose of this study is to determine whether or not it is feasible to conduct a~     larger study of the effectiveness of cognitive interpersonal therapy (a psychological~     therapy) with individuals who have experienced their first or second treated episode of~     mania or hypomania (symptoms common in early development of bipolar disorders).~   "
132943|NCT01315015|"~     The purpose of this study is to determine the cost-effectiveness of biennial screening with~     mammography and MRI compared to mammography alone in women aged 50-75 years and who show >~     75% mammographic density.~   "
132944|NCT01315002|"~     The purpose of this study is to test the effects of nicotine on cognition with the following~     schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance~     test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected~     first-degree relatives of schizophrenia patients and healthy controls receive transdermal~     nicotine in a double-blind, placebo-controlled, crossover study.~   "
132945|NCT01314989|"~     Cyproheptadine is currently clinically used as an appetite stimulant for children with~     failure to thrive without underlying organic disease. Otherwise, no randomised control trial~     demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the~     investigators intend to demonstrate on this randomised placebo control cross-over trial. Our~     hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and~     feeding behaviour on 2 to 4 years old children with failure to thrive.~   "
132946|NCT01314976|"~     Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is~     considered a possible cause of infectious gastrointestinal disease in adults and children.~     DF has a particular high prevalence in children, and it is suspected that children present~     more symptoms in infection than adults. However, evidence of causality is lacking, treatment~     regimens are largely untested in controlled trials, and the most commonly used antibiotic~     against DF in Denmark, metronidazole, has never been tested against placebo.~      Main objective: To determine the clinical effect of metronidazole in DF-infected children~     with gastrointestinal complaints, where no other aetiology is known and no other~     gastrointestinal pathogens could be shown.~   "
133315|NCT01310023|"~     SMARTT will estimate the incidence of conditions and diagnoses potentially related to in~     utero exposure to antiretroviral therapy and/or exposure in the first two months of life~     among children born of HIV-infected mothers.~   "
132947|NCT01314963|"~     Lymphoscintigraphy is an accepted and commonly performed procedure used for staging of~     certain cancers, especially melanoma and breast cancer. It involves injecting a small amount~     of radioactivity under the skin in order to identify lymph nodes which should be biopsied~     (i.e., the sentinel node) to determine if cancer has spread. Our objective is to evaluate~     the potential benefit of a new, camera-based technology which allows actual images to be~     obtained intraoperatively in the identification of sentinel nodes.~   "
132948|NCT01314950|"~     The purpose of this study is to conduct a two-year randomized, controlled clinical trial to~     improve functioning among older adults with Alzheimer's disease by comparing a control group~     receiving best practices primary care with an intervention group receiving best practice~     primary care plus a home-based occupational therapy intervention.~   "
132949|NCT01314937|"~     Worldwide, over 2 billion people suffer from worm infections in developing countries. These~     infections are especially damaging to the health of children, resulting in both short-term~     and lifelong disability. Older children with worm infections are more likely to be stunted,~     underweight, vulnerable to other illnesses and perform poorly in school compared to~     non-infected children. Large-scale deworming programs in school-age children are therefore~     recommended by the World Health Organization (WHO). WHO also recommends deworming of~     preschool-age children (as of 12 months of age) in these areas; however, the benefits of~     deworming, especially in the 12-24 month age group, have been inadequately studied. This~     knowledge is urgently needed as studies show that all children have a similar potential for~     healthy growth and development, provided that appropriate nutrition and health interventions~     are given in the critical window of opportunity before the age of two.~      Therefore, the investigators are proposing to undertake a randomized controlled trial to~     determine the effect of deworming program for improving growth and development in children~     between 12 and 24 months of age. Our results will provide solid rigorous evidence on if,~     when, and how often, deworming should be integrated into routine child health care packages~     provided by Ministries of Health in the 130 countries in the world where worm infections are~     endemic.~   "
132950|NCT01314924|"~     We aimed to identify clinical and vascular parameters of treated hypertensive patients who~     present beneficial effects of dark chocolate for one-week period on vascular function.~   "
132951|NCT01314911|"~     People who are infected with the influenza virus may develop respiratory illnesses, such as~     pneumonia, or other life-threatening complications. Currently, there are four antiviral~     medications that are used to treat influenza. This study will examine one of these~     medications, oseltamivir, to examine how it affects the shedding of influenza virus in~     infected people.~   "
132952|NCT01314898|"~     24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid~     activity. The dose-response relationship of the antimineralocorticoid activity of~     PF-03882845 can be established following single oral doses.~   "
132953|NCT01314885|"~     A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it~     has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute~     inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an~     internal control for the study.~   "
132954|NCT01314872|"~     This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily~     urinations more effectively than placebo in participants with overactive bladder (OAB). The~     primary hypothesis of the base study is that administration of vibegron demonstrates a~     dose-related reduction, compared with placebo, in average number of daily micturitions in~     participants with OAB after 8 weeks of treatment.~   "
132955|NCT01314859|"~     This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor.~     The principal aim of this study is to compare the efficacy and safety of Nifedipine~     treatment versus Atosiban treatment over these patients' newborn babies.~   "
132956|NCT01314846|"~     Fertilization and embryo development in vivo occurs in appropriate conditions in the~     mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and~     oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations~     that may affect embryo development and viability in vitro. In Preimplantation Genetic~     Screening program (PGS) the investigators need to culture the embryos until day 5 so the~     requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As~     it has been shown before, embryo culture conditions have the potential to impact biopsied~     embryos and hence PGS success rates.~      Nowadays the coculture system with endometrial cells could be an alternative option to~     improve the blastocyst rates since some publications have indicated that endometrial cells~     may provide trace elements and growth factors that are not present in defined culture media~     and reproduce physiologic conditions. Although the role of coculture in vitro fertilization~     (IVF) has been controversial, a recent meta-analysis has established the potential benefits~     of coculture system.~      The aim of this study was to compare embryologic and clinical outcomes in terms of~     blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC)~     coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS~     program.~   "
132957|NCT01314833|"~     In recent years, the increasing number of breast cancer patients shows the fact breast~     cancer is one of the most common cancers in women in China. However, the mortality rate has~     seen a dramatic decline mainly due to early detection of breast cancer and the use of~     effective multimodel treatment. Recent studies suggest breast cancers are heterogeneous and~     recognized by biological subtypes, which lead to markedly different clinical outcome.~      Adjuvant chemotherapy is widely used in the treatment for primary breast cancer patients.~     Different types of breast cancer cells are sensitive to different types of drugs.There is no~     data to support the information about the adjuvant chemotherapy regimens for different~     subtypes breast cancer patients， especially for Chinese women.~      The investigators hypothesized to confirm the possibility of finding the adjuvant~     chemotherapy aimed to different subtypes of breast cancer.~   "
132958|NCT01314820|"~     The present study investigated whether the presence of fluid in the joint affected peak~     torque and the root mean square (RMS) values of surface electromyography (EMG) in patients~     symptomatic for osteoarthritis (OA).~   "
133316|NCT01310010|"~     Study hypothesis:~      Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+~     ALL in the post SCT setting.~   "
132959|NCT01314807|"~     The aim of this prospective case-control study is to investigate the prevalence, severity~     and incidence of systemic consequences in newly detected patients with mild and moderate~     Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal~     muscle dysfunction and physical inactivity as these factors are, together with smoking,~     potentially modifiable.~   "
132960|NCT01314781|"~     The aim of the present study is to investigate in patients with overactive bladder syndrome~     (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and~     whole body vibration training achieves a better treatment outcome than a treatment with~     solifenacin alone.~   "
132961|NCT01314768|"~     The investigators will perform a cluster randomised controlled study of Brief intervention~     (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to~     perform a structured brief intervention after identifying patients with probable MOH using~     the severity of dependence scale. The control arm will include patients of GPs who have not~     been trained in BI. Patients will be recruited by prior short postal screening of patients~     listed on the GPs patient lists.~      The hypothesis is that BI will lead to improvement of medication-overuse and chronic~     headache as compared to no BI.~      Main outcomes are:~        -  number of medication days per month~        -  number of headache days per month~        -  headache index~   "
132962|NCT01314755|"~     Study Hypothesis: The peri-operative enteral administration of a proprietary~     immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in~     patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).~      Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming~     they fulfill the eligibility criteria, be block randomised into a two-group, double-blind~     randomised controlled trial. One group will receive IMPACT, the other an iso-caloric,~     iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups~     patients will be fed enterally. The feeds will be prepared in identical bottles to~     facilitate blinding. Primary outcome measures include major systemic infection, whilst~     secondary outcome measures include local infection and length of hospital stay. Follow-up~     will be for 30 days postsurgery.~   "
132963|NCT01314742|"~     The goal of this pilot study is to test the hypothesis that mechanically ventilated infants~     receiving Biotene OralBalance® gel for oral care would have a reduced intubation time~     compared to infants receiving oral care placebo. This study is also performed to test the~     feasibility as well the safety of Biotene OralBalance® gel.~   "
132964|NCT01314729|"~     Different types of retainers have been used to assure the stability of orthodontic~     treatment. The aim of this study is clinical and radiographic comparison and evaluation of~     two common types of lingual fixed retainers on the health of periodontium.~      The participants in this study will be examined both clinically and radiographically just~     after the completion of orthodontic treatment and after a 6-month-period.~      The results of the study will be analyzed with Mann-whitney and independent t-test.~   "
132965|NCT01314716|"~     The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and~     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam~     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a~     28-day off-drug period. Following the two blinded courses, all participants received a~     28-day course of open-label AZLI then were followed for an additional 56 days.~   "
132966|NCT01314703|"~     The primary objective of this study is to measure the antimicrobial effectiveness of~     ChloraPrep one-Step.~   "
132967|NCT01314690|"~     The objectives of this study are: 1-To qualify the relationship between the gut microbiota~     and the host nutritional and metabolic status during dietary transition.2-To define the~     impact of nutritional transition on the intestinal microbiota and identify metagenomics~     signatures of nutritional transition.~   "
132968|NCT01314677|"~     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography~     (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in~     patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as~     FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help~     doctors predict a patient's response to treatment and help plan the best treatment~   "
132969|NCT01314664|"~     The purpose of this study is to observe and describe the effectiveness and local~     tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder~     cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.~   "
132970|NCT01314651|"~     The purpose of this study is to test the efficacy of a brief behavioral insomnia~     intervention in reducing headache frequency and severity among patients with chronic~     migraine and insomnia. It is hypothesized that this intervention will produce greater~     changes in headache frequency and severity than will a comparison treatment involving~     non-sleep-specific general lifestyle modifications.~   "
132971|NCT01314638|"~     The purpose of this study is to measure the adherence to Siel bleu balance exercises in~     patients with Alzheimer's disease, while taking into account the disease stages.~   "
132972|NCT01314625|"~     The purpose of this study is to determine whether the orthostatic hypotension reported among~     subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic~     nervous system (ANS).~   "
132973|NCT01314612|"~     Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder~     that develops after an extremely stressful event or events. PTSD is associated with problems~     falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from~     stressful experiences. These symptoms can cause problems in daily life. Behavioral~     treatments that do not involve taking medication have been shown to help improve problems~     related to sleep and nightmares. However, very few of these treatments address both sleep~     problems and nightmares at the same time, even though many people suffer from both problems.~     The purpose of this study is to examine the effectiveness of a combined treatment for sleep~     problems and nightmares in Veterans suffering from combat-related PTSD that is presented in~     a group format. The investigators hypothesize that the completion of this treatment will~     lead to increases in sleep quality and decreases in the frequency and severity of nightmares~     as measured by standard questionnaires.~   "
132974|NCT01314599|"~     Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum~     tolerated dose (MTD) and the recommended dose (RD) of PM01183.~   "
132975|NCT01314586|"~     Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower~     serum cholesterol levels.~      Background: Flaxseed has been studied for various health benefits in humans, including~     prostate health, glucose control, and cardiovascular health. Cholesterol levels and high~     blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has~     had variable effects on serum lipid levels, perhaps a consequence of variations in the~     amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making~     the study of this bioactive compound difficult.~      Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL~     cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.~   "
132976|NCT01314573|"~     The purpose of the study is to examine the effects of different exercise intensity training~     programs upon blood vessel function and circulating blood cells involved in blood vessel~     repair in young women. The long term effects of exercise may be beneficial to cardiovascular~     health and it is important to understand the training methods that are the most beneficial.~     In particular we aim to determine if brief maximal exercise improves the function and~     stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are~     being compared, exercise bouts involving intermittent exercise and exercise completed all at~     once, but at a very high intensity.~   "
132977|NCT01314560|"~     Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a~     phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a~     substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of~     hemorrhagic events was found in a retrospective clinical survey, suggesting platelet~     dysfunction.~      The main objective of the study is to confirm the presence of platelet dysfunction in Lowe~     syndrome and to characterize this abnormality.~   "
132978|NCT01314547|"~     Susceptibility to SPA has been shown to be largely genetically determined. The objective of~     this study was to prospectively investigate the impact of several environmental factors on~     disease activity.~   "
132979|NCT01314534|"~     Create a census for the duration of the search for French patients with SK~        -  determining epidemiological and morphological parameters,~        -  determine the true frequency of clinical symptoms and identify new ones,~        -  identify complications of the disease to improve the care of patients in the hope of a~          better prognosis of the disease and~        -  performing a radiological study by Voxel based morphometry MRI type (N. BODDAERT,~          HOPITAL Necker-Enfants Malades, Paris)~      Perform genetic research to identify the genetic bases of SK using CGH-array (Comparative~     Genomic Hybridization )~   "
132980|NCT01314521|"~     The purpose of this study is to examine clinical characteristics of Korean adolescents with~     depression who have suicidal ideation and behavior. We formulate those hypotheses.~        1. Being bullied in peer relationships, excessive use of internet, excessive~          extra-curricular tutoring, sexual abuse in childhood, physical abuse and emotional~          neglect are risk factors of suicide in adolescents.~        2. Depression of parents and negative child-rearing attitude are risk factors of suicidal~          ideation and behavior in adolescents.~        3. Emotional quotient (EQ) and resilience of adolescent are protective factors of suicide.~   "
132981|NCT01314508|"~     A major consequence of chronic liver disease in childhood is growth failure. This is because~     a chemical essential for growth called growth factor is created in the liver. Lack of~     response to growth hormone in people with chronic liver disease is characterized by high~     levels of growth hormone and low levels of growth factors. This growth hormone resistance is~     reflected in a variety of factors including insulin resistance and low nutritional intake.~     Unfortunately, growth hormone therapy has no effect for children with liver disease. In~     addition, failure of normal growth or malnutrition makes liver disease even worse in~     children, and growth hormone therapy is not likely to reverse this. A lack of proper~     nutrition is associated with hospitalizations and frequent complications. Poor growth is a~     predictor of poor outcomes after liver transplantation. Thus the management of children with~     liver disease remains a challenge. Children who have successful orthotopic liver transplants~     (OLT) show much improvement in some aspects of growth, including skin fold thickness,~     mid-arm circumference, and normalization of growth factor levels. However, some studies have~     recently reported that the growth of 15-20% of children remains poor even after a liver~     transplant. This can be explained by persistent abnormalities in growth factors after~     transplant.~      Growth factor was found to be a good tool for prognosis in patients with chronic liver~     disease. Studies showed that patients with liver cirrhosis and growth factor levels below~     normal values showed lower long-term survival rates compared with patients who had above~     normal values. This suggests that growth factor can be a good predictor of survival and~     early marker of poor liver function. In this case, aggressive feeding may modestly improve~     growth factor levels leading to improved growth but it is unlikely that effects will be~     optimal. The investigators propose that growth factor administration may have a positive~     effect that leads to better growth which is a major predictor of good outcome. To date, no~     reports study the use of growth factor in children with chronic liver disease. This study~     proposes to examine the effect of growth factor therapy in childhood chronic liver disease.~   "
132982|NCT01314495|"~     Will Abatacept reduce priming of the hair follicle specific T cells and thereby reduce hair~     follicle associated infiltration and improve hair growth.~      This is a double blind placebo controlled study to test the safety and efficacy of Abatacept~     in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis.~     Subjects will be randomized 1:1 to the placebo or treatment arm and will receive 6 months of~     treatment with the study medication or placebo, followed by a 6 month observational period.~   "
132983|NCT01314482|"~     In about half the patients who have an open chest surgery there is persistent severe pain in~     the chest. The investigators are examining whether minocycline, a commonly used antibiotic,~     will prevent pain. Minocycline blocks the activity of immune cells which the investigators~     believe are responsible for prolonging the pain.~   "
132984|NCT01314469|"~     The aim of this study is to determine if macular edema is associated with less visual~     function and quality of live in patients with intermediate uveitis~   "
132985|NCT01314456|"~     Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the~     prostate gland under a trans-rectal ultrasound probe guidance.~      Today, the performing physician navigates the needle using a momentary 2D ultrasound image~     (longitudinal and transverse B mode) without any record of the full prostate boundaries or~     previous biopsies' location.~      This study's Objectives are to record the trans-rectal biopsy procedure including the~     initial scan and the needle biopsy location and to modulate a 3D model of the prostate with~     accurate display the locations of the various biopsies taken during the procedure.~   "
133012|NCT01314092|"~     Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into~     myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal~     fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown~     efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the~     investigators would apply autologous adipose stem cells on complex perianal fistula to~     evaluate their efficacy and safety.~   "
132986|NCT01314443|"~     Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the~     leading cause of premature mortality in the US. The detrimental effects of smoking on~     vascular dysfunction are attributed to the effects of smoke itself and the inflammatory~     responses it induces. Smoking cessation restores vascular function by alleviating these~     stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the~     prevailing approach to mitigate tobacco dependence, fails to allow full restoration of~     vascular function. Thus, a critical public health problem exists to understand how NRT~     prevents restoration of vascular function and how these NRT-mediated impairments can be~     overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this~     study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining~     how smoking cessation and g-T restore vascular function. The hypothesis is that smoking~     cessation and dietary g-T supplementation will synergistically restore smoking-induced~     impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and~     that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A~     placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing~     nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T~     administration, vascular function will be evaluated using a non-invasive ultrasound~     technique and an array of antioxidants and biomarkers for vascular inflammation and~     oxidative/nitrosative stress responses will be assessed. Collectively, these studies will~     help identify how vascular function is regulated in individuals undergoing smoking~     cessation, and whether g-T can be used as a strategy to better improve vascular function~     during smoking cessation.~   "
132987|NCT01314417|"~     BACKGROUND:~      Uveitis comprises of a group of diseases associated with inflammation of the eye that can~     lead to vision loss. Some people with uveitis also have macular edema (swelling of the~     retina at the back of the eye). Uveitis and macular edema are treated with medications and~     sometimes surgery, but treatment does not always prevent vision loss. Previous research has~     shown that injections of methotrexate into the eye of people with eye disease other than~     uveitis can help relieve the inflammation, or swelling, that causes macular edema and can~     slow visual loss. However, it has not yet been approved as a treatment for macular edema~     associated with uveitis.~      OBJECTIVES:~      To evaluate the safety and effectiveness of methotrexate injections as a treatment for~     macular edema associated with uveitis.~      ELIGIBILITY:~      Individuals at least 18 years of age who have been diagnosed with uveitis and macular edema~     in at least one eye.~      DESIGN:~        -  This study requires at least nine visits to the National Eye Institute study clinic~          over a period of 6 months (24 weeks).~        -  Participants will be screened with a physical and ophthalmic examination, medical~          history, blood and urine tests, and additional eye and other tests as needed.~        -  Participants will receive a methotrexate injection in a selected treatment eye. After~          the injection, participants will receive antibiotic eye drops to place in the eye three~          times a day for the 3 days following the injection, leucovorin (folic acid) drops to~          place in the eye four times a day for 1 week following the injection, and a dose of~          folic acid to be taken by mouth the day after the injection.~        -  Participants who tolerate the initial injection may continue to receive injections in~          their study eye every month for 6 months. After 6 months, participants who show~          improvement from the injections may be evaluated to receive additional injections every~          4 to 8 weeks until researchers end the study.~   "
132988|NCT01314404|"~     The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA Vaccine Foundation or~     GAIA VF) proposes to carry out a Knowledge, Attitudes, and Practices (KAP) study in~     conjunction with a Willingness To Participate (WTP) evaluation to establish the prevalence~     of cervical dysplasia, to and perform Human Papillomavirus (HPV) subtyping studies in Bamako~     and in Sikoro-Mekin, a village within the perimeter of Bamako, the capital of Mali, West~     Africa. Working with experienced collaborators, we propose to carry out an HPV prevalence~     study (among women diagnosed with cervical cancer at Hôpital Touré), coupled with a study of~     Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV~     vaccine study among individuals living in Sikoro-Mekin. These studies will lay the~     groundwork for a phase IV study of Gardasil® at the same site, which would be an important~     step forward for West Africa.~   "
132989|NCT01314391|"~     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~      PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from~     patients with Wilms tumor.~   "
132990|NCT01314378|"~     Dependence on tobacco derived nicotine is a major public health problem. Substance users who~     complete training in mindfulness subjectively report increased patience and improved motor~     control over their impulses. Yet, no studies have tested this perceived benefit with~     behavioral measures of impulse control. The investigators are conducting a randomized~     controlled clinical trial, which compares Cognitive-Behavioral Therapy and Mindfulness~     Training for tobacco smokers, using behavioral measures to investigate the effects of~     mindfulness training on impulsivity and inhibitory control.~   "
132991|NCT01314365|"~     The purpose of the protocol is to determine typical patient response to Dysport in the~     treatment of adult cervical dystonia (CD).~   "
132992|NCT01314352|"~     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's~     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed~     conditions.~   "
132993|NCT01314339|"~     The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's~     Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting~     conditions.~   "
132994|NCT01314326|"~     The specific aims of the clinical studies are to:~        1. Predict the development of glaucomatous visual field (VF) abnormality in glaucoma~          suspects and pre-perimetric glaucoma patients based on anatomic abnormalities detected~          by advanced imaging.~        2. Predict the development of glaucomatous VF abnormality in glaucoma suspects and~          pre-perimetric glaucoma patients based on anatomic changes detected between successive~          advanced imaging tests.~        3. Determine the sensitivity and specificity of glaucoma diagnosis based on advanced~          imaging tests.~   "
132995|NCT01314313|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN~     XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are~     intended for use in patients with symptomatic, calcific, severe aortic stenosis.~   "
132996|NCT01314300|"~     Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic~     zoster adult pains. This treatment is recommended in first intention in adult neuropathic~     pains with allodynia.~      The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster~     (VERSATIS® 5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises~     pains.~   "
133013|NCT01314079|"~     This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of~     Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical~     trial.~   "
133014|NCT01314066|"~     This study aims to test the effectiveness of a single intravenous (IV, through the vein)~     dose of the study drug, bevacizumab (Avastin), in preventing/reducing the development of~     Acute Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high~     risk for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung~     function impairment. The condition the patient has,severe sepsis, is a medical condition~     associated with an infection characterized as an immune system inflammatory response~     throughout your whole body that can lead to organ dysfunction, low blood pressure or~     insufficient blood flow to one or more of your organs.~   "
132997|NCT01314287|"~     General anaesthesia causes small areas of lung to collapse (referred to as atelectasis) and~     many strategies are used to prevent or reverse this, but these strategies only temporarily~     improve lung function and do not persist into the post anaesthesia care unit (PACU) where~     atelectasis may still be present. One possible explanation for this is that coughing~     occurring at the end of the anaesthesic may cause atelectasis to occur. Over 70% of patients~     cough when their breathing tube is removed as they emerge from the anaesthetic, and our~     hypothesis is that the presence of the breathing tube prevents a normal cough from occurring~     and may worsen atelectasis. This study will use alveolar-arterial oxygen difference~     (AaDO2)as a measure of how well the lungs are oxygenating the blood. This will be measured~     30 minutes before the end of the anaesthetic as a control measure of the patient's lung~     function, and again 60 minutes after the patient has woken up, and the change compared with~     the amount of coughing observed as the patient emerges from the anaesthetic.~   "
132998|NCT01314274|"~     In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in~     patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser~     therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal~     bevacizumab compared to placebo in a randomized double blind trial setting.~   "
132999|NCT01314261|"~     The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid~     virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in~     combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone~     (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected~     participants.~   "
133000|NCT01314248|"~     The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway~     maintenance during routine anesthesia and as a conduit for tracheal intubation for patients~     with a difficult airway. The investigators goal for this study is to compare the performance~     of the ILA with the current standard of care the standard LMA during routine anesthesia.~   "
133001|NCT01314235|"~     Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but~     also in many other tissues. It is part of balanced anesthesia in general anesthesiology as~     well as a sedastive agent in intensive care units, but also serves as a third-line agent in~     many psychiatric diseases including ADHD, schizophrenia and PTSD.~      The investigators want to show whether clonidin has an procoagulatoric effect on~     thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel.~     The investigators will use a flowcytometric assay to determine activation of thrombozytes~     when they come into contact with clonidine in vitro as well as Multiplate analyses to~     determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced~     aggregation or arachidonic acid-induced aggregation of thrombozytes.~   "
133002|NCT01314222|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared~     to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).~   "
133003|NCT01314209|"~     The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous~     renal replacement therapy on critically ill patients.~   "
133004|NCT01314196|"~     The aim of this study was to evaluate the influence of progressive resistance training of~     the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome~     (SIS).~      Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved~     by the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS,~     evaluated at the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We~     analyzed the pain at rest (VAS), range of shoulder movement, strength, function by The~     Disabilities of Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36)~     and Western Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and~     analgesics in the presence of pain exacerbated, every eight hours. Study groups will perform~     therapeutic exercises for the shoulder and scapula stabilizers. In the experimental group~     associate progressive resistance training of the biceps.~   "
133005|NCT01314183|"~     The overall aim of the project is to examine the clinical and cost-effectiveness of~     utilizing booster sessions(periodic face-to-face follow-up appointments that take place~     several weeks or months following discharge from the supervised therapy program designed to~     review the patient's current rehabilitation program, troubleshoot any problems with the~     program, and make recommendations for program progression or modification) in the delivery~     of exercise therapy, and supplementing exercise therapy with manual therapy~     techniques(manually applied treatment techniques such as joint mobilization/manipulation,~     manual traction, soft tissue manipulations, passive stretching and range of motion). The~     investigators will do this in a randomized, multi-center, clinical trial. The investigators~     hypothesize that adding manual therapy techniques will be more clinically effective than~     exercise alone and that using booster sessions will maintain longer term clinical effects~     and be more cost-effective than not using booster sessions.~   "
133006|NCT01314170|"~     Study clinical multicenter, phase III, open-label, prospective character to evaluate the~     efficacy and safety Susanna Implant in patients with refractory glaucoma.~   "
133007|NCT01314157|"~     Isostretching is effective in treating chronic back pain to improve pain, quality of life~     and functional capacity.~   "
133008|NCT01314144|"~     Axillary clearance forms part of the surgical armamentarium for the treatment of breast~     cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed~     for the decreased use of axillary clearance, it remains a frequently performed operation.~     Axillary clearance is associated with moderate postoperative pain.~      We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide~     superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing~     axillary lymph node clearance surgery.~   "
133009|NCT01314131|"~     The purpose is to evaluate patients' interests (patients in nursing home). Moreover the~     study aims to evaluate whether an activity for which the patient is interested in, allows a~     better involvement and stimulation.~   "
133010|NCT01314118|"~     The purpose of this study is to show that abiraterone acetate plus prednisone added to the~     current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific~     antigen (PSA) and prolongs the time until it is evident that the cancer has grown.~     Additionally, safety information about abiraterone acetate in combination with prednisone~     will be collected. This will include looking at what side effects occur, how often they~     occur, and for how long they last.~   "
133015|NCT01314053|"~     Daptomycin was approved since 2005 in Taiwan and have been studied and published in west~     countries. After review the published papers, the few data were described in the Asian~     countries or Taiwan. The objectives of this study are to evaluate the efficacy and safety of~     daptomycin for the treatment of Gram-positive infections under actual conditions of use, and~     to understand other information concerned with daptomycin prescription. This study~     represents an opportunity for acquiring real world data on daptomycin usage, and may provide~     physicians in Taiwan with the information of characteristic of the patients receiving~     daptomycin and to evaluate outcomes. It also provides a means to identify safety signals~     that emerge with clinical usage.~   "
133016|NCT01314040|"~     Results from observational studies suggest a small beneficial association between protein~     and blood pressure that may be mainly attributable to the intake of protein from plant~     sources. In epidemiological studies biomarkers of dietary intake are useful to estimate~     intake more reliably. Dietary studies using biomarkers of protein intake generally show~     stronger associations with health outcomes. However, data on biomarkers for specific types~     of protein (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of~     this study is to identify new biomarkers for the intake of protein from meat, dairy and~     grain. In addition the secondary purpose is to investigate whether intake of protein from~     these sources influences kidney filtration rate and urinary acid excretion differentially.~   "
133017|NCT01314027|"~     The outcome of patients with resected pancreatic cancer has significantly been improved by~     adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant~     chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be~     safe and effective and can be applied to all patients. This study should test neoadjuvant~     chemotherapy in a randomized manner.~      Patients with resectable cytologically proven adenocarinoma of the pancreatic head are~     randomized to arm A or B.~      Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with~     gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant~     gemcitabine for six months.~      Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in~     arm A.~      The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined~     by computed tomography in a defined protocol.~        -  Trial with medicinal product~   "
133018|NCT01314014|"~     The purpose of this study is to determine whether Amplimexon (imexon for injection) is~     effective in the treatment of indolent and aggressive lymphomas that have progressed after~     treatment with standard therapies.~   "
133019|NCT01314001|"~     The purpose of this research program is to understand how a biomarker called the nicotine~     metabolite ratio (also referred to as NMR) may influence a smoker's ability to quit~     smoking.~   "
133020|NCT01313988|"~     Plant sterols and fish fatty acids are known to affect the blood lipid profile. This~     randomized, double-blind, placebo-controlled, parallel efficacy study is designed to~     investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose~     of plant sterols and different doses of fish fatty acids when combined in a spread format.~   "
133021|NCT01313975|"~     During the course of their acute illness patients with subarachnoid hemorrhage and severe~     traumatic brain injury often develop disturbances in their fluid balance and electrolyte~     homeostasis. These shifts are associated with worse outcome and increased morbidity.~      The aim of this observational study is to systematically analyze the incidence,~     characteristics, potential diagnostic markers and predisposing factors of such disturbances.~     The investigators hypothesize that many disturbances cannot be classified with a standard~     diagnostic approach and that variable fluid management contributes to their pathophysiology.~      Patients will be closely monitored clinically and the exact fluid and electrolyte balances~     will be recorded. Treatment decisions are within the bedside physicians responsibility.~     Baseline fluid management is standardised. No interventions are planned. The observation~     period equal the duration of ICU stay.~   "
133022|NCT01313962|"~     The purpose of this study is to evaluate the safety and pharmacokinetic profile of~     flufirvitide-3 nasal spray in healthy subjects.~   "
133023|NCT01313949|"~     The investigators hypothesize that a training course to people with diabetes on peer support~     and empowerment will improve their glycemic parameters, knowledge on diabetes and level of~     self efficacy. This group of trained patients (peer leaders) should be competent to teach~     and help other patients with diabetes through peer support and empowerment on better self~     management of their diabetes.~   "
133024|NCT01313936|"~     This is a pilot study to determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are~     tolerable when given with irinotecan/vincristine on a one week schedule to children and~     young adults with high-risk refractory/relapsed neuroblastoma.~   "
133025|NCT01313923|"~     The purpose of this research is to study alternative treatments for the skin disease~     pemphigus (a rare autoimmune blistering disorder of the skin) by using sirolimus, an~     immunosuppressive drug. Immunosuppressive drugs inhibit or prevent the activity of the~     immune system and are commonly used to treat autoimmune diseases, inflammatory diseases, and~     organ transplantation rejection.~   "
133026|NCT01313910|"~     The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel~     movements and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms.~     The study will also examine the effect of ImmunoLin® on the bacteria in the gut and the~     immune system in gut tissue as well as in the blood.~   "
133027|NCT01313897|"~     The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell~     therapy in research participants with relapsed high risk MM [defined as gene expression~     profile (GEP) 70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH~     ≥ 360U/L] by establishing the (near) complete response rate. Response rate will be compared~     to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with~     high-risk MM defined as above). Disease-free survival and overall survival will be captured~     but are not primary or secondary endpoints.~   "
133028|NCT01313884|"~     The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care~     chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature~     we have designed this trial to improve the outcome of patients with metastatic Ewings~     sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.~   "
133029|NCT01313871|"~     The study will assess the disease severity and treatment patterns of rheumatoid arthritis in~     Eastern European, Middle Eastern, and North African countries.~   "
133030|NCT01313858|"~     This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid~     arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to~     evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice~     conditions as assessed by the incidence and type of (serious) adverse events and changes in~     clinical status of participants as assessed by clinical parameters.~   "
133031|NCT01313845|"~     A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait~     freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's~     disease.~        -  administration of IV amantadine or normal saline for 5 days, 2 times a day while~          keeping current oral anti-parkinsonian medications unchanged~        -  follow-up after administration of IV amantadine for 4 weeks~        -  allocation ratio of amantadine:normal saline is 2:1~   "
133032|NCT01313832|"~     Intraoperative myocardial and pulmonary protection is important for better outcome after~     cardiac surgery. Ischemic preconditioning is one of organ protective strategies against~     ischemia-reperfusion injury by applying brief ischemia to the target organ before a~     subsequent critical ischemia, and its effect has been confirmed. However, its clinical~     application is not easy because ischemic insult may aggravate the function of vulnerable~     organ.~      On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by~     applying ischemia to other less vulnerable organ such as skeletal muscle before critical~     ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in~     adults and children. However, Little is known about the effect of remote ischemic~     precondition on the pediatric myocardium to ischemia and reperfusion injury. The effect of~     RIPC on the children remains to be further evaluated because the degree of~     ischemia-reperfusion injury is different according to age, cardiac pathology and cyanosis.~     In addition, the previous report on children dealt with a diverse range of congenital heart~     defects with a wide age range. The purpose of this study was to evaluate the effect of RIPC~     on myocardial and pulmonary protection in infants with pulmonary hypertension who need~     repair of simple ventricular septal defect.~   "
133033|NCT01313819|"~     Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of~     gait(FOG)in patients with Parkinson`s disease~   "
133034|NCT01313806|"~     To determine if low level magnetic fields can help to improve memory in patients diagnosed~     with Alzheimer's disease.~   "
133035|NCT01313793|"~     The study will determine if bioequivalence can be claimed between the proposed~     commericializable formulation and the current clinical formulation. Specifically, if the 90%~     confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration~     (CMax) are within the 80%-125% guidance limits.~   "
133036|NCT01313780|"~     Objectives:~      To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain~     intensity~        1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24~          hours obtained each evening) within 4 weeks~        2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and~          frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need~          of laxative use and Adverse events~   "
133037|NCT01313767|"~     This study is a randomized, double blind, multi-center, active drug controlled, phase III~     clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment~     of post stroke upper limb(wrist, finger, thumb) spasticity~      Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single~     treatment of intramuscular Investigational product up to 360U. The subjects will be observed~     every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth~     Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or~     caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change~     from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth~     Scale. Safety parameters will also be measured including adverse events, vital signs and~     clinical laboratory tests (haematology, serum chemistry and urinanalysis).~   "
133038|NCT01313754|"~     The purpose of this study is to compare different skin closure materials for the~     transobturator suburethral sling procedure. Currently the investigators are using monocryl~     suture material as the standard for skin closure. This material has anecdotally show to be~     very irritating to patients who have had this type of surgery. Our study will compare the~     monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate)~     skin glue. The investigators believe that vicryl suture material will be superior in comfort~     when compared to monocryl and dermabond for this type of procedure.~   "
133039|NCT01313741|"~     Two hundred patients will be analyzed both clinically (via validated outcomes measures) and~     radiographically (via 2 sets of standard radiographs) to determine the survival and degree~     of bone in growth of a novel all polyethelene glenoid component used in a standard FDA~     approved shoulder arthroplasty system.~   "
133040|NCT01313728|"~     This study is to see if there's any difference in the amount of facial irritation when two~     acne products are used together on one side of the face, compared to one acne treatment~     product used alone on the other side of the face. All people participating in this trial~     will be required to return to the same study center every weekday for two weeks for the~     investigator to check for irritation on the face and to have the products applied - on~     weekends they will have to put them on at home. If one side of the face is more irritated~     than the other side, a picture will be taken as well.~   "
133041|NCT01313715|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children~     caused by viruses that belong to the enterovirus genus of the picornavirus family. Although~     most HFMD cases do not result in serious complications, outbreaks of HFMD caused by~     enterovirus 71 (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused~     by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China,~     this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from~     13 to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences~     for the EV71 vaccine immunogenicity and the probable immunizing dose.~   "
133042|NCT01313702|"~     The purpose of this study is to determine whether a polipill improved the compliance with~     treatment compared to usual care that use two or more drugs,in patients at high~     cardiovascular risk or previous cardiovascular disease.~   "
133043|NCT01313689|"~     The purpose of this study is to confirm the clinical benefit observed in the pivotal~     registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP)~     required that a randomized study be conducted in CLL patients with bulky~     fludarabine-refractory disease as a specific obligation for grant of conditional approval~     for ARZERRA™ in the European Union (EU). This study will compare ofatumumab with the~     physicians' choice of therapy.~   "
133044|NCT01313676|"~     The purpose of this study is to determine if fluticasone furoate/vilanterol improves~     survival in patients with chronic obstructive pulmonary disease with a history of or~     increased risk of heart disease.~   "
133045|NCT01313663|"~     This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and~     IVB subjects per the International Association for the Study of Lung Cancer (IASLC) 2009~     Lung cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to~     pemetrexed in the maintenance setting. Subjects should have completed 4-6 cycles of~     induction therapy with carboplatin + pemetrexed or cisplatin + pemetrexed and have had~     Stable Disease (SD), Partial Response (PR) or Complete Response (CR) as the best response to~     be enrolled into the study. The primary objective is to estimate the hazard ratio of~     progression free survival (PFS) in advanced NSCLC subjects given maintenance therapy of~     pazopanib (Arm A) relative to pemetrexed (Arm B). The secondary objectives are: overall~     survival, response rates, safety and tolerability. A total of approximately 200 subjects~     will be enrolled and randomized in a 1:1 ratio. Safety and efficacy assessments will be~     regularly performed on all subjects.~   "
133046|NCT01313650|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation~     Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when~     administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in~     subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will~     complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a~     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone~     contact for adverse event assessment will be conducted approximately one week after the last~     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in~     the study will be approximately 27 weeks. A subset of subjects at selected sites will also~     perform 24-hour serial spirometry and Holter monitoring during the study and provide serial~     blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population~     pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of~     efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169.~     Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory~     tests, and 24 hour Holter monitoring (subset only).~   "
133047|NCT01313637|"~     This is a phase III multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation~     Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when~     administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in~     subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will~     complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a~     24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone~     contact for adverse event assessment will be conducted approximately one week after the last~     study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in~     the study will be approximately 27 weeks. A subset of subjects at selected sites will also~     perform 24-hour serial spirometry and Holter monitoring during the study and provide serial~     blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population~     pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of~     efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169.~     Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory~     tests, and 24 hour Holter monitoring (subset only).~   "
133048|NCT01313624|"~     The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and~     gram-negative airway infection. Participants received two 28-day courses of either Aztreonam~     for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a~     28-day off-drug period. Following the two blinded courses, all participants received a~     28-day course of open-label AZLI then were followed for an additional 56 days.~   "
133049|NCT01313611|"~     The objective of this study is to evaluate the complete response rate after a short~     induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60~     years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI~     score and without high tumor burden.~      This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction~     schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8,~     Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30~     Maintenance schedule: 12 infusions of rituximab, each 8 weeks~   "
133050|NCT01313598|"~     The purpose of the study is to determine the safety and tolerability of GLPG0187~     administered through continuous intravenous infusion and to explore its preliminary clinical~     efficacy in patients with solid tumors.~   "
133051|NCT01313585|"~     This study will compare the absolute and relative effectiveness of asthma management in~     patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) -~     beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn)~     reliever medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e.~     Easi-breathe® [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI~     salbutamol).~   "
133052|NCT01313572|"~     The purpose of this study is to see whether apadenoson is as effective as adenosine when~     used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect~     defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study~     will also look at whether apadenoson is better tolerated than adenosine when used in~     SPECT-MPI.~   "
133084|NCT01312545|"~     This study wants to compare between two types of implants in enucleation. Both of them are~     made from porous polyethylene but have different fabricating techniques. The investigators~     chose an exposure rate as a main outcome because the investigators think it is the most~     important outcome for the surgeons. The study hypothesis is: Is the exposure rate of a~     local-made polyethylene orbital implant the same as an imported one?~   "
133053|NCT01313559|"~     This is an open label randomized phase II study for prostate cancer patients who have~     disease progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor~     of prostate cancer cells and can prevent them from growing. Everolimus works by targeting a~     cell survival factor in prostate cancer. The combination of these drugs may work better for~     the treatment of prostate cancer without toxic chemotherapy. Patients will receive either~     SOM230 LAR (group A) or SOM230 LAR in combination with Everolimus (group B).~   "
133054|NCT01313546|"~     Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement~     surgery to reduce pain, increase rehabilitation and discharge patients home fast. A lot of~     time, money and hospital resources are invested in inserting these catheters. The aim of~     this study is to compare two end points used for insertion of continuous femoral nerve block~     and to see which one results in fewer failures on the surgical ward.~      Methodology: Patients having total knee replacement surgery will be recruited in this study.~     Patients will be randomized into two groups. The continuous femoral nerve block catheter~     will be inserted using ultrasound and nerve stimulation with two different end points~     (certain muscle contraction).~      Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how~     much pain the patient suffers and how much painkiller the patients used.~   "
133055|NCT01313533|"~     The purpose of this study is to study the effects of polyarginine treated vein grafts on~     graft patency for patients undergoing coronary artery bypass surgery.~   "
133056|NCT01313520|"~     This is a study to compare the effect of infliximab versus placebo on synovial inflammation~     as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is~     that over 14 weeks of therapy, the change from baseline in the volume transfer rate in~     enhancing synovium is larger due to treatment with infliximab than with placebo.~   "
133057|NCT01313507|"~     This is a prospective, open-label, non-controlled, non-randomised multicentre Phase III~     study of two multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks,~     continuing the patient's infusion interval in the main study) for three months.~   "
133058|NCT01313494|"~     The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg~     Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.~   "
133059|NCT01313481|"~     The study aims to assess the effect on functional balance of Otago exercise performed as~     home exercise versus group exercise. The investigators hypothesize that Otago exercise is~     more effective performed as group exercise than home exercise.~   "
133060|NCT01313468|"~     It has been reported that obese individuals are seated 2 ½ hour more than lean individuals~     and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between~     equal size people due to different occupational and leisure time activities. The primary aim~     of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary~     men.~      Subject will be randomized to three different training intervention, with 3 exercise session~     each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7~     day period both before and after training.~   "
133061|NCT01313455|"~     Background:~      - Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the~     secretion of certain hormones, which can lead to reproductive and other issues in women.~     Frequent complications of PCOS include irregular menstruation, development of ovarian cysts,~     and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in~     the production of certain hormones and the regulation of steroid levels in the blood, and~     may be affected in women with PCOS. Researchers are interested in studying possible~     connections between the adrenal glands and PCOS in young women who have been diagnosed with~     PCOS and healthy volunteers with normal menstrual function.~      Objectives:~      - To investigate possible connections between adrenal gland steroid hormone secretion and~     polycystic ovarian syndrome.~      Eligibility:~        -  Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are~          healthy volunteers with normal menstrual function.~        -  Participants must be willing to discontinue the use of oral contraceptives or any other~          medications that alter steroid hormone production for at least 1 month before the start~          of the study.~      Design:~        -  Participants will be screened with a physical examination, medical history, and blood~          and urine tests. All participants will also have a pelvic (ovarian) ultrasound.~        -  All participants will be admitted to the hospital for a 1-week testing period, which~          will involve the following tests:~        -  Regular blood draws for two 2-hour periods (late evening and early morning) to measure~          hormone levels~        -  Fasting blood draws with a dose of corticotropin to test the body's adrenal function~        -  Hormone level measurement following regular doses of dexamethasone (a drug that~          controls the function of the adrenal gland)~        -  Daily urine collection for 6 days.~        -  Other studies, such as imaging studies of the adrenal glands, may be conducted as~          required by the study researchers.~   "
133062|NCT01313442|"~     Background:~      - Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas,~     and colon. Researchers are interested in evaluating how active the immune system is in~     trying to fight the cancer by studying blood and tumor tissue donated from individuals who~     have been diagnosed with gastrointestinal cancers.~      Objectives:~      - To collect blood and tumor samples from individuals who have been diagnosed with~     gastrointestinal cancers in order to study the immune system s response to the cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with throat, stomach,~     gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the~     National Institutes of Health.~      Design:~        -  The study will require at least one but no more than four visits to the National~          Institutes of Health Clinical Center.~        -  Participants will be screened with a physical examination and medical history, and will~          provide a baseline blood sample for study.~        -  Participants will provide additional blood samples 2 and 4 months after the baseline~          sample, as well as a final sample at the completion of the treatment protocol.~        -  Participants will provide tumor tissue samples only if they undergo a surgical~          procedure related to the treatment for their gastrointestinal cancer.~        -  No treatment will be provided as part of this protocol.~   "
133072|NCT01312701|"~     Tumors have a systemic immune modifying effect. They affect the immune system similarly to~     states of chronic inflammation and these effects can:~        -  be monitored through analysis of nk t and myeloid cells mainly through studies of the~          zeta chain but also through other means~        -  may be decreased following effective anticancer therapy - may even be used to study the~          effectiveness of anticancer therapy~        -  are important to monitor if the investigators plan on formulation of systemic immune~          therapy Thus immumonitoring of systemic blood cells may turn out to be an important~          prognostic and predictive factor in many cancer types~   "
133085|NCT01312532|"~     The purpose of this study is to determine which prosthesis is better in total knee~     arthroplasty~   "
133086|NCT01313338|"~     The purpose of this study is to examine the predictability of cognitive representation,~     emotional responses, and hospitalization experience toward the decision to receive treatment~     of the acute coronary syndrome patients.~   "
133063|NCT01313429|"~     Background:~      - Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein~     molecules) on their surfaces. Research has shown that producing an immune reaction to these~     antigens may be able to keep tumors from growing by encouraging the immune system to destroy~     the tumor cells. By creating a vaccine that contains antigens similar to those found on the~     cancer cells, researchers hope to cause an immune reaction that targets the cancer cells.~     However, more research is needed to determine the safety and effectiveness of this type of~     vaccine treatment.~      Objectives:~      - To determine whether a tumor cell vaccine, given to individuals who have had surgery to~     remove malignant tumors from the chest, can cause an immune reaction that will prevent the~     tumors from coming back.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer that has spread~     to the lungs, pleura, or mediastinum, and have recently had surgery to remove tumors in the~     chest.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood tests and imaging studies.~        -  Participants will have the option to have leukapheresis to collect white blood cells~          for studies on how the body is responding to the vaccine. Participants who agree to~          have this procedure will have it before the start of treatment and after the sixth and~          eighth vaccines.~        -  Seven days before the first vaccine, participants will receive the chemotherapy drugs~          celecoxib and cyclophosphamide to take twice a day at home.~        -  Participants will receive the experimental vaccine as an injection in the thigh or arm,~          and may receive it in two shots depending on how many cells are in each vaccine.~          Participants will receive a diary to monitor medication doses and side effects, as well~          as additional cyclophosphamide and celecoxib to take at home as directed by the study.~        -  Participants will have one vaccine every month for 6 months, and will have regular~          blood tests and imaging studies. After the sixth vaccine, participants who have~          successfully responded to the treatment will have two additional vaccines given 3~          months apart.~        -  After the eighth vaccine, participants will have followup visits every 3 months for 1~          year and then every 6 months for up to 4 years....~   "
133064|NCT01313416|"~     Background:~        -  In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer~          carries a poor prognosis with an overall 5-year relative survival rate of 5.6%.~        -  Many doctors believe that individuals who have had surgery to remove pancreatic cancer~          should receive additional treatment, known as adjuvant therapy or adjuvant treatment,~          to prevent the cancer from returning. One chemotherapy drug that has been found to be~          effective in some patients with pancreatic cancer is called gemcitabine; it has been~          shown to improve patient survival by 6 months. Researchers are searching for new drugs~          or drug combinations to improve on these results.~        -  One of the leading causes for immune suppression in cancer patients was suggested to be~          associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human~          B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by~          surrounding cells like regulatory immune cells, resulting in the local suppression and~          apoptosis of tumor infiltrating effector lymphocytes.~        -  Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune~          system from helping in that fight. The experimental drug CT-011 is designed to help the~          immune system remain active to fight cancer cells. CT-011 has been tested in~          laboratories and studied for use with a number of other cancers, but it has not been~          given in combination with gemcitabine as a treatment for pancreatic cancer.~      Objective:~      - To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a~     follow-up treatment for pancreatic cancer that has been surgically removed.~      Eligibility:~      - Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and~     have not had other types of follow-up treatments.~      Design:~        -  Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and~          will be monitored throughout their treatment.~        -  Participants who do not have serious side effects and remain cancer-free may receive~          this drug combination every 28 days for a total of 6 cycles.~        -  Participants will have follow-up visits with additional blood tests every 2 months~          after stopping treatment for up to 2 years.~   "
133065|NCT01313403|"~     Background:~      - Medications to treat major depression act on a brain chemical called serotonin, which~     binds to receptors on brain cells. More research is needed on how serotonin receptors work~     in the brain, and imaging studies such as magnetic resonance imaging (MRI) can provide~     information on how these receptors function in the brains of individuals with depression and~     healthy volunteers. The experimental radioactive chemical [11C]CUMI has been designed to~     react with serotonin receptors, and researchers are interested in studying its effectiveness~     using positron emission tomography (PET) scanning to see how well it gets into the brain.~      Objectives:~      - To evaluate the effectiveness of the radiotracer [11C]CUMI in brain imaging studies of~     serotonin receptors.~      Eligibility:~      - Individuals between 18 and 55 years of age who either have been diagnosed with major~     depressive disorder or are healthy volunteers.~      Design:~        -  Participants will be screened with a full medical history, physical and psychiatric~          examination, blood and urine tests, and questionnaires about mood. Participants will~          also have an electrocardiogram at this visit.~        -  At the first study visit, participants will have a MRI scan of the brain to provide~          baseline data on brain function.~        -  At the second study visit, participants will have a PET scan with the [11C]CUMI~          contrast agent.~        -  No treatment will be provided as part of this protocol....~   "
133066|NCT01313390|"~     RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. It is not yet known whether giving~     everolimus together with docetaxel is more effective than giving docetaxel alone in treating~     patients with head and neck cancer.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus~     given together with docetaxel in treating patients with recurrent, locally advanced, or~     metastatic head and neck cancer.~   "
133067|NCT01313377|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Observation is watching a patient's condition but not giving~     treatment until symptoms appear. It is not yet known whether giving gemcitabine~     hydrochloride together with oxaliplatin is more effective than observation in treating~     patients with biliary tract cancer that has been removed by surgery.~      PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride~     together with oxaliplatin to see how well it works compared with observation in treating~     patients with biliary tract cancer that has been removed by surgery.~   "
133068|NCT01313364|"~     This is a single-arm, single-center study in healthy volunteers. This study is designed to~     evaluate the safety of IM injections using single-use autoinjectors with a 25G × 1 needle.~     The purpose of this study is not to evaluate study treatment; therefore, all injections will~     be performed with Avonex placebo only; no active IFNβ-1a will be administered.~   "
133069|NCT01312740|"~     The investigators evaluated whether an energy-restricted protein diet with low glycaemic~     index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a~     conventional diet (LC-CONV) on weight-loss and related metabolic variables.~   "
133070|NCT01312727|"~     The aim of this study is to identify families with hereditary chronic tubulointerstitial~     renal diseases , characterize the phenotype and screen for mutations in known genesis (UMOD,~     REN, TCF2, NPHP1). Genome wide analysis will be performed in families without mutations~     identified.~   "
133071|NCT01312714|"~     Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated~     with cardiovascular risk factors such as increased aortic pulse wave velocity, blood~     pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect~     of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.~   "
133073|NCT01312688|"~     The cardiovascular system plays a central role in the pathophysiology and prognosis of~     sepsis, yet the correct hemodynamic management of septic patients is still vigorously~     debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate~     prediction of fluid requirement. Recently studies showed that early goal-directed therapy~     (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock~     patients, yet EGDT has not been adopted by all intensivists. The investigators have recently~     found using 2D echocardiography in 262 patients with severe sepsis or septic shock and~     treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and~     reduced stroke volume index are strong independent predictors of mortality. In the present~     study the investigators intend to test the effect of EGDT on resuscitation, on long term~     myocardial function and left ventricular volumes and on survival in ICU patients with severe~     sepsis and septic shock. Patients will be randomized to EGDT (resuscitation directed by~     ScvO2) or standard of therapy for the first six hours after diagnosis of severe sepsis or~     septic shock and admission to the ICU. After six hours patients in septic shock will be~     further monitored with non invasive cardiac output (PiCCO, Pulsion Technologies). All~     patients will be followed daily by 2D & 3D transthoracic echocardiography with detailed~     measurements of systolic and diastolic left and right ventricular volumes and functions.~     Patients in the EGDT group will be compared to the control group for parameters of initial~     resuscitation (fluid volumes, ScvO2 achieved, inotrope use), initial values from non~     invasive cardiac output at six hours, interventions required from institution of non~     invasive cardiac output, early and long term effects on cardiac function and volumes from~     echo measurements, and mortality. The effectiveness of EGDT will thus be examined in the~     short and long terms.~   "
133074|NCT01312675|"~     The purpose of this study is to determine if Selective Adsorption System for Removal of~     Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.~   "
133075|NCT01312662|"~     Purpose of this study is to investigate the agreement, the test-retest reliability of three~     established and widely used visual acuity tests, to develop a mathematical transformation~     routine between the results from these three tests, to assess the examinees´ and examiners´~     acceptance and to compare the test durations.~   "
133076|NCT01312649|"~     The investigators aim is to understand the cognitive mechanisms that contribute to the~     emergence of delusions of control (the belief that one's own actions or thoughts are~     controlled by an external force). These symptoms are mainly encountered in patients with~     schizophrenia, and the investigators will distinguish patients with schizophrenia with or~     without this symptom together with patients with bipolar disorder. Based on the~     investigators previous studies, this project will help to determine the role of two~     elementary mechanisms in the ability to feel in control of voluntary actions: (1) the~     processing of the sensory consequences of action, and (2) the ability to build mental~     representations for sequenced actions.~   "
133077|NCT01312636|"~     This study is conducted in Japan. The aim of this observational study is to evaluate the~     long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in~     subjects with congenital FVII deficiency.~   "
133078|NCT01312623|"~     Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading~     to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive~     ischemic episodes at an organ can reduce damage resulting from consecutive prolonged~     ischemia in that organ. Remote ischemic preconditioning is defined as ischemic~     preconditioning by repetitive ischemic episodes of an organ remote from the organ to be~     protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. Animal~     studies as well as human studies have shown that ischemic preconditioning can protect the~     heart from intraoperative ischemia. Remote preconditioning by repetitive limb ischemia has~     been applied in humans in some studies.12-14 However, the published data is not yet~     sufficient to support evidence based recommendations for clinical practice. In particular,~     available data regarding the influence of remote preconditioning on inflammatory and~     ischemic damage of brain and heart in children following surgery of congenital heart disease~     are limited. Hence, this prospective, controlled and randomized study was designed to~     perform remote ischemic preconditioning in children after induction of anesthesia for~     pediatric heart surgery and to investigate the effect on postoperative organ function in~     comparison to a control group.~   "
133079|NCT01312610|"~     This study is investigating the effect of 8 weeks of orange juice supplementation on~     executive function in healthy older adults. The study is a controled, double-blind,~     crossover trial and involves a 8 week supplementation with a high flavonone orange juice and~     a carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the~     control juice per day for an 8 week period. There is then an 8 week washout period before~     subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm~     at the beginning of the study. Measures of cognitive function will be administered pre and~     post both test and control interventions. Blood pressure will also be measured and blood and~     urine samples will be collected to assess absorption of from the juice. A sub-sample of~     volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow~     information.~   "
133080|NCT01312597|"~     The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid~     levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in~     young adults as a result of acute administration of a fruit-derived flavonoid-rich or~     flavonoid-poor drink.~   "
133081|NCT01312584|"~     The primary propose of this study is to determine how processing, in particular~     alkalisation, alters the vascular effects of high-flavanols foods such as cocoa~   "
133082|NCT01312571|"~     Forty-eight people diagnosed with social phobia in an experimental study that randomized~     into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24)~     or 2) computerized attention training (n = 24). After nine weeks we change the condition of~     the two groups of research participants, which should therefore be given both treatments.~     Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in~     the first round of treatment. Genotyping based on saliva samples takes place before the~     start of treatment, at the first fMRI measurement, for those who voluntarily leave the~     sample.~      Study hypothesis~      How is the brain activity of emotional processing and anxiety affected after completing an~     Internet-based CBT compared with computerized attention training? Does the treatment~     response of an Internet based treatment affects by variations in~     serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3)~     genes?~      How is the genetic variations related to symptoms in social phobia (pre treatment)?~   "
133083|NCT01312558|"~     This study aims to investigate the role of the Mediterranean diet in obese patients with~     Obstructive sleep apnoea-hypopnoea syndrome.~   "
133087|NCT01313325|"~     The purpose of this study is to determine if adding hippotherapy treatment will improve~     balance for children ages 5-17 who have disabilities such as cerebral palsy and down~     syndrome. We also want to find out if by improving their balance the children increase their~     participation in age appropriate activities.~   "
133092|NCT01313260|"~     Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated~     focus but surgical benefits are less clear for patients with a poorly defined focus such as~     non lesional refractory partial epilepsies.~      SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the~     procedure is risky with a limited spatial sampling. The development of non-invasive~     neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize~     SEEG procedures.~      The main hypothesis of this research project is the existence of a network organization~     specific for each patient which allows the generation and propagation of epileptic~     activities. The investigators wish to explore this network using diffusion tensor MRI to~     study structural connectivity and MEG/FMRI to study functional connectivity. The~     investigators will apply tools from the theories of complex networks and dynamical systems~     to characterize the network organization of epileptic process.~      The investigators aimed to identify and localize differences in connectivity parameters~     between individual patients and a control group of healthy volunteers.~   "
133093|NCT01313247|"~     Randomised, double-blind placebo controlled cross-over trial~      Main goal:~      Optimize the medical pain treatment for patients with advanced cancer disease~      Study goal:~      Measure paracetamol's additional analgesic effect in a situation where the patient is~     concomitantly treated with oral opioids eqv. morphine > 100 mg/d.~   "
133094|NCT01313234|"~     The purpose of this study is to investigate whether an intervention consisting of the~     implementation of guidelines about daily systematic pain assessment following a theory based~     education, targeting cancer-related pain and pain treatment, lead to a significantly~     positive improvement in RNs knowledge of, and attitudes towards their pain management.~     Furthermore will the interventions targeting the RNs influence the admitted patient's~     perception of their cancer-related pain?~   "
133095|NCT01313221|"~     To estimate the difference in effectiveness between treatment with etanercept 50 mg twice~     weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN)~     topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.~   "
133096|NCT01313208|"~     This study is designed to evaluate the effectiveness of adding etanercept to disease~     modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid~     Arthritis (RA).~   "
133097|NCT01313182|"~     We hypothesize the application of mupirocin or povidone-iodine to the nares is equally~     effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is~     to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary~     hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery~     requiring implantation of prosthetic material, when the patient receives either nasal~     mupirocin or nasal povidone-iodine prior to surgery.~      Secondary study objectives include:~        1. Measure hospital length of stay and re-admission rates in the mupirocin and~          povidone-iodine groups.~        2. Measure adverse events related to mupirocin and povidone-iodine.~        3. Measure rate of SA resistance to mupirocin.~   "
133098|NCT01313169|"~     The investigators conducted a controlled trial to assess the effectiveness of electronic~     medical record (EMR) reminders, with or without a panel manager, on completion of health~     care proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients~     age 65 or older. The investigators hypothesized that EMR reminders would improve adherence~     to practice guidelines and that benefits would be enhanced with the support of a panel~     manager.~   "
133099|NCT01313156|"~     Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns,~     perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic~     syndrome and type 2 diabetes~   "
133100|NCT01313143|"~     Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to~     that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their~     metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by~     monitoring vital signs, ECG and adverse events.~   "
133101|NCT01313130|"~     Traumatic brain injury can cause permanent problems with thinking, memory, control of~     emotions, organization and planning. Thousands of soldiers, marines, and other military~     personnel have had injuries to the brain due the wars in Iraq and Afghanistan. Very large~     numbers of civilians, up to perhaps 1.5 million people per year, in the United States also~     have traumatic brain injuries caused by car accidents, falls, sports-related injuries or~     assault.~      We don't know very much about traumatic brain injuries right now, but there are some~     important new advances in technology that may help us learn a lot more about these injuries.~     One such advance involves new types of MRI scans that we think will be able to show what has~     happened to the brain after trauma more clearly that regular scans can. The first new scan~     is called diffusion tensor imaging, which shows injury to the axons (the wiring of the~     brain). The second new scan is called resting-state functional MRI correlation analysis,~     which shows how well various parts of the brain are connected to each other. Importantly,~     the new types of scans can be done using regular scanners that we already have in every~     major hospital. The innovation is entirely in how the scanners are used and how the~     resulting pictures are analyzed on a computer after they have been taken. We have already~     tested these scans on some military and civilian patients with brain injury and found them~     to be very helpful so far. Our overall goal is to see whether these new MRI scans will be~     useful for active duty military personnel who have had recent traumatic brain injuries. The~     most important goal will be to see if the amount of injury shown on the scans be used to~     predict how well the patients will do overall over the next 6-12 months. A related goal will~     be to see whether injuries to specific parts of the brain seen by these new scans can be~     used to predict whether patients will be likely to have specific problems like memory loss,~     attention deficit, depression, or post-traumatic stress disorder. We would also like to see~     whether the scans could be even more useful when combined with information about genetic~     factors (inherited from the parents) that can be tested in the blood. Another important goal~     is to compare the effects of traumatic brain injuries caused by blasts or explosions with~     injuries from other causes, to find out what is unique about blast injury. A final goal will~     be to repeat the scans 6-12 months later to see whether the new MRI scans can show whether~     the injuries to the brain have healed, gotten worse, or stayed the same. These new scans~     could help with decisions about whether military personnel can return to duty, what sort of~     rehabilitation and treatment would benefit them most, and what family members should watch~     for and expect.~   "
133102|NCT01313117|"~     This study is being done because peripheral neuropathy, a condition that interrupts~     sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that~     alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to~     paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to~     find the best dose of ALA in patients that receive chemotherapy.~   "
133103|NCT01313104|"~     This clinical trial studies colposcopy and high resolution anoscopy in screening for anal~     dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may~     help doctors find cancer cells early and plan better treatment for cancer~   "
133375|NCT01309204|"~     The purpose of this study was to evaluate the safety and efficacy of~     Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative~     to each of its individual active constituents instilled concomitantly~     (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.~   "
133104|NCT01313078|"~     Background:~      - The best treatment for ovarian and related female reproductive tract cancers is not yet~     known for patients whose disease has not responded to or has recurred after standard~     treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works~     differently from standard chemotherapy, has been approved to treat leukemia and has been~     given to a small number of patient with ovarian and other types of cancer. Because~     pegaspargase may reduce the development of cancer cells and blood vessel cells that~     contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink~     ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms~     from their disease.~      Objectives:~      - To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or~     refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.~      Eligibility:~      - Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer,~     fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one~     operation, chemotherapy, and/or radiotherapy.~      Design:~        -  Before the start of the study, participants will be screened with a medical history,~          blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as~          directed by the study doctors.~        -  Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each~          28-day cycle.~        -  Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)~          at the start of the study, before beginning pegaspargase, and again 6 weeks into the~          treatment. This test will determine if pegaspargase is affecting blood flow to the~          cancer site.~        -  Participants will have a computed tomography scan or other imaging every other cycle~          (approximately every 8 weeks) to determine whether the therapy is affecting the cancer~          site.~        -  The treatment will be repeated as long as the participant tolerates the medication and~          his or her cancer is either steady or improving.~   "
133105|NCT01313065|"~     The purpose of this study is to evaluate the safety and tolerability of IV administration of~     VX15/2503 in patients with advanced solid tumors. The escalation part of the study will~     determine the maximum tolerated dose (MTD).~   "
133106|NCT01313052|"~     The FACT model (ACT + legal leverage in the form of judicial monitoring) will be compared to~     enhanced outpatient treatment (close outpatient follow-up without judicial monitoring).~     Seventy adults with psychotic disorders in Monroe County who are convicted of a misdemeanor~     will be randomly assigned to each treatment group and followed for 12 months. Primary~     outcomes will include criminal justice and mental health service utilization rates,~     treatment adherence, psychiatric symptoms, substance abuse, homelessness, perceived~     coercion, and consumer satisfaction. Service utilization outcomes will be tracked using~     established mental health and criminal justice databases.~      Hypotheses are:~        1. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in~          promoting treatment adherence among high-risk adults with psychotic disorders.~        2. FACT (ACT plus judicial monitoring) will have a greater effect than enhanced TAU in~          preventing arrest, incarceration, emergency department and inpatient hospital use among~          high-risk adults with psychotic disorders.~   "
133107|NCT01313039|"~     If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be~     possible to effectively use hormonal therapy in these patients resulting in improved~     outcomes. The investigators propose a single-arm Simon two-step study to examine whether~     treatment with AZD6244 will result in increased ER expression in ER-negative/low primary~     breast tumors.~   "
133108|NCT01313026|"~     A randomised trial testing the effect of percutaneous nerve evaluation and transanal~     irrigation on bowel function in patients after low anterior resection for rectal cancer.~   "
133109|NCT01313013|"~     question prompt sheet for outpatients suffering from depression. effects on~     patient-doctor-communication during the consultation.~   "
133110|NCT01313000|"~     The objective of this pilot study is to observe the utility of autologous transfer of fat~     collected using ultrasonic assisted liposuction into the upper arms with ultrasonic~     visualization.~   "
133111|NCT01312987|"~     The purpose of this research study is to assess what impact an integrated educational and~     feeding intervention delivered to infants and children has on growth (weight and height),~     development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and~     micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory~     and diarrheal) outcomes. A randomized community trial was used to implement a nutrition~     intervention program consisting of monthly education sessions, a lipid-based nutrition~     supplement, and food vouchers for local staples.~   "
133112|NCT01312961|"~     Primary Objective:~      Investigate the effects of SAR231893 (REGN668) administered subcutaneously (SC) once weekly~     for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbations in~     patients with persistent moderate to severe eosinophilic asthma.~      Secondary Objectives:~      Assess the safety and tolerability of SAR231893 (REGN668) administered SC once weekly for 12~     weeks in patients with persistent moderate to severe eosinophilic asthma.~      Assess SAR231893 (REGN668) serum concentrations following once weekly SC dosing for 12 weeks~     in patients with persistent moderate to severe eosinophilic asthma.~   "
133113|NCT01312948|"~     This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged~     2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV)~     treatment. The participants will undergo a monitored sleep study, followed by a 7 night~     trial of the Pixi mask in the home environment. During the study usability will be measured~     through questionnaires filled in by the parent and clinician.~      The study hypothesis is that the usability of the mask will be superior to the patient's~     usual mask.~   "
133114|NCT01312935|"~     The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in~     Patients Undergoing Percutaneous Coronary Intervention (PCI)~   "
133115|NCT01312922|"~     The overall objective of this trial is to demonstrate clinically relevant superior~     antidepressant efficacy of the fixed dose combination PNB01 (low dose pipamperone and~     citalopram) over reference antidepressant treatment with citalopram alone, and a low dose of~     psychoactive pipamperone alone in patients with moderate to severe Major Depressive~     Disorder.~      This study was specifically designed to assess patient related outcome (PRO) parameters~     using an Interactive Voice Response System (IVRS) via telephone.~   "
133116|NCT01312909|"~     The study is designed to see if varenicline combined with age appropriate (adolescent)~     smoking cessation counseling will help teens quit smoking.~   "
133117|NCT01312883|"~     Postpartum depressive symptoms are a major health problem that affects hundreds of women~     annually. The investgators propose to test an intervention to reduce postpartum depressive~     symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by~     preparing and educating women about specific situational triggers of depressive symptoms, by~     bolstering personal and social resources, by enhancing self-management skills to buffer~     postpartum demands, and by increasing access to existing healthcare and community resources~     available to postpartum mothers.~   "
133118|NCT01312870|"~     The purpose of this study is to determine whether postoperative nutritional support improves~     postoperative outcomes in cardiac patients with malnutrition .~   "
133120|NCT01312844|"~     The primary purpose of this study is to assess the ability of scopolamine to improve the~     antidepressant effects of ECT and to determine whether scopolamine will shorten the time to~     response and remission for patients receiving ECT.~      The hypothesis are:~        1. Patients receiving ECT plus scopolamine will have greater improvement in depression~          symptoms than those receiving ECT plus placebo.~        2. Patients receiving scopolamine in addition to ECT will require fewer ECT treatments to~          obtain response/remission compared to the group receiving ECT plus placebo.~        3. Time to response and to remission in the scopolamine group will be significantly~          shorter compared to ECT alone.~   "
133121|NCT01312831|"~     The purpose of this study is to compare the efficacy and safety profile of a new oral~     vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12~     (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL).~   "
133122|NCT01312818|"~     Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult~     patients of which no grade 4 dose limiting toxicities have been observed in prior studies.~     The pre-clinical synergy of these 2 agents when used in combination along with the lack of~     over-riding toxicities and different mechanisms of action provide strong rationale for a~     clinical trial investigating bortezomib and vorinostat in combination. This trial will use~     the identified Phase II dose which is at or below the maximum tolerated dose for both agents~     which have very acceptable toxicity profiles and such should prove feasible and tolerable in~     this relapsed/refractory ALL population.~   "
133123|NCT01312805|"~     This study seeks to improve physician adherence to four recommendations of the NHLBI asthma~     treatment guidelines:~        1. Improve case detection of asthma among patients with pulmonary symptoms,~        2. Grade all asthma patients asthma, identifying those with persistent versus intermittent~          asthma,~        3. Improve rates of use of controller medications - particularly inhaled steroids - among~          patients with persistent asthma,~        4. Provide an asthma treatment plan for all asthma patients.~   "
133124|NCT01312792|"~     The investigators Study Hypothesis is introduction of modified IMCI guideline for managing~     severe pneumonia in first level health facilities will result in 40% increase in the~     appropriate management (appropriate case management at the first level facility and referral~     compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to~     the comparison arm.~   "
133125|NCT01312779|"~     The purpose of this clinical study is to obtain human clinical data that demonstrates that~     the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is~     a safe and effective replacement heart valve.~   "
133126|NCT01312766|"~     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety~     of two different subcutaneous hMG preparations when administered to patients undergoing~     controlled ovarian stimulation for IVF.~   "
133127|NCT01312519|"~     This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration~     system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is~     that the powered system will reduce the level of patient pain during the aspiration and core~     biopsy procedures and the amount of time needed to perform the procedures.~   "
133128|NCT01312506|"~     This study has two ultimate goals:~        1. Understand how the original melanoma from the skin spreads to the CNS. In order to~          study this we need to collect (and compare) the original skin melanoma, the CNS~          melanoma, as well as any other melanoma that has not metastasized to the CNS.~        2. Develop a diagnostic blood test that will early identify subjects at high risk for~          developing CNS metastasis or patients who may already have CNS metastasis but the MRI~          or the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from~          subjects like you who have melanoma CNS metastases in order to confirm the presence of~          this biomarker.~   "
133129|NCT01312493|"~     This is a non-randomized phase II study of targeted radiotherapy (RT) administered~     concurrently with panitumumab in patients with locally advanced squamous carcinoma of the~     head and neck.~   "
133130|NCT01312480|"~     This is a study of the effectiveness of adolescent smoking cessation interventions in~     pediatric primary care settings. Our specific aims are to:~        1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of~          cessation interventions using practice system changes over time, (including systematic~          screening using charting tools and linkages to adjunct materials, including self-help~          handouts and Internet resources); and~        2. Assess the impact of primary care provider counseling interventions on adolescent~          smoking cessation.~      We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking~     cessation counseling at primary care visits will be more likely to make quit attempts and~     more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months~     after intervention, compared to those who do not receive interventions. In addition, we~     hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use~     will be associated with more quit attempts and better long-term cessation rates.~      We will evaluate provider interventions in up to 120 pediatric practices, recruited from the~     American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based~     research network. Adolescents presenting for care will complete a short baseline survey~     prior to their doctor-visit, and a percentage of participants will be surveyed by phone 4‐6~     weeks after their visits to assess quit attempts and short-term cessation, and again at 6~     and 12 months to evaluate long-term cessation outcomes. We will describe the patterns of~     smoking among youth, and explore how much receiving interventions affects motivation,~     quitting, abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other~     smoking behaviors for adolescent smokers.~   "
133131|NCT01312467|"~     The purpose of this study is to find out whether METFORMIN decreases protein markers in~     colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and~     tolerability of Metformin in decreasing colorectal mucosa in patients with a history of~     colorectal adenomas in the past 3 years and a BMI >= 30, with decimals rounded to the~     nearest whole integer. Metformin as a potential chemopreventive agent for inhibition of the~     relevant molecular pathways involved in human colorectal carcinogenesis.~   "
133132|NCT01312454|"~     The purpose of this study was to assess the safety and efficacy of AL-59412C injected~     intravitreally relative to Vehicle.~   "
133133|NCT01312441|"~     The prevalence of vitamin D deficiency increases as kidney function declines. As a result,~     many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown~     that vitamin D supplementation may improve many aspects of poor health such as heart disease~     and inflammatory markers. The objectives of this study are to determine how supplementing~     dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels~     can be maintained after a 6 month treatment course, and to examine the effect of~     ergocalciferol on biomarkers of inflammation and vascular health.~   "
133134|NCT01312428|"~     The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL)~     instrument in achieving desired acetabular position, desired leg length and offset after~     Total Hip Replacement (THR) reconstruction.~   "
133135|NCT01312415|"~     Total knee replacement (TKR) is associated postoperatively with considerable pain and~     analgesic requirement. Total knee replacement is routinely performed under spinal~     anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize~     that infiltration of the surgical site with peri- and intraarticular levobupivacaine local~     anaesthetic would be an efficacious pain management technique and would not be inferior to~     intrathecal morphine for postoperative pain management.~      We further hypothesize that the use of this surgical site infiltration technique would~     decrease post-operative systemic opioid requirements as well as the side effects associated~     with intrathecal and systemic opioids.~   "
133136|NCT01312402|"~     This study is a prospective, single crossover, double-masked, controlled clinical trial that~     will use topical brinzolamide (Azopt)ophthalmic medication to try to improve the nystagmus~     and visual consequences of nystagmus in patients with infantile nystagmus syndrome (INS).~     Subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1~     and then receive either topical Azopt or placebo three times a day in both eyes for days 2,3~     and 4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye~     movement recordings. After at least one week, this protocol is repeated with the crossover~     regimen being taken by the subject. One week after all medications are discontinued, another~     clinical exam is done before study discharge. The hypothesis is that nystagmus and~     associated visual symptoms will be improved while on the Azopt compared to the placebo.~     There will be a total of 5 visits over a 1-2 month period.~   "
133137|NCT01312389|"~     This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or~     primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity~     of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L)~     administered by intradermal/subcutaneous injection in combination with Ampligen~     (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.~   "
133138|NCT01312376|"~     This is a phase-I clinical trial to determine the feasibility and safety of~     Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of~     Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex~     vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole~     tumor vaccine administered intradermally in combination with Bevacizumab in patients with~     recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA~     OOPD)~   "
133139|NCT01312363|"~     The investigators plan to see what factors can influence the durability of Exelon patch~     treatment in Korean patients with Alzheimer's disease.~      Based on these results, the investigators will find the ways to maximize the effect and~     durability of Exelon patch on Korean patients with Alzheimer's disease.~      After finishing this study, the investigators are going to present the study results at the~     international and national academic meetings or conferences.~      Also the investigators expect that they can publish the result in a journal of in the field~     of neurology or dementia till the winter of 2010.~   "
133140|NCT01312350|"~     The investigators will examine whether 2-cycles of DFP chemotherapy before definitive~     concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally~     advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to~     definitive CCRT alone.~   "
133141|NCT01312337|"~     The investigators will examine efficacy and toxicity of gefitinib in Korean patients with~     EGFR wild tumors diagnosed with direct sequence test.~   "
133142|NCT01312324|"~     We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete~     resection rate in advanced thymic carcinoma.~   "
133143|NCT01312311|"~     The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the~     first-line therapy for recurrent of metastatic nasophayngeal cancer~   "
133144|NCT01312298|"~     Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia)~     anesthesia will result in shorter length of hospital stay for patients undergoing total knee~     arthroplasty.~      Primary endpoint: time from end of surgery until the patient is street ready~      Secondary endpoints: will general anesthesia produce less postoperative pain as compared to~     intrathecal anesthesia? Is there any difference in post operative dizziness between the~     groups.~   "
133145|NCT01312285|"~     The purpose of this study is to see if using a device called the Resonator, that puts out~     very low level electromagnetic fields will help symptoms of painful hip(s)~   "
133146|NCT01312272|"~     Individuals with schizophrenia have been found to have deficits in social cognition, which~     is defined as the functions that are engaged during social interactions. Social cognition~     has been found to be critical in predicting multiple aspects of community functioning. There~     are no currently available medications that have been consistently found to improve social~     cognition in individuals with schizophrenia. Oxytocin functions as a neurotransmitter that~     is thought to be involved in multiple aspects of social behavior and related emotions. In~     this study, we test the hypothesis that acute administration of intranasal oxytocin will~     improve social cognition in individuals with schizophrenia.~   "
133147|NCT01312259|"~     Purpose:~        1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with~          sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder~          syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to~          a frequency of 14 hertz (standard).~        2. The evaluate the efficacy of the two frequency settings on the other associated~          conditions that often coexist in patients with IC/PBS, such as female sexual~          dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD,~          painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the~          vagina).~   "
133186|NCT01311739|"~     The purpose of this study is to assess and compare the pharmacokinetics (PK) of~     cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral~     cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered~     intravenously (IV) (also a commercially-available formulation) to healthy male subjects~     under fasting conditions. The safety and tolerability of oral Eligen® B12~     (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also~     assessed.~   "
133376|NCT01309191|"~     The purpose of this study is to determine whether Minoxidil treatment affects hair growth in~     patients with male pattern baldness or androgenetic alopecia.~   "
133148|NCT01312246|"~     In this study the investigators will include adult patients who are not part of a vulnerable~     patient population. Inclusion criteria include patients who will be undergoing resection of~     part of their colon that will require dividing the IMA. The investigators will use the~     resected surgical specimens for our project. The investigators will use the EnSeal on all~     major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model.~     Due to the nature of the project, we will apply for IRB approval prior to beginning our~     research. The investigators plan to include 60 total patients in the study, 30 at the~     University of Illinois and 30 at Lutheran General Hospital.~      Prior to resection, the investigators will use a sterile caliper to take an in-vivo~     measurement of the IMA and IMV. Immediately after resection, the investigators will remove~     the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The~     investigators will similarly prepare the IMV. The investigators will inspect our vessels for~     any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then~     gentle apply manual traction to remove any blood or clots within the lumen. The~     investigators will measure the outer diameter of the vessels using a digital caliper. If~     there are small branches, the investigators will tie them off with suture. The unsealed end~     will then be attached to the burst pressure tester with suture and it will be tested for the~     bursting pressure. The device measures pressure continuously as it infuses the segment with~     normal saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in~     intra-luminal pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be~     determined by a bursting pressure of less than 100 mm Hg. It should be noted that each~     section would only be pressure-tested once. All of our data will be collected on the~     enclosed data sheet we have created for use in this protocol. The investigators will then~     place the vessels with the original surgical specimen where it will be submitted for routine~     pathological examination of surgical specimens. Twenty five specimens at each site will~     undergo the testing, whereas 5 specimens will be sent to pathology without testing.~      Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel~     smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the~     vessel wall. In addition, the seal will be measured and we will obtain digital images. The~     specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens~     taken from the pool of 25 patients at UIC.~      For our human component, the investigators have estimated the standard deviation and width~     of the confidence interval to be 100 mm Hg each. With a 95% confidence level, the~     investigators expect to require 16 measurements for human specimens from 16 patients~     although the investigators will use 50 patients to allow for errors in obtaining pressures.~      Our timeline for the completion of the projects is 6 months. The investigators plan on being~     able to complete the human burst pressure testing within 6 months.~   "
133149|NCT01312233|"~     The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial~     is to evaluate the clinical effectiveness and feasibility of a collaborative care model~     (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with~     120 older adults over the age of 65 with low back pain of at least 1 month duration.~   "
133150|NCT01312220|"~     To study the correlation of serological growth factors and the hepatic progenitor cells~     involved in liver regeneration of liver failure.~   "
133151|NCT01312207|"~     Objective: To evaluate the clinical manifestations and surgical prognosis of macular~     tractional retinoschisis in proliferative diabetic retinopathy.~      Design: Retrospective case series. Participants: Cases with macular tractional retinoschisis~     with or without combined traction detachment (TRD) in proliferative diabetic retinopathy~     confirmed by optical coherence tomography (OCT) at a single institution between January 2007~     and August 2010.~      Methods: Cases were divided into two groups. Group A had tractional retinoschisis only while~     Group B had TRD with retinoschisis of the elevated retina. Clinical data including OCT~     findings were recorded and analyzed.~      Main Outcome Measures: Demographic data, clinical pictures, surgical results, and OCT~     findings will be compared between two the groups.~   "
133152|NCT01312194|"~     The main objective of this study is the prevention and repair of apical periodontitis in~     lower molars with pulp necrosis after the execution of endodontic treatment in one or two~     visits in adolescent patients. Moreover, it is also observed the frequency of postoperative~     pain in endodontic treatment.~   "
133153|NCT01312181|"~     Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV~     medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality.~     Thus reducing NIDU among HIV infected individuals is critical to their survival and to~     limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced~     brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands~     little from busy medical staff and is well accepted by patients. In a 3-arm randomized~     clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b)~     MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.~   "
133154|NCT01312168|"~     This purpose of this study is to~        1. Determine the change in endothelial dependent vascular reactivity and vascular~          properties~        2. Determine the changes in monocytes activation~        3. Determine the change in pro-inflammatory status~        4. Investigate the effect of six-month CPAP therapy on the above changes in patients with~          OSA~   "
133155|NCT01312155|"~     The study investigates assisted intubation using a videolaryngoscope in anesthesia.~   "
133156|NCT01312142|"~     Weaning from mechanical ventilator is an essential element in the care of critically ill~     intubated patients receiving mechanical ventilation. It covers the entire process of~     liberating the patient from mechanical support and from endotracheal tube.~      The process of weaning involves two-step strategies: 1. Assessment of readiness for weaning,~     including physiological measurement, such as maximum inspiratory pressure, tidal volume,~     respiratory rate and etc. 2. Spontaneous breathing trial.~      Tracheostomy has become an increasingly common intervention in ICUs, especially for patients~     with prolonged mechanical ventilator support.~      Tracheostomy may reduce work of breathing by improving some aspects of pulmonary mechanics,~     such as reducing dead space and decreasing airway resistance, but to date, there is no~     evidence that this is linked to reduction in weaning time or length of stay.~      The investigators believe such improvement in pulmonary mechanic, which may reflect in the~     weaning parameter that respiratory therapist measured before weaning program, may be~     different from that measured before tracheostomy creation.~      The investigators therefore hypothesized that the improvement in pulmonary mechanic for~     patients with weaning failure after tracheostomy may reflect on weaning parameters, and that~     this improvement may be able to predict the subsequent successful weaning from mechanical~     ventilator support.~      Hereby the investigators perform a prospective single-center study to investigate the~     changes of weaning parameters in difficult weaning patients after tracheostomy as a~     predictor of subsequent successful weaning.~   "
133187|NCT01311713|"~     CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2~     (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated~     dose (MTD) of CEP-9722 administered daily to patients with advanced or metastatic solid~     tumors, (Part 2) to evaluate the safety and tolerability of that dose, and to investigate~     whether CEP-9722 has antitumor activity as a single agent.~   "
133188|NCT01311700|"~     The purpose of this study is to test whether early pre-reperfusion metoprolol administration~     in patients suffering and acute myocardial infarction might reduce the size of myocardial~     necrosis.~   "
133189|NCT01311687|"~     The purpose of this study is to compare efficacy and safety of pomalidomide in combination~     with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or~     relapsed and refractory multiple myeloma.~   "
133157|NCT01312129|"~     The overarching objective of this pilot study is to apply both neuroimaging and~     pharmacogenetic tools to the study of alcohol dependence. This proposed research will~     provide a mechanistic test of the function of the genetic variation. The specific aims and~     hypotheses are to test whether Sulfasalazine, as compared to placebo, diminishes~     blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal~     cortex (PFC). To test the hypothesis, we will compare Sulfasalazine treatment with placebo~     treatment on BOLD difference maps for the contrast alcohol minus control. We will also~     explore whether specific genetic variations influence this effect. A double-blind,~     placebo-controlled 2 (Medication: Sulfasalazine 1500 mg vs. placebo control) x 2 (Cue:~     Alcohol Cue vs. Control cue) within-subjects, crossover design will be used to test the~     hypothesis that Sulfasalazine reduces the BOLD response in the striatum and prefrontal~     cortex after exposure to alcohol cues. Twenty alcohol-dependent participants will complete~     two rounds of the study medication followed by an functional magnetic resonance imaging~     (fMRI) scan, during which they will complete an alcohol cue-exposure task. The order of the~     medication condition will be counterbalanced such that subjects will be randomly assigned to~     receive either Sulfasalazine (1500 mg) in the first session and placebo in the second~     session one week later (or vice versa). This pilot study will help to determine whether NMDA~     receptors play a role in cue-elicited activation of key areas of the brain implicated in the~     development and maintenance of substance use disorders. Furthermore, if Sulfasalazine~     reduces cue-elicited activation of these brain regions, as hypothesized; this study will lay~     the groundwork for a larger trial on the efficacy of Sulfasalazine as a treatment for~     substance use disorders.~   "
133158|NCT01312116|"~     The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or~     Internet-delivered psychodynamic therapy (iPDT) performs better for a population with~     generalized anxiety disorder (GAD), compared to a wait-list control condition.~   "
133159|NCT01312103|"~     The purpose for this trial is to test the effectiveness of the first interactive~     internet-based safety decision aid on abused women's exposure to repeat intimate partner~     violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g.,~     knowing the advantages and disadvantages of the relationship, having enough information to~     make a decision) will increase safety-seeking behaviors which in turn will decrease exposure~     to repeat IPV and improve mental health outcomes. Findings from the development and initial~     test of our computerized safety decision aid suggests that it offered abused women privacy~     to consider personalized safety options, informed them about danger in their relationship~     and would be used again if they had access to it through a safe internet site.~      The investigators are conducting a five year experimental trial in four states (Oregon,~     Maryland, Missouri, and Arizona) to address the following aims:~        1. Test the effectiveness of an interactive internet-based safety decision aid on abused~          women's safety seeking behaviors and exposure to violence compared to women assigned to~          control websites. The investigators hypothesize that at three, six, and 12 months~          post-baseline the intervention group will have increased safety seeking behaviors and~          reduced IPV exposure in comparison to the control group.~        2. Test the effectiveness of an interactive internet-based safety decision aid on abused~          women's mental health compared to women assigned to control websites. The investigators~          hypothesize that at three, six, and 12 months post-baseline the intervention group will~          have improved mental health in comparison to the control group.~        3. Test if the effect of an interactive internet-based safety decision aid on abused~          women's mental health and exposure to violence is mediated by the safety decision~          making process and safety-seeking behaviors. The investigators hypothesize that the~          intervention group will have a better decision making process and have greater safety~          seeking behavior over the year in comparison to the control group, and that this better~          decision process and increased safety seeking behavior will mediate improvement in~          mental health and exposure to violence at 12 months post baseline.~      This study will provide much needed new information about safety planning's impact on making~     difficult safety decisions, exposure to violence, and mental health effects.~   "
133160|NCT01312090|"~     1. To test whether chronic intermittent cold exposure is more effective in programmed body~          weight loss when compared to conventional programmed weight loss.~        2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle~          and circulating markers) of treatment with chronic intermittent cold exposure and~          conventional treatment~        3. To measure tissue specific changes of weight loss and the treatment with chronic~          intermittent cold exposure in glucose uptake rate in adipose organ (white and brown~          adipose tissue), liver, myocardium, skeletal muscle and brain~        4. To measure tissue specific biochemical indicators before and after treatment with~          chronic intermittent cold exposure from white adipose tissue and skeletal muscle.~        5. To compare changes in body composition and fat distribution after weight loss using~          chronic cold exposure or using conventional method~   "
133161|NCT01312077|"~     Total hip replacement is a major surgical procedure usually associated with significant pain~     in the early postoperative period. In our hospital, total hip replacement is routinely~     performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus~     opioid in the form of preservative free morphine. The use of 'local infiltration analgesia'~     as an alternative postoperative analgesic technique has been investigated.In this technique~     the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a~     catheter under direct vision which remains in situ and is used to administer local~     anaesthetic in the postoperative period until such time as it is removed (when no longer~     deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48~     hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular~     levobupivacaine local anaesthetic would be an efficacious pain management technique and~     would not be inferior to intrathecal morphine for postoperative pain management.~   "
133162|NCT01312064|"~     The investigators hypothesized that everolimus-based immunosuppressive therapy combined with~     rituximab induction could provide comparable safety profiles for renal transplant patients,~     as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus,~     mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function.~      Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined~     with immunoadsorption with or without IVIG, rituximab could successfully prevent~     antibody-mediated rejection in ABO-incompatible renal transplantation. This study is to~     assess whether a CNI-free regimen including B-cell depleting antibody induction, everolimus~     and MMF results in comparable long-term function without a negative impact on safety or~     efficacy of immunosuppression. This study will be open-label and two-arm randomized (2:1).~   "
133163|NCT01312051|"~     Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular~     disease. A common pathogenetic link among these entities is insulin~     resistance/hyperinsulinemia.~      The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in~     black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the~     relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid~     (FFA) - induced insulin resistance is associated with larger increases in intramyocellular~     lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in~     prepubertal black children is more sensitive to the stimulatory effect of FFA than in~     whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the~     lipotoxic effect of FFA compared with whites. The methods to be used are: the well-~     established CT method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and~     IMCL; intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic~     clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and~     substrate turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body~     MRI for body composition assessments.~   "
133190|NCT01311674|"~     The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer~     plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).~   "
133385|NCT01309074|"~     The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of~     200mg/day) & pregabalin (up to a dose of 300mg/day)for the treatment of symptoms of anxiety~     in patients with epilepsy.~   "
133164|NCT01312038|"~     This study is designed to measure the effects of a chewable Simethicone tablet taken by~     mouth on middle-ear pressure in adults with a common cold and evidence of abnormal~     middle-ear pressure. In children and adults, middle-ear diseases such as otitis media (the~     buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the~     Eustachian tube does not open, does not open often enough or is always open. Simethicone,~     available over-the-counter under several brand names including Gas-X, may help break up the~     bubbles that may block the opening of the Eustachian tube in the back of the nose during a~     cold, allowing air to pass between the nose and middle ear. This study requires a single~     visit to the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If~     eligible for the study, Eustachian tube function testing will be done; the Simethicone~     tablet or placebo (a tablet that looks and tastes like the Simethicone tablet but has no~     active ingredient) will be given and Eustachian tube function testing repeated.~   "
133165|NCT01312025|"~     In conventional laparoscopic cholecystectomy, the cystic duct and artery are clipped by~     metal clips. we propose a new method in which the cystic duct is ligated and the cystic~     artery is cauterized. the investigators compare both methods.~   "
133166|NCT01312012|"~     Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in~     our general population reduced from 15-20%, down to < 1% in the post-vaccination population.~     However, children born to HBeAg positive mothers still may be infected with HBV despite~     immunization. To further reducing the HBV infection in our people, strategies in reducing~     infection rate in this high risk group are mandatory. Previous small scale studies using~     lamivudine treatment in pregnant woman in the third trimester has proved effective in~     reducing children infection rate. The aims of the present study are to conduct a clinical~     trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to~     monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials~     will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at~     20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV~     viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8~     copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir~     300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month~     after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the~     mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV~     vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first~     prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before~     Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6~     months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1,~     6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate~     of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the~     children at 12 months of age, the change of liver function, HBeAg, and viral load in~     pregnant mother after treatment.~      A follow-up study for investigating safety of mothers and children that has been exposed to~     maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant~     hepatitis B virus (HBV) transmissions is conducted. The follow-up study included~     mother-children pairs 2-4 years after delivery of the children.~   "
133167|NCT01311999|"~     To follow-up the latent tuberculosis infection and the risk of developing active~     tuberculosis in patients receiving long-term dialysis~   "
133168|NCT01311986|"~     The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and~     their expression levels in epidermis in AD and ND patients.~   "
133169|NCT01311973|"~     The specific purpose of this study is to describe the relationship between salivary~     phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH,~     vitamin D status and urinary excretion of phosphorus.~   "
133170|NCT01311960|"~     The purpose of this study is to determine whether bevacizumab eye drop is effective in the~     treatment of recurrent pterygium.~   "
133171|NCT01311947|"~     In order to clarify the association between HBV mutations appearing before and during~     interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive~     CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the~     mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations.~     Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and~     deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally,~     statistical analysis will be done to elucidate whether the mutations of preS/S gene and~     BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.~   "
133172|NCT01311934|"~     The acoustic radiation force impulse (ARFI) technology provides real-time measurements of~     tissue stiffness.~      Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation~     and validity studies between visceral ARFI quantification and the referenced Metavir~     fibrosis scoring and to conduct subsequent innovative studies on liver diseases.~   "
133173|NCT01311921|"~     EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However,~     the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from~     asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In~     addition, the severe or fatal case incidence varies significantly differently in different~     areas of Taiwan. Although some viral virulence studies were performed, no clear viral~     virulence factor has been found. Therefore, host factors may be important to the clinical~     outcomes of EV71 infections. In addition, there were significantly different incidences of~     severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or~     severe cases occurred in the central or southern Taiwan in comparison with in northern~     Taiwan. Whether this is related to host factors, social, behavioral or environmental factors~     remains unanswered. To find the most important factors associated with EV71 susceptibility,~     a thorough study involving genetics, social, behavioral or environmental factors among~     different areas of Taiwan is warranted and the findings will provide future prevention of~     EV71 and give help on early precaution and treatment of EV71.~   "
133174|NCT01311908|"~     Reflux esophagitis is a common complication following distal gastrectomy. According to the~     investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in~     pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this~     study, the investigators will investigate the incidence of reflux esophagitis after above~     procedure by the 24-h pH monitoring of esophagogastric junction.~   "
133175|NCT01311895|"~     The purpose of this study is to compare two opioid protocols (H2O and 1+1) for the~     treatment of acute severe pain in the emergency department. The investigators primary~     hypothesis is that the H2O protocol will be more efficacious than the 1+1 protocol in~     Emergency Department patients aged 21-64 years. The primary outcome is the proportion of~     patients in each arm who choose to forgo additional pain medication at 60 minutes.~   "
133176|NCT01311882|"~     This is a study to evaluate next-day residual effects of MK-4305 on highway driving~     performance in healthy, non-elderly participants.~   "
133177|NCT01311869|"~     Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall~     of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the~     uterus). African American women are 3-4 times more likely to have uterine fibroids.~     Currently there is no effective long-term medical treatment for fibroids. Hormones have been~     used for short-term therapy, but they are not used long-term because of the risk of side~     effects. When women stop receiving the hormone therapy often fibroids return. Surgery is the~     common treatment for women who are suffering from abnormal symptoms caused by fibroids.~     Hysterectomy is an effective treatment, however women cannot have children after removal of~     the uterus.~      Epigallocatechin Gallate (EGCG) is one of the main natural chemicals found in green tea..~     Research the investigators have done in the laboratory and in animals leads them to believe~     EGCG may decrease the growth of fibroids.~      This study is intended to determine whether EGCG will cause fibroid tumors to shrink and~     reduce fibroid related symptoms such as abnormal vaginal bleeding and pelvic discomfort.~   "
133178|NCT01311856|"~     The goal of this behavioral research study is to learn if an internet or phone based~     exercise and weight management program can help cancer survivors to lose weight and change~     their eating and exercise behavior.~   "
133179|NCT01311830|"~     This study will develop an intervention for adults who want to support a smoker. The goal of~     the intervention is for the support person to motivate & encourage their smoker to call the~     state Quitline funded by Minnesota ClearWay. The study will examine the efficacy of a~     telephone based intervention for support persons compared to a self-help intervention~     (written materials only).~   "
133180|NCT01311817|"~     This project is a pilot safety and immunogenicity study of transcutaneous vaccination with~     live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing~     influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin.~     Transcutaneous vaccination is needle-less application of materials directly to the skin.~     Healthy adult volunteers (4 per group) will receive either:~        -  Saline (placebo)~        -  Cholera toxin adjuvant alone~        -  L. monocytogenes BMB72 bacteria alone~        -  L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant~      Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm~     dressing. Key primary endpoints include: safety as measured primarily by clinical findings~     (VS, cutaneous exams, and systemic reactions), and immune responses as measured by~     serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma~     ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses~     will be evaluated by skin biopsy in subjects who agree to that (optional). The study will~     begin with 2 roll-in subjects receiving both L. monocytogenes and CT.~   "
133181|NCT01311804|"~     Primary Research Objective:~      The primary objective of this study is to determine efficacy of periarticular parecoxib~     sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management~     in total knee arthroplasty~      Secondary Research Objective:~        -  To determine if perioperative use of parecoxib sodium was associated with improved~          clinical outcomes~        -  To evaluate the safety, in terms of adverse events; serious adverse events and~          tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail~   "
133182|NCT01311791|"~     This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The~     purpose of this study is to investigate Algisyl-LVR™ employed as a method of left~     ventricular augmentation and restoration in patients with dilated cardiomyopathy.~     Algisyl-LVR™ will be injected into the myocardium under direct visualization during the~     surgical procedure.~      This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial~     injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV~     size, restore LV shape, lower LV wall stress and improve global LV function.~      The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)~     from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to~     estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device~      The hypothesis of the study is that there is a statistically significant difference in~     change in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is~     compared to the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.~   "
133183|NCT01311778|"~     Despite the current available therapies for opioid-dependent patients, most patients~     relapse. This research project focuses on the development of a novel compound, cannabidiol,~     to modulate opioid craving in humans based on animal models showing its selective~     effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for~     opioid relapse would be of tremendous medical and public health value.~   "
133184|NCT01311765|"~     The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for~     postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days~     period when compared to conventional (15 days) treatment.~   "
133185|NCT01311752|"~     This study is a Multicentre cohort study with inclusion throughout the full duration of the~     study.~      The primary objective is the study of human papillomavirus related genital pathology in HIV~     positive women.~      The secondary objective are:~        1. To study the characteristics of HPV infection and related disease in the context of~          long term HAART and HIV infection ;~        2. To study the characteristics of atypical cells of uncertain significance detected in~          Pap smears, whose prevalence has dramatically increased in the last years;~        3. To describe cervical cancers observed in the cohort~        4. To study the evolution of recurrent high-grade lesions after surgery~        5. To describe the evolution of vaginal lesions developed after hysterectomy for~          high-grade lesions ;~        6. To describe the specific aspects of surgery for the treatment of cervical lesions~          according to the specific localization in the endocervix in HIV-positive women ;~        7. To study the in situ T cell HPV specific response in cervical lesions and the~          relationship between virological and clinical parameters, host immune status and~          natural history of lesions ;~        8. To initiate a prospective study on anal HPV infection and related disease among women~          infected with HIV.~        9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of~          immunosuppression and a high rate of HPV infection ;~   "
133191|NCT01311661|"~     This study will compare efficacy and safety of different regimens of olodaterol~     administration in asthma (once daily, twice daily) with placebo in a complete cross-over~     design each within one of the two daily dose groups (medium or high daily dose).~   "
133196|NCT01311596|"~     This cohort observation, randomized controlled trial is intended to provide data that icons~     and non-verbal communication improve communication and cooperation with children with~     Autism/communication delay and aid in the transition to an unfamiliar environment. It would~     lay the foundation for future studies and practices of using icons and pictures for the~     whole office visit to enhance communication between the patient and physician/nurse/medical~     staff and cooperation of the patient.~        1. Use icons during triage/check in process to decrease time and increase patient~          compliance. Compare typical children to those with Autism/communication delay.~        2. Use icons during blood draw to improve communication with patients, to help with~          patient understanding, and increase patient cooperation and decrease noise and length~          of procedure.~   "
133197|NCT01311583|"~     Patient education using Teach Back has the potential to increase self-care behaviour in~     heart failure (HF) patients and reduce adverse clinical outcomes. Teach back is an~     interactive teaching method that uses plain language, focuses on key points, and asks the~     patient to verbally recall information just discussed. Questions are asked to confirm~     patient understanding of the information delivered.~      This pilot study will be conducted to evaluate the effectiveness of teach back on self-care~     (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine~     if teach back affects the number of ER visits and re-admissions post discharge. The study~     will also assess if teach back technique is a feasible, acceptable and sustainable method of~     discharge teaching for hospitalized HF patients at St Michael's.~   "
133198|NCT01311570|"~     The primary objective of this study is to assess the therapeutic effect of Buprenorphine in~     MDD population.~      The secondary objectives of this study are to assess the therapeutic effect, the feasibility~     and safety of buprenorphine in a MDD population.~   "
133199|NCT01311557|"~     The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced~     Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10~     years of age.~      Primary Objectives:~        -  To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years~          of age to those induced by Adacel in persons 11 to <12 years of age.~        -  To compare the booster responses against pertussis antigens induced by Adacel in~          persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of~          age.~        -  To compare booster responses against tetanus and diphtheria induced by Adacel in~          persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of~          age.~      Secondary Objective:~        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel in~          persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of~          age.~   "
133200|NCT01311544|"~     The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the~     etiologic of stroke. However, the techniques usually used provide only static evaluation~     (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed~     for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could~     be used to review the supraaortic vessels. This MRA offers the following advantages: short~     acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic~     arteries), 3D spatial resolution and high temporal resolution. These qualities are even more~     optimal with a high magnetic field (3T). The high temporal resolution is interesting because~     it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of~     vascular filling and to assess the vascular supply of the infarcted territory. This sequence~     is classified as a 4D MRA.~   "
133201|NCT01311531|"~     The treatment of unstable, non-reducible distal radial fractures is still controversial. The~     aim of the present study is to compare the subjective, clinical and radiographic outcome of~     the TriMed fragment-specific system with a volar locking plate in patients with unstable,~     non-reducible and also redislocated distal radial fractures.~   "
133202|NCT01311518|"~     The objective of this study is to evaluate the safety and tolerability of two active doses~     of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial~     infarction receiving percutaneous coronary intervention angioplasty with or without stent~     placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses~     of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3~     consecutive days and weekly for 4 more weeks.~   "
133203|NCT01311505|"~     This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2~     Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer~     Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg~     rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to~     determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these~     subjects.~   "
133204|NCT01311492|"~     Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving~     a physcial activity program versus a healthy lifestyle program, with one year follow-up in~     30 non-disabled, community-dwelling persons, age 65 and older.~   "
133205|NCT01311479|"~     The proposed study will evaluate the effectiveness of Osteopathic manipulation of the~     sacro-iliac joint (SIJ) and the lumbar spine in symptomatic female interstitial cystitis~     (IC) patients with sacro-iliac joint dysfunction.~      It is predicted that Osteopathic manipulation for a period of 12 weeks will result in~     subjective indices of increased comfort and objective indices of lower O'Leary-Sant~     Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index~     (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased~     frequency on voiding diary and greater variation in resting/contraction perineometry scores.~   "
133206|NCT01311466|"~     Patients with uveal malignatnt melanoma with liver metastases have a dismal prognosis with a~     median survival of less than 12 months. There is noe established treatment showing increased~     overall survival. In this study we will determin if liver transplantation will result in~     long term survival in patients with liver only metastases from uveal malignant melanoma.~   "
133207|NCT01311440|"~     In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat~     children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a~     treatment option for children up to 18 years.~      We now initiate an open, prospective, randomized and controlled study with the aim to test~     the efficacy of treatment with modified Atkins diet in adults with focal and generalized~     epilepsy diagnoses, in order to evaluate whether this treatment should be offered to~     patients on a permanent basis.~   "
133208|NCT01311427|"~     Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in~     patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a~     larger randomized, controlled clinical trial in a community-based setting. We also sought to~     extend this line of inquiry by closely examining Tai chi's effect on physical function,~     specifically postural stability. Towards these ends, we conducted a single-blind, randomized~     controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to~     standard education. Subjects in both conditions meet in small groups two times weekly for 60~     minutes over 12 weeks.~   "
133209|NCT01311414|"~     During clamping of one internal carotid artery for endarterectomy, blood flow through this~     vessel has to be compensated by collateral arteries including the contralateral internal~     artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this~     collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping~     and ischemic brain damage is likely to emerge. To maximize cerebral blood flow during~     clamping, increase of blood pressure is a common procedure and routine at our institution.~     Increasing blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin~     (Akrinor®) until the designated blood pressure is reached. After declamping, the blood~     pressure has to be reduced to normal values to avoid postoperative hyperperfusion syndrome.~     This is enabled by tapering urapidil until normal blood pressure is achieved.~      It has been shown that cerebral oxygenation measured by near infrared spectroscopy is~     reduced by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine~     increases cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin~     and urapidil may also have an effect on cerebral perfusion. In this prospective randomized~     study the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by~     near infrared spectroscopy is investigated.~   "
133210|NCT01311401|"~     The aim~      The aim of the present study is:~        1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians~          population-based sample of people who were aged 35 years or older and living in Israel.~        2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.~      The hypothesis of the study:~      High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in~     the future.~      The claimed importance of the study:~      Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying~     the preventive measures in a small part of the population, by that to reduce the incidence~     of new diabetes without increasing the health cost.~   "
133211|NCT01311388|"~     The investigators want to achieve the goal of diagnosis in early phase, accurate treatment~     and existence for a long period in order to screen in early phase, diagnose in clinical~     trial, choose treatment and evaluate prognosis of cancers by establishing molecular~     pathology tools.~   "
133212|NCT01311375|"~     The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological~     recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One~     hundred spinal cord injured patients who come to clinic of spinal injury repair research~     center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg)~     in the intervention group and placebo in the control group. Primary outcome measures are~     professionals evaluation of neurological function by using :~        -  ASIA scale for sensory and motor function~        -  FIM scale for Functional potential~        -  FAM~        -  SF_36 for quality of life~      Lipid profile and Antioxidant profile evaluation by using:~        -  FBS~        -  2hpp~        -  Insulin~        -  LDL~        -  Total cHOL~        -  TG~        -  HDL~        -  Leptin Adiponectin -Calcium-~        -  25OHD~        -  PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of~          :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL~        -  BMD~   "
133213|NCT01311362|"~     The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady~     state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (*2 and *3~     allele vs. wild type; ~2-5% poor metabolisers in Caucasian population) on the~     pharmacokinetics of ambrisentan in healthy volunteers.~   "
133214|NCT01311349|"~     Various bacterial organisms will be tested in order to compile information regarding the~     effectiveness of tigecycline against certain bacteria seen in local communities.~   "
133215|NCT01311336|"~     The purpose of this study is to determine the incidence of pegfilgrastim-induced back and~     leg pain and to determine whether the antihistamine loratadine can prevent~     pegfilgrastim-induced back and leg pain.~   "
133216|NCT01311323|"~     MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary~     artery disease and/or with left main narrowing who present symptoms of acute ischemia. For~     such kind of patients according to current ACC/AHA guidelines CABG (surgical~     revascularization) is recommended as a treatment method. In comparison with CABG, recent~     studies have shown that PCI (percutaneous coronary intervention) is associated with a lower~     rate of periprocedural adverse events and similar long term event-free survival in patients~     with left main disease. Our latest non randomized registry and randomized LEMANS study,~     comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings.~     LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA~     (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward~     lower one year mortality after PCI when compared with CABG. It should be stressed, that~     acute ischemia substantially increase the risk of CABG. In fact, there are limited data on~     the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).~      Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included~     mainly patients with stable angina, small cohort of patients with unstable angina and they~     excluded patients with non ST elevation Myocardial infarction.~      In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low~     perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High~     perioperative risk patients were included only in PCI registry.~   "
133217|NCT01311310|"~     This study is conducted in order to evaluate the effect of remote ischemic preconditioning~     on children undergoing cardiac surgery, especially focusing on possible differences~     according to preoperative cyanosis.~   "
133218|NCT01311297|"~     A single- center prospective observational study. This study evaluates different aspects of~     endothelial function. It investigates the endothelial leakage with the venous occlusion~     plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.~   "
133219|NCT01311284|"~     Nasotracheal intubation is usually required in oral surgery to allow an unrestricted~     surgical approach. The standard method is generally performed using the Macintosh~     laryngoscope supported by Magill forceps. However, it is recommended to perform awake~     tracheal intubation in situations where a difficult airway is predicted, a scenario where~     this technique may be poorly tolerated by the patient. Although fibreoptic intubation is~     considered the gold standard, sometimes it is difficult to perform and,therefore,~     alternatives are necessary. The hypothesis is that optical laryngoscopes as the Airtraq~     nasotracheal and Mcgrath can improve the time and/or success of nasotracheal intubation in a~     manikin.~   "
133220|NCT01311271|"~     The aim of this multicentric double blind study (randomized study) is to demonstrate the~     relationship between the amount of rTMS and the efficacy in the treatment of upper extremity~     motor deficits of stroke patients.~   "
133221|NCT01311258|"~     This study is being performed to develop assays to determine the impact of the therapy~     patients receive for treatment of AML or MDS and to determine if these tests can identify~     those patients who are at a greater risk for having their disease relapse.~   "
133222|NCT01311245|"~     The aim of the randomized controlled trial was to test two behavioral interventions among~     job-seekers with risky drinking. The interventions differed in their theoretical background:~     Intervention A was tailored to the stage of change, and Intervention B was~     non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky~     drinking at three job-agencies. Job-seekers with risky drinking were asked to participate in~     the study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The~     baseline assessment was self-administered using handheld computers. The follow-up~     assessments by interviews on the phone, primarily. Both intervention groups received~     individualized computer generated feedback letters at baseline and 3 months later.~   "
133223|NCT01311232|"~     This study is a retrospective analysis to identify factors influencing hepatitis B virus~     reactivation in patients treated with rituximab containing chemotherapy. Rituximab~     monoclonal antibody targeting CD20 induces B-cell depletion resulting in prolonged immune~     suppression. This leads to frequent reactivation of patients with a previous history of~     exposure to HBV or HBV carrier.~      We collect the clinical features and laboratory findings of patients satisfied the inclusion~     criteria as follows.~        1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell~          lymphoma (FL).~        2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a~          primary treatment~        3. Patients with a history of previous exposure to HBV~             -  HBV surface antigen (HBs Ag) positive Or~             -  HBV core antibody (IgG anti-HBc antibody) positive~      Then, we compare the HBV reactivation group with the control group (HBV reactivation does~     not happen) to find factors influencing HBV reactivation.~   "
133224|NCT01311219|"~     Patients with acute, displaced fractures of the middle third of the clavicle will be~     randomly assigned into either the non-operative treatment group or the operative treatment~     group. The operative treatment group will be randomly assigned to repair with either an~     intramedullary device or a plate and screws.~   "
133225|NCT01311206|"~     The objective of the proposed research is to assess the efficacy of an eight-week, efficient~     and tolerable, low-intensity resistance-training program with concurrent application of~     partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women~     with risk factors for incident symptomatic or progressive knee OA. This specific aim will be~     achieved through a randomized, controlled trial, comparing low intensity training with and~     without PBFR. There have been numerous reports of exercise interventions in people with knee~     osteoarthritis. However, this research is novel in that it will be the first to use a low~     intensity regimen that will minimize forces on the knee while still having the potential to~     lead to clinically meaningful strength gains in older adults with risk factors for incident~     symptomatic or progressive knee OA.~   "
133226|NCT01311193|"~     Individuals with borderline personality disorder (BPD) frequently suffer from emotional~     instability, daytime fatigue and sleep disturbances. The investigators examined circadian~     rhythms, sleep and well-being in women with BPD under their habitual life conditions with~     and without light treatment.~      Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with~     morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together~     with proximal skin temperature. Saliva samples were collected weekly to determine the~     diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess~     depression and clinical state throughout the 6-week protocol. Ten matched healthy women~     followed the same 6-week protocol without light treatment.~   "
133227|NCT01311180|"~     Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown~     potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in~     animal and human studies. Furthermore, controlled, single site human studies have shown the~     anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel~     Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with~     Generalized Anxiety Disorder. The primary objectives of this study are to assess the~     efficacy and safety of Sensoril® for patients with moderate or greater severity of symptoms~     associated with Generalized Anxiety Disorder.~      The Primary Efficacy endpoint in this study will be determined by a statistically~     significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale~     scores in the Sensoril® treated group versus those receiving placebo.~      The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo~     results in:~        1. Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last~          value)~        2. Greater remission rates (HAM-A total scores ≤ 7) at week 8~        3. Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety~          cluster scores.~        4. Greater improvements on CGI - severity scores from baseline to last value.~        5. A higher percentage of subjects rated as much improved or very much improved on the~          CGI - Improvement subscale at the last value.~        6. Serum cortisol and DHEA-S levels will be assessed between the two treatment groups.~          These biomarkers are indices of stress and it is hypothesized that improvement in~          levels of these stress indices will favor the Sensoril® treated group.~      Exploratory Endpoint~      1. Patient reported outcomes for sleep and calmness will be assessed between the two~     treatments.~      Safety Endpoint~      The safety endpoints will be determined by assessments of adverse and serious adverse~     events, physical examination, vital signs, EKG, and clinical laboratory measures. Clinical~     measures with laboratory defined reference ranges and vital signs will be assessed.~   "
133228|NCT01311167|"~     Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is~     possibly related to the increased effect of steroid hormones on salt reabsorption in the~     kidney. By reducing overall steroid production with the dexamethasone the accumulation of~     salt and water could be prevented.~   "
133265|NCT01310673|"~     Medical teaching suggests allopurinol should not be initiated in the setting of an acute~     attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests~     the hypothesis that there is no difference in patient reported daily pain or flair~     occurrences with early versus delayed institution of allopurinol during an acute gout~     attack.~   "
133229|NCT01311154|"~     The proposed study is distinctive in studying known carriers of resistant~     Enterobacteriaceae. It examines both phenotypic and genotypic expansion in the AMR bacterial~     population as a function of antibiotic treatment, and examines the effect of antibiotics on~     the dissemination of resistance genes from species to species. It will examine CRE,~     important emerging pathogens, which are a significant threat to public health, but yet not~     well studied. The proposed study will use an interdisciplinary approach, combining PK/PD,~     phenotypic, and genetic data to understand the effect of antibiotics on the likelihood of~     spread of AMR. Most previous studies have focused on the effect of antibiotic agents on~     clinical detection, infection or acquisition of AMR among non-carriers67,68. Other studies~     have looked at the effects on colonisation-resistance mostly among healthy volunteers69.~     Very few studies have examined the effects of various antibiotic agents on carriers of ARB~     and those focused primarily on vancomycin resistant enterococci (VRE)70. No similar studies~     have been conducted with regard to ESBL or to CRE. Correlation with clinical factors and~     environmental contamination has not been determined in previously published studies. The~     proposed study also extends the analysis to the effect of antibiotic treatment on~     dissemination of resistance genes which may be of great importance as these events may lead~     to emergence of new AMR strains and species. The proposed study not only examines the~     effects of various antibiotic agents and classes, but also the effects of duration of~     treatment and PK/PD indices on amplification of ARB. The study will also examine the effect~     of antibiotics on the epidemicity and fitness of colonising strains~   "
133230|NCT01311141|"~     In the present study we will measure and compare the unbound, i.e. microbiologically active~     concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose~     tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis~     technique, which allows for the continuous measurement of unbound drug concentrations in the~     interstitial space fluid. The findings of the present study will help to assess whether~     currently employed therapy regimens with doripenem provide effective antimicrobial~     concentrations in different compartments in man~   "
133231|NCT01311128|"~     This protocol will test a new non-invasive device, the T-line, in continuously determining~     heart rate and blood pressure in operative and critically ill patients. The accuracy of the~     device will be compared to the standard radial artery catheter, as well as to the~     non-invasive blood pressure cuff. The T-line will also be compared to the right heart~     catheter determining cardiac output in at least 20 patients.~      Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as~     a standard radial arterial catheter and a blood pressure cuff in perioperative patients.~   "
133232|NCT01311115|"~     This study proposes a novel behavioral intervention to help smokers in Thailand to achieve~     their goals of quitting. Smoking treatment programs are rare throughout most of Asia and~     unlikely to meet the impending demand for quitting that tobacco control regulations is~     stimulating. New approaches are needed.~      The present study is a randomized controlled trial to test the effectiveness of a novel,~     scalable approach to smoking cessation that is targeted toward rural Southeast Asian~     communities. Thailand is used as a test case to explore if pairs of smokers quit~     successfully after making financially-backed commitments and receiving cash incentives to~     quit. The control group receives education and counseling about quitting. In addition to~     education and counseling about quitting, the intervention includes two key components:~        1. Each participant is encouraged to deposit his cigarette money on a weekly basis, to~          be returned only if the smoker quits successfully within three months. Such commitment~          contracts, based on theory from behavioral economics, are designed to help a person to~          maintain self-control and motivation in the face of temptation.~        2. Each participant is paired with another study participant. If both quit, each receives~          a cash bonus. The joint incentives are designed to lead partners to support each other~          throughout the quit attempt.~      Thus, group commitment contracts marshal a robust blend of elements: financial commitment,~     social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will~     clarify the relative importance of each of these elements.~   "
133233|NCT01311102|"~     The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will~     reduce pain scores related to that procedure. In a double blinded randomized trial of 60~     women receiving either normal saline or lidocaine infused through an endometrial aspirator,~     pain scores will be obtained for each step of the IUD placement procedure and for the total~     experience.~   "
133234|NCT01311089|"~     Most patients with thyroid tumors are effectively treated surgically by practitioners~     experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing~     thyroid surgery are concerned about the postoperative cosmetic appearance of the neck.~     Robotic thyroidectomy which can hide the operative scar was associated with a higher degree~     of patient cosmetic satisfaction.~   "
133235|NCT01311076|"~     The purpose of this study is to compare the safety, tolerability, pharmacokinetic and~     pharmacodynamic properties of single doses of TAK-329 with a single dose of a~     subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes~     mellitus.~   "
133236|NCT01311050|"~     A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with~     Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer~   "
133237|NCT01311037|"~     The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal~     Women with Advanced Breast Cancer A Prospective Trial.~   "
133238|NCT01311024|"~     The purpose of this study is to assess the indirect effects of a pneumococcal conjugate~     vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7~     years.~   "
133239|NCT01311011|"~     Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with~     Critical Limb Ischemia~   "
133240|NCT01310998|"~     The purpose of this study is to study the acute psychological effects in patients with~     schizophrenia after one session of high intensity exercise.~   "
133241|NCT01310985|"~     A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam~     Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized~     (Non-Metastatic) Rectal Cancer~   "
133242|NCT01310972|"~     Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX~   "
133243|NCT01310959|"~     Establishing a Data Base for Aplastic Anemia and Other Marrow Failure Syndrome~   "
133246|NCT01310920|"~     Evidence has been documented for the close relationship between the arrhythmia pathogenesis~     and the gene expression in renin-angiotensin system. However, it remains unclear for~     involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers~     thus investigated the possible relationship between non-familial sick sinus syndrome and the~     polymorphism and haplotype of the AGT promoter.~   "
133247|NCT01310907|"~     Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major~     cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as~     by mutations at particular ion channels, limited information is available for the~     mechanistic study in non-familial bradyarrhythmia.~      Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison~     of multi-locus analysis and single-locus analysis will be analyzed between the cases and~     controls. Functional studies will perform to clarify the results of association study.~   "
133248|NCT01310894|"~     The aims of this study are:~        -  to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on~          the rate of absence of definite cancer using patients on active surveillance as a~          comparison (co-primary objective A) and~        -  to determine the difference in rate of treatment failure associated with observed~          progression of disease from low risk prostate cancer to moderate or higher risk~          prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active~          surveillance (co-primary objective B).~   "
133249|NCT01310881|"~     This is a subject single blinded, randomized, placebo-controlled, single dose,~     first-time-in-human study with three or more ascending cohorts.~   "
133250|NCT01310868|"~     RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving~     radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells~     that remain after surgery.~      PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery~     with 5-ALA given together with Gliadel wafer, followed by radiation therapy and~     temozolomide, in treating patients with primary glioblastoma.~   "
133251|NCT01310855|"~     RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is~     not yet known whether cediranib maleate given together with gefitinib is more effective than~     cediranib maleate given alone in treating patients with recurrent or progressive~     glioblastoma.~      PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib~     maleate together with gefitinib and to see how well it works compared with giving cediranib~     maleate together with a placebo in treating patients with recurrent or progressive~     glioblastoma.~   "
133252|NCT01310842|"~     The goal of this study is to learn about the influence of the social and physical~     environment on smoking cessation (quitting smoking) among smokers.~   "
133253|NCT01310829|"~     The goal of this study is to evaluate a virtual reality-based intervention for training~     health care providers who are not genetics specialists to effectively communicate with and~     counsel patients regarding cancer genetics.~   "
133254|NCT01310816|"~     IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in~     patients with Chondrosarcoma.~   "
133255|NCT01310803|"~     This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the~     efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with~     valrubicin following induction with valrubicin as compared to induction with valrubicin only~     in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be~     stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last~     bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).~   "
133256|NCT01310790|"~     The impact of lactate guided therapy on septic shock has not been extensively investigated,~     however the goal directed therapy has been used for years. The investigators aim was to test~     the hypothesis that lactate directed hemodynamic therapy is associated with improving the~     outcome of patients with septic shock by comparing different goal directed strategies which~     have been commonly recommended clinically.~      In this multicenter, randomized trial, the investigators assigned patients with septic shock~     to three groups: Patients were treated with hemodynamic therapy directed either by~     conventional parameters treatment (control group), or central venous oxygen saturation~     (ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of~     death at 28 days after randomization and in-hospital mortality; secondary end points include~     hemodynamic states, time to goal-achievement.~   "
133257|NCT01310777|"~     The purpose of this study was to evaluate the safety and efficacy of~     Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its~     individual active components in patients with open-angle glaucoma or ocular hypertension.~   "
133258|NCT01310764|"~     The purpose of this study is to investigate the safety and efficacy of bevacizumab as an~     adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this~     new drug to the most commonly used anti-scarring agent, mitomycin C.~   "
133259|NCT01310751|"~     The aim of this study is to determine whether inhaled iloprost can be used to prevent and~     treat PH and PHC while in children after operation of CHD~   "
133260|NCT01310738|"~     This study is aimed to compare the efficacy and safety of medications currently used in~     Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects~     of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal,~     and a combination of meglumine plus the liposomal amphotericin B formulation. The study is~     designed to demonstrate the difference in efficacy measured as cure rate at six months after~     treatment and the safety profile based on the adverse event rate observed with each~     intervention.~   "
133261|NCT01310725|"~     The aim of the study is to evaluate the patency in different kinds of vessels used as graft~     material in coronary artery bypass grafting.~      The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the~     same, or better, patency compared to radial grafts and that skeletonisation of the left~     internal mammary artery does not effect the patency for this graft.~   "
133386|NCT01309061|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with~     progressive hemifacial atrophy.~   "
133266|NCT01310660|"~     Prospective studies to date have identified that the levator ani muscle injuries occur in~     14-19% of women after vaginal delivery.~      In none of studies a vaginal examination was performed at the time of delivery. It has~     previously been shown that sonographic injuries of the anal sphincter that were believed to~     be occult were in fact clinically apparent but not recognised at the time of delivery. It is~     therefore important to correlate clinical findings to ultrasound images.~      3D endovaginal endosonography has not previously been used to identify levator injuries.~     This should potentially provide a better view of the pelvic floor muscles.~      The relationship between levator injury and symptoms of pelvic floor dysfunction has not~     been previously established using validated questionnaires. In this study, we include~     validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal~     symptoms. As symptoms may become apparent only in the long term it is prudent that the women~     are followed up in the long term.~      The principle objective is to establish the incidence of levator muscle defects during~     pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor~     and damage to this muscle can potentially cause urinary, bowel and sexual problems and~     pelvic organ prolapse.~   "
133267|NCT01310647|"~     The aim of this study is to compare the effectiveness of testosterone,estradiol and a~     combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low~     responder patients.~   "
133268|NCT01310634|"~     The overall goal of this project is to elucidate the epidemiology of anxiety and depression~     in parents of hospitalized neonates and test a comprehensive intervention program to prevent~     anxiety and depression in parents in this setting.~   "
133269|NCT01310621|"~     The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment~     of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with~     the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium~     inhibits surfactant function directly and also decreases its synthesis by its toxic effects~     on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration~     syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies~     with meconium aspiration. Surfactant replacement alone does not remove meconium from airways~     and multiple doses may be required .Therefore an effective therapy to improve outcome is~     crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown~     to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by~     many pilot studies. So the investigators have decided to study the role surfactant lung~     lavage in the treatment of meconium aspiration syndrome.~   "
133270|NCT01310608|"~     Patients undergoing cardiac surgery frequently develop neurologic complications, ranging~     from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of~     complications is commonly caused by embolization in the brain due to manipulation of~     atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA~     atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan,~     to reduce the risk of embolization and thus subsequent neurologic complications.~      Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound~     scanning has become the gold standard, but is seldom used as it interferes often with~     surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE)~     is a widely used imaging method permitting evaluation of the aorta preoperatively, but~     assessment of distal AA is hampered by interposition of air-filled trachea between esophagus~     and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a~     fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the~     A-View® have successfully been shown in previous studies. The hypothesis of this study is~     that the use of A-View will reduce cerebral embolization secondary to a change of surgical~     technique.~   "
133271|NCT01310595|"~     To investigate the effect of cervical manual mobilization on head repositioning accuracy and~     postural balance in patients with chronic mechanical neck pain in a randomized controlled~     trial. Hypothesis: There is no difference between the intervention group (manual~     mobilization) and control group head repositioning accuracy and postural balance.~   "
133272|NCT01310582|"~     Numerous studies demonstrate that patients have improved immediate recovery characteristics~     following desflurane anesthesia compared to other volatile agents, including sevoflurane.~     There is limited evidence in the literature to suggest that patients undergoing sevoflurane,~     compared to desflurane anesthesia, may suffer from limitation in function and cognitive~     ability for an undetermined, but prolonged period of time following surgery. These~     differences are not explained pharmacokinetically and may be a result of a direct neurotoxic~     effect of sevoflurane. An unresolved question is the time required for the ability to return~     to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not~     to drive or make important decisions for 24 hours following anesthesia, but this is not~     well-studied and proscribed on an empiric, rather than scientific, basis with very limited~     data available.This study will better define recovery characteristics and characterize the~     severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia~     after brief outpatient urologic surgery in elderly females using tests of cognitive ability~     coupled with performance on a driving simulator and cognitive task tests to objectively~     measure not only testing performance, but also cognitive effort in performing these tests.~   "
133273|NCT01310569|"~     This study aimed to search whether whole body and subcutaneous adipose tissues increase in~     PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin~     levels.~   "
133274|NCT01310556|"~     This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the~     patients with coronary artery disease and the relationship between different GMDs and~     coronary artery disease (CAD).~   "
133284|NCT01310426|"~     Vaginal delivery may cause various levels of damage to the anal sphincter. According to the~     literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal~     delivery suffer from fecal incontinence. This has an adverse effect on the quality of life.~     Different risk factors such as: first births, instrumental delivery, high birth weight,~     prolonged second stage, epidural anesthesia etc. were assessed and found to be associated~     with anal sphincter disruption. The purpose of this study is to assess risk factors for anal~     sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D~     transperineal US).~   "
133275|NCT01310543|"~     Teens and Toddlers is an intervention that enables young people at risk of teenage pregnancy~     to spend time mentoring a toddler as well as participating in counselling and classroom work~     focused on youth development. This trial aims to test primary hypotheses that girls age~     13/14 who are randomly allocated to participate in the T&T intervention are more likely to~     report use of contraception at last sex, less likely to report frequent sex without~     contraception over the previous 3 months, less likely to expect to become teenage parents~     and more likely to report high scores for youth development indicators one year after the~     intervention than are similar girls who are randomised not to participate. The trial~     involves a total of 180 girls per arm and is being conducted across England funded by the~     Department for Education and conducted by the London School of Hygiene and the National~     Centre for Social Research.~   "
133276|NCT01310530|"~     The purpose of this is to determine the efficacy and toxicity of proton therapy when used to~     deliver partial breast radiotherapy in patients with early stage breast cancer with low or~     intermediate risk factors.~   "
133277|NCT01310517|"~     The purpose of the study is to directly compare two methods of evaluating heart function at~     the time of your angiogram. In both methods contrast dye is injected into the main heart~     chamber during the angiogram while x-ray images are taken. One method uses an automatic~     power injector to deliver the normal volume of contrast; the other method uses hand~     injection of very low volume of contrast into the main heart chamber. It is hypothesized~     that hand injection will prove to be an accurate method to estimate ejection fraction (EF)~     at the time of radial coronary angiography when compared directly to Power LV.~   "
133278|NCT01310504|"~     Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for~     Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage~     patients. Volunteers in the study will include peritoneal dialysis patients (non stable)~     and non-peritoneal dialysis patients (stable). They will use the ultrasound to perform~     FAST scans on the patients to determine which subjects are stable and which are unstable~     patients. They will record which patients they consider need transport first. This data will~     be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free~     fluid within the volunteer, they will be able to make the decision to upgrade these patients~     and ultimately transport them more quickly. The paramedics will be evaluated for time and~     accuracy with the FAST scan.~   "
133279|NCT01310491|"~     The purpose of this trial is to determine if by structured telephone based health coaching~     programme supported by remote monitoring system among type 2 diabetes, coronary artery~     disease and heart failure patients the investigators are able to improve their quality of~     life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among~     those type 2 diabetes patients who had elevated value of HbA1c when recruited.~   "
133280|NCT01310478|"~     To investigate safety and tolerance of dose-escalation of infusional recombinant human~     endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic~     colorectal cancer.~   "
133281|NCT01310465|"~     Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone~     mass or low bone mineral density. Among patients with lumbar degenerative disease, some need~     fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the~     rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall~     effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many~     researchers dispute if zoledronic acid can promote the healing of long bone fractures. But~     few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we~     select patients with lumbar degenerative disease who have had lumbar interbody fusion~     surgery. Three days postoperatively, the patients were randomized to either one infusion of~     zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months.~     During this time, we detect bone metabolism and bone fusion of these patients. At last, we~     can tell if zoledronic acid can modify bone metabolism and promote bone fusion.~   "
133282|NCT01310452|"~     Primary objective:~      To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS~     (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of~     treatment with insulin detemir once daily or insulin NPH once daily both with metformin in~     overweight and obese type 2 diabetic subjects.~      Secondary objectives:~      To compare the two treatments with respect to:~        1. Efficacy:~             -  MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous~               Adipose Tissue Ratio.~             -  Change in HbA1c from baseline at 12 and 26 weeks of treatment.~             -  Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.~             -  Weight~             -  Waist and hip circumference~        2. Safety:~             -  Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir~               versus NPH~             -  Lipid profile at the start and after 26 weeks of treatment~             -  Incidence of Adverse events during the trial~             -  Safety profile as measured by laboratory safety parameters (haematology,~               biochemistry) and physical examination/vital signs before and at the end of~               treatment~   "
133283|NCT01310439|"~     The purpose of this study is to examine the neural basis of response inhibition, working~     memory, and sustained attention in adolescents and adults with~     Attention-Deficit/Hyperactivity Disorder (ADHD), with particular emphasis on quantifying the~     effects of methylphenidate (i.e., treatment with psychostimulants) on neural function.~     Participants will undergo electrophysiological measurement of brain function during~     laboratory cognitive tasks. This research is aimed to develop a better understanding of how~     ADHD neural dysfunction relates to clinical presentation and medication response during the~     transition from adolescence to adulthood. The specific aims and hypotheses are:~      Specific Aim: To characterize the effect of Ritalin (methylphenidate) on neural activity~     underlying performance on the response inhibition task in ADHD adolescents and adults.~     Hypothesis 1) Methylphendiate will increase N2 and P3 amplitude in ADHD persons during~     medicated EEG sessions; Hypothesis 2) There will be a significant age × medication~     interaction such that ADHD teens will show increased amplitude of N2 while medicated,~     particularly at frontal sites, whereas ADHD adults will show differentially greater effect~     of medication on P3 amplitude and latency at central sites. Hypothesis 3) Brain activity~     assessed by fMRI will differ between unmedicated and medicated states.~   "
133285|NCT01310413|"~     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate~     vaccine GSK1557484A in children 6 months to < 18 years of age.~   "
133288|NCT01310374|"~     An observational clinical study will be performed in subjects aged 12-60 years old to~     describe the dynamic changes of humoral immune/cellular immunity after vaccination of~     influenza vaccine, and to discuss the role of different antibodies against influenza virus~     infection, and to look for possible factors related to side effects with the vaccine.~   "
133289|NCT01310361|"~     In some studies once daily amoxicillin therapy might be treatment of choice for Group A~     β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment~     with oral penicillin V.~   "
133290|NCT01310348|"~     The aim of this study is to investigate whether there is a relation between bone mineral~     density of lower limbs exposed to vibration and the muscle strength gain in the knee~     extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in~     the knee extensors and flexors in healthy young adult women.~      Forty healthy young adult women are planned to include in this study. The participants~     meeting the criteria were randomized into two groups: the training group (20 cases) and the~     Control group (20 cases).~      The whole-body vibration (WBV) training group will be trained on a WBV platform (Power~     Plate) 5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV~     platform. Training volume and training intensity will be low at the beginning but progressed~     slowly according to the overload principle. The training volume will be increased~     systematically over the 4-week training period. The training intensity will be increased by~     increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects~     will be asked to report negative side effects or adverse reactions in their training diary.~     In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4~     weeks period.~      Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength~     will be measured before and after training period. Isokinetic torque will be measured with~     the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY~     USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and~     muscle strength will be measured before training period. The BMD will be evaluated by bone~     densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human~     sclerostin ELISA kit.~      The rest muscle electrical activity of right and left knee flexor and extensor muscles will~     be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle~     electrical activity will be measured by Powerlab (data acquisition system, ADInstruments,~     Australia) device.~   "
133291|NCT01310335|"~     The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin~     level in healthy young adult women.~      Fifteen healthy young adult women are planned to include in this study. All cases will be~     trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week~     period. Training duration will be short at the beginning but progressed slowly.~      The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz.~     The subjects will be asked to report negative side effects or adverse reactions in their~     training diary.~      Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma~     sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels~     will be measured by human sclerostin ELISA kit.~   "
133292|NCT01310322|"~     A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423~     when administered in different ways.~   "
133293|NCT01310309|"~     The purpose of this two part study is the assessment of the performance of the XIENCE V®~     Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific~     setting of patients with Multi-Vessel Coronary Artery Disease (MVD).~   "
133294|NCT01310296|"~     The purpose of this study is to determine the mass balance and absolute bioavailability of a~     single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of~     lofexidine.~   "
133295|NCT01310283|"~     The goal of this study is to address the effectiveness of a modified cavity prevention~     protocol for 5-9 year-old children which emphasizes better diet modification, more frequent~     professional fluoride applications, and xylitol product usage based on individual risk~     status in a 1-year randomized controlled clinical trial in the University of California, San~     Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize~     that the regimen will help to reduce new cavities in children who are at risk for dental~     cavities.~   "
133296|NCT01310270|"~     The hypothesis being tested is that in patients with stable claudication and documented PAD,~     omega-3 supplementation for 1 month will lead to improvement in endothelial function as~     measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the~     vascular inflammatory profile as measured by a panel of established circulating inflammatory~     biomarkers.~   "
133297|NCT01310257|"~     The aim is to improve understanding of the assessment of pain experience in patients with~     osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study~     1, the investigators will analyse existing questionnaires relevant to the mechanisms and~     therapeutic targets of knee OA to establish discrete dimensions that discriminate between~     the different mechanisms of pain. On the basis of this analysis, the investigators will~     refine the questionnaires to maximise their sensitivity to knee OA. In Study 2, the~     investigators will seek to confirm the factor structure identified in the questionnaires in~     Study 1 and explore potential mediator and moderator variables between pain and quality of~     life using the refined measures. The investigators will also evaluate Quantitative Sensory~     Testing as a predictor of OA knee pain.~   "
133298|NCT01310244|"~     To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with~     Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung~     Cancer (NSCLC).~   "
133299|NCT01310231|"~     The purpose of this study is to determine if the addition of metformin to standard~     chemotherapy improves progression free survival in women with metastatic breast cancer.~   "
133300|NCT01310218|"~     The purpose of the study is to prospectively compare the functional, satisfaction, and wound~     outcomes of patients treated with one of two accepted methods of postoperative dressing~     following carpal tunnel release. Hypothesis: There will be no difference between the short~     term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms~     of outcomes.~   "
133301|NCT01310205|"~     This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited~     to participate in this extension study if they complete treatment in study~     SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV.~   "
133302|NCT01310192|"~     The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine~     (FCH) positron emission tomography (PET) as an imaging technique that can be used to~     delineate malignant tumors in the prostate gland. The proposed technique works by measuring~     the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells~     due to malignant over-expression of the choline transporter and choline kinase enzyme. The~     project scope covers a clinical study to recruit men with prostate cancer who have elected~     treatment by radical prostatectomy surgery. These men will undergo pre-operative PET~     scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging~     results will be compared to histopathologic analyses of the prostatectomy specimen to~     determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.~   "
133303|NCT01310179|"~     This study will test whether it is possible to introduce new genetic material into a small~     portion of a tumor and have the product of the new gene not only kill those tumor cells that~     were infected initially, but also the surrounding tumor cells as well with limited or no~     harm to the patient. The desired effects of this approach are achieved by focusing potent~     chemotherapies directly within the tumor itself and, as a result, avoiding injury to the~     remainder of the body. In this study, we will use two components, the first of which is a~     virus, known as an adenovirus, that has been crippled (i.e., it cannot make more of itself)~     and loaded with a bacterial gene called E. coli purine nucleoside phosphorylase (PNP).~     Adenoviruses are considered to be relatively safe vehicles for gene delivery and are~     presently being used in numerous human trials and therapies worldwide, including a head and~     neck cancer therapy approved for use outside the United States. The loaded adenovirus will~     be used to deliver the PNP gene directly into a tumor in patients. This gene is not expected~     to have an effect itself. However, the gene produces PNP inside the tumor and this protein~     will activate the second component of the therapy, a drug called fludarabine phosphate,~     which is approved by the FDA for certain types of blood-cell cancers, but has not been shown~     to be effective against most solid tumors. The proposed therapy gives the patient several~     infusions of fludarabine following the injection of the virus carrying the PNP gene and, as~     the fludarabine enters the tumor, it will be converted by PNP into a second compound,~     fluoroadenine. Numerous studies in mice and rats have shown that fluoroadenine is a very~     potent anti-cancer agent and that it will kill the tumor cells where it is made as well as~     those in the immediately surrounding area.~   "
133304|NCT01310166|"~     The purpose of this study is to investigate which changes in immunological biomarkers under~     treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be~     detected.~   "
133305|NCT01310153|"~     Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective~     Caesarean birth. There has been no study comparing the efficacy of immediately positioning a~     newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by~     Caesarean birth.~      The investigators hypothesize that when the infant is prone they will have postural~     drainage, better dorsal lung expansion, less vagal response from suctioning and less~     agitation secondary to the righting reflex.~      The investigators will compare 1033 term babies divided by randomization into two groups~     prone and supine. The investigators will check for incidence and severity of Respiratory~     Distress, Use of FiO2 or respiratory support, admissions to NICU.~   "
133306|NCT01310140|"~     Studies have shown that people with certain disorders have an increased risk of developing a~     condition called Metabolic Syndrome (MS). In this study, the investigators want to learn~     more about MS among people staying in the hospital for treatment of Major Depressive~     Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The~     investigators also want to learn more about a stress hormone called cortisol that is made in~     the body. Those who take part in this study will answer some questionnaires, be given some~     psychiatric interviews, and have some blood taken along with a urine sample.~      The investigators believe that patients in the hospital with MDpsy will have higher baseline~     rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance,~     compared with MDD alone.~   "
133307|NCT01310127|"~     This is a single-center, randomized, investigator-masked, parallel group, and~     active-comparator controlled study investigating the clinical outcomes for visual acuity and~     macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or~     Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract~     extraction with posterior chamber intraocular lens implantation.~   "
133308|NCT01310114|"~     The primary objective of the study is to assess the safety and tolerability of Human~     Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control)~     administered intravenously in subjects following ischemic stroke. The secondary objective of~     the study is to assess the effect of PDA001 on improvement in clinical function following~     ischemic stroke.~   "
133309|NCT01310101|"~     The rationale of the study is to explore the safety and efficacy of ofatumumab in~     combination with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL.~     Moreover, the hypothesis is that this approach will be able to achieve at least the same~     response rates compared with R-dex regimens (historical controls; manuscript submitted to~     Leukemia), while maintaining lower toxicity profile.~   "
133310|NCT01310088|"~     The global epidemic of obesity in childhood continues to evolve and threaten future health~     and life expectancy primarily due to the increased incidence of cardiovascular disease.~     Obesity is strongly related to high blood pressure (hypertension) and both conditions pose a~     risk for target organ damage, which can follow a subject from childhood into adult life. The~     AORTA study will investigate central hemodynamics and organ damage in 100 obese children and~     adolescents in order to gain insight to the complex interplay of hypertension, obesity and~     subclinical damage in order to intensify more precise prevention, thereby reducing the~     future development of cardiovascular disease.~   "
133311|NCT01310075|"~     The goal of this clinical research study is to learn if the complication rate and~     post-surgical appearance differ based on what type of mesh is used for breast reconstruction~     surgery.~   "
133312|NCT01310062|"~     More recent studies have shown that the HBV-infected population has a greater risk of~     development of hepatocellular carcinoma. Nevertheless, there are still a significant number~     of people chronically infected by HBV who do not develop the complication. Hence, there~     exist biological markers that could be indicator for the disease-inducing and carcinogenic~     potential of the virus.~   "
133313|NCT01310049|"~     The purpose of this first-in-man trial is to determine the safety and tolerability of~     ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be~     performed in three parts. In Part 1, single doses of LEO 32731 will be administered to~     healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic~     will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy~     male subjects.~   "
133314|NCT01310036|"~     This open-label, single arm study will evaluate the safety and efficacy of Tarceva~     (erlotinib) as first-line therapy in patients with stage IV or recurrent non-small cell lung~     cancer who harbour epidermal growth factor receptor (EGFR) mutations. All patients will~     receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity~     occurs. At the investigator's discretion, patients may receive Tarceva beyond disease~     progression.~   "
133317|NCT01309997|"~     This randomized phase II trial is evaluating how well imatinib mesylate works compared to~     rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host~     disease (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening~     and improve skin and joint flexibility in people with cutaneous sclerosis due to chronic~     GVHD.~   "
133318|NCT01309984|"~     The purpose of this study is to assess the transfer of fospropofol and its active~     metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women~     undergoing a needed procedure.~   "
133319|NCT01309971|"~     The purpose of this study will allow us to observe and follow the subjects' treatment from~     DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.~   "
133320|NCT01309958|"~     This study focused on improving the quality of dental care by fostering movement of the~     latest scientific advances into daily clinical practice.~   "
133321|NCT01309945|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared~     with continued duloxetine in the treatment of patients with treatment resistant depression~     (TRD).~   "
133322|NCT01309932|"~     The purpose of this study is to determine if combination therapy with Pegylated Interferon~     Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or~     BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)~     compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48~     weeks.~   "
133323|NCT01309919|"~     The purpose of the study is to determine the feasibility of placing the~     levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The~     investigators will gain information about complications at the time of placement; the~     investigators will also examine the expulsion rate, side effects, bleeding patterns and~     subject satisfaction at various time periods after insertion.~   "
133324|NCT01309893|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses.~   "
133325|NCT01309880|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lenses developed by Bausch + Lomb.~   "
133326|NCT01309854|"~     The purpose of this study is to investigate the drug interaction between fostamatinib and~     pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone~     when administered alone and with fostamatinib in healthy subjects.~   "
133327|NCT01309841|"~     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of~     opioid-induced constipation in patients with non-cancer-related pain, including those~     patients that have inadequate response to laxative therapy (LIR).~   "
133328|NCT01309828|"~     The purpose of this study is to evaluate long term safety and tolerability of azilsartan~     medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and~     hydrochlorothiazide in hypertensive participants with moderate renal impairment.~   "
133329|NCT01309815|"~     The purpose is to describe, interpret and provide a detailed understanding of what it means~     to be elderly people with cancer who receive treatment in specialized health care. Focus is~     especially put on the content and expression of existential issues and the importance of~     spirituality for the patient´s life story and medical story.~   "
133330|NCT01309802|"~     Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is~     extremely challenging. Published reports and our previous work support our hypothesis that~     symptomatic patients experience relief of pain and healing of ulcerations with minimal~     adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's~     phenomenon. The proposed study is the first clinical trial and prospective study designed to~     document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with~     Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection~     relieves pain associated with Raynaud's disease for longer than 28 days, improving patients'~     quality of life. Through this study we intend to further determine the effect of injected~     Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing~     the patients for whom this treatment is most effective.~   "
133331|NCT01309789|"~     The purpose of this study is to assess the safety profile of brentuximab vedotin~     sequentially and in combination with multi-agent chemotherapy in front-line treatment for~     CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell~     lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to~     define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in~     sequence and in combination with multi-agent front-line chemotherapy.~   "
133332|NCT01309776|"~     The primary object of this study is to confirm the superiority of tianeptine compared to~     escitalopram on effects that improves subjective and objective cognitive impairments in~     patients suffering from major depressive disorder.~   "
133333|NCT01309763|"~     This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I~     pilot study to assess tolerability and safety of repeated subcutaneous administration of a~     single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to~     moderate Alzheimer's disease.~   "
133334|NCT01309750|"~     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in~     patients after recent antibiotic use. The current standard of care treatment for severe C.~     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is~     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,~     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted~     mortality rate is 14% for severe infection. It is believed that the failure of treatment may~     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral~     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin~     functions by direct contact with the colon. It is presumed that this paralysis of the small~     intestine is present but has never been proven. The objective of the study is to prove that~     there is an adynamic ileus present in c. diff colitis and therefore lead to investigations~     into improved treatment.~   "
133335|NCT01309737|"~     The main objective of this study is to compare the effects of CP-690,550 with the effects of~     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This~     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.~   "
133336|NCT01309724|"~     Inadequate identification of and subsequent delayed therapy for patients with hypoperfusion~     (including hypovolemia, congestive heart failure and sepsis) is a common problem faced by~     physicians and intensivists caring for critically ill patients. Bedside clinical assessment~     is notoriously inaccurate in diagnosing complex etiologies of hemodynamic disturbances and~     in deciding on the appropriate therapy. Invasive techniques which are often required to~     guide diagnosis and therapy have significant risks associated with them, are costly, and are~     time consuming. New technology has been developed that allows for instantaneous, noninvasive~     monitoring of key hemodynamic parameters, like stroke volume, peak velocity and cardiac~     output. This new technology has the potential to improve recognition of the etiology of~     hemodynamic disturbances and assist the clinician in optimizing therapy based on changes in~     hemodynamic parameters. There is significant potential for this to be translated into~     improved outcomes in critically ill patients, but this has never been studied.~   "
133337|NCT01309711|"~     N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance~     spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with~     cerebral hypoxia-ischaemia. The MRS lactate (Lac)/NAA peak-area ratio increases during and~     after severe cerebral hypoxia-ischaemia reflecting mitochondrial injury and impaired~     oxidative phosphorylation.~      Aims: (1) To establish normative ranges for thalamic 1H MRS NAA concentration and Lac/NAA in~     healthy newborn infants (2) To examine the accuracies of thalamic 1H MRS NAA concentration~     and Lac/NAA for predicting adverse neurodevelopmental outcome in neonatal encephalopathy~     (NE)~      Design: Prospective observational study Methods: Year 1: Following 1H MRS methodology~     optimisation 40 healthy control infants will be recruited to collect normative data. Year 2~     to 3: 115 infants with NE, undergoing therapeutic hypothermia will be recruited. MRS will be~     performed aged less than 4 days and 7 to 14 days and thalamic NAA levels and Lac/NAA will be~     quantified; Qualitative interviews to evaluate parental understanding of this biomarker.~     Year 4, 5: Outcome assessment by BSID III at 18 months.~      Outcomes: Mean thalamic NAA levels and Lac/NAA and appropriate confidence intervals in~     normal infants, and thalamic NAA levels and Lac/NAA in infants with NE according to~     neurodevelopmental outcome. Areas under curves for thalamic NAA and Lac/NAA will be examined~     separately for early & late MRS. Accuracy of early MRS will inform utility of this~     investigation in decisions about withdrawal of life support; late MRS will inform about~     efficacy as a surrogate end point in clinical trials. Qualitative interviews will be~     thematically analysed and reported.~   "
133338|NCT01309698|"~     This study will evaluate the effect of voglibose on the pharmacokinetics and~     pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.~   "
133339|NCT01309685|"~     Background:~      - Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration~     (FDA) to help people stop smoking. Varenicline is very effective in helping some people quit~     smoking, but is less effective for others. Researchers are interested in conducting more~     in-depth studies into how varenicline works, including its effect on smokers' responses to~     items that may trigger cigarette cravings, in order to develop better smoking cessation~     medications.~      Objectives:~      - To examine the effectiveness of varenicline as an effective medication for tobacco~     addiction by studying its effect on nicotine reinforcement, nicotine-seeking behavior,~     cue-elicited craving, and performance impairment and craving after overnight tobacco~     deprivation.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been smoking at least 10 cigarettes~     per day for at least 2 years.~      Design:~        -  This study will require 12 study visits. Some visits will be brief and other visits~          that involve test sessions will last up to 8 hours. If no sessions are repeated, the~          study will take 26 days. Participants will not be required to attempt to quit smoking~          during this study.~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine tests, and other tests as required by the study researchers.~        -  Participants will take two sets of pills during the study: the first set during the~          first 12 days of the study, followed by a 2-day break, then the second set during the~          last 12 days. Some of the pills will contain varenicline, and others will be placebos.~        -  On Day 1 of the study, participants will come to the National Institute on Drug Abuse~          to receive the first set of pills. Participants will take the first pill before~          leaving.~        -  On Day 8, participants will have a training session that will measure the amount of~          carbon monoxide in the breath. Participants will also complete several questionnaires~          about smoking habits and current mood, and will have a chance to practice the~          procedures they will do in the study.~        -  On Days 9 and 10, participants will have behavioral test sessions that will last 7 to 8~          hours. Day 9 will involve tests of cue response to items that may trigger cigarette~          cravings, and tests of general nicotine cravings over several hours. Day 10 will~          involve tests of general nicotine cravings over several hours, and then tests of~          nicotine-seeking behavior. Participants will be provided with lunch during these~          all-day sessions.~        -  On Day 11, participants will have memory and attention tests, and will provide a blood~          sample. Participants will not be allowed to smoke for 12 hours before the start of the~          next test on Day 12.~        -  On Day 12, participants will provide a breath sample, and will have two sets of memory~          and attention tests before they will be permitted to start smoking again. There will be~          no tests on Days 13 and 14.~        -  Starting on Day 15, participants will repeat the schedule of tests from Days 1 through~          12 with the second set of pills.~   "
133340|NCT01309672|"~     RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such~     as abiraterone acetate, may lessen the amount of androgens made by the body. It may also~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate~     works in treating patients with prostate cancer who have undergone initial hormone therapy.~   "
133341|NCT01309659|"~     The purpose of this study is to determine whether treatment of unexplained anemia in older~     adults with a short course of weekly intravenous iron infusions can improve physical~     activity and therefore quality of life.~   "
133342|NCT01309646|"~     This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib~     vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4~     and 6 months of age.~   "
133343|NCT01309633|"~     Aims:~      Primary objectives~        -  To determine the pathological complete response (CR)* rate of intermittent sunitinib~          administered with combination cisplatin and gemcitabine as systemic therapy for locally~          advanced or systemic NPC.~        -  To determine the safety and tolerability of intermittent sunitinib administered with~          combination cisplatin and gemcitabine as systemic therapy for locally advanced or~          systemic NPC.~      Secondary objectives~        -  To determine the clinical response rate (RR; complete and partial response)+ of~          intermittent sunitinib administered with combination cisplatin and gemcitabine as~          systemic therapy for locally advanced or systemic NPC.~        -  To evaluate the pharmacodynamic effects (imaging, circulating and tissue) of~          intermittent sunitinib administered with combination cisplatin and gemcitabine as~          systemic therapy for locally advanced or systemic NPC.~        -  To compare the early pharmacodynamic effects (imaging, circulating and tissue) of a~          loading dose of 12.5mg or 25mg sunitinib for 7 prior to administration of systemic~          cisplatin and gemcitabine chemotherapy.~   "
133344|NCT01309620|"~     Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in~     type 2 diabetics~   "
133410|NCT01308749|"~     The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental~     treatment for improving social difficulties in individuals with autism.~   "
133345|NCT01309607|"~     The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and~     carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic~     erbB2-positive breast cancer.~      Secondary objectives include:~        -  To determine the safety and tolerability of weekly paclitaxel and carboplatin, combined~          with lapatinib, in an Asian population~        -  To determine breast conservation rates following neoadjuvant paclitaxel/ carboplatin/~          lapatinib~        -  To determine clinical response rates and relapse-free survival of patients treated with~          neoadjuvant paclitaxel/ carboplatin/ lapatinib~        -  To identify predictive tumour biomarkers for pathologic complete response~      The investigators hypothesize that pathologic complete response rates will be improved from~     15% to 35% with the neoadjuvant regimen of carboplatin/ paclitaxel/ lapatinib compared to~     standard chemotherapy alone in HER2 positive early stage breast cancers.~   "
133346|NCT01309594|"~     An international investigation to evaluate if, and if so how long, autologous bone marrow~     hematopoietic stem cell transplantation can safely restore liver functions for HIV infected~     patients who have decompensated liver cirrhosis.~   "
133347|NCT01309581|"~     The primary objectives of this study are to investigate the potential for ketamine~     anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to~     decrease acute ECT-induced adverse cognitive effects.~   "
133348|NCT01309568|"~     The objective of this study is to demonstrate the clinical performance of the Quidel Reader~     Influenza A+B test and Quidel Reader with the following sample types: nasal swab,~     nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on~     comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or~     Alternative Laboratory.~   "
133349|NCT01309555|"~     This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
133350|NCT01309542|"~     The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR)~     during open-label treatment in adult outpatients who had a primary diagnosis of major~     depressive disorder (MDD). The study also evaluated the long-term response of subjects~     receiving DVS SR for clinical global evaluation, functionality, general well-being, pain,~     and absence of depressive symptoms (remission).~   "
133351|NCT01309529|"~     Current standard of practice in study institution dictates day of surgery urinary catheter~     removal in general thoracic surgery patients receiving thoracic epidural analgesia. The~     investigators hypothesize that this practice results in low recatheterization rates~     secondary to urinary retention and low urinary tract infection rates.~   "
133352|NCT01309516|"~     The study aims to:~        1. Develop a culturally appropriate psychosocial intervention~        2. Test feasibility and acceptability of psychosocial intervention in women suffering from~          postnatal depression.~      Primary Hypothesis:~      Depressed mothers who will receive the group intervention will show significant improvements~     in terms of symptoms of depression.~      Design:~      Randomised controlled trial.~      Setting:~      Outpatient department of Civil hospital Karachi.~      Participants:~      A total of 84 depressed mothers will be randomised equally to an intervention group and a~     Treatment as usual control group.~      Interventions:~      The 12 session multimodal psychosocial intervention will be delivered to mothers in the~     intervention group over a three months period. Each session would take up to 45 minutes.~     Control group will receive standard postnatal follow-up.~      Outcome measures:~      Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale~     (EPDS)and Hamilton Depression Rating Scale (HDRS).~   "
133353|NCT01309503|"~     The main purpose of the study is to estimate speech intelligibility in noise. A Norwegian~     Hearing in Noise Test (HINT) for children will be implemented, and test results for normal~     hearing (NH) children and adults will be collected. Test results for groups of hearing aid~     (HA) users and test results for cochlea implant (CI) users will be collected and compared to~     the NH group and between groups of HA users and CI users. A group of single sided hearing~     loss patients will also be included. Binaural benefits of two ears, two HAs and two CIs will~     be estimated.~   "
133354|NCT01309490|"~     The purpose of this study is to learn whether oral Ribavirin is safe and effective in~     treating patients with solid tumour cancers, that have high levels of the protein eIF4E.~   "
133355|NCT01309477|"~     It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).~   "
133356|NCT01309451|"~     The investigators hypothesize that a combination treatment with Avastin and Ozurdex will~     result in a more rapid improvement of visual acuity compared to the use of Avastin alone.~   "
133357|NCT01309438|"~     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of~     rivaroxaban when administered with erythromycin to study participants with mild or moderate~     renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban~     administered to study participants with normal renal function.~   "
133358|NCT01309425|"~     The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of~     tapentadol (CG5503) in healthy Japanese and Korean adult male participants.~   "
133359|NCT01309412|"~     The purpose of this study is to assess the safety and the tolerability of siltuximab up to~     11.0 mg/kg in combination with bortezomib and dexamethasone for patients with relapsed or~     refractory multiple myeloma.~   "
133360|NCT01309399|"~     Teriparatide is a potent osteoporosis medication that helps prevent fractures, however, the~     investigators know little about its effect on the hip. The investigators will evaluate hip~     bone samples from patients treated with teriparatide before undergoing hip replacement. The~     information will help us understand how teriparatide might help reduce hip fracture risk.~   "
133361|NCT01309386|"~     The purpose of this study is to evaluate the conversion rate based on the number of~     participants achieving pain control and safety within 1 week after switching the opioid~     (morphine-like medications) analgesics (drug used to control pain), when tapentadol~     extended-release (ER) (JNS024ER) is orally administered to participants treated with~     around-the-clock opioid analgesics, for their moderate to severe (very serious, life~     threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a~     specific area) cancer (abnormal tissue that grows and spreads in the body) pain.~   "
133362|NCT01309373|"~     The purpose of this study is to estimate the level of symptomatic and psychosocial remission~     of patients with schizophrenia and schizoaffective disorder in standard clinical practice as~     a function of the degree of adherence to antipsychotic treatment. The secondary objectives~     are to study the level of community integration of the patients included in the study, and~     its influencing factors, to analyze the role of various sociodemographic factors, factors~     related to the course of disease and the psychopathological status of the patient in~     community integration and remission, to analyze the potential predictors of a favorable~     course (symptomatic and psychosocial remission) and a poor course (no symptomatic or~     psychosocial remission), to assess the impact of treatment adherence on the change in the~     functional and community integration status of patients (based on the occupation,~     independence level, and degree of disability variables), to assess the significance of~     premorbid (academic and social) adjustment in the symptomatic and functional remission and~     the community integration status of patients and to correlate the level of insight to the~     remission and integration status of patients.~   "
133363|NCT01309360|"~     Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary~     plexus anesthesia have any effect on the success rate and additional parameters of block~     quality? Methodology: In this prospective cohort study three groups of 40 outpatients each~     were administered dosages of 1% prilocaine of either 40mL, 30mL or 20mL for axillary plexus~     anesthesia. Met-Hb was measured prior to administration of the block and then hourly until~     the Met-Hb concentration fell. Parameters of block quality and any adverse effects were~     recorded. The level of significance was defined with α ≤ 0.05.~   "
133364|NCT01309347|"~     The purpose of this study is obtain prosthetist's feedback on the novel conformable socket~     material developed by Infoscitex, and determine if it is a viable alternative to current~     prosthetic socket liners. During this task, the research team will travel to the~     prosthetists locations to have them evaluate the socket system by examining the material and~     providing their professional opinions and feedback with regard to comfort and fit for the~     amputee, its ease of use, and breathability.~   "
133365|NCT01309334|"~     Multicenter open-label prospective comparative study of PET-scan and MRI at the time of~     diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.~   "
133366|NCT01309321|"~     The purpose of this study is to determine if an intensive handwashing intervention~     administered to primiparous women during their pregnancy can increase maternal handwashing~     with soap at critical times.~   "
133367|NCT01309308|"~     Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to~     delivery.~   "
133368|NCT01309295|"~     This prospective observational study will assess the efficacy and safety of Mircera (methoxy~     polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney~     disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each~     patient will be collected over 12 months of treatment.~   "
133369|NCT01309282|"~     This observational study will assess the long-term efficacy and safety of MabThera/Rituxan~     in routine clinical practice in patients with sero-positive rheumatoid arthritis who are~     non-responders or intolerant to a single tumour necrosis factor (TNF) inhibitor. Data will~     be collected from each patient over 2 years.~   "
133370|NCT01309269|"~     This observational study will assess the effect of long-term treatment with Mircera (methoxy~     polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data~     will be collected from each patient for at least 24 months.~   "
133371|NCT01309256|"~     Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical~     robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many~     studies have reported successful outcomes for robotic surgery, there is no multicenter~     prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this~     study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the~     learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in~     comparison with laparoscopic gastrectomy.~   "
133372|NCT01309243|"~     The purpose of the study was to evaluate the safety and efficacy of the emtricitabine~     (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR)~     compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not~     previously received treatment with antiretroviral medications.~      Participants were randomized in a 1:1 ratio to receive one of the study treatments.~     Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL)~     at screening. A treatment duration of 96 weeks was planned, with the option for subjects in~     FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR~     is commercially available or until Gilead Sciences elects to terminate development in that~     country.~   "
133373|NCT01309230|"~     This is a Phase II open-label trial of maintenance Vigil™ autologous tumor cell vaccine.~     Tumor will be harvested at the time of surgical debulking (standard of medical care).~     Subsequently, patients achieving clinical CR following primary surgical debulking and~     doublet chemotherapy will be stratified for i) surgical stage (Stage IV or suboptimal~     debulking (>1 cm residual) Stage III disease versus Stage III patients with optimal~     debulking (<1 cm residual)) and ii) post-op chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL~     versus 0≤10 U/ml. (Note: patients with Stage IIIc ovarian cancer will be additionally~     evaluated as a subset using descriptive statistics only). Patients will receive 1.0 x 10^7~     cells / intradermal injection of gene transfected autologous tumor cells, Vigil™ once a~     month for up to 12 doses as long as sufficient material is available. Enough harvested~     tissue to provide a minimum of 4 monthly injections will be required for entry into the~     study. Hematologic function, liver enzymes, renal function and electrolytes will be~     monitored monthly. Immune function analysis including ELISPOT analysis of cytotoxic T cell~     function to autologous tumor antigens will be monitored at (≤24 hours before) tissue~     harvest, ≤24 hours before the first cycle of chemotherapy (post debulking), ≤24 hours before~     the third cycle of chemotherapy (post debulking), baseline (screening), prior to Vigil™~     injection Months 2, 4, 6 and at EOT. The dates of the last dose of chemotherapy and the~     administration of Vigil™ vaccine #1 will be recorded. Treatment will be continued until~     disease recurrence or exhaustion of the patient's vaccine supply. If ≥ Grade 2 toxicity by~     NCI Common Toxicity Criteria (excluding Grade 2 fever ≤ 24 hours and Grade 2 and 3 injection~     site reactions) develops related to study treatment the vaccine dose will be reduced by 50%~     and continued on a monthly basis. If a single patient develops ≥ Grade 3 toxicity (other~     than injection site reaction) related to study treatment the trial will be placed on hold~     for reevaluation of design in discussion with FDA. During this hold, no new subjects will~     initiate dosing, but subjects already being dosed may continue dosing as scheduled if deemed~     clinically appropriate by the PI.~   "
133374|NCT01309217|"~     Nurse-administered smoking cessation interventions have been shown to be efficacious, but~     are seldom implemented due to lack of training and time. This project aims to disseminate~     and test the nurse-administered Tobacco Tactics intervention in 6 hospitals.~   "
133377|NCT01309178|"~     Cystic fibrosis patients suffer from a chronic destruction of the lung, frequent and finally~     chronic pneumonia and a reduced life expectancy. Unfortunately, no curative treatment for~     cystic fibrosis is available, neither are treatments established that prevent the disease.~     Our data identify ceramide as a potential novel target to treat cystic fibrosis.~      Two smaller trials support the notion that inhibition of the acid sphingomyelinase by~     amitriptyline improves the lung function of CF-patients even at a dose that is low enough to~     avoid adverse effects.~      In the present proposal the investigators, therefore, aim to test in a larger cystic~     fibrosis patient population whether an inhibition of ceramide release in the lung caused by~     the lack of functional CFTR improves the lung function of cystic fibrosis patients.~     Inhibition of ceramide-release in the lung will be achieved by treatment with amitriptyline,~     which is used as an anti-depressant drug for almost 50 years. Although it is not absolutely~     specific, it seems to be relatively specific for the degradation of acid sphingomyelinase~     (typically 60-80% of cellular acid sphingomyelinase are degraded), which releases ceramide~     from sphingomyelin.~      If the data confirm the beneficial effect of amitriptyline already observed in our~     preliminary studies, the present clinical study may establish a novel treatment to improve~     clinical symptoms of cystic fibrosis and, moreover, to prevent or at least delay the onset~     of cystic fibrosis.~      Hypothesis~        -  Amitriptyline reduces ceramide concentrations in respiratory epithelial cells (measured~          in nasal epithelial cells obtained by brushing nasal mucosa).~        -  Amitriptyline treatment reduces cell death in bronchi and deposition of DNA on the~          respiratory epithelium, which permits elimination of P. aeruginosa from the lung~          (measured as P. aeruginosa counts in tracheal fluid).~        -  Amitriptyline treatment results in normalization of the function of leukocytes (number~          determined in serum and tracheal fluid)~        -  Amitriptyline reduces systemic and local inflammation (measured as cytokines in plasma~          and tracheal fluid).~      Based on these effects amitriptyline increases the lung function of cystic fibrosis patients~     (measured by FEV1).~   "
133378|NCT01309165|"~     Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown~     promise in improving stroke recovery components such as basic mobility and activities of~     daily living; however, evidence suggests these improvements are not generalized and~     transferred to home, community, or work settings, and usually do not impact overall~     participation outcomes. Further, these treatments are very intense, with total treatment~     times as high as 30 to 60 hours, making them clinically or economically unfeasible in many~     settings. In contrast, approaches incorporating cognitive strategy training have shown great~     promise to not only improve functional activity performance in people living with stroke,~     but also to facilitate generalization and transfer beyond the clinical setting, and to do so~     in 10 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP)~     is an established treatment approach that uses cognitive strategies in combination with TST.~     Evidence from other research groups and findings from our own participant interview data~     indicate that the approach may be even more effective if introduced much earlier in the~     rehabilitation process, however, CO-OP has not yet been tested in this sub-acute population.~     Therefore, the specific project goals are: 1. To refine the CO-OP treatment approach for use~     with people less than three months post stroke; 2. To evaluate, in a Phase II clinical~     trial, the preliminary efficacy of the refined protocol compared to standard occupational~     therapy on immediate and longer-term skill performance and participation; 3. To determine~     effect sizes for power calculations for a future Phase III clinical trial to test the new~     protocol versus contemporary treatment. The research approach consists of Part 1, Protocol~     Refinement, and Part 2, Exploratory Phase II Clinical Trial.~   "
133379|NCT01309152|"~     The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is~     reduced in morbidly obese patients. The primary objective of this exploratory pilot study is~     therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin~     in morbidly obese patients and non-obese patients. The investigators aim to examine whether~     and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin~     concentrations. Possible factors of influence on the distribution of cefazolin (tissue~     perfusion, body weight, distribution of adipose tissue, other) will be identified.~   "
133380|NCT01309139|"~     The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after~     treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of~     tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with~     the systemic exposure following inhalation of the free combination (Treatment B) of~     tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when~     administered once-daily over 21 days via Respimat(R) (RMT).~      The secondary objectives are:~      to compare the systemic exposure to tiotropium and CD 1857 after single dose administration~     of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure~     to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of~     the free combination of tiotropium/BI 54903 to compare the safety and tolerability of~     tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively~   "
133381|NCT01309126|"~     Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified~     subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio~     to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be~     dosed until progression or discontinuation for some other reason. Efficacy will be assessed~     via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT)~     scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and~     biomarker parameters will also be assessed.~   "
133382|NCT01309113|"~     Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180~     patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to~     achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150~     are expected to complete the study per protocol.~      Study objectives:~      Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for~     treatment of cyclic mastodynia and premenstrual syndrome.~      To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic~     mastodynia.~      Dose regimen:~      Group 1: VAC BNO 1095 1x10 mg:~      1 tablet of verum in the morning, 1 placebo tablet in the evening~      Group 2: VAC BNO 1095 2x10 mg:~      1 tablet of verum in the morning, 1 tablet of verum in the evening~      Group 3: Placebo:~      1 tablet placebo in the morning, 1 tablet placebo in the evening~      The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After~     first screening further visits are scheduled after the end of each of the first and second~     run-in cycle, and after the first, second and third treatment cycle, respectively.~      Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of~     menstruation number n, with exception of the first screening visit which can be performed at~     any time prior to the first run-in cycle. Subsequently the time between the first study~     visit and the onset of the first run-in cycle menses T shall be added to the overall study~     duration.~      In case that the next menstruation does not commence as expected, the patient should contact~     her investigator immediately in order to schedule a new appointment, approximately on the~     actual day 3 of the menses.~   "
133383|NCT01309100|"~     The objective of this study is to determine the clinical feasibility and to evaluate the~     product performance of investigational contact lens.~   "
133384|NCT01309087|"~     The primary objective of this study is to substantiate prediction accuracy(with a tighter~     95% confidence interval compared to current diagnostic modalities), of a lung cancer~     biomarker for risk stratification of patients into high and low risk categories to aid in~     clinical evaluation of the patient.~   "
133387|NCT01309048|"~     This study is to confirm the safety and technical of MRI guided High Intensity Focused~     Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.~      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate~     tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.~     The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be~     performed in patients who pass inclusion/exclusion criteria.~   "
133388|NCT01309035|"~     Introduction:~      Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of~     these knee replacements are performed with the use of bone cement. Traditionally, a~     tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to~     perform delicate dissections in a bloodless operative field.~      A tourniquet can be defined as a constricting or compressing device used to control~     temporarily venous and arterial circulation to an extremity. Pressure is applied~     circumferentially on the skin and underlying tissues of a limb. This pressure is transferred~     to the walls of vessels, causing them to become occluded.~      It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a~     number of disadvantages, for instance, severe pain and muscle effects during the first~     postoperative day, thereby slowing rehabilitation.~      Other side effects related to tourniquet use, include pulmonary embolus caused by venous~     thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque.~     Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide~     spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome,~     post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the~     quality of binding between bone and cement and thereby fixation of the knee prosthesis?~     Since the introduction of modern cementing techniques, no previous clinical studies have~     investigated the advantages or disadvantages of tourniquet use in knee replacement surgery.~      Aims/hypothesis of the study:~        1. To investigate the advantages and disadvantages of tourniquet use, including whether~          not using a tourniquet reduces pain, facilitates mobilisation and recovery, and~          shortens length of stay.~        2. To study whether use of a tourniquet affects leg muscles during and after surgery, as~          measured by with use of microdialysis to quantify level of ischemia .~        3. To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet~          use. Because third generation cements secure prosthesis fixation, the investigators do~          not expect to find any clinically significant migration (less than 2 mm) 2 years after~          surgery.~      Perspectives:~      The investigators hope that the results of our study will improve rehabilitation regimes so~     that patients will experience less pain after surgery and thus achieve more rapid~     mobilisation and return to their daily lives.~   "
133389|NCT01309022|"~     The purpose of this protocol is to provide continued acess to immunosuppressive medications~     to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES~     NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.~   "
133390|NCT01309009|"~     This phase IIa study is designed as a multi-centre, single country, randomised,~     double-blind, placebo controlled study in three parallel groups, with the aim to evaluate~     the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in~     comparison to placebo in the treatment of infantile colic.~   "
133391|NCT01308996|"~     The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to~     autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental~     implants.~   "
133392|NCT01308983|"~     Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of~     young adults with prehypertension.~   "
133393|NCT01308970|"~     The purpose of this study is to determine if participation in one of three different health~     management groups will elicit genomic and biochemical changes and decrease perceived stress~     levels and symptoms in healthy, stressed adults. The investigators expect that changes in~     self-reported psychological stress and symptoms will be directly linked to changes in~     biological indicators (genomic expression profiles and neuroendocrine and pro-inflammatory~     biomarkers).~   "
133394|NCT01308957|"~     The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on~     changes in muscle mass, muscular strength and physical function.~   "
133395|NCT01308944|"~     This research is looking at the effect of biobehavioral factors such as stress and whether~     these factors alter how the body responds to chemotherapy, one of the purposes of this study~     is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable~     when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or~     primary peritoneal cancer. An additional purpose of the study is to understand if behavioral~     factors such as depression and anxiety can alter different blood markers that affect tumor~     vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such~     as Inderal, might alter these behavioral factors by drawing blood prior to and after the~     administration of Inderal as well as giving behavioral questionaires at different time~     points. Beta-blockers are commonly used for the treatment of hypertension, protection of the~     heart after a heart attack, and irregularities in heartbeats. Altering these factors might~     boost the immune system and affect other areas of cancer biology, thereby allowing the~     chemotherapy to be more effective. The significance of this research is that it may help~     improve our treatments of this disease in the future.~   "
133396|NCT01308931|"~     Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve. In~     prior studies, tubal ligation has been shown to have an adverse effect on ovarian reserve.~     One theory postulated for this effect is that the ovarian circulation is disrupted by the~     procedure, leading to altered hormone production. In this prospective cohort study, the~     investigators plan to analyze the rates of AMH decline by comparing the following~     contraceptive methods: tubal ligation, Essure placement, and levonorgestrel intrauterine~     devices (IUDs).~   "
133397|NCT01308918|"~     Thoracic surgeries usually require lung isolation techniques. Double-lumen tube (DLT),~     either right or left sided, is the most frequent tool used to realize this technique. In~     front of difficult airways, the use of videolaryngoscopy (GllideScope®) (GS) may~     advantageous. Hypothesis: We will test the hypothesis that under GS, the use of a specific~     semi-rigid stylet is efficacious to insert a DLT, and also safe. The increased rigidity of~     the GlideRite DLT Stylet for double-lumen tubes will enable the DLT to keep its form while~     it is railroaded into superior airways. This new stylet combined to Glidescope® utilization~     will increase the rate of successful intubation, especially in patients with difficult~     airways. This technique will allow us to directly intubate with a DLT using the GlideScope®,~     avoiding a beforehand SLT intubation and airway exchange catheter use. Consequently, its use~     could reduce risks associated to blind insertion of DLT with airway exchange catheter~     (airway traumatism and pulmonary aspiration). Primary objective: To determine the GlideRite~     DLT Stylet efficiency for double-lumen tubes orotracheal intubation under videolaryngoscopy~     (GllideScope®). Secondary objectives: to time successful intubation, to count the number of~     intubation attempt, to verify the influence of difficult intubation score (DIS) on~     successful intubation, and to log complications associated to its use. Exclusion criterion~     are: previous history of difficult intubation, anticipated difficult mask ventilation, and~     anticipated difficult intubation. Conclusion: The aim of using the GlideRite DLT Stylet for~     an orotracheal intubation under videolaryngoscopy is to allow the primary intubation with a~     DLT in patients with abnormal superior airways. These anomalies are more and more frequent.~     Alternative airway management implies more manipulations, leading to an increased risk of~     oxygen desaturation, lung aspiration, and airway lesions. Moreover, these alternatives take~     more time than using a Glidescope, which can be compare to direct laryngoscopy. The~     development of a semi-rigid stylet, such as the GlideRite DLT Stylet, is a great advancement~     in the management of primary intubation with DLT, mainly in face of difficult airways.~   "
133398|NCT01308905|"~     The purpose of this study is to gain knowledge about how to best diagnose and treat tumors,~     how tumors affect normal tissue and how treatment of tumors with radiation therapy and~     chemotherapy affect tumors.~   "
133399|NCT01308892|"~     In the CHOC study the investigators will examine the effect of chocolate flavanols on~     vascular function, inflammation, oxidative stress and markers of endothelial function. The~     effects of both acute consumption and prolonged consumption will be studied. The secondary~     objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will~     improve the response to a high fat/high energy challenge.~   "
133400|NCT01308879|"~     The purpose of this clinical trial was to test the hypothesis that clients of clinicians who~     were scheduled to receive weekly feedback on their clients' progress would improve faster~     than clients of clinicians who were not scheduled to receive weekly feedback.~   "
133401|NCT01308866|"~     BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging~     lifestyles might change the trend. The aim of this study is to assess if~     hypercholesterolemic patient involvement in the preventive decision with the help of a~     decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.~      METHOD: The design is a cluster randomised clinical trial. Participants are~     hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of~     Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are~     excluded. It is expected to create two cohorts of 139 patients each one. The randomisation~     is by doctor. Intervention group will receive information about their CV risk and the risk~     and benefits of different preventive measures. They will have access to a decission aid that~     will help them in the choice of the preventive measures.The material (printed and software)~     is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE~     and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors,~     subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls,~     treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12~     month assessment. The study, financed by FIS, will begin the 01-07-2007.~      RESULTS: The expected results are a higher reduction on the CV risk factors in the~     intervention group versus regular care.~      CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.~   "
133402|NCT01308853|"~     The study evaluates treatment procedure, efficacy and safety of NASHA BE for female breast~     enhancement.~   "
133403|NCT01308840|"~     The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in~     KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have~     previously not received chemotherapy. This study will also examine the potential toxicities,~     progression-free and overall survival in this population.~   "
133404|NCT01308827|"~     Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal~     meningitis among infants and children worldwide. Knowledge of the epidemiology of~     pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease~     usefulness of pneumococcal conjugate immunization. There is a paucity of information~     regarding pneumococcal disease burden in children in Latin America. Most studies are based~     on passive microbiology laboratory surveillance that does not capture all invasive disease,~     thus underestimating the true disease burden. Data from an active surveillance is available~     from an specific region in Costa Rica, before introduction of universal vaccination with~     PCV-7. On January 2009, PCV-7 was introduce into the universal vaccination program for all~     children born after or on September 2008 using a 3+1 regimen therefore there is a~     possibility to analyze the benefits of the introduction of this vaccine into the universal~     immunization program. The only effectiveness data from Latin America have been published~     from Uruguay where a significant decline in the incidence of pneumonias and meningitis was~     observed following the introduction of PCV-7. This was associated with an increment of~     serotypes 19A, 1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011,~     PCV-7 was changed for PCV 13. This study will provide information regarding the impact of~     PCV-7 and PCV-13.~   "
133405|NCT01308814|"~     Study Background and Objectives: In the U.S. the majority of heart disease deaths are in~     women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in~     women after the menopause. Depression has been associated with an increased risk for CVD~     morbidity and mortality. Even histories of recurrent depression in euthymic individuals are~     associated with elevated CV risk. Understanding the depression-CVD link may have particular~     relevance for women since women experience depression at a rate twice that of men.~     Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one~     likely mechanism contributing to both CVD and depression in women. The perimenopause, a time~     associated with a two-fold increase in rates of depression, may provide an ideal opportunity~     for studying the pathophysiology of CV risk and depression in women.~      The primary objective of this study is to examine the prophylactic role of estradiol in the~     development of depressive symptoms and the progression of cardiovascular risk in~     perimenopausal women with or without histories of depression. The investigators predict that~     women susceptible to depression will be particularly vulnerable to the acceleration of CVD~     in the context of the perimenopause and, consequently, will show differentially greater~     benefit of estradiol treatment during the menopause transition for both indices of CV risk~     (e.g. inflammation, endothelial function, stress reactivity), as well as depressive~     symptoms.~   "
133406|NCT01308801|"~     The purpose of this study is to determine the analgesic effectiveness of Repetitive~     Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation~     exercises in patient suffering from fibromyalgia.~      A double blind clinical trial with two randomized parallel groups:~        -  Placebo rTMS and rehabilitation exercise~        -  Active rTMS and rehabilitation exercise~   "
133407|NCT01308788|"~     The purpose of this study will be to compare the aqueous production suppressant to aqueous~     outflow drugs in terms of the response to known vascular parameters. Specifically; systemic~     perfusion pressure, retrobulbar blood flow and retinal microcirculation.~   "
133408|NCT01308775|"~     This is a pilot study that will compare two systems of breast cancer follow up care and will~     evaluate a number of parameters indicating quality and efficiency of care delivery as well~     as patient satisfaction with care. Approximately 100 breast cancer patients who have~     completed the acute phase of treatment will be randomized to one of two follow up care~     plans.~   "
133409|NCT01308762|"~     To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed~     Mycobacterium obuense) in melanoma cancer patients.~   "
133411|NCT01308736|"~     The investigators will randomize smokers to receive 1) Varenicline + smoking~     cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling.~     Neither the participants nor the research therapists/evaluators will know to which condition~     (active or placebo pill) the participants have been assigned i.e., a double-blind study).~     The medication and weekly counseling will occur for 28 days. Participants will complete~     assessment measures just before the start of treatment (baseline), at the end-of-treatment,~     at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use~     between treatment groups.~   "
133412|NCT01308723|"~     This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in~     combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma~     previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients~     will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination~     with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be~     randomized to receive either the previously established dose of RO5323441 iv every 2 weeks~     plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is~     until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm~     with disease progression crossover to combination treatment with RO5323441 will be allowed.~   "
133413|NCT01308710|"~     Children with high cholesterol levels are especially vulnerable and are at high risk for~     early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of~     CHD, is present in children with elevated cholesterol levels as early as 8 years of age. The~     long term objective of this study is to develop dietary interventions for the prevention and~     treatment of endothelial dysfunction in children with common lipid disorders including~     familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing~     evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have~     cardioprotective effects. The specific aims of the study are to: determine whether a~     Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves~     endothelial function; evaluate the effects of the dietary interventions on lipids and~     lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for~     oxidative stress and inflammation. This study is a randomized, double-blind,~     placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the~     Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral~     intervention will be conducted over 6 months with individual counseling and group sessions.~     Endothelial function will be measured noninvasively by high resolution ultrasound of the~     brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a~     new intervention designed for children at high risk for early CHD with a dietary component~     and supplementation with ω-3 fatty acids. If effective, this intervention would be broadly~     applicable in the community and lend valuable insight about dietary therapy to prevent the~     progression of CHD in hyperlipidemic children.~   "
133414|NCT01308697|"~     Flail chest refers to a section of the rib cage that has broken away from the surrounding~     ribs. Usually, more than one rib is involved, and they are broken in at least two places.~     Flail chest typically is the result of blunt chest trauma. As a result of flail chest, the~     chest wall becomes unstable and dangers of life threatening respiratory failure and~     hypoxemia (lack of oxygen to circulating blood which will lead to organ damage or~     failure)occur.~      Currently, these injuries are treated non operatively. However, small case series have~     demonstrated that operative management can improve Intensive Care Unit (ICU) length of stay,~     improved pulmonary function and decreased pain leading to decreased duration of mechanical~     ventilation, and the incidence of complications related to this injury.~      This study hopes to provide information on whether a prospective randomized trial is~     feasible by first undertaking a small pilot study to determine rate of recruitment, data~     collection methods, and integrity of study protocol.~      Null Hypothesis 1: Enrollment of subjects with flail chest rib fractures into a prospective~     multi-centre RCT is not feasible and a larger clinical trial is unlikely to be completed.~   "
133415|NCT01308684|"~     This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in~     combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the~     dose-finding part, patients will receive intravenous escalating doses of RO5323441 in~     combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part,~     patients will be randomized to receive the established dose (from the dose-finding part) of~     RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue~     treatment with RO5323441 and Avastin on the study until evidence of progressive disease or~     unacceptable adverse events happen. In the efficacy-finding part, patients will receive~     study treatment until disease progression or death.~   "
133416|NCT01308671|"~     The purpose of this study is to investigate the effects of steady-state varenicline on the~     antiplatelet action of clopidogrel in patients with coronary artery disease.~   "
133417|NCT01308658|"~     In this study participants will be given 800 mg darunavir, either as one 800-mg tablet~     formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to~     evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed~     conditions.~   "
133418|NCT01308645|"~     The purpose of this study is to determine efficacy of SB injection in Hepatocellular~     Carcinoma (HCC).~   "
133419|NCT01308632|"~     Indication:~      Subjects with glioblastoma at first relapse after surgery, radiotherapy and first-line~     temozolomide (TMZ).~      Objectives:~        1. Phase I endpoint:~           - To determine the maximum tolerated dose (MTD) of CPT-11 administered on days 8 and 22~          in combination with a fixed, continuous, and metronomic regimen of TMZ, given in 28-day~          cycles.~        2. Phase II endpoints:~      Primary endpoint: Progression-free survival at 6 months. Secondary endpoints: Response rate,~     toxicity profile, overall survival.~      Complementary studies:~      To assess the effect of treatment on plasma concentration of thrombospondin-1 (TSP1),~     soluble VEGF receptor 1 (sVEGF-1) and VEGF-A, and their correlation with clinical outcome.~        -  To assess the correlation between immunohistochemical expression of PTEN and MGMT~          proteins, and clinical outcomes.~   "
133420|NCT01308619|"~     The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg~     immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo~     in the skin of adults with papulopustular rosacea and to identify a correlation, if any,~     with rosacea-related inflammatory markers.~   "
133421|NCT01308606|"~     The purpose of this study is to compare absorption of TMC435 formulated as 2 different types~     of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when~     taken under fasting conditions or together with a standard or a high-fat meal. This will be~     done in healthy volunteers.~   "
133422|NCT01308593|"~     Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated~     by patient satisfaction~   "
133423|NCT01308580|"~     Primary Objective:~      - To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20~     mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in~     participants with metastatic castration resistant prostate cancer (mCRPC) previously treated~     with a docetaxel-containing regimen.~      Secondary Objectives:~        -  To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was~          better tolerated than Cabazitaxel 25 mg/m².~        -  To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:~             -  Progression Free Survival (PFS) defined as the first occurrence of any of the~               following events: tumor progression per Response Evaluation Criteria In Solid~               Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or~               death due to any cause;~             -  PSA Progression;~             -  Pain progression;~             -  Tumor response in participants with measurable disease (RECIST 1.1);~             -  PSA response;~             -  Pain response in participants with stable pain at baseline.~        -  To compare Health-related Quality of Life (HRQoL).~        -  To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.~   "
133424|NCT01308567|"~     Primary Objective:~        -  To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20~          mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS)~          in patients with metastatic castration resistant prostate cancer (mCRPC) and not~          previously treated with chemotherapy.~      Secondary Objectives:~        -  To evaluate safety in the 3 treatment arms.~        -  To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² to docetaxel for:~             -  Progression Free Survival (PFS) (RECIST 1.1)~             -  Tumor progression free survival (RECIST 1.1)~             -  Tumor response in patients with measurable disease (RECIST 1.1),~             -  PSA response~             -  PSA-Progression free survival (PSA-PFS).~             -  Pain response in patients with stable pain at baseline~             -  Pain progression free survival~             -  Time to occurrence of any skeletal related events (SRE)~        -  To compare Health-Related Quality of Life (HRQL).~        -  To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.~   "
133425|NCT01308554|"~     The purpose of this study is to determine whether injection of bupivacaine into the TAP is~     effective in the treatment of post operative pain after laparoscopic gastric bypass~   "
133426|NCT01308541|"~     The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD)~     of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion~     of propofol injectable emulsion.~   "
133427|NCT01308528|"~     The purpose of this study is to compare the safety and security and efficacy of sodium~     enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane~     (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop~     Thromboembolic Disease Undergoing Geral Abdominal Surgery.~   "
133428|NCT01308515|"~     The purpose of this study is to compare the performance of two FDA-cleared tibial bearings~     (replacement for cartilage in the knee) by collecting data on patients through 3 years of~     follow-up.~   "
133429|NCT01308502|"~     The purpose of this study is to evaluate the utility of a minimally invasive nasopharyngeal~     pH probe for the diagnosis of laryngopharyngeal reflux (LPR) in children with airway~     compromise; to determine whether it is comparable to the gold standard esophageal pH probe~     in identifying LPR in this population; and to correlate results of pH testing with validated~     questionnaires. Our hypothesis is that a nasopharyngeal pH probe is equivalent to an~     esophageal probe in identifying laryngopharyngeal reflux.~   "
133430|NCT01308489|"~     This randomized clinical trial studies minimally invasive surgery in treating patients with~     spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor~     resection are less invasive types of surgery for spinal tumors and may have fewer side~     effects and improve recovery~   "
133431|NCT01308476|"~     6 months open label non-interventional observational study acc to § 4, section 23 and § 67,~     section 6 German Medicines Act with two parallel groups~        1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram~        2. the control group not receiving a daily SMS reminder~   "
133432|NCT01308463|"~     The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be~     consented at the two year or next scheduled follow-up period for the early-enrolled~     patients.~   "
133433|NCT01308450|"~     This study is being conducted to enhance and extend the clinical utility of the Quotient®~     ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened~     controls to the existing Quotient® ADHD System database of adolescents and adults (ages~     15-55).~   "
133434|NCT01308437|"~     This is an open label, randomized, parallel group comparison of the immunogenicity safety of~     Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based~     human insulin products (marketed in USA) in type 1 diabetics.~      There are two phases of the study, which are as follows:~        1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in~          the section below).~        2. Phase 2 is a follow up phase only applicable to Wosulin Arm.~      The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately~     28 weeks for the patients enrolled in the comparator arm.~      Two hundred and forty two patients will be enrolled considering an estimated dropout rate of~     15% for a sample size of approximately 105 evaluable patients per arm. The total planned~     enrollment period for this study is approximately 3 months (90 days).~   "
133435|NCT01308424|"~     The purpose of this study is to determine if a new treatment is effective for the treatment~     of recurrent symptomatic oral herpes virus infections.~   "
133457|NCT01308125|"~     Pressure intermittent coronary sinus occlusion (PICSO) in patients with coronary artery~     disease improves collateral flow index to higher than 30%. PICSO used in this patient~     population is safe, feasible and effective. Safety, feasibility and effectiveness will be~     tested by periprocedural and logistic data.~   "
133436|NCT01308411|"~     Asthma affects 6% of the UK population and costs the NHS 1 billion pounds per year. £473~     million alone is spent on inhaled steroid treatment which is designed to reduce inflammation~     in the breathing tubes.~      Unfortunately knowing whether a patient is on just the right amount of steroid treatment is~     difficult, as asthma is a variable disease and the measures currently used to decide on~     increasing or decreasing steroid treatment bare little resemblance to the actual amount of~     inflammation present. Doctors may not reduce treatment as swiftly as necessary if a~     patient's asthma is well controlled because of concern over asthma attacks; this can result~     in potential over treatment with inhaled steroids. Although steroid treatment is safe, side~     effects can occur, and costs are large, so a strategy helping avoid over treatment would be~     beneficial both to patients and to the NHS.~      As the investigators can more accurately measure airway inflammation present in the~     breathing tubes, using a chemical called nitric oxide present in a patient's breath, the~     investigators might be able to more accurately predict which patients could safely reduce~     their steroid treatment. Measuring nitric oxide is simple, and involves breathing into a~     special machine (similar to a roadside breathalyser). In this study the investigators will~     measure nitric oxide in patients with well controlled asthma, and reduce their asthma~     treatment by 50%. The investigators will then follow up the patients and remeasure their~     nitric oxide. At the end of the study the investigators will see if measurements of nitric~     oxide predicted which patients could safely step down their treatment. If successful this~     could help reduce the overall cost to the NHS of inhaled steroids and reduce steroid~     associated side effects.~   "
133437|NCT01308385|"~     Despite enormous progress insufficient postoperative pain management remains a frequent~     problem in the early postoperative phase after surgery. Furthermore, the pain that persists~     after healing of the surgical wound is a large, but often unrecognized, clinical problem and~     it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain~     leading to chronic disability and psychosocial distress.~      Conditioned Pain Modulation (CPM), also known as the phenomenon pain-inhibits-pain, is a~     reduction in pain somewhere on the body in response to the application of a second painful~     stimulus outside the painful area. In recent years, the CPM has been identified as a~     psycho-physical measure with clinical relevance in characterizing the individual's ability~     to modulate pain and consequently the individual's disposition to acquire painful~     conditions.~      The purpose of this study is primarily to assess the relationship between CPM efficacy and~     clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity~     of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain)~     associated with minimally invasive repair of pectus excavatum. In addition, the study aims~     at identifying other patient- and/or surgery-related factors affecting the course of~     postoperative pain.~      Hypothesis:~      - The greater the positive difference between the experimental pressure pain threshold (kPa)~     measured before and after application of a second painful stimulus (Cold Pressor Test), the~     lower the risk of developing persistent postoperative pain.~      Secondary hypotheses~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful~          stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative~          period.~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful~          stimulus (Cold Pressor Test), the shorter duration of early postoperative pain.~        -  The greater the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful~          stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).~        -  The larger the positive difference between the experimental pressure pain threshold~          (kPa) measured before and after application of a different experimental painful~          stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).~        -  Severe acute pain in the early postoperative period (postoperative days 0-3) is~          positively associated with the development of persistent postoperative pain (6 months~          postoperatively).~        -  Presence of preoperative pain and / or high postoperative use of analgesics and / or~          high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months~          postoperatively.~        -  The higher pain intensity and discomfort associated with brush-evoked allodynia and /~          or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing~          persistent postoperative pain (6 months postoperatively).~        -  High levels of preoperative catastrophizing (assessed on the day of admission) is~          related to the severity of acute pain (rated third postoperative day) and chronic pain~          (assessed 6 months postoperatively), even if controlled for depression and anxiety.~        -  The degree of preoperative positive and negative emotions (as assessed on the day of~          admission) is related to the degree of acute pain (rated third postoperative day) and~          chronic pain (assessed 6 months postoperatively) so that negative emotions are~          associated with high levels of pain, while positive feelings are related to low levels~          of pain.~        -  The study population does not differ significantly from the normal population in terms~          of personality traits (emotional reactions, extraversion, openness to experience,~          friendliness, conscientiousness).~        -  The study population does not experience a significant change in personality traits~          during the first 6 months after surgery.~        -  The quality of life and self-esteem is lower among patients who develop persistent~          postoperative pain compared with pain patients.~        -  Quality of life and self-esteem improve as a result of minimally invasive repair of~          pectus excavatum.~   "
133438|NCT01308372|"~     The purpose of this study is to evaluate the proportion of patients which present a high~     cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7~     French regions (Paris area, North-East, Paris basin, West, South-West, South- East,~     Mediterranean area)~   "
133439|NCT01308359|"~     The purpose of this study is to investigate the hypothesis that glucose administration~     increases fetal movement perception by the pregnant woman.~   "
133440|NCT01308346|"~     The target enrollment goal for the trial was to enroll 36 subjects. However due to a~     challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the~     trial was initiated in June 2011.~      To evaluate the following in participants undergoing coronary artery scaffolding/stenting~     for significant coronary artery disease:~        -  The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold~          (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological~          responsiveness of the target coronary artery~        -  The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and~          physiological responsiveness of the target coronary artery~   "
133441|NCT01308333|"~     X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder~     characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse~     hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead~     to chronic inflammatory processes in airways and eyes of the affected individuals. The~     investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis~     and blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal~     fluid in these subjects, evaluate lung function and assess chronic inflammatory processes in~     the airways by NO measurements. The data should provide a basis for genotype-phenotype~     correlations.~   "
133442|NCT01308320|"~     Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general~     anaesthesia through binding to its receptors in the brainstem. However, it has not been~     proven if fentanyl has a complication-free, dose-dependent effect on cough suppression~     during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the~     relationship between fentanyl doses and cough suppression during emergence from sevoflurane~     anaesthesia.~   "
133443|NCT01308307|"~     Purpose: : This study was performed to compare the accuracy of non-cycloplegic~     photorefraction with cycloplegic refraction in detection of refractive amblyopia risk~     factors and determine some corresponding beneficial cut points.~      Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years)~     underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then~     cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction~     results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D)~     were set as criteria based on AAPOS guidelines. The difference in detection of refractive~     amblyopia risk factors between the two methods was the main outcome measure.~   "
133444|NCT01308294|"~     The purpose of this study is to determine whether vaccination with tumor antigenic peptides~     and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma~     patients and to assess the safety and tolerability of this vaccination. Tumor responses~     following this vaccination will also be documented.~   "
133445|NCT01308281|"~     This study is designed as a prospective, randomized, multi-center trial to demonstrate an~     inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting~     stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary~     objective and safety of 6- month dual antiplatelet therapy following EES implantation in~     comparison with a 12-month dual antiplatelet therapy.~   "
133446|NCT01308268|"~     The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a~     highly endemic area in northern Argentina with a multidisciplinary approach. The specific~     objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology~     method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration~     regimen with albendazole and ivermectin.~   "
133447|NCT01308255|"~     This is a placebo controlled randomised clinical trial.Patients attending Yorkshire Early~     Arthritis Clinics and diagnosed with rheumatoid arthritis with symptom duration of 3−12~     months will be recruited. They will be randomised to blinded therapy with either~     methotrexate and intravenous corticosteroid at baseline, or methotrexate and intravenous~     infliximab according to the standard treatment regime. Patients will be followed regularly,~     and at each visit, if the patients are not in remission, they will be given an intramuscular~     injection of corticosteroid. After 26 weeks, all patients will be unblinded and those with~     an inadequate treatment response will be treated according to a dose escalation algorithm~     until they achieve remission. Those in remission will continue on blinded therapy and if 6~     months of remission is achieved the intravenous agent (infliximab or placebo) will be~     withdrawn.~   "
133448|NCT01308242|"~     Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the~     homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with CKD~     and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also~     predictive of progression of CKD and predict mortality in CKD. Although studies in normal~     individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary~     and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been~     reported. Our objectives are to determine if phosphate reduction through the use of~     non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will~     also be investigating associations of elevation in FGF 23 levels with commonly encountered~     co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and~     Hypertension.~   "
133449|NCT01308229|"~     The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting~     Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in~     native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side~     branch reference vessel diameter of 2.0-3.0 mm.~   "
133450|NCT01308216|"~     The aim of this study is to determine the efficacy of transcranial laser therapy applied in~     automatic noncontact scanning mode for improving functional disability in patients with~     hemiplegia from ischemic stroke undergoing a rehabilitation program.~   "
133451|NCT01308203|"~     -  Clinical studies with statins have shown that patients that suffered a cardiovascular~          event have a high residual risk. Residual risk decreases with the attaining of~          progressive lower LDL-C levels.~        -  In patients treated with statins, HDL-C level is an independent inverse predictor of~          subsequent CV and coronary plaque progression, even when LDL-C levels are less than 70~          mg/dL.~        -  Therefore the purpose on this study is to assess the lipid efficacy on lipid profile~          and effects on HDL-C metabolism and function of the extended release niacin/laropiprant~          combination added to usual therapy in very high risk patients with cardiovascular~          disease and low HDL-C that did not achieve the optional very low LDL-C or non-HDL-C~          goals~   "
133452|NCT01308190|"~     The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The~     technique involves a low anterior rectal or colo-anal resection, very often associated with~     a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal~     endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with~     minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas~     consider TEM to be the technique of choice. However the treatment of T2 rectal cancers~     remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant~     reduction in local recurrence and an increase in survival.~      Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up~     to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3~     N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve~     effective results in terms of local recurrence similar to radical surgery (TME).~      OBJECTIVES:~      Primary: To compare the results of local recurrence at 2 years in patients treated with~     preoperative chemoradiotherapy and TEM and in patients treated with conventional radical~     surgery (TME).~      Secondary: To analyse the 3-year survival results in patients treated with CT/RT.~      Methodology: Multicenter clinical trial in a calculated sample of 173 patients.~   "
133453|NCT01308177|"~     -  Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas~          and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger~          specimens. However, ESD has more frequent complications (delayed bleeding, ulcer~          healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed~          bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing~          agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as~          first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other~          combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding.~        -  Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric~          ulcers. Recently, one study showed the additional benefits of using ES in combination~          with the PPI after ESD. however, this study did not show the difference of delayed~          bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated~          the difference of delayed bleeding and the benefit of ulcer pain control after ESD.~   "
133454|NCT01308164|"~     The objective of this feasibility study is to evaluate the efficacy and safety of automated~     determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration~     and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1~     diabetes.~      Study design:~      Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic~     pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing~     MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will~     be initiated after the pilot segment (including data analysis). The pilot segment will~     include 15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and~     55 adults under a separate protocol)eligible subjects will be enrolled to allow for 92~     valuable subjects at the end of the study. The subject population will be randomly assigned~     1:1 to either the intervention group or control group. At this pediatric sub study~     approximately 50 patients will participate and at the separate Adults study additional 55~     adult patients will participate.~   "
133455|NCT01308151|"~     Aim:~      To adapt and develop a culturally appropriate psychological intervention and test its~     feasibility, and acceptability for the patients presenting to general hospital following~     self-harm in Karachi Pakistan.~      Primary hypothesis:~      Patients who receive cognitive behavioral therapy will show significant decrease in suicidal~     ideation as compared to patients with treatment as usual.~      Design:~      Randomized Control Trial~      Setting:~      Medical Departments of General Hospitals in Karachi.~      Participants:~      A total of 200 self harm patients will be randomized to psychological intervention and~     treatment as usual arm.~      Intervention:~      Culturally Adapted Cognitive Behavioral Therapy (CBT)~      Outcome measure:~      Beck Suicidal Ideation Scale~   "
133456|NCT01308138|"~     The main focus of the project is to determine to what degree myocardial energy metabolism is~     linked to impaired function in human cardiomyocytes, whether exercise training and remote~     ischemic preconditioning can restore cardiomyocyte function and whether this is linked to~     improved mitochondrial and cell function.~   "
133459|NCT01308099|"~     The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have~     different levels of certain chemicals in their blood than people who don't have POTS. This~     study will test whether the blood vessels of people with POTS will react differently to~     certain tests than people without POTS.~      The hypothesis of the study is:~      Patients with POTS will have vascular endothelial dysfunction compared with control~     subjects.~   "
133460|NCT01308086|"~     The purpose of this study is to compare whether a 3-month treatment is at least not inferior~     to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of~     RFS in patients with high risk stage II or stage III radically resected colon cancer.~   "
133461|NCT01308073|"~     The investigators aim to show, whether all middle molecules are included in the clearance~     and whether this clearance is stable until 72 hours.~   "
133462|NCT01308060|"~     This double-blind study has two parts for each subject (same population):~      Part A: initial treatment in CL (placebo-controlled):~        -  To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo~          in the improvement of moderate to severe Lateral Canthal Lines.~        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal~          Lines compared to placebo.~      Part B: repeated treatment in CL with or without GL (active treatment, up to 1 year):~        -  To assess safety of Azzalure® following repeated administration in the improvement of~          moderate to severe Lateral Canthal Lines.~        -  To assess the safety of Azzalure® when used concomitantly for improvement of moderate~          to severe Lateral Canthal Lines and Glabellar Lines.~        -  To assess the subjects' level of satisfaction with the appearance their Lateral Canthal~          Lines.~   "
133463|NCT01308047|"~     The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine~     with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for~     Orthopedic Procedures in the Lower Limbs.~   "
133464|NCT01308034|"~     The purpose of this study is to determine the safety of continuous dosing of sunitinib in~     association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor)~     sarcomas who cannot be treated by surgery.~      The primary objective of the study is to determine the maximum tolerated dose (MTD) of~     continuous dosing of sunitinib in association with radiotherapy in patients with non GIST~     sarcomas who cannot be treated by surgery.~      This study is a multicentre, open-label phase I with dose escalation : 3 dose levels.~      3-6 patients will be included at each dose level.3-18 patients will be included in the~     study.~   "
133465|NCT01308021|"~     The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived~     peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.~   "
133466|NCT01308008|"~     The goal of the proposed research is to test whether a long-term exercise program in~     sedentary Veterans with diabetes will produce sustained improvement in mobility performance~     and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged~     60 and over) will be randomly allocated into a customized, primarily home-based,~     functionally-oriented exercise program with nurse support intervention (I) group versus a~     flexibility and toning, health education control (C) group, and test outcomes in functional~     mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to~     an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting~     older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this~     should create a model to which physicians and other providers could refer comorbid diabetes~     patients.~   "
133467|NCT01307995|"~     The aim of this study is to evaluate the reduced incretin effect observed in patients with~     T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and~     iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post~     partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in~     patients with other forms of DM. The investigators estimate that approximately 90 % of the~     patients with GDM re-establish a NGT 2-3 months post partum. This particular group of~     patients provides a unique possibility for demonstrating the reversibility of the reduced~     incretin effect in relation to optimal glycaemic control.~   "
133468|NCT01307982|"~     This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen~     fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents~     with functional and intellectual impairment who have gastrostomy feeding tubes and medically~     refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to~     establish feasibility before initiating a multi-centered study.~   "
133469|NCT01307969|"~     This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated~     ropivacaine formulation for dental anesthesia.~   "
133470|NCT01307956|"~     RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high energy x-rays to kill tumor cells. Giving monoclonal antibody~     therapy together with chemotherapy and radiation therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving panitumumab, combination~     chemotherapy, and radiation therapy together before surgery works in treating patients with~     advanced esophageal or gastroesophageal (GE) junction cancer~   "
133471|NCT01307943|"~     Mindfulness-based stress reduction (MBSR) is a group program in which participants are~     taught to be mindful or present-focused. MBSR programs consist of instruction in a variety~     of mindfulness meditations including body scan, sitting meditation, mindful yoga, and~     discussion of these practices. Our study purpose is to develop and conduct a pilot~     mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative~     interviews, and brain imaging to assess the impact of the intervention on children with~     mental health challenges.~   "
133472|NCT01307930|"~     This study will find how weight affects the dosing of a drug called anidulafungin.~     Currently, the amount of anidulafungin a patient receives is the same regardless of the~     patient's weight.~   "
133473|NCT01307917|"~     Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading~     complication of diabetes, and attempts to maintain close glycemic control do not prevent the~     sequelae that claim the lives and quality of life of millions of diabetics each year. Up to~     forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy,~     the most common cause of end-stage renal disease requiring dialysis in the US.~     Flavonoid-rich diets are a promising intervention to prevent the endothelial dysfunction~     that apparently leads to this deadly complication. The mechanisms are still unclear but~     probably involve nitric oxide synthesis. The investigators hypothesize that early~     maintenance of the integrity of renal vasculature will significantly improve the lifelong~     prognosis for patients with diabetes. Flavonoids with anti-inflammatory and antioxidant~     activities could be used to protect endothelial function, and together with good glycemic~     control, prevent the development and progression of nephropathy. The investigators aims are~     to:~        1. compare endothelial function by studying reactive hyperemia, nitric oxide, and~          proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy~          sex- and age-matched control subjects.~        2. identify early markers in urine for vascular endothelial injury.~        3. examine the effects of flavonoids on vascular function, urine nitric oxide, and~          proinflammatory factors in patients with diabetes mellitus.~   "
133474|NCT01307904|"~     The main objectives of this study is to measure the composition of five common types of~     dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices~     (GI) of these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and~     ten subjects with type 2 diabetes mellitus were enrolled in the study.~      The dates' flesh composition analysis showed that the dates contain a high percentage of~     carbohydrate (total sugars, 65-68%).~      The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5,~     46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively.~     Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar~     46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified~     as low glycemic index food items.~   "
133475|NCT01307891|"~     Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer~     deaths in American women. Metastatic disease including metastatic breast cancer~     unfortunately remains incurable. One reason is due to the inability to develop specific~     therapies for specific cancer subsets.~      The use of modern genomic techniques has significantly enhanced our recent understanding of~     breast cancer biology. Five distinct breast cancer subsets have been recognized, one of~     which is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor~     (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor~     receptor 2 (HER-2-Neu) negative. This is referred to as triple negative breast cancer or~     TBNC. TBNC represents a significant proportion of breast cancer patients (10-20%) and has a~     poor prognosis with no targeted approach to therapy as of yet.~      Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast~     cancer cells. Previous studies have shown that combining antibodies with selected~     chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use~     tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC~     patients.~   "
133476|NCT01307878|"~     Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal~     cancer without bleeding, obstruction, etc.~   "
133477|NCT01307865|"~     The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic~     rejuvenation of the midface complex. The investigators plan to both qualitatively determine~     the restoration of midface architecture as well as quantitatively document the change in~     midface volume by employing three-dimensional (3D) surface imaging which critically analyzes~     volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic~     injections will experience significant improvement in facial midface volume restoration.~        -  Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using~          three-dimensional digital surface imaging~        -  Determine the mean change from baseline in facial contour via quantitative volumetric~          measurements~        -  Correlate volumetric correction with clinical improvement as measured by the Facial~          Lipoatrophy Panel grading system~        -  Correlate the mean volumetric change in midfacial treatment area with the amount of~          product used~        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject~          visual aid during the course of treatment~        -  Collect safety data~   "
133478|NCT01307852|"~     The goal of this clinical research study is to learn if a rectal balloon with attached~     radiation detectors can be used to help researchers monitor the dose of external beam~     radiation that is delivered to the prostate during treatment. This may help researchers~     better understand the side effects of radiation therapy, such as rectal bleeding, and may~     lead to changes in treatment planning or treatment delivery.~   "
133479|NCT01307839|"~     Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural~     placement in laboring parturients1. Skin infiltration, although brief, can be very stressful~     and painful for patients.2 This initial discomfort may cause patient anxiety, thus~     increasing the pain and decreasing the satisfaction with the procedure. To reduce this~     discomfort, various topical alternatives have been investigated with varying degrees of~     success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available,~     the investigators would like to determine if it can reduce the pain of skin infiltration in~     particular and epidural placement as a whole.~   "
133480|NCT01307826|"~     The purpose of this study is to compare classical massage and massage based on the~     tensegrity rule in treating people with painful shoulder.~   "
133493|NCT01307631|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
133529|NCT01307163|"~     Saliva is used nowadays as a significant diagnostic tool due to the latest technological~     developments. The research compares two experimental groups; children after liver~     transplantation and a control group.~      Our objective is to identify from all the parameters that are evaluated, the ones that~     differ between the two groups. If such parameters will be found and differ statistically, it~     will be possible to create a non invasive medical examination protocol, which will probably~     be much more complaint, and being so would help locate individuals in risk groups with the~     tendency to develop an end-organ liver disease.~   "
133481|NCT01307813|"~     The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches~     to a standard double channel endoscope. The Overstitch can place sutures under endoscopic~     guidance, with the goal of reproducing standard surgical techniques. These would include~     hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices,~     or repair/closure of mucosal or full thickness defects such as perforations or endoscopic~     mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided~     by an endoscopic cinching device that passes through the channel of the endoscope.~      This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch)~     to endoscopically place sutures into normal mucosa, and then tie the sutures with the~     cinching device. These devices have been utilized effectively in explant, live porcine, and~     human cadaver colon and stomach models. In this treat and resect model, sutures would be~     placed in a segment of colon or stomach that is being surgically removed via open or~     laparoscopic technique for the treatment of benign or malignant disease. The sutures would~     be placed in a segment of normal mucosa remote to the pathology being surgically treated. In~     addition, the sutures will be placed under direct observation via laparoscopic or open~     visualization. After resection of the segment of colon, it will be evaluated grossly for~     level of suture placement, evidence of perforation, and quality of suture approximation with~     the cinching device.~   "
133482|NCT01307800|"~     The purpose of this study is to determine whether at least 1 dose level of LY2140023 given~     to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy~     as compared to placebo.~   "
133483|NCT01307787|"~     The purpose of this study is to evaluate the effects of a group-based exercise and~     educational program for people with Rheumatoid Arthritis (RA) on physical performance and~     disease-self-management.~   "
133484|NCT01307774|"~     To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and~     cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in~     Mysore District, India.~      Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer~     will predict acceptability of HPV vaccination among parents of rural adolescent girls in~     Mysore, India.~   "
133485|NCT01307761|"~     The purpose of the investigators study is to retrospectively evaluate the predictors of~     malignant thyroid nodules and established an useful scoring system based on sonographic~     findings and demographic data.~   "
133486|NCT01307748|"~     The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about~     how aromatherapy works.~   "
133487|NCT01307735|"~     Myocarditis is an inflammatory heart disease primarily of viral origin that can lead to~     heart failure and death. Despite an unfavorable long-term outcome and mortality rate as high~     as 50%, classification, diagnosis, and treatment of myocarditis remains controversial. The~     gold standard for clinical diagnosis is direct sampling of the heart muscle, which often~     misses the infected area and thus reliability of the test is questionable. While the cause~     and clinical presentation of myocarditis are often unclear, inflammation of the heart muscle~     can be clearly imaged by Cardiovascular Magnetic Resonance Imaging (CMR).~      Due to recent international consensus on CMR protocol for myocarditis and the unique ability~     of CMR to visualize cardiac structure, function, and characterize tissue, CMR has become the~     primary tool for clinical assessment. This study aims to test the accuracy of CMR in the~     diagnosis of myocarditis and to validate whether CMR acquired in an early stage of~     myocarditis can provide incremental prognostic information. In order to effectively gather~     relevant clinical data, an online, multi-centre international registry will be established~     across twenty different medical institutions.~      Hypotheses:~        1. CMR accurately detects active myocardial inflammation in patients with myocarditis~        2. CMR acquired in an early clinical stage of myocarditis provides incremental prognostic~          information superior to standard clinical diagnostic tools.~   "
133488|NCT01307722|"~     Background and Purpose- According to our prior studies, left atrial (LA) distensibility was~     associated significantly with left ventricular filling pressure in patients with acute~     myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA~     distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict~     in-hospital mortality in AMI patients. In the current study, left atrial distensibility~     guiding management in advanced chronic heart failure will be performed to assess whether~     those management could influence long-term prognosis including mortality rate,~     rehospitalization rate and the duration of rehospitalization.~      Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular~     ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class~     III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart~     failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three~     hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation~     served as LA distensibility guided treatment group (guide group) and another 100 patients,~     either sinus rhythm or atrial fibrillation, served as control group. The management of guide~     group will be adjusted by LA distensibility, including the dose of inotropic agents,~     diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time~     per 2 week at first 3 months, then 1 time per month later. The control group will be treated~     by conventional management and traditional echocardiography can be performed as in-charge~     doctor request. The necessity of hospitalization for heart failure will be adjusted by 2~     cardiovascular specialists and all patients admitted for heart failure will be managed by~     the same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up~     will be 2 years. For life-threatening heart failure, intravenous nitroprusside drip under~     continuous A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion,~     intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor.~     The primary end-point will be all-cause mortality. The second end-points will be heart~     failure with hospitalization and the duration of each hospitalization. Additionally, the~     ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents,~     beta blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate~     the trends of heart function (either systolic or diastolic) and renal function during 2-year~     follow-up according to whether guiding by LA distensibility is done or not.~   "
133489|NCT01307696|"~     Meshes-devices using dual-sided mesh technology have been developed for the specific~     indication of small ventral hernias. The design of these meshes allows introduction of a~     mesh of appropriate size to cover the hernia defect, through a small incision. This~     technique is very attractive for the surgeon and the patients because the mesh usually can~     be introduced through a nearly invisible scar in the umbilicus. The avoidance of fixation~     sutures omits the pain related to these sutures. Short-term results and patient satisfaction~     are very favorable, encouraging the surgeons to continue with the technique, although~     long-term results of these meshes in good quality studies are lacking.~   "
133490|NCT01307683|"~     The MAMAS study is built on the premise that simple recommendations for diet and exercise~     may not be enough to encourage healthy weight gain during pregnancy. Psychological skills~     training may be necessary to help women deal with stress and cravings; learn to regulate~     difficult emotions; increase awareness; and encourage healthy eating and physical activity.~     The goal of this study is to find out whether a behavioral stress reduction intervention can~     help women achieve healthy weight gain during pregnancy and reduce stress.~   "
133494|NCT01307618|"~     This randomized phase II trial is studying how well giving vaccine therapy together with or~     without recombinant interleukin-12 followed by daclizumab works in treating patients with~     melanoma that has spread to other places in the body. Vaccines made from peptides or~     antigens may help the body build an effective immune response to kill tumor cells.~     Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by~     stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as~     daclizumab, may decrease the number of regulatory T cells (T cells that suppress the~     activation of the immmune system) and may lead to a better immune response against melanoma.~     It is not yet known whether vaccine therapy is more effective with interleukin-12 and~     daclizumab in treating melanoma.~   "
133495|NCT01307605|"~     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may~     stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet~     known whether rituximab is more effective when given alone or together with lenalidomide in~     treating patients with follicular lymphoma.~      PURPOSE: This randomized phase II trial is studying rituximab to see how well it works~     compared with giving rituximab together with lenalidomide in treating patients with~     previously untreated follicular lymphoma.~   "
133496|NCT01307592|"~     RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and ,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell~     growth in different ways. Some block the ability of cancer cells to grow and spread. Others~     find cancer cells and help kill them or carry cancer-killing substances to them.~     Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the~     cancer. Giving rituximab and chemotherapy together with lenalidomide may kill more cancer~     cells.~      PURPOSE: This phase II trial is studying how well giving rituximab, gemcitabine~     hydrochloride, and oxaliplatin together with lenalidomide works in treating patients with~     relapsed or refractory, aggressive non-Hodgkin lymphoma.~   "
133497|NCT01307579|"~     This randomized phase III trial studies caspofungin acetate to see how it works compared to~     fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia~     who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal~     infections caused by chemotherapy. It is not yet known whether fluconazole is more effective~     than caspofungin acetate in preventing fungal infections in patients with acute myeloid~     leukemia who are undergoing chemotherapy.~   "
133498|NCT01307566|"~     The main purpose of this study is to measure the evolution of hemoglobin A1c level after~     treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic~     control and associated moderate or severe obstructive sleep apnea.~   "
133499|NCT01307553|"~     The purpose of this study is to track the clinical safety and effectiveness of the~     Pericardium Covered Stent in real world use.~   "
133500|NCT01307540|"~     Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.~      Methods: patients will be treated with either active light-emitting device or inactive~     light-emitting device. Daily treatment with light therapy will start at the beginning of the~     conditioning regimen and will last until day 21 post-transplant. Each daily treatment last~     about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a~     weekly basis.~   "
133501|NCT01307527|"~     Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare~     collagen-connective tissue disorders that predispose affected individuals to the development~     of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies~     evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal~     rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe~     that it can increase the corneal stability in patients affected these disseases, preventing~     perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal~     transplants to successfully be performed on blind eyes that have already perforated and~     opacified. The purpose of the study is to determine whether corneal crosslinking can be~     safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type~     VI.~   "
133502|NCT01307514|"~     The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin~     analogs and their dependence on external and physiological alterations. The investigators~     plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in~     the presence of increased perfusion of the delivery site, achieved by way of local warming,~     movement and topical application of Capsaicin cream. The investigators will also test the~     effect of local heating and topical application of Capsaicin cream on the post prandial~     glucose levels following a bolus.~   "
133503|NCT01307501|"~     ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors~     less than or equal to 3.5 cm in patients with pulmonary metastatic disease.~   "
133504|NCT01307488|"~     A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected~     subjects in their first antiretroviral regimen and who are virologically suppressed on a~     regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to~     ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.~   "
133525|NCT01307215|"~     Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP~     block is a procedure used to reach the nerve endings in the abdominal wall so that there is~     a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will~     be injected after surgery. The aim of this study is to determine the effect of changes in~     the volume of the injection.~   "
133526|NCT01307202|"~     Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain~     management can be a challenge. Different measures have been introduced to manage severe~     postoperative pain int hese patients. Previous studies have investigated gabapentin in acute~     postoperative pain and demonstrated reducted pain, postoperative morphine consumption,~     morphine related side effects, and postoperative pain scores. To date, this analgesia~     adjunct has yet to be investigated in total joint arthroplasty patients.~   "
133530|NCT01307150|"~     The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis~     and quality of life after 4 weeks of treatment in the Dead Sea.~   "
133505|NCT01307475|"~     Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before~     birth, involving primarily limb and craniofacial deformities.~      The hypotheses in the present study of FSS and related conditions are: (1) FSS and related~     conditions are associated with higher rates of posttraumatic stress symptoms (PTSS),~     depression, and reduced quality of life than is observed in the general population; (2)~     persons close to an individual with FSS or related condition suffer similarly; and (3)~     current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial~     deformities, or limb deformities), do not capture the unique picture of FSS and related~     conditions, which involve both limb and craniofacial deformities in an intellectually~     capable individual.~      There have been no studies looking at quality of life associated with FSS. Some authors have~     looked at quality of life in persons with facial differences; other authors have looked at~     bone and joint problems. Many other authors have looked at PTSS and depression caused by~     health problems and bad medical experiences. No authors have looked at these problems when~     they happen together, as they do in FSS. Because of the above, there may be differences in~     patients that have FSS versus patients in previous quality of life studies. The study will~     also develop and validate an outcomes-based quality of life survey for FSS and related~     conditions.~   "
133506|NCT01307462|"~     This phase II trial studies how well giving fluticasone propionate, azithromycin, and~     montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans~     who previously underwent stem cell transplant. FAM may be an effective treatment for~     bronchiolitis obliterans~   "
133507|NCT01307449|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection~     in the elderly in particular. This could be explained by a defect in the early responses of~     an ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the~     geriatric population.~      In this trial, the investigators will study the immunologic differences of two FDA approved~     licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy~     volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of~     60-89 will be enrolled in the study. Each participant in the study will be given one~     pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days,~     seven days, fourteen days, as well as one month and six months after vaccination. Throughout~     the duration of the study, the participants will be monitored for safety.~   "
133508|NCT01307436|"~     The primary purpose of this study was to assess whether the protection afforded by Epaxal~     vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus~     influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and~     (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the~     protection afforded by Epaxal administered alone. The aim of the follow-up phase is to~     obtain information on the long term protection afforded by Epaxal, and to compare this with~     an alternative hepatitis A vaccine (Havrix).~   "
133509|NCT01307423|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis who have not been previously treated with~     DMARDs.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
133510|NCT01307410|"~     In 2010, the sponsor conducted an observational study, entitled as Nationwide Assessment of~     Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese~     Patients with Type 2 Diabetes - 3B Study  which was to evaluate the level of cardiovascular~     diseases (CVD) risk factor control and its regional difference in China. As a continuation,~     this extension of the 3B Study is designed to assess the incidence of cardiovascular events,~     cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients~     with type 2 diabetes and with high risk of (CVD) with or without existing or history of~     coronary artery diseases.~   "
133511|NCT01307397|"~     This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in~     patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC~     or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily~     orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up~     of 24 months after discontinuation of the study drug.~   "
133512|NCT01307384|"~     This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain~     survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used~     in primary total hip arthroplasty.~   "
133513|NCT01307371|"~     The purpose of this study is to investigate the efficacy and mechanism of bone marrow~     mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with~     ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary~     intervention (PCI).~   "
133514|NCT01307358|"~     The purpose of this research study is to compare the interproximal plaque removal ability of~     Philips Sonicare Interproximal Cleaning Device to floss (Crest Glide) and Waterpik~     Waterflosser. In addition, we seek to learn more about the results of using this device on~     plaque accumulation and what biological processes influence the makeup of plaque and~     reduction of gingivitis.~   "
133527|NCT01307189|"~     This study was designed to test the following hypothesis:~      A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance~     and in the physiological response during the endurance shuttle walk will be greater with~     tiotropium compared to placebo in COPD patients.~      B) Three weeks of bronchodilation will be associated with increase activity of daily living~     as evaluated using the London Chest Activity Daily Living scale.~   "
133528|NCT01307176|"~     The purpose of this study is to determine whether a person's ability to adapt (i.e. short~     term motor learning) predicts their ability to benefit from physical therapy exercises.~   "
133575|NCT01306565|"~     The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in~     reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non~     ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.~   "
133576|NCT01306552|"~     The purpose of this study is to evaluate the effectiveness of a combined parent-student~     program for smoking prevention in 7th graders in Berlin schools.~   "
133515|NCT01307345|"~     This pilot project proposes to monitor real-world alcohol use using a novel technology—cell~     phone videorecordings in conjunction with breathalyzer recordings—and to conduct a small~     randomized study of this technology for reinforcing alcohol abstinence. Individuals with~     frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld~     breathalyzer for one month. Participants will be randomized to one of two conditions:~     alcohol monitoring or alcohol monitoring plus contingency management. In both conditions,~     research assistants will telephone participants on their cell phone an average of 10 times~     per week to request submission of a breathalyzer sample using the video monitoring function~     on the cell phone. Samples will be time and date stamped, and the video containing the~     breathalyzer result will be sent to study staff via the cell phone. Participants will be~     compensated for each video recorded within one hour of receiving the prompt. Participants~     randomized to the contingency management condition will receive the same alcohol monitoring~     described above, and they will also receive reinforcement for each alcohol negative breath~     sample submitted within one hour of the prompt. Data from this pilot project will be useful~     for (1) determining the feasibility of assessing alcohol use in the natural environment via~     breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM~     intervention that reinforces alcohol abstinence using breathalyzers and cell phone~     technology. In an exploratory manner, we will also evaluate the reliability and validity of~     the video monitoring procedure and trends toward changes in psychosocial functioning.~   "
133516|NCT01307332|"~     There are two parts to this investigator sponsored trial (IST):~        1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.~        2. To provide serum samples for the University of Southern California (USC) ICAM125~          lymphocyte recovery study.~   "
133517|NCT01307319|"~     The purpose of this study is to assess the safety and efficacy of an investigational nasal~     aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal~     allergic rhinitis in children (6-11 years of age).~   "
133518|NCT01307306|"~     The central aim of this application is to determine whether improved outcomes with tight~     euglycemic control are due to insulin-specific responses. The investigators hypothesize that~     improving insulin resistance will lead to decreased inflammatory and hypermetabolic~     responses, as well as restored glucose metabolism, and so result in improved clinical~     outcome of severely burned patients.~   "
133519|NCT01307293|"~     The purpose of the study includes:~        1. To develop a treatment manual and pilot test this treatment intervention which is~          designed to prevent and reduce psychological distress in parents who have infants~          hospitalized in the neonatal intensive care unit (NICU).~        2. To conduct a treatment intervention study in which parents of NICU infants will receive~          a 6-12 session treatment designed to reduce psychological distress, and to compare~          outcomes with parents who do not receive the intervention.~      We hope to learn whether or not a simple psychotherapeutic and psychoeducational~     intervention offered to parents of NICU infants can prevent or minimize the development of~     symptoms of psychological distress in parents, including symptoms of anxiety and depression~     and posttraumatic stress disorder (PTSD).~   "
133520|NCT01307280|"~     The study investigated the effectiveness and cost-effectiveness of a cognitive and~     behavioral weight management program, complemented by an interactive Web site and brief~     telephone coaching, implemented among TRICARE non-active-duty beneficiaries.~      A total of 1,755 participants from four Midwestern states were randomized to one of three~     randomized controlled trial groups with increasing intervention intensity: mailed material~     and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and~     Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes~     in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12,~     and 15 to 18 months. Analyses estimated overall cost savings and calculated the~     cost-effectiveness ratio of each randomized controlled trial compared with a do-nothing~     alternative as the cost per quality-adjusted life year.~   "
133521|NCT01307267|"~     A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid~     tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive~     Non-Hodgkin's Lymphoma (NHL).~   "
133522|NCT01307254|"~     The investigators hypothesize that low iron storages protects from and down-grades~     non-alcoholic fatty liver disease.~      The aim of the study is to show the association between the severity of Non-alcoholic fatty~     liver disease to low iron status.~   "
133523|NCT01307241|"~     Results of actual treatment in ALL are not optimal. New prognostic factors, which may~     determine clinical & molecular response are required. Hyper-CVAD is an internationally~     accepted schema for such patients. The objective of this pilot study is to evaluate~     polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the~     function of these proteins, and therefore the intracellular bioavailability of methotrexate.~     Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for~     citarabine intracellular transport and activation, respectively. Clinical characteristics~     will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate~     analysis will be done to evaluate factors influencing on response and survival.~   "
133524|NCT01307228|"~     The investigators have developed an online database called 'Health Systems Evidence,' which~     contains synthesized research evidence and additional details about this evidence that can~     make it easier for health system policymakers to use the included research evidence. The~     investigators have also developed an e-mail alerting service that brings to the attention of~     health system policymakers any new additions to Health Systems Evidence. This study will~     evaluate whether a full-serve version of Health Systems Evidence increases the use of~     research evidence by policy analysts and advisors in the Ontario government as compared to a~     self-serve version. The full-serve version comprises: 1) access to Health Systems~     Evidence; 2) monthly e-mail alerts about new additions to Health Systems Evidence; and 3)~     access to full-text articles that are cited in Health Systems Evidence. The self-serve~     version only provides access to Health Systems Evidence. The investigators will also~     interview study participants to obtain feedback about Health Systems Evidence, including how~     helpful it was in their work, why it was helpful (or not helpful), what aspects were most~     and least helpful and why, and recommendations for improving it.~   "
133577|NCT01306539|"~     Stimulation of the subthalamic nucleus will have effects on various aspects of~     neuropsychiatric function.~   "
133531|NCT01307137|"~     The prevalence of obesity and diabetes in older adults is increasing. Because older adults~     are often portrayed as less likely to change long-standing health behaviors, health~     promotion in this age group has lagged behind others. In fact, little attention has been~     given to the importance of diabetes prevention in community-dwelling older adults through~     the implementation of programs that promote healthy nutrition, increase physical activity~     and improve self-management. The Diabetes Prevention Program (DPP), which demonstrated the~     benefit of modest weight loss on the reduction of diabetes risk (58% overall reduction with~     a 71% reduction in the older population), has yet to be translated into widespread public~     health practice.~      The overall objective of this protocol is to implement evidence-informed, innovative~     interventions to increase adoption of findings from comparative effectiveness research (CER)~     for diabetes management and prevention in South Florida older veterans. Specifically, the~     proposed study will test the hypothesis that Peer-led Care alone (PC), or activated by~     technology (TechnAlert-Peer or TAP), is superior to traditional methods of information~     dissemination (Usual Care or UC) for adoption of CER on prevention and management of~     diabetes, leading to better self-efficacy and clinical outcomes.~      The investigators will conduct a 12-month randomized controlled trial in older veterans with~     prediabetes and diabetes participating in one of the Healthy Aging Regional Collaborative~     programs. Primary outcomes include changes in self-efficacy, weight, and hemoglobin A1c.~     Secondary outcomes include changes in blood pressure, lipids, physical function, quality of~     life, and health care utilization and the evaluation of potential racial/ethnic disparities~     in the process of adoption of CER for prevention and management of diabetes.~      This study is expected to accelerate the implementation of CER evidence for diabetes~     prevention, addressing health and economic challenges in the care of overweight and obese~     veterans.~   "
133532|NCT01307124|"~     To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir~     containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48~     week~   "
133533|NCT01307111|"~     The purpose of this study is to see if using misoprostol makes the intrauterine device~     insertion easier and less painful in women who have never had a baby.~   "
133534|NCT01307098|"~     This is the first clinical study of SBC-102 (sebelipase alfa) for the treatment of LAL~     Deficiency. It is an open label dose escalation study in adult patients with liver~     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency and will examine three doses of~     SBC-102 (sebelipase alfa). The targeted number for this study is 9 evaluable subjects.~   "
133535|NCT01307085|"~     The purpose of this study is to determine whether ischemic preconditioning reduces lung~     injury in patients undergoing pulmonary resection.~   "
133536|NCT01307072|"~     The relationship between the surgical outcome of vitreous surgery for proliferative diabetic~     retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.~   "
133537|NCT01307059|"~     This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via~     Easypod™.~   "
133538|NCT01307046|"~     This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension~     participants who are not adequately controlled with losartan.~   "
133539|NCT01307033|"~     This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in~     essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).~   "
133540|NCT01307020|"~     The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol~     and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single~     component in comparison to placebo on moderate to severe pain following impacted third~     mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate~     the pain model.~   "
133541|NCT01307007|"~     The primary objective of this study is to assess the safety of an investigational~     intravenous iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore~     the mechanism of hypophosphatemia following administration of FCM or that of an equal dose~     of iron dextran when treating women with iron deficiency anemia due to heavy uterine~     bleeding (HUB).~   "
133542|NCT01306994|"~     The hypotheses of the present study of Freeman-Sheldon syndrome (FSS) and related conditions~     are: (1) that exercise capacity is lower in FSS patients versus normal controls, and the~     lower exercise capacity is due to changes in the muscles' normal structure and an inability~     of sufficient quantity of the energy molecule to bind to muscle; (2) this muscle problem~     reduces amount of air that can get in the lung and amount of oxygen carried in the blood,~     which then has the effect of increasing heart and respiration rates, blood pressure, and~     deep body temperature, and produces muscle rigidity; (3) the events noted above, when they~     occur during cardiac stress testing, are related to a problem similar to malignant~     hyperthermia (MH) reported in some muscle disorders without use of drugs known to cause MH.~     MH (a life-threatening metabolic reaction that classically is triggered when susceptible~     persons receive certain drugs used in anaesthesia.~   "
133543|NCT01306981|"~     This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery~     for the complications of diabetic retinopathy.~      Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for~     patients. Our hypothesis is that injection into the eye of ranibizumab one week before~     surgery will make the surgery easier, reduce complications and improve outcome.~      In this trial, patients will be randomly allocated to receive either ranibizumab injection~     or a placebo injection of saline. Neither the patient, their surgeon, nor the study~     investigators will know which they have received so that a fair comparison can be made.~   "
133544|NCT01306968|"~     This is a Phase II randomized trial designed to describe the magnitude of change between~     baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological~     tests administered at time points corresponding before and after 10 weeks over observation~     in four groups:~        -  A military population with post-concussion syndrome (mTBI) receiving local standard~          care~        -  A military population with post-concussion syndrome (mTBI) receiving local standard~          care and sham hyperbaric oxygen sessions~        -  A military population with post-concussion syndrome (mTBI) receiving local standard~          care and hyperbaric oxygen at 1.5 atmospheres sessions~        -  A otherwise similar group with PTSD but no history of TBI receiving local standard care~          Differences and variability of the tests will be used for determining the optimum~          primary endpoint(s) for future trial, as well as for refinement of sample size and~          power calculations for these studies. The groups undergoing hyperbaric sessions will be~          assigned to receive HBO2 or sham using a randomized, double blind design.~      Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in~     the United States and who will remain in the military for the entire study period, aged~     18-65 years who have been deployed one or more times to the US Central Command since the~     initiation of Operation Enduring Freedom (October 7, 2001) who either:~        -  have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic~          events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or~          suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR~        -  have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4~          months) symptoms sustained during one or more of those deployments~   "
133628|NCT01305876|"~     Yoga is becoming a part of therapies for children with emotional behavioral disorders. The~     goal is to examine the feasibility and efficacy of yoga sessions for children with emotional~     behavioral disorders at an urban elementary school.~   "
133545|NCT01306955|"~     The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of~     methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A~     total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose~     problem was confirmed with new international criteria of Behcet's disease (ICBD) will be~     randomly assigned into one of the two equal groups of intervention or control. Behcet's~     patients are those with ocular involvement who were under the same cytotoxic treatment with~     cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous~     infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days~     will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5~     mg/kg. After that, all the patients were followed up with no other therapeutic intervention~     by study group. The patients will be visited every 2 months by an ophthalmologist and study~     group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use~     visual acuity, retinal and ocular posterior chamber inflammation index.~   "
133546|NCT01306942|"~     This is a single-arm, open-label, phase I/II study. In the phase I, patients with~     HER2-positive MBC will be treated with paclitaxel, trastuzumab and increasing doses of~     dasatinib to determine the MTD (Maximum Tolerated Dose), DLT (Dose Limiting Toxicity) and~     RPD (Recommended Phase II Dose) of the combination. Once the RPD has been identified, 48~     additional patients will be treated at that dose to evaluate the efficacy and safety of the~     combination in the phase II.~      Primary Objective:~        -  To determine the maximum tolerated dose (MTD) and recommended phase II dose (RPD) of~          dasatinib in combination with fixed doses of trastuzumab and paclitaxel in~          HER2-positive MBC patients (Phase I).~        -  To determine the efficacy, measured by objective response rate (ORR) in HER2-positive~          MBC patients with measurable disease (Phase II).~      Primary Endpoint:~        -  To determine the incidence rate of dose limiting toxicity (DLT) within the first cycle~          of dasatinib in combination with trastuzumab and paclitaxel at each dose level in~          HER2-positive MBC patients (Phase I).~        -  To assess the ORR (defined in the RECIST 1.1 as complete response rate + partial~          response rate) measured by the appropriate radiological test in HER2-positive MBC~          patients with measurable disease (Phase II).~      Sample Size:~      Phase I: following the 3+3 rule, a minimum of 6 and a maximum of 12 patients will be~     recruited.~      Phase II:Assuming 10% drop-out rate, 48 patients are required to enter the study.~      The duration of the study, from first patient visit to last patient visit will be~     approximately 42 months.~   "
133547|NCT01306929|"~     Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in~     movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized~     by chorea (involuntary movements) and a progressive loss of voluntary movement causing a~     substantial functional impairment over time. The study will assess the long-term safety of~     pridopidine and the treatment effects during long-term, open-label treatment.~   "
133548|NCT01306916|"~     Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine~     the prevalence of concurrent thyroid disease applying the current standard of pre-operative~     radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of~     co-existing thyroid disease is advantageous given the well-established increased morbidity~     associated with a second neck exploration. The purpose of this study is to determine the~     prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to~     determine the frequency with which the presence of thyroid disease alters the treatment plan~     for patients with hyperparathyroidism.~      Research Design: This will be a prospective single arm observational study of up to 200~     military health care beneficiaries over the age of 18 years with primary and secondary~     hyperparathyroidism scheduled to undergo parathyroid resection.~      Methodology: Patients will undergo standard pre-operative imaging of the neck including~     ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based~     on the information obtained from history, physical examination, laboratory studies, and~     imaging studies. The number and type of thyroid disease in these patients will be determined~     based on these non-invasive studies (Objective A). A change in the otherwise standard~     treatment will include those patients having partial or complete resections of their thyroid~     glands because: a) the patients would have undergone minimally invasive surgery if not for~     the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland~     parathyroidectomy if not for the results of the imaging studies (Objective B).~   "
133549|NCT01306903|"~     The standard heart-lung machine is a major trigger of systemic inflammatory reactions,~     hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial~     surface and blood-air contact might represent meaningful improvements of the extracorporeal~     technology with respect to organ preservation.~      The aim of this study is the evaluation of potential differences between a minimal~     extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.~   "
133550|NCT01306890|"~     The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs)~     following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.~   "
133551|NCT01306877|"~     The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse~     Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based~     on the primary endpoint.~   "
133552|NCT01306864|"~     The objective of this study is to show that Hemospray is effective in achieving initial~     hemostasis and documenting rate of further bleed when compared to standard of care.~   "
133572|NCT01306604|"~     Niemann Pick Syndrome Type C is a lysosomal storage disorder, caused by a pathological~     overload of cells with unesterified cholesterol as a result of impaired lipid transport into~     the cell, has still the problem of the difficulties of a simple and reliable analysis for~     the primary diagnosis but also for the follow-up of the disease. Therefore the primary aim~     of our project called BioNPC is the development of a new plasma biomarker for the early~     and sensitive diagnosis of the disease. The secondary aim is the testing for clinical~     robustness, specificity and long-term stability of the biomarker.~      Within the scope of the study the investigators would like to collect in the next 12 months~     from about 80 patient's plasma and parallel a simple documentation of the clinical data.~   "
133664|NCT01305408|"~     The primary objective of the study is to determine whether armodafinil treatment, at a~     dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood~     stabilizers for treatment of adults with major depression associated with bipolar I~     disorder.~   "
133553|NCT01306851|"~     The anastomotic leak is one of the most feared complications in abdominal surgery. Certain~     control methods have been described but the incidence of that complication remains high and~     is the first cause of mortality in operations where gut anastomosis are performed.~      With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut~     cicatrization, the investigators started the recruitment of patients to that clinical trial~     in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was~     used, had less anastomotic leaks than that where the fibrin glue was not used.~      The investigators have calculated the number of patients necessaries to have statistical~     significant differences in 200 patients with a rate anastomotic leak expected to be higher~     than 10%.~      The study include all the patients that usually arrive to our surgery department and that~     are expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the~     obese patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.~      The study is randomized, simple blind where the patient does not know if they are in the~     fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or~     radiographic finds relative to the occurrence of an anastomotic leak are recorded.~   "
133554|NCT01306838|"~     Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants.~     Often surgery is needed to remove the dead bowel and create an ostomy (a temporary~     intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb~     food well, and must receive nutrition through the blood stream, i.e. parental nutrition~     (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore,~     giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for~     infants with ostomies.~      Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in~     stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection.~     In addition, the premature intestine has a rapid growth rate. It is likely that the current~     clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet~     their high metabolic needs.~      The investigators hypothesize that increasing dietary fat content by early supplementation~     with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance~     of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use~     of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with~     ostomies.~   "
133555|NCT01306825|"~     Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these~     infections is difficult because of the need of prolonged duration of antimicrobial agents in~     combination with surgical procedure. Moreover, in recent years, a growing resistance pattern~     to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently,~     there is an urgent need for new drugs with high bone penetration for the treatment of those~     infections. The investigators hypothesized that daptomycin allow to achieve high~     concentrations in bone compartments.~   "
133556|NCT01306812|"~     The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent~     criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to~     excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and~     psychosocial risk in relation to depressive symptoms among adolescents The interaction of~     MAO-A genotype and psychosocial risk, in relation to female adolescent criminality~   "
133557|NCT01306799|"~     Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton~     pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the~     development of a type of esophageal cancer. Recently, some studies suggested that taking~     these medications on a long-term basis may affect the bone. Therefore, it is important to~     learn whether these medications may lead to accelerated bone loss so that effective~     preventive measures can be developed for patients who require these medications for~     acid-related conditions. Several studies reported that patients receiving PPIs for many~     years may have increased risk of hip fractures. However, it is unclear whether this is~     because the PPIs cause reduced bone density or whether the increased risk of fractures has~     nothing to do with PPIs and is because patients who require PPIs have other illnesses that~     cause the increased fractures. The purpose of the study is to learn how bone structure and~     bone mass change after long-term PPI use.~   "
133558|NCT01306786|"~     The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori~     eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple~     therapy.~   "
133559|NCT01306773|"~     Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.~   "
133560|NCT01306760|"~     The main aim of this research is to ascertain whether Ketamine would be a more effective~     anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so~     the investigators aim to examine the effect of ketamine on ratings of depressive symptoms,~     the number of required ECT treatments, and the effect of this anaesthetic on memory.~   "
133561|NCT01306747|"~     The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a~     randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500~     chronic pain patients is randomized into either an CPSMP intervention group or a control~     group.~      The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained~     instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors~     are not health professionals but chronic pain patient themselves. The program is highly~     structured and manualized.~      Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and~     well-being. Hence we expect the CPSMP to have an effect on various domains.~        1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls~        2. Illness perception - the cpsmp group will differ from controls in illness perception~          and have higher disease related self-efficacy~        3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care~          utilization (estimated by registerbased data)than controls~        4. Quality of life - the cpsmp group will report higher life satisfaction and less social~          isolation than controls~   "
133632|NCT01305824|"~     The purpose of this study is to determine if PRT-201 when applied to a limited segment of~     your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous~     fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been~     shown to help keep vessels open (patent) when applied to the outside surface of the blood~     vessels (arteries and veins) in AVF patients in a previous study.~   "
133562|NCT01306734|"~     PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing~     planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To~     investigate the impact of hypothermia and circulatory arrest on the coagulation,~     stress-response, and cerebral outcome.~      BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest~     during surgery on the ascending aorta. Two different methods are used either lowering the~     temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash~     cooling. The distribution of hypothermia is expected to be different for the two methods,~     the latter predominantly cooling the body core. The influence on the physiological response~     is expected to vary with the two methods. The surgical procedure and the cooling greatly~     elicit a stress response and the coagulation is profoundly influenced. There can be adverse~     effects on the neurological outcome due to the procedure. The two methods are considered~     equal, but have never been subjected to comparison. The surgery and circulatory changes can~     have a negative influence on the cerebral outcome .~      METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or~     gradient cooling, ten patients in each group.. Patients with severe comorbidities or known~     coagulopathy are excluded. Anesthesia and operation as performed routinely in the~     department. The primary endpoint is duration of cooling, secondary endpoints include~     coagulation parameters (thromboelastography, clot stability), stress response parameters~     (adhesion molecule expression on endothelial cells, oxidative stress analysis, inflammatory~     markers), neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and~     ultrasound imaging of the great vessels for detection of air bubbles. Baseline values are~     obtained for all parameters.~   "
133563|NCT01306721|"~     Primary Objective:~      - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -~     pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -~     pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)~     in patients with seasonal allergic rhinitis (SAR).~      Secondary Objectives:~        -  To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on~          nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily~          activity impairment.~        -  To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.~   "
133564|NCT01306708|"~     The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of~     movement amplitude. It is defined as for etiology, having discordant theories that related~     it to an inflammatory condition or to an algoneurodystrophy process. There is not yet a~     consensus about the best option of treatment. The non-steroidal anti-inflammatories have~     analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of~     prostaglandin synthesis. The antidepressants have been increasingly used in the control of~     chronic pain and the major action mechanism to have the analgesic effect seems to be based~     on inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell~     endings. Literature studies associate the practice of the nerve suprascapular blockade with~     anaesthetics to good results of clinical improvement of the pain, however, so far, no~     clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic~     antidepressants to nervous blockage were registered in the acute treatment of adhesive~     capsulitis.~   "
133565|NCT01306695|"~     Elderly Hispanics have a higher burden of dementia compared to Non-Hispanic Whites.~     Furthermore, Hispanic caregivers tend to have a higher burden of care for their relatives~     with dementia. The objective of this project is to conduct a randomized trial in 160~     Hispanic relative caregivers of persons with dementia comparing the effectiveness of New~     York University Caregiver Intervention to a case management intervention lead by community~     health workers(CHW). This trial will last 6 months. The main outcomes in the trial will be~     changes in depressive symptoms measured with the Geriatric Depression Scale and caregiver~     burden measured with the Zarit Caregiver Burden Scale. This research project will be~     conducted by the Northern Manhattan Center of Excellence in Comparative Effectiveness~     Research for Eliminating Disparities (NOCERED) funded by the National Institute on Minority~     Health and Health Disparities.~   "
133566|NCT01306682|"~     This randomized, placebo controlled trial will evaluate the safety and immunogenicity of~     Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental~     anti-influenza antibody transfer to their newborns and kinetics thereof during early~     infancy.~   "
133567|NCT01306669|"~     Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and~     efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women~   "
133568|NCT01306656|"~     This study will look at the effect of 2 treatment regimens that contain vitamin D in a~     six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will~     be assigned randomly to one of 2 regimens, and will be followed with tests of their blood,~     urine and bones. This study should provide important information on the effect of vitamin D~     therapy in patients with PHPT. In addition, data from this study will guide physicians as to~     how best to treat their patients who have PHPT and vitamin D deficiency.~   "
133569|NCT01306643|"~     The primary objectives of this study is to evaluate the safety and efficacy of idelalisib~     (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma~     (iNHL).~      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg~     twice per day. Treatment with idelalisib can continue in compliant participants for up to~     twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment~     at the completion of 12 cycles of treatment with idelalisib may be eligible for~     participation in a long-term safety extension study of idelalisib.~   "
133570|NCT01306630|"~     This is an open-label, multi-center, dose-finding study of tivozanib administered in~     combination with capecitabine. During the dose-escalation portion, sequential cohorts of~     subjects with advanced solid tumors will be enrolled in order to establish the maximum~     tolerated dose (MTD). If the MTD is not reached, the recommended Phase 2 dose (RP2D) will be~     determined. In the expansion cohort, subjects with locally advanced or metastatic breast or~     colon cancer will be enrolled at MTD (or RP2D) to further evaluate safety and activity of~     this combination in these tumor types.~   "
133571|NCT01306617|"~     The purpose of this study is to evaluate the antiviral activity, safety, and~     pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333~     (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder~     participants with genotype 1 chronic hepatitis C virus (HCV) infection.~   "
133573|NCT01306591|"~     Age-related macular degeneration (AMD) is one of primary blinding eye disease among people~     over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular~     Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available~     low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized~     trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the~     effective therapeutic approach that the majority of patients in China can bear establishing~     a suitable treatment for China.~   "
133578|NCT01306526|"~     Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent~     episodes of complete or partial upper airway obstruction, leading to intermittent oxygen~     deprivation. This results in sympathetic activation and surges in blood pressure, production~     of vasoactive substances, as well as activation of the inflammatory and procoagulant~     pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients~     with coronary artery disease than in the general population. The investigators recently~     showed that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction~     were found to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year~     follow-up epidemiological study, OSA was independently associated with a higher prevalence~     of fatal and non-fatal cardiovascular events among the otherwise healthy general population.~     The investigators further showed that in patients who have undergone primary percutaneous~     coronary intervention for acute myocardial infarction, OSA was an independent predictor of~     future adverse event rates. Despite the observed association between OSA and adverse~     cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In~     this proposal, the investigators aim to elucidate the relationship between OSA and~     composition of coronary atherosclerotic plaques.~   "
133579|NCT01306513|"~     The purpose of this study is to show safety and feasibility to administer patients own~     mesenchymal stem cells to show signs of repair of emphysematous lung tissue~   "
133580|NCT01306500|"~     The purpose of the study is to evaluate the role of gastric lavage in preventing feeding~     problems in babies born through meconium stained amniotic fluid. It is a routine practice in~     many hospitals to perform gastric lavage in all babies born with meconium stained amniotic~     fluid after stabilisation without any supporting evidence. It is believed that meconium is~     an irritant and its presence in stomach causes gastritis and vomiting and hence the basis~     for this practice. Orogastric tube insertion and subsequent gastric lavage is not without~     complications. Potential complications will be prevented and health resources will be saved~     if this procedure is not proven to be beneficial. Therefore the investigators decided to~     study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well~     as incidence of respiratory difficulties in babies born with MSAF.~   "
133581|NCT01306487|"~     The objective is to determine whether a recovery of the microstructures of the foveal~     photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual~     acuity (BCVA) is determined.~   "
133582|NCT01306474|"~     AIM: To study the expression of CD4+CD25+ high regulatory T cells in peripheral blood of~     patients with uveitis and to explore its role in the development of uveitis.~   "
133583|NCT01306461|"~     The purpose of this study is to compare the efficacy and safety of the preservative-free~     fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of~     tafluprost and timolol.~      This study will enroll patients who have ocular hypertension or glaucoma.~      The study schedule includes seven visits to the study site and three stages:~        -  washout of 5 days to 4 weeks depending on current glaucoma medication (if any)~        -  6-month study treatment period~        -  1-3 weeks post-study period~   "
133584|NCT01306448|"~     The study will assess the safety of the vibrating capsule in healthy volunteers first and~     than for constipation relief constipated individuals.~   "
133585|NCT01306435|"~     Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness~     and poor quality of live. The results are very consistent about the benefits of laser and~     exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To~     investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function,~     range of motion, muscle strength and quality of life of patients with knee osteoarthritis.~      Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis~     (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and~     Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion,~     muscle strength and quality of life on three occasions: before starting treatment~     (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion~     of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on~     March 1 and the laser was applied in the other, only the exercises.~   "
133586|NCT01306422|"~     The objective of this clinical study was to assess the safety, tolerability, efficacy~     (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified~     extract (H.g.PE), when consumed twice-daily for 2 or 15-days.~   "
133587|NCT01306409|"~     The purpose of this study is to gain information on reticulocyte neocytolysis in patients~     treated with ESA with regard to different types of ESA.~   "
133588|NCT01306396|"~     The aim of the present study is to find out if a dietary intervention mainly focusing on~     fructose reduction has a preventive effect on the development and progression of NAFLD and~     the metabolic syndrome in overweight children.~   "
133589|NCT01306383|"~     SODISWATER was a health impact assessment study investigating the effect of sunlight to~     inactivate microbial pathogens in drinking water. This study was carried out by observing~     whether children younger than 5 years old who drink solar disinfected water were healthier~     than those who did not. Health was measured by how often the children had diarrhoea or~     dysentery.~      Caregivers for the participants were given plastic bottles to place in the sun, water~     samples were then collected from these plastic bottles to be analyzed. They were also~     requested to fill in diarrhea diaries.~      TESTABLE RESEARCH HYPOTHESES:~      Health Impact Assessment: Children who use solar disinfected water will have:~      (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth~     rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden~     (g) increased school attendance~   "
133633|NCT01305811|"~     This unblinded Phase II clinical trial tested the effects of individualized acupuncture~     treatments offered in extant acupuncture practices in the community; practitioners had at~     least 5 years of experience plus additional training provided by the study. Veterans with~     diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly~     acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly~     acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6~     months. The primary outcome is the SF-36 physical component scale score (SF-36P).~   "
133590|NCT01306370|"~     Objectives:~      a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the~     blood losses with respect to the habitual haemostasia in patients with arthroplasty total of~     knee.~      Secondaries: To assess the treatment safety. To perform a cost- analyses.~      Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups:~     Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i~     Teixits de Catalunya), tranexamic acid and habitual haemostasia.~      Nº of participant centres: 1. Random allocation will be centralised.~      Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain~     system.~      Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery~     wound, pre and post-operative haemoglobin, units of blood transfused, post-operative~     mortality, days of hospital stay, safety of interventions assessed.~      Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate~     a 20% difference in the post-operative blood losses between the treatments assessed and the~     habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20%~     of withdrawals.~      Statistical analysis: The investigators will perform a comparison of outcomes through the~     t test, the Mann-Whitney test of chi square, depending of the evaluated outcomes,~     quantitative or ordinals or qualitative, respectively. The software used will be Statistical~     Package for the Social Sciences (SPSS) version 17.~   "
133591|NCT01306357|"~     The purpose of this strictly observational, prospective, longitudinal study is to evaluate~     with sufficient precision the rate of overall treatment compliance from one year to 3 years~     of follow-up of the patients.~      Somatotropin is indicated in the long-term treatment of children with growth retardation~     related to a deficiency in secretion of growth hormone and in the long-term treatment of~     growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are~     the two indications of Zomacton® 4 mg and 10 mg injection solution.~      The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the~     administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved~     for the administration of Zomacton® 10 mg), allows the product to be administered by~     percutaneous transjection (needle-free) and can be used by the child directly or by the~     family after an initial training.~      In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a~     follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the~     compliance and duration of use of the device.~      The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device~     is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90~     patients will be treated. In the cohort studied the patients will be followed-up for 1 year~     at least and for 3 years at the maximum.~      The rate of treatment compliance will be evaluated according to the ratio of the actual~     duration of administration over the total duration recommended by the physician during the~     observation period.~   "
133592|NCT01306344|"~     1. A qualitative descriptive design.~        2. A phenomenologic approach to investigate the meaning of the ward round.~        3. Interviews of patients, nurses and physicians.~        4. A Master thesis.~   "
133593|NCT01306331|"~     This is a research study of a new experimental vaginal gel known as a spermicide, a birth~     control method that kills sperm. This spermicide, called Amphora™, is being compared to a~     commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly~     abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study will determine if~     this product prevents pregnancy when inserted into the vagina before intercourse.~   "
133594|NCT01306318|"~     The primary objective of this study is to compare the bioavailabilities of a single fixed~     dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the~     bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human~     adult male subjects under fasting conditions.~   "
133595|NCT01306305|"~     A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine~     Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines~   "
133596|NCT01306292|"~     This is an intra-subject crossover comparative safety study to evaluate the effect of~     intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.~   "
133597|NCT01306279|"~     Given the treatment burden and excess morbidity and mortality associated with acute~     infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved~     in the origins of an infective exacerbation and the response to antibiotics is vital to~     improving long-term outcomes in CF.~      This study will examine 3 areas of interest in CF exacerbations.~        1. Bacterial biodiversity and its clinical significance~        2. The role of bacteria which are able to rapidly mutate (hypermutators)~        3. Inter-bacterial communication and its role in infective exacerbations~      Study Hypothesis 1~      Increased microbiological diversity represents a balanced community of bacteria. The~     presence of a diverse population of bacteria in CF infections therefore predicts a better~     outcome for treatment than when a population consists of a small number of more virulent~     organisms.~      Study Hypothesis 2~      Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas~     aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under~     stress, such as during antibiotic treatment or during an infection. They are, however,~     weaker organisms because of the multiple mutations they have undergone. Their presence does~     not relate to clinical outcome but may be associated with the emergence of antibiotic~     resistance.~      Study Hypothesis 3~      Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding~     to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of~     bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective~     growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill~     this population of bacteria and QS molecule levels drop in the lung, patients recover from~     infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels~     to remain elevated and patients to have prolonged infections.~   "
133598|NCT01306266|"~     The purpose of the study is to determine the effectiveness of rizatriptan for treating~     attacks of chronic post-traumatic headache.~   "
133599|NCT01306253|"~     This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine~     Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.~   "
133629|NCT01305863|"~     Researchers are actively seeking a way to coat the inside of a synthetic graft so that it~     more closely resembles native vessels and therefore has low thrombogenicity and low~     incidence of stenosis. Using a biological coating comprised of autologous stromal cells~     derived from the patient's own adipose tissue is a logical solution. Considerable~     experimental evidence exists that such a coating is relatively non-thrombogenic and improves~     long-term graft patency.~      The Company's TGI Cell Isolation System (CIS) for isolating and concentrating~     adipose-derived stromal cells (ASC) can be used to fill the pressing medical need for~     small-diameter synthetic vascular grafts. The TGI CIS enables the user to prepare a stem~     cell-based biological coating from adipose tissue liposuctioned from the patient. The cells~     derived from the adipose tissue are then sodded onto the internal lumen of the vascular~     graft to improve long term patency.~   "
133600|NCT01306240|"~     Term and near term newborns can present acute respiratory distress syndrome (RDS).~     Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen~     treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for~     term and near term newborns is unknown. The purpose of this study is to compare surfactant~     treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41~     weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint~     is survival with no oxygen treatment at 72 hours of life. The secondary endpoints are:~     death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension,~     inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment,~     mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen~     treatment at 28 days of life, hospitalization duration and treatment strategy cost.~   "
133601|NCT01306227|"~     Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental~     impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether~     L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.~      The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less~     than 32 WG with THOP.~      The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the~     Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen~     therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus,~     shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular~     hemorrhage, retinopathy of prematurity, deafness.~   "
133602|NCT01306214|"~     This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with~     metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the~     use of insulin in this population would provide significant new information for the BI 10773~     use and would offer a potential new therapeutic option in this population.~   "
133603|NCT01306201|"~     Data collected from this study will be used to evaluate the performance of a monitoring~     algorithm.~   "
133604|NCT01306188|"~     The T and B cells repertoire diversity represent one of the immune defence level which~     controls the integrity of the organism and determines its ability to recognize and control~     infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR~     diversity could permit to better understand how lymphopenia act on overall survival and to~     improve detection of high risk patients who could benefit of adapted therapies for better~     care.~   "
133605|NCT01306175|"~     The objective of the study is to investigate the relative bioavailability of digoxin after~     concomitant multiple oral administration of BI 10773 and a single dose of digoxin in~     comparison to digoxin given alone to healthy male and female subjects.~   "
133606|NCT01306162|"~     The objective of the study is to assess the relative bioavailability of a single dose of~     dabigatran after concomitant multiple oral administration of dronedarone with the aim to~     investigate whether and to what extent the P-gp inhibitor dronedarone affects~     pharmacokinetic parameters of dabigatran when administered to healthy subjects~   "
133607|NCT01306149|"~     The aims of this study are~        1. To evaluate the natural history of plasma concentrations and renal and peritoneal~          clearances of small water-soluble uremic retention molecules (URM), 'middle molecules',~          and protein bound URM in incident peritoneal dialysis (PD) patients.~        2. To evaluate the natural history and determinants of the generation rate of URM~          originating from bacterial protein fermentation in PD patients.~        3. To evaluate the natural history of biochemical parameters of mineral metabolism in~          incident PD patients.~   "
133608|NCT01306136|"~     The purpose of this project is to examine the feasibility of a culturally adapted, manual~     based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto~     Ricans with posttraumatic stress disorder~   "
133609|NCT01306123|"~     The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal~     Spray as compared to an IM injection of cyanocobalamin (European reference product).~   "
133610|NCT01306110|"~     The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers~     in patients with diabetes.~   "
133611|NCT01306097|"~     Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and~     recurrent diarrhea in 6 to 36 months age children in Bandarabbaas~   "
133612|NCT01306084|"~     Background:~      - Viral infections are an important cause of illness and death in hospitalized patients as~     well as outpatients. New strains of viruses may appear and infect both healthy people and~     those with weak immune systems. A better understanding of these new virus strains may help~     to control and prevent these infections. In particular, some viral infections that are less~     problematic in healthy persons can be life threatening in persons with weak immune systems,~     and viruses may be able to evolve more rapidly in persons with weak immune systems and~     therefore develop resistance to existing treatments. Researchers are interested in~     collecting samples and information from otherwise healthy persons or persons with weak~     immune systems to study the effects of viruses and their development.~      Objectives:~      - To collect samples and data from individuals who have been exposed to or have contracted~     viral infections.~      Eligibility:~        -  Individuals of all ages who have been diagnosed with a viral infection are suspected to~          have a viral infection, or have been in close contact with someone with a suspected or~          actual viral infection that is of interest to investigators in the Laboratory of~          Infectious Diseases.~        -  Healthy persons and persons with weak immune systems (immunocompromised individuals)~          are eligible to participate.~      Design:~        -  Participants will be initially screened with a review of the medical records and if~          eligible a history and physical will be performed.~        -  Study procedures may include blood, stool, urine, saliva, or nasal fluid samples, and~          throat and genital swabs. For participants who have a specialized sample collection~          procedure as part of their medical care (e.g., spinal tap, bronchoscopy, liver biopsy),~          researchers may collect leftover samples from the clinical laboratory for testing.~        -  Samples may be collected up to four times per week during the first 2 weeks after~          enrollment in the study, and then as many as two times per week for up to 1 year. The~          number of study visits will be determined by the study researchers, and will depend on~          the virus being studied. Some participants may be asked to continue providing samples~          for longer than 1 year if there is concern for recurrence or relapse of the infection~          or if the study researchers feel that there are other reasons where it would be~          important to follow the viral infection.~        -  For otherwise healthy persons who have been exposed to a viral infection, an initial~          specimen will be collected and then up to three additional specimens may be collected~          over 1 year.~        -  Treatment will not be offered under this study....~   "
133630|NCT01305850|"~     This is a prospective, randomized, placebo controlled, multi-center clinical trial to~     determine whether aliskiren or aliskiren plus losartan or enalapril plus losartan effects on~     peritoneal membrane transportation.~   "
133631|NCT01305837|"~     The purpose of this study is to determine whether cyclic oral methylprednisolone once every~     month has an effect on the intrathecal inflammation in patients suffering from progressive~     multiple sclerosis.~   "
133634|NCT01305798|"~     The goal of this project is to see if behavioral nudges will increase an individual's~     likelihood of participating in a biometric screening. The behavioral nudges under~     consideration are assigning preselected time-slots, encouraging subjects to make an active~     choice, and sending reminders.~   "
133613|NCT01306071|"~     Background:~      - Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end~     stage liver disease and liver cancer. Although significant progress has been made recently~     in hepatitis B therapy, current knowledge about how to manage the infection is limited~     because most treatment trials involve 1 to 2 years of therapy at most, even though most~     patients require treatment of much longer duration for optimal long-term outcome. To improve~     current knowledge on the disease and long-term disease progression, the Hepatitis B Research~     Network is collecting health and disease information from individuals who have been~     diagnosed with hepatitis B.~      Objectives:~      - To study individuals with hepatitis B and identify factors that affect the way the disease~     progresses.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with hepatitis B.~      Design:~        -  Participants will be screened with a physical examination and medical history. Health~          information will be collected through questionnaires and surveys on health behaviors,~          and family history of liver disease. Participants will also provide blood samples, and~          those who have had a liver biopsy within the past 2 years or have one during the course~          of the study will provide biopsy material for further study.~        -  Information will be collected during a series of study visits. Each visit will take~          approximately 1 hour. During the first year, participants will have study visits 12~          weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years,~          participants will have a study visit approximately every 24 weeks (6 months) until the~          end of the study.~        -  Additional visits will be required of women who are pregnant when enrolled in the study~          or become pregnant during the course of the study.~        -  Participants whose hepatitis B status changes during the course of the study (for~          example, a flare of disease activity) may be asked to return for more frequent visits.~   "
133614|NCT01306058|"~     Background:~      Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular~     carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by~     slowing the spread of cancer cells, but it does not fully prevent the cancer from growing~     again. Researchers are interested in combining sorafenib with the experimental drug TRC105,~     which has been designed to block the growth of blood vessels that lead to tumor growth, in~     order to determine whether this drug combination stops tumor growth and reduces tumor size~     better than sorafenib alone.~      Objectives:~      To determine the safety and effectiveness of the combination of sorafenib and TRC105 as a~     treatment for hepatocellular cancer that has not responded to other treatments.~      Eligibility:~      Individuals at least 18 years of age who have been diagnosed with hepatocellular cancer that~     has not responded to other treatments, and who are not considered to be candidates for liver~     transplantation. Patients cannot be receiving anticoagulant therapy with the exception of~     low dose aspirin. No history of bleeding problems or peptic ulcer disease.~      Design:~      Participants will be screened with a full medical history and physical examination, blood~     and urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide~     previously collected tumor tissue for study. An examination of the esophagus to look for~     problems with blood vessels will be completed in patients with a history of cirrhosis.~      Participants will receive sorafenib tablets twice every day, in the morning and at night,~     with a full glass of water.~      Participants will receive TRC 105 infusions once every two weeks on days 1 and 15 of a 28~     day cycle.~      At each visit during the first cycle, participants will have a physical examination and~     blood tests. Participants will continue to have blood tests and a urine test every cycle to~     monitor the effects of treatment, including tests of kidney function. Participants will have~     imaging studies after every two cycles to evaluate the results of treatment, and may also~     provide tumor samples for study.~      Treatment will continue as long as the tumor does not grow and side effects remain~     tolerable.~   "
133615|NCT01306045|"~     Background:~      - The current standard of care for advanced lung cancer and cancers of the thymus consists~     primarily of chemotherapy treatment. The drugs used for chemotherapy depend on the~     classification of the cancer in different categories that are based on the appearance of the~     cancer in the microscope. Though this approach has been proved to be useful in some ways,~     the survival rates of individuals with lung cancer and cancers of the thymus are still very~     poor. Recent research has shown that several genetic abnormalities play an important role in~     the development and growth of lung cancer and cancers of the thymus, and that it is possible~     to improve treatment success rates with drugs that specifically target some of the abnormal~     genes. Researchers are interested in determining whether it is possible to analyze the genes~     of patients with lung cancer and cancers of the thymus in order to provide personalized~     treatment with drugs that target the specific gene abnormalities.~      Objectives:~      - To evaluate the effectiveness of genetic analysis in determining targeted therapy for~     individuals with advanced non-small cell lung cancer, small cell lung cancer, and thymic~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with either lung cancer or a~     cancer of the thymus that is not considered to be curable with the use of surgery or~     radiation therapy.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies. Participants will have a tumor biopsy~          or provide previously collected tumor tissue for study.~        -  Based on the results of the tumor biopsy study, participants will be separated into~          different treatment groups:~        -  Participants with EGFR gene mutation will receive a drug called erlotinib, which~          inhibits a protein called EGFR that is thought to be a key factor in the development~          and progression of some cancers.~        -  Participants with KRAS, BRAF, HRAS, or NRAF gene mutations will receive a drug called~          AZD6244, which inhibits a protein called MEK that is thought to be a key factor in the~          development and progression of some cancers.~        -  Participants with PIK3CA, AKT, or PTEN gene mutations will receive a drug called~          MK-2206, which inhibits a protein called AKT that is thought to be a key factor in the~          development and progression of some cancers.~        -  Participants with KIT or PDGFRA gene mutations will receive a drug called sunitinib,~          which inhibits some proteins that are thought to be key factors in the development and~          progression of some cancers, including kidney cancer.~        -  Participants who have ERBB2 gene mutation or amplification will receive a drug called~          lapatinib, which inhibits some proteins that are thought to be key factors in the~          development and progression of some cancers, including breast cancer.~        -  Participants who do not have any of the genetic abnormalities described above will be~          offered different options for treatment, including standard of care chemotherapy or~          treatment with investigational agents in a different research protocol.~        -  After 6 weeks of treatment, participants will have imaging studies to evaluate the~          status of their cancer. Treatment will continue as long as participants tolerate the~          drugs and the disease does not progress.~        -  Participants who benefit from the first treatment but eventually develop resistance and~          progression of their cancer will be offered the chance to have a second tumor biopsy~          and undergo a different treatment for their cancer.~   "
133616|NCT01306032|"~     Background:~      - The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing~     deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment~     drug that works by causing DNA damage in cells, including cancer cells, resulting in cell~     death. However, because cyclophosphamide has strong and unpleasant side effects, researchers~     are interested in finding drugs that can be given in combination with cyclophosphamide that~     will allow a lower dose of cyclophosphamide to be given with similar effects. The~     combination of ABT-88 and cyclophosphamide may be an effective treatment for some types of~     cancer, such as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that~     often do not respond to standard therapies.~      Objectives:~      - To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and~     breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2)~     BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian~     tube cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy);~     or (3) low grade non-Hodgkin's lymphoma.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies. Participants will be divided into two~          groups with different treatment subgroups.~        -  Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or~          ovarian high-grade serous carcinoma, or fallopian tube cancer~        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or~          cyclophosphamide alone.~        -  Participants will take the study drug by mouth once a day for 21-day cycles of~          treatment, and will keep a diary to record drug doses and any side effects.~        -  Participants will have clinic visits with blood and urine tests, imaging studies, and~          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all~          other cycles.~        -  Group 2: Participants who have triple-negative breast cancer or non-Hodgkin's lymphoma~        -  Participants will receive either the combination of ABT-888 and cyclophosphamide, or~          cyclophosphamide alone.~        -  Participants will take the study drug by mouth once a day for 21-day cycles of~          treatment, and will keep a diary to record drug doses and any side effects.~        -  Participants will have clinic visits with blood and urine tests, imaging studies, and~          other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all~          other cycles.~        -  Participants receiving only cyclophosphamide who show signs of disease progression~          after tumor imaging studies can receive the combination of ABT-888 with~          cyclophosphamide.~        -  Treatment will continue as long as participants tolerate the drugs and the disease does~          not progress.~   "
133617|NCT01306019|"~     Background:~        -  X-linked severe combined immunodeficiency (XSCID) is caused by a genetic abnormality in~          the IL2RG gene that affects the growth and development of immune cells such as white~          blood cells. Individuals with XSCID have difficulty fighting infections, which may lead~          to chronic or severe illness and death. The primary treatment for XSCID is replacement~          of the patient s immune system with a normal immune system through a bone marrow~          transplant. The best outcomes in transplant patients are achieved when the bone marrow~          comes from a sibling, but parents and matching unrelated donors can provide bone marrow~          for transplant as well. However, because these transplant procedures are not always~          effective, researchers are studying gene transfer treatment as an approach to treating~          XSCID.~        -  Lentiviral gene transfer treatment uses good genes to replace defective genes. A~          lentivirus is a virus that has been modified to carry corrected genes into the blood~          through corrected stem cells. By collecting an individual s stem cells and modifying~          them with a lentivirus, the gene-corrected cells can be returned into the blood to help~          produce normal healthy immune cells. Gene transfer treatment with lentivirus vector has~          been used in humans but has never been studied in patients with XSCID.~      Objectives:~      - To determine the safety and effectiveness of lentiviral gene transfer as a treatment for~     children and adolescents with X-linked severe combined immunodeficiency.~      Eligibility:~      - Children and adolescents between 2 and 20 years of age who have XSCID related to a defect~     in the IL2RG gene and who are not currently under treatment with strong immune-modulating or~     chemotherapy drugs.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and bone marrow samples to collect stem cells for the procedure.~        -  Participants will be admitted to the National Institutes of Health Clinical Center 11~          to 12 days before receiving gene-corrected blood stem cells.~        -  Participants will receive palifermin for 3 days, followed by busulfan for 2 days.~          Palifermin will help prevent side effects from busulfan, and busulfan will help~          suppress the immune system in preparation for the gene transfer. Participants will have~          regular blood tests during this preparation period.~        -  Participants will receive a transfer of their corrected blood stem cells about 36 to 48~          hours after the second dose of busulfan. The cells will be injected over 5 to 10~          minutes under close monitoring.~        -  The day after the transfer, participants will have 3 more days of palifermin.~        -  Participants will remain in the hospital for several weeks, possibly as long as 6~          weeks, while the response to treatment is monitored.~        -  Participants will continue to be monitored for immune function and possible side~          effects after leaving the hospital, and will be followed for up to 15 years after the~          procedure to evaluate the long-term effects of gene transfer therapy. The monitoring~          will involve regular physical exams and blood samples.~   "
133618|NCT01306006|"~     The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts~     exclusively on children below 12 months of age; children who have reached 12 months of age~     are no longer entitled to vaccines through the EPI program. This has affected the measles~     vaccination coverage, approx. 30% of the children in the rural area do not receive measles~     vaccine (MV).~      Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on~     survival, reducing mortality by approximately 50% - far more than can be explained by~     prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on~     survival, and the current policy may have important consequences for overall child~     mortality.~      To test the implications of the current policy of only vaccinating children below 12 months~     of age, the investigators will conduct a cluster randomized trial, in which children will~     receive their vaccines according to the current national EPI policy (National policy) or~     receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).~      The investigators hypothesise that among children enrolled after 12 months of age, mortality~     is 50% lower in children randomised to receive MV compared with children randomised to~     follow the national policy and not receive MV.~   "
133619|NCT01305993|"~     The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.~   "
133620|NCT01305980|"~     The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.~   "
133621|NCT01305967|"~     The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung~     Cancer.~   "
133622|NCT01305954|"~     The primary purpose of this study is to measure the association between baseline expression~     of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in~     patients with breast cancer. Patients with Stage I-IV breast cancer will be included and~     myelosuppression will be assessed after the first cycle of chemotherapy via measurement of~     an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study~     subjects will also be asked to complete a brief health behaviors questionnaire to gather~     information on other relevant variables.~   "
133623|NCT01305941|"~     Purpose: This study is a single-arm, open-label phase II clinical trial testing the~     hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective,~     safe, and tolerable among patients with HER2-positive breast cancer brain metastases. Once~     enrolled, patients will receive everolimus PO daily in combination with weekly intravenous~     (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the~     time of progression, patients will come off study.~      Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has~     metastasized to the brain.~   "
133624|NCT01305928|"~     Post-discharge support is a key component of effective treatment for hospitalized smokers,~     but very few hospitals provide it. Linking hospitalized smokers with free, proactive tobacco~     quitlines is an ideal way to provide supportive contact at discharge, because quitlines are~     effective and cost effective for smoking cessation. Many hospitals are beginning to~     fax-refer smokers to quitlines at discharge. Fax referral is convenient and is part of the~     current culture of medical communication channels. However, less than half of fax-referred~     smokers are successfully contacted and enrolled in quitline services. Warm hand-off is a~     novel approach to care transitions in which health care providers directly link patients~     that have substance abuse and mental health problems with specialists, using face-to-face or~     phone transfer. Warm hand-off achieves very high rates of treatment enrollment for these~     highly vulnerable groups.~   "
133625|NCT01305915|"~     As the number of women who survive breast cancer continues to grow, more attention is being~     paid to their quality of life and the disease's long-term effects. The transition from~     patient to survivor, also termed the re-entry transition, can be a very difficult and~     stressful time. A brief psychosocial intervention delivered at this important transition~     time may address the challenges that women face at re-entry, facilitating greater adaptation~     and more optimal recovery. The purpose of the proposed RCT is to test the acceptability and~     effectiveness of a single-session group psychoeducational intervention led by a~     multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design~     (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret~     Hospital in Toronto. Participants will be recruited while completing their adjuvant~     radiotherapy and those who agree to participate will complete the baseline questionnaire~     package (T0). They then will be randomized to receive either: (1) standard print material~     (CRL group n=220); or (2) standard print material and a single session group~     psychoeducational intervention (INT group n=220). Two weeks following randomization,~     participants in the CRL group will be given the Getting Back on Track: Life after~     Treatment booklet (current standard care), which includes information on the new health~     care team, physical side-effects, diet and exercise, emotional and social needs and~     returning to everyday life. Participants in the INT group will receive the same booklet and~     will also attend a 2- hour psychoeducational group session facilitated by a~     multidisciplinary team. Participants in both groups will be asked to complete the~     questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the~     completion of cancer treatment. Participants in the INV group will also be asked to rate~     their satisfaction with the class and provide feedback on the content. The proposed~     intervention will be one of the few clinical interventions designed to address the service~     gap in helping women to make the transition from patients to survivors by using a~     single-session psychoeducational group intervention.~   "
133626|NCT01305902|"~     The purpose of this pilot study is to estimate the effect size of a contingency management~     procedure that reinforces walking at rates consistent with the American College of Sports~     Medicine recommendations of 10,000 or more steps per day in older adults. We expect that~     participants randomized to the contingency management intervention will increase walking to~     a greater degree than those assigned to a standard care condition.~   "
133627|NCT01305889|"~     The focus of this study is to gather preliminary data regarding the effects of a~     psychological therapy—Problem Solving Therapy—and an antidepressant medication—sertraline—on~     1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of~     cognitive function in subjects with late life major depression (LLMD). This research goal~     will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary~     outcomes will be change in CP, change in BDNF, and change in cognitive measures from~     baseline to the end of 12 weeks of either therapy. We will also examine predictors of~     treatment outcome including severity of executive dysfunction, baseline BDNF concentrations,~     and baseline CP measures. The baseline neuropsychological testing, brain imaging, and~     depression assessment will be obtained in a companion study (PI S. Mackin; CHR~     #H42689-32681-01) that is IRB approved and is already in progress. In the current study a~     baseline serum BDNF level will be added to Dr. Mackin's protocol. Patients will then receive~     either 12 weeks of Problem Solving Therapy or antidepressant treatment with sertraline. Both~     treatments are evidence based and commonly administered in our clinic. Outcome variables~     will be measures of depression severity, the BDNF serum concentration, cerebral perfusion~     using a MRI arterial spin labeling (ASL) technique and cognitive changes in memory and~     executive dysfunction. This is a preliminary or pilot study. The primary objectives are to~     determine if the methods appear feasible and to determine if change in BDNF or CP occur~     after treatment and secondarily to determine if there are changes in cognitive functioning.~     The study is not powered to show differences between treatments. The hypotheses are 1) PST~     will result in increased perfusion in frontal regions of the brain but that frontal~     perfusion will not change with sertraline; 2)sertraline will result in an increase in BDNF~     but PST will not. Change in cognitive measures of memory, learning, and executive~     dysfunction will be examined on an exploratory basis.~   "
133689|NCT01305083|"~     This randomized, double blind, placebo controlled, multicentric, clinical study will assess~     the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile~     dysfunction(ED).~   "
133635|NCT01305785|"~     The AMIS Plus national registry collects and analyzes data on patients with acute myocardial~     infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is~     placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and~     treatment of acute coronary syndrome. The AMIS Plus data gathered are important for~     assessing guidelines, improving compliance with guidelines in clinical practice,~     investigating patient groups not extensively studied in large randomized trials, quality~     assurance as well as the continuous improvement of therapeutic strategies based on a large~     database.~   "
133636|NCT01305772|"~     The purpose of this study was to identify which cancer-related genes are turned on or turned~     off in order to determine how well a patient will respond to the study drug, panitumumab.~     Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects~     that receive surgery followed by therapy and subjects that receive radiation therapy without~     surgery.~      Subjects entering this study had locally advanced disease that can be treated with surgery~     and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis~     prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of~     consent, a biopsy was required to participate in this trial.~   "
133637|NCT01305759|"~     The project runs as a Ph.d. project at the Faculty of Health Sciences- University of~     Copenhagen.~      In Denmark the investigators operate around 16.000 artificial hips and knees yearly, mainly~     due to osteoarthritis. The numbers has increased with 13,9% for hips and 50,7% for knees in~     the period 2004 to 2007. In 10% of the cases, or approximately 1.600 patients, the patient~     is younger than 50 years - mid-life, working, socially active and sexually active. The~     investigators have a tendency within in the orthopedic society to mainly focus on the~     technological aspects of the procedure and tend to forget that this is a key event for the~     patient with widespread consequences for the patient and his future life.~      Hip- and knee arthroplasties is without no doubt two of the most important and successfully~     surgical procedures ever introduced. The economical cost for osteoarthritis treatment has~     exploded in the developed world over the last decade, with a yearly growth on 8%.~      Because of the limited lifetime for an artificial hip or knee, this treatment can be~     unfortunate for the young patient. This has over the last years led to an increased interest~     for joint preserving surgery. Over the last twenty years it has been tried to delay the time~     for total hip arthroplasties for patients with hip dysplasia with the aid of Ganz osteotomy.~     Since this technique was introduced back in 1988, the research on the topic has had its main~     focus on optimizing the operation technique. So as with surgery with artificial hip or knee~     the investigators have a lack of knowledge regarding the social, work related, psychological~     and sexual aspects of this treatment.~      Purpose The consequences of an artificial hip or knee joint regarding patients' social-life,~     work, psychological and sexual aspects gain very little attention international. The~     investigators apply most of our research funds exclusively to research and development of~     the surgical track and procedure, new prosthesis designs or coatings. The investigators find~     this study highly relevant because this kind of studies has been preformed for several~     chronic diseases but not osteoarthritis and its treatment.~      With this study the investigators wish to examine the social, work related, psychological~     and sexual aspects of end stage osteoarthritis. This will lead the way for improved~     information to the patient and improve the surgeons' possibilities for chosen the correct~     time for surgery.~   "
133638|NCT01305746|"~     The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.~   "
133639|NCT01305733|"~     The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce~     oxycodone consumption during the first 48 postoperative hours in patients undergoing total~     knee arthroplasty (TKA).~   "
133640|NCT01305720|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral and mesenteric oxygenation in newborn infants. Using this~     technique the investigators investigated the effect of mydriatic eye drops on cerebral and~     mesenteric oxygenation in preterm infants~   "
133641|NCT01305707|"~     OBJECTIVES:~      To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy~     associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive~     relapse.~      METHODS:~      Demographic and clinical variables will be collected and side effects scales and~     neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both~     groups in one year (primary variable); time without relapse. Main variable of security:~     occurrence of side effects and neurocognitive performance.~      DESIGN: Randomized controlled clinical trial.~      SAMPLE:~      104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with~     a course of bilateral ECT. They will be randomized to two groups of treatment.~      SETTING: Psychiatry Department at Bellvitge University Hospital.~      ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of~     regression.~   "
133642|NCT01305694|"~     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous~     administration of bone marrow derived mesenchymal stem cells from related donor to patients~     with relapsed/refractory aplastic anemia.~   "
133643|NCT01305681|"~     The primary objective of our study is to examine characteristics of bacteria that are~     discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric®~     catheters for self intermittent catheterization. The investigators hypothesize that the~     hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce~     clinically significant urinary tract infections in patients with neurogenic bladder compared~     to a similar population using standard catheters.~      Secondary outcomes will be comparing the incidence of clinical urinary tract infections~     between patients that use standard catheters and those that use LoFric catheters.~      Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be~     assessed.~   "
133644|NCT01305668|"~     Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis~     and pulmonary emphysema phenotypes) with a different clinical presentation.~      The phenotype evaluation in COPD patient (trough clinical, functional and radiographic~     parameters) could influence final results in pharmacologic and non-pharmacologic management~     of the disease.~      The aim of our study is to investigate whether COPD patients with different disease~     phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.~   "
133645|NCT01305655|"~     Early intervention in children and adolescents who experience delayed MTX-clearance and~     renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses~     MTX to non-toxic metabolites to avoid life threatening complications.~   "
133646|NCT01305642|"~     To analyze the weight gain of very low birth weight infants during a minimum period of three~     weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been~     individually fortified.~   "
133663|NCT01305421|"~     ICU patients do experience extubation failure. Guidelines rarely include muscle strength~     criteria. Prior work indicates that grip strength is a reliable surrogate for muscle~     strength. The purpose of the study is to assess the success rate of mechanical ventilation~     weaning based on the grip test.~   "
133647|NCT01305629|"~     The proposed study uses a randomized controlled experimental design to evaluate the efficacy~     of a brief intervention using spiritual self schema (3S+) counseling to simultaneously~     target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV~     positive older adults (age 50+), relative to an attention control condition. Participants~     will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for~     the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12~     sessions of education about HIV health and the associated with alcohol and drug use that~     will serve as an attention-control.~   "
133648|NCT01305616|"~     To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry~     (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.~   "
133649|NCT01305603|"~     Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to~     investigate, in what way a known volume of local anesthetic injectate will be distributed in~     the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators~     compare the anatomical distribution of the local anesthetic injectate in the TAP when~     performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators~     also want to compare the spread of anesthetized frontal dermatomes when performing an~     ultrasound-guided classical TAP block and a Dual TAP block.~   "
133650|NCT01305590|"~     In anticipation of a pilot study incorporating behavioral economics into the treatment of~     infectious diseases, we will conduct a survey with HIV/AIDS patients at the Ponce Clinic~     (Infectious Disease Program of Grady Memorial Hospital, Emory University School of Medicine,~     Atlanta, GA).~   "
133651|NCT01305577|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
133652|NCT01305564|"~     The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center~     study which is intended to provide evidence of safety of the placement and retrieval of the~     Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption~     to protect against pulmonary embolism (PE).~   "
133653|NCT01305551|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and~     Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose~     combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in~     Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.~   "
133654|NCT01305538|"~     The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared~     to placebo in the treatment of patients with post-herpetic neuralgia (PHN).~   "
133655|NCT01305525|"~     This is a prospective non-interventional 24 month post implant registry. Any patient that~     receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for~     enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.~      Patients will be enrolled post-implant and followed for 24 months. Data are collected at~     enrollment (within 30 days of device implant), and routine care follow-up visits at 3~     months, 6 months, 12 months, 18 months and 24 months.~   "
133656|NCT01305512|"~     Evaluation of pharmacokinetic profile of SPARC1028~   "
133657|NCT01305499|"~     This research is being done to help us learn how to best use new drugs which may be active~     against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine)~     and entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also~     shown promise in AML. Entinostat has undergone early testing in patients with MDS and AML.~     It has decreased the blast count in some patients' blood and bone marrow and has improved~     the blood counts in some patients. The combinations of these two classes of drugs are well~     tolerated and appear to work well together in laboratory tests.~      A recent study at Johns Hopkins University administered 5AC and entinostat in an overlapping~     schedule to patients with myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia~     (CMMoL), and AML. The impressive results from this study have led to another phase II trial~     to further examine this drug combination versus 5AC alone in these patients. In this study,~     we want to see how the timing of when 5AC and entinostat are given affects the magnitude of~     the disease response.~   "
133658|NCT01305486|"~     This will be an observational study designed to collect early, short- and long-term clinical~     outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will~     be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.~   "
133659|NCT01305473|"~     This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing~     Sepramesh at least 12 months before starting in this study.~      The consented subjects' medical records will be reviewed for evidence of any risk factors of~     hernia recurrence, procedure time, complications and any documented recurrences. The~     subjects will be asked to undergo a physical exam to rule out any recurrences that were not~     documented in the medical records.~   "
133660|NCT01305460|"~     A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine~     (Vidaza®) in intermediate-2 and high risk MDS patients.~   "
133661|NCT01305447|"~     Adult female smokers will participate in an exercise-aided smoking cessation program, and~     will then be randomized into one of four cessation maintenance conditions: (a) Exercise~     Maintenance only (b) Exercise Maintenance + Relapse Prevention Booklets(c) Relapse~     Prevention Booklets + Contact and (d) Contact Control. Primary follow-up outcome is smoking~     behaviour. Secondary outcomes include exercise behaviour, Physiological measures (body~     composition (Dual-emission X-ray absorptiometry; DXA), vascular health (stiffness,~     endothelial function, carotid plaque volume), physical fitness), and Psychological measures~     (self-regulatory cognitions related to exercise adherence [exercise, scheduling, barrier,~     relapse, and concurrent self-regulatory self-efficacy]).~      The hypotheses detailed below are specific to the randomization of participants into the~     following 4 groups:~        1. Exercise Maintenance only~        2. Exercise Maintenance + Relapse Prevention Booklets~        3. Relapse Prevention Booklets + Contact~        4. Contact Control~      Hypothesis 1: Compared to quitters in the contact control condition, quitters exposed to a~     home-based lifestyle exercise maintenance intervention (Exercise Maintenance only and~     Exercise Maintenance + Relapse Prevention Booklets) will demonstrate significantly greater~     exercise adherence and fitness levels, as well as significantly less weight gain and smoking~     relapse rates following exercise-aided smoking cessation program termination.~      Hypothesis 2: Compared to quitters in the contact control condition, quitters exposed to~     relapse information only (Relapse Prevention Booklets + Contact) will experience~     significantly less smoking relapse following exercise-aided smoking cessation program~     termination.~      Due to the novelty and exploratory nature of the respective prevention programs, no~     hypotheses are specified with respect to which prevention program (exercise maintenance or~     relapse prevention information) will be superior to the other, or whether the additive~     benefits (i.e., exercise maintenance plus relapse prevention information) will be superior~     to one prevention program alone.~   "
133662|NCT01305434|"~     Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries.~     Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose~     of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by~     measuring blood glucose two hours after eating a meal and taking a capsule containing either~     mulberry leaf extract or a placebo.~   "
133665|NCT01305395|"~     1. Early initiation of sirolimus will prevent or delay the development of intimal~          thickening and subsequent graft failure.~        2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on~          intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV~          compared to treatment guided by angiography.~        3. Prevention of the development and progression of intimal thickness on IVUS will prevent~          the development of heart failure, graft dysfunction, and cardiovascular death related~          to CAV.~        4. Small artery elasticity predicts progression of cardiac allograft vasculopathy and is~          modified by sirolimus~        5. Patients who have no progression of CAV will have favorable improvement in biomarkers~          and endothelial cells compared to patients who have progression of CAV~   "
133666|NCT01305382|"~     Abnormal peripheral endothelial function and alterations in circulating biomarkers that are~     associated with endothelial activation and inflammation correlate with angiographic evidence~     of cardiac allograft vasculopathy, defined as greater than 25% stenosis in a major coronary~     artery.~   "
133667|NCT01305369|"~     Cysteinyl leukotrienes (cys-LTs) are lipid inflammatory mediators that abound in mucosal~     inflammation and play a validated role in the pathogenesis of human asthma. It has recently~     been demonstrated that the platelet adenosine diphosphate (ADP) receptor, P2Y12, is required~     for LT4-mediated pulmonary inflammation and could be a novel potential therapeutic target~     for asthma. Thienopyridines (such as ticlopidine and clopidogrel) are pro-drugs, with proven~     antithrombotic efficacy, whose active metabolites selectively inhibit the platelet P2Y12~     receptors. One of the drawbacks of thienopyridines is the high inter-individual variability~     in pharmacological response, mostly due to the high inter-individual variability in the~     capacity of transforming the pro-drug in its active metabolite. Prasugrel is a new member of~     the class of thienopyridines, with faster onset of action and a more uniform inhibition of~     platelet function compared to the other thienopyridines. Primary objective of our study will~     be to test whether or not the inhibition of the platelet P2Y12 receptor by prasugrel reduces~     the bronchial hyper-reactivity in patients with chronic asthma. The investigators designed a~     randomized, double blind (Subject, Caregiver, Investigator, Outcomes Assessor), crossover,~     placebo-controlled, prospective study, which will enroll 26 patients. Randomization will be~     performed in sequential blocks. Patients will be blindly and randomly allocated to treatment~     A (prasugrel 10 mg daily) or B (placebo) for 15 days. After a 15-day wash-out period,~     patients who had initially been allocated to treatment A will be allocated to treatment~     B, and vice versa. Measurements will be done at baseline and on day 15 after each~     treatment, at the same time (+/- 1 h) of the day. Primary efficacy measure will be changes~     in airway hyper-responsiveness, recorded as reduction of FEV1 using the mannitol test~     induction. Secondary efficacy measures will be changes in markers of airway inflammation in~     sputum, changes in measurement of nitric oxide expiration (as surrogate marker of airway~     lung inflammation), count of eosinophil granulocytes in peripheral blood smear, changes in~     asthma exacerbation rates and symptom scores. Changes in phosphorylation of platelet VASP~     (Vasodilator-stimulated phosphoprotein) by ADP, measured with a flow cytometric technique,~     will be used as markers of the degree of inhibition of platelet P2Y12 receptors attained in~     each subjects by treatment with prasugrel.~   "
133668|NCT01305356|"~     STUDY OBJECTIVES:~      To demonstrate equivalent clinical and radiologic outcomes as gold standard (Autologous~     Bone Graft) in a representative clinical model (hindfoot fusions)~      STUDY HYPOTHESIS:~      Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in~     applications as shown by superiority analysis for safety and non-inferiority analysis for~     effectiveness~      STUDY RATIONALE:~      To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or~     injuries requiring bone graft in a representative clinical fusion model and thus the~     opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating~     an additional invasive procedure to harvest the graft~   "
133669|NCT01305343|"~     240 subjects with high risk adult spinal deformity requiring surgical correction will be~     enrolled in a prospective multi-center international study. High risk patients are defined~     by either their diagnoses and/or the type of surgical intervention as listed in the~     inclusion criteria. Neurologic complications in the form of new motor and sensory deficits~     will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2~     weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits~     will be adjudicated for relationship to the surgical intervention.~      Regression analyses will be used to evaluate the association between patient demographics,~     co morbidities, treatment history, spinal deformity characteristics, surgical~     characteristics, non-neurologic complications and pre-surgical status to occurrence of a~     neurologic deficit after surgery.~   "
133670|NCT01305330|"~     There is a rising incidence of incidentally detected small renal tumours due to improved~     imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo~     surgery and therefore there is limited data about the natural history of these tumours.~     Several small series have reported that most of these small masses grow slowly and might not~     require early intervention and that only some masses grow rapidly requiring immediate~     surgery. Presently, the investigators have not been able to identify prospectively which~     masses are going to grow slowly. The investigators plan to use computed tomography (CT) and~     Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to~     determine which masses will behave more aggressively. Additionally, the observations on the~     natural history of small renal masses need to be validated with a multicentric and~     systematically followed cohort.~   "
133671|NCT01305317|"~     This is double blind randomized controlled trial on the statins effects on serum IgG, IgA~     and IgM level in chronic hemodialysis patients in Bandarabbas~   "
133672|NCT01305304|"~     Until now it has been assumed that regular endurance training has a positive influence on~     cardiac function and that the positive effect increases with increasing intensity. However,~     little is known about the effects of intense endurance stress on the heart. According to~     current knowledge repeated exposure to strenuous endurance activity may lead to minor but~     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.~      Within this study the investigators attempt to find out by different analytical methods - in~     particular magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the~     heart muscle is affected by long term intense endurance exercise and which changes in~     cardiac function and morphology can possibly be found. Therefore the investigators compare~     former national competitive endurance athletes with sedentary controls.~   "
133673|NCT01305291|"~     Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as~     Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or~     increasing satiety signals from the gut. This research aims to determine whether or not~     Fibersol-2 may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing~     satiety signals from the gut.~   "
133690|NCT01305070|"~     Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses~     or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard~     balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral,~     Invatec).~   "
133674|NCT01305278|"~     Patients with a unilateral vestibular loss often complain of dizziness and imbalance.~     Movement usually increases these symptoms often resulting in patients avoiding these~     movements, causing further limitations in their activities of daily living. Vestibular~     Rehabilitation (VR) involves a series of adaptation and balance exercises to improve~     symptoms of postural stability. There is evidence that stroke patients gain benefit in their~     rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar~     advantages can be shown for balance patients. We plan a 3 arm study. As there is a~     considerable wait list for VR, the first arm will receive a Wii console and instructions to~     use it on the wait list and during VR. The second arm will receive a Wii console and~     instructions at the end of the waiting list and will use it during VR only and the control~     group will receive no Wii. All will spend the same time on the wait list and will receive~     identical assessments and VR~   "
133675|NCT01305265|"~     The purpose of this study is to test whether the incidence of sore throat and other tracheal~     co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer~     at the beginning of surgery to inflate to the proper pressure compared to the standard~     technique.~      The investigators hypothesis is that inflation of the endotracheal balloon using a cuff~     manometer immediately after intubation will reduce the incidence of sore throat and other~     tracheal co-morbidities.~   "
133676|NCT01305252|"~     The Study Hypothesis:~      Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a~     traditional step-up approach.~      The study will evaluate:~        1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by~          cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at~          outcome at 48 weeks.~        2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and~          cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials~          in PAH.~        3. Utility of longer clinical trial design with the use of combined clinical events as~          time to clinical worsening surrogate~   "
133677|NCT01305239|"~     Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which~     it is used in clinical practice in France (as adjuvant endocrine therapy).~   "
133678|NCT01305226|"~     This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some~     strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two~     natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for~     investigational use in preliminary trials. Like SK, it forms an equimolar complex with~     plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated~     molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate~     active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu.~     This fibrin-selectivity is due in large measure to potent activation at the clot surface by~     trace amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin.~     Hence, it provides an interesting and promising alternative therapy.~   "
133679|NCT01305213|"~     This randomized phase II trial studies how well bevacizumab with or without fosbretabulin~     tromethamine works in treating patients with ovarian epithelial, fallopian tube, or~     peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as~     bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine~     may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet~     known whether bevacizumab is more effective with or without fosbretabulin tromethamine in~     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.~   "
133680|NCT01305200|"~     This randomized phase III trial is studying how well Caphosol rinse works in preventing~     mucositis in young patients undergoing autologous or donor stem cell transplant.~     Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth~     sores, in patients undergoing stem cell transplant.~   "
133681|NCT01305187|"~     This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3~     in the treatment of nasolabial folds~   "
133682|NCT01305174|"~     The objective of this prospective, randomized,controlled and multicenter trial is, to~     compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the~     selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of~     common and external iliac artery disease.~   "
133683|NCT01305161|"~     To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to~     neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which~     may be used for an ulterior anaesthesia in case of allergy to one given NMB.~   "
133684|NCT01305148|"~     The WARFARIN Study is a clinical trial designed to determine if the use of genetic~     information related to warfarin sensitivity can help create a dose of warfarin that will~     result in less hospitalizations and deaths related to warfarin.~   "
133685|NCT01305135|"~     Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the~     FDA/EMEA approved Schedule and dosing.~      For the Phase I study :~      Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine~     in patients with INT-2 or higher risk MDS.~      For the phase II study:~      Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000~     criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher~     risk MDS~   "
133686|NCT01305122|"~     This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II~     glioma will be followed during 5 years.~        -  cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)~        -  cohort B: patients with disease simple monitoring.~      The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive~     functions and quality of life, using validate and standard tests.~   "
133687|NCT01305109|"~     The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary~     objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe~     rotavirus gastroenteritis, in comparison with a placebo in India.~   "
133688|NCT01305096|"~     The purpose of this study is to determine whether inversions (specific yoga postures in~     which the heart is higher than the head) and other dynamic and static yoga postures affect~     heart rate variability, oxygen uptake, blood pressure, blood parameters and other objective~     measures of health, and a variety of subjective and objective measures of health in female~     and male individuals in Sweden.~   "
133691|NCT01305057|"~     The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates~     filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined.~     Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated~     with P-IP formulation on one side of the face and with a placebo formulation on the other~     side twice daily (morning and evening) for 28 days. All subjects gave written informed~     consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were~     evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S.~     ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.~   "
133692|NCT01305044|"~     Persons over age 65 years constitute a large and growing population of cancer survivors.~     Available data indicate that both short- and long-term female breast cancer survivors report~     more limitations related to strength and mobility than women with cancers of other sites and~     women without a personal history of cancer. Further, better mental health among breast~     cancer survivors has been shown to protect against physical decline and overall quality of~     life. The combination of mental and physical interventions may result in substantial~     improvements in quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one~     such intervention. TCC may be particularly suited toward elderly breast cancer survivors~     with impaired physical and/or mental functioning, yet despite its increasing popularity and~     benefits in healthy and diseased populations, its benefits have never been scientifically~     evaluated in this population. The overarching goal of this study is to conduct preparatory~     work regarding the effects of TCC on quality of life and physical function that will~     underpin future definitive trials of TCC in elderly cancer survivors. As part of this~     12-week trial, participants will be randomized to a TCC or a health education control group~     (HEC). Establishment of meaningful interventions that facilitate a more positive cancer~     survival experience in old age is an important issue; there are substantial public health~     and clinical benefits should a TC intervention be successful in this patient population.~   "
133693|NCT01305031|"~     In this randomized control trial, the investigators hypothesize that late-preterm infants~     resuscitated with a low oxygen delivery strategy (initiation of resuscitation with room~     air) will result in a significant reduction in oxidant stress without any harmful clinical~     effects.~   "
133694|NCT01305018|"~     This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation~     on resistance exercise-induced muscle damage and inflammation.~   "
133695|NCT01305005|"~     -  To investigate ocular haemodynamics after phacoemulsification surgery~        -  To evaluate the influence in people with different autoregulation of ocular blood flow~   "
133696|NCT01304992|"~     The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus~     angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the~     metabolism of proteins, lipids and cholesterol will be evaluated.~   "
133697|NCT01304979|"~     Acupuncture has been studied in the perioperative setting and shown to reduce pain, anxiety,~     nausea and vomiting. Studies have been conducted in orthopedic surgery patients, but not~     spine patients. The investigators study will look at a combination of acupuncture therapies~     for patients having low back spine fusions to assess pain levels and return to function.~      114 subjects will be randomized into a direct acupuncture therapy group (38), an indirect~     acupuncture therapy group (38), or usual care alone (38). All subjects will receive usual~     care for spine fusion patients.~      Direct acupuncture therapy subjects will have pre-op auricular seeds in four distinct ear~     points bilaterally, an acupuncture treatment on the day after surgery and an acupuncture~     treatment with gua sha on the 2nd day after surgery (typically day of discharge).~      The indirect acupuncture therapy group will have treatment timed exactly as the direct~     intervention group but consist of 'indirect' treatment: tape placed at ear points at pre-op,~     ear seeds placed on several body points on the first and second day after surgery.~      BPI, VAS, SPF36-2, and ODI measures will be taken at enrollment and at the 4-6 week~     follow-up appointment with subjects' spine surgeon. BPI and VAS will also be taken at day 3~     and day 7-10 additionally.~   "
133698|NCT01304966|"~     The purpose of the present study was to identify risk factors for more severe juvenile~     Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric~     population in Thailand by the employing a protocol that includes staging of disease severity~     using above mentioned staging system at the time of each endoscopic debridement, as well as~     human papilloma virus (HPV) genotyping.~   "
133699|NCT01304953|"~     The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several~     animal models. However, studies in human volunteers have not been reported except for one~     recent study suggesting that ondansetron could alleviate propofol-induced nociception.~     Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain~     than those anaesthetized with propofol. And we further posit that the difference is due to~     the nociceptive processing induced by the action of 5-HT3A receptors.~      In this prospective, randomized, double-blind, placebo-controlled study, we assessed the~     analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological~     laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.~   "
133700|NCT01304940|"~     The purpose of this study is to examine the relationship between trauma and startle. The~     investigators are also looking at the effect of menstrual phase on this relationship.~   "
133712|NCT01304784|"~     This study is an open-label, dose-escalation study of MM-111 with five different combination~     treatments with the main goal of determining the safety of MM-111 with each combination.~   "
133713|NCT01304771|"~     Probiotics are viable commensal microorganisms that promote the establishment of beneficial~     microflora. Animal and human studies demonstrate that probiotics can enhance body's immune~     response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a~     novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium~     (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast~     (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide~     [FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human~     volunteers, over 65 years of age, is designed to study the safety of this probiotic when~     patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then~     our aim is to do a larger study to see if we can improve influenza vaccine immune response~     while taking the probiotic compared to placebo.~   "
133701|NCT01304927|"~     Today, it is evident that vitamin D (VD) has more widespread effects than the classical~     actions related to bone mineralization and calcium homeostasis1. VD deficiency results in~     impaired reproductive performance in various species of animals, and recently the~     investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1)~     and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal~     vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases~     intracellular calcium in mature spermatozoa, and hence may be important not only for~     spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional~     study of 300 young healthy Danish men showed that men with lower levels of serum VD have~     significantly lower number of normally developed and motile spermatozoa. Hitherto, most~     cases of male infertility have been classified as idiopathic, and infertile couples have~     been referred to symptomatic treatment at infertility clinics. These fertility treatments~     are often physically demanding for the female partner as well as expensive for the health~     care system. Any treatment that might improve semen quality of involuntary infertile men~     would be beneficial both for the infertile couples and the society in general. Our findings~     that VD may play a role for human semen quality have not yet been tested clinically.~     However, if VD supplementation proves efficient this opens for the first time for a causal,~     safe and cheap treatment of at least some cases of idiopathic impaired semen quality. The~     investigators believe our new human data supported by the results from the VD deficient and~     VDR KO animal studies and the high proportion of VD deficient Danish men provide sufficient~     evidence to initiate a randomized clinical trial of VD supplementation to infertile men.~     Infertile men have also have unfavorable altered levels of sex hormones and higher mortality~     than fertile men. Since VD deficiency is associated with increased mortality, regulation of~     aromatase, immune system, bone metabolism, glucose metabolism, cardiovascular system etc.~     our suggested clinical trial may also be able to evaluate several secondary endpoints in~     addition to the potential effect on semen quality.~   "
133702|NCT01304914|"~     In this study, the investigator will be approaching pregnant women to undertake 2 years of~     weekly respiratory and nappy specimen collection from their healthy new born infant. These~     specimens will be mailed to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory~     where they will be stored and batched tested for viruses and bacteria. As well as this,~     parents will keep a simple daily symptom diary for their child, allowing us to match~     detection of viruses and bacteria to periods when the study child did or did not have~     symptoms. This will help our understanding of what finding these viruses and bacteria in~     specimens from children really means.~   "
133703|NCT01304901|"~     The purpose of this study is to determine if adding single dose of oral montelukast to the~     standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for~     treatment of acute wheezing provide additional clinical benefit in the emergency room.~   "
133704|NCT01304888|"~     The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in~     Mexico that do not receive benefits from other federal food aid programs, have less than~     2,500 inhabitants and a high level of marginalization. Marginalization is a term used in~     Mexico for the multidimensional assessment of poverty in a community.~      When the program started in 2003 it provided beneficiary households either a cash transfer~     of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly~     food basket with a cost to the program of 150 pesos. The size of the cash transfer and the~     amount of food was the same for all households, i.e. no adjustments for family size or~     composition were made. The basket contained a number of staple and basic food products and~     powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table~     1). The composition of the food basket conformed to the Mexican norm for food aid programs~     (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the~     recommended daily energy and protein requirements. Beneficiary households were required to~     attend nutrition and health education sessions and had to participate in program related~     logistic activities in order to receive the benefits. These program conditionalities,~     however, were not strictly enforced.~      A community randomized controlled intervention trial was used to evaluate the impact of the~     intervention. A random sample of 208 rural communities was drawn from the pool of eligible~     communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas,~     Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each~     community a random sample of 33 households was selected. The baseline survey was conducted~     from October 2003 to April 2004. After baseline data collection, the 208 selected~     communities (6,687 households) randomly assigned to one of four study groups: food basket~     without education (52 communities, 1657 households), food basket with education (52~     communities, 1680 households), cash transfer with education (53 communities, 1687~     communities) or control (51 communities, 1663 households). Treatment allocation was carried~     out by the Ministry of Social Development.~   "
133705|NCT01304875|"~     When to start children with Fabry disease on therapy is controversial because of its expense~     and inconvenience. Many Fabry children complain of exercise intolerance. In adults, the~     investigators have found decreased lung function and ability to exercise on a treadmill.~     Whether or not lung function and exercise capacity is abnormal in children is unknown. While~     lung function and exercise tests are commonly part of routine evaluations for adults with~     Fabry, they are not yet for children.~      The objective of the proposed study is to more accurately define the lung and exercise~     abnormalities in a group of 20 boys from 8-18 years of age with Fabry disease who have not~     been treated with enzyme replacement therapy (Fabrazyme).~   "
133706|NCT01304862|"~     The purpose of this study is to determine whether mental health treatment disengagement may~     be mitigated by reducing barriers to self-management and enhancing self-management skills.~   "
133707|NCT01304849|"~     The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD~     chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor~     outcome (<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve~     higher cure rates have more side effects. Hence the investigators propose to use Interim PET~     CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is~     known that those with interim PET positive disease have a cure rate of less than 10-15% if~     continued with ABVD alone) and to use EB selectively in this population in an attempt to~     improve treatment outcomes - at the same time to limit side effects of therapy.~      Thus, this study is an attempt to improve the outcome in the small subset of poor responders~     to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy~   "
133708|NCT01304836|"~     The purpose of this study is to focus on potential differences in the occurrence of~     new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of~     immunosuppressive treatment are compared.~   "
133709|NCT01304823|"~     The purpose of this study is to determine the functional significance of sweet taste~     receptors in the secretion of GI satiation peptides by using a specific sweet taste receptor~     antagonist to block sweet taste perception in the gastrointestinal tract.~   "
133710|NCT01304810|"~     The purpose of the study is to obtain two year follow up data for subjects that received six~     vaccinations of NicVAX in prior phase III studies. No treatment will be administered.~     Anti-nicotine antibody levels and safety data will be collected.~   "
133711|NCT01304797|"~     This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a 3+3~     design. Successive cohorts of three or more patients will be treated at escalating doses~     until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified,~     an Expansion Cohort will be enrolled at that dose to further characterize safety and~     pharmacologic endpoints. Additional arms will be enrolled to explore the combination of~     MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2~     positive breast cancer.~   "
133714|NCT01304758|"~     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided~     focused ultrasound thermal ablation of a designated area in the brain of patients suffering~     from medication-refractory Essential Tremor, using the ExAblate transcranial system.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion~     created in the ventralis intermedius nucleus of the thalamus.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in~     progress, and confirm that the ablation is proceeding according to plan, thus closing the~     therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      The ExAblate transcranial system is an experimental device and is being investigated in this~     study.~   "
133715|NCT01304745|"~     The purpose of the study is to evaluate and compare the effect of: 1 Educational and~     counselling in groups, 2) Physical training in group with 3) Control group, on global- and~     health related quality of life and coping in patients finished treatment for gynaecological~     cancer.~   "
133716|NCT01304056|"~     Respiratory muscles seem to be activating differently in critically ill patients than in~     healthy persons. Needle electrodes would provide artefact-free signal information about~     muscle activation. However, needle recordings are an invasive technique which limits its~     feasibility in clinical setting. Intention of this study is to investigate if surface~     electromyography could be used to measure recruitment patterns of ventilatory muscles.~   "
133717|NCT01304043|"~     To take charge of the treatment in rare adult ovarian tumors with an homogenous manner~     (germinal and sexual cords tumors), at different stages of the disease.~   "
133718|NCT01304030|"~     Our research hypothesis is that residents who participate in the empathy and relational~     skills training modules will significantly improve in these skills as compared to a control~     group of residents who receive residency training as usual that includes the current~     standard training in the doctor-patient relationship. To evaluate this hypothesis, we will~     use a two-pronged approach to assessment. The first prong is the residents' self assessment~     of empathy and the second is from the patients' perspective.~   "
133719|NCT01304017|"~     In Israel approximately 16,000 people have a stroke each year. Most of these people suffer~     from weakness or paralysis of half of their body which leads to difficulties performing~     basic activities of daily life (BADL) such as dressing and walking. Due to the stroke, these~     individuals need to undergo intensive rehabilitation. After rehabilitation, physical~     activity has been strongly recommended to maintain their functional level which was achieved~     during rehabilitation. In addition regular physical activity can prevent secondary condition~     However, recent findings suggest that people with stroke do not perform enough physical~     activity with their upper and lower extremities.~      The use of Virtual Reality (VR) for rehabilitation has been found to have potential for~     encouraging active purposeful movement. Many researchers have assessed the feasibility &~     usability of different VR systems and environments for individuals with stroke. Costly VR~     systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy,~     Nintendo Wii) have been found to have great potential to encourage active purposeful~     movement. However, to date, only a limited number of studies have investigated the~     effectiveness of VR therapy post-stroke.~      Since physical activity is important after stroke and the fact that individuals with stroke~     are not participating sufficiently in physical activity, I suggest to carry out this study.~      The overall aim of this study is to assess the effectiveness of using novel technology of VR~     therapy to promote the participation in daily physical activity of individuals with stroke.~     A 'Community based' VR program will be compared to a traditional therapy program in~     promoting daily physical activity of the lower and upper extremities.~      It is hypothesized that the VR intervention will be more efficient than the traditional~     therapy in promoting physical activity (walking and use of the weak upper extremity).~   "
133720|NCT01304004|"~     Worldwide, obesity rate has increased so much in the latest years, that we call it obesity~     epidemic. Overweight could result of an unbalanced energetic balance for years. The person~     who regularly consumes more calories than she expends will find herself with a positive~     energetic balance, which results in a weight gain. A daily overconsumption of only 10~     calories comes with a weight gain throughout one year. A way to avoid this overconsumption~     is to eat food that increases satiety. Satiety can be defined as the time interval after~     food ingestion, during which hunger and desire to eat are suppressed.~      The general objective of the study is to investigate in a pilot study the impact of a~     drinkable yogurt enriched in proteins and fibres on satiety.~   "
133721|NCT01303991|"~     The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate~     based photodynamic therapy in patients with intermediate or high-risk transitional cell~     carcinoma of the bladder.~   "
133722|NCT01304732|"~     This is a retrospective analysis of infection on catheters of pediatric oncology patients.~   "
133723|NCT01304719|"~     The current protocol aims to examine the effects of a computer-based intervention used in~     conjunction with existing Healthy Families America (HFA) home visitation programs on the~     challenges related to participant enrollment, retention, and motivation as well as parent~     and child outcomes.~   "
133724|NCT01304706|"~     This study will assess the safety and utility of the new inserter for the administration of~     ILUVIEN in subjects with diabetic macular edema.~   "
133725|NCT01304693|"~     The purpose of this study was to assess the safety, tolerability, and the effects of~     treatment on ocular outcomes following a single intravitreal administration of ESBA1008~     compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).~   "
133726|NCT01304680|"~     Retrospective study to evaluate the characteristics of patients and of fluid resuscitation~     during intensive care unit hospitalization of patients under septic chock.~   "
133727|NCT01304667|"~     This retrospective, multicenter study is designed to collect tumor characteristics as well~     as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of~     the vulva with emphasis on indication and application of radio- and chemotherapy.~     Application of chemotherapy in primary treatment of vulvar cancer is rare; the study~     collective is therefore extended to relapsed disease.~   "
133729|NCT01304641|"~     The purpose of this study is to compare rates and risk of primary cardiovascular events~     among elderly patients newly initiating therapy with atorvastatin or simvastatin. The~     specific objectives for this project are to: 1) examine the demographic and clinical~     characteristics of the elderly patients in whom atorvastatin or simvastatin was newly~     initiated; and 2) compare cardiovascular event rates in elderly patients in whom~     atorvastatin or simvastatin was newly initiated.~   "
133730|NCT01304628|"~     The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994,~     administered to patients with asthma can achieve a clinically meaningful increase in~     pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an~     acceptable safety profile. The study will characterize the bronchodilator effect, dose and~     safety of PL-3994 in a population of moderately severe, stable asthmatics following~     overnight withdrawal of beta-2 agonists.~   "
133731|NCT01304615|"~     Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted~     via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight~     by increasing physical activity, decreasing the energy density of the diet, and increasing~     consumption of low energy dense self-made meals by providing culinary training skills.~   "
133732|NCT01304602|"~     This phase I trial will use the combination of irinotecan and BKM120 in patients with~     advanced colorectal cancer who have failed on or have become intolerant of at least one line~     of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.~   "
133733|NCT01304589|"~     The primary aim of this study is to determine the efficacy of milnacipran in reducing pain~     in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to~     fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The~     investigators will also determine whether associated symptoms in PVD, including~     psychological distress, impairment of sexual function, physical function, and quality of~     life, are correlated with a reduction in vulvar pain.~   "
133734|NCT01304576|"~     The area of the brain responsible of visuospatial processing data and more specifically the~     orientation of an object or image is located in parietal lobe, especially on the right side.~     A dysfunction of this region would result in a disorder of recognition of the orientation of~     objects and images that the investigators call orientation agnosia. Several isolated cases~     are reported in the literature but to the investigators knowledge deficit has never been~     systematically searched, or put into perspective compared to other neuropsychological~     deficits. Moreover, the precise location of the lesion responsible for such a disorder~     remains uncertain. The objectives of this study are (1) detect the existence of orientation~     agnosia in case of right parietal lesion, and (2) to improve the understanding of such a~     deficit allowing better management of this disorder.~   "
133735|NCT01304563|"~     Intradermal influenza vaccination may result in better efficacy when compare to~     intramuscular vaccination.~   "
133736|NCT01304550|"~     This is a retrospective comparison of hemoglobin measurements obtained by arterial blood gas~     analysis and the Masimo Continuous Hemoglobin Monitor~   "
133737|NCT01304537|"~     Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II~     trial as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its~     anti-inflammatory properties. AAT is an acute stress reactant protein that increases during~     inflammation. In T1DM inflammation serves a major role in disease progression.~   "
133738|NCT01304524|"~     This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100~     DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18~     associated Cervical intraepithelial neoplasia grade 2/3 or 3.~   "
133739|NCT01304511|"~     The purpose of this post-marketing surveillance is to identify problems and questions~     regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of~     premature luteinizing hormone (LH) surges in women undergoing controlled ovarian~     hyperstimulation (COH) for assisted reproduction techniques (ART).~   "
133740|NCT01304498|"~     Primary objective:~      • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers~     (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.~      Secondary objectives:~        -  To evaluate the tolerability of V503 in 9-15 year-old girls.~        -  To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or~          GARDASIL.~   "
133741|NCT01304485|"~     Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer~     to select patients who may benefit from directed therapy~   "
133742|NCT01304472|"~     Clopidogrel administration is considered standard of care in patients with stable coronary~     artery disease post PCI. However , a significant proportion of patients is considered~     clopidogrel resistant and this is shown to be accompanied by future adverse events. The~     hypothesis of the study is to define among consecutive outpatient clinics individuals with~     stable coronary artery disease being on chronic clopidogrel treatment, those that are~     clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel~     resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or~     clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment~     crossover will be performed without a washout period. At Day 28 platelet reactivity will be~     assessed as well.~   "
133743|NCT01304459|"~     Observational protocol to analyse routine vancomycin serum levels of patients under~     intensive care and to obtain percentage of patients that achieve therapeutic values.~   "
133744|NCT01304446|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM.~      METHODS: Patients older than 1 year followed during anticancer therapy were included from~     January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0~     or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at~     these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR)~     was indicated.~   "
133745|NCT01304433|"~     The study is primarily aimed to collect further data on the safety of the investigational~     product in a large patient population when used in routine clinical practice in the~     Asian-Pacific region.~   "
133746|NCT01304420|"~     The purpose of this study is to analyse the usability of ultrasonography together with~     biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis.~     The investigators hypothesize that serum and urine markers of cartilage and bone synthesis~     and degradation, together with ultrasound measurements of joint cartilage thickness, are~     useful tools in the early evaluation of JIA patients, - as diagnostic, prognostic and~     monitoring methods.~   "
133747|NCT01304407|"~     Osteosarcoma is the most common malignant bone tumor in children and adolescents. Because~     cure rates for osteosarcoma have remained stagnant for the past several decades despite~     numerous trials of chemotherapy agents, novel therapies based on the understanding of the~     molecular pathogenesis of osteosarcoma are needed. Rothmund-Thomson Syndrome (RTS) is a~     genetic disorder affecting many parts of the body and resulting in major skeletal~     abnormalities. This disease also has the propensity to increase the risk of developing~     cancer, particularly osteosarcoma. Two-thirds of RTS patients have a high risk of developing~     osteosarcoma. Therefore, it is important to understand the impact of RTS on the skeletal~     phenotype (as measured by calcium absorption and bone mineralization) in order to develop~     effective therapies to battle osteosarcoma.~   "
133748|NCT01304394|"~     The primary objective of this study was to provide daily information on the performance~     safety of the Ped3CB in practical therapeutic use in pediatric patients.~   "
133749|NCT01304381|"~     Patients with severe heart failure have as many symptoms as many patients with cancer but~     yet do not have equal access to supportive and palliative care. They have an unpredictable~     course of illness, which makes difficult to judge when the palliative stage has been~     reached. The Heart failure and Palliative care Programme is a three-year project in Sweden~     financed by the Swedish Association of Local Authorities and Regions (SALAR). The overall~     aim is to develop, implement and evaluate a model that integrates cardiac care and~     palliative advanced home care for patients with severe chronic heart failure. The primary~     aim is to study the effects on patients' symptom burden, quality of life and activities of~     daily living. A randomized controlled clinical study is planned.~      Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the~     European Society of Cardiology and with NYHA III-IV symptoms and at least one of following~     criteria will be included;~        1. At least one episode of worsening heart failure that resolved with injection / infusion~          of diuretics or the addition of other heart failure treatment in the last 6 months and~          regarded optimally treated according to the responsible physician.~        2. Need for infusions-treatment.~        3. Chronic poor quality of life (VAS < 50)~        4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body~          weight within the last 6-12 months)~        5. less than one year life expectancy The participants will be randomized to intervention~          or control group. The intervention consist of a multidisciplinary approach and~          collaboration between specialist palliative and heart failure (HF) caregivers, in a~          shared structured person-centred and identity-promoting care at home during six months.~          Usual care is performed for the control group.~   "
133750|NCT01304368|"~     Chronic neck pain is a common worldwide problem. In the majority of cases, patients are~     treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the~     therapeutic application of topical heat - provides an easy to apply self-help strategy in~     patients with chronic neck pain. However, despite the frequent use in clinical practice,~     there is no research regarding this topic yet.~      The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck~     pain induces changes in perceived pain intensity and in sensory processing.~   "
133751|NCT01304355|"~     Irritable bowel syndrome (IBS) is a common disorder affecting up to 20% of the general~     population. Despite the prevalence of the disorder, it remains poorly understood. This is~     reflected in a symptom based diagnostic scheme, the lack of a suitable biological marker and~     inadequate treatment options. Current knowledge suggests the disorder is as a result of a~     dysregulated brain-gut axis, a complex construct describing the bidirectional communication~     systems underpinning normal gastrointestinal functioning.~      The investigators hypothesize here that the disruption of this brain-gut axis is facilitated~     by an increased degradation of tryptophan along the kynurenine pathway. This metabolic~     abnormality has the potential to impact on both GI and CNS signaling through its effects on~     serotonergic signaling and the impact of metabolites like kynurenic acid and quinolinic acid~     on cognitive processes respectively.~      Previous data from our laboratory indicated increased tryptophan degradation in IBS patients~     and suggested the metabolites produced as putative biological markers of the condition. In~     this study the investigators aim to reconcile cognitive impairment in IBS with GI and CNS~     symptom severity and kynurenine pathway metabolites.~      The investigators will establish these baseline measures in IBS compared to control~     subjects. A battery of cognitive assessments will be carried out using a computerized~     testing system. Standardized rating scales will be used to assess GI and CNS symptom~     severity. GC-MS/MS, a recently acquired technology platform in our laboratory, will be used~     to quantify plasma quinolinic acid levels.~   "
133752|NCT01304342|"~     Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP~     will decrease the propofol requirements for predetermined sedation levels (as shown by~     Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored~     by Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less~     postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive~     impairment after sedation (as assessed by the MiniMental test).~   "
133753|NCT01304329|"~     The objective of the study is to investigate the drug-drug interaction potential between BI~     10773 and simvastatin.~   "
133754|NCT01304316|"~     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety~     of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline~   "
133755|NCT01304303|"~     Phase I study of SPARC1023 alone and in combination with carboplatin~   "
133756|NCT01304290|"~     Our objective in this study will be to determine if implementing the glucose/insulin clamp~     (GICT) on cadaveric organ donors can:~        -  Prevent hyperglycaemia~        -  Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours~          therapy with the GICT prior to organ procurement.~        -  Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant~        -  Assess graft function by evaluating:~             -  Liver: post-transplant liver function score (PTLF)~             -  Kidney: graft function as defined by UNOS (immediate graft function IGF, slow~               graft function SGF and delayed graft function DGF and~             -  Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at~               day one and seven post-transplantation~   "
133757|NCT01304277|"~     This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.~   "
133760|NCT01304238|"~     The purpose of this retrospective registry is to collect data about patients with acute HIT~     II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid,~     Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily~     routine in this indication in Germany.~   "
133761|NCT01304225|"~     This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern~     SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative~     retinopathy will be treated with panretinal photocoagulation utilizing different treatment~     strategies. The investigators believe that using lower laser parameters, the clinical~     response may be equivalent with less adverse effects.~   "
133762|NCT01304212|"~     The purpose of this study is to compare the analgesic effectiveness of three techniques: the~     femoral nerve block, intraarticular infiltration or a combination of both in the control of~     pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the~     performance multimodal postoperative pain KA combining two analgesic techniques to obtain~     better analgesia than when applied separately.~   "
133763|NCT01304199|"~     The purpose of this study is to assess the various aspects of life in the cancer survivors~     in India. Cancer survivor is defined as an individual diagnosed with cancer and who has~     survived the disease and treatment, and for the rest of his/her life.~      Cancer survivors are at increased risk of developing various physical and psychosocial~     conditions, which require to be identified and attended within the cancer care system.~      Survivorship research is seen as addressing the medical, functional, and health related~     issues of individuals diagnosed with cancer, as well as that of their families.~   "
133764|NCT01304186|"~     The purpose of this study is to evaluate the acceptability and efficacy of a computer-based~     tailored information application designed to promote health literacy in persons treated for~     HIV infection. The study hypothesis is that the application will be acceptable and usable~     for persons treated for HIV infection, and will improve their levels of adherence to~     antiretroviral medication treatment.~   "
133765|NCT01304173|"~     This is an observational study involving a retrospective review of medical records of adult~     patients who have been treated with intravesical valrubicin for bladder carcinoma in situ~     (CIS) since October 2009.~   "
133766|NCT01304160|"~     The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation~     therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients~     with locally advanced pancreatic cancer.~   "
133767|NCT01304147|"~     The objective of the current study is to investigate the safety and efficacy of a single~     dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).~   "
133768|NCT01304134|"~     To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in~     the pain relieving treatment during 48h postoperative period, by comparing with morphine~     i.v. PCA.~   "
133769|NCT01304121|"~     This is a randomized clinical trial that will be carried out to examine the use of bioactive~     glass granules (S53P4) as bone graft substitute in filling small and large bone defects as~     compared with autogenous and allogeneic bone grafting, respectively.~   "
133770|NCT01304108|"~     Preventing the formation of blood clots in the veins so they do not injure leg veins or~     travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential~     component of safe in-patient care, yet it is deployed sub-optimally in many hospitals,~     including The investigators own. Two prior VTE-P improvement projects were completed at Mayo~     Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of~     the Department of Surgery. Both projects resulted in marked improvement in the percentage of~     patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from~     these two pilots along with known best practices for &quot;spreading&quot; to deploy methods~     that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate~     VTE-P rates exceeding 95%.~   "
133771|NCT01304095|"~     The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill~     test) exercise duration in four ethnic subgroups with established coronary artery disease~     and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian~     and East Indian.~   "
133772|NCT01304082|"~     When one receives a local anesthetic, such as novocaine for a dental procedure, there is a~     burning painful sensation experienced upon injection of the local anesthetic. We are trying~     to understand the role of pH (how acidic a solution is) in the production of pain during~     local anesthetic administration. We hypothesize that less acidic solutions produce less~     burning. We also want to determine whether or not the pH of the solution affects the rate of~     onset of the local anesthesia. We will recruit subjects from patients who have a clinical~     indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at~     the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve~     blocks are administered at adjacent spinal levels, typically using either lidocaine or~     bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part~     of the research procedure and then provide lidocaine at the control location before~     continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to~     compare the effects of the three solutions. There will be almost no deviation from the~     standard clinical procedure. After the injection of each solution, the pain score on~     administration of the medication will be recorded immediately. We will also provide a~     continuous stimulation (pin taps) after the local anesthetic injection and record when the~     patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation).~     Finally, we will record the pain score upon reinsertion of a needle to mark the precise~     location (part of the clinical procedure) one minute after the local anesthetic injection.~     All data will be collected during the a single clinical visit.~      The study will conclude when 60 subjects have successfully been tested. Data will be~     reviewed annually.~   "
133773|NCT01304069|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral~     tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy~     male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15%~     of the ideal weight for height are taken into the study. Primary endpoints of the study are~     plasma concentrations of tramadol and its metabolites.~   "
133774|NCT01303978|"~     Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin~   "
133803|NCT01303601|"~     Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown~     efficacy in bipolar depressive episodes in retrospective studies. However, there has been no~     prospective study about the monotherapy of olanzapine. The investigators conducted a~     randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for~     treatment of the depressed phase of bipolar disorder.~   "
133775|NCT01303965|"~     One of the complications that can occur after a stem cell transplant is called graft versus~     host disease (GVHD). Another complication is that multiple myeloma may come back (relapse).~     In this study, a drug called lenalidomide will be started 1-2 months after a transplant, or~     possibly later depending on recovery of your side effects. Lenalidomide and sirolimus have~     been shown to work together against multiple myeloma. Therefore, lenalidomide will be~     combined with sirolimus with the hope that this will help prolong the amount of time the~     disease is in remission. Researchers hope these steps will help prolong the amount of time~     the multiple myeloma is in remission and will decrease the chance of GvHD.~   "
133776|NCT01303952|"~     Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent~     patients with untreated or refractory hemolytic cold agglutinin disease(CAD)~   "
133777|NCT01303939|"~     The purpose of the study is to determine if glaucoma is associated with neurodegenerative~     changes in areas of the brain other than the occipital lobe. This will help guide the~     direction of further research in the use of neuroprotective agents in preventing or~     controlling such changes. The final goal is to improve the quality of life for patients with~     glaucoma.~   "
133778|NCT01303926|"~     Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now~     considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main~     registrative trials are considered positive because they reached their objectives, but~     within them, the Quality of Life (QoL) of patients was not detailed neither has represented~     as primary objective of the studies. It is considered that, together with enhancements that~     are added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice~     if one of the associations show to be better tolerated by the patient and favours an~     amelioration of his QoL.~   "
133779|NCT01303913|"~     Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic~     Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to~     evaluate anthropometric and functional characteristics of COPD patients correlated with~     oxygen desaturation during Six-minute walking test (6MWT).~   "
133780|NCT01303900|"~     Life expectancy of hemophilia patients has improved considerably during the past decades and~     is approaching that of the general population. Hemophilia patients are therefore likely to~     be confronted with age-related disorders in addition to their primary illness and related~     diseases. Little is known about the occurrence of age-related co-morbidity, especially~     cardiovascular disease (CVD), in these patients. Low clotting factor levels are hypothesized~     to protect against both atherosclerosis and thrombus formation, resulting in a reduced risk~     of ischemic CVD. CVD mortality has been reported to be lower in haemophilia patients than in~     the general population, but data on non-fatal CVD are lacking, and no adjustment for CVD~     risk factors has been made so far.~      The aim of our study is to assess the occurrence of CVD and its risk factors in a large~     cohort of haemophilia patients.~      In this prospective multicenter cohort study in a group of 700-800 male patients with~     haemophilia A or B aged 30 years or older from The Netherlands and the UK, data on CVD~     history and CVD risk factors will be collected at baseline and compared with the general~     age-matched male population. Overall QRISK2 cardiovascular risk scores will be calculated~     and also compared with the general population. During a follow-up period of 5 and 10 years~     the occurrence of CVD events will be recorded and compared with the expected occurrence~     based on the QRISK2 scores and with data from the general population.~   "
133781|NCT01303887|"~     The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the~     treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).~   "
133782|NCT01303874|"~     TRIAL DESIGN~        1. Description This is a 18-month, double-blind, randomized, multicentre, outpatient~          study. The approximate duration of subject participation will be 18 months and the~          approximate total duration of the study will be 42 months. The duration of subject~          enrollment will be approximately 24 months.~        2. Discussion of Trial Design The study is designed to directly compare the effectiveness~          of combination therapy with MTX + ETN versus~        3. Principal research question/objective To determine the number of patients in clinical~          remission at 12 months of follow−up, as defined as the absence of symptoms and signs of~          inflammatory arthritis.~   "
133783|NCT01303861|"~     This study focuses on the first step in developing an algorithm for maximizing quit-smoking~     success based on an adaptive approach, which changes treatment from the initial nicotine~     replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT~     non-responders are switched (in double-blind fashion) before the quit date to receive~     either varenicline alone or varenicline paired with bupropion. Some participants who would~     otherwise have failed at their quit smoking attempt could be rescued by switching to~     alternative pharmacotherapies. The proposed study will evaluate the combination treatment~     against varenicline alone in an adaptive trial design~   "
133784|NCT01303848|"~     To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a~     circadian rhythm~   "
133785|NCT01303835|"~     To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in~     high grade glioma patients undergoing standard chemoradiation~   "
133786|NCT01303822|"~     Emotional and mental symptoms are common consequences of cancer diagnosis and treatment.~     Coping with these symptoms seems to be influenced by interpretation of illness, locus of~     health control and spiritual attitudes in dealing with illness.~      Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in~     cancer patients.~      The aim of this study is to investigate the effect of a mindfulness-based day-care clinic~     group program on quality of life, anxiety and depression in cancer patients and to evaluate~     the association with coping styles, spiritual attitudes in dealing with illness, mindfulness~     and interpretation of illness.~   "
133787|NCT01303809|"~     The investigators wish to standardise and optimise perioperative care for consecutive~     patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will~     compare patients under a standardised perioperative care program to patients who undergo~     routine perioperative in our hospital and determine whether patients who had optimised~     perioperative care went home earlier and had fewer complications.~   "
133804|NCT01303588|"~     The objective of this study is to evaluate whether yoga or qigong therapy is effective in~     treating low back pain in elderly patients compared to no therapy (waiting list control).~     The secondary aim is to compare yoga and qigong.~   "
133788|NCT01303796|"~     This Phase 3 study assesses two drug regimens as the initial treatment of patients who are~     at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the~     doctor does not recommend the use of standard intensive treatment or the patient has decided~     not to receive standard intensive treatment after being fully informed about its benefits~     and risks by his/her doctor. The two drug regimens are sapacitabine administered in~     alternating cycles with decitabine, or decitabine alone. The purpose of the study is to~     learn which drug regimen is more likely to keep AML in check as long as possible.~   "
133789|NCT01303783|"~     The purpose of this study is to determine the blood pressure lowering responses of various~     dose combinations of nifedipine GITS and candesartan as compared to treatment with each~     component on their own (monotherapy) and placebo (a look-alike tablet without active~     ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are~     currently approved for use in patients with essential hypertension alone or together with~     other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS~     and candesartan used together in the treatment of essential hypertension has not been~     established yet. In this study patients will be treated with various doses of nifedipine~     GITS and/or candesartan or placebo. These different regimens will be administered once a day~     and will be assessed based on their blood pressure lowering effects (mean sitting diastolic~     blood pressure) in subjects with mild to moderate essential hypertension.~   "
133790|NCT01303770|"~     Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million~     people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive~     impairment as a result of the disease including disturbances in memory, attention,~     concentration, information processing, and executive functions such as problem solving, and~     self-monitoring. MS-related cognitive impairments negatively affect many aspects of~     functioning and independent participation in everyday life. Thus, PwMS who experience~     cognitive impairments face a wide array of recurring barriers that pose grave challenges to~     carrying out everyday activities while trying to maintain multiple life roles and as they~     age.~      Management of cognitive symptoms can be addressed through rehabilitation which has the~     potential to reduce disability, prevent complications of the disease, and enhance~     participation, independence, and quality of life. Considering the high frequency of~     cognitive impairments in MS and their significant, complex impact on functioning and~     independence, it is critical that cognitive interventions be an essential component of MS~     rehabilitation.~      The overarching goal of this study is to develop and test a self-management, group-based~     cognitive rehabilitation program designed specifically for PwMS.~   "
133791|NCT01303757|"~     The primary aim of the study is to examine insulin secretion as an effect modifier of the~     efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese~     young adults in an 18-month, prospectively stratified, multi-center randomized controlled~     trial.~   "
133792|NCT01303744|"~     To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered~     once per day for up to 12 weeks to patients with mild cognitive impairment.~   "
133793|NCT01303731|"~     The objectives of this study is to test a combination of low dose local anesthetic~     Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal~     anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would~     result in effective spinal anesthesia with relatively limited motor block, quick recovery of~     motor function and relatively long lasting analgesia. We expect lower incidence of side~     effects with this combination than with convenient dose of Bupivacaine.~   "
133794|NCT01303718|"~     The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of~     vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart~     Failure.~   "
133795|NCT01303705|"~     This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of~     memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to~     induce tumor antigen release with the overall goal of promoting an immune response against~     prostate cancer.~   "
133796|NCT01303692|"~     Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist~     and -plus anti-androgen agent~   "
133797|NCT01303679|"~     In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity,~     is currently the standard treatment. In patients expressing hormone receptors, it was shown~     that hormone therapy administered in maintenance after induction chemotherapy, could have a~     benefit regarding the progression-free survival. The investigators make the hypothesis that~     there would be interest to discontinue treatment with taxane after 4 months, and to begin~     hormone therapy while continuing maintenance bevacizumab.~      Exemestane was chosen because it has been shown potentially active in patients who~     progressed after letrozole, anastrozole or tamoxifen.~   "
133798|NCT01303666|"~     Previous studies have indicated that patient expectations, beliefs and preferences may have~     an impact on treatment outcomes. The KIVIS study was primarily designed to compare two~     effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee)~     or intra-articular corticosteroid injection). At study entry any preference expressed by the~     patient for each of the treatment interventions was recorded. This study assessed the~     effects of two treatments given at a single time-point and hence the effects of patient~     preference could be assessed independently of any compliance issues.~   "
133799|NCT01303653|"~     Gastrointestinal leaks or perforations are currently treated through either open or~     laparoscopic surgical procedures. The purpose of this research is to determine whether new~     endoscopic tools are safe and effective in the treatment of such conditions and can overcome~     the need of invasive surgical procedures.~   "
133800|NCT01303640|"~     The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent~     is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion~     revascularization at 1-year and death or myocardial infarction at 3-year after stent~     implantation in the real world clinical practice.~   "
133801|NCT01303627|"~     The effect of maintenance remifentanil infusion with target controlled infusion during~     laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be~     investigated.~   "
133802|NCT01303614|"~     The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain~     during hysterosalpingography diagnostic practice.~   "
133805|NCT01303575|"~     This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation~     of the It's Your Game…Keep It Real (IYG) intervention, relative to a comparison condition on~     sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14~     years old). The original IYG program was designed for students in Houston middle schools to~     help students delay sexual initiation and if sexually active, use condoms and contraception.~     The present study will adapt the existing IYG program for an AI/AN youth cohort; the~     original IYG curriculum will be transferred into a web-based format and modified to~     incorporate additional culturally-relevant components. The primary hypothesis to be tested~     is: (1) students who receive the web-based curriculum will delay sexual activity relative to~     those who receive standard care. The major dependent variable is the proportion of students~     initiating sexual activity. Secondary hypotheses will examine the effect of the web-based~     curriculum on specific types of sex and psychosocial variables related to sexual risk-taking~     behavior. This project will also examine the effect of the intervention on the proportion of~     students who are sexually active, number of times students engage in unprotected sexual~     intercourse, and students' number of sexual partners.~   "
133806|NCT01303562|"~     The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h)~     bioavailability and pharmacokinetics of the major phytochemicals found whole barley and~     oats, as well as their effects on selected measures of antioxidation, inflammation, insulin~     sensitivity/glucose regulation, and vascular remodeling following challenge by an oral~     glucose tolerance test (OGTT).~   "
133807|NCT01303549|"~     The study is a randomized, open-label safety study comparing the use of anidulafungin (200~     mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B~     (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.~   "
133808|NCT01303536|"~     The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve~     and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms~     among obsessive compulsive disorder resistant patients.~   "
133809|NCT01303523|"~     The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin~     complications in patients with a lower limb trauma supported by physicians of mountain.~   "
133810|NCT01303510|"~     A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine~     Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines~   "
133811|NCT01303497|"~     Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma~   "
133812|NCT01303484|"~     The purpose of this study is to determine the effects of prebiotic B-GOS on the immune~     function, metabolism and gut microbiota of elderly people~   "
133813|NCT01303471|"~     During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid~     treatment is used for pain assessment.~      The change in haemodynamic variables and clinical sign are evaluated during anesthesia for~     pain assessment but these changes are not specific every time.~      The main of this study is to investigate the relationship between calculated compartment~     concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability)~     and APV (Arterial Pressure Variability) before a standard noxious stimulation during general~     anesthesia at calibrated hypnosis level.~      Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and~     that these effects would be blunted or abolished by by adequate analgesia. The current study~     is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during~     nociceptive surgical stimulation, at different levels of analgesia.~   "
133814|NCT01303458|"~     This research project is aimed to address low-income families' basic social needs (housing,~     food, employment, education, childcare, utilities) within the context of pediatric primary~     care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive~     impact of a similar intervention on pediatric residents' screening and referral to community~     agencies. This study will specifically test whether a further strengthened~     intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal~     enrollment in community resources and receipt of eligible benefits. In addition, we will~     measure the intervention's impact on maternal well-being, and compliance with well-child~     care (WCC) visits.~      The project will take place at eight community health centers in the Greater Boston Area.~     The centers will be randomized to either an intervention or control site. Mothers who bring~     their infant in for a WCC visit from birth to 6 months will be eligible. They will be~     followed until their child is one year of age. Study subjects will complete two~     self-administered surveys (baseline, follow-up), and one brief telephone interview (when~     their infant is 9 months old). Pediatric providers will also be subjects; and will fill out~     a demographic questionnaire at the time of enrollment.~      The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill~     out in the waiting room prior to their child's WCC visits; 2) Family Resource book~     containing 1-page information sheets on resources, that providers will have access to in~     exam rooms; 3) a Community Resource Coordinator who will assist families link to available~     resources, and update providers; 4) Training Session which will provide a 1 hr overview of~     the intervention to providers.~      Families attending the control health centers will receive standard of care. Enrolled~     mothers will be offered the intervention at the end of the 12-month follow-up interview.~     When follow-up data collection is complete, the PI will offer the control sites the~     opportunity to implement the BNS protocol.~   "
133815|NCT01303445|"~     The objective of the current study is to investigate if a drug-drug interaction occurs with~     the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of~     dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition~     (components of Aggrenox®) when administered every 12 hours at steady state.~   "
133816|NCT01303432|"~     The purpose of this study is to determine whether the daily eating of a yogurt supplemented~     with Mobile is effective in improving joint function and quality of life of individuals with~     low intensity gonalgia.~   "
133817|NCT01303419|"~     Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of~     an iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard~     mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of~     both sets of images will be performed either by one or the two readers. DE-CEDM will not be~     used to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or~     follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be~     based on histologic analysis of surgical specimens along with follow-up MX 10-15 months~     after the study exam. A randomized, blinded image evaluation will be done with 11 to 15~     radiologist readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.~   "
133850|NCT01302990|"~     This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter,~     dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single~     non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.~   "
133818|NCT01303406|"~     This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to~     further investigate the effects of idebenone in patients with Friedreich's ataxia.~      The objective of the PROTI study is to establish whether patients can correctly determine~     which treatment assignment (placebo or idebenone) they received during the randomised phase~     of the trial, and identify any potential changes on symptoms or activities.~   "
133819|NCT01303393|"~     Aim The overall aim was to investigate information needs after surgery for colorectal cancer~     and factors explaining information needs, both from the patients' perspective and the next~     of kin's.~   "
133820|NCT01303380|"~     This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics~     (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.~   "
133821|NCT01303367|"~     U.S. Food and Drug Administration (FDA) and other countries issue warnings on the off-label~     use of antipsychotics in demented patients with behavioral and psychological symptoms of~     dementia (BPSD) (FDA warning, 2003; 2005; 2008). There is a significant increase in~     mortality rate by 1.6 fold due to cardiovascular events and aspiration pneumonia in the~     demented patients received antipsychotics comparing to placebo group. However, the~     prescription rates of antipsychotics in demented patients are still increased by 20% after~     several alerts in Canada (Valiyeva et al., 2008).~   "
133822|NCT01303354|"~     The aim of this study is to assess the effectiveness and safety of dexamethasone for~     transforaminal epidural steroid injection. A secondary aim of this study is to obtain data~     on the lowest most effective dose of dexamethasone for this treatment and the effective~     duration of effect.~   "
133823|NCT01303341|"~     This phase I trial studies the side effects and best dose of sorafenib tosylate when given~     together with riluzole in treating patients with solid tumors or melanoma that has spread to~     other places in the body and usually cannot be cured or controlled with treatment. Riluzole~     may stop or slow the growth of tumor cells. Sorafenib tosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving riluzole together with~     sorafenib tosylate may kill more tumor cells.~   "
133824|NCT01303328|"~     The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel~     containing an antiviral, administered directly on cervix exhibiting high grade squamous or~     glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.~   "
133825|NCT01303315|"~     To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1~     agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2~     diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy~   "
133826|NCT01303302|"~     Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation~     using the TANTALUS System in the improvement of glycemic control measured by changes in~     HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be~     evaluated~   "
133827|NCT01303289|"~     The main objective of this trial is the clinical evaluation of a normoproteic diet, when~     this diet is used for total enteral nutrition in geriatric people.~      For 3 months,all the participants in the study will receive only tube feeding: The~     experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®,~     Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott~     Laboratories).~   "
133828|NCT01303276|"~     Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of~     central retinal vein occlusion, which is one of the most common retinal vascular disorders.~     Despite its clinical effectiveness, concerns remain regarding the systemic effects of the~     drug and previous studies have noted retinal arteriolar vasoconstriction following a~     ranibizumab injection. We aim to provide a physiological basis to these observations by~     assessing retinal blood flow before and after the ranibizumab injections. Specifically, we~     will assess the blood flow parameters (i.e. retinal vessel diameter, velocity & flow)~     immediately before the first injection and post-injection over a follow-up continued~     treatment period.~   "
133829|NCT01303263|"~     OBJECTIVE: To test a brief intervention designed to improve the cost-effectiveness of care~     provided by medicine housestaff for hospitalized patients.~      HYPOTHESIS: A brief intervention in which medicine residents receive itemized bills for~     recent patients cared for by them, followed by a discussion on approaches to reducing~     unnecessary inpatient costs, can result in significant cost reductions without adversely~     affecting patient outcomes.~   "
133830|NCT01303250|"~     The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl~     starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid~     management will be given to optimize the stroke volume variation <= 12%.~      The investigators hypothesize that patients in the intervention group will need less fluid~     administration be optimal hemodynamic stabilized.~   "
133831|NCT01303237|"~     This prospective, observational, multicentre, post marketing surveillance study will collect~     safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of~     the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the~     locally approved label.~   "
133832|NCT01303224|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor~     antagonist Ibodutant in improving IBS-D symptoms.~   "
133833|NCT01303211|"~     Major epidemics of meningococcal meningitis occur in countries of the African Sahel and~     sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to~     serogroup A. Until recently there has been no serogroup A conjugate vaccine available to~     prevent epidemics in Africa because none of the major pharmaceutical companies wanted to~     develop such a vaccine for commercial reasons. For this reason a public private partnership~     was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill~     and Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal~     conjugate vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification~     in 2010 and mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected~     that full coverage through mass vaccination campaigns will be achieved by the end of 2011 in~     these three countries. A case-control study will be conducted in Mali and Niger during the~     epidemic seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.~   "
133834|NCT01303198|"~     Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset~     T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual~     and automatical titration.~      Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and~     device data.~      Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.~   "
133835|NCT01303185|"~     The treatment options for nail psoriasis have been limited, and the management of nail~     psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser~     (PDL) in the treatment of nail psoriasis.~   "
133836|NCT01303172|"~     To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in~     combination with gemcitabine to gemcitabine alone on safety and tolerability (including~     QoL), clinical signs and symptoms of disease, selected markers of tumour burden and~     immunological status, and disease outcome.~   "
133837|NCT01303159|"~     The purpose of this study is to assess safety and ability of the endoscopic bipolar~     radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of~     cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat~     the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes~     coagulated and this may delay tumour growth and the time before the stent lumen becomes~     blocked. Thereby, allowing increased periods between the need for intervention and further~     stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open~     longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.~   "
133838|NCT01303146|"~     There is currently no effective treatment for late infantile MLD once clinical symptoms are~     evident. METAZYM is a recombinant human arylsulfatase A developed for an intravenous ERT for~     the treatment of late infantile MLD. The overall objective of this study is to evaluate the~     efficacy and safety of intravenous rhASA treatment in a patient with late infantile MLD who~     had previously received hematopoietic stem cell transplantation (HCT).~   "
133839|NCT01303133|"~     The primary objective of this study is to assess the presence of amyloid in~     non-demented/functionally stable adults with DS as a function of age, dividing the sample~     into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive~     measures across a range of areas that are often affected by AD.~   "
133840|NCT01303120|"~     The aim of this study is to compare the efficacy of the analgesic effect of the preoperative~     femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral~     cutaneous nerve blocks in patients after TKA in the immediate postoperative period.~   "
133841|NCT01303107|"~     The purpose of this study is to determine if the mixture of enantiomers of bupivacaine~     (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the~     racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).~   "
133842|NCT01303094|"~     This randomization discontinuation trial will allow for concomitant evaluation of the~     following:~        -  Side effects and benefits of immediate continuation of Trabectedin after the sixth~          cycle~        -  Side effects and benefits of a drug holiday~   "
133843|NCT01303081|"~     Financial incentives may be more effective than other approaches to smoking cessation, but~     research is needed to identify the optimal structures of incentives. The investigators will~     conduct a pilot randomized trial comparing different incentive structures for smoking~     cessation. Collaborating with Walgreens leadership, the investigators will enroll their~     employees in this RCT using the investigators new web-based research infrastructure (called~     the Way to Health platform, and approved as a Prime protocol by the IRB as reference #~     811860).~      Hypothesis: providing patients with financial incentives can promote healthier behaviors~     (e.g.: quit smoking).~   "
133844|NCT01303068|"~     The purpose of this study is to determine if inhaled urea can be used to detect the presence~     of Pseudomonas Aeruginosa in the lungs~   "
133845|NCT01303055|"~     It is reported that pancreatic beta cell function is already declined at pre-diabetic stage,~     impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the~     dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human~     pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen~     for treatments of type 2 diabetes and IGT.~      In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients~     whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted~     before, a year after, and two years after the beginning of the trial and beta cell function~     will be evaluated.~   "
133846|NCT01303042|"~     Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device.~     The management is comparatively simple and easy, but the curative effect is promising. It is~     also reported that noninferiority has been observed between basal/bolus therapy (BBT) and~     prandial premixed therapy (PPT, lispro mix 50/50 t.i.d.).~      The purpose of this study is to evaluate whether change of insulin therapy from BBT~     (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin~     therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro~     mix 50/50 t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.~   "
133847|NCT01303029|"~     The purpose of the study is to evaluate the efficacy of the combination of~     gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic~     pancreatic cancer.~   "
133848|NCT01303016|"~     The purpose of this research study is to better understand how to prevent malnutrition in~     children under age 5 years in Intibuca, Honduras. A randomized community trial design was~     used to implement a nutrition program, including a complementary nutrition supplement,~     educational sessions, and growth and health monitoring integrated into the basic primary~     care package, to participants living in communities in the intervention group. Participants~     living in the control group communities will receive the nutrition supplement for one year~     following the study.~   "
133849|NCT01303003|"~     Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal~     surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to~     prolong the effective duration of analgesia in several different peripheral nerve blocks.~     The study will examine, in a blinded, prospective and randomized fashion, whether the~     addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The~     study will compare local anesthetic with and without the addition of dexamethasone in the~     TAP block.~   "
133851|NCT01302977|"~     The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is~     higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal~     tracheal occlusion may increase lung volumes and therefore reducing the risk for severe~     pulmonary hypoplasia and by consequence the risk for neonatal death.~      The main objective of the present study is to evaluate if fetal tracheal occlusion improves~     survival rate in those cases that are followed in our hospital, by conducing a randomized~     trial.~   "
133852|NCT01302964|"~     This study will determine the effectiveness of mirtazapine in reducing anxiety in children~     with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.~   "
133853|NCT01302951|"~     The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF)~     in serum and liver tissue of patients undergoing liver resection due to primary or secondary~     tumor of the liver.~   "
133854|NCT01302938|"~     To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in~     subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative~     web-based trial design~   "
133855|NCT01302925|"~     The purpose of this phase 1 trial is to investigate the local tolerability on the finger~     following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3~     consecutive days.~   "
133856|NCT01302912|"~     Imaging techniques have considerably improved over the last decades and ocular adnexal~     lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and~     molecular diagnostics in histology have been achieved offering an accurate diagnosis, the~     investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes~     crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy~     accomplished great preciseness as well and OALs respond excellently to radiation, this~     therapy should be the treatment of choice in local defined lymphomas instead of blind~     treatment with steroids. Radiation results in great local control rates of 85% to 100%~        -  Trial with surgical intervention~   "
133857|NCT01302899|"~     The study is designed to primarily assess the effect of aliskiren on albuminuria in patients~     with non-diabetic nephropathy when treated with ramipril and volume intervention.~   "
133858|NCT01302886|"~     This study will assess the antimyeloma effects of BHQ880A in patients with smoldering~     multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be~     administered every 28 days in previously untreated patients. Disease assessments will be~     performed monthly and effects on bone metabolism will be assessed by measurement of serum~     and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile~     of BHQ880 as a single agent and following multiple doses will be obtained.~   "
133859|NCT01302873|"~     This study will assess the efficacy of a two week treatment with BGG492 in patients with~     chronic subjective Tinnitus.~   "
133860|NCT01302860|"~     This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4~     years and younger with cryopyrin associated periodic syndromes (CAPS)~   "
133861|NCT01302847|"~     Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study will~     test the safety of and immune response to DTG in HIV-1 infected infants, children, and~     adolescents.~   "
133862|NCT01302834|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether radiation therapy is~     more effective with cisplatin or cetuximab in treating oropharyngeal cancer.~      PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to~     see how well it works in treating patients with oropharyngeal cancer.~   "
133863|NCT01302821|"~     The purpose of this research project is to create images of where and how the amino acid~     (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in~     the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes~     in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible~     treatments for this abnormality are of great interest because of the potential to improve~     cancer care.~   "
133864|NCT01302808|"~     RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when~     given together with erlotinib hydrochloride and to see how well they work in treating~     patients with stage III or stage IV non-small cell lung cancer.~   "
133865|NCT01302795|"~     This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of~     subjects with pyoderma gangrenosum.~   "
133866|NCT01302782|"~     The purpose of this research study is to observe whether there is a change in blood glucose~     levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric~     hypoxia (short term low oxygen levels at normal ambient air pressure).~   "
133867|NCT01302769|"~     The purpose of this study is to compare ear acupuncture plus standard of care versus~     standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral~     anti inflammatory medication use, hours lost from work in acute sore throat.~   "
133868|NCT01302756|"~     The purpose of this study is to determine if higher-than usual doses of daily folic acid has~     an effect on the rate of gestational diabetes mellitus (GDM) or gestational hypertension in~     pregnant women while determining status of folic acid, vitamin B12, homocysteine and vitamin~     D in pregnancy.~   "
133869|NCT01302743|"~     The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an~     effective nutraceutical for the initial treatment of diabetes when compared to standard~     therapy of Metformin.~   "
133870|NCT01302730|"~     This study aims to test whether a new instrument (questionnaire) is useful for identifying~     patients with ankylosing spondylitis.~   "
133871|NCT01302717|"~     In this study, the investigators will examine whether left ventricular pacing is superior to~     right ventricular apical pacing in preventing deterioration of left ventricular systolic~     function and cardiac remodeling in patients with bradycardia with high risk for development~     of pacing-induced heart failure.~   "
133873|NCT01302691|"~     This study is being done to evaluate the efficacy, safety, and tolerability of losartan~     potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5)~     (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean~     trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to~     L50+A5 in Japanese participants with essential hypertension who are not adequately~     controlled following an 8-week treatment with filter period study drug (L50+A5).~   "
133874|NCT01302652|"~     The purpose of this research study is to study the effects of growth hormone (GH)~     replacement on the heart. The investigators will study these effects in people who have been~     cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough~     growth hormone).~   "
133875|NCT01302639|"~     There are strong indications that (combinations of) polyphenols may be attractive candidates~     in the prevention of the metabolic syndrome and diabetes through modulation of pathways of~     fatty acid metabolism and mitochondrial function. We hypothesize that the combination of~     specific polyphenols, with partly distinct mechanisms of action, may have physiologically~     significant effects on fat oxidation through additive or synergistic effects, thereby~     improving body composition, insulin sensitivity and preventing type 2 diabetes. The~     following objective will be addressed in the current study:~      (1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG~     either in combination with resveratrol or with resveratrol and genistein) to affect systemic~     lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high~     fat meal in overweight subjects~   "
133876|NCT01302626|"~     Aim of the study: The main aim is to collect data of patients with lung cancer, and to~     perform different analyses on this data. The data contains information on patient and tumor~     characteristics, imaging, and treatment characteristics. With this data it is possible to~     improve and validate the predictive model for survival and long term toxicity in lung cancer~     by multicentric prospective data collection. The long term aim, beyond this specific study,~     is to build a Decision Support System based on the predictive models validated in this~     study.~      Hypothesis: The general hypothesis is that we get a better prediction in terms of AUC (area~     under the curve) of survival and long term toxicity when we combine multifactorial~     variables. These variables consist of information from clinical data, imaging data, data~     related to treatment type and treatment quality.~   "
133877|NCT01302613|"~     The primary objective of the pilot portion of this study is to establish the safety and~     tolerability of an extended treatment break period in patients who have undergone~     neoadjuvant chemoradiotherapy as well as use of systemic therapy during this break.~   "
133878|NCT01302600|"~     Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant~     patients aged 3-25 years~   "
133879|NCT01302587|"~     This study is evaluating the effectiveness of a dose counter for an inhaler device used to~     deliver medication to people diagnosed with asthma or COPD.~   "
133880|NCT01302574|"~     The purpose of this study is to determine the functional significance of sweet taste~     receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific~     sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal~     tract.~   "
133881|NCT01302561|"~     The purpose of this research study is to determine whether a functional fiber,~     galactooligosaccharide, can help maintain immune strength and digestive health in~     free-living older adults. It is hypothesized that older adults consuming the fiber daily for~     24 weeks over cold and flu season will have more healthy days due to a proliferation of~     beneficial bacteria within the colon which alters cytokine production and enhances natural~     killer cell function. Immune and gastrointestinal health will be evaluated via daily~     questionnaires obtained from 80 participants and from the collection of blood and fecal~     samples.~   "
133882|NCT01302548|"~     The purpose of this study is to determine if wound cleansing and irrigation using the~     IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized~     stream, will improve the outcome for infected abscesses in patients that present in the~     emergency department.~   "
133883|NCT01302535|"~     The purpose of this study is to determine the effects of yoga on blood pressure and quality~     of life in patients in primary health care diagnosed with hypertension within the last year.~     Another purpose is to examine whether the possible effect on blood pressure differs if~     patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises~     from their doctor to be practiced individually at home.~   "
133884|NCT01302522|"~     Spinal cord injury (SCI) is a disabling condition that impairs fundamental abilities, such~     as ambulation, respiration, and toileting. Compromised ambulation is a common, devastating~     impairment following SCI. Yet, despite the fundamental desire to walk, no conventional~     rehabilitation regimen reliably improves ambulation after SCI, and many SCI patients do not~     have reliable transportation access, decreasing community integration and access to needed~     services, including rehabilitation. Little is also known about the subtle neural events that~     may predict motor recovery in incomplete SCI patients. This study will test a novel, safe,~     easy to implement technique that has shown promise in improving gait in incomplete SCI~     patients. The investigators expect that this study will confirm the efficacy of this~     technique, by showing that it increases the speed and efficiency of walking. This outcome is~     expected to produce a therapy that improves outcomes and health, and reduces care costs, for~     community dwelling patients with incomplete SCI.~   "
133885|NCT01302509|"~     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status~     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition~     indications, as well as its compliance and the impact on nutritional status.~      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year~     followed during anticancer therapy were included from January 2002 to January 2004. They~     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a~     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was~     observed, tube feeding with the same supplement (TFR) was indicated.~   "
133908|NCT01302210|"~     Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization~     risk from nearly all residents (patients) in a way that does not interfere with the desired~     life-style for persons in these facilities and thereby reduce the risk of infection and~     lower the cost of care by avoiding preventable disease.~   "
133886|NCT01302496|"~     The CTLA-4 blocking monoclonal antibody ipilimumab (MDX-010, BMS-734016), has demonstrated~     anti-tumor activity in a subgroup of patients with Stage III (unresectable) or Stage IV~     melanoma (measurable per modified WHO criteria), who have received prior treatment with any~     regimen (non-experimental or experimental), except a CD-137 agonist or a CTLA4 inhibitor or~     agonist and relapsed, failed to respond (CR or PR) or did not tolerate that regimen~     (Wolchok, Neyns et al. 2009; O'Day, Maio et al. 2010). Ipilimumab exerts its therapeutic~     effect presumably by activating T-lymphocytes that infiltrate the tumor mass to destroy the~     malignant cells by mechanisms of cytotoxic cellular interaction. Autologous TriMix-DC~     vaccine can induce a T-cell repertoire that recognizes in a HLA-restricted way the melanoma~     associated antigens MAGE-A3, MAGE-C2, tyrosinase and gp100. Administration of ipilimumab~     together with TriMix-DC vaccine therapy may be a more effective treatment for patients with~     advanced melanoma as compared to either modality alone.~   "
133887|NCT01302483|"~     The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3%~     tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for~     dental procedures.~   "
133888|NCT01302470|"~     The primary goal of this study is to evaluate the use of robotically -assisted device leads~     as a primary strategy for heart resynchronization.This trials aims to compare transvenous~     lead placement with robotic lead placement for cardiac resynchronization therapy.~   "
133889|NCT01302457|"~     There have been multiple articles done regarding oral hygiene on patients in burn and~     intensive care patients. All articles agree the need for good oral hygiene in these special~     needs patients. They also note that more research needs to be done on this subject, yet have~     no direction of how to proceed in this research. Currently, no research has been done on the~     burn/intensive care patient to see if there is a difference form the non-hospitalized~     patient which oral hygiene protocol is based on.~   "
133890|NCT01302444|"~     Objectives: To test whether the combined administration of the medications treprostinil(a~     prostacycline therapy), and tadalafil(a PDE-5 [ phosphodiesterase type 5]Inhibitor therapy)~     is better than the administration of treprostinil alone. This treatment would be offered to~     newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for~     this disease and are deemed candidates for the medication treprostinil by their physician.~     The combination therapy will be compared to single therapy with only treprostinil in a~     double-blind manner.~      Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline,~     depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and~     add additional therapies as deterioration occurs. This treatment could add two agents~     initially.~      Secondary objectives are: To improve pulmonary arterial pressures as measured through a~     cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to~     clinical worsening, and lowering plasma BNP levels.~      Research Procedures: To begin the administration of both treatments at the same time.~      Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic~     physician exams, and lab work will be followed. Subjects will be between the ages of 18 -~     75.~   "
133891|NCT01302431|"~     The primary aim of this study is to determine if a manual based telephone intervention~     support service for people who support people with Multiple Sclerosis (PwMS), initiated by~     nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and~     their support persons. For support persons this impact is determined by measurable support~     person/carer self-efficacy and preparedness to care, burden, quality of life, service~     utilization and satisfaction with the support service. For PwMS this is determined by their~     qualitative experience of the type of care they receive from their carer. A secondary aim is~     to determine the possible economic benefits of the introduction of such an intervention~     nationally. A support person is the person nominated by the PwMS as the person who provides~     the most support or physical assistance to a person with MS who is not a paid service~     provider.~   "
133892|NCT01302418|"~     The study will be conducted using nasopharyngeal swab specimens collected prospectively from~     individuals suspected of having the signs and symptoms of an acute respiratory tract~     infection caused by a respiratory virus. A series of standard viral culture tests validated~     for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory~     Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify~     the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN~     ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a)~     one aliquot will be tested in real-time using the assigned viral culture reference methods;~     (b) one aliquot will be used to extract nucleic acid in real-time for investigational~     testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to~     the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for~     subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of~     positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen~     Study. The extracted nucleic acid generated from the second aliquot (i.e., b above) will~     be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the~     ResPlex II Advanced Panel test.~   "
133893|NCT01302405|"~     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have~     advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that~     cancer cells need to grow and spread(metastasize).~      Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating~     doses (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen.~     PRI-724 dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.~      Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts~     with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in~     combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule)~     in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to~     be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to~     evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize~     tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12~     patients.~   "
133894|NCT01302392|"~     This is a Phase 3, randomized, open-label, multicenter study comparing two treatment~     regimens for subjects with multiple myeloma who have received all available approved~     treatment options and may therefore be considered candidates for palliative care.~   "
133895|NCT01302379|"~     This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle~     intervention and metformin (a drug used to treat diabetes) to investigate how these~     treatments, alone or in combination, affect biomarkers associated with breast cancer~     survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast~     cancer survivors. After completing the screening process and baseline measures, participants~     will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle~     intervention and placebo, or (4) lifestyle intervention and metformin. The interventions~     will last for 6 months. Concentrations of circulating biomarkers will be assessed at~     baseline and 6 months.~   "
133896|NCT01302366|"~     This study proposes to determine the clinical activity of this agent in patients with~     asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active~     multiple myeloma, with very few-if any- side effects.~   "
133897|NCT01302353|"~     In this trial, our primary goal is to investigate the safety of intravenous infusion of~     emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified~     Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of~     acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop~     severe adverse event in any dose group or any volunteer develop fatal adverse event in any~     group.~   "
133898|NCT01302340|"~     Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all~     patients with dementia will experience neuropsychiatric symptoms (NPS). This causes~     significant burden for the individual patients and their caregivers. Current treatment has~     only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol~     (THC), the psycho-active compound of cannabis, are currently being registered for spasms in~     multiple sclerosis and other diseases, and may have beneficial effects on NPS.~   "
133899|NCT01302327|"~     Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic~     atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and~     apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating~     evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's~     syndrome results from a high level of ER stress in affected cells. The current treatment of~     Wolfram syndrome is insulin, which fails to prevent the progression of beta-cell failure.~      Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from~     ER stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the~     treatment of patients with Wolfram syndrome.~      The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function~     and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function~     will be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after~     3 month of treatment.~   "
133900|NCT01302314|"~     This study will examine the effects of a theoretically grounded and manualized cognitive~     rehabilitation program on patients with Spina Bifida (SB). SB is often associated with~     deficit in higher order control over cognition, emotion and behaviour; which is typically~     referred to as executive functions. The present study will examine the efficacy of Goal~     Management Training (GMT) in patients with SB that experience executive difficulties. It is~     expected that GMT will have a favourable effect on cognitive executive functioning,~     psychological and health related factors.~   "
133901|NCT01302301|"~     Achalasia and esophageal spasm are primary esophageal motility disorders where the lower~     esophageal sphincter fails to relax in response to swallowing with no well understood~     underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose~     of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to~     overcome the need for invasive surgery.~   "
133902|NCT01302288|"~     Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter~     fails to relax in response to swallowing with no well understood underlying cause. Surgical~     myotomy represents an appropriate therapeutic option. The purpose of this study is to~     evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for~     invasive surgery.~   "
133903|NCT01302275|"~     The purpose of this trial is to determine if the effect of oxcarbazepine on chronic~     peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine~     mainly relieve pain in patients with irritable nerves.~   "
133904|NCT01302262|"~     This study will evaluate effects of smoking on the dopaminergic system by using PET~     tomography with new radioligand, [11C]-(+)-PHNO. Our primary hypothesis is that smoking a~     cigarette will produce dopamine release and this release can be measured using PET imaging~     and the [11C]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced~     dopamine release will be correlated with subjective craving and anxiety ratings.~   "
133905|NCT01302249|"~     This is a double-masked, randomized, multi-center, active-controlled, crossover comparison~     of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated~     intraocular pressure (IOP).~   "
133906|NCT01302236|"~     The purpose of this study is to determine whether eplerenone is effective in the treatment~     of blood pressure, heart function, renal function in elderly hypertensive stage1~     (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) chronic kidney disease (CKD)~     patients.~   "
133907|NCT01302223|"~     KERATINOCYTE GROWTH FACTOR AND CYTOKINES IN SKIN BURNS.~      INTRODUCTION: Intense inflammatory responses are activated by burns that affect a large~     total body surface area. Changes in plasma levels of cytokines after burns occur before~     metabolic abnormalities unsettle the patient. So it may be possible to develop therapeutic~     interventions that may attenuate the acute inflammatory response by decreasing the~     expression of these cytokines. The importance of growth factors in the healing process was~     demonstrated in cultured keratinocytes and fibroblasts. The keratinocyte growth factor (KGF)~     is a growth factor active in the repair of wounds, being the most potent stimulator of~     mitotic cells.~      PURPOSE: To assess the level of keratinocyte growth factor (KGF) and IL-1ß, IL-6, IL-8,~     IL-10, IL-12 and TNF-alfa of patients with burns produced by cultured primary dermal~     fibroblasts and the gene expression.~      METHODS: 10 patients will be include (05 patients in the study group and 05 patients in the~     control group) admitted to the Burns Care Unit of the Discipline of Plastic Surgery, Federal~     University of São Paulo (UNIFESP) between 25% and 50% of total body surface area (TBSA),~     deep second-degree or third degree, with need to perform surgical debridement. The control~     group will be constituted by patients with less than 5% of TBSA, deep second-degree or third~     degree, with need to perform surgical debridement. The authors will evaluate the levels of~     IL-1ß, IL-6, IL-8, IL-10, IL-12p70 and tumor necrosis factor alpha (TNF-alfa) in samples of~     the culture media of primary dermal fibroblasts of patients selected using flow cytometry.~     The level of keratinocyte growth factor (KGF), in the same samples will be evaluated by~     ELISA. The keratinocyte growth factor (KGF) and TNF-alfa gene expression will be evaluated~     in the culture of primary dermal fibroblasts from the same patients. The gene expression of~     KGF and cytokines will be done by qRT-PCR and RT-PCR array. The experiments will be done in~     duplicate.~   "
133909|NCT01302197|"~     Stroke, a leading cause of disability in the aging population, increases the risk for~     diabetes, subsequent stroke recurrence, and cardiovascular disease complications. The~     downsizing of private and federal health care resources, along with the anticipated increase~     in stroke rates as our population ages, mandate that alternative strategies be developed to~     reduce the public health burden of stroke. This pilot study may facilitate our knowledge of~     the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening~     of glucose tolerance after stroke. Knowledge of the skeletal muscle changes occurring in the~     sub-acute stroke period is essential to create new guidelines incorporating exercise~     rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the~     health care of veteran stroke survivors.~   "
133910|NCT01302184|"~     Gait rehabilitation with treadmill has been reported to be useful in patients with~     Parkinson's disease. In the last years, interest in robotic devices for gait training has~     grew up for patients with different neurological disorders, since they minimize demands on~     physical therapists and may provide a more reliable and constant treatment.~      The aim of this study is to evaluate if robotic gait training with Lokomat® can improve~     walking more than conventional gait training with treadmill in patients affected by~     Parkinson's disease.~   "
133911|NCT01302171|"~     A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary~     injection of progenitor cells compared to placebo injection in patients with Dilated~     Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and~     patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to~     placebo injection~   "
133912|NCT01302158|"~     A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of~     glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics,~     safety and pharmacodynamics of ASP1941 (Part B).~   "
133913|NCT01302145|"~     A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when~     ASP1941 is administered as add-on therapy to metformin.~   "
133914|NCT01302132|"~     This study investigates the pharmacokinetics, in particular the routes and extent of~     metabolism and excretion, of ASP1941 after a single oral dose.~   "
133915|NCT01302119|"~     The purpose of this study is to determine whether AN2690 topical solution is a safe and~     effective treatment for onychomycosis of the toenail.~   "
133916|NCT01302106|"~     This is an interventional, multicenter, open label, phase II study designed to evaluate the~     safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated~     patients with poor risk of Myelodisplastic Syndromes.~   "
133917|NCT01302093|"~     This study is designed to assess bioequivalence between two products used for treatment of~     acute diarrhea.~   "
133918|NCT01302080|"~     To evaluate the long-term impact of treatment with sertraline on aspects of cognitive,~     emotional and physical development and pubertal maturation in pediatric subjects ages 6 to~     16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive~     compulsive disorder.~   "
133919|NCT01302067|"~     This study is designed to confirm if 8mg of fesoterodine is more effective in reducing~     overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to~     assess if the higher dose reduces the overall effect of overactive bladder on the subject's~     daily life more than the lower dose. The study also assesses the side effects and safety of~     the two doses.~   "
133920|NCT01302054|"~     Patients with overactive bladder are often treated with tolterodine, a medication that helps~     relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes~     patients do not have a satisfactory response, and may benefit from trying an alternative~     oral medicine. Fesoterodine is related to tolterodine by producing the same active substance~     that acts on the bladder, but potentially at higher and more effective levels. So, a patient~     who has a poor response to tolterodine may still obtain a good response to fesoterodine.~     This study will help find out if this is what happens.~   "
133921|NCT01302041|"~     To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with~     prostate cancer.~   "
133922|NCT01302028|"~     A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes~     Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients~     with normal renal function and healthy volunteers.~   "
133923|NCT01302015|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     Buerger's disease.~   "
133924|NCT01302002|"~     The study will test metformin in patients with early breast cancer. Blood and tissue will be~     collected before and after the use of metformin.~   "
133925|NCT01301989|"~     Inadequate sleep is a major health problem of childhood that often fails to receive~     attention until significant neurobehavioral and other health problems are noted. Although~     adequate sleep is essential for normal growth and brain development, studies show that~     children from minority and economically disadvantaged families are more likely to experience~     shorter sleep times and more sleep fragmentation compared to their Caucasian and~     economically advantaged counterparts. As a result, they are disproportionately affected by~     the adverse health and quality of life consequences of poor sleep. There are currently no~     intervention studies to the investigators knowledge aimed at addressing sleep disparities by~     improving sleep duration and sleep hygiene in early school-aged children from minority~     populations. This study seeks to close the 'sleep gap' that exists between the sleep~     duration of minority school-aged children and that of their non-minority peers. An~     interdisciplinary team of researchers and clinicians from Columbia University's Pediatric~     Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two~     outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep~     disparities by improving sleep duration in a group of 5-6 year old minority children. The~     primary goal of this study is to evaluate the efficacy of a tailored, interactive,~     educational and behavioral intervention that utilizes trained sleep counselors to assist~     parents in improving their children's sleep hygiene and reducing risk factors for poor~     sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled~     trial of children identified with sleep problems (Aim 1). The investigators will screen 375~     parents of 5-6 year old children from 5 primary care clinics to identify children with and~     without sleep problems and enroll 90 of the 375 children screened who have sleep problems in~     a randomized controlled trial of an in-home sleep intervention. Using an initial home~     assessment, baseline actigraphy data, sleep logs recorded by parents, and information~     regarding risk factors for poor sleep collected from each family during screening, the~     investigators will work with intervention parents to develop a personalized sleep plan for~     their children. The investigators will evaluate the effect of the intervention on: a)~     nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.~   "
133926|NCT01301976|"~     The purpose of this study is to determine the reason patients are deficient in nutrients~     intake such as antioxidants vitamins.~   "
134420|NCT01295437|"~     Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of~     this study was to compare long-term results of hernioplasty using three different meshes~     (partly absorbable, lightweight polypropylene and thick polypropylene mesh).~   "
133927|NCT01301963|"~     This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating~     patients with multiple myeloma (MM) previously treated with lenalidomide. Giving~     colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the~     patient's bone marrow to the blood so they can be collected and stored~   "
133928|NCT01301950|"~     This study is designed to compare the surgical efficiency of TruMatch® Personalized~     Solutions surgical technique compared to conventional surgical technique. Specifically, the~     purpose of this study is to collect time data to enhance the existing economic model.~   "
133929|NCT01301937|"~     Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between~     the standard and alternative schemes with meglumine antimoniate has begun in October 2008~     at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research~     Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended~     schedule with an alternative regimen of meglumine antimoniate (MA) in the treatment of~     mucosal or mucocutaneous leishmaniasis (ML or MCL)). It is a study with blind evaluation by~     the doctors and the responsible for statistical analysis. Patients diagnosed with Ml or MCL,~     eligible for the trial, are randomly allocated into one of the schemes with meglumine~     antimoniate and monitored before, during and after it. There is no single regimen applicable~     to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people~     living in other geographic areas result in mixed outcomes. Ideally, the most appropriate~     regimens should be established for each endemic area, based on its efficacy, toxicity,~     difficulties of administration and cost. Given the problems and limitations of the use of~     pentavalent antimonials at 20 mg / kg / day, a less toxic alternative regimen with~     5mg/kg/day, continuous up to the cure deserves to be better evaluated. Treatment must lead~     to the healing of mucosal lesions and prevent late scarring tissues and disabilities~     development. The indication of high doses of MA is based on the evidence that there could be~     induction of resistance with use of subdoses. However, clinical studies with extended~     follow-up in Rio de Janeiro have suggested that regular low MA doses (5mg / kg / day) in a~     systemic way may constitute an effective scheme, achieving cure rates similar to higher~     dose, with lower toxicity, ease of implementation and lower cost. Published studies on~     efficacy and safety of alternative schemes with meglumine antimoniate failed to provide~     conclusive results, for various methodological biases. The need to compare the effectiveness~     and safety between treatment schemes with meglumine antimoniate currently recommended in~     Brazil for the treatment of ML or MCL and an alternative scheme with low dose of antimony is~     the motive for this study in Rio de Janeiro.~   "
133930|NCT01301924|"~     Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and~     Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis  has begun~     in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical~     Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard~     recommended schedule with an alternative dosage scheme of meglumine antimoniate in the~     treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation~     by the doctors and the responsible for statistical analysis. Patients diagnosed with ATL,~     eligible for the trial are randomly allocated into one of the schemes with meglumine~     antimoniate and monitored before, during and after it. There is no single regimen applicable~     to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people~     living in other geographic areas result in mixed outcomes. Ideally, the most appropriate~     regimens should be established for each endemic area, based on its efficacy, toxicity,~     difficulties of administration and cost. Given the problems and limitations of the use of~     pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens,~     i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin~     lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is~     based on the evidence that there could be induction of resistance with use of subdoses.~     However, clinical studies with extended follow-up in Rio de Janeiro have suggested that~     regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure~     rates similar to higher doses, with lower toxicity, ease of implementation and lower cost.~     Published studies on efficacy and safety of alternative dosage schemes with meglumine~     antimoniate failed to provide conclusive results so far, for various methodological biases.~     The need to compare the effectiveness and safety between the standard treatment scheme with~     meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an~     alternative scheme with low doses of antimony is the motive for this study in Rio de~     Janeiro.~   "
133931|NCT01301911|"~     Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.~     This study is designed to evaluate the safety and tolerability of cipatinib in patients with~     HER2 positive or uncertain advanced breast cancer:~        1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose~          (MTD) and dose-limiting toxicity (DLT)~        2. To determine the pharmacokinetic profile of cipatinib and its metabolites~        3. To assess preliminary antitumor activity~        4. To determine preliminary regimen for phase II study~        5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.~   "
133932|NCT01301898|"~     The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant~     human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients~   "
133933|NCT01301885|"~     Endometriosis is a chronic disease characterized by the presence of functional endometrial~     glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial~     tissue responds to estradiol and other hormones similarly to the normal endometrium.~     Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of~     women in the reproductive age may be affected. In addition to pain which may be severe,~     subfertility is one of the typical problems associated with endometriosis and may be present~     in up to 40% of those affected. There is lack of a clear correlation between severity of~     pain and degree of compromised fertility. Different modes of treatment exist. Hormonal~     treatments are based on the suppression of estrogenic action on endometriosis as well as the~     endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a~     rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of~     time, however, curative treatment frequently involves hysterectomy with bilateral~     oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of~     novel pharmacological agents would be of crucial importance. Presently, endometriosis can be~     reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new~     diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is~     presently impossible to predict, new markers for the malignancy of each case are~     desperately needed.~      The aim of the investigators research is to identify expression of endometriosis specific~     RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium~     of patients with careful clinical and surgical classification of endometriosis as well as~     healthy control women should initially enable to identify novel targets for new therapies~     and biomarkers. Furthermore, combined with an adequate follow up, the study should enable~     for example to identify markers for endometriosis associated infertility as well as cases~     where the disease progresses very rapidly. Different forms of effective treatment may~     thereafter be designed following the identification of such factors.~   "
133947|NCT01301703|"~     Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent~     B. pertussis infection between 8%--26% have been reported among adults with cough illness of~     at least 5 days duration who sought medical care. The CDC recommends vaccinating patients~     aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have~     been evaluated in healthy population, the safety and efficacy of this vaccine in patients~     suffering from rheumatic diseases have not been established.~      Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls~      Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of~     safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood~     will be drawn at each visit at tested for humoral response to tetanus and pertussis.~   "
134041|NCT01300455|"~     This study will evaluate the safety, tolerability, and effect of multiple doses of~     suvorexant (MK-4305) on respiratory function in participants with mild to moderate~     obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis~     of this study is that multiple doses of MK-4305 do not produce a clinically significant~     increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as~     compared to placebo.~   "
133934|NCT01301872|"~     During the past two decades, there current concept has evolved significantly that~     ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and~     subsequent injury to the lungs, but may also induce local as well as systemic inflammation~     responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic~     inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory~     hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury~     score of 2.5 or less, receiving ventilation with lung protective strategy involving low~     tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic~     cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et~     al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with~     ARDS within 1 hour after switching the patients from a protective to non-protective~     ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently~     identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies~     showed that the plasma level of RAGE was associated with severity of lung injury and~     clinical outcome, and low tidal volume strategy ventilation accelerated the decline in~     plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of~     alveolar epithelial injury in acute lung injury and may associated with ventilator induced~     lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS~     emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung~     overdistension and ventilator associated lung injury (VILI)7; however, in the real world,~     some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in~     modern time, and was noticed only in patients with greater lung injury scores8. The benefit~     of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe~     ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions~     is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially~     promising markers, the receptor for advanced glycation end-product (RAGE) is of great~     interest.~      We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI~     patients with good compliance may be beneficial to this patient population. Therefore, we~     wish to propose a prospective single-center study to investigate the effect of mechanical~     ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute~     lung injury.~   "
133935|NCT01301859|"~     The study is a randomized controlled trial to test the usefulness of a brief intervention to~     improve adherence to antidepressant medication prescribed to older adults in a primary care~     setting. Study will be conducted at Weill Cornell and University of Michigan.~   "
133936|NCT01301846|"~     To explore the relationship between ability to do different wheelchair skills and the~     participation and quality of life of wheelchair users in and around their home and~     community. The investigators study hypothesis:~        1. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is~          strongly related to self-reported participation.~        2. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is~          related to the average daily distance traveled in their wheelchair.~   "
133937|NCT01301833|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin)~     as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2~     Diabetes for 52 weeks administration.~   "
133938|NCT01301820|"~     Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of~     a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit~     Patients With Poor Prognosis Acute Myeloid Leukemia (AML).~      The disease-free survival (DFS) of the patients included in this study will be compared to~     the ones of the two previously reported groups of patients treated with the same LIA~     induction therapy~   "
133939|NCT01301807|"~     The goal of this clinical research study is to find the highest tolerable dose levels of~     carfilzomib and LBH589 (panobinostat) that can be given in combination to patients with~     myeloma. The safety of this drug combination will also be studied.~   "
133940|NCT01301794|"~     High levels of triglycerides is a common abnormality found in patients with diabetes and~     also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids,~     as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride~     levels. Prior work from the investigators group demonstrated that an enzyme responsible for~     the break down of triglycerides - lipoprotein lipase - generates molecules that can activate~     a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that~     taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins~     and increases the ability of those lipoproteins to activate PPAR-alpha.~   "
133941|NCT01301781|"~     A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated~     adults.~   "
133942|NCT01301768|"~     The purpose of this study is to assess the effectiveness of individual education versus~     group education about dietary habits and iodine supplementation to decrease iodine~     deficiency in pregnant women~   "
133943|NCT01301755|"~     Invasive aspergillosis is a serious and often fatal infection in patients who are~     neutropenic or have undergone solid organ or stem cell transplantation. However, early~     diagnosis of invasive aspergillosis is a challenge. Reiss and Lehmann first described the~     value of serum Galactomanna (GM) for diagnosis of invasive pulmonary aspergillosis in 1979.~     The availability of the Platelia Aspergillus, a sandwich ELISA that has been approved by FDA~     in 2003 for managing patients at risk of invasive aspergillosis because of the early~     detection of the GM antigen. In several studies so far the specificity of the serum~     galactomannan assay was greater than 85%; however, variable sensitivity from 29~100% was~     noted over years. In addition, low values and false-negative results are seen more often in~     nonneutropenic and solid organ transplantation patients as opposed to severely~     granulocytopenic patients .There are several factors that might explain the reported~     difference in the performance of antigen detection, including the biological factors and~     epidemiological factors.~      In recent years, specimens of other body fluids are increasingly used for detection of~     Aspergillus galactomannan antigen, including urine, bronchoalveolar lavage(BAL) fluid,~     cerebrospinal fluid and even the tissue specimen. However, the sensitivity and specificity~     of the GM detection in various specimens still have considerably variation.~     Ultrasound-guided transthoracic aspirate is a safe and useful method for collecting~     specimens for accurate bacteriologic diagnosis of lung abscess and obstructive~     pneumonitis10. We also reported a study of diagnosis of pulmonary Cryptococosis by~     ultrasound guided percutaneous aspiration. We plan to perform a prospective single-center~     study to investigate the role of GM in the target organ (lung tissue/fluid) by using~     ultrasound-guided fine needle aspirate for early diagnosis invasive aspergillosis compared~     with the serum galactomannan.~   "
133944|NCT01301742|"~     To investigate the relative bioavailability of BI 10773 following coadministration with 600~     mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.~   "
133945|NCT01301729|"~     This single arm, open-label study will evaluate the efficacy and safety of Herceptin~     (trastuzumab) in combination with a taxane as first line therapy in participants with~     HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment.~     Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv~     weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or~     paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease~     progression or unacceptable toxicity occurs.~   "
133946|NCT01301716|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and~     carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with~     locally advanced or metastatic solid tumors.~   "
133999|NCT01301014|"~     This study is investigating the reliability and diagnostic accuracy of a Lachman's test~     conducted in a prone position to detect the presence of a torn anterior cruciate ligament.~   "
133948|NCT01301690|"~     3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical~     compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different.~     Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained~     cells was established to instantly differentiate cancer cells from normal cells. The~     investigators want to quantitatively measure the fluorescence expression of BMVC in normal~     and cancer cells and explore the usefulness of this staining in head and neck lumps.~   "
133949|NCT01301677|"~     Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled~     study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR)~     induced signs of inflammation (erythema and pain) in healthy volunteers.~   "
133950|NCT01301664|"~     In this study, the investigators explored the hypothesis that osteoarthritic cartilage~     fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were~     harvested from one osteoarthritic patient during the total knee arthroplasty surgery.~     Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were~     implanted subcutaneously into nude mice.~      Moreover, the investigators will collect the discard cartilage to develop an acellular~     cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the~     investigators will harvest the redundant bone marrow from drilling or useless synovium~     during the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal~     stem cells will be transfected with hTERT for rejuvenation and then will be labeled with~     fluorescent dye PKH26 for application of animal study. To sum up, the investigators plan to~     use human, natural, and discard materials from the joint replacement surgery to develop~     appropriate allograft for cartilage repair and hope that one day this ideal would be apply~     in clinical.~   "
133951|NCT01301651|"~     Background and Objective: Postural instability is common in patient with Parkinson's disease~     (PD). The purpose of this study was to investigate the effects of virtual reality (VR)~     balance training on sensory and cognitive domains of postural control.~      Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and~     Yahr stage II-III) were recruited and assigned into three groups randomly.~      Intervention: Participants in the virtual reality (VR) group and conventional balance~     training (CB) group received a 6 weeks balance training program. The control group (CG) did~     not receive any training.~      Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography~     with single and dual tasks (i.e. with backward subtraction of number) were examined pre-,~     post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The~     verbal reaction time (VRT) was recorded.~      Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at~     visual and somatosensory conflicting condition) post-training more than CG post-training in~     either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e.,~     vestibular function without visual conflict) and vestibular sensory ratio (i.e.,~     SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR~     nor CB training reduced VRT significantly under six sensory conditions at post-training and~     follow-up.~      Conclusion: Both VR training and CB training can improve sensory organization for postural~     control by enhancing utilization of vestibular information, but VR could enhance vestibular~     function with conflicting proprioceptive and visual information under single and dual tasks~     in patients with mild to moderate PD.~   "
133952|NCT01301638|"~     Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale~     clinical trials conducted that included more than 1,000 subjects and than Daptomycin got~     complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got~     new indications about bacteremia and endocarditis due to success outcomes in the clinical~     trial which included infected in blood flow and endocardial infected patients.~      All subjects in Daptomycin clinical trials are European and American race. It is necessary~     that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to~     evaluate the safety and efficacy of Daptomycin which were used in patients with serious~     gram-positive infections retrospectively. And the outcome could be a reference for~     Daptomycin future using.~   "
133953|NCT01301625|"~     The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world~     clinical and health-economic outcome data to support the long-term safety, efficacy and~     economic value of the MitraClip System in the continuum of therapies for treating MR.~     Specifically, the following clinical and economic data will be collected: New York Heart~     Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life~     (QOL) information, echocardiographic measures of left ventricular size and function, and~     data associated with the index hospitalization, rehospitalizations, concomitant medications~     and discharge facility to support the MitraClip System economic analysis.~   "
133954|NCT01301612|"~     The primary study objective will be to assess the efficacy of the combination of radiation~     therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy~     plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC).~      The secondary study objectives will be safety and tolerability evaluations, to determine~     treatment feasibility and the interim efficacy evaluation according to other parameters~     routinely used in oncology.~   "
133955|NCT01301599|"~     This study is designed to investigate the comparison between alpha blocker monotherapy and~     5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic~     hyperplasia.~   "
133956|NCT01301586|"~     The purpose of this study is to evaluate a novel, combination product for the treatment of~     acne vulgaris in females~   "
133957|NCT01301573|"~     The purpose of this observational study is the long term follow-up of Parkinson's patients~     who participated in a clinical trial in which they received AAV-GAD gene transfer into the~     subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up~     to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and~     provide long term safety information.~   "
133958|NCT01301560|"~     The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non~     small cell lung cancer (NSCLC).~      Therefore, the investigators do a randomized study comparing overall survival between two~     groups with or without radiosurgery for asymptomatic oligo brain metastasis before~     palliative chemotherapy for NSCLC.~   "
134471|NCT01294774|"~     This study will assess the safety and efficacy of KRP203 in clinically active subacute~     cutaneous lupus erythematosus patients, who have demonstrated inadequate response to~     standard treatment, such as antimalarials.~   "
133959|NCT01301534|"~     Standard of care dictates that eligible patients should receive an abdominal aortic aneurysm~     (AAA) screening ultrasound. At present, different military primary care physicians utilize~     different methods at their discretion to ensure their patients get screened—telephone~     contact; mail-out reminders; referring patients for ultrasound directly from an office~     visit; as well as other methods—which we will refer to as usual care. The purpose of this~     study is to improve screening rates for AAA and determine what notification methods are best~     at improving screening rates.~   "
133960|NCT01301521|"~     The purpose of this study is to assess whether water-soluble cinnamon extract plus~     aggressive lifestyle intervention is effective in lowering blood glucose in pre-diabetic~     patients when compared to aggressive lifestyle therapy plus placebo.~   "
133961|NCT01301508|"~     The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and~     effective treatments for mild-to-moderate atopic dermatitis (AD).~   "
133962|NCT01301495|"~     In this study, a newly designed and FDA approved fully covered metal stents will be used to~     palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be~     assessed before and after treatment to confirm efficacy~   "
133963|NCT01301482|"~     The purpose of this study is to assess the effect of ear acupuncture alone in subjects with~     a contraindication to anti-inflammatory medications in the reduction of pain and hours lost~     from work in acute sore throat.~   "
133964|NCT01301469|"~     The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte~     infusion in comparison to HES 130/0.4 in a sodium chloride infusion.~   "
133965|NCT01301456|"~     The primary objective of this study is to evaluate the safety and tolerability of~     PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of~     metformin.~   "
133966|NCT01301443|"~     The purpose of this first in man study is to examine the safety of an experimental gene~     transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.~   "
133967|NCT01301430|"~     Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects~     suffering from glioblastoma multiforme.~   "
133968|NCT01301417|"~     The proposed study is a post marketing, observational, retrospective data collection~     intended to gather and record data on patients treated with the ColonRing™ device in routine~     clinical practice at a single center. The data will assist in further evaluating the~     performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.~      Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will~     be within the acceptable range reported in the literature for alternative treatment~     modalities.~   "
133969|NCT01301404|"~     PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR~     normally are female, obese and non-smoker which are risk factors for PONV. Recently, a~     multimodal approach, combining several means to minimize PONV, has found wide acceptance as~     a standard of care. In our hospital, most of the patients are supposed to fast after~     midnight The oral rehydration therapy reduce patients thirst and increase his satisfaction,~     but whether or not this method can reduce the incidence of PONV after low dose (0.2 mg)~     intrathecal morphine is not investigated yet. The aim of this study is to investigate the~     effect of preoperative oral rehydration therapy on the incidence of PONV.~   "
133970|NCT01301391|"~     The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with~     recurrent or metastatic, unresectable malignant thymoma previously treated with multiple~     lines of chemotherapy.~   "
133971|NCT01301378|"~     The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the~     Molteno 3 glaucoma drainage device during surgery~   "
133972|NCT01301365|"~     The aim of this study is to check whether patients with cystoscopic findings supporting the~     diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood~     pressure / pulse)than patients without cystoscopic findings.~   "
133973|NCT01301352|"~     The investigators are studying whether it is safe and effective to provide enteral nutrition~     to critically ill children via the nasogastric route, as opposed to the nasojejunal route,~     while they are receiving noninvasive positive pressure ventilation.~   "
133974|NCT01301339|"~     The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among~     those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and~     to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.~   "
133975|NCT01301326|"~     Best treatment option of retinal arterial macroaneurysm is still controversial. A recent~     publication has shown that subthreshold laser treatment can be beneficial in improving~     visual acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is~     to compare the effects of subthreshold laser treatment and threshold laser treatment in~     patients affected by symptomatic retinal arterial macroaneurysm.~   "
133976|NCT01301313|"~     To evaluate the efficacy and safety of levosimendan versus conventional intensified~     inotropic treatment, in critical children with severe acute heart failure which persists~     despite of having received conventional inotropic treatment.~   "
133977|NCT01301300|"~     Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™~     provides passive disinfection of valve top and threads without activating the luer access~     valve. This product promotes technique standardization and compliance in cleansing of the~     luer access valve prior to access. It acts as a physical barrier from touch and airborne~     contamination for up to 96 hours. This product has been endorsed and will be adopted for use~     at NorthShore University HealthSystem as a quality improvement initiative. This research~     study protocol is designed to confirm the anticipated benefit of this change in practice at~     NorthShore during the planned implementation and use.~      If the product performs as it has been designed to, the baseline rate of hub and~     subsequently intraluminal contamination will be diminished, thereby protecting patients with~     central lines from bloodstream infections due to contaminated hubs.~   "
134000|NCT01301001|"~     The Specific aims of this project are to (1) test the prediction that pain from tampon~     insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin~     compared to when treated with placebo. Secondary outcome measures include intercourse pain~     and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and~     to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more~     specific treatment options.~   "
133978|NCT01301287|"~     Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia,~     especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella~     through increasing glucose uptake in the liver and muscle, lowering serum free fatty acid~     levels, or activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic~     patients have not been studied. In order to clarify the hypoglycemic effects and mechanism~     of Chlorella in diabetic patients, the investigators conducted a 12-week randomized,~     double-blind, placebo-control trial on diabetic patients.~   "
133979|NCT01301274|"~     The primary objective of this study is to compare the mean serum sodium after 48 hours of~     therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill~     children requiring IV maintenance fluid administration.~   "
133980|NCT01301261|"~     Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular~     blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated~     to the reversal of the neuromuscular block. The aim of the study was to investigate the pure~     effects of sugammadex in the absence of the agonist.~   "
133981|NCT01301248|"~     To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the~     further addition of cetuximab experimental treatment~   "
133982|NCT01301235|"~     This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects~     with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal~     variable(s) to represent mitochondrial function.~   "
133983|NCT01301222|"~     This randomized controlled trial (RCT) aims at assessing the influence of octreotide on~     pancreatic fistula or complications following pancreatoduodenectomy in patients with soft~     pancreas. Previously reported trials have included all types of pancreatic resections and~     have include all types of pancreas and have shown no clearcut benefit of octreotide after~     pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for~     fistula following PD. This study's focus is on this select group of patients and aims to~     assess the role of octreotide in patients with soft pancreas.~   "
133984|NCT01301209|"~     Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of~     ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal~     disease.~   "
133985|NCT01301196|"~     Excessive periods of time spent sitting may be a risk factor for diabetes. Current~     lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car~     use, computers, and appealing screen-based home entertainment systems. Methods to help~     change such behaviours are now needed, particularly for those with a high risk of developing~     a chronic disease, such as diabetes. The investigators propose to decrease sedentary~     behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational~     intervention (attending a workshop and having prompts). If successful, this could have~     significant public health benefits given the widespread nature of sedentary behaviour.~   "
133986|NCT01301183|"~     Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of~     bone accrual, raising concerns regarding acquisition of peak bone mass, an important~     determinant of future bone health and fracture risk. Important factors contributing to low~     bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1).~     While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone~     formation. We have shown in a previous study that replacement of estrogen is effective in~     increasing bone density in teenage girls with AN; however, this increase in bone density~     remains lower than that seen in normal-weight controls over the same duration, and residual~     deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with~     estrogen replacement has not been studied in teenagers with AN.~      This study will examine the impact of administering recombinant human (rh) insulin like~     growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus~     administration of estrogen alone on bone metabolism in adolescent girls with anorexia~     nervosa (AN).~      One aim of this proposal is to investigate whether co-administration of insulin like growth~     factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will~     increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass~     will approach that seen in healthy adolescent girls. An additional aim is to determine~     whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu~     stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density~     to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach~     that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone~     microarchitecture will also be assessed.~   "
133987|NCT01301170|"~     The purpose of this study is to determine whether individuals with neck pain will respond~     favorably to a program of manual therapy, directed at the cervical and thoracic spine~     (including thrust manipulation), and exercise, in combination with dry needling, as compared~     to manual therapy, directed to the cervical and thoracic spine (including thrust~     manipulation), and an exercise program alone.~   "
133988|NCT01301157|"~     This study is to evaluate the efficacy and safety of M518101 and the dose relationship among~     two doses of M518101 and placebo in male and female plaque psoriasis patients.~   "
133989|NCT01301144|"~     Background:~        -  Tuberculosis is a disease of the lungs caused by the bacteria Mycobacterium~          tuberculosis (M. tuberculosis). The most popular and least expensive tool used to~          detect the presence of the tuberculosis bacteria is called sputum smears, which is a~          lab test used to look for bacteria in the sputum via a microscope. However, the test s~          results are not always accurate, and the test cannot determine if the bacteria will be~          resistant to standard tuberculosis treatments. The most sensitive test currently~          available is called sputum culture, in which a sputum sample is used to check for the~          growth of tuberculosis bacteria. However, this test takes at least a month to produce~          accurate results, and requires expensive equipment that is not available in many~          countries where M. tuberculosis is found.~        -  The urea breath test (UBT) has been used to detect infection with Helicobacter pylori,~          a bacteria associated with stomach ulcers, by testing individual breath samples.~          Researchers are interested in determining whether breath samples can also be used to~          detect the presence of M. tuberculosis in the lungs of subjects with tuberculosis, and~          to see if tuberculosis treatments are successful.~      Objectives:~      - To assess the sensitivity and specificity of urea breath testing in the diagnosis and~     treatment response of pulmonary tuberculosis.~      Eligibility:~        -  Individuals at least 18 years of age who either have been diagnosed with tuberculosis~          or are healthy volunteers with no past history of tuberculosis.~        -  The study will be conducted in Bamako, Mali.~      Design:~        -  This study will involve three groups: two pilot groups of individuals who have already~          been diagnosed with tuberculosis, and a primary study group of both healthy volunteers~          and individuals who have been diagnosed with tuberculosis.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood, sputum, stool, and urine samples.~        -  First pilot group (one visit):~        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.~        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT~          test, which involves a dose of Pranactin -Citric dissolved in water. Additional exhaled~          air samples will be collected at eight time points (10, 20, 45, 60, 90, 120, 180, and~          240 minutes after the dose).~        -  Second pilot group (one or two visits):~        -  Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.~        -  Participants will provide a baseline exhaled air sample, and then will receive the UBT~          test. Half of the participants will receive a dose of bismuth (Pepto-Bismol) prior to~          collection of air samples to see how this affects the results of the UBT test.~          Additional exhaled air samples will be collected at three time points specified by the~          study researchers.~        -  On the following day, participants will return for a second visit to provide three more~          exhaled air samples.~        -  Primary study group (five visits for participants with tuberculosis, two visits for~          healthy volunteers):~        -  All participants will have two visits, following the procedures given for the second~          pilot group. Half will receive a dose of bismuth prior to collection of air samples.~        -  Participants with tuberculosis will have three additional visits (days 6, 10, and 16~          following the first study visit) to provide additional sputum and exhaled air samples~          to monitor the progress of tuberculosis treatment.~   "
133990|NCT01301131|"~     Hospitalized patients with ventilator are randomized to receive fermented dairy product~     containing L. casei shirota or nothing. The main outcome is development of~     ventilator-associated pneumonia (VAP)~   "
134510|NCT01294267|"~     The purpose of this research study is to evaluate the safety and feasibility of the Impella~     2.5 Circulatory Support System for use during mapping and ablation of ventricular~     tachycardia in the setting of Ventricular dysfunction.~   "
133991|NCT01301118|"~     SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS~      INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and~     its control is a major challenge also for skin graft integration. Wound and soft tissue~     infection rates are higher than microbiological diagnosis rates.~      PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis~     of wounds in burn patients.~      METHODS: This project will be a transversal, prospective, analytical, controlled study in~     humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at~     Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected~     to characterize demographic and clinical aspects. Data analysis will be performed using~     Student's t-test and Friedman analysis of variance.~   "
133992|NCT01301105|"~     The project's objective is to explore the impact of Mindfulness-Based-Stress-Reduction~     (MBSR) on pain regulation, social stress, basic affective and attention functions, and on~     the brain, immune, and endocrine mechanisms that subserve these processes. Specifically, the~     investigators hypothesize that participants undergoing MBSR training will show decreased~     emotional distress on self-report measures, increased sustained attention on a behavioral~     task, decreased stress levels on a social stress test, decreased general psychosocial stress~     as indexed by diurnal salivary cortisol profile, changes in inflammatory response,~     modulation of cellular aging, and different neural patterns in response to thermal pain and~     aversive visual stimuli as indexed by functional Magnetic Resonance Imaging (fMRI).~      To test these hypotheses, the study will recruit 50 participants through the UW-Madison~     Integrative Medicine Program. All participants will be randomly assigned either to an 8-week~     MBSR program or to an 8-week training program in health-enhancement. At the conclusion of~     the study, participants will be invited to participate to the second class should they be~     interested. Participants will complete self-report questionnaires, behavioral tasks, fMRI~     scanning, cortisol sampling, and blood sampling before training begins, after the first~     program ends, and again four months after the first program ends and prior to the second~     program.~      If hypotheses are supported, the study may benefit participants by reducing their~     psychological distress, increasing their well-being, and helping them better manage pain and~     aversive stimuli. There are no other direct benefits to participants. Potential risks~     associated with fMRI include ferromagnetic collision, neurostimulation effects, and~     psychological discomfort. Potential risks to subjects include slight potential discomfort in~     providing saliva samples, discomfort of painful thermal stimulation, stress associated with~     the Trier Social Stress Test, some psychological discomfort from viewing disturbing~     photographs as part of the compassion fMRI study, and breach of confidentiality.~      Consent for the present study will entail both written and verbal descriptions of the~     protocol. Subjects will be informed that their participation is completely voluntary, and~     that they can withdraw at any time.~   "
133993|NCT01301092|"~     LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes~     mellitus. This study will compare the concentrations of LY2189265 using different methods of~     administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV -~     into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The~     purpose of this study is to look at how much of the drug gets into the blood stream and how~     long it takes the body to get rid of it when given by the methods above. The study is~     divided into three parts, Part A, B and C. Volunteers will only be able to participate in~     one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram~     (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg).~     Part B of the study will occur after Part A because the dose of IV drug will depend on the~     results of Part A. Part B of the study may not occur if the volunteers in Part A do not~     tolerate the drug. Participants in Part C will also be given drug twice by an SC injection~     and an IM injection, both doses will be 0.75 mg.~   "
133994|NCT01301079|"~     The aim of this study was to determine if the addition of ketamine reduces~     remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6~     and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).~   "
133995|NCT01301066|"~     A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.~   "
133996|NCT01301053|"~     The investigators believe that there remains a gap in implementing insulin infusions in~     critically ill patients to maximize the benefit and minimize adverse events like episodes of~     hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the~     investigators believe that it is safe to use in critically ill patients. Furthermore, the~     investigators believe that in combination with a protocol with low risk for hypoglycemia at~     baseline, that CGM can eliminate this risk fully.~      In this study the investigators will:~        1. Study the safety and feasibility of the continuous glucose monitor use in 20 critically~          ill patients for 7 days (the current maximum recommendation for sensor use). Safety~          data will include the rate of significant bleeding (hematoma) or infection (cellulitis)~          from sensor use. Feasibility data will evaluate the amount of missing glucose data over~          the 7-day sensor life.~        2. Randomize patients treated with the current UVA intensive care insulin protocol for~          insulin management to the addition of brakes that reduce insulin administration based~          on continuous glucose monitoring data between hourly reference glucose data to prevent~          episodes of hypoglycemia (blood glucose <70 mg/dl) and severe hypoglycemia (blood~          glucose <50 mg/dl). This will serve as pilot data to power a larger study in the~          future.~   "
133997|NCT01301040|"~     The primary objective is to evaluate the difference in cardiac strain rate evolution in~     elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy~     compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.~      This study also will compare the serum biomarkers profile during and after the (neo)~     adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than~     standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT,~     assess whether brain PET-CT allows detecting regional functional impairment in patients~     receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both~     treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT~     in both treatment arms, evaluate psychological state and burden of primary caregivers before~     and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to~     detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both~     treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate~     the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the~     Framingham risk score for Hard Coronary Heart Disease (10-year risk).~   "
133998|NCT01301027|"~     This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight~     or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether~     pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and~     whether these changes result in reduction of inflammation, insulin resistance and oxidative~     stress and increase in muscle mass.~      In addition, this study will also examine the associations of adiposity with adipokines and~     the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes~     in uremic milieu.~   "
134001|NCT01300988|"~     The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like~     aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle~     of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those~     observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential~     antiviral effect this could alter disease progression in patients with HIV infection.~      The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral~     activity in HIV infected individuals.~      This is randomized, placebo controlled, double blind study to determine the safety and~     antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks~     of aprepitant monotherapy.~      18 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell~     counts ≥ 350 cells/mm3. Subjects will be randomized 1:1 to receive 375 mg of aprepitant~     (Emend®) or placebo.~   "
134002|NCT01300975|"~     Intralesional injection of antimony has been used for L major from Iran with a modest cure~     rate [56%: Asilian 2004]. However, this therapeutic approach has been used for L~     braziliensis from Brazil, with an attractive cure rate after 3 months of 80% [Oliveira-Neto~     1997]. Because intralesional Sb injections is the local therapy with the best reported cure~     rate for South American L braziliensis disease, the species that causes disease in Bolivia,~     this pilot study of local therapy for bolivian L braziliensis disease will evaluate~     intralesional Sb therapy.~   "
134003|NCT01300962|"~     This phase I study has been designed to establish the safety, tolerability and maximum~     tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer:~     dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and~     trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235~     when combined with capecitabine (Arm B).~   "
134004|NCT01300949|"~     The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast~     sensitivity. The test is performed on any standard computer with internet access. Patients~     will be tested with SPARCS and with the standard Pelli-Robson contrast test.~   "
134005|NCT01300936|"~     The purpose of this study is to measure abdominal wall strength both preoperatively and~     postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators~     hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate~     the rectus musculature to the midline. Abdominal wall strength measurements would be~     obtained utilizing various abdominal strength testing.~   "
134006|NCT01300923|"~     Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS~     is inherited from the carrier parent, most often the mothers. FXS is associated with severe~     interfering behavioral symptoms which include anxiety related symptoms, attention deficit~     hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also~     meet criteria for autistic disorder. The hypothesis of this study is that treatment with~     acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social~     deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate~     the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to~     assess the potential psychophysiological differences between FXS and autism spectrum~     disorders.~   "
134007|NCT01300910|"~     This is a randomized control trial of 400 adult male circumcision procedures with a one to~     one ratio between Shang Ring and the in-country standard surgical technique (forceps guided~     in Kenya and dorsal slit in Zambia).~   "
134008|NCT01300897|"~     Biofeedback therapy improves bowel symptoms and anorectal function in patients with~     dyssynergic defecation, however its mechanism of action is not known. The investigators~     hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering~     cortical processing of information and improving cortically mediated neuromuscular function~     of the gut. However, in order to better understand these mechanisms in patients, the~     investigators need to examine and establish normative data and compare findings with healthy~     subjects. The investigators specific aims are to examine and evaluate the following 40~     normal subjects; (1) To evaluate the afferent cortical evoked potentials in response to the~     electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts~     (efferent) by recording the anal and rectal electromyographic responses following~     noninvasive lumbosacral and transcranial magnetic stimulation.~   "
134009|NCT01300884|"~     Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately~     characterizes anorectal anatomy and function in healthy humans; HDM provides comparable~     information regarding the structure and function of the anorectal region, to that obtained~     from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal~     incontinence or constipation.~      Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with~     constipation will be recruited. Because anorectal disorders are more common in women, the~     investigators will recruit approximately 8 men and 12 women in each group. Each subject will~     undergo anorectal manometry, anal ultrasound and high definition manometry.~      Data Analysis: Spearman correlational analysis will be performed to compare the parameters~     listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying~     anatomic sphincter defects will be assessed.~   "
134010|NCT01300871|"~     This is a study to determine the prevalence and severity of alopecia (hair loss) experienced~     by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen,~     Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).~   "
134011|NCT01300858|"~     Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within~     the body's cells. When genes are damaged, the body may be unable to produce a group of~     proteins, called cytokines, used by the immune system to fight cancer and some infections.~     The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine~     interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the~     body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to~     attempt to enhance the body's natural ability to recognize and fight cancer cells.~   "
134012|NCT01300845|"~     In France, the most used humidifying system during oxygen therapy is a non heated device~     with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of~     benefits of non-heated humidification compared to no humidification, as regards to the~     comfort of the patient receiving oxygen therapy.~   "
134013|NCT01300832|"~     The study's hypothesis is that there are some patients who come for surgery who have~     asymptomatic clots in their lower extremities upon their arrival to the hospital for their~     surgical admission. We will be performing duplex studies of the subjects' legs before their~     surgery to determine how often clots are present. We will also perform duplex scans of the~     legs after the subjects' surgeries to determine what factors (surgical, anesthetic,~     co-morbidities)are correlated with the development of DVTs.~   "
134014|NCT01300819|"~     The primary objective of this study was to demonstrate that Rotigotine improves non-motor~     symptoms compared to Placebo in subjects with Parkinson's Disease.~   "
134015|NCT01300806|"~     The goal of this research is to assess the impact of the screening, brief intervention, and~     referral to treatment (SBIRT) intervention strategy for harmful substance use among~     HIV-positive people.~   "
134016|NCT01300793|"~     Primary objective of the study is to determine the maximum tolerated dose (MTD) of~     bortezomib (Velcade) in combination with rituximab, ifosfamide, carboplatin and etoposide~     for adult patients with relapsed or refractory aggressive B-cell lymphoma. The secondary~     objectives are to assess the tolerability and safety, the response rate, rate of autologous~     stem cell transplant and CD34+ progenitor cell collection and engraftment after treatment~     with this regimen.~   "
134017|NCT01300780|"~     Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme~     specific for pain may be more effective in preventing the tooth sensitivity caused by the~     inflammatory response produced by in-office bleaching. To the extent of the authors´~     knowledge, no study has so far addressed the use of a selective anti-inflammatory drug~     specific for pain enzyme on tooth sensitivity, being this the aim of the present~     investigation.~   "
134018|NCT01300767|"~     The purpose of this study is to compare the performance of two commercially marketed contact~     lenses when worn for up to 4 weeks in a daily wear modality.~   "
134019|NCT01300754|"~     Objective: To examine the potential of dextrose injection versus lidocaine injection versus~     supervised usual care to change pain/function/activity levels in adolescent athletes with~     Osgood-Schlatter Disease (OSD).~   "
134020|NCT01300741|"~     The purpose of this study is to compare the performance of two commercially marketed contact~     lenses when worn for up to one month in a daily wear modality.~   "
134021|NCT01300728|"~     Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk~     of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous~     immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer~     disease.~      This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI~     over 24 months after the first infusion. This study will also document conversion from MCI~     to Alzheimer's Disease.~   "
134022|NCT01300715|"~     In spite that variable techniques for lumbar MBRF exists, the tunnel vision technique is~     widely recommended for exact radiofrequency needle placement. However, this method uses the~     concept of a steep caudocephalad axial tilt of the fluoroscopy beam, which result in unusual~     appearance of vertebral structures and a long distance from skin to the target site. In our~     institution, therefore, the investigators have used a modified method that is easy and safe~     to place RF needle parallel to the lumbar medial branch in oblique fluoroscopic view.~      Accordingly, our objectives were to evaluate our modified technique for lumbar MBRF,~     comparing with the tunnel vision technique, and additionally to assess complications with~     respect to these two techniques.~   "
134023|NCT01300702|"~     Investigation of thermal thresholds and sensory mapping to thermal stimuli~   "
134024|NCT01300689|"~     This is a observational study aims to assess anal and genital human papillomavirus (HPV)~     infection status among men who have sex with men (MSM) in China, and their knowledge and~     attitude about HPV vaccine.~   "
134025|NCT01300676|"~     Despite evidence supporting the benefits of hormone replacement therapy (HRT), only 15% of~     postmenopausal women currently use HRT (1). The leading reasons why women refuse or~     discontinue HRT are fear of malignancy, side effects such as vaginal bleeding, weight gain,~     depressed mood, and breast tenderness, and social reasons such as regarding menopause as a~     natural transition, not as a disease that requires treatment. Millions of women expressed~     their concern on the safety of hormone replacement therapy since the data from the Women's~     Health Initiative (WHI) study was released, which reported an increased risk of~     cardiovascular disease, breast cancer, stroke and thromboembolic disease with conjugated~     equine estrogen plus medroxyprogesterone acetate compared with placebo (2). The study has~     also demonstrated that quality of life (3) and cognition (4) were no better in the HRT group~     than the placebo group. In view of these problems, women are increasingly turning to~     alternative therapies in an effort to manage their menopausal symptoms (1).~      Menopause is associated with decreasing sex steroid levels. The effect of menopause on~     circulating androgen levels has been studied by several investigators with variable~     findings. The levels of testosterone and androstenedione appear to show a small but~     significant decrease just before or within the first 2 years after menopause, with a~     decrease in testosterone amounting to approximately 15% (5,6). Unlike the abrupt decrease in~     estradiol levels associated with menopause, circulating testosterone, DHEA, and DHEAS levels~     decrease more gradually, beginning in the years before menopause and continuing thereafter~     (6,7). As a consequence, some women may experience symptoms of androgen decrease in the~     period before cessation of menses. By giving Tualang Honey to these postmenopausal women, it~     is postulated that the symptoms of androgen deficiency or menopausal symptoms should be~     reduced.~      The investigators have also reported that tualang honey given to ovariectomised rats, an~     animal model for postmenopausal states for two weeks significantly increased the free~     testosterone and progesterone plasma levels, but no significant effect was seen in the~     beta-estradiol level. There were significant increased in the thickness of vaginal~     epithelium and vaginal epithelial-muscular layers. Proliferation of the squamous epithelium~     with vacuolation of some of the squamous cells were noted in the honey treated animals~     implying that there were increased in mucopolysacharide content. Uterine weight, endometrial~     and circular muscle thickness were significantly increased in honey treated animal with~     cystic changes noted over the glands (8).~      To date, there are no clinical studies looking at the effects of Tualang Honey on~     perimenopausal women. In view of the initial evidence that it is a phytoestrogen from animal~     studies and has androgenic properties as well, it should have a beneficial effect to these~     women in terms of improvement in their menopausal symptoms, changes in their endogenous~     hormonal profile and increase in bone mineral density.~   "
134026|NCT01300663|"~     Post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia~     and vulvar cancer) are still high and an instrument assessing patients self-reported~     post-vulval surgery symptom experiences is missing. The study aims to develop and validate a~     postoperative instrument to assess symptom experiences in women with vulvar neoplasms. In~     this mixed-method project 20 patients were interviewed, a WOMAN-PRO instrument was developed~     and content validity was tested by 6 experts and 10 patients. The instrument's psychometric~     properties and the prevalence of symptoms will be examined in a cross-sectional study in the~     University Hospitals Munich, Freiburg, Berlin, Düsseldorf, Zurich, Basel, Berne, and the~     Cantonal Hospital St. Gallen (N=150). The goal of this project is that symptom assessment~     becomes a standard component of clinical practice (to promote the early detection and~     treatment of symptoms) and research.~   "
134027|NCT01300650|"~     This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1~     blockade on exercise capacity in patients with heart failure. Subjects will undergo~     cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra~     (recombinant human Interleukin-1 receptor antagonist).~   "
134028|NCT01300637|"~     Background: Several studies have suggested that clozapine has the greatest propensity of all~     available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it~     is necessary to conduct some interventions to prevent or treat metabolic dysregulation~     induced by clozapine.~      Metformin has been reported to achieve weight loss in several groups of patients~     characterized by insulin resistance. Several studies evaluated the effects of metformin on~     antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term~     metformin use had more robust effect on metabolic dysregulation and body weight in~     non-psychiatric field.~      Goals: The study goals are two-fold. The first goal is to estimate the prevalence of~     metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second~     goal is to assess the reversal effect of metformin on metabolic disturbance among~     clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial.~     The investigators will use metformin 1500 mg/d or placebo in the second phase trial.~      Methods: This study will be divided into two phases. The first phase is to estimate the~     prevalence of metabolic disturbances among clozapine-treated patients. The second will be a~     randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM~     clozapine-treated patients.~      The clozapine dosage was maintained unchanged during the study period. The eligible patients~     will be randomly assigned to either metformin or identical placebo pills. Metformin will be~     titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body~     weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein~     cholesterol (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after~     the start of metformin.~      In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in~     the first phase and 75 fulfill the second phase criteria. The investigators estimate 60~     patients complete the second phase intervention (staying in second phase at least 4 weeks).~      From this study, the investigators would like to know the prevalence of metabolic~     dysregulation among clozapine-treated schizophrenic patients and to know the effect of~     metformin on metabolic profile among non-DM clozapine treated patients.~   "
134029|NCT01300624|"~     The purpose of this study is to evaluate the effect of Verb Network Strengthening Treatment~     (VNeST) on the ability to produce sentences and connected speech in persons with aphasia.~   "
134030|NCT01300611|"~     The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet~     counts in adult patients who have undergone a double cord blood transplant. The study will~     also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the~     mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which~     helps patients fight infections. For patients undergoing CBT, both neutrophil and platelet~     normalization and immune reconstitution can be delayed. TXA127 has shown to be well~     tolerated by patients and appears to induce a rapid production of neutrophils and platelets~     in the bloodstream as well as increase the immune system components. It has also been shown~     to reduce the severity of chemotherapy-induced mucositis.~   "
134031|NCT01300598|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     degenerative arthritis.~   "
134032|NCT01300585|"~     The purpose of this study is to test a new method of defining patterns of how breast glands~     are or are not attached to the overlying skin. All patients will have markers placed on both~     breasts and will undergo an MRI. MRI results will be examined to identify the pattern of~     breast gland attachment to the overlying skin. This will help identify patients which may~     benefit from areolar sparing and/or nipple sparing technique and which patients should be~     treated by standard mastectomy.~   "
134033|NCT01300572|"~     This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90~     anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by~     donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute~     lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back~     or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body~     irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant~     helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system~     from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8,~     can find cancer cells and carry cancer-killing substances to them without harming normal~     cells. When the healthy stem cells from a donor are infused into the patient they may help~     the patient's bone marrow make stem cells, red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with~     cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.~   "
134034|NCT01300559|"~     The overall objective of the investigators research is to test the clinical efficacy of the~     TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing~     hemoglobin loss intraoperatively. This is a prospective, randomized investigation that will~     be performed at Duke University Medical Center (DUMC). The overall goal of this study is to~     evaluate the efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss~     preoperatively, intraoperatively and postoperatively for patients undergoing multilevel~     elective spinal surgery. Not greater than eighty patients scheduled for elective,~     multi-level decompression and fusion spinal surgery with Dr. William Richardson will be~     randomized into two groups. Unipolar electrocautery will be used for intraoperative~     coagulation in one group and the Tissuelink device plus Unipolar electrocautery in the~     other. These are frequently performed cases with significant blood loss but otherwise low~     morbidity/mortality that would benefit from more effective intraoperative coagulation.~   "
134035|NCT01300546|"~     This study is being conducted to evaluate the hypothesis that use of pharmacological and~     non-pharmacological interventions may allow subjects at high risk for chronic migraine to~     avoid or reverse the transformation of episodic migraine to chronic migraine.~   "
134036|NCT01300533|"~     The goal of this Phase 1 clinical research study is to find the highest safe dose of~     BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer.~   "
134037|NCT01300520|"~     The current method of incision localization in many surgical procedures requires a doctor to~     reference a medical image, such as an X-ray, to judge where on the body an incision should~     be made. However, the precise information of the scan is not shown on the patient's skin.~     Surgeons commonly use palpation to locate the point of incision. They may feel for the area~     directly or find landmarks under the skin and estimate the location from there. The~     following factors further complicate palpation: overweight patients, foreign bodies that are~     difficult to feel for under the skin, fractures with little displacement, or locations under~     dense muscles. These difficulties are compounded for new surgeons, since palpation is a~     skill derived through experience.~      In many circumstances the surgeon only needs to know where to insert the tool or place the~     incision - they do not necessarily need to know the depth of the area of interest. If~     palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the~     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer~     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and~     the patient to radiation. Many fluoroscopic images may be required in a single procedure.~      By identifying the efficacy of this new medical device, Target Tape, there is the~     potential outcome of making smaller incisions, faster localization, a reduction in~     fluoroscopy use and a reduced chance in surgical error and the associated costs.~      Target Tape is a non invasive device that is in a grid or ruler format that is placed~     against the subject's skin. The grid/ruler pattern will then appear on the medical imaging~     scan. Standard surgical skin ink is then used to place these markings in a defined pattern~     on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical~     practitioner can correlate these skin markings to the medical scan image to make their~     incisions in more accurate locations.~   "
134038|NCT01300507|"~     The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data~     regarding patients presenting with stent thrombosis in a dedicated database. There will be~     extensive clinical and procedural characterization, furthermore blood platelet function~     testing, intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be~     performed.~   "
134039|NCT01300494|"~     An optimal angiographic viewing angle is critical for correct diagnosis and intervention in~     coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study~     aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will~     improve the selection of the best viewing angle.~   "
134040|NCT01300468|"~     The purpose of this open-label, multi center, Phase I study was to determine the safety~     profile of the oral compound PHA-848125AC administered according to two different schedules~     of administrations to advanced/metastatic solid tumor patients. Objectives of the study were~     to determine the maximum tolerated dose and the dose that can be recommended for Phase II~     investigations.~   "
134077|NCT01299974|"~     The study seeks to implement and test a novel approach to teach pediatric residents about~     patient and family-centered care (PFCC). The approach calls for a supervised meeting between~     a family member of a previously hospitalized child and a resident in the context of a~     pediatric residency rotation.~   "
134042|NCT01300442|"~     Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve~     respiratory muscle strength in patients with respiratory muscles weakness. However, this~     physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease~     (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the~     session of TEDS besides its effect in respiratory muscle strength and in spirometric~     variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients~     are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt~     System - VivoMetric), respiratory muscle strength and spirometry will be made. The~     hypothesis is that the TEDS can helps COPD patients that shows respiratory muscle weakness.~   "
134043|NCT01300429|"~     The purpose of this study is to try to learn more about how small molecule kinase inhibitor~     medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been~     shown to shrink tumors in some patients with lung cancer. While the investigators know how~     this drug works to stop the growth of tumors that depend on change in the gene named ALK~     (also called EML4-ALK), the investigators do not know why the drug stops working. The~     investigators would like to examine the tumor to help us better understand why crizotinib~     has stopped working as well as it once did. The tumor will be examined with multiple tests~     to look for the reason that crizotinib stopped working.~   "
134044|NCT01300416|"~     This study will access the GI complaints on patients reported outcomes and to determine the~     improvement in quality of life in patients.~   "
134045|NCT01300403|"~     This study aimed to evaluate the acute physiological effects of expiration with the glottis~     open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in~     patients with bronchiectasis and, secondarily, to study the effect of these techniques in~     sputum production.~   "
134046|NCT01300390|"~     The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin~     levels are accurate predictors of underlying cardiovascular disease in patients with~     end-stage liver disease, in whom standard tools for the diagnosis of and screening for~     cardiovascular disease are of limited utility.~   "
134047|NCT01300377|"~     The goal of the proposed study is to investigate the relationship between two standard~     treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain,~     and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo~     arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent~     clinical and/or demographic factors. No control group is necessary.~   "
134048|NCT01300364|"~     Main objective: To assess the efficacy of two antidepressants of different pharmacological~     families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine~     (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine~     for the treatment of negative symptoms of schizophrenia.~      Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct~     treatments to risperidone and olanzapine for the treatment of cognitive symptoms of~     schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments~     for the treatment of negative and cognitive symptoms of schizophrenia.~      Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six~     months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV~     criteria) and significant negative symptoms, will be recruited in the 9 participating~     centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global,~     GAF,LSP, Hamilton scale, BACS)~   "
134049|NCT01300351|"~     The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant~     with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor~     positive advanced breast cancer who have failed a prior endocrine treatment.~   "
134050|NCT01300338|"~     Does home telemonitoring increase the number of diabetes patients at goal blood pressure in~     a primary care practice?~   "
134051|NCT01300325|"~     Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization~     in children younger than 2 years. In the United States it has been shown that the burden of~     the disease is considerable, having an annual cost of more than $ 500 million and being~     responsible for the 17% of all infant hospitalizations . Aim of the present study was to~     verify the effects of nebulized 3% saline solution in comparison to normal saline in~     addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all~     patients presented a disease as much as severe to require hospitalization.The main study~     endpoints were the length of stay in hospital and the clinical response.~   "
134052|NCT01300312|"~     The purpose of this study is to investigate the effects of a fixed dose combination of~     diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in~     patients with low back pain.~   "
134053|NCT01300299|"~     This trial will test the feasibility of adjuvant chemotherapy after stereotactic body~     radiation therapy for early stage non-small cell lung cancer (NSCLC).~   "
134054|NCT01300286|"~     The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL~     Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving~     hemostasis thereby reducing overall blood product transfusion after separation from~     cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size~     this is a pilot study and in effect will determine the fibrinogen level response to~     fibrinogen concentrate administered during aortic reconstructive surgery. It will be~     underpowered to detect reduction in bleeding but comparison to historical controls will be~     included as a secondary outcome.~   "
134055|NCT01300273|"~     The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine~     podocyte loss and lower the angiotensinogen level in the urine.~   "
134056|NCT01300260|"~     The purpose of this study is to measure the effect of LY2189265 to increase insulin levels~     in response to glucose intake.~   "
134076|NCT01299987|"~     This prospective, multicentric single arm phase II study is based on the protocol of the~     international TARGIT-A study. The purpose is to investigate the efficacy of a single~     intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1,~     cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In~     presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic~     treatment according to international guidelines.~   "
134086|NCT01299857|"~     The purpose of this study is to study the midterm clinical evaluation, biological parameters~     and immune reconstitution after Rituximab treatment for Pemphigus.~   "
134057|NCT01300247|"~     This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the~     safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with~     chemotherapy (bendamustine or fludarabine + cyclophosphamide [FC] regimens) in participants~     with previously untreated cluster of differentiation 20 (CD20)-positive B-CLL. Participants~     will be enrolled to receive a maximum of 6 cycles of obinutuzumab (1000 milligrams [mg]~     intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus~     bendamustine (90 milligrams per meter square [mg/m^2] IV, on Days 2 and 3 of Cycle 1 and~     Days 1 and 2 of Cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of obinutuzumab~     (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus FC~     (fludarabine 25 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6;~     cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2~     - 6) on 28 day cycles.~   "
134058|NCT01300234|"~     This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate~     the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB.~     This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in~     treating Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and~     HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240~     weeks) for TDF 300 mg administered once daily.~   "
134059|NCT01300221|"~     The propose of this study is to generate normative data of the tree-dimensional~     echocardiographic(3-DE) measurements for cardiac structure and function in a large cohort of~     normal infants, children,and adolescents. The investigators also sought to investigate the~     utility of 3-DE in evaluating infants, children and adolescents with congenital and acquired~     heart diseases.~   "
134060|NCT01300208|"~     This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety,~     tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.~   "
134061|NCT01300195|"~     Prospective cohort study of factors predisposing to persistent post surgical pain after~     video-assisted thoracic surgery~   "
134062|NCT01300182|"~     To investigate the effect of early WBVT on neuromuscular control after ACLR.~   "
134063|NCT01300169|"~     This is a randomized controlled trial comparing the use of new clinical intervention (the~     Collaborative Assessment and Management of Suicidality--CAMS) versus enhanced care as~     usual for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart~     GA.~   "
134064|NCT01300156|"~     The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy~     with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for~     patients with refractory or relapsed Hodgkin's lymphoma (HL).~   "
134065|NCT01300143|"~     Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes~     whose total tumor mass can technically be irradiated, non-resectable, and not a candidate~     for percutaneous therapy with recommended treatment via hyperselective transarterial~     chemoembolisation (TACE).~   "
134066|NCT01300130|"~     The investigators examined the effect of different levels of docosahexaenoic aicd (a long~     chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and~     erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm~     infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid~     into their corresponding long chain polyunsaturated fatty acids was studied.~      Preterm infants were randomized in a double-blind fashion to one of three formulas~     containing different amounts of docosahexaenoic acid during the first two weeks of postnatal~     life. A control group received human milk. Blood samples were collected at study entry and~     14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were~     applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56~     weeks visually evoked potentials were recorded.~   "
134067|NCT01300117|"~     The purpose of this study is to determine whether extracorporeal circulation during cardiac~     surgery has an influence on ADAMTS13-Activity.~   "
134068|NCT01300104|"~     PURPOSE:~      To evaluate the feasibility of a future Nordic intervention trial, including vigorous~     activity and a high intake of whole grain rye, among prostate cancer patients on active~     surveillance.~      Additionally, to investigate effects of the lifestyle intervention according to cancer~     progression, the metabolic profile, inflammation and quality of life among prostate cancer~     patients on active surveillance.~   "
134069|NCT01300091|"~     Consumption of medical care and outcome of shoulder pain and disability in primary care.~   "
134070|NCT01300078|"~     This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy,~     postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses~     of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United~     States.~   "
134071|NCT01300052|"~     The purpose of this study is to determine whether AN2728 topical ointment is a safe and~     effective treatment for mild-to-moderate plaque-type psoriasis.~   "
134072|NCT01300039|"~     The investigators are finding out if giving antibiotics for Helicobacter pylori will~     eliminate colonization of the colon by Oxalobacter formigenes.~   "
134073|NCT01300026|"~     This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with~     relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose~     exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid~     malignancies and uses a practical continuous reassessment model [CRM] to guide dose~     escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with~     CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical~     activity of AMG 319 in this patient population.~   "
134074|NCT01300013|"~     The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV)~     omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular~     systolic dysfunction hospitalized for acute heart failure. This is a multicenter,~     randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially~     in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are~     randomized 1:1 to omecamtiv mecarbil or placebo.~   "
134075|NCT01300000|"~     The primary objective of the study is to compare the growth of infants fed standard infant~     formula with infants fed a reduced calorie and protein formula.~   "
134078|NCT01299961|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing~     pain and swelling) associated with significant health problems. It is a difficult disease to~     manage as the disease is often unpredictable. RA causes inflammation (swelling) of the~     joints that can cause joint damage, deformity, and progressive disability and impairment. It~     is estimated that 1% of the world's population suffers from this disease.~      The purpose of this research study is to determine if a change in inflammation seen on the~     ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to~     treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.~   "
134079|NCT01299948|"~     There has been reports that low dose prednisolone stabilizes CD4-counts in HIV infected~     individuals. However, until now, there are no prospective randomized studies on the use of~     corticosteroids in latent HIV disease. Furthermore, low dose prednisolone (5 mg/d) is not~     sufficient tested for the risks and benefit for HIV patients especially for those living in~     poor settings with a higher risk of infections. This study will assess the benefit and the~     safety profile for low dose prednisolone therapy for patients in a region with limited~     resources and high prevalence of infections.~   "
134080|NCT01299935|"~     This randomized controlled clinical trial tests the hypothesis that a selected stress~     reduction approach, the Transcendental Meditation program will reduce all-cause mortality,~     myocardial infarction and stroke in African American patients with coronary heart disease.~     Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure~     and psychosocial stress.~   "
134081|NCT01299922|"~     The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of~     lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in~     both the induction and maintenance with similar results at least to those offered by the~     classic pattern and possibly with fewer side effects, especially for long term. The~     association of prednison and mycophenolate has created large expectations to that effect,~     and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.~      Despite the significant advances that have led to these treatments, the likelihood of~     complete remission after six months remains, according to the series of 8-13% and partial~     remission do not exceed 60% in papers published. In the last year, two articles have been~     published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in~     poor prognosis of lupus nephritis with hopefully better results than those obtained~     previously. In this study we try to compare the effectiveness of triple therapy, the therapy~     is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type~     III-IV-V~   "
134082|NCT01299909|"~     The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The~     study design includes two randomized arms to compare matched intensive interventions and a~     third non-randomized option for participants who prefer not to enter an intensive~     intervention. It is expected that roughly 50% (120) will choose to be in the randomized~     intensive interventions and 50% (120) will choose to be in the non-intensive intervention.~     Participants who choose to be in an intensive intervention will be randomized to either~     Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers~     (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes~     over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in~     mindfulness whereas ITS provides training in quit smoking strategies and access to the~     Freedom From Smoking Online Premium Program. Participants who choose to be in a~     non-intensive intervention (estimated from prior recruitment data at n=120) will receive a~     phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine~     patches.~   "
134083|NCT01299896|"~     The purpose of this research study is to examine the effectiveness of an intervention~     designed to reduce smoking in low income veterans within a regional United States Veterans~     Administration(VA) health care system. A proactive, personalized, coordinated system of care~     Connect to Quit (CTQ) is rooted in the Chronic Care Model. CTQ treats smoking as a chronic~     condition, like hypertension or diabetes, that requires long term treatment with appropriate~     combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context~     of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.~   "
134084|NCT01299883|"~     The investigators will evaluate the effects of an integrated risk counseling program on~     behavioral and psychological outcomes in African American men and women in a randomized~     trial that is implemented and evaluated collaboratively through the West Philadelphia~     Consortium to Address Disparities. The specific aims of this research are as follows:~        1. To evaluate the effects of integrated versus disease specific counseling on risk~          exposure behaviors. The investigators predict that compared to individuals who receive~          disease specific counseling, those who receive integrated counseling will report~          greater intake of fruits and vegetables and increased rates of physical activity.~        2. To evaluate effects of integrated versus disease specific counseling on psychological~          outcomes. The investigators predict that compared to individuals who receive disease~          specific counseling, those who receive integrated counseling will report greater risk~          comprehension related to cancer and cardiovascular disease and will be more motivated~          to make behavioral changes.~        3. To identify the mechanisms through which integrated risk counseling leads to behavioral~          change. The investigators predict that changes in risk exposure behaviors (e.g., diet~          and physical activity) will be mediated by increased risk comprehension and~          self-efficacy for diet and physical activity.~   "
134085|NCT01299870|"~     Epilepsy is a disorder in the brain. The brain is full of nerve cells. Nerve cells have~     normal electrical activity to control the many functions of the body. Sometimes nerve cells~     do not function normally due to many different reasons such as disease, an injury or because~     the brain didn't develop normally at birth. When nerve cells do not function normally the~     electrical activity that controls things like muscles and body movement can get mixed up and~     cause seizures. When a seizure occurs, sometimes a person loses control of body movement,~     and/or bodily functions. When a seizure occurs, a person may become unconscious, and/or~     senses may be affected. Seizures can occur at any time, without warning, and can lead to~     many health problems.~      Catamenial epilepsy is specific form of epilepsy in women. It is closely related to the~     menstrual cycle. In this form of epilepsy seizures increase around the menstrual period.~      By doing this study, researchers hope to learn whether Keishibukuryogan add-on therapy with~     antiepileptic drugs is safe for women with epilepsy.~   "
134087|NCT01299844|"~     The objectives of this study are:~        -  To develop a comprehensive culturally tailored model of diabetes management that~          integrates the work of community-based peer counselors and clinical specialists into a~          multi-disciplinary health care team serving the Latino community.~        -  To implement an intervention that provides education and support to Latino adults~          diagnosed with Type 2 diabetes in both clinical and home settings.~        -  To evaluate this intervention for its impact on program adherence, and improved~          outcomes sustained over time as reflected by metabolic, clinical, cognitive and~          behavioral measures.~   "
134088|NCT01299831|"~     The purpose of this study is to investigate signaling pathways in fat and muscle, as well as~     turnover of protein, sugar and fat after stimulation with growth hormone and during fasting~     in lean and obese subjects. This will help clarify differences in the human metabolism~     between lean and obese subject and provide us with a better understanding of the molecular~     mechanisms regulating the basic metabolism during prolonged fasting.~   "
134089|NCT01299818|"~     -  Pain is one of the most common concerns for which patients seek medical attention.~        -  Pain is usually understood as symptom that reflects peripheral organic damage. Many~          patients experience pain, often chronically, independently of any underlying cause such~          as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain~          syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In~          all those functional syndromes, accumulated evidence supports involvement of central~          pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous~          system, and are now referred as central pain conditions.~        -  Other patients suffers from chronic pain caused by damage or inflammation in peripheral~          tissues, but also experienced more diffuse pain, not directly explained by peripheral~          damage, that further aggravates pain and function. This is illustrated by the high~          prevalence of fibromyalgia observed in patients with rheumatoid arthritis,~          osteoarthritis or ankylosing spondylitis for example.~      These pain conditions are now understood as combinations of peripheral, neuropathic and~     central pain.~      The investigators aimed to focus in this study in patients that are candidates to spinal~     surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise~     from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral~     pain-, and may also reflects alteration in central pain processes.~      In these patients, spine surgery is usually performed to improve quality of life, decrease~     pain and avoid neurological deficits. Evaluation of surgical outcome includes objective~     measures such as neurological findings and radiographic evaluation, and subjective measures~     including patient self-assessments for pain and quality of life and psychological changes.~      The aim of this study is to evaluate patients who undergo spinal surgery for presence of~     central pain and central sensitization symptoms and evaluate their influence on these~     surgical outcomes~   "
134090|NCT01299805|"~     The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the~     body), the pharmacokinetics (the body's handling of the drug), and the safety and~     tolerability of vortioxetine, once daily (QD) in healthy men.~   "
134091|NCT01299792|"~     Video-urodynamic investigations are regarded as the current standard diagnostics for~     neurogenic bladder dysfunction in patients with spinal cord injury. This examination is~     exact, but time consuming, costly and associated with the risk of urinary tract infection.~      In patients with lower urinary tract symptoms due to benign prostate hyperplasia,~     sonographic measurement of bladder wall thickness has been demonstrated to be able to~     replace urodynamic testing for the diagnosis of infravesical obstruction.~      Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder~     dysfunction due to spinal cord injury is closely related to the known risk factors for upper~     urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group~     of patients and can therefore replace urodynamic examination in selected cases.~   "
134092|NCT01299779|"~     Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG~     3350 + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium~     ascorbate and ascorbic acid (PEG-ELS).~      Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with~     PEG-ELS.~   "
134093|NCT01299766|"~     The goal of this study is to determine whether increasing participation in cognitive,~     physical, and/or social activities prevents cognitive decline in older African Americans~     (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for~     Alzheimer's Disease (AD); we propose that increasing participation in activities will~     prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test~     this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years~     and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that~     increases participation in daily activities) or Supportive Therapy (ST) (a person-centered~     psychotherapy that involves active listening and offering support focusing on participants'~     problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in~     cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and~     better quality of life than ST-treated subjects at 24 months.~   "
134094|NCT01299753|"~     Severe burn is associated with a wide array of stress, metabolic, and physiologic processes~     in an attempt to restore homeostasis. The catecholamine induced stress response following~     severe burns is particularly exaggerated and manifests detrimentally as inflammation,~     insulin resistance, hypermetabolism, and associated profound protein catabolism. The~     investigators hypothesize that catecholamine blockade will lead to restored IR signaling and~     result in improved post-burn morbidity. The investigators will further determine the~     molecular mechanisms mediating these effects.~   "
134104|NCT01299623|"~     We will develop and evaluate a community-based approach for disseminating comparative~     effective reviews (CERs) about breast cancer prevention to African American women. The~     specific aims of our research, as shown below, will target this population because of~     persistent disparities in breast cancer morbidity and mortality among this population. Our~     primary aims are:~        1. To evaluate uptake of a community-based strategy for disseminating CERs about breast~          cancer prevention to African American women based on sociodemographic characteristics,~          beliefs about medical research, and medical history. We predict that participation in a~          community forum will be higher among women with greater socioeconomic resources, those~          who have a family history of breast cancer, and women who have more positive beliefs~          about research.~        2. To evaluate the impact of evidential versus non-evidential content about breast cancer~          prevention on psychological and behavioral outcomes that include: knowledge of breast~          cancer risk factors and prevention strategies, communication with individuals in their~          social and medical network, and distrust of medical research. We predict that women who~          receive evidential content that is specific for African American women will report~          greater knowledge about breast cancer risk factors and prevention strategies, will be~          more likely to discuss breast cancer prevention strategies with individuals in their~          social and medical network, and will report greater reductions in distrust of medical~          research compared to those who receive non-evidential content.~   "
134095|NCT01299740|"~     Dialectical Behavioral Therapy (DBT) based skill groups for emotionally dysregulated~     children and their parents~      The investigators propose implementing a Dialectical Behavioral Therapy (DBT) skills group~     format for emotionally dysregulated children between the ages of 8 and 12 and their parents.~      Introduction Treatments available for children with emotional dysregulation and behavioral~     problems were shown to be only partially effective.~      DBT combines the western principles of changing behavior with the eastern principles of~     acceptance and mindfulness.~      Efficacy of DBT has been shown across a number of behavioral problems in adults and has been~     successfully adapted for adolescents. The next logical step is modification for younger~     children.~      The investigators chose DBT because of the observed similarities between adults and~     adolescents diagnosed with borderline personality disorder and the children who are referred~     to the investigators clinic with emotional dysregulation.~      Aims: To assess the ability to regulate emotions and problem behaviors before and after the~     proposed intervention~      Method:~      Population: Between 6-10 children between the ages 8-12 will be recruited from The child and~     adolescent psychiatric outpatient clinic at Soroka University Medical Center.~      Inclusion criteria Children suffering from emotional dysregulation All children and at least~     one parent speak Hebrew Exclusion criteria~        1. Schizophrenia~        2. Bipolar disorder~        3. Psychosis i.e an overt thought disorder~        4. Mental retardation~        5. Severe learning disorders~        6. Pervasive developmental disorders.~        7. Children who have suffered brain injury.~      Comparison group: Between 6 and 10 children matched for sex, parents age and education,~     socioeconomic status that fulfill the same clinical criteria for inclusion in the study as~     the study group. The comparison group will receive treatment as usual.~      Procedure The children will participate in a group skills group over 20 sessions, each~     session an hour and a half. The parents will participate in a group skills group over 15~     sessions, each session an hour and a half. Each group will be lead by two therapists. All~     the children will be evaluated by board certified child and adolescent psychiatrist and will~     be diagnosed according to the DSM IV-TR. The parents' the child and a teacher who is~     familiar with the child will fill in questionnaires before the beginning of the group, at~     the end of the group process and 6 months after the group ends.~      The treatment protocol will be based on Linehan's Skills training manual for treating~     borderline personality disorder and on modifications made by Miller for adolescents. The~     groups will be conducted according to a treatment manual which will be written accordingly~     and modified in order to apply the skills to a younger population. Ancillary treatment (~     e.g. pharmacotherapy) will be provided on an as needed basis.~      The control group the data will be collected at similar intervals to those in the study~     group.~      Written informed consent will be obtained from the child and a legal guardian.~        -  ‬~        -  ‬~   "
134096|NCT01299727|"~     Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease~     (LSD) caused by loss in activity of 1 of 9 enzymes necessary for degradation of the~     glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. MPS IIIA results from deficiency~     of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme,~     intermediates of the HS degradation process accumulate in the lysosomes of neurons and glial~     cells, with lesser accumulation outside the brain. MPS IIIA symptoms arise on average at 7~     months of age, with the average age of diagnosis at 4.5 years for the majority of patients.~     Patients present a wide spectrum and severity of clinical symptoms. The central nervous~     system (CNS) is the most severely affected organ system in patients with MPS IIIA, evidenced~     by deficits in language development, motor skills, and intellectual development. In~     addition, there are abnormal behaviors including but not limited to aggression and excess~     motor activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals~     with MPS IIIA have a marked developmental delay and significantly reduced lifespan to 15~     years of age on average.~      The purpose of this study is to collect long term safety and tolerability data in patients~     with MPS IIIA who previously received rhHNS in study HGT-SAN-055 (NCT01155778).~   "
134097|NCT01299714|"~     Researchers at The Ohio State University and the University of Michigan are working together~     to understand cancer of the cervix. One of the areas they are studying is how stress you may~     experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine~     approved by the Food and Drug Administration (FDA) to prevent some types of Human~     Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being~     recruited from the Appalachian region of Ohio.~   "
134098|NCT01299701|"~     This study is designed to characterize the absorption, distribution, metabolism and~     excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg~     (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in~     patients with advanced solid tumors. Metabolic pathways, route (s) of elimination,~     distribution characteristics in plasma and blood, and exposure characterization in plasma~     and blood, and exposure characterization of the parent drug and metabolites will be obtained~     from the study.~   "
134099|NCT01299688|"~     The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork~     for future clinical trials incorporating Her-2 targeted agents in gastric cancer.~   "
134100|NCT01299675|"~     The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of~     the SureScan pacing system when used in an MRI environment according to product labeling.~     This study is required by the Food and Drug Administration (FDA) as a condition of product~     approval.~   "
134101|NCT01299662|"~     Vaccines induce protective immunity against numerous infectious diseases. However, current~     vaccines have limited efficacy against challenging infections like tuberculosis, malaria,~     and HIV. Protein vaccines are safe but, typically they induce weak T cell immunity when~     administered alone. Therefore, special attention is being given to adjuvants, which are~     enhancers of immunity, that cab mature antigen presenting immunostimulatory dendritic cells.~     Our goal is to study in humans the mechanism whereby a synthetic adjuvant, poly ICLC, which~     acts on defined pattern recognition receptors, enhances T an B cell immunity. In preclinical~     studies, our lab has found in mice that poly IC and its analog poly ICLC are superior~     adjuvants for T cell mediated immunity relative to other agonists for PRR. Poly ICLC has~     been extensively studied in humans with a favorable safety profile. In a recently completed~     Phase I study, poly ICLC was found to be safe and well tolerated when administered as a~     single dose of 1.6 mg subcutaneously and intranasally to healthy volunteers. In additional,~     preliminary data shows marked upregulation of gene expression in whole PBMSc following s.c.~     injection of poly ICLC as well as activation of various blood cell type, including dendritic~     cells and monocytes. In this study the investigators propose to extend the evaluation of~     innate immune responses following s.d. injection of poly ICLC to healthy volunteers. The~     investigators propose to characterize poly ICLC effects on specific blood cell types,~     focusing on three different subsets of DC's, by analyzing gene transcriptional changes at~     baseline and at one day following its administration. In order to study the early local~     effects of poly ICLC, which are important for the recruitment and activation of antigen~     presenting cells, the investigators also propose to perform skin biopsies at a skin site~     contralateral to the injection site and at the injection site after poly ICLC injections.~   "
134102|NCT01299649|"~     Retrospective analysis to observe changes in short term mortality~   "
134103|NCT01299636|"~     The purpose of the study is to determine the maximum tolerated dose and the recommended dose~     and to evaluate the safety and tolerability of PM060184.~   "
134105|NCT01299610|"~     This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of~     GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects~     will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2%~     cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All~     subjects will be randomised to receive placebo cream. Three index lesions located on the~     arms and/or legs (one on each) will be identified per subject and each treatment will be~     applied to the same lesion.~   "
134511|NCT01294254|"~     In this study the wound reepithelialization of that part of the skin graft donor site, which~     is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist~     wound healing dressing alone will be investigated.~   "
134106|NCT01299597|"~     The present study will investigate in humans the enzyme inhibition effects of SB-649868 on~     CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as~     single doses: alone, and on two different occasions after repeat doses of SB-649868, at the~     same time as SB-649868 and 2h before SB-649868.~   "
134107|NCT01299584|"~     This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil~     during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not~     described as precautions or warnings and to identify prognostic factors that have an effect~     on the AEs and to assess effectiveness of remifentanil in real clinical practices after~     marketing.~      The subjects are patients prescribed for remifentanil by the investigators at the sites~     based on prescription information in normal clinical practices.~   "
134108|NCT01299571|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of AVODART administered in Korean BPH patients according to the~     prescribing information~   "
134109|NCT01299558|"~     This study is being done to look at the absolute bioavailability of fluticasone furoate and~     GW642444 inhalation powder when administered in healthy subjects. Bioavailability is~     determined by measuring the amount of the dose of inhaled medication that reaches the~     circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared~     to the medication administered intravenously (where bioavailability is 100%).~   "
134110|NCT01299545|"~     Study Design & Objectives:~      Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with~     a clinical follow-up between 12 and 14 weeks.~      To determine the performances of the RA-INF-Dx blood test intended to aid in the~     identification of patients with rheumatoid arthritis who are unlikely to show an initial~     response to infliximab and methotrexate combination therapy evaluated according to EULAR~     response criteria.~      Ancillary study objective:~      To constitute a biocollection of samples associated with all clinical and biological data~     collected at inclusion and at the evaluation visit.~   "
134111|NCT01299532|"~     This is an open, multi-center, non comparative study to evaluate the safety and efficacy of~     Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a~     maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection~     (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed~     for 24 months after last treatment.~   "
134112|NCT01299519|"~     This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%)~     weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.~     Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss~     group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of~     those assigned to group 1, half of the participants will lose 5% of their body weight and~     the other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a~     dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight~     loss). In group 2, research testing will be repeated after six months.~   "
134113|NCT01299506|"~     This is an observational, non-randomized, open label, multicenter, phase IV study, which~     aims to reflect a real-life practice routinely used for the management of advanced soft~     tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to~     receive these drugs in the Netherlands. This study pretends to reflect the use and schedule~     of chemotherapy regimen with trabectedin and/or other conventional care regimens such as~     other palliative chemotherapy/biological therapies or best supportive care (BSC) in the~     management of advanced soft tissue sarcoma patients in the clinic based at the discretion of~     the Investigator.~      There are no pre-defined limits of administered cycles of trabectedin treatments or chemo-~     and/or biological therapy; thus, those treatments may continue as long as deemed necessary~     by the Investigator~   "
134114|NCT01299493|"~     Colorectal cancer is the second leading cause of cancer death and one of the most commonly~     diagnosed malignancies. Screening is effective at reducing incidence and mortality from~     colorectal cancer. This study will evaluate the effectiveness of implementing~     systems-changes in community health centers that facilitate screening.~   "
134115|NCT01299480|"~     This study is to look at a new vaccine that might prevent meningococcal disease, and to look~     at the safety of the new vaccine as well as how well it is tolerated. This study will also~     look at this vaccine being given 2 or 3 times. This study will be done in healthy~     adolescents.~   "
134116|NCT01299467|"~     The purpose of this study is to find out how long the effect of PF-03526299 last after it is~     inhaled by assessing the lung function of mild asthma patients after they have been exposed~     to allergen~   "
134117|NCT01299454|"~     The purpose of this study is to evaluate how much of the investigational product gets into~     the blood stream and how long the body takes to get rid of it when given to subjects with a~     range of liver impairment compared to subjects with normal liver function.~   "
134118|NCT01299441|"~     The purpose of this study is to determine whether the endotracheal cardiac output monitor~     (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory~     changes.~   "
134119|NCT01299428|"~     The aim of the study is to evaluate cerebral oxygenation with Near infrared~     spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.~   "
134120|NCT01299415|"~     This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an~     inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The~     purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and~     ASA404. The purpose of the Extension Phase is to provide continued treatment for those~     patients that have not progressed during the Core Phase and to collect safety data on ASA404~     when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin~     chemotherapy regimen.~   "
134121|NCT01299402|"~     The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal~     mix in powder form and its effects on anxiety and the biomarkers for chronic stress.~   "
134122|NCT01299389|"~     The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate~     as compared with placebo in the treatment of participants with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions [a false belief held in the face of strong differing evidence, especially as a~     symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into~     the self).~   "
134123|NCT01299376|"~     This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan~     potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg~     [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in~     Japanese participants. In the second part, the safety and tolerability of long-term use of~     open-label MK-0954E in participants with hypertension will be evaluated. The primary~     hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic~     blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in~     Japanese participants with essential hypertension who are not adequately controlled~     following a 8-week treatment with filter period study drug of MK-954H.~   "
134124|NCT01299363|"~     This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and~     without vaginal dilator use following surgery for pelvic organ prolapse with traditional~     posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4~     through week 8 after posterior repair will reduce the rate of de novo dyspareunia.~   "
134125|NCT01299350|"~     Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus~     discharge guided by conventional clinical criteria, in patients admitted with acute heart~     failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay~     without worsening the outcome~   "
134126|NCT01299337|"~     The purpose of this study is:~        -  To evaluate liothyronine (Cytomel) as an accelerating agent (i.e. faster rate to~          clinical remission) to electroconvulsive therapy.~        -  To evaluate whether thyroid supplement acceleration can reduce the neurocognitive side~          effect of ECT treatment.~        -  To evaluate whether thyroid status at the time of remission is associated with~          subsequent relapse rate.~        -  To evaluate genetic polymorphisms in enzymes responsible for thyroid metabolism and the~          serotonin transporter promoter gene in depression (5-HTTLRP).~   "
134127|NCT01299324|"~     The primary objective of this feasibility study is to provide clinical data to demonstrate~     the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC)~     produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients~     diagnosed with congestive heart failure (CHF).~   "
134128|NCT01299311|"~     The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin~     sensitivity and lipid metabolism is unclear. Research recently published shows that~     activities associated with everyday activities, summarized as NEAT, such as walking and~     standing, have a much greater role in energy expenditure than exercise. Therefore, the~     objective of the present study is to evaluate the effect of 4 days of inactivity (mainly~     sitting), 4 days of everyday activities (sitting, walking and standing), and 4 days of~     inactivity and exercise (sitting and biking) on glucose metabolism and insulin sensitivity~     using an oral glucose tolerance test, and on lipid metabolism in sedentary, overweight~     people. The investigators hypothesize that:~        1. 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and~          increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight~          people.~        2. 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4~          days of NEAT with equal energy expenditure, in sedentary, overweight people.~        3. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.~   "
134129|NCT01299298|"~     This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50,~     mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will~     receive a single study injection of either mipomersen or placebo. Subjects will be enrolled~     into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design.~     Dose-escalation will proceed only if there is an acceptable safety profile from the previous~     dosing level.~   "
134130|NCT01299285|"~     This is a single dose study of radio-labeled [14C]-LY3009104 in healthy male volunteers to~     study the absorption, distribution, metabolism, and elimination of LY3009104. This study~     requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes~     only and is not intended to treat any medical condition.~   "
134131|NCT01299272|"~     The primary purpose of this study is to assess whether LY2216684 (12 mg to 18 mg once daily)~     is superior to placebo as adjunctive therapy to selective serotonin reuptake inhibitor~     (SSRI) in patients with major depressive disorder (MDD) who were initially partial~     responders to a SSRI in the prevention of re-emergence of depression symptoms in patients~     with MDD who met remission criterion during open label treatment and randomization criteria~     during a stabilization period. This trial consists of two distinct periods; an open label~     treatment period, which consists of two parts, 8 weeks open label with movement to 10-12~     weeks open label stabilization IF patients are in remission at end of 8 weeks (open label~     for 18 to 20 weeks total) followed by a randomized blinded period for 24 to 26 weeks.~   "
134132|NCT01299259|"~     The investigators hypothesize that text message reminders to girls diagnosed with pelvic~     inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their~     primary care provider (PCP) after being discharged from the ED.~   "
134133|NCT01299246|"~     Objectives:~      Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is~     a critical in rural regions. The objective is to present on the association of non-invasive~     DFP assessment tools and physiological indicators for the early detection of DFP among rural~     cases of diabetes in Taiwan.~   "
134134|NCT01299233|"~     To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real~     Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT,~     Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness~     (RNFL) circle scan-measurements.~        -  Trial with medical device~   "
134135|NCT01299220|"~     This study will look at if a low-dose regimen of acitretin is helpful in treating a skin~     rash caused by the chemotherapy drug, erlotinib.~   "
134168|NCT01298791|"~     Patient satisfaction is affected by physician communication styles and communication at the~     bedside. The investigators are conducting a randomized controlled trial involving both~     providers and families to determine if providers sitting down while talking with families,~     will improve one aspect of quality care delivered during an inpatient stay as measured by~     patient/family satisfaction. The investigators will additionally study the affects of the~     intervention on the following outcomes: family assessment of provider communication,~     readmission rates, and length of stay.~   "
134136|NCT01299207|"~     Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries.~     The introduction of drug-eluting (coated) stents into clinical practice is regarded as a~     revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries~     after percutaneous coronary interventions are performed. There has been, however, concerns~     of increased risk for clot formation in the heart arteries of patients treated with~     drug-eluting stents. Therefore, in order to lower the risk of clot formation, it is~     recommended that patients receiving these types of stents, be treated with dual antiplatelet~     therapy (blood thinning medication) for one year. The effect of this strategy, however, on~     clot formation and bleeding complications when utilizing newer generation stents, such as~     the Xience: Everolimus-eluting Stent, have not been well described.~      Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular~     events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic~     stroke, and severe bleeding in relation to the timing and discontinuation of dual~     antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to~     patients that do not discontinue dual antiplatelet therapy.~   "
134137|NCT01299194|"~     Statins are a class of drug used to prevent heart attacks and strokes by lowering blood~     cholesterol levels. They have also been found to have a beneficial side effect of lowering~     the level of inflammation in the body. This is thought to be one of the reasons they are~     effective in treating heart attacks and strokes. Laboratory experiments have shown that~     statins reduce lung inflammation in response to bacteria and this is a promising development~     for the treatment of chest infections.~      Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum~     production and recurrent chest infections. 2/3 of patients are chronically colonised with~     bacteria (normally the lungs are sterile) and this leads inflammation in the lung and in the~     rest of the body.~      There are no effective treatments for bronchiectasis other than antibiotics for chest~     infections. With increasing antibiotic use, there is increasing antibiotic resistance and~     new treatments for this disease are needed.~      The investigators intend to study Atorvastatin in patients with bronchiectasis with~     colonization with pseudomonas aeruginosa. The investigators will give Atorvastatin to 16~     patients with this disease while 16 patients will receive placebo. This will be a crossover~     study where patients will receive atorvastatin or placebo for 3 months, followed by a statin~     wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving~     atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin~     for 3 months. The investigators will measure inflammation in their lungs and in the rest of~     their body before and after treatment with atorvastatin. The investigators will also assess~     their quality of life and number of chest infections over a 7.5 month period.~      This pilot study will determine if there is any role for statins are an anti-inflammatory~     agent in patients with bronchiectasis.~   "
134138|NCT01299181|"~     The investigators hypothesise that long term statin treatment will improve patients'~     symptoms through its anti-inflammatory effect. The beneficial effects on patient symptoms~     (cough, sputum volume, bacterial load, airway function, exercise tolerance, exacerbation~     frequency and health related quality of life) will be consequent on reduced neutrophilic~     airways inflammation.~   "
134139|NCT01299168|"~     The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the~     Banff Classification which represents arbitrary international consensus. Recent data-driven~     approaches using molecular and conventional technologies indicate that mere consensus~     produces frequently incorrect diagnoses with potential harm to patients due to inappropriate~     treatment. To address this unmet need and improve diagnostics in the area of organ~     transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new~     diagnostic system that combines the molecular and histopathological features of transplant~     biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic~     System. The present study will validate and refine this system in 500 prospectively~     unselected biopsies for clinical indications from American, Canadian and European centres in~     addition to 300 biopsies already collected. Thus this is the extension of the INTERCOM study~     (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in~     routine patient care and clinical trials, the study will develop and optimize a transparent~     and user-friendly reporting format to communicate this information to clinicians and obtain~     detailed feedback on how this system can best improve patient care.~   "
134140|NCT01299155|"~     To prospectively evaluate postoperative visual and refractive parameters in a series of~     subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with~     LENTIS MPlus Intraocular Lens (IOL).~   "
134141|NCT01299142|"~     The purpose of this study is to determine the safety and tolerability of the anti-TSG101~     human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy~     volunteers.~   "
134142|NCT01299129|"~     Purpose:~      To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated~     cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in~     conjunction with thorough visual function testing.~      Methods:~      28 patients with uveitis-associated CME were examined before intravitreal triamcinolone~     injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection.~     Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function~     testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading~     speed using a standardized German-language test (Radner Reading charts), contrast~     sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled~     microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid~     consisting of a central locus and three concentric box-shaped stimulation areas. The changes~     of retinal anatomy over time were compared to the respective outcome of visual function.~   "
134143|NCT01299116|"~     In the proposed study, women aged 18-29 seeking oral or injectable contraception will be~     offered an opportunity to try LARC instead; the FDA-approved options include two types of~     intrauterine products and one type of subdermal contraceptive implant. Over a 24 month~     period, the experiences of LARC users will be compared to the experiences of those opting~     for their initial short-acting method.~   "
134144|NCT01299103|"~     The study will enroll and treat a patients to assess improvement in the appearance of facial~     wrinkles.~   "
134145|NCT01299090|"~     Use of RF device to treat wrinkles of the neck~   "
134146|NCT01299077|"~     The purpose of this study is to observe the overall satisfaction of patients with~     degenerative disc disease after receiving triple therapy.~   "
134169|NCT01298778|"~     In previous studies the investigators have seen that the severity of pain one day after~     cesarean delivery can predict the presence of pain and depression 2 months later. The~     investigators believe those at risk for severe acute post-partum pain can be identified, and~     medical interventions can be tailored to manage postoperative pain more effectively.~   "
134170|NCT01298765|"~     The purpose of this study is to determine whether BEMA Buprenorphine is safe in the~     treatment of chronic pain.~   "
134147|NCT01299064|"~     Preliminary evidence attests to the effectiveness of mindfulness-based interventions in~     reducing symptoms associated with a variety of medical and psychological conditions.~     However, research progress has been hampered by discrepancies in how mindfulness has been~     operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness~     were developed exclusively by Western scientists and have exhibited questionable validity,~     particularly among diverse cultural groups. Operational definitions of mindfulness are~     essential for the development of valid measures, which in turn are necessary for~     investigating the mechanisms of change in mindfulness-based interventions. Therefore, the~     overall goal of this study is to create a mindfulness measure that is informed by the~     experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay~     practitioners. To do so, this study will employ the preliminary phases of the sequential~     exploratory mixed methods for instrument design model. The first phase will involve~     conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay~     practitioners to ascertain expert information on mindfulness and closely related Buddhist~     concepts. This qualitative process allows the experts to define the phenomena of interest~     (i.e., addresses issues of validity). In the second phase, the investigators will use the~     themes and specific phrases evoked during the qualitative interviews to develop items for a~     draft closed-ended self-report measure of mindfulness. Following completion of the research~     outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly~     evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of~     different cultures and contexts. This measure can be beneficial in clinical research by~     helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the~     United States and equally so in other cultures such as Thailand, where mindfulness and other~     Buddhist practices have already been integrated into mainstream mental health treatment.~     Therefore, our aim is to create a measure that can help improve the assessment and clinical~     use of mindfulness.~   "
134148|NCT01299051|"~     The proposal of this study is to compare the effectiveness of two worksite weight management~     programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive~     Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for~     participants in the study who agreed to be contacted for future research.~   "
134149|NCT01299038|"~     Research studies have shown a strong association between cancer and blood clots in the veins~     (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary~     embolism) which in severe cases may be life threatening. Studies have demonstrated that~     increases in microparticles may contribute to the development of deep vein thrombosis in~     cancer patients. The purpose of this research study is to see if rosuvastatin lowers the~     number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles~     that are generated from different types of blood cells in the body. In people who have~     cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor~     for deep vein thrombosis.~   "
134150|NCT01299025|"~     The aim is to evaluate balance training using Nintendo Wii Fit. The hypothesis is that a~     period of training will increase balance capacity och self-efficacy.~      People with diagnosed multiple sclerosis are invited to participate. Estimation of study~     power gave that 29 people in each group was necessary to detect a difference in the primary~     outcome measure, Timed Up and Go test.~      Other measures used are the Four square step test, Dynamic Gait Index, Timed stands test, 25~     foot walking test, 12-item Walking scale and the ABC scale.~      Participants were randomised to either training or control. The training consisted of 6~     weeks training with Nintendo Wii Fit 30 minutes 2 times a week.~   "
134151|NCT01299012|"~     Evaluating the use of Liraglutide in patients with Type 1 Diabetes.~   "
134152|NCT01298999|"~     The purpose of this study is to determine whether treatment with an experimental drug called~     YF476 in patients with Barrett's esophagus reduces the expression of tissue markers that are~     associated with an increased risk of developing esophageal cancer.~   "
134153|NCT01298986|"~     Rationale: To determine the most beneficial ablation methodology for individual patients~     with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as~     surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place~     the epicardial and endocardial ablation lines.~      Objectives: Catheter and surgical ablation are being offered today to patients with drug~     refractory and symptomatic atrial fibrillation. This study is designed to assess the most~     efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation.~     In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein~     isolation performed surgically will be combined with right and left atrial flutter lines~     performed using a transcatheter approach) will be compared to percutaneous catheter ablation~     to isolate the pulmonary veins and apply the left and right atrial flutter lines with~     removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the~     Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.~      Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at~     6 months will demonstrate that the Hybrid approach is going to be a: superior to~     percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior~     when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.~      We hypothesize that the safety of all procedures will show no differences and that there~     will be no differences in clinical complications between groups.~   "
134154|NCT01298973|"~     The purpose of this study is to look at the ability of Viscoat to ensure proper wound~     closure.~   "
134155|NCT01298960|"~     Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation~     treatment improves ovarian response in women with previous poor ovarian response.~   "
134156|NCT01298947|"~     The objective of this study is to evaluate the safety and efficacy of preparing a vessel~     with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to~     local Paclitaxel delivery compared to local Paclitaxel delivery without initial~     photoablation~   "
134157|NCT01298934|"~     LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces~     cell death by allowing for the expression of certain suppressed genes that are important in~     regulating cell survival. Based on laboratory studies, the hypothesis is that this drug will~     selectively kill the stem cells responsible for causing myelofibrosis and result in~     reduction in spleen size and ultimately restoration of normal bone marrow function.~   "
134171|NCT01298752|"~     The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic~     Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following~     cataract surgery.~   "
134172|NCT01298739|"~     Asthma control study 2011~   "
134173|NCT01298726|"~     The purpose of this study is to examine the effect of a pharmaceutical care program on the~     level of glycated hemoglobin for hyperglycemic users of brazilian public health care system~     in drug treatment for type 2 diabetes.~   "
134512|NCT01294241|"~     The purpose of this study is to compare intra-individually the efficacy and tolerance of~     Sericare® versus standard treatment in accelerating the epithelialization of skin lesions of~     patients with Epidermolysis bullosa hereditaria.~   "
134158|NCT01298921|"~     Cluster headache is a disorder marked by frequent attacks of short-lasting, severe,~     unilateral head pain with associated autonomic symptoms. It is the most severe head pain~     syndrome known. Currently, the two most common treatments for cluster headaches are inhaled~     oxygen and injectable sumatriptan. These treatments do not work for all cluster headache~     patients, and patients who smoke may eventually develop contraindication to triptans. New~     treatment options are needed.~      An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve~     that is controlled by respiration rate, allowing increased oxygen flow in response to~     increased demand. This system may be more efficacious at stopping a cluster headache attack~     than the currently prescribed oxygen delivery system.~      This study will compare the effectiveness of oxygen delivered via demand valve versus~     continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster~     headache attack. All patients will treat one cluster headache with each of the 2 treatment~     methods.~   "
134159|NCT01298908|"~     Randomized controlled trial, a method used to implement the random allocation sequence is~     numbered containers.~      The aim of the study is to compare operative treatment, ultrasound guided laser ablation and~     ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great~     saphenous trunks. On the grounds of the available data, the study hypothesis is that using~     laser or operative treatment more than 20 percent better outcome can be achieved compared to~     foam sclerotherapy.~   "
134160|NCT01298895|"~     The purpose of the study was to evaluate optical ocular components in patients with~     pseudoexfoliation syndrome using optical low coherence reflectometry. A prospective cohort~     study of 224 eyes of patients planned for cataract surgery was conducted from January 2009~     until July 2009. Patients were divided in two groups: the first group of 47 eyes with~     cataract complicated with pseudoexfoliation syndrome and the control group of 177 eyes with~     uncomplicated cataract. Each group was further divided into two subgroups based on its~     refractive state: emmetropes and hypermetropes. The optical low coherence reflectometry~     biometer LENSTAR® LS 900® was used to define ocular optical components.~   "
134161|NCT01298882|"~     Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)~     inhibition with diacerein administration on insulin secretion and metabolic control of~     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.~      Hypothesis. Diacerein administration improves insulin secretion and metabolic control of~     drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.~      Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.~     Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements:~     A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as~     well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin~     secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for~     the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses:~     Wilcoxon signed rank and Mann-Whitney U test.~   "
134162|NCT01298869|"~     Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil.~     Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical~     intraepithelial neoplasia than did those in the placebo group. The immunogenicity and~     efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD)~     population. The cellular and humoral immune responsiveness of CKD population are impaired by~     the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the~     vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need~     to be adjusted, mostly increase in CKD patients.~      This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination~     (Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and~     compare to non-CKD patients. Although a minimal peak anti-HPV response associated with~     protective efficacy has not been determined, the equivalent immune response in CKD and~     non-CKD patients if can be demonstrated by this study should be extrapolated to the CKD~     population. If less immune response results, the more intense dose/schedule of the vaccine~     should be further studied.~   "
134163|NCT01298856|"~     There will be a difference in ankle functional ability between athletes with chronic ankle~     instability in the intervention group and in the control group.~   "
134164|NCT01298843|"~     The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.~   "
134165|NCT01298830|"~     The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with~     space-occupying intracerebral hemorrhage.~   "
134166|NCT01298817|"~     The main objectives of this study are to collect pilot data to assess feasibility (accrual,~     retention, compliance), to estimate the variability of outcome measures, and to obtain~     preliminary estimates of treatment efficacy based on group differences in body composition~     (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors~     including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein,~     IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and~     muscle strength. While this is just a pilot study, randomization will be used so that the~     investigators can obtain a realistic estimate of accrual (which is often less in a~     randomized trial) and an unbiased estimate of treatment efficacy.~      The investigators will accomplish these objectives by conducting a 2-arm, 3-month~     randomized, clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist~     circumference ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women.~     Participants will be randomized to a soy-based or animal-based, 3-month, hypocaloric dietary~     intervention to achieve our specific aims:~      Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month~     soy-based meal replacement weight loss intervention and assess the study participant's~     ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).~      Secondary Aims:~        1. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on measures of body composition, including abdominal (total,~          subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body~          weight, waist/hip circumference); and whole body fat and lean mass.~        2. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on biomarkers of cardiometabolic risk including~          glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6),~          blood pressure and lipids (HDL, LDL, TC, TG).~        3. To estimate the variability of and obtain preliminary estimates of the effect of the~          soy-based meal replacement on physical function (short physical performance battery,~          400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh~          muscle).~        4. To document any adverse events associated with the soy-based meal replacement.~   "
134167|NCT01298804|"~     Maternal depression disproportionately affects low-income and minority women, and has~     profound negative impacts on their children. The investigators are conducting a randomized~     trial of a systems approach to identify mothers at risk for depression in Head Start - a~     federally funded early learning program for children of low-income families - and to provide~     an on-site intervention to prevent or alleviate depressive symptoms; improve functioning;~     and, where appropriate, proactively link mothers to more definitive mental health services.~   "
134174|NCT01298713|"~     Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation~     anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is~     lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases.~     The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This~     study is aimed to check if the inhibition of this signal transduction pathway by a synthetic~     mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.~   "
134175|NCT01298700|"~     This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution~     compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular~     hypertension.~   "
134176|NCT01298687|"~     The purpose of this study is to compare the incremental dosing of travoprost ophthalmic~     solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in~     patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).~   "
134177|NCT01298674|"~     This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM)~     Degeneration in Portugal.~   "
134178|NCT01298661|"~     Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that~     affects the quality of life and increases mortality of these patients. So, exercise tests~     are considered as an essential component of the clinical evaluation of the patients with~     COPD. The objective of this study is to evaluate the reproducibility sensitivity and~     validity of the Six Minute Step Test (6MST) in patients with COPD and in health volunteers,~     and verify its relation with the Body-Mass Index, Airways Obstruction, Dyspnea and Exercise~     Capacity Index (BODE). This Observational, Transversal, Prospective study will be conducted~     in the Special Unit of Respiratory Physiotherapy, of the Federal University of São~     Carlos. To participate in this study, 120 subjects, both gender, will be invited and will~     be allocated in five groups: Group I (30 healthy young subjects of 17 to 27 years old),~     Group II (30 healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80~     years old, with mild, moderate, severe and very severe obstruction determined by the forced~     expiratory volume in one second (FEV1) by forced vital capacity (FVC) relation FEV1/FVC~     <70% and FEV1 in predict percentage < 80% composing the Group III (20 COPD patients in GOLD~     stage I), Group IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages~     III and IV). All subjects will be submitted to body composition and anthropometric~     assessment, pulmonary function test, three 6-minutes walk test (6MWT) and three 6MST.~     Furthermore, the patients of the groups III, IV and V will answer the Modified Medical~     Research Council (mMRC) scale, and BODE index will be calculated to each of them.~   "
134179|NCT01298648|"~     This study will be conducted to assess adverse drug reactions, incidence of adverse events,~     and factors that may affect the safety and effectiveness of Humira for the treatment of~     Crohn's disease.~   "
134180|NCT01298635|"~     Primary angle closure glaucoma (PACG) is caused by contact between the iris and trabecular~     meshwork, which in turn obstructs outflow of the aqueous humor from the eye. This contact~     between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork~     until it fails to keep pace with aqueous production, and the pressure rises, and at last the~     optic nerve is damaged, the vision may be lost in some severe cases. Therefore, ocular~     pressure reduction is the key to treat the disease and prevent blindness. Trabeculectomy is~     the most common conventional surgery performed for glaucoma. This allows fluid to flow out~     of the eye through this opening, resulting in lowered intraocular pressure(IOP) and the~     formation of a bleb or fluid bubble on the surface of the eye.~      Cataract surgery is common in the elderly. Cataract surgery is the removal of the natural~     lens of the eye (also called crystalline lens) that has developed an opacification, which~     is referred to as a cataract. Cataract extraction includes intracapsular cataract~     extraction, extra capsular cataract extraction & phacoemulsification, and~     phacoemulsification is the preferred method. It has been reported that IOP reduction could~     occur in cataract patients with PACG after the cataract surgery. For some cases with PACG,~     such IOP reduction may be insufficient for neuronal protection, and many patients still~     require glaucoma medication and incisional surgery such as trabeculectomy to control IOP. In~     such cases, a combined cataract-glaucoma procedure (phacotrabeculectomy) is a reasonable~     option. In keeping with this concept, previous studies have shown that phacotrabeculectomy~     could effectively and simultaneously reduce IOP and improve vision in patients with a~     coexistence of PACG and vision-threatening cataract. However, phacotrabeculectomy may~     heighten inflammatory response, result in a higher frequency of postoperative complications~     such as hyphema and fibrin in the anterior chamber, endophthalmitis, and increased scarring~     of the filtering bleb. Thus, it is unclear whether phacotrabeculectomy is as effective and~     safe as trabeculectomy in lowering IOP for PACG patients.~      In the present study, the investigators compared the efficacy and safety of~     phacotrabeculectomy and trabeculectomy in patients with coexisting PACG and cataract.~   "
134181|NCT01298622|"~     To investigate the structural/functional abnormalities and the possible genetic~     endophenotypes of Obsessive-compulsive disorder (OCD) patients and their core families.~   "
134182|NCT01298609|"~     The study is designed as a prospective, randomized, double-blind, single center study with a~     6 month duration post permanent system implantation. Forty patients will be implanted.~      During trial stimulation, patients will be randomized into one of two study arms for two~     weeks. Crossover will occur at the 2 week study visit to the opposite group. After~     completion of these two arms, every patient will subsequently complete participation in the~     third study arm.~      After completion of the third arm, patients will be evaluated to determine if they are a~     positive responder responder. If so, the patient will have the option of obtaining the~     permanent implant.~   "
134183|NCT01298596|"~     The purpose of this study is to compare the rate of recurrence of cervical intraepithelial~     neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of~     follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women~     receiving cryotherapy versus LEEP over 3 weeks of follow-up.~   "
134184|NCT01298583|"~     The purpose of this study is to compare the improvement in ankle control and brain~     activation in subjects with stroke resulting from two different forms of telerehabilitation:~     tracking training, emphasizing accurate movements, versus movement training, involving~     simple movements.~      Hypotheses:~        1. The Track group will show greater improvement in ankle range of motion compared to the~          Move group.~        2. The Track group will show greater improvement in ankle tracking accuracy and greater~          changes in fMRI (increase in relative volume of activation for ipsilesional~          sensorimotor cortex, increase in laterality index, and decrease in~          blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.~        3. The Track group will show greater improvement in tracking accuracy at an untrained~          joint (knee) compared to the Move group.~        4. The Track group will show greater improvement in standing balance.~        5. The Track group will show greater improvement in walking speed and ankle dorsiflexion~          during gait compared to the Move group.~   "
134185|NCT01298570|"~     This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed~     to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI~     (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.~   "
134186|NCT01298557|"~     The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic~     brain injury (TBI) are due to selective disruption of the long association white matter~     tracts of the cerebral hemispheres, with resulting functional impairment of the network of~     cortical regions that are interconnected by these long-range association pathways. We~     propose that traumatic white matter injury can be measured with diffusion tensor imaging~     (DTI) and that the impaired cortical activation can be detected with magnetoencephalography~     (MEG), and that the results of these imaging examinations will correlate with neurocognitive~     status and functional recovery after TBI.~   "
134187|NCT01298544|"~     In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received~     either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular~     Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3~     years after the last vaccination) will assess the antibody concentrations in children who~     previously completed Wyeth study 0887X-101518.~   "
134188|NCT01298531|"~     This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of~     etanercept with that of placebo in adult subjects with axial Spondyloarthritis.~   "
134189|NCT01298518|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the safety and tolerability, and~     pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.~   "
134190|NCT01298505|"~     The purpose of this study in healthy people is to investigate the safety, toleration and~     time course of PF-03654764 in the blood, following multiple doses given by mouth together~     with fexofenadine.~   "
134191|NCT01298492|"~     This study provides open-label drug to eligible patients who have completed a prior study of~     PF-00547659. The primary endpoint for this study is long-term safety.~   "
134192|NCT01298479|"~     The purpose of this study is to determine the volumetric delivery of the Uniject.~   "
134193|NCT01298466|"~     A0081256 is a prospective, open-label, multi-centre European study designed to raise~     awareness and enhance the diagnosis of patients with chronic low back pain with a~     neuropathic pain component in primary care who are refractory to standard analgesic therapy~     and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of~     pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction~     with treatment, patient anxiety and depression, sleep interference, physical functioning and~     work productivity will be assessed.~   "
134194|NCT01298440|"~     Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is~     correlated to treatment success.~   "
134195|NCT01298414|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is looking at biomarkers in bone marrow samples from young~     patients with acute myeloid leukemia.~   "
134196|NCT01298401|"~     RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such~     as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Specialized~     radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a~     high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage~     to normal tissue.~      PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when~     given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab,~     capecitabine, and maintenance therapy in treating patients with locally advanced cancer of~     the pancreas.~   "
134197|NCT01298388|"~     RATIONALE: Studying medical records and collecting questionnaires from patients who were~     enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors~     learn about long-term effects of treatment and plan the best treatment.~      PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute~     lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741,~     EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.~   "
134198|NCT01298375|"~     Type 2 diabetes (T2D) is a global burden disease affecting almost 200 million people and is~     expected to nearly double by 2030 (1). It is imperative that this disease is kept under~     control, and that we begin to reverse the direction of its incidence. We propose to start by~     identifying the physiological and molecular aspects of the problem in all spectrums of the~     disease (ie from insulin sensitive athletes to sedentary lean and obese individuals and~     further to overt type 2 diabetics), and focus our efforts on examining the differences and~     identifying the stages of progression for possible targets of future intervention. The~     proposed study Metabolic Phenotyping is novel in its target populations and innovative in~     its use of state-of-the-art techniques. We hypothesize that the in vivo differences in~     metabolic flexibility and mitochondrial function between endurance athletes and type 2~     diabetics and their lean and obese controls are retained in vitro and will offer a new model~     in which to study the underlying mechanisms of the progression of T2D.~   "
134199|NCT01298362|"~     The purpose of this study is to identify the combined impact on bone loss as well as the~     incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast~     cancer treated with an aromatase inhibitor (AI) either as first line therapy or as~     maintenance therapy after initial treatment with chemotherapy, in real life clinical~     settings in Greece.~   "
134224|NCT01298037|"~     This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort~     Study NCT01263587. This study will examine the balance between immune regulatory and~     effector responses in hepatitis B-infected participants enrolled in the HBRN study~     (NCT01263587).~   "
134225|NCT01298024|"~     The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus~     conventional treatment (late exercise) in patients with acute non-operative achilles tendon~     rupture (ATR).~   "
134226|NCT01298011|"~     The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are~     effective in treating patients with operable pancreatic cancer.~   "
134227|NCT01297998|"~     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus~     cisplatin combination therapy in patients with biliary tract cancer undergoing resection~     without major hepatectomy.~   "
134200|NCT01298349|"~     The present study aimed to examine face and object perception processes in schizophrenic~     patients. Schizophrenia is associated with deficits in visual processing that represent a~     key feature in the disorder. Previous studies have shown that schizophrenics exhibit~     deficits in a variety of facial-processing tasks (e.g., face recognition, recognition of~     facial expressions), that may severely hinder the patients' interpersonal and social skills.~     Some investigators have attributed these deficits to impairments in configural processing in~     schizophrenia. That is, an impairment in the ability to process the spatial relations~     between the constituent parts of a configuration (e.g., the spacing between the eyes of a~     given face). To date, studies aimed to investigate this possibility (e.g., Schwartz et al.,~     2002; Yong-Wook et al., 2008) yielded conflicting results. Additionally, it is not yet clear~     whether the hypothesized impairment in configural processing is restricted to faces, or~     whether it is more general in nature and applies to objects as well.~   "
134201|NCT01298336|"~     The purpose of this study is to determine the 6-months sputum conversion rate with a~     clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary~     infection.~   "
134202|NCT01298323|"~     The purpose of this study is to evaluate the effect of patient outreach program on the~     proportion of time patients with MTC experience moderate or severe AEs during first 12~     months of treatment with vandetanib~   "
134203|NCT01298310|"~     To characterize the phenotype in patients with Morton's neuroma and to explore the effect of~     local administration of Xylocaine (lidocaine)~   "
134204|NCT01298297|"~     The purpose of this study is to determine whether sublingual buprenorphine is effective in~     the treatment of acute pain in adult patients with extremity bone fractures~   "
134205|NCT01298284|"~     New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB~     added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.~   "
134206|NCT01298271|"~     Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection~     obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal~     bleeding.~   "
134207|NCT01298258|"~     The investigators hypothesize that the different components of arterial load are coupled~     with different components of LV function. The regional ventriculo-arterial couplings may be~     important in the pathogenesis of heart failure and ventricular remodeling, and in the~     prediction of future cardiovascular events.~   "
134208|NCT01298245|"~     The primary purpose of the study is to investigate allele frequencies of candidate genes in~     Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese~     diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus~     examination (either by an ophthalmoscope or fundus camera) within 6 months before the study~     will be recruited for the study. Each subject will receive anthropometric and blood pressure~     measurements. Then, fasting blood samples will be taken for the measurements of glucose,~     HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for~     DNA extraction from buffy coat. Meanwhile, the participant will receive structural~     questionnaires for demography, personal history, medical history and concomitant medication.~     Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions~     will be genotyped by using the ABI TaqMan assays. The differences in the distribution of~     genotypes and alleles between the study groups will be analyzed using appropriate~     statistical methods. Through the study, the investigators hope to build up a platform for~     future large-scale genetic studies of diabetic retinopathy. The investigators also hope to~     set up priority of candidate loci for future studies.~   "
134209|NCT01298232|"~     Left ventricular systolic time intervals, including pre-ejection period (PEP), ejection time~     (ET), and their ratio (PEP/ET), is determined by the systolic and diastolic function and~     ventriculo-arterial coupling. The investigators have shown the usefulness of the~     electromechanical activation time (EMAT, equals PEP minus isovolumic contraction time) in~     the prediction of cardiac mortality or re-hospitalization for heart failure in patients with~     the acute heart failure syndrome (AHFS). Therefore, the objective of the present proposal is~     to compare 12-month outcomes of EMAT-guided vs symptom-guided heart failure therapy in~     patients with AHFS.~   "
134210|NCT01298219|"~     The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone~     administration in subjects with~      OBD.~   "
134211|NCT01298206|"~     The pandemic A/H1N1 virus was named swine flu when the current outbreak started. Although~     it is not yet confirmed that the index case acquired the virus from pigs, the nomenclature~     swine flu was due to the fact that the virus is triple-reassortant with genes from swine,~     avian, and human influenza origins. A total of 57,809 cases were reported in the WHO EMRO~     region, 693 of whom have died (1.2% case fatality). Lebanon had 1,838 confirmed cases with 5~     deaths, it is estimated that 4% of these cases required hospitalization. Most cases of~     pandemic influenza presented with fever, cough, and sore throat. Other common symptoms~     included myalgia, headache, and rhinorrhea. The pandemic A/H1N1 virus appears to be very~     successful at human-to-human transmission. It is also causing infections beyond the~     traditional seasonal variation of previous human influenza viruses. Unlike seasonal~     influenza viruses that usually cause severe infections requiring hospitalization among the~     elderly and children under 5 years old, the pandemic A/H1N1 viruses are causing more severe~     illness among young adults. Several reports have associated certain underlying conditions~     with severe illness. Such conditions were pregnancy, asthma, diabetes, obesity, and heart~     disease.~   "
134240|NCT01297075|"~     The aim of this project is to motivate and support general practice clinics in implementing~     the visions and recommendations presented in two of the disease specific programmes for~     chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These~     programmes describe evidence based treatment and division of tasks between the~     municipalities, the hospitals and general practice.~      The Facilitator Project is funded by The Danish Ministry of Interior and Health.~   "
134241|NCT01297868|"~     Objective The investigators assessed the acute impact of physical exercise on retinal vessel~     regulation. This might be of clinical importance if retinal vessel regulation is examined~     with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age~     range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal~     examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h)~     intense exercise of 20 minutes.~   "
134212|NCT01298193|"~     This is a prospective, multicenter, open label, non-comparative trial in Spain.~      The primary objective of this study is to determine the complete response, defined as no~     vomiting and no use of rescue treatment, in women with early-stage breast cancer treated~     with one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of~     CINV(Chemotherapy-induced nausea and vomiting) day 1, 5-HT3 antagonist plus 3 days of~     dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and~     tolerability of aprepitant in the second cycle among patients who failed to the previous~     CINV prevention treatment.~      The study will focus on early-stage chemonaïve breast cancer patients receiving~     docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV~     prevention. The CINV incidence in those patients will be evaluated on the first cycle. All~     refractory patients, will be asked to participate in the second phase, where aprepitant on~     days 1, 2 and 3 will be added to their antiemetic regimen.~      Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated~     that around 48 patients will enter the efficacy phase.~      The duration of the study, from first patient visit to last patient visit will be~     approximately 21 months.~   "
134213|NCT01298180|"~     The purpose of this study is to estimate the sensibility at the growth hormone in vivo at~     the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting~     a deficit in growth hormone (GHD).~   "
134214|NCT01298167|"~     The purpose of the study is to look at which nonpermanent superficial closure method,~     cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and~     functional outcome in repairs of facial wounds after Mohs surgery.~   "
134215|NCT01298154|"~     The purpose of this protocol is to study the effects of intact and hydrolyzed yellow pea~     protein, compared to intact and hydrolyzed whey protein, on satiety, food intake, and~     glucose metabolism in healthy young men. The specific objective is to investigate the~     effects of 20 g available protein for 4 different protein types (intact and hydrolyzed pea~     and whey proteins) and water (control) on satiety, food intake and blood glucose before and~     after a meal. The specified amount of protein was chosen based on our previous studies on~     intact pea protein suggesting that 20 g may reduce food intake and pre-meal blood glucose 30~     minutes before a test meal. Whey protein has been chosen as a reference protein because it~     has been extensively studied and its effects on blood glucose and food intake are being~     elucidated within our laboratory.~   "
134216|NCT01298141|"~     The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients~     with Fabry disease.~   "
134217|NCT01298128|"~     The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and~     medications are delivered locally. It has been proven to be as safe and effective as the~     combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to~     minimal systemic absorption. Following a single vaginal insertion, steroid concentrations~     remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to~     better compliance, tolerability and acceptance by patients requiring ovarian suppression~     prior to COH for IVF.~   "
134218|NCT01298115|"~     This prospective observational study is designed to find out what treatment options new~     patients with chronic kidney disease learn about from their renal unit.~      Aims: To determine the proportion of new CKD patients who receive information about~     treatment options prior to commencing dialysis, pre−emptive transplantation or conservative~     management. To determine the timing (i.e. patient's stage of disease) when information is~     given. To find out whether patients have a friend or family member with them when~     information is given.~      Research Design and methods: This study is an assessment of CKD education practices.~     Nephrologists and pre−dialysis coordinators from each renal unit will complete~     questionnaires about information that was given to each new dialysis, pre−emptive transplant~     or conservatively managed patient that started treatment during a 3 month period.~      Study hypothesis: Approximately one third of CKD patients will receive information after~     starting treatment. There will be a positive association between in−centre haemodialysis and~     later referral, non−English speaking background, and advancing age. Significance: The~     results from this national audit will provide Australian nephrologists and renal nurses with~     evidence about CKD education practices and compliance with clinical practice guidelines. The~     results may highlight opportunities for improvement in practice.~   "
134219|NCT01298102|"~     In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about~     vaccination. There is no data concerning the immunogenicity nor the security of the~     adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the~     effects of this vaccine on transplanted and hemodialyzed patients.~   "
134220|NCT01298089|"~     A study of flap thickness predictability in patients submitted to Laser in Situ~     Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).~   "
134221|NCT01298076|"~     The specific aims of the study are to test the following hypotheses:~        -  That there is a difference in change in visual acuity resulting from treatment with~          intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced~          macular oedema~        -  That there is a difference in degree of resolution of macular oedema resulting from~          treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes~          with advanced macular oedema~        -  That both intravitreal bevacizumab and dexamethasone implants have a manageable and~          acceptable safety profile in eyes with diabetic macular oedema~   "
134222|NCT01298063|"~     Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at~     highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose~     or two lower doses) and 8 healthy matched controls to each of this two groups.~   "
134223|NCT01298050|"~     Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the~     survival rate in patients with refractory cardiac arrest (CA). Recent studies have also~     highlighted the potential early application of this method in improving the prognosis of~     prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The~     rationale for use of ECMO in these patients is to optimize early perfusion of vital organs,~     curing the cause of CA and waiting for the recovery of the injured myocardium. The~     investigators have created a flow-chart to decide which patients are eligible. The aims of~     this study are to evaluate if, with this flow-chart, the investigators are able to detect~     which patients have more probability of survival.~   "
134228|NCT01297985|"~     This randomized controlled trial tests the efficacy of a mental health peer-led educational~     intervention called BRIDGES (Building Recovery of Individual Dreams and Goals through~     Education and Support). The BRIDGES program is a 10-week, manualized education course~     designed to provide basic information about the etiology and treatment of mental illness,~     self-help skills, and recovery principles in order to empower participants to return to~     valued social roles within their communities. BRIDGES is a peer-led program and all~     instructors are adults with mental illnesses.~      Hypothesis #1: Compared to wait-list controls, intervention participants will report~     increased feelings of psychological empowerment.~      Hypothesis #2: Compared to wait-list controls, intervention participants will report~     increased feelings of hopefulness.~      Hypothesis #3: Compared to wait-list controls, intervention participants will report~     enhanced coping ability.~      Hypothesis #4: Compared to wait-list controls, intervention participants will report~     enhanced recovery.~      Hypothesis #5: Compared to wait-list controls, intervention participants will report greater~     ability to advocate for themselves with health care providers.~      Hypothesis #6: Compared to wait-list controls, those in the BRIDGES education course will~     report increased knowledge of the causes and treatment of mental illness and recovery~     principles.~   "
134229|NCT01297972|"~     Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging~     results and may be an alternative to the treatment of immune-mediated severe acquired~     aplastic anemia.~   "
134230|NCT01297959|"~     This study is intended to determine the efficacy of topical application of E-101 Solution~     directly into the surgical incisional wound in the prevention of infection of superficial~     and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is~     being developed for direct application to a surgical incision.~   "
134231|NCT01297946|"~     Recent developments of continuous glucose sensors and insulin infusion pumps have motivated~     the research toward closed-loop strategies to regulate glucose levels in patients with type~     1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a~     computer-generated recommendation that relies on continuous glucose sensor readings. In this~     study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop~     strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII)~     therapy in regulating glucose levels during an evening exercise and on a night following an~     exercise in adults with type 1 diabetes.~   "
134232|NCT01297933|"~     A compassionate use protocol to provide Omegaven to pediatric patients with parenteral~     nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).~   "
134233|NCT01297920|"~     The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic~     suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual~     active components in subjects with open-angle glaucoma and/or ocular hypertension.~   "
134234|NCT01297907|"~     Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial~     hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two~     studies involving mainly adults.Our aim was to determine the frequency of bronchial~     hyperreactivity in pediatric patients followed and treated for Crohn disease.~      Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by~     spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO~     (FENO). The control group included patients evaluated for functional cough who had negative~     Methacholine Challenge Test (MCT).~   "
134235|NCT01297894|"~     In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to~     mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative~     bacterial including MDR A. baumannii In this study, we compare the clinical and~     microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A.~     baumannii infected patients~   "
134236|NCT01297881|"~     Pulmonary function tests including spirometry, lung volumes, measurements of resistance and~     diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests~     are an integral part of the diagnosis and treatment of lung diseases, but until now there is~     no clear evidence for the use of many of the pulmonary function tests because of a lack of~     adequate studies. The obscurity largely pertains to the conditions under which combinations~     of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all~     pulmonologists and the pneumology LOK/GLEM‟s, will investigate this matter.~   "
134237|NCT01297114|"~     This investigation is designed to study how the brain functions when it is performing~     explicit memory tasks, and furthermore how the brain systems supporting performance on these~     tests change as a function of aging. Implicit memory tasks may be distinguished from~     explicit memory tests in that explicit memory characterizes the directed or intentional~     recollection of previously learned information or events. In contrast, implicit (or~     nonconscious) memory is expressed in the facilitation of performance on some task or~     judgment on a stimulus owing to a prior presentation of that stimulus, without any necessary~     conscious awareness of the prior presentation. The investigators propose to use functional~     Magnetic resonance Imaging (fMRI) to measure brain activity during the performance of~     carefully designed explicit memory tasks. Comparison of brain activity during the different~     test conditions will provide information about the brain areas that are involved in~     mediating specific aspects of performance. Both older and younger individuals will be tested~     in order to understand age related changes in the brain activity. In order to examine the~     interactions between participants' differential levels of amyloid burden and their~     performance on cognitive tasks and fMRI neural activation, the investigators also propose~     PET imaging of older participants.~   "
134238|NCT01297101|"~     The aim of this study is to investigate the efficacy and safety of Tarceva versus~     combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage~     IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.~   "
134239|NCT01297088|"~     The study will be conducted as an open label, single-center, single dose and biodistribution~     study in patients with cancer or inflammation. 56 patients will be selected among the~     patients undergoing the screening examination conducted within 3 weeks before drug~     administration. Single dose of the study drug will be administrated in a dose of 300 MBq to~     these patients. The follow-up period contains the end-of-study telephone interview 5-8 days~     following the treatment. Key measurements are the PET/CT image acquisitions within a time~     frame of about 2 hours after the single injection of BAY86-9596.~   "
134242|NCT01297855|"~     In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa~     contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and~     Colistin.~      In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to~     receive Colistin alone and another group will receive Colistin plus Rifampicin.~   "
134243|NCT01297842|"~     Adult patients with ESBL-producing Gram negative infections are randomized to receive~     ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups~     are compared.~   "
134244|NCT01297829|"~     Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic,~     anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV~     antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate~     route for administration of ibuprofen when the oral route is not preferable. Recent studies~     have reported that Caldolor® decreases morphine use and pain at rest and with movement~     compared to patients not receiving this drug.~      The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30~     minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or~     umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within~     the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and~     7 days after surgery. The use of less postoperative narcotics has been associated with a~     faster return of normal bowel function and resumption of normal ambulatory status thus~     resulting in improved general well being for the patient.~   "
134245|NCT01297816|"~     This process appears as a incredible and progressive event that will not stop till~     reattachment of RPE and neurosensory retina happened .~      Process of degeneration begins from first hours of RD (Retinal Detachment) establishment~     Neuroprotection of photoreceptor following RD is a novel and debatable discussion~     encountered in recent years .~      How to stop this phenomena and neuroprotective agent role in this issue are a new interest~     of researcher.~      In the study the investigators are planning to perform a clinical trial to demonstrate the~     minocycline neuroprotective effect in a double blind design as this impact has been~     implicated previously in a animal study~   "
134246|NCT01297803|"~     Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results~     and better control of intraocular pressure complications such as corneal endothelial cell~     loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap~     dissection. Mitomycin_c application after sclera flap dissection probably increases corneal~     endothelial cell loss. This study compares Mitomycin_c application two methods: before and~     after sclera flap dissection with regard to success rate and complication. patients on base~     of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups(~     before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism,~     polymegathism and intraocular pressure before and one month, three months, six months after~     surgery will measured.~   "
134247|NCT01297790|"~     The sensitivity of a persons cough reflex can be measured by getting them to breath in~     (inhale) irritant chemicals. The purpose of this clinical research study is to test the~     sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if~     coughing responses are different between healthy people and people with respiratory problems~     that make them cough.~   "
134248|NCT01297777|"~     The aim of this study is to evaluate the efficacy in terms of clinical and biological~     response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking~     KIT mutations.~   "
134249|NCT01297764|"~     This study will evaluate the feasibility of combining four of the most active agents~     available for the treatment of multiple myeloma. Further the investigators will attempt to~     assess the activity of this combination.~   "
134250|NCT01297738|"~     Obesity and insulin resistance may be in part explained by an altered reward system with~     changes in the serotonin/dopamine system. These changes might be caused by changes in~     dietary habits, especially by an increased intake of liquid sugar and an increase in meal~     frequency. The investigators hypothesize that increasing meal frequency compared to~     increasing meal size and when consuming a hypercaloric high-sugar diet (HS) compared to a~     hypercaloric high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral~     serotonin and dopamine transporters and in a more prominent increase in insulin resistance.~     In addition, the investigators hypothesize that the changes in insulin sensitivity will be~     independent of changes in abdominal (visceral) and liver fat and that changes in insulin~     sensitivity due to the dietary manipulation will co-occur with changes in insulin signaling~     pathways in peripheral fat and muscle tissue.~   "
134251|NCT01297725|"~     The purpose of this study is to compare sharp and blunt fascial entry during caesarean~     section on the same patient. The study is performed on woman having cesarean section for the~     first time and who have not previously had lower abdominal surgery done. The following~     parameters are registered:~        1. The preferred side evaluated by the patient 3 months postoperatively.~        2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and~          1 and 3 months postoperatively.~        3. The rate and side of infection.~   "
134252|NCT01297712|"~     Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts~     to save costs include endoscopic assessment of polyps with regards to differential diagnoses~     between adenomas (which have to be removed) and hyperplastic polyps (could be left in place~     or removed and not examined histologically). Such a concept would only be feasible if~     endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates -~     between 80% and 95% - have been reported from reference centers with specific scientific~     interest. The investigators want to test whether these results a) can be reproduced in the~     private practice setting performing large-volume screening colonoscopies and b) whether~     latest generation endoscopes provide benefit in terms of better accuracy.~   "
134253|NCT01297699|"~     The purpose is to investigate tocilizumab administration in patients with moderately to~     severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with~     corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic~     alternative.~      The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment~     in order to provide a better alternative to surgery for this patients.~   "
134513|NCT01294228|"~     This is a multi-center, prospective, observational study of patients that are admitted to~     the intensive care unit (ICU). This study does not include any treatment or intervention and~     it is considered Nonsignificant Risk.~   "
134254|NCT01297686|"~     Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for~     those workers required to stand for long periods of time, and is typically associated with~     point tenderness at heel and arch of the foot. This clinical trial will investigate the~     effectiveness of an innovative multi-element exercise program versus the standard of care~     for plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined~     through questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy~     who must stand for prolonged periods of time (i.e. > 6 hours) during their workday will be~     invited to participate in this study. After ensuring eligibility, each subject will be~     randomly assigned to either the intervention group who will receive a multi-element exercise~     program, or the control group who will receive a cortisone injection followed by a~     stretching program for their calf-muscles (standard of care). The treatment length for both~     groups will be 12-weeks.~   "
134255|NCT01297673|"~     The purpose of this study is to investigate the incidence of reflux in patients with spinal~     cord injury in relation to the lesion level, duration of injury and bladder management~   "
134256|NCT01297660|"~     Most patients with spinal cord injury suffer from bladder dysfunction which may - especially~     in the long-term - impair renal function. Improved treatment during the last decades~     improved life expectancy and quality of life. This study evaluates the bladder function in~     the long-term after spinal cord injury.~   "
134257|NCT01297647|"~     The purpose of this study is to evaluate the incidence of urinary tract infection after~     urodynamic investigation and to identify the involved germs.~   "
134258|NCT01297634|"~     This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the~     botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the~     drug. A basal line control and After the application control will be made, and the~     investigators will evaluate the drug effects, based on clinical aspects, photographic~     registers and through electromyography exam (EMG).~      Considering the results of our investigation, the investigators may propose a pattern of~     application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.~   "
134259|NCT01297621|"~     This prospective controlled trial was designed to determine whether breast reduction may~     influence physical activity and sexuality of breast hypertrophy women.~   "
134260|NCT01297608|"~     This is a double blinded cross over study. Approximately 20 spinal cord injury patients will~     be participating in this 4 weeks study.The primary outcome is difference in fecal~     incontinence as recorded in diaries, between the treatment period and the treatment period.~   "
134261|NCT01297595|"~     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over~     single-dose study employing administration of two oral formulations of crizotinib (OLF and~     FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled~     to obtain at least 20 evaluable subjects who complete the study. Each subject will receive~     two treatments (A and B) with a washout period of at least 14 days between each treatment.~   "
134262|NCT01297582|"~     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950~     across ascending single doses in healthy adult male and female subjects. The secondary~     objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950~     by measuring plasma concentrations of ONO-6950, pulmonary function, and potential~     cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a~     meal upon the pharmacokinetic profile of ONO-6950.~   "
134263|NCT01297569|"~     This study is designed to explore a more individualized treatment regime based on~     achievement of disease stability to define a personal optimal treatment interval with~     ranibizumab in patients with visual impairment due to diabetic macular edema.~   "
134264|NCT01297556|"~     The purpose of this study is to determine if any specific patient characteristics lead to~     improved outcome of IBS treatment, when conventional treatment as well as Cognitive~     Behavioral Therapy is used in combination.~   "
134265|NCT01297543|"~     Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to~     accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in~     patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid~     leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this~     study, the safety, tolerability and activity of CLT-008 administered after standard of~     care cytarabine-based consolidation or induction/re-induction chemotherapy will be~     determined by monitoring for adverse reactions, infusion reactions, graft-versus host~     disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and~     complications.~   "
134266|NCT01297530|"~     This is the first study of this drug in human beings. Every patient will receive the drug,~     there is no placebo group. Patients with advanced tumors will be treated. Different groups~     of patients will receive different dosages to determine the safety and maximum tolerated~     dose (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the~     body, its biologic effects in the body, and changes in tumor size.~      BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this~     study it may be later given as a tablet which dissolves in the stomach.~      BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor~     continues to grow, if side effects occur which the patient can not tolerate or if the~     patients decides to exit treatment.~      The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and~     Germany). The study will have a part where doses are escalated in different groups of~     patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be~     followed by an extension part where patients are treated at the highest tolerable dose in~     groups of up to 25 patients. The extension part will be described in an amendment to the~     study protocol later. The number of subjects estimated for this study will depend on the~     number of groups enrolled. The starting dose will be 5 mg given orally as a tablet~     formulation.~   "
134267|NCT01297517|"~     The purpose of this study was to evaluate the efficacy and safety of a fixed combination of~     Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its~     individual active components in patients with open-angle glaucoma and/or ocular~     hypertension.~   "
134268|NCT01297504|"~     The study was designed to gather information regarding the use of palivizumab for the~     prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected~     countries within Latin America.~   "
134269|NCT01297491|"~     The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as~     measured by determining the progression free survival (PFS), in patients with pretreated~     metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120~     will be investigated in two groups of NSCLC patients according to the histology of the~     cancer: squamous and non-squamous.~   "
134270|NCT01297465|"~     This is a multicenter, multi-national, randomized, open-label comparative trial. After~     screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle.~     Down-regulation treatment will start within 2 months following the screening visit. The~     routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist~     treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will~     be performed just before randomization and start of recombinant human follicle-stimulating~     hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is~     negative, the subject will be randomly assigned to one of the two treatment arms of the~     trial:~        -  GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5~          followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until~          required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be~          adjusted from stimulation Day 6 (increased or decreased) based upon the subject's~          ovarian response and according to the center's standard practice.~        -  Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required~          r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or~          decreased) based upon the subject's ovarian response and according to the center's~          standard practice.~      Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular~     development will be monitored according to the center's standard practice by ultrasound (US)~     and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least~     one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm).~     After this, a single injection of r-hCG will be administered in order to induce final oocyte~     maturation.~      At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally~     under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days~     after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer~     (ET) and luteal support will be performed as per center's standard practice.~      A post-treatment safety visit will be performed for all subjects who received r-hCG~     (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from~     treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit~     will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection~     (excluding pregnancy testing).~   "
134271|NCT01297452|"~     The purpose of this study is to find out the good and bad effects that occur when BKM120 is~     added to standard chemotherapy with carboplatin and paclitaxel.~   "
134272|NCT01297439|"~     Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in~     addition to downward traction on the fetal head for delivery of the shoulders. Shoulder~     dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of~     deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications~     associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000~     deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury)~     and hematoma. The objective of this study was to evaluate the pushing maneuver, that is~     performed gently on the fetal head since the crowning of the head (appearance of the fetal~     scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip~     off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive~     maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give~     the shoulders time to enter the pelvic cavity. The pushing maneuver will be evaluated in~     comparison with either an expectative attitude or a suctioning of fetal nose and mouth.~   "
134273|NCT01297426|"~     Obesity does not respond to high circulating levels of the hormone leptin. This study is~     aiming at finding out why this happens and open new avenues for treatment of obesity.~   "
134274|NCT01297413|"~     The purpose of this study is to assess the safety and tolerability of allogeneic adult~     mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.~   "
134275|NCT01297400|"~     The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment~     of subjects with partial thickness burns.~   "
134276|NCT01297387|"~     This observational prospective study will evaluate, according o usual local clinical~     practice, feasibility of endoluminal revascularization in diabetic patients with type C and~     D lesions, according to TASC II Criteria.~      About 300 patients will be treated with usual revascularization procedure. Each patient will~     be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.~   "
134277|NCT01297374|"~     The purpose of this study is to compare the effect of three different non-pharmacological~     interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical~     activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the~     percentage of body fat and basal metabolism of children and Overweight and obesity in the~     metropolitan region of Porto Alegre (RS).~   "
134278|NCT01297361|"~     Vitamin B12 deficiency is more widespread in the population than has been assumed so far.~     Since a deficiency in this vitamin can lead to irreversible neurological damage, early~     diagnosis is essential. Vitamin B12 is synthesized exclusively in micro-organisms, and in~     humans it is an essential component in methyl group transfer and cell division. The vitamin~     is crucially involved in the proliferation, maturation, and regeneration of neural cells. In~     combination with folic acid, as an enzymatic essential cofactor in the metabolism of~     homocysteine, vitamin B12 maintains low homocysteine levels. The aim of the present study is~     to investigate the relationship between religious origin and age, and Vitamin B12 and Folic~     acid plasma levels in non Jewish population in Western Galilee. The investigators assumption~     is that the results of the study will contribute to early detection and treatment of Vitamin~     B12 and Folic acid deficiencies in order to prevent long term complications.~   "
134279|NCT01297348|"~     Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl~     estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or~     pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2~     hormones for as long as the drug is used. Lybrel was marketed in the US in July of 2007. The~     objective of this database case-control study is to estimate the risk of idiopathic VTE~     (deep vein thrombosis and pulmonary embolism) in current users of Lybrel (ethinyl estradiol~     20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing~     20μg of ethinyl estradiol.~   "
134280|NCT01297335|"~     The purpose of this study is to determine the acute efficacy of intrathecal clonidine to~     reduce blood pressure in hypertensive subjects with poor blood pressure control and describe~     its effects on cardiovascular function.~   "
134416|NCT01295489|"~     This research trial studies biomarkers in patients with previously untreated invasive~     ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor~     tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly~     into the abdominal cavity (intraperitoneal) may help doctors learn more about the effects of~     intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more~     about biomarkers related to cancer.~   "
134281|NCT01297322|"~     The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva~     VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis:~     The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA)~     results that are less than manual compression by a clinically meaningful and statistically~     significant margin. The rate of major access site-related complications with the Cardiva~     VASCADE™ VCS is non-inferior to the major complication rates of manual compression for~     sealing femoral arterial access sites.~   "
134282|NCT01297309|"~     This study is a long-term, open-label study using NPSP558 for the treatment of adult~     patients with Hypoparathyroidism.~   "
134283|NCT01297296|"~     The primary objective is to assess the longterm safety of the CardioKinetix Parachute~     Implant and Delivery System in the partitioning of the left ventricle in patients with heart~     failure due to ischemic heart disease.~   "
134284|NCT01297283|"~     The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta~     CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from~     the device programmer (PECG) or an external ECG machine.~      The purpose of the study is to obtain more data on leadless ECG to determine whether LECG~     during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if~     it can be used during remote follow-up evaluations.~   "
134285|NCT01297270|"~     The objective of this trial is to evaluate the efficacy and safety of two different~     treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to~     standard of care (SOC) with PegIFN/RBV alone.~   "
134286|NCT01297257|"~     The primary objective of the DELIVER Study is to assess the deliverability of the Resolute~     Integrity Stent as primary stent or as a secondary cross-over stent following delivery~     failure of another stent type in real world patients.~   "
134287|NCT01297244|"~     This is an open-label, single arm, multicenter study. Subjects will be stratified by~     histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be~     limited to ≤ 30% of the entire study population.~   "
134288|NCT01297231|"~     Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and~     decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These~     women also commonly have breast MRI to monitor for breast cancer. Some features of normal~     breast tissue visible on breast MRI change depending on patient hormonal status. It has been~     questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests~     this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could~     be done looking at whether breast MRI could tell us anything about whether tamoxifen is~     working.~      This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will~     also look at if other factors like taking anti-depressants or gene type have any effect.~   "
134289|NCT01297218|"~     The primary purpose of this study is to evaluate the safety and the tolerability of~     NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the~     maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study~     drug in patients with dementia of Alzheimer's type.~   "
134290|NCT01297205|"~     PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended~     to treat premature infants with bronchopulmonary dysplasia. This study is to assess the~     safety and the efficacy of this study drug.~   "
134291|NCT01297192|"~     This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of~     solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.~   "
134292|NCT01297179|"~     The objective of this study is to determine the effect of multiple doses of mirabegron on~     the pharmacokinetics of an oral contraceptive.~   "
134293|NCT01297166|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and~     calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the~     method developed by KJ Dumas and JR Scholtz.~   "
134294|NCT01297153|"~     The purpose of this study is to document the safety and efficacy of primary IOL implantation~     in children below 2 years of age undergoing congenital cataract surgery.~   "
134295|NCT01297140|"~     Alzheimer's disease is characterised by a loss of cognitive functions and behavioural~     problems as set out under the term Behavioural and psychological symptoms of dementia~     (BPSD). The impact of BPSD in everyday life has heavy consequences for the patient and~     their family. The precocity of incidence, the frequency and the intensity of the BPSD are~     associated with a rapid decline in cognitive functions, an alteration in the activities of~     daily living, and a decrease in the quality of life for both the patient and the helper, an~     increased risk of hospitalisation and of institutionalisation as well as an increase in the~     cost to the health system. A greater understanding of the risk factors for the occurence of~     the BPSD would better allow the detection of patients who are particularly at risk for BPSD,~     to anticipate the crisis situations by proposing early and adapted care, and to better~     target the medicinal therapies. Certain observational arguments or results of retrospective~     studies speak in favour of the role of the basic personality in the occurence of BPSD in~     Alzheimer's disease. The investigators propose to clarify this role through a prospective~     study.~   "
134296|NCT01297127|"~     This prospective observational study will evaluate predictors of response to Invirase~     (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be~     collected during 48 weeks of treatment.~   "
134297|NCT01297062|"~     Compare the effect of exenatide (therapeutic and supratherapeutic concentrations),~     moxifloxacin and placebo on the QT interval.~   "
134309|NCT01296906|"~     One of the nation's major health priorities, as outlined in Healthy People 2010, is to~     increase the proportion of children aged 19 to 35 months who have received all universally~     recommended vaccines. This study will compare two interventions for increasing immunization~     rates in this age group, one using well-studied primary care practice-based methods and the~     other using innovative technologies to increase immunization rates at the population-level.~     Results of this study will provide data that will be relevant nationally in guiding future~     investment of resources to increase up-to-date rates in young children prior to school~     entry.~      Hypothesis: Population-based approaches will be more effective than practice-based~     interventions at increasing immunizations among 19-35 month olds.~   "
134298|NCT01297049|"~     The overall objective of this pilot study is to develop a cost-effective treatment~     methodology delivered outside of traditional clinical setting, and based on modern~     technology for patients with diabetes type 2 also suffering from obesity. This study will~     investigate the feasibility of web based counselling and situational feedback through mobile~     supervising. The intention is to treat 10-15 patients. All participants will receive~     standard treatment delivered by their general practitioners. In addition the participants~     will fill in and send diaries to the supervisors each evening for 4 weeks reduced to a~     weekly frequency for the next two months period. The diary's schedule will be an evaluation~     of the day activities related to meals and food, medication management as well as the~     performed physical activities. The diary's schedule will also include blood glucose sample,~     and plans for the next day especially regarding physical activity. The participants will be~     able to view their own registrations on a web page. Daily/weekly situational feedback will~     be given to the participants within a cognitive behavioural framework to stimulate~     self-management. The primary outcome will be the HbA1c levels. Secondary outcomes will~     include evaluation of lifestyle outcomes such as physical activity levels and eating~     behaviour, and skills such as self-management of medication. In addition, the interventions~     effectiveness will examine mental health outcomes such as emotional distress and~     health-related quality of life.~   "
134299|NCT01297036|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly~     developed donepezil formulation with a conventional formulation in healthy subjects with a~     single dose, randomized, open-label, 2-sequence -2period crossover study.~   "
134300|NCT01297023|"~     The study was conducted to investigate the effect of vitamin d3 alone and in combination~     with calcium phosphate on bone metabolism and further physiological parameters in healthy~     subjects. It is postulated that calcium phosphate beneficially influences the bone specific~     action of vitamin d3.~   "
134301|NCT01297010|"~     The majority of pediatric surgery takes place in an outpatient basis. The occurrence of~     postoperative vomiting can lead to a delay in hospital discharge. However, the use of~     postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects~     and also raises the final costs of the surgical procedure. The Objective our study is~     Compare the incidence of postoperative vomiting between children who received dexamethasone,~     dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient~     surgery. This is a randomized, double blind, placebo-controlled study to comparing the use~     of dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting~     prophylaxis in children submitted to general anesthesia. Data analysis will be used is~     Fisher's exact test for the categorical variables and the Anova test for numerical variables~     as they presented Gaussian variation. The study used a significance level of 5%.~   "
134302|NCT01296997|"~     The study was conducted to investigate the effect of a calcium phosphate supplementation on~     the secretion of incretins.~   "
134303|NCT01296984|"~     The aim of the project is to evaluate the oncological and functional outcome of the more~     extensive perineal dissection - i.e the extra levator resection - in abdominoperineal~     resections in patients with rectal cancer.~      Hypothesis: Extra levator perineal resection reduces local recurrence three year~     postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4~     years postoperatively.~   "
134304|NCT01296971|"~     This open-label, non-comparative study will assess the safety and tolerability of~     individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon~     alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV)~     genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks.~     For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for~     16-48 weeks. Patients who had previously received standard or pegylated interferons but were~     non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for~     up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given~     to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week~     follow-up.~   "
134305|NCT01296958|"~     The purpose of this study is to determine whether screening and treatment of tapeworm~     carriers can decrease community transmission of Taenia solium parasitic infection.~   "
134306|NCT01296945|"~     Providing child nutrition information is a major goal of every pediatric well-child visit.~     Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is~     challenging and insufficient. It is because of this that some have looked for innovative~     ways to enhance the delivery of this information. One such way is the use of touch screen~     computer programs containing nutritional information. Several studies have documented the~     value of patients receiving health information in such a manner.~      Nonetheless, the use of this medium has not been well studied in Spanish-speaking care~     providers of young children. The investigators recently conducted a study that evaluated~     user's perception of the usability of such technology, finding that most users thought that~     the touchscreen was easy to use, despite their low computer confidence levels. The~     investigators also evaluated the impact of using nutrition modules on user's nutrition~     knowledge, finding that immediately after use; participant's nutrition knowledge was~     improved. I now propose to evaluate this technology further through a 4 armed randomized~     controlled trial. The goal here is to evaluate the longer term impact of the educational~     modules on nutrition knowledge and the impact, if any, of additional web access to the~     modules, on longer term knowledge. A secondary goal is to better understand nutritional~     habits in this population and perceptions of weight.~   "
134307|NCT01296932|"~     Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least~     two prior treatment regimens may be enrolled in this trial. The trial will examine whether~     monotherapy with BI 836826 is safe and tolerable at escalating dose levels.~   "
134308|NCT01296919|"~     Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that~     inflammation of the uncinate process is associated with decreased ventilation and drainage~     of the paranasal sinuses and consequently with the inflammatory process occuring in the~     sinuses.~   "
134373|NCT01296074|"~     To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the~     peripheral blood of valve disease patients undergoing cardiopulmonary bypass~     perioperatively.~   "
134310|NCT01296893|"~     Following chemotherapy, some breast cancer survivors report alterations in their ability to~     remember, concentrate, or think, which can have significant emotional, psychological, and~     economic impact on their lives. Survivors have also reported feeling frustrated by the~     response of the medical community, who either may not acknowledge their symptoms or have no~     treatment options to suggest. Exercise may be a promising treatment, as improvements in~     cognitive function with exercise have been demonstrated in older adults and other clinical~     populations.~      The investigators will recruit women who have completed chemotherapy for breast cancer~     (within the past 2 years) and report cognitive changes. Women will be randomly assigned to~     either a 24-week aerobic exercise intervention or delayed exercise control (offered the same~     exercise program following the study). At the start and end of the study the investigators~     will measure: i) performance on four standard neuropsychological tests that measure working~     memory, learning, and problem solving; ii) a questionnaire on cognitive function and its~     impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of~     the standard neuropsychological tests which provides information on how the brain is working~     during the tests.~      To knowledge of the investigators this is the first study to examine the effect of an~     exercise intervention on cognitive function in breast cancer survivors. In addition, the use~     of fMRI imaging is a new way to approach this research question, and may be more sensitive~     to change than traditional measures of cognitive function.~   "
134311|NCT01296880|"~     The purpose of this study is to determine the effect of lacosamide on mood and quality of~     life in people with epilepsy.~   "
134312|NCT01296867|"~     To study the postoperative results in myopic and hyperopic eyes treated with two different~     laser ablation algorithms (STD and F-CAT), both FDA approved.~   "
134313|NCT01296854|"~     The primary objective of this study is to measure and compare the number of exacerbations~     (moderate or severe) between the two groups of randomized patients with and without thermal~     treatment). An exacerbation is defined by an increase in symptoms which justifies a~     unscheduled medical action: increased daily treatment and / or use of corticosteroids, and /~     or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation~     reports or unscheduled visits.~   "
134314|NCT01296841|"~     The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease~     patients may be provided using a new computerized system over standard network - called~     Collaborative Imaging - with similar patient experience compared to a conventional clinic~     visit.~   "
134315|NCT01296828|"~     Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth~     breathing children.~      Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and~     10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used~     the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth~     breathing children.~   "
134316|NCT01296815|"~     Kaposi sarcoma remains the most common malignancy among persons with HIV.~      Lesions localized to the airway may cause bleeding, pain and dyspnea.~      New therapeutic approaches for local disease are needed.~      The purpose of this study is to compare the effectiveness of intralesional bevacizumab +~     HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with~     AIDS.~   "
134317|NCT01296802|"~     Illicit use of the psychostimulant Ecstasy (3,4-methylenedioxymethamphetamine, MDMA) is~     considered a major public health issue. In Switzerland, MDMA and congeners are - after~     cannabis and cocaine - number three in the ranking of the most popular illicit drugs.~     Worldwide, Ecstasy is estimated to be even the second most popular illicit drug, used by~     millions of regular users.~      On the basis of animal data, it is likely that MDMA at high or cumulative doses damages~     serotonin (5-HT) neurons in the human brain. However, because of a multitude of~     methodological problems and a limited number of studies conducted in human subjects, no firm~     conclusions can yet be established whether chronic MDMA exposure produces a long lasting~     5-HT deficiency syndrome, with consequent neuropsychiatric risks. To further address the~     putative neurotoxicity of MDMA in the human brain, we propose that novel functional assays~     of serotonergic neurotransmission may be useful to clarify this issue. We suggest that a~     5-HT challenge study using positron emission tomography (PET) in conjunction with the 5-HT~     releaser dexfenfluramine [(+)FEN] may test the functional integrity of the 5-HT system in~     the living human brain.~      Specifically, in a placebo-controlled study, the 5-HT release capacity of serotonergic~     neurons shall be investigated by assessing [18F]-altanserin binding to 5-HT2A receptors~     following (+)FEN challenge in former and continuing MDMA users, and age and sex-matched~     MDMA-naïve controls. (+)FEN is a potent serotonin releaser without relevant affinity for~     5-HT, dopamine (DA) or norepinephrine (NE) receptors, and devoid of acute adverse effects in~     man. This makes (+)FEN an ideal pharmacological probe to explore functional integrity of~     serotonin neurotransmission.~      A second aim of our investigation is to detect possible impairments of cognitive functions~     and to study their relationship to serotonin neurotransmission as indexed by PET. In the~     course of the neuroimaging study, the investigators therefore also measure cognitive (e.g.~     attention, visual and working memory, learning, executive function) and affective functions~     (e.g. anxiety, impulsivity), suspected to be altered due to chronic MDMA use. Using~     correlational analyses, the investigators aim to determine if circumscribed regions of~     altered 5-HT function are associated with specific impairments in cognitive and/or~     behavioural parameters.~      We hypothesize that (+)FEN-evoked 5-HT release will discernibly alter availability of 5-HT2A~     receptors to [18F]-altanserin, with a pattern revealing the spatially heterogeneous~     vulnerability of 5-HT innervations to MDMA. The investigators predict that [18F]-altanserin~     volume of distribution (DV) will decline following (+)FEN challenge to a lesser extent in~     current MDMA users compared to MDMA-naïve control subjects. On the basis of animal data and~     recent neuroimaging studies in humans, the investigators hypothesize that functional~     recovery in former MDMA users will be manifest by a normalization or overshoot of the 5-HT~     release capacity.~      Our methodology will allow us to quantitatively assess serotonergic functions in the living~     human brain. The novel combination of (+)FEN-induced release of 5-HT from intracellular~     storage vesicles and subsequent PET assessment of competitively altered [18F]-altanserin~     binding at postsynaptic 5-HT2A receptors will provide a more direct biological marker of in~     vivo serotonin function than has been hitherto available. By applying this new~     pharmacological challenge/PET neuroimaging approach to groups of current and former users of~     MDMA, the investigators shall be able to gain important new insight in the debated~     functional consequences of MDMA use, especially concerning the controversy about the~     reversibility of 5-HT changes following cessation of MDMA use. Successful completion of this~     project should have useful implications for public education and harm reduction with respect~     to MDMA use, and may also facilitate the development of possible treatment options for~     chronic MDMA users.~   "
134318|NCT01296789|"~     The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of~     septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment~     goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the~     duration on vasopressor treatment compared to a conventional protocol.~   "
134319|NCT01296776|"~     Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone~     via its acute and longitudinal effects on muscle mass and strength, the corresponding impact~     on bone density and falls in older adults has not been assessed yet. The investigators~     hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and~     significantly reduce fall rate and ratio in a cohort of frail elderly women.~   "
134320|NCT01296763|"~     Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or~     other defects in homologous repair will have cancers that respond to olaparib when given in~     combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).~   "
134321|NCT01296750|"~     A knee dislocation is an unusual and extremely serious injury and is defined as complete~     displacement of the tibia with respect to the femur, usually with disruption of 3 or more of~     the stabilizing ligaments. When the knee dislocates, there is often significant damage to~     the soft-tissues envelope surrounding the joint, including adjacent neurovascular~     structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event,~     with the potential to necessitate career change in athletes and laborers alike. Current~     evidence indicates that operative management for these injuries is more effective at~     returning patients to pre-morbid range of motion (ROM) and activity than conservative~     management. Post operative rehabilitation programs for these patients must balance the need~     for stability of their surgical repair and knee ROM and functionality. Experimental data~     suggests that post-operative immobilization offers greater protection of the surgical~     reconstruction, whereas immediate, aggressive physiotherapy may be more effective at~     preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical~     trial comparing early physiotherapy (day one post op) versus immobilization for three weeks~     then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all~     aspects except for progam initiation.~   "
134322|NCT01296737|"~     The purpose of this study is to validate the use of DSPECT camera for the performance of~     quantitative spect ventricular function imaging by comparison to a validated procedure~     performed on standard nuclear cameras.~   "
134403|NCT01295658|"~     The Cancer Support Community's (CSC) Research and Training Institute has created the Cancer~     Experience Registry: An Online Initiative to Change the Future of Cancer Care to identify~     and understand the emotional and social needs of cancer survivors. Armed with this~     knowledge, the investigators will raise awareness about and help develop programs to address~     the needs of cancer survivors. Anyone who has ever received a cancer diagnosis, whether~     recently diagnosed, in treatment, or years post-treatment can participate. Interested cancer~     survivors can register at www.cancerexperienceregistry.org~   "
134323|NCT01296724|"~     Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH)~     associated with a new organ failure. The occurrence of this syndrome is not well known in~     infants. Preterm birth is frequently associated with gastrointestinal complications,~     particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra~     abdominal pressure (IAP) increases and can participate in the occurrence of organ failures.~     Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis,~     could themselves be suffering from this syndrome. It would be interesting to make early~     diagnosis in order to optimize the management of these children. This requires reliable~     measurements methods and standards. Intravesical Pressure (IVP) is the most reliable~     validated indirect method to measure intra-abdominal pressure. In order to measure the IVP,~     the bladder must contain a minimum of liquid. However, using inappropriate volumes could~     give erroneous IAP readings. The optimal amount of saline to inject in older children,~     determined from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this~     volume appear extremely low (e.g. 0 8cc if taking a child to 800 g). The question that~     arises is whether this quantity is sufficient to obtain reliable and reproducible~     measurements of IVP in preterm and term.~   "
134324|NCT01296711|"~     The purpose of this study is to evaluate the long term safety and tolerability of CDP6038~     treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.~   "
134325|NCT01296698|"~     This study is to see if a new nicotine replacement therapy safely helps people to quit~     smoking if it is used the way it would be if it were sold at the pharmacy and used at home.~     Approximately 1500 subjects will be enrolled into the study. The study will require~     participants to use the treatment for 12 weeks and there will be a 14-week follow-up period.~     The study will be conducted in approximately 20 pharmacies across the United States.~      At the first visit to the pharmacy, participants will be asked some questions to see if they~     are eligible to participate. Participants will be asked to sign a consent form if they agree~     to participate. Participants will answer some more questions, and blow into a machine to~     measure their carbon monoxide (CO) levels to make sure they qualify for the trial.~     Participants will be asked to go to a nearby dentist who will look at their mouths.~     Participants will go back to the pharmacy and if they qualify, they will be given a supply~     of their assigned treatment. They will have an equal chance of receiving a treatment that~     has a drug in it or one that has no drug in it. They will be given a diary to keep track of~     how much of the treatment they use.~      Subjects will go to the pharmacy four more times to hand in their diaries and blow into a~     machine that will measure their CO levels. At the last visit, subjects will have their~     mouths examined by a dentist again to have their mouth checked.~      Subjects will receive four telephone calls during the study where they will be asked some~     questions.~      After the 12 week treatment period, subjects will receive two to three more telephone calls,~     where they will be asked to answer some questions. Participants may be asked to come back to~     the pharmacy two more times to blow into the carbon monoxide machine again.~   "
134326|NCT01296685|"~     The goal of the study is the evaluation of the air handling of a new type of oxygenator~     versus the standard model. The new type has an integrated arterial filter. The standard~     model has a non integrated arterial line filter. If the air handling is as effective/ better~     than in the standard model this can lead to reduction of cardiopulmonary bypass circuits~     with their initiation of systemic inflammatory response and improve cardiopulmonary bypass~     safety.~   "
134327|NCT01296672|"~     The investigators will propose a novel method to improve prostate cancer screening with PSA,~     using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic~     Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The~     investigators will also examine three additional promising tests that may further improve~     diagnosis of prostate cancer.~   "
134328|NCT01296659|"~     Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been~     tested in combination with the standard of care chemotherapy for sarcoma as this study will.~     We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well~     tolerated and to determine a Phase 2 dose.~   "
134329|NCT01296646|"~     Purpose: The proposed 2-year investigation will be the first double-blind,~     placebo-controlled trial examining the hedonic response to sweet taste (HRST) as a~     phenotypic predictor of naltrexone (NTX) response in alcohol dependence. HRST yields two~     primary phenotypes—Sweet Likers (SL) and Sweet Dislikers (SDL). Based on preliminary~     findings, HRST will be examined in conjunction with craving for alcohol to assess whether~     the two factors together provide a more robust predictor of NTX response. The identification~     of methods to predict naltrexone response in alcohol dependence is an important goal for~     alcohol treatment research. Currently naltrexone is not being used nearly as much as it~     should be, in part because clinicians do not believe it is very effective. The development~     of tools that would identify which patients are more likely to have a robust response to~     naltrexone should lead to increased use of the medication. This could help many patients who~     are not now having the opportunity of trying naltrexone.~      There are two principal Specific Aims for the study:~      Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial~     alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone.~      Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving~     predict % heavy drinking days (%HDD) during treatment with naltrexone.~   "
134330|NCT01296633|"~     The broad goal of this project is to improve knowledge of and adherence to medication~     regimens and health outcomes among adults with type 2 diabetes or other metabolic disorders.~     These patients have complex self-care needs, but limited literacy and cognitive skills to~     meet these needs. Medication error is widespread and costly, and often associated with~     inadequate patient knowledge about medication, especially among chronically ill adults with~     limited health literacy. Inadequate knowledge is often traced to limited communication with~     providers, in part because of barriers such as limited patient contact time and~     communication training, and lack of system-level support for consistent use of~     patient-centered strategies. There is a need to leverage information technology (IT) to~     provide system-based support for patient-centered communication. The investigators will~     evaluate an Electronic Medical Record (EMR)-based tool (the Medtable) to support~     provider/patient communication and improve medication knowledge, adherence, and health~     outcomes among chronically ill adults with complex medication regimens. A paper-based~     Medtable has been found to help older adults create accurate medication schedules in a~     simulated patient/provider communication task (Morrow et al., 2008). Benefits for patients~     should be enhanced if the Medtable is integrated with an EMR, giving providers ready access~     to relevant background information and current medication lists that patients can update, so~     providers can generate and tailor the Medtable for a diverse set of patients. This system~     provides an integrated approach to patient education about medications, from prescribing to~     counseling during office visits. As a result, patients would not only understand how to take~     their medications, but develop concrete plans for doing so. Specific aims of the project~     are: 1) Refine the Medtable prototype for use in an EMR environment. This includes~     developing protocols for generating patient-specific Medtables and educating providers to~     use them in medical encounters. 2) Evaluate the Medtable's impact on patient care processes~     and outcomes. The investigators will test the following hypothesis about communication~     processes: H1) Patients in the intervention condition will be more satisfied with~     communication about medication than patients in the usual care condition. The investigators~     will also test the following hypotheses about patient outcomes: Compared to usual care~     patients, patients receiving the Medtable intervention will: H2) know more about their~     medications; H3) adhere more accurately to their medication regimens; H4) more likely have~     blood glucose (glycosylated hemoglobin, HbA1c) levels in the target range. Aim 1 will be~     accomplished by interviewing physicians and their patients as the system is refined to~     ensure ease of using the system, and by collecting preliminary evidence that the Medtable~     improves patient/provider communication. After establishing initial feasibility and ensuring~     provider acceptance of the system, Aim 2 is addressed by a randomized trial at the general~     internal medicine clinics in Chicago and Peoria (IL), comparing patients who use the~     Medtable with their providers to those receiving usual care.~   "
134331|NCT01296620|"~     Post-operative administration of ulimorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection~   "
134332|NCT01296607|"~     Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem~     with a poor prognosis and the search for novel treatments remains an important area of~     research.~      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There~     has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in~     heart failure.~      In this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the~     onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 & 3 on~     forearm arterial blood flow healthy volunteers.~      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we~     will be able to focus on the local effects of urocortins on arterial blood flow in forearm~     vessels, without affecting this system in the body as a whole.~   "
134333|NCT01296594|"~     Poor adherence to antihypertensive medications is associated with morbidity, and data~     suggest that substance abuse may contribute to poor adherence. Contingency management (CM),~     an intervention highly efficacious for improving outcomes of substance abusers, shows~     promise in improving medication adherence in a handful of small trials. CM involves~     providing tangible reinforcement each time the behavior (medication ingestion) is exhibited.~     Thus far, studies evaluating CM for increasing medication adherence have utilized MEMS caps,~     but reinforcement of adherence via MEMS caps is done relatively infrequently and with delay,~     hindering its efficacy. A widely utilized technology that may be more appropriate for~     reinforcing medication adherence is cell phones, which can record the process of pill~     ingestion through video functions. As regular monitoring and feedback is important in the~     efficacy of CM, patients can be provided with daily messages regarding adherence and CM~     earnings. In this pilot study, we propose to randomize 40 hypertensive substance abusing~     patients with suboptimal adherence to antihypertensive medications to one of two 12-week~     treatment conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM.~     In the CM condition, patients will carry a cell phone and record and send in time- and~     date-stamped self videos of medication ingestion. These patients will receive congratulatory~     messages or reminders about adherence, and they will earn vouchers each time medication~     ingestion occurs at the appropriate time, along with bonuses for sustained adherence. We~     hypothesize that the CM condition will improve self report and pill count measurements of~     medication adherence and that it will result in decreased blood pressure. Results from this~     study may have widespread implications for the use of cell phones as a novel technology to~     improve medication adherence.~   "
134334|NCT01296581|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a~     single agent.~   "
134335|NCT01296568|"~     This is an open-label study being conducted to determine the metabolism and physiological~     disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or~     metastatic solid tumors.~      After a minimum 7-day washout period following the [14C]LY2603618 dose, patients will be~     allowed to continue to receive continued access to LY2603618 in combination with pemetrexed~     or gemcitabine as outpatients.~   "
134336|NCT01296555|"~     This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and~     pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During~     Stage 1, GDC-0032 will be administered every day orally (PO) and at escalating doses in~     participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will~     be administered alone or as combination therapy within indication-specific cohorts. In Phase~     II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be~     evaluated in post-menopausal female participants with locally advanced or metastatic human~     epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.~   "
134337|NCT01296542|"~     To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the~     conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3~     days of treatment.~   "
134338|NCT01296529|"~     Liver-related death is the leading cause of mortality in HIV-infected individuals with CD4+~     cell counts over 200, and hepatitis C virus (HCV) infection is the greatest risk for~     liver-related mortality in HIV-positive patients. Compared to HCV monoinfected individuals,~     patients with HIV and HCV coinfection experience accelerated progression of liver fibrosis,~     which can lead to higher incidence of cirrhosis, end stage liver disease (ESLD), and death.~     Changes in CD8+ T-cell activation, inflammatory cytokines, and serum markers of tissue~     injury may offer an immunologic platform to determine factors associated with progressive~     liver fibrosis in coinfected patients. In this cross-sectional study we will evaluate~     whether HIV and HCV coinfection patients with well-controlled HIV infection who have an~     undetectable viral load exhibit abnormal levels of inflammation and immune activation,~     potentially contributing to advanced liver fibrosis. Comparative groups include coinfected~     patients successfully treated for hepatitis C, or who have absence of hepatitis C viremia~     through spontaneous clearance, hepatitis C monoinfected patients, and HIV-positive patients~     with well-controlled HIV infection without hepatitis C. Liver fibrosis will be measured by~     non-invasive methods.~      The primary objectives of this study are:~        1. To determine if there are differences in markers of inflammation and immune activation~          in subsets of patients with HIV, hepatitis C, and HIV and hepatitis C coinfection.~        2. To assess the stage of liver fibrosis using non-invasive methods in subsets of patients~          with hepatitis C and HIV and hepatitis C coinfection and compare the degree of liver~          fibrosis with levels of inflammation and immune activation.~   "
134339|NCT01296516|"~     The overall objective of this pilot project is to test in 50 women with a history of~     gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month~     intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year~     after delivery.~   "
134340|NCT01296503|"~     This multicenter, prospective, randomized trial was designed to evaluate the role of~     thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma~     patients after a single autologous stem cell transplantation.~   "
134341|NCT01296490|"~     Physical exercise has many benefits, although it might also have negative impact on the~     body, which changes in accordance with training level, length of workout, age of subject and~     their fitness level. These outcomes are governed by complex biological processes, from which~     Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise~     activity. These substances harm muscle activity, and might cause other health related damage~     by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as~     Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is~     important to remember that ROS are essential to the investigators bodies as well, especially~     in gene regulation. Thus they influence proteins that are important for proper muscle~     function and the immune system.~      Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant~     enzymes. According to results that were published in the literature, no universal conclusion~     can be made regarding physical exercise effect on antioxidants activity. These~     contradictions might be attributed to the difference between the methods that were used, and~     their quality.~      Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle~     fibers as does not using the muscles for a long period of time (especially as a result of~     handicap). It is well known that physical exercise effect oxidative stress and antioxidant.~     Due to the doubts that rise from the literature, the investigators think that it is~     important to test physical fitness effect on oxidative stress biological markers, using~     various high quality methods, on the same population.~      The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat,~     who do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to~     exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour~     after the test (checking recovery).~   "
134404|NCT01295645|"~     The goal of this clinical research study is to learn if adding cidofovir to the standard of~     care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to~     standard of care alone. The safety of cidofovir will also be studied.~   "
134417|NCT01295476|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer. It may also help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in bone marrow samples from patients~     with T-cell acute lymphoblastic leukemia.~   "
134342|NCT01296477|"~     There is a mounting body of evidence suggesting that there is a large disparity between the~     development and the actual implementation of guideline-driven asthma care in primary and~     specialty care practices. To address this disparity, the American Academy of Allergy, Asthma~     & Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for~     clinicians who treat asthma patients called Asthma Specialist Tool to Help Manage Asthma~     and Improve Quality (Asthma-IQ). This study will examine whether the use of the Asthma IQ~     primary care tool will improve asthma care and asthma outcomes using a randomized trial of~     the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At~     the end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional~     year to determine if the patients managed by usual care in the first year improve when~     managed in conjunction with Asthma-IQ. The primary endpoint to determine if the use of the~     Asthma IQ tool will improve asthma patient outcomes is quarterly assessments of Asthma~     Control Test (ACT) scores via automated / electronic patient survey. The secondary endpoint~     is asthma exacerbations and there are a number of exploratory endpoints to further define~     the clinical utility of the primary care version of Asthma-IQ. This study will involve~     recruiting approximately 20 family medicine offices with approximately 20 patients each, to~     conduct this randomized, multiple time point intervention trial. The necessary total~     recruited patient sample size is 200 per group. The results of this study will help~     determine the utility of Web-based tools to help manage chronic diseases such as asthma.~   "
134343|NCT01296464|"~     The primary objective is to assess the effect of a single dose of two experimental~     levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment~     regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of~     duration of motor response after the first morning dose of levodopa. The secondary objective~     is to evaluate the safety of the L/C/E treatment regimens in patients with PD.~   "
134344|NCT01296451|"~     The study is aimed at assessing the safety of AdCh3NSmut and the new candidate vaccine~     MVA-NSmut when administered sequentially, or alone, to healthy volunteers and patients with~     hepatitis C virus infection The study also aims at assessing the cellular immune response~     generated by AdCh3NSmut and MVA-NSmut administered as mentioned above.~   "
134345|NCT01296438|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic~     (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin~     aspart.~   "
134346|NCT01296425|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment from hospitals in Austria and to assess the level of adherence of~     subjects receiving SAIZEN® via Easypod™.~   "
134347|NCT01296412|"~     This study is being done to compare the effectiveness and safety of two treatment paradigms~     (oral sitagliptin with or without glimepiride versus liraglutide with or without increased~     dosing) for the treatment of participants with Type 2 Diabetes that is not adequately~     controlled with metformin alone. The primary hypothesis postulated that the mean change from~     baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment~     is non-inferior to that of participants treated with a liraglutide-based~      treatment.~   "
134348|NCT01296399|"~     Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to~     Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis~     within previously deployed stent, is most often becoming clinically evident within the first~     6 to 12 months after the stent was deployed. Several risk factors are predictors for the~     development of in-stent restenosis. These can be generally calcified as either clinical,~     angiographic or procedural related factors. However it is difficult to estimate to what~     extent In stent re-stenosis is influenced by these various components.~      Drug eluting stent, as compared to bare metal stents, markedly reduced the incidence of~     angiographic in-stent restenosis. However this benefit must be weighed against a suggested~     increased risk of late and very late stent thrombosis, a catastrophic event often leading to~     myocardial infarction and death. Often in patients with existing risk factors for in-stent~     restenosis, drug eluting stents will be deployed even in cases where patency of a previously~     deployed bare metal stent have been demonstrated.~      Therefore the researchers sought to investigate whether in patients with previously deployed~     bare metal stent and no evidence of in-stent re-stenosis there will be a significant~     difference in the rates of in-stent between drug eluting stents and bare metal stents~     deployed within de-novo stenotic lesions.~   "
134349|NCT01296386|"~     An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84,~     A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects~   "
134350|NCT01296373|"~     RESTORE study:Thailand is a prospective observational study of HIV-1-infected patients who~     are either treatment naïve or who have been off anti-retroviral therapy for a ≥12 months,~     who have a CD4+ T cell count less than or equal to 350 cells/µL and who have been deemed by~     their treating physician that commencement of combination antiretroviral therapy (cART),~     which is expected to reduce plasma HIV RNA by ≥1log10 copies/mL, is necessary.~      The primary intent of this protocol is to prospectively establish a cohort of patients from~     whom clinical data and peripheral blood samples (serum, plasma and peripheral blood~     mononuclear cells) can be stored for substudies examining reconstitution of the immune~     system and its relationship to disease outcomes.~   "
134351|NCT01296360|"~     This is a randomized, open-label Phase 3 study including children aged >9 months to <17~     years and 7 months who have been vaccinated with IXIARO in study IC51-323.~   "
134405|NCT01295632|"~     This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752.~     In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug~     combinations will be found by giving sequentially higher doses of the study drugs. An~     expansion cohort of participants may be enrolled to confirm the MTD. New cohorts at other~     dose levels may be enrolled, depending on the rate of dose limiting toxicities (DLTs) in the~     planned cohorts. In Part B, an assessment of the efficacy of the drug combinations against~     selected advanced cancers will be made so that a recommended dose to be used in Phase 2~     studies (RPTD) can be found. As of 19 July 2012 the MK-0752 arms of the study were fully~     enrolled and closed to further recruitment. As of 30 November 2012, no additional~     participants with prostate cancer will be enrolled.~   "
134352|NCT01296347|"~     This study will test the null hypothesis that low-dose ketamine given peri-operatively will~     have no effect on the development of chronic post-surgical pain, in patients undergoing~     thoracotomy or video assisted thoracic surgery (VATS) procedures~      A double-blind, randomised placebo-controlled trial will be used to test the null~     hypothesis. Potential participants due to undergo either thoracotomy or video assisted~     thoracic surgery (VATS) will be identified by the collaborating thoracic surgeons in the~     out-patient department. Patients will be sent information about the study by post, prior to~     admission for surgery. If they are willing to participate, written consent will be sought on~     the ward preoperatively, where they will complete baseline measures of pain.~      Patients will be randomised to receive an intravenous infusion of placebo (saline) or~     ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and~     continuing for the first three postoperative days (96 hours in total). Prior to starting the~     infusion a loading dose of ketamine (0.1 mg per kg) will be administered.~   "
134353|NCT01296334|"~     Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain~     from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the~     present study we investigate primary and secondary hyperalgesia in healthy volunteers~     following an experimental first degree burn injury.~      The objectives are:~        -  to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and~          buprenorphine).~        -  to investigate if these effects are related to the volunteers individual pain~          sensitivity~   "
134354|NCT01296321|"~     The purpose of this study is to determine whether tailored internet-administrated CBT is a~     feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive~     symptoms.~   "
134355|NCT01296308|"~     Despite the long tradition of complementary and alternative medicine (CAM) therapies there~     are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study~     aims to investigate the influence of a two weeks integrative inpatient therapy on the~     quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment~     includes aspects of conventional and traditional European and Chinese medicine, mind-body~     medicine, physical therapy and lifestyle modification (nutrition advices, stress management~     and exercise training). The observational design intends four measurement points: tree~     months before (T0), directly before (T1), directly after treatment (T2) and three months~     follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was~     combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain~     intensity, locus of control, interpretation of illness, coping style, anxiety/depression,~     life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition~     a qualitative interview should give a view to patient perspective of therapy process.~   "
134356|NCT01296295|"~     The purpose of this study is to evaluate the effectiveness of regular reporting of~     spirometric results combined with smoking cessation advice on smoking quit rate in adult~     smokers in primary care.~      Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with~     smoking cessation advice will increase smoking quit rate.~      Expected outcome: increase of smoking cessation rate .~   "
134357|NCT01296282|"~     To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT~     pacemakers for patients with heart failure and external non-invasive measurement~   "
134358|NCT01296269|"~     The purpose of this study is to investigate the role of a one-time intranasal administration~     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation~     and altruism in a healthy population of student controls.~   "
134359|NCT01296256|"~     The purpose of this study is to determine whether Bendamustine in combination with~     Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT~     in patients with aggressive lymphoma.~   "
134360|NCT01296243|"~     Given the activity of docetaxel in patients with progressive, metastatic~     castration-resistant prostate cancer, this study is being undertaken to evaluate the~     activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and~     chemotherapy-exposed patients.~   "
134361|NCT01296230|"~     The purpose of this study is to determine if the pre-operative levels of sex-hormones can be~     used to identify the varicocele patients who can expect improvements in their semen~     parameters following varicocelectomy.~   "
134362|NCT01296217|"~     In this study the investigators want to determine if the detection of lymph node is~     applicable in prostatectomy by laparoscopy.~   "
134363|NCT01296204|"~     The first step of this protocol called step pre-treatment study the biodistribution and~     pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step~     therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing~     doses of iodine 131. At least 17 patients will be included for an estimated duration of 2~     years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side~     effects, medium and long terms will be analyzed. After determining the toxic dose limit,~     patients will be treated at the maximum tolerated dose, for a total of 15 patients at this~     level, which will measure the objective tumor response to treatment. These patients will be~     followed for 1 year after injection therapy.~      ÉcouterLire phonétiquement~   "
134364|NCT01296191|"~     The purpose of this study is to compare drug concentrations in aqueous humor following~     ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.~   "
134406|NCT01295619|"~     This is a prospective study to evaluate the performance and safety of a new medical device~     used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.~   "
134407|NCT01295606|"~     To document cefazolin disposition (concentration/time profile, protein binding, metabolism,~     renal elimination characteristics) and its covariates in neonates following intravenous~     administration of the drug at induction of anesthesia, prior to an invasive procedure~      To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed~   "
134418|NCT01295463|"~     RATIONALE: Learning about the amount of information on fertility and infertility by patients~     before they received treatment for cancer in a comprehensive cancer center may help doctors~     plan the best treatment.~      PURPOSE: This clinical trial is studying the amount of information on fertility and~     infertility received by patients before treatment of cancer in patients who have finished~     treatment.~   "
134365|NCT01296178|"~     Advances in the biological characterization of AML can now make a proper estimate of the~     risk of recurrence and likelihood of survival of different groups of patients according to~     the expression of different disease parameters. Karyotype, the molecular alterations~     affecting genes FLT3, NPM1 and CEBPA, minimal residual disease by flow cytometry and~     response to first induction cycle are variables that must be taken into consideration when~     planning the treatment of first line from a patient with AML.~      This breakthrough in the field of biology has not resulted yet in the development of new~     drugs really effective in the treatment of AML. Therefore, the core of the treatment~     continue to rely on the use of traditional chemotherapy combined or not with allogeneic~     hematopoietic stem cell. Both treatments differ in their antileukemic efficacy, higher in~     aloTPH, as well as their toxicity and procedure-related mortality, increased also in the~     aloTPH. These aspects should be added that most candidates aloTPH patients lack an HLA~     identical sibling donor forcing the search for alternative sources and hematopoietic stem~     cell donors. These transplants alternative, but are not committed to their antileukemic~     efficacy, it does have implied a greater toxicity. Therefore, the ultimate effectiveness of~     these procedures depends largely on the proper selection of candidates for the same.~      While there is broad agreement in terms of induction chemotherapy using a combination of~     cytarabine with anthracycline, the choice of chemotherapy regimen is controversial~     postremisión today. In the poor prognosis of itself involve the LMA, patients classified as~     favorable group are acceptable disease-free survival with consolidation schemes involving~     high-dose cytarabine. For other patients appear to be inappropriate to combine cytarabine~     with an anthracycline, at least one cycle of consolidation, and raise the option of~     allogeneic different depending on prognostic markers~   "
134366|NCT01296165|"~     It is not clear why multi-resistant E. coli (also known as ESBL-producing) have recently~     became such important causes of infections in patients living and residing in the community.~     A risk factor analysis study performed during 2004 and 2005 in Calgary had shown that the~     consumption of the same types of food or well water sources were not significant risk~     factors for community-associated infections due to these E. coli. However, a significant and~     unexpected risk factor among these Calgary patients was recent visits to certain high-risk~     areas such as the Indian subcontinent (India, Pakistan), Africa and the Middle East.~     Therefore it is possible that international travel to certain high-risk destinations might~     play, in part, a role in the spread of multi-resistant E. coli across different continents.~     This would happen via the acquisition of these bacteria in the rectums of returning~     travelers and the same organism would later cause an infection. However, the evidence that~     the spread and infections due to ESBL-producing E. coli are associated with international~     travel is circumstantial at best and the investigators would like to prove that this is~     indeed true.~      The basic idea of the study is to culture the stool of travelers for ESBL-producing E. coli~     before they leave for India, within seven days after their return to Canada and again after~     six months. The investigators can then establish which travelers are rectally colonized when~     visiting India and if these bacteria are still present six months after their return. A~     detailed questionnaire regarding the traveler's itinerary and behaviours in India will be~     completed on their return to Canada. The investigators will then compare the itinerary and~     behaviours of colonized travelers with those of non-colonized travelers and identify certain~     high-risk behaviours and places for acquiring ESBL-producing E. coli in India. The~     investigators will also determine if colonized travelers will later develop infections with~     the same ESBL-producing E. coli they acquired while visiting India.~   "
134367|NCT01296152|"~     This study was done to look at the level of Depo-Provera, an injectable birth control, in~     the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir~     [LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the~     amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and~     Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety~     of Depo-Provera and Kaletra when they are used together. In addition to what is stated~     above, this study also explored any effect of Depo-Provera on the immune system.~   "
134368|NCT01296139|"~     Background:~      - Ferumoxytol is an approved iron replacement therapy agent that has some potential for use~     as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes~     that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but~     excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for~     use as an imaging agent, researchers are interested in testing its effectiveness as a~     contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of~     individuals with prostate cancer.~      Objectives:~      - To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals~     who are scheduled to have prostate removal surgery to treat prostate cancer.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and are~     scheduled to have surgery to remove the prostate and surrounding lymph nodes.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and tumor imaging studies.~        -  Participants will have a magnetic resonance imaging (MRI) scan to provide baseline~          images for the study.~        -  Participants will receive an injection of Ferumoxytol and will return for another MRI~          scan on the following day (around 24 hours later).~        -  Some participants may have a third MRI scan 48 hours after the initial injection of~          Ferumoxytol. This third MRI scan is optional and not required by the study.~        -  Although the scanning and followup portion of the study will last only a few days,~          participants will be considered to be enrolled on the study until after the prostate~          removal surgery.~   "
134369|NCT01296126|"~     Background:~      - Studies have shown that some people develop post-traumatic stress disorder (PTSD) after~     being exposed to the trauma of military combat. They may have repeated thoughts, images, and~     dreams of the trauma; feel detached from others; have difficulty sleeping and concentrating;~     or be easily startled. Some studies have also shown that after having a blow or blast to the~     head, some people may develop post-concussive syndrome (PCS), which may include symptoms~     such as headaches, difficulty concentrating, and feeling moody or irritable. Researchers are~     interested in using magnetic resonance imaging (MRI) to study combat veterans from Operation~     Iraqi Freedom or Operation Enduring Freedom in order to evaluate possible changes in the~     brain that may be attributed to PTSD or PCS.~      Objectives:~      - To evaluate changes in brain function in recent combat veterans that may be related to~     post-traumatic stress disorder or post-concussive syndrome.~      Eligibility:~      - Combat veterans of Operation Iraqi Freedom/Operation Enduring Freedom who are enrolled in~     Walter Reed Army Medical Center protocol 351030, have returned within the last 6 weeks from~     a deployment in Iraq or Afghanistan that lasted at least 3 months, and are able to have~     magnetic resonance imaging scans.~      Design:~        -  This study involves between 1 and 4 outpatient visits to the NIH Clinical Center over~          the course of 1 year. The second, third, and fourth visits will occur 3, 6, and 12~          months after the first visit.~        -  At the first visit, participants will have a baseline MRI scan, followed by a~          functional MRI (fMRI) scan to see what parts of the brain are used while performing~          simple tasks and responding to images. Participants will complete questionnaires after~          the scan to report on their experiences during the MRI scan.~        -  For the remaining three study visits, participants will have further MRI and fMRI scans~          and will complete additional questionnaires. Participation is complete after the~          12-month study visit, or following a diagnosis of PTSD, major depression, or PCS at any~          time during the study.~        -  No treatment will be provided as part of this protocol.~   "
134370|NCT01296113|"~     This is a phase II, multicenter, non-randomized, open-label study evaluating the combination~     of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.~   "
134371|NCT01296100|"~     The main aim of this study is to investigate to what extent it is possible to reach normal~     glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early~     lifestyle interventions in people at high risk of type 2 diabetes compared with those who~     receive standard therapy (usual care) only.~      The project will show the effect of these interventions for the first time in people of low~     socio-economic levels living in a Caribbean environment.~   "
134372|NCT01296087|"~     This study is designed to determine whether TC-6987 improves respiratory function in~     subjects with asthma by reducing airway hyper-responsiveness and inflammation.~   "
134374|NCT01296061|"~     Primary Hypotheses:~        1. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have more deaths than patients who discontinue these~          drugs~        2. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have more hospitalizations for sepsis than patients~          who discontinue these drugs~        3. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have fewer rejection events than patients who~          discontinue these drugs~      Secondary Hypotheses:~        1. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will~          have fewer deaths than those who retain the failed kidney transplant~        2. Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will~          have fewer hospitalizations for sepsis than those who retain the failed kidney~          transplant~        3. Among patients who retain the failed kidney transplant, those who continue~          immunosuppressant medication will have lower levels of allosensitization (anti-HLA~          antibodies) than those who discontinue these drugs~        4. Patients who undergo elective nephrectomy will have higher levels of allosensitization~          (anti-HLA antibodies) than patients who retain the failed kidney transplant~   "
134375|NCT01296048|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.~        4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).~        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.~   "
134376|NCT01296035|"~     This is a study to find out if the study drug, panitumumab, when given with gemcitabine~     works in treating ovarian cancer and to find out what side effects occur when they are given~     together.~   "
134377|NCT01296022|"~     This randomized controlled trial will outline the advantages and disadvantages of the~     subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.~   "
134378|NCT01296009|"~     To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation~     in the patients who have underwent in vitro fertilization and embryo transfer, the~     investigators compare the pregnancy rate in traditional Chinese medicine group and control~     group. The hypothesis is that pregnancy rate in traditional Chinese medicine group is higher~     than the control group.~   "
134379|NCT01295970|"~     Usually the treatment of a single brain metastasis is surgery or Stereotactic Radiosurgery~     (SRS). Surgery involves resection of the brain tumor by means of an operation, whereas SRS~     is treatment consisting of highly focused radiation doses to the tumor. These two treatment~     modalities are both widely used, well established, and proven to improve survival, but so~     far, no study has been done to directly compare the efficacy of one over the other. Neither~     treatment in itself is considered to be experimental and both have been shown to provide~     benefits to patients with metastatic brain tumors. The aim of this study is to determine~     which two modalities are better for local control and improving quality of life.~      Patients who consent to this study will be randomized to either receive surgery or~     Radiosurgery in the treatment of single brain metastases. The study seeks to recruit 12~     patient to each group. Patients will be in this study for up to five years from the time of~     the treatment finished. This will include follow-up visits at 4 weeks after the procedure~     and then every 3 months after the procedure up to 5 years.~   "
134380|NCT01295957|"~     The effectiveness of reminiscence for dementia has been claimed as an effective tool, but~     scientific validation and systematic assessment of this method is needed. Materials and~     Methods: A randomized controlled trial (RCT) was conducted to search whether a reminiscence~     program is associated with improvement of quality of life of demented long term care~     residents. The trial had three arms: interventional, comparison and control. The~     reminiscence program was modeled within a life-story approach, while comparison group~     received informal counseling to control for changes in quality of life resulting from social~     contacts. The Social Engagement Scale (SES) and Self-rated Quality of Life Index (SRQoL)~     were the outcome measures. The results were examined at baseline (T0), twelve weeks (T1),~     and 6 months (T2) after intervention. The sample had 135 subjects [intervention group~     (N=45), comparison group (N=45) and control group (N=45)].~   "
134381|NCT01295944|"~     The goal of this clinical research study is to learn if the combination of bevacizumab and~     carboplatin can help to control recurrent pendymoma. The safety of this drug combination~     will also be studied....~   "
134382|NCT01295931|"~     Objectives:~        1. To determine the feasibility of using microdose amounts of near-infrared (NIR)~          fluorescent contrast agent to image tumor-draining and contralateral lymphatics in~          melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion~          lymph node dissection (axillary or inguinofemoral)~        2. To determine the feasibility of using nonradioactive optical imaging techniques with~          indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic~          architecture and function by correlating the observed lymphatic structure and function~          with tumor and nodal status as determined from standard-of-care immunohistochemical~          evaluation.~   "
134383|NCT01295918|"~     The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus~     reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile~     infections in children and adolescents.~   "
134384|NCT01295905|"~     The purpose of this study is to evaluate the performance of an investigational daily~     disposable contact lens.~   "
134385|NCT01295892|"~     This study aims to evaluate the chronic effects of estrogen on microcirculation,~     inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in~     postmenopausal obese women after three months of follow-up intervention.~   "
134415|NCT01295502|"~     This phase I trial studies the side effects and the best dose of paclitaxel and carboplatin~     after cisplatin and radiation therapy in treating patients with stage IB-IVA cervical~     cancer. Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells. Giving paclitaxel and carboplatin after cisplatin and radiation~     therapy may kill more tumor cells.~   "
134386|NCT01295879|"~     Vitamin D plays a critical role in maintaining bone health, as well as preventing~     cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D~     deficiency is very common in the United States and worldwide, and is now being increasingly~     recognized and treated. One group in which vitamin D deficiency may be particularly~     important is patients who have had kidney stones. These patients frequently have elevated~     levels of calcium in their urine, which is a common and important risk factor for calcium~     containing kidney stones. Because vitamin D increases absorption of calcium into the blood~     by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients~     with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the~     urine. They are concerned about the possible risk of increasing the amount of calcium in the~     urine (and thereby increasing the risk of calcium stones occurring again). However, studies~     in patients without kidney stones, as well as studies in patients with high calcium levels~     in the urine, have demonstrated that giving vitamin D is effective and safe and does not~     increase calcium in the urine. Therefore, the investigators will study the effects of giving~     vitamin D on the amount of calcium in the urine in patients with a history of kidney stones~     and elevated calcium in the urine. The investigators will evaluate the safety of giving~     vitamin D to this particular group of patients.~   "
134387|NCT01295866|"~     Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of~     nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists~     comparing nNO with established, larger accepted reference standard for chronic~     rhinosinusitis (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal~     inflammatory diseases has not been reported. The aim of our study was to determine the value~     of nNO in patients with chronic nasal inflammation, and to assess the relationship between~     nNO and atopic status in these patients. A total of 131 randomized patients suffering form~     chronic nonallergic nasal inflammation and 20 healthy volunteers were finally recruited. nNO~     was measured by NIOX devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal~     symptoms evaluation were used in the different diagnosis of chronic rhinitis (CR), CRS~     without nasal polyps (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was~     confirmed by skin prick test and serum IgE levels. Blood eosinophils were evaluated~     simultaneously. Relationships among nNO, various atopic characteristics and chronic nasal~     inflammation were evaluated.~   "
134388|NCT01295853|"~     T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative~     compensatory hyperhydrosis~   "
134389|NCT01295840|"~     The purpose of this Clinical Trial is to determine the percentage of patients whose~     hemodynamic response improves with the different configurations offered by the new Quartet®~     left ventricular lead, as a result of its four electrodes, with respect to the~     configurations offered by a standard bipolar lead.~      Furthermore, the optimal stimulation configuration will be determined from a comparison with~     traditional configurations.~   "
134390|NCT01295827|"~     This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab~     (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2~     dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of~     any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety,~     tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and~     compare every 2 week to every 3 week dosing. Part C of the study will explore the safety,~     tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma~     (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and~     high doses of study drug identified in Parts A and B in participants with advanced or~     metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of~     study drug in combination with standard chemotherapy in participants with locally advanced~     or metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive~     and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1)~     gene expression. In Parts D and F and some of Part B participants will be randomized to one~     dose level. The primary hypotheses are the following: that pembrolizumab has acceptable~     safety and tolerability; and that pembrolizumab shows a clinically meaningful response rate~     (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or~     not), and a clinically meaningful RR in participants with NSCLC, especially a clinically~     meaningful RR in those participants with either cancer, whose tumors express PD-L1.~   "
134391|NCT01295814|"~     The purpose of this study is to evaluate an investigational treatment for interstitial~     cystitis. Interstitial cystitis is a chronic bladder disease that includes the following~     symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and~     bladder discomfort relieved by voiding.~      Presently, there is no cure for interstitial cystitis. The response to current treatments is~     poor. Patients with interstitial cystitis have a poorer quality of life. The cause of~     interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for~     improving the symptoms of patients with interstitial cystitis. Humira® is an injectable~     anti-inflammatory medication that has been available for use since December 31, 2002.~     Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis,~     ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to~     interstitial cystitis. This study will evaluate an investigational use of Humira® for the~     treatment of interstitial cystitis.~   "
134392|NCT01295801|"~     Linezolid is the first approved synthetic oxazolidinone that is active against~     multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid~     is widely used in clinical treatment. However, the side effects of linezolid commonly lead~     to anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used.~     The investigators have found that Vitamin B6 application, as a preventive, auxiliary~     therapy, can relieve anemia and thrombocytopenia. The present study was designed to verify~     the effects of Vitamin B6 in the prevention of linezolid-associated cytopenias and~     investigate its mechanism.~   "
134393|NCT01295788|"~     The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be~     more effective if introduced in children and adolescents with established diabetes at the~     same time as they are starting pump therapy. This randomized controlled trial will compare~     the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and~     adolescents with type 1 diabetes who are starting insulin pump therapy.~   "
134394|NCT01295775|"~     The aim of this phase 2 controlled placebo study is to assess the effectiveness of~     Sulodexide in the treatment of non proliferative (background) retinopathy in patients with~     Type 1 and Type 2 Diabetes Mellitus.~      This is a multicentre, double-blind, randomised study involving patients affected by non~     proliferative (background) diabetic mild to moderate retinopathy.~      This study will involve 130 patients (65 for each group). At baseline visit (T0), the~     Investigator will grade the ocular lesions due to diabetic retinopathy according to color~     fundus photographs and the fluorescein angiography examination. He will subsequently send~     the negatives of photographs and the images -or negatives when available- of fluorescein~     angiography to an off-site Assessor -unaware of the Investigator assessment- nominated to~     confirm the quality of the images and the grade of the lesions. After positive assessment of~     the Investigator, at T0 the eligible patient will be blindly allocated to one of the 2~     treatment groups according to a computer-generated randomisation list provided by the~     Sponsor.~      The following treatments will be administered for 360 days:~      A (SULODEXIDE GROUP): 50 mg a day by oral route;~      B (PLACEBO GROUP): Sulodexide placebo at the same schedule and for the same lengths of time~     as group A.~      Before breaking the randomisation code at the end of the study, an independent off site~     assessor will evaluate the photographs according to the Airlie House Classification and~     following modification by Early treatment Diabetic Retinopathy Study (ETDRS) and fluorescein~     angiography according to ETDRS.~   "
134395|NCT01295762|"~     Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood.~     About 50% of the cases present at diagnosis with factors of bad prognosis. During the last~     two decades, despite increased therapeutic intensity during induction and consolidation of~     high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in~     between 30 to 40% depending on studies.~      Besides strategies of high-dose chemotherapy followed by autologous transplantation of~     hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will~     become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or~     molecules obtained such gains of survival ever before.~      Studying the immune system of children with neuroblastoma at diagnosis and during their~     treatment will help us to determine when we should test active or passive immunotherapy~     strategies. Moreover, this study would allow us to specify the cause of tumor immune~     tolerance in neuroblastoma, on which we have few data in comparison to adult tumors.~      This will be a multicentric, pilot, prospective, open, study that will not require unusual~     diagnostic interventions. This study will be transversal (all neuroblastoma stages included)~     in order to determine comparative criteria between low and high risk neuroblastoma. It will~     also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify~     evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy.~      Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis,~     and during the treatment of children diagnosed for neuroblastoma (up to 3 time points).~     These types of samples are routinely done during conventional neuroblastoma treatment.~   "
134396|NCT01295749|"~     International recommendations stress on the importance of no flow time reduction in cardiac~     arrest management. In fact, no flow time is an independent factor of morbidity and~     mortality.~      In France, cardiac arrests are treated by first responders (including emergency nurses)~     before the arrival of a mobile intensive care unit. Those first responders use~     bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression~     / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest~     ventilation. The purpose of our study is to compare the no flow time between two strategies~     of out of hospital cardiac arrest management by first responders: conventional CPR with~     bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.~   "
134397|NCT01295736|"~     Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma~     (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many~     patients and effective therapy remains elusive. In the present study, the investigators~     propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind~     control study in SSc patients.~   "
134398|NCT01295723|"~     The purpose of this research study is to find out the effects (good and bad) of adding a~     dose of radiation to the area of the cancer during surgery to whole breast radiation therapy~     (WBRT) after surgery. IOERT is the application of electron radiation directly to the~     residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used~     to treat patients who have cancer in the breast covering the entire breast tissue. Both~     immediate and long-term effects will be measured.~      For patients with certain types of breast cancer, one standard treatment is removal of the~     area of cancer and a small amount of normal tissue around it followed by breast radiation.~     The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by~     5-8 daily radiation treatments at the site where the lump was removed called a boost.~     During this study, the single dose of electron irradiation (IOERT) given at the surgical~     site during the operation will replace the usual 5-8 days of localized radiation and the~     whole breast radiation will last 3 weeks.~   "
134399|NCT01295710|"~     The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to~     standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe~     chronic GVHD-free survival.~   "
134400|NCT01295697|"~     The goal of this clinical research study is to find the highest tolerable dose of EZN-2208~     that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety~     of the study drug and its effect on the disease will also be studied.~   "
134401|NCT01295684|"~     Previous studies have shown that consumption of a low calorie cranberry beverage imparts a~     favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men.~     However, these studies were not well controlled. Thus, it is important to confirm these~     effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify~     the cardioprotective effects of cranberries by conducting a dietary intervention trial with~     healthy subjects in a controlled environment.~   "
134402|NCT01295671|"~     The overall aim of the study is to compare the effects of three types of beverages -~     sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on~     cardiovascular disease (CVD) risk factors and body weight among young adults.~   "
134408|NCT01295593|"~     Rationale New chemotherapeutic agents are needed in relapsing B-Cell Chronic Lymphocytic~     Leukemia (B-CLL) to overcome resistance of CLL cells. Valproic acid (VPA) is an inhibitor of~     histone deacetylase (HDAC) used as an anticonvulsant and mood-stabilizing drug for decades.~     VPA mediates apoptosis in CLL cells through caspase activation. VPA shows toxicity toward~     CLL cells displaying alterations in the p53 pathway. The combination of VPA with fludarabine~     or 2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell~     viability, and significant increase in apoptosis. The highest index of synergism is observed~     between VPA and CdA, a purine nucleoside analog active in B-CLL.~      Study design Overall, the study will be proposed to previously treated patients with~     advanced B-CLL, who are not eligible for aggressive approaches, and who exhibit progressive~     disease. A total of 33 patients will be included. Estimated enrolment time is 2 years.~        -  First part: It is planned to start therapy with single VPA during 2 months, targeting~          plasma levels that have been reported to be active in vitro toward CLL cells (but that~          do not exceed therapeutic levels in seizure prevention), and in parallel, to verify~          whether cellular targets of VPA have been actually inhibited in leukemic B-lymphocytes.~        -  Second part: After the VPA preloading period (2 months), patients will be evaluated to~          receive CdA. CdA will be given at 5.6 mg/m²/day intravenously during 3 days, a~          reduced-dose schedule which is less toxic - at no obvious cost of loss of efficacy - as~          compared to the standard dosage of 5 days. CdA was chosen because it displays the~          highest level of in vitro synergism with VPA. Four monthly courses of CdA will be~          given. Patients will then be evaluated. VPA will be stopped at the time of response~          evaluation (scheduled 28 days after the last course of CdA).~   "
134409|NCT01295580|"~     The purpose of this study is to determine the comparative safety and efficacy of knee~     intra-articular injection of hyaluronic acid obtained from two different sources in the~     treatment of knee osteoarthritis.~   "
134410|NCT01295567|"~     Rationale:~      Due to western lifestyle human coronary arteries are prone to develop atherosclerotic~     plaques. Hence the heart is an important target organ for atherothrombotic complications:~     myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate~     symptoms and decrease mortality in these patients, myocardial revascularisation is~     recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe~     atherosclerotic disease of all three coronary arteries or the left main stem coronary~     artery. Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly~     accountable for complications that occur after CABG (e.g. death, myocardial infarction,~     arrhythmias, stroke, or renal complications). Dipyridamole has been shown to reduce ischemia~     reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent~     cardiovascular death or event in secondary prevention after cerebrovascular disease. The~     investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac~     tissue tolerance against ischemia and reperfusion injury due to CABG. The investigators~     expect lower troponin-I release in patients who were pretreated with dipyridamole.~      Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity~     (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with~     dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and~     duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole~     pretreatment on renal injury and post-ischemic recovery of contractile function (measured~     ex-vivo).~      Hypothesis:~      The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac~     tissue tolerance against ischemia and reperfusion injury. The investigators expect lower~     HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the~     investigators expect the incidence of arrhythmias, need for prolonged inotropic support~     (longer than 24 hours postoperative) to be decreased in pretreated patients.~   "
134411|NCT01295554|"~     Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the~     diagnosis and follow-up of peripheral arterial disease.~      In clinical routine, the acquisition uses intravenous injection of a Gadolinium based~     contrast agent (gadolinium chelates).~      Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients,~     elderly patients and\or patients with chronic renal insufficiency presenting a~     contraindication to CT angiography using iodized contrast agent injection.~      However, the increase in nephrogenic systematic fibrosis clinical cases, which would be~     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has~     restricted the use of CE-MRA. More than 500 cases were described to date in the world.~      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal~     insufficiency and its mortality around 30 %.~      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast~     agents (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate~     Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration~     rate is lower than 30 ml/mn.~      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide~     complete and non-invasive investigation of the peripheral vasculature, from the abdominal~     aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with~     no side effects.~      Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality~     images and good signal to noise ratio for peripheral vasculature analysis.~      Besides, the acquisition can be repeated if required as it does not require any contrast~     injection.~      The main objective is to evaluate the quality of the NCE images obtained for every~     investigated station from the abdominal aorta to the calf.~      The secondary objective is to compare the diagnostic performances of NCE images with those~     of CE MRA.~      The third objective is to estimate the contribution of automated and dedicated~     post-processing tools in optimizing the diagnostic quality of the images.~   "
134412|NCT01295541|"~     The current study is proposed to assess the frequency and type of progressive mobility~     procedures currently performed in the CVICU The study will evaluate the type and frequency~     of progressive mobility orders, whether or not progressive mobility steps are being taken by~     the nursing teams, define what steps patients are receiving, and record time to first weight~     bearing. Other outcome measures will be the days of required mechanical ventilation, and~     current ICU length of stay and cost to treat.~   "
134413|NCT01295528|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the function of device.~        2. Test methods and procedures: Performance test in two positions: Seated and Supine.~        3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.~        4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.~        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.~        6. Statistical methodology used: Description of statistical methods.~        7. Result: Meet the requirements of SP10.~   "
134414|NCT01295515|"~     Background:~        -  Antiretroviral therapy (ART) has been able to improve the lifespan of individuals~          infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous~          treatment that has substantial consequences on quality of life. ART suppresses HIV-1~          virus levels below the limits of detection in current tests, but does not completely~          eradicate the virus from the blood. Recent research is attempting to determine whether~          this persistent infection stems from a low-level infection where new cells are~          continually infected with HIV, or from cells that live for a long time after infection.~          ART is very active against the virus in new cells, but has no effect on long-lived~          cells that are already infected with HIV-1 at the start of ART. As a result, new~          strategies may be necessary to reduce or eradicate these 'reservoir' cells.~        -  Interferon is a natural substance made by the body to combat virus infections, but can~          also be made as an injectable drug known as PEGINTRON. PEGINTRON injections have been~          approved to treat hepatitis C infection, including in patients with HIV infection.~          Earlier studies of HIV-infected individuals who were not on any ART showed that~          interferon reduced the level of HIV in the blood. Researchers are interested in~          determining whether PEGINTRON therapy will also reduce the residual low levels of HIV~          in patients who are already taking ART.~      Objectives:~      - To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants~     currently undergoing antiretroviral therapy.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with HIV, are currently~     undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not~     detectable by current commercial tests for at least 12 months before the start of the study.~      Design:~        -  This study will involve separate screening and treatment processes.~        -  Participants will be screened with a physical examination and medical history,~          including blood and urine samples. The screening analysis to determine study~          eligibility will take several weeks. Participants will have apheresis to provide~          sufficient numbers of blood cells for evaluation by the study researchers.~        -  Eligible participants will begin a 4-week course of PEGINTRON injections using the~          standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C.~          Participants will have weekly injections and have frequent blood tests to measure HIV~          virus levels.~        -  Participants who experience problems in maintaining safe numbers of white blood cells~          during the study may receive injections of filgrastim to increase their white blood~          cell count.~        -  After the 4 weeks of treatment, participants will return for additional blood tests on~          study days 28, 35, 42, 49, 56, and 84, and Weeks 16, 24, 36, and 48 (i.e., through the~          end of 1 year after the start of the study).~   "
134419|NCT01295450|"~     The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC~     compared to vitamin complex, in the treatment of lack of appetite and prevention of~     deficiency of B and C vitamins.~   "
134421|NCT01295424|"~     Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas~     of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system~     until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac~     arrest primary survivors admitted to all Finnish ICUs.~   "
134422|NCT01295411|"~     The aim of the investigators analysis is to identify the neural correlates of quality of~     life scores in schizophrenia. For this, the investigators will constitute group of patients~     according to their quality of life scores and the investigators will analyze their~     differences in patterns of brain structures and activations.~   "
134423|NCT01295398|"~     The aim of the investigators study is to compare in children aged less than 18 months and~     hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile~     ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5~     µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a~     mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).~   "
134424|NCT01295385|"~     Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary~     microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial~     metabolism is frequently associated. It is regrettably about a hypothesis difficult to~     verify with current medical techniques.This deficiency being not only harmful to the~     diagnosis, but also to the assessment of the efficiency of the medical treatment on the~     myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance~     offer interesting perspectives.~   "
134425|NCT01295372|"~     To assess the effect of zicronapine versus risperidone on metabolic parameters comprising~     body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and~     glucose during 6 months of treatment.~   "
134426|NCT01295359|"~     The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and~     mortality, so it's important to find actions that could improve quality of life and decrease~     the mortality. The objective of this study is to verify if a ground walking program applied~     to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity,~     airways obstruction, body composition, heart rate variability, quadriceps isometric force~     and in the Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index (BODE~     index). An evaluators-blinded randomized controlled study will be conducted in Hospital~     Escola Municipal de São Carlos where forty patients will be recruited to participate. The~     volunteers will be randomized in two groups with twenty patients, the usual care group, that~     will receive only the usual care of the hospital; and the trained group that will receive~     the same care, but will also participate in a ground walking program associated with~     respiratory exercises. It will be evaluated, in the start and at the end of the program, the~     health related and general quality of life and the Barthel index. Daily, the patient will be~     submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test~     and to a dyspnea assessment, and will be calculated its BODE index. All patients will be~     invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would~     receive the same evaluation of the last day in the hospital. All the collected data will be~     expressed in means and standard deviations or medians and range when appropriated. It will~     be chosen appropriated tests to compare and correlate them.~   "
134427|NCT01295346|"~     The purpose of this study is to assess if putative brain injury biomarkers have utility as~     blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be~     accomplished by examining the relationships between potential serum-based TBI biomarkers and~     clinical measures of injury severity, occurrence of complications, and outcome, in subjects~     with mild or moderate TBI. The assay will be evaluated in a sample population of subjects~     over the age of 18 who have been referred to the health care provider for closed head injury~     evaluation.~   "
134428|NCT01295333|"~     The aim of our study is to compare in a randomized multicentric study the early prophylactic~     introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm)~     compared to a conventional approach based on the initiation of LT4 as soon as the first~     biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or~     minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy~     (clinical activity score to 0) will be included in this study. The administrated iodine-131~     activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue).~     Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The~     primary objective will assess differences in terms of quality of life at 3 months using a~     specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes~     at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck),~     autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment),~     efficacy and medico-economic data.~   "
134429|NCT01295320|"~     The subjects included in this study are subjects that participated in study NCT00434577.~     These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and~     Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for~     safety and immunogenicity.~      This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and~     safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.~      The study visits will be scheduled at approximately one year intervals after the first visit~     in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be~     taken from all subjects at each visit. Information on safety and the occurrence of HZ will~     also be collected during these visits.~   "
134430|NCT01295307|"~     In relapsed or refractory AML allogeneic HCT is considered to be the only treatment by which~     long-term disease-free survival can be achieved. Despite this favorable prospect, even in~     younger patients with relapsed AML only about 40% of the patients reach allogeneic HCT. A~     number of factors contribute to this low rate of transplantation, among them moderate~     activity of the salvage regimens and accumulating toxicities which prevent from~     transplantation; Prospective clinical trials in this indication usually focus either on the~     rate of CR achieved after a defined number of cycles of salvage therapy or on~     transplantation modalities. The consequent integration of salvage therapy into a transplant~     strategy accounting for the time-dependent process of donor search has not been studied so~     far.~      The objective of this study is to evaluate the safety and efficacy of clofarabine salvage~     therapy prior to allogeneic HCT.~   "
134431|NCT01295294|"~     The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic~     acid) can control irregular bleeding during the first 3 months of using Mirena. The study~     drugs tested are tested against placebo (dummy medication not containing any active drug).~     Treatment period is followed by a one-month period when study drugs are not taken but Mirena~     use is continued.~   "
134432|NCT01295281|"~     The hypothesis to be investigated is if the tolerability of intermittent catheterization~     with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal~     - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.~      Secondary objectives are to evaluate the safety and the subject's perception associated with~     the use of the catheters, assessed by the recording of adverse events and the ease of~     handling by means of a subjective assessment scale.~   "
134433|NCT01295268|"~     The goal of this study is to determine if vulvar (external female genitalia) pain is~     decreased with emu oil over a similar placebo oil (no active ingredient) by using~     measurement devices, examinations, and questionnaires. Topical emu oil has not been~     scientifically studied for this condition yet, but related reports show no significant side~     effects or potential benefits.~      A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.~   "
134434|NCT01295255|"~     Allergic rhinitis (AR) and asthma are considered as one airway, one disease. Although~     there is increasing evidence for an association between allergy and depression, it remains~     unknown if the relationship between AR and asthma has extra influence on the psychological~     status of the patients. The aim of our study was to investigate the influence pattern of~     asthma on the psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was~     employed to analyze the psychological status of 524 individuals with AR. Independent sample~     T-tests, one-way ANOVA and multivariate ANOVA were used for data analyses.~   "
134435|NCT01295242|"~     The purpose of this study is to determine rates of oral and genital human papillomavirus~     (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.~   "
134436|NCT01295229|"~     The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most~     significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass~     (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through~     mechanisms beyond just weight loss, but its role in diabetes management and the nature of~     its weight-independent anti-diabetes effects are not well established because of a paucity~     of appropriate randomized trials, the execution of which is hindered by numerous obstacles.~     The investigators therefore propose a feasibility study to demonstrate our capacity to~     identify, recruit, randomize, and track outcomes for 40 adult Group Health members~     identified as having T2DM and a BMI between 30-40 kg/m2.~   "
134437|NCT01295216|"~     Nearly half of the adult population in Latin American urban settings has abnormally high~     blood pressure. Although half of these subjects with high blood pressure are still in the~     pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or~     diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension~     is high (10-20% per year), according to studies done in other settings. The main objective~     of this proposal is to evaluate the effectiveness of an affordable and sustainable primary~     health care intervention to reduce blood pressure and prevent progression from~     pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina,~     Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive~     mHealth (mobile health) support for 12 months (intervention group) will have lower blood~     pressure compared to individuals who receive the usual primary health care (control group);~     and that pre-hypertensive subjects will maintain lower blood pressure six months after~     receiving mHealth support. The investigators will determine the effects of an intervention~     using mHealth technology, including short message services (SMS) and one-to-one telephone~     calls, to promote lifestyle modification focused on reducing blood pressure among~     participants. The intervention also aims to help participants become better informed,~     motivated, and encouraged to practice self-management of their own health; to improve~     patient satisfaction levels; provide tailored targeted interventions; and to improve~     patient-provider relationships. The proposal is designed as a proof-of-concept intervention~     in three Latin American countries that encompass a wide range of environments and health~     care settings. A total of 212 subjects (30-60 years old) per country will be recruited in~     primary health clinics and randomized to study groups. Blood pressure, anthropometry, and~     behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be~     measured at baseline and at months 6 and 12 during the intervention, and six months after~     the end of the intervention. The investigators will also evaluate feasibility,~     acceptability, cost-effectiveness, and process implementation of the intervention.~   "
134438|NCT01295203|"~     The purpose of this study is to determine whether access to a website with personalized~     feedback on physical activity level and suggestions to increase physical activity results in~     improvements in self-reported physical activity, anthropometrics and physiological~     measurements~   "
134439|NCT01295190|"~     Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary~     bypass at our institution without complications. However, propofol may cause propofol~     infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia~     with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS.~     Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary~     bypass, propofol has recently been substituted by sevoflurane during pediatric~     cardiopulmonary bypass at our institution. In this study the effect of substituting propofol~     by sevoflurane on metabolic acidosis and outcome are examined.~   "
134440|NCT01295177|"~     The purpose of this study is to determine whether topic insulin is effective to accelerates~     wound healing in diabetes patients~   "
134441|NCT01295164|"~     The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual~     simulator (AOVIS-I). The system provides an objective characterization of the optical~     quality of the patient's eye by application of wave-front sensing technology. The optical~     condition of every eye is represented by its wave aberration. This characterization~     overcomes the current description based only in refractive errors. This provides an accurate~     description of the optics of the eye based on the assessment of the whole set of ocular~     aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One~     characteristics of this wave-front sensor is its high dynamic range allowing measuring~     highly aberrated eyes, such as patients with keratoconus.~   "
134442|NCT01295151|"~     The principal aim of this study is to fill a clear knowledge gap and provide guidance for~     rheumatologists and reassurance to the patient group on a management challenge faced daily~     in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal~     management of patients with established RA that have failed an anti-TNF therapy (the first~     of the biological therapies to be introduced); in particular, the investigators wish to~     address whether the currently licensed but non NICE-approved treatment options, TNF-blocking~     drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the~     intention is to broaden treatment options and target these specific therapies to disease~     sub-groups.~   "
134443|NCT01295138|"~     Constipation following elective Caesarean sections (CS) is a common problem experienced by~     up to 50% of patients (1). The causes for this are multifactorial and include manipulation~     of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic~     techniques. To try to alleviate the problem of postoperative constipation, some~     anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia,~     although no data exists that shows whether this has any beneficial effect on postoperative~     constipation.~      1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4):~     190-4).~   "
134444|NCT01295125|"~     The purpose of this study is to compare open abdominal incisional hernia repair using~     XenMATRIX biologic mesh versus repair with their own tissue. This study will provide~     information in determining if a biological mesh is necessary to provide a sturdy repair for~     a ventral hernia.~   "
134445|NCT01295112|"~     This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®)~     eye injections reduces the need for repeat bevacizumab eye injections in patients with~     nonischemic central retina vein occlusion.~   "
134446|NCT01295099|"~     To clarify the mechanisms of Keloid scar formation.~      Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment~      Identify the genetic link with Keloid scar formation.~      Quantify the psychological/social impact in keloid scarring patients~   "
134447|NCT01295086|"~     The primary aim of this dose-finding study is to determine the maximum tolerated dose of~     taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third~     week as first-line treatment in patients with HER2-positive advanced gastro-esophageal~     cancer. Secondary end points are to evaluate progression-free survival and overall survival.~   "
134448|NCT01295073|"~     The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper~     chelator which is an agent that binds with and removes copper, will be effective in~     minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is~     our hypothesis that there will be a reduction in copper-attributed inflammation after~     surgery resulting a decrease in edema.~   "
134449|NCT01295060|"~     This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide~     Implant in patients that were previously treated with an Octreotide implant.~   "
134450|NCT01295047|"~     The investigators are looking at the different impacts of atenolol, verapamil and~     perindopril on large artery and lv function in marfan syndrome. It is a double-blind,~     randomised cross-over trial.~   "
134451|NCT01295034|"~     The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the~     adverse medication consequences of HIV/AIDS, but little is known about either the health~     benefits of vitamin D supplements, or about the optimal dosing regimen for patients on~     highly active antiretroviral therapy (HAART). This trial is a comparison of two regimens for~     administering vitamin D and calcium to HIV-positive individuals taking antiviral~     medications. This study will help physicians make evidence-based decisions about the most~     effective way to use vitamin D in their patients and enable the design of large multi-center~     trials in the future.~   "
134452|NCT01295021|"~     The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients~     with newly diagnosed essential hypertension.~   "
134453|NCT01295008|"~     The purpose of this study is to assess whether patients with the classic form of Fabry~     disease have significantly less androgenic alopecia (male pattern baldness).~   "
134454|NCT01294995|"~     Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term~     Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and~     CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented~     from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor~     fermented from above 5 grains plus green tea.~      Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled~     randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with~     meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids,~     inflammation biomarkers and CVD risk factors.~      TFL could significantly decrease systolic blood pressure of males, but increase diastolic~     blood pressure of females. TFL could also decreased blood lipid of volunteers, especially~     for females. Both liquor significantly decrease serum uric acid and glucose in males and~     females. The effect of the two liquors on inflammation biomarkers were complicated and needs~     further research work.~      TFL may possess more beneficial effect on CVD risk factors than GML probably because of the~     special fermentation products of green tea with other grains.~   "
134455|NCT01294982|"~     The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the~     study product, AOBO-001, when taken by adults with symptoms of overactive bladder. AOBO-001,~     is experimental, which means that the U. S. Food and Drug Administration (FDA) has not yet~     approved it for use. AOBO-001 has been approved in China as a prescription drug product to~     treat bedwetting in children. AOBO-001 is also approved in Hong Kong as a dietary supplement~     to improve quality of life for people with urinary incontinence. AOBO-001 is a botanical~     (from a plant) product. It is prepared from the seeds of Xanthoceras sorbifolia bunge plant,~     which is a flowering tree grown in Northern China. Approximately 60 subjects who are 18~     years of age and older are expected to participate in this study at up to 8 investigational~     sites. Each subject will complete 6 visits to the study site over a 14-week period. Subjects~     will consume 8 capsules of the assigned test product twice daily (that is, 16 capsules~     daily). Capsules will be taken with at least 6 ounces of water approximately 30 minutes~     before breakfast and 30 minutes before dinner. If a subject qualifies, he/she will be~     randomly (by chance) assigned to one of three study treatment groups. Subjects in one group~     will consume capsules containing a daily dose of 3.2 grams of AOBO-001; a second group will~     consume capsules containing a daily dose of 6.4 grams of AOBO-001; and a third group will~     consume capsules containing a placebo (no active ingredients). Subjects will have a 2 in 3~     chance of being assigned to an active study treatment group. Neither the subject nor the~     study doctor will know to which study treatment group the subject has been assigned, but~     this information is available in case of a medical emergency. There will be a time during~     the study dosing schedule when all subjects will consume capsules containing a placebo (no~     active ingredients). Subjects will not be told when they are receiving the placebo.~   "
134456|NCT01294969|"~     To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis~     previously treated with a topical ocular anti-allergy leukotriene-release inhibitor~     medication.~   "
134457|NCT01294956|"~     The purpose of this study is to estimate the change in sodium fluorescein staining, as a~     sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.~   "
134514|NCT01294215|"~     This is a clinical study evaluating the safety and efficacy of long term administration of~     oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in~     patients with essential hypertension who are not at target blood pressure by the combination~     of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.~   "
134458|NCT01294943|"~     The concern with oral infection and its systemic repercussions is old, many studies have~     been undertaken to establish this relationship more precisely. One of the areas mouth still~     little studied in this regard is the colonization of language within this universe of the~     oral microbiota colonization and how this may affect the general state of health~     care-dependent individuals.~      This research aims to evaluate the efficiency of a tongue cleaning device and its potential~     impacts on infectious patients fully or partially dependent care hospital.~      Patients admitted to intensive care units and inpatient units will be evaluated, divided~     into two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue~     cleaning device, and Control Group (CG) - Patients who are cared for according to the~     routine of hospital nursing.~   "
134459|NCT01294930|"~     Patients operated for hip fractures are older and have several conditions that have negative~     influences on the perioperative and postoperative prognosis.~      Hip fractures can also be painful, which is stressful for the physiology of the patient.~     Many old patients have received to little fluid intake. They often have diuretic therapy,~     which even worsens dehydration/hypovolemia.~      Some patients have to wait several days for surgery. Several studies have shown a high~     degree of complications and an increased mortality in this patient group.~      Early preoperative optimization can improve the outcome. The available methods for~     optimization of the patient are complicated and time consuming.~      The investigators wish with this study to try new approaches to find which patients still~     are dehydrated when they come to the operation ward.~      The aim is to measure the color and density of the urine as well as to register the the~     variability in the plethysmographic curve before spinal anaesthesia.~      These results will be compared to circulatory instability during and after surgery as well~     as to postoperative complications.~   "
134460|NCT01294917|"~     Crossover clinical evaluation three contact lens care regimens used for one month with~     Acuvue Oasys lenses.~   "
134461|NCT01294904|"~     Patients with chronic kidney disease (both men and women), especially those with terminal~     renal failure, manifest infertility. There has been demonstrated several hormonal changes in~     patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men~     (12). In women the opposite has been reported. The number of spermatocytes is reduced and a~     disturbance in maturation has been observed.~      This project is aimed to study the influence of uremic milieu on fertility in men and women.~     The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.~   "
134462|NCT01294891|"~     The purpose of this study is to examine how abnormal blood flow in the small vessels~     (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH)~     or sickle cell disease leads to poor functioning of the heart and kidney. To test this~     question, the investigators will perform imaging tests (contrast ultrasound perfusion~     imaging) to look at the flow and function of these microvessels and compare this information~     to heart and kidney function. To further look at this question, patients who have PNH will~     be studied before and after starting a new drug (Soliris) that decreases damage to blood~     cells. In patients with sickle cell disease, patients will be studied at baseline (not~     during a pain crisis) and also during a pain crisis if one develops.~   "
134463|NCT01294878|"~     By hypothesising that Interstitial Cystitis is an allergic disorder of the urogenital system~     that is linked to mast-cells, current therapy with omalizumab may represent a potential non~     symptomatic strategy for the treatment of IC/BPS~   "
134464|NCT01294865|"~     The purpose of the study is to investigate the plasma levels of Soluble Urokinase~     Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and~     to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.~   "
134465|NCT01294852|"~     The purpose of this study is to determine whether the immediate bolus strategy combined with~     early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation~     compared to the administration of surfactant prophylaxis at 15 minutes after birth with~     early nCPAP in premature infants.~   "
134466|NCT01294839|"~     This is a prospective, randomized, double blinded, multi-center, controlled study to~     evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site~     (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction~     prevention.~   "
134467|NCT01294826|"~     The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination~     with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal~     cancer.~   "
134468|NCT01294813|"~     Electrical Impedance Tomography (EIT)is a technique based on the injection of small currents~     and voltage measurements using electrodes on the skin surface generating cross-sectional~     images representing impedance change in a slice of the thorax. It is a radiation free,~     non-invasive and portable lung imaging technique. Impedance changes in lung ventilation are~     investigated in mechanically ventilated patients who routinely undergo bronchoscopy in~     intensive care medicine. Bronchoscopy is performed to suction secretions as well as to~     analyze the secretions to recognize inflammations and diseases. It is an essential~     intervention which causes changes in ventilation which remain for 1-2 hours. It is not~     completely investigated why these changes in ventilation remain for so long time and how~     they are distributed regionally. Therefore the purpose of this study is to investigate the~     change in pulmonary regional ventilation in patients who routinely undergo bronchoscopy to~     possibly generate ideas how to optimize the ventilation after bronchoscopy to optimize the~     patient´s treatment.~   "
134469|NCT01294800|"~     This study is to evaluate the efficacy of a range of preladenant doses compared with placebo~     in participants with moderate to severe Parkinson's disease (PD) experiencing motor~     fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by off time.~     Participants will continue to receive their stable regimen of L-dopa plus any adjunct~     medications during the study as prescribed by their physician. Several classes of adjunct~     medications may be used, including Amantadine, anticholinergics, dopa decarboxylase~     inhibitors, and dopamine agonists.~      Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to~     placebo as measured by the change from Baseline to Week 12 in the mean off time.~   "
134470|NCT01294787|"~     This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149)~     on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD).~   "
134472|NCT01294761|"~     The main objective of this clinical trial in randomizing HIV infected patients under good~     HIV control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir~     (LPV/r) into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or~     continuing the ongoing regimen to compare these two groups' estimated glomerular filtration~     rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other~     reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal~     functions and has the same virological efficacy in comparison with a standard treatment with~     TDF, or not.~   "
134473|NCT01294748|"~     The DESSOLVE II clinical trial is to assess the safety and performance of the~     sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in~     patients with symptomatic ischemic heart disease due to discrete de novo lesions in the~     native coronary arteries.~   "
134474|NCT01294735|"~     This is a non-randomized two-part study of MK-4827 given with temozolomide in participants~     with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the~     maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by~     increasing the MK-4827 dose level in successive cohorts. In Part B of the study,~     participants with advanced glioblastoma multiforme and advanced melanoma will be enrolled to~     further evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.~   "
134475|NCT01294722|"~     This is an observational study to estimate the proportion of patients diagnosed with RA~     visiting a medical internist in a general hospital in Korea who are candidates for anti‐TNF~     α therapy.~   "
134476|NCT01294709|"~     This study will assess the safety of telcagepant in coronary artery disease (CAD)~     participants with stable angina during exercise treadmill testing and evaluate whether~     calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise~     tolerance in these participants. Primary hypothesis is that telcagepant does not~     significantly decrease exercise duration compared to placebo, as measured by a treadmill~     exercise test; that is, the true treatment difference in exercise duration (MK-0974 -~     Placebo) >= -60 seconds.~   "
134477|NCT01294696|"~     This was a study to estimate the proportion of participants with osteoarthritis of the~     knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did~     not report adequate pain relief at Baseline and to characterize their pain level over a~     12-month follow-up period.~   "
134478|NCT01294683|"~     This study is being done to find out if tablets containing extended release (ER) niacin,~     laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin~     and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high~     cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM~     2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing~     low-density lipoprotein cholesterol (LDL-C).~   "
134479|NCT01294670|"~     The purpose of this study is to find out how safe and effective treatment with a new~     combination of drugs, vorinostat and etoposide, is in treating cancer. The medication~     etoposide is a standard medication used in the treatment of cancer in children. Vorinostat~     is an experimental drug which targets a protein(s) that control the way cancer cells grow~     and divide. Vorinostat is approved by the FDA in adults with certain cancers but not~     approved yet in children.~      There are two parts to this study. In the first part of this study, the phase I portion, a~     safe dose of the combination, vorinostat and etoposide. The goal of second part of this~     study, the phase II portion, is to see how effective the combination of vorinostat and~     etoposide is in treating cancer.~   "
134480|NCT01294657|"~     The goal of this research study is to learn if a motivation and problem solving (MAPS)~     program can help improve diet and levels of physical activity in African Americans who are~     overweight.~   "
134481|NCT01294644|"~     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of~     submental fat (fat below the chin).~   "
134482|NCT01294631|"~     The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide~     and canagliflozin on the concentrations of each drug in the blood and the concentration of~     glucose in the blood and urine in healthy adult volunteers.~   "
134483|NCT01294618|"~     The aim of this study is to demonstrate the safety and the efficacy of a combination of 2~     treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP~     CML) separately, but that have never been combined to date, and this combination is expected~     to substantially increase the molecular response rates.~   "
134484|NCT01294605|"~     This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™~     (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed~     by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of~     licensed Td vaccines in adults.~   "
134485|NCT01294592|"~     Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the~     efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful~     waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic~     benign prostate hyperplasia (BPH).~      Once consented, each subject will undergo screening procedures to ensure the prostate volume~     and post void residual are within eligible range. If all entry criteria are met, subjects~     will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or~     watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation~     will be initiated when no improvement from baseline is scored using the International~     Prostate Symptom Score (version 2) (IPSS) questionnaire.~      After randomisation, the subjects return to site at one month, then every 13 weeks until two~     years of treatment is complete or they are withdrawn. Key assessments, such as Adverse~     Events (AE's) and concomitant medication monitoring and completion of the quality of life~     questionnaires are performed at each visit and the data recorded.~   "
134515|NCT01294202|"~     The purpose of this study is to investigate if an investigational drug called AT13387 is~     active against Gastrointestinal Stromal Tumor (GIST) that is resistant to other treatments,~     and to understand more about the safety of AT13387.~      Most subjects in the study will receive AT13387 along with another drug called imatinib~     (Gleevec). Imatinib is a standard (approved) drug for treating patients with GIST. Some~     patients may receive AT13387 on its own. As a result, we shall begin to understand the~     effects of AT13387 given on its own and when combined with imatinib.We shall also find out~     more about the side-effects of AT13387, and more about how the body breaks down~     (metabolizes) AT13387.~   "
134486|NCT01294579|"~     The purpose of this phase II open label study is to evaluate the safety and efficacy of~     ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent~     B-NHL who have relapsed after Rituximab treatment. A maximum of 53 subjects at least 18~     years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular~     lymphoma; Grades 1, 2 and 3a, will be enrolled (34 in Stage 1 and 19 in Stage 2). Subjects~     should have Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete~     Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following~     completion of therapy or subjects should have relapse or disease progression following~     response to prior rituximab-based therapy and with a Eastern Cooperative Oncology Group~     (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on~     day 1 of each cycle (cycles 1-6) will be followed by Bendamustine 90 mg/m2 IV on days 1, 2~     of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the~     induction phase will receive ofatumumab 1000 mg IV every 2 months for 2 years.~   "
134487|NCT01294566|"~     This study is the First Time In Human study for the motilin receptor agonist, GSK1322888.~     GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from~     the motilide compound structures. The aims of this study are to assess the safety,~     tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a~     well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable~     isotope-labeled test meal in healthy volunteers.~      The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse~     events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.~   "
134488|NCT01294553|"~     An open label, multi-centre, non-interventional post-marketing surveillance to monitor the~     safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients~     according to the prescribing information~   "
134489|NCT01294540|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and~     healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy~     adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a~     single dose of 50 mg in healthy elderly volunteers.~   "
134490|NCT01294527|"~     The WiCS-LV system is an alternative means to providing left ventricular stimulation for~     Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety~     and performance of the WiCS-LV System in patients with indications for CRT.~   "
134491|NCT01294514|"~     The purpose of this study is to study Non-Invasive Performance evaluation of monitoring~     algorithm.~   "
134492|NCT01294501|"~     Giving medications to children can be confusing; studies have shown that caregivers make~     dosing administration errors up to 50% of the time. There are many reasons that there are so~     many errors, including the fact that dosing for children is based on their weight, liquid~     medications come in many different forms, and caregivers often give medicines using kitchen~     teaspoons and tablespoons. Caregivers who have difficulty reading have even more difficulty~     understanding medication instructions. We are developing and testing a web-based educational~     module to teach caregivers how to give medications. We are focusing on the pediatric~     emergency department because we know that this population has low literacy levels, and that~     many antibiotics are prescribed in this setting. We anticipate that those caregivers that~     view the interactive module will have increased knowledge on how to give medications once~     they get home.~   "
134493|NCT01294488|"~     The overarching aim of the proposed study is to test the implementation effectiveness of two~     implementation approaches—Remote Real-Time (RRT) using the internet telemedicine technology~     and traditional Phone Consultation (PC) for training practitioners in PCIT. The study will~     add to emerging knowledge about how technology can facilitate the transport of~     evidence-based intervention models into field settings.~   "
134494|NCT01294475|"~     The goal of this project is to examine the effects of the use of cellular-phone technology~     in conjunction with a parenting program entitled Planned Activities Training (PAT) on~     participant enrollment, engagement, and motivation for the PAT intervention, as well as on~     parent and child outcomes.~   "
134495|NCT01294462|"~     The purpose of the study is to assess the efficacy (prevention of vascular events) and~     safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given~     on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a~     planned percutaneous coronary intervention (PCI).~   "
134496|NCT01294449|"~     MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the~     MADIT-CRT IDE study examining long-term mortality.~      (MADIT-CRT IDE: NCT00180271)~   "
134497|NCT01294436|"~     This is a long term, single arm, open label study to evaluate the safety and efficacy of~     dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in~     Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on~     diet and exercise or on other anti-diabetic treatment will be included in this study.~   "
134498|NCT01294423|"~     This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and~     safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus~     who have inadequate glycemic control with diet and exercise.~   "
134499|NCT01294410|"~     The purpose of this study is to determine whether BMS-936557 is effective in the treatment~     of moderate to severely active ulcerative colitis in patients who have had insufficient~     response and/or intolerance to other medical therapy for ulcerative colitis~   "
134500|NCT01294397|"~     This is a multi-center, open-label, single sequence, denosumab single-dose study in~     postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis (RA) being~     treated with etanercept.~   "
134501|NCT01294384|"~     This study will investigate the safety, efficacy and acceptability of two new eye drop~     formulations compared with Refresh Tears® in patients with dry eye disease.~   "
134502|NCT01294371|"~     The purpose of this study is to assess rates of administration of add-back therapy in~     patients with endometriosis in the Russian Federation, during a 6-month course of~     gonadoliberin agonist leuprorelin 3.75 mg.~   "
134516|NCT01294189|"~     Description of the decision making process as well as the practices of end of life care in~     an ICU of a German university hospital during the period when changes of German legislation~     occurred.~   "
134503|NCT01294358|"~     Background:~      - Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the~     tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink~     some of the tumor, but even with chemotherapy only about 25 percent of patients will live~     for 1 year following diagnosis. Several preliminary studies have shown that it is safe to~     give chemotherapy directly into the pancreas in the area of the tumor, and that giving~     gemcitabine over a longer period increases the amount of drug that is available to the~     tumor. Researchers are interested in studying whether giving the approved pancreatic cancer~     chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a~     slow rate of infusion is a safe and effective treatment.~      Objectives:~      - To test the safety and effectiveness of administering gemcitabine directly to a pancreatic~     tumor at a slow rate of infusion.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that~     is currently too large to be removed surgically but has not yet spread to other organs.~      Design:~        -  Participants will be screened with a full medical history and physical examination,~          blood and urine tests, and imaging studies.~        -  Participants will undergo pancreatic angiography and embolization, during which a~          catheter will be threaded into the blood vessels near the pancreas and a contrast dye~          will be used to show the blood vessels supplying the tumor. These blood vessels will~          then be surgically closed off.~        -  After the embolization, gemcitabine will be given as an infusion into the area around~          the tumor over 24 hours.~        -  Participants will return to the clinical center every 2 weeks after the first infusion~          for additional infusions of gemcitabine, using the same procedures as above.~          Participants will be monitored with frequent blood tests and imaging studies.~        -  Two weeks after the fourth treatment (course 1), participants will have more imaging~          studies, a physical examination, and blood tests. If the tumor is shrinking,~          participants will have two more courses of treatment (eight more infusions of~          gemcitabine).~        -  Participants will have followup visits every 3 months for 2 years following the last~          treatment and then every 6 months.~   "
134504|NCT01294345|"~     Background:~      - Congenital malformations, sometimes called birth defects, occur because of a difference in~     early human development. There are many different types of congenital malformations, and~     some of these can be caused by changes in genetic material. Researchers are interested in~     studying individuals with these congenital malformations to better understand the causes and~     the effects of certain congenital malformations.~      Objectives:~        -  To understand more about what causes congenital malformations that arise in early human~          development.~        -  To learn if genetic causes can be found to explain why a person has a congenital~          malformation.~      Eligibility:~      - Individuals who have been diagnosed with a congenital malformation.~      Design:~        -  Participants will be seen at the National Institutes of Health for a series of visits~          over 3 to 4 days. Participants will be asked to provide copies of past medical records~          and test results for review, and will be asked questions about pregnancy/prenatal~          history, birth, newborn, medical, developmental, and family history.~        -  Parents or siblings of participants may also be asked to provide information for~          research purposes.~        -  Participants may have additional medical evaluations as part of this study, including~          any of the following tests:~        -  Physical examinations~        -  Other consultations as clinically indicated~        -  Blood samples for genetic testing~        -  Tissue biopsy for genetic testing~        -  Photographs of affected areas, such as front and side views of the face and other body~          parts that may be involved in a congenital malformation, like the hands and feet.~        -  Other tests as indicated by a specific malformation, such as organ ultrasounds.~        -  No additional invasive testing, testing requiring sedation, or testing involving~          radiation is planned for this protocol. These tests, if performed, would involve a~          separate consent.~   "
134505|NCT01294332|"~     Background:~      - Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low~     physical fitness causes severe fatigue that reduces the ability to perform routine daily~     activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise,~     such as treadmill walking or running, improves physical fitness in most people and may also~     decrease fatigue and improve mood. However, more information is needed to determine if~     exercise improves these conditions in people who have TBI.~      Objectives:~      - To examine the effect of an aerobic treadmill walking exercise program on physical~     fitness, fatigue, and mood in people with TBI.~      Eligibility:~      - Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury~     at least 6 months before participating; able to understand oral and written English~     language, give informed consent and sign a consent form; are physically inactive (including~     activities related to both job and recreation); and are able to stand and walk on a~     treadmill safely without help.~      Design:~        -  This study requires 4 testing visits and 36 exercise visits over 14 weeks.~        -  The first and third testing visits will last about 4 hours and the second and final~          testing visits will take about 2 hours.~        -  Testing visits will consist of a medical history and physical examination, completion~          of questionnaires (about fatigue, daily physical activity, sleep quality, mood, and~          overall quality of life), tests of thinking and a treadmill exercise test.~        -  Participants will have treadmill exercise training 3 days per week for 12 weeks. Each~          session includes a check-in, warm-up, treadmill walking at the training heart rate, and~          cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the~          sessions will include questionnaires to fill out and will last about one-and-a-half~          hours.~        -  After completing the exercise training program, participants will have a final testing~          visit to complete the questionnaires (about fatigue, daily physical activity, sleep~          quality, mood, and overall quality of life), tests of thinking and a treadmill exercise~          test.~   "
134506|NCT01294319|"~     Background:~        -  The adrenal glands, located above the kidneys, produce hormones called glucocorticoids~          and mineralocorticoids. Glucocorticoids, especially the hormone cortisol, act on nearly~          all cells in the body with effects that are especially important to the body's stress~          response. They maintain heart function, blood pressure, and proper blood sugar levels,~          and help regulate the body's responses to infections and injury. Mineralocorticoids~          help to regulate salt and water levels in the body.~        -  Blood levels of cortisol have a natural day-to-night pattern: the highest levels occur~          in the morning and the lowest levels occur at night. This pattern is regulated by the~          hormone ACTH, which is made by the pituitary gland, and causes increased or decreased~          cortisol levels in response to the levels in the blood. Research has shown that older~          men have higher ACTH and cortisol levels than younger men, and that endurance-trained~          athletes have different cortisol levels than more sedentary individuals. Researchers~          are interested in studying these differences in cortisol levels and their potential~          effects on health.~      Objectives:~      - To compare cortisol levels and responses in sedentary young men and endurance-trained male~     athletes and elderly men.~      Eligibility:~        -  Healthy men between 18 and 30 years of age who have exercised less than 1 hour each~          week for the past 3 years.~        -  Healthy men between 18 and 30 years of age who have regularly run more than 45 km (28~          miles) per week for at least 3 months.~        -  Healthy men between 65 and 80 years of age who have exercised less than 1 hour each~          week for the past 3 years.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine samples.~        -  Participants will collect saliva and urine samples at home, both for cortisol~          measurements. Saliva samples should be collected in the evening on 2 separate days, and~          urine samples should be collected continuously for 12-hour intervals (7 AM to 7 PM and~          7 PM to 7 AM) over a single 24-hour period. Participants will provide baseline blood~          samples at the National Institutes of Health when they drop off the saliva and urine~          samples.~        -  Participants will have four separate evening/overnight tests at the National Institutes~          of Health. At these tests, participants will take study drugs or a look-alike capsule~          to block the effects of only glucocorticoid, only mineralocorticoid, both~          glucocorticoid and mineralocorticoid, or neither. Blood, saliva, and urine samples will~          be collected regularly from 7 PM to 7 AM the next morning.~        -  Participants will have a final clinic test in which they will take dexamethasone late~          in the evening (11 PM to midnight) and visit the National Institutes of Health by 8 AM~          the next morning to provide a blood sample.~   "
134507|NCT01294306|"~     This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and~     erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer~     who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and~     erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
134508|NCT01294293|"~     This phase I trial is studying the side effects and best dose of TLR8 agonist VTX-2337 and~     pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or~     persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Biological~     therapies, such as TLR8 agonist VTX-2337, may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal~     doxorubicin hydrochloride and paclitaxel, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving TLR8 agonist~     VTX-2337 together with pegylated liposomal doxorubicin hydrochloride or paclitaxel may kill~     more tumor cells.~   "
134509|NCT01294280|"~     This research trial studies prognostic and predictive markers in patients with early stage~     non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor~     factors that predict patient survival independent of treatment. Predictive markers are~     factors that may influence and predict the outcome of treatment in terms of either response~     or survival benefit. Collecting and storing samples of tissue from patients with cancer to~     study in the laboratory may help doctors learn more about cancer and identify biomarkers~     related to cancer.~   "
134517|NCT01294176|"~     The purpose of this study is to determine if oral lipoic acid can safely help relieve~     permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also~     explore how the body absorbs and breaks down the study drug, and what effects it has on the~     immune system.~   "
134518|NCT01294163|"~     Xenon is a gaseous anaesthetic agent registered in several European countries. It has been~     administered safely during cardiac surgery in pilot studies. In animal studies, xenon~     decreases the size of experimental myocardial infarction.~      This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous~     anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery~     conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered~     before and after extracorporeal circulation. Propofol will be administered during~     extracorporeal circulation in the three groups of patients.~      The study will compare the postoperative myocardial damage observed 24 hours after surgery~     from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The~     main hypothesis is that the myocardial damage observed after xenon administration will not~     be superior to the damage observed after sevoflurane administration (non-inferiority). The~     second hypothesis is that the myocardial damage observed after xenon administration will be~     inferior to the damage observed after total intravenous anaesthesia.~   "
134519|NCT01294150|"~     The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R)~     System when used in subjects with symptomatic benign hyperplasia (BPH). Primary~     effectiveness will be achieved by looking at the improvement of International Prostate~     Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.~   "
134520|NCT01294137|"~     Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be~     different than in the youngest people, and its consequences might be severe and atypical~     (falls, functional and cognitive decline).~      Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this~     study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in~     sleep apnea in the hospitalized elderly.~   "
134521|NCT01294124|"~     The investigators hypothesize that individual differences exist in resting-state cortical~     attention, control, sensory, and emotion networks prior to noise exposure and these~     differences predispose some to the development of bothersome tinnitus. Furthermore, the~     investigators hypothesize that these changes in functional connectivity of these vulnerable~     systems after noise exposure are responsible for tinnitus. The proposed study will use a~     case-control cohort study design. Cases will be those soldiers who develop tinnitus and~     controls will be those who do not. This will be the first prospective study of tinnitus and~     will provide important information about the neurobiology of tinnitus.~      If a cortical neural network etiology for bothersome tinnitus is confirmed, it will be an~     astounding, powerful, paradigm shifting model for the diagnosis, prevention and, most~     importantly, treatment of tinnitus. Furthermore, if a battery of neurocognitive tests can~     identify soldiers at risk for the development of tinnitus then appropriate primary~     prevention strategies can be introduced.~      There are three Specific Aims to this project.~      Specific Aim 1. To determine if soldiers who develop tinnitus display pre-deployment~     differences in a set of physical, functional, cognitive, vulnerability, perpetuating~     factors, pre-deployment neurocognitive scores, or neuroimaging features compared to soldiers~     who do not develop tinnitus (control group).~      Specific Aim 2. To determine if particular scores on neurocognitive tests or neuroimaging~     features of functional/structural connectivity networks are associated with the development~     of tinnitus.~      Specific Aim 3. To identify a set of pre-deployment physical, functional, cognitive,~     vulnerability, and perpetuating factors, neurocognitive responses, and neuroimaging features~     that are associated with the development of tinnitus.~      The investigators plan to recruit 200 soldiers, between the ages of 18 and 30 years who do~     not have hearing loss or tinnitus and have never been deployed to military theater. The~     soldier participants will undergo a variety of tests before and after deployment, which will~     include a hearing test, neurocognitive tests (i.e., brain function tests), and a variety of~     novel radiologic imaging studies of the brain. One of these novel radiologic imaging studies~     is functional connectivity Magnetic Resonance Imaging, a proven methodology that monitors~     changes in brain activity and connections based on blood flow between different brain areas~     and levels of consumption of oxygen. This information is used to describe the condition of~     important neural networks responsible for such things as attention, mood, sensation, vision,~     hearing, and introspection or self-contemplation.~   "
134522|NCT01294111|"~     Physical activity is recommended in the treatment of heart failure. Elderly people demand~     various forms of physical activity. Tai chi has shown to be an appreciated form of physical~     activity among elderly, although there is a lack of studies focusing people aged 70 years~     and older.~      The overall goal with the project is to find a form of physical activity that is safe and~     free from side effects, suitable for elderly people with chronic heart failure. The~     hypothesis is that for patients participating in tai chi training during three months the~     degree of self rated fatigue will be reduced and health-related quality of life will~     increase, compared with a control group receiving ordinary care. The primary aim is to study~     the effect of tai chi training on fatigue and health-related quality of life. A second aim~     is to study effects on physical function and levels of brain natriuretic peptide (BNP) in~     blood plasma. A tertiary aim is to describe the experience of participating in tai chi~     training.~      A randomized controlled clinical study is planned. Ninety patients with a verified diagnosis~     of heart failure in the age of 70 years or older, who experience fatigue according to the~     Multi Fatigue Inventory (MFI-20), will be randomized to intervention or control group. Three~     groups with 15 participants each will complete a tai chi training programme twice-weekly for~     16 weeks. Data will be collected at baseline, directly after the 16 weeks of training, and 6~     and 12 months thereafter. The programme is worked out by an expert in Chinese traditional~     medicine to suit elderly people with chronic heart failure, and the classes are led by~     experienced leaders. Before the start of the study a small pilot study was conducted to test~     the feasibility of the programme. A group of seven patients completed the programme for~     eight weeks without any problems.~      If tai chi has a good effect on fatigue, health-related quality of life and physical~     function, this form of physical activity can be a valuable complement to other medical~     treatment. Tai chi has a potential to be offered to many patients to a relatively low cost.~     It can be practiced in groups or in private, and also through internet connection.~   "
134523|NCT01294098|"~     The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve~     blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a~     pediatric population.~   "
134524|NCT01294085|"~     To assess the difference of prognosis between unresectable and recurrent biliary tract~     cancer and evaluate prognostic factors.~   "
134525|NCT01294072|"~     This clinical trial will investigate the ability of plant exosomes to more effectively~     deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of~     turmeric, a natural product with diverse biological activities. Exosomes are small~     endosome-derived vesicles (50-100 nanometers [nm] in size). Previous clinical trials~     conducted with oral curcumin have demonstrated only limited bioavailability even at very~     high doses of 8-12 grams per day. This trial plans to address this problem of curcumin~     delivery by using plant exosomes to deliver the drug to colon tumors and normal colon~     tissue.~   "
134526|NCT01294059|"~     Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain,~     including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles~     (mechanical) found in almost all FM patients. Milnacipran, a balance~     norepinephrine-serotonin re-uptake inhibitor, has been found to reduce pain and improve~     physical function of FM patients. However, little is known about the pain mechanisms that~     are affected by this medication. Therefore, the investigator wants to determine the efficacy~     of milnacipran in reducing pain as well as mechanical and thermal hyperalgesia of FM~     patients during a randomized, double-blind, placebo controlled trial. Because the~     investigator expects anti-hyperalgesic effects to coincide or precede with effects on~     clinical FM pain the proposed duration for this trial is 6 weeks.~   "
134527|NCT01294046|"~     This investigation will gather information about a procedure called sphenopalatine ganglion~     (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those~     who suffer migraine headaches which may result in chronic severe disability. The SPG is a~     small collection of nerve cells in the head, and is located near the base of the nose on~     either side. Participation involves the surgical implantation of an electrode (small~     electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a~     stimulator which will enable treatment for migraine headaches. Tiny electrical current is~     delivered to the stimulator device by an internal pulse generator implanted in the area at~     the top of the chest, to stop the migraine headaches. The implant system will be controlled~     with a wireless remote provided after the implant procedure.~      Participation will record headache diaries throughout the study, which will last~     approximately 8½ months, and a yearly visit annually for five years.~   "
134528|NCT01294033|"~     Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic~     obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of~     supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and~     other ventilatory parameters during maximal exercise in the resting normoxic Chronic~     Obstructive Pulmonary Disease population is poorly defined. The investigators performed a~     randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise~     tests on room air and supplemental oxygen. The investigators compared maximal oxygen~     consumption and other ventilatory parameters in each individual subject under the two~     conditions.~   "
134529|NCT01294020|"~     Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to~     Advagraf® immunosuppression to compare exposure and follow for safety and efficacy over one~     year.~   "
134530|NCT01294007|"~     The purpose of this study is to evaluate the rate and quality of fusion of PureGen~     Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral~     fusion (PLF) procedures.~   "
134531|NCT01293994|"~     The investigators will be collecting saliva DNA samples from chronic back pain patients. The~     investigators hope to find candidate genes associated with response to opioid medication by~     correlating molecular genetics data with pain measurement and opioid responsiveness data~     including opioid hyperalgesia and opioid analgesic tolerance.~   "
134532|NCT01293981|"~     The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor~     Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.~   "
134533|NCT01293968|"~     The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and~     Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)~   "
134534|NCT01293955|"~     -  A Pilot study~        -  Randomized and Double-blinded~        -  Placebo controlled~        -  In 2 parallel group (JOINS 200mg:Placebo = 1:1)~        -  Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional~          follow-up assessment up to 24 months)~        -  Provide rescue medicine throughout whole clinical trial period.~   "
134535|NCT01293942|"~     The percentage of patients with defined unresectable metastatic disease who will benefit~     from a first-line treatment enabling secondary complete metastasectomy is unknown but~     limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous~     patient populations.~      This open label, multicentre Phase II study primarily aims to assess the resection rate~     achievable in a selected patient population with initially unresectable metastatic disease~     limited to the liver only in order to evaluate feasibility, safety and efficacy with regards~     to secondary resection of hepatic lesions in these patients.~      The trial aims to enrol only patients meeting defined criteria of unresectability with~     regards to their hepatic lesions and will exclude patients with extrahepatic lesions in~     order to examine the most appropriate, highly active treatment regimen for this group of~     unresectable patients with the highest probability of a successful secondary metastasectomy~     with curative intent. The trial will be conducted in highly specialized centres with a track~     record of successful interdisciplinary treatment approaches in the field of metastatic~     colorectal cancer to allow the precise assessment of the peri-operative safety parameters as~     well as an evaluation of the surgical treatment approaches.~      The IXO regimen selected for this study has shown in a phase I/II study promising efficacy~     and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit~     in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will~     allow evaluation of its potential benefit in combination with the two most active current~     chemotherapy regimens in the first-line and post-operative treatment setting.~   "
134536|NCT01293929|"~     Chemerin is a novel adipokine that might provide a link between chronic inflammation and~     obesity. Pulse wave velocity(PWV) is a useful method for examining arterial stiffness,~     meaning early-stage atherosclerosis. Therefore, in the present study, the investigators~     examined the relationship between circulating chemerin and arterial stiffness measured using~     PWV in obese persons.~   "
134537|NCT01293916|"~     Prospective randomized controlled trial comparing use of single leg spica with double leg~     spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years~     old.~   "
134538|NCT01293903|"~     The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely~     associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin~     capsule, a Chinese medicine, could enhance heart function in chronic heart failure and~     regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore~     the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in~     patients with DCM, patients were recruited, anti-heart autoantibodies and some~     representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the~     efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo~     under the standard treatment of DCM.~   "
134539|NCT01293890|"~     Chronic Obstructive Pulmonary Disease (COPD) represents one of the most challenging chronic~     diseases of the 21st century: it is expected to be the fourth leading cause of death by~     2030. COPD is characterized by pulmonary and extra-pulmonary systemic manifestations caused~     by partly irreversible expiratory airflow obstruction. The cornerstone of COPD management is~     the prescription of single or combined inhalation therapy, such as short- and long-acting~     bronchodilators, inhaled corticosteroids to possibly prevent disease progression, preserve~     lung function, relieve respiratory symptoms and prevent or treat exacerbations. Given the~     complex and lifelong treatment, one can expect that adherence to the prescribed inhalation~     therapy is not self-evident. Adherence can be defined as the the extent to which a person's~     behaviour (taking medications, following a recommended diet and/or executing life-style~     changes) corresponds with the agreed recommendations of a health care provider. Inhaled~     medications have an additional complexity in that patients who intend to be adherent may be~     take the inhaled medication incorrectly, prohibiting proper therapeutic action. Taking less~     than the prescribed amount of medication, missing doses or stopping treatment for brief or~     extended periods will put the patient at risk for suboptimal disease control. Hence, the~     effectiveness will largely depend on the patient's ability to manage their disease~     adequately in daily life.~      Using electronic monitoring, 3 studies in COPD found a prevalence of medication~     non-adherence of 51% which was worse than the average prevalence of 29% (range 3-66%) found~     across diseases such as hypertension, cancer, epilepsia, infections and HIV.~      The existing evidence on risk factors for nonadherence in COPD is mostly anecdotic and not~     guided by behavioral models. According to the integrated model of behavioral prediction~     (IMBP), barriers, skills and ability and intention are the most important drivers of~     adherence (i.e. medication adherence).~      The aims of the study are the following:~        -  To prospectively investigate the impact of medication nonadherence on time to~          exacerbation (primary end-point) and exacerbation rate, FEV1, hospitalization rate and~          duration, and quality of life (secondary end-points) at 1 year follow-up using~          electronic monitoring~        -  To investigate risk factors for medication nonadherence, using the Integrated Model of~          Behavioral Prediction as a theoretical framework~        -  To determine the diagnostic accuracy of different measures of medication nonadherence~          (i.e. pill count, self-report and physician rating) relative to electronic monitoring.~        -  To investigate the prevalence of nonadherence to other aspects of the therapeutic~          regimen, i.e. the use of concomitant medications, smoking cessation, alcohol use,~          physical activity, attendance to rehabilitation sessions and dietary adherence, their~          interrelations, and impact (alone and in combination) on time to first exacerbation.~        -  To investigate the interrelations in adherence to the various components of the~          therapeutic regimen.~        -  To investigate the impact of nonadherence to the other components of the therapeutic~          regimen (alone and in combination) on clinical outcomes (i.e. time to exacerbation,~          exacerbation rate/PPY, FEV1, hospitalization rate and duration, and quality of life at~          1 year follow-up.~   "
134540|NCT01293877|"~     The study must be performed in 100 patients suffering from morbid obesity, the procedure~     will be performed under general anesthesia doing two or three layers of suture to achieves~     gastric imbrication until transform the stomach to a sleeve. The patients will be followed~     during the time for 6 month, 1 year, two years and 5 years.~   "
134923|NCT01288885|"~     This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics~     (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether~     the intake of food had an effect on the PK of ASP1941 (Part B).~   "
134541|NCT01293864|"~     The object of this study is to analyze fresh human skin samples using several up-to-date~     technologies to get parameters on the mechanical, biochemical and structural distribution of~     the main components of the capillary-tissue unit.~      Our working hypothesis is that both structural components of the dermis are not evenly~     distributed along parallel planes. The investigators further hypothesize the the~     distribution patterns determine functional and mechanical differences along dermal layers.~   "
134542|NCT01293851|"~     Background:~      - Docetaxel, the most commonly used drug for the treatment of invasive breast cancer, has~     been shown to prolong the lives of women with breast cancer and prevent the cancer from~     spreading or returning. However, docetaxel is known to cause nerve damage, including~     numbness, tingling, and pain, in 50 to 90 percent of breast cancer patients. This nerve~     damage is called peripheral neuropathy, and can be so severe that treatment with docetaxel~     may need to be stopped. Researchers are interested in studying docetaxel-related nerve~     damage to determine whether certain genetic factors may predispose women to developing this~     condition, and to more closely investigate the specific effects of docetaxel on the nervous~     system~      Objectives:~      - To examine nerve damage in women with breast cancer who are being treated with docetaxel.~      Eligibility:~      - Women at least 18 years of age who have been diagnosed with invasive breast cancer and are~     scheduled to have docetaxel treatment.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests and imaging studies.~        -  This study requires seven visits, one before the start of chemotherapy and six after~          the scheduled treatment visits. Study procedures at each visit will take 30 to 45~          minutes and will be done in parallel with scheduled chemotherapy visits.~        -  At the first visit, participants will provide blood samples; complete questionnaires to~          rate and describe any existing pain, numbness, or tingling in hands and feet before the~          start of chemotherapy; have nerve conduction tests; and have a skin biopsy.~        -  At each visit following docetaxel treatment, participants will complete questionnaires~          to rate and describe any pain, numbness, or tingling during the course of chemotherapy.~          Participants will provide blood samples at every visit and have nerve conduction tests~          during the second, fourth, and sixth visits. Participants will also have a second skin~          biopsy, either from a site that appears to be experiencing nerve damage or (for those~          who are not developing nerve damage symptoms) from a site near the first biopsy~          location.~   "
134543|NCT01293838|"~     The primary objective is to examine whether Cipralex® is effective and safe in the treatment~     of anxiety disorders in youth. The secondary objective is to identify changes in arousal and~     stress response from pre- to post-treatment with Cipralex® in youth with anxiety disorders.~   "
134544|NCT01293825|"~     Psychotropic-related weight gain is a common concern among patients with bipolar disorder~     (BD). This concern affects an individual's satisfaction with treatment and may lead to~     reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns~     while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA~     approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight~     gain compared to some alternative BD maintenance treatments. The proposed project will~     evaluate how switching to ziprasidone may affect patient adherence, drug attitudes,~     satisfaction with care and clinical outcomes (psychiatric symptoms, functional status,~     weight) among BD patients concerned with weight gain.~   "
134545|NCT01293812|"~     Background : Previous studies suggest that early recognition and treatment of pain among~     children is important for their cognitive development and their future response to pain~     throughout their life. Oral sweet solutions have been accepted as effective pain reducing~     agents for procedures in the neonatal population. To date, there have been a limited number~     of published clinical trials in an emergency setting studying this type of intervention~     among infants and these studies have shown conflicting results.~      Objective : To compare the efficacy of an oral sucrose solution versus placebo in reducing~     pain in children 1 to 3 months of age during venipuncture in the Emergency Department (ED).~      Methods : A single-center, randomized, double-blind, placebo controlled clinical trial will~     be conducted in an urban tertiary care pediatric university-affiliated hospital ED. The~     study population is all infants from 1 to 3 months of age requiring venipuncture as part of~     their planned ED management. Study participants will be randomly allocated to receive 2 ml~     of a 88% sucrose solution or 2 ml of a placebo solution. The primary outcome measure is the~     difference in pain levels during the venipuncture in the study population as assessed by the~     Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC). Secondary outcome measures~     will evaluate differences of pain levels using the Neonatal Infant Pain Scale (NIPS). Crying~     time and changes in heart rate during the procedure will be recorded. Side effects and~     adverse events will also be noted. The investigators will also measure the number of~     successful venipunctures at the first attempt. Based on previously reported data, using an~     alpha value of 0,05, a power of 90% and using a 2-point difference in mean FLACC scores as~     clinically significant difference, approximately 41 patients per group will be needed~     considering a drop-off value of 25%. Patients' characteristics and outcomes will be compared~     using the Pearson Chi-square test for categorical variables and the Student's T test for~     continuous variables. A intention to treat analysis will be performed.~   "
134546|NCT01293799|"~     BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis. It is the~     leading cause of technique failure, and contributes to mortality. The incidence is highest~     during the first year of treatment. Non-compliance with the Peritoneal Dialysis (PD)~     protocol is shown to be an important risk factor for peritonitis. Reinforcement of knowledge~     and ability to perform PD therefore appears to be a possible way to reduce the incidence of~     peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS).~      METHODS: The objective of this randomized, multi-centre investigation,which will include 750~     new PD patients who can perform (PD) without assistance, is to evaluate if regular~     retraining can reduce the incidence of peritonitis, the technique-failure rate, and the~     hospitalisation days due to peritonitis compared with regular follow-up regimen. Patients in~     the intervention group will tested by a PD-technique test and a questionnaire at regular~     intervals after PD-start and after every peritonitis episode with focus on infection~     prophylaxis. If needed, they will be retrained. The control group will be treated according~     to the routine of the center.~      The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands,~     and the UK. The study will go on for 6 years.~   "
134547|NCT01293786|"~     Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced~     kidney function. Low serum magnesium is more prevalent in KT recipients. The present study~     examines the difference in vascular calcification between KT and CKD and its association~     with serum magnesium.~   "
134548|NCT01293773|"~     Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the~     prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578-~     versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with~     de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.~      Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary~     End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death,~     myocardial infarction and repeated lesion revascularization within 12 months.~      Secondary End-Points: 1) impact of glucose level during the first three months following the~     procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion~     revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus~     prolonged (> 12 months) of dual antiplatelet therapy~   "
134562|NCT01293591|"~     This study is being done to study the healthful benefits of eating garlic. Previous studies~     suggest that garlic may help prevent cancer. The investigators are recruiting healthy~     volunteers to participate in a study to determine the ways in which eating garlic may reduce~     cancer risk.~   "
134549|NCT01293760|"~     The purpose of this study is to determine, in a pilot setting, if this study is feasible in~     terms of recruitment, willingness to be randomized, provision of contraceptive methods, and~     follow-up. The investigators hypothesize that this pilot study will be feasible in terms of~     recruitment, provision of care, and follow-up.~      The study will be a pilot randomized controlled trial comparing outcomes of immediate~     post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of~     the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing~     scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be~     powered to detect a difference, but rather the investigators will enroll all eligible and~     interested women during the three-month enrollment period. Potential participants who do not~     choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.~   "
134550|NCT01293747|"~     Phase I pharmacokinetic study~      Main objective:~      To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone~     on each of the formulations studied, after multiple-dose administration~      Study design:~      Randomized, controlled, open-label, parallel, pharmacokinetic study~      Sites: 1~      Subjects: 30 postmenopausal women~   "
134551|NCT01293734|"~     Bronchial asthma is a common disease and frequently encountered disease of respiratory~     apparatus. It has very complex mechanism and multiple inducing factors. This study will~     focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of~     internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical~     practice. The study will also investigate the efficacy of the Chinese drugs and treatments~     on Bronchial asthma, and provide an effective therapy for this disease.~   "
134552|NCT01293721|"~     Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong~     Kong, the total number of hip fracture cases is anticipated to increase substantially in the~     future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip~     fracture usually causes severe pain and takes long time (4-8months) to recover due to~     impaired healing capability in osteoporotic bones and limited mobility. Consequently, the~     patients will recover very slowly as a result of low physical activities to provide~     inadequate mechanical stimulation. It is also known that mechanical, vascular and biological~     factors are the keys for fracture healing.~      Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to~     provide whole-body vibration signals for mechanical stimulation, which has been proven to be~     good in enhancing bone and muscle performance, as well as blood circulation. Our previous~     study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted~     from enhanced callus formation and maturation. Application of LMHFV on osteoporotic~     fractures could shorten the period of complete callus bridging by 30%. Our clinical trial on~     normal elderly also demonstrated improved muscle performance with good compliance, which is~     also a critical factor for fracture healing.~      In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture~     healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle~     recovery, thus improving implant mechanical stability and rehabilitation in elderly~     patients. The hip fracture elderly patient will be recruited and randomized into control or~     treatment group. They will be assessed on the fracture healing at fixed time point. The~     findings of this study will provide very useful scientific data to support the application~     of LMHFV for hip fracture patients.The ultimate goal is to enhance the fracture healing and~     rehabilitation in elderly patients.~   "
134553|NCT01293708|"~     The purpose of this study is to understand the realities, expectations and attitudes of~     patients 80+ and their families about the use of life-sustaining technology, and to document~     the patient outcomes and family experiences associated with surviving and not surviving~     critical illness. Specifically in this project the investigators will determine the real~     outcomes of critical illness experienced by octogenarians.~   "
134554|NCT01293695|"~     This study is designed to determine the effect of a Hypnosis Intervention on reducing hot~     flash frequency (perceived impact vs. physiologically measured impact), severity and daily~     interference in post-menopausal women. It is felt that the Hypnosis Intervention will result~     in significantly lower hot flash frequency, severity and daily interference scores~     (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.~   "
134555|NCT01293682|"~     This research will examine the effectiveness of calcitriol in treating bone loss in women~     who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected~     to take part in this study. The investigators don't know if bone loss in breast cancer~     survivors should be treated differently than bone loss in other women.~   "
134556|NCT01293669|"~     TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has~     demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the~     oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks,~     numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride~     concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α~     declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987~     could prove beneficial in reducing elevated glucose concentrations in diabetic patients as~     well as in ameliorating organ damage associated with inflammation, oxidative stress and~     hyperglycemia.~   "
134557|NCT01293656|"~     This study is being done to assess the clinical course and treatment options for Crohn's~     Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East,~     and North Africa.~   "
134558|NCT01293643|"~     This is a study to compare the safety and efficacy of the use of a intravaginal ovule~     containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream~     containing a combination Tetracycline and Amphotericin B for the treatment of bacterial~     vaginosis and/or mixed or isolated vaginal candidiasis.~   "
134559|NCT01293630|"~     The primary objective of the study is to determine the maximum tolerated dose (MTD) based on~     the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of~     ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients~     with advanced solid tumors.~      Secondary Objectives:~        -  To assess the overall safety profiles of the combination therapy~        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR~          258063, paclitaxel, and carboplatin when used in combination~        -  To document the objective tumor response~   "
134560|NCT01293617|"~     Berry components have been shown to influence cancer processes in cell culture studies. The~     investigators will conduct a study to investigate if blackberries influence the same cancer~     processes in a human feeding study.~   "
134561|NCT01293604|"~     The objectives of this study are the following: 1) to determine the effect of daily~     consumption of whole grain barley for six week on risk factors of cardiovascular disease~     compared to a diet low in whole grains, and 2) to compare the effects of daily consumption~     of whole grain barley to those of whole grain oats for six weeks to determine if the~     response to these two grains is different.~   "
134563|NCT01293578|"~     The goal of this study is to test the relative merits of a decision aid for diabetes~     medications that we have developed - Diabetes Medication Choice Cards- versus usual care in~     translating comparative effectiveness research (CER) into real world clinics. This study~     will involve about 20 primary care practice sites affiliated with Mayo Health System, Park~     Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo~     Clinic.~   "
134564|NCT01293565|"~     The overall purpose of this study is to learn more about Hypohidrotic Ectodermal Dysplasia~     (HED) and to help in identifying treatment opportunities. Several evaluations will be~     conducted in this study: 1) the number of skin sweat glands you have and their ability to~     produce sweat; 2) your ability to grow hair; 3) the structure of your face compared to faces~     of people affected by HED; 4) molds of your teeth to see if and how they are different than~     people affected by HED.~   "
134565|NCT01293552|"~     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of~     ANT-1207 in the treatment of acne.~   "
134566|NCT01293539|"~     The purpose of this study is to show that chemotherapy delivered directly through the artery~     supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and~     effective treatment alternative to conventional systemic chemotherapy, external beam~     radiation, and surgical removal of the eye.~   "
134567|NCT01293526|"~     The purpose of this study is to correlate the three lead placement (wires that go to the~     heart) possibilities and the responses from the patient's heart. This will be done with the~     help of an echocardiography and SonR signals, which is an external device that is capable of~     detecting sounds created by the heart.~   "
134568|NCT01293513|"~     Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has~     dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients~     are required to take these medications for the rest of their lives. As is well known, the~     prolonged use of such agents is associated with serious, sometimes life-threatening side~     effects, metabolic disturbances such as diabetes and an increased incidence of myocardial~     infarction.~      In 1999, a patient with acute HIV infection was treated soon after diagnosis (Berlin~     patient). However because of intercurrent conditions, treatment was interrupted on two~     occasions. After the third introduction of therapy, treatment was terminated (arbitrarily)~     and the patient was found to have undetectable virus throughout a follow up of approximately~     18 months. The possible explanation of this phenomenon was autovaccination. Other workers~     have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with~     controversial results, possibly because there were too few cycles of treatment interruption.~      In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he~     underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete~     cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal,~     CD4/CD8 ratio remained above 1 and the viral load was undetectable.~      Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with~     HAART for at least one year. Once they have been shown to have undetectable virus (less than~     40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1,~     they can be enrolled in the STI study.~      The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing~     duration treatment interruptions alternating with treatment intervals over a 33 month~     period. Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks.~     During this time the patients will be regularly monitored for clinical events and laboratory~     parameters.~      The purpose of the study is to determine whether patients with acute/primary HIV infection~     undergoing graded STI can achieve a normal immune status and undetectable viral load on a~     long-term basis.~   "
134569|NCT01293500|"~     Recent advances in critical care medicine have dramatically improved morbidity and mortality~     of critical illness. Goal-directed therapy protocols have been instrumental in this change.~     Goal-directed therapy standardizes the rapid delivery of definitive care in illnesses such~     as SIRS (Systemic Inflammatory Response Syndrome) and head trauma. Although this treatment~     approach has been shown to improve clinical outcomes, it has not been widely adopted outside~     academic medical centers. Further improvement in outcomes of critical illness is likely if~     goal-directed therapy is utilized early in the course of care. To facilitate this early~     adoption, goal-directed therapeutic protocols should be developed and implemented by~     specialized pediatric transport teams. The investigators hypothesize that the institution of~     goal-directed therapy during pediatric interfacility transport will improve the outcomes of~     critically ill children.~      The GRIPIT Trial (Goal-directed Resuscitative Interventions during Pediatric Inter-facility~     Transport) will compare outcomes of pediatric SIRS patients before and after the~     implementation of a goal-directed therapeutic protocol during transport. This will be the~     first test of goal-directed therapy in the transport environment. Data will be collected on~     pediatric SIRS patients transported by the Angel One Transport Team at Arkansas Children's~     Hospital before and after protocol implementation. Outcome measures will include length of~     hospital stay, length of intensive care unit (ICU) stay, incidence of multiple organ~     dysfunction syndrome (MODS), and required therapeutic interventions during ICU stay (TISS-28~     scores). In addition, NIRS (Near-Infrared Spectroscopy) monitoring will be used as a~     cerebral and somatic oxygenation trend monitor, to determine its effectiveness as a~     resuscitation guide for pediatric SIRS during transport. NIRS trends are useful as a~     surrogate marker for systemic venous saturations, known to decrease with severe SIRS.~   "
134570|NCT01293487|"~     The purpose of this study is to determine the safety and tolerability of RN564 in women with~     osteopenia and healthy men.~   "
134571|NCT01293474|"~     With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain~     optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal~     thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal~     thickness in glaucoma patients and healthy controls is proposed.~        -  Trial with medical device~   "
134572|NCT01293461|"~     The purpose of this study is to assess safety and tolerability and determine the~     pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of~     CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.~   "
134573|NCT01293448|"~     The purpose of this study is to evaluate a cryoablation technique used to ablate human~     esophageal mucosa.~   "
134574|NCT01293435|"~     This study will collect real-life data from patients with community acquired pneumonia (CAP)~     OR complicated skin and skin structure infections (cSSSI) to assess the burden of the~     disease, review the treatment pathways, evaluate how health resources are used and identify~     any areas of unmet medical needs. The aim of the study is to compare how patients who are~     admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by~     collecting data to understand the patient and disease characteristics, current practice of~     treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10~     European countries.~   "
134575|NCT01293422|"~     This clinical trial is designed to study the effects of pregnane X receptor activator~     rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main~     hypothesis is that rifampicin raises postprandial glucose studied with oral glucose~     tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects~     will be given 600 mg of rifampicin a day for a week. The main outcome measures are the~     changes in the glucose and insulin levels during oral glucose tolerance test.~   "
134616|NCT01292889|"~     The investigators are looking for volunteers who have a history of Major Depressive~     Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not~     have a history of these disorders for a research study on genetics.~   "
134576|NCT01293409|"~     Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective~     disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the~     other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra~     ocular transcranial phototransduction has physiological influences such as changed~     reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a~     randomized, placebo controlled, double blind, dose finding study on the putative effect of~     transcranial bright light in the treatment of SAD.~   "
134577|NCT01293396|"~     The aim of the study is to investigate meal-related treatment with either premixed Insulin~     Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free~     fatty acids excursions after a standard breakfast and lunch.~   "
134578|NCT01293383|"~     The purpose of this trial is to to investigate the safety of LEO 90105 compared with its~     vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male~     subjects.~   "
134579|NCT01293370|"~     The purpose of this study is to explore, through a qualitative approach, how a group of~     people with serious mental illness experienced the integration of a vocational~     rehabilitation intervention during their admittance in hospital.~   "
134580|NCT01293357|"~     The objective of the trial is to investigate skin irritation, phototoxicity and safety of~     LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test)~     in healthy Japanese male subjects.~   "
134581|NCT01293344|"~     The purpose of this study is to document differences between men and women in changes in~     metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric~     controlled nutritional intervention based on the Mediterranean diet in which all foods and~     drinks are provided to subjects. The investigators hypothesize that the decrease in~     LDL-cholesterol will be more important in men than in women.~   "
134582|NCT01293331|"~     The purpose of this study is to detect acute febrile episodes and dengue infection in five~     Latin American countries to assess dengue seroprevalence.~      Primary objectives:~        -  To identify acute febrile episodes among the cohort in order to detect the presence of~          dengue infection.~        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of~          the study.~   "
134583|NCT01293318|"~     The purpose of this study is to investigate if there is an association between copeptin~     level in serum and the severity of pancreatitis and if copeptin can be used as a predictor~     for organ failure and pancreatic necrosis with or without superinfection.~   "
134584|NCT01293305|"~     The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70~     decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the~     therapeutic properties of this association in control of osteoarthritis, especially in~     reducing pain and improving movement. The combination of chondroitin sulfate with~     glucosamine sulfate offers a significantly higher tolerance than most drug treatments and,~     moreover, has long lasting effects even after stopping treatment.~   "
134585|NCT01293292|"~     Previously the approach to treatment of osteoporosis has been to use medications which~     prevent excessive resorption of bone. More recently medications that build up new bone, i.e.~     anabolic treatments, have been, and are being, developed. The investigators would like to~     develop a strategy for evaluating the effectiveness of anabolic therapies by studying a~     currently available therapy (teriparatide). This strategy could then be used to assess new~     anabolic treatments as they are developed for use in humans.~      The aims of this study are 1) to fully describe the changes in bone turnover in response to~     teriparatide by biochemical marker type and by time; 2) to fully describe the changes in~     bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.~      If this study is able to identify an early response to treatment, then this will help speed~     up drug development in this area, by allowing the identification of promising new anabolic~     drugs and enabling us to understand their mechanism of action. This will benefit the~     investigators patients as the investigators will have a better understanding of how these~     drugs work.~   "
134586|NCT01293279|"~     The primary objective of this study is to estimate the distributions of HCV viral/human~     genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA~     gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at~     the time the study is conducted.~   "
134587|NCT01293266|"~     Propofol is routinely used for general anesthesia during pediatric heart catheterisation.~     Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by~     bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is~     regarded as an early warning sign of PRIS. In this study the effect of propofol and~     sevoflurane on serum base excess, pH and lactate are examined during pediatric heart~     catheterisation.~   "
134588|NCT01293253|"~     Many adults find it difficult to perform physical exercise during leisure. The workplace may~     provide an optimal setting to encourage a healthier lifestyle. This study investigates the~     effect of daily stair walking at the workplace on cardiovascular health.~      The main hypothesis is that daily stair walking for 10 weeks compared with a control group~     results in increased aerobic fitness.~   "
134589|NCT01293240|"~     The purpose of this study is to compare the overall performance of a monthly replacement~     contact lens when worn for one month and when worn for two weeks.~   "
134590|NCT01293227|"~     This research project is a multi-year proposal, with the goals of answering and evaluating~     the following:~        1. Does an intramedullary locking device applied in an extra-articular distal radius~          fracture improve post operative pain, diminish hospitalization, improve early return to~          activity and function compared to a volar locked plate?~        2. Does an intramedullary locking device applied in an extra-articular distal radius~          fracture improve patient related outcome measures compared to a volar locked plate?~   "
134591|NCT01293214|"~     Limb transplantation surgery is the transfer of one or more limbs from a deceased human~     donor to a patient with single or multiple limb amputation. Hand transplantation is an~     innovative reconstructive procedure that has the potential to significantly improve the~     lives of hand amputees. The purpose of this study is to develop the best practices for~     multiple limb transplantation that will improve the outcomes of future limb transplant~     recipients.~   "
134937|NCT01288703|"~     The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS~     computerized-adaptive testing in women with urinary incontinence.~   "
134592|NCT01293201|"~     The overall development plan is to show that the combination of tried-and-proven~     decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine~     maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a~     comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of~     symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age~     and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose,~     itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or~     chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the~     favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to~     assess and compare the safety and efficacy of the study drug in a larger group comparatively~     with a placebo control group. Objectives: A) To report and compare total symptom scores~     (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal~     congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study~     period. B) Report any side effects or adverse drug reactions and rate the severity of any~     incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and~     post-nasal drip symptom scores (PND-S) between the two study arms.~   "
134593|NCT01293188|"~     The bioprosthetic aortic valve replacement is a frequent intervention because of the~     predominance of calcified aortic stenosis, which is the most common valvular disease, and~     aging of the population.~      International guidelines recommend anticoagulant therapy during the 3 postoperative months,~     but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the~     low level of evidence available studies and their sometimes conflicting conclusions.~      Questionnaires sent to practitioners have highlighted discrepancies between common practices~     and recommendations.~      However, there is no analysis of actual patterns of postoperative anticoagulation after~     aortic valve replacement with bioprosthesis.~      The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3~     months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers~     French.~   "
134594|NCT01293175|"~     Whole grains (WG) contain numerous physiologically bioactive compounds, a key group being~     polyphenolic compounds such as ferulic acid (FA). These whole grain polyphenolic compounds~     have been shown to have potent antioxidant activity. This study will evaluate~     bioavailability of WG bioactive compounds and their physiological impact on health outcomes,~     mainly related to inflammatory, oxidative and hormonal status, in overweight subjects.~   "
134595|NCT01293162|"~     Cardiovascular risk has been shown to increase with increasing blood pressure values. As a~     consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive~     patients, taking into account that all drugs always have some side effects that can be very~     dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus,~     pharmacological treatment should be delayed until it results really necessary.~      The availability of natural substances with a therapeutic action has modified this scenario~     because of their reduced potential to cause undesirable effects (compared with drugs). In~     order to choose among various nutraceuticals (natural foods compounds with health benefits,~     including the prevention and/or treatment of diseases), preference should be given to those~        -  produced according to the same Good Manufacturing Practice used for drugs, to be sure~          that the finished product has a standard, reproducible composition~        -  for which efficacy and safety in the recommended indications are supported by clinical~          trials.~      An example of a product with these characteristics is Armolipid Plus, a combination of~     nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical~     intervention study showed evidence that treatment with Armolipid Plus leads to a significant~     decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.~      Progress in Research and Development in this field has led to a new patented and registered~     combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with~     antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with~     antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.~      In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev~     has a significant antihypertensive effect, which is beneficial in all those patients with~     high blood pressure values without a defined indication to begin a pharmacological treatment~     according to the current guidelines. The antihypertensive effect of Armolipid Prev,~     documented by ambulatory blood pressure monitoring, in addition to the lowering effect on~     dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and~     early, effective and safe cardiovascular disease prevention.~   "
134596|NCT01293149|"~     Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is~     visualized through a small camera to help diagnose and treat knee problems. This procedure~     is commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly~     completed with a single injection of local anesthetic around the femoral nerve to provide~     pain relief for several hours following knee arthroscopy. The intent of this study is to~     examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade~     in providing children and adolescents post-operative analgesia. The investigators~     hypothesize the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of~     post operative analgesia following arthroscopic knee surgery and reduces post-operative~     opiate requirement.~   "
134597|NCT01293136|"~     This is a retrospective review to evaluate the efficacy of femoral nerve block in providing~     analgesia following reconstructive surgery of the knee and to compare the postoperative~     course of patients who received femoral nerve block with a retrospective cohort who were~     cared for prior to the institution of a regional anesthesia program. The investigators~     hypothesize that femoral nerve blockade limits postoperative opioid needs, improves~     analgesia and facilitates discharge home when compared to intravenous opioid use following~     reconstructive knee surgery.~   "
134598|NCT01293123|"~     The primary aim of this study is to determine the effects of the HIV integrase inhibitor,~     raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF~     before and after initiation of either raltegravir or another antiretroviral, efavirenz, each~     in combination with two other antiretrovirals. Assessments will include HIV RNA levels~     (viral load), neuropsychological testing, mood assessments, and quality of life assessments.~   "
134599|NCT01293110|"~     Patients with neurological disease/injury often suffer from lower urinary tract symptoms,~     which frequently have a negative impact on the patients' health related quality of life. The~     prevalence of lower urinary tract dysfunction is high and the treatment is a challenge~     because available treatments may fail. In this study data of patients with lower urinary~     tract dysfunction treated at the University of Zürich, are prospectively and systematically~     collected in a database.~   "
134600|NCT01293097|"~     This randomized, open label, controlled, parallel group study is designed to test whether~     2-day high dose atorvastatin administration before PCI and 30-day continuous intensive~     atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular~     events, as well as 6-month prognosis. The goal is to set up an optimized protocol for~     peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.~   "
134601|NCT01293084|"~     Previously, the investigators and others have shown that mucociliary clearance (MCC) is~     defective in patients with cystic fibrosis (CF) and it is now thought that alterations in~     airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by~     trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing~     the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in~     the airways, and this in turn is associated with acute infections, chronic bacterial~     colonization and chronic inflammation. One treatment strategy that is gaining acceptance as~     an important therapy for improving MCC in adults with CF is the inhalation of the osmotic~     stimulus, hypertonic saline (HS). A number of studies have shown that acute inhalation of HS~     (7% saline) significantly improves MCC in adults with CF and results from a recent study~     indicate that two weeks of inhaling HS leads to a significant increase in MCC that is~     sustained for 8 hours post inhalation and is associated with significant improvements in~     FEV1, FVC and FEF25-75 values. Since MCC in patients with CF appears to be impaired by~     adulthood, any drug that disrupts or slows the impairment in childhood could prove~     enormously beneficial in the long-term prognosis of the disease. Nevertheless, no studies~     have been conducted to determine if HS treatment improves MCC in children with CF. This is~     most problematic for physicians who care for children with CF who have normal FEV1 and FVC~     values, since it is unclear if they should treat these children with HS or not. This~     research study is designed to begin to answer this question. The investigators hypothesize~     that acute inhalation of hypertonic saline (7%) will improve MCC in CF children with normal~     pulmonary function. Our hypothesis will be tested in a one-year clinical trial that will be~     randomized and placebo-controlled. Twelve children with CF who are 7-12 years old and have~     normal FEV1 and FVC values will participate. Our goal will be to compare MCC in these~     children on two study visits after acute inhalations of placebo (0.12% saline) or hypertonic~     saline (HS) (7% saline) aerosol. The investigators predict that MCC values after acute~     inhalation of 7% HS aerosol will be statistically significantly greater than after placebo~     inhalation.~   "
134602|NCT01293071|"~     The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of~     antibiotic resistant Gram-negative colonisation.~   "
134603|NCT01293058|"~     The purpose of this study is to determine which route of administration is better for~     treatment of opioid overdosed patients~   "
134604|NCT01293045|"~     -  Preliminary scientific studies, in both animals and humans suggest that oral~          consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating~          the activity of osteoblasts responsible for bone formation while improving the bone~          mineral density and biomechanical resistance of long bones.~        -  The objective of this clinical research is to measure changes in biomarkers of bone~          turnover in postmenopausal healthy women, not osteoporotic, in response to consumption~          of hydrolyzed collagen for three months.~        -  For this, we propose to measure blood and urinary markers of formation and bone~          resorption before consumption, then 45 and 90 days after daily consumption of 10 g of~          hydrolyzed collagen.~   "
134605|NCT01293032|"~     This randomized pilot clinical trial studied whether the Oncotype DX gene expression~     Recurrence Score (RS) would be useful for helping make a decision about which type of~     pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with~     hormone responsive cancers that were not suitable for breast conserving surgery. The RS is~     currently used to predict the risk of distant recurrence and the benefit of the addition of~     chemotherapy to hormonal therapy in the adjuvant setting.~   "
134606|NCT01293019|"~     To study the contribution of osteopathy on the reduction of pain in adult patients with~     cystic fibrosis~   "
134607|NCT01293006|"~     This study will evaluate the safety, tolerability, and effect of multiple doses of~     suvorexant (MK-4305) on respiratory function in participants with chronic obstructive~     pulmonary disease (COPD). This is a crossover study, so all participants will receive both~     suvorexant and placebo while on study. The primary hypothesis of this study is that multiple~     doses of suvorexant do not produce a clinically significant reduction of mean oxygen~     saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.~   "
134608|NCT01292993|"~     The purpose of this study is to determine the effects of LX4211 and metformin on each other~     when given at the same time as single doses to healthy human subjects.~   "
134609|NCT01292980|"~     Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony~     prominence of their body, which is expected to break down into a pressure ulcer) will be~     place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the~     amount of tissue breakdown from their bruise.~   "
134610|NCT01292967|"~     The primary propose of this study is to determine the impact of ingredients and matrices on~     flavanol absorption and metabolism.~   "
134611|NCT01292954|"~     Scientific question to be addressed: To determine the effects of acute blueberry ingestion~     on vascular function and blood pressure in humans~      Hypothesis: Acute consumption of blueberry induces an improvement in blood pressure and~     vascular function through the impact of blueberry flavonoids on the vascular system.~      Study objectives: To determine the dose-dependency of a blueberry drink on blood pressure~     and vascular function in healthy subjects and to determine pharmacokinetics of blueberry~     polyphenols~   "
134612|NCT01292941|"~     To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)~   "
134613|NCT01292928|"~     The primary objective of this clinical study is to determine whether the Innova Stent System~     shows acceptable performance in long-term (12-month) safety rates and vessel patency when~     treating femoropopliteal lesions.~   "
134614|NCT01292915|"~     The main aim of the study is to describes the outcomes of patients with Upper~     Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed~     predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic~     therapies.~   "
134615|NCT01292902|"~     Inspiratory muscle dysfunction is a reduction in the ability to generate pressure and force~     by the inspiratory muscles. This decrease in the strength of these muscles can be attributed~     to biochemical and histological changes. Some patients with CHF showed a reduction of~     maximal inspiratory pressure (MIP) and inspiratory muscle endurance, and such factors known~     to exercise limitation and deterioration in quality of life and worsens the prognosis of~     these patients. This study aims to evaluate the Regional pulmonary distribution volume and~     the influence of enclosures system thoracoabdominal in CHF patients with cardiomegaly~     associated with diaphragmatic weakness during quiet breathing and during exercise for~     inspiratory muscle and its correlation with functional data. The investigators evaluated a~     total of 31 individuals divided into two groups: CHF and control. In the control group,~     twelve volunteers participated with similar age, gender and body mass index in relation to~     the group of patients with CHF. The control group participants had an ejection fraction of~     left ventricle (EF)> 50% without cardiac abnormalities of the cameras and MIP over 80% of~     predicted. To conduct the exercise to the inspiratory muscles (EMI) was used for IMT~     Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar~     Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients~     with several pathologies such as CHF. The exercise time was 3 minutes. During this period,~     participants were encouraged to only breathe through the mouth and maintain a respiratory~     rate between 12 and 16ipm. Opto-electronic plethysmography measures the volume changes of~     thoracoabdominal system by placing 89 markers formed by hemiesferas covered with~     retro-reflective paper, taking the place of each of these hemiesferas determined by~     anatomical landmarks on the anterior and posterior regions of the chest and abdomen.~     According to our study, a lower ventilation on diaphragmatic region would lead to an~     increased perception of dyspnea during submaximal exercise in this population. Moreover, the~     observed changes in the pattern of regional distribution of ventilation in CHF patients~     compared to healthy individuals can serve as a basis for prospective cohort studies using~     IMT.~   "
134617|NCT01292876|"~     The objective of the study is to assess mechanical strength and function in subjects~     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of~     biologic scaffolds for the restoration of both mechanical strength and function in these~     subjects. This study will formally evaluate healing and return of function after an~     extracellular matrix device implantation in 40 male and female subjects participating at the~     University of Pittsburgh under the Department of Plastic and Reconstructive Surgery who~     suffer from injury with loss of skeletal muscle tissue.~   "
134618|NCT01292863|"~     The purpose of this study is to evaluate the impact of Delflex neutral pH (a biocompatible~     peritoneal dialysis solution) on mesothelial cell viability and peritoneal transport.~   "
134619|NCT01292850|"~     The aim of this study is to investigate sterility of ethyl-chloride topical anesthetic spray~     when used prior to an injection. The hypothesis is that the spray does not change the~     sterility of the injection site after skin is prepped.~   "
134620|NCT01292837|"~     To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day~     or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16~     years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or~     2 Anti-Epileptic Drugs (AEDs).~   "
134621|NCT01292824|"~     This is a phase I pilot study to determine the safety and preliminary efficacy of a novel~     hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing~     liver transplantation.~   "
134622|NCT01292811|"~     The objective of this research program is to conduct a multi-site clinical randomized~     control trial that will evaluate the efficacy of functional electrical stimulation based~     upper limb intervention for people with tetraplegia. This will involve recruiting 84 persons~     with sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton)~     and will serve to evaluate three new Canadian hand function assessments that have been~     specifically developed for persons with tetraplegia. Although these assessments have been~     recently tested and have shown considerable promise, further evaluation on their clinical~     utility (in particular their responsiveness and validity) is required. As well, they need to~     be compared with one another to determine whether any of these tests is more appropriate for~     clinical applications or whether further test reduction or augmentation may be required.~     Having measures that are sensitive and accurate in assessing hand function is key for~     systematically evaluating emerging therapeutic interventions.~   "
134623|NCT01292798|"~     This is an open-label, Phase I/II study of intravitreally administered ranibizumab either~     0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence~     tomography (OCT) evidence of diabetic retinopathy with associated diabetic macular edema~     following bevacizumab therapy. Thirty patients will be enrolled in this study.~      Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5~     mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory~     treatment phase (Day 0, Month 1, and Month 2).~      Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections~     of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat~     recurrent macular edema for an additional 9 months (12 months from Day 0). The intent is to~     administer additional ranibizumab treatment if there is evidence of disease activity~     documented on OCT (e.g., intra-retinal fluid, subretinal fluid and/or cystic changes).~      Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg~     ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered~     every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits.~      Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular~     edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary~     with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6~     months (12 months from Day 0).~      Subjects with residual diabetic macular edema following 3 consecutive intravitreal~     injections of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to~     treat persistent or recurrent macular edema for an additional 6 months (12 months from Day~     0). Focal photocoagulation or intravitreal triamcinolone may be administered at the~     physician's discretion as an adjunct to ranibizumab injections beginning at Month 6 through~     Month 12 of the study.~      All subjects will make monthly visits for 12 months for evaluation of safety and efficacy.~     All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety~     visit one week (±2 days) after the first injection. At subsequent visits, the subject will~     have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal~     injection. Subjects will be contacted by the site personnel 1-2 days after each injection to~     elicit reports of decreased vision or pain or unusual new ocular symptoms in the study eye.~   "
134624|NCT01292785|"~     This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain~     function and structure induced by long-term opposite-sex steroid hormone administration in~     transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term~     opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to~     investigate the influence of hormone treatment on resting state functional connectivity and~     brain morphology. 3. to investigate differences between transsexuals and healthy control~     subjects in brain function and functional connectivity, brain morphology and structural~     connectivity. In this longitudinal study, transsexuals and healthy control subjects will~     undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone~     treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.~   "
134625|NCT01292772|"~     The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant~     radiation therapy on reconstructed breasts.~   "
134626|NCT01292759|"~     Cardiac output can be monitored using different invasive devices. Nexfin HD is a new,~     noninvasive device that uses model flow technology to measure stroke volume and thus~     computes cardiac output (CO). To evaluate this new device the investigators compared~     esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.~   "
134627|NCT01292746|"~     The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low~     level laser light device can help to regrow hair on the scalp of females experiencing hair~     loss or thinning.~   "
134628|NCT01292733|"~     The main purpose of this program is to see whether periodically measuring CA-125 (tumor~     marker) levels in the blood and undergoing transvaginal ultrasounds over time will be~     effective in the early detection of ovarian cancer.~   "
134629|NCT01292720|"~     In cross-sectional and prospective cohort studies, vitamin D deficiency is associated with~     increased mortality, cardiovascular events including sudden cardiac death and stroke,~     diabetes, hypertension and impaired function of the immune and musculoskeletal system. The~     action of vitamin D on the cardiovascular system regulates cardiac function, endothelial and~     vascular smooth muscle, and, the renin-angiotensin system. Treatment with sufficiently high~     doses of vitamin D may represent a promising and inexpensive intervention option. To date,~     there are few data on the effect of cholecalciferol treatment in patients with chronic heart~     failure. The primary objective of this study is to investigate whether oral vitamin D~     supplementation improves chronic heart failure (measured with the surrogate parameter of~     NT-proBNP levels at month 0 and 6).~   "
134688|NCT01291953|"~     To verify if the screening opportunistic of Atrial Fibrillation (AF) by means of the~     measurement of the arterial peripheral pulse is more effective than the habitual practice~     for the early detection of AF in 65-year-old who come to Primary care~   "
134630|NCT01292707|"~     Background.~      Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation~     that is unsustainable given the relatively high cost of artemisinin combination therapy~     (ACTs) compared to older antimalarials. In addition it often denies patients treatment for~     their actual illness and generates unreliable data for health planners. For these reasons~     the National Malaria Control Programme introduced revised guidelines for malaria diagnosis~     and treatment in 2006 restricting the recommendation for antimalarial treatment in patients~     over the age of 5 years to those with a positive blood slide or malaria rapid diagnostic~     tests (RDTs) result. To support this, RDTs will be introduced into primary care health~     facilities in Tanzania starting in 2009.~      The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a~     cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised~     guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful~     unless accompanied by unsustainable levels of supervision and training.~      Primary objective.~      To conduct a trial of interventions directed at prescribers or prescribers and communities~     compared to control groups to improve adherence to national guidelines for prescription of~     antimalarial treatment when supported by RDTs in primary health care facilities in NE~     Tanzania.~      Methods~      All 60 participating health facilities will receive RDTs and basic training in their use and~     a copy of current NMCP/MOH guidelines for each prescribing staff member. A health worker~     intervention arm will, in addition, receive workplace-based interactive training and~     messages from senior staff A health worker-community arm will receive the same training as~     the health worker arm and in addition leaflets will be provided to RDT-tested patients~     providing information on the test and the treatment given. All training materials will be~     approved by NMCP in Tanzania as being consistent with current national guidelines but with~     the addition that prescribers will be asked to follow RDT results in prescribing for~     patients of any age This policy is in line with the most recent revision to WHO guidelines~     and is supported by NMCP in Tanzania.~      Study outcomes will be recorded through a 40% (2 days per week) exit survey of patients.~     Anthropological and economics studies will assess the costs and acceptability of~     interventions.~   "
134631|NCT01292694|"~     The purpose of this study is to test the hypothesis that angiotensin II plays a role in the~     supine hypertension of primary autonomic failure. To determine the contribution of~     angiotensin II to renin and blood pressure regulation in autonomic failure, patients with~     multiple system atrophy [MSA] or pure autonomic failure [PAF] and supine hypertension will~     undergo medication testing with the angiotensin II receptor blocker losartan. The~     investigators will compare the biochemical and hemodynamic effects between MSA and PAF~     patients. In a subset of patients, the investigators will also give the ACE inhibitor~     captopril. Our primary endpoint will be changes in plasma renin activity, and subsequent~     components of the circulating renin-angiotensin system, in response to angiotensin II~     blockade. Our secondary outcome will be changes in hemodynamic measures during~     administration of these drugs.~   "
134632|NCT01292681|"~     Because of metastatic liver cancer of the colon or rectum, patients will be treated with~     cytotoxic drugs (chemotherapy). In the Radboud University Nijmegen Medical Centre the~     investigators investigate whether the imaging techniques at an early stage of treatment can~     predict which patients will have benefited from this treatment.~      In the study the investigators use two different scanners: a MR (magnetic resonance) scanner~     and a PET (Positron Emission Tomography) scanner combined with a CT (Computer Tomography)~     scanner. An MR scanner is a large magnet and looks like a CT scanner which also makes~     pictures. But instead of using X-rays the recordings are made with magnetic fields. The scan~     consists of a table on which the patient will lie with the head in a half-dome with a~     camera. The examination with the MR scan is not painful and not harmful.~      The PET scan is a type of CT scan that makes (after administration of a radioactive liquid),~     a scan of (part of) the body. The amount of radioactivity that is used for the study is so~     small that it will not have an adverse impact on the patient. This research is two times~     combined with a''normal''CT scan.~      Using the MR scan, the investigators can research the oxygensupply, the aggressiveness of~     the tumour and the degree of liver metastases that die from the chemotherapy . The~     investigators can also, after administration of a MR contrast agent, investigate the blood~     supply of a tumor through imaging. If you are treated with the chemotherapeutic drug~     capecitabine the investigators can monitor the intake of this agent in the liver metastases.~     The PET CT scan tells us more about the metabolism in the liver metastases.~   "
134633|NCT01292668|"~     RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a~     certain kind of light. When the drug is active, cancer cells are killed. Photodynamic~     therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin~     cancer. PURPOSE: This phase I trial is studying the side effects and best dose of~     photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain~     threshold patients with skin cancer~   "
134634|NCT01292655|"~     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects~     with advanced or metastatic solid tumors who no longer respond to or have relapsed from~     standard therapies.~   "
134635|NCT01292642|"~     The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to~     develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim~     to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent~     marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT~     intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a~     transdermal nicotine patch, will reduce the use of marijuana and nicotine.~   "
134636|NCT01292629|"~     The purpose of this multi-center clinical trail is to determine the safety and efficacy of~     the iSert 251 for the correction of aphakia.~   "
134637|NCT01292616|"~     Atlantoaxial subluxation (AAS) is a complication of rheumatoid arthritis (RA) due to pannus~     formation around the odontoid process of C2 of the cervical spine. It occurs frequently in~     15-30% of all RA patients. AAS may occur relatively early in the course of disease within~     the first years. The diagnosis of AAS identifies a patient population with a poor outcome.~     There is evidence that combination treatment with disease-modifying anti-rheumatic drugs~     (DMARD) may retard the development of AAS. However, it is not known whether treatment with~     inhibitors of tumor necrosis factor alpha (TNF) may lead to regression of cervical pannus~     and prevention or reduction of AAS.~      Clinical studies analysing the effectiveness of TNF-inhibitors combined with conventional~     DMARD therapy, in the treatment of cervical spine involvement leading to AAS, are needed.~     This proposal for a pilot study aims at assessing the feasibility of an MRI-based~     measurement of pannus volume in patients before and after treatment with a TNF-inhibitor.~      Primary objective: To show that measurements of pannus mass with MRI is feasible. Secondary~     objective: To assess whether pannus mass decreases measurably in patients treated with~     TNF-inhibitors.~      This pilot study is prospective, non-randomized. The choice of therapy at any time during~     the study is entirely up to the treating rheumatologist.~   "
134765|NCT01290952|"~     Compare completeness and modality of revascularization, operative and postoperative results~     and 1 year clinical outcomes in unselected high risk patients referred for primary coronary~     artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery~     bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).~   "
134638|NCT01292603|"~     This randomized, parallel-group, multi-center study will compare the pharmacokinetics and~     safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in~     combination with chemotherapy in previously untreated patients with chronic lymphocytic~     leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously~     received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and~     in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6~     cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of~     subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and~     cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug~     is 24 weeks.~   "
134639|NCT01292590|"~     The purpose of this study is to determine if dietary fat alters insulin requirements in type~     1 diabetes.~   "
134640|NCT01292577|"~     This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy~     [CET]) and an affect regulation (Personal Therapy [PT]) intervention for 50 individuals with~     schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment~     as usual (TAU) or TAU alone and treated for 18 months.~   "
134641|NCT01292564|"~     The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous~     fat across the waist and hips that occurs through application of the Erchonia® ML Scanner~     (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.~   "
134642|NCT01292551|"~     The purpose of this study is to determine whether Bosentan is an effective and safe~     treatment to adolescent and adult (15 years and older) patients, born with one ventricle of~     the heart instead of two (single ventricle physiology) and who have undergone TCPC as a~     palliative surgical treatment. The aim of the TCPC operation is to use the one functioning~     ventricle to pump the blood flow to the body, while the blood to the lungs is received~     directly from the caval veins, and is thus a passive flow, without the aid of a ventricle to~     actively pump the blood through the pulmonary circulation. The resistance in the pulmonary~     circulation is therefore critical to these patients. These patients have markedly lower work~     capacity in bicycle test than the general public. Furthermore they have a high risk of~     developing complications e.g. loss of protein from the intestines.~      Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is~     routinely used for patients with pulmonary hypertension. Some studies have shown that drugs~     that lower the pulmonary resistance can increase exercise capacity significantly in patients~     with single ventricle physiology.~      In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and~     after the treatment, bicycle test along with blood samples, stool samples and quality of~     life interviews will be performed. Every four weeks during the study blood samples, physical~     exam and interviews will be performed to ensure the safety of the treatment.~      The investigators expect to find a significant increase in work capacity after 14 weeks in~     the treatment group compared with the placebo group.~      Moreover the investigators hope to find a decrease in intestinal protein loss and an~     improved quality of life.~   "
134643|NCT01292538|"~     The purpose of this study is to determine if 532nm green diode laser light is effective in~     body contouring of the waist, hips and thighs.~   "
134644|NCT01292525|"~     The main objective of this study is to demonstrate the benefit of the withdrawal of~     Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning~     period. The secondary objectives will focus on assessing the risks and consequences of~     withdrawal of Tacrolimus (Prograf®).~   "
134645|NCT01292512|"~     This study aims to develop a risk assessment tool to identify bereaved in risk of~     complicated grief reactions and to implement a bereavement management programme in primary~     health care based on the Dual Process Model of coping with bereavement. Furthermore to~     enhance bereavement care in general practice and to enhance patients' self-management in~     bereavement care.~   "
134646|NCT01292499|"~     The RIMAT‐De study (Rete Italiana per il Miglioramento dell'Adesione al Trattamento nella~     Depressione) is a multicentric Randomized Controlled Clinical Trial aiming at identifying~     the best strategies available to reduce the poor compliance of patients with antidepressant~     drugs. Patients' compliance will be measured within six months of pharmacological treatment,~     comparing the specific contributions of brief psychotherapy and psychoeducational~     interventions: the psychoeducational intervention will encompass the monitoring of drugs'~     side effects and patients' satisfaction. In the rest of the document, for the sake of~     brevity the two treatments previously described will be indicated as psychotherapy and~     psychoeducation. These treatments will be compared with the treatment usually carried on~     by the mental health centers involved (i.e. treatment as usual, TAU). The factorial design~     of the study will take into consideration the combination of the two treatments (i.e.~     psychotherapy and psychoeducation) as well.~   "
134647|NCT01292486|"~     The purpose of this investigation is to establish that hematopoetic stem cells collected on~     a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to~     reconstitute the hematopoetic systems of patients treated with myeloablative therapy,~     equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.~   "
134648|NCT01292473|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite~     standard-dosed H1 antihistamine treatment.~   "
134649|NCT01292460|"~     The purpose of this study is to compare the efficacy and safety of the preservative-free~     fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study~     will enroll patients who have ocular hypertension or glaucoma and who are using timolol or~     prostaglandin.~      The study medication period is 6 months, but the primary evaluation of efficacy is done at 3~     months.~   "
134699|NCT01291810|"~     The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II~     clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of~     clinical efficacy are promising.~      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in~     subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to~     anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune~     responses and the safety elicited by TNF-K will also be evaluated.~   "
134650|NCT01292447|"~     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive~     that may be underutilized due to fear of pain during insertion. Although providers~     frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there~     is no evidence for any pain reduction. In fact, no interventions evaluated in randomized~     controlled trials have been shown to be effective in reducing pain during IUD insertion.~     While many women tolerate IUD insertion well, others have moderate to severe pain. This~     double-blind randomized controlled trial of 150 women aims to estimate the efficacy of~     intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain.~     Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion~     will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be~     able to detect a 15 mm difference on the VAS with our sample size. Other data to be~     collected include information regarding age, BMI, obstetric history, lactation status, time~     since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety~     levels, anticipated pain levels, insertion characteristics (time, difficulty,~     complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is~     effective, then a viable, easily administered option for pain control will be available to~     providers and patients.~   "
134651|NCT01292434|"~     Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole~     grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks~     of parent handouts, classroom activities related to topics in the handouts, parent and child~     activities to reinforce behavioral constructs, and a one week booster 22 weeks later.~      The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables,~     and whole grains in sack lunches. Additional hypotheses are that lunches at child care~     centers where the program is used will have higher dietary quality than centers without the~     program and that children at the centers where the program is used will have a smaller~     increase in body mass index than children at centers with the program.~      The study will also look at the child's home environment and the childcare center.~     Hypotheses for this research question include~        1. Children at centers with Lunch is in the Bag will have greater frequency of eating~          fruits, vegetables, and whole grains at home than those at centers without the program.~        2. Compared to parents at centers without the program, parents of children at centers with~          Lunch is in the Bag will have~             1. Greater knowledge, expected benefits, support, intentions, and belief in their~               ability for packing fruit, vegetables, and whole grain in their child's sack lunch~               daily.~             2. Availability of fruit, vegetable, and whole grain in the home pantry.~             3. Number of lunches with temperature in the safe range at time of service.~   "
134652|NCT01292421|"~     RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune~     response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg~     vaccine therapy in healthy participants who have undergone previous vaccination.~   "
134653|NCT01292408|"~     Hydroxychloroquine is a drug that has been used to treat malaria and rheumatism. It is~     recently discovered that Hydroxychloroquine increases 'autophagy'. Autophagy is a process~     whereby cells eat a part themselves giving them extra energy. Cancer cells use autophagy to~     survive chemotherapy or hormonal therapy. Also, cancer cells use autophagy to survive in~     areas of a tumor where there is a low oxygen level.~      The purpose of this study is to determine whether treatment with the drug Hydroxychloroquine~     leads to a decrease of autophagy in breast cancer tissue.~   "
134654|NCT01292395|"~     Military personnel face many physiological challenges, including sustained physical activity~     and prolonged periods of negative energy balance. Chronic energy deficiency often results in~     a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests~     that dietary interventions that provide protein in excess of the current national dietary~     recommendation may confer protection against the negative effects of energy deficiency on~     the musculoskeletal system. The primary objective of this randomized, controlled study is to~     assess the effects dietary protein intake spanning the current acceptable macronutrient~     distribution range on musculoskeletal health following prolonged energy deficiency. Findings~     from this investigation will improve current understanding of dietary conditions necessary~     to reduce the damaging effects of caloric deficiency on musculoskeletal health in~     warfighters. Furthermore, given the rise in obesity in military populations, findings may~     aid in the development of nutritional weight management strategies that promote healthy~     weight loss without compromising musculoskeletal health.~   "
134655|NCT01292382|"~     Memory is constituted by a set of mental abilities of information processing that will be~     available at a later time. Flawless performance depends on several brain systems and other~     cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the~     production capacity and quality of life. Such deficits represent variations of normal , and~     may stabilize,or even better progress. Include multiple cognitive domains, such as working~     and episodic memory, and attention. Despite the heterogeneity of the nature and severity of~     these deficits, common characteristics were observed in neuropsychological assessment of~     that population, for example, reduction in processing speed. There is an important gap in~     the therapeutic approach of these individuals.~      Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with~     potential to improve memory and cognition activating networks that operate on memory or~     other networks that interfere with cognitive performance. The technique relies on generating~     a variable magnetic field originated from an alternating electric current applied to the~     human skull reaching focal cortical regions.~      This study is a sham-controlled clinical trial, randomized, double-blind study. It will be~     evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global~     cognition (memory, attention, language, executive functions, planning, logical reasoning,~     calculation and visual-spatial perception), especially memory, of elderly individuals with~     mild cognitive impairment, included in the domain of cognitive impairment no dementia~     (CIND).~   "
134656|NCT01292369|"~     The concept of breath testing for various diseases has been around since ancient greece. It~     has been hypothesized that cancer is generating a unique pattern of compounds in patients'~     breath. This study is trying to characterize a novel system, based on nanoparticles~     technology, for cancer diagnosis through breath samples.~   "
136479|NCT01268566|"~     The primary objective of this Phase II study is to evaluate the progression-free survival at~     6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are~     treated with MEDI-575.~   "
134657|NCT01292356|"~     Colon cancer is one of the most common cancers in France with more than 36,000 new cases per~     year. Despite significant advances in therapeutic care, the prognosis of colon cancers with~     metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled~     with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor~     Receptor), which allowed a significant increase in patient survival. They are responsible~     for skin toxicity in the form of an acneiform rash which can be debilitating for patients~     and require discontinuation of treatment. However, this toxicity is strongly correlated with~     treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is~     therefore a major challenge to treat and better understand the association with treatment~     efficacy.~      The objective of this study is to investigate a link between cutaneous inflammatory response~     in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will~     be conducted systematic consultations dermatology, skin biopsies and blood samples in~     patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of~     inflammatory cells and expression of genes involved in skin inflammation.~   "
134658|NCT01292343|"~     Triclosan containing dentifrices are effective in the prevention of inflammatory~     complications following third molar surgery through reducing preoperative oral bacteria~     load.~   "
134659|NCT01292330|"~     Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After~     Preoperative Nutritional Support.~      Study design:~      1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from~     Peking Union Medical College Hospital (PUMCH).~      Study arrangement:~        1. The collection of patients with selected standard~        2. Preoperative evaluation included nutritional status,liver function and tumor~          characteristics~        3. The experimental group received Preoperative Nutritional Support for 4 days,the control~          group got nothing~        4. Both groups received conventional therapy after operation~        5. The comparation of the clinical outcomes in both groups~   "
134660|NCT01292317|"~     Introduction:~      Patients with pre-existing impaired renal function are prone to develop acute contrast media~     induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new~     biomarker predictive for acute renal injury has been shown to be capable for earlier~     diagnosis of acute contrast media induced nephropathy (CIN) in patients undergoing cardiac~     surgery.~      Intravenous volume load is a widely accepted prophylaxis.~      In this randomized and controlled study, only patients with the need for an intra-arterial~     contrast media (CM) application will be included and receive a standardized, weight-based,~     intravenous hydration before investigation.~      It is the aim of this study:~        1. to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN)~          following intra-arterial angiography in a well defined group of high-risk patients.~        2. to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor~          of contrast media induced nephropathy (CIN) after contrast media (CM) application.~        3. to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared~          to only pre-procedural volume expansion.~      Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL)~     after investigation will be randomized into one of two study groups:~      Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid~     intake.~      Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for~     6 hours.~      Endpoints:~      Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater~     than 25% of baseline serum creatinine.~      Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement~     therapy, death.~   "
134661|NCT01292304|"~     Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites~     in liver cirrhosis. Tolvaptan will be administered in combination with current ascites~     management.~   "
134662|NCT01292291|"~     RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find~     prostate cancer and learn the extent of disease.~      PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in~     diagnosing prostate cancer.~   "
134663|NCT01292278|"~     Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid~     hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and~     blood (serum) and the neurological outcome in the acute stage of aSAH.~   "
134664|NCT01292265|"~     To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment~     period measured by Power/Color Doppler and Gray scale Ultrasound.~   "
134665|NCT01292252|"~     The purpose of this study is to determine the effects of 12 weeks of daily treatment with~     teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral~     spine fusion surgery for degenerative conditions of the lumbar spine.~   "
134666|NCT01292239|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with~     placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in~     treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.~   "
134667|NCT01292226|"~     This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic~     parameters of CellCept in patients undergoing primary kidney transplantation, in order to~     assess the impact on clinical outcome and the risks of acute rejection. All patients will~     receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters~     will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24~     weeks.~   "
134668|NCT01292213|"~     The purpose of this study is to investigate the role of Haemophilus influenzae and other~     bacteria in causing chronic cough, through a direct comparison of chronic cough cases and~     healthy controls recruited from paediatric respiratory clinics in the United Kingdom.~   "
134669|NCT01292200|"~     This four-and-a-half-year study will test the efficacy of viewing a theoretically based and~     culturally sensitive video followed by group discussion (vs. single viewing) in increasing~     mammography use. The results of this study will lead cancer control efforts to effectively~     decrease breast cancer screening disparities experienced by Chinese-America women.~   "
134670|NCT01292187|"~     The primary purpose of this study was to evaluate the efficacy of oral calcitonin~     (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral~     density at increased risk of fracture. The secondary purpose of this study was to determine~     if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets~     administered at dinner or at bedtime.~   "
134671|NCT01292174|"~     The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially~     increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the~     administration of four total injections of ibalizumab or matching placebo in each volunteer,~     given once every week, at one of three dose levels. Drug administration begins at the lowest~     dose. After 4 of 8 volunteers in the first group have received all study drug injections and~     have completed 6 additional weeks of follow-up, an independent safety monitoring group will~     review available data before approving initiation of the next higher dose-group. This~     process will be repeated prior to initiation of the 3rd and highest dose-group.~      All volunteers will participate in 2 separate intensive blood sampling periods of 7 days~     each to test drug levels.~   "
134672|NCT01292161|"~     The purpose of this study is to determine the effects of silymarin on outcomes of patients~     with hepatitis C.~   "
134673|NCT01292148|"~     The purpose of this study is to determine that the measurements of rectal and bladder~     temperature are correctly consistent with core temperature by using the pulmonary artery~     catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming~     phase.~   "
134674|NCT01292135|"~     The purpose of this study is to establish the safety of orally administered PCI-32765 in~     combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab~     (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).~   "
134675|NCT01292122|"~     The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft~     (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated~     donor site.~   "
134676|NCT01292109|"~     The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical~     practice.~   "
134677|NCT01292096|"~     Patients with frequent hospital admissions account for a disproportionate share of visits~     and costs. An intervention that can bridge the gap between hospital and community based care~     for a population of patients with frequent hospital admissions may offer both improved care~     and cost savings if hospital admissions can be appropriately reduced. We are now using data~     from our previous research to inform the development and implementation of an intervention~     at Bellevue Hospital, which will bridge the gap between hospital and community based care~     for a population of patients with frequent hospital admissions.~      We hypothesize that such an intervention can offer both improved care and cost savings if~     hospital admissions can be appropriately reduced.~      In this protocol we outline a strategy to pilot a small-scale intervention on a small subset~     of patients admitted to an urban public tertiary care safety net hospital who are defined by~     our study criteria as at high risk for future readmission. By piloting components of the~     intervention, we aim to assure the intervention functions as planned, and can deliver the~     needed services to high risk patients in a seamless and patient-centered manner. The purpose~     of this feasibility study is to ensure that when our intervention is implemented on a~     larger scale, it appropriately serves enrolled patients needs, and that we are able to~     effectively follow patients during the intervention period.~   "
134678|NCT01292083|"~     This clinical trial studies azacitidine in treating patients with triple negative stage I-IV~     invasive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as~     azacitidine, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
134679|NCT01292070|"~     The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD)~     is able to block the skin reaction to cat allergen in cat allergic subjects compared to the~     skin reaction to cat allergen alone. This research project is also testing the safety and~     tolerability of this new, experimental treatment, compared to the current treatment of cat~     allergen alone.~   "
134680|NCT01292057|"~     The purpose of this study is to determine whether aripiprazole (marketed dopamine~     stabilizer) is effective in reducing of alcohol craving and drinking compared to placebo~     depending on participant's baseline level of impulsivity.~   "
134681|NCT01292044|"~     The primary objective of this study is to evaluate the role of elastography (along with~     echographic and cytological data) as a diagnostic tool for thyroid cancer~   "
134682|NCT01292031|"~     1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of~          VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days~          and clinical healing in patients clinically evaluated.~        2. To compare the safety of treatment with colistin vs meropenem in VAP.~        3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP~   "
134683|NCT01292018|"~     The purpose of study to assess the control of dyslipidemia in the Indian diabetic population~     treated with any hypolipidemic agent.~   "
134684|NCT01292005|"~     The purpose of this study is to determine the effects (good and bad) of giving a drug called~     pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests~     associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and~     Drug Administration (FDA) for treatment of circulation problems, but its use in this study~     is investigational, which means that the FDA has not approved it for the treatment of~     pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.~   "
134685|NCT01291992|"~     The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac~     surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.~   "
134686|NCT01291979|"~     This prospective randomized study aims to evaluate the effectiveness of intravenous~     lidocaine injection on the relief of pain in patients undergoing tonsillectomy.~      A total of 62 patients will be randomized into one of two groups (group C or group I) based~     on Excel number generation.~      Patients in group C will receive received normal saline intravenous injection, and patients~     in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a~     continuous lidocaine infusion of 2 mg/kg/hr.~      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients~     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,~     24, 48 hours postoperatively.~   "
134687|NCT01291966|"~     The purpose of this study is to demonstrate that an intervention based on the motivational~     interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to~     reduce the errors of Medication in major measure that the habitual intervention.~   "
136480|NCT01268553|"~     The purpose of this study is to assess tolerability and clinical effects of transition from~     intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the~     recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial~     hypertension (PAH).~      Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients.~      The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for~     treatment of PAH many years ago. While these medications improve exercise capacity and the~     symptoms of PAH, they are given by injection and thus have several side effects, such as~     pain and catheter infection. This has resulted in many patients either refusing to take the~     medication or quitting these medications because of not tolerating them.~      The only other form of prostacyclin treatment available for PAH patients is inhaled. There~     are 2 inhaled prostacyclins approved for PAH, however one of these requires at least 6~     inhalations per day, every day, and takes about 30 minutes to inhale each time. Thus, it has~     not been a regularly-used medication and issues surrounding compliance make it a riskier~     drug to use if patients do not get their full doses every day. The other inhaled medication,~     treprostinil, was approved a few months ago, only needs to be given 4 times a day, and takes~     about 2-3 minutes to inhale.~      Since inhaled treprostinil can be administered easily, it is anticipated that many patients~     will transition from epoprostenol or treprostinil to the recently approved inhaled~     treprostinil, however we do not know if this is a safe or effective way to manage patients.~     Thus, the goal of this prospective study is to gather observational data regarding how that~     switch is made, tolerability of the switch, and, to the extent possible with this~     methodology, assess clinical effects of the switch.~      This is a prospective study. Twenty patients > 18 years old with PAH will be enrolled.~     Patients enrolled will be those in whom a clinical decision to convert from either IV~     epoprostenol, IV treprostinil, or SQ treprostinil to inhaled treprostinil therapy has been~     made. This is usually the result of patients asking to switch to inhaled therapy, but only~     allowed by physicians if they feel the switch would be safe.~      If eligible, and after informed consent, patients will have a history and physical~     examination, a 6 min walk test, a cardiopulmonary exercise test (CPET), blood tests, and a~     symptom questionnaire will be filled out. Patients will then be admitted to the hospital~     where a monitoring catheter will be placed inside the patient's heart and inhaled~     treprostinil will be initiated, while the dose of IV/SQ medication is reduced over about~     24-26 hours.~      Clinical follow-up will be at weeks 1, 4, and 12.~      The procedures above are all part of the routine clinical care that patients would receive~     if they were to be transitioned to inhaled therapy, including the hospitalization and~     catheterization. The criteria for them to be able to be switched are conservative. Pressure~     in their heart and lungs must be low (mPAP < 40 mmHg and RAP <12 mmHg on catheterization),~     and their dose of IV or SQ medication must be low (< 20 ng/kg/min). Regarding the patient~     subset enrolled in this study in whom a clinical decision to convert transition therapy has~     been made, we will try to ensure that our clinical decision-making will not be influenced by~     the need to enroll subjects in the study by explicitly noting the potential for conflict of~     interest with each patient (addressed in the ICF). We will not make a clinical decision for~     our patients based on the desire to fill the study numbers, and every will be made to avoid~     the potential for a perceived conflict of interest.~   "
134689|NCT01291940|"~     The goal of this study is to better understand what effect emollients (moisturizers) have on~     the skin in young children and adults.~      Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University~     (OHSU) research opportunities website.~        1. Adult and Adolescent Study:~           Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit,~          a baseline visit, and a final visit. Adults with a history of eczema will be asked to~          apply one of four possible moisturizers to one arm and nothing to the other arm for~          four weeks. The moisturizers, which will be assigned to the subjects, include either~          Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or~          Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for~          their skin condition, but may not treat the arms during the study. Non-invasive tests~          of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin~          measurements that will be performed are:~             -  Transepidermal loss (TEWL)- measures how much water is lost across the skin~               barrier~             -  Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure~               skin barrier function after tape-stripping~             -  Skin electrical capacitance - measures the moisture in the top layer of skin~             -  Skin pH - measures the acidity of the skin~             -  Stratum corneum cohesion assay - tape-stripping to measure the protein removed~               from the top layer of skin~             -  Lipidomic analysis - measures the lipids, or oils, in the top layer of skin~               Control - There will be 1-2 visits for this group: a screening visit and baseline~               visit, which can be combined. Non-invasive tests of the skin will be taken and~               include the skin measurements that will be performed are the same as the~               Moisturizer Intervention group.~        2. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline~          visit, and a final visit. Infants and toddlers between 3 months and 3 years of age~          without a history of skin barrier diseases will be assigned to a moisturizer, which~          include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe~          Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of~          the skin will be made at Visit 1 and after four weeks (Visit 2).~             -  TEWL- measures how much water is lost across the skin barrier~             -  Skin electrical capacitance - measures the moisture in the top layer of skin~             -  Skin pH - measures the acidity of the skin~   "
134690|NCT01291927|"~     The purpose of this study is to investigate the feasibility, safety, and long-term prognosis~     of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of~     early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis~   "
134691|NCT01291914|"~     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005~     for the treatment of pain in patients with osteoarthritis of the knee.~   "
134692|NCT01291901|"~     The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain~     scores and pain medication usage in subjects with intractable pain due to malignant disease.~     A second purpose is to confirm safety and secondary efficacy measurements.~   "
134693|NCT01291888|"~     The investigators postulate that nebivolol will be more effective than an equivalent dose of~     a comparative BB, specifically sustained release metoprolol succinate, in improving the~     availability of NO, lowering blood pressure, and reducing albuminuria with implications for~     slowing progression of CKD and cardiovascular protection in this high risk population.~      The objective of this proposal is to conduct a randomized pilot clinical trial to determine~     the relative efficacy and tolerability of nebivolol versus sustained release metoprolol~     succinate in improving blood pressure in patients with CKD and albuminuria. The primary~     endpoint would be a decrease in asymmetric dimethyl arginine (ADMA). Secondary endpoints~     would include a reduction in blood pressure, urinary F2-isoprostanes and albuminuria.~   "
134694|NCT01291875|"~     The studies that correlate periodontal disease (PD) and diabetes mellitus (DM) suggest that~     individuals with poor glycemic control are at increased risk for developing infections.~     Despite being controlled for other important risk factors, diabetic patients are three times~     more likely to develop PD, and therefore, periodontitis has been proposed as the sixth~     complication of DM.~      Besides the effect of diabetes on DP, the reverse has also been studied over the past 15~     years, through the idea that chronic and acute infections can directly affect the tissue~     resistance to insulin. Recent studies have provided evidence that controlling periodontal~     infection has an impact on improvement of glycemic control in diabetes mellitus patients.~     The vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory~     mediators, pathogenic bacteria and their products into the bloodstream. Some researchers~     have suggested that periodontal treatment in type 2 diabetes mellitus (DMT2) patients,~     results in beneficial effect on the level of glycemic control. However, there is no~     conclusive evidence to support this hypothesis.~      This research project aims to determinate the impact of periodontal therapy on metabolic~     control in DMT2 individuals, and determinate the possible association between periodontal~     disease and DMT2. For the HbA1c outcome this clinical trial had a sample size calculation~     estimated at 120 patients. For the inflammatory serum markers this study had a sample size~     estimated at 22 individuals. Blood samples will be collected for evaluation of Hba1c and~     inflammatory serum markers. This data will highlight the possible role of periodontal~     therapy on DMT2 metabolic control.~   "
134695|NCT01291862|"~     Obstructive sleep apnea is a common disorder linked to serious long-term adverse health~     consequences; such as hypertension, metabolic dysfunction, cardiovascular disease. Retinal~     vascular occlusion is related to many systemic illnesses especially hypertension.~     Obstructive sleep apnea is also related to vascular endothelial dysfunction and vascular~     endothelial growth factor elevation which causes vision threatening complications of retinal~     vascular occlusion. Therefore the relationship between obstructive sleep apnea and retinal~     vascular occlusion should be studied.~   "
134696|NCT01291849|"~     After nasal surgery, emergence cough or straining will produce venous engorgement and~     increase bleeding from the surgical site, so the necessity for smooth extubation without~     severe cough during emergence provides a challenge for the anesthetists. Recently,~     remifentanil is commonly used short-acting opioid, and several studies have demonstrated the~     antitussive effect of remifentanil via effect-site target-controlled infusion during~     emergence. However, there may be gender difference in response to opioid, and the previous~     studies about antitussive effect of remifentanil are targeted at female patients and there~     is no investigation of effect site concentration of remifentanil for male patients~     undergoing nasal surgery. The purpose of this study is to evaluate the effect-site~     concentration of remifentanil via target-controlled infusion for preventing cough in man~     after sevofluorane balanced anesthesia.~   "
134697|NCT01291836|"~     AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in~     predicting worsening kidney function in patients who present with acute heart failure (AHF)~     and who are treated with diuretics. It is believed that rising NGAL levels in the blood~     and/or urine can predict acute kidney injury. It is also believed that patients who are~     admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.~   "
134698|NCT01291823|"~     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over~     30 fractions, and concurrent with Gefitinib.~   "
134700|NCT01291797|"~     This study aims to examine performance on a neurological screening test, the Dubowitz, and~     sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with~     congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It~     will compare the results of these studies to neonates without CHD.~   "
134701|NCT01291784|"~     TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with~     myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and~     myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The~     investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the~     fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation.~     This is a novel approach to the treatment of patients with myelofibrosis.~   "
134702|NCT01291771|"~     Cardiovascular diseases are the leading cause of mortality in patients with end stage renal~     disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non~     invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the~     incidence of significant coronary stenosis (>70%) is low. The goal of this observational~     study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular~     disease in patients with end stage renal disease scheduled or not for kidney~     transplantation. These patients routinely undergo non invasive detection of myocardial~     ischemia. Patient included in the study will be followed up for 2 years for major~     cardiovascular events. Patients with detected myocardial ischemia during non invasive~     testing are being explored by coronary angiography. During coronary angiography additional~     detection of myocardial microvascular disease is being performed by simultaneous measurement~     of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of~     the index of microcirculatory resistance (IMR).~      Comparison of cardiovascular outcomes between patients with and without myocardial ischemia~     and patients with and without myocardial microvascular disease will be performed.~   "
134703|NCT01291758|"~     The purpose of this study is to determine if submaximal exercise by bicycle stress tests~     with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days~     causes a higher level of exertional exhaustion in GWI compared to healthy veterans~     (HVets).~   "
134704|NCT01291745|"~     The present study is designed to determine the mutational status of markers (TET2 and PLCb2,~     cytogenetic aberrations) together with methylation status of the above genes using bone~     marrow and matched buccal cell samples from MDS patients who necessitate to start a~     treatment (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be~     followed for at least 2 years.~   "
134705|NCT01291732|"~     The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics in Asian healthy males administered a single dose of BI 135585.~   "
134706|NCT01291719|"~     The purpose of this study is to study the use of a counterbalancing system of glucose and~     insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can~     produce tight glycemic control without hypoglycemia; study to develop a closed loop for use~     in intensive care units and surgery~   "
134707|NCT01291706|"~     Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary~     neurological deterioration. Their outcome within the first week after injury could be~     predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to~     the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to~     screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e.,~     Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative~     predictive value of TCD.~   "
134708|NCT01291693|"~     The aim of this study is to investigate whether motivation-tailored alcohol interventions~     are more effective when delivered by person or by computer-generated feedback letters. A~     sample of 920 general hospital inpatients with risky drinking will be recruited through a~     computerized screening procedure. Patients with more severe alcohol problems will be~     excluded from the study. Participants will be allocated by time frame randomization to one~     of three study arms: (1) personal counseling based on Motivational Interviewing, (2)~     computer-expert system intervention that generates individualized feedback-letters, and (3)~     control group (treatment-as-usual). The interventions differ in their channel of delivery,~     but not regarding their content. Both intervention groups receive interventions at three~     time points: directly after the baseline-assessment at the general hospital, and 1 and 3~     months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24~     months after baseline.~   "
134709|NCT01291680|"~     Chronic pain is common. Up to 10% of the Population has been estimated to suffer from~     chronic pain and up to 5% of the female population has been estimated to suffer from~     widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology~     (ACR) criteria for classification of fibromyalgia syndrome (FMS). FMS is characterized by~     the presence of both allodynia and hyperalgesia. FMS is also characterized by disturbances~     of the autonomic nervous system such as orthostatic intolerance, postural tachycardia etc.~     The effect of these conditions during gestation and post partum periods is not well known.~      Parturition is a complex process which involves multiple endocrine and physiological changes~     within a short period of time. Severe pain is an important attribute of this natural~     process. The purpose of the current study is to evaluate the impact of chronic central pain~     on the process of parturition. Our hypothesis is, that women demonstrating signs, symptoms~     and a history of central pain, before the onset of active labor, will differ from women not~     demonstrating such traits; these women may require earlier higher does of analgesia, and may~     demonstrate increased hemodynamic lability during labor and delivery.~   "
134710|NCT01291667|"~     Breast cancer is the most common malignant disease and the most frequent causes of cancer~     mortality in females worldwide. The situation is same as the world in China. Trastuzumab has~     been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is~     developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III~     trial in order to prove Cipterbin® 's efficacy and safety.~   "
134711|NCT01291654|"~     The investigators propose that paracetamol will be similarly effective to ibuprofen in~     treating PDA in the premature neonate, with fewer side effects.~   "
134712|NCT01291641|"~     The purpose of this study is to evaluate the additional effect of probucol or concomitant~     administration of cilostazol and probucol on mean carotid artery intima-media thickness~     (mean IMT) at year 1, 2, and 3.~   "
134761|NCT01291004|"~     This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared~     to two 28-day oral contraceptive regimens containing different synthetic progestins on~     ovarian follicular activity and hormone levels in healthy women.~   "
134762|NCT01290991|"~     Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects~     of the knee?~   "
134713|NCT01291628|"~     Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome~     called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness~     and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side~     effect. There is no way to prevent or an effective way to treat this side effect. The~     investigators aim is to investigate whether wearing socks which contain copper fibers may~     prevent or alleviate the patient symptoms.~   "
134714|NCT01291615|"~     To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant~     therapy after hemihepatectomy~   "
134715|NCT01291602|"~     This is a single and multiple dose study in healthy male and female (of non-childbearing~     potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug~     levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.~   "
134716|NCT01291589|"~     The purpose of this study is to pilot test an innovative program development project in an~     open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention~     on ten (10) HIV-infected men who have sex with men who report very high levels (>10~     episodes) of sexual transmission risk behavior (unprotected anal intercourse with~     serodiscordant partners).~   "
134717|NCT01291576|"~     The purpose of this study is to determine whether performing colorectal resection in deep~     endometriosis infiltrating the rectum is responsible for a higher rate of postoperative~     digestive and urinary dysfunction when compared to rectal nodules excision (conservation of~     the rectum).~   "
134718|NCT01291563|"~     The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on~     the QT/QTc interval in healthy volunteers.~   "
134719|NCT01291550|"~     The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical~     symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The~     purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify~     neurodegenerative conditions and ADHD based on breath testing.~      Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal~     conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative~     power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six~     nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to~     the NA-NOSE signals in order to detect statistically significant differences between the~     sub-populations, and classification success will be estimated using leave-one-out~     cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the~     chemical composition of the breath using gas-chromatography in conjunction with~     mass-spectrometry (GC-MS).~   "
134720|NCT01291537|"~     The goal of this multicentric prospective randomized controlled clinical and economic study~     is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal~     infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe~     form of Parkinson's disease.~   "
134721|NCT01291524|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately~     following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750~     calorie evening meal as compared to a single dose of the pregabalin immediate release~     (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin~     controlled release tablet administered with various caloric sized dinners and at bedtime as~     compared to a single dose of the pregabalin immediate release capsule.~   "
134722|NCT01291511|"~     The purpose of this study is to determine whether Iloperidone is effective in the prevention~     of relapse in patients with schizophrenia~   "
134723|NCT01291498|"~     This study aims to determine whether HIFU treatment is a safe and effective alternative to~     an operation to remove all or part of the affected gland. The objective is to achieve~     biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and~     one year after therapy) without affecting the patient's voice or ability to swallow.~   "
134724|NCT01291485|"~     The purpose of this study is to develop and examine the feasibility and initial efficacy of~     a computer-based intervention to improve medication adherence among people living with HIV.~   "
134725|NCT01291472|"~     The purpose of this study is:~        -  to document ketorolac disposition (concentration/time profile, protein binding,~          metabolism) and its covariates following intravenous (iv) administration of ketorolac~          right after caesarean section and to compare those observations (n=32) with~          non-pregnant state (n=8) (intra-subject PK comparison)~        -  to document biochemical tolerance of ketorolac~        -  to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are~          appropriated and needed~        -  to quantify the neonatal exposure to ketorolac through excretion in the breast milk~   "
134726|NCT01291459|"~     Background and Rationale~      Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have~     demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared~     well tolerated with low metabolic toxicity. No data are currently available concerning the~     combination of these 2 drugs.~      Hypothesis~      Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive~     patients infected by CCR5 HIV-1 previously treated for 6 months with a~     Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.~   "
134727|NCT01291446|"~     Background Some patients complain of excessive evacuation, which may become socially~     disabling (Azpiroz F & Malagelada J-R, 2005). However, there no systematic investigation on~     the range of gas evacuation in healthy subjects and in subjects complaining of flatulence~     under basal conditions and in response to a high-flatulogenic diet (Azpiroz F & Levitt DG,~     2009).~      Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal~     gas production and more anal gas evacuation during basal conditions and in response to a~     high flatulogenic diet than healthy subjects. This abnormality is related to the differences~     in colonic microflora.~      Objectives~        -  To determine the normal range of intestinal gas evacuation under basal conditions and~          in response to a high flatulogenic diet.~        -  In patients complaining of flatulence, to determine whether intestinal gas evacuation~          under basal conditions and in response to a high flatulogenic diet is increased.~        -  To identify differences in the microbiota pattern in subjects with normal and excessive~          anal gas evacuation.~        -  In patients complaining of flatulence, to determine the segmental distribution of~          intestinal gas after a diet challenge.~      Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a~     3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic~     diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g~     measurements will be performed: daily measurement of the number of anal gas passages with an~     event marker, continuous recording of anal gas evacuation in the laboratory using an~     electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and~     segmental gas distribution in the gut by abdominal computer tomography (CT) imaging.~      Relevance These studies will allow to develop the normal range of anal gas evacuation during~     basal conditions. Furthermore, a provocative test will be developed for the diagnosis of~     excessive gas production in patients complaining of flatulence. This data will allow a~     proper diagnosis of these patients and will pave the path for a rational management and for~     the development of evidence-based treatment strategies. This pilot study will allow a proper~     design with adequate sample size calculation in future interventional studies.~   "
134728|NCT01291433|"~     Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve~     complication of radiotherapy, that is spontaneously irreversible with no medical treatment~     to limit or reduce symptoms. The investigators planed in RIP a randomized double blind~     clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus~     placebo, to assess a possible symptomatic regression by a sensory-motor neurological~     quantifiable and reproducible score (modified Subjective Objective Medical management~     Analytic, SOMA).~      The investigators previously developed a successful PE treatment in symptomatic RI injuries~     via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a~     major significant radiation-induced fibrosis regression, then the PE clodronate combination~     (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and~     significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50~     partial RIP.~      The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its~     tolerance in long survival patients irradiated before for cancer and presenting with partial~     RIP of upper or lower legs.~      The investigators calculated to include 60 patients to show a significant clinical~     difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400~     (2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple~     placebo, with prednisone 20 (2d/7) for all patients.~      RIP is assessed before treatment and every 6 months by a standardized sensory-motor~     neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and~     various neurological scales of assessment (Visual Analog Scale for pain / VAS for~     paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],~     muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient~     Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and~     electrophysiology.~   "
134729|NCT01291420|"~     The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal~     vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the~     WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers,~     glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the~     results of our previously performed phase I study with autologous WT1 mRNA-transfected DC,~     the investigators hypothesize that the vaccination with DC will be well-tolerated and will~     result in an increase in WT1-specific CD8+ T cell responses.~   "
134730|NCT01291407|"~     The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting~     toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined~     with radiation therapy for locally advanced or recurrent gastric cancer.~   "
134731|NCT01291394|"~     This is a National, Multicentre, Observational Registry to study adherence and long term~     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment from hospitals in France and to assess the level of adherence of~     subjects receiving SAIZEN® via Easypod™.~   "
134732|NCT01291381|"~     While allergen specific immunotherapy (SIT) is highly effective for allergic diseases in~     children, the underlying immunological mechanisms are unclear. Regulatory T (Treg) cells may~     be crucial in induction of tolerance.~      Our aim was to investigate the role of CD4+CD25+Foxp3+ T cells and IL-10-secreting type I T~     regulatory (Tr1) cells in the response to one year of cluster SIT to Dermatophagoides~     pteronyssinus for allergic rhinitis in children.~      CD4+CD25+Foxp3+regulatory T cells and IL-10-secreting type I T regulatory (Tr1) cells were~     analyzed in children allergic to Dermatophagoides pteronyssinus during one year cluster~     specific immunotherapy (SIT) in a prospective and randomized study. Peripheral blood~     mononuclear cells (PBMCs) were collected from 25 children receiving SIT and 21 receiving~     pharmacotherapy. The frequencies of CD4+CD25+Foxp3+ T cells and allergen-specific~     IL-10+IL-4-, IFN-γ+IL-4-, IL-4+IFN-γ-CD4+ T cells were measured by flow cytometry.~     Production of IL-4, IFN-r, and IL-10 in supernatants from allergen-stimulated PBMC culture~     was measured by ELISA. Finally, the suppressive effect of CD4+CD25highTreg cells from both~     groups was estimated.~   "
134733|NCT01291368|"~     The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients~     influences the development of delirium during their ICU stay and if incidences of delirium~     have an impact on the development of Post-traumatic Stress-Disorder (PTSD).~      Hypothesis 1:~      Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes~     of delirium than patients that are heavily sedated~      Hypothesis 2:~      Former delirious patients are more likely to develop PTSD~      Hypothesis 3:~      Delirium decreases health-related quality (HRQoL) of life after discharge~   "
134734|NCT01291355|"~     The aim of the study is to evaluate the efficacy of a specific maternal position to correct~     fetal position in occipito-posterior during the labor.~      The investigators hypothesize that the maternal position described by the Dr de Gasquet~     facilitate the rotation in occipito-anterior during the labor.~      The calculated sample size is 438 participants (219 in each group)~   "
134735|NCT01291342|"~     Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of~     the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of~     preeclampsia is unknown.~      Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to~     derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most~     likely to be involved.~      More than 100 clinical, biophysical, and biochemical tests have been recommended to predict~     or identify the patient at risk for the future development of the disease.~      The results of the pooled data for the various tests and the lack of agreement between~     serial tests suggest that none of these clinical tests is sufficiently reliable for use as a~     screening test in clinical practice. As a result there is obviously a great need to develop~     a novel technology for the early detection of this pregnancy complication before its~     clinical manifestations appear. An early detection can help in early treatment to prevent or~     at least minimize the sequel of this disease.~      The aim of this project is the early detection of Preeclampsia and other pregnancy~     complications using volatile biomarkers appearing in exhaled breath and/or blood samples,~     using a simple and inexpensive toll termed NA-NOSE.~      Phase-I: The primary phase of this project is the comparison between volatile biomarkers'~     patterns of pregnant women suffering from Preeclampsia, pregnant women that are considered~     to have Normal Pregnancy, and healthy Non-Pregnant women.~      Phase-II: The secondary phase of this project is the ability to predict Preeclampsia, as~     compared, head-to-head, with other potential predictors used in the current clinical~     practice.~   "
134736|NCT01291329|"~     The purpose of this study is to investigate the safety and efficacy of intracoronary human~     umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with~     ST-segment elevation acute myocardial infarction.~   "
134763|NCT01290978|"~     The purpose of this study is to find out if presurgical antiseptic preparations affect how~     well surgical drapes adhere to skin.~   "
134764|NCT01290965|"~     This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing~     hepatitis C virus (HCV) RNA levels.~   "
134737|NCT01291316|"~     In animal, the GABAergic system modulates central sensitisation, which is a key phenomenon~     in pain processing. The development of GABAA agonists targeting the subunits of the GABAA~     receptor implicated in nociception, but not the subunit implicated in sedation is attractive~     as it opens new perspectives of testing the role of GABAergic modulation of pain processing~     in human volunteers. The purpose of this subproject is to test the effect of the specific α2~     and α3 agonist but sparing α1 effect TPA023 on a human model of peripheral and central~     sensitisation and to correlate its pharmacodynamic effect with the pharmacokinetic of the~     compound.~      The results would contribute to clarify the potential role of these α2/α3 agonist but~     sparing α1drugs in clinical pain conditions.~   "
134738|NCT01291303|"~     The analysis of flow and pressure curves generated by ventilators can be useful in the~     individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however,~     a real clinical benefit of this approach to optimize ventilator setting has not been proven.~     The aim of the present study was to compare: optimized ventilation, driven by the analysis~     of flow and pressure curves, and standard setting (same initial setting, same time at the~     bedside, same physician, while the ventilator screen was obscured with numerical data always~     available). The primary aim was the normalization of pH at two hours, whilst secondary aims~     were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter~     evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of~     ventilation). 70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05,~     mean±SD) have been enrolled, with no basal difference between the two groups.~   "
134739|NCT01291290|"~     The purpose of this study is to investigate the effect of platelet infusion prior to~     transfer to a vascular surgical department in patients with a ruptured abdominal aortic~     aneurism.~   "
134740|NCT01291277|"~     Patients with liver disease frequently present to the hospital with bleeding from dilated~     veins in their foodpipe (called esophageal varices). The current standard of care is to~     perform endoscopic variceal ligation (placing rubber bands around the varices through an~     endoscope)in patients presenting with bleeding varices. Patients generally receive ligation~     at the time they come in with bleeding and then return at regular intervals to have repeat~     ligation in order to eradicate the varices. However there have been no studies to determine~     the appropriate intervals for esophageal variceal ligation until eradication. We will~     conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in~     patients that have presented with bleeding varices. Our hypothesis is that one-week ligation~     will achieve more rapid eradication than the two-week interval with a greater proportion of~     patients achieving variceal eradication at 4 weeks after the index bleeding episode.~   "
134741|NCT01291264|"~     Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San~     Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California,~     San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain~     reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two~     sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG],~     using urine samples and swabs from the throat and rectum of men who have sex with men [MSM].~     Using this test on these swabs is experimental because it has not been approved by the Food~     & Drug Administration.~   "
134742|NCT01291251|"~     The guidelines of The Norwegian authorities concerning the use of antibiotics in general~     practice state that for several common diseases such as pneumonia and tonsillitis,~     antibiotics should be given four times daily instead of three times daily. The study´s aim~     is to see whether the patient compliance is significantly reduced in antibiotic regimes of 3~     or 4 daily doses as compared to 1 or 2 daily doses.~   "
134743|NCT01291238|"~     A whole of school intervention with daily physical activity and healthy food for students~     with intellectual disabilities. The aim is to provide plenty of concrete examples of healthy~     life style choices and using school personnel and peers as role models. This will presumably~     result in healthier weight, better fitness and not least in new familiar healthy habits.~   "
134744|NCT01291225|"~     Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop~     playgrounds in Chillicothe.~      Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play~     areas for children on farms.~   "
134745|NCT01291212|"~     The investigators have previously demonstrated the utility of transdermal testosterone in in~     vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate~     the efficacy of luteinizing hormone (LH) activity added to recombinant follicular~     stimulating hormone (FSHr) during ovarian stimulation in these patients.~   "
134746|NCT01291199|"~     The purpose of this study is to determine whether vardenafil is effective in improving~     clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud~     phenomenon.~   "
134747|NCT01291186|"~     The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal~     anesthesia has not been well established. The investigators tried to quantify the effect of~     BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine~     between two different BMI groups.~   "
134748|NCT01291173|"~     To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to~     severe binge eating disorder as measured by the number of binge days per week~   "
134749|NCT01291160|"~     This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12~     weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of~     Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the~     effectiveness of EPIFLO in combination with standard wound therapy on wound healing as~     compared to standard wound therapy alone; and 2) Screening for potential safety issues.~      Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be~     enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen~     consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive~     debridement. Subjects will be randomized to either the Treatment arm or the Control arm.~     Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment~     Period, once two weeks after wound closure and once at the end of 12-week durability Period.~   "
134938|NCT01288690|"~     This interventional, randomized controlled study tests the effects of a a brief~     psychological intervention (Narrative Exposure Therapy) against a wait list control group~     among refugees who have experienced trauma and have some symptoms of PTSD.~   "
134750|NCT01291147|"~     More hysterectomies are performed laparoscopically either as a total laparoscopic~     hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of~     laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost~     effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and~     vaginally assisted) can lead to discomfort which may lead to a delay in discharge from~     hospital. Continuous infusions of local anaesthetic agents given post operatively to the~     site of operation have the been subject of trials for several operative procedures. To date~     however there have not been any properly controlled studies evaluating whether there are~     benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a~     total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose~     to investigate whether giving a local anaesthetic infusion in this fashion decreases the~     amount of rescue and patient controlled analgesia needed, and length of hospital stay. In~     order to do this the investigators wish to conduct a randomised placebo controlled double~     blind trial.~   "
134751|NCT01291134|"~     The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing~     PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).~   "
134752|NCT01291121|"~     The main objective is to determine the efficacy of intravitreal administration of~     Ranibizumab combined with intravitreous injection of expansile gas and induction of~     posterior vitreous detachment on best-corrected visual acuity and ocular coherence~     tomography (OCT) macular thickness in subjects with neovascular age-related macular~     degeneration (AMD) with posterior vitreomacular adhesion (VMA).~      Secondary objectives are to assess the safety and tolerability of the intravitreal~     administration of Ranibizumab combined with intravitreous injection of expansile gas.~   "
134753|NCT01291108|"~     This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared~     with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in~     patients with primary open-angle glaucoma or ocular hypertension.~   "
134754|NCT01291095|"~     The aim of this trial is to compare the accelerated fractionation radiotherapy and~     concurrent chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma~     patients in terms of loco-regional control, toxicities and quality of life.~   "
134755|NCT01291082|"~     Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted~     imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone~     metastases.~   "
134756|NCT01291069|"~     This pilot study is aimed at assessing the short-term effects of Tadalafil on the~     hemodynamic response to exercise and exercise capacity in patients with Fontan circulation.~     Data regarding effect size and drug tolerability will be used in the design of a randomized~     multicenter trial. The long-term goal of this investigation is to systematically evaluate~     the effect of tadalafil therapy on exercise performance, quality of life, and delay of~     functional deterioration in patients with single ventricle physiology.~   "
134757|NCT01291056|"~     Clomiphene citrate is commonly used for ovulation induction in women with anovulation,~     correction of luteal phase deficiency or for superovulation as empiric therapy for~     unexplained infertility. Superovulation using clomiphene, usually with intrauterine~     insemination, is usually regarded as first line therapy for unexplained infertility,~     infertility due to mild endometriosis, or infertility with mild or moderate compromise of~     the male factor. The side effect profile reported by some women using clomiphene citrate is~     similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension,~     irritability, depressed mood, affective lability, lack of energy, difficulty concentrating,~     and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain.~     Few studies have been performed to examine the relationship between clomiphene citrate and~     mood symptoms; however, these studies have been limited by their small sample size,~     potential for recall bias and lack of randomization. Moreover, the experience of infertility~     is dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the~     cycle, and how often clomiphene is associated with mood changes is needed. Such a study~     would add to the body of literature on this topic in three important ways: 1) use of~     prospective data collection to more accurately identify commonly reported symptoms, 2)~     characterize the timing of symptom occurrence relative to treatment cycle, and 3) provide~     information relevant to planning of future studies involving targeted treatment of~     clomiphene citrate induced symptoms. If clomiphene use is shown to affect mood, the results~     would point to an important avenue for psychopharmacologic insight into relationships~     between mood and sex steroids.~      OBJECTIVES:~      Specific Aim #1: To identify psychological and physical symptoms experienced by women taking~     clomiphene citrate for superovulation in a prospective, placebo controlled trial setting.~      Specific Aim #2: To determine whether measures of the emotional and physical state prior to~     the administration of clomiphene, predict the occurrence of mood changes during the five~     days of clomiphene administration and in the late follicular and luteal phases of the cycle~     in which clomiphene was administered.~   "
134758|NCT01291043|"~     Fibromyalgia is a syndrome characterized by chronic and generalized musculoskeletal pain and~     tenderness in tender points. Its etiology and physiopathology are not well known; therefore~     its treatment is not satisfactory. Having this in view, a search for alternative and~     complementary medicine has been going on. This kind of practice is under pressure to present~     evidences of efficacy. A randomized clinical trial will be carried out with the aim of~     verifying the efficacy of a massage technique called Shiatsu in the improvement of pain,~     flexibility, quality of sleep, anxiety and quality of life of individuals with fibromyalgia.~     A sample of 34 subjects will be divided in Shiatsu Group and Control Group. All subjects~     will be evaluated in the beginning, in the middle and at the end of the treatment. Pain will~     be evaluated by the following instruments: visual analogue scale (VAS) and dolorimetry. The~     V-sit and reach test (VSRT) will be used to assess the flexibility of the hamstring muscles~     and lower back. The sleep will be evaluated with the Pittsburgh Sleep Quality Index (PSQI).~     The State-Trait Anxiety Inventory (STAI) will be used to evaluate anxiety. The evaluation of~     quality of life will be made with two instruments: fibromyalgia impact questionnaire (FIQ)~     and Activities-specific Balance Confidence (ABC) scale. In each treatment session, the~     subjects will be globally evaluated in the 14 main meridians and their respective points by~     touch, identifying points of excessive energy and their severity. The Control Group will~     wait for treatment and remain only with conventional pharmacological treatment, while the~     Shiatsu Group will receive a treatment with Shiatsu during eight weeks. The results will be~     expressed in mean and standard deviation. The normality of the data will be verified by the~     Shapiro-Wilk test. In the intragroup analysis, the T-test for the parametric data and the~     Wilcoxon test for the nonparametric data. In the comparison between groups, the analysis of~     variance (ANOVA) test will be used. The level of significance adopted will be α < 0.05.~   "
134759|NCT01291030|"~     Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced~     renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose~     metabolism disorders, including insulin resistance and decreased insulin secretion, are also~     prevalent post-transplantation and often precede the development of diabetes. As magnesium~     supplementation has been demonstrated to increase insulin sensitivity in both diabetic and~     non-diabetic patients, its potential therapeutic supplementation (post-transplantation)~     deserves further examination. The hypothesis is that magnesium supplementation in renal~     transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.~   "
134760|NCT01291017|"~     The purpose of this study is to determine the efficacy and the toxicities of the study drug~     PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with~     wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in~     the tumor.~   "
134766|NCT01290939|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such~     as lomustine, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. It is not yet known which regimen of~     bevacizumab given together with lomustine is most effective in treating patients with~     glioblastoma multiforme in first recurrence.~      PURPOSE: The primary objective of this study is to investigate whether the addition of~     bevacizumab to lomustine improves overall survival (OS) in patients with recurrent~     glioblastoma compared to treatment with lomustine alone.~   "
134767|NCT01290926|"~     Prospective non-randomized phase II study assessing the activity of the~     Capecitabine-Sorafenib combination by estimating overall survival of the study population at~     a fixed time point (6 months) and, as an exploratory analysis the overall survival of~     metabolic responders versus non-responders.~   "
134768|NCT01290913|"~     This is a pilot feasibility study, using Xolair pretreatment for oral peanut~     desensitization.~   "
134769|NCT01290900|"~     This is a single dose study in healthy male volunteers to investigate the effect of high~     doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT~     interval~   "
134770|NCT01290887|"~     The primary objective of the study is to evaluate the long-term safety of reslizumab at a~     dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult~     patients with eosinophilic asthma as assessed by adverse events, physical examination~     findings, vital sign measurements, and concomitant medication usage throughout the study~     (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.~   "
134771|NCT01290874|"~     We are doing this study to learn how genes affect the way that people, specifically Black~     people, respond to treatment for asthma. Recent studies suggest that people respond~     differently to some asthma medications (eg Serevent, Foradil). Some people feel better when~     they use these inhalers, but others may not, and some people get worse. It seems that this~     difference shows up more often in Blacks than in Whites, which is why we are looking for~     Black subjects for this study. In all people, this difference seems to depend on their genes~     or DNA. This study is comparing the use of long acting asthma medications (Serevent,~     Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat~     chronic obstructive pulmonary disease (COPD). This study will help to see if this medication~     is also useful for treating asthma and whether it works better for some people than the~     current asthma medications.~   "
134772|NCT01290861|"~     The overall objective of this study is to identify a 60 minute cognitive battery, for~     subsequent use in clinical trials, that detects cognitive deficits in early HD and late~     pre-manifest HD compared to controls, and that has a potential to show drug induced~     improvements.~   "
134773|NCT01290848|"~     This project will evaluate the effectiveness of the Take TIME health promotion campaign. The~     Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target~     parents and caregivers of children up to 8 years of age.~      The study will help answer the following research questions~        1. Are community organizations able and willing to deliver a health-promotion campaign~          targeting young children?~        2. What impact does the Take TIME campaign have on the readiness of the community to~          support healthy childhoods?~        3. What impact does the Take TIME campaign have on awareness and achievement of healthier~          lifestyles for young children?~        4. Can health promotion initiatives be institutionalized within the Municipality and~          community organizations so that the campaign will continue beyond the study period?~        5. Are changes in awareness and/or behaviour related to exposure to the Take TIME~          campaign?~   "
134774|NCT01290835|"~     The purpose of this study is to determine if it is feasible, safe, and effective to use~     Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients~     meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be~     delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total~     of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control~     and site of failure (if any).~   "
134775|NCT01290822|"~     This study tests optimization of biventricular pacing (BiVP) in patients with dilated~     cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in~     patients with advanced cardiac failure. It examines the effects of atrioventricular delay~     (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on~     cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an~     identical heart rate.~   "
134776|NCT01290809|"~     Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of~     the lung cancer population. The prognosis of these patients has improved over the years due~     the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The~     brain, however, remains one of the major sites of failure. Patients with brain metastasis~     suffer from a variety of neurological, cognitive and emotional difficulties that are known~     to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation~     (PCI) can prevent or delay the development of brain metastasis, and as such can improve~     neurological disease-free survival and consequently health-related quality of life. But~     survival is short, and toxicities are real, as PCI in itself can also induce adverse~     effects. The cognitive adverse effects of PCI are not sufficiently illuminated and~     documented, due to the lack of formal and systematic evaluation in patient populations~     expected to have short survival. Also, recent attempts to reduce cognitive side effects of~     PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have~     not been fully evaluated yet.~      Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs~     and benefits of this therapy should be investigated properly, to allow for well-informed~     treatment choices.~   "
134777|NCT01290796|"~     The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable~     Single-Incision Sling in the surgical treatment of female stress urinary incontinence.~   "
134831|NCT01290094|"~     This single arm, open label study will assess the efficacy and safety of and compliance to~     treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with~     post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg~     intravenously every three months. Anticipated time on study treatment is 12 months with a~     follow-up of 12 months.~   "
134778|NCT01290783|"~     Trial design:~        -  Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with Hyaluronic~          acid-Irinotecan or HA-Irinotecan) regimen.~        -  Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.~        -  Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria,~          Poland, Serbia, Russia, Ukraine and the United Kingdom).~        -  Dosing regimen:~             -  Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1~               (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be~               reduced to 150 mg/m2).~             -  Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with~               irinotecan.~             -  5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days~               (total 2400 mg/m2 over 46-48 hours) continuous infusion.~             -  Repeat every 2 weeks for 8 months.~        -  Patient accrual over approximately 12-14 months.~        -  Monitoring to 18 months post-randomization.~        -  390 patients.~        -  Progression Free Survival (PFS) primary endpoint.~        -  Safety analysis on the initial 20 patients.~   "
134779|NCT01290770|"~     Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries.~     Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is~     influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is~     associated with an increase risk of cardiovascular complications.~      Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular~     disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein~     molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic~     factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two~     study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is~     a risk factor for recurrent coronary events in obese patient.~      Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway~     inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct~     inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .~      The aim of this study is to research reverse association between Lp(a) and TFPI activity in~     obese patient with chest pain like stable angina suggesting atherosclerotic heart disease~     and effect of aspirin.~   "
134780|NCT01290757|"~     The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of~     dabigatran etexilate made from two different drug product batches.~      The reference batch is dabigatran etexilate hard capsules 150 mg using the currently~     approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard~     capsules using a new capsule shell (Capsugel). The test batch is the drug product intended~     for future commercial use.~   "
134781|NCT01290744|"~     This study is a double-blind, randomized controlled trial examining the effect on ENL~     reactions of giving an additional year of clofazimine after completion of MDT in leprosy.~   "
134782|NCT01290731|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus~     (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in~     Japan.~   "
134783|NCT01290718|"~     This single arm. open-label study will assess the efficacy and safety of Herceptin~     (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or~     recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with~     Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14~     of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle~     followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
134784|NCT01290705|"~     With this study two different therapeutic exercise regimens will be compared in patients~     with anterior knee pain (patellofemoral pain syndrome, PFPS).~   "
134785|NCT01290692|"~     TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can~     produce immune cells, called 'killer' white blood cells that have the ability to kill large~     numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to~     generate large numbers of those 'killer' white blood cells and to deliver those cells into~     your body so that they can kill your cancer cells.~   "
134786|NCT01290679|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in participants who are infected with genotype 1 hepatitis C virus who have~     never received treatment before. Participants will also receive peginterferon alfa-2a or~     peginterferon alfa-2b and ribavirin as part of their treatment.~   "
134787|NCT01290666|"~     Primary outcome variable is healing at the final follow up visit.~   "
134788|NCT01290653|"~     This study investigates the effect of two different techniques (dry needling and~     Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point~     (MTP). Subjects with active or latent MTP in this location of the muscle will be identified~     and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain~     or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck~     disability and electromyography (EMG) activity of the upper trapezius will be registered~     before and after six sessions of treatment.~   "
134789|NCT01290640|"~     The objectives of this study are four-fold:~        1. To determine the three-dimensional, in vivo kinematics for subjects having either a~          fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis,~          comparing the in vivo kinematics to determine if one implant type leads to a benefit~          for the patient.~        2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar~          III Prosthesis under in vivo, weight-bearing conditions during multiple activities~          (gait, stair descent, deep knee bend and chair rise).~        3. To determine if there is a correlation between in vivo kinematic data obtained using~          fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine~          if variability occurs between these two TKA types.~        4. To determine if a clinical benefit is either visibly detected (video camera) or~          quantifiably determined (questionnaire) for either TKA type.~   "
134832|NCT01290081|"~     The purpose of this study was to determine the prevalence of latent tuberculosis infection~     among injecting drug users and to conduct randomized controlled trial to evaluate a case~     management intervention aimed at increasing TB screening and treatment entry among injecting~     drug users referred from a methadone drug treatment program in Estonia.~   "
134790|NCT01290627|"~     This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces)~     of participants having a normal knee or a total knee arthroplasty (TKA) using one or two~     different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating~     Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image~     matching technique that will convert a two-dimensional (2D) fluoroscopic image into a~     three-dimensional (3D) image. In conjunction with the fluoroscopic analysis,~     electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a~     complete analysis of the knee joints. These results will help the orthopaedic community~     better understand knee motion so they can improve testing on existing implants and develop~     future implants that will further enhance patients' lives.~   "
134791|NCT01290614|"~     The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality~     improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2)~     adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based~     quality improvement program for patients with CKD and assess potential mechanisms for the~     intervention's effect.~      Hypothesis: Implementing a CCM based quality improvement program including system level~     support in the form of collaborative care, a CKD registry, and provider education will 1)~     reduce systolic BP in patients with poorly controlled hypertension, 2) increase the~     percentage of patients appropriately monitored for metabolic complications, and 3) decrease~     the rate of catheter use in patients initiating dialysis.~   "
134792|NCT01290601|"~     This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3~     days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria~     infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax~     relapse (hypnozoite eradication). It will also further establish the safety and tolerability~     of these doses of tafenoquine.~   "
134793|NCT01290588|"~     The purpose of this study is to determine the effect of age and ethnic background on ocular~     aqueous humor dynamics and biometric parameters. Data of normal healthy children and adults~     will be used as controls for future study of juvenile glaucoma, and diabetes and potentially~     for any other condition that affects intraocular pressure in children.~   "
134794|NCT01290575|"~     BMS-820132 is an investigational new drug being developed by BMS for treating Type 2~     diabetes. The purpose of this study is to test the safety/tolerability (potential side~     effects) of multiple doses of the investigational new drug, as well as the amount of study~     drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.~   "
134795|NCT01290562|"~     Patients with new or recurrent spine metastases are currently treated with low doses of~     radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic~     body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely~     to the metastases to be treated are administered in a small number of sessions, thus~     reducing the radiation damage to the surrounding tissue and areas of the spine.~      The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to~     conventional radiation for patients with no prior radiation, prior radiation, and in the~     post-operative patient~   "
134796|NCT01290549|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administered~     as a single agent by IV infusion to patients with relapsed or refractory hematologic~     malignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.~   "
134797|NCT01290536|"~     This is a prospective pilot study designed to document safety and efficacy of liver-directed~     therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer~     metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).~   "
134798|NCT01290523|"~     This is a prospective pilot study that will document the clinical experience of 30 patients~     with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90~     glass microspheres (TheraSphere®).~   "
134799|NCT01290510|"~     The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2%~     hyaluronan) in the treatment of painful tendinopathy.~   "
134800|NCT01290497|"~     The main objective is the comparison of three different dosage regimens of hyaluronic acid~     in the treatment of osteoarthritis of the knee.~   "
134801|NCT01290484|"~     There is an unsatisfied medical need for a first-line treatment of lymphatic malformations~     with a good benefit/risk profile. Based on a patient experience in the institution, the~     investigators plan to verify whether or not the medication sildenafil has a beneficial~     effect on lymphatic malformations. The investigators plan to do this by treating patients~     with lymphatic malformations with the medication sildenafil for a 20 week period. This is an~     investigator initiated study funded by an Innovations in Patient Care grant and a SPARK~     grant.~   "
134802|NCT01290471|"~     This is a Phase 1, open label study to assess the safety and tolerability of U3 1565,~     determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety~     and tolerability.~   "
134803|NCT01290458|"~     Consumption of vitamin supplements is a common practice among athletes or people~     participating in health promoting exercise programs. The reason for this interest in vitamin~     supplements is primarily because of the observation that enhanced production of reactive~     oxygen and nitrogen species (RONS) influence fundamental biological processes, such as gene~     expression, signal transduction and enzyme activity. In a muscle and exercise physiology~     context, a low level of RONS is required for normal force production, whereas marked~     increases in RONS can cause contractile dysfunction, resulting in muscle weakness and~     fatigue. On the other hand RONS are involved in signaling pathways and serve to up-regulate~     the expression of a number of genes and can exert favorable effects such as training~     adaptations.~      The present study will employ a valid eccentric exercise model to examine the influence of~     combined vitamin C and E supplementation after acute and chronic eccentric exercise on~     muscle damage and performance, redox status, hemolysis and lipid and lipoprotein profile.~   "
134804|NCT01290445|"~     A prospective population-based cohort study to examine whether varenicline use during~     pregnancy is associated with an increased risk of major congenital malformations in infants~     above that associated with smoking during pregnancy.~   "
134805|NCT01290432|"~     Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a~     novel substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female~     patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.~   "
134806|NCT01290419|"~     A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study~     to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in~     healthy adults (18 to 49 years of age).~      Study Objectives:~      Primary:~        -  To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein~          particle vaccine formulations.~      Secondary:~        -  To assess and compare the immunogenicity (neutralizing antibody and total anti-F~          antibody) of the 6 RSV-F protein particle vaccine formulations~        -  To confirm the dose sparing and value added effects of the aluminum phosphate~          adjuvant~   "
134807|NCT01290406|"~     This is an open label and single arm study to investigate the safety and efficacy of BEZ235~     in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or~     after first-line antineoplastic treatment for advanced endometrial carcinoma.~   "
134808|NCT01290393|"~     This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and~     other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual~     period between 30 days before and 90 days after any dose of CERVARIX, when compared to a~     Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18~     months after the last CERVARIX or GARDASIL dose.~   "
134809|NCT01290380|"~     The purpose of this study is to evaluate the potential inhibitory effects of ASA404 on~     CYP1A2, CYP2C9, CYP3A4 and CYP2C19 mediated metabolism on the respective probe drugs~     caffeine, diclofenac, simvastatin, and omeprazole, respectively. This will be accomplished~     by the simultaneous administration of four substrates as part of a cocktail in order to~     characterize the potential for in-vivo drug-drug interactions. This cocktail approach has~     been proposed per FDA guidance as a screening tool for potential in-vivo drug-drug~     interactions Compared to the individual administration of specific probes in multiple~     studies, simultaneous administration of multiple in-vivo probes of drug-metabolizing enzymes~     offer several distinct advantages such as minimizing the confounding influence of~     inter-individual and intra-individual variability over time. Substrates for the CYP enzymes~     were chosen based on the FDA guidance recommendations taking into account that 1. The~     substrates are specific for the individual CYP enzymes, 2. There are no interactions among~     these substrates; and 3. The study will be conducted in a sufficient number of subjects.~   "
134810|NCT01290367|"~     The purpose of this study is to compare two doses of immunoselected, culture-expanded,~     nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control~     intradiscal injections in subjects with chronic low back pain due to moderate Degenerative~     Disc Disease (DDD) at one lumbar level from L1 to S1.~      All investigational subjects in this study will undergo injection of either 6 million (M) or~     18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus.~     All control subjects will undergo an intradiscal control injection with either saline or~     hyaluronic acid only~   "
134811|NCT01290354|"~     The purpose of this study is to find out how much lapatinib can enter both normal brains and~     brains in which tumours secondary to breast cancer have developed.~   "
134812|NCT01290341|"~     This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group~     Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in~     the treatment of tinea pedis.~   "
134813|NCT01290328|"~     The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on~     the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The~     investigators hypothesize that epoetin alfa will raise hemoglobin.~   "
134814|NCT01290315|"~     The purpose of this study is to compare safety and the oxidative stress potential of two~     doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal~     single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia~     (IDA) in female subjects.~   "
134815|NCT01290302|"~     The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and~     subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of~     subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.~   "
134816|NCT01290289|"~     To compare combined spinal epidural, epidural and IV pethidine analgesia and their effects~     on the mother, fetus, newborn and the course of labor.~   "
134817|NCT01290276|"~     The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK)~     profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in~     normal healthy volunteers. After this initial phase, the investigators will follow with the~     Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and~     tolerability interactions following simultaneous administration of these ondansetron~     formulations with a 10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal~     healthy volunteers.~   "
134818|NCT01290263|"~     Primary Objectives~      Cohort A ‐‐ monotherapy:~      To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as~     measured by 6‐month progression‐free survival (PFS6)~      Cohort B - combination therapy:~      Phase I To determine the maximum tolerated dose of AMG 386 in combination with bevacizumab~     given at 10mg/kg every 2 weeks in participants with recurrent glioblastoma.~      Phase II To determine the efficacy of AMG 386 plus bevacizumab in participants with~     recurrent glioblastoma (GBM) as measured by 6‐month progression‐free survival (PFS6).~      Secondary Objectives:~      To evaluate radiographic response in both cohort populations. To evaluate overall survival~     in both cohort populations. To assess time‐to‐progression in both cohort populations. To~     investigate the safety profile in both cohort populations.~      Exploratory Objectives:~      To evaluate expression of factors associated with tumor angiogenesis using a multiples~     cytokine assay among participants undergoing therapy with AMG 386 with response to therapy~     and development of resistance.~      This is an open‐label Phase I/II study of AMG 386 monotherapy and AMG 386 in combination~     with bevacizumab. Two cohorts will accrue and will be assessed sequentially. Each cohort~     will enroll participants with recurrent GBM. Cohort A will assess recurrent GBM participants~     who receive AMG 386 monotherapy at 30 g/kg every week. (Cohort A initially accrued at a dose~     of 15mg/kg, but this was increased to 30 mg/kg every week following an amendment). Cohort B~     will assess recurrent GBM participants who receive weekly AMG 386 plus bi‐weekly bevacizumab~     (10mg/kg). Cohort B will start with a Phase I component to determine the MTD of AMG 386 that~     is safe when used in combination with bevacizumab. AMG 386 is administered intravenously,~     and, when used in combination with intravenous bevacizumab, will be administered first.~      Patients will be required to come to the clinic weekly for study drug administration.~      For study purposes, a cycle of therapy will be 4 weeks. Treatment will continue until either~     evidence of progressive disease, unacceptable toxicity, non‐compliance with study follow‐up,~     or withdrawal of consent.~      The estimated rate of accrual is 60 participants per year. The estimated date of accrual~     completion is 1.5 years from study initiation. The estimated date of study completion will~     be approximately 12 months from enrollment of the last study participant.~   "
134819|NCT01290250|"~     The purpose of this study is to evaluate the effects of a new orange juice-based beverage~     enriched in fiber and selected phenolic compounds (mainly flavanones) on features of~     metabolic syndrome and cardiovascular disease risk factors related to inflammation and~     antioxidant defense system in overweight and obese adult humans. This study hypothesizes~     that consumption of an orange juice-based beverage enriched in fiber and selected phenolic~     compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure~     and the Homeostatic Model Assessment (HOMA) index.~   "
134820|NCT01290237|"~     Vancomycin is an antibiotic administered to children or adults for many types of infections.~     While it has been used to treat infections of children for more than 50 years we are still~     not completely certain about the best dose to use when starting treatment with this~     medication.~      This study is intended to evaluate whether giving a new higher dose of vancomycin for the~     first dose will help us get to the desired amount in the body more quickly then the usual~     first dose. Half of the patients would get the new higher dose and the other half of~     patients will get the typical first dose. Only the first dose is changed and all doses that~     follow are the same in both groups and are doses typically used for children.~   "
134821|NCT01290224|"~     RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by~     chemotherapy.~      PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing~     peripheral neuropathy caused by chemotherapy~   "
134822|NCT01290211|"~     This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of~     14 healthy male and/or female subjects, to estimate the effect of maraviroc on the~     pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the~     pharmacokinetics of maraviroc.~   "
134823|NCT01290198|"~     The objective of this proof of concept study is to assess the involvement of~     epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia~     responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods~     for the study of functional microcirculation.~   "
134824|NCT01290185|"~     Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic~     therapy. The successful use of continuous peripheral nerve blocks provides sustained~     analgesia while minimizing the need for opioid analgesics throughout the postoperative~     period and avoiding the side effects associated with central neuraxial techniques. Excellent~     analgesia can be maintained and opioid-related side effects avoided allowing improved~     rehabilitation. However using existing methods a failure rate of >20% significantly limits~     the analgesic benefits in a substantial proportion leading to uncontrolled pain and side~     effects of opioid analgesics.~      A major concern with the use of continuous peripheral nerve blocks is difficulty in~     placement of the catheters close enough to the nerve to allow for effective local~     anaesthetic spread and therefore analgesia. The benefit of ultrasound to precisely place~     needles adjacent to nerves and increase efficacy of block success is undisputed. However~     ultrasound is of less help in accurately placing catheters. Indeed the final position of the~     catheter tip is not predictable and can be inadequate in 10%-50% of cases. The explanation~     for that is the material in currently used catheters is stiff and designed to avoid kinking.~     Unfortunately this same stiffness often leads to inadequate placement of the catheter tip.~     We have developed a catheter which coils up as soon as it is advanced beyond the needle tip,~     thus allowing the catheter tip to remain close to the initial needle tip position and~     therefore the nerve. The aim of this prospective randomized double blind controlled study is~     to determine the effectiveness of this new catheter in comparison with standard of care~     methods for continuous femoral nerve block commonly used after total knee arthroplasty. The~     primary outcome measure will be the incidence of catheter related block failure 24 hours~     after surgery. Our hypothesis is that the coiled catheter will significantly improve the~     efficacy of continuous femoral nerve block as compared to existing techniques.~   "
134825|NCT01290172|"~     This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to~     evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver~     transplantation. Patient systemic and hepatic dynamics will be collected and recorded at~     predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to~     perform liver biopsies at two different time-points to compare the liver structure and~     proteomic variations.~   "
134826|NCT01290159|"~     Today, the level of tolerance to heat is based on physiological strain indices, with no~     correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the~     formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the~     underling pathophysiology related to hyperthermia, can be used to identify~     tolerance/intolerance to heat. The aim of the present project is to develop a simple assay,~     based on specific designed sensitive biomarkers of OS that can be detected in a small blood~     sample, and to possibly correlate each individual's state of tolerance to heat to the level~     of OS. These biomarkers specially designed and synthesized to form a novel probe (not~     present as such in biological organs). The method will be based on the incubation of the~     suggested biomarkers with the patient's blood sample and the measurement of the level and~     type of oxidative alteration of the markers. For this goal, post heat stroke patients, with~     different levels of tolerance to heat and subjects during a process of acclimation to heat~     will be studied. Such a method will add to our ability to better determine the level of~     tolerance to heat and not rely only on the measurements of temperature and heart rate during~     an exercise-heat stress.~   "
134827|NCT01290146|"~     The purpose of this study is to compare in patients with Advanced Chronic Heart Failure the~     effects of Levosimendan versus diuretic (single 24-hour infusion) applied at the early~     detection of impending destabilization on hospitalization-free survival during 12 months.~      Patients with advanced chronic heart failure (ACHF) have a short term reduced life~     expectancy with recurrent hospital admissions for clinical exacerbations. Levosimendan~     improves contractility by calcium-dependent binding to troponin C, determines vasodilation~     of the coronary arteries and systemic resistance vessels, thus decreasing preload and~     afterload, while exerting a protective effect on the myocardium against ischemia-reperfusion~     damage. In randomized clinical trials of acute heart failure patients, levosimendan improved~     hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels,~     with no excess mortality The study will assess whether the administration of levosimendan~     (single 24-hour infusion) at the early detection of deterioration may reduce frequency and~     duration of hospital admissions, improve functional status and quality of life in ACHF~     patients, with respect to diuretic infusion.~   "
134828|NCT01290133|"~     The purpose of this study is to describe the safety and tolerability and pharmacokinetics of~     a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin~     (Captisol™) based, formulation in Healthy Adult Subjects.~   "
134829|NCT01290120|"~     The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy~     combination programme originally introduced by GMALL (the German cooperative group for adult~     acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free~     survival rates of adult patients with Burkitt's leukemia and lymphoma.~      The therapy includes a maximum of six chemotherapy courses (two with high doses of~     methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses),~     supplemented by local radiation therapy in the case of initial mediastinal or central~     nervous system (CNS) involvement or a residual tumor after chemotherapy.~   "
134830|NCT01290107|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is looking at bone marrow samples from patients with acute~     myeloid leukemia.~   "
134833|NCT01290055|"~     The yellow fever vaccine is a live, attenuated virus that results in a robust immune~     response, especially in the T cell compartment. We have been studying immune responses to~     live viral infections using the yellow fever vaccine as a model for a live viral infection.~     In this study, we are interested in looking at the processing and lifespan of yellow fever~     specific CD8 T cells.~      We plan to accomplish this by measuring DNA replication and cell proliferation in humans~     using a naturally occurring stable isotope called deuterium (D20). This technique has been~     used to track the turnover of a number of human cell types in vivo. We plan to use D20~     labeling to track YFV specific CD8+ T cells in human vaccinees who are positive for a~     specific HLA type, HLA A202.~      Deuterium labeled water (D2O), also known as heavy water is physically and chemically very~     similar to ordinary drinking water. In water, two hydrogen atoms bond to an oxygen and~     create H20. However in deuterated water, deuterium atoms replace the hydrogen atoms.~     Deuterium is a form of hydrogen that has an extra neutron. This neutron gives the atom extra~     weight, hence the name heavy water. This extra weight can be detected in the lab with very~     sensitive instruments. Scientists have been using heavy water as a tracer to gain a better~     understanding of animal and human metabolic rates. Deuterium is in fact already in the water~     we drink daily. It is not radioactive, and it occurs naturally at a concentration of about 1~     part per 5,000. Researchers have used heavy water since 1934 as a safe and effective tool in~     clinical trials.~   "
134834|NCT01290042|"~     To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy~     subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's~     disease.~   "
134835|NCT01290029|"~     The primary objective of the study was to evaluate the safety and tolerability of cinacalcet~     after a single oral dose in children aged 28 days to less than 6 years with chronic kidney~     disease receiving dialysis.~   "
134836|NCT01290016|"~     Children who are overweight or obese can develop many health complications including~     diabetes, high blood pressure, high cholesterol and they break their bones more often than~     children who are of healthy body weights. Recent short-term studies in children suggest that~     increasing milk intake for 16 weeks begins to improve body composition and also reduces risk~     of developing diabetes. However, no study has been long enough to truly test for the~     benefits of high milk consumption on these conditions including bone. Both dietary and~     activity approaches to reducing obesity in children are suggested by health professionals~     and when combined are called lifestyle interventions. Therefore, McGill University has~     designed a 1-year intervention study focused on lifestyle improvements to reduce obesity in~     children 6 to 12 years of age. A control group will be monitored for the year, while two~     other groups will receive lifestyle interventions with standard recommended (2 servings a~     day) and high (4 servings a day) intakes of milk. The intervention will include 6 planning~     sessions to increase intakes of vegetables, fruits and milks along with more activity and~     less time watching television or using computerized games. Children will have muscle and fat~     measured using an x-ray device that also measures bone at the beginning, middle and end of~     the study. They will also have a small blood sample taken every 3 months to measure blood~     sugar, cholesterol and some nutrients. Changes over the study will demonstrate the benefits~     of lifestyle and milk interventions.~   "
134837|NCT01290003|"~     The purpose of the study is to evaluate the role of antibiotics in preventing infection in~     babies born through meconium stained amniotic fluid. Normally babies do not pass meconium~     while in utero. In response to hypoxic stress babies may pass meconium before birth and are~     likely to be candidates for problems related to meconium passage and its inhalation. It is~     believed that these babies are more prone to infections as meconium enhances bacterial~     growth and may predispose such babies to secondary bacterial infections. In addition,~     meconium passage has been incriminated as a pointer of in-utero infection. Whether use of~     antibiotics in babies born through meconium stained amniotic fluid will reduce the~     infectious episodes and complications thereof or not is not clear. Moreover, there is not~     much published literature to prove or refute the same. Most clinicians have a low threshold~     for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage~     in these babies, the investigators decided to investigate the role of prophylactic~     antibiotics in prevention of neonatal sepsis in babies born through meconium stained~     amniotic fluid.~   "
134838|NCT01289990|"~     This study will investigate the efficacy and long term safety and tolerability of BI 10773~     in type 2 diabetic patients.~   "
134839|NCT01289977|"~     Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is~     to evaluate the human immune response to uninfected laboratory raised sand fly bites and~     select from the immune response to sand fly saliva, possible substances to use for a future~     vaccine to protect against the parasite leishmaniasis.~   "
134840|NCT01289964|"~     The study aims to investigate the influence of 5 dry cupping treatments on chronic non~     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and~     waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck~     pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the~     quality of life (SF36). To investigate neurophysiological effects of cupping we also measure~     mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain~     threshold (PPT) at pain related and control areas. The treatment group then receives 5~     cupping treatments over a period of two weeks. After the cupping series resp. a waiting~     period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated~     (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by~     the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping~     treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to~     changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control~     group.~   "
134850|NCT01289834|"~     The purpose of this scientific study is to compare early migration of hip prostheses in~     respect to the bone in order to determine whether there is a clinical difference between the~     two investigated bone cements (which one is best suited for cementation of hip prostheses).~   "
134871|NCT01289561|"~     The purpose of this study is to investigate the effects of caffeine on the~     self-administration of alcohol. The study will also examine the combined effects of alcohol~     and caffeine on behavioral performance, participant ratings of behavioral performance, and~     self-reported subjective effects.~   "
134841|NCT01289951|"~     Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly~     efficacious and well tolerated in phase III clinical trials in multidrug experienced human~     immunodeficiency virus(HIV)-infected patients, as well as initial therapy in untreated~     patients. Pharmacokinetic studies in healthy adult subjects indicate that the major~     mechanism of clearance of the drug is glucuronidation mediated by UGT1A1, with a minor~     contribution of renal excretion of unchanged parent compound. Unlike CYP-based metabolism,~     glucuronidation is generally found to be relatively unaffected by hepatic disease. A single~     dose pharmacokinetic study of raltegravir in patients with mild to moderate hepatic~     insufficiency (Steigbigel et al. 2008) found no clinically important effect on the drug~     pharmacokinetic profile, with no dosage adjustment being necessary. The liver safety and~     tolerability of boosted atazanavir (ATV/r) has been evaluated in human immunodeficiency~     virus and hepatitis C virus (HIV/HCV) coinfected patients with advanced liver disease~     (decompensated cirrhosis) (Hermida JM et al. 4th IAS: Sidney, 2007). Similar to Raltegravir,~     ATV is also mainly metabolized by conjugation through UGT1A1. There is an urgent need for~     potent and efficacious ARV drugs with a clean safety liver profile even in patients with~     severe liver disease. The investigators hypothesized that pharmacokinetics will not be~     altered in HIV/HCV patients with advanced (Child-Pugh grade C) cirrhosis or in those with no~     histologic liver damage.~   "
134842|NCT01289938|"~     Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and~     Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to~     polymorphisms of CYP2D6~   "
134843|NCT01289925|"~     Serum levels of inflammatory mediators increase with age and are strongly associated with~     the most common and the most devastating health conditions found in older adults including~     frailty, chronic disease, disability and increased mortality. Even though the processes that~     contribute to increased inflammatory mediators are likely not completely reversible in older~     adults, the development of a safe and effective intervention that modulates inappropriate~     inflammatory responses could be a very important component of prevention against frailty and~     other adverse health outcomes. As part of an ongoing effort to identify molecular and~     physiologic triggers of inflammation in older adults, the investigators recently identified~     a highly significant inverse relationship between the anti-oxidant micronutrient selenium~     and the inflammatory mediator IL-6, as well as a significant relationship between selenium~     and all cause mortality in a population of community dwelling older women with selenium~     levels well below the mean for the overall American population. Based on our findings in~     older adults and on data from other studies that suggest that selenium interventions are~     effective in targeted populations with inflammatory conditions, the investigators~     hypothesize that selenium supplementation targeted to a population of older adults with~     increased inflammatory markers and low normal selenium levels will in the short term reduce~     inflammation as measured by serum IL-6, and in the long term will reduce the incidence and~     prevalence of inflammation associated poor health outcomes of frailty, disability, and~     mortality in vulnerable older adults.~   "
134844|NCT01289912|"~     Tuberous Sclerosis Complex (TSC) is a multi-system disease, usually presenting with~     seizures, mental retardation and autism, and exhibiting a high variability in clinical~     findings both among and within families. Investigators are doing research in order to~     identify possible neurocognitive benefits from treatment with RAD001 or placebo for a six~     month period. There may also be potential for improvements in seizure frequency, sleep and~     autistic behaviors. We hope this trial will lead to a better understanding of TSC and to new~     forms of treatment, to benefit children and adults with TSC in the future.~      Individuals diagnosed with TSC will be asked to participate in this study if they are~     between the ages of 6 and 21 years of age and have an IQ of greater than or equal to 60.~     Both males and females will be asked to participate. Additionally, to be eligible for study~     participation, individuals must have been on the same seizure medication(s), if applicable,~     for at least 6 months. Individuals must also be able to participate in neuropsychological~     testing and meet certain medical criteria. They will need to sign an informed consent. If~     enrolled in the study, participants will have a number of screening tests to help determine~     if they are eligible for participation in the clinical trial. If eligible for the treatment~     phase of the trial, they will be asked to take either the study drug or a placebo (pill with~     no medicine), which is determined by chance.~      The study involves about 9 visits, 3 of which can be done locally, over a six month period,~     as well as follow-up calls with our research nurse. Study visits will vary in length.~     Screening, three month and six month visits may last up to 8 hours, while all other visits~     will be less than 2 hours. The study visits include blood draws, laboratory tests and~     neuropsychological assessments. There is no fee to participate in this study. Some~     compensation may be available for travel costs of out-of-state participants based on fund~     availability. The study drug will be provided at no charge during the study.~      After all study data has been analyzed, families will be informed of the overall results.~     Treatment on this study may or may not improve a child's learning skills (neurocognition).~     Future patients may benefit from what is learned.~   "
134845|NCT01289899|"~     The objective of this study is to determine the safety and tolerability and to determine the~     Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in~     healthy male subjects.~   "
134846|NCT01289886|"~     The objective of this study is to determine the safety and tolerability and to determine the~     Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in~     healthy male subjects.~   "
134847|NCT01289873|"~     The purpose of this study is to determine how common oral HPV infections are in college~     women. The investigators also will find out what risk factors are associated with having~     oral HPV infections. The investigators hypothesize that approximately 3% of women will have~     oral HPV, and that HPV will be associated with oral sexual behaviors and with smoking~     behaviors. Finally, for those women with oral HPV- the investigators will determine whether~     the infections are persistent (still present) at 3-, 6-, and 12-months after the initial~     diagnosis.~   "
134848|NCT01289860|"~     This study was a controlled, cross-over, acute flavonoid intervention trial with younger and~     older adults. Subjects consumed a blueberry beverage during one visit and a control beverage~     on another. Cognitive function pre drink was assessed, blood and urine samples were taken as~     well as blood pressure and a measure of vascular reactivity. These outcome measures were~     taken at 2 and 5 hours post drink.~      It was predicted that the flavonoids in the blueberry drink would lead to improved~     performance on the cognitive tests and vascular reactivity measure compared to following the~     control drink. It was thought this could be due to increased vaso-dilation and improving~     blood flow to the brain which was investigated in an extension to the project where a sample~     of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a~     control drink.~   "
134849|NCT01289847|"~     The main objective is to determine the efficacy of Gammaplex by measuring the number of~     serious acute bacterial infections during treatment with Gammaplex over a 12 month period.~     The secondary objectives are to assess the safety and tolerability of Gammaplex and to~     compare the data collected from adult subjects with PID from the GMX01 study~   "
134851|NCT01289821|"~     This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when~     given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with~     metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an~     oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets~     certain key proteins that are essential for the survival of the cancer cell. By specifically~     targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be~     decreased by preventing these specific proteins from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on~     the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy~     of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response~     rate observed for the standard therapy only.~   "
134852|NCT01289808|"~     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the~     beneficial effects extend to care giving procedures that are performed after painful~     procedures. The investigators objective is to determine the effect of glucose 25% analgesia~     for procedural pain on infant pain responses during a subsequent care giving procedure.~   "
134853|NCT01289795|"~     The purpose of this study is to determine whether levels of circulating endothelial~     progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.~   "
134854|NCT01289782|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in participants who are infected with genotype 1 hepatitis C virus who have~     never received treatment before. Participants will also receive peginterferon alpha-2a and~     ribavirin as part of their treatment.~   "
134855|NCT01289769|"~     The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic~     responses during laryngoscopy and double lumen endotracheal intubation and assess the~     adverse effect related to complications of dexmedetomidine.~   "
134856|NCT01289756|"~     Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of~     Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.~   "
134857|NCT01289743|"~     The study has the aim to investigate the efficacy and safety of etanercept in patients with~     active ankylosing spondylitis (AS) over 520 weeks.~   "
134858|NCT01289730|"~     The study has the aim to investigate the efficacy and safety of etanercept in patients with~     active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.~   "
134859|NCT01289717|"~     There is a need to develop blood and/or urine tests that will help to detect early signs of~     rejection in people who have had kidney transplant. Researchers will examine blood, urine,~     and tissue samples and try to identify genetic markers for certain conditions like~     rejection, response to therapy, and scarring of the kidney. By studying gene patterns,~     researchers hope to be able to diagnose these conditions earlier and improve kidney~     survival.~   "
134860|NCT01289704|"~     Charcot−Marie−Tooth neuropathy type 1A (CMT1A) is one of the most common inherited~     neurological disorders. The study will evaluate the efficacy and safety of an innovative~     rehabilitation protocol constituted by exercises at the treadmill and by a stretching and~     proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in~     a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A~     the study will be multicentric and will comprehend four of the most active clinical centers~     in the field of CMT, in Italy. People with CMT1A are very motivated in entering~     rehabilitation protocols because to date there is no effective therapy for this disease.~     Therefore, the investigators expect a high compliance by the patients. With the present~     project the investigators plan to clarify several unanswered questions: 1) the efficacy and~     safety of treadmill over a more conventional protocol; 2) the duration and frequency of any~     rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of~     rehabilitation approach in patients with CMT.~   "
134861|NCT01289691|"~     Patients scheduled for lung lobe resection using video assisted thoracic surgery will be~     randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.~      The primary purpose of this study is to determine if the incidence of postoperative collapse~     (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to~     using only oxygen (which is our control measurement) during one-lung ventilation.~   "
134862|NCT01289678|"~     Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment~     during lymphocyte recovery.~   "
134863|NCT01289665|"~     The purpose of this study is to determine if lubricating gel affects patients' perception of~     discomfort during speculum insertion, as compared to water.~   "
134864|NCT01289652|"~     The aim of the study is to investigate the epidemiology, natural history and treatment~     outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting,~     the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients,~     but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable~     comparisons to be made as appropriate and possible.~   "
134865|NCT01289639|"~     The study is designed to investigate the relationship between insulin resistance and~     non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying~     insulin resistance in NAFLD by determining associations between hepatic and peripheral~     insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose~     metabolism, beta-cell function and body fat distribution.~   "
134866|NCT01289626|"~     The research question and primary aim is to determine if lanthanum carbonate is effective in~     treating calciphylaxis by measurement of complete or partial remission of skin lesions.~     Secondary endpoints will be measured to determine if lanthanum carbonate can lower~     calcium-phosphorus product levels, intact PTH and mortality. Albumin levels will be measured~     as a marker of nutritional status and inflammation.~   "
134867|NCT01289613|"~     BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS~     bilaterally revealed side differences in previous studies. This study investigates the~     incidence of clinically relevant side differences of BIS during maintenance and emergence~     from anesthesia for ENT surgery in both adults and children.~   "
134868|NCT01289600|"~     The purpose of this study is to demonstrate that mechanical ventilation guided by the~     diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior~     compared to pressure support and pressure control ventilation.~   "
134873|NCT01289535|"~     This study is the first step in a clinical research program that aims to study the immune~     response to influenza vaccine in the elderly and then to propose a new method of~     administering the vaccine.~      Influenza can cause severe complications in patients at risk (elderly and subjects~     vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza~     occur in people aged over 65 years.~      Vaccination is the most effective way to prevent infection. The World Health Organization~     recommends annual immunization for people at risk, including all persons aged over 65 years,~     to reduce the risk of morbidity and mortality related to influenza.~      However, the immune response to influenza vaccine appears to be lower in elderly than in~     young people.~   "
134874|NCT01289522|"~     PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line~     treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.~     Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck~     cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination~     named TPEx as first-line treatment in this setting.~   "
134875|NCT01289509|"~     The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of~     E5501 40 mg tablets administered twice as single oral doses to healthy subjects.~   "
134876|NCT01289496|"~     Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a~     category of patients for whom there is currently no worthwhile therapeutic alternative.~      Several studies have shown that there is a relation between plasma ribavirin concentrations~     and treatment response. Adequate ribavirin plasma concentrations, especially during the~     first 12 weeks of treatment, should be associated with a better chance of response to the~     treatment.~      The strategy for this study will be to use a loading dose of ribavirin before beginning the~     treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be~     reached, and possibly improving the effectiveness of the treatment.~   "
134877|NCT01289483|"~     Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult~     airway will be consented prior to intubation ASA Physical Status classification and history~     of difficult intubation will be recorded at screening. The investigators will also record~     the results of airway examination including Mallampati classification, thyromental distance,~     mouth opening, neck circumference, neck range of motion, presence or absence of beard and~     overbite, history of neck radiation, and mandibular protrusion test Informed consent will be~     obtained prior to the procedure from those patients who meet the inclusion and exclusion~     criteria.~      Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure,~     heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of~     Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation.~     Two consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate~     sedation.~      For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be~     delivered through nasal canula until the completion of the AFI procedure. Patient head will~     be positioned in the sniffing position, Topical anesthesia would be achieved using the~     topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2%~     xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not~     exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment~     arms: 2, 3.5, 5, or 6.5 mg/kg~   "
134878|NCT01289470|"~     An observational study designed to evaluate the performance of a new Near Infrared~     Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral~     sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be~     enrolled and tissue oximetry measurement will be collected throughout the surgical procedure~     and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and~     skeletal tissue will be added to the standard intra-operative patient monitoring. Measures~     of delirium will be collected using a standardized questionnaire. The relationship between~     cerebral oximetry measures and delirium scores will be explored.~   "
134879|NCT01289457|"~     The goal of this clinical research study is to learn if the combination of clofarabine,~     idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine~     can help control AML and MDS. The safety of these study drug combinations will also be~     studied.~   "
134880|NCT01289444|"~     Our goal is to advance palliative care to adolescents and their families. We hope our study~     will decrease suffering (psychological, spiritual, physical) and increase quality of life~     (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may~     result in families being charged with neglect or court battles over treatment choices.~     FAmily CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and~     their families for future medical decisions. We hope to increase families' understanding of~     their teens' wishes for end-of-life care and to decrease conflict. We will also study~     communication and spiritual struggle Families will be randomized into the either the Control~     (N=65 families) or FACE Intervention (N=65 families). FACE families will meet with a~     trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart:~     Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session~     2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control~     families will also meet with a researcher for three 60-to 90-minute sessions scheduled one~     week apart: Session 1: Developmental History, Session 2: Safety Tips, and Session 3:~     Nutrition. Questionnaires will be administered five times, when first seen, at 3, 6, 12 and~     18 months from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will~     relieve psychological suffering by 1) increasing congruence in treatment preferences between~     teens with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL~     decision making for future medical treatment in adolescents with AIDS; 3) increasing quality~     communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and~     maximizing QOL.~      Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL~     through dimensions of threat appraisal.~      Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have~     less spiritual struggle.~      Hypothesis 4: Spiritual struggle has both direct and indirect effects on~     hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly~     through threat appraisal and HAART adherence.~   "
134881|NCT01289431|"~     The objective of this study is to evaluate the dose response, and efficacy of Mapracorat~     ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs~     associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.~   "
134891|NCT01289301|"~     Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to~     graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study~     the best way to manage viral invasion by changing the immunosuppressive treatment comparing~     two treatment schemes. The investigators hypothesis is that switching to an mTOR-based~     scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The~     study will be performed as a prospective, randomized, parallel group comparison.~   "
135543|NCT01280734|"~     This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study~     investigating the effect on night time awakening body sway of melatonin and zolpidem in~     healthy adult subjects aged of 55 to 64 years.~   "
134882|NCT01289418|"~     Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or~     drifts, and its safety profile may vary. While generally considered safe, influenza vaccines~     have been associated in the past with increases in cases of Guillain-Barré syndrome (1976)~     or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza~     virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination~     campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health~     Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine.~     While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000~     people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical~     trials before the mass campaign was launched. With this small number, adverse events~     occurring at a rate < 1% will not be detected by these clinical trials.~      Considering that most cases of pH1N1 to date have been relatively mild, it will be~     imperative to rapidly detect adverse events serious enough to reconsider the use of the~     vaccine. Passive surveillance is collecting notifications of adverse events but the~     sensitivity of this system is not high and its timeliness is not necessarily optimal.~      In Canada, healthcare workers (HCW) are among those who were offered the new pandemic~     vaccine in priority. Because they were offered the vaccine early in the campaign and because~     they constitute a well-defined group in good general health, this group of people may be~     well suited for monitoring the safety of the pH1N1 vaccine.~      The main objective of this project was to estimate in HCW vaccinated against pH1N1 the~     frequency of adverse events of sufficient severity to cause work absenteeism or medical~     consultation.~      The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in~     the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City~     (Quebec): 3 hospitals, (3) Toronto~   "
134883|NCT01289405|"~     Objective: to evaluate the effects of a speech therapy exercises program in the treatment of~     Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography~     (PSG) parameters.~      Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index < 35~     kg/m2 and scores of Epworth Sleepiness Scale > 9. Patients will be divided into four groups:~     I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent~     placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent~     speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or~     placebo. The speech therapy include isometric and isotonic exercises to improve posture,~     mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of~     tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck,~     without therapeutic purpose. Both therapies are applied for three months, three times a day,~     lasting 20 minutes each session. During the treatment, the subjects will be monitored in~     weekly meetings, for orientation and description of the exercises and return of the~     fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns~     after one week, a month and at the end of the study. Conduct assessments before and after~     treatment and after twenty one days washout, including: assessing the upper airway,~     anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires~     (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring),~     Psychomotor Vigilance Test and PSG.~   "
134884|NCT01289392|"~     Introduction: It is unclear whether exercise training with or without Continuous Positive~     Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of~     Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.~      Objective: In patients with moderate OSA, the investigators will evaluate the effect on the~     subjective and objective measures of sleep, quality of life and mood of different forms of~     treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP~     and OA; treatment with CPAP and treatment with OA.~      Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index~     (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9)~     will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE;~     n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete~     two months of treatment with CPAP or OA to examine the separate effects of these devices. As~     the patients of the E group did not use the CPAP but will undergo four months of exercise~     training. After this initial step, patients in CE and AE groups will undergo four months of~     exercise training associated with CPAP or OA. The investigators will evaluate the subjective~     sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep~     diaries) and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire~     Profile of Mood States (POMS) and anthropometric measurements (neck circumference and body~     composition), the incremental exercise test (ergospirometry) and the one Repetition Maximum~     test (1RM).~   "
134885|NCT01289379|"~     Investigators conducted a randomised perspective study to determine whether the use of HFJV~     instead of conventional mechanical ventilation will reduce the adverse cardiovascular~     effects of pneumoperitoneum during laparoscopic surgery.~   "
134886|NCT01289366|"~     Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine~     the extent and severity of the disease for further specific therapy. Nevertheless, despite~     ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still~     relies on the interpretation of histopathological features of intestinal biopsies taken~     during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new~     endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the~     gut at a magnification level of up to 1400-fold.~   "
134887|NCT01289353|"~     The purpose of this study is to determine the safety and effectiveness of a combination of~     chemotherapy and radiotherapy in breast cancer patients after breast surgery.~   "
134888|NCT01289340|"~     the aim of the study is to compare between two advanced wound dressing and conventional~     dressing for the primary ER treatment of superficial partial thickness burns~   "
134889|NCT01289327|"~     Although propofol is a popular agent for sedation during flexible bronchoscopy, some~     clinicians have raised concerns that it may cause greater respiratory drive reduction than~     more common drugs. However, this factor is difficult to accurately examine with pulse~     oximetry. The introduction of a novel device that noninvasively measures carbon dioxide~     (CO2) levels can help to resolve this controversy. The aim of this study is to evaluate the~     safety of conscious sedation with midazolam+alfentanil compared to propofol.~   "
134890|NCT01289314|"~     Objective: To compare the occurrence and intensity of pelvic pain as well as patient~     satisfaction and quality of life after total laparoscopic and laparoscopic supracervical~     hysterectomy.~      Design: Prospective randomised trial.~      Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic~     pain following TLH compared with following LSH.~      Null hypothesis 2: There is no significant difference in patient satisfaction and quality of~     life following TLH compared with following LSH.~   "
134892|NCT01289288|"~     The objective of this study is to test whether a culturally-tailored in-office based~     intervention have impact on increasing Chinese physician's recommendation of colorectal~     cancer (CRC) screening to their nonadherent Chinese patients.~      Special aims are to:~        1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing~          non-adherent Chinese American's patients' CRC screening rate.~        2. Identify factors that mediate or moderate the intervention effects. For example,~          patients who hold an eastern cultural view or are less acculturated will be more likely~          to benefit from the intervention than patients who hold a western view or who are more~          acculturated.~   "
134893|NCT01289275|"~     When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most~     of them, however, go back to smoking soon after discharge. This study will test an~     innovative approach which includes dispensing nicotine patches at discharge, providing~     proactive telephone counseling post discharge, or giving a combination of the two. The~     interventions are aimed at increasing the long term quit rate of these patients.~      The specific aims of the study are to demonstrate the effects of two interventions,~     dispensing nicotine patches at discharge and providing proactive telephone counseling soon~     after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.~   "
134894|NCT01289262|"~     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology~     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S~     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in~     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,~     ...) are very important issues. Classically Kerr incision is repaired with continuous locked~     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in~     turn may reduce short and long term complications. For this reason, the investigators aimed~     to compare two closure techniques.~   "
134895|NCT01289249|"~     The object of the study is to investigate whether all included patients receive treatment~     that is effective against all bacteria that are defined as sensitive to meropenem with the~     current treatment regimen. Will the investigators findings motivate routine monitoring of~     plasma concentrations in children receiving meropenem? Up to 50 patients will be included in~     the study, and all participants are children.~   "
134896|NCT01289236|"~     The purpose of this study is to compare the safety and efficacy of multiple doses of~     Milnacipran to a placebo dose in subjects with Chronic Shoulder Pain.~   "
134897|NCT01289223|"~     To compare the efficacy of bendamustine against treatment of physician's choice on~     progression-free survival in subjects with indolent B-cell NHL.~   "
134898|NCT01289210|"~     This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug~     that stimulates the immune system) in combination with radiation therapy in treating~     patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy,~     and 9 intratumoral injections of VTX-2337 over the course of 3 months.~   "
134899|NCT01289197|"~     The primary goal of this project is to examine the short and long-term effects of an~     intervention focusing on three interrelated dimensions of health: improving sleep,~     increasing physical activity, and improving skills in emotion regulation. This intervention~     targets high-risk youth at a key neuromaturational period—early adolescence—when many~     individuals are experiencing new challenges to regulatory systems involved in sleep,~     activity, and emotion regulation. This maturational period is also a crucial time in the~     normal development of habits, skills, and proclivities in each of these domains. Thus, early~     adolescence presents unique opportunities for intervention targeting these three~     interrelated regulatory systems. Participants will include 200 9-13 year-old children who~     are siblings of children enrolled in one of three ongoing studies of vulnerability and~     resilience, whose families were initially identified on the basis of sociodemographic,~     child, and/or family risk or are recruited thru local Family Centers. Children will be~     selected as having difficulties in at least one of these domains (sleep, sedentary behavior,~     or emotion regulation) and then randomly assigned to either a control or intervention group.~     All families will receive baseline, one- and two-year follow-up assessments of child sleep,~     physical activity, and emotion regulation. Families in the intervention group will have the~     opportunity to receive feedback and intervention services on these three child domains and~     other parenting and family issues (e.g., parent involvement, parent self-care, school~     problems) following the initial assessment and the one-year follow up. The intervention will~     involve the parent and target youth receiving feedback about the child's current status in~     these areas and family functioning. If desired, the family will also participate in~     follow-up meetings with the parent and/or target youth to improve the youth's sleep,~     physical activity, and/or emotion regulation skills, as well as aspects of the family~     environment. The investigators hypothesize that the intervention will be associated with~     improvements in sleep, physical activity, and emotion regulation among those in the~     intervention group, as well as improvements in measures of social, behavioral, and affective~     function. Finally, the investigators will explore the possibility that increases in parental~     involvement mediate some of the changes found in child sleep, physical activity, and emotion~     regulation.~   "
134900|NCT01289184|"~     To monitor air quality in selected photocopier units and to assess the health status of~     workers who are exposed to emissions from photocopiers.~   "
134901|NCT01289171|"~     Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat~     warts that have been recalcitrant to multiple treatments.The aim of this prospective study~     was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion~     (NeoStrata) for treatment of flat warts in HIV-positive children in Botswana. Additionally,~     the investigators characterized the flat warts in this population, including Human~     Papillomavirus (HPV) type(s) and degree of immunosuppression within the patients.~   "
134902|NCT01289158|"~     The investigators are interested in learning more about the changes found in the condition~     called Combined elevation of Malonic and MethylMalonic Acid, or CMAMMA.  Malonic, or MA~     and MethylMalonic, or MMA, are acids formed from the breakdown of protein under normal~     conditions. However, in the condition called CMAMMA there is an increase of these acids in~     the blood and urine, which is not normal.~      Some people with high MA and MMA in their blood and urine have a serious disease, starting~     as a baby or young child that includes heart disease and problems in learning. These people~     have changes in a special enzyme called Malonyl CoA Decarboxylase (MCD). Other people who~     have a high level of MA and MMA do not have any obvious illness. The investigators are not~     sure why they have high levels of MA and MMA and why they are not sick.~      The goal of this study is to learn more about why some people have a high level of MA and~     MMA and to make sure there are no medical problems as a result of these high levels. The~     investigators also want to find out which gene and enzyme cause the high levels of MA and~     MMA.~   "
134920|NCT01288924|"~     The purpose of this study is to compare the efficacy of parecoxib with placebo on the~     incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement~     for relieving severity of postthoracotomy shoulder pain and adverse events associated with~     treatment.~   "
134921|NCT01288911|"~     The purpose of this study is to determine the efficacy and safety of oral enzalutamide~     compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed~     while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a~     bilateral orchiectomy.~   "
134903|NCT01289145|"~     The purpose of this study is to increase regular physical activity among students by~     fostering self-management competencies. The intervention was implemented as paper-pencil~     intervention. The aim of this research project is to evaluate a motivational and volitional~     intervention in comparison to a control intervention.~      Study participants will be recruited in lectures at Freie Universitaet Berlin and followed~     up twice (two and ten weeks after baseline).~      The motivational intervention is expected to increase unmotivated participants' intention to~     be physically active. The volitional intervention is expected to promote physical activity~     among motivated but inactive participants. Both interventions are hypothesized to improve~     self-management competencies over time.~   "
134904|NCT01289132|"~     The purpose of this study was to evaluate the dose-response relationships of azilsartan,~     once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.~   "
134905|NCT01289119|"~     The purpose of the study is to determine the efficacy of alogliptin compared to placebo when~     given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without~     metformin).~   "
134906|NCT01289106|"~     The purposes of this study include 1) to compare the seroconversion rate of an intensive~     standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months),~     and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at~     0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in~     HIV-infected adult patients.~   "
134907|NCT01289093|"~     LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a~     good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a~     disease-specific quality of life questionnaire, designed by an American group, to monitor~     quality of life in patients undergoing operation for hernias.~      The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores~     for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality~     of life and other well-known core-symptoms before and after herniotomies.~   "
134908|NCT01289080|"~     This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1~     group of subjects with normal renal function and 1 group of severely renally impaired~     subjects.~   "
134909|NCT01289067|"~     The purpose of the study is to test genes for BRCAness(BRCA[BReast CAncer] gene) Studying~     these genes could help predict which patients would benefit from treatment with satraplatin,~     a medication being used for subjects who have failed prior chemotherapy. All subjects will~     have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene~     signature may be able to predict response to satraplatin and a tool will be developed to be~     able to screen patients likely to benefit from satraplatin. Subjects will all receive~     Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be~     evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered~     responders if they have measurable disease meeting criteria for partial or complete~     response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35~     days.~   "
134910|NCT01289054|"~     This is a voluntary, international, primarily prospective, observational, exposure-registry~     and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six~     months prior to pregnancy.~   "
134911|NCT01289041|"~     This is a prospective multi-center, open-label, single arm, Phase II study to investigate~     the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose~     disease progressed on or after a first-line antineoplastic treatment. Patients will receive~     BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival~     tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K~     (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.~   "
134912|NCT01289028|"~     This study will evaluate the preliminary efficacy of nilotinib in pretreated patients~     (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.~   "
134913|NCT01289015|"~     The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once~     daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with~     tinea pedis.~   "
134914|NCT01289002|"~     The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix~     Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.~   "
134915|NCT01288989|"~     A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5~     in subjects with advanced solid tumors that are refractory to standard therapy or for which~     no standard therapy is available.~   "
134916|NCT01288976|"~     The MitraClip System enables the European physicians an alternative therapeutic option for~     patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac~     surgery, and palliative medical therapy with or without device therapy. The study will~     observe the outcomes of patients treated with the MitraClip System throughout 12-months as~     compared to the outcomes of patients treated by alternative therapies.~   "
134917|NCT01288963|"~     The purpose of this study is to determine which participants with melanoma have a better~     response to IL-2 and to identify markers that may predict response to IL-2 by collecting~     participant information (for example; cancer diagnosis and history, prior treatments for~     cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after~     treatment.~   "
134918|NCT01288950|"~     The purpose of this study is to determine whether a single oral dose of vitamin D given to~     infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response~     to BCG vaccination.~   "
134919|NCT01288937|"~     Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous~     system. Serotonin and noradrenaline are molecules made by the brain that affect how your~     body responds to pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor~     has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to~     treat patients with painful peripheral neuropathy. Many clinical trials for neuropathy pain~     are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common~     cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber~     neuropathies. The information in this study will provide information on whether milnacipran~     also provide benefit as a medication for neuropathic pain.~   "
134924|NCT01288872|"~     The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized~     or broken down differently when women are pregnant versus not pregnant. PZQ is used to treat~     schistosomiasis (worm infection). Researchers will study how PZQ is broken down among 15~     women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women~     nonpregnant women who are producing breast milk. All women will be 18 or older and otherwise~     healthy. The usual practice is to wait until after mothers have finished pregnancy and~     breast feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3~     hours. Study procedures will include a 24 hour hospital stay following administration of~     PZQ, blood, stool and urine samples, ultrasound if pregnant, and physical exams of mother~     and baby. Patient participation for mother/infant pair is about 9 months.~   "
134925|NCT01288859|"~     Polyphenolic compounds exert several health benefits depending on bioavailability.~     Encapsulation may improve bioavailability of these compounds.This study will evaluate~     bioavailability of some polyphenols (curcumin and cocoa polyphenols) from new~     enriched-foods. In particular bread and nut based creams will be used as food matrices to~     include free or encapsulated polyphenols.~   "
134926|NCT01288846|"~     30 patients acute hospitalized to medical ward and their medication records are examined. It~     is to be recorded how the investigators find information about medicine use by the reception~     when they do not follow the patient. The record of the changes made during hospital stay is~     examined, whether they are justified in the discharge summaries and whether they are~     described in the medical list. After a month is to find out if the GP has recorded or~     possibly rejected changes to medication made in hospital.~   "
134927|NCT01288833|"~     The investigators hypothesize that high definition colonoscopy with close focus narrow band~     imaging features has a high diagnostic accuracy for colorectal polyp histology, and can~     replace formal pathologic assessment in cases of high diagnostic confidence.~   "
134928|NCT01288820|"~     This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium~     vivax malaria during November 2010 to March 2012. The aim of the study is to compare the~     efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and~     dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria.~     The significance of the study is to find alternative drug for treating patients with vivax~     malaria in case the standard treatment is not available or become resistance. This study~     will give thorough information about the efficacy and safety of 2 artemisinin-based~     combination therapies (ACTs) in combination with primaquine. It will also inform the~     Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria,~     and provides evidence based treatment options for chloroquine resistant vivax malaria. This~     study will also provide information about prevalence of glucose-6-phosphate dehydrogenase~     (G6PD) deficiency and G6PD variants in North Sumatera population.~   "
134929|NCT01288807|"~     The investigators want to study the effects of milnacipran treatment on neurotransmitter~     release in fibromyalgia.~   "
134930|NCT01288794|"~     Ascites is the most frequent complication of liver cirrhosis and carries a significant~     worsening of the prognosis. Approximately 10% of patients per year develop refractory~     ascites because of either the lack of response to medical treatment or the onset of~     diuretic-induced complications that preclude the use of an effective dosage. Refractory~     ascites is associated with an increased incidence of severe complications of cirrhosis.~     Thus, the overall probability of survival of patients with refractory ascites is very poor,~     being approximately 30% at 2 years. Repeated large-volume paracentesis, transjugular~     intrahepatic portosystemic shunt (TIPS), and liver transplantation represent the therapeutic~     alternatives for refractory ascites. As renal sodium retention and ascites formation are the~     consequence of portal hypertension and effective hypovolemia, the preservation of the~     central blood volume represents a major purpose in the management of patients with advanced~     cirrhosis. Although albumin is responsible for about 70% of the plasma oncotic pressure, the~     absence of large multicenter randomized studies together with its high cost explains why~     albumin infusion is not usually included among the therapeutic options for~     difficult-to-treat ascites.~      The objective of the present study is to define the effectiveness of the prolonged~     administration of human albumin in the treatment of liver cirrhosis with ascitic~     decompensation. This goal will be reached by performing a multicenter, prospective,~     randomized clinical trial comparing the efficacy of chronic albumin administration on top of~     standard medical treatment versus standard medical treatment alone in patients with~     cirrhosis and ascites.~      The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or~     out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized~     with a ratio of 1:1. The duration of the study for each patient is 18 months from~     randomization. The enrolment of patients will last 18 months and will be competitive between~     centers. Treatment will be interrupted if one of the following condition occur: orthotopic~     liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient~     refusal to continue, and medical judgement.~      An ancillary optional study will be performed in a subset of patients to analyze the~     non-oncotic properties of albumin.~   "
134931|NCT01288781|"~     The purpose of this study is to determine whether increased pressure in the head is elevated~     in people who suffer from High Altitude Headache. We hypothesise that head pressure will be~     elevated in people with High Altitude Headache.~   "
134932|NCT01288768|"~     The purpose of this study is to determine whether a knee arthroscopy is effective in the~     treatment of middleaged patients with meniscal symptoms also receiving a standardised~     exercise program.~   "
134933|NCT01288755|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of~     TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug~     has been given long enough so that the plasma levels will remain at about the same level~     with each subsequent dose. TMC278 is being investigated for the treatment of human~     immunodeficiency virus (HIV) infection. Raltegravir is a commercially available~     antiretroviral drug for treatment of HIV infection. Pharmacokinetics (PK) means how the drug~     is absorbed into the bloodstream, distributed in the body and eliminated from the body.~   "
134934|NCT01288742|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a~     single dose of digoxin or rosuvastatin on the steady-state pharmacokinetics of TMC435.~     Steady state is a term that means that the drug has been given long enough so that the~     plasma concentrations will remain the same with each subsequent dose. TMC435 is being~     investigated for the treatment of chronic hepatitis C virus (HCV) infection.~     Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in~     the body, and eliminated from the body.~   "
134935|NCT01288729|"~     This is an open label cross over study looking to compare the length of infusion set wear~     using a teflon catheter or a steel catheter.~   "
134936|NCT01288716|"~     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the~     treatment of social withdrawal in subjects with autism spectrum disorders~   "
134939|NCT01288677|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of~     single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the~     drug is absorbed into the bloodstream, distributed in the body, and eliminated from the~     body.~   "
134940|NCT01288664|"~     This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release~     Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).~   "
134941|NCT01288651|"~     Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were~     previously shown to have a decreased six-minute walking distance. Therefore the~     investigators hypothesized that intravenous iron administration would improve exercise~     capacity in iron deficient IPAH patients.~      30 patients will be recruited for iron infusions. At baseline and after 12 weeks~     (endpoint)exercise test will be performed.~   "
134942|NCT01288638|"~     The purpose of our study is to evaluate the effectiveness of a lifestyle program for women~     with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a~     pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and~     aerobic exercise for improving PCOS disease features and risk factors for metabolic~     syndrome. We would like to determine the therapeutic effects of a lifestyle program that~     combines a pulse-based diet and exercise on the multiple disease measures of PCOS and~     metabolic syndrome.~   "
134943|NCT01288625|"~     The purpose of this study is to compare the incidence of stomatitis when treating with~     amifostine before radiation treatment.~   "
134944|NCT01288612|"~     The hypothesis of this study was that the comparative effectiveness of unsedated transnasal~     endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for~     BE.~   "
134945|NCT01288599|"~     Keyhole surgery for adnexal disease has traditionally been performed using three or four~     small incisions. The last years a new operating method has been introduced. This method~     makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and~     it might benefit the patient through less postoperative pain and a higher satisfaction with~     the cosmetic result. So far, many studies have shown that this new method is feasible for~     adnexal disease, but its superiority compared to conventional laparoscopy is to be proven.~     This study aims to show this difference.~      The investigators aim to compare experienced postoperative pain and use of analgesics in~     patients undergoing single port laparoscopy for benign adnexal disease with conventional~     laparoscopy. The investigators hypothesize that the patients will experience less~     postoperative pain and use less analgesic in the single port laparoscopy group.~      Further, the investigators aim to compare the satisfaction with the cosmetic results in the~     two groups. In addition, blood loss, operating time, complications and conversion to~     conventional laparoscopy will be registered in the two groups.~   "
134946|NCT01288586|"~     The purpose of this study is to examine the long term survivorship of the Scandinavian Total~     Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal~     rate of any component of the STAR ankle.~   "
134947|NCT01288573|"~     This is a multi-site study with plerixafor in pediatric cancer patients. The study will be~     conducted in 2 stages:~        -  Stage 1 is a dose-escalation study.~        -  Stage 2 is an open-label, randomized, comparative study using the appropriate dosing~          regimen identified in the Stage 1 dose-escalation study.~      All participating patients will receive a standard mobilization regimen as per study site~     practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating~     factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization~     regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage~     1 (dose escalation), and for those patients randomized to the plerixafor plus standard~     mobilization treatment arm in Stage 2 (randomized, comparative).~      Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.~   "
134948|NCT01288560|"~     Medical imaging is one of the fastest growing sectors in health care and increases in~     utilization underscore the need to ensure imaging technology is developed and used~     effectively. Evaluation of the clinical and economic impact of such imaging lags behind the~     technology development. Heart failure (HF)represents the final common pathway for most forms~     of heart disease and morbidity and mortality remain high. There is a need to identify~     imaging approaches that have a positive impact on therapy decisions, patient outcomes and~     costs. As well as standard methods to evaluate new and emerging techniques to better test~     their potential in a clinical management setting. The OVERALL OBJECTIVES of the IMAGE-HF~     trial are 1) to determine the impact of emerging imaging strategies, on relevant clinical~     outcomes and decision making in patients with HF; 2) to establish standardization quality~     assurance (QA) measures and central databases in order to achieve reliable outcome driven~     research; 3) to apply this as a platform for evaluation of new and emerging imaging~     biomarkers in HF.~      Project I-A: The PRIMARY OBJECTIVE OF AIMI-HF is to compare the effect of HF imaging~     strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac~     arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic~     heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the~     question(s) asked by the physicians (is there ischemia and/or viability), in agreement with~     their local practices for standard and alternative imaging.~      Secondary objectives of AIMI-HF To compare the effect of HF imaging strategies on~        1. The incidence of revascularization procedures (PCI, CABG)~        2. LV remodeling: LV volumes, LVEF~        3. HF symptoms, NYHA class~        4. QOL (MLHFQ, the EQ5D)~        5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)~        6. Health economics: Costs estimated through regression analysis and cost effectiveness~          assessed through decision modeling.~        7. The safety of imaging tests measured by cumulative radiation, adverse reactions to~          imaging contrast agents and stress testing agents will also be determined.~        8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g.~          PIIINP, OPN).~   "
134949|NCT01288547|"~     The purpose of this study was to measure potential mood, cognition and blood pressure~     effects of theobromine and caffeine in healthy women~   "
134950|NCT01288534|"~     The purpose of this study is to evaluate the safety and tolerability of using radiation~     therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation~     using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5~     radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical~     treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of~     radiation using a smaller number of treatments has been called hypofractionated radiation~     therapy.~      The Calypso is a new technique which uses beacons implanted into the prostate which using~     radio signals are able to localize and track the position of the prostate continuously~     during radiation therapy. The Calypso system has been approved by the United States Food and~     Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate~     cancer and is being utilized all across the United States. However, it has not been tested~     for hypofractionated radiation therapy.~   "
134951|NCT01288521|"~     Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation~     since immunosuppressive drug regimens consist of multiple medications with narrow~     therapeutic ranges and toxic adverse event profiles. Tacrolimus is a potent~     immunosuppressive agent utilized for rejection prophylaxis. Intensive pharmacokinetic~     monitoring must be performed following organ transplantation to ensure therapeutic drug~     concentrations due to its highly variable pharmacokinetics profile and narrow therapeutic~     index. Tacrolimus is a substrate for CYP450 3A and for the membrane transporter~     p-glycoprotein (Pgp). Polymorphisms in the gene encoding for CYP3A5 have been extensively~     studied and have been found to influence the dosing of tacrolimus. The effect of ABCB1 gene~     polymorphisms (which encodes for Pgp) upon tacrolimus pharmacokinetics has been more~     difficult to establish.~      This study will determine if haplotypes derived from three frequent polymorphisms in the~     ABCB1 gene (C1236T, G2677T, C3435T) can predict the degree of drug interaction between~     tacrolimus (CYP3A5/Pgp substrate) and ketoconazole (CYP3A5/Pgp inhibitor) in patients who~     are CYP3A5 nonexpressors.~      This prospective pharmacokinetic and pharmacogenomic study will enroll 20 stable renal~     transplant recipients with the CYP3A5 *3/*3 genotype and grouped by ABCB1 haplotype (CGC vs~     TTT). Pharmacokinetics of tacrolimus will be assessed on 2 occasions with and without~     ketoconazole coadministration separated by 1 week. The order of study occasions will be~     randomized in a crossover design.~      The results of this study may identify a genomic marker for predicting drug-drug~     interactions. Knowing this information a priori will aid clinicians in modifying drug dosing~     and alleviate patients of the burden of significant drug toxicities.~   "
134952|NCT01288508|"~     Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment~     of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of~     whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and~     Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a~     balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects~     of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention,~     hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy~     but also the palatability and tolerability of Supra Fiber in the treatment of chronic~     constipation.~      Aims:~        1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5~          grams BID) on the number of complete spontaneous bowel movements per week, and bowel~          symptoms.~        2. To examine the effects of fiber supplements on taste and quality of life in adults with~          functional chronic constipation in a randomized, double-blind, parallel group~          controlled trial.~      Methods: We propose to enroll 90 subjects with functional constipation in a single blinded,~     randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with~     Psyllium~      Data analysis: The primary outcome measure will be the global relief of constipation~     symptoms as rated by the subject at the end of each phase of the study. Additionally, we~     will assess several secondary outcome measures that will include the number of Complete~     Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile,~     patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and~     fullness and patient rating of constipation-related symptoms.~      Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of~     constipation compared to the baseline. This improvement will be comparable or superior to~     that achieved with psyllium treatment. Additionally, Supra Fiber will offer a natural, food~     based, convenient and more tasty alternative to over-the-counter laxatives and fiber~     supplements.~   "
134953|NCT01288495|"~     Data suggest that alanine may facilitate the intestinal absorption of fructose in patients~     with DFI and thereby may decrease GI symptoms.~      We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks~     that contain foods with free fructose or high fructose content will decrease GI symptoms in~     subjects with dietary fructose intolerance by facilitating intestinal absorption of~     fructose.~      Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or~     placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a~     randomized, double blind, cross over study.~      Methods: We propose to investigate the effects of co-administration of equi-molar doses of~     L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose~     intolerance, in a randomized, double blind, cross over study.~      Data Analysis: The primary outcome measure will be a comparison of baseline breath sample~     values and study visit breath sample values. Additionally, we will assess subject-reported~     occurence and severity of nine gastrointestinal symptoms during the test on a visual analog~     scale (VAS).~      Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will~     improve with ingestion of supplemental L-alanine (along with foods containing free fructose~     or high fructose content). We additionally expect treatment of DFI with administration of~     L-alanine powder to be more practical than co-ingestion of alanine-rich foods, and more~     convenient for patients.~   "
134954|NCT01288482|"~     Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to~     operate continuously with tidal breathing. As inhalation accounts for only about one-third~     of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the~     environment possibly posing a hazard any fellow-patients, family members, or health-care~     workers in the vicinity. The English-Wright has been the only American Thoracic Society~     (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the~     discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review~     the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further~     validate their performance.~      The investigators expect to show equivalence between the AeroEclipse II and the~     English-Wright nebulizers.~   "
134955|NCT01288469|"~     Primary Objective:~      To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein~     cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of~     atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59~     mmol/L) on atorvastatin 10 mg.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels in comparison with placebo,~          when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.~        -  To evaluate the efficacy of alirocumab when co-administered with a high dose of~          atorvastatin (80 mg) versus atorvastatin 10 mg.~        -  To evaluate the safety and tolerability of alirocumab when co-administered with 2~          different doses of atorvastatin.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics of alirocumab.~   "
134956|NCT01288456|"~     This will be an observational, prospective, non-randomized, pilot study to gain initial~     device experience on a novel space-occupying device in persons who are overweight or obese.~     No formal hypothesis testing will be conducted.~   "
134999|NCT01287884|"~     The primary objective of this study is to identify a correlation between the pH and pCO2 in~     arterial and venous blood. The secondary objectives include a correlation of pulse oximetry~     and arterial pO2 along with subgroup analyses of specific patient populations such as~     congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis,~     pneumonia, overdose, and trauma.~   "
134957|NCT01288443|"~     Primary Objective:~        -  To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein~          cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in~          participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin~          therapy.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment~          in comparison with placebo~        -  To evaluate the safety and tolerability of alirocumab~        -  To evaluate the development of anti-alirocumab antibodies~        -  To evaluate the pharmacokinetics of alirocumab~   "
134958|NCT01288430|"~     This phase 1 clinical trial is intended to understand the safety and tolerability of a new~     anticancer drug in subjects with advanced solid tumors. The patients who qualify for the~     study will receive a once daily dose of the drug taken by mouth and will undergo several~     tests to measure the drug in the blood and to understand the safety, tolerability and any~     effect of the drug on the tumor. The antitumor effect of the drug is not known in human.~   "
134959|NCT01288417|"~     The objective of this study is to evaluate the effect of boceprevir (steady state) on the~     pharmacokinetics of a single dose of raltegravir. The effect on the boceprevir~     pharmacokinetics of a single dose raltegravir will also be evaluated (compared to historical~     controls). Furthermore, the safety profile of the combination is studied.~   "
134960|NCT01288404|"~     Hypothesis: Subconjunctival bevacizumab injection may potentially suppress~     neovascularization in pterygium, preventing or retarding the progression of recurrence.~   "
134961|NCT01288391|"~     This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety~     and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses~     of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.~   "
134962|NCT01288378|"~     RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients~     with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for~     their cancer. It is not yet known whether caspofungin acetate is more effective when~     treatment starts after development of a fever or after the infection is shown in laboratory~     test, chest x-ray, or CT scan.~      PURPOSE: This randomized phase III trial is studying the best time to start caspofungin~     acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome~     that is newly diagnosed or in first relapse.~   "
134963|NCT01288365|"~     The purpose of this study is to determine whether exercise training will improve functional~     capacity in patients with heart failure and preserved ejection fraction.~   "
134964|NCT01288352|"~     EAST prospectively tests the hypothesis that an early, structured rhythm control therapy~     based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF)~     related complications in patients with AF when compared to usual care.~      Patients will be randomized to early therapy or usual care. In the early therapy group,~     patients will receive either catheter ablation (usually by pulmonary vein isolation), or~     adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be~     selected by the local investigator. Upon AF recurrence, both modalities will be combined.~      Usual care will be conducted following the 2010European Society of Cardiology ( ESC~     )guidelines for AF treatment. Early rhythm control therapy will be guided by~     Electrocardiogram (ECG) monitoring.~   "
134965|NCT01288339|"~     To estimate the progression free survival for subjects treated with panitumumab in~     combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin~     (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer~     with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and~     MMP-7 (Matrilysin) expression.~   "
134966|NCT01288326|"~     The study is conducted in Europe. The aim of this observational study is to assess glycaemic~     control while using liraglutide under normal clinical practice conditions in Belgium.~   "
134967|NCT01288313|"~     We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic~     acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating~     women~   "
134968|NCT01288300|"~     Main objective: To improve diabetes outcomes among Mexican-Americans with diabetes through~     church-based, culturally tailored, diabetes self-management interventions linked to the~     local healthcare system.~      Specific Aim: To pilot test a church-based, culturally tailored diabetes self-management~     intervention to improve diabetes outcomes among low-income Mexican-American with diabetes~      H1 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve glycosylated hemoglobin.~      H2 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve systolic blood pressure and low-density lipids.~      H3 A church-based diabetes self-care management curriculum partnered with the local~     healthcare system will improve diabetes related self-efficacy, self-empowerment and~     self-care management.~   "
134969|NCT01288287|"~     To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®)~     therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term~     clinical response at 18 months compared with a lack of clinical response at 12 weeks.~   "
134970|NCT01288274|"~     The purpose of this study was to demonstrate that with appropriate training, the provision~     of injectable contraceptives by community based reproductive health agents (CBRHAs) does not~     significantly differ from low-level clinic-based providers, or health extension workers~     (HEWs).~   "
134971|NCT01288261|"~     RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab~     may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and~     bavituximab together in treating patients with Human Epidermal growth factor Receptor 2~     (HER2 )-negative metastatic breast cancer~   "
134972|NCT01288248|"~     The purpose of this study is to determine whether the use of laryngeal mask classic as~     method for securing the airway in the population of 2 years to 14 years is associated with~     risk of laryngospasm as compared with the use of endotracheal tube.~   "
134973|NCT01288235|"~     Some patients with brain tumors receive standard radiation to help prevent tumor growth.~     Although standard radiation kills tumor cells, it can also damage normal tissue in the~     process and lead to more side effects. This research study is looking at a different form of~     radiation called proton radiotherapy which helps spare normal tissues while delivering~     radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal~     tissue then standard radiation. This therapy has been used in treatment of other cancers and~     information from those other research studies suggests that this therapy may help better~     target brain tumors then standard radiation.~   "
134974|NCT01288222|"~     Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and~     improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD)~     hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically,~     donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B~     haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect.~     This study proposes to prospectively test and validate the utility and effectiveness of~     further informing URD identification and selection by KIR genotyping as a supplement to HLA~     matching and the other variables known or suspected to indicate the best URD for a patient.~      Hypotheses:~        1. Favorable KIR donors will improve protection against relapse and improve leukemia free~          survival (LFS) after URD HCT for AML.~        2. Directed study procedures for rapid KIR genotyping and reporting to searching~          Transplant Centers (TC) can inform donor search and selection without delay in donor~          availability for HCT.~   "
134975|NCT01288209|"~     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination~     with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus~     (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy~     in Japan.~   "
134976|NCT01288196|"~     The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune~     responses of CNTO 6785 after administration to healthy adult volunteers.~   "
134977|NCT01288183|"~     The aim of this study is to determine whether a powerful technique of noninvasive brain~     stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking~     and constitute a treatment of tobacco addiction.~   "
134978|NCT01288170|"~     Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic~     Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly~     related to the respiratory affection which appears early in neonates.~      The constant improvement in symptomatic treatments and care strategies allowed CF patients'~     life expectancy to be increased over the last decades.~      Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18~     years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.~      Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is~     obtained by inhaled administration of tobramycin and is active against in vitro resistant~     Pseudomonas aeruginosa.~      Study hypotheses :~      Regarding literature data and in vitro studies, the administration of Nebcinal® 150mg/3ml~     administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of~     antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus®~     in children and adult patients with CF.~      Primary objective :~      To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by~     Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®~   "
134979|NCT01288157|"~     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male~     participants.~   "
134980|NCT01288144|"~     The investigators hypothesize that computer-assisted decision support will increase the~     percentage of women with a history of gestational diabetes who receive appropriate follow-up~     screening.~      Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among~     patients in the Partners Health Care system using administrative and laboratory data.~      Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to~     compliance regarding screening guidelines for women with a history of gestational diabetes.~      Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients~     with a GDM history and prompt screening will increase compliance with guidelines. The~     investigators hypothesize that decision support will significantly increase in the~     percentage of women screened.~   "
134981|NCT01288131|"~     Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve~     morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes~     immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The~     treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The~     investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell~     aplasia in this study.~   "
134982|NCT01288105|"~     The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management~     of patients with prior DES implantation who need major non-cardiac surgery and~     discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery~     until 30 days post surgery) incidence of major adverse cardiac events.~   "
134983|NCT01288092|"~     This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage~     design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in~     patients with progressive metastatic HR+ HER2- breast cancer who have received at least one~     prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic~     disease. Patients will be stratified into 3 groups according to their PI3K~     (phosphatidylinositol 3-Kinase) pathway activation status.~   "
134984|NCT01288079|"~     The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy~     in patients with major depressive disorder who exhibit inadequate response to~     antidepressants.~   "
134985|NCT01288066|"~     The clinical question on whether or not to replace the glenoid component in patients with a~     degenerative shoulder disease, has not been answered yet in a randomized study with enough~     statistical power. In this study, patients are randomly allocated to a treatment with a~     hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary~     objective is the comparison of pain and function between the treatment groups after 5 years~     using the Constant score.~   "
135544|NCT01280721|"~     ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of~     tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).~   "
134986|NCT01288053|"~     Allogeneic transplantation has been a high-risk procedure, although non-myeloablative~     conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The~     investigators, therefore, propose a phase I study of matched sibling allogeneic~     hematopoietic stem cell transplantation with non-myeloablative conditioning. In addition,~     graft versus host disease (GVHD) will be virtually eliminated by CAMPATH that removes donor~     T cells from the graft.~      The goal is to assess the toxicity/efficacy (phase I) of allogeneic non-myeloablative~     hematopoietic stem cell transplantation for high-risk Crohn's disease. In simplistic terms,~     this protocol is designed to ablate an aberrant immune system and then, similar to the use~     of marrow transplants for immunodeficient patients, reconstitute a new immune system with~     lymphocyte depleted marrow.~   "
134987|NCT01288040|"~     The purpose of this study is to determine whether split belt training can be used to treat~     walking pattern deficits from stroke and to determine whether different schedules and types~     of long term training on a custom split belt treadmill are likely to change/improve walking~     symmetry.~   "
134988|NCT01288027|"~     This is an open-label, multicenter study of participants with late-onset Pompe disease naive~     to treatment with enzyme replacement therapy (ERT). The primary objective of this study is~     to evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase~     alfa treatment in participants with Late-Onset Pompe disease.~      The secondary objectives are to characterize the disease burden in participants with~     late-onset Pompe disease and explore imaging, histologic, and functional assessments in~     these participants and to explore potential plasma or urine biomarkers relative to~     late-onset Pompe disease and participant's response to treatment with alglucosidase alfa~     (Myozyme®/Lumizyme®/GZ419829).~   "
134989|NCT01288014|"~     After immunization, particularly in older persons, some people are protected from disease by~     a vaccine and others are not. The investigators believe that this variable response may be~     due to overproduction of molecules that suppress development of immunity (antibodies and~     cell mediated immunity). Normally, these molecules are produced to make sure that immunity~     is regulated in just the right way for the body as a whole, and to prevent autoimmune~     disease.~      However, with aging, the immune system may have difficulty in proper immune regulation. Over~     production of immunosuppressive molecules after vaccination may interfere with the effects~     of a vaccine. For example when elderly individuals are immunized against zoster with a~     licensed vaccine, Zostavax, the vaccine is effective in only about 50 to 60%. The~     investigators will compare blood levels of antibodies, cellular immunity, and~     immunosuppressive molecules in recipients of Zostavax to see if there is a correlation~     between development low immunity and high levels of immunosuppressive molecules.~   "
134990|NCT01288001|"~     A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of~     one intra articular injection of sodium hyaluronate 2.0% in patients with painful~     osteoarthritis of the knee~   "
134991|NCT01287988|"~     The primary objective of this study is to assess visual function in up to 44 patients who~     have previously participated in either of the placebo controlled, ocriplasmin Phase III~     studies (TG-MV-006 or TG-MV-007).~   "
134992|NCT01287975|"~     This study is carried out to find out if Brain Computer Interface (BCI) technology or BCI~     technology coupled with robotic technology using a Haptic Knob will benefit patients with~     arm paralysis after stroke. BCI uses EEG-based motor imagery to detect user's thinking~     abilities which control motor movement. Haptic Knob is a novel robotic device, which~     specifically trains the wrist and hand with intensive repetitions in a supported~     environment.~   "
134993|NCT01287962|"~     Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase~     inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II~     clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated~     toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present~     phase III trial, the investigators will further evaluate the efficacy and toxicities of~     apatinib in the treatment of advanced non-squamous non-small cell lung cancer.~   "
134994|NCT01287949|"~     Primary objective:~        -  To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a~          0, 1 and 6-month schedule induce an acceptable immune response in terms of~          seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in~          subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster~          within the last 20 years~        -  To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of~          the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these~          subjects~      Secondary objectives:~        -  If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine~          containing Td-IPV valences induce an acceptable response in terms of seroprotection~          rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40~          years of age or older with no diphtheria- and tetanus-containing booster within the~          last 20 years~        -  To describe the immune responses to REPEVAX in these subjects~        -  To describe the immune responses to REVAXIS administered 1 and 6 months after the~          administration of REPEVAX in these subjects~   "
134995|NCT01287936|"~     The primary purpose of the clinical study is to determine the safety of a modified stem cell~     SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to~     determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke~     patients must be between 6 and 60 months after their stroke, and with only this one prior~     stroke, and and with no further improvement from physical therapy.~   "
134996|NCT01287923|"~     Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults.~     Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with~     patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between~     55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic~     biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such~     new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues~     or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor~     tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in~     a multicentric and prospective clinical trial. We hypothesized that blood may be a deep~     source of native and secreted analytes and therefore carries transcriptomic signatures~     related to DLBCL and its prognosis. Our project is organized in the extension of the~     GOELAMS-075 clinical trial which concerns aggressive DLBCL.~      Two complementary approaches will be followed, one at the transcriptomic level for~     confirmation of diagnostic biomarkers and to assess for predictive biomarkers. The other one~     concern biologic studies to validate our biomarkers at the tissue level. Our project will be~     organized around 4 workpackages (WP), each of them includes tasks with a specific schedule &~     predefined deliverables. The first one concerns the general management, data warehouse,~     collections and different administrative and preanalytic issues. The 3 other WPs are~     scientific. We are first going to validate a 30-gene list, candidate diagnostic biomarkers,~     by qRT-PCR on: *) an independent set of DLBCLs compared to matched healthy blood donors~     (sensitivity assessment) and, **) on a series of low tumor burden DLBCLs, mantle cell~     lymphomas and non-malignant inflammatory disease constituted by patients with a septic shock~     (specificity assessment). All this latter collections are already available and ready to~     use. Secondly, we will complete our series of 89 hybridized patients on AFFY WholeExon~     microarrays by 60 supplementary and available samples in order to assess for molecular~     predictor of patient outcome. This question will be address based on the 3-year and 5-year~     as well, EFS (Event Free Survivor). All the clinical data are available through the GOELAMS~     eCRF. Since we dispose of a 31 probesets, 30 single genes, signature for the DLBCL diagnosis~     that involves 9 genes related to the myeloid compartment including 6 genes involved directly~     or not to the Myeloid-Derived Cell Suppression (MDSC) process, 20 genes described in the~     context of the cancer and, 11 genes connected to endothelial cells, we decided to explore by~     flow cytometry blood circulating cells. We will look for myeloid populations &~     subpopulations, endothelial cells and microparticles. The goal is the identification of~     specific MDSC perturbations, angiogenic abnormalities and functional impacts on the immune~     response in the context of the cancer.~      We expect by our work to drive both basic science and clinical implications. On the~     scientific level, blood carries molecular and cellular components involved in tumor-host~     interactions. Our project should bring a deeper understanding in the immunological response~     that takes place in the blood compartment. This immunological response will be characterized~     on a molecular, cellular and functional level. On a clinical point of view, it may bring a~     new prognostic model in DLBCL. As blood is easily accessible, we expect it to be easily~     implemented in clinical practice and to allow the design of new clinical trials stratified~     on tumor biology features. It may also become a new way to monitor DLBCL's response to~     treatment. Furthermore, this project will provide a large amount of molecular data that can~     be easily connected with other ongoing GOELAMS studies. Valorisation of our findings will~     also be serious issue since our project is highly original and valuable.~   "
134997|NCT01287910|"~     The primary goal of this study is to better understand how Transmyocardial Laser~     Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina~     in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed~     Tomography (CT) images in some patients.~   "
134998|NCT01287897|"~     This is a proof of concept study to determine the efficacy and safety of a monoclonal~     antibody with three doses versus placebo. Subjects will be randomized to a treatment and the~     dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate~     to severe refractory Crohn's Disease.~   "
135996|NCT01274845|"~     The aim of the study: to assess the effect of short-term mechanical ventilation with heliox~     in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance~     and respiratory function parameters.~   "
135000|NCT01287871|"~     This study aims to 1) implement a culturally and contextually rooted innovative multifoci,~     social marketing intervention involving societal focused media campaign elements to break~     down the barriers and facilitate timely and appropriate screening practices for cervical~     cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and~     conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP~     test. Further, this is an international study that will bring together a multi-disciplinary~     investigatory team, community advocates and State health agencies to deliver a social~     marketing intervention in Southern California (the Inland Empire region specifically) and~     Trinidad and Tobago.~   "
135001|NCT01287858|"~     AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2~     hours after dosing) with approximately 240 mL of water either once daily or twice daily. It~     is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple~     oral doses of AC430.~   "
135002|NCT01287845|"~     PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of~     BAY1075553 in patients with prostate cancer and in healthy volunteers~   "
135003|NCT01287832|"~     There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia~     (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA~     bacteremia over the last 40 years. This has been largely attributed to isolates with~     increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was~     approved several years ago for the treatment of SAB and is being increasingly used for MRSA~     bacteremia due to isolates with increased MIC. Increased doses have been recommended for~     both of these drugs in the treatment of this infection without a trial demonstrating their~     relative efficacy or safety at higher doses. This study will randomize patients with SAB due~     to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin~     and daptomycin used at higher than traditional doses.~   "
135004|NCT01287819|"~     1. Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease~          (AD) and an important genetic factor for outcome of brain injury situations.~        2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain~          regional functions and brain network.~        3. Study about genetic contribution on fMRI is an emerging concept, which will help on~          understanding about how the genetics affecting the brain function.~   "
135005|NCT01287806|"~     The purpose of this study is to evaluate the efficacy and effect of ulinastatin in~     inhalation lung injury patients.~   "
135006|NCT01287793|"~     Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in~     QT/QTc intervals.~   "
135007|NCT01287780|"~     The majority of elderly patients with a displaced fracture of the proximal femur are now~     treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication,~     and the infection rate is high in this group of elderly patients. Local application of~     gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to~     determine whether locally administered collagen-gentamicin in the joint perioperatively in~     addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early~     postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal~     femoral fractures.~   "
135008|NCT01287767|"~     Dementia is one of the most common and devastating diseases in the elderly, it leads to~     helplessness, no cure exists and therefore care is necessary to provide. The care is~     associated with a great burden for the family carers and expensive for the society when~     residential care is required. The purpose of this study is to improve knowledge on how to~     provide better care for both the patients and their family carers, the investigators want to~     carry out a controlled trial using a rather cheap form of intervention, a multidimensional~     support program - an 18 months randomized controlled intervention study.~   "
135009|NCT01287754|"~     This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib)~     in patients with locally advanced or metastatic non-small cell lung cancer with epidermal~     growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg~     daily orally until disease progression or unacceptable toxicity occurs.~   "
135010|NCT01287741|"~     This open-label, randomized, parallel group study will evaluate the efficacy and safety of~     obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and~     prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP~     in previously untreated participants with cluster of differentiation 20 (CD20)-positive~     diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either~     obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375~     milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8~     cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab~     arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on~     study treatment is 24 weeks.~   "
135011|NCT01287728|"~     Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with~     symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant~     women. The high recurrence rate raises the long-term effectiveness of therapy. The~     hypothesis is the persistence of bacteria associated with vaginal flora imbalance as~     Atopobium vaginae and Gardnerella vaginalis. At the present time there is a lack of an~     accurate marker for the risk of recurrence.~   "
135012|NCT01287715|"~     The purpose of this study is to determine whether etanercept can be withdrawn successfully~     (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom~     disease remission is reached.~      Goals:~        1. to investigate in a randomized controlled trial:~             -  which proportion of JIA patients in remission can successfully discontinue~               etanercept compared to JIA patients in remission who continue etanercept;~             -  if time in remission on etanercept is an important factor in retaining remission~               after discontinuation of etanercept.~        2. to investigate in alle JIA patients who discontinue etanercept (including the control~          group):~             -  predicting factors (patient or disease characteristics, including time in~               remission, and MRP8/MRP14) for successfully discontinuation of etanercept;~             -  the disease course after discontinuation of etanercept (time to flare) and the~               effect of restarting etanercept after flaring.~   "
135013|NCT01287702|"~     The impact of feeding after endoscopic treatment of gastroesophageal varices has never been~     investigated. It is still unknown whether early feeding may increase early rebleeding in~     patients with acute esophageal variceal bleeding treated with EVL. It is customary for~     clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe~     approach to watch against early rebleeding. However, many patients would be fasting for a~     longer time and nutrition may be impaired, possibly resulting in aggravation of ascites.~     Thus, the investigators conduct a controlled study to evaluate whether early feeding have a~     bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric~     varices.~   "
135014|NCT01287689|"~     This non-interventional, epidemiological study assesses long-term outcomes in subjects~     receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen~     prescribed by the treating physician, under routine clinical conditions among at least 550~     subjects in Germany.~      Long-term outcome data are collected on patient characteristics in the various indications,~     drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns),~     effectiveness (i.e. number of infections), tolerability, health related quality of life, and~     economic variables (number of hospitalizations, sick-leave days etc.) with the possibility~     to estimate direct costs.~   "
135015|NCT01287663|"~     Homelessness, also name the fourth world, is a growing public health problem worldwide.~     Previous studies showed that up to 30% of the homeless people reported pruritus that often~     results in itchy lesions, which expose them to bacterial skin infections.~      The investigators therefore conducted a randomized, double-blind, placebo-controlled trial~     to test the hypothesis that a single oral dose of ivermectin was effective in significantly~     reducing the prevalence of pruritus in a sheltered homeless population.~   "
135016|NCT01287637|"~     The study is being conducted as a prospective randomized controlled multicenter study of~     patients with a temporary ileostomy due to rectal cancer. The study will be conducted in~     hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes~     Group (www.ssorg.net).~      The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead~     of later reversal more than 12 weeks after surgery.~   "
135017|NCT01287624|"~     This is a prospective, multi-center, open-labeled, randomized phase III clinical trial~     comparing overall response rate (ORR), progression free survival (PFS), overall survival~     (OS) and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine~     paclitaxel combination (GT).~   "
135018|NCT01287611|"~     Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology~     Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S~     (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in~     subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies,~     ...) are very important issues. Classically Kerr incision is repaired with continuous locked~     suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in~     turn may reduce short and long term complications. For this reason, the investigators aimed~     to compare two closure techniques.~   "
135019|NCT01287598|"~     -  To evaluate the effect of BAY73-4506 on the pharmacokinetics of probe substrates of CYP~          2C9 (warfarin), 2C19 (omeprazole) and 3A4 (midazolam) administered in a cocktail~          approach and on the pharmacokinetics of a probe substrate of CYP 2C8 (rosiglitazone)~        -  To evaluate safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of~          BAY73-4506 in patients with advanced solid tumors~   "
135020|NCT01287585|"~     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme~     versus placebo in patients with hepatocellular carcinoma who have failed prior systemic~     treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an~     amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the~     hepatocellular carcinoma cells will starve and die.~   "
135021|NCT01287572|"~     Pediatric patients admitted to the intensive care unit and requiring conscious sedation for~     minor surgical procedures are at risk to hypoventilate and retain CO2.~      The rise in CO2 levels is not well described and unpredicted. In this study the~     investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring~     System) a device recently approved for clinical use. The hypothesis is ventilation of~     patients undergoing conscious sedation is compromised and CO2 levels might rise~     significantly to levels that potentially can effect hemodynamics.~      In order to avoid hemodynamic changes proper and routine monitoring is recommended.~   "
135022|NCT01287559|"~     The investigators are studying a disease called necrotizing enterocolitis (or NEC for~     short), which affects premature infants. It is the most common surgical emergency involving~     neonates admitted to Newborn Intensive Care Units. Currently, clinicians are unable to~     identify which infants will go on to develop NEC before they become ill. Clinical signs of~     illness occur relatively late in the course of the condition, making NEC more difficult to~     treat. The investigators will test a new probe that uses safe levels of visible and infrared~     light, with and without ultrasound imaging, to see if the investigators can identify infants~     before they get sick using a simple, noninvasive test, This test will be repeated through at~     least one feeding (which stresses the gut) each day. If successful, the health benefit will~     be large, as it is estimated that treating NEC alone (not including treating its later~     complications) adds $650 million to the annual health bill.~   "
135023|NCT01287546|"~     The objective of this study is to determine a recommended Phase 2 dose range of LY2875358~     that may be safely administered to participants with advanced cancer. In Part A and Part A2~     of this study, escalating doses of LY2875358 as monotherapy and in combination with~     erlotinib will be evaluated for safety and tolerability, respectively. Part B is a~     dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous~     non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone~     metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma~     with liver metastases, and for LY2875358 in combination with trametinib in participants with~     uveal melanoma with liver metastases.~   "
135024|NCT01287533|"~     This study was to investigate the efficacy of oral monthly ibandronate in the management of~     glucocorticoid induced osteoporosis in women with rheumatoid arthritis.~   "
135997|NCT01274832|"~     The aim of this study is to investigate the impact of DBS not only no motor outcomes, but~     also on neuropsychological and psychiatric aspects and on quality of life in young patients~     with a short history of disease.~   "
135025|NCT01287520|"~     The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of~     LY2090314 in combination with pemetrexed and carboplatin in patients with~     advanced/metastatic cancer. Part A of this study will consist of dose escalation of the~     study regimen, and Part B will consist of an expanded cohort to confirm the dose provided~     from Part A.~   "
135026|NCT01287507|"~     The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin~     (LF) to very low birth weight infants reduces late onset sepsis and necrotising~     enterocolitis and the effect of LF on regulatory T cells.~   "
135027|NCT01287494|"~     Using a randomized controlled design, the investigators will examine whether the DCM is an~     effective treatment for patients with late life depression in urban China. Our specific aims~     are: (1) to determine whether the DCM intervention results in improved outcomes compared~     with CAU at both the provider (e.g., greater adherence to quality indicators) and patient~     levels (e.g., greater reduction in depressive symptoms); and (2) to compare DCM with CAU~     with regard to a range of outcomes in other pertinent domains, both at the provider (e.g.,~     improvements in knowledge/attitudes) and patient (e.g., functioning, satisfaction) levels.~     The study will take place in 16 primary care clinics (PCCs) randomly assigned to deliver~     either DCM or CAU (8 clinics each) to 320 patients (aged≥60 years) with major depression~     (20/clinic; n=160 in each treatment condition). In the DCM arm, PCPs will prescribe 16 weeks~     of antidepressant medication according to the TG protocol. CMs monitor the progress of~     treatment and side effects, educate patients/family, and facilitate communication between~     providers; psychiatrists will provide weekly group psychiatric consultation and CM~     supervision. Patients in both DCM and CAU arms will be assessed by clinical research~     coordinators at baseline, 4, 8, 12, 18, and 24 months. HDRS, MMSE, CAS, SF-12, Treatment~     Stigma and the Client Satisfaction Questionnaire will be used to assess patients' outcomes;~     and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.~   "
135028|NCT01287481|"~     This interventional, randomized controlled study seeks to test the effects of an innovative~     emotional exposure and processing treatment that targets stress resolution, by comparing it~     with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The~     investigators also will test proposed mediators of the intervention, including improved~     autonomic regulation, and explore which subgroups of patients benefit the most from each~     approach.~   "
135029|NCT01287468|"~     Over the past five years, a spectrum of studies has shown that the stromal cell populations~     surrounding or embedding cancer cells in a variety of different tumor types are~     intrinsically involved in the mechanisms affecting tumor growth and metastasis. Among these~     cells, fibroblasts and myeloid derived suppressor cells (MDSCs) have been shown to play key~     roles in the regulation of tumor cell behaviors, via differential gene expression,~     regulation and secretion of specific chemokines (e.g., RANTES, CXCL12 and CXCL14), cytokines~     (e.g., TNF-α, IL-1β, NF-κB) and control by inflammatory and immunomodulatory cells,~     molecules or potent growth factors. Of particular interest is that the various stromal~     immune cells (dendritic cells and T cells) and inflammatory MDSCs found in primary and~     metastatic tumors behave very differently from those present in normal or non-cancerous~     counterpart tissues. In light of these new understandings in cancer biology, the~     investigators believe that systematic and innovative approaches to further research are very~     much needed in Taiwan and at our Academy. Here the investigators propose to investigate the~     tumor suppressive effect of anti-inflammatory phytomedicines on regulation of stromal immune~     cells and fibroblasts in breast cancers. The investigators will employ the TS/A and 4T1~     mouse mammary carcinoma system to conduct an in vivo study of several specific candidate~     phytomedicines (cytopiloyne, Wedelia chinensis, shikonin, emodin and others that the~     investigators have already identified as conferring anti-inflammation related activities)~     for inhibition of TS/A and 4T1 tumor growth and specific effects on inflammation-associated,~     cellular and molecular functions of stromal immune cells, fibroblasts and MDSCs. When potent~     and specific anti-tumor effects are detected, the investigators will extend our study to a~     three-dimensional collagen/Matrigel culture system for ex-vivo study focusing on the stromal~     cell-mediated or -associated anti-tumor effects of TS/A or 4T1 cells, using the organoid~     tissue culture systems the investigators have previously developed in our laboratory (JNCI,~     1979; Cancer Res., 1981). The investigators will establish reconstituted TS/A or 4T1 tumor~     cells with the stromal immune cells in a co-cultivation system. When the investigators have~     achieved demonstrable success, the investigators will extend the mouse system to human~     breast cancers (including primary and metastatic tumors) by a close collaboration (which the~     investigators have already established) with Drs.~   "
135030|NCT01287455|"~     Research Title: The effect of vitamin D replacement on airway reactivity, allergy and~     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic~     children.~      Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an~     immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract~     and airway hyperreactivity.~      Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and~     inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic~     children.~      Design: Double blind placebo control prospective study comparing the effect of Vitamin D~     replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled~     breath condensate in asthmatic pediatric population with vitamin D deficiency.~      Participant selection: The study group will consist of pediatric patients (age 6-18 years)~     followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.~      Patients with mild-moderate asthma with low or insufficient vitamin D levels that are~     currently not receiving anti-inflammatory treatment will be recruited.~      Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving~     placebo).~      Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance~     preparation once weekly for 6 weeks between visit two and three.~      Three visits will be conducted. Each subject will undergo evaluation including a respiratory~     questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or~     2 and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC)~     (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1,~     3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled~     allergens will be performed (visit 2, 3).~      Primary end point: Airway reactivity as assessed by methacholine challenge test.~      Secondary outcome parameters: All other parameters are the secondary end points.~   "
135031|NCT01287442|"~     It is well established to assess the functionality of a filtering bleb by intraocular~     pressure (IOP), either as an absolute value or as a percent reduction, and by the need of~     additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a~     clinical score, e.g. the Wuerzburg bleb classification score (WBCS). The purpose of this~     study was to find out whether there is a correlation between clinical findings, in~     particular IOP and the WBCS.~      100 eyes within two years after trabeculectomy were included into the study. Using colour~     photographs the filtering bleb was evaluated according to the WBCS from two different~     examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb~     appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings~     like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical~     history were taken by another examiner.~        -  Trial with surgical intervention~   "
135032|NCT01287429|"~     Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED);~     discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma.~     The initial diagnostic work-out is often not very accurate in defining the etiology and the~     underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful~     real-time bedside diagnostic tool in the critical patient. The aim of this study was to~     evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US,~     performed by emergency physicians at the time of patient first presentation to the ED, in~     identifying cardiac causes of acute dyspnea.~   "
135033|NCT01287416|"~     Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST)~     gatekeeper training will be significantly more likely to have increased knowledge and~     preparedness to help people with suicidal ideation than participants who receive the~     resilience retreat.~      Secondary Hypotheses:~        1. Participants in ASIST gatekeeper training will not have higher levels of~          post-intervention distress or suicidal ideation compared to the resilience retreat.~        2. High levels of distress, grief, and alcohol abuse will significantly impact on the~          learning and retention of suicide intervention skills.~   "
135034|NCT01287403|"~     Cereal grains contain a wide variety of different phytochemicals which may play different~     roles in physiology. Their response in plasma and urine after a meal is poorly defined for~     most cereals. This study will investigate the plasma response and urinary excretion of~     cereal compounds after eating 6 different types of cereal preparation, with a focus on~     alkylresorcinols.~   "
135035|NCT01287390|"~     Severe acute and late dysphagia is now considered as a dose-limiting toxicity of~     radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of~     life. We propose to preserve swallowing function by:~        -  adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to~          per-treatment changes occurring in the tumor and surrounding organs and tissues;~        -  reducing the volumes of elective neck, that may result in significant decrease of~          severe acute and late dysphagia.~   "
135036|NCT01287377|"~     The primary purpose of this study is to test the feasibility of sending pre-cessation~     nicotine patches and to examine the effects associated with the pre-cessation treatment~     phase. Specifically, this study aims to:~        1. See if subjects will use pre-cessation nicotine patches.~        2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine~          patches.~        3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of~          cigarettes smoked per day.~        4. See if sending 2-weeks' worth of patches is helpful to the quitting process.~   "
135037|NCT01287364|"~     This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years~     or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a~     novel-patient administered assessment of treatment satisfaction with and preference of an~     Internasal Corticosteroid (INCS)~   "
135038|NCT01287351|"~     This study will compare the absolute and relative effectiveness and cost-effectiveness of~     asthma management in patients in the USA on inhaled corticosteroid (ICS) maintenance therapy~     as HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone~     propionate (FP) pMDI. .~   "
135039|NCT01287338|"~     The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms~     (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.~   "
135040|NCT01287325|"~     This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients~     with COPD and cough.~   "
135041|NCT01287312|"~     Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure.~     Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported~     with a good results ( 4 cases). There were no serious advers effects.~      The investigators want to use also TCA 50% for endoscopic repair in children with recurrent~     TEF.~   "
135042|NCT01287299|"~     The purpose of the study is to determine if a low glycemic load diet reduces the gain of~     body fat and insulin resistance during the last half of pregnancy in obese women.~   "
135043|NCT01287286|"~     The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could~     minimize the gastrointestinal symptom of cancer patients with chemotherapy.~   "
135044|NCT01287273|"~     Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately~     following thawing or after incubation for additional 24-72 hours. The two methods are~     routine in IVF laboratories. In this study the investigators would like to compare between~     these two methods in terms of implantation rate, pregnancy rate and delivery.~   "
135045|NCT01287260|"~     This is a clinical study evaluating the superiority in efficacy and assess safety and~     tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with~     BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who~     are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.~   "
135046|NCT01287247|"~     This is a prospective, observational trial evaluating the real world use of~     Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated~     with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical~     experience. The physician must have chosen to treat the patient with Xeomin®~     (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may~     choose to treat their subjects with up to 2 treatment cycles (approximately 6~     months/subject) of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based~     upon his/her clinical experience with botulinum toxin. According and dependent on clinical~     practice, the investigators expect that subjects will be seen by the investigator for an~     average of 3 visits (two treatment cycles).~   "
135047|NCT01287234|"~     The purpose of this study is to evaluate an external device (SonR sensor) that is capable of~     detecting sounds created by the heart (SonR signal). Based on the sounds created by the~     heart and recorded by the SonR sensor, optimal timing settings for the cardiac~     resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators~     will then compare the timing settings suggested by SonR to the settings suggested from the~     echocardiogram. The objective of this study is to determine if differences exist between~     these different methods of timing the contractions of the top and bottom chambers of the~     heart and if the SonR signal is able to produce results similar to those of an~     echocardiogram.~   "
135048|NCT01287221|"~     The purpose of this study was to determine whether Rifampicin was effective in slowing or~     reversing the progression of multiple system atrophy (MSA). Research studies indicate that~     there is an abnormality in protein synthesis and structure in parts of the brain responsible~     for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse~     this protein alteration. The study was done on participants with early MSA. The study~     consisted of taking the drug 2 times a day for 12 months. Participants underwent an~     evaluation of symptoms and function and will underwent a neurologic examination at the~     beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9~     months by telephone. Studies were done at 10 participating sites.~   "
135049|NCT01287208|"~     The main objective of this study is to test an intervention to increase the physical~     activity of medical residents, an employee population with little time for exercise.~     Specifically, the aims of this study are:~        1. To determine if providing medical residents with an activity device that measures~          steps, distance, and calories burned and tracks this information over time on a website~          increases residents' physical activity levels as measured by number of steps per day~          compared to a control group using a blinded activity device (no feedback).~        2. To determine if an unblinded team competition using the activity device directly~          following the randomized phase increases residents' activity level compared to~          baseline.~        3. To determine if activity level is associated with change in weight during the residency~          year.~        4. To determine if the average hours of sleep per week is associated with changes in~          weight and with activity level.~   "
135050|NCT01287195|"~     This study will assess the safety and efficacy of orally delivered short-term OKT3 in~     patients with active ulcerative colitis.~   "
135051|NCT01287182|"~     This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness~     in Assessing the Risk Factors of Atherosclerosis.~   "
135052|NCT01287169|"~     We intend to conduct a pilot study designed to measure BPA levels before and after~     occupational exposure to thermal paper used in cash registers. We will recruit cashiers from~     a local commercial store that is currently still using BPA-laden thermal paper and plans to~     switch to BPA-free paper in the near future. The study uses a within-subject comparison~     design, using serum and urine samples to determine whether BPA is detectable in the study~     population at sufficient levels to measure differences in paired samples. Two phases of~     sample collection are proposed: Phase I - collecting paired samples on two separate~     occasions before the implementation of BPA-free thermal paper use in cash registers; and~     Phase II - collecting paired samples on two separate occasions after the implementation of~     this change in thermal paper.~   "
135053|NCT01287156|"~     Background:~      - The Center for Neuroscience and Regenerative Medicine is working to improve physicians'~     understanding of brain injury. More information is needed on traumatic brain injury (TBI),~     especially how well a person recovers from TBI and how the brain changes over time in people~     with TBI. To conduct this research, the center is sponsoring a number of research studies on~     TBI and is interested in evaluating individuals with TBI or post-concussive syndrome to~     determine if they might be eligible for future studies.~      Objectives:~      - To develop a pool of individuals with traumatic brain injury and post-concussive syndrome~     for future research studies.~      Eligibility:~      - Individuals at least 18 years of age who have symptoms of or have been diagnosed with~     traumatic brain injury or post-concussive syndrome and are willing to participate in future~     studies.~      Design:~        -  Participants will be screened with an initial telephone interview, and will be asked to~          come to the National Institutes of Health for an in-person screening visit.~        -  At the screening visit, participants will provide a medical history, have a physical~          examination and an electrocardiogram, provide blood samples, and complete a study~          questionnaire on their TBI and its symptoms, including how the injury occurred, when it~          occurred, and any previous brain-related injuries.~        -  Participants will also provide contact information to enable researchers to contact~          them for future studies.~   "
135054|NCT01287143|"~     Background:~      - Fever is a common symptom of illness, but it can involve many signs (a signal that~     something is not right in the body that can be seen by others, such as vomiting) and~     symptoms (a signal that something is not right in the body that are felt only by the person,~     such as pain) that may differ depending on the type of illness involved. Researchers are~     interested in studying individuals who have a fever to examine how often these signs and~     symptoms are experienced by patients.~      Objectives:~      - To identify and evaluate the signs and symptoms of fever and examine their frequency in~     individuals who have fever.~      Eligibility:~      - Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a~     fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).~      Design:~        -  Participants will be screened upon admission to the NIH Clinical Center.~        -  Researchers will review the Clinical Center admission records.~        -  Participants will complete a 15- to 20-minute survey with questions about how they are~          feeling and what symptoms they have experienced before, during and after an episode of~          fever.~   "
135055|NCT01287130|"~     Background:~      - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell~     cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon,~     and rectum, also blocks signals that tell cancer cells to grow. Researchers are~     investigating the highest safe dose of AZD6244 to give with cetuximab, and will also~     investigate the effectiveness of this drug combination in individuals who have colorectal~     cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used~     to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective,~     but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab~     works, even in people with K-RAS tumors.~      Objectives:~        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for~          solid tumors that have not responded to standard treatment.~        -  To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for~          colorectal cancer that involves the K-RAS protein and has not responded to standard~          treatment.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that~          have not responded to standard treatment.~        -  Individuals at least 18 years of age who have been diagnosed with colorectal cancer~          that has not responded to standard treatment.~      Design:~        -  This protocol will involve two separate studies: an initial study to establish the~          highest safe and effective dose of AZD6244 and cetuximab in individuals with solid~          tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal~          cancer involving the K-RAS protein.~        -  Participants will be screened with a full medical history and physical examination,~          blood samples, imaging studies, and other tests as required by the researchers.~        -  AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an~          empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the~          first dose and over an hour for every following dose. This combination of daily AZD6244~          and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will~          keep a diary to record the time of taking AZD6244 each day, as well as any side~          effects.~        -  Participants will have frequent blood tests and other exams during the first cycle of~          treatment, up to five visits to the National Institutes of Health (NIH) and other~          visits to their local doctor to in the first 28-day cycle.~        -  During subsequent cycles, participants will have four visits to NIH and four visits to~          your local doctor for examinations, blood tests, and imaging studies.~        -  Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles,~          until the tumor grows, unacceptable side effects development, or the participant or~          participant's doctor decides to stop participation. There will be a final study visit~          that repeats the procedures performed during the screening visit....~   "
135056|NCT01287117|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite~     standard-dose H1 antihistamine treatment.~   "
135076|NCT01286857|"~     The aim of the investigation is to evaluate the function of two new device parts to be used~     in a NPWT system; an on-top suction device intended to transport exudate from the wound and~     a silicon cover film intended to fixate the wound filler and seal tight to the skin in order~     to keep a moist environment.~   "
135057|NCT01287104|"~     Background:~        -  Bone marrow stem cells, which are found in the bone marrow and blood stream, can be~          collected and transplanted to treat a variety of types of cancer in a process known as~          hematopoietic stem cell transplantation (HSCT). When stem cells are taken from one~          person, most commonly a sibling or a family member, and then given to another person,~          this is referred to as allogeneic HSCT. Allogeneic HSCT has proven to be an especially~          effective treatment for patients with some types of cancers of the blood (leukemia) and~          certain solid tumors. The transplanted stem cells travel to the patient's bone marrow~          and begin producing normal blood cells, and also attack patient s cancer cells.~        -  Because allogenic HSCT does not always prevent the cancer from returning, researchers~          are interested in determining whether another type of immune cell taken from the stem~          cell donor s white blood cells, called a natural killer (NK) cell, can be given in~          addition to the HSCT to help fight the tumor. In the laboratory, NK cells have been~          shown to kill tumor cells, but it is not yet know if this will occur when given to~          patients after HSCT.~      Objectives:~        -  To determine the safety, effectiveness, and immune system response of giving NK white~          blood cells to individuals who have received allogeneic HSCT.~        -  To identify possible side effects from the treatment.~      Eligibility:~        -  Donors: Stem cell donors whose blood matches one of the recipients on six out of six~          HLA (blood immune marker) types. The donor may not be the identical twin of a~          recipient.~        -  Recipients: Individuals between 4 and 35 years of age who have been diagnosed with~          pediatric solid tumors that have not responded to standard treatment, or individuals~          between 4 and 18 years of age who have been diagnosed with leukemia that has not~          responded to standard treatment.~        -  Other eligibility requirements which include a physical exam and blood laboratory~          evaluation are included to make sure it is safe for both the donor to donate and the~          recipient to undergo the transplant procedure.~      Design:~        -  Donors and recipients will be screened with a full medical history and physical~          examination, and will provide blood and urine samples; recipients will have tumor~          imaging studies and other tests as required by the researchers.~        -  Donors:~        -  Participants will receive filgrastim injections (to stimulate the bone marrow) for 1~          week to make stem cells travel from bone marrow to blood.~        -  Participants will provide stem cells and NK cells through apheresis.~        -  Recipients:~        -  Participants will have three cycles of chemotherapy to treat the underlying cancer and~          weaken the immune system so that it will accept the donor cells.~        -  Participants will then receive preparative chemotherapy for the transplant and two days~          after the last dose of chemotherapy, participants will have allogenic HSCT using the~          donated stem cells.~        -  Participants will receive an infusion of NK cells on days 7 and 35 after the HSCT. -~          Participants will remain in the hospital for monitoring after the HSCT and NK cell~          treatments, and will be followed closely as outpatients for the first 6 months after~          the transplant and then less frequently for at least 5 years.~   "
135058|NCT01287091|"~     This will be a single-center, open-label, 3 part study. The study is designed to determine~     the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting~     conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980~     tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the~     presence or absence of a high-fat meal.~   "
135059|NCT01287078|"~     Background:~      - Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that~     occurs as a complication of either lung transplantation or bone marrow/blood stem cell~     transplantation. In bronchiolitis obliterans, the body s white blood cells or white blood~     cells from the transplant attack the lungs, which leads to the destruction of lung tissue,~     and ultimately, scarring or fibrosis of the lung tissues. When a patient develops fibrosis~     of the lungs or bronchioles, the lungs no longer work properly, which causes difficulties~     with breathing that lead to a diminished quality of life and an increased risk of death.~     Treatment typically involves immunosuppressive therapy such as oral cyclosporine or steroid~     therapy, but these treatments are only marginally effective and can cause significant~     toxicities and increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher~     concentrations of cyclosporine in the lungs and lower concentrations of cyclosporine in the~     blood than oral cyclosporine. Therefore, it could have advantages over conventional oral~     immunosuppressive therapies used to treat this disorder. Researchers are interested in~     testing whether inhaled cyclosporine therapy could be used as a safe and effective treatment~     for bronchiolitis obliterans or bronchiolitis obliterans syndrome occurring after bone~     marrow/blood stem cell or lung transplants.~      Objectives:~      - To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and~     quality of life in individuals with bronchiolitis obliterans.~      Eligibility:~      - Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis~     obliterans or bronchiolitis obliterans syndrome after blood or lung transplants.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, lung function tests, imaging studies, and quality of~          life questionnaires.~        -  Participants will take cyclosporine inhalation solution through a nebulizer. The~          nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then~          breathed in through a mouthpiece. The process takes approximately 20 minutes. The~          solution will be provided in single-use vials.~        -  Participants will continue to take all medications for post-transplant care as required~          by their doctor and the study researchers. Attempts will be made to reduce the doses~          and types of immunosuppressants given to participants on the study, as long as the~          treatment continues to produce improved or stable lung function.~        -  Participants will have study visits every 3 weeks with blood and urine tests, lung~          function tests, and imaging studies. Participants will also complete quality of life~          questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed~          by a final follow-up visit 2 weeks after the end of the study.~        -  Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive~          further therapy with inhaled cyclosporine at the end of the study by participation in a~          separate study extension.~   "
135060|NCT01287065|"~     This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way~     crossover study in patients with persistent bronchial asthma to compare the effect of~     morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI)~     inhalation powder on lung function. Following screening there will be a run-in period of 14~     days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last~     for 14 days each with a 14-21 day washout period between starting the next. Key assessments~     include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital~     signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.~   "
135061|NCT01287052|"~     BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency~     rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous~     oxide has analgesic properties similar to those of opioids and is easy to administer. It has~     been shown in two small studies to be effective in treating migraine headaches.~      RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment~     of acute migraine headaches in children and adolescents presenting to an Emergency~     Department?~      DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be~     taken to examine change in pain scores before and after nitrous oxide treatment.~      METHODS Each participant will be given nitrous oxide until he/she reports a pain score of~     zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of~     0-10 before the treatment and after the treatment at multiple time-points.~   "
135062|NCT01287039|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in~     patients with eosinophilic asthma.~   "
135063|NCT01287026|"~     Background:~      - Currently, heart catheterization procedures are guided by X-rays. Researchers are~     developing new techniques to perform heart catheterization without the use of X-rays by~     investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses,~     researchers are interested in performing a part of the standard X-ray catheterization~     procedure using MRI on individuals who are scheduled to have heart catheterization.~      Objectives:~      - To examine the safety and feasibility of right-heart catheterization using MRI-guided~     catheters.~      Eligibility:~      - Individuals at least 21 years of age who are undergoing a medically necessary heart~     catheterization procedure.~      Design:~        -  The research MRI procedure will be performed either before or after standard X-ray~          guided heart catheterization.~        -  Participants will be transferred from an X-ray table onto an MRI table and advanced~          into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure~          blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed~          for approximately 30 minutes.~   "
135153|NCT01285843|"~     This is a monocentric, prospective, randomized clinical survey to verify if the~     periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component~     is equivalent.~   "
135064|NCT01287013|"~     Background:~      - Procedures that use medical tools in or near a possible abnormality in the body often use~     computed tomography (CT) scans to locate the abnormality and guide the path that a needle~     will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two~     new procedures being studied to help guide the needle. Xperguide is software that uses CT~     images to help the doctor choose the needle path. EM tracking uses special medical tools~     with miniature coils that act like a GPS device to show the location of the needle in the~     body. Xperguide and EM tracking have been used in humans and have good results, but they~     have not been compared with each other and regular CT to determine whether they are better~     than the standard approach.~      Objectives:~      - To compare the results of Xperguide, electromagnetic tracking, and regular computed~     tomography during a guided percutaneous procedure.~      Eligibility:~      - Individuals at least 18 years of age who are required to have a CT-guided percutaneous~     procedure.~      Design:~        -  Participants will be screened with a physical examination and medical history, and the~          results of any previous imaging studies will be examined before study enrollment.~        -  After a pilot phase, the study will involve two phases to compare the results of the~          different procedures. The first phase will involve comparing Xperguide to CT, and the~          second will involve comparing Xperguide to EM tracking.~        -  Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have~          Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have~          repeated procedures (like a biopsy before and after chemotherapy) will be randomized~          for the first procedure and the second procedure will be done using the other method.~        -  Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have~          Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have~          repeated procedures (like a biopsy before and after chemotherapy) will be randomized~          for the first procedure and the second procedure will be done using the other method.~        -  Standard post-procedure followup care will be given after the study procedure is~          completed.~   "
135065|NCT01287000|"~     Background:~        -  There has been little research on the long-term health effects from oil spills, even~          though at least 10 percent of all oil tanker spills between 1970 and 2009 have affected~          coastal populations. The Deepwater Horizon disaster, with its release of approximately~          5 million barrels (~680,000 tons) of crude oil into the Gulf of Mexico, is far larger~          than any of the individual tanker spills. Given the magnitude of this spill and the~          scope of the potential exposures, including the 55,000 workers involved in clean-up~          efforts and countless residents of the affected areas, researchers are interested in~          monitoring Gulf clean-up workers to understand the adverse consequences of oil spills~          in general.~        -  The Gulf Long-term Follow-up Study will investigate health effects associated with the~          clean-up activities following the Deepwater Horizon disaster in the Gulf of Mexico on~          April 20, 2010. More than 100,000 persons completed safety training in preparation for~          participation in clean-up activities related to the spill. Many of these individuals~          participated in active clean-up efforts, but others did not. Exposures among persons~          involved in clean-up range from negligible to potentially significant, especially for~          workers involved in tasks associated with direct exposure to crude or burning oil, or~          to chemical dispersants. However, prediction of adverse health effects is not possible~          because the long-term human health consequences of oil spills are largely unknown. In~          addition to the oil itself, the widespread economic and lifestyle disruption caused by~          the oil spill may contribute to mental health problems among this population.~      Objectives:~      - To investigate potential short- and long-term health effects associated with clean-up~     activities and exposures surrounding the Deepwater Horizon oil spill.~      Eligibility:~      - English-, Spanish-, and Vietnamese-speaking workers and volunteers at least 21 years of~     age engaged or potentially engaged in oil spill clean-up operations in the Gulf of Mexico,~     or who lived in affected areas (Louisiana, Mississippi, Alabama, and Florida coastal~     regions).~      Design:~        -  Participants will be divided into groups of those who performed oil-spill~          clean-up-related work ( exposed ) and those who did not engage in clean-up-related work~          ( unexposed controls).~        -  Participants will be screened with a full medical history and physical examination, as~          well as an interview to determine the nature of their potential exposure.~        -  Participants will provide blood, hair, toenail, urine, and saliva (spit) samples.~          Participants may also have a lung function exam.~        -  Participants will have researchers collect dust from their homes by using wipes and~          special vacuum bags.~        -  Participants will also provide detailed contact information, including their Social~          Security number, to be contacted in the future for long-term health follow-up~          appointments. These appointments will include 30-minute telephone interviews every 2~          years.~   "
135066|NCT01286987|"~     This is a single-arm, open-label study to assess the safety, pharmacokinetics,~     pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors~     with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation~     phase in which the maximum tolerated dose will be defined, and a dose expansion phase.~   "
135067|NCT01286974|"~     A pharmacokinetic study to access how the body absorbs and removes linifanib in male~     patients with advanced solid tumors.~   "
135068|NCT01286961|"~     As the duration of the interval between the time of last preparation-agent dose and the~     start of the colonoscopy is increasing, the quality of bowel preparation will be worse.~   "
135069|NCT01286948|"~     It has been proposed that levonorgestrel (LNG) in a vaginal gel could be used as an 'on~     demand' contraceptive when used before coitus. Levonorgestrel was selected as it is a~     component of many approved oral contraceptive pills and also it is the active agent in Plan~     B, an FDA-approved regimen for emergency contraception (EC). In previous studies it was~     demonstrated that an LNG vaginal gel was absorbed and was effective in preventing follicular~     rupture. The overall proportion of cycles with lack of follicular rupture within 5 days of~     LNG administration or with ovulatory dysfunction (follicle rupture preceded by an inadequate~     LH surge) was 96% for LNG gel and 39% in the inert gel cycles (control group).~   "
135070|NCT01286935|"~     The purpose of this study is to determine the long-term efficacy and safety of two doses of~     safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with~     idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable~     dose of levodopa.~   "
135071|NCT01286922|"~     The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare~     traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese~     men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3~     months of monitored exercise using a randomly assisgned design where participants will~     exercise under either AER or INT training conditions. The AER training condition will be~     consistent with standard-of-care recommendations. Exercise training will entail one~     3-month blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period,~     2) 1-month of traditional aerobic training and 3) 1-month of either continued AER or INT.~   "
135072|NCT01286909|"~     A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in~     Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).~   "
135073|NCT01286896|"~     The purpose of this prospective study is to determine the safety and feasibility of~     pharmacokinetically (PK) guided dosing of sunitinib in 30 patients.~      At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib~     and SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough~     levels (and toxicity) dose adjustments will be made.~   "
135074|NCT01286883|"~     The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A~     total of approximately 22 cc of blood will be drawn during various chemotherapy infusions.~     Additional proposed laboratory studies may unravel important biological insights into the~     relationship of circulating tumor cell genomic and genetic profiles as they compare to the~     primary tumors. Additionally the investigators hope to gain an understanding of potential~     subgroups of patients that have very high numbers of circulating tumor cells or those with~     early relapse of circulating tumor cells after early reduction of circulating tumor cell~     numbers.~   "
135075|NCT01286870|"~     While Core Becker patient follow-up is being completed this Continued Access Study is~     designed to enroll patients at a limited rate per month to allow for continued physician and~     patient experience with the device.~      Up to 12 patients per month at sites across the United States will be enrolled in this~     research study. These patients will be implanted with the Becker 25 or Becker 50~     Expander/Breast implant and monitored for 10 years for safety.~   "
135077|NCT01286844|"~     GSK2190915 is under development as an oral controller for the treatment of adult and~     pediatric asthma. This study is an open label, single and repeat dose escalation study, in~     children with asthma. It will investigate the pharmacokinetics of GSK2190915 in children,~     aged from 1 to 12 years old inclusive, to determine how the dosage regimen for GSK2190915 in~     a pediatric population should be adjusted to achieve approximately the same level of~     systemic exposure that is safe and effective in adults.~   "
135078|NCT01286831|"~     The purpose of this study is to characterise the metabolic disposition of radiolabelled~     GW642444 when administered orally.~   "
135079|NCT01286818|"~     The primary objective of this study is to investigate the safety and tolerability of the~     anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody~     Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil~     (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).~   "
135080|NCT01286805|"~     The purpose of this study is to determine whether the use of a lumbar plexus block for~     arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone~     in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce~     the total amount of pain medication needed, and therefore reduce the side effects of these~     medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar~     plexus block will significantly reduce patients' postoperative pain.~   "
135081|NCT01286779|"~     The purpose of this BAX 326 Continuation Study is to further investigate incremental~     recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related~     quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and~     moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326~     pediatric study 251101.~   "
135082|NCT01286766|"~     Number of patients planned The study adopted two parallel phase II studies, with the same P1~     and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of~     interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively.~     Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern,~     26 patients were required per arm to achieve the desired statistical power. Finally, taking~     a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.~   "
135083|NCT01286753|"~     This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib~     (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC)~     positive for the BRAF V600 mutation and resistant to radioactive iodine therapy.~     Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until~     progressive disease or unacceptable toxicity occurs.~   "
135084|NCT01286740|"~     The purpose of this Phase 2b study was to evaluate the efficacy and safety of the~     emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching~     from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at~     Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months~     prior to study start, were experiencing safety or tolerability concerns (in particular,~     EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.~   "
135085|NCT01286727|"~     The objective of the study is to evaluate the safety and activity of a investigational drug~     in improving renal function in patients who have undergone renal transplantation and have~     signs and symptoms of significant renal injury and are at risk for dialysis.~   "
135086|NCT01286714|"~     Anastomotic fistula following bariatric surgery are lifethreatening complication with a~     37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of~     complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and~     the severity of the fistula. The management of this complication is still controversial and~     potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The~     closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore~     endoscopic management has to be improved to reduce the duration of the treatment and the~     number of endoscopic sessions. OTSC clips could help to improve the endoscopic management~     because of a more prehensive, deeper and larger suture area.~   "
135087|NCT01286701|"~     The purpose of this study is to compare the rate and extent of absorption of terbinafine~     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg~     tablet under fed conditions.~   "
135088|NCT01286688|"~     The purpose of this study is to compare the rate and extent of absorption of terbinafine~     hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg~     tablet under fasting conditions.~   "
135089|NCT01286675|"~     Eltrombopag may improve the cell collection available for Autologous Stem Cell~     Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard~     ASCT will increase the number of blood cells collected and reduce the number of times blood~     needs to be collected. This study will also determine the highest dose of Eltrombopag that~     can be used without causing serious side effects.~   "
135090|NCT01286662|"~     The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome~     patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors.~   "
135091|NCT01286649|"~     The primary purpose of this study is to assess the safety of performing injections of human~     autologous hair follicle cells. The study will also measure the impact these injections will~     have on hair growth.~      20 patients will be selected for participation in this study (10 males and 10 females) based~     on their health status, current/past medications, and ability to adhere to protocol-related~     requirements. All patients will have evidence of mild to moderate androgenetic alopecia~     (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood~     (male) scales.~      At the first visit and after completing informed consent, patients provide a blood sample~     that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week~     before having a biopsy from the back of their scalp. The provided scalp biopsy is then~     processed to isolate hair follicle cells which are then replicated. Patients return to the~     clinic for injections of their own replicated cells (autologous cells) in medium (verum) and~     medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of~     the safety/tolerability of these injections will take place over the next 60 months both at~     in-clinic visits and telephone follow-up visits. At these visits patients will have their~     overall health assessed as subjective and objective assessments of the areas that were~     injected either with verum or control. During the first 24 months of follow-up, digital~     images will be taken of the scalp and of the two treatment areas injected with either verum~     or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2~     female) at each time point will provide biopsies of the injection sites for~     histopathological analysis. At the 60 month time point, any patients not previously~     providing biopsies for histopathological analysis will provide biopsies. Total duration of~     patient participation is approximately 63 months.~   "
135092|NCT01286636|"~     The investigators have developed a simple, accurate, and a point-of-care, computer-based~     clinical decision support system (CDSS) not only to detect the presence of sleep apnea but~     also to predict its severity. The CDSS is based on deploying an artificial neural network~     (ANN) derived from anthropomorphic and clinical characteristics.~      The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be~     diagnosed with the use of ANN without undergoing a sleep study, and that empiric management~     with auto-CPAP has similar outcomes to those who undergo a formal sleep study.~   "
135093|NCT01286623|"~     The treatment of HIV and the tests performed for HIV care have changed over the last 20~     years. However, improvement of management of HIV-infected subjects is still warranted,~     especially as the HIV-infected population is aging. Therefore, this study will involve the~     collection and analysis of clinical information obtained from subjects who are over 50 years~     of age. For example, patients' risk of heart disease will be measured and monitored by~     looking at blood tests and clinical data (such as blood pressure). This will allow~     researchers to understand if the current way of assessing the risk of future heart disease~     is the best one available for HIV-infected individuals. No genetic research will be done.~   "
135094|NCT01286610|"~     Vibration therapy is used for different indications in rehabilitation and sports medicine.~     So far, vibration therapy has not been investigated within the ICU setting. The~     investigators created this setting to show safety and applicability of vibration therapy in~     ICU patients. 30 patients will be stimulated by vibration therapy on two separate days~     during their ICU stay. Three collectives of equal size will be observed: One with patients~     on mechanical ventilation without signs of infection or suspected intracranial pressure~     problems, a second one with patients on mechanical ventilation in addition to signs of~     systemic inflammation but absence of suspected intracranial pressure problems, and a third~     one with patients on mechanical ventilation, signs of systemic inflammation in addition to~     presence of controlled intracranial pressure problems. Typical parameters of hemodynamic~     status, intracranial pressure and energy metabolism will be recorded for a defined period of~     time before, during and after vibration therapy itself. Vibration therapy will be combined~     with protocol based physiotherapy.~      Our aim is to show the effects of vibration therapy in ICU patients and its safe~     applicability.~      ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp~     and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will~     perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will~     perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg,~     randomized chosen. Measuring the local skeletal muscle metabolism will be done by~     microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration~     therapy combined with electrical muscle stimulation.~   "
135095|NCT01286597|"~     Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which~     the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of~     lactase.Individuals with LD may be intolerant of lactose in the diet and experience~     abdominal cramps, bloating and diarrhea; however the response is variable.Some tolerate~     moderate amounts of lactose without adverse effect,whereas others experience severe symptoms~     in response to even small doses. These problems may be representative of wider issues~     regarding individual tolerance to diet containing ubiquitous poorly absorbed, fermentable~     carbohydrates (such as: fructose, fructans)and be relevant to symptom generated in patients~     with diarrhea predominant irritable bowel syndrome (D-IBS).~      This project will investigate the effects of diet,lifestyle stress and psychiatric dietary~     on the development of functional gastrointestinal symptoms. Lactose will be used to assess~     tolerance to dietary challenge, a test that is particularly relevant in a Chinese population~     with a high prevalence of lactase deficiency.~   "
135096|NCT01286584|"~     The aim of this study is to assess the efficacy of varenicline compared to placebo in~     tobacco dependent individuals who are undergoing concurrent treatment for alcohol~     dependence. As they will be inpatients and under 24 hour medical care for the first 21 days~     of treatment, or receiving outpatient treatment through the Alcohol Research and Treatment~     Clinic, this will allow for a comprehensive assessment of the safety of varenicline in this~     population with minimal risk of adverse consequences. The patients will continue their~     cessation treatment for an additional 10 weeks as outpatients through the Nicotine~     Dependence Clinic at CAMH. They will also be contacted at 6 months for follow-up.~   "
135097|NCT01286571|"~     The objective of this study is to investigate the effect of food on the relative~     bioavailability of a 50 mg BI 135585 XX tablet.~   "
135098|NCT01286558|"~     Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug~     alone, often a combination of two or more drugs is essential to achieve a sufficient~     antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009~     combination therapy is recommended. In JSH 2009 it is advised to start the combination~     therapy at a low dose, and to increase the dosage when the antihypertensive effect is not~     sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg~     fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not~     control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control~     their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is~     recommended.~      In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood~     pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination~     was shown (U07-3503-02). But the sponsor has no data that verifies this difference in~     Japanese patients.~      Thus, this clinical trial is being conducted to investigate the antihypertensive effect and~     safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients~     with essential hypertension. In this trial, a multi-centre, randomised, double-blind,~     double-dummy, active-controlled, parallel group comparison method is employed.~   "
135200|NCT01285232|"~     Rationale: Once diabetes develops, β-cell function progressively deteriorates and~     therapeutic approaches that prevent of delay loss of β-cell function are needed in the~     treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may~     be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.~      Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra)~     improves beta-cell function in subjects with β-cell dysfunction.~   "
135099|NCT01286545|"~     Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with~     ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because~     patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients~     almost always leads to a disease relapse. Furthermore it is still unclear whether long term~     anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who~     participated in the EASIC and the DIKAS trial respectively who were treated with infliximab~     within these studies for 7 and 10 years respectively are followed up by using clinical~     outcome parameters every 6 months assessing efficacy and safety of long term treatment.~     Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is~     hypothesized that anti-TNF treatment with infliximab is effective and safe over a time~     period of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit~     radiographic progression of the spine.~   "
135100|NCT01286532|"~     This is a six-month non-interventional prospective study of various controller therapies in~     children with asthma in outpatient clinical practice.~   "
135101|NCT01286519|"~     The purpose of this study is to measure the level of medicines found in body fluids such as~     blood, urine, spinal fluid of children.~   "
135102|NCT01286506|"~     Dialysis is used to control the fluid balance and metabolic state of patients with kidney~     disease. Control of the metabolic state, via electrolytes, can be monitored using labs that~     are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid~     removal is much more difficult. This study aims to determine whether changes in the blood~     pressure associated with breathing correlate with or predict intolerance to fluid~     responsiveness with continuous dialysis.~      We hypothesize that a measurement of changes in blood pressure with breathing called~     arterial pulse pressure variation may be able to predict the ability to remove fluid during~     continuous renal replacement therapy.~   "
135103|NCT01286493|"~     Booster rabies vaccination in HIV - infected patients who have ever received rabies primary~     vaccination could improve their immune response to this kind of vaccine.~   "
135104|NCT01286480|"~     The objective of this study is to evaluate the potential role of a cardiology clinic-based~     educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and~     their parents, and to determine whether this intervention results in improved~     self-management skills (e.g., renewing medication prescriptions), teens having greater~     knowledge of their heart condition, and more teen and parent satisfaction with services. The~     results of this study will form the basis for a website that in turn may serve as an~     additional means of providing transition interventions. The results of this study may also~     be applicable to youth with other special health care needs.~   "
135105|NCT01286467|"~     This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway~     on select solid tumors.~   "
135106|NCT01286454|"~     This Is A Study Of Bioavailability And Food Effect For Fesoterodine.~   "
135107|NCT01286441|"~     Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal,~     antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian~     Sandalwood oil to be promising as a treatment for common warts in adults and children.~      The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and~     30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo~     administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca~     vulgaris).~   "
135108|NCT01286428|"~     This study was designed in two phases: Phase I is designed to confirm that the surgeon is~     able to perform accurate liver surface registration including standard liver features used~     as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level~     of comfort with the procedure.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained,~     the registration points obtained during this procedure will be evaluated by the surgeon by~     moving the tracked laparoscopic probe over the liver surface and evaluating the location of~     the tracked laparoscopic probe displayed on the guidance system three dimensional (3D)~     image. The surgeon will accept or reject the registration accuracy.~      The hypothesis is that the surgeon will be able to successfully acquire liver surface~     registrations with a small learning curve for technique and will be able to proceed to Phase~     II of the study.~      Phase II contains the registration process included above but adds the additional process of~     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder~     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked~     and displayed on the Pathfinder three dimensional (3D) image.~      The surgeon will use ultrasound (US) guidance to locate tumor location during the~     laparoscopic procedure. The images collected during this process will be recorded by~     Pathfinder.~   "
135109|NCT01286415|"~     The purpose of this study is to compare group-administered Cognitive Processing~     Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress~     disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results~     of CPT exceed those of receiving a therapy that focuses on current problems rather than past~     trauma in a group format.~   "
135110|NCT01286402|"~     This study is designed to gather preliminary effectiveness and safety data on the use of~     bupropion for smoking cessation in pregnant women attending a community prenatal clinic.~     This study will provide critical preliminary data in preparation for a larger, Phase III~     clinical trial.~   "
135154|NCT01285830|"~     An altered microbial exposure may be partly responsible for the increase of allergic~     diseases in populations with a western lifestyle. Activation of the immune system by~     microbes early in life is probably required for an accurate maturation of the immune system.~     Probiotics, live bacteria which are considered to confer health when ingested, have been~     suggested to prevent eczema and sensitisation infants.~      The aim of this study is to assess the effect of oral supplementation with the probiotic~     bacterium Lactobacillus reuteri in infancy on the development of allergic disease and~     sensitisation during the first 2 years of life and to examine mechanisms possibly underlying~     eventual effects on allergic manifestations.~      A follow up was performed at 7 years of age.~   "
135511|NCT01281163|"~     This phase I trial studies the side effects and the best dose of lapatinib ditosylate and~     Akt inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate~     and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
135111|NCT01286389|"~     Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity~     and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the~     elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We~     hypothesized that promotion of weight loss in obese people with MCI, through caloric~     restriction could lead to improvement in cognitive performance or reduction in the rate of~     decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with~     MCI, will be randomized to two groups that will be followed for 12 months. The control group~     will receive conventional medical care. The intervention group will receive nutritional~     counseling individually and in groups, aiming to promote weight loss through caloric~     restriction, and medical monitoring. Before and after intervention patients will be~     evaluated for anthropometry, body composition, physical performance, control of~     comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin,~     interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E,~     neuropsychological battery, questionnaires about activities of daily living, physical~     activity and diet.~   "
135112|NCT01286376|"~     Determine the effectiveness of symbiotic LACTOFOS containing FOS and probiotics against~     placebo in patients with a diagnosis of constipation, comparing the average number of weekly~     evacuations in 2 (two) groups for 30 days.~   "
135113|NCT01286363|"~     The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of~     occlusal contact area and bite force of individuals with different craniofacial patterns~   "
135114|NCT01286350|"~     The purpose of this study is to see if a behavioral intervention for adolescents with type 1~     diabetes will improve adherence to T1D self-management activities and improve diabetes~     outcomes. We expect the intervention to improve diabetes outcomes when compared to usual~     care.~   "
135115|NCT01286337|"~     lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we~     hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph~     collection compared to the traditional surgical technique~   "
135116|NCT01286324|"~     The purpose of this study is to determine if an herb called chamomile can help to treat~     insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of~     time that you sleep and/or improving the quality of your sleep. The study will also be~     looking at the effect of chamomile on day time fatigue and functioning.~   "
135117|NCT01286311|"~     The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular~     disease quality improvement system that couples EMR-based patient identification with~     individually tailored patient messages. The study will test the hypothesis that that a~     tailored patient-directed approach to cardiovascular risk reduction integrated into~     patients' primary care delivery site will improve control of elevated low-density~     lipoprotein cholesterol and other card iac risk factors more than routine care alone for~     patients at intermediate or high risk for cardiovascular disease.~   "
135118|NCT01286298|"~     Gingival enlargement is one of the most common soft tissue problems associated with fixed~     orthodontic treatment. The presence of orthodontic appliances impedes oral hygiene measures~     and alters the oral microbial ecosystem to a more pathogenic oral biofilm. Subsequent~     accumulation of plaque can contribute to development of chronic periodontal inflammation and~     can progress to gingival enlargement. Gingival enlargement inhibits hygiene measures, slows~     down orthodontic tooth movement and cause aesthetic and functional problems. Management of~     gingival enlargement by non-surgical periodontal treatment is considered to be most~     important and effective. Optimal plaque control can be maintained by meticulous brushing,~     flossing and professional scaling. However, motivation of maintaining oral hygiene can be~     disappointing in some patients. In cases that the enlarged gingivae became fibrous, surgical~     treatment can be considered.~      Traditionally, gingivectomy was performed using scalpel under local infiltration. Since the~     first laser designed for dental use was introduced in 1989. Laser technology has~     continuously developed over the years and there are now many different types of dental~     lasers using a variety of wavelengths, e.g. Diode, Er:YAG, CO2 and Er,Cr:YSGG lasers. In~     orthodontics, various intraoral soft tissues surgical procedures may be required frequently,~     e.g. gingivectomy, gingivoplasty, fraenectomy, exposure of unerupted/ impacted/ partially~     erupted teeth. The use of laser has becoming more popular because the advantages of laser~     therapy are good haemostasis, excellent visualization of the operating field, fewer intra-~     and post-operative complications, bactericidal effect, no suture required, less scars, and~     better pain control with effects of reduced use of local anaesthesia and analgesic. Diode~     laser unit has the merits of compact size and relatively low price. Gingivectomy by diode~     laser may become an effective adjunctive treatment in orthodontic practice.~      The aim of this study was to evaluate the clinical effectiveness of diode laser in the~     management of gingival enlargement related to orthodontic treatment.~   "
135119|NCT01286285|"~     The purpose of the study is to assess the number of severe, laboratory-confirmed influenza~     in children hospitalized to paediatric intensive care units. Furthermore, the proportion of~     these children from all children hospitalized to paediatric intensive care units with acute~     respiratory infections will be established.~   "
135120|NCT01286272|"~     This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride~     with or without bortezomib works in treating patients with untreated follicular non-Hodgkin~     lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different~     ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It~     is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with~     bortezomib in treating patients with follicular non-Hodgkin lymphoma.~   "
135121|NCT01286259|"~     The purpose of this study is to determine whether a two-week course of disulfiram will~     reduce the HIV-1 latent reservoir in patients on highly active antiretroviral therapy~     (HAART).~   "
135155|NCT01285817|"~     To establish the anti-tumour effect of this metronomic combination regimen defined by~     progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of~     treatment, as well as response rate after any number of cycles of treatment (best~     response).~      To define the safety profile of the combination. To characterize pharmacodynamics of the~     drug combination with the use of angiogenic markers (CEP, CEC, microparticles).~   "
135156|NCT01285804|"~     The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube~     (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or~     adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will~     eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease~     the oxygen concentration in the oropharynx.~   "
135122|NCT01286246|"~     Prematurity remains the most important single factor in perinatal morbidity and mortality.~     Unfortunately, the rate of premature delivery is increasing in Canada and is especially high~     in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of~     research into the causes of spontaneous preterm labor, few effective treatments have been~     identified. Progesterone is one candidate treatment. The purpose of this study is to~     investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm~     labor.~      Pregnant women who have symptoms of premature labor will be invited to take part in the~     study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they~     will be randomly allocated to either take progesterone 200mg each day via the vagina until~     36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know~     which group they are in.~      Women and their babies will be followed until 28 days after the birth, to find out about the~     length of the pregnancy, any adverse events that might occur (none have been reported in~     previous trials), and to look at whether women have taken the treatment.~      When the study is complete, the results for the progesterone group will be compared to the~     placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then~     this will be a possible treatment to help mothers in the future.~   "
135123|NCT01286233|"~     RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     fatigue.~      PURPOSE: This research study is studying biomarkers associated with fatigue in patients with~     early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.~   "
135124|NCT01286220|"~     The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths~     decreases disease severity in patients with moderate to severe atopic dermatitis.~   "
135125|NCT01286207|"~     This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949);~     MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the~     long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and~     migraine recurrence.~   "
135126|NCT01286194|"~     This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where~     the principal investigator will be a pharmacist.~   "
135127|NCT01286181|"~     Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as~     many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided~     breathing is a behavioral intervention that guides respiratory rates into a therapeutic~     range; prolongation of the expiratory phase improves hyperinflation, the most significant~     driver of dyspnea in this population. Device-guided breathing, has no known side-effects,~     and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.~   "
135128|NCT01286168|"~     Surgical site infection (SSI) after breast and axillary surgery occurs more often than for~     other clean surgical procedures. Infection in the setting of a tissue expander can be~     devastating and can lead to early implant loss and failed reconstruction. Surgical drains~     have been noted as a potential source for surgical site infections. Hypothesis: Bacteria~     present in surgical drains after tissue expander reconstruction may be decreased by simple~     and inexpensive local antiseptic interventions.~   "
135129|NCT01286155|"~     To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's~     esophagus (BE) in the community.~      To develop a population based clinical risk factor prediction model for the diagnosis of BE~     and identify novel risk factors for BE which would make population based screening more~     efficient. This will be an important first step in identifying the target population for BE~     screening, another crucial component of making screening feasible and efficient~   "
135130|NCT01286142|"~     In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A~     (H1N1). Although little is known about the pandemic influenza strain in children, during~     previous pandemics and influenza seasons children less than one year of age were shown to be~     at higher risk of influenza complications than older children. In light of the 2009 H1N1~     pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency~     (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat~     and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use~     in infants will dramatically increase due to the new authorizations for use in this~     population and high prevalence of H1N1 influenza circulating in the population. Ongoing~     safety surveillance is critical and this study will provide further data for evaluating the~     risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of~     both seasonal and pandemic influenza viruses circulating in the population. The study will~     also provide useful information on the dose and duration of treatment used in clinical~     practice and their relationship to adverse events.~   "
135131|NCT01286129|"~     Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of~     rhinitis, and multiple challenges may more adequately approximate natural exposure.~      Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory~     parameters in rhinitics with or without asthma.~   "
135132|NCT01286116|"~     The primary objective is to assess the safety of the CardioKinetix Parachute Implant and~     Delivery System in the partitioning of the left ventricle in patients with heart failure due~     to ischemic heart disease.~   "
135133|NCT01286103|"~     The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in~     the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing~     regimen in healthy adult volunteers~   "
135134|NCT01286090|"~     The purpose of this study is to assess the effectiveness of cisapride at improving symptoms~     associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.~   "
135135|NCT01286077|"~     The purpose of this study is to assess the effect of bortezomib on myeloma-related bone~     disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who~     have received high dose chemotherapy and autologous stem cell transplantation for primary~     treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study~     treatment assigned by chance like flipping a coin) to either bortezomib or observation~     alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4~     cycles. All subjects will be followed for a total of 24 months after randomization.~   "
135136|NCT01286064|"~     The aim of the present prospective study was to investigate the fluorescence emission of~     human blood plasma of patients with colorectal cancer.~      For years, serum tumor markers have been studied for the diagnosis and follow-up of~     colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising~     results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated~     CEA levels also occur in patients with benign disease, as well as in patients with other~     carcinomas. Nevertheless, surveillance programs are often based on the CEA test and~     combination with other markers is at present a matter of research. Alternative methods based~     on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of~     cancer. Few studies have been reported on the application of native fluorescence~     spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings~     prompted us to investigate the fluorescence emission of human blood plasma of patients with~     colorectal cancer. For this purpose, the blood of patients was collected and the~     fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that~     the fluorescence spectra were mainly characterized by the presence of an emission peaking at~     620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of~     405 nm was selected for the study. The fluorescence emission spectra were recorded in the~     range of 430-700 nm.~   "
135137|NCT01286051|"~     Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments~     of infertility. One common problem encountered while attempting OI using gonadotropins is~     premature ovulation. The purpose of this study is to examine the effect of a single~     injection of a medication, called ganirelix, to prevent premature ovulation. Patients will~     be divided into two groups. In the first group, gonadotropins will be used to stimulate the~     ovaries. In the second group gonadotropins will be used in addition to a single injection of~     ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be~     compared between groups.~   "
135138|NCT01286038|"~     The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people~     who have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are~     resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S.~     Food and Drug Administration [FDA] which can improve platelet counts). The investigators~     (the study doctor, study staff, and sponsor) want to find out what effects, good or bad,~     eltrombopag (study drug) may have on people with low platelet counts due to MDS. The~     investigators will also be testing how well eltrombopag may work at different doses in these~     diseases.~   "
135139|NCT01286025|"~     This study is designed to examine how the type of learning case affects the thinking of~     medical students in tutorial~   "
135140|NCT01286012|"~     The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing~     the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb)~     levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects~     who receive conventional dialysate without iron.~   "
135141|NCT01285999|"~     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™~     Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China~     with a single de novo atherosclerotic coronary artery lesion.~   "
135142|NCT01285986|"~     Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to~     PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia~     with respect to primary patency, secondary patency, and limb salvage~   "
135143|NCT01285973|"~     The aim of this prospective study is to assess the utility of treatment of leg ulcers using~     a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous~     oxygen pressure in the distal region of the wound.~      This is a multi-centre study on 60 patients who have a lower limb ulcer.~   "
135144|NCT01285960|"~     The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF~     V2 System when treating symptomatic uterine fibroids.~      The ExAblate System is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each~     sonication is used to heat small spots in the fibroid much like a magnifying glass can be~     used to focus light to heat a spot. The heat created kills a portion of the fibroid with the~     goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are~     performed until the entire fibroid is treated or the treated volume is determined to be~     appropriate.~      The ExAblate system is commercially approved in the United States to treat symptomatic~     uterine fibroids.~      The ExAblate UF V2 System is an experimental device and is being investigated in this study.~     While similar to the commercial system, the ExAblate UF V2 device includes the following~     major changes, among others, which are intended to improve device performance and safety:~        -  Up and down movement of the ultrasound transducer, in an attempt to improve fibroid~          treatment by moving the ultrasound focal point within the targeted fibroid.~        -  Ultrasound energy can be turned off for a specific area in an attempt to minimize~          amount of energy passing through sensitive areas of the body.~   "
135145|NCT01285947|"~     The purpose of this study is to compare the pain experience of patients who have not had~     dermatologic procedures (previously unexposed) using energy devices (lasers,~     radiofrequency, ultrasound, etc.) with patients who have previously had procedures~     (previously exposed) using energy devices. Based on previous clinical encounters,~     individuals with no prior experience with cosmetic procedures appear to experience more~     pain. However, no study to date has thoroughly examined this observation. As a result, this~     study has been designed to find a possible difference in pain perception between previously~     exposed and unexposed patients undergoing cosmetic procedures using energy devices.~   "
135186|NCT01285414|"~     This, international, multi-center, Phase 2 study of verubulin will be conducted in patients~     with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two~     parts. Part A is an open-label dose finding study that will determine the safety and~     tolerability of verubulin in combination with standard treatment. Part B is a randomized~     open-label study that will investigate progression-free survival and overall survival of~     patients receiving verubulin, at the dose determined in Part A, in combination with standard~     treatment versus standard treatment alone.~   "
135146|NCT01285934|"~     Type 1 diabetes mellitus (T1D) results from immune-mediated destruction of insulin-producing~     islet cells. The loss of islet cells is traditionally treated with insulin therapy and in~     some cases pancreas or islet cell transplantation. Another approach would be to preserve~     islet cell mass before it is irreversibly lost. Previous trials using immune suppression~     within 6 weeks of T1D onset have demonstrated diminished exogenous insulin requirements~     compared to untreated controls. In our prior phase I non-randomized study, by extending~     immune suppression to the point of immune ablation / immune reset with autologous HSC~     support, several patients with new onset T1D have maintained an insulin-free, drug free~     remissions for more than 4 years. Although these results appear highly promising, it may be~     argued that our results are mitigated by the documented honeymoon effect following T1D, that~     is by a normal transient insulin free interval occurring after disease onset in some~     patients. The goal of this trial is to extend this phase I study of new onset T1D to clarify~     whether our post transplant insulin free interval is due to treatment intervention~     (transplant) or a result of a normally occurring insulin free honeymoon period. Both~     groups will receive identical change of life style (i.e. diet, exercise) education.~   "
135147|NCT01285921|"~     Vestibular signals deeply influence hippocampal spatial representations and may contribute~     to the navigational deficits of humans with vestibular dysfunction. The reciprocal influence~     of hippocampal signals on the vestibular system are more putative. The investigators wish to~     investigate in this pilot study the consequences on vestibular system of the removal of the~     hippocampal formation to treat drug resistant temporal lobe epilepsy.~   "
135148|NCT01285908|"~     Background:~      - Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex~     action of the automatic nervous system makes blood vessels tighten when people stand up. The~     nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps~     blood pressure in check. In orthostatic hypotension, the nervous system does not release~     enough norepinephrine when a person stands up, which can cause fainting or falling.~     Researchers are interested in determining whether norepinephrine given as a drug by vein can~     help maintain blood pressure during changes in body position.~      Objectives:~      - To determine whether intravenous norepinephrine can maintain blood pressure in people with~     orthostatic hypotension.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension~     related to Parkinson's disease or pure autonomic failure.~      Design:~        -  This study will require a 2-day inpatient admission to the NIH Clinical Center. The~          first day will involve laboratory evaluation and the second day will involve testing~          with norepinephrine. The second day requires an overnight stay.~        -  Participants will be screened with a medical history and physical examination, blood~          samples, and an electrocardiogram or echocardiogram.~        -  Participants who are on medications may be asked to taper or discontinue one or more~          medications for the purposes of this study. Participants may not take aspirin or any~          drugs that slow blood clotting for 7 days before study participation.~        -  Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline~          tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure.~          Body temperature and breathing will also be monitored.~        -  Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt~          table test. Initial blood pressure readings will be taken, and an intravenous line will~          be placed. Participants will then receive norepinephrine or saline, followed by~          additional position changes of the tilt table to measure blood pressure differences~          before returning to the starting position. After about 10 minutes, the tilt table~          testing and infusion will be repeated with the other drug (saline or norepinephrine).~        -  Participants will be discharged 24 hours after the testing is complete.~   "
135149|NCT01285895|"~     Main objective : This project aims to assess the educational needs of patients who received~     a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.~      Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3~     to 6 months, 6 months to 2 years, more than 2 years after transplantation~      Secondary objectives :~        -  Assess the state of health~        -  Assess the knowledge~        -  Assess gestural know-how~        -  Assess the cognitive know-how~        -  Assess the behaviour adopted in reality by the patient~        -  Assess motivation psychosocial factors of :~             -  self-efficacy and inefficiency~             -  representation of obstacles, disadvantages of treatment~             -  sense of control over their health~             -  feeling of being supported by health professionals, by his close~             -  representation of his responsibility to take care of his health, to follow his~               treatment, to be active about his treatment~   "
135150|NCT01285882|"~     Main objective : This project aims to have a better understanding of the influence of~     representations of patients with mucoviscidosis, their assistants and their medical persons~     in the choice of patients to accept or not lung transplantation.~      Specific objectives :~        1. Identify the knowledge, representations, or feelings of patients which could constitute~          bridles or factors of motivation to use for transplantation.~        2. Identify the knowledge, representations, or feelings of medical persons which could~          constitute bridles or factors of motivation to the encouraging proposal to patients~          of lung transplant.~        3. Identify the knowledge, representations, or feelings of assistants which could~          constitute bridles or factors of motivation to the encouragement of lung~          transplantation at its close.~        4. Identify the needs of patients, assistants and medical persons to successfully reduce~          these bridles to transplantation and increase the factors of motivation.~        5. Compare the representations of patients, assistants and medical persons~        6. Search representations associated with patients who refuse the transplantation and~          those who accept the transplantation~   "
135151|NCT01285869|"~     The hypothesis of this study is that long-term outcome in elderly patients admitted with the~     diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP)~     would improve with a multidimensional intervention including assessment of co-morbidities,~     nutritional, functional and cognitive status and immunization.~   "
135152|NCT01285856|"~     Justification and aims of the study: The principal aim of use of opiate substitutes such as~     methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to consume~     the opiate to which the patient is addicted. Adjustment of the initial dose and regular~     re-evaluation of the efficacy of treatment are key elements in the success of such~     management. While too high a dose can be responsible for side effects leading to abandonment~     of treatment, too low a dose can induce the reappearance or even the reinforcing of parallel~     consumption of other psychoactive substances, in particular cocaine, alcohol and cannabis.~     The principal aim of this project is to determine the course of parallel consumption in~     patients who have been receiving a maintenance dose of methadone or HDB for at least two~     months, by analysis of a sample of hair, a biological matrix which is innovative for this~     type of study. Hair testing establishes a retrospective profile of consumption. The~     secondary aims of this project are (i) to validate the French versions of Handelsman's~     subjective and objective opiate withdrawal scales and to seek a possible correlation between~     high scores on these scales and the presence of parallel consumption, and (ii) to seek an~     association between polyconsumption and common functional polymorphisms of metabolic enzymes~     of methadone and HDB.~      Expected results: Hair testing, which has the particular advantage of a long detection~     window so that samples need only be taken at intervals, could improve the biological~     monitoring of patients on substitutive treatment.~      Validation of the French version of Handelsman's scales of objective and subjective signs of~     opiate withdrawal and search for any correlation with parallel consumption will enable these~     scales to be used in daily practice for clinical surveillance of patients on substitutive~     treatment.~      If a polymorphism of a metabolic enzyme of one or other of these molecules is detected,~     rapid genotyping of a simple saliva sample will be valuable in guiding the choice of~     medication when deciding on a treatment strategy~   "
135157|NCT01285791|"~     Excess visceral fat is a key factor in the development of metabolic syndrome associated with~     obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease~     in the amount of total body fat. It is unclear how the different surgical procedures vary in~     their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an~     effective, efficient method in assessing this metabolically active layer of fat even when~     compared with gold standard techniques such as computed tomography and magnetic resonance~     imaging. Only a few studies managed to show the actual decrease in the visceral fat layer~     after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of~     fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic~     sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis~     is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but~     also a malabsorptive procedure will have the best results in decreasing the amount of~     visceral fat.~   "
135158|NCT01285778|"~     Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC.~     Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical~     activity in a single report of a refractory anal canal SCC patient. Based on this~     background, we propose to conduct a phase II study to investigate the efficacy and toxicity~     of radiotherapy with the association:~        -  5-FU 1000mg/m2 on days 1-4 and 29-32~        -  Mitomycin C 10mg/m2 on days 1 and 29~        -  Panitumumab 6 mg/m2 on day 1, then every 2 weeks for 8 weeks~   "
135159|NCT01285765|"~     Localized stages DLBCL with low IPI (aaIPI = 0) have a very good prognostic after a standard~     immuno-chemotherapy with 6 cycles of R-CHOP 21. Five years PFS is estimated over 75%,~     whatever the age of the patient.~      PET scan is actually considered as the gold standard for the initial staging and the~     evaluation of response after treatment. With this new technique, the response criteria have~     been redefined by Cheson and al. in 2007. Moreover, several recent studies showed that early~     evaluation of response with PET scan after only 2 cycles of chemotherapy was accurate to~     define two groups of patients:~      Early-good-responders, when PET scan is negative Early-poor-responders, when PET scan~     remains positive Prognostic for the first group is very good, and for the second poorer. At~     the present time, the interest of the modification and/or the intensification of the~     treatment for the early-poor-responder patients is not demonstrated by any publication. New~     studies are ongoing for patients with advanced stages of DLBC NHL (GELA trial LNH 07-3B) or~     Hodgkin's lymphoma (GELA and EORTC trial H10); the aim is to evaluate a new strategy of~     treatment adapted to early response criteria.~      No trial has already been made for low IPI DLBCL. In this study, the investigators purpose~     is to evaluate the adaptation of treatment with early response based on PET scan results~     after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.~      This is an open randomized study.~      The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non~     inferiority of the experimental arm in comparison to standard arm:~      In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account~     of PET scan results after 2 cycles.~      In experimental arm, early good responder patients (defined as having a negative PET scan~     after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.~      In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam~     is needed to confirm the failure and an intensive chemotherapy is then recommended.~      All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan~     will be reviewed by a group of expert according to Deauville criteria defined by Meignan et~     al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for~     all patients. The final evaluation of response will be made according to 2007 Cheson's~     criteria.~   "
135160|NCT01285752|"~     To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid~     arthritis.~   "
135161|NCT01285739|"~     The purpose of this study was to determine occurrence of ventilator associated pneumonia~     (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation~     (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive~     mechanical ventilation (NIMV).~   "
135162|NCT01285726|"~     The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD)~     patients and its evolution over a period of four years, independent of the PD treatment~     modality (APD or CAPD) and the PD solution type.~   "
135163|NCT01285713|"~     To determine whether the addition of dextrose to IV fluids in the treatment of~     gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of~     dextrose containing fluids in the treatment of gastroenteritis will be assessed.~   "
135164|NCT01285700|"~     This is a single-center, open-label, multiple-dose study of the efficacy and long-term~     safety of Lamazym for the treatment of patients with alpha-mannosidosis.~   "
135165|NCT01285687|"~     A randomized, controlled, single-blinded study comparing conventional postoperative~     analgesia with paracetamol-on-demand with the same regime plus acupuncture.~      The hypothesis is that postoperative treatment of children undergoing tonsillectomy with~     acupuncture will reduce pain with minimal unwanted effects.~   "
135166|NCT01285674|"~     In this study we will aim to determine if cisplatin ototoxicity can be prevented by~     intratympanic administration of corticosteroids.~   "
135167|NCT01285661|"~     Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in~     patients at their first episode of proximal deep venous thrombosis (DVT) of the lower~     extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with~     minimal risk factors for thrombosis, with the help of an algorithm which incorporates both~     ultrasonography and D-dimer information. All patients will be followed-up until 1) the~     achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death;~     4) the date of study stop. The purpose of this study is to demonstrate the safety of~     withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have~     recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3~     months). The approach will be deemed to be safe if the annual rate of recurrent VTE in~     patients who will have their anticoagulation discontinued is lower than 5%.~   "
135168|NCT01285648|"~     The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and~     evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two~     groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous~     Positive Airway Pressure (CPAP) patients.~   "
135169|NCT01285635|"~     This study will examine the effects of an investigational drug called AT-101 in combination~     with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the~     Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will~     help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has~     on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop~     growing? The researchers will also learn about the safety of the combination of AT-101 and~     Docetaxel. For instance, are there any side effects? If so, what kind of side effects does~     the combination cause? How severe are the side effects, and how often do they occur?~   "
135484|NCT01281527|"~     This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of~     flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients~     previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with~     a long duration of action) antipsychotics.~   "
135170|NCT01285622|"~     The investigators propose a prospective observational trial. The investigators plan to~     enroll 40 female subjects scheduled for elective robotic gynecological surgery under general~     anesthesia. Hemodynamic data will be recorded at the following intervals: after induction of~     anesthesia (Baseline), after initiation of pneumoperitoneum, after positioning the patient~     in Trendelenburg position, and every 15 minutes thereafter. At the end of surgery~     measurements will be recorded after reversal of Trendelenburg position and after deflation~     of the peritoneum.~      Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer~     (Mallinckrodt Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples.~     Vasoconstriction will be identified when forearm - fingertip temperature gradient is ≥ 00C~     and PI <1.~      Intra-abdominal pressures will be recorded during each measurement of hemodynamic~     parameters. Trendelenburg position will be measured with an angle ruler.~      The aim of our study is to test the hypothesis that stroke volume will drop significantly~     after initiation of pneumoperitoneum and that it will increase after placement in~     Trendelenburg position in patients undergoing robotic gynecological procedures. Secondly,~     the investigators will test the hypothesis that PVI changes correlate with changes in stroke~     volume and pulse pressure variation (PPV) and can predict an increase in stroke volume after~     a fluid bolus. The third hypothesis is that delta PVI is independent of the vaso-status of~     precapillaries at the measured site.~   "
135171|NCT01285609|"~     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin~     will extend the lives of patients with squamous only non small cell lung cancer more than~     placebo plus Paclitaxel and Carboplatin.~   "
135172|NCT01285596|"~     Young and elderly, male and female subjects are each given 2 different doses of mirabegron~     for 7 days each. Levels of mirabegron in the blood are assessed.~   "
135173|NCT01285583|"~     The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to~     riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the~     preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.~   "
135174|NCT01285570|"~     Post-operative administration of ulimorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.~   "
135175|NCT01285557|"~     The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin~     compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and~     esophagogastric junction cancer previously untreated with chemotherapy.~   "
135176|NCT01285544|"~     There will be no significant differences in the efficacy and tolerability between the test~     and reference formulations of atorvastatin 20 mg in these Korean adults with primary~     hypercholesterolemia.~   "
135177|NCT01285531|"~     Objective: To evaluate pediatric emergency department provider lumbar puncture success with~     and without the Compass Lumbar Puncture Enhanced, a new pressure transducer, in order to~     determine: the proportion of lumbar punctures where a) any cerebrospinal fluid is obtained~     on the first attempt, b) any cerebrospinal fluid is obtained on any attempt, and c)~     sufficient cerebrospinal fluid is obtained for standard tests (culture, chemistries, cell~     count); the time to provider success in obtaining a) a drop of fluid from the needle, and b)~     opening pressure measurement; the proportion of successful lumbar punctures that contain~     blood; and provider satisfaction.~      Background: Lumbar punctures are necessary to diagnose meningitis, neurological diseases and~     some cancers. They are common pediatric emergency department procedures that frequently~     require repeated attempts or are only partially successful, with sufficient blood to limit~     interpretation. Measuring cerebrospinal fluid pressure during lumbar punctures is~     recommended but rarely done, due to limitations of current technology. Liquid column~     manometry is cumbersome, time-consuming and frequently impractical. Existing pressure~     transduction probes that connect via tubing to external monitors are not designed or~     recommended for lumbar punctures. The pressure is displayed on a monitor that is difficult~     to view during the LP procedure and they equilibrate too slowly to keep pace of pressure~     changes during LPs. The Compass Lumbar Puncture Enhanced is a new, inexpensive, disposable,~     medical device, specifically designed for use during LPs, that has the potential to increase~     lumbar punctures success and decrease blood contamination. It attaches to the spinal needle~     and displays both a numeric pressure value and a pressure waveform, allowing physicians to~     more readily identify the cerebrospinal fluid space and measure cerebrospinal fluid~     pressure. The device is small, easy to use, and readily incorporated into standard practice.~      The Compass Lumbar Puncture Enhanced uniquely provides immediate feedback about pressure~     that may allow physicians to more quickly and confidently identify the CSF space, and~     instantly determine cerebrospinal fluid pressure when the space is reached. The~     investigators believe the Compass Lumbar Puncture Enhanced will increase lumbar punctures~     success and decrease the proportion containing blood. It has the potential to become the~     standard of care and be used in every lumbar puncture procedure. This study is expected to~     demonstrate the clinical utility of the Compass Lumbar Puncture Enhanced to the medical~     community. Increased awareness of the Compass Lumbar Puncture Enhanced and a positive~     demonstration of the viability of the technology will help attract either the investment~     capital or the strategic partnership necessary to fully develop the market.~   "
135178|NCT01285518|"~     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability~     and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.~   "
135179|NCT01285505|"~     This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual~     formulation is the same as that from an existing sublingual formulation.~   "
135180|NCT01285492|"~     This is a 52-week treatment, multi-center, randomized, open label, parallel group study to~     assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237~     ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with~     moderate to severe chronic obstructive pulmonary disease (COPD).~   "
135181|NCT01285479|"~     The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis~     (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic~     effects in the offspring of women exposed to Gilenya before (up to 8 weeks before last~     menstrual period) and during pregnancy in routine clinical practice. The overall aim is to~     collect and evaluate data on maternal, fetal, and infant outcomes and compare it with~     reference populations.~   "
135182|NCT01285466|"~     The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and~     BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.~   "
135183|NCT01285453|"~     This study will assess the tolerability of combination therapy with ASA404 and docetaxel in~     Japanese patients with advanced or recurrent solid tumors.~   "
135184|NCT01285440|"~     The purpose of this study is to show that improvements in the molecular breast imaging (MBI)~     technology will allow reduction of the administered dose of Tc-99m sestamibi while~     maintaining a sensitivity of 90% for tumor detection.~   "
135185|NCT01285427|"~     The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and~     uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with~     UniMatch(R) interpretation software and show 95% concordance with 90% confidence.~   "
135507|NCT01281215|"~     The purpose of this study is to develop, implement and evaluate an economically viable and~     efficient interventions education model for rational drug use, adaptable to different~     pathological situations and should be implemented into Brazil Heath Care System.~   "
135187|NCT01285401|"~     The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone~     supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated~     with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of~     patients with Multiple Sclerosis have Vitamin D deficiency.~      Rebif® is known to be an effective treatment for slowing down the progression of MS. The~     purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any~     benefit on the progression of MS compared to Rebif® and placebo.~      Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging~     (MRI). The planned study treatment duration for each study participant is 48 weeks, and the~     study consists of a total of 8 visits. Study participants who are already passed Week 48 at~     the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a~     total of 12 visits.~      During the study, the participant will undergo physical examination, neurological~     assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).~   "
135188|NCT01285388|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after a~     single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a~     single oral dose.~   "
135189|NCT01285375|"~     The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin~     complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and~     highly effective in preventing primary graft non-function, delayed graft function and~     chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is~     that addition of CDC to the graft perfusion solution will decrease the incidence of delayed~     graft function in human kidney transplantation subjects.~   "
135190|NCT01285362|"~     Over the past 30 years, the prevalence of childhood obesity in the United States has tripled~     from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes,~     cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology~     encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage~     liver disease. Weight loss, particularly if gradual, may lead to improvement in liver~     histology. Unfortunately, few patients in the pediatric population are willing to follow~     these recommendations and achieve weight loss. Medical treatment directed specifically at~     the liver disease has only recently been investigated and approved in patients with NAFLD.~     The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty~     acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major~     regulators of pathways that participate in decreased production and break down of~     triglycerides and fatty acids in the liver. We hypothesize that children with obesity~     related NAFLD will normalize elevated liver enzymes, plasma lipid levels, and attenuate~     insulin resistance with supplements of n-3 fatty acids. If this hypothesis is proven true,~     then fish oil could be used to treat NAFLD and to prevent the deterioration of fatty liver~     into end-stage liver disease.~   "
135191|NCT01285349|"~     This randomized controlled trial is designed to address gaps in couple-based HIV prevention~     research by focusing exclusively on HIV negative concordant couples where one or both~     partners are drug-involved. Building on prior couple-based HIV research that resulted in an~     evidence-based HIV prevention model for couples (Connect), intervention components were~     modified to address dyadic drug risk reduction and drug-related unsafe sex and a~     couple-based HIV risk reduction intervention (Connect II) was designed specifically for~     drug-involved, HIV negative concordant heterosexual couples at risk for HIV/STIs. For this~     RCT, couples are recruited primarily through street outreach in drug using locations and~     randomized into one of three arms: (1) couple-based HIV Risk Reduction condition; (2)~     individual-based HIV Risk Reduction, which delivered the same content as the couple-based~     condition but was provided to either the male or female drug-using partner alone; or (3)~     couple-based Wellness Promotion, which served as an attentional control arm. This RCT tests~     two major hypotheses: (1) whether the HIV risk reduction intervention provided to the couple~     or an individual partner would be more efficacious in decreasing number of unprotected acts~     of intercourse and having a lower cumulative incidence of biologically confirmed STIs over~     the 12-month follow-up period compared to the Wellness promotion control arm and (2) whether~     the couple-based HIV risk reduction intervention would be more likely to decrease the number~     of unprotected acts and have a lower cumulative STI incidence compared to the Individual HIV~     Risk reduction Arm.~   "
135192|NCT01285336|"~     This study is valuable for the understanding the role of DNA repair system plays in the~     progression of rheumatoid arthritis and for the development of new therapeutic modality in~     the future.~   "
135193|NCT01285323|"~     The primary objective of this study is to determine whether reslizumab is more effective~     than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with~     eosinophilic asthma.~   "
135194|NCT01285310|"~     The purpose of this study is to determine whether Apremilast is safe and effective in the~     treatment of patients with rheumatoid arthritis, specifically in improving signs and~     symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and~     structure) in treated patients who have had an inadequate response to Methotrexate.~   "
135195|NCT01285297|"~     The purpose of this study is to determine the safety of injecting autologous bone marrow~     concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which~     cannot be treated by direct coronary intervention.~   "
135196|NCT01285284|"~     This study will evaluate the efficacy of music (a very well selected list of songs)on~     improving the tolerance to the colonoscopy. The patients will be randomly assigned to~     receive music or not. The authors hypothesis is that music is able to improve the tolerance~     to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain~     experimented during the procedure and a reduction of the administered dose of midazolam~     during the colonoscopy.~   "
135197|NCT01285271|"~     The aim of this study is to determine whether xenon - as compared to sevoflurane - can be~     applied safely in patients for general anesthesia before and after CABG implantation.~   "
135198|NCT01285258|"~     The purpose of this study is to determine the effects of peripartum hysterectomy for~     maternal hemorrhage.~   "
135199|NCT01285245|"~     The purpose of this study is to test whether anakinra is able to reduce insulin resistance.~      This will be tested in overweighted type I diabetes mellitus patients, which have no~     residual beta-cell function. By using this patient group, all positive effects on glycemic~     control should be the consequence of improved insulin sensitivity.~   "
135201|NCT01285219|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim~     administration has long been established as the standard of care. A pegylated filgrastim was~     independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed~     of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal~     residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim~     has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare~     with ﬁlgrastim. These characters were similar to those of Neulasta.~      The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare~     the efficacy and safety of a single injection of pegylated filgrastim and daily injections~     of ﬁlgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis~     is that pegylated filgrastim is similarly effective and safe with regular filgrastim.~   "
135202|NCT01285206|"~     Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery~     suffer more complications, such as wound infections and increased blood loss, resulting in~     more blood transfusions and longer hospital stays than those who don't.~      There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause~     significant adverse effects. Although there is much evidence regarding the effectiveness of~     warming for long operations, there is nothing looking at short procedures such as those~     undertaken in the daysurgery setting.~      A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in~     volunteer studies, to be as effective as forced air warming blankets (which are used for~     long operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is~     reusable and has lower running−costs so is likely to be cheaper in the long term. This is~     particularly relevant in the day surgery setting where high numbers of patients are operated~     on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it~     can be applied from the moment the patient goes to sleep to the moment they wake up so it~     could actually prove more effective at preventing hypothermia in the clinical setting. This~     study aims to determine whether the carbon polymer blankets can reduce the incidence of~     hypothermia in the day surgery (ie. short operating time) setting.~   "
135203|NCT01285193|"~     The purpose of this study is to determine if blood pressure can be reduced in hypertensive~     subjects by regularising and slowing their breathing. This may be a safe and affordable~     complementary treatment for hypertension.~   "
135204|NCT01285180|"~     Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4)~     for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic~     cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment.~     With its mode of action Daxas can reduce exacerbations rates and improve lung function~     parameters which may result in a better health-related quality of life and an improved~     long-term management of COPD.~      The aim of this non-interventional study is to evaluate data on quality of life in COPD~     patients in Germany in a real life medical setting. Evaluation is based on two COPD specific~     questionnaires to assess the patient`s health status over six months. During the study,~     socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be~     administered once daily. The study will provide further data on the safety and tolerability~     of Daxas.~   "
135205|NCT01285167|"~     Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung~     disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness,~     cough and sputum. As COPD progresses, patients experience increasing deterioration of their~     health-related quality of life, with greater impairment in their ability to work and~     declining participation in social and physical activities.~      The aim of this non-interventional study is to evaluate data on quality of life in COPD~     patients in Germany in a real life medical setting under therapy with the~     phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD~     specific questionnaires to assess the patient`s health status over six months. During the~     study, lung function measurements such as spirometry will be conducted according to common~     medical standard. Daxas (tablet) will be administered once daily. The study will provide~     further data on the safety and tolerability of Daxas.~   "
135206|NCT01285154|"~     Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young~     adults with three incisions to increase the coverage; however the amount of correction~     remained questionable due to ligamentous attachments that hinder the rotation. The~     investigators modified the technique with two anterior incisions and ramus cuts close to~     inferior acetabulum. The purpose of this study is to compare these two techniques in femoral~     head coverage~   "
135207|NCT01285141|"~     A vaccine to prevent infection with the Human Immunodeficiency Virus (HIV) is urgently~     needed. Worldwide, most HIV infections occur through sex between a man and woman. The~     vaccine in this study consists of a protein from HIV that has been synthetically produced~     and linked to a protein that boosts immune responses. It has not been tested in humans~     before, but it is expected (from animal studies) that direct application into the female~     genital tract (via the vagina) as liquid drops, will provoke immune protection at the site~     of HIV infection. This is less applicable to men, therefore only healthy, HIV negative women~     will be recruited. The investigators will recruit at one site, which is a university vaccine~     research centre with experience of running similar trials. The study will last 24 weeks~     during which subjects will have blood samples taken on six visits, and three immunisations~     over 12 weeks in which 1 millilitres of vaccine is placed into the vaginal by inserting a~     small plastic syringe. The purpose of this initial small study is to monitor safety of the~     vaccine and to determine whether it is appropriate to continue into future, larger studies~     in which the immune response to the vaccine is measured.~   "
135208|NCT01285115|"~     In this randomized, double blinded, Parallel-controlled study, the investigators planned to~     give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of~     generalized anxiety disorder according to dosage form.~   "
135209|NCT01285102|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells or stopping them from~     dividing. Chemoembolization kills tumor cells by blocking blood flow to the tumor and~     keeping chemotherapy drugs near the tumor.~      PURPOSE: This phase II trial is studying how well chemoembolization using irinotecan works~     in treating patients with liver metastases from metastatic colon or rectal cancer.~   "
135210|NCT01285089|"~     This study is conducted in Europe. The aim of this prospective, observational study are to~     describe the different clinical practice and detailed haemostatic management of activated~     recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France.~     The secondary aim is to assess the primary haemostasis disorder associated with the~     coagulation disorders, if available.~   "
135211|NCT01285076|"~     This is a multi-center, observational, retrospective and cross-sectional study to be~     conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus~     (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF)~     combination therapy by their cardiologist, nephrologist, neurologist, or family practice~     doctor for at least 6 months prior to Study Enrollment.~   "
135212|NCT01285063|"~     The goal of the this study is to create an interdisciplinary program which includes~     intervention in the fields of nutrition, physical activity and behavior in order to treat~     obesity and overweight among kindergarten children and to examine the influence of such~     program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields~     among the participants.~   "
135213|NCT01285050|"~     The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type~     specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/~     HCV (hepatitis C virus) coinfected persons before and after administration of HIV~     medications (antiretroviral therapy).~   "
135214|NCT01285037|"~     Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to~     participants with advanced cancer and to determine any side effects that may be associated~     with LY2801653 in this participant population. Efficacy measures will be used to assess the~     activity of LY2801653.~      Part B- The dose determined in Part A will be used along with efficacy measures to assess~     the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head~     and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and~     cholangiocarcinoma.~      Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653~     that may be safely given to participants with HNSCC when taken with standard doses of~     cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of~     LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a~     standard dose of cisplatin.~      Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653~     that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine~     plus cisplatin.~      Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653~     that may be safely given to participants with gastric cancer when taken with ramucirumab.~   "
135215|NCT01285024|"~     This is a prospective, randomized, controlled, single-center study to assess the~     effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty~     (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects.~     Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary~     unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel~     or any other hemostatic agent except those that are standard during a primary THA. The study~     will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.~   "
135216|NCT01285011|"~     Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the~     most frequently affected, but the other small toes may also be involved. When nonoperative~     treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the~     Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:~        -  Internal fixation;~        -  Interphalangeal Compression;~        -  Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for~          this specific arthrodesis. The objective of this study is to evaluate the efficacy and~          safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.~      The safety of the Ipp-On will be described in terms of rate of device related complications.~      The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.~   "
135217|NCT01284998|"~     In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy~     may be more indicated than the distal osteotomy as it allows to achieve a greater degree of~     correction.~      However, weight bearing forces on the head of the first metatarsal acting at a distance from~     the osteotomy site subject the construct to an important dorsiflexion stress. Fixation~     strength being the important consideration led to design the B-BOP® Lock plate, specifically~     dedicated to basal osteotomy of the first metatarsal, with the following characteristics:~        -  plantar positioning to obtain the best stability and resistance while reducing the~          implant bulkiness;~        -  anatomical shape adapted to the plantar curve of the first metatarsal. Taking~          advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate~          directly on tension, it offers an innovative and unique basal osteotomy fixation~          solution.~      The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.~      The purpose of this study is to collect and publish data from several centers, several~     users.~   "
135231|NCT01284816|"~     Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese~     patients, especially those with metabolic complications, as it significantly reduces weight,~     hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and~     in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic~     improvement is associated with EAT reduction is also unknown.~      The researchers thus investigated the effect of bariatric surgery on EAT in severely obese~     patients. The primary endpoint of this study was the change in EAT amount 6 months after~     bariatric surgery.~   "
135232|NCT01284803|"~     Qualitative study based on interviews and questionnaires with patients participating to an~     educational intervention to improve the management of depression in primary care.~      Objective is to assess feasibility and acceptability of an educational intervention to~     improve the management of depression in primary care To elaborate an educational program for~     the management of depression in primary care.~   "
135264|NCT01284387|"~     A Phase II clinical research study to evaluate the efficacy and safety of two different dose~     levels of an injectable investigational treatment (ACC-001) in subjects with~     Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid~     fragment attached to a carrier protein. It is intended to help induce an antibody response~     against beta amyloid and is administered as an intramuscular injection.~   "
135218|NCT01284985|"~     The great toe is vital for normal, pain free ambulation. Decreased function associated with~     osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis~     or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation~     especially during the push-off phase of gait. When surgery is indicated four techniques are~     used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant~     surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the~     arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular~     bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without~     polyethylene articulations, have been more successful (3). Still, implants are prone to wear~     of the material and show higher rates of loosening and infection compared to other~     techniques (4;5). In the last decades several new implants are described using two non~     cemented pressfit components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the~     investigators developed a new concept with instrumentation for exact alignment to prevent~     for wear with loosening of the implant on the long term. The implant has bone-conserving~     characteristics to enable arthrodesis as a salvage procedure. It is a completely modular~     two-component press fit titanium alloy implant with polyethylene insert that can be used as~     either for hemi-, total- or revision arthroplasty.~      The purpose of this study is to have an overview of clinical status of the patient implanted~     with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study~     is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at~     short term follow up.~   "
135219|NCT01284972|"~     The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that~     consists of a flat tibial component, an anatomically-shaped talar component, and a~     high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt~     to address the needs of minimal bone resection, extended bone support, proper ligament~     balancing, and minimal contact stressed within and around the prosthesis.~      The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total~     Ankle prosthesis at short and mid term follow up.~   "
135220|NCT01284959|"~     The main objective of this study was to assess subjective experiences related to secondary~     negative symptoms and cognitive performance in healthy volunteers in response to multiple~     doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial.~     Adverse events caused by these drugs were also evaluated.~   "
135221|NCT01284946|"~     While clinical phlebotomy is current standard practice for alleviating non-transfusion iron~     overload in patients with PCT, it may not be suitable for all patients. For example, some~     patients are unwilling to be adequately phlebotomized because of inconvenience, as~     phlebotomy can be cumbersome, especially during the induction treatment phase requiring~     frequent clinic visits (twice a month, for at least 6 months) or because of venous access~     difficulties. Other patients are unable to undergo phlebotomy due to medical reasons such as~     anemia or cardiopulmonary disorders. It is postulated such patients with PCT who have~     non-transfusion iron overload could benefit from treatment with deferasirox (Exjade®), a~     once daily oral iron chelator licensed in several countries, including the EU, for treating~     transfusion iron overload in adult and pediatric patients. Although there is some data on~     the efficacy and safety of deferasirox in patients with HH, who, like those with PCT, have~     non-transfusional iron overload, there is a need to evaluate the safety and efficacy of~     deferasirox treatment of non-transfusion iron overload in patients with PCT.~   "
135222|NCT01284933|"~     The purpose of this study is to determine the frequency, characteristics, and consequences~     of vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the~     territory of the internal carotid artery.~   "
135223|NCT01284920|"~     This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100~     after oral administration to patients with castration-resistant prostate cancer.~   "
135224|NCT01284907|"~     The purpose of this study is to determine whether vitamin D supplements can improve asthma~     control in children with moderate to severe asthma~   "
135225|NCT01284894|"~     Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy,~     patients with dysphagia are referred for esophageal motility testing. Esophageal manometry~     is the gold standard to evaluate esophageal motility in absence of esophageal obstruction.~     Two different techniques are available: the conventional manometry and the high resolution~     manometry. The second one may improve the diagnostic yield and the tolerance of examination~     in patients with dysphagia.~   "
135226|NCT01284881|"~     Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a~     treatment option for sleep-disordered breathing (SDB).~      The purpose of this study is to compare active measurement of MRA compliance with patient's~     self-report.~   "
135227|NCT01284868|"~     To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will~     be given a beta-blocker at the same time as mirabegron.~   "
135228|NCT01284855|"~     This study aims at comparing two doses of antivenom in the treatment of snake bite~     envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite~     victims presenting with one or more sign of neurotoxic envenoming. The objective of the~     study is to generate enough scientific evidence to improve Nepal's current national~     guidelines for the management of snake bites.~   "
135229|NCT01284842|"~     The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep~     deprivation on surgical residents` technical and cognitive performance in a virtual reality~     (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of~     sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were~     assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective~     alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were~     performed on three consecutive mornings- pre- and post-call as after 24 hours resting.~   "
135230|NCT01284829|"~     This is a prospective study which aims to validate a new diagnostic approach in the tissue~     characterization of adrenal tumors indeterminate on conventional imaging. For this purpose,~     it is not necessary to have a control group since the diagnostic accuracy in a well defined~     subset of patients.~      Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3~     : 6 months post-PET. Visit 4 : 12 months post-PET.~   "
135233|NCT01284790|"~     Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people~     worldwide. While most patients show good scores of speech recognition in quiet, a large~     majority of them also struggle in more challenging listening situations, such as speech in~     noise or music. This project aims to understand the basic mechanisms of electrical~     stimulation of the auditory nerve, in order to identify the important cues that the~     electrical signal should convey and to possible improve sound perception by CI users.~   "
135234|NCT01284777|"~     Accurate characterization of malignant cells obtained via thoracocentesis is of paramount~     importance in the management of cancer patients. The identification of novel biomarkers may~     in that regard considerably improve the diagnostic approach of these pleural effusions,~     guide therapeutic decisions, particularly with respect to targeted therapies, and offer~     helpful prognostic information. Nuclear anomalies represent the cornerstone of the cytologic~     and/or histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental~     constituent of the nuclear architecture via its interaction with the nuclear membrane, but~     is also directly involved with DNA and RNA processing. Prior studies have suggested that in~     some cancers, the lamins, a major constituent of the nuclear matrix, have different patterns~     of expression or nuclear localization that could potentially have prognostic implications.~     Our project aims at studying the constituents of the nuclear matrix of malignant cells~     isolated for pleural fluid in patients with metastatic disease, both of bronchogenic or~     non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic~     (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray,~     CGH type) analyses will be undertaken to identify microrearrangements in the genes of~     interest. The primary aim is to identify specific biomarkers to more accurately characterize~     malignant cells in metastatic pleural disease.~   "
135235|NCT01284764|"~     A low volume of water intake and mosapride will effectively reduce food residue in remnant~     stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.~   "
135236|NCT01284751|"~     The purpose of this study is to measure depressive symptoms in breast cancer patients before~     surgery with Major Depression Inventory (MDI). The investigators hypothesize that this~     patient group will not produce scores correlating to having a mild, moderate or severe~     depression even though they have just recently experienced a major life crisis by receiving~     a malignant diagnosis.~   "
135237|NCT01284738|"~     The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in~     thalassemic patients and to underline a possible difference between TM and TI. The in vitro~     and in vivo study of MP in erythrocytes concentrates is a new approach to explore the~     consequence of transfusion in polytransfused patients. Finally, the identification of a~     possible relationship between the oxidative stress and the production of MP may lead to the~     development of specific therapeutical approaches~   "
135238|NCT01284725|"~     The investigators wish to evaluate the discontinuation of maintenance immunosuppressive~     treatment after 2 years in patients with stable remission after a proliferative lupus~     nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly~     associated with low dose corticosteroids.~   "
135239|NCT01284712|"~     Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective~     expression of HLA class I molecules and are complementary to specific cytotoxic T~     lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic~     malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms.~     This defect is at least partially linked to a decreased or absent expression of some~     activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors~     (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK~     cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary~     thrombocytosis, polycythemia vera). The investigators more particularly focused their~     attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease~     characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The~     investigators will precise the mechanisms leading to this cytotoxicity defect, the~     investigators also will evaluate the implication of V617F mutation on NK physiology, and~     will study the interactions between NK cells and hematopoietic progenitors.~   "
135240|NCT01284699|"~     The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in~     Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but~     presenting also with clear contraindications to the implantation of the deep brain~     electrodes.~   "
135241|NCT01284686|"~     Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is~     abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in~     untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels~     inversely correlates with motor impairment. Moreover, these different levels in BG-cortical~     loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment~     following treatment with dopaminergic drugs and is partially suppressed prior to and during~     voluntary movements. An unanswered question is how do BG-cortical loops become so~     prominently engaged in this oscillatory activity? One possible explanation is that the~     resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that~     oscillations in this band are transmitted particularly well. This hypothesis was confirmed~     in a previous series of experiments.The aim is to determine whether the resonance frequency~     within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20~     subjets during 24 months).~   "
135242|NCT01284673|"~     Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain~     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal~     damage and loss.~      For the moment, only total or partial body hypothermia can partially prevent cell loss.~     However, no treatment exists to restore neuronal functions.~      Cord blood stem cells are a promising treatment for the near future. However, before~     conducting a clinical trial to evaluate the safety and feasibility of autologous cell~     therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in~     situation of neonatal asphyxia, compared to normal situation, is needed.~      The primary objective of this study is to characterize cord blood stem cells of neonates~     with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative~     and qualitative, functional characterization will insist on cell populations which could~     potentially participate to neuronal regeneration. Secondary objectives are to assess such~     characteristics in conditions of cryo-preservation, compared to fresh cell preparation~   "
135243|NCT01284660|"~     The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on~     novel supplement on quality of life, cognitive function, craving and psychosocial factors in~     heavy cigarette smokers. In humans, no previous randomized, double blind controlled study~     has been conducted to evaluate these effects. The aim of the study is to 1. Test~     Docosahexaenoic Acid (DHA) beneficial effects on objective clinical indicators of cognitive~     function (choice reaction time, decision making, impulsivity, facial recognition) in smokers~     2. Improvement of quality of life, cigarette craving, psychosocial factors and~     self-perceptions in smokers treated with DHA supplement~   "
135244|NCT01284647|"~     The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic~     erosive gastritis and its therapeutic mechanism~   "
135245|NCT01284634|"~     The purpose of this study is to assess the effect of cannabidiol (CBD) on liver triglyceride~     (liver fat) in subjects with fatty liver disease.~   "
135246|NCT01284621|"~     Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if~     ramipril affects the pharmacokinetics of BI 10773.~   "
135247|NCT01284608|"~     This is an observational, prospective, non-interventional and multi-centre study, to assess~     the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose,~     body fat distribution and fracture risk to ten years using FRAX model in patients with~     prostate cancer. The patients will be following for 12 months~   "
135248|NCT01284595|"~     Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose~     Oral Administration~   "
135249|NCT01284582|"~     Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the~     cholesterol ester transfer protein (CETP), in healthy male subjects with high density~     lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.~   "
135250|NCT01284569|"~     The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the~     receptor for interleukin 6 (IL6R), is safe and effective after single or multiple~     administrations to patients with rheumatoid arthritis (RA). Patients will receive different~     single or multiple doses of either placebo or ALX-0061.~   "
135251|NCT01284556|"~     Primary:~      - to evaluate the efficacy of phenobarbital in reducing seizure frequency.~      Secondary:~        -  to confirm dose response relationship,~        -  to assess the effects on Type I seizures,~        -  to assess the safety of phenobarbital~        -  to assess the drug tolerability.~   "
135252|NCT01284543|"~     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the~     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared~     to the Busin glide.~   "
135253|NCT01284530|"~     Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of~     TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects~     with epilepsy.~   "
135254|NCT01284517|"~     Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.~     This clinical study is designed to test the hypothesis that Lurasidone in combination with~     either Lithium or Divalproex is effective among patients with bipolar I depression.~   "
135255|NCT01284504|"~     The proposed study aims to investigate how the administration of a drug known to reduce~     inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a~     patient undergoing primary tumor resection surgery for colon cancer. The proposed project is~     an exploratory study, and will use data from blood samples and tumor samples to attempt to~     elucidate the immune and inflammatory response in colon cancer patients undergoing primary~     resection of their tumors.~   "
135256|NCT01284491|"~     The objective of this clinical study is to evaluate scar quality following incision with the~     PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to~     compare these results to equivalently-aged scars formed following incision with a standard~     scalpel.~   "
135257|NCT01284478|"~     The purpose of the study is to determine where a sustained steroid delivery system~     (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients~     after Cataract Surgery~   "
135258|NCT01284465|"~     The purpose of this study is to assess the extent to which a culturally appropriate,~     self-management intervention that combines patient education with a patient outreach liaison~     strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.~   "
135259|NCT01284452|"~     Severe sepsis/septic shock is a serious condition associated with high mortality rate.~     Hydrocortisone has been recommended as a useful treatment to decrease mortality in~     hemodynamically unstable septic shock patients, not response to fluid and moderate dose of~     vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction~     can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome~     (ARDS) is one of the common organ dysfunction associated with septic shock. Information from~     a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS~     patients' outcome. Whether hydrocortisone can effectively prevent disease progression and~     death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been~     proven.~   "
135260|NCT01284439|"~     To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the~     treatment of ocular surface disease in glaucoma patients.~   "
135261|NCT01284426|"~     The purpose of this study is to examine the natural history of chronic urticaria in children~     and to identify the predictors for chronic urticaria remission.~   "
135262|NCT01284413|"~     The objective of this study is to evaluate the safety of GCS therapy for phase I and~     efficacy of GCS therapy for phase II.~   "
135263|NCT01284400|"~     Although many studies have demonstrated the efficacy of disease management programs on~     mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure~     (HF), no study has focused on psychological status as an outcome of disease management in~     patients with HF. Disease management could lead to the reduction of psychological distress,~     thus improving the self-care ability and adherence of patients with HF. In addition, very~     little information is available on the effectiveness of disease management programs in areas~     other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and~     Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the~     efficacy of home-based disease management programs compared with usual care in improving~     psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.~   "
135265|NCT01284374|"~     The objectives of this study are:~        1. To better understand factors associated with acceptance and refusal of HPV vaccine~          among parent-son pairs and the process of parent-son decision-making with respect to~          vaccination.~        2. To evaluate health care providers (HCPs) attitudes, implementation intentions, and~          planned communication strategies with respect to HPV vaccination of adolescent boys.~      Hypothesis 1: Sons will have a significant role in the process of parent-son decision-making~     about HPV vaccination. The relative importance of this role will increase with the son's~     age.~      Hypothesis 2: Pediatric HCPs will be unsure about vaccinating males and will lack knowledge~     about issues related to male HPV infection and vaccination.~   "
135266|NCT01284361|"~     This is an unblinded, multi-center, randomized, controlled, cross-over study assessing~     wheel-chair bound, male user preference and catheter characteristics of two intermittent~     urinary catheters. Subjects enrolled in the study will be randomized to order of catheter~     use. Individual participation will consist of approximately 1 week of product use. The null~     hypothesis to be tested is there no difference between catheters.~   "
135267|NCT01284348|"~     The purpose of this study is to determine an effective and safe dose of ACE-011 for the~     treatment of chemotherapy induced anemia (CIA) in patients with metastatic non-small cell~     lung cancer who are being treated with first-line platinum based chemotherapy.~   "
135268|NCT01284335|"~     The purpose of this study is to determine a safe dose of LY573636-sodium when used in 5~     separate combinations with an approved cancer medication for treating patients with advanced~     cancer. Data from this study will be reviewed for any side effects or anti-tumor activity~     that may be associated with the LY573636-sodium combination treatments.~   "
135269|NCT01284322|"~     The purpose of this study is to determine if fresolimumab is safe in treating people with~     systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin~     of these individuals.~   "
135270|NCT01284309|"~     The purpose of this study is to assess the affect of mirabegron on intraocular pressure~     (IOP) in healthy subjects.~   "
135271|NCT01284296|"~     This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive~     hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the~     effect of enhanced circulation to the finger (which will be attached to the sensor)~     following a local injection (digital block) of lidocaine (an FDA approved local anesthetic),~     and assess the accuracy of the SpHb reading as it relates to a standard laboratory~     hemoglobin value (tHb).~   "
135272|NCT01284283|"~     This post-approval study is being conducted to examine the performance of the STAR Ankle~     under actual conditions of use.~   "
135273|NCT01284270|"~     The purpose of this study is to evaluate whether some features of plaques in coronary~     arteries predispose the heart muscle to injuries during angioplasty in patients with a~     narrowing in at least one of the arteries that may need a stent placed during a heart~     catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI)~     study before the heart catheterization to look for scarring in the heart muscle. During the~     heart catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look~     at the make-up of the plaques before the stent placement and the investigators will measure~     the pressures in the arteries to look at how severe the blockage is. Within 30 days after~     the heart catheterization, participants will have a second MRI done to look for any new scar~     in the heart muscle.~   "
135274|NCT01284257|"~     The MORE Observational Study follows real-world renal transplant patients with the data~     resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing~     detailed clinical data, the study describes recent important changes in surveillance testing~     and drug therapy and relates these changes to short and long-term outcomes. Also, the study~     measures patient compliance over time and details the rationale for modifications of MPA~     dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide~     information on era changes in transplant practices and their impact on clinical outcome, new~     insights on optimizing regimens for discrete patient subsets and new perspectives on the~     optimal use of MPA therapy.~   "
135275|NCT01284244|"~     Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an~     increase in abdominal pressure, caused either by a loss of support under the bladder neck,~     or intrinsic urethral sphincter deficiency. It is a common problem in women that can~     significantly impact quality of life, with up to 30% developing SUI at some point in their~     lifetime.~      The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises,~     or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a~     surgical procedure. Also, women who are poor candidates for surgery have limited options if~     Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to~     develop effective non-surgical alternatives for treating SUI, but the results have been~     variable and the available data on efficacy limited.~      A new intravaginal incontinence pessary (Uresta) has been developed for treating stress~     incontinence, and is currently available in Canada via a medical distributor. The~     self-positioning device is initially fitted by a healthcare provider, but then can~     subsequently placed by the patient as needed. Uresta is designed to be easily inserted into~     the vagina and spontaneously fall into position, providing support beneath the urethra. A~     single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary~     incontinence measures, with no reported complications. Using questionnaires, a 47% reduction~     in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an~     objective assessment of urine loss, showed a 50% reduction in leakage.~      This trial is intended to be a short-term assessment of the efficacy of the Uresta device,~     using a placebo arm in order to remove any of the possible sources of patient biases. The~     placebo (sham) group will be obtained by placing a flexible silastic ring (inactivated~     Estring) high in the vagina where it will not alter urethral forces. The aim is to~     unequivocally determine whether the Uresta device provides the necessary urethral support to~     stop urine leakage from stress incontinence.~      The hypothesis is that the Uresta device will significantly reduce urinary losses from~     baseline, shown as a significant reduction pad weight following a pad test with the device~     in place.~   "
135276|NCT01284231|"~     To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult~     subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal~     adenocarcinomas who have no available standard or curative treatments.~   "
135277|NCT01284218|"~     To examine the differences in health care utilization and costs between MDD patients on~     adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.~   "
135278|NCT01284205|"~     The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG~     as first line treatment in patients with non-muscle invasive bladder cancer that are at high~     risk for recurrence or progression.~   "
135279|NCT01284192|"~     This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with~     advanced malignancies (solid tumors and B-cell lymphoma).~   "
135280|NCT01284179|"~     The primary aim is to develop and test the feasibility of a standardized digital audio~     home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).~      The secondary aims of this study are:~        1. To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis~          in refractory FCP for an anticipated future, larger treatment trial;~        2. To determine the stability of the treatment effect of HHT in refractory FCP;~        3. To assess the relationship between response to HHT and psychological factors; and~        4. To assess the relationship between response to HHT and symptomatic dimensions of chest~          pain (severity, frequency, and duration).~        5. To assess the difference~   "
135281|NCT01284166|"~     This study will investigate the safety and efficacy of Triple Combination Therapy with~     dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with~     glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol~     maleate combination therapy.~   "
135282|NCT01284153|"~     This study has the purpose to investigate the benefit of treating breast cancer patients in~     prone position. This treatment is compared to the standard technique in our center (supine~     position with or without respiratory gating). The investigators want to compare the doses on~     the organs at risk (heart and lungs) in the different techniques.~   "
135283|NCT01284140|"~     The goal of this project is to determine whether the sleep and circadian rhythms of~     critically ill patients undergoing mechanical ventilation can be improved through practical~     strategies that can be employed at the bedside.~   "
135284|NCT01284127|"~     Superficial siderosis is a progressive neurological disease caused by iron deposition in the~     central nervous system from chronic subarachnoid bleeding. Until 2011, there has been no~     effective treatment for this progressive condition that leads to hearing loss, spasticity,~     weakness, loss of bowel/bladder function, incoordination, dementia and ultimately death.~      Last year, we demonstrated that a lipid soluble iron chelator, deferiprone, can reduce~     hemosiderin deposition in patients with superficial siderosis by MRI in as little as 3~     months. As the only therapy that can improve this condition, chelation with deferiprone is~     the standard of care for treatment of superficial siderosis. Now that the FDA has approved~     deferiprone in the United States for thalassemia, we propose documenting the clinical effect~     of deferiprone over 2 years in superficial siderosis patients. Our goal is to understand how~     the clinical course of this disease is altered using standard of care chelation therapy with~     deferiprone.~      Patients with superficial siderosis who are taking deferiprone for chelation therapy at~     doses consistent with the standard of care will be offered enrollment into this~     observational study. Patients will be treated and monitored locally by participating~     neurologists who have agreed to help us collect information for this study. We are~     interested in documenting the clinical effect of deferiprone on hearing, ataxia and~     myelopathy using standardized scales performed and documenting the effect of deferiprone on~     hemosiderin deposition in the CNS by MRI, all performed according to standard of care.~   "
135285|NCT01284114|"~     The purpose of this study is to determine whether aliskiren is effective in the treatment of~     blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease~     (CKD) patients.~   "
135286|NCT01284101|"~     The Tan EndoGlide device results in less endothelial cell trauma during insertion of the~     donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared~     to the Forceps.~   "
135287|NCT01284088|"~     The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime~     risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.~      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men~     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the~     government is continuing to study the PrePex™ device, developed to enable rapid adult male~     circumcision in resource limited settings.~      The study will enroll one hundred and fifty (150) persons scheduled for voluntary~     circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™~     arm which will include about a hundred and twenty (100) subjects and surgical circumcision~     arm which will include about sixty (50) subjects.~      Study duration per subject will be 9 weeks.~   "
135288|NCT01284075|"~     This pilot study will be a prospective, randomized trial which will take place at the~     University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the~     time of their first clinic visit. If selected to be involved in the study, the patients will~     be randomized to one of three different groups: a Guided Imagery and Music therapy group~     (GIMT) or one of two control groups.~   "
135289|NCT01284062|"~     This study represents the first investigation of anrukinzumab in patients with active~     ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism~     based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and~     hs-CRP). It will provide further assessment of the safety, tolerability, and~     pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.~   "
135290|NCT01284049|"~     The objective of the study is to show that substitution of the usual lipid emulsion~     (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition~     (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid~     emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression~     of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.~      Regression of liver disease will be defined by normalization of the five liver function~     tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT~     transaminases.~   "
135291|NCT01284036|"~     The purpose of this study is to find the safety and side effects of investigational drug in~     healthy volunteers. See how quickly investigational drug enters the bloodstream, is~     distributed in the body, broken down and removed in healthy male and female volunteers. See~     if your body makes antibodies to this investigational drug (how your immune system~     responds).~   "
135308|NCT01283919|"~     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release~     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets~     (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting~     conditions.~   "
135631|NCT01279590|"~     The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with~     treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.~      To assess the safety and tolerability of PPD10558 compared to atorvastatin in patients~     previously intolerant to statins.~   "
135292|NCT01284023|"~     Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the~     pressure inside the leg due to swelling exceeds the body's ability to provide blood to the~     muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the~     condition can result in devastating consequences including complete loss of function of the~     lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion~     monitors are a non-invasive means of continuously monitoring the amount of oxygen in the~     tissues of an injured extremity. The device utilizes harmless red light to detect the~     proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The~     purpose of this study will be to launch the first stages of validation of this device as a~     diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.~   "
135293|NCT01284010|"~     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from~     patients with acute lymphoblastic leukemia.~   "
135294|NCT01283997|"~     The goal of this clinical research study is to see if Minocin® (minocycline) can help to~     control nerve damage that causes numbness and tingling in the hands and feet (neuropathy) in~     patients receiving thalidomide and/or bortezomib.~   "
135295|NCT01283984|"~     AZD2115 Single Ascending Dose Study~   "
135296|NCT01283971|"~     This randomized, parallel-group study will assess the efficacy and safety of~     RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate~     (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already~     treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8~     mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks.~     All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly).~     The anticipated time on study treatment is 24 weeks.~   "
135297|NCT01282983|"~     Dietary fiber (commonly called bulk or roughage) is the edible nondigestible component of~     carbohydrate and lignin naturally found in plant food; however, bacteria in the lower gut~     may metabolize part of it. Epidemiological studies have found that fiber intake in the~     population is below the suggested recommendations. The beneficial effects of the fibers in~     human health are recognized. The regular intake of dietary fiber has an important role in~     the intestinal function increasing the intestinal fecal and reducing the transit time along~     the intestine; collaborates with the LDL-cholesterol plasmatic reduction by increasing fecal~     excretion of cholesterol and bile acids, decreases postprandial glucose in healthy,~     diabetics and insulin resistant people, reduces the risk for developing certain cancers,~     promotes satiety, helps with weight loss, and exerts immunomodulatory effect. However, fiber~     intake may be associated with adverse effects such as flatulence, bloating, cramps, and~     daily consumption of orange juice to bring digestive problems associated with acidity and~     heartburn, epigastric burning. Then it becomes of interest to study the tolerance of a new~     orange juice product fortified with mixed fibers (fructooligosaccharides, resistant dextrin,~     polydextrose and lactulose).~   "
135298|NCT01282970|"~     The objective of this study is to investigate safety, tolerability, pharmacokinetics and~     pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days~   "
135299|NCT01282957|"~     The primary objective of the study is to assess the effect of financial incentives on the~     use of home health monitoring devices among high-risk patients. In addition, there are three~     secondary objectives: (1) obtain preliminary evidence regarding whether the monetary value~     of incentives has a differential effect on the use of home health monitoring devices; (2)~     identify potential barriers that prohibit regular use of home-based health devices using~     qualitative data; and (3) assess the usability of a newly developed web portal and its~     feasibility for future randomized clinical trials aimed at changing health-related~     behaviors.~   "
135300|NCT01282944|"~     The goal of this pilot randomized controlled trial is to evaluate whether financial~     incentives and peer networks delivered through a novel computer platform utilizing a digital~     pedometer-internet interface can effectively encourage sustained increases in walking among~     older adults.~   "
135301|NCT01282931|"~     The goal of the study is to understand the meaning of progression-free survival for women~     with metastatic breast cancer and to use this understanding to create and distribute a new~     questionnaire to assess the effect progression has on a woman's functioning and well-being.~   "
135302|NCT01282918|"~     The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without~     intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF~     testing regarding the efficacy of the first ICD shock for the treatment of true spontaneous~     ventricular tachyarrhythmias.~   "
135303|NCT01282905|"~     The purpose of this study is to evaluate the relation between sulphide detoxification and~     butyrate metabolism at the level of gene expression and enzyme activity in ulcerative~     colitis patients and healthy controls.~   "
135304|NCT01282892|"~     Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a~     condition carrying a high risk of coronary artery disease. The independent role of Visceral~     Fat in cardiovascular risk remains unclear.~      Patients with excess of visceral fat and NAFLD patients will have higher prevalence of~     coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting~     that the presence of visceral fat and/or fatty liver will be considered an important~     condition to optimize the cardiovascular risk stratification~   "
135305|NCT01283958|"~     Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the~     evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted~     therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess~     the effects of inhaled iloprost on patients with Eisenmenger's syndrome.~   "
135306|NCT01283945|"~     Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two~     most relevant players in tumor angiogenesis and simultaneously targeting proliferation in~     FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2,~     3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at~     well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make~     it an attractive candidate for development in humans.~      This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary~     objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally,~     once daily, on a continuous schedule over the initial 28-day cycle.~      Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics~     and antitumour activity of Lucitanib, given as a single agent to adult patients with~     advanced solid tumours.~      The study consists of two phases, a dose escalation phase followed by a dose-expansion phase~     at the identified Recommended Dose (RD). Eligible patients have histologically or~     cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory~     to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or~     11q 12-14 amplification, assessed by FISH or CGH array, or sensitive to antiangiogenic~     treatment. These latter are defined as patients who have relapsed after having experienced~     stable disease (lasting at least six months) or partial response with prior treatment with~     an approved antiangiogenic regimen or patients with tumour types known to be potentially~     responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic~     agents were approved and/or available for that specific condition (e.g thyroid cancer,~     thymic carcinoma).~      Serial safety assessments, including evaluation of symptoms, physical examination and blood~     and urine laboratory analyses are performed throughout the study. Cardiac functions and~     blood pressure are monitored in consultation with a cardiologist. PK parameters are~     determined on plasma samples collected during the first 4-week cycle and analyzed using a~     validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the~     effects of E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of~     angiogenesis biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and~     PIGF(by ELISA) and circulating endothelial and progenitors cells (CEC and CEP). Tumor~     response is based on imaging according to RECIST; circulating tumor cells (CTC) are measured~     by the immunomagnetic CellSearch method.~      In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be~     formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30,~     power 0,80.~   "
135307|NCT01283932|"~     To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release~     tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets~     (Wyeth Laboratories, USA) in 52 (+ 6 standby) healthy, adult, human subjects under fasting~     conditions.~   "
135632|NCT01279577|"~     This study will run in centers in Germany, Denmark, Austria, Czech Republic, and~     Switzerland, only.~      This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO~     suspension vs. placebo for the induction of remission in Crohn's disease.~   "
135309|NCT01283906|"~     This study is a randomized, double-blind, sham-controlled, two-arm study conducted in~     subjects receiving chemoradiation therapy for the treatment of head and neck cancer to~     assess the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the~     symptoms of oral mucositis. The study includes a treatment period of approximately 7 weeks~     depending on the subject's prescribed radiation plan.~      MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system~     (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently~     distributed within the mouth, the mucoadhesive formulation results in the formation of a~     protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for~     the treatment of head and neck cancer are at high risk of developing oral mucositis as an~     adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence~     and severity of mucositis in head and neck cancer patients undergoing radiation therapy when~     compared with data from historical control groups. The purpose of this study is to perform a~     direct comparison of the effectiveness of MuGard with a control group.~   "
135310|NCT01283893|"~     Gastric cancer is one of the most common cancers in Korea. Having achieved excellent~     long-term survival for early gastric cancer patients, there is a growing interest in~     improving the quality of life of these patients without compromising their prognosis.~     Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with~     superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is~     being performed for patients with locally advanced gastric cancer; the completeness of the~     D2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized~     procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to~     the open approach, quality control of D2 lymphadenectomy procedure is necessary.~   "
135311|NCT01283880|"~     Metabolic acidosis is a common complication in incident renal transplant recipients.~     Protracted acidosis may be associated with osteoporosis, inflammation, negative protein~     balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary~     data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of~     incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the~     prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients~     and to identify clinical correlates and (2) to find associations between RTA,~     nephrolithiasis and nephrocalcinosis~   "
135312|NCT01283867|"~     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's~     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in~     healthy, adult, human male subjects under non-fasting conditions and to assess the~     bioequivalence.~   "
135313|NCT01283854|"~     Gestational diabetes mellitus (GDM) is one of the most common medical complications of~     pregnancy and has serious health implications for both the pregnant woman and her child. In~     particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes~     and metabolic syndrome, perpetuating serious health consequences in subsequent generations.~      Although regular exercise offers numerous benefits for both the mother and her child, its~     effectiveness in preventing GDM remains to be established. It has been recently shown that~     regular supervised home-based exercise may attenuate the decline in glucose tolerance in~     obese pregnant women. This study aims to conduct a single-centred, multi-sited,~     single-blinded randomised controlled trial examining the effect of 14 weeks of supervised~     home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM,~     along with other aspects of maternal and fetal wellbeing.~      Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n =~     100) or a control group (n = 100). The exercise intervention will involve three 60-minute~     home-based, supervised exercise sessions each week. This type of program overcomes many of~     the barriers to exercise in this population including transportation, child care issues and~     embarrassment associated with exercising in a public venue. The investigators have already~     shown this program to be both feasible and warmly accepted by obese pregnant women.~   "
135314|NCT01283841|"~     To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's~     test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in~     healthy, adult, human male subjects under fasting conditions and to assess the~     bioequivalence.~   "
135315|NCT01283828|"~     This primary goals of this study are to: estimate the prevalence of Clostridium sordellii~     and Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive~     age; estimate duration of carriage of the two clostridium species; and estimate the~     incidence of carriage at 2 weeks after a negative test.~   "
135316|NCT01283815|"~     According to retrospective studies the conservative management of periappendicular abscess~     is associated with decreased complication and re-operation rate compared with open~     appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage~     is not possible because of anatomical position of the abscess and surgical treatment is~     needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable~     for the first-line treatment in patients with periappendicular abscess.~      The hypothesis of the study is that laparoscopic management of periappendicular abscess is~     suitable for the first-line treatment and it does not increase time of hospitalization or~     complication rate compared with conservative management.~   "
135317|NCT01283802|"~     Liver surgery should be considered an echo-guided procedure to guarantee conservative but~     radical resections. The investigators describe a further application of intraoperative~     ultrasonography (IOUS) for studying the biliary tree during liver surgery with no need for~     formal cholangiography.~   "
135318|NCT01283789|"~     By doing this study, researchers hope to learn the effectiveness of the combination of~     Lapatinib and RAD-001 for treating patients who have progressed on previous therapies.~   "
135319|NCT01283776|"~     A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as~     single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in~     patients with multiple myeloma or lymphoma and to describe the influence of the modified~     immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution~     and chimerism.~   "
135320|NCT01283763|"~     The purpose of this study is to investigate the non-inferiority of a topical Imiquimod~     therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e.~     conization A randomized, controlled, non-inferiority AGO-Austria trial~   "
135321|NCT01283750|"~     Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish~     Community Federation of Baltimore, this project seeks to develop effective ways to deliver~     dementia care to older adults with memory disorders who live in the community. MIND at Home~     is an 18 month intervention research study whose goals are two-fold: To partner with~     community organizations to help proactively identify older adults in the Baltimore community~     who may need help related to memory disorders; To find out if providing person-centered,~     coordinated care will help older adults with memory disorders remain at home longer, as well~     other possible benefits. The investigators hypothesize that individuals with memory~     disorders that receive person-centered, coordinated care will have fewer unmet~     dementia-related needs, improved quality of life and function, fewer behavioral and~     depressive symptoms, and will be able to remain in their homes longer compared to~     individuals who receive augmented usual care.~   "
135322|NCT01283737|"~     This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.~      The investigators hypothesize that function, pain, type and quality of cartilage in adult~     patients with osteochondritis dissecans of the knee will be better in the DBX group compared~     to the mosaicplasty group.~   "
135323|NCT01283724|"~     A clinical trial which was designed to demonstrate the safety and efficacy of Visanne~     (approved in endometriosis for adults) in the adolescent population.~   "
135324|NCT01283711|"~     Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among~     female and male patients of all ages. Different technologies are presently available to~     rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL),~     however radiofrequency has emerged as the most effective and versatile modality for the~     broadest range of body and facial treatments, including non-invasive wrinkle treatment.~      The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is~     based on three or more electrodes designed to deliver RF current focused into the skin, thus~     generating heat in the dermal layer. Selective and focused electro-heating of the skin is~     intended to stimulate collagen remodeling in the dermal layer resulting in non invasive~     wrinkle treatment.~      The apollo™ system is intended for use in dermatologic and general surgical procedures for~     non invasive treatment of facial wrinkles and rhytides. This study was designed in order to~     evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides~     treatments.~   "
135325|NCT01283698|"~     The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004~     in a Psoriasis Plaque Test (PPT)~   "
135326|NCT01283685|"~     Regular exercise can help patients with the lung disease, chronic obstructive pulmonary~     disease (COPD). But COPD patients have a hard time with training because of their breathing.~     To improve their program they can train with one leg at a time. Another way is to make their~     exercise easier by breathing helium. Putting two methods, one-legged and helium, together~     may improve their program even more. This project is planned to assess whether breathing~     helium improves their one-legged exercise endurance. If it does, then there may be a reason~     for combining one-legged exercise with breathing helium as part of their respiratory~     rehabilitation program. The aim of this study is to determine whether breathing~     helium-hyperoxia enables a further increase in the constant power endurance time during~     one-legged exercise in ventilatory limited subjects with COPD. The null hypothesis is that~     patients will have sufficient peripheral muscle limitation that ventilatory unloading using~     helium-hyperoxia will be of no additional benefit to exercise tolerance. The investigators~     hypothesize that patients with COPD are so ventilatory limited relative to their peripheral~     muscles that helium-hyperoxia will improve their exercise endurance.~   "
135327|NCT01283672|"~     The objectives of this study are the following: 1) to determine the acute effect of whole~     grain barley on risk factors of cardiovascular disease compared to a diet low in whole~     grain, and 2) to compare the effects of whole grain barley to those of whole grain oats to~     determine if the response to these two grains is similar.~   "
135328|NCT01283659|"~     Background: The prevalence of heart failure (HF) is rapidly rising in industrialized and~     developing countries. Though invasive coronary angiography (ICA) remains the gold standard~     for anatomical assessment of coronary arteries and luminal stenoses in these patients,~     alternatives have been sought. Computed tomographic coronary angiography (CTA) has emerged~     as an accurate non-invasive diagnostic tool for CAD and has been demonstrated to have~     prognostic value. Whether or not CTA can be used in patients with HF for diagnosis and to~     guide patient investigations and management is unknown. Acknowledging the aging population~     in industrialized counties, the increasing burden of healthcare and growing prevalence of~     HF, there is a need to identify non-invasive diagnostic tests that are cost-effective,~     readily available, safe and of sufficient accuracy to risk stratify patients and guide~     investigations and management.~      Methods: The proposed randomized controlled trial (RCT) will evaluate the clinical utility~     of computed tomographic coronary angiography (CTA) and investigate its potential benefit on~     resource utilization and health economics in patients with progressive or newly diagnosed~     heart failure (HF) of unknown etiology (i.e. ischemic versus non- ischemic) or in whom the~     definition of coronary anatomy is required for diagnosis and management. The experimental~     algorithm will be compared to invasive coronary angiography (ICA)~      Analysis of composite clinical events and major adverse cardiac events will be performed to~     determine the impact of these strategies upon patient outcomes. Accuracy of CTA in detection~     of coronary anatomy and obstruction will be assessed in patients undergoing ICA. It is~     expected that CTA will be a more cost-effective strategy for diagnosis; yielding similar~     outcomes with fewer procedural risks and improved resource utilization.~   "
135329|NCT01283646|"~     Lack of appetite is one of the most common reasons for visits to pediatric clinics.The~     symptoms usually manifest after weaning when they are introduced into the diet of infant~     foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and~     B and also vitamins complex.~   "
135330|NCT01283633|"~     In recent years, robotic devices are becoming more and more common in medical practice. Such~     devices provide an effective way to communicate within a clinical setting, but recent~     studies have shown far more diverse uses for these robots, ranging from training future~     surgeons to diagnoses of patients. In the investigators study, the investigators would like~     to investigate whether it is effective to employ robotic devices in the administration of~     neurostimulation treatment. It is the investigators hypothesis that the introduction of~     robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation~     treatment protocol. In addition, the investigators also predict a high satisfaction rating~     from all participants involved in conditions involving the robot.~   "
135363|NCT01283204|"~     This study is to evaluate the antitumor activity (i.e. progression free survival, overall~     survival, response rate, etc), safety and quality of life in patient with recurrent or~     metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based~     chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer~     agents according to the results of pharmacogenetic study.~   "
135364|NCT01283191|"~     While physical activity has been associated with decreased craving and increased abstinence~     rates in smokers, few published studies have examined the effects of exercise on recovery~     from other drugs such as cocaine. One factor that has impeded such research has been low~     levels of patient compliance with exercise protocols. One robust strategy for promoting and~     maintaining behavior change is contingency management or Behavioral Incentives (BI). BI~     delivers incentives (prizes, vouchers) contingent upon target behaviors such as cocaine~     abstinence (Higgins et al., 1994); treatment attendance (Svikis et al., 1997) and other~     pro-social behaviors (Kirby et al., 1998). While the literature is replete with studies~     demonstrating the benefit of BI compared to control conditions (Stitzer & Petry, 2006), the~     translation of BI methods from research to clinical practice has met with some resistance.~     Contributing factors include philosophical differences (e.g., counselors feel extrinsic~     reinforcement undermines recovery) and practical barriers (e.g., monetary costs of~     incentives may be prohibitive). The latter concern was addressed by Petry (2005) who~     developed the fish bowl method, which uses escalating variable ratio procedures to reduce~     per patient costs of BI with similar effect sizes.~      As a Stage 1 behavioral therapies development grant (Rounsaville et al., 2001), the primary~     aim of this research is to pilot test a BI intervention designed to promote regular physical~     activity in a sample of women receiving inpatient treatment for SUDs. The target behavior,~     physical activity, will be objectively defined as 30 minutes of observed treadmill walking~     at any intensity 3 days/week at Level 1, and 30 minutes of higher intensity physical~     activity that meets ACSM criteria for moderate exercise Level 2. Specifically, a pilot~     randomized clinical trial will compare rates of physical activity over a 6 week study period~     in a sample of N=50 women with Cocaine Dependence. All participants will complete baseline~     assessment, attend a 45-min Health and Fitness (HF) education group, followed by random~     assignment to either the experimental (BI) or control (C) groups, with equal daily access to~     on-site treadmills. Those randomized to BI, however, will also be eligible 3 days/week, to~     receive incentives for completing 30 minutes of treadmill walking.~      Incentives will be dispensed using Petry Fish Bowl methods. Women assigned to the BI group~     will receive behavioral incentives (in the form of gift cards or prizes) for completing~     their scheduled exercise sessions (Level 1), and have the opportunity to earn bonus draws~     for meeting moderate intensity exercise criteria, as specified by ACSM (2007, revised)~     guidelines (Level 2). In Level 1, the number of tokens participants can draw from the gym~     bag (present study equivalent to fishbowl) at each visit will be linked to exercise~     session attendance, with consistent attendance resulting in greater number of draws. In~     Level 2, the number of tokens a participant can draw from the gym bag will be linked to the~     intensity of the participant's exercise. Specifically, beginning in Week 2 of the study,~     participants will be re-evaluated for exercise capability. Those who pass the safety screen~     will be encouraged to exercise at a higher intensity, and those who do not will be~     re-evaluated until they obtain safety clearance. Once cleared, if the participant meets~     criteria for moderate exercise during her scheduled session, then she will be allotted a~     bonus draw (Level 2) for meeting Level 2 criteria, in addition to the escalating number of~     draws she would received for scheduled exercise session completion (Level 1).~      Scheduled treadmill walking will be monitored and recorded for both BI and C group women.~     Follow-ups will occur at study midpoint and completion (3 and 6 weeks post-randomization,~     respectively), and at 4 weeks post-discharge. Assessments will focus on drug craving, mood,~     stress, motivation/self-efficacy, and physical health and well being. The investigators~     hypothesize that women in the BI group will complete more treadmill sessions and spend more~     time treadmill walking than those in the C group. As a Stage 1b therapy development RCT,~     study data will be used for effect size estimation in preparation for Stage 2 RCT. This~     dissertation proposal will provide benchmark data on the utility of BI for promoting~     physical activity. Further, it will promote exercise compliance, allowing scientists to~     better evaluate potential benefits of physical activity on treatment outcomes in women with~     SUDs.~   "
135331|NCT01283620|"~     The purpose of this study is to examine the effectiveness and feasibility of a modified~     constraint induced movement therapy (mCIMT) intervention on upper limb function in two~     groups of patients acutely post-stroke; 1) an experimental group that will participate in a~     10 week mCIMT intervention designed to improve upper limb function, in addition to usual~     care, and 2) a control group that will participate in a program of usual care consisting of~     a rehabilitation intervention for the affected upper limb that is dose-matched to the~     experimental group.~   "
135332|NCT01283607|"~     Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with~     a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has~     relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk~     profile has been identified and translated into a screening tool. Identification of women at~     risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT),~     which reduces more serious maladjustment and corresponding costs.~      Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in~     women ongoing IVF and having been screened at risk.~      Design: A single-centered randomised controlled trial comparing Digicoach (intervention)~     with standard care (control).~      Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following~     a woman's IVF course and covering in modules the main problems: depressed mood, anxiety,~     strong focus on child wish and acceptance.~      Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful~     IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3.~     productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical~     record audit and page view registrations.~      Process evaluation: Individual's use (e.g. module progress, completion rate), experiences,~     (e.g. satisfaction and usability) and potential barriers for implementation are evaluated.~      Economic evaluation: studied during the Digicoach exposures from a societal perspective.~     Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both~     study groups.~      Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates~     (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.~   "
135333|NCT01283594|"~     The purpose of this research study is to test the effect of SYN115 compared to placebo (a~     sugar pill that looks like SYN115 but does not include active drug) on movement during the~     on and off states as well as other symptoms that some patients with Parkinson's disease~     experience. This study will also look at whether or not patients with Parkinson's disease~     experience side-effects with SYN115.~   "
135334|NCT01283581|"~     The purpose of this study is to compare clinical response to the measurement techniques of~     several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial~     Skin and Skin Structure Infections) clinical trials~   "
135335|NCT01283568|"~     GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant~     extracts. The investigators will try the mixture and see if the vasomotor symptoms will~     disappear. The investigators expect that together all symptoms will be covered better than~     Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting~     point, 30 days and 180 days).~   "
135336|NCT01283555|"~     The primary objective of this study is to compare the effect of two vaginal applicators,~     delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the~     external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily~     use.~      The secondary objectives are to:~        1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator~          and pre-filled applicator with the candidate microbicide, Tenofovir.~        2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.~   "
135337|NCT01283542|"~     This study will assess pasireotide LAR efficacy on patients with non-functioning pituitary~     adenomas concerning tumor growth.~   "
135338|NCT01283529|"~     Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement~     of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed~     also for use in children, but there is a lack of documentation of reference values in~     children not suffering from a critical illness. The goal of this study is to establish such~     values.~   "
135339|NCT01283516|"~     This study will assess the safety and efficacy of LDK378 in adult patients with genetic~     abnormalities in anaplastic lymphoma kinase (ALK)~   "
135340|NCT01283503|"~     In this study, BKM120 will be administered to adult patients with advanced solid tumors~     whose disease has progressed despite standard therapy or for whom no standard therapy~     exists. The trial will confirm the safety and tolerability and determine the maximum~     tolerated dose (MTD) of BKM120 in Japanese patients.~   "
135341|NCT01283490|"~     The Dental Anesthesia Sonophoresis Device (DASD) is a novel device that is intended to~     reduce the discomfort associated with puncturing the oral mucosa. DASD is a portable,~     battery-powered device that simultaneously generates ultrasonic energy and sonic vibration~     in a small applicator head that can easily reach and adapt to injection sites in the oral~     cavity. The ultrasonic energy provides a sonophoretic effect on the oral mucosa, generating~     micro channels through the lipids between the keratinized cells that make up the stratum~     corneum. Once the benzocaine has permeated the stratum corneum, it is quickly absorbed into~     the soft tissue desensitizing the area and reducing the perception of pain caused by the~     trauma of puncturing soft tissue. Methods: A split-mouth model using 50 healthy subjects~     from the ages of 18 to 50 will undergo needle puncture of the maxillary mucobuccal fold at~     the canine eminence. Prior to the injection there will be randomized application of 20%~     Benzocaine with a device which is a modified battery operated tooth brush that in appearance~     and sound is similar to the DASD which only produces sonic vibration which will be known as~     (SV) or 20% benzocaine with application of the DASD device, that produces ultrasonic as well~     as sonic vibration. Subjects will rate their pain according to the Visual Analog Scale~     (VAS).The purpose of this study is to evaluate whether sonophoresis applied using the DASD~     will eliminate the pain associated with intraoral injections within one minute of~     application.~      Null Hypothesis (Ho): There is no difference in the perception of pain when the DASD is used~     compared to topical anesthetic applied with sonic vibration.~      The Alternative Hypothesis (Ha): There is a difference in pain perception when the DASD is~     used for application of topical anesthetic compared to topical anesthetic applied with sonic~     vibration.~   "
135342|NCT01283477|"~     Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects~     such as itch (pruritis) and nausea & vomiting are common and have been shown to be the most~     common cause for dissatisfaction. The incidence of pruritis is 74% even with current~     available medications. Acupuncture has been shown to be effective for morphine related side~     effects but has not been evaluated for prophylaxis of itch in pregnant population.~      PRIMARY OBJECTIVE:~      Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section~     under spinal with intrathecal morphine~   "
135343|NCT01283464|"~     The purpose of this study is to assess the comparative efficacy of retinol 1.0% and~     tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of~     moderate to severe photodamage. Our hypothesis is that both products will be of comparable~     benefit.~   "
135379|NCT01282996|"~     The purpose of this study is to compare the influence of a lung protective ventilation with~     conventional ventilation on postoperative complications following major abdominal surgery.~   "
135344|NCT01283451|"~     Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring~     tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS).~     Placement of these sensor pads on the surface of the skin must be such that light penetrates~     the intended compartment without inadvertently obtaining measurements of an adjacent~     compartment. The objective of this study is to examine whether the NIRS measurements of each~     compartment truly represent the tissue perfusion of the intended compartment, as indicated~     by the predictable decrease in muscle oxygenation of a given compartment in response to~     muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the~     stimulated compartment will significantly decrease following muscle stimulation, indicating~     that the intended muscle compartment was successfully isolated. Additionally, the~     investigators hypothesize that NIRS values of unstimulated muscle compartments will not~     change from baseline.~   "
135345|NCT01283438|"~     A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction~     with limited discectomy, compared to limited discectomy alone, with regard to preventing~     reherniation and the recurrence of pain or dysfunction.~   "
135346|NCT01283425|"~     The study is an open-label, randomized, two-period crossover study. Up to one hundred and~     twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm~     insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed~     Consent will be enrolled in the study. The aim of the study is to examine the safety of the~     InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events~     will be compared between two phases of the study : 3 months with the use of the device and 3~     months without the use of the device.~   "
135347|NCT01283412|"~     Postoperative agitation (hyperactive delirium) is common following major surgery(incidence~     was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate~     when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine~     is useful on reducing postoperative delirium. The hypothesis of present study:~     intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than~     placebo for reducing of early postoperative delirium and increase postoperative quality of~     recovery within 24 postoperative hours.~   "
135348|NCT01283399|"~     This observational study will assess the efficacy and safety of combination of rituximab~     (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA)~     who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in~     routine clinical practice. Data will be collected from participants for 12 months after the~     first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.~   "
135349|NCT01283386|"~     This multi-center, randomized study will compare the efficacy and safety of MabThera~     (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil~     in patients with previously untreated B-cell chronic lymphocytic leukemia and unfavourable~     somatic status. Patients will be randomized to receive Mabthera (375 mg/m2 intravenously~     [iv] Day 1 of Cycle 1, 500 mg/m2 iv Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 iv~     or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 iv or orally Days 1-3) or with~     chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study~     treatment is 24 weeks.~   "
135350|NCT01283373|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered~     as a single agent by intravenous (IV) infusion to patients with metastatic~     Castration-Resistant Prostate Cancer (CRPC).~   "
135351|NCT01283360|"~     After completing a screening evaluation, 280 eligible participants, including 40 sex~     workers, will be enrolled into Stage 1A of the study during which they will undergo a~     baseline medical evaluation for both history and presence of STIs and anorectal health~     pathologies or injuries, as well as a detailed Web-based baseline behavioral assessment. The~     first 140 eligible participants, including 20 sex workers, reporting at least one occasion~     of unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In~     Stage 1B participants will apply the universal placebo gel (HEC) rectally prior to each~     episode of RAI over a 3-month period, reporting each use via a phone reporting system; they~     will complete a Web-based questionnaire and take part in a video teleconference at the end~     of the 3 months. The first 24 eligible participants completing Stage 1B will be invited to~     enroll in Stage 2. The subset of sex workers who took part in Stages 1A and 1B will~     terminate participation at the end of 1B. Eligible participants will be randomized to~     receive either tenofovir 1% gel or HEC placebo gel as part of Stage 2, the Phase 1 safety~     study. Following a baseline visit, participants will return to the clinic, where a single~     dose of the study gel will be administered. Within approximately 30 minutes, rectal swab and~     rectal biopsy specimens will be obtained via anoscopy. After a one-week recovery period~     participants will return to the clinic for assessment. If no significant adverse events~     (AEs) are reported they will begin to self-administer once-daily outpatient doses of the~     study gel for 7 days, after which they will return to the clinic for evaluation and specimen~     collection.~   "
135352|NCT01283347|"~     The primary objective of this protocol is to analyze the sensitivity and specificity of~     18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality.~     Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and~     the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease~     severity.~   "
135353|NCT01283334|"~     The purpose of this study is to test the drug RAD001 in combination with other chemotherapy~     drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination~     before, it is not clear which dose will be best when used in combination.~      The investigators will test the safety of RAD001 in combination with Carboplatin and~     Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest~     dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin~     and Cetuximab will not be varied as both these drugs are considered to be part of the~     current standard of care for patients with your condition.~   "
135362|NCT01283217|"~     Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but~     it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase~     I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for~     advanced gastric cancer achieved response rates of 46~56% and a median survival time of~     14.0~14.3 months.~      Based upon this background, the aim of this study is to detect a significant increase in 3~     year DFS of disease for the test group (DS) relative to the Control group (SP).~   "
135354|NCT01283321|"~     Heart surgery involving valve replacement often involves the use of the heart-lung machine~     for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet~     transfusion has been the primary therapy to treat bleeding after this type of procedure.~     More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring)~     was shown to reduce bleeding and blood product use (plasma or platelets) after heart~     surgery. The objective of this trial is to demonstrate the clinical equivalency and economic~     utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative~     bleeding in patients in lieu of platelet transfusion.~      Purified fibrinogen concentrate has been approved by FDA, and it has been used for the~     treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary~     causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be~     associated with volume overload, bacterial/viral infection, immunological effects and excess~     blood clotting, purified fibrinogen has several advantages. First, it contains no liquid~     plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used~     to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white~     blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are~     rare. Although platelet transfusion is widely used after heart surgery, there has been no~     randomized study to endorse this practice. In this study, patients undergoing heart valve~     replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen~     concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if~     there is evidence of significant microvascular bleeding. Fifteen minutes after the initial~     treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will~     be treated with blood transfusion per institutional standard of care.~      The primary endpoints for this study are the hemostatic condition of the surgical field and~     24-hour total of blood product transfusion.~   "
135355|NCT01283308|"~     People from the Indian subcontinent are more likely to get diabetes, even at younger ages.~     The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized~     trial if a culturally specific, community-based lifestyle and metformin (for individuals who~     do not respond to lifestyle change alone) intervention for men and women living in Chennai,~     India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle~     interventions are programs that seek to prevent disease by promoting changes in health~     behaviors, improved diet, increased physical activity, and weight loss. The results of this~     program will be used to make policy and public health recommendations, which will result in~     broader diabetes prevention efforts. The research team hypothesizes that this program will~     result in improvements in health (diabetes prevention, weight loss, and improvements in~     other markers of chronic disease) for intervention participants compared to participants in~     the control arm of the study.~   "
135356|NCT01283295|"~     The purpose of this study to develop a well-characterized library of blood, biopsy tissue,~     and urine samples from transplant patients. Subjects without transplants will also be~     enrolled for comparison. Samples will be used to study the characteristics of patients~     undergoing transplantation that influence their response to transplant therapies and their~     reactions to drugs used in transplantation. This knowledge is important as it helps~     physicians design new drugs and tailor transplant therapies to the individual thereby~     reducing the side effects. In this study, people will be asked to donate blood, biopsy~     tissue and urine. Donation of these samples will not influence patients' treatments. These~     samples will be tested using a variety of biological tests to better understand how~     immunosuppressive drugs change the various components of the immune system. The tests will~     be for research only; no changes in an individual's treatment will be based on the results~     of tests performed in this study. If there is extra sample, the sample will be stored for~     use in other testing at a later date. The ultimate goal is find the right combination of~     medications for each individual patient while keeping their new organ working well. This~     study is a first step in that direction by perfecting tests used to characterize a patient's~     immune system~   "
135357|NCT01283282|"~     The investigators would like to investigate whether clopidogrel will help lower the level of~     harmful markers in patients with coronary artery disease, and at the same time will help~     increase the cells that are useful in repairing the damaged blood vessels. The investigators~     will give half of the patients clopidogrel and the other half a sugar pill, placebo, and~     check the levels of these markers and helpful cells in each group. At the same time the~     investigators will check how well these patient's blood vessels work using ultrasound~     imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the~     patient's blood vessels are. After 6 weeks of drug therapy, the patients will switch to the~     other drug and these same tests will be performed after an additional 6 weeks of therapy.~     The drug taken by the patient will not be known to the patient or the researchers. The~     patients will continue on their prescribed medical therapy during the duration of the 12~     week study.~   "
135358|NCT01283269|"~     Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD).~     The ability to identify MCI has led to hope that health prevention models might work in AD~     as they have in cancer and heart disease. Interventions which help sustain functioning in~     MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at~     maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these~     medications in MCI is controversial, and those with MCI are also often interested in other~     activities they can do to manage their memory loss.~      When an individual is noted to have memory difficulties or MCI, a recommendation is often~     given for the patient to begin taking notes/using a calendar to help with memory or do~     cognitively stimulating activities. However, there is currently little instruction about~     how/what specific activities one should do and how effective they may be. The overall goal~     of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal~     compensatory program for memory loss in MCI. Enrollment and retention data will be carefully~     investigated across 6 week and 10 day intervention groups. The investigators will compare~     participant adherence to the notebook training in the 6 week and 10 day versions of the~     intervention to the computer activity group. The investigators will also collect data on the~     clinical efficacy of the notebook and computer training to investigate if these~     interventions can sustain/improve functional level. Long term goals for this project also~     include delaying relocation for persons with MCI who may progress to dementia, thus not only~     improving the lives of these individuals, but also reducing health care expenditures.~      The investigators will recruit a total of 60 individuals with MCI and their 60 program~     partners across all three sites for this project. At least 16 of these pairs will be~     recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The~     investigators will randomly assign participants to the 6 week notebook or computer training~     or 10 day notebook or computer training. All participants will also receive patient~     education regarding MCI and cognitive health.~      Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually~     following the intervention. Outcome measures will provide a detailed, multi-modal assessment~     of participants' functional level, overall cognitive functioning, mood, and self-efficacy,~     as well as caregiver burden and mood.~   "
135359|NCT01283256|"~     The purpose of this study is to evaluate the safety and efficacy of zonisamide in the~     treatment of adult patients with partial, generalized or combined seizures.~   "
135360|NCT01283243|"~     This is a prospective cohort single center study for assessment of normal value of acoustic~     radiation force impulse elastography and fibroscan in HIV patients without abnormal liver~     function and chronic liver disease.~   "
135361|NCT01283230|"~     This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic~     radiation force impulse elastography in patients with chronic liver disease and healthy~     liver/kidney donors.~   "
136481|NCT01268540|"~     The purpose of this multi-center clinical trial is to determine the safety and efficacy of~     the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive~     astigmatism.~   "
135365|NCT01283178|"~     RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to~     the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans~     and treatment-planning systems may help in planning radiation therapy. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving radiation therapy~     together with cisplatin may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of~     intensity-modulated image guided adaptive radiation therapy when given together with~     cisplatin in treating patients with locally advanced head and neck squamous cell cancer~   "
135366|NCT01283165|"~     The main objective of the project was to determine the effect of integrated school based~     deworming and health education on prevalence and morbidity due to co-infection infection~     with schistosomiasis, STHs and malaria among primary school age children living in rural and~     farming areas in Zimbabwe~      There is need for regular school based de-worming and health education programs for the~     helminths-Plasmodium co-infections in primary schoolchildren living in rural and commercial~     farming areas in Zimbabwe~   "
135367|NCT01283152|"~     This study is being done to find out if the laxative polyethylene glycol (also known as~     GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver~     disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In~     this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more~     effective than lactulose on neurocognition (memory and thinking skills) and determine if it~     decreases the hospital stay.~   "
135368|NCT01283139|"~     To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with~     moderately to severely active Systemic Lupus Erythematosus (SLE).~   "
135369|NCT01283126|"~     The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy~     individuals and how well changes in (interstitial) tissue glucose levels correlate with~     changes in cognitive function as compared to blood glucose levels.~   "
135370|NCT01283113|"~     The main aim of this study is to compare 2 different measurements of visceral fat that can~     be easily used in clinical practice (waist circumference versus bioelectric impedance) in~     relation to known risk factors of coronary artery disease in a large cohort of patients with~     type 2 diabetes and with a BMI range between 20-45 kg/m2~   "
135371|NCT01283100|"~     This is a single-center, open-label, three-period, fixed-sequence cross over study in~     healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to~     provide data from 12 evaluable subjects. Subjects will have a screening visit within 30 days~     prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14~     days after the last dose of study drug. There will be a washout period between Period 1 and~     Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will be the day~     after Day 5 of Period 2.~   "
135372|NCT01283087|"~     The purpose of this study is to find out whether patients receiving spinal anesthesia~     containing lidocaine and sufentanil get transient neurological symptoms.~   "
135373|NCT01283074|"~     This observational, multi-center, open-label study will evaluate the prognostic factors of~     long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with~     HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.~   "
135374|NCT01283061|"~     The objective of this study was to compare the relative bioavailability of zafirlukast~     tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy,~     adult, human, subjects under fasting conditions and to monitor safety of subjects.~   "
135375|NCT01283048|"~     BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in~     laboratory experiments and information from those research studies suggests that this drug~     may help to slow the growth of renal cancer cells. In this research study, the investigators~     are testing the safety to BKM-120 at different dose levels. The investigators will also be~     studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of~     kidney cancer.~   "
135376|NCT01283035|"~     Akt inhibitor MK2206 is a drug that may stop cancer cells from growing by blocking a protein~     called protein kinase B (AKT) inside the cell. AKT interacts with other proteins in the cell~     that are part of the P13K/AKT pathway, a pathway that is know to play a role in the growth~     of cancer cells. Mutations in P13K or in AKT, or changes in another protein called~     phosphatase and tensin homolog (PTEN) in this pathway can lead it to become more active than~     is normal. This study investigates how effective MK-2206 is in treating ovarian, fallopian~     tube, or primary peritoneal cancer where there are mutations in P13K or AKT or low levels of~     PTEN.~   "
135377|NCT01283022|"~     The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for~     the MVI 200 in women requiring cervical ripening and induction of labor.~   "
135378|NCT01283009|"~     The goal of the study is to determine whether providing early treatment with a~     glucocorticoid drug, called methylprednisolone, will improve survival in critically ill~     patients with severe community-acquired pneumonia (CAP). Pneumonia develops when bacteria~     and other agents invade the lungs. The body's immune system creates a response to produce~     inflammation to kill the bacteria. A moderate amount of inflammation is beneficial. But, in~     patients sick enough to be admitted to the ICU, inflammation is frequently out of control.~     When the body cannot regulate inflammation and vital organs (brain, heart, lung, kidney,~     liver) may be damaged, contributing to death or residual organ damage for those who survive.~     Glucocorticoids help reduce inflammation. Recent studies have shown that when the body is~     unable to produce sufficient amounts of glucocorticoids, inflammation can get out of~     control. Under these circumstances, glucocorticoids given in small doses may help aid the~     body's ability to reduce inflammation and improve recovery. In a small preliminary trial,~     glucocorticoid treatment, in addition to standard antibiotic treatment, sped up recovery~     from pneumonia. It also decreased the length of hospital stay, and increased survival. This~     Cooperative Studies Program study will be the first large-scale, prospective, randomized~     clinical trial evaluating whether or not this treatment improves recovery.~      In this study, at each site, patients with severe CAP will be assigned to one of two~     treatment groups. One group will receive methylprednisolone and the other will receive a~     placebo (an inert substance that will look like the drug). The investigators have chosen a~     total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13~     days) to prevent relapse of inflammation and allow the body to recover its own ability to~     produce glucocorticoid. All patients will also receive standardized management of CAP in~     accordance with current practice guidelines. The study will take into consideration when~     assigning the treatment each participating site, and whether or not the patient requires~     mechanical ventilation at the time of assignment. Patients will be followed clinically for~     180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1)~     in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction~     syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and~     (2) posthospital discharge morbidity-mortality, including cardiovascular complications,~     functional and general health status in the first 180 days, rehospitalization, and mortality~     at 1 year. Serial blood samples will also be collected and stored for future translational~     research relating longitudinal inflammation markers to clinical outcomes.~      This study will advance knowledge on the relationship between inflammation and long-term~     outcome in severe CAP.~   "
135380|NCT01282879|"~     Antifungal prophylaxis should be used in patients being treated with glucocorticoids for~     graft-versus-host disease (GVHD) following allogeneic hematopoietic stem-cell~     transplantation (HSCT). Although fluconazole has been widely used as an antifungal~     prophylactic agent after allogeneic HSCT, fluconazole prophlaxis only shows a limited~     protective role against IFIs, is not effective against invasive aspergillosis. In addition,~     NCCN guideline of the prevention and treatment of cancer-related infections recommends~     antifungal prophylaxis in patients with significant GVHD until resolution of GVHD using~     Posaconazole, Voriconazole, Echinocandin, or Amphotericin B. However, under the National~     Health Insurance System, none of the drug can be given prophylactically except itraconazole~     oral solution against IFIs. Itraconazole oral solution shows excellent bioavailability and~     good efficacy against aspergillus and fluconazole resistant candida infection.Based on these~     findings, we will perform prospective multicenter study evaluating the efficacy, safety and~     long-term outcomes of itraconazole oral solution prophylaxis against IFIs in patients~     treated with systemic corticosteroids for GVHD after allogeneic HSCT.~   "
135381|NCT01282866|"~     The objective of this clinical study is to verify hair count reduction, associated~     comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed~     (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated~     that the larger treatment size of the HS handpiece will result in faster treatment of larger~     areas; and that the lower energy levels will result in greater comfort.~   "
135382|NCT01282853|"~     Rapid urease test (RUT) is the most commonly used biopsy-based method to diagnose~     Helicobacter pylori (Hp) infection because of its simple, rapid and accurate characters.~     However, its sensitivity was reported to decrease during ulcer bleeding recently. So it is~     an important issue to avoid a false negative test in these patients. Siddique et al reported~     that the sensitivity of RUT could be increased when the biopsy number increased from 1 to 4.~     Other studies demonstrated that additional biopsy from gastric body would increased the~     sensitivity of RUT in patients with ulcer bleeding. Therefore, we design this study to see~     if increased number of biopsy or different location of biopsy could increase sensitivity of~     RUT in patients with gastroduodenal ulcer bleeding.~      After receiving explanation and giving consent, these patients with gastric or duodenal~     ulcer bleeding diagnosed after endoscopic examination will be enrolled. Those who are~     unstable, have received antibiotic or continuous proton pump inhibitor treatment within 4~     weeks, or are contraindicated for endoscopic biopsy will be excluded. We will take 1 piece,~     4 pieces of biopsy samples from prepyloric antrum and 1 piece from gastric body with~     standard biopsy forceps from the patients after they agree for RUT test. Then, we put these~     samples into 3 separate RUT kits respectively. We use 13C-UBT as gold standard for diagnosis~     of Hp infection. It is scheduled: (1) if the condition of this patient is not suitable for~     breath test just after endoscopic examination, 13C-UBT will be performed within 2 days,(2)~     otherwise, it will be performed 1 hour after examination. We plan to enroll 100 patients for~     this study. We will apply McNamer's test to examine the difference of RUT sensitivity of~     different biopsy number. For the RUT sensitivity from different locations, we use kappa~     statistic method to analyze their consistency.~   "
135383|NCT01282840|"~     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the~     etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been~     reported to be strongly associated with OAB, but its use as a screening tool remains~     controversial. Besides, few studies reported patterns of sexual dysfunction in female~     patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to~     analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of~     between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic~     treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS~     patients.~   "
135384|NCT01282827|"~     Non-invasive brain stimulation can increase cortical excitability in the visual system, but~     it is not known if this is of clinical value. The investigators now assessed if repetitive,~     transcranial alternating current stimulation (rtACS) can improve visual field size in~     patients with optic nerve damage. The investigators hypothesized that rtACS would improve~     visual functions with the defective visual field sectors of the visual field (primary~     outcome measure).~   "
135385|NCT01282814|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the~     content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting~     conditions.~   "
135386|NCT01282801|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)~     administered as 1 x 150 mg extended-release capsule under fed conditions.~   "
135387|NCT01282788|"~     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer~     from stunting of linear growth by 12 months of age. Stunting presumably results from breast~     milk supplementation after 6 months of age with complementary foods (CF) that provide~     inadequate protein and micro-nutrients. Although supplementation with selected~     micro-nutrients may avoid certain deficiency states, CF with animal source foods may be~     necessary to avoid stunting. Meat is not readily available in many Central African~     countries. However caterpillars, which are locally available and abundant, are a common~     staple in adult diets and may be a suitable substitute for animal source proteins in CF. The~     investigators developed a cereal made from dried caterpillars that has a nutrient content~     that appears to be ideal for CF and demonstrated maternal and infant acceptability. This~     study will investigate the efficacy in prevention of stunting of growth resulting from~     inadequate complementary foods.~      A sub-study will evaluate the biologic effects of the caterpillar cereal to determine~     whether caterpillar cereal prevents iron deficiency anemia, reduces the incidence of~     neurodevelopmental impairment or infectious diseases.~   "
135388|NCT01282775|"~     CDC WAY to Health is a three year, group-randomized weight loss intervention study where~     approximately 1020 overweight/obese employees nested within 17 community colleges are~     randomly assigned to receive one of three promising, state-of-the-art, theory-linked~     interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment~     (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and~     intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted~     at 3, 6, and 12 months.~   "
135389|NCT01282762|"~     The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and~     Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in~     a cohort of chronic kidney disease (CKD) patients over time.~   "
135390|NCT01282749|"~     The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and~     scientifically-based, culturally acceptable weight loss program could be effectively~     translated into a faith-based program and subsequently delivered in the church to help~     African-American women lose weight.~   "
135391|NCT01282736|"~     The proposed study will employ a randomized design to evaluate the efficacy of two~     group-based guided self-help treatments: Integrative Response Therapy (IRT) and Cognitive~     Behavior Therapy Guided Self-Help, a treatment of known efficacy, in group-format (CBT-GSHg)~     in the treatment of Binge Eating Disorder (BED), and explore (1) moderators and mediators of~     treatment, (2) the relative cost-effectiveness of the two treatments, and (3) between group~     differences on secondary measures (e.g., eating disorder and general psychopathology).~   "
135392|NCT01282723|"~     This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG~     Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the~     performance of an Intrauterine Pressure Catheter device (IUPC) as the gold standard.~   "
135393|NCT01282710|"~     This measurement study was designed to evaluate the performance of SureCALL® EMG Labor~     Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of~     an Intrauterine Pressure Catheter device (IUPC) as the gold standard.~   "
135394|NCT01282697|"~     Therapeutic solutions to treat solid tumors that are resistant to conventional treatments~     are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors,~     sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha~     inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in~     the tumor and could, in some cases, stop its progression. This drug combination has already~     been tested in adult patients with refractory tumors and seems to give encouraging results~     with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known~     when these drugs are administered separately and in a context different from that of~     refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to~     determine the maximum dose at which these two molecules may be administered and to assess~     the safety of this new combination of drugs.~   "
135395|NCT01282684|"~     The purpose of this study is to study the safety and tolerability of a single dose of~     PLX5622 in healthy, adult human volunteers. This will be the first time PLX5622 has been~     taken by humans.~   "
135396|NCT01282671|"~     Hypothesis: Deep breathing exercises performed during the first two months after cardiac~     surgery, will improve pulmonary function and patient-perceived quality of recovery.~      Specific aim: To evaluate the effectiveness of breathing exercises performed with a~     mechanical device for positive expiratory pressure during the first two months after cardiac~     surgery compared to a control group performing no breathing exercises.~      Design: A prospective, randomized, controlled two-center study.~   "
135397|NCT01282658|"~     Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4~     key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase,~     carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of~     those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this~     study is to figure out the correlation between the genetic polymorphism and the drug~     response.~   "
135398|NCT01282645|"~     The primary objective of this retrospective study is to evaluate the percentage of patients~     with device related adverse events (infection, rejection, dislocation, fracture of the~     implant) in the first 24 months after implantation.~   "
135399|NCT01282632|"~     Atypical neuroleptics may have antidepressant qualities in bipolar depression and in~     unipolar depression. Some data support the use of both Risperidone and Olanzapine, but there~     are no direct comparisons of their relative efficacy and tolerability in treatment resistant~     depression. The current study was designed as a pilot study to examine efficacy and~     tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor~     (SSRI) in depression.~   "
135400|NCT01282619|"~     The main purpose of this study is to evaluate the safety and efficacy of Huperzine A~     sustained release tablets in patients with mild to moderate Alzheimer's Disease.~   "
135401|NCT01282606|"~     The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation~     patients.~   "
135402|NCT01282593|"~     Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore~     its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).~   "
135403|NCT01282580|"~     Research studies show that the type of fat in the diet may affect breast cancer risk. Fish~     oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow~     down the growth and development of breast cancer cells in laboratory studies of mice and~     breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer~     development in humans has not been adequately studied. Eating fish or taking fish oil may~     increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer~     development.~      Persons in this study with do one of the following: (1) take two capsules daily of omega 3~     fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a~     total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured~     by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.~      This study is supported by funding from the National Fisheries Institute, Food Innovation~     Center of The Ohio State University, and The Ohio State University Comprehensive Cancer~     Center.~   "
135404|NCT01282567|"~     The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes~     is focused on the evaluation of an original control algorithm that computes appropriate~     subcutaneous insulin infusion in response to continuous glucose measurements The results~     during a 24-hour closed-loop period will be compared with those of the open-loop. The~     implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a~     preliminary a phase of identification of the parameters of the model (insulin~     pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e.~     a personalized adjustment of the damping parameters of EDS.~      The present study aims to formalize this procedure of identification/optimization of the~     parameters of the model and controller EDS. They will be determined in type -1 diabetic~     patients using insulin therapy and under conditions free from disturbances such as those~     generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will~     determine this procedure: blood glucose, insulin concentration and insulin doses.~   "
135650|NCT01279343|"~     The purpose of this study is to compare the efficacy of the combination of the supracervical~     foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We~     hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter~     induction to delivery time.~   "
135405|NCT01282554|"~     Sport improves quality of life and health, decreasing cardiovascular risks and increasing~     effort tolerance. Chronic renal failure (CRF) induces many clinical and biological~     complications leading to less effort tolerance (strength and endurance). Renal failure~     patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA),~     diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions.~     Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order~     to counteract this, sport should be encourage in this specific hemodialysis population.~      The aim of this study is to evaluate electrostimulation program during dialysis sessions for~     3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).~      Secondary aims will be evaluated:~        -  Muscular strength and quadriceps diameter~        -  Equilibrium~        -  Quality of life.~        -  Strength developed during maximal exercise test in a subgroup (patient undergoing~          dialysis in Rennes center, about 40% of the total population)~        -  Nutritional intakes (quantitative and qualitative evaluation)~   "
135406|NCT01282541|"~     Epiphora or excessive tearing is a significant disability for many affected patients~     diminishing their quality of life. There is a growing consensus that injection of Botulinum~     Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation~     secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help~     to reduce normal tear production in patients with epiphora from anatomic or functional~     outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral~     lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes~     have been successful in symptom relief with minimal complications. However, the~     effectiveness of transconjunctival versus transcutaneous injections has not been~     systematically compared. Also, whether the incidence of side effects is related to the~     dosage, concentration, or location of injection is unknown and has also not been~     systematically studied. The investigators plan to conduct a randomized clinical trial in~     patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the~     transconjunctival delivery route (the most common route described in the literature). The~     investigators will also compare the side effect profile of each delivery route.~   "
135407|NCT01282528|"~     To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables~     in relation to disease activity and radiographic outcome in patients with RA who start~     treatment with Remicade at 24 weeks.~   "
135408|NCT01282515|"~     To compare the effect and side effects of photodynamic treatment and traditional topical~     steroid treatment in female genital erosive lichen planus~   "
135409|NCT01282502|"~     This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug~     call 5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type~     of kinase inhibitor which works by blocking proteins associated with cancer cell growth.~     Previous studies also suggest that midostaurin may help increase the effectiveness of~     radiation therapy. In this research we are looking for the highest dose of midostaurin that~     can be given safely in combination with standard chemoradiation.~   "
135410|NCT01282489|"~     A basic requirement for every therapeutic procedure is that there be an objective and~     validated method to assess the benefit of the treatment for the patient. Currently, there is~     no acceptable procedure to quantify the benefit obtained from visual prostheses.~      The goal of the proposed research is to evaluate visual tasks and tests that will be given~     to a very large number of volunteers with normal vision who will be using a novel virtual~     prosthesis simulator. This device will simulate the realistic visual information that a~     visual implant can provide and will be used to measure implants in current clinical trials.~   "
135411|NCT01282476|"~     Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by~     blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory~     studies. However, it is not known if it will show the same activity in humans. Panobinostat~     has been given to participants with various types of cancers, including DLBCL, in previous~     research studies. In this study panobinostat will be given with the the antibody rituximab,~     which is FDA approved to be given with chemotherapy in DLBCL.~   "
135412|NCT01282463|"~     This multicenter trial will enroll participants with metastatic transitional cell carcinoma~     of the bladder, urethra, ureter, or renal pelvis who have had disease progression on~     first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3~     treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and IMC-18F1.~   "
135413|NCT01282450|"~     In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a~     group of patients with less than 5 distant metastases may experience long-term survival when~     treated radically to all macroscopic cancer sites. Thus has mostly been established for~     individuals with so-called solitary brain metastases and to a lesser extend in solitary~     adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In~     a prospective survey in the region of the Integral Cancercentre (IKL), we could identify on~     a yearly base 30 patients with NSCLC who could theoretically be amendable for radical~     treatment of all oligo-metastatic locations. We therefore want to perform a prospective~     study in which patients with less than 4 oligo-metastatic sites from a primary NSCLC will be~     treated radically with the aim to improve long-term survival. As many discussion points~     remain, even after thorough discussions with chest physicians, pulmonary surgeons and~     colleagues from diagnostic disciplines, we decided to go for a pragmatic approach, implying~     that all macroscopic disease sites should be treated radically, being defined as surgery~     with a R0 resection or in case of an unforeseen R1 resection, followed by radiotherapy, or~     radiotherapy to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same~     patient, one metastatic site may be treated with surgery and another with radical~     radiotherapy. Systemic treatment was not made mandatory, because it was felt that it's role~     is unclear in patients with early stage local cancer and with oligo-metastatic disease.~   "
135414|NCT01282437|"~     For patients with stage III non-small cell lung cancer, which is radically treated, we will~     investigate whether prophylactic cranial irradiation (PCI) should become standard of care to~     prevent brain metastases.~   "
135508|NCT01281202|"~     The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent~     subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use~     of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher~     than seen in subjects treated with placebo in addition to counseling.~   "
135415|NCT01282424|"~     The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients~     with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to~     rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to~     assess the overall response rate.~      Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg~     taken twice per day. Treatment with idelalisib can continue in compliant patients as long as~     the study is still ongoing and the patients appear to be benefiting from treatment with~     acceptable safety.~   "
135416|NCT01282411|"~     Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal~     vein occlusion. It remains unclear how quickly the drug works and for how long as the~     initial studies did not have frequent anatomic monitoring. This study will utilize frequent~     Spectral domain OCT imaging to better understand the onset of treatment effectiveness and~     duration of action on the anatomic thickness of the retina, in addition to distinguishing~     structural abnormalities of responders from non-responders.~   "
135417|NCT01282398|"~     The purpose of this study is to determine whether simvastatin is effective in the prevention~     of progression of porta hypertension in compensated cirrhosis patients.~   "
135418|NCT01282385|"~     In the genesis and maintenance of PH associated with liver cirrhosis are two mechanisms that~     act synergistically. The first is an increase in hepatic vascular resistance, due in part to~     the disruption of liver structure inherent cirrhosis, and increased hepatic vascular tone is~     caused by the contraction of perivascular smooth muscle cells, myofibroblasts and hepatic~     stellate cells, which represents about 30% of global intrahepatic resistance and is believed~     to be due to the production Defective nitric oxide (NO). The second mechanism, which~     maintains and exacerbates HTP, is an increase of splanchnic blood flow caused by increased~     NO and other vasodilators at this level~      In this regard, we believe that in patients with compensated liver cirrhosis, with portal~     pressure gradient> 10 mmHg, both acute responders betablockers test as non-responders, the~     association of antifibrotic drugs and / or vasodilators, chronic liver selective May be~     beneficial in the control of portal hypertension~   "
135419|NCT01282372|"~     Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated~     an improvement in work productivity in participants with rheumatic diseases: rheumatoid~     arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was~     available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA,~     and AS) and no data was available for the effect of adalimumab treatment on work~     productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational~     study was conducted to evaluate the effect of treatment with adalimumab on work productivity~     and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA,~     PsA, and AS).~   "
135420|NCT01282359|"~     The asthma clinical practice guidelines categorize with the highest evidence level the~     effectiveness of educational programs. However, health care professionals not regularly~     applied it. This may contribute to inadequate control of the disease. Consequently, their~     designs and implementation strategies should be reviewed.~      Hypothesis. An asthma educational program based on a limited intervention, managed by~     professionals with minimal training in education, could provide a significant decrease in~     the morbidity of the disease.~      Objective. Determine the effectiveness, in terms of prevention of exacerbations (future~     risk) and improved asthma control (current control) of an educational program based on a~     reduced or minimal intervention.~   "
135421|NCT01282346|"~     To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce~     intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional~     surgical treatments have failed.~   "
135422|NCT01282333|"~     This phase I clinical trial is studying the side effects and best dose of veliparib and~     gemcitabine hydrochloride when given with cisplatin in treating patients with advanced~     biliary, pancreatic, urothelial, or non-small cell lung cancer. Veliparib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Veliparib may help cisplatin and gemcitabine hydrochloride work better by making tumor cells~     more sensitive to the drugs.~   "
135423|NCT01282320|"~     More than 60 % of women experience hot-flashes during postmenopausal and 20 % have serious~     symptoms. Use of combined estrogen/progesterone therapy reduces hot-flashes effectively. In~     2001, results from the randomized controlled WHI-study (Womens Health Initiative) showed~     increased risk for breast cancer and hearth-disease among users of combined~     estrogen/progesterone therapy. This reduced the use of combined estrogen/progesterone~     therapy. Many women seek alternative treatment for hot-flashes. They are often told that~     physical activity can reduce intensity and frequency of hot-flashes. The evidence for this~     advice is sparse.~      The primary hypothesis tested in the WHAT-study will be: Increased physical activity reduce~     frequency and intensity of hot-flushes among sedentary postmenopausal women with bothersome~     hot-flushes.~      The WHAT-study is designed as a pragmatic randomized controlled clinical trial. To answer~     the primary hypothesis we will need approximately 500 participants. The logistic in a~     pragmatic trial of a complex intervention are complicated and we decided to first run a~     pilot study with 50 participants as a feasibility study. The pilot gives us opportunity to~     gain experience with possible problems like withdrawals and injuries.~   "
135438|NCT01282125|"~     Recent clinical findings of research at Trondheim University Hospital suggest that surgical~     correction of the nose septum in addition to volume reduction of the nose cavity may be~     beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea~     syndrome(data not yet published).~      This study aims to compare nose obstruction prevalence in sleep apnea patients and the~     general population~   "
135439|NCT01282112|"~     This is a retrospective chart review study (700 charts from 2002 to 2010)of children from 0~     to 18 years of age who have undergone Brainstem Evoked Auditory Response (BEAR)testing using~     midazolam and pentobarbital protocol for moderate sedation. The specific aims of this study~     are two-fold:~        1. to determine the efficacy of intravenous pentobarbital during BEAR testing in the~          pediatric population using a standardized protocol; and~        2. to evaluate the incidence of adverse events (major and minor), paradoxical reaction and~          failed sedation and identify predictors for failure and adverse events if any.~   "
135424|NCT01282307|"~     Background:~      Rehospitalisation and discontinued treatment are common among patients with schizophrenia~     and is often associated with lack of insight into the illness. Improving patients' insight~     has been attempted through psychoeducation and standard treatment but without any~     considerable change. A newly developed method, Guided Self-Determination (GSD), originally~     developed and proved effective in difficult diabetes care has been adjusted to patients with~     schizophrenia. A qualitative evaluation of GSD has shown a positive influence on patients'~     insight into the illness.~      Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the~     care of patients with schizophrenia compared to treatment as usual. The following hypotheses~     will be tested:~      The method GSD will improve: Cognitive and clinical insight in patients, various domains of~     recovery, patients' self-esteem, psychopathology and social functioning.~      Material and method:~      The study design is a randomised controlled trial. The participants are diagnosed with~     schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach~     Teams and 3 Psychosis Teams in Region North. Participants complete four self-rating~     questionnaires, a demographic data sheet, an interview concerning psychopathology and an~     assessment of social functioning at baseline, and after 3, 6, and 12 month. All assessments~     will be conducted by the investigator, except for the assessment of social functioning, that~     will be measures by community nurses. Intervention with the method GSD will also be~     conducted by the community nurses but under supervision from the investigator. Fifty~     patients are randomly assigned to immediate receipt of individual training with the method~     GSD (intervention group) and 50 to a 12-month waiting list for individual training with the~     method GSD (control group).~      Perspectives:~      In mental health nursing practice in Denmark there is no tradition for empirical research as~     the basis of psychiatric nursing - unverified theories or general empirical consensus of~     good clinical practice are often the foundation of psychiatric nursing. If the method GSD~     proves effective in the care of patients with schizophrenia, this study contributes to an~     evidence based nursing intervention, which is ready for further research on implementation~     in mental health nursing practice.~   "
135425|NCT01282294|"~     This post market clinical follow-up is to confirm the clinical usefulness of the Expert~     Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia~     fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific~     questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse~     Events or complications.~   "
135426|NCT01282281|"~     Background: Most psychotropic medications that are effective in the treatment of Bipolar~     Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no~     long-term study in BD that has examined specifically the association of inflammation with~     EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults~     with BD who are being started on a medication ; 2) to compare change in EMCs in youth and~     adults treated for BD; 3) to measure change in EMCs associated with use of different~     medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD~     and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are~     associated with EMCs will be measured.~   "
135427|NCT01282268|"~     To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the~     treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)~   "
135428|NCT01282255|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the change in~     disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to~     placebo in subjects with active Rheumatoid Arthritis (RA).~   "
135429|NCT01282242|"~     This study was jointly developed and is jointly led by investigators at Massachusetts~     General Hospital and the intramural division of NINDS. We are doing this research study to~     find out if Activase ® (also called alteplase or rt-PA) can safely be given to people with~     an acute ischemic stroke when their stroke onset was not witnessed making them ineligible~     for standard thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help~     people recover better from their stroke.~      The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to~     people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if~     rt-PA is effective if given to people who are selected for treatment based on MRI evidence~     of an early stroke, and 3) get information about this new MRI diagnostic methods for guiding~     stroke treatment.~   "
135430|NCT01282229|"~     The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP~     protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG)~     laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and~     Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.~   "
135431|NCT01282216|"~     This research is being done to understand the effects of certain types of bone marrow~     transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your~     family members as the bone marrow donor, for your cancer. Part of that BMT involves a~     chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This~     research is being done to understand the effects of Cyclophosphamide on the immune system.~   "
135432|NCT01282203|"~     The main objective of this post-marketing observational study is to collect data from the~     use of general anesthesia in patients undergoing any surgery to create local~     recommendations. These data will be based on the evaluation of volatile induction and~     maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring~     general anesthesia for surgery in terms of quality of anesthesia and its influence on~     cardiovascular system in common clinical practice in Kazakhstan.~   "
135433|NCT01282190|"~     Evaluate the effectiveness of motivational interviewing to improve lipid control and~     cardiovascular risk in patients with dyslipidemia.~   "
135434|NCT01282177|"~     The overall objective of this study is to provide ongoing assessment of the safety and~     effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza~     like illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a~     cohort of Canadian HCP (Health care providers). Given the uncertainties around the timing of~     the provision of seasonal influenza immunization to HCP for the 2009/10 influenza season,~     this study will focus on evaluation of safety and effectiveness of pandemic influenza~     immunization in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and~     3.~   "
135435|NCT01282164|"~     The purpose of this study is to find out if the Glucagon Stimulation Test (GST) is a~     reliable alternative to the Insulin Tolerance Test (ITT) for diagnosis of Growth Hormone~     Deficiency (GHD) and adrenal insufficiency. In some patients the accuracy of the GST for~     evaluation of adrenal insufficiency is compared to the ACTH stimulation test.~   "
135436|NCT01282151|"~     This study is:~        -  A multicenter, prospective, randomized, phase 3 trial.~        -  To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a~          front line treatment of patients with non-squamous cell lung cancer.~        -  276 patients will be recruited.~   "
135437|NCT01282138|"~     The purpose of this study was to evaluate ocular responses with different allergen~     provocation methods.~   "
135440|NCT01282099|"~     While near infrared spectroscopy is an exciting technology, scientific rigor is required in~     order to optimize its appropriate use in the clinical arena. This study will explore the~     feasibility and clinical applicability of data obtained from the NIRS device. The ability to~     noninvasively monitor peripheral perfusion remains an area of intense research. The most~     widely used method is pulse oximetry. The international mandate of its use in operating~     rooms in the early 1990s after the publication of the Harvard minimum standards for~     monitoring speaks to its unquestionable utility. Its pervasive application notwithstanding,~     pulse oximetry merely provides a calibrated ratio of arterial and venous hemoglobin~     saturation. While this data is valuable, time-tested, and even may hold the promise of~     accurately noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of~     vulnerable, yet viable tissue beds -- are beyond the predictive values of currently~     available devices.~   "
135441|NCT01282086|"~     The main objective of this post-marketing observational study (PMOS) is to collect data of~     using general anesthesia in patients undergoing any surgery to create local recommendations.~     These data will be based on the evaluation of volatile induction and maintenance anesthesia~     (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for~     surgery in terms of quality of anesthesia and its influence on the cardiovascular system in~     common clinical practice in Ukraine.~   "
135442|NCT01282073|"~     Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic~     membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The~     investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a~     reasonable alternative with fewer side effect.~   "
135443|NCT01282060|"~     The purpose of this study is to asses the link between glycaemic balance (summarised by~     HBA1C LEVEL) and specific causes of death.~   "
135444|NCT01282047|"~     Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to~     evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be~     followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.~   "
135445|NCT01282034|"~     INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures~     represent ones of the most frequently used methods for chondral and osteochodral defects~     repair and considered as standard techniques.~      MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a~     single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium~     enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is~     able to promote the tissue regeneration in case of severe and large chondral/osteochondral~     lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a~     clinical study.~      OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to~     reference standard surgical techniques (microfractures and subchondral drilling) for the~     treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as~     innovative surgical approach.~      STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled,~     two-arm, single-blind and involves eleven European centres and 150 patients. Eligible~     subjects will be randomly allocated to one of the two treatment groups: control group,~     treated with marrow stimulation techniques, and treatment group, treated with MaioRegen®~     implant.~      Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the~     entry criteria for the trial. Before enrolment, each subject should declare his voluntary~     participation to the study by informed consent signature.~      Arthroscopic control will be carried out immediately before the randomization and thus~     surgical treatment, to confirm the characteristics of the lesion to be treated and~     finalizing the recruitment.~      For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and~     during each follow-up visit the Case Report Form (CRF) will be filled in the specific~     section.~      Within the CRF, at each follow-up section, commonly used and specific scores will be~     assigned for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring~     System).~      Patients selected will be randomized to undergo one of two study groups, as prescribed by~     the randomization list.~   "
135446|NCT01282021|"~     Alloimmunization to blood products in transfused patients is a recognized management~     challenge in the clinical setting. In particular the ethnic and racial specificity of RBC~     antigens and the limited availability of matched healthy volunteer blood donors have~     intensified the dilemma. The presence of low prevalence clinically significant RBC antigens~     among minorities account for the higher rate of alloimmunization observed in patients from~     this group. This is partly due to the racial and ethnic differences between the blood donor~     and recipient populations in the US.~      The increasing number of new Ethiopian-American immigrants in the US presenting to the~     health care system with blood transfusion requirements makes understanding the unique~     transfusion needs of this minority population imperative. Although the majority of African~     Americans claim origin to West Africa, Ethiopians, being from East Africa, represent a~     rapidly growing population in the United States. Furthermore, identifying genetic~     similarities and disparities to their West African counterparts will certainly have clinical~     implications in terms of transfusion support and disease modifiers. This additional~     information would help in understanding the natural history and transfusion requirements of~     certain debilitating diseases, such as Sickle Cell Disease, which are known to occur more~     commonly in African Americans. Identifying ethnically and racially similar individuals could~     assist in recruiting healthy volunteer donors with similar RBC antigen profiles potentially~     supplementing the rare donor pool.~      Although extensive archeological and sporadic serologic RBC antigen studies have been~     conducted in Ethiopia there are no population wide RBC antigen molecular studies. Our study~     population is selected by altitude and migration history. Ethiopia being in close proximity~     to Red Sea in the northeast, Indian Ocean in the southeast and the rest of Africa in the~     south/west has diverse population.~      The study is a population based analysis of genetic variation of blood group antigens in~     three distinct and conserved Ethiopian sub-populations. Statistical analysis using~     Chi-square tests will be performed for each blood group antigen to detect differences in the~     distribution between the three sub-populations. The investigators will travel to Ethiopia to~     collect blood samples which will be analyzed in DTM at NIH using the standard serologic~     methods and currently available molecular genotyping systems. Samples will also be stored~     for future high throughput sequencing analysis and other studies.~      The study will be a systematic analysis of the distribution of blood group antigens in~     Ethiopian sub-populations. Furthermore, new variants could be detected allowing insight in~     correlations of particular genotypes and phenotypes.~   "
135447|NCT01282008|"~     BACKGROUND:~      This document outlines the study design and procedures to be used to evaluate a series of~     corrective statements to augment consumer knowledge and beliefs about smoking as related to~     past actions of tobacco companies. The statements were ordered by a U.S. Federal Court in~     U.S. v. Philip Morris USA, Inc., and are intended to target potential misperceptions~     resultant of past marketing and promotion practices undertaken by the tobacco industry.~      OBJECTIVES:~      The U.S. Department of Justice has asked NCI to take the lead on developing and testing~     corrective statements with adult and youth audiences to ensure both message comprehension~     and avoidance of unintended consequences of message exposure, such as boomerang effects,~     smoking triggers, or knowledge gaps.~      The court has identified five areas that the statements shall address:~        1. The adverse health effects of smoking;~        2. The addictiveness of smoking and nicotine;~        3. The lack of any significant health benefit from smoking low tar, light, ultra light,~          mild, and natural cigarettes;~        4. The tobacco industry s manipulation of cigarette design and composition to ensure~          optimum nicotine delivery;~        5. The adverse health effects of secondhand smoke.~      ELIGIBILITY:~      Message testing will be undertaken with the following audiences:~        -  Current smokers (with an oversample of low socioeconomic status individuals)~        -  General population nonsmokers and former smokers (with an oversample of low~          socioeconomic status individuals)~        -  Spanish-speaking Hispanics~        -  Youth age 14-17~      DESIGN:~      Both qualitative and quantitative methods (focus groups and post-test comparison group~     Web-enabled surveys) will be used to develop and test a range of corrective statements in~     the five areas outlined by the court.~        -  Focus group participants: 48-64~        -  Survey participants: 2500~   "
135479|NCT01281592|"~     This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or~     appropriate target dose if MTD not reached to identify the recommended phase 2 dose of~     LOR-253 HCl in patients with advanced or metastatic solid tumours.~   "
135480|NCT01281579|"~     The purpose of this study is to determine blood and urine concentrations of canagliflozin~     and glucose in healthy adult volunteers after administration of single and multiple doses of~     canagliflozin.~   "
135448|NCT01281995|"~     Background:~      - Corticosteroids have been used to treat inflammation and immune system diseases for~     decades. However, despite their widespread use, there is little information on the specifics~     of how corticosteroids affect the immune system in humans. The Center for Human Immunology,~     Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone~     hydrocortisone affects the immune system in healthy volunteers, and in doing so to~     understand how hydrocortisone given at different doses works in treating many immune and~     inflammatory conditions.~      Objectives:~      - To evaluate the effects of hydrocortisone on the immune and inflammatory responses of~     healthy volunteers over the short and intermediate term (up to 28 days after~     administration).~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a full medical history and physical examination, and~          blood and urine tests. At this visit, participants will be separated into two groups,~          with each group scheduled to receive a different amount of hydrocortisone during the~          study visit.~        -  One week before the study visit, participants will provide a blood sample for baseline~          testing.~        -  Participants will be admitted for a 24-hour inpatient stay that will involve frequent~          blood draws. Between blood draws, participants will be able to work, watch TV, walk~          around, and so on, and will be provided with regular meals.~        -  Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be~          divided into two further sets of groups with different blood draw schedules:~        -  Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24~          hours after the hydrocortisone infusion.~        -  Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours,~          with timing based on data from the previous groups blood test results.~        -  Participants will provide additional blood samples 7 and 28 days after the in-patient~          visit.~   "
135449|NCT01281982|"~     Background:~      - The blood-brain barrier helps to protect the central nervous system (brain and spinal~     cord) from harmful toxins, but also prevents potentially useful chemotherapy from reaching~     brain tumors. The barrier is formed by tight connections between blood vessel cells and~     molecules found on the surface of brain blood vessels such as Permeability-glycoprotein~     (Pgp). Pgp may influence whether patients with brain tumors known as gliomas respond to~     chemotherapy and what side effects they may experience. The compound~     (11C)N-desmethyl-loperamide ((11C)dLop) reacts to Pgp molecules, and therefore may be used~     with positron emission tomography (PET) imaging to study the blood brain barrier.~      Objectives:~      - To study the ability of PET imaging with (11C)dLop to evaluate the blood brain barrier in~     brain tumor patients.~      Eligibility:~      - Individuals at least 18 years of age who have a brain tumor with characteristics that may~     be imaged with techniques such as magnetic resonance imaging (MRI) andPET.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine tests, and tumor imaging studies (fluorodeoxyglucose PET and MRI scans~          with contrast agent).~        -  The (11C)dLop scan will take 1 hour to perform. Participants will be asked to return~          for blood and urine tests approximately 24 hours after the PET scan.~        -  Participants will have followup visits at least every 4 months by repeating a complete~          history and physical exam and brain MRI. Participants may have repeat scans with~          (11C)dLop at various points in the course of cancer treatment, but will not have these~          scans more than twice in a 12-month period.~        -  Participants will be followed for as long as possible during treatment to see if~          imaging with (11C)dLop correlates with response to the treatments....~   "
135450|NCT01281969|"~     Background:~      - Some children experience a sudden onset of symptoms similar to those found in~     obsessive-compulsive disorder that may be caused by the body s reaction to an infection with~     streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s~     immune system reacts against brain cells following a streptococcal infection, the condition~     is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with~     streptococcal infections). The immune system response can be inactivated by treatment with a~     drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on~     IVIG s effects on the immune system of children with PANDAS, including whether IVIG is~     helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are~     interested in examining whether IVIG is an appropriate treatment for PANDAS and its~     associated symptoms.~      Objectives:~      - To test the safety and effectiveness of intravenous immunoglobulin for the treatment of~     obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric~     disorder associated with streptococcal infection).~      Eligibility:~      - Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or~     without a tic disorder) with sudden onset of symptoms following Group A streptococcal~     bacterial infections.~      Design:~        -  Participants will be screened by telephone to obtain medical history and other~          information, followed by in-person screening at the National Institutes of Health~          Clinical Center.~        -  Participants will be admitted to the hospital to receive 2 days of infusions of either~          IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be~          performed during this visit.~        -  Six weeks after the inpatient stay, participants will return for further blood samples~          and other tests. Participants who did not receive the study drug, or who received the~          drug but did not respond to the initial IVIG infusion, will have the option to receive~          IVIG at this time.~        -  Followup visits will take place 3 months and 6 months after the first evaluation,~          followed by yearly follow-ups for 5 additional years.~   "
135451|NCT01281956|"~     Background:~      - The brain chemical serotonin helps nerve cells communicate. Previous research suggests~     that serotonin activity may be lower in brain areas where seizures start, and that~     increasing activity at the serotonin receptor site on nerve cells may help prevent seizures.~     Researchers are interested in determining whether the experimental medication PRX-00023,~     which increases the activity of serotonin receptors, can reduce seizure frequency in people~     whose seizures are not well-controlled on antiseizure medication. PRX-00023 has not~     previously been studied in people with epilepsy and has not previously been given to people~     taking antiseizure medication at the same time.~      Objectives:~      - To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures~     that start from only one part of the brain.~      Eligibility:~      - Individuals between 18 and 65 years of age who have frequent epileptic seizures even after~     trying at least two different standard anti-seizure medications (either at the same time or~     one after the other).~      Design:~        -  The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week~          period. Individuals who choose to participate in additional studies may be an inpatient~          during some of these visits.~        -  Participants will be screened with a medical history and physical examination, blood~          and urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET~          and MRI scans~        -  Participants will have a 6-week observation and evaluation period before starting the~          study medication. Participants who have at least four seizures during this period will~          be eligible for the treatment portion of the study.~        -  All participants will receive either PRX-00023 or a placebo pill twice daily for 12~          weeks, and will have regular clinic visits with blood samples and imaging studies.~        -  After the 12-week period, participants will have a 2- to 3-week washout period without~          any study medication.~        -  Participants will then have another study medication period, and will receive the~          opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase.~          Participants will continue to have regular clinic visits with blood samples, ECG, EEG~          and neuropsychologicalstudies.~        -  One month after the end of the second study medication phase, participants will have a~          followup evaluation with a physical examination, blood tests, ECG, EEG, mood and~          neuropsychological tests.~      Outcome measures:~      The primary outcome measure for drug efficacy will be:~      Mean difference in seizure frequency comparing the active and placebo periods.~      Secondary outcome measures for efficacy will be:~      Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023~     than placebo~      Hamilton Depression and Anxiety Rating scales~      Performance on mood and neuropsychological testing scales~   "
135452|NCT01281943|"~     This Phase II study will use the MTD from a previous Phase I study at the recommended dose~     for the combination regimen from the Phase I trial, Doxil 25mg/m2 IV Q 4 weeks and~     temsirolimus 25mg IV Q week.~   "
135453|NCT01281930|"~     Abscesses or boils are becoming more common every year and are a common reason children~     come to the Emergency Department. For the abscess to heal the skin needs to be opened to let~     the pus come out. Often doctors put something called packing material or gauze into the~     abscess space to help aid in healing. It is not known if the type of packing that is done~     is necessary or if a more simple treatment is as good or better. With informed consent we~     randomly place a child into one (1) of two (2) groups in this study that will say if the~     child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece)~     of gauze is placed after the abscess/boil is opened and the fluid is drained. After~     treatment in the emergency department the child will be scheduled to follow-up in the~     Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are~     scheduled. At this visit the healing of the wound will be checked by the staff in the clinic~     and will be scored. With this evaluation of the wound the hypothesis that for a simple~     superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective~     as placement of traditional gauze packing.~   "
135481|NCT01281566|"~     The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding~     problems in premature newborn infants.~   "
135482|NCT01281553|"~     The purpose of this study is to compare the efficacy and tolerability of cisapride with~     placebo in infants and children with gastro-oesophageal reflux disease (GORD).~   "
135454|NCT01281917|"~     The investigators want to find out if the drugs Velcade and temsirolimus given together are~     effective in treating cancer. Velcade and temsirolimus are each FDA approved individually~     for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and~     temsirolimus for renal cell carcinoma) but are not currently approved in combination for~     B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2~     drugs together will improve the period of time that the patient's cancer is stopped or~     slowed from growing and causing symptoms.~   "
135455|NCT01281904|"~     There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue~     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms~     experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range~     from 30% to 82% within the first 5-years of diagnosis and there are few treatment options~     for PCRF and these treatments require the availability of a trained practitioner, are~     associated with significant costs, pose a sizeable burden for the patient, or have~     unacceptable side-effects.~      Acupressure is a technique derived from acupuncture, a component of Traditional Chinese~     Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand,~     elbow, or with various devices to treat disease. Pilot studies have demonstrated that~     self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer~     survivors. Acupressure can also have positive effects on sleep quality in cancer patients~     and other chronically ill populations. Self-administered acupressure is a non-toxic and~     inexpensive treatment that requires minimal instruction. It also requires little effort and~     time on the part of the patient to successfully complete. Thus, acupressure appears to be a~     promising treatment for PCRF and associated symptoms.~      The investigators are conducting a single-blind, placebo controlled study to examine the~     specific effect of two opposing acupressure treatments compared to standard of care. The~     goal of this study is to determine the benefit of acupressure on treating persistent fatigue~     experience by many patients after completing their cancer treatment. Study patients will be~     randomized into one of three groups: two different types of acupressure or a standard of~     care arm. For those participants randomized to receive acupressure, the technique will be~     taught to them by a study nurse trained by an acupressure specialist. Participants will be~     asked to perform the acupressure daily over the next six weeks, during which time they will~     record their fatigue and be asked to wear an activity monitor to have their daily activity~     levels monitored.~   "
135456|NCT01281891|"~     Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate~     to severe and can therefore influence the postoperative course of event and result in~     delayed postoperative mobilization and prolonged hospitalization. It is therefore necessary~     to find the most optimal method for alleviation of pain for these patients. Traditionally,~     this has been managed by epidural analgesia, continuous peripheral nerve blocks, parental-~     or spinal opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney,~     Australia developed a local infiltration analgesia (LIA) technique. The technique was~     introduced in Scandinavia during 2001 and has been shown to be efficacious during knee~     surgery. The LIA technique is based on a systemic infiltration of a mixture of a long-acting~     local anaesthetic (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and~     epinephrine into the tissue around the surgical field to achieve satisfactory pain control~     with little physiological disturbance. A catheter is left from the skin and into the joint~     cavity, allowing repeated injection on the morning after surgery (10). Effective pain relief~     with early mobilization and reduced hospital stay has been reported following total knee~     arthroplasty and, recently, following unicompartmental knee arthroplasty.~      The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal~     morphine, the standard of care in our hospital.~   "
135457|NCT01281878|"~     In this study the investigators will prospectively analyze the reduction of urinary oxalate~     excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum~     level response relationship with PLP as an i.v. solution used orally in 12 patients with~     primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to~     increased endogenous oxalate production, urolithiasis and end stage renal disease.~   "
135458|NCT01281865|"~     This phase I/II clinical trial is studying the side effects and best dose of everolimus when~     given with imatinib mesylate and to see how well they work in treating patients with locally~     advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib~     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
135459|NCT01281852|"~     This phase I/II clinical trial studies the side effects and best dose of veliparib when~     given together with paclitaxel and cisplatin and to see how well they work in treating~     patients with cervical cancer that has spread to other places in the body and usually cannot~     be cured or controlled with treatment or that has come back. Drugs used in chemotherapy,~     such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving more than one drug (combination chemotherapy) and giving~     chemotherapy together with veliparib may kill more tumor cells.~   "
135460|NCT01281839|"~     The purpose of this study is to investigate the effectiveness and safety of TMC435 compared~     with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed~     after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a~     and ribavirin as part of their treatment.~   "
135461|NCT01281826|"~     The purpose of this study is to~        1. Assess bone marrow edema within the VCF by use of a DE CT virtual noncalcium image~          compared with MR imaging as standard reference.~        2. Evaluate parameters related to the BME of the collapsed vertebral body on DE CT virtual~          noncalcium images, such as the morphologic signs, visual qualitative detection, and~          quantitative values.~   "
135462|NCT01281813|"~     The primary objective of this trial is to continue the provision of DRV/rtv to adult~     patients who have completed treatment with DRV/rtv in the clinical trials TMC114-C211,~     TMC114-C214, or TMC114-TiDP31-C229, sponsored by Tibotec Pharmaceuticals, who continue to~     benefit from the use of DRV/rtv, and who live in a country where DRV is not commercially~     available, is not reimbursed, or cannot be accessed through another source (eg, access~     program, government program).~   "
135463|NCT01281800|"~     This is a randomised Phase II clinical trial to assess and compare efficacy and safety~     profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long~     infusion.~   "
135464|NCT01281787|"~     The aim of this study is to assess whether prophylactic treatment with metoprolol or~     losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing~     thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic~     peptide (NT-proBNP), measured in the perioperative period.~   "
135465|NCT01281774|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     CSL112 in healthy volunteers after multiple infusions.~   "
135466|NCT01281761|"~     Based on the results from preclinical study, the investigators suggest that the addition of~     simvastatin at a dose of cardiovascular use (40 ~ 80 mg qd daily) may overcome cetuximab~     resistance in KRAS mutant colorectal cancer via B-Raf protein degradation and inducing Bim~     and Bad. Given the result of a phase II FOLFIRI plus cardiovascular dose of simvastatin~     (80mg qd daily) and this study, phase II study of conventional cetuximab treatment with 40~     mg simvastatin is planned in metastatic colorectal cancer patients with KRAS mutation.~   "
135467|NCT01281748|"~     Clinical practice guidelines for the management of chronic obstructive pulmonary disease~     (COPD) recommend treatment with systemic corticosteroids during acute exacerbations. The~     results of a Cochrane systematic review show that treatment with systemic corticosteroids~     improves lung function over the first 72 hours of an exacerbation of COPD but the effect on~     other outcomes, particularly length of hospital stay, is unclear, so further research should~     be directed at determining the risk-benefit ratio, particularly those at high risk of~     developing adverse drug reactions. In critically ill patients, corticosteroid treatment is a~     risk factor of infections, hyperglucemia and critical-illness neuromuscular abnormalities,~     and these conditions are associated with an increased morbidity and mortality. The effect of~     treatment with systemic corticosteroids in COPD patients with acute exacerbation requiring~     mechanical ventilation has not been evaluated investigated so it is unknown if the~     corticosteroids could reduce the duration of mechanical ventilation and the length of~     intensive care unit (ICU) stay or if, on the contrary, the development of adverse events~     could lead to a longer time on mechanical ventilation and ICU stay.~      PRIMARY OBJECTIVES: To evaluate the effect of corticosteroids on the duration of mechanical~     ventilation, the length of ICU stay, the need for tracheal intubation in patients treated~     with non-invasive mechanical ventilation. To evaluate the frequency of adverse events:~     secondary infections, pneumonia, arterial hypertension, hyperglucemia, gastrointestinal~     bleeding, and critical-illness neuromuscular abnormalities. DESING: Multicenter,~     prospective, randomized, double blind, placebo-controlled clinical trial.The treatment group~     will receive intravenous methylprednisolone for 10 days and the control group will receive~     isotonic saline solution.~   "
135468|NCT01281735|"~     The purpose of the study is to describe and characterize CML in a large pediatric cohort of~     patients.~   "
135469|NCT01281722|"~     Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is~     resistant to most of the current therapeutic regimens. Incidence rate of melanoma in~     patients with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal~     counterpart. SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor~     related protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR)~     and it regulates epidermal homeostasis and T-cell function. The preliminary results of~     comparing human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected~     members from the family with MDM revealed that T-cell activation was impaired in PBMCs with~     the heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed~     melanoma.) Since there is currently no effective treatment for metastatic melanoma,~     identifying novel molecular mechanisms may lead to development of new treatments for~     metastatic melanomas.~      Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis:~     1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic~     potential. 2.Higher frequencies of cells capable of initiating melanoma xenografts when~     using IL2Rγ-/- NOD SCID mice. These data confirmed the interaction between T cells and MSCs.~      In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs.~     Investigating and verifying the interaction between T-cells from patients with MDM and~     melanoma cells to confirm the SLURP-1 function of tumorigenesis in xenotransplant mice~     (IL2Rγ-/- NOD SCID) model. To reveal the role of SLURP-1 silencing in melanoma cell lines by~     using not only A2058 , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and~     ABCB5- melanoma cells through the tumorigenesis, apoptosis,angiogenesis, proliferation,~     melanosphere formation assays.~      The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in~     melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.~   "
135470|NCT01281709|"~     This questionnaire-based study was focused on understanding primary care physician's wish~     toward provision of integrated health care, associated knowledge and attitude, and analysis~     of influencing factors affecting their choices.~   "
135471|NCT01281696|"~     The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and~     cisplatin in treating breast cancer patients with central nervous system metastasis~     (including brain parenchymal and leptomeningeal metastasis).~   "
135472|NCT01281683|"~     Hepatocellular carcinoma (HCC) is a major health problem worldwide. For patients with~     intermediate-stage disease, i.e., large or multifocal HCC without vascular invasion or~     extrahepatic spread, transarterial chemoembolization (TACE) is recommended as first line~     therapy with survival advantages. TACE can be performed repeatedly in patients with~     recurrent tumors who have adequate liver function reserves.~      Two clinical issues of TACE remain un-resolved. The first issue is the possibility of~     TACE-induced liver parenchymal damage, which may influence further treatment options and~     outcome of the patients. Conventional ways to evaluate liver functional reserves, including~     Child-Pugh score, biochemistry and metabolic tests, and ultrasound elastography, are~     relatively non-specific. The second issue is the difficulty in evaluating TACE efficacy,~     which cannot be reliably measured by conventional, volumetric response criteria. Both issues~     should be resolved to optimize patient care.~      Recently dynamic contrast-enhancing magnetic resonance imaging (DCE-MRI) is increasingly~     used to analysis perfusion changes of the liver, and can be applied to both liver parenchyma~     and tumors. Previous studies have shown clinical applications of perfusion imaging, such as~     evaluating the severity of liver fibrosis and cirrhosis, assessing the effectiveness of~     anti-angiogenic therapy, and evaluating tumor viability after locoregional therapy. DCE-MRI~     can be performed with a hepatobiliary specific contrast agent, Gd-EOB-DTPA (Gadoxetic acid,~     Primovist®, Bayer Schering), with dual benefit of dynamic phase and the delayed~     hepatobiliary phase imaging. The hepatobiliary phase imaging can provide additional~     information for hepatic lesion characterization and the functional status of the~     hepatocytes. We hypothesize that imaging parameters of DCE-MRI with Gd-EOB-DTPA could~     reflect non-tumorous liver parenchymal changes and can be used to predict and monitor~     treatment response in patients with HCC after TACE.~      In this prospective cohort study, we will recruit patients referred for TACE with~     newly-diagnosed unresectable HCC or tumor recurrence after operation. Patients treated with~     radiofrequency ablation (RFA) will be recruited as a control group, since RFA is associated~     with minimal damage to the non-tumorous liver parenchyma. Key eligible criteria include~     chronic hepatitis B, histological or clinical diagnosis of HCC, tumors that are not amenable~     to surgical treatment and referred for TACE or RFA, ECOG performance status 0 or 1,~     Child-Pugh class A or B liver function, and measurable tumors (by RECIST 1.1). Eligible~     patients will receive the designated treatment (TACE or RFA) according to the current HCC~     treatment guidelines. DCE-MRI with Gd-EOB-DTPA will be used to analyze the non-tumorous~     liver parenchymal changes and treatment response, and will be performed at baseline, 3 days~     and 1 month after treatment, and then every 3 months for a maximum of 2 years. The primary~     endpoint of this study is progression of liver function reserve. The estimated time for~     patient recruitment is about half a year, and 40 patients and 20 patients will be recruited~     in the TACE and the RFA treatment group, respectively. The imaging parameters of the~     non-tumorous parenchyma and the tumors will be analyzed and correlated with clinical liver~     function parameters, and hepatic functional and tumor outcome of the patients.~   "
135473|NCT01281670|"~     Muscle force, explosive strength and vertical jump height are important parameters~     determining the performance of athletes. Traditionally, high intensity resistance training,~     explosive strength training and plyometric training are used to improve athletes'~     performance. Recently, whole body vibration training is recommended for increasing muscle~     force and explosive strength, because vibrating platform could provide high gravitational~     acceleration to activate muscle activation and sensory input to spinal reflex. Design:~     Prospective and randomized control study. Subjects: Healthy male subjects with regular~     training or competition at least 6 hours per week. Methods: H-reflex, V-wave, triceps surae~     activation level and rate of force development are measured at pre-training, mid-training~     (5th week) and post-training. Subjects will receive 8 weeks, 3 times/week, training programs~     including plyometric jumping or static squat on whole body vibration platform. Data~     analysis: Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL) and~     two-way ANOVA will be used for data analysis.~   "
135474|NCT01281657|"~     The purpose of this observational study is to collect long-term data on safety and~     effectiveness of fingolimod, particularly including clinical disease and patient outcome~     related parameters such as relapse and disability, in patients who have participated in~     prior trials within the fingolimod clinical development program. Furthermore, this study~     explores the incidence of selected safety related outcomes of fingolimod treatment during~     follow-up visits within the context of routine medical practice.~   "
135475|NCT01281644|"~     The investigators hope to establish whether or not the diode laser, a longer-wavelength~     laser, is effective in treating keratosis pilaris, and hopefully opening a door into the~     discussion and management of this skin condition. The primary outcome of interest is the~     difference in the overall blind rater severity scores of the treated versus the untreated~     sites. The secondary outcome of interest is the change in the patient's self-rated severity~     score of the treated site. To account for potential natural disease progression or~     regression, the investigators will also compare patient mean changes to the mean changes in~     severity scores of the untreated site.~   "
135476|NCT01281631|"~     This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001~     in subjects with ALS.~   "
135477|NCT01281618|"~     The purpose of this study is to determine the association between acid reflux and cell~     changes in Barrett's esophagus.~      Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser~     degree of stromal activation.~      Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive~     BE epithelial proliferation.~   "
135478|NCT01281605|"~     This study compared the effectiveness and safety of two treatment algorithms for insulin~     detemir initiation and titration: active titration algorithm (performed by investigator~     weekly) versus usual titration algorithm (performed by study subjects weekly) in patients~     with type 2 diabetes poorly controlled by OADs.~   "
135485|NCT01281514|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal~     doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     carboplatin and PLD together with everolimus may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with carboplatin and PLD in treating patients with relapsed ovarian~     epithelial, fallopian tube, or peritoneal cavity cancer~   "
135486|NCT01281501|"~     The purpose of this study is to evaluate the immediate synergistic effect on the relief of~     severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of~     oral antacid and antispasmodic agent (the conventional treatment).~   "
135487|NCT01281488|"~     RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in~     planning surgery.~      PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG)~     fluorescence imaging in finding tumors in patients with kidney tumors~   "
135488|NCT01281475|"~     This study is designed to determine whether levodopa will lead to an improvement in the~     development and tremor in children with Angelman syndrome (AS).~      It has been suggested that levodopa, a medication that is usually used to treat Parkinson~     disease in adults, may help children with AS in their overall development and reduce the~     tremor that some of them have.~      If levodopa is found to be beneficial for children with AS, this could lead to a new~     treatment for AS.~      Funding Source - FDA-OOPD~   "
135489|NCT01281462|"~     This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing~     treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus~     treatment with IV doripenem.~   "
135490|NCT01281436|"~     The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health~     information technology (HIT) to improve health care decision making through the use of~     integrated data and knowledge management. The proposed study will evaluate the use of HIT~     for clinician decision support and tailored patient education on the implementation of the~     current guidelines for the prevention of obesity-related chronic conditions in health~     disparity populations of poor, minority youth who access care through SBHCs. The specific~     aims are:~        1. To evaluate the effectiveness of web-based training with and without computerized~          clinical decision support on provider's process and outcome behaviors related to~          implementing the current guidelines for prevention of obesity and related conditions.~           a. Process variables include the following: i. Provider knowledge, attitudes, and~          barriers to implementing the guidelines. ii. Parent perception of the interpersonal~          process of care (i.e., provider communication, collaborative decision making, and~          interpersonal style).~           iii. Parent perception of provider support for their child's healthy eating and~          exercise.~           b. Behavior outcomes include the following: i. Provider self-reported behaviors of~          identification and assessment of overweight, counseling on nutrition and physical~          activity, use of behavioral interventions, referrals, and cultural competency.~           ii. Documentation by chart review of body mass index (BMI) percentile for age and sex;~          appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for~          age, height, and sex; and ordering appropriate laboratory tests when indicated.~        2. To explore the role of HIT in the processes of system change for implementation of the~          guidelines for prevention of obesity and related conditions, including the~          facilitators, barriers, and impact of the care model on change.~   "
135491|NCT01281423|"~     Assess the safety and efficacy of ANA598 administered with Pegylated Interferon and~     Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.~   "
135492|NCT01281410|"~     The study is a monocentric, controlled randomized trial. Its an interventional method study.~     There is a control and an interventional group. The interventional group is receiving a~     specific inspiratory muscle training with Respifit (special device for inspiratory muscle~     training) during the first 30 days after allogenic stem cell transplantation.~      The investigators want to show that the training group gets stronger inspiratory muscles.~     The investigators measure the change of PIMAX values and MVV values.~   "
135493|NCT01281397|"~     Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal~     useful data about platelet function and viscoelastic properties of blood clot in patients~     undergoing cardiac surgery.~      The purpose of this study is to clarify whether it is possible to predict patients on~     excessive risk of perioperative bleeding using whole blood impedance aggregometry and~     rotational thromoelastometry.~      Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery~     disease. Another research goal is to determine the degree of response to antiplatelet~     therapy before and after surgery and to investigate whether patients by level of response to~     antiplatelet therapy before surgery have a higher risk of perioperative bleeding.~   "
135494|NCT01281384|"~     Uncovering the underlying cause of heart failure can be quite challenging and doctors often~     rely on imaging tests such as echo (heart ultrasound) to provide the answers. Cardiac MRI is~     emerging as another promising test because it gives very precise information on heart~     function and the amount of scarring in the muscle. Heart failure patients are increasingly~     being sent for cardiac MRI but the potential advantage that this test offers over others~     such as echo has not been fully explored.~      The purpose of this study is to determine if cardiac MRI provides more information on the~     cause of heart failure than traditional tests such as echo. In addition, if the information~     provided by this test always leads to an overall improvement in a patient's heart condition~     over time.~      This is a randomized study where subjects referred for clinically indicated heart failure~     workup to determine the best clinical management will undergo standard heart failure testing~     (including echo) OR standard testing PLUS cardiac MRI.~   "
135495|NCT01281371|"~     Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary~     hypertension treated with Sitaxentan need to be switched to an alternative therapy. This~     study will observe in which way the change of medication - in the clinical routine, without~     exception in charge of the treating physician - affects clinical and laboratory parameters~     and patient's quality of life.~   "
135509|NCT01281189|"~     The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is~     safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).~   "
135510|NCT01281176|"~     This randomized pilot clinical trial studies high-dose or low-dose vorinostat in combination~     with carboplatin or paclitaxel in treating patients with advanced solid tumors. Vorinostat~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving different doses of vorinostat together with~     carboplatin or paclitaxel may kill more tumor cells.~   "
136482|NCT01268527|"~     The purpose of this study is to investigate the efficacy, safety, tolerability and the~     concentration/response relationship of E6201 in subjects with psoriasis vulgaris.~   "
135496|NCT01281358|"~     Infants born very premature have biological risk factors for later developmental~     coordination disorder. Parental stereotyping of infants as fragile and other environmental~     factors, such as spending long periods laying on their backs, also contribute to motor~     delay. This study aims to develop and evaluate a computer-based intervention (Helping Our~     Premature infants ON to better motor skills - HOP-ON) for parents of preterm infants. HOP-ON~     will model evidence based strategies to develop infants' fine and gross motor skills, and~     aims to reduce parental stereotyping. It is hypothesised that infants whose parents receive~     the HOPON CD-ROM/DVD and Booklet will have better motor skills at 12 months adjusted age~     compared to those whose parents receive a control CD-ROM/DVD and booklet. Parents of infants~     born at less than 32 weeks gestation (target n = 138) will be recruited prior to discharge~     from the neonatal unit and randomised to either HOP-ON or control. The primary outcome is~     motor score (Bayleys III) at 12 months adjusted age. Other outcomes are parental confidence~     and perceptions of infant capability at 3 months and quality of movement, infant growth,~     fine and gross motor movement and parenting stress at 12 months. Data will be analysed blind~     to study condition and on an intention to treat basis.~   "
135497|NCT01281345|"~     Title: A multicenter observational study of candidemia cases among ICU patients in India~      Objective: Primary objective:~      Determine epidemiological and also clinical parameters of candidemia cases among ICU~     patients in India.~      Exploratory Objectives:~        1. Determine the prevalence of candidemia among ICU patients.~        2. Determine the prevalence of candidemia due to C. albicans and each species of~          non-albicans Candida species.~        3. Determine the demographics and risk factors for candidemia patients and comparison of~          relevant variables between the cases with C. albicans and non-albicans Candida species~          isolation.~        4. Describe physician practice in the management of candidemia cases - clinical and~          outcome.~        5. Determine the in-vitro antifungal susceptibilities of Candida isolates.~      Study description and purpose:~      Short description: Observational multicentre study in ICU patients. Study purpose:~     Epidemiological determinants of candidemia, management and outcome evaluation.~      How the study would help? It would help to evaluate outcomes of current management~     strategies and to develop future better management strategies of candidemia cases.~      Critical issues & risk: Site & center selection would be important No risk for patients~     included in the study as it is only observational study~      Study design:~      Site selection: A questionnaire will be circulated (annexure I) to all major tertiary care~     centers of India. The centers will be selected on the competence of candidemia diagnosis and~     availability ICU facilities. Expected number of centers ~ 20.~      Study period: October 1, 2010 - March 31, 2012 No of patients/sites: Consecutive all~     patients with candidemia detected during ICU stay over the study period will be included in~     the study in each site.~      Patient selection: Inclusion criteria:~        1. Admitted in ICU for > 48 hours (to coincide definitions of nosocomial or ICU-acquired)~        2. All age group patients will be included (pediatric & adult)~        3. Diagnosed as proven candidemia (isolation of Candida species from blood culture on ≥ 1~          occasion during ICU stay)~        4. Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after~          discharge from the ICU.~      Exclusion criteria:~      1. Patient already diagnosed of candidemia before admission in ICU Variables|: types of ICU,~     demographic data of patients, underlying illness, risk factors, severity scores, diagnostic~     methods, treatment characteristics (Annexure II) and treatment outcomes (Annexure III)~      Diagnosis of candidemia: Isolation of Candida species from blood culture (arterial/venous)~     by any method (conventional/ lysis-centrifugation/ automated system/ any other method). No~     intervention in diagnostic processes at any center. Centers not performing diagnosis of~     candidemia will be excluded from the study~      Data recording: both manual and online. The form of Annexure II will be filled up within 5~     days of diagnosis of candidemia; Annexure III will be filled up within 7 days of discharge~     from hospital or 30 days after starting the antifungal therapy or death of the patient~     (which over period is early).~      Data analysis: appropriate statistical method will be employed for analysis of data.~   "
135498|NCT01281332|"~     Hypothesis: A mechanical device when applied to the back of the neck at the onset of a~     menopausal hot flash will attenuate the severity and duration of symptoms providing women~     with a reassuring non-hormonal intervention to improve quality of life in the menopausal~     transition. This pilot study will evaluate the effectiveness of this unit.~      The mechanism of action of the device will not be revealed in advance.~   "
135499|NCT01281319|"~     Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy~     outcome, especially preterm labor and delivery. The most prevalent microorganisms involved~     in intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely~     detect the presence of the bacteria, pointing to colonized carriers only. There is no~     efficient and reliable diagnostic test to identify those subjects that have developed an~     infectious disease and are at risk of developing adverse pregnancy outcome.~      In order to identify women at risk for developing pregnancy complications, Promyco~     Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for~     the detection of urogenital Mycoplasma infection.~   "
135500|NCT01281306|"~     The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses~     of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed~     dose of valsartan (320 mg).~   "
135501|NCT01281293|"~     Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy~     since 1994. This post-market study is designed to follow the clinical course and outcomes~     for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure~     frequency, seizure severity, side effects burden, depressive symptoms, global impressions,~     and health care utilization will be evaluated. The results of this study will provide data~     to guide physicians and their patients in the use of VNS Therapy for patients with~     refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The~     data being collected is not for the purposes of confirmatory assessment.~   "
135502|NCT01281280|"~     This is a post-market, open observational long-term effectiveness follow-up study of~     participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in~     a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without~     adjunctive Vagus Nerve Stimulation Therapy.~   "
135503|NCT01281267|"~     Face transplantation surgery is the transfer of face tissue from a deceased human donor to a~     patient with a severe facial deformity. Face transplantation is an innovative reconstructive~     procedure that has the potential to significantly improve the lives of patients with severe~     facial injuries. The purpose of this study is to develop the best practices for facial~     transplantation that will improve the outcomes of future face transplant recipients.~   "
135504|NCT01281254|"~     To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo~     plus PLD as measured by progression-free survival (PFS)~      The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo~     plus PLD in women with recurrent partially platinum sensitive or resistant epithelial~     ovarian, primary peritoneal or fallopian tube cancer.~   "
135505|NCT01281241|"~     The main objective is to investigate mechanical alternans and MTWA in patients with heart~     failure caused by coronary artery disease to demonstrate a possible correlation between~     these two phenomena.~   "
135506|NCT01281228|"~     Glucagon-like peptide 1 (GLP-1) based therapies, such as exenatide, are already successfully~     employed in the treatment of Type 2 Diabetes (T2DM). Exenatide improves glycemic control and~     is associated with reduced food intake and body weight. The investigators hypothesize that~     it affects central reward and satiety circuits and that this may contribute to the weight~     loss.~   "
135512|NCT01281150|"~     This phase I clinical trial studies the side effects and the best dose of veliparib when~     given together with carboplatin and paclitaxel in treating patients with locally advanced or~     metastatic solid tumors. Veliparib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by blocking them from dividing. Giving veliparib with carboplatin and paclitaxel~     may work better in treating patients with solid tumors.~   "
135513|NCT01281137|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for~     cancer may help doctors learn more about changes that may occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in~     postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and~     are currently receiving letrozole on clinical trial IBCSG-35-07.~   "
135514|NCT01281124|"~     This phase II clinical trial is studying how well azacitidine works in treating patients~     with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy,~     such as azacitidine, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing.~   "
135515|NCT01281111|"~     The purpose of this study is to evaluate the safety, tolerability, and PK of different doses~     and dosing regimens of BG00012 administered with and without ASA compared to placebo.~   "
135516|NCT01281098|"~     To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy~     (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with~     high risk proliferative diabetic retinopathy.~   "
135517|NCT01281085|"~     Questionnaires are frequently used to evaluate shoulder function in various diseases or~     after surgery. However, measurement of shoulder function is presently a controversial issue.~     Shoulder movement analysis based on embedded sensors could be a promising alternative to~     questionnaires. Some studies already demonstrated the relevance of this approach. It has~     also been demonstrated that a simple testing procedure including only two arm movements~     produces comparable results to more complicated testing procedures. However, more studies~     are needed to extensively establish if this simplified testing procedure provides a~     trustworthy evaluation of patient shoulder function and its evolution.~      This study is a preliminary study which aims to develop a precise testing procedure which~     will be used in a future study aiming to evaluate measurement properties of a simple~     shoulder function test based on movement sensors.~   "
135518|NCT01281072|"~     Open label study to evaluate long term treatment effect of diapep277.~   "
135519|NCT01281059|"~     The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the~     ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease~     severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of~     the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid,~     in conjunction with other clinical information and medical history, for evaluating disease~     severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.~      Retrospective analysis based on multivariable analysis will determined if and which~     demographic, clinical and biochemical or imaging techniques data can assist in addition to~     the data derived from OBT in differentiation of NASH, NAFL and possibly normals.~   "
135520|NCT01281033|"~     To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients~     with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.~      Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the~     anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this~     substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in~     AMI is frequent and may result in obstruction of the microvessel network, and decreased~     efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or~     postdilation is the most simplistic approach to the problem of embolization, and may~     decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the~     problem of microvessel embolization include thrombectomy before stent implantation, and the~     use of antiembolic devices (filters and occlusive devices with retrieval of thromboembolic~     material after stent implantation). Most concluded studies on removing of thrombus before~     stenting used manual aspiration catheters and meta-analyses derived from these studies~     support the use of manual thrombus aspiration (MTA) catheters in the setting of primary PCI.~     MTA is currently recommended in the setting of primary PCI as a Class II b recommendation;~     level of evidence B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and~     aspiration based on the Bernoulli effect has been proven to be effective in decreasing major~     adverse events during PCI in saphenous vein grafts or native coronary arteries with~     angiographic evidence of thrombus, and 2 out of 3 concluded studies have shown a better~     reperfusion and clinical outcome in patients randomized to RT as compared to control.~   "
135521|NCT01281020|"~     A 6-month, parallel, non-interventional trial investigating the level of adherence and the~     impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with~     latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed~     combination therapy once in the evening. All patients participating in this observational~     study will be monitored for their adherence with the use of Medication Event Monitoring~     System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with~     selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This~     study will monitor objectively, for the first time, adherence and intraocular pressure~     control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact~     of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.~   "
135522|NCT01281007|"~     Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by~     herpes simplex virus (HSV). There are effective oral prescription antiviral medicines~     available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.~      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy~     and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with~     active recurrent genital herpes.~   "
136483|NCT01268514|"~     The objective of this prospective study is to evaluate short-term, mid-term, and long-term~     clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment~     of complex abdominal wall defects~   "
135523|NCT01280994|"~     The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas~     for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI~     contrast will be the investigators focus — 1) imaging of the 129Xe ventilation distribution,~     2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC),~     and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such~     imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting~     gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights~     regarding the normal resting heterogeneity of pulmonary gas exchange.~   "
135524|NCT01280981|"~     This was a multicenter, open-label extension study for subjects completing either of 2~     pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment~     phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3~     g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.~     After the last treatment period, a follow-up phone call occurred approximately 30 days~     (range 25 to 35 days) after the last dose of study drug.~   "
135525|NCT01280968|"~     The purpose of this study is to find out how vaccine-induced antibodies change the way the~     body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce~     nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The~     central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine~     accumulation and distribution of nicotine between the brain and other body tissues. This~     vaccine is investigational which means that it is still being tested in research studies and~     is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.~   "
135526|NCT01280955|"~     This phase I/II clinical trial will test the safety and the efficacy of post transplant~     administration of plerixafor in enhancing hematological recovery in humans. Patients who are~     appropriate candidates for myeloablative allogeneic stem cell transplantation from an~     HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for~     enrollment. The investigators plan to enroll a total of 50 patients for this study (30~     patients with HLA-matched sibling or matched unrelated donor transplant, and 20 patients~     with umbilical cord blood transplant). During phase I study, a small number of patients (3-6~     patients from each group) will be enrolled to determine the safety of post transplant~     administration of plerixafor. Patients will receive plerixafor given at 240 µg/kg~     subcutaneously every other day beginning at day +2 after transplant until day +21 or~     engraftment. Limiting toxicities are defined as primary or secondary graft failure,~     plerixafor-related severe premature ventricular arrhythmia or death. If safety criteria are~     met from the investigators phase I study, the investigators will proceed with phase II study~     to determine the efficacy of post transplant administration of plerixafor in enhancing~     haematological recovery. The experimental aspect of this study is the use of plerixafor and~     all other aspects of care will be in line with the standard of care. Both Phase I and Phase~     II patients will be combined for efficacy analysis, and data collected from this study will~     be compared with the investigators historical control. The results from this study will set~     the stage and provide the justification for a larger phase 3 trial.~   "
135527|NCT01280942|"~     The goal is to develop a two-tiered monitoring system to improve the care of patients at~     risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital~     (BJH). The investigators hypothesize that the use of an automated early warning system (EWS)~     that identifies patients at risk of clinical deterioration, with notification of nurses on~     the GHWs when patients are identified, will reduce the risk of ICU transfer or death within~     24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse~     oximeter to establish feasibility and to develop algorithms for a real-time event detection~     system (RDS) in these high-risk patients.~   "
135528|NCT01280929|"~     The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous~     injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of~     ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation~     alone in the regression of retinal neovascularization in eyes with high-risk proliferative~     diabetic retinopathy.~   "
135529|NCT01280916|"~     The primary purpose of this exploratory and developmental study is to evaluate a mind-body~     intervention for relapse prevention for women in addiction treatment. The proposed~     intervention, Mindful Awareness in Body-Oriented Therapy (MABT), is a novel mind-body~     intervention designed to enhance embodiment and to facilitate mindfulness through the~     combination of massage, body awareness exercises and the acquisition of mindfulness skills.~     The treatment goals of MABT include reduction of avoidant coping responses, increase of~     emotional-regulation, and decrease of trauma symptoms through access to and acceptance (vs.~     avoidance) of sensory and emotional experience. These are thought to be important for~     relapse prevention given the positive association between stress, negative affect and~     relapse; and risk of relapse associated with PTSD symptoms. Mind-body interventions in~     relapse prevention are of increased clinical and scientific interest, particularly for the~     potential to overcome automatic response patterns that are associated with lapse and relapse~     in substance use treatment. This proposal falls within the current NIDA research portfolio~     focus on the development of interventions that will help people better cope with stress,~     negative affect, and trauma.~      Specific Aims:~        -  Aim 1: To examine feasibility of recruitment to and retention in MABT as an adjunct to~          substance abuse treatment. Specifically, to describe a) study enrollment and barriers~          to recruitment, b) sample characteristics, c) response to randomization, d) session~          attendance, and e) loss to follow-up.~        -  Aim 2: To describe MABT acceptability to study participants and substance abuse~          treatment staff.~        -  Aim 3: To compare the effect of body-oriented therapy plus treatment-as-usual vs.~          treatment-as-usual only on reported days abstinent for overall substance use and~          primary drug use among women receiving substance abuse treatment, in order to estimate~          the effect size. Secondary analyses will examine for intervention effects on related~          outcomes including days abstinence on biochemical screens for substance use, body~          connection indicators, avoidant coping, stress reactivity, co-morbid psychological~          distress, and physical well-being.~   "
135530|NCT01280903|"~     The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a~     6-month program will improve leg exercise, fitness walking, and clinical outcomes (function,~     blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older~     adults with osteoarthritis of the knee and high blood pressure.~   "
135541|NCT01280760|"~     Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory~     dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces~     the airtightness of the facial mask used to perform non-invasive ventilation and induces air~     leaks. The presence of leaks at the patient-mask interface can increase the risk of~     patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally~     adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle~     is to record the diaphragmatic electrical activity and to control the ventilator. The~     investigators hypothesized driving the ventilator based on a neural signal (diaphragm~     electrical activity) would reduce patient-ventilator asynchronies in NIV~   "
135531|NCT01280890|"~     Dementia is a common and devastating disease in the elderly. No cure exist and there is an~     increasing need for care. To improve knowledge on how to provide better care for the~     patients with dementia in nursing homes, the investigators will carry out a controlled trial~     using two forms of education and developmental interventions towards the nursing home care~     staff: a structured framework (VIPS) and dementia care mapping (DCM)to develop~     person-centred care in a 10 months randomised controlled study. In accordance with the~     knowledge found in the literature the investigators hypothesize that both VIPS framework and~     DCM will be more effective than a traditional educational program about dementia provided to~     the staff in nursing homes. The positive effects will be seen as reduced agitation in~     patients, less use of psychotropic drugs and improved quality of life. Using VIPS framework~     and DCM will also have a better effect on staffs' well-being than traditional education in~     dementia. The aim of the study is to confirm or reject these hypotheses.~   "
135532|NCT01280877|"~     Aim is to validate that non-invasive brain stimulation can increase cortical excitability in~     the visual system. The investigators assess if transcranial alternating current stimulation~     (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS~     would improve visual functions within the defective visual field (primary outcome measure).~   "
135533|NCT01280864|"~     Hypotheses:~        1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in~          patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of~          the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes~          for both the afferent anorectal-cortical evoked potentials and efferent~          cortically-induced (magnetic) anorectal motor evoked potentials.~        2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal~          visceral hypersensitivity and anorectal sensory-motor dysfunction.~   "
135534|NCT01280851|"~     Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature~     and function is crucial to ensure optimal outcomes for both kidney donor and recipient in~     transplantation.~      Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy~     and vascular status, and renal scintigraphy to evaluate renal function. This imaging~     protocol exposes this relatively young and healthy population to a high radiation dose and~     potentially nephrotoxic contrast agents.~      The investigators hypothesize that a single MR-based examination in the preoperative~     evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate~     as the current multiple imaging work-up protocol.~   "
135535|NCT01280838|"~     Behavioral interventions designed to reduce risk of HIV and sexually transmitted infections~     (STIs) have mostly failed to consider clients of female sex workers (FSWs), who may act as a~     bridge to the general population. This study proposes to test a brief, one-hour counseling~     intervention with male clients in Tijuana, Mexico, to reduce their rates of unprotected sex~     (i.e., sex without a condom) with FSWs as well as their rates of infection with HIV and~     STIs. Finding an effective intervention for this population is important given the rising~     rates of HIV infection in Tijuana (as documented in earlier studies) and the large numbers~     of people crossing the border in both directions, many of them specifically to purchase sex~     from FSWs in Tijuana.~   "
135536|NCT01280825|"~     The purpose of this study is to collect DNA samples from patients undergoing routine care at~     the University of Chicago. These samples will be tested for differences in genes that may~     suggest greater risk of side effects or chance of increased benefit from certain~     medications. The results will be made available to the patient's treating physician and the~     researchers will track whether or not this information is used in routine health care.~   "
135537|NCT01280812|"~     The primary purpose of this study is to assess the efficacy of the mobile phone-based~     physical activity intervention on increasing physical activity compared to the control~     group.~   "
135538|NCT01280799|"~     This treatment development study seeks to investigate the most effective way to treat an~     adolescent's eating disorder and how best to involve the parents or caregivers in this~     process.~      Typically, parents and their child are seen together in therapy. However, this can sometimes~     be difficult for both the parents and the adolescent. Both parents and adolescents have~     different concerns and are struggling with different aspects of the eating disorder.~     Therefore, the treatment in this study involves the parents in treatment, but the majority~     of therapy sessions are conducted with the parent(s) and adolescent separately.~      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the~     first 16 weeks parents and the adolescent meet individually with the therapist. For the last~     8 weeks families meet with the therapist every other week. These last four sessions are~     conjoint - that is, adolescents and parents will meet with the therapist together. This is~     to help parents and adolescents come together as a family to continue to aid the adolescent~     in the treatment of his/her eating disorder.~      The investigators hypothesize that adolescents who receive this treatment will demonstrate~     improvement in eating disorder symptoms and body-mass index and that caregivers who~     participate will demonstrate decreased distress and caregiver burden. Furthermore, the~     investigators hypothesize that increases in psychological acceptance will be seen for both~     adolescents and caregivers post-treatment, and that treatment will be viewed as both~     credible and acceptable to both caregiver and adolescent.~   "
135539|NCT01280786|"~     This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to~     patients with advanced myeloid leukemia.~   "
135540|NCT01280773|"~     It has been showed that over assist and patient ventilator asynchrony often occur in~     mechanical ventilated patients, especially in patients who failed weaning, which are~     associated with a prolonged duration of mechanical ventilation. NAVA improves~     patient-ventilator synchrony, prevents excessive assist induced diaphragm inactivation. So~     the aim of this study was to detect that whether NAVA compared with PSV has the ability to~     reduce the duration of weaning in difficult to wean patients.~   "
135542|NCT01280747|"~     The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral~     neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher~     healthcare resource use and cost compared to patients without such restrictions on~     pregabalin in a naturalistic setting. The randomization will occur at the physician level~     and not the patient level.~   "
136484|NCT01268501|"~     The purpose of this trial is to evaluate the use of multifocal contact lenses in people who~     use reading glasses only.~   "
135545|NCT01280708|"~     The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation -~     Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement~     the medical and biological data of DIVAT existing cohort with parameters of surgical~     transplantation of kidney and pancreas. These data will concern the transplantation itself~     and the events and complications related to surgery occurring throughout the follow-up. The~     collection will involve patients in the cohort DIVAT and future patients. This project will~     allow us to have the sufficiency of surgical transplantation by increasing the quantity and~     quality of information gathered thus avoiding the biases commonly upbraided against the~     retrospective studies. Finally, by supplementing it with new parameters, it will strengthen~     the medical and scientific interest of the cohort DIVAT and will open new perspectives for~     clinical trials in surgery and work in epidemiology.Networking of urologists and the~     expansion of the base DIVAT would carry out research in epidemiology and factors that may~     play a role in the outcome of renal and pancreatic transplantation. It would also help to~     define good practices. The first study from the proposed network DIVAT-Uro is assessing the~     impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects~     on survival of the transplant in the recipient adult.~   "
135546|NCT01280695|"~     The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to~     evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.~   "
135547|NCT01280682|"~     Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease~     immune-mediated destruction of beta cells and result in preserved beta-cell function in~     patients with type 1 diabetes of recent onset.~   "
135548|NCT01280669|"~     The purpose of this study is to find out about the safety and effectiveness of two different~     doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The~     potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and~     yet avoid the potential complications that are usually associated with the systemic use of~     the drug and other immunomodulatory therapies. In this study, the investigators will~     administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or~     880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on~     the rest of the body. Therefore, it may offer a safer way than the current methods used to~     control the inflammation caused by non-infectious uveitis.~   "
135549|NCT01280656|"~     This retrospective study will assess the sustained virologic response and the safety of two~     different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data~     will be collected for 24 weeks.~   "
135550|NCT01280643|"~     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium,~     oxaliplatin, capecitabine, and irinotecan hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) and giving the drugs in different combinations~     may kill more tumor cells. Monoclonal antibodies, such as bevacizumab and cetuximab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to~     them. Giving combination chemotherapy together with bevacizumab or cetuximab may kill more~     tumor cells.~      PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase,~     ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens~   "
135551|NCT01280630|"~     TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of~     1 year in order to understand anti-thrombotic management patterns and outcomes of Acute~     Coronary Syndrome patients in India.~      This retrospective study is designed to provide a rapid and quick analysis of the existing~     database of ACS patients. So as to ensure quality check in the study, a pilot study will be~     conducted with around 500 patients at 10 centres across India and based on the meaningful~     results of the pilot study, full retrospective multi-centric study will be initiated at~     various selected centres across India. This study will use available registry data from a~     defined time period of Jan 2007-Dec 2009.~   "
135552|NCT01280617|"~     This is a planned single center prospective randomized study evaluating the safety and~     efficacy of low dose thymoglobulin as induction agent in renal transplant recipients.~     Inclusion criteria will be adult renal transplant recipients who are not sensitized against~     their potential donors. The patients who agree to participate in the study will be randomly~     assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will~     be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg~     dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially~     choose the sealed envelopes at the time of the patient randomization process. All patients~     will be started on our standard immunosupression regimen of prograf/cellcept and a fast~     steroid taper. Data will be obtained from every patient for up to one year post-transplant.~   "
135553|NCT01280604|"~     The primary objective of this randomized trial is to measure the impact of converting~     patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who~     continue fenofibrate 160mg per day for triglycerides.~   "
135554|NCT01280591|"~     The objective of the study is to evaluate the efficacy and safety of a single oral dose of~     two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that~     naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than~     either single ingredient alone in subjects with post-surgical dental pain and phase advanced~     sleep.~   "
135555|NCT01280578|"~     A prospective, single arm, multicenter clinical registry evaluating the change in migraine~     headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with~     the Coherex FlatStent™ EF PFO Closure System.~   "
135556|NCT01280565|"~     Masitinib is a novel TKI that potently inhibits wild type (WT) c-kit and its activated form,~     mutated in the juxtamembrane region (JM c-kit) PDGFRs, the intracellular kinase Lyn, and to~     a lesser extent fibroblast growth factor receptor 3 (FGFR3).~      Pre-clinical data suggest that masitinib is a strong candidate for the treatment of patients~     with advanced melanoma carrying a c-kit JM mutation.~   "
135651|NCT01279330|"~     The propose of this study is to assess the effect of general practitioner's involvement in~     the stimulus invitation letter in colorectal cancer screening compared to sending the~     patient home test (stimulus 2 of reference as contained in the specifications).~   "
135557|NCT01280552|"~     This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in~     treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an~     immunotherapy in which the patient's immune response will be stimulated to kill the tumor~     cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some~     of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with~     purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been~     exposed to the tumor antigens will then be given back to the patient as a vaccine over~     several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune~     response to kill the remaining GBM tumor cells after surgery and chemotherapy.~   "
135558|NCT01280539|"~     In this study the researchers want to investigate the effects of long-term transcutaneous~     electrical nerve stimulation on the cortical excitability of persons with multiple~     sclerosis.~   "
135559|NCT01280526|"~     This study is an open label, multicenter study with two phases:~        -  A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1~          without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and~          prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell~          lymphoma.~        -  An expansion phase in order to assess the safety and the efficacy of the association of~          the recommended dose of Romidepsin associated with CHOP in a population of patients~          with T-cell lymphoma.~   "
135560|NCT01280513|"~     The purpose of this study is to modulate the protein fermentation and to investigate the~     effect on colon toxicity.~   "
135561|NCT01280500|"~     The overall goal is to identify best practices for improving health outcomes for patients~     with asthma using comparative effectiveness research within an Agency for Healthcare~     Research and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be~     achieved by completing the following aims: (1) Create a centralized database for comparative~     effectiveness research on asthma by combining clinical and billing data from one of the~     largest healthcare systems in the country (Carolinas Healthcare System) with data from the~     school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully~     developed integrated approach to asthma management based on the Chronic Care Model; (3)~     Develop and implement a shared decision making approach for asthmatic patients from~     disadvantaged backgrounds; (4) Implement an electronic data collection system for an~     existing CDC funded school-based asthma intervention that will allow program evaluation and~     link school nurses with providers; (5) Evaluate and compare the effectiveness of these three~     asthma management strategies on: overall healthcare consumption and medical costs; quality~     of life, school absenteeism and performance; asthma clinical measures; and medication~     utilization; and (6) Disseminate findings across the state via the statewide PBRN and other~     network partners. This project has the potential to impact over 30,000 asthma patients~     across the Carolinas including many patients from disadvantaged backgrounds.~   "
135562|NCT01280487|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     preliminary efficacy of daily oral doses of ZSTK474, an oral phosphatidylinositol 3-kinase~     (PI3K) inhibitor, in subjects with advanced solid malignancies.~   "
135563|NCT01280474|"~     This study aims at investigating the effects of maternal depressive symptomatology on~     pregnancy outcomes and newborn development. How paternal psychopathology is involved in the~     association will also be explored.~      This is a three-year prospective cohort study. Three versions of questionnaires (the mother,~     the father, and the infant) will be developed first. For parents, data on self-reported~     symptomatology such as depression, anxiety, and stress will be collected, while for infants,~     maternal report on newborn development will be measured. Then, two medical centers and two~     regional hospitals will be selected. All pregnant women who undergo a first-trimester~     prenatal visit, who plan to carry the baby till term, and whose spouse is also willing to~     participate will be invited to join the study. The investigators expect to recruit a total~     of 194 pairs of depressive mothers and her spouses and 278 pairs of non-depressive mothers~     and her spouses in the study.~      After the informed consent is obtained, one baseline assessment (i.e., the first trimester)~     and four follow-up assessments (i.e., the second trimester, the third trimester, one month~     postnatal and six months postnatal) will be implemented. Basically, prenatal investigation~     (for both mothers and fathers) will be carried out at the outpatient prenatal visit.~     Postnatal investigation (for the mothers, fathers and infants) will be processed at the~     pediatric outpatient visit when the infants are schedule for an immunization injection.~     After data are collected, descriptive, analytic and longitudinal data analyses will be~     performed to investigate the association between parental psychopathology and pregnancy~     outcomes and newborn development.~      This study will explore the effects of the developmental trajectories of parental~     psychopathology on newborn growth during the critical stage of pregnancy. It is hoped that~     evidence based data could be obtained, examined, and applied in future~     prevention-intervention program to promote parental and newborn health, both physically and~     psychologically.~   "
135564|NCT01280461|"~     This is a phase III, multi-center, open-label, comparative and randomized study in~     evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the~     treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The~     investigator will determine the total duration of study therapy, as clinically indicated.~     The minimum duration of study therapy will be 7 days and the maximum allowable duration of~     study therapy will be 21 days.~   "
135565|NCT01280448|"~     Lung cancer is the leading cause of cancer deaths in Taiwan. The carcinogen in the~     environment is a key role in the development of lung cancer, and one of its main resource is~     tobacco. Activated carcinogens in the organism lead to mutations of crucial oncogenes~     resulting in tumor development. Genes such as Cytochrome P-450 family, GST (glutathione~     S-transferase) family, UGT (UDP-Glucuronosyltransferase) family, ERCC-1(excision repair~     cross-complementing rodent repair deficiency),ERCC-4 and ERCC-5,are encoding antioxidant~     enzymes or involving in the DNA repair process and the production of some transcription~     factors. In recent years, many studies have shown the correlation between these genes and~     the susceptibility of lung cancer. Each gene has a different role in the tumor development~     pathway. CYP, UGT, GST, NAT2 (N-acetyltransferase 2) and NQO1(NAD(P)H:quinono oxidoreductase~     1) involve in the production of antioxidant enzymes. The antioxidant enzymes can~     detoxificate hydrogen peroxide or defense against oxidative stress. However, the genetic~     polymorphisms may influence the function of detoxification, which cause the increase in the~     susceptibility of lung cancer. P53 and MDM2 genes play important roles in the production of~     tumor-suppression proteins and the regulation of transcription factors, which may regulate~     the growth and the apoptosis of cell cycle and influence the susceptibility of lug cancer.~     The polymorphisms in ERCC genes may cause the damage in the DNA repair process which might~     also cause increase in lung cancer susceptibility. The overexpression of epidermal growth~     factor receptor is highly correlated with increasing risk of the non-small cell lung~     cancers. The overexpression may induce the proliferation of cancer cells and the inhibition~     of the apatosis. Therefore, in recent years, EGFR has been widely studied as the new target~     of the drugs and the susceptibility of the lung cancer. In addition,the genetic~     polymorphisms in drug metabolism channel proteins, like OCT2 (organic cation transporter),~     ATP7A, ATP7B and ABC (ATP-binding cassette) transporter may have influence on the~     metabolism, the efficacy and the toxicity of the drugs.~   "
135652|NCT01279317|"~     The main objective of this study is to assess the acute effect of co-ingested vinegar on~     postprandial plasma glucose levels in type 2 diabetes patients.~   "
135653|NCT01279304|"~     The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in~     cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic~     axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy,~     breast surgery, and radiotherapy that is protocolized based on the pathology findings after~     chemotherapy and definitive surgery (ypTNM stage).~   "
135566|NCT01280435|"~     The trend is changed by a large number of low-cost computers, large-capacity computing~     power, and the rapid advent of network bandwidth. From the Internet to the WWW to Web2.0,~     the technology in addition brings impact on economic, social, and technological, but also on~     medical education about knowledge delivery globally and learning patterns.~      Currently, many scholars start to take the affection of social network seriously. In the~     medical field, ECGpedia is the typical successful example. There are more than 250,000~     members from 188 different countries in the website. On the other hand, the effect of data~     computing and transition improve the development of Gigapixel image presentation. For~     example, users can zoom in and zoom out on GoogleMap. The research team has being worked on~     this kind of search engine on pathology and anatomy slides in past three years. For~     education purpose, students can observe slides by using a virtual microscope directly.~      This research will target on establishing a Clinical Dermatopathology Online Discourse~     System (iSlide). It will combine a virtual microscope platform and a biopsy diagnosis~     eLearning System. This survey will be focused on evaluating of this platform. The object is~     all interns in dermatopathology department at Wan Fang Hospital this semester. All the new~     physicians can learn from experienced experts. Users who have questions can search for help~     from others via this website. They can get assistance by thinking procedure learning model~     -scheme inductive and pattern recognition. In doing so, clinicians and pathologists can~     discuss with each other through this system. It also can improve the education and research~     development in this field.~   "
135567|NCT01280422|"~     The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in~     foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which~     spent much time and money to establish could not use medicinal information to increase drug~     safety? One of the reasons which induced to override was that health care thought there were~     too much DDI alerts and high false alerts.~      The difference between DDI alert systems from pharmacists to confirm drug-drug interaction~     was that pharmacists not only confirmed ordering drug at the same time but also checked the~     other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems~     which were established by drug code alone would induce a lot of false alerts.~      In order to study how much false alert rate in drug-drug interactions, this research~     selected most common drug-drug interaction which was antacids and antibiotics. Antacids were~     most self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center,~     Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was~     to study how many drug-drug interactions and false alerts from antacids and antibiotics and~     analyze the difference in different department. Finally, proposing advice and assessment for~     building drug-drug interaction alerts system to strength drug information system and~     increase drug safety.~   "
135568|NCT01280409|"~     The purpose of this study is to determine whether the study drug metformin is helpful in~     reducing weight after pregnancy in women with gestational diabetes. This pilot study will~     provide information on how well women are able to take metformin postpartum, whether~     metformin increases weight loss, and whether there are any increased risks of side effects~     to you as a new mother.~   "
135569|NCT01280396|"~     Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as~     treatment for psychosis. There are increasing concerns about their related metabolic~     side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a~     specific condition known as metabolic syndrome. All these side-effects might be associated~     with the increased risk of cardiovascular diseases and diabetes mellitus.~      This study is to analyze the simple physical measurements (weight and height) and venous~     blood tests (for fasting blood glucose and lipid) results collected routinely since 2008~     (recommended by the local hospital authority as a territory-wide SGAs Monitoring Program)~     from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone,~     quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient~     clinic in Hong Kong. The investigators hypothesized that there should be differential risks~     on metabolic side-effects amongst these SGAs.~   "
135570|NCT01280383|"~     Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA~     delivers assistance to spontaneous breathing based on the detection of the electrical~     activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on~     respiratory muscle unloading critically ill patients.~   "
135571|NCT01280370|"~     Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland~     such meshes are mainly implanted via open or laparoscopic approach. The differential impact~     of these two types of surgical technique on recurrence rate will be investigated with this~     study.~      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia~     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.~      Hypothesis:~      Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to~     open incisional hernia repair.~   "
135572|NCT01280357|"~     Clinical Investigation Protocol for a study designed to determine the equivalence of the~     Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC)~     monitoring during labor. The study will be carried out on subjects in the first and second~     stages of labor.~   "
135573|NCT01280344|"~     Post-operative administration of ipamorelin is expected to reduce time to recovery of~     Gastrointestinal (GI) function in patients who have undergone partial small and/or large~     bowel resection.~   "
135574|NCT01280331|"~     This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003~     12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg~     given q6hr for the management of acute moderate to severe postoperative pain for 48 hours~     following bunionectomy surgery.~   "
135575|NCT01280318|"~     The obvious hypothesis is that the application of peri-operative targeted biological agents~     may counteract the tumor growth effect of these circulating factors and improve patient~     outcome~   "
135576|NCT01280305|"~     The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as~     add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.~   "
135654|NCT01279291|"~     This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as~     monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in~     subjects platinum-sensitive and platinum-resistant ovarian cancer.~   "
135577|NCT01280292|"~     Medical management of central hypothyroidism is controversial due to lack of reference for~     evaluation of pituitary negative feedback. Therefore, titration of medical treatment is~     based on T4 levels, measured with variable laboratory methods. Patients who have central~     hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which~     they need replacement therapy such as steroids, testosterone and growth hormone. This~     combined hormone deficiency makes clinical and laboratory evaluation challenging among these~     patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific~     and it might be overlooked due to other hormonal deficiencies. Replacement therapy for~     central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th~     percentile of normal. The goal of our study is to compare the standard results from well~     known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem~     mass spectrometry.~   "
135578|NCT01280279|"~     Few studies have reported the efficacy of repetitive education for behavioral modification~     as the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study~     is to investigate the efficacy of repetitive education for behavioral modification as the~     first-line therapy in the patients with NPU and to show whether a single education for~     behavioral modification is sufficient for the patients.~   "
135579|NCT01280266|"~     The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin~     discoloration, is 5-10% in general population. Often conventional measures such as warming~     up or minimizing exposure to cold are not enough and many patients require treatment with a~     vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil,~     a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.~      Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5~     inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment~     of secondary RP in Korean patients.~   "
135580|NCT01280253|"~     The objective of the study is to identify biochemical predictors of morbidity and mortality~     in patients suffering from hip fracture. For this purpose blood samples are collected~     prehospitally or in the emergency department in patients with a suspected hip fracture.~     During the hospital stay medical history, anesthesiological management recorded. In~     addition, american society of anesthesiology physiological score (ASA), revised cardiac risk~     index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded  in~     house, after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome~     will be evaluated with logistic regression analysis. Biochemical predictors include~     pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin~     c. The predictive value of the potential markers will be compared to that of ASA, RCRI and~     POSSUM.~   "
135581|NCT01280240|"~     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000~     (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced~     anemia.~   "
135582|NCT01280227|"~     Children with Cancer or congenital heart disease (CHD) experience complex, physical,~     psychosocial and behavioural symptoms and problems due to the illness, treatment, and~     medical procedures. To help children cope with their problems and prevent psychological~     distress, the investigators developed SiSom, a support system to help children with cancer~     or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable~     computer.~      This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the~     following hypotheses: When children use SiSom to report their symptoms and problems, and~     this information is provided to their clinicians in their outpatient consultations:~        -  Children and parents will experience less anxiety.~        -  Children and parents will be more satisfied with the outpatient visit.~        -  There will be greater congruence between children's reported symptoms and problems and~          those addressed by their clinicians as evidenced in documented patient care.~      To better understand the mechanisms by which these effects may occur, the investigators will~     also explore:~        -  Differences between control and experimental groups in patient-provider communication~          in terms of instrumental and affective behaviour, participation, initiative and person~          addressed;~        -  The relationships among outcomes of patient-provider communication, congruence between~          patients' reported symptoms and those addressed by their clinicians and children's and~          parents' anxiety and satisfaction; and how these relationships differ between treatment~          and control conditions.~      Finally, the investigators will investigate time requirements, ease of use and usefulness of~     SiSom by children and clinicians.~      For analyses the investigators will use inferential statistics and qualitative analyses of~     the video-taped consultation sessions. This study will contribute to improving~     patient-centred care for a particularly vulnerable population, and to a better understanding~     of the triadic communication and interactions among child-parent and clinician.~   "
135583|NCT01280214|"~     Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to~     systemic Steroid therapy for patients with active thyroid orbitopathy.~   "
135584|NCT01280201|"~     The incidence of new diagnosed patients with NET of the digestive tract including carcinoid~     and pancreatic islet cells tumors ranges from 2 to 10 per 100,000 in the western Countries~     (Kulke M, Mayer R. N Engl J Med 340:858-868, 1999). Despite of the low incidence, the~     prevalence of these tumors is high because of their relatively long survival estimated in~     35% at 5 years for those patients with well or moderate differentiated tumors (Yao JC, et~     al. J Clin Oncol. 2008;26:3063-3072). In fact, digestive NETs are the second most prevalent~     tumors derived from the digestive tract after colorectal carcinoma.~      NETs are characterized by abundant vasculature, moreover VEGFR and VEGFR are overexpressed~     in 60-84% of the carcinoids and pancreatic islet cells NETs (Zhang et al. Cancer~     2007;109:1478-1486). Other pro-angiogenic factors like the platelet derived growth factor~     (PDGFR) have been also involved in NET progression and development (Chaudhry A, et al.Cancer~     Res 1992;52:1006-12).~      Pazopanib is an oral tyrosine kinase inhibitor of the VEGFR, PDGFR and KIT with a dual~     activity both as an antiangiogenic and also and anti-tumoral agent (Kumar et al. Mol Cancer~     Ther2007;6:2012-2021, Hurwitz et al. Clin Cancer Res 2009;15:4220-4227). Pazopanib seems to~     have a better toxicity profile versus the other antiangiogenic tyrosine kinase inhibitors~     and has already shown activity in several tumor types like renal cell carcinoma (Sternberg~     et al. J Clin Oncol 2009;27:abst. 5021), soft tissue sarcomas (Sleijfer et al. J Clin Oncol~     2009;27:3126-32), hepatocellular carcinoma (Yau et al. J Clin Oncol 2009;27:abst. 3561),~     colorectal cancer (Brady et al. J Clin Oncol 2009;27:abst.4133), and thyroid cancers (Bible~     et al. J Clin Oncol 2009;27:abst. 3521).~      The Spanish Group for Research in Neuroendocrine Tumors (GETNE) group is an active Member~     inside of the GENET group and has a large tradition in clinical trials in NETs. The~     investigators hypothesize that pazopanib may have at least as good activity and better~     safety profile than other VEGFR inhibitors in progressive advanced or metastatic NET tumors~     derived from the digestive tract.~   "
135585|NCT01280188|"~     This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI)~     patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of~     desmopressin.~   "
135586|NCT01280175|"~     The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite~     beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol~     100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique~     or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the~     standard actuator~   "
135587|NCT01280162|"~     An observational cohort and malaria treatment study in Cambodia.~   "
135588|NCT01280149|"~     The purpose of this study is to determine whether a neuropeptide, substance P, when injected~     along with an allergen, such as ragweed, can reduce allergic reactivity.~   "
135589|NCT01280136|"~     The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually~     transmitted infection (STI), and pregnancy prevention curriculum as a stand alone~     intervention for 8th grade students in a large urban school district. This web-based~     curriculum will be adapted from the computer-based component of an existing successful~     prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include~     critical elements from the IYG classroom component. The primary hypothesis to be tested is:~     (1) students who receive the web-based curriculum will delay sexual activity relative to~     those who receive standard care. The major dependent variable is the proportion of students~     initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine~     the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal)~     and psychosocial variables such as students' intentions, knowledge, self-efficacy,~     attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses~     will also examine the effect of the intervention on the proportion of students who are~     sexually active, number of times students engage in unprotected sexual intercourse, and~     students' number of sexual partners.~   "
135590|NCT01280123|"~     This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of~     oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and~     futility.~      Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least~     8 weeks but no more than 8 months, will be randomized to one of two dosages of oral~     pioglitazone (15 mg and 45 mg) or matching placebo.~      The study will measure disease progression by the change in total Unified Parkinson's~     Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.~   "
135591|NCT01280110|"~     BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium~     salt with surfactant qualities. It can be bacteriostatic or bactericidal depending on the~     concentrations used. It has been shown to be effective against most bacteria with a few~     exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in~     eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various~     other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first~     introduced because it also enhances corneal penetration of some drugs by causing epithelial~     separation.~      It is present in several ophthalmic formulations, including most of the antiglaucoma~     medications. If used chronically, BAK has been found to cause ocular surface changes, such~     as dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the~     blood aqueous barrier, which may lead to undesirable consequences, such as uveitis and~     cystoid macular edema. However, this information is controversial. The purpose of this study~     is to evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of~     pseudophakic patients receiving BAK-preserved lubricating drops.~   "
135592|NCT01280097|"~     The investigators will perform a prospective, cohort study of 100 older intensive care unit~     (ICU) patients, to investigate the association between sleep disruption and ICU delirium.~   "
135593|NCT01280084|"~     This study aims to measure movements in babies after they are born using an actigraph, a~     wristwatch-sized device worn on the ankle, which works similarly to the device used by~     runners to count the number of steps they have taken. We aim to compare the movements of~     babies whose mothers have received different types of pain relief in labour.~   "
135594|NCT01280071|"~     Veno-arteriolar and veno- arteriolar-myogenic reflexes (VAR and VMR, respectively) are of~     the most important contributors to local vasoregulation.~      In a recent research we showed that VAR is affected in the affected lower limbs of CRPS~     (chronic regional pain syndrome) patients. {Dayan, 2008 1 /id} That is, local venous~     congestion (40 mmHg) results in a decreased blood flow in the affected, sick limb compared~     with its contralateral. The myogenic reflex, however, that is induced by lowering the leg 40~     cm below heart level, which causes both venous and arteriolar congestion, was intact in the~     sick leg. We concluded that the pathophysiology of CRPS might involve a defect in the neural~     reflex between venous and arteriolar vessels. Arteriolar smooth muscle action, on the other~     hand, is intact and might compensate for the overwhelmed VAR.~      Trying to explain the fact that VAR, but not VMR, was different between the affected and~     unaffected limbs, we raise the hypothesis that since VMR is a local vasoregulatory reflex~     composed of two components: the venous and myogenic, opposed to the VAR, the myogenoic~     component of the reflex might compensate for the inappropriate VAR. Many mechanisms that~     might affect vascular muscles may occur, one of them is related to adenosine.~      Adenosine is considered a retaliatory autacoid, whose main function is to protect tissues~     against ischemia. It is a very potent vasodilator. Adenosine is also considered an important~     mediator of ischemic preconditioning, a phenomenon by which an initial brief period of~     ischemia protects the tissue from the damage produced by a subsequent more intense ischemic~     episode.~      Adenosine has a pivotal role in local vasoregulation. In many researches it was shown that~     adenosine contributes to exercise hyperaemia in skeletal muscle. The 'adenosine hypothesis'~     states that blood flow is regulated by interstitial adenosine, released from cardiac or~     skeletal muscle fibers when there is a mismatch between O2 supply and O2 demand. When there~     is insufficient O2 to regenerate ATP, ADP and AMP accumulate leading to adenosine~     generation. By causing vasodilatation, adenosine helps to restore the O2 delivery, reversing~     the mismatch and allowing ATP to be regenerated.~      Adenosine is a naturally occurring ligand of 4 subtypes of G-protein-coupled cell membrane~     receptors (A1, A2A, A2B, and A3) involved in cellular signaling. Dipyridamole produces~     coronary hyperemia by indirectly activating adenosine A2A receptors by inhibiting tissue~     uptake of adenosine and thereby increasing levels of endogenous adenosine.~      Taking all these considerations into account we hypothesize that local vascular reflexes~     like VAR, and eventually VMR are mediated by adenosine. That is, adenosine produced at a~     constant rate in vascular bed contributing to constant blood flow under a wide range of~     local circumstances. A local increase in venous blood flow (as in lower limbs veins during~     prolonged standing) causes adenosine wash out, which leads to local arterial~     vasoconstriction to reduce blood flow to the limb, which is, in fact, the purpose of VAR. if~     our hypothesis turns to be true, then when we will see exaggeration of the reflexes with~     adenosine blockade and vice versa, a decrease its abolishment with adenosine reuptake~     inhibition.~   "
135595|NCT01280058|"~     This phase II trial studies how well carboplatin and paclitaxel with or without viral~     therapy works in treating patients with pancreatic cancer that has come back or has spread~     to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Viral therapy may be able~     to kill tumor cells without damaging normal cells. It is not yet known whether carboplatin~     and paclitaxel are more effective with or without viral therapy in treating pancreatic~     cancer.~   "
135596|NCT01280045|"~     The investigators aimed to assess if use of aromatase inhibitors could decrease volume of~     uterine leiomyoma and cause same percentage of adverse effects during its use compared to~     GnRH analogs.~   "
135597|NCT01280032|"~     Vertebral column is the most prevalent location of bone metastases. Besides axial pain,~     vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord~     compression. Although the median overall survival of patients with bone metastases is only~     7-9 month, half of them live longer and will require palliative treatment for their~     symptoms.~      Treatment options are radiotherapy and /or surgical treatment such as laminectomy,~     vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative~     external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or~     radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover~     many patients present visceral and bone metastases simultaneously and require urgent~     systemic therapy. However, due to potentiated toxicity, concurrent therapy with full dose~     chemotherapy and radiotherapy is rarely possible.~      The investigators have therefore established a novel method for intraoperative radiotherapy~     (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis~     and immediate initiation of chemotherapy.~      The kyphoplasty itself is performed according to the standard procedure with some minor~     modifications. In short under general anaesthesia, a bipedicular approach into the affected~     vertebra is chosen with insertion of specially designed metallic sleeves to guide the~     electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT~     during a kyphoplasty with this device a new applicator was designed. This sterile applicator~     consists of a plastic head, which is needed to attach it to the X-ray source and a stainless~     steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the~     applicator including the drift tube is guided through the metallic sleeves in the vertebral~     body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is~     removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the~     sleeves are removed and the wound is closed as usual.~      Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a~     kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined~     treatment procedure. To determine the MTD 3 levels with increasing doses are planned:~      8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.~   "
135598|NCT01280019|"~     In ventilated patients with acute respiratory failure endotracheal suctioning may lead to~     alveolar derecruitment, which can be monitored by means of functional residual capacity~     (FRC) measurements. Regional distribution of ventilation can be followed at bedside using~     electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment~     strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning,~     improves oxygenation and regional distribution of ventilation. In addition the investigators~     research the impact of such a strategy on the inflammatory response to mechanical~     ventilation.~   "
135599|NCT01280006|"~     The study has been designed to assess the effect of cyclooxygenase inhibition on blood~     pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic~     intermittent hypoxia exposure.~   "
135600|NCT01279993|"~     Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy~     (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who~     were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations~     were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had~     esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance~     exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative~     exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed~     postoperative near exotropia. A significant reduction in means of convergence and divergence~     amplitudes (P<0.001) and a meaningful increase in mean of near point of convergence (NPC)~     (P<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD~     in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had~     an preoperative NPC>10 cm which was not changed by the surgery. Out of 9 (6%) patients with~     baseline stereopsis >60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis~     following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye~     deviation in patients undergoing PRK may improve or remain unchanged after operation and~     postoperative deviations can develop following this surgery. Diminishing of fusional~     amplitude and increasing of NPC as well as improving of stereopsis may also happen after~     PRK. Therefore, a preoperative orthoptic examination in patients with any concerning~     histories and/or motility issues on routine exam is recommended before performing PRK.~   "
135601|NCT01279980|"~     The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic~     wound catheter) can be used instead of epidurals for patients having bowel surgery in an~     enhanced recovery programme. The investigators want to find out whether or not using this~     device means people need to stay in hospital for less time after surgery.~   "
135602|NCT01279967|"~     To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted~     therapy in patients with ASS-negative malignant pleural mesothelioma.~   "
135603|NCT01279954|"~     The purpose of this study is to assess the safety and efficacy of abatacept in the treatment~     of uveitis.~   "
135604|NCT01279941|"~     Researchers from Oregon Health & Science University have developed a science-based,~     team-centered, scripted peer-taught program for fire fighters improving diet and exercise~     behavior while reducing injury rates and costs. Those investigators are partnering with~     local law enforcement agencies in Oregon and SW Washington to adapt, apply and assess this~     work-based program among a new high risk group to improve the health and safety of law~     enforcement officers (LEOs). Fire fighters' work structure is a natural fit for a~     team-centered format, and teammates' social support appeared to partially mediate the~     intervention's positive outcomes. Although conducive to team formation, LEOs' work lacks the~     established team structure of fire fighters. This proposal will apply the team-centered~     intervention to LEOs and in the process, learn more about teams as vehicles of health~     behavior change, and their relationship with outcomes and other potential mediating~     variables in a multilevel ecological analytic framework.~   "
135605|NCT01279928|"~     This project aimed to explore novel methods of detecting small blood vessel disease in a~     paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold~     capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory~     Blood Pressure Monitoring were used. Each of these techniques investigated different areas~     of small blood vessels around the body.~      It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel~     investigations would be associated with small blood vessel disease and that widespread~     changes to these blood vessels would be detected through associations between the different~     novel investigations.~   "
135606|NCT01279915|"~     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     single ascending dose of ASP0456 in non-elderly healthy subjects.~   "
135607|NCT01279902|"~     This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with~     completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage~     I or II.~   "
135608|NCT01279889|"~     This study aims to identify women at risk of low blood pressure (hypotension) after the~     usual cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration.~     We believe we can predict who will get hypotension by using two anesthesia monitors together~     with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will~     cause a shift of blood from the legs to the heart, and the monitors will detect the heart's~     response to tell if a subject is dehydrated. We want to see if these dehydration tests can~     also predict hypotension after a spinal anesthetic.~   "
135609|NCT01279876|"~     The purpose of this study is to determine whether melatonin is effective in the treatment of~     relapsing-remitting multiple sclerosis patients as a supplement to the main~     disease-modifying drugs.~   "
135610|NCT01279863|"~     The VRI technology provides a radiation free dynamic image of the lung, by using a~     combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm.~     The aim of the study is to determine if the VRI examination may contribute to the diagnosis~     and follow up of pneumonia in children, and therefore reduce the number of chest radiographs~     and the exposure to ionizing radiation. Children referred by ED for chest x-ray,for the~     evaluation of pneumonia, will undergo VRI as well. The two modalities will be read~     independently and then the findings will be compared, in order to asses the potential role~     of the VRI to the management of pneumonia in children.~   "
135611|NCT01279850|"~     The objective of this investigation is to evaluate the safety and efficacy of long term use~     with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug~     reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period,~     and whether an additional treatment outcome investigation and/or a post-marketing clinical~     study is required in the future will be determined.~   "
135655|NCT01279278|"~     The propose of this study is to assess the effect of general practitioner's involvement on~     first patients' solicitation in screening for colorectal cancer by testing for faecal occult~     blood (FOBT).~   "
135673|NCT01279044|"~     The purpose of this study is to determine if persons randomized to receive adapted~     Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in~     unprotected anal sex behavior compared with persons who do not receive Personalized~     Cognitive Risk-reduction Counseling (PCC).~   "
135612|NCT01279837|"~     In this study supported by an American Cancer Society grant, the investigators are~     evaluating two levels of swallowing exercise intensity on the maintenance of swallowing~     muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in~     this study are randomly placed into different exercise groups and provided with exercises to~     perform daily during their radiation treatment. Their progress, diet management and~     swallowing ability are monitored throughout the treatment period and followed up until 3~     months after radiation treatment. In addition to the daily treatment details, the patients~     perception of their swallowing ability and concerns about their health and treatment are~     also measured. This clinical trial will help to refine a previously investigated simple~     exercise package and provide a program of intervention that can help prevent medically~     related complications of swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube~     feeding), and improve the ability to eat for patients with head / neck cancer. Ultimately it~     is hoped that this form of exercise therapy will help reduce the costs (personal and~     financial) to the patient, caregivers and community.~   "
135613|NCT01279824|"~     Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for~     the treatment of dysphagia post stroke and is clinically receiving favor as a treatment~     modality, in the absence of strong research support. This study aims to investigate the~     effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke.~     The study will follow a pilot randomized controlled trial design. Fifty one patients~     admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia,~     and randomized into one of three groups, NMES, sham NMES or usual care -behavioral~     swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and~     their progress and outcome will be monitored. The results will add to the preliminary data~     on the effectiveness of this form of swallowing treatment for patients following stroke, and~     has the potential to enable more efficient allocation of resources to post-acute~     rehabilitation and thus benefit afforded to stroke patients, and the community.~   "
135614|NCT01279811|"~     The purpose of this study is to:~        1. Measure the pressure in the spinal fluid surrounding the spinal cord to find out how~          well the spinal cord is being supplied with blood.~        2. Determine how drugs called vasopressors, which are used to control blood pressure~          following SCI (spinal cord injury), influence spinal fluid pressure.~        3. Characterize the severity of an SCI using the levels of specific proteins found within~          the spinal fluid.~        4. Predict how much neurologic recovery may be regained using the levels of specific~          proteins within your spinal fluid.~        5. Identify proteins within the spinal fluid that will help us learn more about what is~          happening after SCI and assist us in developing new treatments for SCI.~   "
135615|NCT01279798|"~     This is an expanded access protocol designed to make Lucanix® available to subjects with~     advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol,~     NR001-03. A total of 45 patients will be enrolled into the study.~   "
135616|NCT01279785|"~     This is a single arm, open label study of up to 20 patients with prostate cancer scheduled~     for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for~     visible uptake and compared with histopathology.~   "
135617|NCT01279772|"~     In this study, the investigators propose that the addition of rituximab will lower the risk~     of systemic and local relapses in patients with localized PBL. Patients will be treated with~     6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy~     is strongly recommended, based on the findings of the retrospective IELSG study, but will be~     at the discretion of the treating center.~   "
135618|NCT01279759|"~     Background:~      An estimated 4000 Anterior Cruciate Ligament Injuries (ACL) occur annually in Norway (Granan~     et al., 2004). 1630 primary ACL reconstructions were performed in Norway in 2008 (Norwegian~     Arthroplasty Register, 2009). Approximately 120 of these ACL reconstructions were performed~     at Haraldsplass Deaconess Hospital.~      Physical therapists at our hospital are responsible for postoperative outpatient controls of~     patients with a reconstructed anterior cruciate ligament. A clinical observation is that~     stair walking (especially downstairs) may be problematic up to 6 months after ACL~     reconstruction. One reason may be that the quadriceps muscle is unable to control the knee~     when the subject is walking downstairs, and that the knee is perceived to be unstable. Other~     contributing factors may be pain and swelling.~      It is of interest to know which pre and post operative factors can predict measured and~     patient reported function 6 months after ACL reconstruction. Previous research shows that~     predictive factors for clinical outcome after ACL reconstruction are anterior knee pain~     (Heijne et al., 2009), preoperative electromyography, early postoperative strength (McHugh~     et al., 2002), preoperative quadriceps muscle strength deficits, meniscus injury and pain~     (Eitzen et al., 2009), obesity, smoking and serious chondrosis (Kowalchuk et al., 2009).~      Purpose:~        1. To analyse which pre and post operative factors can predict measured and patient~          reported function 6 months after Anterior Cruciate Ligament reconstruction.~        2. To investigate if there is an asymmetry in step time between the affected and~          unaffected leg during down stairs walking, and if degree of asymmetry decreases during~          a 6 months period post operatively. Further we want to compare step time asymmetry with~          other established outcome measures to investigate sensitivity to change over the~          observation period and also compare the patient group in this study with a control~          group of healthy subjects to see if asymmetry in the patient group after 6 months is~          still higher than in healthy subjects.~   "
135619|NCT01279746|"~     The purpose of this study is to prove that bedside Ultrasound Compression is a useful~     screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to~     the emergency room with hypoxia.~   "
135620|NCT01279733|"~     The main objective of the multi-centered collaborative study is to evaluate the accuracy,~     efficacy and clinical advantages of prenatal diagnosis using microarray analysis as compared~     with conventional karyotyping.~   "
135621|NCT01279720|"~     Adenosine deaminase deficiency is an inherited disorder that results in severe abnormalities~     of the immune system and leaves children unable to fight infection. This trial aims to treat~     adenosine deaminase deficiency patients using gene therapy.~   "
135649|NCT01279356|"~     Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease~     (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally~     hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important~     since progression is likely and is associated with significant morbidity and mortality.~     However, in daily clinical practice no specific and non-invasive biomarkers are used for the~     diagnosis and follow-up of patients with liver diseases. It is known that patients with~     liver diseases produce compounds that can be excreted in breath as a consequence of~     metabolic processes, inflammation and/or oxidative stress. These are called volatile organic~     compounds (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable~     information in patients with chronic obstructive lung disease (COPD) and inflammatory bowel~     disease (IBD). Also, in patients with liver disease, exhaled VOCs have been detected.~      The investigators hypothesize that analysis of VOCs in exhaled air of patients with liver~     diseases can be used for diagnosis and follow-up.~   "
135622|NCT01279707|"~     The treatment of adult B-cell acute lymphoblastic leukaemia (ALL) has progressed~     considerably in the past 3 decades, particularly due to intensification of chemotherapies,~     improved supportive care and the incorporation of stem cell transplantation. However, the~     maximum tolerability of standard chemotherapeutics has been reached in ALL. Using~     conventional chemotherapy, 80-85% of adults with ALL will achieve a complete remission (CR).~     Unfortunately treatment at relapse is generally unsuccessful and rarely results, in~     long-term survival (7% survival at 5 years). Therefore, the investigators are exploring~     novel treatment strategies through the use of monoclonal antibodies (MoAbs) directed at~     surface antigens on leukaemic blasts. Using MoAbs directed against surface proteins on B~     cells has had excellent results in other B-cell diseases such as low and high grade~     non-Hodgkin lymphomas, without additional toxicity. There has also been limited evidence~     from small studies and case reports of the efficacy of MoAbs in ALL.~      This is a Phase I/II study to determine the safety and tolerability of the combination of~     veltuzumab and epratuzumab with intensive chemotherapy in patients with relapsed B-cell ALL.~     A maximum of 51 patients will be treated with a combination of UKALL XII induction~     chemotherapy and the monoclonal antibodies veltuzumab and epratuzumab. Veltuzumab and~     epratuzumab are humanised monoclonal antibodies that target CD20 and CD22 surface proteins,~     respectively. Both of these proteins are expressed on ALL tumour B cells.~      One group of patients will receive modified UKALL XII chemotherapy + veltuzumab; a second,~     modified UKALL XII chemotherapy + epratuzumab and if limited toxicity is found in these~     first 2 groups, a third group will receive, modified UKALL XII chemotherapy + both~     veltuzumab and epratuzumab. Patients will be assessed for safety, tolerability and disease~     response. Safety and tolerability will be measured by the number of Dose Limiting Toxicities~     (DLTs) in each group. Disease response will be measured by the microscopic appearance of~     patient bone marrow samples at day 29, and by molecular tests for tumour cells in bone~     marrow.~   "
135623|NCT01279694|"~     Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients~     with multiple myeloma. Nine: University Hospital of Nantes, University Hospital of Nancy,~     University Hospital of Lille, University Hospital of Tours, department Hospital of La Roche~     Sur Yon, University Hospital of Reims, University Hospital of Clermont-Ferrand, University~     Hospital of Toulouse, University Hospital of Dijon Newly diagnosed symptomatic Multiple~     Myeloma > 65 years. Treatment comprises an initial phase consisting of nine 6-week cycles of~     Carfilzomib on Days 1, 2, 8, 9, 22, 23, 29, 30 (carfilzomib is administered at 20 mg/m2 on~     Days 1 and 2 of the first cycle and 20, 27, 36 or 45 mg/m2 thereafter) followed by a 12 day~     rest period (42-day cycle), in combination with oral Melphalan 9 mg/m² and oral prednisone~     60mg/m², both on days 1 to 4.~      Phase I: Identification of Maximum Tolerated Dose (MTD)~      Carfilzomib will be administered at a dose of 20mg/m² for all doses to the first cohort of 6~     patients. If dose-limiting toxicities (DLTs) occurred in fewer than 2 of these patients, the~     next cohort of 6 patients (cohort 2) will receive a dose of 20/27 mg/m² where the 20 mg/m²~     dose is administered on Day 1 and 2 of Cycle 1 only and then 27 mg/m² for all subsequent~     doses. If DLTs occurred in fewer than 2 of the patients in cohort 2, the third cohort of 6~     patients will receive a dose of 20/36 mg/m² where the 20 mg/m² dose is administered on Day 1~     and 2 of Cycle 1 only and then 36 mg/m² for all subsequent doses. If DLTs occurred in fewer~     than 3 of the patients in cohort 3 the fourth cohort of 6 patients will receive a dose of~     20/45 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then~     45 mg/m² for all subsequent doses. If at any time during cycle 1 of a dose cohort, ≥ 2~     subjects experience a drug-related DLT, the MTD will have been exceeded, additional~     enrollment within the cohort will cease, and dose escalation will stop. The MTD will be~     defined as the dose level below which DLT is observed in ≥ 33% (i.e. ≥ 2 of 6) subjects in a~     cohort. The following are defined as DLTs:~        -  Any hematologic toxicity of grade 4 intensity or preventing administration of 2 or more~          of the 8 carfilzomib doses of the first treatment cycle except a) grade 4~          thrombocytopenia without bleeding lasting ≤ 7 days or b) grade 4 neutropenia lasting ≤~          7 days~        -  Grade ≥ 3 febrile neutropenia~        -  Grade ≥ 3 gastrointestinal toxicities (except for grade ≥ 3 nausea/ vomiting if the~          patient had not received adequate antiemetic prophylaxis)~        -  Any other grade ≥ 3 nonhematologic toxicity considered related to CMP by the principal~          investigator.~        -  Grade ≥ 3 peripheral neuropathy persisting for more than 3 weeks after discontinuation~          of study drugs.~      Adverse events (AEs) will be graded according to National Cancer Institute Common~     Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). MTD determination will be~     based on occurrence of DLTs during the first induction treatment cycle only.~      Phase II: Expanded Cohort. After identification of the MTD, it is planned for the dose~     cohort to be expanded to include up to a total of 20 patients treated at the MTD for the~     phase II part of the study. A full treatment course is the same as for phase I: nine 6-week~     cycles of CMP.~      PRIMARY ENDPOINT Phase I: MTD of combination Phase II: Overall response rate [(ORR),~     consisting of complete response (CR), very good partial response (VGPR), and partial~     response (PR) SECONDARY ENDPOINTS Safety and tolerability of CMP Clinical benefit response~     [(CBR = ORR + minimal response (MR)], Progression-free survival (PFS), Duration of response~     Overall survival (OS). Safety data analysis will be conducted on all subjects receiving at~     least one dose of study treatment. Analyses will consist of data summaries for reported AEs.~     The number and percentage of subjects experiencing one or more AEs will be summarized by~     dose, relationship to study drugs, and severity. AEs will be coded using MedDRA terminology.~      Disease Response Analyses: Overall response rate (ORR = CR + VGPR + PR) to treatment will be~     measured using the International Myeloma Working Group (IMWG) criteria. Clinical benefit~     response (CBR = ORR + MR) will be determined using minimal response (at least 6 weeks~     duration) as defined by the European Group for Blood and Marrow Transplant (EBMT). The~     distribution of subjects by response category will be made overall and by dose cohort.~     Time-to-event endpoints will be evaluated with the use of the Kaplan-Meier method and plots~     will be provided. Analysis of time-to-event outcomes will be performed for the overall~     sample.~   "
135624|NCT01279681|"~     This randomized phase III trial studies how well combination chemotherapy plus bevacizumab~     with or without oxaliplatin works in treating older patients with colorectal cancer that has~     spread to other places in the body. Drugs used in chemotherapy work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~     Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by~     targeting certain cells. Bevacizumab may also stop the growth of cancer by blocking blood~     flow to the tumor. It is not yet known whether combination chemotherapy plus bevacizumab is~     more effective with or without oxaliplatin in treating colorectal cancer.~   "
135625|NCT01279668|"~     Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient~     chest clinics. Most coughs are caused by self-limiting viral infections such as the common~     cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go~     on for several weeks. Whooping cough is a common cause of persistent cough in young people~     and adults. Although the whooping cough vaccine gives lifelong protection against severe~     infection, it does not appear to give such long-term protection against milder infections,~     which can make someone cough for many weeks. There are currently no proven efficacious~     treatments for persistent cough following either a viral infection or infection with~     whooping cough.~      Montelukast is a medication which is already licensed for the treatment of asthma. It works~     by blocking the action of chemicals called leukotrienes, which make the airways of people~     with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes~     are also involved in causing persistent cough following viral or whooping cough infection.~     Montelukast may therefore also help settle persistent coughs in these settings.~      Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks~     from general practices in England. An oral fluid sample will be taken from each participant~     to be tested for whooping cough. Participants will be randomly allocated to receive a 28-day~     course of montelukast or placebo tablets and asked to complete a daily cough diary for two~     weeks. They will be assessed after two weeks by their GP (face-to-face) and after four weeks~     by another member of practice clinical staff (telephone). Some participants will be given a~     24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be~     funded by the National Institute for Health Research's School of Primary Care.~   "
135626|NCT01279655|"~     In the current study the researchers will firstly investigate whether a bimanual~     coordination training protocol (20 min/day, for 8 consecutive weeks) correlates with changes~     in white matter architecture and improved upper-limb functionality in patients with multiple~     sclerosis. Secondly, the researchers predict that motor learning is more efficient when it~     is combined with anodal transcranial direct current (tDCS) stimulation on the left primary~     motor cortex.~   "
135627|NCT01279642|"~     Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and~     placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or~     traditional method; to identify the influence of the DUVS in the time expended to PICC~     placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits~     of research endorsement and the obtaining of consent for those responsible for the children.~     The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into~     two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes~     Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney~     tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21~     (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG~     and in 47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children~     of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was~     significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).~   "
135628|NCT01279629|"~     The purpose of this study is:~      To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.~      - Population:~      50 patients will be selected from both sexes, healthy, between 18 and 65 years with a~     clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of~     inclusion and exclusion.~   "
135629|NCT01279616|"~     Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell~     disease lack a matched family donor. This study aims for cure of sickle cell disease by~     performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood~     units will be selected from the NMDP database. It is designed to estimate the safety of a~     novel reduced toxicity, yet an immunosuppressive and myeloablative preparative regimen. This~     is meant for patients <21 years old who have severe complications from sickle cell and do~     not have matched sibling donors in the family to undergo stem cell transplant. Patients will~     undergo transplant using unrelated donor stem cells after receiving the protocol therapy.~     They will be followed for 1 year to monitor for engraftment of donor cells and complications~     like graft versus host disease (GVHD), infections and death.~   "
135630|NCT01279603|"~     This clinical trial is about testing GO-203-2c, which is a newly discovered compound that~     binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in~     many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in~     laboratory studies.~      This study is being done to:~        -  Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your~          cancer~        -  Find the highest dose of GO-203-2c that can be given without causing bad side effects~        -  Examine how much GO-203-2c is in the blood at certain times after it is given and how~          quickly the body gets rid of it~        -  Observe whether there is any effect of GO-203-2c on the size and activity of cancer in~          your body~   "
135633|NCT01279564|"~     Airway management is one of the most important tasks facing the physician, especially the~     anesthesiologist. Fast and correct performance of endotracheal intubations done as normal~     routine in the operating room, but can save life everywhere.~      To make intubation easier, several newly designed tubes and laryngoscopes are developed and~     tested every year. Their performance is evaluated subjectively by the acting~     anesthesiologist, and by using objective parameters such as speed of intubation, the force~     applied during laryngoscopy , or catecholamines secretion during intubation as a stress~     parameter . The studies set for testing these parameters lead to establish accepted~     indications for the treatment of the airway in cases of anticipated and unanticipated~     difficult airway.~      In the present study we will compare the performance parameters of intubation using Etview~     Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily~     intubations are carried with. The Etview TVT is similar to the standard endotracheal tube;~     its outer dimensions and material is exactly as the standard tube, the difference is only~     the inner fiber of the camera.~   "
135634|NCT01279551|"~     This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the~     postoperative pain related to anorectal spasm (anismus) while performing a stapled~     haemorrhoidopexy.~   "
135635|NCT01279538|"~     The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD),~     safety and tolerability of ASKP1240 when administered to subjects who received a de novo~     kidney transplant.~   "
135636|NCT01279525|"~     The purpose of this study is to determine the effectiveness of a multifactorial intervention~     program to prevent falls among the elderly as compared to a brief intervention.~   "
135637|NCT01279512|"~     This study is a prospective randomized clinical trial to compare the endocrine and metabolic~     effects of two anti diabetic drugs (metformin vs. acarbose) in infertile overweight women~     with PCOS~   "
135638|NCT01279499|"~     The objective of this prospective randomized clinical study was to compare anesthesia, in~     morbidly obese patents (BMI >50) who underwent BPD-RYGBP with either sevoflurane or propofol~     with remifentanyl.~   "
135639|NCT01279486|"~     Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to~     the UK trial centre.~      Volunteers will be required to use the Clearblue Pregnancy Test according to the product~     instructions, and provide a urine sample from the same void.~      Trained technicians will conduct a second test from the urine sample.~   "
135640|NCT01279473|"~     This study will investigate if nilotinib provides an improved safety and efficacy profile~     over that seen in patients receiving Imatinib.~   "
135641|NCT01279460|"~     This study aimed to investigate in a cohort with chronic kidney disease the longitudinal~     relationship between aortic stiffness and renal function and mortality.~   "
135642|NCT01279447|"~     The purpose of this study is to determine whether infrapatellar branch of the saphenous~     nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and~     improving long term outcome scores after knee arthroscopy.~   "
135643|NCT01279434|"~     Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from~     simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a~     more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as~     infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve~     NASH when used alone, a combination of these two should be expected to give better results~     because of targeting two different pathogenetic mechanisms (cytokines amplification and~     oxidative stress) in NASH patients. This will be open labelled, prospective, randomized~     study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings~     suggestive of fatty liver and presence of insulin resistance or features of metabolic~     syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all~     cases.~   "
135644|NCT01279421|"~     This project will first increase the accessibility and acceptability of rapid HIV testing in~     health clinics located in or near four low-income communities in San Salvador, El Salvador.~     The investigators will use crack users' social networks and small incentives, as recommended~     by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social~     Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the~     intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network~     Intervention among 400 crack users to change norms supporting HIV protective behaviors. The~     intervention will include monthly meetings open to crack using and non-crack using community~     residents to reinforce HIV risk reduction skills, and discussion of other topics related to~     HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness~     events. Our hypothesis is that these two intervention features will singly, and in~     combination, reduce HIV risk behaviors among Salvadoran crack users.~   "
135645|NCT01279408|"~     The aim of the study is to assess current practice within PROP & lung teams, for treating~     asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to~     observe outcomes for those patients receiving immediate or deferred RT. This is a~     prospective cohort trial. Patients will be managed by immediate radiotherapy (RT) or a~     deferred approach according to physicians' individual current clinical practice. Baseline~     and follow-up data collection will be structured to focus on patient-reported measures to~     describe clinical outcomes in the two management groups. Indications for prescribing RT and~     dose fractionation schedules will also be collected. A new intervention will not be~     introduced during this trial. Instead, a follow-up regimen will be offered to both groups of~     patients, so that RT can be offered to the deferred group of patients if/when symptoms~     develop, and we can monitor symptoms/toxicities and QoL in both groups of patients.~   "
135646|NCT01279395|"~     We hypothesize that administration of anti-inflammatory medications such as celecoxib,~     naprosyn and diclofenac will cause changes in the blood plasma and white blood cells of~     patients such that they will be less able to efficiently process cholesterol.~   "
135647|NCT01279382|"~     In this trial, the effects of two psychological interventions - i.e. hypnotherapy and~     relaxation training - are compared with care as usual in IBS treatment. The investigators~     hypothesized that hypnotherapy is most effective in reducing complaints in IBS.~   "
135648|NCT01279369|"~     The purpose of this study is to determine if the presence of fetal fibronectin in the~     cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending~     preterm delivery due to abruptio placenta.~   "
135656|NCT01279265|"~     This study will compare 2 currently marketed formulas in healthy full term babies:~     Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with~     Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to~     compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of~     intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number~     of white blood cells in the large intestine (fecal calprotectin). The investigators predict~     that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an~     important component of the neonatal intestinal microbial community and reduce fecal~     calprotectin.~   "
135657|NCT01279252|"~     The purpose of this study is to evaluate whether patients with previously untreated, early~     stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis~     that occult bacterial infections are involved in the induction and maintenance of CLL.~   "
135658|NCT01279239|"~     The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe~     multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics~     methodology and advanced mathematics tools.~   "
135659|NCT01279226|"~     The purpose of this pilot research study is to collect information on the safety and~     effectiveness of an experimental device intended to be used to improve the appearance of the~     skin by reducing the visibility of wrinkles and by reducing the looseness of skin.~   "
135660|NCT01279213|"~     augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has~     not been tested until now in randomized controlled trials. This combination is supposed to~     have therapeutic efficacy in the treatment of resistant schizophrenia.~   "
135661|NCT01279200|"~     The purpose of this study is to investigate monitoring methods during ovulation induction~     cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction~     cycles with letrozole can be done with a variety of methods, the two most commonly utilized~     are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle~     follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add~     extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).~   "
135662|NCT01279187|"~     Good bone healing and bone build-up are necessary for the success of dental implants.~     Research in animals and humans has shown that a drug, called Forteo, can increase bone~     build-up and bone strength over time. Forteo has been approved by the Food and Drug~     Administration (FDA) for use in patients with a condition where bone is broken down and~     weakened, called osteoporosis. The investigators do not know, however, whether Forteo is~     effective for use in humans for improving bone healing after implant placement, and whether~     it will have the same bone-building and bone-strengthening effects as for patients with~     osteoporosis. This research study is being done to learn what effect 7 weeks of treatment~     with Forteo will have on bone build-up and strengthening of bone for patients receiving~     implants.~   "
135663|NCT01279174|"~     Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as~     knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is~     generally higher than that of coxarthrosis.~      Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through~     either mobility or medication. Non-pharmacologic treatment is the first step, followed by~     the addition of analgesic medication, and ultimately by surgery.~      The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function,~     which in turn both prevents formation of and delays progression of OA. A modification of~     conventional physiotherapy, whole body vibration has been successfully employed for several~     years. Since its introduction, this therapy is in wide use at our facility not only for~     gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.~   "
135664|NCT01279161|"~     The project aims at assessment of the effect of the FTO gene polymorphism and the type of~     treatment on the development of overweight/obesity and features of metabolic syndrome in~     children with type 1 diabetes.~      Gene polymorphism including some genetic variants may predispose to the development of~     cardiovascular diseases and their complications. The A allele of the FTO gene predisposing~     to obesity occurs in approximately 40% of the European population and each copy of this~     allele can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic~     patients may result in excess body weight gain. Therefore we need studies involving large~     groups of children and assessing cardiovascular risk factors in type 1 diabetes along with~     their genetic associations.~      Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years.~     Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The~     following variables will be assessed in the treatment group: 1) Anthropometric data and~     questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip~     circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1~     or 2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the~     disease onset, treatment regimen, mean daily insulin consumption per kg body weight, brands~     of insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes~     onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory~     data - lipid profile and blood pressure (average of three measurements). Methodology: Gene~     polymorphism analysis in the extracted DNA will be made with the real-time PCR method using~     TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and~     clinical variables such as BMI (including BMI increase since the disease onset), body weight~     and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure~     will be assessed by a professional statistician with a specially dedicated software.~     Moreover parameters such as diet and metabolic control will be assessed. As regards insulin~     therapy the following variables will be analysed: insulin injection device, therapy regimen~     (intensive versus functional; brands and types of insulin products: human insulin versus~     insulin analogue), consumption of insulin. All of the above listed variables will be~     correlated with the genotypes found in the gene polymorphism analysis. The study has been~     approved by Bioethics Committee of the Medical University in Białystok.~      Results: The authors of the project expect that the effect of the FTO gene polymorphism on~     overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will~     be shown. Moreover the project will enable assessment of the effect of the therapeutic~     regimen, including the type of insulin product, on body weight increase in the course of~     type 1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the~     above associations and identification of a group at risk of excess body weight increase in~     the course of insulin therapy may help physicians, parents and patients to avoid this~     complication. Therefore clinical benefit of this project will include identification - based~     on the genetic assays results - of a group of type 1 diabetic children particularly likely~     to develop overweight, obesity and other cardiovascular risk factors.~   "
135665|NCT01279148|"~     This prospective, randomized, controlled, parallel-design trial will compare the use of~     electromagnetic tracking and image guidance during biopsy/ablation procedures verses the~     typical standard or conventional image guided procedure alone (control). US~     ultrasound-guided biopsies/ablations with or without CT computed tomography- imaging will~     be used to complete the procedures in either the CT suite or a procedure room, at the~     discretion of the physician, and according to normal local practice patterns.~   "
135666|NCT01279135|"~     The study tests Tomtherapy based Image Guided Radiation against conventional radiation~     techniques for it's ability to reduce long term small bowel toxicity.~   "
135667|NCT01279122|"~     The purpose of this study is to look at how well you see the Nanoflex Intraocular lens~     placed in your eye.~   "
135668|NCT01279109|"~     The purpose of this study is to examine whether we can use social networks to spread health~     information and health behaviors during pregnancy to prevent excessive gestational weight~     gain.~   "
135669|NCT01279096|"~     The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited~     Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with~     etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and~     safety of this combination regimen to treat children with high risk relapsed or refractory~     acute lymphoblastic leukemia (ALL).~   "
135670|NCT01279083|"~     To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in~     subjects with primary open-angle glaucoma or ocular hypertension.~   "
135671|NCT01279070|"~     The purpose of this study was to develop an integrative intervention for schizophrenia~     taking into account previous efficacious therapies. Thus, our aim was to evaluate the~     efficacy of our cognitive remediation group training: Problem Solving and Cognitive~     Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in~     schizophrenia patients. We hypothesized that training executive function and metacognition~     would allow us to achieve improvements in neurocognition, functioning and psychiatric~     symptoms of patients with schizophrenia.~   "
135672|NCT01279057|"~     This study will compare the safety and efficacy of a generic fluticasone furoate nasal spray~     to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally~     both the test and the reference formulations will be tested for superiority against a~     placebo nasal spray.~   "
135674|NCT01279031|"~     The purpose of this study is to look at the outcomes of your vision after your cataract~     surgery based on two different types of equipment that will be used during your surgery.~   "
135675|NCT01279018|"~     Breast cancer treatment is for many patients followed by sequelae, such as persistent pain,~     sensory disturbances, lymphedema and reduced physical function. These undesired consequences~     of the treatment are a major clinical problem, with persistent pain affecting 25-60%,~     sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of~     patients. Development of persistent pain after breast cancer treatment, involves a complex~     pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors~     for the development of persistent pain after breast cancer treatment have been identified;~     young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is~     a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this~     nationwide study is to retrospectively examine a cohort of breast cancer patients treated~     with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of~     persistent pain and other sequelae.~   "
135676|NCT01279005|"~     Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a~     medical sociologist. Two groups will be HIV negative participants and two groups of HIV~     positive MSM. Every group will meet for two hours. The focus group will be recorded and the~     collected data will be processed further for evaluation and extraction of the relevant~     information.~      The volunteers will sign an inform consent prior to entrance to the study.~   "
135677|NCT01278992|"~     The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue~     when compared to placebo in nurses involved in shift work.~   "
135678|NCT01278979|"~     This study aims to compare different midwife practitioners assessments of perineal tears.~   "
135679|NCT01278966|"~     The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children~     and adolescents with drug-resistant epilepsy regarding seizure control, and to create a~     protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.~   "
135680|NCT01278953|"~     The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing~     catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be~     randomized for treatment with either the TactiCath catheter or another ablation catheter~     with no contact force sensing capability. Patients will be followed for 12 months to compare~     the incidence of serious adverse events and freedom from recurring, symptomatic AF between~     the two study arms. Additional measures of treatment success including quality of life,~     recurrence of asymptomatic AF and procedural efficiency will also be studied.~      A second phase of the study will treat up to 50 non-randomized subjects with a new version~     of the device under the same protocol.~   "
135681|NCT01278940|"~     PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients`~     tumour mRNA transfected DCs .~      SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific~     T-cell response) and assessment of tumour response~   "
135682|NCT01278927|"~     This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The~     purpose of this study is to test whether exercise or stress management training delivered to~     autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to~     transplantation can improve functional status and the transplant experience.~   "
135683|NCT01278914|"~     PRIMARY OBJECTIVES:~      Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood~     samples, and adverse events).~      SECONDARY OBJECTIVES:~      Determine immunological response to the vaccine (induction of specific T-cell response) and~     assessment of tumour response.~   "
135684|NCT01278901|"~     STUDY PROTOCOL:~      The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons.~     The patients should not be on PPI therapy . If during the gastroscopy there are some~     pathologies that require a second look endoscopy after some weeks of therapy (ulcers or~     esophagitis), the investigators will repeat the gastroscopy within a month.~      During the first gastroscopy a biopsy will be taken for histological examination and for a~     rapid urease test and an urea breath test will be done soon after the procedure.~      If one of the tests is positive the investigators postulate that the Helicobacter pylori is~     actually present.~      After the gastroscopy the patient is given a full dose of PPI (as indicated) and~     helicobacter tests are repeated in the next endoscopy (under PPI therapy) . Any positive~     test that become negative in the second endoscopy is considered false negative.~   "
135685|NCT01278888|"~     Is thoracoscopic surgery better than traditional open surgery for lung cancer?~      Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic~     than traditional open surgery for lung cancer but this has never been documented in a~     randomized trial. Some surgeons hesitate to use VATS because it is technically more~     demanding, others question if the two methods are oncologically equal. Regardless, VATS has~     been implemented as a routine method for lung cancer surgery several places around the world~     including Odense University Hospital. The investigators have launched the first randomized~     controlled trial in the world comparing the two surgical methods to investigate any~     differences in length of hospitalization, postoperative pain, life quality within the first~     year, and health economical aspects.~      The investigators include patients with stage I and II lung cancer, and randomize between~     VATS and open surgery in a design where both the patient and doctors doing general rounds in~     the ward are blinded until discharge because the dressing on the surgical wound is~     identical, regardless of the surgical method. The surgeon cannot influence clinical~     decisions including time to discharge, which is decided by other specialist surgeons. Pain~     evaluation is performed 6 times daily using the VAS-score, life quality is evaluated~     continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the~     consumption of analgetics in both groups are monitored via the national prescription~     database.~      Parallel to this trial a similar clinical study, which is also the first of its kind in the~     world, has been launched for patients with lung cancers not eligible for VATS. They are~     randomized between the two traditional open surgical methods (anterolateral and~     posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds~     until discharge from hospital, and endpoint are similar in the two studies.~      250 patients will be asked to participate in each study - so far, 91 patients has been~     randomized and patient accrual is beginning soon at Skejby University Hospital,Denmark in~     collaboration with surgeons from department of thoracic surgery.~   "
135686|NCT01278875|"~     High density lipoproteins (HDL) have many effects that protect against cardiovascular~     diseases. In an acute heart attack (acute coronary syndrome -ACS), HDL change in composition~     and structure, reflecting the inflammatory environment that accompanies an ACS. The~     investigators will examine the function of HDL during an ACS and again when the patient has~     recovered.~   "
135687|NCT01278862|"~     Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided~     Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled~     using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand~     fabricated porcelain covering.~   "
135783|NCT01277822|"~     This study will determine whether using losartan and amlodipine together will be~     non-inferior in lowering blood pressure than amlodipine alone.~   "
135688|NCT01278849|"~     This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v.~     administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying~     degrees of hepatic impairment. The study will be carried out in cancer volunteer patients~     (utilizing controls with normal hepatic function) who will be assigned to four hepatic~     impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study~     will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a~     single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired~     hepatic function, and compared to controls with normal hepatic function. The assessments~     will be done on the safety and tolerability of that single dose in adult cancer patients~     with impaired hepatic function and compared to controls with normal hepatic function. The~     Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same~     three doses in combination with a sponsor-approved taxane-based regimen in adult cancer~     patients with impaired hepatic function and compared to controls with normal hepatic~     function.~   "
135689|NCT01278836|"~     The purpose of this study is to determine the effects of fasciocutaneous flaps for leg~     defects.~   "
135690|NCT01278823|"~     The purpose of this study is to determine the effects of bariatric surgery on blood sugar~     control and underlying mechanisms that contribute to type 2 diabetes in men and women with a~     BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y~     gastric bypass operation or intensive medical, dietary and exercise management.~   "
135691|NCT01278810|"~     To assess safety, tolerance and PK profile of different doses(50mg,100mg,200mg,300mg, 400mg,~     500mg,QD)of Icaritin in advanced breast cancer Patients in China~   "
135692|NCT01278797|"~     This study will be an open-label, randomized, two-treatment, two-period, two-sequence~     crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer~     Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination~     tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).~   "
135693|NCT01278784|"~     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the~     elderly population. One mainstay of therapy for patients suffering from DES is the use of~     topically administered lubricants. However, despite many efforts, no ideal formulation has~     yet been found.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with~     favourable biological properties such as high biocompatibility and low toxicity.~     Additionally, the new formulation comprises N-acetylcysteine, which has been used in~     ophthalmology because of its mucolytic properties for several years. Based on theoretical~     considerations, one can hypothesize that the new chitosan derivative may show an increased~     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in~     reducing the symptoms associated with DES. We have recently shown in a phase I trial that~     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young~     healthy subjects. However, due to the fact that intraocular pressure has been measured as~     one of the main safety variables, topical anesthesia was necessary. Thus, the data about~     local ocular discomfort after administration are limited. This trial seeks to investigate~     whether single instillation of chitosan-N-acetylcystein leads to ocular discomfort such as~     burning and stinging.~   "
135694|NCT01278771|"~     This is a retrospective study. The investigators shall review the angiography data of 1200~     consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart~     Disease) since 1998 till now.~      Coronary artery origin and course will be evaluated in relation to the morphologic cardiac~     anomalies.~      Coronary artery anomalies will be described and statistical analysis will be performed.~   "
135695|NCT01278758|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in~     patients with refractory or relapsed metastatic cancer with impaired renal function and with~     normal renal function. It is very possible that patients with renal impairment will show~     differences in renal excretion of parent ASA404 and its metabolites, warranting a study that~     leads to a better pharmacokinetic assesssment in this population.~   "
135696|NCT01278745|"~     All people who have a heart transplant are at risk for developing cardiac allograft~     vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated~     with poor heart transplant function. People who develop antibodies after transplant have a~     higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the~     risk of developing CAV. People who develop CAV usually have to receive another transplant.~   "
135697|NCT01278732|"~     The investigators aim to investigate whether central systolic blood pressure, as measured~     during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of~     left ventricular mass than peripheral systolic blood pressure during ABPM.~   "
135698|NCT01278719|"~     Nasal polyp is a significant health problem with a prevalence of 4%. It is increased in~     patients with asthma (7-15%), Cystic fibrosis (39-56%) or aspirin intolerance (36-96%).The~     quality of life (QOL) is worse than in patients suffering from hypertension, migraine,~     angina pectoris and head & neck cancer as per a previous study by Videler WJM et al.QOL is~     in comparison to chronic obstructive pulmonary disease.The reason why it develops in some~     and not in others remains unknown despite the disease being present for centuries.A definite~     relationship exists in patients with 'Sampter triad': Asthma, non steroidal~     anti-inflammatory drug sensitivity and nasal polyps. But not all patients with NSAID~     sensitivity have nasal polyps and vice verse.~      Etiology is largely unknown despite the disease being present for centuries. Although the~     factors like wood stove exposure, smoking, allergic rhinitis, rhino sinusitis have been~     strongly implicated in literature from various studies, most data available is on ethmoidal~     polyps.The present study is an attempt to study the association of important risk factors~     with both antrochoanal(AC) and ethmoidal nasal polyps(EP).One study found that a~     significantly smaller proportion of the population with polyps were smokers compared to the~     unselected population (15% v/s 35%). But this is not confirmed by other studies.~      Seven percent of asthma patients have nasal polyps and in non atopic asthma and late onset~     asthma, polyps are diagnosed more frequently (10-15%).Eosinophil numbers are significantly~     higher in nasal polyp tissue and further increased in patients with co-morbid asthma and~     aspirin sensitivity.~      Nasal colonization in increased amounts was found by Staphylococcus aureus and presence of~     specific Immunoglobulin E directed against S.aureus enterotoxins was found. Rates of~     colonization and IgE presence in nasal polyp tissue were increased in subjects with nasal~     polyp associated with co-morbid asthma and aspirin sensitivity.~      Nasal polyps are frequently found to run in families, suggesting a hereditary or with shared~     environmental factor. In the study by Rugina et al., more than half of 224 nasal polyp~     patients (52%) had a positive family history while the study by Greisener et.al, reported~     14% of family history strongly suggesting hereditary factors in the pathogenesis of nasal~     polyps.~      Some studies have found environmental factors like smoking and those using wood stove as a~     primary source of heating with the development of nasal polyps. The studies are contrasting.~      There is presently a need of understanding the differences in the pathogenesis of~     antrochoanal polyp and ethmoidal nasal polyp clearly.There are hardly any concrete research~     performed on them to note the differences in the etiology and their pathogenesis. Hence the~     study is undertaken to extensively study the etiologies responsible for them and to note the~     differences.~   "
135699|NCT01278706|"~     Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal~     time of performing the biopsy is yet to be established.~      In this study, the investigators will compare different temporal timing of the biopsies with~     regards to the menstrual cycle and their affect on the success rates of the treatment.~   "
135700|NCT01278693|"~     The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid~     profile, anemia, and quality of life.~   "
135701|NCT01278680|"~     Employees of Blue Shield of California (BSC) will be recruited to participate to regularly~     use Walkstations. Some participants will be randomly assigned to a hold out control~     condition and the remainder will be assigned to one of two experimental treatments: Personal~     Incentive vs. Charitable Incentive. In the Personal Incentive condition people will be paid~     $3 for every completed Walkstation session, whereas for participants in the Charitable~     Incentive condition $3 will be donated to a specific charity. The incentives will operate~     for approximately 45 days and then for an additional 45 days participants in the two~     experimental conditions will have access to the Walkstations. Participants in the hold out~     control condition will begin using the Walkstations after the initial 90 day period.~   "
135702|NCT01278667|"~     Children with ADHD are in high risk to develope social difficulties. The present study will~     examine the emotional processing in those children. The main purpose is to investigate the~     connection between memory and recognition of facial expressions, how those abilities~     influence social functioning and if Methylphenidate influence the emotional processing.~      The study will include 80 children in ages 9-12 years, devided in 2 groups; children with~     ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do~     computerized tasks that examine recognition and memory of facial expressions. Social~     function will be examined by questionnaires filled by parents and teachers.~   "
135703|NCT01278654|"~     The purpose of the study is to learn more about effective ways to motivate people to~     increase their non-exercise energy expenditure exercise. This is an important research~     question because obesity and weight-related issues are increasingly becoming a problem in~     America. This project will address this research question by testing the effect of two~     different incentive schemes in motivating employees who are predominantly sedentary to use~     Walkstations at work. The Walkstations are treadmills that move at a very slow rate (maximum~     2miles / hour) and are attached to a work station (i.e. with computer and telephone); they~     therefore are designed to increase energy spent not through heavy exercise, but through~     small changes in posture and movement associated with routines in daily life (called~     nonexercise activity thermogenesis or NEAT).~      Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects~     will be the control participants from the previous Walkstation study we ran with BCBSMA. All~     120 control participants from this previous study will be told that they can now participate~     in a study that involves the Walkstations (up until now, they have not been given access to~     the Walkstations). These participants from the previous study will be sent an email~     informing them that they are eligible to participate in this new Walkstation pilot. Those~     who are interested in participating will then be invited to sign up for an enrollment~     session. There will be no incentives for participating in the initial enrollment session.~     For the 2 month follow-up session, participants will have a chance to win 1 of 3 prizes (1 *~     $100, 2 * $50) for completing the follow-up.~   "
135704|NCT01278641|"~     A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or~     Chronic Widespread Pain (Wolfe 1990) participate in the study.~      The main objective of the study is to compare the effect of a graded strength training~     program and a low intensive pool exercise program.~   "
135705|NCT01278628|"~     Physical activity is considered important in prevention and treatment of obesity and~     metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated~     with the development of metabolic syndrome. However, scarce evidence exists regarding the~     influence of physical activity intensity and genotype on metabolic syndrome in people with~     obesity. The investigators examine physical activity using an uniaxial accelerometer, as~     well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes~     related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal~     obesity who were employees in silicon wafer manufacture and participated in a health~     checkup.~   "
135706|NCT01278615|"~     This phase II clinical trial is studying how well selumetinib works in treating patients~     with relapsed or refractory diffuse large B-cell lymphoma. Selumetinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
135707|NCT01278602|"~     The aim of study is to prove R-ESHAP regimen followed by autologous stem cell~     transplantation as salvage treatment in patients with refractory or relapsed diffuse large~     B-cell lymphoma is effective.~   "
135708|NCT01278589|"~     The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L.~     extract in subjects with mild hyperlipidemia.~   "
135709|NCT01278576|"~     The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between~     two different injection sites, namely at the proximal portion of the gastrocnemius(GCM)~     versus at the midbelly of the GCM.~   "
135710|NCT01278563|"~     Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management~     of obesity and associated metabolic risks including diabetes. However, evidence from~     long-term, randomized controlled trials exploring the relationship between low GI diet,~     weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern~     food-processing technology has produced many food products with high GI which may contribute~     to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early~     life, adolescence is a critical period to educate our young people to acquire a healthy~     eating habit to prevent obesity.~      The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater~     reduction in body mass index and body fat percentage, enhanced insulin sensitivity and~     favorable changes of cardiometabolic risk factors compared to conventional diet after 12~     months of intervention.~      This study is a randomized controlled trial of a low GI (<55) versus conventional Chinese~     diet (GI>/=70) in adolescents (12-month intervention followed by a 6-month observational~     period) to study; 1) the changes in body mass index and obesity associated changes in~     cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.~   "
135711|NCT01278550|"~     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and~     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence~     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events~     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of~     bleeding is low, aspirin users who do not have previous ulcer disease do not require~     prophylaxis with anti-ulcer drugs. In contrast, aspirin users with a history of ulcer~     disease have a 2- to 4-fold increased risk of ulcer bleeding. The best strategy for reducing~     the risk of bleeding in high-risk aspirin users remains unclear. Current strategies for~     high-risk patients include the use of anti-ulcer drugs, elimination of risk factors (e.g.~     Helicobacter pylori). Recently the investigators have shown that among aspirin users who are~     infected with H. pylori, the eradication of H. pylori is comparable to omeprazole, a proton~     pump inhibitor (PPI), in preventing recurrent ulcer bleeding in 6 months.~      The investigators postulated that among patients with H. pylori infection and a history of~     ulcer bleeding who continue to use low-dose aspirin, the long-term risk of ulcer~     complications after eradication of H. pylori is comparable to that of average-risk aspirin~     users.~   "
135712|NCT01278537|"~     The aims of this study are to investigate whether patient empowerment, including information~     and decision-aids adapted to the risk and the need of the elderly patient, can improve~     outcome in an evidence-based modular pathway in terms of~        -  shortened hospital stay by a reduced postoperative complication rate and~        -  quality of life in elderly patients compared to control patients receiving standard of~          care.~   "
135713|NCT01278524|"~     An anonymous international multicenter - clinical survey, one-day observational study.~   "
135714|NCT01278511|"~     This study is designed to evaluate the safety, level of performance and level of comfort~     with the Canadian C-Spine rule in a prehospital setting by emergency medicine~     undergraduates.~   "
135715|NCT01278498|"~     Through this study, the investigators are to demonstrate the superiority of Escitalopram~     over placebo for the prevention of poststroke depression in patients with acute stroke~      The primary hypothesis of this study is;~      This study will prove the superiority of Escitalopram on the prevention of poststroke~     depression in patients with acute stroke against placebo~   "
135716|NCT01278485|"~     This is a multicenter, observational, retrospective and cross-sectional study to be~     conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus~     (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF)~     combination therapy by their cardiologist, nephrologist, or family practice doctor for at~     least 6 months prior to study enrollment.~      The purpose of the study is to assess treatment patterns, goal attainment rates, long-term~     diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM~     participants treated in cardiology, nephrology and family practice settings.~   "
135717|NCT01278472|"~     Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone~     disease. Single-port access cholecystectomy (SL) has been recently introduced using only~     one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However,~     it is unknown whether SL significantly improves body and cosmesis images as well as the~     quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce~     postoperative pain and to be cost-effective due a faster postoperative recovery.~      The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL~     is superior to LC in improving patients', body and cosmesis images as well as QoL and to~     analyse cost-efficiency.~      Based on the sample size calculations, a total of 110 patients will be randomised to either~     LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to~     convalescence, quality of life and complications and will also be compared as secondary~     endpoints.~      This study will provide evidence-based patient-oriented information regarding the SL~     procedure and its further use.~   "
135718|NCT01278459|"~     The purpose of the study is to test the hypothesis that a short course of atorvastatin can~     improve vascular function in women with a history of preeclampsia, compared to placebo.~   "
135719|NCT01278446|"~     The primary objective of this clinical trial is to determine whether a new extensively~     hydrolyzed infant formula is hypoallergenic.~   "
135720|NCT01278433|"~     The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in~     China.~      Objective:~      To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at~     2, 3, and 4 months of age among infants living in the study cities of China.~   "
135721|NCT01278420|"~     The purpose of this study is to compare the visual outcomes with bilateral implantation of~     Tecnis MF and ReSTOR IOLs Six months post cataract surgery.~   "
135722|NCT01278407|"~     The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with~     Lewy bodies (DLB).~   "
135723|NCT01278394|"~     The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in~     the treatment of distal, subungual onychomycosis of the great target toenail.~   "
135724|NCT01278381|"~     Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative~     complications. No score is currently available to help identify the patient's surgical risk.~     The purpose of this study was to develop and validate a prognostic score to predict major~     postoperative complications after PD.~   "
135725|NCT01278368|"~     No comparative trial investigating the effect of preoperative chemotherapy for locally~     advanced pancreatic cancer on short-term postoperative outcome has been published so far.~     The aim of the present study is to assess the potential impact of preoperative chemotherapy~     on short-term postoperative outcome after pancreatic resection in a case-matched series of~     cancer patients.~   "
135726|NCT01278355|"~     The purpose of this study is twofold: 1) to test the feasibility of integrating a simple~     bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the~     standard care delivered in the Aeromedical Evacuation system and 2) to observe and document~     any changes in pain scores and in-flight related symptoms and factors (e.g. sinus~     block/pain, ear block pain, nausea/air sickness) typically monitored during transportation~     of wounded warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).~   "
136485|NCT01268488|"~     The purpose of this study is to evaluate the performance of an investigational blood glucose~     meter with the Contour sensor strip. It was decided that this investigational monitoring~     system would not be part of a regulatory submission and it will not proceed to marketed~     product.~   "
135727|NCT01278342|"~     This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose~     monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone~     antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth~     factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at~     conventional regimen.~   "
135728|NCT01278329|"~     Auditory stimulation during pregnancy has been found to influence foetal behaviour with a~     potential of being carried forward to neonatal period. This study evaluated the effect of~     ante-natal music exposure to primigravida healthy mothers on the behaviour of their term~     appropriate-for-date newborns. This was a single centre, randomized, open-label controlled~     trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or~     significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were~     randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in~     addition to standard ante-natal care (intervention arm) or standard care only (control arm).~     Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol~     violations. The infants born to mothers exposed to music during pregnancy performed~     significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen~     with respect to orientation and habituation.~      Conclusion:~      Music exposure to mother during pregnancy significantly influences neonatal behaviour.~   "
135729|NCT01278316|"~     This study is being conducted to understand whether training in tasks that require~     perceiving and thinking about things, or cognition, can improve memory in veterans who have~     been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to~     determine whether it is feasible for veterans who don't live close to a VA to perform this~     cognitive training at home.~   "
135730|NCT01278303|"~     Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood~     flow through the aorta. Coarctation can occur in isolation, in association with bicuspid~     aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000~     (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in~     childhood; < 25% recognized beyond 10 yrs.~      CoA is mostly repaired in childhood by surgery or by balloon catheter dilation. Recurrence~     rates range from 5-20%. Recurrence is often not recognized until adolescence. Balloon~     expandable stents have become the predominant therapy in the USA and Europe for CoA~     treatment in this age group. There are no FDA approved stents for this use. Biliary stents~     are currently being used off label. Enrollment into a trial of bare metal Cheatham Platinum~     (CP) Stents, designed for use in CoA, is completed. The Coarctation of the Aorta Stent Trial~     (COAST) aims to confirm safety and efficacy of CP Stent for native and recurrent CoA.~      There are CoA patients with clinical situations that place them at high risk of aortic wall~     injury during bare metal stenting. Extreme narrowing, genetic aortic wall weakness and~     advanced age are examples. Patients may present with aortic wall injury (aneurysm) related~     to prior CoA repair. The occurrence after surgical repair is 3-4% and after balloon dilation~     10-20%. Repair of these aneurysms is surgically challenging. The use of fabric-covered CP~     Stents to prevent or repair aortic wall injury has become the treatment of choice in Europe~     and recently in the US through the FDA Compassionate Use process. There are no alternative~     devices available in the US. COAST II will test safety and efficacy of Covered CP Stents to~     repair or prevent aortic wall injury associated with CoA.~      Funding Source-FDA OOPD~   "
135731|NCT01278290|"~     The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency~     of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.~      Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.~      Study population are girls with suspicious clinical features of precocious puberty~   "
135732|NCT01278277|"~     The general area of research in which this project has been designed is that of retinal~     degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus~     flavimaculatus retinal dystrophy (STD/FF). STG/FF is one of the major causes of vision~     impairment in the young age. STG/FF originates typically from the dysfunction and loss of~     cone and rod photoreceptors, developing through a photo-oxidative mechanism. The major~     disease locus is the central retina, i.e. the macula, whose neurons have the highest density~     and underlie critical functions such as visual acuity, color vision and contrast~     sensitivity. There is currently no cure for STG/FF. Recent experimental findings indicate~     that Saffron, derived from the pistils of Crocus Sativus, may have a role as a retinal~     neuro-protectant against oxidative damage. The stigmata of Crocus sativus contain~     biologically high concentrations of chemical compounds including crocin, crocetin, whose~     multiple C=C bonds provide the antioxidant potential. In addition it is well known that this~     compound is safe and free of adverse side effects. The aim of this research is to~     investigate the influence of short-term Saffron supplementation on retinal function in~     STG/FF patients carrying ABCR mutations. The macular cone-mediated electroretinogram (ERG)~     in response to high-frequency flicker (focal flicker ERG) will be employed as the main~     outcome variable. Secondary outcome variable will be the psychophysical cone system recovery~     after bleaching.~   "
135733|NCT01278264|"~     Comparing morphine consumption and recovery with two different TAP block techniques after~     abdominoplasty.~   "
135734|NCT01277276|"~     Currently there is no methodology that can assign a risk of development of chemo brain and~     thus, studies to understand how and why only some patients develop chemo brain along with~     studies of potential treatments face major hurdles. This study will define~     hemodynamic/optical parameters in normal individuals and cancer patients undergoing~     chemotherapy potentially identifying optical parameters that are associated with the~     development of chemo brain, leading to new insights into the origin of the chemo brain~     condition, and importantly potentially identifying parameters that may predict who will~     develop chemo brain in order to directing investigations of therapies.~   "
135735|NCT01277263|"~     Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment~     with little or no change in tumor size or overall outcome.~      The Researchers have demonstrated a previously undescribed metabolic flare response~     observed very early in neoadjuvant treatment in breast cancer patients. The research can~     determine that this flare is predictive of overall therapy response and is due to both an~     inflammatory reaction and cell death induced by cytotoxic therapy.~   "
137005|NCT01261728|"~     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin~     for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing~     surgery for kidney cancer.~   "
135736|NCT01277250|"~     This project, Web-based Smoking Cessation Intervention: transition from inpatient to~     outpatient, addresses smoking among hospitalized patients, whose rates are higher than~     among the general population. Hospitalization offers a unique opportunity to intervene, as~     it requires temporary abstinence and patients are focused on health concerns. Hypotheses: A~     tailored web-based and e-message smoking cessation program for current smokers that, upon~     hospital discharge, transitions the patient to continue a quit attempt when home will be~     effective. Further, the investigators hypothesize that this approach will be cost-effective.~     Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention.~     2. To determine the cost-effectiveness of this approach. Research Design - Methods: A~     randomized two-arm follow-up design will be used to test the effectiveness of an evidence-~     and theoretically-based smoking cessation program designed for post-hospitalization.~     Patients randomized to this arm will be contacted by hospital staff, trained as 'transition~     coaches,' to engage in Decide2Quit, an interactive web-based program that offers~     personalized and tailored messages, e-group support, and text messages promoting tobacco~     abstinence. All hospitalized patients will receive standardized smoking cessation materials.~     As well, physicians can order nicotine replacement therapy via the hospital's electronic~     order system. The investigators primary outcome is biologically confirmed and self-reported~     tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported~     quit rates at 3 and 12 months and variables hypothesized to predict quit success. We will~     measure health care utilization and quality of life to allow testing the cost-effectiveness~     of this program conducted from the perspective of a hospital, health care payers, patients~     and society. Significance of results: At study completion the investigators will know~     whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff~     burden, and an interactive web-based tailored intervention program is an effective way to~     reduce smoking rates among hospitalized patients, and if it is cost-effective. This program~     will be an off the shelf approach that could be disseminated easily.~   "
135737|NCT01277237|"~     There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces~     the amount of fat stored in the liver and improves liver function. The purpose of this study~     is to see whether this observation is correct.~   "
135738|NCT01277224|"~     The purpose of this study is to evaluate the effectiveness of a recreational physical~     activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other~     cardiovascular risk factors~   "
135739|NCT01277211|"~     This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of~     pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be~     assessed and compared with that of Yasmin.~   "
135740|NCT01277198|"~     Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic~     pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's~     experience.~   "
135741|NCT01277185|"~     The purpose of this study is to identify calcium metabolism characteristics in Mexican~     American adolescents. The investigators predict that calcium requirements to maximize bone~     health in this population will be lower than for white youth but higher than their current~     intakes.~   "
135742|NCT01277172|"~     This is a prospective international, multi-center, randomized, double-blind controlled study~     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of~     PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously~     untreated patients with diffuse B cells Non Hodgkin lymphoma.~   "
135743|NCT01277159|"~     Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve~     block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa~     nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg~     2008;106:1916-20), but unfortunately the patients still often experience moderate to severe~     pain after the block wears off. The investigators wish to study two additives that may~     prolong the period of analgesia provided by the nerve block. The additives will be studied~     in the context of a standardized postoperative multimodal analgesic pathway.~      Primary outcome:~      Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a~     popliteal fossa nerve block?~      Secondary outcomes:~      Does adding dexamethasone and/or buprenorphine to a popliteal fossa nerve block improve:~     Pain scores? Quality of recovery? Satisfaction?~      Does adding dexamethasone and/or buprenorphine to a popliteal fossa nerve reduce:Opioid~     consumption? Opioid-related symptoms? Sleep disturbance?~   "
135744|NCT01277146|"~     This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously~     treated solid tumors for which there is no remaining standard curative therapy and no~     therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2~     centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers,~     and efficacy. No formal interim analyses will be performed.~      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon~     enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned~     dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If~     there is no evidence of disease progression or if the tumor is smaller, then subjects may~     continue to receive IV infusions of OMP-59R5 every week until disease progression.~      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose~     escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled~     in a cohort will not be treated on the same day. The dose may be administered at any time~     during the day. Three subjects will be treated at each dose level if no dose-limiting~     toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on~     OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be~     expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be~     dosed at that level and 3 additional subjects will be added to the preceding dose cohort~     unless 6 subjects have already been treated at that dose level. Subjects will be assessed~     for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled~     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day~     28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to~     continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14~     subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects~     experiencing a DLT.~   "
135745|NCT01277133|"~     This single arm, prospective, observational study will assess the correlation between the~     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with~     progression-free survival in patients with previously untreated metastatic breast cancer.~     Patients will be followed for up to 12 months after progressive disease occurs.~   "
135746|NCT01277120|"~     This single arm, prospective, observational study will assess the correlation between the~     time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with~     progression-free survival in patients with previously untreated metastatic colorectal~     cancer. Patients will be followed for up to 12 months after progressive disease occurs.~   "
135747|NCT01277107|"~     This is a multi center, double blind placebo controlled, two-way crossover study in patients~     with Insomnia suffering from difficulty in falling asleep and staying asleep. This study~     intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to~     placebo.~   "
135748|NCT01277094|"~     This multi-center, double-blind, randomized, placebo-controlled study will evaluate the~     change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with~     non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral~     doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.~   "
135749|NCT01277081|"~     The aim of this study is to subjectively assess symptoms in subjects suffering from the~     common cold following a single dose of paracetamol hot drink compared to paracetamol tablet~   "
135750|NCT01278251|"~     This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps~     successfully restores elbow function.~   "
135751|NCT01278238|"~     The purpose of this study is to determine wether intravenous Phenylephrine, administered as~     start bolus and following continuous infusion (specific dosage per weight), or optimal lower~     limb bandaging is more effective in preventing hypotension during caesarean section under~     spinal anaesthesia in healthy women.~      The hypothesis is that the Phenylephrine model is superior to lower limb compression in~     preventing hypotension.~   "
135752|NCT01278225|"~     The goal of this study is to learn if using a non-invasive therapy called neurofeedback~     training can help teach patients ways to modify their own brain waves to decrease the~     perception of pain and improve quality of life.~   "
135753|NCT01278212|"~     The goal of this study is to explore the safety, effectiveness, quality of life, and cost~     effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after~     lumpectomy in patients with early stage breast cancer.~   "
135754|NCT01278199|"~     Severe hemoptysis is a life-threatening condition, with an unpredictable course. The~     efficacy of bronchial artery embolization (BAE) is well established for the treatment of~     severe hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50~     to 90% of cases, respectively. As complications related to vascular interventional radiology~     may occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute~     hemoptysis of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of~     severity (respiratory failure or hemodynamic instability). There is no available data~     comparing the safety and efficacy of BAE combined with medical measures to those of medical~     measures alone in the treatment of non-severe acute hemoptysis of mild-to-moderate~     abundance.~   "
135755|NCT01278186|"~     This study in bifurcated coronary lesions compares the new technology of the~     paclitaxel-eluting balloon with the usual technique until now of provisional stenting with~     the paclitaxel-eluting stent in the main branch.~   "
135756|NCT01278173|"~     The purpose of the study is to evaluate the change in visual fields by means of automated~     static perimetry and to evaluate the change in retinal structure by means of spectral domain~     optical coherence tomography (SD-OCT) in adult patients with refractory complex partial~     seizures (CPS) being treated with vigabatrin (Sabril®)~   "
135757|NCT01278160|"~     This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic~     control of biphasic insulin aspart 30 twice daily with two different dosage split regimens~     for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a~     glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).~   "
135758|NCT01278147|"~     The purpose of the present project is to develop, implement and evaluate a pilot regional~     patient education program on the management of one of the main side effects of chemotherapy~     in cancer patients, that is fatigue.~      A carer (doctor or nurse) trained in educational techniques will be responsible for the~     patient. The carer will first identify modes of behavior and competences that the patient~     must acquire in order to optimize his/her management of fatigue (educational diagnosis).~     An education program, based on a contract of goals will be proposed after this diagnosis~     phase. The expected results are, in the short-term, a significant reduction in the mean~     level of fatigue in patients receiving chemotherapy who benefited from individual~     educational management. In the longer term, the aim is to evaluate the impact of this~     program on patient quality of life and use of healthcare structures in comparison with~     conventional management.~   "
135759|NCT01278134|"~     This multicenter, randomized, double-blind, parallel group study will evaluate the safety~     and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without~     Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B,~     interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and~     100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or~     1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm~     patients will be re-randomized to continue assigned treatment for additional 12 weeks or~     stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week~     follow-up.~      As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in~     conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg~     subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a~     24-week follow-up.~   "
135760|NCT01278121|"~     One of today's major health problem in the western world is related to lifestyle. Lifestyle~     diseases include obesity, type 2 diabetes, cardiovascular diseases and different types of~     cancers. For many years, a low-fat diet has been recommended to reduce obesity and lifestyle~     diseases, but replacing fat with carbohydrates has lead to an increase of these diseases.~     Overweight is associated with a chronical low-degree inflammation, and later studies have~     shown that carbohydrates have an effect on the mechanisms of inflammation. Previous studies~     in the investigators group has shown that in healthy, but slightly overweight persons, a~     balanced diet of lower carbohydrate content regulates the gene expression in a manner that~     leads to less inflammation. In this study the investigators will look at morbid obese women~     (BMI>35) to see if the same, balanced diet can improve the inflammatory profile of the~     women.~   "
135761|NCT01278108|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending~     (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
135762|NCT01278095|"~     The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation~     of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of~     GLPG0555.~   "
135763|NCT01278082|"~     This study aims to demonstrate the superiority of budesonide compared to placebo as~     maintenance therapy in keeping patients in remission over a one-year period~   "
135796|NCT01277653|"~     There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the~     role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance~     program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to~     compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in~     diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used~   "
135797|NCT01277640|"~     The purpose of this study is to determine the safety of male genitalia when exposed to~     dapivirine gel following seven once daily applications.~   "
135764|NCT01278069|"~     Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However,~     there are currently no data about the prevalence, sites of occurence and thr prognostic~     value for patients with AML with this finding. Information about this condition is based on~     retrospective analyses since there have been no studies trying to define the role of myeloid~     sarcoma in AML so far. This observational trial will include adult patients with newly~     diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction~     chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction~     chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary~     endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML~     manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.~   "
135765|NCT01278056|"~     This is a Phase I/II open-label uncontrolled, prospective study to assess the clinical and~     biological effects of Deferasirox (ICL 670, Exjade®) in patients with NASH and increased~     iron storage / distribution of iron on liver function and liver histology.~      NASH is defined clinically and histologically by elevated liver enzymes, signs of hepatic~     steatosis on ultrasound and magnetic resonance imaging, impaired liver function as expressed~     by functional breath tests, and significantly altered liver histology.~      Patients will be treated in a phase I and phase II part for either 12 or 48 weeks.~      Both study parts have different endpoints: in phase I the side effect profile will be~     evaluated while in phase II the therapeutic response will be tested. Accordingly, measures~     will be different.~      Approximately 10 patients in phase I and 50 patients in phase II will be enrolled according~     to sample size calculations.~      The design is an adaptive Two-stage design, allowing to minimize the number of patients~     included into the trial as well as to introduce corrections for the second stage.~   "
135766|NCT01278043|"~     Subjects in this study have recently had or are scheduled for a percutaneous coronary~     intervention (PCI) as part of their normal, routine medical care. This procedure should~     restore the blood flow in the vessels of the heart.~      One complication that can occur after a PCI procedure is blood clotting and narrowing of the~     artery in the area that was treated. This can result in a decrease in the blood flow to the~     heart. To avoid this complication, patients are given antiplatelet or blood-thinning drugs~     such as aspirin and clopidogrel as part of their routine care after this procedure.~      For this research study, the investigators would like to take blood samples from subjects at~     3 different time points while they are taking these antiplatelet drugs. The investigators~     will study the subjects' blood and medical history to help us further our understanding of~     how these drugs respond in individuals and in certain patient populations. Everyone responds~     a little differently to medications due to many reasons including our genetic make-up. Genes~     are passed down from our parents and determine our physical appearance such as the color of~     our hair and eyes. Differences in our genes may also help explain why some drugs work in~     some people, but not in others. By studying subjects' blood, medical history, genetic~     make-up and by recording how the subjects' blood responds over the course of their~     treatment, the investigators hope to learn more about how our bodies respond when taking~     these drugs. Additionally, the investigators hope to find better ways to predict who will~     respond more effectively to these drugs and better ways to monitor how these drugs are~     working in patients' bodies over time after PCI procedures.~   "
135767|NCT01278030|"~     The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT)~     responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead~     placement compared to traditional LV lead placement.~   "
135768|NCT01278017|"~     The purpose of the investigators study is to evaluate if short-course of ceftriaxone therapy~     could shorten the clinical courses of severe nontyphoidal Salmonella enterocolitis in~     children and the excretion of Salmonella in feces.~   "
135769|NCT01278004|"~     This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side~     effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive~     substance) to test whether any response is a true effect of the drug, and not a 'placebo~     effect'.~   "
135770|NCT01277991|"~     In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate~     occasions using one of two different strength tablets each time. The amount of CP-690,550~     available in the blood following administration of each tablet will be measured and~     compared. The overall aim of the study is to establish that a similar amount of CP-690,550~     is absorbed into the blood following administration of the same dose of each different~     strength tablet .~   "
135771|NCT01277978|"~     The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on~     maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup~     (TaskeForce®-Monitor) during primary Caesarean section.~   "
135772|NCT01277965|"~     Primary aim:~      To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin~     infusion, adjustment of the recommended basal insulin flow rate in the event of physical~     activity allows the subjects to practice sports without any increase in incidence of~     hypoglycaemia during physical activity or the ensuing hours.~      (NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance~     with the EMEA definition).~      The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80~     percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical~     activity (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be~     studied as an option to adjust insulin dosage in the event of unprogrammed physical activity~     (temporary reduction of basal flow by 100 percent).~      Secondary aims:~        -  Characterisation of hypoglycaemia during and after physical activity based on CGMS~          data: symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of~          hypoglycaemia in relation to the start of physical activity, degree and severity of~          hypoglycaemia.~        -  Evaluation of overall variations in blood glucose in the event of physical activity~          using CGMS data (area under the curve).~        -  Evaluation of glucose restoration methods used in the event of hypoglycaemia.~        -  Analysis of subgroups of patients with and without hypoglycaemia.~   "
135773|NCT01277952|"~     The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe~     disability due to Traumatic Brain Injury.~   "
135798|NCT01277627|"~     Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in~     HIV/HCV-coinfected individuals.~   "
135774|NCT01277939|"~     This study will evaluate the comparative effectiveness of Therapeutic Education System~     (TES), a computer-based, psychosocial treatment program, relative to standard care when~     offered to individuals with substance use disorders in prison settings. The study will~     assess the comparative effectiveness of these interventions primarily by examining changes~     in: (1) substance use (e.g., weeks of abstinence), (2) HIV risk behavior (evaluated as both~     sex-related and drug-related HIV risk behavior) and (3) reincarceration rates. The study~     will also examine the extent to which these interventions improve psychosocial functioning~     (e.g., employment, health, and psychological status) and quality of life, and promote~     relevant skills acquisition (e.g., improve communication skills, reduce criminal~     thinking). The investigators predict significantly better outcomes for E vs. C due to TES'~     research-based content and use of proven informational technologies.~   "
135775|NCT01277926|"~     The purpose of this study is to characterize the current patterns of care for patients with~     hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine~     therapy in Brazil. To investigate patient-related, disease-related and physician-related~     characteristics that correlate with the use of either endocrine treatment or chemotherapy in~     such patients. And to evaluate patients' understanding of the treatment options and their~     participation in the choice.~   "
135776|NCT01277913|"~     The aim of the study is to assess the effect of 12 month supplementation with two different~     doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels~     and hand grip strength in preadolescents with diabetes mellitus type 1.~      100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3~     months, without history of diabetic ketoacidosis during previous month, without other~     chronic disease which may affect calcium-phosphorus metabolism will be randomized in a~     double blind controlled trial to supplement them with either 500 IU or 1000 IU vitamin D.~     Every 3 months, in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin~     D level and HbA1c will be measured. At the entry and at the end of the study patients will~     have total body and lumbar spine bone mineral density assessment. Every six months hand grip~     strength will be measured. Additionally at the beginning and after 12 mo of supplementation~     and at the beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.~   "
135777|NCT01277900|"~     Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric~     surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass~     index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and~     safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the~     most effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The~     investigators intend to run a 3 year prospective multicenter study to evaluate the remission~     efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI~     (BMI:25-35) in Asia area.~   "
135778|NCT01277887|"~     This is a pilot research study examining two types of behavioral counseling along with the~     nicotine patch for smoking cessation. The study is designed to find out whether one of these~     counseling interventions is more effective for smoking cessation among individuals with~     sleep problems. The study has three parts: 1) an intake session; 2) a 10-week treatment~     phase, and 3) a 1-month follow-up.~   "
135779|NCT01277874|"~     This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP)~     respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or~     non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if~     Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP~     without oscillations. This will be measured by need for change to ventilator support,~     improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during~     the period of NCPAP treatment. Other respiratory outcomes will also be compared, including~     time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged~     PiO2 from start of study to end of respiratory treatment.~   "
135780|NCT01277861|"~     The investigators plan to test the hypothesis that pretreatment with fentanyl prior to~     induction of anesthesia would result in reduce the incidence of movements and airway~     responses to desflurane in patients breathing spontaneously through a laryngeal mask airway~     (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the~     incidence of movement during induction of anesthesia. Secondary aim of the study is to~     evaluate the effects of titration of fentanyl according to the respiratory rate on the~     incidence of intraoperative respiratory events such as coughing, breath holding and~     laryngospasm.~   "
135781|NCT01277848|"~     The PLAC1 gene is a recently described X-linked gene that maps to a region of the X~     chromosome thought to be important for normal fetal and placental development. Elevated~     levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to~     disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened~     pregnancy.~      The objective of this study is to measure the prevalence of circulating anti-PLAC1~     antibodies in pregnant maternal serum and correlate it with pregnancy outcome. It is likely~     that women with these antibodies are at higher risk for adverse pregnancy outcomes.~     Approximately 5% (50 of 1000) will be expected to have anti-PLAC1 antibodies based on~     previously reported data. The prevalence of these antibodies and their clinical impact on~     pregnancy outcomes will be determined.~      1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies~     at their routine prenatal clinic visits. Subjects will be enrolled at their first clinic~     visit at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be~     obtained as part of the routine blood draw at the time of enrollment. Blood will only be~     collected when drawn as part of routine laboratory testing as determined by the primary care~     provider.~      Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time~     blood is obtained for routine or otherwise clinically indicated laboratory testing. A~     maximum of 5 samples will be collected through the pregnancy.~      Maternal demographic data will be collected and patients will be followed longitudinally to~     the completion of pregnancy to ascertain their clinical status during pregnancy, onset of~     premature labor, premature rupture of membranes, delivery date, and gestational age at~     delivery.~   "
135782|NCT01277835|"~     The purpose of this study is to determine whether intravenous lidocaine infusion during a~     video-assisted chest surgery is effective in reducing the pain involved after the surgery.~     The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic~     surgery (VATS) reduces morphine consumption and postoperative pain.~   "
135784|NCT01277809|"~     The purpose of this study is to assess the effectiveness of a regular walking program (which~     inevitably involves human interaction) compared to a usual care condition and to a human~     interaction condition (without the extra walking program) in individuals residing in~     Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance,~     walking distance; rate and severity of falls; activities of daily living; mood and~     behaviour.~      It is hypothesized that participants taking part in the walking program will demonstrate~     maximal benefits compared to the no treatment control group (usual care) and the~     participants who will only receive social interaction. It is expected that benefits of the~     walking program will include decreased fall rates, and improved balance, endurance,~     strength, mood, behaviour, activities of daily living and quality of life indices. Given~     research findings that the addition of pleasant activities improves resident mood (Teri et~     al, 1997; 2003), it is expected that participants in the social interaction only group will~     demonstrate improvements in mood and other indices of quality of life.~   "
135785|NCT01277796|"~     Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are~     expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable.~     Thermotherapy is a clinically validated first line alternative for the treatment of~     Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are~     either too costly or lack governmental approval required to be made widely available to~     endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for~     Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot~     study the investigators will enroll 25 patients who have either failed or are not candidates~     for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates~     efficacy non-statistically inferior to estimates for current South American Pentavalent~     Antimonial cure rates (76%) while demonstrating basic safety and tolerability.~   "
135786|NCT01277783|"~     The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective,~     non-randomized, multi-national clinical investigation.~      The purpose of this clinical investigation is to evaluate the safety and performance of the~     investigational atrial transseptal endocardial LV lead delivery system and the implant~     procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a~     superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in~     the Left Ventricle.~   "
135787|NCT01277770|"~     The purpose of this study is to improve outcome for kidney transplant recipients. There has~     not been commensurate improvement in medium and long-term outcomes. Ongoing clinical~     research is necessary to improve transplant outcomes.~   "
135788|NCT01277757|"~     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with~     breast cancer cancer that has spread to other places in the body and usually cannot be cured~     or controlled with treatment. Akt inhibitor MK2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
135789|NCT01277744|"~     The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can~     help to control abdominal tumors in patients having surgery to remove the tumors. The safety~     of this drug will also be studied.~   "
135790|NCT01277731|"~     Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer~     patients undergoing chemotherapy to counteract emetic side effect and essential drug for the~     chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially~     on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone~     relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether~     hiccup side effect is limited to the dexamethasone only or other corticosteroid group.~      Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be~     considered as antiemetic agent for the patients with receiving chemotherapy. The~     investigators perform this pilot study under hypothesis that replacing dexamethasone with~     methylprednisolone could maintain antiemetic role and prevent hiccup.~   "
135791|NCT01277718|"~     This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover~     study of cobimetinib in healthy participants to evaluate the effect of the proton-pump~     inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy~     participants when administered in the fed or fasted states.~   "
135792|NCT01277705|"~     This study will assess the immunogenicity and reactogenicity of the candidate GSK~     Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis-~     inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in~     Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine~     administered separately, and with Revaxis®~   "
135793|NCT01277692|"~     This study is a three Part, Phase 1, randomized, dose-escalation, fusion,~     placebo-controlled, double-blind study to determine the safety, tolerability and~     Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability,~     PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single~     doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses~     in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects~     (Part 3).~   "
135794|NCT01277679|"~     The aim of this study is to establish a model for the evaluation of drug targets using~     postural measures to induce changes in lung water concentration as assessed by MRI. A~     reduction in the magnitude and rate of water transudation with postural changes in patients~     with congestive heart failure (CHF) could provide a model for the evaluation of various~     classes of molecules for target validation and for dose selection.~   "
135795|NCT01277666|"~     This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and~     safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to~     placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease.~     Efficacy will be assessed by proportion of subjects achieving response, defined as a~     decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical~     response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key~     secondary endpoint. Safety will be assessed by recording of adverse events, clinical~     laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics~     will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes~     in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D~     and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.~   "
135799|NCT01277614|"~     The investigators previously established that there was a high burden of disease among all~     categories of staff at the University of the West Indies, St. Augustine and in many ways,~     this group is typical of the working class of the Caribbean population. Many had poor~     lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS~     components. Since most time is spent at work, the workplace is understandably the most~     logical location to address issues pertaining to health, disease prevention and wellness and~     on-site programs have yielded many health and other benefits to employees and employers~     alike. Onwards of the 1980s, numerous studies have been done on work-site intervention~     programs and these have shown that if a company is able to identify employees at risk for~     developing health problems and then intervene, health risks and the resulting medical~     problems are reduced. Such a program, if tailored to meet the needs of participants, may~     yield similar benefits among the staff of the University of the West Indies.~   "
135800|NCT01277601|"~     The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil~     fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus~     standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults~     with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen~     (HBsAg).~      The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48~     Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of~     treatment, participants in these groups will be monitored for 24 weeks for signs of~     worsening HBV, and those meeting TDF retreatment and flare management criteria will be~     eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.~   "
135801|NCT01277588|"~     During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The~     test is performed with the woman in the supine position and is generally described as a~     difficult and cumbersome procedure.~   "
135802|NCT01277575|"~     The investigators assess if repetitive, transcranial alternating current stimulation (rtACS)~     can improve the speaking quality of the aphasic patient as well as other communication~     skills as naming, repeating and understanding spoken words, reading and writing. Further, it~     will be assessed if memory and attentiveness deficiencies after 10 days of therapy with~     brain stimulation are stabilized and remain stable after a training-free period of 60 days.~   "
135803|NCT01277562|"~     The investigators hypothesis is that secondary causes of bone loss are prevalent in patients~     with breast and prostate cancer, and those patients with secondary causes of bone loss are~     at higher risk for treatment related bone loss. The goals of this pilot study are to~     estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with~     nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.~   "
135804|NCT01277549|"~     The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra~     Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of~     differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy~     G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.~   "
135805|NCT01277536|"~     Until now, no risk assessment model informing about the need of thromboprophylaxis in~     patients admitted for an acute medical event has been validated.~      The goal of this project is to indirectly validate a model developed in Geneva by a non~     -interventional study involving the collection of patient characteristics during the~     hospitalization and a 3-month follow-up. These data will allow for the determination of the~     patient's risk, according to the Geneva model, and its validity, according the actual~     thrombo-embolic events, corrected for the thromboprophylaxis received.~      The project is multicentric in Switzerland (5-10 centers) and should involve about 1000~     patients.~      First amendment (may 2011) : we have obtained the IRB approval for collecting data from~     patients who die during their hospital stay and for whom informed consent is not be possible~     to obtain.~   "
135806|NCT01277523|"~     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation~     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks,~     compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to~     17 years old) with severe persistent asthma.~      The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and~     possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary~     pulmonary function endpoint after 12 weeks of treatment.~      Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints,~     and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy~     on top of usual care in this patient population.~   "
135807|NCT01277510|"~     The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the~     current treatment of secondary hyperparathyroidism in children currently receiving dialysis~     compared to a treatment regimen that does not include cinacalcet.~   "
135808|NCT01277497|"~     Chronic kidney disease (CKD) patients often have high levels of a substance called~     fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related~     to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and~     as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels,~     more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine.~     In addition to effects on FGF-23, increased phosphorus levels can lead to calcification~     (hardening) of the blood vessels in the CKD population.~      Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus~     absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD,~     studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering~     FGF-23 levels in CKD patients may also lower substances in the blood that cause~     calcification of blood vessels in the CKD population.~      This study is being done to determine if using phosphate binders, either sevelamer carbonate~     or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease~     FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood~     vessels and heart disease.~   "
135941|NCT01275560|"~     The objectives of this work are: 1/to estimate the frequency of a positive glucose breath~     test in favour of a small intestinal bacterial overgrowth in a population of patients~     consulting for gaz incontinence by comparison to a population of control subjects; 2/to~     estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case~     of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve~     gaz incontinence~   "
135809|NCT01277484|"~     Brief Scientific Rationale:~      Decitabine has been shown to be effective for treatment of MDS and associated with very~     limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects~     of decitabine require an extended period of therapy and are likely to be more beneficial in~     the setting of a minimal residual disease after transplantation. The drug might exert a~     cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and~     HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There~     are lots of evidence which showed the the drug have immunostimulatory effects and can be~     used to enhance graft-versus leukemia effects. And also, some investigator suggested that~     decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs~     which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such,~     decitabine is an ideal agent to be investigated in the post-transplant setting.~      The investigators hypothesized that post-transplant maintenance therapy with decitabine may~     reduce relapse rate, which may maximize the beneficial effects from reduced TRM of~     ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS~     patients.~   "
135810|NCT01277471|"~     Aims and priorities of the project The purpose of this study is to~        1. test the effect of frequency of meals (six vs. two meals daily with the same daily~          caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and~          hepatic fat content.~        2. characterize some of the mechanisms of action of different frequencies of meals (amount~          of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones,~          oxidation stress markers).~        3. test the ability of the participants to maintain hypocaloric diet on both regimens when~          educated and left to prepare their meals alone in comparison with those for whom all~          meals during the study will be provided.~      It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will~     change in a random order two regimens: six, and two meals a day. Each testing period will~     take three months.~      Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and~     after each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect~     calorimetry, MRI scan of the liver, DXA scan, serum concentration determination of selected~     adipokines, gut hormones, and oxidation stress markers).~      Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by~     periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast,~     frequent meals (and consequent higher plasma levels of insulin) will predispose to~     non-alcoholic fatty liver disease and insulin resistance. The investigators further~     hypothesize that the participants will increase their caloric intake with increased meal~     frequency (in spite of thorough education) when left to prepare their meals in comparison~     with those for whom all meals will be provided.~   "
135811|NCT01277458|"~     Are there differences between the way that non-White men who have sex with men living in~     London with HIV describe their own ethnicity and the way in which their ethnic group is~     recorded in NHS clinics? We aim to describe the way in which clinics in London currently~     record a patient's ethnic group. Without accurate data for an individual's ethnic group we~     are unable to draw meaningful conclusions about their experiences of HIV care. It may be the~     case that patients from particular ethnic groups require specific ways of monitoring and~     treating their HIV but without knowing if these people are in a particular group any~     services directed to them may be wasted or underused.~   "
135812|NCT01277445|"~     Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial~     gastrointestinal microbial populations. Prebiotic health claims are currently not permitted~     in Canada due to a lack of validating scientific data. Currently, Health Canada considers~     'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a~     human clinical trial to define the impacts of fructans on the colonic microbiome as well as~     the physiological, psychological and immunological effects on the host.~   "
135813|NCT01277432|"~     The investigators aim to:~        1. Estimate the prevalence of depression in a consecutive cohort of Chinese patients~          diagnosed with Type 2 Diabetes (T2D) living in areas of China with different~          socioeconomical affluence~        2. Examine patients' awareness of the frequent coexistence of these 2 conditions~        3. Analyze the associations between depression and T2D, in particularly the role of~          metabolic control, socioeconomical status and cognitive-psychological-behavioral~          factors~        4. To document the predisposing, precipitating and perpetuating factors for depression and~          their interrelationships in Chinese type 2 diabetic patients~   "
135814|NCT01277419|"~     The German Spondyloarthritis Inception cohort (GESPIC) was started as a prospective,~     longitudinal, multicentre, nationwide study in Germany on patients with early SpA including~     ankylosing spondylitis and non-radiographic axial. The objectives of GESPIC are to learn~     about the course of AS and other SpA during the very early stage of the disease, to~     appropriately assess the outcome including radiographic progression of patients after~     several years of follow-up, to identify outcome predictors, to assess quality of life,~     function, and costs (direct and indirect costs).~   "
135815|NCT01277406|"~     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201~     (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and~     safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal~     carcinoma.~   "
135816|NCT01277393|"~     This study is to find out care of critically ill patients enteral nutrition guidelines for~     the implementation of the effectiveness of the intervention.~   "
135829|NCT01277016|"~     In this multi-center phase III trial, untreated patients diagnosed with AL who are not~     candidates for stem cell transplant with melphalan 200 mg/m2 are the target population.~     Stage I and II patients will be eligible. Stage III patients will be enrolled in an~     ancillary phase II study. Eligible patients will be stratified as cardiac stage I or stage~     II and then randomized to receive MDex or BMDex.~      Primary objective is to compare hematologic(clonal) response i.e. the rate of complete~     response (CR) + partial response (PR) defined according to the criteria of the International~     Society for Amyloidosis consensus.~   "
135951|NCT01275430|"~     Phase I~        -  determine the location of the peripherally inserted central catheter (PICC) tip upon~          observation of maximum p-wave amplitude~      Phase II~        -  determine the precision of PICC placement in the Sherlock 3CG group versus the standard~          PICC placement~   "
135952|NCT01275417|"~     We are expecting that there are remarkable differences location at BaiHui(GV20) or~     Houding(GV19)showing from same person in our study.~   "
135817|NCT01277380|"~     The first outbreak of a new H1N1 influenza pandemic originated in the North America in April~     2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around~     the world and the mortality rate of was about 0.43%. Alignment and analysis on gene~     sequences of the new H1N1 influenza virus found that it contains extremely homologous gene~     composition with that of the swine influenza viruses (swine flu) identified in Europe and~     North America in last century. Thus the virus strain was later renamed as a novel influenza~     H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar~     to those resulted from seasonal influenza viral infection. Thus, it is difficult to~     distinguish the various influenza strains responsible for the infections only by clinical~     appearance. To compare the accuracy, specificity and sensitivity and speed in identifying~     the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza~     A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR~     method to further detect the presence of swine H1 gene. In addition, the titer of H1N1~     virus, the color development on the test stripe and clinical symptoms in patients were~     significantly associated. Finally, Real-time PCR products were subjected to sequence~     determination to explore potential new influenza pathogenicity, transmissibility and drug~     usage.~   "
135818|NCT01277367|"~     The aim of the study is to prospectively compare the effectiveness of diverse incentives on~     physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality~     health promotion programme based in South Africa.~   "
135819|NCT01277354|"~     The purpose of this study is to examine the effects of experiencing a previous pregnancy~     loss or complication on current physiological and emotional aspects of a current pregnancy.~   "
135820|NCT01277341|"~     This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.~   "
135821|NCT01277328|"~     This observational, prospective, open-label, multi-center study will evaluate the~     effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in~     patients with rheumatoid arthritis. Data will be collected for 11 months.~   "
135822|NCT01277315|"~     Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by~     a selective degeneration of the motor nerve cells in the cortex and myelon. As a result of~     motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,~     swallowing, and breathing musculature develops. ALS leads to death by respiratory~     insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved~     neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months.~     Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate~     liberated by activated microglia.~      The researchers propose an investigational therapy of ALS with subcutaneous administration~     of 100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the~     motor neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the~     autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical~     trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of~     inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1~     receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce~     motor neuron degeneration and disease progression.~   "
135823|NCT01277302|"~     This was a Phase IV multicenter, randomized, open-label study, with masking of the vision~     examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with~     macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein~     Occlusion (CRVO).~   "
135824|NCT01277289|"~     The aim of this study is the assessment of the efficacy of Ery-Dex (dexamethasone~     intra-erythrocyte) versus placebo in maintaining patients with steroid-dependent Crohn's~     disease in clinical remission throughout 12 months without oral steroids.~   "
135825|NCT01277068|"~     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.~     Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL~     particles is one of the characteristics, represents a major cardiovascular risk factor. The~     overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is~     recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL~     has been shown. In front of this important overmortality, the bariatric surgery quickly~     developed. Three main procedures are performed: 2 based exclusively on the gastric~     restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating~     a malabsorption (the gastric bypass).~   "
135826|NCT01277055|"~     Coronary artery disease (CAD) has a great significance concerning prevalence and mortality~     in the western world. It is usually diagnosed by catheterization and coronary arteries are~     visually assessed by the examiner. Thus having a great spectrum of interobserver~     differences, especially when it comes to intermediate lesions. The gold standard to assess~     the haemodynamic significance is the measurement of the myocardial fractional flow reserve~     (FFR). The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR-~     measurements in patients with intermediate lesions could significantly reduce stent~     implementation and consequently mortality. However this method is not used in daily routine~     and is available only in a fraction of catheter labs worldwide. Taking this into account~     decision finding especially in intermediate lesions remains difficult.~      One major step to simplify the invasive approach concerning intermediate lesions would be to~     establish a non-invasive procedures which localizes the coronary vessel to intervene ahead~     catheterization.~      Do to steady technical development cardiac MRI has become a powerful tool which is able to~     determine myocardial vitality, perfusion and function. In particular the new generation of 3~     Tesla multi transmit MR with its higher field strength and better spatial resolution seems~     to be able to show first pass myocardial perfusion more precise. With this new technology~     prefixed to cardiac catheterization clinical relevant information can be made accessible and~     thus reduce the number of unnecessary implemented stents.~   "
135827|NCT01277042|"~     This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human~     papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of~     subjects will receive the HPV vaccine and the other group will receive an active control~     (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be~     compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).~   "
135828|NCT01277029|"~     To identify the differences in psychopathology, personality traits among different female~     LUTS subtypes.~   "
135830|NCT01277003|"~     Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in~     clinical practice. Patients commonly experience a constellation of symptom complex brought~     on by compression of the median nerve as it traverse through the carpal tunnel. When~     compression of the nerve occurs, ischemia and mechanical disruption of nerve function may~     result. Pathological analysis shows a constellation of nerve injuries. Until now, no~     satisfactory conservative treatment method. Local steroid injections or oral steroids may~     result in initial relief, but relapses are frequent and have much side effects, which~     preclude their routine use for CTS. Full time wrist splints are claimed effective, but~     compromise hand function and daily activities. There are reasonable studies showing relief~     of pain with acupuncture on diverse pain conditions. However the therapeutic efficacy of~     acupuncture in CTS was less convincing in the past. Until recent decade, some case reports~     and few prospective studies reported the therapeutic effect of acupuncture in CTS. Other~     study also reported that low-level laser and microamperes transcutaneous electrical nerve~     stimulation (TENS) are effective in improvement of clinical outcome of patients with CTS.~     Another report suggested that TENS should be considered for the treatment of painful~     diabetic peripheral neuropathy. Therefore, the investigators perform this study to evaluate~     the effect of Aculife Magnetic Wave Therapist (a battery operated device with a probe~     electrode which contains magnetic elements that transform the oscillating current into an~     electromagnetic wave to stimulate the acupuncture points, simulate the effect of~     electroacupuncture ) on CTS and compared with that of Transcutaneous Electrical Nerve~     Stimulation(TENS). After at least 4 weeks treatment ( at least 16 treatment sessions) the~     therapeutic effects will be evaluated by comparison of symptom severity score,~     electrophysiological study, sonographic morphology study or magnetic resonance imaging~     study, before and after treatment, and between the different groups.~   "
135831|NCT01276990|"~     To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers~     following oral administration of repeated doses for 10 days within 8 dosing regimens.~   "
135832|NCT01276977|"~     The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs.~     eletriptan 40 mg tablet in the acute treatment of migraine.~      To develop and evaluate a set of importance weights for a predefined set of treatment~     attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg~     tablet.~      To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at~     early time points.~      To analyze the patterns of self-reported tolerability of migraine sufferers using~     zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.~   "
135833|NCT01276964|"~     Multicenter, observational, cross-over study intended to apply an easy and simple system for~     the quantitative determination of menstrual losses in women with apparently normal~     menses.The system adopted for the determination of menstrual losses, called QUEM~     (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in~     standard bags which are readily vacuum sealed with a simple device for the whole of woman's~     period. The evaluation will be performed for the whole of one period and the analysis will~     be performed in comparison to the classical reference method, the Alkaline - Hematin Method,~     which is still considered the golden standard.~   "
135834|NCT01276951|"~     In Colombia, ischemic heart disease and stroke are one of the most important causes of death~     in 45 years old people. Care of cases of disease represents high costs for the health system~     in particular and society in general, due to the loss of productive years life and costs for~     the care of the aftermath. Hypertension (HT) is one of the preventable risk factors for~     major cerebrovascular disorders. The pathophysiology of Essential hypertension is complex~     and depends of interaction of genetic and environmental factors. Among the determining~     elements are the increase in the activity of the sympathetic nervous system, the~     vasoconstricting and overproduction of hormones associated with sodium retention, disruption~     in renin secretion with increased production of aldosterone and angiotensin II, the~     deregulation of the kinins system, the increase in peripheral vascular resistance and~     activity of Growth factors in atherogenesis and vascular endothelial dysfunction, increased~     cardiac output, diabetes mellitus, obesity, and lower production of vasodilators such as~     brain natriuretic peptide (BNP), the prostacyclins and nitric oxide (NO), among others.~      Cocoa is a food rich in flavonoids, which stimulate the enzyme activity of endothelial~     nitric oxide synthase (e-NOS), responsible of the production of NO in vascular smooth~     muscle. The flavonoids modulate the synthesis of inflammatory substances that are derived~     from endothelial cells and the immune system.~      In a recent study found that with a few grams of cocoa achieves a significant reduction in~     blood pressure, so the investigators propose a controlled clinical trial to assess the~     effect of different doses of cocoa on blood pressure and endothelial inflammation in men~     with essential hypertension, stage I-II without target organ damage, in addition to~     pharmacologic monotherapy defined for the management of their disease. The investigators~     hope to determine an optimal dose of cocoa, with long-term effects, by their high content of~     flavonoids, improves cardiovascular and endothelial parameters with the advantage that it is~     an economical and easy introduction into the patient's habits.~   "
135835|NCT01276938|"~     Aim of the study is to evaluate toxicity in breast cancer patients treated with two~     different doses of Intra Operative Radiotherapy~   "
135836|NCT01276925|"~     Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is~     normally treated with opioids, which can cause side effects such as nausea, vomiting,~     obstipation and sedation. The hypothesis is that patients receiving peripheral nerve~     blockade of three nerves leading pain stimuli from the hip will experience less pain, will~     consume less opioid and therefore have less side effects, and will be mobilized more quickly~     than patients not receiving the peripheral nerve blockade.~   "
135837|NCT01276912|"~     -  Pre-diabetes is a significant risk factor for the development of type 2 diabetes, as~          well as macrovascular and microvascular complication.~        -  Previous studies show that 50% or more loss in islet B-cell function even in~          Pre-diabetes phase. The early insulin therapy in pre-diabetes may be a strategy in~          preventing metabolic disorders and cardiovascular disease.~        -  The objective of this study is to find if an initial insulin glargine intervention in~          pre-diabetes (IGT and /or IFG) could be a strategy in preventing type 2 Diabetes.~        -  Pre-diabetes subjects will receive a insulin glargine therapy with a dosage adjusted to~          get FBG ≤ 5.3mmol / L as the goal. Insulin glargine treatment will be maintained for~          three months thereafter to find if it can prevent diabetes.~   "
135838|NCT01276899|"~     This is a multicenter translational study to understand therapeutic resistance in patients~     undergoing standard chemotherapy for triple negative breast cancer.~      In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and~     banked before the start of chemotherapy and after the completion of the treatment~     (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples~     from metastatic lesions will be collected and banked before the start of chemotherapy and at~     the time of tumor progression. Additionally, blood samples will be drawn before treatment~     initiation (baseline) and at different time points during treatment. All samples will be~     stored in the Biological Resource Repository.~   "
135839|NCT01276886|"~     Patients were recruited over a four year period from 1996 to 1999. Those admitted in the~     years 1996 and 1997 were retrospectively accrued from the clinical records, while patients~     treated between 1998 and 1999 patients were entered on the database prospectively on~     admission.~      Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed~     clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or~     fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)~     either alone or in combination and/or by operative findings, entered the study. The CT~     criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and~     signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or~     extraluminal contrast. The criteria for ultrasound included at least two of the following~     signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema,~     intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for~     water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with~     or without a mass effect or extravasation of contrast and/or the presence of extraluminal~     air.~      Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome,~     colorectal cancer or diseases precluding adequate follow up, were excluded from the study.~      Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided~     abscess drainage) or surgically according to the local policy of each center.~      Follow up Follow up was carried out according to local policy. The following data were~     collected: persistence or recurrence of chronic symptoms attributable to complicated~     diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment~     and outcome.~      Recurrence was defined as a new episode of AD requiring hospitalization that occurred at~     least 2 months after complete resolution of the index episode which resulted in inclusion in~     the study. If surgery was performed, the timing, type of procedure, Hinchey stage and~     complications were recorded.~      Data collection A standardized flow sheet was used to collect data on medical history,~     diagnostic work up, type of treatment and follow up to create a dedicated database. Gender,~     age, date of hospital admission and discharge, diagnosis on admission and discharge,~     co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal~     failure), symptoms experienced before admission and their duration, history of~     diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were~     recorded. Where surgery was performed, the date and type of procedure, the operative~     findings including Hinchey's classification (16) and details of the operation (incision,~     extension of resection, type of anastomosis, covering stoma, drains), pathology report, and~     postoperative complications occurring within 30 days, were all recorded.~      End points The primary endpoint was to assess the rate of recurrence of AD requiring~     hospitalization during the follow-up period. Additional endpoints were to assess the risks~     of emergency surgery, stoma and disease-related mortality during the follow up.~   "
135868|NCT01276509|"~     Adults with Crohn's disease that is clinically active despite conventional treatment will be~     eligible for this study. Patients may receive one of three doses of PF-00547659~     (experimental drug) or placebo (inactive drug). Disease activity will be measured every two~     weeks.~   "
137555|NCT01254565|"~     The purpose of this study is to characterize the safety and tolerability and efficacy of~     multiple ascending doses of KAI-4169 in hemodialysis subjects for the treatment of secondary~     hyperparathyroidism.~   "
135840|NCT01276873|"~     To compare clinical effects identified in infants undergoing intratracheal aspiration with~     open and closed systems and verify the presence and intensity of pain in newborns during~     intratracheal suction, according to the system applied.Clinical, randomized, controlled, and~     crossover study, performed at two neonatal intensive care units after approval by the ethics~     committee. The sample consisted of infants from zero to seven days of age, 26 weeks of~     gestational age, and the exclusion criteria were use of mechanical ventilation with~     high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of~     circulatory failure, central nervous system disorders, without reactivity to stimulus,~     severe asphyxia, Apgar score less than three in the fifth minute, as well as, presence of~     chromosomal abnormalities and congenital malformations. After obtaining the informed consent~     from the responsible, children were randomly allocated into the experimental (CS) and~     control (OS) groups. The dependent variables of this study respiratory rate (RR), peripheral~     oxygen saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of~     the complementary variables, were collected through observation, the Premature Infant Pain~     Profile (PIPP) scale application and medical records consultation. During the data~     collection the period of variables observation were: T1 (immediately before suctioning), T2~     (during suctioning), T3 (immediately after) and T4 (10 minutes after). To the statistical~     analysis were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and~     Mann Whitney, settling at 0.05 level of significance.~   "
135841|NCT01276860|"~     Obstructive sleep apnea results in decreased attentiveness and response times in patients.~     The objective of this study is to quantify these consequences in pediatric OSA patients~     using an already established tool for examining the results of sleep deprivation and~     fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not~     been studied in pediatric OSA patients. This study aims to employ PVT along the normal~     course of diagnosis and treatment of pediatric OSA patients in our clinical practice at~     Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will~     exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be~     used to diagnose and monitor treatment outcomes in these patients.~   "
135842|NCT01276847|"~     This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the~     acquisition, handling and shipping procedure for skin biopsies obtained from participants~     with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In~     Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on~     biomarkers in lesional skin in participants with moderate to severe psoriasis will be~     evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to~     severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks.~     The primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA)~     expression of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon~     gamma (IFN-γ).~   "
135843|NCT01276834|"~     To compare in a prospective randomised way the effect of two different immunosuppressive~     regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery~     calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after~     transplantation.~   "
135844|NCT01276821|"~     To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity~     scores among children aged 6 weeks to 24 months with bronchiolitis.~   "
135845|NCT01276808|"~     Rationale: Magnetic navigation in complex lesions/vessels may result in reduced contrast and~     irradiation for patients undergoing percutaneous coronary intervention. The investigators~     aim to compare the use of the 2 techniques.~      Objective: To compare the use of contrast and irradiation used in magnetically navigated PCI~     (MPCI) with conventional guidewire PCI (CPCI) in patients with complex anatomy (as defined~     by a clinical prediction rule).~      Study design: Prospective randomised controlled, single-blind trial Study population:~     Healthy human volunteers aged 18 to 80 years of age Intervention (if applicable): One group~     has the placement of the angioplasty wire with magnetic navigation and the other has the~     angioplasty wire placed by conventional technique. All other interventions will be performed~     as per routine practice.~      Main study parameters/endpoints:~      Primary endpoint The primary endpoint is the amount of contrast used.~      Secondary endpoints~        1. Contrast needed to cross a lesion~        2. procedural time~        3. radiation exposure~        4. Clinical complications at 1 and 12 months~        5. procedural success~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The index procedure is performed as per normal routine and includes history and examination.~     A blood test will be taken once vascular access has been obtained. After the procedure a~     questionnaire will be filled in. The patient will have a blood test 2 to 3 days after the~     procedure, telephone follow-up will occur at 1 and 6 months and a further outpatient visit~     with ECG will be planned for a year after the index procedure. No additional significant~     physical or psychological discomfort is expected with participation in the study.~   "
135846|NCT01276795|"~     A prospective, randomized and controlled study is proposed to establish whether an enteral~     nutrition support regimen based on pressurized whey protein and glucose improves the~     postoperative utilization of amino acid substrates compared to a drink based on glucose~     alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino~     acid oxidation) will be investigated using stable isotope methodology before and after~     surgery in patients undergoing colon resection. Stable isotope infusions will be conducted~     one week before surgery and on the second postoperative day for two hours in the fasted~     state and for four hours while sipping the enteral nutrition support regimen. Patients will~     consume one of two enteral nutrition support regimens consisting of a drink containing~     either pressurized whey protein and glucose or glucose alone. It is hypothesized that an~     enteral nutrition support regimen based on pressurized whey protein and glucose promotes~     positive protein balance through increased protein synthesis or reduced protein breakdown~     compared to glucose alone.~   "
135869|NCT01276496|"~     This phase I trial studies the side effects and the best dose of cilengitide when given~     together with paclitaxel weekly in treating patients with solid tumors that have spread~     nearby or to other areas of the body and cannot be removed by surgery. Cilengitide may stop~     the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy,~     such as paclitaxel, work in different ways to the stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving cilengitide together with~     paclitaxel may kill more tumor cells.~   "
135847|NCT01276782|"~     The last two decades have witnessed an explosion of new research documenting the deleterious~     impact that thyroid disease has on pregnancy and the postpartum period, in relation to~     miscarriage preterm delivery intelligence quotient of the unborn child and health of the~     mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in~     euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5%~     of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm~     delivery.~      Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also~     been documented to negatively impact pregnancy. Women with Systemic lupus erythematosus~     (SLE)have increased rates of miscarriage and preterm delivery. Women with Systemic lupus~     erythematosus (SLE) also have increased rates of hypothyroidism and autoimmune thyroid~     disease (AITD, defined as the presence of thyroid antibodies with or without thyroid~     dysfunction). Preterm delivery (PTD), defined as birth prior to 37 weeks gestation, is the~     leading cause of neonatal mortality and morbidity in the United States. Although risk~     factors for preterm delivery exist, the majority of women have no known risk factors.~     Recently, both hypothyroidism and autoimmune thyroid disease have also been linked to~     preterm delivery. Given the increased prevalence of negative outcomes documented in pregnant~     women with thyroid disease, and the increased rates of hypothyroidism and Autoimmune thyroid~     disease in women with Systemic lupus erythematosus (SLE), the investigators determined that~     Autoimmune thyroid disease was associated with both preterm delivery and miscarriage. This~     has led to this application to begin a pilot randomized clinical trial of thyroxine in~     autoimmune thyroid disease in systemic lupus erythematosus pregnancy.~   "
135848|NCT01276769|"~     This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel~     plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized~     that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel~     plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and~     sensitive to carboplatin.~   "
135849|NCT01276756|"~     Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence~     (genotype 4), worldwide it also poses a significant health burden. To date standard of care~     treatment (pegylated interferon and ribavirin) give modest results with a sustained~     virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been~     used with an aim to improve current results. Recent reports have suggested an increased SVR~     with the addition of Nitazoxanide to standard of care. The results are preliminary and need~     to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to~     standard of care compared to standard of care alone.~   "
135850|NCT01276743|"~     The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a~     lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell~     activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different~     Caucasian populations.~      In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T~     polymorphism in T1DM predisposition in a Greek population.~   "
135851|NCT01276730|"~     The study objective:~        -  To evaluate the response and survival rates after treating stage III cervical cancer~          with retinoic acid and interferon-α combined with radiotherapy in the study group.~        -  To evaluate the response and survival rates after treating stage III cervical cancer~          patients with concomitant cisplatin and radiotherapy in the control group.~        -  To evaluate the safety and tolerability of the combination of retinoic acid,~          interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.~        -  To determine if there is an immune response to Human Papillomavirus (HPV) by estimating~          serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and~          after treatment.~      The study hypothesis:~        -  The response rates and survival rates of retinoic acid and interferon-α combination~          with radiation will be better than chemo-radiation to treat stage III cervical cancer.~        -  Treatment with the retinoic acid, interferon-α and radiation combination therapy will~          be less toxic and better tolerated than chemo-radiation therapy.~   "
135852|NCT01276717|"~     This will be a phase I study of carfilzomib in combination with vorinostat in patients with~     relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171~     and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs~     can also synergize powerfully to induce cell death in bortezomib-resistant cells. The~     purpose of this study is to see if vorinostat can combine with carfilzomib and to safely~     find the recommended phase II dose.~   "
135853|NCT01276704|"~     The investigators would like to see if women at increased risk for breast cancer are likely~     to tolerate SDG daily for 12 months without significant side effects or changes in their~     menstrual cycles. The investigators would also like to determine if Brevail® can reduce~     breast cell proliferation in pre-menopausal women.~   "
135854|NCT01276691|"~     The investigators hypothesize that~        1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet~          activation, platelet aggregation, and clotting potential, b) increased fibrinolytic~          potential following fire fighting, c) no significant effect on endothelial function or~          arterial stiffness versus the placebo condition.~        2. chronic treatment with low-dose aspirin will lead to a) decreased resting and fire~          fighting induced platelet activation, platelet aggregation, clotting potential, b)~          increased fibrinolytic potential, and c) increased endothelial function and decreased~          arterial stiffness in response to live fire fighting versus the placebo condition.~        3. short-term fire fighting activity will result in: a) a reduction in arterial function~          (reduced endothelial function, increased augmentation index and an attenuated arterial~          stiffness response); b) a disruption in hemostasis that is characterized by an increase~          in platelet number and function, an increased coagulatory potential and altered~          fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic~          inflammation, monokine chemoattractant protein, and matrix metalloproteinases.~   "
135855|NCT01276678|"~     About 13 million people in the United States have coronary artery disease (CAD). It is the~     leading cause of death in both men and women.~      Coronary artery disease (CAD) occurs when the blood vessels that supply blood to the heart~     muscle (the coronary arteries) become hardened and narrowed. The arteries harden and narrow~     due to buildup of fatty and calcified material called plaque on their inner walls. The~     buildup of plaque is also called atherosclerosis. This is a process which starts early in~     life, but can be influenced by multiple factors.~      Several factors increase the risk of developing atherosclerosis. They include high blood~     pressure, smoking, diabetes, high cholesterol and being related to someone who had a heart~     attack or a stroke. The more risk factors you have, the greater the chance that you have~     severe atherosclerosis. Some of the risk factors cannot be modified, like age and family~     history of early heart disease. The influenceable factors include high blood pressure, high~     blood cholesterol, high blood sugar, cigarette smoking, overweight or obesity, and lack of~     physical activity.~      Nevertheless, there are patients without any above mentioned risk factors who develop~     atherosclerosis. In addition to that, there are also patients with several risk factors who~     do not develop severe coronary artery disease.~      According to research studies high blood levels of some substances in the blood (biochemical~     markers) as well as some genes in the DNA of our cells may be associated with an increased~     risk of developing CAD and faster progression of the disease.~      The purpose of this study is to find a correlation between certain blood markers and growth~     of the plaques, regardless of the presence of the classic risk factors for atherosclerosis.~     If we prove our hypothesis we will be one step closer to predicting the extent of~     atherosclerosis by performing certain blood tests.~   "
135856|NCT01276665|"~     Perioperative fluid management in abdominal surgery is a subject of controversy and current~     standard fluid therapy is not evidence based. Compensating decreasing blood pressure by~     volume substitution is common praxis. Alternatively the fall in blood pressure due to~     vasodilatation can be corrected by applying vasoactive agents. A review of the data on the~     effect of high volume perioperative fluid therapy suggests that overhydration may have~     deleterious effects on cardiopulmonary function as well as on recovery of gastrointestinal~     motility, tissue oxygenation and wound healing. Restrictive fluid administration in~     fast-track surgery led to no differences in all-over recovery after colonic surgery. Based~     on our current knowledge, a low volume regimen combined with a noradrenaline perfusor may be~     of benefit during open radical cystectomy. It seems of interest and safe to use a~     noradrenaline perfusor combined with a low volume regimen during open radical cystectomy.~     The low volume regimen, as described in this study protocol, is well established at our~     institution, which has a large experience in cystectomy.~      The aim of this study is to compare intraoperative blood loss, quality of the surgical~     field, metabolic response, pain relief, fatigue score, gastrointestinal function,~     cardiovascular, pulmonary, infectious and surgical complications as well as cognitive~     function in two groups of patients undergoing radical cystectomy.~      The investigators expect a lower complication rate in the restrictive fluid regimen group~     and better surgical conditions. This could significantly affect short- and long-term outcome~     of patient undergoing major cancer surgery, have an impact on survival and financial~     consequences.~   "
135857|NCT01276652|"~     This study examines the feasibility of assessing sleep and circadian rhythmicity in~     critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the~     feasibility of reducing subject exposure to environmental light and noise and of delivering~     routine care according to classical day/night routines.~   "
135858|NCT01276639|"~     The main objective of this study is to compare the effects of CP-690,550 with the effects of~     placebo in patients being treated for moderate to severe chronic plaque psoriasis. This~     one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.~   "
135859|NCT01276626|"~     The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum~     (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome~     (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood,~     memory, general well-being and bowel symptoms will be assessed before, at the end of the~     treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic~     profile and inflammatory markers will be also measured.~   "
135860|NCT01276613|"~     The goal of this clinical research study is to learn if gemcitabine can enter pancreas~     cancer cells.~   "
135861|NCT01276600|"~     Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate~     (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human~     participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.~   "
135862|NCT01276587|"~     This pilot study aims to answer the question whether monthly oral vitamin D3~     supplementation, 100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D~     (form of vitamin D measured in the blood) to levels considered sufficient (30 ng/mL) but~     well below the threshold for toxicity (150 ng/mL) in children with sickle cell disease.~     Information from this study will be crucial before we perform a larger clinical trial to~     determine the effects of vitamin D in reducing respiratory complications in patients with~     sickle cell disease.~   "
135863|NCT01276574|"~     The purpose of this study is to determine, whether there is clinical benefit of using~     fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed~     tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial~     ovarian cancer (EOC)~        -  Objectives~             -  the impact of preoperative PET/CT compared to CT on EOC stage definition~             -  to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal~               tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic~               results serve as the reference standard.~             -  to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen~               125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant~               chemotherapy and primary treatment of EOC~        -  Methods~             -  All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant~               chemotherapy (NACT) and 4 weeks after completion of primary platinum-based~               chemotherapy.~             -  CA125 and HE4 levels are measured pre-operatively and with every chemotherapy~               cycle.~   "
135864|NCT01276561|"~     This is a prospective trial of single incision versus standard 4-port laparoscopic~     splenectomy.~      The hypothesis is that there may be a difference in wound infection rates, operative time,~     doses of analgesics post-operatively, and patient/parent perception of scars. However, the~     technical difficulty is considerable and the primary outcome is operative time which will be~     expressed in minutes.~   "
135865|NCT01276548|"~     The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of~     Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline~     Treatment in Subjects With Ovarian Cancer.~   "
135866|NCT01276535|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in the treatment of acne blemishes.~   "
135867|NCT01276522|"~     Schnitzler syndrome is a disabling inflammatory disease, characterized by chronic urticaria,~     fever, arthralgia, bone pain and gammopathy, which can so far only be effectively treated~     with anakinra, an interleukin-1 receptor antagonist. However, this drug is not registered~     for use in Schnitzler syndrome, and it needs to be injected daily, which is uncomfortable~     and unpractical. Therefore other treatments targeting IL-1 are needed. Canakinumab is a~     long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in~     the rare autoinflammatory disease Cryopyrin-associated periodic syndrome (CAPS). We~     hypothesize that it will be effective in Schnitzler syndrome too in view of clinical~     similarities to CAPS and the targeting of IL-1B, which is also blocked by anakinra (which~     blocks both IL-1B and IL-1A).~      This is a 6-month open-label, single treatment arm study of canakinumab 150 or 300 mg (in~     case of insufficient response to 150 mg) subcutaneous injection once per month in patients~     with active Schnitzler syndrome, in which efficacy and safety will be assessed.~   "
135871|NCT01276470|"~     Background:~        -  Like other complex diseases, autoimmune diseases are the result of numerous causes,~          including genetic and environmental factors. Some researchers believe that people who~          are susceptible to autoimmune disorders develop them when the body reacts to~          environmental or other factors by creating white blood cells that attack the body s own~          tissues, which then progresses to autoimmune diseases. These immune-triggered disorders~          can overlap with one another to some extent, but most autoimmune diseases have certain~          distinct triggers.~        -  The autoimmune disorder myositis weakens the muscles and may cause other health~          problems. Environmental exposures associated with myositis include ultraviolet~          radiation, stressful life events and muscle overexertion, collagen implants, infections~          such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some~          individuals with myositis also produce proteins in the blood called autoantibodies that~          react with certain parts of the person s own cells, called synthetases, which are~          involved in making new proteins. A syndrome called the anti-synthetase syndrome, which~          includes myositis and lung disease, is associated with having the anti-synthetase~          autoantibodies. Researchers are interested in studying differences in environmental~          exposures in individuals with myositis. This study is being conducted to determine if~          persons with the anti-synthetase syndrome have had different environmental exposures~          before disease onset compared with other patients with myositis who do not have this~          syndrome and also compared with healthy volunteers.~      Objectives:~      - To determine whether selected infectious and noninfectious environmental exposures are~     more common in individuals who have myositis with the anti-synthetase syndrome, compared~     with healthy volunteers.~      Eligibility:~      - Individuals who have been diagnosed with myositis (with or without anti-synthetase~     autoantibodies), and healthy volunteers without autoimmune disorders.~      Design:~        -  Participants will be screened with a full medical history and physical examination, and~          will provide blood, urine and house dust samples.~        -  Participants will complete questionnaires about their medical history and the types of~          exposures they have had at work, at home, and elsewhere. Participants who have myositis~          will also be asked about certain infections, heavy exercise or physical exertion, sun~          exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with~          the disease. Healthy volunteers will be asked about the same exposures before the date~          of diagnosis of disease of the myositis subject to which they have been matched.~        -  Participants will receive a kit that contains instructions and a filter to be put onto~          their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for~          possible future analyses of infectious or toxic agents based on the other results from~          the study.~        -  Individuals with myositis will have other tests as clinically indicated, including lung~          function tests and imaging studies.~   "
135872|NCT01276457|"~     The purpose of this study was to allow the continuation of everolimus treatment in patients~     who have completed the core study (NCT00170885) and to collect long-term safety,~     tolerability, and efficacy data in a group of patients treated with the upper everolimus~     target levels plus very low dose cyclosporin in comparison with the standard everolimus~     target levels plus low dose cyclosporin in patients with renal transplantation.~   "
135873|NCT01276444|"~     Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of~     current cardiosurgical practice.~      Several approaches were introduced into the clinical practice to alleviate systemic~     inflammatory response induced by cardiopulmonary bypass and organ-specific injury including~     meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of~     anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic~     hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular~     permeability is of a great clinical value to control the efficacy of these approaches.~      Therefore, the aim of this study was to compare two algorithms of goal-directed therapy~     aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.~   "
135874|NCT01276431|"~     An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and~     safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe~     osteoarthritis pain of the hip and/or knee.~   "
135875|NCT01276418|"~     This study is intended to collect data regarding treatment with a new flexible fiber used to~     transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study~     will include a single treatment that is performed transorally (through the mouth) for oral~     or laryngeal indications in the field of Ear, Nose and Throate (ENT).~   "
135876|NCT01276405|"~     This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of~     disease-free survival in patients with colon cancer stage III (Duke C) after surgical~     resection. Data will be collected for 3 years.~   "
135877|NCT01276392|"~     Actual clinical practice predominantly makes use of heparin (systemically) or citrate~     regionally as anticoagulation in the extracorporeal circulation for renal replacement~     therapy. We aim to find out if different anticoagulation strategies may lead to different~     levels of platelet activation and whole blood coagulation. Regarding coagulation activation,~     it remains uncertain if there is an advantage for one of these methods. However, it is of~     major interest to minimize the risk of any additional clotting activation via extracorporeal~     circulation in these usually critically ill patients.~   "
135878|NCT01276379|"~     Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients~     is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures~     (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments~     (surgery or local-ablative therapies). Additionally, 10-15% of patients have poor~     performance status (PS >2) or are severe disabled due to geriatric syndromes or/and~     co-morbid diseases that preclude any treatment strategies than best supportive care alone.~     The rest of patients (fit patients not suitable for radical treatments) constitute the~     population of patients treated with palliative therapies. Despite of it not all these~     patients have the same prognosis. Patients with PS 0,1 and levels of LDH <ULN~     (Intermediate-risk patients) have better PFS and OS irrespective of therapy in all~     randomized clinical trials (de Gramont et al, JCO 2000; Douillard et al, Lancet 2000;~     Koopman et al, 2007).~      CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab~     compared with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is~     based on mutational status of KRAS, which allow to select those patients who will not~     respond to therapy. Other surrogate markers of activity should be also evaluated. Our~     hypothesis is that the suggested biomarkers will allow the selection of the patients who~     will benefit the most from the biweekly cetuximab treatment.~   "
135879|NCT01276366|"~     Last thirty years, many research was performed concerning pain in the newborn. These~     investigations showed us the negative effects of pain in the neonatal period. Our research~     concerns the choice of analgesics for the premature newborn during a heel lance. Newborns~     with a gestational age of 32-37 weeks are randomly assigned over three groups. They can~     receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or~     sucrose.~      The primary objective of the Amphia Premature Infant Pain study, is to investigate whether~     there is a difference in PIPP-scores in premature newborns who undergo a heel lance,~     receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in~     newborns receiving breast milk compared to sucrose. And the investigators presume that~     breast feeding has the same analgesic effect as giving supplemental breast milk.~   "
135880|NCT01276353|"~     The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the~     currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with~     severe Alzheimer's disease.~   "
135881|NCT01276340|"~     The investigators performed a prospective analysis of 450 women with stress, urge and mixed~     incontinence in order to assess the health-related quality of life (Contilife®~     questionnaire) and the objective cure rate after two months of electrical stimulation (Keat®~     stimulator). Management of urinary incontinence with the Keat® stimulator could given an~     improvement in the quality of life and a good rate of satisfaction without side effect.~      Objective cure is as good as subjective improvement especially in urinary stress~     incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the~     bew first-line non surgical treatment for female urinary incontinence.~   "
135882|NCT01276327|"~     The objective of the current study is to establish the bioequivalence of linagliptin/~     pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and~     pioglitazone administered together.~   "
135883|NCT01276314|"~     Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has~     the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond~     to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%).~     Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic~     Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are~     (1) to compare the effect of treatment between systemic steroid and anti-TNF α. Including~     skin re-epithelization time, internal organ recovery time, mortality rate, and (2) to~     investigate the pathogenesis of severe cutaneous adverse reaction.~   "
135884|NCT01276301|"~     Relative bioavailability of BI 10773 given alone and together with verapamil~   "
135885|NCT01276288|"~     The primary objective of the study is to investigate the effect of BI 10773,~     hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore~     the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should~     be assessed.~   "
135886|NCT01276275|"~     The purpose of the study is to describe patient characteristics and drug usage among~     patients that are prescribed ticagrelor for the first time and to compare them with patients~     who are prescribed clopidogrel and prasugrel for the first time.~      A further purpose is to ascertain and estimate the crude incidence rate of bleeding,~     arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout~     among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.~   "
135887|NCT01276262|"~     A crossover study to assess the effect of repeated doses of fostamatinib on the levels of~     oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will~     consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days~     each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib.~     The study will also evaluate the safety and tolerability of fostamatinib in combination with~     an oral contraceptive~   "
135888|NCT01276249|"~     The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the~     clinical knowledge base by including 'real world' subjects.~   "
135889|NCT01276236|"~     The purpose of this study is to determine whether Maraviroc is effective in the treatment of~     Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug therapy.~   "
135890|NCT01276223|"~     The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective~     in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog~     Scale (VAS) discomfort score.~   "
135891|NCT01276210|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic~     radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to~     normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib~     tosylate when given together with SRS in treating patients with brain metastases~   "
135892|NCT01276197|"~     The purpose of this study is to determine if patients with high blood pressure are better~     able to control their blood pressure after watching a DVD about blood pressure.~   "
135893|NCT01276184|"~     Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent~     females in the United States. Our primary objective is to determine if Short Message Service~     (SMS) text message reminders increase adherence to the recommended 3 dose schedule for~     Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of~     this study are: 1) to demonstrate the feasibility of using SMS text message reminders to~     increase adherence with Gardasil vaccination; and 2) to assess satisfaction and~     acceptability of text message reminders compared to telephone reminders among women who~     receive the text message arm of the intervention. The investigators hypothesize that~     receiving SMS text message reminders will increase adherence to the recommended 3 dose~     schedule for Gardasil compared to usual care.~   "
135894|NCT01276171|"~     Radial arterial cannulation is a common invasive procedure for real-time measurement of~     arterial blood pressure. Placement of the arterial catheter using conventional palpation is~     often relatively easy and quick, but this is not always true. A relatively new method for~     direct visualization of the artery is the use of two-dimensional ultrasound. This technique~     allows cannulation of the artery to take place under real-time visualization and may~     increase the success rate of first time pass of the needle. Another technique utilizing~     Doppler has also proven to be effective in cannulating the radial artery. This technique~     utilizes changes in acoustic pitch as the probe passes directly over the artery. The primary~     objective of this study is to compare the first attempt success rate for radial artery~     cannulation among the palpation, Doppler and U/S guided technique when applied by trainees.~     Secondary outcomes include: success rate within 5 minutes, successful, number of attempts~     required, and correlation between success rate and operator experience for successful~     cannulation of the radial artery.~   "
135895|NCT01276158|"~     In infants, percutaneous cannulation of radial artery requires considerable expertise.~     People have been using Doppler guided radial artery cannulation technique to improve success~     rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central~     line placement in pediatrics. The purpose of this study is whether ultrasound guided radial~     artery cannulation technique improves the success rate compared to traditional doppler~     guided technique.~   "
135896|NCT01276145|"~     Subjects in this study have recently had or are scheduled for a coronary angiography as part~     of their normal, routine medical care. This procedure uses x-ray imaging to see the inside~     of the heart's blood vessels.~      This research study will evaluate the possible relationship between erectile dysfunction and~     vascular disease (diseases of the veins). In order to look at this possible relationship,~     subjects will complete a questionnaire which will ask questions regarding their sexual~     activity. Additionally, we will gather information from their medical records and take extra~     images during the coronary angiography procedure.~   "
135897|NCT01276132|"~     Subjects in this study have recently had or are scheduled for a (percutaneous coronary~     intervention) PCI as part of their normal, routine medical care. This procedure should~     restore the blood flow in the vessels of the heart.~      Recent studies have shown that stable patients who undergo PCI and are discharged home after~     4 hours of observation do not suffer any more complications compared to patients who stay in~     the hospital overnight. In addition, studies suggest that patients express increased~     satisfaction at being discharged after 4 hours.~      The University of Chicago is one of the first US medical centers to institute a formal~     program of same-day discharge after PCI. This study will seek, through a analysis of medical~     information and satisfaction questionnaires, to assess whether this particular same-day~     discharge program can improve patient satisfaction and preserve patient safety.~   "
135898|NCT01276119|"~     To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by~     intravenous infusion (iv) and subcutaneous (sc) injection.~   "
135899|NCT01276106|"~     This is a 24-week randomized placebo-controlled study to investigate the effect of an oral~     IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on~     different background diabetes therapies.~   "
135900|NCT01276093|"~     The purpose of the study is to demonstrate that in patients of 70 years or older with~     symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF~     ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of~     AF.~   "
135901|NCT01276080|"~     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose~     crossover study was conducted to compare the relative bioavailability of equal doses of the~     test and reference products under non-fasted conditions.~   "
135902|NCT01276067|"~     This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose~     crossover study was conducted to compare the relative bioavailability of equal doses of the~     test and reference products under fasted conditions.~   "
135903|NCT01276054|"~     Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity~     of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or~     axillary lymph node biopsy with or without axillary reverse mapping works in reducing~     incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer~   "
135904|NCT01276041|"~     The purpose of this study is to see if a combination of drugs can help to treat this type of~     cancer. One drug is a chemotherapy agent called paclitaxel (Taxol®). Paclitaxel will be~     given every week through the vein. Although the weekly schedule of paclitaxel is not~     included in the label, the schedule and dose of weekly paclitaxel have been studied and have~     been proven to be more effective than an old standard schedule. The other two work against~     HER2. One is called trastuzumab (Herceptin®) and it is commonly given to women with early~     HER2 positive breast cancer or with advanced HER2 positive breast cancer that has spread to~     other parts of the body. Trastuzumab will be given through the vein every 3 weeks (or every~     week at the doctor's discretion). The third drug, pertuzumab, is an investigational drug. It~     has not been approved by the Food and Drug Administration. It has been given in studies to~     over 800 people. It has been effective in treating HER2 positive breast cancer. Pertuzumab~     will be given every 3 weeks through the vein. This study is looking at the effectiveness of~     these three drugs together.~   "
135905|NCT01276028|"~     The primary purpose of this study is to determine the effectiveness of acupuncture for~     treating vasomotor and other symptoms associated with menopause as acupuncture is generally~     practiced in the real world setting and to obtain a comprehensive assessment of use~     patterns and symptom relief over time. This study will allow us to determine treatment~     patterns recommended by practicing acupuncturists, adherence to these treatments, and the~     effectiveness of different treatment patterns for reducing hot flashes. Results of this~     study will provide meaningful information to women in terms of number and frequency of~     acupuncture treatments likely to be needed to reduce hot flashes.~   "
135906|NCT01276015|"~     Objectives. To study the short-term neurophysiological and clinical outcome of botulinum~     toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring~     uninjected muscles in children with cerebral palsy.~      Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus~     foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was~     injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological~     outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral~     gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side~     before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical~     scales were assessed and video gait was analyzed at all three time points.~      Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side~     decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002).~     Assessment at both time points after injections also showed that ankle spasticity had~     diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved~     (p<0.05).~      Conclusion. Although BoNT-A injected at standard doses improves gait in children with~     spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for~     cerebral palsy therefore needs individualizing according to the child's clinical features.~   "
135907|NCT01276002|"~     The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and~     persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized~     studies have been conducted on the influence of pancreatic duct stenting for the patients`~     benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively~     in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether~     pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker~     clinical recovery and avoidance of recurrence of pancreatic pseudocysts.~   "
135908|NCT01275989|"~     Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear~     and effective in reducing these levels. The LSS questionnaire and IDATE state were applied~     before, two months and two and a half months after the start of the applications, the STAI~     trait was applied once prior to the sessions. The sample comprised 56 individuals who had~     higher levels of stress above the average LSS 100 students who answered the questionnaires.~     Participants were divided randomly into three groups: control group with 15 patients without~     care, intervention group with 20 individuals using specific points for treatment and Group~     Sham at 21 points using individuals without indication for treatment of anxiety and stress.~     The results showed that the sham points decreased anxiety levels of participants.~   "
135909|NCT01275976|"~     Trauma and major operation are associated with an excessive inflammation reaction due to~     tissue injury. This overwhelming immune response is considered to be a major risk factor in~     the pathogenesis of late inflammatory complications such as acute respiratory distress~     syndrome (ARDS), multiple organ dysfunction syndrome (MODS) and sepsis.~      The investigators hypothesize that administration of C1-esterase inhibitor (C1-INH) will~     attenuate the humane inflammatory response and, thereby, reduce the risk of inflammatory~     complications due to surgical interventions in trauma patients with a femur or pelvic~     fracture~   "
135910|NCT01275963|"~     Assessment of left ventricular systolic function is the most frequent indication for routine~     echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both~     measuring radial ventricular function, are the currently recommended methods to meet this~     challenge. Due to the complexity of the myocardial architecture, global left ventricular~     function also has longitudinal and torsional components.~      The aim of this study is to evaluate new echocardiographic parameters for longitudinal left~     ventricular function. A special focus is set on strain imaging by speckle tracking, which is~     a relatively new technique. Patients with different cardiac pathologies (e. g. dilated~     cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and~     compared to healthy individuals.~   "
135911|NCT01275950|"~     The Project aims at enlisting the outlets selling tobacco in any form and enlisting the~     tobacco based advertisements (Direct and Surrogate) directed towards the community, within~     100 yards of the selected educational institutes and studying their impact on the students~     of that institute. This will further be followed by an intervention program directed at the~     outlet owners which entails creating awareness about the harmful effects of tobacco and the~     existing bill and thereby assessing any change in Knowledge, Attitude and Practice. The~     results thus obtained will facilitate implementation of the existing Bill.~   "
135912|NCT01275937|"~     A bleeding peptic ulcer remains a serious medical problem with significant morbidity and~     mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality~     in patients with bleeding peptic ulcers and is now recommended as the first hemostatic~     modality for these patients.~      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after~     endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been~     supported in the management of these patients.~      The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in~     this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All~     patients receive successful endoscopic therapy with heater probe or hemoclip placement.~      In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the~     patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65),~     160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40~     mg nexium orally daily for two months.~      The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,~     volume of blood transfused, number of surgeries performed, and the mortality rates of the~     two groups are compared as well.~   "
135913|NCT01275924|"~     Syndesmotic injuries are common and often associated with unstable ankle fractures. The most~     common treatment is with a syndesmotic screw through the fibula and tibia which is later~     removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples,~     Florida). is used for the same indication, it consists of a heavy suture placed across the~     syndesmosis which has been looped and tightened through cortical button anchors on either~     side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial~     compares these two treatment methods for syndesmotic injuries of the ankle.~   "
135914|NCT01275911|"~     In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as~     alternative to intraoperative opioids, is tested in patients undergoing laparoscopic~     prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The~     purpose of this study is to determine whether intravenous esmolol improves postoperative~     analgesia and accelerate the surgical recovery. We hypothesize that patients receiving~     intravenous esmolol will consume less analgesic in the postoperative period, will have less~     opioid-related side effects and will recover their functional status faster then patients~     receiving intravenous esmolol.~      Patients will be stratified according to the type of surgical procedure in 2 arms: 40~     patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40~     patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen~     funduplication) will be enrolled.~      Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group,~     n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).~   "
135915|NCT01275898|"~     Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices~     are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed~     to influence cerebral oxygenation. Litte is known about the influence of prone position and~     head down position on cerebral oxygenation. The investigators hypothesize that these~     positions influence cerebral oxygenation. Further the investigators presume that the two~     cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.~   "
135916|NCT01275885|"~     The aims of the present study are to evaluate the concentrations of vitamin D in the plasma~     and of calcium in the plasma and in the urine as well as to evaluate bone mineral density~     using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D~     with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended~     supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is~     given to infants from 2 weeks of age to 3 months of age.~   "
135917|NCT01275872|"~     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle~     Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit,~     anxiety and depression in patients with either prostate or breast cancer.~      This study includes a total of 200 patients with prostate and breast cancer randomly~     assigned to either a control or intervention group.~      The intervention group received in total 4 sessions of Guided Imagery (protocol floating on~     a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of~     muscle progressively tensing and relaxing).~      Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and~     quality of life. Additionally, saliva samples were collected prior and after the sessions as~     to assess saliva cortisol and saliva α-amylase.~      The same measurements were received by the patients of the control group as to allow~     comparisons.~   "
135918|NCT01275859|"~     Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems~     to play a crucial role in breast cancer progression and endocrine resistance.Combined~     HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive~     postmenopausal breast cancer might enhance response and block emergence of endocrine~     resistant tumor.~   "
135919|NCT01275846|"~     This purposed of this study is to ascertain if the implementation of remote patient~     management systems utilizing American Heart Association (AHA) guideline-based heart failure~     protocols and educational content can improve the management of patients with congestive~     heart failure.~   "
135920|NCT01275833|"~     The objective of the trial is to observe the effects of restoring atrioventricular (AV)~     synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and~     chronically using echocardiographic and functional measurements.~   "
135921|NCT01275820|"~     The purpose of this study is to evaluate how an investigational food product affects a~     healthy person's blood sugar and insulin levels.~   "
135922|NCT01275807|"~     The purpose of the investigators study is to create the evidence of effectivness on~     climacteric syndrome in patients affected by breast cancer, by acupuncture added to the~     standard care (self care).~   "
135923|NCT01275794|"~     The purpose of the study is assessment of glycemic control and physicians satisfaction with~     results of DM2 OAD monotherapy~   "
135924|NCT01275781|"~     The purpose of this study is to assess distribution, metabolism, and excretion of~     radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.~   "
135925|NCT01275768|"~     Patients with malignant obstructive jaundice (cancer of head of pancreas and~     cholangiocarcinoma) generally have a very poor prognosis with less than 20% patients having~     resectable disease at presentation. These patients also have a very poor quality of life~     with a life expectancy of 6-8 months. Jaundice associated with pruritus, poor appetite,~     malabsorption and loss of weight and cholangitis is the most common and troublesome problem.~     Placement of metallic stents has been the standard of care for patients with unresectable~     disease. However, about 50% of these stents get blocked in 6-8 months. Use of endoscopic~     Radio-frequency Ablation (RFA) prior to placement of metal stents may increase the patency~     of these stents~   "
135926|NCT01275755|"~     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and~     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI~     tract. The most common symptoms associated with the effects of opioids are constipation and~     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of~     long-term opioid therapy.~      The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist,~     with placebo in the treatment of opioid-induced constipation (OIC) in adults taking~     long-term opioid therapy for chronic noncancer pain.~   "
135927|NCT01275742|"~     Heart failure (HF) affects 5 million people in the US and is the most common cause of~     hospitalization in elderly adults. One-third of patients who are hospitalized with HF have~     major depression. Depressed HF patients have double the rates of morbidity and/or mortality~     and worse health-related quality of life than non-depressed HF patients. The investigators~     previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may~     improve short-term cardiac survival among depressed hospitalized HF patients compared to~     non-depressed HF patients who received usual care. Therefore, the investigators will conduct~     a larger study to evaluate the effects of the intervention on longer cardiac event-free~     survival, symptoms of depression, health-related quality of life, and stress levels in~     patients with HF. The investigators hypothesize that patients in the intervention group will~     experience longer cardiac event-free survival, lower levels of depressive symptom, better~     health-related quality of life, and lower salivary cortisol levels at follow-up than~     patients who receive usual care.~   "
135928|NCT01275729|"~     The primary objective is to safely determine if the investigators can identify the severity~     of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the~     investigators will draw blood and urine for novel and standard biomarkers. The investigators~     are attempting to determine if these biomarkers can forecast the course of AKI (need for~     dialysis, death and renal recovery). The investigators seek to determine how well physicians~     caring for those with AKI can predict the clinical course compared to these novel biomarkers~     of AKI and if there is an association between clinical course and 3 year patient outcomes.~   "
135940|NCT01275573|"~     Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain~     perception was altered in Parkinson's disease patients and could be related to nociceptive~     cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an~     electrophysiological tool which can modify cortical excitability. Its efficacy was~     demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In~     this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be~     evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain~     free Parkinson's disease patients. Each group will receive a high frequency Repetitive~     Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of~     one week.~      The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session~     with an infraliminary intensity on the primary cortical motor, modulating nociceptive~     cortical areas activity, could modify the nociceptive threshold perception in Parkinson's~     patients.~   "
137592|NCT01254019|"~     The purpose of this study is to determine whether GSK2402968 is effective in the treatment~     of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be~     corrected by exon 51 skipping.~   "
135929|NCT01275716|"~     Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there~     is a build-up of fatty material in the wall of the heart arteries that causes narrowing of~     the arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or~     permanent damage to the heart. As part of their normal routine care, subjects had or will~     have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of~     their heart. During a PCI procedure, pictures are taken of the arteries before and after the~     treatment of the narrowing in the arteries. These pictures are acquired through angiography~     which is a way to produce X-ray pictures of the inside of arteries.~      After a PCI procedure, there is a possibility for narrowing of the arteries to return. The~     likelihood of this happening can be greatly reduced by lifestyle changes and adhering to~     heart medication regimens. It is part of normal, routine care for CAD patients to be given~     written and verbal information on how to lead a heart healthy lifestyle and to take heart~     medications properly.~      In this research study, the investigators will show half of the patients their before and~     after images of their heart arteries where the narrowing occurred and was treated. The other~     half of the patients will not be shown these images. Both groups will still receive~     information about lifestyle and medications as part of their normal, routine care. At the~     end of this study, the investigators will compare both groups to see if there are any~     differences in making lifestyle changes and taking heart medications properly. Additionally,~     the investigators would also like to see if there are any resulting differences in the~     amount of hearts attacks or other heart related medical events.~   "
135930|NCT01275703|"~     Subjects in this study have been diagnosed with pulmonary hypertension and their doctors~     have referred them for an exercise test as part of their normal, routine care. The exercise~     test will either be a treadmill test or a 6 minute walk test. During a treadmill test, a~     patient typically walks on a treadmill while their heart is monitored using an~     electrocardiogram, which records the electrical activity of the heart through 10 small~     electrode patches attached to the skin of the chest, arms and legs. Additionally, heart rate~     and blood pressure are monitored throughout the test. A 6-Minute Walk test requires patients~     to walk for up to 6 minutes to determine how far they can go in order to measure the heart~     function related to exercise.~      The purpose of this study is to measure internal heart pressures using a device called~     Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart~     pressures are measured during invasive (meaning that doctors have to go inside the body~     using a needle or surgery) heart procedures. The NICOM device is non-invasive which means~     the investigators do not have to go inside the body to obtain the heart pressure~     measurements. In this study, the investigators will evaluate the non-invasive measurements~     provided by the NICOM device during the exercise test and see how it relates to information~     from some of subjects' past heart procedures. This research is being done to devise better,~     less invasive ways to assess disease severity, track disease progression and evaluate~     response to therapy.~      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart~     pressures. This device is usually used when a patient can't undergo a right heart~     catheterization. In this study, the investigators are using the device to gather heart~     pressure measurements for research during the exercise test that is scheduled as part of the~     subjects' normal, routine care. The research data is being used to devise better, less~     invasive ways to assess disease severity, track disease progression and evaluate response to~     therapy. The NICOM device is made by Cheetah Medical.~   "
135931|NCT01275690|"~     Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their~     doctors have referred them for a right heart catheterization (RHC). Heart catheterization~     involves inserting an IV (a needle with a small tube) into a vein in the neck. A long,~     narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to~     the heart (sometimes this procedure can be done through a vein in the groin instead). Once~     the catheter is in place, small instruments can be inserted into the catheter to measure the~     pressures in different areas of the heart. These measurements can help the doctor diagnose~     possible problems with the heart functioning.~      The purpose of this study is to evaluate the measurements provided by a device, called~     Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means~     the investigators do not have to go inside the body to obtain the heart pressure~     measurements. While the device has been approved for use in any patient, it remains possible~     that patients with PH will have differences in the way the device calculates measurements.~     In this study, the investigators will compare the in-the-body (right heart catheterization)~     measurements to the non-invasive, outside-body measurements provided by the NICOM device to~     evaluate any differences.~      The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart~     pressures. This device is usually used when a patient can't undergo a right heart~     catheterization. In this study, the investigators are using the device to gather heart~     pressure measurements for research during the right heart catheterization procedure that is~     scheduled as part of the patients' normal, routine care. The research data is being used to~     devise better, less invasive ways to assess disease severity, track disease progression and~     evaluate response to therapy. The NICOM device is made by Cheetah Medical.~   "
135932|NCT01275677|"~     This randomized phase III clinical trial studies chemotherapy with or without trastuzumab~     after surgery to see how well they work in treating women with invasive breast cancer. Drugs~     used in chemotherapy work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery~     may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet~     known whether combination chemotherapy is more effective with trastuzumab in treating breast~     cancer.~   "
135933|NCT01275664|"~     This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in~     preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III,~     or stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen~     or prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III,~     or stage IV ovarian cancer.~   "
135934|NCT01275651|"~     This research trial studies biomarkers in bone marrow and blood samples from patients with~     prostate cancer treated with ketoconazole. Studying samples of bone marrow and blood from~     patients with prostate cancer in the laboratory may help doctors learn more about changes~     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.~   "
135935|NCT01275638|"~     Despite the new developments in sepsis treatment, mortality rate is still high. Discussions~     on steroid treatment in sepsis are going on. In this study, we aimed to investigate the~     effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis~     on prognosis in patients with sepsis.~   "
135936|NCT01275625|"~     One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine~     and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the~     efficacy and safety of this combination in a Russian population of patients.~   "
135937|NCT01275612|"~     This is a pilot, explorative, study to test the feasibility and safety of systemic infusion~     of donor ex-vivo expanded Mesenchymal Stem Cells to repair the kidney and improve function~     in patients with solid organ cancers who develop acute renal failure after chemotherapy with~     cisplatin.~   "
135938|NCT01275599|"~     The purpose of this study is to investigate the drug-drug interaction potential between~     telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will~     help to determine whether buprenorphine dose adjustments are necessary for patients who are~     concomitantly treated with telaprevir.~      Telaprevir, in combination with other antiviral agents, is being investigated for the~     treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for~     maintainance therapy in patients with opioid dependence.~   "
135942|NCT01275547|"~     Introduction~      Ketamine is an old and generally well accepted analgesic used in the intra- and~     perioperative setting. Several studies demonstrated the effectiveness of ketamine in the~     postoperative setting.~      A new formulation of S-ketamine as an intranasal spray device was tested in our hospital in~     8 healthy volunteers (unpublished data, EKBB 351/08). 20 mg of S-ketamine were administered~     intranasally and compared with S-ketamine i.v. and i.m.. None of the volunteers had serious~     adverse effects or complications. A preliminary data analysis shows a clear analgesic effect~     and good absorption of the intranasal S-ketamine.~      As a next step we would like to investigate the effect of S-ketamine intranasal spray~     combined with midazolam intranasal spray in a group of postoperative spinal surgery~     patients. The rational for the combination of intranasal S-ketamine and midazolam is the~     well known midazolam antagonising effect of ketamine induced psychomimetic adverse effects.~     Furthermore we know from other studies (EKBB 106/06) that midazolam intranasal spray has~     relaxant and anxiolytic effects. As far as we know, this is the first study which will~     examine the combination of S-ketamine and midazolam intranasal sprays in adult patients.~      Study work plan~      This prospective, randomized, double-blinded non inferiority study will address pain ratings~     and patient satisfaction in a postoperative setting in two treatment scenarios:~        1. Alternating S-ketamine intranasal unit-dose spray (6 mg per dose) with midazolam~          intranasal spray (0.75 mg per dose) patient controlled application with a lock-out~          interval of 20 minutes between two applications and placebo patient controlled~          analgesia (PCA) with a lock-out interval of 12 minutes with saline 0.9% i.v. for 72~          hours or until 40 unit-dose sprays are delivered~        2. PCA with 2 mg morphine with a lock-out interval of 12 minutes i.v. with placebo~          intranasal spray (saline 0.9% + chitosan) with a minimum lock-out interval of 20~          minutes for 72 hours or until 40 unit-dose sprays are delivered~      Patient number~      We will examine 36 patients, 18 patients in each group. The study duration for an individual~     patient will be at latest 72 hours, the total study duration is 4 to 5 months.~      Study importance~      An intranasal spray is an ideal application form for surgery patients, either in- or~     outpatients. On the other hand, ketamine and S-ketamine is quite often used in the~     perioperative setting as a rescue analgesic. In higher doses it could be used as an~     emergency tool in emergency prehospital medicine. In the perioperative setting it is~     important to evaluate the efficacy and safety of S-ketamine intranasal spray combined with~     midazolam intranasal spray in patients.~      If our study shows that S-ketamine intranasal spray is effective as an analgesic and has~     good patient acceptance, S-ketamine intranasal spay could be considered as an alternative,~     completely non-invasive analgesic procedure in a postoperative outpatient setting. As a~     consequence development of a nasal multidose-applicator combining S-ketamine and midazolam~     would be of interest.~   "
135943|NCT01275534|"~     In the study PROVIVO, a patient reported outcome instrument consisting of items from the~     PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic~     hematopoietic stem cell transplantation (SCT) will be developed. The instrument development~     is based on cognitive patient interviews, a survey of hematology experts and a literature~     review. In a subsequent cross-sectional study phase, the instrument will be validated in a~     sample of 300 allogeneic stem cell recipients and by the use of additional self report~     instruments it will be possible to explore how subjective symptom experience, problems in~     self-management and presence of late effects are connected.~   "
135944|NCT01275521|"~     BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the~     prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that~     are not fully elucidated. It is the same for symptomatology and urodynamic obstruction~     without clear identification of the part which is due to static phenomena (volume increase)~     and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and~     the difficulty of therapeutic indications between monitoring, medical treatment, and~     surgical operation. Experimental studies of BONT-A intra prostatic injection on animal and~     human models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline~     in the number of adrenergic α1 receptors.~      Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini~     invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.~      PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique~     BONT-A injection in the treatment of symptomatic BPH.~   "
135945|NCT01275508|"~     The scientific objective of the project is to evaluate if the topical administration of~     Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the~     gut in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective~     is to explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably~     predict patient response to Adalimumab therapy and hence enable optimized utilization of~     this treatment option.~   "
135946|NCT01275495|"~     The purpose of this study is to test the efficacy of the revised Telephone Assessment and~     Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR)~     intervention in family caregivers of stroke survivors. We will also test if TASK II~     intervention effects on primary outcomes (depressive symptoms, caregiving-related negative~     life changes, unhealthy days) are mediated through effects on secondary outcomes (task~     difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and~     ISR interventions will also be explored.~   "
135947|NCT01275482|"~     The purpose of this study is to determine whether Transverse Friction Massage (TFM) in~     Latent Myofascial Trigger points (MTrP) is more effective making this technique in two~     different ways.~   "
135948|NCT01275469|"~     The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo~     in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance~     and abdominal obesity, and to assess the tolerability and safety of once-a-day~     administrations of oral doses of GFT505 during 35 days.~   "
135949|NCT01275456|"~     This clinical validation study is aimed at testing the efficacy of a new environmental~     challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to~     house dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal~     Symptom Score (TNSS), allowing for determine whether the challenge is dose dependent and~     reproducible.~   "
135950|NCT01275443|"~     TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278~     is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been~     developed so the drug stays in the bloodstream for a longer time - this allows the drug to~     be given by injection and less often. It is hoped that this injectable version of the drug~     may be used to help prevent HIV transmission in the future by giving it to people who are at~     risk of HIV. This is similar to the way travellers to areas with malaria may take~     antibiotics to prevent infection. The investigators aim to investigate the feasibility of~     using TMC278 as a preventative medication by performing this study.~      The purpose of this study is to investigate the levels of drug which can be measured in the~     blood, as well as the tissues and fluids of the rectum (the lowest part of the bowels just~     before the opening of the anus) as well as the safety of the drug and how well tolerated it~     is when given as a single dose. In this study, the investigators will not be investigating~     whether the drug prevents HIV so the investigators will recruit people who are HIV negative,~     and whose lifestyle does not put them at risk of becoming infected before or during the~     study.~      If the study shows the drug is well tolerated and produces appropriate levels of the drug~     (in the bloodstream and the rectal compartment) to suggest that it could be effective, it~     will help design future studies looking at preventing HIV.~   "
135963|NCT01275274|"~     The purpose of this research study is to learn if adding all-trans retinoic acid (tretinoin)~     to conventional treatment of Anti- Neutrophil Cytoplasmic Autoantibodies (ANCA) vasculitis~     can decrease the level of disease activity.~   "
135953|NCT01275404|"~     The investigators know that treatment for prostate cancer and erectile dysfunction can~     impact sexual health and quality of life. They want to learn how the treatment affects one's~     emotional and social well-being.~      They have developed a new type of counseling. Cancer patients seek counseling for lots of~     reasons. It often helps them cope because they can express their feelings with a trained~     professional. They hope that this counseling will teach patients skills that they can use to~     comply with erectile treatment programs, improve their sexual health and quality of life.~     These skills may also improve physical and emotional well-being. As part of this study they~     will ask the patient to provide feedback on the proposed counseling.~   "
135954|NCT01275391|"~     In this project we will conduct a pilot study of a brief intervention to reduce teen~     tobacco, alcohol and drug use that primary care dental practitioners can provide in their~     offices.~   "
135955|NCT01275378|"~     The purpose of this study is to compare the effectiveness of two care models on ADHD~     outcomes: one, a model of basic care management and structured communication with~     specialists, consistent with conventional descriptions of a patient-centered Medical Home;~     and another, which combines the Medical Home with theory-based care management strategies to~     address common reasons for ADHD treatment failure.~   "
135956|NCT01275365|"~     This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial~     in community dwelling, older men, 65 years of age or older, who have mobility limitation and~     low protein intake. The study will have a 2 X 2 factorial design, which will allow us to~     investigate the effects of dietary protein intake and testosterone separately and together.~   "
135957|NCT01275352|"~     This study will consist of middle-aged Caucasian non-failing subjects with high blood~     pressure who are homozygous for a gene that confers increased risk of developing heart~     failure, the Glycine 83 variant of the Ka renal chloride channel (ClC-Ka Gly/Gly 83), or~     middle-aged Caucasian non-failing hypertensive subjects who lack the heart failure risk~     gene, the wild-type Arginine 83 Ka renal chloride channel (ClC-Ka Arg/Arg 83). Subjects on~     standard therapy for high blood pressure with an angiotensin converting inhibitor (ACEI) or~     angiotensin receptor blocker (ARB) will be randomized to additional treatment with~     eplerenone (an aldosterone antagonist) or placebo, and assessed for changes in~     echocardiographic left ventricular hypertrophy (LVMI). Secondary endpoints will assess left~     ventricular remodeling and other echocardiographic variables. The investigators hypothesize~     that subjects homozygous for the CLCNKA risk allele will have a greater response to~     eplerenone in terms of reductions in LVMI than those lacking the risk allele.~   "
135958|NCT01275339|"~     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy~     available to improve any clinical outcomes, including symptoms, time to surgery, or~     long-term survival. Thus far, randomized studies involving statins have not been promising~     with respect to slowing progressive valve stenosis. Beyond the valve, two common~     consequences of aortic stenosis are hypertrophic remodeling of the left ventricle (LV) and~     pulmonary venous hypertension; each of these has been associated with worse heart failure~     symptoms, increased operative mortality, and worse long-term outcomes. Whether altering LV~     structural abnormalities, improving LV function, and/or reducing pulmonary artery pressures~     with medical therapy would improve clinical outcomes in patients with AS has not been~     tested. Animal models of pressure overload have demonstrated that phosphodiesterase type 5~     (PDE5) inhibition influences nitric oxide (NO) - cyclic guanosine monophosphate (cGMP)~     signaling in the LV and favorably impacts LV structure and function, but this has not been~     tested in humans with AS. Studies in humans with left-sided heart failure and pulmonary~     venous hypertension have shown that PDE5 inhibition improves functional capacity and quality~     of life, but patients with AS were not included in those studies. The investigators~     hypothesize that PDE5 inhibition with tadalafil will have a favorable impact on LV structure~     and function as well as pulmonary artery pressures. In this pilot study, the investigators~     anticipate that short-term administration of tadalafil to patients with AS will be safe and~     well-tolerated.~   "
135959|NCT01275326|"~     Outbreaks of emerging and re-remerging infectious diseases are frequently reported~     internationally in recent years, mainly due to global climate change, close human-livestock~     contact in developing countries, and globalization. Thus prevention, monitoring and control~     of infectious diseases are in urgent need to protect public health. High exposure risk to~     various infectious agents in health care facilities is of special concern, especially to~     airborne and droplet-borne respiratory diseases. To protect the health of public and health~     care workers the investigators will conduct a study to monitor indoor air quality and~     essential infectious aerosols in hospital(s).~      A questionnaire survey will be used to evaluate the relationships between employees' health~     and measured indoor environmental factors. The investigators will also examine whether the~     current indoor air quality recommendation of their country can reasonably reduce the risk of~     hospital infection. In addition, simple infectious aerosol indices will be established for~     future environmental management and monitoring in health care facilities.~   "
135960|NCT01275313|"~     The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in~     preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they~     are common in nursing home settings because their causes are difficult to identify. This~     clinical trial will guide practitioners toward improving preventive care practices by~     demonstrating how to effectively apply wheelchair and seat cushion technology.~   "
135961|NCT01275300|"~     We would like to see if aspirin could block niacin-induced flushing by analyzing blood and~     urine after taking aspirin.~      Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin, 2 week washout and 5~     days taking the alternate. The order in which this is given will be randomized or assigned~     by chance.~      Phase II: One study week consisting of 5 days of taking 81 mg Aspirin, taken once daily,~     followed by a single dose of 600 mg Niacin on day 6.~      Phase III: 5 days taking 81 mg Aspirin/placebo, 10 day washout in between.~      Phase IV: Use of extended release niacin instead of instant release.~      Phase V: A Celebrex study is necessary to explore the contribution of Cox-2 to niacin~     induced flushing.~   "
135962|NCT01275287|"~     The purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in~     addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic~     Autoantibodies ) vasculitis and lead to a more rapid decrease in disease activity.~      ANCA vasculitis is an inflammation of the small vessels whereby ANCA antibodies~     inappropriately activate one's own white blood cells (neutrophils) and cause damage to the~     small blood vessels.~   "
135964|NCT01275261|"~     The purpose of this study is to determine whether bladder catheterization can be safely~     avoided in patients admitted to the hospital with stroke using a nursing protocol, and~     whether this decreases the incidence of urinary tract infections. The investigators~     hypothesize that the protocol will be tolerated by nurses and patients, and that patients~     without bladder catheters will have fewer urinary tract infections and better outcomes.~   "
135965|NCT01275248|"~     This study is to assess the efficacy and safety of two doses of ondansetron (0.5 mg and 0.75~     mg) relative to placebo when administered twice daily as adjunctive therapy for adult~     patients with Obsessive-Compulsive Disorder (OCD) who have not adequately responded to~     treatment with a serotonin reuptake inhibitor (SRI).~   "
135966|NCT01275235|"~     Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at~     greater risk for the disease, and studies have shown that how the body responds to insulin,~     how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often~     different in these individuals at a young age compared to people without a family history of~     the disease. The tendency to develop T2DM is influenced strongly by genetics; however,~     exposure to the surrounding environment may also play a role. The exposure to a diabetic~     environment while in the womb represents an altered nutritional exposure (high levels of~     circulating sugar, or glucose) that may affect how tissues important in regulating energy~     metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this~     study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen~     and skeletal muscle function in young adult sibling pairs who were raised together but who~     are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes~     during pregnancy with the older sibling, but did have diabetes during pregnancy with the~     younger sibling).~   "
135967|NCT01275222|"~     This trial was a Phase I/II, non-randomized, open label, multi-center study, following a~     sequential 2- part design. The first part, Phase I, was designed to assess whether there is~     a pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as~     well as to collect safety data when these two drugs are co-administered. The second part,~     (Phase II), was designed to assess the potential efficacy of the combination in~     imatinib-resistant GIST patients in two strata of patients:~        -  Patients resistant to imatinib as first-line drug therapy and in whom the maximum~          tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory)~        -  Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2,~          post second-line therapy).~   "
135968|NCT01275209|"~     This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with~     bendamustine in patients with follicular lymphoma.~   "
135969|NCT01275196|"~     The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly~     diagnosed Chinese patients with CML-CP.~   "
135970|NCT01275183|"~     The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase~     inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial~     tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and~     after cisplatin-raltegravir. The investigators will investigate immunohistochemical~     expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and~     apoptosis. The study is designed to identify an intermediate signal of the potentiation of~     cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II~     study.~   "
135971|NCT01275170|"~     Part I of this study will compare the pharmacokinetics of MK-7655, dosed in combination with~     PRIMAXIN® (imipenem + cilastatin), in participants with impaired renal function and matched~     control participants. In Part II of the study, the potential for renal insufficiency to~     affect non-renal clearance mechanisms will be investigated.~   "
135972|NCT01275157|"~     This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to~     study the absorption, distribution, metabolism, and elimination of LY2452473.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
135973|NCT01275144|"~     The purpose of this study is to determine how much lorazepam gets into the blood and how~     long it takes the body to get rid of it when given together with LY2216684. Information~     about any side effects that may occur will also be collected.~   "
135974|NCT01275131|"~     The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20)~     will change the exposure and action of approved insulin analogs when given by continuous~     subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).~      This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before~     Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage~     2. Stage 2 was not initiated due to a strategic business decision and termination was not~     based on safety or efficacy concerns. No participants were enrolled in Stage 2.~   "
135975|NCT01275118|"~     Comparison of postoperative visual acuity and spectacle independence between the Tecnis~     Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL~   "
135976|NCT01275105|"~     The purpose of this study is to evaluate the safety, efficacy, and dose response of~     brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of~     allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.~      It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more~     effective than vehicle in the prevention of conjunctival redness induced by conjunctival~     allergen challenge when instilled prior to the allergen challenge.~   "
135977|NCT01275092|"~     The objective of this study is to evaluate the safety and effectiveness of the clinical and~     technical performance of the CorPath® 200 System in the delivery and manipulation of~     coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions~     (PCI).~   "
135978|NCT01275079|"~     The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai~     adults.~   "
135991|NCT01274910|"~     This is a single-center, prospective, randomized, double blind, placebo control study. The~     aim of this study is to assess the effect of fish oil capsules on pain intensity and~     postoperative analgesics consumption in patients after knee replacement surgery.~      The study population will be adult are referred for knee replacement surgery due to~     osteoarthritis of the knee.~   "
135992|NCT01274897|"~     This study is designed to evaluate the immunogenicity and the safety of a quadrivalent~     vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.~   "
135979|NCT01275066|"~     This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0~     mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A~     Syndrome).~      There is currently no standard accepted treatment for MPS IVA other than supportive care.~     Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA~     patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular~     uptake by the mannose-6-phosphate receptor and transportation to the lysosomes.~      This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of~     keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and~     heart valve, and reduce the progressive accumulation of KS which is responsible for the~     clinical manifestations of the disorders.~   "
135980|NCT01275053|"~     The purpose of this research study is to help us to better understand how leptin regulates~     blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells.~     Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and~     influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an~     investigational drug and has not yet been approved by the Food and Drug Administration~     (FDA), will be administered to participants in this study. The expected duration of your~     participation is 3 study visits, which will be spread over 3-4 weeks.~      This study involves having fat and muscle biopsies after receiving leptin under local~     anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or~     Endocrinology exam room at the Beth Israel Deaconess Medical Center.~   "
135981|NCT01275040|"~     A pragmatic cluster randomised controlled trial will be done where the intervention will be~     a mobile screening team visiting selected PHC facilities in Tshwane district. It will~     provide education and screening for diabetic complications (foot, kidney, cardiac and~     retinal complications). Six clinics will receive the intervention and six clinics will serve~     as controls. Six hundred patients will be recruited (2 x 300).~      The screening results will be evaluated by an expert panel at tertiary care level and an~     individualised patient management plan will be compiled. This plan will be communicated to~     the family physician and integration team at the clinic for further management or referral~     of the patients. Laser therapy will be available on the mobile clinic for patients that~     require it (as assessed by an Ophthalmologist who will review the retinal photos).~      A baseline evaluation (including HbA1c, serum creatinine, lipogram and urine~     albumin-creatinine ratio) will be done to determine current disease management at patient~     and health facility level, followed by the intervention and a follow-up visit a year later.~     The main outcome measures are glucose, lipid and blood pressure control as well as the~     percentage of patients screened and referred for diabetes complications.~      A cost effectiveness analysis will be done to estimate the added cost per added complication~     prevented or referred.~      The potential implications for improving diabetes care and preventing long term~     complications are extremely important. The study results will be used to help plan future~     health care services for people with diabetes mellitus in the region.~   "
135982|NCT01275027|"~     The purpose of this clinical research study is to evaluate the effects an investigational~     food product has on the blood sugar and insulin levels in individuals with diabetes.~   "
135983|NCT01275014|"~     The aim is to compare the effectiveness of corticosteroid administration (dexamethasone)~     with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ).~     Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly~     assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis~     procedure is carried out, while a single dose intraarticular dexamethasone was delivered to~     participants in one arm. Saline was delivered in the other arm to serve as a control. Follow~     up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm~     VAS) and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations~     (GEE) are used for statistical analysis.~   "
135984|NCT01275001|"~     The purpose of this research study is to learn more about the effects a musical intervention~     has on typical brain development in preschool-aged children.~   "
135985|NCT01274988|"~     Nucleus accumbens plays important roles in the process of opiate addiction and initial of~     relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its~     activity and thus to effectively prevent the relapse of the opiate dependence.~   "
135986|NCT01274975|"~     This study is designed to assess the safety of intravenous autologous adipose derived~     mesenchymal stem cells transplant in spinal cord injury patients.~   "
135987|NCT01274962|"~     This study is proposed to evaluate whether giving part of the chemotherapy prior to~     radiotherapy and surgery (as opposed to standard of care, which involves giving all the~     chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal~     cancer will result in higher patient compliance to chemotherapy.~   "
135988|NCT01274949|"~     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED~     patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to~     affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor~     therapy.~   "
135989|NCT01274936|"~     Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal~     distribution. Cervical radiculopathy results from impingement on a nerve root by either~     spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation.~     Specifically, it should be the goal of the treating physician to relieve pain, improve~     function, and prevent recurrence. Various studies have shown that nonoperative management of~     cervical radiculopathy leaves a substantial minority of patients with persistently~     troublesome symptoms. Pharmacologic agents treat the underlying condition and provide~     symptomatic relief. The various classes of medications used to treat radiculopathy include~     steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and~     antidepressants. Herbal medicines have been used for centuries in China. In China, many~     patients with cervical disc disease are increasingly turning to herbal medicines to~     alleviate their symptoms and reduce the side effects of medications. The goal of this study~     is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat~     cervical radiculopathy.~   "
135990|NCT01274923|"~     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on~     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.~   "
135998|NCT01274819|"~     Rationale: Delirium is a frequently encountered problem in ICU patients and leads to~     increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation~     which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims~     at restoring a proper circadian rhythm by rhythmically alternating light intensity and has~     shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces~     delirium incidence in ICU patients is not known~      Goals/endpoints:~      To evaluate the feasibility of dynamic light application in the ICU and to study the effects~     of dynamic light application on the incidence of delirium, duration of mechanical~     ventilation, the number of ICU and hospital days, and mortality in a mixed population of~     medical and surgical ICU patients. In a subgroup of patients with a high risk of developing~     delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will~     be assessed Study design: prospective randomized single centre trial Study population: adult~     ICU patients > 18 years old with an expected duration of stay of more than 24 hours~     Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When~     receiving standard care, normal lighting settings will be used in that patient room, which~     can be controlled by the medical personnel; In the rooms of patients randomized to the DLA~     group, DL is applied with a changing intensity during the day according to a fixed rhythm,~     which is regulated centrally. In addition when necessary, an intervention light can be used~     which can be operated in the patient room.~      Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of~     mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels~     of inflammatory markers and markers of brain damage, urinary levels of markers of circadian~     rhythm, data of HRQoL questionnaires and total light exposure in both groups~   "
135999|NCT01274806|"~     Effectiveness of a physical therapy program focussed on core stability exercise and massage~     as a recovery method in breast cancer survivors after oncology treatment.~   "
136000|NCT01274793|"~     the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture~     with Two-ways Regulation Effect to Treat Functional Enteropathy~   "
136001|NCT01274780|"~     This is a prospective, open controlled trial in which naïve HIV-1 patients will be~     randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with~     tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the~     cholesterol levels.~      Randomization will be stratified according to the values of the ratio of total~     cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥~     4.5).~   "
136002|NCT01274767|"~     Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and~     stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence~     indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events~     and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of~     bleeding is low, aspirin users who do not have previous ulcer disease do not require~     prophylaxis with anti-ulcer drugs. In contrast, aspirin users with a history of ulcer~     disease have a 2- to 4-fold increased risk of ulcer bleeding. The best strategy for reducing~     the risk of bleeding in high-risk aspirin users remains unclear. Current strategies for~     high-risk patients include the use of anti-ulcer drugs, elimination of risk factors (e.g.~     Helicobacter pylori), or the use of enteric-coated aspirin.~      Although co-therapy of aspirin with an acid suppressant reduces the risk of ulcer bleeding,~     drug compliance may limit its clinical usefulness particularly in patients who are already~     receiving multiple drugs. The efficacy of enteric-coated aspirin in preventing ulcer~     complications showed conflicting results. One study found that enteric-coated aspirin~     increases the risk of ulcer bleeding. A recent study showed that enteric-coated aspirin~     causes minimal acute gastric injury.~      The investigators postulated that among patients without H. pylori infection and a history~     of ulcer bleeding who continue to use low-dose aspirin, enteric-coated aspirin reduces the~     long-term risk of ulcer complications to a level that is comparable to that of average-risk~     aspirin users.~   "
136003|NCT01274754|"~     Neurological complications occur in open heart surgery with a frequency of 40% and they~     range from major neurological deficits (due to a stroke) to neurocognitive and behavioral~     disorders. This study aims to determine if erythromycin, a worldwide known antibiotic,~     protects the brain from damage when given in high doses before and during open heart~     surgery.~      The investigators consume that high dose of erythromycin will protect the brain with a~     pharmacological preconditioning against the global ischemia during the perioperative period~     of heart surgery.~   "
136004|NCT01274741|"~     The purpose of this study is to determine if an integrated, cognitive-behavioral model of~     psychotherapy is effective in the treatment of individuals with posttraumatic stress~     disorder (PTSD) and substance use disorder (SUD) compared to a known evidence-based model~     for PTSD/SUD.~   "
136005|NCT01274728|"~     This clinical evaluation will study the feasibility and safety of a CE-marked~     paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons~     provide the potential advantage of delivering a anti-proliferative drug, without the~     disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.~   "
136006|NCT01274715|"~     The purpose of this study is to determine if behavioral health coaching for rural veterans~     with diabetes and depression will improve self-management behaviors and lead to improvement~     in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.~   "
136007|NCT01274702|"~     Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution~     therapy is a software-based approach that has been shown to substantially improve residual~     visual field deficits in patients with pre- and postchiasmatic lesions.~      The primary hypothesis of this randomized, controlled clinical trial is, that visual~     reconstitution therapy is superior to active comparator treatment in improving the visual~     field after optic neuritis.~   "
136008|NCT01274689|"~     The note re-introduces the external lid loading with the help of a lead weight for the~     temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely~     used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight~     (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous~     ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is~     possible. The effect is gravity dependent, so that the patient has to wear the monoculus at~     night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In~     case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow.~     A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the~     lid immediately. Almost half of the patients had to re-adjust the weight several times per~     day due to hooded eyelids. The compliance was high, and a partial or complete restoration of~     the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the~     restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The~     external lid loading for the temporary treatment of lagophthalmos is simple and effective.~     Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for~     most patients. The faster restoration of the M. orbicularis oculi hints at a potentially~     facilitatory effect of the weight.~   "
136009|NCT01274676|"~     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The~     intra and/or postprocedural cerebral embolization remains the most frequent complication.~     Thanks to the systematic use of cerebral protection systems, these complications have~     reduced.A debate concerning which cerebral protective device should be more effective is~     still ongoing.~   "
136010|NCT01274663|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.~   "
136011|NCT01274650|"~     Patient nutritional needs vary depending on several factors including age, sex, height,~     weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this~     must be taken into account when assessing nutritional requirements. Indirect calorimetry~     will be used to measure energy expenditure of patients with decubitus ulcers of varying~     degrees. The primary objective of this study is to determine the effects of wound volume on~     metabolic rate and compare this to predictive equations used for estimating energy~     requirements.~   "
136012|NCT01274637|"~     The purpose of this study is to determine if it is feasible to conduct a multi-center~     randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH),~     is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.~   "
136013|NCT01274624|"~     This is a Phase 1 dose-escalation study with three dose levels to determine the maximum~     tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.~   "
136014|NCT01274611|"~     The purpose of this study is to compare the effectiveness of two methods in the treatment of~     excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox~     injections. Suction-curettage is a method in which the doctor will insert a suction tool~     into two small incisions in order to suction out the sweat-producing glands. It is similar~     to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the~     deep skin where the sweat glands are located. This method has been shown in some studies to~     effectively reduce underarm sweating for months at a time. Botox is a Food and Drug~     Administration (FDA) approved drug that in small doses, paralyses muscles. It is most~     commonly and famously used in the treatment of facial wrinkles. However, it has also been~     approved to treat excessive sweating. When injected in areas that sweat excessively,~     sweating can be significantly reduced in that area for months at a time. This study is a~     pilot study designed to determine feasibility of these procedures.~   "
136015|NCT01274598|"~     This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus~     rhamnosus GG (LGG) in elderly subjects. Lactobacilli are part of the normal flora of the~     intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or~     microorganism administered to confer health benefits. Our research is focused on studying~     the possible therapeutic effects of LGG. The study hypotheses are:~        -  LGG administered twice daily will be safe and well tolerated in elderly subjects~        -  LGG will colonize the stool of elderly subjects and will modify the diversity and~          richness of the microbiota in their nasopharyngeal and stool specimens~   "
136016|NCT01274585|"~     The primary objective of this study is to determine whether Percutaneous Tibial Nerve~     Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment~     of patients with urinary incontinence, can also be used to treat fecal incontinence.~     Specifically, the primary endpoint of this study is to determine, in a randomized controlled~     patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in~     the patients treated with PTNS when compared to placebo as documented by a 2 week patient~     bowel diary after treatment.~      The investigators secondary endpoints will consist of measurements of the impact of PTNS on~     the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity~     Index (FISI) score ), as well as on the patient quality of life factors related to fecal~     incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL)~     scale).~   "
136017|NCT01274572|"~     This study is being conducted to assess and monitor immune response in patients with~     minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be~     receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment~     regimen.~   "
136018|NCT01274559|"~     This is a multicenter, randomized, double-blind, placebo-controlled study in participants~     with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density~     lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER)~     niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying~     therapy (LMT): simvastatin,~      atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC),~     or any statin co-administered with ezetimibe. The study is based on the hypothesis that~     ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.~   "
136019|NCT01274546|"~     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes~     data on patients who received the cruciate-retaining Foundation Knee system during or prior~     to the year 2000.~   "
136020|NCT01274533|"~     This is a research study for subjects who have been diagnosed with Adult T cell~     Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus~     HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of~     this research study is to evaluate the use of the investigational drug lenalidomide in the~     treatment of Adult T cell Leukemia/Lymphoma.~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, in theory, it~     may reduce or prevent the growth of cancer cells.~      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of~     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for~     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM~     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In~     this case it is considered experimental.~   "
136042|NCT01274247|"~     Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg~     maternal nipple pain and infant's latching difficulties. The procedure carries minor~     discomfort for the infants. It is not known whether the use of topical benzocaine, a very~     bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will~     measure the duration of crying in infants treated with topical benzocaine to the duration in~     those not treated with the mediation.~   "
136021|NCT01274520|"~     This is a study comparing a technique of continuous circulation to the liver as a means of~     preventing liver damage during transportation to the transplant hospital. This new technique~     of Machine Perfusion (MP) will be compared to the standard technique where the liver is~     maintained in a bag of solution on ice without circulation. The investigators will evaluate~     and compare the outcomes of the transplants with the new technique to the standard~     technique. There will be 24 MP patient's in the study. The investigators have previously~     used this technique with success in 20 human liver transplant patients. The investigators~     think there will be a benefit in terms of less damage to and better function of the donor~     liver which will result in faster recovery for the patients. This protective effect may~     allow us to successfully transplant more patients and prevent people from dying while~     waiting for a liver transplant.~   "
136022|NCT01274507|"~     The purpose of this study is to characterize the clinical, physiologic, and molecular~     profiles of healthy participants, participants with mild, moderate, and severe asthma; and~     participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).~   "
136023|NCT01274494|"~     The aim of this multi-centre survey is to assess treatment adherence and quality of life in~     a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled~     essential hypertension being on antihypertensive treatment for at least 6 months.~   "
136024|NCT01274481|"~     This study will examine the hypothesis that iloprost maintains and improves ventilation~     perfusion matching in patients with pulmonary hypertension and ARDS/ALI as reflected by 1)~     an improved PaO2/FIO2 ratio as calculated from the measured arterial blood gases obtained~     before and after iloprost administration, 2) an improvement in lung compliance, and 3) an~     improvement in the ventilatory equivalents for oxygen and CO2 measured by expired gas~     analysis.~   "
136025|NCT01274468|"~     The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy~     specimens and bronchial washings from patients with lung cancer.~   "
136026|NCT01274455|"~     Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced~     and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine)~     is given as a palliative therapy. Aim of the present study is to evaluate the feasibility,~     tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product~     (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with~     unresectable pancreatic carcinoma.~   "
136027|NCT01274442|"~     Patients that may participate in this case-control study underwent dental implant surgery in~     the University Hospital in Ghent in 2004-2007.~      According to one of our recent papers based on this patient group, 34/461 patients lost one~     or more implants. The goal is to invite these 34 patients, to update the anamnesis, to~     perform a brief clinical oral examination and to have a blood sample. The latter is~     necessary to identify relevant genetic polymorphisms of the patient that are associated with~     implant loss. Among the remaining patients that did not lose implants, another 34 'controls'~     will be invited for the same examinations.~   "
136028|NCT01274429|"~     The goal of this study is to produce a new treatment that would benefit adult subjects by~     lowering the risk of anaphylactic reactions (desensitization), and changing the~     peanut-specific immune response in subjects who have peanut allergy (tolerance). This~     project is designed to study the innovative idea that oral immunotherapy (OIT), the~     ingestion of small increasing amounts of food allergen, will desensitize subjects with~     peanut hypersensitivity by regulating their mucosal and systemic immune reactivity and cause~     long-term tolerance.~   "
136029|NCT01274416|"~     The investigators are trying to learn the most effective way to treat an adolescent's eating~     disorder and how best to involve the parents or caregivers in this process.~      Typically, parents and their child are seen together in therapy. However, this can sometimes~     be difficult for both the parents and the adolescent. Both parents and adolescents have~     different concerns and are struggling with different aspects of the eating disorder.~     Therefore, the treatment in this study involves the parents in treatment, but does not have~     therapy sessions with the parents and child together.~      The purpose of this study is to develop this investigational type of treatment (separated~     family treatment), and see what works best for adolescents and their families.~      Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the~     first 16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet~     with the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents~     and parents will meet with the therapist together. This is to help parents and adolescents~     come together as a family to continue to aid the adolescent in the treatment of his/her~     eating disorder.~      The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement~     in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT~     will demonstrate decreased distress and caregiver burden, that increases in psychological~     acceptance will be seen for both adolescents and caregivers post-treatment, and that~     treatment will be viewed as both credible and acceptable to both caregiver and adolescent~   "
136030|NCT01274403|"~     The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus~     meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients~     with multiple myeloma but not eligible for high dose treatment with stem cells support.~   "
136031|NCT01274390|"~     This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage~     Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS~     study randomizes cardiac surgery patients to receive either red blood cell units stored for~     no more than 10 days, or red blood cell units stored for at least 21 days, if they need any~     red blood cell transfusions during their hospital stay for the surgery.~      This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures:~     RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there~     will be differences between the two randomized treatment groups in how much the following~     measurements change, from shortly before a red blood cell transfusion to shortly after a red~     blood cell transfusion, and from before surgery to 24 hours after surgery:~        -  Oxygen saturation in the hand~        -  Oxygen saturation in the brain~        -  Blood flow in the small blood vessels under the tongue.~      The RECAP study will also investigate whether changes in the measurements listed above are~     associated with clinical outcomes, including~        -  The Multi-Organ Dysfunction Score~        -  Death from any cause~        -  Major cardiac events~        -  Major pulmonary events~   "
136032|NCT01274377|"~     Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in~     immunocompromised individuals, such as recipients of stem cell transplants, this virus is a~     major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV~     disease, these medications have numerous side effects, the most serious of which is~     myelosuppression. The frequency of neutropenia ranges from 41% to 58% in stem cell~     transplant (SCT) patients treated with ganciclovir. Withdrawal of anti-CMV therapy due to~     these complications may result in recurrent disease. The restoration of cellular immunity to~     CMV is necessary in order to prevent viral reactivation, and the generation of cytotoxic T~     cells against CMV early antigens is perhaps the most important part of the host immune~     response to CMV. At day 40 post-transplant, for example, at least 65% of SCT patients are~     deficient in CD8+ T-cell responses to CMV. Previous studies have demonstrated a direct~     correlation between CMV infection in these patients and cytotoxic T lymphocyte (CTL)~     function, with patients who have defects in cellular immunity being at high risk for~     invasive CMV disease. The median time post-transplant for the development of CMV disease is~     50 to 60 days, and CMV re-activation occurs in 70 to 80% of CMV sero-positive SCT~     recipients. Without anti-viral therapy as many as 50% of these patients will develop CMV~     disease.~   "
136033|NCT01274364|"~     Quality diabetes care requires a team approach and informed decisions of patients and care~     providers. Several lines of evidence suggests that a protocol-driven care model delivered by~     trained staff with focus on periodic assessments, reinforcement of patient compliance and~     attainment of multiple treatment targets reduces risk of cardio-renal complications and~     early death in type 2 diabetes.~      The investigators hypothesize that the use of state of the art information technology to~     record, manage and analyze the large amount of clinical information generated during various~     consultation visits will improve the effectiveness and efficiency in implementing these care~     protocols through decision support and regular feedback to both patients and care team.~   "
136034|NCT01274351|"~     This study is designed to investigate the molecular and cytogenetic effects and safety~     profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk~     groups of patients and to compare patients with high Socal risk score with patients having~     intermediate and low Socal risk score.~   "
136035|NCT01274338|"~     This randomized phase III trial studies ipilimumab to see how well it works compared to~     high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that~     has been removed by surgery. Monoclonal antibodies, such as ipilimumab, may interfere with~     the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the~     growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known~     whether ipilimumab is more effective than interferon alfa-2b in treating patients with~     melanoma.~   "
136036|NCT01274325|"~     The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway~     inflammation in asthmatic patients in the same as Seretide.~   "
136037|NCT01274312|"~     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder~     dysfunction. Recently, the concept of a surgically created somato-sensory reflex arch for~     bladder dysfunction in SCI has been introduced. The concept is promising, not just for~     bladder but also for bowel dysfunction. However, well designed studies need to be performed~     before recommending the procedure to a large number of patients worldwide. In this study the~     investigators perform multidisciplinary studies providing necessary information about the~     clinical outcome of the somato-sensory reflex arch in adult SCI patients.~      The hypothesis is as follows:~        1. Somato-sensory reflex arch increases colorectal transport between defecations~        2. Somato-sensory reflex arch improves colorectal emptying at defecation~   "
136038|NCT01274299|"~     Anthropometric data of infants' face will be obtained using special 3D scanners and~     software.~   "
136039|NCT01274286|"~     Since the first hospital accreditation was implemented in our country in 1978, we have~     become the fifth in the world, the first in Asia that applied the system of hospital~     accreditation. While discussing the development of the hospital accreditation history of~     Taiwan, different concerns have been raised over time.~      The main objective of this study is to scrutinize if there have been any quality improvement~     of healthcare that hospitals delivered since the renewal of hospital accreditation~     standards. Also, in order to provide suggestions to make the hospital accreditation a better~     one, this study firstly endeavors to locate the differences which were brought out by both~     the old and the new hospital accreditation.~      Second, this study will analyze and survey the impacts of accreditation on hospitals'~     performance and healthcare. After finishing the first two steps, this study will then state~     updated improvement suggestions.~      Documentary analysis and meta analysis will be the two major scientific research methods in~     this study. Data will be collected from various resources, such as government agencies,~     private research institution and hospitals around the nation. By collecting raw data broadly~     and deeply, the accountability, therefore, can be ensured.~      Throughout the efforts of identifying differences between the new and old accreditation~     standards, comparing hospitals' scores on performance index and finding evidence of~     performance improvement, we hope this study would provide the most comprehensive and solid~     suggestions to improve our hospital accreditation system.~   "
136040|NCT01274273|"~     The purpose of this study is to determine whether interleukin-2, interferon-alpha in~     combination with bevacizumab are effective in the treatment of metastatic renal cell~     carcinoma (mRCC).~   "
136041|NCT01274260|"~     Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating~     disorders associated with lung inflammation, low oxygen levels and respiratory failure in~     children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these~     estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000~     deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in~     children. In adult patients, use of steroids early in the course of ARDS appears promising.~     There are no published clinical trials examining the use of steroids for the treatment of~     ALI/ARDS in children.~      Hypothesis:~      Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours)~     and longer than 7 days will have improved clinical outcomes as compared to placebo control~     group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly~     increased PaO2/FiO2 ratios.~   "
136043|NCT01274234|"~     All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to~     participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT)~     would be performed between 1 to 5 months at the time of a staged PCI procedure (for~     remaining coronary disease) or as clinically indicated, and then at 9 months. At the time of~     the 9-month restudy (a proper time window for drug eluting stent to develop into restenosis~     should it occur), any new disease detected or restenosis will be treated. The reported~     incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected~     to be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9~     months actually confers better protection to the patients with advanced disease and any~     restenosis can be treated timely. All data on clinical events and progress will be monitored~     and regular follow-ups will be carried out.~   "
136044|NCT01274221|"~     The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo~     in adolescent subjects (13-17 years of age inclusive) with ADHD in the analog classroom~     setting based on the Permanent Product Measure of Performance (PERMP) total score assessed~     across 2, 4, 9, 13, 14, and 15 hours post-dose on the last day of each double-blind~     crossover period.~   "
136045|NCT01274208|"~     Study objectives:~        -  Investigate the anti-HCV response in patients with Gaucher disease(GD)~        -  Define the potential role of high levels of Glucocerebroside in the immune system~      Study hypothesis:~      High levels of Glucocerebroside can be used as a tool in the antiviral treatment of~     hepatitis C by potentiating the immune response of natural killer T cells and dendritic~     cells~   "
136046|NCT01274195|"~     In this study we plan to improve the outcome of hematopoietic stem cell transplantation by~     using optimal busulfan dose through pharmacokinetic study.~   "
136047|NCT01274182|"~     The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in~     patients with severe rheumatoid arthritis.~   "
136048|NCT01274169|"~     to measure kidney function by measuring blood creatinine and to compare it to the measurment~     of GFR by Nanotechnology~   "
136049|NCT01274156|"~     This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on~     patients responding to PDE5i therapy in a sham controlled randomized double blind manner.~   "
136050|NCT01274143|"~     The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is~     designed to determine whether a personalized telephone plus mailed print cancer risk~     assessment and behavior change counseling intervention is more effective than a targeted~     mailed print intervention in promoting risk appropriate screening in individuals with a~     family history of the disease. The project targets people residing in both rural and urban~     areas, allowing an examination of differential intervention effects with regard to place of~     residence.~   "
136051|NCT01274130|"~     This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics~     and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers.~     The investigators will apply ranitidine and verapamil to the drug interaction study of~     metformin.~   "
136052|NCT01274117|"~     Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the~     vein dilated with sufficient blood flow in order to puncture the vein and clear the blood~     from wastes, in patients whose kidneys are destroyed and cannot provide this function. The~     success rate of this procedure varies between 50-80% and depends mainly on the size of the~     vein, with success being higher with larger veins. One of the veins used for an AVF is the~     basilic vein, located at the upper arm. This vein is however deeply located and necessitates~     movement (transposition) during surgery to a less deep and lateral path before it is joined~     to the artery, in order to be used. A single study has shown that surgery performed in two~     parts (one to enlarge the vein and the second one to relocate the enlarged vein under the~     wound, not in a new path) is more successful than doing the procedure altogether.~      The aim of this study is to confirm the findings of the single study mentioned above (one~     versus two stages of basilic vein AVF), with the difference that the vein will be relocated~     outside the main wound, a method that is widely accepted as being better.~   "
136053|NCT01274104|"~     The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain~     or aches that may be caused by taking certain medications for treating high cholesterol.~   "
136054|NCT01274091|"~     Interactions between genes and environment, i.e. our inherited responses to environmental~     changes, may be crucial in the development of the common diseases. The investigators were~     the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala~     polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect~     on seems to depend on intervention and age. In this study the effects of diets high with~     saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects~     carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene.~      Aim of the study:~      To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet~     supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA).~      Hypotheses:~        1. Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary~          modification, and therefore respond more favorably to PUFA diet~        2. More general: Dietary instructions individually tailored according to the genotype~          would allow better treatment of obesity and diabetes~   "
136055|NCT01274078|"~     About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4~     weeks of sedentary life style, randomization decides whether they start with exercise or~     with being couch potatoes. All participants are also randomized to also consume 150 g of~     blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a~     week during the 4 week period. The exercise period and the couch period are started and~     ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk~     factors are measured before and after this run, ie 8 times in total.~   "
136056|NCT01274065|"~     There is no common rule as to how a drug will affect patients. This is due to the effect~     specific DNA sequences of genes have on drug response, by the effect they have on how~     medications are metabolized. The primary objective of this research is to optimize~     medication therapy and to reduce the number of medications used, specifically medications~     for people with developmental disabilities and co-occuring psychiatric illnesses.~   "
136070|NCT01273883|"~     The purpose of this study was to examine any potential benefit in lessening the severity of~     tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with~     magnesium (532 mg daily).~   "
136057|NCT01274052|"~     The researchers investigated nineteen pregnant women in third trimester and again~     postpartum. At the experimental days we performed a mealtest and drew blood for analyses of~     glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP),~     insulin, C-peptide and glucagon.~      The researchers aimed to investigate whether women with gestational diabetes mellitus~     exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases~     following delivery when normal glucose tolerance is reestablished.~   "
136058|NCT01274039|"~     Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this,~     trabeculectomy is more likely to fail. The investigators exchange the local therapy by~     systemic therapy using acetazolamide and measure the eye pressure using local therapy and~     systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure~     using acetazolamide compared to local therapy. In summary acetazolamide could be a better~     choice in reference to conjunctival inflammation, but a worse choice in reference to~     controlling eye pressure.~   "
136059|NCT01274026|"~     This study seeks to establish evidence:~        1. that physiologic changes, unrelated to effect on the PAH enzyme, occur in PKU patients~          who are treated with Kuvan® therapy,~        2. that these changes may be caused by enhanced neurotransmitter synthesis in the brain or~          an upregulation of gene expression (increasing the ability of genes to produce~          functional enzymes),~        3. and that beneficial changes in behavior and cognition, especially executive functioning~          skills may result.~      The objective of this study is to correlate any change in behavior and executive function~     skills of PKU patients who are non-responsive to sapropterin effect on the PAH enzyme, as~     defined by lowered blood PHE levels, with urine neurotransmitter levels and broad gene~     expression prior to and after sapropterin administration.~      Expected outcomes would include evidence of sapropterin effects on upregulation of enzymes~     other than PAH that control neurotransmitter synthesis, and any resulting correlation with~     behavioral and cognitive changes.~      The investigators hope this study will inform further detailed investigations into the~     biochemical and molecular actions of sapropterin (Kuvan®) that lead to increased~     understanding of possible treatment effects beyond a lowered blood PHE response.~   "
136060|NCT01274013|"~     The objective of this study is to assess the prevalence of vitamin D deficiency in patients~     with chronic Hepatitis C compared to a matched control group of healthy individuals in the~     Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more~     common in patients with chronic Hepatitis C compared to the healthy control group.~   "
136061|NCT01274000|"~     A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with~     diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.~   "
136062|NCT01273987|"~     Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of~     uterus could improve neobladder empty after radical cystectomy in female patients with~     bladder cancer compared to present standard neobladder~   "
136063|NCT01273974|"~     The purpose of this study is to determine whether half-dose intradermal influenza vaccine is~     as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.~   "
136064|NCT01273961|"~     The purpose of this pilot research study is to collect information on the safety and~     effectiveness of an experimental device used to treat and improve the appearance of the skin~     by reducing the visibility of wrinkles and by reducing the looseness of skin.~   "
136065|NCT01273948|"~     This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab~     combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible~     patients with normal coagulation, hematological, and renal function will undergo a~     screening/washout period of up to 28 days, followed by randomization to receive weekly~     bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.~      The primary endpoint of this study is the proportion of patients who show a greater than or~     equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early~     virological response; EVR).~      Secondary endpoints include the proportion of patients with an undetectable HCV RNA level~     after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA~     level of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for~     individual patients over time, and comprehensive evaluation of the safety and tolerability~     of bavituximab infusion.~   "
136066|NCT01273935|"~     The aim of this study is to evaluate the low-response prevalence of early antiplatelet~     therapy and to test the influence of different aspirin dosages in patients with acute~     ischemic strokes (AIS).~   "
136067|NCT01273922|"~     This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study~     using two dose levels of an investigational vaccine directed against S. aureus and Candida.~     The study is designed to evaluate the safety, tolerability and immunogenicity of the~     investigational vaccine, NDV-3~   "
136068|NCT01273909|"~     The goal of this prospective, observational study is to investigate the clinical,~     psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap~     reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for~     the treatment of lymphedema.~      The investigators hypothesize that (1) perforator flap breast reconstruction will result in~     excellent clinical, psychosocial, and patient satisfaction outcomes compared to~     non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is~     associated with less persistent postsurgical pain than other forms of breast reconstruction,~     even after controlling for major cofactors, such as the extent of auxiliary lymph node~     dissection and the use of radiation therapy; (3) perforator flap reconstruction for the~     treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and~     complications of lymphedema.~   "
136069|NCT01273896|"~     The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the~     patient and their breast cancer.~      STA-9090 is an experimental drug that works by breaking down cancer proteins. When the~     cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that~     is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug~     Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose~     for this drug has been found. We are now interested to see how active this drug is against~     breast cancer.~   "
136071|NCT01273870|"~     The aim of the dialyzer evaluation is to compare performance characteristics and~     haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux~     dialyzers~   "
136072|NCT01273857|"~     Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are~     characterized by hypoplasia of the left heart and the aorta with compromised systemic~     cardiac output. Infants with the syndrome generally undergo a staged surgical approach in~     view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and~     related single ventricle physiology has improved markedly with advances in medical and~     surgical therapies, a growing number of infants will ultimately require heart~     transplantation for end-stage heart failure due to several potential disadvantages include a~     negative effect on right ventricular function, arrhythmia, additional volume load via~     regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.~      Risk factors for poor outcome of heart transplantation with HLHS and single ventricle~     physiology are older age at transplantation and previous Fontan operation. New strategies~     are needed to improve the underlying transplant risks proper for the Fontan failure~     patients.~      Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved~     cardiac function in patients with ischemic heart disease. In this trial, the investigators~     aimed to test the safety and feasibility of intracoronary injection of autologous cardiac~     progenitor cells in patients with HLHS and related single ventricle anomalies and that could~     improve ventricular function at 3 months' follow up.~   "
136073|NCT01273844|"~     To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone)~     followed by autologous hematopoietic stem cell transplantation as an initial treatment in~     patients with newly diagnosed AL.~   "
136074|NCT01273831|"~     The purpose of this study is to determine which drug makes lower intraocular pressure~   "
136075|NCT01273818|"~     Aim of this study is to measure the effectiveness of topical gentamicin to prevent~     post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is,~     if it is effective as a prophylactic agent, to compare it's effect with intra venous single~     dose cefazolin sodium prophylaxis.~   "
136076|NCT01273805|"~     Hydroxychloroquine is approved for the treatment of non-cancerous illnesses such as~     rheumatoid arthritis and systemic lupus erythematous. Researchers in the laboratory have~     tested tumors from patients with pancreatic cancer and have discovered that they have~     certain pathways inside the cells that promote growth and survival of the tumor.~     Hydroxychloroquine may inactivate these pathways and results in the death of pancreatic~     cancer cells.~   "
136077|NCT01273792|"~     Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult.~     The aim of this investigation is to identify relevant biomarkers and to elucidate the~     pathogenesis of Susac syndrome~   "
136078|NCT01273779|"~     Study will evaluate the safety and potential benefit of talactoferrin (recombinant human~     lactoferrin) as an addition to the standard care for severe sepsis.~   "
136079|NCT01273766|"~     RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.~      PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood~     transfusions in patients with hematologic malignancies.~   "
136080|NCT01273753|"~     The purpose of this study is to examine the impact of exercise during dialysis using~     objective measures of fluid status determination, specifically bioimpedance analysis (BIA)~     and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be~     associated with more stable blood pressures and that this will be reflected in different~     output from BIA and BVM monitoring.~   "
136081|NCT01273740|"~     Randomized study to evaluate the effect of adding external support to PTFE-grafts used for~     bypass to below knee arteries in patients with critical limb ischemia with respect to~     primary patency, secondary patency, and limb salvage.~   "
136082|NCT01273727|"~     An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion~     of vision and lead to swelling, or macular edema. Despite surgery to remove the scar~     tissue(membrane peeling), residual swelling of the retina may continue to interfere with~     vision.~      In this study the investigators will inject an implantable steroid device into the back,~     fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the~     retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by~     the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system~     in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug~     Administration (FDA) for decreasing swelling due to another condition in the eye. This study~     will help to find out whether or not this device Ozurdex™ is also effective for reducing the~     swelling of the retina in patients who have already had surgery to remove scar tissue on the~     retina.~   "
136083|NCT01273714|"~     The extent of thyroid resection in benign goiter is controversial. Potential advantages of~     TT over BST may include: one-stage removal of incidental thyroid cancer reported in up to~     10% of operatively treated benign thyroid diseases, and lower risk for goiter recurrence.~     However, these potential advantages should outweigh the risk of morbidity associated with~     more radical thyroid resection.~      The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total~     thyroidectomy (TT) for benign bilateral thyroid disease.~   "
136084|NCT01273701|"~     The hospital where this study will be conducted is responsible for the one-year contingency~     management treatment for methamphetamine drug offenders referred from the Yunlin District~     Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get~     slow prosecutions.~      It is an open-label, parallel-group trial comparing the combination of psychosocial~     intervention and slow prosecutions with psychosocial intervention alone in treating subjects~     with methamphetamine dependence~      Study Hypothesis~        1. Psychosocial interventions in combination with slow prosecutions is more effective than~          psychosocial interventions alone to achieve abstinence for subjects with~          methamphetamine abuse/dependance.~        2. Inclusion of telephone reminding before each visit will enhance the retention rate and~          abstinence rate.~   "
136085|NCT01273688|"~     Lateral epicondylitis is a painful overuse condition also described as lateral elbow~     tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy~     has striking clinically and histologically similarities. As such, neovascularisation closely~     related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical~     use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a~     painful eccentric training (supination and pronation) with or without a orthopedic elbow~     brace in lateral epicondylitis.~   "
136086|NCT01273675|"~     It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major~     risks of chronic kidney disease. Current guidelines recommend screening kidney estimated~     glomerular filtration function with serum creatinine. But it is not the utmost effective~     method and the GFR would be underestimated. Since good correlation was noticed between serum~     creatinine and chronic kidney disease, urinary microalbumin levels is better for patients~     with risks of chronic kidney diseases. With adequate and early education, or~     antihypertensive agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin~     II receptor blockers (ARB), all could alleviate renal function deterioration and the~     severity of proteinuria. As a result, high sensitive methods is urgent and needed for early~     screening and diseases following up under medication with ACEi and ARB in chronic kidney~     disease patients. In this project, the investigators are going to include the patients with~     typy II diabetes mellitus combining with hypertension who are treated with antihypertensive~     agents. Such volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic~     blood pressure <130 mm/Hg, diastolic blood pressure < 80 mm/ Hg as the goal. Therefore, this~     project would make effort on correlation with urinary microalbumin and other biomarkers~     changes under Candesartan treatment- one of ARB medication for 12 weeks, and further~     exploration of new biomarkers that may be related to renal parenchymal injuries.~   "
136087|NCT01273662|"~     This is a phase II study of axitinib as the second-line on the treatment of advanced~     hepatocellular carcinoma (HCC).~      The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor~     effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks~     without progression of tumor-related symptoms.~   "
136088|NCT01273649|"~     Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major~     problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous~     studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can~     effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.~      Objective:~      To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in~     subjects with ACL reconstruction.~      Design:~      Prospective study.~      Subjects:~      Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an~     ACL reconstruction surgery.~      Methods:~      Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and~     rate of force development are measure at presurgery, 3-month, 6-month after surgery. After~     surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes~     cryotherapy and exercise training with TENS.~      Data analysis:~      Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will~     be used to analysis data.~   "
136089|NCT01273636|"~     Objective: To examine the risk factors for coexisting endometrial carcinoma in patients with~     endometrial hyperplasia.~      Method: Seventy-seven patients who received hysterectomy for endometrial hyperplasia were~     enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial~     carcinoma group (20) depending on the final pathology. Clinical variables were analyzed.~   "
136090|NCT01273623|"~     To investigate the treatment effects with the Jetstream G3 System in moderate to severely~     calcified peripheral artery disease in the common femoral, superficial femoral or popliteal~     arteries using intravascular ultrasound (IVUS).~   "
136091|NCT01273610|"~     This phase II trial studies the side effects and how well lapatinib ditosylate and~     trastuzumab work in treating older patients with human epidermal growth factor receptor 2~     (HER2)-positive breast cancer that has spread from where it started to nearby tissue or~     lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib~     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different~     ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help~     kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together~     with trastuzumab may kill more tumor cells.~   "
136092|NCT01273597|"~     This observational study will evaluate the clinical benefit of Zemplar (paricalcitol~     injection) in daily routine practice in end-stage renal disease patients with severe~     over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will~     be collected from participants initiated on Zemplar therapy according to standard of care.~     The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the~     proportion of participants achieving target parathyroid hormone levels, and prevalence of~     elevated serum calcium and phosphate levels will be evaluated.~   "
136093|NCT01273584|"~     Obesity is on the rise in all developed countries. Of particular concern is that more young~     people including children are being recognised as being overweight or obese. We know from a~     recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH,~     that obesity is a major risk both for the mother and her child. When all deaths in women~     during pregnancy are analysed, obesity comes out as the most common risk factor. Babies of~     obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive~     Care Unit.~      Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and~     increasing physical activity. Unfortunately these measures are often insufficient to produce~     significant improvements in weight. If obese women gain little or even no weight during~     pregnancy, the outcome of the pregnancy is known to be improved. This was shown in a very~     large study of more than 120, 000 obese women.~      The drug metformin has been used for years in the treatment of diabetes and more recently~     for polycystic ovary syndrome (PCOS). Studies in pregnant PCOS women and women with diabetes~     in pregnancy have shown it to be safe and effective. Fortunately it is relatively cheap and~     taken as a tablet with meals.~      Metformin has the great advantage of not causing weight gain and often leads to a small~     amount of weight loss. It works by improving the body's sensitivity to insulin which is~     important as resistance to insulin is common in obesity.~      We have a lot of experience using metformin to treat women with diabetes in pregnancy where~     it is greatly beneficial. We now wish to examine its potential for obese women who do not~     have diabetes. We are hoping to show that it will benefit these women by causing less weight~     gain, less high blood pressure, and less diabetes. We anticipate babies will also have~     better birth weights, will be easier to deliver naturally, will not need to go to special~     care baby units and will be healthier.~   "
136094|NCT01273571|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.~   "
136095|NCT01273558|"~     The purpose of this study is to compare the results from two methods used to determine the~     renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at~     which appreciable amounts of glucose appear in the urine) in untreated patients with type 2~     diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg~     once-daily canigliflozin for 8 days.~   "
136096|NCT01273545|"~     This study will use electronic health services databases to describe the usage patterns of~     dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the~     extent and proportion of patients with characteristics suggestive of the use of PRILIGY~     within, versus outside of the intended use population.~   "
136097|NCT01273532|"~     The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503)~     dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in~     healthy Japanese male participants.~   "
136098|NCT01273519|"~     The purpose of this study is to assess whether or not adalimumab (Humira®) can influence~     pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA)~     and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a~     contraindication for adalimumab as stated in the released summary of product~     characteristics. Therefore it shall be evaluated if pain medication which is used in these~     participants is changed, reduced or stopped due to adalimumab treatment.~   "
136099|NCT01273506|"~     The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503)~     dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in~     healthy Japanese male participants.~   "
136100|NCT01273493|"~     The purpose of this study is to characterize the pharmacokinetics (blood levels) of~     trabectedin after administration to patients with advanced malignancies and hepatic (liver)~     dysfunction.~   "
136101|NCT01273480|"~     The purpose of this study is to evaluate the potential effects of rifampin on blood levels~     of trabectedin after administration to patients with advanced malignancies.~   "
136102|NCT01273467|"~     The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007)~     in patients who have suffered a stroke. The study is not designed to establish efficacy,~     although preliminary explorations will be conducted.~   "
136103|NCT01273454|"~     This study aims to collect clinical information and to examine the usefulness and safety of~     ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients~     with drug is as per physician discretion and that doses are determined based upon approved~     labeling recommendations and physician discretion.~   "
136104|NCT01273441|"~     Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors~     (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of~     duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so~     it is cost-effective.~      Eradication therapy has changed over time. The usually recommended pattern in the consensus~     conferences has traditionally been triple therapy, composed by the combination of 2~     antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor~     (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate~     after standard triple therapy is less than 80%. Several European studies have found even~     lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment~     failure leads to a second treatment and a new diagnostic test to confirm eradication.~   "
136105|NCT01273428|"~     Testing a drug and a device for the treatment of pressure ulcers, compared with current~     treatments.~   "
136106|NCT01273415|"~     Gene expression studies have identified at least four molecularly distinct subtypes of~     breast cancer including two biologically distinct ER-positive subtypes of breast cancer:~     luminal A and luminal B (with luminal B tumors having poorer outcomes than luminal A~     tumors). Although some luminal B tumors can be identified by their expression of HER2, the~     major biological distinction between luminal A and B is the proliferation signatures,~     including genes such as CCNB1, MKI67, and MYBL2, which have higher expression in luminal B~     tumors than in luminal A tumors. The high cost of gene expression profiling has limited its~     incorporation into general clinical practice. To date, there is no available IHC-based~     surrogate assay that can distinguish between luminal A and luminal B tumors. We hypothesized~     that the IHC determination of the Ki67 index as well as ER, PgR, and HER2 status is able to~     distinguish the luminal B subtype of breast cancers from the luminal A subgroup.~   "
136107|NCT01273402|"~     This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting~     the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose~     of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2~     will be studied in the first part.~      Once an appropriate TF2 dose is selected based on information learned from the first 2 dose~     levels, patients will be enrolled onto several different increasing dose levels of~     90Y-IMP-288.~   "
136108|NCT01273389|"~     The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered~     intravenously in patients with active, International Society of Nephrology/Renal Pathology~     Society Class III and IV Lupus Nephritis (LN).~   "
136109|NCT01273376|"~     The purpose of this study is to determine whether RX-10100 are effective in the treatment of~     Major Depressive Disorder (MDD).~   "
136110|NCT01273363|"~     To assess asthma control in Russian patients according to the new criteria provided in the~     international guidelines and identify pharmacological approaches that provide a higher level~     of overall asthma control~   "
136111|NCT01273350|"~     Prospective, non-randomized, single-center cohort study treating internal carotid artery~     stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in~     conjunction with bivalirudin as the procedural anticoagulation~   "
136112|NCT01273337|"~     The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by~     intracarotid infusion and to assess efficacy of treatment in subjects who have had~     unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA).~     ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the~     stroke.~   "
136127|NCT01273142|"~     The purpose of this study is to demonstrate the difference in frequency and level of liver~     function disturbance between patients on efavirenz based ART, and patients on nevirapine~     based ART in HBV and HCV co-infected patients, (and/or with patients with abnormal liver~     function prior to ART), in China. Liver function tests will be measured at baseline and~     follow-up.~   "
136260|NCT01271413|"~     This research is being done to learn if computer tasks that challenge the brain (cognitively~     stimulating tasks) can improve memory and other types of thinking. The study will compare~     the effects of different versions of the computer tasks. It also will compare the task~     performance of different groups of people.~   "
136113|NCT01273324|"~     The dual mobility design concept for acetabular liners, as is used in the Restoration ADM~     Acetabular System, has been applied in various implants since its introduction by Gilles~     Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have~     been particularly lauded for low incidence of dislocations. However, the wear performance of~     this design concept has not been proven to date. As wear particles are a possible~     contributing factor in aseptic loosening, the assessment of wear and fixation is an~     important step in proving this implant design.~      The proposed study will combine RSA and peri-prosthetic bone mineral density as well as~     outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation,~     polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular~     System.~   "
136114|NCT01273311|"~     Background:~      - The Coronary Artery Risk Development in Young Adults (CARDIA) study is an investigation of~     cardiovascular risk factors among African-American and white young adults between 18 and 30~     years of age, first recruited in 1985 86 from Birmingham, AL; Chicago, IL; Minneapolis, MN;~     and Oakland, CA. The study has examined a wide variety of risk factors, including insulin~     resistance, obesity, and diabetes. Based on 20 years of followup, the data provide evidence~     of an increase in the prevalence of many cardiovascular risk factors, as well as other~     factors that may lead to brain disease. To further evaluate these changes, the CARDIA Year~     25 Exam will include a brain imaging component to study brain structure and function in a~     subset of CARDIA participants.~      Objectives:~      - To conduct brain magnetic resonance imaging as part of a 25-year followup study on~     participants in the original CARDIA study of heart disease risk factors in young adults.~      Eligibility:~      - Existing CARDIA study participants in the Minneapolis, MN, and Oakland, CA regions.~      Design:~        -  Participants will be screened with a full medical history and physical examination. -~          Participants will have an MRI scan at the 25-year followup examination for the CARDIA~          study.~        -  No additional testing or treatment will be required for this protocol.~   "
136115|NCT01273298|"~     Patients with chronic obstructive pulmonary disease (COPD) are at greater risk of suffering~     from diseases for which beta-blockers may be indicated and effective. Clinicians remain~     hesitant to administer beta-blockers to COPD patients for fear of adverse effects on lung~     function. However, cardioselective beta-blockers therapy led to a non-significant worsening~     of resting expiratory flow limitation measured by the forced expiratory volume in one second~     (FEV1) as compared to placebo. But, the FEV1 appears to be a crude estimate bronchial~     obstruction in COPD. Importantly, the effects of cardioselective beta-blockers on dynamic~     hyperinflation, a subtle marker of bronchial obstruction, remain unknown. Thus, a~     prospective placebo-controlled study assessing the effects of short-term cardioselective~     beta-blocker therapy on dynamic hyperinflation in patients with moderate-to-severe COPD is~     needed.~   "
136116|NCT01273285|"~     To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer~     thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and~     to compare these results to conventional Time-Domain-OCT (TD-OCT).~        -  Trial with medical device~   "
136117|NCT01273272|"~     The purpose of this study is to determine whether a comprehensive cognitive-behavioral~     therapy-based, multi-component treatment programme is effective in the treatment of~     neuropsychiatric symptoms of patients with mild Alzheimer's dementia.~   "
136118|NCT01273259|"~     DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic~     hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in~     human. The purpose of this study is to determine if DHEA is effective in the treatment of~     respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease~     (COPD) on exercise capacity and haemodynamic variables. Patients will receive after~     randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation~     concerns clinical parameters, echocardiography and right catheterization after and before~     treatment. Primary end-point is the six-minute walk test. This is a prospective double~     blind, randomised, placebo controlled study which will be realized in four university~     hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.~   "
136119|NCT01273246|"~     A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine~     in healthy children (3-11y) and infants (6-35m).~   "
136120|NCT01273233|"~     A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type~     71 Vaccines in healthy adults~   "
136121|NCT01273220|"~     Background:~      - Alcohol use disorders are the most prevalent mental disorders in the United States and are~     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain~     types of cancer and chronic illness. Research into better treatment methods for alcohol use~     disorders and their associated disabilities requires a broad amount of information on the~     genetic and environmental factors that predispose certain individuals to alcoholism. To~     improve the quality of available information for research, the National Institutes of Health~     is conducting a nationwide survey on alcohol use disorders and related physical and mental~     disabilities, and will collect genetic information through saliva samples.~      Objectives:~      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized~     population, 18 years and older, in order to study the extent of and contributing factors to~     alcohol use and abuse in the United States.~      Eligibility:~      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,~     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and~     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).~      Design:~        -  The study will involve three main components: an automated computer-assisted interview,~          an automated questionnaire, and the collection of a saliva sample.~        -  Participants will be recruited through community through publically available U.S.~          Census Bureau files.~        -  The interview and questionnaire will ask standardized questions related to personal~          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and~          eating conditions that frequently co-occur with alcohol and drug use disorders;~          tobacco, medicine and drug use and disorders; selected personality traits, including~          behavior; alcohol, drug, and mental health treatment utilization; and medical~          conditions related to alcohol consumption.~        -  Participants will provide a saliva sample for genetic study.~      Background:~      - Alcohol use disorders are the most prevalent mental disorders in the United States and are~     a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain~     types of cancer and chronic illness. Research into better treatment methods for alcohol use~     disorders and their associated disabilities requires a broad amount of information on the~     genetic and environmental factors that predispose certain individuals to alcoholism. To~     improve the quality of available information for research, the National Institutes of Health~     is conducting a nationwide survey on alcohol use disorders and related physical and mental~     disabilities, and will collect genetic information through saliva samples.~      Objectives:~      - To collect interview data and saliva samples from the U.S. civilian noninstitutionalized~     population, 18 years and older, in order to study the extent of and contributing factors to~     alcohol use and abuse in the United States.~      Eligibility:~      - Individuals at least 18 years of age who do not live in institutions (i.e., prisons,~     inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and~     the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).~      Design:~        -  The study will involve three main components: an automated computer-assisted interview,~          an automated questionnaire, and the collection of a saliva sample.~        -  Participants will be recruited through community through publically available U.S.~          Census Bureau files.~        -  The interview and questionnaire will ask standardized questions related to personal~          history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and~          eating conditions that frequently co-occur with alcohol and drug use disorders;~          tobacco, medicine and drug use and disorders; selected personality traits, including~          behavior; alcohol, drug, and mental health treatment utilization; and medical~          conditions related to alcohol consumption.~        -  Participants will provide a saliva sample for genetic study.~   "
136150|NCT01272843|"~     The carotid arteries are blood vessels in the neck that supply blood to the brain. Carotid~     stenosis disease is defined as a narrowing of these arteries due to the build up of plaque.~     The plaque material can also break off and move into the brain. The resulting blockage of~     blood supply to a portion of the brain is what causes 80% of all strokes. One treatment~     option is to have surgery on the carotid artery and remove the plaque. This procedure is~     called a carotid endarterectomy (CEA). There is evidence that proves CEA reduces the risk of~     stroke. The objective of this research project is to determine who is most likely to benefit~     from CEA surgery.~   "
136151|NCT01272830|"~     This research study is being conducted to determine if taking oral (by mouth in pill form)~     Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and~     improve function of non-infected symptomatic postoperative total joint replacements.~   "
136122|NCT01273207|"~     Bronchiolitis Obliterans (BO) is an obstructive lung disease that can affect individuals~     that have undergone a lung or hematopoietic stem cell transplant. BO has been studied most~     extensively in lung transplant recipients, where it is considered to represent chronic lung~     rejection. It is the leading cause of death after lung transplant, with mortality rates up~     to 55 percent. In hematopoietic stem cell transplantation, BO is thought to be a~     manifestation of chronic graft-vs-host disease (GVHD). Up to 45 percent of patients~     undergoing hematopoietic stem cell transplantation at the NHLBI develop a decline in~     pulmonary function. Conventional therapy for patients who develop BO consists of~     augmentation of systemic immunosuppressants. Systemic immunosuppression has limited efficacy~     for BO and is associated with deleterious consequences including increased risk of~     infections and decreased graft-versus tumor/leukemia effects.~      Recently, cyclosporine inhalation solution (CIS) in solution with propylene glycol has been~     shown to improve overall survival and chronic rejection-free survival in lung transplant~     patients. These findings suggest targeted delivery of immunosuppressive therapy to the~     diseased organ warrants further investigation as this may minimize the morbidity associated~     with systemic immunosuppression. However, there currently exists limited data regarding the~     overall efficacy of inhaled cyclosporine to treat established BO following lung~     transplantation. Furthermore, inhaled cyclosporine has not been studied in the treatment of~     BO following hematopoietic stem cell transplantation.~      Here, we propose to evaluate the long-term safety and efficacy, of inhaled CIS for the~     treatment of BO. Enrollment will be offered to subjects who have completed the end of study~     (week 18 visit) for the initial protocol (Phase II Trial of CIS in lung transplant and~     hematopoietic stem cell transplant recipients for treatment of Bronchiolitis Obliterans) and~     who have shown evidence of benefit (either an improvement or stabilization) in BO/BOS with~     CIS treatment.~      Clinical parameters, including pulmonary function tests, will be measured in addition to~     laboratory markers of the anti-inflammatory response to CIS. Adverse events associated with~     extended treatment with CIS will be recorded.~      The primary objective is to provide long-term safety and efficacy data for the use of CIS in~     hematopoietic transplant patients and lung transplant patients with established BO.~      Secondary objectives include investigation of the inflammatory pathways that lead to chronic~     BO and ascertainment of the long term anti-inflammatory effects of this CSA preparation ex~     vivo and in vivo.~      Primary endpoint is the efficacy of extended use CIS for BO/BOS. Secondary endpoints include~     the toxicity profile (adverse events), improvement in high resolution chest CT images,~     results of peripheral blood and bronchoalveolar cytokine arrays to assess secondary markers~     of inflammation, and functional capacity measurements using a six-minute walk test.~   "
136123|NCT01273194|"~     Background:~      - Palliative care, also known as comfort care, is intended to keep a patient comfortable by~     focusing on pain and symptom management to improve quality of life. Although palliative care~     has been demonstrated to be beneficial, it is underutilized in children who have been~     diagnosed with cancer, because current trends favor palliative care primarily at the end of~     life and in only a small number of patients. Children with cancer likely would benefit from~     the incorporation of palliative care from the time of diagnosis, but both doctors and~     families are often reluctant to include it for a variety of reasons. Researchers are~     interested in understanding these reasons to determine better ways to include palliative~     care as part of cancer treatment methods in children with cancer.~      Objectives:~      - To collect information on pediatric oncology patients and their parents attitudes towards~     palliative care, along with cancer treatment, from the time of diagnosis.~      Eligibility:~        -  Children and adolescents between 10 and 17 years of age who have been diagnosed with~          cancer in the past year.~        -  Parents of eligible children.~      Design:~        -  Participants will complete a 30-minute survey about experiences with pain, symptom~          management, and focus on quality of life in the first month following cancer diagnosis.~          Child participants will be asked about their views on the importance of quality of life~          in the beginning of their illness, as well as their attitudes toward symptom-oriented~          care. Parent participants will be asked questions about their child s illness, which~          includes understanding, discussion, and impact of illness.~        -  Treatment will not be provided as part of this protocol.~   "
136124|NCT01273181|"~     Background:~      - MAGE-A3/12 is a type of protein commonly found on certain types of cancer cells,~     particularly in metastatic cancer. Researchers have developed a process to take lymphocytes~     (white blood cells) from cancer patients, modify them in the laboratory to target cancer~     cells that contain MAGE-A3/12, and return them to the patient to help attack and kill the~     cancer cells. These modified white blood cells are an experimental treatment, but~     researchers are interested in determining their safety and effectiveness as a possible~     treatment for cancers that involve MAGE-A3/12.~      Objectives:~      - To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for~     metastatic cancers that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma,~     renal cell cancer, or another type of metastatic cancer that has not responded to standard~     treatment.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, tumor samples, and imaging studies.~        -  Participants will have leukapheresis to collect enough white blood cells for~          modification in the laboratory.~        -  Seven days before the start of anti-MAGE-A3/12 treatment, participants will have~          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in~          preparation for the treatment.~        -  After the last dose of chemotherapy, participants will receive the anti-MAGE-A3/12~          cells as an infusion for 20 to 30 minutes, followed by a dose of interleukin-2 to keep~          the anti-MAGE-A3/12 cells alive and active as long as possible. Participants will also~          receive filgrastim to encourage the production of blood cells.~        -  Participants will remain in the hospital to be monitored for possible side effects, and~          after release from the hospital will have regular followup exams with blood samples and~          imaging studies to evaluate the effectiveness of the treatment....~   "
136125|NCT01273168|"~     Background:~        -  Some types of cancer cells that have hormone receptors on their surfaces need the~          hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor~          cells, which helps to slow or stop the growth of cancer. Tamoxifen has been approved~          for treatment of certain types of estrogen-linked cancers, such as breast and ovarian~          cancer.~        -  The experimental drug Z-Endoxifen HCl (endoxifen) is related to tamoxifen, and has been~          shown to work against similar estrogen-linked cancers. In many cancer patients,~          tamoxifen is turned into endoxifen by enzymes in the liver; however, not all people~          have the liver enzymes that can turn tamoxifen into endoxifen, which means that the~          drug cannot work properly. Taking certain other drugs at the same time as tamoxifen can~          also keep it from turning into endoxifen. Researchers are interested in determining~          whether endoxifen tablets are effective in slowing or stopping tumor growth in~          individuals whose hormone-linked tumors have not responded to standard treatment.~      Objectives:~      - To test the safety and effectiveness of daily endoxifen in individuals with hormone~     receptor positive solid tumors that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with hormone receptor~     positive solid tumors (breast or other tumors), desmoid tumors, or gynecologic tumors that~     have not responded to standard treatment.~      Individuals with breast cancer must have had at least one prior chemotherapy regimen and one~     prior hormonal regimen for metastatic disease.~      Design:~        -  Participants will be screened with a full medical history (including prior hormone use)~          and physical examination, as well as blood and urine tests, tumor imaging studies, and~          an eye examination.~        -  Participants will take endoxifen tablets daily for 28-day cycles of treatment, and will~          be asked to keep a medication diary to record any side effects.~        -  Participants will have regular clinic visits with blood and urine samples and imaging~          studies to evaluate the cancer's response to treatment.~        -  Participants will continue to take endoxifen for as long as the cancer responds to the~          treatment.~   "
136126|NCT01273155|"~     Background:~      - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes~     that limit cell growth and survival of the tumor that are switched off in cancer cells.~     Belinostat has been given to patients with different types of cancer to measure its safety~     and effectiveness, but it has not been given in a formal trial to cancer patients who have~     abnormal liver function. Because belinostat is processed by the liver, its safety and~     effectiveness needs to be established in individuals who have abnormal liver function.~     Researchers are interested in comparing the effects of belinostat as a cancer treatment drug~     in individuals with normal and abnormal liver function.~      Objectives:~        -  To test the safety and effectiveness of belinostat in individuals who have solid tumors~          and lymphomas and who also have abnormal liver function.~        -  To compare the results of belinostat treatment in individuals with normal and abnormal~          liver function.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with solid tumors or~          lymphomas that have not responded to standard treatment.~        -  Individuals with normal liver function and varying degrees of abnormal liver function~          (mild, moderate, severe) are eligible.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests, and tumor imaging studies. Participants will then be~          divided into study groups based on their liver function.~        -  Participants will receive belinostat in cycles of treatment. Except for cycle 1, all~          cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants~          will receive a single dose of belinostat 1 week before the regular 21-day treatment~          cycle starts.~        -  In each cycle, participants will receive belinostat once a day for 5 days, and will be~          asked to keep a medication diary to record any side effects.~        -  Participants will have regular clinic visits with blood and urine samples and imaging~          studies to evaluate the cancer s response to treatment.~        -  Participants may continue to take belinostat for as long as the cancer responds to the~          treatment....~   "
136128|NCT01273129|"~     Background:~      - Medically intractable epilepsy is the term used to describe epilepsy that cannot be~     controlled by medication. Many people whose seizures do not respond to medication will~     respond to surgical treatment, relieving seizures completely or almost completely in~     one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed~     as part of this treatment are not experimental, but researchers are interested in training~     more neurologists and neurosurgeons in epilepsy surgery and care in order to better~     understand epilepsy and its treatment.~      Objectives:~      - To use surgery as a treatment for medically intractable epilepsy in children and adults.~      Eligibility:~      - Children and adults at least 8 years of age who have simple or complex partial seizures~     (seizures that come from one area of the brain) that have not responded to medication, and~     who are willing to have brain surgery to treat their medically intractable epilepsy.~      Design:~        -  Participants will be screened with a medical history, physical examination, and~          neurological examination. Imaging studies, including magnetic resonance imaging and~          computer-assisted tomography (CT), may also be conducted as part of the screening.~          Participants who do not need surgery or whose epilepsy cannot be treated surgically~          will follow up with a primary care physician or neurologist and will not need to return~          to the National Institutes of Health for this study.~        -  Prior to the surgery, participants will have the following procedures to provide~          information on the correct surgical approach.~        -  Video electroencephalography monitoring to measure brain activity during normal~          activities within a 24-hour period. Three to four 15-minute breaks are allowed within~          this period.~        -  Wada test to evaluate speech, comprehension, and memory centers of the brain, using a~          contrast dye to study the blood vessels of the brain and a short-term anesthetic~          administration procedure to test the effects on areas of speech and memory.~        -  Depth electrodes and/or brain surface electrodes to measure brain activities and~          determine the part of the brain that is responsible for the seizures (seizure focus).~        -  Participants will have a surgical procedure at the site of their seizure focus. Brain~          lesions, abnormal blood vessels, tumors, infections, or other areas of brain~          abnormality will be either removed or treated in a way that will stop or help prevent~          the spread of seizures without affecting irreplaceable brain functions, such as the~          ability to speak, understand, move, feel, or see.~        -  Participants will return for outpatient visits and brain imaging studies 2 months, 1~          year, and 2 years after surgery.~   "
136129|NCT01273116|"~     The current organization of hospital care for older patients with complex healthcare needs~     is of insufficient quality, safety and efficiency. Frail older patients have a higher risk~     for development of complications and consequently a higher length of hospital stay, a higher~     risk of functional decline, and higher care needs after discharge. As nearly half of the~     patients admitted to Dutch hospitals is over 65 years, it is highly necessary to adapt the~     organization of hospital care to their needs. Besides having introduced the medical~     specialty geriatrics, hospital management has not started to provide hospital wide~     healthcare tailored to frail older patients. Therefore, the purpose of this study is to~     develop and examine the effectiveness of an intervention program for frail older patients~     admitted to hospital aimed at preventing functional decline and other hospital related~     negative outcomes.~   "
136130|NCT01273103|"~     This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6~     healthy adult male subjects. The study will consist of: Screening evaluations, a treatment~     phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at~     least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg~     containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and~     fecal samples will be collected. Subjects will be required to remain in the unit until the~     radiocarbon excreted falls to less than or equal to 1% of the administered dose for two~     consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will~     be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE~     monitoring, and physical examinations as indicated.~   "
136131|NCT01273090|"~     RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I clinical trial is studying the side effects and best dose of~     imetelstat sodium in treating young patients with refractory or recurrent solid tumors or~     lymphoma.~   "
136132|NCT01273077|"~     Two rotavirus vaccines have been authorized for use in Canada: RotaTeq®, Merck Frost Canada,~     Inc. and Rotarix®, Glaxo Smith Kline (GSK). In contrast to the United States, Australia and~     several other western countries, neither rotavirus vaccine is offered in a publicly funded~     program in Canada. A universal rotavirus immunization program offered to all children has~     the potential to prevent moderate to severe forms of the disease associated with rotavirus,~     with associated decreased disease burden and health care costs. This demonstration project~     seeks to evaluate the effect of the implementation of a universal infant immunization~     program with Rotarix employing two different program delivery models (public health delivery~     or physician office delivery) in comparison to a jurisdiction where routine immunization is~     not provided. Only evaluation of the program will be the subject of this study.~   "
136133|NCT01273064|"~     Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC)~     treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1~     chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).~      Null-responders are defined as patients who failed to achieve a greater than 2 log drop in~     HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels after 12 weeks of~     treatment (know as an early virologic response, or EVR) during previous SOC therapy.~      If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at~     Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that~     patient is not a null-responder, and is excluded from study participation. If, during~     previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must~     have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be~     defined as a null-responder.~      Patients will be screened and have up to 4 weeks to qualify for study entry. During this~     screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients~     will undergo centralized, stratified (based on ethnicity), randomization to one of four~     treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will~     last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo~     patients who do not show a virologic response after 12 weeks of therapy will be rolled onto~     SOC + 15mg CTS-1027, while maintaining the study blind.~   "
136152|NCT01272817|"~     Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses~     including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative~     syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.~   "
136153|NCT01272804|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics~     (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral~     doses in patients with type 2 diabetes.~   "
136154|NCT01272791|"~     The primary objective of this study is to compare the overall survival of patients with~     stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.~   "
136261|NCT01271400|"~     The aim of this study is to track the outcome from the patients who had embryo~     cryopreservation as part of their Advanced Reproductive Technology (ART) treatment at West~     Coast Fertility Centers.~   "
136134|NCT01273051|"~     In the Netherlands approximately 2300 new patients are diagnosed with rectal cancer each~     year. Standard treatment for patients with a T2 or T3 rectal cancer consists of preoperative~     short course of radiotherapy followed by surgery. In advanced cases long course of~     radiotherapy combined with chemotherapy is used instead of a short cause. In some of these~     advanced cases a complete remission is observed after a long course of radio-/chemotherapy.~     Patients who respond well to neo-adjuvant treatment carry a better prognosis.~      Objective of this research is to evaluate whether neo-adjuvant chemo-/radiotherapy in small~     non-advanced rectal cancers can be used to obtain a complete or near complete remission. In~     these patients could a complete resection of the rectum as an organ be avoided by treating~     them with a local excision with the TEM-technique (Transanal Endoscopic Microsurgery) of the~     scar. The advantage for these patients is, that they do not need major abdominal surgery and~     in a substantial number of these patients the rectum can be preserved with a better function~     of continence.~   "
136135|NCT01273038|"~     The aim of the current clinical investigation is to evaluate a new filter.~   "
136136|NCT01273025|"~     The study aims to investigate the pharmacokinetic parameters and its antioxidative effects~     in Thai healthy men.~   "
136137|NCT01273012|"~     The purpose of this study is to determine whether the probiotic Infloran is cost-effective~     in treating acute childhood diarrhea.~   "
136138|NCT01272999|"~     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective~     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.~     It is expected that the effectiveness of Prevnar 13 against ear infections in children will~     be similar to that observed following Prevnar. Pfizer has committed to conduct a~     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.~   "
136139|NCT01272986|"~     This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic~     myocardial ischemic and acute coronary syndrome patients.~   "
136140|NCT01272973|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and~     pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male~     subjects~   "
136141|NCT01272960|"~     In order to determine the timing of LNG-IUS insertion that results in a greater proportion~     of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control~     trial of interval versus immediate post-placenta insertion. Women will be enrolled at~     36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to~     receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8~     weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months~     post-partum to confirm correct position of the LNG-IUS. The primary outcome of this~     sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes~     include assessing the safety of post-placental LNG-IUS insertion and difference in~     acceptability and symptoms experienced by participants. This is a sub-study of the~     Contraceptive Choice Project, a prospective cohort study that aims to improve the use of~     long-acting contraception by removing financial barriers which has already enrolled over~     5,000 patients. Association of this study with CHOICE offers unique advantages including~     infrastructure to support subject recruitment, retention and completion of follow-up as well~     as covering the cost of LNG-IUS devices.~      We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS~     immediately after placenta delivery will have higher rates of LNG-IUS continuation due to~     poor rates of follow up in the interval insertion group. This is likely to be particularly~     noticeable in our patient population, which is largely uninsured with poor access to~     healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping,~     which may be disguised by the post-partum period. Published reports of immediate~     post-placenta insertion focus on expulsion rates and do not report on symptoms and~     satisfaction rates.~   "
136142|NCT01272947|"~     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo~     applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the~     limbs~   "
136143|NCT01272934|"~     The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo~     applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in~     particular with regard to pain relief.~   "
136144|NCT01272921|"~     The duration of motor block for infragluteal parabiceps sciatic nerve block following total~     knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic~     given.~   "
136145|NCT01272908|"~     This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients~     with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or~     current inadequate response to one prior anti-TNF therapy. All patients will receive~     MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase~     of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated~     time on study treatment is 48 weeks.~   "
136146|NCT01272895|"~     All patients who have received GENOUS stent implantation at Queen Mary Hospital for~     treatment of ischemic heart disease are eligible for this study. Those with clinical~     indications to undergo restudy coronary angiogram or staged procedure PCI will be primarily~     recruited into this study.~      Optical coherence tomography (OCT) will be performed early after stent implantation to~     evaluate vascular healing response and neointimal coverage.~   "
136147|NCT01272882|"~     Electrical impedance tomography (EIT) monitoring has been researched as a method to~     determine the spatial impedance distribution in a body cross section, but has yet to become~     an established clinical tool. EIT monitoring gives a dynamic, breath-to-breath measurement~     of both global and regional ventilation. Recently, there has been evidence that EIT~     monitoring has great potential to become a non-invasive bedside tool for assessment of~     regional lung ventilation without documented hazards. Potential applications include any~     adult patients in acute respiratory failure. Data collected from this research may~     contribute to improved patient safety outcomes.~      PURPOSE:~      The purpose of this pilot study is to examine the feasibility of using the EIT monitor in~     intensive care unit (ICU) setting on patients with acute respiratory failure and to compare~     the EIT monitor data to standard of care patient assessments. It is hypothesized that the~     EIT monitor, when applied to adults in acute respiratory failure, will correlate with~     conventional standard of care assessments for these patients.~   "
136148|NCT01272869|"~     The aim of the current clinical investigation is to evaluate a new filter~   "
136149|NCT01272856|"~     The purpose of this study is to test the safety of the study drug abatacept and see what~     effects (good and bad) it has in patients with relapsing polychondritis.~   "
136175|NCT01272518|"~     The purpose of this study is to characterize the behavior of cardiac patients with Mood~     Disorders and its clinical course, interpreting the results from a theoretical framework of~     Chaos Theory and Complexity Theory and Systems as well.~   "
136155|NCT01272778|"~     This placebo-controlled crossover study is intended to measure the effect of four doses of~     lorazepam on brain activity measured by magnetoencephalography (MEG) and~     electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple~     cognition testing on 16 healthy male volunteers. On each of five study days subjects will be~     randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity~     will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to~     medication administration and 2, 4, and 6 hours after medication administration. Blood~     samples to determine medication levels and cognition testing will be performed at~     pre-medication baseline and immediately after each post-medication scan time. Data will be~     analyzed to identify changes in brain activity compared to baseline and placebo~     administration using both standard approaches and the Orasi Synchronous Neural Interaction®~     (SNI) test. This study will test the hypothesis that dose-response changes in brain~     functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects~     after single, acute doses of lorazepam.~   "
136156|NCT01272765|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight change and changes in body composition in subjects who have been taking~     a stable dose of certain anti-psychotic medications for longer than three months.~   "
136157|NCT01272752|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight change and changes in body composition in subjects who have just started~     taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel,~     and/or Zyprexa).~   "
136158|NCT01272739|"~     This is a pilot study to determine the safety and efficacy of an investigational product~     (IHBG-10) on weight loss, and changes in body composition.~   "
136159|NCT01272726|"~     The goal of this research study is to measure what percentage of women who suspect they have~     symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The~     study will also evaluate the influence education on the genetics of ADHD has on a woman in~     her deciding to receive behavioral health treatment for ADHD.~   "
136160|NCT01272713|"~     - Aim~      The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the~     withholding of routine oxygen therapy in patients with acute heart attack leads to reduced~     heart damage compared to the current practice of routine inhaled oxygen for all patients.~      - Background~      There is evidence supporting and refuting the current practice of providing oxygen to all~     patients with acute heart attack. A recent summary of clinical trials suggested that oxygen~     may increase the degree of heart damage during heart attack. It also highlighted that the~     few trials into oxygen therapy were performed before the use of modern medications and~     procedures to treat heart attack and that further studies were urgently needed, using~     contemporary practices.~      - Design~      A total of 334 patients will participate in this randomized controlled trial. Patients in~     this study will receive the best current management and care for their condition. Patients~     will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care~     without oxygen therapy. Patients will then receive standard hospital care, aside from~     allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be~     investigated using routine blood tests. With additional information gathered from other~     aspects of routine heart care including coronary angiogram, electrocardiograms and~     complications of hospital stay. Patients will be followed up at 6 months to determine any~     longer term effects of treatment.~   "
136161|NCT01272700|"~     Prone position in spinal surgery can increase airway pressure and decrease dynamic lung~     compliance by a frame used for postural stabilization. Also, it can increase hemodynamic~     instability such as reduced blood pressure by aggravating cardiac index.~      Former study shows pressure controlled ventilation on the pulmonary mechanics can improve~     alveolar use and oxygenation than volume controlled ventilation. The latter one means~     controlling a patient's breathing completely through tidal volume and set breathing rate.~     This could be useful for the patients not possible to breath by themselves because it~     guarantees the perfect breathing.~      The pressure controlled ventilation is used when there is a possibility to change a~     patient's environment. The pressure will be maintained steadily, but volume and flux will be~     changed. That means through the pressure already set, the whole breathing will be maintained~     from the beginning to end. If a patient's resistance is increased, the volume will be~     decreased even though the way of blood pressure control is same. However, the tidal volume~     per minute can be controlled somewhat and barotrauma can be decreased by controlling~     respiratory rate. Through this study, we are expecting the pressure controlled ventilation~     in prone position can improve lung mechanics and oxygenation.~   "
136162|NCT01272687|"~     The genotype-phenotype correlation in patients with Parkinson's disease with specific~     mutations in the glucocerebrosidase gene (Gaucher gene) is known from own clinical~     experiences as well as from case reports in the literature. The epidemiological study will~     determine the frequency of heterozygous mutations in the glucocerebrosidase gene and~     correlate to the clinical onset and development by measuring and documenting severity of~     symptoms (e.g. cognitive deficits, L-dopa responsiveness, depression) in clinically~     well-characterized Parkinson's patients.~   "
136163|NCT01272674|"~     Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by~     influencing vascular NO bioavailability and concentration and function of endothelial~     progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of~     the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell~     migration and the underlying signaling pathways. Furthermore, the impact of exercise~     training on adiponectin-mediated endothelial progenitor cell migration will be investigated.~   "
136176|NCT01272505|"~     Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are~     some obstacles making this procedure more complex than conventional laparoscopic~     cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that~     may allow simplification of the technique. The investigators will compare the ordinary~     method of single incision laparoscopic cholecystectomy versus harmonic scalpel single~     incision laparoscopic cholecystectomy.~   "
136262|NCT01271387|"~     The purpose of this research study is to understand whether there is any difference in the~     amount of tasimelteon (including its breakdown products) in the blood in individuals with~     mild or moderate liver disease compared to individuals who have normal liver function.~   "
136164|NCT01272661|"~     Breast for Success is a new direct service program focused on overcoming barriers to~     breastfeeding for low-income inner-city mothers by use of a culturally competent and~     home-based educational and support intervention. Key project components include a new~     Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and~     two innovative support plans, the Breastfeeding Doula and Father Support Programs. The~     objective is to increase breastfeeding rates for high-risk inner-city mothers.~      Research Questions to evaluate project feasibility and effectiveness are:~        1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?~        2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all~          mothers?~        3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between~          interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?~        4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?~   "
136165|NCT01272648|"~     This project will test and evaluate a rehabilitation programme, which will empower the mens~     health and give them resources to face at new everyday life.~      The project examines if a focused interdisciplinary intervention has influence of the~     patients generic and specified quality of life after curative radiotherapy due to prostate~     cancer.~      The intervention contains nursing consultation with information about late side effects, an~     individual plan and counselling in toilet habits, smoking cessation, weight control and~     psychological problems after treatment. Furthermore the patients are having physiotherapy~     with pelvic floor examinations. The nurse can refer to other collaborators.~   "
136166|NCT01272635|"~     This protocol is comprised of two separate, but linked, clinical trials for treating~     preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL)~     will try to prevent wheezing illness from developing using azithromycin. If a wheezing~     illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms~     using oral corticosteroids.~   "
136167|NCT01272622|"~     The present investigation is a prospective, multicenter study evaluating craniopharyngioma~     patients' prognoses following the various currently-practiced therapeutic strategies.Primary~     goals of the study are to establish quality standards and compare the various therapy~     strategies with respect to their effectiveness and impact on the quality of life of treated~     patients. A stratified randomization of two treatment arms will be conducted with respect to~     timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose~     tumors are incompletely resected. The researchers will investigate whether an immediate,~     postoperative irradiation is superior to progression-contingent irradiation based on~     alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month~     post op) to 3 years after randomization. Progression-free survival and overall survival will~     be examined as closely-related subgoals.Postoperative data will be evaluated via a~     surveillance study for all complete resection patients as well as for those patients under 5~     years of age regardless of their resection grade.~   "
136168|NCT01272609|"~     Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However,~     many sessions are required and failure or relapses are not uncommon. It has been~     demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those~     failure. The objective of this study is to evaluate the use of a topical beta-blocker~     (timolol 1% gel) as a combination treatment with PDL for treating PWS.~      Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL~     will be performed once a month for 3 months. One group will be treated with PDL alone and~     the other will also applied timolol 1% gel twice a day during treatment. The evaluation will~     be done one month after the third session.~   "
136169|NCT01272596|"~     Impairment of visual deficits, in particular contrast acuity and contrast impairment are~     frequent symptoms in MS. However, visual function is not appropriately covered by the~     standard tools for clinical assessment, namely, the EDSS and the MSFC.~      The primary aim of this study is to investigate, whether in MS patients contrast acuity and~     sensitivity change over a period of two years.~      Secondary aims are the correlation of visual contrast parameters with structural retinal~     changes and quality of life.~   "
136170|NCT01272583|"~     Hypoglycaemia is a well-known complication of insulin treated diabetes. The~     counterregulatory response to hypoglycaemia, with glucagon as the most important mediator,~     is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost~     and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors~     augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The~     investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1~     diabetes will recover the alpha cell response to hypoglycaemia.~   "
136171|NCT01272570|"~     The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral~     conditions in postmenopausal early stage breast cancer survivors within the first 18 months~     of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of~     life among postmenopausal early stage breast cancer survivors who are receiving AI therapy,~     (3) To determine the utilization of dental care among postmenopausal women receiving AIs~     with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs~     negatively impact oral health and oral health quality of life in the setting of breast~     cancer survivors. Further, we hypothesize that dental visits are underutilized in women with~     BCa undergoing adjuvant AI therapy.~   "
136172|NCT01272557|"~     This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to~     determine time to progression of the combination therapy sorafenib plus doxorubicin against~     standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment.~   "
136173|NCT01272544|"~     The aim of this longitudinal study was to assess the oral health of individuals attending a~     mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the~     control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the~     individuals who attended the PPPWB had better oral health status than the control group.~     When the two phases of the study were compared, it was noted that the individuals in the~     second phase had better oral health, although they had a higher score for gingival bleeding.~   "
136174|NCT01272531|"~     This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this~     work is to identify genes associated with good response of patients with bipolar disorder to~     two commonly used mood stabilizing agents, lithium and valproate.~   "
136177|NCT01272492|"~     The investigators are recruiting participants for a randomized controlled trial to evaluate~     the usability and educational value of a nutrition education touchscreen computer program~     targeting Spanish-speaking Latina caregivers of children 2 and under.~      Participants will be randomized to the intervention group - use the computer program and the~     control group - do not use the program. They will be asked basic demographic questions,~     nutrition knowledge questions and computer users will be asked usability questions.~      Objectives are~        1. Evaluate the subjective and objective usability of the touchscreen computer.~        2. Determine whether health knowledge on nutrition topics is enhanced through the use of~          the computer modules.~   "
136178|NCT01272479|"~     The aim of this study is to address questions regarding the link among hepcidin,~     hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to~     address this issue, we planned to measure serum levels of hepcidin prohormone~     (pro-hepcidin), inflammatory and iron parameters.~   "
136179|NCT01272466|"~     Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis~     and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to~     proteasome inhibition present exogene antigens better than unexposed dendritic cells.~     Patients with relapse of multiple myeloma will be offered vaccination with peptides derived~     from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory~     adjuvant. The vaccination will be given in relation to treatment with the proteasome~     inhibitor bortezomib.~   "
136180|NCT01272453|"~     This is a prospective, controlled observational trial of patients undergoing clinically~     indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography~     and coronary CT angiography (CCTA).~   "
136181|NCT01272440|"~     Asparaginase is an important drug i the treatment of childhood leukaemia.~      The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody~     development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.~      Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged~     PEG-asparaginase treatment: A NOPHO ALL-2008 study~      Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study~      Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated~     according to the NOPHO ALL 2008 protocol~      Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing~     interval, adverse effects and EFS, which may lead to improved future therapy~      Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries~   "
136182|NCT01272427|"~     The investigators hypothesize that glucose and whey protein given 30 and 60 min before a~     pizza meal will exert different effects on food intake in adolescent children, and will~     depend on pubertal stage. Food intake will be measured at 30 and 60 min following a~     glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight)~     or sweetened noncaloric beverage. Subjective appetite will be measured as well.~   "
136183|NCT01272414|"~     Currently there are few therapeutic options for the treatment of lid retraction secondary to~     thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable~     of creating a ptosis, that in the setting of TO can return the upper lid to a more~     physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent~     stage lid position. This investigation aims to examine the properties of this relationship.~   "
136184|NCT01272401|"~     The purpose of this study is to determine how physical activity, other lifestyle factors,~     and psychosocial factors are related to quality of life and other health outcomes across the~     breast cancer survival spectrum from diagnosis to long term survival in a nationally~     representative sample of breast cancer patients and survivors across a 6 month period of~     time.~   "
136185|NCT01272388|"~     Currently, aortic stenosis (AS) is considered a surgical disease with no medical therapy~     available to improve any clinical outcomes, including symptoms, time to surgery, or~     long-term survival. Thus far, randomized studies involving statins have not been promising~     with respect to slowing progressive valve stenosis. Beyond the valve, two common~     consequences of aortic stenosis are hypertrophic remodeling of the left ventricle (LV) and~     pulmonary venous hypertension; each of these has been associated with worse heart failure~     symptoms, increased operative mortality, and worse long-term outcomes. Whether altering LV~     structural abnormalities, improving LV function, and/or reducing pulmonary artery pressures~     with medical therapy would improve clinical outcomes in patients with AS has not been~     tested. Animal models of pressure overload have demonstrated that PDE5 inhibition influences~     NO-cGMP signaling in the LV and favorably impacts LV structure and function, but this has~     not been tested in humans with AS. Studies in humans with left-sided heart failure and~     pulmonary venous hypertension have shown that PDE5 inhibition improves functional capacity~     and quality of life, but patients with AS were not included in those studies. The~     investigators hypothesize that PDE5 inhibition with tadalafil will upregulate NO-cGMP~     signaling, reduce oxidative stress, and have a favorable impact on LV structure and function~     as well as pulmonary artery pressures and quality of life. In this pilot study, the~     investigators anticipate that short-term administration of tadalafil to patients with AS~     will be safe and well-tolerated.~   "
136186|NCT01272375|"~     The purpose of this study is to investigate the time course of PF-04764793 concentration in~     the blood following dosing by oral inhalation from dry powder inhalers.~   "
136187|NCT01272362|"~     In this 5-months study, the response of patients to salbutamol at baseline will be compared~     with their response to treatment with indacaterol.~   "
136188|NCT01272349|"~     The goal of the study is to determine whether repeatedly breathing low oxygen levels for~     brief periods (termed intermittent hypoxia) will improve limb function after spinal cord~     injury. This idea stems from animal studies on respiration, in which investigators have~     shown that mild intermittent hypoxia improves breathing in spinally injured rats. These~     studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural~     connections and motor neuron function within the spinal cord. Exposure to mild intermittent~     hypoxia triggers a cascade of events, including increased production of key proteins and~     increased sensitivity of spinal cord circuitry necessary for improved breathing.~      The ultimate goal of this research is to assess the potential of mild intermittent hypoxia~     as a therapeutic approach to stimulate recovery of limb function in human patients.~   "
136189|NCT01272336|"~     The goal of the study is to examine the effects of repeated breathing episodes of mild~     intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability~     following cervical spinal injury, and to determine whether these changes result in improved~     hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability~     of the nervous system to strengthen neural pathways based on new experiences), which could~     result in improvements in hand use for persons with spinal cord injury (SCI).~   "
136190|NCT01272323|"~     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with~     allergic rhinoconjunctivitis and/or asthma.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who~     completed all dosing visits in study CP005 approximately one year after the start of~     treatment.~   "
136191|NCT01272310|"~     The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose~     combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN~     alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who~     failed to respond following a course of PEG-IFN and RBV Therapy.~   "
136192|NCT01272297|"~     Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED~     patients responding to PDE5i's. This study aimed to determine the capability of swt to~     convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.~   "
136193|NCT01272284|"~     An international, multi-center, single arm, prospective clinical study designed to assess~     the safety and efficacy of the Coloplast Altis single incision sling system for females with~     stress urinary incontinence (SUI).~   "
136194|NCT01272271|"~     This retrospective chart review study compares the incidence of corneal inflammation due to~     infection in children vs. adult patients wearing overnight corneal reshaping lenses.~   "
136195|NCT01272258|"~     PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind,~     placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5~     monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral~     antiretroviral regimen in HIV-infected injection drug users with viral rebound and~     documented poor adherence to the previous antiretroviral regimen.~   "
136196|NCT01272245|"~     The goal of this clinical research study is to learn if omacetaxine given with cytarabine~     can help to control the disease in patients with AML or high-risk MDS. The safety of the~     study drugs will also be studied.~   "
136197|NCT01272232|"~     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).~      The aim of this trial is to investigate the potential of liraglutide to induce and maintain~     weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added~     onto subject's pre-trial background diabetes treatment of either diet and exercise only or~     single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or~     glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The~     duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.~   "
136198|NCT01272219|"~     This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.~      The aim of this clinical trial is to evaluate the potential of liraglutide to induce and~     maintain weight loss over 56 weeks in obese subjects or overweight subjects with~     co-morbidities. Furthermore, the aim is to investigate the long term potential of~     liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at~     baseline.~      Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to~     either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised~     treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to~     subjects with pre-diabetes status at baseline).~   "
136199|NCT01272206|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety and~     pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC~     0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human~     subjects.~   "
136200|NCT01272193|"~     This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and~     safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with~     type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects~     continued at the same dose and dosing frequency.~   "
136201|NCT01272180|"~     This study will evaluate the safety and immunogenicity of combination vaccines as compared~     to the reference vaccines~   "
136202|NCT01272167|"~     Epidemiological studies definitively show that fruit and vegetable consumption is an~     important factor for the prevention of age-related diseases such as cardiovascular diseases~     (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently~     consumed worldwide, essentially as juices.~      Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely~     flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively~     significant source of a specific flavanone called naringin.~   "
136203|NCT01272154|"~     Purpose~      - Objective : Sensorimotor adaptation allows the modification of the motor command taking~     into account the errors detected during execution of prior movements. It involves a large~     cortico-subcortical network. Isolated lesions of this network do not systematically alter~     sensorimotor adaptation except for cerebellar lesions. The cerebellum is thus a key~     structure for sensorimotor adaptation. However, the link between cerebellar and the cortical~     plasticity underlying sensorimotor adaptation remain unknown. Alteration of sensorimotor~     adaptation is associated with dystonia but it is unclear whether it is a cause or~     consequence of dystonia. It has been hypothesized that the abnormal plasticity observed in~     dystonia could account for the associated alteration of sensorimotor adaptation.~      Classically, basal ganglia dysfunction is considered to be crucial for dystonia~     pathogenesis. However, recent studies suggest that the involvement of the cerebellum may~     also be important in this setting. In primary dystonia, imaging studies showed abnormal~     cerebellar activation during sensorimotor adaptation tasks and neurophysiological studies~     demonstrated a decrease of cerebellar output.~      The aim of this study is to investigate the role of the cerebellum in the cortical~     plasticity underlying sensorimotor adaptation both in healthy subjects (normal plasticity)~     and in dystonic patients (abnormal plasticity).~      - Methods: Paired associative stimulation PAS consists in repetitive pairing of a peripheral~     nerve and a cortical stimulation. This kind of stimulation has been designed to induce~     artificial plasticity that can be easily measured. This PAS induced sensorimotor plasticity~     is exacerbated and has lost its topographical specificity in dystonic patients.TMS using~     trains of TMS pulses (rTMS) can be applied on the cerebellum to modulate its output. We will~     test the effect of rTMS induced modulation (cTBS- inhibitory, iTBS-excitatory, sham) of the~     cerebellar output on PAS induced plasticity in patients with dystonia and healthy control.~      We will also assess the acute effect of the rTMS induced modulation of the cerebellar output~     on the dystonic symptoms and on the performance at a validated sensorimotor adaptation task.~     This will be done by double blind post-hoc scoring of the dystonia (BFM or TWSTRS) on~     standardized videorecording and measurement of the performance at the task after each rTMS~     session (cTBS, iTBS, sham).~      Finally, we will assess the variation of PAS effect on other parameters reflecting cortical~     excitability after each rTMS session (cTBS, iTBS, sham).~   "
136204|NCT01272141|"~     The patient is being asked to join this clinical research study to find out if lapatinib, an~     agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface~     of cancer cells in combination with everolimus, an agent that targets a protein in the~     cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple~     negative breast cancers that are no longer controlled by standard chemotherapy.~   "
136205|NCT01272128|"~     The primary objective is to assess the quality of life of intramuscular (IM) Interferon~     Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically~     Isolated Syndrome (CIS) in a clinical practice setting.~   "
136206|NCT01272115|"~     Background: Climacteric stage women experience significant biological, psychological and~     social changes. With demographic changes being observed in the growing number of climacteric~     stage women in Mexico, it is important to improve their knowledge about the climacteric~     stage and its potential associated problems, encourage their participation in screening~     programs, and promote the acquisition of healthy lifestyles.~      At Mexican health care institutions the predominant health care model for climacteric stage~     women has a biomedical perspective. Medical doctors provide mostly curative services and~     have limited support from other health professionals. This study aims to design an~     integrative health care model (IHCM: bio-psycho-social, multidisciplinary and~     women-centered) applicable in primary care services aimed at climacteric stage women.~      Methods: A field trial with one intervention and one comparison group, with ex ante and ex~     post measurements will be conducted in two IMSS primary care clinics in Mexico City. The~     clinics will be selected for convenience; each clinic must have more than 20 family doctors'~     offices and available space for the intervention (consulting room and an area for group~     counseling) and should have accepted to participate in the study; The intervention will be~     conducted in one clinic and the other clinic will serve as a comparison group, where the~     usual care for climacteric stage women will be observed.~      The study population will consist of women affiliated with IMSS, between 45 and 59 years of~     age with a maximum of 5 years after menopause. The women should be users of the clinic, and~     should not have mental conditions that would prevent them from understanding the information~     or from taking independent decisions (dementia, mental retardation or psychosis), a physical~     disability that would impede them from participating (hearing loss, diseases affecting~     physical mobility as severe forms of rheumatoid arthritis), medical diagnosis of depression,~     diabetes mellitus, hypertension, renal or liver failure, and/or cancer, because patients~     with these diseases require specific care provided by several specialists. All women must~     agree to participate in the study through written informed consent.~      The IHCM consists of collaborative and coordinated provision of services by a health team,~     which is involves a family doctor, nurse, psychologist, and the woman herself. The health~     team promotes the empowerment of women through individual and group counseling on the~     climacteric stage and health related self-care. The intervention lasts three months followed~     by a three-month follow-up period to evaluate the effectiveness of the model. The~     effectiveness of the model will be evaluated through the following aspects: health-related~     quality of life (HR-QoL), empowerment, self-efficacy and knowledge regarding the climacteric~     stage and health-related self-care activities, use of screening services, and improvement in~     lifestyles (regular leisure time, physical activity and healthy diet).~      The sample size for the primary outcome (HR-QoL) was estimated by using the formula to test~     change in the mean of two normally distributed samples in longitudinal studies. An average~     increase of at least 10 points in one or more domains of WHQ23 in the intervention group~     compared with control group women was considered to be clinically relevant. The assumptions~     included: a mean HR-QoL score of 64.9 points (standard deviation of 23.4 points) in the~     domain of general well-being, a= 0.05 ( for one-sided hypothesis) and ß = 0.20. The number~     of women by group, assuming a drop-out rate of 20% will be 107.~      We also estimated a sample size for regular leisure time physical activity considering that~     this is the outcome variable more difficult to achieve. It was assumed that only 17% of~     women in Mexico engaged in some type of regular leisure time physical activity and a~     positive increase of at least 10% will be achieved after women participation in the IHCM.~     For this calculation, we used the formula to test the difference of proportions between two~     populations with a= 0.05 (one side) and the power of 80%. The total number of women by group~     to include assuming a drop-out rate of 20% will be 207.~      Discussion: Participation in preventive activities should be encouraged among women in~     Mexico. Designing and evaluating the effectiveness of an integrative health care model for~     women at the climacteric stage, based on the empowerment approach and focus on~     health-related self-care to improve their HR-QoL is pertinent for current health conditions~     of this age group.~   "
136207|NCT01272102|"~     To determine the area under the Receiver Operator Characteristic Curve (AUC) for the~     Ganglion Cell Analysis (GCA) average thickness.~   "
136208|NCT01272089|"~     The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed~     once-daily, in subjects with allergic conjunctivitis and to record any adverse events as~     described by the subjects as a part of this post marketing surveillance study.~   "
136209|NCT01272076|"~     The objective of this study is to compare Cirrus HD-OCT automated measurements of the~     illumination area under the retinal pigment epithelium (RPE) to expert manual measurements~     of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF)~     images.~   "
136210|NCT01272063|"~     The objective of this study is to compare the areas designated as elevated retinal pigment~     epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus~     photographs (CFPs).~   "
136211|NCT01272050|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet~     known which radiation therapy regimen is more effective in treating patients with relapsed~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy~     and comparing two radiation therapy regimens in treating patients with relapsed prostate~     cancer after surgery.~   "
136212|NCT01272037|"~     This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole,~     letrozole, or exemestane with or without chemotherapy work in treating patients with breast~     cancer that has spread from where it began in the breast to surrounding normal tissue~     (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using~     tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor~     cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight~     breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. It is not yet known whether~     giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with~     combination chemotherapy in treating patients with breast cancer.~   "
136213|NCT01272024|"~     1.) To integrate discharge planning into an intervention provided by advanced practice~     nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the~     intervention, and 3.) To explore the reach, adoption, and implementation of the intervention~     to facilitate the transition of patients from surgery/biopsy/chemotherapy to medical~     oncology in a comprehensive cancer center.~   "
136214|NCT01272011|"~     Change to Reflect What Was Done and reason Changes Were Made.~      The purpose of this study is to determine (1) if a specific breathing treatment~     (intermittent hypoxia) can promote changes in breathing function and (2) if pairing~     breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking~     recovery observed with locomotor training alone (without breathing treatments).~   "
136215|NCT01271998|"~     The primary purpose of this study is to determine the steady-state plasma pharmacokinetics~     (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar~     macrophages (AM) of healthy volunteers.~   "
136216|NCT01271985|"~     The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose~     combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and~     secondary prevention of cardiovascular disease in Iranian adults older than 50.~   "
136217|NCT01271972|"~     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/~     SAR307746) administered IV every 2 weeks.~   "
136218|NCT01271959|"~     The purpose of this research study is to collect information from patient's medical records~     that had a test called ChemoFx® ordered and to understand how doctors may have used the~     results of the ChemoFx® to treat patients with cancer.~   "
136219|NCT01271946|"~     The goal of this study is to observe the clinical safety and effectiveness of the~     ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through~     the femoral artery.~   "
136220|NCT01271933|"~     The purpose of this study is to evaluate the efficacy and safety of a controlled release~     formulation of pregabalin administered once daily as compared to placebo in the treatment of~     fibromyalgia. All patients will receive pregabalin; half of the patients will receive~     placebo at some point in the study.~   "
136221|NCT01271920|"~     The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab~     in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is~     defined as the highest drug dosage not causing in the first cycle of treatment (28 days)~     medically unacceptable dose limiting toxicity (DLT).~      The phase II part of the trial will assess any potential effect on efficacy of adding AUY922~     to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+~     breast cancer.~      Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should~     be continued as long as the patient does not have disease progression and tolerates the~     treatment. The following reasons are examples of acceptable reasons for discontinuing the~     study; tumor progression (by RECIST, as assessed by the investigator), unacceptable~     toxicity, death, or discontinuation from the study for any other reason, such as patient~     refusal, withdrawn consent, lost to follow-up or investigator decision.~   "
136256|NCT01271465|"~     The purpose of this study is to see if substances measured in a small piece of the donor~     organ predicts how well the organ will function in the recipient after transplant. We will~     be testing blood, urine, and biopsy tissue samples in this study. The research team will be~     looking at different risk factors in the donor organ that predict how well the kidney will~     do in the recipient.~   "
136222|NCT01271907|"~     Background:~        -  Recent cancer treatment studies have shown that altering a cancer patient's own white~          blood cells may help the immune system fight the cancer. In all of these studies,~          participants donate their own white blood cells through a procedure called~          leukapheresis, and the cells are altered in the laboratory and given back to the~          participants. After the cells are given, the patients receive aldesleukin (IL-2) to~          help the tumor fighting cells stay alive longer. For individuals with metastatic~          melanoma, pieces of melanoma proteins may be added to the collected white blood cells~          to help the immune system recognize and attack the cancer cells.~        -  Researchers are interested in testing a new process in which cells from fruit flies~          (Drosophila) are used to help the melanoma proteins attach to the white blood cells.~          The fruit fly cells die off shortly after the proteins are introduced to the white~          blood cells. Researchers are also interested in determining whether IL-2 treatment is~          necessary after this new cancer treatment process.~      Objectives:~        -  To test the safety and effectiveness of modified white blood cells~          (Drosophila-generated CTL) as a treatment for metastatic melanoma that has not~          responded to standard treatments.~        -  To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated~          cytolytic T lymphocytes (CTL).~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that~     has not responded to previous IL-2 treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history, tumor~          imaging studies, and heart and lung function tests.~        -  Prior to treatment, participants will have an intravenous catheter inserted into the~          chest to administer the study drugs.~        -  Participants will have leukapheresis to provide white blood cells for laboratory~          modification.~        -  Seven days before the start of the treatment, participants will be admitted to the~          hospital to have chemotherapy with cyclophosphamide and fludarabine. These drugs will~          suppress the immune system to improve the effects of the treatment.~        -  One to four days after the last dose of chemotherapy, participants will receive the~          modified cells. Participants in the group that will receive IL-2 will begin to receive~          the treatment 24 hours after the cell infusion, every day for 5 days. All participants~          will receive filgrastim injections to help the body produce more white blood cells.~        -  Participants will recover in the hospital for about 7 to 12 days after the cell~          infusion or the last dose of IL-2. Participants will continue to receive medications~          and provide blood and tumor samples for testing.~        -  Participants will have regular followup visits to assess the effects of the treatment.~   "
136223|NCT01271894|"~     Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz~     (EFV) is an important component of combination ART in treatment naive individuals. Like many~     drugs, there are inter-individual differences in the efficacy and tolerability of EFV. The~     Encore1 study provides an opportunity to examine the pharmacokinetics (PK)(processes by~     which a drug is absorbed, distributed, metabolized, and eliminated by the body) of EFV in~     blood samples collected over a 24-hour dosing interval in participants receiving either~     standard 600 mg or reduced 400 mg dose EFV once daily.~   "
136224|NCT01271881|"~     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two~     areas of particular problems are the terminal portion of the cephalic vein near the shoulder~     and the central veins in the chest. Although angioplasty is standard of care the treated~     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your~     dialysis access functional. Recently there has been introduction of a new technology called~     a covered stent graft. Initial studies suggest that placing this device across the area of~     narrowing leads to dialysis access staying open longer and needing less angioplasty~     treatments.~      This study is designed to compare angioplasty (standard of care) versus using a covered~     stent graft. The investigators will then look at the dialysis records and future~     fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months~     after the initial procedure.~   "
136225|NCT01271868|"~     The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects~     associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding~     and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric~     subjects with hemophilia B.~   "
136226|NCT01271855|"~     Hypothesis:~      The routine use of belladonna/opium (B&O) suppositories will improve patient's self-reported~     pain control in the first 24-hours after delivery.~      Commonly employed methods of controlling post-partum pain include opioid analgesics,~     non-steroidal anti-inflammatories, acetomenophen, and topical analgesics. Pain medication is~     generally administered via oral or IV route. Several studies have investigated suppositories~     as an alternative method of improving pain following delivery.~      Rectal analgesia provides a means of improving pain control through local effects on the~     perineum and uterus while possibly decreasing systemic absorption, which may in turn~     decrease systemic side effects and transmission to the newborn infant through breast milk.~     B&O suppositories contain two medications that could potentially decrease post-partum pain.~     This quality may significantly improve pain from uterine contractions during the post-partum~     period.~   "
136227|NCT01271842|"~     Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia~     and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation.~     To date, no data exist on the outcome of patients having developed acute respiratory~     distress syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with~     very severe lung injury requiring extracorporeal oxygenation. Although data exist on~     long-term outcome of survivors of ARDS, the patients included in the observational studies~     were heterogeneous with various underlying disease. Moreover, no study compared the outcome~     of survivors of ARDS according to the need or not of extracorporeal oxygenation. We~     therefore conducted this prospective case-control study to compare the long term pulmonary~     and extra pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1~     requiring extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but~     without need for extracorporeal oxygenation (control). Eighteen case patients with inclusion~     and without non-inclusion criteria were selected from our national registry, and 32 controls~     (with inclusion and exclusion criteria) were matched on age, sex, and body mass index. All~     48 patients will be contacted and asked to participate. Patients will be evaluate at least 9~     months after ICU discharge, looking for health-related quality of life, measured by the~     Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic~     stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by~     the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a~     static bike will be performed. Muscle weakness will be clinically evaluated by the medical~     council research (MRC) test, with an additional electromyography if the result of the test~     was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...).~     Albumin and prealbumin will be measured to evaluate the nutritional status.~      Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is~     that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity~     lower than patients without extracorporeal oxygenation (15% difference between groups).~     Inclusion of 13 patients in the case group and 26 patients in the control group will allow~     testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary~     outcome measures will be the quality of life, the presence or not of post-traumatic stress~     disorders, of anxiety and/or depression, the results of pulmonary function testing, of the~     CT-scan, and of muscle testing. All results will be compared in patients with and without~     extracorporeal oxygenation.~   "
136228|NCT01271829|"~     The purpose of this study is to examine the effect of incorporating avocados in meals on~     post-ingestion glycemic index, insulin response, sensations of satiety and on~     appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming~     avocado containing meals on the caloric intake of participants in subsequent eating episodes~     will be explored.~      Each subject will participate in one intervention for one day, wait one or two weeks, come~     for another intervention, wait one or two weeks and come for a final intervention- three in~     total. Participants will be randomly assigned to one of six treatment sequences.~     Postprandial response to the control and two avocado-containing test meals will be assessed~     and compared using a 3 x 3 single blind cross-over design. The Subjects will be between 25~     and 60 years old, female or male, with a BMI of 23 to 32, stable weight, no sports~     involvement, non-smoking and not dependent on caffeine. Thirty subjects will be recruited.~   "
136257|NCT01271452|"~     This study will evaluate the safety and efficacy of two different types of botulinum toxin~     type A for the treatment of glabellar frown lines.~   "
136229|NCT01271816|"~     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition~     characterized by life threatening heart racing, presenting with palpitations, cardiac arrest~     (collapse requiring an ambulance) or sudden death. The disease affects the right ventricle,~     the part of the heart that pumps blood to the lungs. ARVC is diagnosed with a wide range of~     tests that focus on the pumping function and the electrical signals from the right~     ventricle. These factors are summarized in a score that forms the ARVC Task Force Criteria.~     Genetic testing has identified 5 different genes that lead to ARVC, which are detected in~     about 60% of patients with ARVC. This allows doctors to test family members of the patient~     with ARVC to determine if they are at risk of developing the condition. Currently, family~     members undergo testing that includes imaging and electrical tests such as a 24-hour monitor~     to determine if they have evidence of ARVC. With increasing frequency, family members are~     found to have the gene that may lead to ARVC, but little or no evidence that their hearts~     are affected. This may be because the family member is too young to develop the condition,~     or that other factors that we do not understand have protected them from developing it.~      The PREPARE study will study 100 patients that carry a gene that can lead to ARVC, but do~     not have anything more than minor evidence that the condition is present. These patients~     will not have heart racing on their initial 24-hour monitor. These patients will undergo~     long term monitoring with an implanted heart monitor that is inserted with a minor surgical~     procedure, which will detect abnormal heart rhythms that may provide a clue that heart~     racing from ARVC is present that is not detected with a 24-hour monitor that is performed on~     an annual basis (St. Jude Confirm implantable loop recorder). These patients will be~     enrolled in 10 adult and pediatric centers across Canada, and followed for 3 years after~     their heart monitor is implanted. If heart racing is detected, patients will discuss these~     results with their doctor to discuss what it means to them.~   "
136230|NCT01271803|"~     This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will~     evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600~     mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E~     mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have~     progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are~     eligible. Participants will be assigned to different cohorts with escalating oral doses of~     vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage~     [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until~     disease progression, unacceptable toxicity or any other discontinuation criterion is met.~   "
136231|NCT01271790|"~     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug~     regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without~     Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).~   "
136232|NCT01271777|"~     The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at~     80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be~     made using a glucose clamp technique.~   "
136233|NCT01271764|"~     Tumor invasion and metastasis are the major causes of cancer-related death. Some studies~     have found that histone methyltransferases, such as EZH2, specifically affect metastasis in~     breast, gastric and prostate cancer. The functional roles of other members of the HMT family~     such as G9a in cancer remain obscure. Therefore, the investigators will investigate whether~     G9a have a role in recurrence/metastasis of endometrial cancer.~   "
136234|NCT01271751|"~     The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum~     Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels~     compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to~     assess the tolerability and safety of once-a-day administrations of oral doses of GFT505~     during 28 days.~   "
136235|NCT01271738|"~     The goal of this study is to compare two different types of breast surgery. In the first~     type, the doctor removes only the tumor. In the second type, the doctor removes the tumor~     and some of the tissue around the tumor called margins. The amount of breast tissue removed~     is similar. The removal of the tumor only has up to 40% chance of reoperation because the~     tumor is too close to the margin. The primary goal of this study is to see if the additional~     margins can decrease the need to return to the operating room. Both types of surgery are~     well accepted, and participating in the study would not give you a better chance to cure the~     cancer. At present, most breast surgeons remove the tumor without the additional margins.~     For all patients who have this operation, there is a high incidence of return to the~     operating room for margins re-excision: as many as 40% as patients can have a re-operation.~      At present, we do not know if taking the additional margins prevents the cancer from~     returning in the breast or not. If the cancer comes back in your breast, this is a~     recurrence and your breast will have to be removed (mastectomy).~   "
136236|NCT01271725|"~     The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW~     2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who~     progress on afatinib monotherapy within this trial) as treatment in patients with~     HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the~     neoadjuvant or adjuvant setting~   "
136237|NCT01271712|"~     A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best~     supportive care versus placebo plus best supportive care for subjects with metastatic and/or~     unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite~     prior treatment with at least imatinib and sunitinib.~      The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival~     Follow up Period.~      Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of~     every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive~     best supportive care which excludes any disease specific anti cancer therapy such as any~     kinase inhibitor, chemotherapy, radiation therapy, or surgery.~      Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3~     months (through month 6), and every 8 weeks until the end of treatment, or more frequently~     if clinically indicated. Tumor assessments include CT or MRI and will be performed until~     tumor progression is seen in a central radiology review.~      Subjects receiving placebo who experience disease progression may be offered active~     treatment.~      Subjects who experience progression during regorafenib treatment may continue open label~     treatment.~      All subjects will enter the Survival Follow-up Period upon discontinuation of randomized~     study treatment.~   "
136258|NCT01271439|"~     This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to~     evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant~     chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the~     relationship between patient outcome and EGFR gene copy number, expression and mutation.~   "
136259|NCT01271426|"~     To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2~     (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal~     vasculopathy (PCV) with ranibizumab.~   "
136238|NCT01271699|"~     The association of Multiple Sclerosis (MS) and Fabry disease is known from own clinical~     experiences as well as from case reports in the literature, where symptoms and suspicious~     results in the brain MRI led to the misdiagnosis of Fabry patients as MS. Remarkably, those~     patients almost never showed oligoclonal bands or an intrathecally derived IgG-production~     was wrongly assumed due to misinterpretation of CSF results. Where oligoclonal bands were~     present, concomitant diagnoses had to be discussed. Furthermore, those patients showed no~     involvement of the spinal cord, as evidenced by MRI. Beside the possible complications of a~     not-effective and not-necessary MS therapy, those patients are at risk of irreparable organ~     damage due to the delayed implementation of enzyme replacement therapy for Fabry disease.~   "
136239|NCT01271686|"~     This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily~     in patients with glaucoma or ocular hypertension~   "
136240|NCT01271673|"~     Breast cancer is the most common cancer among women residing in majority of the urban areas~     in India. The deaths due to breast cancer are mainly a result of late presentation of the~     symptoms due to lack of awareness of the signs and symptoms of the disease and lack of~     knowledge of performing BSE. The BSE technique can be a good tool for improving the~     awareness about the symptoms of breast cancer. Hence, we propose a pilot study of short~     duration (3 months follow-up), to assess the level of compliance to BSE and assess the~     various reasons for non-compliance. Based on the results of this study a long term cohort~     study will be planned with similar objectives.~   "
136241|NCT01271660|"~     Muscle cramp is defined as a paroxysmal, involuntary, and painful contraction of skeletal~     muscle. Cirrhotic patients can encounter with muscle cramp frequently, which might be~     associated with poor quality of life. Gabapentin can be prescribed for muscle cramp.~     However, patients with liver cirrhosis have limited access to gabapentin which is~     metabolized primarily in liver.~      Pregabalin with a similar mechanism of action to gabapentin undergoes negligible metabolism~     owing to its improved pharmacokinetic properties. Thus, pregabalin might be a promising~     therapeutic option for patients with liver cirrhosis who are suffering from muscle cramp and~     susceptible to drug-induced hepatotoxicity.~      Therefore, the investigators hypothesize that pregabalin could effectively reduce painful~     symptoms derived from muscle cramp. In the current study, the investigators are going to~     evaluate the efficacy and safety of pregabalin by comparing outcomes between two groups~     (treatment group vs. placebo group).~   "
136242|NCT01271647|"~     The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang~     tonic formula for osteopenia and to research the mechanism of efficacy.~   "
136243|NCT01271634|"~     The pathophysiologic basis of hemifacial spasm is cross-transmission between different~     branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by~     the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential~     from the offending vessel to the facial muscles will be detected on hemifacial spasm~     patients, so as to determine if the sympathetic nerve fibers take part in the circuit of~     cross-transmission.~   "
136244|NCT01271621|"~     Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in~     intraocular pressure along with tachycardia and hypertension. These effects are not~     desirable in ophthalmic patients especially in patients with glaucoma. GlideScope video~     laryngoscope system is a new approach for laryngoscopy and tracheal intubation. It does not~     require a direct line of sight to the glottis when intubating with the Glidescope and as a~     result intubation is much less stimulating to the patient. Therefore GlideScope video~     laryngoscope assisted intubation could be a preferable technique for intraocular surgery~     offering advantages in terms of intraocular pressure and cardiovascular stability.~   "
136245|NCT01271608|"~     Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous~     injection between a retractable fixed syringe needle and the technique involving needle~     exchange; Comparing bruise formation following administration of insulin subcutaneous~     injections between RFS and the conventional technique.~      Method Study site A clinical trial was conducted in two medical-surgical units in a hospital~     in the period from June 15th to November 30th, 2009, after approval by the Ethics and~     Research Committee.~      Intervention In a group of patients the investigators used syringes with retractable fixed~     needle to administer subcutaneous and intramuscular injections. In the group of control, the~     investigators used the standard technique to administer medications.~      Population of study Patients were sequentially enrolled through a lottery system of exposure~     using random numbers kept in sealed, opaque envelopes.~      Sampling design and sample size Subcutaneous injection The sample size was based on the~     expected proportion of bruising following the injection. It was expected that 40% of~     patients would show bruising with the conventional technique and 20% with the technique~     under study for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of~     study of 80% (beta error of 20% or 0.2) 240 patients were included, 120 in each group.~      Intramuscular injection The sample size was based on the proportion of patients with~     moderate to severe pain. It was considered normal the incidence of moderate to severe pain~     in 30% with a needle exchange, whereas it was considered an increase of up to 40% with the~     retractable fixed needle. The investigators included 500 patients in each group.~   "
136246|NCT01271595|"~     There is inconclusive evidence whether acupuncture treatment is effective in the treatment~     of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture~     in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of~     acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the~     DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of~     acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to~     investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic~     function in a sub-group of ACUSAR patients. Baseline values were compared to data from~     matched healthy controls.~   "
136247|NCT01271582|"~     The purpose of this study is to investigate the association between UGT1A1 polymorphisms and~     neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer~     treated with FOLFIRI regimen.~   "
136248|NCT01271569|"~     The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of~     Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by~     electroencephalogramderived assessment (Bispectral Index [BIS]) and to compare the dynamic~     properties of PropofolF to those of Propofol.~   "
136249|NCT01271556|"~     The cardiovascular component associated with COPD plays a major role in prognosis of the~     disease, being responsible of 25% of the deaths. Experimental and initial clinical data~     suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar~     airspace, with potential positive effect on cardiogenic pulmonary edema.~      The aim of this study was to investigate the effects of a long-acting beta-2 agonist,~     salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and~     mechanical lung properties. Our experimental model to test alveolar fluid clearance was~     rapid saline intravenous infusion.~      Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin~     of the study were evaluated, in four non consecutive days, just before and after a saline~     infusion or a similar period without infusion.~      Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol~     premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol~     pretreatment lead to a significant reduction of the impairment of gas exchange due to saline~     infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the~     changes in FEV1. In the control setting, with no infusion, we did not find any significant~     change of both DLCO and mechanical properties of the lung.~      In conclusions, in COPD patients salmeterol appears to provide a protective effect against~     an acute alveolar fluid clereance challenge secondary to lung fluid overload providing an~     intriguing mechanistic explanation for the benefits observed in larger trials.~   "
136250|NCT01271543|"~     Because of its simplicity of function and reliability, direct laryngoscopy it is routinely~     used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is~     fraught with concerns for cardiovascular stimulation during induction of general anesthesia.~     This can be attributed to the placement of the laryngoscope blade into the vallecula and~     then applying force in an upward direction to expose the glottic opening. The average force~     necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to~     significant pressor responses and tachycardia though stimuli to supraglottic region.~      An alternative airway management device is the Shikani optical stylet (SOS). It is an~     effective, safe and reusable intubation device that has been shown to be effective in cases~     of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable~     stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment~     to a light source. An adjustable tube stop firmly affixes the endotracheal tube to the~     stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the~     stylet with the loaded endotracheal tube into the patient's oropharynx and under direct~     visualization through the eyepiece, is able to visualize the vocal cords. Because the end of~     the stylet is at the end of the endotracheal tube, it can be directly visualized to be~     entering trachea past the vocal cords.~      The investigators hypothesize that endotracheal intubation performed by the aid of SOS by~     minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in~     patients with normal airways as compared with the MacIntosh laryngoscope.~   "
136251|NCT01271530|"~     The aim of this study is to investigate the effect of upper limb cardiovascular training on~     fitness, energy cost of walking, fatigue and pain in polio survivors. Polio survivors often~     have difficulty accessing aerobic forms of exercise due to limitations in mobility, pain~     associated with walking and fatigue. This can result in becoming physically unfit and places~     polio survivors at risk of secondary heath problems due to inactivity. A large percentage of~     polio survivors have lower limb involvement but have strong arms. The participants in this~     study will exercise at home using simple arm cycles for 8 weeks. They will attend for~     assessment on two occasions. All exercise will be prescribed by a Physiotherapist and~     includes measures to ensure safety while exercising at home.~   "
136252|NCT01271517|"~     Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve~     glycemic control during the first year of treatment of children/adolescents with type 1~     diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal~     balance of the GH-IGF-axis.~      This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age,~     newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting~     basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of~     treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH~     insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin~     aspart). The investigators will explore possible mechanisms of action by determining~     remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators~     will also assess changes in body composition and evaluate quality of life in each treatment~     arm.~   "
136253|NCT01271504|"~     The purpose of this study is to determine whether patients with hepatocellular carcinoma who~     receive either E7050 administered with Sorafenib or Sorafenib alone experience greater~     benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.~   "
136254|NCT01271491|"~     Bronchiolitis is a potentially severe infection of the airway in infants and children, and~     among the most frequent diagnoses leading to pediatric intensive care unit admission in~     infants. This acute infection is caused by an array of viruses, but respiratory syncytial~     virus (RSV) is the most frequently implicated. The majority of infants hospitalized with~     bronchiolitis are previously healthy, and half of infants intubated and mechanically~     ventilated for respiratory failure due to RSV bronchiolitis have no previously identified~     risk factors. It is likely, therefore, that other factors, particularly genetic~     heterogeneity of the host, contribute to disease severity. However, no previous study has~     investigated the association of genetic variants with respiratory failure in children with~     bronchiolitis. Several categories of candidate genes have emerged as potentially important~     in the pathogenesis of the disease. Specifically, genetic polymorphisms of surfactants,~     pattern recognition receptors, receptor adhesion molecules, and cytokines have been~     examined. The aim is to evaluate these polymorphisms to determine their association with~     respiratory failure in a cohort of more severely ill children with bronchiolitis.~   "
136255|NCT01271478|"~     The aim of this study was to compare the dual use of telmisartan and captopril vs the~     individual use of such drugs and placebo on the systemic inflammation of patients on~     hemodialysis (HD).~   "
136263|NCT01271374|"~     The purpose of the study is to compare the effects of Azor (a combination of amlodipine and~     olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin~     lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood~     pressure normal.~   "
136264|NCT01271361|"~     The purpose of the study it to evaluate whether primary percutaneous coronary intervention~     (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy~     increases minimal flow area after stenting for treatment of patients presenting with~     ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.~   "
136265|NCT01271348|"~     Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric~     contractions~   "
136266|NCT01271335|"~     A prospective, three-center, phase I safety and tolerability dose escalation study,~     evaluating 28 subjects in 4 discrete dose cohorts of acute intracoronary injected~     collagenase ranging from 300 - 1200 µg prior to routine standard-of-care percutaneous~     revascularization procedures in subjects with chronic total coronary artery occlusions~     (CTOs).~   "
136267|NCT01271322|"~     Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of~     PET as a predictor of histopathological response in metabolic non-responders Patients with~     resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or~     cN+ and cM0)~      Metabolic non-responders, showing a <35% decrease of SUV (standardized uptake value) two~     weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken~     to intensified taxane-based RCT (radiochemotherapy) before surgery. 18FDG-PET scans will be~     performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after~     the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified~     radiochemotherapy (PET2).~      Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV).~     The percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated~     and assessed as an early predictor of histopathological response. In a secondary analysis,~     the association between the difference SUVPET1 - SUVPET2 and histopathological response will~     be evaluated.~   "
136268|NCT01271309|"~     The present project aims to determine whether a deficit in migration of stem cells could be~     implicated in the failure to mount an adequate collateralization after Myocardial Infarction~     (MI) and thereby facilitate the development of post-ischemic heart failure (HF) and to~     dissect underlying molecular mechanisms. Furthermore, the investigators wish to determine~     the predictive value of stem cell migration assay in patients with MI.~   "
136269|NCT01271296|"~     Addison's disease is a rare disease, wherein the adrenals can not produce sufficient steroid~     hormones (cortisol and aldosterone). Patients with Addison's disease report impaired~     subjective health status, and they have increased all-cause mortality. Conventional therapy~     is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy~     imperfectly mimic the diurnal cortisol variations, and render the patients both over- and~     under-treated. Anecdotally, some patients with adrenal insufficiency may benefit from the~     use of various nutritional compounds. We hypothesised that liquorice and grapefruit altered~     the metabolism and absorption of cortisone acetate.~   "
136270|NCT01271283|"~     This phase II clinical trial is studying how well lenalidomide works in treating patients~     with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may~     stimulate the immune system in different ways and stop cancer cells from growing.~   "
136271|NCT01271270|"~     Background:~        -  Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in~          the back of the eye, and leak blood and other fluids that damage the eye, produce~          scarring, and lead to blindness. People diagnosed with wet AMD have increased~          production of a body chemical called vascular endothelial growth factor (VEGF). VEGF is~          important in the formation of blood vessels in the body, and decreasing the production~          of VEGF is believed to help wet AMD patients by preventing or slowing the growth of the~          abnormal blood vessels. Anti-VEGF drugs have been used to decrease the production of~          VEGF, but some people do not respond completely to these drugs.~        -  A protein in the body called mTOR also plays a critical role in regulating how cells~          divide and grow and obtain their blood supply. The experimental chemical Palomid 529~          inhibits the production of mTOR. Researchers are interested in determining whether~          Palomid 529 is safe and can help individuals with wet AMD who have not completely~          responded to anti-VEGF treatments.~      Objectives:~      - To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related~     macular degeneration in individuals who have not responded to standard anti-VEGF treatments.~      Eligibility:~      - Individuals with wet age-related macular degeneration in at least one eye that has not~     responded to standard anti-VEGF treatments.~      Design:~        -  Prior to the first visit, participants should have been seen at the National Eye~          Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103,~          High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal~          Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be~          designated as the study eye to receive the Palomid 529 treatment.~        -  Participants will have a full physical examination and medical history, a full eye~          examination to evaluate eye health and vision, angiography to examine the blood vessels~          in the eyes, and blood and urine tests during the study~        -  Participants will receive an injection of Palomid 529 into the study eye every 4 weeks~          during the study, for a total of three injections. Participants may also receive~          anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the~          study eye 12 days before and 12 days after the Palomid 529 injection.~        -  Participants may have standard-of-care treatments for the non-study eye if it has wet~          AMD as well, but may not receive experimental treatments in the non-study eye while~          they are in this study.~        -  Participants will return for long-term follow-up examinations as directed by the study~          researchers.~   "
136272|NCT01271257|"~     The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional~     oral misoprostol.~   "
136273|NCT01271244|"~     The study looked at relationship between escitalopram and heart rate variability and QT~     variability in veterans with PTSD.~   "
136274|NCT01271231|"~     Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes~     a cascade of systemic alterations that may lead to kidney failure, cardiovascular~     complications, altered tissue healing, retinopathies and gangrene. Diabetes is also~     associated to increased susceptibility to infections and inflammation.~      It has been observed that diabetic patients suffer more often from oral infections such as~     periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to~     destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms~     responsible for systemic complication are implicated in the development of periodontal~     disease. This has been evaluated in studies where diabetic patients showed increased levels~     of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has~     also been suggested that established periodontitis in the diabetic patient leads to insulin~     resistance due to infection and liberation of cytokines from periodontal tissues and thus~     worsening the diabetic condition.~      This study is aimed to establish the response to periodontal treatment with antibiotics and~     the kinetics of glucose levels in diabetic patients.~   "
136284|NCT01271101|"~     The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of~     Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in~     China, and the resources used for it.~   "
136524|NCT01267981|"~     The best preparation of small bowel is still unknown. The primary aim of this study is to~     evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained~     gastrointestinal bleeding exploration. Three different preparations are evaluated in this~     study.~   "
136275|NCT01271218|"~     Background: Exercise, weight loss, and dietary supplementation of glucosamine and~     chondroitin (GC) have been reported to improve functional capacity in individuals with knee~     osteoarthritis (OA). The purpose of this study was 1.) to determine whether women with knee~     OA who follow a higher protein diet observe more favorable changes in body composition~     and/or markers of health compared to those following a standard higher carbohydrate-based~     diet; and, 2.) to determine whether dietary supplementation of glucosamine and chondroitin~     during a weight loss and fitness program lessens symptoms of pain, improves functional~     capacity, and/or promotes greater health benefits in women with knee OA. It was hypothesized~     that both groups would experience beneficial changes in body mass, body composition, and~     markers of health. However, greater benefits would be observed in those following a higher~     protein diet while supplementing the diet with glucosamine and chondroitin.~   "
136276|NCT01271205|"~     Abstract Pneumonia is a leading cause of severe morbidity and mortality among adults. During~     the last two decades, several scores were developed to evaluate the probability of morbidity~     and mortality among patients with community acquired pneumonia (CAP), such as the PORT score~     and the CURB65. Recently, several studies showed that elevated Red Cell Distribution Width~     (RDW) could be used as a prognostic tool for predicting severe morbidity and mortality among~     patients with cardiac diseases.~      RDW is a quantitative measure for red blood cell (RBC) size variability. Recent studies have~     suggested that high levels of RDW are in association with higher mortality among~     cardiovascular patients.~      RDW has not yet been studied as a prognostic sign in CAP. The goal of this study is to~     examine the role of RDW as a prognostic factor for severe morbidity and mortality among~     patients who were hospitalized with CAP , independently to Hemoglobin levels, renal function~     and inflammatory markers.~   "
136277|NCT01271192|"~     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for~     resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant~     therapy is still unknown.~      PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed~     by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and~     postoperative chemotherapy, comparing them to see the efficacy and safety, then to~     investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal~     cancer.~   "
136278|NCT01271179|"~     The study was designed to investigate whether, compared with conventional sole perfusion~     with high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver~     grafts with low-viscosity and high-viscosity preservation solutions could further decrease~     the incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.~   "
136279|NCT01271166|"~     This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of~     Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level~     in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to~     the toxicities observed. Once the MTD has been determined the dose level below will be~     re-opened and extra patients, to a total of 15, will be enrolled.~   "
136280|NCT01271153|"~     The investigators hypothesize that dobutamine is able to revert negative redistribution of~     flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly~     at the sublingual and gastric mucosa, and at the peripheral tissues.~      The investigators designed a randomized, cross-over, placebo-controlled study looking at the~     acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function,~     microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic~     shock patients.~   "
136281|NCT01271140|"~     Insulin resistance is one of the key factors in defining a progressive course of chronic~     Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted~     insulin resistance as an adjuvant way to manage hepatitis C liver disease with promising~     results.~      Long term therapy using high dose insulin was shown to significantly reduce insulin~     resistance in obese patients. In cardiac and critically ill patients, long term insulin was~     shown to produce better outcomes mainly by reducing the overt inflammatory response.~     Furthermore, initial results of ongoing trials are revealing more benefits of insulin~     therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients~     undergoing major liver resection was able to maximize their liver function post-operatively.~     This trial also demonstrated inhibition of the inflammatory response, improvement in liver~     glycogen, inhibition of apoptosis and stimulation of liver regeneration.~      Putting in mind the potential ability of the liver to regenerate and regain better function.~     The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin~     resistance over time has led us to see the potential benefits of using insulin therapy on~     patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the~     pathophysiology of the disease at a cellular and a molecular level.~      The investigators theorize that long-term high insulin therapy would be able to promote~     better liver function and slow down fibrosis and injury in this population of patients.~   "
136282|NCT01271127|"~     Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late~     treatment sequelae such as cardiovascular events due to coronary artery disease. At present~     no active screening is performed in these patients since it is not known whether screening~     and subsequent treatment by means of revascularization is effective in reducing the risk of~     cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic~     consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among~     asymptomatic HL survivors will be evaluated.~   "
136283|NCT01271114|"~     In hypotensive septic patients with controlled source, an hemodynamic management protocol~     including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction)~     Score by at least 3 points compared to the use of physiologic saline and norepinephrine.~      The appropriate design for this trial would be factorial. For the time being, will consider~     de intervention as a whole unit for this pilot study. In the future an appropriately sized~     factorial multicentric study shall be necessary.~      Other goals of the pilot study:~        1. HS restores preload parameters adequately~        2. HS associated with terlipressin normalizes blood pressure in septic shock~        3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L~        4. There is an inverse relationship between plasma sodium and procalcitonin levels~        5. HS increases plasma levels of vasopressin (AVP)~        6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)~   "
136285|NCT01271088|"~     Peritonitis is currently one of the leading complications of continuous ambulatory~     peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD~     peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the~     treatment and prophylaxis of many diseases related to oxidative stress. The aim of this~     study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD~     peritonitis can be prevented by N-acetylcysteine~   "
136286|NCT01271075|"~     This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy,~     mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold~     contact urticaria (CCU).~      Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT)~     and critical temperature thresholds (CTT) after treatment with different dosages of~     bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are~     randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg,~     placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time.~     In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed~     by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6~     visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3~     and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7,~     day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will~     be enrolled.~   "
136287|NCT01271062|"~     Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of~     improvement of pathological beta cell function. The presented double-centre study aims to~     comprehensively investigate different aspects of beta cell function in patients with type 2~     diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our~     project will address the aspects of changes in enteroinsular and adipoinsular axes as well~     as the early and late changes of other defined parameters after gastric bypass surgery.~   "
136288|NCT01271049|"~     The prevalence of intestinal helminths is worldwide. This study will evaluate the~     tolerability of a novel food product consumed by adults residing in an area endemic for~     helminths.~   "
136289|NCT01271036|"~     This is a one week study designed to test the safety of a personal lubricant during in-home~     use for subjects who perceive themselves as having sensitive skin.~   "
136290|NCT01271023|"~     The purpose of this study is to test an insulin management system (Control-to-Range (CTR)~     system) in an inpatient setting to see if the system is safe and effective enough to test~     in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose~     Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines~     how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the~     insulin.~      The study will include two hospital stays consisting of meals and exercise scenarios. Both~     hospital stays will be for 24+ hours during the day and night. The study will include about~     50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.~   "
136291|NCT01271010|"~     This multi-center, single-arm study will evaluate the efficacy and safety of rituximab in~     combination with fludarabine and cyclophosphamide in participants with B-cell chronic~     lymphocytic leukemia (CLL) and favorable somatic status.~   "
136292|NCT01270997|"~     The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in~     combination with Methotrexate in patients with rheumatoid arthritis.~   "
136293|NCT01270984|"~     The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic~     characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when~     administered a single-dose to healthy volunteers.~   "
136294|NCT01270971|"~     The purpose of this study is to determine whether AN2690 topical solution is a safe and~     effective treatment for onychomycosis of the toenail.~   "
136295|NCT01270958|"~     Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs~     following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and~     occurs all year around. It's caused by allergy to the aerosolised droppings of house dust~     mites and pet skin flakes (dander). Occasionally, indoor mould spores and, in rare cases,~     food allergy can be causes.~      Intranasal corticosteroids are highly effective medications for controlling the nasal~     symptoms that accompany allergic rhinitis.~      AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects~     on nasal symptoms of seasonal and perennial allergic rhinitis and on the ocular symptoms of~     allergic rhinitis and has been evaluated as effective and safe for treatment seasonal and~     perennial allergic rhinitis by FDA. It is speculated that AVAMYS (TM) is also effective and~     safe for Vietnamese patients. However before being used widely for patients across the~     country, AVAMYS (TM) should be proved that it is safe for Vietnamese patients.~      The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal~     spray 110mcg once daily in adults with PAR.~      This is a 6-week, open trial. A study center will be enlisted to recruit a minimum of 50 PAR~     subjects.~      At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in~     the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray~     110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the~     device into each nostril once daily every morning. Administration of the dose will be~     performed by alternately spraying one spray to each nostril followed by a second spray to~     each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication~     during the screening or treatment period.~      Throughout the study, subjects will document their study drug administration/compliance, any~     medical conditions experienced, and any concomitant medications taken. All subjects are~     outpatients.~      The safety assessments include a summary of the frequency and type of clinical adverse~     events that occur during the study. In addition, hematology and chemistry analyses of blood~     samples are also implemented. A physical examination and nasal examination are also~     performed and vital signs collected. Twelve-lead ECGs are performed at all visits.~   "
136296|NCT01270945|"~     The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or~     the time to restenosis in patients undergoing repeat peripheral artery revascularization~     versus controls randomized to standard of care.~   "
136297|NCT01270932|"~     Primary:~      • To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma)~     patients with various degrees of renal failure using pharmacokinetic studies~      Secondary:~        -  To evaluate the safety of lenalidomide and dexamethasone as induction therapy in~          newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified~          dosing guidelines~        -  To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using~          the modified dosing guidelines~        -  To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and~          dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure~   "
136298|NCT01270919|"~     To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed;~     and clinical qualitative assessments will improve from preoperative to postoperative time~     points with the BioDuct® Meniscal Repair Device.~   "
136299|NCT01270906|"~     Phase I dose finding study in solid tumors.~   "
136300|NCT01270893|"~     The goal of this clinical research study is to learn if Tasigna® (nilotinib) can cause tumor~     cells to shrink and/or die in patients with GIST who are scheduled for surgery or may be~     eligible for surgery. The safety of this drug will be studied. Researchers also want to use~     imaging scans to study the changes in tumor size that may be caused by using nilotinib.~   "
136301|NCT01270880|"~     Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins~     needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090~     works in treating patients with metastatic hormone-resistant prostate cancer previously~     treated with docetaxel-based chemotherapy~   "
136302|NCT01270867|"~     To determine if the Trevo Retriever is as good or better than the Merci Retriever in~     restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a~     large vessel.~   "
136303|NCT01270854|"~     The purpose of this study is to determine whether an intravenous salt solution called~     Plasmalyte causes less abnormality of the body's acid levels than a solution called~     Normal Saline.~   "
136304|NCT01270841|"~     The Purpose of the study is to determine the effects of Androxal on morning testosterone and~     reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less~     than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The~     effects of Testim versus placebo on reproductive status will also be examined. Study~     subjects must not be currently using a topical testosterone.~   "
136305|NCT01270828|"~     The purpose of the study is to explore the safety and efficacy of a new once a day~     pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)~   "
136306|NCT01270815|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or~     800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2)~     evaluate the safety and tolerability of a single dose of a pregabalin controlled release~     tablet following various sized lunches as compared to a single dose of the pregabalin~     immediate release capsule.~   "
136307|NCT01270802|"~     Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone~     problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a~     newer HIV medication, will improve vascular function and tests of bone health.~   "
136308|NCT01270789|"~     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). We propose a double-blind, randomized controlled study comparing the effect of~     liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo,~     on the preservation of beta-cell function over one year in patients with T2DM. This study~     may demonstrate an important beta-cell protective capacity of liraglutide.~   "
136309|NCT01270776|"~     The purpose of this study is to compare the efficacy of two different antiseptic solutions~     (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized~     controlled manner in cleansing the skin of infants with birth weight less than 1500 grams~     prior to a skin breaking procedure (venepuncture).~      The investigators hypothesize that the use of limited amount of 2% aqueous chlorhexidine~     solution will be as effective as the same amount of 2% chlorhexidine in 70% alcohol for skin~     antisepsis and that limited exposure to 2% aqueous CHG may be associated with less adverse~     skin reactions.~      Literature from adults has shown that both 2% chlorhexidine in 70% alcohol as well as 2%~     aqueous chlorhexidine can provide effective skin antisepsis though alcohol containing~     solution had more long lasting effect. It is also well known from many case reports that~     alcohol containing products when used to clean abdominal skin for neonatal procedures can~     cause severe skin damage in preterm infants. This has lead many neonatal units to adopt~     aqueous chlorhexidine as the antiseptic agent of choice without robust evidence to support~     its use or standardization of method of application.Both these solutions are widely used in~     neonatal intensive care units across the globe including Canada.~      By conducting this trial, the investigators want to evaluate the efficacy and safety of 2%~     aqueous chlorhexidine as an antiseptic agent when used in a controlled manner [limited~     amount for short duration].~   "
136310|NCT01270763|"~     The interplay of genetic and behavioral factors is critical to understanding obesity.~     Behavioral weight loss intervention has emerged as a key strategy in combating obesity.~     However, individuals differ in their degree of success in these programs and genetic factors~     are known to play a role. In this application, the investigators propose to identify~     specific genes that predict individual differences in weight loss and high density~     lipoprotein cholesterol in response to behavioral intervention to help identify individuals~     that struggle with weight loss and cholesterol despite behavioral efforts.~   "
136311|NCT01270750|"~     Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary~     arterial hypertension, but has also been documented in secondary pulmonary hypertension due~     to congestive heart failure, including cardiac valve disease. The investigators aim to~     examine the clinical and physiologic effects of bosentan therapy in patients with secondary~     pulmonary hypertension due to severe, inoperable cardiac valve disease, using a~     single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients~     with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be~     exercise capacity at six months determined by six-minute walking distance and~     cardiopulmonary exercise testing. Secondary end-points will be symptomatic relief,~     echocardiographic left ventricular function and pulmonary pressure, serum pro-brain~     natriuretic peptide, and adverse events at six months.~   "
136312|NCT01270737|"~     The investigators hypothesize that whole soy or purified daidzein alone could reduce blood~     pressure and CVD risks in equol-producing menopausal Chinese women.~   "
136313|NCT01270724|"~     This study will look to see how well patients with relapsed or recurrent intracranial germ~     cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine,~     Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous~     stem cell rescue.~   "
136573|NCT01267331|"~     This prospective, randomized, placebo-controlled study was designed to assess the safety,~     feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear~     cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass~     surgery.~   "
136314|NCT01270711|"~     The overall goal of this study will be to assess and monitor the adherence to and~     effectiveness of the new prescribing guidelines for cabergoline.~      Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson,~     hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline~     treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed~     doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography~     prior and during treatment. 5. The incidence and prevalence of valvular fibrosis~   "
136315|NCT01270698|"~     This is a Phase I trial to study the safety of IMMU-130. IMMU-130 is composed of a drug~     attached to an antibody. The drug is the active ingredient in irinotecan which is a common~     chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the~     immune system. They bind to substances that don't belong in the body to prevent harm to the~     body. The antibody in this study was designed to bind to a marker located on colorectal~     cancer tumors. The antibody was originally made from mouse proteins, but was changed in the~     laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts~     for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is~     safe.~   "
136316|NCT01270685|"~     The purpose of this study is to evaluate specific approaches used to prevent/reduce~     influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic,~     including assessing infection control strategies used by SCI staff and guidance provided by~     local infection control units. Due to the rapid spread of and uncertainties about the H1N1~     virus, we will evaluate patient's beliefs, behaviors, and information seeking strategies~     (e.g., social media). These findings will lend to the understanding of ways to handle~     emergent issues, such as the H1N1 pandemic, in special populations.~   "
136317|NCT01270672|"~     The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a~     alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of~     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The investigators hypothesize that~     carvedilol will attenuate the cardiovascular and subjective response to MDMA.~   "
136318|NCT01270659|"~     The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia~     in comparison to standard analgesia, to determine if the FBT allows for faster achievement~     of significant analgesia~   "
136319|NCT01270646|"~     Impact of intraventricular electrical activation in resynchronization therapy. We seek to~     evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of~     the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to~     decrease the heterogeneity of LV activation in heart failure patients. A second goal is to~     evaluate the electrical determinant of clinical response to CRT using invasive and~     non-invasive mapping technology.~   "
136320|NCT01270633|"~     The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix~     and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with~     controlled diabetes mellitus and without significantly compromised arterial circulation.~   "
136321|NCT01270620|"~     You are invited to participate in a research study assessing your mental status in the first~     days after your surgery and how you will be doing in the 2 years following the surgery. The~     investigators hope to learn more about the incidence of postoperative confusion and a~     possible relation with 2 anesthesia techniques that are routinely used. The first one is an~     anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is~     an anesthesia technique that uses the anesthetic propofol administered by infusion in a~     vein. The investigators are also looking to see if there is a relationship between~     anesthesia technique and cardiovascular outcomes. You were selected as a possible~     participant in this study because at your age this phenomenon appears to have a greater~     incidence.~   "
136322|NCT01270607|"~     The purpose of this study is to test the hypothesis that acupuncture will reduce~     Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.~   "
136323|NCT01270594|"~     Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler~     adherence in veterans with COPD who have demonstrated poor inhaler adherence through~     pharmacy refill records?~      Veterans who receive who receive daily maintenance inhalers from the William S Middleton~     Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80%~     over the previous six months will be invited to participate in the study. This study will~     randomize 100 participants to a usual care arm or a pharmacist counseling intervention.~     Final data collection will be six months after randomization to determine if both~     self-reported and refill record adherence has changed.~   "
136324|NCT01270581|"~     The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior~     respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN)~     when compared to the standard of care modality (NCPAP).~   "
136325|NCT01270568|"~     This study is investigating whether a series of psychological exercises, called positive~     psychology, provides benefit to patients who have been hospitalized for heart disease (an~     'acute coronary syndrome' or heart failure).~      In this study, subjects are randomly assigned to complete 8 positive psychology exercises~     over 8 weeks, or to complete different exercises in control groups.~      We hypothesize that patients who are assigned to the positive psychology tasks will be able~     to complete the exercises at a high rate, will feel that the exercises were easy to perform,~     and will have greater improvements of optimism, anxiety, mood, and health-related quality of~     life than subjects in the control conditions.~   "
136326|NCT01270555|"~     The investigators propose to conduct an open study to evaluate the efficacy and tolerability~     of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or~     current substance use disorders. We hypothesize that Bupropion SR will be effective in~     treating ADHD in this population.~   "
136327|NCT01270542|"~     The purpose of this study is to determine the effect of anti-VEGF drug (Avastin)~     adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in~     patients with Proliferative Diabetic Retinopathy (PDR).~   "
136369|NCT01269996|"~     To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin~     (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual~     treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal~     insulin in Type 2 Diabetes Mellitus patients.~   "
136328|NCT01270529|"~     Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will~     report participation in physical activity that falls short of recommended levels of physical~     activity; Children on dialysis will be less active.~      Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will~     be related to their disease or its treatment; those who are less active will endorse more~     barriers.~      Hypothesis #3: Patients will increase their participation in physical activity in response~     to a pedometer-based 12 week intervention.~      Baseline level of physical activity and magnitude of increase in physical activity will be~     more closely associated with change in physical functioning and performance than stage of~     kidney disease or type of renal replacement therapy.~      Exercise capacity of the child will be measured by the six minute walk test whereby the~     subject will asked to walk as far as possible in 6 minutes in a straight corridor.~      Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy.~      Physical functioning or Health Related Quality of Life will be assessed self reported/~     parent proxy reliable and validated questionnaire specifically designed for child with~     chronic kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects~     (teens) or parents will also be asked to fill out a questionnaire on barriers to physical~     activity on their first visit.~      Physical activity will be measured in the form of daily steps. The child will wear the~     pedometer for the first week to assess his/her baseline level of activity. Then the child~     will continue to wear the pedometer for another 12 weeks during which time he or she will be~     asked to gradually increase steps walked per day above baseline physical activity. The~     patient will be called once a week in order to monitor progress, set new weekly step goals~     (usually 500-1000 steps/day greater than the previous week), and motivate the participant.~      After 12 weeks of the pedometer-based intervention to increase physical activity, physical~     performance, body composition and physical functioning (as described above) will be measured~     once again to assess the effect of increased physical activity on a second visit.~   "
136329|NCT01270516|"~     The investigators will determine if administration of HMB (hydroxymethylbutyrate) or EPA~     (eicosapentaenoic acid) will increase diaphragm and limb muscle strength for patients on~     breathing machines in an intensive care unit. The investigators will first measure the~     strength of the diaphragm and a limb muscle (the quadriceps)using magnetic stimulators to~     activate these muscles. Muscle size will be measured by using an ultrasound to measure~     diaphragm thickness and quadriceps thickness. The investigators will also perform a vastus~     lateralis muscle biopsy. Patients will then be randomized to receive either placebo (saline~     30 ml every 12 hours via the GI tract, EPA (1000 mg given every 12 hours via the GI tract),~     HMB (1500 mg given every 12 hours via the GI tract), or the combination of EPA (1000 mg~     given every 12 hours via the GI tract) and HMB (1500 mg given every 12 hours via the GI~     tract). Drugs will be given for 10 days; at the end of this time (on day 11), strength~     measurements, ultrasound muscle size measurements, and the vastus lateralis biopsy will be~     repeated. On day 21 an additional followup set of diaphragm and quadriceps strength and size~     measurements will be made (the biopsy will not be repeated for this last set of~     measurements). Patients will be followed clinically and patient outcomes (mortality,~     duration of mechanical ventilation after study entry) will be recorded.~   "
136330|NCT01270503|"~     This aim of the study is to assess post-marketing safety of a single dose of Menactra®~     vaccine with the intent to support conversion from monitored release to initial registration~     of Menactra® vaccine in the Philippines.~      Primary Objective:~      To describe the serious adverse events occurring within 30 days among participants who have~     received one dose of Menactra® vaccine.~   "
136331|NCT01270490|"~     The purpose of this study is to assess the feasibility and preliminary efficacy of~     interferon-gamma in combination with anidulafungin for the treatment of candidemia~   "
136332|NCT01270477|"~     The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as~     adjuvant treatment for frost damage.~      The investigators hope to include at least 20 patients in a randomized manner. Half of the~     patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to~     have hyperbaric oxygen treatment.~      Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as~     adjuvant treatment for frost damage. The functional level of the frost damaged patient is~     better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost~     damage.~   "
136333|NCT01270464|"~     The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3~     or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than~     placebo in improving lung function in patients with eosinophilic asthma as assessed by the~     overall change from baseline in forced expiratory volume in 1 second (FEV1).~   "
136334|NCT01270451|"~     Primary Outcomes:~        1. To study cross-sectional associations between diet, physical activity, T2DM and weight~          in subjects 2 yrs after surgery.~        2. To study if subjects receiving extra guidance in diet and physical activity experience~          less weight gain compared to a control group.~           Secondary Outcomes:~        3. To study the association between vit.D levels and T2DM.~        4. To study the association between weight change and QOL.~        5. To validate the new guidance strategy by recording food intake, energy expenditure and~          physical activity level.~        6. To study if subjects receiving extra guidance in diet and physical activity experience~          other health effects compared to a control group.~        7. To search for biomarkers that can identify people at risk of increasing weight post~          surgery~   "
136335|NCT01270438|"~     This phase II clinical trial is studying how well giving combination chemotherapy and~     bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal~     cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to~     them. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. It is not yet known whether combination chemotherapy and bevacizumab is~     more effective with RO4929097 in treating patients with colorectal cancer.~   "
136336|NCT01270425|"~     Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the~     skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is~     prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune~     disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general~     population, although some reports suggest they might be more frequent in patients with SSc.~     Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid~     cancer.~      The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc~     with and without Hashimoto's disease~   "
136337|NCT01270412|"~     Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in~     osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the~     effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.~   "
136574|NCT01267318|"~     Development of a new diagnostic detection tool for gastrointestinal bleeding.~   "
136338|NCT01270399|"~     Lung cancer remains the most common cause of cancer-related death in the world. The major~     advances in treatment of lung cancer have brought only minor improvements in survival~     therefore novel systemic treatment methods are urgently needed.~      Protein levels are regulated by the protein homeostasis network that generates and protects~     the protein fold (ER and Golgi included).~      The heat shock protein 90 (Hsp90) is an essential molecular chaperon involved in the~     posttranslational folding and stability of proteins. Hsp90 inhibition leads to accumulation~     of unfolded proteins and ER stress. The therapeutic efficacy of such inhibition may be~     augmented by co-administering it with other drugs that disrupt ER-Golgi homeostasis like~     histone deacetylase (HDAC) or proteasome inhibitors. ER-Golgi homeostasis disruption affects~     a wide network of proteins and pathways as such affords a systemic target. Thus, the~     investigators aimed to examine the effect of combined treatment of Hsp90 antagonist with~     proteasome or HDAC inhibitors on human lung cancer cell lines and primary cells.~   "
136339|NCT01270386|"~     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor~     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests.~     Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable~     daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve~     progression free survival compared with placebo in patients with advanced non-squamous and~     non-small cell lung cancer who failed two lines of chemotherapy.~   "
136340|NCT01270373|"~     The purpose of this study is to evaluate the usual and the reverse sequence of an~     anthracycline followed by a taxane in locally advanced breast cancer.~   "
136341|NCT01270360|"~     Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult~     blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples,~     followed by colonoscopy if the result is positive. The information quality of the Hemoccult~     test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection~     sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to~     50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete~     colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood~     in stools are currently being evaluated; based on the threshold it can be more sensitive~     than FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of~     blood in stools, it may become highly specific and miss less advanced polyps. Faecal~     molecular tests based on the detection of human DNA anomalies (point gene mutations,~     methylation disorders of CG islets) appear to be more sensitive than the detection of occult~     blood in stools with no loss of specificity, but they are very expensive, thereby limiting~     their generalisation to the scale of population screening. A formal methylated DNA test has~     been validated in stools as well as in blood in a cohort of symptomatic individuals having~     undergone colonoscopy. The aim of the present study is to validate this test by taking~     advantage of the biotechnical expertise from renowned academic research teams and mass~     screening organisation.~   "
136342|NCT01270347|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa,~     which has been particularly problematic to eradicate and been implicated as the major cause~     of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the~     lung increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Bacterial resistance to~     current aerosol antibiotic treatments indicate a need for improved therapies to treat CF~     patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and~     other bacteria. High concentrations of MP-376 delivered directly to the lung are projected~     to have antimicrobial effects on even the most resistant organisms.~   "
136343|NCT01270334|"~     vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally~     for missed abortions in the first trimester~   "
136344|NCT01270321|"~     The purpose of this study is to determine the effectiveness of two anticancer drugs,~     everolimus and pasireotide, in patients with thyroid cancer when the cancer is no longer~     responding to treatment with radioiodine or where it is deemed unsafe for the patient to~     receive additional radioiodine treatment. The investigators also want to establish the best~     manner of taking the two medications when used together to treat thyroid cancer. In~     particular, the investigators want to know if it is better to give both at the same time or~     add a second medication after the first one has stopped working.~      This study will also look at specific substances called biomarkers in your blood, and in the~     tumor tissue which are involved in the growth of tumor cells, and determine if the levels of~     these biomarkers are related to your response to treatment or development of side effects.~      Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food~     and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing~     cancer cells from multiplying and it also makes them more likely to die from the treatment.~      Pasireotide also known by the name, SOM230 is a new medication that is not yet approved by~     the FDA for the treatment of cancer. It is a newer form of a drug called octreotide, which~     is approved for the treatment of cancer arising from endocrine organs. Pasireotide works by~     binding to a protein called somatostatin receptor, which is expressed in many tissues~     throughout the body including thyroid cancer cells. Pasireotide prevents the action of~     somatostatin by binding to these receptors.~   "
136345|NCT01270308|"~     The objective of this study was to compare the relative bioavailability of Lansoprazole DR~     Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human~     subjects.~   "
136346|NCT01270295|"~     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar~     epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the~     pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the~     RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data~     are available about the levels of soluble forms and ligands of RAGE in the setting of~     ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms~     (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with~     ALI/ARDS.~   "
136347|NCT01270282|"~     The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic~     AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear~     tinnitus.~   "
136348|NCT01270269|"~     Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal~     cost to ICU survivors who frequently experience significant cognitive impairment and an~     array of physical and functional disabilities that limit their recovery and quality of life.~     While the problems experienced by these patients are likely amenable to rehabilitation, few~     ICU survivors receive focused rehabilitation. Recently, early physical rehabilitation in ICU~     patients has shown to improve the chances a patient will regain their pre-hospital~     functional status. Early cognitive rehabilitation for these patients has not yet been~     explored. This pilot study will determine the feasibility of early cognitive rehabilitation~     in ICU patients. The investigators will perform cognitive and physical rehabilitation,~     beginning in the earliest phases of critical illness, to determine the effect of these~     therapies on cognitive and functional outcomes in ICU survivors. The investigators~     hypothesize that combined cognitive and physical rehabilitation, started in the ICU, will~     improve recovery of cognitive and physical function as well as improve quality of life of~     ICU survivors.~   "
136349|NCT01270256|"~     The purpose of this study is to see if a nasal steroid drug delivered to the nose with the~     NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year~     round allergy symptoms).~   "
136350|NCT01270243|"~     We, the investigators, propose to look at the bacteria on and in tonsils using gene~     microarrays. We expect to find previously reported bacteria but also the possibility of~     previously undetected organisms. We think that the bacterial pathogens present on the~     tonsillar surface are different from the tonsil core. And we also think that the bacteria of~     the tonsil surface will differ between patients undergoing adenotonsillectomy and normal~     controls with no adenotonsillar problems.~   "
136351|NCT01270230|"~     African American men who have sex with men and women (AAMSMW) are at particular risk for~     contracting and transmitting HIV, and represent a priority population for developing~     effective interventions. Despite the urgent need for effective prevention approaches for~     AAMSMW, to our knowledge no evidence-based HIV interventions have been developed and tested~     for this population. This study is a randomized controlled trial of the Bruthas Project(BP),~     an individual-level HIV prevention intervention, which builds on standardized HIV counseling~     and testing. Delivered in a series of four sessions by trained African American male~     counselors, the BP focuses on reviewing HIV transmission routes for male and female~     partners, strengthening sexual communication skills with both male and female partners, and~     improving condom use skills and other safer sex negotiation strategies. A randomized~     controlled trial of BP is necessary to determine the efficacy of the intervention and can~     lead to improved public health efforts at reducing HIV risk behavior among AAMSMW and in the~     African American community more generally. To evaluate the effect of the BP, the~     investigators will recruit and enroll a cohort of 400 AAMSMW who will be randomly assigned~     to either the intervention condition, in which they will be offered BP, or to the comparison~     condition, in which they will receive standardized HIV testing and counseling with referral~     to case management. The investigators will follow the cohort over 9 months and will assess~     participants at three time points: baseline, 3 months follow-up, and 6 months follow-up.~   "
136352|NCT01270217|"~     The purpose of this study is to determine whether brief motivational interviews reduce~     problematic drinking behavior among individuals arrested for the first time for driving~     under the influence of alcohol (DUI).~   "
136353|NCT01270204|"~     The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to~     evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of~     viscosity on swallowing efficiency.~   "
136354|NCT01270191|"~     Whether GLP-1 and GLP-1 receptor agonists will produce a sustained improvement in beta-cell~     function following short-term therapy is currently not known. This randomized, controlled~     trial is carried to assess the efficacy of short-term insulin therapy (NPH injection twice~     daily) compared with GLP-1 analogue (Exenatide injection twice daily) on glycemic control,~     remission rate, ß-cell function, and long-term glycemic control in newly diagnosed type 2~     diabetic patients with moderate hyperglycemia.~   "
136355|NCT01270178|"~     Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in~     turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients~     who underwent curative therapy died from progressive liver decompensation rather than~     recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus~     (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical~     resection.~      This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B~     patients after receiving RFA therapy for HCC.~   "
136356|NCT01270165|"~     No study has reported on the comparative effect of continuing lamivudine plus adefovir~     versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory~     chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The~     goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus~     switching to telbivudine plus adefovir directly in patients with lamivudine-refractory~     chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at~     least 12 months.~   "
136357|NCT01270152|"~     The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally~     implanted central venous catheter~   "
136358|NCT01270139|"~     The investigators hypothesize that the nanoburning is very challenging technique to demolish~     and reverse the plaque especially in combination with stem cell technologies promising~     functional restoration of the vessel wall.~      The completed (in July 2012) interventional three arms (n=180) first-in-man trial (the~     NANOM-FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery~     techniques for nanoparticles (NP), and plasmonic photothermal therapy (PPTT) of~     atherosclerotic lesions. Patients were assigned in a 1:1:1 ratio to receive either (1)~     nano-intervention with delivery of silica-gold NP in mini-surgery implanted bioengineered~     on-artery patch (n=60), or (2) nano-intervention with delivery of silica-gold iron-bearing~     NP with targeted micro-bubbles or stem cells in hands of magnetic navigation system (n=60)~     versus (3) stent implantation (n=60). The primary outcome was TAV at 12 months.~      The observational prospective cohort analysis (an amendment to the protocol of August 29th~     2012 with a decision to extend a 1-year study for another 4 years with the assessment of the~     5-year clinical outcomes both retro- and prospectively) of the long-term clinical outcomes~     at the intention-to-treat population of 180 patients with CAD and angiographic SYNTAX score~     ≤22 enrolled initially to NANOM-FIM trial will be performed at 5 years after the~     intervention. The primary outcome will be a MACE-free survival. The secondary outcomes will~     be MACE, cardiac death, TLR (target lesion revascularization) and TVR (target vessel~     revascularization). Imaging endpoints will be assessed pre-, post- procedure and at 12-month~     follow-up. Clinical endpoints will be analyzed at the baseline and at 12 and 60-month~     follow-up (the release of results is expected after October 2016). Parameters of~     nanotoxicity will be assessed.~      The subset post-hoc analysis will be conducted at 1- and 5-year follow-up (by the Amendment~     of August 29th 2012). At the first subset patients underwent stenting with XIENCE V stent~     proximal to the site of nano-intervention (n=13). Subjects in the second subset were~     undergone drug-coated balloon pre-dilation with further nano-technique (n=20). Lesions in~     patients of the third subset were not prepared for the nano-approach (n=147) (neither~     stenting nor balloon angioplasty). The analysis will be performed and results will be~     released in 2017 with the same clinical outcomes.~      This project and related manuscripts were not prepared or funded in any part by a commercial~     organization. Nanoparticles and biomedical equipment were supplied free for the study by the~     non-profit Agiko and De Haar Foundation (Rotterdam, the Netherlands). All rights of the~     authors are reserved. The access of the international academic or governmental organizations~     to the essential and primary data of the trial is restricted by the Russian governmental~     authorities due to interest of the Russian Federal Security Service (FSB).~   "
136359|NCT01270126|"~     Non-invasive brain stimulation can increase cortical excitability in the visual system, but~     it is not known if this is of clinical value. The investigators now assessed if repetitive,~     transcranial alternating current stimulation (rtACS) can improve visual field size in~     patients with optic nerve damage. The investigators hypothesized that rtACS would improve~     visual functions within the defective visual field sectors of the visual field (primary~     outcome measure).~   "
136370|NCT01269983|"~     The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back~     pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8~     physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4~     Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization~     and stretching exercises); whereas the second (control) will receive only the standard~     approach.~   "
136575|NCT01267305|"~     The purpose of this study is to determine whether the use of different dose of LMWH compared~     with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.~   "
136360|NCT01270113|"~     China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to~     concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China~     has recently implemented methadone maintenance treatment (MMT) programs nationwide. One~     problem noted with this rapid expansion is that the dropout rates from MMT have been high.~     The proposed study will adapt a motivational incentives (MI) intervention developed in the~     United States for use in Chinese MMT settings and will pilot test its effectiveness in~     improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a~     motivational incentives intervention in MMT in China, and 2. to experimentally pilot test~     the motivational incentives intervention. A secondary aim is to explore factors that may~     influence the outcomes of MMT that incorporates a motivational incentives intervention. It~     is hypothesized that the MI intervention can be adapted to Chinese settings and that it will~     optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The~     collaborative team includes researchers in American and Chinese institutes (UCLA/Johns~     Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse),~     officials from national and local Chinese Centers for Disease Control and Prevention, and~     providers in local MMT clinics in Shanghai and Yunnan.~   "
136361|NCT01270100|"~     The purpose of the study is to develop and pilot-test a Recovery Management Intervention~     (RMI) program for heroin addicts released from compulsory rehabilitation in China.~      The project has the following specific aims:~      Primary aims:~      Aim 1. To engage key stakeholders in the local communities involved in supporting the~     transition of heroin addicts released from compulsory rehabilitation to the community; Aim~     2. To identify potential barriers for participating in MMT in China; Aim 3. To develop and~     deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To~     adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts~     released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain~     preliminary outcome data associated with RMI, relative to enhanced standard care.~      Secondary aim:~      Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.~      It is hypothesized that the intervention will reduce drug use relapse and the negative~     consequences associated with relapse, including HIV risk behaviors~   "
136362|NCT01270087|"~     The purpose of this study is to determine whether anti-inflammatory treatment with~     adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active~     rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before~     treatment and after 3 months, and related to other biomarkers and clinical outcomes.~   "
136363|NCT01270074|"~     The general aim of this project is to conduct a randomized, double-blind, placebo-controlled~     clinical trial of azithromycin to determine whether treatment from infancy is safe and will~     prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from~     CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The~     primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years~     of age. Safety and mechanistic evaluations will also be undertaken.~   "
136364|NCT01270061|"~     Project Wellness is a new intervention that combines the use of culturally-sensitive,~     video-based education, a general health screening approach, and a community pharmacy setting~     into one program to improve black African immigrant participation in voluntary HIV testing.~     The study is divided into three phases: qualitative research; video production; and a~     feasibility trial. In Phase 1, the investigators will conduct in-depth interviews and focus~     group discussions with black African participants to obtain insights on overlapping and~     resonating themes that will help increase participation in HIV testing among black Africans~     in the Bronx. In Phase 2, data obtained through qualitative work will guide the development~     of four health education videos. A culturally-tailored educational video on diabetes,~     hypertension, and HIV will be developed and produced for each gender and in both English and~     French. In phase 3, the investigators will test the feasibility of a pharmacy-based,~     culturally-tailored, general health screen that includes rapid HIV testing. The trial will~     help determine the feasibility of using a computer-based model; recruitment of black~     Africans in the pharmacies; acceptance of testing; and linking individuals diagnosed with~     health problems into medical care. A secondary analysis will also determine predictors of~     refusing to be tested.~   "
136365|NCT01270048|"~     The purpose of this research is to examine the effect of Bunsimgi-eum on the chest~     discomfort of Hwa-byung's major symptom and develope and establish pattern identification~     system in Hwa-byung.~   "
136366|NCT01270035|"~     In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg~     every other week when used in combination with methotrexate (MTX) for patients with~     rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients,~     especially for those with high disease activity. Therefore, we tried to increase the ADA~     dose to 80 mg every other week with concomitant MTX, only if the disease activity did not~     decrease below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate~     of patients who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined~     treatment strategy.~   "
136367|NCT01270022|"~     The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular~     risk, with a local adaptation model of the existing guidelines in clinical practise at~     present, of each of the different cardiovascular risk factors, and the implementation~     strategy.~   "
136368|NCT01270009|"~     MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug~     combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until~     now, lack of specific markers of the disease has not allowed efficient specific molecular~     targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a~     novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to~     confirm that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential~     therapeutic target of MM. Targeting Bcl-2 family member's is a promising strategy for the~     treatment of hematopoietic malignancies. In this context, specific targeting of Bcl-B could~     improve the treatment of patients suffering MM. Of note, this could be achieved by~     converting the antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of~     small mimetic peptides derived from Nur77 one of its interactors.~   "
136606|NCT01266902|"~     The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients~     who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.~   "
136371|NCT01269970|"~     Early metabolic response evaluation may predict clinical and histopathological response~     after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown.~     Our aim was to assess the value of early metabolic response after one cycle of chemotherapy~     using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal~     cancer treated by neoadjuvant CRT and esophagectomy.~   "
136372|NCT01269957|"~     Objective: determine whether there is a correlation between halitosis and mouth breathing in~     children. Study design: Fifty-five children between three and 14 years of age were divided~     into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive~     analysis was carried out regarding the degree of halitosis in each group. The chi-square~     test was used for the comparison between groups, with 5% level of significance.~   "
136373|NCT01269944|"~     Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention~     called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain~     improves following this procedure, it is unknown how cartilage quality is affected by the~     procedure. In this study, a recently developed MRI technique is used to evaluate changes in~     cartilage quality before and after the surgery. Changes in MRI signals are correlated to~     subjective improvements (score lists). 10 patients participate in this study. Approval has~     been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All~     participants are required to give informed consent before participation.~   "
136374|NCT01269931|"~     Bronchoscopy is a procedure whereby a small flexible camera is used to inspect and biopsy~     abnormalities in the lungs. Linear endobronchial ultrasound with transbronchial needle~     aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows~     visualization and safe, accurate biopsies of structures in and around the lungs during~     bronchoscopy. EBUS-TBNA can be challenging to learn.~      Historically, bronchoscopy has been taught using an apprenticeship model, whereby trainees~     practice on patients. With the introduction of computer bronchoscopy simulators, trainees~     can now obtain basic bronchoscopy skills by practicing on the simulator, rather than~     practicing on patients.~      This study aims to compare trainee EBUS-TBNA performance during actual procedures on~     patients, following training with a computer EBUS-TBNA simulator versus conventional~     clinical EBUS-TBNA training (trainees taught by practicing on patients). Our hypothesis is~     that the skills learned using a computer EBUS-TBNA simulator are transferable to clinical~     EBUS-TBNA performance, meaning that using a computer EBUS-TBNA simulator for training is~     just as good as learning these skills by practicing on patients.~      The use of EBUS-TBNA simulators for training could have the advantage of minimizing the~     burden of procedural learning on patients.~   "
136375|NCT01269918|"~     This will be a randomized blinded clinical trial. Patients will be randomized to receive~     either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia~     team will know the result of randomization at induction. Data will be gathered by research~     personnel who will be blinded to the anesthetic method used. Patients will be blinded to the~     anesthetic they receive till they are discharged from the PACU when they will have the~     option to be unblinded. The Data Safety and -Toxicity Committee will review all serious~     adverse events and toxicity reports as well as annual reviews.~   "
136376|NCT01269905|"~     The optimal valve substitute for patients between 60-70 years is controversial. We compared~     anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve~     replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the~     risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not~     requiring permanent anticoagulation.~   "
136377|NCT01269892|"~     The purpose of this study is to determine which nutritional regime is better for acute~     diarrhea in outcomes.~   "
136378|NCT01269879|"~     A number of different therapeutic approaches to treat lateral epicondylitis have been tested~     partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A~     injections, braces, surgery and topical NO patches.~      One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy)~     have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al.,~     J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.)~      Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The~     investigators hypothesize that a dedicated proprioceptive intervention might be able to~     reduce pain and improve function.~      As such a RCT is planned with two intervention arms with proprioceptive training using the~     Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk)~     over twelve weeks.~   "
136379|NCT01269866|"~     The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain~     severity in patient with Systemic Lupus Erythematosus.~   "
136380|NCT01269853|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of~     either surgical resection, external beam radiation or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if~     currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The~     investigators have shown in a previous phase I trial that a single Super-selective~     Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective~     in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an~     extension of that trial in that the investigators seek to test the hypothesis that repeated~     dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent~     malignant glioma. By achieving the aims of this study the investigators will also determine~     if IV therapy with Bevacizumab should be combined with repeated selected intraarterial~     Bevacizumab to improve progression free and overall survival. The investigators expect that~     this project will provide important information regarding the utility of repeated SIACI~     Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to~     the patients in the near future.~   "
136607|NCT01266889|"~     The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured~     by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.~   "
136381|NCT01269840|"~     In severe injuries of the radial head with multiple, displaced fracture fragments and~     concomitant ligament damage, excision of the fragments and replacement of the radial head~     with a metallic implant are indicated. Current radial head implants are composed of metal or~     a combination of metal and high molecular weight polyethylene. The prostheses are assembled~     intra-operatively as a solid unit (monopolar) or as an articulating implant with motion~     between the stem and head (bi-polar). The stem of the implant is inserted into the proximal~     radius for support and can be classified as either loose-fitting or fixed. According to the~     investigators, there are no studies that directly compare the clinical and radiographic~     outcomes between different radial head implant designs. The purpose of this retrospective~     study is to compare the clinical and radiographic results in patients treated for an~     irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a~     monopolar, in-growth radial head implant. The study findings may provide useful clinical~     information regarding the similarities and differences in these two implant designs.~   "
136382|NCT01269827|"~     The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of~     TNF-α, IL-6, and CRP in patients on hemodialysis.~   "
136383|NCT01269814|"~     The patients who admit to emergency department with upper gastrointestinal system bleeding~     will undergo a clinical evaluation with Rockall Risk Scoring System. The patients with~     Rockall score of 1 or less will be discharged with medical treatment, and will have an~     elective upper gastrointestinal endoscopy in the end of the 30th day. The impact of Rockall~     Risk Scoring System on assessing the necessity of emergency endoscopy, length of hospital~     stay, morbidity, and mortality in low-risk patients will be evaluated.~   "
136384|NCT01269801|"~     The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC,~     and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic~     treatment of age-associated wrinkles and folds of the face.~   "
136385|NCT01269788|"~     Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the~     adult population in North America. Up to 70% of GERD patients have non-erosive reflux~     disease (NERD), a term used to describe symptoms suggestive of GERD in patients with no~     endoscopic evidence of erosive esophagitis. NERD represents a heterogeneous group of~     patients whom are sub classified according to 24 hours-PH monitoring results and also~     symptom-acid association analysis(Symptom Index,SI).~      Treatment of NERD can be a challenge for clinicians. According to the many studies , the~     pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as~     the most frequently used drug, in NERD patients is lower than for erosive esophagitis~     patients. It is also shown that acid exposure is much lower in NERD patients than those with~     erosive esophagitis and NERD patients are less likely to exhibit a strong association~     between heartburn symptoms and acid reflux events than patients with erosive oesophagitis.~      Furthermore, beside the high economic burden, there are concerns about the adverse effects~     of long time administration of PPIs.~      Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs.~     One of the most acceptable theories is that patients with anxiety or depression and~     psychological problems are at an increased risk of developing reflux symptoms. On the other~     hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI),~     and other antidepressants have been shown to improve symptoms in patients with functional~     gastrointestinal disorders like non cardiac chest pain.~      According to the above-mentioned tips, the investigators hypothesize that antidepressants~     like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD~     patients.~      The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo~     for treatment of NERD patients and its subgroups who all experience reflux symptoms and have~     normal endoscopic findings.~   "
136386|NCT01269775|"~     The investigators carried out a randomized controlled trial comparing three methods of~     teaching. These three instructional methods consist of face to face lecture, interactive~     internet based teaching and computer based teaching (lecture synchronized with~     presentation).~      The hypotheses tested were: a) whether there is a difference between these three methods in~     knowledge achievement and b) whether there is a difference between Students satisfaction in~     three groups.~   "
136387|NCT01269762|"~     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a~     significant cholesterol lowering effect which might be caused by addictive and/or~     synergistic effects of lovastatin (monacolin K) with other monacolins and substances in~     capsules. The usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is~     one capsule twice/day.~      However, the pharmacokinetic profile of red yeast rice capsule (LipoCol Forte)is still~     unknown.~      The objective of the study is to evaluate the pharmacokinetic profile of red yeast rice~     capsule (LipoCol Forte) after administering single and multiple dose to healthy subjects.~   "
136388|NCT01269749|"~     The investigators hypothesize that 131I is an effective therapy for children with Graves'~     Disease (GD) and will not be associated with long-term cancer risks when used in older~     children, but may be associated with excessive levels of whole body radiation in young~     children. To address issues of 131I safety and cancer risk in the pediatric population, the~     investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure~     following 131I therapy in children treated for GD (2) the investigators will assess~     chromosome translocation as related to age and dose of 131I.~      It is anticipated that these studies will provide new insights into RIA use in children and~     provide important information about radiation exposure associated 131I use in children. As~     such, these studies are expected to result in new recommendations for 131I use in the~     treatment of pediatric GD.~      Funding Source - FDA OOPD~   "
136389|NCT01269736|"~     The purpose of this study is to test the effect of implementing new practice standards for~     electrocardiographic (ECG) monitoring on nurses' knowledge and skills, quality of care, and~     patient outcomes. The investigators hypothesize that increased knowledge and skills of~     nurses will lead to enhanced quality of care, which will result in improved outcomes for~     patients.~   "
136401|NCT01269580|"~     Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation~     Duration: The patients are enrolled for the time of the blood withdrawl.~      Follow up visit will be after 12 months from the enrollement.~      Objectives:~      The project will have two major objectives:~      A)To validate the prognostic value of vascular progenitor cells, identified by flow~     cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes~     complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation,~     post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb~     B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the~     perspective of new therapies for the cure of the diabetic foot.~   "
136608|NCT01266876|"~     The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in~     participants diagnosed with heterozygous familial hypercholesterolemia (heFH)~   "
136390|NCT01269723|"~     Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant~     chemical called sulforaphane (SFN) which boosts production of certain defense enzymes that~     increase the activity of antioxidants. In animals, the chemical protection from SFN helps~     prevent diseases associated with inflammation and cancer among others, and this is currently~     being studied in humans.~      Young broccoli sprouts have a particularly high level of SFN compared to other foods. The~     purpose of this research study is to learn about short term responses to live attenuated~     influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and~     nonsmoking volunteers treated with broccoli sprout homogenates (shake) or a placebo~     homogenate. This will be done by obtaining a series of nasal lavages or rinses of your~     nose with salt water, as well as 3 superficial biopsies of the inside lining of your nose~     both before and after you receive the vaccine. Using these samples, we will measure the~     amount of virus and the amount of inflammation in your nose and compare how smokers and~     nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate (high in~     SFN) or a placebo alfalfa spout shake which is low in SFN during each of 4 study visits.~      Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to~     receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm~     while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening,~     subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will~     receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects~     will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal~     biopsies will performed prior to and after study interventions.~   "
136391|NCT01269710|"~     The purpose of this study is to get a better understanding of the side effect burden and~     identify predictors of psychotic, mood and aggressive disorders in children and adolescents.~     The study's primary aim is to identify genetic risk factors for weight gain and metabolic~     abnormalities.~   "
136392|NCT01269697|"~     Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina~     (named macula) and is the leading cause of blindness in industrialized countries. There is~     growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin)~     of dietary origin, which specifically accumulate in the macula, where they form the macular~     pigment. A first step towards the demonstration of a preventive effect of macular pigment~     for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on~     their plasma and retinal concentrations.~   "
136393|NCT01269684|"~     The purpose of this study is to investigate safety and tolerability of an immediate~     conversion from Tacrolimus to everolimus in stable renal allograft recipients.~      Interest in developing CNI-free regimens using other agents such as the proliferation signal~     inhibitor everolimus.~   "
136394|NCT01269671|"~     IND application was submitted to FDA on November 17th.~   "
136395|NCT01269658|"~     The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic~     solution, 1% versus vehicle over a four-week treatment period in treating the signs and~     symptoms of subjects with blepharitis and to evaluate the clinical course of the condition~     under study.~   "
136396|NCT01269645|"~     The primary objective of this project is to examine the impact of providing cancer patients~     with audiovisual information about clinical trials on attitudes towards clinical trial~     participation. It is hypothesized that patients provided these materials will have more~     favorable attitudes toward clinical trial participation compared to patients not provided~     these materials.~      Participants will be randomized to either: (1) an intervention condition in which they will~     be asked to view a short video and read an accompanying brochure about clinical trials~     developed by the investigative team; or (2) a control condition in which they will be asked~     to read the National Cancer Institute's brochure entitled Taking Part in Cancer Treatment~     Research Studies. Self-report data will be collected at two timepoints: 1) in person~     following study enrollment, but before receipt of material related to intervention~     assignment (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following~     study enrollment (follow-up/Time 2). In addition, data will also be collected from medical~     records six weeks after study enrollment.~   "
136397|NCT01269632|"~     Background: With the improvement of the prognosis for HIV-infected infants, thanks to the~     availability of antiretroviral therapies, young adults infected with HIV since birth are~     becoming an emerging group among the HIV-infected population. Morbidity, mortality and~     immunovirological evolution in these young adults need to be studied in a large population~     and compared to patients infected with HIV later in adulthood or to the general population~     in terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV~     and/or antiretroviral therapy, is particularly interesting in this population.~      Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2~     perinatally infected young adults: 1) To study the teenager to adult transition in terms of~     clinical and immunovirological status, schooling and professional integration, sexuality and~     reproductive life, transition from paediatrics to adult departments; 2) To study prognosis,~     morbidity and mortality according to age, infection stage at the time of antiretroviral~     initiation and therapeutic history; 3) To study the incidence and expression of adverse~     events and the potential link to antiretroviral therapies; 4) To study the markers of a~     potential premature ageing, from the metabolic, cardiovascular and immunological points of~     view.~   "
136398|NCT01269619|"~     Lower back pain is one of the most common conditions affecting humans. Lower back supports~     are a common device used in order to alleviate the pain. All the available back supports are~     wrapped around the lower back and abdomen and act as static support devices. The hug is a~     new dynamic back support where the participant actively improves his/her posture and~     strengthens the muscle of the lower back. This trial compares both devices and their effect~     on reducing lower back pain.~   "
136399|NCT01269606|"~     This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at~     which rate the body eliminates the substance from the body) of insulin aspart with~     fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM)~     injection in Japanese subjects with type 1 diabetes mellitus.~   "
136400|NCT01269593|"~     The purpose of this study is to see how a new drug, named PUH71, accumulates in the~     different parts of the body & inside tumors and how long PUH71 lasts in the blood, when~     given to study participants in tiny amounts. The results of this study will help researchers~     (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the~     treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug~     for detecting tumors with scanner machines.~   "
136508|NCT01268189|"~     This is a single-center, prospective, randomized, and controlled study to evaluate the~     effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites~     compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean~     healing time for wounds treated with the OxyBand dressing will be less than the mean healing~     time for wounds treated with the Xeroform dressing.~   "
136402|NCT01269567|"~     After rectal excision, the rate of anastomotic leak and abscess is higher than after colic~     surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a~     prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness~     of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice~     had never been evaluated in patients with rectal excision and low anastomosis (patients with~     a high risk of pelvic sepsis)~   "
136403|NCT01269554|"~     Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The~     majority of deaths are among children in developing countries, but the travellers encounter~     the disease as well. The studies on the aetiology have suffered from serious methodological~     deficiencies and the results are even controversial. At the same time, the current~     diagnostic methods are inadequate. The investigators have recently developed novel multiplex~     RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a~     collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the~     causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to~     tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes~     stool samples will be collected from volunteers of different age groups and from healthy~     volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition~     to pathogens, other intestinal microbes and antimicrobial resistance will be investigated~   "
136404|NCT01269541|"~     The purpose of this study is to determine whether systemic antibiotic treatment with~     rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with~     mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers~   "
136405|NCT01269528|"~     Protocol Synopsis: There is a link between early RSV infection and chronic respiratory~     morbidity.~      Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory~     morbidity.~      Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity~     (AHR) in children born at 29-32 weeks.~      Secondary objective: to assess prospectively the effect of palivizumab on respiratory~     morbidity airway inflammation and allergy in children born at 29-32 weeks.~      Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.~      Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary~     dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known~     immunodeficiency, or receipt of other RSV investigative vaccines or therapies.~      Primary end points: Airway reactivity as assessed by methacholine challenge test with~     determination of PC20.~      Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone~     interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.~      Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born~     during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37~     premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis~     for this group in Israel).~      Statistics: A sample size of 37 patients was calculated as necessary to detect a difference~     of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline~     characteristics will be compared using 1-way analysis of variance for quantitative variables~     and Fisher's exact test for categorical variables.~   "
136406|NCT01269515|"~     Chronic immune activation is a central feature of HIV-infection, and the degree of activated~     T-cells is a better predictor of disease progression and mortality than plasma viral load.~     The study hypothesis is that the anti-inflammatory substance etoricoxib will dampen chronic~     immune activation and improve the effect of T-cell dependent vaccines in HIV-1 infected~     patients.~      The aim of the present study is to explore the efficacy of the study drug on markers of~     immune activation and vaccine responses, as well as safety of the study drug, in~     HIV-infected patients not receiving antiretroviral therapy.~   "
136407|NCT01269502|"~     A randomised controlled pilot study on the feasibility of introducing a skin temperature~     device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have~     had a foot ulcer in Norway.~   "
136408|NCT01269489|"~     The purpose of the study is to obtain reference data on health-related quality of life for~     the functional and symptom scales and single items of the European Organisation for Research~     and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a~     representative sample of Slovenian general population.~   "
136409|NCT01269476|"~     This is a randomised, double-blind, group-sequential, placebo-controlled, safety and~     pharmacokinetic study in healthy, aged volunteers.~      Objectives:~        1. to confirm the previously reported safety profile of oral SNX-001 after single and~          multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo~        2. to establish SNX-001 pharmacokinetic profile.~   "
136410|NCT01269463|"~     The time course of response following one dose of a new methylphenidate hydrochloride~     extended release capsule is studied in children 6-12 years in a simulated laboratory~     classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been~     formulated for daily dosing to provide treatment of a child with ADHD for the substantial~     day.~   "
136411|NCT01269450|"~     Working hypothesis and aims:~      To investigate whether progesterone treatment affects the incidence of preterm labor~     compared to placebo, among women with 2nd trimester bleeding.~      The participants will be allocated through randomization to a study or control group. Women~     in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an~     intra-vaginal tablet once daily while the control group will receive placebo. Both women and~     medical staff will be blinded to group allocation. Treatment will commence on the day of~     inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation.~     Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal~     outcome.~   "
136412|NCT01269437|"~     This is an open-label, randomized, parallel Group, multicenter study to evaluate the~     efficacy and safety of budesonide novolizer dry powder inhaler compared with budesonide~     turbuhaler dry powder inhaler in Chinese mild to moderate asthma patients.~   "
136438|NCT01269099|"~     The increase in stress hormone level and hyperventilation caused by the postoperative pain~     may contribute to the development of hypokalemia during postoperative period. Therefore, if~     the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during~     the postoperative period may be not affected by stress response. The researchers tried to~     investigate the effect of IV-PCA on potassium regulation during the postoperative period.~   "
136413|NCT01269424|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to~     the drug. Giving genetically modified peripheral blood stem cells during or after treatment~     may prevent side effects caused by chemotherapy.~      PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with~     genetically modified peripheral blood stem cells in treating patients with newly diagnosed~     glioblastoma multiforme.~   "
136414|NCT01269411|"~     This phase I trial is studying the side effects and best dose of RO4929097 in treating~     patients with recurrent invasive gliomas. RO4929097 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
136415|NCT01269398|"~     Utilization of trans-pedicular trans-discal implants for stabilization of a single lumbar~     motion segment, in conjunction with posterior facets fusion. The trajectories are planned~     and achieved by means of the SpineAssist® system - a computerized, image-based guidance~     system that assists surgeons in precisely guiding spinal surgical tools and implants in line~     with a CT-based pre-operative plan. GO-LIF and SpineAssist are CE marked products.~      Thy study's objective is to to collect data regarding the ability to achieve solide fusion,~     comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous~     posterior facets fusion.~   "
136416|NCT01269385|"~     RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic~     lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological~     therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may~     stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells.~     Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with~     monoclonal antibodies, such as alemtuzumab and rituximab, more effective.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan~     when given together with alemtuzumab and rituximab and to see how well it works in treating~     patients with earlier stage high-risk chronic lymphocytic leukemia.~   "
136417|NCT01269372|"~     This pilot, multi center study will establish the effectiveness of Given PillCam® Platform~     with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with~     polyps, compared to standard colonoscopy.~      This study will also use to evaluate the administrative feasibility and data management of~     study design.~   "
136418|NCT01269359|"~     Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards~     increased precision in the placement of implants. This trend requires an increased use of~     fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the~     operating room staff to radiation.~      Robotic assisted spine surgery is routinely performed in the authors' institution for a~     variety of indications such as degenerative conditions, trauma, tumors , infections and~     deformity correction11. The objective of this study is to compare the radiation exposure~     time during robotic guided vertebral body augmentation to the published results for similar~     surgeries.~   "
136419|NCT01269346|"~     This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin~     mesylate in combination with trastuzumab as first line treatment in female subjects with~     locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive~     breast cancer.~   "
136420|NCT01269333|"~     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute~     coronary events and coronary interventions. Several studies have shown that some patients~     are resistant to clopidogrel. The resistance mechanism is not entirely clear yet, but at~     least in part it is related to interactions between medications.~      Omeprazole is a member in the family of gastric proton pump inhibitor (PPI) that are widely~     used in patients who receive combination of aspirin and clopidogrel in order to protect the~     stomach lining and prevent GI bleeding. Data from studies on platelet aggregation indicate~     that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk~     for recurrent cardiovascular events in patients after coronary interventions. Recently the~     FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of~     reduction efficiency. Nevertheless there are several studies that do not support increased~     risk of cardiovascular events among patients taking omeprazole and clopidogrel, as the~     COGENT trial which is the single prospective controlled study that assessed the clinical~     implication of this drugs interaction.~      The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to~     create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole. fluvoxamine -~     is a member in SSRIs family and a potent inhibitor of the CYP2C19. In vivo studies compared~     the degree of decomposition proguanil (a CYP2C19 indicator) by fluvoxamine and omeprazole~     found constant inhibition- Ki = 10 Micromol / L for of Omeprazole versus constant~     inhibition- Ki = 0.69 Micromol / L for fluvoxamine. This indicates a more potent inhibition~     of CYP2C19 in vivo of fluvoxamine compared to omeprazole. It is important to note that so~     far there is no date in literature studies demonstrates that there is any interaction~     between fluvoxamine and other CYP2C19 inhibitors and Clopidogrel.~      Research goals:~        -  To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy~          individuals treated with clopidogrel.~        -  To verify weather the mechanism of omeprazole-clopidogrel interaction is related to~          CYP2C19 inhibition.~      Study design:~      Randomized blinded placebo-controlled crossover trial on healthy volunteers. The response to~     clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of~     the study drugs: fluvoxamine, omeprazole or placebo.~   "
136421|NCT01269320|"~     This is a Single -arm, open-label, before-and after exploratory trial of 90 days of~     Femarelle ® to improve NAFLD and the metabolic syndrome.~      Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome~     in patients suffering from these conditions.~      Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and~     will then be monitored off study treatment for an additional 4 weeks.~   "
136422|NCT01269307|"~     The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of~     propofol and ketamine is equivalent in complications, patient and physician satisfaction,~     post-procedure pain level, and procedural outcome to propofol sedation alone.~   "
136423|NCT01269294|"~     The purpose of this study is to evaluate the effect of TMC435 on the results of~     electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric~     recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis~     C virus infection.~   "
136424|NCT01269281|"~     The objective of this study was to compare the relative bioavailability of Sumatriptan~     Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult~     human subjects.~   "
136425|NCT01269268|"~     There was no sensitive and specific biomarker for tuberculosis infection, disease~     progression and predicting the prognosis of treatment. Therefore, the investigators aimed to~     investigate and evaluate the newer biomarker for the diagnosis of TB infection. To~     investigate the new biomarker for TB infection, the investigators will recruit the~     participants including active TB patients, healthy household contacts, healthy community~     control.~   "
136439|NCT01269086|"~     The purpose of this study is to determine whether a systematic family assessment in adult~     preventive health visits increases the detection of risk factors in the spouse or adolescent~     child of the screened person.~   "
136426|NCT01269255|"~     A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP)~     as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Radiation therapy was effectively used in~     esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied~     in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve~     survival and increase pathologic complete response in patients with gastric cancer.~     Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced~     tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced~     tumors.~   "
136427|NCT01269242|"~     The main study objective is to assess the efficacy and safety of different bindarit dosages~     compared to placebo in preventing restenosis, in patients submitted to coronary stenting and~     using a bare metal stent (Vision BMS, by Abbott).~   "
136428|NCT01269229|"~     The purpose of this study is the increase of resection rate of primary cancer in rectal~     after short course radiotherapy without interrupt chemotherapy schedule during the period of~     chemotherapy. The subject should have the pathologically confirmed for unresectable~     (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.~      This trial contributes to save the time for decreasing primary tumor in rectal and~     metastasis cancer to whole body after short course radiotherapy.~   "
136429|NCT01269216|"~     This is an open-label, randomized phase II study. Patients will be randomly assigned to~     either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients~     in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day~     for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be~     treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was~     administered orally twice a day after a meal on the day of irradiation (Monday-Friday)~     concurrent with radiotherapy.~   "
136430|NCT01269203|"~     The goal of this clinical research study is to learn if curcumin can reduce the symptoms~     reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.~   "
136431|NCT01269190|"~     The goal of this clinical research study is to learn if new imaging devices can help doctors~     decide if a lesion in the mouth is pre-cancerous or cancerous. The new imaging devices use~     different colors of light in mouth imaging.~   "
136432|NCT01269177|"~     The purpose of this study is to define the current treatment of patients ospitalized with~     acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency~     Department will used to investigate the primary outcome (mortality) and risk factors related~     to the primary outcome.~   "
136433|NCT01269164|"~     The purpose of this study is to apply human facial allograft transplant to the subjects with~     severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic~     appearance and functional outcome.~   "
136434|NCT01269151|"~     Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal~     function. No information besides visual acuity exist for the development of retinal function~     during the course of wet AMD during therapy with Lucentis. The aim of our study is to~     evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early~     predictor of recurrence of the disease. The second goal will be to evaluate the~     neuroprotective effects of an adequate therapy on retinal function using microperimetry and~     multifocal-ERG during the course of wet AMD.~   "
136435|NCT01269138|"~     FVII deficiency is a rare coagulation disorder. A limited number of patients are found in~     most treatment centres and countries. Treatment demands vary considerably amongst FVII~     deficient patients. Therefore, regular clinical studies will meet with recruitment problems~     in this particular patient population. The present study intends to elucidate the bleeding~     patterns in a well-defined collective of FVII deficiency patients who are carefully~     characterised, to document the actual use of different treatment modalities in different~     subgroups and to evaluate the efficacy and safety of current available treatment modalities~     in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge~     of treatment of patients with FVII deficiency - an area where treatment decisions are made~     more on personal clinical experience than on consolidated clinical evidence.~      This study intends to register treatment practices as they are actually performed - in a~     structured and documented way.~   "
136436|NCT01269125|"~     The investigators attempted to establish a rationale for the Gonadotropin Releasing~     Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild~     endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since~     GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003)~     and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators~     hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid~     and this action may improve the oocyte quality and the fertility of these women.~   "
136437|NCT01269112|"~     Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on~     account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive~     procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit~     (regional anticoagulation) has been advocated as the method of choice.However, citrate~     anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to~     citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis~     and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with~     frequent monitoring of acid-base and electolytes is also more challenging for the nurses and~     does not eliminate the need of a low-dose systemic anticoagulation for thromboses~     prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore~     mainly advocated only for patients at high-risk of bleeding.~      The investigators plan to implement an open-label randomized control trial assessing the~     effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI~     and with a special emphasis on the safety profile of this treatment in patients with severe~     liver failure.~   "
136454|NCT01268891|"~     To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by~     the change from baseline in mean total daily OFF time during 18 weeks of treatment in~     levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.~   "
136440|NCT01269073|"~     This trial is enrolling patients who are already being seen at OHSU sleep disorder center or~     have been referred for clinical reasons by their physician to the OHSU sleep disorder center~     and are going to have a sleep study that would be paid for by their insurance company for~     clinical reasons.~      The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher~     specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient~     population with a high predisposition to sleep apnea presenting to a sleep center.~   "
136441|NCT01269060|"~     Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single~     incision (Embryonic NOTES) colon surgery has been attempted.~      However, there are not sufficient evidences for single incision colon surgery in colon~     cancer.~      The investigators are researching the efficacy and safety of single incision laparoscopic~     sigmoidectomy in sigmoid colon cancer.~   "
136442|NCT01269047|"~     The main purpose of the study is to determine the effects of 16 weeks of adjunctive~     pramlintide or exenatide use on glycemic control in Type 1 Diabetes.~   "
136443|NCT01269034|"~     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal~     sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to~     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.~     This study is going to test whether this drug can improve the after meal sugars in people~     with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25~     mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group~     (healthy subjects) who do not get any medication before the boost. Insulin levels and other~     hormones that affect blood glucose as well as your sugar will be measured by a series of~     blood tests. The role exenatide as compared to insulin alone will be examined to prevent low~     blood sugars which might occur because of food staying longer in the stomach than usual or~     due to the suppression of a hormone called glucagon which increases blood sugar. If you~     qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone.~     You and the researchers will not know which dose you are taking at any single visit. A total~     of 20 people in which some will be children aged 12- 18 years will participate, being~     diagnosed within 3 months of having been found to have type 1 diabetes.~   "
136444|NCT01269021|"~     In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open,~     prospective, randomized parallel study to access the efficacy and safety of MMF compared to~     corticosteroid .~      Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the~     MMF group or corticosteroid group.~   "
136445|NCT01269008|"~     Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting~     insulin therapy. Furthermore, this occurs even in the setting of the closed loop system.~     Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot~     respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes,~     there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate~     post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the~     etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial~     hyperglycemia in diabetes. With this protocol, the investigators would like to optimize~     treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the~     process also optimize the insulin algorithm.~      This is a paired, randomized, and controlled comparison of pramlintide and insulin versus~     exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin~     delivery.~      The investigators will stratify the study subjects into the following sub-groups of 5~     subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old.~     The investigators would also begin the study with the 21-25 year patient sub-group and then~     transition to the other sub-groups after evaluating all the safety issues. 22-30 year old~     ones would be considered as an adult subset, 18-21 year olds would be considered pediatric~     subset according to the guidelines of FDA's Center for Devices and Radiological Health~     (CDRH) and 16-18 year olds are considered typical pediatric population. At this time,~     Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not~     have any literature in Spanish that may used in explaining the study to this group of~     patients. When in the future Medtronic is able to provide us with the appropriate Spanish~     literature, the investigators will at that time amend the protocol to include this group of~     subjects.~   "
136446|NCT01268995|"~     New onset diabetes after transplantation (NODAT) is a frequent and feared complication after~     kidney transplantation and leads to an increase in cardiovascular complications as well as~     in the rate of graft loss. Very little data exist on how patients in which NODAT has been~     diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less~     diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early~     initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the~     function of the insulin secreting cells in the pancreas. Therefore, the investigators test~     the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed~     NODAT who have just started early treatment with insulin. The hypothesis is that patients~     who are treated with insulin and who are switched to Cyclosporine A have improved glucose~     metabolism compared to patients who are treated with insulin and who remain on Tacrolimus~     therapy.~   "
136447|NCT01268982|"~     In this study, the investigators will evaluate the dimensional changes of alveolar bone in~     the preserved sites in comparison with extraction only conventional healed sockets, as well.~        1. Dimensional changes of the alveolar ridge contour after socket preservation in~          comparison to conventional tooth extraction.~        2. Evaluation the stability of implants placed at the preserved sockets.~        3. Histological evaluation of newly formed bone at the socket preserved sites in~          comparison with extracted only healed sites.~   "
136448|NCT01268969|"~     Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.~   "
136449|NCT01268956|"~     Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis~   "
136450|NCT01268943|"~     The purpose of this study is to seek the proper dose of capecitabine in post-operative~     concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical~     surgery, and evaluate the toleration of this modality in such patients.~   "
136451|NCT01268930|"~     In this study, impacts of hemostatic matrix and bipolar electrocoagulation on ovarian~     reserve in women undergoing ovarian endometrioma excision are compared.~   "
136452|NCT01268917|"~     Antiplatelet therapy is critical in the management of coronary artery disease.For patients~     undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of~     preoperative antiplatelet therapy.And there is little study about the effect of continuing~     aspirin until the surgery day on graft patency.So we would like to perform this study to~     evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump~     coronary bypass.~   "
136453|NCT01268904|"~     To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus~     and acute repetitive seizures as part of seizure treatment protocol in pediatric ER~   "
136456|NCT01268865|"~     Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for~     hazard evaluation of future disease complication development and thus for the optimal~     decision making on treatment selections.In the era of antiviral and antifibrotic treatments,~     clinical and research demands are also increasing for non-invasive surveillance of liver~     fibrosis to evaluate the progression or regression. However, local baseline data on liver~     stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral~     hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to~     the aims to recruit patients based on strict but appropriate criteria, to complete the~     correlation and validity studies between ARFI quantification and the referenced METAVIR~     fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials~     and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient~     immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring~     during the same session of examination. Statistics: The first year's study using ARFI will~     focus on the correlation testings and validity studies using receiver operating~     characteristics.~   "
136457|NCT01268852|"~     The hypotheses tested in this study are: There is a statistical significant difference, in~     treatment duration and result of treatment in cases treated using traditional Damon Q~     brackets or using Insignia.~   "
136458|NCT01268839|"~     The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25~     mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily~     in healthy volunteers~   "
136459|NCT01268826|"~     The aim of the study is to determinate the prevalence of moderate dehydration among children~     aged 9 to 11 who are going to school.~   "
136460|NCT01268813|"~     The metabolic syndrome is a collection of related risk factors that predispose to the~     development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will~     examine the hypothesis that the metabolic and genomic characteristics of patients with~     metabolic syndrome and/or diabetes that are at risk for developing complications differ from~     each other and can be detected using specific biomarkers in blood or in the exhaled breath.~     Early detection of these individuals will enable personalized treatment to prevent and treat~     diabetes and its complications~   "
136461|NCT01268800|"~     Personalization of AML therapy, require a reliable mechanism for accurate characterization~     of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype~     or in practical clinical term, patient's leukemia sensitivity to induction therapy, should~     best investigated in-vivo during induction. Elimination of circulating leukemic blasts from~     peripheral blood by day 5 was shown to discriminate between good responders with superior~     long term survival and poor responders with poor outcome. However, many AML patients have no~     circulating blasts at diagnosis and even in those who have, elimination rate of it from~     peripheral blood was never correlated with actual response in bone marrow.~      Currently, the only available source for patient's specific leukemia profile, is the bone~     marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple~     different clones, on diagnosis marrow consist a spectrum of chemotherapy sensitive and~     resistance clones. Clones may vary by their molecular abnormalities and results from on~     diagnosis marrow may overlook minor resistant but existing clones. Long term prognosis is~     determined by those resistant clones and though our interests should be focused into the~     abnormalities of these clones. Residual blasts on day 5 marrow may better represent the~     profile of patient's leukemic resistant clones.~   "
136462|NCT01268787|"~     This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine~     at a 0.25ml or 0.5ml dose in health volunteers~   "
136463|NCT01268774|"~     Patients with multiple myeloma have seen their survival rate strongly improved with the use~     of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or~     lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT~     however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE)~     up to 20%. In these conditions, a prevention of this risk can be proposed by physician with~     either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending~     the new recommendations on the management of VTED, the purpose of this study is to describe~     in real life conditions the management by oncologists of the thrombo embolic risk for such~     patients~   "
136464|NCT01268761|"~     The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of~     early ovarian hyperstimulation syndrome.~   "
136465|NCT01268748|"~     This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain~     than conventional laparoscopic cholecystectomy.~   "
136466|NCT01268735|"~     Purpose To try to establish whether lid-parallel conjunctival folds (LIPCOF) can be~     influenced by increased lubrication with rewetting and lubricating eyedrops containing~     hydroxypropyl-guar, which has proven lubricating effect.~      Methods During summer and fall of 2009, 16 ophthalmologists from various regions of Croatia~     investigated the effect of topical therapy with lubricating eyedrops on the signs and~     symptoms of dry eye, with the special emphasis on lid-parallel conjunctival folds (LIPCOF).~     229 patients were enrolled in the study.~      Results After 14 days of therapy with lubricating eyedrops containing hydroxypropyl-guar,~     statistically significant reduction of LIPCOF grade was observed, as well as the reduction~     of symptoms and other signs of dysfunctional tear syndrome (TBUT, Schirmer test,~     conjunctival hyperemia).~      Conclusion Results of this study have shown positive influence of lubricating eyedrops~     containing hydroxypropyl-guar on signs and symptoms of dysfunctional tear syndrome even~     after only 14 days of treatment. It is of particular interest that LIPCOF grade was~     statistically significantly decreased, pointing at increased friction and decreased ocular~     surface lubrication as possible causes of its appearance.~      Having this in mind, every clinician involved in dysfunctional tear syndrome treatment must~     also think about lubrication as integral part of treating this condition.~   "
136467|NCT01268722|"~     This is a multicenter double-arm randomized trial investigating plain balloon angioplasty~     versus primary placement of self-expanding nitinol stents after endovascular recanalization~     of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for~     detection of a significant difference in vessel patency after 1 year.~   "
137198|NCT01259167|"~     The purpose of this study was to assess whether a training program based on Joba® Core~     Trainer is effective in reducing pain and improving physical function and quality of life of~     subjects suffering from Chronic Low Back Pain.~   "
136468|NCT01268709|"~     The objective of this randomized triple blind controlled trial is to compare the effects of~     Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75~     patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a~     tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete~     evacuation, and bloating are measured and compared between groups at the baseline and one~     and two month after the intervention.~   "
136469|NCT01268696|"~     Metabolic syndrome is a combination of medical disorders that increase the risk of~     developing cardiovascular disease and diabetes. The exact mechanisms of the complex pathways~     of metabolic syndrome are not yet completely known. The pathophysiology is extremely complex~     and has been only partially elucidated. Most patients are older, obese, sedentary, and have~     a degree of insulin resistance. Stress can also be a contributing factor. The most important~     factors are:~      weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will~     assess the role of some polymorphisms in the pathology of metabolic syndrome.~   "
136470|NCT01268683|"~     The study objective is to assess the feasibility of enrolling, evaluating, and treating with~     RP-1127 (Glyburide for Injection) severe anterior circulation ischemic stroke patients,~     whether or not treated with standard of care IV rtPA. Patients must be between 18-80 years~     of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 - 210 cm3, and~     time from symptom onset to start of study infusion must be ≤10 hr.~   "
136471|NCT01268670|"~     Background Approximately 30 million children are treated in emergency departments each year~     in the United States, of which two to three million are children presenting with~     lacerations. Topical numbing medication is the standard of care in children with regard to~     pain control during laceration repair. While topical numbing medications are effective,~     children often require further pain control during laceration repair in the form of an~     injected numbing medication, which in itself is painful. No evidence currently exists~     regarding the concurrent use of oral pain medications to combat laceration procedural pain.~      Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and~     tetracaine (LET) topical anesthetic provide more effective pain control than LET alone~     during laceration repair?~      Design This is a double-blinded, randomized-controlled study.~      Methods Subjects in all three groups will receive topical anesthetic. In addition to topical~     anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or~     oxycodone, while the third group will receive a placebo.~   "
136472|NCT01268657|"~     The purpose of this study is to determine whether a brief intervention for disabling anxiety~     is practical to conduct and beneficial for older adults injured by falls.~   "
136473|NCT01268644|"~     This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with~     the aim of lowering the total insulin requirements and suppressing the steep fluctuations~     typically associated with Type 1 Diabetes.~   "
136474|NCT01268631|"~     Hypothesis:~      Response to therapy in fibromyalgia can be improved by coupling of specific medications to~     the individual patterns of dysfunctional pain modulation. Individuals exhibit wide range of~     pain modulating capabilities that can be assessed by dynamic psychophysical testing. Those~     that exhibit less efficient endogenous analgesia and/or increased pain summation are known~     to be more prone to suffer from pain. Tailoring medications to compensate for the specific~     dysfunctioning modulatory mechanism will improve pain control.~   "
136475|NCT01268618|"~     Primary Objective:~      • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev~     Trio (professional label) in the improvement of symptoms in adult patients with~     diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia~      Secondary Objective:~      • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio~     (professional label) in adult patients with IBS-D and functional dyspepsia~   "
136476|NCT01268605|"~     Postoperative hypersensitivity (POH) is a problem for many patients as determined by the~     recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following~     occlusal caries restoration. The objectives of this two-armed randomized comparative~     effectiveness research trial (RCERT) are to determine whether adding a resin modified glass~     ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC)~     restorations, and to identify other factors (putative risk factors) that are associated with~     increased POH.~      The primary outcome of this study is the reduction/elimination of restoration POH as~     measured by clinical assessment (air stream) and patient-reports.~      Outcomes will be ascertained via the following specific aims:~      Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical~     measurement (air drying) and by patient-reported outcomes among the two treatment groups at~     three points in time: prior to restoration and at one and four weeks postrestoration.~      Specific Aim 2: To identify putative risk factors for POH (or factors associated with~     differences in POH) including: preoperative caries stage measured by the proposed American~     Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the~     preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation~     depth, and patient sleep bruxism status.~   "
136477|NCT01268592|"~     The purpose of this study is to preserve the fertility potential in females diagnosed with~     cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for~     their cancer.~   "
136478|NCT01268579|"~     Human papillomavirus (HPV-16) is an important factor in the development of many tonsil~     and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer~     by itself, it appears to contribute to the development of tonsil and/or base of tongue~     cancer in many patients. It is likely that treatment for many patients with tonsil and/or~     base of tongue cancer could be improved if effective therapy to control HPV-16 is developed.~     The investigators in this study want to learn if ribavirin shows evidence of activity~     against HPV-16.~      Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as~     part of the standard treatment for Hepatitis C. Laboratory experiments suggest that~     ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin~     has not yet been tested against head and neck cancer in patients. The purpose of this study~     is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in~     patients.~      The main purpose of this study is to see if ribavirin changes the expression of certain~     proteins related to HPV infection in the tumor. The study will also find out if ribavirin~     changes how the tumor appears in a PET/CT scan (positron emission tomography/computed~     tomography scan).~   "
136486|NCT01268475|"~     Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial~     tree due to repeated cycles of inflammation and infection, resulting in progressive loss of~     lung function. The surgical treatment by pulmonary resection or even lung transplantation is~     indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment,~     or when associated with serious complications. There are few literature data on the~     influence of bronchiectasis in exercise capacity, quality of life and functional capacity,~     and the impact of lung resection in patients with this diagnosis. The primary objective of~     this study is to evaluate prospectively the impact of lung resection on exercise capacity in~     patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective~     of this study is to evaluate the impact of lung resection on quality of life and lung~     function and to analyze the the presence of predictors of postoperative functional~     deterioration and the occurrence of complications.~   "
136487|NCT01268462|"~     In patients with obstructive lung disease like asthma aerosol therapy is the most used for~     drug administration. A order to make better use of aerosolized drugs in asthmatic patients,~     studies focus on ways to optimize this administration. Objective: To evaluate the efficacy~     of nebulized bronchodilators carried by heliox associated with positive expiratory pressure~     (PEP) in lung deposition of radiation activity in adult asthmatic patients between episodes~     and its impact on lung function. Methods: A randomized controlled trial involving 32 with a~     mean age of 47.28 ± 9.67 of which 25% of the sample are male, these patients were divided~     into four groups: heliox + PEP, + PEP oxygen, heliox and oxygen in Regarding the~     anthropometric characteristics, parameters and cardiopulmonary baseline spirometry data were~     similar for all groups. For inhalation lung scintigraphy was used a noninvasive delivery~     system - orofacial mask with two unidirectional valves nontoxic - inspiratory and expiratory~     branch - connected to the nebulizer for radioisotopes associated with PEP of 10 cm H2O. At~     the end of inhalation, the images were acquired in a scintillation camera at 0, 15, 30, 45~     and 60 min. In order to analyze the aerosol deposition in different lung areas were~     delineated regions of interest (ROIs) in the vertical - the upper, middle and bottom - and~     horizontal central, intermediate and peripheral. Results: The spirometric data showed an~     increase in the values of forced expiratory volume in one second (FEV1) predicted when~     compared with the heliox group + PEP (80%, p = 0.030) with PEP + O2 (65%, p = 0.030). As for~     CI, there was also an increase in PEP + heliox group (0.05 L, p = 0.012) compared to groups~     without oxygen and heliox PEP (0.03 L, 0.03 L, p = 0.012 respectively) for the total number~     of counts, no differences were seen between groups with heliox and oxygen with PEP PEP~     (482510, 577598, p = 0.262 respectively) for the total number of counts by comparing the~     oxygen group + PEP (577,598) with the heliox group (332,951, p = 0.004) and oxygen without~     PEP (409,526, p = 0.045), there was a greater number of counts in the O2 + PEP group. By~     analyzing the rate of pulmonary deposition (IDP) in the vertical gradient, higher deposition~     in the middle third (p = 0.001) when compared to upper and lower in both groups. With regard~     to IDPs in the horizontal gradient, there was greater deposition in the intermediate region~     when compared to central and peripheral (p = 0.003, 0.001 respectively) in all groups. As~     the penetration rate, no significant differences between groups (p = 0.726). When~     considering the pulmonary clearance, decreased with the number of counts over time within~     groups (p <0.05) but no differences between them: heliox + PEP (20.67%), PEP + oxygen~     (13.50%), heliox (16.27%) and oxygen (16%) - (p> 0.05). Conclusion: Although no differences~     in the rate of penetration and clearance of pulmonary radiation activity between groups, we~     noted a higher number of counts in patients who underwent nebulization with oxygen~     associated with PEP and a functional improvement in patients who underwent nebulization with~     PEP as spirometric values and CI.~   "
136488|NCT01268449|"~     The purpose of this study is to determine wether low dose laser is effective on idiopathic~     subjective tinnitus.~   "
136489|NCT01268436|"~     Toothache is a common source of pain for Emergency Department patients. There are several~     common ways to control the pain of toothache. But we do not know if any one of them is more~     effective than another. It is also possible that how we take care of your pain in the~     Emergency Department will influence the level of pain you experience one or two days from~     now. This study seeks to answer these questions.~   "
136490|NCT01268423|"~     The aim of the study is to determine if performing an early tracheostomy (within the first 4~     days of endotracheal intubation) in critically ill patients on mechanical ventilation,~     reduces the incidence of swallowing dysfunction.~   "
136491|NCT01268410|"~     Acute respiratory failure is a common entity in intensive care units nowadays and is~     associated with significant morbidity and mortality, thus representing a major health~     problem. Most of the published epidemiological studies on this condition were performed when~     modern ventilatory strategies and non-invasive ventilation were not available. Therefore, an~     actual evaluation on the incidence and outcomes of this syndrome is mandatory. We will~     perform an observational prospective study of patients admitted with acute respiratory~     insufficiency in several ICUs in Brazil.~   "
136492|NCT01268397|"~     The purpose of this study is to examine whether operation and fixation with a metal plate~     gives better result from the patient's perspective than plaster treatment in elderly~     patients with a displaced wrist fracture.~   "
136493|NCT01268384|"~     The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus~     capecitabine for patients with LAPC includes the following: First, obtaining a sufficient~     tumor down-staging to procure R0/R1 resection, reported to be one of the most significant~     prognostic factors for survival; second, providing an observation period to exclude from~     surgery those patients with rapidly progressive disease there by to help select patients for~     surgery who have the greatest likelihood of a favorable postoperative outcome; third,~     eliminating micrometastatic disease, that is likely present in most patients, earlier than~     adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given~     in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a~     major operation; and the last, the lack of widely accepted optimal preoperative or~     palliative approach in patients with LAPC, the majority of whom may not be operated on.~      The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate~     (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline~     resectable or unresectable locally advanced pancreatic adenocarcinoma.~      The secondary goals are to assess progression-free survival (PFS) and OS (overall survival)~     in these patients and to assess adverse events of these neoadjuvant treatments.~   "
136494|NCT01268371|"~     To compare the safety and efficacy of coronary stenting with everolimus-eluting stent~     (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)~   "
136495|NCT01268358|"~     This is a single-center, open-label, dose escalation study of patients with~     alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous~     infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients~     will continue weekly treatment at the designated dose until the Safety Committee approves~     transfer to the rhLAMAN-03 protocol.~      It is the hypothesis that Lamazym is safe to use.~   "
136496|NCT01268345|"~     Blood glucose monitoring system are tested in the alternative site to validate the accuracy~     of the blood glucose.~   "
136497|NCT01268332|"~     The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR~     in HIV uninfected women over 12 weeks of use.~   "
137593|NCT01254006|"~     In this study the investigators are going to study the retinal nerve fibers layers (RNFL)~     modification of two groups of patients, one taking no drugs, the other taking forskolin,~     rutin and vitamins B1 and B2.~   "
136498|NCT01268319|"~     The CANARY (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow)~     Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is~     at high risk of rupturing during standard of care therapy and causing intra-procedural~     complications. If plaques that require treatment are at higher than normal risk of causing~     intra-procedural complications, some life threatening, the treating physician is better~     informed and may opt to take precautionary measures to mitigate the risk or result of a~     complication. The CANARY Study is also designed to evaluate the feasibility of using a~     distal embolization protection device (EPD) as a means to prevent heart attacks triggered by~     the embolization of plaque during standard care therapy. It is thought that the EPD will~     prevent plaque from going downstream during treatment and obstructing other heart vessels.~     These obstructions could cause heart attacks by preventing blood from reaching heart muscle~     tissue.~   "
136499|NCT01268306|"~     Corneal epithelial disruption, commonly termed corneal staining has been frequently~     associated with contact lens wear. Previous research has demonstrated higher levels of~     observed corneal staining when certain combinations of contact lenses and lens care products~     are used, particularly under daily wear regimens. B+L lenses made from Balafilcon~     (PureVision) have been associated with the highest rates of observed staining. Additionally,~     polyhexamethylene biguanide (PHMB) based lens care products, specifically B+L ReNu MultiPlus~     have been implicated in higher rates of staining. In general, many lenses constructed from~     newer, silicone hydrogel (SiHy) materials appear more susceptible to increased rates and~     amounts of corneal staining.~      Although the clinical significance of staining is debated, most clinicians agree that less~     staining is preferable to greater amounts of staining. Advances in understanding as well as~     the specifics of lens care product formulation ideally will have resulted in design of newer~     products that minimize corneal staining and maximize product performance. This study will~     examine rates of corneal staining using B+L's recently introduced lens care product: BioTrue~     with the B+L PureVision lens which has previously been associated with the highest levels of~     staining.~   "
136500|NCT01268293|"~     The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg~     when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1~     cycle) in subjects with solid tumors~   "
136501|NCT01268280|"~     The primary objective of this early-stage clinical study is to demonstrate an effect of~     single doses of CK-2017357 on measures of skeletal muscle function and fatigability in~     patients with generalized myasthenia gravis (MG).~   "
136502|NCT01268267|"~     The purpose of this study is to evaluate the performance and acceptability of an~     investigational blood glucose monitoring system, which includes meter and sensor strip.~   "
136503|NCT01268254|"~     The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men~     from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric~     measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial~     flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length.~      The sample size has been calculated expecting that regular red wine ingestion would lead to~     a five year old younger vascular ageing indexes measured by carotid intimal media thickness,~     coronary artery calcium scores and leucocyte telomere length longer than those abstainers~     subjects at same age.~      The investigators hypothesized that regular wine consumers present less coronary lesion and~     coronary calcium score on coronary tomographic angiography, lower carotid intimal media~     thickness and higher mean telomere length due the benefice of wine.~   "
136504|NCT01268241|"~     The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There~     are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and~     Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a~     confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been~     commercially available in Europe for almost 10 years, yet little information is available~     about the clinical and safety profile of patients who switch from one therapy to the other.~     An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large~     number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study~     the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal®~     on a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many~     of these patients received a reduced dosage of Fabrazyme® for an extended period before~     transitioning to treatment with Replagal®.~   "
136505|NCT01268228|"~     The coronary bifurcation lesions pose a therapeutic problem with high rates of~     periprocedural complications, higher rates of in-stent restenosis and stent thrombosis.~     These are lesions where stenting is not superior in comparison to balloon angioplasty in~     regard to side branch. It was demonstrated many times, in literature and in daily practice,~     that angiographically high grade ostial side branch stenosis is not flow limiting and do not~     cause ischemia, therefore do not require treatment. From the other side, our own data with~     MRI before and after bifurcation PCI demonstrated that occurrence of angiographic stenosis~     more than 70% in diameter is associated with periprocedural myonecrosis in the region of~     side branch. This fact puts a very important question about the mechanisms of this~     myonecrosis. If the jailed side branch has no significant flow limiting stenosis, but there~     is some degree of residual ischemia, which after some period of persistence could lead to~     myonecrosis, will mean that more aggressive treatment of ostial stenosis is needed. It is~     interesting that the strategy of treatment is very important, because techniques with second~     stent implantation (with primary purpose to limit SB ischemia) are associated with higher~     grade of troponin increase. Of course this is association and not causality, despite that in~     randomized study (NORDIC I) it was confirmed also.~      It is without explanation the fact of rare occurrence of significant (flow limiting, FFR~     <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than~     75%) and almost 50% periprocedural myonecrosis detected in the side branch areas. One~     working hypothesis is that stent implantation and related episode of ischemia induces~     prolonged vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be~     non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia~     could persist is small areas for which available flow is not sufficient despite that global~     regional flow is deemed sufficient. It is also possible that those patients have not enough~     recruitable collaterals. It is also possible that both factors act together.~      Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it~     cannot give information as to whether this ischemia may be clinically significant or not,~     i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that~     FFR may not be useful in predicting clinically meaningful ischemia in a specific side branch~     vessel.~      The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia~     detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and~     easy to register. The wire tip could be positioned directly in different regions and thus to~     map regional ischemia. In most of the studies and from our own observations became evident~     that when surface ECG do not react the i.c. ECG demonstrates significant changes in~     ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs~     only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate~     residual ischemic changes in distal main vessel and side branch as sources of prolonged~     ischemia, respectively - source of periprocedural myonecrosis.~      The objective of this study is to evaluate the clinical significance of side branch vessel~     by occluding the blood flow with a 1-minute balloon occlusion. We will also assess whether~     there is any change in ECG (i.c. and 12-lead surface records) on balloon occlusion and~     relation with periprocedural myonecrosis.~   "
136506|NCT01268215|"~     A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of~     pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic~     treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low~     birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the~     tracheal aspirate before and after instillation of the study drugs.~   "
136507|NCT01268202|"~     Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since~     10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis~     (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular~     mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors~     inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and~     ex vivo in human samples. In addition, the curative administration of Pravastatin improves~     established RIF in vivo. The investigators data suggest that the pravastatin-based strategy~     is an efficient and safe antifibrotic therapy, easily transferable into the clinic to~     improve the quality of life of long-term cancer survivors without interfering with prior~     anticancer treatment.~      This clinical trial evaluates the curative efficacy of Pravastatine in patients who~     presented a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4~     toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients~     will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by~     ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients~     assessment will be performed at 6 and 12 months after the end of the treatment to look at a~     potential rebound effect.~      Objective(s) of the clinical study~      Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous~     radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.~      Second objective: To evaluate radio-induced fibrosis regression during the year following~     treatment stop.~   "
136509|NCT01268176|"~     This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in~     the presence of a meal and if the enhancement will be greater when the meal is low as~     opposed to high in fat content. The enhancement will result from increased vitamin D~     absorption. The investigators will test this hypothesis by pursuing the following aims in a~     3-mo trial in which up to 70 healthy men and women will be randomized to one of the~     following meal conditions under which they will take a monthly oral dose of 50,000 IU of~     vitamin D3: no meal (fasting), a low fat meal, or a high fat meal. The Primary Aim is to~     identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3~     response to supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to~     determine whether vitamin D3 absorption is affected by the meal condition and to determine~     whether the absorption of vitamin D3 predicts the longer-term 25OHD3 response to~     supplementation.~   "
136510|NCT01268163|"~     The purpose of this study is to compare the pharmacokinetic and safety characteristics of~     European Taxotere® and American Taxotere® with Hospira Docetaxel injection in patients with~     cancer.~   "
136511|NCT01268150|"~     The purpose of this study is to assess the efficacy and safety of single-agent eribulin~     mesylate for first-line treatment of subjects with locally recurrent or metastatic breast~     cancer.~   "
136512|NCT01268137|"~     This study aims at assessing efficacy and safety of DBS for treatment of patients suffering~     from resistant major depression, by means of a random, controlled and crossed study.~   "
136513|NCT01268124|"~     This is a phase 1, randomized (a process that is used to decide whether you will take study~     drug or a placebo during the study), inpatient study which will assess the safety and~     tolerability of HTC-867 in healthy male Japanese subjects.~   "
136514|NCT01268111|"~     Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D~     replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before~     and after the intervention, and the changes will be compared between the two groups. This~     will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol~     Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are~     mediated by RBP4.~   "
136515|NCT01268098|"~     Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults~     with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and~     vitamin D supplements.~   "
136516|NCT01268085|"~     In recent years, multiple articles have highlighted the increased risk of developing cancer~     from ionizing radiation. The risk increases with higher radiation doses, and accumulates~     with repeated scans.~      Hospitals with computerized physician order entry systems (CPOE) have the unique opportunity~     to use decision support on radiation safety to influence a physician's ordering practice in~     real-time. An ideal decision support tool for radiation safety will educate the physician~     about the dangers of cumulative ionizing radiation, present the patient's image history, and~     guide the provider to the best modality that meets the patient's diagnostic needs with as~     little radiation exposure as possible. The design challenge is to create a decision support~     tool that appropriately protects the investigators patients from overutilization of CAT~     scans, without inadvertently leading to underutilization of CAT scans or inappropriate~     utilization of alternative tests.~      This research protocol proposes to study one such design at a large, academic medical~     center.~   "
136517|NCT01268072|"~     The primary objective of this study is to identify biomarkers that can be used for~     evaluation of efficacy in subjects presenting with AECOPD~   "
136518|NCT01268059|"~     The purpose of this study is to evaluate the dose, antitumor activity, safety and~     pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with~     previously untreated, advanced non-small cell lung cancer (NSCLC).~   "
136519|NCT01268046|"~     This study will focus on how aging affects changes in the way the brain works when affected~     by estrogen in areas of the brain associated with memory.~   "
136520|NCT01268033|"~     Background~      Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with~     immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).~      Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with~     failure or toxic side effects of other immunosuppressant treatments is a major matter of~     concern.~      Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this~     treatment for years. At the same time, low doses of cyclosporine allow proteinuria to~     reappear, which provokes degradation of renal function by focal segmental~     glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective~     in such a disease, with a cyclosporin sparing effect.~      Purpose~      The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the~     treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic~     syndrome.~      Abstract Patients will be included in the study in a period of remission of proteinuria. Two~     infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one~     week of interval. Other immunosuppressant treatments will be gradually tapered off with the~     same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding~     code will be broken. Rituximab will then be infused to patients having received placebo.~   "
136521|NCT01268020|"~     The underlying goal of this study is to assess [18F]-FMH3 PET imaging as a tool to evaluate~     the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants~   "
136522|NCT01268007|"~     This is an observational, un-blinded, non-significant risk, non-interventional study~     designed to collect ECG data on at least one subject out of a pool of up to three (3)~     healthy male subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be~     collecting ECG recordings collected by an investigational device for comparison with~     conventional ECG recordings. This data will be used to validate a new device under~     development.~   "
136523|NCT01267994|"~     The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist)~     can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED)~     that did not respond to oral steroid therapy for a sudden decline in hearing. The patients~     to be enrolled will have recently completed a course of oral steroids and demonstrated no~     change in their audiometric thresholds following corticosteroid therapy.~   "
136525|NCT01267968|"~     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that~     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with~     tRNA and is currently in development for the treatment of hospital acquired Gram-negative~     infections (including E. coli, K. pneumoniae, and Enterobacter spp.).~      This is an open-label, randomized, single period, parallel-cohort pharmacokinetic study to~     evaluate serum and pulmonary pharmacokinetics following single dose and multiple dose~     administration of intravenous GSK2251052. In Cohort 1, approximately 15 healthy adult~     subjects will be randomized to receive a single IV dose of GSK2251052 1500 mg in the fasted~     state. Following the dose, bronchoalveolar lavage (BAL) fluid and serial plasma samples will~     be collected for determination of GSK2251052 parent and metabolite concentrations. In Cohort~     2, approximately 15 healthy adult subjects will receive GSK2251052 1500 mg IV BID x 5 doses~     (Cohort 2). Following the last dose in the fasted state, bronchoalveolar lavage (BAL) fluid~     and serial plasma samples will be collected for determination of GSK2251052 parent and~     metabolite concentrations. Vital signs, ECGs, and adverse events will be monitored~     throughout the study. A follow up visit will occur 10 to 14 days after the last dose of~     study drug.~   "
136526|NCT01267955|"~     This phase II trial studies how well vismodegib works in treating patients with~     chondrosarcomas that have spread to other places in the body and usually cannot be cured or~     controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
136527|NCT01267942|"~     Null hypothesis; The efficacy of Enhancin]Co-Amoxiclav given as a single intravenous dose at~     induction is not better than a five days oral course of the same given postoperatively in~     reducing postoperative morbidity after adenotonsillectomy.~   "
136528|NCT01267929|"~     This study aimed to develop Video Compact Disc (VCD) program that applying the concept of~     imitative learning with mirror neurons stimulation on standard rehabilitation technique in~     children with cerebral palsy. The author will also examine effectiveness of the program by~     compare the motor function measured by the gross motor function measure (GMFM-66) between~     conventional physical therapy and the mirror neurons stimulation based VCD program for six~     months.~   "
136529|NCT01267916|"~     It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive~     end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine~     position. The investigators tried to investigate the effect of low respiratory rate and high~     tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general~     anesthesia.~   "
136530|NCT01267903|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children~     caused by viruses that belong to the enterovirus genus of the picornavirus family. Although~     most HFMD cases do not result in serious complications, outbreaks of HFMD caused by~     enterovirus 71 (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused~     by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The development of vaccine against EV71 is active and ongoing in Asian countries now.~     Several studies have examined the effectiveness of inactivated viral vaccines against EV71~     in animal model. A wide range of experimental EV71 vaccine approaches have been studied~     including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles~     (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the~     neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live~     attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as~     one of the most important factors in prevention of the severe EV71 infection. Recently, an~     inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this~     clinical trial phase Ia is armed to evaluate safety and tolerance in Chinese healthy adults~     and children.~   "
136531|NCT01267890|"~     This study is a prospective cross-sectional survey study. The investigators developed~     self-administrated questionnaire and recruit 120 physicians in two hospitals and 60 lawyers~     from some law firms to this study.~      To realize and compare the opinions of physicians and lawyers about controversial~     decision-making of surrogate.~   "
136532|NCT01267877|"~     The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines~     for breast cancer screening for women in their 40's and assess the effect of one of two~     newspaper articles on their attitudes. The population studied was women seeing their private~     gynecologist for annual exams in the 39-49 year old age group.~   "
136533|NCT01267864|"~     This randomized study is testing 3 different intravenous medications to see which one is~     best for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.~   "
136534|NCT01267851|"~     The database and biobank establishment started in 1997 in our institute. However, the sample~     size was too small with respect to our clinical and fundamental scientific research's~     requirement. Thus the Chinese gynecological oncology study (GOS) group was established to~     create a large multicentre database and biobank of patients with gynecologic diseases.~   "
136544|NCT01267721|"~     It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal~     circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion~     related oxidative stress which could further lead to the development of organ failure in~     critically ill patients. Perioperative levels of macrophage migration inhibitory factor~     (MIF) and other inflammatory mediators could be involved in adverse outcomes in cardiac~     surgery.~   "
136545|NCT01267708|"~     The purpose of this study is to examine PLT function in PCI patients.~   "
136546|NCT01267695|"~     Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the~     chance of relapse after surgery. This phase II trial is studying the effectiveness of~     perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal~     stromal tumor.~   "
136547|NCT01267682|"~     The purpose of this study is to test the effectiveness of cognitively stimulating activities~     for resolving delirium in people with dementia.~   "
138434|NCT01242956|"~     The study hypothesizes superiority of the video-based training (observation combined with~     motor exercise, video) over motor exercise alone (non-video) and standard rehabilitation~     (standard).~   "
136535|NCT01267838|"~     BBK- 2 - study:~      STUDY-SUMMARY~      Background:~      The need for stenting of the main and side branch (double stenting) in the treatment of~     coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion.~     If the bifurcation lesion is very complex (Medina classification 111, severe stenosis of~     both branches, severe calcified lesion, long lesions etc.) double stenting may be the~     treatment of choice. When double stenting is required, the most frequently used stenting~     techniques are T-stenting and Culotte-stenting. It is still unclear, however, which double~     stent technique yields the best long-term outcome.~      Aim:~      This randomized study will compare the long-term safety and efficacy of T-stenting versus~     Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting~     stents.~      Methods:~      Three-hundred patients in whom a double-stenting technique is intended for the treatment of~     a de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or~     Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month~     angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed~     at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is~     the maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary~     endpoints include binary restenosis (estimated by Quantitative Coronary Angiography (QCA)~     analysis), Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events~     (MACE) and the rate of stent thrombosis according to the definition of the Academic Research~     Consortium (ARC definition). The study will have 90% power to detect a 25% reduction in the~     primary endpoint at p < 0.05.~   "
136536|NCT01267825|"~     Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe~     that it is functionally disabling. The purpose of this randomized clinical trial is to~     determine if corticosteroid medication, delivered directly to the area near the herniated~     disc, can improve the pain and functional disability associated with a herniated disc.~   "
136537|NCT01267812|"~     RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Giving~     bortezomib together with rituximab may kill more cancer cells.~      PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together~     works in treating patients with mantle cell lymphoma who have previously undergone stem cell~     transplantation~   "
136538|NCT01267799|"~     Photocopiers are indispensable in today's working environment. However, photocopiers emit a~     number of harmful chemicals during their operation. Photocopier toners also contain a number~     of potentially toxic substances. Chronic exposure to these substances may compromise the~     health of photocopier operators. This study is aimed to understand if chronic exposure to~     photocopier emissions is harmful to human health.~   "
136539|NCT01267786|"~     The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic~     function after ischemic/reperfusion injury and the sequence influence on renal and~     cardiovascular systems.~   "
136540|NCT01267773|"~     Having both depression and conduct problems at the same time has been found to be associated~     with increased risk for the other and increased risk of negative outcomes. This study will~     develop an family based cognitive behavioral treatment protocol for youths with both conduct~     problems and depression, that will take be administered over the course of six months. Youth~     with comorbid conduct problems and depression will be assigned to the experimental condition~     or treatment as usual in a community care setting. The treatment manual will be revised as~     needed. Youth will be assessed before and after treatment to examine program potential. The~     goal of this research is to develop a more comprehensive outpatient treatment for youth with~     both conduct problems and depression.~   "
136541|NCT01267760|"~     The purpose of this study is to investigate whether recycled dialysis fluid can supply~     enough clearance for hemodiaysis patients.~   "
136542|NCT01267747|"~     Primary objective of the PAPPHY Study is to establish the prevalence of primary~     aldosteronism (PA) in consecutive hypertensive patients hospitalized for lone (non~     valvular), paroxysmal, persistent or permanent atrial flutter or fibrillation (AFF).~      Secondary objectives are to identify:~        1. the clinical, echocardiographic and biochemical predictors of AFF in the hypertensive~          patients with/without PA;~        2. if AFF, by increasing ANP and/o BNP thereby conceivably blunting aldosterone secretion,~          can lower the ARR and impede PA detection.~        3. the usefulness of the aldosterone-to-renin ratio (ARR) based on plasma renin activity~          (PRA) and the direct measurement of renin (DRA) for diagnosing PA in patients with AFF.~        4. the rate of recurrence or new onset AFF during follow-up in a cohort of hypertensive~          patients with/without PA as a function of specific treatment for the latter.~      Design: cohort multicenter prospective study. Sample size: 1000 consecutive patients.~      Procedure At baseline cardiac function, arterial stiffness, and plasma renin activity (PRA),~     direct renin assay (DRA), plasma aldosterone (PAC) will be measured. Pharmacologic or direct~     current cardioversion (DCC) will be performed if indicated according to 2010 ESC guidelines.~      PRA and PAC will be measured again 2 weeks after cardioversion to answer secondary aim b.~      If ARR is > 26 and PAC > 15 ng/dL, adrenal vein sampling (AVS) will be performed in patients~     willing to undergo adrenalectomy to identify a lateralized PAC excess.~      Follow-up will be aimed at assessing damage organ, occurrence of cardiovascular events and~     recurrence of AFF in patients with or without PA.~      Demonstration of a higher prevalence of PA in the patients with AFF as compared to the~     general population of the hypertensive subjects will provide evidence for 1) a role of~     aldosterone excess in causing AFF and cardiac electric remodeling; 2) the usefulness of case~     detection of PA in hypertensive patients with AFF; 3) the predictors of AFF; 4) the outcome~     of specific treatment for PA on risk of incident and recurrent AFF.~   "
136543|NCT01267734|"~     Objectives~        1. To compare the safety and long-term effectiveness of coronary stenting with the new~          platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared~          with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in~          patients with coronary heart disease (CHD)~        2. To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT,~          Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with~          double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and~          Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI)~          with drug-eluting stents (DES)~      Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial~     to test the following in CHD patients~        1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in~          reducing target lesion failure (TLF)~        2. Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients~          will be randomized in a 2-by-2 factorial manner according to the type of drug eluting~          stent (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT).~          Randomization will also be stratified per presence of DM.~      Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea~      Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the~     procedure. Angiographical follow-up will be recommended to all participants at 13 months~     after the procedure. Investigator or designee may conduct follow-up as telephone contacts or~     office visits.~      Primary endpoint~        1. Target lesion failure (TLF), defined as a composite of cardiac death, target~          vessel-related myocardial infarction (MI) and ischemia-driven target lesion~          revascularization (TLR) up to 12 months for the stent arm~        2. Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and~          major bleeding by PLATO criteria at 1 month for the anti-platelet arm~   "
138435|NCT01242943|"~     The aim of this Study Protocol is to provide a basis for the clinical development of~     131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase~     I study.~   "
136548|NCT01267669|"~     Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of~     acute variceal bleeding and five-day haemostasis has been shown to significantly improve~     when vasoactive drug is added. However, there is limited data whether addition of~     somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.~      Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal~     bleeding.~      Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from~     esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized~     to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was~     treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour~     after start of therapy or death.~   "
136549|NCT01267643|"~     Aplastic Anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated~     T-lymphocytes that leads to pancytopenia. The disease related morbidity and mortality if~     left untreated can approach 90%. For over 30 years, anti-thymocyte globulin (ATG) in~     combination with cyclosporine (CsA) remains the standard therapy. However, the treatment~     response with ATG is at best between 50-60% with a sizeable number of partial responses.~     Treatment with ATG is also associated with significant toxicity and high relapse rate that~     can be as high as 45%. Since the prognosis in refractory and relapsed AA remains poor, there~     is a need for less toxic novel immunosuppressive agents that can improve response rates and~     remission duration in refractory and relapsed AA.~      Alefacept is a human recombinant dimeric fusion protein composed of the terminal portion of~     leukocyte functioning antigen-3 (LFA3/CD58) and the Fc portion of human IgG1. It prevents~     co-stimulatory signals between antigen presenting cells and memory T cells by competitive~     inhibition of CD2 in T cells, induces selective apoptosis of CD4+ and CD8+ memory effector T~     cells by interaction between the Fc portion of IgG1 and the FcyIII in NK cells, and possibly~     direct ligation of CD2 molecules on T cells that subsequently result in the alteration in T~     cell agonist signaling. It has been used successfully in the treatment of other T cell~     mediated disorders particularly psoriasis and steroid refractory graft versus host disease~     (GVHD) with minimal side effects. In a case of liver transplant associated AA (similar to~     transfusion associated AA) which is fatal in most patients, Alefacept induced remission~     after patient did not respond to ATG and other immunosuppressants. The investigators~     hypothesize that the LFA3-CD2 co-stimulatory pathway play an important role in the immune~     pathogenesis of AA and treatment with Alefacept can help treat refractory/relapsed cases of~     AA.~   "
136550|NCT01267630|"~     The purpose of this study is to determine the validity and reliability of the Thai version~     of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the~     prevalence of delirium in elderly.~   "
136551|NCT01267617|"~     To determine if proprietary software that uses pulse-wave analysis to interpret the output~     of a conventional pulse-oximeter, can predict the onset of circulatory stress, before~     changes in blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.~   "
136552|NCT01267604|"~     An efficient protocol of ovarian stimulation is a key part of assisted reproductive~     technology. In order to obtain the highest oocyte retrieval with no adverse effects,~     numerous studies have evaluated the efficiency of the clinical approaches currently~     available.~      Recent studies have shown that two natural compounds, such as inositol and melatonin, play~     an important role in oocyte maturation and quality. Therefore, the present study aims at~     investigating whether inositol and melatonin are able to improve the number of oocytes~     obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).~      To this purpose, a randomized double-blind trial will be established where 150 healthy women~     in reproductive age undergoing to assistant reproductive technology (ART) because of male~     infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone,~     group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.~      As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical~     pregnancy rate and live birth rate will be evaluated in group A vs. group B.~   "
136553|NCT01267591|"~     Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed~     method for noninvasive endothelial function assessment.~      Objective: The goal of this study is to determine whether a significant difference in RH-PAT~     score is present between adolescents with type 1 diabetes (T1D) in comparison with controls.~     We will also compare RH-PAT scores in obese adolescents versus controls.~   "
136554|NCT01267578|"~     The purpose of this study is to evaluate overall survival and immunological monitoring for~     peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally~     advanced, recurrent, or metastatic esophageal squamous cell carcinoma~   "
136555|NCT01267565|"~     Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff~     contribute to the constitution of VAP. The pepsin has been recently proved effective as a~     surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin~     dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The~     aim of our study is to asses whether the value of amylase, which is mostly secreted by~     salivary glands, may turn out to be a new and simpler surrogate for microaspirations in~     ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose~     endotracheal tube includes a subglottic secretion device and producing sufficient~     endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral,~     subglottic, tracheal) will be performed during one ventilation day for amylase dosage~     purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed.~     In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating~     a tracheal aspiration during the procedure will be included as a control group. The primary~     assessment criteria will be the oral/tracheal amylase ratio.~   "
136556|NCT01267552|"~     To study the safety of not draining the axilla, after breast conserving surgery and full~     axillary lymphadenectomy.~   "
136557|NCT01267539|"~     A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City~     Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice~     daily for four weeks.~   "
136558|NCT01267526|"~     This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment from hospital and to assess the level of adherence of subject~     receiving SAIZEN® via Easypod™ .~   "
136572|NCT01267344|"~     The primary objective is to investigate the objective response rate in patients receiving~     GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or~     metastatic unresectable BTC biliary tract cancer compared to patients receiving the same~     chemotherapy without cetuximab. The secondary objectives include the exploration of the~     effect of the multimodality strategy on progression-free and overall survival, biomarker~     prediction, and toxicity.~   "
136559|NCT01267513|"~     Ambulatory monitoring of physiological variables is important in following the health status~     of individuals in non-hospital controlled situations. The investigators are developing a~     non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood~     flow and coagulability. Oxygen saturation can also be detected with minor modification of~     the apparatus. The investigators plan to validate the investigators sensor by applying it to~     patients in the intensive care unit, or to patients undergoing cardiac stress tests. The~     results of the investigators sensor will not be utilized for any therapeutic decisions, but~     will be collected for later comparison with conventional monitoring of pulse and oxygenation~     with standard monitors. The monitor is worn like a wrist watch, and will collect data into a~     small data storage disc for later analysis.~   "
136560|NCT01267500|"~     Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help~     in increasing control of strabismus~   "
136561|NCT01267487|"~     There are currently several schemes described for anticoagulation with heparin and its~     reversal with protamine during cardiac surgery with CPB. The oldest, and most used in our~     routine environment, is the scheme of fixed doses, in which a bolus dose of heparin at the~     start of CPB is established in IU/kg of body weight and the dose of protamine at the end of~     CPB is calculated based on the initial dose of heparin administered.~      These schemes do not take into account the variability inter-patients and can result in~     overdose or sub-doses of one or both drugs.~      The titration schedule of doses of heparin and protamine through the principle of~     dose-response curve of Bull promotes individualization of dosage according to the response~     of each patient. This scheme has been associated with an effective reversal of the effect of~     heparin after CPB and with reduction of post-operatory bleeding and transfusion.~      The restoration of a state of anticoagulation by heparin after its reversal by protamine is~     called rebound effect. It is a phenomenon explained by the recirculation of heparin stored~     in the reticulum-endothelial system and connective tissue, or by free residual concentration~     of heparin after clearance of protamine. This effect may be present for more than 6 hours of~     post-operatory and may contribute to increase post-operatory bleeding.~   "
136562|NCT01267474|"~     The main objective was to evaluate the effect of a nutritional education program for school~     lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.~   "
136563|NCT01267461|"~     Recently the general medical literature has become aware that the use of certain long-acting~     insulin analogues could potentially increase cancer risk.During the last few years the~     investigators group generated information of both scientific and clinical relevance on the~     proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is~     to evaluate the hypothesis that the proliferative and signalling activities elicited by~     insulin analogues may have a impact on tumor behavior. In this study the investigators will~     asses the biological actions of insulin analogs in primary tumor cells of endometrial and~     colon cancer.~   "
136564|NCT01267448|"~     Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels~     in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels~     300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or~     occurrence of severe hypoglycemia compared to glipizide XL.~      The study may provide preliminary evidence to support the role of S+M as a bridging,~     stabilizing and safe therapy in patients with severe hyperglycemia~   "
136565|NCT01267435|"~     The purpose of this study is to evaluate the accuracy of tunnel positions in anterior~     cruciate ligament reconstruction~   "
136566|NCT01267422|"~     This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber~     hereditary optic neuropathy with 11778 LHON mutation.~   "
136567|NCT01267409|"~     Depressive symptoms of Parkinson's disease (PD) patients are major predictors of their~     prognosis and quality of life. Using subthalamic nucleus (STN) deep brain stimulation (DBS)~     as an antidepressant could be a promising new direction. Existing methods of adjustment of~     DBS parameters aim at amelioration of the motor signs and therefore with inactivation of the~     STN motor territory only. Although the DBS parameter setting is believed to influence the~     mental state, there is no data that correlates stimulation parameters with mental state. The~     investigators hypothesize that the emotional territories of the STN have distinct~     electrophysiological properties and that specific stimulation of these emotional territories~     can influence the mental state and thus treatment with emotionally-adjusted DBS can improve~     the psychiatric symptoms of PD. In this project, the investigators intend to map the~     emotional territories of the STN using neuronal (single units) responses to emotional voices~     and to identify the emotional spectral signature of the STN single unit activity using~     spectral analysis and neuronal responses to emotional voices. The investigators also intend~     to investigate the emotional processing of PD patients by manipulating the stimulation of~     the subthalamic area. The proposed study will combine neural recording, stimulation and~     psychological tests to shed new light on emotional processing in the basal ganglia, as well~     as to provide better treatment for PD emotional disorders,~   "
136568|NCT01267396|"~     The objective of this study was to compare and evaluate the single-dose oral bioavailability~     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories~     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fasting~     conditions in healthy adult human subjects.~   "
136569|NCT01267383|"~     The objective of this study was to compare and evaluate the single-dose oral bioavailability~     of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories~     Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fed conditions~     in healthy adult human subjects.~   "
136570|NCT01267370|"~     The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of~     chronic constipation.~   "
136571|NCT01267357|"~     P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma.~     Evidence from previous trials indicates that it may be used as a diagnostic biomarker~     distinguishing this disease from endometrioid endometrial cancer. Additional evidence points~     to its prognostic value.~      The current study will evaluate p16 both as a diagnostic tool for serous papillary~     endometrial cancer and as a prognostic biomarker.~      following anonymization, histology blocks will be microtomed and stained for P16 and P53~     proteins.~      Blocks from endometrioid endometrial cancer will be used as a control group.~   "
136576|NCT01267292|"~     Chronic cocaine use may produce disruption of neurotransmitter functions (including~     dopamine). This may in turn contribute to measurable dysfunction in important cognitive and~     behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating~     cocaine dependence and improving behavioral function -- supporting the notion that these~     processes are related. An important step is to understand the subjective, physiological, and~     behavioral effects of potential medications for cocaine dependence.~      DA-modulating drugs may be targets for pharmacotherapy for substance dependence, and~     particularly for stimulant drugs like cocaine, which disrupt normal DA function. Buspirone~     is currently the only available dopamine subtype 3 (DA3) approved for human administration,~     and is thus a viable investigational compound.~      This project proposes to evaluate the DA-modulating effects of buspirone on behavioral~     deficiencies related to DA depletion. Accordingly, the project aims to characterize the~     effects of buspirone in individuals with cocaine dependence. Employing a daily dosing~     designs within an acute stimulant challenge (methylphenidate), the experiment will~     characterize the subjective effects, cardiovascular effects, and behavioral effects~     (attentional bias to drug cues and risky decision making). The primary hypotheses are that~     buspirone will attenuate the increases in subjective drug effects (stimulated, like~     drug) and behavioral effects (increases in attentional bias and risky decision making) that~     are produced by acute methylphenidate administration.~   "
136577|NCT01267279|"~     In a randomized, double-blind trial, BMD of the operated proximal femur after total hip~     replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two~     years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n~     = 24) at two weeks and one year after surgery.~   "
136578|NCT01267266|"~     This randomized phase II clinical trial is studying how well saracatinib works in treating~     patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
136579|NCT01267253|"~     This phase II trial studies how well brivanib alaninate works in treating patients with~     cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~   "
136580|NCT01267240|"~     This partially randomized phase II trial studies giving capecitabine and vorinostat in~     treating patients with head and neck cancer that has come back after previous treatment or~     that has spread to other areas in the body. Drugs used in chemotherapy, such as~     capecitabine, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether giving~     capecitabine together with vorinostat is more effective than capecitabine alone in treating~     patients with cancer of the head and neck cancer.~   "
136581|NCT01267227|"~     Pterostilbene is one of several stilbenes found in certain berries, particularly~     blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and~     oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help~     control cholesterol and blood pressure, as well as improve markers for oxidative stress in~     patients with dyslipidemia meeting inclusion criteria. The investigators also want to look~     at the safety of pterostilbene in these patients.~   "
136582|NCT01267214|"~     The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal~     tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who~     were treated with osteotomy will not be treated with any SYSADOA after operation, even~     though their cartilage's not completely loss, so osteotomy plus HA injection should provide~     more benefit to patients than osteotomy alone.~   "
136583|NCT01267201|"~     A new formulation of methylprednisolone is being developed. A study is needed to determine~     the drug availability using the new formulation, a powder for reconstitution into a~     suspension, versus the current commercially available tablet formulation in healthy~     volunteers.~   "
136584|NCT01267188|"~     The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and~     50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects~     with schizophrenia or schizoaffective disorder.~   "
136585|NCT01267175|"~     The user evaluation is to assess user acceptance and the quality of training materials for~     the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of~     the new system.~   "
136586|NCT01267162|"~     This is a Phase IV, open-label, single-arm, 96 week community-based observational study~     evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected~     Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123~     study. The primary objective of this study is to evaluate the long-term antiviral efficacy~     of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to~     evaluate the safety and tolerability of TDF including the biochemical and virological~     responses to TDF, the incidence of drug resistance mutations in these patients The duration~     of treatment in this study is total of three Years (144 weeks) on TDF.~   "
136587|NCT01267149|"~     Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines~     in the treated areas as compared to baseline.~      Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas~     as compared to baseline.~   "
136609|NCT01266863|"~     To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram~     analysis is required. E test strips have successfully provided an antibiogram 24 h after~     having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective~     cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with~     the aim of validating a new method increasing the rapidity of antibiogram analysis compared~     to standard methods of culture. This antibiogram will be provided by E test strips directly~     applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th~     hour after its completion. The occurrence of major errors (S with E test method, I or R with~     standard method) and minor errors (I or R with E test method and S with standard method)will~     be observed and a comparison of H6, H10 and H24 results performed.~   "
136664|NCT01266148|"~     A controlled, randomized, open-label, multicenter study evaluating if early initiation of~     everolimus and early elimination of cyclosporine in de novo heart transplant recipients can~     improve long-term renal function and slow down the progression of chronic allograft~     vasculopathy~   "
136588|NCT01267136|"~     Tonsillectomy is the most common pediatric surgical procedure performed in the US. The~     postoperative period can be particularly painful. Codeine (usually in mixed formulation with~     acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data~     questions its ability to provide optimal pain relief, while avoiding side effects,~     especially in the postoperative setting. Tramadol may be a better option for children in the~     postoperative setting due to its well-documented analgesic properties, low potential for~     side effects, and excellent safety profile. Seventy-two children scheduled to undergo~     tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate~     in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects~     of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers~     will be asked to record daily information about their child's postoperative pain and other~     core outcomes and domains as recommended in the recent consensus statement put forth by the~     Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials~     (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the~     efficacy and side effects associated with tramadol as compared with codeine/acetaminophen~     (the current practice standard) in a pediatric population.~      Hypotheses~      H1: Children who receive scheduled tramadol following tonsillectomy will report better pain~     control than children who receive scheduled codeine/acetaminophen.~      H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side~     effects than children who receive scheduled codeine/acetaminophen.~   "
136589|NCT01267123|"~     Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and~     remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at~     the tip, through the colon. The insertion process can be difficult in some patients,~     resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of~     the bed so that the stretcher forms a 15 degrees angle with the floor (Trendelenburg~     position) may make the colonoscopy easier and more comfortable to the patient.~   "
136590|NCT01267110|"~     Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being~     preventable, easily detectable, and curable.2-11 Breast screening continues to be~     underutilized by the general population and especially by traditionally underserved minority~     populations. Two of the least screened minority groups are American Indians/Alaska Natives~     (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year~     cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates~     for major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality~     among Latina women.13 While breast cancer screening rates have increased nationally, there~     has been an increase in the gap in breast cancer screening utilization between individuals~     from minority versus majority racial/ethnic groups.~   "
136591|NCT01267097|"~     The Canadian pediatric obesity epidemic has led to great interest in evaluating weight~     management care for obese children and families. Investigation is warranted since obesity is~     linked to risk factors for chronic diseases including type 2 diabetes mellitus (T2DM) and~     cardiovascular disease (CVD). Over the past 25 years, many interventions have studied the~     role of healthy lifestyle behaviours to help obese children achieve and maintain a healthy~     weight. A contemporary view of pediatric weight management interventions includes parents as~     a fundamental recipient of treatment. These interventions recognize the influence parents~     have on the lifestyle behaviours of their children. While such parent-based interventions~     have helped establish the role of education and behavioural theory in facilitating lifestyle~     changes, we believe an equally important intervention element is a focus on the role of~     cognitions in helping to interpret behaviour change and change maintenance. Our study~     incorporates cognitive behaviour theory (CBT) into an intervention for parents of obese~     children and compares it to a more traditional modality based on psycho-education (PEP).~      Hypothesis: Obese 8 - 12 year old children (n=45) whose parents complete a 16-session,~     group-based, CBT intervention will achieve greater reductions in adiposity as well as~     improvements in physiological risk factors for T2D, lifestyle behaviours, and psychosocial~     outcomes at post-intervention as well as 6- and 12-months follow-up versus children (n=45)~     whose parents complete a 16-session, group-based, psycho-education intervention .~      Primary Objective: To compare the impact of two weight management interventions (CBT versus~     PEP) for parents of obese children on child BMI z-score.~      Secondary Objective: To measure a comprehensive set of physiological, behavioural and~     psychosocial outcomes in obese children and parents pre- and post-intervention.~      We expect obese children whose parents complete the CBT intervention will experience greater~     reductions in BMI z-score vs. children whose parents complete the PEP intervention. We~     anticipate that improvements in parenting style, family stress, and lifestyle behaviours~     will be important to improve adiposity, lifestyle behaviours, and risk factors for T2DM and~     CVD in obese children.~   "
136592|NCT01267084|"~     The purpose of this study is to evaluate the potential effects of ketoconazole on blood~     levels of trabectedin after administration to patients with advanced malignancies.~   "
136593|NCT01267071|"~     The purpose of this study is to determine the absolute oral bioavailability and intravenous~     pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well~     tolerated following single oral administration and it is considered to be within therapeutic~     dose range. The need to characterize the intravenous disposition of GSK962040 is in~     anticipation of drug use in special populations such as critically.~   "
136594|NCT01267058|"~     The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline~     Biologicals' (formerly known as SmithKline Beecham Biologicals) combined~     diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18~     onwards, in Australia.~   "
136595|NCT01267045|"~     This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a~     standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms~     associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five~     veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as~     usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at~     baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at~     equivalent time points for veterans randomized to TAU only. Following completion of all~     study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.~   "
136596|NCT01267032|"~     This project is designed to determine whether an efficacious behavioral intervention for~     insomnia can improve the quit rates achieved by an efficacious smoking cessation program~     aimed at PTSD patients (Integrated Care). A second aim is to deepen our understanding of~     the mechanisms relating sleep and smoking in PTSD.~   "
136635|NCT01266525|"~     Primary Objective:~      - To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in~     comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's~     disease (AD) while on stable donepezil therapy~      Secondary Objectives:~        -  To explore the effect of SAR110894 on functional impairment, global clinical status and~          behavioral disturbances;~        -  To assess the safety/tolerability of SAR110894;~        -  To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;~        -  To explore caregiver time consumption and distress changes.~   "
136597|NCT01267019|"~     Veterans with schizophrenia and schizoaffective disorder experience high levels of~     disability and poor community outcome, and these poor functional outcomes constitute a major~     public health concern. The treatment of schizophrenia spectrum disorders has shifted~     fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects~     of functioning. Needed improvements in community outcome for patients with these disorders~     will not occur simply through better control of clinical symptoms. Instead, it is necessary~     to find new treatments that address the key determinants of poor functional outcome,~     including social cognition. Both basic (non-social) cognition and social cognition are~     considered key determinants of functional outcome for schizophrenia and schizoaffective~     disorder. Basic cognition includes the domains of: learning and memory, vigilance /~     attention, speed of processing, reasoning and problem solving, and working memory. Social~     cognition generally refers to mental operations that underlie social interactions, including~     perceiving, interpreting, managing, and generating responses to socially relevant stimuli,~     including the intentions and behaviors of others. As part of the investigators' previous~     Merit grant, they have developed a training program for social cognition and are in the~     process of validating it. Initial results suggest that the program improves performance on~     measures of social cognition and functional capacity.~      In this study, the investigators will evaluate whether adding an in vivo component (training~     activities that occur in the community) to the current social cognition intervention~     facilitates generalization of training effects to community outcome and subjective~     satisfaction. Outcome measures of social cognition and functional capacity will be examined~     during the 12 week training program, and durability of benefits will be assessed at a~     3-month follow up. Generalization to community functioning and subjective satisfaction will~     be assessed at the end of training and at the 3-month follow up. The investigators will~     enroll 105 patients across the 5 years of the study with random assignment to training group~     (social cognition intervention with in vivo exercises, social cognition intervention without~     in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks~     (mid-point), completion of training (12 weeks), and the 3-month follow up.~   "
136598|NCT01267006|"~     This study will invite two groups of volunteers to participate.~      The data from one group of volunteers will be used to find out how much study drug, known as~     GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected~     to find out if the level of cetain blood cells, known as neutrophils, change significantly~     after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64~     years of age.~      The data from the other group of volunteers will be used to find out if taking the study~     drug, GSK1325756, twice in one day with or without food, makes a difference to the level of~     study drug in the blood. This group of volunteers will also provide data to find out if any~     study drug metabolites are present in the bile, a fluid secreted by the liver. This group of~     volunteers will be aged 65 to 80 years of age.~   "
136599|NCT01266993|"~     The purpose of the study is to evaluate the persistence of the immune response of GSK134612~     vaccine up to 68 months after vaccination in the primary vaccination study (NCT number =~     NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and~     immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the~     primary vaccination study with either GSK134612 vaccine or Menjugate®.~      This protocol posting deals with objectives & outcome measures of the persistence and~     booster epochs. The objectives & outcome measures of the primary epoch are presented in a~     separate protocol posting (NCT number = NCT00674583)~   "
136600|NCT01266980|"~     This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once~     daily for 7 days to patients with severe renal imparement. The results of this study will~     aid in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe~     renal impairment and in estimating any such adjustments.~   "
136601|NCT01266967|"~     This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of~     an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or~     V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have~     received any local brain therapy, and subjects in Cohort B will have received prior local~     therapy for brain metastases. Subjects will continue on treatment until disease progression,~     death, or unacceptable adverse event.~   "
136602|NCT01266954|"~     The purpose of this study is to explore the potential dose response relationship between the~     pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose~     metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed~     with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor~     biopsies will be done prior to initiation of dosing and sequentially at select time points~     during the first five weeks of dosing. The maximal dose of a given schedule evaluated in~     this study will not exceed the maximal tolerated dose established in the first-time-in-human~     trial PCS112689 for the same schedule.~   "
136603|NCT01266941|"~     In relation to their severity, hepatic diseases can significantly modify drug absorption and~     disposition and consequently can interfere with drug efficacy and/or produce toxicity. The~     purpose of this study will be to aid in deciding whether a dose adjustment is required in~     subjects with hepatic impairment and in estimating any such adjustments.~   "
136604|NCT01266928|"~     Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all~     pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide~     with increased rates of neonatal and maternal morbidity and mortality. Despite its~     frequency, very little is known about its pathophysiologic mechanisms. Mechanical strength~     is provided to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV~     are the main collagen types in these membranes. Studies have shown that total collagen~     content is reduced in the amnion of women with preterm PROM.~      Vitamin C is involved in the metabolism of collagen and has been proposed to play an~     important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin~     E may play a synergic role with vitamin C, increasing the antioxidant capacity against~     reactive oxygen. Woods et al hypothesized that an increase in dietary consumption or~     supplementation of vitamin C and E during pregnancy might reduce the risk of that portion of~     preterm PROM that may be mediated by oxidative injury to fetal membranes. Plessinger et al~     report that pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous~     acid-induced membrane damage.~      Borna et al. reported a randomized, double-blind controlled study of vitamin C and E~     supplementation, in which women with preterm rupture of membranes and singleton gestations~     at 26 to 34 weeks were randomized to vitamin C and E supplementation or placebo.~     Supplementation with vitamin C and E were associated with longer latency before delivery.~     However, the sample size in this study was very small.~      The aim of this study was to evaluate the effect of supplementation with vitamins C and E~     after preterm premature rupture of membranes. We hypothesised that supplementation vitamins~     C and E may be effective in decreasing oxidative stress and increasing the latency period.~   "
136605|NCT01266915|"~     Approximately 1.4 million individuals in the United States have systemic lupus~     erythematosus, and about 85% of these individuals develop skin lesions at some point of~     their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic~     lupus erythematosus, and can appear in people with or without systemic lupus. It is a~     mentally, physically, and emotionally debilitating disease that affects both the quality of~     life and social well-being of those affected.~      The cause of cutaneous lupus is not completely understood, but likely includes multiple~     factors from our genes and the environment. Multiple genetic studies with small numbers of~     cutaneous lupus patients have been performed to determine which genes are associated with~     cutaneous lupus. This study aims to accumulate even larger numbers of patients to~     confidently identify genes and the proteins they encode that could contribute greatly to the~     formation of cutaneous lupus. The discovery of these genes and proteins would help not only~     uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease~     and predict its course, and stimulate new drug development.~   "
136610|NCT01266850|"~     Rotavirus, sometimes called the stomach flu, is the most common cause of severe diarrhea~     in children. Vaccines can prevent many types of infections and work by causing the body to~     make proteins called antibodies that fight infection. For some vaccines, more than one~     vaccination is needed so that the body will make enough antibodies to fight infection. The~     vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for~     infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on~     Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be~     effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will~     participate for about 10-12 months. Study procedures include reaction assessment and blood~     sample.~   "
136611|NCT01266837|"~     A single arm, open-label, multi-center phase IV clinical trial for patients with metastatic~     renal cell carcinoma, who have progressed on or after the first VEGF-targeted therapy.~   "
136612|NCT01266824|"~     In this study, we will be evaluating whether premedication with an anesthetic eye drops~     leads to a decreased sensation of pain when given dilating eye drops prior to eye~     examinations to evaluate for retinopathy of prematurity in neonatal intensive care unit~     (NICU) infants.~   "
136613|NCT01266811|"~     The purpose of this study is to determine if there is an improvement in progression-free~     survival (length of time during and after treatment in which a patient is living with a~     disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in~     subjects with relapsed or refractory multiple myeloma.~   "
136614|NCT01266798|"~     Access to the best available evidence, and the ability to obtain and understand such~     information is seen as necessary to protect the public's interests and critical to~     empowerment, but is also a precondition for participation in the decision making.~      A web portal serving as a generic (non disease- specific) tailored tool was developed in the~     conceptual framework of shared decision making and evidence based practice to improve the~     lay- public's critical and social literacy skills and activation. A randomized controlled~     parallel trial using a simple randomization procedure will be conducted, including 200~     parents of children <4 with internet access. Parents will be allocated to receive either the~     portal or no intervention. Primary and secondary outcomes include: the ability to find~     research based information, critical appraisal skills, perceived behavioural control,~     attitudes and perceived pressure associated with searching for information, and~     participation.~   "
136615|NCT01266785|"~     Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract.~     Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It~     is a lifelong disease with frequent flares during the course of the disease. Crohn's disease~     is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication~     for treating severe Crohn's disease. This medicine is effective by blocking special~     substance (tumor necrosis factor) released from certain white blood cells in the body.~     Infliximab is given via a vessel at week 0, 2, 6 initially, then every 2 monthly for~     maintenance. However, some of patients with Crohn's disease do not respond infliximab.~     Currently there is no test to reveal which patients will respond to treatment. This study~     aims to analyze and compare particular subgroup of white cells and its products during and~     after infliximab treatment which may determine the responsiveness to infliximab treatment.~   "
136616|NCT01266772|"~     This is 9 month, placebo-controlled, double blind, randomised trial using the oral~     leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate~     asthma age 6-14 year old, sensitive to house dust mite. There are two study groups:~     montelukast group 80 patients and placebo group 80 patients. All patients will receive~     budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as~     needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's~     visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of~     asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control~     (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children~     with not fully control asthma had administered 100 mcg higher dose of budesonide.~   "
136617|NCT01266759|"~     To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral~     Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile~     age~   "
136618|NCT01266746|"~     The aim of this study is to determine the condition to detect the status of a macular hole~     by spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular~     area is scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent~     vitreous surgery for macular hole to detect macular jole closure on postoperative days 1, 3,~     7, and 30.~   "
136619|NCT01266733|"~     The purpose of this study is to assess improvement in health related quality of life of~     fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual~     treatment.~   "
136620|NCT01266720|"~     The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with~     gemcitabine in treating HLA-A*0201 restricted patient with non-resectable pancreatic cancer.~   "
136621|NCT01266707|"~     The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in~     treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.~   "
136622|NCT01266694|"~     Background: The incidence of asymptomatic pericardial effusion is high after cardiac~     surgery.~      Objective: To assess whether colchicine is effective in reducing post operative pericardial~     effusion volume.~      Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention :~     colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac~     rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate~     to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by~     echocardiography) more than 7 days after cardiac surgery.~      Measurements: The main end point will be change in effusion grade after 14 days of~     treatment. Secondary endpoints include frequency of late cardiac tamponade.~   "
136636|NCT01266512|"~     Primary Objective:~        -  Response rate (by contrast CT scan)~      Secondary Objectives:~        -  Progression-free survival (PFS)~        -  Overall survival (OS)~   "
136665|NCT01266135|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy~     of QAX576 in patients with idiopathic pulmonary fibrosis.~   "
136623|NCT01266681|"~     Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and~     accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms~     of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue,~     with quality of life measures reduced for patients with persistent AF, increased stroke risk~     and increased all cause mortality rates. DC Cardioversion is used to restore normal sinus~     rhythm in patients with persistent AF. It has a high success rate but reoccurence of AF is~     common. The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining~     in sinus rhythm at one year, with amiodarone currently the most superior. Unfortunately it~     can have serious side affects. Dronedarone is a related drug designed specifically to~     minimise the most serious side affects and is no approved and used prominently in the~     management of non permanent AF. However it has not yet been studied in a post DC~     Cardioversion population.~      Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised~     to receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu~     rhythm post cardioverion in one NHS hospital. Patients will be followed up for a year post~     cardioversion to see if they stay in sinus rhythm.~      Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or~     dronedarone~   "
136624|NCT01266668|"~     The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL~     using a matched pair analysis following strict matching criteria in patients with primary~     breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin,~     vincristine, and prednisone (R-CHOP) regimen.~   "
136625|NCT01266655|"~     There is first evidence from preclinical and clinical studies for the efficacy of the~     selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim~     of this trial is to evaluate the efficacy and safety of individually titrated high-dose~     baclofen for relapse prevention in alcohol-dependent patients.~   "
136626|NCT01266642|"~     The goal of this clinical research study is to compare how 4 weeks of radiation treatment~     affects the breast to how 6 weeks of radiation treatment affects the breast. Researchers~     also want to know about other side effects of radiation.~   "
136627|NCT01266629|"~     Capsule endoscopy (CE) is considered as a gold standard examination for small bowel Crohn's~     disease. However, it is time-consuming, expensive and results are largely influenced by the~     operator's skills. We, therefore, want to assess the predictive value of fecal calprotectin~     and lactoferrin in patients undergoing CE.~   "
136628|NCT01266616|"~     Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's~     natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This~     study will test whether giving an HIV-1 vaccine together with or without interleukin 12~     (IL-12) is safe and effective. This study will also test a new way of giving the vaccine~     called electroporation (EP).~   "
136629|NCT01266603|"~     The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2),~     when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer~     Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients~     whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be~     studied. Researchers will also use samples of the original tumor or metastatic tissue (for~     example, lymph nodes or liver or lung) that are collected during screening to study if~     response to the study drug is related to the genes in the tissue.~   "
136630|NCT01266590|"~     The purpose of this study is to determine how much digoxin gets into the blood stream and~     how long it takes the body to get rid of it when given with LY2216684. Information about any~     side effects that may occur will also be collected.~   "
136631|NCT01266577|"~     Background:~      - Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of~     the human body and evaluate activity in the brain. A particular MRI method called magnetic~     resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help~     researchers who are studying new treatments for psychiatric illnesses. Researchers are~     interested in improving current MRI and MRS techniques, as well as developing new MRI and~     MRS techniques to view and measure brain chemicals and brain activity.~      Objectives:~      - To implement, develop, and optimize brain chemistry imaging techniques using magnetic~     resonance imaging and magnetic resonance spectroscopy.~      Eligibility:~      - Healthy individuals between 18 and 65 years of age.~      Design:~        -  This study will involve a screening visit and a scanning visit at the National~          Institutes of Health Clinical Center.~        -  Participants will be screened with a full medical and physical examination, blood and~          urine tests, and neurological testing.~        -  During the second visit, participants will have an MRI scan of the brain. (Participants~          who have received an MRI within the past year will not need to have a second one; the~          images of the previous scan will be used for this study.) All participants will then~          have an MRS scan using the same scanning equipment.~   "
136632|NCT01266564|"~     This observational study will assess the progression-free survival, overall response and~     safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in~     patients with metastatic colorectal cancer. Data will be collected from patients for~     approximately 2 years.~   "
136633|NCT01266551|"~     What's known? Prone position is no longer a treatment option for GERD because of the~     association with SIDS. Originally, positioning in an infant seat was recommended for infants~     with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared~     to prone positioning.~      What's new? Positioning in an infant seat caused no increase in GER, compared with the~     supine 15 degrees anti-Trendelenburg position. Except for the number of long reflux~     episodes, which was significantly higher in the car safety seat. Larger trials are needed~     for decisive conclusions.~   "
136634|NCT01266538|"~     This will be a comprehensive epidemiological, clinical, endoscopic and histological database~     for inflammatory bowel diseases patients in our medical center that will further provide~     clinical and basic investigations.~   "
136637|NCT01266499|"~     Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen.~     It is currently the fourth most common cause of pneumonia and fifth most common cause of~     bacteremia in intensive care patients (1-3).~      The aim of the present randomized controlled trial is to assess the efficacy of~     non-absorbable oral antibiotics in the eradication of the KPC carrier state.~   "
136638|NCT01266486|"~     Metformin, a drug that has been used since the 1950's in the treatment of diabetes, has~     recently generated great interest in its anticancer effects based on in vitro, in vivo and~     clinical studies. This study assesses the pharmacodynamic effects of metformin on breast~     cancer metabolism.~      The trial design is based on a 2 centre study 'Early Antiangiogenic Response to Bevacizumab~     in Primary Breast Cancer' that is about to successfully complete recruitment in Oxford and~     Mount Vernon hospitals. The study takes advantage of the 2 week window between the first~     clinic visit and commencement of neoadjuvant chemotherapy. Metformin will be given to~     patients for at least 2 weeks prior to neoadjuvant chemotherapy with a set of 3 breast core~     biopsies, a PET-CT scan and blood tests carried out before and after this 2 week period of~     treatment. Patients will also receive a drink of heavy (deuterated) water, a safe and stable~     isotope commonly used in clinical lipid metabolism studies, the evening prior to both sets~     of core biopsies. Having completed the first 2 weeks of metformin patients will have the~     option of continuing metformin until completion of chemotherapy, at the discretion of the~     trial physician.~      The core biopsies will then be used to assess for changes in:~        -  immunohistochemical staining;~        -  gene profiles;~        -  uptake of heavy water into tumour fatty acids using mass spectrometry techniques.~      The aim is to identify potential biomarkers of response to metformin (and other future~     cancer metabolism drugs).~   "
136639|NCT01266473|"~     The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway~     Clearance, and to investigate user experience, i.e.utility value and preference.~   "
136640|NCT01266460|"~     This phase II trial studies the side effects and how well vaccine therapy works in treating~     patients with cervical cancer that does not go to remission despite treatment (persistent)~     or has come back (recurrent). Vaccines therapy may help the body build an effective immune~     response to kill tumor cells.~   "
136641|NCT01266447|"~     This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride,~     and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent~     cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells.~     Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover~     from the side effects of chemotherapy.~   "
136642|NCT01266434|"~     To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a~     signaling molecule for inflammation in inhaled steroid-treated asthmatics.~   "
136643|NCT01266421|"~     The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis~     therapy and of other hormonal treatments for endometriosis.~   "
136644|NCT01266408|"~     The study compares the risks of short- and long-term use of contraceptives containing~     drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium~     (metafolin) with the risks of short- and long-term use of other established oral~     contraceptives (OCs).~   "
136645|NCT01266395|"~     Observational study to know the Impact of morning symptoms in clinical control of COPD~     patients. 1200 patients will be included by General practitioners (GPs) and pneumologists.~     Objective: establish if there are differences in the impact of COPD on daily activities and~     morning symptoms measured through questionnaires of daily life activity (Capacity of Daily~     Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))~   "
136646|NCT01266382|"~     The purpose of the study is to examine the effect of a new biomechanical device and~     treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of~     patients with musculoskeletal and neurological disorders. Based on previous reports the~     investigators hypothesis that this therapy will have a positive effect on these~     measurements.~   "
136647|NCT01266369|"~     The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment~     of patients with mastocytosis with handicap and bearing activating point mutations in the~     phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).~   "
136648|NCT01266356|"~     This integrated research project is cooperated by an fully-experienced team of Taipei~     Medical University and National Institutes of Health. We hope that we can find out the~     disease of balance, anxiety and sick headaches through the translation of basic research to~     clinical diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).~   "
136649|NCT01266343|"~     The investigators wanted to reported the results of immediate anterior chamber paracentesis~     (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma~     (PACG). In this study, the investigators first divided patients into three sub-groups~     according to their initial intraocular pressure (IOP) for analyzing the differences of IOP~     control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and~     visual outcome between ACP and Mannitol infusion.~   "
136650|NCT01266330|"~     Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome will be randomized~     to inadequate dairy (<0.5 serving/day) and adequate dairy (3.5 servings/day) weight~     maintenance (eucaloric) diets for 12 weeks. Body weight will be measured weekly and body~     composition (via dual X-ray absorptiometry), insulin sensitivity index, plasma lipids and~     calcitrophic hormones will be measured at weeks 0, 4 and 12 of the dietary intervention.~     Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α~     and oxidized LDL and inflammatory stress will be assessed by measurement of IL-6, IL-15,~     MCP, C-reactive protein, adiponectin and TNF-α levels in plasma at 0, 1, 4 and 12 weeks). An~     additional global evaluation of diet-induced changes in cytokines will be conducted using~     cytokine protein arrays to profile relative changes in 36 additional potentially relevant~     cytokines. All data will be analyzed via two-factor (diet X obesity status) multivariate~     analysis of variance (MANOVA)~   "
136662|NCT01266174|"~     The purpose of this study is to determine if eltoprazine (as an adjunct to anti-psychotic~     medication) improves one or more aspects of cognitive impairment in adult schizophrenic~     patients.~   "
136663|NCT01266161|"~     The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets~     provide analgesic efficacy superior to placebo over 12-hour dosing intervals.~   "
136651|NCT01266317|"~     This is an open-label Phase I/II trial to assess the feasibility and safety of combined~     plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the~     outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this~     study are:~        1. To assess the feasibility and safety of combined PEX, rituximab, and conventional~          corticosteroid administrations for the treatment of hospitalized patients with acute~          IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular~          function during the treatment interval.~        2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid~          administrations for the treatment of hospitalized patients with acute IPF exacerbations~          on patient survival in comparison to historical controls. Patient survival for this~          investigation will be defined using the composite outcome of 60 day survival and/or~          survival to lung transplantation.~      Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all~     the study requirements will be enrolled in this study. A total of 10 subjects of both~     genders and all ethnic backgrounds with acute IPF exacerbations hospitalized at UPMC will be~     enrolled in this study.~   "
136652|NCT01266304|"~     The overall objective of this study is to develop and test an efficient self-report~     instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual~     factors important in healing.~      The initial phase of the study involves developing and refining an item bank. During the~     initial 'item bank development' phase, the investigators will run focus groups and cognitive~     interviews with individuals who participate in CAM and conventional medicine interventions.~      The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study~     involving focus groups and cognitive interviews.~      The next step of instrument development is called Calibration, and will involve~     administering the revised item bank to an internet sample and to persons who receive~     services in a CAM clinic and a conventional primary care setting. The items will be~     calibrated using item response theory and classical test theory. This will result in a~     computerized adaptive testing version of the instrument, as well as a static short form of~     the instrument.~      The final phase of the project will involve conducting initial validation studies of the~     instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL).~     The investigators will evaluate the convergent, discriminant, and predictive validity of the~     HEAL in a sample of 200 persons with chronic low back pain who are receiving physical~     therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity,~     the HEAL is expected to display moderate to large correlations with measures of similar~     constructs. The HEAL is expected to correlate modestly with self-report measures of general~     psychosocial functioning, in support of discriminant validity. Finally, HEAL score should~     account for a significant proportion of the variance in treatment outcome, supporting~     predictive validity.~   "
136653|NCT01266291|"~     This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin~     (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial~     epilepsy population for which the drug is approved. While enrolled on this trial, subjects~     will continue to take all of their normally prescribed medications, including their other~     antiepileptic drugs (AEDs).~      Alternatively, there is a prospective observational arm that subjects who are about to take~     Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who~     join this arm will not have any study visits and will not be asked to do anything~     specifically for the study. The study team will collect all study data from subjects'~     medical records only.~   "
136654|NCT01266278|"~     Shoulder complaints are very common in overhead athletes.The application of kinesiotape that~     keeps the shoulder in a correct position is used to avoid this.~      This could enlarge the dynamic size of the subacromial space and thus contribute to~     prevention of shoulder injuries.~      30 young elite handball players will participate in this study.Researchers will perform a~     number of measurements before and after applying kinesiotape to correct shoulder position:~        -  measurement of subacromial space~        -  measurement of 3D kinematics of shoulder~        -  assessment of shoulder posture~      Hypothesis of this study is that tape can influence the position of the scapula and is~     therefore able to change the size of the subacromial space.This results in a more efficient~     use of shoulder muscles with higher maximal strength as a result and maximizes shoulder~     mobility.~   "
136655|NCT01266265|"~     A surveillance of respiratory tract related adverse events in patients treated with~     Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies~   "
136656|NCT01266252|"~     Clinical experience with dexmedetomidine in the paediatric population is limited. Critical~     illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply~     extrapolate adult data for use in children but the investigators are in need of data on~     pharmacokinetics and pharmacodynamics in every paediatric subpopulation.~   "
136657|NCT01266239|"~     In study-1, the purpose of this study is to compare the long-term outcome of provisional~     stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis~      Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal~     growth on the strut and thrombus attachment.~   "
136658|NCT01266226|"~     The purpose of this study is to determine if autologous plasma (ACP) is beneficial for~     better and faster healing following an arthroscopic repair of the rotator cuff.~   "
136659|NCT01266213|"~     Fulvestrant is an ER antagonist with no agonist effects, which binds, blocks and degrades~     the ER. Fulvestrant is comparable to third-generation aromatase inhibitors in terms of~     efficacy and tolerability for patients who have progressed on prior tamoxifen therapy and~     past studies have found all three-third-generation AIs to be at least as good as tamoxifen~     in first-line metastatic therapy in postmenopausal women. Fulvestrant has been studied~     little in premenopausal women despite of its attractive mechanism of actions. The clinical~     effectiveness of fulvestrant as a treatment for advanced breast cancer has previously been~     demonstrated at the standard dose (AD; 250 mg/mo) in several phase III clinical trials in~     postmenopausal women. However, there is evidence to suggest that doses of fulvestrant higher~     than 250 mg may have greater pharmacodynamic activity against the ER pathway. Moreover,~     dose-dependent clinical activity has been observed for fulvestrant. The activity of a~     fulvestrant high-dose (HD; 500 mg/mo) regimen has been investigated in two recent studies. A~     pilot Japanese study showed fulvestrant HD to have clinical activity in the treatment of~     advanced or recurrent breast cancer, to be well tolerated, and to result in plasma levels~     approximately double those seen with fulvestrant low-dose. Subsequently, a neoadjuvant study~     comparing fulvestrant low-dose and high-dose reported that significantly greater Ki67 and ER~     downregulation was achieved with the high-dose compared with the low-dose regimen and that~     both doses were well tolerated. A recent randomized trial also showed superior outcome of~     high-dose fulvestrant than AI.~      Based on this rationale, we introduced high-dose fulvestrant with LHRH agonist as a~     randomized trial comparing with AI plus LHRH agonist and LHRH alone in premenopausal~     metastatic breast cancer patients who failed to tamoxifen treatment.~   "
136660|NCT01266200|"~     In this project, with unstable vertebral fractures, the microcirculation of the skin and~     muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will~     be evaluated in both conventional and in percutaneous minimally invasive technique (XIA~     versus Mantis) at the thoracolumbar junction.~   "
136661|NCT01266187|"~     Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated~     with a higher rate of postoperative complications in patients with resectable colorectal~     liver metastases as compared to only adjuvant FOLFOX and chemotherapy? Are there any~     differences for disease free survival between periand postoperative treatment in patients~     with >3 liver metastases or at least one metastasis > or = 5 cm in diameter?~   "
136666|NCT01266122|"~     This study will develop and pilot test a combined individual and group-level behavioral HIV~     prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing~     HIV risk within the context of broader psychosocial issues, including self-acceptance,~     substance use and social support.~   "
136667|NCT01266109|"~     Juvenile drug courts were developed in response to a perceived need to intervene more~     effectively with youth with substance abuse problems. Close collaboration between the court~     and substance abuse treatment provider is a defining component of the drug court model and~     is critical to helping youth achieve positive outcomes. Despite the proliferation of~     juvenile drug courts in recent years, however, evaluation of their capacity to reduce~     offender substance use and criminal activity has lagged. Moreover, the Institute of Medicine~     (IOM, 1998) and leading experts (McLellan, Carise, & Kleber, 2003) have presented a bleak~     picture of the nation's capacity to meet the treatment needs of substance abusing~     individuals. Although community-based programs provide the backbone of substance abuse~     treatment in the nation, their capabilities have not kept up with major scientific advances~     in the development and validation of evidence-based substance abuse interventions.~      Building on our research findings and experience regarding juvenile drug court outcomes as~     well as the transport of evidence-based practices to community treatment settings, the~     purpose of this study is to develop and test a relatively flexible and low cost strategy for~     enhancing the outcomes of juvenile drug courts by integrating components of evidence-based~     treatments into existing substance abuse services.~      Specifically, this project aims to:~      Aim 1: Adapt existing intervention and training protocols from evidence-based practices~     (i.e., Contingency Management for adolescent substance abuse; family engagement strategies~     from evidence-based treatments of juvenile offenders) for integration into juvenile drug~     court sites.~      Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and~     system level (e.g., intervention adherence, feasibility, retention and completion rates,~     consumer satisfaction, cost estimates) effects of implementing the intervention protocols in~     juvenile drug courts.~      Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if~     findings are supportive.~   "
136668|NCT01266096|"~     Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans~     use special dyes that are injected into a vein and can better localize possible cancer. The~     investigators have developed a new particle that can carry a radioactive dye to a very~     specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas~     of possible disease. This particle has been studied in mice and was safe.~      The particles will not treat the cancer and any images or information found during this~     study will not be used for your treatment. The information collected may be used to guide~     the design of future studies to detect and/or treat tumors.~   "
136669|NCT01266083|"~     The purpose of this study is to determine whether the WT1 vaccine causes an immune response~     which is safe and able to keep the leukemia from coming back. While vaccines have been used~     in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer~     like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of~     protein pieces that the immune system can recognize as abnormal. The doctor thinks that the~     WT-1 protein is important in AML/ALL and using some lab tests they are still able to find~     some of it in the bone marrow. By attacking this small amount of the protein they hope to~     get rid of any small amount of AML that is still in the body.~   "
136670|NCT01266070|"~     The goal of this clinical research study is to learn if dovitinib can safely be given to~     patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous~     system). The effects of this drug on the disease will also be studied.~   "
136671|NCT01266057|"~     The goal of this clinical research study is to find the highest tolerable dose of sirolimus~     or vorinostat that can be given in combination with hydroxychloroquine to patients with~     advanced cancer. The safety of these drug combinations will also be studied.~   "
136672|NCT01266044|"~     The goal of this clinical research study is to learn if acupuncture can help to prevent~     xerostomia (dry mouth) and improve the quality of life in patients who receive radiation~     treatment to the head and neck. This study will determine if one acupuncture treatment~     approach is more effective than another. Dry mouth is a common problem among cancer patients~     who have received radiation treatment to the head and neck.~   "
136673|NCT01266031|"~     The goal of this Phase I portion of this clinical research study is to find the highest~     tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with~     malignant gliomas. The safety of these drug combinations will also be studied.~      The goal of this Phase II part of this clinical research study is to learn if bevacizumab~     when given with or without vorinostat can help to control malignant gliomas. The safety of~     these drug combinations will also be studied.~   "
136674|NCT01266018|"~     This is an open-label, phase II study of ADI-PEG 20 in subjects with relapsed SCLC. ADI-PEG~     20 will be administered intramuscularly (IM) at a fixed dose of 320 IU/m2 once weekly for a~     4-week cycle. The primary objective is the assessment of clinical efficacy with a primary~     endpoint of tumor response by RECIST after 4 weeks. Secondary objectives are the assessment~     of safety, pharmacodynamics, and immunogenicity of ADI-PEG 20, as well as, clinical efficacy~     with a secondary endpoint of overall survival.~   "
136675|NCT01266005|"~     This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir~     therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV~     DNA negative and ALT normal) will have follow-up period for additional 48 weeks.~   "
136676|NCT01265992|"~     Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for~     the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4~     Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the~     effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in~     Sweden.~      This observational study is designed to collect data to evaluate safety and effectiveness~     during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD~     Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and~     costs associated with patient care.~   "
136677|NCT01265979|"~     The purpose of this study is to evaluate WB DWI as early predictor of response to treatment~     with regorafenib or placebo in patients with advanced metastatic GIST.~   "
136703|NCT01265641|"~     The purpose of this research study is to evaluate the effect of AZD1981 on the electrical~     activity of the heart, in particular when the heart muscle is relaxed during a heart beat~     cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which~     is well known to affect the electrical activity of the heart, but this effect is known to be~     at levels that are safe at the dose used in this study. The investigators will also compare~     the effects of AZD1981 with a dummy drug (placebo). The investigators will also be~     evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood~     circulation by collecting blood during the study.~   "
136704|NCT01265628|"~     Comparison of the differential luminance sensitivity (DLS) values at each test point~   "
136678|NCT01265966|"~     Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or~     if cortisol levels rise under only the most invasive of procedures, regardless of the type~     of anesthetic agent used. Animal data shows significant alterations in steroid intermediates~     under anesthesia regardless of the procedure performed. Prior studies in children show~     general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the~     effects of moderate and deep sedation on cortisol levels during different types of~     procedures are unknown. General medical practice varies considerably among providers; some~     provide stress dosing (extra and sometimes high doses of steroids) for sedation for both~     non-invasive and invasive procedures for patients with known adrenal insufficiency, but the~     doses given vary considerably. Others provide stress dosing only for the most invasive~     procedures in this population of patients. Currently there is no published normative data on~     changes in cortisol levels under moderate and deep sedation in adrenally sufficient~     children, so the normal response we are trying to mimic is unknown.~      We propose to measure salivary cortisol levels prospectively in adrenally sufficient~     children undergoing moderate and deep sedation to determine the normal cortisol response to~     the stress of sedation for both invasive and non-invasive procedures.~      Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary~     cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI,~     echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy)~     to determine what the normal cortisol response is to the stress of sedation during these~     procedures using various anesthetic agents.~      The primary outcome variable will be to determine peak salivary cortisol measurements during~     non-invasive and invasive procedures under different levels of sedation using various~     anesthetic agents, and correlate these with known norms in children to determine if the~     patient's hypothalamic-pituitary-adrenal axis is under stress.~   "
136679|NCT01265953|"~     The objective of the study is to identify mechanisms by which compounds found in cruciferous~     vegetables alter gene expression via epigenetic modifications (changes in gene expression)~     and may prevent prostate cancer development.~      The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous~     vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate~     cancer cells.~   "
136680|NCT01265940|"~     Urothelial carcinoma of the bladder mostly is chemically induced and represents the second~     prevalent urooncological disease. About 20% of newly diagnosed urothelial carcinoma cases of~     the bladder are already advanced or metastasized. Before 2008 2009 no second line therapy~     after failure of primary systemic therapy of advanced / metastatic disease was established~     outside of clinical trials. The actual standard for this situation was a supportive,~     symptomatic therapy. Vinflunine has demonstrated improved survival from 4.3 to 6.9 months~     (p=0.04), with an adequate disease control, good symptom control and with acceptable~     toxicity. Based on these results, this compound became standard se¬cond line treatment for~     refractory metastatic bladder cancer disease after failure of platinum-containing therapy.~     As the prognosis still remains poor, new treatment opportunities have to be explored.~      The target-specific therapy with Pazopanib suggests a positive influence of both inductive~     and perioperative treatment of solid tumors. Pazopanib has been approved by the FDA and the~     EMA for the treatment of advance renal cell carcinoma. Results for advanced urothelial~     carcinoma are missing so far as well as data on tolerability of the combination of both~     vinflunine and pazopanib. As the pharmacodynamic properties as well as the safety profile of~     both drugs are different, assumption is justified that there might occur additive efficacy~     effects without addition of adverse outcomes. Aim of the study thus is~        1. To define the maximum tolerated dose (MTD) of Pazopanib in combination with Vinflunine~          in a phase-I-setting and~        2. To further assess efficacy and safety of the combination at the MTD level in phase II.~      During the pase-I-part of the study different doses of pazopanib will be added to the~     standard vinflunine scheme in groups of 6 patients maximum. Dose escalation will only be~     performed in the next patient group if not more than one out of six patients shows~     dose-limiting toxicity. Each patient will be treated with the drug combination for a~     duration of two vinflunine cycles, that is six weeks.~      During the phase-II study new patients will be treated with the drug combination at~     maximum-tolerated dose until disease progression (assessed by RECIST 1.1 procedures).~   "
136681|NCT01265927|"~     A study to evaluate safety and biologic effects of giving GRN163L in combination with~     trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to~     therapy with trastuzumab.~   "
136682|NCT01265914|"~     The purpose of this study is to investigate the safety, tolerability and immunogenicity of~     ascending doses of a novel, universal flu vaccine, in healthy volunteers.~   "
136683|NCT01265901|"~     The primary objective of the phase III study is to investigate whether IMA901 can prolong~     overall survival in patients with metastatic and/or locally advanced renal cell carcinoma~     (RCC) when added to standard first-line therapy with sunitinib.~      Secondary objectives include a subgroup analysis of overall survival in patients defined by~     a certain biomarker signature, the investigation of progression-free survival, best tumor~     response, safety, and immunological parameters.~   "
136684|NCT01265888|"~     A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose~     (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by~     the GeNOsyl® System compared to placebo.~   "
136685|NCT01265875|"~     -  To determine if intravenous secretin administration in escalating doses three times~          daily for three days will improve the pain from CP at the time of infusion, after each~          infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.~        -  To validate the safety of intravenous secretin administration at the dosage indicated~          in this study.~   "
136686|NCT01265862|"~     The investigators aim to compare two different types of supraglottic devices for tracheal~     intubation in patients undergoing elective surgery under general anesthesia.~      The investigators hypothesis is that the use of the I-gel® supraglottic airway device~     associated with a GlideRite® endotracheal tube will result in an equal success rate of~     fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a~     GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be~     shorter.~   "
136687|NCT01265849|"~     The purpose of this study is to determine whether LI administered in combination with~     cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin combination prior to~     standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy)~     is safe and will increase the overall survival of subjects with previously untreated~     squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years~   "
136688|NCT01265836|"~     The purpose of this study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment (statin or combination) reaching the LDL-C goals according to the~     updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)~     guidelines.~   "
136689|NCT01265823|"~     W11-050 is a Mexican open label multicenter study that has been designed to further assess~     the safety and efficacy of adalimumab in the treatment of patients with active plaque~     psoriasis who have failed prior conventional systemic psoriasis treatment or who are~     candidates for systemic therapy.~   "
136705|NCT01265615|"~     We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for~     the management of chronic allograft dysfunction (CAD), protection and repair of kidney and~     heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can~     have some advantages if compare with calcitriol or cholecalciferol due to absence of~     calcemic and phosphatemic complications alongside with great beneficial potential.~   "
136706|NCT01265602|"~     The aim of this study is to determine the efficacy, safety and tolerability of LAS41007~     compared to a marketed reference product as well as to vehicle (topical application, twice~     daily, indication mild to moderate AK).~   "
136707|NCT01265589|"~     To research the effect of vitamin A to newborn respiratory distress syndrome by~     intratracheal administration with surfactant.~   "
136690|NCT01265810|"~     Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian~     target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high~     level of efficacy with acceptable tolerability. Currently, there are five approved targeted~     therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib~     (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma~     treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib~     will be included, too.~      Since this agents have dermatological adverse events in common, with oral mucositis (OM),~     hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side~     effect, we require evidence based management options to prevent and treat these adverse~     events. The incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%,~     temsirolimus 41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM~     is distinct from conventional mucositis and more closely resembles aphthous OM.~      Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse,~     became available to prevent or treat OM.~      The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes~     which include oral intake, swallowing function and pain associated with incidence of grade ≥~     1 oral side effects and the anticancer therapy cessation in patients treated with selected~     targeted anticancer therapy.~      Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either~     Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will~     switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks.~     Duration of oral side effects, severity, pain, dose of analgesics and tolerability will be~     assessed weekly with the VHNSS oral-specific questionnaire. Patients will be stratified by~     targeted anticancer agent and per tumor type (pre-defined cohorts). Objective severity of~     oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of subjective VHNSS~     scores with the objective NCI-CTCAE grade, sex, age, targeted therapy type, and cancer type~     will be conducted.~   "
136691|NCT01265797|"~     Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain~     relief in migraine patients. However, despite the number of CES studies done, many have been~     open label, single blinded, or have utilized a small group of patients.~   "
136692|NCT01265784|"~     This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared~     with ertapenem in the treatment of adult community-acquired complicated intra-abdominal~     infections (cIAIs).~   "
136693|NCT01265771|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     to diagnose arrhythmia in comparison with standard diagnostic procedure.~   "
136694|NCT01265758|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose~     cardiac arrhythmia.~   "
136695|NCT01265745|"~     Valortim is the name of the experimental drug that volunteers will receive in this study.~     Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved~     by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody~     (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the~     infection starts in the lungs). Valortim works by attaching itself to part of the anthrax~     toxin preventing the toxin from doing damage to cells. This study is being conducted to see~     if Valortim given over 120 minutes is safe and tolerable. This study will take place in five~     parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study),~     Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time~     after you receive the study medication) and Final Visit.~   "
136696|NCT01265732|"~     This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when~     respectively given orally as a single dispersion dose and a single dose of a suspension. The~     suspension is the test formulation and the dispersion is the formulation with which the~     novel preparation will be compared.~   "
136697|NCT01265719|"~     This is a non-interventional, prospective, longitudinal cohort study. A total of 150~     pediatric subjects with glaucoma or elevated intraocular pressure, including 75~     latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects,~     will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a~     non-interventional study, the study subjects' continued use of latanoprost and assessments~     of ocular events will be obtained through the routine medical follow-up with treating~     ophthalmologists or other designated members of the medical care team.~   "
136698|NCT01265706|"~     This study is performed to observe the incidence of major cardiovascular events in Korean~     patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.~   "
136699|NCT01265693|"~     The aim of the study is to assess the effect of antiviral therapy with pegylated interferon~     alpha for hepatitis C and B on auditory disability as there are reports in the English~     literature on auditory disability caused by interferon alpha.~   "
136700|NCT01265680|"~     All patients operated on at the European Hospital Heart surgery Division will be randomized~     to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or~     control.~      Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin~     level in the patient on postoperative day four.~      Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well~   "
136701|NCT01265667|"~     Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16~     weeks. All subjects will receive open-lable CF101 in weeks 17-32.~   "
136702|NCT01265654|"~     Breast cancer is the leading type of cancer in women. Although big advance in diagnostics~     and treatment of early and breast cancer has been made in recent years breast cancer still~     has a significant mortality rate. A number of treatment modalities exist for postmenopausal~     women with advanced breast cancer. The treatment modality is chosen based on patient and~     tumour characteristics. Hormonal treatment is preferred and recommended in women with~     hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an~     established method of monitoring systemic therapies in various cancers. Tumor markers CA~     15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic~     breast cancer. Blood levels of tumor markers are widely used to assess response/progression~     to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in~     clinical studies. Change of therapy in clinical study is usually done when progression based~     on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with~     chemotherapy that can last several weeks. Also when a new therapy is started spurious early~     rises may occur. Therefore rising levels of tumor markers during the first weeks of new~     hormonal therapy are not necessarily sign of progression and should not be the only guidance~     for treatment change. Evidence of treatment efficacy form clinical studies and treatment~     change is based on imaging techniques.~   "
136709|NCT01265563|"~     The study is done to find out whether the combined use of the nutritional supplements~     N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein~     and oxidative damage (damage to cells and organs often compared to fast aging) in patients~     with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.~   "
136710|NCT01265550|"~     Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult~     Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors~     (PPIs), which block gastric acid production, are the most effective medications for GERD,~     and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do~     not prevent the reflux of non-acidic material and do not completely eliminate esophageal~     acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of~     patients treated with PPIs. Recent studies using the new technique of esophageal pH/~     impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have~     shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or~     non-acidic) in approximately one-half of patients. For those patients, an antireflux~     operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the~     efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients~     with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can~     prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g.~     neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic~     antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus~     baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of~     heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure~     by esophageal pH/impedance monitoring.~      Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen~     fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients~     who, while on PPIs, have persistent episodes of heartburn that are associated with reflux~     episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring,~     and to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To~     determine the frequency with which non-GERD disorders underlie PPI failure, 2) To~     determine the frequency of functional gastrointestinal symptoms, anxiety and depression in~     patients who have persistent heartburn while on PPIs, 3) To determine whether functional~     gastrointestinal symptoms, anxiety and depression is associated with the outcomes of medical~     and surgical therapies, and 4) To determine whether the outcome of Nissen fundoplication is~     associated with adherence to technical aspects of the operation.~      Study Design: At 15 VA medical centers, there will be a 30-month recruitment period to~     enroll 393 patients with heartburn that is refractory to PPI therapy. Patients will have~     their baseline GERD symptoms scored using the GERD Health-Related Quality of Life~     (GERD-HRQL) index, and will have endoscopy, esophageal manometry and esophageal pH/impedance~     monitoring while on PPI therapy. Patients who have episodes of heartburn that are associated~     with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance~     monitoring will be randomized to one of three treatment groups: Surgical Treatment~     (laparoscopic Nissen fundoplication), Active Medical Treatment (omeprazole and baclofen~     initially; desipramine for baclofen failures) or Placebo Medical Treatment (omeprazole,~     placebo baclofen, placebo desipramine). All patients will have quarterly clinic visits for~     symptom scoring and laboratory testing. At one year, patients will have a final symptom~     scoring and repeat endoscopy, esophageal manometry and esophageal pH/impedance monitoring.~     Treatment success will be defined as 50% improvement in the GERD-HRQL score at 12 months.~     Patients also will complete the Hospital Anxiety and Depression Scale (HADS), Rome III~     Functional GI Disorders Questionnaire and the Short-Form Health Survey (SF-36) at baseline~     and one year. The results will be correlated with treatment outcomes.~   "
136711|NCT01265537|"~     While the incidence of acute rejection and early graft loss have improved dramatically with~     the advent of newer immunosuppressant medications, improvements in long-term patient and~     allograft survival after kidney transplantation have not been achieved. The specific drug~     combination that provides the best outcomes with the least amount of side effects is not~     known. Each kidney transplant center uses the combination of drugs that they believe is~     optimal. This study is about identifying whether drugs that are currently approved for use~     in kidney transplantation can be used in a new combination safely and with potentially fewer~     side effects than the drug combinations that are currently used at St. Paul's Hospital and~     other transplant centres.~   "
136712|NCT01265524|"~     The purpose of this study is to determine the effects of CLP on serum potassium and signs~     and symptoms of fluid overload in heart failure patients with chronic kidney disease.~   "
136713|NCT01265511|"~     This study will examine the effectiveness of 28 days of triple combination therapy including~     SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An~     additional 20 weeks of treatment with the currently approved standard of care will be~     offered to all participants. The Week 24 visit will be the last on-study visit. After the~     Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue~     treatment with standard of care for an additional 24 weeks (out to Week 48) under the care~     of their Principal Investigator.~   "
136714|NCT01265498|"~     Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks~     to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in~     improvement in their liver disease as measured by changes in the nonalcoholic fatty liver~     disease (NAFLD) activity score (NAS).~   "
136715|NCT01265485|"~     This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be~     participating in this study. This study is composed of 2 parts:~      Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an~     elected dose. A screening will be used to determine patients' suitability for inclusion in~     the trial. Within one week after the screening visit, subjects who meet all inclusion~     criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose~     escalation. During this part, patients will undergo rectal manometry to determine anal~     pressure at baseline. Afterwards coated suppositories at various drug concentrations will be~     inserted and follow up manometries will be performed to determine response.~      Patients that presented with an increase in rectal resting pressure without adverse events~     will enter the second part of the study. In this part, patients will be administered with a~     coated suppository, at a dose found at part 1 of the study to cause significant anal~     contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and~     5 hours after insertion.~      Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes~     after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after~     administration.~   "
136716|NCT01265472|"~     Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer~     membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO~     expression in the skin correlates with cell proliferation and differentiation. Many studies~     have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon~     cancer, and others, was also found to correlate with more aggressive cancer behavior.~     Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO~     levels in solid malignancies as compared to normal tissues. It is assumed that this~     aberration can be found in cuntaneous malignancies as well. The occurrence of this~     aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous~     malignancy, and in malignancies in general. Methods: The study will be carried out on~     surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of~     the surgical routine treatment. The excision will be made in elliptic shape including the~     lesion and a part of normal skin surrounding it. A sample will be taken from the central~     part of the lesion and from the external extremity of the normal tissue. Western Blot will~     be conducted to detect the expression of TSPO. Binding activity with the TSPO specific~     ligandwill also be determined. Expected Results: We expect to observe either (a) a higher~     level of TSPO expression and a lower binding activity in malignant tissue compared with~     healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity~     in malignant tissue compared with healthy control tissue. Importance: Until today, only a~     very small number of studies have examined TSPO in cutaneous malignancies, and these only~     examined TSPO expression. Our study will also measure the binding activity of TSPO in~     cutaneous malignant tissues compared to normal tissues~   "
136717|NCT01265459|"~     The purpose of the study is to assess the safety and efficacy profiles of new~     single-injection volumes of Durolane in patients with knee OA.~   "
136718|NCT01265446|"~     This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg +~     cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2~     mg lozenge in the treatment of sore throat due to a common cold.~   "
136719|NCT01265433|"~     The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the~     mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that~     regulates gene expression and causes cell growth. Mesothelioma tumors generally have high~     levels of WT1.This study was originally designed to have two treatment groups. One group~     received non-specific immunotherapy with medications called Montanide and Sargramostim~     (Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has~     stopped The other group, which continues receives more specific immunotherapy with the WT1~     vaccine plus Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with~     vaccines because they have a general effect in boosting the immune response. Some~     researchers believe that this general increase in the immune system may have some effect in~     treating cancer. Some studies using GM-CSF with melanoma vaccines have suggested that it~     could lessen the effects of the vaccine. The addition of the WT1 proteins makes this therapy~     more directed to mesothelioma. The combination of WT1 vaccine with Montanide and GM-CSF has~     been tested in a prior trial including 9 patients with advanced mesothelioma. In that trial,~     the vaccine was safe and caused an immune response.~   "
136720|NCT01265420|"~     This study will evaluate the efficacy and safety of clostridial collagenase injections for~     treatment of Dupuytren's contracture of the thumb and first web space. The investigators~     hypothesis is that clostridial collagenase will have safety not significantly different to~     that demonstrated in Phase III clinical trials, and will be effective in significantly~     reducing the degree of thumb contracture.~   "
136721|NCT01265407|"~     Background:~      - Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than~     a quarter of all outpatient visits at health facilities, 20 percent of hospital admissions,~     and about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women,~     and HIV-infected individuals bear the greatest burden of disease. To provide baseline~     information for future malaria vaccine research, development, and testing, researchers are~     interested in collecting malaria infection data from the Rakai district in southern Uganda.~      Objectives:~      - To assess the epidemiology of malaria infection among children aged 6 months to less than~     10 years and adults living in same households with children in Rakai district, Uganda.~      Eligibility:~      - Children between 6 months and 10 years of age, as well as their primary caregiver and an~     additional randomly selected adolescent or adult resident of the household, from the Rakai~     district of Uganda.~      Design:~        -  Participants will have monthly household visits for a 1-year surveillance period.~        -  Each visit will include a structured interview/questionnaire of the primary caregiver~          or legal guardian of the child and clinical and laboratory assessments of each child,~          the primary caregiver, and the additional adolescent or adult resident of the~          household. The questionnaire will ask about malaria treatment and prevention measures.~        -  Children will provide a blood sample for testing. Individuals (children or adults) who~          are diagnosed with malaria or anemia during the course of the study will be recommended~          for treatment.~        -  Researchers will also track usage of the district health clinic and hospital services~          to link medical records for study participants.~   "
136722|NCT01265394|"~     Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease~     (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this~     study is to determine how well the study drug performs in young healthy subjects.~   "
136723|NCT01265381|"~     Background:~      - The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of~     Health have been studying cancer risks and outcomes in individuals who participated in the~     decontamination clean-up process following the Chornobyl nuclear accident. Some of these~     individuals were exposed to external radiation at various levels, as well as radioactive~     iodine that may have affected the thyroid and increased the risk of developing thyroid~     cancer. Because more individual and comparative data are needed on the affected populations~     and clean-up workers associated with the Chornobyl accident, researchers are interested in~     collecting personal information and saliva samples from Chornobyl clean-up workers who have~     been diagnosed with thyroid cancer.~      Objectives:~      - To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up~     workers and collect saliva samples for an initial study.~      Eligibility:~      - Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with~     thyroid cancer.~      Design:~        -  Participants will complete a standardized questionnaire during a personal interview.~          The questionnaire will ask for detailed information on the following areas of study:~        -  Work history, conditions, and activities inside the 70-km clean-up and radiation~          calculation zone.~        -  Residence history inside and outside the 30-km exclusion zone.~        -  Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from~          radioiodine fallout).~        -  Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol~          consumption, family cancer history).~        -  Participants will provide a saliva sample for pilot study testing.~   "
136724|NCT01265368|"~     This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a~     intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients~     with advanced renal cell carcinoma.~   "
136725|NCT01265355|"~     Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The~     investigators hypothesize that use of a food based prophylactic will decrease incidence of~     rotavirus infection in young children in south India, prevent intestinal damage and overall~     result in lower infection rates and better gut function. This trial will evaluate the~     efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or~     antibody fragments expressed in yeast or placebo are given daily as a food supplement to~     children between the ages of 6 and 12 months. The children will followed for one year and~     rates of rotavirus diarrhoea, antibody responses and gut function will be compared between~     children receiving antibody fragments or placebo.~   "
136726|NCT01265342|"~     Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as~     symptomatic treatment of upper respiratory infections without evidence of efficacy.~      The purpose of this study is to evaluate the efficacy of beclomethasone (administered by~     nebuliser twice a day) in preventing viral wheezing in pre-school children who had had~     episodes in the preceding 12 months.~   "
136727|NCT01265329|"~     In spite of the achievements and developement of the assisted reproduction techniques in the~     last years, there is still an elevated percentage of unsuccessful treatments, needing~     sometimes repeated attempts to reach pregnancy.~      The molecular physiology of sperm is being better characterized, and some reports have~     demonstrated the implication of different molecular processes in the pathophysiology of male~     infertility.~      Recently, different sperm selection methods have been based on these molecular differences,~     showing a better quality of the sperm population after selection.~      The main objective of this research project is to clinically apply these techniques in order~     to increase the pregnancy rates per cycle in infertile couples attending assisted~     reproduction treatments.~   "
136728|NCT01265316|"~     Outcomes for pediatric cardiopulmonary resuscitation (CPR) are suboptimal. CPR quality is~     directly related to resuscitation outcome, yet numerous deficiencies in CPR quality have~     been documented in adult studies. While similar deficiencies can be expected in pediatric~     resuscitation attempts, there is little to no data evaluating the existing quality of CPR~     performed during resuscitation attempts. Therefore, the objective of this study is to~     quantitatively evaluate existing CPR quality using a Q-CPR compression sensor manufactured~     by Philips Medical Systems with technology from Laerdal Medical.~   "
136729|NCT01265303|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring~     and signal analysis using advanced GSM telemetric technology to prescribe the most~     appropriate treatment of arrhythmia.~   "
136730|NCT01265290|"~     The purpose of this study is to assess efficacy of prolonged Full Disclosure~     electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology~     to diagnose syncope in comparison with standard diagnostic procedure~   "
136731|NCT01265277|"~     When babies start day care, they experience many changes, some of which may affect their~     risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress~     or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.~   "
136732|NCT01265264|"~     The purpose of this study is to determine whether ulodesine and allopurinol combined for 12~     weeks are effective in treating gout in patients who are not adequately responding to~     allopurinol alone.~   "
136733|NCT01265251|"~     A computerised neuropsychological test battery to be used as a standardised tool assessing~     the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was~     developed. The aim of this study is to investigate the reliability, validity and feasibility~     of the battery.~   "
136734|NCT01265238|"~     Spastic equinovarus foot (SEF) is a major cause of disability in stroke patients. Treatments~     may include physical therapy, orthosis, botulinum toxin (BTX) injections, selective tibial~     neurotomy and tendon lengthening and/or transfer.~      Until now, no study has been conducted to assess the result of neuro-orthopaedic surgery in~     the treatment of SEF.~      The aim of this study is to evaluate the benefit of neuro-orthopaedic surgery (selective~     neurotomy and/or Achilles tendon lengthening and/or tibialis anterior transfer) in case of~     SEF according to the 3 domains of the International Classification of Functioning,~     Disability and Health (ICF)of the World Health organisation (WHO)~   "
136735|NCT01265225|"~     The goal of the investigators study is to identify a prognostic marker that will evaluate~     the probability of recurrence in patients with stage 0-II breast cancer following surgery to~     remove the tumor.~   "
136736|NCT01265212|"~     HPV infection is associated with cervical and other anogenital cancers. HPV may also be~     associated with the development of prostate cancer. The purpose of the study is to determine~     the prevalence of HPV infection in men living in South Dakota.~   "
136737|NCT01265199|"~     The main purpose of this study are to determine the maximum dose of AT-406 that can be~     safely given in combination with cytarabine and daunorubicin to humans. Other purposes are~     to determine how the drug is broken down in the body, and to see if there are any molecular~     interactions that can help determine how AT-406 works. Side effects will also be studied in~     an effort to make sure that this drug is safe to take.~   "
136738|NCT01265186|"~     Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to~     numerous painful procedures and often dependent on mechanical ventilation. Mechanical~     ventilation as well as painful conditions require a sufficient analgesia and or an~     accurately regulated sedation. Newborns incapable of self-report are therefore dependent on~     the assessment of the infants level of pain and sedation by the treating team.~      The aim of this prospective, controlled, observer-blinded clinical trial is to compare the~     performance of two EEG based methods and a clinical sedation scale to measure the level of~     sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are~     compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation~     between the clinical sedation score (N-PASS), the bispectral index (BIS) and the~     amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen~     control patients are enrolled and observed for up to 72h.~   "
136739|NCT01265173|"~     Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver~     cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several~     antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is~     unclear which drug is most effective. Our aim of study is to compare the efficacy of the~     three current antibiotics for the treatment of SBP in patients with liver cirrhosis.~      The primary hypothesis is that the efficacy of all the antibiotics will not significantly~     different. This is non-inferiority trial.~   "
136740|NCT01265160|"~     Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome~     of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study~   "
136741|NCT01265147|"~     This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which~     one is better efficacy and security in nasopharyngeal carcinoma.~   "
136742|NCT01265134|"~     The purpose of this study is to measure the ability of balance controlling and test the~     evaluation of clinical trials with different arch insoles. The investigators want to find~     out the difference and efficacy of arch insoles in the dynamic postural control for the~     elderly.~   "
136743|NCT01265121|"~     Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This~     disease is linked to disturbance on the carbohydrate metabolism increasing the rates of~     diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic~     clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure~     device (CPAP), on the insulin resistance.~   "
136744|NCT01265108|"~     During alveolar hypoxia, for example at high altitude or in patients with respiratory~     disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might~     limit exercise performance. Intravenous iron supplementation has recently been shown to~     reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary~     hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized~     that intravenous iron supplementation would enhance exercise capacity during alveolar~     hypoxia.~   "
136745|NCT01265095|"~     The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome~     monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an~     important healthcare-associated pathogen due to rapid spread, limited options for therapy~     and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE~     infections not only contribute to more hospital cost and longer length of hospital stay, but~     also higher attributable mortality compared to those caused by vancomycin susceptible~     enterococci. Two different meta-analyses have shown that vancomycin resistance is an~     independent predictor of death among patients with enterococcal bloodstrem infections~     (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug~     Administration for the treatment of serious VRE infections. Though several studies have~     conducted to find the possible mortality predictors, but none has used bacterial load as a~     marker.~      Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship~     between high bacterial load and mortality. However, it may take more than two days before~     culture result available, and the sensitivity of culture is greatly affected by~     antimicrobial treatment. Real-time PCR has been demonstrate good performance in early~     detection of bacteremia, and theoretically is less affected by antimicrobial usage. However,~     using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.~      The objective of this study is to establish a quantitative method to measure the amounts of~     VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load~     in blood results in higher mortality among patients with VRE BSIs.~      Primers and probe of VRE Real-time PCR will be constructed first. The investigators will~     prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored.~     Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome~     and the association of bacteria load of VRE bacteremia will be analyzed.~   "
136746|NCT01265082|"~     The following is the investigators hypothesis regarding the pruritus of BP patients during~     remission. Anti-BP 180 IgE binds to dermal mast cells, inducing their activation and~     secretion of mediators after being cross-linked by antigens. Among mediators, histamine~     directly induces itching and vessel changes, whereas tryptase potentiates itching and vessel~     changes in an indirect way through the actions of neuropeptides. Tryptase stimulates neurons~     which in turn secrete neuropeptides.~   "
136747|NCT01265069|"~     Currently, a 10-day concomitant therapy has been reported to be equally effective and safe~     to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy.~     To our knowledge, there has been no report concerning the efficacy of this regimen used as a~     rescue therapy.~      The aims of this study are:~        1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue~          regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
136748|NCT01265056|"~     Burn patients have extreme pain. Opioids are the main agents used for analgesia. Opioids can~     have several adverse outcomes and have been only partially effective in controlling the pain~     assoicated with burn injury. Agents directed at neuropathic pain are rarely used acutely in~     thermal injury. However, there is mounting evidence from small randomized clinical studies~     that the administration of the anticonvulsant Gabapentin decreases acute burn pain and has~     an opioid sparing effect. We therefore propose a single center study to fruther assess the~     efficacy of neuropathic agents in controlling the pain associated with acute thermal injury.~   "
136749|NCT01265043|"~     The main aim of this oral health intervention project is to compare the effect of providing~     1) professional oral hygiene instruction alone versus 2) professional oral hygiene~     instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene~     instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the~     oral health condition, the general health condition and health-related quality of life~     (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An~     additional aim is to assess potential longer term oral intervention-related health and HRQoL~     outcomes.~   "
136750|NCT01265030|"~     Desmoid-type fibromatosis (or desmoid tumor) represents an intermediate grade neoplasm with~     a striking predilection for locally invasive growth and recurrence following resection. It~     occurs in children as well as young adults. As a typically localized disease, the historical~     standard of care for treatment has been surgical resection, with or without ionizing~     radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy~     has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the~     Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic~     chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These~     were largely empirical treatment strategies or based on somewhat anecdotal observations. By~     better understanding desmoid tumor biology, even more effective therapy targeting a~     particular protein that is central to the disease can be developed.~      Desmoid tumor is well-known to be associated with deregulation of the Adenomatous Polyposis~     Cell/beta-catenin (APC/β-catenin pathway). This is true of familial cases associated with~     Gardner's Syndrome and also in sporadic desmoid tumor, nearly all of which display~     histological or molecular evidence of Adenomatous Polyposis Cell/beta-catenin (APC~     β-catenin) pathway activation (Alman et al., 1997; Lips et al., 2009). Several new pieces of~     evidence support the concept that deregulation of the mammalian target of rapamycin (mTOR)~     cell proliferation/survival pathway may play an important role in tumor biology when the~     APC/β-catenin pathway is disrupted. Sirolimus, a drug that inhibits mammalian target of~     rapamycin (mTOR), is currently being evaluated as an anti-cancer agent in a variety of tumor~     types, but it has not been previously studied in desmoid tumor.~      The investigators are conducting this pilot study to begin to explore whether mTOR~     inhibition may be beneficial for children and young adults with desmoid tumor.~   "
136751|NCT01265017|"~     This is a randomized, double-masked, placebo-controlled, single-center study to evaluate~     stimulated C-peptide secretion after exogenous administration of mild immunosuppression and~     growth-promoting factors to women with preexisting T1DM who had a decline in insulin~     requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will~     be enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a~     parallel group design.~      Participation for individual subjects will consist of an initial Screening Visit, a 2-week~     baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit~     at the end of the treatment period (week 6), and a follow-up visit 2 weeks after study~     treatment discontinuation.~      Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8~     hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25~     mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).~   "
136752|NCT01265004|"~     This project investigates microcirculation in skin and tendon after a rupture of the~     Achilles tendon. Three different treatments are compared: stitches of the tendon,~     fibrin-glue and the combination of both.~   "
136753|NCT01264991|"~     BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of~     the most affected joints. The meniscus plays an important role in the development of knee~     OA. It is unclear whether a degenerative meniscus tear is a risk factor in developing knee~     OA or a sign of the disease. The standard treatment for a degenerative meniscus tear is an~     arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at~     high risk of later developing OA. Earlier studies have shown a significant placebo effect~     from surgical procedures, in general, and an arthroscopic knee procedure, in particular.~      PURPOSE The overall purpose of this study is to gather information that might lead to a~     reduction in the development of OA in middle-aged patients. The investigators hypothesise~     that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect~     measured on self-reported outcomes, and that the meniscectomy contributes to the development~     of knee OA as seen on radiography.~      METHODS The investigators will include 100 patients aged from 35 to 55 years with an~     MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4~     knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either~     a standard APM procedure or a sham procedure and both groups will receive standard~     post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS~     score, and a functionality test after 3 and 24 months.~   "
136780|NCT01264640|"~     The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor~     (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the~     impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of~     Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.~   "
136754|NCT01264978|"~     The aims of this study are:1.To evaluate the utility of quadriceps RMNMS (repetitive~     magnetic neuromuscular stimulation) in the evolution of COPD patients after hospital~     admission for acute exacerbation.2 To evaluate the time schedule of recovery changes in~     muscle parameters ,exercise capacity and quality of life after acute exacerbation. 3.To test~     the use of this new method of training in acute clinical situations. Patients: COPD patients~     admitted to the Hospital with acute exacerbation. Group 1: RMNMS Treatment .Group 2 : sham~     RMNMS treatment. Randomized assignment by minimization method. PROTOCOL Training Group: 10~     days after discharge and during 8 weeks, 2-3 days/week.~      Measures: Spirometry, Plethysmography ,Diffusion Test. Main outcomes: Exercise test (Six~     minutes walking distance). Muscle function: MVC. Health related quality of life.~   "
136755|NCT01264965|"~     To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older~     persons with no and mild to moderate cognitive impairment and persistent moderate or higher~     intensity non-cancer lower extremity arthritis pain; and Describe the association of change~     in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and~     brief physical performance measure) and to determine if cognitive status modifies this~     relationship.~   "
136756|NCT01264952|"~     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with~     bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I~     and II.~      The study will include 10-15 patients with colorectal cancer with synchronous or~     metachronous liver metastases, but electrochemotherapy will be performed on metastasis not~     more than 3 cm in the largest diameter.~      Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and~     ultrasonography (US) in a monthly interval. Two or three month after the first operation the~     treated and untreated metastases will be resected and through histological analyses~     performed.~      The secondary objectives of the trial are to quantify the impact of the treatment on the~     patient's quality of life, tolerance to the therapy and suitability for larger study to be~     conducted.~   "
136757|NCT01264939|"~     The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled,~     parallel-group study to evaluate the safety and efficacy of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged~     12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic~     despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the~     approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).~   "
136758|NCT01264926|"~     The Objective is to evaluation the difference between the upper end of the Humerus head and~     the bottom end of the Acromion in sitting and lying, and to examine this difference to~     shoulder pain.~   "
136759|NCT01264913|"~     The overall goal of the present application is to test the hypothesis that shift workers,~     who are chronically exposed to circadian misalignment and sleep loss, have a higher~     cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree~     of circadian misalignment both predict their elevated cardio-metabolic risk.~   "
136760|NCT01264900|"~     Aggressive behavior is a leading worldwide public health problem. Despite this, relatively~     little is known about how to best treat individuals who are highly angry and aggressive. A~     rich literature suggests that aggression is associated with a tendency to interpret~     situations as threatening or hostile even when they are not. This process is governed by a~     prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce~     these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive~     behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying~     hostile biases associated with affective aggression. To assess the efficacy of this~     treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of~     either CBAT or supportive psychotherapy. All subjects will monitor their anger and~     aggressive behavior throughout the treatment electronic diaries. Subjects will also complete~     questionnaires and computer tasks to assess anger, hostile biases and related processes~     1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends.~     In addition, to understand the effects of CBAT on the brain, subjects will have their brains~     scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and~     complete computer tasks. The brain scans will occur once before treatment starts and once~     after treatment ends.~      Our hypotheses are:~        1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.~        2. CBAT will decrease limbic activation and increase prefrontal activation to emotional~          pictures more than supportive therapy.~   "
136761|NCT01264887|"~     The purpose of this trial is the characterization of the long term safety profile and~     long-term dose requirements of tapentadol PR (prolonged release) in patients with malignant~     tumor-related pain. In the United States the prolonged-release formulation is also referred~     to as the extended-release formulation.~   "
136762|NCT01264874|"~     The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence~     in resected stage II melanoma patients.~   "
136763|NCT01264861|"~     This is a study of safinamide, an investigational drug for Parkinson disease (PD).~     Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It~     is theorized that safinamide acts by increasing the available dopamine in those areas of the~     brain where dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the~     brain is involved in controlling body movements. Safinamide has been extensively studied in~     animals, and has been shown to increase the level of dopamine in these animals. Safinamide~     has also been tested in patients with Parkinson disease. The goal of this research trial is~     to see if safinamide is safe and well tolerated and to better understand how it affects the~     dopamine system in the brain in individuals with Parkinson disease. Data from this trial may~     provide essential information about the effectiveness and safety of these doses of~     safinamide in patients with early Parkinson disease, who are already receiving a stable dose~     of their normal Parkinson disease treatment.~   "
136764|NCT01264848|"~     The aim of this study is to assess the efficacy of endovascular treatment (balloon~     angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis~     patients.~   "
136765|NCT01264835|"~     This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure~     duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson~     hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.~   "
136767|NCT01264809|"~     The prevalence of type 2 diabetes is high and expected to increase dramatically in~     worldwide, in France and especially in the French West Indies.This chronic disease is~     associated with premature mortality and various debilitating complications which can be~     prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management~     includes lifestyle modification and medication. Despite numerous studies supporting the~     benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80%~     of this population remain sedentary. Promotion of physical activity in current diabetes care~     seems to be inadequate.~      The aim of this randomized controlled trial is to evaluate the medium-term effectiveness~     (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients~     with Type 2 diabetes.~   "
136768|NCT01264796|"~     The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a~     comprehensive, culturally tailored DM management intervention, in improving glucose~     outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving~     self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible~     infrastructures for the dissemination of valid and effective education materials to a wider~     population of KAI with type 2 DM in the US (e.g., audio-visual education materials,~     web-based intervention materials, mobile telephone-based intervention materials) and to~     explore the feasibility and acceptability of each dissemination module, utilizing the~     delayed intervention group participants. The secondary aims are to obtain preliminary~     cost-effectiveness data related to the proposed intervention, including cost estimates for~     this type of DM intervention, and to establish a systematic, long-term dissemination plan,~     including documenting effective methodologies, to facilitate faster translation of research~     findings and products to direct consumers in non-research settings.~   "
136769|NCT01264783|"~     The objective of this study is to evaluate the safety and tolerability of RNS60 administered~     intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three~     escalating rates for 48 hours for each rate.~   "
136770|NCT01264770|"~     The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid~     arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are~     Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an~     inadequate response to DMARDs. The study will last for approximately six months~   "
136771|NCT01264757|"~     This feasibility study specifically addresses the issue of adapting US dietary guidelines~     physical activity recommendations to the population of the Lower Mississippi Delta. The~     hypothesis is that including a pedometer as a self-monitoring tool as part of adapted~     physical activity guidelines will result in greater immediate increases in physical activity~     (as monitored by an accelerometer) than an education program alone.~   "
136772|NCT01264744|"~     The purpose of the study is the identification of chromosomal aberrations in urine samples.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classification of UroVysion FISH stained Urine samples.~   "
136773|NCT01264731|"~     The purpose of the study is to determine 1) the safety of administration of topical 5%~     imiquimod cream with or without administration of a peptide-based vaccine in patients with~     cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of~     melanoma metastasis, with or without vaccine, increases a) endothelial expression of~     E-selectin and b) T cell infiltration.~   "
136774|NCT01264718|"~     9.6 million US Children (13%) have no health insurance, Latino and African-American children~     account for 57% of uninsured children, although comprising only 37% of all US Children.~     Studies show that being uninsured has a negative impact on children's health, healthcare,~     and mortality, however, insuring children results in improved health and healthcare. About~     70% of uninsured US children (6 million) are eligible for but not enrolled in Medicaid or~     the Children's Health Insurance Program (CHIP), innovative strategies are needed to insure~     more children and eliminate disparities. This is the first randomized controlled trial~     comparing the effectiveness of parent mentors (PMs) to traditional Medicaid/CHIP outreach~     and enrollment in insuring uninsured minority children. The primary study aims are to~     evaluate whether PMs are more effective and more cost-effective than traditional~     Medicaid/CHIP outreach and enrollment in uninsured children. The secondary aim is to~     determine whether children who obtain health insurance experience improvements in healthcare~     access, health status, use of services, and other health outcomes.~      Subjects will be 300 Dallas County uninsured and Medicaid/CHIP eligible Latino and~     African-American children (90% of insured children) and their parent/guardian. Subjects will~     be randomized to PMs or a control group receiving traditional Medicaid/CHIP outreach. PMs~     are experienced parents who have a child currently covered by Medicaid/CHIP. PMs will~     undergo intensive training, and will be paired with intervention subjects and their~     families, for whom they will provide information on Medicaid/CHIP eligibility, help~     complete/submit insurance applications, act as a liaison, and assist in maintaining~     coverage. Primary outcomes will include obtaining health insurance, coverage continuity,~     time interval to obtain coverage, parental satisfaction with the process of obtaining~     insurance and costs; secondary outcomes will include access to care, health status, use of~     services, quality of life, Parental satisfaction, financial burden, and missed~     school/parental work days. Subjects will be contacted monthly for 1 year to monitor outcomes~     by a blinded assessor. Achievement of study aims has the potential to contribute to reducing~     racial/ethnic disparities, and advancing knowledge and practice of child health policy. This~     intervention could serve as a national model for insuring uninsured children and reducing~     racial/ethnic disparities in insurance coverage.~   "
136775|NCT01264705|"~     This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of~     bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This~     study will be activated at the UT Southwestern Medical Center, comprised of The Harold C.~     Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland~     Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to~     surgical resection or orthotopic liver transplantation or is metastatic in nature.~   "
136776|NCT01264692|"~     The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral~     administration of ACT 280778 on DBP compared to placebo after 28 days.~   "
136777|NCT01264679|"~     To evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA)~     with ferumoxytol.~   "
136778|NCT01264666|"~     Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea~     Flavor liquor may be beneficial to CVD risk factors postprandially.~      Design: three-way crossover design with one week wash time.16 young men were included to~     consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45%~     alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours~     postprandially.~      Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function~     parameters.~   "
136779|NCT01264653|"~     The purpose of this study is to study the safety and efficacy of intracameral adrenaline for~     pupil dilation without topical mydriatics in refractive cataract surgery.~   "
137199|NCT01259154|"~     Introduction: The aim of the study was to investigate the effectiveness of combined bipolar~     radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a~     single session for obstructive sleep apnea (OSA) and to determine whether this combination~     is safe and well tolerated.~   "
136781|NCT01264627|"~     A recent National Health Interview Survey reported that breathing exercises were the second~     most common complementary and alternative medicine practice in the United States, following~     only the use of natural products. With such widespread interest in breathing exercises,~     alone or as a component of practices such as meditation, a need exists for research that~     examines not only its efficacy, but also investigates potential mechanisms of action.~     Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM)~     Meditation Workshop recommended research to clarify biological pathways by which meditation~     practices, including breathing exercises, can impact health. To explore mechanisms~     underlying the health effects of breathing exercises, new translational tools are needed~     that can measure breathing patterns in both the clinic and natural environment. The primary~     objective of the present proposal is the application of a new technology to the~     investigation of pathways by which breathing exercises can affect health. For this project,~     the health-related outcome measure to be studied is a major cardiovascular risk factor,~     blood pressure.~   "
136782|NCT01264614|"~     This study will evaluate the effects of low-intensity strengthening exercise on the brain~     (thinking and processing speed) for patients with early dementia, compared with normative~     older adults. Participants will engage in 3 months of exercise 3-5 times per week using a~     chair and small weights. It is hypothesized that there will be a significant improvement in~     brain function.~   "
136783|NCT01264601|"~     Historically, providing influenza vaccination of egg allergic children and young adults~     (EAC) with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction~     to egg (e.g., severe hives, swelling, or asthma), has been contra-indicated, though~     vaccination of children with less severe egg allergy has been shown to be safe. Though many~     children with severe egg allergy, including anaphylaxis, have received past influenza~     vaccination anecdotally, very few data exist to show this procedure is safe. The~     investigators propose a double blind, placebo-controlled randomized, prospective~     multi-centered study to a) demonstrate seasonal trivalent influenza vaccine (TIV) can be~     safely given in a single dose (as opposed to through 2-step graded dosing of 10% then 90% of~     the vaccine dose) to EAC despite history of anaphylaxis or previous severe allergic reaction~     to egg; and b) provide further evidence that adverse outcomes are not related to ovalbumin~     (egg) content in TIV.~      Study participants must have a documented history of a severe egg allergy, substantiated by~     both a history of clinical reactivity AND either a positive skin test or ImmunoCAP/RAST test~     greater than 0.7 kUA/L. Participants will be randomized to receive either a 2-step graded~     challenge or a single dose given after a small placebo dose of saline (to mimic the graded~     challenge). If required, all participants will receive a booster vaccination as a single~     dose.~   "
136784|NCT01264588|"~     The purpose of this study is to determine whether topical application of calcium~     glycerophosphate will result in superior wound appearance and scar minimization.~   "
136785|NCT01264575|"~     This prospective randomized double-blind dose-response study is aimed to investigate the~     ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee~     replacement arthroplasty.~   "
136786|NCT01264562|"~     The study will investigate the impact of cancer-related stress and its consequences (acute~     and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in~     breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and~     the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients~     shall be evaluated.~   "
136787|NCT01264549|"~     Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome.~     Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to~     improve stroke outcome. Therefore, the investigators will evaluate whether intensified~     infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment~     improves functional outcome after stroke compared with standard therapy based on current~     guidelines.~   "
136788|NCT01264536|"~     We will test the hypothesis that bovine lactoferrin supplementation prevents serious~     infections in preterm infants. We will conduct a randomized placebo-controlled double blind~     study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units~     in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of~     late-onset sepsis.~   "
136789|NCT01264523|"~     The main objective of this study is to evaluate the effects on anthropometric, glucose~     metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index~     products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2~     diabetes patients following a chronologically scheduled pattern.~   "
136790|NCT01264510|"~     A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid,~     and a sound processor connected with the implant. The sound processor delivers bone~     conducted stimuli to the cochlea, bypassing the outer and middle ear.~      Some patients who are unable to wear or do not benefit from a conventional air-conduction~     hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or~     a mixed hearing loss. Recently however, Baha's are also being recommended in patients with~     unilateral deafness. Sound coming from the deaf side is captured and transmitted through~     bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to~     assess in those patients.~      Therefore, the goal of the current study is to examine the benefit of a Baha in patients~     with different audiological profiles (unilateral or bilateral conductive or mixed hearing~     loss, and unilateral deafness). Special attention will be given to predictive determinants~     of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling~     of patients.~   "
136791|NCT01264497|"~     The purpose of this study was to determine whether TH9507, a stabilized analogue of growth~     hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of~     diabetes in patients with type 2 diabetes.~   "
136792|NCT01264484|"~     The objective of this study is to assess long term safety and durability of the Advantage~     prosthetic heart valve.~   "
136842|NCT01263821|"~     RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor~     definition, thus may lead to better tumor targeting and avoid damaging critical parts of~     normal brain.~      PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating~     patients with newly diagnosed intracranial glioma.~   "
136843|NCT01263808|"~     This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral~     moxifloxacin.~   "
136793|NCT01264471|"~     The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War~     Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou~     Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias~     (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell~     known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the power~     plants of the body. Mitochondria take the food you eat and break the food down into a form~     of energy that the body can use. The investigators propose that Gulf War Syndrome is~     determined by a complex interaction of factors that interfere with mitochondrial function.~     This study will be the first investigation of mitochondrial function in Gulf War Syndrome.~     The investigators objective is to establish the cause for symptoms in affected veterans,~     develop testing that can more easily identify Gulf War Syndrome, and ultimately develop~     treatment protocols for Gulf War Syndrome.~   "
136794|NCT01264458|"~     The purpose of this research study is to look at how trauma affects the ability of blood to~     clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and~     this research study will look at blood drawn from people after they suffer a traumatic~     injury to see how well their blood clots.~   "
136795|NCT01264445|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an~     adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months~     1, 2, 3, and 4.~   "
136796|NCT01264432|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with radiation therapy in treating patients with advanced solid malignancies (abnormal cells~     divide without control and can invade nearby tissues) with peritoneal carcinomatosis,~     epithelial ovarian, fallopian, or primary peritoneal cancer. Veliparib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy~     uses high energy x rays to kill tumor cells. Giving veliparib with radiation therapy may~     kill more tumor cells.~   "
136797|NCT01264406|"~     This study will compare the effect of two doses of exercise on energy intake and body~     weight. The comparison will be between three groups; two exercise groups and a control~     group. The exercise groups will not be provided with a dietary intervention and the study~     design also includes a non-exercise control group. E-Mechanic trial can make important~     contributions to understanding of the role of exercise dose in weight management. While it~     is accepted that regular exercise plays an important role in general health, the exact role~     of exercise in prevention of weight gain, weight loss and prevention of weight regain~     remains poorly understood despite exercise being widely prescribed for these purposes. The~     idea that current weight management exercise recommendations may produce increased energy~     intake (or other forms on compensation) resulting in disappointing weight loss is an~     important public health issue. The finding of this study could help shape future exercise~     and weight loss recommendations and treatment plans.~   "
136798|NCT01264393|"~     Behavioral weight loss programs can successfully reduce body weight, but these programs are~     available to limited numbers of overweight and obese individuals. This project evaluates a~     unique weight loss approach that combines a self-sustaining weight loss campaign (for~     outreach) with training in behavioral weight loss strategies and strategies to increase~     accountability (to improve weight loss success). This innovative combination has the~     potential to be a cost-effective model for disseminating weight control interventions.~   "
136799|NCT01264380|"~     This randomized, open-label, two period crossover study will evaluate the effect of food on~     the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous~     administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients~     will be randomized to receive in a crossover design single oral doses of RO5185426 with or~     without food, with a 10-day washout period between doses. Following the crossover periods,~     patients will receive RO5185426 orally twice daily on a continuous basis until disease~     progression or unacceptable toxicity occurs.~   "
136800|NCT01264367|"~     A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence~     compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine~     and peg-interferon sequential treatment in patients with chronic Hepatitis B who have~     HBeAg(+)~   "
136801|NCT01264354|"~     This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir~     and clevudine combination in patients with chronic hepatitis B.~   "
136802|NCT01264341|"~     The purpose of this study is to determine whether the combination of~     bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing~     after anti-VEGF treatment~   "
136803|NCT01264328|"~     The clinical hypothesis of this study is that the first-line treatment with the combination~     of panitumumab and paclitaxel will provide benefit for patients with metastatic or current~     Squamous Cell Carcinoma of the Head and Neck (SCCHN)~   "
136804|NCT01264315|"~     Rationale: We recently reported a study where overall and event free survivals in newly~     diagnosed myeloma patients receiving an autologous transplant followed by an allograft from~     an HLA-identical sibling were superior as compared to those undergoing a double autologous~     transplant. A larger multicenter study by the Gruppo Italiano Trapianti di Midollo (GITMO),~     co-ordinated by our group and recently closed, employing a tandem auto-allo approach in~     newly diagnosed patients confirmed the achievement of prolonged event free and overall~     survival. Importantly, the achievement of at least very good partial remission at the time~     of allografting conferred a significant advantage in both event-free-survival (HR 0,23, CI~     0,11-0,48; p=0,0001) and overall survival (HR 0,26; CI 0,09-0,79; p=0,02). Moreover, recent~     advances in the understanding of the pathogenesis of multiple myeloma have identified~     specific signalling pathways that have become targets for biologically-based drugs such as~     thalidomide, bortezomib and lenalidomide and employed in several trials, including after~     allograft. The aim of the current proposal is to combine the post-transplant efficacy of~     graft-vs.-myeloma with the anti-myeloma effect of lenalidomide in newly diagnosed myeloma~     patients with an HLA-identical sibling treated with a tandem autograft-allograft approach.~     Maintenance/consolidation of the response may be a key factor to further improve rate of~     clinical and molecular (as a prelude to cure) remissions and prolong overall and event free~     survivals after allografting. We would like to investigate the safety and efficacy of~     lenalidomide as consolidation/maintenance therapy in patient undergoing tandem~     autologous-allogeneic transplant.~      Objectives of study: To evaluate 1) toxicity and tolerability of lenalidomide after~     allografting; 2)To evaluate efficacy of lenalidomide in inducing complete remission, defined~     as negative immunofixation, 12 months after allografting; 3) overall-survival; 4) event-free~     survival; 5) molecular remission rate. Furthermore we plan to compare molecular remission~     rate in patients treated with lenalidomide after tandem auto-allo transplant and after~     double autologous transplant and to monitor minimal residual disease in patients achieving~     clinical CR with lenalidomide.~      Patient Selection: Patients with newly diagnosed multiple myeloma with an HLA identical~     sibling suitable for PBSC donation will be included. Complete cytogenetic analysis at~     diagnosis will be required. The patient must have the capacity to give informed consent. Age~     >18 and < 65. Negative pregnancy test and willing to use contraceptive techniques during and~     for 12 months following treatment is required. Only very unfitted patients will be excluded.~      Treatment plan: Lenalidomide will be started at 6 months post-allotransplant at the dose of~     10 mg/day continuously in all patients (unless in molecular CR), if the following conditions~     are present:~        -  absolute neutrophil count > 1 x 109/L without the use of growth factors;~        -  platelet count > 75 x 109/L without transfusion support;~        -  calculated or measured creatinine clearance: ≥ 20 mL/minute;~        -  total bilirubin < 2 x the upper limit of normal,~        -  AST and ALT < 2.5 x upper limit of normal~        -  less than 1 mg/kg/day of prednisone, and no more than 2 immunosuppressive drugs other~          than steroid to control GVHD (if more immunosuppression is required to control GVHD,~          the maintenance therapy with lenalidomide will be held until this criteria will be~          satisfied) Treatment will be continued without interruption, unless not tolerated,~          until unacceptable adverse events are experienced or progressive disease occurs.~          Moreover, lenalidomide will be discontinued in patients who achieve and maintain~          molecular remission for 2 consecutive controls at least 6 weeks apart.~      Safety section - dose modification plan: During the study patients will be monitored for the~     occurrence of side effects. Toxicity events will be graded according to the NCI toxicity~     criteria. In case of severe toxicity, the lenalidomide dose will be reduced or withheld as~     outlined in the protocols.~      Statistical section: - Total patient sample size: 53. This is a phase 2 study designed~     according to a Simon's two-stage Minimax Design. An early stopping rule will be established~     to interrupt the study in case of futility (a non satisfactory response rate). In stage I 27~     patients will be enrolled; if < 14 complete remissions will be observed, the trial will be~     stopped. In stage II 26 more patients will be enrolled. If ≥ 32 responses will be observed,~     it will be concluded that the lenalidomide maintenance is active in increasing the complete~     remission rate after auto-allograft.~      Analysis plan: Toxicity monitoring will be incorporated into the study design by requiring~     that the trial be terminated after an initial stage if the number of observed toxicities~     (treatment related deaths) is excessive.~   "
136805|NCT01264302|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the~     reference formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fed conditions in~     healthy adult male subjects.~   "
136806|NCT01264289|"~     The objective of this study was to evaluate the relative bioavailability of the test~     formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the~     reference formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fasting conditions in~     healthy adult male subjects.~   "
136837|NCT01263886|"~     Primary Objective:~        -  To demonstrate progression free survival (PFS) improvement for ombrabulin compared to~          placebo, in combination with taxane and platinum, as first line treatment for patients~          with metastatic non-small cell lung cancer (NSCLC).~      Secondary Objective:~        -  To determine overall survival (OS), overall response rate (ORR) according to Response~          Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential~          biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite,~          RPR258063, using a population approach.~   "
136844|NCT01263782|"~     The goal of this clinical research study is to learn if knowing biomarker status can help~     researchers find better treatment combinations for patients with advanced NSCLC.~      Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab)~     to give in combination with carboplatin and pemetrexed. The safety of these drug~     combinations will also be studied.~   "
136807|NCT01264276|"~     The primary objective of this multi-center clinical study is to evaluate the validity,~     reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of~     prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet~     referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an~     ophthalmologist experienced in ROP.~      We shall:~        1. Calculate the accuracy, using sensitivity and specificity, of the system to provide~          remote evaluations when compared with the findings of a gold standard indirect~          ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously~          trained in ROP diagnostic examinations (validity);~        2. Determine intra-reader and inter-reader agreement for deciding whether digital images~          indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by~          an ophthalmologist experienced in ROP (reliability);~        3. Determine whether imaging evaluation can be achieved for each baby (feasibility);~        4. Examine ocular and systemic complications associated with digital imaging and compared~          with those associated with diagnostic examinations performed by an ophthalmologist~          (safety);~        5. Compare the costs and benefits of adopting a telemedicine retinal imaging system~          compared to the current cost of indirect ophthalmoscopic examinations~          (cost-effectiveness).~   "
136808|NCT01264263|"~     This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and~     several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean~     diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.~   "
136809|NCT01264250|"~     In this early phase study, healthy male volunteers will be randomly assigned to one dose of~     either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and~     Pharmacokinetics of AZD2927.~   "
136810|NCT01264237|"~     The present study will aim to determine the safety, efficacy, and tolerability of~     etoricoxib, an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or~     pain caused by abnormal activity of sensory neurons, remains undertreated. Post herpetic~     neuralgia (PHN), which is commonly referred to as post-shingles pain, is the most useful~     disease to study when investigating the efficacy of pain relievers for Neuropathic pain.~     Therefore, this study will primarily involve patients with PHN.~      The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.~   "
136811|NCT01264224|"~     1. Primary Objective:~             -  To evaluate safety and tolerability of single and multiple oral dosing of~               PAC-14028 in healthy male volunteers.~        2. Secondary Objective:~             -  To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral~               dosing of PAC-14028 in healthy male volunteers.~   "
136812|NCT01264211|"~     To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid~     arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.~      To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral~     MTX therapy in those patients for up to 24 weeks~      To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped~     (carry-over effect)~   "
136813|NCT01264198|"~     The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in~     patients with NAFLD.~   "
136814|NCT01264185|"~     The purpose of this study is to conduct preparatory research needed to design a behavioral~     intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in~     care and to determine whether a similar intervention structure can be used across various~     sexual risk groups and cultural settings.~   "
136815|NCT01264172|"~     This project investigate any difference in inflammatory response,wound heeling rate,~     functional outcome and level of pain in patience with different surgical treatment (PCCT vs.~     DHS vs. Osteosynthesis with nails) after a fracture of the proximal femur.~   "
136816|NCT01264159|"~     It is well known that 20-25% of patients hospitalized for acute myocardial infarction will~     develop acute heart failure during their hospitalization. Currently, the investigators have~     no reliable parameter for prediction of evolving acute heart failure in such a group of~     patients. As a result, the investigators have no way of preventing acute heart failure.~     Treatment of these patients only begins after appearance of clinical signs of acute heart~     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of~     evolving acute heart failure. This study will attempt to address whether preemptive lung~     impedence-guided therapy may prevent the development of overt acute heart failure and~     improve their clinical outcome.~   "
136817|NCT01264146|"~     This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy~     (HBOT) decreases soft-tissue complication rate during the operative handling of~     intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory~     criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify~     patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to~     determine the optimal time point for operative intervention using these microcirculatory~     criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative~     microcirculation, 4. To collect preliminary data to evaluate the economical impact of wound~     complications, with and without HBOT, 5. To identify a correlation between HBOT with~     expected limited soft-tissue complication rate and the clinical and radiographic outcome two~     years after surgery.~   "
136818|NCT01264133|"~     An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy~     or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with~     chronic hepatitis B.~   "
136838|NCT01263873|"~     The purpose of the study is to determine if there are differences related to ease of~     intubation reported by clinicians who use the Parker Flex-Tip® endotracheal~     tubes(ETT)compared to the standard Mallinckrodt® (ETT). The problem is two (ETTs), the~     Parker Flex-Tip® and the Mallinckrodt®, are currently available for use in operative suites~     for intubation, but few studies have compared these devices with each other. Two research~     questions to be answered in the study are 1. Is there a difference in the ease of intubation~     when the Parker Flex-Tip® (ETT) is used when compared to the standard Mallinckrodt® (ETT)?~     and 2. Are there differences in the number of successful intubations when comparing the~     Parker Flex-Tip® (ETT) and the standard Mallinckrodt® (ETT)? The hypotheses are the use of~     the Parker Flex-Tip® (ETT) will demonstrate: 1. Fewer seconds to intubate the trachea. 2.~     Higher self-reported ease of placement scores and 3. Fewer redirections to intubate the~     trachea. The number of successful intubations is expected to be the same in both arms of the~     study.~   "
136819|NCT01264120|"~     Obesity is a major health problem that is affecting more and more people's lives. One of the~     most successful treatments for obesity is weight loss surgery. Not all patients, however,~     lose the desired amount of weight, some regain weight and some have the surgery reversed.~     Interviews with patients and discussions with patient support groups indicate that many of~     the 'unsuccessful' patients feel unprepared for the operation and describe how although the~     surgery fixes their body it neglects their mind. They would therefore like to have more~     psychological support.~      The present study aims to set up and evaluate a health psychology led bariatric~     rehabilitation service (BRS) and determine the impact of such a service on patient outcomes~     following surgery. The BRS would offer information, support and mentoring pre and post~     surgery and address psychological issues such as dietary control, self esteem, coping and~     emotional eating. It is predicted that a bariatric rehabilitation service would primarily~     improve weight loss following surgery but would also aid changes in other aspects of the~     patient's well being.~      Obesity is a risk factor for a multitude of illnesses such as heart disease, diabetes and~     cancer. If effective, obesity surgery improves a patient's health and reduces their need for~     NHS care. If unsuccessful then the costs include not only subsequent NHS costs due to these~     other illnesses but also the costs of the unsuccessful operation and the emotional cost to~     the patient. The bariatric rehabilitation service should help to improve the effectiveness~     of surgery which in the longer term is likely to be cost effective.~      This research is a direct response to the needs identified by patients and by offering a~     more comprehensive bariatric service the success and subsequent health and well being of~     obese patients should be improved.~   "
136820|NCT01264107|"~     An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses~     With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.~   "
136821|NCT01264094|"~     The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in~     Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.~   "
136822|NCT01264081|"~     Background:~      - Studies of melanoma tumor samples have shown that tumor cells from approximately 20~     percent of melanoma patients contain a specific mutation of a gene involved in making a~     protein called ERBB4, and that changes in this gene have been associated with cancer.~     Lapatinib, a drug that is currently approved for the treatment of breast cancer, has been~     shown in the laboratory to significantly slow the growth of melanoma cells that contain this~     specific ERBB4 gene mutation. Researchers are interested in determining whether lapatinib~     can be effective against melanoma in individuals who have the ERBB4 mutation.~      Objectives:~      - To evaluate the safety and effectiveness of lapatinib as a treatment for melanoma with~     ERBB4 mutation that has not responded to standard therapy.~      Eligibility:~      - Individuals at least 18 years of age who have stage 4 melanoma that has not responded to~     standard therapy.~      Design:~        -  Participants will be screened with a full physical examination and medical history, as~          well as tests of tumor tissue taken from previous surgeries or biopsies or from a new~          biopsy that will be conducted before the start of the study. Test results to determine~          eligibility will be available within about 2 weeks.~        -  Participants will take four lapatinib tablets daily (two in the morning, 1 hour before~          or after breakfast and two in the evening, 1 hour before or after dinner) during every~          28-day cycle of treatment. Participants will keep a medication diary to record tablets~          taken and any side effects from the medication.~        -  After the first 2 weeks, and every 2 to 4 weeks afterward for the first 12 weeks,~          participants will have clinic visits with blood samples and other tests to determine if~          lapatinib is causing their disease to shrink or be controlled. If the disease has not~          progressed, participants will continue to receive a new lapatinib supply every 28 days~          for up to 2 years (27 cycles), and will continue to have regular clinic visits to~          monitor the progress of treatment.~        -  When tumor tissue is easily accessible and can be easily biopsied, researchers will~          collect two additional biopsies, one after 2 weeks of treatment and one after 12 weeks~          of treatment....~   "
136823|NCT01264068|"~     Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of~     complicated chemical constituents. Many confounding factors influence activity of Chinese~     herbs, including the origin of the herbs, safety of the products and consistency between~     batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more~     challengeable due to unresolved problems of product quality control, screen of effective~     principles, monitor of the marker constituents and the targets for site of action. In this~     project, we will introduce the concept of metabolomics to detect total metabolites spectra~     as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between~     changes in total metabolites and clinical improvements when menopausal women receive Suan~     Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive生化湯.~   "
136824|NCT01264055|"~     Background:~      - Bronchiectasis is a type of lung condition in which the lungs airways are abnormally~     stretched and widened. This stretching and widening makes it difficult for mucus and other~     substances to move out of the lungs, encouraging the growth of bacteria and leading to~     breathing problems or infection. Bronchiectasis can be caused by genetic disorders or~     diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in~     developing better ways to diagnose and treat a lung problem called idiopathic or unexplained~     bronchiectasis.~      Objectives:~      - To better describe the physical characteristics, radiographic patterns, and airway~     microbiology of unexplained bronchiectasis and to look for possible genetic links or risk~     factors.~      Eligibility:~        -  Individuals at least 18 years of age who have a chronic cough and who have had a CT~          scan that has revealed signs of bronchiectasis.~        -  Current smokers or those who have smoked for at least 10 years, as well as individuals~          who have known causes of bronchiectasis or who have had organ transplants, are not~          eligible to participate.~      Design:~        -  Participants will have one outpatient clinic visit for evaluation with a physical~          examination including detailed body size measurements and medical history and for~          collection of blood samples for routine lab tests and genetic analyses and a chest~          x-ray if no recent one is available.~        -  Participants will also have tests of lung function, and measurement of a gas called~          nitric oxide in the nose. Participants whose initial tests show abnormal results may~          also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test~          to measure salt concentrations.~        -  Participants will also have a sputum specimen collected during the visit and will be~          asked to collect two additional early morning sputum samples and a mouth rinse at home~          within 2 weeks of the clinic visit, and mail the sample collection materials to the~          research team....~   "
136825|NCT01264042|"~     Although the essential role of iron during pregnancy is well established, concerns have been~     raised that current iron supplements given routinely during pregnancy may also have harmful~     consequences, such as increased oxidative stress and enhanced risks of infection,~     pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of~     adverse effects is the appearance of non-transferrin-bound iron after oral administration of~     iron supplements. Non-transferrin-bound iron is more readily available to pathogens and~     could promote injurious free radical reactions that might add to the oxidative stress of~     pregnancy.~      The present study will determine if oral administration of 60 mg of iron as ferrous sulfate~     during the second trimester of pregnancy is followed by the appearance of~     non-transferrin-bound iron two hours later. The investigators will examine the influence of~     a variety of factors, including iron status and previous use of iron supplements. Detection~     of non-transferrin-bound iron after administration of an iron supplement to pregnant women~     would be an important new observation that could lead to re-evaluation of current methods of~     iron supplementation.~   "
136839|NCT01263860|"~     Patients with HCV genotype 6 infection who have a rapid virological response to treatment~     are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no~     important difference in effect between the two treatment effect.~   "
136840|NCT01263847|"~     The purpose of this study is to determine the effects of galactooligosaccharide (GOS)~     supplementation on calcium absorption and and gut microbe profiles.~   "
136841|NCT01263834|"~     The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on~     the result of trabeculectomy in primary term of intraocular pressure (IOP).~   "
136845|NCT01263769|"~     The goal of this clinical research study is to learn if axitinib can help to control kidney~     cancer. The safety of this drug will also be studied.~   "
136826|NCT01264029|"~     Background:~        -  New weight-loss intervention programs are being studied to determine their~          effectiveness in helping overweight and obese individuals reach a healthy weight.~          However, these programs often have not been tested against each other, and researchers~          are interested in determining which interventions are most effective both immediately~          and over the long term in promoting and maintaining weight loss.~        -  Mindful Tai Chi is a combined form of the meditative martial art tai chi and the~          practice of mindfulness meditation. Tai chi and mindfulness meditation both have common~          philosophical underpinnings that address health promotion and well-being by applying~          the skill of non-judgmental awareness on a moment-to-moment daily basis. More research~          is needed on whether Mindful Tai Chi and mindfulness meditation can help improve~          various health factors in overweight and obese individuals.~      Objectives:~      - To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a~     discussion group on the weight and well being of overweight and obese participants.~      Eligibility:~      - Healthy individuals at least 18 years of age who are either overweight or obese (body mass~     index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour~     of aerobic exercise per week within the last month), and are willing to commit to a specific~     weight-loss intervention program.~      Design:~        -  This study involves four visits for collecting information and 12 weeks of research~          study activities.~        -  During the first visit, participants will hear information about the study and may ask~          any questions. They will be screened with a medical history and physical examination,~          and those eligible will be assigned to one of the four study groups: Mindful Tai Chi~          (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group.~        -  For the second visit, participants will give blood and urine samples, receive an~          abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out~          health-related questionnaires.~        -  For 12 weeks, participants will be involved in the following activities depending on~          their group:~        -  MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each~          session will include at least 20 minutes of meditation. Participants will receive~          written instructions and an accompanying DVD in comparable formats specifying a minimum~          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a~          workshop for mindfulness skill application in daily activity.~        -  MM: Class for 2 hours per week of mindfulness meditation. Participants will receive~          written instructions and an accompanying DVD in comparable formats specifying a minimum~          of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a~          workshop for mindfulness skill application in daily activity.~        -  MW: Participants will meet at a designated mall location once a week for 2-hour walk.~        -  WD: Participants will meet at the National Institutes of Health for weekly weight-loss~          discussion.~        -  For the third and fourth visits, participants will receive the same procedures as those~          used in the second visit. These visits will occur at the end of the 12-week activity~          period and at a 3-month follow up visit.~   "
136827|NCT01264016|"~     The purpose of this study is to evaluate the performance and acceptability of a new blood~     glucose monitoring system, which includes meter and sensor strip.~   "
136828|NCT01264003|"~     Inguinal hernia repairs is clean surgical procedures. However infection may be a concern~     when prosthetic materials are used. This prospective randomized study has been set to~     observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.~   "
136829|NCT01263990|"~     Main hypothesis: there is no difference between stroke volume measurements recorded by a new~     noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as~     Picco2-system, FloTrac and transesophageal echocardiography~   "
136830|NCT01263977|"~     Septic shock and multi-organ failure are among the most frequent causes of death in the ICU.~      Patients with septic shock require early implementation of hemodynamic therapy to keep the~     duration of shock state and with it microcirculatory disturbances as short as possible. In~     the septic shock guidelines by the american association SCCM the diagnosis of volume status~     is based on filling pressures, like CVP. Some studies show, that the CVP depends not only on~     the intravascular volume, but also on the right ventricular compliance, pulmonary vascular~     resistance as well as intrathoracic pressure. The aim of the Study is to evaluate if the~     duration of septic shock can be reduced through algorithm driven volume therapy orientated~     to thermodilution based volume parameters (GEDI and ELWI)~   "
136831|NCT01263964|"~     The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in~     Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in~     acute ischemic stroke. Consecutive patients with acute ischemic stroke admitted to the~     Department of Neurology Campus Benjamin Franklin of the university hospital Charité will be~     screened for cTnT elevations suggestive of myocardial infarction (>0,05 µg/l). Patients with~     increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic~     findings of coronary angiographies taken out in age- and gender-matched patients presenting~     with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will~     serve as a control. The primary endpoint of the study will be the occurrence of culprit~     lesions indicating focal cardiac damage on the basis of an acute CAD.~   "
136832|NCT01263951|"~     The goal of this study is to determine the effect of combining everolimus and sorafenib in~     patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.~   "
136833|NCT01263938|"~     Activated monocytes play a key role in the pathogenesis of HIV-associated neurocognitive~     disorders (HAND). Individuals with HAND have expanded populations of activated monocytes.~     These monocytes are thought to emigrate into the CNS, where they produce neurotoxic~     proinflammatory factors, and also carry virus into the CNS. Statins are cholesterol lowering~     drugs with pleiotropic immunomodulatory / anti-inflammatory properties that are currently~     being explored for immunomodulation of T cell activation in several diseases, in addition to~     their established role to treat hyperlipidemia and atherosclerosis. The investigators in~     vitro data suggests that these drugs can downregulate monocyte activation patterns seen in~     HIV infection. No in vivo studies have yet been carried out to assess the effects of statins~     on the pro-inflammatory monocyte population in chronic HIV disease. This will be a pilot~     study of whether statin treatment will reduce the inflammatory monocyte phenotype and~     downregulate the inflammatory cytokines that have been linked to neuropathogenesis in HIV~     infection. If so, they may have potential as adjunctive therapy in HIV-associated~     neurological disease. The investigators propose to:~        -  Determine the effect of Atorvastatin on peripheral blood monocyte populations in a~          12-week pilot study in chronically HIV-infected people on HAART therapy.~        -  Determine the relationship between changes in monocyte phenotype following Atorvastatin~          treatment, and soluble markers of activation/inflammation linked to neuropathogenesis,~          as well as activation status of T cells.~   "
136834|NCT01263925|"~     Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with~     Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the~     pain-free walking distance in patients with Intermittent Claudication.~   "
136835|NCT01263912|"~     This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13~     months of age. The study will use a classic nutrition design to assess if infants' feeding~     practices in Canada place infants 1-2 years of age at risk for low long chain~     polyunsaturated fatty acid (LCPUFA), nutrients known to influence growth, and brain and~     immune system development. On enrollment, infants will be assigned at random to a nutrition~     supplement providing omega 6 and omega 3 LCPUFA or a PUFA placebo.~   "
136836|NCT01263899|"~     This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with~     advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent~     Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small~     lymphocytic lymphoma).~   "
136846|NCT01263756|"~     The proposed pilot study will begin to assess whether driving impairments are included in~     the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be~     completed by obtaining data on velocity, collision risk, and visual attention of subjects~     with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period~     (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5~     hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive)~     who have been identified as having an ASD from a prior diagnosis or participation in~     community conferences for individuals with ASDs.~   "
136847|NCT01263743|"~     Interventions such as Relaxation Response appear to have widespread effects on physiology.~     Endothelial function, changes in genomic expression, several biomarkers have been associated~     with chronic stress and cardiovascular dysfunction, and there is some suggestion that~     elicitation of the Relaxation Response may lead to improvement in-or normalization of-these~     factors. By studying the impact of the Relaxation Response on endothelial function, genomic~     expression and biomarkers among subjects with hypertension, it may be possible to better~     understand the biologic underpinnings of Relaxation Response-type interventions.~     Furthermore, with a greater understanding of the physiologic mechanisms by which the~     Relaxation Response works, it may be possible to better target other symptoms and conditions~     that can be effectively treated by such an intervention.~   "
136848|NCT01263730|"~     The goal of this research is to evaluate whether Tai Chi merits further investigation as a~     non-pharmacological therapy in the treatment of Major Depressive Disorder (MDD).~     Specifically, this waitlist-controlled study will gather preliminary data evaluating the~     effectiveness of Tai Chi training as treatment for patients with MDD or a history of MDD,~     including patients who continue to be depressed despite taking antidepressants and patients~     who choose not to take antidepressants due to fear of side effects and/or for personal~     reasons. To test this hypothesis the investigators will compare physical and psychological~     parameters of a control group and an intervention group, at baseline (Week 0), at the~     midpoint (Week 6), and at the end of 12 weeks of Tai Chi training.~   "
136849|NCT01263717|"~     HIV-infection and its treatment are often associated with an increase in belly fat, as well~     as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and~     increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may~     contribute independently to increased belly fat and to increased cardiovascular risk through~     effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth~     hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients~     with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat~     accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not~     yet known. The current study is designed to determine the effects of tesamorelin treatment~     on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and~     markers of cardiovascular health including blood vessel thickness (carotid intima media~     thickness [cIMT]) and markers of inflammation in the body. The investigators hypothesize~     that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease~     markers of inflammation, with either neutral or beneficial effects on glucose metabolism.~   "
136850|NCT01263704|"~     This single arm, open-label study will assess the safety and efficacy of low dose~     fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan~     (rituximab) as primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic~     leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375~     mg/m2 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine~     (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles~     1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.~   "
136851|NCT01263691|"~     The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and~     immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and~     female subjects between 18 and 50 years of age will receive vaccinations via the~     intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via~     laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant~     medications, and local and systemic signs and symptoms of reactogenicity.~   "
136852|NCT01263678|"~     Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches.~     For most people, the decision depends on how bothered they are by their symptoms and how~     they feel about having surgery. Since individuals with the same clinical presentation may~     feel differently about their symptoms and how they view the benefits and harms of their~     options, there is no agreed upon besttreatment. It has been shown that, for~     preference-sensitive decisions like this one, decision aids (tools that pair balanced,~     evidence-based information regarding treatment options with values clarification) improve~     patients'knowledge and realistic expectations, lower decisional conflict, increase patient~     involvement in decision making, decrease the number of undecided, and increase agreement~     between values and choice.1 The Spine Center, in collaboration with the Center for Shared~     Decision Making (CSDM) at Dartmouth Hitchcock Medical Center (DHMC), has been providing~     patients with decision aids (DAs) for several years.~      Hypothesis:~      Patients identified as having low literacy and/or high decisional conflict after viewing a~     video decision aid will show greater resolution of their decisional conflict, higher~     decision self-efficacy and less decision regret if a coaching intervention is paired with a~     video decision aid.~      Decision support in the form of coaching develops patients'skills in preparing for a~     consultation and deliberating about their options.2 A study of women with abnormal uterine~     bleeding showed that pairing coaching with a DA helped patients clarify their values and~     preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to~     assess the impact of coaching in patients with lumbar spinal stenosis who are referred to~     the CSDM for a video decision aid about their treatment options. The investigators are also~     interested to learn whether screening for low literacy and high decisional conflict can~     identify a subgroup of patients who are more likely to benefit from coaching.~   "
136853|NCT01263665|"~     The purpose of this study is to confirm the safety and performance of the 25 cm GORE®~     VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral~     Artery.~   "
136854|NCT01263652|"~     The investigators will conduct a randomized double blind study, to determine whether patient~     analgesic delivery mode preference affects pain reduction quality in non-surgical spine~     patients.~      The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo.~     During the study period, pain reduction parameters will be collected. At the end of the~     study period, the investigators will attempt to find a correlation between pre-study patient~     preferences and the quality of the pain reduction achieved.~   "
136877|NCT01263353|"~     The purpose of this study is to assess the safety and tolerability of pasireotide LAR in~     combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary~     neuroendocrine Tumors (NET).~   "
136855|NCT01263639|"~     Objectives: Patient satisfaction is a key determinant of the quality of care and an~     important component of pay for performance metrics. The purpose of this study was to~     evaluate the impact of a simple intervention aimed to increase patients' understanding of~     their orthopaedic trauma surgeon and improve patient satisfaction with the overall quality~     of inpatient care delivered by the attending surgeon.~      Design: Prospective quality improvement initiative using a randomized intervention.~      Setting: Level 1 academic trauma center.~      Patients/Participants: Two hundred twelve patients were eligible; 100 patients were~     randomized to the intervention group, and 112 patients were randomized to the control group.~     Overall, 76 patients could be reached for follow-up satisfaction survey, including 34~     patients in the intervention group and 42 patients in the control group.~      Intervention: Patients randomized to the intervention group received an attending biosketch~     card, which included a picture of the attending orthopaedic surgeon with a brief synopsis of~     his educational background, specialty, surgical interests, and research interests.~      Main Outcome Measures: Our primary outcome measure was a patient satisfaction survey~     assessing patients' rating of the overall quality of inpatient care delivered by the~     attending surgeon.~   "
136856|NCT01263626|"~     The aim of the study is to establish the accuracy of a new device designed specifically to~     record and detect cough episodes.~      Cough is an important defense mechanism of the respiratory tract. The presence of chronic~     cough may indicate the presence of underlying diseases, including reflux. Despite the~     increased number of patients suffering from cough in the ENT and GI practice, to date, there~     has been no method/device to objectively assess the frequency of cough episodes in a given~     patient.~      PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an~     innovative device that is able to record cough episodes and then automatically detect and~     count them with the help of a specific software program. This study will assess the accuracy~     of this novel cough monitoring and counting technology and validate potential clinical use~     in patients with chronic cough.~   "
136857|NCT01263613|"~     The purpose of this study is to determine if the investigators are able to locate and~     measure certain characteristics in breast cancer tumors that have been treated with~     paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.~   "
136858|NCT01263600|"~     The purpose of this study is to describe participants 6 months to <18 years of age with~     hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and~     Canada and identify predictors of disease activation and progression.~   "
136859|NCT01263587|"~     The primary purpose of this study is to describe participants with hepatitis B virus (HBV)~     infection and identify factors that may cause the disease to activate or worsen.~   "
136860|NCT01263574|"~     This study is designed to determine if the use of 70% ethanol lock solution in central lines~     decreases the rate of central line infections in children with short bowel syndrome. While~     ethanol locks have been used safely in children, there has been no published research to~     date that clearly shows it is of definite benefit in this group of patients.~   "
136861|NCT01263561|"~     Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome:~     IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from~     baseline without medication or additional glaucoma surgery and qualified success defined as~     IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication~     but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications,~     visual acuity, number of complications, corneal pachymetry and corneal endothelial cell~     counts.~   "
136862|NCT01263548|"~     ADHD in the adult population is associated with several measures of harmful dysfunction. For~     example, adult ADHD is associated with high rates of separation/divorce and never-married~     status, lower educational attainment and occupational achievement, absenteeism,~     presenteeism, and job termination, as well as decreased social function. Individuals with~     adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder,~     alcohol and substance abuse, as well as antisocial personality disorder.~      Psychostimulants are the most frequently employed medications in the treatment of adult~     ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of~     ADHD symptoms in adulthood.~      Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the~     treatment of ADHD symptomatology in adult individuals with bipolar disorder.~      Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)~     ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,~     lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and~     active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a~     longer duration of effect consistent throughout the day with reduced potential for risk of~     abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other~     psychostimulant medications. Available evidence indicates that in most treated subjects,~     Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some~     individuals, it is associated with improvement in both glucose and lipid homeostasis.~      The evaluation of safety/tolerability profiles as well as the effectiveness of~     lisdexamfetamine in a real-world population has significant translational value.~   "
136863|NCT01263535|"~     This clinical trial is designed to investigate the performance of SENSIMED Triggerfish®~     during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid~     recording intervals over the 24-hour period.~      The investigation will recruit male and female patients older than 18 years and diagnosed~     with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the~     study. Patients will be considered enrolled in the study upon signature of informed consent.~     A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour~     hospitalisation, are planned for each patient.~   "
136878|NCT01263340|"~     The investigators will describe the characteristics, prevalence, incidence, severity~     co-morbidity and management of patients with chronic obstructive pulmonary disease (COPD) in~     the UK. 100 practices will be sampled amounting to a total study population of about 10 000~     patients. Information will be collected electronically and, where necessary, by a hand~     search of patient records.~   "
136879|NCT01263327|"~     This phase I clinical study was designed to evaluate the safety of novel recombinant HPV~     16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women~     18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV~     vaccine administered intramuscularly according to a 0-1-6 month schedule.~   "
136864|NCT01263522|"~     Health-promoting effects of physical exercise are well-investigated especially for endurance~     activities. However, for different individuals, positive effects have different sizes, even~     non-responders are observed. Other forms of training, such as strength training and interval~     training, are less well investigated. Therefore, a comparative longitudinal training study~     is warranted to examine differences of preventive effects (outcome measures: ergometric~     descriptors of physical performance, established risk factors and prognostic factors for~     cardiovascular diseases) of continuous endurance training, interval training and strength~     endurance training.~      In a second stage, the observed non-responders will perform a different type of training~     (cross-over). It is expected, that besides a comparative general efficacy evaluation of the~     three training types, improved recommendations for optimized individualization of training~     parameters can be formulated.~   "
136865|NCT01263509|"~     The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin~     and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for~     40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add~     on study.~   "
136866|NCT01263496|"~     The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once~     daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40~     consecutive weeks in participants who completed a phase 2 dose-ranging study.~   "
136867|NCT01263483|"~     The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily~     (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2~     diabetic patients with uncontrolled blood glucose.~   "
136868|NCT01263470|"~     The purpose of this study was to evaluate the dose-response relationships of alogliptin,~     once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the~     optimal clinical dose for type 2 diabetic patients.~   "
136869|NCT01263457|"~     This is a National, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for~     growth hormone treatment from hospital in the UK and to assess the level of adherence of~     subject receiving SAIZEN® via Easypod™.~   "
136870|NCT01263444|"~     The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a~     single agent to prostaglandin monotherapy in patients with either ocular hypertension or~     primary open-angle glaucoma.~   "
136871|NCT01263431|"~     Aim of the study is to compare short term results of 2 surgical treatment for grade 3~     hemorrhoidal disease, namely: pain and postoperative morbidity,complications and~     effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction~   "
136872|NCT01263418|"~     This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular~     lymphoma or marginal zone lymphoma and participants will be age 70 or older.~      The purpose of this research study is to learn about the safety of the treatment with the~     drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma.~     Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some~     types of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can~     bind substances in the body including cancer cells. Ofatumumab binds to the protein called~     CD20, which is found on B-cells and lymphoma cells.~      The study drug, Ofatumumab, is approved by the United States Food and Drug Administration~     (FDA) for treatment of other types of blood cancer and is not approved for use in patients~     with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered~     investigational.~      In addition to learning about ofatumumab, the researchers are interested in learning about~     how this cancer treatment affects daily activities. Participants will be asked to complete a~     Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional~     status, mental health, and level of social support. This assessment will help the health~     care team understand a participant's functional age as compared to a participant's actual~     age.~      The researchers also want to collect blood samples to study molecules in follicular lymphoma~     cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker~     is a molecule (for example, DNA or protein) found in the blood or tissues that is a marker~     for disease. In this study, the investigators will measure the changes of the biomarker~     called bcl-2. This biomarker research will only be in subjects with follicular lymphoma.~   "
136873|NCT01263405|"~     The purpose of this study is to determine the ability of a specific imaging method, termed~     Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which~     can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in~     patients with sarcomas. Sarcoma patients face comparatively poor response rates to~     chemotherapy and early, non-invasive indications of response could provide physicians with~     the information necessary to make evidence-based changes in treatment strategies. Patients~     who do not demonstrate early signs of response would be spared the unnecessary side-effects~     of an ineffective chemotherapy regimen, and could either be switched to a different regimen~     or undergo surgery~   "
136874|NCT01263392|"~     The primary aim of this study was to determine if using the SpeediCath hydrophilic catheter~     would reduce the incidence of symptomatic urinary tract infections (UTI)in children with~     spina bifida who perform clean intermittent catheterization for bladder management. The~     hypothesis was that the incidence of symptomatic urinary tract infections would be~     significantly reduced (by 25%) in users of the SpeediCath hydrophilic catheter when compared~     to users of a reused polyvinyl chloride (PVC) catheter. Subjects were randomly assigned to~     either starting the study with PVC catheter for 6 months followed by the hydrophilic~     catheter for 6 months or visa versa. Each subject kept a weekly diary recording urinary~     tract infections symptoms, hematuria determined by urine dipstick, physician visits, days of~     missed school and other activities. At the end of each 6 months subjects completed a~     questionnaire recording their comfort and satisfaction in using the PVC or hydrophilic~     coated catheter. 70 subjects were randomized and 46 had complete data. There were no~     differences in febrile UTI, antibiotic use, healthcare visits or school days missed. The~     incidence of self reported UTI was lower in the PVC group than the hydrophilic group. 40% of~     subjects indicated that the hydrophilic coated catheter was slippery and difficult to handle~     compared to 10% for the PVC catheter. However overall satisfaction was no different between~     products. The study results are consistent with the current Cochrane Review that there is a~     lack of evidence to state that the incidence of UTI is affected by multiuse or hydrophilic~     catheter use.~   "
136875|NCT01263379|"~     This trial will create a skin graft, which the investigators call LEAES, using the~     patient's own skin cells that have been genetically engineered in the lab to express a~     missing protein called type VII collagen. The corrected cells will be transplanted back to~     the patient.~   "
136876|NCT01263366|"~     This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate~     the safety of topical norepinephrine in post-surgical breast cancer patients who are~     undergoing radiation therapy.~      The study will also provide information about whether topical norepinephrine can prevent or~     decrease the severity of the radiation dermatitis experienced by these patients.~   "
136880|NCT01263314|"~     This is a randomized, double-blind, placebo-controlled study. Two panels, each consisting of~     eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8~     elderly females with mild to moderate hypertension in Panel B) will be randomized to receive~     either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of~     MK-8266 or matching placebo in three treatment periods (Periods 1 through 3). In both Panel~     A and Panel B, doses will escalate in a rising, fixed sequence. In Period 1 (0.3 mg), Period~     2 (0.6 mg), and Period 3 (1.0 mg) once daily doses of MK-8266 or matching placebo will be~     administered. Blood samples will be obtained pre-dose and at selected time points up to 48~     hours post-dose for determination of MK-8266 plasma concentrations.~   "
136881|NCT01263301|"~     Subclavian steal phenomenon is normally observed in patients with stenosis of subclavian~     artery proximal to orifice of vertebral artery(V0). However, uremic patients undergoing~     hemodialysis using vascular access in the arm or forearm may also develop dialysis~     associated steal syndrome(DASS).For patients with symptomatic subclavian steal phenomenon,~     the treatment for these two groups is different. The investigators want to see if the~     investigators can use noninvasive duplex examination instead of invasive conventional~     angiography to do the differential diagnosis.~   "
136882|NCT01263288|"~     The primary aim of the present trial is to study the effect of daily vitamin D~     supplementation on muscular power and force among non-western immigrants living in Oslo,~     Norway, and secondarily to study the effect of musculoskeletal pain and headache.~      The investigators have also prespecified a number of additional research questions about~     anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney~     function, which because of multiple comparisons should be interpreted with caution unless~     the statistical evidence for an effect is very strong.~   "
136883|NCT01263275|"~     Among antidepressant treatments, ECT stands as the most effective in treating acute~     depression. However, patient concerns with the cognitive side effects of ECT have encouraged~     the development of new and more focal forms of brain stimulation such as transcranial Direct~     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the~     way that it is currently administered and this has raised interest in finding alternative,~     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS~     stimulation using an alternative electrode montage has antidepressant effects.~   "
136884|NCT01263262|"~     Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the~     chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on~     the face prior to cutaneous surgery decrease the chances of a post-operative wound~     infection?~   "
136885|NCT01263249|"~     To determine if the way local anesthetic, or numbing medication, is delivered through a tiny~     tube next to the nerves that go to the thigh affects the strength and sensation in the~     thigh.~   "
136886|NCT01263236|"~     The purpose of this study is to investigate the safety and tolerability of ascending single~     and multiple oral doses of LY2940094 in healthy male subjects.~   "
136887|NCT01263223|"~     The purpose of this study is to determine the effect of LY2216684 on heart rate and blood~     pressure in research participants with MDD who are being treated with an SSRI (selective~     serotonin reuptake inhibitors). Information about any side effects that may occur will also~     be collected. The duration of participation in this study is approximately 24 days not~     including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights~     and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the~     start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18~     mg LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four~     single daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.~   "
136888|NCT01263210|"~     Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of~     the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small~     reduction in the number of AOM episodes has been noted in unselected child cohorts after~     vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in~     order to investigate whether vaccination could reduce the number of AOM episodes in very~     young, otitis-prone children.~   "
136889|NCT01263197|"~     The purpose of this study is to determine the effect of LY2216684 on heart rate of healthy~     people receiving Albuterol and Propranolol. Information about any side effects that may~     occur will also be collected.~   "
136890|NCT01263184|"~     The studies object is to evaluate the degeneration of overhead sports in wheelchair-using~     athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain~     compared to non disabled athletes.~   "
136891|NCT01263171|"~     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.~     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor~     cells that remain after surgery.~      PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil~     together, before and after radiation therapy and surgery in treating patients with rectal~     cancer that can be removed by surgery.~   "
136907|NCT01262963|"~     The study is a Phase 1, open-label study designed to characterize the absorption,~     distribution, metabolism and excretion of GSK2118436 following administration of a single~     oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive~     tumors.~   "
136929|NCT01262677|"~     Approximately 30% percent of subjects with partial seizures are refractory to treatment with~     single or combination antiepileptic drugs. The present study will compare the efficacy of~     two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as~     adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy,~     using a randomized, parallel group design.~   "
136930|NCT01262664|"~     The goal of this clinical research study is to find the highest tolerable dose of~     PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there~     are no standard therapy options. The safety of this drug will also be studied.~   "
137200|NCT01259141|"~     Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming~     more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.~   "
136892|NCT01263158|"~     Slow labour progress is common in nulliparous women and is associated with childbirth~     complications and negative birth experiences. Oxytocin augmentation is widely used to treat~     slow labour despite associated risks for the fetus. An ongoing debate concerns whether~     oxytocin should be administered directly or postponed after arrested labour. The overall aim~     is to study labour progress in healthy nulliparous women and to compare childbirth outcomes~     and experiences in women randomised to expectant versus early oxytocin augmentation for slow~     labour progress.~      The hypothesis is that it is to early to start oxytocin treatment when labour progress has~     been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial~     for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised~     controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active~     labor at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery~     ward were included (n=2,072). All women whose labour did not progress after amniotomy~     (n=630) were randomly allocated either to labour augmentation by oxytocin infusion (Early~     oxytocin, n=314) or to postponement of oxytocin augmentation for another three hours~     (Expectant, n=316). One month postpartum the women received a postal questionnaire~     concerning their experiences of labour and birth. All participating women gave their~     informed consent. Maternal and neonatal outcomes like mode of delivery, postpartum~     haemorrhage, perinatal lacerations, low Apgar score, need of neonatal intensive care and~     maternal experiences of childbirth were compared between the randomised groups.~   "
136893|NCT01263145|"~     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 (MK2206)~     when given together with paclitaxel and to see how well they work in treating patients with~     solid tumors that have spread to other places in the body and usually cannot be cured or~     controlled with treatment or breast cancer that has spread to other places in the body. Akt~     inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving Akt inhibitor MK2206 and paclitaxel may be a~     better treatment for solid tumors or breast cancer.~   "
136894|NCT01263132|"~     This is a prospective, randomized, double blind, comparative, experimental controlled Phase~     3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin~     combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in~     subjects with chronic distal diabetic polyneuropathy.~   "
136895|NCT01263119|"~     The purpose of this study is to determine how warfarin might affect LY2216684 and how giving~     LY2216684 might affect warfarin in the body. Information about any side effects that may~     occur will also be collected.~   "
136896|NCT01263106|"~     The primary aim of this study is to confirm that LY2216684 is not an inhibitor of CYP1A2 in~     vivo using theophylline as a probe substrate for the enzyme. Since LY2216684 has been~     observed to increase heart rate in some healthy subjects, this study will also assess heart~     rate when co-administered with theophylline.~   "
136897|NCT01263093|"~     The purpose of this study is to measure how much of the study drugs reach the blood stream~     and how long it takes the body to get rid of them, and determine how clopidogrel and~     LY2216684 might affect each other in the body. Information about any side effects that may~     occur will also be collected.~   "
136898|NCT01263080|"~     Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating~     the effects of adding mirtazapine and folic acid to existing therapy for patients with~     schizophrenia~   "
136899|NCT01263067|"~     The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces~     posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma~   "
136900|NCT01263054|"~     The primary objective of this randomized controlled trial is to evaluate the safety and~     efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine~     using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual~     Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will~     be compared against medical management (standard of care).~   "
136901|NCT01263041|"~     effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates~     via its role as a NO precursor. Also, enteral glutamine which may play a role as an~     immunomodulator on preterm neonates. all these had never been studied in developing~     countries where sepsis and nec act as a major participant in mortality rates.~   "
136902|NCT01263028|"~     Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D~     deficiency in the Chronic Kidney Disease population requiring recombinant human~     erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of~     erythropoietin required to maintain a nonanemic state.~   "
136903|NCT01263015|"~     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50~     mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil~     fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48~     weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1~     infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and~     development of viral resistance will be evaluated.~   "
136904|NCT01263002|"~     An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and~     Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B~     Associated Hepatocellular Carcinoma~   "
136905|NCT01262989|"~     It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,~     02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions~     receive, in each period, the test formulation or the reference formulation~   "
136906|NCT01262976|"~     The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline~     (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human~     Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis~     endemic region.~      Subjects will be followed-up for 3 years.~      Subjects will be enrolled in 3 cohorts:~        -  HIV-positive adults on highly active antiretroviral therapy~        -  HIV-positive adults not on highly active antiretroviral therapy~        -  HIV-negative adults~      Each cohort will have 2 groups.~   "
137201|NCT01259128|"~     The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75~     years or older nocturic patients.~   "
136908|NCT01262950|"~     The investigators plan to conduct a first-stage experiment by recruiting ten subjects,~     including five PD patients and five non-PD patients. In the beginning, the information~     collected by the portable motion detector is used to compare the difference in the~     activities performed by PD and non-PD patients. Besides, the algorithm will be developed to~     identify the gait patterns of PD patients. Once the system detects the abnormal gaits, such~     as shuffling and festinating steps or freezing of gait, auditory cues will be given to the~     PD patients and caregivers by their sides. It can help the patient to maintain normal gait~     and improve the effectiveness of rehabilitation, as well as preventing falls in daily~     activities. Moreover, in case of accident falls, the real-time fall detection mechanism~     alerts the nearest caregiver for instant support and delivers this information to the remote~     family members and medical personnel.~      After that, a second-stage experiment will be carried out by recruiting another five PD~     patients. By comparing the gait patterns identified by the system against those identified~     manually by the staff, the performance of the proposed system on fall prevention will be~     examined. For the patients and their family members, the developed system enhances the~     patients' safety in their daily activities. As for the medical personnel, it serves as an~     affordable tool that benefits the rehabilitation of PD patients in an easy manner.~   "
136909|NCT01262937|"~     The goal of the project is to determine whether confocal endomicroscopy can be used to~     identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as~     compared with histologic specimens as a reference. The project will evaluate those at risk~     for or with known Barrett's esophagus, and those with known or suspected biliary strictures.~     It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic~     tissue.~   "
136910|NCT01262924|"~     The purpose of this study is to assess the immunogenicity and reactogenicity of~     GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals)~     reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content~     diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™~   "
136911|NCT01262911|"~     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit~     systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice.~     The objective of this study is to test if SRT2379 may be a novel compound for the treatment~     of inflammatory disorders in man.~   "
136912|NCT01262898|"~     GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and~     MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up~     to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater~     prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory~     findings. Pharmacokinetic parameters were linear and approximately dose proportional over~     the range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly~     increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable~     isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed~     throughout repeated dosing to healthy volunteers for 14-days.~      The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects~     (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040~     after 28 days of once-daily dosing in Type I and Type II diabetic subjects with~     gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic~     effect relationship.~   "
136913|NCT01262885|"~     GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole~     hydrochloride) is a Gram negative antibacterial compound currently in development for the~     treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae,~     and Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses~     being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg,~     b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized,~     placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety,~     tolerability and pharmacokinetics of oral GSK2251052.~   "
136914|NCT01262872|"~     This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of~     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and~     co-administered with other routine paediatric vaccines in infants in The Gambia. Two~     formulations containing different doses of pneumococcal antigen and two different schedules~     will be tested in infants.~   "
136915|NCT01262859|"~     Induction chemotherapy is gaining momentum in the management of locally advanced squamous~     cell carcinoma of the head and neck (SCCHN). The combination of docetaxel, cisplatin, and~     5-FU (TPF) was superior compared with PF in a Phase III clinical trials73,74. We have~     completed a Phase II clinical trial that showed that docetaxel, cisplatin, and cetuximab~     (TPE) is highly active and well tolerated as induction chemotherapy in SCCHN (Argiris et al.~     ASCO 2008; A6002). Preliminary survival results are very encouraging. 39 patients were~     enrolled and with median follow up 26 months the 2-year PFS was 70% and the 2-year OS~     84%.The combination of chemotherapy plus cetuximab is already a standard treatment in~     recurrent or metastatic SCCHN47. Therefore, TPE can be used as the platform for the addition~     of novel agents.~      EGFR and VEGF are among the most important and validated molecular targets in cancer~     therapy. The incorporation of novel targeted therapies to chemotherapy and radiotherapy is~     of particular interest in head and neck cancer, and may improve efficacy without~     significantly increasing toxicity. A Phase III trial of carboplatin/paclitaxel/bevacizumab~     with or without cetuximab in advanced NSCLC has been proposed by SWOG. Bevacizumab is~     currently being investigated in SCCHN with promising results. A Phase II study investigating~     the combination of pemetrexed and bevacizumab (UPCI 05-002) as well as a Phase II trial of~     cetuximab and bevacizumab (UPCI 05-087) in recurrent or metastatic SCCHN are ongoing at the~     University of Pittsburgh with encouraging results (ASCO 2008 and ASCO 2009). In this study,~     32 have been already enrolled. There was only 1 patient with grade 3 hemorrhage. The~     objective response rate is 20%, the median PFS 2.8 months and the median OS 8.1 months.~      In order to further improve the efficacy of TPE and the rate of complete responses we~     propose to add bevacizumab to the TPE followed by XPE regimen we developed at the University~     of Pittsburgh. Due to non-overlapping toxicities and based on our prior experience we~     anticipate that the regimen will be well tolerated. Moreover, we plan to obtain tumor~     biopsies and blood samples in the first cycle and evaluate the modulation of biomarkers post~     combination therapy. Data from induction with TPE (presented at ASCO 2009) indicate the~     potential significance of cytokine levels in patient outcome. Also, we will evaluate the~     feasibility of subsequent concurrent radiation, cisplatin, cetuximab and bevacizumab.~     Patients with stable disease in the primary could be considered candidates to surgical~     resection at the discretion of their physician, if the tumor is resectable.~   "
136916|NCT01262846|"~     The overall goal of this study is to compare the safety and immunogenicity of trivalent~     Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.~     Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used~     vaccine~   "
136931|NCT01262651|"~     This 9-week study will aim to determine the efficacy, safety and tolerability of Sativex®~     (Nabiximols) as an adjunctive treatment, compared with placebo in relieving uncontrolled~     persistent chronic pain in patients with advanced cancer.~      Eligible patients will not be required to stop any of their current treatments or~     medications.~   "
136917|NCT01262833|"~     The study will address the role of internal pudendal artery disease in erectile dysfunction~     (ED), and whether it might eventually be amenable to intervention with stenting. There is~     currently a small trial investigating the potential benefit of stenting for erectile~     dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction~     is not yet proven. The investigators intend to perform angiography on patients both with and~     without erectile dysfunction, to see whether internal pudendal artery disease is more common~     in the population with erectile dysfunction. In addition to angiography, stenoses will be~     examined using fractional flow reserve. The degree of internal pudendal artery disease will~     then be correlated with the degree of erectile dysfunction using a validated questionnaire,~     the International Index of Erectile Function (IIEF). Patients will then complete IIEF~     questionnaires for 5 years to assess the relationship between internal pudendal artery~     disease and progression of erectile dysfunction.~   "
136918|NCT01262820|"~     This is an open label Phase II Trial that using the investigational anti-cancer agent,~     Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by~     decreasing the size of the tumor or stopping its growth.~   "
136919|NCT01262807|"~     This a randomized controlled study to test the hypothesis that patients who perform in-cast~     exercises will have superior range of motion immediately post-cast removal, without a~     concomitant increase in complication rate when compared with a control group who receives~     standard post cast care which does not include the intervention exercises.~   "
136920|NCT01262794|"~     To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc)~     administration of CDP6038 to Japanese subjects.~      To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of~     CDP6038 to Japanese subjects~   "
136921|NCT01262781|"~     The obesity epidemic has reached down into the infant and toddler age group. Dietary~     indiscretion during pregnancy, particularly in our current food environment, is a major risk~     factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is~     itself a risk factor for obesity and metabolic syndrome in the offspring, possibly even~     during childhood. Temporal increases in fructose consumption in the last two decades~     coincide with temporal increases weight gain during pregnancy and with increased birth~     weight, including a higher prevalence of macrosomic newborns. Our central hypothesis is that~     higher fructose consumption during pregnancy is a risk factor for infant obesity and~     metabolic syndrome.~   "
136922|NCT01262768|"~     Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food~     servings. The objectives of this study are to determine (a) if food portion size estimation~     accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion~     Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in~     the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of~     overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will~     be more accurate in food portion size estimation and will be more satisfied with the tool~     compared to the group that receives the 2D PSMAs.~   "
136923|NCT01262755|"~     DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in~     minority populations. Specific objectives of this K24 research project are to: (1) Provide~     an estimate of the prevalence of gastroesophageal reflux disease in an urban, African~     American population; (2) Determine whether specific risk factors including diet, tobacco~     use, physical activity, and psychosocial stress are important in the targeted population. We~     will also measure height, weight, and waist/hip circumference to determine the impact of~     central obesity on reflux. PUBLIC HEALTH RELEVANCE: This research will help doctors to~     understand the frequency and risks for esophageal reflux disease (heartburn) in African~     Americans.~   "
136924|NCT01262742|"~     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most commonly uterotonic drug used to prevent and treat PPH in North America, however, there~     are some limitations to its use. Oxytocin has a very short duration of action, which~     requires a continuous infusion to achieve sustained uterotonic activity. The Society of~     Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg~     dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent~     post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin~     lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent~     greater efficacy rate. However, a dose response to determine the minimum effective dose of~     carbetocin has not yet been published.~      We hypothesize that a dose-response study will establish the minimum dose of carbetocin~     required to produce appropriate contractility in 95% of the women (ED95) undergoing elective~     cesarean delivery.~   "
136925|NCT01262729|"~     In this clinical trial will be checked, whether 2 hour ventilation with xenon has~     neuroprotective effects in patients with out of hospital cardiac arrest and successful~     cardiopulmonary resuscitation~   "
136926|NCT01262716|"~     This study will assess safety and ergonomics/engineering design of a novel cancer treatment,~     Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on~     primary and metastatic tumors involving the skin, in particular to improve the~     functionality, efficiency and wearability of the light delivery device (LDD) as well as the~     overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study~     (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st~     generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for~     subjects with chest wall recurrences of breast cancer.~      A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm~     (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible~     with the laser, delivering light to a designated region on the patient's skin.~   "
136927|NCT01262703|"~     To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native~     coronary arteries.~   "
136928|NCT01262690|"~     This study will examine whether a single dose of PF-05230901 is safe and well tolerated when~     given to healthy volunteers by injection under the skin. An additional objective is to~     measure the blood concentrations of PF-05230901. Each dose will be tested in a different~     group of subjects starting from the lowest dose.~   "
136932|NCT01262638|"~     This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of~     ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.~   "
136933|NCT01262625|"~     This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic~     imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission~     tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major~     adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related~     death, and cross-over to revascularization. CCTA may be used to direct patients with~     symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of~     CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or~     revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional~     insights into alternate explanations of chest pain, and increased cost-effectiveness in~     comparison with use of SPECT MPI/invasive coronary angiography (ICA).~   "
136934|NCT01262612|"~     In some patients with cancer there are also cancer cells in the abdominal cavity or between~     the lung membranes. These cancer cells create too much moisture in the abdominal cavity or~     between the lung membranes. If there is fluid in the abdominal cavity (ascites fluid) this~     can bring on abdominal distension, abdominal pain, loss of appetite, fatigue, bloating and~     sometimes wheezing. Too much fluid between the lung membranes (we call this pleural fluid)~     gives breathlessness, chest pain and coughing. The use of diuretics may offer a small group~     of patients symptom reduction. Additionally, the fluid can be drained through a needle~     puncture or fluid collection (through a biopsy). But usually, the moisture quickly returns.~      Previous research done in this hospital with cediranib showed that with some patients with~     cancer who suffered from fluid in the abdominal cavity or between the lung membranes, this~     moisture reduces while using this drug. It also reduced the symptoms caused by this~     excessive moisture.~      The current study is conducted to see whether patients with cancer and fluid in the~     abdominal cavity or fluid between the lung blades benefit from using cediranib. This~     involves not only whether the amount moisture reduces, but also if the complains decrease.~     In addition, we will carefully consider the possible side effects of cediranib.~   "
136935|NCT01262599|"~     Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common~     post-mastectomy breast reconstructive surgeries that utilize the patient's tissue. The~     pedicled TRAM flap involves harvesting skin, fat, and muscle from the abdomen to create a~     new breast. TRAM flap complications include fat necrosis of the reconstructed breast,~     delayed wound healing, and abdominal bulge or hernia. Pain at the abdominal donor site is a~     major contributor to the need for four to five days of post-operative hospital stay. Pulsed~     electromagnetic field (PEMF) technologies have been useful as adjunctive therapy for the~     treatment of delayed union fractures, chronic wounds and post-operative pain. PEMF devices~     are economical and disposable, and can be incorporated unobtrusively in standard~     post-operative dressings. The investigators have recently reported, in a double-blind,~     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a~     significant decrease in pain and pain medication use, along with a concomitant decrease in~     IL1-beta in the wound bed.~      The proposed study seeks to determine whether similar results will be obtained after a~     significantly more extensive surgical procedure, like the TRAM flap. Patients scheduled for~     pedicled TRAM flap breast reconstruction of a single breast immediately following mastectomy~     will be enrolled in this double-blind, placebo-controlled, randomized study. Subjects will~     be assigned to one of two groups: a treatment group with active PEMF devices and a placebo~     group with sham devices that deliver no PEMF. PEMF and sham devices will be taped over both~     the breast reconstruction and abdominal donor sites. Patients will keep the devices in place~     for their hospital stay and for a total of two weeks. The investigators hypothesize that~     subjects in the PEMF treatment group compared to placebo will have a faster reduction in~     pain, take less pain and nausea medications, have lower levels of IL1-beta in wound exudate,~     have a shorter hospital stay, and have less wound-healing complications.~   "
136936|NCT01262586|"~     This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles~     between vildagliptin and glimepiride.~   "
136937|NCT01262573|"~     This study compares outcomes among patients having a total laparoscopic hysterectomy. This~     involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top~     of the vagina is routinely sutured closed after this procedure and this study is comparing~     two different suture materials for this purpose. One suture material is a barbed suture that~     has the advantage of maintaining good tension and closure on the wound. The other is a~     standard smooth suture that is commonly used for this procedure. The investigators are~     comparing the time it takes to close the vaginal cuff, as well as bleeding after surgery and~     the healing of the top of the vagina.~   "
136938|NCT01262560|"~     RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by~     chemotherapy and radiation therapy. It is not yet known whether Manuka honey is more~     effective than standard care in preventing pain.~      PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it~     works in preventing esophagitis-related pain in patients receiving chemotherapy and~     radiation therapy for lung cancer.~   "
136939|NCT01262547|"~     This study evaluates micrografting using a harvesting and grafting process that has been~     designed by Momelan Technologies. The overall concept is to harvest several small pieces of~     skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a~     commercially available suction blister device, adhere them to a sterile elastomeric~     substrate and is then place it on a recipient area prepared by epidermal dermabrasion~     (removal of the epidermis).~   "
136940|NCT01262534|"~     The purpose of this study is to assess the clinical profile of patients with moderate to~     severe psoriasis in Spain. The primary objective is to analyze the clinical profile of~     patients with moderate to severe psoriasis, as defined by a set of conditions (obesity,~     hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease,~     etc.) and its correlation to the patients' quality of life. The secondary objectives are to~     describe the demographic characteristics and habits of the patient, to evaluate the clinical~     characteristics of the disease, and to describe the diagnostic and therapeutic procedures~     being used in standard clinical practice and the patients' expectations for these therapies.~   "
136941|NCT01262521|"~     An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most~     notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion~     (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are~     particularly intriguing since nitrate and nitrite are abundant in our everyday diet.~      Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate~     offers a novel mechanistic approach to regulate mobilization of circulating angiogenic cells~     and thus regenerative processes in cardiovascular medicine is not known. Thus, in the~     present study, we tested whether oral application of nitrate leads to an enhanced number of~     circulating angiogenic cells and whether this is associated with an improvement in~     endothelial function.~   "
137202|NCT01259115|"~     The purpose of this study is to assess the pharmacokinetics of buprenorphine and its~     metabolites in the presence and absence of ketoconazole.~   "
136942|NCT01262508|"~     Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice~     unexpected deterioration of cardiovascular function remains a serious problem and an~     important cause of death. Novel perspectives in reflex testing of the autonomic nervous~     system might be useful to protect some patients from cardiovascular events by detecting~     cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings~     is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is~     evidence that additional analyses of pulse wave characteristics might be a valuable source~     of information to generate additional insights into the cardiorespiratory status of the~     patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients~     from cardiovascular events in consequence of hemodynamic instability in the future.~   "
136943|NCT01261520|"~     This study examined whether a culturally-tailored video has a greater impact on increasing~     mammography use in Chinese American women and improving barriers to mammography screening~     compared to a generic, non-tailored video and a printed fact sheet (control group).~   "
136944|NCT01261507|"~     A new software product takes two chest radiographs, aligns them, and then subtracts one~     image from the other. The resulting image represents an image showing any differences~     between them. The study is to determine whether radiologists using this new software perform~     better with it than when they do not use it.~   "
136945|NCT01261494|"~     This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with~     GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.~      And to assess the tolerability and safety of once-a-day administrations of oral doses of~     GFT505 for 12 weeks in patients with type 2 diabetes mellitus.~   "
136946|NCT01262495|"~     we will use testicular tissue from patient who underwent orchidectomy due to medical reasons~     and test the viability of the tissue after cryopreservation and de-freezing.~   "
136947|NCT01262482|"~     In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the~     6th in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th~     amongst men. The average of 5-year survival rate in Spain is under 30%. The main reason of~     it is that, despite carrying out an adjuvant treatment, more than the 50% will present~     relapsed disease.~      Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant~     V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as~     VEGFR 2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell~     renal carcinoma.~      The mechanism by which Sorafenib seems to act is not because of the existence of a mutation~     of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF~     overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway.~      The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric~     carcinoma tumorigenesis and progression. Because of that, it seems interesting to associate~     Sorafenib to an oxaliplatin-based chemotherapy, which has shown its effectiveness in~     relapsed patients after receiving cisplatin-based schemes. Moreover, there is a phase 1~     trial confirming the tolerance of the oxaliplatin and Sorafenib association, describing~     partial responses amongst gastric cancer patients previously treated with cisplatin.~   "
136948|NCT01262469|"~     GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the~     combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer~     over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy~     in combination with trastuzumab.~      Due to the minimal participation of older people in clinical trials, there is a lack of data~     to make evidence-based decisions regarding chemotherapy in this indication.~      The study is designed to investigate whether elderly patients with locally advanced or~     metastatic breast cancer over-expressing HER2 could take advantage of the combination~     lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no~     detrimental impact on functional status (part of geriatric assessment).~      The main objective is to assess clinical benefit (defined at 4 months as complete response,~     partial response or stable disease), safety and preserved geriatric independence (main~     objective is a bi-criteria or composite criteria).~   "
136949|NCT01262456|"~     The purpose of this trial was to confirm/establish long-term safety and efficacy of~     desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further~     evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.~   "
136950|NCT01262443|"~     The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial~     flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual~     success of the procedure.~   "
136951|NCT01262430|"~     The OtisMed Custom-fit system for total knee replacements replaces conventional surgical~     techniques for templating and intra-operative instrumentation with a preoperative virtual~     surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT~     image. The 3D model of the affected knee is processed with a proprietary algorithm that~     virtually alters it to its pre-arthritic state by filling articular defects, removing~     osteophytes, and approximating the joint surface. The software then shape matches the knee~     replacement femoral and tibial components to the preathritic knee model and aligns the~     femoral component to the functional flexion-extension axis of the femur. The final~     preoperative step is the machining of custom biocompatible plastic cutting blocks that fit~     the arthritic knee. These cutting blocks are used during the knee replacement surgery to~     guide the bone cuts so that the replacement components are aligned for the individual~     patient.~      In this study we propose to compare patients who have received total knee replacement~     components with the OtisMed Custom-fit procedure to those who have had the same components~     implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary~     outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery.~     Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone~     mineral density, full leg alignment, change in intra-operative frontal plane alignment,~     intra-operative deviations from the surgical plan, surgery duration, OR turnover time,~     number of instrument pans used, and length of hospital stay.~   "
136964|NCT01262261|"~     Probuphine (buprenorphine implant) is an investigational implant placed just below the skin~     containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is~     a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of~     Probuphine in patients who have previously completed the 6-month PRO-806 study with either~     Probuphine, placebo or sublingual buprenorphine.~   "
136952|NCT01262417|"~     The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for~     the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer~     requiring two-stage surgery for the resection of hepatic metastases.~      Eligible patients will be randomly assigned to one of 2 arms:~        -  Seprafilm group (receiving resorbable barrier membrane during the first surgery)~        -  No-treatment control group (without seprafilm barrier during the first surgery)~      The primary objective is to establish, in patients with colorectal cancer requiring~     two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable~     barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the~     second operation.~      This study is a prospective multicentric phase II, controlled, randomized and non~     comparative trial.~      A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be~     assigned to the no-treatment control group. The inclusion period should be approximately 18~     months. The follow up period after the second surgery will be 3 years.~   "
136953|NCT01262404|"~     Three groups of subjects are trained to practice mindfulness meditation, compassion~     meditation, or attend a health training control class. Individuals from each group will~     undergo structural and functional brain imaging before and after training. The hypothesis is~     that the compassion meditation group will show the largest changes in brain structure and~     function. In a second series of experiments, the subjects practicing a Tibetan meditation~     practice will be undergo MRI thermometry imaging to construct detailed three dimensional~     temperature maps of their bodies before, during, and after they perform this practice.~   "
136954|NCT01262391|"~     This single-dose study will investigate how well solifenacin suspension is taken up, how~     long it stays in the body and how well it will be tolerated in children and adolescents aged~     5-17 years with symptoms of overactive bladder.~   "
136955|NCT01262378|"~     Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery~     using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or~     body lift (Lockwood)~   "
136956|NCT01262365|"~     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the~     treatment of subjects with Systemic Lupus Erythematosus (SLE)~   "
136957|NCT01262352|"~     The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance~     index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the~     G551D-CFTR mutation on at least 1 allele.~   "
136958|NCT01262339|"~     Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting~     approximately 3% of the population in the United States. Not only that it is a major social~     embarrassment to affected individuals, it also has significant negative impacts on career,~     school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from~     Clostridium bacteria, was approved by the U.S. Food & Drug Administration in 2004 for the~     treatment of severe focal axillary hyperhidrosis that does not respond to topical~     antiperspirants. It is becoming a promising treatment for many patients suffering this~     condition. Over the past decade, the medication has also been used effectively for many~     other forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin.~     Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are~     often limited by pain and post treatment muscle weakness associated with the procedure.~     Recent studies have demonstrated that BTX-A can be delivered across the skin via electric~     current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or~     Phoresor IIPM700). Studies with limited number of patients have demonstrated promising~     results with this new treatment.~   "
136959|NCT01262326|"~     All subjects will be evaluated by the Research Nurse at the Clinical Translational Research~     Center (CTRC) Outpatient Clinic to obtain informed consent, a brief medical history, weight,~     body mass index, waist/hip circumference and vital signs. Additionally, blood will be drawn~     at this visit to screen for renal dysfunction (Chem 10), liver disease (liver function tests~     (LFT's)), thyroid dysfunction (TSH), diabetes mellitus (HbA1C), and chronic inflammatory~     states (erythrocyte sedimentation rate). Subjects recruited to the study will be placed on a~     low-carbohydrate diet (<20 g/d without caloric restriction) designed either to promote~     weight loss or maintain weight stability for fourteen days prior to the protocol or they~     will consume a typical Western diet designed either to promote weight loss (restricted by~     1300 kcal/d in the final fourteen days) or maintain weight stability for twenty-one days.~     Subjects recruited to the study will be lean, overweight, or obese and also may carry a~     diagnosis of NAFLD. Target accrual for total enrollment for this project will be set to 80~     subjects to accommodate attrition and screen failures. The details of the low-carbohydrate~     diet have been discussed in consultation with Linda Brinkley, nutrition staff of the CTRC.~     Subjects chosen to undergo carbohydrate-restriction will have a teaching session with a CTRC~     dietician. Subjects will then initiate dietary carbohydrate-restriction on their own and~     keep a daily dietary record for seven days. At the end of seven days, the dietary record~     will be analyzed. The CTRC will then prepare all meals for the final seven days of the diet~     in accordance with daily caloric intake calculated from the dietary record.~     Calorie-restricted participants will keep a dietary record for one week while eating a~     typical Western diet. The dietician will analyze this record and meals restricted by 1300~     kcal/d will be prepared by the CTRC for the final fourteen days of the diet. Alternatively,~     some subjects eating a typical Western diet may consume prepared meals with a fixed~     content of carbohydrate, fat, and protein that is unrelated to their pre-study dietary~     intake. In this scenario, the dietary carbohydrate content may be varied between 30 and 60%~     to provide information on differences in hepatic metabolism under conditions of differing,~     but clinically sustainable, carbohydrate intake. All participants will be admitted to the~     CTRC the night prior to the study and begin an overnight fast after dinner. Between 18:00~     and 09:00, subjects will receive two stable isotope tracers orally: [U-13C]propionate at~     08:00 (three 400 mg doses given over 1 hour) and 70% 2H2O at 22:00, 02:00, and 06:00. During~     the study subjects will also be given 0.5% 2H2O ad libitum. Two 500 mg acetaminophen tablets~     will also be given at 08:00. Between 08:00 and 09:00 subjects will undergo measurement of~     their respiratory quotient (RQ) using the CTRC indirect calorimeter (Delta Trac II)..~     Subjects will then have an intravenous catheter placed and an infusion of tracer amounts of~     [3,4-13C2]glucose, [1,2-13C]β-hydroxybutyrate and [3,4-13C]acetoacetate will be initiated.~     At 1 ½ and 2 hours after initiation of the infusion, a 50 cc blood draw will be performed.~     Voided urine will be collected every hour after ingestion of acetaminophen until the~     protocol concludes. The subject will then be given a meal and discharged from the CTRC,~     marking the completion of the protocol. The collected blood and urine will be transported by~     the research coordinator to the Advanced Imaging Research Center lab for analysis by MRS.~     Another blood draw (approximately 10 cc) will be done in conjunction with the final MRI in~     order to measure changes in the lipid profile after the diet intervention. The visits in~     their entirety will be as follows:~      1 screening visit: 20 minutes~        1. dietician visit: 20 minutes~        2. MRS visits: 45 minutes each~      1 (optional) overnight visit: 20 hours~   "
136960|NCT01262313|"~     There remain important barriers to the translation of the programs like the Diabetes~     Prevention Program to public health. There is a lack of established lifestyle intervention~     programs as they are resource and time intensive, exceeding both the resources and the~     training of most primary care providers. A solution may be the implementation of lifestyle~     intervention programs in the community setting that are unrelated to primary medical care. A~     community based program at a public facility may extend the reach of lifestyle intervention~     to those unable to obtain these services from an established medical facility. Community~     lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a~     promising strategy for weight management and the reduction of risk for metabolic disease. In~     this validation study we will assess pre and post intervention to identify whether~     measurable changes can be detected in body weight, body composition, markers of metabolic~     disease and quality of life after participation in the Healthy Creations, a community~     based lifestyle intervention program presented by Center Court Fitness Center of the Grand~     Forks Park District and Altru Health System.~   "
136961|NCT01262300|"~     This is an ancillary study to a randomized controlled trial of high dose vitamin D in older~     long-term care residents (NCT01102374). In this study, a subset of trial subjects will~     receive the zoster vaccine and we will determine the immunological response to the vaccine~     in this older, frail population, as well as the association between vitamin D and~     immunological outcomes.~   "
136962|NCT01262287|"~     The purpose of this study is to evaluate whether dutasteride is safe and effective for~     reducing alcohol use in male drinkers who want to stop or reduce their drinking. The~     investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated~     and that, compared to placebo treatment, dutasteride will result in a greater reduction in~     the amount of alcohol consumed per week. The study sample size is of a pilot scale and is~     designed to provide additional support for the study hypothesis and provide an estimate of~     likely effect sizes in order to design a more definitive study.~   "
136963|NCT01262274|"~     The Aim of this study is to validate a treatment of anastrozole in combination with~     tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although~     pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has~     limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent~     administration of low-dose cytotoxic agents, is not only target tumor cells but also~     inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to~     metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole~     (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for~     postmenopausal breast cancer will be conducted.~   "
137203|NCT01259102|"~     The purpose of this study is to determine the pharmacokinetics of BTDS following same-site~     patch reapplication after rest intervals.~   "
136965|NCT01262248|"~     Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for~     the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the~     present study is to develop and evaluate a computer-based method for automated~     classification of small colorectal polyps on the basis of vascularization features.In a~     prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI~     colonoscopy. These polyps were imaged and subsequently removed for histological analysis.~     the polyp images were analyzed by a computer algorithm. The proposed computer-based method~     consists of several steps: preprocessing, vessel segmentation, feature extraction and~     classification. The results of the automatic classification (sensitivity, specificity,~     negative predictive value, positive predictive value and accuracy)were compared to those of~     human observers, who were blinded to the histological gold standard.~   "
136966|NCT01262235|"~     This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at~     multiple clinical centers. The study is designed to determine the safety, tolerability and~     PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to~     standard therapy or for whom there is no standard therapy. After the determination of the~     maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with~     refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.~   "
136967|NCT01262222|"~     The purpose of this study is to look at a new method for finding out if patients have a risk~     of heart complications from surgery. At the present, to find out if patients have a risk of~     heart complications from surgery, look at whether the patient has heart disease, diabetes,~     kidney problems, and stroke. The investigators hope that this study will confirm a new, safe~     test to help us predict the risk of surgery.~   "
136968|NCT01262209|"~     Our team is interested in what can be done to improve the functioning of patients who suffer~     from glaucoma, a chronic and irreversible eye disease. Patients with vision loss as a result~     of this disease may feel like they have been 'given up on', or lost to our medical system~     when no further interventions can be offered to treat their eye disease. It is our intent to~     investigate what alternatives we can provide our patients, instead of simply saying,~     'nothing more can be done'. We have learned from studies done on other chronic eye diseases,~     like age related macular degeneration, that low vision rehabilitation can improve visual~     function.~      What exactly is low vision? It can involve a loss of visual acuity, making activities such~     as reading or writing a challenge; it can involve loss of contrast sensitivity, making~     shapes and edges hard to discern, like those of a stair edge, or person's face. It could~     also involve a loss of peripheral, or side vision which is a symptom common to most glaucoma~     patients. Whatever the cause of low vision, doing day-to-day activities can become~     increasingly difficult, and many suffer from a loss of their independence and may even~     become depressed. Low vision rehabilitation involves helping patients to use their remaining~     vision in optimal, and sometimes even new, ways. This involves an assessment of a person's~     baseline vision, and an idea of what their needs are. Patients are then given low vision~     aids (such as magnifiers, telescopes, video screens which magnify images, and other tools)~     as well as instructions and support for adapting to living and functioning with altered~     vision.~      Although there currently exists no cure for glaucoma, and we are certainly not promising a~     reversal of the damage done to the eyes from this chronic disease, we do believe that these~     types of rehabilitation services may offer some hope and potential visual benefit to~     patients living with vision loss. Our hypothesis is that the use of state-of-the-art low~     vision aids in patients with advanced glaucomatous visual loss will provide an improvement~     in visual tasks and thereby an improvement in quality of life.~   "
136969|NCT01262196|"~     MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to~     enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a~     pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation~     characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will~     evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic~     acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse~     the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby~     prevent and reduce the duration of organ failure and improve outcome in these patients.~   "
136970|NCT01262183|"~     For esophageal cancer that can not be removed by surgery, the choice of treatment is a~     combination of chemotherapy and radiotherapy. We call this combination- (or concurrent)~     chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both~     chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The~     goal of treatment with chemotherapy and radiation therapy is to cure the cancer.~     Unfortunately only a small proportion of patients are cured with this treatment.~      Improvements in the outcome of treatment may be expected by using the so-called targeted~     treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is~     a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to~     grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that~     possibly the growth and spread of esophageal cancer is prevented.~      The main objective of this trial is to see if survival of patients with inoperable~     esophageal cancer improves as panitumumab is added to standard treatment with~     chemoradiotherapy.~      It will also investigate whether patients tolerate the addition of panitumumab to the~     standard treatment. Also, the biological characteristics of the tumor will be examined. In a~     proportion of patients it will be determined how the enhancement of the cancer is visible on~     an FDG-PET scan before the start of treatment and how this changes during the treatment. It~     will be also be evaluated how this treatment affects the survival.~   "
136971|NCT01262170|"~     A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety~     and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily~     reducing the desire to smoke~   "
136972|NCT01262157|"~     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth~     of new blood vessels. The investigators hypothesized that LISW therapy could improve the~     symptoms of patients with erectile dysfunction resulting from a problem of blood supply that~     do not respond to oral therapy (PDE-5 inhibitors).~   "
136973|NCT01262144|"~     Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease~     is identified are not usually eligible for surgery. PET-CT is used to support staging.~     However, some patients received surgery after staging and subsequently require~     radio/chemotherapy due to findings on operation.~      This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent~     outcomes i.e. need for adjuvant therapy.~   "
136974|NCT01262131|"~     The purpose of this study is to see if a device called the Resonator can help to reduce pain~     and improve aspects of health and quality of life for people with fibromyalgia.~   "
136975|NCT01262118|"~     The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol~     metabolism in patients with active rheumatoid arthritis (RA).~   "
136977|NCT01262092|"~     This study involves inducting treatment seeking opioid dependent participants onto~     buprenorphine. Once the participant reaches a stable dose they will receive either placebo~     or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the~     participant undergoes a 10-day buprenorphine detoxification.~   "
136978|NCT01262079|"~     This is a specimen collection protocol designed with the purpose of understanding the immune~     responses to influenza in children and adult subjects through collection of blood specimens~     and influenza medical history data. This protocol will allow the investigators to evaluate~     influenza-specific immune responses to a variety of influenza strains in a broad age range~     of the U.S. population early and late in the 2010-2011 influenza season. Immune responses~     will be evaluated using blood samples. The underlying hypothesis for this protocol is that~     the detailed characterization of immune responses to influenza in subjects from different~     age groups will further the understanding of immune responses cross-reactivity and advance~     development of influenza vaccines that are cross-reactive against old, new and re-emerging~     influenza strains.~   "
136979|NCT01262066|"~     A number of psychosocial risk factors have been strongly related to a range of health~     problems (chief among them CVD). Clinical research has shown that behavioral interventions~     have enormous promise to ameliorate the psychosocial distress, the health-damaging effects~     and the costs associated with these risk factors. However, few such programs have been~     implemented in a large-scale way. Corporations are increasingly interested in providing such~     services for their employees, but they have encountered difficulties in knowing which~     programs are most effective. Until these programs are developed as products that can be~     tested and shown to produce consistent benefits, dissemination of these beneficial programs~     will be hindered. Taken together, these findings make a strong case that the development of~     a standardized, protocol-driven behavioral intervention package that can be delivered in a~     wide range of corporate settings presents a remarkable commercial opportunity. The overall~     goal of this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that~     documents the effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session~     workshop) in reducing BP, psychosocial risk factors, and promoting positive health outcomes~     in a cost effective manner in a corporate setting. This empirical support, tested in a~     setting independent of the program developers and by an experienced research team, will then~     be used to help market the product in the corporate wellness marketplace. It is hypothesized~     that participants (employees in an urban medical center) in the LifeSkills intervention will~     experience greater reductions in blood pressure and improvements in measures of psychosocial~     well-being than those receiving usual medical care and given educational materials on~     reducing BP.~   "
136980|NCT01262053|"~     With the increased adoption of CPOE systems, it is important to recognize that design flaws~     have resulted in the creation of new types of iatrogenic medical errors. An example of a new~     type of iatrogenic medical error introduced by CPOE systems has been named juxtaposition~     errors. Juxtaposition errors, as defined by Ash, et al. are errors that can result when~     something is close to something else on the screen, and the wrong option is too easily~     clicked in error. Juxtaposition errors can lead to a patient receiving a medication, a~     test, or a treatment intended for another patient, sometimes with dire consequences.~     Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors~     that have multiple etiologies.~      The primary objectives of this research proposal is to investigate the prevalence of~     wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to~     investigate and compare the efficacy and workflow impact of two distinct interventions to~     prevent these errors.~   "
136981|NCT01262040|"~     The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier~     for a surgeon to see cancer.~      NBI is a kind of light. Normally, white light is used during surgery. White light uses many~     wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This~     makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels~     than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors.~      In this study the surgeon will look with both normal white light and NBI. This way a~     comparison can be made to determine which is superior.~      Improved identification of tumors allows doctors and patients to make informed decisions~     about whether treatment is needed after surgery. It also provides additional information to~     determine which treatments may be best.~   "
136982|NCT01262027|"~     The goal of this clinical research study is to learn if dovitinib can help to control~     inflammatory breast cancer. The safety of this drug will also be studied.~   "
136983|NCT01262014|"~     Given the low Responses Rates and short survival times achieved with conventional cytotoxic~     agents in resistant ovarian cancer patients, new treatment options are needed in this~     patient population.Antiangiogenic therapy has an important role in this group of patients~     and Pazopanib in particular. We are going to study if Pazopanib is able to control~     disease-related symptoms minimizing the side effects of treatment. This aspect is very~     important in the treatment of resistant ovarian cancer patient since our treatment is~     palliative without any impact in overall survival. So our goal is to study the Clinical~     Benefit Rate (objective responses plus stable disease rates) achieved with Pazopanib and its~     toxicity profile in this subgroup of patients~   "
136984|NCT01262001|"~     To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary~     Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.~   "
136985|NCT01261988|"~     The primary objective of the study is to assess the safety and adhesive performance of the~     VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by~     healthy volunteers.~   "
136986|NCT01261975|"~     The objective of this study is to test the hypothesis that the time to reach a stable~     refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision~     compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision~     Enhancement System.~   "
137006|NCT01261715|"~     Two of the more frequently used options for skin closure following a cesarean delivery~     include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin~     adhesive. This method of closure is used less frequently than either staples or sutures.~      Few studies have been done regarding whether Dermabond is preferable or affect the outcome~     of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better~     result for the closure of cesarean section wounds.~   "
136987|NCT01261962|"~     In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment:~     a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral~     zinc supplementation on humoral immunity and neutrophil function. The study will be~     conducted on 30 adult patients aged grater than 18 years, of both genders who have undergone~     surgical resection of colonic neoplastic lesions without metastatic lesion. Patients will be~     randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for~     16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also~     include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n =~     15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study~     groups will start two days before the volunteers received the pneumococcal vaccine,~     polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as~     pre-established criteria by the Oncology Service. Will be monitored the parameters of~     nutritional status (anthropometry, bioelectrical impedance, food intake, and laboratory~     tests) adverse effects, according to rules of the CTCAE. In the evaluation of humoral~     immunity, antibodies opsonization and in the pneumococcal polysaccharide will be measured.~     Will be evaluated the function of neutrophils by measuring DNA NETs and quantified~     calprotectin and elastase released in the culture supernatants of activated neutrophils.~     RT-qPCR will be done of genes differentially expressed(DEGS) on activated leukocytes. In six~     volunteers from each group will be analyzed global gene expression from RNA extracted from~     leukocytes by microarray; will be detected and correlated the molecular pathways modulated~     by zinc by MetaCore software (GeneGo). The DEGS will be validated by RT-qPCR.~   "
136988|NCT01261949|"~     Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by~     hearing loss and leading to the phantom auditory perception of sound in the absence of an~     external or internal acoustic stimulus.~   "
136989|NCT01261936|"~     Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a~     subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have~     been proposed to define this symptom: 60 on each cycle has also been confirmed in our~     preliminary study on 87 healthy women. The quantitative determination of menstrual blood~     losses is nevertheless rarely performed, only in research settings. Although menorrhagia is~     a quite frequent symptom in healthy women apparently haemostatically competent in the~     fertile age (20-30%), its incidence becomes very high in women affected by congenital~     coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's~     Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom menorrhagia has~     an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.~      This explains the need for a study focused on the evaluation of menorrhagia in CBDs,~     addressed to answer to the following, still unsolved questions:~        1. Definition of the entity of menstrual blood losses in women affected by CBDs~        2. Elaboration of specific treatment schedules for each type of CBD~        3. Impact of different specific treatment schedules on kinetic and entity of menstrual~          losses (how does treatment modify losses?).~   "
136990|NCT01261923|"~     This study aims to investigate whether liver patients may tolerate alitretinoin by comparing~     metabolism in 8 such patients with the metabolism in 8 healthy controls~   "
136991|NCT01261910|"~     The primary purpose of this study is to test different methods by which kidney transplant~     centers can educate potential transplant candidates about living donor kidney transplant~     (LDKT).~      The most effective ways to educate kidney transplant candidates about LDKT remain unclear.~     The goal is to determine, among a diverse cohort of potential kidney transplant candidates,~     whether a transplant center-based intervention will increase understanding of the~     opportunities for and process, risks, and benefits of living kidney donation and LDKT. The~     investigators hypothesize that kidney transplant candidates' understanding of living kidney~     donation and LDKT will be increased by interventions implemented at the transplant center on~     the day of transplant evaluation.~      The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to~     compare the effects of two educational strategies upon transplant candidates' understanding~     of living kidney donation and LDKT:~        1. Usual transplant education implemented by the transplant center, on the day of the~          transplant evaluation (standard care); and~        2. Intensive initial transplant education implemented on the day of the transplant~          evaluation.~      Intensive initial transplant education will utilize videos of living donors' experiences as~     well as a session with a trained Transplant Educator, who will focus upon living donation~     education. One week after the transplant evaluation day and 3 months later, the~     investigators will assess transplant candidates' knowledge of LDKT (using questionnaires),~     identify correlates of increased understanding of LDKT, and assess racial/ethnic differences~     in the understanding of LDKT.~   "
136992|NCT01261897|"~     The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and~     morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor~     -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total~     knee arthroplasty.~   "
136993|NCT01261884|"~     Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of~     both maternal and fetal complications of pregnancy. To date, there is no known cure for~     preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and~     high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure,~     and may be easier to perform in a pregnant population, leading to higher compliance. The~     investigators propose to perform a novel prospective study of a resistance training regimen~     on blood pressure in pregnant patients at high risk for developing preeclampsia or high~     blood pressure.~   "
136994|NCT01261871|"~     The purpose of this study is to measure pressures within the eye (during surgery to remove~     the prostate or abdominopelvic masses) as the body position required for these laparoscopic~     procedures has been associated with increases in pressure within the eye.~   "
137014|NCT01261611|"~     The purpose of this study is to evaluate how well a new drug called Dysport RU works and how~     safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be~     compared to an approved drug called Dysport.~   "
137248|NCT01258517|"~     The purpose of this study is to assess changes in cerebral oxygenation during two different~     types (beractant and poractant) and two different routes (double lumen or single lumen~     endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).~   "
136995|NCT01261858|"~     Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG)~     in patients undergoing surgery for coronary artery disease. Given the increasing risk~     profile of contemporary cardiac surgery patients, sternal complications are subject to~     increase concomitantly. Despite advances in many areas of cardiac surgical procedures,~     innovation in sternal closure technique has been lacking and postoperative complications~     remain. In this study, the investigators aim to assess the effectiveness of using a novel~     osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an~     adjunct to conventional sternal closure in post CABG patients having median sternotomy.~      The outcomes of interest for this study will include: pain, discomfort, lung function, wound~     healing and analgesic use. The investigators assume that the use of KryptoniteTM will~     decrease postoperative pain leading to improvement in postoperative lung function. This may~     also lead to improvement in patient recovery and decrease in postoperative complications.~      The investigators will undertake a single-blinded randomized, controlled study consisting of~     patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to~     either Group A (usual closure with stainless steel wires) or Group B (usual closure with~     stainless steel wires plus application of bone cement). Each group will consist of 64~     patients in a total of 128 patients. Lung function data using a spirometer will be collected~     preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data~     will be collected on the 1st to 5th postoperative days.~   "
136996|NCT01261845|"~     BACKGROUND: A proper understanding of the attitudes towards its own health status and~     concise estimates concerning the health seeking behavior of the different subgroups of a~     population are highly desirable. The structure of the Austrian population with regard to its~     age distribution and the proportion of people with immigrant backgrounds have been rapidly~     changing in recent years. Questions of allocating limited resources and meeting the needs of~     under-served populations have become increasingly important. However, data that could~     illuminate these issues are sparse and therefore obtaining them will be important for making~     sensible policy decisions.~      METHODS: A telephone survey of the Austrian population for the assessment of the occurrence~     of any health complaint and the subsequent help seeking behavior with special emphasize on~     under-served minority groups - migrant population, elder people, and female gender.~      AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented~     aspects and should provide the evidence for building a better health care infrastructure~     with equality of access and efficient coordination. We also hope that this information can~     help to allocate resources strategically according to needs and cost-efficiency in health~     care.~   "
136997|NCT01261832|"~     Current antiplatelet therapy in acute coronary syndrome have a focus on the dual~     antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug~     resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis.~     Therefore, recently, clinical research about the triple antiplatelet therapy including~     cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy~     for acute myocardial infarction is inadequate situation, and the ideal duration of triple~     antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical~     outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing~     percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy~     and investigate ideal duration of triple antiplatelet therapy through this research.~   "
136998|NCT01261819|"~     The study aimed to compare the use of a transurethral laparoscope to the use of a~     traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic~     hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be~     done safely using a transurethral laparoscope, takes less time than traditional cystoscopy,~     and is more cost effective than traditional cystoscopy.~   "
136999|NCT01261806|"~     Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating~     behavior and biology, and are at risk for a host of mental health problems. Critical issues~     for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers~     in foster care face significant challenges in forming new attachment relationships and~     developing behavioral and biological regulatory capabilities. This project will assess the~     effectiveness of an intervention that targets these issues. Attachment and Biobehavioral~     Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide~     nurturing care so that children develop secure, trusting relationships; and supporting~     children when they become overwhelmed that enhance children's ability to regulate behavior~     and biology. This intervention's effectiveness will be assessed in a randomized clinical~     trial.~   "
137000|NCT01261793|"~     The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the~     treatment of subjects with Systemic Lupus Erythematosus (SLE).~   "
137001|NCT01261780|"~     Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer~     therapy with few treatment options. CIPN is a complex side effect that varies between~     individuals and can be difficult to describe, difficult to treat and can significantly~     effect quality of life for patients.~      The purpose of this study is to determine if patients with painful CIPN will have a decrease~     in pain scores after treatment with the MC-5A device.~   "
137002|NCT01261767|"~     This trial is conducted in the United States of America (USA). The aim of this clinical~     trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and~     to determine the preliminary efficacy in an expansion phase of this trial.~      This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a~     multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22~     weeks.~      Initiation of the MD expansion phase will depend on results from the SD and MD~     dose-escalation phases and only if an acceptable safety profile is present. Subjects~     participating in the expansion phase are not allowed to have participated in the previous~     phases (SD and MD dose-escalation phases) of the trial.~   "
137003|NCT01261754|"~     This is a single-blind, randomized, cross-over design. Patients with metastatic prostate~     adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and~     healthy subjects will be administered a single intravenous dose of each of the study drugs~     99mTc MIP 1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.~   "
137004|NCT01261741|"~     In this study, memantine will be tested in a new indication: in the treatment of subjective~     memory, concentration, or attention problems (subjective cognitive impairment) in the~     absence of dementia.~   "
137007|NCT01261702|"~     All patients were premedicated with oral midazolam 5-15 mg. one hour before surgery. General~     anesthesia with double lumen endobronchial tube was given. Patient was induced by propofol~     and fentanyl. Cisatracurium was given to facilitate intubation. Patient was ventilated with~     50% oxygen in air. Anesthesia was maintained with propofol and fentanyl in order to keep~     blood pressure and heart rate within 20% of the baseline. Cisatracurium was given every 30~     minutes in order to control ventilation. At the end of surgery, neuromuscular blockade was~     reversed.In PACU, the I.V. PCA machine was connected to the patient. The setting of PCA was~     basal infusion of morphine 1 mg/hr bolus of morphine 1 mg with lockout interval 5 minutes~     and 4-hour limit 30 mg.The patient's mean arterial blood pressure, heart rate were recorded~     before induction, before intubation, at 15, 15, 30, 60, 90 and 120 minutes after intubation,~     and at 4, 8,16 and 24 h after surgery. The total amounts of fentanyl, propofol and magnesium~     sulphate were recorded. The time between the cessation of magnesium sulphate and extubation~     was recorded. The amounts of morphine usage at 4, 8, 16 and 24 hours after surgery were~     recorded. Pain score was evaluated at rest and deep breath and sedation score at 1, 2, 3, 4,~     8, 16 and 24 hours after surgery using numeric rating scale (NRS). Sedation score was graded~     as 0 = fully awake, 1 = somnolence, responds to call, 2 = somnolence, responds to tactile~     stimulation, 3 = asleep, responds to painful stimulation. The times that the patient first~     sipping, taking food, sitting at the edge of bed and walk with help were also recorded. The~     side effects such as nausea, vomiting, pruritus and respiratory depression were recorded.~     Cost effective analysis was also evaluated.~   "
137008|NCT01261689|"~     * The objective of the study: to assess the impact of a proactive policy of offering EA at~     the start of labour as compared to a restrictive policy or care as usual.~      * Study design: It concerns a multicentre randomised open label trial.~      * Study population: Term nulliparous and multiparous women with a child in cephalic~     presentation, and without contraindications for vaginal labour or EA.~      * Intervention: Women will be allocated to the EA group or the care-as-usual group. In the~     EA group, women are given an EA as soon as they are in labour. In the care-as-usual~     (restrictive) group, women receive pain relief only on their explicit request.~   "
137009|NCT01261676|"~     Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years.~     CSs have no clear benefit for overall neonatal outcome and are associated with higher~     maternal complications and high costs. Dutch guidelines offer clear recommendations on~     factors that have a direct effect on the decision to perform a CS.~      Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS~     among Dutch gynaecologists.~      This study consists of four phases:~        1. Development of quality indicators: A set of quality indicators regarding the process,~          structure and outcome of care will be developed according to the RAND-modified Delphi~          method. A representative, national expert panel consisting of 12 to 15 obstetricians~          and midwives will participate.~        2. Current care study: The current Dutch care will be studied in 20 hospitals (N=80~          gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to~          the developed quality indicators. To get insight into Dutch practices compared to~          international data, basic obstetrical data will be extracted from the delivery~          database.~        3. Barrier analysis: A barrier analysis will be carried out based on the results of the~          current care study. Two groups of hospitals will be identified in the upper and lower~          extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals~          with the highest adherence scores. Factors that determine the decision to perform a CS~          or not (barriers and facilitators) will be analyzed in both groups using~          semi-structured interviews among 15-20 professionals and 15-20 patients. A~          questionnaire will be used to study the 'prevalence' of these factors among all~          obstetric gynaecologists in the Netherlands and among 200 patients.~        4. Controlled before- and-after (CBA) study: Based on the outcomes of the current care~          study and the barrier analysis, a tailor made implementation strategy will be developed~          in order to increase adherence to the CS quality indicators. Target groups will be~          selected with focus on women with both a high incidence of the indicator and low~          indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12~          hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs.~          The sample size will be dependent on the target group and adherence to the quality~          indicators regarding this target group. These data will be available after performing~          the current care and the barrier study.~   "
137010|NCT01261663|"~     Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The~     consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting~     against malnutrition. Their use is easy, and framed by recent French recommendations~     suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no~     scientific data to affirm which is the best of these two hypothesis in elderly hospitalised~     in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in~     Limoges university hospital showed some problems about the mode of supplying NOS, partially~     linked with an insufficiency for paramedical staff in realizing importance of NOS. However,~     the effect of time of supplying NOS on total food consumption had not been evaluated in this~     first study. The new one will include 48 malnourished elderly patients in two LTCU and~     having a prescription of NOS. They will receive them at the same quantity during the whole~     study either firstly at end of meals (10 days) and secondly as snackings (10 days), or~     conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted~     by paramedical staff of the two units, and translated by dieticians in daily energy,~     protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with~     these intakes, in order to precise the best one.~   "
137011|NCT01261650|"~     Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic~     widespread pain present at a similar level for at least 3 months. The aim of this study is~     to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to~     reduce chronic pain.~   "
137012|NCT01261637|"~     This study has been designed to determine if women undergoing cesarean delivery with spinal~     anesthesia and routine pain management who also have an additional ultrasound guided~     transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a~     better quality of recovery than women who don't have the additional TAP block. Maximizing~     pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and~     acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially~     reduce chronic pain.~   "
137013|NCT01261624|"~     The present study has been designed in order to evaluate the efficacy and safety of two~     doses of Givinostat in subjects with polyarticular course JIA~      Givinostat ready-to-use suspension especially intended for paediatric administration, will~     be administered orally at different daily doses.~      Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA~     rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without~     active systemic features) will be enrolled.~      The treatment regimen will remain unchanged for 12 weeks and the clinical response will by~     assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR~     Pediatric 30 response will continue receiving the assigned dose for 12 further weeks.~      After the end of study (week 24) responder patients will be allowed to extend the treatment~     until they maintain a clinical benefit.~   "
137015|NCT01261598|"~     The poor prognosis in the early-stage of lung cancer is due to potential worsening of the~     disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual~     treatments.~      FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose~     consumption. Then, this exam is used for pathology staging, target volume definition for RT,~     and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam~     during the course of the RT or CRT might be predictive of the treatment efficiency few~     months later.~      In this study, the investigators propose to perform 4 FDG-PET: first PET1 before~     radiotherapy, second PET2 during the radiotherapy (see RTEP1), third and fourth PET3~     PET4 3month and 12 month after the therapy.~      The investigators will investigate the performances of FDG-PET performed during the RT or~     CRT for the prediction of the one-year patient heath outcome. If the predictive value of~     TEP2 is confirmed, the investigators would be able to optimize the planning treatment during~     the course of the therapy.~   "
137016|NCT01261585|"~     Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG),~     fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT)~     measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before~     and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive~     bronchial cancer.~      This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and~     the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive~     bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not~     small cell lung.~      The investigators are also going to study several scenarii of optimization of the~     radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the~     cellular proliferation measured in the course of radiotherapy (theoretical study on console~     using the scanner and the various examinations).~   "
137017|NCT01261572|"~     To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in~     patients with prostate cancer.~   "
137018|NCT01261559|"~     The primary hypothesis of this study is that breast displacement out of the direct plane of~     imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose~     to the female breast. Secondary hypotheses are that image noise and artifacts will also be~     decreased.~   "
137019|NCT01261546|"~     STUDY JUSTIFICATION~        1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases:~          Corticosteroids along with antibiotic use improve survival in some infectious processes~          provide long term benefits and improve symptoms in many others.~        2. Clinical Observation: the investigators observed that patients with parapneumonic~          pleural effusion and associated bronchospasm who were treated with corticosteroids for~          their bronchospasm, evolved to healing before patients who were not treated with~          corticosteroids (average admission days 10 vs. 17).~        3. Rationale: the anti-inflammatory effect has been the rationale for the use of~          dexamethasone as an inhibitor of the inflammatory response observed after the first~          dose of parenteral antibiotic in bacterial meningitis. A similar effect is likely to~          occur in pneumonia with pleural effusion. It can be therefore hypothesized that~          Dexamethasone could inhibit an excessive inflammatory response by mesothelial and~          inflammatory cells during the early phases of parapneumonic empyema, reducing its~          severity and hence its complications.~      OBJECTIVES~        1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard~          antibiotic therapy reduces time to resolution of parapneumonic pleural effusion.~        2. Secondary:~      2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic~     therapy on the development of complications during pleural effusion episode.~      2.2. Evaluate the incidence of severe and non severe adverse events associated with the new~     treatment versus standard therapy.~      METHODS~        1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled,~          parallel stratified design, multicentric.~        2. Participating Hospitals (n=56, 7 patients per center):~             -  Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).~             -  Hospital Universitario de Getafe~             -  Hospital Universitario Ramón y Cajal, Madrid.~             -  Hospital Universitario Materno-Infantil Carlos Haya, Málaga.~             -  Hospital Infantil La Paz, Madrid.~             -  Hospital U. Gregorio Marañón~             -  Hospital U. Príncipe de Asturias~             -  Hospital Virgen de la Salud, Toledo~        3. Endpoints:~           3.1. Primary: time to resolution. 3.2. Secondary endpoints:~             1. Effectiveness: number of children with complications.~             2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal~               bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic~               reaction vi) Other adverse reactions described in the Medication Guide.~        4. Treatment arms:~      3.1. Control (0)~        -  Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.~        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present.~        -  Ranitidine 5 mg/kg IV, q.d. for 2 days.~        -  Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.~      3.2. Study treatment: (1)~        -  dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.~        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present~        -  Ranitidine 5 mg/kg IV, q.d. for 2 days~        -  Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.~           4. INCLUSION CRITERIA~        -  Patients between 1 and 14 year old.~        -  Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and~          radiological consolidation.~        -  Evidence of pleural effusion.~   "
137020|NCT01261533|"~     The purpose of this study is to determine the feasibility, primary safety and efficacy of~     foldable capsular vitreous body (FCVB) in the treatment of retinal detachment, based on the~     multi-center clinical trial.~   "
137021|NCT01261481|"~     The purpose of the study is to compare the relative bioavailability and pharmacokinetics of~     tolvaptan 15 mg tablets administered orally versus tolvaptan via nasogastric (NG) tube in~     healthy male and female subjects.~      This study is an open 2-treatment, 2-period, 2-sequence crossover study to compare the~     relative bioavailability of tolvaptan tablets to tolvaptan given via nasogastric tube in 28~     healthy adults. Subjects will be randomized to one of the two treatment sequences; either~     tolvaptan oral tablets swallowed intact followed by a tablet crushed and administered via~     nasogastric tube, or the reverse sequence. Serial pharmacokinetic samples will be collected~     following each tolvaptan administration and safety assessments will be performed. The~     relative bioavailability of tolvaptan administered via nasogastric tube will be compared to~     tolvaptan tablets swallowed intact.~   "
137022|NCT01261468|"~     The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory~     parameters, using quantitative sensory testing (QST).~      Patients with established SCS treatment will be examined with QST. Subjects will be~     randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period,~     then be reexamined using the same QST protocol.~      After the 2nd examination all patients cross over (ie. inactive devices are activated,~     active devices are deactivated) and are reexamined after a new 12-hour period.~      The investigators expect to demonstrate that SCS treatment has a significant effect on~     sensory parameters associated with pain hypersensitivity but no significant effect on~     sensory parameters associated with detection of non-painful stimuli.~   "
137023|NCT01261455|"~     The purpose of this study is to determine if there is any difference in the surgical time~     when the surgery is performed with a graft taken from under the upper lid versus lower lid.~     The investigators will also be recording the level of pain felt by patients after surgery,~     any difficulties during or after surgery, and if the pterygium grows back.~   "
137024|NCT01261442|"~     The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients~     with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.~     This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve~     (PTN) as measured by ultrasound is increased in patients with distal symmetric~     polyneuropathy (DSPN) as compared to diabetic patients without DSPN.~   "
137025|NCT01261429|"~     The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients~     with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell~     tumour (PVNS/TGCT) who cannot be treated by surgery.~      The primary objective of the study will be to determine the efficacy of 12 weeks (3 months)~     of nilotinib treatment as measured by the non progression rate (Complete response + Partial~     Response + Stable disease according to Response Evaluation Criteria In Solid Tumours -~     RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be~     treated by surgery.~      this study is an international, multicentre, non-randomized, open-label phase II clinical~     trial with a Bayesian design.~      A maximum sample size of 50 patients will be included in the study~   "
137026|NCT01261416|"~     The primary objective of this study is to determine the pharmacokinetic profile of a loading~     dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm~     infants with seizures. Secondary objectives are to evaluate the safety and efficacy of~     levetiracetam in term and preterm infants with seizures.~   "
137027|NCT01261403|"~     The primary objective of the study is to assess the safety and efficacy of 2 dose groups~     (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary~     objectives of the study are to determine the clinical response at defined visit intervals,~     determine the time to flare of RA symptoms and to quantify changes in inflammatory markers~     including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A~     (SAA), and IL-6.~   "
137028|NCT01261390|"~     Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a~     common health problem that is often associated with loud snoring and sleepiness.The medical~     term for this problem is obstructive sleep apnea (OSA). People with OSA often have an~     increased risk for developing heart disease or may already have a diagnosis of heart~     disease.~      A clinical research study is being conducted at Brigham and Women's Hospital and Beth Israel~     Deaconess Medical Center to compare the effects of continuous positive airway pressure~     (CPAP) to conservative medical therapy with participation in one of four groups:~        -  CPAP Therapy Group: Standard medical treatment for sleep apnea, with CPAP mask worn~          during sleep. Participants randomized to either Respiratory Therapist (RT)only or RT~          with Cognitive Behavioral Therapist.~        -  Alternative CPAP Group: Different air delivery level from mask than CPAP Therapy Group.~          RT meetings.~        -  Conventional Medical Therapy (CMT) Group: Receive one year supply of nasal strips and~          follow guidelines for how to change sleep habits to minimize apnea.Frequent follow-up~          support with research coordinator.~      A sleep doctor or cardiologist will have indicated that a potential participant is an~     appropriate candidate to receive CPAP or CMT as acceptable approaches to treat his/her sleep~     apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed~     heart disease or between 55-75 years for those who have risk factors for developing heart~     disease.~      This is a 12 month study* to evaluate alternative ways to address the potential for OSA~     treatment to reduce heart disease and to identify those features that would strengthen a~     later, large-scale randomized controlled trial.~      *For those randomized after December 31, 2012, the study will be 6 months long.~      We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity~     and mortality.~   "
137029|NCT01261377|"~     Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management~     is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen~     to asses the impact of intervention on cardiac MRI and biomarkers.~   "
137030|NCT01261364|"~     Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive~     report improves outcomes when compared with standard treatment without the availability of~     genetic information.~   "
137031|NCT01261351|"~     The primary purpose of the trial is to evaluate coagulation activator markers in patients~     with pre eclampsia compared to control (normal pregnancy) and to correlate these markers~     with the severity of the pathology.~   "
137032|NCT01261338|"~     Because of industrial pollution, a large number of people in Annison, Alabama, have elevated~     body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is~     evidence that these compounds are associated with risks to health including diabetes. There~     is also evidence that the consumption of a non-absorbable dietary fat can reduce the level~     of compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable~     dietary fat can reduce the levels of PCBs in subjects in Anniston.~   "
137033|NCT01261325|"~     This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and~     200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with~     partial onset seizures not fully controlled despite current treatment with 1 or 2~     concomitant antiepileptic drugs.~   "
137034|NCT01261312|"~     Phase 1-2 dose escalation randomized study in patients with intermediate or high risk~     myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation~     Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110~     with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will~     further evaluate safety and efficacy at the biological effective dose (BED) or maximum~     tolerated dose (MTD)as defined in the Dose Escalation Segment.~   "
137035|NCT01261299|"~     Carboplatin kills cancer cells mainly through induction of DNA damage (drug-DNA adducts).~     The goal of this clinical trial is to determine if chemoresistance to carboplatin can be~     identified by measuring carboplatin-induced DNA monoadducts, the precursor of Pt-DNA~     diadducts or crosslinks, from subtherapeutic drug doses given prior to the initiation of~     chemotherapy. We hypothesize that low levels of carboplatin-DNA monoadducts and rapid~     drug-DNA adduct repair correlate with chemoresistance. A highly sensitive technology, called~     accelerator mass spectrometry (AMS), will be used to measure carboplatin-DNA monoadducts~     from patient samples. AMS can measure C-14 at the attomole level in specimens of milligram~     size. In this study, patients will receive one non-toxic microdose (defined as 1/100th the~     therapeutic dose) of C-14-labeled carboplatin. Blood specimens will be drawn for~     determination of carboplatin-DNA monoadduct formation and repair in peripheral blood~     mononuclear cells (PBMC), and pharmacokinetics (PK) will be determined from serum~     ultrafiltrate. In patients microdosed prior to providing tumor samples, a few milligrams of~     leftover tumor biopsy/resection specimens will be analyzed for formation of carboplatin-DNA~     monoadducts. Patients will subsequently receive carboplatin-based chemotherapy. The levels~     of microdose-induced carboplatin-DNA monoadducts will be correlated with response to~     chemotherapy. Some blood and biopsy samples will be assayed by RT-PCR for several putative~     resistance markers at the mRNA level. Side effects will also be monitored and compared to~     the AMS data. This trial will also utilize PK, DNA repair and pharmacogenomics data in order~     to determine some of the underlying chemoresistance mechanisms.~   "
137036|NCT01261286|"~     Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab~     treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type~     calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.~      Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished~     dromotropic response to verapamil; the concentration of circulating norepinephrine, used as~     a surrogate marker of sympathetic nervous activity, will be similar between the healthy~     patients and the CD patients; the sympathetic nervous system of the heart will be similar to~     healthy patients; Crohn's disease patients with normal CRP will have higher drug response~     compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have~     higher verapamil response than those with similar symptom profiles who are not infliximab~     treated.~   "
137037|NCT01261273|"~     Title Prospective, single-arm, multi-centre, observational registry to further validate~     safety and efficacy of the Nobori® DES in real-world patients.~      Objective Primary objective The primary objective of e-NOBORI registry is to further~     validate the safety and efficacy of Nobori® DES system in unselected patients representing~     everyday clinical practice.~      Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac~     death, target vessel related myocardial infarction (MI) and clinically driven target lesion~     revascularization (TLR) at 1 year~   "
137060|NCT01260974|"~     The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to~     demonstrate in particular the effectiveness, understood as the ability to reduce the~     incidence of invasive fungal infections, and to assess the ability to reduce the risk and~     incidence of side effects (toxicity) which may arise in transplant patients treated with~     other drugs, especially in individuals recognized as high risk (e.g. renal failure).~   "
137038|NCT01261260|"~     On the dual basis of findings indicating GABA increases following acute and eight week~     SSRI/dopamine agonist administration and those indicating GABA-ergic effects following 14~     day pyrimidine administration, the purpose of this study is to assess our following~     hypotheses:~        1. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase~          brain GABA levels in a sample of healthy, unmedicated adult males;~        2. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase NTP~          levels in a sample of healthy, unmedicated adult males; and~        3. Brain GABA levels will be directly correlated to high energy phosphate levels in this~          sample of healthy, unmedicated adult males.~   "
137039|NCT01261247|"~     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. This phase II trial is studying how well panobinostat works in treating~     patients with relapsed or refractory non-Hodgkin lymphoma~   "
137040|NCT01261234|"~     CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to~     that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting~     (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective~     Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS.~     900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis~     after CAS, evaluated by carotid ultrasound and angiography.~   "
137041|NCT01261221|"~     Kaohsiung Medical University Chung-Ho Memorial Hospital will provide a long-term free~     medical service in Indian Tibetans since July 2010. The investigators plan to investigate~     metabolic syndromes and HIV infection in Indian Tibetan community. The investigators will~     survey the prevalence and risk factors by means of HIV quick test and questionnaires. Since~     there is lacking of prevalence survey for metabolic syndrome and HIV infection in Tibetan~     colony of India, the investigiators will carry out this survey under the support and~     assistance of Department of Health of Central Tibetan Government.~   "
137042|NCT01261208|"~     The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection~     among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in~     Kaohsiung Medical University Hospital and collect the cases who were suspicious of~     Helicobacter Pylori infection.~   "
137043|NCT01261195|"~     HUVEC primary cells for researches about the relation between plasma leakage and infections.~   "
137044|NCT01261182|"~     School feeding programs provide students meals conditional on school attendance, which can~     have impacts on school participation, cognition and learning, and nutritional outcomes.~     Although the literature on impacts of school feeding programs is substantial, high quality~     studies with evaluation designs that provide causal impact estimates are relatively few.~     Thus program impacts on educational, cognitive and nutritional outcomes are not~     well-understood, particularly in a field setting. Nutritional impacts in particular are~     questionable, which may be a result program design. Most studies provide only small~     transfers to children and examine average macro-nutrient effects of the transfer on the~     treated children, thus it is not surprising that detection of nutritional gains has been~     minimal.~      This study is a cluster-randomized evaluation of a school feeding program administered by~     the World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program~     provides substantially larger food rations than most programs (representing 1/3 of~     children's daily caloric needs and 99% of iron intake requirements).~      The key research objectives are:~        1. Impact on the treated: Assess the effectiveness of the program at improving nutritional~          status, education and cognitive and learning outcomes for school-age children, with~          particular attention to the anemia status of older school-age girls .~        2. Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness~          of the program at reducing anemia prevalence in mothers and younger siblings.~        3. Optimal program design: Assess the differential impacts of a program in which children~          are fed at school compared with one in which they are given dry rations to bring home.~   "
137045|NCT01261169|"~     This study is designed to explore the use of Myfortic® in patients with steroid-refractory~     uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in~     managing uveitis patients.~   "
137046|NCT01261156|"~     The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics~     (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.~   "
137047|NCT01261143|"~     The purpose of this study is to determine the:~      Primary end point~        -  change of Total symptom score~      Secondary end point~        -  neurological test~   "
137048|NCT01261130|"~     This two part study will evaluate the safety and immunogenicity of two formulations of~     Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults~     living in an area of endemic hookworm infection using a randomized, double-blind design. The~     two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and~     Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.~   "
137049|NCT01261117|"~     To determine whether oral or intravenous ibuprofen has a better or same efficacy and~     tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm~     infants.~   "
137050|NCT01261104|"~     Purpose: to investigate the relationship between time for treatment seeking and audiometric~     data and self-assessment of handicap for patients in a public hearing healthcare service.~     Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment~     were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies~     average (2000 to 6000Hz), the speech recognition thresholds and the total, social and~     emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly~     (HHIE) were compared with the time between the onset of hearing complaints and the first~     treatment seeking. Results: The average time for treatment seeking was 7,6 years. No~     statistical difference was found between ISO and high frequency audiometric average, HHIA/E~     scores and time for treatment seeking between adults and the elderly. Weak but significant~     negative correlations were observed between the audiometric data and time for treatment~     seeking. There was no relationship between the time for treatment seeking and educational,~     socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems~     to be multifactorial. Despite technological advances and changes in access to information~     and treatment time for treatment seeking was similar to that reported 30 years ago.~   "
137051|NCT01261091|"~     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,~     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal~     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal~     tube below the larynx. This so called tracheostomy might be associated with advantages such~     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth~     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for~     tracheostomy in stroke, however, is not known. This study investigates the potential~     benefits of early tracheostomy in ventilated critically ill patients with ischemic or~     hemorrhagic stroke.~   "
137052|NCT01261078|"~     Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or~     increase the quality of anesthesia. However, there is still a controversy, and the mechanism~     of epinephrine is recently suggested as a modulator of pain information in the spinal cord.~     Therefore, the investigators try to investigate the dose sparing effect of intrathecal~     epinephrine for spinal anesthesia with bupivacaine.~   "
137053|NCT01261065|"~     The overall hypothesis of this application is that the improvement in LV ejection~     performance following treatment with betablockers is due, at least in part, to improvement~     in intrinsic myocardial contractility.~   "
137054|NCT01261052|"~     The purpose of this research study is to test an automated blood glucose control system that~     includes a new component designed to adapt to stress. The importance of this component is~     that when Type 1 Diabetics are stressed (for example, from illness or infection), their body~     is resistant to the effects of insulin. The investigators will be adjusting their blood~     glucose using insulin and glucagon and making their body less sensitive to insulin with a~     steroid, hydrocortisone. Insulin is a hormone that lowers blood glucose. Glucagon raises~     blood glucose when it is low. Both are natural hormones made by people without diabetes.~     Hydrocortisone is a steroid that will increase their blood glucose temporarily and will be~     given every 4 hours. All subjects will participate in two 33 hour experiments. One~     experiment will use the adaptive version of the sensor-based glucose control system. The~     other study will use the original version of the control system, without the adaptive~     component, for the first 13 hours. Then, the adaptive component will be added to the glucose~     control system for the remaining 20 hours of the study. Our primary goal is to assess the~     effectiveness of the adaptive component to control glucose levels in the presence of~     steroid-induced insulin resistance in persons with Type 1 Diabetes Mellitus.~   "
137055|NCT01261039|"~     Background:~      Some patients do not readily absorb vitamin D from intestine. These patients may be helped~     by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to~     ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is~     exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or~     supplements.~      Vitamin D is important for bone, and long-term vitamin D deficiency can lead to~     osteoporosis. Vitamin D may also be important for the immune system—including autoimmune~     diseases—and the cardiovascular system.~      Purpose:~      The main purpose of the study is to learn more about the production of vitamin D3 in the~     skin, by ultraviolet radiation.~      Study Course:~      Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be~     exposed to light in a solar bed for approximately 10 minutes on the first day, but only one~     of the solar beds wields ultraviolet rays. The other has a filter, which filters out the~     ultraviolet rays.~      Blood samples are drawn on the first day at following times: Before solar bed, after at 15~     minutes, 1, 2, 4 and 6 hours.~      Day 1,2,3 and 7 after solar bed exposure:~      Blood samples are drawn and adverse events are registered.~   "
137056|NCT01261026|"~     OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF)~     concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP)~     and normal intrauterine pregnancy (nIUP).~      METHODS: This was a prospective, case-control study comparing serum VEGF concentrations~     among 72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22)~     matched for gestational age. For the determination of serum VEGF concentration a solid phase~     sandwich ELISA was used. Patients were stratified according to serum VEGF above or below~     200pg/mL.~      RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy~     (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL;~     range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically~     significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL )~     and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL~     for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a~     sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative~     predictive value of 46.5%..~      CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF~     concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or~     aIUP) with a PPV of 92.9%.~   "
137057|NCT01261013|"~     The purpose of this study is to properly analyse the visual and refractive outcomes of~     implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of~     keratoconus.~   "
137058|NCT01261000|"~     Acromegaly is a disease of the pituitary gland that involves the overproduction of growth~     hormone. The drug works by blocking the binding of growth hormone to growth hormone~     receptors found in tissues throughout the body. Human studies have evaluated the reduction~     of IGF-I levels in the blood following pegvisomant treatment, however, no studies have~     evaluated IGF-I levels in tissues following pegvisomant administration. In this study, we~     will test a novel tissue biomarker for pegvisomant action, distinct from measuring IGF-I~     levels in the blood. To this end, we will determine if administration of pegvisomant~     modifies the expression of IGF-I, IGF-I receptor, growth hormone receptor and GH- and~     IGF-i-dependent signaling molecules in the colon tissue of patients with acromegaly.~   "
137059|NCT01260987|"~     Nodular Basal Cell Carcinomas:~      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for~     difficult to treat nodular cell carcinomas in the face.~      Actinic keratosis:~      Compare the efficacy and safety of conventional versus fractional laser assisted PDT for~     moderate to severe actinic keratoses located in the face and on the hands.~   "
137262|NCT01257113|"~     The purpose of this study is to determine whether there are any difference between~     supervised exercise therapy and homebased exercise when looking at pain and function for~     patients with shoulder pain.~   "
137061|NCT01260961|"~     Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are~     starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3~     fatty acid found in the brain and a component of fish oil, has any effects on the symptoms~     of autism.~      We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with~     no drug in it) on several aspects of autism in children and adolescents, in a 12-week~     clinical study with children or adolescents in the age group of 5-17 with a diagnosis of~     Autism Spectrum Disorder. Additionally this trial will study genes related to the~     therapeutic agent, DHA, and biomarkers related to DHA in the urine.~   "
137062|NCT01260948|"~     This study investigated the relative bioavailability (rate and extend of absorption) of~     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA~     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai~     Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult~     subjects administered under non-fasting conditions.~   "
137063|NCT01260935|"~     The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill~     anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see~     whether one is better than the other.~   "
137064|NCT01260922|"~     This study investigated the relative bioavailability (rate and extent of absorption) of~     Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA~     with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai~     Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult~     subjects administered under fasting conditions.~   "
137065|NCT01260909|"~     In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal~     X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose~     delivery typically takes 2 to 5 minutes depending on the delivery technique used for~     treatment. A tumor target may change its position during the dose delivery process. The goal~     of this project is develop a real-time imaging strategy to monitor the tumor position during~     dose delivery and evaluate its potential clinical impact.~   "
137066|NCT01260896|"~     The objective of this study was to compare the rate and extent of absorption of venlafaxine~     hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)~     administered as 1 x 150 mg extended-release capsule under fasting conditions.~   "
137067|NCT01260883|"~     Infants handle ketorolac differently than adults. Study of handling of this pain medication~     given to infants following surgery. Detailed analysis of how the drug is eliminated from age~     2 months to 18 months. Compared morphine use in infants who received the drug to the group~     getting placebo. Safety testing for kidney and liver function, breathing measured by~     continuous oximetry, and any bleeding issues.~   "
137068|NCT01260870|"~     To evaluate the procedural safety and to identify and characterize therapeutic and~     functional endpoint assessments in subjects with documented critical limb ischemia who~     received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA~     only.~   "
137069|NCT01260857|"~     Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2~     follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and~     secondary outcomes, respectively.~   "
137070|NCT01260844|"~     Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte~     pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe~     psoriasis.~   "
137071|NCT01260831|"~     The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning~     System (Bedside-PEWS) on early identification of children at risk for near and actual~     cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.~   "
137072|NCT01260818|"~     Tranexamic acid has been shown to reduce postoperative blood losses and transfusion~     requirements in a number of types of surgery. Most trials in orthopedic surgery have been~     conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would~     aim to see the effect of topical use of tranexamic acid in reduction of blood loss and~     transfusions for total hip arthroplasty~   "
137073|NCT01260805|"~     A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the~     Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify~     through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene~     0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under~     fasting conditions.~   "
137074|NCT01260792|"~     Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not~     validated in France. This clearly hampers the development of the diagnosis and the~     monitoring of patients but also research in this domain. This study is conceived to collect~     data in the general population of children aged from 4 to 18 years in public schools in the~     city of Nice.~      Children are pseudo-randomly selected from classes of randomly selected schools in the city~     of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and~     ask parents to fill out a similar set of questionnaires regarding their child's behaviour at~     home. Since ADHD has a strong genetic components, parents are also asked to fill out~     questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.~      Additionally, known factors related to ADHD and other disorders as well as other putative~     factors are tested in the epidemiologic study.~   "
137075|NCT01260779|"~     This compassionate use protocol provides expanded access for investigational use of PV-10 in~     cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is~     no comparable or satisfactory approved alternative therapy and whom, in the opinion of the~     investigator, may benefit from PV-10 administration.~   "
137076|NCT01260766|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
137077|NCT01260753|"~     The purpose of this study is to explore the activity of UR-63325 in a model of allergic~     rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise~     healthy.~   "
137114|NCT01260272|"~     This trial compared the effects of raisin intake on cardiovascular risk factors compared to~     common, commercially available, alternative snacks. These cardiovascular risk factors~     include glucose, blood pressure, lipid levels, body weight, and waist circumference.~   "
137297|NCT01258088|"~     The purpose of this study is to determine how much drug is absorbed throughout the body~     after being applied to the skin.~   "
137078|NCT01260740|"~     Background:~      - Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and~     motor cortex (MC), play a key role during learning. Researchers are interested in~     determining the effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has~     on participants' performance of learning tasks. By studying the effect of TMS on reaction~     time, learning, and memory, researchers hope to better understand how to treat conditions~     such as Parkinson's disease and traumatic brain injury that affect these parts of the brain.~      Objectives:~        -  To study the effects of transcranial magnetic stimulation on the dorsolateral~          prefrontal cortex and motor cortex.~        -  To learn which areas of the brain are used to perform certain learning and memory~          tasks.~      Eligibility:~      - Healthy, right-handed individuals between 18 and 70 years of age.~      Design:~        -  Participants will be screened with a physical and neurological examination and a~          medical and psychiatric history.~        -  Participants will be asked to take part in one of five different parts of this study.~          Most participants will have four 2-hour visits to the National Institutes of Health~          Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour~          visit.~        -  Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task~          that may provide a small monetary reward. On the first visit, before the TMS,~          participants will take an intelligence test based on reading aloud the words given on a~          card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of~          the brain within the past year will also have a scan.~        -  Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a~          learning task that may provide a small monetary reward. On the first visit, before the~          functional MRI, participants will take an intelligence test based on reading aloud the~          words given on a card. Participants who have not had a routine magnetic resonance~          imaging (MRI) scan of the brain within the past year will also have a scan.~        -  Part 5 (one visit): Participants will take an intelligence test based on reading aloud~          the words given on a card. Then, participants will have TMS followed by a functional~          MRI scan. During the functional MRI, participants will do a button-pressing task that~          may provide a small monetary reward.~        -  Participants will also be asked to provide a small blood sample for genetic analysis.~   "
137079|NCT01260727|"~     The purpose of this study is to evaluate the safety of and immune response to an HIV~     vaccine, administered using two different devices, followed by a vaccine boost, in healthy,~     HIV-uninfected adults.~   "
137080|NCT01260714|"~     This phase I trial studies the best dose of azacitidine and to see how well it works with~     mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid~     leukemia that has a lower chance of responding to treatment or higher risk of returning~     (poor prognosis). Drugs used in chemotherapy, such as azacitidine, mitoxantrone~     hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving more than one drug~     (combination chemotherapy) may kill more cancer cells.~   "
137081|NCT01260701|"~     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating~     patients with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
137082|NCT01260688|"~     This randomized phase II trial is studying the side effects and how well giving cediranib~     maleate together with or without dasatinib works in treating patients with hormone-resistant~     prostate cancer resistant to treatment with docetaxel. Cediranib maleate and dasatinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by~     blocking blood flow to the tumor. It is not yet known whether giving cediranib maleate~     together with dasatinib or alone is an effective treatment for prostate cancer.~   "
137083|NCT01260675|"~     Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.~   "
137084|NCT01260662|"~     This will be a randomized trial of propofol versus the combination of propofol and ketamine~     for procedural sedation for procedures in the Emergency Department (ED). Propofol produces~     sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County~     Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is~     also frequently used in the ED in children and sometimes in adults. It has been proposed~     that by combining the two agents, the negative side effects of respiratory depression and~     hypotension associated with propofol, and the negative effects of dysphoria and vomiting~     associated with ketamine, can be avoided.~      In the proposed study, patients seen in the ED who will require procedural sedation for a~     painful procedure will be randomized to receive either propofol or propofol and ketamine.~     During the procedure, patients will be monitored per the standard of care, including use of~     a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample~     end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully~     completed and the patient has returned to his/her baseline mental status, the patient will~     be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure,~     memory of the procedure, and overall satisfaction with the procedure.~   "
137085|NCT01260649|"~     Electroconvulsive therapy (ECT), is considered the most effective treatment for severe~     treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of~     treatments and can cause considerable acute deficits in memory. It would be a major advance~     in treatment if ECT could work faster with fewer treatments and result in decrease incidence~     of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of~     its acute effects on depression, its short half-life, and its safety profile when given at~     low doses. Ketamine is given as an infusion and could easily be incorporated into the~     routine management of patients undergoing ECT, but has never been evaluated prospectively in~     this context.~      The investigators propose to assess the efficacy, feasibility, tolerability and safety of~     N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.~   "
137086|NCT01260636|"~     To compare two gadolinium contrast agents in terms of global paired diagnostic preference~     (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid,~     renal/abdominal and peripheral arteries~   "
137087|NCT01260623|"~     The objective of the investigators pilot study is to assess the pharmacokinetic profile of~     two corticosteroid drugs, prednisone and prednisolone, in children who present to the~     pediatric emergency department with an asthma exacerbation. The investigators hypothesis is~     that the pharmacokinetic profile in this population will be similar to healthy children and~     adults.~   "
137088|NCT01260610|"~     Combination therapies using nucleos(t)ide analogues lead to higher viral suppression~     although it may not be sustained for long. Also it remains unknown if combination of more~     potent analogues is more beneficial than individual drugs. Thus this study is carried out to~     determine the efficacy and safety of combination of tenofovir plus telbivudine (two most~     potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week~     open labelled, prospective, randomized, multicentric study. The patient will receive either~     tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the~     non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will~     continue receiving tenofovir plus telbivudine for 104 weeks.~   "
137204|NCT01259089|"~     Hsp90 inhibitor AUY922 and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the~     side effects and best dose of Hsp90 inhibitor AUY922 when given together with erlotinib~     hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small~     cell lung cancer.~   "
137089|NCT01260597|"~     The purpose of this proposed study is to develop, refine and test the use of Interactive~     Voice Response (IVR) technology as a means of increasing re-engagement of low income smokers~     in telephone support for tobacco cessation (quit lines). If this strategy proves to be~     acceptable and feasible, it may offer a technological solution to increase access to and~     utilization of a widely available evidence-based form of behavioral treatment for low income~     smokers.~      The primary aims of this research are to:~        1. Develop an IVR system that delivers tailored audio messages to increase low income~          smokers' re-engagement in treatment offered by two state quit lines (Washington and~          Indiana). The investigators will develop: a) a menu of audio messages that can be~          delivered by an IVR system; b) an IVR algorithm (i.e., a set of decision rules) to make~          proactive automated calls to deliver brief, tailored messages for re-engaging low~          income smokers who previously used the quit line.~        2. Evaluate the feasibility and efficacy of an IVR system as a tool to re-engage low~          income smokers into quit line treatment measured by number of IVR calls answered,~          number of smokers who re-engage in treatment and satisfaction with IVR calls.~          Hypothesis 2.1 - It is hypothesized that the rates of re-engagement into treatment~          among those receiving the IVR intervention will be higher than smokers not proactively~          invited to re-engage in quit line services.~   "
137090|NCT01260584|"~     This study is being conducted to determine if smoking will influence the platelet~     aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if~     smoking has any effect on the plasma concentrations of the active metabolite of prasugrel~     and the active and inactive metabolites of clopidogrel.~      The primary hypothesis is that smoking status will influence the antiplatelet effects and~     active metabolite concentrations of clopidogrel but will have no impact on prasugrel's~     antiplatelet effects or active metabolite concentrations.~   "
137091|NCT01260571|"~     Sixty two subjects will take part in this study. The study is unic arm. The subjects used~     the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and~     24 hours after application.~      A follow-up visit will be made 24 hours after initiation of treatment.~   "
137092|NCT01260558|"~     The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with~     the PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.~   "
137093|NCT01260545|"~     The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects~     with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha~     blockade.~   "
137094|NCT01260532|"~     Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD~     include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD~     remains unclear, it is generally thought that the mechanisms of the disease is a complex~     disease in which susceptibility genes and environmental triggers act in concert to initiate~     the autoimmune response to the thyroid.~      The initial step of thyroid autoimmunity is the activation of T cells. The activation of T~     cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells~     binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells~     is also required the interaction of costimulatory molecules between thyroid follicular cells~     and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear~     transcription factor, associated with adipogenesis and inflammation. Some reports showed~     that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.~      The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory~     molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics~     in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and~     PPAR- polymorphism in AITD.~   "
137095|NCT01260519|"~     The project tests the incidence of femoral arterial sheath thrombus formation during~     diagnostic coronary angiography and effect of intravenous (iv) heparin bolus administration~     in reducing this risk in comparison to placebo.~   "
137096|NCT01260506|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in~     patients with Relapsed Glioblastoma Multiforme.~   "
137097|NCT01260493|"~     The present study Continuum of care for frail elderly people form part of the research~     programme Support for frail elderly persons - from prevention to palliation~     (www.vardalinstitutet.net) which comprises research into three interventions. The program~     comprises interventions addressing frail elderly people in different phases of the~     disablement process, from elderly people who are beginning to develop frailty to very frail~     elderly people receiving palliative care.~      The intervention Continuum of care for frail elderly people addresses elderly people who~     are frail and that have a great risk of high health care consumption. The hypothesis is that~     an intervention program for frail elderly people can reduce the number of visits to the~     emergency department, increase the life satisfaction and maintain the functional ability.~     The intervention, including an early geriatric assessment at the emergency department, early~     family support, a case manager in the community with a multi-professional team and active~     follow-up by the case manager, contributes to early recognition of the elderly people's need~     of information, care and rehabilitation and of informal caregivers' need of information. It~     enhances the transfer of information and integrates the care between different caregivers~     and different care levels, thereby better recognize frail elderly people's needs.~     Specifically, this study is expected to show that the intervention has a positive effect on~     the frail elderly person's functional ability, life satisfaction, satisfaction with health~     and social care, and health care consumption.~   "
137098|NCT01260480|"~     The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET~     imaging is effective as an imaging tool for the early detection of response of oncological~     tumors in the lungs,head and neck to chemoradiation therapy.~      The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to~     distinguish early during the course of chemoradiation therapy between a tumor that responds~     to the therapy, and a tumor that does not respond to the therapy. Currently, this~     distinction is available to the physician several weeks or months after completion of~     therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic~     Resonance Imaging [MRI]).~   "
137205|NCT01259076|"~     Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss~     affects breast density in women who are at increased risk for breast cancer.~   "
137099|NCT01260467|"~     The purpose of this study is to determine if a medication called memantine is effective in~     treating glioblastoma. Memantine targets a specific receptor, called a glutamate receptor,~     which is thought to be involved in the growth of brain tumors. It has previously been~     studied for other types of conditions, such as Alzheimer's disease, but it has not yet been~     evaluated in the treatment of brain tumors. The investigators will also be determining how~     common it is for patients with brain tumors to have side effects to memantine. Memantine~     will be taken by mouth twice a day.~   "
137100|NCT01260454|"~     Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial~     hypertension, a life threatening disease of the lung blood vessels. Unfortunately,~     treprostinil is irritating to the skin and many patients experience intense pain at the~     infusion site for the first 7-10 days after placing a new subcutaneous infusion site.~      Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of~     post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that~     pretreatment of an area of skin with Qutenza would decrease the pain associated with a new~     treprostinil infusion site. The investigators hope that Qutenza will decrease both the~     intensity of the pain and the duration of the pain after patients place a new treprostinil~     infusion site.~      In this initial study, the investigators will provide Qutenza in open-label, unblinded~     fashion and ask patients to rate their pain using a diary tool with which they are already~     comfortable.~   "
137101|NCT01260441|"~     Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of~     them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5%~     survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate~     and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander~     CPR. Studies have shown that prompt administration of CPR dramatically improves outcomes. In~     a recent study from Switzerland, lay bystander CPR doubled the survival rate at one month.~     Our study will look to train family members of at-risk cardiac patients in the skills of CPR~     through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal~     Learning Program (CPR Anytime) to see if these family members are able to learn and perform~     quality CPR in the event that their family member should suffer a cardiac arrest.~   "
137102|NCT01260428|"~     Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present~     study is to investigate whether increased expiratory pressure within the thorax is able to~     improve oxygenation during hypoxic hypoxia.~   "
137103|NCT01260415|"~     This is a phase II study to assess whether treatment with chemotherapy drugs FOLFOX~     (5-Fluorouracil (5FU), Oxaliplatin (Eloxatin) and Leucovorin (Folinic Acid)) or FOLFIRI~     (5-Fluorouracil (5FU), Irinotecan (Camptosar) and Leucovorin (Folinic Acid))and panitumumab~     before and after surgery can improve outcome in patients with liver metastases (the cancer~     has spread to other parts of the body such as the liver) that are resectable (can be~     surgically removed), from colorectal cancer that have a non mutant (wild-type) K-ras gene.~      FOLFOX/FOLFIRI is an intravenous (given by vein) chemotherapy combination that is approved~     for colorectal cancer while panitumumab is also an intravenous drug and have been approved~     for treatment of refractory (not responding treatment) metastatic colorectal cancer whose~     cancers have the K-ras gene. These drugs are not approved for the treatment of colorectal~     cancer liver metastases (CRCLM) who can have surgery.~      Patients will receive FOLFOX/FOLFIRI and panitumumab for four 2-week cycles before surgery.~     Surgery will be done no sooner than 4 weeks and no later than 8 weeks, after completion of~     the fourth cycle of chemotherapy.~      If the liver metastases after the chemotherapy and surgery decreases or stops growing, then~     chemotherapy will be given after surgery. Treatments will start no sooner than 4 weeks, and~     no later than 12 weeks, after surgery. Patients will receive a maximum of 8 cycles of~     treatment with the combination of drugs and then receive panitumumab alone for a maximum of~     12 cycles.~      On treatment visits, patients will also have tests and procedures done. As part of the~     study, patients will provide archival tumor tissue and sample of tissue removed from surgery~     for K-ras testing. Patients will also be given the option of allowing the collected tissue~     for research (biomarker) studies and banking for future studies.~   "
137104|NCT01260402|"~     Biventricular pacing is a validated treatment for patients suffering from heart failure~     resistant to medical treatment. However, up to 30% of the patients are non responsive to~     this strategy using the coronary sinus approach to pace the Left Ventricle (LV).~      It has been demonstrated that the magnitude of the improvement was highly dependant on the~     LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing~     sites. Resynchronisation using a transeptal approach to pace the left ventricle on the~     cardiology has been shown feasible on small series. We therefore would like to compare these~     two approached in a randomised prospective study to confirm the hypotheses that endocardial~     LV pacing by offering multiple choices for the pacing sites reduces the number of non~     responders and is associated with greater hemodynamic benefit when compared to the~     conventional coronary sinus approach.~   "
137105|NCT01260389|"~     This study would like to test the hypothesis that a pharmaceutical care intervention would~     result in an improved drug adherence and inhalation technique in Chronic Obstructive~     Pulmonary Disease (COPD) patients over a 3 month-period.~   "
137106|NCT01260376|"~     This study will investigate free fatty acid and VLDL-TG metabolism before and during~     exercise with and without pharmacological antilipolysis by the niacin antagonist Acipimox.~     Main focuses will be VLDL-TG and free fatty acid metabolism as well as expression of~     membrane proteins in fat- and muscle biopsies.~   "
137107|NCT01260363|"~     Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration~     analgesia with femoral nerve block after.~   "
137108|NCT01260350|"~     This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and~     without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in~     subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.~   "
137109|NCT01260337|"~     The purpose of this research study to find out whether a pre-packaged, portion controlled~     diet with a group behavior modification program or group diabetes support and education, is~     a safe and effective way for people with type 2 diabetes to lose weight and manage their~     diabetes.~   "
137110|NCT01260324|"~     The objectives of this study were to: (1) evaluate the natural history of non-arteritic~     anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION;~     and (3) identify potential risk factors for NAION.~   "
137111|NCT01260311|"~     This is an observational study and will determine the safety profile of fesoterodine in~     Filipino patients prescribed the drug. This is in compliance with the requirements of the~     Philippine Food and Drug Administration.~   "
137112|NCT01260298|"~     The objective of this study is to observe body contour changes following treatment using the~     MC1 device.~   "
137113|NCT01260285|"~     The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery~     patients.~   "
139048|NCT01234844|"~     In -patients in a geriatric rehabilitation unit, will participate in structured therapy with~     guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome~     of their rehabilitation.~   "
137115|NCT01260259|"~     Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved~     outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to~     elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory~     and cell survival pathways, and thus protect remote organs against future ischemic injury.~     We hypothesize that compared to sham treatment, RIPC will be associated with decreased~     post-operative acute kidney, myocardial, and lung injury.~   "
137116|NCT01260246|"~     This is a randomized, double-blind, placebo-controlled trial evaluating the impact of~     sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic~     steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of~     sitagliptin on other measures such as hormones modifying insulin release and sensitivity~     (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also~     be evaluated.~   "
137117|NCT01260233|"~     The purpose of this study is to determine whether a perioperative smoking cessation program,~     implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of~     smoking cessation or reduction. Intraoperative and immediate postoperative complications~     will also be compared.~   "
137118|NCT01260220|"~     An isolation-limited segmental antral approach to pulmonary vein isolation is as effective~     in achieving long-term freedom from atrial fibrillation as the standard anatomic,~     circumferential antral ablation.~   "
137119|NCT01260207|"~     The purpose of this study is to determine whether interactive voice response (IVR)~     technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer~     to best practice guidelines (BPGs).~      The study hypothesis is that ACS patients who are contacted by IVR technology will be more~     likely to receive care as recommended in the BPGs than those followed by usual care.~   "
137120|NCT01260194|"~     This open-label, multi-center study will evaluate the efficacy and safety of Herceptin~     (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients~     with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.~     Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin~     as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until~     disease progression.~   "
137121|NCT01260181|"~     This single arm, open-label study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with~     epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose~     of 150 mg orally daily until disease progression or unacceptable toxicity occurs.~   "
137122|NCT01260168|"~     The objective of this study is to confirm the sensitivity of a stool DNA test for detection~     of colorectal cancer and pre-cancer.~      Another objective is to provide anonymous, clinically characterized specimens for a~     bio-repository for future colorectal cancer-related test development.~   "
137123|NCT01260155|"~     This study will be a single-center, open-label, randomized, 3-treatment crossover~     bioavailability study of single oral doses of E5501 old tablet formulation under fasted~     conditions and a new tablet formulation administered under fed and fasted conditions in~     healthy subjects.~   "
137124|NCT01260142|"~     This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of~     fospropofol disodium in comparison to propofol. In addition, the study will compare the~     maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.~   "
137125|NCT01260129|"~     Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical~     study is designed to demonstrate that the newly adopted dose is not inferior to the existing~     dose in its efficacy and safety.~   "
137126|NCT01260116|"~     This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120~     schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental~     centers in China. Subjects will be required to attend the center at screening, baseline,~     Weeks 1, 2, 4 ,6 and 8 or early termination visit.~      At screening, patients underwent psychiatric and physical examination, standard lab tests,~     and an Electrocardiograph.~      At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.~      Depending on response and tolerability, ziprasidone could be gradually escalated to a~     maximum of 80 mg twice daily.~   "
137127|NCT01260103|"~     Primary Objectives~      To compare progression free survival (PFS), the time from randomization to progressive~     disease,in children with optic pathway glioma (OPG) age ≥ 6 months to < 18 years, who~     receive combination antineoplaston therapy (ANP therapy) vs. temozolomide (TMZ); study~     subjects will have 1) received prior treatment with carboplatin or cisplatin, which was~     terminated secondary to toxicity or progression of OPG, or 2) developed recurrence of OPG~     after completion of carboplatin or cisplatin therapy. PFS data will be censored on the date~     of the last tumor assessment documenting absence of progression for study subjects:~        -  Who are alive, on study and are progression-free at the time of the analysis;~        -  Who discontinue, receive no subsequent therapy and are progression-free at the time of~          the analysis;~        -  Who are given/change therapy other than the study treatment prior to observing~          progression;~        -  Who discontinued (due to personal preference or toxicity) with a change in therapy,~          withdrew, or was lost to follow-up;~        -  For whom documentation of disease progression or death occurs after ≥ 2 consecutive~          missed tumor assessments.~             -  To describe the toxicity profile for ANP therapy vs. TMZ.~      Secondary Objectives:~        -  To compare overall survival (OS) for subjects treated with ANP therapy vs. TMZ;~        -  To compare disease stabilization rates for subjects treated with ANP therapy vs. TMZ;~        -  To compare complete response (CR), partial response (PR), stable disease (SD), and~          progressive disease (PD) rates for subjects treated with ANP therapy vs. TMZ.~   "
137191|NCT01259258|"~     We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who~     received 2 ml intratunical space injection of methylene blue before spermatic vein ligation~     with 40 controls in whom no mapping technique was adopted in the period between January 2008~     and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were~     assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy,~     pain or other complications with mean follow up was 15+ 7months.~   "
137247|NCT01258530|"~     This is a study in healthy adult volunteers to assess the bioequivalence of~     over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both~     formulations will be administered in the fasting state.~   "
137128|NCT01260090|"~     Traumatic brain injury has a high morbidity and mortality in both civilian and military~     populations. Blast and other mechanisms of traumatic brain injury damage the brain by~     causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to~     persistently vegetative and minimally conscious states, for which extremely limited~     treatment options exist, including physical, occupational, speech and cognitive therapies.~      More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression.~     In addition to decreased seizure frequency and severity, patients report enhanced mood,~     reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and~     improved cognition, memory, and quality of life.~      The purpose of this study is to demonstrate objective improvement in clinical outcome by~     placement of a vagus nerve stimulator in patients who are recovering from severe traumatic~     brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased~     cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which~     promotes arousal and improved consciousness, thereby improving outcome after traumatic brain~     injury resulting in minimally conscious or persistent vegetative states. If this study~     demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a~     larger randomized prospective crossover trial will be proposed.~      The investigators will achieve this objective by evaluating whether vagus nerve stimulation~     impacts clinical recovery from minimally conscious or persistent vegetative states caused by~     traumatic brain injury as assessed by the FIM™ instrument and Functional Assessment Measure~     (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate~     whether vagus nerve stimulation alters resting and activational functional MRI.~      Twelve patients will be enrolled in this initial crossover pilot study. These patients will~     have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29)~     more than twelve months from starting the study, and have no other concurrent active severe~     medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior~     to left vagus nerve stimulation implantation. Patients will be randomized to alternating~     three month periods with the device on or off. Outcomes will be assessed at three month~     intervals with the FIM™ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma~     Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will~     also be assessed using quantitative eye movement tracking and functional magnetic resonance~     imaging. Patients will cross over every 3 months and be followed for at least 18 months.~   "
137129|NCT01260077|"~     Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time~     domain. A technique to evaluate this potential in the frequency domain could provide more~     information, but has only been applied within the last year. Design and Study Sample: In~     this study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears~     of 78 normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with~     intensity of 90 dB nHL. Next, the steady state vestibular evoked myogenic potential was~     recorded at the same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz.~     Results: The responses found by modulated frequency, regardless of carrier, recorded a~     higher presence of peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz.~     Conclusions: The results show that the observation technique in the frequency domain is~     feasible and shows a strong association with the time domain for recording vestibular evoked~     myogenic potentials, at carrying frequencies of 250, 500, 1000 or 2000 Hz.~   "
137130|NCT01260064|"~     1. Laparoscopic appendectomy may not be a superior procedure when compared with open~     appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the~     technical diffuculty and overall costs.~   "
137131|NCT01260051|"~     Currently, no clear consensus exists regarding the effect of epidural anesthesia upon~     breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate~     maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies~     have failed to separate these potential mechanisms. The present study examines whether~     epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and~     2) neonatal neurobehavioral deficits in feeding, as measured by the L&A components of the~     standardized, validated LATCH scoring system.~   "
137132|NCT01260038|"~     This is an observational study to evaluate the feasibility of the implementation of a~     personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the~     routine clinical care setting in the Antwerp region (Belgium).~   "
137133|NCT01260025|"~     1. MTD and DLT of M2ES~        2. Pharmacokinetics of M2ES~   "
137134|NCT01260012|"~     Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only~     limited proportion of subjects with infection develop this pathology and there is limited~     knowledge on risk factors for the differential morbidity patterns observed in endemic~     communities. Our preliminary cross-sectional study indicated that serum levels of~     antioxidants may be related with the development of fibrosis. The present project is a~     randomised double blinded placebo controlled prospective study investigating the role of~     food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with~     regards to the extent of fibrosis reversal.~   "
137135|NCT01259999|"~     Dietary intake in frail elderly is often lower than estimated needs due to the combined~     effects of the anorexia of ageing, frailty and the presence of acute and chronic disease.~     The objectives of the present study are to assess the effects of an oleic acid rich formula~     fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength~     and mobility. The investigators have recently performed a similar study in an acute ward~     setting without micronutrients.~   "
137136|NCT01259986|"~     The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible~     light laser in the treatment of various recalcitrant forms of vitiligo.~   "
137137|NCT01259973|"~     The purpose of this study is to determine in healthy volunteers treated with typical or~     atypical antipsychotics -AP-, the relationship between genetic polymorphisms in cytochrome~     genes CYP2D6 (*3, *4, *5, *6 and Nxn) and CYP3A5 (*3) with antipsychotic pharmacokinetics,~     occupancy of striatal dopaminergic receptors and the appearance of extrapyramidal~     symptomatology -EPS-.~   "
137138|NCT01259960|"~     Being confronted more and more with obese as well as older patients, minimally invasive~     surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the~     continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and~     analyzing the effect of body mass index (BMI) and wound healing.~   "
137192|NCT01259245|"~     The purpose of this study was to compare the self-efficacy and quality of life parameters of~     Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation~     with and without Tai Chi elements incorporated in the exercise component in a General~     Out-patient setting.~   "
137193|NCT01259232|"~     To investigate the brain abnormalities and the association with gene in schizophrenia~     patients and their relatives.~   "
137194|NCT01259219|"~     Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected~     children receiving a LPV/RTV-based ART regimen and who have a recent history of completing~     TB treatment.~   "
137195|NCT01259206|"~     Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate~     from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by~     decreased ability of tissue repair and increased reactive ossification. Thus, the~     investigators aimed to determine CS incidence in asymptomatic obese subjects with and~     without type 2 diabetes mellitus (T2DM).~   "
137139|NCT01259947|"~     Abstract Background: There is no universally accepted and effective prophylaxis of migraine~     headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba~     (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency~     and intensity of migraine patients.~      Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to~     orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity~     and frequency of episodes were recorded before and after 30-60 days of treatment. The~     investigators also studied the chemical composition of its essential oil by gas~     chromatography-mass spectrometry.~      Results: The investigators described for the first time a particular L. alba chemotype with~     geranial and carvenone as major compounds. With treatment, both frequency and intensity of~     pain episodes significantly decreased from baseline to first reassessment date. More than~     80% of patients experienced a minimum 50% reduction on pain intensity and frequency. No side~     effects were reported.~      Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract~     is a cheap, widely available, highly effective therapy to reduce both the intensity and the~     frequency of headache episodes of migraine patients with no side effects.~      Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy~   "
137140|NCT01259934|"~     The aim of this study is to evaluate the effect of giving adjuvant treatment with~     intermediate doses of interferon-alpha2b to patients operated for high risk melanoma.~     Patients are randomly assigned to either observation only or interferon treatment for 2~     different durations. The outcome with respect to overall survival, relapse-free survival,~     side effects and quality of life is analysed.~   "
137141|NCT01259921|"~     The purpose of this study is to determine whether neurofeedback (NF) training can~     significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals~     with significant affect dysregulation and chronic, treatment-resistant PTSD. The primary~     aims of this study include:~        1. To examine whether NF has the potential to significantly reduce symptoms of PTSD.~        2. To examine whether NF training can specifically target the area of affect regulation.~        3. To examine the mechanism of NF through elucidating the relationship between affect~          regulation and PTSD symptom change.~   "
137142|NCT01259908|"~     Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally~     laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will~     be followed up and the results will be compared between the two procedures on the basis of~     the primary endpoint, a composite endpoint defined as a combined incidence of systemic~     morbidity, graft thrombosis and all-cause mortality.~   "
137143|NCT01259895|"~     The purpose of this study is to determine the effect of different time of sleep restriction~     on control of food intake and metabolism of obese and normal subjects.~   "
137144|NCT01259882|"~     This is a two part study. The purpose of the first part is primarily to determine the safety~     and toleration and pharmacokinetics of PF-05089771 following single escalating doses.~     Secondary objectives will be to investigate the PK of an alternative formulation of~     PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study~     will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel~     biomarkers in healthy volunteers. The doses selected in Part B will have been administered~     previously in Part A of the study.~   "
137145|NCT01259869|"~     The purpose of this study is to find out whether the new drug PX-866 will slow the growth of~     your glioblastoma multiforme.~   "
137146|NCT01259856|"~     This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia~     Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes~     too many platelets and red blood cells to be made. Platelets are particles which circulate~     in the blood stream and normally prevent bleeding and bruising. Having too many platelets in~     the blood increases the risk of developing blood clots, which can result in life threatening~     events like heart attacks and strokes. When the number of red blood cells is increased in PV~     this will slow the speed of blood flow in the body and increases the risk of developing~     blood clots.~      The purpose of this study is to look at the effectiveness of giving participants who have~     been diagnosed with ET or PV one of two different study regimens over time. The study~     subject will be followed for their condition for about 5 years. The subject will be~     randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or~     Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed~     or already receiving treatment for either PV or ET. Each of the study drugs used in this~     study is already being used to treat subjects with ET or PV currently, but the investigators~     are unsure which study drug is better.~   "
137147|NCT01259843|"~     The study examined the clinical characteristics and conditions of care for patients with~     acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and~     mortality and provide a basis for the eventual achievement of specific studies on the~     optimal therapeutic management according to different risk profiles. The aim of the~     Observatory is to provide a photograph size of practices in France at present, both in the~     larger centers than in smaller and optimize diagnostic and therapeutic currently available~     by the activation pathways of rational management.~   "
137148|NCT01259830|"~     Post-operative pain after laparoscopic colon and rectal surgery in fast-track design.~      A fast-track program is an evidence-based, multimodal approach for patients undergoing~     surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient~     centered well-being. Optimized pain relief is a core component of any fast-track regimen.~      In this context epidural analgesia has become the standard of care for early postoperative~     pain therapy.~      However, it is debated whether non-opioid analgesics should be given as adjuncts when~     epidural analgesia is already present.~      The purpose of this study is to demonstrate that the administration of etoricoxib 120mg~     additionally to the clinical routine therapy (epidural catheter) reduces the post-operative~     pain level during movement after laparoscopic colon surgery in the fast-track design.~   "
137196|NCT01259193|"~     Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with~     antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.~      Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer.~     Emerging data suggest that zoledronic acid may also exhibit anticancer properties.~      The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic~     Acid and to evaluate overall survival and time to progression.~   "
137149|NCT01259817|"~     The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and~     Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets~     and PV causes too many platelets and red blood cells to be made. Platelets are particles~     which circulate in the blood stream and normally prevent bleeding and bruising. Having too~     many platelets in the blood increases the risk of developing blood clots, which can result~     in life threatening events like heart attacks and strokes. When the number of red blood~     cells is increased in PV this will slow the speed of blood flow in the body and increases~     the risk of developing blood clots.~      It is important for patients with ET or PV who are at risk of blood clots to receive drugs~     which will minimize the risks of developing these blood clots but at the moment the~     investigators are not sure which drugs will best control the disorder.~      The purpose of this study is to look at the effectiveness of giving patients who have been~     diagnosed with ET and PV a study drug regimen using Aspirin and PEGASYS (also known as~     Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea (or~     hydroxycarbamide or Hydroxyurea), for whom this drug may not be suitable. The drug may not~     be suitable either because it is not adequately controlling the number of blood cells or~     some specific side effects occur.~   "
137150|NCT01259804|"~     Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy~   "
137151|NCT01259791|"~     This study consists of a series of prospective, randomized placebo-controlled n of 1 trials~     to objectively evaluate the reproducibility of subjective and objective symptoms among~     patients with a history of statin-related myopathy.~   "
137152|NCT01259778|"~     This is a National, Multicentre, Observational Registry to study Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for~     growth hormone treatment from hospital in Korea in order to assess the level of adherence of~     subjects receiving SAIZEN® via easypod™.~   "
137153|NCT01259765|"~     The investigators hypothesize that :~      oral administration of VHH batch 203027 will be~        -  safe and tolerable for healthy Bangladeshi humans of all age groups (Part I)~        -  effective in reducing severity of diarrhoea in children with proven rotavirus infection~          (Part II). This entry only covers Part II.~   "
137154|NCT01259752|"~     This is a multicenter prospective randomized superiority controlled trial comparing leg~     stockings and standard care to standard care of ankle sprain and testing the hypothesis that~     compression stockings enable to reduce the median of recovery from ankle sprain by at least~     6 days.~   "
137155|NCT01259739|"~     The purpose of this study is to characterize the potential improvement of cocoa flavanols on~     exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized~     control study will be performed in 13 highly trained cyclist (crossover design).~     Participants will perform a baseline exercise testing on an ergometer. They will receive~     either a flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second~     and third exercise testing is performed. The order of drinks is randomized and balanced~     (high-flavanol-->low-flavanol drink or low-flavanol drink-->high-flavanol drink)~   "
137156|NCT01259726|"~     The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621~     dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the~     frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3)~     to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a~     dose regimen of VP 20621 to be used in future studies.~   "
137157|NCT01259713|"~     The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®)~     can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute~     Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.~   "
137158|NCT01259700|"~     Cardiovascular disease is the leading cause of death in China. At the village level,~     strategies for the control of cardiovascular disease are mostly absent. National clinical~     guidelines for the management of hypertension and cardiovascular disease are rarely~     disseminated to, or implemented by, the village primary care providers. Salt reduction has~     greater potential in rural China than almost anywhere else in the world. Very high levels of~     salt consumption, very little use of processed food and most dietary salt deriving from home~     cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in~     almost any other setting. The two large-scale cluster-randomized controlled trials proposed~     here will precisely and reliably define the effect of two highly plausible intervention~     strategies on important clinical outcomes. The evidence provided by the project will form~     the basis for policy setting that has the potential to greatly reduce the occurrence of~     vascular disease in rural China and take an important step towards balancing the rural urban~     divide in health and healthcare.~   "
137159|NCT01259687|"~     Pulse transit time (PuTT) - the time between R wave on ECG and initiation of upstroke in the~     peripheral arterial waveform - described in the previous studies as value that reflects~     changes in both blood pressure and blood volume. The investigators are assuming that PuTT~     changes reflect the dynamic of systolic blood pressure but not cardiac output fluctuations.~   "
137160|NCT01259674|"~     The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute~     cough as compared to a placebo syrup.~   "
137175|NCT01259479|"~     Background:~        -  Cisplatin and carboplatin are standard cancer treatment drugs used for various~          childhood cancers, including brain tumors. Both drugs frequently have severe side~          effects that may reduce their effectiveness, particularly in children, and new~          treatments are needed that may be similarly effective but less toxic for cancer~          patients.~        -  Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not~          yet been approved by the Food and Drug Administration. Satraplatin has been shown to~          treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults~          with cancer who have received satraplatin had slowing of the growth or shrinkage of~          their tumor. Researchers are interested in determining whether satraplatin can be~          effective for cancers that occur in children.~      Objectives:~        -  To evaluate the safety and effectiveness of satraplatin as a treatment for children and~          young adults who have solid tumors that have not responded to standard treatment.~        -  To study the effects of satraplatin on the body in terms of side effects and blood~          chemistry.~        -  To examine the effect that genetic variations may have on the effectiveness of~          satraplatin.~      Eligibility:~      - Children, adolescents, and young adults between 3 and 21 years of age who have solid~     tumors (including brain tumors) that have not responded to standard treatment.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood tests, and tumor imaging studies.~        -  Participants will receive satraplatin pills to be taken every day in the morning for 5~          consecutive days, with no food for 2 hours before or 1 hour after the dose.~          Participants will then have 23 days without the drug to complete a 28-day cycle of~          treatment. Participants will also receive medication to prevent nausea and vomiting 30~          minutes before the first dose of satraplatin. Following the first dose of satraplatin,~          medication for nausea will be given if needed.~        -  Satraplatin doses will be adjusted based on response to treatment, including potential~          side effects. Participants will have frequent blood tests and imaging studies to~          evaluate the effectiveness of the treatment and monitor any side effects, as well as~          hearing tests and other examinations as required by the study researchers.~        -  Participants will receive satraplatin every 4 weeks for up to 2 years until serious~          side effects occur or the tumor stops responding to treatment.~   "
137161|NCT01259661|"~     Hormonal changes associated with menopause, chronological aging, and lifestyle, especially~     physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women.~     Women exhibiting the metabolic syndrome have multiple coronary artery disease risk~     factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be~     conducted to test the hypotheses: (1) physical activity and physical fitness levels may have~     effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2)~     endurance exercise training may have a favorable effect on components of the metabolic risk~     variables in these women.~      In this study, the associations among physical activity (including daily energy expenditure~     and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level,~     and metabolic risk profile of the women will be assessed. The investigators will perform a~     randomized trial to compare the effects of moderate-intensity aerobic exercise training~     regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk~     factor for metabolic syndrome will be randomized in the exercise group or control groups.~     Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood~     pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of~     the study. Differences from baseline to follow-up will be calculated and compared across~     groups.~      Results of this study may help health care providers providing advice to postmenopausal~     women for life style changes to reduce risk of insulin resistance, coronary heart disease,~     and diabetes.~   "
137162|NCT01259648|"~     The primary objective is to determine whether, during a rapid sequence intubation by~     etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2~     different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous~     reactional tachycardia.~   "
137163|NCT01259635|"~     The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and~     after 6 weeks of training. Two types of interventions (20 subjects in each group) will be~     tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG~     training includes walking courses aimed at provoking freezing episodes. The experimenter~     will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke~     freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the~     auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid~     freezing. Similar principles will apply for the CLG training; however, the RAS will be~     elicited automatically by a device that recognizes an approaching freezing episode.~   "
137164|NCT01259622|"~     The purpose of this study is to evaluate the effects of a single intravenous infusion of~     K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm,~     reduction of subject's symptom score, and safety.~   "
137165|NCT01259609|"~     The purpose of this study is to determine whether ciliary body thickness increased in the~     presence of diabetic macular edema and whether it changed after pars plana vitrectomy.~   "
137166|NCT01259596|"~     The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and~     supportive therapy delivered by telephone are effective for reducing worry and anxiety in~     rural older adults with Generalized Anxiety Disorder (GAD).~   "
137167|NCT01259583|"~     Due to the increasing demand for colonoscopy in clinical practice, great interest has~     recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm~     Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as~     compared to standard Air Insufflation (AI). This study is aimed at evaluating the~     performance of the above techniques versus AI in unsedated patients.~   "
137168|NCT01259570|"~     The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in~     absence of fat.~      As a model the investigators have chosen nonfat yoghurt. The investigators will prepare~     yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ;~     (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into~     skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched~     skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr~     yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by~     CMIA. In vitro simulated digestion will be studied.~      Expected results: The BA of VD in CM would not be lower than in fat~   "
137169|NCT01259557|"~     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the~     treatment of Essential blepharospasm.~   "
137170|NCT01259544|"~     13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine~     function in patients with Chronic Pancreatitis.~   "
137171|NCT01259531|"~     This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12~     week treatment of patients with severe urinary disorders associated with benign prostatic~     hyperplasia (BPH).~   "
137172|NCT01259518|"~     This is an open-label, parallel-group, two-center, safety, activity and pharmacokinetic~     study of TriN 2755 given at increasing dose levels as intravenous infusions administered~     over 4 hours. The study is divided into two parts: Part I a dose escalation phase and Part~     II an extension phase.~   "
137173|NCT01259505|"~     The purpose of this study is to evaluate the safety of HLA-A*2402 restricted epitope~     peptides CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.~   "
137174|NCT01259492|"~     This study will evaluate efficacy and safety of methylphenidate hydrochloride extended~     release compared to placebo in adult patients with childhood-onset attention~     deficit/hyperactivity disorder (ADHD).~   "
137189|NCT01259297|"~     This study was planned to provide new information regarding the role of aliskiren (with or~     without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly~     individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing~     major cardiovascular (CV) events and on global measures of physical, executive and cognitive~     function.~   "
137190|NCT01259284|"~     The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil~     supplements can help to control side effects of the heart that are commonly seen after lung~     surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs~     is more effective than the other at controlling side effects.~   "
137197|NCT01259180|"~     The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain~     in women with endometriosis or adenomyosis.~   "
137176|NCT01259466|"~     This project will be a randomized clinical trial testing the efficacy of an~     internet-administered smoking cessation treatment for overweight and obese smokers. Research~     on internet-administered behavioral treatments for smoking cessation has found that compared~     to control treatments (e.g., self-help materials), cessation rates in internet-administered~     treatments are significantly higher. Research testing the applicability of these treatments~     to overweight and obese individuals has not yet been conducted. Given that a substantial~     portion of smokers are also overweight and at elevated cardiovascular risk, there is a need~     for directed treatment efforts for this group. The current trial proposes to be the first to~     test the effectiveness of internet-administered smoking cessation treatment for overweight~     and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of~     internet-administered treatment consisting of either: a) standard smoking cessation~     treatment with general health education, or b) standard smoking cessation treatment with~     cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will~     receive open-label treatment with the 21 mg transdermal nicotine patch.~   "
137177|NCT01259453|"~     The investigators seek to provide immunization for individuals who are at high risk of~     contracting hepatitis B virus (HBV) infection because of their illicit drug use. The~     investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport,~     CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The~     primary purpose of the study is to compare the standard schedule of hepatitis B vaccination~     at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The~     investigators hypothesize that the accelerated scheduling will result in improved completion~     rates without significant loss in vaccine efficacy.~   "
137178|NCT01259440|"~     Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk~     factors of male gender, being overweight, and increasing age. OSA is caused by upper airway~     obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway~     pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is~     suboptimal. Because research shows that adherence patterns are established early in~     treatment, we seek to use a technology that enables early and frequent productive~     interactions between patient and provider.~   "
137179|NCT01259427|"~     The purpose of this study is to determine if Ending Self-Stigma (ESS), a 9-session group~     intervention designed to assist veterans with serious mental illness to develop skills (SMI)~     to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and~     stereotypes, is more effective in reducing internalized stigma and its associated effects~     than an active comparison group.~   "
137180|NCT01259414|"~     TACE is considered the standard treatment for unresectable HCC and is widely used as a~     palliative treatment. However there is no consensus of the protocol of TACE.One of the~     variation is does the stability of the suspension by emulsified the lipiodol and the~     contrast medium used to dissolve the anticancer agents really effect the survival.Thus the~     investigators conduct this prospective,randomized controlled study to find out if the~     different method of preparing chemotheraputic drugs can cause a different survival benefit.~   "
137181|NCT01259401|"~     The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the~     Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans.~     Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services.~     Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive~     problems and low quality of life. These factors can lead to continued deterioration in~     functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep~     disruption is associated with depression, low quality of life, functional decline, nursing~     home placement, and death among older people. Sleep disturbance is common among ADHC~     patients, it is not addressed within routine clinical care, and treatment may be limited to~     medications. Studies show that untreated insomnia and medications for insomnia can increase~     risk of falls and other health events among older persons. On the other hand, non-medication~     treatments for sleep do not show these problems. These treatments have been shown to be~     effective in other studies. The goal of this study is to test non-medication treatments to~     improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will~     facilitate translation into routine care and application in other similar VA programs.~   "
137182|NCT01259388|"~     The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,~     and effective at treating progressive forms of multiple sclerosis.~   "
137183|NCT01259375|"~     Primary Objectives~        1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or~          advanced sarcoma as first line therapy.~        2. To evaluate Progression Free Survival (PFS).~      Secondary Objectives~        1. To assess the safety and tolerability of amrubicin in this patient population.~        2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential~          response to amrubicin.~        3. To investigate quality of response with radiographic evaluation using both Response~          Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.~        4. To evaluate overall survival (OS).~   "
137184|NCT01259362|"~     Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing~     craving and extending the abstinence period of this patients during treatment.~      The aim of this study is to evaluate reduction if craving and other parameters related to~     addiction within this group of patients through a treatment with transcranial magnetic~     stimulation.~   "
137185|NCT01259349|"~     Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard~     coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract~     in terms of corneal endothelial safety.~   "
137186|NCT01259336|"~     The purpose of this study is to determine whether there itraconazole is effective in the~     treatment of chronic cavitary pulmonary aspergillosis~   "
137187|NCT01259323|"~     The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body~     reacts to the drug) compared to placebo (an inert substance) in patients with~     moderate-to-severe extrinsic Atopic Dermatitis.~   "
137188|NCT01259310|"~     This is a three-center prospective case-control study to examine the patterns of fertility~     among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy~     (WWoE).~   "
137206|NCT01259063|"~     The purpose of this study is to test the safety of gemcitabine applied to the bladder~     directly combined with different oral doses of everolimus and to assess the right doses.~     Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be~     evaluated. The purpose of the phase II part is to test the combination of gemcitabine~     applied to the bladder directly combined with different oral doses of everolimus and to~     study the effects of these two drugs together. The investigators want to find out what~     effects, good and/or bad, this treatment has on the patient and the cancer.~   "
137207|NCT01259050|"~     The purpose of this study is to determine the safety of Zinc given at 90mg/d in conjunction~     with 2mg/d of copper in ALS patients.~   "
137208|NCT01259037|"~     This study will look at high frequency ultrasound as a medical imaging modality and apply it~     to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area.~     We will use this to try and differentiate between benign and cancerous skin lesions.~   "
137209|NCT01259024|"~     This study involves the combined use of the FDA approved device, LC Bead and the FDA~     approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The~     current indication of the LC Bead is for the embolization of hypervascular tumors and~     arteriovenous malformations. The study is designed to establish if drug eluting beads are~     more effective and less toxic than standard chemoembolization treatment.~   "
137210|NCT01259011|"~     The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness~     Representations to Increase Trust) intervention designed to improve discussions about~     end-of-life care between patients and their surrogate decision makers. Subjects will be 200~     Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from~     outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that~     (1) SPIRIT will lead to significantly less patient decisional conflict and significantly~     greater dyad congruence and surrogate decision making confidence than the standard care~     control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate~     decisional conflict and psychosocial morbidities at 2 weeks after the patient's~     hospitalization requiring surrogate decision making significantly more than the standard~     care control.~   "
137211|NCT01258998|"~     This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating~     patients with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
137212|NCT01258985|"~     We will conduct a large randomized controlled trial comparing the effectiveness and~     cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for~     Knee Osteoarthritis.~   "
137213|NCT01258972|"~     The Tryton Side Branch Stent System has been designed to address the procedural difficulty~     surrounding treatment of bifurcation lesions and to ensure patency of the side branch with~     similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength)~     that are currently available with conventional coronary stents designed for straight (non~     bifurcation) lesions.~      The Tryton Side Branch Stent is intended to treat and maintain patency in the side~     branch/carina by providing better ostial side branch conformability and is intended for use~     in conjunction with currently approved balloon-expandable drug-eluding stents for treatment~     of the main branch.~   "
137214|NCT01258959|"~     Ophthalmic surgery on the posterior section of the eye can either be performed under general~     anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting~     local anaesthetics behind the eye. There are two techniques: Either the needle is placed~     into the muscle cone formed by the four recti muscles - this is called intraconal or~     retrobulbar block, or the needle is placed outside of the muscle cone - this would be called~     extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar~     block since it is easier to perform and has a smaller risk to injure the eye. The~     investigators however realize that the parabulbar block is sometimes very efficient and~     sometimes not, thus requiring a second or third injection. Now investigators are able to~     visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim~     of the study is to observe and to describe the incidence of intraconal spread of local~     anaesthetics when a peribulbar block is performed.~   "
137215|NCT01258946|"~     The aim of the present study was to search whether epicardial adipose tissue thickness, a~     predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it~     does, to analyze the relationship of EATT with insulin resistance, adiponectin and~     biochemical and anthropometric parameters.~   "
137216|NCT01258933|"~     The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL~     that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be~     studied.~   "
137217|NCT01258920|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this~     study are to: explore the efficacy on symptoms of schizophrenia and the maintenance of~     treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse~     pharmacokinetic sampling.~   "
137218|NCT01258907|"~     This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized,~     multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care~     therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation,~     as quantified by FDG-PET/CT.~   "
137219|NCT01258894|"~     Studies revealed that patients with hereditary persistence of AFP also had persistent~     abnormal AFP. Therefore, this study will recruit the patients and their family with elevated~     AFP (>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes~     extracted from the blood will be analyzed.~   "
137220|NCT01258881|"~     Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate~     among the gynecologic malignancies. The majority of patients with epithelial ovarian~     carcinoma are diagnosed at advanced stage which has the overall survival rates of only~     19-30%. As the advance in the managements which prolonged the overall survival, metastatic~     lesion in rare location such as brain was noted in few patients of ovarian cancer in recent~     years. In the retrospective study, the investigators will review the medical records of the~     ovarian cancer patients with brain metastasis in the investigators hospital to investigate~     the incidence, clinical courses, optimal managements and possible prognostic factors in the~     rare condition.~   "
137221|NCT01258868|"~     Background:~      - Recent research has shown that causing an immune response to tumor cells may help slow or~     stop the growth of tumors. One treatment that has come from this research involves~     collecting and modifying a cancer patient's tumor cells in the laboratory, then returning~     the cells to the patient as a vaccine to encourage the immune system to respond to them.~     Researchers are interested in testing tumor cell vaccines with an experimental drug called~     ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response~     in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is~     still experimental, though it has been tested and used safely in other clinical studies.~     Researchers are also interested in determining whether the anti-inflammatory drug celecoxib~     will improve the body's immune reaction if given with the vaccine.~      Objectives:~      - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and~     celecoxib in the treatment of lung and esophagus cancers.~      Eligibility:~        -  Individuals at least 18 years of age who have primary small cell or non-small cell lung~          cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.~        -  Only individuals whose tumor cells are able to produce a tumor cell line for vaccine~          development will be eligible for treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          have tumor tissue collected during their surgery to determine whether the tumor cells~          can be used to produce a vaccine.~        -  Participants will take celecoxib twice daily for 7 days before having the first tumor~          cell vaccination. Participants will also have leukapheresis to collect blood cells for~          testing before the first vaccination.~        -  Participants will receive one vaccine (which may be given in two shots) monthly for 6~          months, and will continue to take celecoxib twice daily. One month after the 6th~          vaccine shot, participants will have another leukapheresis and skin test. If these~          tests show that a participant is responding to the vaccine, additional vaccines will be~          given every 3 months for up to 2 years.~        -  Participants will have a physical exam and lab tests before each vaccination, blood~          samples and imaging studies every 3 months, and a skin test every 6 months.~        -  Participants will have regular followup visits with imaging studies and blood samples~          for up to 5 years after the first vaccination, or until a new tumor develops....~   "
137222|NCT01258855|"~     This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept~     works in treating patients with stage III-IV melanoma that cannot be removed by surgery.~     Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the~     growth of melanoma by blocking blood flow to the tumor. It is not yet known whether~     aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.~   "
137223|NCT01258842|"~     To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of~     developing physician- and laboratory-confirmed influenza infection at any time during the~     12-week supplementation period.~   "
137224|NCT01258829|"~     Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for~     heart failure do not have the settings of their device optimised. The most widely available~     method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to~     determine the optimal settings. However, this is not frequently performed because it is time~     consuming and requires two skilled operators. In this study the investigators will test a~     new non-invasive method for optimisation, which utilises pressure measurements (non-invasive~     blood pressure measured from the finger).~      Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms~     of exercise capacity, to conventional echo optimisation.~   "
137225|NCT01258816|"~     The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties~     of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The~     efficacy and tolerability of elacytarabine will also be assessed.~   "
137226|NCT01258803|"~     A study to compare the bronchodilatory effect of a single dose of Mometasone~     Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and~     without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer)~     versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder~     inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each~     participant was to receive a single dose of each of 4 treatments in each period. Each~     treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose~     MF/F MDI 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation,~     defined as a significant increase in forced expiratory volume in one second (FEV1) area~     under the curve from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.~   "
137227|NCT01258790|"~     Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta~     Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects~      Hypothesis1: cTBS, compared to sham stimulation, will reduce tic severity by at least 25% as~     measured by the Yale Global Tic Severity Scale~      Specific Aim2: Using cTBS to further understand neural correlates of tic generation~      Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this~     change will correlate with clinical improvement in tic severity~   "
137228|NCT01258777|"~     The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and~     Caucasian Males.~   "
137229|NCT01258764|"~     The purpose of this trial is to evaluate if an objective clinical decision of~     anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.~   "
137230|NCT01258751|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-05212377 in healthy volunteers~   "
137231|NCT01258738|"~     This is a two part study. During period one there will be a comparison of Etanercept (ETN)~     against a placebo with both arms maintaining the background anti inflammatory drug~     prescribed by their Physician. The hypothesis is that Etanercept will be superior to the~     placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing~     Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension~     where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti~     inflammatory drug(NSAID).~   "
137232|NCT01258725|"~     The aim of this study is to compare the uteroplacental and pulmonary circulation of the~     fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in~     normal controls. Further purpose of the study is to measure the changes of the~     uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic~     oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.~   "
137233|NCT01258712|"~     This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with~     Rheumatoid Arthritis.~   "
137234|NCT01258699|"~     This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab~     600mg in Healthy Adult Male Subjects.~   "
137235|NCT01258686|"~     The purpose of this study is to determine the effectiveness of silymarin 700 mg thrice daily~     and assess the safety in patients with hepatitis C virus infection compared to a placebo.~   "
137236|NCT01258673|"~     The purpose of this study is to evaluate the antihypertensive efficacy and safety of~     Fimasartan/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential~     hypertension who are not controlled by fimasartan 60mg.~   "
137237|NCT01258660|"~     The purpose of this study is to examine and compare the uptake of levomefolate calcium~     (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of~     treatment with a following folate elimination phase of 20 weeks in healthy volunteers~     seeking contraception. Yasmin (oral contraceptive containing drospirenone and~     ethinylestradiol) was co-administered over the entire period of 44 weeks.~   "
137238|NCT01258647|"~     Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer~     from stunting of linear growth by 12 months of age. Stunting presumably results from breast~     milk supplementation after 6 months of age with complementary foods (CF) that provide~     inadequate protein and micronutrients. Although supplementation with selected micronutrients~     may avoid certain deficiency states, CF with animal source foods may be necessary to avoid~     stunting. Meat is not readily available in many Central African countries. However~     caterpillars, which are locally available and abundant, are a common staple in adult diets~     and may be a suitable substitute for animal source proteins in CF. The investigators~     developed a cereal made from dried caterpillars that has a nutrient content that appears to~     be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their~     8 month old infants. The investigators hypothesize that this cereal will be accepted by both~     mothers and infants: acceptability will be based on a priori definitions.~   "
137239|NCT01258634|"~     This is a pilot study that will allow investigators to collect data related to early and~     potentially more accurate response assessments using a chemotherapy protocol that eliminates~     methotrexate to maximize the dose intensity of doxorubicin. The pilot data will be used to~     seek funding to more fully address the hypotheses in a multi-institutional, Phase II or~     Phase III trial. The primary and secondary objectives are as follows:~      Primary:~        1. To evaluate the feasibility and potential usefulness of measuring early changes in~          tumor metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography~          (FDG-PET) imaging and alkaline phosphatase activity, as early predictors of~          histological response rate at 12 weeks in osteosarcoma patients.~        2. To explore whether histological response can be assessed by a computer algorithm using~          virtual microscopic images of pathology material, and whether quantifying necrosis in~          this way correlates with microscope slide-based review.~      Secondary:~      1. To gather pilot data on the histological response rate, 3-year event-free survival, and~     toxicity when children and young adults with resectable osteosarcoma are treated using a~     chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and~     doxorubicin/ifosfamide/etoposide (IDE).~      All patients will receive 4 courses of preoperative chemotherapy courses. With the exception~     of high-dose methotrexate, which is given weekly, preoperative and postoperative~     chemotherapy courses are planned to begin every 21 days.~      Patients with good histological response (those patients with > 90% tumor necrosis at time~     of definitive resection) will receive three postoperative chemotherapy courses. The 1st will~     consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor~     (G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin,~     dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will~     consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin~     dose will be 450 mg/m2.~      Patients with poor response (those patients with < 90% tumor necrosis found on pathology at~     time of definitive resection) will receive five postoperative chemotherapy courses. High~     Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy~     courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of~     doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will~     consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or~     PEG-filgrastim). The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or~     PEG-filgrastrim). The total doxorubicin dose will be 450 mg/m2.~   "
137240|NCT01258621|"~     Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has~     recently becoming the treatment of choice in experienced centres. No data have been~     published about learning curve so far. The purpose of this study was to identify the~     learning curve period for performing LDP.~   "
137241|NCT01258608|"~     Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death~     pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a~     multikinase inhibitor, is the standard of care for treatment of patients with advanced~     hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest~     that these agents could interact synergistically. This is a Phase 2, multi-center,~     randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of~     mapatumumab in combination with sorafenib in subjects with advanced hepatocellular~     carcinoma.~   "
137242|NCT01258595|"~     The aim of the study is to generate data on key parameters associated with assessment of~     influenza vaccines in individuals 50-64 years of age~      Primary Objective:~        -  To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine~          (TIV) compared to TIV.~        -  To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as~          assessed by solicited adverse reactions collected for 7 days post-vaccination, and~          unsolicited adverse events (including Serious Adverse Events and Adverse Events of~          Special Interests) collected between Visit 1 and Visit 2~   "
137243|NCT01258582|"~     This study was initially designed to compare the effectiveness of two different approaches~     to providing routine HIV counseling, testing, and referral services in an urban hospital~     emergency department setting. The initial phase was closed in July 2008. The second phase of~     this trial consists of establishing the differences in acceptability of HIV testing based on~     the method of testing offered (rapid oral fluid vs. fingerstick).~   "
137244|NCT01258569|"~     Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been~     shown to increase postoperative bowel function in patients after open bowel resection~     surgery. It has been proven safe and effective for short-term in-house treatment. At the~     present there are several Drug Use Utilization Evaluation studies reporting results~     involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However,~     this study will be the first randomized, prospective, double-blind, placebo-controlled trial~     looking at this population. We propose that Entereg will decrease the length of stay by one~     day in the laparoscopic colon resection patient. We wish to perform a voluntary,~     double-blinded, placebo controlled study. We plan an enrollment population of 250 patients.~     Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by~     12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length~     of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and~     time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be~     secondary endpoints.~      Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion~     Date: May 2012, Estimated Primary Completion Date: Nov 2011.~   "
137245|NCT01258556|"~     Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented~     with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women~     living with HIV.~   "
137246|NCT01258543|"~     The purpose of this study is to determine whether two osteopathic evaluators with less than~     5 years experience will be able to determine the same location and nature of the primary~     lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global~     osteopathic evaluation approach.~   "
137249|NCT01258504|"~     The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9)~     genotype (*2 and *3 allele versus wild type; ~3-5% poor metabolisers in Caucasian~     population) on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St.~     John's wort (SJW) on steady state bosentan which is a CYP3A4 inducer itself.~   "
137250|NCT01258491|"~     The study will be a double-blind, randomized, placebo-controlled, single-center, 2~     treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a~     single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be~     randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:~        -  Treatment A: 500 mg nicotinic acid~        -  Treatment B: Placebo~   "
137251|NCT01258478|"~     Patients suffering from non small cell lung cancer(NSCLC), depend upon lung removal to~     increase their chances of survival. But, this type of surgery cannot be advised to patients~     with significant heart disease, limited lung fuction or reduced physical fitness. Intensive~     physical training has been shown to increase aerobic fitness in healthy subjects.~      The purpose of this study is to determine the effect of a short term rehabilitation prior to~     surgery on the post-operative and physiological outcomes for patients undergoing this type~     of surgery.~   "
137252|NCT01258465|"~     The purpose of this research project was to systematically compare two widely used types of~     intervention programs for children with autism within a parent training model. In one~     condition, randomly assigned children were provided with an intervention that typically~     results in acquisition of expressive words in a large percentage of children diagnosed as~     having autism, using a well-documented manualized intervention focused on verbal expressive~     communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly~     assigned children received a widely used intervention on the same social communication~     functions using a well-documented manualized augmentative system of intervention (Picture~     Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal~     communication in large percentages of children diagnosed with autism. Children in the two~     conditions were compared for development of verbal and nonverbal communication, changes in~     disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In~     addition, parent satisfaction and stress measures were gathered in order to assess the~     effects of each intervention on family functioning.~   "
137253|NCT01258452|"~     To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption~     of CHF 5074 after single oral administration in young healthy male volunteers.~   "
137254|NCT01258439|"~     This is a research study into the effects of three drugs used to treat HIV infection. Some~     drugs used to treat HIV have been associated with changes in blood fats such as cholesterol~     that could be harmful over the long-term, because these blood fat changes have been~     associated with a small, increased risk of heart disease and stroke in some studies of~     adults with HIV. Now that HIV can be controlled for long periods in most patients, and~     because heart disease is one of the biggest causes of illness and death in the general~     population, it is important to develop new HIV treatments that control HIV effectively but~     do not cause abnormal blood fats.~      Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than~     ritonavir-boosted darunavir.~   "
137255|NCT01257204|"~     To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of~     daclatasvir with pegylated interferon alfa-2a and ribavirin.~   "
137256|NCT01257191|"~     The goal of this study is to see how the type and size of particles found in air pollution~     affects inflammation in the nose in people who are skin test positive to at least one~     allergen. It has been observed that pollution makes allergies worse. It has also been~     suggested that very small particles may affect allergies more than larger particles.~   "
137257|NCT01257178|"~     The purpose of this study is to evaluate the impact of hepatic dysfunction on the~     pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.~   "
137258|NCT01257165|"~     Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from~     drivers suspected of driving under the influence. In this study, the investigators aim to~     correlate zopiclone serum concentrations with degrees of driving impairment in healthy~     volunteers by use of a validated driving simulator. The investigators also aim to compare~     their results with the results from a previous study that investigated zopiclone impairment~     of cognitive and psychometric tests.~   "
137259|NCT01257152|"~     A prospective, multicenter study:~        -  Primary objective: to assess the diagnostic yield of screening MRI compared to physical~          examination, mammography or ultrasonography in the detection of recurrence in patients~          treated with breast conserving therapy~        -  Secondary objective: to describe the size, type, grade, and nodal status of cancers~          seen only on MRI and to estimate the rate of benign biopsies and short interval~          follow-up induced only by MRI in this population.~   "
137260|NCT01257139|"~     This is a phase III randomized multicenter study involving subjects over 70 years of age~     with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously~     received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS)~     as a screening tool. If the SGS results are normal, the patient will be treated with~     dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non~     epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further~     geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric~     evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale,~     who will receive either monotherapy (docetaxel) or best supportive care.~      The strategy based on the SGS will be compared with a treatment algorithm based on standard~     criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time~     to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional~     assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified~     cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression~     scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia,~     repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison~     with the CGE, that will be administered systematically at enrollment. All the SGS items are~     included in the CGE.~      Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL~     questionnaires), overall survival, the objective response rate, and toxicity. The~     investigators will also study the predictive power of nutritional indices such as the PINI~     and the Buzby score with respect to survival, the treatment response, and tolerability.~   "
137261|NCT01257126|"~     This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to~     7 years. The objective of the study is to compare the efficacy of a single dose of both~     diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper~     respiratory tract infection.~   "
137263|NCT01257100|"~     Background:~      - Nasopharyngeal carcinoma (NPC) a common malignant tumor in southern China and Southeast~     Asia. Infection with Epstein-Barr virus is believed to be necessary for the development of~     NPC; non-viral environmental factors, such as dietary consumption of nitrosamines, cigarette~     smoking, betel nut chewing, wood dust exposure and possibly exposure to formaldehyde, have~     been implicated in the disease. Genetic susceptibility may also play an important role in~     the development of NPC. However, more information is needed on the connections between~     genetic and environmental factors in NPC, particularly in areas where the cancer risk~     appears to be greatest.~      Objectives:~      - To examine the main effects of genetic factors and environmental exposures (e.g.,~     cigarette smoking, betel nut chewing, formaldehyde, wood dust) on nasopharyngeal carcinoma~     risk.~      Eligibility:~        -  Cases: Individuals at least 21 years of age who have been diagnosed with NPC at one of~          the participating hospitals and have been residents of northern Taiwan for at least 6~          months.~        -  Controls: Hospital patients with diseases other than NPC at least 21 years of age,~          matched to NPC patients based on hospital, age at diagnosis, gender, and ethnicity.~      Design:~        -  This study involves a risk factor interview, medical record abstraction and biological~          sample collection.~        -  Participants will respond to interview questions about their lifestyle and risk factors~          thought to be involved in NPC development.~        -  All participants will provide blood and saliva samples for study. Participants who have~          been diagnosed with NPC will also provide consent to allow researchers to study tissue~          samples taken during tumor biopsies or surgeries.~        -  Treatment will not be provided as part of this protocol.~   "
137264|NCT01257087|"~     Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients~     with obesity. Many patients stop or reduce their medication after surgery and this can~     happen fairly quickly. The investigators do not know whether strict control of blood~     glucose/sugar after the operation makes any difference in the long term. Additionally many~     patients prefer their blood sugars to be a bit high because they are afraid of hypos.A~     number of studies have described patients whose eye, nerve and kidney disease has~     deteriorated when high sugars are controlled very quickly. The investigators want to ensure~     that surgery provides maximum benefit and remains safe in patients with diabetes. This study~     will help us decide if the investigators should be strict with blood glucose after obesity~     surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney~     complications of diabetes.~   "
137265|NCT01257074|"~     Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of~     this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as~     treatment for Herpes Labialis in comparison to acyclovir 50mg/g.~   "
137266|NCT01257061|"~     Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity~     and impaired quality of life due specially pruritus and physical visible skin lesions. The~     propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g +~     dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.~   "
137267|NCT01257048|"~     The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced~     magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients~     with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment~     with either Oxis Turbuhaler or Symbicort Turbuhaler.~   "
137268|NCT01257035|"~     The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of~     response to neoadjuvant chemoradiation of locally advanced rectum cancer.~   "
137269|NCT01257022|"~     The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United~     Families), a family-based, ecodevelopmental intervention found to be previously efficacious~     in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior~     in non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al.,~     2007).~      The study hypotheses are as follows:~      Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     drug use among Hispanic first offending adolescents or those who are at risk for committing~     a first time offense over time.~      Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by~     improvements in family functioning.~      Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk~     for committing a first time offense over time.~      Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially~     mediated by improvements in family functioning.~      Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing~     subsequent criminal offenses among Hispanic first offending adolescents or in preventing a~     first time offense for those at risk for committing a first time offense over time.~      Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be~     mediated by family functioning.~   "
137270|NCT01257009|"~     Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity~     which appears to contribute to the pathogenesis of hypertension and cardiovascular organ~     damage. Experimental studies and some clinical studies have shown that statin therapy can~     reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which~     is standard treatment for CKD, is known to lower sympathetic activity.~      The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further~     lower sympathetic activity in hypertensive stage 2-4 CKD patients.~      Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis~     blockers, blood pressure and sympathetic activity (quantified by assessment of muscle~     sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after~     atorvastatin 20mg/day added.~      Ten other CKD patients will serve as time control and will be studied twice with an interval~     of 6 weeks without any change in medication, to quantify within subject reproducibility.~   "
137271|NCT01256996|"~     In the last decade, the number of dental implantations continuously increases. However, at~     the same time, the prevalence of peri-implantitis increases, too. Although both surgical and~     non-surgical interventions are available for the therapy, there is no efficient and~     satisfying therapy option resulting in an adequate improvement of this disease.~      An innovative, low abrasive powder has been introduced for the therapy of periodontitis.~     However, the powder might be suitable for the peri-implantitis therapy, also, and could~     improve the effectiveness of the therapy. The usage of this powder in peri-implantitis~     patients has not been assessed in a clinical trial although the effectiveness in natural~     teeth has been demonstrated.~      The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness~     of the aforementioned powder in peri-implantitis patients.~   "
137357|NCT01257594|"~     The purpose of this study is to test the effectiveness of a drug called erlotinib in~     treating the tumor. This is a multi-center pilot study that explores efficacy and molecular~     effects of high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and~     correlate molecular profile of pre-treatment tissue with outcome.~   "
137272|NCT01258426|"~     Recently, seslenium(Se) has known as important regulator in metabolic status, lipid profile,~     atherosclerosis progression. SEPP1(selenoprotein P1)is a secreted protein from mainly liver.~     This protein is used as an index of selenium nutritional status. The association between the~     concentration of SEPP1(selenoprotein P1) in normal glucose tolerance,impaired glucose~     tolerance, type 2 diabetes is still a matter of debate. This cross sectional study will~     evaluate whether glucose status is matter in SEPP1 level.~   "
137273|NCT01258413|"~     The purpose of this study is to determine whether laparoscopic radical hysterectomy for~     early cervical cancer will has decreased postoperative pain intensity compared to abdominal~     radical hysterectomy with similar postoperative complications and survival rates.~   "
137274|NCT01258387|"~     Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single~     intravenous administrations of GGF2 in patients with heart failure.~   "
137275|NCT01258374|"~     While 3-drug regimens remain standard of care, concerns exist regarding the safety of~     multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted~     successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and~     efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to~     have potent activity when patients have few active background drugs; it has a superior lipid~     profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with~     few GI side effects and lipid disturbances and with a high genetic barrier. The~     investigators hypothesized that RAL/DRV would be a well tolerated and effective regimen for~     those patients who are failing nucleoside reverse transcriptase inhibitors based regimens,~     due to poor tolerability or resistance. The investigators also would like to explore the~     plasma pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12~     HIV-infected patients.~   "
137276|NCT01258361|"~     The primary objective of this study is to demonstrate that preoperative fasting does not~     increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg~     lift) in patients undergoing surgery.~   "
137277|NCT01258348|"~     The purpose of this study is to determine a safe dose of LY573636-sodium to be given in~     combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to~     determine any side effects that may be associated with LY573636-sodium and sunitinib~     combination in this patient population. The tumor response rate will also be assessed.~   "
137278|NCT01258335|"~     Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral~     omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).~      Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.~   "
137279|NCT01258322|"~     1. Background:Cardiovascular disease (CVD) is the major cause of mortality in peritoneal~          dialysis (PD) patients, in whom it is partly attributable to a higher prevalence of~          dysmetabolism. Currently, few treatments are available with a proven effect on~          dyslipidemia, insulin resistance and inflammation in this patient group.~        2. Study design: Randomized, cross-over trial.~        3. Settings and Participants: Prevalent PD patients (＞20 years old, s-triglycerides ＞1.8~          mmol/L) who had never received glitazones were enrolled.~        4. Interventions: Participants were randomized to receive either oral pioglitazone (PIO;~          15 mg once daily) and no pioglitazone, both for 12 weeks and in random order, with a~          four-week wash out in between.~        5. Outcomes and measurements: The primary endpoint was change of serum triglyceride (TG)~          level during the PIO as compared to no PIO. Secondary endpoints included changes in~          other lipid levels, HOMA-IR, adipocytokines and CRP. Outcome effects were assessed~          using a GLM.~   "
137280|NCT01258309|"~     This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac~     tromethamine fixed dose combination ophthalmic solution compared with olopatadine~     hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.~   "
137281|NCT01258296|"~     The aim of this randomized, double-blind controlled trial is to determine the efficacy of~     transdermal fentanyl for the management of early postoperative pain in women undergoing~     mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether~     the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve~     overall pain relief compared to placebo patch. We further propose to study whether the~     fentanyl patch is associated with improved ability to sleep, patient satisfaction, and~     functional capacity at one week, and whether it is associated with different side effects~     than standard therapy without the patch. Following informed consent, patients will undergo~     mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative~     analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on~     postoperative day three, and the epidural will be weaned over the next 12 hours. Pain~     intensity scores and relief from pain will be assessed every day while in the hospital and~     oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2~     patches and oral medication, and will be asked to fill out a daily pain and medication log.~   "
137282|NCT01258283|"~     The main objective of this study is to determine among the patients included a subpopulation~     that does not need a defibrillator.~      This will be done by comparing the number of discordant segments (mismatch) between patients~     who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with~     appropriate electrical therapy within 3 years of monitoring and others. Mismatch in the~     definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123~     metaiodobenzylguanidine) and PET at 0,1,2.~   "
137283|NCT01258270|"~     The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag~     Surgical Dressing (treatment group) as compared to prepackaged island wound dressings~     consisting of traditional tape and gauze (control group) for total hip and total knee~     arthroplasty.~   "
137284|NCT01258257|"~     The intention of the study is to investigate whether drainage of cerebral spinal fluid via a~     lumbar route (Tuohy-drain) will improve outcome after intracranial aneurysmal subarachnoid~     hemorrhage (SAH).~   "
137298|NCT01258075|"~     Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM)~     to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have~     been treated with Metformin or have had no antidiabetic drug treatment in the previous three~     months.~      Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well~     tolerated, and shows improved blood sugar control (as evidenced by a significant change from~     baseline in hemoglobin A1C [HbA1c]).~   "
137285|NCT01258244|"~     The quality of cardiopulmonary resuscitation (CPR) provided to patients with out-of-hospital~     cardiac arrest (OHCA) is often suboptimal. There now exist monitors/defibrillators that~     allow for the measurement and real time feedback of the quality of chest compressions and~     ventilations. In addition to giving the prehospital provider the benefit of real time CPR~     quality feedback via voice and visual cues, the CPR quality data acquired using these~     devices can be utilized as part of an on-going quality assurance/quality improvement~     program.~      The first objective of the proposed project is to quantify the quality of chest compressions~     and ventilations provided in the state of Arizona to patients with OHCA and to determine~     whether the quality of CPR is related to patient outcome from OHCA.~      A second objective of this project is to determine whether use of audiovisual feedback~     improves both CPR quality and patient outcome in the pre-hospital setting.~   "
137286|NCT01258231|"~     This study aims to identify genetic causes of adverse events after cardiac surgery, such as~     atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.~      Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute~     are eligible to participate.~   "
137287|NCT01258218|"~     The intent of this study is to evaluate the performance of the implanted Accent MRI TM~     system in a clinical setting and optionally in the MRI environment. This system includes the~     St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI~     Activator™ will be evaluated in this study. The MRI Activator is a handheld device that~     allows the user to enable and disable MRI Settings as well as check the status of MRI~     Settings in the pacemaker. The patient population under study includes patients with a~     standard bradycardia pacing indication.~   "
137288|NCT01258205|"~     The purpose of this study is to assess the safety and tolerability of AMG 139 following~     multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and~     in subjects with mild to severe Crohn's disease (CD).~   "
137289|NCT01258192|"~     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy~     with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma~     patients.~   "
137290|NCT01258179|"~     The purpose of this study is to analyze the peri-operative expression of pancreatic stone~     protein and pancreatitis-associated protein in surgical patients following major abdominal~     surgery by blood samples.~   "
137291|NCT01258166|"~     Ulnar translocation of the carpus is a form of wrist instability where the small bones of~     the wrist shift out of position. It is well recognized in patients with rheumatoid~     arthritis, but can also occur after a traumatic event, such as a violent football tackle or~     a fall from a height. The treatment options vary considerably, and there is no consensus of~     how to best address this injury pattern.~      Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or~     delayed, causing problems for the patient such as persistent pain and loss of function. The~     investigators present 11 cases of this injury, discuss how to recognize it, and report our~     results after different treatment methods.~   "
137292|NCT01258153|"~     This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind,~     placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and~     safety of Nepadutant given at two oral doses once daily for seven days in comparison to~     placebo in the treatment of infantile colic.~   "
137293|NCT01258140|"~     Computed tomography pulmonary angiography (CTPA) is the imaging method of choice to rule out~     acute pulmonary embolism based on its high sensitivity and specificity. Unfortunately, CTPA~     uses iodinated contrast media and can provoke contrast induced nephropathy. On the other~     hand, Computed tomography uses ionising radiation and is responsible for the half of the~     radiation exposure coming from medical sources.~      Recent studies have proven that low-dose CTPA protocols using Computed tomography tube~     energy of 80 kVp and reduced volume of iodinated contrast media provide an increased vessel~     signal and good image quality at a significantly reduced patient exposure. However, there~     are no data on the sensitivity of low-kVp protocols.~      The aim of this prospective randomized trial is to detect any difference between a~     normal-dose and a low-dose CTPA protocol in the diagnostic accuracy in the detection of~     acute pulmonary embolism (PE).~   "
137294|NCT01258127|"~     The main purpose of this randomized phase II trial is to evaluate the clinical feasibility~     and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with~     vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer~     (NSCLC).~   "
137295|NCT01258114|"~     Public health campaigns and industry-supported changes in our food supply have obviously~     failed to control the epidemic to date. However, customized life style modification programs~     (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles~     designed to help patients achieve their goals) induce weight loss of 10% of baseline body~     weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated~     by an appropriate weight-loss maintenance strategy such as continued patient-therapist~     contact (whether provided in person or by telephone or e-mail). This strategy allows~     patients to stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2~     years, respectively. Numerous reports have concluded that this modest weight loss~     contributes to important health benefits.~      However, the high dropout rate during weight-management strategies presumably means that~     treatment is mainly effective in highly motivated patients, as the highest success rates are~     likely to be reported among study completers. Many individuals appear to conclude that the~     benefits of weight-management strategies are not worth the cost (i.e. time, money, and~     continued unrewarding efforts). This underlines the critical need to implement new,~     practical and affordable strategies to induce and maintain weight loss that can be achieved~     by most patients.~      The main objective of this study is to test the hypothesis that a 3 week intensive course of~     spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months~     (BMI from 27 to 35).~   "
137296|NCT01258101|"~     This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys~     (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with~     chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups~     receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two~     doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment~     is 16 or 24 weeks with a 24-week follow-up.~   "
137299|NCT01258062|"~     This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal~     powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of~     age who are eligible for study participation will be enrolled in the trial. It is expected~     that 10 subjects will be screened to obtain 7 subjects who will be eligible for study~     participation.~      The primary objective is to determine the frequency and severity of local and systemic~     adverse events of vaccine.~      The secondary objective is to assess the immunogenicity of the vaccine based on geometric~     mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.~   "
137300|NCT01258049|"~     The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is~     better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after~     the start of treatment in children with severe malaria, or uncomplicated malaria with~     gastrointestinal complications~   "
137301|NCT01258036|"~     The aim of this study is to analyze the hereditary determinism of bone microarchitecture~     measured at the distal radius and distal tibia from a case control-study of mother-daughter~     pairs.~   "
137302|NCT01258023|"~     The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad~     (R) in immunocompromised adults who have undergone solid organ or bone marrow~     transplantation. It is expected that when administered once the vaccine fulfills all~     serological efficacy criteria required for the elderly population age 60 years and older.~   "
137303|NCT01258010|"~     Spinal surgery may be associated with substantial blood loss which often requires~     erythrocyte transfusion. Transfusion of red blood cells (RBC) is not free of adverse events~     and has been associated with increased risks of infection, and globally higher morbidity and~     mortality.~      Different techniques have been used to reduce perioperative blood losses and related~     transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery.~     However, only a few studies have reported on the use of antifibrinolytic drugs in spinal~     surgery.~      This study was designed to assess the efficacy and safety of tranexamic acid in spinal~     surgery for the reduction of RBC transfusion.~      Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of~     receiving a RBC transfusion and, in those patients transfused, reduce the number of blood~     products administered.~   "
137304|NCT01257997|"~     This pilot study is using a novel technology to measure the rate of turnover of new fat~     cells. Analysis of volunteer samples is ongoing, however the study is currently not~     enrolling new volunteers.~   "
137305|NCT01257984|"~     The objective of the study is to evaluate the effect of the dispenser's buzzer function on~     compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP)~     containing oral contraceptive (OC) in a flexible extended regimen when administered for~     approximately 12 months to healthy female volunteers who request contraception.~   "
137306|NCT01257971|"~     This is a multi-centre non-interventional study of patients who are treated with any HMGCoA~     reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and~     fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in~     accordance with SmPCs approved in Croatia. Data collection for each patient will take place~     at a single visit. The investigator will complete a Case Report Form with the patient's~     demographics, the presence of the factors for high cardiovascular risk, current treatment,~     cholesterol values as well as with further treatment decision.~   "
137307|NCT01256983|"~     Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian~     rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective~     disorder, jet lag and shift work. These people experience a serious mood change when the~     seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances,~     little energy, and often feel depressed. An established intervention to treat this disorder~     is bright light therapy. Light therapy is used for affective disorders for shift workers,~     jet lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy~     measures for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known~     from cross sectional studies that renal transplant (RTx) recipients have a prevalence~     between 30% to 62% of poor sleep quality measured by self report; a prevalence of impaired~     daytime functioning of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%.~     Sleep-wake dysregulation in other chronically ill population are a risk factor for morbidity~     and mortality.~      RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively~     problems. The psychosocial variables that should be addressed, having an association with~     morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive~     medication, exercise, smoking and depressive symptomatology.~      In the following research project we will address the following gaps: the fact that nature~     of sleep disturbances in RTx recipients has never been assessed, that there is no prevalence~     available on sleep-wake dysregulation and that there is no data on bright light therapy~     intervention in RTx recipients.~      Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an~     improved sleep quality and less daytime sleepiness after 21 days of light therapy.~   "
137308|NCT01256970|"~     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive~     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic~     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous~     as the syndrome. This first part of study is determine whether genetic polymorphisms~     influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and~     controls. Furthermore, women with PCOS were reported with high risk of cardiovascular~     disease, the investigators planned to calculate the difference of carotid intima-media~     thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal~     control to determine the premature atherosclerosis of women with PCOS.~   "
137309|NCT01256957|"~     The purpose of this study is to evaluate the ability of portable high efficiency particle~     air (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to~     improve subclinical indicators of microvascular function, systemic inflammation, and~     oxidative stress among healthy adult participants.~   "
137350|NCT01257685|"~     The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most~     widely supported theory implicates insulin resistance as the key mechanism leading to~     hepatic steatosis, and perhaps also to steatohepatitis.~      Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous~     studies demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.~      Therefore, the purpose of this study is to determine the different Sep levels between~     healthy normal group and NAFLD group.~   "
137358|NCT01257581|"~     The purpose of the study is to evaluate the safety and efficacy of high dose creatine and~     two dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).~   "
137359|NCT01257568|"~     This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip~     replacement (THR) with a cementless application in a consecutive series of patients who meet~     the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years~     and clinical outcomes for up to 10 years after surgery.~   "
137310|NCT01256944|"~     Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive~     age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic~     criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous~     as the syndrome. Of those diagnosed with PCOS using the 2003 Rotterdam criteria, 61%~     fulfilled 1990 NIH criteria for unexplained hyperandrogenic chronic anovulation. The patient~     populations with the new phenotypes had less severe ovulatory dysfunction and less androgen~     excess than patients diagnosed using the 1990 NIH criteria. These findings might be common~     across all female populations with PCOS, whether in Oriental or Occidental countries. Data~     for clinical hyperandrogenism indicated that the prevalence of hirsutism in Taiwanese PCOS~     women is lower than that for Caucasians/Western women.~      The extent of metabolic abnormalities in women with PCOS may vary with phenotype, age and~     ethnicity. Obesity represents a major risk factor for metabolic syndrome and insulin~     resistance. Approximately 40-50% of all women with PCOS are overweight or obese. Obese~     subjects with PCOS had a higher risk of developing oligomenorrhea, amenorrhea and~     biochemical hyperandrogenemia than non-obese women with PCOS. Moreover, obese women with~     PCOS had significantly more severe insulin resistance, lower serum LH levels, and lower~     LH-to-FSH ratios than non-obese women with PCOS. PCOS women in Taiwan presented with higher~     LH-to-FSH ratio and lower insulin resistance than PCOS women in Western Countries. However,~     the average body mass index (BMI) was significantly lower in Taiwanese PCOS women than~     Western women, which might partially explain the difference between these two populations in~     terms of clinical and biochemical presentations.~      To further document the ethnic variation between women with PCOS in Taiwan and Western, the~     effect of obesity on the diagnosis and clinical presentations of PCOS-related syndromes~     should not be neglected in future studies. Therefore, the investigators plan to do this~     prospective study for evaluation the clinical and biochemical presentation of Taiwanese~     women with PCOS.~   "
137311|NCT01256931|"~     Organ transplant patients who participated in a retrospective study and received 2009~     Pandemrix vaccine during autumn 2009 are included in this study.~      The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison~     to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in~     patients and controls.Side effects to Fluarix vaccine are registered.~   "
137312|NCT01256918|"~     There is a correlation between phacodepth required for full thickness nuclear crack and the~     various grades of cataract~   "
137313|NCT01256905|"~     The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time~     sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in~     the attention commonly reported by patients with more advanced Parkinson's disease (PD) and~     Lewy body disease (LBD).~   "
137314|NCT01255228|"~     Excessive body weight and obesity have reached epidemic proportions over the last few~     decades, which may cause many chronic diseases. Maintaining a healthy life style could~     decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study~     aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body~     composition and the mechanism of obese women. The pilot study will recruit twenty healthy~     subjects, and served test food to determine low GI food. In the experiment period, twenty~     women age from 20-50 years will be recruited. To be included in the study, subjects should~     have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before~     dietary intervention, participants will receive food choice table and dietary questionnaires~     to record their dietary intake.~      The study will be a randomized, crossover, controlled clinical trails. The experiment period~     have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3,~     6 week, subjects will measurement their body composition (body weight, body mass, waist and~     hip circumferences) and collect fasting blood samples to analysis the lipid profile, free~     fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes.~     Statistical analysis will be performed by paired t-test. The study expect that long-term low~     GI diet intervention have beneficial effects on regulate body composition of obese women.~   "
137315|NCT01255215|"~     Despite the use of highly effective anti-malarial medications, 10-30% of African children~     with severe malaria will die, underscoring the need for adjunctive therapies that can be~     applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in~     severe malaria is warranted on the basis of firm proof of concept from animal studies and a~     human study using the NO donor L-arginine, together with evidence of safety from clinical~     experience and trials of iNO for other conditions. Our objective is to determine whether~     supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels~     of Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with~     severe malaria compared to Standard of Care treatment alone. We will conduct a randomized~     placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital~     (Uganda) with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.~   "
137316|NCT01255202|"~     The purpose of this study is to finout whetere uterinae artery flow , PP13 and endogolin~     levels in the serum and kongo red in the urine can predict preeclamsia toxemia in twin~     pregnancies.~   "
137317|NCT01255189|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral oxygenation in newborn infants. Using this technique we~     investigated the effect of positional changes on cerebral oxygenation in preterm infants.~   "
137318|NCT01255176|"~     It gave a clinical trial which will be included in the 60 infants, aged up to 24 months,~     diagnosed with congenital's population will be divided by simple randomization into three~     groups: 20 infants in the intervention group, 20 infants in the control group, not receive~     the RTA technique and another 20 infants in a placebo group, we just get the support manual~     therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory~     rate and oxygen saturation. Then the researcher will apply three specific rating scales,~     based on clinical presentation and behavior of infants. Hypothesis: The RTA improves~     cardiorespiratory parameters and reduces signs of discomfort and pain of infants with~     congenital heart acyanogenic.~   "
137351|NCT01257672|"~     Vomiting in children with acute gastroenteritis is a major factor of failure of oral~     rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important~     reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic~     treatment of vomiting shows the efficacy of the most recently registered molecule~     (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical~     practice, such as domperidone, is lacking.~      The aim of this multicentre, double-blind randomized controlled trial is to compare the~     efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in~     children with acute gastroenteritis who have failed Oral Rehydration Therapy.~   "
137352|NCT01257659|"~     The primary objective of this study is to compare the function results between two methods~     for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working~     hypothesis is that the relatively new type of endo-anal surgery will result in better~     voiding function compared to the traditional vaginal surgery.~   "
137319|NCT01255163|"~     Background:~      - Exendin-4 (or Exenatide) is a medication currently used to treat diabetes, but it has~     shown promising results in tests of its effectiveness in protecting neurons from damaging~     processes associated with Alzheimer s disease. It is possible that Exendin-4 may be a~     treatment for Alzheimer s disease, which involves the gradual deterioration and death of~     neurons. Researchers are interested in studying the safety and comparing the effects of~     Exendin-4 with placebo to on congestive performance, overall clinical progression, various~     chemicals measured in blood and cerebrospinal fluid, and brain MRI, in individuals with~     early-stage Alzheimer's disease or mild cognitive impairment.~      Objectives:~      - To determine the safety and tolerability, as well as to acquire preliminary evidence for~     the effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage~     Alzheimer s disease or mild cognitive impairment.~      Eligibility:~      - Individuals at least 60 years of age who have objective evidence of early-stage~     Alzheimer's disease or mild cognitive impairment in screening testing.~      Design:~        -  Participants will be screened.~        -  Following the telephone screening, two in-person screening visits to determine~          eligibility.~        -  The screening visit will involve a medical history and neurological examination, tests~          of memory and cognition, a lumbar puncture, collection of blood and saliva samples, and~          brain Magnetic Resonance Imagine (MRI) studies. Participants will be required to~          appoint a Durable Power of Attorney for research and medical care during this protocol.~        -  Eligible participants will be divided into two groups. One group will receive~          Exendin-4, and the other will receive a placebo. Participants will keep a medication~          diary and will be scheduled for additional study visits 1 and 2 weeks after the start~          of the treatment.~        -  Participants will have regular followup visits with blood tests, imaging studies, and~          other examinations 6, 12, and18 months after the start of the treatment. Another lumbar~          puncture may be performed optionally at the 18-month followup visit.~   "
137320|NCT01255150|"~     Background:~      - Research has shown that the Epidermal Growth Factor Receptor (EGFR) gene is an important~     target for personalized lung cancer treatment. Individuals who have mutations in the EGFR~     gene have better responses when treated with certain personalized or targeted therapies~     compared with conventional chemotherapy. These mutations are more frequent in females with~     lung cancer who have never smoked, and different ethnic groups have different levels of~     frequency of the mutations. Researchers are interested in collecting more information on~     EGFR genetic mutations in Hispanics/Latinos with lung cancer, comparing the frequency of~     these mutations in males and females and smokers and nonsmokers. This study may lead to~     better, more personalized care approaches for all individuals with lung cancer.~      Objectives:~      - To study the frequency of Epidermal Growth Factor Receptor mutations in Hispanic/Latino~     individuals who have been diagnosed with non-small cell lung cancer.~      Eligibility:~      - Hispanic or Latino individuals who have been diagnosed with non-small cell lung cancer and~     who have lung tissue from a previous biopsy or surgery available for research purposes.~      Design:~        -  Participants will provide consent for researchers to examine lung tissue collected from~          a previous biopsy or surgery.~        -  Treatment will not be provided as part of this protocol....~   "
137321|NCT01255137|"~     Background:~      - Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the~     top of the kidneys. It has a low survival rate if standard treatment options are not~     effective. Axitinib is an experimental drug that is being studied to determine if it can~     stop tumors from growing or make them smaller. Researchers are interested in investigating~     axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer.~      Objectives:~      - To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer~     that is inoperable and has not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer~     that has not responded to standard treatments.~      Design:~        -  Participants will be screened with a full physical examination and medical history, as~          well as tumor imaging studies.~        -  Participants may have a tumor biopsy prior to starting axitinib.~        -  All participants will receive axitinib to take twice a day with food for 28 days (1~          cycle). Participants should not drink grapefruit juice or smoke cigarettes while~          participating in this study.~        -  After the first cycle, the dose may be increased and additional cycles will be given if~          the treatment has not had serious side effects.~        -  Participants will have regular examinations while taking axitinib, including blood~          samples and tumor imaging studies to determine if the tumor has stopped growing. Blood~          pressure levels will be carefully monitored during treatment to evaluate potential risk~          for high blood pressure.~        -  Participants may have a second tumor biopsy 20 to 30 days after treatment begins.~        -  Treatment will continue as directed by the study researchers.~   "
137322|NCT01255124|"~     Hand, Foot and Mouth Disease（HFMD）is an infectious disease in infants and young children~     caused by enterovirus. There was a great outbreak of HFMD in China, 2008, which brought not~     only panic to the people, but also huge economic loss. Since 2008, HFMD has become one of~     the category c infectious diseases in China. Studies showed that Human Enterovirus 71 (EV71)~     and coxsackievirus A 16 (CVA16) are the most common reasons for this disease. And the~     investigators are going to develop the vaccines for this disease. There is an urgent need to~     know the dynamic changes of the maternal anti-EV71 and ant-CVA16 level in infants and young~     children. In April 2007, the investigators started a clinical trial named 'The Safety and~     Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'~     (ClinicalTrials.gov ID: NCT01183611). In that study the investigators already built a cohort~     of Health Neonates, followed them and obtained the blood serum on the day 0, 30, 210 and 360~     after born. So, based on the cohort and blood serum the investigators got, the investigators~     plan this study to retrospectively investigate their HFMD histories from birth and follow-up~     for another year to get the information about the incidence of HFMD. The investigators also~     plan to assay the maternal anti-EV71 and anti-CVA16 antibodies on the day0 and the dynamic~     changes of antibodies on 1st month, 7th month (day 210), 1st year (day 360) and on October,~     2010.~   "
137323|NCT01255111|"~     BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability~     and efficacy of this treatment during sleep in patients with chronic respiratory failure.~      AIM: To study the variability of patient-ventilator interactions during the first nights~     after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the~     non-linear dynamics theory.~      PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and~     indicated to home NIV will be included. All patients will perform three polysomnographies~     (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All~     ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen~     saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep~     Laboratory of the Department and secondarily related to sleep architecture and quality of~     sleep.~      EXPECTED RESULTS: This study will identify objective parameters that are associated to a~     satisfactory adaptation to nocturnal NIV.~   "
137360|NCT01257555|"~     The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy~     for the treatment of acne and concomitant symptoms associated with the disease, including~     erythema.~   "
137324|NCT01254123|"~     Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular~     function, morbidity and mortality. The most effective therapy is early reperfusion of the~     ischemic myocardium by percutaneous coronary intervention (PCI). Reperfusion limits~     myocardial ischaemic necrosis, but also induces inflammation, oxidative stress and calcium~     overload: a process referred to as reperfusion injury leading to necrosis and apotosis.~     Glucagon Like Peptide-1 (GLP-1) is an incretin hormone that has shown to activate~     anti-apoptotic enzymes, reducing reperfusion injury. GLP-1 agonists have been demonstrated~     to be cardioprotective in several animal studies and in a single small non-randomized~     clinical study. In this pilot study we will assess the safety and efficacy of GLP-1 receptor~     agonist Exenatide infusion compared to placebo in patients with an acute myocardial~     infarction undergoing primary PCI.~      A total of 40 patients will be included in this single centre prospective randomised placebo~     controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute~     ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus~     in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours.~     Blood samples are obtained for assessment of enzymatic infarct size and Exenatide levels.~     Side effects of Exenatide are stringently monitored. Cardiac function will be measured using~     Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months~     post MI. Infarct size will be assessed by means of the final infarct size at 4 months post~     MI as a percentage of the area at risk at 1 week post MI. Furthermore we will compare the~     RNA profile of both groups.~   "
137325|NCT01254110|"~     Gut protein metabolism that could be influenced by protein supply is involved in the~     regulation of several physiological functions such as gut barrier function and represents a~     major contribution in the whole-body protein turnover. Intracellular pathways implicated in~     the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of~     the present project is to evaluate and to understand the effects of amino acids (glutamine,~     leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.~   "
137326|NCT01254097|"~     Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are~     common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the~     protective 'good' bacteria in the body. This research will test if taking a probiotic with~     prescribed antibiotics will decrease the chance of having bothersome antibiotic-associated~     side effects.~   "
137327|NCT01254084|"~     The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea~     on insulin sensitivity in drug-naïve type 2 diabetic patients.~   "
137328|NCT01254071|"~     This study will be an open-label, randomized, single dose, two-period crossover study to~     determine the bioavailability of a fixed dose combination capsule formulation of dutasteride~     and tamsulosin hydrochloride (0.5mg/0.2mg) relative to co-administration of dutasteride~     0.5mg capsules and tamsulosin hydrochloride 0.2mg tablets in healthy male subjects of North~     East Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination~     capsule formulation of dutasteride 0.5 mg/ tamsulosin 0.2 mg in a fed or fasted state or~     concomitant dosing of dutasteride 0.5 mg and the Japan-sourced Harnal-D 0.2 mg in a fed or~     fasted state. Each dose of study medication will be separated by a 28-day washout period.~     Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.~     Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory~     data, and review of adverse events. The study will enrol 88 healthy male subjects to ensure~     that 80 complete the study. At least twenty percent of the study population will be of~     Japanese ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of~     Korean ancestry while the remainder of the population will be of non-Asian ancestry.~   "
137329|NCT01257958|"~     Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.~   "
137330|NCT01257945|"~     This randomized, controlled exercise intervention with three groups compares two exercise~     approaches to standard of care. Supervised interventions are administered for four months,~     with emphasis on patients adopting exercise habits to continue to exercise for an additional~     12 months. Functional outcomes are measured at the completion of the supervised exercise (4~     months) as well as 10 and 16 months.~   "
137331|NCT01257932|"~     The investigators have developed imaging protocols to monitor and predict breast cancer~     response to neoadjuvant chemotherapy, both prior to and as early as possible during the~     course of treatment.~      The efficacy and practicality of conventional imaging approaches in the neoadjuvant~     chemotherapy setting varies and identifies the need for alternate functional imaging~     strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that~     allows patients to be followed from baseline through treatment and surgery with a~     cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized~     diffuse optical spectroscopic imaging technology platform that has been standardized for~     neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic~     research platform that is non-invasive. Studies will be performed in five clinical sites on~     approximately 60 neoadjuvant chemotherapy patients.~   "
137332|NCT01257919|"~     Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in~     comparison to Azelaic Acid gel.~      Assessment of safety after repeated skin application.~   "
137333|NCT01257906|"~     ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The~     Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne~     vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin~     phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to~     evaluate the bioequivalence of this formulation to ZIANA®.~   "
137353|NCT01257646|"~     The main objective of this study is the estimation and comparison of the dephasing between~     the switch heel and the inertial placed on the paretic foot compared to the events of the~     gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in~     conditions without stimulation.~   "
137354|NCT01257633|"~     The main objective of this study is to determine the rate of healthy surgical margins after~     tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early~     stage (T1-T2) laryngeal cancer.~   "
137361|NCT01257542|"~     15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the~     number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.~   "
137334|NCT01257893|"~     The purpose of this study is to compare the rates of aspirin resistance (high residual~     platelet reactivity) between women with episodic and chronic migraine and women without~     migraine.~      Emerging evidence suggests that migraineurs, especially women < 45 years who have aura, have~     an increased risk of stroke and myocardial infarction (MI, or heart attack). The mechanism~     linking migraine, stroke and MI is unclear although increased platelet activation and~     aggregation observed during and between migraine attacks may be a plausible theory.~      Aspirin is an inexpensive, relatively safe antiplatelet drug that reduces the risk of stroke~     and MI. Preliminary data suggest that aspirin's (325mg) therapeutic effect on platelet~     inhibition may be reduced in migraineurs (i.e., aspirin resistance), thus limiting aspirin's~     effectiveness at preventing stroke and MI risks in persons with migraine. Additional~     research is warranted to confirm these findings in migraineurs because daily, low-dose~     aspirin 81 mg is the recommended first line therapy for primary and secondary prevention of~     stroke and MI~      The researchers hypothesize that resistance to aspirin 81mg may occur more frequently in~     women with episodic and chronic migraine than in women without migraine. The findings may~     have important implications for women who have migraine and use aspirin to prevent migraine~     symptoms or comorbidities associated with migraine including stroke and MI.~   "
137335|NCT01257880|"~     The purpose of the study is to compare the rate of comorbidities associated with migraine~     aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those~     who do not have RLS.~      Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale~     (PFO). A PFO is an anatomical opening or flap between the upper chambers of the heart or~     atria that permits blood to pass from the right of the heart to the left side of the heart,~     without first going to the lungs to be filtered and oxygenated. Many health conditions and~     clinical syndromes including stroke, sleep apnea, and migraine have been linked to PFO.~     Although the mechanism is undetermined, it is hypothesized that microscopic blood clots and~     chemicals such as serotonin can pass through the PFO, travel to the brain, and cause~     headache and aura.~      Persons who have MA are at increased risk for stroke and transient ischemic attacks relative~     to people who do not have migraine. Migraine is also associated with the presence of white~     matter lesions in the brain and mild deficits in cognitive function associated with the~     posterior brain (vision, memory, processing speed). The risk of stroke in migraine is~     highest for women under the age of 45 who have aura and a high number of migraine headache~     days per month. No convincing evidence has been produced to explain the mechanism for the~     increased risk of ischemic stroke in migraine; however, increased platelet activation and~     aggregation is a plausible theory.~      We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be~     more likely to have sleep apnea, increased platelet activation, cognitive deficits,~     alterations in cerebral vasomotor function, and white matter lesions than migraineurs with~     aura who do not have PFO. The results of this exploratory study will generate hypotheses as~     to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO~     on comorbid conditions associated with migraine aura. Early identification of migraine~     subgroups with a constellation of clinical syndromes that increase risk of neurovascular~     diseases will allow initiation of preventive strategies that may ultimately reduce burden~     and improve the productive quality of life for these individuals.~   "
137336|NCT01257867|"~     This study investigates the effects of daily use of lithia water on blood tests of neuronal~     oxidative stress, mood, and well-being. Lithia water is a type of pure spring water~     containing trace levels of lithium, which is a naturally occurring mineral. Neuronal~     oxidative stress is caused by normal chemical reactions in the human body that sometimes~     result in damage to brain cells. Participation in this study will last for 8 weeks and~     includes daily use of study water for drinking.~      The primary objective of this pilot study is to test the hypothesis that, in healthy male~     participants, daily use of lithia water will improve neurogenesis and antioxidant capacity~     as measured by serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress~     markers. Secondary objectives will include examining self-reported changes in mood,~     cognition, and well-being.~   "
137337|NCT01257854|"~     Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in~     children receiving hematopoietic stem cell transplantation.~   "
137338|NCT01257841|"~     The original study executed between 2002-2004 was an interventional trial in which 20,~     healthy, normal-weight female subjects were randomized to a four-day fast plus daily~     subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a~     placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid~     function, and cortisol secretion. The current study is a secondary analysis focussed on the~     placebo group which underwent a four-day fast. The study is looking at the effects of~     fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women.~     The hypothesis for this secondary analysis was that four days of fasting would augment~     levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived~     horomones, while suppressing secretion of inflammatory cytokines.~   "
137339|NCT01257828|"~     CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury~     worldwide. While there is evidence from the recently completed SpineNet prospective study~     that surgical decompression is an effective treatment for CSM, it is clear that many~     patients have remaining neurological impairment. While surgery is relatively safe,~     approximately 3% of patients maintain a neurological problem. Given this background and data~     from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong~     evidence to consider the potential benefit of adding a neuroprotective drug which aids in~     the treatment of patients with CSM whom are undergoing surgical decompression. Riluzole is~     FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar~     clinical features to CSM. Riluzole is currently under investigation for traumatic spinal~     cord injury. Given this background, there is a strong basis to consider studying the~     potential neurological benefits of Riluzole as a treatment to surgical decompression in~     patients with CSM.~   "
137340|NCT01257815|"~     This study evaluates a new investigational treatment regimen of three consecutive monthly~     doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for~     the first three months then two-monthly follow-up until 18 months in patients with visual~     impairment due to diabetic macular oedema.The aim of the study is to determine if this~     treatment regimen is effective and safe in these patients.~   "
137341|NCT01257802|"~     The purpose of this study it to determine whether the use of a gonadotropin releasing~     hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in~     women with rheumatic diseases will provide greater ovarian protection than placebo.~   "
137355|NCT01257620|"~     This exploratory study has been designed to determine the effect of the probiotic~     Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on~     clinical features, Quality of Life parameters (QoL), intestinal permeability and~     inflammatory markers of patients having positive serological evidences of Celiac Disease.~   "
137356|NCT01257607|"~     The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3~     to placebo for the treatment of the signs and symptoms of dry eye.~   "
137342|NCT01257789|"~     Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant~     learning curve. We report the results of a systematic training programme from a high volume~     bariatric center measuring the outcome by comparing the results with data from a consecutive~     series of 1000 fast track LRYGB.~      Method: Using a stepwise training programme the RY gastric bypass operation was divided into~     an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic~     surgeon without experience in upper GI surgery was mentored by an experienced bariatric~     surgeon. During 6 months full time fellowship 300 operations were performed.~      Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in~     which the mentor surgeon did the other part of the operation. In 110 patients the trainee~     performed both procedures. Two percent had peri-operative complications compared to 1% of~     1000 patients. All were repaired and had an uneventful recovery. Two percent had~     postoperative complications < 30 days compared to 2.8% in the clinic. In the trainees series~     there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for~     operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the~     clinic. Concerning time to discharge there was no difference between patients operated by~     the trainee and the standard of the clinic.~      Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery~     eliminates morbidity of the learning curve without affecting the volume.~   "
137343|NCT01257776|"~     A prospective, multicenter, open, randomized, parallel-group controlled study for two levels~     of dose.~      The study population will consist of 30 non-diabetic patients with critical chronic ischemia~     in at least one of the lower limbs (CLI) and without possibility of revascularization, from~     whom results can clinically be evaluable, of whom, 20 patients will be included in the~     experimental group (10 for each dose level) and 10 in the control group.~      In each of the two dose levels to be used in the study, 15 patients will be included, who~     will be randomized to the experimental group or the control group according to a~     distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each~     dose level, we will have 10 patients in the experimental group (treated with mesenchymal~     cells of adipose tissue) and 5 patients in the control group (conventional treatment)~   "
137344|NCT01257763|"~     The purpose of this study is to evaluate the safety and tolerability of an experimental~     device that introduces microscopic channels into the skin. Creating microscopic channels in~     the skin allows for better absorption of various medications applied to the skin, and this~     study will determine if the study device offers a tolerable method by which to introduce~     these holes. The study population will include 54 individuals, ages 18-74 years old, with a~     roughly equal distribution of skin colors. Each subject will have a total of three visits 24~     hours apart from one another. The study device will be applied at the Baseline and Day 1~     visits. At various timepoints before and after device application, skin assessments for~     irritation will be completed using a 7-point Skin Reaction Scale and photographs will be~     taken. Subjects will report pain associated with device application using a standardized~     pain scale. At the baseline visit, a member of the research staff will administer~     applications of the study device on the side of the subject's forehead, temple and the area~     below and to the side of the nose on randomly selected sides of the face. The side of the~     face at each location not receiving application of the study device will receive~     applications of a dummy device. Subjects will not be informed of which device is the study~     device and which is the dummy device. At the Day 1 visit, a member of the research staff~     will administer study device applications to the center of the subject's forehead. The~     subject will also self-apply the study device to the chin, under the instruction of the~     research staff member. At the Day 2 visit, final skin assessments will be made and the~     subject will be evaluated and treated for any persistent skin irritation. Differences in~     skin irritation between sites of study device application and dummy device application~     will be determined, as well as several other endpoints.~   "
137345|NCT01257750|"~     The purpose of this study is to determine the safety and efficacy of a drug [Pazopanib~     (Votrient)] as a treatment for corneal neovascularization. The cornea is the clear, central~     portion of the eye and neovascularization means blood vessel growth. The cornea is typically~     avascular, or without blood vessels. Corneal neovascularization in the cornea and can put~     vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction~     of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell~     deficiency can lead to corneal neovascularization. This major ocular complication can lead~     to corneal scarring, edema (swelling), lipid deposits, and inflammation that may~     significantly alter your vision. In addition, it worsens the outcome of potential future~     treatments, such as a corneal transplant. A corneal transplant is a treatment that many~     patients with severe corneal disease may ultimately need.~   "
137346|NCT01257737|"~     The present protocol is a treatment protocol to allow continued use of HPN-100 for the~     treatment of UCD subjects who complete 12 months of treatment in Study HPN-100-005,~     (NCT00947544), HPN-100-007, (NCT00947297), or HPN-100-012, (NCT01347073). Under this~     protocol, long-term safety will continue to be assessed.~   "
137347|NCT01257724|"~     The investigators have developed an online database called 'Synthesized HIV/AIDS Research~     Evidence' (SHARE), which is designed to support the use of research evidence by those~     working in the HIV/AIDS sector. This study will evaluate whether a full-serve version of~     SHARE increases the use of research evidence by community-based organizations as compared to~     a self-serve version. The full-serve version of SHARE consists of several components: 1)~     an online searchable database of synthesized research evidence relevant to HIV/AIDS , 2)~     periodic emailed updates, 3) access to user-friendly summaries and 4) peer-relevance~     assessments. The self-serve version consists only of a listing of relevant synthesized~     research evidence . The investigators will also interview participants in the study to~     obtain feedback about SHARE, how helpful it was in their work, why it was helpful (or not~     helpful), what aspects were most and least helpful and why, and recommendations for~     improving it.~   "
137348|NCT01257711|"~     Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal~     gastrectomy, however the debate one which is better remains unanswered. The aim of this~     study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal~     subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of~     life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal~     symptoms and reflux problems when compared to Billroth II reconstruction. Patients with~     resectable gastric cancer meeting the inclusion criteria will be consented and enrolled.~     Data on demographics, nutrition, gastrointestinal symptoms, and quality of life will be~     collected. They will be randomized after completion of distal subtotal gastrectomy to under~     go either Roux en Y or Billroth II reconstruction. Surgery data will be collected~     post-operatively.~      At 6 months follow up a repeat nutritional assessment using clinical and biochemical~     parameters will be carried out. The biochemical markers are part of routine follow up. The~     final assessment will be at the one year post surgery visit when by interview using EORTC 30~     questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and~     surgery data for recurrence will be repeated. At one year patients will also have upper~     gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis~     will be graded and esophageal reflux assessed as per Los Angeles classification. It is~     postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical~     symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a~     statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical~     difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for~     mortality and lost to follow up, a total of 160 subjects to be randomized equally will be~     recruited.~   "
137349|NCT01257698|"~     The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any~     effect on the duration of an intraocular gas bubble following pars plana vitrectomy.~   "
137362|NCT01257529|"~     The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a~     pregabalin controlled release tablet following either a low, medium, or high-fat evening~     meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate~     the safety and tolerability of a single dose of a pregabalin controlled release tablet~     following a low, medium, or high fat evening meal as compared to a single dose of the~     pregabalin immediate release capsule.~   "
137363|NCT01257516|"~     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
137364|NCT01257503|"~     A randomized controlled trial of a commercially available homeopathic cold remedy will be~     conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract~     infection will be randomized to receive either the homeopathic remedy or placebo. Parents of~     study children will administer 5 ml of the study medication up to 6 times per day as needed~     to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms~     (for up to the first 10 doses). In addition, parents will rate their child's overall symptom~     severity and functional status over the first 3 days of the cold. It is postulated that~     children receiving the active homeopathic remedy will have better symptom relief and that~     their symptom severity and functional status will improve more rapidly than those receiving~     placebo.~   "
137365|NCT01257490|"~     This study recruited cigarette smokers under supervision in community corrections (e.g.,~     probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12~     weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of~     bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The~     study was stratified on race such that equal proportions of African Americans and Caucasians~     were enrolled in the two study groups. It was hypothesized that smokers receiving intensive~     counseling will have higher quit rates compared to smokers receiving brief advice to quit.~   "
137366|NCT01257477|"~     An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current~     clinical practice setting.~   "
137367|NCT01257464|"~     The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV)~     inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes~     (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.~   "
137368|NCT01257451|"~     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly~     patients with Type 2 Diabetes Mellitus (T2DM).~   "
137369|NCT01257438|"~     The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular~     Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous~     outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the~     two predominant vascular access types - those with an AV graft and those with an AV fistula.~   "
137370|NCT01257425|"~     The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin~     pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the~     curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.~   "
137371|NCT01257412|"~     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in~     treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with~     diet and exercise alone.~   "
137372|NCT01257399|"~     To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug,~     marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool),~     in patients with Ulcerative Colitis in remission, treated for 48 weeks.~   "
137373|NCT01257386|"~     To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug,~     marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients~     with active ulcerative colitis (UC) treated for 8 weeks.~   "
137374|NCT01257373|"~     The goal of this study is to assess the long-term efficacy and safety of Firebird2~     Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in~     diabetes.~   "
137375|NCT01257360|"~     The objective of this trial is to obtain evidence that, in patients with RAS wildtype~     tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior~     to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy~     including two-drug combinations while reducing the toxicity compared to these two-drug~     regimens.~   "
137376|NCT01257347|"~     The purpose of this study is to test whether accurately measuring patients' adherence to~     their blood pressure medications with electronic pillbox monitors and then providing~     clinicians with this information can improve the clinical management of uncontrolled~     hypertension.~   "
137377|NCT01257334|"~     The objective of the current study is to investigate the efficacy, safety and tolerability~     of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on~     therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient~     glycaemic control.~      Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled~     patients (HbA1c > 10%)~   "
137378|NCT01257321|"~     Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and~     adenoidectomy in young children. According to previous studies, as much as 8 to 20% of~     patients will develop post operative respiratory complications requiring medical~     intervention. The pre-operative risk factors that could predict respiratory complications~     retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index.~     Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the~     first postoperative night in children with OSA. There is a debate regarding the~     post-operative duration and monitoring needed in children with OSA.~      Hypothesis:~      Pre-operative, operative and immediate post-operative parameters could predict post~     tonsillectomy respiratory complications.~   "
137379|NCT01257308|"~     We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung~     cancer.~   "
137380|NCT01257295|"~     Dietary fibers likely have a role in body weight management. They may increase satiety and,~     as a consequence, reduce energy intake during the next meal. There are, however, many~     different types of dietary fiber, which have diverse physical properties and can therefore~     impact these outcomes differently. It is, however, unclear whether dietary fibers with~     different properties lead to differences in energy intake during the next meal. The~     objective of this study is to study the effect of pectin in 4 different physicochemical~     states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal~     hormones, gastric emptying rate, feelings of satiety and the method of fiber~     supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum~     energy intake compared to low viscous and low gelling fibers.~   "
137381|NCT01257282|"~     This study includes patients with stable coronary artery disease without previously known~     myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial~     damage and its prognostic implication.~   "
137382|NCT01257269|"~     Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder~     characterized by thrombocytopenia as a result of platelet consumption, microangiopathic~     hemolytic anemia, occlusion of the microvasculature with von Willebrand~     factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a~     severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1~     motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13~     gene mutations.~      Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman~     syndrome patients varies considerably without an apparent genotype-phenotype correlation. In~     2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their~     family members to identify possible triggers of acute bouts of TTP, to document individual~     clinical courses and treatment requirements as well as possible side effects of long~     standing plasma substitution, e.g. alloantibody formation or viral infections.~   "
137383|NCT01257256|"~     The current study attempted to explore the relationships among stressors (cognitions of~     illness, socioeconomic status, social support, marital stressor, social stressor, etc),~     perceived stress level, and emotional reactions (anxiety and depression) of infertile~     patients and to propose the measurement and structural models of infertile aniexty and~     depression.~   "
137384|NCT01257243|"~     The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine,~     guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough~     treatment.~   "
137385|NCT01257230|"~     The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two~     doses of tiotropium bromide compared to placebo in adolescent patients with moderate~     persistent asthma. Efficacy and safety will be assessed by measuring lung function~     parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health~     care resource utilisation an on the number of adverse events.~   "
137386|NCT01256892|"~     To evaluate the impact of induction of labour at 38 weeks with the induction of labour at 40~     weeks in women with insulin dependent gestational diabetes mellitus on maternal and fetal~     outcome.~   "
137387|NCT01256879|"~     The purpose of this research is to see if non-drug ingredients in capsules and oral~     solutions affect how well drugs are absorbed. This is called bioequivalence. Medications~     taken by mouth, such as capsules and solutions, need to be absorbed into the body in order~     to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients~     that are called excipients or fillers. Excipients in the capsules and solutions can impact~     how much drug is absorbed into the body. This is called bioINequivalence. Capsules and~     solutions in this research contain the drug cimetidine. This drug is being used since it has~     high water solubility (can dissolve in water) and low ability to be absorbed.~   "
137388|NCT01256866|"~     The aim of this prospective randomized study is to compare the safety and efficacy of two~     strategies for sedation of critically ill patients submitted to mechanical ventilation:~     continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam.~     The two groups will be compared as to the incidence of of delirium, evaluated with the~     Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target~     sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18~     years or older intubated and mechanically ventilated for less than 48 hours prior to start~     of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample~     size is 146 patients (73 patients in each group)~   "
137389|NCT01256853|"~     This is a phase I, dose escalation trial of MVA-EBNA1/LMP2 vaccine across a pre-defined~     range of doses in patients in remission having had an EBV+ nasopharyngeal carcinoma (NPC).~   "
137390|NCT01256840|"~     The purpose of this study is to see whether people who have restricted the number of~     calories they eat for a long period of time, compared to normal-eating and obese people,~     have markers of cellular aging that look younger.~   "
137391|NCT01256827|"~     The purpose is to assess long term vision outcomes and disease status in patients with~     age-related macular degeneration previously treated with ranibizumab as participants in the~     Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.~   "
137392|NCT01256814|"~     The purpose of this study is to assess a new behavioral intervention to help how people~     living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new~     educational intervention can improve physical activity, sleep, mental wellness and quality~     of life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that~     those who are in the intervention group will practice more self-management skills than those~     in the control group.~   "
137393|NCT01256801|"~     The investigators want to develop a gene expression profile for the prediction of~     immunotherapy response of patients with metastatic breast cancer presenting malignant~     pleural effusion.~   "
137394|NCT01256788|"~     This study will look at patients with post-operative treatment of a meniscal tear or~     degenerative joint disease (degenerative arthritis). They will be randomized into one of~     three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are~     randomized into the injection group will receive a series of three injections (one a week~     for 3 weeks), then a booster injection at 6 months post-op. Several questionnaires will be~     given after the first set of injections, then again at a one year follow-up.~      The hypothesis is that patients receiving hyaluronic acid injections will have better pain~     and function scores as compared with placebo and no further treatment at all time points.~   "
137395|NCT01256775|"~     Peripheral arterial disease (PAD) is almost invariably associated with a generalized~     atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short~     term studies showed improvement of vascular reactivity and walking capacity in PAD patients~     by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the~     progression of atherosclerosis. We wished to assess whether the prolonged administration of~     a NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects~     the progression of atherosclerosis as assessed by carotid intima-media thickness (IMT).~      Four hundred forty two patients with stable intermittent claudication were enrolled in a~     prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg~     bid or its placebo for 6 months. The primary study outcome was the absolute claudication~     distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point~     was the change of the mean far-wall right common carotid artery IMT.~   "
137396|NCT01256762|"~     The purpose of this study is to evaluate the efficacy and safety of treatment with~     imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without~     bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have~     not received chemotherapy or have received one non-taxane based chemotherapy for metastatic~     breast cancer.~   "
137397|NCT01256749|"~     The fundamental reason for comparing the ability of the Frontal Sedline TM~     Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for~     burst suppression detection is to determine if a less expensive, less invasive and possibly~     more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced~     intraoperative burst suppression therapy (IBST) for cerebral protection.~   "
137398|NCT01256736|"~     The purpose of this study is to evaluate 1 year extension study of the efficacy and the~     safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with~     moderate to severe active RA and an inadequate response to current DMARD.~   "
137399|NCT01256723|"~     The main purpose of this study is to observe the incidence of major adverse cardiac and~     cerebrovascular events (MACCE), target vessel failure (TVF), target vessel revascularization~     (TVR) and stent thrombosis out to 5 years after the procedure in patients who underwent~     percutaneous coronary intervention (PCI) with everolimus-eluting stents for unprotected left~     main coronary artery (ULMCA) disease and lesions involving the ULMCA in Japan. The~     investigators will also establish a method of adjustment to the Japanese version of the~     SYNTAX score by conducting an assessment using the SYNTAX score recently reported in the US~     and Europe as well as the EuroSCORE, and by clarifying the differences of PCI procedures and~     treatment results in Japan with those reported in the US and Europe.~   "
137400|NCT01256710|"~     The purpose of the SJM International, Inc. sponsored Trifecta™ Durability Study, is to~     evaluate the long-term durability of the Trifecta™ valve.~   "
137401|NCT01256697|"~     Retinitis pigmentosa is a genetically determined disease consisting of progressive~     centripetal retinal degeneration starting in the rods outer segments. Its prevalence is~     1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all~     blindness]. The investigators tried to treat a non-progressive form of the disease [Fundus~     Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella bardawil~     composed of approximately 50% 9-cis β-carotene. The alga Dunaliella bardawil accumulates~     high concentration of β -carotene when grown under appropriate conditions. The β -carotene~     of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β~     -carotene.~      The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in~     human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night~     vision, as measured objectively by electroretinography (ERG) more than doubled in six~     patients tested. The visual field was also improved significantly.~   "
137402|NCT01256684|"~     The purpose of this Phase III trial is to confirm the efficacy of intravaginal~     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.~   "
137403|NCT01256671|"~     The purpose of this Phase III trial is to assess the long-term safety of intravaginal~     dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal~     atrophy aged 40 to 75 years.~   "
137404|NCT01256658|"~     This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT)~     and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a~     number of clinical malaria cases in children less than 5 years of age and the improvement of~     hemoglobin levels in the overall population.~   "
137405|NCT01256645|"~     The aim of this study is to determine, whether a liberal transfusion strategy is helpful to~     liberate patients from prolonged invasive mechanical ventilation.~      Patients who are difficult to wean according to the criteria by Boles et al [1] are limited~     by the capacity of their respiratory muscles.~      Improved oxygen delivery achieved by blood transfusions however is known to decrease the~     work of breathing [2] and thus in theory can improve weaning success [3].~      This study is designed as a prospective, randomized, open labeled blinded End-point~     evaluation to test the hypothesis that a liberal transfusion strategy decreases the time~     needed for weaning.~        1. Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M~          Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir~          J, 2007. 29(5): p. 1033.~        2. Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in~          chronically anemic patients with severe chronic obstructive pulmonary disease. Crit~          Care Med, 1998. 26(11): p. 1824.~        3. Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning~          from the ventilator. Anaesthesia, 1998. 53(2): p. 181.~   "
137406|NCT01256632|"~     The primary objective:~      *To measure the difference in the number of Ranibizumab therapies needed in 12 months in the~     Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD)~     negative group.~      Secondary Objective:~        -  To measure the mean change in visual acuity from Baseline to Month 12.~        -  To measure the mean change in central retinal thickness per OCT from Baseline to Month~          12~   "
137556|NCT01254552|"~     This study is aimed to answer the clinical question of the prevalence of myocardial scar in~     asymptomatic patients with type 2 Diabetes Mellitus with a special focus on the diagnostic~     efficacy of Xenetix® 350-enhanced 64-rows MDCT for the visualisation of the coronary~     arterial tree and secondarily for the assessment of myocardial viability when using Dotarem®~     enhanced-cardioMR as the gold standard examination.~   "
137407|NCT01256619|"~     The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as~     Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe~     for women. As a study from Thailand showed that the Marvelon to be effective and acceptable~     in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding~     and side effects were apparently lower in these Asian women . Although Marvelon was used in~     many countries but it's efficacy didn't reported among Iranian women.~   "
137408|NCT01256606|"~     The purpose of this study is to develop and evaluate a blood test for pregnant women for~     detection of fetal aneuploidy.~   "
137409|NCT01256593|"~     The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in~     medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in~     subjects treated with Lyrica will be monitored during the survey period, and whether an~     additional treatment outcome investigation and/or a post-marketing clinical study is~     required in the future will be determined.~   "
137410|NCT01256580|"~     Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular~     degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV)~     due to other causes. The limitation of this type of treatment is the necessity for frequent~     intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy~     in combination with photodynamic therapy can reduce the number of treatments needed with~     monotherapy while achieving similar visual results. There are ongoing multicenter trials~     evaluating combination therapy in patients with wet AMD but no similar trial for patients~     with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on~     patients with CNV not due to AMD.~   "
137411|NCT01256567|"~     The primary objective of this study is to investigate the safety and tolerability of the~     anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in~     Japanese participants with metastatic, or locally advanced breast cancer, with the aim of~     confirming the recommended dose of ramucirumab drug product (DP) in combination with~     docetaxel.~   "
137412|NCT01256554|"~     The goal of this clinical study is to learn the feasibility of using a single session of~     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural~     spinal cord compression.~   "
137413|NCT01256541|"~     To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas~     levels in patients requiring bowel evacuation, and also to determine the safety, efficacy,~     and patient preference of Kristalose as a bowel evacuant~   "
137414|NCT01256528|"~     The goal of this clinical research study is to learn if delayed-delayed breast~     reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic~     outcomes and result in fewer complications compared to the standard approach (reconstruction~     that is not started until radiation treatment is completed).~   "
137415|NCT01256515|"~     The goal of this study is to assess the immunogenicity of inactivated influenza vaccination~     (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different~     health management trainings.~   "
137416|NCT01256502|"~     The purpose of the study is to obtain clinical experience with the use of SERI® Surgical~     Scaffold for tissue support and repair in breast reconstruction.~   "
137417|NCT01256489|"~     The proposed study is intended to test the idea, based upon current knowledge of the biology~     and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis,~     and on the known effects of infliximab on matrix metalloproteinases, that infliximab therapy~     for such patients may reduce the likelihood of corneal ulceration, and hence extend the~     period of prosthesis retention and vision recovery.~   "
137418|NCT01256476|"~     Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4~     mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or~     mixed dyslipidemia.~   "
137419|NCT01256463|"~     The rapid scale-up of HIV care and treatment in resource-limited settings provides the~     opportunity to reach many HIV-positive individuals with prevention messages and~     interventions in care and treatment settings. However, HIV prevention is rarely incorporated~     into the routine care and treatment of people living with HIV, leaving missed opportunities~     to reach patients with critical interventions.~      This study will evaluate an HIV prevention intervention package for health care settings in~     sub-Saharan Africa. The HIV prevention intervention will be delivered to HIV-seropositive~     patients in HIV care and treatment clinics during all routine visits. Health care providers~     (HCPs) will deliver HIV prevention messages on correct and consistent condom use, disclosure~     of serostatus, partner HIV testing, adherence and alcohol reduction. They will also assess~     and treat sexually transmitted infections (STIs) and provide basic contraceptives and safer~     pregnancy counseling.~      Trained lay counselors (LCs) will deliver HIV prevention interventions in the clinics. LCs~     will be persons without medical training, many of whom will be PLHIV, who will be trained to~     provide HIV prevention counseling, promote HIV testing of partners and children (and provide~     HIV testing where allowed by national guidelines), and counsel HIV-positive patients on~     medication adherence and alcohol use.~      The prevention intervention package will be evaluated in HIV clinics in three sub-Saharan~     African countries: Kenya, Namibia, and Tanzania. This project will be a longitudinal~     group-randomized trial with 9 intervention clinics (3 per country) and 9 comparison clinics~     (3 per country). Two hundred patients per clinic (total N = 3600) will be followed for 12~     months. This evaluation will examine the effectiveness of the HIV prevention interventions~     delivered by HCPs and LCs on patient-level outcomes such as risky sexual behavior,~     disclosure of HIV status, partner HIV testing, alcohol use, HIV antiretroviral (ARV)~     medication adherence, STI treatment, pregnancies, and contraceptive use.~      In addition to the patient outcomes, the acceptability of the interventions and materials,~     as well as the feasibility of integrating the interventions into HIV care and treatment~     settings, will be assessed.~      Data will be collected via patient interviews, HCP and LC questionnaires, observations of~     HCP and LC patient visits, patient medical chart review, and review of clinic service data.~   "
137420|NCT01256450|"~     The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal~     film is effective and safe in the treatment of chronic low back pain (CLBP).~   "
137421|NCT01256437|"~     The investigators hypothesized that topical anti-inflammatory treatment could counteract the~     inflammatory reaction induced by EGFR'Is.~   "
137422|NCT01256424|"~     An effective and safe medical therapy would be most welcome to reduce the need for surgical~     interventions and related adverse events and psychological impact on patients with cervical~     cancer precursors. In this clinical trial, the investigators propose to evaluate the~     efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to~     moderate-grade CIN (grade 1-2).~   "
137423|NCT01256411|"~     The purpose of this study is to assess the long-term safety, tolerability and efficacy of~     LCZ696.~   "
137435|NCT01256255|"~     The investigators purpose is to prospectively characterize influenza infections over a 3~     year period in transplant patients using a registry system. The investigators plan to~     generate robust data on clinical features of upper and lower respiratory disease, antiviral~     therapy and its effects on disease outcome, as well as quantitative virologic data on~     shedding and antiviral resistance. The investigators also will study the long term sequelae~     of influenza infections and look at development of rejection.~   "
137424|NCT01256398|"~     This phase II clinical trial studies how well dasatinib followed by stem cell transplant~     works in treating older patients with newly diagnosed acute lymphoblastic leukemia.~     Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer~     cells by stopping them from dividing or killing them. Monoclonal antibodies, such as~     alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more~     than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may~     kill more cancer cells.~   "
137425|NCT01256385|"~     This phase II trial studies how well giving temsirolimus together with cetuximab works~     compared to temsirolimus alone in treating patients with recurrent and/or metastatic head~     and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor~     cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. It is not yet known whether giving temsirolimus together with cetuximab~     is more effective than giving temsirolimus alone.~   "
137426|NCT01256372|"~     This study investigates the effect of two dose-levels of AP214 on the prevention of (acute)~     kidney injury after cardiac surgery.~   "
137427|NCT01256359|"~     This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be~     randomly assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2~     IV and placebo given bd, or AZD6244 75mg bd daily with docetaxel 75mg/m2 IV. Docetaxel will~     be administered every 3 weeks for a maximum 6 cycles, but AZD6244/placebo may be continued~     beyond this, until disease progression. The objective is to assess whether the combination~     of AZD6244 with docetaxel is worthy of evaluation in a definitive randomised study, with the~     null hypothesis being that the combination has activity similar to that of docetaxel alone~     in this population. After consent has been obtained mutational analysis of tumour BRAF will~     be performed on archival tumour tissue, where this information is not already known, to~     assess eligibility for the study. If there is no archival tissue a fresh biopsy will be~     requested from the patient. A blood sample will also be taken for future genetic analysis.~     Once taking part in the trial patients will need to attend their oncology unit regularly for~     monitoring and the delivery of treatment. Patients will undergo complete physical~     examination at screening, on C1D1, C1D8, C1D15, C2D1, C2D8 and day 1 of every subsequent~     cycle. Blood for haematology, biochemistry and clotting will be taken at each of these~     visits. A 12 lead ECG will be performed at screening . Disease assessment will be by CT~     scanning using modified RECIST criteria after 9 and 18 weeks, then every 3 months until~     disease progression.~   "
137428|NCT01256346|"~     The goal of this study is to compare the time required for accurate heart rate measurement~     of the preterm newborn when using pulse oximetry versus electrocardiography leads.~   "
137429|NCT01256333|"~     Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this~     affection keep an elevate rate of death. The strategy of mechanical ventilation is more and~     more under definite protocol, following large strength randomized studies. Although, it~     doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure~     (PEEP) with improvement in patient's survival.~      The investigators proposed in this study to determinate the level of PEEP adjust to obtain~     the better arterial oxygen transport (TaO2). The investigators going to conduct a~     physiologic, observational, none controlled study. All patients hospitalized in intensive~     care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion~     criteria will be included. Primary objective is to looking for the optimum level of PEEP for~     TaO2.~   "
137430|NCT01256320|"~     The current research study has the potential to generate data that would provide solid~     clinical endpoints as to the impact of including eggs in a regular diet in individuals with~     peripheral arterial disease. Any one of three potential outcomes may be observed as a result~     of this study, and they are predicted as follows: 1) Egg consumption does not lead to a~     deterioration of indices of cardiovascular health; 2) Egg consumption improves indices of~     cardiovascular health; 3) Egg consumption worsens the indices of cardiovascular health.~   "
137431|NCT01256307|"~     There are two types of treatments depending on the severity of Obstructive Sleep~     Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard~     treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing~     excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4~     years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h),~     lifestyle measures, the bracing of mandibular advancement and / or possibly the head and~     neck surgery can be proposed. These treatments include side effects and their effectiveness~     is very controversial.Il therefore seemed interesting to test the impact of physical~     activity through a standardized training program to re personal effort on the development~     and improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15~     and 40 / h) The main assumption is that the ESR could eventually delay the initiation of~     treatment with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate~     OSAS and severe in patients who can not tolerate conventional treatment(CSF). The main~     objective of this biomedical research is to evaluate the effects of a program of REE in~     ambulatory index of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .-~     objectives specify 2AIR effects of REE on the quality of sleep (TxSLP) and daytime symptoms~     (EDS objective fatigue) on the one hand and the other on the metabolism (OV, SM, IR) and~     markers of LCR (inflammation, oxidative stress , endothelial function).~   "
137432|NCT01256294|"~     The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to~     branded tacrolimus (Prograf) in stable renal transplant patients.~   "
137433|NCT01256281|"~     The hypothesis of this study is:~      Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and~     painful crisis in the Emergency Department.~   "
137434|NCT01256268|"~     The purpose of this study is to:~        -  Test the safety of a new investigational drug called MK-8669 (ridaforolimus)~        -  Determine the maximum tolerated dose of MK-8669~        -  Determine the effectiveness of the maximum tolerated dose of MK-8669~   "
137448|NCT01256086|"~     The purpose of this study is to estimate the relative potency for bronchoprotective effect~     of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).~   "
137436|NCT01256242|"~     Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary~     surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment~     Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator~     cuff tendon and the humeral head providing further enhanced tendon to bone healing without~     adding any additional safety risk to the patient.~      Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical~     intervention of a torn rotator cuff and to obtain preliminary data to support the rationale~     for a subsequent pivotal clinical trial.~   "
137437|NCT01256229|"~     Children with special needs require complex, individualized therapy to maximize their~     long-term quality of life. One subset of children with special needs includes those with~     both developmental delays and deafness. Currently, there is little compelling evidence~     supporting the idea that cochlear implantation provides benefit to children that don't have~     the cognitive potential to develop normal speech and language.~      We will perform a prospective, randomized clinical trial to answer the question of which~     intervention provides more benefit to this population of children using validated,~     norm-referenced tests.~      Our long-term goal is to develop guidelines that may help when selecting a treatment for~     hearing loss in a child with developmental delays.~      This proposal is significant because children with special needs are deserving of evidence~     upon which to base treatment decision-making, but remain under-represented in the medical~     literature and are often not studied. This research is designed to meet the criteria for the~     National Institutes of Health road map because it will generate this type of objective~     evidence that can directly improve patient care.~   "
137438|NCT01256216|"~     The purpose of the data collection is to document the performance and clinical outcomes of~     the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.~   "
137439|NCT01256203|"~     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a~     non heated laser. The activation of the drug is done by illuminating abnormal areas using a~     fiber optic device. The fiber optic device is a very fine fiber (like fishing line) that~     permits transmission of light. By itself, porfimer sodium is inactive. However it becomes~     active when it is put in the presence of a light source such as sunlight, very intense~     indoor light, or laser. Therefore, the main risk with this therapy is that the skin will be~     more sensitive to light, and this sensibility can last up to 90 days. The skin reaction is~     similar to sunburn and is called phototoxicity.~      To date, no product on the market has shown protection against visible light, and therefore,~     no product has been demonstrated to protect against the skin phototoxicity to visible light.~     A sunscreen sold under the brand name Solar Protection Formula® SPF 60 in the United States~     contains ingredients that provide maximum ultraviolet (UV) protection, as well as a~     formulation that could provide visible light protection. The product could potentially~     prevent the skin phototoxicity due to visible light, the most frequently reported side~     effect in patients receiving PDT with porfimer sodium. Therefore, this study is designed to~     assess the efficacy of topical application of Solar Protection Formula® SPF 60 as skin~     protector against visible light-induced skin redness and swelling following injection of~     porfimer sodium. It will involve 17 to 20 human subjects in the United States for whom PDT~     with porfimer sodium is planned for the treatment of high-grade dysplasia in Barrett's~     esophagus (pre-cancerous change in the food pipe tissue), lung cancer, or cancer of the~     esophagus (food pipe).~   "
137440|NCT01256190|"~     A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and~     safety trial in subjects undergoing open liver resection surgery. The study will enroll 42~     eligible subjects and be conducted at 4 sites in the Netherlands.~   "
137441|NCT01256177|"~     The primary objective of this study is to evaluate the superior efficacy of quetiapine~     extended release(XR) mono-therapy, administered once daily compared to placebo, in the~     treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder~   "
137442|NCT01256164|"~     The purpose of this study was to characterize the safety and hemostatic activity of topical~     Fibrocaps in surgical patients when control of mild to moderate bleeding by standard~     surgical techniques was ineffective and/or impractical.~   "
137443|NCT01256151|"~     To assess if the sublingual tablet will have similar pharmacokinetics as the conventional~     tablet of alprazolam.~   "
137444|NCT01256138|"~     Allogene MSCs transplantation will be performed in patients with chronic liver diseases~     through portal vein by ultrasound guiding and therapeutic effects including short-term~     effects and long-term follow-up will be compared and investigated.~   "
137445|NCT01256125|"~     Allogene MSCs transplantation will be performed in patients with chronic liver diseases~     through peripheral vein and therapeutic effects including short-term effects and long-term~     follow-up will be compared and investigated.~   "
137446|NCT01256112|"~     The purpose of this study is to determine whether a nutrition and physical activity~     education program for families of overweight or obese adolescents with Down syndrome is more~     effective when behavioral lifestyle change strategies are added.~   "
137447|NCT01256099|"~     This study includes two sub-trials.~      In trial 1 patients suffering from insomnia but not meeting the criteria for depression are~     randomised to either therapist guided Internet-based CBT for insomnia or to a control group~     with a non-guided, brief self-help program that acts as a placebo control. The primary~     purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment~     and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the~     costeffectiveness of the treatment and to evaluate if the insomnia treatment has a~     preventive effect on future depressive episodes. Recruitment is done through mass media and~     includes all regions of Sweden. Initial assessment based on questionnaires and telephone~     interviews.~      Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done~     between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each~     respective treatment's effect on both insomnia and depression. The patients need for further~     treatment after the initial one will be measured and used as a secondary outcome.~     Recruitment is done through mass media but only citizens in the Stockholm area are included~     since the initial assessment are based on both questionnaires and telephone interviews as~     well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.~      Both trials will include health economic data and analysis. For the longer follow-up periods~     (1 and 3 years), registers will be used to analyse consumption of sleep medication and~     antidepressants as well as general health care utilization.~   "
137449|NCT01256073|"~     The trial is a multi-centre, open-label, safety and tolerability extension trial to the~     IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject~     pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia~     (AML) patients over the age of 60 years, in complete remission, and who are not eligible for~     allogeneic stem-cell transplantation. The dose given to the individual patient will be the~     same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for~     the 12 patients in an additional cohort.~   "
137450|NCT01256060|"~     Extensive data has been accumulated to suggest that central release of oxytocin is important~     for social cognition and function, as well as likely involved in anxiety modulation and~     repetitive behaviors. The principal investigators of this study have previously documented:~     1) an association between Autism Spectrum Disorder and a single nuclear polymorphism of the~     oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme~     immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in~     the treatment of social deficits and repetitive behaviors in adults with autism. A~     medication treatment targeting the core deficits of Autism Spectrum Disorder in childhood is~     highly valuable because it could influence the developmental trajectory and make further~     psychosocial interventions possible. In this context, we propose a small dose finding study~     to confirm that the dose used in the adult study is not more than the maximum tolerated dose~     in youth. `~   "
137451|NCT01256047|"~     The purpose of this study is to determine whether preoperative immunonutrition is effective~     on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.~   "
137452|NCT01256034|"~     The purpose of this study is to determine whether preoperative immunonutrition is effective~     on infectious complication and Th1/Th2 differentiation in patients with~     pancreaticoduodenectomy.~   "
137453|NCT01256021|"~     The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the~     treatment of children with cerebral palsy.~   "
137454|NCT01256008|"~     The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on~     depression and anxiety in breast cancer patients.~   "
137455|NCT01255995|"~     -  The purpose of this study is to determine the natural course of IOL in PXF,~        -  To demonstrate use of a clinical grading system for PXF,~        -  To strategize a way to prevent IOL dislocation, subluxation post operatively,~        -  To demonstrate intraoperative and long-term post-operative complications associated~          with phaco and PXF~        -  To suggest evidence-based ways to minimize these complications, by using capsular~          tension rings (CTR), specific IOL material or size~   "
137456|NCT01255982|"~     This study aims to study prospectively for 8 months a sample of bipolar patients with acute~     depressive episode in order to identify that factors associated with functional impairment,~     with especial attention to the presence of subsyndromal symptoms beyond the acute phase.~   "
137457|NCT01255969|"~     To evaluate if a model of intervention based on a low-grade physical program prescribed in~     the dialysis centre and performed at home can modify the functional capacity and quality of~     life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular~     events and vascular access failure in dialysis patients.~   "
137458|NCT01255956|"~     The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon~     catheter in the treatment of restenosis in bare metal stent.~   "
137459|NCT01255943|"~     The purpose of this study is to implement strategies for improved efficiency and waste~     reduction (Toyota Lean) and positive deviance, a social behavioral change process,~     utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA~     infection in outpatient dialysis care. In two outpatient dialysis units, dialysis unit~     healthcare staff will be educated in Toyota lean techniques and conduct periodic discovery~     and action dialogues to identify and implement care process changes to reduce infection.~     Outcomes to be monitored will include incidence of bloodstream infections and MRSA~     infections of all types. Data will be assessed at quarterly intervals using interrupted time~     series analysis.~   "
137460|NCT01255280|"~     The purpose of this study is to research a new behavioral treatment to reduce sexual~     risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal~     meth), and are at risk for HIV acquisition. This study proposes using a treatment based on~     our original pilot study that incorporates risk reduction and behavioral activation therapy.~     In order to help learn what types of treatment programs best help individuals who abuse~     crystal meth and engage in sexual risk-taking, we will compare our treatment to a control~     group. The treatment group will receive therapy incorporating behavioral risk reduction~     counseling with behavioral activation therapy to treat depression, helping individuals~     reengage in their life. The control group will receive the risk reduction counseling without~     the behavioral activation therapy. The current study hopes to explore the efficacy of this~     previous developed treatment in a two-arm pilot randomized controlled trial.~   "
137461|NCT01255267|"~     In this study, we evaluate the acute coronary syndrome patients to see if there is~     correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum~     adipokines level, and Clopidogrel responsiveness.~   "
137462|NCT01255254|"~     The aim of the study is to evaluate the effect of non-surgical periodontal therapy,~     consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the~     metabolic control of chronic periodontitis patients with type II diabetes mellitus.~   "
137535|NCT01254825|"~     The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to~     placebo when it comes to analgetic efficacy after Knee-Arthroscopy.~   "
137557|NCT01254539|"~     The purpose of this clinical trial is to assess the feasibility and the security of the~     intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment~     of Amyotrophic Lateral Sclerosis patients.~   "
137558|NCT01254526|"~     This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety,~     tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy~     regimens utilized in patients with locally recurrent or metastatic breast cancer.~   "
137602|NCT01253889|"~     The purpose of this study is to compare the effect of a 25% glucose solution given via a~     soother with or without facilitated tucking with a similarly administered water placebo~     (control condition) on infant stress responses during and immediately after a neonatologist~     performed ECHO (np-ECHO).~   "
137463|NCT01255241|"~     Lower Limb Deformities (LLDF) is a rather common infirmity among children. LLDF may result~     from various conditions such as trauma, tumors, infection, and dysplasia, congenital and~     metabolic abnormalities. It is assumed that correction of deformities by surgical procedure~     will improve ambulation and reduce energy expenditure.~      This prospective study will document the process of establishing the initial localization~     and magnitude of deformity through physical and radiological examination, kinetic and~     kinematical parameters, and measuring energy expenditure. The study will also document the~     type of surgical intervention undertaken to correct the deformity. Following a recovery from~     surgery, children's ambulation will be assessed again, by physical and radiological~     examination, by kinetic and kinematical parameters, and by measuring energy expenditure. A~     third series of exams will be performed four months later.~      It is expected that the surgical intervention will improve ambulation and reduce energy~     expenditure. This study aims at establishing a model enabling to assess ambulation and~     energy expenditure before and after surgical intervention. The results of the study may have~     practical implications on the decision and type of surgical procedures.~   "
137464|NCT01255930|"~     The aim of this study is to evaluate placenta maturity by the sonographic textures.The~     evaluation of placenta maturity by the sonographic textures is related to anticipative~     pregnancy and actual pregnancy . By analyzing this theory, the investigators want to bring~     up another objective and accurate analysis method in order to provide information for the~     evaluation of clinical trials.~   "
137465|NCT01255917|"~     This study is to understand the role of nerve growth factor(NGF) and other cytokines in the~     pancreatic fluid of patients with chronic pancreatitis.~      Hypothesis:~        1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is~          not only a mechanical problem~        2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is~          variably expressed in different morphological stages of CP and regulates the~          sensitivity of the peptidergic nociceptors and is upregulated in pancreatic~          inflammation.~   "
137466|NCT01255904|"~     The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal~     dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).~   "
137467|NCT01255891|"~     To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post~     radical prostatectomy patients with high risk pathological features for failure. To~     determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and~     clinical progression rate at 5 years.~   "
137468|NCT01255878|"~     Sleep bruxism (SB) is defined as a stereotyped movement disorder characterized by grinding~     or clenching of the teeth during sleep usually associated with sleep arousal. It might lead~     to abrasive tooth wear, hypermobility of teeth, tooth hypersensitivity, hypertrophy of the~     masticatory muscles and pain in the masticatory muscles.~      Diagnostic procedures include clinical evaluation, ambulatory monitoring sleep laboratory~     investigations and others. The clinical approach comprises the patient's history, orofacial~     examination, and tooth wear classification.~      There is no specific treatment for bruxism. Management of SB comprises psychological,~     orodental and pharmacological strategies.Orodental therapies, including soft vinyl mouth~     guards or stabilization bite splints, probably function more like protectors of the~     orofacial structures rather than actually diminishing bruxism.Drug treatment of sleep~     bruxism is controversial since different treatment strategies have resulted in suppression~     or exacerbation of this condition.~      Based on the current data, central primary efferents are the major drivers of bruxism.~     Therefore centrally acting agents such as antiepileptic drugs which also affect the sleep~     structure, might be effective on SB.~      In a case report of bruxism, anxiety and tremor, the authors suggested that anti-convulsant~     Gabapentine may be a useful treatment for patients with antidepressant-induced bruxism.~     However in the absence of definitive evidence, the appropiate treatment of SB is still a~     matter of debate.~      The objective of the present study was to compare the treatment efficacy of occlusal~     stabilization splint and Gabapentine on SB, using polysomnographically determined outcome~     measures for the quantification of sleep bruxism.~   "
137469|NCT01255865|"~     The purpose of this trial is the generation of clinical data required for a 510(k)~     submission to the FDA. The trial design reflects elements desired by the FDA. The trial is~     designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the~     content of premarket notification [510(k)] submissions for clinical electronic thermometers~     and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for~     basic safety and essential performance of clinical thermometers for body temperature~     measurement.~   "
137470|NCT01255852|"~     Severe intracranial atherosclerosis with concomitant stenosis is responsible for~     approximately 10% of all strokes. Retrospective studies have indicated that up to 50% of~     patients with a recently symptomatic intracranial stenosis experience recurrent ischemic~     events. Due to the high stroke risk, patients with high grade 70% symptomatic intracranial~     stenosis represent the main target group for endovascular treatment. Atorvastatin is widely~     used in the treatment of hyperlipidemia, especially after acute myocardial infarction.~     High-dose atorvastatin has been known to stop the progression of atherosclerosis and to~     decrease the levels of inflammatory markers. Several recent clinical trials have proved~     atorvastatin can reduce restenosis after stent implantation in coronary artery. But the~     feasibility of atorvastatin in preventing restenosis in patients with intracranial stenting~     has not been evaluated.The purpose of this prospective, randomized, single-blinded trial is~     to evaluate the effect of atorvastatin 80 mg daily in preventing restenosis and related~     vascular events in patients with intracranial stent implantation.~   "
137547|NCT01254669|"~     In the United States, Black women are more likely to die of cervical cancer than White~     women. In developing countries and globally, Haitian immigrant women are more likely to die~     of cervical cancer than any other women in the world. Studies have shown a disparity in~     parental acceptance of the HPV vaccine with parents of Black adolescent girls being less~     likely to accept and comply with HPV immunization schedules than Whites. The objective of~     this study is to increase HPV immunization rates in Haitian and African American adolescent~     girls. The investigator's hypothesis is that a validated behavior change mechanism,~     brief-negotiating interviewing (BNI), will effectively increase the proportion of mothers~     who give consent for their daughters' HPV vaccine, which will ultimately lead to higher~     vaccination rates, and increase knowledge of HPV infection and the vaccine in Haitian~     immigrant and African American mothers.~   "
137471|NCT01255839|"~     The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable~     cervices is well-established1. There are, however, potential side effects to prostaglandins,~     in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a~     mechanical ripening based on dilatation of the cervix as well as induction of production of~     endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane~     review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or~     prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in~     terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample~     size studies and substantive outcomes. Two later randomised studies compared mechanical~     ripening to PGE2 and found discrepant results regarding time from induction to delivery.~      The primary purpose of the present study was in a randomized design to compare the efficacy~     of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour,~     duration of birth and fetal outcome. Secondary analyses were to evaluate the results for~     various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm~     birth and intra uterine growth restriction.~   "
137472|NCT01255826|"~     The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as~     delivery room ventilatory management for preterm neonates at risk of respiratory distress~     syndrome in reducing their need for mechanical ventilation and ameliorating lung injury~     without inducing adverse effects compared with intermittent bag and mask ventilation.~   "
137473|NCT01255813|"~     The purpose of the proposed clinical study is to evaluate the use of an implanted~     Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of~     the pain associated with cluster headaches.~   "
137474|NCT01255800|"~     This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926~     in combination with cetuximab in patients with advanced head and neck cancer.~   "
137475|NCT01255787|"~     The purpose of this study is to assess the efficacy and safety of multiple doses of~     vortioxetine, once daily (QD), in participants with major depressive disorder.~   "
137476|NCT01255774|"~     The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular~     Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular~     (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF~     levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been~     shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of~     visual acuity in wet AMD, it is important to accurately measure anatomic response to~     treatments thereby enhancing the ability to understand patterns of response and predict the~     necessity for continued therapy.~   "
137477|NCT01255761|"~     Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a~     physician completed assessment (CDAI) to predict treatment success with subjects with~     moderate to severe rheumatoid arthritis~   "
137478|NCT01255748|"~     The purpose of this research study is to collect and analyze information from patients being~     treated with various forms of radiation therapy.~   "
137479|NCT01255735|"~     The primary objective of this study is to determine the impact of voice therapy on~     voice-related quality of life in children age 6-10 years old with apparent vocal fold~     nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument~     (PVRQOL)administered 4 weeks after completion of voice therapy.~   "
137480|NCT01255722|"~     The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol~     (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide~     (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability~     (quality and interpretability of images).~   "
137481|NCT01255709|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a~     stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the~     administered drug from the endogenous epinephrine, in healthy male and female adult~     volunteers.~   "
137482|NCT01255696|"~     A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.~   "
137483|NCT01255683|"~     Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS),~     the natural history and efficacy of this treatment modality has not been fully elucidated.~     Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural~     history of endoscopic improvement and quality of life (QoL) outcomes, following an oral~     steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical~     trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic~     grading, QoL, and olfactory function as well as defining the duration of improvement, in~     patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).~   "
137484|NCT01255670|"~     Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are~     required in addition to abscess drainage we perform a prospective, double blind,~     placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100~     patients are given penicillin and metronidazole and 100 patients get penicillin and placebo.~     Recovery and recurrence and analyzed.~   "
137485|NCT01255657|"~     This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and~     evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.~   "
137486|NCT01255644|"~     Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic~     stimulation of healthy B-cells. Identification of antigen(s) are relevant for the~     stimulation of CLL precursor cells is therefore of high interest. The investigators found~     recently evidence that a herpes virus is involved in this process of stimulation.~     Consequently, elimination of the antigenic stimulation of leukemic cells by this herpes~     virus may be expected to reduce or even inhibit propagation of leukemic cells. The~     investigators hypothesize that inhibition of CMV replication by a short course of antiviral~     treatment may reduce significantly proliferation rates of leukemic cells. To test this~     hypothesis, the investigators will treat 20 CLL patients with an antiviral drug for 3 months~     in a proof-of-concept clinical trial and leukemic cell counts measured before and after~     antiviral treatment. Antiviral treatment has the potential to treat the disease at its~     origin and therefore more efficiently than conventional chemotherapeutic regimens.~   "
137487|NCT01255631|"~     The most important prognostic indicator for the breast cancer patient is the axillary lymph~     node status. With the introduction of the sentinel lymph node biopsy, many women were spared~     the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes~     assessed with a low false negative rate. Approximately 30% of women who undergo ALND~     experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of~     motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women~     with early stage breast cancer would be able to avoid the dreaded morbidity associated with~     axillary lymph node dissections including lymphedema, decreased range of motion and pain.~     Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND.~     However, patients who undergo SLN still have a significant amount of pain with this~     procedure. There are few published studies which objectively assess the subjective and~     objective symptoms of SLND.~      Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of~     fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries,~     improvement of skin blood flow, healing of venous stasis ulcers, and reduction of~     postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and~     edema relief. PEMF devices are economical and disposable, and can be incorporated~     unobtrusively in standard post-op dressings. We have recently reported, in a double-blind,~     placebo-controlled study on breast reduction, that post-op PEMF therapy produced a~     significant decrease in pain and pain medication use, along with a concomitant decrease in~     IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF~     treatment, given in addition to standard of care, can reduce post-operative discomfort and~     morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND~     patients enrolled in the double-blind, placebo-controlled study will undergo standard~     surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil~     placed around the arm and the control group with a coil that delivers no PMF. We expect~     postoperative pain to be reduced in the PEMF-treated patients as well as improved arm~     mobility and strength. The use of PEMF might reduce the need for narcotic pain medications~     and their side effects of sedation, nausea, and vomiting. It may also reduce costs related~     to arm morbidity.~   "
137488|NCT01255618|"~     Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous~     bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and~     hemodynamics, and changes in newborn period.The aim of the present study is to investigate~     cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial~     exchange transfusion.~   "
137489|NCT01255605|"~     The purpose of this is to determine the impact of intermittent preventive treatment (IPT)~     with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant~     women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its~     implemented.~   "
137490|NCT01255592|"~     The purpose of this study is to investigate the effect of AZD5069 in patients with~     bronchiectasis.~   "
137491|NCT01255579|"~     New formulations of extrafine particles of long acting beta-2 agonists+inhaled~     corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung.~      Objectives.The aim of this study was to assess the effect on small airways obstruction of~     long-term treatments with two different LABA+ICS combinations in asthma.~      Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a~     4-week washout they were treated in a randomized cross-over design for 24 weeks with~     formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg~     and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period~     subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase~     III slope and closing volume (CV) during single breath washout test, and~     DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.~   "
137492|NCT01255566|"~     This investigation is a prospective, multi-institutional cohort study comparing the~     differences in health-related quality-of-life (HRQoL) improvements between subjects electing~     continued medical management for chronic rhinosinusitis and those electing medical~     management plus surgical intervention.~      Our hypothesis is 3 fold: 1. That patients electing continued medical management will have~     less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing~     medical management plus ESS for chronic rhinosinusitis will experience a larger improvement~     in health related quality of life (HRQoL)compared to patients electing medical management~     alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis~     will use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared~     to patients electing medical management alone.~   "
137493|NCT01255553|"~     This is a pilot study to determine if partial breast irradiation (PBI) limited to the region~     of the tumor bed following lumpectomy in patients screened with MRI provides historically~     similar rates of local failure, limited acute skin toxicity, late complications and cosmetic~     outcome when compared to patients treated with standard 3D-CRT to the whole breast.~   "
137494|NCT01255540|"~     The rationale of the present clinical trial is to study whether an invasive strategy in~     clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death,~     reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of~     life. The invasive approach involves coronary angiography with immediate evaluation for~     three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary~     artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older~     patients are commonly treated less vigorously than younger patients and the present~     guidelines are based on a considerably younger population.~   "
137495|NCT01255527|"~     Despite the advantages of autologous stem cell transplantation (ASCT) over conventional~     chemotherapy,1,2 the results of high-dose chemoradiotherapy in multiple myeloma (MM) are~     still unsatisfactory with a 6-year event free survival (EFS) of only 24%.~      Based on existing data, bortezomib-containing regimens are currently accepted at many~     centers as an induction treatment option for patients with symptomatic MM, particularly if~     it is planned to offer subsequent high-dose therapy with ASCT. So we will use~     bortezomib-containing regimens as induction prior to this novel conditioning regimen. The~     objective of the present study is to compare the toxicity and therapeutic efficacy of a new~     high-dose regimen using dose-escalation of BOR, BU and MEL for ASCT in the Korean patients~     with MM. The patients should be treated with bortezomib-containing regimens as an induction~     therapy before ASCT. We will specifically analyze (i) the efficacy of the conditioning~     regimen in improving the pre-ASCT status, response rate (ii) engraftment and~     transplant-related mortality (TRM) and (iii) the impact on survival including~     progression-free survival (PFS) and overall survival (OS).~      Triple combination of conditioning will enhance the response rate after ASCT, and will~     improve not only PFS, but also OS. We think that data from this study may further strengthen~     feasibility of BOR in conditioning prior to ASCT.~   "
137548|NCT01254656|"~     This is a study to assess long-term safety and efficacy of lersivirine in patients who have~     completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.~   "
137695|NCT01252680|"~     This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in~     healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A~     vaccines were evaluated.~   "
137496|NCT01255514|"~     Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone)~     induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50%~     and CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction~     chemotherapy followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR~     with near CR rate of sequential high-dose dexamethasone and response adopted PAD or VAD~     induction chemotherapy followed by ASCT is more than 60%, this combination will be accepted~     as active regimen that may be worth for investigating in phase III trial. But, if the CR~     with near CR rate of this regimen is lower than 50%, this has not a merit than VAD induction~     chemotherapy.~      Based upon the above assumption, this trial was designed by using Simon's optimal two-stage~     testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level,~     p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were~     observed, the trial will be continued. Accrual will be planned to a total of 190 patients.~     If total 106 or more patients were assessed as CR with near CR, sequential high-dose~     dexamethasone and response adopted PAD or VAD induction chemotherapy regimen will be~     accepted as active regimen. This design provides probability 0.05 of accepting drugs worse~     than p0 and probability 0.20 of rejecting drugs better than p1. If we assume that drop-out~     rate is 10%, total accrual patient will be 210.~      Patient characteristics and toxicity will be evaluated by descriptive methods. Progression~     free survival and overall survival (median value, 95% confidence interval) will be~     calculated by Kaplan-Meier method.~   "
137497|NCT01255501|"~     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic~     profiles of a novel therapeutic drug when administered to healthy volunteers.~   "
137498|NCT01255488|"~     To better understand the extent to which family nurse practitioners (FNPs) might use~     research abstracts in shaping their clinical decision-making under simulated conditions. A~     secondary point is to examine if and how FNPs might use full-text manuscripts (associated~     with the abstracts) if made available to them.~   "
137499|NCT01255475|"~     Previous studies have demonstrated a direct association between blood pressure level and~     cardiovascular risk. However in patients with heart failure this association is considered~     controversial. The aim of this study is to evaluate the effect of the reduction of blood~     pressure in patients with heart failure. The investigators will examine the effects of this~     intervention over mortality, quality of life, and cardiac function.~   "
137500|NCT01255462|"~     This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal~     LFG316 in patients with advanced age-related macular degeneration.~   "
137501|NCT01255449|"~     The aim of the present study will be to test the hypothesis that changes in within-breath~     total respiratory input impedance (Zrs) may provide an early evidence of obliterative~     bronchiolitis after allogeneic hematopoietic stem cell transplantation (HSCT). Before and~     after HSCT, Zrs will be measured by a modified forced oscillation technique (FOT) during~     spontaneous breathing both at baseline and 30 min after albuterol inhalation . Such~     technique may be particularly sensitive to small changes in lung mechanics observed in the~     early stages of peripheral airflow obstruction.~   "
137502|NCT01255436|"~     Objective: To test the primary hypothesis that SMS text messages delivered to patients via~     mobile phone can improve blood pressure within 12 weeks compared to usual care~      Design: Parallel group, randomized, controlled trial; the patient is the unit of~     randomization~      Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital~     and Private Outpatient Clinics near the Philippine General Hospital~      Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of~     essential hypertension, on maintenance blood pressure-lowering medications, who have daily~     access to a mobile phone in the household and know or live with someone who knows how to~     retrieve, read and reply to text messages using a mobile phone~      Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide~     information regarding hypertension; 2) remind patients to take their medications.~      Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic~     blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood~     pressure control rate and medication adherence.~   "
137503|NCT01255423|"~     The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1%~     compared with placebo applied four times a day in subjects with acute ankle sprains under~     'in-use' conditions, in particular with regard to pain relief.~   "
137504|NCT01255410|"~     People who are infected with human metapneumovirus (HMPV) may develop upper and lower~     respiratory illnesses. Children are particularly sensitive to HMPV infection. This study~     will evaluate the safety and immune response of an HMPV vaccine in healthy adults,~     HMPV-seropositive children, and HMPV-seronegative infants and children.~   "
137505|NCT01255397|"~     The purpose of this experiment is to test the feasibility of a minimally interventionist~     protocol for young couples with male factor infertility, which addresses the cause of~     infertility for these couples which is the inability of the sperm to fertilize the~     egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist~     and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based~     on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the~     uterus on the same day as the aspiration.~   "
137549|NCT01254643|"~     This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese~     girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable~     immune response to all human papillomavirus (HPV) strains contained in the vaccine. The~     success criterion for the primary analysis requires that point estimates for seroconversion~     rate be greater than 90% for all 9 HPV types.~   "
137550|NCT01254630|"~     This is a randomized, double-blind, placebo-controlled study to assess the safety and~     tolerability of V212 when administered to adults with solid tumor malignancy (STM) or~     hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes~     zoster (HZ) in adults with STM or HM, as compared to placebo.~   "
137574|NCT01254318|"~     This will be a retrospective study that includes retrospective chart reviews at major~     institutions across Canada. The intent of the study is to generate both regional and~     national incidence data for non-Candida invasive fungal infections (IFI) in high risk~     participants. The study will include participants receiving stem cell transplant and high~     dose chemotherapy treatment for leukemia.~   "
137506|NCT01255384|"~     Pregestational diabetes (PGD) during pregnancy may be associated with an increased rate of~     spontaneous abortions, intrauterine death and congenital anomalies among the offspring.~     Although the prevalence of congenital anomalies among the offspring of diabetic mothers is~     reduced as a result of the improvement of the glycemic control in the early pregnancy, the~     rate of congenital anomalies is increased and there seems to be an increased rate of~     neurodevelopmental disorders including some fine and gross motor deficits as well as~     increased rate of inattention and/or hyperactivity. In gestational diabetes, that develops~     in the second half of pregnancy (past the period of major organogenesis), there seems to be~     no increase in the rate of major congenital anomalies but there are some developmental~     disorders in the offspring.~      The exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia,~     hyperketonemia ext), is known to cause increased oxidative stress and significant changes in~     gene expression as observed in several experimental diabetic models. We hypothesize that~     diabetic environment may also cause long lasting epigenetic changes. It is therefore our~     purpose to evaluate these possible epigenetic changes and correlate their presence with the~     degree and time of onset of diabetes, (i.e. whether from the beginning as in PGD or in the~     second half of pregnancy as in GD), the degree of oxidative stress and with the~     neurodevelopmental outcome of the offspring. Diabetic pregnancies will be compared to a~     similar number of normal pregnancies in all parameters studied.~   "
137507|NCT01255371|"~     In the well recognized context of HIV infection chronicity, it is now crucial to identify~     and evaluate effective, well tolerated and affordable second line regimen in resources~     limited countries where patients often change treatment after a long period of viral~     replication while on first line regimen.~      This multicentre international, randomized, non-blinded phase III trial aim to demonstrate~     the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily~     intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily~     intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level~     (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also~     allow to evaluate the optimum moment for instituting the second-line treatment.~   "
137508|NCT01255358|"~     Multi-centre, single arm, open label, 6 months, phase II study to evaluate the effect of~     Ery-Dex in improving Central Nervous System (CNS) symptoms in patients with Ataxia~     Teleangiectasia (AT). The study consists of a screening period (max duration of 30 days) and~     a treatment period (duration 6 months).~   "
137509|NCT01255345|"~     The purpose of this study is to investigate the frequency and severity of chronic pelvic~     pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population~     2,4 million), Denmark, in relation to selected factors, such as basic demographic and~     clinical factors, health related quality of life, physical activity and abnormal muscular~     findings in the pelvic area.~   "
137510|NCT01255332|"~     We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st~     line treatment of immune thrombocytopenic purpura (ITP) patients with moderate~     thrombocytopenia.~      If this eradication treatment is revealed effective on ITP patients with more than 30X109/L~     of platelet, it would be valuable treatment especially for young ITP patients with mild to~     moderate thrombocytopenia.~   "
137511|NCT01255319|"~     To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide,~     fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell~     transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).~   "
137512|NCT01255306|"~     The aim of the study is to evaluate the influence of silicone oil on thickness of the~     retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following~     pars plana vitrectomy.~   "
137513|NCT01255293|"~     The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke~     versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.~   "
137514|NCT01255098|"~     This plan is to develop blood culture or to measure diagnostics of Immuno Magnetic Reduction~     assay in the first stage.~   "
137515|NCT01255085|"~     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,~     subjective appetite and glycemic response.~   "
137516|NCT01255072|"~     This double-blind, controlled and randomized study intents to investigate the antidepressive~     response of rTMS on the elderly population.This is the first neuronavegated pulse intensity~     corrected study of rTMS in elderly depressed patients.~   "
137517|NCT01255059|"~     To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin~     Population.~   "
137518|NCT01255046|"~     The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an~     add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).~   "
137519|NCT01255033|"~     The purpose of this study is to compare the ability of two peripheral and non invasive~     devices to detect hypoxic events during one-lung ventilation and during the early~     postoperative period. One device measures regional cerebral oxygenation and the other~     muscular oxygenation. These two devices are compared to non invasive arterial saturation~     (SpO2), which is the gold standard.~   "
137520|NCT01255020|"~     The prospective, double blind randomized, parallel control, and multi-center clinical trial~     will evaluate the safety and efficacy of α-keto acid with restricted protein diet on~     protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD)~     patients.~   "
137551|NCT01254617|"~     This phase I trial studies the side effects and the best dose of lenalidomide when given~     together with cetuximab in treating patients with colorectal cancer or head and neck cancer~     that has spread to other places in the body and usually cannot be cured or controlled with~     treatment. Biological therapies, such as lenalidomide, use substances made from living~     organisms that may stimulate the immune system in different ways and stop tumor cells from~     growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways~     by targeting certain cells. Giving lenalidomide together with cetuximab may be a better~     treatment for colorectal cancer or head and neck cancer.~   "
137552|NCT01254604|"~     This study will test the hypothesis that preservative-free tafluprost (MK-2452) is~     non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular~     pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle~     glaucoma or ocular hypertension.~   "
137521|NCT01255007|"~     1. Primovist-enhanced Magnetic resonance imaging (MRI) and Diffusion Weighted MRI (DW-MRI)~          is superior to Multidetector Computed axial Tomography (MDCT) in the detection of~          colorectal liver metastases. Fatty changes in the liver after chemotherapy treatment~          likely reduces the chances of seeing metastatic lesions on CT especially when the~          lesions are small (<10 mm). When compared with CT, Primovist-enhanced MRI and DW-MRI~          have the potential to provide higher contrast resolution enabling better detection of~          colorectal liver metastases following chemotherapy.~        2. Primovist-enhanced MRI and DW-MRI are superior to CT in assessing and predicting~          treatment response of patients with colorectal liver metastases to chemotherapy.~          Primovist-enhanced MRI by providing superior resolution may provide improved accuracy~          in metastatic lesion margin detection thereby providing higher accuracy in estimating~          tumor response based on size criteria. DW-MRI provides information indirectly about~          tumor composition and therefore is likely to be superior to MD-CT in assessing~          treatment response.~      Two groups of patients will be analyzed. The second group consists of patients with~     colorectal liver metastases who are to go for chemotherapy prior to surgery for metastases~     resection. This group will be CT and MRI scanned prior to chemotherapy and after~     chemotherapy. The first group of patients will consist of those patients who have already~     received chemotherapy and are likely to have surgery to resect liver metastases. This group~     will have only one set of scans done 4-6 weeks prior to their operation. The pathology of~     the resected metastases and CT and MRI images will be analyzed and compared.~   "
137522|NCT01254994|"~     To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients~     with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with~     ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group~     (n=55). The HBV DNA level, liver function and survival condition of the patients were~     observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment~     efficacy were also identified.~   "
137523|NCT01254981|"~     To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in~     the treatment of unselected patients with ischaemic heart disease.~   "
137524|NCT01254968|"~     The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow~     in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of~     walking training - walk forwards and backwards, with closed and open eyes.~   "
137525|NCT01254955|"~     Organ transplant patients and staff members at the Transplant Institute have received~     pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by~     haemagglutination inhibition according to the clinical guidelines and policy, respectively.~     This study retrospectively assessed the immune response after vaccination.~   "
137526|NCT01254942|"~     This is a parallel Randomized Controlled Trial comparing two different delivery modes of~     post hip fracture management—a specialized Fracture Follow-up Clinic versus Usual Care~     alone. The Fracture Follow-up Clinic will focus on bone health and fall risk factors. The~     investigators will evaluate the effect of the clinic and exercise program on mobility and~     falls. The investigators primary hypothesis is that within the first year following a hip~     fracture, older adults who are assessed in the B4 Clinic and prescribed an exercise program~     will have significantly improved Short Physical Performance Battery (SPPB) scores compared~     with participants who receive usual care alone.~   "
137527|NCT01254929|"~     The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP~     bone scan to determine if one is better for diagnosing bone metastases.~   "
137528|NCT01254916|"~     Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in~     both incidence and prevalence. It calls into attention consensus about diagnosing, assessing~     symptoms and treatment of patients with CRS. Therefore a validated Danish measure of~     health-related quality of life in sinonasal disease is needed.~      Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and~     reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical~     analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and~     Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the~     SNOT-22.~      Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the~     initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation~     between the initial scores and the retests scores. Kappa was calculated for each item with a~     mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant~     difference in the subscales.~      Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and~     researches as a patient-reported measure of outcome in sino-nasal disorders such as~     rhinosinusitis and nasal polyposis.~   "
137529|NCT01254903|"~     The goal of this clinical study is to learn the feasibility of using a single session of~     radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural~     spinal cord compression.~   "
137530|NCT01254890|"~     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can~     control the disease in patients with AML or MDS. The safety of this drug combination will~     also be studied.~   "
137531|NCT01254877|"~     The proposed randomized clinical trial will investigate a novel pharmacotherapy for~     hazardous drinking, HIV-infected men and women, using the 5-HT3 antagonist ondansetron. The~     investigators predict that participants who are treated with active doses of ondansetron~     will reduce their drinking more and show better HIV treatment participation and progress~     compared to participants who are treated with placebo. This study will provide important new~     safety and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy~     in HIV-infected persons.~   "
137532|NCT01254864|"~     Objectives:~      Primary Objectives:~      To compare two two-stage treatment strategies for patients with castrate resistant prostate~     cancer that has progressed after treatment with Abiraterone Acetate.~   "
137533|NCT01254851|"~     This study is a non-blinded randomized controlled trial. Consenting participants will be~     randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they~     will be given a goal number of steps to take on each post-operative day) following~     in-patient gynecologic surgery.~   "
137534|NCT01254838|"~     The purpose of this study is to evaluate the safety and CTL reaction of novel peptide~     vaccination for advanced renal cell carcinoma~   "
137536|NCT01254812|"~     TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after~     abdominal surgery. The method is often applied ultra-sound guided.~      In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed.~     This includes injection of local anesthetics at four sites on the abdominal wall, aiming at~     the best possible spread of the nerve block.~      Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the~     sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge,~     clinical investigations regarding the effect on the muscles of the abdominal wall has never~     been executed.~      Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have~     to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore~     it would be inappropriate if the motor nerves supplying these muscles were too, affected by~     the nerve block.~      Our clinical experience has so far not given us suspicion or indication that the motor~     nerves become blocked, although these nerves are situated in the same muscle layer as the~     sensory branches.~      Hence the investigators would like to examine on healthy, male subjects, whether application~     of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and~     expiratory pressure. Our study hypothesis is:~      There is no clinically relevant difference in the spread of results of pulmonary tests (peak~     flow et.c.) before and after application of bilateral dual TAP-block.~   "
137537|NCT01254799|"~     This study aims to test the effect of Doxycycline in treatment of uterine bleeding during~     the use of injectable contraception that contains one hormone progesterone only.~   "
137538|NCT01254786|"~     Video-assisted thoracoscopic surgery (VATS) is usually performed using well-collapsed lung~     is essential for optimum surgical visualization and resection. However, one lung ventilation~     (OLV) is associated with deleterious impaired oxygenation secondary to the increases in~     shunt fraction.1 There are different approaches for the recruitment of the non-dependent~     lung (NL) during OLV such as the selective application of continuous positive pressure~     ventilation (CPAP) or high frequency positive pressure ventilation (HFPPV) to the~     non-dependent lung.2-4 These strategies may improve arterial oxygenation and reduce shunt~     fraction,2-4 However, the use of high CPAP levels impaired the surgical conditions during~     thoracotomy.2-3 On contrary, the application of HFPPV either to both lungs5or to the~     non-dependent lung permits adequate surgical conditions during thoracotomy.4 The~     investigators hypothesize that the application of volume-controlled HFPPV to the~     non-dependent lung during OLV for video-assisted thoracoscopic surgery may provide better~     surgical field and adequate oxygenation than the use of CPAP 2 cm H2O.~      The investigators will evaluate the effects of the selective application of conventional one~     lung ventilation, HFPPV, or CPAP 2 cm H2O to the non-dependent lung on surgical field~     conditions, and arterial oxygen and carbon dioxide tensions (PaO2 and PaCO2, respectively)~     during OLV in the patients scheduled for video-assisted thoracoscopic surgery.~   "
137539|NCT01254773|"~     This study in individuals with mild to moderate Alzheimer's Disease is designed to~     assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce~     brain amyloid load as measured by positron emission tomography (PET) scans.~   "
137540|NCT01254760|"~     The purpose of this trial is to evaluate and compare the clinical performance of two~     multifocal contact lenses.~   "
137541|NCT01254747|"~     The purpose of this 4-week dispensing trial is to evaluate and compare an investigational~     soft contact lens worn on a daily disposable basis with three other soft contact lenses also~     worn on a daily disposable basis.~   "
137542|NCT01254734|"~     RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and~     neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical~     trial studies how transoral robotic surgery works in treating patients with benign or stage~     I-IV head and neck cancer.~   "
137543|NCT01254721|"~     The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy~     compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation~     of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using~     the last observation carried forward method.~   "
137544|NCT01254708|"~     Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among~     solid organ transplant recipients. The most important risk factor for the development of IA~     (which is associated with disease and death) is colonization of the organism in the~     respiratory tract.~      Azoles are used to prevent the development of IA. Puffers containing antifungal medication~     can be used to treat the lungs without the need to worry about the medication interactions &~     side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is~     limited by the patients' tolerating this medication that may cause cough, nausea &~     contraction of the air pathways.~      The lipid preparation is better tolerated and has longer dosing interval than inhaled~     amphotericin B. The investigators propose a pilot study to determine the long-term safety of~     inhaled AmBisome administration of drug and generate the preliminary data on the~     effectiveness of this drug to prevent aspergillus colonization.~   "
137545|NCT01254695|"~     Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population.~     The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has~     over the last decade given hope to patient failing conservative treatment. Some patient do~     not have optimal continence after SNS-therapy. This study aims to identify optimal~     stimulation parameters - that will improve the functional outcome of SNS-therapy thru a~     double blinded randomized cross-over study.~   "
137546|NCT01254682|"~     The primary objective of this study is to evaluate the efficacy and safety of Ostenil~     application (1% hyaluronan) after arthroscopy of the wrist.~   "
137553|NCT01254591|"~     RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography~     (PET/CT) scanning before surgery, may help measure the extent of disease.~      PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with~     non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and~     neck cancer.~   "
137554|NCT01254578|"~     This phase I clinical trial is studying the side effects and the best dose of lenalidomide~     after donor bone marrow transplant in treating patients with high-risk hematologic cancer.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different~     ways and stop cancer cells from growing.~   "
137559|NCT01254513|"~     The objective of this study is to evaluate the feasibility of two different chemotherapy~     protocols with adjusted doses for patients aged 75 and over who often have medical problems~     other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly.~     In both cases, chemotherapy is combined with prednisone. The protocol will be considered~     feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks).~      Additionally to this primary objective, efficacy will also be evaluated for both protocols~     as well as tolerance to treatment, quality of life and evolution of geriatric data.~   "
137560|NCT01254500|"~     Event-related potentials (ERPs）has the advantage of excellent temporal resolution on~     measuring real-time neural activities that reflect to higher level cognitive processes. A~     research project related to lesion studies in which patients with cognitive function~     impairment and communication disorder will be recruited as participants to examine their~     impairment as well as residual abilities by using ERPs. Hopefully, expected findings will~     provide further analysis based on the patterns of neural activities revealed by both~     patients and normal controls should be able to provide important evidence toward building~     the cross-linguistic theory. The findings also have applications on diagnostic and~     evaluation for patients with brain lesions for clinical application with communication~     disorder.~   "
137561|NCT01254487|"~     The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix~     (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.~   "
137562|NCT01254474|"~     Monophasic action potential (MAP) recording plays an important role in a more direct view of~     human myocardial electrophysiology under both physiological and pathological conditions. The~     MAP method represents a very useful tool for an electrophysiological research in cardiology.~     Its crucial importance lies in the fact that it enables the study of the action potential~     (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this~     potential with all the organism variables what can be particularly helpful in the case of~     arrhythmias.~      Hundred and fifty patients will be included to explore mapping capabilities in cardiac~     chambers in patients suffering from regular or fibrillating tachycardia's with the following~     inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular~     fibrillation or patients at high risk of sudden cardiac death at a total of 50 patients iii)~     Junctional tachycardia at a total of 50 patients. We will focus on cardiac activation~     (depolarization and repolarization) in this population.~   "
137563|NCT01254461|"~     The primary purpose of this study is to determine whether the treatment with AZD1981 will~     affect the pharmacokinetics of pravastatin.~   "
137564|NCT01254448|"~     This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619~     in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects~     with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and~     tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to~     receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and~     pharmacokinetics.~   "
137565|NCT01254435|"~     Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The~     investigators hypothesise that visualisation of the colonic mucosa on extubation may be~     improved by changing patient position as follows: left lateral position for the right colon,~     supine for the transverse colon and right lateral position for the left colon(fixed~     positioning). The investigators aim to validate our hypothesis by performing a randomised~     control study, comparing mucosal visualisation in patients placed in the 'routine' positions~     at the discretion of the endoscopist with visualisation in those placed in the above~     described positions. The hypothesis is that fixed positioning confers an advantage.~   "
137566|NCT01254422|"~     The purpose of this study is to evaluate the safety and immunogenicity of Phase III lots of~     the CYD dengue vaccine in a pediatric population in Malaysia.~      Primary Objectives:~        -  To describe the safety (in terms of solicited and unsolicited adverse events) of the~          CYD dengue vaccine in all subjects after each dose.~        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and~          post-Dose 3~   "
137567|NCT01254409|"~     The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and~     the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.~   "
137568|NCT01254396|"~     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar~     pharmacokinetic properties when given with food and without food.~   "
137569|NCT01254383|"~     This study will evaluate if an orally disintegrating tablet of sildenafil will have similar~     pharmacokinetic properties as the conventional tablet of sildenafil.~   "
137570|NCT01254370|"~     The purpose of this study is to compare:~        -  the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in~          subjects with glaucoma or ocular hypertension and ocular surface disease.~        -  the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan~          Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.~   "
137571|NCT01254357|"~     As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument~     was developed to study the outcomes of burn survivors in the 19-30 year old age group. This~     workgroup has come together to re-examine the data collected during the previous study and~     determine next steps in understanding the recovery for this population.~   "
137572|NCT01254344|"~     The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium~     compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site~     infection following elective colorectal surgery in Chinese adults. This study is designed to~     demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in~     this participant population.~   "
137573|NCT01254331|"~     This open-label, multi-center study in a local environment will evaluate the safety and the~     effect on disease activity with regard to reduction in signs and symptoms over 6 months of~     treatment in patients with moderate to severe active rheumatoid arthritis who experienced an~     inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an~     intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in~     combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.~   "
137575|NCT01254305|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of~     Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder~     (MDD).~   "
137576|NCT01254292|"~     The primary objective of this study is to evaluate user satisfaction and tolerability in~     young women (18-29 years of age) using the LCS12 compared with young women using a COC~     (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use~     of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional,~     extension phase. Safety data only will be collected during the extension phase of the study.~      Secondary objectives are to observe the tolerability, discontinuation rates, adverse event~     profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]),~     and bleeding profiles with the two birth-control methods. Additionally, data on missed~     tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system~     (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician~     satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal~     threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of~     subjects) will be collected. Finally, in the COC group, information will be collected on the~     psychosocial impact of missed or delayed pill intake.~   "
137577|NCT01254279|"~     The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial~     (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic~     Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or~     after docetaxel and to document the overall safety of cabazitaxel in these patients.~      Please note that in each country, patient recruitment will end when cabazitaxel becomes~     commercially available.~   "
137578|NCT01254266|"~     The major problem in the treatment of morbidly obese children is the long term maintenance~     of the reduced weight. Maintenance-focused interventions have not been studied enough in~     adolescents with morbid obesity, neither in regard to conservative methods of weight~     reduction, nor in regard to bariatric surgeries.~      This study will investigate the effectiveness of an integrative, multi-disciplinary~     inpatient program for promoting long-term weight maintenance in children with morbid~     obesity. The program will be studied in two perspectives: as a conservative treatment, as~     well as an 'envelope' for bariatric surgeries including a pre-operational preparation phase~     and a post-operational follow-up.~      The investigators hypothesize that program participants will maintain weight significantly~     better than the proportion known in the literature.~   "
137579|NCT01254253|"~     The purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining~     CTCA with low-dose stress-only SPECT vs. coronary angiography for detecting haemodynamic~     relevant coronary lesions; and second to determine the effects of PCI on cardiac perfusion,~     cardiac function and quality of life in patients with CTO lesion in left anterior descending~     (LAD) coronary artery.~   "
137580|NCT01254240|"~     This is a double-blind prospective randomized monocenter study comparing the efficacy of two~     phototherapy ultraviolet spectra on pruritus (itching) of inflammatory skin diseases. 40~     patients per treatment, in total 80 study participants.~   "
137581|NCT01254227|"~     This study will evaluate the efficacy and safety of deferasirox in combination with~     deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due~     to chronic blood transfusions.~   "
137582|NCT01254214|"~     The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress~     Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered~     mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and~     improve quality of life for people waiting for a kidney transplant. Participants will be~     randomly assigned to tMBSR or to a support group emphasizing communication skills and~     selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly~     teleconference calls, and conclude with an in-person meeting. Participants will complete~     questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will~     complete additional questionnaires. Participants will complete sleep diaries and wear~     Actiwatches (similar to a wristwatch) for one week before programs start, and when programs~     end, to measure sleep. Participants will provide saliva samples, over 3 days before programs~     start, and again when programs end, to measure salivary cortisol, an indicator of stress.~     tMBSR participants will record daily home meditation practice.~   "
137583|NCT01254201|"~     Dry eyes are a very common complaint. In some patients, we can identify the reason for the~     dryness; however, in others the dryness has no clear cause. Dryness can lead to eye~     irritation, redness, and sometimes changes in vision. Fibromyalgia is a condition of chronic~     pain that is poorly understood but seems to have a component of altered sensory processing.~     People with fibromyalgia tend to complain of dry and irritated eyes at a higher rate than~     the general population. We plan to evaluate patients with dry eye symptoms for abnormalities~     in sensory processing and in their autonomic nervous system. We hope to learn about possible~     relationships between dry eye symptoms and fibromyalgia in order to better understand and~     treat these conditions.~   "
137584|NCT01254188|"~     This study will further investigate the safety and efficacy of nilotinib in newly diagnosed~     chronic myeloid leukemia patients in the chronic phase~   "
137585|NCT01254175|"~     Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory~     diseases in infants and children. This study will evaluate the safety and immune response of~     an HPIV3 vaccine in infants and young children.~   "
137586|NCT01254162|"~     To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum~     production on the forehead of healthy male volunteers.~   "
137587|NCT01254149|"~     The primary purpose of this study is to determine whether topical ophthalmic anesthetics~     lower the intraocular pressure in the eye.~   "
137588|NCT01254136|"~     This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839~     in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast~     cancer.~   "
137589|NCT01254058|"~     The purpose of this study is to determine whether rapid eye movements called saccades are~     impaired in glaucoma, a neurodegenerative disease of visual pathways.~   "
137590|NCT01254045|"~     The purpose of this study is to determine whether the medication oxytocin is an effective~     and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving~     socially appropriate behaviors and reducing social anxiety.~   "
137591|NCT01254032|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial~     impact on a patient's life. However, the impact of COPD is currently under-recognised and,~     as a result, COPD is under-treated. An exacerbation of COPD is a major element that causes~     poor quality of life and loss of productivity. Therefore, minimizing the frequency of~     exacerbations is a short term treatment goal in COPD management and could improve Quality of~     Life (QoL) significantly in all severity groups of COPD.~      Although the use of spirometry for the determination of disease severity in COPD is~     supported by guidelines, a lung function test alone does not provide a measurement of the~     overall impact of COPD on health status and is not generally available especially in primary~     care centre. Therefore, a standardised and effective dialogue between patients and~     physicians in a consultation could address the impact of COPD on a patient's QoL in this~     situation.~      The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple,~     self-administered questionnaire designed to assess the condition of patients and overall~     impact of COPD, and to improve patient-physician communication. It has been proven that the~     CAT has good repeatability and discriminative properties which suggest that it is sensitive~     to treatment effects at a group level. The CAT score with its better ability to assess the~     impact of COPD on patients, suggests potential to predict a significant change in COPD~     status such as acute exacerbations of COPD.~      Since the CAT is designed to assess the impact of COPD on the patient by measuring overall~     impairment, it has better correlations with other instruments, such as the Clinical COPD~     Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory~     Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with~     FEV1 (Forced Expiratory Volume in One Second).~      While the CAT shares some similarities with other questionnaires, there are several~     important differences. For example, the SGRQ is substantially longer than the CAT, is~     complex to administer and requires the use of a computer for scoring. The CAT is designed to~     provide a holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea~     scale only measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the~     CAT is the only validated, short and simple assessment test which can provide a holistic~     measure of the impact of COPD on patients, ensuring both the physicians and the patients~     gain the understanding needed to manage COPD optimally.~      QoL is defined as an individual's perception of their position in their life in the context~     of the culture and value systems. Therefore, the extent of understanding of the~     questionnaire might be influenced by language and ethnicities. Since the validation findings~     so far have been based on data from the US and Europe, PACE may provide better quality of~     data across ethnic groups given that mainly Asian subjects will participate in this study.~      PACE is designed to evaluate whether the CAT has a high predictive value in detecting~     subsequent exacerbations of COPD. If so, this result might enable both patients and~     physicians to better target and optimise management. The primary objective is to evaluate~     the predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary~     objectives are to evaluate the predictability of the CAT to have moderate to severe~     exacerbations or time to the first exacerbation, to identify risk predictors for COPD~     exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC~     dyspnea scores. An experimental objective is to evaluate the correlation between the CAT~     score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD~     exacerbation over the following treatment period adjusting for demographics, MRC scores,~     lung function parameters, medical history, and therapy history.~      PACE is a multicentre, prospective, observational study designed to evaluate the~     predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study,~     subjects continue taking their regular prescribed treatment. Investigators are free to make~     medication adjustments where required. Eligible subjects will have a clinic visit every 8~     weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List~     (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in~     between clinic visits to collect data for the ECL.There is no follow-up period.~      550 male and female outpatient subjects will be recruited for PACE to obtain approximately~     300 exacerbation events. This study will capture the winter periods in Australia, China,~     Korea and Taiwan, when incidence of exacerbations is at its peak.~      Statistical analysis will be performed on subjects' data to derive the PACE end-points.~   "
137594|NCT01253993|"~     There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in~     middle childhood are associated with an increased risk for substance abuse in adolescence.~     However, the exact underlying mechanism of this increased risk is unknown. It is likely that~     a biopsychological vulnerability in some aggressive children and children with DBD makes~     them liable to substance use and abuse. The investigators hypothesize that deficient~     decision making is such a biopsychological factor. In this study the investigators aim to~     test the latter hypothesis by investigating the decision making ability in a group of~     adolescents with DBD with and without substance use disorders. Decision-making is assessed~     with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it~     factors uncertainty, reward and punishment. The GT is specifically designed to assess~     impaired decision-making in individuals who are unable to learn from their mistakes and make~     decisions that repeatedly lead to negative consequences. This characteristic may be common~     to individuals with externalizing disorders such as DBD, psychopathy, and substance use~     disorders.~   "
137595|NCT01253980|"~     Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits~     to healthcare facilities, especially amongst children. There is no evidence in animals and~     no good evidence in humans that the use of early antibiotics improves the clinical outcome~     of paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate~     whether the use of early antibiotics affects the clinical course of children with~     pneumonitis following paraffin ingestion.~   "
137596|NCT01253967|"~     The purpose of this hospital based study is to estimate the proportion of rotavirus~     gastroenteritis in children < 5 years of age in Romania.~   "
137597|NCT01253954|"~     The incidence of invasive candida infection (ICI) in critically ill patients is increasing~     day by day. The crude mortality of IFI in ICU could be as high as 25%-75% depending on their~     age, underlying conditions, and so on. Candida albicans was by far the predominant species~     in most countries, causing up to two thirds of all cases of invasive candidiasis. However, a~     shift toward non-albicans Candida species has been observed. Although the studies of ICI~     cause universal attention recently, there is still no large-scale, multi-center~     epidemiological research in China focusing on ICI in critically ill patients, therefore we~     conducted a large-scale multi-center observational study of IFI in critically ill patients~     named China Scan (CHINA Survey of Candidiasis in ICU) to assess the current incidence,~     mortality, pathogen spectrum, management, and risk factors for ICI in China ICUs.~   "
137598|NCT01253941|"~     Rehabilitation and physical therapy strategies targeting extra pulmonary manifestations of~     Chronic Obstructive Pulmonary Disease (COPD)are far from being well defined. Studies,~     performed in healthy subjects using threshold breathing device [a simple method to increase~     inspiratory muscle load] have shown that ventilatory muscle overactivation during loaded~     breathing may prime reactive oxygen species (ROS) production, thus initiating an~     inflammatory response that results in elevation of pro-inflammatory cytokines, particularly~     IL_6. Increase of cytokine IL_6 in turn, elicits a cascade of systemic responses, involving~     hormone like glucoregulatory mechanisms, lipolysis and fat oxidation, as well as control of~     breathing.~      Thermal mud bath therapy has been acknowledged for its antioxidant and anti-inflammatory~     effects in several chronic diseases. However, it is not considered among treatment options~     of chronic pulmonary disease. Previous experimental studies indicate that trace elements of~     thermal treatments, particularly iodide and bromide, may positively intervene in the setup~     and maintenance of active state in skeletal muscle. These findings suggest that in COPD~     patients these elements may improve the loading and endurance of respiratory muscles and~     therefore blunt ventilatory muscle overactivation and the ensuing inflammatory cytokine~     response.~      In this study the investigators want to test two major hypotheses. First, that mud bath~     therapy reduces systemic inflammatory processes in COPD patients, increases respiratory~     muscle endurance and normalizes the ventilatory response. Second, that the increase in~     systemic inflammation after IRB exercise is blunted by mud bath therapy.~   "
137599|NCT01253928|"~     Non diabetic patients on renal replacement therapy are prone to changes in body composition~     with an increase in visceral fat and muscle wasting all favoured by the insulin resistant~     state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are~     the most powerful insulin sensitisers available in clinical practice which also have~     anti-inflammatory properties. Their use has been associated with significant and favourable~     changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest~     that glitazones may attenuate muscle wasting in renal failure.~      The goal of this study was to examine in non diabetic ESRD patients the effects of~     pioglitazone on inulin sensitivity and protein metabolism as determined by the~     hyperinsulinemic euglycemic clamp and on changes in body composition as determined by~     anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined~     changes in abdominal visceral and sub-cutaneous fat.~   "
137600|NCT01253915|"~     This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in~     the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450~     patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1~     ratio to ensure that 400 patients will treat at least one moderate to severe migraine with~     the study drug.~      Patients will be randomized to one of two treatment groups and be provided with either an~     active or placebo dispenser.~      All patients will administer study drug for 10 seconds to each nostril when experiencing a~     qualifying headache. Patients will assess their pain and other migraine-related symptoms in~     a patient diary. If a patient still has pain and/or any other symptoms after the initial~     dose then the patient may opt to take 3 more doses to treat the headache.~      Each patient's participation in the study may last up to 56 days or once the patient treats~     4 headaches with the study drug, whichever occurs first.~      There will be a total of 2 scheduled clinic visits:~        -  Visit 1 Screening/Randomization~        -  Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache~          or after the end of the 56-day treatment period, whichever occurs first)~   "
137601|NCT01253902|"~     This study evaluated the ocular surface tolerability of the prostaglandin analogues~     bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution~     0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients~     previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.~   "
137603|NCT01253876|"~     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,~     inositols might have beneficial effects on weight control and blood pressure management.~     Most studies in this regard have been conducted on postmenopausal or premenopausal women and~     there are few studies on female youths. Therefore, we are going to determine the effects of~     soy consumption on the weight, waist circumference and blood pressure in overweight and~     obese female youths. This was a cross-over randomized clinical trial which was conducted in~     2010 in Isfahan on overweight or obese young female youths. After three weeks run-in,~     females were randomly assigned to consume a diet containing caw's milk or a diet in which~     only one glass of soy milk was substituted; each one for six weeks. Random sequencing~     generated in SPSS was used for allocating females in different group randomly. Patients were~     not blinded because they had to use soy milk in one period of trial and use caw's milk in~     another period.~   "
137604|NCT01253863|"~     The purpose of this study is to determine the accuracy of preoperative clinical examination~     in penetrating injuries~   "
137605|NCT01253850|"~     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,~     when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy.~     However, adherence among HIV-infected young people is suboptimal, and few interventions are~     available to help adolescents adhere to treatment.~      The first phase of the study is an intervention development phase, which includes conducting~     interviews with 40 HIV-infected youth for input on the adaptation of the approach. The~     information obtained from the qualitative interviews is used to adapt the Life-Steps~     intervention (designed by our group for HIV-infected adults) to be responsive to the needs~     of HIV-infected adolescents, with acceptability of topics and content, and feasibility of~     intervention delivery to be tested in an open pilot trial.~   "
137606|NCT01253837|"~     The recombinant human fusion protein L19TNFα was created with the intention to overcome the~     systemic toxicity of TNFα by directly targeting it to tumor tissues. Tumor-targeted L19TNFα~     would result in high and sustained intralesional bioactive TNFα concentrations.~   "
137607|NCT01253824|"~     The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and~     LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration~     cycle.~   "
137608|NCT01253811|"~     This trial will be conducted in Asia, Europe and the United States of America (USA).~      The aim of this clinical trial is to investigate long-term safety of rFXIII when~     administered for prevention of bleeding episodes in children aged between 1 and 6 years with~     congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760~     (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years~     dependent on when recombinant factor XIII will be commercially available in subject's~     respective country for use in children of 1-6 years of age.~   "
137609|NCT01253798|"~     The purpose of this study is to determine which group exercise one should choose when hip~     osteoarthritis patients have undergone hip replacement surgery. To determine this, we want~     to answer the following research question:~      Are there differences in function and muscle strength in osteoarthritis patients who conduct~     group training either on land or in water in the rehabilitation phase following hip~     replacement surgery?~   "
137610|NCT01253785|"~     Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.~   "
137611|NCT01253772|"~     Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples~     during cardiac surgery.~   "
137612|NCT01253759|"~     This is a report of 10 years results of combined Transpupillary thermotherapy (TTT)~     treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal~     melanomas.~   "
137613|NCT01253746|"~     The Genetics of Neural Tube Defects Study at the University of Miami: The University of~     Miami John P. Hussman Institute for Human Genomics is looking for families to participate in~     research to identify the genetic and environmental factors that contribute to Neural Tube~     Defects (NTD). Our research goal is to better understand the genetic and environmental~     causes of both open NTD, like spina bifida and anencephaly, and closed NTD, like~     lipomeningocele and tethered cord. This will eventually lead to more accurate genetic~     counseling and risk assessment, improved treatments, and better prevention methods. Any~     individual with a diagnosis of NTD and his/her selected family members can participate, if~     willing. Participation is free. Travel is not required. Participation involves reading and~     signing a consent form, providing a blood sample, a family and medical history interview,~     and granting the research staff permission to review the medical records of the~     individual(s) with NTD. We maintain the highest standards of confidentiality for all~     families. If interested, please contact Maria Ciliberti, the study coordinator, at~     1-877-686-6444 (toll free) or directly at 305-243-4360, or by email Mciliberti@med.miami.edu~     . Please visit our web site at www.hihg.org for more information.~   "
137614|NCT01253733|"~     UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self~     management web and text message based program on health-related self-efficacy and frequency~     of adolescent-conducted healthcare interactions. We hypothesize that users of the program~     will demonstrate greater gains between baseline and 8 month measures of health related~     self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care~     comparison group.~   "
137615|NCT01253720|"~     UC San Diego researchers conducted a study to develop and evaluate an internet and text~     message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors.~     We hypothesized that those study participants randomized to the intervention will~     demonstrate greater reduction in BMI-z score as compared to the control group.~   "
137616|NCT01253707|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 337 in~     subjects with advanced solid tumors.~   "
137617|NCT01253694|"~     Treatment with Ranibizumab of the residual diabetic edema in patients with failed response~     to Bevacizumab.~   "
137618|NCT01253681|"~     To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well~     tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial~     ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in~     combination with carboplatin and paclitaxel is safe and well tolerated.~   "
139062|NCT01234662|"~     To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural~     anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain~     after elective cesarean section.~   "
137619|NCT01253668|"~     This is a phase II study of an investigational agent, brivanib, in patients with refractory~     metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of~     brivanib in renal cell carcinoma, and explore the activity of this drug in this population~     to determine whether imaging and molecular features of the tumors can be used to predict~     response. Approximately 30 people with advanced kidney cancer will be enrolled on this study~     at the University of Pennsylvania.~   "
137620|NCT01253655|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-05212365 in healthy volunteers~   "
137621|NCT01253642|"~     This phase II trial studies how well giving phenelzine sulfate together with docetaxel works~     in treating patients with prostate cancer that is growing, spreading, or getting worse after~     first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work~     better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together~     with docetaxel may kill more tumor cells.~   "
137622|NCT01253629|"~     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective~     in treating the behavioral symptoms of Fragile X Syndrome.~   "
137623|NCT01253616|"~     This is a proof-of-concept study designed to provide feasibility information on the clinical~     use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.~     The study is expected to give preliminary efficacy and safety information.~   "
137624|NCT01253603|"~     This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free~     patients with mild to moderate persistent asthma.~   "
137625|NCT01253590|"~     The purpose of this study is to assess whether it is possible and acceptable to monitor~     patients at a distance who experience a condition called atrial fibrillation after their~     cancer surgery. Some patients have no other clinical reason for staying in the hospital~     after cancer surgery except in order to control their heart rhythm. Being able to send these~     patients home earlier and monitor them at a distance from their home can be good for their~     quick recovery. Studies have shown greater quality of life and patient satisfaction when~     patients are monitored at a distance for conditions like atrial fibrillation, however cancer~     patients have not been studied.~   "
137626|NCT01253577|"~     The purpose of this study is to assess the safety and efficacy of the Propel mometasone~     furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients~     with Chronic Sinusitis (CS).~   "
137627|NCT01253564|"~     This open-label study will assess the safety and efficacy of RO5185426 in previously treated~     metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a~     dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.~   "
137628|NCT01253551|"~     The purpose of this study is to confirm the absence of a clinically relevant interaction~     between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the~     treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV~     infection.~   "
137629|NCT01253538|"~     The purpose of this study is to examine effective methods of preventing the transmission of~     HIV from mother to child during pregnancy, labor, and delivery. This is one part of the~     three-part PROMISE study. This study will be conducted at resource-limited locations in~     Africa and other parts of the world where women typically receive a short course of highly~     active antiretroviral therapy (HAART) during pregnancy and where formula feeding (FF) is~     standard.~   "
137630|NCT01253525|"~     Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in~     combination with paclitaxel.~   "
137631|NCT01253512|"~     This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national,~     escalating dose, pilot study comparing two doses of THR-18 to placebo when administered to~     patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator~     (tPA).~      The study hypothesis is that THR-18 will be safe and well tolerated in subjects suffering~     acute ischemic stroke and treated with Thrombolysis.~   "
137632|NCT01253499|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     TRx0037 after multiple doses in elderly volunteers.~   "
137633|NCT01253486|"~     This study will determine whether the psychological and physical benefits of expressive~     writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac~     rehabilitation~   "
137634|NCT01253473|"~     The main objective of the study is to see if using anti-inflammatory to patients with airway~     disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than~     using these treatments in patients with loss of lung tissue. Symbicort plus~     ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with~     airway predominant COPD.~   "
137635|NCT01253460|"~     The goal of this clinical research study is to learn if sapacitabine given in combination~     with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The~     safety of this drug combination will also be studied.~   "
137636|NCT01253447|"~     This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients~     with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
137637|NCT01253434|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in~     healthy Japanese male volunteers.~   "
137638|NCT01253421|"~     The purpose of this study is to evaluate the effects of a single low dose of the D2/D3~     antagonist amisulpride on reward processing. More generally, this study will test the role~     of dopamine (a naturally occurring brain chemical) in depression.~      Hypotheses:~      Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve~     performance in a behavioral task assessing learning from feedback and (2) boost activation~     in reward-related brain regions.~   "
137907|NCT01249885|"~     The purpose of this study is to examine pacifier sucking habits among children, and to~     assess implications of the oral habit - for example malocclusions and drooling. The effect~     of pacifier sucking will be recorded and compared to pacifier type and frequency of use.~   "
137639|NCT01253408|"~     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no~     effective and safe medications approved for the treatment of abdominal pain associated with~     bowel symptoms in IBS. This study will investigate the effects of an approved medication,~     Dronabinol, on the movement of food through the stomach and colon in subjects with a history~     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).~      Dronabinol is a synthetic medication (a medication made in a laboratory) related to the~     active ingredient of cannabinoid or marijuana. Dronabinol is approved by the Food and Drug~     Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing~     chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in~     appetite and weight gain.~      The hypothesis in this study is that dronabinol will slow down the movement of food through~     the colon, and that this effect is regulated by the genes controlling the body messengers~     (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same~     messengers that are present in the gastrointestinal tract and pain nerves.~   "
137640|NCT01253395|"~     Randomized equivalency trial of the effects of strength training compared to aerobic~     exercise on pain severity in adults with fibromyalgia.~   "
137641|NCT01253382|"~     The primary objective of this study is:~        -  assess the safety and tolerability of ecallantide in paediatric patients for acute~          attacks of HAE~      The secondary objectives are:~        -  evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for~          acute attacks of HAE~        -  assess the efficacy of ecallantide in paediatric patients treated for moderate to~          severe acute attacks of HAE~   "
137642|NCT01253369|"~     Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel~     formation. This drug has been used in other cancer research studies and information from~     those studies suggests that pazopanib may help block proteins that are important for the~     growth, invasion, and spread of cancer cells.~   "
137643|NCT01253356|"~     The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing~     major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30~     days compared with standard care alone, while maintaining acceptable safety with respect to~     vascular accesss-related complications.~   "
137644|NCT01253343|"~     Violence and aggression on pediatric psychiatry units has led to staff and patient injuries~     and even deaths around the country. In an effort to improve safety, the investigators have~     developed a method (with the Brief Rating of Child and Adolescent Aggression) of identifying~     children and adolescents at a higher risk for aggression and violence on the units. In order~     to improve this prediction, the investigators plan to study salivary hormones in low risk~     children and high risk children. The salivary hormones to be studied include cortisol,~     testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to~     improve the investigators current ability to predict the severity and type of pediatric~     aggression and violence on the inpatient units by combining information from the Brief~     Rating of Child and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale~     (Vitiello et al., 1990), and salivary hormones.~   "
137645|NCT01253330|"~     The purpose of this randomized crossover study is to determine the efficacy of participant~     designed medication reminders on asthma control, asthma related quality of life,and~     medication adherence. In addition, this study will provide data regarding the usage,~     usability, acceptability of an online system designed for creating text message reminders.~     It is hypothesized that the teens receiving text message reminders will report having~     greater quality of life related to their asthma, a reported increase in the control of their~     asthma, and increased adherence to their medication regimen compared to those teens that are~     not receiving the text message reminders.~   "
137646|NCT01253317|"~     The investigators are recruiting children for a research study using a medication known as~     IGF-1 (mecasermin or INCRELEX) to see if it improves the health of children with Rett~     syndrome (RTT). To participate in the study your child must be female, between the ages of 2~     to 12 and have a genetic diagnosis (MECP2 deletion or mutation) of Rett Syndrome. As you may~     know, there is no treatment for this illness. Currently, the standard management of Rett~     syndrome is supportive, which means attempting to prevent complications and treatment of~     symptoms.~      This study involves testing an investigational drug, which means that even though IGF-1 is~     approved by the Food and Drug Administration (FDA) for use in children, it has not been used~     before to treat Rett syndrome specifically. Information from this research will help~     determine whether the drug should be approved by the FDA in the future for the treatment of~     Rett Syndrome.~      There are five major goals to this study:~        1. As one of the features of Rett Syndrome is unstable vital signs, the investigators are~          trying to determine if IGF-1 has any effect on normalizing your child's pulse, blood~          pressure and breathing pattern. During PHASE 2, a device called BioRadio® will be used~          to monitor vital signs in a non-invasive way. This information will be recorded and~          stored on the accompanying laptop. Before starting PHASE 2, the investigators would~          like to beta-test the BioRadio® in PHASE 1. As such, the investigators may ask you to~          try using the BioRadio® with your child to test the fit and the performance of the~          equipment. Should you choose to enroll your child in PHASE 2, the investigators will~          then ask that your child wear the BioRadio® for two hours, on two consecutive days~          every four weeks.~        2. The safety of IGF-1 in children with Rett syndrome. The study personnel will ask you to~          complete a medication diary and side effect reporting form on a regular basis. They~          will assist you in completing this by telephone interviews. Your child will undergo 2~          lumbar punctures performed at the bedside in the clinical research facility. In~          addition, laboratory tests will be performed throughout the study to evaluate the~          safety of IGF-1. These will be blood tests similar to those provided in routine~          clinical care. Your child will undergo regular non-invasive comprehensive physical~          examinations including neurological and eye examination, tonsil evaluation,~          electrocardiograms (ECG), measurement of height, weight and head circumference.~        3. IGF-1 may improve your child's behavior, communication and speech. In order to measure~          this, the investigators will evaluate your child once during each month of treatment~          with neurodevelopmental assessments and a neurological exam. All of the tests used~          during these evaluations are non-invasive. the investigators will also ask you what~          your impressions are about her behavior and day-to-day activities through a structured~          parental interview and various questionnaires.~        4. We will examine your child's cortical function through use of electroencephalography~          (EEG) in conjunction with presentation of visual and auditory stimuli. EEG is a~          non-invasive way of recording the electrical activity of your child's brain by applying~          a net of electrodes to her scalp. Through this we gain insight into how neural function~          correlates to the progression of behavioral abnormalities seen in individuals with RTT.~          By understanding how this electrical brain activity produces the abnormal behaviors~          seen in RTT, we will be better able to identify whether or not treatment with IGF-1~          affects the way the brain communicates with the body.~        5. Children with Rett Syndrome are often unable to regulate their body temperature and~          will sometimes experience flushing in their cheeks or have exceptionally cold hands~          or feet. The Qsensor® is a non-invasive device worn on a fabric bracelet that~          continually measures your child's perspiration level and body temperature. We would~          like to use the Qsensor® to determine whether or not IGF-1 improves your child's~          ability to regulate her body temperature. As such, we ask that your child wear the~          Qsensor® during each study visit. This wrist-worn sensor has been demonstrated to be~          safe and comfortable but may cause a slight gray discoloration where the sensor~          contacts your child's skin. This discoloration will go away in less than a day. The~          Qsensor® is not waterproof, therefore may not be worn in the shower or while your child~          is washing her hands. If you believe the device is broken, please contact the study~          team immediately.~   "
137647|NCT01253304|"~     The primary purpose of this study is to help answer the following research questions, and~     not to provide treatment for any condition:~        -  To evaluate how much of the study drug (LY2189265) is in the blood of participants with~          varying degrees of liver impairment compared to those with normal liver function.~        -  To assess the safety of LY2189265 and any side effects that might be associated with~          it.~   "
137648|NCT01253291|"~     The objective of this study is to evaluate the safety and tolerability of 48 weeks~     subcutaneous dosing with LY2127399 for patients who have participated in a prior LY2127399~     clinical study. At the end of the 48 week treatment period, patients will participate in a~     24 week follow up period. Additional follow up after week 72 may continue to assess B cell~     recovery.~   "
137649|NCT01253278|"~     The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The~     primary purpose of a patient's participation in this study is to help answer the following~     research question(s), and not to provide treatment for diabetes:~        -  The safety of LY2393910 and any side effects that might be associated with it following~          2 weeks of doses~        -  How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks~        -  How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and~          other naturally occurring substances in your body~        -  How daily dosing of LY2393910 affects the cells that produce insulin~        -  Any differences in the above between LY2393910 taken as daily doses in the morning or~          in the evening~   "
137650|NCT01253265|"~     The purpose of this study is to evaluate the safety and tolerability of multiple doses of~     LY2439821 in Japanese patients with rheumatoid arthritis.~   "
137651|NCT01253252|"~     The purpose of this study is to determine whether Positron Emission Tomography imaging can~     help to predict the evolutivity of AAA treated with endovascular prosthesis.~   "
137652|NCT01253239|"~     The purpose of this study is to evaluate the visual performance of two cohorts of patients~     who received multifocal intraocular lenses following cataract and clear lens extraction~     surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal~     IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom~     Multifocal IOL in the opposite eye.~   "
137653|NCT01253226|"~     This study will evaluate the safety and tolerability of multiple doses of LY2127399 in~     Japanese patients with rheumatoid arthritis (RA).The study consists of a 20 week treatment~     period. All subjects will be followed up for 12 weeks after the last study drug~     administration.~   "
137654|NCT01253213|"~     The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2~     expression in human prostate by ultrasound molecular imaging.~      This will be compared with histopathology analysis (location based on expression of VEGFR2~     in tissue specimens determined by immuno-histochemistry, IHC).~   "
137655|NCT01253200|"~     The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the~     Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1~     atrial flutter. This study will compare outcomes in patients treated with the Blazer®~     Open-Irrigated Ablation Catheter to outcomes in patients treated with open-irrigated~     radiofrequency ablation catheters that have received FDA market approval for the treatment~     of type 1 atrial flutter.~   "
137656|NCT01253187|"~     The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive~     containing drospirenone and ethinylestradiol) with or without levomefolate calcium~     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the~     uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not~     using hormonal contraception~   "
137657|NCT01253174|"~     The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive~     containing drospirenone and ethinylestradiol) with or without levomefolate calcium~     (Metafolin, a registered vitamin supplement) in the body and to examine and compare the~     uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not~     using hormonal contraception.~   "
137658|NCT01253161|"~     The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can~     shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug~     will also be studied. The patient's physical state, changes in the size of the tumor, and~     laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and~     effective.~   "
137659|NCT01253148|"~     The purpose of this study is to see if Therasphere will be a better way to treat~     cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this~     treatment will have on the patient and their cancer.~   "
137660|NCT01253135|"~     The objective of this study is to evaluate the potential inhibitory effects of HP802-247~     Vehicle on wound closure (healing), by comparing mean days to closure of superficial~     (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.~   "
137661|NCT01253122|"~     A randomised four way crossover design in which each subject will receive two dose levels of~     TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised~     order.~   "
137662|NCT01253109|"~     This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED~     Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome~     and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish®~     output signal peak after induced fluctuation by physical exercise or pupil dilation.~   "
137663|NCT01253096|"~     Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and~     safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.~   "
137664|NCT01253083|"~     Background:~      - People who have cerebral palsy often have difficulty walking and moving their legs.~     Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which~     means that early motor skill development can be affected and can have repercussions for~     later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord~     injury) have shown that it is important to start intensive therapy soon after the injury,~     and it may be true that starting intensive therapy at a young age will be helpful for~     children with cerebral palsy. Researchers are interested in testing the effectiveness of a~     special body weight support system for mobility training in young children who have or are~     at risk for cerebral palsy.~      Objectives:~      - To study the effectiveness of a mobility training program on the motor skills of young~     children who have or are at risk for cerebral palsy.~      Eligibility:~      - Children between 12 and 36 months of age who have delayed motor skills and either have~     been diagnosed with cerebral palsy or show evidence of spasticity or brain damage.~      Design:~        -  This study involves two 6-week study phases: a baseline phase and a mobility training~          program.~        -  Participants will be screened with a physical examination and medical history.~        -  During the baseline phase, participants will have mobility testing sessions once every~          2 weeks. These tests will measure motor development and ability, including ease and~          speed of walking.~        -  Participants' parents/guardians will receive a mobility sensor for the child to wear at~          home for at least 6 hours (awake time) to measure activity and mobility levels outside~          of the testing sessions.~        -  After 6 weeks of baseline testing, participants will have 6 weeks of mobility training~          for 30 minutes 3 days per week. Training will involve motor tasks with weight support,~          conducted by a pediatric physical therapist. Activities may include walking, climbing~          inclines or steps, or squatting to reach toys. All sessions will be videotaped.~        -  To evaluate the effects of the therapy program, participants will have testing sessions~          every 2 weeks.~        -  Parents/guardians will also complete questionnaires to provide feedback on the~          effectiveness of the therapy program.~   "
137665|NCT01253070|"~     This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating~     older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective~     treatment for AML.~   "
137666|NCT01253057|"~     Several epidemiological studies found that exposure to antineoplastic agents were associated~     with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN),~     sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially~     exposed to these agents while cleaning ward, ward toilet or other area.~      One medical center and one area hospitals in Taipei.Surface wipe samples were collected in~     the cleaning staff work area, such as ward environment and ward toilet. Urine and blood~     samples of subjects were collected for exposure examinations. Platinum-containing drugs~     (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface~     wipe samples) and biological (urine and blood samples) samples.~      A self-administered questionnaire was used to collect demographic data, working practices,~     medical and contact history, and perceived work-related symptoms of cleaning staff.~      The results of this study will be to reduce exposure to cleaning staff.~   "
137667|NCT01253044|"~     This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present~     Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We~     hypothesize that ACT will be more effective than PCT at reducing emotional distress and~     improving functioning. We further hypothesize that both interventions will be highly~     acceptable to participants.~   "
137923|NCT01249677|"~     Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2~     diabetes. The investigators examined, whether chronic basal insulin treatment with insulin~     glargine lead to improvements in glucose-induced insulin secretion.~   "
137668|NCT01253031|"~     Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60~     years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing~     abilities provided by cognitive and memory processes are universally recognized as essential~     to adequate speech communication, but these processes are not well understood. Cognitive~     limitations in the ability to rapidly process sequential sounds occur with all listeners but~     may have more impact on older Veterans with and without hearing impairment. The purpose of~     this study is to examine and more thoroughly characterize the change in auditory working~     memory with hearing loss and increasing age. Young and older listeners with and without~     hearing loss will listen and report on two target sounds embedded in a stream of rapidly~     occurring sound. The investigators expect that older listeners without hearing loss will~     have more difficulty than young listeners but that older listeners with hearing impairment~     will have the most difficulty with this task even when the sounds they are listening to are~     adjusted to compensate for their hearing loss.~   "
137669|NCT01253018|"~     Robotic devices are capable of providing therapy to the arm of patients with weakness due to~     stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of~     the weak arm for real life situations often remains limited. The goal of this study is to~     determine the best way to use robotic devices and functional task training to improve the~     use of the stroke affected arm for real life situations. A secondary goal of this study is~     to determine how or if specific areas of the brain are excited before and after training.~     The use of a safe and painless magnetic field directed at the brain called transcranial~     magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of~     brain activity during recovery.~   "
137670|NCT01253005|"~     This study will investigate the effects of particle size of different triglyceride emulsions~     as well as the dynamics of intragastric structure formation and breakdown of the emulsions~     on GI function, the kinetics of the endocrine and the satiation response in healthy~     volunteers. 12 healthy participants will be studied on four occasions on four separate days~     in a double blind randomized design~   "
137671|NCT01252992|"~     Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of~     antituberculous treatment and leading to a worsening of tuberculous symptoms after an~     initial improvement. This phenomenon has very extensively studied in HIV infected patients~     where it corresponds to the so called IRIS (immune reconstitution syndrome). However, it~     laso occurs in non immuno-compromized patients, especially those with extra-pulmonary~     localization of tuberculosis. The aim of the study is to look for risk factors of~     paradoxical reaction in non immuno-compromized patients with extra-pulmonary tuberculosis.~     The investigators will consider clinical, radiological and biological variables, including~     specific immune and genetic markers. Our secondary goals are to estimate the incidence of~     PR, describe their natural history; characterize the type of immune response they correspond~     to, and look for better diagnostic tools.The immunological characterization and the finding~     of predictive factors of PR, especially the genetic ones will allow a better understanding~     of biological mechanisms that lead to their occurrence during extra-pulmonary tuberculosis~     treatment. The establishment of predictive criteria could permit a better surveillance of at~     risk patients for a rapid treatment, or even a prevention of PR. The establishment of new~     diagnostic criteria at the time of PR could avoid numerous invasive diagnostic procedures,~     surgery and/or useless prolongation of antibiotic treatment.~   "
137672|NCT01252979|"~     The current study is a prospective evaluation of the ability of ketosis to shift~     mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA~     at position 3243 (A>G). Subjects will be given supplemental medium chain triglycerides~     (MCTs) for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to~     treatment, at treatment initiation, and 6 months after initiation.~      The primary objective of the current study is to determine if there is a shift in~     heteroplasmy in patients harboring the 3243 A>G mtDNA mutation to a more favorable (higher~     wild-type) profile while in a state of ketosis.~   "
137673|NCT01252966|"~     This randomized clinical trial tested the effects of a computerized (web-based) cognitive~     training intervention on smoking cessation.~      All participants received 8 weeks of standard nicotine patch therapy, smoking cessation~     counseling, and were randomized to 1 of 2 different training programs: cognitive training~     vs. control training.~   "
137674|NCT01252953|"~     The Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)~     trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the~     risk of coronary death, myocardial infarction (MI) or coronary revascularization~     (collectively known as major coronary events) in patients with circulatory problems who have~     their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.~   "
137675|NCT01252940|"~     The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is~     to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil~     fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or~     fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor~     (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically~     suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment~     option to patients who wish to simplify dosing by reducing pill burden or to improve the~     tolerability of their treatment.~      Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which~     participants will switch treatment regimens at the start of the study, and the Stay on~     Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their~     baseline regimen during the first 24 weeks of the study (designed to provide an initial~     active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.~      After the 48-week study analysis period, participants may continue to receive the~     FTC/RPV/TDF STR per protocol before switching to a commercially available source.~   "
137696|NCT01252667|"~     This phase II trial studies the side effects and how well clofarabine works when given~     together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid~     leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving~     chemotherapy and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets.~   "
137676|NCT01252927|"~     The main objective of the proposed study is to evaluate the efficacy of a gatekeeper~     training suicide intervention program, Applied Suicide Intervention Skills Training (ASIST),~     in improving medical students' knowledge about suicide intervention, impact of attitudes on~     someone at risk for suicide and competent use of intervention skills to recognize risk and~     intervene effectively compared to medical education as usual. This research project will be~     undertaken using a randomized-controlled trial design. Questionnaires and objective~     structured clinical examinations using simulated patients will be completed at three time~     points: 1) before training, 2) after training, and 3) at one year following the training.~     Medical students' clinical skills in recognizing risk and intervening with simulated~     patients, as well as knowledge about suicide intervention and the impact of attitudes on~     someone at risk for suicide will be evaluated.~   "
137677|NCT01252914|"~     The purpose of this study is to assess the efficacy and safety of one iStent supra stent in~     the reduction of intraocular pressure associated with primary open-angle glaucoma.~   "
137678|NCT01252901|"~     The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an~     important role during urogenital development. Patients carrying a WT1 germline mutation show~     symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure. Milder~     variants are possible and classification is not always possible. In this registry we are~     collecting detailed clinical data of affected individuals to establish genotype-phenotype~     correlations with the greater goal to optimize patient care.~   "
137679|NCT01252888|"~     The purpose of this study is to assess efficacy and safety of two iStents for the reduction~     of intraocular pressure associated with primary open-angle glaucoma.~   "
137680|NCT01252875|"~     The aim of this study is the evaluation of two usual care strategies after stroke or TIA :~     achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will~     use the statin and titrate the dosage to achieve the target assigned by randomization in~     monotherapy or in combination with ezetimibe or other drugs.~      The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and~     vascular death in each group.~      3760 patients will be recruited and followed for eight and a half years maximum.~   "
137681|NCT01252862|"~     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of~     two iStent devices in eyes of subjects with primary open-angle glaucoma~   "
137682|NCT01252849|"~     The purpose of this study is to evaluate the safety and efficacy of the iStent medical~     device that is implanted into the eye and designed to reduce eye pressure in patients with~     your condition.~   "
137683|NCT01252836|"~     Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.~   "
137684|NCT01252823|"~     The purpose of this study is to use implantable loop recorder (ILR) in patients under~     chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with~     hemodialysis parameters.~   "
137685|NCT01252810|"~     To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when~     compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either~     chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive~     heart failure (CHF) NYHA Class III or greater, who are referred for a coronary~     catheterization procedure with or without PCI.~   "
137686|NCT01252797|"~     This study will investigate the safety, tolerability, and effectiveness of changing the~     order of receiving radiation therapy for treating brain cancer. The investigators hope that~     changing the sequence of radiation therapy will lower the risk of cancer spreading~     throughout your spinal fluid, which covers your brain and spinal cord.~   "
137687|NCT01252784|"~     The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity~     conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with~     higher risk MDS.~   "
137688|NCT01252771|"~     The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM)~     in the hemodialysis patient population. This computerized algorithm model was developed as a~     tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a~     subject consents to participate in the study, the subject's dietary phosphate intake will be~     estimated by the modeling program and the appropriate dose of the phosphate binder calcium~     acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of~     the dialysate will be changed to remove any excess calcium absorbed as the result of an~     increase in the PhosLo prescription to control phosphorus.~   "
137689|NCT01252758|"~     The drug product albuterol sulfate DPI, TBS-7, is a single dose inhalation product of~     albuterol sulfate containing 240 ug albuterol sulphate (200 ug of albuterol) and inhalation~     grade lactose in a new dry powder delivery system called the Trivair deposition system.~      Three different doses of albuterol sulfate DPI, TBS-7, will be administered in this dose~     ranging clinical trial: an optimal dose, 80% of the optimal dose and 50% of the optimal dose~     and will be compared with placebo and an active comparator.~   "
137690|NCT01252745|"~     This clinical trial will compare the pharmacokinetic profile of testosterone after repeated~     intranasal administration of TBS-1 of different strengths in subjects with hypogonadism~   "
137691|NCT01252732|"~     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of~     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential~     economic benefit of oritavancin administered as a single 1200 mg IV dose.~   "
137692|NCT01252719|"~     The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of~     oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential~     economic benefit of oritavancin administered as a single 1200 mg IV dose.~   "
137693|NCT01252706|"~     The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine~     among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov)~     and to evaluate study Brief Intervention impact on reduction exposure, and its effect on~     newborn outcomes.~   "
137694|NCT01252693|"~     The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix~     administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men~     with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days~     study. Men who are at least 18 years of age or older, with histologically proven prostate~     cancer of all stages, in whom endocrine treatment is indicated will be eligible for study~     entry.~   "
137697|NCT01252654|"~     Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery~     for refractive error). Their use has decreased the incidence of serious complications when~     compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser~     currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available~     and differs from the Intralase in that it does not interfere with the curvature of the~     cornea when creating the flap. The Intralase applanates the cornea flat during flap creation~     which causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are~     available to patients and surgeons to use at SNEC. The aim of the investigators study is to~     compare the two lasers in a randomization of left and right eyes in the same patient. The~     investigators want to measure any difference that the lower intraocular pressure may have~     during the creation of the flap. This will be measured with a questionaire on patient~     experience during the procedure and the outcomes of vision, refraction, contrast~     sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness~     measured with anterior segment OCT during the post-operative follow up period. To date~     no-one has compared the use of these two femtosecond lasers. Both lasers are currently used~     clinically for flap creation at SNEC.~   "
137698|NCT01252641|"~     This research study is being carried out to study a new way to possibly treat human~     immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained~     from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases.~     The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells~     are one of the white blood cells used by the body to fight HIV. The most important of these~     are called CD4+ T-cells~      Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and~     are resistant to infection with HIV. Other people have a low number of CCR5 genes on their~     T-cells and their HIV disease is less severe and is slower to cause disease (AIDS).~      The purpose of this research study is to find out whether SB-728-T is safe to give to humans~     and find out how this affects HIV.~   "
137699|NCT01252628|"~     The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a~     cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of~     PX-866 to be given in combination with cetuximab will be determined in patients with~     incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase~     2 part of the study is a randomized evaluation of the antitumor activity and safety of~     PX-866 in combination with cetuximab versus cetuximab alone in patients with either~     incurable metastatic CRC who have a history of progression or recurrence following prior~     irinotecan and oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or~     incurable progressive, recurrent or metastatic SCCHN (Group 2).~   "
137700|NCT01252615|"~     The goal of this study is to compare a patient only to a patient+partner intervention on~     recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator~     (ICD) implantation.~   "
137701|NCT01252602|"~     The purpose of this prospective cohort study is to search for a relationship between~     maternal depression in the third trimester, as indicated by a score of > 12 on the EPDS, and~     a choice not to breastfeed at all, defined as no breastfeeding after dismissal from the~     hospital. The investigators hypothesize that women who screen positive for prenatal~     depression will be significantly less likely to breastfeed their babies after discharge from~     the hospital following childbirth.~   "
137702|NCT01252589|"~     Although the impact of disease and treatment related burden on health-related quality of~     life (HRQOL) in patients with solid tumours has been well studied, with several clinical~     trials that included HRQOL as an endpoint, the general understanding in patients with~     Chronic Myeloid Leukaemia (CML) is lacking in comparison.~      The literature shows that patients' perspective is unique and should always be measured with~     methodologically sound instruments that are devised for this purpose.~      The main scope of this project is develop to an international validated questionnaire for~     the purpose of HRQOL assessment; such a tool will then be used to provide important data,~     from the patients' perspective, to make more informed treatment decisions.~   "
137703|NCT01252576|"~     300 italian women will be enroll for linguistic and cultural validation in italian of Female~     sexual function index (FSFI). This questionnaire is used in most countries to investigate~     female sexual function. To date there are not validate questionnaires in italian on female~     sexual function. We decided to start the validation process to give a validated tool to~     italian investigators.~   "
137704|NCT01252563|"~     In this survey, to collect the safety and efficacy information in the subjects who have been~     treated with amlodipine 5mg at least 4 weeks in daily practice.~   "
137705|NCT01252550|"~     The purpose of this study is to investigate the association between gut microbiota,~     immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to~     assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge~     test in IBS patients.~   "
137718|NCT01252381|"~     The aim is to investigate the importance of vitamin D levels to achieve the effect of~     strength training. If we can show that vitamin D has an effect of training, the ultimate~     goal is to find out why and how vitamin D affects muscle.~      This would potentially have important implications for public health. Since a large number~     of populations, including elderly, are shown to have too little vitamin D and also has low~     muscle strength, it will be essential that these people added vitamin D in relation to~     training and rehabilitation.~   "
137728|NCT01252251|"~     The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus~     and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230.~     Pasireotide is an experimental drug and is not approved by the Food and Drug Administration.~     Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney~     cancer. Everolimus is not approved for treatment of melanomas, but early studies show that~     it may help some patients with melanoma.~   "
137762|NCT01251809|"~     This is an assessment of efficacy and safety of three different doses of pegylated~     recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults~     with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for~     determining specific asparaginase doses to yield various durations of L-asparagine (ASN)~     depletion which are required within different treatment phases of ALL therapy.~   "
137706|NCT01252537|"~     Background: Tuberculosis (TB) and HIV are leading causes of disease and death in Subsaharan~     Africa. Antiretroviral therapy (ART) dramatically improves prognosis in HIV infection, but~     TB is still a common complication in HIV-infected subjects. Management of TB-HIV~     co-infection is complex, both with regard to diagnosis and treatment. Since scaling-up of~     ART requires management of most patients in primary health care, it is critical to achieve~     better strategies for TB-HIV co-infection at peripheral levels of the health care system in~     endemic regions. This includes development of new methods to assess the severity of HIV~     disease and the need to start ART during TB treatment in this population.~      Aims: To compare a scoring system for clinical signs of immunosuppression with CD4 cell~     counts to assess HIV disease severity and indications for ART initiation, and to correlate~     immunosuppression status with treatment outcome.~      Workplan: CD4 cell levels and results of clinical scoring has been compared in 1100 patients~     with TB, using HIV-negative subjects with TB treatment for control. Inclusion was closed in~     February 2012, and follow-up of participants completed in August 2012. Plasma levels of~     immune activation and inflammatory markers will be correlated with the degree of~     immunosuppression.~      Significance: TB is the most significant clinical challenge to the successful scaling-up of~     ART in Africa. In order to improve management in primary health care it is necessary to find~     robust and reliable techniques for determining disease severity and identification of~     patients who need to start ART during TB treatment. This study may contribute to increased~     knowledge in this field and help to modify guidelines for management of TB-HIV co-infection~     in Ethiopia as well as in other resource-limited settings.~   "
137707|NCT01252524|"~     The purpose of this study is to determine whether a form of fiber if effective in improving~     the treatment of type 2 diabetes. Measurements of other possible medical benefits will~     include blood pressure, cholesterol, weight, and the number/dosage of medications used for~     diabetes, hypertension, and high cholesterol.~   "
137708|NCT01252511|"~     The purpose of this study is to determine whether or not the length of the biliopancreatic~     limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption~     after gastric bypass for treatment of severe obesity.~   "
137709|NCT01252498|"~     This study will evaluate the role of cyclooxygenase pathways in radiation-induced and~     chemoradiation-induced mucositis.~   "
137710|NCT01252485|"~     This is a registry study in adult patients with newly diagnosed or refractory/relapsed~     myeloid neoplasms~      Investigator's sites: 60-70 sites in Germany and Austria~      Estimated duration of observation of an individual patient:~      10 years maximum~      Objectives~        -  To register all patients with acute myeloid leukemia and related precursor neoplasms,~          acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS~          with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly~          diagnosed or relapsed/refractory in all participating centers (completeness)~        -  To perform timely analyses of disease-related genetic markers (incidences, treatment~          recommendations)~        -  To assess patient and family history, clinical characteristics and outcome data~          (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence~          of death [CID], overall survival [OS])~        -  To assess biological disease features and correlate with clinical outcome data~          (prognostic and predictive markers)~        -  To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue,~          e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum)~        -  To assess quality of life~   "
137711|NCT01252472|"~     Some men who have a history of use of Tamsulosin (Flomax) are at risk for a condition called~     Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract~     surgery. It is not fully understood why this condition develops or who is at risk for~     developing it. In this study the investigators will take pictures of the iris and iris blood~     vessels before cataract surgery. The investigators hope that the results of this study will~     provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give~     us a non-surgical way of figuring out who might develop this problem during surgery.~   "
137712|NCT01252459|"~     This study is designed to evaluate the impact of radiotherapy target volume delineation~     based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted~     MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well~     as concerning therapeutic safety of the respective strategy.~   "
137713|NCT01252446|"~     This article reviews social-demographic variables (SDV) including interpersonal and academic~     and social performance in families and comorbid conditions(CC) which are the most associated~     with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed~     diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.~      There are no reports of this kind in the Norwegian population with ADHD.~   "
137714|NCT01252433|"~     The purpose of this research is to investigate children's responses to incorporating~     vegetables into selected entrees and snacks over several days. The hypothesis is that~     children will increase their vegetable intake by consuming foods that have been reduced in~     energy density through the addition of vegetables. Effects on energy intake will also be~     examined.~   "
137715|NCT01252420|"~     The purpose of this study is to determine whether a limited duration of treatment (two weeks~     of low molecular weight treatment) is a safe and effective treatment for distal deep vein~     thrombosis of the lower limb.~   "
137716|NCT01252407|"~     The purpose of this study is to determine acute effect the transctutaneous electrical nerve~     stimulation in sympathetic and parassympathetic system in individuals with heart failure.~   "
137717|NCT01252394|"~     The study aims to investigate the correspondence between changes in central venous oxygen~     saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients~     with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac~     output measurements during ongoing hemodialysis. Provided this validation is satisfactory,~     impedance cardiography cardiac output and ScO2 will be measured at intervals during~     hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and~     trends will be compared.~   "
137752|NCT01251939|"~     Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm~     infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the~     renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and~     may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.~   "
137719|NCT01252368|"~     Aim of this trial is to investigate the expression and localisation of different amino acid~     transporters and their regulatory proteins derived from the regulatory proteins of the local~     renin angiotensin system (RAS) in the intestine. This is investigated on one hand in~     patients who do not take any drugs interfering with RAS. On the other hand expression~     analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.~      After obtaining informed consent of patients attending the hospital for clarification of~     gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to~     biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum~     and descending colon.~      Biopsies are investigated anonymously at the Institute of Physiology of the University of~     Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively,~     in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed~     with immunohistochemistry.~      Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From~     plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7)~     are measured.~   "
137720|NCT01252355|"~     The primary objective was to demonstrate the effect of teriflunomide, in comparison to~     placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms~     of MS who are treated with Interferon-beta (IFN-beta).~      The secondary objectives were:~        -  Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta~          on:~             -  Disease activity as measured by brain Magnetic Resonance Imaging (MRI)~             -  Disability progression~             -  Burden of disease and disease progression as measured by brain MRI~        -  Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy~        -  Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta~          therapy~        -  Assess associations between variations in genes and clinical outcomes (safety and~          efficacy)~        -  Assess other measures of efficacy of teriflunomide such as fatigue and health-related~          quality of life~        -  Assess measures of health economics (hospitalization due to relapse, including the~          length of stay and any admission to intensive care unit)~   "
137721|NCT01252342|"~     Oxytocin use has become routine practice in elective cesarean delivery to promote uterine~     contraction and reduce blood loss. However, there is a lack of consensus regarding the best~     dose of oxytocin and the most effective route of administration. Most dosage and delivery~     systems have been empirically derived.~      It is currently our practice at the Royal University Hospital to start an oxytocin infusion~     (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous~     oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also~     choose to inject bolus oxytocin directly into the uterus (intramyometrial).~      The primary objectives of the study include:~        1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to~          prevent need for additional uterotonics, including additional oxytocin;~        2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the~          primary outcome (uterine tone) and secondary outcomes (estimated blood loss,~          preoperative to postoperative change in hematocrit, need for additional uterotonics,~          and need for blood pressure support); and~        3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to~          augment uterine contraction.~      The working hypothesis is that the use of intramyometrial oxytocin will not improve primary~     or secondary outcomes compared to the current practice of an oxytocin infusion alone.~   "
137722|NCT01252329|"~     This study will evaluate if there is a difference in survival between elective treatment of~     draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for~     high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node~     exam. Each treatment arm is accepted as a current standard of care, and the objective is to~     compare outcomes between the two arms.~   "
137723|NCT01252316|"~     Each year in the United States, 300,000 people suffer from Cardiac Arrest (CA), and of them~     there is a 90% mortality rate. Out-of-Hospital arrests in particular have a 1-5% survival to~     hospital discharge. High quality CPR is crucial to lowering the mortality rate and~     increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR.~     Studies have shown that prompt administration of CPR dramatically improves outcomes. In a~     recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our~     study will look to train family members of at-risk cardiac patients in the skills of CPR~     through the American Heart Associations (AHA) CPR Anytime Friends and Family Personal~     Learning Program (CPR Anytime) to see if these family members are able to learn and perform~     quality CPR in the event that their family member should suffer a cardiac arrest. The unique~     feature of the CPR Anytime training is that it is a low-cost, self-learning, video-based~     program that can be completed in under 30 minutes, saving the time and expense of~     traditional CPR training courses. While initial work has proven that teaching CPR in~     hospital using the VSI kit is feasible, little research has been conducted to make the~     program sustainable.~   "
137724|NCT01252303|"~     The study is to determine the effect of a behavioral weight loss program supplemented with~     Nutrisystem meal replacements on weight, blood pressure, fasting blood glucose, and blood~     lipids levels over 12 weeks.~   "
137725|NCT01252290|"~     This study is designed to gather information on how the prescription drug Lovaza™ which~     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.~     This drug is currently approved by the FDA for reducing blood levels of triglycerides.~   "
137726|NCT01252277|"~     This study is designed to gather information on how the prescription drug Lovaza™ which~     contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.~     This drug is currently approved by the FDA for reducing blood levels of triglycerides.~   "
137727|NCT01252264|"~     The purpose of this study is to find out if there are any genetic differences between people~     with and without disorders of the head, face, and eye. We will create a biorepository of~     samples from people with and without these types of birth defects. A biorepository is a~     collection or bank of human tissue materials (such as blood or saliva) for research~     purposes. These samples will then be available to investigators studying these disorders.~   "
137791|NCT01251419|"~     The goal of this project is to understand the effects of receiving peer information on~     individuals' conversion rates from brand name prescription medication to generic~     prescription medication.~   "
137729|NCT01252238|"~     This study is an investigation of the effect of commonly prescribed anti-hypertensive agents~     on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are~     as follows:~      Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition~     for 12 weeks modifies glucose homeostasis and insulin sensitivity.~      To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a~     three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as~     assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed~     basally and after twelve weeks of treatment with either a calcium channel blocker with~     placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker~     with a renin inhibitor and an angiotensin receptor antagonist.~      Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition~     for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium~     intake.~      The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial~     relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance~     (characteristic aortic impedance) will be measured at baseline and then after acute and~     chronic renin inhibition:~        1. Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both~          high and low dietary sodium intake conditions (~1 week each) before and after a single~          dose of a renin inhibitor.~        2. Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at~          baseline and after 12 weeks of each of the three drug treatment arms above.~      The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.~   "
137730|NCT01252225|"~     People cough in order to clear their airways. Most coughs are caused by viruses and settle~     down by themselves, but some people develop persistent coughing which can be anywhere from 8~     weeks to several years. This is called chronic cough. People with chronic cough find the~     symptom distressing and it can have a major impact on their quality of life. Patients with~     chronic cough often report a sensation at the back of their throat which makes them feel an~     urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical~     procedures) can suppress a person's cough when given to patients via a nebuliser (a machine~     that turns liquid into a fine mist).~      It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of~     a throat spray would successfully suppress a person's cough. A throat spray would be an~     easier treatment option in chronic cough patients. Thus, the investigators research aims to~     compare cough rates, severity and urge to cough scores between Lidocaine throat spray and~     nebulised Lidocaine.~   "
137731|NCT01252212|"~     In this project, we will work directly with underserved patients in a safety-net setting to~     conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel~     adherence intervention embedded in an existing PHR that uses cellular phone short message~     service (SMS) reminders and patient responses to the reminders. We will compare adherence~     rates in both arms as assessed by antiretroviral medication concentrations in hair samples~     and self-report; clinical outcomes will also be compared in the two arms. The project will~     examine medication adherence for antiretroviral medications and treatments of common~     conditions such as depression, hypertension, diabetes and hypercholesterolemia.~   "
137732|NCT01252199|"~     This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered~     concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB)~     Infection.~   "
137733|NCT01252186|"~     This study is being conducted to evaluate the impact of a 91-day extended cycle oral~     contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in~     healthy women.~   "
137734|NCT01252173|"~     The purpose of this research is to measure the endotracheal tube cuff pressure in patients~     who have been endotracheally intubated emergently in the emergency department or in the~     field by prehospital personnel. Overinflation of ETTc pressure is associated with injury,~     and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in~     endotracheally intubated patients in the ED.~      There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc~     pressure is already performed by respiratory therapy/respiratory care. We simply seek to~     assess these measurements to determine if any patients in fact have high ETTc pressure. If~     it is found that patients do have ETTc with high pressures, this might allow emergency~     department staff or prehospital personnel such as paramedics or EMTs to use this information~     to seek methods by which endotracheal intubation can be improved and patients can be~     intubated without excessive ETTc pressure.~      This is a pilot study. We have conducted several in vitro studies, which have all~     demonstrated that paramedics, EMTs, and emergency department physicians practice~     endotracheal intubation in a method that might result in excessively inflated ETTc.~   "
137735|NCT01252160|"~     In this study all patients will be treated with the same medicine, the QUTENZA patch.~     Subjects will receive up to 6 QUTENZA patch applications over 12 months.~   "
137736|NCT01252147|"~     This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash~     Assessment (GEA) scale with photonumeric guide in Japanese subjects.~   "
137737|NCT01252134|"~     The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone~     hydrogel (SiH) contact lens with three marketed contact lens care solutions.~   "
137738|NCT01252121|"~     The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared~     to Hialid and saline.~   "
137761|NCT01251822|"~     This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that~     of prucalopride in the treatment of chronic constipation in females. A total of 240 patients~     will be randomly allocated to treatment with one or the other agent. The study consists of a~     14-day run-in period, with treatment subsequently administered for 28 days on a daily basis.~     During the study, patients will fill in a stool diary, samples of faeces will be collected,~     and colonic transit time will be measured prior to therapy, and from days 22 to 28 of~     treatment. The proportion of patients with normalised bowel movements (three or more~     spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will~     be compared between treatments.~   "
137792|NCT01251406|"~     The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1~     (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged~     heart muscle cells to restore their structure and function. This study will investigate the~     safety and efficacy of rhNRG-1 to treat stable chronic heart failure.~   "
137739|NCT01252108|"~     Helicobacter pylori infection of the gastric epithelium is the most common bacterial~     infection worldwide. Its global prevalence is estimated at 50%, though the burden falls~     disproportionately on the developing world, where the prevalence in some areas is 80%. H.~     pylori infection is generally acquired during childhood, and without specific antibiotic~     treatment can persist for life. The infection is generally clinically asymptomatic during~     childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic~     (although they may transmit the bacteria).~      SQ109 is a new, small molecule antibiotic with characteristics that make it particularly~     attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable,~     acid-stable, has in vitro activity against H. pylori and achieves high intracellular~     concentration (which may be important to effect bacterial eradication).~      Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this~     clinical trial to assess safety and antimicrobial activity in adults infected with H.~     pylori. Data from this study will help determine whether larger safety and efficacy studies~     in individuals with H. pylori-associated duodenal ulcer disease are warranted.~   "
137740|NCT01252095|"~     This first-in-human study aims to establish the maximum tolerated dose of PG545 and to~     evaluate its safety in subjects with advanced solid tumours. In addition the study will~     explore whether PG545 exposure results in changes to chemicals produced by the body that are~     associated with cancer growth and spread.~   "
137741|NCT01252082|"~     The purpose of this study is to determine whether nonsurgical periodontal therapy is~     effective in the metabolic control of patients with type II Diabetes mellitus.~   "
137742|NCT01252069|"~     This is the long-term extension of a phase III, efficacy and safety open-label (protocol~     PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the~     administration of progestin or placebo tablets after end of PGL4001 treatment.~      This extension study consists of three periods of 3 months open-label PGL4001 treatment,~     each followed by ten days of double-blind treatment with progestin or placebo and then a~     period without treatment.~   "
137743|NCT01252056|"~     The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic~     nephropathy is better than the single use.~   "
137744|NCT01252043|"~     The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA~     survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and~     the measurement of transverse diameters of paraesophageal and gastroesophageal veins.~   "
137745|NCT01252030|"~     In this study, 80 coronary artery disease patients with successful coronary~     revascularisation (by CABG or PCI) will be included. Patients are excluded in case of:~     congestive heart failure, ICD or pacemaker, any disability limiting exercise participation.~      These patients are attending phase 2-3 cardiac rehabilitation, and have completed 6 weeks of~     rehabilitation. Next, subjects are randomly assigned to a control group or an intervention~     group.~      Outcome parameters: physical activity, exercise capacity, blood glucose, insulin level and~     lipid profile, body weight and waist circumference, cardiovascular morbidity and mortality.~      Hypothesis: telemonitoring of physical activity will increase physical activity, and improve~     cardiovascular disease risk factors, in CAD patients attending phase 2-3 cardiac~     rehabilitation.~   "
137746|NCT01252017|"~     The purpose of this study is to determine whether nilotinib is effective in the prophylaxis~     and treatment of CMV reactivation in allo-HSCT patients.~   "
137747|NCT01252004|"~     Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or~     physical stress, a clinical and ECG of acute myocardial infarction without significant~     coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who~     takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap~     called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate~     life-threatening prognosis is often good in the longer term.~   "
137748|NCT01251991|"~     Despite improved treatment, cardiovascular disease remains one of the most common diseases~     and causes of death in the Western world. Hypercholesterolemia is a well known risk factor~     for developing cardiovascular disease. Prevention and treatment are based in part on~     lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the~     treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL~     cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements~     have been demonstrated in numerous studies. Cholesterol lowering food supplements include~     isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated~     mechanisms of action responsible for the cholesterol lowering in these two food supplements~     are different, so there is a reason to expect an additive cholesterol lowering effect during~     concomitant treatment with both substances. The investigators want to investigate whether~     concomitant treatment with psyllium husks and isolated soy protein in addition to a~     heart-healthy diet results in a significantly greater reduction of LDL cholesterol in~     hypercholesterolemia, than single treatment with each of the substances.~   "
137749|NCT01251978|"~     Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients~     with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can~     help reduce the number of laser treatments that might be needed to control the tumor.~   "
137750|NCT01251965|"~     The goal of this clinical research study is to find the highest tolerable dose of~     ruxolitinib that can be given to patients with acute leukemia and to learn if the study drug~     can help control the disease. The safety of the drug will also be studied.~   "
137751|NCT01251952|"~     The primary goal of this study is to determine the feasibility and safety of giving two~     doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation~     in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the~     number and percentage of T-regs in the peripheral blood post transplant at each dose level,~     the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and~     determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3~     consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).~      The hypothesis for the study is based on the ability of DD to deplete T-regs and~     subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This~     may indirectly enhance the efficacy of autologous transplantation and reduce disease~     relapse.~   "
137753|NCT01251926|"~     Background:~      - The anticancer drug bevacizumab works by reducing the formation of new blood vessels in~     tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The~     experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar~     to EZN-2208 also work by turning off the production of the HIF protein, which otherwise can~     help cancer cells to grow even when blood supply is limited. Researchers are interested in~     determining if EZN-2208 turns off HIF in patient tumors, and whether combining it with~     bevacizumab is an effective treatment for cancers that have not responded to standard~     treatment.~      Objectives:~      - To assess the safety and effectiveness of the combination of EZN-2208 and bevacizumab for~     solid tumors that have not responded to standard treatment.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors that have not responded to~     standard treatment.~      Design:~        -  Participants will be screened with a full physical examination and medical history,~          blood and urine samples, and tumor imaging studies.~        -  Participants will receive EZN-2208 and bevacizumab intravenously on an outpatient basis~          in 4-week cycles (with the exception of the first cycle, which will be 5 weeks).~        -  Cycle 1: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1,~          8, and 15), followed by 1 week without the drug. Participants will receive bevacizumab~          1 week before EZN-2208 (day - 7) and then 3 weeks later (day 15).~        -  Subsequent cycles: Participants will receive EZN-2208 once a week for 3 weeks in a row~          (days 1, 8, and 15), followed by 1 week without the drug. Participants will receive~          bevacizumab every 2 weeks (days 1 and 15).~        -  Participants will have clinic visits with physical examinations and blood tests in the~          first 3 weeks of each cycle. Clinic visits may also include tumor imaging studies and~          tumor biopsies as directed by the study researchers.~        -  Participants will continue to take the study drugs for as long as the tumor shrinks or~          does not grow, and as long as they do not experience intolerable or unsafe side effects~          from the drugs....~   "
137754|NCT01251913|"~     Background:~      - An important new area of brain tumor research is the development of tumor and brain stem~     cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh~     tumor and brain tissue, which is best accomplished by harvesting whole brains from recently~     deceased patients. These cell lines will help researchers understand how these tumors~     develop and will also help identify new targets for treatment. Researchers are interested in~     conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue~     harvest at the time of death.~      Objectives:~        -  To provide high-quality end of life inpatient hospice care for patients with~          untreatable brain tumors.~        -  To procure brain and tumor tissue shortly after time of death in order to derive viable~          tumor and neural stem cell lines for research purposes.~      Eligibility:~        -  Individuals at least 18 years of age who have an untreatable primary brain or central~          nervous system tumor, are able to give informed consent (either their own or through a~          designated power of attorney), and have agreed to a Do Not Resuscitate order and~          Consent for Autopsy as part of the end-of-life care plan.~        -  HIV-positive individuals or those suspected of having infectious cerebritis are not~          eligible because of the potential for contamination of brain tissue.~      Design:~        -  Participants will be enrolled in inpatient hospice admission to the National Institutes~          of Health Clinical Center either from home or from an outside hospital once a study~          investigator estimates an expected survival of less than 2 weeks.~        -  Participants will receive palliative care at the Clinical Center. Care will be tailored~          to each participant depending on the information provided in the individual's~          end-of-life care plan.~        -  Supportive medications such as antiseizure medications and pain relievers will be~          administered as appropriate.~        -  At the time of death, researchers will follow standard procedures for notifying next of~          kin and will collect brain tissue and tumor samples from the deceased.~        -  Following tissue collection, the deceased will be released for autopsy and funeral~          procedures.~   "
137755|NCT01251900|"~     Background:~      - BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast~     cancer and other cancers, and may be associated with types of breast cancer that are more~     difficult to treat and more likely to recur. New cancer treatments are being developed~     specifically to treat individuals who have these gene mutations. However, more information~     is needed about the prevalence of these mutations in minority populations, including~     Hispanic/Latino populations. To study these populations, researchers are interested in~     collecting genetic material (DNA) and medical history information from Hispanic/Latino women~     who have been diagnosed with breast cancer.~      Objectives:~      - To collect saliva samples and medical and family history information from Hispanic/Latino~     women with breast cancer.~      Eligibility:~      - Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.~      Design:~        -  Participants will complete a questionnaire with information about place of birth,~          languages spoken by parents and grandparents, and information about their breast cancer~          diagnosis.~        -  Participants will provide a saliva sample (2 to 3 tablespoons) for analysis.~        -  No treatment will be provided as part of this protocol.~   "
137756|NCT01251887|"~     Background:~      - Rates of obesity have increased dramatically in recent decades, and researchers are~     investigating how changes in diets and physical activity have contributed to this increase.~     To understand how weight might be controlled, it is important to learn what kinds of dietary~     changes can affect hunger and might lower body weight. Essential fatty acids, for instance,~     are an important part of a healthy diet, but researchers have not yet determined the ideal~     amount of essential fatty acids that people should eat. By studying how different diets~     affect body chemistry and hormone levels in women who are overweight or obese, researchers~     hope to be able to determine better diets or treatments to help people reach and maintain an~     optimum healthy weight.~      Objectives:~      - To examine how certain fats in the diet affect body metabolism, hormones, and weight~     regulation.~      Eligibility:~      - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index~     between 25 and 35).~      Design:~        -  This study has an initial screening visit and three phases. All participants will be~          involved in the first two phases of the study, and some participants will be involved~          in the third phase.~        -  Participants will be screened with a physical examination and medical history, in~          addition to blood and urine tests and questionnaires about eating habits and other diet~          factors.~        -  Phase 1: Participants will have three visits to the National Institutes of Health over~          a 4-week period. At the visits, participants will have blood and urine tests, complete~          questionnaires, and have other tests including brain and body imaging studies.~          Participants will then be assigned to one of three study diets.~        -  Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the~          study researchers. Participants will keep a daily log of food and beverage intake, and~          will have three testing sessions with procedures similar to those performed in Phase 1.~        -  Phase 3: Participants assigned to a particular study diet (one-third of all~          participants) will be given the option of continuing the diet for an additional 36~          weeks (9 months), with food consumption, monitoring, and testing procedures similar to~          those performed in Phase 2....~   "
137757|NCT01251874|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with carboplatin and to see how well they work in treating patients with human epidermal~     growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body.~     Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the~     cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA.~     Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able~     to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than~     carboplatin alone.~   "
137758|NCT01251861|"~     This phase II trial studies how well giving bicalutamide with or without Akt inhibitor~     MK2206 works in treating patients with previously treated prostate cancer. Androgens can~     cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may~     lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating~     prostate cancer.~   "
137759|NCT01251848|"~     The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each~     other when coadministered.~   "
137760|NCT01251835|"~     This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of~     sitaxsentan given alone and with rifampin will also be assessed.~   "
137937|NCT01249495|"~     The purpose of this study is to investigate the rate of wound healing using sharp~     debridement using curette and to compare between such intensive treatment at hospital and~     treatment in primary care. A correlation between change in wound size and pro-inflammatory~     cytokines will also be made.~   "
137763|NCT01251796|"~     This is a phase I study to determine the safety, tolerability and recommended phase II dose~     of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor~     metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic~     profile and antitumor activity of ARQ 197 administered alone or in combination with~     erlotinib will also be determined as secondary endpoints.~   "
137764|NCT01251783|"~     Objectives: To evaluate the safety; efficacy; bone mineral metabolism & immunity changes of~     the use of Metlin & Metlos added to the Infant Formula Study Design: Randomized, double~     blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to~     recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula~     with probiotics + Metlos; formula only with probiotics or formula without probiotics and~     prebiotics; having a totally breast feed group as control.). Outcomes variables were~     frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency,~     regurgitations, vomiting); report of dermatological problems like eczema; changes on the~     intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated~     to cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean~     circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and~     changes in the immunity (changes in the concentrations of salivary IgA and the frequency of~     respiratory events suggestive of infection)]. Statistical analysis was made with STATA Ver.~     11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of~     categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When~     convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for~     continuous numerical outcomes or logistic regression for categoric outcomes. In all the~     hypothesis tests the p significant value of <0.05 were used.~   "
137765|NCT01251770|"~     The primary objective of this study is to compare the blood sodium level after 12 hours~     following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose~     5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.~   "
137766|NCT01251757|"~     The purpose of this randomized clinical trial is to determine whether two low-intensity,~     technology based interventions, when compared to each other and to usual care, improve~     adherence to selected medications that are used to treat people with cardiovascular disease~     (CVD) and diabetes.~   "
137767|NCT01251744|"~     This study is designed to evaluate maternal virological and immunological parameters to~     determine their ability to predict congenital cytomegalovirus (CMV) infection. When a~     pregnant woman is infected with CMV, her immune system (which protects her from infection)~     is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine,~     vaginal secretions). The aim of this study is to find out if there is a link between either~     the pregnant woman's immune response or the presence of the virus in these bodily fluids and~     the child/foetus being infected with the virus.~   "
137768|NCT01251731|"~     The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK),~     pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a~     selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.~   "
137769|NCT01251718|"~     To investigate the clinical safety and effectiveness of donepezil hydrochloride~     administration in patients with mild or moderate Alzheimer's Disease~   "
137770|NCT01251705|"~     Comparison of different methods for measuring peoples corneal thickness~   "
137771|NCT01251692|"~     To determine the ten-year visual results and outcome of excimer laser phototherapeutic~     keratectomy (PTK) for recurrent corneal erosions.~   "
137772|NCT01251679|"~     The purpose of this study is to determine whether nonpharmaceutical interventions (i.e.,~     handwashing and masks) reduce secondary transmission of influenza in households.~   "
137773|NCT01251666|"~     Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health~     priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while~     the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless~     automated quantitative I-FOBTs have not been compared, and the optimal number of samples and~     threshold is not yet fixed. The aim of this study is to compare the performances of the 2~     more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by~     Eiken) for different positivity thresholds and numbers of samples in general average risk~     population. Patients will performed a two samples Magstream, a two samples OC Sensor and~     Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and~     specificity for detection of cancer and advanced neoplasias will be compared between tests~     using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of~     samples and positivity threshold.~   "
137774|NCT01251653|"~     To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in~     combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.~      To assess the safety of the combination. To investigate the PK characteristics of docetaxel~     or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess~     antitumor activity.~   "
137775|NCT01251640|"~     Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766~     plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.~      Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine~     (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.~      Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:~     response duration, disease control rate, time to progression, progression-free survival,~     overall survival, safety and tolerability.~      Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and~     weekly throughout the study; Safety follow-up visit 30 days after the last dose of study~     treatment; Survival follow up monthly for up to 8 month after LPFV.~   "
137776|NCT01251627|"~     The study aims to assess the activity of decitabine in the treatment of CMML.~   "
137777|NCT01251614|"~     This study will compare how well adalimumab works versus methotrexate (MTX) in children with~     moderate to severe psoriasis in the short term. It will also study how safe and how well~     adalimumab works in the long term and how long disease response can be maintained after~     stopping therapy.~   "
137778|NCT01251601|"~     The purpose of this study is to determine whether pregnancy affects the blood concentrations~     of raltegravir by comparing the second trimester and third trimester drug concentrations~     with post partum.~   "
137779|NCT01251588|"~     The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced~     Autologous Chondrocyte Implantation (MACI® Implant), compared with arthroscopic~     microfracture, in patients who received study treatment in Genzyme-sponsored study MACI00206~     [NCT00719576] for treatment of symptomatic articular cartilage defects of the femoral~     condyle, including the trochlea.~   "
137780|NCT01251575|"~     This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works~     in preventing graft-vs-host disease (GVHD) in patients with hematologic malignancies~     undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and~     total-body irradiation before a donor peripheral blood stem cell transplant helps stop the~     growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. When the healthy stem cells from a donor are infused into the patient~     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,~     and platelets. Sometimes the transplanted cells from a donor can make an immune response~     against the body's normal cells. Giving total-body irradiation together with sirolimus,~     cyclosporine, and mycophenolate mofetil before and after transplant may stop this from~     happening.~   "
137781|NCT01251562|"~     The primary objective of this clinical study is as follows:~      • To determine the MTD and to assess the safety and tolerability of C31510 administered as a~     single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors~      The secondary objective of this study is as follows:~      • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single~     4-hour IV infusion (up to nine different dosages) in subjects with solid tumors~      The exploratory objectives of this study are as follows:~        -  To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral~          blood cells~        -  To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the~          effects on vascular permeability will be assessed by digital contrast enhanced~          (DCE)-magnetic resonance imaging (MRI)~        -  To evaluate tumor response (preliminary antitumor activity) after repeat administration~          of C31510~        -  Long-term safety and tolerability of C31510 after repeat administration~   "
137782|NCT01251549|"~     ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower~     limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be~     used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple~     sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.~   "
137783|NCT01251536|"~     The purposes of this study are to determine whether administering escalating doses of~     cetuximab in patients with no early skin toxicity could delay the progression of disease in~     a significant proportion of patients and to study the molecular signatures of response.~   "
137784|NCT01251523|"~     The proposed randomized clinical trial will compare two educational interventions:~     Physicians Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the~     Bronx and their 1192 patients.~   "
137785|NCT01251510|"~     PURPOSE~      The goal of the present project is to unravel the importance of bile acid-induced GLP-1~     secretion (via the G protein-coupled receptor TGR5) in human physiology.~      In the present study the investigators examine the GLP-1 secretion in healthy subjects and~     cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised~     patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1~     response as compared to healthy subjects.~   "
137786|NCT01251497|"~     The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi~     Diabetes! (Yo Puedo) diabetes self-management education program.~   "
137787|NCT01251484|"~     VEGF inhibition by BEV may induce a change in tumor invasiveness and treatment failure is~     often associated with remote metastases. BEV may stop the growth of tumor cells by blocking~     blood flow to the tumor. Cediranib, a pan-VEGF inhibitor has shown promising results in~     recurrent GBM.~      VEGF-blocking with small molecules may overcome the mechanism of resistance, and response to~     BIBF-1120 in such circumstances may open a new treatment option in GBM. In additional,~     recurrent glioblastomas have an extremely poor prognosis, so innovative therapies are~     needed.~   "
137788|NCT01251471|"~     The aim of this pharmaco-MRI study is to investigate neural correlates of variable~     antidepressant treatment response driven by genetic variation in multiple genes involved in~     depression.~      Thirty Major Depressive Disorder (MDD) patients with a concurrent major depressive episode~     will undergo three MRI scanning sessions after escitalopram treatment initiation.~     Furthermore, extensive behavioral assessments and measures of potential peripheral markers~     such lymphocyte mRNA or pharmacological parameters on platelets or lymphocytes will be~     performed.~      Imaging measures have been suggested to be superior for drug response assessment as compared~     to psychometric scales, which hardly correlate with biological parameters. Since imaging~     techniques are too expensive and sophisticated for a broad clinical use, this study will~     provide pilot data on potential peripheral biomarkers of neural activation being related to~     drug response.~   "
137789|NCT01251458|"~     This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel~   "
137790|NCT01251432|"~     This research study measures how well the Eustachian tube works and looks directly at the~     anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted~     into their eardrums because they have been diagnosed as having either otitis media or~     poor Eustachian tube function. The Eustachian tube is a biologic tube that connects the~     back of the nose to the middle ear (the airspace located behind your eardrum). That tube is~     usually closed, but can be opened by swallowing and other activities. Periodic openings of~     the Eustachian tube allow air to flow between the nose and middle ear which keeps the~     pressure of gas in the middle ear at the same level as that of the atmosphere, a condition~     required for good hearing. In children and adults, middle-ear diseases such as otitis media~     with effusion (the buildup of fluid within the middle ear) and a form of temporary hearing~     loss (conductive hearing loss) occur if the Eustachian tube does not open, does not open~     frequently enough or is always open (called a patulous Eustachian tube). A diagnosis of~     these different conditions can be made using standard, clinical tests of Eustachian tube~     function and the Eustachian tube can be visualized where it enters the back of the nose~     using a specialized telescope called an endoscope. Some scientific reports suggest that the~     cause of poor Eustachian tube function in an individual can be determined by studying the~     anatomy of the Eustachian tube at the back of the nose and the movements of the Eustachian~     tube in that area during swallowing, talking and other activities using an endoscope.~      In this study, the investigators plan to explore the relationship between the results of the~     standard Eustachian tube function tests and those for the anatomy and function of the~     Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian~     tube function. Also, there are a number other disease conditions (examples: nasal allergy,~     acid reflux disease) that are related to poor Eustachian tube function and it is possible~     that these conditions and their effect on Eustachian tube function can be treated with~     medicines. Therefore, the investigators also plan to evaluate enrolled persons for those~     conditions. It is expected that if the results of the standard Eustachian tube function~     tests can be explained by the anatomy of the back of the nose and Eustachian tube, the~     functional anatomy (movements during swallowing etc) of the Eustachian tube or the presence~     of allergy and or/acid reflux disease, new medical and/or surgical treatments can be~     developed to improve Eustachian tube function and cure or treat the associated middle-ear~     diseases.~   "
137793|NCT01251393|"~     Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15~     and 64 years old. The drug dependence has been described by many authors as a dysfunction of~     the brain reward system. Considering the effects of the cholinergic system on the drug~     reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on~     cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a~     cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug~     dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50~     years old will be study. This is a double-blind controlled and randomized placebo study. All~     the patients will be treated with brief intervention therapy (BIT), and half of them will~     receive biperiden (6mg/day) while the other half will receive placebo. The treatment~     efficacy will be evaluated through the comparison between the values obtained on the~     following measures before and after the treatment: Craving scale of Minnesota and~     Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite~     (benzoylecgonine) on urine.~   "
137794|NCT01251380|"~     The purpose of this research study is to determine whether repeat treatments with Dysport®~     are safe and effective in the treatment of increased stiffness of the calf muscles and~     whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.~   "
137795|NCT01251367|"~     The purpose of this research study is to assess the long term safety of Dysport in~     hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over~     repeated treatment cycles.~   "
137796|NCT01251354|"~     The purpose of the protocol is to determine the effect of BN83495 on the progression of~     endometrial cancer with estrogen receptor in post menopausal women who had previously~     received chemotherapy.~   "
137797|NCT01251341|"~     The increasingly widespread use of meditation for stress-related emotional and medical~     conditions highlights the urgent need to rigorously evaluate mechanisms through which the~     benefits of practice might be conferred. Primary challenges in this regard include~     evaluating dose response relationships between practice time and outcomes; clarifying~     whether physiological and behavioral effects of meditation derive primarily from~     non-specific aspects of training or result from specific meditation practices; and~     identifying molecular mechanisms by which meditation might affect physiological responses~     relevant to stress-related illness. Recent findings from a cross-sectional study by our~     group indicate that young adults who are randomized to, and practice, compassion meditation~     demonstrate reduced inflammatory responses, less emotional distress, and reduced autonomic~     responses to a standardized laboratory psychosocial stressor (Trier Social Stress Test~     [TSST]) when compared to subjects randomized to an active control condition. However, as a~     result of the cross-sectional study design and lack of a meditation comparator arm, these~     results provide only partial insight into key issues outlined above regarding the role~     played by specific meditation procedures and/or practice time in observed physiological and~     behavioral outcomes. The primary hypothesis of the proposed work is that practicing a~     meditation procedure specifically designed to enhance empathic concern for others (i.e.~     compassion meditation) will optimize autonomic reactivity to psychosocial stress in a manner~     that results in diminished activation of peripheral inflammatory signaling pathways and~     reduced behavioral distress.~   "
137798|NCT01251328|"~     Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are~     considered to be too sick for conventional aortic valve replacement. There is no conclusive~     opinion about the best anesthesiologic management of these patients. Sedation and general~     anaesthesia are both adequate and the current literature shows no benefit towards one of~     these methods.~      This study wants to investigate the influence of these two anesthesiologic managements on~     the cerebral oxygen saturation during the rapid pacing-period during valvuloplasty. The~     patients are randomised allocated to one of these two anaesthesiological managements. The~     investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen~     saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral~     hypoxia.~   "
137799|NCT01251315|"~     Glutathione is a powerful protective substance found within every cell in the body. It has~     been shown that glutathione levels go down as a person gets older, which makes a person more~     likely to get heart disease, high blood sugar problems and different kind of cancers.~     N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase~     glutathione levels in the body. The diet supplement called ProImmune is also changed by the~     body into glutathione. Therefore, the purpose of this study is to find out the effect of~     ProImmune in healthy people. This study will also help to prove whether or not the ProImmune~     is able to improve the blood levels of glutathione in healthy people.~   "
137800|NCT01251302|"~     To investigate whether the use of a gene expression score blood assay changes the diagnostic~     testing pattern in patients referred to a cardiologist for the evaluation of chest pain or~     anginal equivalent symptoms.~   "
137801|NCT01251289|"~     A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients~     in an Inner City Tertiary Care Center~   "
137802|NCT01251276|"~     Primary objective:~      => To describe the Seroprotection rate (SPR) at least 2 years following completion of a~     primary series with an Hepatitis B vaccine and 1 month following a challenge dose of~     HBVaxPro.~      Secondary Objective:~      => To describe the safety and tolerability of a challenge dose of HBVaxPro in adults ≥50~     years of age.~   "
137814|NCT01251120|"~     This randomized, open-label, parallel-group study will assess the effect on disease~     remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying~     antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in~     patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly~     assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra~     intravenously every 4 weeks. The anticipated time on study treatment is 12 months.~   "
137815|NCT01251107|"~     The choice of a preferred first-line treatment requires balancing the desire for optimal~     disease control with the occurrence of early and late treatment-related effects. To fully~     assess this balance, the treatment decision process should ideally take into account the~     outcome following a consistent second-line therapy, in particular when tolerated, widely~     applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing~     initial chemotherapy.~   "
137803|NCT01251263|"~     This study will examine the combined effects of a continuous oral contraceptive (OC) regimen~     with supplemental estradiol therapy on headache severity and occurrence in subjects with~     documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will~     have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal~     contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen~     following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,~     the subject will institute a 4-day hormone-free interval (HFI). In an attempt to~     prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral~     estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous~     pills, the subject will institute a 4-day HFI during which they will be randomized into~     estradiol or placebo groups.~      The purpose of this research study is to examine the effects of continuous oral~     contraceptive pills and oral estradiol on headaches that occur around the time of your~     period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped~     they may get headaches. This study will examine if taking estradiol around the time of the~     period will affect the headache, and how it will be affected.~      This study is a prospective trial. A subject's participation will last approximately 32~     weeks.~   "
137804|NCT01251250|"~     RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic~     leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of~     Azadirachta indica in treating patients with chronic lymphocytic leukemia.~   "
137805|NCT01251237|"~     It is particularly important that thorough gut cleansing is achieved prior to the~     colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E)~     solutions are well established as safe and effective agents for gut cleansing and Norgine~     has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy~     and safety of this solution is similar to the standard 4 litre PEG+E, but with improved~     patient acceptance.~      Tolerance, acceptability and satisfaction with the cleansing agent plays an important role~     in subjects' compliance with gut preparation procedure. The study medication NRL0706 is~     identical to the PEG+E-containing gut lavage solution commonly used in clinical practice,~     with the exception that the flavour has been modified from lemon to orange. This study is to~     investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706~     (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for~     colon cancer screening.~   "
137806|NCT01251224|"~     The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen~     exposure in mouse allergic children with asthma and mouse allergen exposure. Participants~     will be randomized to either the Integrated Pest Management (IPM) Group or the Education~     Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters,~     allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group~     will receive education about IPM at the beginning of the trial and then after completion of~     the trial, will receive the IPM intervention. Participants will be followed for 12 months.~   "
137807|NCT01251211|"~     Pain due to peripheral nerve lesion remains extremely difficult to treat and current~     treatments have onl moderate efficacy and/or side effects. The investigators have previously~     demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of~     patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to~     a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with~     peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its~     mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second~     injection is associated with a therapeutic gain. This will be a randomized placebo~     controlled study. A total of 30 patients will be randomized to receive either BTX-A~     (subcutaneous injection in the painful area) or placebo. Each injection will be repeated~     within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be~     performed before and 1 month after BTX-A administration. The investigators postulate that~     this study will confirm the clinical efficacy and good safety of repeated administrations of~     BTX-A in the treatment of peripheral neuropathic pain.~   "
137808|NCT01251198|"~     Observatory multicenter, prospective, to support the acute phase of acute coronary syndromes~     with ST segment elevation ST (myocardial infarction).~   "
137809|NCT01251185|"~     Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves~     for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.~   "
137810|NCT01251172|"~     This phase II clinical trial is studying how well gamma-secretase/Notch signalling pathway~     inhibitor RO4929097 (RO4929097) after autologous stem cell transplant works in treating~     patients with multiple myeloma. Giving chemotherapy, such as melphalan, before autologous~     stem cell transplant stops the growth of cancer cells by stopping them from dividing or~     killing them. Before treatment, stem cells are collected from the patient's blood and~     stored. After chemotherapy, the stem cells are returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy. RO4929097 may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth. Giving RO4929097~     after autologous stem cell transplant may kill more cancer cells.~   "
137811|NCT01251159|"~     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may~     help doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This laboratory study is studying bone marrow samples from patients with acute~     myeloid leukemia.~   "
137812|NCT01251146|"~     This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the~     effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous~     system's (SNS) activity in subjects with essential hypertension.~   "
137813|NCT01251133|"~     This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study~     to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus~     toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same~     vaccination with primary one in healthy toddlers who completed the primary vaccination with~     LBVH0101 or Hiberix™ in LG-VHCL002 study.~   "
137827|NCT01250951|"~     This study will evaluate the efficacy and safety of deferasirox in patients with MDS,~     thalassemia and rare anemia patients with transfusion iron overload.~   "
137816|NCT01251094|"~     Background~      Cognitive impairment in Parkinson's disease (PD) is common, even in the early stage of this~     disease.The cumulative prevalence of dementia associated with Parkinson's disease (PDD) is~     as high as 80% in a recent 8-year prospective study. However, some kinds of cognitive~     impairment are not apparent and the value of self-report cognitive decline became limited.~     In other words, some cognitive impairment may be detected by cognitive tests rather than~     self-report of the symptoms.The early intervention of the cognitive impairment may be~     helpful for these patients. Neuropsychiatric symptoms(NPSs) are also common in PD and PDD~     patients. The severity of NPSs contributes to reduced quality of life and distress for~     caregivers. Previous studies showed some different clinical phenotypes of NPSs in PD or PDD~     patients. Among the NPSs, hallucination was considered a critical factor of cognitive~     dysfunction in PD and PDD patients. The co-occurrence of NPSs in PD and PDD patients has~     limited evidence now.~      Purpose~      To establish the screening tools for early detecting the PD patient with cognitive~     impairment; exam the diagnostic value of MoCA and other cognitive tests in PD with mild~     cognitive impairment, possible PDD, and probable PDD; understand neuropsychiatric symptoms~     (NPSs) in these different patient groups; exam the relationship between each NPS and each~     domain of cognitive dysfunction.~      Methods~      In order to exam the cognitive dysfunction in PDD (attention, executive function,~     visuo-spatial function, and memory), several tests are performed. A 32-item cognitive~     decline questionnaire will be used to screen the cognitive impairment in subjects.~     Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA)are used for~     cognitive evaluation. The detail evaluation of each domain is specified asfollowing: (1)~     Attention (WAIS-R digit span), (2) Memory (12-item word recall test),(3) Executive function~     (category verbal fluency), (4) Visuospatial function (cube copying and clock drawing). The~     motor symptoms severity of the PD will be evaluated by the Hoehn & Yahr stage and motor~     portion of the Unified Parkinson's Disease Rating Scale (UPDRS). The neuropsychiatric~     symptoms will be recorded by Neuropsychiatric Inventory Questionnaire (NPI-Q). The daily~     living activity will beevaluated by modified Lawton's instrumental activities of daily~     living scale (IADL)and pill questionnaire. Subjects also receive 15-item Geriatric~     Depression Scale(GDS-S) to evaluate the mood status. The clinician's diagnosis of dementia~     will be based on the diagnostic criteria of DSM-IV, which will be compared with the~     PDDdiagnostic criteria proposed by MDS in 2007. The investigators will also try to develop a~     PDDscreening questionnaire.~      Expected results~      Cognitive impairment and dementia of PD patients will be ascertained by the cognitive test~     battery. The screening questionnaire will be established. The heterogeneity of NPSs in PD~     and PDD will be evaluated. The PDD screening questionnaire will help the clinician to~     diagnose the patients.~   "
137817|NCT01251081|"~     In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from~     50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.~   "
137818|NCT01251068|"~     Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside~     investigation of cerebral oxygenation in newborn infants. Using this technique we~     investigated the relationship between changes in cerebral oxygenation and hemodynamics, and~     changes in some physiological variables during blood transfusion in anaemic preterm infants.~   "
137819|NCT01251055|"~     The etiology of schizophrenia remains unclear In recent one decade, hypofunction of~     N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of~     schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for~     schizophrenia treatment.~      To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult~     clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still~     unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety~     of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for~     treatment response to NMDA enhancers.~   "
137820|NCT01251042|"~     The study is an open, randomized, controlled, single-centre study including a total of 42~     evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of~     800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect~     blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of~     blood has been collected, the subject will be randomized to either be retransfused with the~     blood collected (investigational group) or not (control group). The primary objective for~     this study is to investigate the blood quality and isolate the systemic effects in~     intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the~     primary outcome variable based on previous experience and literature and is considered as~     the major safety concern for the study subjects.~   "
137821|NCT01251029|"~     Acute kidney injury (AKI) is one of the most serious and frequent complication of general~     anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI.~     CKD patients often need some surgical interventions that have been done under general~     anesthesia; they therefore have an increased probability to develop AKI.~      N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties,~     reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury~     and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney~     from injury induced by contrast media, ischemia, and toxins.~      Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in~     renal functioning in CKD patients undergoing major surgery under general anesthesia.~      Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40)~     patients that should undergo surgical interventions under general anesthesia and will divide~     to 3 groups as follows: group 1- about 40 patients which should undergo major vascular~     surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery~     (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major~     abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and~     B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery.~     Subgroup B will receive placebo (saline).~      Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL~     (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after~     surgery in all patients. An additional blood samples for assessment of nitric oxide and~     cytokine levels will be taken from each patient before and after surgery.~   "
137822|NCT01251016|"~     Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been~     associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to~     treat severe obesity, and its metabolic benefits can lead to early and complete remission of~     T2DM, even before a considerable weight loss. We have hypothesized that intestinal anatomic~     changes may change intestinal genes expression related to glycemic control. The knowledge of~     mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of~     action in bowel may eventually help to develop alternative, less invasive and safer surgery~     for the treatment of T2DM, as well as drug development for the newly targets identified.~   "
137823|NCT01251003|"~     The purpose of this study is to determine if it is safe to use stored autologous Human~     Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate~     Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow~     Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.~   "
137824|NCT01250990|"~     This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy~     volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer~     activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is~     that niacin augments reverse cholesterol transport.~   "
137825|NCT01250977|"~     The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept),~     for adherence, side effects and effects on smoking behavior in a population of dependent~     smokers.~   "
137826|NCT01250964|"~     The purpose of this study is to determine if there is any difference in astigmatism (eye~     surface curvature) or corneal endothelial cell density (the inner cell lining of the eye~     surface) after two different methods for inserting a lens during cataract surgery.~   "
137830|NCT01250912|"~     Some patients are at risk for life-threatening fast heart rates. These can frequently be~     treated by using a catheter inside the heart to burn away the cells that create the fast~     heart rates. The purpose of this study is to image the nerves inside the heart of those~     patients. The investigators want to find out if abnormalities in the nervous system in the~     heart can help the physician to find the area that needs to be burnt away.~   "
137831|NCT01250899|"~     This is a research study to look at vitamin D deficiency (low levels) in men and women with~     HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If~     your levels are low, and you choose to start using vitamin D supplements, the investigators~     would like to take some blood before and after you start using vitamin D to see how this~     affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators~     will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study.~     If you and your physician decide that you should continue taking vitamin D supplements after~     that time, you will be responsible for purchasing your own vitamin D supplements.~   "
137832|NCT01250886|"~     The purpose of this study is to determine whether fluid administration in patients~     undergoing colonoscopy should affect acid-base disorder in term of the strong ion~     differences.~   "
137833|NCT01250873|"~     LY2216684 is being studied as adjunctive treatment for MDD in patients who are partial~     responders to SSRIs. Sertraline is a medication that is widely used to treat MDD and it is a~     known substrate of CYP450s, including CYP2D6, CYP2C19 and CYP3A4, and a modest inhibitor of~     CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its~     elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not~     result in a substantial change in the PK profile of LY2216684. LY2216684 is only known to be~     a moderate inhibitor of CYP2C19 so it is unlikely that coadministration of sertraline with~     LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study~     is being conducted to test these hypotheses.~   "
137834|NCT01250860|"~     The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on~     the function of the respiratory system and the morphology of the ribcage in short-term~     intensive physiotherapy.~   "
137835|NCT01250847|"~     The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal~     learning ability in people with at-risk mental state (ARMS) over a 12 week period. The~     verbal learning ability will be indexed by delayed free recall score of CVLT(California~     Verbal learning Test), a standard neuropsychological verbal memory tests.~      The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive~     function and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity.~     The cognitive function abilities will be measured by standard neuropsychological tests as~     follows;~        -  Working memory: verbal & spatial 2-back test~        -  Attention: Digit Span, 3-7 CPT(Continuous Performance Test)~        -  Executive function: WCST (Wisconsin Card Sorting Test)~        -  Visuo-spatial ability: Rey Complex Figure Task copy~        -  Visuomotor speed and planning: Trail making test A & B~        -  Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric~          symptoms which will be used are as follows;~        -  Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome~          scale (PANSS)~        -  Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)~        -  Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)~        -  Impulsivity: Barrett Impulsivity Scale (BIS)~   "
137836|NCT01250834|"~     This study will assess if giving LY2189265 at the same time as atorvastatin affects how the~     body absorbs atorvastatin.~   "
137837|NCT01250821|"~     Ovulation disorders are a common cause of infertility in women. Most of these women can be~     classified as World Health Organization (WHO) Group II anovulatory patients as they have~     irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation~     hormone (FSH) and estradiol.~      The purpose of this study is to optimize the low-dose-step-up protocol traditionally used~     for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory~     infertility WHO Group II.~      Previous studies have established that menstrual cycle history, mean ovarian volume and BMI~     are significant predictors of FSH threshold dose in women with anovulatory infertility WHO~     Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram~     has been constructed based on these variables.~      The aim of this study is to evaluate the clinical use of the nomogram in order to test the~     use of the variables to determine whether an individualized starting dose of FSH can be used~     for ovulation induction in anovulatory patients.~      It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the~     disadvantages of the treatment and that the stimulation period of the individualized~     nomogram-based treatment will be 25% shorter than observed in the standard protocol.~      The primary endpoint is the proportion of patients who reach the criteria for~     hCG-administration within 14 days of Menopur stimulation. The results of the study will be~     compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al.,~     2006).~   "
137838|NCT01250808|"~     Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The~     previous study pointed out that the dosage and course of Bortezomib including the dose of~     concomitant drugs used to treatment MM patients did not get the preferred treatment program,~     so we are going to determine the optimal doses and course of Bortezomib through the~     prospective, multicenter clinical trial and evaluate the efficiency and safety of different~     program.~   "
137839|NCT01250795|"~     The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1~     Vaccine in healthy adults.~   "
137840|NCT01250782|"~     Recent reports suggest that most beneficial results of glutamine have been obtained with the~     parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group~     of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not~     often used in critically ill patients.~      The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU~     patients can reduce the number of infections, ICU length of stay and mortality.~      This benefit can be achieved independently the type of nutrition (enteral or parenteral~     nutrition), being a pharmaconutrient.~   "
137841|NCT01250769|"~     This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning~     modalities on oral health.~   "
137842|NCT01250756|"~     Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group~     1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular~     pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up~     doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to~     demonstrate that the immune responses as measured by serum antibody responses to diphtheria~     toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by~     DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP~     given alone. In addition, the study aims to evaluate the side effects (safety profile) after~     vaccination of 7vPnC when given with DTaP in healthy Japanese infants.~   "
137843|NCT01250743|"~     The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c),~     given intravenously to patients with chronic hepatitis due to infection with the genotype 1~     version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of~     virus circulating in the patients' blood.~   "
137844|NCT01250730|"~     The purpose of this study is to investigate the pharmacokinetics of single doses of~     PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male~     volunteers.~   "
137845|NCT01250717|"~     The purpose of this research study is to determine if the combination of chemotherapy and~     hormone therapy is safe and helpful for patients who plan to have their high-risk prostate~     cancer surgically removed. Some physicians believe that patients with high risk cancer that~     is located in one area, may have an early but small spread of the cancer outside of the~     prostate, and perhaps even to distant organs. Therefore, better treatments for the entire~     body are needed to improve the ability of surgery or other local therapies to cure prostate~     cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced~     prostate cancer patients, it is possible that using chemotherapy combined with hormonal~     therapy earlier in the course of localized but high risk patients might improve the outcomes~     for these patients.~   "
137846|NCT01250704|"~     Neuromyotonia (NMT), so called Isaac's syndrome, is a rare disorder in which~     hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. It~     is characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis,~     paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia.~     Electromyographic recording is a key diagnostic tool in detecting myokymia and~     neuromyotonia. Pathophysiology of neuromyotonia is claimed to be related immune disorder,~     autoimmune anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium~     channel. KCNA1 (Kv1.1) mutation was mostly reported in a autosomal dominant trait. In the~     present study, we report a family affected with myokymia，worsening with elevated body~     temperature, febrile illness or spicy food. How the change in temperature influence clinical~     features of channelopathies is an interesting topic. Variant clinical severity of family~     members are recorded. The index patient has possible autoimmune mechanism involvement~     because of his clinical feature of myasthenia gravis with thymoma and hyperthyroidism.~     Further analyzing the genetic mutation in potassium channelopathy may provide researchers~     some pathophysiological insight into the Isaac's syndrome.~   "
137847|NCT01250691|"~     This study will carry out in the ICU. Objectives of the study are to determine the frequency~     of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.~   "
137848|NCT01250678|"~     Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our~     knowledge about long term development of cognitive performance under natalizumab therapy is~     limited. We want to demonstrate with this study that patients treated with ntz improve in~     neurocognitive tests over the long term.~   "
137849|NCT01250665|"~     This study is a cross sectional study of patients diagnosed with clinically isolated~     syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment,~     fatigue severity and depressive symptoms. Cognitive impairment will be assessed with~     Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT),~     fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions~     (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned~     above are validated for MS patients. In the second step we will use our large longitudinal~     database of serial MRI examinations from which a linear measurement of CCI will be~     retrospectively calculated.~   "
137850|NCT01250652|"~     Allen Kaplan is a prominent American allergist with the reputation of leader in the field of~     chronic urticaria. He advocates treatment with first generation hydroxyzine, which he~     considers at least as effective as modern second generation H1-blockers in suppressing the~     symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He~     further speculates that hydroxyzine may have the advantage to better suppress itch and~     improve nighttime sleep. This has prompted many practitioners around the world to believe~     that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to~     patients. At the same time European guidelines indicate modern second generation H1-blockers~     in higher than conventional doses as drugs of choice for such cases. However, there is no~     evidence from clinical trials addressing this controversy. The investigators' previous~     studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to~     treat urticaria by reducing lesions and itch, improving quality of life and night time~     sleep, while not causing day time somnolence. First generation H1-receptor antagonists and~     hydroxyzine among them are known to penetrate the blood / brain barrier and to cause~     sedation. The question stays whether this sedation is beneficial to the subjects with~     chronic urticaria at night, whether it has any hang-over unwanted effects the following day~     and whether this has any influence on the overall urticaria-specific quality of life.~   "
137851|NCT01250639|"~     This study is a cooperative project and aims to identify genetic components associated with~     type 2 diabetes mellitus (T2DM), which is significant for the population of non-aboriginal~     Taiwanese.~   "
137852|NCT01250626|"~     Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the~     body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the~     glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is~     excreted almost entirely by glomerular filtration. Inulin clearance is considered to be~     identical to glomerular filtration rate (GFR).~   "
137853|NCT01250613|"~     Genomic aberrations in patients diagnosed as congenital malformation with unknown etiology~     will be identified using high-density oligonucleotide array.~   "
137854|NCT01250600|"~     Although a lot of evidence and guidelines recommend that patients have cardiac~     rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation~     program is low, usually less than one third. One of the main hindrances of patients~     participating cardiac rehabilitation program is insufficient number of medical institutions~     that can provide rehabilitation services. Patients usually cannot perform exercise program~     under medical professionals monitoring without having to go far. This spatial and temporal~     difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk~     of patients to do exercise is higher than healthy adult.~      This project will develop the intelligent portable remote care system for cardiopulmonary~     exercise to provide an instant ECG monitoring service through the integration of front-end~     wireless ECG measuring devices, expert system, and back-end tele-care platform. Many~     patients are inconvenient to go to large hospital regularly for cardiac rehabilitation~     training. This project will help them to exercise at home after once or twice rehabilitation~     training in clinic for each month and the medical professional will supervise remotely to~     see how much exercise they did. For that reason the project can help to break through~     spatial and temporal difficulty of having cardiac rehabilitation, so that cardiac~     rehabilitation can be help more patients. Patients have this tele-care system while they are~     doing exercise at home, the built-in heart rate and cardiac rhythm warning function will~     remind them to take a break, even to take medical treatment. More importantly, the ECG~     signal can be almost immediately (real time) uploaded by network to the chest pain unit of~     hospital. The cardiology expert will be aware of the warning at the first moment. This is an~     important protection to patients' safety of doing rehabilitation sports at home.~      This randomized control trial will recruit 80 patients who had myocardial infarction within~     6 weeks, and are not able to attend a hospital based cardiac rehabilitation program~     regularly. All patient will undergo a three-month home exercise program under the~     instruction provided by the physiatrists and physiotherapists. Forty of them (the~     remote-care group) will use the intelligent portable remote care system for cardiopulmonary~     exercise to monitor their exercise intensity and cardiac rhythm during exercise. The other~     40 patients (the control group) undertake the exercise program at home without using the~     remote care system. The efficacy and safety of exercise program will be compared between the~     two groups.~   "
137855|NCT01250587|"~     The purpose of this study is to determine a safe and effective dose range for intravenous~     administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in~     patients with primary dysmenorrhea.~   "
137856|NCT01250574|"~     Postoperative complications, especially bacterial infections, are relatively common and~     cause increased morbidity and mortality. Effective and timely antimicrobial treatment is~     important for prognosis, and delayed diagnosis and treatment substantially increase~     mortality. The early diagnosis of infection and sepsis are today based on diagnostic tests~     that have been available for years, like WBC count, SR and CRP. These markers suffer from~     several drawbacks; their sensitivity and specificity for infection and sepsis are not good~     enough and their kinetics are rather slow in terms of both increase and decrease. A major~     disadvantage of CRP is that after surgery and trauma this marker generally increases for~     several days, reaching a plateau typically on day 2-4 following the event, and therefore, in~     most cases do not offer the needed guidance for early treatment of bacterial infection. More~     recently, other biomarkers for infection and sepsis have become available, some of which~     appear acceptable for diagnostic use. Procalcitonin (PCT) and neutrophil CD64 are both~     promising new markers for the early detection of infection. They do both have their pros and~     cons compared to each other and compared to the traditional markers, such as CRP and WBC~     count. It is a general view that further research is needed before these markers will be~     accepted as part of the routine protocol for the diagnosis of infections, especially in~     relation to postoperative complications. The aim of the present study is to investigate the~     clinical utility of procalcitonin (PCT) and neutrophil CD64 as markers for infection and~     inflammation:~        -  to evaluate if it is possible to detect early phase postoperative infections by using~          these tests versus traditional markers such as CRP, SR and WBC count (with~          differential).~        -  to differentiate between systemic bacterial infection and systemic inflammation due to~          the surgical trauma.~      The hypothesis is that PCT and neutrophil CD64 are more sensitive and specific analysis for~     the early detection of infection after abdominal surgery than CRP (and other widely used~     tests for inflammation and infection), and that neutrophil CD64 is more specific than PCT.~     Patients admitted to the Department of Gastroenterological Surgery, Akershus University~     Hospital for elective abdominal surgery will be included in the study after informed~     consent. Initially consecutive series of 150 patients will be included, but this number may~     be increased depending on the number of observed infections during the course of the study.~     All patients will be monitored and treated by the formal protocol related to clinical signs~     of infection, such as abcess, peritonitis, pneumonia, sepsis and septic shock. In addition~     to the analytical parameters routinely used today in order to discover infections (CRP, WBC~     count etc), blood samples for PCT and neutrophil CD64 will be analyzed before surgery and~     daily during the stay at the hospital. In the case of signs of infection, locally or~     systemic, the frequencies of analysing PCT and CD64 will be increased according to the~     severity of the changes in the clinical condition. The expression of CD64 will be measured~     by flow-cytometry and PCT will be measured by an immunochemical method.~   "
137857|NCT01250561|"~     The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in~     acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.~   "
137858|NCT01250548|"~     The purpose of this study is to compare the effects of apremilast with a placebo (an~     inactive substance that looks like apremilast) on you and other people with rheumatoid~     arthritis.~      The investigators will be collecting information in this study to help us determine -~        -  the safety of apremilast in patients with active rheumatoid arthritis~        -  how long it takes for patients with active rheumatoid arthritis to respond to~          apremilast~        -  how long the effects of apremilast last after the treatment has ended.~   "
137859|NCT01250535|"~     Drug-drug interactions play an important role in clinical adverse events due to the~     prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded~     substantially in the US over the last decades. The purpose of this study is to develop a~     mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the~     interaction between warfarin and statins. This study will test the hypothesis that~     lovastatin potentiates the anticoagulant effect of warfarin by inducing vitamin~     K-metabolizing enzyme CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.~   "
137860|NCT01250509|"~     The purpose of this study is to determine whether a mindfulness-based stress reduction and~     mindful eating program will lead to reductions in abdominal fat and total weight and improve~     cell aging in overweight and obese women compared to a waitlist control group.~   "
137861|NCT01250496|"~     The routine administration of 75 mg of intravenous aminophylline following regadenoson~     (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce~     the gastrointestinal (diarrhea and stomach upset) and other side effects related to~     regadenoson.~   "
137862|NCT01250483|"~     The correlation between the change of serum prostate-specific antigen (PSA) or PSA velocity~     (PSAV) and severity of lower urinary tract symptoms (LUTS) has been poorly understood.~     Previous studies usually focused on the treatment efficacy or preventive role of alpha~     blockers (AB) for clinical progression of benign prostatic hyperplasia (BPH) and AB therapy~     in real-life practice improved BPH/LUTS and reduced the risk of overall clinical~     progression. We hypothesized that the change of PSA and PSA velocity would be correlated to~     LUTS severity in the groups of BPH and prostate cancer.~   "
137863|NCT01250470|"~     This phase I trial studies the side effects of vaccine therapy when given together with~     sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide~     may help the body build an effective immune response to kill tumor cells. Colony-stimulating~     factors, such as sargramostim, may increase the number of white blood cells and platelets~     found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a~     better treatment for malignant glioma.~   "
137864|NCT01250457|"~     The purpose of this research is to find out if the use of topical timolol 0.5% solution~     applied twice daily will help to shrink rosacea lesions around the eye.~   "
137865|NCT01250444|"~     The purpose of this study is to determine inspiratory muscle training effects on blood~     pressure, functional capacity and quality of life in hypertensive patients.~   "
137866|NCT01250431|"~     The purpose of the study is to measure the change in psychological symptoms and gene~     expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have~     shown statistically significant reductions in depression, anxiety, and PTSD in veterans~     after EFT, and this study extends earlier research using biological sampling. EFT is a form~     of Energy Psychology (EP) that is sometimes referred to as emotional acupuncture. It~     involves self-stimulation of 14 acupuncture points at the end of meridians with the~     fingertips, while recalling an emotional event such as a combat trauma. It is typically~     effective in 6 to 15 coaching sessions, making it an efficient clinical technique for~     reducing affect.~   "
137867|NCT01250418|"~     The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS~     Monitor during sedation with ketamine?~      The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence~     of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the~     use of ketamine.~   "
137868|NCT01250405|"~     The primary objective is to determine whether reduction of serum calcium concentration by~     cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary~     objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV),~     2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.~   "
137869|NCT01250392|"~     The goal of this project is to see if behavioral nudges will increase an individual's~     likelihood of participating in a nurse visit. The behavioral nudges under consideration are~     encouraging subjects to make an active choice and sending reminders.~   "
137870|NCT01250379|"~     This randomized, open-label, parallel-group study will assess the efficacy and s afety of~     Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second-~     and third-line therapy in patients with locally recurrent o r metastatic breast cancer~     progressing after first-line therapy with Avastin and chemotherapy. Patients will be~     randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks~     intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study~     treatment is until third-line disease progression or unacceptable toxicity occurs.~   "
137871|NCT01250366|"~     The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple~     Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve~     Subjects.~   "
137872|NCT01250353|"~     The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue.~     The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium~     surgery, could be an alternative therapeutic resource to this process.~   "
137873|NCT01250340|"~     In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in~     the management of hyperglycemia, but it has not been achieved a similar result in the~     reduction of the atherosclerotic syndrome. The comprehension of the mechanisms that link~     over nutrition to inflammation and innate immune response can be important to understand the~     relationship between insulin resistance, diabetes mellitus and endothelial dysfunction. It~     will be investigated: 1) the role of Toll Like Receptors (TLR)s in the pathophysiology of~     T2D and associated atherosclerosis; 2) the role of aspirin and nicotinamide adenine~     dinucleotide phosphate (NADPH) oxidase inhibitor/s in the production of TxA2 and~     F2-isoprostanes in T2D patients; 3)new biomarkers associated to Diabetes and atherosclerosis~     including markers of endothelial dysfunction and cytokines.~      It will be analyzed in isolated platelets from normal controls and/or diabetic patients the~     production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and~     NADPHoxidase inhibitors.~   "
137874|NCT01250327|"~     This prospective interventional study is designed to evaluate the cost/advantage ratio in~     the treatment of lesions of the right ventricular outflow tract using transcatheter~     pulmonary valved stent (Melody).~   "
137875|NCT01250314|"~     Rational: Osteoporosis in men is responsible for one third of fragility fractures. However~     the definition and especially the determinants of fracture in humans are less well known~     than in women.~      Primary Objective: To search radiologic, biochemical, genetic and micro-architecture bone~     factors associated to fractures in men with low bone density.~      Study design: case/control study (fracture vs. no fracture) with men selected according to~     low bone density (Z-score<-2).~      Eligibility criteria: Included subjects will be men whose age is ³ 40 and £ 70 years with a~     Z-score< -2 at least at one of the 3 measured sites (wrist, lumbar spine, femoral neck).~     Subjects with secondary osteoporosis will be excluded (corticosteroid treatment,~     hypogonadism, …) Progress of the study: The recruitment will be over two years. The study~     will include two periods, an inclusion visit and a period of 3 months to achieve~     radiological and biological examinations. The subjects will be recruited in the 3~     rheumatology departments (LARIBOISIERE, COCHIN). Subjects will be investigated at~     LARIBOISIERE hospital to perform radiological examinations and biological sampling for~     laboratory tests within 3 months of enrollment.~      Evaluation criteria: Biochemistry: dosages of sexual steroids, bone remodeling markers and~     homocysteine; Genetic: evaluation of polymorphism of candidates genes associated to~     fragility fractures (collagen type I, homocysteine, LRP5); Radiology: evaluation of bone~     micro-architecture with a scan of lumbar spine and hip and peripheral micro-scan (XTREME~     sSCANCO) and bone densitometry at spine, femoral neck and wrist.~      Duration of participation: there is no follow up Total duration of the study: 2 years and 3~     months. Number of subjects: 100 patients with fracture and 100 controls without fracture~   "
137908|NCT01249872|"~     Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery~     for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia~     has been studied, but up to date no data are available concerning the use of thoracic~     epidural patient-controlled analgesia regarding the use of levobupivacaine combined with~     morphine in morbidly obese patients. The investigators' aim in this prospective, randomized,~     double-blinded study was to compare the analgesic effectiveness, the dose requirements and~     side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine~     combined with a continuous epidural administration of morphine, with or without a loading~     dose, after open gastric bypass for morbid obesity.~   "
137970|NCT01249066|"~     AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves~     as an energy guardian to help cells adapt to various metabolic stress including hypoxia.~     Because the role of AMPK in cancers has not been fully elucidated, in this study we~     investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and~     tissue.~   "
137876|NCT01250301|"~     The aim of this study is to determine if using a behavioural replacement for smoking~     (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two~     weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of~     abstinence. Two hundred smokers who want to quit will be recruited from the community. They~     would all receive standard smoking cessation treatment from the NHS Stop Smoking Service~     (NHS SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement~     therapy, Champix) and motivational support. On their target quit date, participants would be~     randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus~     standard treatment for the first two weeks of their quit attempt, or to continue with~     standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes~     except that they do not deliver nicotine to the smoker. Participants will rate their urges~     to smoke at each week. Standard NHS SSS measures will also be taken in addition to user~     acceptability ratings and reactions to smoking cues.~      The hypothesis is that complementing current NHS SSS treatments with de-nicotinised~     cigarettes, to address the non-nicotine factors associated with smoking and to help~     extinguish smoking behaviour, would result in lower urges to smoke than standard treatment~     alone.~   "
137877|NCT01250288|"~     The purpose of this research study is to describe the usage of consumers and providers when~     using a novel technology designed to give consumers the ability to manage and access their~     health information. This is a quantitative descriptive analysis study.~   "
137878|NCT01250275|"~     The fatty acid composition of canola oil will have beneficial acute and chronic effects on~     vascular function in individuals with peripheral arterial disease.~   "
137879|NCT01250262|"~     The purpose of this study is to determine if a 4 month resistance exercise program reduces~     the severity of low back pain, pain-related fear avoidance and improves mobility compared to~     standard care.~   "
137880|NCT01250249|"~     To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private~     Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120~     healthy children.~   "
137881|NCT01250236|"~     Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is~     widely used in glaucoma treatment. Although it is known that it is quickly taken up by the~     cornea following topical administration and that the cornea has alpha-2 adrenoceptors there~     are only few studies available on the impact brimonidine has on the cornea. The aim of the~     study is to find out~        1. whether topical administration of brimonidine results in interaction with corneal~          alpha-2 adrenoceptors in terms of an increase in corneal thickness and~        2. whether there are any differences between the response corneal epithelium, stroma and~          endothelium show to alpha-2 adrenoceptor stimulation.~   "
137882|NCT01250223|"~     The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic~     Factors Project which permitted the development of the Follicular Lymphoma International~     Prognostic Index (FLIPI).~      The F2-study is designed as a prospective collection of information potentially useful to~     predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are~     to validate the FLIPI and to verify whether a prognostic collection of data would allow the~     development of a more accurate prognostic index.~   "
137883|NCT01250210|"~     The primary objective was to evaluate the adequacy of ovulation suppression, cycle control,~     and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2~     different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE)~     during 3 consecutive cycles of administration of each treatment.~   "
137884|NCT01250197|"~     This is a double-masked, single-center, crossover study in which normal volunteers will be~     randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8~     days. Subjects will undergo a minimum 7-day washout, and then receive the alternate~     treatment for 8 days.~   "
137885|NCT01250184|"~     Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a~     common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the~     effectiveness of different treatments such as exercise, injection but not comparing them~     with each other. The objective of this research was to demonstrate whether lidocaine~     injection into trigger points combined with a physical therapy program was more effective~     than each separatetreatment in improving pain, function and quality of life in a group of~     patients with myofascial pain syndrome (MPS) of the shoulder girdle and cervical region.~      Design: Single-blind, randomized, controlled clinical trial with three parallel groups in~     the departments of physical medicine and rehabilitation of two urban hospitals. There were~     127 patients with myofascial pain in the shoulder girdle for more than six weeks in length~     and pain greater than 40 mm on the visual analog scale (VAS). There were three intervention~     groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT +~     LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured~     using the SF36 pain scaleat one and three months.~      Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.~   "
137886|NCT01250171|"~     This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10~     mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition,~     the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab~     were assessed. Blood samples were collected for the analysis of the effect of secukinumab~     and canakinumab on select biomarkers.~   "
137887|NCT01250158|"~     The purpose of this study is to determine whether the PILP-kit can be safely used, within~     specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic~     drug for the treatment of patients with unresectable liver metastases.~   "
137888|NCT01250145|"~     This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized,~     placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy~     postmenopausal women. Part A will examine the cumulative irritation and adherence of the~     transdermal patch, and Part B will examine skin sensitization and adherence. Two separate~     groups of subjects will be enrolled for Part A and Part B of the study. All screening~     procedures will take place up to 28 days prior to enrollment.~   "
137920|NCT01249716|"~     To assess the effect on geriatric patients of follow-up home visit including nutrition.~      The hypothesis is that this can prevent hospital readmissions, and has a positive impact on~     functional abilities and quality of life~   "
137889|NCT01250132|"~     Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of~     100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in~     adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most~     common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic~     (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits~     (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of~     view, the lesional mechanism responsible for hypopituitarisms would be a damage of~     hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits~     and the potential beneficial effects of replacement therapy on quality of life, tiredness,~     loss of energy and productivity, justify the systematic detection of the deficits in~     patients with moderate to severe TBI.~      Study hypotheses :~      At the present time, the lack of data in children does not give us the opportunity to affirm~     that one part of the symptoms showed by children with post-TBI neuropsychological sequelae,~     are linked to pituitary deficiency and that they can be improved with a replacement therapy.~      Firstly, it is essential to better understand the natural history of post-TBI pituitary~     deficiencies, studying the connexion between observed deficiencies in acute and late phase~     of sequelae.~   "
137890|NCT01250119|"~     This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations~     in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer~     (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm~     study to evaluate progression-free survival and quality of life with first-line Tarceva~     (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily.~     Anticipated time on study treatment is until progressive disease or unacceptable toxicity~     occurs. Patients with negative EGFR mutation results will be offered treatment as per the~     centre's standard of care.~   "
137891|NCT01250106|"~     The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota~     improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2~     diabetes patients by improving gut hormone secretion and compare these findings to healthy~     lean subjects.~   "
137892|NCT01250093|"~     In order to investigate the therapeutic effect of acupuncture on chronic neck myofacial pain~     syndrome, the investigaotrs designed a pilot study of a single-blind randomized controlled~     trial. A total of 34 chronic neck myofacial pain syndrome patients were selected from~     Department of Neurology of Nantou Hospital, Department of Health. The age ranged from 18 to~     85, and all subjects were full informed consent and volunteers. They were divided into two~     groups of 17 subjects randomly as follows: acupuncture group, acupuncture stainless needles~     were inserted into bilateral Fenhchi, Jianliao and Houxi acupoints, respectively. The~     acupuncture needles then were manual twist and de Qi, and remain for 20 min; sham~     acupuncture group, the methods were identical the acupuncture group, but acupuncture~     stainless needles were inserted into subcutaneous tissue only. All the subjects were treated~     with acupuncture two times per week and continuously three weeks, i.e. Six times acupuncture~     treatment. The therapeutic effect of acupuncture was assessed before and finishing six times~     acupuncture treatment, and four weeks and twelve weeks after stopping acupuncture,~     respectively. The index of acupuncture therapeutic effect was according to the range of~     motion (ROM) of the cervical spine, the intensity of pain (Short-Form McGill Pain~     Questionnaire; SF-MPQ) and quality of life (SF-36). The investigators expect acupuncture~     apply to bilateral Fenhchi, Jianliao and Houxi acupoints may relief the pain and motion of~     chronic neck facial pain syndrome patient, and also improves the life quality.~   "
137893|NCT01250080|"~     Glutamine is the most abundant nonessential amino acid in the human body. Besides its role~     as a constituent of proteins and its importance in amino acid transamination, glutamine may~     modulate immune cells.~      The innate immune system is the first line of host defence against pathogens and in most~     cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR)~     comprise a family of germ line-encoded trans-membrane receptors which activation leads to~     the induction of inflammatory responses, phagocytosis but also to the development of antigen~     specific adapative immunity.~      It has been postulated though not formally proven yet that glutamine beneficial effect could~     be due to a positive effect on the innate immune system. Given the importance of TLRs and~     TLRs-dependent signalling in host defence against infections we hypothesized that glutamine~     may increase the expression and/or functionality of TLRs which in turn may have beneficial~     effects to clear infections.~   "
137894|NCT01250067|"~     In this proposal, in addition to the conventional MRCP recording, the dipoles and sources of~     the different subcomponents of MRCP will also be analyzed with the brain electric source~     analysis (BESA) to evaluate the difference in the solutions and source strength underlying~     the MRCP between normal controls and patients with ET.~   "
137895|NCT01250054|"~     The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.~   "
137896|NCT01250041|"~     Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this~     study we compare two techniques for pain control after total knee arthroplasty in terms of~     preserving the motor function (the strength of the quadriceps muscles of the thigh) which~     will facilitate the rehabilitation and accelerate the hospital discharge. We will use~     ultrasound guided technique to block either the femoral nerve in the control group or the~     saphenous nerve in the experimental group. The primary outcome is the functional capacity~     and the impact of each block on the ability to walk by measuring the distance patients are~     able to walk in two minutes in post operative day one in the two groups. The secondary~     outcome is the morphine consumption in the two groups.~   "
137897|NCT01250015|"~     To establish whether provision of numerical data, framed as event rates and illustrated by~     pictograms, and including figures for all-cause mortality, affects subjects' attitudes to~     colorectal cancer (CRC) screening.~      Design and Intervention. Randomised questionnaire and telephone study comparing the~     responses of a control group given the standard National Health Service (NHS) CRC screening~     information with the responses of an intervention group given the same information but~     enhanced with additional numerical and pictorial information.~      Setting~   "
137921|NCT01249703|"~     1. Find the early diagnostic markers of erectile dysfunction;~        2. Study the warning role of ED in some diseases.~   "
137922|NCT01249690|"~     The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen~     in newly diagnosed multiple myeloma(MM).~   "
137898|NCT01250002|"~     Although ambulatory gynecological laparoscopy is considered to be a minimally invasive~     surgical procedure, only 60% of patients undergoing this procedure are satisfied with~     postoperative pain control. Postoperative pain can lead to physiological, immunological and~     psychological derangements in patients.It also has been shown to be the most common cause of~     hospital admission after outpatient surgery.~      Opioids constitute the most commonly used pain management strategy after surgery, however~     they have many undesirable side effects including nausea, vomiting and respiratory~     depression. Different strategies have been developed to decrease the amount of opioid~     required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown~     to be effective. Systemic administration of lidocaine has been shown to decrease opioid~     consumption, improve recovery of bowel function and promote a better recovery after~     inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and~     anti-inflammatory properties. It also has an excellent safety profile when give by a~     low-dose infusion.~      The improvement of surgical technique and anesthesia care has made major adverse outcomes~     infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery~     has become an important outcome in several studies. The patient's capacity to return to his~     normal activities is one of the most important sign of a successful outpatient procedure and~     it has significant economic implications.~      Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of~     post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful~     outcome measure to assess the impact on changes in health care delivery, but anesthesia~     studies underutilize this instrument.~      The research question for the study is; does the use of systemic perioperative lidocaine~     improve quality of recovery after outpatient laparoscopy?~   "
137899|NCT01249989|"~     The average adult has a poor quality diet and sedentary lifestyle, but the best way to~     produce sustained healthy change remains unknown. The MBC2 intervention uses handheld~     technology to help individuals monitor and transmit information about their eating and~     activity remotely to a behavior coach. The proposed trial tests whether MBC2 intervention~     improves diet and activity more than a stress management control condition, and whether~     changing multiple health behaviors is best achieved by changing them all at the same time,~     or one after another.~   "
137900|NCT01249976|"~     Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a~     bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing~     diagnostic methods have been recently developed. The aim of the study is to evaluate three~     catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the~     differential time to positivity between a blood culture drawn from a peripherical vein and~     another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and~     stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of~     the area around the insertion site of the CVC.~   "
137901|NCT01249963|"~     The aim of the study is to evaluate the beneficial effects of the administration of enteral~     nutrition product with milk proteins, monounsaturated fatty acids and low dextrose~     equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid~     (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All~     this against other specific product.~      The main objectives of this project are:~        -  Comparing the tolerance of both preparations.~        -  Comparing the evolution of nutritional status in both groups.~        -  Comparing the evolution of inflammatory parameters in both groups~   "
137902|NCT01249950|"~     single-center study carried out in order to evaluate in prospective among patients seen or~     treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the~     potential number of patients eligible for surgery.~   "
137903|NCT01249937|"~     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of~     blindness. This disease was once thought to be a natural part of aging, but recent research~     has introduced effective treatments. ARMD is related to the body initiating an immune~     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue~     becomes inflamed and new blood vessels form at the back of the eye, a process called~     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels~     and impair the eye's structure and function. Many studies have shown that ranibizumab, a~     drug that stops the formation of new blood vessels (an anti-angiogenic agent) can delay~     damage to the eye and often restore vision. The investigators believe the best drug therapy~     will also stop the inflammation. Triamcinolone acetonide, a steroid drug, has shown the~     potential to effectively reduce inflammation in this application. The investigators aim to~     investigate if patients receiving a combination treatment of ranibizumab and triamcinolone~     acetonide improve their visual abilities more than those receiving just ranibizumab~     treatment alone. Secondarily, the investigators will also investigate how often patients~     receiving each drug therapy regime require re-treatment and how often they experience~     further vision loss.~   "
137904|NCT01249924|"~     Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent~     postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients~     with moderate and severe OSA.~   "
137905|NCT01249911|"~     Randomized, doble blind, clinical, controlled trial aimed to investigate the role of~     Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract~     infections in mexican children who attend day care centers.~      Primary Outcome: The primary outcome will be days with diarrhoea. Secondary Outcomes: a)~     Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c)~     Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct~     and Indirect costs.~      Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260~     healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be~     recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108~     colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks,~     follow up for other additionally 12 weeks of observation. Days with respiratory tract~     infections (RTI); days of absences from day care centre; days of antibiotic use; days of~     medical office visits or emergency visits; and direct and Indirect costs will be compare~     between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness~     analysis~   "
137906|NCT01249898|"~     Scaphoid fractures are the most common carpal bone fractures, and second most common wrist~     fractures (second to distal radius fractures). Lack of proper immobilization or displacement~     of these fractures commonly results in fracture nonunion or malunion followed by the~     development of wrist post-traumatic osteoarthritis. In addition, proper reduction and~     fixation of these fractures are challenging to the most experienced hand surgeons.~      The investigators are going to follow-up the patients population suffering from Scaphoid~     fractures(nonunion included) for one year. The investigators will evaluate this follow up~     results in two ways:~        1. Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.~        2. Treatment of scaphoid fracture non-union.~   "
137909|NCT01249859|"~     Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the~     upper digestive tract in western countries~        -  Discordant results in the literature concerning the prognosis value of the presence of~          signet ring cells.~        -  Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often~          in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more~          frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo~          resistance (vi) the need for a specific therapeutic strategy compared to non-signet~          ring cell adenocarcinomas.~      Primary objective To test the hypothesis that 5-year survival rate is significantly lower in~     the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the~     upper digestive tract~      Secondary objectives~        -  Impact of neoadjuvant CT on overall survival~        -  Impact and differential diagnostic value of linitis~        -  R0 resection rates~        -  3 years recurrence free survival~        -  Overall 3 years survival~        -  Prognostic factors~        -  Prognostic value of the presence of a minority quota of signet ring cell~        -  Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in~          non-resected patients~        -  Tolerance of (radio) chemotherapy for ADCI~      Methodology Intention to treat retrospective case-control multicentric study A pairing on~     demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be~     done to ensure comparability in case control study groups.~      Inclusion criteria All consecutive patients taken care of, for a proven histologically~     adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach,~     in surgical or medical oncology investigator centers, will be saved in a given database.~      For whom the first consultation took place between January 1997 and January 2010~      Exclusion criteria Histological type other than adenocarcinoma Other localization than~     esogastric junction, esophagus or stomach~      Planned study period The data will be collected over a period from January 1997 to January~     2010.~      The objective is to complete the data collection for summer 2010.~   "
137910|NCT01249846|"~     The purpose of this study is to assess the efficacy and the safety of Chlorhexidine~     Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of~     adult chronic periodontitis.~   "
137911|NCT01249833|"~     This study has been designed to determine if subjects treated with oseltamivir in addition~     to standard of care treatment for influenza demonstrate a greater improvement in attention /~     working memory / processing speed / mood as compared to subjects receiving standard of care~     alone. The cognitive tests employed are objective measures developed and administered online~     by HeadMinder Inc.~   "
137912|NCT01249820|"~     The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given~     intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem~     cell transplant following myeloablative chemotherapy or patients receiving intensive~     chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.~   "
137913|NCT01249807|"~     Cancer Screening is necessary for promoting cancer prevention in the area of public health.~     The Department of Health, Executive Yuan of the Republic of China has expanded and included~     colon cancer screening, oral cavity cancer screening, breast cancer screening, and cervical~     cancer screening in national-wide preventive healthcare services. However, most of the~     Taiwanese do not have the concepts of what cancer screening is and regular participation of~     cancer screening. This will easily cause their neglect of quality of personal healthcare and~     habits of cancer screening. Recently, in order to reach the national goal of cancer~     prevention, the parallel methods, multi-promotion for reinforcing concepts and free cancer~     screening, have been utilized to cultivate Taiwanese people's active participation of cancer~     screening. Therefore, this study will use health service utilization model to investigate~     Taiwanese people's concepts of cancer-related knowledge and the major causes of low~     participation of cancer screening.~      In order to investigate Taiwanese people's health service utilization model and quality of~     health life, this study first review the related regulations and screening rates of cancer~     prevention, including cancers of colon, oral cavity, breast, and cervical, in Taiwan. In~     addition, the structured questionnaire will be conducted to collect, investigate, and~     analyze the relationship between the willingness of participating the aforementioned cancer~     screening and personal characteristics, quality of health life, medical history, and~     concepts of cancer, etc. It is expected that the results of this study will provide accurate~     and effective promotions of cancer screening to medical institutions and medical affairs to~     reinforce the concepts of participation for raising the rates of cancer screening;~     furthermore, to awaken Taiwanese people's crucial awareness of early treatment improves the~     chances of recovery on cancer.~   "
137914|NCT01249794|"~     Patients with respiratory failure following cardiac surgery are randomized to receive~     standard therapy versus non invasive ventilation. The hypothesis is that patients receiving~     non invasive ventilation will perform better than those who received standard therapy.~   "
137915|NCT01249781|"~     The purpose of this study was to explore caregivers stress, family functioning, social~     support and family resilience of families whose children had acute lymphoblastic leukemia.~     The significantly correlation among caregivers stress, family functioning, social support~     and family resilience was also explored.~   "
137916|NCT01249768|"~     Background:~      Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy,~     Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease~     entities with partly common symptomatology. Especially very early in the course of disease,~     the differentiation between both disease entities can be challenging, even for specialists~     in the field of movement disorder. However, the establishment of a correct diagnosis is very~     important for adequate patientcounseling, treatment and the correct inclusion of patients in~     research trials. Ancillary diagnostic investigations are looked upon to aid in this~     diagnostic dilemma.~      Objective:~      To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis~     of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to~     differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.~   "
137917|NCT01249755|"~     Recently our ICU research group developed and validated a delirium prediction model in the~     NetherlandsThis. This model has a high predictive value. We want to examine what the~     predictive value is in ICUs of other European countries.~   "
137918|NCT01249742|"~     Background~      The treatment of diabetes is multidisciplinary. Alignment of care of the various~     professional disciplines is, however, not always optimal. This can lead to confusion about~     treatment interventions and behavioral advices. In adolescence, good fine-tuned care is of~     extreme importance because of the difficulties in regulation of the disease in this phase of~     life (Snoek, 2004). These difficulties are due to biological changes but also to~     socio-psychological developmental changes. The adolescents' psychological development~     demands more autonomy and responsibility for the diabetes (care) by the adolescent. The~     social development can conflict with the treatment regime, because of the adolescents'~     social needs (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess~     whether an interactive website, on which adolescents with diabetes and their treatment team~     can communicate, leads to better alignment of care and better control over the disease.~      Intervention~      The diabetes has great impact on the adolescents' everyday life. Finding a balance between~     more autonomy, participating in social life with (healthy) peers and control of the disease~     is difficult and seems to act as a thread during this phase in life.~      This can lead to questions and uncertainty at any given moment. The interactive website~     provides the adolescent access to information and to his or her individual treatment plan~     and advices fitted to his or her condition and life. The adolescent can pose questions at~     any given moment through the online forum and their personal treatment page. Since the~     treatment team answers the question within a day, fit between diabetes care and adolescents'~     everyday life is optimized.~      Research question~      Does an online interactive treatment environment, on which adolescents with diabetes can~     communicate with their treatment team, lead to better fit of care and to better disease~     control?~   "
137919|NCT01249729|"~     We use the three-dimensional image software reconstruct MRI. The propose of this research~     purposes as follows: 1. 3D reconstructed image processing from MRI to realize the short term~     nervous system response after dynamic acupuncture stimulation.2. Realizing the corresponding~     area in the brain caused by electroacupuncture. 3. Realizing the connection between~     electroacupuncture stimulation and brain physics, chemistry, and physiology. The implement~     the two-dimentional image into three-dimensional image by Amira software, in order to find~     out the difference of the pre-and post- response of the nervous system. In addition, we will~     use describe statistics and Paired t-test statistical analysis, compare the statistical~     difference of blood oxygen concentration.~   "
137924|NCT01249664|"~     VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to~     choroidal neovascularization secondary to pathologic myopia. This will be a~     placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye~     into the affected eye (and repeated injections if required), and 1 out of 4 patients will~     receive a sham injection requiring no needle stick, but making the patient unaware of~     whether or not he received active treatment.~      Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham~     patients may receive active treatment.~      Total duration of the study will be 48 weeks.~   "
137925|NCT01249651|"~     Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving~     rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant~     improvement of heartburn after 8-week treatment.~   "
137926|NCT01249638|"~     Patient with multiple metastases, not eligible for surgery, might not profit from intensive~     chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease~     control may be a better choice for first line treatment. Therefore this study investigates~     the combination of capecitabine and bevacizumab versus the combination of capecitabine,~     bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated~     with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is~     time-of-failure strategy (TFS) comparing both treatment arms.~   "
137927|NCT01249625|"~     Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace,~     there is very little clinical evidence that respirators prevent healthcare personnel (HCP)~     from airborne infectious diseases. Scientific investigation of this issue has been quite~     complicated, primarily because the use of respirators has become the standard of care for~     protection against airborne diseases in some instances, even without sufficient evidence to~     support their use. The key question remains: How well do respirators prevent airborne~     infectious diseases? The answer to this important question has important medical, public~     health, political and economic implications.~   "
137928|NCT01249612|"~     With this study the investigators wish to (1) investigate the acute effect of knee joint~     icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2)~     investigate the acute effect of knee joint icing on knee pain, knee joint circumference and~     functional performance shortly after TKA.~   "
137929|NCT01249599|"~     The aim of this prospective single-center study is to evaluate endothelial function,~     arterial compliance, sympathetic nervous activity at rest and after mental and physical~     stress, carotid atherosclerosis, oxidative stress parameters, quality of life and platelet~     adhesion in patients with apical ballooning syndrome and age-matched controls.~   "
137930|NCT01249586|"~     E-learning material increases the student knowledge level before the traditional class of~     blindness prevention and help to fix this information a short period (one month) after the~     class.~   "
137931|NCT01249573|"~     This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis~     in the treatment of an acute ankle sprain. These treatments will be compared to a placebo~     group.~   "
137932|NCT01249560|"~     The objective of the antiretroviral treatment is to inhibit the viral replication,~     estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this~     inhibition of the viral replication usually joins an immune reconstruction [ 1 ].~     Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral~     load(responsibility) and an absence of immune reconstruction, is regularly observed. It is~     now turned out that an undetectable viral load(responsibility) does not correspond to the~     total absence of viral replication and that it is possible to detect of the intracellular~     pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the~     integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could~     decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so~     optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest~     that the regression of the abnormalities of cellular interactions, and the rate of apoptose~     abnormally raised(abnormally brought up) by cells(units) T at the patients in~     viro-immunological dissociation, could be obtained .~      This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte~     and monocyte, to quantify the expression of the molecules of costimulation, the~     source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the~     rate of apoptose of the cells(units) T.~   "
137933|NCT01249547|"~     This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety~     of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one~     line of platinum based chemotherapy.~   "
137934|NCT01249534|"~     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive~     protein (CRP) in the postoperative course. The aim of this study was to evaluate the~     diagnostic accuracy of CRP for postoperative inflammatory complications after~     gastroesophageal cancer.~   "
137935|NCT01249521|"~     This is a clinical trial investigating the effectiveness and safety of the combination of~     the study drugs bevacizumab and AMG386 in patients with advanced (metastatic)~     chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in~     metastatic bowel cancer in terms of maintenance of quality of life and extension of~     survival. However, ultimately tumours will develop resistance to these agents and further~     treatment options are urgently required.~      Angiogenesis is a process that results in the formation of new blood vessels. Similar to~     normal tissues, solid tumours require new blood vessels for growth and survival. Hence,~     drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.~      AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is~     evidence from laboratory and animal studies to suggest that such a combination could be~     useful as a cancer treatment. Previous studies in humans have shown that AMG386 and~     bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and~     safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.~      40 patients from approximately four hospitals in Australia will participate in this trial,~     with approximately 20 patients being enrolled at Austin Health. All participants will~     receive the same treatment.~   "
137936|NCT01249508|"~     This study aims to evaluate a nutrition labelling program in improving university canteen~     customers' dietary pattern and behavioural determinants (e.g. knowledge).~   "
137938|NCT01249482|"~     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of~     proton-pump inhibitor has been reported in previous studies. In patients with concurrent~     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of~     Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of~     proton-pump inhibitor remains elusive Objective: This study aims to investigate the~     incidence and severity of acid-related symptoms after discontinuation of proton-pump~     inhibitor in reflux patients receiving H. pylori eradication.~   "
137939|NCT01249469|"~     Background: Solar lentigines are a common dermatologic condition that manifest as~     circumscribed single or multiple brownish macules usually located on sun-exposed skin such~     as face, hands or forearms. An effective, safe, daily-use, homecare whitening product may~     alleviate the cosmetic concerns for the general population. The efficacy and safety of the~     previous generation BEX-2009 (Blanc Expert Spot Eraser, L'Oreal, France), a whitening~     cosmetic product containing ellagic acid, salicylic acid, licorice root extract, etc., has~     been established in Caucasian and Asian populations with facial solar lentigines.~      Objective: The purpose of this placebo-controlled, single-center study is 1) to evaluate the~     efficacy of the new generation whitening cosmetic product BEX-2011 (Ultimate Whitening Spot~     Eraser, L'Oreal, France) in the improvement of solar lentigines on the dorsum of hands or~     forearms, and 2) to evaluate the efficacy of BEX-2011 by harmonic generation microscopy to~     obtain information of the epidermal melanin continuum, compared to other standard tools for~     melanin measurement.~   "
137940|NCT01249456|"~     Title of study: An observational, multicenter study on the safety and efficacy of Femara®~     (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed~     adjuvant Tamoxifen or Toremifen treatment~      Objectives:~      The major objective of the study is to assess safety and efficacy of Femara® in women who~     had undergone resection of a primary breast cancer and subsequently received prior adjuvant~     tamoxifen or toremifen therapy for 5 years in real-life condition.~      The study aims at the following objectives:~        1. To identify unknown adverse reactions, especially serious adverse reactions~        2. To evaluate incidence and descriptions of adverse reactions under the routine drug use~        3. To identify factors that may affect the safety of Femara®~        4. To identify factors that may affect the efficacy of Femara®~      Methodology: This will be an open-label, multi-center, single-arm, observational phase IV~     study.~      Number of centers & patients: Approximately 610 (planned No. of patients for total study~     period) patients from 4 centers will be enrolled in this study.~      Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment~     with Tamoxifen or Toremifen for 5 years after curative surgery as indications described in~     local product labeling.~      Investigational drug: Femara® will be administered orally as described in dose &~     administration of local product labeling up to 3 years.~      Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3~     years with renewal of contract on yearly basis.~   "
137941|NCT01249443|"~     This phase I clinical trial is studying the side effects and the best dose of vorinostat~     when given together with paclitaxel and carboplatin in treating patients with metastatic or~     recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     vorinostat together with paclitaxel and carboplatin may kill more tumor cells.~   "
137942|NCT01249430|"~     This phase I clinical trial is studying the side effects and best dose of azacitidine when~     given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients~     with relapsed or refractory acute myeloid leukemia. Azacitidine may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as mitoxantrone, etoposide phosphate, and cytarabine, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them~     from dividing. Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work~     better by making cancer cells more sensitive to the drugs.~   "
137943|NCT01249417|"~     The purpose of this research study is to determine whether Dysport® is effective in the~     treatment of increased stiffness of the calf muscles and to evaluate the safety of this~     treatment in children with Cerebral Palsy. In addition this study will also check whether~     Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.~   "
137944|NCT01249404|"~     The purpose of this research study is to assess the efficacy of Dysport compared to placebo~     in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or~     traumatic brain injury.~   "
137945|NCT01249391|"~     Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently~     affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often~     involved causing pain, progressive loss of hand function and deformity. Deviation, or~     bending to the side, of IP joints (IPJs) with significant functional and cosmetic~     consequences for the individual is common. There are no drugs which can slow the disease~     process so there is reliance on symptomatic treatment such as pain relief and hand therapy.~     Joint thermoplastic splinting (moulded plastic splints that are custom-made) is employed by~     hand therapists in other settings, but to the investigators knowledge no studies have~     formally investigated the effect of splinting in IP OA.~      By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting~     in IP OA is likely. In this study, the investigators want to test whether thermoplastic~     splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft~     tissue inflammation, and whether as a consequence 3) pain and overall hand function will be~     improved.~      Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of~     the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially~     this will be for distal IP (DIP) joints. In the intervention group (30 patients), an~     'intervention' joint for splinting will be identified as the most painful deviated DIP joint~     in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand~     will not be splinted but will be monitored as 'control' joints. In the control group (15~     patients), an affected joint will be monitored but not splinted. Assessment of joint pain,~     hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take~     place at baseline, during and at the end of splinting period of 3 months, and also at 6~     months,to assess whether any changes are persistent. In this way, the efficacy of splinting~     of IP joints in OA will be assessed.~   "
137959|NCT01249209|"~     This study is a pilot project to investigate any effect on these markers in conjunction with~     lifestyle changes / conservative treatment. Useful and significant information in this pilot~     project is intended to be used as background for further research on this issue in~     connection with a doctorate.~      What is the effect of two years of outpatient treatment for lifestyle change for weight~     markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults~     with morbid obesity?~   "
137960|NCT01249196|"~     The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients~     with mild to moderate Alzheimer's disease.~   "
137946|NCT01249378|"~     In this study, the investigators are interested in investigating how the emulsification~     state and amount of fat in a meal can modify the kinetics of postprandial lipemia and~     inflammatory outcomes (including endotoxemia) in obese vs lean subjects.~      10 lean and 10 obese volunteers will come 3 times (>3 weeks apart) at the investigation~     center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non~     emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to~     follow the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood~     sampling throughout digestion will allow to measure metabolic, lipid and inflammation~     parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype~     microbiota.~   "
137947|NCT01249365|"~     This extension study is designed to assess the safety of GSK Biological's HPV vaccine~     GSK580299 in female subjects who took part in the primary study NCT00294047 and received the~     control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the~     subject's age group (26 years and older). This study is thus conducted to enable all women~     who received the control placebo in the primary NCT00294047 study to receive the GSK580299~     vaccine.~   "
137948|NCT01249352|"~     The primary objective of this study is to assess the efficacy of nimotuzumab in combination~     with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer,~     comparing it to that of the conventional treatment with radiation and chemotherapy.~      The secondary objective of this study is to assess the health-related quality of life for~     the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the~     standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal~     cancer.~   "
137949|NCT01249339|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
137950|NCT01249326|"~     The main objective of the study is to evaluate the protein requirement associated with~     postoperative weight loss caused by by-pass (shunt which leads to a certain degree of~     malabsorption) or sleeve gastrectomy (more technically conservative with less~     malabsorption), through the study of nitrogen balance. The benefit of protein supply easily~     absorbed and with high essential amino acids content (proteins fast soluble milk) on~     protein metabolism and muscle function will also be studied. Endotoxemia and intestinal~     flora variations were measured before and after bariatric surgery.~   "
137951|NCT01249313|"~     Candidemia is the fourth leading cause of hospital-acquired infection in USA. In CMUH, it~     caused 9% hospital-acquired bloodstream infection in 2008 and 2009. In addition to increased~     mortality, candidemia also increased hospital stay and cost. There is a trend of increased~     cases of candidemia in recent years in CMUH. Early empirical and target treatment can reduce~     mortality and shortened length of hospital stay.~      In the past, most prior studies in Taiwan dealt with risk factors for mortality rather than~     for candidemia and also focused at in vitro susceptibility to antifungal agents. In this~     study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated~     1000 cases. There were some rare Candida species. Therefore, the investigators hope to do~     case study for these diseases to provide the epidemiology of candidemia in CMUH. The result~     can help clinician in predicting the disease and its outcome. Besides, it also provides the~     epidemiology of candidemia in mid-Taiwan.~   "
137952|NCT01249300|"~     Introduction Patients with stroke may be silent aspirators or at risk for laryngeal~     penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk~     for aspiration pneumonia and its serious effects. By providing identification of the~     components of the abnormal swallow, and comparing swallowing across tasks, the investigators~     may avoid aspiration and can instruct patients on preventative or compensatory swallowing~     techniques.~      Materials and methods~        1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing~          function. The patient is interviewed about difficulties with food intake, chewing and~          swallowing during meals.~        2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound~          waves. With the patient in a sitting position, a 3/4-inch transducer (device for~          transmitting and receiving sound waves) is placed under the chin to visualize~          epiglottis movements during swallowing.~        3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of~          flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the~          tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and~          videotaped at the same time epiglottis movement will be trace with ultrasound. The~          barium is given in three consistencies-thin, medium and thick (pudding-like).~      The investigators will study the oral, pharyngeal and upper esophageal phases of swallow~     using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in~     patients with stroke conditions. Most of the previous studies of swallowing have utilized~     diagnostic imaging technique to provide a complete swallowing assessment, but limited~     capabilities for screening large population of patients.~      INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected~     dysphagia can be included for study as well as patients who are admitted specifically for~     this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or~     choking when eating, shortness of breath during swallowing, food backing up into the mouth~     or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained~     loss of weight.~      EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be~     excluded if they do not have sufficient cognitive ability to follow directions.~     Non-ambulatory patients will be excluded if they cannot be braced or supported within the~     fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to~     remain confined in the equipment.~      Analytic Methods The Student t test will be used to analyze the difference in epiglottis~     movements during swallowing amongst different phases. Levene's test for equality of~     variances will be applied to examine the variability of epiglottis movements during~     swallowing between the groups. All statistical analysis will be performed with SPSS.~   "
137953|NCT01249287|"~     A growing number of studies highlight the potential of stem cell transplantation as a novel~     therapeutic approach for stroke in animal model. But the stem cell therapy for chronic~     stroke patients has not been well investigated yet. In this study, the investigators will~     test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+)~     (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination~     of corticospinal tract in the lesion side, focal increased perfusion and increased cortical~     activity in the peri-infarcted area will be monitored by the functional MRI after stem cell~     therapy. The investigators study is aimed to find the potential mechanisms of the functional~     recovery after stem cell implantation. The investigators also hope to find image surrogate~     markers for prediction of patient outcome. The possible surrogate markers will be helpful in~     improving the treatment procedure and patient selection.~   "
137954|NCT01249274|"~     The investigators propose a placebo-controlled, randomized clinical trial that would enroll~     50 postpartum women with a history of cocaine abuse or dependence to assess whether~     progesterone (100mgs twice daily) decreases postpartum cocaine use.~   "
137955|NCT01249261|"~     The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on~     BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.~   "
137956|NCT01249248|"~     This is a double blind observational analysis of changes in heart rate variability using~     PD2i analyser in competitive athletes during strenuous exercise and competition.~   "
137957|NCT01249235|"~     The purpose of this study is to determine if patching the eye or a bandage contact lens~     along with Tylenol #3 is more effective for pain control following pterygium surgery.~   "
137958|NCT01249222|"~     Sepsis is one of the most prevalent and fatal diseases in intensive care units~     .unfortunately, therapeutic approach to sepsis has remained unchanged for many years.~     Nowadays, the role of cytokines in pathogenesis of sepsis is obvious. Continuous elevated~     levels of various cytokines in severe sepsis could result in uncontrolled inflammation~     status. Breaking of inflammatory cascade may lead to improvement in survival. It seems that~     modulation of inflammation is one of the strategic plans to conquest sepsis. Therefore,~     elimination of bacterial toxins and pro-inflammatory cytokines from the systemic circulation~     by plasmapheresis supposed to be rational approach.~      Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis~     treatment. However because of inconsistent results, routine use of this procedure in~     patients with severe sepsis remains controversial.~      The aim of the present survey is to determine the effect of plasmapheresis on plasma levels~     of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of~     outcome and treatment of severe sepsis.~   "
137961|NCT01249183|"~     Primary objectives:~      To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of~     age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.~      Secondary objectives:~      •Secondary immunogenicity objectives: To describe the immune responses 28 days after~     concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age~     and older To describe the immune response of VAXIGRIP according to European Medicines Agency~     criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)~      •Secondary safety objective: To describe the safety profile after vaccination in each group~   "
137962|NCT01249170|"~     Study to determine if pulmonary/critical care fellows will demonstrate increased competency~     in the behavioral skills necessary to facilitate family meetings focused on discussions of~     goals of care in the ICU from pre- to post-communication skills training.~   "
137963|NCT01249157|"~     Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast~     that uses a radioactive glucose based tracer, which is a form of sugar attached to a low~     radiation agent, to detect cancer cells. The radioactive glucose based tracer is called~     fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect~     cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA~     approved. This type of imaging may be able to see the breast cancer before it could be seen~     with mammograms and may be as good as or better than breast MRI.~      The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM)~     with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with~     breast cancer. This study will also perform special pathology test to compare the FDG PEM~     and contrast enhanced breast MRI images with the results from the standard of care breast~     surgery. This may teach us more about the biology of each breast tumor.~   "
137964|NCT01249144|"~     This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to~     replace the natural crystalline lens after cataract extraction. The variables compared~     include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity~     outcomes three months after implantation.~   "
137965|NCT01249131|"~     This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy~     participants for determining the relative bioavailability of the tablet formulation to the~     capsule formulation and the effect of food on the relative bioavailability of the tablet~     formulation.~   "
137966|NCT01249118|"~     The primary objective of Part 1 of this study is to evaluate the safety and tolerability of~     the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to~     evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK)~     of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this~     study is to evaluate the safety of GDC-0973 administered orally and intravenously.~   "
137967|NCT01249105|"~     MK-2206 is a newly discovered drug that may slow or stop cancer growth. This drug has been~     used in other research studies, and information from those other research studies suggests~     that MK-2206 may help to slow or stop the growth of malignant gliomas. In addition, MK-2206~     has the capacity to cross the blood-brain barrier. The blood-brain barrier (BBB) is a~     separation of circulating blood and cerebrospinal fluid (CSF) in the central nervous system~     (CNS); and although it serves as a protective barrier, it can often interfere with~     potentially beneficial treatments reaching the brain successfully. Therefore, the~     investigators hope that because MK-2206 can successfully cross the blood-brain barrier, it~     will be more effective in patients. The purpose of this study is to see how well MK-2206~     works in patients with malignant gliomas and will be conducted in two parts: Part 1 and Part~     2.~      Part 1 of the study will investigate the effects of MK-2206 on Akt signaling in tumor~     tissue. Ten patients with recurrent GBM who require reoperation will receive a short~     pre-operative course of MK-2206. After recovery from surgery, patients will resume MK-2206~     until disease progression or the development of unacceptable toxicities. Part 2 of this~     trial will be initiated only AFTER analysis of Part 1 data shows drug penetration into tumor~     tissue; if there is no significant drug penetration into the tumor and/or there is no~     reduction of pAkt levels, progression to Part 2 of the trial will be halted. The primary~     goal of Part 2 is to determine the therapeutic efficacy of MK-2206 as measured by 6-month~     progression-free survival (PFS6). In Part 2, 40 participants with GBM and 18 with anaplastic~     glioma will be treated with MK-2206 weekly at a dose selected on the basis of an ongoing~     phase 1 study. Treatment duration will be measured in 4-week cycles. Participants will~     remain on treatment until tumor progression, as long as there are no unacceptable~     toxicities. Responses will be assessed by clinical examinations every 4 weeks and MRI scans~     every 8 weeks.~   "
137968|NCT01249092|"~     Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive~     destruction of small bile ducts within the liver that can lead to end stage liver disease~     and all its complications.~      Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients~     with PBC, there is absence of an adequate response to UDCA in a significant proportion of~     PBC patients.~      Tumor necrosis factor alpha (TNF-alpha) is a cytokine that plays an important role in the~     pathogenesis of PBC. Other fibrosis biomarkers such as tissue metallo proteinase 1 (TIMP-1)~     are associated with progression of liver fibrosis in PBC. Pentoxifylline (PTX) is a~     methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown~     anti-fibrotic effects in serum of patients with PBC. Furthermore, PTX has well known~     clinical and safety profiles. The main hypothesis of this study is that therapy with~     pentoxifylline (PTX) will result in improvement of liver disease in PBC patients who are~     incomplete responders to UDCA.~      The focus of this proposal is on the effectiveness of PTX in improving laboratory parameters~     of liver disease and levels of cytokines involved in the pathogenesis of the disease in~     patients with PBC.~   "
137969|NCT01249079|"~     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications~     that propose to enrich pre-existing resources for schizophrenia in the National Institute of~     Mental Health (NIMH) Human Genetics Initiative and to apply genomic methods to further the~     investigators understanding of the molecular etiology of the disorder. The overarching aims~     of this proposal are to quickly and cost-effectively ascertain a large sample of trio~     families affected by schizophrenia, and to discover causal variants for the disorder in the~     first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is~     no such kind of policy to support this kind of GWAS study as it is a very expensive study,~     including collecting large family samples and genome-wide single-nucleotide polymorphism~     (SNP) scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his~     entended subcontracted researchers to apply for this project. The investigators, the~     research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia.~     Through additional ascertainment within this framework, the investigators will collect an~     aggregate sample with adequate power for detecting in a GWAS those variants that make even~     small contributions to the risk for the disorder.~      The investigators will meet the overarching goals of this project by accomplishing several~     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese~     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending~     all clinical data and biomaterials to the appropriate repositories; 3) Assess the~     association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms~     (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes~     such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to~     schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for~     gene-environment interactions, such as the well-established effect of season of birth.~   "
137971|NCT01249053|"~     Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner~     mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is~     associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial~     bioenergetics and mitochondrial networks. The changes in mitochondrial shape and~     mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the~     expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.~   "
137972|NCT01249040|"~     The purpose of this study is to investigate and compare different treatment programs for~     frozen shoulder by evaluating changes in pain scale and shoulder range of motion(ROM) before~     and after treatment.~      The investigators define frozen shoulder as shoulder pain with ROM limitation,shoulder~     arthrography demonstration of at least two of the following criteria:(1)reduced joint volume~     under 10ml; (2)irregular capsular margin;(3)diminished or absent axillary recess.~      Afer define diagnosis of frozen shoulder ,patients are randomly assigned to different~     Subgroups for different treatment programs.Each subgroup consists of ten patients.~      Each treatment program performed for 6 consecutive courses with each course consists of 6~     days.Total 36 treatment days.~      The treatment programs and grouping as follow:~      Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic~     exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise Before~     treatment,after each consecutive course (6days) of treatment,and at the end of treatment~     program, the investigators evaluate the range of motion and muscle strength of shoulder~     flexion,external rotation,abduction and internal rotation. Severity of shoulder pain also~     evaluated by pain scale before and after treatment program.~      The ROM before and after treatment program is compared by paired t-test.The ROM change~     before and after treatment in different groups compared by analysis of variance(ANOVA). The~     ROM change after consecutive treatment courses(6 days) are compared by multivariate~     ANOVA.Pain scale before and after treatment is compared by paired t-test.~   "
137973|NCT01249027|"~     This is a prospective, observational, single-arm, open-label, multicenter, postapproval~     registry study in China. The purpose of this study is to:~        -  Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of~          real-world patients receiving the XIENCE V EECSS during commercial use~        -  Evaluate patient compliance to dual antiplatelet therapy (DAPT)~   "
137974|NCT01249014|"~     During surgery body temperature can decrease which can adversely affect how people recover~     from surgery. This is a common problem. We aim to reduce the incidence of this drop in body~     temperature during surgery by testing the effectiveness of two active body warming devices.~     One method is to warm the intravenous fluids that the patients will receive, as they are~     being infused. The other method is to use a forced-air warmer. This is a device that is~     similar to a blanket that the patient has laid over their upper body during the surgery~     which has warm air blown into it. The control group will not have any active warming~     methods. Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative~     period.~      Study group 2 will have a forced-air warmer in the intra-operative period as well as the~     fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital~     signs following delivery.~   "
137975|NCT01249001|"~     The primary objective of this study is to compare the absorption of a prepared aprepitant~     oral suspension with that of the aprepitant capsule in children being treated with~     chemotherapy agents that are likely to cause vomiting.~   "
137976|NCT01248988|"~     The purpose of this study is to collect safety information following routine vaccination~     with Synflorix™ among infants in Korea.~   "
137977|NCT01248975|"~     The primary objective of this study is to evaluate the efficacy and safety of adding~     GSK2190915 300mg or placebo tablets administered once daily to fluticasone~     propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled~     asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.~      The secondary objectives are to undertake an exploratory analysis of the efficacy and safety~     of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol~     250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics~     and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age~     over the course of 6 weeks treatment.~   "
137978|NCT01248962|"~     Patients who have this kind of cancer are often treated with several drugs. Carboplatin is~     one that seems to work for many treatment cycles. Even though it may work against the~     cancer, the patient can become allergic to it. If that happens, they would have to stop~     taking the drug. The standard way to give carboplatin is by vein over 30 minutes. The~     purpose of this study is to:~      Find out if giving carboplatin over three hours can prevent the allergy. See if medicine~     given before the carboplatin can help reduce the risk of allergic reactions.~      Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer~     allergies than we expected. We do not know if this was because of the way they got~     carboplatin or because of something else.~   "
137979|NCT01248949|"~     To determine the maximum tolerated dose or optimal biological dose, and the safety profile~     of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic~     agents in subjects with advanced solid malignancies resistant to standard therapy.~   "
137980|NCT01248936|"~     This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in~     patients who have received prior systemic therapy for metastatic melanoma and who have no~     other satisfactory treatment options.~   "
137981|NCT01248923|"~     This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma~     (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and~     bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor~     (G-CSF) support.~      This study has 2 parts. In the first part, patients will receive increasing doses of study~     drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF~     support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the~     highest dose of study drug possible that will not cause unacceptable side effects.~     Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).~      In the second part of this study, patients will receive the best dose(s) and schedule(s) of~     study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the~     first part of the study and will be followed to see what side effects the combination causes~     and what effectiveness the combination has, if any, in treating the cancer. Approximately 42~     patients from the US will be enrolled in Part 2 (Active, not recruiting).~   "
137982|NCT01248910|"~     Older people tend to live a sedentary lifestyle which causes a loss of cardiorespiratory~     fitness, impaired postural stability and a increased risk of falls. Social isolation of~     older people leads to depression and other mental diseases. However, numerous studies show~     that age-related degradation processes and functional limitations can be counteracted by~     physical activity. Various studies show that alpine skiing is a complex sport that places~     demands on the cardiorespiratory, neuromuscular and sensorimotor systems. With studies~     providing evidence to suggest alpine skiing is an appropriate activity for elderly as a~     health-enhancing sport, perhaps Alpine skiing could provide the physical activity needed to~     counteract age-related degradation processes and loss of function. To date, there is a lack~     of long-term intervention studies devoted to this topic. The aim of this study was to~     monitor the long-term effects of skiing on the health of older people, as to age-related~     muscle breakdown, cardiorespiratory fitness, body stability, general mobility and the~     overall psychological state of the subjects.~   "
137983|NCT01248897|"~     The purpose of this study is to understand how information of 3 specific biomarkers can~     provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.~   "
137984|NCT01248884|"~     This study is designed to evaluate the safety and immunogenicity of new formulations of GSK~     Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination~     course to healthy infants at 2, 3 and 4 months of age.~   "
137985|NCT01248871|"~     To compare the renal protective properties of two currently used anaesthetic techniques - a~     sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil~     combination for anaesthesia in patients undergoing living donor kidney~     donation/transplantation.~   "
137986|NCT01248858|"~     This is a Phase I, open-label, dose-escalation study to characterize the safety,~     tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the~     oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in~     subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose~     escalation phase and a tumor specific cohort expansion.~   "
137987|NCT01248845|"~     Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory~     pattern of various level of assistance delivered by the ventilator in intubated~     spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted~     Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow,~     airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.~   "
137988|NCT01248832|"~     The study tested the effects of telephone counseling for smokers from three Asian language~     speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the~     efficacy of a culturally appropriate counseling protocol for smokers calling the California~     Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether~     intervention effects varied by cognitive and behavioral predictors of cessation success, 4)~     examine whether family involvement plays a role in quitting success, and 5) assess~     differences in counseling effect across the three ethnic groups.~   "
137989|NCT01248819|"~     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after~     laparoscopic procedures have provided conflicting results. This randomized, double-blind~     study was designed to assess the effects of a novel intraperitoneal local anesthetic~     administration technique using nebulization on pain relief after laparoscopic~     cholecystectomy.~   "
137990|NCT01248806|"~     The purpose of this study is to offer annual low-dose spiral CT radiological examination for~     5 years to 5000 volunteers from the general population who are considered to be at high risk~     of developing lung cancer.~   "
137991|NCT01248793|"~     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese~     patients with ankylosing spondylitis~   "
137992|NCT01248780|"~     The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese~     patients with rheumatoid arthritis.~   "
137993|NCT01248767|"~     This research aims to study the future of at risk or pathological gamblers seeking~     treatment at the University Hospital of Nantes. The study focuses on socio-demographic and~     clinical data. It notably aims to study the evolution of these variables according to the~     evolution of the gambling behaviours, the step of care, the modality of care, etc~   "
137994|NCT01248754|"~     The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade~     glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit~     neurosurgeons to achieve a complete resection more frequently.~   "
137995|NCT01248741|"~     High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose~     escalation for prostate cancer. Needles are placed, the position is confirmed and treatment~     is delivered. Previously High Dose Rate prostate brachytherapy was performed under~     TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging~     which introduced a source of error through needle displacement while transporting and~     repositioning patient. Recently Varian has introduced a one-step procedure where both~     implant and planning are based on UltraSound imaging and performed without patient~     repositioning. This planning system is approved by Health Canada and is commercially~     available.~      This study will use High Dose Rate brachytherapy to treat 15 men. Treatment will be planned~     with TransRectal UltraSound but validated pre-treatment using Computed Tomography imaging.~   "
137996|NCT01248728|"~     This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism.~     Autism, originally described by Kanner in 1943, is among the most severe of~     neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting~     social and communicative functions and is also characterized by repetitive~     behaviors/restricted interests. It is also frequently accompanied by significant aggression,~     self-injury, irritability and hyperactivity, making care for these individuals an even~     greater challenge for families or institutional settings. Autism severely impacts the~     affected individual and family members, causing life-long functional impairment. In this~     protocol the investigators will use the terms autism and autism spectrum disorder (ASD)~     interchangeably to refer to Autistic disorder, Asperger Syndrome and PDD-Not Otherwise~     Specified (NOS).~   "
138008|NCT01248572|"~     The primary goal of this study is to determine the effective lens position (ELP) - or~     location an intraocular lens (IOL) sits in the eye - of the Softec HD IOL. A secondary~     study goal is to determine if measures of the eye taken prior to surgery can reliably~     predict postoperative ELP.~   "
137997|NCT01248715|"~     Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical~     and atypical bacteria that may cause community-acquired pneumonia (CAP). Influenza antiviral~     therapy in patients with suspected or confirmed influenza. However, many clinicians do not~     suspect influenza among patients with CAP or other acute lower respiratory tract illness~     (LRTI) and often do not test for influenza. Additionally, results from currently available~     diagnostic tests for influenza may be delayed and several tests have low sensitivity and~     will give false negative results. Thus, anti-influenza treatment for patients with~     hospitalized influenza CAP and LRTI is frequently initiated late if at all. There is an~     association between delayed time to administration of empiric antibiotic therapy with~     increased clinical failure and mortality. As a result, empiric antibiotic therapy for~     patients with suspect CAP is begun within 4 - 6 hours of hospitalization. This has recently~     been demonstrated for delayed antiviral treatment as well. We hypothesize that, as happens~     with early empiric antibiotics for bacterial CAP, a standardized approach of adding early~     empiric anti-influenza therapy during the influenza season to hospitalized patients with~     suspect CAP and LRTI will improve clinical outcomes of patients with influenza associated~     CAP and LRTI.~      To test our hypothesis we plan a prospective, randomized, multicenter clinical trial of~     hospitalized patients with acute LRTI, including suspect CAP, during . If early~     anti-influenza medications were not included on the patients admission orders, patients will~     be randomized to standard care, including empiric antibacterial therapy as recommended by~     ATS/IDSA guidelines plus standard influenza diagnostics and treatment (Standard of care)~     versus early initiation of empiric antiinfluenza therapy plus standard care, e.g. empiric~     antibacterial (oseltamivir group). The primary study outcome will be development of clinical~     failure and selected clinical outcomes during the 30 days after enrollment. Other clinical~     outcomes that will be compared between study groups include time to clinical stability,~     duration of hospitalization, development of cardiovascular events, re-hospitalization,~     short-term mortality (30 days), and long-term mortality (1 year). The secondary study~     outcome will be the cost-effectiveness of the intervention.~   "
137998|NCT01248702|"~     The purpose of this study is to develop and implement a critical pathway to identify~     patients with ischemic cardiomyopathy who are candidates for an implantable~     cardioverter-defibrillator (ICD). This study will also determine whether the use of the~     critical pathway for ICDs is associated with a change in the ICD referral and implantation~     rate.~   "
137999|NCT01248689|"~     One important goal in anesthetic management during ocular surgery is to provide adequate~     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients~     with glaucoma or a penetrating open-eye injury. Accurate assessment of IOP is particularly~     important in infants and children with definite or suspected glaucoma undergoing examination~     under anesthesia.~      Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic~     agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular~     surgery, the inspired sevoflurane concentration varies continuously and may have an impact~     over the IOP that could affect the conduct of surgery. In this study the investigators wish~     to evaluate whether variations in sevoflurane concentration do affect the IOP.~   "
138000|NCT01248676|"~     The purpose of this study is to determine if multi-language patients will find the~     multi-language capabilities of the online modules useful for better understanding of the~     general information regarding radiation therapy.~   "
138001|NCT01248663|"~     Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the~     pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater.~     For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and~     oncologically equivalent to the traditional whipple operation. One issue with this technique~     is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging~     between day 4 and 14 after surgery. Patients with severe DGE can not only experience~     prolonged length of hospital stay, but are also at increased risk for other complications~     like aspiration or other issues related to the inability to ingest nutrition.~      There is vast retrospective evidence and one prospective study indicating that antecolic~     reconstruction of the duodenojejunostomy can improve the rate and severity of delayed~     gastric emptying.~      The investigators have conducted a prospective randomized trial in order to test this~     hypothesis. Patients were randomized to either undergo antecolic or retrocolic~     reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria.~     In addition, a test meal including 1g paracetamol was administered to check for clinically~     inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and~     glucagon was alos measured.~   "
138002|NCT01248650|"~     The purpose of this study is to observe pharmacokinetics and safety of nalfurafine~     hydrochloride in patients receiving hemodialysis.~   "
138003|NCT01248637|"~     This study involves the administration of a hypoxia marker, pimonidazole hydrochloride,~     taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order~     to identify areas of lower oxygen content on tumor samples.~   "
138004|NCT01248624|"~     Patients with advanced cancer often have numerous physical and psychological symptoms, which~     can negatively affect their quality of life. A palliative care team of different health care~     professionals (including doctors, nurses, social workers and therapists) specializes in~     treating these symptoms and offers support for patients and their families. However,~     palliative care teams are currently involved only in the last two months of a patient's life~     or not at all.~      The main purpose of this study is to determine whether, compared to conventional cancer~     care, early involvement by a specialized symptom control and palliative care team in~     patients with advanced cancer will be associated with: better quality of life, greater~     patient and caregiver satisfaction with care, better symptom control, improved communication~     with healthcare providers and improved caregiver quality of life.~   "
138005|NCT01248611|"~     Traditionally cancer pain is treated with long acting opioids such as morphine around the~     clock. However, there is no evidence that all patients have a stable pain requiring around~     the clock medication. So far opioids for self-administration with a rapid onset of action~     have not been available. Recently a nasal formulation of fentanyl (an opioid similar to~     morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable~     pain with short duration that breaks through the otherwise stable pain controlled with the~     around the clock medication. The basic idea is that this formulation may open for patient~     controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of~     nasally delivered fentanyl. This means that the patient only takes medication when in pain.~     This single center feasibility / safety study is the first part of a study to investigate~     this alternative cancer pain treatment approach.~   "
138006|NCT01248598|"~     The purpose of this study is to study the prevalence of EBV, HCMV, HHV-6 in saliva and on~     the toothbrush patient with periodontitis.~   "
138007|NCT01248585|"~     This research is being done because is is not known if dexamethasone can prevent pain flare~     (their pain temporarily gets worse before it gets better) caused by the radiation used to~     treat painful bone metastases. Using dexamethasone to prevent pain like this has been~     studied in a few people and seems promising, but it is not clear if it can decrease the pain~     or prevent the pain flare before it happens.~   "
138009|NCT01248546|"~     The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will~     include women aged 50 to 69 years invited to the population-based mammography-screening~     program. All women attending the screening unit will be asked if they want to attend the~     trial. If so, they will be informed about the project, the technique, and the additional~     compression and radiation dose. All mammographic examinations of women attending the trial~     will be independently interpreted by four radiologists. Since the trial is part of the~     official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be~     carried out on-line into the national screening database of the NBCSP. The study will~     include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided~     detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus~     meeting for all examinations having a positive score. Recalls and diagnostic work-up will be~     according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of~     the NBCSP.~      Outcome measures will use performance indicators for organized screening programs, including~     recall rate, false positive scores, cancer detection rate, positive predictive values, and~     cancer characteristics for the individual readers of the trial.~   "
138010|NCT01248533|"~     Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for~     abdominal aortic aneurysm.~   "
138011|NCT01248520|"~     History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic~     influenza infections impart disproportionate morbidity and mortality among gravidas. The~     influenza vaccine represents a viable, preventive health intervention to mitigate disease~     burden for gravidas and their neonates[1,2]. Despite the safety and efficacy of influenza~     vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide[3]. Barriers to~     influenza vaccination during pregnancy include patient concerns about vaccine safety and~     unappreciated risk of influenza infection[4]. Cellular phone text messaging has emerged as~     an innovative technology with advantages of ubiquity, rapid, confidential information~     transmission, and low cost. Text messaging may represent an effective way to educate~     pregnant women about their particular vulnerability to influenza infection and enhance~     influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess~     whether text messaging to an outpatient obstetric population can improve maternal influenza~     vaccine uptake.~   "
138012|NCT01248507|"~     COPD patients frequently suffer intermittent exacerbations of their disease characterised by~     acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with~     significant impairment of health status, use of health care resources, poor prognosis and~     increased mortality. The development of simple and practical predictive tools would help to~     identify COPD patients at greater risk of suffering exacerbations, which is important since~     those patients would need more intense and early treatment.~      This one-year prospective cohort non-drug study will evaluate several COPD-specific~     questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk~     factors, for the composite events in study cohorts. The trial duration consists of a~     screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the~     study.~   "
138013|NCT01248494|"~     This is an open-label phase Ib multi-institution trial that evaluates the safety~     profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and~     endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy~     combination in postmenopausal patients with hormone receptor-positive metastatic breast~     cancer.~   "
138014|NCT01248481|"~     To evaluate the effectiveness of Glucobay when combined with a basal insulin under~     daily-life treatment conditions in a large sample of Korean patients.~   "
138015|NCT01248468|"~     The main purpose of this study is to compare the efficacy and safety of aspirin,~     acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of~     migraine.~   "
138016|NCT01248455|"~     Background:~        -  Recent studies have shown that smoldering multiple myeloma has a high risk of~          progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5~          years of diagnosis. People with smoldering multiple myeloma have abnormal blood test~          results that show a high level of monoclonal protein (M-protein) in the blood and of~          plasma cells in the bone marrow. There are currently no known effective treatments to~          prevent smoldering multiple myeloma from developing into multiple myeloma, and there~          are no known tests for determining whether an individual with smoldering multiple~          myeloma will develop multiple myeloma.~        -  Certain cells in the immune system, known as natural killer (NK) cells, are active~          against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like~          receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells.~          Researchers are interested in determining whether anti-KIR can be given to individuals~          with smoldering multiple myeloma to improve their abnormal blood test results.~      Objectives:~      - To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood~     test results related to smoldering multiple myeloma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with smoldering multiple~     myeloma.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          provide baseline blood, urine, and bone marrow samples before beginning the study drug.~        -  Participants will receive anti-KIR intravenously for 1 hour, and will be closely~          monitored for 24 hours after receiving the first dose. If there are no serious side~          effects, participants will receive five additional anti-KIR doses, one every other~          month, for a total of six treatment cycles.~        -  Participants will have monthly visits to provide additional blood and urine samples,~          and may have additional bone marrow biopsies as directed by the study researchers.~        -  Participants will have followup visits every 3 to 6 months for up to 5 years after~          receiving anti-KIR treatment.~   "
138017|NCT01248442|"~     In this placebo controlled study the investigators aim to investigate the effect of a 3~     month vitamin D supplementation on parameters of the immune, endocrine and metabolic system~     in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase~     of certain immune cells, which regulate immunotolerance, the investigators therefore try to~     confirm these results with a placebo group. Furthermore the investigators assess the effect~     of vitamin D on the glucose metabolism and hormone levels.~   "
138018|NCT01248429|"~     This study describes the elevation of CPK in patient treated for solid tumors by TKI~   "
138019|NCT01248416|"~     When treating very short children in puberty we are time-limited, as sex hormones cause the~     growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty,~     increase height potential, but leave children sexually infantile at a critical time in~     development. Human and animal data show that estrogen, in females and males, is a principal~     regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs),~     which block testosterone to estrogen conversion, in boys with different growth disorders, we~     have shown that AIs may have beneficial effects enhancing height potential in~     growth-retarded males, without affecting their puberty. However, no direct comparison of the~     effect of AIs alone vs. conventional GH treatment has been done to date. This study will~     assess the effect of AIs alone, GH alone and combination treatment in enhancing height~     potential in adolescent boys with idiopathic short stature.~   "
138020|NCT01248403|"~     Adult patients with gastric carcinoma which has progressed after initial treatment with a~     fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus~     placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall~     survival compared to patients who are treated with paclitaxel alone.~   "
138021|NCT01248390|"~     The purpose of this research is to see whether adding a new therapy helps people with brain~     injury focus better and think more clearly. You are being asked to participate in this~     research study because you have had a brain injury. If you decide to volunteer, you will be~     in the study for about six months.As a participant, you will be randomly assigned to one of~     2 treatment plans. Randomization is a process like flipping a coin and means you will have a~     chance of being assigned to either of the plans. One group will be given an experimental~     therapy using a metronome one hour a day, three times a week. A metronome is a device that~     produces a steady beat. You will need to keep time with the metronome doing several~     different movements. On each beat, you will be given information both through sound and on a~     computer screen about whether you were early or late and how far off beat you were. The~     tempo of the beat will be at 54 beats per minute, so you will need to process the feedback~     information very quickly to adjust your speed up or down to match the beat. The various~     movements include things like clapping hands, tapping toes, or alternating between different~     similar movements. It is hoped that the metronome will help subjects to concentrate better.~   "
138022|NCT01248377|"~     This study aims to compare the results of skin testing and ELISPOT assay in patients with a~     history of non-immediate reactions to cephalosporins~   "
138023|NCT01248364|"~     An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI~     10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2~     diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.~   "
138024|NCT01248351|"~     The objective of the study is to test the hypothesis whether or not autologous stored~     platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed~     by state-of-the-art platelet function assays.~   "
138025|NCT01248338|"~     An impairment of endothelial function plays the central role in the pathogenesis of~     cardiovascular diseases and their complications. Most of cardiovascular risk factors are~     known to impair endothelial function and the established disease further aggravates~     endothelial dysfunction.~      The aim of the present study is to investigate the effects of nebivolol or metoprolol~     succinate on endothelial function and large artery stiffness.~   "
138026|NCT01248325|"~     Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1~     ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL,~     Group B: saline).~      The subjects will use the study medication or comparative, according to their randomization,~     for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after~     initiation of treatment.~   "
138027|NCT01248312|"~     Hypercapnea is a condition where there is too much carbon dioxide (CO2) in the blood. Carbon~     dioxide is a gaseous product of the body's metabolism and is normally expelled through the~     lungs (breathed out). Hypoventilation (or respiratory depression) occurs when the~     ventilation is inadequate to perform needed gas exchange; therefore resulting in decreased~     levels of oxygen and increased levels of carbon dioxide in the blood. It can cause an~     increased concentration of carbon dioxide and respiratory acidosis. Obesity is a~     multi-system disorder, particularly involving the respiratory (lungs/breathing) and~     cardiovascular (heart/vessel) systems. Obesity increases the risks for surgical and~     anesthetic complications before, during and following surgery.~      Bariatric (weight loss) surgery is becoming a common procedure among the morbidly obese (100~     lbs or more above normal weight), with recent studies highlighting the long-term health~     implications of surgical weight reduction, to include a decreased risk of hypertension (high~     blood pressure) and diabetes (increased sugar in blood). Obese patients are at increased~     risk of sleep apnea (stop breathing while asleep) and hypoventilation even without surgery,~     and these risks increase following administration of medications typically given during and~     after major surgical procedures. Hypoventilation can lead to hypercapnea, sedation~     (sleepiness), and acidosis (blood imbalance), resulting in further respiratory compromise~     (breathing problems) and cardiac morbidity (heart problems) as well as the risks inherent in~     re-intubating (needing to have a breathing tube place down into the lungs) the~     obese.Monitoring for hypoventilation can be difficult. Quantitative capnography (measuring~     carbon dioxide) is only appropriate for intubated patients (on a ventilator - breathing~     tube), and pulse oximetry (clip on finger that measures oxygen levels) does not adequately~     detect hypoventilation in patients receiving supplemental (additional) oxygen. Serial~     arterial blood gas (blood taken from an artery to measure oxygen level in blood) measurement~     is expensive, time-consuming, and painful. Continuous respiratory rate monitoring is~     possible, and has been considered the gold standard of apnea detection (seeing stopped~     breathing), yet is seldom used. As a result of these limitations, there is currently no~     simple, cost-effective, and reliable means of detecting hypoventilation in this patient~     population either in the recovery room or inpatient unit. Transcutaneous (across the skin)~     pCO2 (t-pCO2) monitoring has been validated as a reliable and reproducible means of~     measuring pCO2 in newborn babies, and recently has also been used in adults, primarily in~     the ICU (intensive care unit) setting. When compared to standard end-tidal CO2 measurement,~     t-pCO2 correlates better with pCO2 in the intraoperative period in both thin and obese~     patients. SenTec, is the manufacturer of a device used to measure t-pCO2 for this project.~     This study is designed to detect the incidence of hypercapnea in morbidly obese~     post-surgical bariatric patients in the postoperative period using the SenTec t-pCO2~     monitor.~      Objective:To determine the incidence of hypoventilation and hypercapnea as measured by~     transcutaneous pCO2 monitoring in post-surgical bariatric patients as compared to thin~     controls.~   "
138028|NCT01248299|"~     Interest of continuing systemic chemotherapy or not , after a short initial treatment (6~     weeks) in patients who are in response or stable disease(Discontinuation design )of~     patients with metastatic oesophageal cancer of squamous cell type~      The secondary aims would be to study : toxicity, the overall survival rate, a study of costs~     and quality of life.~   "
138029|NCT01248286|"~     Food products derived from cereal grains constitute a major part of the daily diet of many~     Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an~     average. However, most of these foods are derived from refined grain. During the refining~     process grains are stripped of their bran and germ which results in depletion of several~     biologically active constituents including fiber, anti-oxidants, phytoestrogens and~     minerals. From observational studies there is evidence for a protective effect of~     whole-grain foods with regard to the development of type 2 diabetes. More recently, higher~     intake of whole grains was also associated with decreases in insulin resistance - a risk~     factor related to the development of type 2 diabetes.~      In this randomized study the investigators plan to replicate this beneficial effect of~     improving insulin sensitivity in patients with pre-diabetes and go a step further by~     exploring the potential mechanisms by which this benefit may occur. The investigators will~     assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation~     endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress~     - all of which have been shown to play an important role in the pathogenesis of diabetes~     mellitus. The investigators will also look for correlations between the levels of these~     markers with insulin sensitivity to identify potential mechanisms of pathogenesis.~   "
138030|NCT01248273|"~     The purpose of this study is to 1) test the safety of the vaccine to find out what effects,~     good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The~     vaccine in this study will contain several parts. The first part is called an antigen. These~     antigens or fingerprints are found on many cancer cells, especially from the ovaries,~     fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this~     study is to see if investigators can help the immune system to recognize that cancer cells~     are not normal and should be removed.~   "
138031|NCT01248260|"~     The purpose of this study is to find out if folic acid prevents of the reduction of fetal~     body and brain size in infants whose mothers smoke.~   "
138032|NCT01248247|"~     Different people have different biomarkers (chemical markers in the blood that may be~     related to your reaction to study drugs). If researchers know about your biomarkers before~     you receive treatment, they may be able to prescribe a treatment that is better suited to~     your body's specific needs.~      The goal of this clinical research study is to learn if drug or drug combinations based on~     your biomarkers can help to control NSCLC. The safety of these drug combinations will also~     be studied.~   "
138033|NCT01248234|"~     This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide~     a more stable blood pressure when used to put elderly hypertensive patients to sleep than~     either drug used alone.~   "
138057|NCT01247922|"~     Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205~     and either progressed while on study or discontinued due to unacceptable toxicity related to~     etoposide were allowed to participate in this study to assess the safety profile of~     single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.~   "
138034|NCT01248221|"~     The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis~     breath test and scintigraphy in healthy subjects and subjects with dyspepsia.~      Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces~     of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and~     13C-Spirulina platensis.~      Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body~     tissue is produced through the detection of radiation emitted by a radioactive substance~     administered into the body. The location of a standard meal in the digestive system will be~     measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after~     the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical~     diagnostic procedures.~      Spirulina platensis is blue - green algae, which is very similar to the naturally occurring~     spirulina sold in health food stores as a dietary supplement. The spirulina platensis has~     been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as~     1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will~     be measured by breath samples at periodic intervals before and after a standard meal. The~     FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.~   "
138035|NCT01248208|"~     With the growing public health concerns of seasonal influenza and H1N1 in the United States,~     the primary means by which this can be addressed is with prevention, namely, vaccination~     against the influenza virus. The only individuals not able to receive this vaccination in~     the primary care provider's office are those patients with egg allergies and, in rare~     circumstances, individuals with allergies to other components of the vaccine. Current~     guidelines allow for the administration of the influenza vaccine to patients with egg~     allergy using vaccines with low egg protein (ovalbumin) content or by using skin testing~     followed by a 5-dose desensitization protocol. Since this is impractical to perform in the~     primary care office and cumbersome for allergists, many egg-allergic patients simply do not~     receive the influenza vaccine, leaving them more vulnerable to the disease and more likely~     to become a source of contagion.~      Several studies have suggested that influenza vaccination using a 1-2 dose protocol may be~     safe. This fact is due in large part to the low ovalbumin (egg protein) content in modern~     influenza vaccines. All studies of influenza vaccination in egg-allergic patients have been~     done using intramuscular trivalent inactivated influenza vaccine (TIV). However, the~     trivalent live-attenuated, cold-adapted influenza vaccine (LAIV), which is delivered~     intranasally, has a lower published ovalbumin content than the injectable vaccines,~     suggesting that it may also be well-tolerated by egg-allergic patients. According to several~     studies, LAIV may be more efficacious than TIV in children.~      It is the goal of the investigators to evaluate the safety of immunizing egg-allergic~     individuals with the LAIV.~   "
138036|NCT01248195|"~     The purpose of the study is optimising current treatments in schizophrenia and explore novel~     therapeutic options for schizophrenia. The study intends to both address basic, but so far~     unanswered, questions in the treatment of schizophrenia and develop new interventions. It is~     expected that the project will lead to evidence that is directly applicable to treatment~     guidelines, and will identify potential mechanisms for new drug development.~   "
138037|NCT01248182|"~     The purpose of this study is to determine the bone to skin depth for groups of lean, obese~     and morbidly obese patients. This information will be potentially helpful with implant~     design for obese and lean patients.~   "
138038|NCT01248169|"~     The utilization of external cardiohemodynamic patient assessment, applying non-invasive~     stick-on contact patches to the mother's neck on either side and chest wall on either side,~     enables the practitioner to have information about the patient's cardiac function and~     vascular status beyond simply blood pressure and pulse. This information, once collected,~     should open the practitioner's eyes to better assess the patient's disease status and her~     response to therapy. We will use this information to compare the effectiveness of the two~     standard medications used for treatment of maternal high blood pressure.~   "
138039|NCT01248156|"~     Atrial fibrillation (AF) is the most prevalent heart rhythm disorder in the United States,~     affecting 2.5 million individuals in whom it may cause stroke, palpitations, heart failure,~     and even death. Unfortunately, therapy for AF is limited. Anti-arrhythmic or~     rate-controlling drugs are poorly tolerated, with frequent side effects and do not reduce~     stroke risk. Ablation is an emerging, minimally invasive therapy that has attracted~     considerable attention because it may eliminate AF. Unfortunately, AF ablation is~     technically challenging, with a success of only 50-70% (versus >90% for other arrhythmias)~     and serious risks. A major cause of these limitations is that the mechanisms for human AF~     are not known and thus ablation cannot be directed to them. As a result, AF ablation is~     empiric and results in extensive destruction of the atrium.~      This project will perform research to better understand AF and determine if abnormal~     activity in small regions or more widespread regions of the heart cause AF. By performing~     these studies in patients during clinical procedures, this project may lead to a paradigm~     shift in the understanding and treatment of AF.~   "
138040|NCT01248143|"~     Type 2 diabetes is common in ethnic and, minority groups in developing and developed~     countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and~     Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya~     preparation and green tea infusates in latent diabetes (individuals newly diagnosed as~     diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically~     modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation~     end-products which play a role as proinflammatory mediators in gestational diabetes can~     accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction~     with high-affinity receptors located on monocytes and macrophages can enhance the production~     of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis~     factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial,~     mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of~     cardiovascular complications. The clinical markers include C-reactive proteins (inflammation~     indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides,~     and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides,~     total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated~     protein C affects the permeability of the glomerular capillary wall and enhances apoptosis~     of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology~     of diabetic nephropathy. A second phase of the study is expected to commence after the first~     16 weeks in order to assess the ability of the dietary factors to modulate atheroma~     formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis~     of diabetes. This will be expected to last up to 3 years.~   "
138078|NCT01247649|"~     The present study is aimed to evaluate the feasibility of a new noninvasive method to~     measure continuous glucose values using electromagnetic radiation.~   "
138041|NCT01248130|"~     The primary aim of this study is to examine the efficacy and tolerability of short-term~     omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The~     investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core~     and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be~     safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the~     neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The~     investigators hypothesize that omega-3 fatty acids will be efficacious in improving~     cognitive functions in youth with ASD.~   "
138042|NCT01248117|"~     Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal~     choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA~     approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.~   "
138043|NCT01248104|"~     We hypothesize that tranexamic acid administration will be associated with 25% improvement~     in the volume of blood loss and red blood cell (RBC) administration, with no increase or a~     decrease in perioperative complications~   "
138044|NCT01248091|"~     Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine~     devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy.~     Unfortunately, fear of IUD insertion in women who have not had children is common among~     health care providers and women alike, and this limits IUD use. To increase acceptance of~     this highly effective contraceptive, there is need to investigate novel, low cost, easily~     applied and accessible techniques to improve the insertion experience. This is a pilot study~     to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an~     intervention to improve the IUD insertion experience for both patient and provider.~   "
138045|NCT01248078|"~     In this prospective, randomized, placebo controlled trial the investigators were able to~     demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus~     placebo, irrespective of the timing of administration, ie before skin incision or after~     umbilical cord clamping~   "
138046|NCT01248065|"~     The purpose of the study is to find out if taking vitamin D in addition to an asthma~     controller medication helps to prevent worsening of asthma symptoms and asthma attacks.~   "
138047|NCT01248052|"~     This is a two part study (Parts A and B), the purpose of which is to determine the safety of~     LY2979165 in healthy people, and any side effects that might be associated with it, and to~     understand how the body handles LY2979165. In addition, Part B, will also look at levels of~     LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.~   "
138048|NCT01248039|"~     This study wish to show if the preoperative level of pain, function or activity for hip and~     knee arthroplasty patients has any predictive value of the time it takes to fulfill the~     well-defined discharge criteria.~   "
138049|NCT01248026|"~     The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of~     cardiovascular disease (CVD) and the clinical benefit of lowering LDL-C in high-risk~     patients have both been well established. The key contribution of the intestine to whole~     body cholesterol homeostasis and thus to regulating plasma cholesterol concentrations has~     also been recognized over the last years. It is now clear that cholesterol homeostasis and~     hence plasma LDL-C concentrations are maintained by a fine-tuned balance between intestinal~     cholesterol absorption and endogenous cholesterol synthesis.~      Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost~     entirely dependent on its solubilizing capacity in bile acid micelles within the intestine.~     Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product~     of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect~     on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique~     milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during~     the manufacturing of dairy cream into butter. Most of the work done so far on the subject~     has focused on phospholipids purified from MFGM, while overlooking the complex and entire~     MFGM mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our~     knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol~     concentration in human.~      The general objective of this research project is to investigate for the first time the~     impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More~     specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C~     and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and~     synthesis.~   "
138050|NCT01248013|"~     The primary goal of the study was whether gut focused hypnotherapy, in a group format, was~     successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary~     goal was to see if any outcome predictors could be determined.~   "
138051|NCT01248000|"~     Positron Emission Tomography (PET) represents a step forward in the definition of response~     to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the~     early assessment of response has been described as the most important tool for predicting~     the risk of disease progression. As no data are available to support the use of early~     assessment of response for adapting and modifying subsequent treatment, the use of PET~     should be limited only to patients enrolled in clinical trials. Irrespective of~     recommendations PET scanning is included in the current management of patients with HL at~     baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed~     to verify how PET is currently used in the clinical setting and to assess if and how results~     of PET scanning are used for supporting treatment and clinical decisions.~   "
138052|NCT01247987|"~     The purpose of this study is to determine if cryopreservation at the blastocyst stage~     followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear~     oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer.~     Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.~   "
138053|NCT01247974|"~     This is a multi-center, prospective, randomized and controlled clinical trial comparing the~     safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of~     new onset postoperative atrial fibrillation by circumferentially reconstructing the normal~     pericardial anatomy following isolated, first-time, CABG procedures compared to subjects~     that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical~     sites in the U.S.~   "
138054|NCT01247961|"~     This pilot trial will evaluate the following in patients with acute pancreatitis:~        1. Safety profile of early treatment with intravenous dexamethasone~        2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis~        3. Provide preliminary data on potential impact of early treatment with steroids on~          clinical outcomes~   "
138055|NCT01247948|"~     The purpose of this study is to investigate the difference of the accuracy and safety~     between traditional spine surgery and computer assisted navigation system spine surgery.~   "
138056|NCT01247935|"~     To compare the effectiveness of acupuncture and transcutaneous electrical nervous~     stimulation (TENS) in reducing patient's discomfort during colonoscopy~   "
138058|NCT01247909|"~     This study aims to improve the outcome of infants (<2 months) with severe sepsis and~     meningitis at the Queen Elizabeth Central Hospital, Blantyre, Malawi.~      Currently WHO recommends the treatment of infant severe sepsis and bacterial meningitis with~     14 to 21 day course of penicillin and gentamicin as first line. The second line treatment is~     cefotaxime or ceftriaxone.~      Severe bacterial infections are common in infants under 2 months of age and the mortality is~     very high (~50%). There are several reasons for this; one is that the first line antibiotics~     used are no longer as effective as they used to be. Bacterial resistance to the first line~     antibiotics has increased and some infections especially of the central nervous system may~     only be partly treated and not eradicated by present therapy. First line treatment is cheap~     and available but requires 4 injections a day, for at least 14 days, a total of 58~     injections. Many mothers find this number too much and abscond. The investigators second~     line therapy is ceftriaxone which is also available and cheap and the advantage of being~     given as a daily injection. The disadvantage is that it can cause (reversible) jaundice~     particularly in premature babies and it must not be given with calcium products. The~     investigators do not give calcium to the investigators infants as the investigators cannot~     routinely check electrolytes. All the most common causes of bacterial meningitis in this age~     group in the investigators setting are sensitive to ceftriaxone.~      The investigators wish to undertake an open randomized trial of penicillin and gentamicin v~     ceftriaxone as first line treatment for infant meningitis. The investigators are able to~     monitor for side effects.~      The investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the~     penicillin and gentamicin group.~   "
138059|NCT01247896|"~     PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     purpose of the study is to evaluate the safety and tolerability of PF-05190457 after~     administration of a single dose to healthy volunteers and to evaluate the plasma drug~     concentrations after single dose in healthy volunteers.~   "
138060|NCT01247883|"~     This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when~     respectively given orally as a single tablet dose and a single dose of a solution.~   "
138061|NCT01247870|"~     The purpose of this study is to determine the effect of a tablet medication, called~     metformin, in flare-ups (exacerbations) of chronic obstructive pulmonary disease. The~     investigators believe that metformin may effectively control the blood sugar level during~     COPD exacerbations. This is important because there is evidence that a high blood sugar~     level during exacerbations may be linked with a worse prognosis. The investigators also~     think that metformin may have other potentially useful effects on inflammation, antioxidant~     levels, the effectiveness of steroid treatment, and recovery.~   "
138062|NCT01247857|"~     Intraperitoneal nebulization of local anesthetic is a novel approach to pain management~     after laparoscopy. Preoperative compared with postoperative administration of analgesia~     remains controversial. This randomized, double blind, placebo-controlled trial compared the~     analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in~     patients undergoing elective laparoscopic cholecystectomy.~   "
138063|NCT01247844|"~     The objective of this research study is to evaluate the safety and acceptability of the~     Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device~     with a potential role in the safe and cost-effective delivery of circumcision services. The~     device, developed in China, consists of two concentric plastic rings. Following a ring~     penile block, the smaller ring is fitted at the base of the coronal sulcus. The foreskin is~     everted over the inner ring and the larger outer ring is secured over the inner ring. The~     foreskin is excised and several nicks are made on the incision line to prevent formation of~     a constricting, circumferential scab. No suturing is required.~      In this study, the investigators will evaluate wound healing of men randomized to removal of~     the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the~     device on for 14 or 21 days constitutes extended wear of the device.~      Sites: Homa Bay District Hospital, Nyanza Province, Kenya~   "
138064|NCT01247831|"~     The purpose of this study is to examine the influence of selective laser trabeculoplasty~     (SLT) on ocular rigidity in glaucoma patients.~   "
138065|NCT01247818|"~     PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical~     administration to the skin, and is being studied for the treatment of cutaneous skin~     disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of~     subjects randomized sequentially by center to one of four treatment cohorts will assess~     efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque~     psoriasis.~   "
138066|NCT01247805|"~     The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10~     Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil~     Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet~     in Healthy Volunteers.~   "
138067|NCT01247792|"~     The care of patients with sepsis-related organ failure on the intensive care unit (ICU)~     often includes end-of-life decision (EOL-D) and communication of such decisions to~     relatives. This increases the psychological burden for caregiver and relatives.~      The investigators intend to assess the prevalence and impact of EOL-D on ICU care-givers and~     relatives (before) and to use this data to develop and implement standard operating~     procedures (SOPs) for improved decision-making and communication of these decisions~     (after).~      The hypothesis is that an improved communication strategy will reduce symptoms of burnout in~     caregivers and symptoms of anxiety and depression in relatives.~   "
138068|NCT01247779|"~     The purpose of this study is to compare perioperative morbidity of coelioscopy versus~     robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.~   "
138069|NCT01247766|"~     The purpose of this study is to compare the incidence rates of infection, malignancy and~     death among patients with rheumatoid arthritis who are treated with abatacept and those who~     are treated with other anti-rheumatic medications for rheumatoid arthritis.~   "
138079|NCT01247636|"~     The purpose of this randomized controlled trial is to evaluate the effectiveness of an~     exercised-based programme developed for older people admitted at a geriatric outpatient~     clinic and to see if a home-exercise program enhances the effect. The outcomes considered is~     health-related quality of life, balance-self confidence, balance and mobility.~   "
138070|NCT01247753|"~     The prevalence of Gestational Diabetes Mellitus (GDM) in Australia is approximately 5%-8%,~     with up to one third of all parous women who develop type 2 diabetes having a previous~     history of GDM. Research to determine strategies to delay or prevent the development of or~     progression to diabetes is vital, particularly in population groups that are at higher risk,~     such as GDM, and overweight women (BMI>=25). Currently, follow-up or post-partum support for~     women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose~     tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized~     controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post-partum~     intervention designed to increase physical activity in women with previous GDM may be~     feasible. A recent study in the United States recruited women with recent GDM into an RCT~     where the control group received usual care and the intervention group received a web based~     walking program. Although the results of this study are limited, they did show an increase~     in pedometer steps/day between baseline and end of study. Dietary intervention has been~     proven to increase probability of weight loss, so a strategy of combining both a pedometer~     and nutrition based program may prove to be more successful for long term improvement of a~     healthy lifestyle to prevent type 2 diabetes.~      Study hypothesis: A pedometer based intervention to encourage physical activity, combined~     with nutrition coaching in women with recent GDM and BMI >= 25 will result in increased~     weight loss, improved insulin sensitivity and increased physical activity when compared with~     standard care.~   "
138071|NCT01247740|"~     The purpose of the study is to investigate the efficacy and safety of a convenient~     3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a~     conventionally compounded monobag for parenteral nutrition.~   "
138072|NCT01247727|"~     National Taiwan University Hospital is the leading center for care of patients with~     extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes~     are still lacking in patients with the ECMO support. The aim of this study is to collect the~     electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed~     by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability,~     including linear and non-linear analysis is calculated to address the association with~     outcomes of patients with ECMO. In addition, we collected the demographics, body~     temperature, respiratory rate, and blood pressure to investigate the causes of heart rate~     variability.~   "
138073|NCT01247714|"~     The hypothesis of the proposed trials is that the regular intake of a specific diet designed~     for enteral nutrition of type 2 diabetic patients results into a better nutritional status.~     Thus, the aim of the study is to scientifically evaluate the healthy effects of the~     administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).~   "
138074|NCT01247701|"~     In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with~     the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an~     attempt to improve engraftment rate and reduce infections, the investigators are going to~     incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been~     widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen.~      Encouraging data on adding fludarabine to the SCT regimen have been reported. A~     fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could~     conceivably allow engraftment of stem cells from alternative donors in hematologic~     malignancies patients with acceptable engraftment rates and low transplant-related~     mortality. Regimen-related toxicity is believed to be a major contributing factor to GVHD.~     Therefore this approach may also lead to reduced GVHD, as some investigators have suggested.~      In an attempt to decrease the rate of viral infection and reactivation, the investigators~     will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate~     Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft~     failure with the removal of the ATG/Campath. The investigators anticipate that the removal~     of ATG/Campath will facilitate immune reconstitution more efficiently after receiving a~     UCBT.~   "
138075|NCT01247688|"~     The purpose of this study is to determine the safety and effectiveness of UCBT to treat~     patients with lymphoid hematological diseases and to see if this treatment can decrease the~     incidence of leukemia relapse, GVHD and infections.~      These patients have a type of blood cell disorder that is very hard to cure. This treatment~     that is being used in this trial is known as a stem cell transplant. This treatment might~     help the patient live longer without the disease. It uses much stronger doses of drugs and~     radiation to kill the diseased cells that could be given without the transplant. We also~     think that the healthy cells from the donor may help fight any diseased cells left after the~     transplant.~      For the transplant to take place, we will administer stem cells from a 'donor' whose cells~     best 'match' the patient's. In this study umbilical cords will be the source of the stem~     cells. Before the transplant, two very strong drugs plus total body irradiation will be~     given to as preconditioning. This treatment will kill most of your blood-forming cells in~     the bone marrow. The patient will then get then healthy stem cells.~      If the patient has the disease in the central nervous system (CNS), they will receive~     radiation to the head and spine before starting the conditioning. This is to try to get~     disease control in the CNS. Radiation will not be given for children under 2 yrs old.~      Currently, many umbilical cord blood units are available in public banks for transplantation~     in patients lacking bone marrow donors. UCB transplants (UCBT) may offer several advantages~     over adult bone marrow or peripheral blood stem cell transplants, including:~        1. rapid availability,~        2. absence of donor risk,~        3. low risk of transmissible infectious diseases,~        4. low risk of acute GvHD (Graft vs. Host Disease)~      The three main causes of death after umbilical cord blood transplantation for these kind of~     disorders are graft failure, infection and disease relapse.~      In this study we are trying to address these three problems:~      To help improve engraftment we will add the drug Fludarabine to Cytoxan and total body~     irradiation. Fludarabine is a very strong medicine. We will try to decrease infections and~     reduce leukemia relapse by using fludarabine instead of antithymocyte globulin (ATG).~   "
138076|NCT01247675|"~     This study investigates the pharmacokinetic profile (PK) and pharmacodynamic response (PD)~     of three different doses of ACP-001 given once-a-week compared to one dose-level of an~     approved daily human growth hormone product over a period of 4 weeks (4 weekly~     administrations versus 28 daily administrations).~   "
138077|NCT01247662|"~     Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder with prominent~     reciprocal social and communication impairment and restricted repetitive behavior or~     interest. ASD is a highly heritable disease with tremendous impact on individuals, families,~     and society. In addition to the interview instruments, self-administered rating scales are~     commonly used in screening, assessment of symptoms' change, and evaluation of intervention~     effects. The Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the~     Autism Spectrum Quotient are internationally widely used rating scales measuring autistic~     traits in both clinical and community samples in western counties. Establishment of~     internationally-recognized reliable and valid instruments is not only useful for clinical~     screening, but also helpful in future functional outcomes, neurocognitive, genetic and brain~     imaging studies.~   "
138080|NCT01247623|"~     Primary objective: Determination of safety and tolerability of GV1001 administration~     combined with Temozolomide (based on blood samples and adverse events).~      Feasibility of combining active immunisation with Temozolomide treatment. Determination of~     immunological response after administration of GV1001 and Temozolomide as measured by~     presence of DTH skin test reaction and specific T-cell responses.~      Secondary: Evaluation of objective tumour response~      The trial is an exploratory study which main objective is to estimate safety and feasibility~     of combining active immunisation with chemotherapy. However, the trial may also indicate the~     efficacy of the combination.~   "
138081|NCT01247610|"~     Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%),~     early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high~     heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much~     more attention in Western studies in the past decade; however, there has been no such study~     in Asian countries. The ultimate goals of this longitudinal follow-up study are to~     investigate the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD)~     and their healthy controls at young adulthood as the primary aim; and to test whether~     structural and functional brain connectivity can be endophenotypes of ADHD, to localize the~     brain area that are corresponding to methylphenidate treatment effects, and to identify the~     genetic variants corresponding to the persistence of ADHD, treatment effect of~     methylphenidate, neurocognitive dysfunction, and structural and functional dysconnectivity~     in the brain as the secondary aims. With the accomplishment of these goals, this study will~     provide the first-hand data on adult ADHD in non-western countries, and will be one of few~     world-class studies on the topics of neurocognitive and imaging genomics on adult ADHD.~   "
138082|NCT01247597|"~     Background:~      - Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with~     other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age.~     Recently, it has been shown that this condition can be inherited (e.g., mutation of the~     DICER1 gene). Researchers are studying both clinical and genetic aspects of this newly~     described condition. They are interested in collecting further medical history and genetic~     information on individuals and close relatives of individuals who have PPB or other rare~     associated tumors.~      Objectives:~      - To study individuals with a personal or a family history of pleuropulmonary blastoma (PPB)~     or other rare tumors that can be associated with PPB (e.g., cystic nephroma, nasal~     chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell tumors, ocular~     medulloepithelioma).~      Eligibility:~        -  Individuals who have been diagnosed with PPB and/or PPB-related tumors.~        -  Close blood relatives (e.g., parents, siblings, grandparents) of individuals who have~          been diagnosed with PPB and/or PPB-related tumors.~      Design:~        -  Interested participants can enroll or inquire about this study by calling~          1-800-518-8474.~        -  Participants will be asked to complete family history and medical history~          questionnaires. They will complete the questionnaire if they are at least 18 years of~          age, or another person will complete the questionnaire if the key family member is too~          young to do so on his or her own.~        -  Participants will be asked to sign a medical record release form to allow researchers~          to examine detailed medical history information.~        -  Participants may be asked to have a physical examination and imaging studies, provide~          blood and saliva samples, or provide tumor tissue from prior biopsies or cancer~          surgeries.~        -  Annually, participants will update the family history and individual information~          questionnaires to document important changes in medical history, and will also update~          the medical record release form. Participants may be asked to provide additional cheek~          lining cells and/or blood samples, as well as tumor tissue from any new or planned~          biopsies or tumor surgeries.~        -  Treatment will not be provided as part of this protocol.~   "
138083|NCT01247584|"~     RATIONALE: Studying bone marrow samples from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is studying biomarkers in samples from young patients with~     acute myeloid leukemia.~   "
138084|NCT01247571|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to~     the tumor.~   "
138085|NCT01247558|"~     This study will be an observational cohort study utilizing administrative claims data with~     100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria~     and 400 propensity score matched patients meeting the same criteria to serve as a control~     cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore~     Integrated Research Database for claims submitted during the time period of 01/01/2002~     through 06/30/2007.~   "
138086|NCT01247545|"~     Coronary heart disease (CHD) is the leading cause of death in the UK, accounting for 124,000~     deaths (2006) and costing the UK economy over £7.9 billion a year. Patients with severe CHD~     are usually treated by coronary artery bypass graft (CABG) surgery, the risks of which are~     increasing due to older and sicker patients being operated on. New treatment strategies are~     therefore required to improve health outcomes in these high-risk patients undergoing CABG~     with or without valve (CABG±valve) surgery.~      The hypothesis tested in this research proposal is that remote ischaemic preconditioning~     (RIC), a virtually cost-free, non-pharmacological and simple non-invasive strategy for~     reducing the damage to the heart muscle at the time of surgery, improves health outcomes in~     high-risk patients undergoing CABG±valve surgery.~      In this research project, 1610 high-risk patients undergoing CABG±valve surgery will be~     recruited via 28 UK hospitals performing heart surgery. Patients will be randomly allocated~     to receive either RIC or control. For RIC, a blood pressure cuff will be placed on the upper~     arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown~     in the investigators pilot studies to reduce damage to the heart muscle by up to 40% during~     CABG±valve surgery. The investigators will determine whether RIC can improve health outcomes~     in terms of better patient survival, less heart attacks and strokes, shorter hospital stay;~     less damage to the heart, kidney and brain during surgery; better heart function~     post-surgery and less chance of developing heart failure; better exercise tolerance and~     quality of life.~   "
138098|NCT01247389|"~     Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that~     laparoscopic colon resection would result in fewer incisional hernias, prospective studies~     demonstrate a similar incidence to open surgery. Observational studies suggest that the rate~     of incisional hernia after laparoscopic colon resection may be reduced with the use of a~     transverse compared to a midline extraction incision. However, no randomized trails are~     available, and a midline extraction incision for hemicolectomy remains the standard current~     approach. The investigators hypothesize that the use of a lower abdominal transverse muscle~     splitting incision for specimen extraction in laparoscopic colon surgery will result in~     fewer incisional hernias compared to a midline periumbilical extraction incision.~   "
138199|NCT01246258|"~     The purpose of this study is to determine whether patients with primary ciliary dyskinesia~     (PCD) have reduced or absent otolith function.The otolith system is a specific part of the~     inner ear vestibular (balance) system that detects linear movement.~   "
138087|NCT01247532|"~     The purposes of the proposed study are (1) to collect data on the feasibility of offering~     Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce fatigue and~     psychological distress in cancer patients who are not in active treatment for their cancer~     and (2) to estimate effect sizes of the intervention for fatigue, depression, anxiety, and~     sleep disturbance. The investigators also will obtain preliminary effect sizes of the degree~     to which the intervention increases mindfulness, and the investigators will evaluate dosage~     effects. Findings will suggest whether a future randomized controlled trial with~     cancer-related fatigue (CRF) as the primary outcome is feasible and warranted.~      Participants will be randomly assigned to either the MBSR intervention arm or to a wait-list~     control arm. The MBSR intervention will consist of a weekly 2-hour class to be held for~     seven consecutive weeks in the Indiana University Simon Cancer Center Pavilion; the class on~     week six will be extended to a 3-hour retreat. Participants will be invited to engage in~     daily home practice of meditation and other mindfulness exercises. All participants will~     complete a series of self-report questionnaires prior to the start of the classes,~     immediately following the end of classes, and 1 month after the class ends. Those in the~     intervention arm will begin the MBSR class the week after enrollment; the control group will~     be offered the same 7-week program after 1-month post-intervention follow-up assessments are~     completed—approximately 13 weeks after enrollment.~      Primary Aim 1: Obtain preliminary RCT effect sizes for changes in fatigue of an MBSR~     treatment group compared to a wait-list control group.~      Hypothesis 1: Immediately post-intervention (T2), improvements in fatigue compared to~     pre-intervention (T1) will be greater in the treatment group than the control group.~      Hypothesis 2: At 1 month post intervention (T3), improvements in fatigue compared to~     pre-intervention (T1) will be greater in the treatment group than improvements in the~     control group.~   "
138088|NCT01247519|"~     The investigators will perform and evaluate a post-hospitalization telecare system for~     compensating the discontinuity from the hospitalist care system.~   "
138089|NCT01247506|"~     The purpose of this study is to identify different genetic features in hepatocellular~     carcinoma. It will assist in predicting individual risks of disease progression and would~     help to clarify pathophysiological mechanisms of HCC.~   "
138090|NCT01247493|"~     A phase II clinical trial evaluating the efficacy and tolerability of induction and~     consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin~     (modified-FLAI) in the elderly patients with acute myeloid leukemia.~   "
138091|NCT01247480|"~     Major Aims of study:~        1. To create a gene expression-based prognostic device that complements or exceeds the~          prognostic utility of conventional biomarkers of breast cancer outcome.~        2. To identify one or more clinical subgroups of patients for which the prognostic device~          outperforms, or substantially adds to, the prognostic performance of conventional~          markers that currently determine therapeutic strategies.~      Sub-Aims of study:~        1. Assess the prognostic value of the multiple gene expression signatures, alone and in~          combination, using a large cohort of breast cancer patients for which pathology,~          treatment and outcome is available. A training and testing design is proposed.~        2. Evaluate the utility of a prognostic device that measures gene expression levels from~          formalin-fixed paraffin-embedded specimens (FFPEs) of primary resected tumors. The~          investigators will utilize the Affymetrix Quantigene 2.0 Assay and/or the Illumina~          BeadXpress VeraCode DASL Gene Expression Assay (FDA-approved IVDMIA.)~        3. For specific clinical subgroups of patients/tumors, the investigators will~          mathematically identify additive or synergistic prognostic relationships between genes~          and gene signatures that, in combination, will yield maximal risk prediction (distant~          metastases-free survival) for patients.~        4. Compare the prognostic utility of the investigators device to that of the conventional~          prognostic variables that are currently used to determine therapeutic strategy.~        5. Incorporate the prognostic signatures into a practical prognosis algorithm that seeks~          to include conventional measures of outcome such as tumor size, histologic grade, nodal~          status, patient age, or Nottingham index, etc.~      The investigators hypothesize that adequate quality and quantity of tumor RNA may be~     extracted from archival paraffin-embedded tumor specimens for gene expression profiling, and~     that archival tumor-derived genomic signatures may be used as prognosticators or predictors~     in breast cancer.~   "
138092|NCT01247467|"~     A number of prognostic and/or predictive genomic signatures for breast cancer have been~     developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed~     protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded~     (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene~     signatures and compare them with conventional clinical prognosticators and predictors. As~     the investigators plan to use archival tumor samples that dates back to the 1990s, the aim~     of this pilot study is to first analyze 10 anonymized samples to determine the feasibility~     of running these assays on old archival blocks. The information generated will help us~     determine whether very old samples (diagnosed before 2000) may be selected for the actual~     study.~   "
138093|NCT01247454|"~     There will be no significant decrease in the use of low dose acetylsalicylic acid (ASA)~     therapy for primary prevention across the three intervention arms from baseline to~     completion of the project.~      There will be no significant differences in the percentage of patients with diabetes~     mellitus greater than 44 years of age on low dose ASA therapy for primary prevention across~     the three arms of the study using repeated measures from baseline to completion of the~     project.~   "
138094|NCT01247441|"~     The Breast Cancer Registry aims to collect clinical data of all breast cancer patients~     diagnosed and/or treated in the National University Hospital, with the goal of understanding~     risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer~     in Singapore. This information will contribute to improving management of breast cancer~     patients.~   "
138095|NCT01247428|"~     The DESSOLVE I clinical trial is to assess the safety and performance of the~     sirolimus-eluting MiStent SES.~   "
138096|NCT01247415|"~     During the 2009-2010 immunization campaign against pandemic H1N1, some people reported~     having allergic-like reactions (anaphylaxis(a shock-like reaction), hives, swelling, etc.).~     A vaccine allergy may be more or less severe or intense. Patients may have skin reactions~     (rash with or without itching), respiratory problems (cough, spasm of the airways),~     angioedema (swelling) of various body parts (face, eyelids, throat etc.) and circulatory~     problems (low blood pressure or shock). Anaphylaxis is a severe allergic reaction that can~     sometimes be fatal. Other people vaccinated against pandemic H1N1 had an oculo-respiratory~     syndrome. Oculo-respiratory syndrome (ORS) is also a reaction to the influenza vaccine,~     which includes symptoms such as bilateral conjunctivitis (red eyes) with swelling of the~     face or respiratory symptoms (chest tightness, coughing, a sensation of throat closure,~     difficulty swallowing, hoarseness, wheezing or difficulty breathing). The investigators know~     that ORS is not a true allergic reaction. Because many signs and symptoms of ORS are similar~     to those observed during an allergic reaction, it is often difficult to distinguish ORS from~     an allergic reaction.~      This study will compare three groups of patients: those who had allergic-like reactions,~     those who had ORS and vaccinated individuals who had no such adverse events. Pregnant women~     cannot participate in this study. The study has three goals. First, the investigators want~     to determine, among those who had allergic-like reactions after influenza vaccination, what~     proportion (percentage) of these people are actually allergic to the vaccine or its~     components. Second, among those who are not allergic to the vaccine, which other processes~     may have caused these symptoms. Finally, the investigators will try to identify whether~     there are features that distinguish patients who have a true allergic reaction from those~     affected by ORS, and those that had no adverse events.~   "
138097|NCT01247402|"~     Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial,~     in which consecutive patients candidates for percutaneous intervention of angioplasty to~     treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will~     be assigned to one of two study arms:~        1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)~        2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).~      Purpose:~      To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous~     transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents~     compared to standard percutaneous transluminal angioplasty (sPTA).~   "
138099|NCT01247376|"~     Abstract~      Background:~      Local external cooling of the postoperative field is a treatment paradigm aiming for~     enhanced recovery after joint surgery. It is supposed to reduce pain and improve~     mobilization, enabling same day surgery.~      Hypothesis:~      Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and~     also be reflected by changes in local levels of metabolic and inflammatory variables in the~     synovial membrane.~      Study design:~      Prospective randomised study; Level of evidence 1.~      Methods:~      Forty-four otherwise healthy patients were included in the study and randomised to~     systematic cooling and compression or NO cooling and compression after knee arthroscopy.~     Microdialysis of the synovial membrane was performed postoperatively with measurements of~     PGE2, glucose, lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local~     temperature was monitored as well as postoperative pain (VAS and NRS).~      Results:~      The application of a cooling and compression device after knee arthroscopy resulted in~     significantly lower temperature in the operated knee (skin, joint capsule and~     intraarticularly).~      The cooling and compression diminished energy requirements in synovial tissue and a 3~     temperature sensitive influence on inflammation (PGE2) were shown. No effect on~     postoperative pain was detected.~      Conclusion:~      Local cryotherapy and compression after knee arthroscopy significantly lowered local knee~     temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.~      Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory~     effect induced by postoperative local cooling and compression. Hypothermia is proposed to~     have a protective effect in ischemic tissue. This is probably due to a decreased metabolic~     rate and therefore decreased energy requirements as shown by stable levels of lactate~     despite lower blood flow indicated by increasing ethanol ratio.~   "
138100|NCT01247363|"~     Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes.~     Study subjects will receive once daily doses of LY2608204 for a total treatment duration of~     up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until~     reaching the highest dose that they can tolerate.~      Continuous glucose monitoring devices will be employed for each patient to monitor for~     hypoglycemia during study treatment. Dose titration and dose reduction is determined for~     each individual patient based on their safety and glycemic data.~   "
138101|NCT01247350|"~     To evaluate the safety and tolerability of LY3009104 when given orally as single and~     multiple doses in Japanese healthy subjects.~   "
138102|NCT01247337|"~     A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in~     combination with systemic gemcitabine and capecitabine in combination with cetuximab in~     patient with non-resectable liver metastases from cholangiocarcinoma.~   "
138103|NCT01247324|"~     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy~     and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in participants with~     relapsing multiple sclerosis. Participants will be randomized to receive either in Group A,~     ocrelizumab 600 milligrams (mg) intravenously (iv) every 24 weeks plus Rebif placebo~     subcutaneously (sc) three times weekly, or, in Group B, Rebif 8.8 micrograms (mcg) (Weeks 1~     and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) sc three times weekly~     plus ocrelizumab placebo iv every 24 weeks. Planned duration of double-blind treatment is 96~     weeks. Participants who complete the 96-week double-blind treatment will have an option to~     enter a single group, active treatment open label extension, providing they fulfill the~     eligibility criteria.~   "
138104|NCT01247311|"~     Individuals with kidney disease have a high risk of heart disease. This is not related to~     traditional risk factors, such as high blood pressure, high cholesterol or being overweight.~     A lack of vitamin D could be the reason why blood vessels become damaged and could explain~     the link between heart disease and kidney disease.~   "
138105|NCT01247298|"~     This investigational study will evaluate if using a combination of TACE along with high dose~     SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.~   "
138106|NCT01247285|"~     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg~     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC~     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in~     healthy adult volunteers under non-fasting conditions.~   "
138107|NCT01247272|"~     This study compared the relative bioavailability (rate and extent of absorption) of 90 mg~     Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC~     WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in~     healthy adult volunteers under fasting conditions.~   "
138108|NCT01247259|"~     Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic~     rhinitis. It is often suggested that polysensitized patients might not benefit from specific~     immunotherapy as much as monosensitized patients, although further research on this subject~     is needed. This study compared the efficacy of SLIT with standardized house dust mite~     extract in mono- and polysensitized allergic rhinitis patients.~      Patients who were sensitized to house dust mites and treated with SLIT for house dust mites~     for at least 1 year between November 2007 and March 2010 were included. The mono-allergen~     sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides~     pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was~     defined as the patients who were simultaneously sensitized to house dust mites and other~     allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy.~     Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea,~     sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.~      This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups,~     while the change in the TNSS did not differ significantly between the groups. The~     anti-allergic medication scores also decreased significantly in both groups, but there was~     no significant difference between the groups.~      In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in~     both nasal symptoms and rescue medication scores to those in monosensitized patients,~     regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized~     allergic rhinitis patients.~   "
138109|NCT01247246|"~     This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial,~     initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be~     conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs)~     of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment~     period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and~     Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of~     approximately 12 months to determine if there is an effect of SCV 07 on the tumor response~     to ChemoRT.~   "
138167|NCT01246674|"~     By this study the investigators wish to (1) quantify hip strength and functional-performance~     deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if~     changes in thigh circumferences, or hip pain are correlated to changes in hip strength and~     functional-performance after fast-track THA.~   "
138110|NCT01247233|"~     The standard treatment for localized breast cancer is based on conservative surgery (when~     possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended~     total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to~     the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the~     difficulty for many patients to reach RT centers to receive standard whole breast~     irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time~     and several theoretical advantages over WBI, including a decrease in dose delivered to~     uninvolved portions of the breast and adjacent organs. If equivalence between the two~     treatments can be shown, then APBI will be considered as a historic evolution in breast~     cancer management.~      In this phase III trial, designed in postmenopausal women > 50 years of age, the objective~     is to compare the effectiveness and safety of APBI compared with whole breast irradiation.~     This study is also designed to ensure high quality criteria for surgery, pathology and RT~     techniques in the 3 arms and will allow to provide data on economics and costs.~   "
138111|NCT01247220|"~     Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab~     (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated~     with improved vision results. There is a subgroup of patients with peripheral nonperfusion~     on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.~      In this trial the investigators compare the gold standard of monthly ranibizumab injections~     with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography.~     Each group will have monthly injections for the first six months, then as needed by either~     visual acuity decrease or increased retinal thickness for the subsequent six months.~      The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence~     tomography, and number of ranibizumab injections~   "
138112|NCT01247207|"~     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is~     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining~     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads~     to weakness and loss of walking ability during childhood and teenage years. A specific type~     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in~     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense~     mutation. This study is an open-label trial for patients with nonsense mutation~     dystrophinopathy who received ataluren in a prior PTC-sponsored study at a US clinical trial~     site. This trial will be conducted at sites in the US and will evaluate the long-term safety~     of ataluren, as determined by adverse events and laboratory abnormalities.~   "
138113|NCT01247194|"~     The purpose of the study is to assess the safety, tolerability, antiviral effects, and~     pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.~   "
138114|NCT01247181|"~     The investigators hypothesize that sending weekly motivational text messages to people~     infected with HIV will encourage them to take their medication, compared to usual care.~   "
138115|NCT01247168|"~     This study is being conducted to test study drug AZD2461 to see how it may work to treat~     solid tumors. The main purpose of this study is to determine the safety and tolerability of~     AZD2461. This is the first time the drug has been given to humans and is classed as a first~     time in man study. Its main purpose is to establish a safe dosage of the drug and provide~     additional information on any potential side effects this drug may cause. The study will~     also assess the blood levels and action of AZD2461 in the body over a period of time and~     will indicate whether the drug has a therapeutic effect on solid tumors.~   "
138116|NCT01245751|"~     This study was conducted to obtain safety and immunogenicity data after a booster dose of~     Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was~     compared to similar information obtained after Zoster Vaccine, Live administration to~     age-matched and younger participants who received their first dose of Zoster Vaccine, Live.~     The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in~     participants ≥70 years of age induces an antibody response that is noninferior to that of a~     first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster~     dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster~     virus (VZV) antibodies.~   "
138117|NCT01245738|"~     The current study is proposed to investigate the pattern of dyslipidemia and of lipid~     treatment practices in patients in India experiencing their first acute cardiovascular event~     and the extent of residual dyslipidemia after 12 weeks of treatment with statins.~     Dyslipidemia definitions are per the National Cholesterol Education Program - Adult~     Treatment Panel III (NCEP-ATP III).~   "
138118|NCT01245725|"~     The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v.~     bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention~     (PCI) plus two hours after the procedure) is more effective than placebo in the setting of~     standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or~     bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac~     ischemic events defined as death, myocardial infarction (MI), and urgent target vessel~     revascularization (uTVR) within 48 hours following study drug initiation.~      A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus~     followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure)~     is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a~     thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as~     assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following~     study drug initiation.~      Patient enrollment is pending.~   "
138119|NCT01245712|"~     The goal of this clinical research study is to find out if receiving a 1-week course of~     partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe~     side effects (such as changes to the appearance of the breast) than a longer course of~     radiation treatment.~   "
138120|NCT01245699|"~     The investigators will quantify the quality of chest compressions provided in the Emergency~     Department and determine whether the quality of chest compressions is related to patient~     outcome. The quality of chest compressions and patient outcomes will be assessed both before~     and after the introduction of audiovisual feedback in real time.~   "
138121|NCT01245686|"~     Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of~     death in the US. Every year, more than one million Americans have a heart attack, and nearly~     800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more~     than $316 billion in health care and lost productivity.~      Both lifestyle changes and medication can reduce the risk of CVD, and this project combines~     these approaches in the hopes of identifying a practical intervention for use in primary~     care medical offices. The project combines two previously tested interventions and updates~     them to meet current guidelines for diet and use of aspirin and cholesterol-controlling~     drugs (statins).~      The research team is delivering the combined intervention in two formats: web-based and~     counselor-based. Each format has the same content, but the web-based advice is accessed~     through the Internet by clients at home, a community site, or a primary care office. The~     other format involves sessions delivered to clients by a counselor either in person at a~     primary care office or over the telephone. The researchers will compare how effective each~     format is in reducing participants' risk of coronary heart disease. They will also determine~     the interventions' effect on participants' diet, physical activity, smoking status,~     medication adherence, and other health indicators. In addition, the team will compare the~     two formats' cost-effectiveness and how well the patients, office staff, and clinicians~     accept the interventions.~      Recruited from five family practices, 600 patients representing the geographic and ethnic~     diversity of North Carolina are taking part in this study. Half the participants are~     randomly assigned to the web-based intervention; the other half to the counselor-based~     version. Both groups will also get information on local resources, such as gyms and farmers~     markets, that can help participants maintain a healthy lifestyle.~   "
138122|NCT01245673|"~     One purpose of this study is to find out if a new combination of immune system treatments~     (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection~     (immunity) against the myeloma cells. A second purpose is to find out how well this~     combination of immune system treatments is able to control the myeloma.~   "
138123|NCT01245660|"~     Modification of the EGF signalling pathway and / or HER 2, by Lapatinib in bladder cancer.~   "
138124|NCT01245647|"~     The purpose of the study is to find out if a medication,naltrexone is helpful for~     HIV-infected women who sometimes drink too much. The study will try to find out whether~     women like the medication, whether the medication helps them cut back on their drinking, and~     whether it helps improve their overall health. Naltrexone has not been used widely among~     people who are engaged in less severe drinking and in primary health care settings.~     Therefore, the investigators would like to determine whether it is helpful among women who~     sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The~     investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern~     will reduce their drinking which in turn will improve their medication adherence, improve~     their health and quality of life.~   "
138125|NCT01245634|"~     This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety~     of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing~     elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to~     receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32~     weeks.~   "
138126|NCT01245621|"~     ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care~     intervention designed to improve quality of life, mood, and symptom management for patients~     with an advanced stage cancer and their caregivers.~      The primary aims of this clinical trial are to determine whether a palliative care~     intervention (introduced immediately or 12 weeks after diagnosis) can improve survival,~     quality of life, mood, symptom intensity and end-of-life care.~   "
138127|NCT01245608|"~     The primary purpose of this study is to determine the effects of a fixed dose combination of~     valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of~     cardiovascular events in adults older than 50.~      Various liver-related variables will also be recorded which will allow studying the effects~     of PolyPill on the liver and the effect of liver diseases such as nonalcoholic~     steatohepatitis on cardiovascular events and the protective effect of PolyPill.~   "
138128|NCT01245595|"~     Children with congenital heart defects often need cardiac surgery with cardiopulmonary~     bypass (the heart-lung machine). Approximately 35 to 50% of these children will have~     acute kidney injury, or damage to the kidneys, after the procedure. We currently have few~     medications to prevent this kidney injury. The hypothesis of this study is that giving~     aminophylline after heart surgery can decrease the acute kidney injury.~   "
138129|NCT01245582|"~     Primary Objective:~      - To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to~     sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to~     prolong overall survival (OS) for advanced HCC patients.~      Secondary Objective:~        -  To compare the efficacy of SECOX regimen with Sorafenib alone for progression free~          survival (PFS)~        -  To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)~        -  To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone~   "
138130|NCT01247155|"~     The purpose of this randomized trial was to examine the value of the review on the first~     postoperative day after uneventful phacoemulsification cataract surgery.~   "
138131|NCT01247142|"~     The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive~     pulmonary aspergillosis in exhaled breath condensate.~   "
138132|NCT01247129|"~     The purpose of this study is to determine whether delaying the superficial inferior~     epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of~     its donor artery.~   "
138133|NCT01247116|"~     The purpose of this study is to evaluate the strategy of initiating double oral combination~     therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial~     hypertension (PAH) in a preliminary way.~   "
138134|NCT01247103|"~     The purpose of the study is to assess the safety, tolerability and pharmacokinetics of~     AZD4316 following oral administration of single and multiple doses to healthy volunteers.~   "
138168|NCT01246661|"~     The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to~     detect alcohol in breast milk that will be donated during this study. This research is being~     done because the sponsoring company, UpSpring, wants to determine if this test will work~     and, if it does, how well it will work to detect levels of alcohol in breast milk.~   "
138169|NCT01246648|"~     The etiopathogenesis of periodontal disease results from complex interaction between~     infectious agents, mainly including bacteria, and host cellular and humoral immune~     responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone~     to explain all biological and clinical features of the destructive periodontal disease. The~     main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well~     by altering epithelial gingival cell biology and consequently may promote the initiation and~     progression of periodontitis.~   "
138135|NCT01247090|"~     The death rate of patients with endstage renal disease (ESRD) on dialysis each year is 20%,~     with diseases related to the heart and blood vessels causing about half. About 60% of~     patients on hemodialysis have high blood pressure, which is poorly controlled in most.~     Normal blood pressure in these patients greatly improves the chance of living. Increased~     fluid in the body and bloodstream is a major cause of hypertension in patients with ESRD.~     Fluid removal during hemodialysis is often limited by symptoms of low blood pressure during~     the procedure. Therefore the increase in fluid and related high blood pressure is ongoing~     for many of these patients. Arginine vasopressin (AVP) is a hormone naturally produced by~     the body which has little effect on blood pressure in healthy people, but acts as a powerful~     vasoconstrictor (narrows the blood vessels) when blood pressure is threatened. Recent~     studies have shown when there is too little AVP, patients are more likely to have low blood~     pressure during dialysis that limits fluid removal, an effect that can be reversed by giving~     these patients low doses of AVP. This phase II trial will find out which of two doses of AVP~     (.15 or .30 mU kg-1 min-1), in combination with standard therapy, works best to change~     interdialytic 44-hour ambulatory systolic blood pressure after 2 weeks. Patients who enroll~     in this study will be divided into three groups. One group will be given a 0.15 mU kg-1~     min-1 dose of AVP at each dialysis session over a 2-week period; the second group will be~     given AVP 0.3 mU kg-1 min-1 at the same interval; and a third group will be given normal~     saline (placebo) at the same interval. All patients will be closely monitored for~     side-effects.~   "
138136|NCT01247077|"~     Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from~     weight loss, increased heart rate and stress intolerance. Some patients have difficulties in~     regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin,~     suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory~     antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in~     western Europe. This compound has important function in thyroid hormone metabolism and on~     the immune system. It is not known whether addition of selenium affects the well being of~     patients with Graves´thyrotoxicosis. The subject of this study is to investigate this~   "
138137|NCT01247064|"~     The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS)~     improves respiratory distress in children 2-23 months presenting to the emergency department~     (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy~     with a trial of nebulized albuterol.~   "
138138|NCT01247051|"~     The study is a single-center, randomized, un-blinded treatment study in which patients (>78~     years) with the use off a heart-lung machine were provided into two study arms.~      Patient wit precoating have a filling of the machine with their own blood. In the~     comparator arm, a standard priming is used.~   "
138139|NCT01247038|"~     The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal~     articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal~     articulation using the same cup in regards to the composite clinical success (CCS) rate at 2~     years postoperatively (delta = 10% minimum clinically significant difference in rates).~   "
138140|NCT01247025|"~     The primary research question in this study will ask, among those receiving outpatient~     mental health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver~     Veterans Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)?~     Here, it is hypothesized that PGD will occur within the sample. A secondary aim of this~     study will be to investigate how often PGD co-occurs with posttraumatic stress disorder~     (PTSD) and/or depression. Also, while PGD has been shown to have an effect on self-directed~     violence (SDV) among civilians (Prigerson, Bridge et al., 1999), no studies yet have~     examined the relationship between PGD and SDV among Veterans. Therefore, it also is~     hypothesized that as PGD severity increases among the Veteran sample, risk for SDV will~     increase as well. Additional research aims also will be addressed in this study. For one, it~     will be assessed which grief symptoms are most often reported among the Veteran sample.~     Also, no study has yet to examine if there are neuropsychological differences between PGD~     and PTSD. Therefore, another research question here is whether PGD indeed is~     neuropsychologically different from PTSD. Here, the exploratory hypothesis is that PGD~     sufferers will respond to a measure of multiple components of cognition (e.g., planning,~     sequencing, concentration, multitasking, and memory efficiency) in a manner that is~     significantly different from PTSD sufferers.~   "
138141|NCT01247012|"~     Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver~     disease (PNALD). The purpose of this study is to determine the effect of treatment with a~     smaller amount lipid minimization) of our standard soybean oil based intravenous lipid~     emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with~     severe cholestasis.~   "
138142|NCT01246999|"~     A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose~     schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or~     licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV~     followed by TIV separated by 28 days. Children with a laboratory documented history of prior~     H1N1 infection will be excluded.~   "
138143|NCT01246986|"~     The purpose of this study is to estimate the median time to progression in participants with~     hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination~     with sorafenib or ramucirumab.~   "
138144|NCT01246973|"~     The purpose of the study is to determine whether curcumin, an ingredient of some foods, can~     prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy.~     Dermatitis is a common side effect of radiation treatment, but few effective treatments have~     been developed for it. Curcumin is a natural compound found in both turmeric and curry~     powder. It has been used for centuries as a spice (curry), a food coloring and as a food~     preservative. Curcumin is non-toxic and has been found to enhance the functions of normal~     tissues..~   "
138145|NCT01246960|"~     The purpose of this study is to determine whether ramucirumab when used in conjunction with~     chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal~     cancer.~   "
138170|NCT01246635|"~     The purpose of this clinical study is to demonstrate the effectiveness and safety of the~     Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects~     of the knee compared to Microfracture.~   "
138146|NCT01246947|"~     The mitral valve is the inflow valve into the main pumping chamber of the heart. It can~     become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When~     patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either~     fix or replace the valve. Many patients with mitral valve disease also develop a leaky~     tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart~     (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid~     valve is determined by an ultrasound test, and the amount of leakiness is graded as: none,~     mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral~     valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This~     involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid~     valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at~     the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are~     uncertain about what to do. In a recent review of thousands of patients across the nation~     having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had~     tricuspid valve repair. Since the investigators don't know what the best approach is: to~     leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the~     investigators propose a study to determine which approach is best. Patients having mitral~     valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a~     tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will~     carefully follow these patients for two years and see if heart function is better among~     those who got their valve fixed.~   "
138147|NCT01246934|"~     In this study the investigators are presenting the advantages as well as the disadvantages~     of ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.~   "
138148|NCT01246921|"~     Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised~     by the development of depigmented macules. It develops probably due to immunedestruction of~     melanocytes. Most effective therapies are immunsuppresive:~        1. local immunesuppressives like corticosteroids and calcineurin inhibitors~        2. phototherapy like PUVA and NB-UVB phototherapy. NB-UVB is the first choice A~          synergistic effect of UVA and topical corticosteroids (fluticasone proprionate 0.05%~          cream) has been described by Westerhof et al. in 1999. To our knowledge to date there~          are no publications comparing NB-UVB combined with a topical corticosteroid and NB-UVB~          alone.~      Objective: The objective of this study is to evaluate the clinical effects (onset and degree~     of repigmentation) of fluticasone proprionate 0.05% cream (thrice weekly) on NB-UVB~     phototherapy twice weekly for a period of 12 months.~      Study design: Prospective single blinded randomised controlled study. Study population:~     Consecutive patients ≥ 18 years, diagnosed with active vitiligo vulgaris who will receive~     NB-UVB phototherapeutic treatment at the Netherlands Institute for Pigment Disorders at the~     Academic Medical Centre (AMC), University of Amsterdam.~      Methods: The patient will be randomised for either NB-UVB phototherapy and fluticasone~     proprionate 0.05% cream or NB-UVB phototherapy alone for 12 consecutive months.~      Main study parameters/endpoints: The onset and degree of repigmentation is assessed by~     digital image analysis of a target lesion and blinded global physician assessment.~     Furthermore, the patients and doctors satisfaction will be assessed and changes of~     immunohistochemical parameters will be analysed in skin biopsies.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects participating in the study will be asked to visit the institute 4~     times. The time investment will be 20 minutes per visit. Additionally, patients will be~     asked for consent to take punch biopsies (3 mm) at the beginning and at the end of the~     treatment period. Hence, skin biopsies are not compulsory for participation in this study.~     Patients may chose to participate in the clinical non invasive part of the study. Known side~     effects of the NB-UVB phototherapy are redness, pruritus, xerosis cutis, burning sensation~     and conjunctivitis. These side-effects however, are largely dose-dependent and avoidable.~     Corticosteroid associated systemic side-effects (suppression of the adrenocortex) will be~     minimized by treating only a limited body surface [a maximum of 30% body surface] and by~     using an intermittent application scheme of three days a week in the long term treatment.~     The regions which are known to have a higher absorption are excluded (periorbital, axillary,~     inguinal and genital area). Both topical corticosteroids and NB-UVB are part of the Dutch~     and British guidelines for the treatment of vitiligo. There is no presumptive evidence or~     indication that the combination of these therapies may result in a higher risk of side~     effects.~      All together the burden due to the study is low and the risk for systemic or local side~     effects is low.~   "
138149|NCT01246908|"~     The purpose of this study is to determine if CX157 is effective and safe in patients with~     treatment of treatment resistant depression over six weeks of treatment.~   "
138150|NCT01246895|"~     This follow-up study will evaluate the effects of BST-CarGel® application to a~     microfractured lesion (investigational) and microfracture alone (control) for up to 5 years~     from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will~     serve as a post approval study for these Protocols, in support of a commercial application.~     The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of~     articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial~     and lateral femoral condyles of the knee, and were classified as either acute or chronic.~   "
138151|NCT01246882|"~     The purpose of this study is to determine the effects of daily feedback about physical~     activity (number of bouts of walking, duration of bouts, total walking distance, average and~     fastest walking speed) and walking average speed compared to feedback about walking speed~     only on walking-related outcomes during inpatient rehabilitation for stroke. For the first~     time, daily walking and other exercise will be monitored by bilateral triaxial~     accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient~     sensor data and return a summary to the participants at each site.~   "
138152|NCT01246869|"~     Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole)~     in patients with (1) newly diagnosed primary malignant brain tumors (WHO [World Health~     Organization] Grade III or IV glial-based tumors) who have not had a complete surgical~     resection and by contrast MRI (Magnetic resonance imaging) have residual tumor > 1.0 cm in~     diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (> 1.0~     cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor~     hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change~     patient management once validated as tumor hypoxia is known to be associated with a poor~     prognosis [Eyler 2008].~   "
138153|NCT01246856|"~     Many patients with breastcancer in the past, were treated with TAC. These last years, there~     is more and more focus on the effects of chemotherapy, particularly in children treated with~     this. One of these effects is damage to the heart muscle, which ultimately might affect the~     pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has~     not been previously investigated. The possibility exists that the adverse reactions in~     children are found in adults also could occur. Therefore we have initiated this trial.~   "
138154|NCT01246843|"~     Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a~     tumor of the intestines) may be eligible for treatment with one of the following drugs:~     sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in~     cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators~     knowledge on the effects and side effects of these two medicines, in the University Medical~     Center St. Radboud lot of research is done. This study is a part of that.~      Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less~     able to concentrate, that their memory is not working properly or that they are less able to~     imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In~     how many of the patients this occurs, how severe the symptoms are and how it is caused, is~     still unknown.~      The goal of this research is to examine how memory, concentration and knowledge processing~     works in patients using sorafenib or sunitinib. With the research the investigators hope to~     get answers to the following questions:~        1. How common are problems with memory, concentration and processing of knowledge in~          patients receiving the drug sunitinib or sorafenib?~        2. What are the problems of memory, concentration and processing of knowledge in the use~          of sunitinib or sorafenib?~        3. What could be the cause of the problems that patients experience from memory,~          concentration and processing of knowledge in the use of sunitinib or sorafenib?~        4. Is there a link between problems with memory, concentration and processing of knowledge~          and also experiences of fatigue or mood of a patient?~   "
138171|NCT01246622|"~     This phase I trial is studying the side effects and best dose of lenalidomide when given~     together with cytarabine in treating patients with relapsed or refractory acute myeloid~     leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system~     in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may~     kill more cancer cells~   "
138155|NCT01246830|"~     Research questions:~        1. Will the panoramic images derived from cone beam CT data give better diagnostic ability~          than conventional panoramic radiographs?~        2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information~          for treatment planning?~        3. Will the 3D cephalometric analysis give more accurate treatment plan and better~          treatment outcome?~      General hypothesis and special aims~      Overall aims:~        -  To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic~          outcome.~        -  To determine the accuracy and diagnostic ability and usability of the 3D cephalometric~          analysis.~        -  To evaluate the diagnostic ability and usability of the panoramic image derived from~          cone beam CT data as compared to 2D panoramic images.~        -  To evaluate the value of the cone beam CT data in cephalometric analysing process for~          orthodontic and maxillofacial surgery treatment.~      Hypotheses:~        1. The availability of the 3D cephalometric analysis influences the orthodontic and~          maxillofacial treatment plan and decision, and might change the treatment outcome.~        2. Panoramic images derived from cone beam CT data may provide equal information for~          diagnosis as conventional panoramic images.~        3. Cone beam CT will be able to replace classic orthodontic imaging being more time and~          dose efficient and having a beneficial effect on treatment outcome.~   "
138156|NCT01246817|"~     This study uses one trialdrug: Temsirolimus (sometimes called Torisel ® ). Temsirolimus is~     an mTOR inhibitor. It is an agent that is specifically aimed at disrupting cell division~     (needed for cancer cell growth). Temsirolimus has been shown to inhibit the growth of cancer~     cells. For patients with metastatic kidney cancer Temsirolimus is now a registered ,~     conventional therapy. It has been recorded for patients as they get renal cell cancer~     metastases and which looks as if the tumor is aggressive.~      This is a phase II trial. This means that the investigators look at how effectively~     temsirolimus is, after treatment with other drugs against kidney cancer. Effective means~     that the investigators see how well the treatment is, the investigators look at how long the~     disease is not growing and if it does, that is smaller. The possible side effects will be~     carefully watched.~   "
138157|NCT01246804|"~     The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the~     pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety~     profile of the combination is studied.~   "
138158|NCT01246791|"~     The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and~     ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.~      Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of~     AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.~   "
138159|NCT01246778|"~     Rationale:~      Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic~     renal carcinoma and gastrointestinal stroma tumors) has been associated with development of~     heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators~     hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance~     against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin~     and AICAR reverse this unwanted effect of sunitinib.~      Objectives:~      The primary objective of the study is to investigate the effect of sunitinib on ex-vivo~     atrial contractile force in absence and presence of ischemia-reperfusion.~      A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced~     deterioration of contractile function of human atrial trabeculas. Study design: Lab~   "
138160|NCT01246765|"~     The purpose of the National Pregnancy Registry for Atypical Antipsychotics is to determine~     the frequency of birth defects among infants exposed to atypical antipsychotics.~   "
138161|NCT01246752|"~     Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of~     age in intermediate risk, after first complete response in comparison to standard~     consolidation chemotherapy~   "
138162|NCT01246739|"~     Incidental findings of adrenal tumours,incidentalomas, occur in 1-5 % in the general~     population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism.~     Although the patients do not have clinical signs of classical Cushing's syndrome, they have~     an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and~     obesity.~      The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the~     increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome.~   "
138163|NCT01246726|"~     This is a pilot study comparing the appearance and volume of the post surgical region in the~     intact breast, as determined by 3 modalities: computed Xray tomography (CT), 3 Dimensional~     ultrasound (USS), Magnetic resonance imaging (MRI) after breast conserving surgery and~     during whole breast irradiation.~   "
138164|NCT01246713|"~     The purpose of this study is to determine whether excipients in the liquid formulation of~     acetaminophen prevent the formation of the toxic metabolites of acetaminophen.~   "
138165|NCT01246700|"~     The purpose of this study is 1.) to determine if sensory attention focused exercise is an~     effective management strategy for Parkinson's disease, and 2.) to identify if the benefits~     are a result of strength gains.~   "
138166|NCT01246687|"~     Introduction: The Internet holds promise for a wide-scale promotion of dietary and lifestyle~     behavioural change. Website-delivered interventions have a potentially broad population~     reach as it is available 24 hours, and could be hosted by both government and~     non-governmental agencies. To date, there is no published study focused on dietary behaviour~     change in adults with Type 2 Diabetes Mellitus (T2DM) via a website-based system.~      Objective: To improve nutrition knowledge, attitude and behaviour (KAB) of the patients with~     T2DM through a 6-month dietary education programme delivered via a website. The secondary~     objectives of this study are to improve the participant's selected anthropometric~     measurements, dietary practices and biomarkers.~      Hypothesis: A 6-month web-based dietary education programme will improve diabetic patients'~     nutrition KAB.~      Methods: This is a two-armed matched-design randomized controlled trial (RCT) scheduled for~     two years in three public hospitals in Klang Valley. It will be carried out with~     quantitative techniques to measure the primary and secondary outcomes. Permission from~     relevant authorities has been obtained for this purpose. The targeted sample size is 100~     subjects, with 50 subjects in each arm. The intervention group will be required to~     participate in a 6-month web-based dietary intervention, while the control group will~     receive the usual care given to diabetic patients. The subjects will then be followed up for~     another 6 months. Data collection will be held at baseline, 6-month and 12-month.~      Expected results: The dietary recommendations are personalised according to the Stages of~     Change (SOC) the patient is in. The improvements in knowledge and attitude, and progress in~     SOC are expected to be reflected in the patients' dietary behaviour. Adoption of healthy~     dietary practices then is expected to be reflected on the anthropometric measurements and~     biomarkers. In the long run, the findings are expected to assist promotion of healthy diet~     and lifestyle to high-risk groups as well as Malaysian public in line with technology~     development. Moreover, the output from this research may serve as recommendation to Ministry~     of Health and other related NGOs on effective dietary intervention strategies for prevention~     of T2DM and complications which arise from the disease in this country.~   "
138172|NCT01246609|"~     Background:~      There are several surgical procedures in which irrigation fluids are used to enable vision~     and treatment in body cavities, such as hysteroscopy, arthroscopy and cystoscopy. Several~     solutions are used for irrigation: normal saline, glycin, mannitol, sorbitol and others.~     Post-operative complications, as visual disturbances, confusion and other neurologic~     symptoms were attributed to irrigation fluid absorption, water intoxication and~     hyponatremia, and are refered to as TURP syndrome when appearing following transurethral~     prostatectomy (TURP). Historically, a reduced serum sodium concentration has been used to~     diagnose absorption of electrolytes-free irrigating fluid during urologic procedures.~     However, neurologic symptoms following transurethral prostatectomy (TURP) do not correlate~     with blood sodium level, moreover, Hyponatremia may not be the sole or even the primary~     cause of the neurological manifestations of TURP syndrome. Other techniques were suggested~     for evaluating the volume of irrigation solution absorption though none is used routinely in~     the clinical setting.~      Percutaneous Lithotripsy (PCNL) is a procedure used to treat patients with nephrolithiasis.~     In this procedure irrigation fluid is administered into the kidney and urinary tract~     collecting system. The solution used is normal saline. In earlier studies there was no~     evidence for absorption of the irrigation fluids, though medical literature on this issue is~     limited. However, minute changes in electrolytes and acid-base balance may indicate the~     opposite is true. Indeed, the volume of irrigation and duration of the procedure may have an~     effect as well. According to the investigators hypothesis, the change in Ph and reduction in~     base content in patients undergoing PCNL may be the result of irrigation fluid absorption,~     since chloride from the normal saline is known to cause such effect.~      Methods This is an observational prospective study of consecutive 200 adult patients~     undergoing elective surgery of PCNL in the investigators operating rooms.~      The investigators will collect data that is taken from the patient's file and routine~     management of these patients: age, gender, weight, pre-operative blood tests including:~     electrolytes, creatinine, hematocrit, ph, bicarbonate, base, length of the procedure, volume~     and type of irrigation fluids used, volume and type of intravenous fluids used.~     Post-operative blood tests will be recorded.~      The investigators will compare pre and post-operative blood tests, especially ph,~     bicarbonate, base content, sodium. The investigators will analyse statistically the~     correlation between the change of each parameter (delta X) and the volume of irrigation~     fluids used during the surgery.~   "
138173|NCT01246596|"~     The etiopathogenesis of periodontal disease results from complex interaction between~     infectious agents, mainly including bacteria, and host cellular and humoral immune~     responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone~     to explain all biological and clinical features of the destructive periodontal disease. The~     main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well~     by altering epithelial gingival cell biology and consequently may promote the initiation and~     progression of periodontitis.~   "
138174|NCT01246583|"~     The study is being conducted to see whether CP-690,550 ointment has potential as a safe and~     effective treatment for adult patients with mild to moderate chronic plaque psoriasis.~   "
138175|NCT01246570|"~     It is known that organized cardiac rehabilitation is effective in improving exercise~     capacity in coronary heart disease patients. Less is known about the long-term results after~     cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when~     no longer attending formal rehabilitation. The investigators wish to investigate the effect~     of a maintenance program after ending a rehabilitation program, and to compare this to usual~     care. The investigators hypothesis is that the maintenance program will result in higher~     exercise capacity and more physical activity compared to usual care.~   "
138176|NCT01246557|"~     Despite certain notable progress, treatment of patients with Chronic Lymphatic Leukemia~     (CLL) is still disappointing. Although thanks to the use of treatment of (immune)~     chemotherapy, mainly based on fludarabine, rituximab and alemtuzumab, the rate of complete~     response (CR) has increased from minus 10% observed when clorambucil was the core of the~     therapy to a 60-70%, with time all patients relapse and most of them die at the end due to~     the disease or to involvements related to the treatment. Progress when understanding the CLL~     biology have cleared a series of aspects: 1) there is a significant proportion of CLL cells~     actively copying themselves, contrary to the opinion that most of CLL cells are in G0 phase~     of the cell cycle; 2) Immune regulatory mechanism basically measured by T cells and NK cells~     have an important role in the continuous accumulation of CLL cells in the body; 3) Cells of~     the stroma are essential to maintain survival of CLL cells through a series of cytokines or~     chemokines. Under the light of this evidence, it is worth studying new treatment modes~     directed not only to CLL cells but also to the microenvironment and immune functions.~      Lenalidomide is being investigated as treatment for several oncologic indications including~     myelodysplastic syndromes, multiple myeloma and non-Hodgkin lymphoma. Within the scope of~     CLL, it has been proved that lenalidomide is active in patients with relapsing / treatment~     resistant CLL patients. Forty five patients with relapsing CLL, 51% resistant to~     fludarabine, where included in a phase II study and were treated orally with 25 mg of~     lenalidomide on days 1 to 21 of a cycle of 28 days. The total response rate was of 47% with~     up to a 9% of complete responses.~      The combination of lenalidomide with dexamethasone is being investigated in multiple myeloma~     and has revealed as a highly efficient treatment in relapsing/ treatment resistant patients~     as well as in those newly diagnosed. Bearing in mind that both drugs, lenalidomide and~     dexamethasone, are clinically active in CLL the investigators have designed a study with~     this combination in relapsing or treatment resistant patients following treatments~     containing fludarabine which do not meet the requirements for an intensive rescue treatment.~      Given initial doses of 10 and 25 mg of lenalidomide daily may be associated with tumor lysis~     cases, it is proposed a low initial dose of lenalidomide in the first cycle 2.5mg., with~     further increases to prevent the occurrence of tumor lysis syndrome~   "
138177|NCT01246544|"~     In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the~     investigators would like to ask medical colleagues in the region to participate in an~     anonymous German online survey on patient safety.~      The investigators want to investigate the implementation and establishment of measures on~     patient safety, that anaesthesiologists utilize to fulfill their obligations.~   "
138178|NCT01246531|"~     Urinary lithiasis is a common disease on young adults, but not so far on aging people.~     Nowadays, the investigators are seeing a gradative growth on men above sixty years old,~     mainly in industrialized countries. The purpose of this study is to investigate metabolic~     aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples,~     imagenological exams and bone densitometry. The investigators have made a case-control~     model.~   "
138179|NCT01246518|"~     Onychomycosis is a fungal infection that affects fingernails and/or toenails.~      The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of~     patients with fungal infection of the toenails.~   "
138180|NCT01246505|"~     Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the~     lower extremities.~   "
138181|NCT01246492|"~     The purpose of this study is to determine whether the presece of the artificial sweeteners~     aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally~     incested glucose solution.~   "
138182|NCT01246479|"~     The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a~     pediatric population vaccinated in the parent study IC51-322.~   "
138183|NCT01246466|"~     The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac~     surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in~     treating AF, and how effective this combined procedure is using the AtriCure System in~     treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac~     surgery and a standard electrophysiology catheter, currently available, will be used to~     perform the catheter ablation procedure. This surgical procedure is considered less invasive~     because it is done through tiny surgical punctures on the sides of the chest near the ribs~     instead of one large surgical incision of the breast bone to completely open the chest and~     access the heart, and it also avoids the need for the heart-lung bypass machine.~   "
138184|NCT01246453|"~     1. Objectives:~             -  Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs~               urokinase in patients with complex complicated parapneumonic pleural effusion and~               empyema.~             -  To evaluate the pleural and plasmatic levels of the fibrinolytic system markers~               after the treatment with alteplase vs urokinase~             -  To evaluate the safety of alteplase in the treatment of complex complicated~               parapneumonic pleural effusion and empyema~        2. Design: Multicentric, randomized, parallel, controlled and double blind~        3. Main variable: Percentage of curation~        4. Study population and number of patients: 204 patients with complex complicated~          parapneumonic pleural effusions and empyema~        5. Duration of the treatment: Three days (main variable), and optional three days~          (secondary variable)~   "
138185|NCT01246440|"~     The purpose of this study is to evaluate the efficacy and safety of catumaxomab as~     consolidation treatment in patients with epithelial ovarian cancer in second or third~     complete remission.~   "
138186|NCT01246427|"~     The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in~     reducing hot flash scores after 4 weeks of treatment.~   "
138187|NCT01246414|"~     This study aims to compare the inflammatory mediators in exhaled breathe condensates from~     allergic and non-allergic asthmatic patients.~   "
138188|NCT01246401|"~     Specific Aim: To conduct a randomized, placebo-controlled trial of extended~     release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners~     meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are~     transitioning from the structure of a correctional setting to the community.~      Hypotheses:~      i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1~     RNA levels, higher CD4 counts and higher rates of retention in care.~      ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to~     opioid relapse, lower addiction severity and lower craving for opioid.~      iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the~     control group.~      iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to~     the community.~   "
138189|NCT01246388|"~     The purpose of this study is to evaluate non-invasive parameters for staging and grading of~     chronic hepatopathy in comparison to liver biopsy.~   "
138190|NCT01246375|"~     The purpose of this research is to determine whether the prevalence of osteoporosis is~     greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma~     disease and uses inhaled steroids.~   "
138191|NCT01246362|"~     The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing~     post-operative pain and improving function outcome after a total knee arthroplasty.~   "
138192|NCT01246349|"~     The investigators studied the effect of motivational interviewing (MI) on self-efficacy,~     health behaviors, and health outcomes in overweight children and adolescents (ages ranging~     from 10 to 18 years).~   "
138193|NCT01246336|"~     Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis~     and differential diagnosis are not yet available. Exhaled breath testing may yield a~     breath-print that can be used to distinguish healthy and diseased states.~   "
138194|NCT01246323|"~     The purpose of this study is to determine whether combined anesthesia will provide better~     pain control for the postoperative period following gynecological laparoscopy surgery.~   "
138195|NCT01246310|"~     Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting~     5-10% of women of reproductive age. Beside impairments on reproductive functions~     (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes~     mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating~     disorders). Recently, several studies have shown that there is an increased risk of mood~     disorders in women with PCOS, with major depression and bipolar disorder as the most~     frequent diagnosis.~      Myo-inositol is classified as a member of the vitamin B complex and it works as a second~     messenger system of several neurotransmitter receptors; furthermore, inositol, when~     administrated at pharmacological doses, crosses the blood-brain barrier.~      Studies from the 90s showed that inositol, alone or in combination with other antidepressant~     drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the Hamilton~     depression rating Scale.~      Recently, inositol has been proposed as treatment to improve clinical, metabolic and~     endocrinal status in PCOS patients. Administration of myo-inositol to PCOs patients resulted~     in several beneficial effects, such as decrease of circulating insulin and serum total~     testosterone as well as a restored ovulation.~      In this proposed study, the investigators aim to evaluate in a double blind randomized trial~     whether inositol alone has beneficial effects on mental health disorders associated with~     PCOs. In particular, 60 women in reproductive age that will be diagnosed of PCOs, according~     to Rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or~     placebo group. Both groups will go through ultrasonic evaluation of the ovaries and serum~     hormonal levels (FSH, LH, testosterone, estradiol and insulin) will be evaluated.~     Furthermore, with the help of psychiatrics, patients will be interviewed in order to test~     the presence of any mental health disorders using validated tests such as: Hamilton Anxiety~     Scale (HAM-A), Hamilton Rating Scale for Depression (HAM-D), Health Assessment Questionnaire~     (HAQ), Short Form of Mc Gill Pain Questionnaire (SF-MPQ).~      Women assigned to the inositol group will receive 12g of inositol during the day in three~     different administrations for a period of 4weeks.~      At the end of treatment period patients will be interviewed by psychiatrics and will go~     through ultrasonic evaluation of the ovaries and hormonal levels will be tested~   "
138196|NCT01246297|"~     Patients who have surgery to cure lung cancer often have multiple problems at hospital~     discharge and later on. This includes poor exercise performance and quality of life,~     breathlessness, pain and tiredness. Currently there is little formal physical or~     psychological support for such patients. This pilot study aims to investigate whether~     outpatient pulmonary rehabilitation (an exercise training and education programme), started~     within 2 weeks of hospital discharge, can lead to improvements in exercise performance and~     quality of life in patients who have undergone lung cancer surgery. The study will also~     assess whether pulmonary rehabilitation is acceptable for patients and will analyze the~     safety profile. The hypothesis is that patients; discharged from hospital after undergoing~     lung cancer surgery, have improved exercise performance and quality of life following early~     outpatient pulmonary rehabilitation compared with usual care.~   "
138197|NCT01246284|"~     Alopecia areata (AA) is a disease characterized by areas of hair loss. Localized steroid~     injections is the standard treatment for limited disease. There are no existing studies that~     compare different concentrations of steroids in the treatment of AA. This study will compare~     the efficacy and safety of different concentrations of localized steroid injections in the~     treatment of AA. Six treatment sessions will be done over 6 to 9 months. The investigators~     will compare the following concentrations: 2,5mg/ml, 5mg/ml, 10mg/ml, and normal saline.~   "
138198|NCT01246271|"~     There is a concern about choosing adequate surgical options for stress urinary incontinence~     associated with vaginal prolapsed and still lack of evidence can be observed. In this study~     we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic~     organ prolapsed.~   "
138200|NCT01245569|"~     The purpose of the present study is to determine the effects on health status and~     spirometric values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one~     inhalation b.i.d.), over a 12-week treatment period in Chronic Obstructive Pulmonary Disease~     (COPD) patients.~   "
138201|NCT01245556|"~     The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in~     combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when~     administered in combination with ipilimumab.~   "
138202|NCT01245543|"~     AC480IV will be administered as a monotherapy and then in combination with docetaxel in~     patients with locally advanced or metastatic solid tumors for whom there are no standard or~     curative therapies available. It is designed to evaluate the safety and pharmacokinetic~     parameters of AC480IV as monotherapy and also in combination with docetaxel under the~     conditions of the study.~   "
138203|NCT01245530|"~     The purpose of this study is to evaluate the efficacy and safety of two fixed dose~     (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil~     for treatment for patients with Alzheimer type dementia.~   "
138204|NCT01246245|"~     The incidence of pin site infection is related to the nursing management of external~     fixation.~   "
138205|NCT01246232|"~     Schizophrenia is a mental health problem usually starting in the late teens/early twenties,~     and often lasting many years. The standard medication ('antipsychotics') for this problem is~     usually helpful, and if taken continually can keep people well, reducing the likelihood of~     further episodes. However, in up to one in three people with schizophrenia, the illness does~     not show much improvement with antipsychotic medication. For some of these 'resistant'~     illnesses, one particular antipsychotic, clozapine, can work well, but one disadvantage is~     the risk of a severe blood side effect which means that regular blood testing is necessary.~     If the response to clozapine treatment is disappointing, there is some evidence that adding~     another antipsychotic can sometimes produce more improvement. However, it seems that the~     added antipsychotic may need to be taken by the person for at least 10 weeks in order to~     work well. The investigators plan to test carefully the possible benefits and problems when~     the antipsychotic amisulpride or a dummy tablet ('placebo') is added to clozapine for 12~     weeks in people whose schizophrenia illness has not been helped much by any antipsychotic~     medication on its own, and who are now taking clozapine, but again with not much~     improvement. The investigators have chosen amisulpride because its pharmacological action~     may be complementary to that of clozapine, and also it is less likely than some other~     antipsychotics to compound some of the characteristic side effects of clozapine, such as~     sedation, weight gain and other metabolic problems.~      Adjunctive amisulpride or placebo will be randomly assigned. The investigators expect that~     adding amisulpride will be more likely to cause an improvement than adding placebo. But the~     investigators should learn more about the risks and side effects of combining these two~     medications. Also, the investigators should gain a greater understanding of the possible~     benefits of adding another antipsychotic to clozapine in relation to particular problem~     symptoms, and a person's ability to live and work in the community.~   "
138206|NCT01246219|"~     The research aims to provide data on gender-related psychological impact of GH (Growth~     Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males~     are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the~     study, the investigators aim to provide descriptive documentation of the unique distress~     signal manifestation implicitly shown by ISS (idiopathic short stature)boys and suggest~     methods of early detection and measurement of such manifestations that can be used to cement~     guidelines for the treatment in GH.~   "
138207|NCT01246206|"~     The primary goal of the study is to determine the incidence and severity of acute Graft~     versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor~     Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive~     the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also~     will determine the safety of this combination in the first six months post transplant.~      Secondary goals include determining the time to recovery of white blood cells and platelets~     (engraftment), determining the occurrence of opportunistic infections, defined as infection~     that occurs in people with weakened immune systems and caused by organisms that do not~     normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral~     infections), estimating the incidence of chronic GVHD at two years and the overall and~     disease free survival at two years.~      Immune response will be assessed by means of immuno-correlative studies both prior to and at~     various points after transplant.~   "
138208|NCT01246193|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics of~     CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.~   "
138209|NCT01246180|"~     Pressure ulcers are a common and costly problem. Advancing the understanding regarding the~     basic pathophysiological mechanisms mediating the development of pressure ulcers will allow~     for better delineation of populations at risk.~      Healthy skin is protected from pressure-induced ischemic damage because of the presence of~     pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic~     patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous~     ischemia, which could lead to pressure ulcer formation.~      Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous~     mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments~     that block ASICs.~   "
138210|NCT01246167|"~     This trial is designed to compare head-to-head conservative with operative treatment in 2~     stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and~     operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented~     fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative~     treatment, operative treatment with Philos plate and operative treatment with Epoca~     prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for~     specific treatment of different age and fracture groups. A cost-effectiveness analysis and~     comparison between different treatment modalities will be carried out. The primary outcome~     measure will be the DASH score and the secondary outcome measure the EQ-5D value.~     Recruitment period is 3 years and follow-up 2 years.~   "
138211|NCT01246154|"~     To evaluate exercise tolerance.~   "
138212|NCT01246141|"~     Functional tricuspid regurgitation is common in patients with heart valve disease,~     replacement and repair both can correct this anomaly. However, there is no data to address~     which one can bring more benefits to these patients with combined heart valve disease. The~     investigators retrospectively review patients with two or more heart valve disease and~     functional tricuspid regurgitation, and assess its long term outcomes.~   "
138225|NCT01245959|"~     The purpose of this study is to compare induction chemotherapy~     (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent~     chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC),~     in order to confirm the value of induction chemotherapy in NPC patients.~   "
138213|NCT01246128|"~     Background:~      - Previous studies have suggested that smoking cigarettes affects the number of receptors in~     the brain for nicotine, a chemical present in cigarette smoke. The receptors play a role in~     an individual's ability to think and concentrate. Many people with schizophrenia and similar~     disorders smoke, and research suggests that smoking may temporarily improve concentration~     and focus in individuals with schizophrenia. Researchers are interested in studying both~     current smokers and nonsmokers with schizophrenia to determine whether smoking affects the~     number of nicotine receptors in the brains of people with schizophrenia.~      Objectives:~      - To study the distribution and volume of nicotine receptors in the brains of individuals~     with schizophrenia who are either nonsmokers or current smokers.~      Eligibility:~        -  Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia~          and are either nonsmokers or current smokers (at least 10 cigarettes per day for the~          past year).~        -  Current smokers must be able to give up smoking for 48 hours.~      Design:~        -  This study involves an initial screening visit and up to five study visits.~        -  After the screening visit, participants will have two sessions in which they will~          complete questionnaires about thoughts, memory, and smoking habits. Smokers will also~          have nicotine blood and carbon monoxide breath levels taken during these sessions,~          before and after smoking a cigarette.~        -  Participants will have sessions with imaging studies (e.g., magnetic resonance imaging)~          to provide baseline measurements for later tests, and will also have tests to measure~          brain electrical activity.~        -  Participants will have a positron emission tomography (PET) scanning session to examine~          the nicotine receptors in the brain. Participants will need to stay overnight~          (nonsmokers) or for 2 nights (smokers) as an inpatient before the session. The PET scan~          session will take up to 6 hours, although participants will only be in the scanner for~          up to 3 hours.~        -  Participants will have a follow-up phone call with study researchers 1 week after the~          PET scanning session.~   "
138214|NCT01246102|"~     Background:~      - The experimental drug AT13387 has been shown to have some anticancer effects against tumor~     cells by blocking a protein that affects other proteins inside certain cancer cells, and~     helps to prevent the cancer cells from reproducing and spreading. AT13387 has not been~     tested in humans, and researchers are interested in investigating whether it can be used to~     treat solid tumors that have not responded to standard treatments.~      Objectives:~      - To investigate the safety and effectiveness of AT13387 in individuals with solid tumors.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors that have not responded to~     standard treatments.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood tests and tumor imaging studies.~        -  AT13387 will be given in 28-day cycles of treatment. Participants will receive AT13387~          twice a week (2 days in a row) for the first 3 weeks of the cycle, followed by a fourth~          week without the drug.~        -  Participants will have regular blood and urine samples, imaging studies, eye~          examinations, and tumor biopsies to monitor the effects of the treatment.~        -  Participants will continue treatment with AT13387 unless serious side effects develop~          or the tumor stops responding to treatment....~   "
138215|NCT01246089|"~     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal~     injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).~   "
138216|NCT01246076|"~     The purpose of this study is to determine the proportion of confirmed responses (complete~     response, partial response, and hematologic improvement as defined by revised IWG criteria~     during the 12 months of treatment.~   "
138217|NCT01246063|"~     The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of~     carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or~     without dexamethasone, and then to establish the efficacy and safety of this novel~     combination in patients with relapsed or refractory multiple myeloma~   "
138218|NCT01246050|"~     The aim of this study is to serve as a pilot showing the feasibility of a Hub and~     Satellite Heart Failure (HF) Provider's Network which will aim to provide improved,~     evidence-based care to veterans with HF. Primary Care Providers in the VA Community Based~     Outpatient Clinics will undergo a brief period of intensive training in HF management and~     then practice in a network of primary care providers supported by the Regional HF Center.~   "
138219|NCT01246037|"~     The main question of this study is: 'Is selective beta-blocker treatment safe and effective~     in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients~     with iPAH?'.~      In addition to the determination of RVEF, the investigators will explore how beta-blocker~     therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise~     capacity and mechanical efficiency.~      30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a~     double-blinded fashion. A cross-over trial design will be used to increase the power of the~     study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The~     medication will be given in an escalating dose regimen (as described in the~     'farmacotherapeutisch kompas', www.fk.cvz.nl) and treatment will be monitored along the~     guidelines of the American Heart Association.~   "
138220|NCT01246024|"~     To investigate the influence of induced hypoxia on the ERG.~   "
138221|NCT01246011|"~     Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just~     undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive~     antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be~     randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result~     and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with~     a negative antibody result will also be followed in the study. All subjects will have a~     cardiac CT scan at about 30 days post surgery to measure the patency of their coronary~     artery bypass vein grafts. This study will evaluate if treating patients who have heparin~     PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term~     patency of coronary artery bypass vein grafts.~   "
138222|NCT01245998|"~     The aim of the study is to establish whether treatment of ST with low-molecular-weight~     heparin in preventive or therapeutic doses prevents disease progression and thromboembolic~     events (deep vein thrombosis and pulmonary embolism), whether efficacy of~     low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment),~     and to recognize groups of patients in which treatment with heparin is most efficient, as~     well as to determine factors that influence the efficacy of ST treatment with heparin.~   "
138223|NCT01245985|"~     TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by~     radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and~     toxicity of the combination regimen.~   "
138224|NCT01245972|"~     This is a research study to find out more about the use of the pulsed dye laser in the~     treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not~     invaded deep into the skin. The purpose of this study is to determine whether the use of the~     pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage~     squamous cell carcinoma.~      Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that~     have a prominent blood vessel component. It has been used to treat broken blood vessels on~     the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions~     with a prominent vascular component.~   "
138226|NCT01245946|"~     -  Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens~          and some people may continue throughout adulthood.~        -  Topical retinoids related to oral antibiotics are considered first-line treatment of~          moderate inflammatory acne.~        -  Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid~          (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of~          inflammatory acne. Although progress has been made in the study of photodynamic therapy~          for acne, to date, no study has compared PDT with standard and well-validated~          pharmaceutical treatments and with the current recommended therapy for most types of~          acne combination therapy with a topical retinoid plus one or more antimicrobial agents.~      Hypothesis~        -  PDT with the photosensitizer ALA will be effective and safe for the treatment of~          moderate facial inflammatory acne.~        -  The ALA-PDT is more effective than conventional therapy with oral antibiotics and~          topical retinoids in the treatment of moderate inflammatory acne with faster action at~          12 weeks of follow-up.~   "
138227|NCT01245933|"~     The purpose of this study is to determine the prevalence and severity of extrapulmonary~     disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and~     mortality of COPD patients.~      Furthermore the investigators evaluate the relationship between systemic inflammation and~     organ involvement.~   "
138228|NCT01245920|"~     This randomized clinical trial will involve at least 25 patients who have selected to~     receive a dental implant to replace a missing tooth. One group will receive the test~     treatment of a bone graft and a dissolvable membrane at the outer surface of the dental,~     while the control group will not receive the bone graft and membrane adjacent to the~     implant.~      The following will be measured: bone thickness and height adjacent to implant, inflammation~     of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success.~     Patients will be followed for 1 year, including evaluation time points at 2 weeks, 1 month,~     3 and 6 months, and 1 year. Statistical analysis of the data will be conducted.~      The hypothesis is that there is no difference with regard to bone thickness, bone height,~     pocket depth, bleeding, and implant success rate for grafted implant sites compared to~     non-grafted implant sites.~   "
138229|NCT01245907|"~     The aim is to evaluate effects of internet-based applied relaxation (a simplified version of~     cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom~     (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited~     and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is~     a non-treated waitlist group.~      At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women~     will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of~     Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital~     Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as~     well as one about knowledge of the climacteric and hormone therapy).~      The waiting list group will be offered internet based AR after 10 weeks with the same~     follow-up as the treatment group.~   "
138230|NCT01245894|"~     The aim of this study was to measure the effect of low- and high-dose lipid-lowering~     treatment with rosuvastatin on the coronary physiology parameters.~   "
138231|NCT01245881|"~     In several observational studies, non-ablative fractional photothermolysis (FP) has been~     reported to bridge the gap between efficacy and tolerability in the treatment of melasma.~     While some beneficial effects have been attributed to non-ablative FP in treating melasma,~     methodological constraints (e.g., a limited number of patients; no control group assignment)~     impair efficacy assessment; currently published results neither allow researchers and~     clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular,~     bias resulting from poorly designed trials may mislead clinicians into making a wrong~     decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side~     effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and~     safety of FP in the treatment of melasma as compared to the lone application of a~     sun-blocking lotion (SPF >50).~   "
138232|NCT01245868|"~     The purpose of the study is to investigate if a small amount of lignocaine added to~     bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can~     shorten the duration of the sensoric and the motoric blockade.~   "
138233|NCT01245855|"~     we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce~     myocardial injury and improve clinical outcomes in patients undergoing PCI.~   "
138234|NCT01245842|"~     The purpose of this study is to evaluate the effect of a hand exercise intervention on~     function and osteoarthritis symptoms in persons with hand osteoarthritis .~   "
138235|NCT01245829|"~     Sepsis contributes to nearly 20% of all hospital deaths and is the leading cause of death on~     non-coronary intensive care units. Contamination of the patient environment is common with~     organisms such as MRSA, VRE and C.difficile remaining viable for days or weeks on a variety~     materials and surfaces. Up to 90% of patient notes and charts on critical care may be~     contaminated with potential pathogens including MRSA and it has been shown that healthcare~     workers may contaminate hospital paperwork with organisms originating from patients.~     Cellomed is a triclosan based laminate which has been shown to possess antimicrobial~     activity against MRSA, E.Coli, Enterococcus, Stenotrophomonas and Klebsiella. The study~     presented for consideration aims to compare levels of contamination between critical care~     observation charts coated with either a 'standard' matt or antimicrobial Cellomed laminate.~     It is proposed that paperwork laminated with Cellomed may exhibit reduced levels of~     contamination and decrease the potential for cross infection on critical care and~     potentially other areas of the hospital in which clinical paperwork is handled.~   "
138236|NCT01245816|"~     The purpose of this phase III study is to evaluate the safety and efficacy of the~     combination of eflornithine and sulindac compared to single agent sulindac or eflornithine~     in reducing the number of polyps in patients with familial adenomatous polyposis (FAP).~   "
138237|NCT01245803|"~     Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI~   "
138273|NCT01245075|"~     The main objective of this study is to assess the efficacy of bilateral deep brain~     stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid~     addiction. The included patients have been treated so far with a substitute in form of~     methadone.~      Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for~     heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.~   "
138238|NCT01245790|"~     A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects~     with impaired kidney (renal) function compared with healthy volunteers with normal renal~     function. Stage 1 will include healthy subjects and subjects with end stage renal disease,~     while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment~     dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in~     subjects with renal impairment.~   "
138239|NCT01245777|"~     In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population.~     During pregnancy iron tablets are the only available safe medication but their efficacy is~     rather poor. It is the aim of this study to examine the efficacy, practicability and safety~     of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of~     Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.~      20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy~     will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood~     tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires~     concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of~     iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.~        -  Trial with medicinal product~   "
138240|NCT01245764|"~     The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose~     regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in~     Sub-Saharan Africa. Data from the current study are needed in order to complement existing~     extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™~     may be administered safely and will induce immune responses in populations from and living~     in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the~     world.~   "
138241|NCT01245517|"~     Aim:~      Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior~     of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of~     hemodialysis patients.~      Inclusion criteria:~      The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at~     baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0~     mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion.~      Subjects will be enrolled into this trial after signed informed consent. We expect to~     recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor,~     can't finish all education sessions and/or can't complete dietary records monthly. We will~     recruit a control group into this trial, they are eligible for inclusion but don't want to~     participant education sessions.~      Intervention protocol:~      At baseline, the investigators collect demography and pre-test KAP questionnaires among all~     subjects. If subjects were illiterate then investigator will conduct face-to-face interview~     and record their answers. Dietary Phosphorus Education is a 6-month program and be~     implemented by dietitians and investigators, including education, nutritional counseling and~     dietary records monthly.~      The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and~     third month were monthly education sessions, each 20 to 30 minutes. There are total 6~     sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry~     data monthly, biochemistry measurements and 3-day dietary records among all subjects. If~     subjects were illiterate then investigator will conduct face-to-face interview or~     phone-interview to complete each dietary record. Investigator collect post-test KAP~     questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects~     in the end of the trial,. If subjects are illiterate then investigators interview subjects~     and record.~      This is a 6-months trial and retrospective study to collect anthropometry, biochemical~     measurements and 3-day dietary records from control subjects monthly.~   "
138242|NCT01245504|"~     Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities~     may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and~     may require more work by prosthetists to redesign the socket. The aim of this research is to~     assess the accuracy of prosthetic sockets manufactured by commercial companies.~     Determination of how and where manufacturing errors occur will contribute to better quality~     of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the~     manufactured products to their patients.~      Computer manufactured sockets are made for subjects, then their fits assessed by research~     practitioners.~   "
138243|NCT01245491|"~     The purpose of this study is:~        1. To study the effect of whole-body vibration on partial pressure of oxygen in arterial~          blood (PaO2), under hypobaric hypoxic conditions.~        2. To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast~          sensitivity.~        3. To se if there is an increase in cytokines and other biomarkers under different~          hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause~          PaO2 to drop to a lower level, at a given altitude; than would be the case if there~          were no vibration present.~   "
138244|NCT01245478|"~     This will be a retrospective chart review of 200 charts of adult patients who have undergone~     a revision TKA at New England Baptist Hospital and who received implant component(s)~     manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients~     are seen clinically for a minimum of five years after surgery to answer:~        1. What is the five-year survivorship of revision a knee prosthesis containing components~          manufactured by DePuy Orthopedics among adult revision TKA patients?~        2. What patient factors are associated with the need for re-operation after revision TKA~          among patients receiving DePuy implant components? How do clinical outcomes change from~          baseline over the five-year follow-up after revision TKA surgery?~      Data collection will include patient-reported and clinician-reported measures.~   "
138245|NCT01245465|"~     In this study the investigators aim was to investigate the safety and possible efficacy of~     Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing~     the usefulness of a new online daily symptom registration system.~   "
138246|NCT01245452|"~     To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in~     early RA patients treated with tocilizumab compared to Methotrexate alone.~      The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population~     and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety~     profile of Tocilizumab.~   "
138247|NCT01245439|"~     This open-label study will evaluate the safety, tolerability and efficacy of~     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid~     arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current~     non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous~     infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment~     is 24 weeks.~   "
138248|NCT01245426|"~     This is a randomised, double-blind, placebo-controlled, parallel group study to determine~     the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced~     expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg~     GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion~     using the original doses, be terminated early, or have a fourth arm added of either 1mg~     GW870086X once daily or 3mg GW870086X once daily.~   "
138249|NCT01245413|"~     Aim~      The aim of the Athena project is to develop an ostomy product that is softer and more~     flexible in order to improve the comfort for people with a stoma.~      The present investigation aims at testing how well the new Athena base plate adhere to~     perspiring skin both with and without mechanical exposure (cycling) since the ability to~     adhere under normal daily activity is an important quality for Coloplast products.~      Success criteria:~      The investigation is an explorative investigation where the adherence of Athena on~     perspiring skin is evaluated. Due to the explorative nature of the study it has not been~     possible to define specific success criteria up front. However, the adherence qualities of~     Athena may not be significantly reduced compared to SenSura.~      Design:~      Two groups of men, one group with a colostomy and one group without a colostomy, are~     included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate~     intensity and with Athena and SenSura base plates applied on the back and stomach. The~     adhesion of the base plates are tested before and after the physical activities.~      Population:~      The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who~     have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be~     cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate~     intensity on an exercise bike.~      The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat~     custom cut base plate, a closed bag size midi or maxi with the intended use of collecting~     faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy~     product with a closed bag. SenSura is CE-marked and launched on the market.~   "
138250|NCT01245400|"~     The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational~     Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared~     to Allograft.~   "
138251|NCT01245387|"~     Long-term observational study to assess the safety, efficacy and quality of life of patients~     with neovascular age-related macular degeneration (AMD) under Macugen treatment.~   "
138252|NCT01245374|"~     This study is conducted in Europe. The aim of this study is to compare the easiness of use~     of Norditropin NordiFlex® device to the device previously used by patients or parents.~   "
138253|NCT01245361|"~     Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP)~     antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a~     higher rate of erosion and a higher risk of progressive and severe RA.~      The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is~     superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more~     effective.~      The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial~     studies from patients with early arthritis suggest that UA and RA may share common~     immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early~     arthritis demonstrates synovitis in more than half of the joints samples with prominent T~     cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).~      Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on~     multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence~     the clinical outcome.~      Recently, Methotrexate has been demonstrated to improve the course of undifferentiated~     arthritis and prevent the development of RA. Short regimen of more intensive therapy with~     Infliximab could alter the radiological, immunopathological and clinical outcome.~   "
138254|NCT01245348|"~     The purpose of this study is to validate that SULT4A1-1 status stratification improves~     responses to atypical antipsychotics in schizophrenia and to extend these findings into~     bipolar disorder.~   "
138255|NCT01245335|"~     Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed~     for proper function. This severe lack of blood flow can lead to painful legs while walking~     or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose~     of this study is to determine if injections of concentrated bone marrow into damaged tissues~     will result in improved blood flow. If successful, this treatment could improve blood flow~     to the lower limb, reduce pain, and reduce the frequency of limb amputations.~   "
138256|NCT01245322|"~     The primary objectives of this study were to characterize lactobacilli of human vaginal~     origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis,~     together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore,~     to investigate factors that could influence relapse.~   "
138257|NCT01245309|"~     Scratching the linning of the womb before IVF cycle could increase the chances of having a~     baby after an IVF cycle.~   "
138258|NCT01245296|"~     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by~     increasing the infant's iron endowment at birth. Compared with early clamping, a delay of~     around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.~      The results of previous intervention studies on delayed clamping are mixed, and few followed~     up infants beyond the perinatal period. All longer follow up studies have been performed in~     low income countries. The main objectives, therefore, was to assess whether delayed cord~     clamping improves hematological and iron status at 4 respective 12 months of age in a large~     sample of full-term, Swedish infants.~      The investigators also choose to investigate if the timing of clamping the umbilical cord~     could affect rate of infections during the first four months of life and to assess the~     infants development at 4 and 12 months of age.~   "
138259|NCT01245283|"~     The purpose of this study is to determine if a 4 month resistance exercise program can~     reduce knee osteoarthritis pain functional impairment and cartilage turnover.~   "
138274|NCT01245062|"~     This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212~     to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV~     malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample.~     Subjects who have received up to one prior regimen of chemotherapy in the advanced or~     metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or~     MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1~     randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy~     arm). The primary endpoint for the statistical analysis will be a comparison of progression~     free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have~     progression on chemotherapy will be offered the option to receive GSK1120212.~   "
138260|NCT01245270|"~     Dietary strategies for alleviating health complications associated with type 2 diabetes~     (T2D) are being pursued as alternatives to pharmaceutical interventions. Berries such as~     bilberries that are rich in polyphenols may influence carbohydrate digestion and absorption~     and thus postprandial glycaemia. In addition berries have been reported to alter incretins~     as well as to have anti-oxidant and anti-inflammatory properties that may also affect~     postprandial glycaemia. This study investigated the acute affect of a standardised bilberry~     extract on glucose metabolism in T2D.~      Eight male volunteers with T2D controlling their diabetes by diet and lifestyle alone were~     given a single oral capsule of either 0.47g standardized bilberry extract (36% (w/w)~     anthocyanins) which equates to ∼50 g of fresh bilberries or placebo followed by a~     polysaccharide drink (equivalent to 75 g glucose) in a double blinded cross over~     intervention with a two week washout period.~      This study demonstrates that the ingestion of a concentrated bilberry extract reduces~     postprandial glycaemia and insulin in volunteers with T2D. The most likely mechanism for the~     lower glycaemic response involves reduced rates of carbohydrate digestion and/or absorption.~   "
138261|NCT01245257|"~     Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with~     alcoholic hepatitis. The liver might play an important role in this stress-catabolism by~     increasing the production of urea during the inflammatory process.~      The purpose of this study is to examine the regulation of urea synthesis in patients with~     alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and~     pentoxifylline on this regulation.~   "
138262|NCT01245244|"~     The aim of the current project is to use a model of painful stimulation of skin, muscles and~     internal organs, where it is possible to measure activity in the brain centers that process~     pain simultaneously. Magnetic resonance imaging and electroencephalography are combined to~     optimize the anatomical and physiological description of brain activation. During~     administration of morphine we will identify how different brain areas are affected. This~     knowledge will be used to:~      1. Understand the mechanisms of morphine to a greater extent than is possible today,~     including:~        1. to investigate the mechanisms of morphine versus placebo on pain signals in the spinal~          cord and brain. This is done by a combination of experimental pain models,~          neurophysiological and imaging techniques (EEG and fMRI). This can be achieved as both~          subjective and objective measures of the analgesic effect.~        2. to examine morphines effect on communication between the centers of the brain that are~          involved in painprocessing .~        3. modeling of morphine pharmacokinetics (the understanding of what the body does to the~          drug, such as. concentration in the blood and the brain), since this is central to~          understand the pharmacodynamics (the description of what the drug does to the body and~          thus the effect it has).~        4. to identify biomarkers that can predict whether healthy subjects respond to morphine by~          experiencing an analgesic effect.~   "
138263|NCT01245231|"~     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors predict how patients will respond to~     treatment.~      PURPOSE: This research study is studying prognostic biomarkers in cell samples from young~     patients with acute myeloid leukemia.~   "
138264|NCT01245205|"~     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and~     lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread~     to other places in the body. Akt inhibitor MK2206 and lapatinib ditosylate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
138265|NCT01245179|"~     The goal of this clinical research study is to find out about the safety and effects of a~     drug called panobinostat when given to adults with sickle cell disease. Panobinostat is a~     pan histone deacetylase (HDAC) inhibitor. HDAC inhibitors have been shown to significantly~     increase hemoglobin F induction, which is well documented to improve outcomes in sickle cell~     disease. HDAC inhibitors are also known to potently inhibit cell-specific inflammation,~     which is a primary contributor to the debilitating effects of sickle cell disease. Given the~     relevance of these mechanisms of action in SCD, panobinostat may prove to contribute~     significantly to the management of SCD patients, a population in critical need of further~     effective treatment options.~   "
138266|NCT01245166|"~     Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin~     secretion deficiency and insulin action defect. In this type of subjects, fasting~     hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it~     is coexisting with hyperinsulinemia.After a meal, the impaired control of hepatic glucose~     production by insulin and decreased insulin-mediated glucose uptake by muscle contributed~     nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects~     experience significant morbidity and mortality from microvascular (retinopathy, nephropathy,~     and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular~     disease) complications. The appropriate treatment and good glycemic control of diabetes is~     therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy~     using oral antidiabetic agents with different mechanisms of action may be more effective in~     achieving and maintaining target blood glucose level (Turner et al., 2005).There are five~     classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase~     inhibitors, thiazolidinediones and meglitinides) currently available to improve glycemic~     control in subjects with type 2 diabetes, each of which works through a different mechanism~     of action. Metformin, a biguanide which has insulin-sensitizing properties, can be used~     alone or in combination with other classes of agents. Metformin is the currently the~     first-choice treatment in subjects with diagnosed type 2 diabetic subjects and obesity,~     characterized by insulin-resistance. Metformin also provides reduction of body weight and~     ameliorates lipid abnormalities and is thought to be related to a reduction in hepatic~     gluconeogenesis (Hundal & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved~     for the treatment of type 2 diabetes, and first approved for prediabetes treatment (Chiasson~     et al., 1994; Breuer, 2003; Chiasson et al., 2002). The drug was launched worldwide as a~     type 2 diabetes monotherapy and combination therapy in 1990 which has proven efficacious as~     first-line therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin~     (Kelley et al., 1998). Acarbose and metformin are both associated with beneficial effects on~     hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels~     (Krentz et al., 1994). Because these factors are part of a cluster of risk factors for~     cardiovascular disease, combining the two drugs may be useful. In long-term clinical~     studies, acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination~     with metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et~     al., 1998; Halimi et al., 2000). This study was conducted as a further vestigation into the~     efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus~     subjects.Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate~     assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes~     mellitus subjects considered inadequately blood glucose control. Since combination tablet of~     acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted~     to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the~     treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an~     active-comparator.~   "
138267|NCT01245153|"~     Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle~     training(PFMT) is the standard recommendation for conservative treatment but some patients~     had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not~     perform the PFMT properly or increase intensity of the exercise. The authors hypothesized~     that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as~     it is another option of progressive strengthening of pelvic floor muscle. This study's aim~     is to combine RBT with PFMT using the water-filled balloons of Foley catheters~   "
138268|NCT01245140|"~     The main purpose of this study is to demonstrate the improvement in the skin condition rate~     of patients receiving alitretinoin compared to patients receiving placebo.~   "
138269|NCT01245127|"~     Schnitzler syndrome:~      Schnitzler syndrome is a rare disabling autoinflammatory syndrome characterized by a chronic~     urticarial rash and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or~     arthritis or bone pain. Diagnostic criteria have been established. The disease never remits~     spontaneously. Although there is no standard of care, there have been promising developments~     in therapeutic options, especially anti-interleukin-1 therapy. Anakinra, a synthetic~     analogue of the endogenous interleukin-1 receptor antagonist, has caused rapid clinical~     remission in 24 patients with Schnitzler syndrome. However, to sustain remission, continuous~     daily administration (100 mg sc) is required. The level of monoclonal protein does not~     decrease. Side effects of anakinra include painful injection site reactions and neutropenia.~      Interleukin-1 and the autoinflammatory diseases:~      As a key proinflammatory cytokine mediating local and systemic responses to infection and~     tissue injury, interleukin-1 can induce a range of responses, including fever, pain~     sensitization, bone and cartilage destruction, and the acute-phase inflammatory response.~     The so-called autoinflammatory diseases are mediated entirely by interleukin-1; reducing~     interleukin-1 activity brings about a rapid and sustained remission. Autoinflammatory~     diseases include relatively uncommon disorders such as familial Mediterranean fever, adult~     and juvenile Still's disease, the hyper-IG D syndrome, Behçet's syndrome, the~     cryoporin-associated periodic syndrome (CAPS), deficiency of the interleukin-1 receptor~     antagonist (DIRA) and Schnitzler's syndrome. Some common conditions such as gout and type 2~     diabetes, are also likely to be autoinflammatory diseases.~      Canakinumab:~      Canakinumab (Ilaris, Novartis Pharma) is a fully human anti-interleukin-1-bèta monoclonal~     antibody. Treatment with subcutaneous canakinumab (150 mg) once every 8 weeks was associated~     with a rapid remission of symptoms in the great majority of children and adults with CAPS.~     Serum inflammatory markers quickly returned to normal. In general, the side effects seen in~     this small study (35 patients) were not serious, though suspected infections ware~     significantly more prevalent in patients receiving canakinumab than in those receiving~     placebo. The prolonged duration of action of canakinumab and low incidence of injection-site~     reactions may confer certain advantages over other interleukin-1 inhibitors (anakinra and~     rilonacept), since both are frequently associated with injection-site reactions, and both~     require more frequent administration (daily for anakinra and weekly for rilonacept).~      Canakinumab was approved for the treatment of CAPS by the US Food and Drug Administration in~     June 2009 and by the European Medicines Agency in October 2009.~      Canakinumab is currently being evaluated for its potential in the treatment of~     systemic-onset juvenile idiopathic arthritis, diabetes mellitus, and difficult-to-treat~     gouty arthritis.~   "
138270|NCT01245114|"~     Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on~     retinal structure and function as well as anterior chamber in regard to acute mountain~     sickness.~   "
138271|NCT01245101|"~     This study will examine whether intensification with raltegravir of a suppressive~     antiretroviral regimen in HIV infected patients with poor immune restoration has a~     beneficial effect on cryptic viral replication and the immune system. Specifically, the~     investigators will examine the effect that raltegravir intensification of ART has on~     episomal cDNA frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of~     microbial translocation.~   "
138272|NCT01245088|"~     Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to~     moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed~     through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical~     effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.~   "
138275|NCT01245049|"~     The purpose of the study is to compare the immunogenicity and safety of a booster dose of~     BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a~     second dose of PriorixTM, in healthy 3 and 4-year-old children.~   "
138276|NCT01245036|"~     From the time sarcoidosis has been described, there has always been a belief that the~     disease is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in~     sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT)~     is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but~     the results of these trials have been discouraging. These trials were generally small~     studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic~     acid and streptomycin. In our experience nearly one third of patients who are finally~     diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact~     of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized~     controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid~     along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.~   "
138277|NCT01245023|"~     Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has~     been only one previous controlled study, that stated laparoscopy alone had the same benefits~     than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic~     adhesiolysis with a placebo-procedure in chronic abdominal pain.~   "
138278|NCT01245010|"~     Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption~     promote a decrease in triglycerides blood levels over 9 months in overweight women? The~     primary outcome variable is the triglycerides blood level. In addition, the investigators~     will consider as secondary outcome variables the following parameters of metabolic syndrome:~     weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood~     pressure, and waist circumference. The investigators will also consider as an outcome~     variable glycosylated (or glycated) hemoglobin (HbA1c).~      Design: Two groups randomized controlled trial, with an intervention group (water and~     education provision) and control group (education provision only).~      The investigators propose to recruit young adult women aged >18-<45 y who are overweight or~     obese (BMI >25 and <39), and consume at least 250 calories per day from caloric beverages~     (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic~     beverages) The intervention group (water and education provision) will be compared with a~     control condition (education provision only). The intervention has been proposed to be~     carried out for 9 months period with objective measurements of body weight and fat, total~     cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure,~     and 24 hrs dietary recalls at baseline, 3,6 and 9 months~   "
138279|NCT01244997|"~     IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue~     response comparing immediate with delayed implant after tooth removal, with immediate~     provisionalization, in maxillary anterior sites.~      The purpose of this study is to determine and compare the crestal bone levels as the primary~     endpoint variable for implants placed and temporized in extraction sites, to implants placed~     into extraction sites after the extraction site has been grafted and healed for 4 months,~     all immediately restored with an anatomic provisional restoration.~   "
138280|NCT01244984|"~     The primary purpose of the study is to assess the safety and tolerability of 52-week~     teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation~     powder once-daily in Japanese adult subjects with asthma.~   "
138281|NCT01244971|"~     The purpose of this study is to investigate the impact of exercise training, Acarbose, and~     the combination of exercise and Acarbose on glycemic control, body composition, insulin~     sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle~     biopsies will be obtain to study gene expression. Our hypothesis is that the combination~     therapy will be superior to monotherapy with exercise or Acarbose.~   "
138282|NCT01244958|"~     Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven~     synergistic effects in patients with either lymphoma or autoimmune diseases. First data of~     uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.~   "
138283|NCT01244945|"~     The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during~     the last century in western countries. In the USA and Northern Europe, constipation is~     twofold the prevalence found in the East and Southern Europe. In Italy, constipation affects~     up to 15-17% of the whole adult population. Of them, more than half (about 10%) treats this~     disorder by assuming laxatives, while the remaining does not even assume drugs. A close~     relationship between intestinal environment and bacterial flora has been found. As a matter~     of fact changes in the intestinal physiology can modify the composition of bacterial flora~     as well as modifications in the intestinal microbiota can modify the physiology of the gut.~     The probiotic effects on the GI motility can be due to substances released by bacteria~     and/or products of their fermentation. Also, probiotic may indirectly act by the release of~     neuroendocrine factors and/or substances released by the immune system. Clinically, it has~     already been demonstrated that probiotics exert a positive effect on symptoms and intestinal~     habit in constipated IBS patients. In this framework, the idea to perform a long lasting~     intervention study in patients with functional constipation treated with probiotics sounds~     convincing. The present study is a randomized, double blind, placebo controlled, monocentric~     study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus~     reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria.~     Clinical, physiological, hematological and immunologic variables will be evaluated.~   "
138284|NCT01244932|"~     The purpose of this study is to determine the minimum effective volume of local anesthetic~     for interscalene brachial plexus block using ultrasound guidance and nerve stimulator~     guidance.~   "
138285|NCT01244906|"~     This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus~     following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced~     intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease~     the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune~     reconstitution, thereby improving the safety of the procedure. The past experience with~     post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism,~     which the investigators hope will translate into improved disease control through the well~     documented graft-versus-malignancy effects of donor T cells.~   "
138286|NCT01244893|"~     The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to~     process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the~     process qualification (postPQ).~   "
138287|NCT01244880|"~     To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during~     causal learning as measured by fMRI compared to placebo in healthy human subjects, and to~     evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced~     by treatment with PF 02545920.~   "
138288|NCT01244867|"~     The primary objective is to assess the immunogenicity and safety and tolerability of two~     consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in~     part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®,~     compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).~   "
138289|NCT01244854|"~     Persons with serious mental illness are at increased risk of cardiovascular disease. The~     goals of this study are to test a treatment, Life Goals Collaborative Care to help promote~     health behavior change and to get feedback from patients and providers on what is needed to~     help better coordinate and physical and mental health care of these patients.~   "
138290|NCT01244841|"~     In patients with ST elevation myocardial infarction (STEMI)treated with primary percutaneous~     coronary intervention (PPCI) a subset with low risk for late complications can be~     identified. Early discharge (<72h) of these patients can compromise initiation of~     prophylaxis, information and other investigations. The researchers want to investigate~     prospectively whether early discharge compared to regular care have comparable patient~     centered outcomes at 30 days follow-up.~   "
138291|NCT01244828|"~     This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in~     participants with schizophrenia. Participants in this study consist of schizophrenia with~     residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory,~     or elderly participants with schizophrenia. The treatment period is up to 52 weeks.~   "
138292|NCT01244815|"~     Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed~     episodes) will be evaluated in participants between 10 and 17 years old, who are either~     hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial,~     eligible participants will be randomized to receive one out of three fixed dose levels of~     asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is~     superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating~     Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking~     sublingual tablets; concurrent use of psychotropics is prohibited, except use of~     short-acting benzodiazepines and psychostimulants approved for the treatment of attention~     deficit hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and~     safety is evaluated using the recordings of adverse events, routine blood panels, physical~     examinations (including vital signs), and electrocardiograms. Participants who complete the~     double blind trial may be offered to continue (open-label) treatment with asenapine for an~     extended period of time. Follow-up information on safety parameters will be collected in all~     participants within 30 days following treatment discontinuation.~   "
138293|NCT01244802|"~     The objective of this study is to study immune memory generated against the yellow fever~     (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not~     receive vaccine shots; only immune responses to previous yellow fever vaccination will be~     studied. The study involves one or multiple blood draws.~   "
138294|NCT01244789|"~     Patients with stage 1 & 2 endometrial cancer are treated with surgery. Despite the fact that~     disease is confound to uterus, unfortunately some of these patients may relapse and die of~     their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown~     survival benefit in more advanced stage disease (stage 3 & 4).~      This study evaluates if one can improve survival in intermediate and high risk early-stage~     patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial~     where effect of postoperative chemotherapy is compared with postoperative observation alone~     (standard strategy).~      Substudy: Translational research~   "
138295|NCT01244776|"~     This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular~     corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.~   "
138296|NCT01244763|"~     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the~     correction of anemia in non-dialysis chronic kidney disease patients.~   "
138297|NCT01244750|"~     The purpose of this study is to better understand the use of tyrosine kinase inhibitors~     (TKI) in patients newly diagnosed with CML and their quality of life in a real-world~     setting.~   "
138298|NCT01244737|"~     Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is~     important in the management of these tumors, but current imaging methods have limitations in~     providing the necessary information for optimal treatment of these patients. The goal of~     this study is to evaluate the potential utility of positron emission tomography (PET) with~     3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in~     children. Funding source - FDA Office of Orphan Product Development (OOPD)~   "
138299|NCT01244724|"~     The primary objective will be to pilot the use of escitalopram for the treatment of major~     depression in patients with epilepsy. The secondary objectives will be to determine effect~     sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and~     quality of life, and to evaluate safety in the population of patients with epilepsy.~      These results will be used to evaluate the possibility of a future double-blind, placebo~     controlled RCT of escitalopram for the treatment of major depression in patients with~     epilepsy.~   "
138300|NCT01244711|"~     The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and~     indices of psychosocial function will all improve, while BZ use will decrease significantly~     during a twelve-week trial period of substituting quetiapine for benzodiazepines.~   "
138311|NCT01244568|"~     Researchers in this study will determine whether providing decision support interventions~     (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and~     alters their treatment decisions.~   "
138312|NCT01244555|"~     The purpose of this study is to determine the effectiveness of treatments (massage therapy~     or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension~     headache.~   "
138327|NCT01244360|"~     The purpose of this study is to examine the effects of resveratrol on health and human~     performance. The study will evaluate cognitive function and several indicators of physical~     health before and after taking a resveratrol supplement or a placebo for three weeks.~   "
138301|NCT01244698|"~     Antibiotics are used routinely in postoperative tissue expander based breast reconstruction~     (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are~     also used routinely in immediate breast reconstruction to prevent fluid accumulation and~     seroma formation at the surgical sites. Antibiotics are most often prescribed as a~     precaution since drains can be a source for infection by creating open channels to outside~     contaminants. Plastic surgery patients without closed suction drainage devices are usually~     not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic~     prophylaxis is recommended for up to 24 hours only. These recommendations do not take into~     account the increased risk of indwelling closed suction drains. A recent survey of plastic~     surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are~     divided as to extended outpatient administration following TE breast reconstruction.~      The study plans to prospectively enroll patients who will undergo immediate breast~     reconstruction with TE or AF based breast reconstruction. Using the above data and the~     current protocol, the investigators will investigate the optimal antibiotic discontinuation~     period for these patients. The investigators hypothesize that the use of 24-hour~     perioperative antibiotics in TE or AF based immediate breast reconstruction with closed~     suction drainage, does not result in an increased infection rate compared to prolonged~     postoperative antibiotic administration.~   "
138302|NCT01244685|"~     The purpose of this study is:~        -  To determine if the intraoperative fluid administration with the Deltex CardioQ~          esophageal Doppler will reduce the length of stay after elective bowel resection.~        -  The probe can be used to dynamically measure stroke volume and cardiac output. This~          information will assist us in determining the ideal amount of fluids to be~          administered.~        -  To determine if the fluid administration established by the esophageal probe will~          result in a shorter length of stay in elective bowel resection patients.~        -  The investigators plan to enroll 100 patients in this study.~   "
138303|NCT01244672|"~     The purpose of this study is to compare the frequency and severity of postoperative( after~     surgery) pain between two surgical techniques for treating severe hemorrhoids. The two~     techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical~     excision (removal) of the hemorrhoids~   "
138304|NCT01244659|"~     Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS~     and Prograf® in post renal transplanted patients.~   "
138305|NCT01244646|"~     1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will~          be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus~          will receive additional treatment with a sulfonylurea (SU) derivative. At the start and~          at 3 and 6 months, during regular visits to the patient's General Practitioner, the~          patients will complete a series of questionnaires (Patient Reported Outcomes, PROs)~          directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment~          compliance and at general wellbeing. These PROs are the worry subscale of the~          Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes~          Symptom Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence~          Report Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence~          of hypoglycemic events and body weight changes will be assessed and the level of~          adherence to treatment will be investigated.~        2. Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last~          month), informed consent provided, in whom a SU therapy is added. Patients with Type 1~          diabetes and with secondary diabetes will be excluded, and patients unable to~          understand and complete the questionnaires.~        3. Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the~          frequency of hypoglycemic symptoms and body weight at 6 months and to weight change~          from 0 to 6 months. Secondary outcome variables are the other PROs. The frequency of~          hypoglycemic symptoms, incidence of hypoglycemic events, changes in body weight and~          level of compliance will be addressed.~        4. The Intention To Treat analysis will be used, with Last Value Extended Forward from 3~          to 6 months in case of withdrawal after 3 months. Changes in outcome variables will be~          analysed by modelling time and potential dummy variables in a Generalized Estimating~          Equations analysis.~        5. Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic~          symptoms, incidence of hypoglycemic events, body weight and change in body weight from~          0 to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships~          between (changes in) the different questionnaires, such as with hypoglycemia symptoms,~          weight (changes) and treatment compliance will be evaluated. A search is done for~          baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic~          symptoms, hypoglycemic events and weight changes.~   "
138306|NCT01244633|"~     Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The~     currently available drug treatments are considered to be inadequate. This clinical trial is~     designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in~     adults.~   "
138307|NCT01244620|"~     Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically~     relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5~     inhibitor).~      Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and~     ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP~     enzymes and transporter data, a clinically relevant drug-drug interaction between~     sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan~     pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil~     did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.~   "
138308|NCT01244607|"~     The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity~     of nickel-induced allergic contact dermatitis.~   "
138309|NCT01244594|"~     Background:~      People with spinal cord injury (SCI) are at risk for many health conditions, some of which~     can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one~     way to obtain exercise after SCI. However, cycling with FES has only been done one way,~     which involves pedaling more quickly with less force to work against. Pedaling more slowly~     would allow the person to work against more force, which may lead to greater improvements in~     bone mineral density and muscle size. It may also lead to greater changes in bone make-up,~     body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone~     fractures and cardiovascular disease, two major medical issues that exist in the SCI~     population. Study Aims: This study will compare the outcomes on bone, muscle and~     cardiovascular health between the commonly used method of pedaling more quickly to a new~     method of pedaling more slowly. Both groups will work against the maximal force possible. It~     is expected that the group pedaling more slowly will work against greater force and thus~     will have improved outcomes compared to other group pedaling faster. Methods: Twenty people~     with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will~     participate in three 60-minute sessions per week for 6 months at an outpatient~     rehabilitation center. All subjects must have complete paralysis of both legs, but may have~     sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan~     to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical~     stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to~     measure cholesterol, bone factors that provide insight into bone change, and nutritional~     status. Relevance: If the protocol of pedaling more slowly results in greater improvements,~     this technique can be applied to clinical practice. Some people with SCI have FES cycles in~     their homes and many have been cycling for many years. This new technique may allow them to~     obtain more benefits than what they currently are receiving from FES cycling. In addition,~     it is important to maintain overall bone, muscle and cardiovascular health so that people~     with SCI are health and ready when spinal cord regeneration becomes clinically available.~   "
138310|NCT01244581|"~     The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating~     acute otitis media in children. The primary end point is time to disappearance of middle ear~     effusion which monitored by daily tympanometry performed by families and study physicians.~   "
138313|NCT01244542|"~     The aim of the investigators project is to explore the mechanisms of pain insensitivity in~     patients with schizophrenia, in order to prevent its invalidating consequences. The~     investigators will couple methods of experimental psychology with EEG and blood samplings,~     in order to distinguish the role of non-painful perception, attention, aversive effects, and~     pain expression, and the investigators will explore an original neurobiological hypothesis~     regarding the activation of opioid receptors.~   "
138314|NCT01244529|"~     The purpose of this study is to evaluate the comparability of lens fit and lens power of a~     new contact lens to the lens fit and lens power of two marketed lenses.~   "
138315|NCT01244516|"~     The purpose of this study is to compare the clinical performance of three silicone hydrogel~     contact lenses over a 2 week period.~   "
138316|NCT01244503|"~     The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be~     used as an aid, in conjunction with other clinical information and medical history, for~     evaluating disease severity and detecting NASH with a high probability.~   "
138317|NCT01244490|"~     For children and adolescents, how does SPD503 compare to placebo for the treatment of~     Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
138318|NCT01244477|"~     Traumatic experiences can have a profound negative effect on the lives and well-being of~     both the people who experience them and their loved ones. For those who experience~     post-traumatic stress disorder (PTSD), their interpersonal difficulties and social support~     further impact the success of treatment such that interpersonal difficulties are associated~     with mistrust and predict poor treatment outcome. In this proposal, the investigators use~     functional neuroimaging to understand the neurobiology of trust and mistrust in people with~     PTSD and to learn more about how successful treatment can improve trust and social~     functioning.~   "
138319|NCT01244464|"~     This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in~     China.~      Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™~     administered at 2, 3, and 4 months of age in population aged over 2 months old living in the~     study city China.~   "
138320|NCT01244451|"~     In the last ten years there have been significant developments in CLL treatment. The advent~     of fludarabine, rituximab and the association of chemo-immunotherapy have substantially~     increased overall response rate, CR rate, time to progression and may also have an impact on~     overall survival.~      Even though, CLL remains incurable and all patients eventually relapse and progressively~     become resistant to treatment. The development of an effective therapy that is not~     cross-resistant with the ones currently available as front-line treatment, is one of the~     clinical unmet needs within CLL.~      BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of~     bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.~      Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating~     agents and purine analogue properties that may lack of cross resistance with fludarabine. It~     was utilized in CLL as a single agent and its association with rituximab is currently under~     clinical investigation.~      Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on~     CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is~     effective in highly pre-treated refractory CLL patients.~      Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis~     of these data, bendamustine and ofatumumab could be a new effective and well tolerated~     combination for patients with relapsed and refractory CLL.~   "
138321|NCT01244438|"~     An open-label, non-randomized, single arm study to assess the safety, tolerability, and~     pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced~     endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly~     starting at a dose of up to 16 mg/kg.~   "
138322|NCT01244425|"~     The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor~     Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local~     bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are~     insufficient.~   "
138323|NCT01244412|"~     This is the proof of concept study to evaluate the performance of an early stage prototype~     of a hand-held fundus camera.~   "
138324|NCT01244399|"~     Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise~     from failure of embryonic neural tube closure. Several studies have demonstrated that~     periconceptional administration of folic acid can prevent approximately 70% of all NTDs~     cases. The finding of several NTDs cases in a single family, despite prophylactic therapy~     with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no~     preventive therapy for folate-resistant NTDs is available. Studies performed on~     folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs~     occurrence. Preliminary results in patients with at least two previous pregnancies affected~     by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with~     500 mg/day of inositol (three months before conception and two months after) is able to~     prevent NTDs recurrence in humans.~      Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk~     of NTDs, especially for subgroups of people that carry genetic variants for enzymes involved~     in caffeine metabolism.~      The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest~     to pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether~     pre-conception caffeine intake interferes with prophylactic therapy for NTDs.~      In the proposed study, we aim to evaluate the effect of espresso consumption~     (corresponding to about 100 mg caffeine) on the pharmacokinetics of oral administered~     myo-inositol (MI), in order to highlight any possible negative effects of caffeine on MI~     adsorption and excretion before conception.~      The study will consist of two phases and will be carried on twelve healthy volunteers.~     During phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of~     this period, 20 g of MI will be administrated in a single dose. Basal levels of serum and~     urinary concentration will be evaluated before MI administration (t0); subsequently,~     sampling will be performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist~     of 15 additional days of inositol-poor diet: basal levels of MI will be again measured~     before MI administration. In phase 2, MI administration will be concomitant to caffeine~     exposure through singleespresso consumption. Samples will be collected at the same time~     points as in phase 1.~   "
138325|NCT01244386|"~     The purpose of this study is to validate the use of a low-dose computed tomography (CT)~     protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease~     (IBD). This is to be achieved using new computer software (Iterative Reconstruction and~     Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that~     of an abdominal radiograph.~   "
138326|NCT01244373|"~     To describe biocompatibility, postoperative results and complications after implantation of~     the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic~     acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.~   "
138547|NCT01241448|"~     LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is~     designed to compare LY2409021 given alone or given in combination with metformin against~     placebo the change in hemoglobin A1c after a 24-week treatment period.~   "
138328|NCT01244347|"~     In 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian~     randomised clinical trial have shown conclusively that the risk of neural tube defects can~     be reduced substantially by taking folic acid during the peri-conceptional period. At~     present there is enough evidence to support the hypothesis that folic acid supplementation~     can reduce the risk of all congenital malformations or of a specific and selected group of~     them, namely: neural tube defects, oral clefts, cardiac defects, urinary tract anomalies~     except hypospadias, limb reduction defects, omphalocele, anal atresia and trisomy 21.~      The hypothesis that a higher intake of folic acid is related to an higher risk reduction of~     neural tube defects and of other congenital malformations is the main rationale for the~     present study.~      The present study is a randomized, double-blind, controlled trial evaluating whether~     supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major~     congenital malformations in the population more than the standard recommended dose (0.4~     mg/day). At the enrolment visit all the eligible women will be interviewed to assess~     sociodemographic, life style and health status. After randomization, women will be~     interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy~     diagnosis during the study period will be interviewed by telephone at the expected 16, 24~     and 40 weeks of gestation to evaluate the pregnancy outcome. The health status of live~     births will be evaluated at the child's age of 1 month, 3 months and 1 year.~      The primary aim of this project is conducting a study to assess the effect of folic acid~     periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on~     reducing the occurrence of all congenital malformations. Secondary aims of this study~     include comparing severity of CMs in offspring of trial mothers, rates of selected~     congenital malformations, rates of twinning, miscarriages, recurrent abortions,~     small-for-gestational age, preeclampsia and abruptio placentae. The sample size is not easy~     to be computed because lacking robust estimate of the size effect of the treatment. Three~     hypotheses of a size effect of 45%, 26% and 13% were considered. A sample size of outcomes~     (and women) respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed.~     Since the sample size needed to evaluate different scenarios is large, the present study is~     also the pilot study to promote an international prospective meta-analysis.~   "
138329|NCT01244334|"~     The purpose of this clinical research study is to investigate the efficacy of predosing~     patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic~     emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal~     thickness.~   "
138330|NCT01244321|"~     The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm~     prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in~     the prevention of cardiac adhesion formation in patients submitted to VAD procedures.~   "
138331|NCT01244308|"~     It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for~     avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.~   "
138332|NCT01244295|"~     A comparison study of 16 week treatment with either specialized psychotherapy for~     complicated grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults~     with complicated grief.~   "
138333|NCT01244282|"~     This study will identify a dose of ferumoxytol that can reliably detect changes in blood~     flow/volume in response to non-drug stimuli. The study will determine whether signal~     detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than~     that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The~     following procedures will be conducted in each of two study periods: arterial spin labeling~     (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with~     sensory stimulation; MRI studies with sensory stimulation in the presence of increasing~     doses of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of~     ferumoxytol. There will be a 3-week interval between the two study periods. The study will~     enroll 8 subjects, but an additional 4 subjects are permitted to enroll to preserve study~     power.~   "
138334|NCT01244269|"~     This project aims to determine if methylphenidate can improve deficits in attention and~     symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with~     Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on~     postural control in these patients, a debilitating motor symptom that places patients at an~     increased risk of falling. This study will build on existing data to support a new~     indication for the use of methylphenidate in Parkinson's Disease. Using standard and~     objective evaluations, this study will quantify the effect of methylphenidate at two doses~     on attention levels, orthostatic hypotension, and measures of postural control. Phase I of~     the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the~     study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg~     three times daily to placebo. By incorporating two different doses, the study also seeks to~     determine if any improvements are dose-related. Secondary endpoints will include safety~     assessments (adverse event monitoring and vital signs) performed every 30 minutes following~     supervised drug administration. Visual analog scales will be presented to each participant~     before treatment and following the final dose of each treatment to assess changes in~     fatigue. A secondary task will be added to postural tests to assess the influence of~     cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant~     beneficial effect on all outcomes. It is projected that objective improvements will be~     observed following treatment with methylphenidate at both doses (10 and 20mg three time~     daily) when compared to placebo. It is further hypothesized that the effects will be~     dose-related and therefore more profound with higher doses.~   "
138335|NCT01244256|"~     The objective of this trial is to evaluate the comparative efficacy of the combination of~     Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of~     contaminated dermatosis showing bilateral symmetrical lesions.~   "
138336|NCT01244243|"~     The purpose of this study is to develop and assess the effectiveness of robot-assisted~     movement therapy in enhancing hand motor function in subjects with chronic hemiparetic~     stroke, and to identify predictors of treatment response.~   "
138337|NCT01244230|"~     Primary Objective:~      To evaluate safety (4 weeks)~      Secondary Objectives:~        -  To evaluate the long-term safety (12 weeks)~        -  To evaluate the efficacy~        -  To characterize the pharmacokinetic profile~   "
138338|NCT01244217|"~     Primary Objective:~      - To evaluate safety (4 weeks)~      Secondary Objectives:~        -  To evaluate the long-term safety (12 weeks)~        -  To evaluate the efficacy~        -  To characterize the pharmacokinetic profile~   "
138339|NCT01244204|"~     The investigators proposed a pilot study preparatory to developing a randomized trial of~     vitamin D for the prevention of TB infection. The specific aims are presented below:~        1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children~          in the schools, obtain blood samples and transport them to the United States.~        2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels~          of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages~          tested in vitro.~   "
138582|NCT01240993|"~     A formal randomized efficacy trial testing the Mothers and Toddlers' program, an~     attachment-based parenting intervention for mothers enrolled in addiction treatment and~     caring for young children.~   "
138340|NCT01244191|"~     This study is to determine if the combination regimen of ARQ 197 with erlotinib will improve~     overall survival relative to erlotinib alone in subjects with locally advanced or metastatic~     non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer~     therapies.~   "
138341|NCT01244178|"~     Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is~     a protocol for Insulin administration that involves the administration of a calculated~     higher dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp.~     It has been shown to be safe and successful in maintaining normal glucose levels.~      The objective of the study is to assess if the clamp can achieve a steady and normal blood~     glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if~     the higher insulin dose would lead to a drop in the inflammatory response seen in septic~     patients.~   "
138342|NCT01244165|"~     To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the~     treatment of pelvic organ prolapse.~   "
138343|NCT01244152|"~     The primary aim of the study is to design a group-based, culturally appropriate~     self-management skills training intervention for disadvantaged African-Americans with both~     diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The~     investigators are developing an intervention to assist individuals in reducing weight and~     hemoglobin A1c.~   "
138344|NCT01244139|"~     The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic~     profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects~     with MS.~      Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups~     (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of~     BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will~     review all safety data from previous groups enrolled, as well as data from another study~     where BIIB033 is being administered to healthy volunteers (215HV101).~   "
138345|NCT01244126|"~     The purpose of this study is to compare the difference in effect of three clinically common~     methods of providing pain medication during surgery for ventilating tubes placed for~     recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in~     a muscle, and morphine injected in a vein.~   "
138346|NCT01244113|"~     The children with CP has been shown different drug responses from the normal population of~     children and it may related with a various oral medications such as baclofen, tizanidine,~     diazepam, dantrolene, or anticonvulsant drugs.~      The aim of this study is to establish the optimal induction dose of propofol for deep~     sedation to start MRI for < 30 min in children with CP.~   "
138347|NCT01244100|"~     This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.~   "
138348|NCT01244087|"~     The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie~     (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry~     of their thoughts and beliefs connected to stressful circumstances or symptoms. This~     meditative process, named The Work, enables the participants to identify and question the~     stressful thoughts that cause their suffering. The core of IBSR is simply four questions and~     a turnaround, which is a way of experiencing the opposite of what the participant believes.~     This process is simple, powerful and can be easily implemented in daily life.~      Therefore, on the basis of previous data and beneficial observations the investigators~     postulate that the clinical utility of IBSR mediation program may improve psychological and~     physical symptoms and quality of life among BC patients during the survivorship period.~     Thus, we will conduct a pilot/feasibility randomized controlled clinical trial designed to~        -  Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and~          program satisfaction.~        -  Determine whether IBSR intervention compared with usual care is efficacious in~          improving quality of life, psychological and physical status in BC survivors.~   "
138349|NCT01244074|"~     The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual~     rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate~     its usefulness in the improvement of visual function in visually impaired patients with high~     myopia.~   "
138350|NCT01244061|"~     The main purpose of this study is to compare the effectiveness and safety of the~     re-treatment of smokers with varenicline with placebo for smoking cessation during the last~     4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain~     abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the~     end of treatment).~   "
138351|NCT01244048|"~     The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the~     modulation of cardiovascular risk factors and inflammatory biomarkers were determined.~   "
138352|NCT01244035|"~     This is a two part study comprising sequential double-dummy, placebo controlled 3-period~     randomized crossover studies. The study will evaluate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266.~   "
138353|NCT01244022|"~     Based on our previous research, this study aims to determine reliable surgical stress~     response markers in patients undergoing radical resection of colorectal cancer.~   "
138354|NCT01244009|"~     This study will investigate the efficacy and safety of MK-4827 in participants with relapsed~     mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the~     Ataxia-Telangiectasia Mutated (ATM) gene.~   "
138355|NCT01243996|"~     The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher~     than those actually recommended might increase the closure rate in preterm infants with~     gestational age <29 weeks without increasing the occurrence of associated adverse effects.~     To assess this hypothesis the investigators planned a multicenter randomized controlled~     study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose~     regimen in closing PDA.~   "
138356|NCT01243983|"~     The primary objective of this study is to assess the safety and efficacy of voclosporin as~     therapy in subjects with active noninfectious uveitis involving the intermediate and/or~     posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or~     pan-uveitis).~   "
138430|NCT01243021|"~     At Bispebjerg Hospital we have introduced an Early Warning Score based triage system ,~     called Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on~     arrival at the emergency department. The purpose of this study is to validate our triage~     system.~   "
138357|NCT01243970|"~     ECG changes during caesarean section are common. Incidence of ST depression on the ECG is up~     to 81% in some studies. Although this may indicate inadequate oxygen supply to the heart~     muscle (myocardial ischaemia) many other theories have been suggested including air entering~     the circulation from the placental bed, high heart rate, hormone or nervous system~     influences and spasm of the coronary blood supply. Perioperative ST depression often~     reflects an imbalance between heart muscle oxygen supply and demand. At the time of~     delivery, high heart rate is common and there is a further increase in the amount of blood~     the heart has to pump every minute due to blood coming back to the circulation from the~     placental bed. This increases oxygen demand and most ST changes are seen at the time of~     delivery or within 30 minutes. The clinical significance of these changes is much debated,~     and apart from a few case reports do not appear to be associated with poor heart muscle~     function or ischaemia (lack of oxygen supply). Management of the mother's blood pressure~     during caesarean section has changed greatly in recent years. Intermittent boluses of~     ephedrine, given when blood pressure is low, have been replaced with prevention of low blood~     pressure and phenylephrine has become the drug of choice. Ephedrine increases heart rate and~     contractility of the heart muscle and is likely to increase oxygen demand. Phenylephrine~     reduces heart rate while maintaining blood pressure which may result in a more favorable~     oxygen supply demand ratio.~      The investigators aim to compare the incidence of ECG changes if the mother's blood pressure~     is maintained with phenylephrine as compared to ephedrine. To see if these ECG changes are~     associated with myocardial ischaemia, the investigators will perform troponin T analysis~     after delivery. Troponin T is a molecule released by ischaemic heart muscle.~   "
138358|NCT01243957|"~     The purpose of this study is to measure if there is any difference in how the body breaks~     down or inactivates either fluoxetine or LY2216684 when both of these medicines are given~     together. This study will look at how fluoxetine might affect LY2216684 and how giving~     LY2216684 might affect fluoxetine in the body.~      The duration of study participation in this study is approximately 36 days not including the~     screening appointment. This study requires 1 research unit confinement of 29 days/28 nights~     followed by 1 outpatient appointment. A screening appointment is required within 30 days~     prior to the start of the study.~   "
138359|NCT01243944|"~     This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety~     of ruxolitinib (INC424) to Best Available Therapy (BAT) in subjects with polycythemia vera~     (PV) who are resistant to or intolerant of hydroxyurea (HU).~   "
138360|NCT01243931|"~     Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the~     depth of scars and other causes of cloudiness in the front of the cornea. The purpose of~     this study is to determine whether OCT-guided settings for the lasers used for removal of~     corneal scars and other partial-thickness corneal defects result in improved vision in~     patients receiving these procedures.~   "
138361|NCT01243918|"~     The main objective of this study is to evaluate the efficiency of the oxygen therapy~     delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems~     (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive~     use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will~     compare the successive use of systems Optiflow®/Non invasive ventilation.~   "
138362|NCT01243905|"~     The purpose of this study is to examine the effectiveness of group psychoeducation for the~     psychological distress of mothers with the children of high-functioning pervasive~     developmental disorder and for their behavior based on disorder traits.~   "
138363|NCT01243892|"~     This is a Phase IV, open label, case-controlled, observational study to evaluate the~     age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient~     (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin~     (recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to~     historical controls from the national cooperative growth study (NCGS).~   "
138364|NCT01243879|"~     Calorie restriction extends life span and prevents aging-related diseases in several~     species. Odorants from live yeast restrain the beneficial effects of calorie restriction in~     Drosophila Melanogaster. The investigators hypothesize that visual and odorous food stimuli~     impact the neuroendocrine and metabolic response to starvation in healthy humans.~      In this randomized cross-over intervention study 12 healthy, young men will fast twice for~     60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline~     and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be~     performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured~     by functional MRI.~   "
138365|NCT01243866|"~     Severe dental decay affects children physically, emotionally, socially and thereby impacts~     on their quality of life. Evidence from developed countries showed that children with severe~     dental decay weighed less than their peers and following dental treatment children's growth~     and quality of life improved. This suggests that treatment of severe dental decay may~     enhance growth and wellbeing. A study was carried out in Saudi to test that hypothesis.~   "
138366|NCT01243853|"~     The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in~     alleviating the symptoms of irritable bowel syndrome (IBS).~   "
138367|NCT01243840|"~     Purpose of the study~        1. The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in~          a Japanese population is not known. The purpose of this study is to quantify the~          predictive value of these indices in the determination of cardiovascular risk.~        2. Recently, a non-invasive method to separate the aortic pressure waveform into the~          separate ejection pressure wave and reflected pressure wave has become available. With~          this decomposition method, it is possible to estimate aortic PWV (named AVI). The~          second objective of this study is to determine if AVI can be a substitute for~          carotid-femoral PWV (cf-PWV), the current gold standard for aortic PWV measurement.~        3. To study vascular aging of the Japanese population by evaluating central blood pressure~          and aortic PWV by age, and compare these values to similar studies done in Caucasian~          and Chinese patient populations.~        4. To study the relationship between the magnitude of the aortic reflected pressure wave~          and the degree of left ventricular (LV) hypertrophy and LV diastolic function.~   "
138368|NCT01243827|"~     The purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and~     bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and~     thereby left ventricular (LV) mass in never-treated hypertensive patients.~   "
138369|NCT01243814|"~     To compare the therapeutic effect of single intra-articular injection of hyaluronate with a~     single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.~   "
138431|NCT01243008|"~     IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to~     prevent Lyme disease at early stages of infection after tick bite.~   "
138432|NCT01242995|"~     The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy~     system for the medical care of pancreatic and/or biliary disorders.~   "
138370|NCT01243801|"~     Postthoracotomy acute pain is followed by persistent postsurgical pain in 20-30% of the~     patients, defined as pain that lasts more than 3-6 months after surgery. Acute pain and~     hyperalgesia around the surgical wound are some of the risk factors associated to the~     development of chronic pain. Ketamine, as a NMDA antagonist mainly at spinal level, might~     reduce periincisional hyperalgesia and persistent postsurgical pain after thoracotomy.~     Therefore, the investigators hypothesized that continuous ketamine infusion at subanesthetic~     dose would potentiate epidural ropivacaine and fentanyl-induced analgesia after thoracotomy,~     reduce periincisional hyperalgesia and long-term postoperative pain. To test these~     hypothesis, the investigators administered a low dose of intravenous ketamine or epidural~     ketamine or placebo to patients who received an epidural infusion of ropivacaine and~     fentanyl for postthoracotomy pain.~   "
138371|NCT01243788|"~     To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs~     Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic~     Obstructive Pulmonary Disease (COPD).~   "
138372|NCT01243775|"~     Lung cancer is the leading cause of cancer death in Korea as well as in other countries.~     About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with~     NSCLC require cytotoxic chemotherapy in the course of their illness. Combination~     chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine)~     with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin,~     another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse~     effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy~     and safety of docetaxel and oxaliplatin for patients with NSCLC.~   "
138373|NCT01243762|"~     This is an open-label, two-part study to evaluate the safety and tolerability of combination~     treatment with dalotuzumab + MK-2206, dalotuzumab + MK-0752, or dalotuzumab + MK-8669~     (ridaforolimus). The study will determine the dose limiting toxicities (DLTs) observed after~     administration of each of the combinations at various doses and define the maximum tolerated~     dose of each combination. Preliminary anti-tumor activity of these combinations, in two~     groups of participants having selected tumor biomarkers, will be assessed: one group with~     metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary~     peritoneal cancer and one group with metastatic or recurrent colorectal cancer. The~     dalotuzumab + MK-8669 and dalotuzumab + MK-2206 arms will be enriched with female~     platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer~     participants. The dalotuzumab + MK-0752 arm will be enriched with metastatic or recurrent~     wild-type kirsten rat sarcoma (KRAS) colorectal cancer participants.~   "
138374|NCT01243749|"~     To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting~     Coronary Stent System in a real-world patient population requiring stent implantation.~   "
138375|NCT01243736|"~     The investigators are conducting a study to see if taking a bowel preparation before having~     a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM~     the night before a capsule endoscopy in making it easier to see the small bowel in order to~     find the source of gastrointestinal bleeding.~   "
138376|NCT01243723|"~     The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment~     of patients with dyschesia.~   "
138377|NCT01243710|"~     The purpose of this study is to determine whether taurolidine with heparin locking solution~     prevents recurrence of central venous catheter related blood stream infections in~     haemodialysis patients.~   "
138378|NCT01243697|"~     The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome,~     is a very rare genetic disorder. In contrast with healthy people, patients do not increase~     breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not~     breath sufficiently, or even stop breathing, during sleep. Their survival depends only on~     mechanical respiratory assistance, all life long.~      We have recently published two cases of recovery of a response to CO2 in patients taking~     desogestrel as a contraceptive pill. The goal of the study is therefore to assess the~     hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and~     allow them to breath sufficiently during sleep without mechanical assistance.~   "
138379|NCT01243684|"~     This study aims at evaluating spinal cord structure using diffusion tensor imaging in~     patients with cervical spondylosis.~   "
138380|NCT01243671|"~     To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for~     Japanese subjects with intestinal Behçet's disease who are refractory to conventional~     therapies.~   "
138381|NCT01243658|"~     RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine~     if oxytocin, compared to placebo shows any additional effect on the therapy achievements~     (outcome) of patients with borderline personality disorder, who receive an in-patient~     standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).~      Secondary objectives :~      Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in~     patients with borderline personality disorder. Comparison of the effects of Oxytocin on~     patients with BPD and major depression.~   "
138382|NCT01243645|"~     Background:~      Biofeedback techniques have demonstrated their uselfulness in the treatment of~     maculopathies. We wanted to evaluate the efficacy of visual rehabilitation by means of two~     different types of biofeedback techniques in patients with age related macular degeneration~     (AMD).~      Methods:~      30 patients bilaterally affected by AMD were enrolled with a mean age of 76,38±8,77 yrs.~     Patients were randomly divided in two groups: Group A was treated with an acoustic~     biofeedback, Group B with luminous biofeedback of a black and white checkerboard flickering~     during the examination. All patients underwent a complete ophthalmological examination.~     Rehabilitation consisted in 12 training sessions of 10 minutes for each eye performed once a~     week for both groups. Statistical analysis was performed using t- test. P values less than~     0.05 were considered statistically significant.~      Results:~      Group A: visual acuity at the end of rehabilitation had improved, but this result was not~     statistically significant (p=0.054), reading speed showed a significant statistical~     improvement (p=0.031), as well as the fixation stability (p=0.0023) and single point mean~     retinal sensitivity value (p=0.044).~      Group B: visual acuity improvement at the end of rehabilitation was statistically~     significant (p=0.048), reading speed showed a statistically significant improvement~     (p=0.024), as well as fixation stability (p=0.0012) and mean single point retinal~     sensitivity value (p=0.027). Final results for both groups were compared and patients in~     group B showed results which were statistically more significant.~      Conclusion:~      A contrast rich flickering biofeedback stimulus showed a statistically significant~     improvement in training the patients to modify their preferred retinal locus (PRL) in~     comparison to acoustic biofeedback. It is possible that increased involvement of the various~     retinal cell populations with visual stimuli create more efficient ganglion cell response~     that better utilize the residual retinal function.~   "
138618|NCT01240499|"~     The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES)~     approach on global health status of premenopausal overweight women preoccupied about their~     weight and who have been unsuccessful in previous weight loss attempts.~   "
138383|NCT01243632|"~     Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in~     mesothelioma patients. However, median survival of this patient group was only about 12~     months. With intent to find more effective treatment the investigators performed phase II~     study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in~     combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer~     Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore~     such regiment in patients with malignant pleural mesothelioma (MPM) as well.~   "
138384|NCT01243619|"~     The purpose of this pilot study is to develop a more advanced software program that will~     collect, compare and analyze tumor images for evaluation. Another purpose of this study is~     to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine~     (FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image~     tracking is meant to improve the visualization of tumor active and size.~   "
138385|NCT01243606|"~     Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more~     prevalent than any other class of disorders in every country in the world where surveys have~     been taken. Deepening understanding of the nature of anxiety and related emotional disorders~     during the last decade has revealed that commonalities in etiology and latent structure~     among these disorders supersedes differences. At the same time, examination of extant single~     diagnosis psychological treatment protocols (SDPs) for these disorders underscores~     mechanistic similarities. These findings suggested the possibility of distilling a set of~     psychological procedures that would comprise an innovative Unified Protocol for~     Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been~     developed. If efficacious, the UP may represent a more efficient and possibly more effective~     strategy which would render treatment implications of comorbidity, not otherwise specified~     (NOS) and subdefinitional threshold anxiety disorder conditions moot.~      The investigators now propose an evaluation of the efficacy of the UP in a group of patients~     with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence~     based SDPs benchmarked against a wait list control condition, using both statistical~     equivalence and superiority analyses. Additional aims include determining the durability of~     the UP relative to comparison conditions after treatment discontinuation, and ascertaining~     the differential impact of treatments on disorder specific symptoms vs. higher-order~     temperamental variables. Further analyses will indicate if changes in these higher order~     temperamental variables mediate long-term outcome as preliminary data suggests, and if this~     mechanism of action differs among treatments.~   "
138386|NCT01243593|"~     The purpose of this study is to evaluate the effectiveness of transversus abdominis plane~     (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty~     surgery in children.~   "
138387|NCT01243580|"~     Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be~     evaluated.~   "
138388|NCT01243567|"~     This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination~     (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never~     been previously treated and are at high risk for progression.~   "
138389|NCT01243554|"~     Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse~     pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia,~     nerve plexus injuries, increased proportion of instrumental deliveries and perineal~     ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly~     obese women) and a recent study has shown that fetuses of obese mothers develop insulin~     resistance in uterus.~      Main aims of this study are to assess if regular exercise in pregnancy among obese women can~     prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn;~     impaired vascular function in mother; insulin resistance/sensitivity; body composition in~     mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor~   "
138390|NCT01243541|"~     RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients~     receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing~     peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving~     paclitaxel.~   "
138391|NCT01243528|"~     The purpose of this trial is to determine whether nutritional status has an impact on~     nosocomial infections. Study population are patients undergoing early neurological~     rehabilitation.~   "
138392|NCT01243515|"~     The primary objective of this study is to determine whether a correlation exists between the~     Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous~     pressure (CVP), and assessment of CVP via physical examination.~   "
138393|NCT01243502|"~     K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to~     inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes~     freely into the cell membranes of keratinocytes and accumulates at a systemic level. In~     order to reduce the dermal absorption and reduce the possible long-term systemic toxicity~     this study will assess a PEGylated derivative of K-252a named CT327. This approach should~     improve the safety profile of the K-252a molecule while maintaining its activity. The~     primary objective is to assess the safety and tolerability of single and repeat doses of~     CT327 when applied topically to the skin of healthy male volunteers.~      The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics;~     PK) of CT327 following single and repeat doses in healthy male subjects.~   "
138394|NCT01243489|"~     This study on patient's compliance in clinical workaday life aims to assess and to improve~     CML treatment in Germany by means of adherence supporting measures and to increase adherence~     awareness by physicians and patients.~   "
138427|NCT01243060|"~     In recent years, there has been increased focus on cognitive side effects of sleep-inducing~     medications that may contribute to unusual behavior during unexpected awakenings during the~     night. Concerns regarding these side effects have led to a class Food and Drug~     Administration (FDA) warning for all sleep-inducing medications. Almorexant is an~     experimental sleep-inducing medication in a new class of medications that is being~     extensively developed by multiple pharmaceutical companies. Medications in this class block~     wake/arousal centers in the brain that function with proteins called hypocretins. The goal~     of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem~     (an approved sleep aid) or placebo.~   "
138395|NCT01243476|"~     Trial Design:~      This clinical trial is a phase III multicenter, randomized, double blind and controlled with~     placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme~     Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic~     syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of~     transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive~     treatment for 104 weeks until progression of the disease, which implies that the patient~     suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2~     UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable~     toxicity.~      Disease:~      Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion~     requirements.~      Total number of patients:~      In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the~     placebo branch.~      Calendar:~      First patient first visit: February 2010, and Last patient last visit expected in February~     2016. (Recruitment was initially expected to take place over a period of 24 months and was~     expected to be finished in February 2012, but due to low rate of recruitment it was extended~     until the population sample is included in the trial).~   "
138396|NCT01243463|"~     More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each~     disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric~     surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two~     conditions separately, and these treatment modalities both present a unique set of~     challenges in terms of patient-adherence. Furthermore, the combined effects of these~     therapies on body weight and OSA severity are unclear, and require longitudinal~     investigation. The purpose of the research proposed herein is twofold: A) To prospectively~     demonstrate the specific physiologic/psychological improvements in OSA risk factors and~     disease severity that occur in a subset of bariatric surgery patients with OSA, who are~     being effectively treated with PAP and furthermore; B) To elucidate differences in~     postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution)~     between patients who are compliant or non-compliant with prescribed PAP therapy. The~     investigators anticipate that results will be used to develop and streamline approaches to~     improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this~     line of research has many implications for strategies to strengthen the coordination of care~     between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral~     to the postoperative health of these patients.~   "
138397|NCT01243450|"~     The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear~     Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.~   "
138398|NCT01243437|"~     Plague is a severe, life-threatening disease. Plague occurs in focal locations worldwide,~     but over 95% of human cases reported to WHO are by countries in Africa. The most common~     clinical manifestations of human infection are bubonic, septicemic, and pneumonic plague.~     Untreated pneumonic or septicemic plague is fatal in over 90% of cases; untreated bubonic~     plague is fatal in over 50% of cases. Delayed and ineffectual treatment is a main~     contributor to elevated case fatality rates, which can be as high as 40%, and to the~     development of pneumonic plague and plague outbreaks.~      Streptomycin is considered the treatment of choice, and prompt administration can reduce~     mortality to 5% or less. However, streptomycin may cause irreversible hearing loss and~     vestibular damage, reversible renal damage, and it is contraindicated during pregnancy.~     Tetracyclines, including doxycycline, are considered effective alternatives but they are~     bacteriostatic and relatively contraindicated for use in children aged < 8 years and~     pregnant women.~      Ciprofloxacin is a relatively newer antimicrobial that is used extensively in clinical~     practice because of its broad-spectrum antimicrobial activity, excellent tissue and~     intracellular penetration, suitability for oral administration, and good overall~     tolerability. In vitro and animal studies suggest equivalent or greater activity of~     ciprofloxacin against Yersinia pestis when compared with streptomycin or tetracyclines.~     However, the efficacy of ciprofloxacin for the treatment of human plague has never been~     demonstrated, nor is it FDA approved for this indication.~      Since 2004, CDC has collaborated with the Uganda Ministry of Health (MoH) and the Uganda~     Virus Research Institute (UVRI) to enhance surveillance, diagnosis, and ecological control~     of plague in Arua and Nebbi Districts. Through these efforts, we have collected data on over~     2,400 cases of clinically diagnosed plague occurring from 1999 through 2009. In 2008, UVRI~     and CDC staff investigated 163 suspect plague cases: 57 (35%) had laboratory-confirmed~     plague illness, of which 14 patients (25%) died.~      Because plague is a relatively rare disease that mainly affects people living in rural,~     impoverished areas, it receives limited attention for research and development of affordable~     and sustainable diagnostic and treatment options. However, because plague cannot be~     eradicated, and because it causes high case fatality and has the potential for widespread~     person to person transmission, continued research should not be neglected.~      The objective of this clinical trial is to conduct a randomized, open-labeled,~     non-inferiority study comparing the safety and efficacy of ciprofloxacin to doxycycline, the~     national treatment standard in Uganda for plague, in patients aged > 8 years. The primary~     outcome for this trial will be patient outcome 14 days from enrollment and initiation of~     treatment. Patient outcome will be evaluated only for those patients with~     laboratory-confirmed plague illness.~      Information gathered from this proposed study will help optimize management of naturally~     occurring plague in humans in many countries of the world, including Uganda and the United~     States, by providing clinicians with more choices for optimal antimicrobial treatment. This~     is particularly true in resource limited rural regions such as Uganda where intravenous or~     intramuscular injections are less available. Ciprofloxacin currently is being used in Uganda~     and other plague endemic areas of the world for treatment of other infectious conditions,~     including infectious diarrhea and lower respiratory infections. In Uganda, ciprofloxacin is~     widely available in health facilities and local drug shops, and is affordable.~   "
138399|NCT01243424|"~     The aim of the study is to investigate the longterm impact on cardiovascular morbidity and~     mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g.,~     weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at~     elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.~   "
138400|NCT01243411|"~     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in~     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21~     days before the initial injection of study drug in the first treatment cycle.~      After up to four treatment cycles, each subject will be followed for additional safety and~     efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36).~      After the final injection of each treatment cycle, the investigator will model the plaque in~     an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced~     to <15° after the first, second, or third cycle of injections or if the investigator~     determines further treatment is not clinically indicated (eg, adverse events; allergic~     reaction), subsequent treatment cycles will not be administered.~      Approximately 300 subjects will be enrolled.~   "
138401|NCT01243398|"~     RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     gefitinib is more effective than a placebo in treating esophageal cancer.~      PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works~     compared with a placebo in treating patients with esophageal cancer that is progressing~     after chemotherapy.~   "
138402|NCT01243385|"~     RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block~     other enzymes needed for cell growth and stop the growth of tumor cells.~      PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as~     first-line therapy in treating patients with locally advanced or metastatic prostate cancer.~   "
138403|NCT01243372|"~     RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab~     may help doctors understand and predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in~     patients with advanced colorectal cancer.~   "
138404|NCT01243359|"~     This phase I trial studies the side effects and the best dose of sunitinib malate when given~     together with bevacizumab in treating patients with kidney cancer or advanced solid~     malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor to grow and spread. Others find tumor cells and help kill them or carry~     cancer-killing substances to them. Giving sunitinib malate together with bevacizumab may~     kill more tumor cells.~   "
138405|NCT01243346|"~     This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of~     crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.~   "
138428|NCT01243047|"~     This is a randomized phase II study comprising of two treatment arms in patients who are~     previously untreated for metastatic or recurrent colorectal cancer.~   "
138433|NCT01242982|"~     The purpose of this study is to find out the best treatment for subcapital and shaft~     fractures of the 5. metacarpal.~      It is a prospective randomized multicenter study. Comparing only fractures dislocated more~     than 30 degrees.~      One group will be operated with intramedullary pins and one group will be treated~     conservatively with reduction and then Plaster of Paris for 3 weeks.~      All patients will be followed up after 3, 6 and 12 months.~   "
138406|NCT01243333|"~     The treatment of cancer is increasingly aimed at molecular targets derived from studies of~     the oncogenes and tumor suppressors known to be involved in the development of human~     cancers. The increased specificity obtained from these new targeted treatments has developed~     over the past many decades. From the use of general cytotoxic agents such as nitrogen~     mustard in the 1940s, to the development of natural-product anticancer drugs in the 1960s~     including the Vinca alkaloids and anthracyclines there has been improvements in cancer~     chemotherapy. Early in the development process drugs were used that were found to be more~     cytotoxic to cancer cells than normal cells. Later developments included the use of specific~     monoclonal antibodies and immunotoxins targeted to cell surface receptors. In addition, as~     our knowledge of molecular biology increased, specific agents that inactivate kinases in~     growth-promoting pathways were used to treat cancer. These newer more targeted approaches~     have improved the response rate in cancer and reduced side effects of anticancer treatment~     but have not yet resulted in cures for the majority of patients with metastatic disease.~     There are general broad classifications of chemotherapeutic drug effects. One of the~     earliest and still most utilized are the cytotoxic chemotherapeutic agents.~   "
138407|NCT01243320|"~     Nanotechnology is the controlled generation and manipulation of matter in dimensions less~     than 100 nm. Silver has been used for its bactericidal properties. The investigators propose~     to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in~     human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of~     this solution.~   "
138408|NCT01243307|"~     The primary objective of this study is to compare the effect of CT327 to placebo against~     experimental induced superficial, deep and hyperalgesic pain.~      The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain~     models.~   "
138409|NCT01243294|"~     The objective of this investigation is to evaluate leakage, handling and comfort of a new~     ostomy appliance compared to SenSura.~   "
138410|NCT01243281|"~     The outcome of treatment of chronic hepatitis B is determined by viral and host interaction,~     thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug~     (entecavir) should improve the response rate. In addition, the simultaneous assessment of~     viral and host genetic factors associated with SVR may help to identify predictors of~     treatment outcomes, which will in turn significant reduce the cost/effect of therapy~   "
138411|NCT01243268|"~     This is a prospective, observational, open-label, multi-center study, which will provide~     detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive~     patients requiring combination therapy. This will present a convenient treatment option for~     hypertension in Korean patients.~   "
138412|NCT01243255|"~     The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia~     in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient~     treatment is defined as achievement of the LDL cholesterol level goals according to the~     European Society of Cardiology 2007 guidlines.~   "
138413|NCT01243242|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine~     (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD~   "
138414|NCT01243229|"~     The purpose of this study is to understand the genetic causes of congenital diaphragmatic~     disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal~     hernia.~      Specifically, the investigators plan to:~        1. Ascertain informative families and sporadic cases with congenital diaphragmatic~          disorders and obtain appropriate phenotypic data and genetic material (peripheral blood~          and/or diaphragm tissue sample).~        2. Localize the gene(s) for CDD to specific chromosomal segments using linkage analysis,~          and determine the role of somatic mutations in CDD.~        3. Isolate and characterize genes involved in the pathogenesis of CDD.~        4. Develop molecular markers that will facilitate accurate diagnosis (including prenatal~          diagnosis) and permit correlation of phenotypic variation with specific mutations.~        5. Compare RNA-sequencing from tissue samples of children without CDH to those children~          with CDH.~   "
138415|NCT01243216|"~     The investigators are interested in determining the utility of ultrasound of the spine for~     labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The~     investigators hypothesized that in women with poor spinal landmarks that the use of~     ultrasound of the spine will improve the process of placing labor epidurals or spinal~     anesthetics~   "
138416|NCT01243203|"~     The Objective of this study is to introduce a practically feasible multifaceted intervention~     in the preadmission clinic to help reduce smoking in preoperative surgical patients. The~     investigators aim to study the effectiveness of such a program in promoting positive change~     in smoking behavior among patients before surgery. The forced abstinence enforced on~     patients during hospital stay for their surgery can also be used to help smokers remain~     tobacco free long term. A significant percentage of surgical patients will be receptive to~     smoking cessation interventions in the preadmission clinic and will refrain from smoking at~     24 and 52 weeks after starting the treatment.~   "
138417|NCT01243190|"~     The goal of this clinical research study is to learn if ofatumumab can help to control~     CLL/SLL that has not yet been treated. The safety of this drug will also be studied.~   "
138418|NCT01243177|"~     Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR)~     as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy~     endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit~     balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).~   "
138429|NCT01243034|"~     The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to~     be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients~     with MS have an increased incidence of DM, coronary heart disease and increased mortality~     from cardiovascular diseases. Central adiposity is highly correlated with the presence of~     hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist~     circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD~     than either BMI or waist-to-hip ratio. However, currently there is no standard location for~     the measurement of WC.~      Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the~     iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males~     and females.~      2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.~   "
138419|NCT01243164|"~     Background and Rationale: Mobility impairment is one of the main correlates of decreased~     levels of participation in daily and social activities. Mobility disability is often~     remediable through the use of assistive technology, of which the wheelchair is arguably the~     most widely used and recognizable form. Statistics suggest over 250,000 Canadians use~     wheelchairs, the majority of whom are older adults.~      Mobility impairment often has psychological consequences that may independently restrict~     functioning and participation. Confidence is one such consequence, and according to~     Bandura's Social Cognitive Theory, is the belief individuals have in their ability to~     perform behaviours to achieve desired outcomes. Furthermore, previous findings have~     accounted for no more than 40% of the variance of factors influencing wheelchair mobility~     and participation. It is likely that confidence in wheelchair use may account for some of~     that variance. Recent findings show that approximately 40% of wheelchair users report having~     low confidence.~      Because confidence is client-specific and modifiable, treatment strategies to address low~     confidence in using a wheelchair may lead to greater participation among older adults.~      Purpose: The overall goal of this research project is to evaluate the efficacy of the~     Wheelchair Skills Training Program on confidence with using a manual wheelchair in a group~     of non-wheelchair users.~      Objectives:~        1. Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence~          with using a manual wheelchair.~        2. Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair~          performance.~        3. Explore the immediate effect of exposure to wheelchair skills (an outcome measure) on~          confidence using a manual wheelchair.~      Hypotheses:~        1. Participants who take part in the Wheelchair Skills Training Program will have~          significant improvements in confidence with using a manual wheelchair compared with~          those in the control group, as measured by the Wheelchair Use Confidence Scale~          (WheelCon)~        2. Participants who receive the Wheelchair Skills Training Program will have significant~          improvements in wheelchair performance compared to the control group, as measured by~          the Wheelchair Skills Test (WST).~        3. All participants will have significant improvements in confidence using a manual~          wheelchair after exposure to wheelchair skills (during baseline assessment).~      Research Method: This study will use 2 concurrent Randomized Controlled Trials to evaluate~     the efficacy of the Wheelchair Skills Training Program in younger and older adults. Trial 1~     and Trial 2 will employ different recruitment approaches for targeting younger versus older~     adults and different inclusion criteria with regard to age of the participants. Otherwise~     the research design, protocol and procedures will be the same. Upon completion of data~     collection, the data will be pooled and stratified by age (younger adult, older adult) for~     analyses.~   "
138420|NCT01243151|"~     The primary objective of this study is to evaluate the safety and tolerability of repeated~     doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is~     an investigational drug that is currently being studied as a lipid lowering agent.~   "
138421|NCT01243138|"~     This is a cross-sectional, epidemiological study to determine the prevalence of~     cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and~     hypertension in patients attending General Practice clinics in the Africa and Middle East~     region. A total of 4300 patients will be evaluated. In patients who are found to have~     previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or~     hypertension, the level of control of their respective conditions will also be evaluated.~   "
138422|NCT01243125|"~     NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which~     exhibits the potential to prevent the growth of urinary pathogens, including Proteus and~     others.~      The use of a catheter irrigation solution that can prevent biofilm formation and~     encrustation leading to blockage may keep the catheter patent longer, resulting in fewer~     catheter changes, potentially lower incidence of UTIs, and better patient quality of life.~      The study population will include male and female spinal cord injury (SCI) and other~     neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have~     a recent repeated history of urinary catheter encrustation and/or blockage.~      Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile~     irrigation solution and one treatment regimen with sterile saline irrigation solution. Each~     treatment regimen will consist of a total of 8 treatments, with a washout period between~     treatment regimens.~   "
138423|NCT01243112|"~     Purpose and Background The purpose of this research study is to investigate the benefits of~     mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two~     commonly used medications to numb the skin for minor procedures. Lidocaine has a faster~     onset. Bupivacaine has a longer duration. They are often combined with epinephrine to~     increase the length of action. These medications are used to control pain at the time of the~     operation and to decrease discomfort immediately afterward. Participating in the study~     involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and~     bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially~     improve the administration of these medications in persons undergoing a variety of~     procedures. You will be one of approximately 25 healthy volunteer subjects in this research~     study.~   "
138424|NCT01243099|"~     The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted~     to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is~     supported by two different observations: first, when a DES is implanted to treat a BMS~     restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly~     characterized by extracellular matrix with a regular surface. In this case stent malposition~     is less likely to occur compared to atherosclerotic lesion whose surface is often more~     irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS~     implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is~     implanted to treat restenosis, reendothelialization is likely to occur earlier. If this~     hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES~     implantation on BMS restenosis with a clinical advantage in terms of bleeding risk.~     Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES;~     thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and~     to benefit from a shorter period of dual antiplatelet therapy.~   "
138425|NCT01243086|"~     In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of~     blindness. This disease was once thought to be a natural part of aging, but recent research~     has introduced effective treatments. ARMD is related to the body initiating an immune~     response in the eye, as if responding to an infection. Vision is impacted as ocular tissue~     becomes inflamed and new blood vessels form at the back of the eye, a process called~     angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels~     and impair the eye's structure and function. Many studies have shown that ranibizumab, a~     drug that stops the formation of new blood vessels (an anti-angiogenic agent) can delay~     damage to the eye and often restore vision. The investigators believe the best drug therapy~     will also stop the inflammation. OZURDEX, a steroid drug, has shown the potential to~     effectively reduce inflammation in this application. The investigators aim to investigate if~     patients receiving a combination treatment of ranibizumab and OZURDEX improve their visual~     abilities more than those receiving just ranibizumab treatment alone. Secondarily, the~     investigators will also investigate how often patients receiving each drug therapy regime~     require re-treatment and how often they experience further vision loss.~   "
138426|NCT01243073|"~     This is a phase II open-label study of single agent imetelstat in patients with essential~     thrombocytopenia or with polycythemia vera who have failed or are intolerant to at least one~     prior therapy, or who refuse standard therapy.~   "
138436|NCT01242930|"~     This is an open label Phase II study to determine the rate of improvement in response of~     patients with previously treated multiple myeloma to imetelstat alone or in combination with~     lenalidomide maintenance therapy. This study will include multiple myeloma patients who~     either have achieved disease stabilization or who have achieved at least a partial response~     (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple~     myeloma; ie, have detectable but non-progressing disease and will most likely relapse.~   "
138437|NCT01242917|"~     This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety~     and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to~     methotrexate therapy.~   "
138438|NCT01242904|"~     Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000~     end stage renal disease patients worldwide to help replace the functions that are no longer~     performed by their kidneys. An important advantage of PD is it offers an alternative to~     hemodialysis that can be safely performed by patients in their own homes. In PD, the~     peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of~     solutes and water between the membrane capillaries and a dialysis solution that is infused~     into the peritoneal cavity. PD dialysis solutions typically require high concentrations of~     glucose to adequately perform these functions. Over time the continued exposure of the~     peritoneal membrane to high concentrations of glucose can permanently damage the membrane.~     Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that~     does not harm the peritoneal membrane. However, its use can lead to inadequate fluid~     removal. Recent research has focused on finding a PD solution, or combination of solutions,~     that will maximize the removal of toxic substances and metabolites while maintaining~     regulation of fluid and electrolyte balance in the body. A bimodal solution that combines~     glucose and icodextrin has been shown in observational studies to be effective and safe. The~     investigators propose a randomized, controlled, blinded study that will determine the~     effectiveness and safety of this bimodal fluid in a Canadian PD population. The~     investigators hypothesize that the use of the bimodal solution during the long (day) dwell~     will lead to an improvement in 24 hour ultrafiltration efficiency as compared to usual care~     using icodextrin for the long dwell.~   "
138439|NCT01242891|"~     The main purpose of this protocol is to provide a mechanism for continued access for~     patients that would have been enrolled into the primary cohorts of the IDE study.~   "
138440|NCT01242878|"~     Sickle cell disease (SCD) is an inherited disorder of the red blood cell. It is now the~     commonest genetic disorder in the UK and of childhood stroke, with up to 40% of children~     having a stroke (clinical or picked up on a scan) by school age. Patients are prone to~     develop acute crises necessitating hospital admission and resulting in long-term~     complications. Such events result in considerable morbidity, disability and mortality with~     its consequent burden on patients, families, the health service and society as a whole.~     Doctors have very little ability to predict who will get ill and when and so it is very~     difficult to known when and how to administer treatments. Furthermore there is very little~     in the way of treatments available and the mainstay of prevention is a chronic blood~     transfusion programme which is expensive, requires time off work and school and can be~     fraught with complications. This, in a population who is frequently educationally and~     socially disadvantaged at the outset. Recent evidence in sickle cell disease and other~     diseases that have similar underlying processes, points towards the importance of~     microparticles (circulating broken pieces of cells) and the coagulation system as being~     important. By comparing levels of these particles and molecules in patients with those found~     in healthy volunteers and with other measures known to be important, this study hopes to~     identify their role so as to improve the management of these patients and potentially to~     lead the way for new therapies. Participants will be required to donate a small amount of~     blood (1 teaspoon in the very young, two in older children and adults). The investigators~     aim to take this sample where possible when people are having a blood test in any case.~   "
138441|NCT01242865|"~     The present study is designed to test the feasibility and efficacy of a stand alone self~     help program for decreasing stress and anxiety and enhancing quality of life. The~     intervention will be offered in the form of a self help book and three handouts with no~     in-person instructor time.~   "
138442|NCT01242852|"~     BACKGROUND: Despite the numerous advances in the field of in vitro~     fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum~     implantation rate per embryo transferred of about 30%. Next to the physiological and physic~     burden that comes with every IVF treatment cycle, implantation failure also adds up to the~     considerable costs associated with ART. Studies have shown, that minor intrauterine~     abnormalities can be found in 11-40% of the infertile women with a normal transvaginal~     sonography. Detection and treatment of these abnormalities by office hysteroscopy have led~     to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all~     infertile women on intracavitary pathology prior to the start of IVF/ICSI.~      OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating~     unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office~     hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of~     the fertility treatment.~      STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women,~     indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.~      INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with~     treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up.~     In both groups standard IVF/ICSI treatment will be initiated.~      PRIMARY OUTCOME MEASURE:~      Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of~     IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh~     embryos, as well as in subsequent cryo/thaw cycles)~      SECONDARY OUTCOME MEASURE:~        -  Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after~          randomization (obtained in both treatment cycles with fresh embryos, as well as in~          subsequent cryo/thaw cycles)~        -  Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization~          (obtained in both treatment cycles with fresh embryos, as well as in subsequent~          cryo/thaw cycles)~        -  Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment~        -  Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy~          procedure~        -  Prevalence of unexpected intrauterine abnormalities~        -  Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities~   "
138472|NCT01242449|"~     This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks~     intervals in combination with trastuzumab as 1st and 2nd line treatment of women with~     metastatic HER2 positive breast cancer.~      Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic~     breast cancer, and capsules are generally better tolerated.~   "
138503|NCT01242033|"~     Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries,~     or two slices white bread with or without 200 mg vitamin C, after an overnight fast and~     consumption of a low polyphenol diet for two days. Blood samples will be taken at various~     time points over an eight hour period to measure oxidative stress and antioxidant levels in~     the blood. Each subject will attend 5 study visits with one week intervals and be given each~     meal in a random order. It is hypothesized that raspberry consumption at higher doses will~     greater protect against meal-induced oxidative stress compared to bread controls.~   "
138443|NCT01242839|"~     CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as~     heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the~     matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or~     endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective~     function and restores the matrix architecture. This produces a suitable spatial environment~     for cells to respond properly to the cascade of signals needed for tissue regeneration to~     resume.~      The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both~     locally and generally, as proved by a pilot study which as been conducted at the Hôpital~     des XV-XX in Paris (France). It reduces the pain significantly and increases corneal ulcer~     healing (all ulcers treated were resistant to all other usual therapies).~      Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the~     efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and~     will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3~     months.~      The aim of the study is a double blinded comparison of complete chronic corneal ulcers~     healing rate within 3 months in 3 groups of patient double blinded randomized between~     CACICOL20 instillations distribution and physiological salt solution instillations~     distribution.~      The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete~     closure.~   "
138444|NCT01242826|"~     This trial is conducted in Asia. The aim of this clinical trial is to investigate the~     pharmacokinetic properties (the rate at which the trial drug is eliminated from the body)~     after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp~     50). In addition, the safety and tolerability of BIAsp 50 will be observed~   "
138445|NCT01242813|"~     This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent~     or chronic TNF-receptor associated periodic syndrome (TRAPS).~   "
138446|NCT01242800|"~     RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative~     surgery or radiation therapy may help patients with advanced breast cancer live more~     comfortably. It is not yet known whether early surgery is more effective than palliative~     therapy for advanced breast cancer.~      PURPOSE: This randomized phase III trial is studying early surgery to see how well it works~     compared to standard palliative therapy in treating patients with stage IV breast cancer.~   "
138447|NCT01242787|"~     The purpose of the study is to investigate the long-term safety and the antiviral activity~     of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with~     chronic hepatitis B infection compared to entecavir 0.5 mg.~   "
138448|NCT01242774|"~     This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat~     given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with~     induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a~     cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of~     the combination in this regimen.~   "
138449|NCT01242761|"~     After comparing ultrasound study of rotator cuff injuries that have been evaluated both in~     the community and in a hospital-based ultrasound service with actual surgical findings, it~     is expected that specialist performed imaging and evaluation will be most accurate and that~     those performed in the community will be not accurate enough.~   "
138450|NCT01242748|"~     A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot~     with the established therapy Zoladex 3 month implant in patients with prostate cancer.~   "
138451|NCT01242735|"~     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise~     intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing~     symptoms. The investigators expect that this project will contribute much needed knowledge~     about the role that aerobic exercise can play in managing the effects of OCD. If~     moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage~     obsessions and compulsions, this will establish that aerobic exercise may be a valuable~     adjunct to other OCD treatments such as medication and therapy.~   "
138452|NCT01242722|"~     This study will collect data, from an implanted Cardiac Resynchronization~     Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart~     failure devices.~   "
138453|NCT01242696|"~     The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European~     Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the~     TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.~   "
138454|NCT01242683|"~     Physician-based primary care has thus far failed to address the obesity epidemic. In this~     randomized clinical trial of 200 obese patients with heart disease risk factors, the~     investigators will evaluate the impact of nurse and dietitian case management on weight loss~     and weight maintenance, as an adjunct to physician care. In addition, the investigators will~     test the incremental benefit of an environmental support strategy using community health~     workers to help patients navigate their home and neighborhood environments to achieve weight~     loss. The innovative intervention model developed and evaluated in this project has the~     potential to provide a blueprint for successful primary care-based obesity services~   "
138455|NCT01242670|"~     The purpose of the study is to verify the safety and adequacy of the immune response~     produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV)~     vaccine and to demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.~   "
138488|NCT01242241|"~     Obesity in children,as in adults,has rapidly become a public health concern. Studies in~     adults have shown that obesity, now considered to be a disease state, is a modifier of the~     effect of drugs on the body as well as how the body handles the drug.The anesthetic~     management of obese children poses a variety of significant challenges which include~     determination of the appropriate dose of anesthetic intravenous agents. Dosing of most drugs~     is calculated based on the effective dose in 50% of patients but the more practical and~     required information is the effective dose in 95%(ED95%)of patients. The aim of this study~     is to determine the effective dose in 95% of patients(children). The hypothesis is the ED95~     of propofol in obese children will be higher than that of non-obese children.~   "
138489|NCT01242228|"~     This study is to evaluate long-term safety and efficacy after concomitant administration of~     ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.~   "
138456|NCT01242657|"~     The long term goal of the study entitled Quit & Fit was to revise, evaluate, and~     disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not~     On Tobacco (N—O—T), with an added physical activity module. The physical activity module was~     intended to encourage youth to adopt a more physically active lifestyle. Research showed~     that physical activity may increase the odds of smoking cessation. The general N—O—T program~     goals are to help adolescents quit smoking; reduce cigarette use (for participants who are~     unable to completely quit); increase healthy lifestyle behaviors; and improve life skills~     such as stress management, decision making, communication, and interpersonal skills. The~     primary aim of the current research project was to reduce smoking among West Virginia teens.~     A two—prong secondary aim was to (a) increase participants´ physical activity behavior by~     supplementing the intervention with a physical activity component and (b) assess the~     mediating/moderating impact of physical activity on cessation outcomes. If participants quit~     smoking, the likelihood that they will develop smoking—related diseases is diminished.~     Participating in this project may aid smoking cessation and therefore improve participants´~     health. Research was conducted among 19 of the 123 West Virginia public high schools. 236~     teens were recruited to participate in the study over 3 years. This study is a clinical~     behavioral trial using a 3-group design, with subsequent random assignment.~   "
138457|NCT01242644|"~     Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as~     effective as this solution plus ropivacaine administered intra-articularly for twenty-four~     hours.~      Three groups were assigned random patients, each group provided a different method of pain~     medication in order to determine the effectiveness of each treatment.~   "
138458|NCT01242631|"~     The purpose of this study is to determine whether the drug everolimus is effective in the~     treatment of patients with relapsed cancer of the testis. This is a phase II study where all~     patients will receive the study drug (everolimus 10 mg daily). The primary endpoint of the~     study is the rate of patients that have no progressive disease after 12 weeks of treatment.~     Twenty-five evaluable patients will be treated in this study.~   "
138459|NCT01242618|"~     The purpose of this study is to investigate the safety and feasibility of implanting an~     engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes~     within a collagen type I/III membrane, in the alar lobule of patients after resection of a~     non melanoma skin cancer.~   "
138460|NCT01242605|"~     The objective of this study is to establish the recommended dose of selumetinib, a novel MEK~     inhibitor for use in combination with gemcitabine and cisplatin.~   "
138461|NCT01242592|"~     The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti~     tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of~     relapsed Pulmonary TB.~   "
138462|NCT01242579|"~     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine~     and maraviroc gel and determine whether it is safe for daily use by healthy women in the~     United Kingdom~   "
138463|NCT01242566|"~     The management of glioblastoma in elderly patients with poor performance status (KPS<70) is~     unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and~     safety of temozolomide alone in this population~   "
138464|NCT01242553|"~     To demonstrate clinical substantial equivalence of iVue as comparable to commercially~     available RTVue.~   "
138465|NCT01242540|"~     Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI)~     investigations of pain have provided substantial insight into the workings of the human~     brain. To date, however, the vast majority of studies have dealt with short painful~     stimulations. This work will expand the investigators knowledge of how longer stimulations~     are processed by comparing the activation pattern from a two minute painful stimulation with~     that of an 30-second painful stimulus. The investigators hypothesis that accommodation to~     the longer stimulation will be evident by either decreases in signal intensity in brain~     areas known to process pain, or by increasing activity in brain areas thought to be~     responsible for the modulation of painful perception.~   "
138466|NCT01242527|"~     The primary objective of the study is to determine the efficacy of Epanova (omefas) compared~     to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.~   "
138467|NCT01242514|"~     The purpose of this study is to evaluate the long term safety and tolerability of~     fostamatinib in patients with rheumatoid arthritis (RA).~   "
138468|NCT01242501|"~     This is a Phase IIB randomized trial to test a brief single session risk reduction~     counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa.~   "
138469|NCT01242488|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and~     immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who~     have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.~   "
138470|NCT01242475|"~     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum~     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a~     positive test result will show as redness and/or swelling at the injection site, while a~     negative test will leave no reactions.~      The aim of this study is to test the C-Tb skin test in healthy adults previously BCG~     vaccinated to determine if healthy non tuberculosis infected individuals has a truly~     negative test result (this is called determining the specificity of the skin test). To be~     able to compare the new skin test with the current Tuberculin skin test volunteers will be~     injected with both the C-Tb and the TST skin test.~   "
138471|NCT01242462|"~     Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm~     infants. Despite improved survival of extremely premature infants with RDS, complications~     related to mechanical ventilation still occur. This trial will attempt to maintain adequate~     gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak~     inspiratory pressure in infants with respiratory distress requiring mechanical ventilation.~     A cross over design will be used to test the hypothesis whether mid-frequency ventilation in~     preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory~     pressure requirement when compared to conventional mechanical ventilation.~   "
138490|NCT01242215|"~     This study is to evaluate the efficacy and safety after concomitant administration of~     ASP1941 and sulfonylurea in patients with diabetes mellitus.~   "
138473|NCT01242436|"~     Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the~     diagnosis is often been made in an advanced cancer stage with metastases throughout the~     peritoneum.~      An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for~     the first time that patients in such an advanced stage of ovarian cancer who received first~     three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking~     surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had~     fewer complications than patients treated with primary debulking surgery followed by~     chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The~     most important prognostic marker appeared to be whether patients with primary or interval~     surgery no longer had a visible residual tumor after the treatment. Patients who had only~     small metastases in the peritoneum, seemed to be better treated with primary surgery~     (neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian~     Crystallising, N Engl J Med 363 (1910): 943 - 953).~      Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation~     where they assess which of the two treatments is the best option.~      The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a~     non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal~     metastases. This is to assess which of the two treatments (primary debulking surgery~     followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval~     debulking surgery, followed in turn by chemotherapy) is the best option for a particular~     type of patient.~   "
138474|NCT01242423|"~     The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the~     healing of second-degree burns as well as skin-graft donor sites.~      In both cases, the primary hypothesis is the shortened period leading up to the complete~     healing of the wound (reepithelization).~      The secondary hypothesis in the course of the study assesses:~      the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).~   "
138475|NCT01242410|"~     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth~     in pregnant women with twins and a short cervical length at 18-22 weeks scan.~   "
138476|NCT01242397|"~     The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in~     patients with severe functional MR (Mitral Regurgitation) who are not currently indicated~     for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and~     ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these~     patients.~   "
138477|NCT01242384|"~     Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth~     in pregnant women with short cervical length after an episode of threatened preterm labour.~   "
138478|NCT01242371|"~     The investigators intend to explore the hypothesis that symptoms of schizophrenia may be~     reduced by the administration of a probiotic supplement when used in addition to standard~     antipsychotic medications.~   "
138479|NCT01242358|"~     In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may~     occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an~     additional capnographic monitoring is subject of the study.~   "
138480|NCT01242345|"~     In this randomized controlled trial the utility of capnography and IPI gets evaluated.~     Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be~     prevented by an additional capnographic monitoring is subject of the study.~   "
138481|NCT01242332|"~     To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL~     reconstruction~   "
138482|NCT01242319|"~     This quality improvement trial aims to evaluate whether giving patients information about~     their coronary heart disease risk via a computer kiosk in the doctors waiting room and~     providing primary care doctors with a personal digital device with a decision support tool~     to help with cholesterol management will improve cholesterol management compared to usual~     care.~   "
138483|NCT01242306|"~     This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs~     SES, both implanted in the same patient with multiple de novo coronary artery lesions~     undergoing elective PCI. The primary end point will be the evaluation of endothelial~     dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of~     the stent and peri-stent site after infusion of acetylcholine.~   "
138484|NCT01242293|"~     The purpose of this study is to determine that maternal hydration during labor with fluids~     containing glucose at a rate of 125 ml per hour does not affect the duration of labor~     compared to Ringer Lactate at a rate of 250 ml per hour.~   "
138485|NCT01242280|"~     In the last years, important advances have been done in the treatment and prevention of~     esophageal variceal bleeding. Experts agree that the combination of pharmacological and~     endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas~     TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy.~     Nevertheless, some patients would require different therapies to act as a bridge until~     definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube)~     represents, up to now, the most widely used temporary bridge to TIPS. However, balloon~     tamponade is associated with a high incidence of serious adverse events. Recently, the use~     of self-expanding metal stents have been introduced in the treatment of acute variceal~     bleeding showing a very high hemostatic efficacy with no adverse events. The present study~     is directed to compare the efficacy free of adverse events and mortality of self-expanding~     metal stents vs balloon tamponade in patients with variceal bleeding refractory to medical~     and endoscopic therapy.~   "
138486|NCT01242267|"~     The primary objective of this study is to:~      • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense~     melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of~     patients who failed a prior treatment with dose-intense melphalan~      The secondary objectives of this study are to:~        -  Determine the toxicities resulting from administration of combinations of thalidomide,~          bortezomib and melphalan~        -  Determine the complete response (CR) and very good partial response (VgPR) rate in~          patients undergoing ASCT using thalidomide, bortezomib and melphalan~        -  Evaluate the treatment-free interval after treatment with the combination of~          thalidomide, bortezomib and melphalan~   "
138487|NCT01242254|"~     This study is designed to assess the efficacy and safety of multiple intravitreal injection~     of KH902 in patients with CNV due to AMD.~   "
138493|NCT01242163|"~     Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD),~     especially with mild disease activity, is common clinical challenge. Most of the patients~     with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to~     avoid invasive investigations, there is a search for noninvasive markers with the capacity~     to distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering,~     Technion) developed a system that combines nano-metals produced in his laboratory with~     electrical devices (transistors). The combination between a nanomaterial and an electrical~     transistor induces a change in its electrical behavior upon exposure to the material being~     examined; that is, a change in its electrical properties. The change in its electrical~     behavior is translated into a computerized graphic signal.~      The electronic nose is composed of an air pump, a filter for filtering external contaminants~     and an array of sensors. Each sensor transmits a signal according to the materials it~     knows how to identify. Thus, it is possible to characterize most of the substance families~     characteristic of a certain disease, and the same system is designed for differential~     diagnosis of different diseases.~      The purpose of the investigators study is to use the electronic nose to find bio-markers~     that will help to diagnose IBD and IBS without using invasive procedures.~      The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50~     controls). The patients included in the study will undergo an evaluation by a~     gastroenterologist after signing an informed consent and will answer a questionnaire.~      The samples will analyzed in the laboratory of Dr. Haick.~   "
138494|NCT01242150|"~     In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive~     Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related~     complications such as tracheal injury and predisposition to nosocomial pulmonary infections.~     The choice of the interface is one of the crucial issues affecting treatment outcome in~     pediatric age and in particular in preschool children in whom intolerance frequently~     compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or~     facial tight fitting masks and the most important principle in guiding the selection of an~     interface is that it should fit comfortably. However, while nasal mask can leak gas when the~     infant opens his/her mouth, facial mask can cause significant gastric distension and~     vomiting, with risk of aspirating gastric contents. Moreover, complications such as air~     leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or~     facial masks in children frequently lead to interruption of the respiratory treatment. Thus,~     improving the interface between the patient and the ventilator would be expected to~     facilitate longer and more effective application of NCPAP.~      A new small helmet specifically designed for young infants has been recently introduced to~     administer NCPAP. In a recent short term crossover physiological randomized controlled~     trial, the investigators found that NCPAP by helmet was associated with enhanced~     feasibility, less need of sedation and prolonged application time (see references below).~     The purpose of this prospective randomized multicenter study is to compare the efficacy and~     feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory~     failure in infants admitted to Pediatric Intensive Care Unit (PICU).~   "
138495|NCT01242137|"~     Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form.~     Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs~     from the sulfonylurea drug family, to whom Glibenclamide is included.~      The investigators assumption is that patients with less active alleles of the enzyme may~     show lower dose requirements of the drug for glycemic control, when compared to patients~     homozygotes to wild-type alleles.~   "
138496|NCT01242124|"~     The purpose of this study is to determine the safety and efficacy of the side-to-side~     stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.~   "
138497|NCT01242111|"~     This multicenter, open-label extension study is designed to assess long-term efficacy and~     safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with~     Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin~     sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were~     eligible to enroll in this study (except patients who enrolled in NCT01275066; Study~     Identification Number MOR-004).~   "
138498|NCT01242098|"~     The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol~     (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to~     fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients~     switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared~     with patients not switched.~   "
138499|NCT01242085|"~     The hypothesis of this study is that total knee alignment will be improved by preoperative~     planning from CT scans and the production of custom instruments compared to the use of~     standard instruments.~   "
138500|NCT01242072|"~     This an an open-label study to define the safety profile and the maximum tolerated dose and~     confirm the clinical effective dose of palifosfamide-tris given intravenously in combination~     with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin~     are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II~     study using the 3 agents combined will begin.~   "
138501|NCT01242059|"~     It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,~     subjective appetite and glycemic response.~   "
138502|NCT01242046|"~     The key research question in this study is whether or not caffeine facilitates genital~     sexual arousal in women in the presence of an external erotic stimulus. Caffeine's impact on~     the human sexual response cycle has yet to be studied in the field, so the goal is to~     determine if this substance will have any impact on genital arousal well as potentially~     identify the mechanisms underlying its ability to do so. Considering that this will be a~     single blind study, a key goal of the project is to determine how participant expectations~     regarding what they ingest will impact their subjective sexual arousal. At present, we~     hypothesize that, as caffeine's stimulant properties increase a human's heart rate and blood~     pressure, caffeine intake will facilitate genital arousal.~   "
138531|NCT01241669|"~     This is a drug-drug interaction study to evaluate the effects of steady-state exposure of~     E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation~     transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of~     E5555 on several renal function parameters.~   "
138504|NCT01242020|"~     The purpose of this study is to test a method of imaging (taking a picture) of the abdomen~     (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a~     drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound~     waves to create a picture of the inside of the human body. Two sets of pictures will be~     taken on two different days to see if the results are the same each time.~      DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA~     to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking~     pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood~     vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of~     DEFINITY® is different than the use approved by the FDA, this study will be performed under~     an FDA Investigational New Drug (IND) application.~   "
138505|NCT01242007|"~     Myotonic dystrophy Type 1 (MD1, Steinert's disease), an autosomal dominant multisystem~     disease, is of the most common muscular dystrophies in adults, with a European prevalence of~     3-15/100 000. The disease course is progressive, associating muscular weakness, wasting and~     myotonia. Respiratory dysfunction is common, involving a restrictive ventilatory abnormality~     and alveolar hypoventilation, originating from respiratory muscle weakness. Depending on the~     degree of impairment of their lung function, the quality of life and the prognosis of MD1~     patients may be very variable. However, time course and prevalence of such respiratory~     function impairment have not been clearly identified. More importantly, factors able to~     predict poor respiratory outcome have not been defined and therefore early prognosis can not~     be assessed during the follow-up of these patients. In other neuromuscular disorders,~     especially Amyotrophic Lateral Sclerosis (ALS), postural spirometry has been recommended to~     improve the detection of diaphragmatic involvement and some authors have suggested that the~     supine fall in the forced vital capacity could be used to initiate noninvasive positive~     pressure ventilation and predicts some respiratory symptoms.~      In a sample of ambulatory patients with MD1, our study was designed to prospectively achieve~     two aims: 1) to assess the respective prevalence of a ventilatory restrictive pattern,~     respiratory muscle weakness, hypoxemia and hypercapnia and 2) to evaluate whether postural~     changes in lung volumes contribute to sensitize the diagnosis of respiratory weakness and~     could be used as a predictor of poor respiratory function, including hypoxemia, hypercapnia~     and restrictive ventilatory disease.~   "
138506|NCT01241994|"~     AASD is a new dialysis technique based on the use of a mathematical model of intradialytic~     solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and~     ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile~     is to obtain the higher stabilization of intradialytic extra cellular compartment, in~     consideration of end session targets: body weight and final patient's natremia. In this~     multicenter prospective controlled randomized trial the primary end-point is the clinical~     efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps,~     headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).~   "
138507|NCT01241981|"~     This study will examine a new imaging technique called digital breast tomosynthesis (DBT)~     compared to standard mammography in women under 60 presenting with signs of breast cancer.~     The reason that we need to do this study is that standard mammography fails to detect the~     cancer in approximately 20% of these women because younger women have denser breast tissue.~     We hope that DBT will be more sensitive in detecting breast cancer than standard~     mammography.~   "
138508|NCT01241968|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of~     patients with refractory angina not amenable to revascularization with angioplasty or bypass~     surgery.~   "
138509|NCT01241955|"~     To compare the decision making of family members of patients admitted to the ICU in regards~     to their CPR preferences for their loved ones with and without the use of a video decision~     aid.~   "
138510|NCT01241942|"~     The purpose of this research study is to perfect the technique of EVLP and learn about the~     safety of transplanting lungs that have been ventilated (attached to a breathing machine or~     ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™,~     made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo)~     in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most~     heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is~     to learn how well the lungs work, and whether they are likely safe to transplant.~   "
138511|NCT01241929|"~     To compare the decision making of subjects with advanced cancer having a verbal advance care~     planning discussion compared to subjects using a video.~   "
138512|NCT01241916|"~     Primary Question: When splinting is used to improve motion in post-traumatic stiff elbows,~     is there a significant difference in gains in motion achieved between static progressive or~     dynamic splint approaches?~      Secondary Question: Is there a significant difference in patient compliance with static~     progressive versus dynamic splint use, and does this effect final ulnohumeral motion~     outcomes?~   "
138513|NCT01241903|"~     The central hypothesis for this work is that platelet - leukocyte interactions play a~     critical role in the pathogenesis of acute ischemic events. The primary objective of the~     study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor~     rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary~     intervention exerts beneficial vascular effects by reducing platelet - leukocyte~     interactions.~   "
138514|NCT01241890|"~     Pulmonary exacerbations of CF are an important cause for the experienced disability of~     patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic~     therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is~     important. The aim of this study was to assess the predictive properties of inflammatory~     markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the~     reliability of home monitor assessments of symptoms and lungfunction was investigated.~   "
138545|NCT01241474|"~     The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of~     marine oil improves insulin sensitivity and glucose control in subjects with impaired~     glucose regulation.~   "
138546|NCT01241461|"~     The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese~     patients with advanced and/or metastatic solid tumors for which no proven effective therapy~     exists.~   "
138515|NCT01241877|"~     Background of the study:~      Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown~     in animals and humans. Exercise enhancing effects have been shown in animals via enhancement~     of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation~     on fat oxidation and cycling performance in trained cyclists~      Objective of the study:~      To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat~     oxidation and improve exercise performance in trained cyclists~      Study design:~      Double blind, placebo controlled study.~      Study population:~      Well trained cyclists between 18-30 years old~      Intervention (if applicable):~      astaxanthin (20 mg/day) or placebo for 4 weeks~      Primary study parameters/outcome of the study:~      performance on a time trial after 90 min steady state exercise.~      Secundary study parameters/outcome of the study (if applicable):~      substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness (if applicable):~      The risks involved in participating in this experiment are minimal. Astaxanthin has been~     shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw~     and the only risk is of a small local haematoma.~   "
138516|NCT01241864|"~     The purpose of this study is to learn about the safety of islet transplantation when~     performed after kidney transplantation, which may provide more normal control of blood sugar~     without the need for insulin shots. Islets are special clusters of cells within the pancreas~     that produce insulin. These cells will be obtained from cadaver (non-living) donors and~     given to subjects by vein.~   "
138517|NCT01241851|"~     To determine whether acute aerobic exercise versus resistance exercise effects cognitive~     function among older adults.~   "
138518|NCT01241838|"~     The purpose of this study is to compare the effect of heart rate on cardiac index in~     patients with or without left ventricular hypertrophy. The study will be conducted in~     postoperative heart surgery patients with a pacemaker.~   "
138519|NCT01241825|"~     The purpose of this study is to see if chewing sugarless chewing gum alters the time it~     takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if~     more/less capsule endoscopes reach the large bowel.~   "
138520|NCT01241812|"~     High joint load during walking has been linked to cartilage degradation. Biomarkers, found~     in the blood and urine, are protein fragments released after cartilage degradation~     characteristic of OA. They have the potential to enable direct and immediate disease state~     monitoring and identification of early cartilage changes. Little is known about the~     association of biomarkers with joint load or if exercise aimed at reducing joint load~     changes biomarker levels, thus reducing the risk of OA progression. This study will provide~     novel information on these relationships and will guide future intervention studies. The~     investigators hypothesize that certain biomarkers will be highly correlated with joint~     loading during walking and that the levels of these biomarkers in the blood and urine will~     decrease following an exercise intervention aimed at cartilage unloading.~   "
138521|NCT01241799|"~     Purpose:~      To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration~     biopsy (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in~     place within the biopsy needle.~      Hypothesis:~      In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle~     aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield~     compared to those with the internal stylet.~      Justification:~      EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within~     the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive~     procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling~     suspected cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions,~     peripancreatic, perigastric or mediastinal lymph nodes and in some cases adrenal or liver~     masses. Therefore, it is a powerful tool for both diagnosis and tumour staging. For example,~     for the diagnosis of pancreatic adenocarcinoma, which is a common indication for EUS-FNA,~     the sensitivity varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of~     85%. Improving the diagnostic yield may lead to an earlier diagnosis with a reduced number~     of investigations and earlier institution of treatment for the patient.~      The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle~     piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope.~     The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle~     easily seen. The sample is taken by inserting a specially designed needle into the area of~     interest under EUS guidance. Inside the needle is a removable stylet with a rounded or~     bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is~     for the stylet to be extracted after the needle has been passed into its optimum position~     within the tissue and for it to be re-inserted before each pass. However, a recent~     prospective trial with 111 patients, published in abstract form, found this approach was~     associated with a significant reduction in the proportion of adequate samples compared to~     when the stylet was removed before passing the needle. Although there was no significant~     difference in the diagnostic yield between the two groups this study raises the issue that~     the stylet left in place is to the detriment of the tissue sample and, ultimately, may~     reduce the diagnostic yield or increase the number of passes needed to obtain a satisfactory~     sample.~      One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA~     vary considerably depending on the type of tissue being biopsied. The second limitation is~     that consecutive patients were randomized to having the stylet removed versus having the~     stylet not removed at the time of FNA. There is no control group from which to compare the~     two groups. An improvement in the study design would be to have each patient to be their own~     control group. Successive passes of the FNA needle can increase the bloodiness of the~     sample, so randomization of the order in which each group is done will help eliminate~     potential bias.~      It is clear from the current published literature that removing the stylet increases the~     cellularity of the sample. However, this increased cellularity may be the result of more~     contamination from the GI tract through which the FNA needle needs to pass in order to get~     an extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity~     that can compromise diagnostic accuracy.~      Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to~     interpret. A preliminary result based on an air dried slide often can lead to fewer FNA~     passes if a diagnosis can be made. If this is not possible, a cell block preparation is made~     from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy~     of these two types of samples using an EUS-FNA needle with and without the stylet within the~     same patient.~      Objectives:~      To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from~     the FNA needle compared with leaving it in place.~   "
138522|NCT01241786|"~     To determine the response to the combination of azacitidine + lenalidomide in patients with~     relapsed/refractory CLL and SLL~      Hypothesize - lenalidomide's activity in combination with azacitidine may further enhance~     its activity and the durability of treatment response.~   "
138523|NCT01241773|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the steady-state pharmacokinetics of efavirenz or raltegravir , and vice versa.~     Steady state is a term which means that the drug has been given long enough so that the~     plasma concentrations will remain the same with each subsequent dose. TMC435 is being~     investigated for the treatment of chronic hepatitis C virus (HCV) infection. Efavirenz and~     raltegravir are two antiretroviral drugs for treatment of human deficiency virus (HIV)~     infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,~     distributed in the body and eliminated from the body.~   "
138524|NCT01241760|"~     The purpose of this study is to evaluate the effectiveness of telaprevir administered twice~     daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in~     treatment-naïve participants with chronic HCV genotype 1 infection.~   "
138525|NCT01241747|"~     Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in~     exercise performance, peripheral vascular function, and health-related quality of life than~     compared to the attention-control group.~      Hypothesis #2. The change in peripheral vascular function will be predictive of improved~     exercise performance following the supervised exercise program.~   "
138526|NCT01241734|"~     The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the~     patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the~     RICE therapy and again after transplant as maintenance. To improve over all outcome and~     survival.~      Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall~     response rate thus increasing the number of patients able to proceed with autologous stem~     cell transplant. This in turn may translate into improved overall survival and progression~     free survival.~   "
138527|NCT01241721|"~     The purpose of the study is to determine the optimal, lowest dose of radioactive tracer~     required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in~     pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating~     breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.~   "
138528|NCT01241708|"~     High dose chemotherapy with stem cell transplantation is commonplace in the treatment of~     multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been~     used in several thousand bone marrow transplant recipients worldwide for the same or similar~     disorders.~   "
138529|NCT01241695|"~     The purpose of the study is to determine the safety, acceptability and the efficacy of a~     12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic~     control in type 2 diabetic patients with or at risk of malnutrition~   "
138530|NCT01241682|"~     Earlier the investigators determined the safety and feasibility of tumor lysate-pulsed~     dendritic cells as therapeutic adjuvants in mesothelioma patients. Because pre-clinical data~     in mice had shown that better results were obtained when regulatory T cells were depleted~     using low-dosis of cyclophosphamide, ten patients who responded on chemotherapy are selected~     for DC-treatment in combination with Endoxan.~   "
138532|NCT01241656|"~     In this study we will compare 3 strategies for systematic delivery of prostate cancer~     screening decision support interventions (DESI) to usual care and examine their impact on~     screening decisions and subsequent healthcare utilization using a randomized control design.~      We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies~     will be less likely to opt for prostate cancer screening, and will have lower subsequent~     healthcare utilization than men in the control group.~   "
138533|NCT01241643|"~     This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly~     doses of Interleukin-7 (CYT107)~   "
138534|NCT01241630|"~     Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder~     dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for~     bladder dysfunction in SCI has been introduced. The concept is promising, not just for~     bladder but also for bowel dysfunction. However, well designed studies need to be performed~     before recommending the procedure to a large number of patients worldwide. In this study we~     perform multidisciplinary studies providing necessary information about the clinical outcome~     of the somato-sensory reflex arch in adult SCI patients.~      The hypothesis is as follows:~        1. In a western setting the somato-sensory reflex arch can be created in adult SCI~          patients with only minor morbidity and complications.~        2. Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.~   "
138535|NCT01241617|"~     The objective of this study is to confirm superiority between a test treatment group using~     Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international~     standard of care group using a conventional stapler in patients undergoing pulmonary~     lobectomy surgery, using a randomized comparative study of the frequency of intraoperative~     air leak.~   "
138536|NCT01241591|"~     To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of~     CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.~   "
138537|NCT01241578|"~     Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are~     highly variable, and patients sometimes fail to achieve a successful weight loss of 5-10%~     of their starting weight. It has been suggested that the one size fits all approach of SBT~     may be responsible for many treatment failures because the intervention is not sufficiently~     tailored to address the unique needs of each patient. Moreover, treatment is delivered in~     the clinic, not in the settings and the times when it is needed most. The primary aim of the~     proposed research is to develop and pilot test a behavioral weight loss intervention that~     combines in-person sessions with treatment delivered via an electronic handheld device to~     provide highly individualized weight loss treatment in patients' natural environment. In a~     critical departure from previous research using cell phone technology, the portion of~     intervention that is delivered via handheld device will be of equal sophistication and~     importance to the portion of the intervention that is delivered in face-to-face treatment~     sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of~     an individually tailored behavioral weight loss program that integrates clinic-based care~     and smartphone technology.~   "
138538|NCT01241565|"~     The objectives of this clinical trial are to compare the incidence and duration of air leaks~     and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic~     Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in~     a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).~   "
138539|NCT01241552|"~     This study will investigate whether: 1) treatment with MK-3415A in addition to standard of~     care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence~     as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or~     MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to~     placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in~     participants receiving SOC therapy for CDI as compared to placebo.~   "
138540|NCT01241539|"~     The current study will allow the assessment of pharmacokinetics, pharmacodynamics,~     elimination rate and clearance of dabigatran etexilate during and following haemodialysis in~     ESRD patients.~   "
138541|NCT01241526|"~     The goal of the study is to evaluate a Home-Based Disease Management program specifically~     developed for patients with Gold III/IV COPD.~      By improving disease knowledge, awareness of significant clinical deterioration and~     self-management skills for patients, this Home-Based COPD Management Program is expected to~     reduce the severity of exacerbations, the need for emergency hospitalisations, thus~     demonstrating the efficacy and the cost effectiveness of this intervention.~   "
138542|NCT01241513|"~     The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can~     increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is~     approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol~     overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In~     this study, the FDA-approved form of ACCY will be used off-label (meaning in a way not~     approved by the FDA).~      This study is being conducted by researchers from the United States Army Research Institute~     of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber~     located in the basement of USARIEM. A total of approximately 30 volunteers (men and women,~     military and civilians) will take part in the study. They can expect to be in the study for~     a minimum of a few hours each day for two weeks.~      The investigators hypothesize that ACCY will improve ventilation and oxygenation while at~     altitude.~   "
138543|NCT01241500|"~     The primary objective of this study is to compare overall survival (OS) in patients~     receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a~     population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30%~     bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient~     population has no available therapy and a short life expectancy (approximately 4 months).~     The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies~     has the potential to delay substantially the transition of MDS to Acute Myeloid~     Leukemia(AML), a very significant and severe complication, which shortens survival of these~     MDS patients.~   "
138544|NCT01241487|"~     This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in~     hypertensive patients uncontrolled by monotherapy.~   "
138548|NCT01241435|"~     The purpose of this study is to evaluate the effect of liver function on how much of the~     study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid~     of it. Information about any side effects that may occur will also be collected.~      The duration of participation in this study is approximately 12 days not including the~     screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1~     outpatient follow-up visit. A screening visit is required within 30 days prior to the start~     of the study. This research study will be an open label study.~      The study involves a single oral dose of 18 mg LY2216684 given as 2 tablets.~   "
138549|NCT01241422|"~     The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR),~     as measured by maximal percent fall in forced expiratory volume in 1 second, in participants~     with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.~   "
138550|NCT01241409|"~     The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2~     sprinkle capsule formulations of rabeprazole sodium when administered without food to~     healthy volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium~     will be evaluated when administered with food to healthy volunteers.~   "
138551|NCT01241396|"~     The primary objective of this observational study is to document and describe current~     treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim~     of this registry is to provide accurate, descriptive information on the way Multiple Myeloma~     is treated in routine clinical practice. The registry will collect information related to~     the treatment received for Multiple Myeloma. About 3000 patients will take part in the study~     in about 28 countries. The registry will only collect information that is already in medical~     files regarding treatment. Patients will not be required to actively do anything in addition~     to what would be done without participating in this registry, nor will there be any~     procedures or interventions that are not already part of the current treatment.~   "
138552|NCT01241383|"~     Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen~     deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular~     phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of~     patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting~     enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of~     the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic~     improvement, SRC remains a severe manifestation of SSc and functional outcome and survival~     remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist~     that has recently been approved for the treatment of primary pulmonary arterial hypertension~     and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits~     on others vascular injuries and particularly in SRC.~   "
138553|NCT01241370|"~     The purpose of this study is to investigate microvascular endothelial function in the retina~     of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial~     function in the retina with several other established markers of endothelial and~     microvascular function.~   "
138554|NCT01241357|"~     The proposed research project will continue the application and development of a new method~     (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in~     the liver. The amount of iron in the liver is the best indicator of the amount of iron in~     the whole body. Measuring the amount of iron in the body is important because either too~     much (iron overload) or too little iron (iron deficiency) can be harmful. At present, the~     most reliable way to measure the amount of iron in the liver is to remove a sample of the~     liver by biopsy, either by surgery or by using a needle which pierces the skin and liver.~     Iron stored in the liver can be magnetized to a small degree when placed in a magnetic~     field. In patients with iron overload, the investigators previous studies have shown that~     magnetic measurements of liver iron in patients with iron overload are quantitatively~     equivalent to biochemical determinations on tissue obtained by biopsy. In the past the~     investigators have developed a device to measure the amount of magnetization, which was~     called a SQUID (Superconducting QUantum Interference Device) susceptometer. This device was~     validated and in use for over 20 years. The safety, ease, rapidity and comfort of magnetic~     measurements make frequent, serial studies technically feasible and practically acceptable~     to patients. The investigators have now developed a new susceptometer, which uses very~     similar technology to the SQUID, but the investigators believe is more accurate and precise.~     This study aims to validate this new instrument. The investigators will do prospective,~     serial studies of the diagnosis and management of patients with iron overload, including~     thalassemia major (Cooley's anemia), sickle cell disease, aplastic anemia, myelodysplasia,~     hereditary hemochromatosis, and other disorders. Funding Source - FDA OOPD.~   "
138555|NCT01241344|"~     The primary objective of this study is to evaluate the safety and efficacy of preemptive~     treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT~     with asymptomatic AdV viremia.~   "
138556|NCT01241331|"~     The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to~     its vehicle in the treatment of moderate-severe acne vulgaris.~   "
138557|NCT01241318|"~     This will be a cluster-randomized controlled trial to assess whether washing the umbilical~     cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when~     compared to the current standard of care, dry cord care.~   "
138558|NCT01241305|"~     The purpose of this study is to identify genes that increase the risk of developing~     vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results~     of these studies will provide vasculitis researchers with insight into the causes of these~     diseases and generate new ideas for diagnostic tests and therapies, and will be of great~     interest to the larger communities of researchers investigating vasculitis and other~     autoimmune, inflammatory, and vascular diseases.~   "
138559|NCT01241292|"~     The purpose of this study is to assess the safety and tolerability of Elotuzumab when given~     in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or~     refractory multiple myeloma (MM) in Japan.~   "
138560|NCT01241279|"~     The objective of this study is to demonstrate the correlation of near vision and changes in~     higher order aberrations following lens extraction and to characterize the defocus curves of~     Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in~     adults.~   "
138583|NCT01240980|"~     The purpose of this study is to evaluate the safety, tolerability and effect on blood~     glucose control of BMS-903452 compared to placebo in healthy subjects & relative~     bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 &~     12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also~     determine the amount of BMS-903452 in the blood.~   "
138584|NCT01240967|"~     The purpose of this study is to compare the absorption and distribution of a single oral~     dose of TC-5214 in subjects with renal impairment and with subjects with normal renal~     function.~   "
138561|NCT01241266|"~     This will be a multicenter prospective observational study carried out in China. The~     investigators will collect data in a pre-specified Case Report Form. Main data from each~     patient will include demographics, endoscopy classification, and both endoscopy and~     pharmacological treatments received by patients. Data from each patient will be~     prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by~     endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to~     30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is~     the primary outcome variable. High risk is defined as the patients with endoscopy Forrest~     classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful~     endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk~     peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in~     high risk and overall patient population will be calculated.~   "
138562|NCT01241253|"~     The study uses a randomized, placebo-controlled experimental design consisting of 4~     different test treatments matched on carbohydrate (CHO) content. The three beans are similar~     in their CHO content amount for ½ cup at ~20 grams CHO. Each of the bean varieties will be~     served in a ~½ cup serving size with ~ ½ cup of plain steamed white rice (30 grams CHO) for~     a total of 50 grams of CHO per meal for each of the three test treatments. The 4th placebo~     or control treatment consists of ~ 7/8 cup of rice alone, an amount consistent with the CHO~     content of the test meals. Most diabetic meal plans recommend no more than 45-60 grams of~     CHO per meal. Fifty grams of CHO is a standard amount for glycemic response testing in~     general.~      The investigators hypotheses were:~        -  The test meals containing the three bean types in combination with white rice will~          decrease the participants' glycemic response when eaten as part of a meal.~        -  The reduction in post-prandial glycemia will not differ between bean types in the~          elicited responses among individuals with type 2 diabetes.~   "
138563|NCT01241240|"~     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with~     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary~     open-angle glaucoma or ocular hypertension.~   "
138564|NCT01241227|"~     The aim of this prospective study was to compare the 5-year prognostic value of transient~     elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting~     survival and complications of cirrhosis in patients with chronic liver diseases.~   "
138565|NCT01241214|"~     This study will assess the efficacy and safety of different doses of ACT-129968 in adult~     patients with seasonal allergic rhinitis, due to mountain cedar pollen.~   "
138566|NCT01241201|"~     Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the~     proximal intestines. There it produces an toxin which presents a local and relevant~     challenge to the intestines. This is proposed to give an indication of general resistance~     and/or the local resistance of the intestines. The sequel of events of mucosal inflammation~     will be characterized in this study. In addition we will evaluate the effects of probiotics~     by comparing the infection symptoms and by measuring faecal weight and mucus in faeces.~      Objective: The main objective of this study is to investigate the effect of probiotics on~     the sequels of ETEC administration as intestinal permeability, inflammation and clinical~     signs as total faecal output, relative faecal dry weight and mucin excretion in faeces. In~     addition, the sequels of the mucosal inflammation will be characterized and biomarkers will~     be searched.~   "
138567|NCT01241188|"~     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and~     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.~      The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test~     is injected just under the skin and will when positive show a redness and/or swelling at the~     injection site while a negative test will leave no reactions.~      The aim of this trial is to test the C-Tb skin test in adults diagnosed with TB to determine~     if a TB infected individual has a truly positive test result (this is called to find the~     sensitivity of the skin test).~   "
138568|NCT01241175|"~     The aim of this study is to assess the effect of preoperatively administered intra venous~     magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal~     intubation in adult patients scheduled for elective non ocular surgery~   "
138569|NCT01241162|"~     This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic~     sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT)~     antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating~     chemotherapy.~   "
138570|NCT01241149|"~     Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion~     of the US population. With the advent and increased use of esophageal impedance monitoring,~     both acid and nonacid reflux disease can be better diagnosed and treated. Patients with~     severe symptoms or symptoms refractory to medical management may be offered anti-reflux~     surgery for optimal treatment. Though there are a handful of studies evaluating the efficacy~     of anti-reflux surgery on those patients with acid or non-acid related reflux disease, the~     comparison between acid and non-acid reflux disease following surgery is lacking. We propose~     a prospective study comparing clinical outcomes from those patients with acid versus~     non-acid reflux disease following anti-reflux surgery with the use of validated and disease~     specific quality of life surveys.~   "
138585|NCT01240954|"~     The purpose of this study is to compare different up-dosing schedules with Osiris.~   "
138586|NCT01240941|"~     This is a phase II Trial of MK-2206 in combination with Endocrine Therapy in patients with~     Hormone Receptor Breast Cancer. After the maximum tolerated dose is determined in the phase~     1b trial (under a separate NCT number), efficacy will be evaluated among 17 patients.~   "
138587|NCT01240928|"~     This is a phase Ib trial that evaluates the safety and tolerability of MK-2206 given in~     combination with exemestane +/- goserelin in pre- and post-menopausal patients with hormone~     receptor-positive metastatic breast cancer.~   "
138619|NCT01240486|"~     Your child is able to participate in this study, if your child's doctor is planning to start~     your child on HAART (which is a combination of at least 3 anti HIV drugs). When your child~     is treated with HAART, the way your child's body is able to fight infection may change. The~     immune system is the body's defense against infection. Your child's immune system may~     respond in a stronger way to some types of infections that your child may already have. This~     immune response may cause your child to become sick and the condition is then called immune~     reconstitution inflammatory syndrome or IRIS.~   "
138571|NCT01241136|"~     Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the~     sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who~     make up the majority of our military workforce. Surgical treatment options for pilonidal~     disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive~     procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other~     popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of~     these surgical procedures are associated with varying degrees of early and late recurrence~     rates; however, the current, more popular procedure for the treatment of pilonidal disease~     involves wide open excisions.~      A recent advancement in the minimally invasive surgical technique for pilonidal disease~     involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the~     individual pits and to drain the cyst cavities. Although this procedure has been proven to~     be effective against pilonidal disease with an overall low early recurrence rate, no~     clinical trial has been performed to rate this procedure of minimal excisions against the~     current, more common procedure of wide open excisions. A recent report has suggested that~     the recurrence rate of pilonidal disease for minimal excisions may be comparable to that of~     wide excisions. Furthermore, reports have also suggested that this minimally invasive~     procedure can be performed with minimal (and possibly local) anesthesia, less post-operative~     pain medication, and may involve a shorter convalescence time for patients.~      In order to compare the early recurrence rates of pilonidal disease and overall patient~     satisfaction between procedures involving minimal and wide open excisions, we propose to~     perform a prospective, randomized clinical trial comparing these two surgical procedures.~     Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased~     tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and~     left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized~     trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used~     for the procedure, the number of dressing changes, the length of convalescence, and overall~     patient tolerance of the procedures, both intra- and post-operatively. In addition, varying~     data points will be collected with the use of a quality of life survey and visual analog~     pain scale to analyze overall patient satisfaction. Patients will be followed for a period~     of two years following surgery to evaluate for early recurrence of their pilonidal disease.~   "
138572|NCT01241123|"~     Fast-track or enhanced recovery programs, which are the new standardized accelerated~     clinical pathways for post-operative care for colorectal surgeries, have three goals: to 1)~     quicken the return of bowel function (as evidenced by passage of flatus and stool), 2)~     decrease the length of hospital stays, and 3) decrease the rate of overall complications.~     Aside from several components, or interventions that can vary from institution to~     institution, these programs share three common modalities: early oral feeding, protocol pain~     management regimens less dependent on opioid use, and early mobilization (i.e. ambulation).~     Evidence-based practice has shown that the modalities individually contribute significantly~     to the program goals except for post-operative ambulation, which has not been shown to~     increase bowel function although it contributes to decreased pulmonary complications and~     early discharge of patients. Still, surgeons continue to advocate for early ambulation to~     aid in the return of bowel function despite the lack of clear evidence supporting this~     notion.~      The investigators propose a randomized, prospective clinical trial exploring the impact that~     post-operative ambulation has on the outcome of colorectal surgeries, particularly on the~     return of bowel function and the length of hospital stay. With the use of pedometers to~     measure physical activity, the investigators will subject patients to either the current~     traditional post-operative care or one with an aggressive ambulation regimen. Through the~     use of radiopaque markers, the investigators hope to correlate increased ambulation with~     increased gastrointestinal motility function to prove the impact of early ambulation on~     post-operative care.~   "
138573|NCT01241110|"~     Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin~     +Metronidazole in outpatients with Pelvic Inflammatory Disease.~      Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated~     by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine~     1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy~   "
138574|NCT01241097|"~     -  To test the hypothesis that therapy with high dose statin provides endothelial superior~          benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.~        -  To test the hypothesis that therapy with high dose statin provides anti-inflammatory~          effect than the same reduction of cholesterol with low dose of statin plus ezetimibe~   "
138575|NCT01241084|"~     Objective The aim of the trial is to evaluate the beneficial effects of the oral~     administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation~     in children with mild to moderate persistent asthma.~      Study design This is a randomized, double-blind, placebo controller trial. 50 children will~     be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on~     the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus~     ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be~     under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any~     inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.~      Patients will be randomly divided into 2 treatment groups:~      Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops~     daily).~      Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0),~     after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the~     supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO~     determination and exhale condensate analysis.~      During the entire trial period the number of asthmatic exacerbations and the use of beta-2~     antagonists will be monitored by a diary properly examined at T1, T2 and T3.~      All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit~     Michele Miraglia del Giudice of the F. Fede Pediatric Department.~      The analysis of the inflammatory markers on the exhaled condensate will be performer at T1,~     T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.~      During the trial it will be possible to administer only salbutamole MDI if it needed. If~     patients will be administered with any systemic corticosteroids they will exit from the~     trial.~      At the enrolment period all patients will receive the completed information on the trial and~     the informed consent will be properly signed.~   "
138576|NCT01241071|"~     The purpose of this study is to determine whether myofascial release techniques are~     effective in the improvement of pain, disability and electromyography response of lumbar~     muscles in patients with chronic low back pain.~   "
138577|NCT01241058|"~     A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was~     created in Belgium. Over a 2 year period 257 patients are included. These patients will be~     follow up prospectively during 5 years. Demographic data, family history, disease~     presentation and disease course including medication are registered in CRF's.~   "
138578|NCT01241045|"~     To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its~     efficacy in facilitating induction of midtrimester abortion.~   "
138579|NCT01241032|"~     This study is designed to to investigate the effects of alcohol on the pharmacokinetics of~     Udenafil tablet in healthy male volunteers~   "
138580|NCT01241019|"~     The purpose of this study is to determine whether the administration of topiramate to~     newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of~     treatment with hypothermia.~   "
138581|NCT01241006|"~     This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus~     5 days of oral prednisone in the treatment of mild to moderate asthma exacerbations to~     prevent relapse with an unscheduled return visit to a health care provider for additional~     asthma treatment within 14 days. The investigators hypothesize that the two treatments will~     be equally effective in relapse prevention.~   "
138588|NCT01240915|"~     MultiStem(r) is a new biological product, manufactured from human stem cells obtained from~     adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells~     are believed to reduce inflammation and regulate immune system function, protect damaged or~     injured cells and tissue, promote formation of new blood vessels, and augment tissue repair~     and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of~     Graft versus Host Disease with almost complete reversal of gastrointestinal pathology~     (similar to pathology that would be expected in Ulcerative Colitis). These data, together~     with safety data generated in 2 other clinical trials, suggest that MultiStem has the~     potential to be a new treatment option for patients with ulcerative colitis. This is the~     first study of MultiStem in this patient population and will cautiously explore the~     safety/toleration and potential benefit of this new treatment in patients with moderate to~     severe disease.~   "
138589|NCT01240902|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®~     System in the treatment of symptomatic severe aortic stenosis in subjects who have a~     predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.~   "
138590|NCT01240889|"~     This study will be a randomized, double blind, placebo-controlled, parallel group study and~     will include subjects with ragweed-induced seasonal allergic rhinitis.~   "
138591|NCT01240876|"~     The primary objective of the study is to evaluate the safety and efficacy of CEP-37247~     compared with placebo as assessed by the occurrence of adverse events, and the mean change~     in average pain intensity (API) in the affected leg.~   "
138592|NCT01240863|"~     The primary objective of this study is to evaluate efficacy of hydrocodone extended-release~     tablets compared with placebo in alleviating moderate to severe pain in patients with~     osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at~     week 12.~   "
138593|NCT01240850|"~     Chronic periaortitis is a clinico-pathological entity encompassing idiopathic~     retroperitoneal fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this~     disease is generally based on the use of glucocorticoids, which are often effective.~     However, prolonged steroid treatments are usually needed to achieve a sustained remission;~     additionally, patients frequently develop disease relapses following treatment~     discontinuation, therefore they may be exposed to high cumulative doses of glucocorticoids.~      Preliminary data reported in the literature show that methotrexate may be effective in~     combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often~     used as a steroid-sparing agent in different inflammatory diseases.~      The aim of this study is to evaluate whether a treatment with low-dose prednisone plus~     methotrexate is non-inferior to conventional dose-prednisone in achieving remission in~     retroperitoneal fibrosis patients.~   "
138594|NCT01240837|"~     The purpose of this study is to determine by how much, the ingestion of palm sugar increases~     blood glucose concentrations and what the corresponding glycaemic index is. The~     investigators estimate that the glycaemic index will be 68 (equal to that of sucrose).~   "
138595|NCT01240824|"~     The purpose of this study is to evaluate whether a new potential treatment for non invasive~     bladder cancer is safe and if it leads to side effects such as irregular heart rate,~     agitation, or burning with urination. Patients who have early stage bladder cancer and will~     be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to~     participate in a study where they are given the standard BCG followed by the experimental~     drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer~     patients, at the current time we do not know if it has any benefits at all. We have data in~     mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.~   "
138596|NCT01240811|"~     This pilot study is being performed to investigate the influence that starting contraception~     with an IUD has on the local immune cell populations and features, with a particular focus~     on the cells and cell-surface features that are important in HIV transmission (CD4 cells and~     CCR5 cell receptors).~      Based on results from large epidemiologic studies there seems to be a consistent finding of~     slightly increased HIV acquisition in women who use hormonal contraception. It is not clear~     if this is due to a biological phenomenon or if it relates to a difference in sexual~     behaviors/risks of women on hormonal contraceptives.~      The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within~     the upper and lower genital tract of women 2 months after placement of progestin-containing~     intrauterine devices for contraception as compared with women not using hormonal~     contraception.~   "
138597|NCT01240798|"~     People report feeling sad and low (depression) or worried (anxiety) appear more likely to~     subsequently suffer a heart attack, or angina. However it is not known whether depression or~     anxiety actually causes heart disease. If these mental health problems and heart disease~     were cause and effect this has important implications for world health. Previous research on~     this topic has had several limitations. First, most studies have studied heart disease as if~     it were one thing. There is a need for studies which distinguish different types of heart~     disease (e.g. different types of heart attack, angina) which may be linked to mental health~     problems in different ways. Second, it is not clear whether symptoms of heart disease come~     before the depression or anxiety or the other way round? Much of the available research~     cannot look at this in detail because they rely on data from occasional snapshots of study~     populations rather than a continuous record. The investigators propose to use the linkage of~     the national registry of coronary events to general practice records in the GPRD, which will~     allow us to address these limitations. The investigators research will help us understand~     better whether mental health problems cause the onset of different types of coronary~     disease.~   "
138598|NCT01240785|"~     Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used~     worldwide in the treatment of type 2 diabetes and also in a few studies on patients with~     gestational diabetes. The investigators aim is to compare insulin and metformin in the~     treatment of gestational diabetes. The investigators hypothesis is that there is no~     difference between insulin and metformin treated mothers in the main outcome criteria (birth~     weight, neonatal complications).~   "
138658|NCT01239979|"~     The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among~     patients with stable and unstable CAD patients and control subjects, and correlate with~     inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2,~     Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.~   "
138599|NCT01240772|"~     This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease:~     doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy~     according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk~     and is more cost-effective than SH. With a large number of patients managed in more than 20~     centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating~     haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM~     would demonstrate to be cost-effective for health care system and attractive for patients.~   "
138600|NCT01240759|"~     The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered~     with metformin in subjects with type 2 diabetes mellitus.~   "
138601|NCT01240746|"~     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the~     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),~     and the investigational TIV containing the alternate B (B2) strain in children.~      Primary Objective:~      To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011~     TIV (containing the primary B strain) and investigational TIV (containing the alternate B~     strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains~     separately among children aged 6 months to less than 9 years of age~      Secondary Objective:~      To demonstrate superiority of antibody responses to each B strain in QIV compared with~     antibody titers following vaccination with the TIV that does not contain the corresponding B~     strain, as assessed by GMT ratios and seroconversion rates.~      Observational Objective:~      To describe the safety profile of QIV among subjects 6 months to less than 9 years of age,~     as assessed by solicited injection site and systemic adverse events (AEs) collected for 7~     days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination,~     and adverse events of special interest and serious adverse events (SAEs) collected from~     Visit 1 to Visit 2.~   "
138602|NCT01240720|"~     The aim of this Study Protocol is to provide a basis for the clinical development of~     131I-F16SIP as an anti-cancer therapeutic agent.~      The study follows and is greatly motivated by the promising results of a Phase I/II study~     with a similar investigational drug developed by our Company, 131I-L19SIP, in several~     Italian centers.~   "
138603|NCT01240707|"~     Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and~     impaired gas exchange. In this study the investigators will examine if the scope of~     inhalation injury can be assessed soon after hospital admission based on clinical markers,~     biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a~     lung function test and metacholine test will be performed to examine whether patients have~     developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke~     exposure.~   "
138604|NCT01240694|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72~     weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated~     in a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8~     (week 24 of that study).~   "
138605|NCT01240681|"~     The objective of this pilot study is to determine the effectiveness of Fluorothymidine~     Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance~     Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women~     with locally advanced breast cancer.~   "
138606|NCT01240668|"~     The registry is a multi-center, prospective, observational study designed to collect data in~     patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and~     hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)~     in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The~     registry is observational in design, and the registry will collect data on patients with a~     serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the~     duration of the hospital, from admission to discharge, and the data will be entered into the~     case report form (CRF) or into an electronic data capture (EDC) system. These patients will~     be entered into the registry over the duration of 18 months at community, tertiary, and~     academic medical centers from diverse multiple regions of the USA and Europe.~      A patient's treatment will be determined by their caregiver and not by this protocol. Thus,~     the registry will provide a unique opportunity to evaluate how the patients are managed~     under real-world management conditions.~   "
138607|NCT01240655|"~     This is a dose escalation study that will assess the safety and efficacy of LCL161 in~     combination with weekly paclitaxel in adult patients with advanced solid tumors.~   "
138608|NCT01240642|"~     The purpose of this study is to determine the effect of the ASA404 infusion rate and~     co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on~     the pharamcokinetics (PK) of free and total ASA404.~   "
138609|NCT01240629|"~     This is a research study for advanced prostate cancer. An experimental drug called AN-152~     (also known as AEZS-108) will be used. The purpose of this study is to test the safety,~     tolerability and benefits of an experimental drug called AN-152.~      The participants tumor will be tested for expression of this receptor (using an old biopsy).~     If the participants cancer does not have this receptor, participants will not be eligible to~     participant in this study.~      AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the~     specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.~      Participants will continue treatment until death, disease progression, unacceptable~     toxicity, participants refusal, treatment delay >3 weeks, or the completion of 6 cycles.~     Continuation beyond 6 cycles is left at the discretion of the study doctor.~      The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37~     for the Phase II portion).~   "
138617|NCT01240512|"~     This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day)~     versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early~     stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants~     per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will~     be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring,~     clinical laboratory safety tests and adverse event assessments will be performed to evaluate~     the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be~     stored for future biomarker assessments. The total duration of the study is anticipated to~     be 18 months, assuming a 12 month enrollment period.~   "
138610|NCT01240616|"~     Background:~      - A brain circuit called the default network is the brain circuit that is active when the~     brain is at rest; that is, when individuals are not concentrating on specific tasks.~     Previous research has shown that the default network functions differently in people with~     schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and~     concentration that can affect people who have these conditions. Studies have also shown that~     nicotine affects the default network, but more research is needed on the ways in which~     nicotinic receptors may change activity in these regions and thereby affect individuals~     ability to concentrate on specific tasks.~      Objectives:~      - To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic~     receptors, affect the default network in nonsmokers in ways that improve thinking and~     concentration.~      Eligibility:~        -  Healthy, right-handed volunteers between 21 and 50 years of age.~        -  Volunteers must not have used any kind of tobacco product in the past 2 years.~      Design:~        -  This study involves an initial screening visit, a training visit, and three testing~          visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood and urine samples and questions about smoking history.~        -  Participants will have an initial training session to practice the tasks that will be~          done during magnetic resonance imaging scans at the testing visits. These tasks will~          test participants concentration and memory.~        -  Participants will have three test sessions with the following combinations of study~          drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of~          mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given~          at each visit, and participants will not know which one they receive.~        -  Participants will perform the same concentration and memory tasks at each testing~          visit, and will provide a blood sample after each visit to determine levels of nicotine~          and mecamylamine.~   "
138611|NCT01240603|"~     Plasmodium falciparum parasite clearance rates (PCRs) after oral artesunate treatment of~     patients with uncomplicated malaria were recently found to be significantly slower in Pailin~     (Western Cambodia) compared to Wang Pha (Eastern Thailand). This difference in PCRs has been~     attributed to different histories of artesunate drug pressure in the two areas. In Pailin,~     artesunate monotherapy has been used inappropriately for 30 years and is hypothesized to~     have selected for artemisinin-resistant parasites (slow PCRs). To investigate the potential~     contribution of human factors to the artemisinin resistance phenotype, we have identified a~     study site in Eastern Cambodia where artemisinin-resistant parasites are not believed to be~     present. The main aims of this study are to 1) determine whether the artemisinin resistance~     phenotype (i.e., a half-life longer than the 2-hour half-life observed in Wang Pha) is~     present in Eastern Cambodia, 2) determine whether hemoglobin E affects parasite clearance~     rates in vivo, 3) determine whether age-associated acquired immunity affects parasite~     clearance rates in vivo, and 4) identify parasite-heritable traits that are associated with~     slow parasite clearance rates in vivo. To meet these aims, we are conducting a prospective,~     longitudinal study to recruit Cambodian residents of Lumphat District in Ratanakiri Province~     who complain of fever and/or symptoms of malaria. Patients diagnosed with uncomplicated~     malaria will be treated with weight-based doses of artesunate given orally each day for 3~     days followed by mefloquine given orally for 2 days. During this time, finger prick blood~     smears will be obtained every 6 hours until parasite density is zero. From these data, we~     will estimate parasite clearance rates using a half-life parameter. We will also collect~     parasitized red blood cell samples from malaria patients prior to antimalarial drug~     administration. These parasites will be tested in short-term in vitro culture experiments to~     determine their susceptibility to artemisinins and other antimalarial drugs....~   "
138612|NCT01240590|"~     Background:~      Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors;~     chemotherapy and surgery have had no impact on local control or survival of patients, with a~     median survival of 3-7 months.~      Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have direct~     antitumor effects in vivo and in vitro, destabilizing spindles and inducing apoptosis,~     resulting in the disruption of neovascular endothelial cells with disruption of blood flow~     to the tumor. Early clinical studies with combretastatin, from which crolibulin is derived,~     demonstrated efficacy in a subset of patients with ATC.~      Objectives:~      The primary objective in the Phase I portion is to assess the safety and tolerability of~     cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.~      We will assess the toxicities of crolibulin coadministered with cisplatin, evaluate~     dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the~     combination.~      The primary objective in the Phase II portion is to compare the combination crolibulin plus~     cisplatin versus cisplatin alone in adults with ATC by assessing the duration of~     progression-free survival (PFS); comparison of the response rates as evaluated by Response~     Evaluation Criteria in Solid Tumors (RECIST) will be an important secondary objective.~      We plan on biochemical and immunohistochemical analysis of several tumor parameters~     including mitotic index, expression of several proteins including epidermal growth factor~     receptor (EGFR), vascular endothelial growth factor receptor (VEGFR), BRAF, excision repair~     cross-complementation group 1 (ERCC1) and tumor protein p53 (TP53). Where sufficient tissue~     is available we will also perform gene expression analysis, micro ribonucleic acid~     (microRNA) array analysis, and compare these with 3-deoxy-3 -[(18)F] fluorothymidine~     (FLT)-positron emission tomography (PET) and tumor growth rate constant.~      Eligibility:~      Phase I: adults age 18 and older with unresectable, recurrent or metastatic solid tumors.~      Phase II: adults age 18 and older with anaplastic thyroid cancer.~      In the phase II portion disease must be evaluable by RECIST.~      All patients must have adequate hepatic, renal, and bone marrow function.~      Design:~      The Phase I component consists of dose-escalation cohorts of three to six patients, in which~     all patients receive both the study drug crolibulin with cisplatin. The MTD and DLT will be~     determined based on toxicities during the first three weeks of combined therapy.~      The Phase II component will be a randomization study, to either crolibulin with cisplatin or~     cisplatin monotherapy. Patients randomized to cisplatin alone will have the opportunity the~     opportunity to cross over to the crolibulin arm in the event of tumor progression.~      Drug administration will take place on days 1, 2, and 3 for crolibulin, and on day 1 for~     cisplatin, on a 21-day cycle.~      Maximum number of patients for planned enrollment is 70. During the Phase I portion of the~     study, dose-seeking cohorts of three to six patients will be enrolled until MTD / DLT is~     reached for a maximum of three dose cohorts [up to 24 patients if one assumes an expansion~     cohort to twelve patients at the recommended phase 2 (RP2) dose]. During the randomized~     Phase II trial comparing the activity of the combination of crolibulin plus cisplatin with~     cisplatin alone it is estimated that a maximum of 40 patients will be enrolled [1:1~     randomization 20 + 20 = 40 patients], and we will allow for 6 extra patients to be enrolled~     to compensate for a small number of non-evaluable patients.~   "
138613|NCT01240577|"~     Background:~      - The experimental drug IPdR is broken down in the body to IdUrd, which has been given to~     patients to find out if it can improve radiation therapy. IdUrd has to be given through a~     vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers~     are interested in determining whether IPdR should also be studied to find out if it can~     improve radiation therapy. The current study is to find out if people absorb the drug given~     by mouth.~      Objectives:~      - To evaluate the levels of drug and its breakdown products in the blood following a single~     dose of IPdR by mouth. .~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or~     lymphomas) that have not responded to standard treatment.~      Design:~        -  This study involves an initial dosing visit, one day of admission to the hospital for~          blood work, and a follow-up visit 14 days later.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood and urine samples.~        -  Participants will receive a single dose of IPdR, and will provide multiple blood and~          urine samples for 24 hours after administration of the drug.~        -  Fourteen days after receiving IPdR, participants will have another physical examination~          and additional blood and urine tests to evaluate how IPdR has been broken down by the~          body.~        -  Cancer treatment will not be provided as part of this protocol.~   "
138614|NCT01240551|"~     Background:~      - Sodium fluoride (NaF) is a common compound that is found in various foods and can be used~     to increase bone strength. When this compound is added to a small dose of radiation (F-18),~     it collects in the bones, with higher amounts in areas where the bone is rapidly changing,~     such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined~     positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able~     to better measure the changes in the bone that may indicate that a certain type of cancer~     (such as prostate cancer) has spread to the bones.~      Objectives:~        -  To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and~          their change over time and compare with clinical course, in individuals with prostate~          cancer.~        -  To determine the smallest amount of change in the bone tumors that F-18 NaF can~          accurately measure.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and have had~     imaging studies to determine whether the cancer has spread to their bones. Both patients~     with and without known bone involvement will be enrolled.~      Design:~        -  Participants will be screened with a physical examination, medical history, and imaging~          studies, and will provide baseline blood samples to evaluate kidney function.~        -  For the study, participants will have two F-18 NaF PET/CT scans on separate days for~          baseline. These repeat scans will be used to determine the amount of change that is due~          to the imaging process alone (i.e. not due to the disease getting better or worse.~          Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT~          scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a~          complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection.~          Participants will be watched closely for side effects from the F-18 NaF until the scans~          are done, and will be asked to drink plenty of water to void the F-18 NaF from the body~          after the scans.~        -  As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8~          months after the first scans and then one 10 to 14 months after the first scans.~          Participants will provide additional blood samples before the followup scans.~   "
138615|NCT01240538|"~     This phase I trial studies the side effects and the best dose of viral therapy in treating~     young patients with solid tumors that have come back or that have not responded to standard~     therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off~     a virus called wild-type reovirus. The virus causes cells with this weakness to die, and may~     therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a~     drug used in chemotherapy that stops tumor cells from dividing and causes them to die.~     Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells.~   "
138616|NCT01240525|"~     RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a~     donor stem cell transplant helps stop the growth of cancer cells. It also stops the~     patient's immune system from rejecting the donor's stem cells. The donated stem cells may~     replace the patient's immune cells and help destroy any remaining cancer cells~     (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte~     infusion) that have been treated in the laboratory after the transplant may help increase~     this effect. Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving alemtuzumab before transplant and cyclosporine after~     transplant, may stop this from happening.~      PURPOSE: This randomized phase II trial is studying donor lymphocyte infusion after stem~     cell transplant in preventing cancer relapse or cancer progression in patients with~     follicular lymphoma, small lymphocytic non-Hodgkin lymphoma, or chronic lymphocytic~     leukemia.~   "
138620|NCT01240473|"~     Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh~     with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved~     in a project for improving the surveillance of KA in Trishal, Mymensingh since 2005.~     Improvement of case detection is necessary for both surveillance purposes and better~     control. The aims of this pilot study are to assess some newer techniques for diagnosis of~     KA using blood and urine samples of suspected cases; and evaluate response to treatment with~     sodium stibogluconate to which resistance has been reported in India, considered to be a~     part of the same zone harboring the disease agent Leishmania donovani and transmitted by the~     same vector Phlebotomas argentipes (sand-fly). No data is currently available on response to~     sodium stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been~     evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in~     Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh~     to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine.~     They interacted with scientists of ICDDR,B and expressed their interest to help develop~     ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned,~     multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites~     for the trial. The aims of the proposed study are to train physicians and laboratory~     personnel in preparation for the future drug trial(s) on KA as well as to compare different~     tests for its diagnosis that might improve case detection at the field level and used for~     research purposes. The investigators will also examine in greater detail the different~     Leishmania species circulating in the area of Mymensingh and whether treatment failure and~     occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.~   "
138621|NCT01240460|"~     The purpose of this study is to measure what effect the study drug XL765 (SAR245409) or the~     study drug XL147 (SAR245408) has on tumor tissue in subjects with recurrent glioblastoma~     (GB) who are candidates for surgical resection. XL765 (SAR245409) and XL147 (SAR245408), the~     two investigational agents examined in this study, XL147 (SAR245408) is a potent inhibitor~     of PI3 Kinase (PI3K) and XL765 (SAR245409) is a dual PI3K and mTOR inhibitor. In preclinical~     studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis~     (programmed cell death) in tumor cells.~   "
138622|NCT01240447|"~     This study is designed to evaluate safety and immunogenicity of racotumomab in patients with~     advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel)~     when a second-line therapy is indicated. The study will also compare survival and~     progression free survival on both study arms.~   "
138623|NCT01240434|"~     The investigators perform a simple-blind randomized trial with two groups, one in which all~     the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and~     another in which the orifices are left open, closing only the skin (Group B). Monitoring for~     trocar site hernia lasted 2 years from the intervention.~   "
138624|NCT01240421|"~     This expanded access program is an open-label, multi-center study, which will consist of a~     PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic~     breast cancer who fulfill the eligibility criteria will be treated. The program will~     continue in each country until eribulin is approved, reimbursed and launched in that~     country, or termination of the program by the Sponsor.~   "
138625|NCT01240408|"~     This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy~     subjects. The study will consist of two phases: Pre-randomization and Randomization. The~     Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization~     Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted~     and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg~     lenvatinib either with or without a standard breakfast. There will be a 2-week washout~     between treatments.~   "
138626|NCT01240395|"~     The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy~     (MBCT) on physical symptoms attributed to chemical exposures, psychological distress,~     illness worry, quality of life, and illness perceptions in patients suffering from multiple~     chemical sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a~     possible symptom reduction is mediated by an increased level of mindfulness.~      The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to~     which chemical exposures causes symptoms and the impact on daily life will be significantly~     improved in the MBCT treatment group as compared to the control group.~   "
138627|NCT01240382|"~     To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6~     times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate~     ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical~     administration), is at least non-inferior in the change in fluorescein staining score, and~     is superior in the change in Rose bengal score, in a multicenter, double-masked,~     parallel-group comparison study. Safety profile will likewise be compared.~   "
138628|NCT01240369|"~     Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The~     main problem is lack of effective tool in early detection that accounts for the poor outcome~     of cancer. Clinically, over 80% of patients with cancer were at late stage when they were~     diagnosed. Therefore, it is important for us to find the biomarker that serve as the early~     prediction of cancer.~      The investigators have published that VEGFC over-expressed in non-small cell lung cancer.~     VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of~     lymphatic endothelial cells and enhances migration and invasion. Investigator found that~     VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile~     to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer.~      MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21~23~     nucleotides that function as post-transcriptional gene regulators. Recent studies indicated~     that certain microRNAs reduced in cancer patients. Therefore it is important to investigate~     whether specific microRNA changed in certain kinds of cancer patients.~   "
138629|NCT01240356|"~     The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free~     transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke~     patients. If found to be safe, the widespread use of operator-independent,~     ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy~     trial.~   "
138630|NCT01240343|"~     The purpose of this study is to develop a BioBank (a specialized lab) and collect blood,~     fluids and/or other tissue samples to study eye diseases.~   "
138631|NCT01240330|"~     The objective of this clinical study was to demonstrate the performance of the Vasculaire~     Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This~     study was a single-arm, open label, prospective, single-center clinical study.~   "
138684|NCT01239641|"~     The purpose of this study is to determine whether HIFU has superiority over traditional~     surgery on satisfaction and adverse impact.~   "
138632|NCT01240317|"~     In this study, the investigators are testing the expert system called eVENT. eVENT provides~     expert advice about the patient's breathing. The investigators have developed and tested a~     prototype of eVENT and now want to test how it works in practice. To do this the~     investigators plan to use computer based simulations and test it when used by~     anesthesiologists in a full size human simulator. If these tests are successful the~     investigators will then be ready to evaluate eVENT on real patients.~   "
138633|NCT01240304|"~     The purpose of this phase II clinical trial study is to assess the resection rate among~     subjects who have been initially diagnosed with unresectable or borderline resectable~     pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will~     include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this~     clinical trial will assess the safety of preoperative chemotherapy with radiation therapy~     for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic~     head, assess margin-negative resection rates, disease-free survival, assess overall survival~     rates, and determine patterns of local and distant recurrence.~   "
138634|NCT01240291|"~     The purpose of this trial is to investigate if pharmacologically safe dose intravenous~     glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition~     is associated with improved clinical outcomes in terms of decreased organ dysfunction,~     infectious complications, and other secondary outcomes~   "
138635|NCT01240278|"~     Increased mammographic density is recognized as an important risk factor for developing~     breast cancer, however, the underlying mechanism explaining this relationship is unclear.~     The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately~     distinguish dense tissue on mammography which is at high risk from dense tissue at low risk~     by indicating cellular activity in dense tissue as radiotracer uptake (functional density)~     in the breast. In this pilot study, the investigators want to compare the histological~     characteristics of breast tissue in patients with who have similar density on mammography~     but different levels of functional density on MBI.~   "
138636|NCT01240265|"~     Adequate vitamin D is essential for proper infant growth and development. However, human~     milk is low in vitamin D, and most infants do not receive recommended supplementation. Our~     aim is to assess the feasibility of providing adequate vitamin D to breastfed infants~     through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18~     years of age with exclusively breastfed infants between the ages of 1 and 6 months will be~     randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a~     single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary~     calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28~     of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.~   "
138637|NCT01240252|"~     The study is being conducted to find out why too much fat in your blood stream may cause~     insulin resistance in your muscles. Insulin is the hormone, produced normally by your body,~     which causes your blood sugar to return to normal after you eat.~   "
138638|NCT01240239|"~     The purpose of the study is to evaluate different methods of pre-anesthesia consultation,~     with the aim of improving the day of surgery experience for the patient. In this study, we~     will use a telephone consultation, an in-person consultation, and a telemedicine~     consultation, which involves television cameras and monitors that allow live two-way~     communication for the pre-anesthesia consultation. The reason for this study is to evaluate~     the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists~     have been highly satisfied in previous studies using pre-anesthesia telemedicine~     consultation. In this study, we will examine a larger group of patients, as previous studies~     have studied smaller groups of patients.~   "
138639|NCT01240226|"~     This will be a single-center, open-label, randomized, 2-part study to determine the relative~     bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of~     ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.~   "
138640|NCT01240213|"~     Experimental and human data suggests that vitamin D could protect against breast cancer.~     Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may~     reduce production of fat tissue, thereby reducing weight gain, which would result in lower~     levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this~     study is to test the effect of vitamin D supplementation on the response to a weight loss~     (diet + exercise) intervention and select breast cancer risk factors in overweight and obese~     postmenopausal women with low blood vitamin D levels.~   "
138641|NCT01240200|"~     Several studies have shown that high blood sugar (glucose) levels are associated with~     diseases caused by the diabetes. Controlling the glucose may prevent these complications. As~     people age, their bodies become unable to make enough insulin to control the blood sugars.~     Pills used to treat diabetes may help for a while, but many times this does not last. When~     the blood sugar is too high, insulin is frequently recommended and used to treat diabetes.~     Insulin is often started by adding a long-acting insulin to the medicines a patient already~     takes. In this study, glargine insulin will be taken together with the diabetes pills~     currently being used. Glargine is a long-acting insulin which is given under the skin once a~     day. Glargine is approved for use in the treatment of patients with diabetes by the FDA~     (Food and Drug Administration).~      Currently, insulin delivery is only available as a shot. The purpose of this study is to~     compare how satisfied patients are when using two different types of insulin shots.~     Specifically, this study aims to determine if people over 65 years old are more satisfied~     taking insulin shots by pens or syringes. Everyone who joins in this study will have a~     chance to use the insulin syringes and the insulin pens.~      The ability of patients to give themselves shots can affect how well the sugar is~     controlled. As people age, medical and other problems may develop that affect their ability~     to do certain things. Another aim of this study is to determine if the ability to use an~     insulin pen and insulin syringe is affected by age or some other problem.~      During this 25 week long study, patients will be treated with insulin given by a syringe for~     12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction~     with treatment throughout the study. The investigators hypothesize that among elderly~     patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal~     insulin via a pen device results in higher treatment satisfaction scores and more accurate~     dosing than treatment with basal insulin via conventional vial/syringe methods.~      A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for~     the study is Grady Memorial Hospital clinics.~   "
138642|NCT01240187|"~     The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and~     one 12 mg tablet of perampanel in healthy subjects.~   "
138685|NCT01239628|"~     The purpose of the protocol is to evaluate injection intervals and treatment modalities up~     to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper~     limb spasticity after stroke.~   "
138686|NCT01239615|"~     Aim: To study the stability of brain MR-scanning parameters (blood-flow, microstructure,~     volume, metabolism) over 1 week in health volunteers.~      Hypothesis: MR-scanning parameters are stable over 1 week in healthy volunteers~   "
138643|NCT01240174|"~     Studies show, guidelines state, and performance measures assert that antibiotic prescribing~     for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe~     antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States~     each year. Previous successful interventions have only reduced the antimicrobial prescribing~     rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis~     can be brought to near zero percent in actual practice while maintaining patient safety and~     satisfaction. The goal of this study is to develop an Electronic Health Record~     (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis~     with a goal of reducing the antibiotic prescribing rate to near zero percent.~   "
138644|NCT01240161|"~     The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue)~     biomarkers will better predict early brain tumor response to treatments and will be more~     reliable prognostic markers in patients with malignant brain tumors.~   "
138645|NCT01240148|"~     The purpose of this study is to investigate the effect of AZD3161 on mechanical pain~     sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.~   "
138646|NCT01240135|"~     The purpose of this study is to evaluate the clinical performance of a silicone hydrogel~     contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).~   "
138647|NCT01240122|"~     An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS~     at specific time points over the course of four days. The study was conducted with~     PureVision lenses.~   "
138648|NCT01240109|"~     The objective of this study was to compare the effect of remifentanil on suppression cough~     reflex during emergence in patient anesthetized using either propofol or sevoflurane~     additionally under infusion of the identical concentration of remifentanil.~   "
138649|NCT01240096|"~     Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo,~     followed by 8 weeks of open-label mirtazapine 15 mg daily~   "
138650|NCT01240083|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of~     the frontal cortex are used to modulate the neuronal excitability in patients with~     depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst~     Stimulation of the DLPFC is more effective in patients with a depressive episode.~   "
138651|NCT01240070|"~     Despite several clinical trials have clearly demonstrated that the correction of a single~     cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of~     myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study~     has been evaluating the effect of a multifactorial intervention strategy on macrovascular~     complications of diabetes. For this reason, the disease management approach currently~     endorsed by international guidelines (i.e correction of all major CVD risk factors to target~     levels usually lower than lower risk populations) has not been extensively investigated in~     terms of prevalence of application in current clinical practice and in terms of real~     efficacy.~      The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric~     two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of:~     (1) investigating the degree of application of the international guidelines for CVD~     prevention in type 2 diabetic patients and (2) verifying whether the application of an~     intensive multi-factorial intervention inspired by these guidelines is feasible and~     effective in decreasing the incidence of new CVD events.~   "
138652|NCT01240057|"~     This trial investigates whether prenatal intervention improves survival rate of fetuses with~     isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to~     expectant management during pregnancy, both followed by standardized postnatal care.~   "
138653|NCT01240044|"~     This study intend to assess the pain intensity of newborns in neonatal intensive care unit~     (NICU) undergoing different techniques of respiratory therapy and compare these procedures.~     A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The~     babies were categorized according to gestational age , age, weight, diagnosis, support and~     signs of respiratory distress. Then, they were allocated by lot to come from one of 3~     groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal~     rebalancing. Each newborn received just one physical therapy session in that they were~     assessed before one of the three procedures (T1), immediately after (T2) and after 15~     minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart~     and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP).~     The hypothesis is that newborns hospitalized in intensive care unit did not show pain when~     undergoing respiratory therapy.~   "
138654|NCT01240031|"~     The purpose of this study is to determine whether individualised nutritional therapy~     comprised of appetising, energy- and protein-rich foods can have a positive effect on~     physiological function and quality of life of undernourished patients as compared to usual~     nutrition care.~   "
138655|NCT01240018|"~     The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb.~     Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone~     response in a single meal test and to determine whether the acute effects persist after~     daily supplementation of the probiotic capsule.~   "
138656|NCT01240005|"~     30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the~     time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several~     studies have been initiated to find alternative therapeutic options.~      Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with~     a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced~     peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor~     cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be~     enhanced by incubation with dendritic cells (DC), which are the most potent antigen~     (Ag)-presenting cells.~      The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell~     treatment following regular therapy and the effects of this therapy on immune responses in~     patients with renal cell carcinoma after surgery.~   "
138657|NCT01239992|"~     The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial~     lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and~     postprandial biomarkers of endothelial dysfunction and inflammation.~   "
138659|NCT01239966|"~     In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical~     ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold~     standard for supportive care. However, despite a relative low tidal volume, approximatively~     one third of patients will experienced tidal hyperinflation, a phenomenon known to induce~     pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4~     ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia~     and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra~     corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.~      Patients with ARDS also frequently develop acute renal failure which may required Renal~     Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.~      The investigators hypothesized that a strategy combining ECCOR and RRT early in the course~     of patients presenting ARDS and acute renal failure will allow the tidal volume to be~     further reduced, providing lung protection, while avoiding the arterial CO2 tension to be~     increased.~      For this purpose, the investigators sought to evaluate the safety and efficacy of adding a~     membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the~     hemofilter.~   "
138660|NCT01239953|"~     Treatment of patients with bare metal stent restenosis remains a challenge. This study will~     assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting~     stent) is superior in the treatment of patients suffering from bare metal stent restenosis.~   "
138661|NCT01239940|"~     Treatment of patients with drug-eluting stent restenosis remains a challenge. This study~     will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting~     stent) is superior in the treatment of patients suffering from drug-eluting stent~     restenosis.~   "
138662|NCT01239927|"~     This prospective randomized trial is to prove the equivalence of primary sigmoid resection~     with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate~     anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients~     with peritonitis caused by perforated left-sided colon diverticulitis.~   "
138663|NCT01239914|"~     COACT registry is a multicenter registry of consecutive patients undergoing coronary stent~     implantation at 8 centers in the Catholic University of Korea to evaluate the real world~     management of patients with coronary artery disease and to assess their in-hospital, medium~     and long-term outcomes.~   "
138664|NCT01239901|"~     The purpose of this research study is to determine the frequency and severity of iron~     overload in patients with Sickle Cell Anemia and its relationship to blood vessel function.~     The investigators hypothesize that intermittent transfusions that these patients receive~     during hospitalizations produces significant iron overload and impairs blood vessel~     relaxation.~   "
138665|NCT01239888|"~     The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and~     tibolone ad-on can induce a response to antidepressants in patients with treatment resistant~     depression.~   "
138666|NCT01239875|"~     RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells~     and white blood cells may help the body build an effective immune response to kill tumor~     cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with~     cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine~     therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's~     lymphoma.~   "
138667|NCT01239862|"~     The aim of this study was to analyze the safety, pulmonary function, and quality of life~     data of patients with silicosis treated with intrabronchial instillation of bone marrow~     derived mononuclear cells (BMDMC, 2x107) through bronchoscopy.~   "
138668|NCT01239849|"~     Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of~     related evidences have been published including CARDS study that showed definite benefit of~     statin treatment in DM patients and influenced ADA guideline. & NCEP ATP III update.~     However, there are large unmet medical needs for DM patients who don't reach their target~     LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest~     dose of statin and then titrate to the goal. Thus, we are curious about changing our~     prescription pattern into more tailored way; selecting starting dose based on the individual~     risk factors and concomitant status will impact the goal achieving rate for DM patients.~     Besides that, we are going to find out preliminary data about other markers change; small~     dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C~     that may explain the impact of triglyceride. Adiponectin is another good marker related with~     obesity and metabolic syndrome.~   "
138669|NCT01239836|"~     Urinary incontinence is a common and bothersome condition that remains frequently untreated~     among senior women. The aim of this trial is to compare the effectiveness of two~     community-based continence promotion interventions aimed at improving rates of self-care~     and/or professional health-care seeking in older women with urinary incontinence. The main~     hypothesis posits that participation in a constructivist interactive workshop combined with~     use of an evidence-based self-management tool will yield rates of improvement in~     incontinence frequency and reduce the cost of pad use by 20% compared to either intervention~     alone, which individually are expected to yield minimal effect sizes of at least 0.3~     compared to a sham intervention.~   "
138670|NCT01239823|"~     The purpose of this randomized, controlled trial is to determine whether a vibration~     platform exercise program will be more effective than a standard platform exercise program~     in improving quadriceps strength in women age 45-60 who have risk factors for knee~     osteoarthritis. Each platform exercise program will be conducted 2 times a week for 12~     weeks. The sessions will consist of a series of exercises on a Wave Pro-elite vibration~     platform (with 1-3 minute rests between sets) and stretches with the platform vibration~     either turned on (intervention group) or off (control group.) Quadriceps strength (primary~     outcome), leg press power, and vibration sense will be assessed at baseline and 12 weeks,~     and changed scores will be compared between groups.~   "
138687|NCT01239602|"~     Stem cell theray in old stroke patients is a study to treat stroke patients approved before~     in our hospital. We recruit these patients who received stem cell therapy and completed the~     study. We adopted movement-related cortical potential,and cortico-cortical inhibition to~     assess the stroke patients with or without stem cell therapy. Further analyzing the~     correlation of the motor related cortical potential and cortico-cortical inhibition among~     them. We wanted to find out if there are changes in cortical excitability in subjects with~     chronic stroke after stem cell therapy.~   "
138671|NCT01239810|"~     Objective:~      To assess the impact of intraarticular hyaluronic acid (HA) on clinical outcome and on~     volumetric and T2 relaxation based changes of articular cartilage in mild to moderate~     osteoarthritis (OA) of the knee joint.~      Methods:~      Patients with moderate OA of the knee [Kellgren-Lawrence II] were recruited for a 6-months~     prospective, randomized clinical trial evaluating the effect of HA on articular cartilage~     morphology and composition. Clinical examinations and MRI were performed at baseline, and~     after 6, 12 and 24 weeks. Cartilage volume, thickness and surface area were determined in~     cartilage plates and subregions were defined using proprietary software. MRI was performed~     on a 1.5 Tesla scanner; morphological evaluation was performed using 3D T1-w FLASH~     Waterexcitation (WE) sequences and T2 maps were calculated from a multiecho, spin-echo~     sequence.~   "
138672|NCT01239797|"~     The purpose of the study is to determine whether the addition of Elotuzumab to~     Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).~   "
138673|NCT01239784|"~     The purpose of this project is to investigate the feasibility of using a home-based,~     parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants~     who have had surgery for a complex heart defect.~   "
138674|NCT01239771|"~     The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214~     in medically stable elderly subjects following multiple oral doses.~   "
138675|NCT01239758|"~     To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with~     Duchenne muscular dystrophy (DMD) who participated in Study A031-03. [Note: This study was~     terminated based on preliminary safety data. Pending further analysis of safety data and~     discussion with health authorities, a new ACE-031 trial will be planned.]~   "
138676|NCT01239745|"~     This non-interventional study will be conducted in several Eastern European countries to~     assess the safety, tolerability and efficacy of Aromasin® when it is administered in~     real-word setting in postmenopausal women with invasive estrogen receptor positive early~     breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and~     continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal~     therapy, to understand how Aromasin® is used in routine clinical practice, to assess~     adherence to prescribed Aromasin® treatment and to understand reasons for its early~     discontinuation.~   "
138677|NCT01239732|"~     This open-label, non-comparative, multi-center study will assess the safety profile and~     efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in~     participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal~     carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously~     (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under~     the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a~     maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3~     weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug~     will be 108 weeks or until disease progression or unacceptable toxicity.~   "
138678|NCT01239719|"~     The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine~     fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of~     allergic dermatitis.~   "
138679|NCT01239706|"~     Prospective, Open Label, Cohort Study in Traumatic Brain Injury Patients. The goal of this~     study is to assess the safety of NTx®-265. NTx®-265 will be administered over 9 days, and~     patients will be followed for an additional 6 months.~   "
138680|NCT01239693|"~     The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have~     been associated with improved growth and development outcomes among infants in Ghana and~     Malawi. Modified versions of such supplements have been developed to improve their nutrient~     density and quality and to lower their costs. Such modified products have proven acceptable~     to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test~     the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating~     women and their infants from 6 to 18 months of age. In control groups, participants will~     receive either iron+folate tables during pregnancy only or multiple micronutrient tablets~     during pregnancy and first six months of lactations. The main hypothesis to be tested~     suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS~     between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and~     the first 6 months of lactation is higher than the mean LAZ score of same age infants who~     received no dietary supplements and whose mothers received iron-folate supplementation~     during pregnancy only.~   "
138681|NCT01239680|"~     Overall aim of this work is to evaluate new methods of resuscitation that can be applied by~     front-line responders on the battlefield, in civilian life, or which can be used during~     initial resuscitation in the first fixed facility to which the injured patient is brought.~   "
138682|NCT01239667|"~     Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for~     rehabilitation in Phase III based on identification of self-care behavior patients with~     heart failure in NYHA class II and III, leading to patients' self-care behaviors~     strengthened, which will result in increased health status and ADL level 6 months after~     discharge from hospital with heart failure .~      Target~        1. To develop evidence-based clinical guidelines for patient rehabilitation phase III~        2. To test the effect of individual rehabilitation plans based on clinical guidelines for~          patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in~          self-care behaviors, health status and ADL function.~      Material and Methods:~      Controlled longitudinal study. Each intervention patient receives before the end of hospital~     rehabilitation designed a specific rehabilitation plan also contacted the patient by~     specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in~     hospital and the patient has the opportunity to contact the department when needed. The~     effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to~     assess patients' ADL functioning, self-care behaviors and self-rated health.~      All patients participating in the planned rehabilitation in hospitals, so that the baseline~     is the end of Phase II. Intervention based on an analysis of the individual's need for~     continued rehabilitation (self care behavior, health status, ADL function) and the patient's~     perception of own situation. Draw up a plan and program together with the patient~   "
138683|NCT01239654|"~     It is an exploratory study evaluating a biological effect (stent strut coverage) using a~     novel technology such as OCT without any clinical implication.~   "
138688|NCT01239589|"~     This study is being carried out to find out how patients suffering from the acute manic~     phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or~     Quetiapine Extended Release (XR) in the hospital setting in real life practice, including~     length of stay.~   "
138689|NCT01239563|"~     The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline)~     administration in the kidney transplant recipient is able to reduce the amount of damage~     that kidneys transplanted from deceased donors sustains on reperfusion.~   "
138690|NCT01239550|"~     The purpose of this study is to evaluate the effects of the medication insulin detemir on~     weight, brain function and mood, and on blood vessel and other risk factors for heart~     disease. The study will compare how diet and insulin detemir affect areas of the brain that~     are involved in food intake and the sense of pleasure people get from eating.~      Participants will be randomized into one of 2 groups. Group 1 will follow a low calorie diet~     only. Group 2 will follow a low calorie diet and take insulin detemir.~      The study is 26 weeks in length and include outpatient visits, inpatient visits, phone and~     email contact, questionnaires, diary collection, blood draw and procedures involving MRI and~     PET scans. There are 4 inpatient visits at the Vanderbilt Clinical Research Center (CRC).~     The inpatient visits require a one night 2 day stay on the CRC at Weeks 2, 6, 16, 26. During~     the weekly and bi-weekly outpatient visits participants will meet with the study nurse and~     dietitian.~   "
138691|NCT01239537|"~     In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu)~     outbreak the first global pandemic of this century. It is thought to have been responsible~     for 16,226 deaths globally as of 21st February 2010. The investigators know from previous~     influenza outbreaks that the number of cases also tends to increase during the winter season~     of the years after a pandemic. There is concern that last year's pandemic influenza strain~     will return this winter and it has, therefore, been included in WHO's recommendations for~     seasonal influenza vaccine combinations.~      This study will assess the duration of the immune response to the H1N1 influenza vaccines~     given last year, and how children will respond to this year's seasonal trivalent influenza~     vaccine (which includes the H1N1 strain). Participating children would receive one dose of a~     licensed seasonal influenza vaccine and blood tests would be taken before and after~     vaccination.~   "
138692|NCT01239524|"~     Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely~     used reconstruction method. It is controversial if surgical denervation by transecting the~     thoracodorsal nerve should be performed or not. It is assumed that after denervation the~     latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand~     discomforting signs and symptoms from muscle contraction are believed to be prevented if~     flap is denervated. The aim of the study was prospectively evaluate the influence of LD-flap~     innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to~     compare the change in muscle structure in breast MRI and histopathology.~   "
138693|NCT01239511|"~     The objective of this study is to evaluate the dose-response of three different dose levels~     of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in~     patients with chronic stable angina.~   "
138694|NCT01239498|"~     The investigators hypothesize that injection of saline to the upper eyelids prior to~     lidocaine/adrenaline injection will reduce pain of the local anesthetic in comparison to~     injection of lidocaine alone.~   "
138695|NCT01239485|"~     The purpose of this study is to determine the maximum tolerable dose of irinotecan in~     combination with etoposide, cytarabine for refractory or relapsed acute leukemia in~     pediatric patient.~   "
138696|NCT01239472|"~     Currently, acute kidney injury is diagnosed by increased serum creatinine. However,~     creatinine is not a reliable marker for acute changes in renal function.~      The biology of the renal graft is influenced by chemokines from reperfusion and throughout~     its course with the development of interstitial fibrosis and tubular atrophy ubiquitously~     present in grafts of long-term survival. Moreover, the evaluation of changes in urinary~     cytokines may predict renal function and acute rejection episodes and their response to~     treatment.~      Today there are several studies comparing the relative immunosuppression of renal function,~     but few noticed its relationship with cytokines and chemokines. Thus, we propose to study~     the inflammatory consequences on blood and urine with the early withdrawal of calcineurin~     inhibitors (ICN), with renal biopsy in renal transplant patients before the change of~     immunosuppression and 9 months after.~   "
138697|NCT01239459|"~     Primary Objective:~      - To determine the effect of severe renal impairment on the pharmacokinetic profile of~     teriflunomide administered as a single 14 mg dose as compared to healthy subjects~      Secondary Objective:~      - To assess the tolerability of teriflunomide administered as a single 14 mg dose in~     subjects with severe renal impairment compared to subjects with normal renal function.~   "
138698|NCT01239446|"~     Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery~     disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time~     of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia~     and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and~     those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature~     CAD and likely may benefit from coronary assessment.~      A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the~     individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the~     lesion detectability and sensitivity in patients with balanced diffuse lesions as well as~     the specificity and mainly PPV of CTCA.~      The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who~     have received radiotherapy to the mediastinum in order to allow an early diagnosis of~     hemodynamically significant CAD that will need further therapeutic interventions.~   "
138699|NCT01239433|"~     Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this~     study pressure changes are examined in a mechanical lung model and in a population of ICU~     patients on mechanical ventilation.~   "
138700|NCT01239420|"~     The purpose of this study is to evaluate the use of combined clinical-neurological,~     neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio-~     and/or respiratory arrest.~   "
139156|NCT01233414|"~     The purpose of this 24 week study is to determine whether a new Parent Training program is~     effective in reducing disruptive behaviors in young children with pervasive developmental~     disorders.~   "
138701|NCT01239407|"~     The purpose of this study is to determine if a culturally focused psychiatric (CFP)~     consultation service can improve depressive symptoms and increase diagnosis and treatment of~     depression in Asian American and Latino American primary care patients at the Massachusetts~     General Hospital.~   "
138702|NCT01239394|"~     Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of~     cancerous B cells, and then triggering the death of those cells. It is approved by the FDA~     for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence~     of success in people who's B-cell lymphomas have relapsed after initial treatments. In this~     research study we are looking to see if ofatumumab is effective and safe in treating~     previously untreated B-cell NHL.~   "
138703|NCT01239381|"~     Stereotactic body radiation therapy (SBRT) is a technique that is used to deliver radiation,~     to sites in the body. All participants in this study will be treated with SBRT using proton~     beam radiation. Proton beam radiation uses tiny particles to deliver radiation to tumors.~     The purpose of this research study is to determine if SBRT with protons will prevent tumor~     growth and reduce the treatment side effects for liver metastases.~   "
138704|NCT01239368|"~     Background:~      - Cancer development is associated with problems in immune system functions, which prevent~     the body from attacking and destroying the abnormal cells that lead to tumor growth.~     Research has suggested that certain white blood cells, known as Th1 and Th2 T cells, are~     affected in individuals with some kinds of cancer -- when the proportion of Th2 cells is~     greater than Th1 cells, the immune system s ability to fight off the growth of malignant~     tumors is weakened. Researchers are interested in determining if an infusion of specially~     modified Th1 cells, in addition to stem cell transplant, is a safe and effective treatment~     for individuals with forms of multiple myeloma that might not respond well to standard~     treatments alone.~      Objectives:~      - To determine the safety and effectiveness of the infusion of modified Th1 white blood~     cells, in conjunction with standard treatment, as a treatment for individuals who have been~     diagnosed with high-risk forms of multiple myeloma.~      Eligibility:~      - Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and~     who have received no or minimal treatment (4 months or less) yet..~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies. Some participants may also have a bone marrow or~          other type biopsy to evaluate the state of their disease.~        -  White blood cells will be collected from the participants through an apheresis~          procedure, which will collect and separate the white blood cells and return the rest of~          the blood to the participant.~        -  The collected cells will be grown and expanded under special conditions in the~          laboratory and stored frozen until participants receive all the standard of care~          treatment for multiple myeloma, including a stem cell transplant.~        -  Participants will receive an infusion of the modified Th1 cells a few weeks after the~          transplant, and will remain in the hospital for a few days after receiving the cells to~          monitor the possible immediate effects of the treatment.~        -  Participants will have regular follow-up visits to study the long-term effects of the~          modified Th1 cell infusion.~   "
138705|NCT01239355|"~     This phase II trial is studying how well MK2206 works in treating patients with advanced~     liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
138706|NCT01239342|"~     This randomized phase II trial studies the side effects and how well Akt inhibitor MK2206 or~     everolimus works in treating patients with kidney cancer that does not respond to treatment.~     Akt inhibitor MK2206 and everolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Everolimus may also stop the growth of kidney cancer by~     blocking blood flow to the tumor. It is not yet known whether Akt inhibitor MK2206 or~     everolimus is more effective in treating kidney cancer.~   "
138707|NCT01239329|"~     Underweight is more prevalent in people with a mental handicap than in people without a~     mental handicap, especially in people with a severe mental handicap. It is unknown if these~     people are malnourished. There is no validated screening instrument available to determine~     the nutrition status in people with complex multiple disabilities. Research regarding~     malnutrition based on body composition and nutrients in stead of anthropometric data is~     important.~      The aim of the study is to understand the nutritional status of people with complex multiple~     disabilitiest through measurement of body composition and nutritients. The primary objective~     of the study is: What percentage of people with complex multiple disabilities are~     malnourished, based on altered body composition and nutritients? Understanding the~     nutritional status of these patients is important in order for them to receive appropriate~     and effective treatment. This treatment is of interest for general health and the quality of~     daily life.~   "
138708|NCT01239316|"~     This phase II trial studies how well vismodegib works in treating younger patients with~     recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.~   "
138709|NCT01239303|"~     During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy~     individuals. Improving the availability of NO might result increase splanchnic perfusion and~     prevent organ damage during exercise.~   "
138710|NCT01239277|"~     Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is~     to test whether combined nutrient intake plays an important role in stimulation of the~     muscle protein growth in elderly people; and whether it represent effective strategies to~     overcome the impaired muscle protein synthesis in elderly when compared with young subjects.~   "
138711|NCT01239251|"~     The purpose of this study is to test the ease of using a new device, called the GlowCap that~     reminds the patient to take their breast cancer hormone pill. The study will collect~     information about the experience with this device and what the patient thinks of its role in~     the daily pill taking routine.~   "
138712|NCT01239238|"~     The purpose of the present proposal was to investigate the predictive properties of markers~     in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home~     monitor assessments to measure asthma control will be examined.~   "
138721|NCT01239121|"~     Medication reconciliation, a process by which a provider obtains and documents a thorough~     medication history with specific attention to comparing current and previous medication use,~     can prevent medication-related errors and harm. The aims of this study are: 1) To adapt~     medication reconciliation to include information from a computerized regional health~     information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication~     reconciliation process and examine effects on medication errors, harm, and hospital costs,~     and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters~     (Bronx) VA providers. Findings from this project will provide an understanding of the effect~     of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide~     information on the feasibility of incorporating RHIO tool use into every day work flow for~     pharmacists and physicians.~   "
138722|NCT01239108|"~     Dose escalation study for subjects with Leukemia that has returned or has not responded to~     standard treatment.~   "
138713|NCT01239225|"~     Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges)~     of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is~     most commonly asymptomatic and can be detected randomly during screening. Its prevalence~     rate in men aged 65 years and more is 5 - 8% (3).~      The risk factors for the occurrence of AAA are male gender, advanced age, history of~     atherosclerosis, cigarette smoking and 1st degree family history (4).~      The prevalence rate is higher in patients with history of atherosclerosis of peripheral~     blood vessels and coronary arteries (5 - 7). As the size of an aneurysm increases, there is~     an increased risk of rupture, which can result in severe hemorrhage and death. The death~     rate due to rupture in the elderly population is 90% (3, 8). Elective surgical repair of the~     abdominal aortic aneurysm is associated with a death rate of 8% (9). Therefore, the~     importance of the screening of populations at elevated risk is obvious (5 - 7, 10 -14).~     Among imaging techniques, ultrasonographic screening for abdominal aortic aneurysm is~     technically simple, accurate and devoid of ionizing radiation. Ultrasonographic diagnosis of~     AAA is associated with a major reduction in the incidence of abdominal aortic~     aneurysm-related mortality (15 - 19). The sensitivity of ultrasonographic screening for~     abdominal aortic aneurysm is about 100% (19). The most common clinical indications for~     ultrasonographic screening for abdominal aortic aneurysm are a palpable abdominal mass,~     hemodynamic impairment of aortic system in lower extremities, pain in the chest, lower back~     or scrotum, and abdominal bruits.~      Ultrasonography is used to screen for aneurysms when the outer aortic diameter is more than~     3 cm (normal diameter of the aorta is around 2 cm (20). There is disagreement regarding the~     follow-up of patients after detection of abdominal aortic aneurysm in diameter of 2.6 cm -~     2.9 cm (22). Random detection of abdominal aortic aneurysm where the aortic diameter is 2.6~     cm, in men aged 65 years and more, have been associated with no risk for its future~     significant development (21). Ultrasonographic evaluation of abdominal aorta is a challenge~     for clinicians because of the need for the accurate detection of aortic diameter (20).~   "
138714|NCT01239212|"~     The primary objective of this study is to determine the pharmacokinetic profile of a 50~     mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with~     seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading~     dose of levetiracetam in term and preterm infants with seizures, and to obtain data on~     steady state drug levels of levetiracetam in neonates.~   "
138715|NCT01239199|"~     Background:~      It seems that in the infants and the young children, the increase of the Exhaled Nitric~     Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the~     risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the~     risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the~     investigators noticed at the child's a positive relation with the environmental tobacco~     smoke~      Objective: the investigators objective is to bring to light that the rise of the eNO, a non~     invasive biomarker of the bronchial inflammation, would be a risk factor expected from~     passage of recurrent wheezing of the infant and the young child (of less than 36 months old)~     towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing~     established, the investigators estimate by questionnaire the severity of the asthma, the~     personal and familial atopy, the collection of the environmental data. After allergic~     exploration (skin tests and assay of serum total and specific IgE, complete blood count),~     the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO~     analyzer. Annually, a questionnaire will be send to families to appreciate the persistence~     or the remission of the asthma. After a simple descriptive analysis of the population and a~     multifactorial descriptive analysis, the investigators shall look for the connections~     between the rise of the eNO and the various clinical, biological and environmental~     parameters known to influence the variations of this marker. Then the investigators shall~     select a set of explanatory variables for a multivariate analysis by a logistic regression~     step by step.~   "
138716|NCT01239186|"~     This study will analyse the sperm global methylation status of 62 infertile men before~     assisted reproductive techniques. Some of these patients (20%) present hypomethylation of~     H19 locus. A global methylation analysis may reveal others imprinting defects.~   "
138717|NCT01239173|"~     Converging lines of evidence have implicated the amygdala in the pathophysiology of~     posttraumatic stress disorder.~      The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic~     antagonism, on amygdala activation during a symptom provocation state in traumatized~     subjects with and without posttraumatic stress disorder.~   "
138718|NCT01239160|"~     The treatment of lymphedema has been a major focus of attention for physicians and~     scientists for several decades. At this time, no successful techniques have been developed~     to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment~     modalities that can lessen the severity and impede the progression of this debilitating~     condition.~      The treatment on offer usually consists of a maintenance phase using compression garments~     and an intensive treatment phase, which includes the use of skin care, compression~     bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually~     described as complex decongestive therapy (CDT). This is time consuming and requires high~     resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be~     used by the patient. There are a number of devices on the market that are categorized into~     1. without calibrated gradient compression 2. With calibrated gradient compression.~      This trial will compare two PCDs, a simple device without calibrated compression, and an~     advanced device with calibrated compression, in the reduction of swelling and maintenance of~     reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will~     be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.~   "
138719|NCT01239147|"~     Epidemiological studies suggest that whole grain consumption affects measures of obesity~     including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate~     rather consistently an inverse association between BMI and whole grain consumption.~     Furthermore, prospective cohort studies suggest that people with high whole grain~     consumption have less risk for body weight gain compared with low whole grain consumption.~      The purpose of this study is to assess the effects of inclusion of whole grain in the diet~     on anthropometric measures, particularly abdominal fat regain after a weight loss diet.~      It is anticipated that the short-term regain of abdominal fat after a weight loss diet is~     lower in volunteers consuming whole grain than in volunteers consuming refined grain.~   "
138720|NCT01239134|"~     TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose~     escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or~     other solid tumor malignancies. The study objectives are to determine the safety,~     tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of TRX518 and to define~     the maximum tolerated dose at which there are tolerable side effects and/or maximum PK/PD~     parameter changes.~      Subjects will be assigned to a cohort in the order screening is completed. Dose will depend~     upon the cohort in which a subject is enrolled and cohorts will be dosed consecutively by~     ascending dose.~      MSKCC Study #10-147~   "
138723|NCT01239095|"~     Colorectal cancer is the third most common form of cancer found in the United States. To~     date surgical resection provides the best chance for cure. Unfortunately, despite curative~     surgery, tumor recurrences develop in 30-40% of patients from either unforeseen residual~     metastases or from viable tumor cells shed into the circulation before or at the time of~     surgery. There is evidence from both humans and mice suggesting that tumor growth is~     stimulated after surgery for a period of time.~      This study calls for the administration of a green tea extract and a milk thistle extract,~     two orally ingested supplements, during the week immediately before and weeks after your~     surgery. It is not the current standard of care to give anti-cancer drugs during the~     perioperative period. The basic idea behind this study is that it should be beneficial to~     inhibit cancer growth in the days leading up to and following surgery. Why is this the case?~      It makes sense to limit or inhibit tumor growth before surgery with drugs provided it can be~     done safely and does not interfere with the surgery. It is also logical to give anti-cancer~     drugs after surgery because, unfortunately, about 35 percent of colorectal cancer patients,~     after resection, have hidden tumor cells that remain in the body. There is also strong human~     evidence that tumor growth is stimulated during the first month after tumor resection as a~     result of the surgical injuries and the healing process. Therefore, there is good reason to~     give anti-cancer drugs as soon as possible after surgery in order to offset some of~     surgery's negative effects.~      Although both supplements have been given safely to a wide variety of patients with a number~     of different medical problems, the two supplements together have never been given to cancer~     patients during the weeks just before and following surgery. We hypothesize that the~     administration of these two supplements together will be safe in the period surrounding~     colorectal cancer surgery.~   "
138724|NCT01239082|"~     Colorectal cancer (CRC) is currently the second most common cause of cancer death in the~     United States, and one of the most preventable cancers. It has been shown in several~     randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces~     CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value~     of CRC screening, the best approach to screening is not clear. Of the widely recommended~     modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT~     is inexpensive, non-invasive, and its use as a screening tool is supported by the highest~     quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal~     immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test~     characteristics and ease of use that make them quite attractive as a population-based~     screening tool.~      While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does~     afford the opportunity to directly assess the colonic mucosa and is widely believed to be~     the best test to detect colorectal cancer. In addition, colonoscopy allows for the detection~     and removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is~     indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer~     mortality, but to date, no large clinical trials have been completed to support this~     assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not~     be as effective as previously believed. Prior support for colonoscopy as a screening test~     relied upon effectiveness estimates that now appear to be overly optimistic. Given the~     invasive nature of colonoscopy, the associated small, but real risk of complications, and~     dramatically higher costs than other screening tests, it is especially important to~     determine the true comparative effectiveness of colonoscopy relative to other proven~     non-invasive options.~      The investigators propose to perform a, large, simple, multicenter, randomized, parallel~     group trial directly comparing screening colonoscopy with annual FIT screening in average~     risk individuals. The hypothesis is that colonoscopy will be superior to FIT in the~     prevention of colorectal cancer mortality measured over 10 years. Individuals will be~     enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past~     10 years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The~     investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or~     symptoms of CRC, first degree family member with CRC, personal history of colorectal~     neoplasia or inflammatory bowel disease).~      All participants will complete baseline demographic, medication, and lifestyle~     questionnaires (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior~     to randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening~     (Figure 1). Those testing positive by FIT will undergo evaluation to determine~     appropriateness for colonoscopy. Screening will be performed in a manner consistent with the~     currently accepted standard of care in order to determine the comparative effectiveness of~     the two screening strategies. Participants will be surveyed annually to determine if they~     have undergone colonoscopy or been diagnosed with CRC.~      The primary study endpoint will be CRC mortality within 10 years of enrollment. The~     secondary endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major~     complications of colonoscopy. Mortality will be determined through queries of the VA Vital~     Status File. Cause of death will be determined primarily using death certificates from the~     National Death Index-Plus database, augmented by adjudication of medical records for known~     CRC cases where CRC is not listed as a cause of death on the death certificate. The~     investigators postulate that screening colonoscopy will result in a 40% reduction in CRC~     mortality over 10 years relative to annual FIT screening. Using a log-rank test with a~     2-sided test of significance, =0.05, a sample size of 50,000 participants will be required~     to test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from~     FIT to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration~     is 12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled~     participants.~   "
138725|NCT01239069|"~     Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for~     the Treatment of Dry Eye Disease~   "
138726|NCT01239056|"~     The purpose of this study is to study the evaluation of the effectiveness of endoscopic~     Pancreatic Pseudocyst drainage using a metal stent.~   "
138727|NCT01239043|"~     The purpose of this trial is to describe antibody persistence and response to re-vaccination~     with either Menactra® or Menomune® vaccine approximately three years following initial~     vaccination in adults who participated in trial MTA29 (NCT00874549).~      Objectives:~        -  To describe the rates of immediate reactions, solicited injection-site and systemic~          reactions, all unsolicited adverse events, and serious adverse events following~          vaccination.~        -  To evaluate persistence of serum bactericidal antibodies in subjects who received~          Menactra® or Menomune® vaccine approximately three years ago.~        -  To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects~          re-vaccinated with either Menactra® or Menomune® vaccine.~   "
138728|NCT01239030|"~     This multi-center parallel study is designed to study the efficacy and safety of fixed doses~     of methylphenidate extended release (ER)capsules of three dose levels compared with a~     placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who~     are between 6 and 18 years old.~   "
138729|NCT01239017|"~     This is a double-blind, prospective, randomized study in which patients will be randomized~     to 1 of 5 treatment arms (4 active and 1 placebo).~      Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either~     REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving~     REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive~     placebo SC.~   "
138730|NCT01239004|"~     The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering~     effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic~     control in dyslipidemic subjects with impaired fasting glucose.~   "
138731|NCT01238991|"~     The purpose of this long term extension study is to assess safety, tolerability and~     immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD~     who were randomized in the preceding P2 double blind studies.~   "
138732|NCT01238978|"~     The study will assess the incidence of Hypoglycemia: Percent of patients presenting no~     hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in~     T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin~   "
138733|NCT01238965|"~     Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving panobinostat together with fluorouracil and leucovorin~     calcium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects~     and the best dose of giving panobinostat, fluorouracil, and leucovorin calcium together in~     treating patients with stage IV colorectal cancer who did not respond to previous~     fluorouracil-based chemotherapy.~   "
138734|NCT01238952|"~     The primary objective is to determine the maximum tolerated dose/recommended phase II dose~     of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.~   "
138735|NCT01238939|"~     The primary objective is to determine the maximum tolerated dose/recommended phase II dose~     of the combination regimen of NK012 and 5-fluorouracil in patients with advanced solid~     tumors.~   "
138736|NCT01238926|"~     This experiment seeks to determine whether individuals with PD will benefit from vitamin B6~     (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether~     they will benefit from a 6-week circuit training program, or whether they will benefit from~     a combination of the two interventions. The outcome variables will include: plasma~     homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities,~     kinematic gait analysis, and a quality of life questionnaire.~   "
138737|NCT01238913|"~     The evaluation of using metal stents as medically indicated for the treatment of benign~     esophageal lesions.~   "
138738|NCT01238900|"~     The purpose of this study is to study the evaluation of the use of metal stents as part of~     the treatment of benign biliary strictures.~   "
138753|NCT01238705|"~     This randomized,active controlled study aimed to compare the effects on sexual function of~     treatment with combined antihypertensive drugs.~      The researchers hypothesize that:~        1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are~          effective in lowing blood pressure in patients with essential hypertension.~        2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of~          sex hormone,whereas felodipine-irbesartan combination does not impair sexual function~          and does not change hormone levels.~        3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan~          combination has a greater impact on oxidative stress indicators than~          felodipine-metoprolol combination.~   "
138925|NCT01236456|"~     The primary endpoint of this study is to determine what percentage of patients receiving~     high-dose Cyclophosphamide may experience a halt in the worsening of their disease or~     experience improvement of their disease and for how long the benefit may last.~   "
138739|NCT01238887|"~     Despite widespread efforts to improve the treatment of obesity, only limited progress has~     been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as~     well as delay the onset of age-related diseases, in numerous species. Most overweight~     individuals, however, are unable to sustain CR induced weight losses, possibly due to~     internal feedback systems that signal the body to increase food intake or decrease energy~     expenditure in response to weight loss. Novel treatment approaches are thus urgently needed~     that can assist overweight individuals in adhering to a CR regimen over the long-term.~      Botanicals represent an important and underexplored source of potential new therapies that~     may facilitate CR. In particular, one promising botanical that may reduce food intake and~     body weight by affecting neuroendocrine pathways related to satiety is Garcinia Cambogia~     (Garcinia Cambogia Desr.)-derived (-)-hydroxycitric acid. This compound has been found to~     facilitate weight loss in a number of studies. To date, few studies have directly tested the~     effect that this botanical on food intake in humans, its mechanism of action, or its effect~     on oxidative stress levels; thus rigorous scientific studies on this compounds need to be~     conducted. A double-blind, placebo-controlled crossover study will be conducted to explore~     the role that two different doses of this botanical compound have on food intake, satiety,~     weight loss, and oxidative stress levels. It is hypothesized that compared to placebo, both~     doses of Garcinia Cambogia (hydroxycitric acid) will reduce food intake, increase satiety,~     decrease weight, and reduce oxidative stress levels.~   "
138740|NCT01238874|"~     The Latin America CRT Study is a prospective, multicenter, interventional post-market~     release study conducted in Latin America. The geography includes Puerto Rico and the~     Caribbean, Mexico and Central America, and South America.~   "
138741|NCT01238861|"~     The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous~     administrations of MEDI-563 on adults with uncontrolled asthma.~   "
138742|NCT01238848|"~     The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline~     in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital~     stay, oxygen requirements and clinical outcome.~   "
138743|NCT01238835|"~     A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating~     the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), the next~     generation Ascendra™ transapical delivery system, and crimper accessories.~   "
138744|NCT01238822|"~     Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of~     neuropsychological dysfunction including response inhibition, working memory, and attention.~     One neuropsychological outcome measure that consistently reveals between-group differences~     is response variability. However, until recently, differences in response variability have~     been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific~     aims of the present study are to 1) Examine response variability in ADHD patients across~     neuropsychological tasks to understand the breadth of this specific deficit and to~     understand the relation between response variability and other neuropsychological outcome~     measures; 2) Assess whether response variability deficits are specific to either or both of~     the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive~     Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by~     either medication or a variety of environmental manipulations (e.g., reward); and 4)~     Understand the relationship between neuropsychological measures of response variability and~     naturalistic instances of variable performance. Forty-five children (aged 7-11) with~     ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine~     response variability across a wide range of neuropsychological tests. Task parameters such~     as event rate, stimulus saliency, and the presence of operant reward will be modified on~     each test to determine the conditions under which response variability is manifested in~     children with ADHD. In addition, all children with ADHD will participate in a~     placebo-controlled, randomized medication trial with a psychostimulant medication to assess~     the effects of medication on response variability. Advanced analytic methods utilizing~     non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be~     used to conduct detailed analyses of RT patterns across the ADHD and normal control groups.~     Further, the effects of task parametric manipulations and medication on response variability~     will be examined. Finally, relations between response variability on neuropsychological~     tests and response variability in a variety of real-world analog situations will be examined~     to evaluate the ecological validity of these deficits.~   "
138745|NCT01238809|"~     The purpose of this study is to assess in general population low-dose aspirin and~     gastroprotective agent compliance and reasons for bad compliance~   "
138746|NCT01238796|"~     The purpose of this study is to evaluate the effect of renal function on the biological~     activity of telavancin using blood samples obtained from subjects with normal renal~     function, severe renal impairment, and end stage renal disease.~   "
138747|NCT01238783|"~     To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for~     treatment of bacterial conjunctivitis~   "
138748|NCT01238770|"~     The current trial shall clarify the potential of the multitarget antiangiogenic~     tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as~     salvage treatment in patients with recurrent, pretreated ovarian cancer.~   "
138749|NCT01238757|"~     The purpose of this study is~        -  to document the prevalence and type of asynchronies incidence during non-invasive~          mechanical ventilation in pediatric patients breathing under pressure support.~        -  to observe the impact of adjusting the expiratory trigger setting on asynchronies~          during pressure support~        -  and compare these incidences with asynchronies measured in pediatric patient breathing~          under NAVA system (Neurally Adjusted Ventilatory Assist).~   "
138750|NCT01238744|"~     The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets~     will be tested in term of their effect on appetite sensation measured using visual analogue~     scales over 120 minutes and ad libitum energy intake hereafter in two studies.~   "
138751|NCT01238731|"~     Background: Persistent severe pulmonary hypertension (PH) after mechanical valve replacement~     is a frequent finding in patients with severe valve-diseases. The reasons to develop PH are~     multifactorial and the prevalence of severe PH significantly worsens the patients´ outcome.~      Aims: (i) To define the prevalence of PH in patients after valve replacement and (ii) to~     identify factors predicting persistent PH.~      Methods: All patients which underwent valve replacement at our institution between the years~     2008 -2010 will be screened retrospectively. Those patients with pre- procedural proven PH~     by means of right-heart catheterization will receive prospective follow-up with~     echocardiography. Diagnosis of persistent PH will be confirmed with right heart~     catheterization.~   "
138752|NCT01238718|"~     Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation.~     The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be~     increased in patients that receive rapid sequence induction and intubation, where opioids~     are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis~     was that lidocaine when administered intravenously in patients who undergo rapid sequence~     induction may not only blunt the hemodynamic response to intubation, but may also increase~     the anesthetic depth (as assessed by BIS), thus further reducing the possibility of~     hypertension, arrhythmias and also awareness.~   "
138754|NCT01238692|"~     The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and~     refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting.~     Tissue samples from accessible lymph nodes will be collected and banked before the start of~     the study treatment and after 15 days. Additionally, blood samples will be drawn and stored~     in the tissue biobank.~   "
138755|NCT01238679|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of ascending doses administered for 14 days in healthy volunteers.~   "
138756|NCT01238666|"~     This study was designed in two phases: Phase I is designed to confirm that the surgeon is~     able to perform accurate liver surface registration including standard liver features used~     as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level~     of comfort with the procedure.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained,~     the registration points obtained during this procedure will be evaluated by the surgeon by~     moving the tracked laparoscopic probe over the liver surface and evaluating the location of~     the tracked laparoscopic probe displayed on the guidance system three dimensional (3D)~     image. The surgeon will accept or reject the registration accuracy.~      The hypothesis is that the surgeon will be able to successfully acquire liver surface~     registrations with a small learning curve for technique and will be able to proceed to Phase~     II of the study.~      Phase II contains the registration process included above but adds the additional process of~     tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder~     Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked~     and displayed on the Pathfinder three dimensional (3D) image.~      The surgeon will use ultrasound (US) guidance to locate tumor location during the~     laparoscopic procedure. The images collected during this process will be recorded by~     Pathfinder.~   "
138757|NCT01238653|"~     This study was designed to confirm that the surgeon is able to perform accurate liver~     surface registration including standard liver features used as landmarks during a scheduled~     laparoscopic liver procedure. The hypothesis is that there will be no clinically relevant~     difference between the error measurements obtained during the laparoscopic procedures in~     this study when compared with those obtained during previous open liver registration~     studies.~      The surface of the liver will be manually swabbed with the study tracked laparoscopic probe~     with landmarks noted during data collection. After registration of the liver is obtained,~     the registration points obtained during this procedure will be evaluated by the surgeon by~     moving the tracked laparoscopic probe over the liver surface and evaluating the location of~     the tracked laparoscopic probe displayed on the guidance system three dimensional (3D)~     image. The surgeon will accept or reject the registration accuracy.~   "
138758|NCT01238640|"~     The purpose of this study is to assess the bioequivalence between two new oral nicotine~     replacement therapy products and Nicorette® microtab.~   "
138759|NCT01238627|"~     The purpose of this study is to assess the bioequivalence between two oral nicotine~     sublingual tablets, 2 mg and 4 mg.~   "
138760|NCT01238614|"~     The CHICA system is a clinical decision support system that uses adaptive turnaround~     documents to provide point-of-care information to clinicians. We will be studying whether it~     can help in the diagnosis and referral of mothers with maternal depression.~   "
138761|NCT01238601|"~     The purpose of this study is to determine how different types of breast implants contour to~     the chest wall.~   "
138762|NCT01238588|"~     The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will~     be associated with less inflammation including less atherosclerotic plaque inflammation~     (inflammation of the vessel walls).~   "
138763|NCT01238575|"~     The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself~     or in combination with methylphenidate (also known as Ritalin) is helpful for treating~     hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).~   "
138764|NCT01238562|"~     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a~     single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish~     dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).~   "
138765|NCT01238549|"~     The field of spinal cord injury (SCI) rehabilitation medicine lacks a reliable, patient~     reported, health-related quality of life measurement tool. The National Institute of Health~     has provided funding to develop a SCI-specific, quality of life (QOL) survey tool in~     non-Veterans with SCI called the SCI-QOL. This quality of life survey asks questions~     regarding physical/medical, emotional, and social health as it relates to individuals with~     spinal cord injury.~      The purpose of this study is to include a Veteran population in the making of the quality of~     life survey. Each participant will be asked to complete a packet of quality of life~     questions. Participants will be given the opportunity to take the survey a second time,~     either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow~     the research team to test the reliability of the survey. Comparing the SCI-QOL with other~     legacy measures will allow the investigators to test the validity of the survey.~      Additionally, the investigators will be testing the SCI-QOL between Veterans and~     non-Veterans with SCI to determine if there are differences in their self-reported quality~     of life.~      This study will be recruiting participants at the James J. Peters Veterans Affairs Medical~     Center (VAMC) in Bronx, New York and the James A. Haley Veterans Affairs (VA) Hospital in~     Tampa, Florida. The James J. Peters VAMC will be recruiting 125 participants and the James~     A. Haley VAH will be recruiting 275.~   "
138766|NCT01238536|"~     The broad, long-term objective of this research protocol is to improve the quality of life~     for patients suffering from lumbar spinal stenosis. This objective will be met by examining~     the safety and clinical efficacy of epidural steroid injections for treatment of pain~     associated with lumbar spinal stenosis. This prospective, randomized, double-blind~     controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid~     injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone~     in older adults with lumbar spinal stenosis.~   "
138926|NCT01236443|"~     A Study to identify toxicity and optimal photodynamic treatment parameters using the~     photosensitizer 2-[1-hydroxyethyl]-2-devinylpyropheophorbide-a (HPPH) in high grade~     dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.~   "
138767|NCT01238523|"~     Tibial shaft fracture is one of the most common fractures in children and adolescents. It~     encompasses approximately 15 % of all long-bone fractures and is third behind only fractures~     of the femur and both bones of the forearm. (2). Although most authorities agree that closed~     tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no~     clear consensus as to when to allow weight bearing on the injured extremity. While most~     recent articles have recommended long-leg casts with the knee bent in flexion of 30-60~     degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less~     flexion, 0-5 degrees, to encourage early weight bearing.(5).~      The purpose of this randomized controlled prospective study is to determine if the position~     of immobilization of the knee influences the rate of healing, delayed union, and nonunion As~     well, we will assess if the type of immobilization affects the function of the patient~     during the period of treatment using the Activities Scale for Kids - Performance (ASK-P)~     child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group~     for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures~     of the tibia, with or without fracture of the fibula, will be included in the study~   "
138768|NCT01238510|"~     In the setting of single stent strategy for treatment of bifurcation, we investigate to~     compare simple strategy as provisional final kissing balloon technique(fKBT) to complex~     one as routine FKBT, focusing on actual myocardial ischemia assessed by scintigraphy in~     7-month and to examine optimal endpoint of side branch ostium.~   "
138769|NCT01238497|"~     This registry is to expand upon existing data sets, to identify patient characteristics and~     indicators related to complications and clinical benefits for patients with symptomatic~     severe calcific degenerative aortic stenosis that are undergoing treatment with the~     commercially available Edwards SAPIEN XT™ Valve, and delivery devices.~   "
138770|NCT01238484|"~     The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS)~     is effective in treating contracture for patients with Ankle Equinus secondary to diabetes~     mellitus.~   "
138771|NCT01238471|"~     In premature infants, propranolol (Prop) treatment might suppress continuing~     neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP)~     towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or~     LASER photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We~     therefore plan to prospectively investigate the influence of prop versus placebo in VLBW~     infants with ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease,~     along with close follow up regarding safety of prop administration and its effect on ROP.~   "
138772|NCT01238458|"~     This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers,~     and 60 MCI(Mild cognitive impairment), and 60 AD(Alzheimer's disease), respectively) Each~     evaluable subject involved in this study must fulfill all the inclusion and exclusion~     criteria according the subject grouping.~      Safety measurement will be evaluated by medical history, vital signs, physical examinations,~     laboratory examinations and collecting of adverse events.~      This study is expected to be completed in a period of 3 years.~   "
138773|NCT01238445|"~     Bronchiolitis is a significant cause of morbidity and hospitalizations in children,~     accounting for more than 125,000 hospitalized children per year in the United States.~     Although treatment is largely supportive, bronchodilator medications such as albuterol are~     frequently used due to increased pulmonary resistance in this population.2-4 However,~     despite four decades of clinical trials, the efficacy of albuterol in the treatment of~     bronchiolitis has yet to be proven. This inconsistency is due in part to the lack of~     sufficiently sensitive methods for the evaluation of lung function and thus the response to~     albuterol in infants. Because of the difficulties in evaluating the response to therapy,~     healthcare providers are forced to rely on their physical examination skills or a clinical~     scoring system, both of which are highly subjective in this population. The investigators~     propose to conduct a prospective observational study of healthcare providers to determine~     the accuracy of clinical assessment as compared to that of pulmonary mechanics in a~     population of children intubated and mechanically ventilated for bronchiolitis.~   "
138774|NCT01238432|"~     Near fatal asthma exacerbations are one of the most common causes of critical illness in~     children, accounting for approximately ten thousand intensive care unit (ICU) admissions per~     year in the United States. Even children with intermittent or mild baseline asthma can~     develop these severe exacerbations; however, there are few studies evaluating the risk~     factors associated with the development of near fatal asthma exacerbations in children.~     Inhaled β2-adrenergic receptor (ADRβ2) agonist therapy is the foundation of therapy for~     acute asthma and genetic variations of this receptor have been shown to affect response to~     ADRβ2 agonist therapy in this population. The investigators hypothesis is that a child's~     ADRβ2 genotype is associated with the development of a near fatal asthma exacerbation.~   "
138775|NCT01238419|"~     The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison~     with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg~     ulcer.~   "
138789|NCT01238237|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. Initial~     therapy consists of either surgical resection, external beam radiation or both. All patients~     experience a recurrence after first-line therapy, so improvements in both first-line and~     salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is~     unknown if currently used intravenous (IV) therapies even cross the blood brain barrier~     (BBB). Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can~     effectively increase the concentration of drug delivered to the brain while sparing the body~     of systemic side effects. One currently used drug called, Cetuximab (Erbitux) has been shown~     to be active in human brain tumors but its actual CNS penetration is unknown. This phase I~     clinical research trial will test the hypothesis that Cetuximab can be safely used by direct~     intracranial superselective intraarterial infusion up to a dose of 500mg/m2 to ultimately~     enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this~     study the investigators will determine the the toxicity profile and maximum tolerated dose~     (MTD) of SIACI Cetuximab. The investigators expect that this study will provide important~     information regarding the utility of SIACI Cetuximab therapy for malignant glioma, and may~     alter the way these drugs are delivered to the investigators patients in the near future.~   "
138776|NCT01238406|"~     Study design: Multicenter,randomized, prospective, open label, cross over, six segments,~     pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery~     with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes.~      on the first segment 15 eligible subjects will be enrolled from the three participating~     centers (5 patients at each center). All 15 patients will participate in the overnight~     closed loop session in the hospital settings.~      On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each~     subject will participate in the two consecutive overnight sessions in diabetes camp~     settings, one under closed-loop with MDLAP and one under sensor augmented pump therapy.~      In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each~     subject will participate in up to four consecutive overnight under closed loop with MDLAP~     and up to four additional overnight under regular sensor augmented pump therapy at home.~      On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This~     segment will be conducted at a diabetes camp and will consist of two main parts. In part 1,~     15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under~     closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under~     closed loop control without activating the MD-Logic learning algorithm. In part 2 of the~     forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one~     under closed loop control and the second under sensor augmented pump therapy.~      On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The~     first 10 patients will participate in a pilot session and data gathered at this pilot~     session will not be used at the final analysis.This segment will consist of two parts. At~     part 1 each subject will participate in 4weeks-1.5 months period of over nights either using~     closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first~     4 weeks-1.5 months of the study, statistical analysis will be performed in order to decide~     whether to extend the study with an optional period of extra 4 weeks-1.5 months.In case it~     will be decided to extend the study, additional 4 weeks-1.5 months intervention period~     following completion of final visit activities will be offered to participants. Subjects~     that have participated in the control group (sensor augmented pump therapy) will be offered~     the opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group~     will be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40~     patients will be enrolled. Each patient will participate in 3 months study period either~     using overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in~     segment 5 part 2 will be offered to participate in part 2A. At this part, sleep quality~     assessment will be made (by using actigraf and sleep questionnaire) At the end of this~     period an optional 3 months extension period will be offered with the other arm (cross-over)~      Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be~     enrolled at the Israeli center only. Each subject will participate in up to 72 hours of~     closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump~     therapy . The sequence of the treatment intervention will be randomly assigned. The sequence~     of the treatment intervention will be randomly assigned. In part 2 of this segment 40~     eligible patients will enrolled at the Israeli center only. Each subject will participate in~     up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor~     augmented pump therapy. The sequence of the treatment intervention will be randomly assigned~      Objectives: The objective of this feasibility study is to evaluate the safety and efficacy~     of blood glucose control using the MD-Logic Artificial Pancreas System in individuals with~     type 1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.~   "
138777|NCT01238393|"~     The purpose of this study is to determine whether intraocular injection of ranibizumab~     decreases the retinal thickness in patients with epiretinal membranes and reduces associated~     symptoms.~   "
138778|NCT01238380|"~     Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the~     age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with~     monogenic diabetes can often be treated with tablets rather than insulin injections, leading~     to better control of their diabetes, and fewer side-effects and complications. Less than 5%~     of people with monogenic diabetes in the UK have been identified, meaning up to 20,000~     patients may still be misdiagnosed and receiving inappropriate treatment. We want to~     identify the best way of ensuring that people diagnosed with diabetes under the age of 30~     have all the necessary tests to ensure they have the correct treatment for their particular~     type of diabetes. A small number of people may, as part of this study, be found to have a~     specific genetic cause of their diabetes and in these cases we will measure the success and~     benefits of changing their treatment, usually from insulin injections to sulphonylurea~     tablets.~   "
138779|NCT01238367|"~     This trial is conducted in Japan. The aim of this clinical trial is to investigate the~     pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog~     alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.~   "
138780|NCT01238354|"~     This study focuses on the difficulties to maintain a weight loss and behavioural change~     after having been in a institutional intermittent weight loss programme.~      We explore if including a member of the family or a close friend in the treatment influences~     weight loss maintenance after completion of the programme.~   "
138781|NCT01238341|"~     In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an~     endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).~   "
138782|NCT01238328|"~     The purpose of this study is to evaluate the efficacy and side effects of donor~     hematopoietic cells using chemotherapy regimen without total-body irradiation in children~     undergoing a hematopoietic stem cell transplant for Mucopolysaccharidosis. The blood stem~     cells will be derived from either related donor or unrelated umbilical cord blood or~     haploidentical donor.~   "
138783|NCT01238315|"~     The purpose of this Phase Ib study is to determine if Human Central Nervous System Stem~     Cells(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile~     neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease~     progression.~   "
138784|NCT01238302|"~     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator~          cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in~          treatment of large to massive rotator cuff tears.~        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after~          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall~          satisfaction, and enhance structural integrity of repaired tendon.~   "
138785|NCT01238289|"~     The purpose of this study is to evaluate the effect of a culturally sensitive diabetes~     self-management program on glucose control and metabolic parameters in low income~     Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost,~     peer-educator format.~   "
138786|NCT01238276|"~     This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft~     tissue infections. In this study, cefazolin is delivered directly to the target tissues~     using subcutaneous injection of antibiotic solution and then dispersed using high-frequency~     external ultrasound. Using this system, a much higher concentration of antibiotic can be~     achieved than through traditional treatment methods.~      Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood~     supply and is beneficial for subjects with Diabetes or subjects who have received radiation~     therapy and blood supply is limited.~   "
138787|NCT01238263|"~     Recently, IgE-type autoantibodies against self proteins have been detected in the serum of~     the atopic dermatitis patients. The role of this IgE autoantibodies involved in the~     pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between~     the severity of the disease and the serum levels of this autoantibodies. The autologous~     serum skin testing is applied to both atopic dermatitis patients and healthy control and the~     results are estimated in this study.The investigators detected 70% positive autologous serum~     skin testing in atopic dermatitis patients and test positivity was higher in patients with~     atopy history, moderately severe disease calculated by SCORAD index and high serum IgE~     levels.~   "
138788|NCT01238250|"~     The Simons Variation in Individuals Project (VIP) is characterizing the medical, behavioral,~     and learning features of individuals with specific documented genetic changes associated~     with features of autism and developmental delay with the goal of improving clinical care and~     treatment for these individuals.~   "
138790|NCT01238224|"~     An increase of blood flow and capillary permeability decrease the impact of an endothelial~     barrier for glucose and insulin allowing them to reach their target cells in peripheral~     insulin sensitive organ in the human body. It is well known that insulin-resistant type 2~     diabetes patients have an impaired blood flow in skeletal muscle and it is therefore~     important to elucidate means to reverse this metabolic defect.~      The investigators have in a recently published study in type 2 diabetes patients used a drug~     against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several~     vascular territories, to increase muscle blood flow in type 2 diabetes patients who were~     studied after fasting overnight.~      The aim of this study is to test the hypothesis that tadalafil, compared to placebo,~     increases muscle glucose uptake and lowers blood glucose following a mixed meal served to~     type 2 diabetes patients.~   "
138791|NCT01238211|"~     This phase II trial studies the side effects and how well giving combination chemotherapy~     together with dasatinib works in treating patients with newly diagnosed acute myeloid~     leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Dasatinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving combination chemotherapy together with~     dasatinib may kill more cancer cells.~   "
138792|NCT01238185|"~     RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash~     in treating patients with oral leukoplakia.~   "
138793|NCT01238172|"~     RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients~     with prostate cancer.~      PURPOSE: This randomized clinical trial is studying how well diet works in altering disease~     progression in patients with prostate cancer on active surveillance.~   "
138794|NCT01238159|"~     The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed~     by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.~   "
138795|NCT01238146|"~     This phase I/II trial is studying the side effects and the best dose of obatoclax mesylate~     when given together with rituximab and bendamustine hydrochloride to see how well it works~     compared with rituximab and bendamustine hydrochloride alone in treating patients with~     relapsed or refractory non-Hodgkin lymphoma. Obatoclax mesylate may stop the growth of~     cancer cells by blocking some of the proteins needed for cell growth. Monoclonal antibodies,~     such as rituximab, can block cancer growth in different ways. Some find cancer cells and~     help kill them or carry cancer-killing substances to them. Others interfere with the ability~     of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine~     hydrochloride, also work in different ways to stop the growth of cancer cells, either by~     killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with~     rituximab and bendamustine hydrochloride may kill more cancer cells~   "
138796|NCT01238133|"~     This phase I trial studies the side effects and the best dose of gamma-secretase inhibitor~     RO4929097 when given together with paclitaxel and carboplatin in patients with stage II or~     stage III triple-negative breast cancer. Gamma-secretase inhibitor RO4929097 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs use in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving gamma-secretase inhibitor RO4929097 together with paclitaxel and~     carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
138797|NCT01238120|"~     A combination of low-does ibuprofen along with a structured home-based walking and~     progressive resistance exercise program, EXCAP, will be effective in reducing cognitive~     difficulties among cancer patients receiving chemotherapy.~   "
138798|NCT01238107|"~     A phase II clinical study to evaluate MT-102 administered over a sixteen week period in~     subjects with cachexia related to non-small cell lung cancer and colorectal cancer~   "
138799|NCT01238094|"~     The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs~     XELIRI/FOLFIRI + placebo.~   "
138800|NCT01238081|"~     Respiratory viruses, such as those that cause colds and influenza, are very common in the~     general population. The average adult will experience between 2 and 4 viral respiratory~     illnesses each year. It is known that respiratory viruses can cause flare-ups of chronic~     lung diseases such as asthma and chronic obstructive pulmonary disease. In children with CF,~     respiratory viral infections have been identified in nearly half of all exacerbations and~     are associated with a decline in lung function and increased frequency of hospital admission~     and acquisition of new bacterial pathogens.~      Currently, little is known about the impact of viral infections on the course of CF lung~     disease in adults and no large-scale prospective studies in this area have been performed to~     date. It is unknown how often respiratory viruses can be found in patients with CF when they~     are well and what consequences they have on the course of exacerbations of CF lung disease.~     This study will identify the frequency of common viral infections in adults with CF and~     determine the effects they have on lung function, the rate and diversity of bacterial~     infection and patients' treatment burden. The information gained from this study will lead~     to improved prevention and treatment of respiratory infections in CF.~   "
138801|NCT01238068|"~     The study hypothesis is the the results of the use of Gamma nail will be superior to the use~     of Dynamic hip screw for unstable intertrochantric hip fracture.~   "
138802|NCT01238055|"~     The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in~     the treatment of advanced gastric cancer patients who had prior chemotherapy with~     fluoropyrimidine and platinum.~   "
138803|NCT01238042|"~     Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's~     Esophagus are injected with HPPH and one day later are endoscopically treated with light~     from a laser.~   "
138804|NCT01238029|"~     The purpose of the study is to investigate safety and efficiency of the triple combination~     of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.~   "
138805|NCT01238016|"~     The trial aims at measuring the safety and performance of the Hyposafe device.~   "
138806|NCT01238003|"~     Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis~     of patients who have a high level of suspicion for ANCA-related vasculitis. In these~     patients the specificity and sensitivity to the ANCA test is very high. This study hopes to~     prove that when this lab test is performed on blood of patients who do not have a high level~     of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and~     there are many false positive results. Because of this, it should not be used as a screening~     test for a more general patient population.~   "
138807|NCT01237990|"~     This study was designed to confirm that the surgeon is able to perform surface registration~     of standard liver features used as landmarks during a scheduled laparoscopic liver~     procedure. Additionally, registrations will be obtained with full insufflation pressure and~     with half insufflation pressure during the laparoscopic procedure. Under the presence of~     both insufflation pressures, the surface of the liver will be manually swabbed with the~     study tracked laparoscopic probe with landmarks noted during data collection. After~     registration of the liver is obtained, the registration points obtained during this~     procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the~     liver surface and evaluating the location of the tracked laparoscopic probe displayed on the~     guidance system 3D image. The surgeon will accept or reject the registration accuracy. Upon~     completion of the scheduled laparoscopic procedure, the subject will then undergo the open~     procedure scheduled for the surgical case. An open liver registration will be obtained with~     manual swabbing of the liver using the study tracked probe and will be accepted or rejected~     by the surgeon using the process described in the laparoscopic procedure.~      In the event that the disease is determined to be too great for surgical repair during the~     laparoscopic staging procedure, only minimally invasive liver surface data will be acquired~     and the patient will not be included in the overall study population.~   "
138808|NCT01237977|"~     The purpose of this study is to test the hypothesis that the efficacy and safety of~     Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.~   "
138809|NCT01237964|"~     A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures~     which result's from burn's healing process.~      So far, treatment of choice in patients with burn's created movement limiting contractures,~     concentrated around supportive care. Patients were referred to surgical intervention only if~     necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done~     under such conditions.~      This study might introduce a new kind of treatment, which can be done in ambulatory~     environment .This type of treatment might significantly improve patients' function and~     quality of life, with no need for a surgical intervention.~   "
138810|NCT01237951|"~     The goal of this clinical research study is to learn if the combination of gemcitabine,~     busulfan, and melphalan, when given before a stem cell transplant, can help to control~     refractory myeloma. The safety of this study treatment will also be studied.~   "
138811|NCT01237938|"~     This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to~     reduce mammographic density in women at high risk for breast cancer.~   "
138812|NCT01237925|"~     Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema,~     itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical~     antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and~     pruritus, including the ones caused by sunburn. The aim of the present study is to~     demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine~     maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related~     symptoms and to demonstrate the safety of both preparations.~   "
138813|NCT01237912|"~     The current study was designed to determine the exposure of adult smokers and non-smokers to~     cigarette smoke constituents through evaluation of selected biomarkers of exposure.~   "
138814|NCT01237899|"~     The purpose of this study is to investigate the safety and tolerability of LY2623091 after~     multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of~     16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind~     for LY2623091 and placebo(negative control), and open label for eplerenone(positive~     control).~   "
138815|NCT01237886|"~     Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or~     endotracheal tube or extubation) is critically important, as both prolonged ventilation and~     failed extubation are both associated with harm and risk of death. Our objective is to~     improve the safety of extubation by harnessing hidden information contained in the patterns~     of variation of heart and respiratory rate measured over intervals-in-time. Currently, to~     assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely~     performed, where the level of ventilator support is reduced, and their response is observed~     in order to help predict if they will tolerate extubation (i.e. complete removal of~     ventilator support). Given that health is associated with a high degree of variation of~     physiologic parameters (e.g. heart and respiratory rate), and illness & stress are~     associated with a loss of variability, the investigators aim to uncover the loss of~     variation as a measure of stress during SBT's. The investigators hypothesize that~     maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the~     SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV~     or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated~     feasibility, and compelling preliminary results. A website, centralized data storage and~     analysis, and a trans-disciplinary team of scientists are in place to definitively test this~     novel technology. Determination of when to extubate critically ill patients remains a~     high-stakes clinical challenge; and improved prediction of extubation failure has potential~     to save lives and reduce costs in critically ill patients.~   "
138816|NCT01237873|"~     The purpose of this study is to evaluate the long-term safety and tolerability of the~     combination of aliskiren and amlodipine given to patients with essential hypertension. This~     study is being conducted to support registration of the fixed combination of~     aliskiren/amlodipine in the treatment for hypertension in Japan.~   "
138817|NCT01237860|"~     The study is designed to evaluate the safety and efficacy of using the L300 Plus as a~     neuroprosthesis device for walking in patients following an UMN injury or disease. The~     clinical study is proposed to determine the anticipated adverse event rate and treatment~     outcomes at the conclusion of the study.~   "
138818|NCT01237847|"~     This project will test if a phone intervention can improve the medicine-taking behavior of~     teens with IBD. The investigators will study teens who are taking medicine by mouth. The~     investigators will test if two phone calls that help teens solve problems with their IBD~     medicine help to increase how often teens take their medicine. The study will also see if~     there is any extra benefit of more sessions (four compared to two). The investigators will~     ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and~     speak English. They must also take an IBD medication by mouth and have a parent who also~     wants to be in the study. Teens who agree to be in the study will fill out forms at the~     beginning (participant week 0), middle (participant week 12), and end of the study~     (participant week 20). After assessment 1, they will be randomly assigned to either receive~     2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete~     a second assessment. After the second assessment, teens who got the 2 phone calls right will~     be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens~     who were in the wait list group will get two phone sessions (participant weeks 14-18). After~     that, there will be a final assessment (participant week 20). The investigators expect the~     phone intervention sessions to reduce barriers to medicine taking, improve medicine taking,~     and improve teen quality of life.~   "
138819|NCT01237834|"~     This study will analyze a series of biological and behavioral markers in different~     populations of smokers. The study groups will differ in their cigarette consumption and~     level of nicotine dependence. This analysis will help to identify factors that might be~     important for smoking behavior and nicotine addiction. The results from this study will~     contribute to improve campaigns for smoking prevention and treatments for smoking cessation.~   "
138820|NCT01237821|"~     This research is being done to find out the safety and efficacy of two acne creams, Effaclar~     and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA~     approved for the treatment of acne.~   "
138821|NCT01237808|"~     This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients~     with AML and NPM1 mutation ineligible for intensive chemotherapy.~      Sample size: 144 patients~      Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are~     expected to be included into the trial)~      Estimated treatment duration of an individual patient: 8 months (Follow-Up period per~     patient will last additional 2 years)~   "
138822|NCT01237795|"~     This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture~     biofilm. Complete denture wearers will be instructed to brush their dentures with a specific~     toothbrush and four compositions: (1) A proprietary denture-specific paste (active~     comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each~     treatment will be used for periods of 7 days, and participants will be randomized to use~     them according to one of four sequences.~   "
138823|NCT01237782|"~     The purpose of this study is to assess if a propolis solution is able to remove plaque and~     kill microbes from complete dentures. The investigators will compare the results of the~     propolis-based denture cleanser with those obtained with an inactive solution.~   "
138824|NCT01237769|"~     In recent years emphasis has been given to investigate the role of vitamin D in areas beyond~     bone metabolism and maintenance of calcium homeostasis. Thus, vitamin D deficiency has been~     associated with risk factors for the occurrence of cardiovascular disease as well as with~     overall mortality.In addition, there are indications that a large proportion of the~     population (up to 50%) is vitamin D deficient. The measurement of vitamin 25 (OH) D3 levels~     is the best way to estimate the vitamin D actual reserves. It is worth mentioning that~     elevated levels of parathyroid hormone (PTH) [5] and reduced levels of 1,25 (OH)2 vitamin D3~     (calcitriol have also been associated with cardiovascular disease.~      The metabolic syndrome is a sum of risk factors for cardiovascular disease and is found in~     approximately 25% of the Greek population.There are a lot of data linking low vitamin D~     levels with the metabolic syndrome as a whole as well as with its individual~     characteristics. Specifically, vitamin D deficiency has been associated with increased~     incidence of hypertension, dyslipidemia, obesity, inflammation and dysglycemia.~      Many studies have explored the effect of giving vitamin D supplements on the risk factors~     associated with the metabolic syndrome and the cardiovascular disease. The results of these~     studies are conflicting and this may partially be due to different doses of vitamin D used.~     The form of vitamin D most commonly used in these studies is cholecalciferol (vitamin D3.~      Aim of the study:~      Determination of the effect of cholecalciferol (VitD3) (2200 IU/day) on metabolic parameters~     in patients with metabolic syndrome.~      Endpoints:~      The primary endpoint will be changes in metabolic syndrome parameters 3 months after~     starting treatment:~        -  Waist circumference~        -  Blood pressure~        -  Levels of fasting serum triglycerides~        -  Levels of high-density lipoprotein cholesterol (HDL-C)~        -  Levels of fasting serum glucose.~      The secondary endpoints will include changes in:~        -  The levels of low-density lipoprotein cholesterol (LDL-C) and non-HDL-C~        -  Subfractions of LDL-C [average particle size of LDL-C, levels of small dense (sd)~          LDL-C]~        -  Subfractions of HDL-C (levels of small and large particle HDL-C)~        -  The activity and levels of Lp-PLA2 (lipoprotein-associated phospholipase A2)~        -  The levels of serum apolipoprotein AI, A-II, AV, B, E, C-II, C-III and lipoprotein (Lp)~          (a)~        -  The activity of paraoxonase-1 (PON1)~        -  The concentration of pre-beta1-HDL~        -  The levels of hs-CRP (high sensitivity C-reactive protein)~        -  Oxidative stress as measured by levels of 8-isoprostane in the blood and urine and~          oxidized LDL (oxLDL)~        -  Adipokine levels (leptin, adiponectin, visfatin)~        -  Glucose homeostasis (index HOMA: fasting insulin X fasting glucose/405)~        -  The levels of glycosylated hemoglobin (HbA1c)~        -  The levels of 25 (OH) vitamin D3, of 1,25 (OH)2 vitamin D3 and PTH~        -  The levels of serum electrolytes (Ca, PO4) and the activity of alkaline phosphatase~          (ALP) in serum.~      Study population:~      The investigators will study patients with metabolic syndrome (n = 50 adults) attending the~     Outpatient Lipid and Obesity clinic at the University Hospital of Ioannina. Diagnosis of the~     Metabolic Syndrome will be based on the criteria of National Cholesterol Education Program~     Adult Treatment Panel III (NCEP-ATP III).~      All patients will be instructed to exercise and lose weight according to the NCEP-ATP III~     diet. The participants will be randomized in an open manner into one of the following 2~     treatment groups: a) cholecalciferol (VitD3) (2200 IU/day) plus lifestyle measures or b)~     only lifestyle measures. Recruitment will be completed within one year. The reassessment of~     the patients will be done 3 months after starting of treatment.~   "
138825|NCT01237756|"~     Endobronchial tube misplacement is serious complication during general anesthesia in~     pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is~     crucial. Several methods have been suggested for determination of correct ETT placement.~     However, to date, auscultation of the left and right lung is the standard of care and the~     only ubiquitary available method with an error rate of up to 12%. Electrical impedance~     tomography (EIT) is a new non-invasive method for evaluation of left and right lung~     ventilation. In this study the investigators investigate the potential role of EIT for~     proper placement of pediatric endotracheal tubes.~   "
138826|NCT01237743|"~     Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for~     definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.~     By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic~     load, TAVI is assumed to be beneficial regarding risk for neurological complications. We~     anticipated that the extensive endovascular retrograde manipulation in ascending aorta and~     aortic root would generate a detectable cerebral microembolic load, and thus an increase in~     serological markers of neuronal injury postoperatively. Our hypothesis is that there is a~     positive correlation between the total amount of cerebral microembolic events during the~     TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of~     neuronal injury. We also wish to describe the extent and distribution of microembolisms~     during the TAVI procedure using Transcranial Doppler (TCD).~   "
138827|NCT01237730|"~     Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce~     the peristomal infection rate~   "
138828|NCT01237717|"~     One interesting area is the relationship of high salt intake and central aortic blood~     pressure. High salt intake is associated development of hypertension and cardiovascular~     mortality. Central aortic pressure is better correlated with cardiovascular events and~     mortality. With recent advances in technology, it is possible to measure central aortic~     pressure noninvasively and easily. Until now there is no study to evaluate the relationship~     of high salt intake and aortic blood pressure.~      The purpose of the present study is to evaluate the relationship of high salt intake and~     aortic blood pressure and aortic stiffness.~      Subjects with or without hypertension will be enrolled for investigation. Subjects with~     hypertension should be never treated with antihypertensive medications. Subjects with~     secondary hypertension, diabetes, heart failure, high grade kidney disease, ischemic heart~     disease, and major arrhythmia will be excluded.~      Sodium intake is measured by 24 hour urinary sodium excretion, with the measurement of~     peripheral and central aortic blood pressure, and aortic pulse wave velocity.~      Salt sensitive hypertension related single nucleotide polymorphism will be analyzed to~     define the relationship with high salt intake and aortic pressure and pulse wave velocity.~   "
138849|NCT01237444|"~     The purpose of this study is designed to compare the safety, tolerability, antiviral~     activity and immunological effect of lopinavir/ritonavir plus lamivudine (3TC) versus~     standard therapy with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus~     lopinavir/ritonavir in the treatment of naïve HIV-1 infected subjects.~   "
139157|NCT01233401|"~     This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap)~     vaccine to caregivers of newborn infants during pediatric well child visits increase the~     caregivers' vaccination rates.~   "
138829|NCT01237704|"~     In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal~     carcinoma (NPC). With early detection and advances in medical care, the number of NPC~     survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing~     consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia.~     Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration,~     malnutrition and limitations to concurrent treatment such as oral medication. Given the~     existing large costs NPC patients incur to the healthcare system, dysphagia only serves to~     further inflate the soaring costs.~      In an attempt to reduce dysphagia related costs to the healthcare system, swallowing~     rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation~     approaches are commonly adopted. The first is traditional rehabilitation, which involves~     patients performing various oropharyngeal exercises aimed at improving swallowing~     physiology. The other swallowing rehabilitation approach is transcutaneous electrical~     stimulation, which entails using small amount of electric current to increase muscle~     strength while patients are engaged in swallowing activities. These two methods are proven~     as effective in patients with stroke and head and neck carcinoma patients. Neither of these~     methods, nevertheless, yields any efficacy studies in treating NPC patients. Yet, clinicians~     continue to use either one or both rehabilitation methods as swallowing rehabilitation.~      This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC~     patients post radiotherapy. The research results should provide justification for~     rehabilitation time, clinicians' efforts, costs involved and resources used in~     rehabilitating the swallowing difficulties of the NPC patients.~   "
138830|NCT01237691|"~     The phase I evaluation is intended to assess whether or not frequent drug testing and~     immediate short-term incarceration for drug use and/or other violations and mandated drug~     treatment for multiple violations, reduces the recurrence of drug use and/or other violation~     behaviors by California parolees assigned to the study group.~   "
138831|NCT01237678|"~     The purpose of this study is to test safety and efficacy of this combination treatment~     (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small~     cell lung cancer.~   "
138832|NCT01237665|"~     This is a prospective open label single-arm, single-institution phase II clinical trial to~     test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda],~     Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable~     non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.~   "
138833|NCT01237652|"~     During or after surgery, patients may suffer heart attacks or other heart complications,~     increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in~     1990.Many risk factors have been identified but there are no properly conducted studies to~     look at Blood pressure (BP) as a risk factor around the time of surgery. The investigators~     believe there is a good possibility that systolic BP (SBP) is a risk factor but currently~     unrecognized. When measuring BP, two numbers are obtained. The upper number is called SBP~     and a lower number called diastolic BP (DBP). If the numbers are high, this means that the~     patient has a high BP or hypertension. If the SBP is high while DBP is normal, it is called~     isolated systolic hypertension (ISH)> ISH is increasingly recognized as a major risk factor~     for heart problems. The relationship between ISH and heart complications around the time of~     surgery is poorly understood. Previous studies did not look at such a relationship. Because~     of that, there are no guidelines for ISH management at the time of surgery. Generally, these~     patients go through surgery as if they have no increased risk. Studies are starting to show~     that the bulk of these heart complications happen in patients thought to have low risk~     factors not yet identified, including ISH.~      The investigators believe that the oxygen supply to the heart can be compromised around the~     time of surgery in ISH patients Chemicals known as stress hormones are secreted around the~     time of surgery, increasing oxygen needs in the heart and may make the oxygen supply to the~     heart muscle critical (know as myocardial ischemia). This in turn may result in a heart~     attack and death. Studies have shown that patients with myocardial ischemia stand a 9-fold~     increase in odds ratio of suffering a heart attack, worsening of angina, or death.~      This study aims to compare the incidence of myocardial ischemia in patients with ISH and~     normal BP patients around the time of surgery using a special heart monitor. In addition,~     the study aims to determine the prevalence of ISH among surgical patients and to document~     complications like heart attacks, heart failure, stroke and death after surgery.~      This research project will be conducted at the Ottawa Hospital by a multi-disciplinary~     research group (perioperative research group)which includes anesthesiology, cardiology,~     general surgery and epidemiology. The research group secured HSFO funding for this study.~   "
138834|NCT01237639|"~     Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem~     cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow~     disorders. This involves the use of high doses of chemotherapy and/or radiation to kill~     cancer cells; but this damages the marrow and blood system. Blood stem cells are~     transplanted by infusing into the recipient and blood counts recover over 2-3 weeks. Before~     bone marrow recovery, RBCs are needed to support the patient. Higher hemoglobin in these~     high risk patients may have benefits such as better energy and organ function. However,~     research in other areas of medicine suggests that a higher red cell count may be dangerous.~     Taken together, it is unclear whether having a lower or higher red cell count is better for~     patients having a blood stem cell transplant. The investigators plan to study this by~     randomly assigning patients having a transplant to be transfused with RBCs either at a~     higher or lower hemoglobin level. In this way, the investigators will be able to accurately~     find out if there are any benefits or harms in having a lower or higher red cell count~     during the recovery period after blood stem cell transplantation.~   "
138835|NCT01237626|"~     The following study is designed in order to effectively collaborate and coordinate~     information amongst colleagues to advance knowledge on information related to older drivers.~     Candrive is dedicated to improving the safety and quality of life of older drivers. The~     major objective is to develop a valid, easy to use in office screening tool that will help~     clinicians identify older drivers who need further assessment of their driving. Over the~     course of the study, the goal will be to provide enough data to establish findings relating~     to knowledge generation, translation of research into action, training and sustainability.~     It is our hope that the research process will translate to help increase the knowledge of~     public policy makers, clinicians and the general public. A 5 year study will create an~     opportunity to document the natural course of an older adult's driving patterns up until~     driving cessation. This will not only provide data for road safety but also help understand~     the psychosocial factors leading to driving cessation. The data relating to psychosocial~     factors may also lead the way in establishing ways of extending the safe driving period for~     older adults.~      The investigators hypothesize that the knowledge derived from this interdisciplinary~     research will be used by transportation policy makers, clinicians, and general public to~     improve safety and quality of life for older drivers.~   "
138836|NCT01237613|"~     The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue~     Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with~     regard to lower leg and foot function, pain and quality of life.~   "
138837|NCT01237600|"~     The purpose of this study is to elucidate the appropriate condition of developing cultivated~     corneal epithelial graft and evaluate the surgical outcome of transplantation of the~     cultivated corneal epithelial stem cell in the patients.~   "
138838|NCT01237587|"~     The purpose of this study is to determine whether duloxetine is safe and effective in the~     treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).~      This trial consists of two distinct study periods. A blinded treatment period of 13 weeks~     and an open label extension period of 26 weeks.~   "
138839|NCT01237574|"~     Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France.~     The long-term prognosis of these two diseases are not well known because main studies are~     retrospective and with only alcoholic patients. The knowledge of the natural history of~     these diseases should improve the management of patients with such diseases.~      The aim of this prospective cohort is to describe the natural history of patients with~     chronic liver disease due to alcohol or metabolic disease and to identify factors associated~     with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites.~     ..).~   "
138840|NCT01237561|"~     This project will evaluate the translation of the Gold (the Global Strategy for the~     Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD~     guidelines into primary care practice. During phase I, a needs assessment will evaluate~     barriers and facilitators to implementation of COPD guidelines into clinical practice~     through focus groups of primary care patients and providers. Using formative evaluation and~     feedback from the focus groups, three tools will be developed, refined and pilot tested. The~     effectiveness of the materials developed in phase I will be tested in phase II (a randomized~     clinical trial conducted with one year of intervention within non-academic primary care~     practices) regarding physician performance of COPD guideline implementation and improvement~     in the clinically relevant outcomes (appropriate screening, diagnosis and management of~     COPD) compared to usual care.~   "
138841|NCT01237548|"~     Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath~     condensate (EBC) and pulmonary function tests in healthy volunteers.~      Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial~     Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy~     volunteers.~      Design: Prospective study evaluating these parameters before and after 30 minutes of~     Narghile smoking. The changes in inflammatory parameters pre and post smoking will be~     evaluated blindly.~      Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile .~     Intervention: Each subject will undergo evaluation including a respiratory questionnaire,~     endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and~     carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession~     of 30 minutes narghile smoking.~   "
138842|NCT01237535|"~     This is a single center, 3 arms, prospective randomized controlled open study to determine~     the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles~     with recombinant FSH in patients with unexplained infertility and mild male factor.~      Patients will be randomized into 3 groups:~        1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8%~          vaginal gel; Serono, Israel)~        2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel)~          and Estrofem 4mg].~        3. No luteal support~   "
138843|NCT01237522|"~     The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians~     volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that~     renal clearance of metformin is affected in Caucasian with the known single nucleotide~     polymorphisms A270S in OCT2.~   "
138844|NCT01237509|"~     Hypoglycaemia is associated with characteristic changes in the EEG with the appearance of~     slow frequency waves. In a recent study the investigators have shown that these changes can~     be recorded from subcutaneous electrodes and processed by an automated mathematical~     algorithm based on non-linear spectral analysis, and that changes are present before the~     occurrence of severe hypoglycaemia in type 1 diabetes patients. An alarm device based on~     real-time analysis of continuous EEG-recordings may thus be possible. For many diabetes~     patients nocturnal hypoglycaemia is a feared complication which may thus be preventable.~   "
138845|NCT01237496|"~     This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis~     B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized~     in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample~     collection period for each patients will occur in the first 24 weeks.~   "
138846|NCT01237483|"~     The purpose of this study is to investigate in patients with cancer of the throat and~     recurrent inoperable a different modality treatment consisting of radiation continuously for~     5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer,~     called Erbitux ®.~      The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment)~     to improve the antitumor efficacy without additional toxic side effects.~   "
138847|NCT01237470|"~     Contemporary treatment of inguinal hernia is generally based on surgical methods with the~     use of synthetic meshes. The implanted meshes however have some disadvantages: they increase~     the risk of infection, tend to sustain inflammation process, can generate chronic pain and~     fertility disorders, can move from the initial implantation site, increase costs of~     treatment etc. The research to find any new hernioplasty without the use of meshes is still~     going on.~      Desarda in 2002 year published his own results over hernia treatment with the use of~     external oblique aponeurosis. These results were comparable with the effects of Lichtenstein~     technique.~      The initial assessment done in our own department revealed good clinical results after~     hernia treatment with Desarda's method.~      To make appropriate and objective clinical assessment of the Desarda's technique for primary~     inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was~     projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in~     the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.~      Generally no statistically significant differences were found between these groups. The only~     difference was higher rate of seroma after Lichtenstein technique and different pain~     perception in both groups. To the summary it is clear that Desarda technique is quite~     attractive and good proposition for operative hernia treatment without mesh. The RCT was~     done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for~     clinical trials.~   "
138848|NCT01237457|"~     This is a phase II treatment protocol offering 177Lu-DOTATATE therapy for somatostatin~     receptor expressing cancers including, but not limited to, those arising from the neural~     crest and involving such organs as the lungs, breast, gastrointestinal tract, skin and~     endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non radioiodine~     avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small~     cell lung, Carcinoid and pancreatic islet cell malignancies).~   "
138850|NCT01237431|"~     In patients with autonomic dysfunction water drinking elicits a pressor response mediated by~     sympathetic activation. If any, in healthy subjects there is only a slight increase in blood~     pressure. However, the sympathetic activation is observable by resting energy expenditure~     increases greater than 20%.~      The investigators believe that the response to water may be mediated through sympathetic~     activation elicited by osmosensitve spinal afferents in the liver. Therefore, the~     investigators want to test water in liver transplant patients who have a denervated liver.~     Kidney transplant patients serve as control subjects. The investigators hypothesize that the~     increase in norepinephrine after water drinking is blunted in liver transplant recipients.~   "
138851|NCT01237418|"~     The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited~     prospectively over a period of 2 months.~      Patients will be followed up at 1 month and then followed annually for 10 years.~      Patients should have agreed to participate in the study, participation in the protocol, or~     refusal to participate will not affect the therapeutic approach of the physician. The study~     of genotypic or phenotypic characteristics will not change the therapeutic approach of~     health care teams.~   "
138852|NCT01237405|"~     The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear~     Medicine imaging technology that enables localization of activated macrophages in the joints~     of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic~     unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows:~     knee radiography, FolateScan of the knees and whole body, musculoskeletal exam,~     questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory~     markers. Data analysis will be cross-sectional and include a comparison of the location and~     intensity of EC20 uptake with the following: radiographic knee OA severity, clinical~     measures of disease severity, cytokine expression, and synovial fluid cell count.~   "
138853|NCT01237392|"~     A single center, randomized, parallel, clinical outcome trial to compare the rate of healing~     in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation)~     or standard of care sharp debridement.~   "
138854|NCT01237379|"~     The purpose of this study is to screen for peroxisome defects in child and adolescent~     offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning~     to mania and following the onset of mania.~      Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic~     patients will exhibit graded deficits in measures of peroxisomal function compared with~     healthy controls.~      Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells~     Docosahexaenoic acid (DHA) composition.~      Prediction 3: Graded deficits in measures of peroxisomal function will be inversely~     correlated with manic and depression symptom severity scores.~   "
138855|NCT01237366|"~     This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a~     multi-component intervention to address traumatic stress symptoms among HIV-positive,~     methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56~     participants will be randomized to receive either: 1) a 7-session intervention to address~     traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control~     condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.~   "
138856|NCT01237353|"~     In this study the investigators will test a nutritional supplement called betaine~     hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers~     who have decreased stomach acid because they take a medicine called rabeprazole.~   "
138857|NCT01237340|"~     To assess the immunogenicity of Saizen® solution for injection in adult subjects with~     documented Growth Hormone Deficiency (GHD).~   "
138858|NCT01237327|"~     Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women~     with natural or induced postmenopausal status with advanced breast cancer whose disease has~     progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had~     participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.~   "
138859|NCT01237314|"~     This study will record the impact of food on blood glucose levels using continuous glucose~     monitoring (CGM).~      The investigators think the impact will improve as medication doses are adjusted. The~     investigators also think that the impact will differ depending on the type of medication~     taken.~   "
138860|NCT01237301|"~     The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions~     related to the management of type 2 diabetes. The secondary objective is to determine the~     benefit of using CGM for clinical diabetes management decision-making.~   "
138861|NCT01237288|"~     The purpose of this study is to investigate the efficacy and safety of oral phosphate~     (Z-521) in subjects with primary hypophosphatemic rickets.~   "
138862|NCT01237275|"~     First, the investigators examined the functional relevance of serotonin transporter~     polymorphisms by quantifying the activity of serotonin transporter in blood platelets of~     genotyped healthy volunteers and patients with major depression.~      Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and~     also to the functional expression of 5-HTT in platelets.~   "
138863|NCT01237262|"~     The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in~     many studies.~      Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in~     dendritic cell biology, both for their maturity and mobilization of peripheral tissues to~     secondary lymphoid organs.~      The primary objectives of this study are:~        -  To document absolute number, density of immune infiltrate and dendritic cells and~          inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic~          lesions vs normal skin of the same patient~        -  To describe changes in such cell numbers and expression patterns upon 16 weeks~          treatment with TNF alfa inhibitors.~   "
138886|NCT01236963|"~     It is difficult to obtain patient's compliance with regular interproximal dental hygiene.~     Dental floss is recognized as an effective procedure to remove dental plaque and prevent~     gingivitis in the space between teeth, but it is difficult to use and most patients do no do~     it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on~     gingivitis prevention. These properties may be of interest to control dental plaque~     accumulation and gingivitis in interproximal areas. The study hypothesis states that there~     are no differences between the use of an essential oils mouthrinse and dental floss on the~     reduction of dental plaque accumulation and gingivitis.~   "
138864|NCT01237249|"~     This is a national, multicenter, open-label, randomized, comparative study designed to~     compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV~     alternating with Rd) in newly diagnosed MM patients older than 65 years. This comparison~     will be performing in terms of both efficacy and safety. Up to 120 patients will be included~     in each treatment arm and evaluated at scheduled visits in up to 3 study periods:~     Pre-treatment, Treatment and Follow-up.~      Primary outcome measure:~        -  To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and~          Rd used as either in a sequential or alternating approach in newly diagnosed MM~          patients older than 65 years.~        -  To evaluate the toxicity (safety and tolerability) of the sequential versus the~          alternating use of MPV and Rd.~      Secondary outcome measure:~        -  To evaluate the response, duration of response, progression free survival (PFS), time~          to next therapy (TNT) and overall survival (OS) in the two different groups of~          patients.~        -  To identify, within the group of patients treated with the alternating scheme, the~          biological characteristics (including a comprehensive genomic analysis) of those~          patients resistant to one or the other, and patients refractory to both treatments~   "
138865|NCT01237236|"~     LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.~     CDK4/6 is involved in the process that allows both normal and cancer cells to divide and~     multiply. Cancer cells are often driven to divide and multiply by abnormalities that~     increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may~     slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different~     tumor models in animals.~      Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease~     the ability of the bone marrow to make white blood cells, platelets, and red blood cells.~     Although these effects are expected to be reversible, they can increase the risk of~     infection, bleeding and fatigue.~      The primary purpose of this study is to find the highest dose of LEE011 that can be safely~     given to adult patients with advanced solid tumors or lymphomas for which no further~     effective standard treatment is available. It will provide information about the side~     effects that may occur following treatment. The study will also possibly provide early~     evidence for LEE011's anti-tumor activity.~   "
138866|NCT01237223|"~     The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and~     safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with~     essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110~     mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted~     to support registration of the fixed-dose combination of aliskiren and amlodipine for the~     treatment of hypertension in Japan.~   "
138867|NCT01237210|"~     This study is looking for healthy controls and patients with Parkinson's (PD) to perform an~     MR scan.~        1. The neurochemical profile of the SN of patients with PD as measured by high field MRS~          will differ from that of healthy controls, in that glutathione will be lower due to~          oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis~          markers myo-inositol and glutamine will be higher due to inflammation (glial~          activation) and N-acetylaspartate and glutamate will be lower due to neuronal~          loss/damage.~        2. There will be a relationship between neurochemical changes and disease severity.~   "
138868|NCT01237197|"~     Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated~     with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM).~     Obesity tracks strongly into adulthood and interventions early in life may reduce risk for~     developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss~     have been evaluated in adolescents. Since exenatide is associated with weight loss and~     improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be~     useful in extremely obese youth. Our primary objective in this study is to generate~     preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve~     risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese~     adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled~     pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric~     obesity and is an innovative approach to a challenging and significant health care problem.~   "
138869|NCT01237184|"~     The primary purpose of this study is to~        1. determine whether dental implant engaging both the alveolar crest cortical bone and~          sinus floor using vertical stopper drill and self-threading concept (bi-cortical~          fixation) increases initial implant stability compared to the short implants engaging~          only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both~          crest and sinus floor but with green stick fracture (indirect sinus lift technique),~        2. study whether different surgical techniques, residual bone height, bone density, and~          length and width of the implants used affect initial implant stability in posterior~          maxilla. In addition, this study will continue to~        3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and~          with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year~          follow-up from the restoration and~        4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer~          tomogram) scan and evaluate safety and potential post-operative complications of~          bi-cortical fixation and indirect sinus lift technique reported throughout the follow~          up periods.~   "
138870|NCT01237171|"~     For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is~     usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of~     lung may leave too little lung behind for easy breathing. For some of these patients, it may~     be possible to perform a smaller-scale surgery (sub-lobar resection) and place a~     radioactive implant behind to prevent the cancer from growing back. This study will see how~     these patients do in terms of controlling their disease treated with a radioactive implant~     called Cesium-131.~   "
138887|NCT01236950|"~     The use of mouthrinses may be of relevance as a complement to daily dental hygiene~     procedures, especially for patients who do not comply with a proper mechanical removal of~     dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental~     plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The~     study hypothesis states that there are no differences between the mouthrinses on the~     reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of~     Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.~   "
138871|NCT01237158|"~     Background: The pathophysiological mechanisms of bipolar disorder are not completely~     clarified and several hypothesis have already been formulated including the role of~     monoamines, gama amino butyric acid (GABA) and glutamate. GABA is the main inhibitory~     neurotransmitter while glutamate is the main excitatory neurotransmitter. Genes that play a~     role in GABA metabolism and in the activity of GABA neurons are very important to understand~     the GABA function, once they affect neurodevelopment and its dysfunctions may predispose to~     neuropsychiatric diseases. The two genes that are going to be study in this project are~     glutamic acid decarboxylase (GAD1) and reelin (Reln). The enzyme glutamic acid~     descarboxylase (GAD67) metabolizes glutamate in GABA in the pre synaptic neuronal regions~     and is coded by the gene GAD1. Reelin is secretory serine protease with dual roles in~     mammalian brain: embryologically, it guides neurons and radial glial cells to their~     corrected positions in the developing brain; in adult brain, Reelin is involved in a~     signaling pathway which underlies neurotransmission, memory formation and synaptic~     plasticity. Magnetic resonance spectroscopy (MRS) studies on bipolar disorder show a number~     of alterations in cerebral level of GABA and glutamate in different cerebral areas when~     compared to healthy subjects and other mood disorders. Objective: Investigate in bipolar~     patients and healthy controls the association of GAD1 and Reln single nucleotide~     polymorphisms(SNP) and cerebral levels of GABA/glutamate on MRS. Methods: 70 symptomatic~     bipolar I patients medication free and 70 healthy controls are going to be genotyped for~     GAD1 and Reln SNPs and GABA/glutamate MRS.~      Key words: GAD1, GAD67, bipolar, GABA, Glutamate, Reelin, Rln, Spectroscopy.~   "
138872|NCT01237145|"~     The purpose of this study is to establish if cells present in lung tissue during extrinsic~     allergic alveolitis (EAA) are able to elicit an immune response against specific antigens.~     The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to~     specific antigens and this response can be measured using ELISPOT.~   "
138873|NCT01237132|"~     The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and~     European Associations for the Study of Liver Disease are based on the~     Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in~     patients with large, multinodular and macrovascular invasive disease. The aim of this study~     was to investigate the role of hepatic resection in a large retrospective multicentric~     cohort of patients resected for HCC regardless of the BCLC indications.~   "
138874|NCT01237119|"~     The purpose of this study is to investigate whether 48 weeks treatment with once-daily~     injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and~     related metabolic parameters in overweight patients with nonalcoholic steatohepatitis,~     enough to warrant further investigation.~   "
138875|NCT01237106|"~     This pilot study will be a prospective investigation to study the efficacy and safety of~     In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be~     10 subjects total in this Study. There will be no blinding to treatment.~      In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting~     pregnancy through the use of Assisted Reproductive Technology (ART).~   "
138876|NCT01237093|"~     Background:~      - Researchers who study health and nutrition are interested in developing more accurate~     methods of determining what people eat from day to day and how it affects their general~     health. In particular, better methods are needed to determine if people are accurately~     remembering what they ate. One possible method involves the use of biomarkers, or indicators~     in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food~     in a consistent way. One set of biomarkers in blood samples and hair may be used to~     determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet.~     However, more research is needed to study the effectiveness of using these biomarkers to~     accurately track dietary intake.~      Objectives:~      - To validate the use of biomarkers as representative of specific dietary intake patterns~     (meat/fish/soda).~      Eligibility:~      - Healthy, nondiabetic men between 18 and 65 years of age.~      Design:~        -  This study involves an initial screening visit and a 12-13 week inpatient dietary study~          period.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood and urine samples and a glucose tolerance test to exclude individuals who have~          diabetes.~        -  After 3 days of a standard weight-maintaining diet, participants will have a glucose~          tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and~          complete questionnaires and performance tests.~        -  Participants will spend one day in a metabolic chamber to measure their energy~          expenditure and general metabolism.~        -  Participants will then be randomized into one of eight carefully designed diets for 12~          weeks. The diets will differ in the amount of meat, fish, and soda, including one diet~          where none of the three biomarker-related foods will be permitted. Blood samples will~          be collected throughout the study diet period.~        -  At the end of the 12-week study diet period, participants will provide additional hair,~          blood, and fat tissue samples, and will have a second metabolism assessment in the~          metabolic chamber.~   "
138877|NCT01237080|"~     The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation~     of morbidly obese. Mainly we will try to clarify which of the instruments that produce the~     shortest intubationtime and lowest number of intubationattempts.~      The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of~     attempts, using the GlideScope®.~   "
138878|NCT01237067|"~     Background:~      - Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP~     inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also~     encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in~     combination with carboplatin, a drug used to treat breast, ovarian, uterine, and cervical~     cancer, but more research is needed to determine whether the drugs are more effective when~     given together or which drug should be given first.~      Objectives:~      - To determine the safety and effectiveness of combined carboplatin and olaparib as a~     treatment for gynecologic (female organ) or breast cancer.~      Eligibility:~        -  Women at least 18 years of age who have breast, ovarian, uterine, or cervical cancer~          that has not responded to standard treatments.~        -  Men at least 18 years of age who have metastatic breast cancer and have a BRCA-1/2~          mutation.~      Design:~        -  Participants will be screened with a physical examination and medical history, as well~          as blood and tumor samples and imaging studies as required by the researchers. Study~          participants will then be divided into two groups.~        -  Group 1: Participants will receive olaparib tablets twice a day for 7 days (14 doses)~          and will receive carboplatin by vein on day 1 or 2, for a 21-day treatment cycle. Group~          1 study is designed to determine the safety of new tablet formulation of olaparib.~        -  Group 2: Participants will be divided into two smaller groups, with reversed treatment~          schedules. Group 2 study is designed to evaluate which drug should be given first~          through endpoint studies in blood samples.~        -  Group 2A: Participants will receive olaparib tablets twice a day for 7 days (14 doses)~          and then carboplatin on day 8 of the first cycle. Cycle 2 will start with carboplatin~          on day 1 and olaparib starting on day 2 for 7 days (14 doses).~        -  Group 2B: Participants will receive carboplatin on the first day of the first cycle,~          and then olaparib on day 2, twice a day for 7 days (14 doses) of the first cycle. Cycle~          2 will start with 7 days of olaparib (14 doses) and carboplatin will be given on day 8.~        -  From cycle 3 until completion of therapy, all Group 2 participants will follow the~          schedule used for Group 1 (carboplatin on day 1 or 2 of the week of olaparib therapy,~          also in 21-day cycles).~        -  Additional blood and tissue samples and imaging studies will be conducted throughout~          the treatment period.~        -  All participants may receive no more than 8 cycles of olaparib and carboplatin therapy,~          but may continue to take olaparib if their cancer responds to the treatment.~   "
138888|NCT01236937|"~     The primary outcome of this study is to investigate the accuracy of respiration gated laser~     guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based~     breath hold monitoring system. Secondary outcome is the rate of complications using laser~     guided CT biopsy in general and with bellows-based breath hold monitoring system. The study~     has approval from the The Danish National Committee on Biomedical Research Ethics (ref no:~     H-4-2010-fsp 1).~   "
139158|NCT01233388|"~     The aim of this proposal is to pioneer the implementation and evaluation of a novel patient~     centered text messaging vaccine adverse event surveillance network.~   "
138879|NCT01237054|"~     Background:~      - Recent studies have shown that the premalignant conditions monoclonal gammopathy of~     undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of~     progressing to multiple myeloma (MM). There are currently no known effective treatments to~     prevent MGUS or SMM from developing into MM, and there are no known tests for determining~     whether an individual with MGUS or SMM will develop MM. Researchers are investigating new~     and improved imaging techniques that may be able to better detect the progression of MGUS or~     SMM into MM.~      Objectives:~        -  To compare the results of three imaging techniques in individuals with MGUS, SMM, and~          MM.~        -  To correlate the information from the imaging studies with established clinical markers~          of progression from MGUS/SMM to MM.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of~     undetermined significance, smoldering multiple myeloma, or multiple myeloma.~      Design:~        -  Participants will be screened with a physical examination and medical history, and will~          provide baseline blood, urine, and bone marrow samples before beginning the imaging~          studies.~        -  Participants will have three imaging studies on separate days: a standard~          18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG~          PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),~          and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).~        -  Participants will be closely monitored during each scan, and will provide additional~          blood samples before and after the scans.~        -  Participants may provide additional blood, urine, tissue, and bone marrow samples for~          optional research studies.~   "
138880|NCT01237041|"~     Background:~      - Overweight and obese children and adults often have lower levels of growth hormone in the~     blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood.~     Current tests of growth hormone (such as those used when evaluating the heights of children~     who are markedly shorter than other children of comparable age) may be affected by other~     factors, including obesity. Researchers are interested in evaluating the levels of growth~     hormone and free fatty acids in the blood of children between 7 and 14 years of age who~     weigh more than children of a comparable age, or who are shorter than other children of a~     comparable age and have been recommended for growth hormone testing as part of an evaluation~     for their height.~      Objectives:~      - To determine the effect of changes in free fatty acids in the blood on changes in growth~     hormone secretion in overweight or shorter children and young adolescents.~      Eligibility:~      - Children and adolescents between 7 and 14 years of age who weigh more than or are shorter~     than other children of a comparable age and do not have any medical illnesses.~      Design:~        -  Participants will have two study visits, one of which will be a half day screening~          visit in the outpatient clinic and one of which will require 2 nights as an inpatient~          at the National Institutes of Health Clinical Center.~        -  Participants should not eat or drink anything except water after 10 PM the night before~          or on the morning of the screening visit.~        -  At the screening visit, participants will have a physical examination and medical~          history, provide blood and urine samples, have an oral glucose tolerance test (to check~          blood sugar levels), and have an x-ray of the left hand to check bone age.~        -  The inpatient study visit will involve a physical examination and medical history, a~          full x-ray scan to study body fat and muscle, frequent blood tests throughout the~          visit, and various medications to stimulate growth hormone production and lower levels~          of free fatty acids in the blood.~   "
138881|NCT01237028|"~     This study will help to show the efficacy of vitamin D and address the optimal strategy to~     minimize renal injury in IgAN patients.~   "
138882|NCT01237015|"~     Current knowledge suggests that, to be successful, oral feeding in preterm babies should be~     initiated as soon as possible, often at an age where immature respiration still requires~     ventilatory support in the form of continuous positive airway pressure (CPAP). While some~     neonatologist teams claim great success with initiation of oral feeding in immature babies~     with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at~     oral feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive~     sucking and swallowing, including their coordination with breathing, and the fear to induce~     deleterious problems such as pulmonary aspiration of milk and/or respiratory failure.~     Ensuing delay in becoming proficient with oral feeding unduly prolongs hospital stays of~     preterm babies.~      The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human~     neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on~     breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize~     that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing~     coordination and will not induce deleterious cardiorespiratory events.~      Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one~     with nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity,~     respiration, heart rate and oxygenation will be continuously recorded before, during and~     after bottle-feeding.~      By filling a gap in knowledge, results from the study will hopefully help neonatologists~     afraid of doing more harm than good when initiating bottle-feeding in preterm babies under~     CPAP to join the many teams for whom it is no more a problem.~   "
138883|NCT01237002|"~     Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy,~     without an established time-limit. However, many authors claims its danger for patients'~     outcome. The investigators check the short term outcome of a consecutive cohort of patients~     who underwent hepatectomy with intermittent clamping exceeding 120 minutes.~   "
138884|NCT01236989|"~     Prognostic impact of AR vs NAR~   "
138885|NCT01236976|"~     The study is a multi-centre, assessor-blind, randomised controlled phase III trial in~     patients with with complete or incomplete spinal cord injury between C6 and T12. A total of~     188 participants will be randomised into two groups, the experimental group and the control~     group. The control group participants will receive an upper body strength and fitness~     program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental~     group participants will receive a comprehensive full body exercise program, conducted for~     2-3 hours, three times per week for 12 weeks.~      The main objective of this study is to determine if the experimental exercise program is~     more effective than the upper body strength and fitness program in promoting neurological~     improvement in participants with spinal cord injury.~      Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week~     treatment period followed by 6 month and 12 month (from baseline) follow up assessments.~      Participants will be assessed by a blinded assessor (the assessor will not know which group~     the participants are in) using standard physiotherapy, neurophysiological, fitness and~     functional tests, psychological and quality of life questionnaires, as well as tests of~     immune function and bone structure.~   "
138889|NCT01236924|"~     Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus~     pulposus in intervertebral spaces, which may cause compression of nerve structures. It is~     estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8%~     in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the~     effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic~     lumbar disc herniation with the application of a randomized controlled trial. Will be~     measured pain, disability and functional flexibility.~   "
138891|NCT01236898|"~     The aim of this study is to investigate pharmacokinetics and safety of N-acetylneuraminic~     acid in patients with Distal myopathy with rimmed vacuoles (DMRV) - hereditary inclusion~     body myopathy (hIBM). Dosages are 800mg single and three times a day and 800mg 3 times a day~     for 5 consecutive days. N-acetylneuraminic acid and N-glycolylneuraminic acid in serum and~     urine are measured before and after oral administration of N-acetylneuraminic acid.~   "
138892|NCT01236885|"~     This clinical trial studies computer-guided glucose management systems in treating patients~     with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided~     glucose management system may help manage glucose levels in patients who have undergone~     blood or bone marrow transplant.~   "
138893|NCT01236872|"~     Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric~     oxide is normally produced by the inner lining of blood vessels and helps keep blood vessels~     open and therefore blood pressure lower. In subjects with high blood pressure, the inner~     lining of the blood vessels does not function adequately. The investigators wish to~     investigate whether elevating systemic levels of inorganic nitrate (through provision of~     dietary nitrate-rich vegetables) can elevate levels of nitrate/nitrite in hypertensive~     subjects, and whether this has a beneficial effect on blood pressure.~   "
138894|NCT01236859|"~     Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after~     administration. Pruritus is the most common side effect of intrathecal morphine, which the~     incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of~     opioid-induced pruritus remain unclear and more than one mechanism may be involved in the~     development of opioid-induced pruritus, such as, mediated central µ opioid receptors,~     Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors,~     and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many~     medications have been used to treat this side effect included antihistamines, 5-HT3~     (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol,~     and nonsteroidal antiinflammatory drugs.~      Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently~     approved by the Food and Drug Administration for the treatment of partial seizures and~     postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of~     brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple~     sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of~     unknown origin. However, there is only one small study in Taiwan shown the effectiveness of~     gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic~     surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction).~     Because gabapentin has several side effects especially in high dose such as drowsiness, dry~     mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation,~     diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and~     nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we~     would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age~     including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in~     orthopedic surgery in Songklanagarind Hospital.~   "
138895|NCT01236846|"~     Study is a 12-week Double blind,controlled experiments designed to examine the possible~     effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and~     oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink~     intake.~   "
138896|NCT01236833|"~     The objective of this study is determining if enteral administration of Lactated Ringer's~     solution (LR) in preterm infants with feeding intolerance enables for faster advancement of~     milk feeding than fasting.~   "
138897|NCT01236820|"~     The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins,~     is an effective predicting factor for cardiovascular disease in chronic renal and~     hemodialytic patients.~   "
138898|NCT01236807|"~     The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to~     coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management~     of patients with stable chest pain.~        -  All patients will undergo an MR Perfusion Imaging test.~        -  Further management will be guided by the result of the cardiac MRI in half of the~          patients (chosen by random).~        -  The other half will undergo coronary angiography with measurement of FFR. The result of~          this test alone will guide their further management. The result of the initial MR~          Perfusion test will not be available to the treating doctors of this group.~        -  All patients will receive optimal medical therapy (OMT)~        -  All patients will undergo follow-up to find out if they have any relevant heart related~          events.~   "
138899|NCT01236794|"~     The purpose of this study is to examine the effects of a lifestyle intervention program on~     type 2 diabetes risk factors and quality of life in overweight Latino youth.~   "
138900|NCT01236781|"~     This multicenter trial using Hologic digital mammography units will evaluate the specificity~     of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D~     tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be~     measured by the participant call-back rate by each modality. Varying combinations of 2-D~     mammography and tomosynthesis projections will be evaluated to optimize the screening~     paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective~     and retrospective imaging data will be assessed.~      Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer~     screening as measured by a reduction in the call-back rate while maintaining the sensitivity~     of cancer detection. This improved accuracy will be achieved by the optimization of the~     imaging sequence and number of views obtained at a capped radiation dose in the combined DBT~     and 2-D screening sequence.~   "
138901|NCT01236768|"~     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal~     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.~   "
138902|NCT01236755|"~     This study aims at investigating the efficacy of myopic control using ortho-k in younger and~     older children.~   "
138903|NCT01236742|"~     The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects~     who stop the treatment with subjects who continue ortho-k lens wear and control subjects~     wearing single-vision glasses.~   "
138904|NCT01236729|"~     Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and~     improves quality of life. There is, however, limited data concerning its results in older~     people and on its effect on how patients survive in regular activities of daily living~     (ADL), such as bathing and shopping. In this study, the results of knee replacement are~     evaluated from the point of view of disability in everyday activities and self-rated health.~     Moreover, association with ADL performance and clinical knee scores and severity of~     osteoarthritis are assessed.~   "
138905|NCT01236716|"~     This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in~     advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and~     some biomarkers is also to be evaluated.~   "
138906|NCT01236703|"~     CRP and PCT are not valid parameters of early infection in particularly postoperative~     patients. (Sanders et al., A&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol~     15.2) Better detection systems for SIRS and sepsis are urgently required.~      ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic~     score) are two new score-systems depending on detectable cellular response of the innate~     immune system in human peripheral blood.~      The purpose of this observational study is to determine if these scores are superior in~     early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in~     postoperative patients. Furthermore, the applicability of the scores for triggering start~     and ending of anti-infective therapy will be examined.~   "
138907|NCT01236690|"~     Cinobufacini has the effects of anticancer, improving the liver function, elevation of~     immunity and little side effects, and is important and significant for the patients with~     hepatitis, liver cirrhosis and hepatomas.~      Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini~     is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .~   "
138908|NCT01236677|"~     In the 21st century, threats to human health of new respiratory infectious diseases~     increased.~      The project aim is to establish pneumonia pathogens network in Beijing and understand the~     pathogen spectrum distribution.~   "
138909|NCT01236664|"~     With the aging of the Canadian population, older workers are accounting for more and more of~     the working-age population. Despite recent interest in cognitive training, there are~     currently no validated programs that specifically target individuals in the work force. The~     investigators will conduct a small-scale randomized controlled trial to test the~     effectiveness of the previously developed Memory at Work program. The investigators will~     recruit 60 individuals and randomly assign them to the active intervention or a control~     intervention. The investigators will examine outcomes related to knowledge, behavioral~     change, self-efficacy, objective memory, and workplace productivity. The investigators~     expect larger improvements on these measures in the active relative to the control group.~   "
138910|NCT01236651|"~     Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the~     First Stage of Labor in Full Term Primigravidae~   "
138911|NCT01236638|"~     This extension protocol to the core study CCL09101 allows patients who have tolerated the~     drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of~     the core protocol. Long term safety and efficacy of CYT387 will be evaluated.~   "
138912|NCT01236625|"~     Official title:~      LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or~     laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs~      Background:~      With improved surgical technology and ageing of the population the number of reoperations in~     the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a~     high as 30% in the first ten years after a laparotomy. In over 95% of reoperations~     adhesiolysis is required to gain access to the abdominal cavity and operation area.~     Adhesiolysis significantly increases the risk for inadvertent organ damage, such as~     enterotomies, leading to higher morbidity, mortality and socioeconomic costs.~      Purpose:~      To define the impact of adhesiolysis on per- and postoperative complications, quality of~     life and socioeconomic costs.~      Design:~      Prospective observational study.~      Primary outcomes:~        -  adhesiolysis time~        -  inadvertent enterotomy~        -  seromuscular injury~        -  miscellaneous organ damage~        -  Serious adverse events of operation (anastomotic leakage, delayed diagnosed~          perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary~          tract infection, abscess, fistula, sepsis, death)~      Secondary outcomes:~        -  Hospital stay~        -  Intensive care admission~        -  Reinterventions~        -  In-hospital costs~        -  Parenteral feeding~        -  Short term readmissions (30 days)~        -  Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke~          Activity Score Index(DASI) )~      Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010~     Estimated study completion date: 1 february 2011~   "
138913|NCT01236612|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life significantly contributing to the ongoing poverty in endemic countries. It~     causes almost one million deaths per year, the majority of which are children under the age~     of five. The malaria parasite enters the human body through the skin, by the bite of an~     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the~     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the~     blood stream, causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct experimental human malaria infections~     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although~     potentially serious or even lethal, Plasmodium falciparum (P.falciparum) malaria can be~     radically cured at the earliest stages of blood infection where risks of complications are~     virtually absent.~      The investigators have shown previously, that healthy human volunteers can be protected from~     a malaria mosquito challenge by immunization with mosquito-bites under chloroquine~     prophylaxis (CPS immunization). However, it is unknown whether this protection is based on~     immunity directed towards the liver- or the blood stage of the disease. For future~     development of vaccines and understanding of protective immunity to malaria, it is important~     to investigate at which level protective immunity is generated by CPS immunization.~     Therefore, we aim to investigate whether CPS immunization confers protection to a~     blood-stage challenge.~   "
138914|NCT01236599|"~     The purpose of this study is to compare the response of temperature adaptation in preterm~     infant using the polyethylene wrap with and without previous drying.~   "
138927|NCT01236430|"~     The intent of this study is to demonstrate that single doses of the Final Market Image (FMI)~     ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are~     bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are~     coadministered as individual tablets in healthy adults.~   "
138928|NCT01236417|"~     This is a pilot study of a specifically designed exercise intervention developed for breast~     cancer patients with aromatase-inhibitor related joint pain.~   "
139159|NCT01233375|"~     The purpose of this study is to determine whether CO-1.01 is safe and effective for treating~     metastatic pancreatic cancer that did not respond to gemcitabine.~   "
138915|NCT01236586|"~     Background:~      - The anti-cancer drug RO4929097 is being tested for its ability to block blood vessel~     growth to tumors and slow or stop the growth of cancer cells. However, it has been used in~     only a small number of adults and has not yet been tested in children. Researchers are~     interested in determining whether RO4929097 is a safe and effective treatment for tumors or~     leukemia that has not responded to standard treatment.~      Objectives:~      - To determine the safety and effectiveness of RO4929097 as a treatment for children and~     adolescents who have been diagnosed with certain kinds of cancer that have not responded to~     standard treatment.~      Eligibility:~      - Children, adolescents, and young adults between 1 and 21 years of age who have been~     diagnosed with solid, nervous system, or blood-based cancers that have not responded to~     standard treatment.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies. Some participants may also have a bone marrow biopsy~          to evaluate the state of their disease.~        -  Participants will be separated into three groups: One group will receive RO4929097~          alone, and the other two will receive RO4929097 in combination with the~          immune-suppressing drug dexamethasone.~        -  RO4929097 will be given as tablets on one of two schedules: days 1 to 3 of every week~          (Schedule A) or days 1 to 5 of every week (Schedule B). The dosing schedule will be~          determined randomly. Every 4-week treatment period is one cycle, and participants may~          receive RO4929097 for up to 24 cycles.~        -  Participants will have frequent blood and urine tests and imaging studies to evaluate~          the progress of treatment, and will be asked to keep a diary to monitor any side~          effects.~   "
138916|NCT01236573|"~     Background:~      - One experimental treatment for certain types of cancer is cell therapy, which involves~     collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in~     large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that~     stimulates the immune system to attack and destroy the cancer cells. Because this treatment~     is experimental, researchers are interested in determining the side effects and overall~     effectiveness of cell therapy using white blood cells modified with IL-12 as a treatment for~     aggressive cancer.~      Objectives:~      - To determine the safety and effectiveness of cell therapy using IL-12 modified tumor white~     blood cells to treat metastatic melanoma.~      Eligibility:~      - Individuals greater than or equal to 18 years of age and less than or equal to age 66 who~     have been diagnosed with metastatic melanoma.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies.~        -  Cells for treatment will be collected during tumor biopsy or surgery.~        -  Prior to the start of cell therapy, participants will have imaging procedures, heart~          and lung function tests, and blood and urine tests, as well as leukapheresis to collect~          additional white blood cells.~        -  For 5 days before the cell infusion, participants will be admitted for inpatient~          chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in~          preparation for the cell therapy.~        -  Participants will receive the modified white blood cells as an infusion 1 to 4 days~          after the last dose of chemotherapy. The day after the infusion, participants will~          receive filgrastim to stimulate blood cell growth.~        -  Participants will remain as inpatients for at least 5 to 10 days to recover from the~          treatment, and will be followed regularly after the treatment to study side effects and~          general effectiveness.~        -  Participants who initially respond to treatment but have a relapse may have one~          additional treatment using the same procedure.~   "
138917|NCT01236560|"~     This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to~     see how well they work compared with each other when given together with radiation therapy~     followed by bevacizumab and temozolomide in treating young patients with newly diagnosed~     high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses~     high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is~     more effective then temozolomide or bevacizumab when given together with radiation therapy~     in treating glioma.~   "
138918|NCT01236547|"~     This randomized phase II trial studies the side effects and how well intensity-modulated~     radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in~     treating patients with anaplastic thyroid cancer. Specialized radiation therapy that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether radiation therapy and paclitaxel are more effective when given with pazopanib~     hydrochloride in treating thyroid cancer.~   "
138919|NCT01236534|"~     The purpose of the study is to assess how safe and effective the drug Lubiprostone is in~     people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation.~     Lubiprostone is approved by the FDA for the treatment of two common types of constipation in~     adults, chronic idiopathic constipation and irritable bowel syndrome.~   "
138920|NCT01236521|"~     The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized~     clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for~     chronic lower back pain. The study aims are: 1) to compare the interventions' (PHARM vs.~     BEH) effects on pain intensity, function, and other pain relevant outcomes at 6 months~     (primary end point) and 12 months (sustained effect); and 2) to compare the~     cost-effectiveness of the interventions~   "
138921|NCT01236508|"~     The investigators hypothesize that inflammation in carotid plaque is predictive of the~     extent of ischemic lesion burden on the brain and will add to risk stratification for~     individuals with carotid disease.~   "
138922|NCT01236495|"~     The purpose of the study is to evaluate the amount of total pethidine requirement during the~     48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.~   "
138923|NCT01236482|"~     In this study the investigators hypothesize that infused combinations of oxytocin and~     ergometrine will exhibit fewer cardiac and neurological side effects than equipotent~     infusion of oxytocin alone. In order to perform this study the investigators perform the~     following steps:~        1. The investigators validate a quantitative measure of uterine tone as our primary~          endpoint.~        2. The investigators use this endpoint measure in order to determine equipotential doses~          of different tocotonic drug regimens, based on the ED50 for each.~        3. Using equipontial ratios based on the ED50, the investigators compare hemodynamic and~          other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be~          measured.~   "
138924|NCT01236469|"~     The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human~     Heart Valve used in pediatric patients as an aortic valve replacement.~   "
138929|NCT01236404|"~     Primary objective:~      To evaluate the safety and tolerability of single and multiple ascending doses of PB1023~     administered as a subcutaneous (SC) injection in adult subjects with T2DM.~      Secondary objectives:~        1. To characterize the pharmacokinetic profile of PB1023 after single and multiple~          ascending doses of PB1023.~        2. To assess the pharmacodynamic response of various single and multiple doses of PB1023~          (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in~          response to a liquid Mixed Meal Tolerance Test (MMTT).~   "
138930|NCT01236391|"~     The primary objective of this study was to evaluate the efficacy of ibrutinib in~     participants with relapsed or refractory MCL.~      The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg~     daily) of PCI-32765 in this population.~   "
138931|NCT01236378|"~     Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in~     China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK)~     study to be conducted in renal allograft recipients was requested by State Food and Drug~     Administration (SFDA) to provide further guidance for clinical use.~      To minimize risk to patients, this study is designed to collect blood PK samples from renal~     allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or~     without concomitant medication(s). PK samples will be collected from these patients to~     characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This~     study will not involve any changes to the established treatment regimen for the patients who~     enroll in the study~   "
138932|NCT01236365|"~     Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due~     to chronic increase in the blood sugars and inflammation. If there is also increased in~     cholesterol, it creates a highly abnormal environment not fully corrected by improved~     control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its~     prevention and treatment, compelling in children. This grant proposal encompasses 3~     separate, yet interrelated projects addressing different aspects of CVD risk in children~     with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class~     of drugs called statins, which lower bad cholesterol in the body, in children with~     diabetes and elevated bad cholesterol. We will measure changes in concentration of blood~     inflammatory markers and for the 1st time, correlate levels of these markers with changes in~     blood sugar as measured by continuous glucose sensors, instruments that measure the blood~     sugar continuously through a small needle under the skin. Project #2: is a laboratory study~     to investigate the genetics and concentration of key molecules that participate in the~     inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in~     children with T1DM will be compared with those in healthy controls for the 1st time. Project~     #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children~     with T1DM and healthy age-matched controls. The results of these studies will likely provide~     important new data on the use of statins in children with diabetes.~   "
138933|NCT01236352|"~     The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable~     in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to~     permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to~     determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.~   "
138934|NCT01236339|"~     The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS~     Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have~     cirrhosis of the liver with portal hypertension and difficult to treat ascites.~   "
138935|NCT01236326|"~     Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people~     donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor~     nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation~     due to the many advantages it offers over open nephrectomy, including significantly shorter~     hospitalization and recovery time, and significantly improved cosmetic result related to the~     nephrectomy scar(s). More recently, a new procedure has been introduced to the field of~     laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN).~     In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used~     as the single incision site through which the entire donor nephrectomy is performed. The~     LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay,~     lessening recovery time, and improving satisfaction with the surgical scar. The~     investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized,~     controlled trial in living kidney donors. The investigators will compare operative times and~     intra-operative donor management, intra- and post-operative complications, pain scores,~     analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and~     function and survival of the transplanted kidney for the two groups of subjects: (1) the~     group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has~     the laparoendoscopic single site donor nephrectomy.~   "
138936|NCT01236313|"~     The purpose of this study is to prospectively determine the relationship between the~     dimensions of the aorta (the large artery taking off the heart) and blood pressure during~     cardiac surgery.~   "
138937|NCT01236300|"~     Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy~     (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous~     from non-mucinous cysts)~   "
138938|NCT01236287|"~     Voclosporin is an investigational medication previously studied to prevent acute rejection~     in patients who receive a kidney transplant. This study is a compassionate release program~     where subjects previously participating in the study entitled A Phase 2B, Randomized,~     Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus~     (Prograf®) in denovo Renal Transplant Patients (ISA05-01) may be eligible to continue to~     receive voclosporin despite the Phase 2B study being terminated by the sponsor. Under the~     compassionate release program, subjects previously taking voclosporin may continue to~     receive the study medication until the drug is FDA-approved and commercially available in~     the United States.~   "
138990|NCT01235598|"~     Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic~     Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials~     (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.~   "
138939|NCT01236274|"~     A number of studies have suggested an association between the use of antipsychotic agents~     and cardiovascular mortality. However, the relationship between cardiac events and the use~     of antipsychotic drugs is not clear. Patients experiencing psychoses and in need for~     antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of~     antipsychotic medication. Two studies have specifically investigated the association between~     the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as~     an outcome measure, reporting no association and a positive association respectively. This~     difference in results may be explained by the use of different measures as well as study~     designs in both studies and because of different limitations with regard to controlling for~     lifestyle and medical risk factors. This study aims to assess the relationship between the~     risk of MI and recent exposure to antipsychotic agents by using the self-controlled case~     series method with which we are able to control for fixed confounders. The results of the~     self-controlled case series method will be compared to the results of a case-control study~     using the same data to compare the estimates of both methods.~   "
138940|NCT01236261|"~     The aim of this study is to describe the epidemiology of fungal blood infections in Spain~     (with emphasis on the incidence, fungal species distribution and antifungal susceptibility).~     The study is to be performed in five big cities which represent different geographic areas:~     Barcelona, Bilbao, Madrid, Sevilla and Valencia.~   "
138941|NCT01236248|"~     The purpose of this study is to determine a computer- and family-based drug abuse prevention~     program is able to reduce drug use among early adolescent girls.~   "
138942|NCT01236235|"~     The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of~     Atazanavir-based regimens in real life setting.~   "
138943|NCT01236222|"~     The purpose of this study is to determine whether cycling to school is effective in the~     prevention of the metabolic syndrome.~   "
138944|NCT01236209|"~     The overall objective of this randomized controlled study (RCT) financed by the Norwegian~     Research Council (grant no. 182012/V50) is to establish the effectiveness of situational~     feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of~     patient-provider communication in a randomized controlled study (RCT). Thereby this project~     will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the~     intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c)~     quality of life, d) improved engagement in daily activities and e) prevented transition to~     chronic disability. We furthermore aim to 1) determine the effectiveness of providing~     regular situational feedback in enhancing self-management and, consequently 2) study the~     effectiveness of enhancing self-management in reducing pain and physical disability.~      Self-management of chronic pain is increasingly seen as an important tool in providing~     adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing~     the patient's self-management of her/his condition is thought to be effective in reducing~     pain and disability. However, sufficient empirical evidence to support this is yet~     unavailable. This may be due to the non-situational nature of many interventions studied so~     far: Patients are taught management skills in a clinical setting, and may not be able to~     successfully use these skills in daily care. Therefore, enhancing self-management of chronic~     pain, by providing immediate feedback that is directly related to patient's daily life~     (situational feedback) complementary to care-as usual, is thought to be more effective~     than conventional interventions in a clinical setting. This may even be even more effective~     when the patient receives quick response feedback using mobile communication technology,~     i.e. any place any time.~   "
138945|NCT01236196|"~     We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior~     therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain~     and randomizing them into one of two treatment conditions. The study sample was recruited~     from primary care clinics at the San Francisco VA Medical Center and affiliated VA~     community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San~     Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders~     that involved muscle strain and inflammation, trauma to nerves, and/or central nervous~     system dysfunction. Both interventions were delivered by telephone and consisted of 12~     sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks~     (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks~     (6-month follow-up). The sample size was chosen to provide greater than 80% power at a~     two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention~     procedures were based on the cognitive-behavioral model of chronic pain.~   "
138946|NCT01236183|"~     To determine number of cases need to perform in new anesthesia residents to be proficient in~     manual skills.~   "
138947|NCT01236170|"~     The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with~     SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove~     financial and other barriers to the provision of wheelchairs to all Veterans who need them,~     preliminary evidence suggests that disparities exist in the quality of wheelchairs~     prescribed to racial minorities and low income Veterans with SCI or AL. The proposed project~     will provide important information to the VA about the quality and equity of wheelchairs~     provided to Veterans with SCI or AL, and it will identify the patient and provider factors~     associated with wheelchair provision. Because Veterans with SCI and AL are considered~     special disability populations, identifying and understanding these factors is a critical~     first step to developing interventions to increase the quality and equity of wheelchairs~     provided to all disabled Veterans.~   "
138948|NCT01236157|"~     Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation~     that when supported by the Mobile Services Emergency and Intensive Care (SMUR).~      This ground of appeal underlying various pathologies especially acute coronary syndrome~     whose early care diagnostic and treatment significantly improves the prognosis.~      The recognition and management of SCA is therefore a public health issue. Myocardial~     infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and~     coronary heart disease is the leading cause of death in France.~      No studies have assessed the adequacy of regulation and management of chest pain SAMU for~     the diagnosis of SCA.~      The main objective of the research is to have a descriptive analysis of the population~     controlled by the SAMU and the population served by the mobile emergency with chest pain.~     Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the~     final diagnosis and direction after passing emergency, cardiology and at follow-up to a~     year.~   "
138991|NCT01235585|"~     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally~     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics,~     will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52~     weeks, followed by an optional treatment extension for up to 3 years.~   "
138949|NCT01236144|"~     The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned~     to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate~     combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE~     (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily~     by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg~     flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to~     60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor~     Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin,~     Clofarabine). Patients/investigators will be able to choose which intervention to enter.~     Depending on recruitment requirements, only one intervention might be available at any one~     time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on~     days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The~     chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which~     will be associated with 3 administrations of ganetespib.~   "
138950|NCT01236131|"~     The goal of this project is to identify the microorganisms present in the endometrial~     samples obtained from women with or without evidence of endometritis using a combination of~     culture methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these~     studies is to identify the etiology of endometritis. The investigators will define the role~     of fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic~     treatment regimens used for the treatment of PID have activity against the novel organisms~     linked with pelvic infections.~   "
138951|NCT01236118|"~     The purpose of this study is to evaluate the safety and tolerability of LY2439821~     subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis~     who have completed Study I1F-JE-RHAL (NCT01253265).~   "
138952|NCT01236105|"~     The purpose of this study is to determine the effect of activated charcoal and dosing time~     on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three~     treatments with a washout period of at least 7 days in between treatments. Each subject will~     participate in all three treatments with random assignment to the treatment sequence.~   "
138953|NCT01236092|"~     The most common chronic low back pain conditions are a consequence of disc disease as well~     as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into~     the space containing the spinal cord or a nerve root resulting in severe pain. A common~     treatment is then surgery. Whole-body vibration combined with un-weighting traction and~     specific manual mobilization plus active therapeutic exercise seems to treat chronic low~     back pain by non-invasively firing muscles of the lumbar spine. The investigators are~     seeking to show such therapy reduces the need for surgery and significantly out performs~     traditional physical as the preferred conservative treatment.~   "
138954|NCT01236079|"~     The goal of this patient-randomized effectiveness trial is to demonstrate that an inpatient~     technology-supported assisted referral (I-TSAR) and follow-up approach is an effective and~     cost-effective method to help hospitalized patients successfully quit smoking. The proposed~     study represents a unique opportunity to assess the effectiveness and cost-effectiveness of~     linking inpatient and outpatient delivery of smoking cessation services in two large and~     very different health care delivery systems. We will enroll 900 participants (600~     intervention, 300 controls) over 15-months and collect follow-up survey and health care~     utilization data over 12 months to estimate: 1) smoking abstinence at 6 and 12 months for~     I-TSAR intervention recipients compared to usual care; 2) the dose effect on smoking~     abstinence at 6 and 12 months for I-TSAR recipients compared to usual care; 3) total and~     mean costs per participant for I-TSAR and usual care recipients, and, if effective, estimate~     the incremental cost-effectiveness of the intervention vs. controls at 12 months from health~     plan/insurer and societal perspectives; and 4) differences in health care utilization at 12~     months for I-TSAR versus controls.~   "
138955|NCT01236066|"~     This study aims to monitor the incidence rates and duration of hospitalisations for~     rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to~     2009, in children < 5 years of age after the introduction of Rotarix in 2006 by year, both~     inside and outside rotavirus season in Australia. It further aims to compare the two dose~     regimen of Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.~   "
138956|NCT01236053|"~     High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but~     there has been no post marketing pancreatic carcinogenicity signal with gabapentin as~     reported by spontaneous reports in AERS or in the published literature. In a published~     case-control screening study of the association of gabapentin with 55 cancers, the only~     cancer that met the screening criteria for possibly increased cancer risk with gabapentin~     exposure was renal (including renal pelvis) cancer. This association was judged to be likely~     due to or substantially accentuated by confounding by cigarette smoking, hypertension, and~     lifestyle (Cancer Causes Control 2009;20:1821-1835).~      The relationship between gabapentin exposure and pancreatic cancer and renal cancer is~     studied in NCT01138124, and supplemental analyses for these cancers are performed in the~     current study. The FDA recommended GSK also study the relationship between gabapentin and~     all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus,~     anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis,~     7) urinary bladder, and 8) other nervous system.~      The primary objective of this study is to determine whether exposure to gabapentin is~     associated with an increased risk of developing all-cancer, and these specific cancers in~     the United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK~     population is registered with a General Practice, which centralizes the medical information~     not only from the general practitioners themselves but also from specialist referrals and~     hospital attendances. Over 487 General Practices contribute data to the GPRD.~      The study cohort from which cases and controls are drawn is all subjects in the GPRD~     1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins~     Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of~     registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they~     have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with~     a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10~     controls within the same General Practice for age at cohort entry (within two years), sex,~     and year of entry into the study cohort (within one year). For cases, the index date is the~     date of first diagnosis of the respective cancer. The index date for controls is set as the~     date at which the follow-up time from cohort entry is the same as the case. The index date~     is chosen so as to give the control equal follow-up time to that of the case for~     ascertainment of use of gabapentin. Cases and controls will be required to have at least 2~     years of follow-up in the study cohort before their index date. Cases must have no history~     of any other cancer diagnosis prior to the index date. Controls are required to be free of~     cancer diagnosis in the database up to the control's index date.~      Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry~     to the index date. Gabapentin exposure will be assessed as ever/never, number of~     prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period~     incorporated to control for protopathic bias (gabapentin prescription for initial pain~     symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD~     cancer diagnosis).~      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from~     conditional logistic regression models, with additional analyses evaluating for~     dose-response. Covariates include indications for gabapentin use and risk factors for each~     cancer.~   "
138957|NCT01236040|"~     This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate~     vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.~   "
138958|NCT01236027|"~     Biologic samples are necessary for development and validation of laboratory procedures (e.g.~     novel biological and analytical assays, explant tissue models, validation of specimen~     collection and transport) to support future infectious disease clinical studies. In this~     research study, the investigators will collect blood samples, vaginal swabs, cervical swabs,~     mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as~     necessary, to use in the development of laboratory processes. The investigators will obtain~     the sample(s) from healthy HIV negative women. Samples will be collected and sent to~     Magee-Womens Research Institute as laboratory specimens are needed.~   "
138959|NCT01236014|"~     An indirect comparison to compare the efficacy of eltrombopag versus romiplostim~   "
138960|NCT01236001|"~     Observational study at the request of the Belgian Institut National d'Assurance~     Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:~        -  type of patient treated with VIMPAT®~        -  VIMPAT® dose~        -  Effect of VIMPAT® on evolution of seizure control~        -  Persistence rate at 6 months in terms of treatment duration~        -  Discontinuation rate~        -  Description of any changes in other epilepsy therapies~        -  Safety and tolerability~   "
138961|NCT01235988|"~     The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo~     (standard of care)~   "
138962|NCT01235975|"~     This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine~     GSK 134612 given as single dose to healthy adults 56 years or older compared to the~     meningococcal polysaccharide vaccine MencevaxACWYTM.~   "
138963|NCT01235962|"~     This randomized Phase III study is to evaluate whether pazopanib compared with placebo can~     prevent or delay recurrence of kidney cancer in patients with moderately high or high risk~     of developing recurrence after undergoing kidney cancer surgery~   "
138964|NCT01235949|"~     The aim of the current study is to determine whether ibuprofen, given as immediate or~     delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts~     the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK)~     Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined~     vaccines, at 3, 4 and 5 months of age.~      In addition, this study will further evaluate the impact of prophylactic administration of~     paracetamol following primary vaccination with immediate or delayed administration or when~     given in an immediate manner at the time of the booster dose.~   "
138965|NCT01235936|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of~     repeat doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.~   "
138966|NCT01235923|"~     Preterm infants are a risk for multiple transfusions, and the administration of human~     recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing~     usually occurs three times a week, but extended dosing schedules have been successful in~     adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard~     three times weekly dosing.~   "
138967|NCT01235910|"~     The purpose of this study is to evaluate the safety and efficacy of the blood pressure~     medication, aliskiren, in heart transplant patients. In terms of safety, the investigators~     will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood~     levels of the anti-rejection medication, cyclosporine, in these patients. In terms of~     efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart~     transplant patients.~   "
138968|NCT01235897|"~     The purpose of this study is to test the safety and safest highest dose of an~     investigational drug called MK-2206 when given in combination with paclitaxel and~     trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing~     solid tumor malignancies.~   "
138969|NCT01235884|"~     Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days~     of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive~     disorders such as regurgitation and constipation.~      Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42~     gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or~     placebo for 28 days.~      After the inclusion, at baseline will be performed :~        -  Paediatric visit~        -  antropometric valutation~        -  number of the daily crying minutes, number of regurgitation and number of daily~          evacuation~      The patients will receive the probiotics/placebo every days for 28 days and the 29th will be~     repeated the following analyses:~        -  Paediatric visit~        -  antropometric valutation~        -  number of daily crying minutes~        -  numbers of regurgitation~        -  numbers of evacuations~      Primary outcome :~      To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic,~     regurgitation and of constipation.~      Inclusion criteria~        -  neonates of 37-42 week gestational age and appropriate birth weight~        -  Recruitment age: until 7 days of life~        -  Informed consent signed~      Exclusion criteria~        -  Presence of other gastrointestinal diseases.~        -  Use of FANS, aspirin or other drugs~        -  Use of antibiotics and/or PPIs e/o anti-H2~        -  Participation to other clinical trials~   "
138970|NCT01235871|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of SB1578 in healthy volunteers.~   "
138971|NCT01235858|"~     There is an increasing trend in the incidence of infection related to epidural anesthesia.~     This could be related to methods of aseptic technique as adopted by the anesthesiologist~     during the performance of the procedure.~      The purpose of this study is to compare two methods of aseptic technique for labor epidural~     insertion; a conventional method without wearing a sterile gown (free from living germs or~     microorganisms) versus strict aseptic method with wearing of sterile gowns.~      It is our belief that there will be an increased contamination of epidural equipment and~     colonization of epidural catheter, secondary to bacterial fallout from the operators' bare~     hands in the group not wearing the sterile gowns.~   "
138972|NCT01235845|"~     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis~     carries with it a median survival of approximately 12 months, with 90 - 95% of patients~     surviving less than 2 years. The current standard treatment of surgical resection followed~     by radiation therapy and chemotherapy has not substantially prolonged survival.~      Dendritic cells (DCs) are immune cells that form part of the mammalian immune system. Their~     main function is to process antigen material and present it on the surface to other cells of~     the immune system, thus functioning as antigen-presenting cells.In the present study, DCs~     were used for antigen presentation of glioma antigens to directly induce a cytotoxic T-cell~     response. Cytokine-induced killer (CIK)cells are shown to be a heterogeneous population, and~     the major population expresses both the T cell marker CD3 and the NK cell marker CD56, and~     is termed NKT cells, which has shown significant anti-tumor activity in both clinical trials~     and animal studies.~      Furthermore, CIK cells are able to expand significantly when they are cultured with DCs, and~     the CIK cells activated by DCs stimulation (DCIKs)have a characteristic which cytotoxic~     activity enhanced and show increased anti-tumor activity.~      This study aimed to evaluate the clinical efficacy of DCIK cells treatment combined with DCs~     following tumor resection and radiotherapy in patients with malignant glioma.~   "
138973|NCT01235832|"~     The investigators propose to evaluate the effects of avocado consumption (by incorporating 1~     unit of fruit per day into a healthy diet) on multiple cardiovascular disease (CVD) risk~     factors. The investigators will compare chronic consumption of a moderate fat blood~     cholesterol-lowering diet incorporating one avocado per day versus a blood~     cholesterol-lowering Lower-Fat diet on established CVD risk factors including lipids and~     lipoproteins, and blood pressure (BP). The investigators also will evaluate the effects of~     an avocado diet on several emerging CVD risk factors. To elucidate the specific benefits of~     avocado and its accompanying bioactives on the aforementioned risk factors, the~     investigators will compare the avocado diet with a diet that has the same macronutrient~     profile (but without the avocado).~   "
138974|NCT01235819|"~     To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1~     diabetes patients.~   "
139021|NCT01235195|"~     This study is designed to determine differences in drug exposure in subjects after being~     administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after~     administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.~   "
138975|NCT01235806|"~     The Alpes Maritimes county administration (France) equipped Nice University Hospital of a~     0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the~     medical imaging unit.~      The aim of our project is to study its interest in diagnosis of scaphoid fractures.~      Conventional medical care for patients being suspected to have a scaphoid fracture consists~     in performing a clinical examination and a radiographic check-up with at least 4 incidences,~     which 2 specific incidences for the scaphoid bone.~      Yet, this check up is sometimes defective, causing false positives unnecessary~     immobilisation and false negatives delays in patient medical care, increasing the risk of~     complication. Those diagnosis mistakes can bring serious consequences, from permanent~     partial inability, to professional reclassification.~      Alternative imaging exists, but is often irradiating, and never reaches the optimal~     specificity and sensitivity.~      MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of~     cases. The problem is the lack of accessibility for emergency cases; therefore there is a~     great interest in validating the use of a MRI dedicated to distal articulations.~      The few studies that study costs of diagnosis strategies including MRI in scaphoid bone~     fractures diagnosis show a reduction of medical costs if this technique is used early. Our~     project represents an essential initial step in evaluating the impact of a low field MRI~     dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will~     be a medico-economical study, since scaphoid fractures occur frequently.~      Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.~   "
138976|NCT01235793|"~     The primary purpose of the study will be testing the dosing of temozolomide to find the~     target dose that a person can tolerate. The other part of the study will be determining how~     helpful it can be to CNS lymphoma patients by adding temozolomide to the conditioning~     regimen prior to stem cell transplantation.~      This research study is designed to test the investigational use of temozolomide as part of a~     conditioning regimen prior to stem cell transplantation. This drug has not yet been approved~     by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell~     transplantation in lymphomas of the brain (central nervous system or CNS) but it has been~     studied and used before in transplantation with reasonable results.~   "
138977|NCT01235780|"~     The purpose of the study is to investigate the factors affecting corneal hysteresis (CH) in~     Taiwanese.~   "
138978|NCT01235767|"~     The purpose of this study is to determine if a nutrient-rich supplement of animal-source~     foods ingested 5d/wk from pre-conception to term improves maternal nutrient status,~     decreases infections, and improves birth weight and rates of prematurity compared with~     supplemental ingestion during pregnancy ( from mid-gestation to term) or routine prenatal~     care.~   "
138979|NCT01235754|"~     The objective of this study is to evaluate the persistence of benefit of LibiGel~     (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of~     Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.~   "
138980|NCT01235741|"~     Following screening, eligible subjects will be enrolled into a 6‑week Low Calorie Diet (LCD)~     lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week~     LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or~     placebo) to begin a 16-week treatment period during which the effect on body weight of~     treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week~     blinded core treatment period, subjects will discontinue study medication for a period of 12~     weeks. Following the 12 week off-drug follow-up period, subjects in both groups will~     initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12~     week off-drug and 12 week open label treatment periods, subjects will continue to~     participate in a Lifestyle Intervention (LSI) program.~   "
138981|NCT01235728|"~     This is a within-participant comparison study to investigate the efficacy of a 28-day~     regimen of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching~     placebo) b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in~     participants with plaque psoriasis. In order to be enrolled in the study, patients need to~     have at least two pairs (lesions AB and CD) of approximately similar plaque lesions in~     severity and size of surface area involved and located in approximately symmetric regions~     such as the trunk or limbs of the body. Participants will be randomly assigned to apply~     either MK-0873 or MK-0873 vehicle to plaque A or B and will be randomly assigned to apply~     MK-0873 or calcitriol to plaque C or D. It is hypothesized that MK-0873 cream formulation~     administered to participants with psoriasis by the topical route will result in a~     statistically greater percent target lesion severity (TLS) reduction in plaque lesion than~     will MK-0873 Vehicle on Day 29.~   "
138982|NCT01235715|"~     Application of Evicel hemostatic matrix during operation for unilateral total knee~     replacement surgery (TKA) will result in decreased bleeding and postoperative drain output,~     a reduction in transfusion requirements, and less reduction of hemoglobin.~   "
138983|NCT01235702|"~     A 12-week treatment/control trial was implemented to assess the effects of a multi component~     lifestyle program on improvements in body mass index, weight, perceived stress and blood~     pressure in African American men and women who were at increased risk for cardiovascular~     disease. It was hypothesized that treatment group would experience significant improvements~     when compared to the control group.~   "
138984|NCT01235689|"~     Efficacy and Safety of two treatment models in subjects with moderate to severe Crohn's~     Disease.~   "
138985|NCT01235676|"~     0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle~     intervention during pregnancy~   "
138986|NCT01235663|"~     0-hypothesis: advisory support does not~        1. prolong the the breast-feeding period~        2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers~   "
138987|NCT01235650|"~     This is a retrospective chart review of patients undergoing spinal fusion surgery to see the~     prevalence of hyperventilation.~   "
138988|NCT01235637|"~     The main objective is to assess the efficacy of Alfentanil for pain in children treated by~     tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the~     current standard treatment.~   "
138989|NCT01235624|"~     Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of~     the most common causes of hereditary diseases of the retina, and thus better understand the~     mechanisms involved of the disease.~   "
138992|NCT01235572|"~     This phase II trial studies how well early discharge and outpatient care works in patients~     with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive~     chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute~     myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the~     hospital until blood counts return to normal, may help doctors learn more about the safety~     of allowing patients to leave the hospital early, the patient's quality of life, use of~     medical services, and the cost of these services associated with such a policy.~   "
138993|NCT01235559|"~     This randomized, multi-center double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally~     controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics,~     will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52~     weeks, followed by an optional treatment extension for up to 3 years.~   "
138994|NCT01235546|"~     The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic~     multi-center randomized clinical trial designed to evaluate the comparative effectiveness~     and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus~     standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin~     (preferably prior to surgical incision) to prevent post-cesarean infection.~      Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if~     cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum~     prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.~   "
138995|NCT01235533|"~     To investigate whether fish oil supplementation, compared to placebo (olive oil), could have~     better effects on depression course and cognitive function in older people with major~     depression.~   "
138996|NCT01235520|"~     This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled~     symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be~     randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,~     followed by an optional treatment extension for up to 3 years.~   "
138997|NCT01235507|"~     This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra~     (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe~     rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic~     drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800~     mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued~     at a stable dose. Anticipated time on study treatment is 24 weeks.~   "
138998|NCT01235494|"~     To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The~     goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to~     multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe~     recruited from the local research group and the results compared with existing methods that~     require seperate breath-holds of 3He gas~   "
138999|NCT01235481|"~     The Public Health Agency of Canada estimates that over 3.5 million Canadians live with~     chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep~     apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of~     chronic lung disease among Canadian provinces, likely a reflection of both the age of the~     population and high rates of exposures to occupational dusts and smoking. Pulmonary~     rehabilitation is a multidisciplinary intervention, involving exercise and education for~     patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to~     improve patient symptoms, exercise capacity, and quality of life while reducing health~     resource utilization. Many studies have shown that the benefits of pulmonary rehabilitation~     tend to diminish over time after program completion. The best interventions to maintain the~     benefits of pulmonary rehabilitation remain unclear.~      The purpose of this study is to validate incorporation of an exercise DVD into a maintenance~     program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from~     pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual~     care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study~     subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion~     of pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome~     measures will include exercise capacity, exercise compliance, health-related quality of~     life, confidence with performing exercise, and satisfaction with the exercise DVD. The~     primary outcome measure will be a change in functional exercise capacity as determined by~     the distance walked in 6-minutes, a commonly used and validated assessment tool for patients~     with chronic lung disease.~   "
139000|NCT01235468|"~     The aim of this study is to evaluate the safety profile and tolerability of infusion of cord~     blood cells expanded in the lab and to evaluated whether through the infusion of expanded~     cells it is possible to expedite engraftment time after transplantation.~   "
139001|NCT01235455|"~     This is an observational survey to assess the factors that influence adherence to Betaferon~     therapy in multiple sclerosis patients using elements of the BetaPlus support program,~     including the nurse support and auto-injectors. The patients were evaluated under normal~     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping~     processes (WCQ) and depression questionnaire CES-D.~   "
139002|NCT01235442|"~     The primary hypothesis of this trial is that the addition of short courses of clobetasol~     propionate foam to etanercept monotherapy in subjects with moderate to severe plaque~     psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by~     PASI 75 at Week 12.~   "
139003|NCT01235429|"~     Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related~     complications decrease quality of life and can result in early morbidity. The purpose of the~     Partners in Care diabetes self-management educational intervention is to teach participants~     how to manage their diabetes to avoid or delay diabetes-related complications and how to~     better work with their health care team.~   "
139004|NCT01235416|"~     This study is an open-label, dose-finding study to determine the target or maximum-tolerated~     dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in~     combination with erlotinib with or without gemcitabine in subjects with solid tumors.~   "
139005|NCT01235403|"~     To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of~     400 mg/day, or to a clinically effective lower dose for an individual patient, improves the~     tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients~     with partial onset epilepsy.~      Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility~   "
139047|NCT01234857|"~     This is a two-part study that will determine, if: 1) the combination of ridaforolimus and~     dalotuzumab will improve progression-free survival compared to exemestane; and 2) the~     combination of ridaforolimus and dalotuzumab will improve progression-free survival compared~     to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.~   "
139006|NCT01235390|"~     The purpose of this study is to determine the effects of the 4-week consumption of~     California walnuts on vascular function and immune health in postmenopausal women of ages~     50-70.~      Primary outcome measures:~        -  vascular endothelial function~        -  platelet reactivity~        -  indoleamine 2, 3-deoxygenase (IDO)~      Secondary outcome measures:~        -  relationship of walnut intake to lipoprotein, fatty acids and oxylipins~   "
139007|NCT01235377|"~     This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead~     of putting single patients into one of two drug groups, the investigators will assign the~     doctors who prescribe these drugs for high blood pressure into two groups. One group of~     doctors has agreed to prescribe mostly (favor) one drug, chlorthalidone, if that drug~     would be a good choice for a patient. The other group has agreed to prescribe mostly~     hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be~     protective in other trials. If the doctors mostly prescribe the drug they agreed to favor,~     the investigators will be able to compare outcomes, like heart attacks, in the two groups.~   "
139008|NCT01235364|"~     The purpose of this study is to assess pain in women randomised to digital or speculum~     placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also~     to be evaluated as well as maternal satisfaction with induction of labour.~   "
139009|NCT01235351|"~     To determine whether higher as compared with lower maintenance doses of clopidogrel can~     adequately improve the degree of platelet inhibition in carriers of a reduced-function~     CYP2C19 allele.~   "
139010|NCT01235338|"~     This study will examine the effects of co-administration of SPD489 and the antidepressant~     EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In~     addition, serial blood pressure and pulse measures will be obtained and examined to ensure~     that there are no unexpected changes in vital signs following co administration of SPD489~     and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis~     is that a drug drug interaction could possibly exist.~   "
139011|NCT01235325|"~     To assess the impact of a 12 month vitamin K supplementation intervention on bone health in~     adult Crohn's disease patients~   "
139012|NCT01235312|"~     Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons~     to address this highly visible area, although no specific statistics concerning the number~     of patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of~     fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above~     mentioned therapies have been reported in the literature, but still there is a lack of~     scientific literature about functional microcirculation of the dorsum of the hand.~      Furthermore, there is a lack of scientific data about functional microcirculation of the~     plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or~     peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation~     of the functional microcirculation of hands and feet in healthy subjects as well as patients~     suffering from the above mentioned diseases.~   "
139013|NCT01235299|"~     In case of free flap failure, time is of utmost importance as salvage rates have been~     reported to be inversely related to the time interval between the onset of ischemia and its~     clinical recognition. Consecutively, monitoring of free flaps remains of major importance.~     Currently, combined Laser-Doppler and Spectrophotometry is available to determine~     microcirculation of free flaps in reconstructive surgery as a scientific method of reliable~     assessment of flap perfusion. The investigators thought to analyze the correlation of free~     flap skin temperature and free frap microcirculation as an accurate tool of postoperative~     flap monitoring.~   "
139014|NCT01235286|"~     Background: In plastic and reconstructive surgery, free flaps are routinely used for~     treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap~     necrosis by conditioning tissue tolerance against ischemia. Although previous studies~     indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few~     studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of~     this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on~     a potential free flap location in a human in-vivo setting for the first time.~      Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation,~     arterial capillary blood flow and postcapillary venous flow in a remote free flap donor~     location. To what extent remote preconditioning might ameliorate the reperfusion injury of~     free flap transplantation, further clinical trials have to evaluate both in the means of~     microcirculatory assessment and partial or total flap loss as end points of these studies.~   "
139015|NCT01235273|"~     The objective of the study is to determine whether treatment of the low IGF-1 syndrome in~     patients with CHF is able to modify some functional parameters, recognized as valid~     surrogate end-points of CHF progression.~   "
139016|NCT01235260|"~     The purpose of this study is to evaluate risk of cancer incidence and mortality associated~     with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S.~     Veterans Health Administration.~   "
139017|NCT01235247|"~     Computer-generated clinical reminders offered to providers will improve compliance with care~     guidelines and impact outcomes in resource-limited clinics.~   "
139018|NCT01235234|"~     Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24~     weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear~     production, and patient symptoms.~   "
139019|NCT01235221|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple~     sclerosis (MS) who previously participated in the registrational and extension studies~     conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908~     (MS-F203EXT) and NCT00649792 (MS-F204EXT).~   "
139020|NCT01235208|"~     The background for the trial is a number of previous studies indicating that it is~     especially important to restrict the intake of carbohydrates when treating overweight and~     metabolic diseases in general.~      The purpose of the study is to obtain research data on the effects of an established~     treatment of overweight/obesity and its related metabolic disorders. The treatment, Dr.~     Fedon Lindbergs Vektcoach, is a combination treatment where patients use low carbohydrate~     and low energy Eurodiet products in the initial phases. After the initial phases are~     completed, low glycemic normal foods are added to the diet until a sustainable and healthy~     diet is achieved. The treatment is of 7 month duration.~   "
139022|NCT01235182|"~     Acute heart failure is one of the main causes of acute respiratory distres in prehospital~     emergency setting. The early and correct diagnosis is important because the misdiagnosis can~     result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and~     point-of-care lung ultrasound could be useful methods in field. This study confirmed that~     the combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh~     diagnostic accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea~     in the field and the tretament possibilities in clinical obscure cases are mainly improved.~   "
139023|NCT01235169|"~     This is an open multicenter study, evaluating a new operative technique in femur neck~     fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter~     fracture due to osteoporosis.There two routine surgical techniques in femoral neck~     fractures:~        1. Insertion an intramedullary nail (without augmentation) to the bone.~        2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is~          the relative high rate (4-10 precentages) of failure because of the femur head bone~          which is very brittle and osteoporotic.~      This new approach enables the nail a better grip as a result of the cement augmentation~     which consists of PMMA (Polymethyl methacrylate).~      The investigators main goal is to evaluate the use of this surgical technique~   "
139024|NCT01235156|"~     Arrhythmia is a common disease that may be caused by various cardiovascular diseases.~     According to statistics, 500,000 people die of severe arrhythmia every year in China, In the~     United States, approximately 540,000 patients die each year.This study will evaluate the~     effectiveness safety of sulcardine sulfate tablets in the patients with premature~     ventricular contractions (and non-sustained VT).~   "
139025|NCT01235143|"~     Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless,~     sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane~     and isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of~     emergence agitation compared to sevoflurane in unpremedicated preschool children under~     elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile~     anesthetic agent which provides faster recovery compared to sevoflurane.Valley et~     al.reported no significant differences between sevoflurane or desflurane anesthesia in~     children in term of the serious airway complication such as laryngospasm or desaturation~     excepted the number of coughing episodes were more frequent in the desflurane compared to~     sevoflurane (36 versus 18).Mayer J et al. reported sevoflurane had severity of Pediatric~     Anesthesia Emergence Delirium (PAED) scale higher than desflurane in ear, nose, throat~     inpatient surgery in children (12(2-20) versus 6(0-15) respectively) with no reported of~     incidence of emergence agitation between those two. Therefore, the investigators would like~     to compare the incidence of emergence agitation, recovery profile and respiratory events~     between desflurane and sevoflurane anesthesia in pediatric ambulatory urologic surgery under~     general anesthesia and combined with regional anesthesia.~   "
139026|NCT01235130|"~     The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids,~     2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal~     or persistent AF in whom a rhythm-control strategy is planned.~   "
139027|NCT01235117|"~     RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~      PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well~     it works in treating patients with chronic myelomonocytic leukemia.~   "
139028|NCT01235104|"~     The aim of this study is to investigate the outcomes of total nephrectomy on patients with~     kidney stone disease.~   "
139029|NCT01235091|"~     Women Teaching Women (WTW) is proposed by a team of Washington University investigators who~     have focused on HIV prevention efforts among out-of-treatment injecting drug users (IDUs)~     and crack cocaine users, since 1988. Our peer-delivered prevention model was successful in~     reducing cocaine use among men. The investigators believe no differences were found in drug~     and sexual risk behaviors for women because the intervention lacked gender-specificity.~     Thus, the investigators propose to tailor our previous intervention to women's needs to~     determine the shorter and intermediate term effectiveness of a gender-specific model on~     reducing drug use and sexual risks. The urgency for women-focused interventions is~     highlighted by increasing HIV/STD rates among women nationwide. The intervention is designed~     to bring the HIV prevention message to women in a public health environment. The three-arm~     intervention, which targets out-of-treatment drug-using women, will assess the differential~     impact of a woman-centered standard intervention alone, the same standard intervention plus~     a well-woman exam, and those plus the addition of 4 educational sessions. This proposal~     responds to two NIDA PAs: 95-083 (Women's HIV Risk and Protective Behaviors) and 96-018~     (Drug Abuse Prevention Intervention for Women and Minorities). Our risk reduction,~     epidemiological and technology transfer aims include:~      Risk Reduction Aims:~        1. Recruit out-of-treatment female drug injectors, heroin, crack/cocaine and~          methamphetamine users to into an intervention aimed at reducing high risk sexual and~          drug use behaviors. Street outreach, bars and clubs, shelters, health fairs and daycare~          facilities will be used to reach these vulnerable women at risk.~        2. Administer a modified theory-based, peer-delivered, gender and culture-specific~          intervention that encourages women to reduce their high risk drug and sexual behaviors.~          Women will be randomly assigned to one of three peer-delivered interventions: a~          modified NIDA Cooperative Agreement Standard Intervention (SI), the SI + Well-Woman~          Exam (SI+WWE), or the SI+Well-Woman Exam + 4 Educational Sessions (SI+WWE+4ES). The~          Standard Intervention will be delivered by peers; the Well-Woman Examination will be~          conducted by a nurse practitioner; the four 2 hour educational sessions will be~          conducted by peer facilitators from area drug treatment programs paired with a~          community mental health or health professional.~        3. Assess the effectiveness of the interventions in reducing drug and sexual risk at 4 and~          12 months post-intervention, controlling for baseline characteristics.~        4. Evaluate the relative cost-effectiveness of each intervention.~           Epidemiologic Aim:~        5. Assess: a) incidence of HIV, Hepatitis B and C, syphilis, chlamydia and gonorrhea 12~          months post-intervention; b) change in HIV risk and drug and alcohol use at 4 and 12~          months post-intervention; c) the effect of psychopathology on behavior change at 12~          months post-intervention; d) lifetime history of substance abuse and service~          utilization for mental and physical problems at baseline.~           Technology Transfer Aim:~        6. Disseminate findings to the scientific community, practitioners and community members~          in formats that are appropriate, understandable, and usable in order that the best~          possible women-centered intervention can be developed for reducing HIV risk behaviors.~          The investigators propose to create a WebSite and present findings at local, national~          and international symposia. Manuals describing the interventions will be developed and~          made available to the field.~   "
139030|NCT01235078|"~     The purpose of this study is to evaluate the use of powered intraosseous vascular access~     (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular~     access. Data collected will be compared to historical data on central venous catheter use in~     the emergency department. The primary hypothesis is that powered intraosseous vascular~     access will decrease the amount of time needed to obtain vascular access.~   "
139031|NCT01235065|"~     The purpose of this study is to assess if the GlideScope video laryngoscope is superior to~     the Macintosh direct laryngoscope for definitive airway management in acutely-injured~     patients.~   "
139032|NCT01235052|"~     Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and~     skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and~     neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for~     assessment of distant metastases and synchronous second primary malignancies, hypoxia is one~     of the most important prognostic factors in radiotherapy of this type of tumors. The only~     gold standard method for direct determination of oxygen tension is based on using oxygen~     electrodes showing a good relation with clinical outcome but complex in its realisation. So,~     PET using 18F-FMISO has been described to be useful for the non invasive assessment of~     hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and~     there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a~     need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful~     tool for evaluation of new therapies and modification of volumes in radiotherapy.~   "
139033|NCT01235039|"~     The primary objective of this study is to test for bioequivalence of VIAject®7 and~     VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics~     of VIAject®7 with those of VIAject®25 and insulin lispro.~   "
139034|NCT01235026|"~     The purpose of this study is to determine whether the daily administration of a synbiotic~     (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to~     improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic~     concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese~     subjects.~   "
139046|NCT01234870|"~     The purpose of the study is to assess the diagnostic performance of fully automated motion~     corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected~     first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart~     disease, using coronary angiography as the reference standard. It is expected that this~     improved comprehensive protocol for cardiac MRI be accurate at detecting significant~     coronary artery disease and may obviate the need for other more expensive and invasive~     diagnostic tests currently used.~   "
139035|NCT01235013|"~     Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor~     inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in~     treated and naïve patients, irrespective of the viral load.~      The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of~     discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3~     during the last year, could lead to its immunological recovery.~      60 patients will be included in this unicentric, prospective, randomized and stratified~     clinical trial. They will be randomized to either continue with its usual high activity~     antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours~     plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as~     safety, clinical progression, immunological profile of the patients and the potential~     benefit of Maraviroc for HIV+ cirrhotic patients.~   "
139036|NCT01235000|"~     Each winter, viruses belonging to two kinds of influenza A (A/H1N1 & A/H3N2) and two~     kinds of influenza B (B/Yamagata & B/Victoria) can cause illness. The yearly influenza~     vaccine is designed to protect against both kinds of influenza A but only one or the other~     kind of influenza B. Current recommendations in Canada are that if an eligible child less~     than nine years of age has received two doses of influenza vaccine before, then that child~     only requires a single dose of influenza vaccine in subsequent years of immunization. In a~     previous study conducted in early 2010 we measured the antibody response to influenza B in~     children who had previously received two doses of a B/Yamagata kind of virus contained in~     the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in~     the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the~     protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus~     that was in the 2009-10 vaccine can be improved with another (second) dose of the same~     B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness~     especially of children, understanding how to best protect children against both kinds of~     influenza B is important.~   "
139037|NCT01234987|"~     The purpose of this study is to collect breath samples from healthy and cancer sick~     patients. The breath, collected to special bags, will be transferred to laboratories in the~     Technion and analyzed using an electronic nose system developed in Hossam Haick's labs~     (Chemical Engineering, Technion). The hypothesis is that based on the analysis of the~     chemical bio-markers present in the exhaled breath, cancer states can be distinguished from~     healthy subjects or before and after treatment, allowing a technique for diagnosis of cancer~     and/or cancer treatment.~   "
139038|NCT01234974|"~     Observe the safety/tolerability and effectiveness in terms of response rate and duration of~     response of the combination pasireotide + everolimus in the treatment of patients with~     relapsed/refractory multiple melanoma.~   "
139039|NCT01234961|"~     This project evaluates the outcomes of a work rehabilitation program, Redesigning Daily~     Occupations (ReDO), for women with stress-related disorders. The ReDO intervention focuses~     on how people compose their everyday lives. The basic idea is that re-structuring of an~     individual's lifestyle and pattern of daily occupations will lead to a healthier balance~     between the occupations of everyday life, and that this balance will promote wellness and~     increased work capacity. The program is group based and comprises 16 weeks.~      The aim is to evaluate ReDO for women with stress-related disorders. The project, which~     covers the time period from entering the program to a 12-month follow-up, is a~     quasi-experimental study. 42 women who entered the program and fitted the selection criteria~     were included. A matched comparison group was selected among those clients at the Social~     Insurance Office who get care-as-usual (CAU). Both groups are followed prospectively and~     are compared regarding return to work, sick leave, and different aspects of health and~     well-being. The hypothesis is that the ReDO group will improve more than the CAU group in~     all these respects.~   "
139040|NCT01234948|"~     The primary aim of the current study was to determine the association between halitosis~     detection (presence or absence) and periodontal status in non-smoking subjects, and also~     assess whether halitosis recordings were related to periodontal clinical parameters, tongue~     coating and quantities of two putative periodontal pathogens on the posterior region of the~     tongue determined by real-time PCR. Secondary, halitosis recordings were compared among~     subjects with chronic periodontitis, chronic generalized gingivitis and periodontal health.~   "
139041|NCT01234935|"~     RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether giving dasatinib together with~     gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating~     pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well giving~     dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine~     hydrochloride alone in treating patients with pancreatic cancer previously treated with~     surgery.~   "
139042|NCT01234922|"~     RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help~     lower blood pressure.~      PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril,~     ramipril, or losartan potassium works in treating hypertension in patients with solid~     tumors.~   "
139043|NCT01234909|"~     Atopic dermatitis is a chronic skin disease with pruritus as one of its main features.~     Because of the symptomatic nature of their condition, pediatric patients with atopic~     dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling~     behind in visits to their primary care provider. This cross-sectional study in patients~     attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common~     conditions associated with atopic dermatitis and subsequently treat or refer patients for~     appropriate care. The investigators hypothesize that Milwaukee County pediatric patients~     with atopic dermatitis will have a high prevalence of asthma needing treatment, missed~     immunizations requiring catch-up, and vitamin D deficiency necessitating replacement~     therapy.~   "
139044|NCT01234896|"~     Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study~     in healthy smokers.~   "
139045|NCT01234883|"~     The primary objective of this study is to compare the efficacy and safety of the use of a~     multiple electrolyte solution to the use of saline for the treatment of moderate to severe~     dehydration due to acute gastroenteritis (AGE) in children.~   "
139049|NCT01234831|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings.~     Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA~     infections have been associated with high costs and adverse clinic outcomes. Patients can~     clear MRSA spontaneously. Improved approaches for identifying patients who are no longer~     colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be~     used to improve identification of patients who are no longer colonized.~   "
139050|NCT01234818|"~     A prospective multicenter trial has been started in Korea to investigate the treatment~     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) in endometrial~     hyperplasia (EH) patients. The LNG-IUS is known as an alternative of oral progesterone~     agents without incurring the disadvantages of oral progestogens. Therefore, it is~     hypothesized that if the therapeutic efficacy of LNG-IUS is similar or above oral~     progesterone, LNG-IUS would be a standard treatment for the EH patients who don't want~     hysterectomy. LNG-IUS is inserted into uterus of which patients are histologically confirmed~     as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound~     is conducted every 3 months at outpatients The primary endpoint is response rate. Secondary~     endpoint is to estimate the consistency of the results between office endometrial aspiration~     biopsy and dilatation and curettage (D&C) procedure.~   "
139051|NCT01234805|"~     This clinical trial studies yoga therapy in treating patients with malignant brain tumors.~     Yoga therapy may improve the quality of life of patients with brain tumors~   "
139052|NCT01234792|"~     Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.~   "
139053|NCT01234779|"~     This randomized, double-blind, placebo- and active-controlled, parallel group study will~     evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute~     exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg~     or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients,~     with a 4-week follow-up period.~   "
139054|NCT01234766|"~     The purpose of the study is to learn about the safety and effectiveness of treating~     follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT)~     using 90-yttrium (Y) ibritumomab tiuxetan.~      The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly~     found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to~     the study treatment.~      Bendamustine is approved by the United States Food and Drug Administration (FDA) for the~     treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL)~     that has progressed during or within six months of treatment with rituximab or a~     rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat~     follicular lymphoma.~      Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or~     follicular, CD20-positive B-cell non-Hodgkin's lymphoma.~      90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or~     refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular~     NHL. It is also approved for the treatment of follicular NHL that is previously untreated~     with radioimmunotherapy and that achieved a partial or complete response to first-line~     chemotherapy.~      Study participants will will receive bendamustine and rituximab for up to 16 weeks. If~     participants' cancer responds well to the treatment with bendamustine and rituximab, they~     will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete,~     participants will be asked to return to the clinic every 3 months for a maximum of 10 years~     for follow-up visits.~   "
139055|NCT01234753|"~     The number of adults with congenitally malformed hearts is increasing. According to a~     prospective population-based cohort study from Sweden (1992-2001) the prevalence of~     cardiovascular defects was 9.1 per 1,000 births, which is comparable to other presented~     prevalence data in the world.On the basis of 9 million inhabitants, Sweden should have~     approximately 82000 born with CHD and approximately 20000 will, in adult age, need regular~     follow up in cardiac care. This is a result of the greater improvements within paediatric~     heart surgery and there is an increasing demand for continuous follow up in the healthcare~     system.[2] Guidelines from the European Society of Cardiology and the Canadian~     Cardiovascular Society recommend follow-up oriented towards both medical and psychosocial~     problems.~      Earlier studies have shown that adults with CHD have poor knowledge about their heart~     disease.The results are difficult to summarise because of the use of different instruments,~     methods and sample sizes. Most of the adults with CHD did not know their clinical diagnosis~     or what endocarditis was. However, we do not know if everyone in these studies was~     recommended endocarditis prophylactics or their definition of poor knowledge.~      At present different programmes for adults with CHD are established in hospital outpatient~     clinics. These studies describe the established programmes. They also address the needs for~     development of care e.g. a multicenter approach, transitions from paediatric to adult health~     care, delivery care in Europe, programmes for pregnancy, how to provide clinical strategies,~     health care resource utilization or outpatient nursing clinic for adults with CHD. But there~     is a lack of knowledge regarding how education and psychosocial support should be given to~     adults with congenitally malformed hearts and what effects that can be achieved. The aim is~     to evaluate the effects of a nurse-led intervention consisting of education by a~     computer-based educational programme and psychosocial support to adults with congenitally~     malformed hearts.~   "
139056|NCT01234740|"~     RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent~     high-grade glioma or brain metastases.~   "
139057|NCT01234727|"~     A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system~     commercially available in Germany & Holland.~   "
139058|NCT01234714|"~     The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic~     Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with~     post-operative complications.~   "
139059|NCT01234701|"~     The purpose of this multicenter study is to evaluate the agreement among expert radiologists~     in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in~     non-cirrhotic patients.~   "
139060|NCT01234688|"~     The investigators raised the hypothesis that exercise training would be associated with~     improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.~   "
139061|NCT01234675|"~     Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most~     of the patients with fibromyalgia complain of either non-restorative sleep or complaints of~     disturbed sleep due to pain. The proposed study is aimed at examining the effects of~     milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,~     double-blind, placebo controlled, two way crossover PSG study to explore the effects of~     milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or~     matching placebo.~   "
139063|NCT01234649|"~     A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the~     future health of the mother. GDM is often the culmination of years of unrecognized and~     unmodified diabetes risk factors that lead to overt and occult clinical manifestations~     during pregnancy. Systematic reviews of older studies conclude that 35-60% women with~     gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control~     groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially~     delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2~     and ß-cell mass shown to increase in animal models. This study will examine if the addition~     of liraglutide to metformin therapy is more effective than metformin alone in improving~     insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with~     prior GDM.~   "
139064|NCT01234636|"~     Cardiovascular disease is a major cause of mortality worldwide resulting in one out of three~     global deaths. One of the main characteristics of cardiovascular disease is impaired blood~     flow and increased formation of clots. Platelets are clot-forming cells responsible for~     prevention of bleeding. However, in disease state they may be overly activated and tend to~     stick to each other, promoting blood clots and blockage of vessels.~      Conjugated linoleic acids (CLA) are unique fatty acids present in dairy food products and~     beef which would help to prevent platelets from clotting and thus help to prevent~     cardiovascular disease. However, the mechanisms by which those fatty acids affect platelet~     function are not yet fully understood. We designed a human intervention study assessing the~     mechanisms by which CLA beneficially affect platelet function and markers of haemostasis and~     inflammation in humans.~   "
139065|NCT01234623|"~     Human autologous serum (AS) eye drops have been successfully used in the treatment of severe~     ocular surface disorders and the enhancement of corneal wound healing, due to their growth~     factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and~     the objective of the study was to prove whether UCS eye drops~        1. are effective in the healing of corneal epithelial defects.~        2. ameliorate the painful subjective symptoms~   "
139066|NCT01234610|"~     An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta,~     which is a large blood vessel in the abdomen. Large AAAs (>55 mm diameter) carry a high risk~     of rupture, a surgical emergency that often leads to death due to severe internal bleeding.~     It has been suggested that regular exercise training might limit the rate at which AAAs~     develop. However, little is known about the safety and effectiveness of exercise training in~     these patients. This pilot study will examine the feasibility of supervised aerobic exercise~     training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize~     that exercise training will be safe and useful for patients with small AAAs.~   "
139067|NCT01234597|"~     Primary Objective:~      To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose~     monitoring, on glucose control in type 2 diabetes patients who are not controlled by~     treatment with once daily basal insulin or mixed insulin, requiring treatment with basal~     plus regimen~   "
139068|NCT01234584|"~     The purpose of this present study is to compare alveolar bone changes and markers of~     gingival health around the new Lanes® dental implant which were rehabilitate using the new~     switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.~   "
139069|NCT01234571|"~     Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for~     administration in the intravenous route. It is approved for treatment of class I - pulmonary~     hypertension functional capacity stage III-IV. A key factor for the success of pulmonary~     hypertension therapy is maintaining near constant blood level of a given medications along~     the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt~     increase in the pulmonary artery pressure which might lead to acute right ventricular~     failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy~     due to end-stage renal disease there is a need to document the variation of the blood level~     along the dialysis cycle.~   "
139070|NCT01234558|"~     The purpose of this study is to determine whether GLYX-13 reduces depression score in~     patients with treatment-resistant depression.~   "
139071|NCT01234545|"~     This trial is conducted in Africa and Asia. The aim of this study is to evaluate the~     efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated~     recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.~   "
139072|NCT01234532|"~     This phase II trial is studying how well giving entinostat and anastrozole together works in~     treating postmenopausal women with triple-negative breast cancer that can be removed by~     surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone~     therapy using anastrozole may fight breast cancer by blocking the use of estrogen by the~     tumor cells. Giving entinostat together with anastrozole may be an effective treatment for~     breast cancer.~   "
139073|NCT01234519|"~     The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients~     with a tumor of the urinary system.~   "
139074|NCT01234506|"~     A major means whereby oxidative stress promotes aging-related disease is by activating~     inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many~     of the problems associated with aging, including vascular dementia, Alzheimer's disease,~     osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome.~     Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein~     inducers decrease oxidative stress and associated inflammation. The flax lignan~     secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2~     protein inducer. Animal and human studies have shown that consumption of flax seed or its~     component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of~     experimentally-induced cancers as well as metastases of human breast tumours implanted into~     nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in~     modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and~     exerting control over cell differentiation. Adequate levels of vitamin D also appear to~     promote better glycemic control. The investigators predict that consumption of SDG in~     persons with adequate vitamin D status will decrease oxidative stress and associated~     inflammation. If this hypothesis is upheld, this research has the potential to greatly~     decrease healthcare costs while allowing healthier aging.~   "
139075|NCT01234493|"~     The aim of our study was to determine whether transfixation of unstable syndesmosis is~     necessary in supination-external rotation type ankle fractures. Our hypothesis was that~     syndesmotic ligaments heal at the proper length after malleolar reduction and that~     syndesmotic transfixation is not needed in supination-external rotation fracture types.~   "
139076|NCT01234467|"~     The purpose of this research study is to learn about the safety of the treatment with a~     combination of bendamustine and rituximab and to find out what effects, both good and bad~     this treatment has on DLBCL. In addition to learning about the combination of bendamustine~     and rituximab, the researchers are interested in learning about how this cancer treatment~     affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA).~     GAs are designed to gather information on memory, nutritional status, mental health, and~     level of social support. GAs are also designed to help the health care team understand how~     well subjects can carry out their day to day activities and to briefly describe what other~     medical conditions subjects may have. This assessment will help the health care team~     understand a subject's functional age (the age a subject functions at) as compared to a~     subject's actual age.~      The researchers also want to learn how chemotherapy affects the aging process in our bodies.~     This is done by measuring the amount of p16 in blood. Researchers want to understand if~     chemotherapy changes the levels of p16 in blood.~   "
139077|NCT01234454|"~     The general aim is to compare the effects of typical and atypical antipsychotic medication~     on brain structure and function. A parallel group treatment trial will be utilized to~     compare the effects of the typical antipsychotic thiothixene versus the atypical~     antipsychotics risperidone (RIS) and olanzapine (OLZ) on brain structure and function in~     schizophrenia in an effort to determine the neuroanatomic basis for cognitive pathology in~     schizophrenia and its amelioration by atypical antipsychotic drugs.~   "
139078|NCT01234441|"~     Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer~     from a variety of co-morbid diseases, many of which may be mechanistically linked. Protein~     malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced~     muscle strength, declines in physical function, and low levels of physical activity.~     Physical inactivity exacerbates these functional declines, and also promotes cardiovascular~     disease (CVD) and bone disorders. This cycle of disease and disability greatly reduces~     quality of life (QOL) and increases mortality rates in dialysis patients.~      Many factors contribute to the development of these co-morbidities. Chronic inflammation is~     believed to be a cause and a consequence of the protein malnutrition, CVD and bone disorders~     in dialysis patients. In addition, abnormalities in mineral metabolism resulting from the~     deficit in kidney function promote the loss of mineral from bone and the deposition of~     mineral in the vasculature, a process termed vascular calcification (VC). VC is associated~     with a variety of CVD-related disorders, including arterial stiffness, increases in arterial~     wall intima-media thickness (IMT), left ventricular hypertrophy (LVH), and declines in~     cardiac function. As a result of these abnormalities, cardiovascular events are 10 to 30~     times greater in dialysis patients than in age- and sex-matched subjects in the general~     population.~   "
139079|NCT01234428|"~     The purpose of this study is to determine whether esophageal dysmotility and dilatation is~     an important complication in the long term follow-up following laparoscopic gastric banding~     for morbid obesity.~   "
139080|NCT01234415|"~     The aim of this project is to evaluate the safety and efficacy of the biomaterial made of~     HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this~     biomaterial will avoid the graft sampling and we expect it to be a good substitute to~     support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus,~     that would confirm previous in vitro and in vivo studies.~   "
139081|NCT01234402|"~     An open-label, multicenter, randomized, Phase 2 trial in which patients with unresectable,~     locally advanced or metastatic breast cancer who have been previously treated with~     anthracycline and taxane therapy receive ramucirumab DP or IMC-18F1 administered on an~     every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is~     administered twice a day on Days 1-14 of each cycle). Approximately 150 patients will be~     randomized in a 1:1:1 ratio to either ramucirumab DP or IMC-18F1 in combination with~     capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C).~     Randomization will be stratified by triple-negative receptor status (estrogen~     receptor-negative, progesterone receptor-negative, and human epidermal growth factor~     receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.~      Treatment with the study medication(s) will continue until disease progression, the~     development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient,~     or investigator decision. Capecitabine dose reductions in the setting of significant~     myelosuppression, hand-and-foot syndrome, or diarrhea will be required.~   "
139082|NCT01234389|"~     Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general~     population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma~     and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool~     antigen tests, histology or the Helicobacter urease test (HUT).~      The aim of our study is to access the clinical reliability of a new, electrochemical device~     for rapid H. pylori detection.~   "
139083|NCT01234376|"~     Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of~     the gut at a subcellular resolution. Various studies have addressed the potential of~     endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s~     esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our~     group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic~     esophagitis.~      The purpose of this study is to determine whether endomicroscopy is effective for the in~     vivo diagnosis of eosinophilic esophagitis.~   "
139084|NCT01234363|"~     The purpose of this study is to assess the potential of elastography for noninvasive~     assessment of fibrosis in renal allograft.~   "
139106|NCT01234077|"~     Research study that will test a portable device (CPC M1) that records: body movement; heart~     activity (ECG; snoring; and body position during sleep. The Food and Drug Administration~     (FDA) has not approved this device for use except in a research setting.~      The purposes of this study are to: a) determine if the ECG data collected using the CPC M1~     device is at least as good as the ECG data collected during a diagnostic, in-lab~     polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device~     will provide similar results compared to an in-lab PSG.~   "
139085|NCT01234350|"~     This study is a large observational study set-up to observe how the long-term treatment of~     Firmagon (hormone regulator) compared to another treatment will effect specific conditions~     such as cardiovascular events, changes in bone density, changes in blood sugar levels or~     liver enzyme levels in patients with prostate cancer. Patients will be treated according to~     their routine clinical care and this will not be dictated by the study. As the study is~     observational in nature, the study will collect specific data relating to the 3 specific~     events above. Patients that agree to this study will be followed-up for 5 years. Patient~     data will be collected every 3 months for the first 2 years and every 6 months for the last~     3 yrs.~   "
139086|NCT01234337|"~     The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in~     combination with capecitabine versus capecitabine in combination with placebo in the~     treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who~     are resistant to or have failed prior taxane and an anthracycline or for whom further~     anthracycline therapy is not indicated. After signing consent there can be up to 28 days~     before starting the treatment during which time a number of tests will be carried out which~     will include tumor evaluations and medical history. The following tests and evaluations will~     have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the~     end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a~     complete physical exam and vital signs. Treatment will be given in 21 day cycles with~     sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the~     first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every~     cycle after the first 2 cycles. During the weekly visits the subjects will be check for any~     side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will~     be followed for overall survival.~   "
139087|NCT01234324|"~     That panitumumab in combination with Epirubicin, Cisplatin and Capecitabine (ECX) will~     safely decrease the frequency of pT3/T4 below that of ECX alone in subjects with locally~     advanced adenocarcinoma of the stomach and gastroesophageal junction.~   "
139088|NCT01234311|"~     This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in~     asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of~     tasquinimod on delaying disease progression compared with placebo.~      Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1~     ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day;~     n=800) or Treatment Group B (placebo; n=400).~   "
139089|NCT01234298|"~     To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to~     placebo when given as adjunctive therapy to antipsychotic medication in clinically stable~     adults with persistent predominant negative symptoms of schizophrenia.~   "
139090|NCT01234285|"~     Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue~     hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being~     an anticoagulant, is also a well-known antiinflammatory. The investigators believe that~     unfractionated heparin has the potential to save the lives of septic patients at a~     drastically reduced cost. This is a dose escalation study to determine the safety of~     increasing levels of heparin in this patient population; compare markers of anticoagulation~     and inflammation between treatment groups; and compare clinical outcomes between groups.~   "
139091|NCT01234272|"~     The present study was designed to assess analgesic capacity of intrathecal administration of~     morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared~     to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients~     undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable~     analgesic effect to PCEA in gastrectomy.~   "
139092|NCT01234259|"~     Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis~     and hypodermis.~      Radio-frequency (RF) devices have been used for many years for a variety of surgical~     applications. The energy delivery systems of these established monopolar devices used a~     'conductive coupling' delivery system in which energy is concentrated at the periphery of~     the electrode.~      Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and~     temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides~     and cellulite, the treatments creates enough thermal effect to induce collagen remodeling~     with no ablative thermal damage in the epidermis or dermis.~   "
139093|NCT01234246|"~     In this project the main focus is on assessing sexual functioning and the quality of sexual~     life after the treatment of colorectal cancer in patients and their partners.~      Patients and their partners complete questionnaires concerning sexual functioning, quality~     of life, body image, fatigue, anxiety, depressive symptoms, personality factors, and~     demographic factors. Questionnaires are completed before surgical treatment, 6 weeks, 3~     months, 6 months, and 12 months after diagnosis.~      The results of this prospective study will give insight in 1) the incidence of sexual~     problems and the extent patients with colorectal cancer and their partners are bothered by~     these problems across time, 2) the effect of different treatment modalities on sexual~     functioning, 3) the relation between sexual problems and quality of life, 4) the~     determinants of sexual problems and the quality of sexual life adopting the biopsychosocial~     approach of patients with colorectal cancer who have been treated with surgery, radiation~     and/or chemotherapy, and more specifically to the role of personality and patient factors~     and sexual functioning/the quality of sexual life.~   "
139094|NCT01234233|"~     The investigators want to evaluate the effect of prewarming on the rate of postoperative~     hypothermia and shivering and to compare sublingual versus tympanic temperature assessment~     during the perioperative period in patients.~      Patients will be randomly assigned to 4 groups with different duration of prewarming. Body~     temperature will be recorded regularly by sublingual and tympanic (by thermocouple)~     measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed~     postoperatively.~   "
139107|NCT01234064|"~     This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to~     assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an~     intervention.~   "
139160|NCT01233362|"~     The absence of a boosting response after a 14 day interval with the two-dose regimen of the~     modified killed oral cholera vaccine raises the possibility that a longer dosing interval~     may be required to observe a boost in the immune response. This study will compare the~     immune responses following 14-day and 28-day dosing intervals.~   "
139095|NCT01234220|"~     The AVIS Study is a retrospective multicenter international study that aims to answer a~     series of questions on the use and performance of adrenal venous catheterization (AVS) for~     the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated~     among the centres that are internationally recognized and have published in the field of AVS~     and have agreed to participate in the study.~      The first aim of the AVIS study is to collect summary data on how AVS is being performed~     throughout the world to answer the following questions:~        -  How many AVS studies haw been performed yearly from 2005 to 2010 at each center?~        -  How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of~          adrenal vein rupture been steady or has it changed over the 5 years?~        -  How many centers use bilaterally simultaneous and how many use sequential AVS~          catheterization?~        -  How many radiologists perform AVS at each center?~        -  How many centers use a cosyntropin stimulation during AVS?~        -  What is the percentage of PA patients in whom AVS is performed?~        -  How many centres calculate the selectivity index? What is the minimum cutoff used?~        -  How many centers calculate the lateralization index? What is the minimum cutoff used?~        -  Are the AVS studies that are not bilaterally selective used for diagnosis?~        -  How many centers calculate the controlateral suppression index and what is the minimum~          cutoff used?~        -  What is the cost of AVS for the National Health System or Insurance and for patients?~          The second aim of the study is to calculate the rate of AVS studies that are selective~          and show lateralization of aldosterone excess at each center by applying predefined set~          of criteria for defining selectivity and lateralization. Data on the final diagnosis of~          the PA subtype will be gathered and used as reference to assess the performance of AVS~          using receiver operating characteristic curves analysis and the Youden index to~          determine the optimal cutoffs. A worksheet will need to be completed providing~          information on the following: Demography; Date of AVS;Baseline blood pressure (BP)~          values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol~          concentration in the infra-adrenal inferior vena cava and in the right and left adrenal~          vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy);~          post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or~          RM) and AVS.~   "
139096|NCT01234207|"~     The purpose of this study was to compare objective clinical measures of visual performance~     and subjective measures of satisfaction and preference between standard progressive addition~     lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL~     spectacle.~   "
139097|NCT01234194|"~     The purpose of the study is to determine if the new Composite Variability Index (CVI) is~     capable of detecting changing effect compartment concentrations of remifentanil. In~     addition, it is planed to detect if the change in CVI in response to a standardized painful~     stimulus is dose-dependent.~   "
139098|NCT01234181|"~     The purpose of this study, is to determine the differences of clinical outcomes between~     hypoxic pre-treatment group and control group in bone marrow stem cell transplantation~     (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both~     treatments. Heart failure patients underwent PCI treatment after AMI and with informed~     consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic~     pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected~     into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected;~     echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive~     myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We~     hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be~     reversed in heart failure patients.~   "
139099|NCT01234168|"~     The purpose of the protocol is to to assess subject's overall satisfaction regarding control~     of diarrhea. The study aims to supplement results obtained through clinical trials with data~     obtained from a population of patients receiving treatment with Somatuline Autogel in~     routine practice.~   "
139100|NCT01234155|"~     The purpose of this study is to assess whether 4-months of interval-walking exercise~     training improves glycemic control in individuals with type 2 diabetes mellitus. The effects~     of interval-walking training will be compared to continuous-walking exercise in a~     randomised, controlled trial design. Changes in glycemic control will be examined using oral~     glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin~     sensitivity and secretion will be examined using glucose clamps combined with glucagon-like~     peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).~   "
139101|NCT01234142|"~     This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a~     varenicline patch applied once daily to the skin for 14 days.~   "
139102|NCT01234129|"~     Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.~   "
139103|NCT01234116|"~     Objective: The objective of this study is to determine the safety and tolerability of~     Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care~     workers (HCWs) at Henry Ford Hospital.~      Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in~     combination with Truvada, as assessed by review of completion rates of PEP and also review~     of completed safety data.~   "
139104|NCT01234103|"~     Health damaging (risk) behaviors of young military personnel are reflections of health~     problems facing all young people in the U.S. Military life presents opportunities and~     challenges that may both protect against and place young troops at risk for health damaging~     behaviors. Challenges for maintaining a healthy armed force include high rates of sexually~     transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other~     substances. The common thread through these negative health outcomes is volitional behavior.~     Such behaviors do not only result in illness or injury, but also negatively impact~     performance of military duties and threaten military readiness. Despite military leadership~     in setting standards and policies regarding professional behavior and universal health care~     for preventing and eliminating such negative health outcomes, many health problems remain.~     Building on our previous military research, we will evaluate the effectiveness a~     cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk~     for and acquisition of STIs and UIPs and will seek to reduce a number of their associated~     risk factors including, alcohol misuse, other substance use, and victimization due to IPV in~     male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in~     Fort Jackson, SC.~   "
139105|NCT01234090|"~     This prospective cohort study hypothesizes that an analysis of parallel qualitative and~     quantitative data is necessary to examine the full experience of living with aphasia. It is~     also hypothesized that there are specific factors that act as barriers or facilitators to~     successfully living with aphasia. A unique aspect of the project is the use of the~     Assessment for Living with Aphasia (ALA), a new aphasia friendly measure based on the World~     Health Organization International Classification of Functioning, Disability and Health (WHO~     ICF). Each session will assess written and spoken language, functional communication,~     mobility, Activities of Daily Living (ADL) function, burden of stroke, quality of life, and~     depression.~   "
139154|NCT01233440|"~     The primary objective of the study is to assess the safety of IV administration of rIX-FP.~     Safety will be evaluated by adverse events and laboratory changes over time. The secondary~     objective of the study is to evaluate the pharmacokinetics parameters, following a single~     intravenous dose of rIX-FP.~   "
139108|NCT01234051|"~     1. Goals~             -  The primary goal of this phase II trial is to:~           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin~          in patients with locally advanced or metastatic BTC as first-line therapy~           Secondary goals are to:evaluate the treatment-related toxicities of this combination,~          investigate progression-free survival (PFS) and overall survival (OS) in this~          population~        2. Design~      The proposed clinical trial is an open label, non-comparative, multicenter phase II trial~     according to the two stage testing design by Simon.22~   "
139109|NCT01234038|"~     The purpose of this study is to examine the overall survival of patients with Stage IV~     non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with~     carboplatin and paclitaxel.~   "
139110|NCT01234025|"~     The purpose of this study is to examine the safety, tolerability and progression-free~     survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in~     combination with docetaxel and prednisone.~   "
139111|NCT01234012|"~     The purpose of this study is assess the safety of administering repeated doses of IMF-001, a~     vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is~     therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat~     patients with NY-ESO-1 positive cancers.~   "
139112|NCT01233999|"~     The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is~     a painful condition in which cold surroundings or stressful events trigger pain, a cold~     sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think~     that RP results from problems with some of the components of the blood vessels, surrounding~     nerves, and some of the circulating messengers in the bloodstream. Although there are many~     different medicines that are currently used to treat RP, the investigators have not yet~     found a cure for severe cases of this condition. Furthermore, the investigators have found~     few medicines that show consistent healing of the ulcers that may be associated with RP.~     Some of the treatments include medicines that are used to treat high blood pressure known as~     calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin~     have also been used to treat RP.~      In this study, the investigators will investigate a new treatment for RP known as Botulinum~     toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been~     approved by the government for the treatment of several other conditions including but not~     limited to: excessive sweating, neck pain associated with a condition known as cervical~     dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a~     condition known as strabismus in which the eyes are not in alignment with one another.~      This study will aim to greatly improve the quality of life and pain associated with RP.~     Previous studies also support the chance that Botulinum toxin will help to heal some of the~     ulcers associated with RP. Although there is no current standard of care, many of the~     patients in the study will have already failed or are unable to tolerate commonly used~     treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and~     anticoagulants. If the patient chooses to participate in the study, he/she will be randomly~     assigned to receive an injection with Botulinum toxin in either the left or right hand. The~     other hand will be injected with saline solution. Neither the patient nor the physician or~     research personnel seen in follow-up will know which hand is injected with Botulinum toxin.~   "
139113|NCT01233986|"~     The purpose of this study is to evaluate whether the serum apoB48 level is associated with~     atherosclerotic ischemic stroke.~   "
139114|NCT01233973|"~     To compare the decision making of elderly subjects having a verbal advance care planning~     discussion compared to subjects using a video.~   "
139115|NCT01233960|"~     To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol~     603 to evaluate the safety in subjects with active Crohn's disease who are resistant to~     standard Crohn's disease therapies.~   "
139116|NCT01233947|"~     AFP464 is an investigational agent which may be effective in the treatment of cancer. The~     purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer~     patients.~   "
139117|NCT01233934|"~     Insect bite related symptoms (pruritus and papules) are caused by the release of histamine~     by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these~     symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation~     approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the~     ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority~     of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the~     standard preparation (1% cream) for the relief of insect bite related symptoms and to~     demonstrate the safety of both preparations.~   "
139118|NCT01233921|"~     RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease~     caused by donor stem cell transplant.~      PURPOSE: This randomized clinical trial studies palifermin in preventing chronic~     graft-versus-host disease in patients who have undergone donor stem cell transplant for~     hematologic cancer~   "
139119|NCT01233908|"~     To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients that~     underwent surgery for primary rhegmatogenous retinal detachment (RRD) and to determine~     variables associated with the disorder.~      Design: Consecutive prospective observational study.~   "
139120|NCT01233895|"~     Primary Objectives:~      Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on~     pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth~     factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in~     patients with recurrent, refractory multiple myeloma (MM).~      Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the~     recommended dose of Velcade®.~      Secondary Objectives :~      Study Part 1:~        -  To assess the safety profile: type, incidence and intensity of drug related adverse~          events (AEs)~        -  To assess the biological activity of AVE1642 (saturation of the receptors and~          down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells~          (PBMC) and granulocytes~        -  To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1~          system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells~          when technically possible~        -  To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3~        -  To assess clinical efficacy (complete response [CR], partial response [PR], minimal~          response [MR] and stabilization) based on the European group for Blood and Marrow~          Transplantation (EBMT) criteria, when possible~        -  To assess potential immunogenicity by detection of human antihumanized antibodies~          (HAHA) anti-AVE1642~      Study Part 2:~        -  To detect any PK or PD interaction between AVE1642 and Velcade®~        -  To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria~          when appropriate~        -  To assess biological activity of AVE1642 in combination with Velcade® on malignant~          plasma cells collected from bone marrow aspirates: saturation and down-regulation of~          the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization~          pathway of the IGF-1 system (pAkt, pErk) when feasible~        -  To detect immunogenicity reaction (HAHA)~        -  To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be~          non biologically active~   "
139121|NCT01233882|"~     This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with~     renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe~     renal impairment and subjects with normal renal function will be enrolled. Subjects with~     mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1~     suggest a substantial difference in PK profiles between subjects with severe renal~     impairment and subjects with normal renal function.~   "
139122|NCT01233869|"~     This purpose of this study is to determine if bosutinib reduces the rate of kidney~     enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering~     the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than~     or equal to 60 mL/min/1.73m2.~   "
139123|NCT01233856|"~     Type of study:~      This study is a prospective, randomized, placebo controlled, double blind trial comparing~     the response to treatment in children with a diagnosis of ADHD treated with stimulants and~     placebo vs. children with a diagnosis of ADHD on stimulants plus Omega-3 fatty acids.~      Hypothesis:~      The use of Lovaza (prescription Omega-3 fatty acids) as an adjunctive therapy for children~     with adequate diagnosis of ADHD on treatment with stimulants will not improve their~     functioning and behavior measured by the Parent and Teacher Conner's Rating Scale and an~     improvement in their Clinical Global Impression.~      Method:~      A total of 30-150 patients between ages of 6 and 15 y/o with diagnosis of ADHD according to~     the DSM-IV-TR and on current treatment with stimulants recruited from CAOS-Maimonides~     Medical Center and the Developmental Center will be evaluated by a child psychiatrist or a~     resident under supervision of a child psychiatrist to make sure that the diagnosis is~     correct. Every child will have a Conners Rating Scale filled out by the parents and teachers~     on admission to the study. The evaluators will also fill out a Clinical Global Impression~     Scale (CGI). Patients will be divided in two groups, one will consist of 15 children taking~     usual dose of stimulants plus placebo and the other group, 15 children will receive the~     usual dose of stimulant plus Lovaza at a dose of 1800mg daily. Both groups will be treated~     for 8 weeks. Patients will be re-evaluated by investigators on week 2,4,6 and 8 of the study~     and on each evaluation the parents and teachers will fill out a Conner's rating scale.~     Ratings of the Conner's scales filled out for each patient will be analyzed and compared to~     the initial evaluation after week 8. Evaluators will also obtain a CGI score for each visit.~     Patients that improve will be taken off the stimulants and will continue further treatment~     with the adjunctive therapy for a total of 4 more weeks, during this period of time, they~     will be re-evaluated on weeks 9,10 and 12 and Conner's Scales will also be filled out by~     parents.~      Patients who do not improve will be switched to the opposite treatment modality and will be~     evaluated on weeks 9,10 and 12 also having Conner's Scales filled out by their parents. If~     any of the patients in this group improve (after the switch) they will be taken off~     stimulants and they will be evaluated on weeks 13,14 and 16 of the study arm.~      The idea is to conduct the study and obtain information about prescription Omega-3 fatty~     acids as an adjunct to stimulants for patients with ADHD, as several publications have been~     done in the past suggesting it can be beneficial, but there have not been any conclusions on~     whether the treatment is beneficial or not for this population.~   "
139124|NCT01233843|"~     The purpose of this study is to demonstrate that induction chemotherapy followed by~     radiation therapy plus Cetuximab will give better results than the validated treatment~     (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.~   "
139125|NCT01233830|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423~     in young and elderly healthy Japanese volunteers.~   "
139126|NCT01233817|"~     The proposed feasibility study is necessary to test if children and young adults will~     participate in and adhere to a 12-week, home-based, supervised progressive strength training~     exercise program and to obtain preliminary data that will subsequently allow us to determine~     the safety and impact of strength training in spinal muscular atrophy. Our pilot study will~     address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation~     in and adherence to a 12-week home-based, supervised, progressive strength training exercise~     program in children and young adults aged 5-21 years with SMA types II and III; (2)~     Determine the safety and tolerability of progressive strength training in a pilot study~     sample of children and young adults with SMA types II and III; and (3) Determine candidate~     outcome measures.~   "
139127|NCT01233804|"~     The purpose of this study is to compare methods for consenting (opting in vs opting out) on~     influenza vaccine uptake rate in pregnant women. This study is designed to learn about the~     impact of influenza vaccination in pregnant women. This study will help gather knowledge~     about influenza vaccine side effects (if given) and whether the vaccine reduces the number~     of respiratory infection in mothers and their infants.~   "
139128|NCT01233791|"~     The purpose of this study is to determine whether vaginal diazepam suppositories are an~     effective treatment of high tone pelvic floor dysfunction.~   "
139129|NCT01233778|"~     The objectives of this study are to examine how the consumption of treatment oils (including~     canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower~     oil) influence endothelial function, inflammation, oxidation, body composition, and plasma~     lipoprotein characterization.~   "
139130|NCT01233765|"~     Recent scientific evidence suggests that the main defence cell of the body (neutrophil)~     behaves in a different manner in patients with gum disease; namely how they interact with~     bacteria and their role in defence systems of the body. This study proposes to examine these~     responses in periodontitis patients and healthy controls.~      The proposed study will include patients undergoing periodontal (gum) treatment who will be~     matched to periodontally healthy controls. Blood, gingival crevicular (gum) fluid and~     clinical measures will be collected both pre- and post-therapy to measure differences in~     cell behaviour both before, and following routine therapy.~      Blood samples will be used to isolate peripheral blood neutrophils prior to analysis of~     their responses to different bacterial stimuli including oxygen radical, cytokine and~     extracellular trap release. Gingival Crevicular Fluid samples will be used to measure~     different biochemical markers that result from the production of Neutrophil Extracellular~     Traps (NETs). Routine clinical measures will be taken both pre- and post-therapy as a~     measure of treatment response.~      Patient volunteers undergoing treatment will be asked to donate a total of four small~     samples of tissue from the gums whilst they are already anaesthetised for routine treatment.~     These will be approximately the size of a needle head (2mm2mm) and used to examine NET~     formation within the tissues and related processes. This will provide novel in-vivo data~     regarding this recently discovered method of neutrophil defence in innate immunity.~      This proposal represents a novel study aimed at improving our current understanding of why~     inflammatory periodontitis develops in some patients but not others, as well as providing~     pointers to causal/noncausal relationships between periodontitis and important systemic~     conditions such as diabetes and rheumatoid arthritis.~      Ultimately, novel treatment approaches and primary prevention (for periodontitis) or~     secondary prevention (for systemic disease) strategies may emerge.~   "
139131|NCT01233752|"~     Identification of the genetic polymorphisms that could be correlated either with a better~     clinical response or with a major predisposition of patients to develop tolerance and/or~     side effects to the treatment with morphine.~   "
139132|NCT01233739|"~     Patients who present rhizarthrosis diagnostic will be randomized to be treated with~     chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with~     objective and subjective indicators of pain and sensibility.~   "
139133|NCT01233726|"~     The aim of the study is to evaluate the beneficial effects of the administration of a~     complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in~     patients with stress hyperglycemia(T-Diet Plus Diabet IR).~      The main objective of this project is to evaluate blood glucose metabolic control, insulin~     requirements, insulin action resistance, lipid profile and to reduce infectious~     complications on mechanical ventilation ICU (intensive care unit) patients after the~     administration of a complete diet enriched in MUFA and slow absorption carbohydrates,~     without fructose.~   "
139134|NCT01233713|"~     The purpose of this multi-center randomized trial is to identify any differences in the~     complication rates of patients undergoing Hartmann's (end colostomy) versus Primary~     Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including~     the stoma reversal operation).~   "
139135|NCT01233700|"~     The purpose of this study is to evaluate the potential effectiveness of a psychosocial~     intervention based on the principles of motivational interviewing. The novel intervention~     will assist living donor candidates to think through any remaining concerns or questions~     that they may have about living donation. If the intervention is effective, it may help to~     prevent post-donation problems related to psychological and health outcomes.~   "
139155|NCT01233427|"~     Characterize a population-based sample of first-time expectant mothers with regards to~     maternal metabolic health and their infant feeding experience.~   "
139136|NCT01233687|"~     This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with~     advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC~     that has been treated with at least one and a maximum of two prior chemotherapy regimens.~     The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling~     21-45 subjects.~      The Phase I part of the study is designed to determine how safest the combination of AMG 102~     and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to~     determine whether the combination of AMG102 and erlotinib works enough to warrant further~     interest in this combination.~   "
139137|NCT01233674|"~     This study evaluates images obtained from a standard clinical cardiac MRI for evidence of~     fibrosis.~   "
139138|NCT01233661|"~     We intend to examine the effects of temporary elevation of atrial wall stress by shortening~     of the atrioventricular delay in patients with dual-chamber pacemakers.~   "
139139|NCT01233648|"~     This study is being done to find out if controlling rate or controlling rhythm is better for~     heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device~     and AV node ablation as part of their clinical care will be followed for one year. One group~     will have their heart rate controlled by the ICD and AVN ablation alone and the second group~     will be treated with the ICD, AVN ablation and standard medical therapies to restore the~     heart's normal rhythm. The study doctors will compare the information collected from all of~     the subjects in this study to see if treating rate or treating rhythm is better in patients~     with heart failure and AF, resulting in a better quality of life.~   "
139140|NCT01233635|"~     In the present application, we propose to refine and extend current insight into AAF~     mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE~     genotype, and their interaction in secondary AF prevention. We have 3 specific aims:~        1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.~        2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS~          inhibition therapy is higher among patients with the D allele.~        3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing~          AF recurrence in patients with the DD genotype than in those with DI or II genotypes.~   "
139141|NCT01233622|"~     This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy~     to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).~   "
139142|NCT01233609|"~     The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both~     slow the progression of visual function loss and/or to restore visual function in patients~     with Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability~     information.~   "
139143|NCT01233596|"~     The aim of the study was to compare the success rate of monocanalicular intubation versus~     bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children~     aged between 10 and 36 months.~   "
139144|NCT01233583|"~     The aim of this study is to understand which therapies will suppress effector cells and~     promote regulatory T cells and To test whether patients with a better response to therapy~     and longer psoriasis-free periods develop a higher numerical ratio of regulatory to~     effectors T-cells and/or regulatory cells more able to suppress the effectors.~   "
139145|NCT01233570|"~     An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns~     disease~   "
139146|NCT01233557|"~     Biomarkers of bone resorption will be measured in the blood of patients with bone metastases~     from prostate cancer during the course of their illness. Changes in these biomarkers will be~     correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and~     the response and/or progression of their cancer. It is hoped that serial measurement of~     these biomarkers may allow therapeutic monitoring in the future with successful~     individualisation of bisphosphonate therapy for metastatic prostate cancer.~   "
139147|NCT01233544|"~     This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation~     (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma~     liver metastases.~      Primary end point is local progression free survival.~   "
139148|NCT01233531|"~     Cash transfers to young women for staying in school and its effect on acquiring HIV~   "
139149|NCT01233518|"~     This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and~     Asian centers designed to determine the diagnostic performance of CT-FLOW (the~     investigational technology) by coronary computed tomographic angiography (CCTA) for~     non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to~     direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a~     reference standard.~   "
139150|NCT01233505|"~     This phase I trial is studying the side effects and the best dose of veliparib when given~     together with capecitabine and oxaliplatin in treating patients with advanced solid tumors.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor~     cells.~   "
139151|NCT01233492|"~     RATIONALE: Giving boron phenylalanine in different ways and measuring it in tissue in~     patients with glioblastoma multiforme may help in planning better radiation therapy, such as~     boron neutron capture therapy, for patients in the future.~      PURPOSE: This phase I trial is studying the side effects, best dose boron phenylalanine, and~     best way of giving it with or without mannitol in treating patients with glioblastoma~     multiforme.~   "
139152|NCT01233479|"~     RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation~     therapy and chemotherapy may help doctors learn more about the effects of this treatment on~     cells. It may also help doctors understand how well patients respond to treatment.~      PURPOSE: This research study is studying biomarkers in blood samples from young patients~     with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.~   "
139153|NCT01233453|"~     This is a prospective, randomized, multi center study. Approximately 2700 patients will be~     entered in the study and will be randomized on a 2:1 basis. Patients who meet the~     eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime®~     or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for~     5 years.~   "
139161|NCT01233349|"~     Preparations that bind to nutritional fat and inhibit its absorption could be decisively~     meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble~     fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness~     after eating. Such effects are supposed to facilitate adherence to energy-restricted diets.~     The medical device to be investigated contains a patented formula of fibre complex having a~     high ability to bind to dietary fat.~      Therefore, the rationale for this study is to confirm that Litramineʼs proven fat binding~     capacity to increase fat excretion and modulate the feeling of satiety will translate into~     measurable reduction in body weight. A double blind, randomized, placebocontrolled design~     has been chosen to assess the efficacy and safety of Litramine in overweight and obese~     subjects on a energy-restricted diet.~   "
139162|NCT01233336|"~     This is the continuation of previous study (registration number: NCT00844987) which revealed~     that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and~     prognostic factor for post myocardial infarction (MI) cardiovascular events presence in~     long-term follow-up. Due to potentially very important implication of the results of~     previous study it was decided to continue research of HGF in patients with MI. Now, is~     scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed~     just after admission to hospital, 1h and 24h later and before discharge. Two follow-up~     visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month~     visit the echocardiography examination will be performed. The composite primary endpoint~     consists of cardiovascular events observed during hospital course and in long~     term-follow-up.~   "
139163|NCT01233323|"~     The purpose of this study is to collect sensor data from patients with implanted cardiac~     resynchronization devices who exhibit phrenic nerve stimulation.~   "
139164|NCT01233310|"~     Study Hypothesis:~      It is estimated that by re-programming some of the PillCam COLON2 system parameters it can~     serve as tool for visualizing both small bowel and colon. As such, the system may be~     utilized in CD patients for monitoring mucosal healing.~      Primary objectives:~      To evaluate two different video output methods in the visualization of the SB and colon in~     CD patients~      Secondary objectives:~        -  Evaluate the level of agreement between PillCam system and ileocolonoscopy on the~          assessment of CD findings.~        -  Evaluate the effectiveness of PillCam regimen in CD patients~      Inclusion criteria~        -  Patient is 18 years of age and above~        -  Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by~          endoscopical, histopathological and/or radiological parameters~        -  Patients' CDAI >150.~        -  Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's~          disease~        -  Proven patency by Agile capsule or another approach deemed clinically acceptable by the~          investigator, e.g. CT enterography, performed within the 3 months prior to enrollment~        -  Patient is able and agrees to sign the Informed Consent Form~      Exclusion criteria~        -  Patient has dysphagia~        -  Patient has congestive heart failure~        -  Patient has renal insufficiency~        -  Patient has cirrhosis~        -  Patient is known or is suspected to suffer from intestinal obstruction~        -  Patient has known previous stricture/obstruction of the SB or colon~        -  Patient has taken NSAID medications less than one month before enrollment~        -  Patient suffers from hypertension and is taking one or more of the following~          medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II~          blockers~        -  Chronic use of laxatives~        -  Patient has a cardiac pacemakers or other implanted electro medical devices.~        -  Women who are either pregnant or nursing at the time of screening, who intend to be~          during the study period, or are of child-bearing potential and do not practice~          medically acceptable methods of contraception.~        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the~          capsule.~        -  Patient has had prior abdominal surgery of the gastrointestinal tract other than~          uncomplicated procedures that would be unlikely to lead to bowel obstruction based on~          the clinical judgment of the investigator.~        -  Patient has any condition, which precludes compliance with study and/or device~          instructions.~        -  Patient suffers from life threatening conditions~        -  Patient is currently participating in another clinical study~        -  Patient has known slow gastric emptying time~        -  Patient is allergic or contraindicated to any of the study medications~   "
139165|NCT01233297|"~     Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to~     viral infection. The current study will examine whether treatment of asthmatic exacerbations~     with macrolide antibiotics - in the abscence of clear clinical bacterial infection which~     would in any case precipitate antibiotic treatment - has an effect on either the particular~     episode, or subsequently. Macrolide antibiotics are chosen for ease of administration~     ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.~   "
139166|NCT01233284|"~     Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25~     µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with~     moderate persistent asthma who are still symptomatic despite regular maintenance therapy~     with inhaled corticosteroids (ICS).~      The data collected in the present trial will provide useful information to health care~     providers and patients regarding the efficacy and safety of a once daily inhalation of three~     different doses of tiotropium solution delivered by the Respimat® inhaler in addition to~     inhaled corticosteroids in the treatment of not fully controlled moderate asthma in~     comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD~     patients. However, there is currently no PK data available for the 3 doses of tiotropium~     being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once~     daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours~     in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients.~     Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a~     once daily dosing of tiotropium inhalation solution is effective and safe in the treatment~     of moderate persistent asthma.~   "
139167|NCT01233271|"~     Hyperglycemia is common in critically ill patients and associated with an adverse outcome.~     Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of~     the intensive care unit staff difficulties were experienced in achieving efficient and safe~     glucose control. A fully automated algorithm may help to overcome some of these limitations~     by excluding intuitive interventions and integrating relevant clinical data in the~     decision-making process. Space GlucoseControl (TGC system) is a decision support system~     which helps to achieve safe and reliable blood glucose control in the desired ranges.~     Information on parenteral and enteral nutrition is automatically integrated into the~     calculations. The primary objective of the current study is to investigate the performance~     and usability of the Space TGC system for glucose control over an extended glucose control~     range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.~   "
139168|NCT01233258|"~     The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy~     with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe~     Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand~     treatment.~   "
139169|NCT01233245|"~     This is an observational survey to assess the factors that influence adherence to Betaferon~     therapy in multiple sclerosis patients using elements of the BetaPlus support program,~     including the nurse support and auto-injectors. The patients were evaluated under normal~     clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping~     processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.~   "
139171|NCT01233219|"~     Identification of the genetic polymorphisms that could be correlated either with a better~     clinical response or with a major predisposition of patients to develop tolerance and/or~     side effects to the treatment with morphine.~   "
139172|NCT01233206|"~     The use of metformin pre-treatment and co-administration was recently proposed in infertile~     women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.~      Data from meta-analyses showed that metformin administration significantly reduced the~     stimulation length and the total dose of gonadotropins used in PCOS women undergoing~     gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in~     IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation~     syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.~      The metformin regulating effect on the ovarian response was also observed in a randomized~     controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving~     gonadotropins for mono-ovulation induction. In particular, metformin increased the~     mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used,~     while it reduced the number of dominant follicles and the estradiol (E2) levels.~      The aim of the present study was to evaluate the effect of metformin administration in high~     responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.~   "
139173|NCT01233193|"~     The purpose of the study is to test if a Pharmacist Intervention Program with home blood~     pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure~     levels in hypertensive patients under pharmacological treatment, compared to those who~     receive usual care in a community pharmacy setting.~   "
139174|NCT01233180|"~     Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the~     treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a~     round-edged instrument until small petechiae appear. This so called sha, considered as the~     removal of blood stasis by traditional practitioners, will fade within a few days. Normally,~     this treatment is not considered as painful, but as relaxing and easing tense muscles.~      In this study, the investigators will investigate the effectivity of Gua Sha massage in~     treating chronic neck pain. The investigators will research effects on subjective pain~     intensity, neck pain specific disability and haptic perception.~   "
139175|NCT01233167|"~     The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone~     versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our~     subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent~     implantation.~   "
139176|NCT01233154|"~     Various studies in animal and humans have shown a potential beneficial effect of probiotics~     consumption on allergy. However few studies exist that document their efficacy for upper~     airways allergies such as allergic rhinitis. The objective of this study is to investigate~     the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics~     (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed~     out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a~     randomized, double-blind study, based on two 4-weeks cross-over periods of product~     consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical~     parameters of NPT as well as systemic and nasal immunological markers are compared before~     and after each treatment.~   "
139177|NCT01233141|"~     The rationale of this study is to establish a registry to detect and follow patients with~     CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence,~     prevalence, and actual outcome of CLI patients in a real world setting and should serve as a~     tool for the evaluation of medical, endovascular and surgical interventions. It will help~     determining the prognosis of individual patients and have impact on economic and political~     decisions in Vienna concerning this disease and the related costs.~   "
139178|NCT01233128|"~     This study is to investigate whether there is an association of the LOC387715/HTRA1 and~     vascular endothelial growth factor polymorphism with response to treatment with intravitreal~     ranibizumab injections for patients with polypoidal choroidal vasculopathy.~   "
139179|NCT01233115|"~     This study is to investigate whether there is an association of the LOC387715/HTRA1 variants~     with response to treatment with combined photodynamic therapy and intravitreal bevacizumab~     for patients with polypoidal choroidal vasculopathy.~   "
139180|NCT01233102|"~     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem~     cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be~     monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total~     bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at~     pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for~     End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.~   "
139181|NCT01233089|"~     The purpose of this three-month study is to compare the quality of life and ease of fit~     among children wearing investigational single-vision contact lenses, commercially marketed~     single-vision contact lenses, and commercially marketed multifocal contact lenses.~   "
139182|NCT01233076|"~     The purpose of this study is to evaluate the performance of two commercially marketed daily~     disposable contact lenses in a population of daily disposable contact lens wearers.~   "
139183|NCT01233063|"~     The trial will test whether the Alive email-delivered health behavior program can improve~     subjects' physical activity, fruits and vegetables and saturated/trans fats and added~     sugars.~   "
139194|NCT01232920|"~     The proposed study is a masked trial, with stratified block randomization by site, designed~     to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as~     first-line steroid-sparing treatment for patients with non-infectious uveitis requiring~     corticosteroid-sparing therapy.~      One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will~     be randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind~     Eye Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6~     months after enrollment or until treatment failure. The investigators hypothesize that the~     proportion achieving corticosteroid-sparing success at 6 months for patients taking~     mycophenolate mofetil will be improved in comparison with patients taking methotrexate.~   "
139224|NCT01232530|"~     This is a phase IV open label study assessing the safety and effectiveness of artemisinin~     derivatives-based combination therapy (ACT) when used on a large scale and under real life~     conditions.~   "
139184|NCT01233050|"~     Surgical site infections (SSI) are one of the most common complications in the~     post-operative patient, and the second most common health care associated infection overall.~     It is estimated that there are between 500 thousand and 1.1 million surgical site infections~     in the United States each year. Given the magnitude of the problem, prevention of surgical~     site infections is a major goal of peri-operative care. However, skin preparation prior to~     surgery has not been as rigorously examined. The primary objective of this study is to~     compare the efficacy of two FDA approved, popular peri-operative skin preparations 2%~     chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine]~     / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and~     female patients, age 18 years and older undergoing elective colorectal surgical procedures~     involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible~     patients will be assessed at regular intervals for SSI and characterization of bacterial~     pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days~     postoperatively.~   "
139185|NCT01233037|"~     This is a non-randomized feasibility study of endothelial function, exercise capacity, and~     outcome following pre-left ventricular assist device (LVAD)therapy and cardiac transplant.~      The study period will be 5 years, with 20 patients to be enrolled. The investigators~     anticipate that 15 patients will survive to complete the one year follow up period.(the~     published survival rate of LVAD is 75% in one year). 10 patients are anticipated to undergo~     cardiac transplant within 3 years of initial enrollment and they are followed until their~     2nd annual post transplant invasive evaluation.~      Markers of endothelial function will be studied to permit comparison with selected clinical~     outcomes. The hypothesis is that the endothelial functions will be altered after~     implantation of LVAD then before its implantation, both acutely and chronically, and this~     may affect the exercise capacity, quality of life and occurrence of cardiac allograft~     vasculopathy post cardiac transplantation.~   "
139186|NCT01233024|"~     Studies have found a relationship between dietary fiber consumption and body weight~     regulation. This relationship may stem from enhanced satiety through fermentation of certain~     fibers in the large intestine.~      The objective of this study is to determine and compare satiety ratings, changes in food~     intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble~     corn fiber, and resistant starch.~   "
139187|NCT01233011|"~     The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically~     engineered for use both as a standalone laryngeal mask airway (LMA) and as a rescue device~     or Plan B device in the event of a difficult airway. As with some other types of LMA, it~     is then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly~     or mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will~     be a prospective observational study of the Air-Q® ILA's performance.~   "
139188|NCT01232998|"~     The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza~     hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the~     quality services in the department based on the research result.~   "
139189|NCT01232985|"~     The purpose of this study is to find out if investigational device, RD047-26, is safe and~     useful for the treatment of mild to moderate atopic dermatitis.~   "
139190|NCT01232972|"~     The purpose of this investigation is to offer the opportunity for young women to~     cryopreserve (freeze) their oocytes (eggs) for use with IVF at a later point in time.~   "
139191|NCT01232959|"~     Today there are three different ways to remove a gallbladder with gallstones. Surgeons can~     remove the gallbladder through small incisions in the abdomen. This is called laparoscopic~     cholecystectomy. It is the current standard. It has replaced traditional open gallbladder~     surgery. Open gallbladder surgery is done with a large incision. A new way of removing the~     gallbladder in women is through the vagina. This is called transvaginal cholecystectomy.~     This study is being done to see if removing the gallbladder through the vagina will work for~     patients at Mayo Clinic Rochester. This is the first step of this research to test the~     procedure. In the future, other studies will examine the potential for less scarring and~     reduced pain. In this study the investigators will still make small incisions in the~     abdomen, they will be smaller than the standard procedure but you will still have some scars~     on your abdomen.~      Some very early research reports say that some patients may have less pain with the~     transvaginal approach; however, the investigators do not know if the transvaginal route will~     have any effect on your overall health and quality of life.~      This study will evaluate:~        -  Effectiveness of the surgery: ability to remove the gallbladder safely~        -  Effect of the operation on your body: change in pulse and blood pressure during the~          surgery, level of inflammation markers in your blood before and after the surgery~        -  Recovery from surgery in the hospital: how much pain you have, how much pain medication~          you need, how long you need to stay in the hospital, or nature of any surgical~          complications (problems)~        -  Overall recovery from surgery: general quality of life, abdominal symptoms~      What is the new type of surgery?~      The new type of surgery is called transvaginal cholecystectomy:~      A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is~     inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A~     very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps~     the surgeons to remove your gallbladder through the vagina. The procedure to separate your~     gallbladder from your body will be assisted by instruments placed through your abdomen and~     instruments placed in your vagina. The surgeon will remove the gallbladder by passing it~     though your vagina.~   "
139192|NCT01232946|"~     The investigators will test the hypothesis that effects of liraglutide plus insulin detemir~     on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type~     2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or~     with oral antidiabetic agents will be randomly assigned to one of three treatment groups:~     insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All~     subjects will undergo an initial standardization of background treatment to metformin 2000~     mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8~     mg/day (once daily each morning, tapering up according to label instructions) and/or detemir~     (administered twice daily, initially at 10 units per day then titrated to achieve fasting~     morning glucose readings below 130 mg/dL). PET measurements of myocardial fuel selection~     will take place at the end of this treatment period, under fasting conditions in the morning~     following that day's treatment injection(s).~   "
139193|NCT01232933|"~     Subjects meeting study requirements will be consented and have their PICC catheter placed~     using navigational technology and the tip placement confirmed with radiographic imaging.~   "
139265|NCT01231997|"~     This study is designed to assess the effect of renal impairment on the pharmacokinetics,~     safety and tolerability of udenafil in subjects with renal impairment compared to healthy~     subjects.~   "
139381|NCT01230476|"~     Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent~     cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma~     cells with high EGFR protein expression, may enhance the effectiveness of radiation and~     result in better tumour control. This study investigates the addition of 2 cycles of~     cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent~     with radiation, for treatment of locally advanced nasopharyngeal carcinoma.~   "
139195|NCT01232907|"~     1. Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment~          of fatigue in persons with spinal cord injury (SCI).~        2. Hypothesis: Similar to previous research in disabled and aging populations, the~          investigators hypothesize that treatment with L-Carnitine will result in a significant~          improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on~          the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see~          an effect after approximately three weeks of treatment.~      As secondary outcomes, the investigators expect to see positive changes in the Centre for~     Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual~     Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of~     L-Carnitine directly on pain and depression, and the effects of the potential decrease in~     fatigue.~   "
139196|NCT01232894|"~     In this 12-week study, patients were randomized to either open-label indacaterol or standard~     of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were~     assessed.~   "
139197|NCT01232881|"~     This is a tumor and serum collection study for patients with advanced breast cancer~     receiving treatment with lonafarnib.~   "
139198|NCT01232868|"~     Vaccination is the most effective way of preventing infectious diseases. Despite the success~     of vaccines in general, vaccines induce diminished antibody responses and lower protection~     in the elderly in particular. This could be explained by a defect in the early responses of~     an ageing immune system. A better understanding of the basic immunological mechanisms that~     mediate vaccine efficacy is incomplete. Such information is critical and could greatly~     decrease both the cost and the time to new vaccine development particularly for the~     geriatric population.~      In this trial, the investigators will study the immunologic differences of an FDA approved~     licensed influenza vaccine between a younger and an older group. Twenty two healthy~     volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65~     will be enrolled in the study. Each participant in the study will be given one flu shot.~     Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen~     days, as well as one month and six months after vaccination. Throughout the duration of the~     study, the participants will be monitored for safety.~   "
139199|NCT01232855|"~     RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     acute promyelocytic leukemia.~   "
139200|NCT01232842|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     acute myeloid leukemia.~   "
139201|NCT01232829|"~     This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway~     inhibitor RO4929097) works in treating patients with previously treated metastatic~     pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes~     needed for cell growth.~   "
139202|NCT01232816|"~     Delayed graft function (DGF) increases risk of acute rejection after kidney transplantation~     (KTx). Interleukin-6, which is produced in DGF, is critical in directing naive T helper~     cells differentiation towards T helper 17 (Th17) and away from regulatory T (Treg) cells.~     The investigators hypothesize there is an increase in Th17 and a decrease in Treg expression~     in KTx recipients with DGF compared to those without, leading to immunologic consequences.~     The investigators will test their hypothesis by measuring in both groups expression of Th17,~     Treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid,~     and correlating these results with immunologic events.~   "
139203|NCT01232803|"~     MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study~     of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied~     rectally. The primary objective of this study is to assess the safety of vaginally~     formulated tenofovir 1% gel when applied rectally.~      After completing screening and baseline evaluation, eligible participants will be randomized~     to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also~     include a no treatment arm. There will be 15 participants in each arm.~      Participants will return to the clinic, where they will self-administer a single dose of the~     study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal~     biopsy specimens will be obtained. After a one-week recovery period, participants will~     return to the clinic for assessment. If no significant adverse events (AEs) are reported~     they will begin to self-administer once-daily outpatient doses of the study gel for 7 days.~     Participants will return to clinic for evaluation and specimen collection after completion~     of 7 days of daily dosing.~   "
139204|NCT01232790|"~     The purpose of this study is to evaluate the effects of the amino acid supplement~     N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons~     with a diagnosis of schizophrenia.~   "
139205|NCT01232777|"~     The purpose of this study is to determine whether a single intravitreal (into the gel of the~     eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with~     standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP)~     diagnosed at 30-36 weeks gestational age.~   "
139214|NCT01232660|"~     The purpose of the study is to examine the effects of adding a drug called~     hydroxychloroquine, usually used to treat rheumatoid arthritis, to patients' usual~     antiretroviral combination. HIV causes activation of some parts of the immune system and~     this immune activation may persist despite effective antiretroviral therapy. Ongoing~     activation may be responsible for poor CD4 rise on antiretroviral therapy and for some~     HIV-related complications. Drugs like hydroxychloroquine work by inhibiting immune~     activation.~      The study will primarily investigate the effect of adding this medication on immunological~     parameters (particularly CD4 count), on other safety parameters (such as cholesterol),~     patients' side effects and viral load.~      If you decide to take part, the duration of your involvement in the study will be 24 weeks~     plus two screening visits up to 84 days prior to the start of the study and a follow up~     visit.~   "
139298|NCT01231568|"~     The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of~     150 mg of GSK2118436, as well as the effects of particle size on the relative~     bioavailability of GSK2118436.~   "
139206|NCT01232764|"~     The purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary~     wound care teams (MDTs) vs. 'usual' care teams in Long Term Care (LTC) facilities in Ontario~     for the treatment of pressure ulcers. LTC facilities with more than 100 beds that are within~     a 100 km distance from St. Mikes and have a problem with pressure ulcers will be asked to~     participate. A total of 10 LTC facilities will be randomly selected (i.e. selected by~     chance) from those that agree to participate.~      The 'enhanced' MDT will be an Advance Practice Nurse(APN) with expertise in wound care who~     has direct access to the wound care team at St. Mikes. This APN will develop treatment plans~     in consultation with facility staff, providing targeted pressure ulcer treatment education~     on an ongoing, case by case basis. Care is supported by telemedicine with the use of digital~     photography and online communication between members of the care team.~      This study is a stepped wedge randomized trial, meaning LTC facilities are assigned to a~     start date for this study totally by chance. Changes in healing rates, wound related pain,~     cost, number of new pressure ulcers, and number of wounds healed will be measured before,~     and after the APN is introduced to facilities. In order to gain more insight into how people~     felt about this model of care, interviews will be held with individuals and groups of staff~     at 5 randomly selected facilities before, during, and after the study has been completed.~   "
139207|NCT01232751|"~     Alleged benefits experienced by the consumption of soy in Asian countries have been~     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones~     are believed to relieve menopausal symptoms and are therefore often consumed in supplement~     form in Western countries. These supplements contain relatively high amounts of isoflavones,~     and the question is if these concentrations still exert beneficial effects or whether~     negative effects become dominant. Therefore, the investigators will study the effect of~     intake of one dose of isoflavones, as compared to placebo, for eight weeks on~     gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal,~     equol-producing women.~   "
139208|NCT01232738|"~     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons~     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and~     loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no~     cure for ALS.~      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means~     that the nervous system may be protected against weakening. It is known that rasagiline has~     possible neuroprotective characteristics and it is approved for use for patients with~     another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.~   "
139209|NCT01232725|"~     Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for~     all infants, optimizes intellect, and provides protection against infectious and atopic~     diseases in childhood as well as decreasing risks for obesity, hypertension and other~     chronic diseases. Infants with the highest risk of life-long disability, very low~     birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US.~     Maternal milk is not always available, and pasteurized donor human milk is an alternative~     that requires investigation. Whether donor milk conveys health and developmental advantages~     similar to those bestowed by maternal milk is unknown. By determining the effects of donor~     milk on health and developmental outcomes when compared to preterm infant formula, the~     investigators seek to optimize outcomes in this fragile population. The hypothesis of our~     donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is~     associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a~     preterm infant formula diet.~   "
139210|NCT01232712|"~     The scientific approach behind this study is to develop novel anti-cancer therapeutic~     vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T~     lymphocytes populations and can be be applicable to the majority of the target population.~   "
139211|NCT01232699|"~     Internet-based weight control programs have been shown effective in producing weight loss,~     but in-person delivery of behavioral weight control produces significantly greater weight~     loss than on-line delivery of the same program. Motivational Interviewing has been shown to~     increase weight loss when delivered as an adjunct to in-person weight loss programs but has~     not been examined in conjunction with web-based obesity treatment. Therefore, the overall~     goal of this project is to determine if the addition of on-line Motivational Interviewing to~     a web-based group behavioral obesity treatment program will augment weight loss outcomes.~   "
139212|NCT01232686|"~     The study investigates whether shared online access to epidemiological data for general~     practitioners, disease prevention officers, emergency care services and microbiology~     laboratories changes clinical practice with regard to testing, diagnosing and treatment of~     communicable diseases. The main hypothesis is that online access for general practitioner~     to epidemiological data about communicable diseases changes clinical practice for testing,~     diagnosing and treatment of communicable diseases.~   "
139213|NCT01232673|"~     A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an~     ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical~     revascularization) will be selected and undergo local transplantation of ABMSCs. The~     efficacy/safety of this therapy will be assessed by using several endpoints such as (a)~     prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to~     assess the limb ischemia and hypoxia the several tests and measurements will be performed~     pre- and post transplantation at a variety of time intervals. The measurements include:~     TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin~     perfusion pressure, ABI-ankle brachial index, LDP-laser Doppler baseline and heat perfusion~     assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of~     biochemical and hematological tests of peripheral venous blood sample will be performed.The~     quality form EQ-50 will be completed.~      8.1 Primary objective: To evaluate an efficacy-safety profile of autologous bone marrow stem~     cells (ABMSCs) transplantated into chronically and critically ischemic limb (CLI) and into~     diabetic foot in stage IV Fontaine, Rutherfod 4-6 classification.~      8.2 Secondary objectives: 8.2.1 To assess effect of ABMSCs on tissue perfusion of ischemic~     limb after transplantation by transcutaneous oximetry and the laser Doppler flowmetry using~     Periflux 5000 system under normal and provocation test conditions. In addition, wound~     healing of ulcers will be evaluated using a planimetry method from photographs of affected~     skin taken pre- and post-transplantation.~      8.2.2 Relationship between CD 34 progenitor counts separated on gradient-density separation~     centrifuge from Harvest Technologies and overall effectiveness and safety to treat ischemic~     limb.~      8.3 Priorities: Beside assessment of effectiveness and safety of ABMSCs transplantation~     ultimate emphasis will be put on avoiding limb amputation. This has significant~     socioeconomic impact. Therefore this project belongs to the priority programs of clinical~     research in cardiovascular diseases.~   "
139223|NCT01232543|"~     The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are~     administered Product 0405 for the treatment of Atopic Dermatitis~   "
139215|NCT01232647|"~     Vitamin K is thought to be important for bone health because it activates several proteins~     involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green~     leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main~     dietary form of vitamin K (called K1) or another common form which our bodies make from~     K1(called MK4), to improve bone health have given mixed results. This confusion is thought~     to have arisen because these studies involved people who already had enough vitamin K or did~     not have osteoporosis. We want to test the hypothesis that treatment with bisphosphonates~     combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer~     additional benefit on skeletal metabolism and reduction of fracture risk. We want to test~     this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the~     recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with~     low vitamin K will then be recruited to study the effect of supplementation with either K1~     or MK4.~   "
139216|NCT01232634|"~     The purpose of this study is to test the external validity of the systemic ultrasound~     protocol for data acquisition and interpretation, in order to diagnose soft tissue and~     osteochondral abnormalities in hemophilic children.~   "
139217|NCT01232621|"~     In the Approach Study, the investigators will study the 'process' by which Substitute~     Decision Makers (SDMs) are approached for consent for their loved one's participation in~     critical care research. The investigators will randomize SDMs of critically ill patients who~     are eligible to participate in any research study in operation to either 'physician~     introduction' of the research team or 'non-physician approach (non-physician)' in which~     research coordinators are introduced by allied health care team members or introduce~     themselves directly to SDMs. This study seeks to identify important features of the 'consent~     to research' process that can be modified to enhance both SDM satisfaction with the consent~     process and recruitment into critical care research studies.~   "
139218|NCT01232608|"~     Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular~     disease, and people with type 2 diabetes have a two- to four-fold increased risk for~     cardiovascular morbidity and mortality. Physical activity is a well established therapeutic~     modality for type 2 diabetes. In patients with coronary artery disease (CAD), several~     clinical trials have shown reduced mortality and reduced progression of atherosclerosis with~     lifestyle intervention including physical activity. But few studies have investigated the~     effect of physical training in patients suffering from both diseases.~      The aim of this study is to investigate the effect of one year of organized physical~     exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic~     state and progression of atherosclerosis.~      The project is a randomized, controlled, open study on physical exercise. 136 patients will~     be randomized at inclusion to a physical exercise group or a control group, the latter with~     normal follow-up and not discouraged form physical activity. The intervention period will~     be 12 months, and the physical training program will be developed and conducted in~     collaboration with Norwegian School of Sport Sciences. The inclusion of patients started~     summer 2010, the exercise program begins in September 2010 and the practical issues of the~     study is planned to end during spring 2012.~      The main hypothesis is that physical exercise improves the glucometabolic state and reduces~     progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes,~     and secondary that physical exercise induces favourable changes in cardiovascular risk~     factors, use of medication, and co-morbidity associated with diabetes.~   "
139219|NCT01232595|"~     This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in~     patients who have moderate Clostridium difficile infections.~   "
139220|NCT01232582|"~     Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence~     and prevalence is steadily on the rise in correspondence with the increasing longevity of~     the population. Spinal pain, encompassing lower back, thoracic and neck pain, is a very~     common type of chronic pain that can greatly reduce quality of life. Facet joint pain is~     most often associated with facet arthropathy or degenerative arthritis of the joint. This~     condition develops due to progressive wear and tear caused by the small but repetitive~     strain of the joints throughout a lifetime. Strain and inflammation can induce fluid~     distention of the joints which in turn can result in compression of the nerve roots of the~     joint - the origin of the chronic pain.~      Current treatments for facet arthropathy and pain include oral medications, intra-articular~     injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency~     ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of~     the nerves).~      The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal~     ablation of tissue. Results from feasibility studies, including those from the FDA approved~     feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for~     patients with bone metastases. It is reasonable to assume that this palliative effect of~     MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are~     directed to the facet joints. The highly-target focal ablation could also diminish the risk~     of complications that are often associated with other less selective denervation techniques.~      The objective of this trial is to evaluate the safety and effectiveness of the ExAblate~     system and the treatment of pain resulting from facet joint osteoarthritis.~   "
139221|NCT01232569|"~     This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the~     reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in~     combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients~     with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study,~     patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously~     every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study,~     patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from~     Week 24 to Week 96 using a pre-filled syringe or an auto-injector.~   "
139222|NCT01232556|"~     The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus~     rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not~     candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate~     the superiority of this combination compared with an active comparator arm (investigator's~     choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of~     overall survival.~   "
139225|NCT01232517|"~     The purpose of this research study is to gather information about the NeuroVision System~     (which is FDA cleared for this indication) during the placement of pedicle screws.~     NeuroVision is a machine that monitors nerve activity during surgery and will alert the~     surgeon if there are any nerve-related issues during screw placement. The use of nerve~     monitoring is standard of care at most centers during spine surgery. The standard monitoring~     for screws placed is performed after the screw is placed, to ensure it is well positioned in~     the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision~     System has a novel feature called Dynamic Screw Test that allows for that monitoring to be~     performed as the screw is placed, rather than after the fact. This study is being done to~     determine if this real-time monitoring of screw placement provides beneficial additional~     information to the operating surgeon to prevent misplacement of screws before it happens.~   "
139226|NCT01232504|"~     We conducted a prospective, multicenter, open-label randomized trial to compare the~     antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF),~     Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and~     rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.~   "
139227|NCT01232491|"~     This trial is conducted in Europe, and North and South America. The aim of this trial is to~     investigate if a dietary intervention has an effect on weight when initiating insulin~     treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs~     (OADs).~   "
139228|NCT01232478|"~     The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence~     promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement.~     Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP~     consists of training in the CF My Way program (a validated problem-solving adherence~     promotion intervention). The other half of the centers will receive CAP in year 2 of the~     study. Participants are patients age 11-20 years old who are diagnosed with CF and have been~     prescribed at least one of the following medications for at least 6 months prior to signing~     the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled~     compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung~     function decline rates, exacerbation rates, and patient reported measures including health~     related quality of life and CF knowledge and skills, as secondary outcomes.~      A central goal of this study is to test the effectiveness of the comprehensive adherence~     program (CAP), described above, versus standard care (SC) for adolescents and young adults~     seen in outpatient CF clinics.~   "
139229|NCT01232465|"~     Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients~     undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any,~     between IVF success and sperm DNA integrity.~   "
139230|NCT01232452|"~     The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in~     combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as~     first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma~     (NSCLC).~   "
139231|NCT01232439|"~     To measure the occupancy of brain kappa opioid receptors after single oral doses of~     LY2456302.~   "
139232|NCT01232426|"~     Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually~     referred to as Mallet fractures. Treatment of Mallet fractures remains controversial.~     Although no differences in clinical results are reported between conservative treatment and~     operative treatment, operative treatment is suggested for fractures involving more than 30%~     of articular surface. There are many different operative techniques, all with specific~     disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures~     with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet~     splint.~   "
139233|NCT01232413|"~     The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on~     electrocardiogram (ECG) measurements.~   "
139234|NCT01232400|"~     The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac~     function and electrophysiology; to assess the effects of esmolol treatment on serum~     adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after~     subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the~     index SAH. The primary outcome will be change in systolic function - ejection fraction by~     Simpson's rule (baseline versus Day 7 +/- 2 after SAH).~   "
139235|NCT01232387|"~     Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a~     cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.~      Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when~     the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses~     pass from mother to baby through the placenta and only waste products pass from baby to~     mother through the placenta. Whole blood cells do not normally cross the placenta in~     significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to~     mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant~     woman does not know this occurs. It is only discovered if a special blood test that is~     labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid~     elution test is done. As mild FMH hurts no one, this test is not part of routine care. In~     most cases, testing is done only if a baby is born sick with unexplained anemia. Severe FMH,~     which can cause the baby to become sick from anemia (low red blood cell count) is caused by~     large blood loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused~     by FMH can result in death of the baby before or after birth, or significant illness in the~     newborn period. Short term problems for the baby include difficulty breathing, difficulty~     maintaining blood pressure, and difficulty providing oxygen to all parts of the body. This~     can cause multiple problems with the function of internal organs including the liver,~     kidneys, intestines, and brain. Babies who become sick from severe FMH can develop long-term~     problems including cerebral palsy (a lifelong problem with body movements) and/or mental~     retardation.~      It is not known why some pregnancies are affected by FMH and others are not. It is thought~     that FMH may occur more frequently now than in the past, but no one knows why. If identified~     early, FMH is readily treatable by blood transfusion of the baby before or after birth~     and/or early delivery. Current laboratory testing for FMH is difficult and expensive. There~     is great need identify high risk patients early in pregnancy in order to treat the condition~     before the baby gets sick.~      Approach: Five hundred women will be asked to participate in the study at the time they are~     admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study~     mothers will be tested for anemia. Mothers of anemic babies will donate blood for~     confirmation of FMH by established laboratory methods as well as for development of a new~     laboratory screening protocol. All mothers will provide medical, social, environmental, and~     full pregnancy history. Risk factors for FMH will be identified by statistical analysis of~     this information.~   "
139299|NCT01231555|"~     This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects~     consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg~     once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The~     background ART for all 3 arms will be chosen by the Investigators and will be either~     abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination~     (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be~     evaluated.~   "
139236|NCT01232374|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I~     study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in~     patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the~     safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase~     II trial designed to assess the efficacy of the combination of Nimotuzumab administered~     concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its~     side-effect and toxicity.~   "
139237|NCT01232361|"~     The main purpose of this study is to find out how stimulant medications (methylphenidate or~     amphetamine/ dextroamphetamine) for the treatment of Attention Deficit Hyperactivity~     Disorder (ADHD)are processed in HIV-1 infected and HIV-uninfected children and adolescents.~   "
139238|NCT01232348|"~     The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs,~     unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on~     bronchial asthma and Patient satisfaction~   "
139239|NCT01232335|"~     The purpose of this study is to confirm the safety profile for long term treatment and~     maximize doses and the control status on bronchial asthma in daily clinical usage~   "
139240|NCT01232322|"~     The purpose of this study is to investigate the safety and efficacy for long term treatment~     of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical~     usage.~   "
139241|NCT01232309|"~     Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and~     stroke, are the leading causes of death globally. Important risk factors for CVDs include~     elevated serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol,~     triglycerides, and low high-density lipoprotein (HDL)-cholesterol. Elevated oxidized LDL,~     a pro-inflammatory villain, has also emerged as an important risk factor for the development~     of CVDs. There is a growing need to identify safe and effective nutritional interventions~     that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data~     from many studies in humans have shown various health benefits provided by dietary fiber~     intake, including an inverse association with the risk of developing cardiovascular disease.~     The primary purpose of this study is to determine whether daily consumption for 6 weeks of~     chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of~     oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan~     on other cardiovascular risk factors will also be evaluated.~   "
139242|NCT01232296|"~     The purpose of this open-label, randomized, phase II study is to compare the safety and~     efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with~     advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the~     Asia-Pacific region.~   "
139243|NCT01232283|"~     This study will evaluate the effects of an experimental (being tested) study drug called~     apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and~     therefore improves the symptoms of psoriasis. The purpose of this study is to test~     apremilast and compare its effects to placebo (an inactive substance which contains no~     medicine but is in the same form as the drug). This study will test efficacy (improvement of~     signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.~   "
139244|NCT01232270|"~     Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in~     lowering propofol requirement for conscious sedation under spinal anesthesia.~   "
139245|NCT01232257|"~     Cardiovascular morbidity and mortality is high in CKD patients. Nitric oxide (NO) deficiency~     plays a crucial role in progression of CKD. This leads to endothelial dysfunction,~     hypertension, and inflammation. Hydrogen sulfide (H2S) could serve as a backup mechanism for~     NO deficiency in CKD. N-acetylcysteine (NAC) is a derivate of cysteine and this is the main~     substrate for H2S production. Therefore, NAC should enable us to stimulate H2S production in~     humans. Our objective is to investigate the effect of NAC on plasma H2S levels and on~     markers of oxidative stress, inflammation, and endothelial dysfunction in healthy~     volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in~     H2S levels after treatment with NAC.~   "
139246|NCT01232244|"~     Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream~     in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and~     glucagon are all known to regulate parameters such as appetite, food intake and induce~     weight loss.~      Therefore we want to investigate mechanistic relations between the three hormones.~   "
139247|NCT01232231|"~     The purpose of this study is to determine the effectiveness of topical and oral antibiotics~     in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those~     living in the community. We hypothesize that a greater proportion of those who receive~     intervention will eliminate MRSA carriage compared to those who do not receive any~     intervention.~   "
139248|NCT01232218|"~     The purpose of this study is to determine if a specific stretching and strengthening~     protocol, in addition to current standard treatment, is more effective for treating~     post-stroke shoulder pain than current standard treatment alone.~   "
139249|NCT01232205|"~     The purpose of this study is to investigate the benefit of several micro nutrients of~     antioxidants (using milk) in a cohort of women with low antioxidant status and the changes~     in cell-free mRNA.~   "
139250|NCT01232192|"~     The purpose of this study is to determine whether antenatal model in vaginosis are effective~     in preventing vaginal infection and preterm delivery~   "
139251|NCT01232179|"~     Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal~     photocoagulation (PRP) which can improve the visual prognosis in this complication~     significantly. However , the treatment may also resulting adverse effects such as blurring~     of central vision, visual field constriction and disturbance in dark adaptation and contrast~     vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause~     regression of the neovascularization while minimizing some of the risks and complication~     associated of treatment of PDR with these two methods.~   "
139382|NCT01230463|"~     The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of~     ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours~     after an adult spine surgery.~   "
139252|NCT01232166|"~     Background: Endotracheal intubation has become a well established standard in protecting the~     airway during surgical procedures, and in emergency situations. Serious complications can~     occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If~     unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and~     hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the~     golden standard to verify the correct endotracheal tube placement is bilateral ausculation~     of the chest. However this is not always satisfactory, as breath sounds can be transmitted~     to the opposite side of the chest in spite of endobronchial intubation. Therefore other~     clinical tests to verify the correct endotracheal tube placement have become part of daily~     clinical practice, like observation of symmetric chest movements, and use of the cm markings~     printed on the endotracheal tube. However so far no study investigated which of these~     bedside clinical methods works best in detecting an inadvertently placed endobronchial tube~     in adults. We therefore designed a study to compare three different bedside methods to~     verify endotracheal or endobronchial tube placement.~      Objective: To determine which of four commonly used bedside methods of detecting inadvertent~     endobronchial intubation in adults has the highest sensitivity and specificity.~      Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital,~     department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75~     years, scheduled for elective gynaecological or urological surgery.~      Interventions: Patients were randomly assigned to eight study groups. In four groups, an~     endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas~     in the other four groups the tube was positioned in the right mainstem bronchus. The four~     groups differed in the bedside test used to verify the position of the endotracheal tube.~     First-year residents and experienced anaesthesiologists independently performed one of the~     following randomly assigned bedside tests in each patient in an effort to determine whether~     the tube was properly positioned in the trachea: 1) bilateral auscultation of the chest~     (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3)~     estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a~     combination of all three mentioned tests (All Three).~      Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position~     as independently assessed by first-year anaesthesia residents and experienced~     anaesthesiologists with each of the four bedside tests.~   "
139253|NCT01232153|"~     Recent studies reports feasibility, effectiveness and even less complications of using NIV~     for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has~     been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate~     same results or even more in that conditions.~   "
139254|NCT01232140|"~     Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease~     (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial~     pathogens. These exacerbations are often treated with a combination of corticosteroids,~     bronchodilators and antibiotics, but the benefit of antibiotic therapy remains~     controversial. Several trials studying antibiotic treatment in AECOPD showed conflicting~     data, with several large studies failing to demonstrate superiority of antibiotic therapy~     over placebo. Other trials indicated that antibiotic therapy is effective in patients who~     have at least two of the following symptoms: increased dyspnoea, increased sputum volume and~     increased sputum purulence. Ever since sputum purulence has been used as a predictive marker~     in AECOPD, a strategy that has been integrated in the GOLD guideline for treatment of~     AECOPD. However, the color of sputum reported by patients is not always reliable and~     inspection of sputum is not always possible. Several serum biomarkers such as C-reactive~     protein (CRP) and procalcitonin (PCT) are now available. In a recent trial of doxycycline in~     addition to systemic corticosteroids for patients hospitalized with AECOPD we found that CRP~     might be valuable as a marker predictive of response to antibiotic treatment in AECOPD.~   "
139255|NCT01232127|"~     The purpose of this study is to assess the effects of famotidine, given twice daily, on~     atazanavir administered with ritonavir and tenofovir in HIV-infected participants.~   "
139256|NCT01232114|"~     Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily~     becoming a public health problem.Simotang is a classical formula that has been used to treat~     gastrointestinal disorders for hundreds of years [9] and was approved as an oral liquid drug~     by the Chinese National Food and Drug Administration in the 1980s.In this study,patients~     with functional dyspepsia were divided according to the inclusive criteria into treatment~     group and control group randomly, who were given Simo decoction or Domperidone tablets for~     14 days。And then the gastric emptying, Symptoms in plasma were observed before and after~     treatment in mult-center.~   "
139257|NCT01232101|"~     The study is investigator initiated. Tumors that gives the narrowing of the bile ducts~     prevents bile from flowing from the liver to the intestine resulting in jaundice and the~     risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct~     strictures have routinely been treated them with plastic stents. The plastic stents have~     been replaced by self expandable metallic stents.~      These stents remain open longer for reasons that they have a larger diameter so that the~     bile flows through more easily. One problem with these stents, however, is that the tumor~     growing through the wire mesh which forms the wall of the stent. This has led to the~     development of so-called covered stents. Whether covered stents have longer patency is~     unclear as well as whether they are as safe. There is reason to believe that covered stents~     remain open longer, but there may be an increased risk of migration and other complications.~      The purpose is to prospectively and randomized compare the two stent types. The study~     endpoint is the clogging of the stent or the patient's death. We also monitor complications,~     regress time of the jaundice and success rate of stent placement~   "
139258|NCT01232088|"~     Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338).~     Standardized color coded labels for user applied syringes enjoy strong support from many~     health professionals, thinking that this might increase patient safety. Whether this is true~     or not warrants further research.~   "
139259|NCT01232075|"~     The aim of this randomized controlled trial is to compare the efficacy of extended letrozole~     regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day~     3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine~     insemination .~   "
139260|NCT01232062|"~     To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined~     with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple~     negative metastatic breast cancer patients~   "
139261|NCT01232049|"~     This study is designed to evaluate a pharmacokinetic drug interaction and safety between~     Pitavastatin and Valsartan in healthy male subjects~   "
139262|NCT01232036|"~     This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics~     and safety after oral administration of Glucophage with those after oral administration of~     HL-018 in healthy male volunteers~   "
139263|NCT01232023|"~     This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics~     of indobufen in healthy subjects.~   "
139264|NCT01232010|"~     This study is designed to investigate the effect of renal impairment on the safety and~     pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.~   "
139266|NCT01231984|"~     Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin~     therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy~     profile of longer pen needles may appeal to many diabetic patients as the shorter needle may~     be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in~     length are generally used for insulin injection in patients considered thin or normal~     weight, longer (12.7 mm) needles are still often prescribed for overweight or obese patients~     with diabetes. Since skin thickness is nearly constant across a range of body mass index~     (BMI), a clear rationale exists for the use of shorter needles in obese patients. (Gibney et~     al., CMRO 2010)~      The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32~     Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent~     glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and~     the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.~   "
139267|NCT01231971|"~     The purpose of this study is to build upon the information obtained in the original~     Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study~     funded through an NIH grant under the American Recovery and Reinvestment Act), to examine~     how brain imaging technology can be used with other tests to measure the progression of mild~     cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the~     neuroscience of AD. This information will aid in the early detection of AD, and in measuring~     the effectiveness of treatments in future clinical trials.~   "
139268|NCT01231958|"~     The investigators long-term goal is to understand the complex interactions of diet and other~     behavioral and environmental factors, genetics, and psychosocial stress on the high and~     apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto~     Rican adults.~   "
139269|NCT01231945|"~     Background:~      - Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative~     to Pap smears and visual inspection for cervical cancer screening of underserved women. Two~     low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been~     developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3~     hours to run and may provide point-of-care (diagnostic testing at or near the site of~     patient care) testing for HPV. Researchers are interested in evaluating both tests to~     determine the best strategy for HPV testing of women who live in rural or underserved areas~     that have a high prevalence of cervical cancer diagnoses.~      Objectives:~        -  To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting~          cervical cancer and precancerous lesions.~        -  To evaluate the best low-cost test or combination of tests for women who have been~          referred for cervical cancer screening or treatment.~        -  To compare the clinical performance of self-collected specimens versus~          clinician-collected specimens in detecting cervical cancer and precancerous lesions.~      Eligibility:~      - Women between 25 and 65 years of age who live in rural China.~      Design:~        -  This study involves an initial testing visit and a 1-year followup visit for a~          high-risk subgroup.~        -  Participants will have the HPV E6 test, careHPV, and a visual inspection test for~          cervical cancer. For comparison, participants will also have the standard HPV test~          approved by the U.S. Food and Drug Administration.~        -  Participants who test positive for HPV on any of the above tests will also have~          colposcopy to collect samples of cervical tissue for further study.~        -  A random sample of women who test negative for HPV will also have colposcopy.~          Participants may also have biopsies if there is visual evidence of cervical~          abnormalities.~        -  At the 1-year followup visit, participants in the high-risk subgroup will have the same~          tests as in the previous visit..~   "
139270|NCT01231932|"~     Background:~      - Fatigue, a common side effect of cancer and its treatment, is found in up to 96% of cancer~     patients. Fatigue is difficult to treat because its cause is poorly understood. Research has~     indicated that cancer-related fatigue may be caused by a number of factors, including immune~     system responses to cancer treatment. Researchers are interested in studying individuals who~     are receiving cancer treatment in order to better understand the causes of fatigue.~      Objectives:~      - To study fatigue in individuals who are receiving cancer treatment.~      Eligibility:~      - Individuals at least 18 years of age who have localized cancer that has not spread and are~     scheduled to start cancer treatment at the National Institutes of Health.~      Design:~        -  This study involves an initial screening visit and a minimum of three outpatient~          visits.~        -  Participants will be screened with a medical history, and blood tests.~        -  Participants who are scheduled to have cycles of cancer treatment will be seen once~          before the start of each cycle, once at the midpoint of each cycle, and once at the end~          of each cycle. Participants whose treatment does not follow a cycle will be seen before~          the start of treatment; 2 weeks after starting treatment; and 1 month, 3 months, 6~          months, and 1 year after starting treatment, for a total of six outpatient visits.~        -  At each study visit, participants will complete the following tasks:~        -  Questionnaires about physical activity, fatigue, depression, and quality of life.~        -  Computerized cognitive tests of memory, attention, and ability to follow directions.~          The tests are timed to determine whether these brain functions are affected by cancer~          treatment and whether they occur with fatigue symptoms.~        -  Blood samples to monitor immune system and other responses to treatment.~        -  Hand grip strength test to evaluate physical strength.~        -  Physical activity monitor and journals to study how fatigue affects physical activity.~        -  Participants who need additional cycles of cancer treatment will continue to have~          visits until the end of the third cycle, for a maximum of nine outpatient visits.~        -  Treatment will not be provided under this study.~   "
139271|NCT01231919|"~     This phase I trial is studying the side effects, best way to give, and best dose of Akt~     inhibitor MK2206 (MK2206) in treating patients with recurrent or refractory solid tumors or~     leukemia. MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
139272|NCT01231906|"~     This randomized phase III trial studies combination chemotherapy to see how well it works~     compared to combination chemotherapy with topotecan hydrochloride in treating patients with~     non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine~     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more tumor cells. It is not yet known whether combination~     chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.~   "
139273|NCT01231893|"~     The purpose of this experimental therapy is an assessment of the safety and feasibility of~     transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained~     from the olfactory mucosa in patients with complete spinal cord injury.~   "
139274|NCT01231880|"~     The investigators hypothesize that schoolchildren treated with IPT using DP over one year of~     follow-up will have a different risk of clinical malaria compared to those treated with~     placebo.~   "
139300|NCT01231542|"~     This study will be a phase I, open label, two arm, fixed sequence crossover study to~     investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK)~     of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration.~     Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572~     50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin~     600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily~     for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily~     for 14 days. Serial PK sampling will be completed following the last dose of each treatment.~     Safety and tolerability will be assessed throughout the study through assessment of adverse~     events (AEs), and clinical laboratory tests.~      This study will be conducted at one center in the US with healthy adult male and female~     subjects.~   "
139874|NCT01223976|"~     The purpose of this study is to determine the level of agreement between QuantiFeron -TB~     Gold test (QFT-G)and Tubeculin skin test (TST)for screening of latent tuberculosis in~     patients suffering from psoriasis.~   "
139275|NCT01231867|"~     Patients who have experienced and survived non-ST segment elevation acute coronary syndromes~     are often prescribed a combination of aspirin and clopidogrel to thin the blood and prevent~     further acute coronary episodes. Both clopidogrel and aspirin may cause stomach bleeds and~     so a prophylactic proton pump inhibitor is frequently co-prescribed in order to prevent such~     bleeds. Recent mechanistic and observational studies suggest proton pump inhibitors may~     reduce the effectiveness of clopidogrel and so patients may not benefit as much as expected~     from combined aspirin and clopidogrel. The investigators propose a cohort study of patients~     prescribed clopidogrel + aspirin. Amongst these patients the investigators will measure the~     relative rate of acute coronary syndrome and death comparing patients with and without~     proton pump inhibitor treatment. To provide a more complete picture of the risks and~     benefits of treatment the investigators will also measure the relative rate of stomach~     bleeds in the same groups of patients. In addition, whether the inhibitory effect of proton~     pump inhibitors on the protective effect of clopidogrel is due to their inhibition of drug~     metabolising enzymes will be explored by assessing the effects of other drugs that inhibit~     the same enzymes.~   "
139276|NCT01231854|"~     The purpose of this study is to investigate the comparative efficacy, safety and efficiency~     of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.~   "
139277|NCT01231841|"~     RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine,~     may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II~     trial is studying how well giving anti-thymocyte globulin together with cyclosporine as~     first-line therapy works in treating patients with severe aplastic anemia.~   "
139278|NCT01231828|"~     The project will improve scientific knowledge regarding a recent law applying potentially to~     every french driver. It will give for the first time an indication on the impact of alerting~     treatments on driving risks. It will reinforce the links between different research~     environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers~     supervision, virtual reality, pharmacology) among the Réseau Eveil Sommeil Attention et~     Transports (RESAT) network.~   "
139279|NCT01231815|"~     Heart transplantation is the ultimate therapeutic option in patients with end-stage heart~     failure. Since advances in the treatment of acute rejection has increased early transplant~     survival, cardiac allograft vasculopathy (CAV) is the main factor limiting long-term~     survival. The prevalence of angiographically proven CAV is high, documented in 40-50% of~     transplant recipients 5 years after transplantation. Therefore, annual coronary angiography~     remains widely used to monitor transplanted patients, although pathologic studies and~     intravascular ultrasonography have demonstrated that coronary angiography underestimates the~     severity of CAV. Perfusion SPECT may underestimate allograft vasculopathy in case of diffuse~     coronary lesions. In this setting, the assessment of coronary reserve by means of Positron~     Emission Tomography (PET) and perfusion cardiac magnetic resonance imaging (CMR) have not~     been investigated.~   "
139280|NCT01231802|"~     The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast~     cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.~   "
139281|NCT01231789|"~     The current study is designed to clarify the neuroprotective effect of remote ischemic~     preconditioning on the patients underwent open-heart cardiac surgery.~   "
139282|NCT01231776|"~     Due to various causes, such as brain impairment, environment changes, anxious,et al.~     patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In~     chinese traditional medicine, acupuncture can improve the quality of sleep in patients with~     sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients~     with heart operations.~   "
139283|NCT01231763|"~     This study is being done to find out what women would want in a film vaginal product for~     human immunodeficiency virus (HIV) prevention, especially what it should look like and how~     to apply it.~      The investigators hypothesize that women will prefer a smooth, clear, and rectangular~     quick-dissolve vaginal film for HIV prevention over a textured, opaque, square~     quick-dissolve vaginal film.~   "
139284|NCT01231750|"~     The purpose of this study is to test the hypothesis that application of topical capsaicin in~     patients with stable angina will result in improved exercise tolerance and reduced cardiac~     ischemia.~   "
139285|NCT01231737|"~     Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract~     infections risked recurrent infection. Urinary tract infection causes marked discomfort for~     the patient, has a negative impact upon quality of life, and is associated with high social~     and health costs in terms of specialist appointments, laboratory and instrumental tests and~     prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been~     proposed, doubts persist about the most efficacious pharmacological agents, duration of~     prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is~     suspended.~      Aims of the study:~        1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):~             -  in reducing the number of urinary tract infection episodes during prophylaxis~             -  in reducing the number of urinary tract infection episodes after prophylaxis~             -  in improving the patient's quality of life .~        2. To assess :~             -  Tolerability of antibiotic prophylaxis~             -  The incidence of resistance to antibiotic therapy~   "
139286|NCT01231724|"~     The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is~     safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).~   "
139311|NCT01231399|"~     RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood~     flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing, or by stopping them from spreading. Giving~     everolimus together with combination chemotherapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when~     given together with combination chemotherapy in treating patients with metastatic stomach or~     esophageal cancer that has spread to other places in the body.~   "
139383|NCT01230450|"~     Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study~     for comparing the relatively new Single incision sub-urethral tapes with the standard~     surgical treatment of female urodynamic stress incontinence (USI).~   "
139287|NCT01231711|"~     Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF)~     and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health~     and well-being of US service women and men. Although OEF/OIF service members and veterans~     are at high risk of developing sub-threshold combat stress and depressive symptoms or full~     disorders in the post-deployment period, only a small fraction ever receive care. The VETS~     PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping~     skills training with peer-to-peer support and counseling, was specifically designed to offer~     the returning OEF/OIF service member or veteran an accessible and confidential first step to~     care.~      Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was~     contracted to supervise a pilot study of potential benefit, feasibility and safety of the~     VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison~     study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase~     1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be~     evaluated through changes in the following clinical self-report measures: i) symptoms of~     depressed mood (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post~     traumatic stress disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and~     iii) functional status (Short Form 12, SF-12), as well as changes in key attitudes toward~     mental health care seeking (intent to seek treatment, mental health self-efficacy and~     stigma).~   "
139288|NCT01231698|"~     The purpose of this study is investigate the effects on systemic hemodynamics and organ~     function of esmolol when used to maintain heart rate below a predefined threshold in~     patients with septic shock.~   "
139289|NCT01231685|"~     HIV infection exerts a negative impact on the course of HCV infection. Co-infected~     individuals progress more rapidly to liver fibrosis, cirrhosis and ESLD compared to those~     infected with HCV alone. Some of the this accelerated fibrosis may be related to longterm~     chronic toxicity from protease inhibitor based ART.~      Hypothesis: Switching from ritonavir boosted-PI based ART regimen to a Raltegravir-based~     regimen will reduce the rate of hepatic fibrosis progression in HIV-HCV co-infected patients~     as measured by transient elastography (Fibroscan®) and the AST-to-platelet ratio index~     (APRI).~   "
139290|NCT01231672|"~     A prognostic score was proposed by the investigative team to predict death at 1 month. This~     score is based on certain biological markers, scored under emergency conditions in the first~     24 hours of routine clinical practice management for septic shock.~      The main objective of this multicenter study is to validate the performance of the score in~     terms of area under the ROC curve and negative predictive value.~   "
139291|NCT01231659|"~     This is a multi-center, Israeli phase II open label study evaluating treatment with RAD001~     (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after~     recurrence or progression on Tamoxifen, Anastrozole or Examestane.~      There are no treatments specifically approved after recurrence or progression on AIs.~     Available options, based on common clinical practice and several treatment guidelines (e.g.~     NCCN treatment guidelines 2008), include fulvestrant.~      Combining RAD001 with letrazole is a rational approach to the treatment of advanced Brest~     Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti~     angiogenesis while at the same time potentially preventing the development of letrazole~     resistance.~   "
139292|NCT01231646|"~     Women who take folate (folic acid) before getting pregnant can lower the risk of giving~     birth to infant with certain birth defects. However, some medications may affect the action~     of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on~     how folate works in our body.~   "
139293|NCT01231633|"~     The purpose of this study is to compare visual improvement and total number of intraocular~     injections in eyes with macular edema following central retinal vein occlusion (CRVO)after~     initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).~   "
139294|NCT01231620|"~     The purpose of this study is to test the safety and efficacy of zanamivir given~     intravenously and how well it works at two different doses in hospitalized adolescents and~     adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating~     flu.~   "
139295|NCT01231607|"~     The purpose of this six month study is to show that dutasteride is safe and more effective~     than placebo, and at least as safe and effective as finasteride in treating hair loss in men~     with androgenetic alopecia. Three doses of dutasteride will be investigated.~   "
139296|NCT01231594|"~     This rollover study is designed to provide continued access to GSK2118436 for eligible~     subjects with BRAF mutation-positive tumors who have previously participated in a~     GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of~     progressive disease and who have tolerated GSK2118436 in the parent study without~     significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the~     treatment received in their parent study. Safety assessments (physical examinations, vital~     signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and~     monitoring of adverse events) will be made throughout the study. Clinical activity will be~     assessed using local standard of care imaging practices and the appropriate response~     criteria as determined by the investigator.~   "
139297|NCT01231581|"~     GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase~     activity and has demonstrated potent anti-proliferative activity against human pancreatic~     cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK~     inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with~     metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with~     oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria~     are met. The primary objective will be to compare the overall survival of subjects in the~     GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary~     objectives include comparison of progression free survival, overall response rate, and~     duration of response between the two arms. Exploratory research objectives include the~     evaluation of population pharmacokinetics as well as blood and tissue based biomarkers.~     Safety will also be monitored throughout dosing.~      Once the determined number of survival events has occurred, if subjects are eligible, they~     will have the option to enter MEK114375, an open-label, Phase Ib rollover study of~     GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.~   "
139301|NCT01231529|"~     GSK1349572 is an integrase inhibitor that is currently in clinical development for the~     treatment of human immunodeficiency virus (HIV) infection. GSK1349572 is metabolized~     primarily by uridine diphosphate glucuronosyltransferase (UGT)1A1 with a minor role of~     Cytochrome P450 (CYP)3A. Hepatic impairment could potentially alter the clearance and plasma~     protein binding of GSK1349572. This study will evaluate the single dose pharmacokinetics and~     safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic~     impairment based on Child-Pugh category.~      This is a single-dose, open-label, parallel group, two-part, adaptive study in adult males~     and females with mild or moderate hepatic impairment and matched, healthy control subjects~     with normal hepatic function. Healthy control subjects (16) will be matched for gender, age,~     and BMI to the subjects in the mild (8) or moderate (8) hepatic impairment category. In Part~     1, approximately 8 subjects with moderate hepatic impairment (cohort 1) and 8 matched,~     control subjects (cohort 2) will each receive GSK1349572 50 mg as a single dose in the~     fasted state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in~     plasma. Free (unbound) plasma concentrations of GSK1349572 will also be evaluated at sparse,~     selected time points. If the geometric mean total plasma area under the concentration curve~     (AUC) of GSK1349572 is increased by > 2-fold in moderately impaired subjects compared to~     matched controls, Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in~     another group of subjects with mild impairment (8, cohort 3) and matched, control subjects~     (8, cohort 4). Vital signs, electrocardiograms (ECGs), and adverse events will be monitored~     throughout the study. A follow-up visit will occur 7-10 days after the dose of study drug.~   "
139302|NCT01231516|"~     ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel~     group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected~     antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to~     receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to~     an investigator selected background regimen consisting of at least one fully active agent~     plus no more than one second single agent which may or may not be active. Antiviral~     activity, safety, pharmacokinetics (PK), and development of viral resistance will be~     evaluated.~   "
139303|NCT01231503|"~     The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an~     efficacious malaria vaccine that is deliverable through the existing system, the Expanded~     Program on Immunization (EPI) of WHO. This study has been designed to:~        -  Investigate the safety and immunogenicity of 7 infant immunization schedules of the~          experimental malaria vaccine integrated with an EPI regimen.~        -  Investigate how to maximize the antibody response to the experimental malaria vaccine.~   "
139304|NCT01231490|"~     This is a methodological study designed to investigate a new model for testing pain agents~     in the treatment of patients with osteoarthritis (OA). This will be a double-blind,~     randomised, placebo controlled three-way cross-over study in patients with OA of the knee.~   "
139305|NCT01231477|"~     The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and~     surgery on cytokines response.~   "
139306|NCT01231464|"~     The objective of this study is to compare the efficacy and safety of Fluticasone Furoate~     Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with~     Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5~     day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs,~     inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The~     primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS)~     during treatment period, and the secondary endpoints include mean change from baseline in~     nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall~     inference in activities of daily living. Safety measures include AE (Adverse Event) reports,~     ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition,~     reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint,~     only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.~   "
139307|NCT01231451|"~     DMPA (depot medroxyprogesterone acetate or the 'depot' injection) is a widely used~     contraception. It is popular in woman with HIV as it probably still works when you take HIV~     drugs. HIV drugs can increase or decrease the level of other drugs (e.g. contraceptives) in~     your bloodstream which may make them work less well or increase side effects. It is assumed~     that DMPA can be given with HIV drugs there are no studies proving this.~      The purpose of the study is to investigate whether an HIV drug combination containing~     lopinavir/ritonavir affects DMPA when they are taken at the same time.~   "
139308|NCT01231438|"~     Patients with reduced renal function normally develop hyperparathyroidism, which in turn is~     associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may~     be enhanced by an increased level of FGF23 which is often seen in the early stage of renal~     failure. This pilot study will investigate the FGF23-lowering effect of early initiation of~     treatment with a phosphate binder versus active vitamin D in an open crossover design.~   "
139309|NCT01231425|"~     The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as~     adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical,~     thoracic and lumbar pain, under conditions of usual clinical practice as the medical~     acupuncturist performed acupuncture, with and without supplementary pharmacological~     treatment during the first 4 weeks of follow up.~   "
139310|NCT01231412|"~     This randomized phase III trial studies how well graft-vs-host disease (GVHD) prophylaxis~     works in treating patients with hematologic malignancies undergoing unrelated donor~     peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before~     a donor peripheral blood stem cell transplant (PBSCT) helps stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's stem cells. When the~     healthy stem cells from a donor are infused into the patient they may help the patient's~     bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes~     the transplanted cells from a donor can make an immune response against the body's normal~     cells. Giving total-body irradiation (TBI) together with fludarabine phosphate (FLU),~     cyclosporine (CSP), mycophenolate mofetil (MMF), or sirolimus before transplant may stop~     this from happening.~   "
140321|NCT01218100|"~     This study will evaluate the safety and efficacy of first-line treatment with a free~     combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2~     diastolic hypertension (DBP>= 100 mmHg).~   "
139312|NCT01231386|"~     MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation~     and renewal both under physiologically normal as well as in malignant conditions.~     Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing~     tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer~     tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of~     treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum~     will allow for identification of miRNA markers of prognosis and as indicators and potential~     targets for personalized therapies. In this proposal, specimens from patients treated in the~     clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be~     characterized by Dr. Rossi's laboratory and collaborators, and the information gained will~     be applied to develop specific therapies.~   "
139313|NCT01231373|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the safety and~     effectiveness of three different concentrations of an investigational drug, Polidocanol~     Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms~     and appearance of varicose veins.~   "
139314|NCT01231360|"~     Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication~     have altered expression of genes that regulate skeletal muscle metabolism.~      Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle~     insulin resistance and genes that regulate skeletal muscle metabolic function in PAD~     patients with intermittent claudication.~   "
139315|NCT01231347|"~     AMG 479 is an investigational fully human monoclonal antibody that targets type 1~     insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important~     role in the regulation of cell growth and survival.~      Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is~     administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.~      The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall~     survival as compared to placebo and gemcitabine.~   "
139316|NCT01231334|"~     A study comparing the topical application of Aczone® plus Differin® versus Duac® plus~     Differin® in patients with severe facial acne (facial acne vulgaris).~   "
139317|NCT01231321|"~     A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5~     sites in Russia. Adalimumab was administered by subcutaneous injection every other week,~     with dose escalation to weekly dosing available for participants not receiving concomitant~     disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of~     Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety~     measurements were performed throughout the study.~   "
139318|NCT01231308|"~     The study is aimed to compare: Laparoscopic Roux-en-Y-Gastric Bypass (RYGB) + optimal~     medical therapy versus Intensive lifestyle modification and optimal medical therapy in the~     treatment of type 2 diabetes in overweight-to-moderately obese patients (BMI: 28-34kg/m2;~     the lower BMI cut-off will be 26kg/m2 in patients of Asian descent).~      This is a single center, prospective randomized study. The study at the Weill College~     Medical College Diabetes Surgery Center. This study is intended to be a pilot investigation~     whose results can inform clinicians and researchers for future larger or multi-site trials~     of diabetes surgery. This study will also be used for the definition of a core protocol~     for independent randomized clinical trials to be carried out at various centers~     participating in a multinational consortium.~   "
139319|NCT01231295|"~     The primary objective of this study is to characterize cerebral metabolism modifications~     using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal~     Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging~     within this framework, and search for optimal diagnostic thresholds.~   "
139320|NCT01231282|"~     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique~     that characterizes tissue by probing changes in water diffusion secondary to differences in~     the tissue microstructure. These changes in water diffusion result in differences in signal~     intensity on diffusion-weighted images that are quantified with the apparent diffusion~     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be~     diminished, due to the increased number of cells. This will restrict water diffusion,~     identified by increased signal intensity (SI) on native diffusion-weighted images and low~     ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced~     necrosis, the EES will be enlarged due to the lower density of cells, or in case of~     necrosis, the complete absence of cellular organization. This will facilitate water~     diffusion, leading to absent SI on native diffusion-weighted images and high ADC.~      The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with~     whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the~     whole body diffusion-weighted images which can be used as a reference in further studies~     with patients scanned with the same whole body diffusion-weighted imaging scan protocol.~      A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan~     on a 3 Tesla T-MRI system.~      A total scan session will take about 30 minutes. Contrast administration is not required and~     patients will not be exposed to radiation.~   "
139321|NCT01231269|"~     Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique~     that characterizes tissue by probing changes in water diffusion secondary to differences in~     the tissue microstructure. These changes in water diffusion result in differences in signal~     intensity on diffusion-weighted-images that are quantified with the apparent diffusion~     coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be~     diminished, due to the increased number of cells. This will restrict water diffusion,~     identified by increased signal intensity (SI) on native DWI images and low ADC. Several~     studies indicate the value of DWI for differentiation of benign and malignant lymph nodes,~     detection of tumor recurrence and for ADC-based prediction of treatment outcome in various~     solid tumours (Koh DM et al, Am J Roentgenol 2007).~      Patients with a new diagnosis of Hodgkin or Non-Hodgkin Lymphoma (only diffuse large B-cell~     lymphoma, follicular lymphoma, mantle cell lymphoma and PTLD) will be included in the study.~     These patients will receive a WB-DWI scan before treatment, once or twice during treatment~     (depending on the type of lymphoma) and after the completion of the treatment. The MRI scan~     will be performed on a 3 Tesla-MRI system without contrast administration and without~     exposing the patient to radiation.~      Whole body diffusion-weighted images will be prospectively interpreted by two experienced~     radiologists, blinded to all clinical and imaging data. Findings will be correlated to~     FDG-18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose , biopsies performed in clinical~     routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up.~      The purpose of this study is:~        -  to evaluate Whole body diffusion-weighted imaging for staging of lymphoma~        -  to evaluate Whole body diffusion-weighted imaging as an early predictive biomarker for~          treatment outcome~        -  to evaluate Whole body diffusion-weighted imaging for differentiating residual tumor~          from post therapy changes~   "
139322|NCT01231256|"~     A new working method, i.e. a questionnaire completed at home followed by a patient-centred~     preventive health consultation with follow-up, can be used by all general practitioners~     (GPs) as a preventive offer to their patients with multiple problems in lifestyle,~     well-being or health behaviour, if this project is shown to be effective.~      The investigators use a broad preventive offer in a structured way to young adults with~     multiple psychosocial problems (a certain risk profile) found by a screening questionnaire~     when arriving to the clinic.~      The main hypothesis of the project is:~      By using the questionnaire and subsequent patient-centred health consultation the GP is able~     to support the participants to improve their resources, their well-being and self-estimated~     health. Subsequently, relevant changes in health habits and life situation might be~     initiated in order to prevent or reduce future problems or illness.~   "
139323|NCT01231243|"~     There is a controversy in the dentistry literature about how the use of associated light to~     activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the~     bleaching effectiveness. The studies that demonstrated an increased level of bleaching using~     light activation employed lower hydrogen peroxide gels while the ones reporting no~     statistical difference employed higher hydrogen peroxide gels.~      The hypothesis of this study is that the effectiveness of light activation tooth bleaching~     in dependent on the hydrogen peroxide concentration employed.~   "
139324|NCT01231230|"~     The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled~     glucocorticosteroid improves disease control in persistent asthma. This observation has~     supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination~     preparations for the management of asthma. Currently, salmeterol/fluticasone and~     formoterol/budesonide are available for clinical use. The long-term beneficial clinical~     effects of the two drug classes seem to be synergistic, and several mechanisms of~     glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been~     invoked to explain this phenomenon.This study, wish to address the question whether~     glucocorticoids can acutely potentiate the bronchodilator response to a long-acting~     beta-adrenergic agonist.We expect that in patients with asthma, the short-term~     bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by~     itself has no short-term bronchodilator effect. To test this premise, we will assess the~     respective short-term effects of salmeterol (50 µg), fluticasone (250 µg),~     salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway~     Blood flow will also be measured to ensure that vasoconstriction does not occur.~   "
139325|NCT01231217|"~     The purpose of this study is to assess whether green tea or coffee influence the course and~     life quality of patients with mild to moderately active Crohn's disease.~   "
139326|NCT01231204|"~     Research study to determine if putting local anesthetic—or numbing medication—through a tiny~     tube placed next to the nerves that go to a breast prior to and following a mastectomy will~     decrease subsequent pain.~   "
139327|NCT01231191|"~     This is a research study to determine if giving acetaminophen intravenously in hte operating~     room will decrease the number of patients who require additional pain medicine, such as~     morphine, after surgery in the recovery room.~   "
139328|NCT01231178|"~     The project aims to examine the efficacy of a 12-week intake of alginate based ready to~     drink supplement on development in body weight and body composition, and risk markers for~     type-2 diabetes and cardiovascular disease in obese subjects.~   "
139329|NCT01231165|"~     Treatment of coronary artery disease is a major health care problem across the entire word,~     and the United States. Unfortunately, despite a number of medical advances, diagnostic~     procedure, or epidemiological studies, the treatment of these patients remain complex, and~     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United~     States and Canada documented that drug treatment, coronary interventions or both were not~     effective solution in coronary artery diseases.~      A novel approach has recently been developed, based on the critical role of the potassium~     (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by~     hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs,~     whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions.~      This apparently simple mechanisms occurs in human blood in all individuals but could be~     altered in subjects with acquired or hereditable defect in red-blood-cell K content. The~     purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on~     RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic~     changes of myocardial ischemia and electrical regeneration of the heart in subjects with~     coronary artery diseases.~   "
139330|NCT01231152|"~     The aim of the study is to investigate the association of obesity with arterial blood~     pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin~     resistance in children and young adolescents.~   "
139331|NCT01231139|"~     This primary aim is to investigate the effect of paracetamol in reducing body temperature in~     patients who have sustained traumatic brain injury. This study is also investigating the~     safety of paracetamol in this patient population.~   "
139332|NCT01231126|"~     The purpose of this study is to evaluate the blood loss in induced vaginal delivery by~     misoprostol and caesarians section with induction attempt.~   "
139347|NCT01230918|"~     The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI)~     can serve as a marker for scar formation as detected by contrast-enhanced MRI during the~     process of myocardial remodelling after the ischemic insult.~      Comparison of ACS and HCM Populations:~      The primary objective is to determine whether TcNC100692 imaging is able to quantify the~     extent to which myocardial fibrogenesis occurring early post myocardial infarction differs~     from that in patients with hypertrophic cardiomyopathy.~      The primary hypothesis is that since fibrogenesis is known to occur most intensely in the~     first days to weeks post myocardial infarction, while it is a more protracted, less~     predictable process in HCM, there will be significantly more TcNC100692 uptake in the early~     post-ACS population than in the HCM population.~      Control Population:~      Normal control images will allow for differentiation of uptake in the myocardium.~   "
139410|NCT01230060|"~     The objective of this study is to evaluate the safety and effectiveness of the enVista®~     One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the~     visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens~     has been removed by an extracapsular cataract extraction method (eg, small incision~     phacoemulsification).~   "
139333|NCT01231113|"~     Malaria in pregnancy poses enormous public health challenges, contributing to significant~     maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low~     birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility~     to malaria and mediate these adverse outcomes.~      The World Health Organization recommends treatment with artemisinin-combination therapy.~     Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine~     (AS-AQ) and quinine again are used in later trimesters. Recent amendments added~     artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials~     used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in~     several studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible~     and available following its inclusion in the national malaria guidelines and may~     inadvertently be used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in~     pregnancy makes it pertinent to study its safety, tolerability and efficacy in pregnancy.~      We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and~     AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to~     assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include~     PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42,~     prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages~     will be described at 95% Confidence Intervals and compared using chi-square tests.~     Parametric and non-parametric tests of significance will be applied as appropriate to~     determine significance of differences in outcomes between the treatment groups.~   "
139334|NCT01231100|"~     The purpose of this study is to investigate whether or not care guided by hospitalists~     equipped with hand-carried ultrasound echocardiography reduces the length of stay of general~     medicine inpatients who were referred for standard echocardiography.~   "
139335|NCT01231087|"~     Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are~     going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric~     Bypass surgery). They are going to do also body composition analysis in both moments.~      The investigators are going to compare the results to see if the bariatric surgery increases~     their energy expenditure.~   "
139336|NCT01231074|"~     Recent but limited short term studies have shown that Metformin can slow down weight gain in~     obese children and in children with psychotropic-induced weight gain, two distinct pediatric~     populations that are at risk for obesity related co-morbid conditions. The purpose of this~     study is to conduct a long term prospective pilot cohort study to investigate the use of~     Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with~     psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th~     percentile on Metformin. Both study populations will be enrolled in a lifestyle weight~     management program~   "
139337|NCT01231061|"~     Demonstrate the technical feasibility of treating spine metastases with image-guided~     radiosurgery/SBRT~   "
139338|NCT01231035|"~     The main objective of the project is to assess the long-term prognostic impact of residual~     platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with~     acute coronary syndrome undergoing invasive strategy.~      Follow-up length will be at least 24 months. The primary end-point of the study will be a~     composite of death, myocardial infarction, urgent target vessel revascularization, stent~     thrombosis or stroke.~   "
139339|NCT01231022|"~     The investigators want to know the role of Peripheral hematopoietic stem cell infusion in~     avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with~     Drug Induced Liver Injury.~   "
139340|NCT01231009|"~     Aim of present study is to determine whether corticosteroids and vestibular exercises are~     equal effective in the recovery of balance in patients with acute vestibular neuritis.~   "
139341|NCT01230996|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue. Giving cisplatin together with radiation therapy may~     kill more tumor cells.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of cisplatin given~     together with radiation therapy in treating patients with locally advanced cervical cancer.~   "
139342|NCT01230983|"~     RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing~     so they stop growing or die. Combining more than one drug may kill more tumor cells.~     Dexrazoxane may lessen the side effects of chemotherapy.~      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without~     dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic~     leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.~   "
139343|NCT01230970|"~     This trial will assess the intratumoural pharmacological activity of BN83495 by changes in~     intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS)~     activity.~   "
139344|NCT01230957|"~     This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to~     elderly individuals at risk of exposure to Clostridium difficile because of impending~     hospitalization or residence in a care facility.~      Primary Objectives:~        -  To describe the safety profile of subjects in each of the study groups.~        -  To describe the immune responses elicited by toxoid A and toxoid B of subjects in each~          of the study groups.~      Observational Objective:~        -  To describe the occurrence of first-time Clostridium difficile infection (CDI)~          episodes.~   "
139345|NCT01230944|"~     This is a long-term follow-up of a prospective randomized trial comparing open and~     laparoscopic Nissen fundoplication.~   "
139346|NCT01230931|"~     Fractures of the acetabulum are considered rare in the general community, but are quite~     common in major metropolitan areas and tertiary care centers. These fractures are some of~     the most complex and challenging injuries to successfully treat in the orthopaedic field.~     Extensile surgical exposures are required to access this unique structure that comprises the~     cup of the hip joint. Large skin incisions, significant soft tissue dissection, and~     elevation of periosteum and muscle from the intact and fractured fragments are often~     required for anatomic reductions of the acetabulum and good outcomes. Thus, there are many~     sources of intra-operative bleeding that can sum up to require strategies aimed at~     preventing bleeding or replacing blood loss.~      Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of~     cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required~     and cost over $400 per hour. Disposable products are also required for each patient. While~     blood loss can be great, often not enough blood is captured, processed, and available for~     return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is~     often on short supply. The cost of processing, testing, and transfusion is also high:~     minimum of $260 per standard unit of packed red blood cells. While risks of disease~     transmission are rare, they exist and can have serious consequences to patients.~     Transmission can include CMV (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and~     bacteria (1:500,000). Transfusion reactions are more common and include febrile reactions~     (1:100), allergic reactions (1:100), hemolytic reactions (less common), and~     transfusion-related acute lung injury (1:5000).~      Decreased operative times, aggressive electrocautery, ligation of identifiable vessels,~     minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins~     are possible and available. But still, significant blood losses persist. Over the past~     decade, platelet gel products and fibrin sealants have been developed and provide another~     possible solution. There are some retrospective studies in the arthroplasty literature~     indicating these are good hemostatic agents. There is also some literature from the general,~     oral and maxillofacial, and spine surgical fields indicated these topical agents decrease~     intra-operative blood loss. But there are no large prospective, randomized studies in~     orthopedics, particularly traumatology, supporting the use of surgical hemostats.~      This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a~     prospective, randomized controlled trial to evaluate this type of topical agent's role as a~     hemostatic agent in certain acetabular fracture types that require a non-extensile,~     posterior approach. Three fellowship-trained traumatologists will be involved: Drs. Milan~     Sen, Tim Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will~     assist in analyzing the data and statistical outcomes.~      Purpose of Project. The purpose of our study is to determine whether surgical hemostats can~     minimize blood loss, need for allogeneic blood transfusions and their associated risks, and~     costs in patients with certain acetabular fractures requiring operative fixation via a~     non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other~     topical agents like platelet gel products have also been linked with improved wound healing,~     a secondary endpoint will be incidence of wound dehiscence and/or infections.~      The investigators primary hypothesis is the topical hemostat will result in lower blood~     losses intraoperatively and fewer units of perioperative blood product transfused.~   "
139348|NCT01230905|"~     Suppression of effects of androgens with male sex hormones, androgen suppression treatment~     (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There~     have, however, been concerns raised in previous studies that androgen suppression may be~     associated with increased rate of heart attacks, particularly in older men. This study looks~     at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these~     patients with androgen suppression is associated with a decrease in blood flow to the heart~     muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.~   "
139349|NCT01230892|"~     Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner~     lining of blood vessels to release a compound called nitric oxide that can relax blood~     vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric~     oxide and effect additional blood vessel relaxation.~      The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following~     parameters:~        -  Plaque within arteries supplying the heart in terms of its volume and composition as~          assessed by ultrasound within these arteries.~        -  Ability of small arteries in the heart to open up and deliver an enhanced blood supply~          in response to drug called Adenosine (routinely used in the cardiac catheterization~          laboratory) as assessed by pressure and flow detecting catheters within these arteries.~        -  Ability of the inner lining of arteries that supply the heart to release a relaxing~          compound called nitric oxide in response to injection of Acetylcholine (also used in~          the cardiac catheterization laboratory) as assessed by squirting dye into these~          arteries~        -  Local forces that affect blood flow in the arteries supplying the heart as assessed by~          superimposing the above data into complex maps created offline at Georgia Institute of~          Technology.~      It is likely that Nebivolol causes the plaque within arteries supplying the heart to change~     from the 'vulnerable' type to the 'stable' type plaque. There are several features of~     vulnerable plaques that can be detected in arteries of the heart using intravascular~     ultrasound (a small ultrasound camera that goes in the arteries of the heart). The~     investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing~     'vulnerable plaques', improve blood flow within the small arteries and the health of inner~     lining of these arteries at the 1 year time point. The investigators plan to enroll 20~     patients into the study (26 patient including dropouts) who will be randomized in a 1:1~     manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.~   "
139350|NCT01230879|"~     The aim of the study is to investigate the relationship between aging and morphological~     changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for~     this trial.~   "
139351|NCT01230866|"~     The purpose of this study is to compare the effects (good and bad) on patients with prostate~     cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)~     with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of~     the treatments are similar or better.~   "
139352|NCT01230853|"~     The purpose of this study will be to evaluate the safety and tolerability of BAN2401 at~     sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).~   "
139353|NCT01230840|"~     To compare calcium and magnesium absorption within subjects with and without chronic~     consumption of wheat dextrin.~   "
139354|NCT01230827|"~     The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in~     patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with~     active arthritis that have poor response to methotrexate.~   "
139355|NCT01230814|"~     This research study is about vaginal infections such as bacterial vaginosis, yeast~     infections, and trichomoniasis. Usually, these infections can be treated with medication,~     but sometimes they come back after treatment. Researchers want to know if using vaginal~     suppositories can decrease the risk of vaginal infections. Participants will include 234~     women who are sexually active (greater than or equal to 4 episodes of sex with men during~     the past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis~     and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory~     testing at a screening visit. Women will receive vaginal suppositories containing drug or~     inactive ingredients (placebo). Participation in the study will be about 12 months. Study~     procedures include: urine and blood tests, physical exams, and questionnaires.~   "
139356|NCT01230801|"~     A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered~     by intravenous infusion every 2 weeks over a 24-week treatment period to patients with~     late-onset Pompe disease.~   "
139357|NCT01230788|"~     This is a pilot study of a drug called rituximab used together with other drugs—prednisone,~     etoposide, and ifosfamide. Prednisone, etoposide, and ifosfamide have been used as part of~     standard chemotherapy for relapsed Acute Lymphoblastic Leukemia (ALL). Rituximab was~     approved by the Food and Drug Administration in 1997. However, the use of rituximab with~     prednisone, etoposide, and ifosfamide in pediatric patients with relapsed or refractory ALL~     is considered experimental.~      This study is for patients who have ALL in second or greater relapse, or in first relapse~     and not responding to treatment.~      The goals of this study are:~        -  To see if using rituximab with prednisone, etoposide, and ifosfamide is beneficial to~          leukemia treatment~        -  To find out what side effects this combination of drugs can cause~      A total of 15 participants (30 years old or younger) will be enrolled, over a period of 2~     years.~   "
139358|NCT01230775|"~     This is a multicenter, phase III, randomized, subject and sponsor-blinded,~     placebo-controlled study to determine the treatment effect of Anagrelide retard in~     subjects with Essential Thrombocythaemia (ET) at defined risk (definition of risk~     criteria: see Inclusion Criteria Section 5.1) The study is planned as a 2-stage procedure~     according to Bauer and Köhne: After recruitment of 140 subjects an interim analysis with~     re-assessment of sample size is planned in an adaptive manner.~      As the confirmatory analysis will be based on a time-to-event evaluation (i.e. time to 1st~     clinically significant ET related event), there is no stipulated observation time~     identically applying for all subjects. Yet, with an interim analysis being performed after~     having recruited 140 subjects - which is expected to be reached after 1 year - the estimated~     observation time for a subject in stage I will also be about 1 year. (Details are explained~     in the section Statistical Considerations).~      Subjects will be randomized in a 1:1 ratio to one of the following two arms:~      Group A: Anagrelide retard Group B: Placebo~      An a priori stratification is planned for the JAK-2 mutational status. For exploratory~     purposes a post hoc stratification is used for obtaining covariate adjusted results, for the~     following other potentially predictive factors: sex, age, Factor V Leiden, and BMI.~      Dosing will be started with 1 tablet per day for week 1 and will be titrated up according to~     response (platelet reduction) to 2 tablets in week 2. Dosing may be further increased or~     decreased according to platelet response in week 3 and 4. However, the maximum dose is 4~     tablets (=8mg) per day. After week 4, the maximum dose to achieve optimal platelet counts~     (<450 G/L) should be maintained (for visit schedule see study flow chart section IV).~      To verify a treatment response, platelet counts must be evaluated at every visit. The~     platelet count values will be withheld from the subjects for the duration of stage I or~     stage II respectively. The subjects have to agree explicitly to this procedure by signing~     the Informed Consent form.~      This is a patient and sponsor-blinded clinical study. The trial medical is packaged in the~     blinded fashion to keep the patient unaware (blinded) towards the actual treatment group~     they were randomized to. The sponsor functions (including medical monitor, pharmacovigilance~     manager, clinical project manager, trial data manager and trial statistician) with stay~     blinded in the course of the study until the database lock. Randomization scheme will be~     prepared by an independent statistician (not otherwise involved in the study), and will be~     stored securely with no access to it by the sponsor functions mentioned above. The process~     of randomization (provision of the individual drug-allocation information to the subjects)~     will be carried out by a trained staff by Harrison, in adherence to the procedures to keep~     the other blinded functions unaware of this information (blinded). Unblinding envelopes,~     which contain the treatment code per patient number for identification of treatment in case~     when a safety-relevant unblinding needed, will be stored at the sponsor's site. At the end~     of the study, verification of the extent of maintaining the blind by checking if the~     envelopes have been broken, will take place and will be properly documented. If the sealed~     envelope will broken to provide treatment identification, the date of breaking the code, the~     initials of the person who broke the code and the reason will be stated on the envelope.~      The operational details on the blinding procedures are outlined in the relevant working~     guidelines (ARETA Study Working Guideline for idv staff and ARETA Study Working Guideline~     for Harrison, each in its current version).~      Investigator will not be blinded in this study, i.e. in case of a medical need individual~     patient management will be driven by the full knowledge of the trial related interventions.~     For the case, the sponsor will need to unblind a patient (e.g. due to safety reasons), the~     above mentioned (in this section) envelopes will be used.~      Only treatment naïve subjects, in respect to cytoreductive drugs with confirmed diagnosis of~     ET (centralized re-evaluation according to WHO, 2008; see Section 6.2.1) and assessment of~     JAK-2 status (centralized re-evaluation of JAK-2 status; see Section 6.2.2) will be~     enrolled.~      As described above, stage I of the study will be considered as closed as soon as 140~     subjects have been recruited. The duration of stage II depends on the result of the~     re-assessment of sample size.~      Once stage I is finished, stage I subjects will enter into an extension period for a maximum~     of three years.~   "
139359|NCT01230762|"~     The purpose of this study is to evaluate the long-term safety of dapoxetine in men with~     rapid ejaculation.~   "
139360|NCT01230749|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what~     the body does to the medication) and pharmacodynamics (what the medication does to the body)~     of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes~     mellitus participants.~   "
139361|NCT01230736|"~     The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from~     prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination)~     pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.~   "
139362|NCT01230723|"~     The objective of the study is to assess the superiority of the everolimus-eluting stent~     (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding~     uncovered stent strut segments.~   "
139363|NCT01230710|"~     This open-label, single-arm study will evaluate the safety and efficacy of Tarceva~     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who~     have completed 4 cycles of standard platinum-based chemotherapy without progression.~     Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or~     unacceptable toxicity occurs.~   "
139364|NCT01230697|"~     The study includes the recruitment of patients with advanced renal cells carcinoma and~     hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective~     observational study.~   "
139365|NCT01230684|"~     The purpose of the study is to compare two different types of imaging techniques to identify~     endoleaks. Following the endovascular procedure, subjects are seen at one month to have~     computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA~     is the standard imaging technique used to identify endoleaks. This study will investigate if~     the image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a~     good tool to identify endoleaks too.~   "
139411|NCT01230047|"~     This is a quasi-experimental evaluation of psychoeducational course focusing on mindfulness~     and lifestyle changes for depression and anxiety; clients in active treatment group are~     compared to those in a treatment-as-usual wait-list control group. The primary hypothesis is~     that the psychoeducational course will result in lower levels of depression and anxiety as~     compared to the wait-listed treatment-as-usual comparison group.~   "
139366|NCT01230671|"~     Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast~     cancer patients are the most likely to use complementary medicine within the oncologic~     population. Yoga has become especially popular with this group as it promises to improve the~     mind, body and soul holistically. The investigators yoga program specifically focuses on~     rebuilding physical strength, increasing flexibility and reducing the pain and stress~     associated with the post-operative period. This study will examine how yoga can help improve~     the overall quality of life and its effects on the physical well-being of women with breast~     cancer. With positive statistical results, the investigators hope to implement yoga as part~     of their rehabilitation services at the Cedars Breast Clinic.~   "
139367|NCT01230658|"~     The purpose of this study is to assess anti-factor Xa concentrations in patients given~     prophylactic enoxaparin after bariatric surgery.~   "
139368|NCT01230645|"~     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic~     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is~     effective in reducing the inflammation caused by viral infections such as RSV (respiratory~     syncytial virus).~   "
139369|NCT01230632|"~     This study is to compare the effects of high fat overfeeding on metabolic risk factors in~     children born though assisted reproduction technologies (ART) versus children conceived~     naturally (controls). The investigators will utilize state of the ART measures to~     characterize the physiological, endocrine and molecular responses to high fat overfeeding.~      The investigators hypothesize that children conceived following ART will have greater~     responses to high fat dietary challenge and that this will be associated with DNA~     hypermethylation of genes that are involved in lipid metabolism.~   "
139370|NCT01230619|"~     RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic~     rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568~     ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with~     seasonal allergic rhinitis.~   "
139371|NCT01230606|"~     This is a multi-center trial that will evaluate the safety, feasibility, and cost~     effectiveness of discharging patients, who have had successful percutaneous coronary~     intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24~     hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion~     and will have a study population of 600 patients over 6 investigational sites all within the~     United States. Patients <65 years old will be chosen in order to stay within the low risk~     group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit.~     The primary endpoint will be a composite of major adverse cardiac and cerebral events, and~     the incidence of major bleeding or vascular complications. Data acquired from the study,~     such as blinded financial information and patient satisfaction surveys, will be used in~     order to evaluate cost analysis and safety of the procedure.~   "
139372|NCT01230593|"~     An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the~     blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to~     a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months.~     The chalazion may cause tearing, pressure on the cornea, and irritation, all of which~     contribute to its morbidity. There are many anecdotal first line treatments for this~     condition, including warm compresses to the eyelid, topical antibiotics, topical steroids,~     topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical~     trials to compare the efficacy of any of these conservative treatments. We wish to determine~     the most effective conservative medical treatment for chalazia.~   "
139373|NCT01230580|"~     The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is~     non-inferior to continuing triple-therapy, in terms of the proportion of patients who~     maintain all the drug treatment options that were available to them at baseline after at~     least 3 years of follow-up, and to compare clinical events, safety, toxicity and health~     economic parameters between the two strategies.~   "
139374|NCT01230567|"~     50 patients with non healing wounds will undergo biopsy to conclude wether there is an~     occult etiology for the wound.~   "
139375|NCT01230554|"~     The objective of this one week, single group, bilateral, open-label study is to evaluate the~     product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test)~     when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted~     soft contact lens.~   "
139376|NCT01230541|"~     Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects~     on semen characteristics.~   "
139377|NCT01230528|"~     Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms.~     The incidence of RT is different depending on age. Mostly, we reasoned that RT is a~     phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of~     this study was to determine the association of RT and clinical or laboratory characteristics~     in pediatric diseases.~   "
139378|NCT01230515|"~     The purpose of this study is to modify the opioid titration order sheet to meet the needs of~     the outpatient hospice population and to conduct a pilot trial to assess feasibility,~     utility, and derive preliminary efficacy data.~   "
139379|NCT01230502|"~     To determine whether long-term maintenance therapy with a single drug (Myfortic) applied~     using advanced immunologic monitoring tools in selected patients can lead to superior native~     kidney function at 2 years without resulting in increased acute rejection episodes or~     deterioration of liver allograft function.~   "
139380|NCT01230489|"~     To evaluate the efficacy of honey as a post surgical exit site care process to promote~     healing and prevent infectious bacterial colonization of newly created exit sites. It has~     been shown in the medical literature that honey has properties that are conducive to healing~     and the prevention of infection. In one study it was demonstrated that in urethral injury in~     the rat treated with honey the injury healed with none of the usual formation of fibrous~     tissue seen in such healing processes, that there was no reduction in the luminal diameter~     usually seen, and that the cells lining the urethra were uncompromised in any way, i.e.~     totally normal and healthy. We feel that if an exit site can be healed quickly with good~     normal tissue being developed that the patient will have a much better chance to keep that~     exit healthy reducing time, cost, and disruption of lifestyle. Other positive aspects of~     honey are it has the low pH required for good healthy tissue healing, it works in the~     presence of wound fluids, and it has never been shown to produce a resistant bacterial~     strain.~   "
139384|NCT01230437|"~     The airways of the lung are lined by specialised cells called airway epithelial cells. As~     well as being at the interface between the lungs and the air we breathe; airway epithelial~     cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC~     secrete many mediators that contribute to asthma symptoms and these also contribute to~     asthmatic inflammation in the lungs. The study of such cells is difficult because of their~     location deep in the lungs. Nasal airway epithelial cells provide a useful and easily~     accessible model of model of lower airway cells. This study will examine whether the asthma~     medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of~     asthmatic patents who also have allergic rhinitis compared with patients who have asthma~     alone. We will also examine if montelukast has differential modulating effects in these two~     patient groups.~   "
139385|NCT01230424|"~     A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized~     placebo-controlled clinical trial testing the effect of this steroid versus placebo given~     into the study knee joint that has osteoarthritis (OA). The knee injection will be given~     once every 12 weeks over two years for a total of eight knee injections. How well each~     participant tolerates each injection and all the injections over time will be assessed. The~     safety of getting a knee injection every 12 weeks will be assessed by collecting reported~     adverse effects, knee examinations, and clinical laboratory tests. Participants will~     complete questionnaires, X-ray, MRIs, and bone density tests as part of this study.~   "
139386|NCT01230411|"~     This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the~     treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in~     subjects who are treated with study medication between 2 and 72 hours from time of onset of~     headache.~      Periodic safety and efficacy assessments will be performed prior to and after study drug~     administration.~      Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment~     groups (active treatment and placebo) who have pain relief at 2 hours after the completion~     of the double-blind treatment infusion. Pain relief is defined as a reduction in headache~     pain level from severe or moderate decreased to mild or headache-free, respectively.~   "
139387|NCT01230385|"~     Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate~     the safety and toleration of 2 different doses of lersivirine administered either fed or~     fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD~     (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be~     evaluated.~   "
139388|NCT01230359|"~     Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial~     effects in patients with autism spectrum disorders (ASD). The underlying theory for these~     effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle,~     will be more balanced. Most studies have been focused on the clinical outcome with this~     treatment. The present proposal will examine the effects on the different intermediates of~     the methionine cycle (methylation and transulfuration capacity), suggested to play an~     important role for the pathogenesis of ASD. The design is a prospective pilot study,~     including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive~     the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design.~     Metabolites in blood and urine will be measured prior to and at the end of the treatments in~     the different groups. The results will then provide us with information, which will link~     clinical outcomes with biological markers. Furthermore, the study has also the potential to~     shed light on the pathogenesis of ASD.~   "
139389|NCT01230346|"~     This pilot clinical trial studies a culturally-informed counseling intervention in Latinas~     at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling~     intervention may be an effective method to help people learn more about their cancer risk.~   "
139390|NCT01230320|"~     BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex~     technical procedures. Those procedures include two impressions for each jaw, the~     registration of the relationship between the upper teeth and the patient's head and usually~     two appointments for tooth try-in. However, recent studies have questioned the real need for~     such complex procedures. Simplified methods could have similar results if compared with~     conventional ones, and dentures would be delivered faster and with lower costs.~      OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a~     simplified or conventional method.~      METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular~     complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão~     Preto Dental School will be randomly divided into two groups. Group S will receive new~     dentures fabricated by a simplified method, whereas Group C will received new dentures~     according to a conventional method. Participants will complete a questionnaire for denture~     satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At~     the same time, a specialist in dental prostheses will evaluate the quality of new dentures.~   "
139391|NCT01230307|"~     The central objective of this proposal is to establish that vitamin D supplementation in~     heart failure patients with low vitamin D levels will have improved outcomes compared to~     placebo. In addition the investigators will also evaluate the role of genetics in regard to~     vitamin D and heart failure. The investigators will be evaluating what is currently a novel~     approach of identifying patients with low vitamin D and treating this low vitamin D level.~     The investigators will be able to evaluate the importance of vitamin D supplementation in~     these patients and the role of genetics on our defined outcomes.~   "
139392|NCT01230294|"~     Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and~     strain-echocardiography) for measurement of the right ventricular (RV) function .~   "
139393|NCT01230281|"~     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after~     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma~     concentration of C3G and the antioxidative markers such as total antioxidative capacity and~     attack of free oxygen radical will be measured.~      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg~     black bean seed coat extract.~      This study, as an exploratory trial, does not required statistical hypothesis~   "
139456|NCT01229462|"~     This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed~     combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in~     patients with glaucoma or ocular hypertension who do not respond well to topical beta~     blockers.~   "
139394|NCT01230268|"~     This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after~     administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma~     concentration of C3G and the antioxidative markers such as total antioxidative capacity and~     attack of free oxygen radical will be measured.~      Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg~     Mulberry fruit extract.~      This study, as an exploratory trial, does not required statistical hypothesis.~   "
139395|NCT01230255|"~     Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have~     traditionally been treated surgically through emergent laparotomy. Intensivist-performed~     bedside drainage of free intra-peritoneal fluid or blood [percutaneous catheter~     decompression (PCD)] has been suggested as a less-invasive alternative to traditional open~     abdominal decompression (OAD). This study assesses the relative efficacy of PCD vs. OAD in~     reducing elevated intra-abdominal pressure (IAP).~   "
139396|NCT01230242|"~     This study aims to demonstrate that the expulsion rate is increased but acceptable when~     inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The~     investigators will compare the postplacental insertion expulsion rate estimate with rates~     reported in the literature for 6 week postpartum insertion, which is currently the American~     standard for IUD insertion postpartum. Secondary outcomes will also be examined;~     endometritis, uterine perforation, continuation and pregnancy among others.~   "
139397|NCT01230229|"~     The aim of this study is to evaluate whether primary stenting with self expanding stent in~     patients with peripheral arterial disease suffering from stable claudication due to~     superficial femoral artery disease results in improved patient outcomes, compared to~     conservative treatment alone as measured by improvement in Quality of Life scores at 12~     months after treatment using established surveys. Patients will be followed up 24 months~     after treatment. Planned recruitment and randomization of 100 patients was completed June~     2015.~   "
139398|NCT01230216|"~     The purpose of this study is to evaluate the effect of intensive blood pressure control~     compared to standard blood pressure control on progression of coronary atherosclerosis by~     intravascular ultrasound in hypertensive patients with coronary artery disease.~   "
139399|NCT01230203|"~     Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for~     computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an~     alternative to CTA-based surveillance. The investigators compared CTA with DU during~     endovascular aneurysm repair (EVAR) follow-up.~      Patients undergoing EVAR have radiological follow-up data entered in a prospectively~     multicenter database. The gold standard test for endoleak detection was CTA. DU~     interpretation was performed independently of CTA and vice versa.~   "
139400|NCT01230190|"~     To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD~     in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting~     and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in~     young children (beyond the conventional treatment).~   "
139401|NCT01230177|"~     This survey is conducted to investigate safety and efficacy under the post marketed drug~     utilization on the patient with rheumatoid arthritis (only for patients with an inadequate~     response to prior conventional therapy) at the time of switching regimen from 10 mg twice a~     week administration to 25 mg once a week administration.~   "
139402|NCT01230164|"~     An aberrometer measures visual aberrations by mapping how light rays travel through the eye~     and by providing maps using colored gradients to represent the magnitude of refractive~     errors of the eye.~      The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx~     Technology), Zywave (Bausch & Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer~     (Alcon Inc). In particular, the investigators propose to focus on the ability of these~     devices to display the higher order visual aberrations and to compare the quality of outputs~     from these 4 devices in normal healthy subjects.~   "
139403|NCT01230151|"~     The purpose of this study is to assess the cognitive performance in patients with advanced~     Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined~     clinically to settings derived from a patient-specific computational model.~   "
139404|NCT01230138|"~     The purpose of this trial is to investigate the efficacy and safety of different doses and~     dose administrations of FP187 compared to a placebo treatment in patients with moderate to~     severe plaque psoriasis.~   "
139405|NCT01230125|"~     The objective of this clinical study is to compare the safety and efficacy of Mapracorat~     Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and~     pain following cataract surgery.~   "
139406|NCT01230112|"~     Study to examine the role of ITGAM molecule in normal control subjects with known genetic~     variation in the ITGAM gene.~   "
139407|NCT01230099|"~     The purpose of this study is to test a communication intervention to support family~     decision-making for patients with chronic critical illness.~   "
139408|NCT01230086|"~     Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary~     and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for~     sensing and defibrillation capabilities of the ICD system is performed. Modern implantation~     strategies suggest a non-testing approach because net-benefit of a testing versus a~     non-testing strategy is questionable and because arrhythmia induction and defibrillation may~     cause micro damage to the heart.~      The study aims to investigate the contribution of different steps in the ICD implantation~     procedure (implantation of the lead, shock delivery and induced ventricular fibrillation)~     with respect to their potential damage to the heart measured by high sensitivity (HS)~     TroponinT.~   "
139409|NCT01230073|"~     Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new~     development in ICD therapy and has been shown to be technically feasible and safe.While data~     on safety and feasibility of remote monitoring are in favour of this technology, patients´~     treatment satisfaction has not been sufficiently investigated. To date, there is only one~     small, non-randomised study investigating patients´ treatment satisfaction in highly~     selected and highly motivated patients at the time of implantation and 12 months~     thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are~     associated with patients´ willingness to accept the new method of follow-up on a broad basis~     of ICD recipients and to determine their treatment satisfaction with ICD therapy in a~     randomised, prospective trial.~   "
139412|NCT01230034|"~     Numerous clinical and experimental data show that the elective treatment of diabetic~     nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS).~     Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients~     with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the~     renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists~     II have proven effective in reducing proteinuria in power even if different therapeutic drug~     to drug. ACE inhibitors are one of the most known and used treatment options for blocking~     the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril,~     lisinopril and ramipril are standard therapy in diabetic patients with micro or~     macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of~     view, the same or varies from drug to drug. This is particularly true in the diabetic~     microalbuminuria, a condition in which there is sufficient documentation to prove that~     ramipril is effective. The main objective of this study was to assess the magnitude and~     trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die~     imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and~     microalbuminuria.~   "
139413|NCT01230021|"~     This trial is conducted in Europe and United States of America (USA). The aim of this~     clinical trial is to investigate the pharmacokinetics (at which rate the substance is~     distributed and eliminated from the body) and the safety profile of catridecacog~     (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency.~     Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.~   "
139414|NCT01230008|"~     The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in~     diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy~     in patients treated with R-CHOP~   "
139415|NCT01229995|"~     CAD/CAM technology has been introduced to the field of implant dentistry in the beginning of~     1990's (Priest 2005). Since their introduction, the use of CAD/CAM technology in the~     production of dental implant restorations has been rapidly expanding. However, little~     evidence is currently present supporting its clinical viability (Henriksson 2003, Canullo~     2007).~      Therefore, the suggested prospective randomized study includes bone level placed Straumann~     implants restored with transmucosal elements and crowns fabricated using either CAD/CAM~     Etkon technology (Zirconia abutment and ceramic crown) or a conventional technique~     (Crossfit titanium abutment and a ceramometal crown).~      The aim of this randomized controlled clinical trial is to examine single-tooth implant~     restorations in the esthetic zone. An esthetic area is defined as any area that is visible~     in the patient's full smile. [3rd ITI consensus conference 2004] The rehabilitations will be~     fabricated using two different techniques. Zirconia CAD/CAM (ZCC) implant restorations~     (tests) will be compared to Titanium conventionally-fabricated (TCF) implant restorations~     (controls) using, reproducible esthetic (objective/subjective) and biologic parameters.~      This in vivo study is a randomized study with two groups of 15 patients with one implant~     each for a total of 30 patients and 30 implants. The implants will be examined for~     successful tissue integration according to the criteria of success (Buser et al. 1990) at~     every recall visit.~      In addition, the following parameters will be evaluated for each restoration:~        -  Esthetic: A. Objective: PES/WES Score (Belser et al. 2009) from 1:1 digital photograph,~          study casts, and spectrophotometric measurements, and B. Subjective: VAS questionnaire~          for patients and VAS questionnaire from experts.~        -  Biologic (mPI, mB, simplified GI, microbial sample, periapical radiograph for DIB, and~          width of keratinized facial mucosa)~      Finally, an evaluation of the mechanical, biologic and technical complications will be~     performed at every recall visit. Mechanical complications would be defined as those~     complications that involve the prosthesis such as abutment screw loosening, fracture of the~     veneer material, fracture of the crown framework, abutment screw fractures, and implant~     fractures. The category of biologic complications will include those complications that~     involve the soft tissues (e.g., fistula, suppuration, bleeding, gingival inflammation, and~     soft tissue dehiscence). Technical complications are defined as those related to restorative~     components and crowns (e.g. crown emergence profile, abutment and crown fit, screw~     loosening, ceramic fracture).~   "
139416|NCT01229982|"~     The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure~     in subjects with ocular hypertension or open-angle glaucoma.~   "
139417|NCT01229969|"~     Accidental falls in older adults are highly prevalent and a major source of morbidity. Over~     30% of people aged 65 or older fall each year with about half of these cases being~     recurrent. Falls may result in head trauma, bone fractures, and even death and are leading~     cause of both nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite~     of exercise and fitness video games using a balance board periphery developed for the Wii~     console. The purpose of this study is to determine the feasibility and validity of the~     Nintendo Wii Fit, in detecting balance problems in older community dwelling adults.20~     ambulatory older adults will be recruited to participate in this study.Subject will be asked~     to complete 1 study visit. In this visit information will be gathered about the subjects~     overall health including fall assessments. Qualified subjects will be randomized into two~     study groups where one group will begin the study with Wii Fit testing followed by NeuroCom~     EquiTest evaluation and the other group in reversed order.~   "
139418|NCT01229956|"~     RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help~     doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from young patients~     with acute myeloid leukemia.~   "
139419|NCT01229943|"~     This randomized phase II trial studies how well everolimus and octreotide acetate with or~     without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that~     cannot be removed by surgery and have spread nearby or to other places in the body.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells.~     Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to~     grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic~     neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether~     giving everolimus and octreotide acetate together is more effective with or without~     bevacizumab in treating pancreatic neuroendocrine tumors.~   "
139420|NCT01229930|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known~     whether carboplatin and paclitaxel are more effective when given with or without cediranib~     maleate in treating patients with cervical cancer that cannot be removed by surgery.~      PURPOSE: This randomized phase II trial is studying giving carboplatin and paclitaxel~     together with cediranib maleate to see how well it works compared with giving carboplatin~     and paclitaxel together with a placebo in treating patients with metastatic or recurrent~     cervical cancer that cannot be removed by surgery.~   "
139421|NCT01229917|"~     The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus~     rhamnosus GG during rhinovirus infection.~   "
139422|NCT01229904|"~     Post traumatic Stress disorder (PTSD) is a common condition for persons who have served in~     the Armed services during combat or deployment. Treatments include medications, cognitive~     behavioral therapy, and other social support mechanisms.~      Our aim in this project is to critically evaluate the effects of a novel music therapy~     intervention on the symptoms of PTSD. Estimates developed by the Global Burden of Disease~     Study reveal that mental illness accounts for over 15% of the burden of disease on health~     and productivity in established market economies--more than the disease burden caused by all~     cancers combined.[1] Perhaps no industry has had the burden of mental disorders affect its~     labor force as severely and pervasively as the Armed Forces.~      Post-Traumatic Stress Disorder (PTSD) is a common sequelae of severe emotional trauma that~     is often associated with combat exposure. The condition has been well documented in~     returning soldiers and is characterized by recurrent and distressing thoughts and feelings~     related to the trauma, persistent avoidance of reminders of the trauma, and increased~     arousal that disturbs sleep, concentration, and the ability to modulate anger. Persons~     suffering from PTSD often have difficulty relating to others, leading to loneliness and~     isolation, which further intensifies their psychiatric symptoms. Current treatment options~     for PTSD include psychotherapy, medication management, or a combination of those. Although~     these treatments have been shown to be effective, returning soldiers are often hesitant to~     seek and adhere to mental health therapies. PTSD-related avoidance, including difficulty~     trusting, may serve as a barrier to seeking or completing treatments. Furthermore, some PTSD~     medications have unacceptable side-effects in some individuals. The need is great,~     therefore, to identify and promote safe, effective strategies for self-management of PTSD~     among Veterans.~   "
139423|NCT01229891|"~     The aim of this study is to evaluate the possible effects of daily intake of yogurt drink~     fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic,~     metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes~     (T2DM).~   "
139424|NCT01229878|"~     This is a double-blind placebo controlled pilot study to determine if vitamin D~     supplementation in hemodialysis (HD) patients will improve physical function and cognition.~     HD patients have a high prevalence of vitamin D deficiency, cognitive impairment, and~     physical impairment. Despite standard clinical care with active IV vitamin D during~     dialysis, HD patients still have markedly low levels of nutritional or dietary vitamin D. IV~     treatment with vitamin D during dialysis is aimed at treating HD related bone disease.~     Recent literature shows that oral or nutritional vitamin D has multiple extra-skeletal~     effects including improvement in cognition and physical function. In this study, the~     investigators plan to administer oral vitamin D to vitamin D deficient HD patients already~     receiving standard care with IV vitamin D therapy. Patients will be randomized to receive~     either placebo or 50,000 IU of vitamin D (cholecalciferol) weekly for 6 months. The~     investigators' specific aims are to 1) Assess the benefits of correcting nutritional vitamin~     D deficiency on cognitive and physical function in HD patients receiving routine standard of~     care, 2) Assess the feasibility of recruiting HD patients for this study, and 3) Evaluate~     the proposed regimen for safely and effectively increasing nutritional vitamin D levels with~     oral supplementation. The investigators anticipate that correction of nutritional vitamin D~     deficiency to optimal levels will improve the high prevalence of cognitive impairment and~     physical impairment in this population. These results will be used as evidence to support a~     larger study aimed at treating nutritional vitamin D deficiency in all patients receiving~     HD. These results may also contribute to a change in current guidelines which place little~     emphasis on the monitoring and treatment of nutritional vitamin D levels in HD patients.~     These results are important for the Veteran dialysis population since many of them are~     required to perform high-level cognitive tasks such as management of complex medical~     regimens and physical tasks such as orchestrating independent transportation to and from HD~     sessions and multiple physician appointments.~   "
139425|NCT01229865|"~     The purpose of this study is to examine the safety and evaluate the response of VB-111 on~     DTC.~   "
139426|NCT01229852|"~     Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic~     stimulation technology which may provide a drug-free method for treating fibromyalgia.~      The purpose of this study is to determine the effectiveness and the durability of effect of~     Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women~     diagnosed with fibromyalgia.~   "
139427|NCT01229839|"~     TACE is considered the standard treatment for unresectable HCC on the basis of the fact that~     there are no alternative to curative procedures.But the optimal combined regimen is still~     unclear. One of the controversy is do the protocol should contain lipiodo and how to~     executer. The investigators hypothesize that TACE without mixing the chemotherapy with~     lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.~   "
139428|NCT01229826|"~     The purpose of this study is to gain additional information regarding use of Magnetic~     Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the~     investigators will use a new noninvasive technology, MRE, to further characterize the~     elastic properties of the uterine fibroids. To date, very little is known concerning how the~     tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance~     Guided Focused Ultrasound (MRgFUS).~      In this study, the investigators will use a new noninvasive technology, magnetic resonance~     elastography (MRE), to further characterize the elastic properties of the uterine fibroids.~     This information will be gathered during routine magnetic resonance imaging for symptomatic~     uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic~     Resonance Imaging(MRI) can be more difficult to treat.~      This information will be gathered during routine magnetic resonance imaging for symptomatic~     uterine fibroids.~   "
139429|NCT01229813|"~     Patients with metastatic colorectal cancer will be treated with chemotherapy according to~     investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will~     be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the~     patients KRAS status will be tested. After having fulfilled these 18 weeks of induction~     treatment, patients who has responded (complete response/partial response versus stable~     disease) will be randomized to maintenance treatment. Patients with KRAS WT will be~     randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS~     mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational~     research is performed, with purpose to find predictive factors in blood and tumor tissue.~   "
139457|NCT01229449|"~     The objective is to assess the efficacy and tolerability of a combination of 400 mg~     ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg, acetaminophen compared~     with a combination of 400 mg ibuprofen plus 25.6 mg codeine (Nurofen Plus®) and a~     combination of 1000 mg acetaminophen plus 30 mg codeine (Panadeine® Extra) in terms of total~     analgesic effect, peak analgesic effect, onset and duration of action and the subject's~     overall assessment of the study medication.~   "
139458|NCT01229436|"~     This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the~     affected fingers and the patient and physician reported treatment satisfaction and disease~     severity and their relation to ROM. Recovery to normal activities, recovery time (How long~     overall, time to use hand, time to return to work or daily activities, amount of work or~     daily activity time missed or reduced and affects on productivity and daily activities) will~     be assessed via patient diary. Use of concomitant analgesic medications will be recorded and~     total healthcare resource utilization (HCRU).~   "
139459|NCT01229423|"~     This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the~     augmentation of eyelashes in Korean women.~   "
139430|NCT01229800|"~     : In several studies comparing of sodium phosphate solutions versus PEG, both regimen had~     similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to~     patients because patient are required to consume smaller volume. But sodium phosphate~     solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate~     solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid~     peroral approach to colon lavage without causing fluid and electrolyte disturbance. However,~     the need to ingest a large volume of fluid reduces patient compliance, and results in~     suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved~     that split dose of PEG regimens were better quality preparation and more acceptable than~     single dose regimens. In Korea, need for outpatient or screening colonoscopy without~     laboratory test is increasing and split dose of PEG is used more frequently than other~     country in bowel preparation because of safety. But, superiority of split dose of PEG to~     sodium phosphate solution has not been demonstrated. The study was not yet existed about~     comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and~     tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with~     medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to~     sodium phosphate solutions provide a better colon cleansing efficacy and similar~     tolerability.~   "
139431|NCT01229787|"~     Obesity has been recognized as a risk factors for developing asthma. In a cohort of 5384~     children aged 15-17, we aim to:~        1. To investigate the association of asthma prevalence at age 15-17 with body mass index~          (BMI) at age 15-17 and BMI at age 11-12 years Part II~        2. To investigate the association of BMI in adolescence and BMI at age 11-12 years with:~             1. Prevalence of allergic sensitization~             2. Lung function~             3. Levels of airway inflammation at age 16-18 years~             4. Severity of asthma~      Secondly, to assess diet and physical activity involvement as effect modifiers in these~     possible associations.~   "
139432|NCT01229774|"~     The primary aim of this study is to test if etoricoxib decreases the perioperative blood~     loss compared to diclofenac.~      Secondary questions to be explored are:~        -  Does etoricoxib prevent Heterotopic ossification after Total Hip Arthroplasty as well~          as diclofenac ?~        -  Do diclofenac and etoricoxib both reduce pain at rest and on movements?~        -  Does etoricoxib compared to diclofenac reduce the amount of rescue medication~          (Oxycodon)?~        -  Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?~   "
139433|NCT01229761|"~     The purpose of this study is to find ways to improve infant health and survival among~     infants whose mothers are HIV-infected but who do not themselves have HIV.~   "
139434|NCT01229748|"~     The investigators propose a randomized controlled trial with five aims: 1. To investigate~     the engagement potential and effectiveness of a family-centered intervention (MDFT) and~     Family Motivational Interviewing Intervention (FMII)/group for teens with alcohol-related~     crises; 2. To explore differential treatment effects with comorbid adolescents; 3. To~     examine the role of motivation and family factors as treatment mediators; 4. To examine~     long-term abstinence, patterns and predictors of relapse up to 18 months follow-up; and 5.~     To compare the total and net monetary benefits to society of MDFT, FMII/group, and standard~     care.~   "
139435|NCT01229735|"~     To assess the long-term effects of levetiracetam on retention rate in subjects with~     refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant~     antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.~   "
139436|NCT01229722|"~     The main aim of this phase II proposal is to continue and complete development of a cellular~     phone-based system that assists patients with their medication adherence. Adherence reports~     will be developed with feedback from patients and providers. Software for patients to report~     their four day recall adherence through text messaging or short message service (SMS) or~     interactive voice response (IVR) will be built. An initial qualitative study will evaluate~     the adherence reports, 4-day adherence recalls, and inform the development of content for~     reminder text messages that could be resistant to user fatigue. A redesigned system will be~     tested through a 3-week longitudinal study of 15 patients with human immunodeficiency~     virus/acquired immunodeficiency syndrome (HIV/AIDS). An intervention module will have an~     analytics engine to track adherence levels and personalize delivery of reminder messages. A~     clinic appointment module will perform patient appointment reminders. The final system with~     these modules will be tested through a 24-week efficacy study. A total of 115 patients and~     providers will be involved in the three user studies.~   "
139437|NCT01229709|"~     This study is a randomized, controlled trial of Mindfulness Based Tinnitus Reduction (MBTR)~     vs. Treatment As Usual (TAU). This study aims to determine patient's benefit from~     participating in an 8-week MBTR program as measured by a reduction in clinical symptoms, if~     present, and a tinnitus symptom perception shift. Sixty-four tinnitus patients who have~     previously received Tinnitus Counseling (TAU) at the UCSF Audiology Clinic under the~     direction of Robert Sweetow, PhD will be invited to participate in the MBTR study. Subjects~     will be randomly assigned to the experimental and control groups of 32 each. All subjects~     will have received Tinnitus Counseling at least 6-months prior to entry into the study.~     Tinnitus symptom activity and discomfort as well as psychological outcomes will be assessed~     by self-report questionnaires. The primary outcome measure is the Tinnitus Handicap~     Inventory (THI) measuring tinnitus symptom severity. The secondary outcome measures include~     the Tinnitus Visual Analogue Scale (TVAS), the Symptom Checklist-90-Revised (SCL-90-R),~     Hamilton Anxiety and Depression Scale (HADS), and the Five Factor Mindfulness Questionnaire~     (FFMQ). In addition to tinnitus symptom severity, secondary outcome measures are used to~     measure change in mindfulness and other clinical symptoms such as anxiety and depression, if~     they exist. The experimental group will complete measures at pre-, post-, at 3-months and~     12-months follow-up. A 12-month follow-up assessment will be conducted with the experimental~     group to identify any enduring effects of the treatment. The control group will fill out~     measures at pre-, post-, and 3-month time periods. The 12-month follow-up will be conducted~     with the experimental group only and will be the uncontrolled portion of the study.~      The purpose of this study is to 1) Design and execute an MBTR program for patients with~     tinnitus within the UCSF Department of Audiology. 2) Determine patient's benefit from~     participating in an 8-week MBTR program as measured by a decrease in tinnitus distress, and~     a reduction in clinical symptoms (i.e., depression, anxiety), if present. 3) Compare the~     responses on study measures to those of the control group. 4) Collect follow-up data at 6-~     and 12-months post intervention to assess enduring effects, if any, in the experimental~     group. 5) Use the data and patient feedback to modify UCSF's Audiology program and guide~     future programming in regards to the treatment and care of patients with tinnitus.~   "
139438|NCT01229696|"~     Research study to determine the relationship between perineural catheter tip location~     relative to the sciatic nerve bifurcation and postoperative analgesia for continuous~     popliteal nerve blocks.~   "
139439|NCT01229683|"~     Research study to determine the proportion of cases in which an interscalene brachial plexus~     nerve block produces hand and forearm anesthesia.~   "
139460|NCT01229410|"~     This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal~     administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery~     System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.~   "
139440|NCT01229670|"~     Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the~     end result of many cardiovascular disorders. It has been reported that HF patients with~     pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise~     tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is~     associated with neurohumoral changes as the body attempts to reverse the effect of reduced~     cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually~     results in deterioration of myocardial function with inflammatory response, end-organ~     damage, and skeletal muscle derangement, which lead to worsened exercise capacity.~      Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and~     central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular~     function, leading to improvement in functional capacity and quality of life. All these~     training-induced changes can effectively counteract the progression of deleterious~     compensatory mechanisms of HF.~      Several lines of evidence suggest greater aerobic and cardiovascular adaptations after~     high-intensity exercise than with moderate levels in patients with coronary artery disease~     or left ventricular dysfunction function and in healthy subjects. Aerobic interval training~     (AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte~     contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial~     natriuretic peptide in animal model of post-infarction heart failure. However, underlying~     mechanisms of AIT-improved regulations remain unclear.~      The different effects of AIT and moderate continuous training (MCT) on hemorheology,~     atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with~     CHF have been not investigated yet. Accordingly, the investigators will conduct this~     three-year study to clarify how the two exercise trainings affect cardiovascular~     hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in~     patients with chronic heart failure. The investigators expect that these results obtained~     from this study can aid in determining appropriate exercise intervention to improve aerobic~     fitness as well as simultaneously improve hemodynamic control and minimize the risk of~     thrombogenesis in patients with CHF.~   "
139441|NCT01229657|"~     To evaluate the anatomic and visual outcomes in patients with initially closed macular holes~     after vitreoretinal surgery and with one to seven years of follow-up.~   "
139442|NCT01229644|"~     The purpose of this study is to evaluate the antitumor efficacy of crenolanib (CP-868,596)~     in patients with recurrent high grade glioma and in patients with low grade glioma.~   "
139443|NCT01229631|"~     The objective of this study is to determine whether enhanced micronutrient intake in the~     form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical~     outcomes in chronic periodontitis patients prior to standard non-surgical treatment.~   "
139444|NCT01229618|"~     Current imaging options do not assess prostate cancer well. This study will combine two~     magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to~     physicians and patients with prostate cancer in making treatment decisions and seeing how~     well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational~     product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate~     will be injected into the body to determine how it is metabolized and how it's metabolism~     can be assessed using MR imaging.~      The purpose of this study is to determine the safety and metabolism of hyperpolarized~     pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging~     with regards to patient care.~   "
139445|NCT01229605|"~     The standard therapy for patients who have locally advanced breast cancer is to receive~     chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy~     (NAC). Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow~     for a smaller portion of the breast to be removed. Receiving chemotherapy before surgery may~     sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy~     prior to surgery may also control any hidden metastatic disease and thereby decrease the~     risk of cancer relapse. Pre-surgery chemotherapy is a standard management approach for~     locally advanced breast cancer.~      Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The~     purpose of this study is to determine if using a chemotherapy regimen of TC is effective way~     to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before~     surgery. The investigators also hope this study will help us to better understand how the~     tumor tissue is affected by this combination of chemotherapy drugs.~      The TC drug combination is FDA approved for use in treating breast cancer, and it has been~     shown to be equally effective as other commonly used chemotherapy regimens when used after~     surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for~     use before surgery. The investigators will be studying the combination of TC used before~     surgery as a means of possibly shrinking the tumor.~   "
139446|NCT01229592|"~     In recent years, several new methods for treatment of catheter-related bloodstream~     infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with~     variable success [1-10].~      Long-term tunnelled central venous catheters provide a reliable access for administration of~     chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of~     complications such as bacteremia. The need to preserve these intra-vascular devices as long~     as is possible in patients in whom conventional treatment was failed makes emerge antibiotic~     lock-technique.~      Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been~     published using the ethanol lock-therapy as a prophylactic therapy in catheter related~     infections, neither her application in short-term CVCs.~      Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of~     non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit~     (HPSICU).~      Methods: An academic, prospective, randomized and controlled clinical trial is proposed.~     Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms~     (ethanol-lock or control group with conventional measurements such as anticoagulants). In~     the follow-up period, we will register all necessary data to evaluate the end-points of~     study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and~     adverse events due to ethanol).~   "
139461|NCT01229397|"~     The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL~     2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA~     guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60~     years) as reference.~   "
139531|NCT01228487|"~     The important role of mechanical joint stress for the insert and progress of osteoarthritis~     (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by~     unphysiological load of a healthy joint or physiological load of a damaged joint. The exact~     mechanisms leading from increased weight bearing and overuse to cartilage degeneration are~     mostly unknown.~      The hypothesis of the study is that parameters of oxidative stress in the joint synovial~     space reflect damages possibly leading to OA. These parameters correlate with parameters of~     oxidative stress in the peripheral blood. Aim of the study is the identification of such~     non- invasive obtainable biomarkers which represent the degenerative and regenerative~     changes in joint.~   "
139447|NCT01229579|"~     Pakistan is one of the 4 developing countries where cases of poliomyelitis are still being~     identified. Despite the incessant efforts by WHO and UNICEF, this disease is far from~     control. There is a need to develop new and innovative strategies to contain the disease and~     eradicate it from the countries where new cases continue to be identified.~      Zinc is an essential component of scores of enzymes in the human body. Recent reports have~     indicated that this trace element along with other micronutrients enhances the protective~     functions of immune cells. Moreover, zinc deficiency leads to dysregulation of balanced host~     responses to infection resulting into decreased antibody production and suppressed immunity.~     Zinc is also an essential cofactor for thymulin which is known to modulate cytokine release~     and induce immune cell proliferation. Zinc deficiency is also found to impair an~     individual's epithelial barrier function, which may further depress the vaccine entry into~     the mucosal cells.~      Role of zinc in the prevention of diarrheal diseases and other infections in children is~     well documented. However, there are very few reports about its contribution to enhanced~     immunity by supporting body's natural defense system.~      Zinc insufficiency is widespread in socioeconomically deprived children in South Asia and~     the recent most national nutrition survey (2003) . Moreover, diarrhea is also very common in~     infants in Pakistan. Such diarrheal episodes can limit entry of attenuated polio virus into~     the mucosal cells, thereby, leading to inadequate immune response. Association between~     recent diarrheal history and increased vaccine failure in infants has been shown in a study~     from Brazil. The recent Lancet Nutrition series has also recommended regular zinc~     supplementation to address child undernutrition and stunting and underscored the need to~     treat diarrheal episodes with zinc to expedite recovery. Other recent studies of zinc~     supplementation in low birth weight infants in South Asia have also shown significant~     improvement in diarrheal disease burden and mortality.~      On the basis of these lines of evidence, it is possible that some of the cases of vaccine~     failure in this region could be a consequence of compromised immunity and, hence, diminished~     response to OPV. This could potentially be reversed by addressing such gross undernutrition~     and micronutrient deficiencies. It can thus be hypothesized that zinc supplementation at~     community scale would enhance the immune response in infants to OPV.~      In order to test this research question, the investigators propose to undertake 12-month~     randomized controlled trial among a cohort of Pakistani infants of 0-14 days of age. Such a~     trial would enable us to understand the synergistic role of zinc (if any) with OPV in~     enhancing immune response against polio and sero-conversion rates.~   "
139448|NCT01229566|"~     The primary objective is to determine the efficacy of AKR963 compared to placebo and active~     comparator in lowering fasting triglyceride levels in patients with very high fasting~     triglyceride levels ≥ 500 and ≤ 1500 mg/dL.~   "
139449|NCT01229553|"~     The primary objective of this study is to measure efficacy of our new protocol by monitoring~     the results of our routine respiratory cultures at the end of the new standard treatment,~     and during routine visits for 1 year from initiation of therapy for Staphylococcus aureus.~     The secondary objective will include determining the clinical course (pulmonary~     exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who~     underwent the protocol.~   "
139450|NCT01229540|"~     Retinal neovascularization of diabetic retinopathy might be associated with genetic risk~     factors and environmental risk factors.~   "
139451|NCT01229527|"~     The purpose of this randomized double-blind trial is to define the correct dosage of~     Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to~     analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and~     Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and~     side effects.~      90 patients undergoing colonoscopy will be enrolled.~   "
139452|NCT01229514|"~     General anesthetic medications have been shown to cause neuronal cell death in the brains of~     infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and~     appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI~     (fMRI) is a technique developed for mapping brain activation and has been utilized to~     examine how the brains of children with a history of early exposure to ethanol function~     differently from children without such a history. This study will utilize fMRI to look for~     specific changes in brain activation patterns in children with a history of early exposure~     to general anesthesia, as compared to children without such exposure.~   "
139453|NCT01229501|"~     Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to~     be a key process in the development of cardiovascular disease. Endothelial dysfunction~     appears to be caused by both sleep disordered breathing and obesity. As endothelial~     dysfunction is among the first clinical marker that predicts future cardiovascular events,~     understanding molecular mechanisms leading to impairment of endothelial function is very~     important. Endothelial function requires the proper functioning of endothelial nitric oxide~     synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in~     the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate~     optimal nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially~     organize eNOS in close proximity to signaling proteins that are important for eNOS~     activation. In certain diseases however, the balance of caveolin-1 and eNOS can be disrupted~     resulting in impaired nitric oxide synthesis and leading to endothelial dysfunction.~      The investigators therefore seek to characterize levels of caveolin-1, and correlate this~     with the presence or absence of sleep disordered breathing, obesity, and cardiovascular~     disease. The current IRB protocol covers the performance of fat biopsies on subjects who~     have recently completed a sleep study either in the Center for Sleep Medicine or in our~     sleep laboratory and were found to have sleep disordered breathing or no sleep disordered~     breathing, subject with sleep disordered breathing who have been treated successfully with~     continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in~     our lab who are obese or non-obese and subjects who have known cardiovascular disease and~     subjects without known cardiovascular disease.~   "
139454|NCT01229488|"~     The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure~     oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The~     proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen~     concentrations to monitor oxygen concentrations on the surface of the eye. This will have~     obvious applications in eye research and contact lens testing.~   "
139455|NCT01229475|"~     Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure.~     Even in experienced centres, repeat interventions are necessary in up to 70 of patients to~     achieve sinus rhythm at a long-term follow-up.~      While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for~     the ablation of paroxysmal and persistent AF ablation, different additional ablation~     strategies are used to achieve a modification of the substrate that perpetuates the~     arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated~     atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are~     combined according to the presenting arrhythmia during procedure.~      The aim of the study is to determine whether there is a difference in terms of freedom from~     arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient~     with recurrence of persistent atrial fibrillation.~   "
139462|NCT01229384|"~     Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive~     airway pressure is superior to standard mask ventilation in reducing hospital admissions.~      Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of~     different viruses. It is the most common LRTI in children under 24 months old. Multiple~     studies have documented variation in treatment, hospitalization rates, and length of~     hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to~     improve care for this common disorder.~      Research to determine optimal delivery methods of respiratory medications that may augment~     oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation~     have not been done. Currently bronchodilators are delivered through a passive process,~     inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will~     evaluate whether using a newly developed positive pressure nebulization device that uses~     pressure to expand lung cells and, hypothetically, deliver the medication better, improves~     oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in~     infants with moderate to severe bronchiolitis.~      Positive pressure nebulization is a relatively new adaptation of a previously existing~     modality, and is already currently in use here at PCH.~   "
139463|NCT01229371|"~     The purpose of this study is to assess the humoral immune response and safety of the~     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal~     V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and~     elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.~   "
139464|NCT01229358|"~     This prospective, multi-institutional randomized clinical trial of a silver ion eluting~     dressing material compared to standard dry gauze for closed skin incisions after open~     surgical revascularizations for peripheral vascular occlusive disease. Based on the ability~     of the silver to lower the bacterial contamination of these vulnerable surgical skin~     incisions, the investigators hypothesize that immediate application of Acticoat Absorbent®~     as a post-operative dressing will reduce closed incisional wound complications in patients~     undergoing lower extremity revascularizations involving infrainguinal skin incisions~     compared to standard non-silver eluting dressing material.~   "
139465|NCT01229345|"~     The purpose of this study is to assess the effect of eating breakfast in combination with~     exercise on fat usage, appetite and brain performance later in the day.~   "
139466|NCT01229332|"~     A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD~     dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and~     the potential clinical effect of ND0611 will be explored in subjects with PD and motor~     fluctuations.~   "
139467|NCT01229319|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around~     clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure,~     resulting in genetic damage and mutations, resulting in field cancerization. Subclinical~     AKs may progress to clinical AKs, or even de novo invasive SCCs.~      Among the current therapies for the treatment of AK are excisional surgery, cryosurgery,~     electrodessication and curettage, topical chemotherapy and light therapies. With~     cryotherapy, treated lesion clearance rates at 3 months post-treatment after double-freeze~     thaw cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at~     approximately 5 months post-cryosurgery has been reported to be 35-51%.~      Imiquimod is a topical immune response modifier and a 5% formulation has been approved for~     the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week~     for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also~     reduce subclinical lesions in the treatment area, resulting in fewer new AK lesions~     developing over the same period of time when compared to focal treatment. In a comparison of~     cryosurgery versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial~     complete clearance rates of 68 and 85% by clinical assessment, respectively. However, the~     treatment field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported~     that while application of imiquimod or vehicle following cryosurgery resulted in comparable~     target AK clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group~     had fewer total AKs and fewer subclinical AKs.~      Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior~     to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg~     of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2)~     for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims~     to examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to~     cryotherapy alone.~   "
139468|NCT01229306|"~     Catheter ablation with isolation of the pulmonary veins has proven to be an effective~     treatment option in patients with paroxysmal atrial fibrillation. In patients who have a~     relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators~     compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial~     line.~   "
139469|NCT01229293|"~     This study is conducted at Odense University Hospital(OUH) in collaboration with Institute~     of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical~     Institute, University of Southern Denmark~      Aim: To evaluate the effect of implant design on postoperative total leg muscle function~     recovery and gait in hip replacement patients.~      Design: A prospective randomized controlled clinical trial where patients are randomized~     into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement~     surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks~     post-surgery.~   "
139470|NCT01229280|"~     The proposed study was designed as a randomized two-sequence, two period crossover trial to~     assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic~     formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in~     healthy volunteers in postprandial state.~   "
139471|NCT01229267|"~     This is a study to determine whether investigational V212 reduces the incidence of herpes~     zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic~     cell transplants (HCT).~   "
139472|NCT01229254|"~     The primary purpose of this study is to optimize drug exposure in the target population.~   "
139473|NCT01229241|"~     The aim of the study is the assessment of the systemic absorption of local anesthetics~     during continuous epidural infusion for postoperative pain control.~   "
139474|NCT01229228|"~     The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe~     and effective for the treatment of dental pain.~   "
139475|NCT01229215|"~     This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled~     study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections~     administered monthly or every other month in patients with geographic atrophy.~   "
139532|NCT01228474|"~     Experimental study to assess the efficacy of single embryo transfer (SET) with respect to~     double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be~     randomized in two groups~   "
139476|NCT01229202|"~     Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound~     healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the~     treatment of eye diseases associated with neovascularization. The purpose of this randomized~     study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab~     on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF~     and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy~     surgery, where a small drainage canal is created at the front of the eye, is the most common~     glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular~     pressure. Failure of this procedure is most commonly caused by excessive scarring of the~     surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at~     the time of surgery, wound healing may be slowed and surgical failure prevented.~      The results of this study will be helpful in the future development of new more effective~     and safe surgical techniques for treatment of glaucoma.~      Patients who have given informed consent are randomized into two groups. One group receives~     standard of care for trabeculectomy surgery and the other group receives standard of care~     plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection~     of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are~     seen by their study doctor six times in the following year. At these visits measurements are~     taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical~     exam and at months six and twelve photographs of the patients' eye are taken.~   "
139477|NCT01229189|"~     Vitamin D deficiency is wide spread in South Asian population and is contributing to burden~     of disease in this region including Pakistan. The relative importance of vitamin D~     deficiency, mutation in its receptor and maternal and child health has not been established~     in Pakistan and population based studies are required to explore and avert the maternal and~     Neonatal complications and consequences of Vitamin D deficiency~      The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and~     their Infants. It will be a double blind placebo controlled trial, which will be conducted~     in a rural district of Pakistan.~   "
139478|NCT01229176|"~     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the~     Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is~     highly endemic and an efficacious vaccine against this disease is very much needed.~   "
139479|NCT01229163|"~     Background:~      - Treatment outcomes for substance abuse are improved by regular attendance at counseling~     sessions, and attending at counseling sessions can be futher improved by prize-based~     incentives. However, a system of prize-based incentives can be difficult to administer~     without computerization for accurate recordkeeping and rapid calculation of earnings. NIDA~     researchers have developed the eXtensible Platform for Motivational Incentives (XPMI), a~     computer program that for reinforcement of weekly counseling attendance. Users are eligible~     to win prizes through automated draws. The researchers are interested in testing the~     effectiveness and ease of use of the XPMI software so it can ultimately be run by staff in~     community treatment programs.~      Objectives:~        -  To test the XPMI program in a clinic setting, with emphasis on its functionality,~          usability, and acceptability for counselors.~        -  To test and validate XPMI s accuracy in calculating incentives to reinforce drug~          abstinence.~      Eligibility:~      - Individuals at least 18 years of age who are participating in clinical trials for~     treatment of heroin dependence in an outpatient treatment-research program, and have at~     least 14 weeks remaining in the program.~      Design:~        -  Participants will meet with their counselors as regularly scheduled. Twelve of the~          visits will count toward this study, with 2 extra weeks in case of counselor absence or~          clinic closure.~        -  Participants will receive an incentive in the form of a prize draw for arriving to~          counseling appointments on time, on the scheduled day. (Participants may reschedule one~          appointment per week without losing the chance for a prize draw.) For each consecutive~          appointment attended on time, participants will receive extra prize draws; attending~          three counseling appointments in a row can earn four bonus prize draws.~        -  To draw for prizes, participants will push a button on a computer. Each prize draw~          could result in a small prize worth $1 to $2, a large prize worth $20, a jumbo prize~          worth $100, or no prize at all. The average prize total per person is expected to be~          about $378.~        -  Participants will also be asked to fill out questionnaires about the computer program.~   "
139480|NCT01229150|"~     Background:~      AZD6244 (ARRY-142886) is an investigational anticancer drug that is designed to block a~     critical component (MEK (methyl ethyl ketone)) of a pathway (MAP (mitogen-activated protein)~     kinase pathway) that causes some lung cancer cells to grow. The MAP kinase pathway could be~     overactive in a proportion of lung cancers, including some which also have another mutation~     in a protein known as KRAS (Kirsten rat sarcoma viral oncogene homolog). Approximately 20%~     of lung cancers have KRAS mutations which can make some cancer treatments including~     erlotinib, a standard anticancer treatment drug less effective. Researchers are interested~     in determining whether AZD6244 is effective in treating advanced NSCLC (non small cell lung~     cancer), including KRAS mutated lung cancer that has not responded to standard therapy.~      Objectives:~      To determine the effectiveness of AZD6244, either alone or in combination with erlotinib, in~     preventing tumor growth in individuals with NSCLC.~      Eligibility:~      Individuals at least 18 years of age who have been diagnosed with advanced NSCLC that has~     not responded to standard therapy.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood~          tests, imaging studies, and potentially, tumor biopsy tests to determine whether a~          participant's NSCLC contains mutations in the KRAS protein.~        -  Participants will be divided into two groups based on the status of the KRAS protein in~          their NSCLC tumor cells:~        -  Individuals with normal KRAS protein: Half will receive AZD6244 and erlotinib, and half~          will receive only erlotinib.~        -  Individuals with mutated KRAS protein: Half will receive AZD6244 and erlotinib, and~          half will receive only AZD6244.~        -  Participants will take their assigned medications daily (on an empty stomach in the~          morning and/or evening, depending on the treatment) for 28-day cycles of treatment.~          Participants will also keep a medication diary to record any side effects.~        -  Participants will have frequent blood tests during the first cycle of treatment, and~          will have imaging studies or other tests as required by the study researchers.~          Participants may also have an additional tumor biopsy after the end of the first~          treatment cycle.~        -  Treatment will continue until the disease progresses, significant side effects develop,~          the participant chooses to leave the study, or the researchers end the study....~   "
139481|NCT01229137|"~     Assessment of sensor parameter in patients with heart failure.~   "
139482|NCT01229124|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in RNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with~     acute myeloid leukemia.~   "
139483|NCT01229111|"~     This phase II trial is studying how well giving cediranib maleate together with combination~     chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin,~     leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving cediranib~     maleate together with combination chemotherapy may kill more tumor cells.~   "
139484|NCT01229098|"~     The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on~     the hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with~     extensive psoriasis vulgaris.~   "
139485|NCT01229085|"~     To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5%~     in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.~   "
140594|NCT01214525|"~     The improvement in uroflow and postvoid residual urine in children after urethral meatotomy~     for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus~     justifying the procedure.~   "
139486|NCT01229072|"~     The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an~     endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates~     its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting~     cascade, especially the anti-activated factor X. The end result of these actions is the~     inhibition of biochemical training and synthesis of certain clotting factors that activators~     of critical functions in the genesis of a blood clot. Patients with chronic renal failure~     (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct~     thrombin inhibitor and / or heparinóides to prevent thrombosis.~      Based on clinical studies, to control the level of plasma heparin in patients with CRF is~     essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa~     should be used as a substrate of protection for those patients on hemodialysis.~   "
139487|NCT01229059|"~     This study aims to explore time-dependent effects of lipid infusion an intramyocellular~     lipid metabolites and the induction of impaired insulin signaling.~   "
139488|NCT01229046|"~     This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in~     infants <91 days of age with suspected systemic infection.~   "
139489|NCT01229033|"~     Catheter ablation has proven to be an effective treatment option in patients suffering from~     symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major~     steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and~     (2) modification of left atrial and eventually right atrial substrate by ablation of complex~     fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary~     veins, around the left atrial appendage, at the mitral annulus and the septum.~      When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial~     tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the~     significance of the AT is unclear.~      In the following study we examine the hypothesis that an ablation of AT occuring during CFAE~     ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia~     (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group~     2).~   "
139490|NCT01229020|"~     Assessment of regional contribution of different areas of the lung to its integrated~     function is often required, such as prior to lung resection in the presence of tumor or~     emphysema. This assessment is derived from the proportion of zonal radionuclear perfusion or~     ventilation. The investigators hypothesized that lung VRI may provide an alternative~     approach to assess regional lung function.~   "
139491|NCT01229007|"~     The objective of this study is to assess the efficacy and safety of a Von Willebrand~     Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of~     Biostate in children with haemophilia A.~   "
139492|NCT01228994|"~     The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers,~     baclofen will be superior to placebo for smoking abstinence measures.~      The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit~     higher rates of medication compliance (i.e. take the medication as directed for the trial~     period) than those in the placebo group.~      The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco~     withdrawal and craving ratings as compared to placebo.~   "
139493|NCT01228981|"~     The purpose of this study is to characterize type 2 diabetic patients with initial~     alterations of diabetic retinopathy (DR) based on 3 different phenotypes previously~     identified and different patterns of progression in order to correlate this data with~     genetic information.~   "
139494|NCT01228968|"~     Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be~     used to compare two abdominal fat segmentation techniques. The first technique is already~     validated and in use. The second technique was recently developed and has not been~     validated. The hypothesis is that the second technique will be the faster and more reliable~     of the two.~   "
139495|NCT01228955|"~     Impaired health related quality of life (HRQOL) including fatigue, problems with sleep and~     psychosocial well being (physical, emotional, and spiritual) have been noted in adult cancer~     survivors. Physical domain is one of the most common measured indicators of HRQOL. Despite~     the tremendous implications of having an impaired QOL, few studies have staged interventions~     aimed at improving HRQOL in a heterogeneous group of cancer survivors. There is little~     literature examining whether a yoga intervention is feasible in a heterogeneous group of~     cancer survivors.~      The proposed research will utilize Vanderbilt Ingram Cancer Center (VICC), Nashville General~     Hospital (NGH) and REACH for Survivorship program for a pilot study. The investigators will~     see if a study using a broad range of diagnoses is feasible for a Yoga Intervention.~   "
139496|NCT01228942|"~     The purpose of this study is to determine if the COXEN algorithm, using the diagnostic~     device Affymetrix GeneChip, is able to predict which chemotherapies will be best for~     treatment of recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.~   "
139497|NCT01228929|"~     Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and~     after an intervention (such as a dry eye treatment, environmental change, artificial tear~     use, or contact lens wear) in a controlled-environmental chamber, over time using~     non-contact instruments.~   "
139498|NCT01228916|"~     Tobacco use and tobacco-caused illnesses and death are increasing in developing countries~     globally, so it is critical to study these countries in order to effectively address the~     tobacco epidemic. The proposed project will test the effectiveness of community-based~     interventions for secondhand smoke and quitting smoking in eight underserved communities in~     the Dominican Republic. The project will also partner with communities and national and~     international groups to determine whether the methods and interventions from this study in~     the Dominican Republic can also be used to help other countries in the region and~     underserved groups in the United States.~   "
139499|NCT01228903|"~     This study will test the hypothesis that uric acid impairs the function of vessels in~     patients with kidney disease~   "
139566|NCT01228032|"~     There is an urgent need to develop practical, sustainable approaches to improving medical~     care for persons treated in community mental health settings. This study will test a novel~     approach for improving mental health consumers based on a partnership model between a~     Community Mental Health Center and a Community Health Center. When this study is completed,~     it will provide a model for a medical home for persons with severe mental illness that is~     clinically robust, and organizationally and financially sustainable~   "
139500|NCT01228890|"~     In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the~     CATCH-IT primary care/Internet based depression prevention intervention against Attention~     Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an~     intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk~     adolescents based on elevated scores on the PHQ-A, a screening measure of depressive~     symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into~     either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months~     post intake on measures of depressive symptoms, depressive diagnoses, other mental~     disorders, and on measures of role impairment in education, quality of life, attainment of~     educational milestones, and family functioning; and (d) conduct exploratory analyses to~     examine the effectiveness of this intervention program, moderators of protection, and~     potential ethnic and cultural differences in intervention response.~   "
139501|NCT01228877|"~     Performing adduction and abduction resistance exercise will increase hip bone density and~     strength to a greater extent than doing squat and deadlift exercise.~      Aim #1: To determine if doing hip adduction and abduction resistance exercise training for~     16 weeks improves spine bone mineral density and hip bone mineral density and strength as~     determined by finite element modeling.~      Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift~     exercise with respect to potential changes in hip bone mineral density and strength.~      Aim #3: To determine if the addition of adduction and abduction exercise to squat and~     deadlift exercise promotes an additive effect with respect to changes in spine bone~     mineral density and hip bone mineral density and bone strength.~   "
139502|NCT01228864|"~     The Brody belt may help improve quality of life in patients using urinary drainage bags.~     PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in~     patients using urinary drainage bags.~   "
139503|NCT01228851|"~     The purpose of this study is to assess the facilitation of balance in Parkinson's disease~     (PD) patients using the Nintendo Wii fit, with the ultimate goal of developing a program for~     function and fitness in this patient population. In this study, PD patients will participate~     in group exercise classes using the Wii Fit and the effects on balance, postural sway, and~     quality of life assessed.~   "
139504|NCT01228838|"~     The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998~     applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).~   "
139505|NCT01228825|"~     Infection, especially mediastinitis, is major complication in cardiac surgery. Considering~     that cardiopulmonary bypass (CPB) can alter kinetics of drugs, including antibiotics, the~     aim of this study was to evaluate the influence of cardiopulmonary bypass ( CPB) on plasma~     concentrations and pharmacokinetics of cefuroxime, administered prophylactically, in a 1.5g~     dose, followed by three bolus of 750mg every 6 hours, for 24 hours, in 19 patients~     undergoing coronary artery bypass graft (CABG) with CPB (CPB Group, n = 10), or without CPB~     (Off-Pump Group, n = 9); and assess whether the proposed dosing regimen is adequate to~     maintain plasma concentrations above 16 g/L (4 times the MIC) for the first 24 hours after~     the beginning of surgery.~   "
139506|NCT01228812|"~     The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis~     patients with healthy matched controls.~   "
139507|NCT01228799|"~     Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one~     operation is superior to the other. Both procedures are performed in patients with medically~     uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure,~     which showed encouraging results without antimetabolite usage intra- and postoperatively.~     Purpose of the study is to compare both surgeries concerning success rate, intraocular~     pressure, medication and complications. So far there is no comparison of the standard~     procedure trabeculectomy and the new approach, canaloplasty available.~   "
139508|NCT01228786|"~     The present study is designed to examine the expression of VDR, CaSR, PTH, Cyclin D1, Ki67~     and PCNA and to find out its relationship with clinical parameters in parathyroid adenomas.~     Examination of the contribution of genes expression can elucidate the critical link between~     proliferation and functional abnormalities in parathyroid adenomas. Alternative to DNA and~     RNA, protein expression can provide a better understanding of this disease.~   "
139509|NCT01228773|"~     The objective of this study is~        1. to develop a web-based, tailored program for Cancer-related fatigue in cancer~          survivors, which is comprehensive and evidence-based,~        2. to evaluate the efficacy for cancer-related fatigue as a result of participating in the~          Web based, tailored program(Health Navigation®) for 12 weeks~        3. to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction~          with the treatment as a result of participating in the Web based, tailored~          program(health navigation®) for 12 weeks~        4. to assess the efficacy of such intervention compared with usual care in cancer~          survivors~   "
139510|NCT01228760|"~     The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD)~     and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate~     cancer (CRPC).~   "
139511|NCT01228747|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients~     aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment~     with 1 or 2 anti-epileptic drugs.~   "
139512|NCT01228734|"~     The purpose of this study is to assess whether the progression free survival (PFS) time with~     FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for~     mCRC in Chinese subjects with RAS wild-type tumors.~   "
139513|NCT01228721|"~     PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the~     reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma~     patients and healthy control subjects using Spectralis® SD-OCT.~      METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator~     within one session with a brief rest between measurements. Three measurements were taken~     with the eye-tracker and retest function, and three were taken without this function,~     alternating between measurement methods.~        -  Trial with medical device~   "
139567|NCT01228019|"~     This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant~     (TREDAPTIVE) in usual practice in Korea according to the new product re-examination~     regulations of the Korean Food and Drug Administration.~   "
139514|NCT01228708|"~     Aims:~      To design a proactive implementation strategy for a chronic-disease-management-programme.~      To describe effects of the active implementation of a programme for COPD-patients measured~     on patient-related goals and use of health resources.~      To describe stakeholders' evaluation of the implementation.~      Materials and method:~      An intervention study with 3000 COPD-patients cluster-randomized after a bloc-randomization~     of their GP-practice. 18 GP-practices in Ringkøbing-Skjern-Municipality are randomized to~     receive an active implementation or to an as usual group. A neighboring municipality acts~     as sleeping control. With data from registers and a questionnaire-survey the effect on~     COPD-patients self reported-health, evaluation of health system and changes in distribution~     of health resources is analyzed. How health professionals perceive the implementation and~     how it influences their conception, interactions and culture is illustrated by interviews~     with stakeholders.~      We expect to see improved health related quality of life, enhanced evaluation of the health~     system and a more appropriate distribution of health resources in the intervention group.~   "
139515|NCT01228695|"~     Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect~     of long-term systemic steroids therapy.~      This study aimed to investigate the impact of long-term systemic steroid treatment on sleep~     apnea.~   "
139516|NCT01228682|"~     A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns~     of Samsca in routine medical practice.~      A Post-Authorisation Safety Study is performed to collect information on the safety of~     Samsca when used in a real-life setting.~   "
139517|NCT01228669|"~     This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate~     the safety, pharmacokinetics (how the trial drug is distributed in the body) and~     pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021~     administered intravenously and subcutaneously to healthy male subjects and subjects with~     haemophilia A or B~   "
139518|NCT01228656|"~     The aims is to evaluate the efficacy and comparative isolation of the association Mometasone~     furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the~     Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque~     psoriasis grade mild to moderate.~   "
139519|NCT01228643|"~     Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry~     Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in~     controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with~     pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study~     randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay~     Farma Ltda.~   "
139520|NCT01228630|"~     The loratadine-pseudoephedrine combination has proven to be more effective than the use of~     these individual components. This prospective, randomized, double-blind and paralel study,~     in which patients with perennial allergic rhinitis receive one of loratadine +~     pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.~   "
139521|NCT01228617|"~     This is an explorative study comparing new prototypes of Nicotine Replacement Products with~     Nicorette® gum.~   "
139522|NCT01228604|"~     This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR)~     for children with ADHD aimed at assessing whether the observable behavioral changes seen~     during treatment are associated with potentially more stable underlying modifications in~     brain functioning (resting-state functional connectivity). Additionally, we will also be~     looking at treatment effects on neuropsychological processes and reading skills. This~     information will contribute to the first Brazilian study assessing the cost-effectiveness of~     the treatment of ADHD. Children with ADHD will be compared to a sample of sex and~     age-matched sample of typically developing children.~   "
139523|NCT01228591|"~     The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses~     against ACUVUE® ADVANCE® lenses in the plus power parameters.~   "
139524|NCT01228578|"~     The investigators are conducting a double-blind, placebo controlled,randomized trial of~     multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in~     slowing disease progression, indicated by increased CD4 count, weight gain, and improved~     quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e.~     peripheral neuropathy, anemia, and diarrhea).~      The investigators hypothesize that daily multivitamin supplementation will: (1) improve~     immune reconstitution; (2) improve weight gain, and (3) improve quality of life.~   "
139525|NCT01228565|"~     The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+~     (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients~     receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.~   "
139526|NCT01228552|"~     The purpose of this study is to evaluate the efficacy and safety of intra-oral topical~     ketoprofen for the treatment of acute migraine.~   "
139527|NCT01228539|"~     The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and~     Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress~     disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering~     with PTSD and problems with anger after returning from military service in Afghanistan~     (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be~     participants. The goal is to determine if a present-centered psychotherapy that teaches~     skills for emotion regulation and does not require re-telling of traumatic memories is as~     efficacious as the trauma memory-focused PE psychotherapy.~   "
139528|NCT01228526|"~     To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without~     significantly compromised arterial circulation.~   "
139529|NCT01228513|"~     The purpose of this study is to evaluate the efficacy and safety of three concentrations of~     a development drug compared to placebo in the treatment of atopic dermatitis.~   "
139530|NCT01228500|"~     The primary aim of this study proposal is to test an innovative form of fetal bovine dermis~     bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound~     healing in diabetic foot ulcers.~   "
139568|NCT01228006|"~     It is hoped that the group treated with Panax Ginseng, Vitamins and Minerals obtain~     significant reduction in levels of stress and fatigue and that the results are superior to~     the placebo group.~   "
139533|NCT01228461|"~     Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly~     those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications~     such work has for effective interventions, little is known about the underlying~     pathophysiology of fatigue, association with medical co-morbidities and factors that may~     help predict those to be at highest risk.~      The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship~     Program together with the investigators Hematologic Malignancies Program. In adolescent and~     young adults (AYA), ages 18 - 39 the investigators will address the following:~      Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on~     functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for~     fatigue~      Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine~     activity and fatigue Aim 2: Evaluate the association between fatigue and self reported~     fatigue in AYA Hodgkin lymphoma (HL) survivors.~      Hypotheses:~        1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to~          general population and will be associated with impaired functional outcome.~        2. Risk factors for fatigue include higher disease stage, B symptoms and elevated~          erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher~          doses and more expanded fields of radiotherapy.~        3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine~          complications.~        4. Levels of specified proinflammatory cytokines are associated with increased fatigue.~   "
139534|NCT01228448|"~     The investigational part of this study is using a mobile PET/CT scanner to take images of~     the participants tumor immediately after they are treated with proton radiation. This allows~     the participant to be treated and imaged on the same bed. The information obtained may~     improve the accuracy of treatment and may help to minimize the dose delivered unnecessarily~     to healthy tissue.~   "
139535|NCT01228435|"~     IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein~     is called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from~     being destroyed by cells. These proteins can mutate to give off signals that allow cancer~     cells to keep growing. By blocking the function of Hsp90, we hope that the cancer cell will~     block the mutated protein and cause the cancer cells to die. This drug have been used in~     other research studies and in the laboratory and information from those other research~     studies suggests that thsi drug may help to treat lung cancer with ALK mutations. In this~     research study, we are looking to see what effects IPI-504 has in patients with lung cancer~     who have an ALK mutation.~   "
139536|NCT01228422|"~     The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon~     product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon~     alpha-2A - Roche Laboratory).~   "
139537|NCT01228409|"~     Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At~     present, there is no curative therapy available and the clinical course is unpredictable,~     but in the majority of cases psoriasis is a chronically remitting and relapsing disease.~     Several clinical subtypes of psoriasis exist with differences in manifestations and skin~     areas involved.~      Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease,~     accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and~     erythematous and often symmetrically distributed over the body. Several types of palliative~     therapies exist. The therapies are either topical or systemic. The severity of chronic~     plaque psoriasis is often determined by the percentage of body surface area (BSA) involved.~     For mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%,~     initial therapy is topical. Phototherapy and numerous systemic therapies are usually~     indicated when more than 20% of skin is affected.~      Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and~     maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard~     treatment that provides clinically significant efficacy, however many patients experience~     tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events~     include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity,~     elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of~     HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis,~     headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to~     17.5mg/day may provide improved tolerability without compromising efficacy.~      The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to~     17.5mg/day will provide improved tolerability without compromising efficacy.~   "
139538|NCT01228396|"~     Patients with marked bladder dysfunction as a result of secondary progressive multiple~     sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in~     this double-blind crossover study.~   "
139539|NCT01228383|"~     Study design:~      Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184~     + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV~     vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV],~     mono-center study~      Study objectives:~      Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.~      Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to~     evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects.~     To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or~     placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo~     in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the~     monoclonal antibodies (mAbs).~   "
139540|NCT01228370|"~     Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors,~     α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with~     or without neurogenic bladder.~      α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in~     patients with neurogenic bladder.~      Based on these turnouts, we designed this clinical study to evaluate the clinical effect and~     safety of silodosin on voiding dysfunction associated with neurogenic bladder.~   "
139541|NCT01228357|"~     The purpose of this study is to determine whether genetic information associated with~     individual depressive symptoms.~   "
139542|NCT01228344|"~     The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign~     residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to~     their demographics, including evaluation of their malaria immune status, treatment~     effectiveness, prior and concomitant medication use, and the occurrence of adverse events in~     association with artemether-lumefantrine treatment, based on the information collected in~     the CDC Malaria Case Surveillance Report Form.~   "
139579|NCT01227863|"~     The primary objective of this study is to evaluate, through clinical parameters, the~     effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B -~     Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin~     and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the~     end of treatment, among the products studied.~   "
139543|NCT01228331|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving more than once~     drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses~     high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or~     high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin~     hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with~     acute lymphoblastic leukemia.~      PURPOSE: This randomized phase II/III trial is studying the side effects of giving~     clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination~     chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see~     how well it works in treating young patients with T-cell acute lymphoblastic leukemia or~     precursor B-cell acute lymphoblastic leukemia.~   "
139544|NCT01228318|"~     With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely~     to be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts~     the cells responsible for bone resorption form under the influence of the key~     osteoclastogenic cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and~     proresorptive activities of RANKL are moderated by its physiological decoy receptor~     osteoprotegerin (OPG). Imbalance in the ratio of RANKL to OPG alters osteoclastic bone~     resorption and lead to osteoporosis. Activated T- and B-cells are a major source of RANKL,~     while normal physiological B-cells are a major source of OPG. T-cells regulate the~     production of OPG by B-cells. Thus changes in the immune system induced by HIV/AIDS and/or~     by HAART could affect B-cell and T-cells RANKL and OPG production. Indeed, data from our~     group shows that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development~     of osteoporosis is recapitulated as observed in HIV-infected patients, and B-cell OPG and~     RANKL production are concurrently down regulated and upregulated respectively. Furthermore,~     preliminary data in HIV-infected subjects suggests dramatic acute upswing in bone resorption~     following HAART initiation that peaks at 12 weeks and then declines. Based on these~     findings, the investigators hypothesize HAART associated bone loss is driven by immune~     reconstitution. Because this effect of HAART is dramatic in magnitude but short in duration,~     the investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to~     specifically spare patients from this dramatic but acute bone damage.~   "
139545|NCT01228305|"~     The current proposal tests the central hypothesis that acetaminophen will attenuate the~     oxidative stress response associated with cardiopulmonary bypass (CPB)-induced hemolysis in~     children undergoing cardiac surgery.~   "
139546|NCT01228292|"~     The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis~     with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill~     Patients.~   "
139547|NCT01228279|"~     Hypothesis:~      Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic~     activity in response to an increase in leptin and insulin. Converting patients from a~     regimen of only glucose containing dialysate to a regimen with non-glucose-based solution,~     icodextrin, will reduce the insulin and leptin levels and will reverse dialysis-induced~     increases in sympathetic activity.~   "
139548|NCT01228266|"~     The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate~     the safety and tolerability of autologous mesenchymal stem cell transplantation in patients~     with active multiple sclerosis~   "
139549|NCT01228253|"~     This preliminary study will examine the differential effects of rTMS on the recall of~     extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress~     disorder ) compared with subjects without PTSD but with high risk of relapse.~   "
139550|NCT01228240|"~     Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus.~     Different pharmaceutical types of metformin are available. As a clinical trial, we compared~     the efficacy and complications of metformin produced by Pars Mino pharmaceutical company,~     Iran with Apotex pharmaceutical company, Canada, in type 2 diabetic patients.~      Method: 18 eligible women with type 2 diabetes were given metformin Pars Mino or Apotex~     (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study.~     After 2 weeks washout period another 6 weeks period with another Brand of metformin was~     prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were~     assessed before and after each treatment phase. The results were compared with each other by~     paired sample T-test, Independent sample T-test.~   "
139551|NCT01228227|"~     An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after~     otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch~     occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after~     PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing~     obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent~     studies have suggested that pretreatment with Atorvastatin may be associated with a~     reduction in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in~     patients undergoing elective coronary-PCI and already treated with aspirin is clopidogrel~     loading dose administration before procedure.(8,9)The investigators compared a high (80mg)~     re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both~     administered within 24h before the procedure in reducing the rate of periprocedural MI.~     Therefore, the investigators will conduct a single center, prospective randomized study to~     assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with~     a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of~     biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of~     MACCE(occurring of cardiac death, myocardial infarction (including periprocedural~     myonecrosis) and stroke at 30 days 6 and 12 month follow-up.~   "
139625|NCT01227265|"~     This is a study of the efficacy and safety of preladenant in adult participants with~     moderate to severe Parkinson's Disease (PD). While on this study, participants will continue~     to take their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct~     PD medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or~     placebo, twice daily, for 12 weeks. After that, participants may choose to receive~     additional treatment with preladenant. The primary hypothesis is that at least the 5 mg~     twice daily dose of preladenant is superior to placebo as measured by the change from~     Baseline to Week 12 in the mean off time.~   "
139552|NCT01228214|"~     Treatment of coronary artery disease is a major health care problem across the entire word,~     and the United States. Unfortunately, despite a number of medical advances, diagnostic~     procedure, or epidemiological studies, the treatment of these patients remain complex, and~     and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United~     States and Canada documented that drug treatment, coronary interventions or both were not~     effective solution in coronary artery diseases.~      A novel approach has recently been developed, based on the critical role of the potassium~     (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by~     hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs,~     whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions.~      This apparently simple mechanisms occurs in human blood in all individuals but could be~     altered in subjects with acquired or hereditable defect in red-blood-cell K content, as in~     hypertensives or CAD patients.~   "
139553|NCT01228201|"~     The purpose of this study is to examine the effect of two different physical exercise~     protocols on changes in coronary artery plaque composition and development of in-stent~     restenosis in patients treated with percutaneous coronary intervention with stent~     implantation. The investigators will compare aerobic interval training and moderate~     continuous training. Both exercise protocols have a duration of 12 weeks. The investigators~     hypothesize that aerobic interval training is superior to moderate continuous training~     regarding effects on the composition of coronary artery plaques and a reduction in the~     development of in-stent restenosis.~   "
139554|NCT01228188|"~     The purpose of this study is to evaluate the efficacy and safety of surgical treatment of~     FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in~     patients with a macular hole.~   "
139555|NCT01228175|"~     The study will test genetic factors that may predict the effectiveness of varenicline.~   "
139556|NCT01228162|"~     The researchers want to investigate the effects of muscle relaxation with rocuronium bromide~     during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic~     consumption in patients with total hip prosthesis replacement (general vs. spinal~     anaesthesia).~   "
139557|NCT01228149|"~     The most common cause of post-trabeculectomy filtration failure is postoperative scarring.~     Long-term preoperative treatment with local antiglaucoma agents containing preservatives has~     an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons~     prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs,~     controlling IOP with oral acetazolamide, and treating the eye with local steroids.~      Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP~     preoperatively with the aim of avoiding postoperative excessive scarring and the known~     adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term~     outcomes.~      This study will investigate comparability (non-inferiority) of medical benefits of two~     different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing~     COSOPT-S® bid to oral acetazolamide plus dexamethasone.~   "
139558|NCT01228136|"~     The purpose of this study is to determine if the use of tranexamic acid prior~     adenotonsillectomy in children can reduce surgical and postoperative bleeding.~   "
139559|NCT01228123|"~     The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite~     manifold improvements in ICU care. At present, it is not clear if the method chosen for~     renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous~     haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a~     prospective randomised clinical study of the effect of continuous versus intermittent renal~     replacement therapy on the mortality and outcome of acute renal failure will be performed.~   "
139560|NCT01228110|"~     Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents~     the development of sepsis related complications with a significant reduction in duration of~     mechanical ventilation~   "
139561|NCT01228097|"~     This study will compare brain and hormone responses to food images (and food) in women who~     undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic~     adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss~     surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your~     present weight). The investigators will use magnetic resonance imaging (MRI) to see how the~     brain responds to pictures of food and to consuming a liquid meal replacement. The~     investigators wish to determine whether the two surgeries have different effects on~     appetite, as observable in the brain, and whether the possible effects on appetite differ~     from those in participants who have a similar body weight but remain relatively weight~     stable. The investigators also will draw blood to determine how hunger and fullness~     hormones change after eating and to see if there are any differences among the three groups.~     The study is being sponsored by the National Institutes of Health (NIH).~   "
139562|NCT01228084|"~     This phase II trial studies how well sulforaphane works in treating patients with recurrent~     prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.~   "
139563|NCT01228071|"~     This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal~     testosterone range after initial testosterone gel 2% application, time to steady state after~     after initiation of testosterone gel 2%, and drying time after application of testosterone~     gel 2%.~   "
139564|NCT01228058|"~     The purpose of this study is to evaluate the clinical utility of thrombelastography (TEG) to~     predict and identify trauma patients at increased risk of receiving blood transfusion,~     develop multiple organ failure and mortality.~      TEG has been proposed as a superior tool to rapidly diagnose and help guide resuscitation~     with blood products and preclinical data suggest that TEG is both more sensitive and~     specific than PT or PTT for coagulation abnormalities. Based on the preclinical work led by~     Dr. Holcomb, our hypothesis is that the Rapid TEG will help to identify these coagulopathic~     patients earlier, allow for rapid MT protocol activation, and assist in developing data~     driven blood product transfusion guidelines.~   "
139565|NCT01228045|"~     The investigators hypothesis is that the combination of TS-ONE with cisplatin and~     trastuzumab is safe and as effective as combination treatment for HER2 positive gastric~     cancer.~   "
139626|NCT01227252|"~     This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of~     LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.~   "
139569|NCT01227993|"~     Background:~        -  Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under~          the retina and can cause distorted vision. CSC often resolves on its own without~          treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss.~          Chronic CSC may be partly caused by hormones called androgens.~        -  Finasteride is a drug that can modulate the effects of androgens; currently it is~          marketed as a treatment for male pattern baldness and benign prostate enlargement. The~          results of a previous brief study suggest that finasteride is safe and may help reduce~          the effects of chronic CSC. However, more long-term data are needed to evaluate whether~          finasteride is a safe and effective treatment for chronic CSC.~      Objectives:~      - To collect more data on the safety and effectiveness of finasteride as a treatment for~     chronic central serous chorioretinopathy.~      Eligibility:~      - Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot~     Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous~     Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment.~      Design:~        -  The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits~          occurring every 6 months. Participants will be screened with a medical history,~          physical examination, eye examination, and blood and urine tests.~        -  At each visit, participants will receive a supply of finasteride pills to take every~          day and will need to bring any leftover finasteride pills to the following visit.~        -  Participants will have eye examinations to test vision, eye pressure, eye movements,~          and retinal thickness. Additional eye examinations will evaluate the retina's~          sensitivity to light and study the blood vessels and flow of blood in the eyes.~        -  Blood and urine samples will be taken throughout the study.~        -  After the end of the study, participants may be able to speak to their doctor about~          continuing finasteride treatments with a prescription.~   "
139570|NCT01227980|"~     Background:~      - Individuals who are dependent on alcohol often have feelings of anxiety, irritability,~     anger, and depression. These feelings, as well as stress, may contribute to the risk of~     relapse and continued drinking. Studies have shown that alcohol consumption increases the~     activity of certain molecules in the brain known as CRH1 receptors, which are key to~     producing the body s response to stress, and whose activation generates feelings of anxiety.~     Researchers are interested in learning whether the experimental drug pexacerfont, which~     blocks CRH1 receptors and has been studied in individuals with anxiety disorders and~     depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence~     treatment.~      Objectives:~      - To determine the safety and effectiveness of pexacerfont as a treatment for~     anxiety-related alcohol craving.~      Eligibility:~      - Individuals between 21 and 65 years of age who are alcohol-dependent and have problems~     with anxiety.~      Design:~        -  This study requires an inpatient admission to the NIH Clinical Center for approximately~          1 month, with two additional study visits 1 week and 1 month after discharge from the~          hospital.~        -  Participants will be screened with a medical history, physical examination, and blood~          and urine tests.~        -  During the inpatient period, participants will have standard treatment for alcohol~          dependence, including support and interventions from institute staff to address~          cravings, anxiety, or other psychological problems. Participants will not receive~          formal psychological treatment or psychiatric medications for anxiety, but will receive~          training in relaxation techniques.~        -  Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During~          this time, participants will have the following procedures:~        -  Frequent blood tests.~        -  Rating scales and questionnaires about alcohol cravings and anxiety.~        -  Dexamethasone suppression test with frequent blood draws to study hormone response to~          stress.~        -  Social stress test involving public speaking, followed by blood samples and~          questionnaires on alcohol craving.~        -  Cue Reactivity (CR) session to study cravings and responses to alcohol-based cues.~        -  Functional magnetic resonance imaging scan to evaluate brain activity while taking the~          medication or placebo.~        -  Participants will have two follow-up visits for additional blood tests and~          questionnaires about the effects of the treatment ^.~   "
139571|NCT01227967|"~     Seasonal influenza is responsible for many hospitalizations and deaths each year, despite~     effective antiviral treatments. Some individuals have medical conditions such as heart or~     lung diseases that make them particularly at risk of severe influenza infections that may~     result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu,~     but there are still many hospitalizations, complications, and deaths even with treatment.~     This study will evaluate the use of combination antivirals (amantadine, oseltamivir, and~     ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk~     population.~   "
139572|NCT01227954|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.~      PURPOSE: This phase II trial is studying how well avoiding the hippocampus during~     whole-brain radiation therapy works in treating patients with brain metastases.~   "
139573|NCT01227941|"~     This study will determine whether MK-4827 can be safely administered in combination with~     pegylated liposomal doxorubicin, and if so, will obtain an estimate of the benefit of the~     combination in patients with ovarian cancer as compared to historical data with single agent~     pegylated liposomal doxorubicin. The first part of the study (Part A) is designed to~     determine the maximum tolerated dose (MTD) and evaluate the safety of MK-4827, when~     administered in combination with pegylated liposomal doxorubicin. Part B is designed to~     assess preliminary clinical activity of MK-4827, when administered in combination with~     pegylated liposomal doxorubicin to participants with ovarian cancer. It is hypothesized that~     MK-4827 can be administered, in conjunction with pegylated liposomal doxorubicin, with~     acceptable tolerability and that MK-4827, administered in conjunction with pegylated~     liposomal doxorubicin, will demonstrate a tumor response rate equal or superior to that of~     historical data for pegylated liposomal doxorubicin alone.~   "
139574|NCT01227928|"~     This is a study to determine whether therapy with pazopanib is effective and safe in Asian~     women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has~     not progressed on first-line chemotherapy.~   "
139575|NCT01227915|"~     The primary objective of this study is to evaluate, through clinical parameters, the~     comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% -~     Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using~     the percentage of improvement (sustained response rate) at the end of treatment.~   "
139576|NCT01227902|"~     The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and~     health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the~     following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine,~     lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures~     (POS) using a flexible dosing regimen.~   "
139577|NCT01227889|"~     BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and~     tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced~     (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg~     of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until~     disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC~     will be allowed to crossover to an optional extension arm of the study to receive~     GSK2118436.~   "
139578|NCT01227876|"~     Is the primary objective of this investigation to compare the clinical efficacy of the drug~     test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator -~     Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of~     postoperative inflammation in cataract surgery by phacoemulsification through periodic~     measurement of efficiency scores (number of cells in the anterior chamber, the presence of~     fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).~   "
139725|NCT01225952|"~     The objective of this study is to compare the contrast sensitivity, high and low contrast~     visual acuity (VA), glare meter outcomes, and subject satisfaction with three different~     FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near~     vision following lens extraction in adults at least 40 years of age.~   "
139580|NCT01227850|"~     Background and study hypothesis:~      Refeeding syndrome is a dangerous condition which could arise if patients who have had~     little or no food for many days, are started on any form of feeding. The metabolic~     consequences of this condition could affect the heart, lungs and nervous system of the~     patient and cause serious imbalance in the level of salts in the body.~      The available guidelines for predicting that refeeding syndrome may occur are very~     subjective since they depend mainly on a history which is sometimes difficult to obtain from~     the patient.~      The main biochemical landmark that refeeding syndrome has occurred is a fall in the~     phosphate levels once feeding has been started. There are currently no biochemical markers~     that can identify patients at risk of developing refeeding syndrome.~      Leptin and IGF1 are hormones which have been observed to go down if someone has had little~     or no food for a while. The investigators therefore hypothesized that using a combination of~     leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical~     marker to predict that refeeding may occur, hence take the precautionary measures to avoid~     its occurrence before starting feeding.~      Design: Thirty five consecutive patients referred for commencement of parenteral nutrition~     (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes,~     liver and renal function tests were measured before and daily for one week after initiating~     PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN.~     A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of~     1.0 in patients who are well nourished.~   "
139581|NCT01227837|"~     In this double blinded study patients with resynchronization pacemaker- AICD were assigned~     to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than~     placebo in mortality, BNP level and 6 minutes walk test.~   "
139582|NCT01227824|"~     The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50~     mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be~     tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual~     NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve~     adult subjects.~   "
139583|NCT01227811|"~     The present study was designed to assess the bioequivalence and pharmacokinetic profiling of~     a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in~     healthy volunteers after a high fat breakfast.~      The bioequivalence will be evaluated using:~        -  the Area Under the Curve (AUC) and,~        -  the peak plasma concentration (Cmax).~      Safety will be evaluated recording:~        -  vital signs~        -  adverse events,~        -  laboratory analysis.~        -  EKG and chest XRays.~      Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:~        -  mean AUCt/AUCr and 90% confidence interval within 0.80-1.25~        -  mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.~   "
139584|NCT01227798|"~     A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the~     treatment of patients hospitalized with Influenza-like illness caused by a novel swine~     origin Influenza virus and other circulating Influenza Viruses.~      The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral~     is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.~   "
139585|NCT01227785|"~     This study has 2 purposes:~      The first purpose of the study is to test a new family of Boston Scientific Implantable~     Cardioverter Defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds)~     and show how well these new devices work in patients. This new family is called the INCEPTA~     ICD and the INCEPTA CRT-D.~      The second purpose of the study is to collect data from a feature that monitors breathing.~     It is called the Respiratory Rate Trend (RRT). These data will help to better understand how~     changes in breathing relate to changes in clinical conditions.~   "
139586|NCT01227772|"~     Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve~     survival of patients with advanced Gastric Cancer.~   "
139587|NCT01227759|"~     This IIa study with intraindividual comparison of treated versus untreated to assess the~     wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an~     abrasive wound healing model.~   "
139588|NCT01227746|"~     Imatinib is the current standard treatment for advanced GIST. Previous studies have shown~     that GIST genotype was associated with treatment outcomes with exon 11 having superior~     outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response~     rate was higher at when imatinib was given at 800mg daily compared with the standard dose of~     400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response~     in metastatic GISTs is intriguing, more information is needed before mutation testing is~     adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing~     GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate,~     overall survival does not appear to be better with high-dose therapy. The investigators~     propose to conduct a retrospective analysis of mutational analysis on patients with GIST and~     determine the relationship between patient response and imatinib dose.~   "
139589|NCT01227733|"~     Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks~     for gene expression analysis. This has clinical relevance as gene expression signatures may~     then be profiled using archival tumor blocks, which are more readily available than frozen~     tissues.~   "
139590|NCT01227720|"~     Comparative pharmacokinetic study of new oral nicotine replacement therapy products.~   "
139591|NCT01227707|"~     This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus~     Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic~     region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer.~     Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2~     weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation~     therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the~     discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months~     will be given.~   "
139627|NCT01227239|"~     The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin~     combined with radiation by Phase I/II study.~      The purpose of this study is as follows,~        -  In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated~          dose (MTD).~        -  In phase II, to evaluate the antitumor effect (pCR rate) and the safety .~   "
139628|NCT01227226|"~     The effect of artificial tears on tear osmolarity~   "
139592|NCT01227694|"~     This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15~     patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the~     study with the primary objective of assessing the feasibility and safety of the knee~     articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary~     objectives are to assess the efficacy by imaging procedures and clinical questionnaires.~      MSC obtained from each patient's bone marrow will be isolated and expanded Ex-Vivo under~     GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21~     days, patients will be implanted a single-dose of approximately 40 millions of autologous~     MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage~     changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical~     assessment will measure the pain by the visual analogue scale (VAS), the self-reported~     functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short~     Form 36 questionnaire (SF-36) at 3, 6 and 12 month.~      The working hypothesis proposes that the expected regenerative articular cartilage effect of~     the MSC will be produced to a measurable degree by imaging procedures and clinical~     questionnaires.~   "
139593|NCT01227681|"~     The purpose of this study is to evaluate the effectiveness of neuroprotection from~     granulocyte colony-stimulating factor on Parkinson disease~   "
139594|NCT01227668|"~     The purpose of this study is to determine whether pediatric participants with irritability~     associated with autistic disorder who have responded to aripiprazole treatment will~     experience a relapse significantly later when continuing therapy with aripiprazole than will~     participants who receive placebo~   "
139595|NCT01227655|"~     Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an~     estimated incidence of 4.5-16/100,000 persons/year.~      BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition~     to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients.~     Promising results have been obtained for BIA 9-1067 in previous studies.~   "
139596|NCT01227642|"~     In standard treatment, the seeds are placed throughout the prostate to treat the entire~     prostate. This is done because it was impossible to know where the cancer was located within~     the prostate. A new technique has been developed using the same ultrasound imaging that you~     probably had when you had your biopsy. Using this technique, areas likely to contain~     prostate cancer can be identified.In this early study of 15 subjects, we will test if this~     method to plan your prostate seed implant is safe and can be done as part of regular care.~     Areas identified as suspicious for cancer will be treated with higher doses of radiation~     while those areas not demonstrating cancer will be treated to the standard minimum dose. The~     higher dose areas will receive two times the minimum dose the prostate usually receives.~     Because this technique is not perfect, those areas not identified as cancerous should be~     treated in case there is a cancer area that the technique did not identify. Subjects~     enrolled in this study will then be followed with this ultrasound technique over the next~     two years to monitor the changes to the cancerous areas and will undergo a biopsy two years~     after the procedure. Subjects will, of course, be monitored to assess the success of the~     technique and its side effects.~   "
139597|NCT01227629|"~     The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone~     or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding~     and other adverse events.~      A secondary objective of this trial is to evaluate the anticoagulant effect of different~     doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory~     marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate~     bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.~   "
139598|NCT01227616|"~     The objectives of this study are to compare the efficacy and safety of repeat doses of~     intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with~     hemodialysis-dependent CKD.~   "
139599|NCT01227603|"~     Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence~     of a new fixed dose combination tablet of nifedipine GITS and candesartan with the~     corresponding loose combination and to compare it with the individual drugs~   "
139600|NCT01227590|"~     The study is being conducted to evaluate whether African potato, an herbal medicine, can be~     used together with anti-HIV medicines without affecting the amounts of the anti-HIV~     medicines in the blood. African potato is an African herbal medicine widely used in Africa,~     particularly sub-Saharan Africa. Although it has not been proven, it is believed to help~     boost the immune system. Similar studies have been done on herbal medicines especially those~     that are used in developing countries. In some cases, the herbal treatments can affect the~     blood levels of other medicines when the medicines are used together. This study will~     measure the effect of African potato on lopinavir/ritonavir (Kaletra®), a common anti-HIV~     medicine. Lopinavir/ritonavir is approved by the United States Food and Drug Administration~     (FDA). The information obtained from this study will tell us if African potato and anti-HIV~     treatments can be used together to treat HIV infected patients in Africa and other resource~     poor regions.~   "
139601|NCT01227577|"~     This is a single-arm, open-label, multi-center study of complete molecular response (CMR)~     in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic~     myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and~     deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate~     of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients.~   "
139602|NCT01227564|"~     This study in individuals with early Alzheimer's disease is designed to assess:(1) safety~     and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load~     as measured by positron emission tomography (PET) scans.~   "
139642|NCT01227044|"~     This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX)~     and counseling on highly active antiretroviral treatment (HAART) medication adherence in a~     cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol~     abuse and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a~     behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC~     incorporates the behavioral platform Medical Management (MM) from the National Institute on~     Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with~     Medication Coaching (MC), a manualized treatment designed to improve HAART medication~     adherence in HIV-infected patients with substance use disorders.~   "
139603|NCT01227551|"~     Approximately 63 patients with stage IIIc or stage IV melanoma will receive 10 intratumoural~     injections of CAVATAK (Coxsackievirus A21) over 18 weeks.~      Disease progression will be monitored by computed tomography (CT) and rated by the RECIST~     1.1 assessment criteria. Patients will be monitored for 1 year from their first treatment.~      CAVATAK is an oncolytic (cancer killing) virus. Direct injection of the virus into tumors~     may kill cancer cells by the lytic action of the virus. This action also releases tumor cell~     debris that may illicit a response by the patients own immune system against the tumour.~     This study seeks to assess the performance of CAVATAK in both of these actions in late stage~     melanoma.~      Study objectives include:~        -  Immune-related Progression-Free Survival~        -  Durable Response Rate~        -  Progression Free Survival at 6 months~        -  Quality of Life~   "
139604|NCT01227538|"~     Type 1 diabetes is condition in which progressive autoimmune destruction of~     insulin-producing beta-cells leads to absolute insulin deficiency. At the time of clinical~     presentation, it is estimated that 50-80% of beta-cell function has been lost. Good~     glycaemic control from diagnosis has been shown to preserve beta-cell function. The recent~     identification of immuno-interventions able to reduce autoimmune destruction and preserve~     beta-cell function has lead to an increased urgency to develop such tools.~      With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no~     tests that are suited for use in clinical practice to detect and monitor residual beta cell~     function. There is a therefore a need for a test that is sufficiently sensitive to assess~     beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be~     simple, reproducible and suitable for use even in the non-observed setting.~      Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion~     that reliably reflects insulin production) response as a reference, we propose to compare~     mixed meal stimulated urinary C-peptide as potential candidate for this application. This is~     a pilot investigation in which a sample of 30 participants will be recruited.~      It is anticipated that the current project will identify a simple method for analysing beta~     cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations~     of recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects~     who may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and~     novel immuno-intervention strategies designed to preserve residual beta cell function and~     improve long-term outcomes. Currently such immunointervention has been reserved for subjects~     within 3 months of diagnosis only, excluding a significant number of subjects who may~     potentially benefit.~   "
139605|NCT01227525|"~     Behavioral and physiologic observations suggest that the injection of local anesthetic is~     among the most feared or anxiety producing procedures during dental intervention. Discomfort~     during the injection is currently reduced by pharmacologic or mechanical methods. No~     technique has proven to be effective for every patient. The VibraJect LLC (USA) was first~     introduced in 1995 and was developed under the hypothesis that a vibrating needle would~     stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying~     the pain signal from the injection site. Studies on adult patients have been promising. The~     purpose of this study is to investigate the efficacy of the VibraJect dental syringe~     attachment in reducing injection discomfort and procedural anxiety in the pediatric dental~     population.~   "
139606|NCT01227512|"~     The purpose of this study is to determine if hospitalized patients with symptomatic~     hyponatremia treated with tolvaptan are in the hospital for less time than patients treated~     with fluid restriction. The study will also test if tolvaptan is better than fluid~     restriction in treating the symptoms of hyponatremia in hospitalized patients.~   "
139607|NCT01227499|"~     Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their~     clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold~     standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine~     uptake is limited for its availability in china and easily influenced by medicine or food~     contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of~     thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily~     varied by operator subjective judgement. This study is focus on the role of peak systolic~     velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods:~     Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two~     clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic~     velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level~     below the low value of normal range. Graves disease is defined as the typical symptoms of~     graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is~     defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use~     receiver operator curve(ROC) to evaluate its diagnosis value~   "
139608|NCT01227486|"~     The purpose of this study is to determine whether verification of correct tube placement~     after endotracheal intubation in the obese patient can be conducted as fast with ultrasound~     as with the conventional method of combined auscultation and capnography.~      The investigators hypothesize that ultrasound is a faster method for verifying correct~     endotracheal tube placement in the obese patient than combined auscultation and capnography.~   "
139609|NCT01227473|"~     Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic~     criteria for diabetes, is an increasingly common condition, particularly among African~     Americans. Changes in physical activity, changes in diet, and levels of stress influence the~     course of the disease. Helping individuals to reduce stress and to increase healthy coping~     strategies may enhance conventional diabetes prevention efforts, especially among African~     Americans. Mindfulness training is a cost-effective intervention which may be effective in~     reducing stress and enhancing the ability to make behavioral changes. This exploratory pilot~     study will examine the potential efficacy of a diabetes prevention education program that~     includes training in mindfulness-based stress reduction (intervention group) for~     pre-diabetic African Americans, comparing it to a conventional diabetes prevention program~     (control group) in the ability to improve glucose metabolism as well as other relevant~     physiological and psychological secondary outcomes.~   "
139671|NCT01226654|"~     The primary purpose of this study is to detect changes in the brain that may be associated~     with multiple sclerosis. Results will be compared to age matched controls. Investigators~     will assess lesions by measuring T2 and T1 enhanced lesion volumes and magnetization~     transfer ratio histogram parameters (MTRHP) in patients with relapsing-remitting and~     secondary-progressive disease. This data will be correlated to total brain parenchymal~     volume as well as identifying the effect of MS lesions on the gray and white matter,~     volumetric disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a~     specific battery of neuropsychological tests. Quantitative analysis of whole brain~     N-acetylaspartate (WBNAA), a reproducible measure of viable neuron number, using 1H MRS and~     compare the results to age-matched controls over duration of 5 years.~   "
139726|NCT01225939|"~     A study conducted over 3 periods to look at the drug in the body.~   "
139610|NCT01227460|"~     This is a multi-center, prospective, randomized, double-blind, parallel, placebo controlled~     clinical trial evaluating the efficacy of sitagliptin in suppressing glucagon release in~     subjects with type 1 diabetes over a 16 week treatment period. The hypothesis of this study~     is that sitagliptin (Januvia™) will decrease post-prandial glucagon release and may result~     in improved glucose control in adult patients with type 1 diabetes. There is only one small,~     pilot study of sitagliptin in patients with type 1 diabetes which significantly reduced~     total daily insulin dose and A1c values while improving mean blood glucose (MBG) and time~     spent in euglycemic range (1). In the pilot study, GLP-1 and glucagon levels were not~     assessed. The purpose of this trial is to determine if sitagliptin can suppress the~     paradoxical rise of glucagon, and thus can decrease A1c.~      This study will enroll a maximum of 140 patients (with an expected 10% dropout rate) with~     A1c values between 7.5-10% who will be randomized in a 1:1 fashion to either the study drug~     or placebo. 100 of these patients will wear a continuous glucose monitor. Subjects may be~     using insulin via continuous subcutaneous insulin infusion (CSII) or multiple daily~     injections (MDI). The clinic visits will be conducted at screening, -1 week,~     baseline/randomization, 4 weeks, 12 weeks, and 16 weeks in addition to telephone visits~     (Appendix 1 and 2). At home, starting at week 0 (randomization/baseline), subjects will take~     100 mg/day of sitagliptin or placebo and continue for the study duration. Laboratory~     analysis will be performed at various time points assessing glucagon, A1c, C-peptide,~     glucagon-like-peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and insulin~     levels.~   "
139611|NCT01227447|"~     The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the~     urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further~     characterise morphology and function of the suburothelial myofibroblast network in the human~     bladder outlet.~   "
139612|NCT01227434|"~     This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as~     measured by progression free survival at 6 months) in patients with recurrent glioblastoma~     multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15~     will undergo a planned surgical resection and receive drug for 7 days prior to surgery,~     followed by drug after recovery from surgery, and the other 15 patients will receive drug~     without a planned surgical procedure.~   "
139613|NCT01227421|"~     This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing~     regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated~     influenza in adults and adolescents. The investigators hypothesize that treatment with~     Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza~     infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will~     reduce the complications of influenza, severity of symptoms, time lost from work, time to~     return to normal daily activities.~   "
139614|NCT01227408|"~     The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing~     chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and~     capecitabine. It is expected this combination will at least maintain the efficacy of a~     traditional chemotherapy regimen but will be associated with less toxicity, particularly~     nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a~     chemotherapy regimen whose components (or administration schedule) are associated with~     minimal or no alopecia and are also considered to have low emetogenic potential.~      In an attempt to improve the efficacy of the regimen the investigators plan to study an~     alternate schedule of cyclophosphamide and methotrexate administration (metronomic~     chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of~     conventional cytotoxic chemotherapy administered concurrently.~      In this trial the investigators aim to determine the clinical and pathologic response rate~     of 12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic~     chemotherapy with cyclophosphamide and methotrexate will be administered during the 24 weeks~     of chemotherapy.~   "
139615|NCT01227395|"~     The investigation will be conducted for the purpose of determining the condition of~     occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet,~     verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug~     interactions and determining the factors affecting safety and efficacy.~   "
139616|NCT01227382|"~     The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis~     when compared to standard biopsy techniques.~   "
139617|NCT01227369|"~     Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate~     treatment~   "
139618|NCT01227356|"~     Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between~     imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly.~      Primary endpoint: To compare at 12 months between the treatment arms the rate of Major~     Molecular Response (=99,9% tumour reduction) at 12 months~   "
139619|NCT01227343|"~     The aim of this study is to assess the impact of smoking on cortical GABA levels in males~     and females. Using magnetic resonance spectroscopy (MRS), we will examine the impact of sex~     and menstrual cycle phase on brain neurochemistry in healthy smokers and non-smokers. We~     hypothesize that female, but not male, smokers will have reduced cortical GABA levels~     compared to their non-smoking, sex-matched counterparts.~   "
139620|NCT01227330|"~     The purpose of this study is to pilot test a behavioral medication adherence (MA)~     intervention compared to control condition in older adults with low adherence to medication~     for hypercholesterolemia.~   "
139621|NCT01227317|"~     The purpose of this study is to evaluate the capacity of some novels biomarkers~     Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial~     natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to~     stratify the risk in severe dyspnea.~   "
139622|NCT01227304|"~     -  test for volume responsiveness~        -  PiCCO-guided infusion over a pre-defined period of time~   "
139623|NCT01227291|"~     The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with~     elevated IOP.~   "
139624|NCT01227278|"~     To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD) in Adults.~   "
139672|NCT01226641|"~     The aim of this study is to determine the usefulness of a telemedicine system for the~     follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the~     telemedicine system will enhance compliance and thus reduce self-measured blood pressure.~   "
139629|NCT01227213|"~     Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has~     improved the outcome of patients with several types of cancer remarkably. However, their~     application is hampered by side effects, such as development of hypertension with~     consequences for renal and cardiac function. Moreover patients treated with angiogenesis~     inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to~     change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients~     with various cancer diagnoses and therefore the clinical relevance of both short term and~     long lasting adverse events will translate into reduced quality of life. In addition,~     premature withdrawal of angiogenesis inhibitors due to side effects may result in lower~     response, shorter duration of response and possibly a shorter survival. Therefore, adequate~     treatment of above mentioned side effects in patients treated with angiogenesis inhibitors~     is of relevance for the response rate, the duration of progression free survival and overall~     survival and for quality of life.~      Mechanistic insight in the pathogenesis of these side effects will help optimizing~     treatment.~      Objective: The primary objective of the study is to investigate the effect of sunitinib on~     endothelial function, insulin sensitivity, renal function and renal blood flow.~      Study design: Single-centre non randomized observational study Study population: 30 Patients~     (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.~   "
139630|NCT01227200|"~     The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL~     in addition to the local anesthesia injection, can help reducing the pain intensity in~     patients who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision~     and drainage .~   "
139631|NCT01227187|"~     The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an~     anticoagulant at different dose levels during dialysis treatment in patients with End Stage~     Renal Disease (ESRD).~   "
139632|NCT01227174|"~     The purpose of this study is to determine if the use of propofol only to achieve procedural~     sedation for the removal of third molars is both safe and effective.~   "
139633|NCT01227161|"~     Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in~     all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size~     will results in soft tissue injury to trachea by means of the pressure, insufficient~     ventilation, and aspiration, therefore choosing the adequate ETT size has very important~     clinical aspect.~   "
139634|NCT01227148|"~     To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical~     outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.~   "
139635|NCT01227135|"~     RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Biological therapies, such as hydroxychloroquine, may~     stimulate the immune system in different ways and stop cancer cells from growing. It is not~     yet known whether imatinib mesylate is more effective when given with or without~     hydroxychloroquine in treating patients with chronic myeloid leukemia.~      PURPOSE: This randomized phase II trial is studying the side effects of giving imatinib~     mesylate with or without hydroxychloroquine and to see how well it works in treating~     patients with chronic myeloid leukemia.~   "
139636|NCT01227122|"~     Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase~     Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients~     with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of~     NGAL.~   "
139637|NCT01227109|"~     Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and~     treatment is of paramount importance as infections may be life-threatening in~     immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as~     a marker of infection. However, the CRP is also often elevated in cancer patients and as a~     marker CRP may be unreliable in cancer patients. Other markers for infection includes~     procalcitonin which has been showed to be of some value for the diagnose of bacterial~     infections.~      This study examines procalcitonin as a potential marker of bacterial infection in cancer~     patients.~   "
139638|NCT01227096|"~     The purpose of this study is to determine whether electroacupuncture preconditioning would~     provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation~     in children undergoing CPB for repair of congenital heart defects.~   "
139639|NCT01227083|"~     Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and~     cAQOL) in Korean patients with persistent asthma~   "
139640|NCT01227070|"~     This study is a longitudinal single-center pilot study designed to describe changes in lung~     function and levels of noninvasive biomarkers of airway inflammation in children ages 6-18~     years over two months following hospitalization for an acute exacerbation of asthma. Forty~     children ages 6-18 years with asthma who are admitted to Children's Hospital and Regional~     Medical Center (GCRC) for an asthma exacerbation will be enrolled and complete an initial~     study visit prior to hospital discharge. Children with asthma will be recruited from the~     inpatient medical unit. During their initial visit subjects will undergo a clinical~     assessment and perform spirometry to measure lung function. In addition, exhaled nitric~     oxide (eNO) concentration will be measured and a sample of exhaled breath condensate (eBC)~     will be collected during 20 minutes of tidal breathing. Breath condensate will be analyzed~     to determine the concentration of cysteinyl leukotrienes (CysLT), an important mediator of~     airway inflammation in asthma. Subjects with asthma will return to the GCRC pediatric~     satellite at Seattle Children's Hospital for follow-up study visits at 1 week, 2 weeks, and~     4 weeks following hospital discharge. During follow-up visits subjects will complete a~     questionnaire regarding symptoms and medication use since the most recent study visit, will~     perform spirometry, and have eNO concentration measured and breath condensate collected for~     CysLT analysis.~      The aims of this observational study are to:~        1. Assess the association of levels of exhaled nitric oxide and cysteinyl leukotrienes in~          breath condensate with measures of airflow obstruction (FEV1) and asthma symptoms~          during, and at one, two, and four weeks following hospital discharge for asthma~          exacerbation.~        2. Compare levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate~          from children ages 6-18 years hospitalized for status asthmaticus to levels from~          age-matched healthy control subjects without asthma.~   "
139641|NCT01227057|"~     The purpose of this investigation is to examine treatment outcome of a new intervention for~     hoarding in older adults compared to standard case management for hoarding. The new~     intervention combines exposure therapy and cognitive remediation.~   "
139673|NCT01226628|"~     The main purpose of this study to evaluate the safety and tolerability of CNTO 2476~     administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in~     patients with visual acuity (acuteness or clearness of vision) impairment associated with~     the geographic atrophy (GA: partial or complete wasting away of retinal layer below the~     retina) manifestation of age-related macular degeneration (AMD: medical condition which~     usually affects older adults and results in a loss of vision in the center of the visual~     field [the macula] because of damage to the retina).~   "
139643|NCT01227031|"~     Androgenic alopecia, the common form of hair loss is a highly heritable disorder of~     considerable social significance affecting around 40% of adult men and women. A variety of~     genetic and environmental factors are likely to play a role in androgenetic alopecia.~     Genetic variants in the human androgen receptor gene (AR) have been reported to be~     associated with AGA in Caucasians. Other genes involved with hair loss also have been found.~     One of them being a gene on chromosome 3 (3q26). A recent genome-wide association study in~     296 individuals with male-pattern baldness and 347 controls had carried out and five SNPs on~     chromosome 20p11 were found to be highly significant association for AGA (rs2180439 combined~     P = 2.7 x 10(-15)). No interaction was detected with the X-chromosomal androgen receptor~     locus, suggesting that the 20p11 locus has a role in a yet-to-be-identified~     androgen-independent pathway.~      The total number of evaluated patients with androgenic alopecia will be at least 300. All~     patients will be further grouped as good responders or poor responders to conventional~     medications, such as topical minoxidil and systemic finasteride. Candidate genes potentially~     involved in gout and its treatment response will be selected from the published literatures;~     specifically, two resources of candidate genes will be selected: (i) genes which are known~     to directly link with androgenic alopecia, and (ii) genes are potentially implicated in~     particular pathways of androgen/estrogen receptors, metabolism and downstream signals, and~     genes involved in anti-oxidants or hair growth. The SNP genotyping will be performed by~     MALDI-TOF Mass Spectrometry. Data analysis will be performed by comparing SNPs allele~     frequency between good responder and poor responder to conventional medications of patients~     with androgenic alopecia and further comparing to the allele frequency of SNPs in healthy~     controls. A functional study will also be done to prove the genetic association.~   "
139644|NCT01227018|"~     RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells~     by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is~     studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the~     treatment of patients with metastatic pancreatic cancer.~   "
139645|NCT01227005|"~     The proposal will assess if patients who require massive transfusion can be accurately~     predicted early after emergency department arrival and assess if the use of stored whole~     blood during initial resuscitation will reduce transfusion needs compared to transfusion~     with component therapy and thus improve outcome.~   "
139646|NCT01226992|"~     Recurrent CDI is a growing problem with few treatment options that provide lasting effect.~     Fecal transplantation has been shown in several case series to be successful in controlling~     recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing~     fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory~     CDI. Approximately 146 patients will be enrolled over one year. Participants in the study~     will be followed for 120 days, and will be given the opportunity to cross over to the~     alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure~     will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention.~     Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120~     days (same strain of C. difficile), attributable mortality, hospitalization and serious~     adverse events.~   "
139647|NCT01226979|"~     This research is being done to see how effective high-dose rate endorectal brachytherapy~     (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we~     want to try to decrease side effects and shorten the course of radiation treatment for~     patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy~     (HDRBT). This is a different form of radiation than what is normally given. With HDRBT, the~     radiation is given through an applicator placed into the bowel next to the tumor. The~     radiation is directed at the tumor and a small area around it.~   "
139648|NCT01226966|"~     This observational study is conducted in Europe. The aim of this non-interventional~     (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess~     the conditions of use of Victoza® in daily medical practice in France.~   "
139649|NCT01226953|"~     This study will evaluate the safety and immunogenicity of booster dose of two commercially~     available vaccines used to prevent Haemophilus influenzae type b infections in children~     365-569 days of age~   "
139650|NCT01226927|"~     The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve~     blocks has not been established. To our knowledge, this is the first study to compare the~     efficacy of an automated intermittent bolus technique to a continuous rate of infusion of~     local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus~     technique would provide enhanced analgesia compared to a continuous infusion rate as~     assessed by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and~     visual analog scale (VAS) pain scores.~   "
139651|NCT01226914|"~     Primary Objectives~        -  To compare the amount of post-operative wound drainage between the group of patients in~          which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™~          placebo is utilized (Arm B).~        -  To compare the length of time to drain removal between Arm A and Arm B. Secondary~          objectives~        -  To compare the incident or rates of seroma, hematoma, and post-operative edema between~          the two groups.~        -  To compare the reported pain experienced in each group at selected time points using a~          standard numerical rating scale (NRS).~        -  To compare the length of hospital stay between the two groups of patients.~   "
139652|NCT01226901|"~     This study will evaluate whether oral administration of MK-4827 to participants with~     advanced solid tumors is generally safe and well tolerated.~   "
139653|NCT01226888|"~     Androgen deprivation therapy (ADT) is considered standard of care for prostate cancer.~     However, changes in the patients metabolism are usually seen as a result of hormone therapy.~     These changes include increased fat mass, decreased lean mass, weight gain, high blood~     cholesterol, increased incidence of diabetes, and possibly increased incidence of cardiac~     events such as heart attack. The researchers of this trial would like to learn if these~     change in body mass are affected by the presence of brown fat in the body. Brown fat is made~     up of fat cells that are stored in the body and generate heat to control body temperature.~     Levels of brown fat are at the highest in newborn babies and decrease over time into~     adulthood. The researchers of this trial would like to learn more about these changes in~     metabolism during prostate cancer treatment by studying the changes in brown fat during the~     first 12 months of hormone therapy.~   "
139654|NCT01226875|"~     Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL~     energy is focused on in order to break kidney stones and this energy can be varied in size~     from a narrow (or small) focal zone to a wide (or large) focal zone. This is a~     multi-centered, randomized study comparing the single treatment success rates of narrow and~     wide focal zones during SWL.~   "
139655|NCT01226862|"~     This study will promote the development and economic sustainability of telemedicine for~     acute stroke treatment.~   "
139656|NCT01226849|"~     Incorporation of rituximab to conventional chemotherapy (R-CHOP) has revolutionalized the~     frontline treatment of diffuse large B-cell lymphoma (DLBCL), one of the commonest subtype~     of lymphoma. Although the majority of patients are cured, there still remains a substantial~     number patients (20-30%) who will relapse despite upfront R-CHOP therapy. Recent studies~     have informed that in the rituximab era, the ability to salvage patients with relapsed DLBCL~     with the conventional salvage regimens like R-ICE or R-DHAP is significantly poorer than~     expected. For a patients who has been exposed to rituximab in the frontline, the response~     rate of conventional salvage chemotherapy is now a mere 51% (Coral Study). This suggests~     that relapses after rituximab exposure are more severe, strongly implying the presence of~     rituximab-resistant disease in additional to the selection of more aggressive subtypes of~     DLBCL which R-CHOP may not have a significant impact on. As R-CHOP is currently the~     frontline standard of care, more has to be done to augment the current available salvage~     regimens as a response rate of 51% is unacceptable.~      Incorporation of agents targeting rituximab-resistance and also the more aggressive subtype~     of DLBCL ( ABC subtype) is prudent in the salvage regimen. Bortezomib, a targeted novel~     agent has potent anti-tumor effects on its own. It has also been show clinically to be able~     to overcome the adverse risk conferred by the ABC subtype of DLBCL. In addition, preclinical~     studies have also demonstrated that bortezomib may enhance the biologic activity of~     rituximab through upregulation of CD20, the target of rituximab.~      The investigators hypothesize that adding bortezomib to salvage regimen of DLBCL will be~     more efficacious. Increasing the response rate will then allow more eligible patients to go~     on to autologous stem cell transplantation. The investigators intend to test the~     tolerability and efficacy of the combination of bortezomib with the R-ICE regimen, and~     attempt to correlate responses with histopathological and gene expression studies of tumor~     specimens.~   "
139657|NCT01226836|"~     The purpose of this study is to assess the feasibility and acceptability of the revised~     Living Well With COPD programme (LWWCOPD for Pulmonary Rehabilitation) when used to deliver~     the education component of pulmonary rehabilitation.~   "
139658|NCT01226823|"~     The study is a multicenter randomized double blind placebo controlled trial. The study will~     be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy~     (ICP) in third level hospitals (that are also Academic Hospitals).~      Pregnant women at the time of ICP diagnosis will be randomized in two groups:~      Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will~     receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.~      The hypotheses are that UDCA treatment will be superior to placebo and effective in:~      reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.~   "
139659|NCT01226810|"~     Purpose of this study is to compare the image quality and diagnostic accuracy obtained with~     ultrafast solid state short SPECT in comparison with the routine SPECT protocol.~   "
139660|NCT01226797|"~     This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C~     virus infection and abnormal liver enzymes.~   "
139661|NCT01226784|"~     Effects of physical training and relaxation exercise on pathophysiological mechanisms and~     symptoms in finbromyalgia patients.~   "
139662|NCT01226771|"~     This is a randomized, open-label, parallel group, multicenter pilot study evaluating the~     efficacy and safety of alternative dosing of ribavirin vs. standard of care dosing in~     combination with peginterferon alpha-2a in interferon naïve patients with chronic hepatitis~     c genotype 1 infection.~   "
139663|NCT01226758|"~     The purpose of this research is to study the safety, tolerability and effectiveness of the~     investigational influenza vaccine in healthy volunteers infected with an attenuated~     influenza A virus.~   "
139664|NCT01226745|"~     The objective of this active-drug Extension Study is to evaluate the continuing safety and~     efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis~     (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 [NCT01081782]).~   "
139665|NCT01226732|"~     The investigators propose this Phase I trial of the combination of AUY922 and capecitabine~     to determine the maximum tolerated dose (MTD) in patients with advanced solid tumors. This~     combination treatment has potential applicability in tumor types where capecitabine or~     fluorouracil is a treatment option, including colorectal and breast cancer.~   "
139666|NCT01226719|"~     In this Phase II study the investigators plan to determine the overall response rate (ORR)~     of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with~     liver-only metastatic KRAS wild-type colorectal cancer.~   "
139667|NCT01226706|"~     Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that~     causes people to feel an urgent need to urinate. Standard treatment for UUI includes~     behavior modification, pelvic floor exercises, anticholinergic medication, and less~     commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately~     effective.~      Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond~     to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in~     neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has~     been used in other studies to improve the symptoms in urinary incontinence, migraines,~     spinal cord injuries and a variety of lower urinary tract disorders. However, the treatment~     of non-neurogenic urinary urge incontinence has not been examined in a well-controlled~     study.~      The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in~     the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives~     are to examine the side effects associated with BTA treatment and the impact this treatment~     has on patients' quality of life.~   "
139668|NCT01226693|"~     There is no difference in the rate and extent of absorption of the material sparing tablet~     (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3~     formulation without SLS.~   "
139669|NCT01226680|"~     This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib~     (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and~     objective clinical endpoints will be measured for a duration of 12-week treatment.~   "
139670|NCT01226667|"~     A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week~     baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for~     one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID~     (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4~     weeks.It is proposed that use of flexible dosing combined with nightly dosing would have~     similar pain relief to fixed dosing, would improve adherence, would have less side effects~     and would be more likely to improve sleep.~   "
139674|NCT01226615|"~     The main purposes of this study are:~        -  to determine the effects of chondroitin sulphate on brain response to pain assessed~          through fMRI in patients with knee osteoarthritis.~        -  to investigate the relationship between treatment response detected by fMRI and the~          results of the different parameters of clinical assessment.~   "
139676|NCT01226589|"~     Adverse drug events can occur commonly due to medication errors during the transition of~     care in a health care facility. Medication reconciliation is the process of comparing~     medications and providing an accurate medication list as a resource for prescribers, which~     is currently only being done upon inpatient admission at the CCI. The purpose of this study~     is to see if pharmacist medication reconciliation at discharge reduces unintentional~     medication discrepancies for inpatient discharges.~   "
139677|NCT01226576|"~     The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has~     the potential to be a safe and effective non-invasive treatment for low to intermediate~     risk, organ-confined prostate cancer involving low incidence of morbidity. The study~     hypothesis will be tested by measuring treatment-related safety and initial effectiveness~     parameters in the ExAblate MRgFUS treated patients, as described above.~      Based on the result of this study, InSightec will initiate a larger study in an effort to~     approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS~     device.~   "
139678|NCT01226563|"~     The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for~     the prevention of ventricular remodeling and congestive heart failure when administered to~     subjects who had successful percutaneous coronary intervention with stent placement after ST~     segment elevation MI (STEMI).~   "
139679|NCT01226550|"~     This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of~     optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy~     (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in~     escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal~     carcinosis (PC).~   "
139680|NCT01226537|"~     Diabetes mellitus (DM) and its vascular complications are the one of the most prevalent~     diseases in the state of Qatar. It is a multifactorial disease associated with the~     development of retinopathy, nephropathy, neuropathy, cardiomyopathy, and severe vascular~     dysfunction. The complications of diabetes are caused by either insulin deficiency (type 1~     DM) or insulin resistance (type II DM).Unfortunately, effective and sustainable prevention~     programs of diabetes are limited, and treatment options for type II DM are restricted.~     Current therapy is based upon control of blood glucose, cholesterol and triglycerides,~     primarily through insulin replacement in type I diabetes or oral hypoglycemic agents and/or~     insulin replacement in type II diabetes. New therapies able to prevent vascular~     complications of diabetes are needed to decrease the occurrence of end organ damage and~     improve the quality of life of the people. Safe and effective nutritional supplements that~     could be given along with the regular treatment of the patients that might reduce the need~     for insulin replacement therapy provide tighter glucose control and protect against~     oxidative stress and the vascular pathology associated with diabetes mellitus are the need~     of the hour. Our hypothesis is that supplementation of Taurine in the diets of diabetic~     patients might reduce the dose or need for insulin replacement therapy and protect them~     against oxidative stress that is responsible for the complications of diabetes mellitus.~   "
139681|NCT01226524|"~     Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet~     count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach~     resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are~     aimed to achieve symptomatic relief, do not change the natural course of the disorder and~     are associated with potential side effects and increase cost. Thus, identifying a new~     therapy that would decrease the bleeding symptoms, without causing significant adverse~     effects, could be very beneficial. Preliminary reports demonstrate a beneficial role for~     Traditional Chinese medicine (TCM) in the treatment of ITP.~      Working hypothesis and aims: The use of TCM will improve the status of children with chronic~     ITP and thus will reduce the need to use conventional medications. The investigators aim to~     study whether in children with chronic ITP, supplementation with TCM, improves the bleeding~     symptoms and ITP-related quality of life (QOL) compared to the period prior to the~     intervention? Methods: The study includes three periods: 1st observation period (1 month),~     TMC period (3 months) and 2nd observation period (2 months). During all study periods the~     following data will be collected: bleeding symptoms, bleeding score, platelet count, need~     for conventional therapy, side effects of therapy and ITP-related QOL.~   "
139682|NCT01226511|"~     The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a~     day by mouth for 10 weeks to children and adolescents, is better than placebo when treating~     Generalized Anxiety Disorder (GAD).~   "
139683|NCT01226498|"~     The objective of this study is to assess effects of the storage of PRBC on endothelial~     function, inflammation and platelet activation in healthy volunteers~   "
139684|NCT01226485|"~     The purpose of this study is to find a recommended dose level and schedule of dosing~     RXDX-109 (formerly LY2940680) that can safely be taken by patients with advanced cancer. The~     study will also explore the changes in a cancer marker level in skin, hair follicles, buccal~     cells, and tumor cells. Finally, the study will help document any antitumor activity this~     drug may have.~   "
139685|NCT01226472|"~     This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous~     T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have~     relapsed after achieving a complete response in study, KW-0761-001.~   "
139686|NCT01226459|"~     This is a six month clinical trial to evaluate the effectiveness and safety in women with~     Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation~     applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.~   "
139687|NCT01226446|"~     Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The~     investigators hypothesize that the correction of hypovitaminosis D before the initiation of~     anti-HCV combination therapy and the maintenance of an optimal vitamin D status during~     antiviral therapy could improve the antiviral efficacy~   "
139688|NCT01226433|"~     This observational study will assess a model for providing family planning through quarterly~     events organized by dairy cooperatives supported by Land O'Lakes in Kenya.~   "
139727|NCT01225926|"~     The purpose of this study was to evaluate and compare uncorrected distance visual acuity~     measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric~     Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.~   "
139689|NCT01226420|"~     Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been~     used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like~     chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests~     that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can~     develop after allogeneic stem cell transplantation. It occurs when the donor immune cells~     (the graft) attack and damage organs and tissue (the host). It is thought that T cells,~     a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this~     research study we are looking to see how well Alefacept works in treating chronic GVHD that~     has not resolved after therapy with corticosteroids.~   "
139690|NCT01226407|"~     Open label, single dose and phase I study.~      The primary objective: To determine the maximum tolerated dose in Single dose~      The secondary objective: to evaluate the toxicity in administration to determine desirable~     dosing amount for phase II to evaluate tumor response in progressive solid cancer patients~     to evaluate pharmacokinetic/ pharmacodynamic profile.~   "
139691|NCT01226394|"~     Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal~     Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent~     and will be pre-registered. All patients will receive the current standard adjuvant~     treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be~     modified if the standard is modified). Then a work-up is done to exclude recurrence. The~     likelihood of a recurrence is low but if this occurs, the patient will not be randomised and~     will be treated with the best known treatment. If the work-up is negative, patients will be~     randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC~     (experimental group).~   "
139692|NCT01226381|"~     This is a Crossover study, double-blind, randomized, controlled versus placebo.~   "
139693|NCT01226368|"~     Cervical cancer is a public health problem. In term of frequency and mortality, it~     represents in Martinique the third localization the most frequently diagnosed and the fifth~     cause of death by cancer. Cervical cancer is recognized as viro-inducted. Human~     papillomavirus (HPV) is the etiologic agent, as a necessary but not sufficient cause, in the~     cancer genesis. It is estimated than about 70 to 80% of women have been or will be infected~     with an HPV in their genital life, the risks factors being those of the others sexually~     transmitted diseases (STD). Most of HPV infection are transient, by spontaneous clearance in~     a few months of the virus under episomal form.~      Carcinogen risk is related to viral persistency which inducts the condition of cellular~     transformation.~      Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of~     the host immunitary response.~      HIV infection is known to be associated with an higher prevalency of one or several~     infection with HPV-HR.~      However, no data about HIV/HPV coinfection prevalency are available nowadays in French~     overseas department of South America whereas they are the most affected by HIV.~   "
139694|NCT01226355|"~     A single blind, multi-center, randomized study is preformed to compare NOYA CoCr~     biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from~     MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr~     biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.~   "
139695|NCT01226342|"~     Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for~     rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.~      The investigators have conceived this study to test whether TCEMS is feasible and tolerated~     by patients experiencing severe physical and psychical challenge of acutely exacerbated~     COPD.~   "
139696|NCT01226329|"~     The Right Question Project-Mental Health (RQP-MH) is a three-session health education~     intervention that teaches clients to participate effectively in mental health care. The~     methodology teaches clients to identify important issues of their illness or treatment,~     formulate questions, and devise plans to communicate and act in effective ways that address~     factors impacting their mental health care, with the expectation that this behavior will~     increase patient-provider communication and improve the therapeutic alliance between patient~     and provider.~      The investigators hypothesize that participants receiving the intervention will be more~     likely to engage and remain in mental health care, and that they will report higher~     activation and self-management scores as compared to control patients.~   "
139697|NCT01226316|"~     This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in~     patients with advanced cancer - and to identify a dose and schedule that can be used in the~     future. This study will also investigate how the body handles AZD5363 (ie, how quickly the~     body absorbs and removes the drug). This study will also investigate anti-tumour activity of~     AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid~     cancers bearing either AKT1 / PIK3CA or PTEN mutation.~   "
139698|NCT01226303|"~     This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL)~     who are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e.~     NPM-RAR-alpha, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).~   "
139699|NCT01226290|"~     The primary objective of this study is to establish the effectiveness and confirm the safety~     of the VizAblate System in ablating symptomatic uterine fibroids.~   "
139700|NCT01226277|"~     This is an open-label, multicenter, Phase I dose-escalation study designed to assess the~     safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory~     solid tumors or lymphoma.~   "
139701|NCT01226264|"~     Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is~     essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an~     emerging MRI imaging technique which has a potential value for the detection of primary and~     recurrent disease and for the assessment of response to therapy. The purpose of this project~     is to evaluate the predictive value of DWI during and after therapy in the prediction of~     recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide~     early information about the response to therapy. This could enable the identification of~     less- or non-responsive tumors and in this way therapy can be adapted as soon as possible.~     Hence the investigators could offer the patient a more efficient treatment scheme and a~     reduction in toxicity related to the treatment could be established.~   "
139702|NCT01226251|"~     This study will assess the ability of a first prototype (strip) of a new chair side test to~     detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines~     in saliva. Previous studies already showed significant correlations between oral malodor and~     the levels of amines in saliva. The limitation in their use as markers of oral malodour is~     the fact that the detection is usually carried out by complex techniques (High Performance~     Liquid Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass~     Spectrometry (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by~     means of a colorimetric scale without necessity of extra apparatus.~      The study will be carried out with volunteers recruited at a multidisciplinary consultation~     for bad breath, organized at the University Hospital Leuven, Belgium.~      The paper strip will be used before the routine evaluation (organoleptic score (OS), the~     gold standard method for the diagnosis of halitosis and the level of volatile sulphur~     compounds (VSC), the most used adjunct tool to diagnose halitosis).~      The results of the new chair side test (strip) will be correlated with the OS and VSC~     measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and~     negative predicted values of the new chair side test will be calculated. The cut-off values~     for a yes/no test will be determined. The meaning of color scores will be analyzed to assign~     a meaningful outcome to each score with relation to odor intensity.~   "
139703|NCT01226238|"~     Patients with major depression who are on a waiting list for psychotherapy usually suffer~     from considerable symptoms. Online self-help is one potential way to alleviate this~     suffering. The investigators want to study if patients awaiting psychotherapy benefit from~     online-self help. The investigators therefore randomly assign patients to either online~     self-help or no intervention and assess their depressive symptoms on a regular basis. The~     investigators hypothesize that online self-help will be superior to no intervention in~     alleviating depressive symptoms in depressed patients awaiting psychotherapy.~   "
139704|NCT01226225|"~     Cardiac rehabilitation, including physical training, has become accepted treatment following~     myocardial infarction, coronary stent implantation and coronary bypass operation. Besides~     modifying patients' risk profile for future coronary problems, the focus is on improving~     exercise capacity. The ability to be able to perform at a higher maximal level is a strong~     predictor for outcome (new cardiovascular events and mortality). The main purpose of this~     study is to evaluate whether aerobic interval training outweighs more classical moderate~     endurance training in improving exercise capacity. During interval training, patients~     perform exercise at high intensity, but for only a couple of minutes and then recover at a~     lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies~     suggests that this type of training leads to a larger increase in exercise capacity,~     compared to the more traditional endurance training at moderate intensity.~      In addition, mechanisms that might explain how this improvement is achieved, as well as~     safety and impact on quality of life will be studied.~   "
139705|NCT01226212|"~     The objectives of this study are to use a nutritional change in the diet to improve gut~     health in older people. Ageing can result in major changes in the composition and activities~     of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections,~     decreased intestinal motility and impaired bowel function as people get older. This can~     result in constipation or diarrhoea, increased levels of inflammation and reduced immune~     response to infection. Therefore, individuals aged 65 or over could benefit from safe and~     effective interventions that maintain a healthy balance of gut bacteria as well as restoring~     the immune response. Bacteria in the gut are known to promote health. Eating foods~     containing beneficial bacteria for example (probiotics) or food which contain substrates for~     the bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The~     investigators will use a synbiotic with known anti-inflammatory properties, comprising a~     probiotic Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been~     previously shown to be beneficial in reducing inflammation and to increase levels of~     beneficial bacteria in the gut in two studies in patients with inflammatory bowel disease.~     The investigators would now for these reasons, like to determine the effects of our~     Synbiotic on the gut bacteria and immune function of older individuals in a double-blinded,~     crossover, placebo controlled, randomised investigation involving 40 volunteers for three~     months. The trial is designed so that participants will be assigned to receive the Synbiotic~     preparation or the placebo for the first four weeks, this will be followed by four weeks~     without treatment, and then they will switch to the opposite preparation for another four~     weeks.~   "
139706|NCT01226199|"~     Smoking is the most important risk factor of COPD, but only a fourth of smokers had COPD in~     their life. There are also healthy smokers without evidence of COPD. Investigators~     hypothesize that innate immunity may affect this difference between COPD patients and~     healthy smokers, because TLR4 is the receptor of LPS, which is the one of important~     substance in cigarette. Investigators will measure TLR2 and TLR4 expression in lung tissue~     of patients whose lung will be resected. Investigators will compare the level of expression~     between COPD patients and healthy smokers.~   "
139707|NCT01226186|"~     The study aims to compare two post operative pain management strategy's, traditional nurse~     dispensed pain control versus patient self medication. The investigators aim to establish if~     patients who self medicate have differing pain levels than those who take nurse dispensed~     oral morphine.~   "
139708|NCT01226173|"~     The purpose of the study is to screen blood donors for the presence of NS1 antigen of the~     dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida)~     using the Platelia Dengue NS1 Ag enzyme immunoassay.~   "
139709|NCT01226160|"~     This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative~     face-down positioning on the outcome of macular hole surgery.~   "
139710|NCT01226147|"~     An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene~     to patients of Lupus Nephritis~   "
139723|NCT01225978|"~     The clinical use of genetic testing is expanding and, as a result, the number of variants~     identified in patients is growing. Knowledge of the clinical impact of these variants~     improves over time. However, the combination of more testing and the rapid evolution of~     genetic knowledge make it impossible for clinicians to fully account for the latest~     implications of their patients' genetic profiles as patient care decisions are made. This~     proposed study plans to enhance and evaluate IT infrastructure developed to provide timely~     genetic variant updates and patient search functionality to clinicians to assist in~     optimizing patient care.~   "
139711|NCT01226134|"~     Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor~     abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal,~     hypersensitivity of the afferent nerves of the gut, psychological disturbances and central~     nervous system dysfunction have been proposed.~      Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory.~     Only small benefits relative to placebo have been found with histamine H2 receptor~     antagonists, proton pump inhibitor and Helicobacter pylori eradication.~      Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent~     is currently indicated for patients with various upper GI symptoms.~      This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic~     acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking~     test)and symptoms in FD patients~   "
139712|NCT01226121|"~     The purpose of this study is to determine if of manipulation of digits following collagenase~     injection for treatment of Dupuytren's contracture is effected by the amount of time between~     injection and manipulation.~   "
139713|NCT01226108|"~     OBJECTIVES:~      Primary Objective The primary objective will be a decrease of inconvenience with at least~     10% for at least 50% of the subjects.~      Secondary Objectives~      The secondary objective will be to:~      To evaluate if the patch can improve the tinnitus patient's quality of life and sleep~     quality.~      METHODOLOGY~      Study Design:~      An open safety and performance clinical investigation of the antinitus patch in patients~     with manifested tinnitus.~      Treatment Duration:~      1 patch per day for 3 weeks~      Primary Endpoint:~      Tinnitus severity questionnaire (TSQ)~      Performance Parameters:~      Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus~     annoyance.~      Quality of life and sleep quality~      Safety Parameters: Adverse Reactions~   "
139714|NCT01226095|"~     This is a prospective, multi-center, post-marketing observational study to evaluate the~     effectiveness and compliance of ibuprofen in a sustained release form in the treatment of~     Egyptian osteoarthritic patients.~   "
139715|NCT01226082|"~     tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct~     currents applied via scalp electrodes to modulate the level of cortical excitability.Several~     studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to~     decrease pain sensation and to increase pain threshold in healthy subjects and in chronic~     pain patients. The aim of this study was to test whether daily sessions of anodal tDCS~     repeated for 5 consecutive days may be effective in reducing pain in a large number of~     chronic pain patients. The cathode is usually applied over the right forhead above the eye.~     The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive~     days will influence on ophthalmologic parametrs.~   "
139716|NCT01226069|"~     The aim of the interventional study is to compare the different treatment modalities in~     reducing erythema size and rate of resolving phlebitis.~   "
139717|NCT01226056|"~     Sorafenib is an oral multikinase inhibitor and among its targets are several RTKs involved~     in tumor genesis (Raf, Flt-3, c-Kit and RET) and angiogenesis (VEGFR1, 2 and 3 and PDGFRß).~     Therefore sorafenib inhibits tumor growth by a dual mechanism, acting either directly on the~     tumor (through inhibition of Raf and Kit signaling) and/or on tumor angiogenesis (through~     inhibition of VEGFR and PDGFR signaling.~      RAD001 is a novel derivative of rapamycin. It selectively inhibits mTOR directly blocking~     tumor cells by preventing tumor cell growth and proliferation and indirectly by inhibiting~     angiogenesis (via potent inhibition of the HIF-1 and consequently VEGF production).~      Targeting mTOR in combination with sorafenib might lead to more profound effects on tumor~     cell biology than could be achieved through individual targeting of some proteins.~      New drugs have often met only limited success since not always target pathways responsible~     for tumor development and growth are targeted. To overcome this problem, the specific~     pathways targeted by the investigators two drugs will be analyzed in each single patient~     before the inclusion.~   "
139718|NCT01226043|"~     Primary Objective:~      To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the~     end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)~      Secondary Objectives:~      To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following~     parameters:~      Randomization/Crossover phase:~        -  Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus~          vial and syringe~      Re-randomization phase:~        -  Change in Fasting Plasma Glucose (FPG) from week 4 to week 10~        -  Percentage of patients achieving FPG<110 mg/dL at week 10~        -  Change in Lantus dose injected per day (U) from week 4 to week 10~      Observational phase:~        -  Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40~        -  Time to first observation of HbA1c<7% during the observational phase~        -  Percentage of patients who discontinue Investigational Product (IP) during the~          observational phase due to dissatisfaction with their current device~      All phases:~        -  Percentage of patients who discontinue IP during each phase of the study~        -  Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events~          (AE)~   "
139719|NCT01226030|"~     This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With~     Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES~     will be selected to perform the pharmacokinetic study profiles.~   "
139720|NCT01226017|"~     The purpose of this pilot study is to investigate the possible change of Oxytocin level in~     human blood after positive interaction with farm animals.~   "
139721|NCT01226004|"~     To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy~     (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA)~     launched the first registry for prostate cancer patients treated with SBRT. The registry is~     designed to track surrogate treatment endpoints including prostate specific antigen (PSA),~     international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue~     scale (VAS) scores, in addition to physical and survival data. Utilizing an independent~     vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic~     registries, FRRA developed a data collection tool that staff members with a basic medical~     background can use to register and upload pertinent patient data, requiring no more than 20~     to 30 minutes per patient. Participating patients will be monitored in follow-up for three~     years, with analysis and publication of the results semi-annually.~   "
139728|NCT01225913|"~     The purpose of this study is to evaluate the site and mechanisms responsible for expiratory~     airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to~     severe persistent expiratory airflow obstruction. Treatment will include inhaled~     corticosteroids and long acting beta2agonists. The investigators are interested in~     determining whether the large and/or small airways are the predominant site of airflow~     limitation. The investigators are also interested in determining whether intrinsic small~     airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow~     limitation. The investigators are also interested to evaluate the role of varying doses of~     inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric~     oxide as surrogate markers of inflammation. For comparison purposes, spirometry and~     measurements of exhaled nitric oxide will also be obtained if possible during a naturally~     occurring exacerbation of asthma.~   "
139729|NCT01225887|"~     This phase II trial studies the side effects and how well nintedanib works in treating~     patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to~     the tumor.~   "
139730|NCT01225874|"~     RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment. Drugs used~     in chemotherapy work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving more than one drug (combination~     chemotherapy) may kill more cancer cells.~      PURPOSE: This trial is studying biomarkers to classify young patients with acute~     lymphoblastic leukemia (ALL) and remission induction therapy in young patients with~     B-precursor ALL.~   "
139731|NCT01225861|"~     The primary objective of the study is the descriptive analysis of incidence & severity of~     side effects & reasons for discontinuation of the treatment of chronic pain with transdermal~     analgesic Buprenorphine patches.~   "
139732|NCT01225848|"~     This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post~     Chemotherapy for Patients With Advanced Urothelial Carcinoma.~   "
139733|NCT01225835|"~     This study is aimed to demonstrate that highly purified Menotrophin produces significant~     lower progesterone serum levels during the follicular phase in comparison to Follitropin~     alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and~     to investigate if the progesterone serum levels might be a useful predictor for the success~     rate of the ongoing pregnancy rates~   "
139734|NCT01225822|"~     The primary objective of this study is to establish the dose-response relationship with~     regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg~     b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients~     undergoing primary elective total hip and knee replacement.~   "
139735|NCT01225809|"~     Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term~     follow-up period to get more information regarding the safety profile of AFFITOPE AD01.~   "
139736|NCT01225796|"~     The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium~     bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1~     (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate~     levels (20 - 28 mmol/L).~   "
139737|NCT01225783|"~     Lymphedema is a common, chronic, side effect resulting from the treatment of breast~     cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted~     conservative treatment is based on the anatomy and physiology of the lymphatic system. The~     aim of the treatment is to reduce the volume of the upper limb by, initial, intensive~     treatment and then to keep the arm volume at this reduced level.The measurement of limb~     volume involves measuring the circumference of the arm at defined points and then with the~     use of a formula the volume of the arm can be calculated. After intensive therapy is~     complete the responsibility for measuring limb volume moves to the patient. This study will~     examine the reliability and validity of self measurement of limb volume. The investigators~     will compare the results of self measurement using the accepted plastic tapemeasure against~     a paper tape measure adapted for self measurement.Both methods will be compared to the gold~     standard volume displacement. In the study there will be two meetings with the subjects~     where the patient and physiotherapist will use the three methods.~   "
139738|NCT01225770|"~     Experimental and clinical studies in adults have reported that green tea catechins prevent~     influenza infection. In this clinical randomized study, the investigators aimed to determine~     the effects of gargling with green tea on the prophylaxis of influenza infection among high~     school teenagers.~   "
139739|NCT01225757|"~     Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is performed in~     patients with peritoneal tumors. Classically, this procedure is prolonged in duration and~     involves significant fluid shifts. Patients receive a large amount of volume replacement~     during this procedure (between 10 and 20 liters). The traditional methods to monitor~     adequacy of volume replacement are measurement of urine output and central venous pressure.~     There are drawbacks of any method of intravascular volume status measurement which may lead~     to over or under replacement of fluids. If fluid replacement is underestimated, the patient~     may suffer from adverse effects such as hypotension and renal dysfunction. However, the~     excessive administration of fluids may lead to other adverse events, including cardiac~     dysrhythmias and heart failure. The hypothesis of this study is that patients in whom volume~     status is maintained by utilizing a transesophageal echocardiogram will have better~     maintenance of fluid status while avoiding intravascular volume overload.~   "
139749|NCT01225627|"~     This is a single-centre randomized controlled clinical trial which will enroll COPD patients~     in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV, hospitalized~     due to acute exacerbation. Patients will be randomised in a 1:1 fashion to intervention~     group, which will have care organized by discharge coordinator, and control group which will~     receive care as usual. The primary endpoint of this study is time to hospitalization due to~     COPD worsening. Data will be collected at baseline, at the time of hospital discharge, and~     at following time-points after the hospital discharge: 48 hours, 7-10 days, 30 days, 90~     days, and 180 days.~   "
139781|NCT01225198|"~     The investigators hypothesis is that a new, revised formulation of a vitamin/mineral~     supplement will result in:~        1. improvement of nutritional status in some children/adults with autism, and~        2. reduction of some of the symptoms of autism in some children~   "
139740|NCT01225744|"~     A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in~     solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal~     cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.~      ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival~     (PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic~     disease after chemotherapy, Time to progression (TTP).~      POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal~     cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology~     and adequate renal and liver function Written informed consent and able to attend follow-up~     for at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan~     (day 1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3~     weeks every 4 weeks.~      DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up~     will continue until death or for a minimum of 3 years~   "
139741|NCT01225731|"~     This is a response-driven study of tildrakuzumab for the treatment of moderate to severe~     chronic plaque psoriasis. The primary study hypothesis is that one or more doses of~     tildrakizumab will be superior to placebo for the treatment of psoriasis.~   "
139742|NCT01225718|"~     This is a retrospective chart review of all patients cared for at Monroe Carell Jr.~     Children's Hospital at Vanderbilt including the following:~        -  patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or~          hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under~          23 years of age at time of diagnosis in order to ascertain the associated symptoms,~          management and outcome of all episodes of non-neutropenic fever.~        -  to identify a subset of low-risk patients that can be safely managed without use of~          empiric antibiotics.~   "
139743|NCT01225705|"~     Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection~     recommend a combination antiretroviral regimen composed of two nucleoside reverse~     transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside~     reverse transcriptase inhibitor.~      The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine~     and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine)~     and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has~     dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens~     and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may~     necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose~     adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals~     than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term~     efficacy.~      The overall intention of this trial is to examine in a non-inferiority design the safety and~     efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected~     patients. The standard of care used in this study will be atazanavir/ritonavir. All patients~     will in addition receive a fixed combination of tenofovir and emtricitabine.~      The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.~   "
139744|NCT01225692|"~     The goals of this study are to identify outcome indicators of optimal care for brain injury~     patients, including pre-hospital care, prompt delivery to neurosurgical care and access to~     early rehabilitation services. Nova Scotia's centralized Neurosurgical services and~     integrated provincial Emergency Health Services provide a rich opportunity to construct a~     cohesive, integrated data management system. This system will allow us to answer important~     research questions related to the outcomes, care and prevention of brain trauma.~      Retrospective data collection The retrospective arm of the BTO study has created full data~     sets and care pathways from multiple sources covering the continuum of brain trauma care.~     Investigators continue to analyze this large amount of data and prepare it for publication.~      Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been~     considered for enrollment in the BTO study.The prospective arm of the BTO study has 52~     patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients~     are participating in long term follow up at 6, 12 and 24 months post injury for assessment~     of qualitative and quantitative outcomes. Completion of patient follow up will be in June~     2009.~   "
139745|NCT01225679|"~     Congenital central hypoventilation syndrome (CCHS) is a rare disorder of respiratory control~     characterized by ventilatory impairment that results in arterial hypoxemia. Although~     patients typically present this disease as newborns and rarely in later infancy, there have~     been reports of patients presenting with CCHS in adulthood.~      The present study reports a unique familial case in which the father (proband) presented~     late-onset CCHS with an expansion mutation of the Phox2B gene that was confirmed by genetic~     analysis. Surprisingly, the proband did not report any manifestation of the disease during~     childhood, and the disease progressed following an insidious course until adulthood. At the~     time of diagnosis, he did not present signs of pulmonary hypertension and right-side heart~     failure. The patient responded well to nocturnal invasive ventilation. In contrast, his son~     presented CCHS as a newborn with the full complement of symptoms while his daughter did not.~      The present report shows that CCHS cases characterized by a mutated Phox2 gene can progress~     without many symptoms and that the treatment approach used here was efficient for~     controlling the course of the disease. Furthermore, this case indicates that incomplete~     penetrance can occur. Genetic screening of family members is mandatory to evaluate the~     reproductive risk of the disease, especially because asymptomatic mutation carriers may be~     at high risk to develop the disease and transmit it to the next generation.~   "
139746|NCT01225666|"~     This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics~     (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an~     every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient~     Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional~     extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose~     selection for future trials.~   "
139747|NCT01225653|"~     Randomized double-blinded two-year intervention study with topical application of~     latanoprost or placebo eye drops in patients with diabetic retinopathy.~   "
139748|NCT01225640|"~     PNU-100480 is being developed for the treatment of both drug resistant and sensitive~     tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480~     when given for 14 days to treatment-naive patients with drug-sensitive pulmonary~     tuberculosis.~   "
139750|NCT01225614|"~     This is a multicenter randomized controlled open labeled study testing efficacy and~     tolerance of early launching of night non invasive ventilation in patients with myotonic~     dystrophy type 1(DM1). The object of this project is to estimate the effects of the early~     introduction of non invasive ventilation on the arisen of complication (non expected~     hospitalization, tracheostomy even death) with regard to a simple respiratory follow-up in~     patients affected by myotonic dystrophy.~   "
139751|NCT01225601|"~     Study objectives:~        -  To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell~          histiocytosis~        -  To assess the impact of tobacco discontinuation~        -  Study Design Multicentric prospective cohort study~        -  Main endpoint: Pulmonary deterioration~        -  Sample size : 40 patients~   "
139752|NCT01225575|"~     This is a prospective, randomised, open label, multicentre Phase II clinical trial to~     investigate the efficacy and safety of the treatment of large defects with 3 different doses~     of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in~     subjects with cartilage defects of the knee.~      After screening visit patients were booked for arthroscopy and had their cells harvesting~     from healthy cartilage. After the arthroscopy the patients were randomised in one of the~     three dose-groups. The cells are cultivated for 8-10 weeks in vitro to develope~     3-dimensional spheroids, that are transplanted in an open knee procedure (treatment~     surgery)into the defect. Patients of all dose groups subsequently followed the same~     rehabilitation program and had post-surgery visits. The 12-month-visit is defined as final~     assessment. Then patients have follow-up assessments up to 60 months.~   "
139753|NCT01225562|"~     This study is being carried out to see if a new drug called ticagrelor given twice daily in~     addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death~     from heart disease, heart attack, or stroke).~   "
139754|NCT01225549|"~     The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild~     asthma challenged with an inhaled allergen.~   "
139755|NCT01225536|"~     This is an open-label, Phase 1, dose escalation study of oral ARQ 736 administered to~     subjects with advanced solid tumors harboring the mutation. The study is designed to explore~     the safety, tolerability, pharmacokinetics and pharmacodynamics of ARQ 736 and to define a~     recommended Phase 2 dose of ARQ 736.~   "
139756|NCT01225523|"~     To assess whether or not a perioperative therapy with surgery can improve the outcomes among~     patients with potentially curable squamous carcinoma of esophagus as compared to a~     preoperative chemotherapy followed by surgery~   "
139757|NCT01225510|"~     Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is~     important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be~     important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884~     (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that~     PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme~     (GBM).~   "
139758|NCT01225497|"~     Chronic pain and disability are unfortunately common in Achilles tendon pain. Outcome after~     surgery is often poor. Also tendon pain can be resistant to treatment and may lead to~     cessation of hobbies or careers.~      Recently eccentric exercise (defined as muscle loading where tension develops as physical~     lengthening occurs) has become a cornerstone in managing tendon pain due to an increasing~     amount of favorable research. Eccentric exercises are considered to be non-invasive, safe,~     and appear to be important for a successful outcome.~      One exercise program has been extensively adopted in research and clinical practice for~     Achilles pain. It recommends individuals perform 180 repetitions a day. However there~     appears to be little scientific rationale for this number. Consequently there may be~     significant implications for patient compliance, satisfaction, and overall treatment~     efficacy in a strategy which is encouraged to be uncomfortable.~      Fifty two adults (18-70 years old), with mid-Achilles tendon pain will be randomised to~     standard treatment (180 repetitions) or to a group where individuals are allowed to do what~     they can. Participants will be recruited from participating physiotherapy departments~     (health centres and hospital departments) across NHS Forth Valley. All individuals will be~     required to complete the same type of eccentric exercise for six weeks attending an initial~     assessment and two follow-up appointments at three and six weeks. Thereafter participants~     will be discharged if better, or continue with individual care where appropriate.~      It is hoped this pilot study will establish if future larger scale investigation is~     warranted examining whether it is necessary to subject individuals to 180 repetitions a day~     in an activity recommended to be uncomfortable. Also will participant satisfaction differ~     between exercise groups? If further investigation is warranted this pilot may provide~     population specific data for future sample size calculations, and may provide a suitable~     methodology for such investigations.~   "
139759|NCT01225484|"~     The purpose of this study is to compare two accepted methods of pain control in knee~     arthroplasty surgery.The first method combines the periarticular injection of ropivacaine~     with continuous blockade of the femoral nerve.The second method uses periarticular~     infiltration of ropivacaine in combination with an bolus of ropivacaine into an~     intraarticular catheter placed intraoperatively followed by a continuous intraarticular~     infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and~     oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)~   "
139760|NCT01225471|"~     The purpose of this study is to evaluate the safety and clinical efficacy of novel peptide~     vaccination for advanced prostate cancer~   "
139761|NCT01225458|"~     The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly~     patients aged over 75 years with renal insufficiency stage 5 will be included in the study~     after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in~     the exclusive nephrology follow-up arm will continue their usual follow-up; 250 patients~     in the geriatric follow-up arm will have both their usual nephrology follow-up and a~     geriatric follow-up.~      The aim of the study is to determine if a systematized gerontologist evaluation delay the~     occurrence of a composite primary endpoint : death, dementia, depression and severe~     dependency. The hypothesis is that the functional and vital prognosis of a patient with~     renal insufficiency depends not only on common and classical factors but also on cognitive~     and psychological functions and dependence, particularly in elderly patients.~   "
139779|NCT01225224|"~     A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of~     ASP015K in healthy nonelderly men.~   "
139780|NCT01225211|"~     The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and~     pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with~     ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the~     F508del-CFTR mutation.~   "
139879|NCT01223911|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate the~     safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the~     body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).~   "
139762|NCT01225445|"~     Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in~     the world. The treatment of IgA nephropathy with normal renal function and minimal~     proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce~     proteinuria and retard the rate of decline of renal function in chronic proteinuric~     nephropathies, including IgA nephropathy. The investigators conduct a randomized control~     study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy.~     Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited.~     They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria~     and renal function will be monitored. This study will explore the effects of ACE inhibitor~     in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent~     renal failure.~   "
139763|NCT01225432|"~     To assess the carryover effect of an innovative new gait training program on physiological~     and functional gait performance in persons with a traumatic lower extremity amputation. A~     second objective is to clarify the relationship between gait biomechanics (joint and sgment~     kinematics and energy cost.~   "
139764|NCT01225419|"~     This is a prospective Phase II, monocentre study.~   "
139765|NCT01225406|"~     This is an observational cohort study of virologic and immunologic outcome after at least 48~     weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be~     enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral~     (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy~     and second line PI-based therapy. Such regimens may contain new drugs or drug classes such~     as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study~     will help the Thai government in planning its strategy to provide third line ARV therapy to~     children within the national program.~   "
139766|NCT01225393|"~     This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group,~     multicenter study enrolling patients with active rheumatoid arthritis (RA).~   "
139767|NCT01225380|"~     This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of~     response-guided duration of therapy with GS-9190 and GS-9256 in combination with~     Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and~     safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and~     Ribavirin (Copegus®) will be evaluated.~   "
139768|NCT01225367|"~     The study is a prospective open evaluating study of Ultrasound/Doppler application to the~     chest cavity intended to detect and characterize pathologies of the pulmonary and~     cardio-vascular system.~      The system is a noninvasive non-imaging device designated to monitor flow and movement~     velocity and display the data continuously.~   "
139769|NCT01225354|"~     The purpose of this study is to determine if Radiesse injections to the cheeks result in an~     altered and improved first impression and self esteem.~   "
139770|NCT01225341|"~     The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A~     as a preventative measure for Herpes Labialis.~   "
139771|NCT01225328|"~     This project will develop and preliminarily evaluate an intervention to assist young-middle~     adult rural breast cancer survivors to overcome functional impairments related to their~     cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social~     and vocational responsibilities and recreational interests and are at increased risk of~     developing long-term difficulties performing these valued activities (participation~     restrictions). Rural cancer survivors are medically underserved and due to distance and~     geographic isolation face significant barriers to accessing traditional rehabilitation~     services. Alternative rehabilitation approaches are sorely needed for this population. Based~     on previous research with cancer and other medical populations a working draft of a~     treatment manual using a telephone-delivered Behavioral Activation and Problem Solving~     (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized~     clinical trial, additional work must be completed. The specific aims of this study are to a.~     refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the~     BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily~     assess the immediate and maintenance effects of BA/PS, and e. examine mediators and~     moderators of BA/PS effects based on our Self Regulation model of functional recovery. 188~     young-middle adult breast cancer survivors will be screened for participation restrictions~     following cancer treatment and 40 survivors with participation restrictions will receive~     BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness~     and interviewed regarding their experiences during treatment to provide information for~     refining the manual. The long-term objective of this line of research is to develop~     effective and feasible treatments for the medical and psychosocial consequences of cancer~     and its treatment in medically underserved cancer survivors (e.g., rural populations).~   "
139772|NCT01225315|"~     This study will assess the efficacy and safety of ACT-129968 in subjects with partly~     controlled asthma on reliever therapy only.~   "
139773|NCT01225302|"~     The primary objective of this study is to assess the safety and pharmacokinetics of~     linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with~     carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell~     lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor~     activity in the subjects as first-line treatment.~   "
139774|NCT01225289|"~     The aim of this study is to study the comparison between the effects of supplementation with~     25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system~     and Th1/Th2 balance in patients with Multiple Sclerosis.~   "
139775|NCT01225276|"~     NewGam (current working title for a new IGIV formulation) is a newly developed human normal~     immunoglobulin solution ready for intravenous administration (IGIV). This study will~     evaluate the safety and efficacy of three different dosages of NewGam 10% in patients with~     Chronic Inflammatory Demyelinating Polyradiculoneuropathy.~   "
139776|NCT01225263|"~     The investigators are studying if taking simvastatin and vitamin D together will help~     prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to~     treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a~     vitamin found in certain foods like some types of fish, and in nutritional supplements. This~     study is 9 months long. Some people who participate will receive simvastatin and vitamin D,~     and some people will receive a placebo. A placebo is a sugar pill that looks like~     medication but does not have any active ingredients in it.~      The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the~     number of migraines people who have episodic migraine get.~   "
139777|NCT01225250|"~     The purpose of this study is to determine efficacy, safety, and ease of cartilaginous~     grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts~     as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal~     extension (CSE) graft.~   "
139778|NCT01225237|"~     A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo~     for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate~     its safety.~   "
139782|NCT01225185|"~     Neurological injury after elective shoulder surgery in the beach chair position is thought~     to result from cerebral hypoperfusion and should therefore be preventable by appropriate~     hemodynamic monitoring and management. This proposal will use a system to continuously~     monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets~     in patients in the beach chair position, compared with a control cohort having orthopedic~     surgery in the lateral decubitus supine position. Autoregulation data will be compared~     against a new, highly specific and sensitive serum biomarker of neurologic injury, glial~     fibrillary acid protein, and postoperative neurocognitive testing results.~   "
139783|NCT01225172|"~     The purpose of this study is to evaluate oral doses of BMS-754807 in combination with~     letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic~     hormone receptor positive breast cancer subjects who have progressed with prior~     non-steroidal aromatase inhibitor treatment.~   "
139784|NCT01225159|"~     To determine whether intraoperative tight glycaemic control can reduce postoperative~     infection, morbidity and mortality~   "
139785|NCT01225146|"~     The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg~     in patients with ischemic CRVO who have been either previously treated with ranibizumab or~     treatment naïve.~   "
139786|NCT01225133|"~     The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and~     treatment compared to conventional standard care in patients with OA of the knee.~   "
139787|NCT01225120|"~     The purpose of this repeated measures design gait training study is to develop and~     quantitatively assess the effectiveness of a virtual reality training environment using~     real-time feedback for modification of pelvic motion during gait.~   "
139788|NCT01225107|"~     Bacterial infections are a common complication in patients suffering from burns. These~     infections can cause significant morbidity and often mortality. Antimicrobial resistance~     coupled with the prevalence of burn-related infections warrants the identification of~     alternative substances in the treatment of burn-related infections. The cranberry has been~     examined as a potential agent in the prevention of other types of infections and it appears~     to have anti-adherence effects on bacteria. In addition, the cranberry has demonstrated~     general inhibitory effects against some types of bacteria suggesting that it may be a useful~     agent in the prevention of bacterial infections in burn patients. The purpose of the present~     study is to investigate the effect of cranberry extract on the incidence of infections in~     burn patients.~   "
139789|NCT01225094|"~     The purpose of this program of research is to determine whether curcumin, a natural health~     product, can prevent acute kidney injury and other complications after elective AAA repair.~     If proven safe and effective, curcumin is an inexpensive intervention which can be readily~     applied to almost 50,000 AAA repairs performed worldwide each year. New knowledge about this~     intervention may also guide its use in other surgical and medical settings to prevent~     complications to the kidneys, heart and other organs.~   "
139790|NCT01225081|"~     This study is to evaluate the efficacy and safety after concomitant administration of~     ASP1941 and pioglitazone in patients with diabetes mellitus.~   "
139791|NCT01225068|"~     Low back pain is a public health problem affecting between 70-85% of adults at some time in~     their life. This study is being done to study the safety and effectiveness of the drug~     Milnacipran in treating chronic low back pain.~   "
139792|NCT01225055|"~     Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the~     effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on~     bone mass.~   "
139793|NCT01225042|"~     Background:~      The incidence of gastrointestinal infections is very high. In European countries 10-25% of~     the population suffers from at least one foodborne infection per year. Probiotics may~     strengthen human resistance to gut infections as they may beneficially modulate the~     intestinal microbiota composition and activity, and the immune function upon intestinal~     infection.~      Aim:~      To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli~     (ETEC).~      Study design:~      The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with~     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs~     placebo on several infection markers in response to an ETEC challenge is investigated.~     Participants will be randomly assigned to the probiotic or placebo group (n=21 per group).~     Subjects will be instructed to maintain their habitual food intake, but to standardize their~     dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally~     infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food~     research; dose will be 10E10 CFU). This ETEC strain induces mild and short-lived infectious~     diarrhea symptoms. Before and after infection, a diary will be kept to write down all food~     and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also~     be used for daily recording of bowel habits and frequency and severity of gastrointestinal~     complaints. Blood is sampled for immune response analyses and multiple faecal samples are~     collected to quantify several infection- and immune system markers, to determine probiotic~     excretion, and to verify dietary calcium intake.~      Study population:~      Healthy males of 20-55 yrs of age.~      Interventions:~      Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material~     powder of identical appearance).~      Primary outcomes:~      Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per~     day).~      Secondary outcomes:~      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal~     complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic~     persistence and levels of opportunistic pathogens in the endogenous microbiota.~   "
139794|NCT01225029|"~     Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and~     42 weeks gestation who develop difficulty breathing during the first days of life when no~     specific cause of the breathing difficulty can be identified. Little is known about why some~     babies develop TTN, and there have not been many formal studies of the best way to take care~     of babies with this disease. Babies with TTN get better on their own within three to five~     days after birth, but may require extra oxygen to breath well.~      Most physicians believe that the symptoms of TTN are related to poor clearance of fluid from~     the newborn's lungs. Babies with TTN have extra fluid visible on chest x-ray. Diuretics,~     medicines that can help clear extra lung fluid in adults and in babies with extra lung fluid~     for other reasons, do not to help babies with TTN. Babies with TTN need intravenous fluids~     to be healthy because they breathe too fast to be able to eat. Breastfed babies only get a~     very small amount of fluid in the first few days of life, as it normally takes several days~     for a new mother to begin producing breastmilk. No one has yet examined whether giving~     babies with TTN an amount of fluid similar to the small amount they would receive if they~     could breastfeed would help them recover from TTN faster.~      In this study, the investigators compare whether giving newborns standard intravenous~     fluid or amounts of intravenous fluid more close to what a breastfed baby would receive~     speeds recovery in newborns with TTN.~   "
139795|NCT01225016|"~     This study will evaluate thyroid nodules using specialized ultrasound imaging methods.~   "
139796|NCT01225003|"~     In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy~     (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection~     of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in~     optimal choice and planning of treatment.~      Patients treated with gliomatous brain tumours are included voluntarily. They undergo one~     imaging session on a 3T MR scanner prior to treatment.~      DKI data are quantitively analyzed in order to estimate specific parameters in normal~     appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed~     quantitatively and qualitatively with peak integration, ratio calculation and classification~     algorithms. Histological confirmation is obtained at subsequent surgery.~      Information from this study can be of significant importance in avoiding brain biopsies.~     Furthermore, information on microscopic tumour spread can be used during neurosurgery or in~     radiotherapy planning. An important advantage of these advanced MR techniques is the~     non-invasivity and the lack of ionizing radiation, two important issues in this relatively~     young patient population.~   "
139797|NCT01224990|"~     The aim of the study is to assess the value of whole body diffusion weighted MR imaging~     (WB-DWI) as a non-invasive method. On one hand for pretreatment lesion detection and~     post-therapeutic tumor recurrence but also for early therapy monitoring with the intention~     to early identify patients with a poor tumor response. Our research group demonstrated that~     this technique is accurate in patients with head and neck cancer it could differentiate~     between viable tumor tissue and inflammatory or necrotic tissue at variable time points~     after completion of radiotherapy. In the literature it is stated that DWI can also predict~     the response to chemotherapeutic therapy. This is only true for focal MRI images (eg only in~     liver). This study aims to determine whether the whole body technique can efficiently be~     used because the distribution of metastases is systemic. The study includes two phases: In a~     first phase, a baseline study will be conducted; all possible injury types will be gathered~     to determine the variability in signal characteristics to finally determine appropriate~     thresholds to differentiate between benign and malignant lesions. This should allow us later~     on to perform prospective studies. In a second phase, different applications such as:~        -  pretherapeutic staging~        -  Detection of post-therapy recurrence~        -  Early evaluation of systemic cytotoxic therapy.~      The results of the DW-MRI will be compared with those of PET, CT and conventional MRI which~     are now routinely performed for the diagnosis of colorectal tumors. The scans will be~     performed in a group of patients on a 3 Tesla MR system. This system is fully approved by~     the European and American standards and the patients will not be exposed to radiation or~     contrast agents. In principle, all patients treated for gastrointestinal cancer were~     included after informed consent from the patient. This study is important to investigate~     whether DWI is accurate in the pre-therapeutic injury detection and staging of~     gastrointestinal tumors compared with PET / CT and DWI. In addition it is important to~     predict the outcome after therapy.~   "
139798|NCT01224977|"~     The main objectives of the study are:~      1. To unravel the importance of molecular phenotyping in predicting the response to~     antimicrobial therapy with potential anti-inflammatory potency~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the~     basis for our current project based on the following hypotheses:~        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels~          can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist.~        3. These subgroups have different responses to anti-microbial therapy with potential~          anti-inflammatory potency (macrolides).~   "
139799|NCT01224964|"~     The main objectives of the study are:~      1. To unravel the importance of molecular phenotyping in predicting the response to~     classical anti-asthma treatment (leukotriene antagonists)~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the~     basis for our current project based on the following hypotheses:~        1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels~          can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist.~        3. These subgroups have different responses to anti-leukotrienes.~   "
139800|NCT01224951|"~     The main objectives of the study are:~      -to unravel the importance of molecular phenotyping in predicting the response to classical~     anti-asthma treatment (inhaled corticosteroids)~      The investigators have developed a non-invasive technique based on mRNA analysis of induced~     sputum that enables us to study airway inflammation in detail. This technique forms the~     basis for our current project based on the following hypotheses:~        1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as~          reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels~          can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.~        2. Based on our previous research and preliminary data that non-Th2 asthma can be further~          divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2,~          Th17 or Th1 characteristics also exist. The investigators hypothesize that the~          epithelial cell cytokine, TSLP, can be increased as an early marker of airway~          inflammation in this latter group.~        3. these subgroups have different responses to anti-inflammatory treatment.~   "
139801|NCT01224938|"~     The main objectives of the study are~        1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways~          of healthy subjects and clinically different asthma patients, based on a non-invasive~          procedure of sputum induction. Patients will be different in function of age, in~          relation to the trigger (eg aspirin, without or with association with polyposis),~          without or with underlying atopic sensitization or different in the type of underlying~          inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis~          of molecular phenotyping in the patients.~        2. to study the usefulness of asthma molecular phenotyping (by following the balance~          between the inflammatory markers on the one hand and the regulatory markers on the~          other hand) in asthma guidance (longitudinally).~      The final goal of this project is then to develop a sputum non-invasive biomarker array that~     can be used to distinguish the different inflammatory asthma phenotypes and that can predict~     steroid resistance and/or sensitivity to other anti-inflammatory medication, using a~     non-invasive technique that can be used also at young age and repetitively.~   "
139802|NCT01224925|"~     The purpose of this study is to investigate whether MTA is more effective than a~     conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature~     molar teeth with a carious pulpal exposure.~   "
139803|NCT01224912|"~     The object of this study is to determine variables associated with therapy-success of a~     cognitive behavioral self help intervention for insomnia. In this study all participants~     receive an online self-help CBT manual consisting of information (psycho-education) about~     sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a~     popular scientific website to fill out online questionnaires. Participants will be measured~     4, 16, and 40 weeks after intervention with the same questionnaires.~   "
139804|NCT01224899|"~     The investigators sought to evaluate the feasibility and safety of surgical sympathetic~     blockade in systolic heart failure patients and secondary to assess its cardiovascular~     consequences.~   "
139805|NCT01224886|"~     Insulin resistance is a crucial factor for the development of type 2 diabetes and a major~     health problem for older adults. It is the principal mechanism by which obesity is~     considered to increase the risk for type 2 diabetes and is a key feature of the metabolic~     syndrome. The elevated prevalence of obesity and type 2 diabetes in the older population has~     important consequences on the morbidity and mortality as well as on the economic burden on~     society. Controversy currently exists as to whether or not aging contributes to insulin~     resistance. Many potential factors confound the association between aging and insulin~     resistance, including obesity and physical inactivity.~      Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose~     tissues such as in the liver (intrahepatic lipids) and within the muscle fibers~     (intramyocellular lipids), are positively associated with obesity and insulin resistance.~     Furthermore, the accumulation of intracellular lipids is often cited as being a key~     determinant in the underlying mechanisms of insulin resistance. In addition of playing an~     important role in obesity and type 2 diabetes, these ectopic fat depositions are also~     observed in common conditions such as aging and physical inactivity.~      The intervention trial will test in skeletal muscle, liver and heart of sedentary obese~     volunteers, normal weight volunteers and masters athletes, the overall hypotheses that~     exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites~     is a primary factor that predicts the improvement in insulin resistance.~   "
139806|NCT01224873|"~     Breast cancer can metastasize to the bones, which leads to another treatment if bone~     metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is~     superior to bone scintigraphy with technetium. On the other side, the investigators would~     like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone~     metastases in patients with breast cancer.~   "
139807|NCT01224860|"~     In renal transplant recipients, residual renal insufficiency combined to the effects of~     immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin~     activity and may contribute to several of the abnormalities associated with the metabolic~     syndrome, such as hypertension, glucose intolerance and hyperlipidemia. In turn, insulin~     resistance, hypertension, hyperglycemia and dyslipidemia may importantly contribute to the~     excess cardiovascular risk of renal transplant patients (an excess comparable to that of~     diabetes subjects with over diabetic nephropathy)and may also accelerate progressive renal~     function deterioration and promote graft loss. Thus, amelioration of the insulin activity~     and of the related metabolic syndrome is a key component of treatments aimed to improve~     patient and graft survival in renal transplant recipients. Recently, drugs such as~     peroxisome proliferators-activated receptor-gamma activators, that ameliorate insulin~     sensitivity and metabolic syndrome, have become available.These agents, however, can provoke~     fluid retention, weight gain, edema and, in some cases, heart failure.~      Recent studies showed that telmisartan, an angiotensin II type 1 receptor antagonist, in~     addition to block the angiotensin II type 1 - a key surface receptor involved in the~     regulation of blood pressure - may also activate peroxisome proliferators-activated~     receptor-gamma activators, thus improving some of the features of the metabolic syndrome.~     Thus telmisartan may substantially reduce the overall cardiovascular and renal risk of renal~     transplant recipients by ameliorating some of the modifiable components of the metabolic~     syndrome. On the other hand, telmisartan is devoid of the adverse effects of peroxisome~     proliferators-activated receptor-gamma activators such as fluid retention, and has therefore~     a remarkably better risk/benefit profile. Thus, whether telmisartan in addition to the~     beneficial effects of a reference angiotensin II type 1 receptor antagonist (such as~     losartan) may offer adjunctive advantages related to improved insulin sensitivity in renal~     transplant patients on chronic therapy with steroids and/or calcineurin inhibitors, is worth~     investigating.~   "
139808|NCT01224847|"~     Patients with neovascular age-related macular degeneration (AMD) scheduled to receive~     intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical~     anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10~     seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be~     conducted immediately after and 15 minutes after the injection, to assess for pain.~   "
139809|NCT01224834|"~     The purpose of this study is to determine the safety and tolerability of several doses of~     ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic~     rhinitis to ragweed.~   "
139810|NCT01224821|"~     Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry,~     dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients~     with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective~     of this study is to demonstrate that each site could accurately conduct the whole body~     dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody.~     Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of~     Iodine-131 Anti-B1 Antibody.~   "
139811|NCT01224808|"~     The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding~     episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low~     or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term~     efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children,~     adolescents, and adults with VWD in whom treatment with a VWF product is required for~     prophylactic therapy, haemostatic control during surgery, or control of a non-surgical,~     spontaneous, or traumatic bleeding event.~   "
139812|NCT01224795|"~     This is a study to evaluate the efficacy and safety of a single dose of intravenous~     peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.~   "
139813|NCT01224782|"~     The aims of this post-marketing observational study (PMOS) are to evaluate the time period~     needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the~     initial values and to provide data on the tolerability and compliance of treatment with~     Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in~     patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical~     practice.~   "
139814|NCT01224769|"~     This retrospective study collects and evaluates the clinical experience reached in Italy on~     the use of bendamustine alone or combined with rituximab as treatment of patients with~     relapsed or refractory chronic lymphoproliferative disorders.~   "
139815|NCT01224756|"~     The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL),~     three times daily (TID), in the treatment of pain and inflammation in patients with acute~     tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.~   "
139816|NCT01224743|"~     Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient~     supplementation that may offer cardioprotective effects. This study assessed the effects of~     encapsulated fruit and vegetable juice powder concentrates on endothelial function and~     cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover~     clinical trial with three treatment arms.~   "
139817|NCT01224730|"~     This is a Phase I study which will analyze any food-drug effects as well as QTc effects of~     perifosine. Safety and efficacy will also be evaluated.~      Patients who complete the first 24 days on single agent perifosine may have the opportunity~     to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine +~     perifosine; or 3) switch to the combination of sorafenib + perifosine.~   "
139818|NCT01224717|"~     This study is designed to provide information about the bone-anabolic response of PTH134~     when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide,~     the active ingredient in PTH134.~   "
139819|NCT01224704|"~     Background:~      - One area in which obese and lean individuals may be different is how their bodies handle~     water balance and thirst. Studies done in animals suggest that individuals with greater body~     fat may tolerate periods without water better than lean animals. Other research has found a~     link between the ability to tolerate periods without water and increased body weight.~     Researchers are interested in studying whether the ability to tolerate periods without water~     and ability to feel thirst might differ in lean versus obese individuals.~      Objectives:~      - To evaluate the effects of water deprivation and feelings of thirst in lean and obese~     individuals.~      Eligibility:~      - Healthy individuals at least 18 years of age who are either lean (body mass index less~     than 26 kg/m(2)) or obese (body mass index at least 35 kg/m(2)).~      Design:~        -  Participants will be screened with a medical history, physical examination, and blood~          and urine tests.~        -  Participants will spend the entire study (13 days) as inpatients at the National~          Institutes of Health Clinical Center.~        -  Participants will have the following tests and procedures:~        -  Body composition assessment (using low-level x-rays) to determine the percentage of fat~          tissue in the body.~        -  Oral glucose tolerance test (similar to that often used to diagnose diabetes).~          Individuals who are suspected to have diabetes will not be allowed to continue with the~          study.~        -  High salt infusion test, in which an infusion of saline (salt water) will be given for~          2 hours and participants will respond to questions about how hungry and thirsty they~          feel during the procedure.~        -  Water deprivation test, in which participants will go for 24 hours without water or~          food and respond to questions about how hungry and thirsty they feel.~        -  24-hour stay in a metabolic chamber to determine how many calories participants burn in~          a day.~        -  A series of questionnaires about participants' eating habits, feelings about food, and~          personal feelings, as well as computer-based tests involving the performance of various~          tasks.~        -  Measurement of free-living energy using doubly-labeled water, in which participants~          will drink a sample of water with extra-heavy atoms of hydrogen and oxygen to evaluate~          the amount of water in the body.~        -  24-hour urine collection.~        -  Frequent blood samples, urine collection, and fat tissue biopsies during the various~          study procedures.~        -  After the end of the 13-day study, participants will return after 1 week for a final~          urine collection.~   "
139820|NCT01224691|"~     Background:~        -  Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract~          infections, and is frequently responsible for hospital visits in infants and children.~          It can also trigger severe breathing problems for individuals who have asthma, but~          these infections are generally better tolerated in non-asthmatics. Some research~          suggests that lack of an efficient immune system response in people with asthma may~          make it difficult for the body to fight the effects of RSV.~        -  Transforming Growth Factor-beta (TGF-[beta]) is a chemical in the body that is more~          prevalent in the lungs of people with asthma and related respiratory disorders. More~          information is needed about the effects of TGF-[beta] and whether it makes individuals~          with asthma more prone to developing RSV. Researchers hope to use this information to~          determine possible treatments and therapies for individuals with asthma who contract~          RSV.~      Objectives:~      - To determine the possible role of TGF-[beta] in increased asthmatic susceptibility to RSV~     infection.~      Eligibility:~      - Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild~     asthmatics.~      Design:~        -  This study involves a screening visit and a study visit.~        -  Participants will be screened with a medical history and physical examination, as well~          as blood samples and a pulmonary function test.~        -  At the study visit, participants will receive mild anesthetic and have a bronchoscopy,~          in which researchers insert a bronchoscope through the participant s nose or mouth and~          into the lungs to examine the lungs and collect lung cells.~        -  Participants will be contacted by a research team member 24 36 hours after the~          bronchoscopy to ask about any side effects from the procedure.~   "
139821|NCT01224678|"~     RATIONALE: Vitamin D may help prevent breast cancer.~      PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers~     in female patients.~   "
139822|NCT01224665|"~     RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in~     patients with invasive bladder cancer. It is not yet known whether extended pelvic~     lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.~      PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see~     how well it works compared to extended pelvic lymphadenectomy in treating patients~     undergoing surgery for invasive bladder cancer.~   "
139823|NCT01224652|"~     The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy~     with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients~     with recurrent and metastatic gastric cancer who progress following first line therapy.~   "
139824|NCT01224639|"~     The purpose of this study is to assess the safety of DENVax in healthy adults when given as~     either a subcutaneous (SC) or intradermal (ID) injection at two dose levels (low and high).~     The vaccine will be given as two doses 90 days apart. Safety assessments include injection~     site evaluation and adverse events. The immune response generated after vaccination will be~     assessed up to 9 months after the first vaccination.~   "
139825|NCT01224626|"~     To collect the efficacy and safety information in subjects who have been treated with Zyvox~     (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate~     use in daily practice.~   "
139826|NCT01224613|"~     The purpose of this study is to compare the immunogenicity and reactogenicity of~     self-administered intradermal influenza vaccine (Intanza)to nurse-administered.~   "
139827|NCT01224600|"~     The purpose of this study is to determine the prevalence and risk factors, at the time of~     the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.~   "
139828|NCT01224587|"~     The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix~     placebo tablets in healthy male volunteers under fasting and fed conditions. The method~     which is used is an imaging technique.~   "
139829|NCT01224574|"~     The primary aim of the study was to assess whether D-Dimer level at entry or an increase of~     D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular~     events in patients with atrial fibrillation.~   "
139830|NCT01224561|"~     For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to~     nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or~     in obese patients by promoting weight gain, either in constitutional thinness (MC) by~     blocking it. The MC is a little known entity. These patients wish to grow for her and~     others. Can they? We have demonstrated abnormalities of hormones regulating appetite~     (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness~     is associated with osteoporosis in 25% of true MC who is 25 years old.~   "
139831|NCT01224548|"~     The purpose of this study is to study the potential benefits of low fat vegan diet in a~     randomized, controlled and multi-centered workplace setting, the investigators will enroll~     participants from 10 worksites of Government Employee Insurance Company (GEICO). After~     randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study.~     The vegan sites will receive low fat vegan diet instructions and weekly group sessions~     starting from year 1. no intervention is done to the control sites until the week 18 when~     the identical program will be given. At various time points, health measurements will be~     give to all participants.~   "
139832|NCT01224535|"~     Introduction: Iron deficiency anaemia remains a significant public health challenge.~     Localized food based approaches may offer a large opportunity to improve lives and address~     the widespread micronutrient deficiencies such as iron in affected households. Viable~     solutions where iron rich foods are not readily available may come through diversification~     approaches using foods such as amaranth grain reported to contain high iron content and good~     quality protein in conjunction with the use of in-home fortification.~      Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on~     improving diet quality, iron intake and status in children 12-59 months in a semiarid area~     in Kenya.~      Study population: The study population will comprise children aged 12-59 months in Migwani,~     within the larger Mwingi district, Kenya. Mothers or principal caretakers will be~     interviewed on behalf of the children. In total, 270 children will be enrolled in the study.~      Study design:~      The study has a randomized controlled trial design conducted over a period of 4 months/16~     weeks.~      Treatment/hypothesis: All participating children will be required to take the provided~     porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments~     groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30~     maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder~     (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant~     difference in hemoglobin and iron status between the three groups.~      Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after~     intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be~     assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive~     protein (CRP) will be done at the participating laboratories.~      Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this~     study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are~     the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and~     tissue iron deficiency will be defined as serum transferrin receptor concentration of~     >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute~     inflammation and presence of malaria.~   "
139833|NCT01224522|"~     - Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL~     TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION~        -  Short Title: Visionaire Alignment~        -  Methodology: Monocentric, Single Blinded, Randomized Controlled Trial~        -  Study Duration: November 2010 to July 2014~        -  Study Centres: Leicester General Hospital, United Kingdom (UK)~   "
139834|NCT01224509|"~     The purpose of this study is to determine the effect of mifepristone on the expression of~     three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days~     gestational age.~   "
139835|NCT01224496|"~     The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on~     anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS),~     aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did~     not respond to available treatment options.~   "
139836|NCT01224483|"~     Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which~     unregulated activation of the complement system leads to significant ischemic morbidities~     with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared~     complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of~     PNH patients experience a clinically evident TE and 60% of patients without clinically~     diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk~     in most patients with PNH. Much of these data come from PNH patients from European descent.~     To understand the impact of TE in patients with PNH from non-European regions, we performed~     this study to evaluate the clinical characteristics of Korean patients with PNH.~   "
139837|NCT01224470|"~     Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting~     anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic~     agents result in prolongation of the duration of the sensory and motor blockade induced by~     hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block~     was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine~     on the low-dose spinal anesthesia for the transurethral surgery.~   "
139838|NCT01224457|"~     The pharmacogenomic profiles of drug metabolizing enzymes play an important role in~     pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure,~     is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It~     was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19~     polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19~     genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing~     strategy.~   "
139839|NCT01224444|"~     Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is~     considered the best test colorectal cancer screening. It allows resection of adenomatous~     polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence.~     Despite the potential benefit of screening colonoscopy recent studies have reported cases of~     colorectal cancers in a short interval after prior screening or surveillance colonoscopies.~     One possible cause of such interval cancers may be incomplete resection of adenomatous~     polyps and hence ongoing growth and cancer development in such lesions. Complete resection~     may be particularly important for polyps of at least 5mm in size as up 10% of such polyps~     higher risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or~     early carcinoma.~      Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is~     believed to be well standardized data on complete resection of adenomatous tissue are~     sparse. This may be related to the assumption that using a snare with electro-cautery will~     successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence~     completely remove and or destroy the lesion.~      The investigators are interested in examining how often sessile adenomatous polyps between 5~     and 20mm are completely removed using standard polypectomy snare. The investigation was also~     directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and~     20mm.~   "
139840|NCT01224431|"~     Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered~     lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing~     pain prior to lumbar puncture in infants.~      Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3~     months of age, presenting to the emergency department meeting clinical criteria for a lumbar~     puncture. All patients were administered the J-tip and randomized to either treatment with~     1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.~   "
139843|NCT01224392|"~     The investigators propose a randomized non-inferiority trial that compares preoperative~     Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated~     boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential~     with regard to toxicity and cost. The metabolic response of the tumor, as assessed by~     18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be~     used as a surrogate marker of cause specific outcome~   "
139844|NCT01224379|"~     Does a new topping-off device lead to a better clinical outcome compared to standard~     fusion? Does this device prevent the development of adjacent instability? Does radiological~     adjacent instability correlate with clinical outcome?~   "
139845|NCT01224366|"~     To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients~     with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.~   "
139846|NCT01224353|"~     The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom~     improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in~     Chinese diabetic patients with distal symmetric polyneuropathy (DSP).~   "
139847|NCT01224340|"~     The hypothesis was that an active distraction is more effective than a passive distraction~     in conjunction with procedural pain in children. The specific aim in this study was to test~     how an active distraction, serious gaming and a passive distraction, the use of lollipops~     influence pain, distress and anxiety in children during wound care.~   "
139848|NCT01224327|"~     The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem~     cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.~   "
139849|NCT01224314|"~     In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al~     demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis~     would produce a significant increase in systolic blood pressure at the end of the session,~     even though there were no clear effects on intra-dialytic blood pressure. The authors~     defined this post-dialysis blood pressure behaviour as rebound hypertension.~     Paradoxically, in animal models, other than in the context of end-stage renal disease,~     potassium is a vasodilator. Considering that the removal of potassium during the~     haemodialysis session could be theoretically modulated in profiles (as with sodium and~     bicarbonate), it was deemed suitable to delve deeper into this argument by studying, in~     detail, the (non invasive) hemodynamic repercussions of changes in the potassium~     concentration of the dialysate. Not being able to linearly modify the concentration, we~     decided to divide the dialysis session in 3 tertiles, randomising the patients to all~     possible dialysate sequences containing the usual concentration of potassium or two cut-off~     points at +1 and -1 mmol/l. Haemodynamic measurements were performed using a finger~     beat-to-beat monitor.~   "
139850|NCT01224301|"~     Purpose of the study. The purpose of the project is to evaluate the feasibility,~     acceptability, and cost effectiveness of providing influenza vaccine in schools to children~     in grades Kindergarten through 6th grade.~      Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of~     influenza vaccination in school children.~      Hypothesis 2: Higher intensity parent notification about school based influenza vaccination~     does not increase immunization rates compared to low intensity.~      Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost~     neutral.~   "
139851|NCT01224288|"~     This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential~     Therapy in Advanced Renal Cell Carcinoma Therapy: The START Trial).~      The goal of this clinical research study is to learn if dynamic contrast enhanced computed~     tomography (DCE-CT) scans can help researchers learn if the study drug received as part of~     study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.~   "
139852|NCT01224275|"~     The Study compares group based care versus individual given care-effects on patient~     satisfaction and health. Midwives will be randomized to either traditional antenatal care~     (Individual care) or group based antenatal care(intervention).~   "
139853|NCT01224262|"~     This study is designed to evaluate the safety, tolerability, and immune response of LIQ001~     mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations~     of subjects; healthy adult subjects 18 to 49 years of age and healthy elderly subjects 65~     years of age or older.~   "
139854|NCT01224249|"~     The primary aim of this study is to investigate, whether higher intake of selenium rich food~     items such as fish and shellfish, is associated with higher selenium blood levels.~      The secondary aim is to investigate the uptake of selenium from fish and shellfish and the~     incorporation of selenium from those foods into proteins in the human body. Furthermore, the~     impact of the natural variation in the genes that are responsible for the accumulation of~     selenium in the proteins will be investigated.~   "
139855|NCT01224236|"~     The purpose of this study is to determine if iron supplementation in addition to routine~     iron intake decreases the risk of developing anemia in preterm infants.~   "
139856|NCT01224223|"~     Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T~     cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to~     chronic inflammatory conditions such as cancer, leading to the induction of tolerance and,~     ultimately, tumor escape from immune surveillance.~   "
139875|NCT01223963|"~     This is a retrospective, multicenter chart review of medical records on the use of Macrolane~     for female breast enhancement.~      The primary objective is to evaluate the safety profile of Macrolane Volume Restoration~     Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement~     in clinical practice.~   "
139876|NCT01223950|"~     To research the prevalence and nature of DRP (Drug Related Problems) associated~     hospitalizations (hospitalizations due to problems\adverse effects of the medication~     treatment) .~      Analyzing the main reasons for DRP associated E.R admissions\hospitalizations. identifying~     drug involved and percentage of DRP associated hospitalizations.~      Monitoring the length of DRP associated hospitalizations. Evaluating LOS to hospitalized.~     Financial and other aspects will be measured.~   "
139877|NCT01223937|"~     A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to~     investigate the safety and efficacy of desmopressin oral melt tablets against placebo during~     3 months of treatment in adult females with nocturia.~   "
139878|NCT01223924|"~     This is a randomized double-blinded placebo-controlled，single-dose escalation trial in~     healthy volunteer.~   "
139857|NCT01224210|"~     This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety~     of an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with~     portopulmonary hypertension.~      Preliminary evidence suggests that ambrisentan is safe and effective in patients with~     portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms~     of dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure <35 mm~     Hg in order to make patients eligible for liver transplantation. Therefore, the primary~     endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular~     resistance (PVR).~      Eligible subjects will receive 5 mg ambrisentan once-daily for the first 4 weeks. After the~     initial 4-week period, investigators will increase study drug dose to 10 mg once daily (both~     5 mg and 10 mg doses are FDA approved). If 10 mg is not tolerated in the opinion of~     investigator, then the investigator may decrease the dose back to 5 mg once daily. Primary~     outcome is a change in both the 6MWD and in PVR from baseline to Week 24. Subjects will be~     monitored with liver function tests (LFT) every 2 weeks for the first 8 weeks, then every 4~     weeks thereafter. These safety laboratory tests may be performed at a local phlebotomy~     laboratory or at the Investigator clinic. In addition, the Investigator will assess each~     subject for safety and efficacy at Week 4, Week 12, and Week 24. Following Week 24, subjects~     will be assessed for safety and efficacy every 12 weeks. Patients will be followed for a~     total of 1 year. After 1 year, if the Investigator feels that continuing the treatment will~     be beneficial to the patients, they will be provided with ambrisentan by Gilead~     Pharmaceuticals, free of charge.~   "
139858|NCT01224197|"~     The purpose of this study is to assess the pharmacokinetics, safety and tolerability of~     single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics~     (PK) means how the drug is absorbed into the bloodstream, distributed in the body and~     eliminated from the body.~   "
139859|NCT01224184|"~     The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused~     Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among~     African-American young women relative to general health intervention.~   "
139860|NCT01224171|"~     This study in patients with moderately to severely active Crohn's disease is designed to~     establish the efficacy and safety of vedolizumab for the induction of clinical response and~     remission.~   "
139861|NCT01224145|"~     This study will assess pain intensity for the first 72 hrs after aggravated movement (cough)~     following Laparoscopic Inguinal or Umbilical Herniorrhaphy.~   "
139862|NCT01224132|"~     This study was designed to evaluate the efficacy of probiotics in the treatment of atopic~     dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but~     not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and~     serum total and specific IgE levels.~   "
139863|NCT01224119|"~     The current research study evaluates an investigational medical device called Amplex B2A(TM)~     Peptide Enhanced Ceramic Granules (Amplex) for use in foot and ankle fusion. Amplex is a~     synthetic bone graft material. The most frequently used graft material is bone collected~     from the patient (autograft). Autograft involves a secondary incision with the risks of~     infection and lasting pain.~      The purpose of this study is to determine if Amplex is a safe and effective alternative to~     autograft.~   "
139864|NCT01224106|"~     This multi-center, randomized, double-blind, placebo-controlled parallel-group study will~     evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety~     and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will~     be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.~     Participants who consent to be part of the sub study will undergo positron emission~     tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment~     is 104 weeks, with an option for an additional 2 years of treatment.~   "
139865|NCT01224093|"~     This prospective observational study will evaluate the safety of MabThera/Rituxan~     (rituximab) in combination with chemotherapy in patients with previously untreated or~     relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected~     from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.~   "
139866|NCT01224080|"~     A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked~     with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid~     can harm the tubes and uterus making implantation more difficult or harm the embryo.~   "
139867|NCT01224067|"~     This is a 16-week research study in which participants suffering from Social Anxiety~     Disorder (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD)~     for the first 8 weeks. If a participant remains symptomatic, he/she will enter the second~     phase of the study in which he/she continues taking Sertraline but also randomly receives~     either Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The~     purpose of this study is to determine the efficacy of adjunctive Seroquel in treating SAD.~   "
139868|NCT01224054|"~     The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the~     world. Since 1991, many international medical societies have established as recommendation~     for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or~     IMC > 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of~     them with the lose of weight due to the surgery. In front of the new anatomical condition~     from the gastrointestinal tract the patients present changes in food preferences and in the~     food intake, which include modifications in food choices, perception of hungry and satiety~     and in the tolerance to determinate food. These changes in food intake of the patients are~     observed mostly in the first year after the surgery an adaptive phase to a new condition.~   "
139869|NCT01224041|"~     This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid~     Arthritis patients who showed unsuccessful response against methotrexate.~   "
139870|NCT01224028|"~     This study is to evaluate efficacy and safety of tacrolimus in the patients with~     non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with~     tacrolimus (Prograf) or placebo.~   "
139871|NCT01224015|"~     This study will evaluate the safety and efficacy of botulinum toxin type A compared to~     placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for~     patients who successfully completed Study 191622-099.~   "
139872|NCT01224002|"~     The prevalence and severity of dental caries in incarcerated people who abuse drugs are~     unknown but an inmate reporting to the dental clinic typically presents with myriad~     findings: oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior~     teeth and interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding~     and clenching, and gingival inflammation. The primary risk factors for the development of~     caries appear to be the combination of xerostomia, frequent consumption of carbonated soft~     drinks, high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of~     these findings are seen in the other disease states, specifically in substance abuse cases,~     the diagnosis is often not clear. The objective of the project is to design a cross~     sectional comparative feasibility study that will estimate the prevalence, pattern, and~     severity of untreated dental decay for three types of inmates: methamphetamine abusers,~     substance abusers not identified as methamphetamine users, and non-substance abusers,~     focusing in on methamphetamine abusers as the highest risk group.~      Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter~     explaining the study purpose and its relevance to oral health in a correctional setting will~     be mailed to the inmate population at two Federal Bureau of Prisons' institutions who~     entered the prison system during the first half of 2009. Dublin, a female FCI located in~     Northern California and Butner, a male FCC located in North Carolina were the selected~     facilities due to the high incidence of drug abusers among their inmates. The letter, which~     will invite all inmates to participate in the study, will inform the inmate should they~     consent to participate in the study that they will have their existing dental record~     confirmed, Central File reviewed for DSM-IV diagnosis pertinent to the study, and that they~     will be given a study questionnaire. Positive responses to the invitation letters will be~     returned to Dr. Johnson at head quarters in Washington DC. The psychology division will code~     the volunteer inmates into the three study groups.~      Phase II. The first 30 chronologically documented volunteers in each study group category~     will be scheduled an appointment. A consent form will be read and explained to each inmate,~     in either English or Spanish as appropriate and his/her signature obtained as his/her~     informed consent.~      Each question on the study questionnaire will be read to the inmate volunteer and the~     Research Associate will record the answer. A retrospective comparative study will then be~     employed utilizing the inmate's initial dental intake exam (routinely administered by the~     Federal Bureau of Prisons' dental department). The dental chart will be abstracted for~     dental caries. The pattern of surface-specific dental caries (DFS index) will be described~     and analyzed. The focus will be on the levels of untreated and treated disease diagnosed in~     a 4-zone partition of the oral dentition, representing a modification of the zones~     identified in the Grainger's caries severity index scoring system as this partition allows~     focus on decay patterns of anterior tooth surfaces. The multivariate summary of disease~     levels within each zone will be derived and statistically compared across the three study~     groups using Hotelling's t2-test (the multivariate extension of the Student-t test). The~     results of the study will be used to do a preliminary assessment between methamphetamine~     drug abuse and oral health and determine whether a prospective clinical study is warranted.~   "
139880|NCT01223898|"~     This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics~     and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following~     extension study does evaluate the safety of nilotinib.~   "
139881|NCT01223885|"~     By performing a challenge with camel's milk in patients who are allergic to cow's milk, the~     investigators will examine if camel's milk is a safe alternative for these patients.~   "
139882|NCT01223872|"~     This two-part research study will compare childhood cancer survivors receiving specialized~     follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up~     care.~   "
139883|NCT01223859|"~     Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in~     the treatment of habitual snoring. The decision making process in the management of habitual~     snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to~     investigate the correlation of systematic clinical pretreatment oropharyngeal examination~     scores with the efficacy of interstitial RF surgery of SP in a multi-center study~   "
139884|NCT01223833|"~     The Logribmet study is a prospective study that evaluate grip strength changes in both hands~     of postmenopausal women with breast cancer receiving treatment with tamoxifen or an~     aromatase inhibitor. Patients included in the study will undergo a grip strength measurement~     and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6~     months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a~     predictor for the decrease in grip strength.~      IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.~   "
139885|NCT01223820|"~     The term idiopathic rhinitis (IR) is used in this study to describe a patient group with~     following characteristics: patients with complaints of nasal obstruction, sneezing and/or~     rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or~     paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders.~     These patients are non-smokers and do not use medication affecting nasal function. They have~     no beneficial effect of intranasal steroid spray (INS) treatment.~      The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR~     is largely unknown. Several hypotheses have been put forward. In general it is assumed that~     neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF~     are released from afferent neurons in the nasal mucosa after activation by unspecific~     stimuli and can be responsible for the symptoms of IR.~      For this group of IR-patients, there is until now only one treatment option: intranasal~     capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its'~     therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.~      The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces~     in that way nasal symptoms.~   "
139886|NCT01223807|"~     Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients~     with chronic obstructive pulmonary disease (COPD). Several studies have described an~     impairment in diaphragmatic mobility of COPD patients compared to age matched control~     subjects and it has been associated with increase in dyspnea, exercise intolerance and~     mortality. COPD patients also experiment a higher activity of the accessory breathing~     muscles, which greatly increases the work of breathing and dyspnea sensation.~      Breathing strategies have been considered an important component of pulmonary rehabilitation~     and refer to a range of techniques, including/which includes the diaphragmatic breathing~     (DB). The principal aim of DB is to improve the participation of the abdominal motion while~     reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality~     in the rehabilitation of COPD patients remains controversial. Despite the conflicting~     results, improvement of the abdominal motion and a reduction of thoracic excursion, during~     voluntarily DB, has been described as a common finding of several studies. The investigators~     hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this~     modification would relieve respiratory symptoms and improve exercise tolerance and the~     HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the~     effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic~     mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.~   "
139887|NCT01223794|"~     Goals and future prospects:~        1. To finish the survey of the high risk factor ratios and high incidence rates associated~          with falls among inpatient fallers.~        2. To investigate the risk factors associated with falls and the consequential analysis~          related to falls among inpatient fallers.~        3. A good precautionary measure of falls will reduce damages and injuries for the fallers,~          especially inpatients welfare. Our accomplishments of this research proposal will~          provide sufficient information and reference for the precautionary strategies~          associated with fall incidents. More importantly, the experiences and results will be~          further explored and shared among all other hospitals.~   "
139888|NCT01223781|"~     Objective/Rationale:~      The investigators objective is to demonstrate that an intervention program based on motor~     learning principles can be applied to train subjects with Parkinson's disease (PD) who~     suffer from freezing to walk in a way that minimizes the occurrence of freezing. Since~     sufficient motor learning capabilities are preserved in PD, the investigators hypothesize~     that an intervention program that targets the time periods just prior to an approaching~     freezing episode can modify the walking strategies so that the episode will now be averted.~      Project Description:~      The freezing burden will be quantified in subjects with PD before and after 6 weeks of~     training. Two types of interventions (20 subjects in each group) will be tested: 1)~     Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes~     walking courses aimed at provoking freezing episodes. The experimenter will trigger an~     auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g.,~     turning) and the subject will learn to synchronize his/her gait with the auditory cues,~     i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar~     principles will apply for the CLG training; however, the RAS will be elicited automatically~     by a device that recognizes an approaching freezing episode.~      Relevance to Diagnosis/Treatment of Parkinson's Disease:~      If even partially successful, the investigators will show, for the first time that freezing~     of gait is amenable to motor learning and that appropriate training with external cueing can~     alleviate these motor blockades. While future studies will be needed to further assess~     long-term efficacy and other important questions about clinical efficacy and the mechanisms~     involved, this study should go a long way towards improving the investigators understanding~     of freezing of gait and its amenability to appropriate therapy.~      Anticipated Outcome:~      The investigators anticipate that after intensive training, the central nervous system (CNS)~     of subjects with PD will be able to anticipate impending freezing episodes based on~     awareness of the environmental conditions (e.g., an approaching turn) and/or based on~     sub-conscious response to a deteriorating gait pattern. As a result, an automated motor~     response that paces and coordinates gait will be internally triggered by the CNS and the~     approaching freezing episode will be averted. The overall freezing burden will therefore~     decrease in trained subjects.~   "
139902|NCT01223599|"~     To evaluate and compare between excision with primary closure of wound and excision with~     Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of~     operation, healing time, hospital stay, complications and recurrence rate.~   "
139889|NCT01223768|"~     To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy~     (grade 3 of the West Haven grading scale), we performed a randomised, double blind~     placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on~     ammonia levels and performance in cognitive functions.~   "
139890|NCT01223755|"~     The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney~     Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of~     sirolimus (SRL) in slowing renal function decline as compared to conventional therapy.~   "
139891|NCT01223742|"~     The aim of this study was to evaluate the effect of exogenous ALC on the both physical and~     mental fatigue in mild and moderate encephalopatic patients.~   "
139892|NCT01223729|"~     Minimal hepatic encephalopathy represents a common complication present in well-compensated~     cirrhotic patients that impairs patients daily functioning and health-related quality of~     life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and~     cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study~     evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and~     on depression in patients with minimal hepatic encephalopathy.~   "
139893|NCT01223716|"~     Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of~     vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This~     study uses psychophysical measures to study neural plasticity in adults with amblyopia.~   "
139894|NCT01223703|"~     The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular~     systolic function in patients with stable chronic HF secondary to nonischemic dilated~     cardiomyopathy (NICM).~   "
139895|NCT01223690|"~     The herein protocol is based on the results of one former clinical trial conducted by our~     study group showing the considerable efficacy of intravenously administered clarithromycin~     as an adjuvant to antimicrobial chemotherapy for patients with sepsis, septic shock and~     respiratory failure in the field of ventilator-associated pneumonia. The proposed clinical~     trial is based on the need to generalize the application of intravenous clarithromycin in~     the total of admitted septic patients irrespective of the underlying cause of sepsis.~   "
139896|NCT01223677|"~     Depression and anxiety disorders are highly prevalent and associated with reduced quality of~     life for patients and enormous economic costs for society. Although effective treatments are~     available, a substantial number of patients fail to respond, and the time between disorder~     onset and treatment is typically long. The development of prevention programs therefore~     appears promising. The current project aims to prevent depression and anxiety by targeting~     excessive levels of worry and rumination, two important risk factors for emotional~     disorders. Participants will be selected on the basis of a high score on two validated~     questionnaires on worry and rumination. They will be randomly assigned to a~     rumination-focused cognitive-behavioral training delivered in a group format, a~     rumination-focused cognitive-behavioral training delivered via internet, or a no-training~     control condition. It is expected that both versions of the rumination-focused training will~     reduce symptoms of depression and anxiety, will reduce the incidence of major depressive~     episodes and generalized anxiety disorder, and will reduce symptom levels of other emotional~     disorders.~   "
139897|NCT01223664|"~     The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow~     stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the~     efficacy includes the level of serum alanine aminotransferase (ALT), aspartate~     aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB),~     prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver~     histological improvement before and 1 week to 1 year after transplantation. Child-Pugh~     scores and clinical symptoms were also observed simultaneously.~   "
139898|NCT01223651|"~     10 healthy volunteers will undergo the controlled lowering of their blood glucose level at~     sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous~     glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea~     level.~   "
139899|NCT01223638|"~     Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like~     speech delay, motor delay and lower IQ were reported in children with CH. Evidence from~     animal experiments indicate that CH is associated with high frequency of deafness.~     Morphological changes of the external and internal cholera hairs were reported in mutagenic~     mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported~     in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of~     iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and~     deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The~     expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice~     indicates that the thyroid hormones have an important role in the development of the~     internal ear.~      The etiology of deafness in human is both genetic and environmental. The prevalence of~     deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations~     are the most common cause of inherited deafness and account for about 40% of the genetic~     cases. In two conditions in human the coexistence of hypothyroidism and deafness were~     reported; Pendred syndrome and thyroid hormone resistance syndrome.~      The prevalence of hearing loss in human with CH was explored in only few studies and the~     results are contrary.~      The aim of the current study is to study the prevalence of hearing loss among children with~     CH and to compare the clinical, biochemical and genetic characteristics between subjects~     with hearing loss to those without hearing loss.~   "
139900|NCT01223625|"~     The aim of this study was to measure the effect of moderate and intensive lipid-lowering~     treatment with rosuvastatin on the endothelial function.~   "
139901|NCT01223612|"~     This exploratory study will compare the effects of ranibizumab treatment with conventional~     macular laser therapy for patients with diabetic macular oedema.~      The study hypothesises that treatment with ranibizumab may be superior to laser treatment in~     terms of improving vision and decreasing retinal thickness.~      Patients will be randomised to receive either repeated injections of ranibizumab every 4~     weeks for 48 weeks or macular laser therapy every 12 weeks for 48 weeks.~      At baseline, and then at 12, 24 and 48 weeks, patients will undergo detailed testing to~     provide information on the structure and function of the retina with both of these~     treatments.~   "
139903|NCT01223586|"~     The objective of this study is to verify the relationship between coronary plaque regression~     and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin~     and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study [NCT00242944]. In addition,~     the effect of serum lipid levels or different type of statins on cardiovascular prevention~     will also be examined.~   "
139904|NCT01223573|"~     Apgar score is a subjective measure to assess prognosis and future outcome of a newborn.~     Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective~     times in an goal to assess the usability of pulse oximetry as an added tool in determining~     the newborn prognosis~   "
139905|NCT01223560|"~     The aim of this clinical study was to obtain type 1 diabetes data to identify models for~     glucose prediction and control and to construct a physiological~     pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.~   "
139906|NCT01223547|"~     The investigators hypothesize that non-optimally treated carbohydrate counting-naïve~     patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates~     and that the metabolic control can be further improved with concurrent use of an integrated~     glucose meter and bolus calculator. The investigators want to test the hypothesis in this~     study.~   "
139907|NCT01223534|"~     Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB~     Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study~     will allow avoiding unnecessary preventive treatment without increasing rates of~     tuberculosis cases among contacts screened.~      Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone~     for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing~     study.~      Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.~      Study population: 870 subjects, household contacts of patients with culture positive~     pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A~     (standard practice), in which treatment decisions will be based on the TST result, and Arm B~     (experimental), in which treatment decisions will be based on the QFT result.~      Interventions: participants in arm A will undergo TST; participants in arm B will undergo~     TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm~     A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be~     treated with isoniazid for 6 months. All participants will be followed for two years.~      End-points of evaluation: development of tuberculosis and proportion of subjects for whom~     treatment is prescribed in each arm.~   "
139908|NCT01223521|"~     A randomized prospective study on the effects of immediate provision of intrauterine~     contraception after first trimester induced abortion - effects on repeat abortions and~     quality of life.~   "
139909|NCT01223482|"~     Studies have shown that a majority of pregnancies that end in miscarriage are due to a~     chromosome abnormality usually involving a duplicated or missing chromosome. Often this~     happens by chance and is not likely to occur in future pregnancies. For many women, a~     miscarriage can be a traumatic experience and can cause feelings of loss and grief. The~     option of genetic testing, such as karyotyping, may offer an explanation for the miscarriage~     and may help some women find closure in their loss. However, no literature exists on a~     women's experience with genetic testing following a miscarriage. This assumption that the~     knowledge that can be gained from karyotyping may be a positive experience for a woman~     following a miscarriage should be studied and the results published. This study will address~     whether routine karyotyping should be offered following a miscarriage for the purpose of~     benefiting the patient's experience.~   "
139910|NCT01223469|"~     The main objective of this study is to demonstrate the clinical safety of a contact force~     sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and~     atrial fibrillation. In addition, the study will characterize the use and value of contact~     force measurement during ablation, and the long term success (12 months) of the ablation~     procedure using this technology.~   "
139911|NCT01223456|"~     This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA~     under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2~     and are prescribed ONGLYZA by their physician.~   "
139912|NCT01223443|"~     Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac~     events (death, myocardial infarction, target vessel revascularization) over the duration of~     follow-up.~      Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with~     paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac~     death, myocardial infarction or repeat revascularization related to the target SVG over the~     duration of follow-up (minimun of 2-year follow-up.~   "
139913|NCT01223430|"~     The purpose of this study is to determine whether simultaneously using the traditional~     Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.~   "
139914|NCT01223404|"~     Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and~     schizophrenia, display abnormal regulation of the so-called default network of resting brain~     function that maintains internally directed thought when the mind is free to wander. These~     regions can be overactive or less readily deactivated with attention-demanding tasks, and~     excess activity is thought to impair performance. There is indication that nicotine may~     improve attention by aiding the deactivation of the default network, and this mechanism may~     be of therapeutic benefit for the above disease states. The current project aims at~     providing a proof of concept by demonstrating that nicotinic drugs modulate default network~     function. The nicotinic agonist nicotine is hypothesized to improve attention by~     facilitating the down-regulation of default network activity, and the nicotinic antagonist~     mecamylamine is hypothesized to impair attention by impeding the down-regulation of default~     network activity during attentional task performance.~   "
139915|NCT01223391|"~     The purpose of this study is to assess if abdominal binders that use pull strings to adjust~     compression (non-elastic) are more effective than standard elastic abdominal binders in~     attenuating neurogenic orthostatic hypotension.~   "
139916|NCT01223378|"~     The objective of this clinical investigation is to determine the most effective drug~     concentration(s) of BOL-303259-X in the reduction of IOP in order to support further~     clinical development of an appropriate dose with regard to efficacy, and ocular and systemic~     safety.~   "
139917|NCT01223365|"~     The primary objective of this study is to evaluate the safety of hydrocodone~     extended-release tablets when used over a 12-month period in patients with chronic pain, as~     assessed by adverse events, clinical laboratory results, vital signs measurements,~     electrocardiogram results, physical examination findings, pure tone audiometry, and~     concomitant medication usage.~   "
139918|NCT01223352|"~     The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two~     dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial~     hypertension (PAH) <12 years of age.~   "
139919|NCT01223339|"~     This study is to characterize the pharmacokinetics, safety, tolerability, and~     pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729,~     MK-8835) in Japanese healthy participants. The secondary objective is to investigate the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of~     ertugliflozin in Western healthy participants as compared to Japanese healthy participants.~   "
139920|NCT01223326|"~     Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver~     resection performed under ischemic preconditioning and intermittent portal triad clamping.~   "
139921|NCT01223313|"~     WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational~     (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female~     condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that~     will be used in this study is not lubricated, but a water-based lubricant will be provided~     for you to use with it. Also, the female condoms used in this study will be provided to you~     at no cost.~      WHY IS THIS STUDY BEING DONE?~      The purpose of this study is to find out:~        -  How well the female condom works to prevent pregnancy~        -  How well the female condom works to prevent transmission of sexually transmitted~          diseases~        -  How safe the female condom is to use~        -  If urinary tract infections and symptomatic vaginal infections occur while using the~          female condom~        -  How well women like the female condom~        -  How well the female condom performs.~      WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about~     500 women from all over the United States participating in this study. You are being asked~     to participate in a research study because you are a woman between the ages of 18 and 40,~     are in general good health, have regular menstrual cycles, do not want to become pregnant~     for at least the next 7 months, and are willing to rely on the female condom as your primary~     method of contraception during study participation.~      HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months.~     You will need to come to the clinic for a screening/admission visit and then 2 or more~     visits. You will also be asked to complete a diary every day about your use of the female~     condoms. The clinical staff will help set up your planned clinical visits during the study.~   "
139922|NCT01223300|"~     The aim of this research registry is to collect information on individuals with~     osteoporosis, those with risk factors for osteoporosis, and comparative healthy controls.~     Bone mineral density measurements will be done on these individuals to determine bone~     health.~   "
139923|NCT01223287|"~     This observational study was conducted to design and test a physiologic definition for~     bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position~     with the pulse oximeter in position with good signal prior to collecting baseline data.~     Feedings and medications were given 30 minutes before the evaluation. Baseline data was~     collected on infant's current oxygen. Then, the infants were weaned to room air for 30~     minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen~     reduction challenge (to NOT have BPD). The infant should then be placed back in his/her~     baseline oxygen. If the infant has saturations <90% for 5 continuous minutes or <80% for 15~     seconds, the infant should be immediately placed back in his/her baseline oxygen, and the~     infant was considered to have NOT passed the challenge (to have BPD).~   "
139924|NCT01223274|"~     This pilot study was designed to determine the feasibility of randomizing extremely low~     birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two~     resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway~     pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure~     (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP~     and no PEEP if the infant required PPV (the control group).~   "
139925|NCT01223261|"~     The purposes of this study were: 1) to compare mortality and postoperative morbidities in~     extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for~     necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the~     ability to distinguish NEC from IP preoperatively and the importance of this distinction on~     outcome measures; and 3) to evaluate the association between extent of intestinal disease~     determined at operation and outcome measures. All ELBW infants born at participating NRN~     centers were screened for the presence of NEC or IP that was thought by the pediatric~     surgeon and neonatologist to require surgical intervention. Data were collected enrolled~     infants, including: intraoperative findings recorded by the surgeon and specific~     post-operative complications. Neurodevelopmental examinations were conducted on surviving~     infants at 18-22 months corrected age.~   "
139946|NCT01222988|"~     Obtain a preliminary assessment of the feasibility and acceptability of delivering the~     sustained lost weight (SLW) intervention in a real-world clinical setting for patients who~     have completed a 21-week very low calorie diet (VLCD).~      Hypothesis: Intervention will be feasible to implement as evidenced by the ability to~     recruit and retain participants and acceptable to participants as evidenced by self-report~     of satisfaction with the program and adoption of weight maintenance behaviors.~      Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost~     weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie~     diet (VLCD).~      Hypothesis: Greater than 75% of participants who receive this novel approach, where~     maintenance behaviors are individualized based on resting metabolic rate and a physical~     activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.~   "
139947|NCT01222975|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     Risperidone formulations after administration of single doses to normal, healthy subjects~     under fasted conditions.~   "
139948|NCT01222962|"~     The study was designed to assess the effect of food on the extent and rate of absorption of~     Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose~     combination (Eurartesim™).~   "
139926|NCT01223248|"~     The purpose of this study is to find out which way of giving high-dose radiation works best~     for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes.~     This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3~     days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy~     (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the~     exposure to normal tissue. Currently there are no studies that compare the effects of giving~     radiation in either hypofractionated doses (higher total doses of radiation spread out over~     several treatment days) or a single-fraction dose (entire radiation dose given in one~     treatment session).~      The patient may be asked to participate in an additional part of this study where we will~     get a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment.~     If the patient is asked to take part in this portion of the study, all they will need to do~     is get up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a~     result of the treatment there are changes in the blood flow going to the cancer which could~     suggest that the treatment may be successful.~      In addition some patients can present new lesions and may be asked if they would like to~     have these new lesions treated on the protocol. If they are given this option, this will not~     extend their follow up period. The follow up of the new lesions will match with the prior~     follow up dates.~   "
139927|NCT01223235|"~     The immune system of the body has the ability to fight and eliminate infections and cancers.~     Immune treatments, such as in this study, seek to teach the immune system to find and~     destroy cancer cells. The purpose of this study is to test whether it is safe to treat the~     cancer with a vaccine and another drug called bevacizumab (also known as Avastin).~   "
139928|NCT01223222|"~     The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied~     topically to uncomplicated skin infections.~      Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.~   "
139929|NCT01223209|"~     This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001).~     This will be tested in patients that have had surgery with curative intent for malignant~     tumour.~      GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to~     start the immune response in the body to have effect of GV-1001.~      LTX-315, also a peptide, in development for cancer treatment. In this study, the~     investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating~     the immune system.~   "
139930|NCT01223196|"~     Background: Pioglitazone has been shown to have potent anti-inflammatory as well~     anti-atherosclerotic effects. However, the mechanisms by which pioglitazone exerts these~     effects are not clear. The investigators propose that Tissue Inhibitor of~     MetalloProteinase-3 (TIMP-3) and TNF-alfa converting enzyme (TACE) play a major role in~     pioglitazone mediated improvement in insulin sensitivity and endothelial function. In animal~     models, low dose pioglitazone inhibits lesion progression and matrix metalloproteinase~     expression in advanced atherosclerotic plaques. The investigators believe that a lower dose~     of Pioglitazone will also have anti-inflammatory effects.~      Aim: To examine the effect of low dose Pioglitazone (15mg/day) on TIMP and TACE in~     Pioglitazone mediated improvements in insulin sensitivity.~      Methods: Thirty subjects with T2DM will participate in following studies: (i) oral glucose~     tolerance test (OGTT); (ii) Dual energy absorptiometry(DXA) for body fat content, (iv)~     skeletal muscle biopsy. Subjects will be randomized to receive either placebo or~     pioglitazone for 24 weeks. The investigators will study the effect of Pioglitazone on (1)~     TIMP and TACE substrate activity in skeletal muscle, adipose tissue, mononuclear cells, and~     their relationship to insulin sensitivity and vascular reactivity, other adipocytokines-~     resistin, TNF-α and Visfatin; (2) markers of inflammation and atherosclerosis- C-reactive~     protein, VCAM-1 (vascular cell adhesion molecule 1), ICAM-1 (Intercellular Adhesion Molecule~     1), endothelin 1, E-selectin, P-selectin, TNFrecI (Tumor Necrosis Factor Receptor I),~     TNFrecII (Tumor Necrosis Factor Receptor II), IL-6 (Interleukin 6) receptor.~   "
139931|NCT01223183|"~     Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung~     problems for people with cystic fibrosis (CF). Many researchers now believe that people with~     CF absorb too much water from the insides of their lungs, and that the mucus in their lungs~     becomes so thick and sticky because there is not enough water in it. The investigators are~     trying to develop ways to measure how fast water is absorbed from the breathing tubes in the~     lung so that the investigators can more quickly test new medications that are being~     developed to fix this problem for CF patients. The investigators have already done studies~     showing that people with CF absorb a particular radioactive drug (Indium-111 DTPA or~     In-DTPA) from their lungs more quickly than people without CF. Now the investigators are~     trying to prove that the absorption of this drug is related to the absorption of water. The~     investigators measure the absorption of In-DTPA by delivering it in an aerosol (inhaled~     mist) along with another radioactive drug (Technetium 99m sulfur colloid). This other drug~     helps us measure how much material is cleared from the lungs in other ways (like coughing)~     without being absorbed. In this study, the investigators will measure how the absorption of~     In-DTPA is affected by inhaling isotonic saline and hypertonic saline (salt water), both of~     which the investigators know affect the absorption of water in the airways.~   "
139949|NCT01222949|"~     The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers~     and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the~     relative bioavailability of DHA and PQ.~   "
139962|NCT01222780|"~     Background:~        -  Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine~          sulfate, which is a widely used anticancer drug, and packages it into a tiny fat bubble~          known as a liposome. The goal of this is to improve the drug's ability to destroy~          cancer cells and help reduce the potential side effects of treatment.~        -  Vincristine sulfate was originally developed from chemicals found in the periwinkle~          plant and acts against multiple types of malignant cancer. It is approved for multiple~          cancer types including solid tumors and blood cancers.~        -  Research has shown that Marqibo(Registered Trademark) is able to slow or stop the~          growth of cancer cells in some adults, both alone and in combination with other~          chemotherapy drugs, but more research is needed to determine its use in children.~        -  There has been one previous small study of Marqibo(Registered Trademark) in children.~          Although some anti-cancer activity was seen, side effects and optimal dosing were not~          fully determined.~        -  As is seen with standard Vincristine suflate, the most common side effect of~          Marqibo(Registered Trademark) involves the nervous system. It can cause numbness and~          tingling in the hands and feet. Symptoms commonly improve when the drug is discontinued~          or the dose is lowered.~      Objectives:~      - To determine the safety and efficacy of Marqibo as a treatment for children who have been~     diagnosed with certain types of malignant cancer that has not responded to standard~     treatment.~      Eligibility:~        -  Children and adolescents between 2 and 21 years of age who have been diagnosed with~          certain types of malignant cancer that has not responded to standard treatment.~        -  These cancer types include solids tumors, primary brain tumors, leukemias, and~          lymphomas....~   "
139932|NCT01223170|"~     Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading~     causes of death and represent 30% of all global deaths and 48% of the deaths in Europe.~     Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases~     over the next years. Secondary preventive efforts can decrease mortality risk as well as~     improve health among Cardiovascular Disease patients.~      This study suggests an innovative approach in supporting the self-management of~     Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled~     Trial has two arms and aims to investigate the effectiveness of tailoring in an Information~     and Communication Technology (ICT) based intervention. The tailoring will be based on~     concepts derived from health psychology theories, and will contribute in their further~     development. More specifically:~        -  Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met~          through the use of ICT.~        -  Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance~          of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention~          group (tailored) will have higher adherence a) to the Internet-based intervention, and~          b) to self-management.~        -  Aim 3: To assess the effect of mobile technology with activity sensors on physical~          activity. Hypothesis: There will be a relationship between the data collected from~          activity sensors and the self-reported physical activity levels.~   "
139933|NCT01223157|"~     Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive~     procedures. The investigators managed in the lab to determine the levels of endocannabinoids~     in a small number of subjects. The aim of the study is to confirm that salivary is a useful~     tool to evaluate the activity of the ECS both in normal weight and obese subjects that are~     characterised by a hyperactivity of the system. Therefore, the first objective of the study~     is to compare the fasting level of salivary anandamide between 12 obese patients and 12~     normal weight subjects.~   "
139934|NCT01223144|"~     The present study aims at investigating cognitive functions requiring orbitofrontal control,~     namely decision-making and facial emotion recognition. The investigators hypothesize that~     decision-making and facial emotion recognition are impaired in patients with essential~     tremor (ET) due to frontal lobe dysfunction which may have consequences in daily social~     life.~   "
139935|NCT01223131|"~     Primary Objective:~      6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated~     hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes~     mellitus (T1DM) aged at least 6 years to less than 18 years.~      Secondary Objectives:~        -  To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:~             -  Percentage of patients reaching International Society of Pediatric and Adolescent~               Diabetes (ISPAD) recommended target of HbA1c < 7.5%,~             -  Fasting blood glucose (FBG),~             -  Nocturnal blood glucose (BG),~             -  24-hour blood glucose profile based on 8-point self-monitoring of blood glucose~               (SMBG) values,~             -  Daily total insulin dose and basal insulin dose,~             -  Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal~               symptomatic hypoglycemia.~        -  To assess the safety and tolerability of insulin glargine versus NPH insulin based on~          the occurrence of treatment-emergent adverse events (TEAEs).~        -  To assess anti-insulin and anti-glargine antibody development in both groups.~        -  To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin~          glargine in selected sites with approximately 45% of insulin glargine population to~          rule out accumulation tendency of insulin glargine after repeated dosing~   "
139936|NCT01223118|"~     The purpose of this study is to determine the rate of cryosurvival of mature oocytes~     following vitrification, and to then compare the reproductive potential of vitrified oocytes~     relative to those which have not been cryopreserved.~   "
139937|NCT01223105|"~     This study seeks to evaluate whether the vitrification technique, as compared to the more~     traditional slow-cooling technique, leads to higher rates of successful thawing,~     fertilization, implantation and delivery.~   "
139938|NCT01223092|"~     The purpose of this this study is to use DNA screening strategies to identify genes and~     localize genomic regions that are differentially expressed in patients with infertility to~     further understand the genetic basis for reproductive competence.~   "
139939|NCT01223079|"~     The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the~     late follicular phase of young women undergoing controlled ovarian stimulation for oocyte~     donation.~   "
139940|NCT01223066|"~     The study objective is to evaluate the long term safety when Macrolane Volume Restoration~     Factor is used in female breasts in clinical practice.~   "
139941|NCT01223053|"~     Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10%~     ketoprofen for the local treatment of pain associated with mild to moderate acute soft~     tissue injury in this confirmatory Phase 3 trial.~   "
139942|NCT01223040|"~     The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane~     Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye~     patients.~   "
139943|NCT01223027|"~     This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients~     with metastatic renal cell cancer.~   "
139944|NCT01223014|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of~     [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this~     study is to investigate how and how quickly AZD 2423 or its break down products are excreted~     by analysing blood, faeces and urine samples collected during the study.~   "
139945|NCT01223001|"~     The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth~     daily with placebo in the prevention of depression associated with mild/moderate traumatic~     brain injury and to enhance cognitive function.~   "
139963|NCT01222767|"~     This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis®~     (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of~     Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the~     antitumor activity of Zalypsis.~   "
140333|NCT01217944|"~     This study is designed to evaluate the efficacy and safety of two different dosing regimens~     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in~     patients with visual impairment due to choroidal neovascularization (CNV) secondary to~     pathologic myopia (PM).~   "
139950|NCT01222936|"~     SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to~     cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour~     relapse and a very poor life expectancy. Combination chemotherapy based on cisplatin or~     carboplatin and etoposide represents the most widely used regimen. Despite of the high~     response rate, approximately 80% of patients with limited disease and nearly all patients~     with extended disease develop disease relapse or progression. Topotecan is, at present, the~     only approved second line treatment in Europe.~      The search of a new therapeutic agent that could alter the natural history of SCLC would be~     an important goal to be reached. LBH589 (Panobinostat) is a histone deacetylase (HDAC)~     inhibitor available for intravenous and oral administration. LBH589 could be classified as~     PAN-DAC inhibitor targeting both histone and non histone proteins and as such it could be~     suitable for combination with cytotoxics. Three phase I dose escalation studies with both~     the intravenous and the oral formulation of LBH589, examining various dose schedules of~     administration have been conducted in advanced solid tumours and haematological~     malignancies.~      Single agent activity was observed in phase I in patients with haematological cancer. In~     solid tumours one response (Hormone-refractory Prostatic Cancer) and some prolonged~     stabilizations have been observed with intravenous formulation. Phase II studies are now in~     progress.~   "
139951|NCT01222923|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     Risperidone formulations after administration of single doses to normal, healthy subjects~     under fed conditions.~   "
139952|NCT01222910|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir~     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®~     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,~     adult, male, human subjects under fasting condition.~   "
139953|NCT01222897|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir~     hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®~     caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,~     adult, male, human subjects under fed condition.~   "
139954|NCT01222884|"~     The purpose of this study is to compare the efficacy and safety of intravenous iron~     isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic~     Kidney Disease on Dialysis Therapy (CKD-5D).~   "
139955|NCT01222871|"~     The purpose of this study is to compare the effectiveness of intranasal Triamcinolone~     delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked~     dressing, in the treatment and prevention of early nasal polyposis.~   "
139956|NCT01222858|"~     The proposed project addresses the significant problem of obesity and uses innovative~     technology to improve adherence to a behavioral weight loss strategies. If the program is~     effective, it would provide an outstanding resource for physicians to use with their~     patients and thus would have tremendous clinical impact.~   "
139957|NCT01222845|"~     The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite~     responses to porridge made with oats processed differently.~   "
139958|NCT01222832|"~     This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS~     a sponge soaked in Saline / and the administration of oral antibiotics.~   "
139959|NCT01222819|"~     Granulocyte colony stimulating factor (G-CSF) is frequently used among patients with cancer~     including those with haematological malignancies.~      Filgrastim is a recombinant human CSF whose biological activity is similar to that of~     endogenous G-CSF.~      In the treatment of chemotherapy-induced neutropenia in patients with various types of~     cancer CSFs significantly reduced the time to neutrophil recovery and length of~     hospitalization.~   "
139960|NCT01222806|"~     Background:~      - Cocaine addiction is often difficult to treat, particularly because exposure to others~     using cocaine or to pictures of cocaine may evoke cocaine craving and lead a person to~     resume cocaine use after having quit. Breaking this link with cocaine craving might improve~     treatment for cocaine addiction. Research suggests that repetitive pulses of transcranial~     magnetic stimulation (rTMS) applied to the skull can change nerve cell firing in the brain.~     rTMS was recently approved as a treatment for depression, and is being studied as a way to~     reduce drug craving. However, because only a few small studies have looked at the effects of~     rTMS on cocaine craving, more research is needed on whether it is effective in reducing~     cocaine craving and use in individuals who currently use cocaine on a regular basis.~      Objectives:~      - To determine whether transcranial magnetic stimulation can lower craving for cocaine when~     given in connection with cocaine-related images.~      Eligibility:~      - Individuals at least 18 years of age who have used cocaine for at least 2 years and~     currently using at least 3 times per week.~      Design:~        -  This study involves an initial screening visit, two brain imaging sessions, five rTMS~          sessions, and two follow-up visits.~        -  Participants will be screened with a medical history, physical examination, urine~          samples, questions about drug use history and previous efforts to quit, and tests for~          breath alcohol and nicotine levels.~        -  Participants will have two magnetic resonance imaging (MRI) scan sessions: one baseline~          scanning session before starting their rTMS sessions and a second scanning session~          after their last rTMS session . Part of each scanning session involves functional MRI~          (fMRI) scans. During the fMRI scans, participants will look at pictures related to~          cocaine use and pictures that are not related to cocaine use. Participants will also~          perform a simple decision task during the scans.~        -  Participants will have five rTMS sessions, one per day for 5 days in a row. Each~          session will last 1 to 2 hours. Participants will have either real or sham (simulated)~          rTMS while looking at pictures that may or may not be related to cocaine use, and will~          also perform a simple decision task that is the same as the one given during the MRI~          scans. The decision as to whether participants get real or sham rTMS will be made by~          chance. Neither the participants nor the investigators will know which type the~          participants are getting. - Participants will have two follow-up visits one and two~          weeks after their last rTMS session. At each visit they will be checked for cocaine and~          other substance use and for possible side-effects from rTMS.~   "
139961|NCT01222793|"~     Background:~      - Although second-generation antipsychotic medications have fewer serious side effects and~     complications than first-generation ones, they are strongly associated with weight gain for~     reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics~     with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may~     provide more information on which medications are best suited for different individuals.~     Researchers are interested in studying how people taking various antipsychotics compare with~     controls in regard to food craving and eating behavior. This knowledge should help to guide~     practitioners when advising patients about the weight-gain effects of these medications.~      Objectives:~      - To examine eating behavior and food craving in patients with schizophrenia who are taking~     HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls~     taking no antipsychotics.~      Eligibility:~        -  Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia~          or a related disorder, have a body mass index between 25 and 29.9, and have never had~          an eating disorder.~        -  Healthy individuals between 18 and 45 years of age who have a body mass index between~          25 and 29.9 and have never had an eating disorder.~      Design:~        -  This study involves an initial screening visit and four study visits.~        -  Participants will be screened with a medical history and physical examination, as well~          as questionnaires about stress levels, food cravings, smoking, exercise, and eating~          habits; a taste test; and saliva collection (to measure stress hormones).~        -  Visit 2: Participants will have an optional overnight stay, and will provide blood~          samples before having a breakfast beverage and answering questions about tiredness,~          anxiety, hunger, and alertness during a 1.5 hour session.~      Visit 3: Participants will have an optional overnight stay and a light breakfast, followed~     by blood draws and questions about hunger and food cravings.~      Visit 4: Participants will have an optional overnight stay, followed by questions about food~     preference. Participants will not be allowed to eat until mid-morning of the next day.~      Visit 5: Participants will eat normally before arriving at the research site, and will have~     tests to measure food craving and questionnaires about mood and feelings.~   "
139964|NCT01222754|"~     Background:~      - Children who are diagnosed with brain tumors known as high grade gliomas or diffuse~     intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy.~     However, these tumors are very difficult to cure, and the tumor frequently begins to grow~     again even after treatment or surgery. Researchers are interested in determining whether the~     anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer,~     is a safe and effective additional treatment for children who are scheduled to receive~     radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.~      Objectives:~      - To determine the safety and effectiveness of lenalidomide, in conjunction with radiation~     therapy, as a treatment for children who have been diagnosed with high grade gliomas or~     diffuse intrinsic pontine gliomas.~      Eligibility:~      - Children and adolescents up to 21 years of age who have been diagnosed with high grade~     gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.~      Design:~        -  Participants will be screened with a medical history, physical examination, blood and~          urine tests, and imaging studies.~        -  Participants will have two phases of treatment: a lenalidomide plus radiation phase and~          a lenalidomide-only phase.~        -  During the radiation phase, participants will take lenalidomide daily and have 6 weeks~          of radiation therapy (five treatments per week). After the radiation therapy,~          participants will stop taking lenalidomide for 2 weeks before continuing to the next~          phase.~        -  During the lenalidomide-only phase, participants will take lenalidomide daily for 21~          days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants~          will have up to 24 cycles of lenalidomide.~        -  Participants will have frequent blood tests during the first cycle of treatment, and~          will have imaging studies or other tests as required by the study researchers.~        -  Treatment will continue until the disease progresses, the participant chooses to leave~          the study, or the researchers end the study....~   "
139965|NCT01222741|"~     Background:~      - Researchers are interested in studying disorders that make individuals more susceptible to~     fungal infections, specifically infections with the Candida yeast. These disorders are often~     related to problems with the immune system and may have genetic factors, which suggests that~     researchers should study not only the individual with the disorder, but also his or her~     first- and second-degree relatives (such as parents, siblings, children, and first cousins).~     To provide material for future research, individuals with immune disorders and their first-~     and second-degree relatives will be asked to provide blood and other samples for testing and~     comparison with samples taken from healthy volunteers with no history of immune disorders.~      Objectives:~      - To collect blood and other biological samples to study immune disorders that make~     individuals more susceptible to fungal infections.~      Eligibility:~        -  Individuals of any age who have abnormal immune function characterized by recurrent or~          unusual fungal infections, recurrent or chronic inflammation, or other types of immune~          dysfunction.~        -  First- or second-degree genetically related family members (limited to mother, father,~          siblings, grandparents, children, aunts, uncles, and first cousins).~        -  Healthy volunteers at least 18 years of age (for comparison purposes).~      Design:~        -  Participants will provide blood samples and buccal (cells from the inside of the mouth~          near the cheek) samples.~        -  Participants with immune disorders will also be asked to provide urine samples, saliva~          or mucosal samples, or skin tissue biopsies, and may also have imaging studies (such as~          x-rays) to collect information for research.~        -  Samples may be collected at the National Institutes of Health or at other clinical~          locations for the samples to the sent to the National Institutes of Health.~        -  No treatment will be provided as part of this protocol.~   "
139966|NCT01222728|"~     Background:~        -  Neurofibromatosis type II (NF2) is associated with tumors of the nerves, brain, and~          spinal cord. Most people with NF2 develop vestibular schwannomas, or tumors on the~          hearing and balance nerves. As they grow, vestibular schwannomas can cause hearing loss~          and balance problems. If they grow very large they can cause more serious problems,~          such as seizures, loss of eyesight, weakness, speech problems, and problems with the~          sense of touch. More research is needed into NF2 because researchers do not completely~          understand why these tumors occur or what makes them grow over time.~        -  Currently, tumor size is measured with magnetic resonance imaging (MRI) scans. However,~          MRI scans cannot predict how fast a tumor will grow. By using positron emission~          tomography (PET) scanning, researchers hope to be able to predict sudden growth spurts~          of tumors associated with NF2 and develop better treatment methods for this type of~          cancer.~      Objectives:~      - To use magnetic resonance imaging and positron emission tomography to better understand~     the growth of brain tumors in people with neurofibromatosis type II.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at~     least three untreated intracranial tumors.~      Design:~        -  This study requires an initial set of outpatient visits to the NIH Clinical Center that~          will last 7 to 10 days.~        -  Participants will have a physical and neurological examination and blood tests at the~          first visit. Participants will then have the following imaging studies to examine the~          tumors:~        -  MRI scans of the brain~        -  PET scans of the brain, combined with a computed tomography (CT) scan. The PET scans~          will be performed on separate days. Different contrast agents will be used for both~          scans, so researchers will inform participants if they need to fast or follow other~          procedures before having the scan.~        -  After the initial imaging studies, participants will have additional MRI scans every 6~          months for 2 years to track tumor growth.~   "
139967|NCT01222715|"~     This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide~     work in combination with bevacizumab or temsirolimus in treating patients with recurrent or~     refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking~     blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is~     more effective when given together with bevacizumab or temsirolimus in treating~     rhabdomyosarcoma.~   "
139968|NCT01222702|"~     Subjects with Clostridium Difficile Infection (CDI) are randomized and then treated with~     study drug for 10 days.~      At the end of treatment, cure is assessed; subjects are then followed-up to assess any~     disease recurrence.~   "
139969|NCT01222689|"~     This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together~     works in treating patients with locally advanced or metastatic pancreatic cancer that is~     refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
139970|NCT01222676|"~     RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.~     Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill~     more tumor cells. Giving them before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~      PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine~     hydrochloride together with sorafenib tosylate works in treating patients with node-negative~     transitional cell cancer of the bladder.~   "
139971|NCT01222663|"~     The purpose of this randomized, comparative, open and multi-centre study is to show that two~     sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the~     surgery of a peritonitis by hollow organ perforation reduce the mortality in patients~     suffering from septic shock.~   "
139972|NCT01222650|"~     The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to~     placebo for the treatment of LUTS caused by BPH.~   "
139973|NCT01222637|"~     This is a prospective, open label, multicenter study evaluating the safety, tolerability and~     pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR~     positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the~     development of anti-drug antibodies and on tumour response will also be evaluated.~   "
140336|NCT01217905|"~     This is a study in Japanese healthy volunteers to determine the safety and tolerability of~     the compound AZD7687. It will also assess how the body handles the drug and how it responds~     to the drug following single dose followed by multiple dosing over 7 days.~   "
139974|NCT01222624|"~     This is a prospective, open label, dose escalating, multicenter, phase I study measuring the~     safety, tolerability, and pharmakokinetics of PankoMab-GEX™ after intravenous administration~     in patients with locally advanced or metastatic solid cancers refractory to standard~     treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response~     will also be evaluated.~   "
139975|NCT01222611|"~     This study examines the impact of fosamprenavir as part of an ART on virological,~     immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected~     subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this~     is shown to be true, changes in HCV viral load or biological characteristics could be~     demonstrated.~   "
139976|NCT01222598|"~     This is a confirmation of safety profile for Minirin Melt in clinical practice.~   "
139977|NCT01222585|"~     Yearly in the United States over 500,000 newborns are delivered prematurely. This population~     is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants~     with necrotizing enterocolitis are at high risk of death, and survivors are at increased~     risk of mental retardation. Metronidazole is an antibiotic that is often administered to~     infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the~     appropriate dose of metronidazole in premature infants has not been established and it is~     likely to be different from older children and adults.~      The investigators will investigate the appropriate metronidazole dose in very premature~     infants by: 1) determining how premature infants eliminate metronidazole from the body and~     2) determining the safest and most effective dose of metronidazole in premature infants.~      The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with~     infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary~     drug levels to treat bacteria involved in necrotizing enterocolitis.~   "
139978|NCT01222572|"~     In this research study the investigators are looking for the highest dose of a stereotactic~     radiation boost that can be given safely. Because stereotactic radiation is so precise, the~     investigators are testing whether it can be used to increase the dose to the primary tumor~     without significantly increasing the side effects the participant experiences; the goal is~     to improve the likelihood of killing the tumor.~   "
139979|NCT01222559|"~     This is a prospective, phase III, multicenter, open label, randomised clinical trial of~     co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product~     (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage~     defects of knee joints.~      After screening visit patients were booked for arthroscopy and at that time they were~     randomised to either ACT3D-CS with co.don chondrosphere® (Group A) or to MF(Group B), a~     marrow-stimulating method based on the penetration of the subchondral bone plate at the~     bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their~     procedure of MF (treatment surgery) and patients of group A had their cells harvested from~     healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope~     3-dimensional spheroids , that are transplanted in an open knee procedure (treatment~     surgery)into the defect. Patients subsequently followed the same rehabilitation program and~     had post-surgery visits. After the 12-month-visit a interim analyses will be performed and~     the 24-month-visit is defined as final assessment. Then patients have follow-up assessments~     up to 60 months post-treatment-surgery.~   "
139980|NCT01222546|"~     This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety,~     pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients~     with advanced solid tumors.~   "
139981|NCT01222533|"~     The purpose of this study is compare the effect of different doses of tiotropium delivered~     by the HandiHaler and Respimat device on lung function. Additionally, the study will~     investigate the pharmacokinetic profile of these different doses. Studying the~     pharmacokinetic profile shows what happens to the medication in the body over a period of~     hours and provides information on potential effects of the medication.~   "
139982|NCT01222520|"~     If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an~     antihypertensive drug from different class should be started concomitantly.~      In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential~     hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg,~     the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg~     monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan~     80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or~     her blood pressure controlled with telmisartan 80 mg.~      Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and~     safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different~     pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with~     telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who~     fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg~     monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy,~     active-controlled, parallel group comparison method is employed.~   "
139983|NCT01222507|"~     The overall purpose of this research is to assess whether both the 60 second Brain Game~     and the Brain Speed Test computer-based programs can be used as assessment tools for~     objectively defining the severity of the functional impact of tinnitus.~   "
140008|NCT01222182|"~     A group of ~ 225 patients were switched from atorvastatin to an equivalent statin either by~     their physicians usual management or by an collaborative pharmacist coordinated process. We~     will compare the results of pharmacist process to the standard medical practice to find~     potentially which process is more effective, safer and efficient. We are surveying a total~     of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their~     satisfaction of the 2 processes.~   "
140009|NCT01222169|"~     To describe respiratory and laryngeal responses to laryngeal stimulation during propofol~     anesthesia in children. To determine whether the co-administration of lidocaine blunts these~     reflex responses. The outcome of primary interest is the reflex laryngospasm.~      Hypotheses:~      I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv.~     administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol~     (3mcg/ml).~      II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv.~     administration of lidocaine is equivalent to the response before the administration of~     lidocaine.~   "
139984|NCT01222494|"~     This K23 award application is relevant to multiple topic areas in the recent Institute of~     Medicine (IOM) research priority list, as well as the recent IOM report brief and White~     House Let's Move Campaign focused on childhood obesity. The US prevalence of~     childhood-onset obesity and type 2 diabetes, both predictors of cardiovascular risk, have~     increased to epidemic proportions in recent decades. Children with mental illness,~     especially those treated with antipsychotic medications, are at additional risk for obesity~     and related risk conditions. Despite known increases in obesity-related outcomes, including~     premature mortality, associated with childhood-onset versus adult-onset obesity, there~     remains an under-appreciation of these risks in children. A variety of noninvasive~     techniques to assess cardiometabolic risk have begun to be applied in children, including~     carotid intima media thickness (IMT) measured by ultrasound, and hepatic triglyceride~     content (IHTG) measured by 1H Magnetic Resonance Spectroscopy (MRS). These measures allow~     for the early, noninvasive study of metabolic risk. Unfortunately, none of these promising~     methods have been applied to the high-risk population of children with psychiatric~     disorders, and cardiac triglyceride content has not been evaluated in children at all,~     preventing accurate characterization of risk or the effectiveness of interventions the~     reduce risk in this vulnerable population. The overall aim of this two-study research plan~     is to characterize the level of measurable risk using these sensitive markers in treated and~     untreated children with mental health disorders, and to evaluate the magnitude of change in~     risk that can be observed using these biomarkers in children receiving a well established~     behavioral weight-loss intervention.~   "
139985|NCT01222481|"~     Cancer survivorship has dramatically improved within the last four decades and a greater~     number of Americans are living after cancer diagnosis. An increase in the number of~     survivors has highlighted the need to investigate the quality of life experienced by these~     survivors. While Survivorship research has improved our understanding of the challenges~     faced by some cancer survivors, there is a paucity of research on the functional and~     cognitive health status of head and neck cancer survivors.~      The purpose of this study is to evaluate the functional and cognitive changes that occur in~     head and neck cancer patients as a result of cancer treatment, in an attempt to increase our~     understanding of the complex interactions between cancer treatment, comorbid health ailments~     and quality of life.~   "
139986|NCT01222468|"~     This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on~     spasticity in spinal cord injured persons.The study will be a phase 2, randomized,~     placebo-controlled crossover study. Each eligible subject will participate for 26~     weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of~     the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over~     the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to~     the opposite arm for another 11 week treatment period (phase 2).~   "
139987|NCT01222455|"~     A study to evaluate the amount of fostamatinib in the blood in subjects with impaired~     hepatic (liver) function compared with healthy volunteers with normal liver function. The~     study will also evaluate safety and tolerability in subjects with hepatic impairment.~   "
139988|NCT01222442|"~     The purpose of this research study is to evaluate the effect of AZD3199 on the electrical~     activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic~     (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known.~     Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will~     also be assessed.~   "
139989|NCT01222429|"~     This study aims to test a dietary intervention for diabetes in a medical practice setting,~     with the aim of developing a model for diabetes care that can be used widely. The~     investigators hypothesize that a low-fat vegan diet will be effective for management of~     diabetes and will be feasible in a practice-based setting.~   "
139990|NCT01222416|"~     The purpose of this study is to develop Positron Emission Tomography (PET) - Computed~     Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast~     cancer.~   "
139991|NCT01222403|"~     This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women~     aged 65 years and older.~   "
139992|NCT01222390|"~     The purpose of this study is to explore the volume change and location of volume change in~     reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to~     investigate the safety of using CPX3® in tissue-expander breast reconstruction via a~     comparison between the complication rates that result from this study and the complication~     rates with the use of other tissue expander types, as reported in the literature. We also~     hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and~     lower breast volume change and location of this volume change in the reconstructed breast.~     Finally, we intend to provide reconstructive surgeons with a scientific study that~     quantifies the patient satisfaction with aesthetic results of CPX3 in tissue~     expander-implant breast reconstruction. We hypothesize that the CPX3 tissue expander will~     provide more lower pole volume expansion when compared to lower pole volume expansion from~     round, standard tissue expanders as reported in the literature. Additionally, we hypothesize~     that CPX3, in combination with human acellular dermis, is less prone to complications than~     standard tissue expanders (again, as reported in the literature).~   "
139993|NCT01222377|"~     RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast~     cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial~     studies endoscopic breast surgery in treating patients with breast cancer.~   "
139994|NCT01222364|"~     This study tested the feasibility of conducting a randomized controlled trial to vary the~     timing that doctors clamp the umbilical cord after birth in extremely low birthweight~     infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding~     the newborn approximately 10 inches below the birth canal would result in increased~     hematocrit at 4 hours of age.~   "
140021|NCT01222013|"~     The purpose of this study is to evaluate the efficacy, through molecular response and~     event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM~     like Induction in children with ALL Ph+.~   "
140235|NCT01219218|"~     Low intensity shockwaves have been proven in animal studies to induce local growth of new~     blood vessels from existing ones.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of~     patients with refractory angina not amenable to revascularization with angioplasty or bypass~     surgery.~   "
139995|NCT01222351|"~     The overall goal of this project is to establish and validate biomarkers associated with the~     risk and progression of late onset Alzheimer's disease, mild cognitive impairment and~     cognitive decline. The investigators will use baseline and longitudinal measurements of~     plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild~     cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive~     decline and Alzheimer's disease progression. Participants will be selected on the basis of~     change in plasma amyloid beta levels over prior assessment intervals. The purpose of the~     study is to examine whether brain amyloid plaque load, which will be measured with positron~     emission tomography and x-ray computed tomography brain imaging using Florbetaben from~     Bayer, varies as a function of change in plasma levels of amyloid beta. The driving~     hypothesis of the study is that high plasma levels of amyloid beta are an antecedent~     indicator of increased risk of cognitive decline, mild cognitive impairment, and incident~     late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are~     associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta~     are related to increased levels of amyloid beta in the brain as measured by positron~     emission tomography positivity, and the specific pattern of positron emission tomography~     positivity and a decline in plasma amyloid beta over time are associated with the onset of~     cognitive decline associated with late onset Alzheimer's disease.~   "
139996|NCT01222338|"~     Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of~     drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24~     months) and more toxic treatment course. In prior open label study the investigators have~     shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance~     by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce~     liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators~     propose to conduct placebo-controlled clinical trial in patients with treatment refractory~     TB so that the clinical benefit of V5 is confirmed.~   "
139997|NCT01222325|"~     In order to check if a reduction in the frequency and total number of shocks delivered~     during extracorporeal shockwave lithotripsy (SWL) results in a great number of stone-free~     patients,the investigators compared two different ways of treating urinary stones using SWL.~   "
139998|NCT01222312|"~     The study compares two combinations of chemotherapy in patients with advanced or metastatic~     NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with~     oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile~     is often not tolerable. Especially in elderly patients or patients with comorbidities,~     oxaliplatin based chemotherapy may have lower toxicities but comparable or even better~     response rates.~   "
139999|NCT01222299|"~     The purpose of this study is to examine the safety and efficacy of bepotastine besilate~     nasal product in seasonal allergic rhinitis patients.~   "
140000|NCT01222286|"~     The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of~     two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.~   "
140001|NCT01222273|"~     The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to~     make their blood levels of the vitamin higher, will reduce the allergic response in their~     body and make the symptoms caused by ABPA better.~   "
140002|NCT01222260|"~     The study is being done to see if the combination of bendamustine and dexamethasone will~     help people with amyloidosis that has returned after standard treatment, and to to estimate~     the partial hematologic response rate (PHR).~   "
140003|NCT01222247|"~     Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely~     to be admitted to a special care nursery, and more likely to suffer respiratory~     complications than infants born at term. The use of antenatal corticosteroids has been shown~     to improve lung function in very premature infants, but has not been evaluated in those~     likely to deliver in the late preterm period.~      This research study will attempt to answer the following primary research question: Do~     steroids, compared to no steroids, decrease babies' need for oxygen support when given to~     pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks~     gestation? The research study will also collect information on whether steroids improve the~     chances that the baby will not get sick from other causes.~   "
140004|NCT01222234|"~     This investigation will consist of a prospective study utilizing two separate populations of~     patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one~     with normal renal function.~   "
140005|NCT01222221|"~     RATIONALE: Vaccines made from peptides may help the body build an effective immune response~     to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine~     therapy together with temozolomide and radiation therapy may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given~     together with temozolomide and radiation therapy in treating patients with newly diagnosed~     glioblastoma multiforme.~   "
140006|NCT01222208|"~     A prospective, randomized controlled study, using stable isotope methodology, is proposed to~     determine whether an oral nutrition support regimen, containing pressurized whey protein and~     glucose, is more effective at normalizing the metabolic response to surgery than a standard~     peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose,~     in colorectal surgical patients studied before and after surgery. The effectiveness of the~     nutrition support regimens will be determined by: whole body protein balance, synthesis~     rates of hepatic secretory proteins, resting energy expenditure and substrate utilization,~     as well as circulating metabolites concentrations.~   "
140007|NCT01222195|"~     The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa~     given together will help to control the need for transfusions in patients with low to~     intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also~     be studied.~   "
140033|NCT01221857|"~     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a~     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second,~     Unmanipulated CBU in Patients with Hematological Malignancies~   "
140010|NCT01222156|"~     The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote~     navigation system which is comprised of a magnetic chamber of eight electromagnets around~     the patient torso. The system can change the magnetic field almost instantaneously and~     enables almost real time manipulation of a special magnetic catheter (Maxwell mapping~     catheter) which results in accurate, repeatable, rapid and safe target acquisition within~     the four chambers of the human heart.~      The trial is a prospective, non-randomized, clinical one designed to test the study~     hypotheses of (a) technical equivalence of the study device in comparison to other magnetic~     remote navigation systems, (b) performance equivalence or non-inferiority of the study~     device target acquisition capability compared to presently used catheter navigation~     techniques, and (c) safety equivalence or non-inferiority of the study device in comparison~     to catheter navigation devices using other navigation techniques.~   "
140011|NCT01222143|"~     This is a phase I/II open-label study that is evaluating the toxicity and efficacy of~     nilotinib combined with mitoxantrone, etoposide, and high-dose cytarabine (NOVE-HiDAC)~     chemotherapy for patients with poor-risk acute myeloid leukemia (AML). There are two parts~     to the study. The first part (Phase I) will determine the maximum dose of nilotinib that can~     safely be given when combined with NOVE-HiDAC. This dose will then be used in combination~     with the NOVE-HiDAC regimen in the second part of the study (Phase II), which will evaluate~     the antileukemic activity of the treatment. The patients who achieve complete remission from~     the induction therapy (1 cycle) will then receive consolidation therapy combined with~     nilotinib (maximum of 2 cycles).~      The patient population for this study will have AML and will fall into a poor risk category.~     This means they have persistent leukemia after induction therapy, they relapse within two~     years of achieving complete remission with induction therapy, or they have certain poor risk~     features at diagnosis. The AML cells will also be positive for c-kit (a stem cell factor~     receptor), which is involved in cancer cell growth. Nilotinib is a drug that blocks the~     effects of c-kit. Using this drug in combination with chemotherapy may improve ability of~     the chemotherapy drugs to kill leukemia cells. This may then increase the chances of the~     leukemia going into complete remission.~   "
140012|NCT01222130|"~     This study is designed to develop and evaluate a set of non-virologic diagnostic algorithms~     to monitor HIV-exposed children of unknown infection status for treatment eligibility during~     the first year of life. The results of this cross sectional study are expected to be used in~     development of a series of non-virologic algorithms to determining treatment eligibility~     among HIV-exposed children in settings where polymerase chain reaction (PCR) testing is not~     available and to guide the judicious use of PCR testing among HIV-exposed children in~     settings where PCR is available. These results will directly inform program implementation~     in Zambia.~   "
140013|NCT01222117|"~     The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing~     different delivery regimens in patients with peripheral arterial occlusion. The study~     includes a blinded plasminogen activator treatment group and a blinded plasminogen activator~     placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250~     mg doses.~   "
140014|NCT01222104|"~     The purpose of this study is to collect data on the standard of care use of the St. Jude~     Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in~     diagnostic and/or interventional radiology patient populations.~   "
140015|NCT01222091|"~     This research study explores whether a beta-blocker can prevent a person from becoming more~     sensitive to pain after administration of an opioid. Beta blockers inhibit the sympathetic~     (fight or flight) response and are often used to treat angina and high blood pressure. In a~     previous study in human volunteers, the investigators demonstrated an increased sensitivity~     to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to~     identify a possible inhibitor of this phenomenon.~   "
140016|NCT01222078|"~     The purpose of this study to assess the safety and tolerability of re-dosing at 6 months~     with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with~     newly diagnosed type 1 diabetes mellitus~   "
140017|NCT01222065|"~     The proposed human clinical studies have three main objectives:~        1. To determine reproducibility of peripapillary birefringence maps and identify features~          that measure the health of the RNFL.~        2. To determine the normal variation in the birefringence maps with age.~        3. To develop and test a classifier for glaucoma based on the birefringence maps using a~          case-control clinical trial.~      This study is a case-control study intended to optimize feature selection for a future~     multi-center blinded study. The proposed clinical study does not measure conversion from~     normal to glaucoma.~   "
140018|NCT01222052|"~     In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The~     identification of this subgroup can be based either on clinical and pathological or on~     tumour-biological criteria. Due to their high prognostic impact, the tumour-biological~     invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1)~     are potential candidates to effectively assess the risk of relapse in node-negative breast~     cancer. This study is aimed to compare the risk assessment by the traditional~     clinico-pathological factors and by tumour-biological factors. The second study question~     refers to the comparison between an adjuvant combination treatment with FE100C*6 and a~     sequential treatment with FE100C*3 and Docetaxel*3.~   "
140019|NCT01222039|"~     The main purpose of this trial is to assess the safety and feasibility of treatment with~     two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro~     in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed~     chronic and extensive graft versus host disease (GVHD).~      Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not~     express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation~     of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting~     cell division and maintaining these cells in a quiescent state. This supports the hypothesis~     that MSCs are universal suppressors.~   "
140020|NCT01222026|"~     Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are~     treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful~     surgical treatment of pHPT.~      Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or~     osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD~     than placebo treated patients.~   "
140022|NCT01222000|"~     Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of~     keratinization of the skin which results in a severe generalized cutaneous xerosis with dark~     brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia.~     They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1~     (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the~     triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the~     cytochrome p450 ( CYP4F2).~      No etiological treatment is available. Symptomatic treatment consists on twice application~     of emollients and keratolytic ointments which decrease the dryness of the skin and reduce~     scales. Oral isotretinoin is usually partially effective but is only suspensive and has~     numerous side effects.~      Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from~     green tea increases the differentiation of the normal human keratinocytes, as showedb by the~     increase of the involucrine, TG1 and caspase-14 genes expression.~      The main objective of this pilot study is to estimate the action and the tolerance of a~     daily application of topical Polyphénon E 10% ® to improve the desquamation and the~     cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.~      The secondary objectives~        -  To estimate the duration of remission obtained after the treatment~        -  To estimate the action of cutaneous Veregen® to improve the palmar and plantar~          involvement.~        -  To estimate the action of cutaneous Veregen on the pruritus~        -  And to estimate the global level of acceptability by the patient of the Veregen 10 %~   "
140023|NCT01221987|"~     The current study will elucidate the human papillomavirus type distribution in a population~     of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical~     cancer in Sri Lanka.~   "
140024|NCT01221974|"~     The purpose of this study is to gather safety data related to the use of Essure®~     micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during~     pregnancy and to collect data with regard to implantation rates, clinical pregnancy rates,~     and pregnancy outcomes.~   "
140025|NCT01221961|"~     This is a study designed to compare the agreement of hemoglobin (Hb) measurements,~     documented at specific time points (the time a blood sample was obtained by the standard~     clinical care after physician/nurse orders it and, during that same time, the Hb value~     recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major~     spine surgery procedure (depending on how many times the physician/nurse orders the Hb value~     to be tested), between the standard clinical practice {intermittent measure of Hb [Cedar~     Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous,~     non-invasive Hb level measurements)*.~   "
140026|NCT01221948|"~     The purpose of this study is to document patient outcomes, including effectiveness, safety,~     and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS)~     Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment~     of moderate to severe idiopathic Parkinson's Disease (PD).~   "
140027|NCT01221935|"~     The goal of this observational study is to learn about how Pristiq is currently being used~     in general practice and how psychiatrists and primary care physicians currently perceive~     Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for~     major depressive disorder (MDD).~   "
140028|NCT01221922|"~     The purpose of this study is to evaluate the RevLite Q-Switched Neodymium:~     Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types~     (Fitzpatrick Skin Types III, IV, V and VI).~   "
140029|NCT01221909|"~     Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a~     prospective, double blind, placebo controlled study.~      The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding~     in DCR surgery, and might reduce the duration of the surgery.~   "
140030|NCT01221896|"~     The purpose of the study is to determine a possible input of C11-Choline PET/CT in~     identification and localization of a parathyroid adenoma (PTA).~      Preoperative localization of a PTA has been previously documented in multiple series, and is~     usually based on scintigraphy and on US.~      Currently, the conventional technique for localization of a PTA is a dual-isotope scan with~     Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes~     two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.~      In addition, there is no anatomical imaging and further correlation with US is usually~     recommended.~      In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection,~     and provides data of higher resolution of functional (PET) and anatomical imaging (CT).~      Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m~     pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT~     of a chest is: 0.3128 - 0.8628rem.~   "
140031|NCT01221883|"~     PTSD is a pervasive and frequent disorder. Early psychological treatment - but not~     pharmacology - effectively prevent PTSD.~      Current pharmacological studies did not include treatment given immediately after trauma~     exposure.~      However, a recent study of opiates suggests that their early administration may reduce the~     likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) -~     within an adequate window of time.~      Benzodiazepines are often used to reduce anxiety and agitation during stressful situations -~     including traumatic event.~      These compounds may increase the likelihood of developing PTSD when administered few days~     after the traumatic event - but their effect as an immediate intervention has not been~     studied - despite their frequent and uninformed use at this stage.~      This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory~     following traumatic event in a randomized controlled design.~      Following the studies of opiates it is hoped that diazepam, administered within hours of the~     traumatic event, and before the first night sleep (a memory consolidating condition) will~     reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and~     thus the investigators posit a bidirectional hypothesis.~      The importance of this work is that it will provide the necessary evidence to sanction a~     frequently practiced use of benzodiazepines.~   "
140032|NCT01221870|"~     The intravenously administered taxane, paclitaxel, is one of the most commonly employed~     agents for the treatment of both localized and advanced breast cancer.~      Tesetaxel is an orally administered taxane that is in development as first- and second-line~     treatment for patients with advanced cancers. This study is being undertaken to determine~     the efficacy and safety of tesetaxel administered as first-line therapy to patients with~     metastatic breast cancer.~   "
140034|NCT01221844|"~     The purpose of this study is to determine whether bovine lactoferrin is effective in~     preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia~     affected women during pregnancy.~      The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized~     by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron~     deficiency and iron deficiency anemia in pregnant women.~   "
140035|NCT01221831|"~     This is an open-label, multi-centre, comparative study in young, healthy, female volunteers~     of reproductive age.~      Primary objective:~      - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal~     bleeding patterns (cycle control), in comparison with a combined oral contraceptive~     containing estradiol valerate and dienogest~      Secondary objectives:~        -  To investigate ovulation inhibition~        -  To investigate the effect on SHBG~        -  To assess pregnancy rate~        -  To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight~        -  To investigate return of menstruation after treatment~        -  To evaluate general safety and acceptability~   "
140036|NCT01221818|"~     The purpose of this study is to evaluate the safety and tolerability of single oral~     ascending doses of E6007 in healthy subjects.~   "
140037|NCT01221805|"~     The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with~     a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep~     Venous Thrombosis (DVT) in a 3 month follow-up.~   "
140038|NCT01221792|"~     The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac~     effect, will reduce symptoms of Post Traumatic Stress Disorder.~   "
140039|NCT01221779|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     enhance the out of intensive language therapy in chronic aphasia~   "
140040|NCT01221766|"~     This research study will help us learn more about how chronic graft-versus-host disease~     affects the skin, hair and nails. We are interested in knowing if hair and nail problems~     predict worse disease. This information may help us treat patients like you in the future.~   "
140041|NCT01221753|"~     In this research study, the investigators are studying whether a reduced dose of radiation~     when given with standard doses of chemotherapy can reduce side effects without compromising~     control of the cancer. An approved treatment for squamous cell carcinoma of the head and~     neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment~     is effective but has many immediate and long-term side effects. People who have squamous~     cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human~     papillomavirus (HPV) have been shown to have a high response to this treatment along with a~     high cure rate. The investigators think that by reducing the intensity of this treatment,~     they may be able to reduce immediate and long-term side effects which may lead to long term~     improvements in quality of life and function.~   "
140042|NCT01221740|"~     1. To show that patients with greater pain sensitivity will show greater improvement in~          their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than~          those with lower pain sensitivity, based on QST, after taking milnacipran.~        2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and~          side effects) with those patients who are either taking or not taking opioids for their~          pain 10 weeks after being prescribed milnacipran.~        3. To show that patients who are older, male, with more medical comorbidities, greater~          disability, and longer pain duration will report less improvement (pain, mood, sleep,~          health-related quality of life) and treatment satisfaction while taking milnacipran~          compared with others without such characteristics.~   "
140043|NCT01221727|"~     This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with~     osteoporosis.~   "
140044|NCT01221714|"~     To evaluate the safety and tolerability of two supplements in healthy subjects taken daily~     for six months.~   "
140045|NCT01221701|"~     This study develops and contrasts In-Home Cognitive Behavioral Therapy (IH-CBT), an adapted~     evidence-based treatment for depressed mothers participating in home visitation, with~     typical home visitation in which treatment may be obtained in the community. Mothers will be~     identified using a two step process consisting of administration of a screen and subsequent~     diagnosis of Major Depressive Disorder. The will then be randomized into the treatment and~     control conditions. A comprehensive assessment of depression and related areas of~     functioning will be administered at pre-treatment, post-treatment, and 3 month follow-up. It~     is hypothesized that IH-CBT will lead to broad and durable gains in mood and social support~     relative to those in typical home visitation.~   "
140046|NCT01221688|"~     GANEA 2 is a new trial based on patient treated for a large breast tumor with proven~     axillary involved nodes. Patients enrolled in this trial will have first an axillary~     sonography with fine needle punction in case of suspected nodes before NAC. This primary~     evaluation allow to determine two groups of patients : group 1 : patients with proven~     involved axillary nodes and group 2, patients without proven axillary involved nodes.~     Patients of group 1, the study group, will undergo SLNB and complete level I-II axillary~     lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II~     lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in~     the others cases. Patients of this last group will be followed 5 years in order to evaluate~     the risk of axillary relapse without lymphadenectomy.~   "
140047|NCT01221675|"~     Lung cancer is currently the leading cause of cancer death in both men and women in Europe,~     with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients~     indicates that the current recommended regimens are falling short. In addition, many of the~     commonly used chemotherapy agents are associated with severe nonhematologic toxicities that~     are often cumulative and nonreversible and impair quality of life in this essentially~     palliative setting. Therefore, agents with novel mechanisms of action and superior safety~     profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic~     antigen (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The~     investigators group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb)~     can deliver a higher radiation dose to a tumor than a directly radiolabeled anti-CEA~     antibody, and shows improved anti-tumor efficacy. This clinical trial is designed to assess~     PRAIT using an entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the~     treatment of CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell~     Lung Carcinoma (NSCLC)~   "
140048|NCT01221662|"~     Brain hypoperfusion patients may cause vascular dementia results from their hypoperfusion~     state except that is a risk factor for stroke. The most common clinical symptom of~     hypoperfusion syndrome is dizziness.Siwu tang is made of Angelica sinensis (Oliv.) Diels~     (當歸), Rehmannia glutinosa (Gaertn) Libosch (熟地黃), Paeonia lactiflora Pall (白芍), Ligusticum~     chuanxiong Hort (川芎), and that was used to treat patients with blood deficiency for several~     centuries. the purpose of the present study was to investigate the complementary effect of~     siwu tang on brain hypoperfusion syndrome patients~   "
140049|NCT01221649|"~     The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable~     of measuring the intrathoracic impedance on a daily basis and transmission of impedance~     trend data via the Home Monitoring technology. In future, this will allow for automatic~     early detection of imminent decompensation at a presymptomatic stage and immediate~     initialization of clinical meaningful therapeutic interventions preventing heart failure~     (HF) related hospitalizations. The aim of this investigation is to record long-term~     impedance trends in heart failure patients with and without heart failure related events~     (hospitalizations due to acute decompensation) in order to develop algorithms for~     device-based early detection and warning of HF deterioration accompanied by pulmonary~     congestion.~   "
140050|NCT01221636|"~     The purpose of this study is to determine whether the blood levels of abatacept drug product~     manufactured using High Metals and using Low Metals are comparable in healthy subjects.~   "
140051|NCT01221623|"~     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety~     and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200~     AA4500 and 100 placebo) men will be randomized. Subjects will be screened for study~     eligibility within 21 days before the initial injection of study drug in the first treatment~     cycle.~      Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or~     61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either~     AA4500 0.58 mg or placebo.~      In this study, qualified subjects may receive up to four treatment cycles; each cycle will~     be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will~     receive two injections of study drug with at least 24 hours but not more than 72 hours~     between injections. After the final injection of each treatment cycle, the investigator or~     qualified designee will model the penile plaque in an attempt to stretch or elongate the~     plaque. If the subject's penile curvature is reduced to < 15 degrees after the first,~     second, or third cycle of injections or if the investigator determines further treatment is~     not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment~     cycles will not be administered.~      Following the maximum of four treatment cycles, each subject will be followed for additional~     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365~     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive~     open-label AA4500 treatment after completing this study as part of another protocol.~   "
140052|NCT01221610|"~     A prospective, multi-centre, randomized controlled, First in Man study to assess the safety~     and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an~     uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal~     arteries.~   "
140053|NCT01221597|"~     This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety~     and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267~     AA4500 and 133 placebo) men will be randomized. Subjects will be screened for study~     eligibility within 21 days before the initial injection of study drug in the first treatment~     cycle.~      Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º~     to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1~     ratio either AA4500 0.58 mg or placebo.~      In this study, qualified subjects may receive up to four treatment cycles; each cycle will~     be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will~     receive two injections of study drug with at least 24 hours but not more than 72 hours~     between injections. After the final injection of each treatment cycle, the investigator or~     qualified designee will model the penile plaque in an attempt to stretch or elongate the~     plaque. If the subject's penile curvature is reduced to <15 degrees after the first, second,~     or third cycle of injections or if further treatment is not clinically indicated, subsequent~     treatment cycles will not be administered.~      Following the maximum of four treatment cycles, each subject will be followed for additional~     safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365~     (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive~     open-label AA4500 treatment after completing this study as part of another protocol.~   "
140054|NCT01221584|"~     The purpose of the study is to establish the proportion of patients on lipid-lowering~     pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific~     Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.~   "
140055|NCT01221571|"~     The aim of this study is to determine the safety, tolerability, pharmacokinetics and~     activity of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed~     Hodgkin lymphoma.~   "
140056|NCT01221558|"~     The hypothesis was that an increase in serum lycopene levels following supplementation with~     capsules containing natural lycopene rich tomato extract would reduce oxidative stress and~     improve endothelial function in healthy men with low intake of fruits and vegetables. A~     randomized double-blind, placebo-controlled study was designed to assess the changes in~     serum lycopene levels, oxidative stress and endothelial function in response to an 8-week~     treatment with lycopene supplementation.~   "
140057|NCT01221545|"~     The purpose of this study is to investigate safety and tolerability after high Single~     Ascending Oral Doses of AZD1656.~   "
140070|NCT01221376|"~     The purpose of this study is to evaluate the hematological, cytogenetic and molecular~     response to continuous-use of Imatinib in children with CML Ph+.~   "
140082|NCT01221220|"~     There is a need for effective weight control methods for obese children. Environmental~     strategies such as reducing the size of dishware and serving utensils, storing food out of~     view and reducing food consumption while watching television may reduce food intake without~     requiring conscious, cognitive self-control. The investigators propose to test these methods~     when added to a current state-of-the-art behavioral program.~   "
140058|NCT01221532|"~     The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients~     aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of~     prescription medication, discharge summary sent to primary care provider (PCP), and~     outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care~     plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse,~     development of personalized discharge plan, two phone calls from a nurse~     practitioner(NP)/physician assistant (PA) after discharge and availability of additional~     calls back from NP/PA, upon patient request, to help answer questions and assist patient's~     transition to outpatient care, and communication with primary care/subspecialty providers).~     The usual care and usual care plus intervention groups will be assessed for differences in~     mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days~     following discharge from the hospital.~      The discharge process from the hospital to home is frequently marked by poor quality and~     high risk of adverse events and readmissions. It has been hypothesized that better~     coordinated care, personalized patient education, and follow-up calls to identify potential~     sources of adverse events, such as medical complications and medication errors can reduce~     rehospitalization and emergency room visits following discharge from the hospital. Although~     these interventions have been shown to reduce combined hospital readmissions and emergency~     department visits in English-speaking patients, none has focused on elderly patients in a~     diverse urban public hospital setting that includes non-English-speakers, who might benefit~     more than other populations from enhanced services during and after discharge from the~     hospital. Further, these labor-intensive interventions are costly to implement, and it is~     unknown whether opportunity cost of providing additional services in a limited-resource~     environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical~     benefits.~   "
140059|NCT01221519|"~     The purpose of this study is to assess the relative bioavailability by measuring the extent~     and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.~   "
140060|NCT01221506|"~     All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug~     (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the~     treatment of advanced kidney cancer. In this study, the investigators plan to learn more~     about the way this drug works by using special scans (MRIs and Ultrasounds) to help evaluate~     how this drug is working on this disease. Approximately 20 people with advanced kidney~     cancer will be enrolled on this study.~   "
140061|NCT01221493|"~     To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in~     peripheral lung lesions~   "
140062|NCT01221480|"~     The aim of this observational study is to utilise the established record linkage data~     available in Tayside to investigate hospital admissions, exacerbations and mortality in~     COPD.~   "
140063|NCT01221467|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring~     life-long insulin therapy. Children and adolescents with T1D need regular insulin injections~     or the continuous insulin delivery using an insulin pump in order to keep blood glucose~     levels normal. The investigators know that keeping blood sugars in the normal range will~     help prevent long-term diabetes-related complications involving the eyes, kidneys and heart.~     However, achieving treatment goals can be very difficult as the tighter the investigators~     try to control blood glucose levels, the greater the risk to develop symptoms and signs of~     low glucose levels (hypoglycaemia). This is a particular problem at night and one solution~     is to develop a system whereby the amount of insulin injected is controlled by a computer~     and is very closely matched to the blood sugar levels on a continuous basis. This can be~     achieved by what is known as a closed-loop system where a small glucose sensor placed~     under the skin communicates with a computer containing an algorithm that drives an insulin~     pump. The investigators have been testing such a system in Cambridge over the last three~     years in children and have found that this system is effective at preventing nocturnal~     hypoglycaemia. The next stage of this research is to test the system for a longer period of~     time at home. In the present study the investigators are planning to study 16 adolescents~     aged 12-18 years on insulin pump therapy. During 21 nights glucose will be controlled by the~     computer and during the other 21 nights the subjects will make their own adjustments to the~     insulin therapy. The investigators will then analyze the data to determine the effect of the~     computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and~     reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia). Subjects'~     response to the use of the system in terms of life-style change, daily diabetes management~     and fear of hypoglycaemia will be assessed. The investigators will also test for longer term~     glucose control by measuring glycated haemoglobin and other blood parameters.~   "
140064|NCT01221454|"~     The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow~     stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B~     infection. The evaluation of the efficacy includes the level of serum alanine~     aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin~     time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week~     to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were~     also observed simultaneously.~   "
140065|NCT01221441|"~     The purpose of this study is to see if we can safely regenerate cartilage without invasive~     surgery using a biologic product called TissueGene-C.~   "
140066|NCT01221428|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for ulcerative colitis is safe and effective.~   "
140067|NCT01221415|"~     The primary objective of this study is to compare ultrasound versus nerve stimulator~     techniques for nerve localization when performing peripheral nerve blocks. Specifically the~     investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The~     investigators will be looking for differences in 1) time taken to locate the target nerve~     and inject local anesthetic 2) time from injection of local anesthetic to adequate surgical~     anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of~     adverse events 6) patient satisfaction.~   "
140068|NCT01221402|"~     Intermediate saphenous vein graft (SVG) lesions are common, have high rates of progression~     to severe lesions or occlusion, and are associated with high incidence of adverse clinical~     outcomes.~      The ALPINE-SVG trial is a randomized-controlled trial of extended-release niacin vs. placebo~     in patients with intermediate saphenous vein graft lesions. The main hypothesis of the study~     is that compared to placebo, niacin administration will result in reduction in percent~     atheroma volume at 12-month follow-up angiography.~   "
140069|NCT01221389|"~     Information on the management of casualties from the ongoing conflicts in Afghanistan and~     Iraq has brought in to question the traditional approach to blood transfusion in~     hemorrhaging patients. Present recommendations for when to transfuse plasma products is when~     coagulation tests become abnormal. The proposed trial will investigate whether the more~     aggressive plasma transfusion strategies as advocated from researchers based on the Central~     Asian conflicts is valid. Since a study to determine the full impact of an altered plasma~     transfusion practice would require thousands of patients, a feasibility trial is appropriate~     and is being proposed. The hypotheses are thus:~      Primary Hypothesis- A multicentre trial that investigates the earlier use of plasma in~     patients with hemorrhagic shock going for emergency surgery will be feasible.~      Secondary Hypotheses- The early use of a universal donor blood plasma (AB+ plasma) in~     patients with shock due to blood loss (i.e. hemorrhagic) going for emergency surgery will~     reduce overall exposure to the total number of blood donor products (so-called allogeneic~     blood exposure). A reduction in allogeneic blood exposure would then reduce the total number~     of blood transfusion-related complications. The early use of this plasma product is safe and~     will not increase the incidence of blood clotting or other transfusion-related~     complications.~   "
140071|NCT01221363|"~     Recent studies have suggested that prolonged daily sitting time may in itself have a~     negative effect on health, even in people who engage in daily physical activity.~      The aim of the present study is to explore whether individually tailored lifestyle~     counselling aimed at reducing TV-viewing and other sedentary activities during leisure time~     and at work, can reduce sitting time and waist circumference, weight and blood pressure; and~     improve serum lipid levels. From a population-based health survey, 150 adult men and women~     with more than 3.5 hours of daily leisure time sitting time are recruited and randomly~     assigned to 1) an intervention group or 2) a control group. The intervention group will~     participate in 4 individually tailored lifestyle intervention sessions focussing on~     reduction of daily sitting time. The control group will receive no intervention.~   "
140072|NCT01221350|"~     The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid~     to improve the quality of life of patients with asthma.~      The investigators will administrate 600 mg lipoic acid orally on a daily basis during two~     months concurrent with the patient anti-asthmatic therapy and evaluate the effects on~     resulting pulmonary function, inflammatory and oxidative stress biomarkers and~     health-related quality of life previous to the initial of the treatment and at 60 days of~     the supplementary therapy.~   "
140073|NCT01221337|"~     The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal~     circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy~     during a haemodialysis session. In the cases of multiple coagulation defects having high~     haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended~     to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low~     heparin or heparin free haemodialysis have been proposed till now, without a real success.~     The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 %~     successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated~     polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic~     properties and a capacity to improve the haemorrheological factors of human blood, hence~     having a promising future to perform a successful haemodialysis session with less or without~     heparin. This randomised, multi-centric, cross-over and open study has been designed to~     compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of~     5% and an absolute accepted difference of 12 %.~   "
140074|NCT01221324|"~     Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive~     protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this~     study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory~     complications after open resection of colorectal cancer.~   "
140075|NCT01221311|"~     The current standard of care for benign bile duct strictures involves placement of multiple~     plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch~     it open. This approach necessitates multiple procedures which may extend over one year~     before the stricture is adequately dilated. The investigators propose a study comparing the~     standard approach of plastic stenting with the use of newer, fully coated metallic stents~     which are self-expandable, thereby permitting successful dilation of benign bile duct~     strictures with fewer procedures.~   "
140076|NCT01221298|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072~     and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C~     virus (HCV) infection.~   "
140077|NCT01221285|"~     This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous~     Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial~     allergic rhinitis, asthma, or both.~   "
140078|NCT01221272|"~     This study enrolled participants with documented exercise-induced myocardial ischemia in~     order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow~     to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion~     defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission~     computed tomography (SPECT) myocardial perfusion imaging (MPI).~      This was a 2-period crossover study. The last dose of each period must have been taken 3-4~     hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was~     performed at the end of Period 1, participants discontinued the treatment they were~     randomized to for that period and began the other treatment in Period 2.~   "
140079|NCT01221259|"~     This study is designed as a single ascending dose study in healthy subjects to evaluate~     safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and~     Cerebrospinal (CSF) following single oral doses of E2212.~   "
140080|NCT01221246|"~     The purpose of this research study is to determine whether the investigational drug GM602,~     is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot~     blocking the flow of blood through one, or more of the blood vessels supplying the brain)~     when administered up to 18 hours after symptoms begin.~   "
140081|NCT01221233|"~     Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size~     and function to inform clinical practice. US has been shown to be a reliable and valid tool~     for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity~     during sub-maximal contractions in younger populations. Younger adults with low back pain as~     compared with healthy adults without pain demonstrate smaller back muscle size, lower back~     muscle activity, and greater back muscle asymmetry (differences in right side compared with~     left side).~      No trials are published evaluating muscle adaptations using US in response to clinical~     treatments for low back pain in the older adult population. Increased muscle size and~     improved muscle symmetry have been reported in younger adults with low back pain who~     participate in low back stabilization exercises. These exercises use voluntary contractions~     of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical~     Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary~     activity is impaired and increases muscle size. Most studies assessing muscle size and~     activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps),~     while the impact of NMES on the back muscles remains relatively unexplored. Given the~     potential to evaluate back muscle size and activity with US, this assessment tool may be~     used to document muscle adaptations to a clinical intervention in older adults with low back~     pain.~      The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus~     lumbar stabilization exercises is superior to lumbar stabilization exercises for improving~     back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in~     older adults with chronic low back pain (i.e. low back pain of greater than 3 months).~     Muscle size, activity, and symmetry will be assessed using US before and after the~     treatments to determine if the treatments positively impact muscle. Secondary clinical~     measures of success will include improvements in physical, psychological, and social~     function pre- to post-treatment.~   "
140104|NCT01220934|"~     This observational, multicenter study will assess the efficacy and safety of Herceptin~     (trastuzumab) in routine clinical practice in patients with HER2-positive advanced~     adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be~     collected for approximately 12 months.~   "
140083|NCT01221207|"~     Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers~     (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week~     randomized clinical trial of 225 patients in community care in three university medical~     center diabetes clinics.~      Aim 2. To compare the frequency of complications such as soft tissue and bone infections,~     iatrogenic wounds, falls and fall related injuries, and amputations among patients treated~     with TCC, ITCC and RCW to heal diabetic foot ulcers.~      Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment~     groups. Using computerized activity monitors which time-stamp each step, we will evaluate~     both degree and magnitude of activity between groups.~      Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications~     during the course of therapy.~   "
140084|NCT01221194|"~     1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings,~          PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.~        2. To evaluate perceived health-related quality of life as compared to guideline directed~          usual care in patients who use the PFC stockings.~   "
140085|NCT01221181|"~     This is an open label, non-blinded, proof of concept efficacy and safety study of eculizumab~     in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult~     patients with these diseases who have > 1 gram of proteinuria or a decreased glomerular~     filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular~     diseases. They will be treated with eculizumab for one year. The goals will be to determine~     whether treatment leads to an improvement in kidney function, defined by remissions of~     proteinuria and improvements in estimated GFR (measured by serum creatinine), and to~     improvement in histologic parameters, including percentage of non-affected glomeruli,~     interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of~     electron dense deposits by electron microscopy.~      All enrolled subjects will receive eculizumab treatment for one year. There will be 29 study~     visits over 53 weeks. The goal is to determine whether this treatment will improve kidney~     function, as evidenced by less protein in the urine and improved lab results.~      An EXTENSION TREATMENT PHASE has been added. After completing the study, patients are~     followed with labs every four weeks as per standard of care. If labs suggest a relapse, they~     will be allowed to continue on therapy at the previous dosage until this drug receives FDA~     approval for this indication. Treatment intervals and dosage are identical to the original~     study.~   "
140086|NCT01221168|"~     The aims of the study are:~        -  to identify genetic and molecular factors (rare mutations, polymorphisms) involved in~          the natural history of prostate cancers and their response to treatment,~        -  to evaluate and deduce their medical applications for screening and therapeutic~          management of these tumors.~   "
140087|NCT01221155|"~     Manual treatment offers benefit to some patients suffering from back pain but little is~     known about which of the many tissue layers are affected. This study will help identify~     which tissues may be stimulated sufficiently to be a source for the clinical effects of~     treatment and to prioritize future work to understand mechanisms of back pain and to improve~     care.~      Current soft-tissue ultrasound elastography techniques, under static condition, will be~     extended to quantify relative displacement and strains(active and passive)across the depth~     of tissue strata that arise from small amplitude motions during continuous passive motion~     clinical procedures and in weight bearing postures. Relative movement of the stratified~     layers of the back, from treatment and task-generated perturbations, will enable the~     elastography interrogation of the tissue.~   "
140088|NCT01221142|"~     In this pilot study the researchers will investigate efficacy of hypothermia in the early~     stage of treatment patients with primary intracerebral hemorrhage.~   "
140089|NCT01221129|"~     The specific aim of this protocol is to examine differential expression of specific mRNAs~     and proteins that occur when the dietary intake of zinc is acutely reduced below the dietary~     requirement for a period of ten days.~   "
140090|NCT01221116|"~     Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics~     after cardiac surgery and lead to reduced stay at intensive care unit~   "
140091|NCT01221103|"~     The rationale for this study design is based on the fact that the maximum tolerated dose~     (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The~     choice of the doses for the combination is based on the investigators unpublished clinical~     experience, as well as inferred from extensive experimental data on the use of other~     monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of~     the 2 main component drugs is the MTD of each drug as single agent.~   "
140092|NCT01221090|"~     To evaluate the effectiveness of two different diabetes self-management approaches (Personal~     Digital Assistant-based intervention & Chronic Disease Self-Management Program) to reduce~     health disparities in minority, rural residents, and other underserved populations with type~     2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with~     T2DM will be found to experience disparities in diabetes self-management treatment protocols~     and clinical outcomes, which persist even when controlling for age, gender, obesity, and~     insurance status; 2) Patients with T2DM who reside in more rural areas will be found to~     experience disparities in diabetes self-management treatment protocols and clinical outcomes~     as compared to more urban counterparts, controlling for age, gender, race/ethnicity,~     obesity, and insurance status; 3) The introduction of CSDMP and HIT protocols will improve~     diabetes-related self management behaviors, reduce HBA1c values, and increase quality of~     life in persons with T2DM as compared to controls. A combined intervention approach will~     result in the greatest reductions; 4) Health improvements following the introduction of~     CDSMP, HIT or CDSMP/HIT protocols in persons with T2DM compared to controls will be more~     marked in racial/ethnic minority patients and those patients residing in rural areas; 5) The~     introduction of self-management interventions will be cost-effective in reducing HbA1c~     values over time, and associated health care utilization including overall reduction in ER~     and acute care hospital admissions; 6) Although there is little prior research in this area~     to guide specific hypotheses, we hypothesize that, overall, there will be no significant~     cost-effective differential in CDSMP as compared to HIT approaches, although the~     cost-effective ratio may be stronger in particular subpopulations. The combined approach~     will have higher costs, but is also anticipated to have a higher cost-benefit ratio for~     minority populations; 7) The majority of clinicians will be willing to let their patients~     enroll in the study and will reinforce intervention protocols; and 8) These interventions~     can be embedded into existing health care structures. At the end of the study, Scott and~     White will institutionalize cost-effective treatment protocols.~   "
140093|NCT01221077|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib~     (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer~     (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who~     are Chemonaive.~   "
140094|NCT01221064|"~     The aim of the study is to assess whether early drainage removal in patients with less than~     150ml of lymph in postoperative day 1 can reduce total lymphorrhoea~   "
140105|NCT01220921|"~     The creation of a multi-center cooperative research group encompassing academic and~     community-based spinal practices . . .~   "
140095|NCT01221051|"~     The purpose with this study was to compare blood loss and women's experience of afterpains~     during the third stage when handled with active or expectant management of the third stage~     of labour.~      Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss >1000 mL between the two~     groups with 80% power (α=0.05), at least 726 subjects were required in each group.~      Hypothesis 2. Afterpains are more pronounced in active compared to expectant management~     during the third stage of labour~   "
140096|NCT01221038|"~     Background:~      Heat stroke is defined as a condition where the body temperature raises to dangerous level~     that may cause harm to body tissues and lead to multi-system clinical and pathological~     manifestations that might lead to death. Among heat stroke survivors a defect in~     thermoregulation develops as a consequence. In the IDF, every soldier who had a heat stroke,~     or is suspected to have had a heat stroke, must pass a heat intolerance test in the Unit of~     Military Physiology, after a rest period of 4-6 from the incident, which is the approximate~     period for thermoregulation to recuperate from the injury after a heat stroke. Until the~     heat intolerance test, the soldier must not train to avoid a repeat incident of heat stroke.~     The soldiers' ability to return to active duty is based on the results of the exam. The heat~     tolerance test and its criteria have been developed in the Physiology Unit throughout years~     of experience, and have been proved and adopted by several labs in Europe and in the United~     States. The criteria generally include baseline temperature and heart rate, and are based~     upon the physiological response of healthy men (soldiers) in the physical effort involved in~     the test.In recent years there is a growing trend in the IDF to integrate female soldiers in~     combat divisions. As a result, these females are exposed to physical efforts in various~     climate conditions as a part of their training, or a part of their active duty missions in~     the division. Therefore, the probability of an incidence of heat injuries increases among~     these soldiers.Research results indicate differences in the efficiency of thermoregulation~     mechanisms between men and women:~      It has been found that in women the threshold for sweating and vasodilatation is higher than~     in males. Additionally, although in women the mechanism for sweating is slower, and occurs~     at a later period, it is found that the relative part of sweating that evaporates is higher,~     so that women evaporate sweat more efficiently (to make up for the lower sweat quantities~     compared to men). Reduced efficiency of the thermoregulation mechanisms in women is also~     attributed to the differences in mass, body composition (fat and muscle mass), and physical~     fitness between the genders. In addition, the physiological changes that occur during the~     different phases of the menstrual cycle can affect core temperature at rest and~     thermoregulation. Different reports in literature indicate a decreased thermoregulation~     capacity in the luteal phase of the menstrual cycle compared to the follicular phase.~     Apparently, thermoregulation capabilities in exercise are linked to progesterone blood~     levels, which are influenced by contraceptive pills and with the phase of the menstrual~     cycle.~      There are two factors that can cause incorrect diagnosis of the level of heat tolerance in~     females when the specific test is interpreted based on set criteria for men. These criteria~     are:~        1. The physiological differences between men and women~        2. The differences in women based on menstrual cycle and using contraceptive pills.~      Thus, there is a need to characterize and establish the normal values in a heat tolerance~     test for young females compared to males, and also to correspond to current menstrual cycle~     phase and use of contraceptive pills.~      Methods:~      on the first day of the research, the participants will undergo anthropometric examinations~     (measuring height, weight, BMI, fat content, maximum oxygen consumption). In addition, the~     participants will undergo a heat tolerance test protocol. The heat tolerance test will be~     conducted twice in every participant - once in the follicular phase of the menstrual cycle,~     and a second time in the luteal phase of the cycle. During the protocol, the following~     information will be collected from each participant: heart rate, core temperature, skin~     temperature in three locations (chest, arm, and leg), oxygen consumption and liquid balance.~      The results of the examination will be compared to results of male participants who have~     previously undergone the heat tolerance test in the Unit of Military Physiology.~      Contribution to IDF:~      the research will allow administrating heat tolerance tests accurately and reliably to~     female soldiers that have been affected by heat injuries or are suspected to be heat~     intolerant.~   "
140097|NCT01221025|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted~     in three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III)~     undergoing primary elective abdominal surgery with general anesthesia will be involved in~     this study. According to previous studies and our pilot trial, the sample size was estimated~     to be 900 subjects (each center recruiting 300 patients). All eligible patients will be~     randomly assigned to one of two groups: study group receiving parecoxib and control group~     receiving normal saline. All patients will be managed with by a standard clinical anesthesia~     protocol with a sevoflurane-based general anesthesia with continuous intravenous~     remifentanil, followed by a postoperative PCA with morphine. The emergence delirium will be~     evaluated by two persons blinding to medication and grouping using Riker sedation-agitation~     scale immediately since tracheal extubation and at specific time points until patients being~     discharged from PACU. Pain intensity assessments and pain relief assessments will also be~     conducted by the patients at given time points in 2 days postoperatively. The~     morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.~   "
140098|NCT01221012|"~     Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC)~     protective garments, amplify thermal stress because of the inherent properties of the~     clothing material. High insulation coefficient and low water vapor permeability of the~     protective cloth limit the ability of sweat to readily evaporate, which consequently result~     with a significant elevation of body temperature and with excessive body fluid loss (because~     of inefficient sweating) that might result with significant dehydration.~      Combat soldiers require to perform intense physical activities under hostile environmental~     conditions, including in contaminated areas that need the use of protective garments. The~     ability to fulfill a mission derives from the soldier's professionalism and from his~     physiological limits. It is well established that wearing protective garments affect~     tolerance time (TT) and performance.~      To operate in contaminated areas suitable protective garments should be worn. The inherent~     characteristics of the current protective garments limit, however, the effective working~     periods with such an ensemble, which is further aggravated in hot climate. Thus, in an~     attempt to increase TT and enhance work effectiveness, improved protective garments, which~     result with a lessened heat-stress, are under different stages of development.~      The relative influence of air permeability properties, garment weight and garment~     construction on heat stress and physiological strain will be investigated.~      The results will be quantified in terms of body temperatures, heart rate, fluid balance,~     subjective sensation and the maximum wear time (if necessary extrapolated).~   "
140099|NCT01220999|"~     This is a clinical trial of CS-1008 which is a humanized monoclonal antibody.~      This trial explores where CS-1008 distributes in the body, and the activity of CS-1008 in~     patients with metastatic colorectal cancer. The purpose of this study is to give patients~     with metastatic colorectal cancer a series of different CS-1008 antibody doses in order to:~        -  Study how the dose of CS-1008 effects where the CS-1008 distributes in the body~          (biodistribution), how long it circulates in blood (pharmacokinetics) and how much~          attaches to tumour (tumour uptake). These issues are studied after the initial infusion~          of 111In-CS-1008 (CS-1008 tagged with a small amount of radioactive Indium - also~          called Indium-111 or 111In), and also during and after a cycle of weekly infusions of~          CS-1008 antibody.~        -  Study changes in the function (metabolism) of tumour cells following CS-1008~          administration.~        -  Assess whether repeat doses of CS-1008 cause shrinkage of the tumour.~        -  Study whether experimental treatment with CS-1008 changes chemicals in the blood that~          may indicate tumour cell death (serum apoptosis biomarkers) and/or tumour response to~          treatment (serum tumour biomarkers (CEA - carcinoembryonic antigen)).~   "
140100|NCT01220986|"~     The aim of this study is to characterize Kupffer cell activity and activation of the innate~     immune response in the early phase of liver regeneration after right hepatectomy. The~     investigators hypothesise that liver regeneration after right hepatectomy in humans is~     associated with Kupffer cell activation and initiation of the innate immune response and~     that impaired liver regeneration, liver failure and sepsis following liver resection are~     associated with Kupffer cell dysfunction and an impaired innate immune response. The~     objectives for this study are to characterise Kupffer cell activity and the innate immune~     response in human liver before and after right hepatectomy.~   "
140101|NCT01220973|"~     RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving atorvastatin calcium together with~     celecoxib may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with~     celecoxib works in treating patients with rising PSA levels after local therapy for prostate~     cancer.~   "
140102|NCT01220960|"~     As studies continue to debate the effects of quality of life on survival, increased~     attention is being focused on investigating complementary alternative therapies to boost~     overall total health in cancer patients . Art therapy is an interesting growing field, which~     has shown promise to positively influence quality of life in the pediatric and adult~     oncology population alike. As there is a paucity of well controlled complete studies in this~     field, the investigators propose to study the impact of art therapy sessions in women with~     breast cancer with quantitative and qualitative analysis of emotional health and physical~     symptoms.~      The results of the investigators study will have widespread applicability to oncology~     programs that wish to offer/implement such sessions to their palliative and non-palliative~     outpatients in an effort to address the important concept of whole person care.~   "
140103|NCT01220947|"~     This randomized, open-label, active-controlled, parallel-group study will evaluate the~     sustained virological response of danoprevir boosted with low dose ritonavir in combination~     with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in~     treatment-naive patients with chronic Hepatitis C.~   "
140106|NCT01220908|"~     The objective of this study is to demonstrate the safety of the PneumRx Lung Volume~     Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is~     a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is~     designed as an alternative to lung volume reduction surgery, potentially achieving the~     desired reduction in lung volume limiting the risks associated with major surgery, such as~     illness or death. This device is deployed through a bronchoscope and requires no incision.~   "
140107|NCT01220895|"~     The purpose of this study is to evaluate the potential clinical benefit of pre-emptive~     cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted~     allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV~     reactivation.~   "
140108|NCT01220882|"~     This study is being done for two reasons: 1) to evaluate growth problems in the hip in~     patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults,~     and 2) to help doctors determine which patients are at risk for developing a SCFE on their~     opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a~     SCFE on their other side. Being able to better determine which patients are at risk for~     developing a SCFE on the other side will help physicians better monitor patients with a~     history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By~     studying the growth centers seen on X-rays of your child's legs and elbow, the investigators~     may be able to better predict which children with a SCFE are at risk for developing a SCFE~     on their opposite hip and potential growth problems as they continue to grow.~   "
140109|NCT01220869|"~     A phase III trial investigating the efficacy and safety of degarelix one-month depot in~     Taiwanese patients with prostate cancer.~   "
140110|NCT01220856|"~     Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury~     occurring after pancreatic islet transplantation. Reparixin is a novel and specific~     inhibitor of CXCL8. This study is designed to explore the efficacy of reparixin in~     preventing graft dysfunction after islet transplantation in type 1 diabetes patients (T1D).~   "
140111|NCT01220843|"~     The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on~     dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the~     effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a~     diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary~     phosphate. In addition, the investigators will describe the impact of the FGF23 level~     monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid~     hormone (iPTH), serum calcitriol and phosphaturia.~   "
140112|NCT01220830|"~     The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in~     cases of Multiple sclerosis.~      The evaluation will be done based on MRI findings, by clinical/ neurological examination and~     by assessment of quality of life before and after completion of therapy.~   "
140113|NCT01220817|"~     When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is~     effective in slowing the rise of PSA as measured by PSA doubling time in men following~     initial therapy for prostate cancer. Further, the investigators believe that POMx will be~     shown to be safe and well tolerated.~   "
140114|NCT01220804|"~     The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in~     diabetic retinas using a novel non-invasive approach based on the Fourier domain~     high-definition optical coherence tomograph (OCT).~   "
140115|NCT01220791|"~     Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently~     control late follicular progesterone rise during IVF treatment~   "
140116|NCT01220778|"~     Background: It is now generally accepted that an active lifestyle is beneficial for~     cognition, but can these benefits be transmitted for the active pregnant woman to her unborn~     child? This has been demonstrated in rats where the pups born of mothers who exercised~     during pregnancy had increased hippocampal neurogenesis and better memory and learning~     capabilities. Human studies tend to confirm this by looking at behavioral results, ie.~     better orientation and state regulation skills in newborns. The aim of the present study is~     to verify this on the electrophysiological level and to determine the effects of an active~     lifestyle during pregnancy on the newborn's brain development.~      Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise~     group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal~     intensity of 55% of their maximal aerobic capacity. The control group will not be given~     exercise counselling. Newborns' brain activity will be recorded using electroencephalography~     (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of~     the mismatch negativity (MMN), a component of the auditory event-related potential (ERP)~     that can be used to investigate the auditory sensory memory.~   "
140117|NCT01220765|"~     Rationale: The current standard of respiratory monitoring for patients during deep sedation~     is continuous pulse oximetry with visual assessment of the patient. Clinical research has~     demonstrated that depressed respiratory activity is a principal risk factor for hypoxemia~     during sedation. Capnography may provide early detection of alveolar hypoventilation before~     hypoxemia has occurred in nonintubated patients and thereby improve patient safety during~     sedation.~      Objective: At the Centre for Contraception, Sexuality and Abortion Leiden, abortion~     procedures are performed under deep sedation using propofol. Patient's monitoring is~     performed by nurses qualified in patient sedation management, using pulse oximetry and their~     clinical judgement. The aim of this study is to examine the effectiveness of capnography in~     early detection of alveolar hypoventilation during deep sedation in comparison to standard~     monitoring with pulse oximetry in abortion procedures.~      Study design: This protocol describes a prospective, open, randomized controlled trial with~     two study arms. All patients receive standard care of monitoring performed by the medical~     staff. The study investigates whether capnography prevents patients from having respiratory~     events during deep sedation in abortion procedures by early detection and therapy. Patients~     randomized to the standard care group receive standard of respiratory monitoring using pulse~     oximetry. In the capnography arm, respiratory monitoring is performed with pulse oximetry~     and capnography.~      Study population: The study population comprises female patients (≥ 18 years) undergoing~     abortion procedures during first or second trimester pregnancies. Abortion procedures are~     performed until 22 weeks of gestational age.~      Capnography: In addition application of capnography during deep sedation with propofol is~     performed. Before the trial starts, all nurses qualified in patient sedation management and~     abortion doctors will be trained in assessment of capnography. In the capnography arm,~     patients' breathing is additionally monitored with capnography. If alveolar hypoventilation~     is detected medical staff will intervene by arousing the patient, performing chin lift,~     repositioning the head, provision of oxygen, or abandon from giving additional propofol.~     These interventions represent the standard of care currently used by the clinical staff to~     respond to hypoventilation and hypoxemia.~      Main study parameters/endpoints: The primary outcome is the occurrence of oxygen saturations~     to ≤90% in the population, as measured by continuous pulse oximetry. Secondary study~     outcomes include occurrence of oxygen saturations < 80%, dose of administered propofol,~     arousal or movement of the patient during the procedure, airway interventions, early~     termination of the procedure due to respiratory problems, episodes of bradycardia, and~     administration of atropine.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks related to the conduct of this study are negligible and the burden~     minimal. Patients in both groups receive the current standard of care. Patients randomized~     in the capnography group could get benefit from the addition of capnography to the~     monitoring by early detection of alveolar hypoventilation. Capnography is a noninvasive~     measurement by means of a cannula under the nose, which before the sedation may tickle, but~     during sedation no inconvenience is expected.~   "
140118|NCT01220752|"~     The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity~     and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and~     carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local~     control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial~     includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal~     malignancies.~   "
140119|NCT01220739|"~     To assess the safety and preliminary efficacy of combining intravenous rt-PA with~     transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as~     NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin~     within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for~     each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an~     investigational device that provides noninvasive transcranial laser therapy to subjects~     diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared~     zone of the electromagnetic spectrum and is invisible to the naked eye.~   "
140120|NCT01220726|"~     This is a prospective, randomized, double-blind study comparing intravesical injection of~     BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following~     treatment groups:~      Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0),~     subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study~     duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a~     Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and~     270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.~      Subjects demonstrating an insufficient response to treatment may receive an open-label~     injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will~     re-commence Follow-up Visits and be followed for an additional 270 days.~   "
140121|NCT01220713|"~     The goal of this research is to serve as a demonstration project to determine the~     tolerability of individuals with persistent post-concussive symptoms from combat-related~     mild TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen)~     therapy, and determine the efficacy of HBO2 therapy.~   "
140122|NCT01220700|"~     The purpose of this study is to determine if suture material coated by antimicrobial agent~     triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric~     surgery compared to ordinary sutures.~      1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the~     Oulu University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus,~     Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email~     questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC~     criteria.~   "
140123|NCT01220687|"~     This study hopes to determine whether nitric oxide along with oxygen during the first 20~     minutes of life in infants needing help with breathing will reduce the percentage and total~     exposure to oxygen during that time frame. Although the use of oxygen in management of~     breathing is an important part of supporting baby immediately after delivery, there is more~     evidence that too much exposure to oxygen may lead to potential problems for your baby~     later. Oxygen exposure can be harmful to premature babies developing lungs.~   "
140124|NCT01220674|"~     The investigators are developing a computer-based neuropsychological assessment tool to help~     primary care physicians detect neurological and psychiatric disorders. To confirm the tool's~     efficacy, the investigators will first test the prototype against established tests. The~     investigators propose to collect preliminary data on a limited group of subjects and~     age-matched controls. Collecting data on a limited group of subjects provides early insight~     into how well the tool detects disease, how well patients understand the instructions and~     enjoy performing the tasks, and if particular trials or stimuli are too difficult or too~     easy for all subjects. With this information, the investigators can make adjustments to the~     tool if needed and collect additional data on revised versions of the tool. The data will be~     used to establish the validity, reliability and sensitivity of the tool to generate~     consistent and accurate scores. The investigators will initially focus on a limited age~     range (age fifty-five to seventy-five) and limited set of diseases (early dementias or mild~     cognitive impairment) to reduce variability within the patient and control groups and to~     gain more statistical power with a smaller group of subjects.~   "
140125|NCT01220661|"~     In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use~     of antibiotics for colorectal surgery is three doses.~      It has been reported that the surgical site infection rates of laparoscopic colorectal~     surgery are lower than open colorectal surgery. However, the evidence of proper application~     of antibiotic for laparoscopic colorectal surgery is still not enough.~      The investigators are researching the efficacy and safety of one dose prophylactic~     antibiotic in laparoscopic colorectal surgery.~   "
140126|NCT01220648|"~     This study will assess the maximum tolerated dose of low dose interferon in conjunction with~     nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia~     patients in chronic phase (CML-CP).~   "
140127|NCT01220635|"~     This study aims to evaluate the short-term and long-term efficacy of two preventative~     intervention approaches designed to support middle school youth.~   "
140128|NCT01220622|"~     The trial was designed to test the hypothesis that early treatment with nimodipine has a~     positive effect on cognition impairment after acute ischemic stroke.~   "
140129|NCT01220609|"~     This phase II trial is studying the side effects and how well ixabepilone works in treating~     patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with~     chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing.~   "
140130|NCT01220596|"~     Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with~     Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.~        -  Increased HBeAg seroconversion rate~        -  Increased HBsAg loss rate~        -  To define the best treatment condition for chronic HBV hepatitis patients~   "
140153|NCT01220297|"~     GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched~     related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL~   "
140131|NCT01220583|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. It is not yet known whether~     radiation therapy is more effective when given together with chemotherapy or alone after~     surgery in treating salivary gland tumors.~      PURPOSE: This randomized phase II trial is studying radiation therapy with or without~     chemotherapy to see how well it works in treating patients with high-risk malignant salivary~     gland tumors that have been removed by surgery.~   "
140132|NCT01220570|"~     This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or~     ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score~     among participants with breast cancer.~   "
140133|NCT01220557|"~     This study is a randomized prospective trial with 6-month follow up. A non-inferiority~     hypothesis is tested. A new developed treatment and education programme for type 1 diabetic~     patients (PRIMAS) will be tested compared to an established treatment and education~     programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up.~     Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive~     symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin~     treatment, hypoglycemia awareness.~   "
140134|NCT01220544|"~     Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of~     graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The~     effectiveness of allogeneic NK cells is a function of HLA-differences between donor and~     recipient that give rise to NK cell clones which do not express inhibitory receptors~     matching for the HLA molecules of the recipient. Aim of the study is to evaluate cellular~     therapy with alloreactive, IL-2 activated NK cells after transplantation of T-cell depleted~     stem cell grafts from one haplotype mismatched family donors in patients with hematological~     malignancies.~   "
140135|NCT01220531|"~     Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no~     thymus function, bone marrow stem cells do not develop into T cells, which fight infection.~     Complete DiGeorge anomaly patients cannot fight infection and are immunodeficient. Without~     successful treatment, cDGA patients usually die by age 2 years.~      Thymus transplantation with and without immunosuppression (drugs given before and after~     transplantation) has resulted in the development good T cell function in complete DiGeorge~     anomaly subjects.~      This Phase I/II study continues thymus transplantation safety and efficacy research for the~     treatment of complete DiGeorge anomaly. Eligible participants undergo thymus transplantation~     and biopsy. Immune function testing is continued for one year post-transplantation.~   "
140136|NCT01220518|"~     This study is the trial to demonstrate how our product is similar to remicade by comparing~     the results of blood samples in active Ankylosing Spondylitis patients.~   "
140137|NCT01220505|"~     The purpose of this Post Market Surveillance Validation is to document the performance and~     clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity~     Correction System.~   "
140138|NCT01220492|"~     Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized~     by distortion of the hepatic architecture and formation of regenerative nodules. The liver~     transplantation is one of the only effective therapies available to such patients. However,~     lack of donors, surgical complications, rejection, and high cost are it`s serious problems.~     The potential for stem cells to differentiate into hepatocytes cells was recently confirmed.~     Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been~     demonstrated to decrease MELD score and increase serum albumin in 4 of patients with~     decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that~     umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients,~     particularly reducing the decompensated conditions in these patients.~   "
140139|NCT01220479|"~     Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as~     hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these~     conditions lays in childhood. Exercise is known to have a positive influence on bone mineral~     density (BMD) and some impact on cardiovascular disease risk factors in healthy children,~     but little is known about these associations in children with T1DM.~      The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise~     training program on skeletal development in children with T1DM, compared to healthy~     subjects. The second aim is to evaluate whether the program influences also cardiovascular~     diseases risk factors.~      This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy~     children. Both groups are randomly divided (1:1) in an exercise or a control group: 1)~     exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.~      Exercise groups participate to an identical weight-bearing exercise training program 2 x 90~     minutes per week and controls are relatively inactive.~      Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free~     mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood~     lipids.~   "
140140|NCT01220466|"~     The results of this trial will demonstrate that the iDesign System performs as intended and~     is acceptable in a clinical setting.~   "
140141|NCT01220453|"~     The present trial is aimed to document efficacy (bowel cleanliness), acceptance and~     tolerability as well as patient comfort in the use of the new bowel cleansing product~     PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel~     cleanliness, acceptance, tolerability and patient comfort are affected by specific practice~     procedures, changes in dose etc.~   "
140171|NCT01220063|"~     The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4~     fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation~     session).~   "
140236|NCT01219205|"~     Although it is important in the clinical management to classify BRVO into subtypes based on~     the location of the occlusion (major or macular), few studies have provided such~     information[8,9]. The aim of this study was to evaluate the outcome of patients with macular~     edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab~     injection and to determine the concentrations of cytokines in the aqueous humor according to~     the site of the occlusion.~   "
140237|NCT01219192|"~     The purpose of this study is to evaluate the safety and tolerability and determine the~     recommended dosing for the treatment in patients with advanced pancreatic cancer after~     fist-line Gemcitabine treatment failure.~   "
140142|NCT01220440|"~     The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on~     neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD~     within a double-blind cross-over design over six weeks. The assessment of ADHD followed~     formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A~     neuropsychological testbattery and four behavioral questionnaires were selected as efficacy~     variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory~     control, motor activity), Score (auditory attention), Stroop Test (processing speed,~     inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on~     each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed~     by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by~     the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed~     by a parent and a teacher Monday till Friday through every week), Test Performance~     Questionnaire (completed by the child immediately after each of the three test sessions).~      Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will~     provide better results than a trial including only Met. a)Met and Dex are efficient as~     treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to~     Met. b)At an individual level some of the participants will show positive response to one~     type of stimulants and no response, mixed response or adverse response to the other type of~     stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in~     agreement but also add unique information in the assessment of the effect of stimulants.~     d)Qb-test is sensitive and valid as a measure of the effect of stimulants.~   "
140143|NCT01220427|"~     The purpose of this study is to determine whether specific Micro-RNA expression profiles are~     related to Prostate cancer outcome.~   "
140144|NCT01220414|"~     The purpose of this study is to examine opioid and endocannabinoid mechanisms of~     exercise-induced analgesia in men and women.~   "
140145|NCT01220401|"~     The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation~     Therapy (ERRT) has on nightmares and associated problems in veterans.~   "
140146|NCT01220388|"~     Data from the literature and previous in vitro research conducted in the investigators'~     laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid~     secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor~     (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as~     well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels~     will be measured under treatment with aprepitant versus placebo, in both basal conditions~     and after activation of the adrenocortical function by various stimuli, including upright~     posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be~     given two substances (L-lysine and placebo) in a random order during two 13 days periods~     separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4~     receptors in the control of corticosteroid production in normal man.~   "
140147|NCT01220375|"~     High-dose chemotherapy with autologous stem cell support is the current standard procedure~     in the first-line treatment in younger patients with myeloma fit for intensive treatment.~     Current practice in Switzerland for stem cell mobilization is the combination of~     chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with~     melphalan and autologous stem cell transplant. In this trial the intravenous application of~     Plerixafor is being investigated in respect of the capability of the mobilization of stem~     cells from the bone marrow into the peripheral blood. In contrast to the twice daily~     application of G-CSF (eg. Neupogen) for several days, Plerixafor has to be injected just~     one-time.~   "
140148|NCT01220362|"~     Postoperative urinary retention (POUR) is one of the most common complications after surgery~     and neuraxial anesthesia of which the treatment of choice is bladder catheterization 1. It~     has been a common practice to place an indwelling catheter in the bladder in patients~     receiving epidural analgesia and to leave the catheter as long as the epidural analgesia is~     maintained despite a lack of evidence supporting this approach.~      Transurethral catheterization is associated with significant morbidity such as patient~     discomfort, urethral trauma and urinary tract infections (UTI). Prolonged catheterization is~     the primary risk factor for catheter associated UTI (CAUTI), which is one of the most common~     nosocomial infections and can prolong hospitalisation 2. For this reason there is a growing~     focus on limiting the duration of catheterization and finding methods to avoid unnecessary~     catheterization in perioperative medicine 3,4.~      Lower urinary tract function depends on coordinated actions between the detrusor muscle and~     the external urethral sphincter. Motorneurons of both muscles are located in the sacral~     spinal cord between L1 and S4. Most afferent fibers from the bladder enter the sacral cord~     through the pelvic nerve at segments L4-S2.~      Because epidural analgesia can be performed at various levels of the spinal cord, it is~     possible to block only a portion of the spinal cord (segmental blockade). Based on the~     innervation of the bladder and sphincter between L1 and S4 it can be assumed that epidural~     analgesia within segments T4-6 to T10-12 has no or minimal influence on lower urinary tract~     function.~      In a previous study, we found, against our expectations that thoracic epidural analgesia~     (TEA) significantly inhibits the detrusor muscle during voiding, resulting in clinically~     relevant post-void residuals which required monitoring or catheterisation 5. Because the~     study adopted a before-after design, we could not definitively identify the mechanisms~     responsible for this change in bladder function. In particular, we could not determine~     whether TEA per se or surgery was the main cause. Concerning TEA, it remains unclear which~     compounds of the solution, the local anesthetic, the opioid or both are responsible for the~     observed changes in lower urinary tract function.~      The aim of this study is to compare lower urinary tract function before and during TEA with~     two different epidural solutions (group 1: bupivacaine 1.25 mg/ml vs group 2: bupivacaine~     1.25 mg/ml combined with fentanyl 2 µg/ml) within segments T4-6 to T10-12 for postoperative~     pain treatment in patients undergoing lumbotomy for open renal surgery.~      We expect that a better understanding of lower urinary tract function during TEA could lead~     to a more restrictive use of indwelling transurethral catheters perioperatively.~   "
140149|NCT01220349|"~     Despite careful monitoring of patients with diabetes, it is so far difficult to predict the~     occurrence of cardiac events in the evolution. As shown by various studies conducted in~     patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or~     systolic functions using non-invasive investigations such as echocardiography. For 4 years,~     the evaluation technique of myocardial deformations by two-dimensional speckle tracking~     strain by echocardiography is the subject of high hopes in the earlier detection of still~     asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that~     this technique would improve the detection of myocardial contraction abnormalities in~     patients with insulin-dependent diabetes mellitus (IDDM), and would establish their~     association with micro-angiopathy, frequently encountered in these patients.~   "
140150|NCT01220336|"~     Randomized control trial studying the effect of medical assistant health coaching for~     patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary~     care community clinics, Mission Neighborhood Health Center and Southeast Health Center~   "
140151|NCT01220323|"~     In the present study, the investigators intend to investigate whether anodal transcranial~     direct current stimulation (tDCS) may be effective in reducing pain in chronic pain~     patients.~   "
140152|NCT01220310|"~     Doctors and web-based self-management support pilot study will test whether health~     professionals' observation of an online patient workshop on self-management of diabetes and~     participation in structured learning sessions on self-management strategies will change the~     attitudes and confidence of physicians and other health professionals regarding their~     willingness and ability to perform self-management interventions with patients. If this~     pilot suggests that attitudes and confidence levels can change, we hope to launch a larger~     study to examine this method of learning and its effectiveness in more detail.~   "
140154|NCT01220284|"~     Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of~     efficacy, clinically and preclinically proven synergism and only partially overlapping~     toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity~     are among the most used palliative regimens in a variety of solid tumors, including NSCLC,~     breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought~     into clinical development because of the antitumor activity and toxicity comparable to those~     of carboplatin, together with a good acceptability of the oral administration.The recent~     availability of oral formulation of anticancer agents of proven efficacy in some indications~     is likely to become a valid option which could affect clinical daily management. The oral~     administration of vinorelbine and satraplatin might represent a reasonable option of~     palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for~     which a curative treatment can not be provided.~   "
140155|NCT01220271|"~     The purpose of this trial is to show proof of concept that by blocking the Transforming~     Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical~     benefit.~      Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with~     radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive~     radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health~     Organization Grade III and IV).~      Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299~     in combination with standard radiochemotherapy in patients with newly diagnosed~     glioblastoma.~   "
140156|NCT01220258|"~     One objective of this study is to determine the levels of markers of inflammation on the~     eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy~     volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the~     effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins~     and conjunctivae and on signs and symptoms of blepharoconjunctivitis.~   "
140157|NCT01220245|"~     In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be~     compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority~     principle for the patency. Besides equal patency, an improved quality of life is expected.~     Recruitment will take the first two years and patients will be followed during five years.~     Patients with an indication for surgical bypass, classified category 3-6 with a >50%~     stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one~     crural artery should be patent without significant lesions.~   "
140158|NCT01220232|"~     This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male~     and/or female subjects, to estimate the effect of steady state lersivirine on the steady~     state pharmacokinetics of abacavir/lamivudine.~   "
140159|NCT01220219|"~     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of~     two pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
140160|NCT01220206|"~     POMx can be used as a treatment for erectile dysfunction.~   "
140161|NCT01220193|"~     The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular~     conditions to include normal, pathology, post refractive surgery and cataract.~   "
140162|NCT01220180|"~     This study collects post-marketing safety and efficacy surveillance data in real world~     clinical use of pregabalin for its approved indications in Korea.~   "
140163|NCT01220167|"~     The purpose of this study is to compare dosing effect of water on the single dose~     bioavailability of Ondansetron ODFS 8mg (MonoSol Rx, USA) administered with and without~     water to Zofran ODT® 8mg administered without water in healthy male and female adult, human~     study participants under fasting conditions.~        -  To monitor clinical status, adverse events and laboratory investigations, and to assess~          the relative safety and tolerance of the study drug formulations under fasting~          conditions.~        -  To estimate intra-subject coefficients of variation (CV).~   "
140164|NCT01220154|"~     Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous~     paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of~     this regimen in previously untreated patients with advanced ovarian carcinoma.~   "
140165|NCT01220141|"~     This study is conducted in Europe and Asia. The aim of this observational study is to~     monitor antibody formation towards the room temperature stable formulation of NovoSeven®~     (activated recombinant human factor VII).~   "
140166|NCT01220128|"~     The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of~     a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast~     cancer. The treatment will be given before surgery in combination with standard therapy.~   "
140167|NCT01220115|"~     A long term observational study in sickle cell disease will enhance the understanding of the~     disease patterns, current transfusion practices, treatments and outcomes in sickle cell~     disease.~   "
140168|NCT01220102|"~     The purpose of this observational study is to assess the efficacy of Epiduo and patient~     adherence under daily clinical practice conditions in adults and adolescents (12 to 20~     years) with moderate inflammatory acne using this drug first time in topical monotherapy.~   "
140169|NCT01220089|"~     The study has two primary aims. The first aim is to assess the efficacy of adding in-person~     visits to the use of portion-controlled foods for long-term weight loss. The second aim is~     to assess the use of trained lay counselors for the maintenance of weight loss. The primary~     endpoint of the study will be changes in weight. Secondary endpoints will include changes in~     body mass index (BMI), cardiovascular risk factors, health-related quality of life, and~     cost-effectiveness. The addition of in-person visits with the weight loss counselor is~     predicted to lead to greater long-term weight loss than the use of portion-controlled foods~     alone.~   "
140170|NCT01220076|"~     The biological response to treatment with tamoxifen in the preoperative situation is~     studying in this protocol. This study will enrolls patients with non-metastatic breast~     cancer HR +.~      The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy~     of TAM will be studied.~   "
140172|NCT01220050|"~     The risk of fracture for kidney transplant recipients is 4 times higher that of the general~     population. The hyperparathyroidism plays a key role in the maintenance or development of~     post-transplant alterations of bone remodelling.~      Renal transplant patients are at high risk of hyperparathyroidism, largely because of~     long-lasting renal insufficiency before transplant, and of progressive deterioration of~     kidney function because of chronic allograft nephropathy (a disease of proteinuria and~     progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous~     paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster~     and more effective normalization of parathyroid hormone (PTH) levels than calcitriol~     (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum~     calcium and phosphorus levels.~      Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and,~     secondarily, in urinary protein excretion in renal transplant recipients with secondary~     hyperparathyroidism is worth investigating.~   "
140173|NCT01220037|"~     In the present study, the effects of age and dietary intake will be assessed on myocellular~     characteristics during 72 hours after a resistance type exercise session.~   "
140174|NCT01220024|"~     This study will assess pain intensity for the first 72 hrs after after aggravated movement~     (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the~     CollaRx Bupivacaine implant or a plain collagen sponge.~   "
140175|NCT01220011|"~     The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser~     surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an~     international randomized controlled trial. This trial will answer an important question and~     will help in the management and tailoring of surgical indications in stage 1 TTTS.~   "
140176|NCT01219998|"~     Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following~     paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early~     increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several~     studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL~     has not been studied in neonates after open heart surgery, neither has been identified the~     threshold for accurate prediction of severe AKI requiring renal replacement therapy.~      The aim of this observational cohort study is to describe postoperative kinetics of urinary~     NGAL in neonates and to identify the threshold for accurate prediction of severe AKI~     requiring renal replacement therapy in neonates and infants undergoing cardiac surgery~   "
140177|NCT01219985|"~     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer~     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.~     In case of cancer, metabolism is, classically, increased and some hot spots are visible on~     PET images. Because of respiratory motion and because the liver is intrinsically FDG avid,~     some tumours (especially the smallest ones) can be occulted and missed by the clinician.~      The investigators developed a respiratory-gated PET method in order to reduce the motion~     issue. This protocol has been validated on lung pathologies. The investigators designed a~     study to investigate its effect on liver cancer (primary or metastasis) to check if it~     allows the detection of a higher number of tumour lesions.~      To that aim, patients who are planned to undergo a surgical intervention on the liver can be~     proposed to participate this study. After the standard PET acquisition (acquired in~     free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed~     without additional injection. After that, a breath-hold (~10s) CT is performed.~   "
140178|NCT01219972|"~     This is a prognostic study of the late lung complications arising at the patient's having~     received an allograft of hematopoetic stem cells.~   "
140179|NCT01219959|"~     Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal,~     Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous~     Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as~     measured by the magnitude of change from the baseline value in the HbA1c levels.~      Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis~     solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to~     lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic~     events requiring medical intervention, improved metabolic control, nutritional status, and~     Quality of Life.~   "
140180|NCT01219946|"~     Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in~     lung function and increased symptoms such as breathlessness/dyspnoea, cough and~     expectoration.~      Even though subjective in nature, the symptomatology of COPD and mainly that of~     breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking~     into consideration that the symptoms experienced by the patient who suffers from a~     progressive disease such as COPD can only be perceived and interpreted by the patient him-~     or herself, and thus difficult to be quantified, COPD remains a challenge in clinical~     research.~      Therefore, there is a need to carry out qualitative studies that will provide insight into~     the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a~     further mapping of the impact that COPD symptoms' perception has on a patient's life is~     required, as well as of the different pathways through which symptoms' perception is~     interpreted regarding the limitations of daily living activities, and the subsequent impact~     on disease management. The more the physician learns on the embodied experience of COPD, the~     better he/she may assist the patient in achieving optimal COPD management.~      Thus this cross-sectional observational study was designed aiming to obtain these data.~     Specifically, the study aims to evaluate the most frequently used words by the patients and~     the physicians to express the symptoms of COPD as well as the limitation of activities that~     it causes.~   "
140199|NCT01219699|"~     This is a first-in-man trial, in which BYL719 will be administered to adult patients with~     advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease~     has progressed despite standard therapy or for whom no standard therapy exists. A~     combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients~     with locally advanced or metastatic breast cancer whose tumors have an alteration of the~     PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD~     dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have~     the wild type PIK3CA gene~   "
140181|NCT01219933|"~     This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily~     clinical practice and will evaluate the dose reduction of glucocorticoids once low disease~     activity is achieved in patients with rheumatoid arthritis tre ated with GC and background~     RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the~     non-interventional phase, the use of GC in daily clinical Belgian practice will be evaluated~     and described. This period of maximum 6 mont hs will allow those patients to obtain the~     inclusion criteria for the secondary interventional phase. In the interventional phase, a~     systematic GC dose reductio n schedule will be evaluated in patients having achieved low~     disease activity wh ile receiving the same background therapy with RoActemra/Actemra 8~     mg/kg. Methyl prednisolone will be given from a starting dose of >/= 1 mg to </=20 mg orally~     d aily and will be tapered down. The anticipated study duration is up to 13 months~   "
140182|NCT01219920|"~     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic~     agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional~     chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal~     cancer patients.~   "
140183|NCT01219907|"~     RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and~     stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Vaccines made from HER2 peptides may help the body build an effective~     immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and~     cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer.~      PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded~     HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in~     treating patients with HER2-positive stage IV breast cancer.~   "
140184|NCT01219894|"~     Patients who receive drug-coated stents (as opposed to the less frequently used bare metal~     stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or~     Ticlid for one year. These guidelines apply to all patients with drug-coated stents,~     regardless of the type of stent they received. The purpose of these medications is to~     prevent a clot at the stent site when there is poor healing of artery tissues over the~     stent. A clot is a serious concern because it can suddenly block blood flow to the heart and~     cause a heart attack. These medications have been proven to be helpful in stent patients,~     but they do have risks. The common side-effects are related to bleeding which in a few~     patients can be serious. A patient may be at risk for forming a clot if they must put these~     medications on hold for a surgical procedure to reduce the risk of bleeding. Plavix and~     Effient are also expensive for patients who are underinsured or uninsured. There is interest~     is finding a way to show that a patient's stent has healed properly before 12 months and~     that they can safely stop these medications early.~      This study is looking at a way to determine if patients who receive the Endeavor drug-coated~     stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead~     of 12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor~     stent after 3 months.~      A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to~     look at how much a stent has healed. It allows imaging inside a heart artery and the ability~     to see the healing of tissues over the stent.~   "
140185|NCT01219881|"~     This is a single-center, prospective, randomized, double-blind, double-arm trial including~     68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia~     (GA) with intubation through a laryngeal mask airway (LMA) at The Ohio State University~     Medical Center (OSUMC). Double blinding will be based on both the subject and the research~     staff being unaware of which trial arm the subject is randomized into. Eligible subjects~     that provide voluntary and written informed consent will be included in this study.~   "
140186|NCT01219868|"~     The objective of this study is to explore the impact of a physician-nurse team supervising~     patient's flow on ED length of stay~   "
140187|NCT01219855|"~     This study will investigate how the levels of a repeat dose of CTAP101 changes in the body~     over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances~     (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency~     and secondary hyperparathyroidism (SHPT).~   "
140188|NCT01219842|"~     Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent~     claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health~     Technology Assessment Report identified only limited evidence for the effectiveness of~     invasive treatment for IC in patients already on exercise training. The prognosis for the~     extremity is usually benign and treatment therefore aims at improving quality of life.~     Invasive treatment can also cause serious complications. Coronary artery disease is common~     in IC patients increasing the risk with invasive treatment. In spite of these uncertain~     merits and potential risks, invasive procedures for IC are increasing and 37% of all~     invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to~     evaluate the additional effects of modern invasive treatment in patients with intermittent~     claudication receiving modern best medical treatment (BMT). The primary hypothesis in the~     study is that invasive treatment in addition to BMT improves health related quality of life~     and walking performance compared to BMT only.~   "
140189|NCT01219829|"~     The research purpose of this project is to create a registry, and blood and tissue bank for~     individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and~     molecular analysis of resected pancreatic tissue prospectively collected from a cohort of~     pancreatic cancer patients.~   "
140200|NCT01219686|"~     The main purpose of this study is to determine whether the antidepressant response of~     escitalopram 30mg/day or escitalopram 20mg/day + pindolol, a beta blocker, is different~     (faster) compared to a standard dose of escitalopram 20mg/day.~   "
140201|NCT01219673|"~     The goal of this clinical research study is to compare armodafinil, bupropion, and~     minocycline when given alone or in combination. Researchers want to learn about the safety~     and level of effectiveness of these drugs in controlling symptoms, such as the side effects~     of chemoradiation, when given to patients with head and neck cancer.~   "
140202|NCT01219660|"~     To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can~     successfully use APAP following general anesthesia.~   "
140190|NCT01219816|"~     Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal~     prognosis. In this case, allogeneic transplantation is the only curative treatment when~     patient have obtained a second complete remission (CR. In France, in patients younger than~     60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied.~     In older patients (>=60 years)or young patients <= 60 years no eligible for intense~     chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to~     avoid too much toxicity but the result is worse in term of CR.~      More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen~     CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab~     is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey,~     USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including~     15 children, has been published so far reporting the efficacy and the toxicity of~     Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3~     progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were~     observed with acceptable toxicity. Tolerance was acceptable.~      The French GRAALL group proposes to test an age-adapted combination of chemotherapy +~     Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their~     prognosis, in term of CR, survival and of number of patients eligible for allograft.~   "
140191|NCT01219803|"~     Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed~     they had antidiabetic effects on the clinical patients and no obvious toxicity was found.~     The purpose of this study was to evaluate the efficacy and safety of different dosage of Ge~     Gen Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship~     of the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.~   "
140192|NCT01219790|"~     This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high~     dose irradiation (3 Gy x 9) associated with zoledronic acid.~      The administration of zoledronic acid repeat dosages defined under the Authorisation on the~     Market.~      All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at~     least 48 hours apart each, for a treatment to J1, J3 and J5.~   "
140193|NCT01219777|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous~     weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with~     epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive~     neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo~     surgery which will allow an objective measure of response to the above regimen as well as~     assessment of surgical outcomes.~   "
140194|NCT01219764|"~     The proposed study will test the hypothesis that H. pylori can be eradicated successfully~     (>85%) using half-or full-dose concomitant non-bismuth quadruple therapy regimen:~     rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in~     patients with peptic ulcers and H. pylori related gastritis.~      Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be~     enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,~     documenting H.pylori infection, will be randomized into one of two groups: Full dose or half~     dose the concomitant regimen, with 100 patients in each group. Compliance and side effects~     will be assessed, and a urea breath test will be done for all patients after 4 weeks of~     therapy completion to evaluate eradication rates. Success of therapy will be evaluated~     according to intent-to treat and per-protocol analyses.~   "
140195|NCT01219751|"~     To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma~     with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma~   "
140196|NCT01219738|"~     Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma~     membrane-mediated and do not require gene transcription and translation. One of these~     non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular~     smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic~     receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g.~     locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists~     (e.g. inhaled beta-adrenergic agonists).~   "
140197|NCT01219725|"~     The purpose of this study was to examine the effect of 6 months moderate intensity exercise~     training completed three times per week upon traditional and emerging cardiovascular disease~     risk factors in postmenopausal women both with and without type 2 diabetes. These risk~     factors include blood markers associated with increased risk such as cholesterol, insulin,~     glucose and markers of inflammation plus measures of body fat, heart and lung fitness,~     vascular stiffness and vascular function. The study hypothesised that moderate intensity~     exercise training would intervene in the exaggerated risk seen in women following the~     menopause, especially in those with type 2 diabetes.~   "
140198|NCT01219712|"~     Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity~     and mortality (M&M) postoperatively. Several studies including some from the investigators~     department have shown that there is a high risk of cardiovascular complications in this~     group of patients and 3-month mortality is 15-20%. One of the causes of this high M&M is the~     high incidence of cardiac failure associated with an increased NT-proBNP in this group of~     patients. The aim of the present study is to evaluate whether optimization of preoperative~     cardiac function can reduce cardiac M&M postoperatively. Following verbal consent, patients~     with an increased NT-proBNP would be randomized to goal-directed preoperative optimization~     or standard management according to current hospital routines. Following optimization, the~     patients would be transferred to the operating rooms and subsequent management including~     perioperative patient management would be left to the discretion of a specialist~     anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and~     NT-proBNP would be measured in all patients according to the study protocol. In addition,~     major adverse cardiac events would be documented and follow-up would be done by after 30~     days and 3 months postoperatively.~   "
140203|NCT01219647|"~     Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise~     has been shown to improve memory and thinking in persons with diseases such as Alzheimer's.~     This study will investigate whether a program of aerobic exercise can improve memory and~     thinking in persons with MS~   "
140204|NCT01219621|"~     1 Purpose~      In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal~     high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated~     bradycardia, single chamber atrial pacemakers are contraindicated although ventricular~     support is only rarely needed. As a result, these patients are usually exposed to an~     unnecessary high proportion of ventricular pacing due to the programming of the system to~     DDD mode for preventive safety reasons. This drains the pulse generator battery, and more~     importantly has long-term adverse effects on ventricular function in a subset of vulnerable~     patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased~     left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which~     increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related~     adverse events have been highlighted in several large clinical studies. Limiting RV pacing~     in non-dependant patients is therefore desirable.~      The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing~     mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe~     atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the~     spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).~      The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces~     the percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii)~     prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the~     long-term hemodynamic status of implanted patients in comparison to the standard DDD mode,~     set with long AV Delays (DDD Long AVD).~      The scientific soundness lying in this study is a proposal of an optimal programming of~     dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.~   "
140205|NCT01219608|"~     This is a double-blinded placebo-controlled block randomized study in intensive care~     patients comparing enteral glutamine supplementation to placebo. The hypothesis is an~     improvement of clinical and paraclinical outcomes. The primary endpoint is Infection~     Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric~     measures and serum inflammatory mediators will be compared.~   "
140206|NCT01219595|"~     The purpose of the research is to determine if eating sweetened, dried cranberries or~     strawberry fruit pieces will increase the types of different E. coli bacteria in the~     intestines which may reduce the likelihood of a major, or highly harmful urinary type of~     bacteria which cause urinary tract infections in susceptible women.~   "
140207|NCT01219582|"~     An observational and multicenter study to assess the effectiveness and safety of Glucobay®-~     M under daily life treatment of type-2 diabetes patients.The study objectives are to~     investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body~     - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus,~     where investigator feels that addition of Glucobay®-M would be beneficial to patients will~     be included in non- interventional study. The routine investigation suggested by the~     attending physician will be done in diabetic patients. No additional investigation will be~     done for the study purpose. The uncontrolled diabetic patient on existing treatment and~     prescribed Glucobay®-M will be included in study after taking the informed consent. The~     patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving~     at least one tablet will be included in the safety analysis.The study is planned to be~     carried out in 10000 patients from 320-350 trial sites in India.~   "
140208|NCT01219569|"~     This is a study to focus on the feasibility of using a monitor which may signal loss of~     visual function intraoperatively.~   "
140209|NCT01219556|"~     This is post-marketing observational study in which data on safety and effectiveness of~     Xirtam H will be collected from routine clinical practice. The study objectives are to~     investigate the effect of Xirtam-H on blood pressure and achievement of target blood~     pressure as well as safety and satisfaction of treatment. All hypertensive patients (Blood~     pressure > 140/90 mmHg) where investigator feels that addition of Xirtam H would be~     beneficial to patients will be included in non interventional study. The routine~     investigation suggested by the attending physician will be done in patients of hypertension.~     No additional investigation will be done for the study purpose. The patient not controlled~     on existing treatment and prescribed Xirtam H will be included in study after taking the~     informed consent. The patient will be followed up for 2-follow up visit each after 6 weeks.~     The physical examination, routine investigation, blood pressure measures will be done and~     the data will be entered in the CRF as mentioned in CRF in each visit. The study is planned~     to be carried out in 9604 patients from around 300 - 350 trial sites in India.~   "
140210|NCT01219543|"~     This is Phase I, open-label and dose escalation study to evaluate the safety and~     tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A~     and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS~     mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase~     and to evaluate daily and BID dosing.~   "
140211|NCT01219530|"~     To explore the attitudes and reactions of gestational carriers and intended parents though~     their medical, pregnancy and postpartum experiences.~   "
140212|NCT01219517|"~     The purpose of this study is to validate the ability to assess the genetic differences (DNA~     fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells~     so that this technique may be used in the future to confirm markers of reproductive~     competence and improve the efficiency and safety of clinical human in vitro fertilization.~   "
140213|NCT01219504|"~     To assess the impact of embryo biopsy on the reproductive potential of human embryos.~   "
140214|NCT01219491|"~     To identify the characteristics in an egg donor that are important to a recipient and to see~     if those characteristics change over time.~   "
140215|NCT01219478|"~     Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks~     (MRs) in patients without retinal lesion.~      Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs~     of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination,~     optical coherence tomography was performed to measure RT.~   "
140216|NCT01219465|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for initial type 1 diabetes is safe and effective.~   "
140217|NCT01219452|"~     The main aim of the study is to determine whether intramuscular injection of umbilical cord~     mesenchymal stem cells can improve the ventricular function of children with idiopathic~     dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible~     mechanism of the improvement of ventricular function in children with IDCM and 2) to~     evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.~   "
140218|NCT01219439|"~     The researchers propose to investigate the causes, incidence, and time-related events of~     chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility~     drugs utilized, and in vitro laboratory culture conditions.~   "
140219|NCT01219426|"~     This study is divided into two stages. In the first stage, students from the University of~     Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling~     Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference~     tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage,~     consecutive pathological gamblers seeking treatment at the University Hospital of Nantes~     completed the three questionnaires. Only questionnaires from participants who reported~     gambling at least one time in the past year were kept for analyses.Responses of students~     gamblers and pathological gamblers presenting for treatment have been compiled for~     analysis.The main objective of the study is to validate the French adaptations of the GABS~     and the GRCS, and to explore their psychometric properties and structures.~   "
140220|NCT01219413|"~     To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the~     renin inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme~     inhibitor perindopril in patients with non-diabetic chronic renal disease.~   "
140221|NCT01219400|"~     The purpose of this study is to explore whether the novel therapy of type 2 diabetes,~     vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon~     counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes.~     Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter~     hypoglycemia is induced under standardized conditions, and the glucagon response is~     determined, and compared to that after a month of placebo treatment.~   "
140222|NCT01219387|"~     The present study is designed to evaluate the basal serum levels of anti-mullerian hormone~     (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and~     pregnancy rate in women 38 years old or older that are undergoing an IVF cycle.~   "
140223|NCT01219374|"~     To explore the attitudes and reactions of ovum donors prospectively after ovum donation and~     to follow their medical histories.~   "
140224|NCT01219361|"~     Couples who have created excess embryos while undergoing IVF procedures, and who do not wish~     to transfer those embryos or donate them to another couple may donate the extra embryos to~     research. The embryos are then used to develop improved laboratory techniques and conditions~     as well as testing the proficiency of laboratory staff.~   "
140225|NCT01219348|"~     Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the~     adjuvant Montanide, for treatment of patients with locally advanced or metastatic non~     small-cell lung cancer. A first-in-man phase I trial.~      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy~     targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination~     against IDO as a possible anticancer target.~   "
140226|NCT01219335|"~     Use of excess materials generally discarded in the process of undergoing IVF treatment to~     further develop and validate laboratory techniques.~   "
140227|NCT01219322|"~     Extravasation is an unintentional injection or leakage of fluids in the perivascular or~     subcutaneous space. Extravasation can be associated with tissue injury with various level of~     severity and long term consequences. Currently the confirmation of intravenous location of~     the Intravenous (IV) catheter requires close observation of the insertion site with~     sufficient infiltration in the perivascular area to allow detection of swelling,~     discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited.~     IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is~     known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to~     evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of~     an IV line in anesthetized patients.~      Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous~     injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and~     microscopic effects were evaluated and a safe dilution was determined. In the second part of~     the study the investigators will evaluated the efficacy of IV diluted SB to detect the~     proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled.~     Patients all under general anesthesia with standard controlled ventilation via endotracheal~     tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood~     from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume~     equivalent of normal saline will be injected in random order. The data collection will~     include patient's demographics, the presence or absence of an increase in the expired~     end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the~     hemodynamic changes after each injection.~   "
140228|NCT01219309|"~     Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was~     effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in~     children and adolescents.~      Method: Randomized placebo-controlled one-way crossover trial with 75 children and~     adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3~     months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD~     Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom~     severity and impairment.~   "
140229|NCT01219296|"~     Data collection and comparison of relationships between patient demographics, stimulation~     protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and~     embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.~   "
140230|NCT01219283|"~     The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis~     (PGD) increases implantation and delivery rates in couples attempting to conceive through in~     vitro fertilization (IVF).~   "
140231|NCT01219270|"~     Osmolality of contrast media can be resulted in translocational hyponatremia after~     percutaneous coronary intervention.~   "
140232|NCT01219257|"~     Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis,~     arthritis as part of inflammatory bowel disease and reactive arthritis) have axial~     involvement (the spine) as well as peripheral inflammation in joints and entheses (where the~     tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA~     may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus~     it is necessary to have a sensitive method for assessing the response to treatment.~     Ultrasonography (US) is a validated and reliable method for assessing disease activity in~     joints and tendons, and may be used to follow the treatment response.~      The present study will include patients with SpA starting on anti-TNF alpha treatment (as~     first biologic medication or when switching to a new biologic treatment). The study is an~     extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of~     arthritic patients starting disease-modifying treatment). The patients will be examined by~     use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.~      The objectives are to explore US as a method to assess peripheral inflammatory activity for~     evaluation of response to medication as well as to compare the US pathology with clinical~     and laboratory findings.~   "
140238|NCT01219179|"~     The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new~     fluid and electrolyte problems that have not been encountered previously,in particular~     electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium~     value >150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration~     of intravenous fluids(IV)that contain sodium. The current treatment modality for~     hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water~     feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated~     electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease~     elevated electrolytes, there would be less need for large volumes of IVF that contribute to~     the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular~     hemorrhage(IVH)and patent ductus arteriosus(PDA).~      The purpose of this proposed study is to determine whether enteral sterile water feedings is~     effective in decreasing the incidence, duration and severity of hypernatremia in ELBW~     infants.~   "
140239|NCT01219166|"~     Gallbladder management in bariatric surgery is controversially discussed. While some~     surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass~     (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim~     of this study was to evaluate the necessity of prophylactic CCE in patients receiving a~     laparoscopic RYGB.~   "
140240|NCT01219153|"~     The aim of this randomized controlled trial is to compare the efficacy of extended high dose~     letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent~     3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an~     adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian~     response undergoing IVF-ET.~   "
140241|NCT01219140|"~     Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate~     extract capsules will produce statistically significant changes in biomarkers for bone~     resorption and formation when compared to subjects receiving placebo.~   "
140242|NCT01219127|"~     Management of chronic diabetic foot skin ulcers require multidisciplinary approaches~     including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in~     selected cases. The results are inconsistent and irregular, and most studies reported~     unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic~     diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant~     human platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and~     acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed~     results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that~     the beneficial effects of HBO, but none showed universal success. Therefore, the development~     of a new effective method of treatment for chronic diabetic ulcers is extremely valuable.~     Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the~     therapeutic benefits through complex biological pathways including neovascularization and~     tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies~     reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported~     effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of~     treatment. With this background, it appears that ESWT may be effective in the treatment of~     chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT~     in chronic foot ulcers, and to compared with that treated with HBO, and to study the~     molecular and blood flow perfusion before and after ESWT.~   "
140243|NCT01219114|"~     The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions~     of actual use in patients who are diagnosed with complicated Skin and Skin Structure~     infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and~     are prescribed CUBICIN by their physician.~   "
140244|NCT01219101|"~     According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but~     only 30-40% becomes pregnant. The difference has been attributed to a negative action of~     clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial~     receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient~     dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI~     in women who use CC alone and those who use CC in combination with ethinyl estradiol~   "
140245|NCT01219088|"~     Falls are a common problem in elderly patients resulting fractured femur, which require~     early operation. Adequate postoperative pain control will provide good recovery. The~     investigators will compare the efficacy of postoperative pain control among intrathecal~     morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients~     undergone intramedullary hip screw under spinal anesthesia.~   "
140246|NCT01219075|"~     RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use~     of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This~     clinical trial studies soy isoflavones supplementation in treating women at high risk for or~     with breast cancer.~   "
140247|NCT01219062|"~     Falls are a common problem in elderly people which they have to receive the operation.~     Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good~     pain control will provide the good recovery and outcome. The investigators compare the~     efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.)~     with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients~     received hip hemiarthroplasty under spinal anesthesia.~   "
140248|NCT01219049|"~     Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to~     take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out~     questionnaires about their symptoms and see if they have any improvement. The investigators~     hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.~   "
140259|NCT01218906|"~     The purpose of this study is to detect acute febrile episodes and dengue infection in five~     Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure~     at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent~     dengue infection.~      The primary objectives are:~        -  To identify acute febrile episodes among the cohort in order to detect the presence of~          dengue infection.~        -  To develop operational infrastructure for potential Phase III dengue efficacy trial~          sites.~        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of~          the study.~   "
140249|NCT01219036|"~     Asthma usually responds to standard doses of inhaled steroids with or without additional~     therapies to control their symptoms. However, approximately 5-10% do not respond to this~     treatment strategy and are referred to as having difficult asthma. Evidence shows that this~     poor response is not always related to asthma severity with non-adherence to treatment being~     a common underlying problem, in 35% of subjects. Recognising non-adherence in the clinic is~     problematic as there is no straightforward objective test to identify it.~      Patients attending an asthma clinic whose symptoms are not controlled by standard treatment~     will be assessed for airway inflammation using fractional exhaled nitric oxide, and sputum~     analysis. These subjects will be observed taking their medication to determine if this~     reduces their level of airway inflammation. Prescription records will be used to ascertain~     if this test distinguishes those who are non-adherent with their treatment from those adults~     who have severe asthma.~      Identifying patients who are non-adherent to treatment will allow an appropriate change in~     management and enable alternative strategies to be developed to tackle non-adherence in this~     population. Distinguishing patients who are adherent to treatment but have therapy resistant~     disease would significantly improve treatment effectiveness in this group by allowing these~     patients to be suitably targeted with expensive novel therapies such as Omalizumab.~   "
140250|NCT01219023|"~     Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a~     25%-50% of patients treated with several commonly used anti-cancer drugs including~     capecitabine and sunitinib. These drugs are known to improve survival in many cancers,~     including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors~     (GIST). Worldwide, over 400,000 patients per year are treated with one of these agents. HFS~     involves skin changes, such as swelling, peeling, and blistering of the palms and soles,~     which is often painful and debilitating. As a result, HFS-related symptoms can frequently~     lead to dose reduction and/or discontinuation of otherwise effective anti-cancer treatment.~     There is no treatment for HFS other than dose reduction or stopping treatment. This proposal~     could quickly lead to treatments to prevent and/or treat HFS and help patients avoid~     debilitating side effects while continuing otherwise effective treatments for their cancer.~   "
140251|NCT01219010|"~     The purpose of this study is to determine if siltuximab has an effect on the heart function~     measured by ECG recordings and more specifically to determine if siltuximab has an effect on~     the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS),~     Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also~     look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.~   "
140252|NCT01218997|"~     This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of~     repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to~     adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual~     of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1~     ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of~     VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.~   "
140253|NCT01218984|"~     This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults~     to assess the presence, duration, and degree of opiate blockade as well as the safety and~     tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio~     to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or~     300 mg.~   "
140254|NCT01218971|"~     This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base~     study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4~     weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study~     ALK21-003.~   "
140255|NCT01218958|"~     This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study~     conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and~     Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1)~     to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone~     380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg~     (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.~   "
140256|NCT01218945|"~     The repair of large osseous defects remains still unsolved. Aim of this study is to isolate~     and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore,~     our research idea is to pre-engineer large synthetic bone grafts and study the~     vascularization process in vivo.~   "
140257|NCT01218932|"~     This is a standard pharmacokinetic interaction study. Subjects will be randomized to be~     either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each~     hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who~     receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2~     of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1~     week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third~     admission (visit 4) after 8 weeks wash out period.~      Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of~     chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of~     primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week~     wash out period in between.~   "
140258|NCT01218919|"~     The objective of this study is to evaluate the effectiveness of a rechargeable Deep Brain~     Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced,~     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.~      This is the first observational study for the use of the BRIO™ rechargeable constant current~     device, using a lead with an active electrode tip for deep brain stimulation in Parkinson~     subjects. The current study was designed to conform to normal medical practices, taking into~     consideration the current day economic constraints, while assessing the best set of~     circumstances for the successful sustained reduction of some of the symptoms of advanced,~     levodopa-responsive Parkinson's disease that are not adequately controlled with medication.~   "
140334|NCT01217931|"~     The goal of this clinical research study is to compare 6 different 2-drug sequences of~     everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer.~     For the 2-drug sequence, participants will receive 1 of these drugs and may start taking~     another of these drugs after that. Researchers will also study the safety of these 2-drug~     sequences.~   "
140260|NCT01218893|"~     Malaria is one of the major infectious diseases in the world with a tremendous impact on the~     quality of life significantly contributing to the ongoing poverty in endemic countries. It~     causes almost one million deaths per year, the majority of which are children under the age~     of five. The malaria parasite enters the human body through the skin, by the bite of an~     infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the~     hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the~     blood stream, causing the clinical phase of the disease.~      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,~     a protocol has been developed in the past to conduct experimental human malaria infections~     (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the~     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although~     potentially serious or even lethal, P. falciparum malaria can be radically cured at the~     earliest stages of blood infection where risks of complications are virtually absent.~      The investigators have shown previously that healthy human volunteers can be protected from~     a malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito~     bites) under chloroquine prophylaxis (CPS immunization). However, it is unknown how many~     mosquito bites are necessary to confer protection. Moreover, as all volunteers were~     protected in this study, no correlates of protection could be established. For future~     development of vaccines and understanding of protective immunity to malaria, it is important~     to investigate the lowest dose of CPS immunization that confers 100% protection and to find~     correlates of protection. Therefore, the present study aims to make the CPS immunization~     protocol more sensitive by lowering the number of infected mosquito bites, in order to study~     the underlying mechanisms of protection.~   "
140261|NCT01218880|"~     Phase I trail will be conducted to evaluate the safety of M2ES in combination with~     gemcitabine in locally advanced or metastatic pancreatic cancer.~   "
140262|NCT01218867|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for~     treating patients metastatic cancer that involves taking white blood cells from the patient,~     growing them in the laboratory in large numbers, genetically modifying these specific cells~     with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells~     back to the patient. This type of therapy is called gene transfer. In this protocol, we are~     modifying the patient s white blood cells with a retrovirus that has the gene for~     anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus.~      Objectives:~      - To determine a safe number of these cells to infuse and to see the safety and~     effectiveness of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to~     treat recurrent or relapsed cancer.~      Eligibility:~      - Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with metastatic cancer that has not responded to or has relapsed~     after standard treatment.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells.~          {Leukapheresis is a common procedure which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will~          stay in the hospital for about4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up~          to 2 days.~   "
140263|NCT01218854|"~     Background:~      - Currently, standard procedures for biopsies that are guided by computed tomography (CT)~     imaging involve CT scans and a computer program to plan and illustrate where the physician~     will place the needle to obtain the required cells or tissue. Inserting the biopsy needle at~     the planned angle is not an easy task, because the appropriate angle of insertion must be~     estimated based on prior experience. Researchers are studying experimental techniques that~     might provide better guidance about the right angle to insert the biopsy needle and thereby~     improve the collection of the appropriate biopsy cells or tissue.~      Objectives:~      - To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue~     biopsy.~      Eligibility:~      - Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy.~      Design:~        -  Participants will have a tissue biopsy guided by CT scans and either a laser system or~          a plastic block to illustrate the appropriate angle of insertion. The skin will be~          numbed with anesthetic to minimize discomfort during the procedure.~        -  Before inserting the biopsy needle, the study physician will hold the needle in place~          so that a Food and Drug Administration-approved medical GPS (electromagnetic tracking)~          system can measure the needle angle as it enters the tissue.~        -  After the needle angle data has been collected, researchers will proceed with the~          actual biopsy procedure as it would normally occur, using standard methods.~        -  No additional treatment will be provided as part of this protocol.~   "
140264|NCT01218841|"~     Surgical trauma can lead to an intense inflammation and impairment of the capacity to fight~     against infections. Fish oil is composed by substances called omega-3 fatty acids which have~     anti-inflammatory effects. When infused through the vein as part of a nutritional treatment~     of some surgical patients, fish oil have been shown to preserve some defense capabilities~     against infections and to decrease postoperative release of inflammatory substances,~     contributing to the shortening of length of hospital and intensive care unity (ICU) stay and~     complications, mainly infectious complications. These reported benefits have been~     encouraging the vein infusion of fish oil as a kind of medicine to contribute for the~     treatment of surgical patients. In current study the investigators evaluated the effect of~     preoperative infusion of pure fish oil in patients with gastrointestinal cancer (stomach and~     colon) on their clinical outcomes. The hypothesis considered that preoperative infusion of~     fish oil, not as part of nutritional therapy but as a medicine agent, can attenuates~     inflammation and improves the capacity of surgical patients to fight against infections,~     improving their treatment.~   "
140265|NCT01218828|"~     Using a randomized controlled trial design, two hydration protocols for the prevention of~     contrast medium-induced nephropathy will be tested.~   "
140266|NCT01218815|"~     CORAMI trial is a prospective, international, multicenter randomized study which will be~     performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary~     intervention) duty and patient enrollment will continue for 18 months (October 2010 - March~     2012).The aim of the study is to compare strategy of complete vs target lesion-only primary~     PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.~   "
140267|NCT01218802|"~     The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in~     decreasing cardiovascular risk and bone loss in the HIV+ population.~   "
140268|NCT01218789|"~     The purpose of this study is to evaluate the safety of a one year open-label treatment of~     tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.~   "
140269|NCT01218776|"~     The International Registry of Acute Coronary Syndromes registry study in Transitional~     Countries (ISACS-TC) is both a retrospective and prospective study which was designed in~     order to obtain data of patients with acute coronary syndromes in countries with economy in~     transition, and herewith control and optimize internationally guideline recommended~     therapies in these countries Further study details as provided by the CINECA~     http://isacs-ct.cineca.org/~   "
140270|NCT01218763|"~     This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.~      This trial aims to validate the automatic detection features provided by the external~     long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to~     assess the performances of the Mode Switch function provided by Sorin Group Implantable~     Cardioverter-Defibrillators (ICDs).~      This trial is being performed first in order to demonstrate the ventricular tachycardia~     (VT)/ ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of~     the EventScope™ software.~      Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection~     enabled and Mode Switch (MS) algorithms activated in all patients.~      Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.~   "
140271|NCT01218750|"~     The purpose of this study is to evaluate the safety end efficacy of combined~     phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use~     of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the~     possible preoperative and intraoperative factors that might influence surgical outcomes.~   "
140272|NCT01218737|"~     The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin~     and 1.0% prednisolone acetate association in eye drops in the prevention of infection and~     inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of~     the efficacy of this association compared to the administration of 0.3% gatifloxacin and~     1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is~     randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days,~     with 15 days of study treatment administration after the ocular surgery is performed.~     Candidates for the study are patients with indication for ocular refractive surgery (Lasik)~     for correction of visual acuity.~   "
140273|NCT01218724|"~     Objective:~      to compare the single dose bioavailability of Torrent's Losartan Potassium and~     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,~     Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
140274|NCT01218711|"~     Objective:~      to compare the single dose bioavailability of Torrent's Losartan Potassium and~     Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co.,~     Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
140275|NCT01218698|"~     Objective:~      compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg~     and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects~   "
140276|NCT01218685|"~     The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted~     vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised~     disease, elderly and pregnants. The primary immunological endpoint is to analyze the~     proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition~     assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21~     days after vaccination. Volunteers will be recruited based on inclusion and exclusion~     criteria. Vaccine composition is: 15 micrograms of split inactivated virus~     (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is~     safe and immunogenic in the volunteers recruited.~   "
140277|NCT01218672|"~     The study will compare procedural and post procedural outcomes for photoselective~     vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The~     study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE~     marked monopolar or bipolar loop TURP system for the treatment of benign prostatic~     hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to~     TURP.~   "
140278|NCT01218659|"~     Study to compare the efficacy and safety of AT1001 and enzyme replacement therapy (ERT) in~     male and female patients with Fabry disease who are currently receiving ERT and who have~     AT1001-responsive GLA mutations.~   "
140279|NCT01218646|"~     The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the~     licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and~     the investigational TIV containing the alternate B strain in adult subjects.~      Primary Objective:~        -  To demonstrate non-inferiority of antibody responses to QIV compared with licensed~          2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the~          alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the~          four virus strains separately among subjects 65 years of age and older~      Observational Objective:~        -  To describe the safety profiles of TIV among subjects 18 years of age and older and QIV~          in subjects 65 years and older, as assessed by solicited injection site and systemic~          adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events~          collected from 21 days post-vaccination, and adverse events of special interest and~          serious adverse events (SAEs) collected from Visit 1 to Visit 2.~   "
140280|NCT01218633|"~     Multiple studies have examined the effect of endogenous GLP-1 secretions by using a~     competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min.~     However, the presence of an effect does not necessarily imply that this effect is due to the~     blockade of the endogenous GLP-1 actions at the receptor. It is possible that the~     supraphysiologic concentrations of Exendin may have effects of its own. To examine the~     effect of Exendin on glucose metabolism the investigators propose a dose-response study to~     determine whether the compound has effects in a dose-dependent fashion.~   "
140281|NCT01218620|"~     This randomized phase I trial studies the side effects and best dose of RO4929097 in~     treating patients with advanced solid tumors. RO4929097 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
140307|NCT01218282|"~     Exercise training is the key component of respiratory rehabilitation.The success of~     long-term program resides in the integration between exercise prescription and~     patients'compliance with home training. This can be difficult for patients, especially in~     terms of understanding the exercise intensity.~      This study is designed to evaluate different methods of exercise training at home, to help~     understanding and maintaining the walking intensity in COPD patients. Outcome: exercise~     performance, daily physical activity and respiratory function.~   "
140308|NCT01218269|"~     This study will assess the nitinol U-clip as an alternative to conventional microsurgical~     suture for arterial anastomoses in free tissue transfer.~   "
140282|NCT01218607|"~     Volume overload due to left-to-right shunting in patients with atrial septal defect type~     secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular~     resistance can be assessed non-invasively using bicycle stress echocardiography. By~     measuring cardiac output and pulmonary artery pressures at different stages of exercise, a~     pressure-output plot can be obtained. The slope of the pressure-output plot reflects~     pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years,~     pulmonary vascular resistance was higher when compared to age-matched controls, indicating~     the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease~     pulmonary vascular resistance.~      The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD~     repair after the age of 40 years, administration of bosentan decreases pulmonary vascular~     resistance as assessed by bicycle stress echocardiography.~   "
140283|NCT01218594|"~     To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy~     (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).~   "
140284|NCT01218581|"~     To date, there is no uniform agreement on the most appropriate therapeutic methods for~     managing women with uterine adenomyosis and/or adenomyoma who want to preserve their~     fertility. Management with hormonal treatment that aims to reduce the proliferation of~     endometrial cells is promising, but there is a paucity of well-designed studies to guide~     treatment. There is a strong need to develop pharmacological agents that provide an~     efficient outcome. Gonadotripn releasing hormone analogues (GnRHa) have been used in several~     studies, to produce a constant hypoestrogenic state in a woman with adenomyosis which cause~     amenorrhoea, control of pain and uterine shrinkage . Pure antiestrogens, however, may offer~     some advantage in the treatment of adenomyosis and trials are required to assess its~     usefulness. Leiomyoma and uterine volumes were successfully reduced by use of aromatase~     inhibitors (AIs). Assuming aromatase production activity in the adenomyosis lesion, Kimura~     et al, used GnRHa and an AI concomitantly for treatment of uterine adenomyosis. This lack of~     information stimulated us to run this trial to compare the efficacy of aromatase inhibitor~     vs. GnRHa in treating premenopausal women with uterine adenomyosis.~   "
140285|NCT01218568|"~     The study will be double blind with respect to rifaximin, and randomization will be~     performed using tables of computer-generated random numbers. All subjects will be followed~     up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the~     Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided~     doses so that patient passes 2-3 semisoft stools per day along with placebo . In the~     lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three~     times a day along with lactulose. Primary endpoints will be recovery of overt HE patients~     who will not recover from HE after 10 days will be continued on the same treatment. Total~     duration of the study is 1 year.~   "
140286|NCT01218555|"~     The purpose of this study is to study the combination of two anticancer drugs, everolimus~     (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard~     treatment or patients who are unable to tolerate the standard treatment for their cancer.~   "
140287|NCT01218542|"~     Brain metastases are the most common adult intracranial tumor, occurring in approximately~     10% to 30% of adult cancer patients, and represent an important cause of morbidity and~     mortality. The most widely used treatment for patients with multiple brain metastases is~     whole brain radiation therapy (WBRT). The use of WBRT after resection or stereotactic~     radiosurgery (SRS) has been proven to be effective in terms of improving local control of~     brain metastases.~      RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering~     radiation that uses arcs to deliver highly conformal intensity modulated three dimensional~     dose distributions. The purpose of this investigation is to evaluate an alternative strategy~     for giving WBRT with highly focal boost to gross visible lesions in patients with brain~     metastasis.~      Given the limitations of the SRS boost technique, the purpose of our investigation is to~     evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible~     lesions in patients with brain metastasis. In this study, we plan to assess the tolerability~     of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to~     simultaneously treat the entire brain with a concomitant focal boost to grossly identified~     lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.~      This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10~     fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10~     fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one~     of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in~     10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15~     fractions with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A~     total of 12 patients have been previously enrolled on this trial. No patients have~     experienced a dose limiting toxicity (grade 3 or above) at least possibly due to study~     therapy. Also, no patients experienced local brain failure/progression at a site of treated~     metastatic brain disease. Based on this, we no longer feel that dose escalation to the gross~     brain disease is warranted and would proceed with a single arm pilot study treating patients~     with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a~     total of 45 Gy in 10 fractions to gross brain metastatic disease.~   "
140288|NCT01218529|"~     This phase II open-label study will be performed to evaluate the response rate of brain~     metastases from lung and breast tumors under treatment with WBRT and lapatinib.~   "
140289|NCT01218516|"~     The primary objective of this study is to compare the effect of farletuzumab versus placebo~     in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum~     agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on~     investigator-assessed progression free survival (PFS) as determined by Response Evaluation~     Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new~     occurrence of positive fluid cytology) in chemotherapynaive participants with folate~     receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.~   "
140290|NCT01218503|"~     This study is designed to determine whether obese, normal weight, and successful weight loss~     maintainers differ in their food choice decision-making and/or executive function, and~     whether participation in a behavioral weight loss program leads to neural and/or behavioral~     changes. The investigators will examine behavioral performance on several tasks involving~     decision-making and self-control in conjunction with brain imaging data acquired during a~     food-choice decision-making task. Participants enrolled in the behavioral weight loss~     program will also be assessed following the treatment.~   "
140291|NCT01218490|"~     It is a multicenter randomized trial of superior cleaning compared the absence of dissection~     in stage III patients with optimal surgical resection without retroperitoneal lymph node~     palpable.~   "
140292|NCT01218477|"~     The purpose of the study is to determine the safety and tolerability of the combination of~     BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.~   "
140319|NCT01218126|"~     Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of~     losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance.~     Eligible subjects will be randomised to treatment after a one-week run-in period. The~     duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to~     reach the target enrolment of approximately 600 randomised subjects.~   "
140293|NCT01218464|"~     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and~     liver transplantation is the only available therapeutic option for patients suffering with~     this condition. However, lack of donors, surgical complications, rejection, and high cost~     are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells~     (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver~     failure and contribute to liver regeneration. In this study, the patients with LF will~     undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via~     peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for~     these patients.~   "
140294|NCT01218451|"~     The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C~     in infants (at either 4 or 6 months of age), as determined by immune response.~   "
140295|NCT01218438|"~     The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation~     for the treatment of patients with primary immunodeficiency diseases (PIDD).~   "
140296|NCT01218425|"~     A recent study at our lab showed increased episodic memory consolidation and response~     readiness after treatment with methylphenidate in healthy volunteers. The investigators seek~     to replicate and extend these findings. Furthermore the pharmacological specificity of these~     effects will be studied. Since methylphenidate has an effect on two neurotransmitters,~     dopamine and noradrenaline, either could be responsible for the observed effects. In order~     to explore the dopaminergic contribution to this effect, the study proposed here includes~     not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not~     noradrenaline.~      In this study, 20 healthy males and females between 18 and 45 years of age will participate.~     They will be recruited via advertisements at Maastricht University and in local newspapers.~      Participants will be treated once with methylphenidate, once with levodopa/carbidopa and~     once with placebo. All medications will be administered orally with a capsule.~      It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic~     memory consolidation and improve response readiness~   "
140297|NCT01218412|"~     The specific aims of the proposed study are:~        -  1. To determine if web-based Motivational Interviewing (MI) is effective, compared to~          an informational web-based comparison group, in enhancing physical activity (PA)~          participation; and~        -  2. To assess the mechanisms by which web-based MI enhances PA through changes in~          targeted cognitive mediators.~      The specific hypotheses of the study include that:~        -  Hypothesis 1: Web-based MI will increase PA;~        -  Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased~          readiness to participate in PA;~        -  Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;~        -  Hypothesis 4: Cognitive variables will mediate increases in PA participation.~   "
140298|NCT01218399|"~     This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received~     funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with~     Stanford staff. We hypothesize that the budesonide/formoterol combination improves the~     efficacy of budesonide alone.~   "
140299|NCT01218386|"~     The present study is set up to evaluate the efficacy of a programmation by administration of~     estrogen valerate during 6 or more consecutive days. In this prospective randomised trial,~     we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days~     during the luteo-follicular transition period of the menstrual cycle.~   "
140300|NCT01218373|"~     The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term~     effects of continuous assistance offered by the HOMESWEETHOME services to older people~     living independently. The trial will test the hypothesis that while providing a level of~     safety equivalent to or better than that enjoyed in older people‟s homes, there is a~     significant positive effect on the quality of life (QoL) and the duration of independently~     living of older people.~   "
140301|NCT01218360|"~     This is an observational study to determine the prevalence of moderate to severe Crohn's~     disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a~     standard clinical practice.~   "
140302|NCT01218347|"~     This study aimed to explore the influence of organic anion transporting polypeptide1B1~     (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after~     rosuvastatin administration.~   "
140303|NCT01218334|"~     The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical~     trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by~     the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves.~     The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective~     cardiac catheterization or electrophysiology procedures; 2. patients coming for outpatient~     cardiology appointments; 3. Inpatients admitted with a cardiac diagnosis.~      The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain~     the ECG.~   "
140304|NCT01218321|"~     This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid)~     have an effect on the mitochondrial oxidative phosphorylation.~      The objective of this study is to evaluate this effect in an accessible tissue—human~     peripheral white blood cells.~   "
140305|NCT01218308|"~     This study is designed to test the efficacy of an investigational influenza vaccine, in~     children compared to Havrix®, a licensed Hepatitis A virus vaccine.~      This study will also evaluate the immunogenicity and safety of the investigational vaccine.~   "
140306|NCT01218295|"~     Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea~     improves exercise tolerance in healthy subjects. No information is available about the use~     of this training in COPD patients even if other methods (such as threshold loading and~     resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function,~     Health-Related Quality of Life and Exercise Tolerance.~      This study is designed to evaluate the effects of normocapnic hyperventilation by means of~     Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the~     methodology of isocapnic hyperpnoea)in COPD patients.~   "
140320|NCT01218113|"~     This study is designed to determine whether administration of the GSK Biologicals HIV~     vaccine 732462 can lead to a reduction in viral load, and impact on the course of human~     immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet~     started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in~     the initiation of treatment.~   "
140309|NCT01218256|"~     Skeletal muscle accounts for up to 40% of the total body weight and is responsible for~     approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training~     has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore~     the investigators aim to compose the effects of 2 different resistance training protocols in~     combination with aerobic endurance training (AET) on muscle strength, muscle mass and~     glycemic control in type 2 diabetes mellitus patients (T2DM).~      The investigators aim to perform an 8 week randomized controlled training intervention in 32~     T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart~     rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12~     repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT,~     n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood~     analyses, physical work capacity and muscle strength will be measured pre- and~     post-intervention.~   "
140310|NCT01218243|"~     To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There~     are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more~     effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS)~     by 6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine,~     and increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The~     objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by~     comparison with non-acupoint group.~   "
140311|NCT01218230|"~     Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to~     pathologic myopia~   "
140312|NCT01218217|"~     SQ109 was developed with the aim of shortening TB treatment and providing new drugs for~     resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable~     safety profile in first-in-man studies. The objective of this study is to evaluate the~     extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of~     several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly~     diagnosed, uncomplicated, smear positive, pulmonary TB.~   "
140313|NCT01218204|"~     This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken~     alone or when co-dosed with atorvastatin to subjects with dyslipidemia.~   "
140314|NCT01218191|"~     The aim of this study is to describe acute neurocardiogenic injury after subarachnoid~     hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first~     week and the first six months after SAH.~      The study hypothesis is that the evolution of the cardiac disturbances follows the clinical~     evolution.~   "
140315|NCT01218178|"~     Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and~     therapeutic procedures in interventional cardiology, especially in the acute setting of~     primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and~     N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute~     myocardial infarction.~   "
140316|NCT01218165|"~     Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large~     part of the aging process, including immunosenescence, is explained by an imbalance between~     inflammatory and anti-inflammatory networks, wich results in the low grade chronic~     pro-inflammatory status termed inflammaging. It can contribute to a number of age-related~     chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis).~     Prevention or delay in onset of chronic diseases can potentially benefit a large segment of~     the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade~     inflammation through improvement of the gut barrier function and gut microbiota composition~     in elderly people with low-grade inflammation.~   "
140317|NCT01218152|"~     Neurofibromatosis type 1 (NF1) is a frequent autosomal dominant disorder, caused by~     heterozygous mutations of the NF1 tumor suppressor gene (chr.17q11.2). One of the main~     clinical features is the development of benign and malignant tumors. The most common benign~     tumors in these patients are tumors of the peripheral nerve, named neurofibromas. Every NF1~     patient has a life time risk of 8-13% to develop a malignant peripheral nerve sheath tumor~     (MPNST) starting from a pre-existing neurofibroma. MPNSTs lead to a bad prognosis for the~     patient, with an overall five-year survival of less than 25%. Complete resection is the~     standard treatment, but this is often difficult due to the size of the tumors and the~     location on important nerves, moreover the tumor is frequently metastatic at the time of~     diagnosis. For MPNSTs, like for other cancers, the extent and the spread of the disease at~     time of diagnosis is an important factor in determining treatment outcome. In this regard,~     the analysis of tumor derived cell-free circulating DNA in plasma of NF1 patients would open~     up the possibility to diagnose and monitor the development and progression of MPNSTs using a~     small blood sample. In cooperation with P. Schöffski (UZLeuven), we plan to collect blood~     samples from cancer patients to optimize the DNA extraction procedure starting from plasma~     samples. It is known that patients with cancer have a higher amount of free circulating DNA~     in plasma than individuals without cancer and therefore we want to optimize the DNA~     extraction procedure on plasma from patients with cancer. In the meantime, matching MPNST~     and plasma samples from NF1 patients will be collected and sent to us from the University of~     Eppendorf (Victor Mautner) to optimize the array CGH protocol for the detection of copy~     number changes in plasma DNA of NF1 patients with MPNSTs.~   "
140318|NCT01218139|"~     Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by~     heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene~     (chr.17q11.2). One of the clinical features is the development of benign and malignant~     tumors. The most common benign tumors in these patients are tumors of the peripheral nerve~     sheath, named neurofibromas (cutaneous, subcutaneous and plexiform). Every NF1 patient has a~     life time risk of 8 to 13% of developing a malignant peripheral nerve sheath tumor (MPNST)~     out of a pre-existing neurofibroma. In patients with a NF1 microdeletion (5% of NF1~     patients), this risk is even twice as high compared to patients with an intragenic mutation.~     MPNSTs lead to a bad prognosis for the patient, with an overall five-year survival of less~     than 25%. To know more about the development and progression of these tumors, they will be~     screened by microarray comparative genome hybridization (Leuven) and full exome sequencing~     (Leuven). Further experiments will be done in cooperation (bidirectional) with the foreign~     labs of Victor Mautner (Germany), André Bernards (USA), Karen Cichowski (USA) and Yuan Zhu~     (USA).~      For all these experiments, we will make use of tumoral rest material removed from NF1~     patients.~   "
140322|NCT01218087|"~     Many hospitalized infants can develop a flattening of the back or sides of their head. This~     condition develops gradually when an infant's head rests on a firm or semi-firm surface for~     a prolonged period of time. Premature infants are more likely to have a positional head~     shape deformity because they may spend longer periods of time in a crib. Infants~     participating in this study will be randomly assigned to either standard treatment, which is~     a moldable positioner device, or to a cranial cup device and moldable positioner for~     positioning. The purpose of this prospective single-blinded randomized clinical trial will~     be to evaluate the effectiveness of the cranial cup in preventing positional head shape~     deformity in the NICU patient population.~   "
140323|NCT01218074|"~     Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs.~     This is blamed to increase dramatically bleeding and use of allogenic blood transfusions.~     The investigators test the hypothesis that routine use of aggregometry could show~     antiaggregated patient and lead to normalization of platelet function via administration of~     Desmopressin thus limiting bleeding and transfusions.~   "
140324|NCT01218061|"~     The main objective of the study is to follow prospectively a cohort of patients with~     pre-diabetes to understand the pathophysiological mechanisms involved in switching from~     pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in~     this population.~   "
140325|NCT01218048|"~     There are currently no useful tests to identify patients who will respond to cetuximab~     therapy, notably because EGFR levels do not correlate with the clinical responses observed.~     Thus, the investigators are investigating the role of cellular immunity and immune escape~     mechanisms to explain the differential clinical response to cetuximab.~   "
140326|NCT01218035|"~     This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of~     zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal~     female patients.The study population consists of postmenopausal female patients scheduled~     for total hip replacement because of degenerative hip osteoarthritis. The patients will~     receive either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery~     before hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid~     therapy has been shown to promote bone ingrowth into porous implants in pre-clinical models.~     The investigators hypothesis is that zoledronic acid, given as a single intravenous infusion~     after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip~     prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss~     measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of~     the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA~     imaging modality and in a faster functional recovery of the patients.~   "
140327|NCT01218022|"~     Objective:~      The purpose of this study is to compare the single dose bioavailability of Torrent's~     Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck & Co., Inc.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects.~   "
140328|NCT01218009|"~     This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After~     a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol~     or a dummy drug at regular times four times a day. Then for the last nine months of the~     study, all subjects will be given the albuterol dry powder inhaler and will use it only when~     needed to help with breathing problems. Subjects will need to keep a daily diary (both paper~     and electronic) throughout the study recording any inhaler use and health problems. There~     will be visits to the study doctor about once a month for a year. This study is intended to~     show that the albuterol dry powder inhaler works well and is safe for use over a long period~     of time.~   "
140329|NCT01217996|"~     Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated~     rates of working memory impairment. Working memory (WM) is the ability to hold and~     manipulate information online; for example, when an individual mentally rehearses a phone~     number in order to dial it without writing it down. A computer-based working memory~     intervention has been successful in children diagnosed with ADHD and stroke survivors.~     Individuals participating in the intervention showed improvements on working memory measures~     as well as more complex problem solving skills. Neuroimaging (brain scans) conducted before~     and after training showed changes in brain activation suggestive of underlying changes in~     brain systems that support working memory. This study investigates the effectiveness of this~     computer-based working memory intervention for childhood cancer survivors.~   "
140330|NCT01217983|"~     Evaluation of kidney function is critical in cirrhotic patients as there is a clear~     relationship between renal failure and prognosis. The investigators hypothesized that in~     this population new biomarkers of renal function could help in early detection of acute~     renal failure and in discrimination between renal and pre-renal causes. Finally the~     investigators hypothesized that such biomarkers could predict short-term outcome in this~     population.~   "
140331|NCT01217970|"~     This study is designed to collect data to determine whether a medication, ibudilast, is safe~     for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan~     and South Korea, ibudilast has been used safely in humans as a treatment for asthma,~     pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in~     outpatient settings with people who have methamphetamine dependence. This would be the first~     study to collect this information. This study is important because individuals with~     methamphetamine dependence often relapse to meth use, even when in treatment; some number of~     individuals who participate in an outpatient study will relapse to methamphetamine while~     taking ibudilast. It is crucial to know whether there may be interactions between ibudilast~     and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting~     medication candidate for treating methamphetamine dependence. When individuals become~     abstinent from methamphetamine during early recovery, the body starts an inflammatory~     process in neurons, especially glial cells. Glial cells are important in that they provide~     support to the nerve cells that are involved in thought, movement, and other human~     activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other~     nerve cells during early abstinence, which in turn may help individuals feel better and~     think better during treatment.~      The study specific aims are to determine whether ibudilast alters:~        1. blood pressure and heart rate responses to methamphetamine;~        2. the ratings of craving or other drug experiences from methamphetamine;~        3. the reward/reinforcing effects of methamphetamine; and~        4. the metabolism of methamphetamine.~      Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are~     not looking for treatment will complete this study.~   "
140332|NCT01217957|"~     The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum~     tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in~     combination with lenalidomide and low-dose dexamethasone in participants with newly~     diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the~     overall response rate (ORR) and further evaluate the tolerability and toxicity of the~     combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with~     NDMM.~   "
140337|NCT01217892|"~     This study is being carried out to see if dapagliflozin - administered in a daily dose of~     2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin,~     is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin~     alone.~   "
140338|NCT01217879|"~     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to~     investigate the real-life telmisartan treatment tolerability. It is well known and accepted~     that the Real-life setting is much more adequate to reflect the antihypertensive and safety~     properties of the drug in comparison to the organized and scheduled setting of the clinical~     trial. Because there are not much data on the cough in relation to telmisartan, therefore it~     would we worth to observe the cough frequency and general treatment tolerance in patients~     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.~   "
140339|NCT01217866|"~     Retrospective charts review from one surgeon to compare Group A- cases where the~     laparoscopic portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO~     was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.~   "
140340|NCT01217853|"~     A study in which intraocular pressure (IOP) will be monitored over 24 hours using the~     SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle~     glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP~     patterns emerging from SENSIMED Triggerfish and GAT.~   "
140341|NCT01217840|"~     Large studies of children show that over half of the children in the United States of~     America do not have enough vitamin D stored in their bodies. In children who are overweight~     or obese, the percentage of children who do not have enough vitamin D is even higher.~      Vitamin D is essential for the body to maintain normal calcium levels and strong bones.~     Recent research shows that through the actions of inflammatory markers, levels in the blood~     that measure inflammation in the body, vitamin D plays many other important roles in the~     body like helping to regulate the immune system, blood sugar levels, blood pressure, and~     body fat.~      The purpose of this study is to determine the effect of vitamin D supplementation on~     inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like~     to evaluate cardiometabolic risk factors and the correlation between body mass index,~     vitamin D stores and inflammatory cytokines.~      In an observed, randomized controlled trial over 6 months we will provide observed vitamin D~     supplementation or placebo to healthy obese and overweight adolescents and measure changes~     in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that~     administration of vitamin D to these patients will improve their inflammatory profile and~     cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).~   "
140342|NCT01217827|"~     Despite being a proven life-saving intervention in appropriately selected individuals,~     multiple studies continue to demonstrate low implantation of defibrillators in potential~     candidates. Based upon prior research, a major barrier to low utilization is low referral of~     potential candidates by healthcare providers. In this study, via brief clinical reminder~     placed in the electronic medical record, we ask healthcare providers who have not referred~     potential candidates for defibrillator the reasons for this decision and provide them with~     the tools for referral if appropriate.~   "
140343|NCT01217814|"~     Primary Objective:~      - Demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate [MTX] is superior in~     efficacy to placebo for the relief of signs and symptoms of Rheumatoid Arthritis [RA], in~     patients with active RA who have failed up to 2 Tumor Necrosis Factor α [TNF-α] antagonists.~      Secondary Objectives:~        -  Assess the safety of sarilumab;~        -  Document the pharmacokinetic profile of sarilumab.~   "
140344|NCT01217801|"~     The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS~     8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg)~     (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo~     SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female~     adult, human study participants under fed conditions.~      • To monitor clinical status, adverse events, laboratory investigations and to assess~     relative safety and tolerance of ondansetron formulations under fed conditions.~   "
140345|NCT01217788|"~     The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic~     compound, administered intranasally for the management of acute anxiety in patients~     diagnosed with generalized social phobia.~   "
140346|NCT01217775|"~     The objective of this study is to evaluate the effectiveness and safety in double-blind,~     randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray~     for the acute management of cycle related symptoms in women who regularly experience~     premenstrual dysphoric disorder (PMDD).~   "
140347|NCT01217762|"~     The purpose of this study is to evaluate the safety and clinical feasibility of the IRay~     System for the treatment of wet age-related macular degeneration (AMD).~   "
140348|NCT01217749|"~     The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily~     regimen of orally administered PCI-32765 combined with ofatumumab in subjects with~     relapsed/refractory CLL/SLL and related diseases~   "
140349|NCT01217736|"~     The objective of the study is to determine the magnitude of the effect of direct renin~     inhibition by VTP-27999 on renal plasma flow and kidney function.~   "
140350|NCT01217723|"~     This is a randomized trial for patients undergoing hematopoietic progenitor cell~     transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled~     will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50%~     of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known~     to suppress the types of cells that can cause a transplant complication known as chronic~     graft versus host disease (cGVHD). The goal of this trial is to find out if adding~     Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.~   "
140351|NCT01217710|"~     The objective of this project is to validate the proposed smartphone-based activity monitor~     and to test its use for Motivational Interviewing based counseling for physical activity in~     Chronic Obstructive Pulmonary Disease (COPD).~   "
140352|NCT01217697|"~     The purpose of this study is to collect additional safety information on abiraterone acetate~     administered with prednisone to patients with metastatic castration-resistant prostate~     cancer (CRPC).~   "
140353|NCT01217684|"~     The purpose of the present study is to evaluate test-retest reliability of a standard~     protocol on the Biodex dynamometer in older adults.~      In addition, the test-retest reliability and validity of an experimental measure of knee~     extension strength will be assessed in older adults.~   "
140354|NCT01217671|"~     This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study~     evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema~     caused by Alpha-1 Antitrypsin (AAT) deficiency.~   "
140355|NCT01217658|"~     Excessive infant crying (EIC) is likely to increase the risk of child abuse. The~     investigators propose a randomized trial using an intervention based on recommendations of~     Karp. The investigators will systematically identify 170 term infants with EIC and conduct~     assessments in the home at 6-8 weeks age to test the hypothesis that the intervention~     reduces mean infant hours of night-time crying, increases maternal soothing behaviors and~     improves parental anxiety and depression.~   "
140356|NCT01217645|"~     This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a~     single-dose intravenous administration.~   "
140357|NCT01217632|"~     The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver~     fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy~     with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll~     subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who~     are eligible for antiviral therapy.~   "
140358|NCT01217619|"~     This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib~     as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating~     EGFR mutation in exon 19 or 21.~   "
140359|NCT01217606|"~     This study will evaluate the safety and efficacy of Triple Combination Therapy compared with~     Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary~     open-angle glaucoma or ocular hypertension.~   "
140360|NCT01217593|"~     The purpose of this study is to compare ultrasound and predetermined distance techniques for~     finding the paravertebral space to inject the local anesthetic (numbing medicine) when you~     are given anesthesia for surgery. The paravertebral space is located on either side of the~     spinal cord and contains the nerves that provide sensation to the chest wall. The~     predetermined distance technique is a series of measurements taken to determine the location~     of the paravertebral space where the local anesthetic is injected. The ultrasound technique~     uses direct visualization of the local anesthetic being placed in the paravertebral space.~     This type of anesthesia has many benefits including decreasing your pain after breast~     surgery.~   "
140361|NCT01217580|"~     The purpose of this study is to determine if injecting a local anesthetic, or numbing~     medication, above each hip will decrease the amount of narcotic pain medicine that is~     typically required by a patient after a cesarean delivery. Ultrasound pictures will be used~     to guide placement of this injection. Either ropivicaine (a type of numbing medication~     called a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be~     given a button to press when you have pain. When the button is pressed, you will be given a~     small amount of pain medication called hydromorphone through your IV. You will also be given~     a pain medication called ketorolac through your IV every 8 hours for 24 hours after surgery.~   "
140362|NCT01217567|"~     The Purpose of this study is to compare two methods for closure of the skin after caesarean~     section on the same patient; staples and subcuticular sutures. The study is performed on two~     separate groups of patients: 1. Woman having cesarean section for the first time and have~     not previously had abdominal surgery through a lower abdominal transverse incision. 2.~     Woman, who have previously had a caesarean section done. The following parameters are~     registered:~        1. An objective evaluation of the two ends of the scar 6 months postoperatively.~        2. A patient evaluation of the two ends of the scar 6 months postoperatively.~        3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).~        4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months~          postoperatively.~        5. The rate of infection.~   "
140363|NCT01217554|"~     Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern~     society, resulting in substantial costs to society. Factors associated with the development~     of low back pain include poor posture, strenuous work with the body, inadequate non~     ergonomic work and traumas.~      Rotation movement pattern of the lumbar spine in different positions is essential aspect in~     understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a~     dominant factor which could increase the risk LBP and disc prolapse. There is also a decline~     in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral~     position during sitting and standing.~      In addition,lumbar rotation movement patterns differ in population with LBP compared to~     asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent~     coupled movement patterns of lateral bending in the opposite direction at thr upper levels,~     and by lateral bending in tge same direction at the lower levels . while Chronic LBP~     patients exhibit non consistent patterns altered from those of the normal population.~   "
140364|NCT01217541|"~     Dementia is a serious health problem showing an increasing prevalence rate with increasing~     age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing~     home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50%~     of all individuals with dementia at some point in the course of the illness. In addition,~     they have a combination of physical and psychological diseases which necessitates a close~     collaboration between different specialities in medicine and Old Age psychiatry. In~     collaboration with the communalities, our Old Age psychiatry services want to provide a new~     approach to this challenge and validate it on patient and personnel level.~   "
140365|NCT01217528|"~     The purpose of this study is to determine efficacy of a dedicated programming concept for~     avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient~     with primary prevention ICD indication.~   "
140366|NCT01217515|"~     A Phase III, multicentre, randomised, double blind, placebo-controlled study in subjects~     having anal fissure (AF) with AF-related pain. Subjects will undertake a 1-week screening~     period to provide baseline data and for assessment of eligibility. At the Baseline visit~     (Week 0), eligible subjects (having an average Numerical Rating Scale (NRS) score of >4 for~     worst pain associated with or following defaecation) will be randomised on a 1:1:1 basis to~     one of the three treatment groups. Subjects will receive diltiazem hydrochloride 2% cream or~     diltiazem hydrochloride 4% cream or placebo cream. Study treatment will be applied in and~     around the anus, three times daily, for up to 8 weeks. Following the Week 0 Visit, subjects~     will be contacted by telephone during Week 1 to ensure adequate compliance with study~     treatment, to ensure that study drug is being tolerated and that any concomitant medications~     are used at a level consistent with that prior to randomisation. Subjects will return to the~     clinic for safety and efficacy assessments at Weeks 2, 4, and 8 and receive a follow-up~     telephone call at Week 12, following cessation of therapy.~      Concomitant laxatives and stool softeners will be permitted, as needed, during the entire~     study period (screening and treatment) to ensure that constipation or passage of hard stools~     does not confound evaluation or improvement of the condition. Fibre supplements will be~     allowed but should be continued at the baseline level.~      Instructions on the use of the Interactive Voice Response System (IVRS) diary will be issued~     to subjects to record fissure-related pain (NRS) and bowel symptoms daily during the 1-week~     screening period, to confirm eligibility and post-randomisation to record worst anal pain~     associated with or following defaecation (NRS) and daily overall AF-related pain (NRS). A~     record of the number of times the subject has defaecated, laxative and analgesic usage will~     also be made as well as the number of applications of study treatment, any changes to~     concurrent medications and any Adverse Events (AEs).~      In addition, at some or all study visits, subjects will record the Patient's Global~     Impression of Improvement (PGI-I) on a 7 point Likert scale, complete a Short Form 36~     (SF-36) quality of life questionnaire and will undergo examination of their AF. Routine~     blood samples will be taken and the Skin Irritation Score (SIS) recorded for safety~     evaluations.~      Subjects may receive permitted medications for pain per Entry Criteria, but these should~     remain stable, where possible, up to the Week 8 Visit. Introduction of any new medication~     for AF will not be permitted unless the Investigator deems rescue intervention necessary.~     A subject will be deemed a treatment failure if rescue intervention is required and will~     have to be withdrawn from the study.~      Any subject leaving the study following randomisation for any reason will be asked to~     complete the Early Withdrawal Visit. This includes subjects who withdraw due to the~     development of AEs or intolerance, as well as subjects who require rescue intervention.~     These subjects will return for safety follow-up visits at their previously scheduled~     follow-up assessment appointments. If complete healing has occurred at the 2 or 4 Week~     visits, (i.e. prior to the end of the 8-week treatment period), subjects will be asked to~     continue applying the medication for the full 8 week course, up to the final assessment.~      Following the Week 8 visit (or Early Withdrawal Visit), subjects will be followed up for a~     further 4 weeks (following cessation of study medication) to note any AEs.~      All routine blood analyses (haematology and biochemistry) and plasma levels of diltiazem and~     of its principal metabolites will be analysed by central laboratories.~   "
140367|NCT01217502|"~     This study aims to determine the effectiveness of a self-management program for elderly with~     an acquired and concurrent hearing and visual impairment due to age-related disease~     processes.~   "
140368|NCT01217489|"~     The Signascan Electrical Impedance Mammography (EIM) Study is a pilot study of a~     non-invasive medical device - a novel approach to breast cancer detection using Electrical~     Impedance Mammography (passing minute electrical currents through the tissues and detecting~     the changes to the currents as a result of the tissues, which can differentiate between~     normal and malignant tissue). The trial is a prospective trial of diagnostic capability of~     the device, as compared with standard care (diagnosis provided by the concurrent NHS~     investigation - imaging, surgery etc) performed for female patients attending the~     symptomatic breast clinic for investigation. The aim is to assess the diagnostic efficacy in~     detecting 100 true malignancies, and continue to recruit until 300 patients with true~     malignancies have been recruited if necessary.~   "
140369|NCT01217476|"~     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development~     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken~     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit~     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent~     for solution and a spray part to fit the glass bottle after reconstitution of the final~     product.~      We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group,~     multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w)~     and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a~     superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a~     maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with~     placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients~     will be randomized and it is planned that this study will be conducted at approximately 40~     investigational sites in Europe.~   "
140370|NCT01217463|"~     Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development~     code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken~     Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit~     consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent~     for solution and a spray part to fit the glass bottle after reconstitution of the final~     product.~      The investigators conduct a multinational, randomized, double-blind, placebo controlled,~     parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment~     phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to~     demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic~     origin after 12 weeks topical daily application of trafermin 0.01% spray compared with~     placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients~     will be randomized and it is planned that this study will be conducted at approximately 30~     investigational sites in an estimated 4 countries in Europe (Czech~     Republic,France,Hungary,Italy,).~   "
140371|NCT01217450|"~     This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244~     when given together with cetuximab in patients with advanced or refractory solid tumors that~     cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor~     cells.~   "
140372|NCT01217437|"~     This randomized phase II trial studies how well giving temozolomide and irinotecan~     hydrochloride together with or without bevacizumab works in treating young patients with~     recurrent or refractory medulloblastoma or central nervous system (CNS) primitive~     neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. It is not yet known whether temozolomide and~     irinotecan hydrochloride are more effective with or without bevacizumab in treating~     medulloblastoma or CNS primitive neuroectodermal tumors.~   "
140373|NCT01217424|"~     RATIONALE: Reflexology and aromatherapy massage may lessen symptoms in patients with cancer.~     It is not yet known whether reflexology is more effective than aromatherapy massage in~     relieving symptoms in patients with cancer.~      PURPOSE: This randomized clinical trial is studying reflexology to see how well it works~     compared with aromatherapy massage in relieving symptoms in patients with cancer.~   "
140374|NCT01217411|"~     This randomized phase I/II trial studies the side effects and the best dose of RO4929097~     (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with~     whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works~     compared to whole-brain radiation therapy or stereotactic radiosurgery alone in treating~     patients with breast cancer or other cancers (such as lung cancer or melanoma) that have~     spread to the brain. RO4929097 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Whole-brain radiation therapy uses high energy x-rays~     deliver radiation to the entire brain to treat tumors that can and cannot be seen.~     Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less~     damage to normal tissue. It is not yet known whether giving RO4929097 together with~     whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.~   "
140375|NCT01217398|"~     RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor cells to grow and spread. Others find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving temozolomide together with~     bevacizumab may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to~     see how well they work in treating patients with metastatic melanoma of the eye.~   "
140376|NCT01217385|"~     RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help~     measure a patient's response and allow doctors to plan better treatment.~      PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and~     predicting response in patients with locally advanced breast cancer undergoing chemotherapy~     before surgery.~   "
140377|NCT01217372|"~     Calcium oxalate nephrolithiasis is a relatively common disease. The prevalence in the~     general population may range from 10 to 12 percent, and 0.4 to 1 percent of new cases are~     reported every year according to different series. Without specific pharmacological therapy,~     the recurrence rate in patient with established diagnosis of nephrolithiasis is extremely~     high and may range from 15 to 20 percent per year, with a cumulative incidence at five years~     ranging from 27 to 50 percent.Although genetic factors play an important role in the~     development of nephrolithiasis, environmental factors such as diet also appear to affect~     stone formation. Potassium citrate is also effective in preventing stone recurrence in~     patients with calcium oxalate nephrolithiasis. Low tolerability, however, may remarkably~     limit the use of these medication. Citrus fruits are a natural rich source of citrate and~     diet supplementation with juice of citrus fruits may represent a valuable alternative option~     to supply citrate without exposing the patients to the adverse effects of citrate containing~     medications. Among the most commonly consumed citrus fruits, lemons contain the greatest~     concentrations of citric acid (49,2 g/Kg);a half cup of pure lemon juice can provide a daily~     amount of citrate comparable to that of a standard daily dose of alkali citrate medications.~      A few studies tried to evaluate the effects of lemon juice supplementation in patients with~     calcium oxalate nephrolithiasis, but the findings were flawed by the retrospective,~     observational design of the study or by the too small sample size that limited the power of~     statistical analyses and the reliability of the results. This study will be primarily aimed~     at evaluating whether lemon juice added to standard diet recommendations compared to diet~     recommendations alone may reduce the risk of new stone formation in patients with recurrent~     idiopathic calcium oxalate nephrolithiasis. Secondarily, the study will evaluate the effects~     of lemon juice supplementation on complications of nephrolithiasis such as urinary tract~     infections, colic symptoms, and hospitalizations for stone disruption or removal, as well as~     the effects on urinary factors (such as urinary citrate, oxalate, calcium excretion or pH)~     that may favor or limit stone formations and the relationships between these effects and the~     risk of stone recurrence.~   "
140378|NCT01217359|"~     Purpose:~      The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine~     differences in the intracellular actions of interferon or interferon stimulated genes among~     people with different treatment outcomes to interferon based therapy for hepatitis C (HCV).~     Participants: Patients with genotype 1 HCV who have had interferon based therapy at the~     University of North Carolina (UNC). Procedures: Thirty patients with varied responses to~     treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the~     injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn~     for analysis of phosphoprotein profiling and changes in serum cytokines.~   "
140379|NCT01217346|"~     Cardiac syndrome X consists of a triad of chest pain, abnormal exercise stress testing and~     normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction.~     Endothelial dysfunction is also reported to be linked to obstructive sleep apnea. While~     chest pain can be one of potential presenting symptoms of obstructive sleep apnea, the~     investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac~     syndrome X.~   "
140380|NCT01217333|"~     The investigators community based resource center has implemented visit preparation by~     prompting patients to write down their questions. This is a proven approach to increasing~     the number of questions and concerns that patients voice during their visits with doctors.~     The resource center's usual practice is to provide their visit preparation intervention,~     called Consultation Planning, through in-person counseling sessions. This study asks whether~     telephone delivery of Consultation Planning would be almost as effective in terms of~     increasing patient's decision self-efficacy, or confidence in their ability to navigate~     decisions effectively with their physicians. The study also asks about the~     cost-effectiveness of telephone delivery compared to in-person delivery. The investigators~     are answering these questions through a randomized, controlled, non-inferiority trial with~     two arms: in-person versus telephone delivery of Consultation Planning. The investigators~     are measuring self-reported psychological outcomes such as decision self-efficacy (primary~     outcome), preparation for decision making, anxiety, and distress, along with economic~     outcomes such as health resource utilization and willingness to pay. The investigators~     hypothesize that Tele-CP can be delivered at a lower patient and resource center cost than~     in-person CP, and that it will be as effective in terms of impact on a patient's decisional~     self-efficacy.~   "
140381|NCT01217320|"~     Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in~     healthy and elderly people. The investigators speculate that creatine supplementation could~     have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus~     and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting~     and bone mass loss.~   "
140382|NCT01217307|"~     The investigators will evaluate the effect of metformin therapy during 4 months in~     non-diabetic patients following ST-elevation myocardial infarction on left ventricular~     ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.~   "
140383|NCT01217294|"~     Pain control after hip replacement surgery is important to ensure patient comfort, allow~     mobilisation, and aid recovery. The investigators propose a simple and pragmatic study~     comparing two different anaesthetic techniques in the provision of pain relief after hip~     surgery. Patients will be randomised to receive either spinal anaesthesia containing~     morphine or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve~     block. Although morphine is an effective pain killer, its side effects include itch, urinary~     retention, nausea and potentially fatal breathing problems. If the nerve block can be shown~     to provide comparable pain relief to spinal morphine, then morphine could be removed from~     the spinal injection. This could reduce side effects and improve patient safety. The~     investigators wish to investigate whether ultrasound guided fascia iliaca plane block~     provides analgesia which is comparable to that of intrathecal opioid for primary hip~     arthroplasty in the first 24 hours after hip replacement surgery~   "
140384|NCT01217281|"~     Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of~     entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely~     affecting the function of kidneys. This is turn can aggravate the condition of patients with~     CKD.~      The study hypothesis is that periodontal therapy can improve renal function in patients with~     CKD and lower the blood levels of markers for systemic inflammation.~   "
140385|NCT01217268|"~     The investigators want to evaluate the use of video-conference in the collaboration between~     the investigators psychogeriatric department and nursing homes. The study aim is to give~     supervision on a regular basis to the caregivers on a special care unit for patients with~     dementia with behavioural disturbances during a period of half a year. The investigators~     want to investigate the impact on caregivers and patients by applying certain tests at~     baseline, during the intervention and half a year after the intervention.~   "
140495|NCT01215825|"~     It is well established that steroid use is a benefit in the treatment of chronic obstructive~     pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the~     regimen and dosage of steroid use. From this retrospective review of medical charts, the~     researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.~   "
140386|NCT01217255|"~     Because of high cost, persons with hemophilia in many developing countries cannot afford~     adequate treatment. For example, many persons with hemophilia in India and China are only~     rarely treated with factor replacement in response to bleeds, and as a result many have~     developed significant arthropathy and disability. A pilot study in China estimated the mean~     Hemophilia Joint Health Score (HJHS) at 13.1 (SD 9.03) suggesting that these children had~     highly prevalent, severe joint disease. The lack of relationship between the HJHS and~     treatment history suggests overall inadequate therapy.~      The proposed study will quantify the burden of arthropathy, physical disability, and quality~     of life (QoL) in boys with hemophilia in Brazil - where comprehensive treatment is just~     beginning to be widely available. This study will also provide an opportunity to compare~     these outcomes to those observed in Canada, where the dominant therapy has become life-long~     prophylaxis.~   "
140387|NCT01217242|"~     The investigators would like to understand how the physical activity levels and body size of~     a child with cerebral palsy (CP) in a clinical situations versus out in the community~     relates to what they want to do in day to day life (participation in life). The~     investigators believe that what a child really does out in day to day life will predict life~     participation to a greater degree than what they do in a structured clinical situation (i.e.~     therapy session with therapist). The investigators think that increased body size with~     normal growth is related to less physical activity and participation in day to day life for~     children with cerebral palsy (CP) who can walk. This project will use a novel accelerometer~     to measure walking activity during day to day life.~   "
140388|NCT01217229|"~     PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary~     objective of this study is to evaluate the efficacy, as measured by overall response rate,~     of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin~     lymphoma (HL). Secondary objectives include safety, the duration of response, the disease~     control rate, progression free survival, and how the drug affects your body.~   "
140389|NCT01217216|"~     To test the effectiveness and feasibility of intensive motivational, behavior modifying~     intervention aimed at improving physical activity and dietary habits to produce at least 7%~     weight loss in women with a history of breast cancer in a community health setting.~   "
140390|NCT01217203|"~     The primary objective of the clinical study is to evaluate, in patients who experience a~     first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101~     combined with lenalidomide~   "
140391|NCT01217190|"~     The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF~     8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg)~     (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo~     SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female~     adult, human study participants under fasting conditions.~      • To monitor clinical status, adverse events, laboratory investigations and to assess~     relative safety and tolerance of ondansetron formulations under fasting conditions.~   "
140392|NCT01217177|"~     The cervix cancer is the second malignant neoplasia more common between women. The combined~     treatment involving chemotherapy and radiotherapy was defined as the standard. This study~     will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in~     association with cisplatin and pelvic radiotherapy, in patients with squamous cells~     carcinoma of uterine cervix, in stages IIB and IIIB.~   "
140393|NCT01217164|"~     Adequate nutrition is important for preventing malnutrition in the postnatal period and thus~     optimize growth and development of children born prematurely. To avoid malnutrition is~     recommended to provide nutrients necessary for a growth rate similar to the intrauterine~     life.~      For nearly one decade studying how to minimize in-hospital malnutrition in children born~     prematurely, especially with gestational age less than 32 weeks or with birth weight below~     1,500 g, called newborn very low birth weight (VLBW).~      Embleton et al.demonstrated that with the current nutritional recommendations (protein~     between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie~     cumulative deficit.~      Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive~     development after hospital discharge.~      The investigators hypothesis is that VLBW subjected to aggressive nutrition with~     protein-calorie high from birth until discharge, would present higher weight gain than the~     VLBW infants who received routine diet of service, without producing adverse effects.~   "
140394|NCT01217151|"~     In the last years, there is a growing interest in the improvement of prognosis and~     shortening of hospital length of stay in high-risk surgical patients. Several evidence-based~     protocols (fast-track surgery) have been developed and implemented in some hospitals for~     this purpose. Cardiovascular optimization through the so-called goal-directed therapy~     (GDT) is a key element in these protocols. Previous studies in the literature use invasive~     monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several~     clinical scenarios. The aim of the present randomized, international, multi-center,~     open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive~     drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean~     arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms~     of reduction in the incidence of perioperative complications and length of hospital stay in~     high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24~     hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks~     and mortality will be analysed. All patients will be followed from the day of surgery up to~     hospital discharge (determined by a specialist surgeon not involved in the study) or death.~   "
140395|NCT01217138|"~     Part of the problems related with proper use of epinephrine autoinjector may be related with~     the design of the autoinjector itself.The aim of the study is to investigate whether minor~     modifications in the design of currently available epinephrine autoinjector ease its use and~     abrogate common use errors.~   "
140396|NCT01217125|"~     The purpose of this study is to determine whether rapamycin is safe and effective in the~     treatment of renal angiomyolipomas in patients with tuberousclerosis.~   "
140413|NCT01216891|"~     This study will assess the effectiveness of an experimental treatment intervention for~     adolescents and adults who have experienced their first episode of psychosis during the past~     two years.~      The DUP sub-study will collect pathways to care information that will be used to inform the~     development and pilot testing of strategies that aim to reduce DUP among individuals~     experiencing a first episode of psychosis.~   "
140397|NCT01217112|"~     This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to~     determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in~     combination in patients with Type 2 diabetes. This is the first study to determine whether~     the study medications have a positive benefit for subjects on their cholesterol levels, body~     weight, liver fat content and other metabolic parameters compared with a placebo medication.~   "
140398|NCT01217099|"~     The purpose of this study is planned to investigate whether small doses of~     methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than~     macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .~   "
140399|NCT01217086|"~     This is the trial to see how our product is similar to remicade by comparing the results of~     blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or~     parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving~     adequate response to methotrexate alone up to week 30.~   "
140400|NCT01217073|"~     The purpose of this study is to assess the hypothesis that treatment with study medication~     (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic~     severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5~     different doses of omarigliptin to identify which dose is the most effective in the~     treatment of type 2 diabetes.~   "
140401|NCT01217060|"~     The goal of this clinical research study is to learn if giving chemotherapy and radiation~     therapy before surgery for early-stage esophageal cancer can help to control the disease and~     if so, for how long. The safety of this treatment will also be studied.~   "
140402|NCT01217047|"~     This research is being done to study the effect of Functional Electrical Stimulation (FES)~     cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).~   "
140403|NCT01217034|"~     The purpose of this study is to evaluate the safety and efficacy of the combination therapy~     with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in~     patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for~     surgical resection or percutaneous ablation therapy.~   "
140404|NCT01217021|"~     This research will look at how the brain may change in people with Alzheimer disease (AD).~      The purpose of this research is to find out whether changes in the brain in people with~     Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer~     disease have changes in the brain that result in deposits of a protein called beta-amyloid.~     In this study, the investigators will be using a radioactive drug, [18F]MNI-558 that binds~     to beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain~     imaging using PET (positron emission tomography) will be done to see if the investigators~     can evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The~     investigators will compare these scans with those done in healthy normal volunteers. PET is~     a brain-scanning test used in medicine and scientific research to see how the brain is~     working. The PET imaging test used in this study is not being done for diagnostic purposes.~   "
140405|NCT01217008|"~     The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single~     time-point between 7 and 14 days post injury, inclusive, to patients with neurologically~     complete spinal cord injuries (SCI).~   "
140406|NCT01216995|"~     Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs~     delivered via the intracoronary route in the treatment of patients with ST-elevation acute~     myocardial infarction (STEMI).~   "
140407|NCT01216982|"~     Stress-related disorders are among the most prevalent and expensive medical consequences of~     participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are~     known to benefit both neuronal development in the young, and cognition and mood in various~     populations.~      It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher~     cognitive performance, better affect/mood state, and less combat stress symptomatology~     compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the~     prevalence of combat stress injuries in military personnel.~   "
140408|NCT01216956|"~     Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia.~     Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c)~     but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the~     drug has been used for so long, its precise mechanism of action remains elusive. The aim of~     this study was to characterise the metabolic changes induced by 8 week treatment with Niacin~     in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the~     overall lipid effects of niacin will be studied. In order to get a very comprehensive view~     of all metabolic activities of niacin, this study will investigate the potential effects of~     niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in~     lipoproteins and key enzymes involved in lipid metabolism.~   "
140409|NCT01216943|"~     This study will investigate the safety and efficacy of Triple Combination Therapy~     (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients~     with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on~     brimonidine/timolol ophthalmic solution.~   "
140410|NCT01216930|"~     A clinically applicably strategy for molecular screening for Lynch Syndrome has been~     implemented in the Region of Southern Denmark.~      Based on sequential analysis with immunohistochemistry and methylation analysis, patients~     with possible hereditary colorectal cancer are identified. These patients are offered~     genetic risk assessment and counselling.~      The study hypothesis is that molecular screening will identify more patients with Lynch~     Syndrome than the family history alone.~      Prospective data collection is performed using established clinical databases.~   "
140411|NCT01216917|"~     The purpose of the present study is to evaluate the influence of the ageing process on~     muscle quality. Therefore, muscle mass, muscle density and force-velocity characteristics~     are measured after a 5-yr interval in older adults (65+).~   "
140412|NCT01216904|"~     The specific aims of this study are to examine whether treatment with transdermal nicotine~     improves computer-based laboratory and clinical measures of impulsive and compulsive~     behaviors in Parkinson's Disease subjects who have recently experienced an impulse control~     disorder.~   "
140414|NCT01216878|"~     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet~     under fasted conditions.~   "
140415|NCT01216865|"~     The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of~     treatment for diabetic foot is safe and effective in the management of diabetic foot~     ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in~     ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and~     relieve the Sevier pain of ischemia.~   "
140416|NCT01216852|"~     The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet~     under fasted conditions.~   "
140417|NCT01216839|"~     The purpose of this study is to determine the Everolimus aim response in children and~     adolescents with refractory or relapsed Rhabdomyosarcoma and other soft tissue sarcomas~   "
140418|NCT01216826|"~     The purpose of this study is to determine the Everolimus aim response in children and~     adolescents with refractory or relapsed osteosarcoma.~      The aim response is defined as complete or partial response (according to RECIST criteria)~     for at least 4 weeks, or stable disease for at least 12 weeks.~   "
140419|NCT01216813|"~     RATIONALE: Gathering information from patients who have undergone treatment for upper~     gastrointestinal cancer or gynecological cancer may help doctors learn more about patients'~     physical and psychosocial rehabilitation needs and plan the best treatment.~      PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs~     of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological~     cancer.~   "
140420|NCT01216800|"~     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized~     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more~     tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery~     may kill any tumor cells that remain after surgery. It is not yet known whether~     intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more~     effective in decreasing hearing loss in patients undergoing radiation therapy for parotid~     gland cancer.~      PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy~     to see how well it works compared with 3-dimensional conformal radiation therapy in~     decreasing hearing loss in patients who have undergone surgery for parotid tumors.~   "
140421|NCT01216787|"~     This pilot phase II trial is studying how well RO4929097 works in treating patients with~     stage III, or stage IV melanoma that can be removed by surgery. RO4929097 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth~   "
140422|NCT01216774|"~     The purpose of this study is to compare the impact of different levels of mechanical stress~     and muscle fatigue in strength training conditions on muscle strength, muscle mass and~     inflammatory processes.~   "
140423|NCT01216761|"~     Background: Contaminated blood cultures result in unnecessary antibiotic use, increased~     length of stay, and additional laboratory tests, all of which increase healthcare costs.~     While the optimal skin antisepsis agent for reducing blood culture contamination is not~     known, the cost of various agents differs substantially.~      Objective: To determine the relative rates of blood culture contamination for 3 skin~     antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture~     (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated~     phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical~     patients.~   "
140424|NCT01216748|"~     The purpose of this study was to determine if airway pH has an effect on albuterol-induced~     vasodilation in the airway. Methods: Ten healthy volunteers performed the following~     respiratory maneuvers: quiet breathing, hypocapnic hyperventilation, hypercapnic~     hyperventilation, and eucapnic hyperventilation~   "
140425|NCT01216735|"~     The hypothesis underlying the proposed study is that the blunted endothelium-dependent~     vasodilation seen in the airway of current smokers is also present in the brachial artery,~     and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial~     function in the airway of current smokers will also restore endothelium-dependent relaxation~     in the brachial artery. Non-smokers will be used as controls and will not receive any~     intervention or treatment.~   "
140426|NCT01216722|"~     Resistance strengthening exercise will increase strength and functional activity greater~     than ambulation in subjects post-liver transplantation.~   "
140427|NCT01216709|"~     Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with~     cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant~     foods are recommended for infants. However, the optimal iron dose and mode of delivery have~     not yet been established. This is a concern as excessive iron intake may impair growth and~     increase morbidity in iron-sufficient infants. Previous studies have suggested that~     iron-fortified foods may have different effects than iron supplements. In this study, the~     investigators will investigate whether the mode of iron administration (supplementation vs.~     fortification) and the amount consumed (high intakes vs. low intakes) affect iron~     absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient~     6-month-old infants.~   "
140428|NCT01216696|"~     This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous~     preexisting immune response to NY-ESO-1.~      Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in~     patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit~     from an anti CTLA-4 treatment.~      Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction~     period, followed by a radiological assessment in week 12. Patients with clinical benefit~     (partial response, complete response or stable disease according to the immune-related~     response criteria) will continue with an ipilimumab administration every 3 months starting~     at week 24 up to week 48 until the end of the study or until disease progression,toxicities~     requiring discontinuation~   "
140449|NCT01216423|"~     The cause of ischemic stroke remains frequently unknown. In patients with patent foramen~     ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that~     the main mechanism is paradoxical embolism and decided to look for clinically apparent and~     silent cerebral embolism in patients with a recent pulmonary embolism.~   "
140450|NCT01216410|"~     The study investigates the incidence of intraoperative nausea and vomiting under spinal~     anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.~   "
140451|NCT01216397|"~     The objective of the current study is to investigate the relative bioavailability of two~     different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet~     (FDC).~   "
140429|NCT01216683|"~     RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different~     ways to stop the growth of cancer cells, either by killing the cells or by stopping them~     from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in~     different ways. Some block the ability of cancer cells to grow and spread. Others find~     cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different~     ways and stop cancer cells from growing. It is not yet known whether giving bendamustine~     hydrochloride and rituximab together alone is more effective than giving bendamustine~     hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular~     lymphoma.~      PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and~     rituximab together with or without bortezomib followed by rituximab with or without~     lenalidomide to see how well they work in treating patients with high-risk stage II, stage~     III, or stage IV follicular lymphoma.~   "
140430|NCT01216670|"~     The CARRYING ON for heart failure (HF) study is a national, prospective, post market~     interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess~     a short term and a long term period, incidence of pre-specified clinical and arrhythmic~     events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac~     decompensation.~   "
140431|NCT01216657|"~     Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor~     effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib~     and data about angiogenesis and growth regulation in melanoma suggest the activity of~     Sunitinib in melanoma. This study will investigate the efficacy, safety and tolerability of~     Sunitinib as palliative treatment in chemo-refractory metastatic melanoma.~   "
140432|NCT01216644|"~     Patients with locally advanced resectable adenocarcinoma of the stomach or the~     esophagogastreal junction without previous therapy will be treated with one of two~     chemotherapy combinations before and after surgery. One half of the patients gets~     5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin,~     Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.~   "
140433|NCT01216631|"~     The aim of this study is to establish the efficacy and duration of effect of intra-articular~     (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections)~     in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less~     than 5 joints but including at least one knee. 10 patients will receive IA infliximab~     injections to the affected knee, 10 will receive IA steroid injections to the affected knee~     and 10 will receive a course of intravenous infliximab. Patients will not be aware of their~     group as this is a placebo-controlled study.~   "
140434|NCT01216618|"~     The study is a prospective, multi-center, open label, randomized; two-arms cross over study.~      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin~     delivery into the blood when the insulin is infused using an insulin-infusion pump by~     controlled heating of the area surrounding the point of infusion.~   "
140435|NCT01216605|"~     The present study was designed to investigate the effects of a single dose of synthetic~     oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are~     presented very briefly for a few milliseconds in a backward-masking paradigm in order to~     vary the level of awareness. In a randomized placebo-controlled between-subject design,~     recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition.~     We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed~     with limited awareness.~   "
140436|NCT01216592|"~     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high~     prevalence worldwide and with relevant impact on patient-related quality of life, morbidity~     and mortality. There is evidence that airway inflammation correlates with the severity of~     the disease and that airway inflammation is further enhanced during exacerbation. However,~     it is unknown whether daily fluctuation of symptoms or changes in lung function is~     paralleled by changes in airway inflammation.~   "
140437|NCT01216579|"~     The investigators hypothesise that titration of asthma medication against mannitol challenge~     results will reduce the number of mild asthma exacerbations, in one year, when compared with~     titration against BTS guidelines. To test this hypothesis the investigators propose a~     primary care, parallel treatment, patient blinded study in which matched groups of asthmatic~     patients will be treated in accordance either with BTS guidelines or with our treatment~     algorithm dependent on mannitol challenge result.~      Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the~     measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of~     airway inflammation, in the long term treatment of asthma in comparison to BTS guidelines.~   "
140438|NCT01216566|"~     The purpose of this study is to investigate the efficacy and safety of the Occiflex device~     in the treatment of neck pain.~   "
140439|NCT01216553|"~     The aim of the study was to investigate the utility and safety of home management of home~     oxygen therapy in acute bronchiolitis. A matched case-control study, of one hundred and~     thirty five infants aged less than 12 months diagnosed bronchiolitis with hypoxia attending~     a pediatric community clinic will be randomly assigned to receive oxygen with or without~     standard nebulized therapy. Nebulized treatment with either 0.1% epinephrine diluted in~     bromhexine, or 3% hypertonic saline. Intermittent oxygen treatment will be administered 6~     times daily for 7 days. Primary outcome measures will be emergency department~     visits/hospitalization secondary outcome measures will be changes in Bronchiolitis Caregiver~     Diary Score.~   "
140440|NCT01216540|"~     The primary goal of this study is to determine if there is an association between greater~     exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to~     estimate the costs to the hospital associated with these nephrotoxic events.~   "
140441|NCT01216527|"~     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery~     versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III~     squamous cell esophageal carcinoma.~   "
140452|NCT01216384|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and~     healthy Japanese male volunteers following single oral administration and multiple~     administrations.~   "
140442|NCT01216514|"~     Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on~     clinical factors (extension of the disease, achievement of the perianal ring, requirement of~     surgery, treatment by immunomodulators…). All IBD specific immunological or serological~     markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs~     Crohn Disease) but were never able to be considered as predictive elements of adults IBD~     evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate~     hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their~     combination present an average sensibility about 85 % and a 85 % specificity. However, 8~     other antibody types were recently isolated and estimated individually during IBD in~     particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA,~     AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These~     complementary assays improve significantly the reliability of the diagnosis. However, if the~     use of these new markers has an indisputable diagnostic role, their predictive role in the~     evolution of IBD was estimated at the adult's only rarely during Crohn diseases.~     Consequently, the investigators suggest realizing an exhaustive analysis of all these new~     immunological markers to define, if their association can have an interest in the~     differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary)~     clinical forms.~   "
140443|NCT01216501|"~     In children, radiofrequency catheter ablation (RFCA) or cryoablation are highly effective~     treatments for supraventricular tachycardia treatment. General anesthesia is often required~     to ensure comfort during the prolonged procedure and to assure immobility in order to~     facilitate accurate mapping and subsequent ablation of the accessory pathway and/or~     arrhythmogenic focus. Successful anesthetic management of this patient population requires~     adequate suppression of sympathetic responses during the procedure while~     electrophysiological parameters remain unaltered for mapping purposes and subsequent~     ablation. Although Sevoflurane (SEVO) and Isoflurane (ISO) are two commonly used and~     evaluated volatile anesthetic agents for ablation procedures, comparison of those agents has~     not been performed previously not in adults, not in children.~      Hypothesis Time required for basic EP intervals, successful induction of SVT and successful~     RFCA or cryoablation in children will not be different between patients undergoing~     Sevoflurane or Isoflurane-based anesthesia.~   "
140444|NCT01216488|"~     Hospitalized patients for superior member surgery have different types of anesthesia.Forearm~     and/or arm surgery could be done under general anesthesia, but in the most of the cases,~     this surgery was done under locoregional anesthesia.Several injections of local anesthesia~     at the nerves axilla are used with the used of ultrasonography.~      The purpose of this study is to show that the anesthesia efficiency is the same with 40 or~     25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.~   "
140445|NCT01216475|"~     Background: Small Incision Lenticule Extraction or SMILE is a novel form of 'flapless'~     corneal refractive surgery that was adapted from Refractive Lenticule Extraction (ReLEx).~     SMILE uses only one femtosecond laser to complete the refractive surgery, potentially~     reducing surgical time, side effects and cost. If successful, SMILE could potentially~     replace the current, widely practiced Laser In-situ Keratomileusis or LASIK. The aim of this~     study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes~     at 3-months post-operatively.~      Methods/ Design: Single tertiary center, parallel group, single-blinded, paired-eye design,~     non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will~     be enrolled for study after informed consent. Each participant will be randomized to receive~     SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority~     trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (>~     -3.00D) at a tertiary eye center in terms of refractive predictability at 3 months~     post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial~     would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00D) at a~     tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order~     aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability,~     which is one of several standard refractive outcomes, defined as the proportion of eyes~     achieving a postoperative spherical equivalent (SE) within ±0.50 diopter (D) of the intended~     target. Randomization will be performed using random allocation sequence generated by a~     computer with no blocks or restrictions, and implemented by concealing the number-coded~     surgery within sealed envelopes until just before the procedure. In this single-blinded~     trial, subjects and their caregivers will be blinded to the assigned treatment in each eye.~      Discussion: This novel trial will provide information on whether SMILE has comparable, if~     not superior, refractive outcomes compared to the established LASIK for myopia, thus~     providing evidence for translation into clinical practice.~   "
140446|NCT01216462|"~     The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology~     and current management of Acute Coronary Syndromes in the Lazio Region of Italy.~   "
140447|NCT01216449|"~     Antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) are most~     commonly prescribed to treat depression and anxiety. How antidepressants work on the brain~     to alter mood and behaviour is not well understood. This study will use a brain scanning~     technique (functional magnetic resonance imaging) to examine how aging impacts brain~     activation during emotional tasks after the administration of intravenous (IV) citalopram~     (this is the only SSRI available in this form, and is well tolerated and safe in young and~     old adults). The investigators will further determine what role genetic differences play in~     this relationship. The investigators expect to see an increase in brain signal as the~     concentration of IV citalopram increases. However, the investigators propose that the brain~     signal in older adults will not be as strong as in younger adults. Furthermore, the~     investigators expect that participants genetically predisposed to have fewer serotonin~     transporters (the site of action of SSRIs) will show greater decreases in brain activation~     with citalopram.~   "
140448|NCT01216436|"~     Our proposed study is designed to test the safety of a new vaccine against melanoma. The~     induction of immune activity against cancers such as melanoma is a promising approach to~     cancer treatment, but to date, only a few clinically significant immune responses have been~     seen following vaccine therapy. This is an important problem, since there are very limited~     treatment options for patients with metastatic melanoma (melanoma that has spread to lymph~     nodes and organs).~      Studies suggest that monoclonal antibodies (mAbs) that block inhibitory receptors on immune~     cells can enhance the immune responses against cancer, but the intravenous injection of such~     mAbs has caused severe side effects in animals and humans. In our laboratory, we have~     developed a method to deliver mAbs and other proteins that block such inhibitory receptors~     locally at the site where immune responses against melanoma proteins are stimulated by~     vaccination, enhancing anti-melanoma immunity while avoiding the side-effects associated~     with intravenous injection of these immune modulators. This is achieved by loading dendritic~     cells, a type of immune cell, with RNA that encodes the immune modulator. The RNA-loaded~     dendritic cells then make the immune modulatory proteins and release them locally. By mixing~     these dendritic cells with additional dendritic cells loaded with melanoma proteins, the~     immune modulators are released at the site where anti-melanoma immune cells are stimulated.~      In this phase I trial, subjects with metastatic melanoma will undergo the process of~     leukapheresis, in which white blood cells are removed from the body. Monocytes, a type of~     immune cell, will then be purified from the white blood cells and cultured under conditions~     that will change them into dendritic cells. Half of these dendritic cells are then loaded~     with melanoma antigen RNA, which will lead to the production of melanoma antigen proteins~     within the dendritic cells. The remaining half of the dendritic cells will be either~     untreated or loaded with RNA encoding immune modulators so that these dendritic cells will~     release immune modulators at the site of vaccination. These dendritic cells will be mixed~     with the melanoma antigen-loaded dendritic cells and injected as a vaccine into lymph nodes.~     Each subject will receive six weekly injections of their own dendritic cells. Safety and~     toxicity will be closely monitored. In addition, immune responses against melanoma, as well~     as clinical responses, will be assessed.~   "
140454|NCT01216358|"~     The objectives of this prospective, descriptive study are to:~        1. generate estimates of the incidence, prevalence, persistence, clinical impact and~          attributable risk of migraine due to hormonal contraception (HC) use; and~        2. identify predictive factors for clinically significant changes in headache attributable~          to HC use.~      The investigators hypothesize that:~        1. Most women with pre-existing migraine will have no significant change from baseline~          headache frequency or clinical impact attributable to HC at 3 months following~          initiation; a minority will report clinically significant worsening or improvement~        2. The incidence of headache and migraine in HC users will not be significantly different~          from their incidence in NHC users~        3. There will be identifiable risk factors for development or worsening of~          headache/migraine in the minority of HC users where that occurs.~   "
140455|NCT01216345|"~     The aim of this prospective single-centre phase II study is to investigate the therapeutic~     efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in~     the palliative first line treatment of biliary tract cancer (BTC) patients.~   "
140456|NCT01216332|"~     This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent~     inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with~     Acute Lymphoblastic Leukemia.~   "
140457|NCT01216319|"~     Patients with a desire for nipple reconstruction following breast cancer and breast~     reconstruction will receive a surgical procedure to reconstruct one or both nipples~     utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.~   "
140458|NCT01216306|"~     Obesity has been linked to the development of multiple cancers, and to poorer prognoses and~     higher mortality rates for certain pediatric and adult cancers. Preventing obesity is~     therefore a major strategy to prevent new cases of cancer and to decrease cancer related~     morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood~     obesity strongly tracks into adulthood this epidemic among children greatly increases the~     risk of obesity and presumably cancer in adulthood. As a result, preventing childhood~     obesity has been selected as a major public health goal to reduce the risk and sequelae of~     obesity and cancer in the US.~      Moreover, television (TV) viewing has been identified as a major risk factor for childhood~     obesity and US children spent more time watching TV than any other activity except sleep. TV~     viewing contributes to excess weight gain by decreasing physical activity and increasing~     caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for~     parents to limit their children's total entertainment media time to no more than 1 to 2~     hours of quality programming per day for children greater than 2 years of age. Low-income~     and minority children were at greater risk for exceeding this recommendation.~      Few published interventions have been successful in decreasing TV viewing in children and~     only one was successful among preschool children. This intervention, Fit 5 Kids (i.e. fit~     by age 5 years), was a preschool curriculum designed to decrease TV viewing via~     age-appropriate lessons taught to the children by research staff. The curriculum also~     included a take-home component consisting of a newsletter with ideas for parent (for this~     grant, defined as the adult most responsible for the child's care, usually the mother) and~     child activities that complemented the school lesson plans. Although most behavioral~     interventions for preschoolers target parents rather than children, this curriculum was one~     of the few successful interventions targeted directly at children. However, Fit 5 Kids was~     not designed for or evaluated among Hispanic preschool children, the subpopulation of~     preschool children most severely affected by obesity. Moreover, no published intervention~     has successfully reduced both TV viewing and excess weight gain in any preschool population.~     In order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5~     Kids TV reduction curriculum among Hispanic preschool children enrolled in the Head Start~     Program.~      Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion~     program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV~     watching and encourage alternative activities such as family meals and active playtime. The~     primary goal of this research plan will be to conduct a pilot group randomized controlled~     trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess~     weight gain in low income, Hispanic preschool children~      To achieve the project goals, the investigators Specific Aim includes:~      1. To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start~     centers each year for 3 years and conduct a group randomized controlled study of the adapted~     Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight~     gain in Hispanic preschool children.~      The Primary Hypothesis to be tested includes:~      H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight~     gain among Hispanic preschool children.~   "
140459|NCT01216293|"~     The purpose of this study is to evaluate the effect of dexlansoprazole modified release~     (MR), once daily (QD), on bone homeostasis.~   "
140460|NCT01216280|"~     This study is to evaluate the efficacy and tolerability of multiple oral doses of~     Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a~     randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will~     complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical~     sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo,~     Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending~     Sponsor approval, if it appears that less than 60 patients will complete the study.~   "
140461|NCT01216267|"~     The goal of this study is to compare several methods for measurement of Chromogranin A in~     their ability to serve as a marker for disease activity in patients with neuroendocrine~     tumors.~      Further, in a subgroup, we will determine if taking a proton pump inhibitor affects~     Chromogranin A levels.~   "
140462|NCT01216254|"~     The aim of this study is to assess the outcomes of breast conserving therapy operation~     depending on the type of surgical tool used: classic electrocoagulation with higher~     operative temperatures and high frequency electrocoagulation with lower operative~     temperatures. The investigators would assess the pain levels, length and amount of the~     lymphatic secretion as well as quality of life following breast conserving surgery.~   "
140463|NCT01216241|"~     The purpose of this study is to evaluate the benefits and side effects of daptomycin~     compared to placebo for the treatment of neutropenic fever.~   "
140464|NCT01216228|"~     Health outcome studies should examine food patterns, because foods are consumed together and~     nutrients are metabolized jointly. To examine associations between food patterns and markers~     of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö,~     Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.~   "
140465|NCT01216215|"~     Research Problem Asthma is one of the most common chronic diseases in the world that affects~     approximately 300 million individuals worldwide. It is characterized by airway inflammation~     and bronchoconstriction leading to airflow obstruction, however, the triggering factors~     behind asthma development remains to be elucidated. Genetic risk factors have been suggested~     to play a central role in asthma development. Twin studies supported a strong genetic~     component to asthma, especially childhood asthma, with heritability estimates suggesting~     that 48-70% of asthma risk is attributed to genetic risk factors. Suggestive susceptibility~     genes have been identified in European and American populations but not yet in the Middle~     East including Saudi Arabia. Identified genes whether they are polymorphic variants of genes~     encoding known pathophysiological molecules or novel genes identified by linkage or~     genome-wide association studies (GWAS) are inconsistent in different populations thereby~     adding to the need to undertake genetic studies on different ethnic populations and in~     different countries. Here, the investigators hypothesize that polymorphic variation of novel~     susceptibility genes form a major risk factor for asthma development, response to treatment~     and progression in the Saudi population with strong diagnostic, prognostic and therapeutic~     implications.~      Research Significance Since the manifestation of complex inflammatory disorders with strong~     heritability is complex involving genetic and environmental interaction, each ethnically~     distinct population must be examined to know whether gene-disease association exists in that~     population. The objectives of this proposal are to discover novel asthma susceptibility~     genes in the Saudi population. A better understanding of the genetic mechanisms of asthma~     will enhance our knowledge of its pathophysiology. Asthmatic patients with distinct~     genotypes respond differently to asthma medications. Therefore, improvements in diagnostics~     and pharmacogenetics may be the first clinical developments of these extensive studies. This~     embraces the concept of asthma subphenotypes and stratified medicine where interventions are~     targeted at those individuals who will best benefit from them with minimal side effects.~     Physicians looking after asthmatic patients will be able to provide better medical service~     tailored to those patients, as well as to identify Saudi people at high risk for the~     development of asthma, especially the more severe forms of the disease.~      Research Objectives The main objective of our proposal is to identify known and novel asthma~     susceptibility genes in the Saudi population and to investigate their interaction with~     clinical, environmental, and inflammatory factors contributing to asthma pathophysiology.~      Research Methodology In this proposal, the investigators will investigate the genetic~     factors contributing to asthma susceptibility by determining in Saudi population, the~     presence of single nucleotide polymorphisms (SNPs) that have been previously reported from~     linkage and GWAS in other populations. Whole genome DNA will also be scanned for novel SNPs~     of selected asthma genes using microarrays. This will enable us to identify new SNPs that~     contribute to the risk of asthma specifically in the Saudi population. In addition, the~     investigators will cross-reference all genetic and immunological parameters with the~     corresponding clinical data in order to elucidate the impact of certain genes, or their~     products (e.g. cytokines), on the clinical manifestation of asthma.~   "
140466|NCT01216202|"~     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal~     cancer. For men there are theoretical reasons to believe that the treatment may effect~     hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a~     longitudinal observational study was initiated where patients can choose to take part in~     one, two or three parts of the study. The three different parts are blood tests,~     questionnaires and semen samples.~   "
140467|NCT01216189|"~     Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal~     cancer.For women there are theoretical reasons to believe that the treatment may affect~     hormone levels, sexual function and wellbeing. To address these questions a longitudinal~     observational study was initiated where patients, before preoperative radiotherapy and one~     year after surgery, take blood tests and answer two questionnaires.~   "
140468|NCT01216176|"~     The investigators propose to conduct a Phase I/randomized Phase II study design in order to~     test the tolerability and efficacy of AZD0530 when used together with anastrozole in therapy~     for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of~     the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed~     initial safety,tolerability and good bioavailability of both drugs and determined the doses~     for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study~     (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2~     negative breast cancer that is at least 2 cm or more in diameter by clinical exam or~     radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo,~     or anastrozole in combination with AZD0530. The Phase II cohort will permit extended assays~     of tolerability, initial estimates of efficacy, and the investigation of molecular~     predictors of drug efficacy.~   "
140469|NCT01216163|"~     This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen~     formulation to placebo and acetaminophen in the treatment of post-surgical dental pain~     following wisdom tooth (third molar) removal.~   "
140492|NCT01215864|"~     This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific~     inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The~     objectives of this study are to evaluate the safety of the drug and to determine the maximum~     tolerated dose and appropriate dose for phase II studies. Secondary objectives are to~     measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation~     cohort only, to evaluate the potential correlation between the levels of tumor choline and~     tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance~     spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the~     maximum tolerated dose confirmation cohort.~   "
140470|NCT01216150|"~     Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary~     syndromes. Although the maintenance of aspirin until surgery does not affect postoperative~     bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically~     increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and~     results: This prospective observational study will include 136 consecutive patients~     scheduled for first-time CABG. Postoperative bleeding and blood transfusion requirements~     will be compared (non inferiority)between patients pretreated during a period of 5 days~     prior surgery by either aspirin alone or combined with clopidogrel. Tranexamic acid will be~     systematically used in all these patients considered as high risk for bleeding.~      In concusion, this study has to to test the hypothesis that with tranexamic acid also,~     bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin~     alone group after CABG surgery, according to the previous study using aprotinin.~   "
140471|NCT01216137|"~     The purpose of this study was to test the feasibility and effectiveness of a novel exercise~     intervention for individuals who live with multiple sclerosis (MS).~   "
140472|NCT01216124|"~     The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and~     not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is~     based on three standard immunohistochemical biomarkers.~      In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer~     patients in adjuvant or neoadjuvant settings. Oxaliplatin,~     trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents.~     Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription~     and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the~     Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and~     ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to~     the results of some retrospective studies. There was no report about Oxaliplatin in the~     chemotherapy setting for breast cancer patients.~      The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible~     and active in patients with TNLABC because in vitro findings suggest synergism between the~     agents. This study was designed to investigate the efficacy and toxicity of~     oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple negative local~     advanced breast cancer patients~   "
140473|NCT01216111|"~     Previous studies in Western country show that triple-negative breast cancer has aggressive~     clinical and pathological features compared with non-triple negative breast cancer,~     including onset at a young age, advanced clinical stage, high histologic and nuclear grade~     and more distant recurrence.~      According to the characteristics of triple negative breast tumor, the TNBC patients can~     benefit neither from hormonal therapies nor from target therapies against Her2 receptors.~     The only systemic therapy currently available is chemotherapy, and prognosis remains poor.~     It becomes more and more important to investigate the sensitive chemotherapy regimen for~     triple negative patients.~      Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and~     ect. Triple negative breast cancer patients were more sensitive to platinum-based~     chemotherapy regimens according to the results of some retrospective studies.~      The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to~     triple negative breast cancer compared with CEF followed by docetaxel.~   "
140474|NCT01216098|"~     The purpose of this study is to evaluate the impact of doula support on childbirth outcomes~     of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC).~     Doulas are paraprofessionals who provide women with continuous physical and emotional~     support throughout the course of labour. They also conduct home visits in the prenatal and~     postpartum periods in order to provide women with information on childbirth-related topics~     and breastfeeding support. They do not perform clinical tasks. Their value lies in the~     psycho-social care that they provide. It is hypothesized that women who receive doula~     support alongside standard care will have a lower rate of epidural analgesia use and greater~     cervical dilation at time of epidural administration, as compared to those who receive~     standard care alone.~   "
140475|NCT01216085|"~     This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of~     high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at~     60 months after Glivec administration will be described.~   "
140476|NCT01216072|"~     The purpose of this study is to evaluate the change in patient-reported outcomes, physician~     assessment of a change as well as safety and tolerability in patients with Relapsing Forms~     of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one~     of two treatment arms: fingolimod vs. standard of care DMT.~   "
140477|NCT01216059|"~     Atopic dermatitis is a common problem faced by patients of all ages and backgrounds.~     Treatment regimens and specific therapies may be time consuming and multiple studies have~     documented a parallel decrease in compliance as time after an office visit increases. The~     adolescent population is an extremely challenging sub-group of patients in terms of~     complying with a treatment regimen. Not only are they striving for independence and thus~     lacking supervision of a regimen by a parent, but their complex thinking skills are~     immature, leading to forgetful behavior. By introducing a reminder system for these~     vulnerable patients that is easily incorporated into their daily lives, the investigators~     propose that patients will have better compliance at applying their medication and thus~     improving their atopic dermatitis. Text-messaging via cell phones has become very popular~     among teenagers and adults and provides a non-obtrusive method of sending a treatment~     reminder.~   "
140478|NCT01216046|"~     The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770~     alone and in combination in healthy subjects.~   "
140479|NCT01216033|"~     The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding~     molecule 111-In-ABY025 and if that shows whether the metastases express HER2.~   "
140493|NCT01215851|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with~     pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of~     change of log CFU in sputum over the time period Day 0-14 in participants with smear~     positive pulmonary tuberculosis (TB). A control group will receive standard treatment.~   "
140494|NCT01215838|"~     The purpose of this study is to determine if a new magnetic resonance (MR) protocol is~     better at diagnosing liver lesions.~   "
140480|NCT01216020|"~     BACKGROUND:~      Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment~     for LA-NHSCC. This combined modality treatment is linked with considerable acute local and~     systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an~     unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC~     pathogenesis.~      Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and~     signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only~     in the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.~      RATIONALE:~      A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant~     treatment with radiotherapy associated to cetuximab does not exist.~      STUDY DESIGN:~      Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin~     (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy~     with the monoclonal antibody Cetuximab (400 mg/m2 [loading dose] and subsequently 250 mg~     /m2/week)~   "
140481|NCT01216007|"~     The objective of this pilot study is to compare plasma [bupivacaine] between two groups of~     paediatric patients under general anaesthesia who will all receive regional caudal~     anaesthesia with bupivacaine: group 1 will receive TIVA and group 2 will receive a volatile~     anaesthetic.~   "
140482|NCT01215994|"~     The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin~     C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51~     labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.~   "
140483|NCT01215981|"~     Study Design:~      This is a randomized, single center study to evaluate immune responses to the seasonal~     influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who~     receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy~     adult volunteers will be recruited as controls to confirm immune response to a single~     influenza vaccine.~   "
140484|NCT01215968|"~     The primary purpose of this Study is to help answer the following research question(s).~        -  How does LY2189265 affect gastric emptying (the speed at which food and drink leaves~          the stomach) in patients with Type 2 diabetes?~        -  How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2~          diabetes)?~        -  Is LY2189265 safe and are any side effects associated with it?~      The study will be participant-blind in Week 1, and participant- and investigator-blind from~     Week 2 through Week 5.~      Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or~     Placebo on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes~     Mellitus (T2DM) will continue taking metformin as part of the study.~   "
140485|NCT01215955|"~     Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature.~     The purpose of this study is to evaluate the efficacy and safety of two approaches to~     escalate prandial insulin therapy in participants with type 2 diabetes mellitus not~     achieving adequate glycemic control on basal insulin.~   "
140486|NCT01215942|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective~     during long-term treatment in patients with Rheumatoid Arthritis.~      This study is comprised of 2 periods:~      Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study~     H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168~     weeks for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).~      Period 2 - 48 week post treatment follow up~   "
140487|NCT01215929|"~     Methamphetamine use is very common in the US and is associated with serious medical and~     psychiatric problems. There has also been a significant increase in the number of patients~     entering treatment for methamphetamine dependence, however, no pharmacologic treatment has~     been identified as effective in treating methamphetamine addiction. Given that withdrawal~     from methamphetamine is thought to contribute to relapse to methamphetamine use during early~     treatment, it is important to examine potential pharmacologic agents for alleviating~     withdrawal. Thus, this study is designed to study methamphetamine withdrawal in humans. To~     this end, 30 methamphetamine dependent participants (ages 18-65 years) will be entered into~     a 4-week residential study. Urine samples will be obtained at baseline to ensure recent~     methamphetamine use. Intake assessments will include cognitive testing, standardized~     assessment of depression and anxiety, profile of mood states, methamphetamine selective~     severity assessment, methamphetamine withdrawal assessment, sleep quality and quantity, a~     pre-attentional measure and attentional measure. Upon admission to the residential facility,~     all study participants will be started on (20-30mg) long acting amphetamine/d-amphetamine~     and stabilized over the first 5 days. After stabilization participants will be randomized~     based on sex, amphetamine withdrawal questionnaire score, and methamphetamine selective~     severity assessment score to either continued treatment with amphetamine/d-amphetamine or~     placebo for 2 weeks. All subjects will then be placed on placebo for the last 7 days. The~     investigators hypothesis is that stopping amphetamine administration in methamphetamine~     dependent individuals will negatively impact mood, sleep and cognitive function in a~     time-limited fashion that may differ depending upon the measure and that attentional, but~     not pre-attentional, measures will be adversely affected in those receiving placebo compared~     to those maintained on amphetamine.~   "
140488|NCT01215916|"~     The primary objective of this study is to determine the MTD regimen for the combination~     therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid~     tumor that is not amenable to curative therapy.~   "
140489|NCT01215903|"~     The present study was conducted to test whether a fish gelatin supplement combined with an~     omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects~     on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure,~     lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant~     men and women. The investigators hypothesis is that fish gelatin improves insulin~     sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or~     overweight insulin-resistant men and women.~   "
140490|NCT01215890|"~     The occurrence of bone loss in Crohn's disease patients is an important clinical problem for~     both patients with and without active disease. While therapy does exist for treatment and~     prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The~     current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with~     adequate calcium and vitamin D supplementation.~      The primary objective of the study is to assess the efficacy of risedronate, compared to~     placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in~     patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.~   "
140491|NCT01215877|"~     The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination~     with other chemotherapy agents are active in patients with advanced and metastatic bladder~     cancer, and agents of this class are a promising treatment option for some patients.~      Tesetaxel is an orally administered taxane that is in development as treatment for subjects~     with advanced cancers. This study is being conducted to determine the efficacy and safety of~     tesetaxel administered to patients previously treated with chemotherapy for progressive~     metastatic transitional cell carcinoma of the urothelium.~   "
140496|NCT01215812|"~     The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations~     and treatment characteristics of cases of sexual assault sought emergency care at Far~     Eastern Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital,~     Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin~     Branch、Hospital and National Taiwan University Hospital.~   "
140497|NCT01215799|"~     This is a Phase II open-label study evaluating the preliminary efficacy and safety of~     bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory~     Prostate Cancer.~   "
140498|NCT01215786|"~     This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3~     doses of AGN-207281 based on an ongoing review of data during the study period compared with~     timolol ophthalmic solution or placebo in patients with ocular hypertension or primary~     open-angle glaucoma.~   "
140499|NCT01215773|"~     The main objectives of the multiple dose study are to investigate the safety, tolerability~     pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple~     oral administration of BI 671800~   "
140500|NCT01215760|"~     Objectives: To develop a protocol for early treatment using sensory reeducation through the~     mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its~     comparison with the evolution of the return of skin sensitivity after a not early~     rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.~   "
140501|NCT01215747|"~     The primary purpose of this study is to assess the efficacy and safety of treatment with~     Kiacta in adult patients with AA Amyloidosis.~   "
140502|NCT01215734|"~     Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant~     (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not~     be significantly different from adult stem cell transplant recipients receiving standard~     dose (SD) TIV.~        -  Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza~          vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic~          stem cell transplant recipients.~      Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent~     influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody~     titers to influenza antigens compared to those who receive standard dose trivalent influenza~     vaccine.~        -  Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell~          transplant recipients influenza virus antigens included in trivalent influenza vaccine~          after high dose or standard dose trivalent influenza vaccine.~   "
140503|NCT01215721|"~     Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading~     cause of death from cancer in men. Radical prostatectomy is one of the treatment options~     available for organ-confined disease. Over 100,000 radical prostatectomies cases (total~     removal of the cancerous prostate by surgery) are performed in the United States yearly.~     Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life~     (QOL) scores due in part due to a postoperative incontinence which may require the use of~     multiple urinary pads per day. Many of these men also report debilitating irritative voiding~     symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction~     scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients~     symptoms may persist for longer periods.~      Our recent published findings suggest that instability in the bladder muscle is likely an~     underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle'~     instability results in excess contractions of the urinary bladder ('urgency to urinate'),~     and can result in the feeling of needing to urinate more frequently. Consistent with this~     hypothesis of detrusor muscle instability, men with postoperative dribbling had more~     complaints with urgency, frequency and bother scores when queried with validated~     questionnaires. We suspect that a transient bladder muscle contraction may overcome the~     urinary sphincter valve resistance and result in the patient's dribbling of urine.~      By treating the bladder muscle instability, we expect improved postoperative continence and~     improved quality of life in patients after undergoing surgery for total removal of a~     cancerous prostate. This pilot study will assess the statistical requirements for the number~     of subjects needed for a fully 'powered' randomized prospective study to fully evaluate~     whether medications such as solifenacin significantly improve patients' quality of urinary~     life and improve postoperative urinary incontinence after surgery.~      *This study has been modified from the original protocol with the clinicaltrials.gov ID:~     NCT00581061.~   "
140504|NCT01215708|"~     The investigators objective is to study if some drugs can improve the success rate of~     extracorporeal shockwave lithotripsy for renal stones.~   "
140505|NCT01215695|"~     We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with~     general anesthesia including endotracheal intubation. Patients qualify for the trial if they~     are considered a difficult airway case as determined by measurement of common predictive~     indices for difficult intubation (see inclusion criteria). All patients will be intubated~     with a GVL. Patients will be randomly assigned to either having their ETT placed with use of~     a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a~     flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The~     randomization will be stratified as to whether patients are categorized as predicted~     difficult airway or have an immobilized cervical spine (C-collar in place).~   "
140506|NCT01215682|"~     Background: The medical and economic burden of upper respiratory tract infections (URTIs) is~     extremely high, while prevention and treatment options are limited. Therefore, there is a~     constant need for new methods in order to significantly decrease such morbidity. Extensive~     evidence shows that vitamin D is associated with respiratory health, including in the~     prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and~     can serve as a model for research in this field.~      The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D~     levels will reduce the frequency, length, and severity of URTIs and their accompanying~     functional impairment, while improving cellular immune function and physical function.~      Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum~     levels of vitamin D, this study group will be randomized to receive either vitamin D~     supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months.~     Participants will fill a daily questionnaire regarding frequency, length and severity of~     URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin~     D status (25(OH)D) and immune function among study participants at the beginning of the~     study and after supplementation. Physical function on land and in water will also be~     assessed.~      Expected results: Increase in serum 25(OH)D levels following supplementation will~     significantly decrease the frequency, length and severity of URTI's and their functional~     impairment, while enhancing the cellular immune system function and physical capacity.~   "
140549|NCT01215123|"~     This observational study will assess the median time of treatment duration and the safety of~     Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer.~     Data will be collected for approximately 24 months.~   "
140507|NCT01215669|"~     This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season~     formulation of intradermal (ID) influenza vaccine as part of a post registration commitment.~      Objectives:~        -  For all groups, to evaluate compliance, in terms of immunogenicity, of the~          corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine~          Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee~          for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96~        -  For all groups, to describe the safety~   "
140508|NCT01215656|"~     The objective of the study is to evaluate the effects of a follow on formula containing the~     human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old~     infants.~   "
140509|NCT01215643|"~     The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with~     either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard~     of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2~     and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to~     participants not achieving rapid viral response (RVR) in the different arms.~   "
140510|NCT01215630|"~     The primary aim is to study the relationship between vascular function, cardiovascular~     fitness and age in healthy subjects. Individuals with the highest cardiovascular fitness~     will have the greatest arterial inflow independent of age.~   "
140511|NCT01215617|"~     The purpose of this study is to investigate if 3 months of interval training improves~     obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive~     sleep apnea. The working hypothesis is that 3 months of 3 weekly aerobic interval training~     sessions improve obstructive sleep apnea and sleep quality in obese patients.~   "
140512|NCT01215604|"~     The investigators propose that the translation initiation factors eIF4E and eIF4GI may be~     involved in resolution of acute inflammation (regardless of age). Furthermore, the~     investigators suggest that differences in translation initiation factors state of activation~     may contribute to inflammation. Finally, the investigators hypothesize that differences in~     translation initiation factors state of activation may underlie the immune compromised state~     of the very elderly affording additional explanation for the heightened morbidity from~     infection in this group.~      In the current study the investigators aim to test these hypotheses by measuring the levels~     of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly~     (85yrs<) patients hospitalized at Meir hospital for acute infection and after their recovery~     (detailed in study design).~   "
140513|NCT01215591|"~     To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or~     less~   "
140514|NCT01215578|"~     The purpose of this study is to identify predictive molecular markers of response to~     continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated~     Advanced/Inoperable NEURO-Endocrine Tumors.~      Hypothesis:~        -  To distinguish molecular markers based on their expression at the initial biopsy, their~          detection by proteomic analysis and demonstrating that tumor or vascular cells are~          straightaway sensitive to sunitinib (markers sensitivity).~        -  The presence of these markers at the initial biopsy predict the sensitivity to~          sunitinib(Positive predictive value of markers)~   "
140515|NCT01215565|"~     The purpose of this study is to evaluate the antitumor activity of sunitinib in patients~     with advanced/inoperable fibrolamellar hepatocellular carcinoma.~      Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor~   "
140516|NCT01215552|"~     This Positron Emission Tomography (PET) imaging study is designed to explore the~     relationship between HT-0712 dose level and inhibition of brain phosphodiesterase-4~     activity, in order to optimize the dosage regimens utilized in subsequent trials.~   "
140517|NCT01215539|"~     The purpose of this study is to determine whether panitumumab in combination with~     capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras,~     metastatic colorectal cancer patients.~   "
140518|NCT01215526|"~     Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed~     for a maximum of 3 years to estimate the progression free survival. Data on testosteron~     levels, QoL and LUTS will be collected if this information is available. Safety information~     (adverse events) will be collected.~   "
140519|NCT01215513|"~     This is an open-label, multi-centre single arm trial to investigate long-term safety and~     tolerability of degarelix in Korean patients with prostate cancer.~   "
140520|NCT01215500|"~     Patients with metastatic cancer are generally treated with chemotherapy, which has improved~     median survival compared to best supportive care. Despite this, patients continue to have~     persistent disease at sites that were initially involved with cancer. Radiation therapy is~     an effective modality for treating localized cancer but generally has been only used for~     palliation of symptoms once a patient develops metastatic disease. Since patients often have~     persistent disease after chemotherapy, the goal of this trial is to use increasing doses of~     radiation therapy to all sites of involved disease in order to determine the safety and~     efficacy of hypofractionated radiation therapy.~      The purpose of this study is to establish a maximum tolerated dose, dose-limiting~     toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.~   "
140533|NCT01215331|"~     Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of~     insulin resistance due to the modifications of the pregnancy hormonal environment, and~     second, of the deficiency of the beta cells of the pancreas to respond by a sufficient~     insulin secretion. This physiopathology is closely connected to the one of type 2 diabetes.~     Insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral~     hypoglycemic agents which have been created to treat them: they are a natural choice because~     they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a~     sulfonylurea). It also seems natural to use them in combination, glyburide being added to~     metformin if needed.~      OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes~     mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed)~     allows a glycemic control comparable to the one obtained with insulin, but with a better~     acceptability from women and a better health status, diabetes treatment satisfaction and~     well-being and a reduced postnatal depression.~   "
140521|NCT01215487|"~     Imatinib (IM) is first-line treatment for patients with newly diagnosed CML in chronic~     phase. The drug is associated with high rates of cytogenetic responses with minimal toxicity~     in approximately 80% of patients. In 20% of patients however, the disease is either~     initially unresponsive to IM (Imatinib), resistance develops within a few months, or blast~     crisis occurs early and unexpectedly following an initial response. An increasing body of~     clinical evidence indicates that single agent molecularly targeted therapy (as in~     Gleevec/Imatinib) will not cure most patients with CML, as molecular remissions are rare.~     There is currently no clinically useful predictive tests to identify AT DIAGNOSIS those~     patients who are destined to be IM failures. The authors of this study have recently~     demonstrated that CML stem/progenitor cells are biologically insensitive to IM and are also~     genetically unstable and rapidly generate IM-resistant mutants in vitro and in vivo. The~     team recently discovered that the CD34 stem/progenitor cells of newly diagnosed CML patients~     who subsequently fail to respond to IM treatment show a reduced response to IM and a higher~     frequency of BCR-ABL mutations by comparison of 14 IM non-responders with 11 IM-responders.~     If this finding can be validated in a larger prospective cohort of patients, this predictive~     test could be used to more rationally design treatment plans with early addition of~     alternative therapies ie: Dasatinib or combination therapies for patients according to their~     individual risk profiles.~      Hypothesis:~      The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted~     by certain biological properties of their CD34 stem/progenitor cells which are variable~     among patients.~   "
140522|NCT01215474|"~     While current mutational analyses comprise exons 19 and 21 in which the majority of~     EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20~     mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to~     the above mentioned exons and correlate the results to the clinical outcome. This approach~     will enable us to potentially identify patients that might in the future benefit from~     targeted therapy (EGFR-inhibition).~   "
140523|NCT01215461|"~     The purpose of this study is to better understand the factors associated with mortality and~     identify potentially preventable causes of death in neonates who die after receiving health~     care. As a result, an improved neonatal mortality classification system may be defined.~   "
140524|NCT01215448|"~     This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations~     (diet, physical activity and breathing exercises) on the well being, fatigue and~     hematological parameters of chemotherapy-naive patients with no evidence for symptoms of~     active oncological disease.The researchers hypothesize that both wheatgrass juice and~     lifestyle recommendations can improve patient's well-being during chemotherapy.~   "
140525|NCT01215435|"~     This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control~     when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified~     treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic~     drugs) alone.~   "
140526|NCT01215422|"~     There are two new instruments on the market that anesthesiologists use when putting a~     breathing tube into the lungs of patients. The purpose of this study is to see how easily~     anesthesiologists can learn to use them in children.~   "
140527|NCT01215409|"~     In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study,~     data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile~     dysfunction. The general objectives are to evaluate the product safety (primarily by~     recording adverse events), efficacy and patient acceptance.~   "
140528|NCT01215396|"~     A number of studies have shown that ingestion of crystalline amino acids, in particular~     branched chain amino acids (BCAA) can affect endurance performance, markers of muscle~     damage, and possibly mental focus. It seems that the longer and lower intensity events are~     affected more by consumption of BCAA. This study will test the hypothesis that BCAA~     availability limits central fatigue (the feeling of tiredness). While various aspects of~     performance have been tested no study to date has tested multiple exercise, muscular, and~     mental performance aspects in a single study. Thus, the overall purpose of this study is to~     determine whether an amino acid supplement changes the mental and physical response to~     prolonged exercise versus a placebo (carbohydrate drink).~      This nutritional supplement could be useful on two levels. Improved mental focus and~     endurance performance and decreased central fatigue and muscle soreness could be valuable~     for enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness~     may increase the willingness of the general public to exercise which could translate into~     decreased health risks and increased health benefits.~   "
140529|NCT01215383|"~     Background:~      Among individuals with schizophrenia, there is an increased prevalence of obesity,~     dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease.~     People with severe mental illnesses, such as schizophrenia, depression or bipolar disorder,~     have worse physical health and reduced life expectancy compared to the general population.~     Number of epidemiological studies of patients with schizophrenia have documented a higher~     incidence of cardiovascular disease than in the general population, and patients with~     schizophrenia may be at an elevated risk for cardiovascular disease even in the absence of~     antipsychotic treatment.~      Affinity for the H1 receptor is most closely linked to increased weight gain, although~     affinity for D2, 5-HT1A, 5-HT2C and a2-receptors may also be involved. Drug affinity for the~     H1, M3 and 5-HT2C receptors is correlated with an increased risk of diabetes.~      High-density lipoprotein cholesterol (HDL-C) concentration in the blood is independently and~     inversely associated with an increased risk of cardiovascular disease(CVD). However many~     patients with 'normal' or even 'elevated' plasma HDL experience clinical events. HDL may not~     always be atheroprotective and in some conditions, it paradoxically enhances the process of~     atherosclerosis. In addition to its role in reverse cholesterol transport, HDL shows many~     other protective properties towards atherosclerosis. HDL inhibits the chemotaxis of~     monocytes , prevents endothelial dysfunction and apoptosis, prohibit slow-density~     lipoprotein (LDL ) oxidation, and stimulates the proliferation of endothelial cells and~     smooth muscle cells. These anti-inﬂammatory, antioxidative, antiaggregatory, anti-coagulant,~     and pro-ﬁbrinolytic activities are exerted by different components of HDL~      Aim of the study:~      To investigate the functional properties of HDL in psychiatric patients before and during~     antipsychotic therapy.~      Patients and methods:~      The blood will be drawn at baseline before the initiation of antipsychotic drugs and 2~     months under the antipsychotic treatment.~      Study procedures:~      Full lipid profile including triglycerides, LDL-C, Total cholesterol, HDL-cholesterol, apo~     AI, apoAII and apoB100.~      Serum Paraoxanase Activity~      LDL oxidation and resistance to oxidation (measured by conjugated diens formation during~     incubation in the presence of copper).~      HDL composition: total and unesterified cholesterol, triglycerides and phospholipids, TBARS~     content before and after exposure to AAPH as a major indicator of oxidative stress, PON~     activity using phenylacetate as a substrate, apoA1and PAF.~      Serum parameters e.g. Diacyl glycerol acyltransferase activity, free ApoA1 and LCAT~     activity.~      3 [H]-Cholesterol efflux will be measured by incubating J744 macrophages with serum.~     Radioactivity will measured by β counter in the cell lysate and the medium.~      Statistical methods:~      One-way AVOVA and Student's t-test for paired samples will be used for comparison of~     multiple groups and paired samples, respectively. p<0.05 will be considered significant.~   "
140530|NCT01215370|"~     The main objective is to investigate the postprandial effect of arginine-rich protein (i.e.~     pea-protein) on metabolic control, inflammation and endothelial function after a high-fat~     meal in subjects with characteristics of the metabolic syndrome.~   "
140531|NCT01215357|"~     This study is designed to test the hypothesis that ecopipam is able to reduce urges to~     gamble in patients diagnosed with Pathological Gambling.~   "
140532|NCT01215344|"~     The purpose of this study is to study the MRD status after VELCADE based induction therapy~     (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in~     patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on~     MRD status post‐transplant. Our hypothesis is that MRD‐status will continue to increase~     significantly at 3 months post‐transplant and will validate that HDC and ASCT needs to be~     performed even when patients have achieved major response after induction therapy with novel~     agents.~   "
140534|NCT01215318|"~     The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and~     can potentially impaire image interpretation.~      The aim of this study is to determine the etiology of this artefact and devine potential~     ways how to prevent it.~   "
140550|NCT01215110|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 at multiple doses as determined by the rate of change of logCFU in~     sputum over the time period Day 7-14 in participants with smear positive pulmonary~     tuberculosis (TB). A control group will receive standard treatment.~   "
140551|NCT01215097|"~     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of~     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of~     treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient~     glycaemic control.~   "
140535|NCT01215305|"~     The present study has been designed to provide current data on GERD prevalence in several~     regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to~     measure the treatment response in GERD patients, and to assess the correlations between the~     two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician~     and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to~     provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The~     XQS questionnaire will be applied for the identification of these patients and the~     assessment of the extraesophageal disease burden (frequency and intensity/severity).~     Finally, an association between the GerdQ and XQS scores will be attempted.~   "
140536|NCT01215292|"~     The purpose of this research study is to determine how much male hormone, testosterone, is~     necessary to maintain sperm production in the testis. This knowledge will be used to help in~     the development of a safe male hormonal contraception.~      Specific Aims:~        1. to determine if ketoconazole plus acyline will suppress intratesticular~          testosterone(ITT) to a greater degree than acyline alone.~        2. to determine if dutasteride plus acyline will suppress intratesticular~          dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.~        3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2)~          to a greater degree than acyline alone.~   "
140537|NCT01215279|"~     The purpose of the study is to investigate the tolerability and safety of AZD2423 in~     Patients with chronic obstructive pulmonary disease.~   "
140538|NCT01215266|"~     The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine~     and cisplatin in bladder cancer.~   "
140539|NCT01215253|"~     The purpose of the study is to see how effective a drug called ranolazine is in reducing the~     risk of ventricular arrhythmia and death in people with implantable~     cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is~     routinely prescribed in enrolled patients.~   "
140540|NCT01215240|"~     Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart~     surgeries before they turn three years of age. The first surgery typically happens in the~     first two weeks of life. After this operation, babies come back to the intensive care unit~     with their chests open. Babies who have heart surgery retain body water after surgery and~     this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of~     the extra water. As a result, babies have to stay in the intensive care unit and on a~     breathing machine for longer.~      Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly~     cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD~     involves putting small amounts of special fluid into the belly through the catheter. This~     special fluid attracts water and is drained hourly. By allowing the belly cavity to drain,~     this helps both the heart and the lungs. This allows the chest to be closed and the~     breathing tube to be removed. The investigators are looking to see how quickly the babies,~     with and without PD, get rid of the extra water in turn shortening their stay in the~     intensive care unit and in the hospital. PD is not permanent, and only used for the first~     few days after the operation.~   "
140541|NCT01215227|"~     The primary purpose of this extension study is to assess the long-term safety and~     tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and~     NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). The study will also~     characterize the long-term efficacy of preladenant in participants with PD.~      Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any~     adjunct medications during the study as prescribed by their physician. Several classes of~     adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase~     inhibitors, and dopamine agonists.~   "
140542|NCT01215214|"~     Identification and evaluation of endogenous markers for the assessment of CYP3A activity~     using metabolomics.~   "
140543|NCT01215201|"~     This study tries to determine whether the additional use of laser with cleaning (known as~     scaling and root planning) will result in the reduction of inflammation, reduction of~     bleeding upon examination and reduction of pocket depth in patients who are being maintained~     on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is~     bleeding, it is inflamed. It is usually cleaned with periodontal instruments (root-planed)~     to establish health. Some research also advocates using laser therapy to treat a bleeding~     pocket. Laser therapy is presently being performed in some dental offices and dental~     colleges. This research is trying to see if the additional laser therapy is beneficial.~   "
140544|NCT01215188|"~     This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation~     of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13™ based on immune~     responses to the 13 serotypes in common Prevnar 13™~   "
140545|NCT01215175|"~     This study is being conducted to evaluate the safety, tolerability, and immunogenicity of~     15-valent Pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and~     toddlers.~   "
140546|NCT01215162|"~     The study is being done to determine the tolerance to single fraction intra-operative~     electron irradiation (IOERT) and external beam photon irradiation (EBRT) following~     lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron~     beam boost irradiation that is usually given after EBRT. Data from two centers as well as~     preliminary data from a randomized trial in Europe suggest that IOERT boost is well~     tolerated and efficacious. In our study, patients will undergo standard lumpectomy and~     sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy~     will be delivered in a single fraction to the tumor bed by a mobile electron machine in the~     operating room. EBRT to the whole breast will be administered once the surgical wound has~     healed adequately. The primary objective is to determine the feasibility and acute patient~     tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of~     local control and distant control of disease, as well as evaluation of long-term side~     effects and cosmetic outcome of the treatment.~   "
140547|NCT01215149|"~     The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and~     Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and~     homologous prime-boost regimens at different time intervals.~   "
140548|NCT01215136|"~     The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel~     as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.~   "
140552|NCT01215084|"~     The primary objective of the study is to determine the Pharmacokinetic (PK) and safety~     profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The~     secondary objective of this study is to compare the PK and safety profiles of fampridine-PR~     10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.~   "
140553|NCT01215071|"~     Study is meant to evaluate the influence of different extension of pelvic lymphadenectomy on~     outcome of patients with bladder cancer.~   "
140554|NCT01215058|"~     The purpose of this study is to assess gastroprotective agent compliance in patients at risk~     suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.~   "
140555|NCT01215045|"~     Determine the clinical visual outcomes following bilateral implantation of the AcrySof~     ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects~     obtain spectacle freedom.~   "
140556|NCT01215032|"~     Metformin is a medication that is prescribed for people with diabetes to help the body~     respond better to its own insulin and decrease sugar production by the liver. This helps~     control the body's blood sugar level and is approved by the Food and Drug Administration~     (FDA) for the treatment of diabetes. Participant's in this research study will already be~     receiving androgen deprivation therapy (ADT) for prostate cancer. ADT is considered standard~     of care for prostate cancer. Changes in the participant's metabolism, including changes in~     insulin and blood sugar levels, are often seen as a result of this type of hormone therapy.~     Some studies have shown a relationship between insulin and prostate cancer. These studies~     have suggested that insulin may signal tumor cells to grow. Other studies suggest that~     people receiving metformin treatment for diabetes may enjoy better outcomes from their~     prostate cancer then other similar patients who are not treated with metformin.~   "
140557|NCT01215019|"~     Osmotic therapy is a mainstay in the treatment of intracranial hypertension after traumatic~     brain injury.This study proposes to compare two hypertonic saline agents in patients with~     traumatic brain injury.~   "
140558|NCT01214993|"~     The current study is designed to confirm the mechanism behind the increase in serum~     creatinine observed during GSK1349572 therapy; specifically, the study will determine~     whether GSK1349572 has any effect on glomerular filtration rate (GFR) or effective renal~     plasma flow. Absent such effects, one may conclude that the small increases in serum~     creatinine observed are due to the inhibition of the tubular secretion of creatinine via~     organic cation transporter 2 (OCT2) consistent with in vitro data. .~   "
140559|NCT01214980|"~     Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split~     thickness donor sites expected to be between 20 and 200 square cm will be consecutively~     screened for study eligibility. This study is a prospective, randomized, controlled trial~     evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites~     compared to standard care. Subjects meeting all eligibility criteria and providing~     appropriate written informed consent will be enrolled for study participation.~   "
140560|NCT01214967|"~     Premature infants are born at substantial risk for poor health and developmental outcomes,~     which commonly include hearing and vision problems, developmental delays, and poor school~     performance. Premature infants of low-income families face additional social risks known to~     worsen these outcomes. The Institute of Medicine recognized this important public health~     problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality~     of follow-up care for preterm infants discharged from the neonatal intensive care unit~     (NICU). The underpinning of this proposal is that maternal depression - common among~     families of premature infants - interferes with adherence to follow-up services, and (both~     through this mechanism and directly) adversely impacts child health and development.~     Conversely, alleviating depressive symptoms among these women represents a promising~     strategy to improve adherence to NICU follow-up services and to improve the outcomes of this~     vulnerable population.~      This project aims to mitigate the adverse effects of maternal depression in this specific~     high-risk population by testing a theory-based, parent-directed empowerment strategy, called~     Problem Solving Education (PSE). In the past, similar strategies have been proven effective~     for improving the mood and functioning of depressed adults, and for improving adherence to~     medical treatment. However, they have never been tested in the setting of a parent-child~     relationship or among families of premature infants.~      This project involves a clinical trial of PSE among 50 low-income mothers at risk for~     depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts~     Medical Center. The investigators aim to determine the impact of PSE on maternal depressive~     symptoms and functioning, and adherence to child health supervision and immunization~     schedules, vision screening, and early intervention evaluation for babies with suspected~     developmental delays.~      Approximately 100,000 children are born prematurely to low-income families each year.~     Parent-directed PSE aims to improve outcomes for these children through the prevention~     and/or attenuation of maternal depressive symptoms, as well as through family activation and~     promotion of adherence to follow-up care. If successful, PSE could also provide the~     cornerstone of a more generalizable empowerment strategy for families of children with~     chronic medical conditions.~   "
140561|NCT01214954|"~     The purpose of this study is to determine whether supervised progressive resistance training~     is effective in the early phase after Total Hip Replacement. The investigators hypothesise~     that 10 weeks of supervised, progressive resistance training immediately after discharge~     will lead to increased functional performance, muscle strength and muscle power compared to~     standard rehabilitation consisting of home-based exercise.~   "
140562|NCT01214941|"~     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and~     neuropathic pain. After oral administration, tramadol is rapidly and almost completely~     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed~     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation~     is catalysed by CYP2D6. The formation of inactive metabolites is catalysed by CYP3A4 and~     2B6. This study is aimed to investigate the possible interaction of oral tramadol with~     itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. Twelve healthy male or~     female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the~     ideal weight for height are taken into the study. Primary endpoints of the study are plasma~     concentrations of tramadol and its metabolites.~   "
140589|NCT01214590|"~     The purpose of this study is to assess the safety and the preliminary efficacy of treatment~     by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect~     with physiologic changes.~      Patients will undergo a 4-week period of home treatment by the VascuActive device, and will~     be monitored during this period and during a two-month follow-up period for the efficacy of~     the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.~   "
140590|NCT01214577|"~     This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel,~     0.015% when administered for up to three consecutive days to photo-damaged skin on the face.~     The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered~     for up to three consecutive days in patients with photo-damaged skin on the face.~   "
140608|NCT01214343|"~     The purpose of this study is to evaluate the efficacy of sorafenib in combination with low~     dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with~     advanced hepatocellular carcinoma.~   "
140563|NCT01214928|"~     Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once~     absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the~     kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues~     are capable of local vitamin D activation. This local tissue activity is important for~     maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are~     dialysis patients deficient in calcitriol due to kidney failure, but they are also~     deficiency in nutritional vitamin D. Low levels of vitamin D have been associated with~     higher rates of death, heart and blood vessel disease, osteoporosis, falls, cancer, and~     autoimmune diseases. Despite this, there is a lack of randomized controlled trials (RCT)~     examining the effects of nutritional vitamin D in hemodialysis (HD) patients. The~     investigators hypothesize that long-term supplementation with nutritional vitamin D in HD~     patients improves survival and cardiovascular outcomes. Before embarking on a large scale~     RCT, the investigators propose a small pilot RCT with 20 hemodialysis patients to: i) To~     determine the effects of cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii)~     To determine the feasibility and barriers to successful randomization and adherence to~     treatment protocols, which will inform subsequent studies.~   "
140564|NCT01214915|"~     The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide~     Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's~     previously treatment has either not been effective or has caused unacceptable adverse~     reactions. The study will aim to show that platelet counts can be safely reduced in treated~     patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an~     positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.~   "
140565|NCT01214902|"~     The research objectives are to test the efficacy of a Modified CIMT treatment in babies~     diagnosed with hemiplegia, treated in a home program, as compared to a control group of~     babies receiving a parallel home program but with no CIMT.~   "
140566|NCT01214889|"~     This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine~     versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.~      Primary Objective:~      To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,~     Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to~     acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's~     TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the~     three-dose primary vaccination.~   "
140567|NCT01214876|"~     A longitudinal study on immune responses in relation to protection against clinical malaria~     episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited:~     children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25~     and above (n=125). After finger prick sampling (~300µL) and examination at enrolment,~     participants will be followed up for one year. Follow-up will include fortnightly active~     case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the~     associated clinical and parasitological parameters will be related to immunological profiles~     determined utilizing a protein microarray as a capture substratum to profile the humoral~     immune response against a vast number of parasite antigens.~      For individuals who experience a clinical malaria attack or who are diagnosed with high~     density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood~     sample is obtained to determine the diversity of parasite antigens in the population in~     relation to antigen recognition in the cohort.~   "
140568|NCT01214863|"~     This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric~     Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.~   "
140569|NCT01214850|"~     The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal~     vaccines on carriage of Neisseria meningitidis in a young adult population.~   "
140570|NCT01214837|"~     The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant~     vaccination schedule including kinetics of immune response in the early phases of the~     series.~   "
140571|NCT01214824|"~     To demonstrate that in patients with persistent poorly controlled diabetes,~     short/intermittent use of continuous glucose monitoring can driver better longer-term~     glycaemic control and HbA1c.~   "
140572|NCT01214811|"~     The purpose of this study is to evaluate the change in signs of inflammation/local infection~     when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers~     (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of~     topical antimicrobial treatment according to the physician.~   "
140573|NCT01214798|"~     Traumatic sesamoid displacement of the first metacarpophalangeal joint can affect thumb~     function.~   "
140574|NCT01214785|"~     The study is a cluster-randomized, controlled trial conducted among 100 villages (including~     approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India.~     The study aims to assess the impact of the construction and use of latrines in rural~     settings on diarrhoeal disease, helminth infections and nutritional status. The study will~     also report on the cost and cost-effectiveness of the intervention and its impact on lost~     days at school and work as well as on expenditures on drugs and medical treatment. The study~     will document how the intervention actually impacts exposure to human excreta along~     principal transmission pathways by evaluating the impact on (i) faecal contamination of~     drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas,~     and (iii) the presence of faeces in and around participating households and villages. The~     study will also explore the extent to which different levels of acquisition and use of~     on-site sanitation among householders impact disease throughout the community.~   "
140591|NCT01214564|"~     This study is primarily designed to investigate whether treatment, once daily for up to~     three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable~     in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to~     investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive~     days to Seborrhoeic Keratosis on non-head locations.~   "
140592|NCT01214551|"~     The purpose of this study is to increase the knowledge of the possible diagnostic effect of~     exercise induced bronchoconstriction performing a repeated exercise challenge test.~   "
140593|NCT01214538|"~     This clinical study is designed to assess prospectively the sero-responses to various~     proteins in cases of pneumococcal Acute Otitis Media.~   "
140575|NCT01214772|"~     Embryo transfer failure is defined as ≥3 IVF-embryo transfer failures without pregnancy . In~     spite of transfer of 3 good quality embryos , just 20-30% of women undergoing IVF will~     achieve ongoing pregnancy . There are multiple factors that influence IVF-failure.~      Autoantibodies may be one of the possible causes of IVF-failure , especially in unexplained~     and mechanical infertility .~      In some studies , antiphospholipid antibody is considered as causative factor on~     implantation and embryo failure. However some investigators showed that combination therapy~     with heparin/aspirin in women with positive antiphospholipid antibody is not effective in~     improving of IVF-outcome . In prospective studies were not confirmed association between~     antiphospholipid antibody abnormalities and IVF-failure.~      Recently has been relationship between thrombophilia and IVF and implantation failure.~      The effect of unfractionated heparin in assisted reproductive technology (ART) cycles is~     prevention of thrombosis in implantation site . Although its effect is not restricted to~     anticoagulation and also can modulate apposition , adhesion , and penetration of embryo .~     Other advantages are decreasing thrombophilic risk in COH ( controlled ovarian~     hyperstimulation) cycles with administration of gonadotrophins . So heparin make better~     pregnancy rate in repeated IVF-ET failures.~      There are few studies in regard to heparin effects on IVF cycles outcome . The purpose of~     this study is evaluation of unfractionated heparin effects on improvement of ART outcome .~      This study was a prospective randomized controlled trial to assess whether administration of~     heparin would increased pregnancy rates in women with repeated ET-IVF failures.~   "
140576|NCT01214759|"~     This study will evaluate the safety and tolerability of the combination of truvada and~     raltegravir given for 28 days for the prevention of HIV infection.~   "
140577|NCT01214746|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in healthy man.~   "
140578|NCT01214733|"~     This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra~     (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in~     patients with moderate to severe rheumatoid arthritis. Patients who successfully completed~     studies WA17823 and WA18696 in South Africa are eligible to participate in this study.~     Patients will be allowed DMARDs according to the treatment they received in the previous~     studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The~     anticipated time on study treatment is 104 weeks.~   "
140579|NCT01214720|"~     This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added~     to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated~     time of study treatment is until confirmed evidence of disease progression, and the target~     sample size is 500+ individuals.~   "
140580|NCT01214707|"~     Characterization of the cardiac response (ECG) preceding an epileptic seizure.~   "
140581|NCT01214694|"~     The purpose of this study is to test two on-line interventions for families of young~     children who have experienced moderate or severe traumatic brain injury (TBI). This project~     builds upon the investigators' previous research by modifying the online intervention~     content to address the needs of young children with TBI. The goal of this project is to~     develop an intervention that will encourage positive parenting behaviors, improve child~     behaviors, and reduce parent distress and burden following TBI. The investigators~     hypothesize that the intervention groups will exhibit more effective parenting skills as~     well as better child functioning and lower levels of parental distress at follow-up than~     will the active comparison group.~   "
140582|NCT01214681|"~     Colorectal cancer is a common disease worldwide. It is now thought that colorectal cancer~     cells arise from stem cells where the genetic material regulating growth and division of the~     stem cell has become defective. This leads to unregulated production of cells which in turn~     have defective genetic information and cancer formation.~      Research into colorectal cancer is hampered by the fact that studies must take a very long~     time to produce results and be very large if the development of a cancer is the endpoint.~     Therefore alternative methods of quantifying the risk of developing a cancer are required so~     trials can be a realistic size and be completed in a realistic time frame. The investigators~     have previously identified several candidates for these 'biomarkers'. The next stage in~     proving or disproving these as useful biomarkers is to test their response to a dietary~     agent that the investigators know reduces the risk of colon cancer.~   "
140583|NCT01214668|"~     The goal of this study is to determine the dose of LY573636 that can be administered safely~     in combination with liposomal doxorubicin in patients with advanced cancer who have failed a~     prior treatment.~      The study consists of a dose escalation phase to the maximum tolerated dose (MTD)and a dose~     confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or~     primary peritoneal cancer who have never been treated with doxorubicin.~   "
140584|NCT01214655|"~     This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient~     dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355~     that can be safely administered to patients with acute leukemia. Part A and Part B are dose~     escalation of two schedules in patients with acute leukemia. Parts A and B will enroll~     concurrently. Part C is a dose expansion for each schedule in patients with acute~     myeloblastic leukemia (AML).~   "
140585|NCT01214642|"~     This study is being conducted to determine the safety of LY2523355 for the treatment of~     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).~   "
140586|NCT01214629|"~     This study is being conducted to determine the safety of LY2523355 for the treatment of~     advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).~   "
140587|NCT01214616|"~     -  To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with~          vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);~        -  To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics~          of afatinib and vinorelbine i.v.~   "
140588|NCT01214603|"~     Study JWYB is a multicenter, non-randomized, open-label, Phase 2 study of intravenous~     LY2090314 in participants with acute leukemia.~   "
140595|NCT01214512|"~     This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying~     colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect~     CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative~     of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and~     cancer).~   "
140596|NCT01214499|"~     Coronary disease is one of the most frequent pathology of the modern world and the leading~     cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous~     intervention and more than 5.000 coronary artery bypass graft (CABG) procedures are~     performed every year. Despite this data about 12% of patients have diffuse coronary disease~     and are not candidates to conventional therapies. Also between 15-25% of patients undergoing~     coronary bypass grafting receive an incomplete revascularization due to the poor quality of~     the coronary vessels.~      Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create~     channels through the myocardial, so this laser stimulates local angiogenesis and provides~     blood in the ischemic area. Results of this procedure have shown clear benefits in terms of~     reduction of angina and increase of survival of patients, compared to medical treatment.~      Cell therapy in heart disease is offering in recent years encouraging results despite the~     methodological difficulties that being able to use this technique sometimes involves. The~     basis lies in the potential ability of stem cells to differentiate into any type of adult~     cell. In the case of cardiac cell therapy, stem cells can differentiate into myocardial~     cells or vascular cells capable of developing angiogenesis. Further studies are needed to~     draw firm conclusions about the clinical impact that the use of stem cells has on~     cardiovascular disease.~      Recently a system has been developed to create, at the same time and in a simple and~     effective way, the laser channels and the introduction of stem cells on the edges of these~     channels. This system called PHOENIX ™ consists of a laser probe capable of creating~     transmural channels in the myocardium.~      Based on the what has just been explained, it is quite possible that the combination of both~     therapies can increase successful results regarding the reduction in angina these patients~     need. Initially, and after having some experience with this type of treatment, the results~     could be analyzed and compared with the results obtained through laser therapy, with the~     help of a controlled clinical trial, such as the one the investigators are proposing.~   "
140597|NCT01214486|"~     The primary purpose of this study is to analyze and compare plasma and intracellular~     concentrations of Raltegravir (RAL) in blood plasma and in peripheral blood mononuclear~     cells, using high performance liquid chromatography (HPLC).~   "
140598|NCT01214473|"~     Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and~     mortality in the newborn period around the world. India, with one of the world's largest~     populations, continues to struggle with extremely high infant and neonatal mortality rates.~     Sepsis accounts for 50% of deaths among community born (and 20% of mortality among~     hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial~     resistance, which is increasingly restricting the therapeutic options for medical care~     providers. Friendly bacteria called Probiotics have been used in multiple infectious and~     inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in~     many fruits and vegetables and also in human breast milk. These sugars reach the colon~     undigested and serve as food for the friendly bacteria. The current study uses a probiotic~     preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to~     prevent neonatal infections. Currently no conclusive data are available on the utility of~     probiotics in such conditions. If successful, such inexpensive preventive therapy can be~     made available to general public in resource poor countries. Similar preparations can also~     be used in the western world to prevent similar infectious conditions of the neonatal~     period, especially in preterm infants where sepsis continues to be a major cause of hospital~     stay and death.~   "
140599|NCT01214460|"~     Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest~     or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or~     EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes~     like cardiac arrest or transfer to intensive care unit. The aims of this study are to record~     and analyze the effects of EMS and department of emergency and both afferent and efferent~     limbs of MET activity in Finnish tertiary Hospital.~   "
140600|NCT01214447|"~     This prospective observational study is planned to validate OSND against the prospective~     morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that~     OSND risk stratification of chronic HD patients is useful in predicting outcomes and better~     than its component alone or in diverse combinations. The investigators specific aim is to~     validate OSND in chronic HD patients by comparing it with conventional measures of~     nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance~     analysis and several measures of clinical outcome including prospective mortality and~     hospitalization.~   "
140601|NCT01214434|"~     The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream~     in cradle cap.~   "
140602|NCT01214421|"~     To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from~     baseline (from trial 156-04-251) in total kidney volume (TKV) and renal function.~   "
140603|NCT01214408|"~     This prospective, open label, single-center and non-comparative study is designed to~     generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid~     inhibition effect in patients suffering from acid peptic disorders.~   "
140604|NCT01214395|"~     This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent~     infections in patients that need renal dialysis. A maximum of fifty subjects will be~     recruited and will be assessed for signs of infection once per week for the first 6 weeks~     and then every 4 weeks until week 26. They will also be checked for nasal carriage of~     'Golden Staph' when they enroll in the trial. The subjects will complete the trial if they~     have 26 weeks infection-free or if they have an infection during that period~   "
140605|NCT01214382|"~     This study is being conducted to evaluate how the body absorbs and processes the medication~     sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric~     bypass surgery. Participants will be asked to take part in this study at three time points:~     1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve~     months following surgery. This study will enroll approximately 30 participants.~   "
140606|NCT01214369|"~     -  Hypothesis:~             -  X-tip intraosseous is an effective supplementary injection in mandibular hot teeth~               as well as Periodontal Ligament (PDL) injection~        -  Purposes:~             -  Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in~               mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar~               Nerve Block~        -  Methods and Materials:~             -  forty patients with mandibular hot molar or second premolar which had not been~               anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected~               for this study~   "
140607|NCT01214356|"~     This purpose of this project is to evaluate the effectiveness of vitamin D supplementation~     over 12 months in vitamin D deficient African American adults with type 2 diabetes.~   "
140609|NCT01214330|"~     The purpose of this study is to see if it is possible to conduct a full study to determine~     whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed~     Pap test in detecting precancerous cervical lesions in females.~      Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.~   "
140610|NCT01214317|"~     The purpose of this study is to compare the effect of combinative induction therapy with~     mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of~     aggressive multiple sclerosis~   "
140611|NCT01214304|"~     The purpose of this study is to determine whether aromatherapy with lavender oil compared to~     placebo lowers anxiety levels in women during colposcopy.~   "
140612|NCT01214291|"~     The purpose of this study is to determine whether Toremifene Citrate is effective in~     reducing the risk of bone fractures in men with prostate cancer who are on Androgen~     Deprivation Therapy.~   "
140613|NCT01214278|"~     The aim of this study is to examine differences in short term bioavailability between four~     n-3 FA formulations in healthy males.~   "
140614|NCT01214265|"~     To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior~     tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented~     overactive bladder.~   "
140615|NCT01214252|"~     To evaluate short, mid and long term clinical outcomes associated with the use of Permacol~     in the treatment of abdominal wall defects.~   "
140616|NCT01214239|"~     In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of~     Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of~     treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic~     control.~   "
140617|NCT01214226|"~     The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for~     clinicians involved in the management of severe alcoholic liver disease. In patients with~     Maddrey function higher than 32, compelling evidence from data has shown that~     corticosteroids improve short-term survival. However, novel strategies or molecules are~     required in light of the fact that approximately 40 % of patients continue to die at 6~     months. A double-blinded randomized controlled trial of 101 patients has showed that~     Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In~     terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal~     function whereas corticosteroids induce an early improvement in liver function. When~     considering these differences of mechanisms, many clinicians suggest that the addition of~     pentoxyfilline to corticosteroids is an attractive option that needs to be tested in~     patients with severe AH.~   "
140618|NCT01214213|"~     There is evidence for altered muscle activity patterns in individuals with non-specific~     chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur~     and how they may be linked to pain experience and to the development of CNSBP. The main~     objective of this study is to investigate the spatial aspects of muscle activation in~     relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel~     surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental~     mechanisms related to motor control and fatigue/endurance. In this project data from healthy~     persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be~     compared to healthy persons. To minimize heterogeneity between groups the subject's age~     range will be from 30 - 50 years. The investigators main hypothesis is that motor control~     mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals,~     explaining the reduced tolerance for static postures. There has been little investigation of~     the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex~     organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG~     grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate~     motor control mechanisms in this region, and further the investigators understanding of~     neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will~     lead us to new insight and new strategies for the treatment of back pain.~   "
140619|NCT01214200|"~     The purpose of this pilot study is to evaluate the effect of high intensity non-invasive~     positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The~     investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will~     benefit the stable hypercapnic COPD patient through a reduction in the daytime partial~     pressure of carbon dioxide in arterial blood (PaCO2) levels.~   "
140620|NCT01214187|"~     The purpose of this study is to determine whether low concentration inhaled carbon monoxide~     is effective in treating idiopathic pulmonary fibrosis.~   "
140621|NCT01214174|"~     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular~     inflammation after cataract surgery.~   "
140622|NCT01214161|"~     The intrauterine device (IUD) is a form of birth control that is extremely effective and~     safe, even in women who have not yet had children. Women can experience high levels of pain~     when the IUD is placed inside the uterus, and fear of this pain could be a reason that women~     decide not to use this method.~      This study will randomly (like flipping a coin) assign women who have chosen the IUD as~     their contraceptive into two groups. One group will have lidocaine anesthetic gel placed~     into their cervix prior to having the IUD inserted; the other will have an inert gel placed~     into their cervix instead. The level of pain at three different time points on a 10cm scale~     and the patient's satisfaction with the procedure will be compared between the two groups to~     see if using lidocaine gel helps decrease IUD insertional pain~   "
140623|NCT01214148|"~     A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2~     centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to~     determine the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15~     patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional~     clinical follow-ups take place at 1 month and yearly up to three (3) years.~      The objective of this trial is to assess the safety and clinical performance of the ORSIRO~     drug eluting stent in patients with single de-novo coronary artery lesions.~   "
140624|NCT01214135|"~     The primary objective of this non-interventional study is to investigate how Seroquel XR and~     Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be~     done by a retrospective review of medical records to evaluate patients treated with Seroquel~     XR or Seroquel IR as primary antipsychotic treatment.~   "
140626|NCT01214109|"~     To establish bioequivalence at steady state of:~      1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg~     pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended~     release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet~     t.i.d. in fasted status~      To investigate dose proportionality of pharmacokinetics parameters for:~      1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.~   "
140627|NCT01214096|"~     Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous~     Administration in Patients With Chronic Systolic Heart Failure~   "
140628|NCT01214083|"~     The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine +~     high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in~     reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than~     low-dose naltrexone (50 mg) alone in reducing alcohol drinking.~   "
140629|NCT01214070|"~     The objective of this study is to test functional vision outcome measures that reflect the~     loss in everyday life tasks that require vision and that are sensitive to changes after a~     course of vision rehabilitation in Veterans/participants with TBI.~   "
140630|NCT01214057|"~     The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia~     in endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding~     during surgery, duration of surgery, blood flow to the nose and other parameters. The~     investigators hypothesize that total intravenous anesthesia decreases bleeding and improves~     the view during surgery.~   "
140631|NCT01214044|"~     The goal of the study is to obtain preliminary data that will test whether the~     antidepressant medication escitalopram resets the body clock: a collection of nerve cells in~     the brain that control the timing of many body processes. The study will also test whether~     the improvement in depression symptoms with escitalopram correlates with the degree to which~     the timing of the body clock is properly aligned with the timing of sleep.~   "
140632|NCT01214031|"~     Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with~     magnification has been utilized for polyp histology identification. Pit patterns on the~     surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy~     in differentiating the polyp types (18, 19). NBI, that is also referred to as electronic~     chromoendoscopy is another technique that has been evaluated for polyp histology~     identification by highlighting the superficial mucosal and vascular architecture (15, 20,~     21). pCLE is another novel addition to the technologies aiming to accomplish in vivo~     histologic diagnosis with a high degree of accuracy. The pCLE system has three major~     components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made~     of approximately thirty thousand optical fibers bundled together and terminated by a distal~     microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10~     µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The~     miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any~     standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm)~     that combines the functions of laser light illumination and rapid laser scanning, enabling a~     frame rate up to 12 images per second and signal detection. The third is the control and~     acquisition software for real time image reconstruction, immediate sequences display and~     post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is~     identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is~     passed through the accessory channel of the endoscope and placed against the lesion to~     obtain several high-quality images and video sequences. In a study by Buchner et al from the~     Mayo Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37~     polyps from 25 patients in a blinded fashion without the knowledge of their histologic~     diagnosis or endoscopic appearance. The investigators developed the following criteria that~     were suggestive of neoplastic polyps: villiform pattern, nuclear characteristics -~     oval/irregular nuclear shape and increased number of nuclei. These features had a~     sensitivity of 82.6%, specificity of 92.9% and accuracy of 86.5% for the characterization of~     neoplastic polyps. Similarly, Meining et al (23) have also evaluated criteria for~     differentiating neoplastic from benign lesions in the colon with encouraging results.~      The investigators hypothesize that pCLE will have a high rate for accurate characterization~     of polyp histology real time during colonoscopy~   "
140633|NCT01214018|"~     The goal is to compare post tramautic stress between the nearest relatives of brain-dead~     patients who are organ donor to those of brain-dead patients who are not organ donors for~     medical, legal or opposition reasons.~   "
140634|NCT01214005|"~     This project tests two hypotheses concerning the low smoking cessation rates in smokers with~     schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger~     and more sustained effects of smoking abstinence on negative mood and smoking urge than~     control smokers without psychiatric illness. The second hypothesis is that smokers with~     schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more~     rewarding effects of smoking after a period of abstinence) than control smokers without~     psychiatric illness.~   "
140635|NCT01213992|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500~     mg and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney~     Disease.~   "
140636|NCT01213979|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500~     mg and 1000 mg) of Monofer(R)in patients suffering from non-hematological malignancies with~     Chemotherapy induced anaemia.~   "
140637|NCT01213966|"~     A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical~     Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in~     adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria~     mono-infection.~   "
140638|NCT01213953|"~     The study is designed for evaluating the presence of mesenchymal stem cells of vertebral~     disc. Isolation and authentication of these cells may be applied for the vertebral disc~     regeneration and the research tissue engineering.~   "
140639|NCT01213940|"~     Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies~     and in the number of circulating functional replicative competent endothelial progenitor~     cells (EPC's) after bariatric surgery.~   "
140665|NCT01213602|"~     The principal objective is to notice the relevance of timing performance of femoral block~     for knee replacement surgery during general anesthesia and analyze the relationship with~     bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia.~     Otherwise the investigators try to investigate if the timing of performance of this block~     influence in postoperative variables as pain or blood loss.~   "
140666|NCT01213589|"~     The purpose of this post-market release registry is to collect additional information~     concerning safety, performance and health economic data with respect to the Medtronic~     VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of~     descending thoracic aortic dissections.~   "
141381|NCT01204229|"~     In the proposed project the investigators will develop and test a novel brief intervention~     targeting college students who drink heavily to cope with anxiety and depression, a behavior~     that increases risk for the development of alcohol dependence.~   "
140640|NCT01213927|"~     Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is~     increasing in developed countries and is the leading cause of death in patients with~     cirrhosis. The diagnosis and the early management are key issues that could improve the~     prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology~     of underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and~     Japan, and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved~     results of anti-viral therapies, this trend should be reinforced with a decreasing~     proportion of HCC related to viral cirrhosis and an increasing proportion of HCC related to~     alcoholic cirrhosis. However, natural history of alcoholic cirrhosis remains poorly~     understood, most studies being retrospective and including a small number of patients. This~     project is filed by the consortium CIRRAL including French Academic hospitals centers~     currently involved and referees in the field of alcoholic liver disease and HCC (8 at the~     moment, and more in the next months). It is a national multicenter prospective study that~     will include 1200 patients with alcoholic cirrhosis histologically proven over 3 years. The~     main goal of this cohort is to describe the natural history of a large number of patients~     with alcoholic cirrhosis prospectively followed, and to identify predictors of the~     occurrence of HCC.~   "
140641|NCT01213914|"~     The purpose of this study is determine if High-Volume Hemofiltration in addition to~     'contemporary' care will result in an improvement of select clinical outcomes when compared~     to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary~     to septic shock.~   "
140642|NCT01213901|"~     To determine which anatomic site offers the most consistent (superior) absorption of~     insulin.~      To determine the injection technique which allows the most consistent subcutaneous injection~     of insulin (to pinch or to spread).~      Hypothesis:~      Based on age-related changes in the amount of subcutaneous fat we anticipate that the~     absorption of insulin from various anatomical sites will differ.~      Justification:~      To date health care professionals have extrapolated data obtained from younger adults and~     applied the results to the elderly.~      Objectives:~      To determine the rate of insulin absorption from different anatomic sites in diabetic~     patients over the age of 70.~      To determine the best practice for subcutaneous injection in older adults.~      Research Method:~      Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.~      Statistical Analysis:~      Paired t test, repeated measures ANOVA~   "
140643|NCT01213888|"~     To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal~     photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy.~     Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following~     the administration of pan-retinal photocoagulation therapy for severe non-proliferative~     diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in~     less macular edema and improved visual outcomes.~   "
140644|NCT01213875|"~     The home based intervention is a multidisciplinary approach that has shown benefit in the~     follow-up of patients with Heart Failure (HF). It is considered one of the most effective~     approaches and humanized by education and care for the patient in his environment of~     routine. In this study the monitoring of HF patients in the home after hospital discharge~     will include the reinforcement, monitoring and reassessment of previously provided guidance~     on the disease and self-care, compliance to prescribed medications and especially the early~     recognition of signs and symptoms of decompensation by patients and their caregivers.~   "
140645|NCT01213862|"~     Home visits (HV) are one of the multidisciplinary approaches that has already shown to~     benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most~     effective and humane approaches as it educates and takes care of the patient in his/her~     routine environment. In this study, the follow-up of HF patients in a home setting after~     being discharged from hospital will include the reinforcement, monitoring and re-evaluation~     of guidelines previously provided about the disease and self-care, compliance to prescribed~     medicines and, specially, the early recognition of decompensation signs and symptoms by~     patients and their caregivers.~   "
140646|NCT01213849|"~     The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF)~     and equivalence of vilanterol (VI)following single dose administration of FF/VI via the~     novel dry powder inhaler in healthy subjects.~   "
140647|NCT01213836|"~     This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised~     crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on~     cognitive performance in patients with schizophrenia stabilized on a single antipsychotic~     medication.~   "
140648|NCT01213823|"~     The purpose of this study is to estimate the relative risk of severe hepatic injury in~     hospitalized patients with invasive candidiasis and candidemia who received anidulafungin,~     compared to patients who received caspofungin and/or micafungin.~   "
140649|NCT01213810|"~     The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive~     individuals. Study participants are stratified into different patient groups according to~     their CD4 cell count, viral load and HIV Status.~        -  Trial with medicinal product~        -  Trial with immunomodulatory product / biological~   "
140650|NCT01213797|"~     With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an~     important public health problem. For each death by suicide, one can count 6 direct~     bereaved people and 20 people in more indirect connection with this mourning (Terra 2001).~     In term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide~     and 3.750.000 people (annually) touched by the suicide attempt of a close relative. It~     seems indeed important to have Public Health data on this cascade repercussion of the~     suicide attempt.~      A suicide attempt propagates a suffering cascade on the various circles of the family and~     close entourage, which can be measured in term of traumatic stress and medico-economic~     impact.~      Objective = To measure the medico-economic impact on the entourage, in the 3 months~     following the suicide attempt and at 1 year.~   "
140651|NCT01213784|"~     The investigators wish to investigate wether a more strict diabetic control improves cardiac~     function, muscle strength, exercise capacity and decreases symptoms.~      The investigators hypothesis is that improving the glycemic control in suboptimized~     diabetics with heart failure will improve cardiac performance, muscle strength, exercise~     capacity and decrease symptoms.~   "
140652|NCT01213771|"~     Background Denmark has a record-high incidence of, and mortality rate for, ovarian cancer.~     There are 600 new cases of ovarian cancer each year. In 2008 the state issued a guarantee of~     early diagnosis and treatment of all cases of suspected cancer, and surgical treatment has~     been centralised and standardised in fast track programmes. However, the investigators do~     not know how women with ovarian cancer experience the period prior to surgery and how they~     can optimally prepare for treatment and care.~      Aim The two principal aims of the study are to describe health and coping in Danish women~     surgically treated for ovarian cancer; and to examine to what extent it is possible, from~     both a patient and professional perspective, to improve the health and everyday life of~     patients with ovarian cancer.~      Materials and methods The study is conducted within the scientific theoretical framework of~     hermeneutics, involving the overall concepts of health promotion and rehabilitation. The~     study will be carried out in 4 stages between September 2008 and September 2011. Stage 1: A~     health-related characterisation of Danish women with ovarian cancer through a registration~     process. Stage 2: Qualitative research interviews with patients, to gain knowledge about~     spontaneous preoperative coping strategies and resources.~      Stage 3: The preoperative preparation programme will be developed and clinically tested. The~     effect of participation will be measured by self-assessed health and coping before and after~     surgery. The study period runs from the time the decision is taken to operate until eight~     weeks after discharge. The study takes place at the Department of Gynaecology at Aarhus~     University Hospital, Skejby in Denmark, which is a regional centre of surgical treatment of~     gynaecological cancer.~      Results The study provides insight into the preoperative coping strategies and general~     health of Danish women suffering from ovarian cancer. The development and testing of the~     preoperative preparation programme contributes to knowledge about optimisation of~     preoperative preparation. This might have a positive impact on the participants' general~     health and level of functioning during their treatment. Furthermore, the project contributes~     to knowledge of the preoperative coping strategies and experiences of (female) cancer~     patients in general.~   "
140653|NCT01213758|"~     Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the~     galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This~     technique provides volumetric mapping of liver function and it allows quantisation of liver~     function. The method may be used for selection of patients for stereotactic radiotherapy of~     liver tumors, for determination of radiation induced liver dysfunction and may be included~     into the treatment planning process of stereotactic radiotherapy.~   "
140654|NCT01213745|"~     This study will investigate the effectiveness of using the European Organisation for~     Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13)~     to identify and target therapies in patients with lung cancer. The study will assess whether~     using the questionnaire will result in an improvement in QoL.~   "
140655|NCT01213732|"~     In this study the recombinant human fusion protein L19TNFα will be associated in ILP with~     the standard treatment with melphalan 10mg/l limb volume in subjects affected by stage~     III/IV limb melanoma.~      The recombinant human fusion protein L19TNFα was created with the intention to target TNFα~     directly to tumor tissues with the result in high and sustained intralesional bioactive TNFα~     concentrations.~   "
140656|NCT01213719|"~     It has been suggested that betaine supplementation may improve muscle strength by increasing~     muscle creatine content. However, there is no data supporting this assumption. The~     investigators speculate that betaine supplementation could enhance intramuscular creatine~     content, which would result in strength improvements.~   "
140657|NCT01213706|"~     In the present proposal the investigators wish to assess the effect of a single session with~     the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on~     baseline airway blood flow (Qaw) and in Qaw variation, in current smokers,~     glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation~     that the treatment will transiently increase the Qaw, and to a greater extent in the current~     smokers and patients with asthma who have endothelial dysfunction.~   "
140658|NCT01213693|"~     Exacerbations are important events in the natural history of chronic obstructive pulmonary~     disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that~     exacerbations negatively affect the natural history of the disease; e.g. lung function~     decline is accelerated in patients with frequent exacerbations. Bacteria are considered the~     most relevant cause of exacerbations, but there is evidence that viral infections are~     equally contributing.~      Either alone or in combination with viruses, airway bacterial load in stable COPD correlates~     with both the frequency of exacerbations and the decline in lung function.~      A long-term clinical trial recently showed that the regular treatment with inhaled~     corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it~     reduces the frequency of acute COPD exacerbations in COPD.~      In a recent study it was found that airway bacterial load increases over time (1 yr follow~     up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.~      This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral~     and/or bacterial load in the sputum of COPD patients.~   "
140659|NCT01213680|"~     The purpose of this study is to assess the pharmakokinetic properties of higher doses (500~     mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease~   "
140660|NCT01213667|"~     To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF~     treatment of exudative age-related macular degeneration. Also to assess necessity and~     frequency of pro re nate medical re-treatment.~   "
140661|NCT01213654|"~     A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS~     lobectomy.~   "
140662|NCT01213641|"~     The purpose of this observational study is to collect additional information regarding~     long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical~     practice.~   "
140663|NCT01213628|"~     Eighty adult patients undergoing open colon surgery will be randomized to either:standard~     warming measures or to additional insufflation of humidified carbon dioxide in the open~     wound cavity during major abdominal surgery.~      PRIMARY AIM is to test if core and local temperature can be increased.~   "
140664|NCT01213615|"~     Since the first implant in September 1982, the Medtronic Hancock® II has provided more than~     20 years of excellent hemodynamic performance and durability. Design improvements over the~     past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6~     anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant~     system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in~     obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A~     critical issue is the size of the prosthesis in relation to the patient's annulus.~      The objective of this clinical study is to evaluate, at six and twelve months, the~     hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to~     analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to~     ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus~     diameter.~   "
140667|NCT01213576|"~     Albendazole and ivermectin are currently used in combination for annual mass treatment of~     lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such~     programmes is very high and has proven to be a major impediment to the success of programmes~     in many countries with limited financial resources.~      Data from albendazole treatment of other filarial infections and one study comparing single~     to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased~     dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae.~     It is essential to determine whether such higher doses are indeed beneficial since this~     could have far-reaching effects on the conduct and management of the main mass treatment~     programmes and also in the management of programmes as they near elimination.~   "
140668|NCT01213563|"~     Gastric bypass surgery has been proposed as an effective treatment strategy for type 2~     diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately~     after surgery have not been established. The investigators designed an algorithm to achieve~     good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric~     bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.~   "
140669|NCT01213550|"~     The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine~     mouthrinse on gingival inflammation and subgingival microbiota in addition to daily~     mechanical plaque control in a population with established gingivitis.~   "
140670|NCT01213537|"~     This study aims to investigate the effect of a pacemaker device used in heart failure~     patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the~     investigators aim to investigate if the CRT pacemaker has an effect on breathing stability~     in these patients and particularly breathing stability at night. Our theory is that the CRT~     pacemaker may improve the stability of breathing in patients with heart failure.~   "
140671|NCT01213524|"~     The objective of this study is to investigate the relative contributions of nicotine~     replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on~     abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms,~     cognitive task performance and smoking behavior in smokers with schizophrenia and~     non-psychiatric smokers.~   "
140672|NCT01213511|"~     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)~     extracorporeal circulation on neurocognitive function after elective coronary bypass~     grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion~     intraoperatively.~   "
140673|NCT01213498|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in patients witk chronic kidney disease.~   "
140674|NCT01213485|"~     This observational study will evaluate the course of treatment, the efficacy on anemia and~     the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic~     kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal~     dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating~     agents (ESA). Data will be collected from each patient for 12 months.~   "
140675|NCT01213472|"~     The purpose of this study is to investigate the safety, immunogenicity and clinical activity~     of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of~     patients with non-operable and progressing metastatic cutaneous melanoma.~   "
140676|NCT01213459|"~     This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the~     HPV type distribution among women >= 15 years of age, attending routine gynaecological~     examination in the Kingdom of Saudi Arabia.~   "
140677|NCT01213446|"~     This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety~     of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von~     Willebrand disease (VWD) in whom treatment with a VWF product is required for prophylactic~     therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or~     traumatic bleeding event.~   "
140678|NCT01213433|"~     This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of~     AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.~   "
140679|NCT01213420|"~     This study is a prospective, randomized controlled, double blinded, study in a multi centre~     setting. Three burn centres will include 60 patients in total.~      If suited for the study (= two equal donor sites) and after informed consent, patients will~     be observed starting the day of skin prelevation.~      A coded file will be made for each patient and these files should contain the localization~     of both donor sites, their depth as determined by the setting of the dermatome and the~     treatment. Treatment for both donor sites will always be equal.~      The date of wound healing of each donor site, which may only differ by a maximum of five~     days, will be noted. Digital photographs of the healed donor sites will be taken and the~     scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale~     prior to the start of hydration.~      From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while~     one of the control products will be applied to the second site. Per group of five patients~     per centre a different control product will be applied to the second donor site. The tubes~     containing these products will be colour and numerical coded. Nor the treating personnel,~     nor the patients will be informed which colour tubes contain the control products and which~     contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for~     one donor site, the garments will be applied for both sites.~      Follow-Ups will be performed on one, three and six months after wound closure. Objective~     methods will be used during these follow-ups to evaluate elasticity and colour of the scar,~     this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The~     evaporation, permeability and hydration of the scar will be measured by using the Tewameter®~     and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin.~     The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales~     for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have~     to be completed by the patient.~   "
140680|NCT01213407|"~     A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group~     receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group~     receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection~     of at least 70% in both groups. The hypothesis is based on the assumption that time to~     progression will be doubled in the treatment group.~   "
140718|NCT01212913|"~     Primary Objective:~      To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between~     the basal plus one and the biphasic insulin regimen.~      Secondary Objective:~      To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to~     comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic~     event is taken into account.~   "
140681|NCT01213394|"~     The purpose of this research study is to determine if adding or increasing the dose of~     CellCept while lowering the dose of tacrolimus (Prograf or Advagraf) or cyclosporine~     (Neoral), and/or steroids can reduce the likelihood of developing coronary heart disease in~     the next 10 years.~      The investigators will calculate the change in risk of developing coronary heart disease~     using the Framingham score. The Framingham score is a mathematical equation that includes~     the following information: Age, Gender, Diabetes status, Smoking status, Lipids, Blood~     Pressure. The Framingham score estimates how likely it is that someone will develop coronary~     heart disease over the next 10 years.~   "
140682|NCT01213381|"~     Primary Objective:~      - To determine a dose of SAR240550 to be further studied in combination with chemotherapy~     regimens~      Secondary Objectives:~        -  To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination~          with chemotherapy regimen (gemcitabine and carboplatin~        -  To assess safety profiles: significant laboratory changes and adverse events (AEs)~        -  To make a preliminary assessment of antitumor effect in study subjects per Response~          Evaluation Criteria in Solid Tumors (RECIST) with measurable disease~        -  To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and~          4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics~        -  To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell~     lines. Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
140683|NCT01213368|"~     Primary Objective:~      - To assess the efficacy of dronedarone versus placebo for the control of ventricular rate~     in patients with permanent Atrial Fibrillation (AF).~      Secondary Objective:~        -  To assess the safety and tolerability of dronedarone after repeated oral doses of 300~          mg, 400 mg, or 600 mg twice daily in the selected population.~        -  To document SR33589 and SR35021 trough plasma levels at steady state.~   "
140684|NCT01213355|"~     It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive~     impairments in healthy adults subjects.~   "
140685|NCT01213342|"~     Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease~     is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007),~     the investigators hypothesize that the omega-3 fatty acid supplements used in this study~     will help to improve dry eye signs, such as eye surface irritation (staining) and tear film~     osmolarity, which is an overall measure of tear film stability and dry eye status. Further,~     the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such~     as discomfort and burning, will also improve with supplementation.~   "
140686|NCT01213329|"~     The purpose of this study is to check the T and B cells of the immune system in 50 newly~     transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100~     anticipated participants). This will be done to see how the Standard of Care (SOC)~     anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H®~     reduces the number of T cells produced by one's body. We will look for these cells using a~     number of laboratory tests; It will require the subjects to each give 65mL of blood at each~     of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to~     participate in phase 2 depending on lab results.~      In phase 2, subjects will be randomized to one of the three following groups:~      Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)~      Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be~     continued at the same dosage.~      Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued~     at the same dosage.~      There will be an analysis of these cells at different time point, pre and post kidney~     transplant. The data collection will allow us to study the stability over time of particular~     phenotypes (cell structures) and T cell function. We will also evaluate how the two~     different minimizing protocols effect the cell structure. Results from laboratory testing~     may allow us to define certain criteria that can be broadly applied in solid organ~     transplant recipients. This may allow for safe reduction of the anti-rejection medication~     that transplant recipients receive.~   "
140687|NCT01213316|"~     This is an observational, non-comparative, multicenter, open-label study. Participants will~     be treated with Raltegravir according to standard clinical practice, and monitored over a~     total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging~     participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks.~     Participants who stop taking Raltegravir before the end of the 96-week period or 48-week~     period, respectively, will be followed up for 3 months after discontinuing the drug. The~     primary objective is to determine the proportion of participants with a human~     immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with~     Raltegravir.~   "
140688|NCT01213303|"~     Cardiovascular diseases belong to the major causes of mortality in western populations, and~     atherosclerosis is the lesion responsible for clinical events, such as acute myocardial~     infarction and stroke.~      Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical~     stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors~     for atherosclerosis are being recognized. Some of them are responsible for the~     epidemiologically very serious metabolic syndrome, which accounts for development of~     hyperlipidemia, obesity, diabetes or arterial hypertension.~      Health providers in continental diet-based countries suggest to embracing Mediterranean diet~     in order to contribute in reducing cardiovascular mortality. However, countries in the~     Mediterranean area are experiencing a shift in dietary habit towards continental diet with~     potential harmful change in mortality rates. Oxidative stress, including free radical-driven~     reactions and antioxidant status are considered important mediators to be considered in the~     diet-mediated effect on health. Important metabolic functions are also mediated by certain~     fatty acids. A comprehensive study of oxidative stress, including free radical-driven~     products and protective antioxidants, and fatty acids metabolism has never been reported in~     healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative~     stress and fatty acids metabolism are rarely applied to epidemiological studies.~      The aim of the present grant project is therefore to assess in a large cross-sectional study~     the prevalence of oxidative stress markers, and fatty acids and to find any causal relation~     between these variables and metabolic syndrome. This population sample will be followed~     prospectively not only for time of the present grant project, but we would like to study~     metabolic variables with relation to the development of oxidative stress-mediated diseases,~     in particular those of cardiovascular system, on a longitudinal basis (prospective~     epidemiological study for at least 10 years). At same time we should be able to define the~     importance of individual markers of oxidative stress and fatty acids for early detection of~     these diseases.~   "
140689|NCT01213290|"~     Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool~     in the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as~     mediastinal and intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left~     adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that~     can have tremendous impact on patient management. FNA is typically performed using a 22- or~     25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in~     place in the needle. After withdrawal of the stylet, the needle is moved to and fro within~     the lesion and this process is repeated for each needle pass. It is currently believed that~     the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of~     the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens~     obtained. However, there are no data demonstrating clearly that the use of a stylet improves~     the yield of EUS-FNA. The reason why this question is important is because the use of a~     stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of~     EUS-FNA needle systems.~      In this prospective randomized controlled trial, patients referred for EUS-FNA of~     mediastinal and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal~     mass and gastrointestinal submucosal tumors will be included. FNA will be performed with a~     22-gauge needle under EUS guidance using suction with a 10 mL syringe by two experienced~     endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in~     place or without a stylet for each FNA pass will be assigned by using a preprinted~     randomization scheme obtained from a sealed envelope and clearly documented. Each lesion~     will be sampled for a minimum of four needle passes. The pathologists providing the final~     interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree~     of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a~     positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs.~     EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value~     and negative predictive value of each technique when compared to the final diagnosis will be~     calculated. Inter-observer agreement among cytopathologists will be assessed for specimens~     obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.~   "
140690|NCT01213277|"~     HbA1c is used as a gold standard to see whether patients have optimal glycemic control.~     Today, many physicians rely solely on HbA1c to change medication. However, there is a select~     group of patients that have low average glucose levels but high HbA1c levels. The~     investigators believe that these patients are fast glycators meaning that they incorporate~     sugar into their hemoglobin faster than normal. The investigators want to determine whether~     these patients are fast glycators.~   "
140691|NCT01213264|"~     The intent of this observational study is to collect prospective data regarding~     neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value)~     during surgery, in countries of Central and Eastern Europe, Middle East and Africa~     (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures~     neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is~     a non-interventional clinical trial, and administration of NMBAs, and respective reversal~     agents, (as well as all drugs used during anesthesia) will be done in accordance with~     routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be~     monitored according to routine anesthesiology practice by means of acceleromyography. The~     assignment of the participant to a particular therapeutic strategy is not decided in advance~     by a trial protocol, but falls within current practice and the prescription of the medicine~     is clearly separated from the decision to include the patient in the study.~   "
140692|NCT01213251|"~     The purpose of this study is to demonstrate the feasibility of pacing as a therapy to~     prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI)~     in patients at highest risk for adverse myocardial remodeling.~   "
140693|NCT01213238|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to~     patients with advanced cancer that has spread to the liver. The safety of these drug~     combinations will also be studied.~   "
140694|NCT01213225|"~     Nursing home patients admitted to the hospital poses significant challenge for health care~     providers. Geriatric teaching pays particular attention to these admissions and related~     problems. However, it yet to be proven, that geriatric training helps to overcome any of~     them in better way then non-geriatric education. The study aims to prove that geriatric care~     provides advantages over non-geriatric training in caring for nursing home patients admitted~     to the hospital.~   "
140695|NCT01213212|"~     The study investigates whether a caloric restricted dietary regime can prevent onset and/or~     progression of chronic kidney disease in type 2 diabetic patients with abdominal obesity,~     through the amelioration of concomitant metabolic abnormalities such as insulin resistance,~     dyslipidemia, hypertension and inflammation, possible risk factors for the onset of kidney~     disease.~      The main aim of the study is therefore to evaluate the renoprotective effect of caloric~     restriction (CR) on subjects at risk of nephropathy. Secondary aim is to better understand~     how dietary implementation can modulate renal disease and its associated metabolic~     abnormalities.~   "
140696|NCT01213199|"~     The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the~     treatment of atrophic acne scars.~   "
140697|NCT01213186|"~     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually~     leads to clinically significant immunodeficiency. A chronic generalized immune activation is~     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1~     immunity and disease progression during chronic HIV-1 infection. However, it is still~     unknown whether reducing immune activation will restore CD4 T cell counts and leading to~     immune reconstitution in chronic HIV infection. Mesenchymal stem cells (MSC) have been~     demonstrated to decrease immune responses of the host, and can suppress inflammation in~     HIV-infected non-responders. Here, the investigators propose a hypothesis that MSC can~     reduce immune activation which subsequently lead to the restoration of CD4 T-cell counts~     dependent on dose of transfused MSCs in HIV-infected patients.~   "
140698|NCT01213173|"~     The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®)~     (95 - 190 mg) on heart rate in the Stable angina patients.~   "
140699|NCT01213160|"~     The primary purpose of this study is to explore the safety and tolerability of AZD4547 in~     Japanese patients with advanced solid malignancies.~   "
140715|NCT01212952|"~     RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by~     blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill~     more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose~     of bortezomib when given together with pomalidomide and dexamethasone and to see how well it~     works in treating patients with relapsed or refractory multiple myeloma.~   "
140748|NCT01212523|"~     The investigators hypothesize that there is no difference between the effects of isoflurane~     and propofol anaesthesia on pulmonary vascular resistance (PVR).~   "
140700|NCT01213147|"~     Despite the progression in assisted reproductive technology (ART), the preferred protocol~     for poor responders is still controversial. The management of poor responders consists of~     10% of ART cycles .~      The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level~     , number of obtained oocytes , and fertilization , implantation and pregnancy rates in~     patients with low ovarian reserve . Furthermore , bad quality embryos are observed in these~     women more than normoresponders and the increase of cancellation rate and doses of~     gonadotropin administration are remarkable results in poor responders . Several criteria~     have introduced for poor responders , the main defect in the management of them is lack of~     specific definition .Several strategies are available to improve ART cycles outcome in poor~     responders. These modalities include using : high FSH dose , stop GnRH-agonist protocol ,~     addition of growth hormone , transdermal testosterone , aromatase inhibitor ,~     GnRH-antagonist and recombinant FSH ( r-FSH) ; while the improvement of pregnancy rate has~     been quite low.~      The most common used protocol for ovarian stimulation is microdose GnRH-agonist flare in~     poor responders .Some investigators concluded that the use of GnRH-agonist  even in lower~     doses , led to prolonged stimulation and increased the cost without improving IVF outcome.~     Furthermore this method increased LH , progesterone and androgen of serum in follicular~     phase , which caused deleterious effect on follicular growth and oocyte quality .~      Clomiphene citrate co-treatment with gonadotropin and antagonist are one of the recommended~     protocol in poor responders . Clomiphene citrate increases endogenous FSH versus agonist in~     microdose protocol. Decreasing the doses of used gonadotropin and duration of stimulation~     are its beneficial effects in COH cycle .~      The aim of this study was comparing CC/gonadotropin/antagonist and GnRH agonist flare~     protocols on IVF outcome in poor responders .~   "
140701|NCT01213134|"~     Portfolios are the records of learning process, providing evidences of experiential~     learning. It can be a valuable tool not only for understanding the learning process but also~     for evaluating the accomplishment. Portfolios promote learners to reflecting, thinking,~     improving in learning as well as achieving learning goals. It has been widely applied in~     medical education. The goals of resident training outcomes in Wan-Fang Hospital are the~     ACGME six core competences. The Wan-Fang hospital, one of Taipei Medical University~     affiliated hospitals and the first implementing portfolio assessment teaching hospitals in~     Taiwan, will conduct portfolio assessment to assess residents competences. Facilitating~     residents bring reflective learning into practice, personal and professional growth and~     demonstrating the outcomes of training program. This study describes initiating and~     implementing portfolio assessment procedures. Qualitative and quantitative research methods~     are applied for evaluating the portfolio assessment process and the data of validity and~     reliability. Qualitative data collection methods of interview, focus groups and meetings~     will be used understanding the experiences and viewpoints of residents, mentors and~     assessors. Then quantitative data collection method of questionnaire will be subsequently~     used. The results of this study will provide experiences and suggestions for the~     implementation of portfolio assessment system in medical education.~   "
140702|NCT01213121|"~     -  To examine differences in neurophysiologic parameters between unmedicated patients with~          bipolar depression and healthy controls~        -  To examine within-subject changes in neurophysiologic parameters in patients with~          bipolar depression treated with quetiapine~   "
140703|NCT01213108|"~     The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of~     13-16 year old youths in regular parental meetings. The program aims to encourage parents to~     maintain a restrictive attitude towards youth drinking throughout their children's teenage~     years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study~     by the program developers showed a sustained alcohol-specific restrictivity among parents~     exposed to the program, and also a reduction on drinking measures among the youths of the~     exposed parents (Koutakis, Stattin & Kerr, 2008). This study aims to investigate whether~     these effects are sustained also when the program has gone into wide dissemination in~     Sweden.~   "
140704|NCT01213095|"~     The clinical efficacy of rituximab, a chimeric monoclonal antibody targeted toward the~     B-cell specific antigen CD20, was initially demonstrated in cases of follicular lymphoma~     (FL), but the use of this antibody has been extended over the last few years to the majority~     of subtypes of B-cell CD20 positive non-Hodgkin's lymphomas, with promising results thus~     far. In MZL, small numbers of case reports have chronicled the use of rituximab as a single~     agent or phase II trial combination with chemotherapeutic regimens.~      The results of the rituximab maintenance phase III trial demonstrated that patients with FL~     who continued to take rituximab monotherapy as a maintenance therapy after responding to an~     initial course of chemotherapy combined with or without rituximab experienced longer~     progression-free survival durations than did those who received no rituximab maintenance~     therapy. The efficacy of maintenance treatment after first-line induction treatment with~     R-chemotherapy was addressed in the international PRIMA (Primary Rituximab and Maintenance)~     study, which has enrolled 1,217 patients. The first results are eagerly awaited. Although~     MZL has better prognosis in TTP and OS than FL, both of them are classified as the same~     category of indolent lymphoma -characterized by frequent relapse and prolonged survival.~      According to the results of our survey, advanced stage MZL tends to be an indolent disease -~     characterized by prolonged survival with frequent relapses. Rituximab appears to contribute~     to better responses, but not in TTP. Thus, we should consider maintenance treatments for MZL~     patients, to extend their response duration.~   "
140705|NCT01213082|"~     The purpose of this study is to test the hypothesis that proton beam irradiation combined~     with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal~     anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.~   "
140706|NCT01213069|"~     The goal of this study is to evaluate the knowledge of paramedical and medical care~     personnel concerning organ and tissue donations, as well as their opinions on this activity.~   "
140716|NCT01212939|"~     When root canals of infected teeth with closed ends are cleaned, disinfected and filled, the~     results are predictable with excellent outcomes. However, in a tooth with incomplete root~     development, the end of the root(s) must be closed before filling the root canals. One or~     two-step artificial barrier using mineral trioxide aggregate (MTA) has been used before~     filling the root canals of these teeth. Despite the high success of this treatment, this~     procedure does not result in complete root formation and these teeth are susceptible to root~     fracture. A number of case reports in scientific journal have shown the possibility for~     regeneration of nerve within the root canal space and continued root development in teeth~     with dead nerves and open ends. There is very little information regarding the use of stem~     cells and growth factors from the blood of patients to regenerate the nerves in these teeth.~     Platelet rich plasma (PRP) from whole blood has been mentioned in the literature as a~     potential ideal material for regeneration of nerves in these teeth. The purpose of this~     study is to investigate the use of PRP to regenerate tooth nerve and close the root ends in~     teeth with root canal infection and open root ends.~   "
140707|NCT01213056|"~     The literature on the efficacy of Cognitive Behavioral Therapy (CBT) for the treatment of~     chronic pain is well established. Support for the efficacy of Mindfulness Based Stress~     Reduction (MBSR) and other mindfulness based treatments for chronic pain is building.~     Recently, research has demonstrated the efficacy of Mindfulness Based Cognitive Therapy~     (MBCT) in simultaneously addressing the outcome variables targeted by both CBT and~     mindfulness based treatment modalities. Although the efficacy of MBCT depression and for~     other populations has been investigated, there is no extant literature reporting on MBCT for~     chronic pain. The current application proposes to investigate the feasibility and efficacy~     of an MBCT protocoll adapted for chronic pain in a series of pilot groups with headache pain~     patients. We selected headache pain patients for this trial because headache pain is a~     common complaint in the general population, is the most frequently reported cause of pain in~     medical practice, and is one of the most disabling conditions for both genders combined. To~     examine the feasibility of the adapted protocol, the investigators will investigate a number~     of treatment related outcomes such as recruitment, completion, and drop out rates. Both~     primary and secondary outcome variables will be investigated to determine treatment~     efficacy.~      This study will provide a research base examining the feasibility and efficacy of MBCT for~     pain. Results from this study will lay the foundation for future randomized controlled~     trials comparing MBCT to attention control, and future comparative effectiveness studies of~     MBCT and CBT.~   "
140708|NCT01213043|"~     This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg~     of Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly~     infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).~   "
140709|NCT01213030|"~     Positron Emission Tomography (PET) with fluorine-18 fluoromisonidazole (FMISO) has been used~     for several years as a non invasive imaging technique to study tumor hypoxia. Several~     experimental and clinical studies have indicated that FMISO uptake of tissues is correlated~     with tissue oxygen tension and that FMSO PET allows non-invasive differentiation between~     hypoxic and normoxic tumors. Currently, FMISO-PET represents the best characterized and~     validated noninvasive hypoxia imaging technique. Nevertheless, clinical studies have also~     shown the limitations of FMISO PET. Accumulation of FMISO in hypoxic tumors is relatively~     low, resulting in a low contrast between hypoxic tumors and surrounding normal tissues. In~     addition, imaging needs to be started relatively late after tracer injection (about 3 hours~     post-injection), when a significant percentage of the fluorine-18 label has already decayed~     and the count statistics of the PET images are relatively low. Because of these limitations,~     FMISO PET is still only used at a few research centers, despite high clinical interest in~     hypoxia imaging.~   "
140710|NCT01213017|"~     The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the~     inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active~     moderate to severe rheumatoid arthritis.~   "
140711|NCT01213004|"~     Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing~     causes tumors to move. If the tumor moves during breathing, it can look blurred on the CT~     scan. This makes it difficult to see on CT scan. The investigators wish to investigate~     whether a new computer method makes tumors less blurry and easier to see on CT scan.~     Cone-beam CT is a type of CT scanner attached to the radiation treatment machine that~     produces 3D images of the patient. Since your tumor can move because of your normal~     breathing, it is often blurry and difficult to see accurately in a standard cone-beam CT~     scan. The investigators intend to use a computer method which processes the cone-beam CT~     data in a way that reduces the blurring and makes the tumor easier to see.~   "
140712|NCT01212991|"~     The purpose of this study is to determine the benefit of enzalutamide versus placebo as~     assessed by overall survival and progression-free survival in patients with progressive~     metastatic prostate cancer who have failed androgen deprivation therapy but not yet received~     chemotherapy.~   "
140713|NCT01212978|"~     The American Heart Association (AHA) and American College of Sports Medicine (ASCM)~     recommend older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity~     aerobic exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from~     data supporting that regular physical activity reduces the risk of adverse cardiovascular~     events A portion of these benefits may be from reductions in the incidence and severity of~     cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.~      While this recommendation for physical activity has been in existence for almost 15 years,~     the rates of obesity in the United States continue to rise and prevalence of sedentarism~     remains at best unchanged. Researchers have been engaged in investigating novel~     interventions to designed increase physical activity to reach the recommended activity~     targets. One promising intervention involves use of inexpensive, easy to use pedometers that~     allow individuals to objectively track the number of steps taken during a set period of~     time. Recent data suggest that an average of 10,000 steps/day as measured by a pedometer~     accurately estimates the activity levels recommended by the AHA, ASCM, and US government~     public health guidelines.~      While the benefits of habitual exercise are well-documented, there are no data that~     demonstrate current recommendations for moderate physical activity in older adults by the~     ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events.~     Interestingly, prior work indicates that pedometer-centered interventions can increase~     physical activity, suggesting that this type of intervention could potentially lead to~     cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including~     brachial artery endothelial function, tonometric measurements of vascular stiffness, and~     measurements derived from transthoracic echocardiography, we will determine whether~     increasing the physical activity of sedentary adults to an average of 10,000 steps or~     more/day translates into improvements in cardiovascular health. This will be determined in~     the context of a randomized control trial employing a control group, a study group that uses~     a pedometer alone, and an intervention that couples a pedometer with internet-based~     motivational messaging software demonstrated in our preliminary data to encourage older~     adults to reach and exceed the 10,000 steps/day goal.~   "
140714|NCT01212965|"~     The investigators propose a pilot trial to obtain preliminary information regarding the~     safety and response rate of patients with symptomatic lymphatic malformations treated with~     oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2~     clinical trials.~      Hypotheses:~        -  Selenium will be safe and efficacious in the treatment of adolescents and young adults~          with symptomatic lymphatic malformations~        -  Disease response will correlate with serum levels of selenium and blood levels of~          antioxidants essential to selenium metabolism.~   "
140717|NCT01212926|"~     It is now accepted that the anticancer properties of anthracyclines were allowed in many~     malignancies improve the prognosis of affected populations.~      However, the cardiotoxicity of anthracyclines is responsible for an interruption of this~     treatment by alteration of potentially irreversible myocardial contraction and high~     mortality.~      An earlier detection of adverse myocardial anthracycline chemotherapy would allow the~     adaptation of the regimen by reducing the number of interruptions of antitumor and~     strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in~     survival of patients treated.~   "
140719|NCT01212900|"~     Background:~      - Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits)~     commonly occurs in the heart vessels and carotid (neck) arteries of adults. This is often~     present in individuals with high cholesterol levels in their blood. These patients are~     usually treated with cholesterol lowering medication ( statins ) along with modification of~     diet and exercise. Researchers are interested in investigating new approaches including~     magnetic resonance imaging (MRI) and computed tomography (CT) imaging studies to detect~     blood vessel blockages that would not otherwise be detected by cholesterol levels and risk~     factors for heart disease.~      Objectives:~      - To measure atherosclerosis in the heart vessels and carotid arteries using imaging tests~     (computed tomography (CT) and magnetic resonance imaging (MRI)) before and after standard~     treatment with cholesterol lowering medication ( statins )~      Eligibility:~      - Healthy individuals at least 55 years of age who are candidates for therapy to lower their~     blood cholesterol levels.~      Design:~        -  This study will involve one screening visit and seven study visits over a period of 2~          years.~        -  Participants will be screened with a physical examination and medical history, as well~          as blood samples and tests to ensure that it is safe for them to have CT and MRI scans.~          Participants will provide information on current medications, dietary habits, smoking~          status, alcohol and caffeine intake, and their level of physical activity.~        -  Participants will be divided into two groups. One group will receive standard doses of~          medication to lower cholesterol according to current treatment guidelines, while the~          other group will have MRI scans of the carotid arteries and a CT scan of the heart to~          determine the best medication dose levels.~        -  Visits 3 to 5 will be scheduled 3, 6, and 9 months after visit 2. During these visits,~          researchers will monitor for possible side effects and may change or adjust medications~          and doses.~        -  At visit 6, participants will have an MRI scan of the carotid arteries, a physical~          examination, and blood tests. Medications may be changed or adjusted.~        -  At visit 7, participants will have blood tests, and medications may be changed or~          adjusted.~        -  At the final visit, participants will have MRI and CT scans of the carotid arteries and~          heart, respectively, as well as a final physical examination and blood tests.~   "
140720|NCT01212887|"~     RATIONALE: Placing a gene into T cells may improve the body's ability to recognize cancer~     cells and build an immune response to fight cancer. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Biological~     therapies, such as aldesleukin, may stimulate the immune system in different ways and stop~     cancer cells from growing. Giving specially treated T cells together with cyclophosphamide,~     fludarabine phosphate, and aldesleukin may kill more tumor cells.~      PURPOSE: This phase I clinical trial is studying the side effects and best dose of treated T~     cells when given together with cyclophosphamide, fludarabine phosphate, and aldesleukin in~     treating patients with cancer.~   "
140721|NCT01212874|"~     This is an investigator initiated, sponsored, open label, prospective randomized controlled~     trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will~     be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that~     occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary~     bypass (CPB).~   "
140722|NCT01212861|"~     The primary objective of this study is to evaluate the safety, efficacy, and performance of~     the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and~     the suprachoroidal space in refractory, open angle glaucoma subjects.~   "
140723|NCT01212848|"~     The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is~     effective in the treatment of suicidal thinking in individuals with a depressive episode and~     either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI),~     or both conditions.~   "
140724|NCT01212835|"~     Silastic rings have been used around the gastric pouch in order to promote better weight~     loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown~     that some patients developed gastroesophageal reflux disease after RYGBP in a previous~     study. The investigators hypothesized that the use of a silastic ring may play a role in~     promoting GERD after this operation.~   "
140725|NCT01212822|"~     This pilot phase II trial studies how well giving bevacizumab and combination chemotherapy~     together before surgery works in treating patients with locally advanced esophageal or~     stomach cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in~     different ways. Some block the ability of tumor cells to grow and spread. Others find tumor~     cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed. Giving these~     treatments after surgery may kill any tumor cells that remain after surgery.~   "
140726|NCT01212809|"~     This study is being done to evaluate the differences in the performance of two well known~     injectable dermal fillers commonly used for the cosmetic treatment of age lines above the~     lips and on the cheeks when compared to each other in the same patient. The products being~     tested are Juvéderm® Ultra and CosmoDerm® 1.~   "
140727|NCT01212796|"~     The allogeneic hematopoietic stem cell marrow is the only curative treatment for many~     hematologic malignancies. However, many patients relapse in these situations to be~     therapeutic possibilities scarce and mixed. Chemotherapy in these situations does not show~     good results and new drugs have not yet demonstrated the effectiveness desired.~      Another therapeutic approach after relapse post allogeneic transplant is to resubmit the~     allogeneic transplant patient to patient. In this clinical situation is little known. All~     previous studies are retrospective, the data provided are of little statistical value and~     heterogeneous patient samples.~      The GETH (Grupo Espanol de trasplantes hematopoyeticos y terapia celular) has included in~     its database a figure around 350 seconds allogeneic transplants. Comparing this with the~     studies published so far, this would be the largest retrospective series published size~     compared to second allogeneic transplants.~   "
140728|NCT01212783|"~     The purpose of this study is to determine the efficacy of In-Home Cognitive Behavioral~     Therapy (IH-CBT) in comparison to Present-Centered Therapy (PCT), a supportive therapeutic~     approach. IH-CBT is adapted form of CBT that is provided to depressed mothers participating~     in ongoing home visitation services. IH-CBT has been adapted to fit the setting, population,~     and context associated with home visiting. Mothers are recruited at 4 months postpartum. A~     comprehensive assessment battery is administered at pre-treatment, post-treatment, and 6,~     12, and 18 months after the end of treatment. It is hypothesized that IH-CBT will be~     superior to PCT in decreasing depression, improving overall functioning, enhancing parenting~     effectiveness, and preventing relapse.~   "
140729|NCT01212770|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
140807|NCT01211756|"~     The objective of the study is to compare the efficacy of intranasal oxytocin versus~     intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder~     (MDD) or Dysthymia Disorder.~   "
140730|NCT01212757|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis.~      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and~     swollen joints, pain, physical function) in treated patients.~   "
140731|NCT01212744|"~     The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on~     the reduction of blood Phe concentrations in subjects with PKU.~   "
140732|NCT01212731|"~     The purpose of this study is to:~        -  estimate the degree of memory loss, if any following radiotherapy to the base of skull~          or brain as measured by standard neurocognitive battery testing.~        -  describe radiotherapy dose-related changes in vascular perfusion, in spectroscopic~          parameters of neuronal injury and changes in the degree and directionality of tissue~          water diffusivity (diffusion tensor imaging) as a measure of white axonal injury.~        -  to relate these imaging characteristics to the degree of memory loss.~   "
140733|NCT01212718|"~     The aim of the study was to evaluate the feasibility of TS determination in a multicenter~     trial setting using a central facility for measurement and confirm its role as predictive~     factor for 5-FU treatment in MCRC.~   "
140734|NCT01212705|"~     Sleep disordered breathing is common in patients with chronic heart failure. Adaptive~     servoventilation is a novel method of treatment central sleep apnoea, especially associated~     with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive~     servoventilation on cardiac function, exercise tolerance and quality of life in patients~     with chronic heart failure.~   "
140735|NCT01212692|"~     The purpose of this study is to learn if activities that challenge the brain (mentally~     stimulating activities) can improve memory and other types of thinking in patients with Mild~     Cognitive Impairment. The study will compare the effects of different methods of mental~     stimulation.~   "
140736|NCT01212679|"~     Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected~     predominantly at a young age who in the most severe cases remain with permanent~     physical,psychological and cognitive deficits.This study will investigate the therapeutic~     effects of intranasal Nerve Growth Factor(NGF) in TBI.~   "
140737|NCT01212666|"~     The Purpose of this study is to determine whether Adductor-Canal-Block is superior to~     placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate~     ligament.~   "
140738|NCT01212653|"~     1. To determine the effect of Golimumab treatment on the number and function of~          Endothelial Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a~          possible mechanism for the effect of this treatment on endothelial function.~        2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness,~          vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave~          velocity (PWV) and Augmentation index (AIx).~        3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS)~          patients according to ASAS response criteria at month 3, 6 and 12.~        4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing~          Spondylitis(AS) patients, using clinic-base data.~   "
140739|NCT01212640|"~     OBJETIVES:~        1. To research the worsening of respiratory status risk factors after transfusion in~          spanish critical care units.~        2. To determine the incidence of transfusion-related acute lung injury (TRALI) in~          critically ill patients.~        3. To research the morbi-mortality of TRALI.~   "
140740|NCT01212627|"~     The main purpose of this study is to evaluate the best dose, safety and side effects of~     ridaforolimus when given with cetuximab for patients with head and neck, lung and colon~     cancer that has progressed after initial therapy. A second purpose of this study is to gain~     preliminary information on whether the combination of ridaforolimus and cetuximab is helpful~     in treating patients with advanced head and neck cancer~   "
140741|NCT01212614|"~     This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and~     SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric~     secretion on the volume as well as the acidity of gastric secretion by high dose proton pump~     inhibitors in GERD patients and healthy controls. Twelve participants in each group will be~     studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI~     technique developed in Zurich will assess the volume of gastric secretion following the~     ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring~     will assess the link between volume and intragastric distribution of gastric secretion on~     reflux events and symptoms. In addition, the effect of gastric secretion on outcome~     parameters of a non-invasive stable isotope breath test for measurement of gastric emptying~     will be assessed.~   "
140742|NCT01212601|"~     This is a Multicenter, observational, non-interventional registry designed to collect~     clinical data in Chinese patients who have received CUBICIN treatment under condition of~     actual usage in clinical practice.~   "
140743|NCT01212588|"~     Participants will be randomized to either Mifepristone 600mg once daily for seven days or~     Placebo tablet once daily for seven days. Rating scales, vital signs, cortisol levels will~     be collected for evaluation.~   "
140744|NCT01212575|"~     The primary objective of this non-interventional study is to investigate how Seroquel XR and~     Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will~     be done by a retrospective review of medical records to evaluate patients treated with~     Seroquel XR or Seroquel IR as primary antipsychotic treatment.~   "
140745|NCT01212562|"~     The purpose of this study is to evaluate the efficacy of cryosurgery during continuing~     imiquimod application in the treatment of basal cell carcinoma of the skin.~   "
140746|NCT01212549|"~     To compare the effectiveness of two application schemes of cryosurgery during a 5 week~     course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod~     followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0~     followed by 5 weeks of topical imiquimod (cryoimmunotherapy)~   "
140747|NCT01212536|"~     The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope~     with conventional direct laryngoscopy for tracheal intubation in a randomised crossover~     study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good~     as conventional laryngoscopy for tracheal intubation of infants and children. This will be~     an equivalence rather than a non-inferiority study.~   "
140749|NCT01212510|"~     The primary purpose of the study is to confirm the results of previous study about the~     usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring~     in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6).~     The secondary purpose is to evaluate the value of circulating free mutant DNA and~     circulating tumor cells (CTC) and their variations during the treatment.~   "
140750|NCT01212497|"~     Evaluate the effectiveness of using a virtual computer coach to provide mindfulness~     meditation training, and the coaching support required to initiate a regular practice.~   "
140751|NCT01212484|"~     This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and~     vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or~     hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive~     disease in which the growth and development of selective nerves is impaired. Patients with~     FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing,~     tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have~     intolerable side sides. Our long-term goal is to treat nausea effectively and without side~     effects, a therapeutic intervention that would markedly improve the quality of life of~     patients with FD.~      The investigators have recently found that resting plasma dopamine levels are high in~     patients with FD and increase up to 40-fold during nausea and vomiting attacks. This led us~     to postulate that stimulation of dopamine receptors in the chemoreceptor trigger zone of the~     brainstem is the likely mechanism of vomiting.~      Carbidopa is a reversible competitive inhibitor of aromatic L-amino acid decarboxylase (also~     known as dopa-decarboxylase) that cannot cross the blood brain barrier. It has been used~     successfully for many years to block the extracerebral synthesis of dopamine and avoid~     nausea and vomiting in patients with Parkinson's disease taking levodopa. The investigators~     reasoned that carbidopa could have a similar antiemetic effect in patients with FD.~      The investigators propose to conduct a pilot trial to assess the safety, tolerability and~     efficacy of carbidopa for the treatment of nausea in patients with FD. The pilot trial will~     recruit 25 patients with FD who complain of severe nausea that affects their quality of~     life. The trial will be divided into two consecutive, but independent parts. Part 1, will~     address the safety and tolerability of carbidopa in patients with FD using an open-label~     dose titration phase followed by 4-weeks of open-label treatment. Part 2, will address the~     efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized,~     placebo controlled, double blind, 4-week cross over design.~      The investigators hope to demonstrate that carbidopa is a safe, well-tolerated drug that~     blocks the peripheral formation of dopamine and thus prevents dopamine-induced nausea and~     vomiting attacks in patients with FD.~   "
140752|NCT01212471|"~     A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry~     eye disease.~   "
140753|NCT01212458|"~     Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine~     Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung~     moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie~     schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder~     diabetischer Polyneuropathie).~      In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich~     ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal®~     (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt.~     Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der~     Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen~     Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon®~     die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der~     Haut vermindert werden.~        -  Trial with medicinal product~   "
140754|NCT01212445|"~     The primary objective of the study was to evaluate the proportion of subjects with a bowel~     movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of~     treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus~     Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses~     of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported~     BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM~     control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.~      In addition, the proportion of subjects with a BM (without straining and without hard and/or~     lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E~     was evaluated for the time to first BM.~   "
140755|NCT01212432|"~     Daptomycin kinetics in CRRT~        -  Trial with medicinal product~   "
140756|NCT01212419|"~     Objectives: Sleep characteristics have been used for prediction of neuro-developmental~     outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the~     development of SWC in newborns > 32 weeks' gestational age after major non-cardiac surgery.~      Study design: This prospective aEEG study included infants > 32+0 weeks' gestation admitted~     to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were~     undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ~     Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC~     and the maximum levels of morphine and midazolam as predictors of time to SWC were then~     assessed.~      Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean~     of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of~     time to SWC.~      Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was~     observed on aEEG in neonates > 32 weeks' gestational age soon after major non-cardiac~     surgery. The main type of aEEG background pattern was not affected by the maximum dose of~     either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always~     drug related.~   "
140757|NCT01212406|"~     Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment~     with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after~     lung transplantation~   "
140758|NCT01212393|"~     The appropriate use of thromboprophylaxis in medical patients admitted to hospital can~     substantially reduce the overall burden of disease due to venous thromboembolism. However,~     the use of thromboprophylaxis in medical setting appears to be generally poor leaving~     at-risk patients unprotected.~      We aim to analyse the incidence of symptomatic thromboembolic disease following~     hospitalisation in medical setting and the efficacy of a multicomponent prevention approach~     in emergency department including systematic evaluation of thrombosis risk factors and~     remembers of thrombophylaxis indications and modalities for acutely ill medical patients.~      Design: cluster randomized interventional study - Observational study at patient level~      Setting: 30 French emergency departments~      Patients: Patients over 40 years old admitted in participating emergency departments and~     hospitalized for acute medical reasons.~      Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage~     during a formal 3-months follow-up after hospital admission in patients hospitalized at~     least 48 hours.~   "
140759|NCT01212380|"~     RATIONALE:~      Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~      PURPOSE:~      This phase I trial is studying the side effects and the best dose of carfilzomib in treating~     patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic~     lymphoma(SLL), or prolymphocytic leukemia (PLL).~   "
140760|NCT01212367|"~     This research will study how to activate the immune system by using gene transfer. Gene~     transfer involves inserting a specially designed gene into cancer cells. A gene is a part of~     the genetic code that instructs the cells of our bodies to produce specific compounds~     (proteins) important for the makeup or function of the cell. The study hypothesis is that~     repeated doses of SCH 721015 given over a three day interval would result in gene transfer.~   "
140761|NCT01212354|"~     The major clinical problem and predominant cause of death after radio-oncological treatment~     of H+N cancers are loco-regional relapses. This randomized trial tests the hypothesis that~     dose escalated Intensity Modulated Radiotherapy (IMRT) selectively applied to the~     macroscopic primary tumor and involved neck nodes - which both in 80% - are hypoxic improves~     loco-regional control by at least 15% at 2 years. IMRT is combined with concurrent~     Cis-Platin chemotherapy. Tumor volume which correlates with number of malignant cells as~     well as tumor hypoxia are important biological parameters which increase radio-resistance,~     failure of local control and tumor progression. Basing on data of experimental and clinical~     radiation oncology we consider hypoxia as a useful parameter for pre-therapeutic~     strati-fication in future randomized radio-chemotherapy trials.~      In addition, hypoxia imaging by PET can be used for testing the significance of selective~     dose escalation on hypoxic tumor sub-volumes (Dose Painting).~      As a prerequisite for such innovative studies addressing hypoxia the translational part~     investigates the following key issues: correlation between the size of total tumor volume~     (primary, lymph nodes) and hypoxic sub-volume, the spatial shift of the hypoxic sub-volume~     before start of treatment and the correlation of loco-regional control and hypoxia.~      Before starting the main study a pre-study to assess the occurrence of radiation induced~     toxicities is mandatory to be performed. In a step-wise dose-escalation in a cohort-design~     the safety of dose-escalation should be determined. Step one: 6 patients Step two: 14~     patients. In the pre-study the 1st group (6 patients) should be treated with 2.2 Gy up to~     77.0 Gy for DEVPT and DEVLK. After evaluation of the toxicity the next 14 patients should be~     treated by this scheme.~   "
140762|NCT01212341|"~     Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor~     who underwent leukapheresis. These cells were processed based on a novel method for ex vivo~     activation and expansion using an irradiated and activated autologous feeder cell system.~     MG4101 has anti-tumor activities against various tumors including malignant lymphomas in~     vitro as well as in vivo tumor model.~   "
140763|NCT01212328|"~     Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally~     and Asian Indians will account for between 40-60% of the global CVD burden within the next~     10-15 years. Risk factor control and preventive care are effective in reducing CVD events~     and mortality. The greatest gains in CVD prevention have been seen when early and~     target-driven interventions address multiple risk factors together. However, achieving~     control of even individual risk factors (blood glucose, blood pressure, or blood lipid~     targets) is poor, globally. Quality improvement schemes, like the proposed intervention,~     have shown promise in high-income countries, but are untested in South Asia; a region with a~     population at extraordinarily high CVD risk.~      Objective: To test whether a clinic-based case management intervention (consisting of~     guidelines based treatment, care coordinator assistance and decision support software) to~     reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is~     more effective and sustainable compared to existing care.~      Trial subjects and methods: The study will involve a total of 1120 patients attending 8~     established out-patient clinics in South Asia (140 patients at each clinic). Patients~     enrolled in the trial will be randomly assigned to either the control (existing care) or the~     intervention group and will be followed up for an average of 30 months. The total trial~     duration is about 3.5 years, from mid-August 2010 to December 31, 2013.~   "
140764|NCT01212315|"~     The purpose of this study is to assess if triclosan-coated sutures reduces wound infections~     after saphenous vein harvesting in CABG patients. Secondary objectives are the effect~     triclosan-coated sutures on sternal wound infections and a cost analysis.~   "
140765|NCT01212302|"~     Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of~     great importance for treatment following coronary stenting. Unfortunately the variable~     platelet inhibitory effectiveness compromises the antithrombotic benefit of dual~     antiplatelet therapy. The aim of this prospective single centre study was to reduce the low~     response incidence of dual antiplatelet therapy with ASA and clopidogrel based on a~     standardized therapy algorithm.~   "
140766|NCT01212289|"~     Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass~     (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood~     loss during and after operation. While of significant concern in adults, this problem takes~     on even greater importance in children due to the simple fact that they have a smaller blood~     volume. It is well known that if a child has previously undergone a heart operation, they~     are at increased risk of bleeding should more cardiac surgery be required (reoperation).~     The processes regulating blood coagulation are extraordinarily complex, and little is known~     about the exact mechanisms that contribute to the increased bleeding associated with cardiac~     reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can~     provide, at the bedside, detailed information about coagulation abnormalities. While not~     currently approved for general use in the United States, in Europe ROTEM® has been used to~     guide administration of the blood products in surgery based upon determination of specific~     coagulation abnormalities. Importantly, there is now evidence that guidelines for~     transfusion therapy based on ROTEM® reduce transfusion requirements thus decreasing patient~     exposure to blood products. Whether the use of ROTEM® has potential benefit for pediatric~     cardiac surgical patients has not been studied. Accordingly, the present study was designed~     to provide preliminary data comparing coagulation profiles between children undergoing~     cardiac reoperation to those having primary procedure.~      The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired~     coagulation in children undergoing reoperation. The overall objective of the four assays of~     ROTEM® analysis therefore, is to provide information that can be used to devise a rational~     transfusion protocol for pediatric cardiac surgical subjects.~   "
140767|NCT01212276|"~     The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective,~     and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.~   "
140808|NCT01211743|"~     Study of Oxidative Stress Markers in order to assess whether there are differences between~     standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated~     cholelithiasis~   "
140768|NCT01212263|"~     To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene~     citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation~     rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better~     pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary~     FSH in these cases.~   "
140769|NCT01212250|"~     Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled.~     After baseline evaluation, the participants will be randomized to receive either Placebo or~     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.~   "
140770|NCT01212237|"~     Normal tissue response is critical for brain radiotherapy, especially for dose escalation~     which carries with it an increased incidence of radiation-induced brain injury. Although~     radiation toxicity and limiting dose for anatomically critical structures of the brain have~     been well studied and documented, little is known for functionally critical brain regions~     and treatment of cognitive sequelae of cranial radiotherapy is limited. The objective of~     this clinical protocol is to accumulate preliminary data for future studies aiming to~     quantify dose response for functionally critical brain regions for brain radiotherapy. We~     plan to achieve this objective by correlating the radiation-induced complications and~     radiological changes with the radiation dose to the selected functionally critical brain~     regions for 25 patients. Each participating patient will receive brain fMRI to identify~     brain regions for processing visual, working memory and language functions. The image~     co-registration algorithm developed previously by our group will be used to co-register~     these regions on the CT scans for radiotherapy treatment planning for radiation dose~     calculation. Radiation-induced changes in cognitive functions will be evaluated using the~     modified mini mental status exam (3MS) and fMRI during the routine follow-up. The knowledge~     derived from this study might significantly improve the quality of life and allow safer dose~     escalation for patients receiving brain radiotherapy.~   "
140771|NCT01212224|"~     This is a confirmation of safety profile for Minirin Melt in clinical practice.~   "
140772|NCT01212211|"~     Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently,~     association between hyponatremia and bone fractures in the ambulatory elderly has been~     shown.~      Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention~     deficit.~      Symptoms related to hyponatremia can be very subtle and difficult to detect clinically.~     Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be~     included. They will be randomised. The physician will review the drug treatment of ten~     patients in coordination with the opinion of pharmacologists. Drug treatment for ten other~     patients wil remained unchanged during the three months of inclusion.~      Useful elements of the medical records of patients randomized to the experimental arm will~     be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The~     notice, subject to the attention of physician of retirement homes, give rise to a~     therapeutic approach towards the patient. It will be followed by weekly monitoring of serum~     sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of~     medical intervention will be evaluated by an objective biological criteria: serum sodium in~     the fourth week. Secondary endpoints will evaluate the duration of normalization of serum~     sodium and check the interest of correcting hyponatremia to improve postural capacities and~     eventually reduce the number of falls in the medium term (three months).~   "
140773|NCT01212198|"~     This is an observational study done by creating a cohort of Korean patients with diabetes~     and those at high risk of developing diabetes. By the creation of this cohort we aim to~     establish efficient preventive, diagnostic, and therapeutic measures based on the~     characteristics of Korean patients with diabetes, and by doing so, we hope to ultimately~     decrease our country's diabetes-related-mortality and increase the quality of life of~     patients with type 2 diabetes.~   "
140774|NCT01212185|"~     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective~     in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring~     standard medication treatment (lorazepam) and the amount of lorazepam required to control~     withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of~     subject recruitment and retention in the inpatient setting.~      Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical~     detoxification.~      Procedures (methods): Subjects will be inpatients undergoing medical detoxification from~     alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a~     randomized, double blind manner for three days. Withdrawal symptoms will be measured~     routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever~     withdrawal symptoms increase above specific parameters.~   "
140775|NCT01212172|"~     The purpose of this research study is to compare two different 810 diode laser systems~     (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine~     if each laser system is effective at reducing the amount of hair on the lower legs or the~     axilla (arm pit). Another goal is determine the subject's perspective on the treatment~     including tolerability and effectiveness.~   "
140776|NCT01212159|"~     The purpose of the study is to demonstrate that systematic self measurement of blood lipids~     reduces LDL cholesterol more effectively than standard care. The hypothesis is that~     cholesterol lowering medication adherence will be improved with self monitoring and~     reporting of frequent blood lipids and the percentage of patients achieving LDL goal will be~     greater than without home monitoring.~   "
140777|NCT01212146|"~     The aim of the present randomized double-blind controlled crossover study is to compare the~     effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus~     paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory~     relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients~     suffering from functional constipation.~   "
140778|NCT01212133|"~     This study is conducted in Asia. The aim of this study is to evaluate the safety and~     effectiveness of liraglutide in subjects with type 2 diabetes mellitus.~   "
140809|NCT01211730|"~     Many but not all studies have shown improvement in morbidity and mortality with intensive~     glycemic management postoperatively. In this study, the investigators propose to determine~     whether improved glycemic control using intensive insulin treatment immediately~     postoperatively will improve outcomes in patients undergoing liver transplant using a~     prospective, controlled, randomized, parallel-group study design targeting two different~     glucose levels, 140 and 180 mg/dL.~   "
140779|NCT01212120|"~     The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for~     diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus~     strains found in the noses and on the foot lesions of diabetic patients. The investigators~     are also studying the virulence of these strains, the prevalance of S aureus at either site,~     and whether or not the quantity of S aureus found in the nose affects the risk for infection~     in foot lesions. The investigators also use this study to test the sensitivity and~     specificity of the GeneXpert system.~   "
140780|NCT01212107|"~     The study is to determine the recommended Phase 2 regimen of study drug that may be safely~     administered to patients with advanced and or metastatic cancer. The study consists of two~     parts: a dose escalation and a dose confirmation.~   "
140781|NCT01212094|"~     Background:~      - Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple~     sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop~     SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in~     determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some~     types of cancer, is able to target certain white blood cells that are thought to play a role~     in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal~     cord, participants will receive it by intravenous drip and by intrathecal injection (through~     a lumbar puncture into the cerebrospinal fluid).~      Objectives:~      - To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab~     in individuals with secondary-progressive multiple sclerosis.~      Eligibility:~      - Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have~     been off any form of immunosuppressive therapy for at least 3 months.~      Design:~      - The study will involve a 1-year pretreatment baseline series of visits, followed by a~     2-year treatment period. Participants will provide blood samples throughout treatment as~     directed by the study researchers, and additional studies may be performed during the study~     period if participants consent to further investigation.~   "
140782|NCT01212081|"~     Background:~      - Individuals with schizophrenia or schizoaffective disorders have a high prevalence of~     cannabis use. Understanding some of the environmental factors that maintain cannabis use,~     such as socially triggered cravings, is a critical step in improving treatment for cannabis~     dependence. In recent years, virtual reality has been studied to determine whether it can be~     used to induce craving by using life-like cue settings. Researchers are interested in using~     virtual reality systems to study cannabis cravings in individuals with schizophrenia.~      Objectives:~      - To determine if virtual reality cues will elicit cannabis craving in persons with~     schizophrenia who have a history of cannabis use.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia or~     schizoaffective disorders, are on a stable antipsychotic medication, and who have a lifetime~     history of at least 50 cannabis uses and average cannabis use of once per month.~      Design:~        -  This study involves an initial screening visit, a study visit, and a followup visit.~        -  Participants will be screened with a medical history and physical examination, and will~          complete questionnaires about their history of marijuana and other drug use.~          Participants will also learn how to use the virtual reality equipment at this visit.~        -  During the study visit, participants will respond to marijuana cues using the virtual~          reality system while researchers monitor their heart rate, blood pressure, and sweat~          levels.~        -  At the followup visit, participants will complete questionnaires about their mood and~          any cravings for marijuana.~   "
140783|NCT01212068|"~     Background:~        -  People with epilepsy often have auditory processing disorders that affect their ability~          to hear clearly and may cause problems with understanding speech and other kinds of~          verbal communication. Researchers are interested in developing better ways of studying~          what parts of the brain are affected by hearing disorders and epilepsy, and they need~          better clinical tests to measure how individuals process sound. These tests will allow~          researchers to examine and evaluate the effects of epilepsy and related disorders on~          speech and communication.~        -  A procedure called a magnetoencephalography (MEG) can be used to measure the electrical~          currents involved in brain activity. Researchers are interested in learning whether MEG~          can be used to detect differences in the processing of simple sounds in patients with~          epilepsy, both with and without hearing impairments.~      Objectives:~      - To measure brain activity in hearing impaired persons with epilepsy and compare the~     results with those from people with normal hearing and epilepsy as well as people with~     normal hearing and no epilepsy. This research is performed in collaboration with Johns~     Hopkins Hospital and epilepsy patients must be candidates for surgery at Johns Hopkins.~      Eligibility:~        -  Individuals between 18 to 55 years of age who (1) have epilepsy and have hearing~          impairments, (2) have epilepsy but do not have hearing impairments, or (3) are healthy~          volunteers who have neither epilepsy nor hearing impairments.~        -  Participants with epilepsy must have developed seizures after 10 years of age, and must~          be candidates for grid implantation surgery at Johns Hopkins Hospital..~      Design:~        -  This study will require one visit of approximately 4 to 6 hours.~        -  Participants will be screened with a full physical examination and medical history,~          along with a basic hearing test.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the brain, followed~          by a MEG scan to record magnetic field changes produced by brain activity.~        -  During MEG recording, participants will be asked to listen to various sounds and make~          simple responses (pressing a button, moving your hand or speaking) in response to~          sounds heard through earphones. The MEG procedure should take between 1 and 2 hours.~        -  Treatment at NIH is not provided as part of this protocol.~   "
140784|NCT01212055|"~     Background:~      - Gene therapy is being investigated as a possible treatment for individuals with~     immunodeficiency diseases or other conditions that make it difficult to fight off infection.~     Gene therapy avoids problems with donor identification and possible rejection of bone marrow~     transplant by using the patient s own modified blood cells to help treat the disease.~     Researchers are interested in collecting stem cells from the blood of individuals with~     immunodeficiency diseases in order to use the cells to develop potential gene therapy~     treatments.~      Objectives:~      - To collect blood stem cells from patients with immunodeficiency diseases tto test our~     ability to correct the defects of these cells in the test tube. .~      Eligibility:~        -  Individuals between 18 and 40 years of age with immunodeficiency diseases.~        -  Individuals with human immunodeficiency virus (HIV) will not be able to participate in~          this study.~      Design:~        -  Participants will provide an initial blood sample for disease screening (such as~          hepatitis B and C, syphilis, or viruses like the Epstein-Barr virus, herpes simplex~          virus, or toxoplasmosis) and to check kidney and liver function.~        -  Starting 5 days before blood donation, participants will receive daily injections of a~          drug called G-CSF (granulocyte colony stimulating factor, or filgrastim), which pushes~          stem cells out of the bone marrow and into the bloodstream. Participants will receive~          the injections at the National Institutes of Health Clinical Center.~        -  On day 5, participants will have a single leukapheresis procedure to collect the stem~          cells from the blood.~        -  No additional treatment will be provided as part of this protocol. The cells that are~          collected will be used fore experiments in the lab and will not be used to treat~          individuals with these diseases.~   "
140810|NCT01211717|"~     The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino~     Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of~     muscle pain which usually develops after exercising.~   "
140812|NCT01211691|"~     This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose~     Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004~     will be administered by IV infusion once weekly as part of a 21-day dosing cycle.~   "
140785|NCT01212042|"~     Respiratory infections have a high associated morbidity and mortality, especially in~     immunocompromised patients. To initiate effective treatment of respiratory infections, it is~     essential that a rapid and thorough laboratory analysis of respiratory specimens be~     performed, given the wide range of pulmonary pathogens that can be detected in this~     population. Conventional microbiology is time-consuming and cumbersome, and the capability~     of local laboratories to assess specimens for rare or unusual pathogens is often limited.~     This study will evaluate if a newer technology can be effectively utilized in the~     identification of a broader range of infectious agents relative to conventional procedures.~      Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased~     operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical~     specimen. The technology has had limited clinical application, but early studies have shown~     its effectiveness in accurately identifying a large number of viral and bacterial organisms.~     In contrast to conventional microbiological procedures based on phenotypic traits (growth~     characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to~     detect and identify the species, serotype/subtype, or strain of the infectious agent.~      Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage,~     BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be~     analyzed using the customized microarray chip. The specimens will be collected as part of~     the patients routine clinical care. The results of the TessArray microarray analysis will~     not be available to the clinician and therefore will not have any effect on the clinical~     care of the patients.~      The results of the microarray analysis from each site will be compared to that site s~     clinical laboratory results, and the data will be analyzed by site.~   "
140786|NCT01212029|"~     Background:~      - Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to~     detect changes in blood volume and oxygen levels during brain activity. fNIR is being~     studied as a possible way to examine the brain activity of individuals who are unable to~     undergo standard brain function imaging techniques (such as functional magnetic resonance~     imaging, or fMRI). For instance, war veterans who have iron shrapnel in the body are not~     able to have fMRI scans, and very young children or children with autism and related~     disorders are often not able or willing to cooperate long enough in the MRI environment to~     allow full imaging studies to take place. Researchers are interested in comparing the~     results of fNIR and fMRI performed on healthy volunteers to determine if fNIR produces~     similarly accurate results.~      Objectives:~      - To examine the capabilities of non-invasive functional near infrared imaging techniques on~     healthy volunteers and compare the results with the existing outcomes of functional magnetic~     resonance imaging.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have one study visit. Depending on the complexity of the task, the~          whole exam will take between 5 minutes and 1 hour to perform.~        -  Participants will be asked to sit as still as possible while wearing a headband that~          includes light sources and detectors (the fNIR device).~        -  Participants will be asked to perform a set of tasks (e.g., reading sentences or~          counting numbers in one s head). Data will be collected during these experiments.~   "
140787|NCT01212016|"~     Background:~      - Food allergies are characterized by abnormal immune system responses to certain foods,~     such as peanuts, strawberries, and shellfish. Some individuals with these allergies have~     immediate allergic reactions on contact with the food in question and need immediate~     treatment to prevent severe complications. In contrast, eosinophil-associated~     gastrointestinal disorders are related disorders in which white blood cells in the~     intestinal tract react to certain foods, causing abdominal pain, nausea, and other digestion~     problems. Researchers are interested in studying these conditions to better understand how~     the immune system responds to food allergies.~      Objectives:~        -  To examine how the immune system responds to food allergens.~        -  To examine how certain white blood cells contribute to disease in individuals with food~          allergies and other inflammatory diseases.~      Eligibility:~        -  Individuals between 18 and 65 years of age who have a history of (a) severe allergic~          reaction to peanuts (and have peanut-specific antibodies), (b) allergy or inflammatory~          disease, or (c) eosinophil-associated gastrointestinal disorder (with at least two~          documented food allergies).~        -  Healthy volunteers between 18 and 65 years of age who have no known allergies or~          asthma.~      Design:~        -  All participants will have a screening visit and a procedure visit. The procedure visit~          will take place within 30 to 60 days of the screening visit, and will take 3 to 4 hours~          depending on the procedure(s) done.~        -  Participants will be screened with a physical examination and medical history, and will~          provide blood samples for testing. Participants with peanut or other allergies will~          have additional tests to determine their levels of sensitivity to certain foods.~          Participants with eosinophil-associated gastrointestinal disorder will provide stool~          samples for testing.~        -  At the procedure visit, participants with peanut allergies and participants with other~          allergies will provide blood samples and have leukapherisis to collect white blood~          cells for examination.~        -  At the procedure visit, healthy volunteers and participants with eosinophil-associated~          gastrointestinal disorder will provide blood samples and have leukapherisis to collect~          white blood cells for examination. In addition, some but not all of these participants~          will have a procedure called esophagogastroduodenoscopy (EGD), which will examine the~          esophagus, stomach, and small intestine. Participants who are scheduled to have EGD~          will be asked to fast for 6 hours before the procedure.~   "
140788|NCT01212003|"~     Background:~      - Tuberculosis (TB) is an infectious disease that affects numerous people worldwide.~     However, most clinical studies of individuals with TB take place at international sites~     because there are many fewer cases of TB in the United States than elsewhere in the world.~     To provide better training for infectious disease staff members at the National Institutes~     of Health Clinical Center in Washington, D.C., researchers are interested in actively~     recruiting individuals with TB for research and treatment studies.~      Objectives:~        -  To provide staff at the National Institutes of Health Clinical Center with increased~          experience in hands-on treatment of individuals with tuberculosis, including~          drug-sensitive or drug-resistant forms of the disease.~        -  To collect blood and other samples to study the natural history of tuberculosis.~      Eligibility:~      - Individuals 2 years of age and older who have either active or latent tuberculosis.~      Design:~        -  Latent TB patients: Participants will have a single study visit with a physical~          examination and medical history, and will provide blood samples for testing.~        -  Active TB patients: Participants will have an initial visit with a physical examination~          and medical history, and will provide blood samples for testing. Participants will also~          provide sputum samples if required, and may have an optional skin punch biopsy to~          collect a sample of skin tissue for study.~        -  Treatment for active TB will be provided as part of this protocol.~        -  Active TB participants will return for study visits every 2 months while receiving~          treatment, and will return every 6 months for 1 year after the end of treatment.~          Participants may be asked to return more often if researchers determine that additional~          care is needed to treat the infection.~   "
140789|NCT01211990|"~     Background:~      - State-of-the art care for children with cancer or rare diseases is not available in all~     countries. Owing to the proximity of Latin America and the growing numbers of Latinos~     already in the United States, many international patients receiving specialized medical care~     in U.S. hospitals are from Spanish-speaking countries. Although there are benefits~     associated with obtaining specialized care in the United States, linguistic barriers and~     cultural differences as well as the general stresses of caring for a child with a serious~     illness may affect families ability to obtain adequate care for their children. Researchers~     are interested in exploring the experiences and needs of international Latino families~     receiving medical care for their child in the United States in order to help health care~     centers provide more appropriate resources and improve the overall quality of culturally~     sensitive care.~      Objectives:~      - To understand the experiences of international Latino families who are receiving treatment~     for their child or have enrolled their child in a research study in the United States.~      Eligibility:~        -  Caregivers of a child between birth and 25 years of ages who are from Latin America~          (which includes Mexico, all countries in Central America and South America, and~          Spanish-speaking Caribbean countries) and who have traveled to the United States to~          enroll their child in a research protocol and/or seek treatment for their child s~          medical condition.~        -  Caregivers must have a child enrolled on a research protocol at the time of this study.~        -  Caregivers must have been away from their country of origin for a minimum of 3 months.~      Design:~        -  This study requires a single interview that should take approximately 1 hour.~        -  Participants will complete the interview with a member of the research team who is~          bilingual or fluent in Spanish.~        -  Participants will be asked open-ended questions about why they chose to come to the~          United States, how they are adjusting to living and getting medical care for their~          child in the United States, and what hopes they have for treatment outcomes and future~          medical care.~        -  Researchers will record the interviews to be reviewed later. The recordings will be~          used for this study only.~   "
140811|NCT01211704|"~     The primary specific aim is to examine the efficacy of Paliperidone extended release~     Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic~     symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The~     investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™)~     treated group will have a statistically significant advantage on improvement in manic~     symptoms. They will also have higher rate of treatment response and remission.~   "
140790|NCT01211977|"~     Background:~        -  Autoinflammatory diseases are illnesses that produce episodes of inflammation such as~          fever, rash, or joint swelling. Some of these diseases can be treated with medications~          that block the body's reaction to a protein called IL-1, which may be part of the cause~          of the inflammation. IL-1 blocking agents are very helpful in treating autoinflammatory~          diseases and have become the standard of care for treatment for some of these diseases.~          However, more research is needed on related diseases that may be treated with new and~          currently used IL-1 blocking agents.~        -  XOMA 052 is an experimental drug that is currently being tested as a possible treatment~          for type 2 diabetes. Initial studies have shown that XOMA 052 neutralizes a specific~          kind of IL-1, and is also active against certain indicators of inflammation.~          Researchers are interested in determining whether XOMA 052 can be used to treat~          autoinflammatory and related diseases.~      Objectives:~      - To determine the effectiveness of XOMA 052 as a treatment for inflammation in adults with~     the autoinflammatory diseases Familial Cold Autoinflammatory Syndrome (FCAS)/Muckle-Wells~     Syndrome (MWS) and Behcet's Disease.~      Eligibility:~        -  FCAS/ MWS: Individuals at least 18 years of age who have a known history of the typical~          disease.~        -  Behcet's Disease: Individuals at least 18 years of age who have evidence of active~          disease, such as oral or genital ulcers or eye disease.~      Design:~      FCAS/MWS Participants~        -  Participants will have an overnight evaluation of their disease, including optional~          tests (e.g., eye or skin exams). Participants who currently take medications to treat~          their symptoms will stop taking the medication and will be monitored by study~          researchers. At the first flare of symptoms, participants will begin to receive XOMA~          052.~        -  Participants will have further tests on days 3, 7, and 10 after the initial dose of~          XOMA 052. If the disease remains under good control, participants will have a clinical~          exam every 5 days for up to 10 weeks until another disease flare occurs (determined~          either by symptoms or by inflammation observed in laboratory studies). If the disease~          is not well controlled with the initial dose of XOMA 052, participants will have~          additional doses starting at day 7 until either the disease is controlled or~          researchers determine that the medication is not effective.~        -  Participants will have the option to continue XOMA 052 treatments for up to 1 year.~          XOMA 052 wil...~   "
140791|NCT01211964|"~     The purpose of this phase 1 study is to determine the relative bioavailability and~     pharmacokinetics following single oral dose administration of LEO 22811 solution compared to~     LEO 22811 tablet in healthy male subjects as well as to determine the effect of food on the~     single oral dose pharmacokinetics of LEO 22811 tablet in healthy male subjects.~   "
140792|NCT01211951|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
140793|NCT01211938|"~     Patients will be randomised after surgery, provided surgery is macroscopically adequate,~     that there is a flap of tissue protecting the vascular axis and that wound healing allows~     reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two~     arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume :~     tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume~     should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy~     will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in~     the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of~     reirradiation and at 6 months from randomization (first follow-up consultation)~   "
140794|NCT01211925|"~     Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible~     peripheral arterial occlusive disease.~   "
140795|NCT01211912|"~     This study has two aims:~        1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally~          given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)~        2. to understand the impact of maternal acetaminophen use on fetal movement and breathing~          (20 patients)~   "
140796|NCT01211899|"~     Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in~     Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate~     the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar~     coagulatin in patients with severe sepsis and septic shock.~   "
140797|NCT01211886|"~     Admission BNP was a useful marker for diagnosing and predicting type IV cardio-renal~     syndrome type IV in patients with chronic kidney disease admitted to the ICU for acute heart~     failure in a retrospective study. Therefore, we aim to prospectively investigate the utility~     of serum BNP in evaluating the treatment adequacy and predicting future cardiac events in~     patients with type IV CRS.~   "
140798|NCT01211873|"~     The purpose of this study is to look at the safety (what are the side effects)and efficacy~     (how well does it work) of Dotarem® when used in taking images of the brain / spine. The~     results will be compared to the results of MRI taken without Dotarem.~   "
140799|NCT01211860|"~     Once a day oral administration with DCCR is the optimal dosing regimen~   "
140800|NCT01211847|"~     Once a day oral administration with DCCR helps lower triglycerides~   "
140801|NCT01211834|"~     The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in~     combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in~     patients with moderate to severe active RA and inadequate response to current DMARD~     treatment~   "
140802|NCT01211821|"~     The purpose of the study is to assess the effects of BMS-914392 administration on the~     pharmacokinetics of a single-dose of metoprolol in healthy subjects.~   "
140803|NCT01211808|"~     The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of~     single-dose BMS-914392 in healthy subjects.~   "
140804|NCT01211795|"~     Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been~     shown to prevent migraines when used once daily for 3 months in open label studies. This is~     a randomized, double-blind, placebo controlled phase III prevention trial to determine~     safety and efficacy.~   "
140805|NCT01211782|"~     The study will evaluate the safety & efficacy of AC-1204, a ketogenic compound, administered~     orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study,~     subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be~     evaluated by standard tests of memory and cognition, along with other measurements of~     activities of daily living and quality of life. Safety will be assessed by frequency of~     adverse events and changes in laboratory test results. Subjects will be stratified and~     outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).~   "
140806|NCT01211769|"~     Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some~     studies have shown that alcohol alters the environment of the membranes, mainly by modifying~     their permeability through the lipid fraction. These lipids are known as essential fatty~     acids (EFA) because they are obtained only through the diet, as the human body is unable to~     synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega~     3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and~     metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence~     recovery.~      Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol~     dependent patients.~   "
140813|NCT01211678|"~     The primary objective of this study was to validate the ability of an 8-gene biomarker set~     to differentiate between participants who met or did not meet European League Against~     Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment~     with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200~     anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the~     behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who~     began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a~     biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional~     experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to~     anti-TNF therapy.~   "
140814|NCT01211665|"~     The objectives of this study are to explore the effects of administering high-dose~     corticosteroids to participants who developed progressive multifocal leukoencephalopathy~     (PML) while on natalizumab as measured by time-course change in functional status based on~     Karnofsky Performance Status Index through 6 months following the completion of plasma~     exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or~     equivalent), and incidence and severity of adverse events (AEs) and serious adverse events~     (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS)~     as measured by time course changes in Global Clinical Impression of Improvement (GCI-I),~     Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI),~     magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John~     Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize~     the time course elimination of serum natalizumab concentrations in the study population~     following the last PLEX (or equivalent) procedure.~   "
140815|NCT01211652|"~     The purpose of this study is to assess in general population NSAID and gastroprotective~     agent utilization and compliance in elderly people.~   "
140816|NCT01211639|"~     The purpose of this study is to explore host genetic mutations which may render individual~     subjects more susceptible (or resistant) to developing Progressive Multifocal~     Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid~     (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide~     information about viral genotypes that may be associated with higher pathogenicity, and help~     to identify individuals who may be at higher risk of developing Progressive Multifocal~     Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC~     Virus (JCV).~   "
140817|NCT01211626|"~     The overall study design includes two parts, Part A and Part B.~      Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40~     evaluable healthy volunteers were enrolled in Part A of the study.~      Part B evaluated ANA773 following oral administration to patients with chronic HCV~     infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study~     centers.~   "
140818|NCT01211613|"~     The investigators will be comparing the effectiveness of two types of chiropractic~     manipulation and standard medical care for patients with a recent onset of low back pain.~     The two types of chiropractic treatments being compared will be hands-on (manual)~     manipulation and mechanical-assisted (Activator) manipulation. The standard medical care~     will consist of a medical examination and prescription for over-the-counter~     anti-inflammatory medication.~   "
140819|NCT01211600|"~     To determine whether the rate of wound complications differs based on method of closure of~     skin incision (staples vs. suture) after cesarean delivery.~   "
140820|NCT01211587|"~     The purpose of this research trial is to determine if safinamide (experimental drug) can~     improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The~     word experimental means the trial drug is not approved by Health Authorities (government~     authorities) and is still being tested for safety and effectiveness.~      Approximately one hundred (100) patients will participate in this research trial. The~     research trial will be conducted in approximately thirty (30) medical centers in the~     following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The~     research trial will last until June 2012.~   "
140821|NCT01211574|"~     Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or~     Professionals. The aim of this study is to examine the feasibility and preliminary efficacy~     of health coaching for weight loss.~   "
140822|NCT01211561|"~     Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30~     years, but has never been directly studied in humans. The investigators will directly assess~     selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an~     accepted surrogate marker for CRC.~      ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a~     commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that~     allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like~     polyps or cancers, but can disappear as a person's risk for developing CRC decreases.~      The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or~     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary~     objective is to determine whether selenized yeast supplementation, compared to placebo,~     causes significant reduction of ACF number from baseline levels. The primary endpoint will~     be change in ACF number~   "
140823|NCT01211548|"~     This proposal is for the pilot study that will inform the conduct of a larger prospective~     randomized controlled trial to guide perioperative work up and the cost/utility of CTCA~     (high definition CT coronary angiography.)~   "
140824|NCT01211535|"~     The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact~     lens wearers.~   "
140836|NCT01211379|"~     The investigators overall goals are to adapt, implement, evaluate, and disseminate the~     FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce~     colorectal cancer screening disparities in resource-poor clinical settings. In this program,~     fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible~     patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is~     that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates~     of colorectal cancer screening (CRCS).~   "
141008|NCT01209130|"~     This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered~     by intravenous (IV) infusion to patients with relapsed or refractory hematologic~     malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with~     rituximab.~   "
140825|NCT01211522|"~     The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological~     Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium~     in vulnerable critically ill patients. We and others have shown that delirium is an~     independent predictor of more death, longer stay, higher cost, and long-term cognitive~     impairment often commensurate with moderate dementia. The rapidly expanding aging ICU~     population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical~     ICU patients developing this organ dysfunction. Antipsychotics are the first-line~     pharmacological agents recommended to treat delirium, and over the past 30 years they gained~     widespread use in hospitalized patients globally prior to adequate testing of efficacy and~     safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by~     over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%.~     Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms,~     and the highly publicized increased mortality associated with their use in non-ICU geriatric~     populations. The overarching hypothesis is that administration of typical and atypical~     antipsychotics—haloperidol and ziprasidone, in this case—to critically ill patients with~     delirium will improve short- and long-term clinical outcomes, including days alive without~     acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day~     period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or~     duration of long-term neuropsychological dysfunction; and quality of life at 90-day and~     1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind,~     randomized, placebo-controlled investigation in 561 critically ill, delirious~     medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive~     pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol,~     ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has~     resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.~   "
140826|NCT01211509|"~     Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality~     and morbidity after lung transplantation. Because montelukast has been shown to be of some~     efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow~     transplantation), the investigators would like to test if montelukast can indeed slow down~     the progression of chronic rejection after lung transplantation.~   "
140827|NCT01211496|"~     We are exploring a unique weight-training program for men and women 65 years or older that~     emphasizes high speed training. We believe that the speed at which muscles move may be more~     important to the performance of functional tasks than how strong the muscles are. We are~     comparing velocity training with traditional strength training to determine which method has~     the greatest effects on muscle strength, speed of movement, functional performance and~     physical disability. We believe that higher speed training will improve these measures to a~     greater extent than simply training for increased muscle strength.~      Aging also results in loss of bone mass, which increases the risk for falls and fractures.~     Strength training also has been shown to maintain bone mass in the elderly, but no studies~     have examined high velocity resistance training and maintenance of bone mass. We believe it~     is important to examine this aspect of velocity training before recommendations can be made.~   "
140828|NCT01211483|"~     This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are~     receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if~     adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung~     cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the~     treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib +~     U3-1287.~      The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve~     survival in subjects with advanced non-small cell lung cancer who failed the first~     treatment.~   "
140829|NCT01211470|"~     The study investigates the safety and efficacy of PMX-30063 in patients treated for acute~     bacterial skin and skin-structure infection (ABSSSI).~   "
140830|NCT01211457|"~     This is an open label, phase I/II study to evaluate the safety and efficacy of sapacitabine~     administered in alternating cycles with decitabine in elderly patients with newly diagnosed~     Acute Myeloid Leukemia (AML).~   "
140831|NCT01211444|"~     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of~     the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to~     help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).~   "
140832|NCT01211431|"~     The goal is to compare the quality of post-cesarean analgesia, the side effects and the~     incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or~     with a continuous intra-wound solution including both ropivacain and diclofenac~     (experimental treatment).~   "
140833|NCT01211418|"~     Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved~     pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a~     challenge to scientists and clinicians. Psychosocial interventions known as behavior~     therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent~     need to further improve treatment outcomes, especially during early recovery and the~     protracted withdrawal phase of the treatment since many patients drop out or relapse during~     this phase. Our clinical experience and studies suggest that integrative Meditation (IM)~     helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit~     of IM is well supported by tension-reduction theory and attention-networks framework in~     addiction treatment. The proposed study will implement a therapy development study to add IM~     as a self-care component to the current outpatient treatment of cocaine addiction to improve~     treatment outcomes.~      The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial~     with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine~     addicts and to determine effect size of IM-augmented treatment in comparison with~     Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment~     as usual (TAU), thereby facilitating future larger scale therapy development study; and 2)~     to examine the changes in attention networks and negative mood as possible mediators of~     treatment outcomes between the two groups.~   "
140834|NCT01211405|"~     This study is designed to provide information on whether psychotherapy (talk therapy)~     combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress~     disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of~     MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be~     assigned at random, and the investigators and the subject will not know the dose given. The~     researchers will also investigate depression symptoms. The researchers believe that the full~     dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.~   "
140835|NCT01211392|"~     Prospective study where magnetic resonance imaging is compared to dual-energy computed~     tomography for the detection of bone marrow changes.~   "
141069|NCT01208389|"~     The study is a follow-on to a Phase 1 dose-escalation and safety study.~   "
140837|NCT01211366|"~     Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be~     performed safely without increased risk of bleeding or release of inflammatory mediators.~     This will reduce the need for allogeneic blood products as well as crystalloid and colloid~     infusions and thus decrease the length of ventilation and intensive care duration for these~     infants.~   "
140838|NCT01211353|"~     The objective of this research is to better understand how to reduce hazardous drinking~     among OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered~     preventative program.~   "
140839|NCT01211340|"~     The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this~     project is to implement and test this promising intervention in three hospice programs. The~     mixed methods evaluation of this RCT will provide evidence-based data for a tested~     intervention manual that hospice staff members can use to integrate the intervention into~     their practices. We will rigorously test the effectiveness of the ACTIVE intervention (RQ1).~     We will investigate whether the assessment of the ICG perception of pain management will~     identify those who will benefit most (RQ2) and whether changes in the perceptions of~     informal caregivers will result in improvement of patient pain (RQ3). With a cost effective~     intervention (RQ4, 5) and an understanding for a translation plan (RQ6, 7), involving the~     informal caregivers and patients (when able) on the IDT team can become the standard of~     care. This intervention may have the potential to influence not only hospice care but also~     care for other patients experiencing chronic or terminal pain.~   "
140840|NCT01211327|"~     Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory~     disease of unknown cause. It is a fairly common disease in hot, dry environments,~     representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology~     seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist~     for years with an important visual morbidity and social impact. Corneal changes (e.g.~     corneal ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical~     steroid therapy remains the current standard treatment, but in developing countries its use~     often is chronic and not medically supervised, potentially leading to bacterial infections,~     steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack~     the power to control a flare-up. Topical cyclosporine has the potential to offer an~     efficient but safer alternative to steroid drops in the management of VKC in an African~     setting. Its safety and efficiency in the management of vernal keratoconjunctivitis have~     been described in several uncontrolled studies and double-blind, placebo-controlled trials,~     but those studies were relatively small and involved populations outside Africa with~     predominantly palpebral and mixed forms of VKC. Controversy still remains on the efficiency~     of cyclosporine in severe forms of allergic conjunctivitis like VKC. We therefore undertake~     a larger prospective randomized double-masked, standard treatment controlled clinical trial~     in Central Africa to compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops,~     solved in olive oil vehicle, with that of steroid drops in predominantly limbal forms of~     VKC. During 4 weeks the participants will be randomised to either cyclosporine or~     dexamethasone as attack treatment for VKC. The 4 weeks thereafter all participants will~     receive chromoglycate drops as maintenance treatment. Additional objectives are to document~     any difference in rebound phenomenon while on chromoglycate during the maintenance phase~     between the 2 treatment groups and to evaluate safety and tolerance of the test medication.~   "
140841|NCT01211314|"~     Treatment and control of hypertension is still insufficient. About 50% of the patients~     remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an~     important reason for not achieving blood pressure. Several studies have shown that use of~     fixed combinations improve compliance significantly, by reducing the number of pill's~     intake.~      This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg +~     lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.~   "
140842|NCT01211301|"~     The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a~     food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a~     26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be~     enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based,~     reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52~     weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite~     sensations.~   "
140843|NCT01211288|"~     The purpose is to place implants in HIV positive and HIV negative patients, follow patients~     over 3 years period of time, to evaluate how well dental implants perform in HIV-positive~     patients versus HIV-negative patients.~   "
140844|NCT01211275|"~     The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis~     inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients~     with mesothelioma~   "
140845|NCT01211262|"~     IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The~     drug is designed to target melanoma cells and stimulate immune cells to kill them. This~     trial is designed to establish the level of drug that can be given to a patient that is~     tolerable. It also designed to establish the best dosing schedule for the drug and to look~     for signals that the drug is working as intended.~   "
140846|NCT01211249|"~     Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment~     with methotrexate will receive once daily two capsules containing either GLPG0259 (25~     mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will~     be examined for severity of disease, as well as for any adverse effects that may occur. If~     needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.~      Part B: If results of Part A suggest test medication to have a therapeutic advantage over~     placebo and to be well-tolerated, more patients will be recruited for Part B, where various~     dosages will be assessed. These dosages will be established based on results from Part A.~   "
140866|NCT01210989|"~     Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide.~     Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a~     progressive course and may result in liver cirrhosis and liver cancer. However, there is yet~     proven treatment for this disorder. In cell line and animal studies, we have shown that~     Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid~     accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver~     diseases, but the efficacy in NASH has not been confirmed in humans.~      This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH~     will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy.~     Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of~     Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue~     Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be~     further analyzed.~   "
140847|NCT01211236|"~     The main objective of the trial was to study the efficacy of bagged larvae on wound~     debridement in comparison to classical treatments. The secondary outcome was to assess wound~     healing, treatment related pain, microbiological modifications, adverse events, comfort of~     the dressing and duration of wound care. We performed a randomized, double-blind,~     multicenter, controlled, prospective phase III trial in three referral institutional centers~     of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a~     non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure~     index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´~     hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged~     larvae twice a week) or classical treatments (mechanical debridement and classical dressings~     performed three times a week). At discharge, classical dressings were applied and a~     follow-up visit performed at D30. Main outcome measure was the comparison of the reduction~     of fibrin percentage on wounds treated with MDT and classical treatments at D15. The~     percentages of fibrin were measured using a computerized planimetry software package, Canvas~     (ACD Systems, British Columbia, Canada), which enables the quantification of color surface~     variations in a wound after manual delimitation (using a mouse) on a series of photographic~     images.~   "
140848|NCT01211223|"~     • Background: Peridontitis is a group of diseases with complex bacterial etiology that~     affects a large proportion of the Chilean and worldwide population. Its treatment, based on~     an anti-infective mechanical therapy including scaling and root planning procedures, has~     been highly effective in numerous short and long term clinical trials. The use of adjunctive~     systemic antibiotics has shown significant improvements in the initial therapy results of~     specific periodontal disease types or patient profiles.~      The synergic combination of Metronidazole plus amoxicillin has been widely and successfully~     used for the treatment of aggressive and severe chronic periodontitis, demonstrating~     additional benefits in clinical and microbiological parameters over scaling and root~     planning alone. However, and despite its proven efficacy, there is a lack of evidence that~     evaluates the impact of antimicrobials intake at different times of the mechanical~     treatment, emphasizing the necessity of a study that compares, simultaneously, the variation~     of the adjunctive antibiotic effects when they are administered in different moments through~     the periodontal therapy course.~   "
140849|NCT01211210|"~     RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage~     2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need~     radiation for local control after total mesentery excision being applied in routine practice~     is still unknown. And whether new drugs adding in can achieve better local and distant~     control is worth investigating.~      PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX~     based radiation or FOLFOX alone, comparing them to see how well they work when given before~     surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet~     known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more~     effective in treating rectal cancer.~   "
140850|NCT01211197|"~     The objective of the current study is to determine the relative bioavailability of a BI~     10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and~     metformin when administered together and to assess the effect of food on the bioavailability~     the fixed dose combination tablet~   "
140851|NCT01211184|"~     The purpose of this study is to determine whether fluid or glucose administration before hip~     replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and~     disturbances in carbohydrate metabolism.~   "
140852|NCT01211171|"~     In the light of ONTARGET and TRANSCEND studies results, it would be interesting to~     investigate the real-life telmisartan treatment tolerability. It is well known and accepted~     that the Real-life setting is much more adequate to reflect the antihypertensive and safety~     properties of the drug in comparison to the organized and scheduled setting of the clinical~     trial. Because there are not much data on the cough in relation to telmisartan, therefore it~     would we worth to observe the cough frequency and general treatment tolerance in patients~     treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.~   "
140853|NCT01211158|"~     When patients come to the Emergency Department with injuries and infections they often need~     to have painful procedures performed that are essential to allowing them to recover. To~     accomplish this, doctors often use procedural sedation. This involves giving medications~     through an intravenous line in order to relieve the patient's pain and to make them drowsy~     while the painful procedure is being performed. This allows the medical staff to perform~     necessary procedures to patients without causing pain and anguish.~      There are several types of medications and combinations of medications that are used for~     procedural sedation. Each medication has its advantages and its disadvantages. Consequently,~     research is necessary to determine which medication or combination of medications is the~     most effective and the safest. This study will compare the use of one drug (Propofol) versus~     the use of a combination of Propofol with another drug (Ketamine). Both of these drugs are~     already used for procedural sedations in the emergency department but it is not known which~     of them is the best or the safest.~      The investigators believe that the combination of ketamine and propofol together will work~     as good or better than propofol alone and be a safer option as well. Propofol is a well~     known sedative that is used in many emergency departments and the clinical experience with~     it has been very good because it acts quickly and wears off quickly. However, propofol is~     not a good pain-killer and it can also cause patients to stop breathing. This is why~     monitoring a patient's breathing and vital signs is essential for any procedural sedation.~     It is known that ketamine is a good pain-killer and helps patients to maintain their~     breathing. Doctors sometimes use ketamine alone for procedural sedation but patients take a~     very long time to wake up when ketamine only is used.~      Thus, the investigators think that by combining ketamine with propofol the investigators can~     perform painful procedures using procedural sedation without causing patients to stop~     breathing as often as with propofol alone. Also, the ketamine the investigators use will~     help treat their pain and make them more comfortable.~      The investigators plan to enroll 284 patients over the course of about one year. The primary~     outcome of adverse respiratory events, as well as the secondary outcomes will be assessed~     during the course of the sedation and recovery period, approximately one hour. Quality of~     life score and pain will be assessed by telephone interview 3 days after the procedure.~   "
140854|NCT01211145|"~     The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age~     12-17 years) with migraine headaches feel better. This will be done by comparing 3 different~     doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).~   "
140898|NCT01210573|"~     To observe and document ventilation parameters in the advanced heart failure population,~     through the course of illness, which often includes cardiac resynchronization therapy (CRT),~     left ventricular assist device (LVAD), and transplant. Findings from this cohort are~     anticipated to be of sufficient interest to the scientific community to merit publication~     and are likely to provide preliminary data for future hypothesis generation and subsequent~     prospective, randomized controlled trials.~      A compact, inexpensive apparatus has recently become commercially available for performing~     sub-maximal exercise testing (SHAPE Medical, St Paul, MN), including gas exchange analysis~     and will be used in this study. This apparatus is not investigational.~   "
140855|NCT01211132|"~     This simple technique of attaching a transparent cap to the tip of the colonoscope has been~     evaluated in Japan for improving the detection of polyps and cecal intubation but has not~     been formally evaluated in the US and other western countries. In one study (19), the polyp~     detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04).~     Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a~     recently published study, a variation of the cap called the transparent retractable~     extension device was used (21). Overall, the number of adenomas detected were significantly~     higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by~     Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient~     (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used~     cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as~     failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the~     cap, cecal intubation was achieved in 94% of patients and this proved to be an effective~     rescue method for failed or difficult colonoscopy. The major appeal of this technique is~     that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there~     are no reported complications from this. If found to be effective in increasing the polyp~     yield it has the potential to being incorporated by busy gastroenterologists in their day to~     day clinical practice. These features and the preliminary data from Japan merit the~     evaluation of this promising technique in the US.~   "
140856|NCT01211119|"~     Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by~     suture repair when it is possible. Recently, the investigators have successfully developed~     and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage~     defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to~     the development of microvascularization and enables local and progressive delivery of growth~     factors providing unique properties for tissue remodeling and wound healing. The advantages~     of using PRF implantation include no transplant rejection and no need to perform second~     operation. Knee meniscal repair using PRF has not been reported before. The aim of this~     study is to investigate whether PRF implantation can facilitate regeneration process of~     meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal~     tears.~      A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus)~     will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after~     partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C~     (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with~     surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.~      The investigators believe that PRF enables to facilitate regeneration of meniscectomized~     knee, and T2-map MRI enables monitoring healing process of meniscal tears.~   "
140857|NCT01211106|"~     The investigators are examining different treatment strategies of helping patients with PTSD~     and addiction.~   "
140858|NCT01211093|"~     Whole body vibration has been found to be useful in promoting bone health, balance, and~     muscle performance in older adults. The overall aim of the proposed study is to determine~     whether whole body vibration (WBV) has immediate beneficial effect in neuromotor performance~     in patients with stroke. It is hypothesized that a single session of WBV will induce~     significant improvement in leg muscle strength in people with chronic stroke.~   "
140859|NCT01211080|"~     Propranolol use for infancy hemangiomas is of world wide interest due to low cost and~     presumed efficacy. The investigators hypothesized that the drug ist highly active against~     growing hemangiomas in problematic sites and that there are little side effects.~      This observational study was undertaken in an uncontrolled fashion to determine sample size,~     design and and tools for a later randomized controlled trial on propranolol versus physical~     therapy (i.e.cryotherapy) which is the most prevalent treatment for the condition. During~     this initial series side effects and relevant design aspects became evident which warrant~     expedited reporting.~   "
140860|NCT01211067|"~     The histology of the internal inguinal ring in patients with indirect hernia submitted to~     elective surgery was studied. In contrast with recently published studies, the investigators~     believe that histological findings of the internal inguinal ring would reflect those~     associated and expected with normal aging.~   "
140861|NCT01211054|"~     Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old~     population (> 60 yrs) in Korea.~      List to do~        1. History taking~        2. physical examination~        3. Routine blood test~        4. All spirometric data~        5. In subgroup: further evaluation of allergic airway disease~   "
140862|NCT01211041|"~     Candida albicans is the most common and important clinical fungal pathogen. Our previous~     surveillance disclosed that fluconazole could induce different morphological changes in~     clinical strains. Our current study on C. albicans causing candiuria disclosed that renal~     insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of~     treatment failure. However, we also found results of E-test drug susceptible test could not~     predict outcome. Hence, retrospective analysis of 31 months period, cases that had C.~     albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological~     study and potential virulent gene analysis.~      This study is designed to clarity the clinical meaning of morphological form and virulent~     genes on candidemia. To do this study is probably helpful for treatment of candidiasis.~   "
140863|NCT01211028|"~     The main purpose of this study is to evaluate the safety and feasibility of regenerative~     therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in~     patients with critical leg ischemia.~   "
140864|NCT01211015|"~     Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary~     disorders~      Measurement:~        1. Unfolded protein responses (UPRs) in blood (PBMCs)of patients~             1. CHOP~             2. GRP 78 and so on~        2. Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls~             1. CHOP~             2. GRP 78 and so on~   "
140865|NCT01211002|"~     It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with~     recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B)~     non-small cell lung cancer.~   "
141238|NCT01206114|"~     A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009~     H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing~     the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.~   "
140867|NCT01210976|"~     Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass~     grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to~     describe the haemodynamic effects of levosimendan in comparison to placebo in patients~     undergoing elective aortic valve replacement (AVR) together with coronary artery bypass~     grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and~     will be carried out in Heart Center.~      Twenty four patients will be randomized into two groups of 12. The treatment group will~     receive 24 hour infusion of levosimendan preoperatively where as the placebo group will~     receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be~     measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn,~     Estonia) is used for the measurement of whole-body impedance cardiography derived heart~     rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and~     extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be~     carried out as in standard care. Echo cardiography will be done pre- and postoperatively.~     Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24~     hours.~   "
140868|NCT01210963|"~     Investigation of the occurrence of possible corneal swelling after continuous Intraocular~     pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.~   "
140869|NCT01210950|"~     Limb-length discrepancy can be due to many causes. These are divided into three groups:~     congenital (from birth), developmental (from a childhood disease or injury that slows or~     damages the growth plates), and posttraumatic (from a fracture that leads to shortening of~     the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe~     lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift~     greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in),~     shortening of the long leg can be considered, especially for tall persons. For growing~     children, this can be easily accomplished with a small, minimally invasive, uncomplicated~     procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone~     marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of~     bone regeneration during distraction osteogenesis.~   "
140870|NCT01210937|"~     Carotid endarterectomy has been proven effective in prevention of cerebral vascular events~     in patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But~     during the surgery, when the carotid artery is clipping, the patient will have the chance to~     have hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce~     the risk of death and nonfatal stroke in patients .~   "
140871|NCT01210924|"~     This is an observational cohort in pediatric HIV patients in China. Children who receive~     antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1.~     To establish simpler and smarter pediatric antiretroviral therapy in China including both~     first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms~     of immunoreconstitution in HIV-infected children using the data and samples from the~     pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical~     research network based on the pediatric antiretroviral cohort.~   "
140872|NCT01210911|"~     Pancreatic cancer patients have one of the worst prognoses among all cancer types with a 5~     year survival rate of less than 5%. Despite significant changes during the last decade in~     our molecular knowledge on this disease, the prognosis and management of pancreatic cancer~     have remained unchanged. With the advances in molecular biology, newer biologic agents such~     as erlotinib, are adding some benefit to the conventional cytotoxic agents. There is a~     growing body of literature suggesting that type 2 diabetes mellitus (DM) may be associated~     with the development of pancreatic cancer, but this association is complex. Because various~     DM medications can affect directly the key factors mediating the association between DM and~     pancreatic cancer, understanding the effect of anti-diabetic therapies on pancreatic cancer~     is a critical step in fully characterizing the role of type 2 DM in the development of~     pancreatic cancer. Indeed, two epidemiologic studies have found that diabetic patients~     treated with metformin were less likely to develop cancer, but those treated with insulin~     were more likely to die of various kinds cancer. Not only does metformin ameliorate~     hyperglycemia and hyperinsulinemia, both of which are associated with the adverse impact of~     DM on cancer, metformin also has direct metabolic effects through activation of adenosine~     monophosphate-activated protein kinase (AMPK). AMPK regulates many metabolic enzymes and~     also inhibits the mammalian target of rapamycin (mTOR) pathway via phosphorylation and~     stabilization of the tumor suppressor gene TSC2. But there is an intensive cross-talk~     between various pathways. Inhibition of the phosphoinositide 3-kinase (PI3K)/Akt pathway, of~     which mTOR is one of the effector proteins, for instance may result in escape via the~     mitogen-activated protein kinase (MAPK) pathway and vice verse. Indeed, epidermal growth~     factor receptor (EGFR) activation leads to activation of the MAPK pathway and the PI3K~     pathway. Thus, since it is clear that blocking one pathway will not always be sufficient to~     produce a response in the presence of other activated pathways, the best change of success~     will be realized when using a combination of agents that inhibit separate pathways known to~     be critical to the survival of the tumour. In line with these observations, combining a~     small molecule against the EGFR and inhibition of the PI3K pathway by metformin might~     account for potential candidates of the above combinatorial approach. Therefore, in this~     study, the investigators want to determine the activity and safety of concurrent~     interruption of the MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinib~     and metformin, combined with gemcitabine in patients with metastatic pancreatic cancer.~   "
140873|NCT01210898|"~     This study will evaluate the safety and immunogenicity of children previously primed in the~     V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.~   "
140874|NCT01210885|"~     The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity~     of two doses of 4 different investigational MenABCWY combination vaccine when administered~     to healthy adolescents aged 11-18 years.~   "
140875|NCT01210872|"~     RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction~     with care may help doctors plan the best treatment and help patients live more comfortably.~      PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients~     with head and neck cancer treated with radiation therapy.~   "
140876|NCT01210859|"~     The purpose of this study is to check whether antimuscarinics that usually broadly used in~     the treatment of overactive bladder symptoms are effective in the treatment of those~     symptoms after insertion of ureteral stents. In order to study the efficacy of the treatment~     of OAB symptoms in stented patients the investigator will use a suitable questionnary.~   "
140877|NCT01210846|"~     The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG~     morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship~     between any observed changes in cardiac repolarization (defined by QTcF duration) and the~     serum concentration of tivozanib.~   "
140899|NCT01210560|"~     To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of~     tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals~     of this trial are two-fold:~        1. To directly compare the immediate release (IR) and MR formulations~        2. To determine the dose range and dose regimen for MR (dose finding)~   "
140878|NCT01210833|"~     HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It~     is composed of a glove with optic sensors detecting the movements of the wrist and the~     fingers with a biofeedback software designed to evaluate and then to exercise the hand~     movements through supplying a variety of computer graphic patterns.~      The HandTutor has been used and tested with a stroke population, and it seems potential to~     be used with hand injuried population. As a first step, it is important to investigate the~     characteristics of the system and how it is matching the hand injuried population.~      The purpose if this study is to characterize the HandTuror system and the focused objectives~     are:~        1. To examine the test-retest reliability of the system when measuring the range of motion~          (ROM) of the the fingers among healthy people (control group).~        2. To examine the correlation between the ROM measured by the HandTutor and the ROM~          measured by conventional assessment tools (goniometer).~        3. To examine the ability of the system to distinguish between healthy people and hand~          injured people.~        4. To examine the correlation between the performance in the HandTutor (in the games~          part), and the performance in functional activities.~        5. To examine the participants feedback for using the HandTutor (degree of enjoyment).~   "
140879|NCT01210820|"~     The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond~     laser is a safe procedure.~   "
140880|NCT01210807|"~     The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens~     (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general~     postoperative outcomes of the One-Piece Tecnis Multifocal lens.~   "
140881|NCT01210794|"~     The influence of different food componente on zinc absorption in young adults consuming zinc~     fortified porridge's prepared from maize, beans and sorghum: a series of six similar~     randomized, single-blind studies.~   "
140882|NCT01210781|"~     Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's~     disease and other indications. A common target for stimulation is the subthalamic nucleus~     (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical~     improvement.~      The project aims to describe the variability of target coordinates in the patient group and~     to relate it to clinical outcome as documented in standardized questionaires.~        -  Trial with surgical intervention~   "
140883|NCT01210768|"~     Primary objective:~        -  To evaluate the disease-free survival (DFS) in the two randomized arms after therapy~          with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer~      Secondary objectives:~        -  To assess the overall survival (OS)~        -  To establish the safety profile by assessing the toxicities and tolerability~        -  To assess the quality of life (QoL)~        -  To evaluate survival correlation with biomarkers expression.~   "
140884|NCT01210755|"~     The purpose of this study is to evaluate whether the effect of the two new anticoagulants,~     Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For~     Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex~     concentrate (PCC), recombinant activated coagulation factor VII, and activated~     prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific~     Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from~     healthy male volunteers.~   "
140885|NCT01210742|"~     Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the~     research into OA, to date, concentrates on predisposition, genetic and cellular aspects and~     the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early~     OA have great difficulty in recommending an appropriate and efficacious intervention.~      The first line of treatment for patients with early OA is exercise, self-management and~     weight loss. These tools are suggested to minimize the need for higher risk treatments such~     as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using~     intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To~     date, the ideal patient for viscosupplementation has yet to be defined. It is not known~     whether incorporation of viscosupplementation into the overall clinical management will have~     beneficial influence for patients with early OA of the knee.~      This study will generate rigorous pilot data to assess the need and inform a larger~     randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study~     will be a single blind randomised RCT. 60 patients with documented early OA will be~     randomised into one of two groups; Group V will undergo one shot viscosupplementation~     using Synvisc One in addition to routine physiotherapy management for knee OA. Group No V~     (control) will have no viscosupplementation but will undergo similar routine management~     including physiotherapy management for knee OA. Outcome measures will include walking pain~     (The Western Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC~     score, Oxford Knee Score (OKS), American Knee Society score (AKS), complications, activity~     level and patient satisfaction. Health economics will also be evaluated. Measurements will~     be recorded pre-intervention and at six months following treatment.~      The risks associated with viscosupplementation are minimal. Considering the limited~     resources currently available in health care, if the latter is shown to have higher~     effectiveness than physiotherapy alone, in addition to patient benefit, there will be~     important health economic implications.~   "
140886|NCT01210729|"~     The objective of this study is to collect data on the use of the SOLITAIR FR device for~     treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether~     the application of SOLITAIR is a safe and feasible method for interventional recanalization~     of large vessels with favorable patient outcome in acute stroke therapy.~   "
140887|NCT01210716|"~     This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma~     Exchange (TPE) is prescribed by their physicians.~   "
140888|NCT01210703|"~     Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA)~     and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to~     describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure)~     in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with~     Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures.~     The investigators also intend to determine if pressure determined by Polysomnography in OSAS~     patients cause some type of different change in AP graphic.~   "
140889|NCT01210690|"~     The purpose of this observational study is to broaden the knowledge of the known safety and~     efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than~     12 months when treated according to routine clinical practice. Their data will be collected~     until they reach the age of 13 months.~   "
140922|NCT01210261|"~     Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by~     intermittent partial and/or complete upper airway obstruction during sleep. The~     participants, naive to nasal continuous positive airway pressure (CPAP), recently diagnosed~     with OSA, will undergo two automatic CPAP titration studies with collection of~     polysomnographic (PSG) data. The data will be analysed to assess effectiveness of~     Compumedics auto-CPAP device in the normalisation of sleep disordered breathing in OSA~     patients, with respect to another auto-CPAP device.~   "
140890|NCT01210677|"~     There are no published clinical consensus guidelines on the treatment of cardiac~     sarcoidosis. Corticosteroid therapy is advocated by some experts, but is based on small~     observational studies, with varied clinical response.~      Objectives of this trial:~        -  to systemically assess the response of patients with cardiac sarcoidosis, to treatment~          with corticosteroids~        -  to identify the clinical predictors of response to treatment with corticosteroids~        -  to assess the utility of imaging with PET and MRI to predict response to treatment with~          corticosteroids~        -  to determine the prevalence of cardiac sarcoidosis in young patients with unexplained~          heart block and in patients with unexplained dilated cardiomyopathy associated with~          ventricular tachycardia~        -  to use the data from this pilot study to assess the need, feasibility, and sample size~          for a larger multicentre trial~   "
140891|NCT01210664|"~     The investigational therapy under study in this trial, regulatory T cells (Tregs), offers~     the hope of stabilizing further destruction of insulin producing beta cells in type 1~     diabetes. Tregs are a specialized subset of T cells that function to control the immune~     response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive~     transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset~     diabetes. The primary purpose of this Phase 1 study is to assess the safety and feasibility~     of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in~     patients with type 1 diabetes (T1DM) to support dose selection for a future efficacy trial.~     The study also aims to assess the effect of Tregs on beta cell function as well as on other~     measures of diabetes severity and the autoimmune response underlying T1DM.~   "
140892|NCT01210651|"~     This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility~     of hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in~     San Francisco meeting criteria for major depression of mild-to-moderate severity, per~     structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI).~     At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy,~     herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty~     participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8~     weeks. Eighteen participants were randomized to 90-minute attention control education groups~     twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a~     university clinic. Primary outcome was depression severity, measured by BDI scores every 2~     weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were~     self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES)~     and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed~     whether change in outcome measures would be statistically comparable between the two~     intervention groups.~   "
140893|NCT01210638|"~     The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10~     mg Tablets under fasting conditions~   "
140894|NCT01210625|"~     The investigators hypothesize that daily oral intake of starch-entrapped alginate~     microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal typical~     side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal~     vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents;~     and promote gut health by improving bowel habit, by changing the gut microbiota and~     increasing production of short chain fatty acids, especially butyrate, in the colon and~     decreasing production of protein putrification (prebiotic effects).~   "
140895|NCT01210612|"~     Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique~     style of socks that have become popular in Japan among athletes that could also improve~     postural control. The purpose of the study is to determine the effectiveness of five-toed~     socks on dynamic postural control in individuals with and without chronic ankle instability.~   "
140896|NCT01210599|"~     INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect~     in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful~     conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing~     spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV~     pamidronate in the management of chronic low back pain (CLBP), a worldwide public health~     problem in terms of lost workdays, treatment costs, and suffering.~      The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study~     participants were divided among four study phases. Each group received IV placebo or~     escalating doses of IV pamidronate.~      STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study~     for the treatment of patients with CLBP with IV pamidronate. The study was first conducted~     at Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai~     Medical Center , NY for the remaining groups.~      PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV~     pamidronate treatment protocol for CLBP in a Phase III trial. Primary study aims were safety~     and average daily pain. Subjects used an electronic diary (LOGPAD) to record their daily~     adverse events (AEs) and their baseline and post-treatment average pain on the 0-10~     numerical rating scale (NRS).~      STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary~     outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain~     score dropped ≥2 points or ≥30%). Because there was no statistical difference in these two~     outcomes among the 4 placebo groups, all placebo patients were combined (Comb PL) in the~     subsequent analyses. Primary analytic tool was mixed model for repeated measures (MMRM),~     assuming autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI~     interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes~     (Response rates and Patient Global Impression of Change - PGIC). The main objective was to~     assess whether the changes in outcome from baseline or the response rates were the same~     across the study phases, while adjusting for baseline values and time effect. Least square~     means were contrasted. Interaction between time and study phases were also tested to see if~     the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis)~     tests were performed for cross-sectional group comparison, including baseline.~   "
140897|NCT01210586|"~     This study investigated whether being on transdermal hormone replacement therapy (HRT)~     influenced smoking cessation variables in postmenopausal women undergoing short-term~     abstinence from cigarettes. Women were recruited into two groups according to their~     pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT~     group had their prior medication replaced with a standard 0.1 mg estradiol transdermal~     system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment,~     participants continued smoking as usual for one week, at which time baseline measurements~     were taken. For the remaining two weeks, participants were instructed to quit smoking. They~     were provided with smoking cessation counseling and monitored for abstinence. Data were~     collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal~     Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and~     Reaction Time Test.~      Part II is identical to Part I, except it randomizes participants to use nicotine patch or~     not.~   "
140900|NCT01210547|"~     The goal of this project is to reduce the radiation exposure in orthodontic patients by the~     use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital~     dental models, three-dimensional photograph) The first step in this process is to develop~     and validate an orthodontic analysis able to assess craniofacial proportions, dental,~     skeletal, and facial soft tissue. The investigators working hypothesis is that data from~     three-dimensional facial photographs and from digital dental casts can be registered~     accurately and consistently, and the diagnostic information about tooth position and facial~     soft-tissue derived from them are comparable to x-ray derived data~   "
140901|NCT01210534|"~     Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.~   "
140902|NCT01210521|"~     The purpose of this study is to determine the effects of vitamin D3 on severe asthmatic~     patients. Vitamin D3 may alter the response of these patients to conventional steroid~     therapy, making them more responsive to the latter form of treatment. Patients will be~     treated daily with an oral dose (2,000 IU) of vitamin D3 for one month and their clinical~     and serological parameters, and immune function, will be evaluated. Results from pre- and~     post-vitaminD3 treatment will be compared.~   "
140903|NCT01210508|"~     70% of all cancer patients develop some form of visceral (internal organs) or skeletal~     metastases (spread of disease). Approximately one third of cancer patients develop~     metastases to the spinal column. The prognosis once spinal metastases have been diagnosed~     and the most appropriate treatment still remains controversial. To date there is no one good~     diagnostic tool to predict survival and/or outcome after radiotherapy or surgical~     intervention.~      Tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate~     indications for surgery and predict outcome in patients with metastases to the spinal~     column. Six variables are measured to calculate this score: general medical condition,~     number of extraspinal metastases, number of vertebral metastases, status of metastases to~     the major internal organs, primary tumor type, and presence of a neurologic deficit. This~     scoring system has been gaining acceptance in literature. In 1998, Tokuhashi, et al,~     modified this scoring system by diversifying the tumor types into six categories. After a~     retrospective analysis Tokuhashi reported that patients with scores less than or equal to 8~     will die of their disease within 6 months and those with scores of 12 or greater will~     survive an average of 12 months or more.~      The purpose of this study is to determine 1) the Tokuhashi score's validity in predicting~     survival after developing spinal metastases, 2) the relationship of treatment on survival~     after detecting spinal metastases in relation to the Tokuhashi score. Patients will be~     enrolled into the study and followed prospectively for as long as possible regardless of~     intervention.~      There will be three groups based on their Tokuhashi score, each group will require~     approximately 163 subjects statistically.~   "
140904|NCT01210495|"~     The study is designed to demonstrate that axitinib plus best supportive care is superior to~     placebo plus best supportive care in prolonging survival in patients with advanced~     hepatocellular carcinoma.~   "
140905|NCT01210482|"~     The objective of this investigation is to determine the following items in all patients~     receiving Torisel for a certain period after marketing:~        1. Confirmation of efficacy and safety for medical practice use.~        2. Investigation of factors that may influence the incidence of adverse events~          (Particularly priority investigation items).~        3. Investigation of the incidence status and the risk factors for interstitial lung~          diseases.~   "
140906|NCT01210469|"~     The purpose of this study was compare the efficacy of two exercise programs - the first~     consisting of balance training and muscle strength and the second consisting of balance~     training and muscle stretching exercises - to improve postural control in elderly women with~     osteoporosis.~   "
140907|NCT01210456|"~     Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum~     creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum~     creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of~     intravascular contrast administration in the absence of any alternative causes, or a~     reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than~     six hours.~      It is the common cause of new hospital-acquired renal insufficiency. The occurrence of CIAKI~     may be influenced by pre-existing renal insufficiency, diabetic nephropathy, dehydration,~     congestive heart failure, concurrent administration of nephrotoxic drugs, or the dose and~     type of contrast media used. Previous studies have shown the independent effectiveness of~     several agents in preventing CIAKI.~      Even now, hydration is crucial for preventing CIAKI. Since CIAKI is presumed to be caused by~     free radical generation, N-Acetylcysteine, which is a potent free radical scavenger, is~     shown to be effective in preventing nephropathy. At the same time, because free radical~     formation is promoted by an acidic environment, bicarbonate, which alkalinizes renal tubular~     fluid, has been shown to reduce renal involvement.~      These days, some studies have shown that hydration with sodium bicarbonate plus~     N-Acetylcysteine was effective and safe in the prevention of CIAKI. In these studies,~     bicarbonate was used for both alkalinizing renal tubular fluid and hydration. However, if we~     want to do hydration, we can use saline and if we want to alkalinize renal tubular fluid, we~     might use bicarbonate by bolus injection.~      Actually, bicarbonate for hydration is prepared at sterile preparation room in a hospital,~     which is very cumbersome procedure and increase in cost. This is one of the reasons that~     bicarbonate for hydration use does not become common with wide clinical application.~      In past issues, though it differs depending on the level of the renal dysfunction, the~     probability of CIAKI was 8-33% when hydration was administered, 5-15% when hydration and~     N-Acetylcysteine were administered, and 1.8-1.9% when bicarbonate and N-Acetylcysteine were~     administered.~      Thus, we can hypothesize the combination of N-Acetylcysteine and bicarbonate will play a~     complementary role in preventing contrast-induced nephropathy.~      This is the rational for this study.~   "
140908|NCT01210443|"~     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were~     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,~     Canada and Australia. In this study, the long-term safety and efficacy after administrations~     of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication~     will be investigated in Japanese PAH patients.~   "
140909|NCT01210430|"~     The investigators study will determine how often blood flow regulation abnormalities and~     abnormalities of sympathetic regulation produced by nitric oxide, angiotensin-II, and~     oxidative stress occur in POTS and the mechanism(s) of POTS in individual patients. Specific~     causes for POTS may vary from patient to patient. Patients will be compared to healthy~     control subjects. There is a treatment arm with a medication (losartan) that reduces the~     binding of angiotensin and increases NO. If the investigators know the specific biochemical~     mechanism the investigators may be able to offer further specific treatments to specific~     patients.~   "
140923|NCT01210248|"~     The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel~     metabolite in plasma and platelet inhibition status.~   "
141239|NCT01206101|"~     This trial is conducted in Europe and North America. The aim of this trial is to investigate~     if liraglutide treatment can increase the proportion of insulin-independent subjects one~     year after islet cell transplantation who required only one (single-donor) islet cell~     transplant.~   "
140910|NCT01210417|"~     In the prehospital setting it would be helpful to assess primary changes in central blood~     volume or preload (venous return, stroke volume, diastolic ventricular volume) that occur~     during the stability phase following injury when regulatory mechanisms are still~     functioning.~      Obviously in this setting a non invasive bedside beat-to-beat index would be helpful.~      Pulse Transit Time (PTT) is the sum of Pre-Ejection Period (PEP), the time interval between~     the onset of ventricular depolarization and the ventricular ejection, and Vascular Transit~     Time (VTT), the time it takes for the pulse wave to travel from the aortic valve to the~     peripheral arteries (Obrist et al. 1979). PEP variations are known to correlate with~     reductions in central blood volume induced by head-up tilt (Chan et al., 2007b, 2008). The~     same authors also demonstrated that PTT variations follow closely PEP variations and~     therefore central blood volume variations (Chan et al., 2007b). Following central blood~     volume reductions induced by head-up tilting ventricular diastolic filling time increases~     involving an increase in PEP and PTT. Chan et al. (Chan et al., 2007b) concluded that PTT~     could have been used to assess early central hypovolemia and suggested that joint analysis~     of PTT and RR intervals could help in predicting the extent of blood volume loss. The~     investigators hypothesized that sympathetic drive associated with trauma would act on~     cardiac contractility through beta activity thus shortening PTT without reducing RR interval~     to the same extent in healthy hearts. We also hypothesized that progressive hypovolemia~     would lead to a rising of PTT (augmented diastolic filling time) and a RR interval~     shortening (relative tachycardia). In this study the investigators propose and index based~     on the beat-to-beat PTT/RR ratio to assess central hypovolemia in traumatic patients~     enrolled by our Helicopter Emergency Medical System (HEMS) in a prehospital setting.~   "
140911|NCT01210404|"~     Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C~     infection. Given the likelihood of co administration of filibuvir and methadone, this study~     will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.~   "
140912|NCT01210391|"~     The primary objective of the clinical trial is to compare growth in infants (expressed as~     weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants~     consuming a commercially available EHF.~   "
140913|NCT01210378|"~     Nitroglycerin is a nitric oxide donor which is mainly known as a vasodilating agent used in~     ischemic heart disease. It has also been shown to increase tumor blood flow in animal and~     human tumors.~      The addition of nitroglycerin to chemotherapy in non small cell lung cancer has been shown~     to generate very favorable response rates with respect to standard treatment schedules[5].~     Theoretically nitroglycerin might reduce resistance to chemotherapy via a plethora of~     different effects: better tumor perfusion, direct effects of NO on cancer cells, increase in~     activated p53 protein and via an increased blood flow in the tumour with as consequence a~     higher drug concentration in the tumor [6] .~      In mice, nitric oxide donors such as isosorbide dinitrate have been shown to decrease tumor~     hypoxia by better tumor perfusion, which could enhance radiotherapy responses [7].~      To date these combined effects have not been tested in humans. In this trial we would like~     to demonstrate the effect of nitroglycerin on tumor perfusion and hypoxia in non small cell~     lung cancer (using DCE and HX4 scanning), providing a rationale for further study and to~     test the effect of combining nitroglycerine to standard treatment of NSCLC~     (radiotherapy/chemotherapy).~   "
140914|NCT01210365|"~     The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40~     mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)~   "
140915|NCT01210352|"~     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of~     oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain~     in pediatric subjects.~   "
140916|NCT01210339|"~     The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic~     Acid (ASA) 81 mg affect the metabolism of clopidogrel.~   "
140917|NCT01210326|"~     Azoospermia , as the name suggests , refers to the condition in which there are no sperm in~     the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count~     have normal libido; normal sexual function; and their semen looks completely normal too. The~     diagnosis can only be made by examining the semen under a microscope in the laboratory.Men~     with non-obstructive azoospermia have a normal passageway, but abnormal testicular function,~     and their testes do not produce sperm normally. Some of these men may have small testes on~     clinical examination. The testicular failure may be partial, which means that only a few~     areas of the testes produce sperm, but this sperm production is not enough for it to be~     ejaculated. Other men may have complete testicular failure, which means there is no sperm~     production at all in the entire testes. The only way to differentiate between complete and~     partial testicular failure is by doing multiple testicular micro-biopsies to sample~     different areas of the testes and send them for pathological examination. This technique is~     called TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm~     extraction) or mTESE ( micro-testicular sperm extraction).~   "
140918|NCT01210313|"~     -  feasibility of physical activity~        -  increase of physical conversation~        -  Quality of Life (optional)~        -  vascular and metabolic effects~   "
140919|NCT01210300|"~     The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a~     higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is~     concerning, as repeat CS are associated with increased maternal morbidity and mortality, and~     neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such~     birth complications. However, there is limited information about Taiwanese women's decision~     regarding VBAC and their participation in decision-making. There is also a gap in literature~     about information for women about CS and VBAC.~   "
140920|NCT01210287|"~     The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in~     Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved~     hepatitis B undergoing RCHOP immuno-chemotherapy.~   "
140921|NCT01210274|"~     Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71~     years). IPSS classification defines low risk (Low and Intermediate 1), and high risk~     (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation~     into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has~     been mainly achieved through a rigorous empirical and clinical research, but the molecular~     mechanisms by which this molecule exerts its effects remain poorly characterized. The~     primary mode of action of Azacytidine is through DNA demethylation, and integration in to~     mRNA that favor traduction inhibition. The impact of this molecule on various cell death~     programs involved in the elimination of leukemic cells : apoptosis and autophagy is~     currently poorly known.~      The research program and clinical studies we proposed focus on two major aspects:~      - Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of~     apoptosis versus autophagy.~      - Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting~     apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively~     induce different types of cell death (apoptosis or autophagy).~   "
140924|NCT01210235|"~     The investigators overall goal is to develop, implement, test, and disseminate an~     intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by~     providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older~     who participate in annual influenza vaccination campaigns. The investigators hypothesis is~     that the FLU-FIT Program will be an effective method to increase colorectal cancer screening~     rates at Kaiser Permanente.~   "
140925|NCT01210222|"~     This phase II trial studies the side effects and how well trebananib works in treating~     patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of~     endometrial cancer by blocking blood flow to the tumor.~   "
140926|NCT01210209|"~     RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their~     relatives may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer.~      PURPOSE: This research study is looking at blood samples collected from patients with Ewing~     sarcoma and their relatives.~   "
140927|NCT01210196|"~     To detect early signs of cardiac and metabolic alterations as well as to evaluate the~     progression of cardiac and metabolic impairments in mildly affected patients with Fabry~     Disease using high sensitive diagnostic methods.~   "
140928|NCT01210183|"~     Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a~     particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage~     status will be monitored by pre and post treatment arthroscopy views with specialized~     (methylene blue) staining for cartilage.~   "
140929|NCT01210170|"~     Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation~     transporters expressed by non-neuronal cells, thereby interfering with the inactivation of~     the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations,~     and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor~     sites on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by~     the ICS' effect on the glucocorticosteroid-sensitive organic cation transporters. The~     investigators have shown in human airway vascular smooth muscle cells that the~     glucocorticosteroid action on organic cation uptake occurs within minutes, does not involve~     gene transcription or protein synthesis, is not mediated through classical steroid~     receptors, and is cell membrane-linked.~      In the present proposal, the investigators wish to use different single doses of mometasone,~     a clinically effective ICS, administered with or at different times before albuterol~     inhalation in subjects with moderate persistent asthma who are obstructed at the time of~     study.~      With this approach the investigators will test the hypothesis that a single inhalation of~     mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic~     bronchodilation.~      If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic~     bronchodilation is correct, the results would have a significant impact on treatment~     strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.~   "
140930|NCT01210157|"~     The purpose of this study is to determine whether galectin-3 binding protein plasma levels~     can predict adverse cardiovascular events in patients with coronary artery disease and/or~     heart failure.~   "
140931|NCT01210144|"~     This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine~     the gene expression profiles and histologic changes of the endometrial tissue before and~     after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic~     markers in assisted reproductive technologies (ART) in addition to the clinical predictive~     factors already known. Among those predictive factors, the state of the endometrium is~     considered as an important implantation determining factor for which pharmacogenomic~     research is of great interest.~      The direct benefits of this study will be to know whether the endometrial gene expression~     profile is modified in response to stimulation treatment and have an impact or not on the~     endometrial tissue receptivity. The potential benefits of this study could be to assess the~     therapy optimization based on individual treatment response and gene expression profile~     compared to group treatment response in infertile women and prediction of response to~     therapy based on gene expression profiling before and after Gonal-f® stimulation in~     infertile women.~   "
140932|NCT01210131|"~     Since radiation dose escalation to a large volume of tumour inevitably will induce higher~     toxicity than is currently the case, efforts must be made to limit the volume of tissue~     irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable~     tumour dose when keeping the normal tissue doses constant. Central is thus the question~     whether it would be possible to limit the volume of tumour to be boosted by selectively~     escalating the radiation dose to specific disease sites which are theoretically more prone~     to relapse.~   "
140933|NCT01210118|"~     The aim of this clinical trial is to test whether offering pregnant smokers a high intensity~     intervention for smoking cessation increases the rate of smoking cessation at the third~     trimester of pregnancy, compared to low intensity intervention for smoking cessation that is~     the usual care, control condition.~   "
140934|NCT01210105|"~     To determine whether video laryngioscopes facilitate intubation in ice-pick position in a~     manikin with restricted access to the airway~   "
140935|NCT01210092|"~     To determine whether different video laryngoscopes facilitate intubation in an manikin with~     immobilized cervical spine compared with standard laryngoscopy.~   "
140936|NCT01210079|"~     Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the~     ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced~     hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients.~     Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating~     neuropathic pain will be evaluated for its ability to ameliorate or diminish the~     opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and~     tolerance to both cold-pressor and electrical pain, at peak and through methadone blood~     levels. The results of this work will not only provide pharmacologic insight into the~     mechanisms underlying poor pain tolerance in this at-risk population, but also direction for~     the medical management of pain complicated by opioid-induced hyperalgesia.~   "
141240|NCT01206088|"~     The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with~     Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete~     cytogenetic response rate(CCyR) at 12 months after nilotinib administration.~   "
140937|NCT01210066|"~     Providing pain management to the patient who abuses prescription opioids presents a clinical~     challenge, not only due to concerns about drug-seeking, but because they have increased~     sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an~     effort to improve pain treatment, the aims of the proposed work are to evaluate the~     analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population,~     and to examine the role of opioid-induced proinflammatory changes in these responses.~   "
140938|NCT01210053|"~     RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether~     sunitinib is effective in treating non-small cell lung cancer.~      PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as~     maintenance therapy in treating patients with stage III or stage IV non-small cell lung~     cancer which is previously treated with combination chemotherapy.~   "
140939|NCT01210040|"~     A randomized double-blind controlled trial will be carried out in which young, nulliparous~     (having never given birth) women will be randomly assigned to receive weekly supplementation~     with either iron and folic acid or folic acid alone. Women will be followed-up weekly up to~     18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in~     both groups will be compared by assessing the prevalence of peripheral parasitaemia at the~     first antenatal clinic visit for pregnant women and at the end of the first malaria~     transmission season for non-pregnant women. The incidence of clinical malaria will be~     assessed by active and passive case detection throughout the follow-up period.~   "
140940|NCT01210027|"~     Researchers at the the University of Michigan are conducting a research project to assess~     how a course of radiation therapy changes the way blood flows through the liver. To be able~     to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed~     before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each~     occasion, you will be injected with a fluid called gadolinium (a contrast agent) before~     getting an MRI. This contrast agent makes it easier for the Researchers to see your organs~     in the scans, and causes any abnormal areas to become very bright on the MRI. This agent~     will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45~     minutes.~   "
140941|NCT01210014|"~     Recurrent aphthous stomatitis (RAS) is one of the most common of oral mucosa diseases that~     affects approximately 20% of the general population. Despite the fact that clinical,~     pathologic and therapeutic feature of the disease has been comprehensively studied, the~     pathophysiology of aphthous ulcers remains incompletely understood.~      Zinc is a potent catalyst of wound healing and zinc deficiency may be a common cause of~     delayed tissue repair. Use of zinc sulfate in promotion wound healing and preservation of~     epithelial integrity advocated its possible use in the treatment or prevention of recurrent~     oral ulcers.~      The purpose of the present study was to determine of systemic zinc sulphate in the treatment~     of recurrent aphthous stomatitis.~   "
140942|NCT01210001|"~     This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients~     in order to provide these data for approval for BI 10773 by regulatory authorities as an~     antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.~   "
140943|NCT01209988|"~     To date, there is a lack of consensus concerning the optimal timing for removal of the~     urethral catheter, its related complications, the effectiveness in prophylactic drug use to~     reduce complication, and the patient reported outcomes (quality of life) after~     robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine~     the impact of tamsulosin on voiding patterns following early urethral catheter removal after~     RALP for prostate cancer.~   "
140944|NCT01209975|"~     The purpose of this study is to assess retinal blood flow and vascular reactivity in~     patients with newly diagnosed primary open angle glaucoma pre- and post-primary Selective~     Laser Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of~     retinal blood flow.~   "
140945|NCT01209962|"~     Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy~     and chemotherapy, depending on the location of the cancer and other individual patient~     health factors. The goals of therapy are to reduce or eliminate the cancer cells, but~     without serious damage to normal cells. Investigators at The University of Michigan are~     conducting a research project, to see if treatment effects on an individual patient's cancer~     cells can be detected early by new imaging tests in patients with resectable pancreatic~     cancer undergoing neoadjuvant chemoradiotherapy.~   "
140946|NCT01209949|"~     The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to~     treat mild to moderate acne vulgaris using efficacy measurements, quality of life~     instruments, and video diaries.~   "
140947|NCT01209936|"~     This was a pilot study to validate the BC3 hydration factor which will be important for~     determining how well this value represents hydration status compared to assessment of total~     body water by D20.~   "
140948|NCT01209923|"~     The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance~     analyzer to assess percent body fat in children and adults. The BC1 was compared to~     dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic~     weighing assessment of body fat for children. We hypothesized that the BC1 would provide~     similar measures of body fat between devices with acceptable limits of agreement.~   "
140960|NCT01209767|"~     This study intended to investigate and compare the changes that may occur in response to~     cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The~     cryolipolysis cooling device used is FDA approved for skin cooling, but still~     investigational in the treatment of cellulite. It has previously been used for fat reduction~     on love handles or back fat. During cryolipolysis, the system drew fat tissue into an~     applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure~     caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision~     is a process used to treat scars left behind by acne or other skin diseases and has been~     noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that~     is performed by inserting a specially designed needle under the skin after local numbing~     medication is injected. The needle is moved in a repetitive motion parallel to the skin to~     separate the surface tissue from the deeper scar tissue with the goal to improve the~     dimpling caused by these tissues sticking together. This study was a pilot study designed to~     determine feasibility of these procedures.~   "
140949|NCT01209910|"~     Inpatients in the neurology rehabilitation units at Riverview Health Center― people who are~     brain-injured and or who have had a stroke ― often have dysphagia as a result of their~     condition. They are considered at high risk of aspiration, which can result in pneumonia. To~     limit that risk, these patients are only allowed to consume thickened liquids at the~     beginning of their rehabilitation. They are restricted from consuming thin liquids, which~     means they can't even drink water. Depending on the rate of their rehabilitation, these~     restrictions can last from six months to a year.~      Patients on a diet of thickened liquids sometimes have difficulty consuming the required~     daily intake of fluids and they become dehydrated, which in turn can lead to other health~     complications. As well, thickened liquids do not always satisfy a patient's thirst, says~     Pooyania.~      While Riverview does not allow inpatients with dyspagia to have water at the beginning of~     their rehabilitation, many rehab facilities in Canada and the U.S. follow the Frazier Free~     Water Protocol, which does allow patients unrestricted water intake prior to and 30 minutes~     after meals. The belief that this protocol is safe is based on research done at the Frazier~     Rehabilitation Institute, where a study demonstrated no difference in rates of aspiration~     pneumonia between an experimental group on a free water protocol and a control group.~      The Frazer study was only one randomized controlled trial with a very limited number of~     patients. There have been a few case reports as well, but at Riverview centre, the protocol~     is not accepted because the investigators don't believe there is enough evidence behind it.~     The investigators intend to provide more clinical evidence so that both the risks and~     benefits of a free water protocol can be assessed.~      The investigators will be screening patients admitted to the neurology rehabilitation units~     at RCH, including both the stroke and acquired brain injury programs. The investigators~     expect to find at least 30 suitable candidates.~      Participants will be educated about dysphagia and the free water protocol, and the treatment~     group will be allowed unrestricted water intake prior to and 30 minutes after meals.~     Individualized intervention to minimize aspiration will be provided. Daily and weekly~     monitoring and testing of all patients will take place. The pilot study will continue for 11~     months. A secondary objective of the research is to determine the feasibility of expanding~     into a multi-centre clinical trial~   "
140950|NCT01209897|"~     The topic of this research is cigarette smoking cessation. We designed four smoking~     cessation booklets. These booklets are designed for smokers who differ in their motivation~     to quit smoking. We will compare different ways of matching booklets to smokers who vary in~     their motivation to quit smoking.~   "
140951|NCT01209884|"~     This research is being done to learn more about healthy aging. We hope to learn which bodily~     processes or functions are important for the elderly to maintain good health. Metabolites~     (for example, glucose) are small molecules in our bodies that are used in all bodily~     reactions. Looking at their levels in healthy elderly people may help researchers find out~     which processes lead some people to get to disease and others to not.~      Metabolites are the basic building blocks for people. They are used to construct larger~     complexes(such as proteins), relay signals from one part of the body to another, and as a~     source of energy.~      While most people have essentially the same types of metabolites, the relative levels of~     these metabolites vary from one individual to another. These levels reflect the body's state~     of growth, development, and reproduction. An appropriate balance in metabolites is important~     to maintaining general health. Conditions like cancer and diabetes result in disrupted~     levels of metabolites that are associated with changes in bodily functions. Deviations from~     normal levels of metabolites can be used as a signature for disease. Researchers have~     discovered that a disruption in unique metabolite levels is associated with human aging. In~     this study we hope to learn which, if any, of these disruptions are associated with the~     onset of age-related disease.~   "
140952|NCT01209871|"~     The goal of this clinical research study is to find the highest tolerable dose of a cancer~     vaccine that can be given to patients with asymptomatic lymphoplasmacytic lymphoma (LPL).~     The safety of this vaccine is also being studied.~   "
140953|NCT01209858|"~     The purpose of this study is to investigate the effects of perampanel on the~     pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol~     (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated~     dosing of OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.~   "
140954|NCT01209845|"~     The investigators hope to see if a commonly used drug such as ketamine could help depressed~     ER patients feel better and improve their mood quickly.~   "
140955|NCT01209832|"~     The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using~     midazolam as a sensitive and specific probe substrate of CYP3A.~      The study will also assess the safety and tolerability of tasisulam and midazolam given in~     combination and document any antitumor activity with tasisulam.~   "
140956|NCT01209819|"~     Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the~     enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause~     mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems.~     Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the~     developmental and behavioral problems.~      The foundation of this diet is a phe-free medical product/formula made from free amino~     acids. Based on longitudinal studies, it has been reported that the most benefit is attained~     by individuals who maintain a phe-restricted diet throughout life. Despite the obvious~     benefits of the diet, it has been suggested that the dietary restrictions may be associated~     with poor bone health in these patients. However, data supporting this has been reported in~     studies with small sample sizes and/or inadequate sample populations that include children.~     There is a paucity of data on bone health in adults with HPA.~      The investigators propose an observational study to describe the bone health status among~     adults with a diagnosis of HPA and to compare them to established normative age and~     gender-specific values among healthy individuals. The investigators hypothesize that adults~     with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan~     compared to the established normative values.~   "
140957|NCT01209806|"~     The purpose of this study is to determine whether the administration of PEG along with~     simethicone will reduce the incidence of colonic bubbles that interfere with polyp~     detection.~   "
140958|NCT01209793|"~     This study is being conducted to assess the safety and tolerability of a single ascending~     intravenous (IV) dose of REGN846 in healthy volunteers.~   "
140959|NCT01209780|"~     This study will evaluate the safety and immunogenicity in healthy children and adolescents~     after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.~   "
140961|NCT01209754|"~     The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of~     Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective~     observational cohort investigation of exposures to study agents under investigation for HIV~     prevention. The study population will consist of female participants who are identified as~     becoming pregnant during their participation in a microbicide or PrEP trial, or who have had~     planned exposures in pregnancy safety studies as well as their babies resulting from these~     pregnancies. This study will only enroll babies who have not yet reached their 1 year birth~     date.~   "
140962|NCT01209741|"~     This study will evaluate the comparative bioavailability of three capsule formulations of~     MK-0974.~   "
140963|NCT01209728|"~     This is a double-blind, parallel design study in elderly primary insomnia patients and~     demographically matched controls. The objectives if this study are primarily: 1. To~     determine if functional deficits in simulated driving performance can be demonstrated in~     primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and~     secondarily: 2. To compare simulated driving performance deficits in elderly primary~     insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least~     one of the following driving endpoints: standard deviation of lane position (SDLP), standard~     deviation of speed (speed deviation), lane excursions, and a driving composite score.~   "
140964|NCT01209715|"~     In the present study, the investigators wish to address the effect of a~     glucocorticoid/long-acting beta-agonist preparation on endothelial function in COPD patients~     who do not currently smoke (ex-smokers) by measuring endothelium-dependent (albuterol~     response) and endothelium-independent (NTG response) vasodilation in the bronchial artery,~     reflecting endothelium-dependent and endothelium-independent vasodilation (drug-induced~     increase in Qaw, ΔQaw). With this approach the investigators will test the hypothesis that~     in stable ICS-naïve COPD patients, endothelium-dependent vasodilation is restored with a~     glucocorticoid/long-acting beta-agonist preparation, presumably resulting from the~     glucocorticoid component.~   "
140965|NCT01209702|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and~     efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who~     have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor~     necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized~     to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for~     12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4~     mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be~     followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week~     208 for all patients. Anticipated time on study treatment is 208 weeks.~   "
140966|NCT01209689|"~     This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of~     tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an~     inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients~     were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously~     (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed~     by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all~     patients.~      This study and all further clinical development of tocilizumab AS was halted after a review~     of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in~     TNF antagonist naïve AS patients, failed to demonstrate efficacy.~   "
140967|NCT01209676|"~     A phase 0, exploratory study of the pharmacodynamics of a single intratumoral dose of~     IMCgp100, a monoclonal T cell receptor anti-CD3 scFv fusion protein, in subjects with~     advanced unresectable melanoma to assess the safety and pharmacodynamic properties of single~     intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Six~     patients will be enrolled to complete the study over approximately 12-15 months.~   "
140968|NCT01209663|"~     The objective of this trial is to evaluate postoperative intermediate care versus ward care~     in patients who have undergone emergency abdominal surgery with a perioperative Acute~     Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients).~      Patients will be enrolled in the trial, if they are ready to be discharged from the recovery~     unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery.~     Discharge criteria will be according to the Danish national recommendation.~      The intermediate care bed in the trial is defined by a certain minimum requirements to~     patient observation and described treatment possibilities which have to be available to the~     intermediate bed. If the treatment exceeds these treatment possibilities, the patient will~     be classified as an intensive care patient. The intermediate care bed will be placed at an~     intensive care unit, recovery unit or a surgical high dependency unit. If there is no~     available intermediate care bed, the patients will not be randomized, but only registered as~     excluded because of no available intermediate care bed.~      Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day~     mortality in emergency abdominal surgery patients with a high risk of postoperative organ~     failure.~      Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted~     the interim analysis based on the analysis of the primary outcome blinded for intervention~     allocation. The DMSC will use P<0.001 (Haybittle-Peto) on two subsequent interim analyses as~     the statistical limit to guide its recommendations regarding early termination of the trial~     for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up~     data of about 50% (i.e., about 200 patients) of the trial participants have been obtained~     and/or 75 deaths have been documented during the trial. If P<0,001 in the first interim~     analysis a second interim analysis will be conducted when the 30 days follow-up data of~     about 75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25~     deaths have been documented during the trial.~      Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low~     overall event rate of the primary outcome at the first interim-analysis as compared to the~     pre-trial estimated. This precluding any possibility to detect or reject the anticipated~     relative risk reduction of 34 % as used in the sample size estimation.~   "
140969|NCT01209650|"~     The program will provide early access to the investigational drug BIBW 2992 to treat~     patients with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.~      The Compassionate Use Programme will also provide additional safety and efficacy information~     on BIBW 2992 use.~      Named Patient Use (NPU)~   "
140970|NCT01209637|"~     Exercise training in patients with coronary artery disease is able to correct several risk~     factors. Furthermore endothelial function can be improved.~      There are some hinds for improved collateral circulation after exercise training,~     nevertheless there is no study showing significant improvement/ increase in coronary~     collaterals. This might be due to technique of collateral measurement. Therefore we conduct~     a study were coronary blod flow before and after 4 weeks of exercise training were measured.~   "
140971|NCT01209624|"~     The purpose of this study is to assess the long-term efficacy and safety of latanoprost~     monotherapy in patients with normal tension glaucoma (NTG) using a prospective,~     observational design. Visits were scheduled at 6-month intervals for 24 months. Intraocular~     pressure (IOP), optic nerve head findings, visual field status, and adverse events were~     recorded.~   "
140972|NCT01209611|"~     The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells~     transplantation is safe and/or effective to accelerating skin regeneration and soft tissue~     expansion.~   "
140973|NCT01209598|"~     The purpose of this study is to find out what effects, good and/or bad, Palbociclib~     (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.~      Palbociclib is an investigational drug. An investigational drug is a medication that has not~     been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a~     protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The~     investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells~     and stop tumors from growing. Palbociclib is an oral medication.~   "
140974|NCT01209585|"~     The purpose of this study is to study the evaluation of blood samples and blood types to~     identify functional protein in the joints.~   "
140975|NCT01209572|"~     At this time, 24h energy expenditure is rarely assessed under free-living conditions for~     specific individuals because of the lack of cheap and accurate software/materials to record~     the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor,~     Actiheart, SenseWear Armband) are available on the market but the predictive equations~     comprised into the software provided with these tools generally miscalculate the energy~     expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor~     knowledge of the modification of the energy expended during daily life activities and over~     24h in subjects belonging to groups of various ages and physiological states. The~     investigators hypothesise that it could be possible to improve the energy expenditure~     prediction.~      The project aims at providing a mathematical model (equations) that predicts energy~     expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight~     volunteers aged between 18-60 years participate to this study. The first group stay for 26h~     in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry,~     and other parameters are recorded during various activities. These data will serve to~     construct the model. The same type of recordings are performed on second group of volunteers~     in free living conditions. Their energy expenditure is measured overall by doubly labeled~     water. The data of the second group will serve to validate the model. The error percentage~     of the model is defined by the ratio of the value of the difference between prediction and~     reference measure to the reference measure. Concordance between predictions and measures~     will be evaluated by Bland - Altman plots.~   "
140976|NCT01209559|"~     The objective of this study is to determine if the glottic view obtained with the air-Q~     Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA)~     is better than that obtained with the traditionally used intubating laryngeal mask airway~     (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare~     effectiveness of ventilation.~   "
140977|NCT01209546|"~     The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.~   "
140978|NCT01209533|"~     The purpose of the study is to determine if inhaled iloprost given four times daily can~     improve symptoms and lung function in adults with mild asthma.~   "
140979|NCT01209520|"~     The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer~     (NSCLC) driven by epigenetic changes. The investigators study the impact of 5-azacitidine~     (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy~     in a sequential fashion. The study population consists of all NSCLC patients who undergo~     curative lung cancer resection and whose tumors harbor hypermethylation in any of the~     protocol-specific genes (samples will be banked for additional molecular testing including~     other 21 loci which have shown to be important in lung carcinogenesis.~   "
140980|NCT01209507|"~     Gynecologic Oncology patients have several different chemotherapy regimens, and~     dexamethasone is now routinely given to prevent allergic reactions to the chemotherapeutic~     agents. The most common chemotherapeutic agents used are paclitaxel and carboplatin. This~     combination regimen is given every three weeks for a total of 5-6 doses. Each dose is given~     after administration of 20 mg dexamethasone twelve hours prior to and the morning of~     chemotherapy. Dexamethasone is used for its antiemetic effects, but also to minimize the~     potentially fatal hypersensitivity reaction that can occur with paclitaxel. Another commonly~     used chemotherapy regimens is weekly cisplatin given with one dose of dexamethasone for~     cervical cancer. Chronic steroids are known to cause adrenal suppression, but it is not~     known if the amount of dexamethasone given with the gynecologic cancer chemotherapy regimens~     described above causes adrenal insufficiency in these patients. The investigators hypothesis~     is that some women receiving steroids with their chemotherapy may have adrenal~     insufficiency, and that they will have greater than normal chemotherapy-related fatigue.~   "
140981|NCT01209494|"~     The prospective EUTrigTreat multi-center study is an observational, advanced diagnostics and~     genetic risk stratification trial in patients with standard indications for ICD treatment,~     with and without myocardial infarction in their history.~      Its aims are fourfold: 1) To accurately risk stratify a large cohort of implantable~     cardioverter-defibrillator (ICD) patients for ICD shock risk and mortality using traditional~     risk markers as well as genetic markers 2) To find a link between repolarization biomarkers~     and genetic markers of calcium metabolism. 3) To compare invasive and noninvasive~     electrophysiologic (EP) testing systematically 4) To assess temporal changes of typical~     noninvasive risk stratifiers and their prognostic implication.~      In five European academic clinical centers, 700 ICD patients are prospectively enrolled~     (optionally the number of enrolled patients may be expanded to 1000 patients). Comprehensive~     non-invasive risk stratifying ECG diagnostics including beat-to-beat variability of~     repolarization (BVR) are applied, and candidate genes associated with malignant arrhythmias~     are analyzed. Programmed electrical stimulation is performed to test for inducibility of~     malignant ventricular arrhythmias and BVR. In a subset of patients, electrophysiologic~     studies include recording of monophasic action potentials (MAP) from the right ventricle for~     assessment of restitution properties. Non-invasive risk stratifying ECG methods are repeated~     annually. Outcome (mortality, ICD shocks) will be assessed until September 2014.~   "
141002|NCT01209221|"~     This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate~     the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses~     of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either~     a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of~     RO5271983 or placebo in the MAD part. The anticipated time on study treatment is~     approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.~   "
141003|NCT01209208|"~     The purpose of this study is to determine whether budesonide or mesalazine is more active in~     the treatment of lymphocytic colitis.~   "
141004|NCT01209195|"~     This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in~     combination with paclitaxel using a 3+3 design.~   "
141005|NCT01209169|"~     The purpose of this study is to collect blood and urine samples that may help identify and~     validate biomarkers for the early detection and risk assessment of acute kidney injury~     (AKI).~   "
141006|NCT01209156|"~     The underlying goal of this study is to assess PBR-111 positron emission tomography (PET)~     imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD)~     research participants and age- and gender-matched healthy volunteers.~   "
140982|NCT01209481|"~     The right to food and nutrition is established in the Universal Declaration of Human Rights~     as they are basic requirements for promoting and protecting good health. They can also be~     instruments to evaluate the quality of life of human beings and communities. Awareness of a~     healthy diet is the first step in behavioral change, and nutritional education can be an~     instrument for avoiding diseases resulting from both intake deficit and excess. Educational~     group actions can change food intake. This study will aim at evaluating, planning and~     implementing the impact of a nutritional education group action concerning the consumption~     of fruit and vegetables in adult and elderly individuals attended to by a Primary Health~     Care (PHCU) Unit. It will be a randomized assay involving two groups comprising male and~     females individuals distributed in the following fashion: Intervention Group, in which the~     educational group action (EGA) will be performed in addition to routine activities; and~     Control Group, the individuals from which will only participate in the routine activities in~     the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40~     in each group. In order to determine the consumption of fruit and vegetables, a weekday and~     a Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term~     effects) months after completing the intervention. The educational group activities will~     consist of two-hour group dynamics and cooking workshops once a week and for five weeks.~     Serum carotenoid dosages will also be performed in the two groups by sub-sampling (n=40)~     with the purpose to validate the estimated intake of fruit and vegetables obtained from the~     recalls.~   "
140983|NCT01209468|"~     Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five~     men and one in fifty women over the age of 30. This breathing abnormality occurs during~     sleep and is characterised by snoring and episodes of sleep disturbances. The symptoms of~     untreated OSA (e.g. excessive daytime sleepiness), can result in significant reductions in~     the patients' quality of life. The key treatment modalities today include Continuous~     Positive Air Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly,~     OAs have been advocated in the treatment of the symptoms of OSA since they offer a~     non-invasive form of treatment and also because patients often prefer this treatment to~     other treatment modalities. There is increasing evidence to support the effectiveness of OAs~     in the management of OSA, at least as a short term measure. What is still unclear is which~     types of OA are most effective and whether OAs are effective in the long term management of~     OSA. This randomized clinical trial aims to evaluate two differently designed OAs in terms~     of their effect on patients' quality of life and on the physiological symptoms of OSA~     (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of~     patients referred to the dental hospital for treatment from the medical faculty. The~     treatment with OAs will commence after randomization to two treatment groups; follow-up~     examinations will take place over a period of 12 months. The results of this study will help~     inform practitioners and patients of the feasibility of using OAs in the long term~     management of OSA and help determine the most appropriate type of OAs for the management of~     OSA and improvement in quality of life.~   "
140984|NCT01209455|"~     Paracetamol overdose is the leading cause of acute liver failure in the Western World.~     N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is~     associated with adverse effects in 40% of cases. Patients characteristically experience~     nausea, vomiting and an anaphylactoid ('pseudo-allergic') syndrome. This reaction is~     clinically similar to true anaphylaxis (allergic reaction) including flushing, rash,~     constriction of airways, and a fall in blood pressure, but occurs via a different mechanism.~     Although treatable, these reactions lead to patient distress, commonly cause confusion among~     treating physicians, and lead to significant delays in antidote administration. The~     aetiology of these adverse reactions to NAC remains unclear. We hypothesise: i) these~     reactions result from a dose-dependent release of the chemical histamine, causing dilatation~     of blood vessels (vasodilatation) and the anaphylactoid syndrome; ii) paracetamol conversely~     exerts a protective effect on the reaction, with a less severe reaction observed in the~     presence of higher paracetamol concentrations. We will investigate the mechanisms underlying~     adverse reactions to NAC in the human forearm model, examining the role of histamine and~     other markers involved in the inflammatory process. The wider significance is an improved~     understanding of this poorly delineated phenomenon, with implications for other medications~     associated with similar reactions, such as non-steroidal anti-inflammatory drugs and opioids~     such as morphine.~   "
140985|NCT01209442|"~     The purpose of this study is to find out whether Hypofractionated Intensity-Modulated~     Radiation Therapy (Hypo-IMRT) combining with temozolomide chemotherapy can be safely given~     with a targeted agent, bevacizumab, and how effective this study treatment will be in~     controlling your brain tumor.~   "
140986|NCT01209429|"~     This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by~     that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men~     on calorie restriction on 4 study days with fat and skeletal muscle biopsies.~   "
140987|NCT01209416|"~     This study will investigate the non-growth-hormone-dependent metabolic effects of the~     hormone Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as~     well as signal proteins in fat and muscle biopsies.~   "
140988|NCT01209403|"~     The purpose of this study is to investigate whether the anabolic potentials of insulin may~     be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with~     end-stage renal failure.~   "
140989|NCT01209390|"~     The objective of this post-marketing study is to confirm the clinical efficacy and safety~     outcome of treatment with ChondroMimetic in a patient population within the proposed~     indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up~     period.~      The primary objective is to collect post-marketing safety data in a real life setting by~     means of (S)ADR reporting.~      The secondary objectives are:~        -  Clinical outcome as assessed by patient reported EuroQoL-5D~        -  Structural repair as assessed by MRI~        -  The number of treatment failures and the time to treatment failure~        -  The ease of use of ChondroMimetic as reported by the surgeon~   "
141007|NCT01209143|"~     This is a single-arm, multicenter, Phase Ib study designed to describe the effect of~     GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with~     advanced solid tumors who are refractory to treatment or for whom no standard therapy~     exists.~   "
140990|NCT01209377|"~     EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the~     treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of~     EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation~     triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining~     the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation~     reaction, and the duality of alertness focus during trauma exposition causes a distraction~     of the traumatic topic.~      Within a randomized controlled study 120 patients will be treated during 8 therapeutical~     sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without~     bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual~     stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD~     symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after~     treatment (max 8 sessions of psychotherapy).~      The following hypothesis are investigated in the study:~        1. EMDR treatment with bilateral stimulation through eye movements will be followed~          significant larger reduction in CAPS compared with EMDR treatment without bilateral~          stimulation (specific treatment effect of eye movements)~        2. EMDR with eyes fixed will be followed by a significant larger reduction in CAPS~          compared with EMDR without external focus (specific treatment effect of distraction)~   "
140991|NCT01209364|"~     The primary objective is to determine whether Durolane is non-inferior to~     methylprednisolone, as assessed by level of pain, when each are given as single~     intra-articular injections for the relief of pain, in the treatment of symptomatic~     osteoarthritis of the knee at 12 weeks.~   "
140992|NCT01209351|"~     The primary objective of this study is to assess the effects of 10 consecutive, daily,~     subcutaneous doses of 4 mg of teduglutide as compared with placebo on gastric emptying as~     assessed by acetaminophen absorption kinetics in healthy subjects.~   "
140993|NCT01209338|"~     The overall program goal is to determine the Acceptability and Feasibility of introducing a~     population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key~     individual and community factors that would determine the potential acceptability of the~     vaccine.~   "
140994|NCT01209325|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to prevent viral infection.~      PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human~     papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.~   "
140995|NCT01209312|"~     The investigators are hoping to figure out how youth with type 1 diabetes can best control~     their blood glucose levels after meals, by determining whether accurate carbohydrate dosing~     or the timing of the bolus is more important. There is evidence to suggest that each~     strategy is important for blood glucose control. Unfortunately, for some people, prebolusing~     is difficult, because they may not know how much they are going to eat. To give an exact~     dose of insulin 20 minutes before a meal can be difficult. In this study, the investigators~     would like to show that taking even just part of the insulin bolus 20 minutes before the~     meal is preferable to waiting until mealtime and taking the entire bolus. To do this, the~     investigators will have 24 patients in the study, who will each spend 4 mornings at The~     investigators clinic. The order of the visits will be selected randomly. The visits will~     include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking~     ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the~     person will eat the same meal, but the timing and amount of the bolus will be different. The~     investigators will measure the blood glucose levels with a blood glucose meter, and also~     with a laboratory test called YSI. The investigators will also be measuring the glucose~     levels under the person's skin with a continuous glucose monitor. The investigators will~     compare the area under the curve for the different visits, as well as the glucose levels at~     different points after the meal.~   "
140996|NCT01209299|"~     RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin~     and paclitaxel with or without sorafenib tosylate may help doctors learn more about the~     effects of this treatment on cells. It may also help doctors understand how well patients~     respond to treatment.~      PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy~     in patients with advanced or metastatic melanoma previously treated with carboplatin and~     paclitaxel with or without sorafenib tosylate.~   "
140997|NCT01209286|"~     The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab~     is effective, safe and tolerable in the treatment of patients with relapsed/refractory~     B-precursor ALL.~   "
140998|NCT01209273|"~     The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal~     Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).~   "
140999|NCT01209260|"~     This is a randomized controlled trial examining whether a mechanical needle versus a needle~     that uses radiofrequency energy is better at puncturing through a thin wall in the heart~     (called transseptal puncture) as measured by procedure time, during an electrical~     procedure/study of the heart .~   "
141000|NCT01209247|"~     The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The~     commensal flora is the main reservoir for antibiotic resistance. Understanding the factors~     (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of~     resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may~     help prevent it and preserve the efficiency of these important antibiotics. Samples of~     rectal, nasal and pharyngeal flora will be collected from hospitalized patients before~     receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical~     data will be collected. The incidence and risk-factors associated with the emergence of~     resistance to FQ will be assessed by comparing groups with and without resistance both at~     the end of treatment and 1 month later.~   "
141001|NCT01209234|"~     This randomized controlled trial will compare strategies to reduce the risk of~     methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA~     carriers. This trial will provide critical answers about the role of decolonization versus~     standard-of-care education in preventing MRSA infections in the large group of high risk~     MRSA-positive patients being discharged from hospitals. Findings could potentially impact~     best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each~     year.~   "
141009|NCT01209117|"~     This is a single-center, randomized, two part, open-label, crossover study in healthy adult~     subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet~     formulations manufactured by three different processes relative to the GSK2248761 WBM~     capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of~     the selected WBM tablet formulation (Part B).~   "
141010|NCT01209104|"~     GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that~     is being developed as a once-daily oral anti-inflammatory medication for the treatment of~     chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction~     between CXCR2 and its various chemokine ligands is a potential strategy for reducing the~     underlying inflammation in COPD via the inhibition of neutrophil recruitment and activation.~     The current study explores the effects of age, gender and food (high fat meal) on the~     pharmacokinetics of GSK1325756.~      Because a significant proportion of COPD subjects are prescribed proton pump inhibitors~     (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux~     disease (GERD), it is important to understand the absorption of the current formulation of~     GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients~     taking PPI's. Therefore, this study will also evaluate the impact of the proton pump~     inhibitor omeprazole on the pharmacokinetics of GSK1325756.~   "
141011|NCT01209091|"~     Introduction: Many reimbursement authorities use economic evaluation to help guide decisions~     regarding the adoption of new treatments in reimbursement systems. Survival and quality of~     life are often the main measure of benefit used in an economic evaluation - expressed as a~     quality adjusted life year (QALY). In addition though, some decision makers will also~     consider the impact of a treatment on a patient's ability to continue working (expressed in~     terms of productivity). The aim of the present study is to estimate quality of life weights~     (utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal~     Growth Factor Receptor 2 positive or HER 2+).~      Methods: Separate surveys will be used to assess utilities and productivity in HER2+~     metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes~     describing progressive disease, stable disease, and seven grade 3/4 adverse events~     (diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection~     fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on~     a literature review and in depth interviews with women with MBC in the Netherlands and~     Sweden. Clinical experts in both countries will review the health states for content~     validity. The health states will be translated using forward and back translation. Members~     of the general public will rate the states (100 men and women in NL; 100 women aged 50+ in~     Sweden) using the visual analogue scale and Time Trade Off method to determine utility~     values. In a separate survey women who are currently being treated or have recently~     completed their treatment for MBC will be surveyed regarding the impact of disease on their~     ability to work using a validated work productivity measure (Work Productivity and Activity~     Impairment) in women in the Netherlands and Sweden.~   "
141012|NCT01209078|"~     This study will determine the safety, tolerability and efficacy of GSK1322322 verses~     Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).~   "
141013|NCT01209065|"~     GSK1349572 is an integrase inhibitor being developed for the treatment of human~     immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV~     HealthcareLLC. In HIV-infected patients where combination antiretroviral therapy is the~     standard of care, it is likely that it will be dosed with boosted protease inhibitors (PIs)~     including fosamprenavir/ritonavir (FPV/RTV or FPV/r). As FPV and RTV are modulators~     (induction as well as inhibition) of Uridine diphosphate glucuronosyltransferase (UGT) and~     Cytochrome P450 (CYP)3A which are the primary and secondary metabolic pathways of~     GKS1349572, it is likely that FPV/RTV will affect the pharmacokinetics (PK) of GSK1349572,~     therefore a drug interaction study is warranted and will be evaluated in Part A of this~     study. Part B will evaluate the effect of particle size of tablet variants on the PK of~     GSK1349572.~      In Part A, approximately 12 subjects will receive GSK1349572 50mg every 24 hours (q24h) for~     5 days (Treatment A). Subjects will then be administered GSK1349572 50mg q24h in combination~     with FPV/RTV 700/100 mg every 12 hours (q12h) (Treatment B) for 10 days. There will be no~     washout between treatments. In Part B 15 subjects will receive a single 50 mg dose (2 x 25mg~     tablet) in 3 different tablet variants of the same formulation, differing only in particle~     sizes of GSK1349572, under fasted conditions in a three-way crossover design. Safety~     evaluations and serial PK samples will be collected during each treatment period. A~     follow-up visit will occur 7-14 days after the last dose of study drug.~   "
141014|NCT01209052|"~     This study aims to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single, oral ascending doses, and repeat oral doses of GSK1325756~     administered to healthy adult male volunteers. This study is the First Time in Human study~     for GSK1325756.~   "
141015|NCT01209039|"~     This study described in the present protocol consists of two parts. Part A is a multiple~     ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ascending~     doses of GSK1144814. Part B is an open label design in healthy male subjects to assess the~     GSK1144814 Neurokinin1 receptor occupancy.~   "
141016|NCT01209026|"~     A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose~     FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in~     healthy male and female subjects. Key assessments will include 12- lead electrocardiogram~     (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood~     pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.~   "
141017|NCT01209013|"~     Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a~     non heated laser. The activation of the drug is done by lighting of abnormal areas using a~     fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that~     permits transmission of light. The fiber optic device is inserted into a diffusing balloon~     device to ensure the good positioning of the fiber optic within the esophagus (food pipe).~     It is thought that the size and the flexibility of a new diffusing balloon device could~     improve the safety profile of the photodynamic treatment by reducing the risk of narrowing~     or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment.~      This research study will evaluate the safety and effectiveness of PDT with porfimer sodium~     using a new diffusing balloon device for light application in the removal of high-grade~     dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE).~     This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn)~     and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD~     in BE across North America and Europe and will last between 13 and 16 weeks. In addition,~     concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of~     patients.~   "
141018|NCT01209000|"~     Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous~     nephropathy (MN), generate an enormous individual and societal financial burden, accounting~     for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual~     cost in the US of more than $3 billion. However, the clinical classification of these~     diseases is widely believed to be inadequate by the scientific community. Given the poor~     understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies~     are imperfect. The therapies lack a clear biological basis, and as many families have~     experienced, they are often not beneficial, and in fact may be significantly toxic. Given~     these observations, it is essential that research be conducted that address these serious~     obstacles to effectively caring for patients.~      In response to a request for applications by the National Institutes of Health, Office of~     Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a~     number of affiliated universities joined together with The NephCure Foundation the NIDDK,~     the ORDR, and the University of Michigan in collaboration towards the establishment of a~     Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.~      Through this consortium the investigators hope to understand the fundamental biology of~     these rare diseases and aim to bank long-term observational data and corresponding~     biological specimens for researchers to access and further enrich.~   "
141019|NCT01208987|"~     The investigators plan to develop a process to create an Enhanced Medication List. The INPC~     (Indiana Network for Patient Care) already obtains histories of medications dispensed by~     pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies,~     Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the~     medication data available through the INPC for an individual patient. The investigators will~     enhance this medication list by including medication categories, improving the structure and~     appearance, displaying results of relevant laboratory tests, and adding decision support~     reminders. The investigators will test the value of such an Enhanced Medication List by~     providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging~     service, or as a fax), preferably on the day that the patient has an office visit with the~     physician. The investigators will determine whether this intervention improves patient care:~     whether there are higher rates of recommended laboratory follow-up monitoring as a result;~     whether there are lower rates of harmful drug-drug interactions. The investigators will also~     seek the opinions of physicians regarding the benefit of this intervention.~   "
141020|NCT01208974|"~     Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and~     immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer~     will allow better cosmesis and patient's satisfaction.~      Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic~     NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in~     patients with ductal carcinoma in-situ or invasive breast cancer.~      Primary objective: To determine the recommended phase I dose of post-operative prophylactic~     NAC irradiation.~      Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery~     with reconstruction, including both surgeon experience and patient evaluation of cosmetic~     results. Survival and recurrence will be assessed.~      Study size: Between 12 and 18 patients will be enrolled in this phase I study.~   "
141021|NCT01208961|"~     The objectives of this study are to compare the relative bioavailabilities of~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of~     Epanova or Lovaza during periods of high- and low -fat consumption.~   "
141022|NCT01208948|"~     To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular~     edema.~   "
141023|NCT01208935|"~     The purpose of this study is to test the safety, tolerability, compliance and efficacy of~     two different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch~     and the nicotine gum) in a nicotine-dependent adolescent population.~   "
141024|NCT01208922|"~     The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus~     Ciprofloxacin for the treatment of adults with traveller's diarrhoea.~   "
141025|NCT01208909|"~     In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually~     considered a a first step of effective therapy. Radical resection of the tumor is highly~     beneficial to the patient as measured in progression-free survival and overall survival. At~     the same time eloquent areas of the brain have to remain intact to preserve quality of life.~      Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor~     tissue and thereby to improve precision of GBM-Resection.~      We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases~     the number of sites where tumor tissue can be detected.~      - Trial with surgical intervention~   "
141026|NCT01208896|"~     This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell~     transplantation including Rituximab in the conditioning regimen for the treatment of~     relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control~     of the disease and a better prophylaxis of the graft versus host disease.~   "
141027|NCT01208883|"~     Treatment adaptation to biological and anatomical changes occurring during treatment can~     increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer~     patients. This trial investigates the feasibility of using repetitive per-treatment~     [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based~     intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head~     and neck cancer.~   "
141028|NCT01208870|"~     The purpose of this center grant is to translate basic behavioral science on habituation~     theory into clinical intervention using a vertical hierarchical approach from laboratory~     studies to field studies to the clinical intervention to improve weight loss outcomes in~     pediatric obesity treatment.~   "
141029|NCT01208844|"~     The purpose of this study is to obtain a better understanding of how stress is related to~     health risks.~   "
141030|NCT01208831|"~     The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase~     II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e.,~     Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite~     standard therapy or for which no standard therapy exists.~   "
141031|NCT01208818|"~     MYRE is a phase III multicentric controlled national clinical trial conducted in patients~     with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims~     are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with~     cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN~     not requiring hemodialysis; and (2) in patients with inaugural severe renal failure~     secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis~     regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a~     conventional high-flux dialyser, while receiving chemotherapy with BD.~   "
141032|NCT01208805|"~     The study first aim is to investigate the relationship between different patterns of~     electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials~     to optimize spinal cord stimulation parameters . The second aim of the study is to~     investigate the role of the spinal cord in some aspects of cognitive-sensory-motor~     processing, specifically the presence of top-down attentional effects on the sensory~     analysis of an external stimulus at the spinal cord level.~      The study will be performed on patients that will be implanted with a spinal epidural~     electrode because of chronic intractable pain. From these electrodes, spinal cord evoked~     potentials (SCEPs) will be recorded.~   "
141033|NCT01208792|"~     The investigators have recently evidenced the presence of antibodies to endothelial cells~     and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also~     have identified several target antigens of anti-fibroblasts antibodies.~      The objective of this study is to further investigate for the presence of antibodies to~     endothelial cells and fibroblasts in patients and characterize the antigen specificity of~     autoantibodies in patients with different types of non idiopathic and non SSc-associated~     PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital~     heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's~     syndrome~   "
141034|NCT01208779|"~     This observational study in estrogen receptor positive early breast cancer patients is aimed~     to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect~     country-specific data in estrogen receptor positive early breast cancer patients including~     data on demography, disease characteristics and disease management.~   "
141035|NCT01208766|"~     Study phase: phase III~      Study objective:~        -  Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed~          autologous stem cell transplantation (ASCT)~        -  Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no~          consolidation~        -  Comparison of single versus tandem high dose Melphalan with ASCT~      Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS~     stages 1-3, age 18-65 years inclusive~      Study design: Prospective, multicenter, intergroup, randomized~      Duration of treatment: Expected duration of induction, stem cell collection and~     intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance~     therapy with Lenalidomide will be given until relapse. All patients will be followed until~     10 years after registration.~   "
141036|NCT01208753|"~     The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and~     to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous~     suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and~     pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.~   "
141037|NCT01208740|"~     Metformin should be administered with caution and could be potentially dangerous in~     infertile patients with PCOS who show a poor ovarian response and are undergoing~     gonadotropin-based ovarian stimulation. However, data that address this point are totally~     lacking.~      On the basis of these considerations, the aim of the current clinical trial was to test the~     hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who~     have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF~     cycles.~   "
141038|NCT01208727|"~     After having shown that postconditioning allowed a significant 36% reduction of infarct size~     as assessed by blood levels of myocardial enzymes in acute myocardial patients, the~     investigators objective is to assess the effect of postconditioning in acute myocardial~     infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI~     images.~   "
141039|NCT01208714|"~     Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT).~     Since there are still uncertainties as to whether and in what patients revascularization by~     means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study~     exploiting an optimized patient selection strategy and using hard experimental endpoints to~     unravel these uncertainties.~      Primary objective: to determine if revascularization by means of PTRAS is superior or~     equivalent to optimal medical treatment for preserving glomerular filtration rate in the~     ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.~      Secondary objectives: to determine if the two treatments are equivalent in lowering blood~     pressure (BP), preserving overall renal function and regressing damage in the target organs~     of hypertension.~      Design: prospective multicenter randomized, unblinded two-arm study.~      Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral~     RAS, defined by stenosis of the proximal portion of the renal artery and its main~     bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could~     bias the assessment of the outcome of revascularization.~      Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT~     either > 70% or, if < 70 with post-stenotic dilatation.~      Renal function will be assessed with 99mTc-DTPA renal scintigraphy.~      Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference~     in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.~      Arms~        1. Revascularization: digital scan angiography and PTA with stenting of the renal artery~          at the ostium or at truncular level, plus optimal medical therapy.~        2. Medical therapy: the drug regimen that had been optimized during the run-in period.~      Experimental endpoints:~      The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as~     quantitative variable and compared between groups at each time point. A categorical~     definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be~     also used and the rate of achievement of such endpoint will be compared.~      Duration: 5 years.~   "
141040|NCT01208701|"~     It has been documented that statin reduce mortality and morbidity in patients with~     cardiovascular disease. This effect can partly be related to a reduction in cholesterol~     levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as~     nephropathy, diabetes and hypertension. The purpose of this study is to investigate the~     effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular~     variables in patients with type 2 diabetes with nephropathy.~   "
141314|NCT01205204|"~     The purpose of this study is to evaluate the safety, quality and duration of block with the~     addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with~     addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.~   "
141041|NCT01208688|"~     The main objective of this study is to determine the effectiveness of a new treatment regime~     that uses electrical stimulation for the improvement of hand function in persons with spinal~     cord injuries (SCI). This treatment has been shown to be useful for stroke patients, and our~     preliminary work indicates that this may also be the case with SCI patients. Our approach to~     functional electrical stimulation (FES) represents a departure from the established FES~     approaches, which involve developing assistive devices for permanent, everyday use. Instead,~     we use FES as a therapeutic intervention that will help individuals with quadriplegia~     recover voluntary grasping function. Investigators believe that subjects who undergo FES~     therapy should be able to grasp objects without stimulation once the treatment program is~     completed.~   "
141042|NCT01208675|"~     The present study aims at combining biochemical methods with various types of imaging~     techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is~     to find markers associated with the very early steps in the pathology of this disease. The~     investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma~     specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed~     clinical assessments.~      Biomarkers of interest would then be useful to:~        1. Enable accurate detection of the disease early on. Such biomarkers need to specifically~          reflect the very early pathophysiology of AD and distinguish it from disorders with~          similar symptomatology, such as other types of dementia and major depression. The~          sensitivity and specificity of these biomarkers in combination with clinical assessment~          should be of at least 90%.~        2. Enable prediction of the course of events of the disease, such as the disease rate in~          individual patients. Biomarkers that can predict the pattern of future symptoms will be~          extremely valuable.~        3. Allow monitoring of early effects of new disease-modifying therapies (so-called~          surrogate biomarkers). Currently clinical therapeutic trials for AD require large~          patient groups together with long-term treatment. Both size of the groups and treatment~          time will be reduced with the help of surrogate biomarkers.~        4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail~          early alterations in AD patients. For instance, changes in the levels of certain~          molecules in CSF together with genetic predisposition could then be correlated to~          clinical signs and changes detectable by brain imaging. This can lead to identification~          of new therapeutic targets that could easily be monitored in future trials.~   "
141043|NCT01208662|"~     The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have~     not been approved in the combination for multiple myeloma or any other type of cancer.~     Bortezomib is currently approved by the FDA for the treatment of multiple myeloma.~     Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who~     have received at least one prior therapy and for the treatment of certain types of~     myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is~     commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.~     Please note that Bortezomib and Lenalidomide are provided to patients participating in this~     trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell~     collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved~     chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to~     stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with~     other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma~     studies and information from those studies suggests that this combination of therapy may~     help to treat newly diagnosed multiple myeloma.~      In this research study, we are looking to explore the drug combination, lenalidomide,~     bortezomib and dexamethasone alone or when combined with autologous stem cell~     transplantation to see what side effects it may have and how well it works for treatment of~     newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine~     if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial~     management of multiple myeloma in younger patients. In this study, HDT as compared to~     conventional dose treatment would be considered superior if it significantly prolongs~     progression-free survival by at least 9 months or more, recognizing that particular~     subgroups may benefit more compared to others.~   "
141044|NCT01208649|"~     The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide~     will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning),~     summarized in the recently introduced NASH-score in patients with normal, impaired or~     diabetic glucose tolerance compared to dietary guidance alone.~   "
141045|NCT01208636|"~     The purpose of this study is to determine the effect of environmental and genetic influences~     on Vitamin D status.~   "
141046|NCT01208623|"~     Patients with chronic lower limb edema commonly suffered from extremities edema, pain,~     varicosities, venous stasis changes, and deep venous thrombosis. A common challenge for~     primary care physicians is to determine the cause and find an effective treatment for leg~     edema of unclear etiology. The aims of this project are to determine the cause of patients~     with chronic lower limb edema with conventional digital venography, the clinical value of~     role of 3D rotational venography or combined multidetector (MD)CT angiography and iliac~     venography using direct iliac venography for contrast administration via bilateral femoral~     catheterization (MDCT angiography/venography) with volume-rendering images supplementary to~     2D digital venography in evaluation of patients with chronic lower limb edema.~      This project is designed as retrospective cross-sectional study. Between April 2008 and Dec~     2009, a total of approximately 300 patients with chronic lower limb edema who had had~     bilateral iliac digital venography and surgery at our institution will be reviewed. All~     patients underwent surgery by one senior vascular surgeon for lower limb conditions within~     one month after the venographic examination. Patients who had incomplete clinical and~     surgical records or incomplete images will be excluded. The surgical findings of the~     presence, anatomical location, and size of the venous narrowing will assessed and described.~     Stenosis was defined as luminal narrowing of 50% or more compared to the prestenotic or~     poststenotic lumen.With use of surgical findings as a the standard, the investigators~     calculated and compared the diagnostic accuracies, sensitivities, specificities, positive~     predict values and negative predict values of 2D digital venography images alone, 3D~     rotational venography, and combined MDCT angiography/venography with volume-rendering images~     supplementary to 2D digital venography.~      With this large series study, the investigators believe that the cause of chronic lower leg~     edema in our patients' population will be clarified. The value of additional 3D rotational~     venography, and combination MDCT angiography/venography with volume-rendering images will~     lead to higher diagnostic performance and may provide a helpful tool for planning surgical~     and endovascular treatment, which has not been reported before.~   "
141047|NCT01207622|"~     The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in~     the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD)~     with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to~     determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has~     demonstrated that ATMX has led to significant improvement in ADHD in children and lacks~     abuse liability, the investigators hypothesize that ATMX will be efficacious in treating~     ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in~     preventing SUD relapse.~   "
141048|NCT01207609|"~     The purpose of this study is to collect data prospectively on the safety and efficacy of the~     Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.~      The 95% confidence interval for average percentage of weight loss and body mass index will~     be computed at 6 months, one year and then annually. Analysis of comorbid conditions~     changes, quality of life and adverse events will be performed. With 50 subjects in the~     study, limited power is expected and no formal hypothesis testing will be performed.~   "
141049|NCT01207596|"~     The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with~     neuropathic pain.~   "
141050|NCT01207583|"~     This study is planned to monitor the local and/or systemic reactions and compatibility of~     PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with~     the observational nature of this protocol, Prevenar will be administered as standard of~     care.~      The aim of this study is to estimate the incidence of febrile reactions more than 38.0~     degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40~     degrees C, and the frequency of other local or systemic reactions following vaccination with~     Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions~     of routine daily use in the Russian Federation.~   "
141051|NCT01207570|"~     Children with developmental disabilities often sustain decreased range of motion in their~     extremities. The decrease in flexibility may be due to neuromuscular disorders such as~     spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a~     joint, leading to inappropriate habitual posture. Over time, muscle contracture may result~     for those muscle groups that are placed in a shortened position for an extended period of~     time. The most common site of muscle contractures among these children are~     gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle~     contractures can lead to further decline in functional abilities. Therefore, it is important~     to identify effective intervention strategies to enhance or maintain muscle flexibility in~     children with developmental dysfunctions.~      Commercially available endermotherapy device has been used to soften scar tissue following~     burn injuries. The mechanical stimulation applied may also have beneficial effects on~     relaxing the muscle tissue. The overall aim of the proposed study is to determine whether~     endermotherapy treatment has immediate effect in improving joint range of motion among~     children with developmental disabilities.~      The research hypothesis is that children in the endermotherapy group will have significantly~     more gain in ankle passive range of motion than those in the control group.~   "
141052|NCT01208610|"~     The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About~     Pregnant Women's Service Quality and Satisfaction~   "
141053|NCT01208597|"~     Owing to its image resolutions and its convenience in diagnosis, both better than abdominal~     ultrasound, transvaginal ultrasound is nowadays widely applied in diagnosing practice in~     obstetrics and gynecology. As a result, female examinees who undergo these check-up~     procedures have to expose their private parts, instead of their abdomens like the old days.~     According to the literature, women who receive transvaginal ultrasound check-ups normally~     have anxiety reactions, and worry about pain and discomfort. In clinical practice, when~     giving advice to the examinees to go through this check-up, more than often the diagnosis~     itself is its sole purpose, and little psychological assistance is offered. Traditional~     clinical space and disposal process tend to be designed to serve the purposes of conforming~     to the customs of medical staff and to the integrity of human resources and facilities in~     the hospital managers' minds, and less frequently tend to take the needs of patients into~     consideration. Consequently these patients are forced to enter strange medical environments~     and accommodate to the existent medical systems, with physical and psychological~     discomforts, to suffer from even more uncomfortable and anxiety-causing check-ups. Current~     medical service is required to not only provide a clean environment, but also give attention~     to creating an artistic space to increase healthy factors to the environment. The literature~     points out that a comfortable and artistic space can eliminate environmental strangeness,~     and help patients to soothe their pressures caused by their own and by the environment.~   "
141054|NCT01208584|"~     The purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR)~     diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in~     patients with congenital (birth defect of the spinal column), acute and chronic complete~     spinal cord lesions. The findings of this study may provide a basis to better understand the~     pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord~     lesions in man. This understanding is important for the improvement of existing therapies~     and for the development of new therapeutic approaches.~   "
141055|NCT01208571|"~     The effect of alcohol interventions seems to be related to the intensity of the~     interventions. In this study the investigators will assess the effect of a interdisciplinary~     booster session in primary care, given to patients who were admitted to hospitals with~     alcohol related conditions, and who were given Brief Intervention before discharge. The~     booster session is based on a motivational interview.~   "
141056|NCT01208558|"~     The main purpose of this 2-year lifestyle experiment for waist loss is twofold:~        1. to compare whole grains and no grains as part of a healthy diet,~        2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient~          than brief counseling and follow-up.~      People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one~     additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior~     cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a~     structured exercise program at the department of physiotherapy, or to a control group~     receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat~     dairy products, and differ only in that Diet A recommends exchange of cereal grains for more~     potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends~     exchange of regular cereal grains for whole grains. The primary outcome (most important~     follow-up variable) is change in waist circumference during 2 years. Secondary outcome~     measures include blood pressure, blood lipids, level of physical activity and, in subjects~     with diabetes, glycated hemoglobin and fasting blood sugar.~   "
141057|NCT01208545|"~     The study hypothesis is that changes in serially obtained nerve conduction study data~     obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict~     the development of a clinically significant / disabling drug induced neuropathy six and~     twelve months following the start of treatment. Patients with breast cancer, colon cancer,~     gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity~     nerves--three in each leg--will be electrically stimulated and their responses recorded at~     three to four week intervals coinciding with patient's scheduled chemotherapy.~   "
141058|NCT01208532|"~     The aim of this study is to evaluate the reliability and validity of the Korean version of~     the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module~     (EORTC HDC-29).~   "
141070|NCT01208376|"~     Little is known about the clinical significance of chronic alanine aminotransferase (ALT)~     elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first~     to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with~     chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and~     second to find associated factors with significant fibrosis and cirrhosis. In a second~     longitudinal part we intend to assess fibrosis progression within 1 and 3 years.~   "
141376|NCT01204294|"~     The objective of the current study is to investigate the safety and efficacy of linagliptin~     (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes~     mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one~     approved antidiabetic drug.~   "
141059|NCT01208519|"~     The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic~     Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6~     medical wards will participate in the study. Sites of the study are located in 3 countries~     (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of~     methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase~     (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among~     different treatment groups and define the temporal relationship between the start of~     antibiotic therapy, the acquisition of new colonisation in patients previously not~     colonised, and the development of a bacterial infection caused by the same strain isolated~     in a screening sample. This goal will be achieved by completing the following primary~     objectives:~        -  To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000~          antibiotic-days according to different classes of antibiotics, duration of therapy and~          antibiotic combination (monotherapy versus combination therapy);~        -  To determine genotypic relation between colonising and infecting strain in the same~          patient and patients' and hospital staff colonising strains (to be performed in~          collaboration with WP1 of the SATURN project);~        -  To study the virulence and fitness of the isolates (i.e. new colonising strains)~          causing subsequent nosocomial infections (to be performed in collaboration with WP1 of~          SATURN project);~        -  To predict the risk for nosocomial infections due to target bacteria after a single~          treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.~   "
141060|NCT01208506|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetic (the effect of the body on the investigated drug),~     pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and~     signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels~     in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and~     at 3 s.c. dose levels in Healthy Subjects.~   "
141061|NCT01208493|"~     In this randomized study The investigators aim to compare the growth of~     very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm~     infant formula.~      Babies will be fed the assigned formula between the time they achieve full enteral feeds and~     hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and~     compared between groups. Feeding tolerance, protein-energy status and body composition~     between the study groups will also be analysed.~      After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between~     hospital discharge and 3 m corrected age.~   "
141062|NCT01208480|"~     RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such~     as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving bevacizumab together~     with docetaxel and carboplatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel~     and carboplatin works in treating women with operable Stage II or stage III breast cancer.~   "
141063|NCT01208467|"~     This research study is studying prognostic biomarkers in tissue samples from patients with~     endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory~     may help doctors learn more about changes that occur in DNA and identify biomarkers related~     to cancer.~   "
141064|NCT01208454|"~     This phase I trial is studying the side effects and the best dose of vorinostat when given~     together with isotretinoin to see how well it works in treating patients with high-risk~     refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work~     better by making tumor cells more sensitive to the drug. Giving vorinostat together with~     isotretinoin may be an effective treatment for neuroblastoma.~   "
141065|NCT01208441|"~     This phase I trial is studying the side effects and best dose of RO4929097 when given~     together with letrozole in treating post-menopausal women with stage II or stage III breast~     cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving~     RO4929097 together with letrozole may be an effective treatment for breast cancer.~   "
141066|NCT01208428|"~     Duke University Medical Center in collaboration with Glendale Adventist Medical Center~     propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs.~     religious cognitive behavior therapy (RCBT) for major depression in medical patients with~     chronic disabling illness. Therapists will deliver the treatment in real time over the~     Internet and/or by telephone to increase treatment access. This planning grant seeks support~     for a two-site study (North Carolina and California) that consists of two phases. In Phase I~     (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess~     subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with~     treatment, acceptability of treatment and delivery system (online vs. telephone), and allow~     therapists gain experience with delivery system and RCBT.~      In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept~     comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected~     clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious~     patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the~     Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be~     randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions~     administered by master's level therapists and delivered over 12 weeks. The primary endpoint~     will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu,~     Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each~     of these traditions will supervise therapists delivering the intervention to patients from~     these faith traditions.~      The purpose of this study is to determine feasibility and effect sizes for a future, fully~     powered treatment study. The importance is that results will be relevant to therapists well~     beyond those who explicitly practice pastoral counseling, extending to many secular~     therapists as well. If 65% of Americans indicate that religion is an important part of daily~     life and the vast majority of chronically ill medical patients wish to include it in their~     therapy, then all therapists (whether they have explicit training in pastoral counseling or~     not) are likely to encounter patients in which this approach would be applicable.~   "
141067|NCT01208415|"~     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the~     safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in~     combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the~     treatment of aorto-iliac and iliac aneurysms.~   "
141068|NCT01208402|"~     The purpose of this study is to find out if Esmolol is a safe and effective alternative~     treatment compared to standard treatment using a long acting beta blocker drug, in~     controlling abnormal heart rate before, during and immediately after surgery.~   "
141071|NCT01208363|"~     Rationale: Iron deficiency and zinc deficiency, are of public health significance in~     sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer~     from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been~     designed and implemented over the years towards solving hunger and anaemia especially among~     school age children. One of such interventions is School Feeding Programme (SFP) which is~     common in both developing and industrialized countries. SFP has been part of the Ghanaian~     educational system for well over 40 years, albeit on small scale. The main stay of the~     programme that makes it distinguishable from other past and existing school feeding~     programmes is its reliance on locally produced and available foods, such as cowpeas. Legume~     staples like cowpea have been identified to be important sources of protein and non-heme~     iron to rural populations of developing countries like Ghana. The problem however is the low~     bioavailability of these micronutrients from these legumes.~      Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving~     iron status of primary school children in rural northern Ghana Study design: A randomized~     double blind parallel design will be conducted. One group will receive iron fortified Tubani~     with NaFeEDTA and the other group will receive unfortified Tubani.~      Study population: Two hundred and forty apparently healthy pupils in lower primary school~     will participate. The participating schools have a school feeding programme currently in~     operation.~      Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification~     iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and~     blood samples will be measured at baseline and after six months of intervention.~     Participants will be treated against intestinal parasites before start of intervention and~     halfway through the intervention.~      Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA).~     IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected~     for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and~     C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and~     iron deficiency will be defined as an SF concentration <12 µg/L.~      Venipunctures occasionally lead to bruises or small local inflammation which usually~     disappear within one week. To minimize this risk, blood collection will be performed by a~     trained and experienced phlebotomists. Written informed consent will be obtained from all~     subjects.~   "
141072|NCT01208350|"~     This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel~     ways of structuring financial incentives to motivate and sustain long-term weight loss. The~     study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to~     participate in a 6-month weight loss program and an additional 3-month follow-up period. The~     primary outcome measure in this randomized control trial will be pounds of weight lost~     between baseline and 6 months. The goal of this study is to evaluate whether a novel~     financial incentive program delivered through a workplace can effectively encourage~     sustained weight loss among obese employees.~      The study hypotheses are 1) mean weight loss will be greater in all the intervention groups~     compared to the control group by the end of the 24-week intervention period; and 2)~     individuals in the intervention groups will have a lower mean weight at the end of the~     12-week follow-up period than individuals in the control group.~   "
141073|NCT01208337|"~     This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab~     (Campath, Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving~     intestinal transplant. Seventy-five subjects receiving primary or repeat intestine~     transplantation will be enrolled. Primary endpoints include the incidence and severity of~     biopsy-proven acute cellular rejection, the incidence of freedom from steroids at 5 years,~     and the incidence of subjects with steroid-free Tacrolimus at whole blood concentrations <~     10 ng/ml. Secondary endpoints include a) incidence and severity of opportunistic infections~     (CMV and EBV), post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b)~     use of non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte~     subsets, d) longitudinal characterization of donor-specific alloreactivity in mixed~     lymphocyte responses (MLR), to identify the time at which it decreases to a level less than~     third-party-specific alloreactivity e) longitudinal expression (mRNA) of genes, to identify~     rejection- and non-rejection-specific genes and f) characterization of whole genome~     mutations, which show differences in parent-to-child transmission between rejectors and~     non-rejectors. This will identify rejection- and non-rejection-specific genes bearing~     genetic variants, which might impact on gene function, and complement candidate gene~     identification efforts based on SNP transmission.~   "
141074|NCT01208324|"~     The aim of this study is to examine the effects of estrogen and serotonin on cognition,~     emotional processing, and brain activation. The investigators will study the effects of~     acute tryptophan (TRP) depletion on cognition and mood in healthy menopausal women before~     and after estrogen replacement treatment (ERT). Using functional magnetic resonance imaging~     (fMRI), the investigators will identify differences in brain activation during memory tasks~     with and without TRP depletion and before and after estrogen therapy in order to determine~     which brain regions and cognitive functions are affected by each manipulation.~   "
141075|NCT01208311|"~     The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C~     patients with advanced fibrosis, using endoscopic ultrasound.~   "
141076|NCT01208298|"~     The primary objective of this study was to evaluate the safety and performance of a cold~     sore patch for the treatment of herpes labialis.~   "
141077|NCT01208285|"~     The purpose of this study is to investigate the pharmacokinetics and safety of a single dose~     of VX-770 in subjects with moderate hepatic impairment.~   "
141078|NCT01208272|"~     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating~     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but~     its long-term impact and time course on other BED-related symptoms remain largely unknown.~     This study compares the effects of group CBT and group IPT across BED-related symptoms among~     overweight individuals with BED.~   "
141079|NCT01208259|"~     Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating~     disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but~     its long-term impact and time course on other BED-related symptoms remain largely unknown.~     This study compares the effects of group CBT and group IPT across BED-related symptoms among~     overweight individuals with BED.~   "
141080|NCT01208246|"~     The purpose of this study is to understand the effect of the pregnancy on the muscles in the~     pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to~     pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on~     delivery mode and if there are any injuries to the pelvic muscles.~   "
141081|NCT01208233|"~     The purpose of this study is to evaluate the safety and tolerability of PF-03049423~     following multiple dose administration to subjects with ischemic stroke. The study will also~     evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke~     following 90 days of therapy. The study will also explore the relationship between~     PF-03049423 concentration and blood pressure.~   "
142492|NCT01189513|"~     The goal of this clinical research study is to find the highest tolerable dose of SCH 900105~     that can be given to patients with glioblastoma before surgery. The safety of this drug will~     also be studied.~   "
141082|NCT01208220|"~     Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a~     device which by themselves are effective for the treatment of wounds.~      You are being asked to take part in this study because you have a wound on your body which~     has not responded to standard treatments.~      The researchers will be studying whether the combination of two treatments will make wounds~     heal faster. For those in study, the investigators will treat them with a vacuum device on~     their wound. Also, some of the people in the study will receive a special ointment and~     researchers will use special tests to determine if the two treatments together are working~     better than just one treatment alone.~   "
141083|NCT01208207|"~     The purpose of the study is to evaluate the efficacy and tolerability of two doses of~     etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary~     objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of~     treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the~     improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg~     compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of~     etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary~     hypothesis is that the improvement in Spinal Pain Intensity visual analog scale (VAS) as~     measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment~     in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.~   "
141084|NCT01208194|"~     This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate~     efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to~     placebo control. The study will be conducted in patients with advanced colorectal carcinoma~     (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.~   "
141085|NCT01208181|"~     This is a 2-part (6 weeks duration for each part), randomized, double-blind,~     placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that~     etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to~     placebo after 6 weeks of treatment, as measured by the greater mean improvement from~     baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater~     mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of~     treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg~     to 90 mg will be assessed in the second part of the study.~   "
141086|NCT01208168|"~     The objectives of this study are to assess the safety of NAB001 for topical treatment of~     mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the~     efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52~     weeks.~   "
141087|NCT01208155|"~     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets~   "
141088|NCT01208142|"~     The purpose of this study is to examine the change in ankle plantar flexion while walking,~     following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as~     Toe Walkers.~      For twelve weeks, patients will either receive the standard treatment or the same standard~     treatment and the Dynaslint worn at night.~   "
141089|NCT01208129|"~     The objectives of this study are to assess the safety of NAB001 for topical treatment of~     mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the~     efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52~     weeks.~   "
141090|NCT01208116|"~     The purpose of this study is to determine whether non-invasive atherosclerotic measurements~     (baPWV, IMT, FMD, CACS, ABI) are valuable predictors for cardiovascular events in elderly.~     At inception, routine physical examination and non-invasive atherosclerotic measurements~     will conducted on all participants. Then they will be followed prospectively for at least 2~     years. All cardiovascular and other health events will be recorded.~   "
141091|NCT01208103|"~     The goal of this clinical research study is to learn if the combination of capecitabine,~     oxaliplatin, and bevacizumab can help to control cancer of the small bowel or ampulla of~     Vater. The safety of this drug combination will also be studied.~   "
141092|NCT01208090|"~     This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in~     patients with moderate-to-severe chronic plaque psoriasis.~   "
141093|NCT01208077|"~     This multinational registry (3 USA, 2 European centers) will capture in the ED continuous~     non invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients~     presenting with acute heart failure, stroke syndromes and systemic infection. Patients will~     be observed after their Emergency Department (ED) disposition to determine clinical outcomes~     (length of stay in the hospital, the development of any organ dysfunction, mortality and~     need for unscheduled medical care within the ensuing 30 days). It is anticipated that~     specific ED hemodynamic profiles will be predictive of better clinical outcomes than others.~     This information will provide the outcome data needed to design future therapeutic trials~     that will evaluate the effect of ED hemodynamic manipulations on overall patient management~     and outcomes.~   "
141094|NCT01208064|"~     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet~     known whether pazopanib hydrochloride is more effective than a placebo in treating patients~     with non-small cell lung cancer that has not progressed after first-line chemotherapy.~      PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib~     hydrochloride works and compares it with giving a placebo in treating patients with~     non-small cell lung cancer who have received first-line chemotherapy.~   "
141095|NCT01208051|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     cediranib maleate when given together with or without lenalidomide and to see how well they~     work in treating patients with thyroid cancer. Cediranib maleate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop~     the growth of thyroid cancer by blocking blood flow to the tumor. It is not yet known~     whether cediranib maleate is more effective when given together with lenalidomide in~     treating thyroid cancer.~   "
141377|NCT01204281|"~     To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+)~     (objective 80% gain) as main ventilatory support in early stage of critically ill patients~     in comparison with standard volume-assist control ventilation (ACV).~   "
141096|NCT01208038|"~     A woman's ovaries produce the hormone testosterone during her reproductive life but~     testosterone levels decline with age or when the ovaries are removed. Testosterone has been~     associated with sexual desire in both men and women. Low testosterone is also believed to~     cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement~     regimens to restore libido and energy in postmenopausal women.~      In the past testosterone has been administered orally or via subcutaneous implants. Recently~     testosterone patches have been licensed for treating low libido in postmenopausal women. The~     testosterone patches deliver a dose of testosterone equivalent to the levels produced by the~     ovary during a woman's early reproductive years.~      Oral testosterone can lead to changes to insulin and cholesterol levels which increase the~     risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk.~     To date, trials have predominantly focused on safety data in terms of side effects and basic~     blood tests. Reviews of the safety of testosterone replacement have emphasised the need for~     improved safety data, especially in terms of cardiovascular risk.~      The purpose of this study is to examine the effect of the testosterone patch, in addition to~     hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.~      The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no~     adverse effects on blood vessel walls and insulin levels and that transdermal testosterone~     significantly improves sexuality and psychological well-being in postmenopausal women.~      Trial design:~      The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for~     3 months in addition to their usual hormone replacement therapy.~      There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the~     following procedures will be performed:~        -  Medical history and physical examination~        -  Blood sample - for hormone levels, lipids and insulin levels~        -  Blood vessel stiffness measurements This will be performed using a small ultrasound~          device at the wrist with blood pressure measured every 5 minutes.~        -  Endothelial function (function of your arterial wall) is measured using a blood~          pressure cuff on each arm and finger probes on one finger of each hand. The blood~          pressure cuff is inflated for 5 minutes and is then deflated quickly. The finger probes~          will record the readings throughout this study.~        -  Sexual satisfaction questionnaire~   "
141097|NCT01208025|"~     The possibility of the identification of the risk of rupture of a carotid plaque will have~     tremendous impact in clinical decision making. Firstly, in symptomatic patients with a~     30-69% stenosis, who are currently not operated upon according to the current guidelines,~     identification of the risk of rupture plaque could identify patients who have a high risk of~     recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent~     placement. This could potentially prevent a substantial number of strokes. Secondly, in all~     symptomatic patients with a 70-99% stenosis carotid intervention should be considered,~     according to the guidelines. However, only one out of six patients with a 70-99% stenosis~     benefits from a carotid intervention. Identification of patients with a high risk of a~     recurrent stroke would reduce the number of unnecessary interventions substantially.~      The main objective is to show whether imaging characteristics assessed at baseline can~     predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.~   "
141098|NCT01208012|"~     The trial is a phase IV clinical trial investigating the impact of Liraglutide on~     endothelial function and microvascular blood flow in 44 patients with type 2 diabetes~     mellitus aged 30-65 and HbA1c ranging from ≥ 5.5% ≤ 7.0%. The patients will be randomized~     into two study arms, one arm will be treated with Metformin monotherapy, the second arm will~     be treated with Metformin and Liraglutide at an increasing dose (0.6 mg/day to 1.8 mg/day.)~   "
141099|NCT01207999|"~     The aim of the study is to assess the distribution of the most frequent types of human~     papillomavirus in African women diagnosed with invasive cervical cancer.~   "
141100|NCT01207986|"~     Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history~     with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this~     study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography~     (CT) in a HIV-infected population with an important smoking history. Other objectives are~     (1) the evaluation of the types of lung cancers in this population, as well as (2) the~     staging of non small cell lung cancers, (3) the description of risk factors for all lung~     cancers, if they are numerous enough, and (4) the number of complications of diagnosis~     procedures during the study.~   "
141101|NCT01207973|"~     The objective of the study is to investigate the safety and tolerability of BI 113823 in~     male and female patients with osteoarthritis, following oral administration of BI 113823~     with repeated rising doses.~   "
141102|NCT01207960|"~     The purpose of this study is to find out whether Eye Movement Desensitization and~     Reprocessing (EMDR) is effective in the treatment of patients with dental phobia.~   "
141103|NCT01207947|"~     Main object is to investigate the safety profile of Levitra in combination use with~     alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.~      In the initial combination date and the first and second observation after initial~     combination date, number of tablets prescribed, dose of tablets and number of tablets taken~     until follow-up visit will be investigated. The efficacy and tolerability will be evaluated~     at 2 months after initial combination date.~   "
141104|NCT01207934|"~     Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not~     known whether it improves insulin action in persons who are not leptin deficient. The~     purpose of the present study was to determine whether leptin therapy has effects on insulin~     action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo~     controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were~     randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was~     measured.~   "
141105|NCT01207921|"~     The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in~     patients with relapsed Hodgkin lymphoma after autologous transplant~   "
141106|NCT01207908|"~     The purpose of this study is to determine whether IGF-1 therapy improves or preserves muscle~     function in Duchenne Muscular Dystrophy (DMD).~   "
141107|NCT01207895|"~     The purpose of this study is to determine if positron emission tomography (PET) imaging with~     an imaging agent called 18F-fluorodeoxythymidine([18F]-FLT) will allow investigators to~     measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy).~     Additionally, the investigators want to determine if it is possible to predict how well~     tumor(s) might respond to treatment with [18F]-FLT PET imaging.~   "
141108|NCT01207869|"~     Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth~     arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely~     premature infant with severe BPD to establish whether intratracheal instillation of~     umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe~     BPD.~   "
141109|NCT01207856|"~     Despite the need for cognitive rehabilitation, there is a paucity of well-designed research~     studies to investigate treatment approaches or their effectiveness in MS. Most of published~     studies suffer from significant methodological flaws including small sample size, short~     follow-up periods, and lack of specific outcome criteria to determine improvement. O'Brien~     et al. (2008) recently reviewed 16 studies of cognitive rehabilitation designed to persons~     with MS and found only 4 class I studies and only one class I study of rehabilitation of~     attention deficits. Methodologically rigorous research is needed to confirm the preliminary~     results reported by these studies and determine the effectiveness and efficacy of cognitive~     rehabilitation interventions in attention deficits in MS. O'Brien et al. listed limitations~     found in previous studies that must be addressed in future studies. The present study was~     designed according to these recommendations. It is a randomized, controlled study, in~     parallel groups, evaluator blinded.~      Number of participants: 25 RRMS patients in the active group, 25 RRMS patients in the~     control group and 25 healthy subjects.~      The protocol will be proposed to RRMS patients AFFILIATED TO FRENCH SOCIAL SECURITY referred~     to the investigators center by practicing neurologists and fulfilling the inclusion criteria~     for screening.~      Patients will be randomised between two groups. The active group (25 patients) will be~     treated by rehabilitation. Individual rehabilitation procedures will be focused on~     attention, executive functions and IPS. The program will be tailored to each patient~     cognitive status depending on the impairments identified during the initial assessment while~     maintaining a systematic work on attention and executive functions. A total of 50 sessions~     lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be~     proposed. Patients randomized in the other group will participate to group session every~     week without specific cognitive rehabilitation. 25 healthy control subjects (group C),~     matched to patients for education, gender and age with patients of groups A/B will have the~     same evaluation procedures than patients.~      Evaluation will be performed at baseline, after 4 months (end of treatment period) and after~     8 months. Evaluation will include clinical testing, cognitive battery (paper/pencil and~     computer tests), cognitive ecological evaluation (Computer test of attention in a virtual~     reality environment and driving test on a driving simulator), questionnaires about daily~     life and MRI (fMRI and MRI). All patients and healthy subjects will undergo the fMRI~     protocol using a paradigm previously published by the investigators group (Bonnet et al.,~     2009): Go/No-go paradigm with increasing difficulty during four successive conditions (the~     Tonic Alertness task, Go/No-go (IG), reversal Go/No-go (RG), and complex Go/No-go (CG). In a~     previous study the investigators observed compensatory activation in MS patients as compared~     to healthy controls for the three first conditions and a saturation of compensatory~     processes for the more complex. In the present study, the investigators hypothesize that a~     similar pattern will occur at baseline and that cognitive rehabilitation will improve brain~     compensation at the fourth level of complexity.~   "
141378|NCT01204268|"~     The current study is designed to clarify the neuroprotective effect of sevoflurane~     preconditioning on the patients underwent intracranial aneurysm surgery.~   "
142755|NCT01186094|"~     This randomized study is a multi-center, randomized, study to compare the efficacy of~     sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for~     long coronary lesions.~   "
141110|NCT01207843|"~     Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy~     for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans,~     but there is no standardized CT protocol for the diagnosis and follow-up of hepatic~     candidiasis.~      The investigators compared the size of the fungal lesions in the chest and abdomen CT. The~     current analysis aimed to increase the value of CT for the diagnosis and the follow-up of~     hepatic candidiasis in daily routine.~   "
141111|NCT01207830|"~     The purpose of this study is to provide initial clinical data to support the feasibility of~     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution~     in morbidly obese subjects~   "
141112|NCT01207817|"~     The purpose of this study is to determine the effects of varying luminescent levels on the~     pupillary response.~   "
141113|NCT01207804|"~     The purpose of the study is to provide initial clinical data to support the feasibility of~     use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution~     in morbidly obese patients.~   "
141114|NCT01207791|"~     Misuse of drugs and alcohol has a tremendous impact on individual health and on society, in~     terms of both human suffering and economic cost. Most substance abusers never seek specialty~     addiction treatment, but a large percentage of them receives some form of medical care,~     frequently in emergency room settings. There is considerable evidence showing that~     Screening, Brief Intervention, Referral, and Treatment (SBIRT) interventions in medical~     settings result in decreased drinking and alcohol-related problems among those with alcohol~     abuse or dependence. However, there are few studies using these models focusing on drug~     users. Although drug users are seen in large numbers in emergency departments, there have~     been no randomized controlled trials of SBIRT models for drug users presenting in Emergency~     Departments (EDs).~      This study is designed to assess the effects of Assessment, Referral, and a Brief~     Intervention on substance use of individuals screening positive for drug use during a~     medical ED visit. The Southwest Node of the NIDA Clinical Trials Network, located at UNM~     CASAA, is taking the lead on this study. Six sites across the country will participate in~     this study, including the ED of UNM Hospital. A total of 1285 ED patients who screen~     positive for current drug use problems will be randomly assigned to receive 1) minimal~     screening only, 2) assessment of substance use and referral to treatment, or 3) assessment~     and referral combined with a 30-minute counseling session (Brief Intervention) and two~     follow-up telephone counseling sessions. Outcomes will be assessed at 3, 6, and 12 months~     after the ED visit. We hypothesize that those who receive the Brief Intervention will have~     the least drug use at follow-up, that those who receive minimal screening only (the usual~     current practice) will have the most drug use, and that those receiving assessment and~     referral without the Brief intervention will have intermediate outcomes.~   "
141115|NCT01207778|"~     Approximately 60,000 premature infants are born each year who weigh less than 1,500~     grams,many of whom sustain brain damage because of their prematurity. This study is designed~     to evaluate the long-term developmental effects of one promising neuroprotective~     treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed~     neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether~     this is an effective treatment to prevent brain injury associated with prematurity, and to~     lay the groundwork for further studies to improve the developmental outcome of infants~     delivered prematurely.~   "
141116|NCT01207765|"~     The study involves the use of a targeted form of radiation, in addition to standard high~     dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted~     radiation is designed to kill more multiple myeloma cells while avoiding the side effects of~     standard radiation. This type of targeted radiation (also known as radioimmunotherapy) has~     been approved by the Food and Drug Administration (FDA) for the treatment of a related~     disease, lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose~     chemotherapy and stem cell transplants for patients with lymphoma and is now being studied~     in this clinical trial for patients with multiple myeloma. This trial is only available at~     Tufts Medical Center.~      The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe~     and effective when integrated into a standard regimen of myeloablative chemotherapy and~     autologous stem cell rescue in patients with measurable disease prior to high dose~     chemotherapy and autologous stem cell transplant for multiple myeloma.~   "
141117|NCT01207752|"~     The aim of this study will be to determine the efficacy of this novel, lipid-containing~     artificial tear on the signs and symptoms of meibomian gland disease.~   "
141118|NCT01207739|"~     The purpose of the study is to establish whether prolonged antibiotic treatment of patients~     diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines)~     leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO~     guidelines.~   "
141119|NCT01207726|"~     This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor,~     5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat~     (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung~     cancer (NCSLC).~   "
141120|NCT01207713|"~     To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end~     suturing surgical technique in hydroxyapatite orbital implants~   "
141121|NCT01207700|"~     This is a randomized, open trial comparing post discharge interventions by community health~     workers (CHW) to standard care in acute coronary syndrome (ACS) patients.~      This trial will be conducted in 10 hospitals in India/different parts(both secondary and~     tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD~     interventions and control groups (usual care)~   "
141122|NCT01207687|"~     People who have neurofibromatosis type 2 (NF2) can have tumors that grow on the auditory~     nerves and cause hearing loss. These tumors are called vestibular schwannomas (VSs), or~     acoustic neuromas. People with NF2 can also get schwannomas in other parts of their body, as~     well as tumors called meningiomas and ependymomas. Because VSs can cause hearing loss, many~     people with NF2 will have treatment to preserve their hearing. This treatment usually~     involves surgery. Because surgery has risks and is not able to help everyone with VSs, other~     methods of treatment are being explored. One area of exploration is looking to see if there~     is a drug that can be taken that might prevent the VSs from growing larger and causing~     hearing loss or brainstem compression. This study is exploring whether a drug that is~     approved by the FDA and is currently used to treat other tumors might also work to treat~     VSs. Based on people who have taken this drug to treat VSs already, there is some reason to~     think that it might be helpful to certain people with NF2. People enrolled in this study~     will receive the drug one time every three weeks for one year by infusion. This study will~     follow subjects over the course of the year that the person is taking the drug and for six~     months after the drug is stopped. This study is recruiting people who have NF2 and are~     currently having symptoms of tinnitus, dizziness, and/or hearing loss from their VSs. If you~     have NF2 and are currently having symptoms caused by your VSs, you may be eligible to~     participate.~   "
141123|NCT01207674|"~     This study is divided into two stages. The first stage is a transversal study and~     corresponds to the recruitment of participants, which will last about two years. Three~     groups of gamblers will be constituted : Non-problematic gamblers (NPG), Problematic~     gamblers Not in Care (PGNC) and Problematic gamblers in Care (PGC).The second stage is a~     prospective 5-year follow-up study of the cohort (only the initial NPG and PGNC groups are~     concerned by the follow-up study), that consists on an annual follow-up evaluation. The main~     objective of the first stage of the study is to compare the characteristics of the three~     groups of gamblers on some socio-demographic and clinical data. These comparisons will allow~     us to identify, among all data, those that will be most likely to explain the evolution of~     the practice of gambling (appearance or resolution of a gambling problem), and recourse to~     specific care. These such isolated data will be tested in the second stage of the study, in~     order to determine those that are predictive factors of three steps of the gambling course~     of some gamblers : evolution of a controlled gambling practice into a problematic gambling~     practice, resolution of the problematic gambling practice without intervention of care, and~     first recourse to specific care.~   "
141124|NCT01207661|"~     Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in~     terms of social and economic, are palliative and do not contemplate healing by regenerative~     therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in~     vitro and may regenerate several damaged or injured tissues. In addition its has~     demonstrated that MSC are able to modulate immune responses and to control inflammation~     through its action on T lymphocytes. Preliminary studies in animal models, including one~     carried out in an equine by the investigators research group, confirms feasibility, safety~     and efficacy evidence proposed treatment protocol.This study is designed to evaluate~     therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis~     clinical manifestations.This study is designed to evaluate therapeutic potential and safety~     of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.~   "
141125|NCT01207648|"~     The aim of this retrospective study is to review and describe safety, tolerability and~     efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents,~     using information already recorded in medical records. The study duration is 13 July 2010~     (first data collected) to 13 July 2011 (last data collected). In this study, Data of the~     subjects evaluated between 1997 and 2009 was observed.~   "
141126|NCT01207635|"~     The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage~     fluids of Breast Cancer patients.~      Breast cancer is the leading cause of cancer incidence and the second leading cause of~     cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of~     developing breast cancer.~   "
141127|NCT01207557|"~     The purpose of this study is to determine whether, among healthcare personnel who are~     undecided about whether to receive influenza vaccine, does use of the OIDA increase or~     decrease their confidence in their decision to be immunized? Furthermore, does the use of~     the OIDA affect the intent of the healthcare personnel to be immunized or not immunized?~   "
141128|NCT01207544|"~     Children with developmental coordination disorder (DCD) often have poor postural control and~     motor skills that affect their activities of daily living and participation in school~     activities. The aim of this randomized controlled trial is to compare the effects of fitball~     training versus task-oriented motor training for children with DCD.~   "
141129|NCT01207531|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which~     regulate mRNA expression. The present study was designed to screen several miRNA by~     microarray which evaluate the sepsis prognosis in order to be a new target for the treatment~     of sepsis.~   "
141130|NCT01207518|"~     During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will~     recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual~     or to use the Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide~     for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign~     season we will evaluate the impact of the Guide and web-based tools and assess whether there~     were changes in immunization rates within each organization and/or if there were significant~     changes in the management of the campaigns across organizations.~      Following completion of the study, we will work with partner organizations to make these~     tools available to all Canadian healthcare organizations.~   "
141131|NCT01207505|"~     Psychoeducation has been the only group treatment developed for bipolar disorder thus far.~     Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are~     not directly addressed in this treatment. The objective of this study is to develop a group~     treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing~     Emotion Regulation; EER). This study will examine the efficacy of this treatment using an~     open trial design. It is hypothesized that patients who receive EER will show a reduction in~     mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties~     will predict improvements.~   "
141132|NCT01207492|"~     Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia.~     Nilotinib works by blocking the action of a protein that might be important for the growth~     of pigmented villonodular synovitis (PVNS). In this research study the investigators are~     testing whether nilotinib can stop the growth of PVNS or improve the symptoms experienced~     from PVNS.~   "
141133|NCT01207479|"~     This is a non-randomized, open-label, multi-center clinical study to be conducted at~     approximately 5 investigative sites in the US that have expertise in the healthcare~     management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current~     moldable users while the remaining users can be non-moldable users if moldable users can not~     be enrolled.~   "
141134|NCT01207466|"~     The purpose of this trial is to compare the performance of two contact lenses for contact~     lens wearers with astigmatism.~   "
141198|NCT01206634|"~     The objective is to assess the effectiveness of regenerative injection therapy (RIT) to~     relieve pain and restore function in patients with knee osteoarthritis.~      The study design is a randomized controlled trial with cross-over. 40 patients with chronic~     knee osteoarthritis will be randomly assigned to receive exercise therapy for 32 weeks in~     combination with RIT on weeks 0, 4, 8, and 12 or exercise therapy for 32 weeks combined to~     RIT on weeks 20, 24, 28 and 32. The primary outcome is the WOMAC score.~   "
141135|NCT01207453|"~     The purpose of this study is to determine whether milnacipran reduces widespread, non-joint~     pain in patients with rheumatoid arthritis (RA). The investigators will conduct a~     double-blind randomized crossover trial in subjects with RA to test the hypothesis that~     milnacipran improves widespread, non-joint pain. The investigators will also use data from~     the trial to determine whether response to milnacipran is associated with pain-modulating~     mechanisms from the central nervous system. The investigators hypothesize that response to~     milnacipran will be greater among patients with impaired central pain mechanisms than among~     patients with intact central pain modulating mechanisms.~   "
141136|NCT01207440|"~     The purpose of this study is to determine the efficacy of ponatinib in patients with chronic~     myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or~     with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or~     intolerant to either dasatinib or nilotinib, or have the T315I mutation.~   "
141137|NCT01207427|"~     Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and~     reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI~     tract. The most common symptoms associated with the effects of opioids are constipation and~     nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of~     long-term opioid therapy.~      The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo~     in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid~     therapy for chronic noncancer pain.~   "
141138|NCT01207414|"~     Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult~     subjects with schizophrenia who require a change in their current antipsychotic treatment of~     risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or~     safety/tolerability reasons.~   "
141139|NCT01207401|"~     The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine~     administered prior to IUD insertion reduces insertion pain. The hypothesis is that women~     receiving paracervical analgesia will experience less pain during IUD insertion than those~     who do not receive such analgesia.~   "
141140|NCT01207388|"~     The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab~     (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal~     residual disease.~   "
141141|NCT01207375|"~     The current study is a double-blind, placebo-control randomized clinical trial examining the~     efficacy of memory retraining in Traumatic Brain Injury (TBI). Impairment in higher level~     cognitive processing, such as new learning and memory, is one of the most common deficits in~     individuals with TBI and such deficits have been shown to exert significant negative impact~     on multiple aspects of everyday life, including occupational and social functioning. Despite~     these findings, few studies have attempted to treat these cognitive deficits in order to~     improve the everyday functioning of individuals with TBI. The current proposal will evaluate~     (a)the efficacy of this treatment protocol within a TBI population,(b) the impact of the~     treatment on everyday functioning, (c) the long term efficacy of the treatment and (c) the~     utility of booster sessions in facilitating long-term treatment effects. The investigators~     will randomly assign individuals with TBI, with documented impairment in new learning~     abilities, to a memory retraining group or a placebo control group. Both groups will undergo~     baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional~     neuropsychological battery and (2) an assessment of global functioning examining the impact~     of the treatment on daily activities. This design will allow us to evaluate the efficacy of~     this particular memory retraining technique in a TBI population through the assessment of~     cognitive function via a standard evaluation. In addition, the investigators will be able to~     draw conclusions regarding the impact of this particular memory remediation program on~     everyday life from questionnaires completed by the participant and a significant other.~     Optional enrollment in pre/post neuroimaging will also allow us to look at changes in the~     brain.~   "
141142|NCT01207362|"~     The purpose of this study is to compare current standing balance assessment methods to a new~     method that measures weight shift during small movements of a sliding platform. It will also~     be used to determine if balance improves with repeated exposure as part of a 4-week training~     program.~   "
141143|NCT01207349|"~     Three hundred and ninety height diabetic patients were educated during a week of~     hospitalisation (nutritional and physical-activity advices). After that, they were~     randomized in two groups : frequent follow-up (each three month) by educational nurses and~     dieteticians, versus no follow-up (control group). All patients were evaluated one year~     after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk~     factors, nutritionnal and physical-activity behaviours.~   "
141144|NCT01207336|"~     Recent work showed that application of peripheral nerve and cortical stimulation~     independently can induce 10-15 % improvement in motor performance in patients with chronic~     stroke.~      The purpose of this study was to compare in post-stroke hemiplegic patients the effect on~     motor recovery of one session of anodal transcranial direct current stimulation to the~     ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical~     stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the~     same peripheral nerve stimulation combined with sham tDCS.~      Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for~     the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary~     outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability~     of Ipsilesional M1(TMS) Follow-up: 30 days~   "
141145|NCT01207323|"~     This is a Phase I, multicenter, open-label study of MEHD7945A in patients with incurable,~     locally advanced, or metastatic epithelial malignancies that have progressed despite~     standard therapy or for which no standard therapy exists.~   "
141146|NCT01207310|"~     The proposed study tests the efficacy of using pager-assisted messages combined with~     nicotine patches in facilitating smoking cessation and relapse prevention in a 2-arm~     randomized clinical trial. The hypothesis is that the proportion of biochemically-verified~     quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on~     alphanumeric pagers for 3 months along with individual smoking cessation counseling and~     nicotine patches will be greater that the proportion of biochemically-verified quitters who~     receive only individual smoking cessation counseling and nicotine patches.~   "
141147|NCT01207297|"~     In this comparative open-label cohort study, the investigators compared the efficacy and~     safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse~     proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus~     nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal~     function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.~      Methods: Forty patients with diffuse proliferative or membranous were recruited for this~     trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine~     (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the~     efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC~     group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone~     followed by azathioprine (50mg/day）for 6 months (CYC group).~   "
141148|NCT01207284|"~     The hypothesis is that a physical therapy intervention for foot and ankle of diabetic~     neuropathic individuals would affect positively the way they walk, lowering the harmful~     forces that these segments receive, that are associated mainly with lower range of movement,~     muscle weakness and loss of sensation. The participants will be randomly assigned into~     control group (regular treatment prescribed by their medical group) or into treatment group,~     that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes~     each session. This will aim for increasing foot and ankle range of movement, muscle strength~     and improving sensory inputs.~   "
141149|NCT01207271|"~     The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic~     psychotherapy, with cognitive therapy for the treatment of depression in community mental~     health consumers.~      Hypothesized mediators of treatment will also be examined.~   "
141150|NCT01207258|"~     This study is a randomized controlled trial of a brief intervention for women Emergency~     Department patients with involvement in both Intimate Partner Violence (IPV) and problem~     drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The~     study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief~     motivational intervention, delivered by social workers in the Emergency Department setting,~     in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with~     resources. Social work graduate students and/or staff will be trained to provide brief~     motivational enhancement therapy (MET) intervention for decreasing heavy drinking and~     IPV-related injury in women Emergency Department patients.~   "
141151|NCT01207245|"~     Cystic fibrosis is the most common inherited life limiting condition which affects children.~     Patients with it develop lung infections which become difficult to clear, and damage the~     lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed~     intravenous antibiotics). This has without doubt improved survival. However, all~     treatments have side effects. Tobramycin can cause kidney damage. The investigators have~     preliminary data that suggests that administering tobramycin in the morning may be safer for~     the kidneys than administering it in the evening.~      The investigators plan to approach children and adults with cystic fibrosis whose doctors~     have decided to administer a course of intravenous tobramycin. The investigators will~     randomly allocate them to receive it at either 0800h or 2200h. The investigators will~     measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring~     the amount of tobramycin in the blood stream after administering the antibiotic. For each~     patient the study will last for the duration of the course of antibiotics. This is decided~     by the doctor looking after the patient (rather than the researcher), and would typically be~     14 days. The investigators will also measure substances in the blood and urine~     (biomarkers) which are sensitive indicators of low levels of kidney injury. The~     investigators will monitor lung function and lung bacteria in both the groups to ensure that~     the patients in both groups improve by the same amount.~      If the preliminary data are proved correct, this research will allow investigators to~     improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic~     fibrosis.~   "
141152|NCT01207232|"~     The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost~     planning intervention could increase influence vaccination rates.~   "
141153|NCT01207219|"~     The current study aims to evaluate the impacts of yoga and aerobic exercise on~     neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120~     female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders~     within the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic~     exercise, and 3) waitlist group as the control. All groups will try to be kept consistent~     with their medication with no more than 25% change in their entry level dosage for at least~     six weeks. The primary outcomes of the present study will be neuro-cognitive changes; the~     secondary outcomes will be changes of brain structure and function.~   "
141154|NCT01207206|"~     In the current research the investigators would like to examine the effect of a well~     acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations.~     Usually the ketamine is given into the vein and not orally. The investigators want to give~     it orally to cancer patients that sufffer from severe pain to find out whether it can prove~     their quality of life, lower their pain and reduce the amount of opioids they receive.~   "
141155|NCT01207193|"~     There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone,~     but they are most commonly seen in children and young adults while their bones are still~     growing. Living with a bone cyst and determining treatment options depend on the type of~     cyst.~      Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals~     who do not experience any symptoms.~      Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or~     the area of the bone starts to thin out. The investigators aim to assess the clinical~     efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone~     cyst.~   "
141156|NCT01207180|"~     The investigators hypothesize that the acquisition and correct utilization of medications as~     well as arranging and attending follow-up appointments will improve as a result of a phone~     call intervention 1-3 days after elderly patients are discharged from the emergency~     department (ED).~   "
141379|NCT01204255|"~     RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into~     the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial~     studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.~   "
141157|NCT01207167|"~     South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high~     rates of cardiovascular disease that is not explained by traditional cardiovascular risk~     factors. Though South Asians represent over one-quarter of the world's population, there are~     no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a~     longitudinal study of South Asians at two United States centers to identify risk factors~     linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of~     this study is to understand the causes of heart disease and stroke in South Asians and~     compare these causes to those in other United States ethnic groups.~   "
141158|NCT01207154|"~     The purpose of this study is to determine whether or not a device which measures depth of~     anaesthesia and sedation can be used to assist in the sedation of patients who must have~     breathing tubes positioned in their airways before general anaesthesia~   "
141159|NCT01207141|"~     This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and~     early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization~     after induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in~     children and adults with pediatric liver transplantation. Eighty subjects (0-21 years)~     receiving liver transplantation will be enrolled. Incidence and severity of biopsy-proven~     acute cellular rejection (ACR) is a primary endpoint as well as time to Tacrolimus whole~     blood concentrations <8 ng/ml The expected incidence of ACR is 50% and is derived from a~     non-consecutive subject population (n=40) who received an identical regimen in IND 64555.~     This incidence is acceptable because the long term sequel of rejection reported with other~     allografts have not been observed in liver grafts during IND 64555. These risks are further~     negated by the unique regenerative capacity of the liver allograft. An OBSERVATIONAL arm is~     being included in this trial. Because the numbers of pediatric liver transplants (LTx) are~     small in any single center setting, no information is known about relative outcomes on a~     conventional protocol, in children receiving conventional protocol of steroids+Tacrolimus.~     The PURPOSE of this additional recruitment is OBSERVATIONAL, only. Therefore, these subjects~     will NOT be randomized. Rather, by studying all types of patients, the investigators hope to~     utilize maximally, all available subjects, to understand the relative place of~     monotherapeutic induction. In turn, this will be the basis for a follow-up comparative,~     randomized trial.~   "
141160|NCT01207128|"~     The purpose of this study is to evaluate the therapeutic effectiveness of combination~     antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo~     equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological~     cancer.~   "
141161|NCT01207115|"~     To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to~     placebo in subjects with osteoarthritis (OA) of the knee.~   "
141162|NCT01207102|"~     Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®~     (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy~     and tolerability. When combined with a taxane, platinum agents improve response in~     metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. The~     investigators hypothesize that the combination of weekly Abraxane® and carboplatin will~     lengthen time to progression without producing intolerable toxicity.~   "
141163|NCT01207089|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of AZD8329 following multiple ascending dose administrations in in~     overweight to obese but otherwise healthy male subjects.~   "
141164|NCT01207076|"~     This study is a single institution phase I study for the treatment of patients with relapsed~     or refractory leukemia aged 12 years and older using 90Y-AHN-12.~   "
141165|NCT01207063|"~     The investigators group uses an individualised radiation dose approach in which the dose is~     escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is~     69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with~     an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose)~     constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the~     investigators will adapt the treatment by performing a new (PET)-CT at day 12 during~     radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be~     increased.~   "
141166|NCT01207050|"~     This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among~     individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both~     objective and subjective measures. It will also show that improvement in sleep/wake patterns~     resulting from Rozerem will impact daytime functioning using objective and subjective~     measures.~   "
141167|NCT01207037|"~     Acute splenic sequestration is a frequent and life threatening complication occurring in~     approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.~      The investigators formulate the hypothesis that there are clinical, biological and genetic~     markers predictive of severe complications notably acute splenic sequestration in SCD~     children. The present research project thus aims at analyzing in a forward-looking way the~     profile of severity by analysing clinical, biological and genetic characteristics in a~     multicentric cohort of 60 SCD children~   "
141168|NCT01207024|"~     Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal~     of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious~     sub-chondral bone) before and one year after bariatric surgery.~      Knee MRI is not currently part of the investigations preceding bariatric surgery.~   "
141169|NCT01207011|"~     The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the~     treatment of non-small cell lung cancer (NSCLC).~   "
141170|NCT01206998|"~     The purpose of this study is to compare how well vaginal progesterone works delaying the~     time to delivery in women with preterm labor compared to placebo. The study will also~     compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm~     delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and~     treated with medication to stop preterm labor.~   "
141380|NCT01204242|"~     The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given~     during anesthesia intravenously (IV) through a needle in your vein,), can:~        1. Help decrease pain after surgery.~        2. Have you need less pain medication.~        3. Have less side effects like nausea and vomiting following your surgery.~        4. Help to prevent chronic pain.~        5. Affect recurrence of cancer after surgery.~   "
141171|NCT01206985|"~     Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and~     pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous~     and rectal.~      The per-oral mucosal route is not used for the administration of paracetamol. It is a very~     interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris,~     as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows~     very rapid action. In addition, the oral administration-oral mucosa, less restrictive than~     IV administration and faster than oral administration, seek a single medical procedure~     unattended after dosing, will entail no pain or risk for infections the patient (in contrast~     to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of~     paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the~     only dosage form of reference used by the IV route in the protocol Pilot study Pharmacology~     paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by~     half permucosal to assess how changing the pharmacodynamics of the form permucosal to~     125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual~     (under the pillar of the language) and compared with paracetamol in IV.~   "
141172|NCT01206972|"~     The objective of this dose-confirmatory bridging study is to investigate the safety and~     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous~     thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR)~     and to confirm the extrapolability of global data to Japanese patients by comparing with~     data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.~   "
141173|NCT01206959|"~     The purpose of this study is to monitor the blood pressure level of the patient using a~     blood pressure monitor which test the blood pressure level in inflating state . The cuff~     range in the study is 22cm-48cm~   "
141174|NCT01206946|"~     The hypothesis of the study is that administration of antenatal steroid to women at high~     risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory~     complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of~     the Newborn (TTN) in late preterm babies.~   "
141175|NCT01206933|"~     Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and~     Molecular Biology of The George Washington University Medical Center are carrying out a~     research study to determine why patients with Human Immunodeficiency Virus (HIV) and~     Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of~     HCV infection, leading to fatty infiltration of the liver and cirrhosis.~   "
141176|NCT01206920|"~     The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that~     will describe clinical outcomes, and improve the quality of care for outpatients with Human~     Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.~   "
141177|NCT01206907|"~     The purpose of this study is to evaluate the effectiveness, tolerability, and safety of~     oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having~     severe to moderate chronic pain.~   "
141178|NCT01206894|"~     Non-Small Cell Lung Cancer (75% of lung cancer) is associated with involvement of the~     parietal pleura and or chest wall (soft tissue and/or bone) in 5-8% of patients. Invasion of~     the chest wall increases the T staging in the Tumor, Node, Mestasis (TNM) classification~     system of lung cancer to a T3 and is associated with decreased survival and more extensive~     operative procedures. The reported 5-year survival for patients with T2 tumors is 58%~     compared to 38% in patients with T3 lesions. The American college of Chest Physician has~     still not identified the best tool to assess chest wall invasion by lung cancer, CT-Scan~     being used by physicians for this assessment. In some studies, CT scan has been shown to~     have a sensitivity ranging from 42 % to 68 % in assessing chest wall invasion, and a~     specificity ranging from 66 % to 100 %.~      Trans-thoracic Ultrasound (US) has the capacity of allowing for dynamic real-time imaging of~     the pulmonary lesion and the chest wall. Therefore, US has the potential to allow for the~     appreciation of subtle findings related to the movement of the lesion and lung over the~     chest wall. Hence, US might be an accurate tool to assess chest wall invasion by lung~     cancer; thus improving pre-operative diagnosis, staging and operative planning of patient~     with chest wall invasion.~      However US is not currently utilized in the pre-operative assessment of patients with lung~     cancer invading the pleura and chest wall, and has not been extensively studied.~      In some rare studies evaluating the accuracy of US, results have shown a sensitivity ranging~     from 89% to 100% and a specificity ranging from 95% to 98% for US detecting chest wall~     invasion by lung cancer. However those studies got criticized. Bandi et al study, got~     criticized by the fact that the operators in the study were experienced interventional~     pulmonologists who perform hundreds of thoracic and endoscopic ultrasound per year. Nobuo et~     al study took place in 1993, since when the device of US has evolved, the investigators can~     not apply with certainty the findings of this study.~      Consequently, there is a need to conduct a study to evaluate the accuracy of US to assess~     chest wall invasion by lung cancer.~      In this prospective study the investigators will assess the accuracy of US, and then compare~     it to the accuracy of the CT-Scan~   "
141179|NCT01206881|"~     The purpose of this study is to determine the efficacy of neoadjuvant treatment with~     pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by~     docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary~     tumor > 5 cm.~   "
141180|NCT01206868|"~     A single centre open randomised parallel-group study to evaluate whether prophylactic~     fenestration of the peritoneum at the time of renal transplantation prevents lymphocele~     formation.~      Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for~     inclusion. From March 2007 to May 2009 130 patients were included. The patients were~     randomized either to peroperative peritoneal fenestration, or to serve as controls.~     Block-randomization was conducted in groups of 10, drawn from envelopes containing five~     notes from each group. Patients who previously had undergone extensive abdominal surgery, or~     were included in other studies were excluded.~   "
141181|NCT01206855|"~     A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic~     procedures(including facelifts, blepharoplasties, breast augmentations and reductions,~     mastopexies, and abdominoplasties) traditionally associated with pain, swelling, bruising,~     and scarring. The study will test the hypothesis that MIST Therapy can decrease the~     incidence and severity of these surgical sequelae throughout the acute and sub-acute phases~     of healing.~   "
141182|NCT01206842|"~     People with schizophrenia show deficits in social cognition, the ability to process~     information about other people such as identifying their emotional expressions. Social~     cognition is associated with everyday life functioning and could therefore be an important~     treatment target. Several social cognitive training programs have been developed during the~     last years. Results indicate that social cognitive performance can be ameliorated through~     commonly used intervention techniques. However, it is less clear whether this improvement~     generalizes to everyday life. The purpose of this study is to investigate if a social~     cognitive training program (Training in Affect Recognition) improves performance on social~     cognitive and neuropsychological tests and leads to improved everyday life functioning in~     persons with schizophrenia. The study also aims at examining if an improvement is present~     three months after completion of the training intervention.~   "
141183|NCT01206829|"~     A randomized controlled study with hearing impaired workers, who have voluntarily signed up~     for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a~     waiting list control group. Participants who are allocated to the intervention group will be~     offered to start on the CBT-course immediately, while the control group that will be offered~     the same course 12 months later. Main outcome measures are assessments of mental distress~     and vocational coping. We will also assess the distress associated with tinnitus, which is a~     potential moderator variable.~   "
141184|NCT01206816|"~     The primary objective of the current study is to investigate the Maximum Tolerated Dose~     (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in~     patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992~     will be varied to establish the MTD of the combination. Two combination treatment schedules~     will be tested, the MTD of each combination will be determined.~      Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary~     efficacy.~   "
141185|NCT01206803|"~     The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian~     stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH),~     demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of~     gonadotropin receptors and secreted gonadotropins).~   "
141186|NCT01206790|"~     Posttraumatic stress disorder (PTSD) is associated with poor health, high health care~     utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune~     diseases. Research, including our own findings, indicates immunological alterations in PTSD~     patients. The aim of this study is to investigate whether alterations in the immune system~     of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative~     Exposure Therapy).~   "
141187|NCT01206777|"~     The purpose of this study is to assess the feasibility of a 60 minute rapid infusion~     rituximab protocol in the institution's outpatient infusion center.~   "
141188|NCT01206764|"~     Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over~     100,000 cancer deaths annually in the World (Ferlay, et al., 2004). It is estimated that~     there were about 15,000 new cases of RCC in the region that excludes the Americas, European~     Union and Japan. Renal cell carcinomas arise from the proximal tubal epithelium are more~     common in males than in females with an overall lifetime risk of 1 in 75 and a median age of~     diagnosis of 65 years.~      Everolimus (Certican®) has been approved since 2003 in more than 60 countries for the~     prevention of organ rejection in patients with renal and cardiac transplantation. Everolimus~     (RAD001) is a derivative of rapamycin, which acts as a signal transduction inhibitor. It~     targets mTOR, a key protein kinase regulating cell growth, proliferation, and survival. The~     mTOR pathway activity is modulated by the phosphatidylinositol-3-kinase (PI3K)/protein~     kinase B AKT (AKT) pathway, a pathway known to be deregulated in numerous human cancers.~     RAD001 (Afinitor®) has been investigated as an anticancer agent based on its potential to~     act:~        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation;~        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent~          inhibition of tumor cell hypoxia-inducible factor 1 (HIF-1) activity, VEGF production,~          and VEGF-induced proliferation of endothelial cells).~      Primary: To evaluate the PFS rate over time.~      Secondary:~        -  To evaluate the disease control rate (stable disease [SD] + partial response [PR] +~          complete response [CR]);~        -  To evaluate the objective response rate (ORR; where ORR = CR + PR) and duration;~        -  To describe the safety profile of RAD001.~   "
141189|NCT01206751|"~     Multi-detector computer tomography protocol project: Chest imaging technique and case~     presentation.~   "
141190|NCT01206738|"~     1. Do paper-based and web-based intervention modelling experiments (the methodology we are~          developing) identify the same predictors of GP behaviour regarding prescribing of~          antibiotics for upper respiratory tract infections?~        2. Can a web-based IME system provide trialists with richer and more predictive~          information upon which to base the development of behavioural change interventions than~          paper-based IME systems?~   "
141191|NCT01206725|"~     The aim of the study is to compare the effects of aerobic interval training and the IDF~     recommendations on physical activity on cardiac function and CV risk factors in patients~     with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction~     in patients with subclinical LV disease, improve both endothelial function and VO2max and~     thus reducing CV risk factors and CV disease. HbA1c will be more stable.~      The aims of this study are to address the exercise prescription recommendations for patients~     with (T2DM) who have subclinical heart disease. The prescription recommendations will be~     assessed by randomising T2DM patients with subclinical heart disease to one of the following~     2 groups for 3 months followed by a 9 month home-based program:~      Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise~     recommendations of the International Diabetes Federation.~      Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved~     through high-intensity interval training.~   "
141192|NCT01206712|"~     The purpose of this phase IV clinical trial is to investigate the effect of Insulin glargine~     + metformin treatment vs. sulfonylurea + metformin treatment vs. DPP-4 + metformin treatment~     vs. healthy volunteers on ß-cell function after the uptake of a standardized meal.~   "
141193|NCT01206699|"~     The specific aim of this study is to determine whether, when treated with corticoid~     infiltration, certain chronic lumbagos could be explained by the presence of a~     neo-articulation.The primary criteria is to determine the difference between the mean pain~     during the latest 24 hours preceding the infiltration and the mean pain preceding the visit~     S4 (visit 4 weeks after the infiltration)~   "
141194|NCT01206686|"~     The goal of this project is to see if encouraging an individual to privately choose in~     advance a narrow time window in which to obtain a flu vaccination shot affects the~     likelihood that he or she will become vaccinated.~   "
141195|NCT01206673|"~     The aim of this study is to evaluate macrophaging activity and immunologic profile of~     patients with Gaucher 's disease. For this, one blood sampling will be performed.~   "
141196|NCT01206660|"~     The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is~     effective for the treatment of patients with moderate to severe plaque psoriasis.~   "
141197|NCT01206647|"~     The purpose of this study is to investigate the success rate of a switch from insulin~     therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus.~   "
141199|NCT01206621|"~     For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF~     causes is essential for proper management. The capacity to triage patients quickly and~     accurately has a beneficial impact upon outcome, disposition, stratification and length of~     stay in the ED and required length of hospital admission.~      The ability to assess pulmonary status rapidly by quantitative regional vibration technology~     offers significant potential advantage for earlier diagnosis. The VRI technique may provide~     a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to~     pulmonary causes; thereby improving management and outcomes.~   "
141200|NCT01206608|"~     The primary objective of this study was to demonstrate the superiority of SKY0402 over~     conventional, commercially-available bupivacaine HCl with respect to the duration of the~     analgesic effect achieved by a single local administration of the study drug.~   "
141201|NCT01206595|"~     The primary objective of this study was to determine the appropriate dose of SKY0402~     administered as a nerve block for the management of postoperative pain following~     bunionectomy.~   "
141202|NCT01206582|"~     This study is designed to learn if hemin can increase the production of heme oxygenase 1 and~     improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric~     emptying (gastroparesis).~   "
141203|NCT01206569|"~     Glomerulonephritis is one of the major disease manifestations of systemic lupus~     erythematosus (SLE). Around one-third of the patients, however, do not respond to~     conventional immunosuppressive therapy, and they have a high risk of progressing to~     dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy~     targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be~     effective in the treatment of primary glomerulonephritis. The investigators plan to an~     open-label single-arm study the efficacy and safety of long-acting tacrolimus in the~     treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven~     lupus nephritis will be recruited. They will be treated with oral prednisolone and~     long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and~     azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be~     monitored. This study will explore the potential role of long-acting tacrolimus in resistant~     lupus nephritis, which has a poor prognosis and no effective treatment at the moment.~   "
141204|NCT01206556|"~     This study is being done to evaluate how long the immune response from the Human Papilloma~     Virus (HPV) vaccine you / your child received persists. The immune response occurred after~     immunization and is what protects you/your child from HPV disease. You / your child received~     this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus~     Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the~     protective effects (called antibodies) produced by the vaccine have lasted, and for how~     long these effects will continue to last. You will not be given any medications or vaccines~     as part of this follow-up study.~   "
141205|NCT01206543|"~     Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in~     craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.~   "
141206|NCT01206530|"~     In this Phase I/II clinical trial, the investigators seek to pilot the addition of~     hydroxychloroquine (HCQ) to the standard front-line therapy of colorectal cancer,~     FOLFOX/bevacizumab. In toxicity terms, the investigators previous studies lead them to~     believe that a full dose (800mg) of HCQ will be well-tolerated in this setting. By starting~     at 600 mg, the investigators will ensure that the full dose is approached with an eye to~     safety, and if needed, the investigators will use the lower dose. Both doses achieve~     autophagy inhibition in our current studies.~   "
141207|NCT01206517|"~     This study is an open label, sequential-group, two site, multiple dose escalating study of~     sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I~     disorder; in one study cohort (3a) participants with other conditions treatable with chronic~     antipsychotic medication can also be enrolled. Participants will receive a single sublingual~     placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily~     (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a~     final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12~     (Cohort 3a).~   "
141208|NCT01206504|"~     This study will test an experimental drug called MGAWN1 for the treatment of West Nile~     infections.~   "
141209|NCT01206491|"~     Department of Chronic Disease and Health Promotion of World Health Organization listed eight~     classes of chronic disease which will be important globally in the future. And the sixth~     class is Chronic Rheumatic Condition, which includes rheumatic arthritis, osteoarthritis,~     osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a~     globally important health topic.~      Osteoporosis draws more and more attention, because osteoporosis has various influences, for~     example, (1) psychologically impact which occurs frequently in many chronic diseases, such~     as depression will appear evidently in patients with osteoporosis (2) patients with~     osteoporosis often lose their social role (3) osteoporosis might induce pain and limitation~     of body function (4) osteoporosis increases greatly the possibility of fracture.~     Osteoporosis will induce adverse outcomes, such as the fall of life quality, the increase of~     morbidity and mortality, as well as the increased abuse of medical service. In this project,~     the investigators will set up the intervention model for prevention of osteoporosis as well~     as falls.~      In this project, the investigators will recruit patients form outpatient services at WanFang~     Hospital. Through the collection of baseline data from questionnaire and bone density~     measurement, the investigators can clarify the risk of osteoporosis and falls in studied~     patients. By using double-blind randomized design, the patients will be collected to either~     one of intervention and control group. After eight weeks of intervention programs, the~     investigators will follow on both groups to understand the effect of this program and to~     increase the bone density of intervention group. The hospital or the Health center might~     take the outcome to be the reference of taking care the Osteoporosis.~   "
141236|NCT01206140|"~     This randomized phase II trial is studying how well giving selumetinib together with or~     without temsirolimus works in treating patients with metastatic, recurrent, or locally~     advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     It is not yet known whether giving selumetinib together with temsirolimus is more effective~     than giving selumetinib alone.~   "
141210|NCT01206478|"~     Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or~     are unable to eat enough to have normal growth. Although often intended as temporary~     short-term solutions to medical complications, feeding tubes can become a permanent method~     for eating.~      While tube feeding routinely saves the lives of children who have long term food refusal,~     continuation of tube feeding can be hard for patients, caregivers, and families. At the~     current time there are few treatments for helping children move from tube to oral feeding.~     Some patients may be treated with the help of inpatient programs such as a combination of~     medical and behavioral techniques to train children to eat orally. These programs typically~     require hospital stays of 2-4 months.~      By doing the current study the investigators hope to learn if the investigational drug~     amitriptyline is helpful in moving children from tube to oral feeding, and to look at~     whether or not the treatment of pain helps with this transition.~   "
141211|NCT01206465|"~     RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when~     given together with fluorouracil in treating patients with recurrent solid tumors~   "
141212|NCT01206452|"~     The primary purpose of this study is to assess the efficacy of oral prednisone in improving~     the outcomes of pulmonary vein isolation with radiofrequency ablation.~   "
141213|NCT01206439|"~     The purpose of this study is to determine if Nebivolol has any effect on heart function~     determined by changes in echocardiographic data or exercise tolerance.~   "
141214|NCT01206426|"~     This is observational clinical trial to study adult urothelial cancer patients treated with~     cisplatin‐based neoadjuvant chemotherapy.~      Hypothesis: Identification of genetic and molecular cisplatin susceptibility biomarkers~     will allow identification of urothelial cancer patients most likely to benefit from~     cisplatin‐based neoadjuvant chemotherapy.~   "
141215|NCT01206413|"~     The study investigated the effectiveness of home-based exercise combined with a slight~     caloric restriction on weight change during 12 months in non-obese women. In addition the~     investigators evaluate the effects of baseline insulin resistance on modulation of weight~     change.~      A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two~     hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned~     to one of two groups: control (CG) and home-based exercise (HB). The HB group received a~     booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session),~     in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed~     at a slight energy restriction of 100-300 calories per day.~      The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04),~     but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the~     serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12~     of 18.3 mg/dl in the HB compared to 9.5 in the CG (p<0.01). At baseline the non-IR group~     (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but~     statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected.~     When the group non-IR and IR were further stratified by GI diet, there were no differences~     according to diet in both groups. Women classified as IR at baseline had greater weight loss~     after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to~     reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed~     between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no~     differences between IR and NIR groups for lipid profile after adjustment for weight changes.~     During follow-up, changes were more pronounced among those women in the high GI diet. These~     differences were statistically significant for weight and BMI and were greater among the IR~     compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different~     comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the~     non-IR this value increased (-0.73 vs. +0.37; p=<0.001). Also this reduction was greater~     among high compared to low GI diet (p=0.04).~   "
141216|NCT01206400|"~     To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with~     type 2 diabetes mellitus.~   "
141217|NCT01206387|"~     The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is~     effective for the treatment of patients with moderate to severe plaque psoriasis.~   "
141218|NCT01206374|"~     Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin,~     hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that~     are thought to be required for development of vitiligo, only 5-10% of relatives develop~     disease. The triggers for disease onset have not yet been identified. The intent of this~     study is to research trends in laboratory data, social and medical history that may be~     contributory to vitiligo onset, location of disease, course of illness and response to~     therapy.~   "
141219|NCT01206361|"~     The hypothesis is that there is no difference in persistency between Xalacom and the~     alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.~   "
141220|NCT01206348|"~     To determine if a combination of three currently approved acne products are safe and~     effective for the treatment of moderate to severe acne~   "
141221|NCT01206335|"~     The purpose of this study is to determine whether patients with advanced cancers who receive~     OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life.~     Based on a previous study in patients with AIDS, possible benefits may include improved~     appetite and strength; weight gain, improved mood; and decreased fatigue.~   "
141222|NCT01206322|"~     Our goal is to determine the acute effects of intranasal insulin on regional perfusion and~     cognition of older adults. We propose a pilot study to examine the effect of a single dose~     of intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with~     T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled,~     cross-over design.~      Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in~     older patients with T2DM as compared with placebo and compared with the control group.~      Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory~     and executive function in diabetic patients as compared with placebo and compared with~     control group.~   "
141223|NCT01206309|"~     The purpose of this research study is to better understand the onset and course of graft~     versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.~   "
141237|NCT01206127|"~     Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by~     donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part~     (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping~     Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea~     is replaced.~      The purpose of this study is to investigate how immediate postoperative positioning of the~     patient affects the dislocation rate of the corneal graft. Since this is a new surgical~     method, little scientific documentation has been published in this area.~   "
141224|NCT01206296|"~     This is a phase II study evaluating the use of intraperitoneal gemcitabine given~     intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.~      The primary objective of this study is to evaluate the overall safety of intraperitoneal~     gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable~     pancreatic adenocarcinoma.~      The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected~     in overall survival at 2-years, to study the patterns of disease recurrence following this~     treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in~     peritoneal cytology with pancreatic cancer resection.~   "
141225|NCT01206283|"~     Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage~     (SAH) and severe traumatic brain injury (TBI). The current management strategies are based~     on intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis~     monitoring (modified Lund concept) or cerebral perfusion pressure-targeted therapy~     (CPP-targeted). We present a randomised controlled study to compare the two management~     strategies.~      The hypotheses of the study were:~        -  SBI developed after aneurysmal SAH and severe TBI share the same crucial~          characteristics and any treatment applied will essentially treat the same underlying~          pathophysiology.~        -  ICP-targeted therapy with cerebral microdialysis monitoring according to the modified~          Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI~          after aneurysmal SAH and severe TBI.~      Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were~     randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted~     therapy groups. Mortality rates in both groups were calculated and biochemical signs of~     cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral~     microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good~     outcome (Glasgow Outcome Scale score 4 and 5).~   "
141226|NCT01206270|"~     Patients with infertility often presents alterations at ultrasonographic examination of the~     testis. These alterations include a much higher incidence of small, multiple, non-palpable~     hypoechoic micro-nodules that can show internal vascularization. This finding often create~     alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage~     malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent~     number of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours.~     The purpose of this study is to evaluate the effects of androgen therapy on the size and~     number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin~     levels.~   "
141227|NCT01206257|"~     This study is to collect the information of Ultravist® in the patients indicated for the~     coronary angiography or PCI, like rate of ADR in patients, the dose for different~     indications, image quality to prove Ultravist the good safety and effectivity~   "
141228|NCT01206244|"~     This study is to determine the diurnal variation of tear meniscus and tear osmolarity in~     normal subjects and dry eye patients.~   "
141229|NCT01206231|"~     This study is aimed to collect the following Serbia-specific epidemiology data on~     hypercholesterolemia: patents characteristics, patients' management/treatment and~     physicians' standard practice. In addition, the aim is to determine the proportion of~     patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C~     treatment goals.~   "
141230|NCT01206218|"~     Evaluation of customized treatment according to BRCA1 assessment in patients with advanced~     gastric cancer~   "
141231|NCT01206205|"~     The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with~     bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This~     study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone~     will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and~     after High Dose Therapy (HDT) with ASCT.~   "
141232|NCT01206192|"~     The purpose of this study is to extend the extant work on the typology of intimate partner~     violence (IPV) by employing mixed methods to collect quantitative and qualitative data.~   "
141233|NCT01206179|"~     Treatment of nonunion, delayed union and malunion fractures of long bones remains~     problematic. The definition of nonunion is a failure of the fracture to heal in six months~     in a patient in whom progressive repair had not been observed radiographically between the~     third and sixth month after the fracture. First of all good surgical techniques are stable~     immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is~     required. Numerous techniques have been developed ranging from invasive interventions~     (including internal fixation with the use of bone graft or bone graft substitutes) to non~     invasive procedures (ultrasound and pulsed electromagnetic fields).~      Recently, autologous cell therapy was presented as an interesting approach. The concept of~     such therapies is based on the effect of stem cells presented in the bone marrow and able to~     be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem~     cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce~     later surgeries required to augment the healing process and to accelerate the time to~     healing.~   "
141234|NCT01206166|"~     The specific aim of the proposed study is to conduct a pilot study involving 160~     critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of~     America, Belgium and France in order to:~      Specific Aims~        -  Confirm that we can achieve a clinically significant difference in calorie and protein~          intake between the two intervention groups.~        -  Estimate recruitment rate i.e. number of eligible and enrolled patients per month per~          site.~        -  Evaluate the safety, tolerance, and logistics around providing supplemental PN in the~          study population in the context of a multicenter trial, e.g.~             -  To ensure adequate glycemic control in both groups.~             -  To ensure that the other metabolic consequences of the feeding strategies are~               minimized.~             -  To establish adequate compliance with study protocols and completion of case~               report forms~      A secondary aim of this pilot study will be:~      • To explore the effect of differential effects of calorie and protein delivery on muscle~     and mass function.~   "
141235|NCT01206153|"~     Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The~     investigators conducted a randomized, placebo-controlled study to test the efficacy of~     metformin for antipsychotic induced amenorrhea in schizophrenia patients.~   "
141241|NCT01206075|"~     Thalassemia is considered the most common genetic disorder worldwide, occurring with high~     frequency in Mediterranean areas, the Middle East, Southeast Asia, and the Pacific Islands.~     Currently, the only cure for thalassemia is bone marrow transplantation from a related,~     compatible donor. Gene transfer, achieved by transplantation of the patient's own blood stem~     cells that have been genetically-modified with the corrected gene, could potentially cure~     thalassemia.~      The first step in developing gene transfer for treatment of thalassemia is to develop a safe~     and effective method to obtain blood stem cells from thalassemia patients. Eventually, high~     numbers of genetically modified cells will need to be infused into the patient for clinical~     gene transfer to be effective. The blood stem cells are obtained by giving a mobilization~     agent to the patients. This causes the stem cells to leave the bone marrow and go into the~     blood. The purpose of this study is to test the safety and effectiveness of the new~     mobilization agent, Mozobil, in causing mobilization of blood stem cells for patients with~     beta-thalassemia major.~   "
141242|NCT01206062|"~     Elevated blood pressure (BP) is an important public health concern. It is highly prevalent,~     the prevalence may be increasing, and it is a risk factor for several adverse health~     outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease,~     and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT)~     is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment~     program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently~     recommended will reduce cardiovascular disease (CVD) risk.~   "
141243|NCT01206049|"~     The purpose of this study is to determine the rate of progression free survival of patients~     with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are~     treated with combination chemotherapy supplemented by biological agents panitumumab or~     bevacizumab.~   "
141244|NCT01206036|"~     In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be~     shown before the study can be expanded into a Phase II study to examine the activity of a~     safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.~   "
141245|NCT01206023|"~     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic~     and environmental factors. Different populations have different susceptibility. The disease~     is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical~     disability is due to distraction of the CNS myelin.~      Repair processes are mainly noted after the acute attack - and recovery of function can be~     spontaneous. However, in severe attacks sometimes there is need for adding STEROID TREATMENT~     (6 days IV) for the acute attack.~      For the long term prophylactics - following the increased understanding of the disease, in~     the last 10-15 years there are new immunotherapies available (COPAXON / TEVA; Interferon~     -beta). However these can attenuate the disease (reduce the number of relapses per year) but~     are not cure. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.~      Currently there are no biomarkers available for MS (other than oligoclonal IgG in the CSF -~     which help confirm diagnosis but require invasive procedure and are not correlated with~     disease activity nor response to therapy) and - monitoring of MS and its treatment is by MRI~     - which is expensive.~      Dr Hossam Haick from the Technion developed an electronic nose based nanomaterials for~     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research~     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair~     can be detected by electronic nose.~   "
141246|NCT01206010|"~     Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors.~     It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of~     cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions~     (primarily nausea) in sensitive clients. The downside of this cautious approach is that a~     substantial proportion of clients may be under-dosed. A blanket dose increase would~     inevitably increase the incidence of side effects, but it is likely that tailoring~     varenicline dosing to clients' needs would be safe and may further increase varenicline's~     efficacy.~      This study will recruit 200 smokers who report little change to their enjoyment of~     cigarettes and no nausea, during the first week of varenicline use. These smokers will be~     randomised to receive the standard dose plus placebo or plus individualised varenicline dose~     up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and~     other withdrawal symptoms, experienced during the study period will be compared between~     groups to see if the tailored therapy may be useful.~   "
141247|NCT01205997|"~     Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce~     preemptive analgesia when administrated before tissue injury , thus decreasing the~     subsequent sensation of pain.~      Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr~     old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were~     studied in a prospective, double-blinded, randomized way. The patients were randomly~     allocated to one of three groups of 30 each. The magnesium group (groupM) received~     bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received~     bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P)~     received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first~     requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset~     of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension,~     ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90],~     postoperative analgesic requirements and Adverse events, such as sedation, dizziness ,~     Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed~     preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum~     imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a~     supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain~     relief as needed .~   "
141337|NCT01204892|"~     The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus~     Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local~     infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic~     cholecystectomy.~      Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce~     postoperative pain scores when compared to conventional postoperative pain control with~     local infiltration of trochar insertion sites.~   "
141248|NCT01205984|"~     The place of systemic corticosteroids in the treatment of children with chronic~     rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability~     of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in~     children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS~     were included. Patients were randomly assigned to either oral amoxicillin/clavulanate~     (AMX/C) and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered~     for the first 15 days with a tapering schedule. Primary parameters were mean change in~     symptom and sinus computed tomography (CT) scan scores after treatment. Secondary study~     parameters were mean changes in individual symptom scores after treatment, relapse rate and~     tolerability. Forty-five patients completed the study, 22 received AMX/C and MP, and 23~     AMX/C and P. Both groups demonstrated significant improvements in symptom and sinus CT~     scores, comparing baseline to end of the treatment (p<0.001). Methylprednisolone as an~     adjunct was significantly more effective than placebo in reducing CT scores (p=0.004), total~     rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001),~     postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the~     children in the P group still had abnormal findings in CT versus 14% in the MP group (p =~     0.013). Therapy-related adverse events were not different between groups. Although~     insignificant, the incidence of clinical relapses was also less in the MP group (25%)~     compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit~     to treatment with antibiotics for children with CRS.~   "
141249|NCT01205971|"~     Dental caries is the most common chronic disease of childhood and is increasing in~     prevalence in children 2-5 years old. Racial and ethnic minority groups as well as~     economically disadvantaged individuals are affected the most by this health outcome. This~     study will test if a community-based multimodal intervention will reduce 2-year incidence of~     early childhood caries (ECC) in children aged 0-5 living in public housing developments. The~     intervention combines the components of motivational interviewing (counseling) delivered by~     dental health advocates, fluoride varnish application, oral health assessment and referral.~     The investigators hypothesize that the multimodal intervention with motivational~     interviewing will reduce ECC behavioral risk factors thereby leading to a reduction of ECC~     incidence when compared to fluoride varnish application, written oral health education~     materials and oral health assessment and referral.~   "
141250|NCT01205958|"~     The purpose of this study is to assess the effect of East-West collaborative medicine on~     chronic cervical pain.~   "
141251|NCT01205945|"~     Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal~     diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third~     eventually rupture if left untreated.~      Several randomized trials showed that ultrasonographic screening for AAA could reduce the~     frequency of acute operations and AAA-related mortality.~      However, all of randomized trials were performed in Western countries. There was no~     randomized trials for AAA screening in Asian countries.~      This randomized, controlled trial is to analyze the benefits of screening old population for~     AAA in Korea.~   "
141252|NCT01205932|"~     The objective of this dose-confirmatory bridging study is to investigate the safety and~     efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous~     thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR)~     and to confirm the extrapolability of global data to Japanese patients by comparing with~     data from overseas phase II study (ODIXa-OD.HIP - Study 11527).~   "
141253|NCT01205919|"~     The purpose of this study is to determine the efficacy of a cognitive behavioral guided~     self-help training provided via the internet on tinnitus distress in a German sample.~   "
141254|NCT01205906|"~     The aim of this study is to compare the efficacy of an internet-based guided self-help~     training for chronic tinnitus with a well-established outpatient group therapy and a~     discussion forum group.~   "
141255|NCT01205893|"~     The purpose of this study is to determine if the Reducer is safe and effective in treating~     the symptoms of refractory angina in patients that suffer from refractory angina who~     demonstrate reversible ischemia.~   "
141256|NCT01205880|"~     This investigator-blinded study is designed to assess whether the order of application~     affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and~     Vecitcal® (calcitriol) Ointment in plaque psoriasis.~   "
141257|NCT01205867|"~     The purpose of this study is to investigate the safety and tolerability of AZD8848 in~     Butyrylcholinesterase deficient subjects in comparison with sex and age matched control~     subjects.~   "
141258|NCT01205854|"~     The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an~     absence of signs and symptoms of the disease. However, the optimal way of reaching this goal~     is not known.~      Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a~     number of advantages over other advanced imaging techniques such as magnetic resonance~     imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a~     short period of time. However, the additional benefit of using this modality in terms of~     patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US~     leads to better care for RA patients.~      This study will assess if the use of a treatment strategy incorporating information from~     ultrasonography assessment will allow for better outcomes of patients with RA, than a~     strategy based on clinical and laboratory assessments alone.~   "
141259|NCT01205841|"~     Comparison of the reliability of different examination techniques to detect fractures in~     patients with ankle trauma.~   "
141334|NCT01204931|"~     Gastroesophageal reflux disease (GERD) is currently defined as a condition which develops~     when the reflux of stomach contents causes troublesome symptoms and/or complications.~     Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In~     recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has~     increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or~     ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in~     this group pH monitoring has emerged as an important physiologic test to determine the~     degree of esophageal acid exposure and to assess the association between patients'~     persistent symptoms and acid reflux events. The aims of this study are to assess the~     sensitivity and specificity of symptom associated indices and determine the best parameter~     for predicting GERD from a list of conventional pH measurement findings.~   "
141260|NCT01205828|"~     This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in~     abbreviation).~      The purpose of this study is to test the efficacy (effectiveness) of a new combination of~     drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by~     damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer~     cells. ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By~     inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by~     the temozolomide and will hopefully increase the killing of cancer cells, and decrease the~     tumors in the body.~      ABT-888 is an investigational or experimental anti-cancer agent that has not yet been~     approved by the Food and Drug Administration (FDA) for use in liver cancer.~      This study will help find out what effects (good and bad) the combination of drugs,~     temozolomide and ABT-888, has on liver cancer.~      This research is being done because it is not known if ABT-888 will increase the~     effectiveness of temozolomide in liver cancer.~   "
141261|NCT01205815|"~     The purpose of this research is to identify biological characteristics occurring in the~     initiation and progression of melanoma.~   "
141262|NCT01205802|"~     Middle hepatic vein (MHV) reconstruction with an interposition vessel graft has been settled~     as a standard procedure for living donor liver transplantation (LDLT) using a right lobe~     graft. Increasing demand of vessel graft in the situation of limited resources of allograft~     led the investigators to search for new vessel substitutes. Since the use of thin-walled~     expanded polytetrafluoroethylene (PTFE) graft showed poor long-term patency, a prospective~     study is going to be performed to enhance the clinical usability of expanded PTFE graft. A~     clinical study intends to know how to maintain its luminal flow effectively by using ringed~     PTFE graft. During 12 months of study period, ringed PTFE graft will be used for~     reconstruction of MHV reconstruction. The investigators expect that ringed PTFE graft seems~     to be a more useful alternative than usual PTFE graft when adequate autologous or allogenic~     vessel graft is not available.~   "
141263|NCT01205789|"~     The purpose of the Universal Registry is to assess the proportion and reasons for which~     subjects with angiographically significant ULMCA disease requiring revascularization during~     the time course of this study are not randomized; to compare the baseline characteristics of~     subjects; and to assess the variability in randomization eligibility and treatment patterns.~   "
141264|NCT01205776|"~     To establish the safety and efficacy of the commercially approved XIENCE Family Stent System~     (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the~     United States [OUS] only]) in subjects with unprotected left main coronary artery disease by~     comparing to coronary artery bypass graft surgery.~   "
141265|NCT01205763|"~     In this study, the investigators intend to demonstrate that the hook plate may have adverse~     effects on subacromial structures even with a short period of hardware retention. The~     investigators also sought to determine if musculoskeletal sonography could be used as a tool~     to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in~     patients receiving hook plate fixation. The clinical results of patients receiving hook~     plate fixation, specifically bony union, pain relief, shoulder function and range of motion~     (ROM), were also evaluated.~   "
141266|NCT01205750|"~     Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart~     disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins,~     and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that~     increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central~     pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia.~      The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin~     sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and~     during acute hyperinsulinemia using VLDL-TG and glucose tracers.~   "
141267|NCT01205737|"~     This is a prospective international, multi-center, randomized, double-blind controlled study~     designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of~     MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse~     large B cell lymphoma.~   "
141268|NCT01205724|"~     This trial is conducted globally. The aim of this clinical trial is to investigate the~     safety and pharmacokinetics (the determination of the concentration of the administered~     medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with~     severe haemophilia A.~   "
141269|NCT01205711|"~     RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and~     leucovorin calcium, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Zibotentan may be effective in treating~     metastatic colorectal cancer that has not responded to oxaliplatin. It is not yet known~     whether combination chemotherapy is more effective when given with or without zibotentan in~     treating metastatic colorectal cancer.~      PURPOSE: This randomized phase II trial is studying giving irinotecan hydrochloride together~     with fluorouracil and leucovorin calcium to see how well it works when given with or without~     zibotentan in treating patients with metastatic colorectal cancer.~   "
141270|NCT01205698|"~     This clinical trial will determine the effect of varying types of carbohydrates contained in~     milk-based beverages on the glycemic response and GI values.~   "
141271|NCT01205685|"~     Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in~     human beings show that this drug can make a difference in the way anti-estrogens work in~     hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that~     helps them live and grow. Studies done in the laboratory show that OSI-906 can make a~     difference in the way anti-estrogens work in hormone-sensitive breast cancers.~   "
141272|NCT01205672|"~     The goal of this research study is to learn if metformin can affect endometrial cancer cells~     in women who do not have diabetes.~      Objectives:~      Primary Objectives:~      1. To determine the molecular effects of metformin and associated physiologic changes in~     insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in~     the endometrium of women with endometrial cancer~      Secondary Objectives:~        1. To describe the effects of metformin on the histology and proliferation of the~          endometrium in women with endometrial cancer.~        2. To assess the effect of body mass index on the response to treatment with metformin~        3. To assess the effect of insulin resistance on the response to treatment with metformin~        4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with~          endometrial cancer.~   "
141273|NCT01204684|"~     The main purpose of this study is to evaluate the most effective immunotherapy vaccine~     components in patients with malignant glioma. Teh investigators previous phase I study (IRB~     #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant~     brain tumors, and with an indication of extended survival in several patients. However, the~     previous trial design did not allow us to test which formulation of the vaccine was the most~     effective. This phase II study will attempt to dissect out which components are most~     effective together. Dendritic cells (DC) (cells which present or show cell identifiers~     to the immune system) isolated from the subject's own blood will be treated with tumor-cell~     lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing~     (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the~     immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed~     DCs will then be injected back into the patient intradermally as a vaccine. The~     investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like~     cell) in some treatment cohorts. It is thought that the host immune system might be taught~     to recognize the malignant brain tumor cells as foreign to the body by effectively~     presenting unique tumor antigens to the host immune cells (T-cells) in vivo.~   "
141274|NCT01204671|"~     This study is designed to assess the safety and immunogenicity of a GSK Biologicals'~     investigational vaccine GSK2321138A in adults 18 years old and older. This study is also~     designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be~     double blind for all groups except for the GSK2604409A Group which will be open.~   "
141275|NCT01204658|"~     This study will assess the safety, reactogenicity and immunogenicity of two formulations of~     GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course~     during the first 6 months of life followed by a booster dose at 12-15 months of age and~     co-administered with DTPa-HBV-IPV/Hib vaccine.~   "
141276|NCT01204645|"~     Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming~     recognized as one of the most serious disorders causing increased risk for cardiovascular~     disease and death. In patients with ischemic heart disease 26% have increased creatinine,~     which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function~     diminishes, and just slowing the rate of decline in renal function would have a tremendous~     impact on health and morbidity. This association is commonly termed the Cardiorenal~     Syndrome, though it is caused by a much more complex interplay between major pathogenetic~     pathways such as glucose metabolism and diabetes, systemic and tissue inflammation, tissue~     metabolism, coagulation, mineral metabolism, sympathetic activation,~     renin-angiotensin-aldosterone system activation, endothelial dysfunction, lipid metabolism,~     fetal programming etc.~      Karolinska Institutet recently merged basic and clinical researchers in all these fields,~     creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome~     and provide improved care for the individual patient.~      The investigators road to success:~        -  Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients~          with ACS in Stockholm county - Stockholmheartbank.~        -  This Theme Center include all teaching hospitals associated with Karolinska Institutet;~          Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset~          University Hospital. Together theses hospitals serve as emergency hospitals for 1.9~          million people. The investigators are aiming at creating a biobank from all patients~          admitted for an acute coronary event (about 2.300/yr), which is a unique asset for~          molecular and genetic research as well as observational and intervention studies.~        -  The investigators have access to the National registry with 100% coverage, that~          contains data on all patients admitted to Stockholms coronary care units since 1995.~        -  To ensure translation in to clinical practice, most of the researchers are also MD:s,~          and several are clinically active.~        -  The clinical network facilitates the development of novel therapies and translational~          research.~        -  Steering groups for Education and a Clinical Practice implementation program.~   "
141277|NCT01204632|"~     The purpose of this study is to develop and field-test new tools for diagnosis and hazard~     assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and~     to advance the evidence base with much needed information on CMR and cardiovascular disease~     (CVD) burden in people with SCI. These data can be used to develop screening guidelines for~     early identification and prevention of CMR in SCI, as well as targeted approaches to primary~     disease management.~   "
141278|NCT01204619|"~     Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis~     for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients~     on PD has continued to decrease each year. There have been a growing concern and research on~     patient and technique survival of peritoneal dialysis versus hemodialysis to find~     influential factors for better clinical outcomes. Meanwhile, technique failure rates were~     significantly higher in small centers treating less than twenty five PD patients. And there~     was a result for better technique survival after the second year, among the patients trained~     at the BREC(Baxter Renal Education Center). Better technique survival in large centers can~     be assumed with not only their more experience with patient management but also their~     educational infrastructure compared to small-sized centers.~      Throughout our experiences in the last 30 years, we have recognized that a major element of~     PD program is patient training, however few data are available in terms of the relationship~     between PD training and treatment outcome and mostly are retrospective and non-randomized.~     Moreover, the technique survival and patient survival were analyzed with no significant~     difference.~      From the insight, we decided to study prospectively to evaluate the efficacy of~     well-structured education program in terms of various patient outcomes in incident patients~     on PD.~   "
141279|NCT01205659|"~     Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized~     trials of supplemented infant formula during infancy conducted by The Retina Foundation of~     the Southwest .~   "
141280|NCT01205646|"~     The primary goal for this trial is to assess the change in PET scans with the administration~     of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has~     been established that zoledronate therapy may play a role in delaying and reducing the~     incidence of skeletal events. Researchers propose to evaluate the change in the uptake value~     of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans~     can successfully demonstrate and detect bony metastatic sites in prostate cancer.~      In addition, investigators would like to evaluate the change in the level of the~     prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.~   "
141281|NCT01205633|"~     Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and~     if appropriate treated with catheter venoplasty by an interventional radiologist in their~     local community who has been credentialled either by the local hospital's IRB or a national~     IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a~     long-established and accepted medical procedure, patients' insurance should but may not~     cover the testing or treatment.~   "
141282|NCT01205620|"~     Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:~        -  treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)~        -  no ITPR .Anesthesia will be standardized for both groups. The groups will be compared~          based on the differences in vasopressor use, the number and amount (in milliliters) of~          intravenous fluid boluses required and hemodynamic changes noted, including systemic~          blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most~          reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous~          oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume~          (SV).~      Specifically, we will compare the groups based on the mean number of intravenous fluid~     boluses, mean amount of norepinephrine and epinephrine infusion required, the number of~     recorded systolic blood pressures < 90 mmHg, and number of CI < 2.0 L/min/m2. We will also~     compare the number of times the surgeon must reposition the heart for treatment of~     hypotension, and ascertain whether the ITPR will help patients tolerate the cardiac~     displacement better, thus decreasing the time required to complete the bypass graft~     anastamosis. ECG will be monitored intraoperatively for signs of ischemia including ST~     changes, greater than 1mm depression or elevation. Postoperatively, we will record the need~     for and amount of diuretic required.~      We hypothesize that in this pilot study, patients undergoing OPCAB who are treated with~     CirQlator TM Intrathoracic Pressure Regulator (ITPR) will achieve higher blood pressures and~     cardiac output and require less intravenous fluids and vasopressor administration than~     patients managed without the ITPR.~   "
141283|NCT01205607|"~     Patients who have a functioning intracranial pressure-monitoring device (either a~     subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated,~     intubated, and mechanically ventilated (i.e. in the NNICU), or are scheduled to undergo an~     operation or interventional neuroradiological procedure at the University of Virginia.~     Patients with a contraindication to TTE will be excluded.~      For patients in the NNICU, basic hemodynamic variables (systemic blood pressure, central~     venous pressure, etc.) will be collected. In addition, left ventricular performance~     (including estimates of LVEDV, LVESV, EF, FAC, and SV) will be assessed using TTE. Once~     these baseline data are recorded, the ITPR will be inserted in the ventilator circuit and~     activated to provide either -5 mm Hg or -9 mm Hg endotracheal rube pressure (ETP) (based on~     a randomization scheme). After the ITPR has been active for at least five minutes, the same~     intracranial, hemodynamic, and TTE data obtained above will be gathered. The ITPR will then~     be turned off for five minutes, and intracranial, hemodynamic, and TTE data will again be~     recorded. The ITPR will be activated a second time (-9 mm Hg or -5 mm Hg ETP, i.e. whichever~     value was not used previously), and after five minutes of use data will be recorded again.~     The ITPR will then be disconnected, data will be collected after waiting two minutes, and no~     further interventions will be made.~      ABG's will be obtained before and during the use of the device at each setting.~      This is a proof of concept/feasibility study designed to test the primary hypothesis that~     use of the ITPR will result in decreased intracranial pressure and increased cerebral~     perfusion pressure. The effect of the ITPR on secondary indicators of cardiac performance~     will also be examined. These include but are not limited estimates of ventricular end~     diastolic volume and pressure (LVEDV/P), ejection fraction (EF), left ventricular end~     systolic volume and pressure (LVESV/P), fractional area change (FAC), all of which will be~     assessed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).~   "
141284|NCT01205594|"~     Briefly, after the induction of anesthesia and the placement of TEE, hemodynamic variables~     (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac~     output, calculated SVR, etc.) will be collected. In addition, left ventricular performance~     (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE. Once these~     baseline data are recorded, the ITPR will be inserted in the anesthesia circuit and~     activated to provide -9 mmHg ETP. After the ITPR has been active for at least two minutes,~     the same hemodynamic and TEE data obtained above will be gathered. After the data is~     recorded, the ITPR will be disconnected and no further interventions will be made. In~     addition to the hemodynamic and echocardiographic data described above, an arterial blood~     gas will be obtained from the pre-existing radial artery catheter during the on- and off-~     states.~      Finally, the TEE examination will be recorded on videotape or DVD. A second~     echocardiographer, blinded to patient and ITPR status will review each echocardiogram and~     assess left ventricular performance. In addition to the data derived at the time of testing,~     the second echocardiographer will assess, if possible, changes in EF using Simpson's method~     of disks is used to calculate the LV volume.~      This is a proof of concept/feasibility study designed to test the primary hypothesis that~     use of the ITPR will result in increased systemic blood pressure and cardiac output in~     patients undergoing CABG surgery. The effect of the ITPR on other secondary indicators of~     cardiac performance will also be examined. These include but are not limited to left~     ventricular end diastolic volume (LVEDV), ejection fraction (EF), left ventricular end~     systolic volume (LVESV), and fractional area change (FAC) as assessed by echocardiography,~     pulmonary artery pressure, and calculated systemic vascular resistance (SVR).~   "
141285|NCT01205581|"~     This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated~     influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or~     HIV will be vaccinated twice with one of the two vaccines and evaluated for development of~     immune responses.~   "
141286|NCT01205568|"~     The primary objective of this study is to evaluate the safety and efficacy of transcatheter~     Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure~     dilation.~   "
141287|NCT01205555|"~     Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one~     of the most commonly used treatments for infertility. Accurate timing of insemination, in~     order to coincide with ovulation, has an important impact on the success rate. Optimal~     timing of insemination is achieved either by monitoring follicular growth through serial~     ultrasound measurements followed by the administration of human chorionic gonadotropin (hCG)~     or by the detection of urinary luteinizing hormone (LH). However in cycles where follicular~     growth is monitored there is a possibility of premature LH rise before the administration of~     hCG, which may affect the outcome of the treatment. The goal of the study is to determine if~     adding the testing of urine LH in conjunction with ultrasound monitoring leads to an~     increase in pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.~   "
141288|NCT01205542|"~     Basic strength training for the neck/shoulder muscles can decrease intensity of~     neck/shoulder pain, but it is uncertain whether training should focus directly on the upper~     trapezius - which is most often tender - or on the lower compartments and serratus anterior.~      We hypothesize that strengthening exercise for the lower and middle trapezius as well as the~     serratus anterior will decrease intensity of neck/shoulder pain among office workers~   "
141289|NCT01205529|"~     The purpose of this study is to look for a similarity in people's genes that may help~     understand which people could benefit from certain drugs for the treatment of atrial~     fibrillation.~   "
141335|NCT01204918|"~     This study aims to examine the antidepressant efficacy of riluzole, employing a randomized,~     double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive~     disorder (TRD).~   "
141350|NCT01204723|"~     The primary objective of this application is to test the neurobehavioral mechanisms and~     effects of aprepitant as a new cessation agent for cannabis, tobacco or both.~   "
141351|NCT01204710|"~     This is a study evaluating the safety and efficacy of the monoclonal antibody IMC-3G3 plus~     mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic~     castration-refractory prostate cancer following disease progression or intolerance on~     docetaxel-based chemotherapy.~   "
141290|NCT01205516|"~     INTRODUCTION: There is an important need for inexpensive drugs that treat neuropathic pain.~     Early research suggests that methadone may be a good, inexpensive drug to treat neuropathic~     pain. Methadone is available in a low cost powder that is easily prepared for different~     routes of administration. This study will look at the effect and safety of methadone~     compared to the regular treatment of morphine for the treatment of chronic neuropathic pain.~      OBJECTIVES: First the investigators want to determine if methadone is effective and safe for~     the treatment of neuropathic pain. Since a placebo control group would be unethical, the~     proposed comparator will consist of the gold standard conventional treatment, controlled~     release morphine. The investigators will compare methadone to controlled-release morphine~     with regard to how it affects the level of pain and extent of side effects. Next the~     investigators want to examine safety as well as to determine whether methadone leads to~     improvements in physical and emotional functioning, and participants' satisfaction with the~     treatment.~      METHODS: A double blind, randomized trial comparing methadone and controlled release~     morphine is proposed. After 1-week, participants will be randomly assigned to either~     methadone or controlled release morphine and will gradually build to a dose at which they~     receive adequate pain relief without unacceptable levels of side effects. This 5-week phase~     will be followed by a 6-week dose phase and then a 4-week tapering off phase.~      Study drug: The study drug is methadone supplied in 2.5 mg tablets. The comparator will~     consist of controlled release morphine in 10 mg tablets. The dose of each will range from~     1-12 tablets taken every 12 hours (dose ranges methadone 5-60 mg/day, controlled release~     morphine 20-240 mg/day).~      Setting: This is a 3-site study involving pain clinics in Halifax, Nova Scotia; London,~     Ontario; and Calgary, Alberta.~   "
141291|NCT01205503|"~     The purpose of this study is to determine whether the drug mesna is able to block a series~     of chemical changes that occur in the blood of patients who receive the chemotherapy~     medicine doxorubicin. The researchers believe these blood chemical changes may the cause of~     cloudy thinking or chemobrain that are reported by some patients receiving chemotherapy.~   "
141292|NCT01205490|"~     The investigators are performing a study to determine whether changes in blood flow occur in~     the neck and back of the brain following a series of head positions and a manipulation of~     the upper neck. Each participant will be asked to undergo a series of MRI's to evaluate~     whether there are any changes in blood flow resulting from any of the head positions or~     manipulation. The study will be conducted over a period of 1 day and each participant can~     anticipate the testing to take approximately 120 minutes.~   "
141293|NCT01205477|"~     To investigate the safety and efficacy of methylprednisolone infiltration in anserine~     bursitis treatment~   "
141294|NCT01205464|"~     The aim of this randomised, double-blind crossover study was to determine whether~     Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through~     alterations in the immune response and whether such an effect could influence the clinical~     outcome.~   "
141295|NCT01205451|"~     This trial is a multicenter, open-label study to evaluate the safety and efficacy of~     GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases,~     thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be~     enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 200U~     or 240U (if thumb spasticity is present). The subjects will be observed until 12 weeks post~     injection. Outcome measures include changes from baseline at every post injection visit as~     measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global~     Assessment Scale. Safety parameters will be measured including adverse events, vital signs~     (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and~     urinanalysis).~   "
141296|NCT01205438|"~     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two~     different doses of LY2127399 administered in addition to standard of care therapy in~     patients with active SLE.~   "
141297|NCT01205425|"~     The purpose of the study is to determine whether results of the computed tomography coronary~     angiography may be helpful in planning and performing percutaneous angioplasty in patients~     with stable angina pectoris.~   "
141298|NCT01205412|"~     The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV~     type distribution among women ≥ 20 years of age attending routine cervical screening and~     among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.~   "
141299|NCT01205399|"~     This study will enroll subjects who underwent a ventral hernia repair using the AlloMax~     Surgical Graft at least 9 months in the past.~      All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least~     9 months in the past will be contacted and asked to take part in this clinical study. The~     consented subjects' medical records will be reviewed for evidence of any risk factors of~     hernia recurrence, procedure time, complications and any documented recurrences. The~     subjects will be asked to undergo a physical exam to rule out any recurrences that were not~     documented in the medical records.~   "
141300|NCT01205386|"~     The purpose of this study is to determine if the CROSSER CTO Recanalization System can~     facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the~     Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100%~     narrowing of the artery, with no angiographically detectable antegrade blood flow, and the~     assessment that the lesion has been in existence for a minimum of 30 days. This study will~     enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System~     was cleared for commercialization by the US Food & Drug Administration. This study also~     involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This~     device has been cleared for commercialization by the US Food and Drug Administration and~     will be studied for its cleared intended use. The IVUS catheter is used to generate~     real-time images of the artery, which will allow for evaluation of the artery after the~     occlusion is crossed. This is a post-market registry.~   "
141301|NCT01205373|"~     The main objectives of the present study are to investigate the basic pharmacokinetics of BI~     671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance,~     excretion pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA~     to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability~     following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.~   "
141302|NCT01205360|"~     The purpose of this study is to determine how manipulation of the programmed intermittent~     time interval and volume influences total drug use, quality of analgesia, and patient~     satisfaction during maintenance of labor analgesia.~   "
141303|NCT01205347|"~     Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and~     long term. Recent studies, however, revealed that chronic statin treatment may decrease both~     insulin sensitivity and secretion immediately after statin therapy initiation. This study~     aim was to investigate the dose-dependent effect of statins on insulin sensitivity in~     patients in the acute phase of MI.~   "
141304|NCT01205334|"~     Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come~     back after standard therapy, patients are being asked to volunteer to take part in a~     research study using special immune cells. They may have already thought about being in this~     study.~      Some patients with GBM show evidence of infection with a virus called Cytomegalovirus before~     the time of their diagnosis. CMV is found in the cancer cells of some patients with GBM,~     suggesting that it may play a role in causing the disease. The cancer cells infected by CMV~     are able to hide from the body's immune system and escape destruction. We want to see if~     special white blood cells, called T cells, that have been trained to recognize and kill~     special parts of CMV infected cells can survive in the blood and affect the tumor.~      We have used this sort of therapy to treat different types of cancer that are positive for~     other viruses and have had variable results. Some patients have had responses others did~     not. It is not possible for us to predict if this treatment will work for GBM.~      The purpose of this study is to find the largest safe dose of CMV-T cells, to learn what the~     side effects are, and to see whether this therapy might help patients with GBM.~   "
141305|NCT01205321|"~     Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)~     images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.~   "
141306|NCT01205308|"~     In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity~     and mortality. Although serum cholesterol concentrations are not always elevated in T1D,~     cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is~     enhanced. The aim of this study is to investigate the effects of plant stanol esters on~     serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol~     concentrations as well as cholesterol metabolism in T1 diabetics on statin use. The study~     will give new information about how addition of plant stanol esters on statin use improve~     hypolipidemic effects in type 1 diabetes.~   "
141307|NCT01205295|"~     Background: Previous studies have shown that anxiety and dissatisfaction with patient~     progress are predictors for increased postoperative pain and reduced impact and efficacy of~     pain treatment. However, it remains to be shown whether patient anxiety and concern are~     predictors for the perceived quality of patient progress and the perceived efficacy of~     treatment.~      The aim of this study is to investigate whether there is a correlation between preoperative~     anxiety and concern, and the perceived quality and efficacy of postoperative treatment. The~     hypothesis is that anxious and concerned patients are less satisfied with treatment and have~     a poorer response of their treatment.~      Methods/design: This PhD-project consists of four coherent studies. 1) A methodological~     study evaluating the CMD-SQ (Common Mental Disorder - Screening Questionnaire) questionnaire~     by a test-retest study. 2) The main study, a prospective follow-up study, has the aim of~     investigating the correlation between patient anxiety and concern, their perceived quality~     of patient progress and the perceived efficacy of treatment. This correlation will be~     detected by means of five questionnaires: CMD-SQ, EQ-5D, SF-12, HVOK, OHS or OSS. 3) A study~     consisting of an explicit internal medical audit with the aim to investigate whether the~     medical assessment of patient efficacy of treatment is consistent with their own~     self-reported efficacy of treatment. 4) An intervention study designed as a randomized~     clinical trial. The aim is to investigate whether a targeted effort towards patients with a~     high score of CMD-SQ, i.e. patients with anxiety and concern, can increase their~     self-reported efficacies of treatment and their perceived quality of progress. A total of~     800 hip- and shoulder-patients will be included.~      Discussion: If a correlation between patient anxiety and concern, their perceived quality of~     progress and the perceived efficacy of treatment is found, it will be relevant to screen all~     hip- and shoulder-patients for anxiety and concern preoperatively and deal with this before~     their operation. This study will provide a proposition of how these patients can be taken~     care of through cognitive behavioural therapy as a targeted effort towards their anxiety and~     concern.~      Aim and hypothesis: The aim of this study is to investigate whether there is a correlation~     between patient anxiety and concern, and their perceived quality and efficacy of treatment.~     The overall hypothesis is that patients who are anxious and concerned are less satisfied~     with their treatment and have a poorer overall efficacy of their treatment.~   "
141308|NCT01205282|"~     The investigators propose a pilot, single blind, placebo run-in, dose finding study of~     pioglitazone in children with autism with the ultimate goal of identifying appropriate~     dosing and outcome measures for a larger follow-up randomized placebo controlled clinical~     trial. The specific aims of this study are: 1) To examine the safety of pioglitazone in~     children with autism spectrum disorders (ASD) ages 5-12 years; 2) To identify appropriate~     outcome measures to be used in a follow-up multisite randomized control trial of~     pioglitazone in children with ASD; 3) To determine the maximum tolerated dose to be used in~     the follow-up multisite randomized controlled trial; 4) To examine the effect of~     pioglitazone on markers of inflammation (cytokine levels) and oxidative stress (superoxide~     dismutase, malonyl aldehydes); 5) To explore the relationship between different doses and~     response to treatment.~   "
141309|NCT01205269|"~     The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo~     in COPD patients.~   "
141310|NCT01205256|"~     This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A~     total of approximately 15 patients will be required. The purpose is to determine the levels~     of R, S methadone at various time intervals after drug administration. Patients will receive~     methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and~     propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients~     will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be~     utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to~     VAS scores, patient and parental satisfaction with analgesia, and a functional pain~     assessment.~   "
141311|NCT01205243|"~     An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor~     the safety and efficacy of ZIAGEN® administered in Korean patients according to the~     prescribing information.~   "
141312|NCT01205230|"~     The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or~     esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also~     test for safety of pazopanib when administered with ketoconazole or esomeprazole.~   "
141313|NCT01205217|"~     This study will test the safety of a drug called lapatinib and how well it works. Lapatinib~     (also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called~     Herceptin).~      Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to~     stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers~     the rate of cancer recurrence and improves survival in women with HER2 positive breast~     cancer.~      Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing~     and may prevent cancer from returning. Lapatinib has been approved in some countries to~     treat patients with certain types of breast cancer. However lapatinib has not been approved~     to treat early breast cancer. This study is one of many being carried out involving~     lapatinib in early breast cancer and these studies are showing that it is a promising~     treatment.~      This study will compare lapatinib and trastuzumab. One group of people will take lapatinib~     and another group will take trastuzumab. The effects of the drugs, both good and bad, will~     be compared. This study will compare two different durations of HER2 treatment to see if~     earlier introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2~     treatment from the very beginning for 24 weeks prior to surgery and the trastuzumab group~     will only receive HER2 therapy for 12 weeks prior to surgery.~   "
141315|NCT01205191|"~     Definitions~      CBT-ubiquitous - Cognitive behavioural therapy (CBT) provided with all-time (ubiquitous)~     support by cell phone applications CBT-TAU - Cognitive behavioural Therapy provided 'As~     Usual' CBT-placebo - Cognitive behavioural therapy provided with access to a digital audio~     player with self-administered materials for stress management and relaxation.~      Study objectives~        1. to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous)~          against anxiety disorders with CBT-treatment as usual (CBT-TAU);~        2. to assess the safety and tolerability of the CBT-ubiquitous as compared with CBT-TAU~          and CBT provided with access to a placebo technical device (CBT-placebo)..~      Study implementation~      The investigators hypothesize that all active treatments are superior to placebo given~     evidence that face-to-face CBT is effective in the treatment of both anxiety and depression.~     The investigators also predict that patients receiving CBT-ubiquitous will show greater~     improvement than those given CBT-TAU, and assume that CBT-ubiquitous leads to improved~     adherence with treatment compared to CBT-TAU and CBT-placebo.~      The investigators will use an intention to treat (ITT) approach to fulfill the study aims,~     by which the investigators mean that clients are analysed as randomized rather than by~     treatment actually received. The study will be implemented in the central district of~     Östergötland County Council (pop 145.000). The research group has in two previous projects~     (VINNOVA 2005-2007, VINNOVA 2008-2009) established cooperation with the 'Unga Vuxna' (Young~     Adults) service provided in this district. The service supplies CBT to the subpopulation~     experiencing early stages of mental disorders in the age group 16-25 years (n=20,000) in~     order to prevent development of significant psychiatric disease and disability. The service~     employs six therapists with at least one year specific CBT training and is co-located with~     Primary Healthcare Centres (PHCs) in downtown Linköping, Åtvidaberg and Kisa. Clients~     staying outside the urban areas can make appointments with therapists at their closest PHC~     on a weekly basis.~   "
141316|NCT01205178|"~     SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed~     by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and~     Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of~     acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3~     days.~      The current gold standard for radical cure of P. vivax malaria in many areas of the world is~     chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine~     (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class~     of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase~     (G6PD) deficiency. The current study will identify a dose of TQ within the target~     efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14~     days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).~   "
141317|NCT01205165|"~     Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of~     adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated~     liver disease. The secondary study objectives are to assess the antiviral effect, clinical~     benefit and safety of 52 weeks of adefovir dipivoxil treatment.~      Endpoint(s) The primary efficacy endpoint is Mean log10 reduction in serum HBV DNA level~     from baseline to Week 12.~      The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT~     normalization at Week 52, (b) other assessments of antiviral effects (the proportion of~     patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg~     seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving~     serum ALT normalization at Week 12.~      Study Design This is an open label, multi centre phase IV study for Korean patients with~     chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12~     weeks treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical~     benefit and safety of 52 weeks treatment as secondary objectives.~      Patients will be screened for eligibility criteria and the baseline visit for the treatment~     initiation should occur no more than 4 weeks after screening. Total treatment period will be~     52 weeks and patients will return to the clinic for assessments as scheduled during~     treatment period. After the 52 week study period, it is likely that the patient will benefit~     from continued treatment with commercial adefovir. If in the investigator's clinical~     judgement this is the case, the investigator should ensure that a routine prescription is~     available in a timely manner, and that no unnecessary interruption in treatment occurs.~      Study Population A minimum of 100 male or female Korean patients more than 18 years of age~     with HBeAg positive chronic hepatitis B and compensated liver disease who meet the~     eligibility criteria will be enrolled.~      Study Assessments and Procedures~      Potential patients will be screened prior to study entry and eligible patients who have~     given their consent will have further baseline assessments. Following the screening, the~     first doses of study medications will be given at baseline and patients will return to the~     clinic for assessment as scheduled during treatment period. Patients who discontinue~     treatment prematurely will be followed up every 4 weeks for 12 weeks following the~     withdrawal visit. The following key assessment and or measurement will be made at one or~     more visits during the study. (See section 14.1 Appendix 1. Time and event schedule):~        -  Pregnancy test (females of child-bearing potential only)~        -  Haematology and serum chemistry profile including prothrombin time(PT) and AFP~        -  HBV DNA (Roche COBAS AMPLICOR HBV MONITOR Test, LLOD 300 copies per ml)~        -  Hepatitis B markers: HBeAg(Anti HBe will be tested if HBeAg is negative), HBsAg(Anti~          HBs will be tested if HBsAg is negative) Investigational Product(s) Adefovir dipivoxil~          10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white,~          round tablets, packaged in the bottle containing 30 tablets~   "
141318|NCT01205152|"~     This clinical trial studies the long term safety and efficacy of asfotase alfa in infants~     and young children with infantile onset HPP who completed the ENB-002-08 study.~      Partial funding for this study was provided by the Office of Orphan Product Development~     (OOPD).~   "
141319|NCT01205139|"~     The purpose of this study is to investigate the effect of steady-state concentrations of~     TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa. Steady~     state is a term which means that the drug has been given long enough so that the plasma~     concentrations will remain the same with each subsequent dose. TMC435 is being investigated~     for the treatment of chronic hepatitis C virus (HCV) infection. TMC278 and Tenofovir are two~     antiretroviral drugs for treatment of human deficiency virus (HIV) infection.~     Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in~     the body and eliminated from the body.~   "
141320|NCT01205126|"~     The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic~     System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in~     participants with cancer-related pain.~   "
141321|NCT01205100|"~     Background: Abdominal bloating is a frequent and bothersome complaint in patients with~     functional gut disorders without satisfactory treatment to date. Recent data from our~     laboratory indicate that abdominal distention in these patients is produced by~     abdomino-phrenic dyssynergia: diaphragmatic contraction associated with abdominal wall~     relaxation (particularly the internal oblique). In analogy to other clinical situations~     (e.g. functional outlet obstruction, rumination or aerophagia) behavioral treatment by means~     of biofeedback might be equally effective in these patients. The investigators hypothesized~     that abdomino-phrenic coordination and abdominal distention can be controlled by biofeedback~     techniques.~      Aim: to prove the efficacy of behavioural treatment using biofeedback techniques for~     abdominal distension.~      Randomization: Patients will be randomized into biofeedback and placebo groups.~      Intervention. Biofeedback: patients will be taught to control abdominothoracic muscular~     activity by bio-feedback using online electromyography information. Placebo: patients will~     be given a pill containing placebo medication. Interventions will be delivered in 3 sessions~     (20 min each) over 10-day period~      . Measurements: Sensation of abdominal distension will be assessed by means of graphic~     rating scales graded from 0 (no perception) to 6 (very intense sensation). The activity of~     the abdomino-thoracic muscles will be recorded. Abdominal distension will be measured by a~     metric tape fixed to a non-stretch belt placed over the umbilicus.~      Outcomes: Primary outcome: Change in sensation of abdominal sensation. Secondary outcomes:~     a) changes in thoraco-abdominal activity of the muscular walls; activity of~     thoraco-abdominal muscles (intercostals, diaphragm, external oblique, internal oblique,~     upper rectus, lower rectus) will be measured by electromyography; b) changes in girth;~     abdominal girth will be measured using a nonstretch belt (48mm wide) that is placed over the~     umbilicus. The overlapping ends of the belt will be adjusted carefully with two elastic~     bands to adapt constantly to the abdominal wall.~   "
141322|NCT01205087|"~     This clinical study is designed to evaluate the safety and immune modulatory effects of oral~     administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the~     metabolic syndrome.~   "
141374|NCT01204320|"~     This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty~     or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the~     evaluation of restenosis by Quantitative Coronary Analysis.~   "
141323|NCT01205074|"~     Several factors will be tested to see if they have an influence on the methacetin breath~     test results. Each one of the factors has been raised as a possible source of distortion of~     the MBT result.~      I. Variability between same tests on same subject MBT. Repeatability will be tested in both~     healthy individuals and patients with chronic liver disease.~      II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and~     can potentially have an effect on the MBT since the breath test is based on CO2 production~     and these subjects may have abnormal CO2 production.~      III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic~     microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore,~     internal preliminary data has shown signs that there is an influence of smoking on the MBT~     ranges.~      IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown~     that age is a significant factor in determining the probability of disease severity and~     preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the~     effect of age has to be elucidated in an orderly fashion.~      V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the~     MBT.~      VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to~     inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.~      VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic~     blood flow and thereby the outcome of the methacetin breath test.~   "
141324|NCT01205061|"~     The purpose of the study is to compare the effectiveness and safety of Emervel Deep~     Lidocaine versus Juvederm® Ultra Plus in the treatment of moderate to severe facial wrinkles~     and folds.~   "
141325|NCT01205048|"~     The purpose of this study is to compare the effectiveness and safety of Emervel Classic~     Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and~     folds.~   "
141326|NCT01205035|"~     Idiopathic Parafoveal Telangiectasia (IPT) [also known as Idiopathic Perifoveal~     Telangiectasia, Idiopathic Juxtafoveal Telangiectasia (IJT, JFT) and Macular Telangiectasia~     (MacTel)] is a disorder of unknown etiology. IPT is classified as Group 2A in the Gass~     classification of macular telangiectasias (Reference 1,5) - a bilateral, but not always~     symmetric disorder. It is characterized in its early stages by dilation and loss of~     parafoveal capillaries accompanied by angiographic leakage, right angle venules, central~     and parafoveal intraretinal cysts.~   "
141327|NCT01205022|"~     RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or~     carry tumor-killing substances to them without harming normal cells. Giving radioactive~     substances together with antibodies may be effective treatment for some advanced cancers.~     Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin~     calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing~     substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood~     flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination~     chemotherapy and bevacizumab may be an effective treatment for colorectal cancer.~      PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of~     yttrium Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given~     together with combination chemotherapy and bevacizumab in treating patients with metastatic~     colorectal cancer.~   "
141328|NCT01205009|"~     In an era of delayed fertility plans, there is increasing need for fertility treatment in~     older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to~     treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.~   "
141329|NCT01204996|"~     The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when~     administered to patients with solid tumors in combination with 4 standard of care~     chemotherapy regimens.~   "
141330|NCT01204983|"~     Human milk is associated with substantial benefits to infants' health and development,~     especially in premature infants. Some mothers are unable or unwilling to provide breast milk~     to their infant. The use of donor human milk as an alternative to cow milk in these infants~     has risen dramatically in the past year. However, there have been recent reports of~     hyperphosphatemia and hyponatremia associated with the consumption of donor human milk~     products. These electrolyte imbalances can lead to concerning symptoms, including headache,~     nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important~     to recognize and appropriately treat these electrolyte disturbances associated with donor~     human milk to avoid potential nutritional problems.~   "
141331|NCT01204970|"~     Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive~     pulmonary disease (COPD) and lung transplant recipients is described and will be correlated~     with clinical findings in order to described small airway remodelling in these patients.~   "
141332|NCT01204957|"~     Japanese postmenopausal women in Japan have about one ninth the rate of American~     postmenopausal women. Rates of breast cancer double even after just ten years among Japanese~     women who migrate to the US. Diet is thought to be an important factor, and the~     investigators were interested in whether dietary seaweed, with and without soy supplements,~     could influence known biomarkers of breast cancer risk in American women.~   "
141333|NCT01204944|"~     The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all~     patients after solid organ and stem cell transplantation since 5/2008 in Switzerland.~     Predefined variables are collected at defined time points. Individual samples (PBMC, plasma,~     DNA) will be stored for future projects. Data relevant to transplantation outcome with~     emphasis on immunological and infectious complications as well as psychosocial variables~     will be gathered.~   "
141336|NCT01204905|"~     This is a pilot, open-label study of raltegravir and maraviroc in combination for the~     treatment of antiretroviral naïve patients. The study will enroll 10 antiretroviral naïve~     patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48~     weeks. The combination of these two agents has the potential to be a potent regimen with~     minimal metabolic complications. However, they have not been studied in combination~     previously.~      This pilot study proposes to evaluate this combination in antiretroviral naïve patients to~     document the safety and efficacy of this combination in order to provide clinicians with a~     treatment regimen that minimizes the risk of metabolic complications.~   "
141338|NCT01204879|"~     This study will evaluate the efficacy of an exercise-based contingency management (CM)~     intervention. A total of 120 substance abusing patients in intensive outpatient treatment~     will be randomly assigned to one of two conditions: (a) standard care plus CM for completing~     goal-related activities not related to exercising (e.g., improving work, family, or~     transportation issues), or (b) standard care plus CM for completing exercise-related~     activities. Compared to those receiving goal-related CM activity contracting, it is expected~     that those in the exercise CM condition will participate in more physical activities and~     develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors,~     lessen depressive symptoms, and improve health indices.~   "
141339|NCT01204866|"~     The purpose of this study is to determine if Valortim, or one or more of its selected~     formulation components, induces a wheal reaction when introduced percutaneously.~      Two of 4 subjects dosed in a previous study with a modified formulation of Valortim~     experienced treatment related adverse events which were suggestive of allergic or~     allergic-like reactions. In order to better characterize these reactions and determine if~     they represent allergic or allergic-like reactions to Valortim or one or more of its~     components, skin testing of Valortim and selected components on naïve and Valortim-exposed~     subjects will be performed in this study~   "
141340|NCT01204853|"~     The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were~     demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,~     Canada and Australia. In this study, the safety and efficacy after administrations of~     sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will~     be investigated in Japanese PAH patients.~   "
141341|NCT01204840|"~     The purpose of this study is to determine if growth hormone given 4 weeks before as well as~     during a cycle of in vitro fertilization will improve outcomes in women who have had~     previous failure with IVF treatment cycles using high doses of follicle stimulating~     medications and had a poor response (less than 6 follicles).~   "
141342|NCT01204827|"~     Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver~     enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV~     therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral~     suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes.~     However these do not always reflect the degree of liver impairment or the degree of~     improvement in response to therapy. Sebivo has been accepted in Israel as a first line~     therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage.~     Viral load should decrease by 1 log every 3 months, otherwise patients should be offered~     add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative~     chronic HBV and in order to have homogenous population we will select for our study only~     patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver~     function and specifically the function of the microsomal CYP4501A2. It has been shown to~     correlate with the degree of liver impairment and with clinical outcomes in both acute and~     chronic liver disease. The aim of this study is to determine the utility of the 13C~     Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti~     viral therapy.~   "
141343|NCT01204814|"~     MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the~     prevalence of ARV resistance in the population of women who present to study sites to be~     pre-screened or screened for participation in an HIV prevention trial. To date, a~     comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive~     age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV~     drug resistance mutations among women who test HIV-positive when presenting to screen for~     participation in HIV prevention trials.~   "
141344|NCT01204801|"~     The purpose of this randomized Phase III study is to determine whether preoperative focused~     microwave heat treatment and chemotherapy combined are more effective than preoperative~     chemotherapy alone in the treatment of large breast cancer tumors in the intact breast.~     Combining heat with chemotherapy before surgery might shrink the tumor so that it can be~     removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.~   "
141345|NCT01204788|"~     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts~     them at greater risk for infection. The standard of care for preventing infections is to~     give these patients antibiotic, antifungal, and antiviral drugs during the time that white~     blood cell counts are low. However, many patients still develop infections during~     chemotherapy. Radiated white blood cell transfusions are a standard treatment once a patient~     develops a severe infection.~      The goal of this clinical research study is to learn if giving unirradiated white blood cell~     transfusions early in chemotherapy might delay or prevent infections in patients with~     leukemia. Researchers also want to learn more about the type and severity of any infections~     that do occur.~   "
141346|NCT01204775|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin~     in pediatric patients with type 2 diabetes.~   "
141347|NCT01204762|"~     At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious~     for the treatment of chronic hepatitis B virus infection (CHB)~      Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain~     preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in~     combination with Entecavir(ETV) to patients with hepatitis E antigen-positive~     (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach~   "
141348|NCT01204749|"~     The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is~     superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or~     resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.~      AMG 386 is a man-made medication that is designed to stop the development of blood vessels~     in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process~     called angiogenesis, to obtain a supply of oxygen and nutrients to grow.~   "
141349|NCT01204736|"~     Active elbow extension has significant functional benefits for individuals with tetraplegia.~     The proposed work will provide information to assess how effectively people are using their~     elbow extension tendon transfers, and whether one surgery works more effectively than the~     other. This study will provide recommendations to clinicians about the possibility of~     improving function after surgery using rehab techniques.~   "
141352|NCT01204697|"~     This randomized parallel group study will assess the efficacy and safety of erlotinib~     [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in~     former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer.~     Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or~     4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day~     orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study~     treatment is until disease progression.~   "
141353|NCT01204606|"~     -  The purpose of this study is to compare the efficacy of periarticular injections~          consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with~          the efficacy of periarticular injections consisting of the same amount of~          placebo(isotonic saline) during arthroscopic rotator cuff repair.~        -  Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was~          expected that could reduce postoperative pain and narcotic consumption.~   "
141354|NCT01204593|"~     Primary Objective:~      To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day,~     tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type~     1 Diabetes Mellitus (T1DM).~      Secondary Objectives:~      To evaluate:~        -  The change of hemoglobin A1c (HbA1c) from baseline to week 12~        -  The percentage of patients with HbA1c < 7% at week 12 and week 24~        -  The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12~          and week 24~        -  The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and~          week 24~        -  The incidence of symptomatic hypoglycemias~        -  Adverse events~   "
141355|NCT01204580|"~     Primary Objective:~      To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine~     (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M~      Secondary Objectives:~        1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA~          in type 2 diabetes patients after 8 weeks of therapy~        2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks~          of therapy with Amaryl-M~        3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level~          (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))~        4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of~          therapy with Amaryl-M~        5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change~          after 12 weeks of therapy with Amaryl-M~        6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M~        7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level~   "
141356|NCT01204567|"~     The aim of this study is to evaluate the effect of aerobic fitness training on mental health~     (health-related quality of life),cognitive and physical capacity in older people discharge~     from hospital and to assess if further aerobic training at home enhances the effect.~      Design: Randomized controlled trial conducted at Oslo University Hospital, department of~     Medicine in conjunction with Oslo University College. The subjects will be randomized into~     one intervention group (training group) or one control group.~      Outcome measure:~      Health-related quality of life Physical function Cognitive capacity Physical activity Body~     composition Physical activity level~   "
141357|NCT01204554|"~     The aim of the present study is to assess the microcirculatory changes in the distal part of~     the perforator flap using ICG fluorescence angiography.~   "
141358|NCT01204541|"~     This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.~   "
141359|NCT01204528|"~     To investigate whether treatment with a vitamin-D receptor activator is able to improve~     important markers of cardiovascular risk.~   "
141360|NCT01204515|"~     Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is~     called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common~     and costly health care problems in the US. Some children have pain frequently (recurrent~     pain) while others rarely have pain. The investigators are conducting this study to help us~     answer questions about the causes and treatments, and management of IBS in children.~      The purpose of this study is to find out if there is more than one type of IBS in children.~     If there is, this will be important in deciding the best treatments. The investigators also~     want to learn how children with IBS differ from those who do not have recurrent abdominal~     (stomach) pain.~   "
141361|NCT01204502|"~     Bone marrow or blood stem cell transplantation is used to treat a wide range of~     life-threatening conditions. T lymphocytes carried in the graft have powerful beneficial~     effects and play a vital role in the eradication of leukaemia and in fighting infection, but~     can also damage healthy tissues and cause graft-versus-host disease (GVHD).~      To safeguard against GVHD, the investigators propose modifying T cells to encode a 'switch'~     so that they can be eliminated if problems arise.~      Children receiving half-matched (haploidentical) transplants from a parent are most likely~     to benefit from this strategy. At present these patients receive blood stem cells from a~     parent, but the T cells are removed because the risk of serious GVHD is unacceptable. This~     means that they are much more likely to suffer from life threatening infections or~     experience a relapse of leukaemia. The investigators want to use gene therapy to produce~     safe T cells which can be used to strengthen the transplant and prevent these serious~     complications.~   "
141362|NCT01204489|"~     Study aims to pilot a family-centred tailored nutrition intervention at child welfare~     clinics, targeting the previously observed dietary defaults of Finnish children.~   "
141363|NCT01204476|"~     This phase I trial studies the side effects and best dose of cixutumumab when given together~     with everolimus and octreotide acetate in treating patients with advanced low- or~     intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may~     find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide~     acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine~     cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better~     treatment for neuroendocrine cancer.~   "
141375|NCT01204307|"~     To compare the differential influence of 1st line doublet chemotherapy containing Docetaxel~     versus Pemetrexed on clinical efficacy of Erlotinib as a second line therapy in patients~     with relapsed or progressed non-squamous NSCLC.~   "
141364|NCT01204450|"~     RATIONALE: Drugs such as temsirolimus and valproic acid may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Valproic acid may also stop the~     growth of solid tumors by blocking blood flow to the tumor.~      PURPOSE: This phase I trial is studying the side effects and the best dose of temsirolimus~     when given together with valproic acid in treating young patients with relapsed~     neuroblastoma, bone sarcoma, or soft tissue sarcoma.~   "
141365|NCT01204437|"~     Although approximately 50% of new diagnosis breast cancers are in patients above the age of~     65, elderly people remain substantially under-represented in clinical trials, and therefore~     are under-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of~     breast cancer demonstrated an improved disease-free and overall survival for those treated~     with AC or CMF compared to those treated with capecitabine alone.~      The primary aim of the ICE II trial is to determine the compliance and toxicity of~     epirubicin plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as~     adjuvant therapy in non frail elderly patients.~   "
141366|NCT01204424|"~     The success of dental implants is based on a variety of factors including; surgical~     technique, health of the patient, operator skill and, to a significant part, sufficient bone~     for the placement and integration of dental implants. To that end, the replacement of the~     maxillary posterior teeth have presented a considerable challenge because, after the loss of~     maxillary posterior teeth the quality and quantity of the remaining supporting bone may be~     insufficient to support implants properly or reliably. To overcome the deficiency of~     insufficient vertical bone mass of the maxilla, several surgical techniques have been~     developed to increase available bone mass for the replacement of dental implants by bone~     augmentation.~      The conventional procedure for a sinus lift (Caldwell-Luc procedure) requires preparation of~     a mucoperiosteal flap in the buccal molar region and to cut an oval window in the thus~     exposed bone, without damage to the subjacent maxillary sinus membrane. The procedure is~     very invasive and subjects the patient to great stress as a result of substantial swelling~     and discoloration of up to 10 days, and possibly of pain. This surgical procedure is~     oftentimes referred to as open or classic sinus lift. This technique is fraught with~     many risks and complications because of the limitations of healing potential in the~     maxillary sinus. In spite of these risks many patients undergo this procedure because of the~     strong desire to replace missing maxillary teeth with dental implants.~      An alternative approach to the maxillary sinus from the inferior approach of the alveolar~     ridge utilizing solid cylindrical osteotomes was described by Dr. Summers (crestal sinus~     lift). It is a more conservative approach and is less invasive. It was developed to~     eliminate the risks described above.While this technique is safer, an overzealous use of an~     osteotome during the placement of the regenerative material can result in the perforation of~     the subantral membrane with disadvantages discussed above.~      Dr. Eder has developed an innovative way - the JEDER System - of carrying out a crestal~     sinus lift that substantially reduces the risk of perforating the subantral membrane. This~     minimal- invasive way uses 2 newly developed and successfully patented instruments, the~     Druckkammerknochenfräse DKK and the Sinusvibrationspumpe SVP. Following JEDER Syst. the~     mucous membrane of the mouth is opened from the toothless part of the maxillary crest up to~     the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to~     slightly underneath the maxillary sinus membrane.~      The aim of the study is to assess the efficacy and safety of the JEDER Syst., which was~     already demonstrated in 50 treatment attempts. The results of this study will be used for~     the certification process to enable the declaration of conformity for the market approval.~      The main outcome parameter is the perforation rate of the subantral membrane~     intraoperatively and within 6 weeks after the operation.~      Risk benefit assessment:~      In the present study there will be no additional examinations undertaken compared to~     patients which undergo the conventional procedure. The conventional procedure is associated~     with a risk of membrane perforation and consecutive diseases like infection, swelling and~     pain. All these inconveniences should be avoided by using the JEDER Syst. If the worst case~     scenario - the perforation of the subantral membrane - happens, the conventional method will~     be used. Therefore, the risk-benefit assessment~   "
141367|NCT01204411|"~     The purpose of the study is to determine whether the artesunate-amodiaquine combination is~     effective in treating uncomplicated Plasmodium falciparum malaria in children with severe~     acute malnutrition.~      Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and~     mortality in malnourished children. Malnutrition is known to have a modulating effect on the~     incidence of malaria infections, its severity and effectiveness of treatments. However,~     little data exists on antimalarial drug efficacy in malnourished children.~     Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans~     Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine~     is based on non malnourished children. The aim of this study is to measure the clinical and~     parasitological efficacy in severely malnourished children.~      The study is consistent with the standard WHO protocol for monitoring antimalarial drug~     efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except~     for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of~     being an exclusion criteria. The study will encompass a pharmacokinetic part that will~     provide important information on the absorption of the drug.~   "
141368|NCT01204398|"~     The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in~     the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic~     blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan~     80mg/Amlodipine 5mg in patients with moderate to severe hypertension~   "
141369|NCT01204385|"~     The purpose of the study is to identify the bacterial aetiology of acute otitis media~     episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.~   "
141370|NCT01204372|"~     GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and~     tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line~     chemotherapy in metastatic pancreatic cancer patients.~      The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30~     min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks~     followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for~     three weeks followed by one week of rest.~      Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and~     then at 2 mg/kg over 30 min. for the subsequent infusions.~      Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.~      The patients will be subjected to research for the EGFR, HER2 and KRAS status.~   "
141371|NCT01204359|"~     Iodine 131 (131I） treatment on Graves disease and Graves ophthalmopathy relationship has~     always been the focus of debate. Majority view is that the current treatment does not~     increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos~     is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely~     corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But~     the merger with severe proptosis in patients with Graves , especially infiltrative~     exophthalmos , the application of 131I treatment will induce or aggravate not yet reached~     consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective~     study and visual assessment is not lack of uniform standards, and a variety of factors~     (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also~     interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view~     of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment~     or not, how to dose adjustments, and the use of which required treatment with systemic~     issues such as research, explore treatment exophthalmos reduction and mitigation of~     increased proptosis reasonable treatment of symptoms. To further promote the standardization~     of 131I treatment of Graves disease on basis.~   "
141372|NCT01204346|"~     Mentalisation based treatment (MBT) for young people with co-morbid depression and emerging~     personality disorder will be more effective in a day/inpatient setting than treatment as~     usual.~   "
141373|NCT01204333|"~     Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be~     beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have~     a poor prognosis despite treatment with heparin. Published experience with ET is promising,~     but only based on case series and not on controlled trials.~      Objective: The main objective of the TO-ACT trial is to determine if ET improves the~     functional outcome of patients with a severe form of CVT~      Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized,~     open-label, blinded endpoint (PROBE) trial.~      Study population: Patients are eligible if they have a radiologically proven CVT, a high~     probability of poor outcome (defined by presence of one or more of the following risk~     factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the~     deep cerebral venous system) and the responsible physician is uncertain if ET or standard~     anti-coagulant treatment is better.~      Intervention: Patients will be randomized to receive either ET or standard therapy~     (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase~     within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH~     stroke scale and relevant laboratory parameters will be assessed at baseline.~      Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most~     important secondary outcomes are the mRS, mortality and recanalization rate at 6 months.~     Major intra- and extracranial hemorrhagic complications within one week following the~     intervention are the principal safety outcome. Results will be analyzed according to the~     intention-to-treat principle. Assessment of study endpoints will be carried out according~     to standardized questionnaires by a blinded neurologist or research nurse who is not~     involved in the treatment of the patient.~      Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82~     in each treatment arm) have to be included (two-sided alpha, 80% power).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Included patients may benefit directly from ET. Complications of ET, most~     notably intracranial hemorrhages, constitute the most important risk of the study.~   "
141382|NCT01204216|"~     Prevention of complications in veterans with diabetes depends heavily on assessment of blood~     glucose and HbA1c. The HbA1c is a blood test that measures the exposure of hemoglobin (Hb)~     to a person's average blood glucose over the lifespan of a red blood cell (RBC). The test is~     heavily relied upon as a measure of blood glucose control. It is normally assumed that all~     people (those with and without diabetes) have a narrow range of red blood cell survival. It~     has been recently shown that this is not a valid assumption.~      A more precise test of red blood cell survival, using a biotin label method, demonstrated a~     substantial difference of red blood cell survival among otherwise normal people. There is~     sufficient difference in red blood cell survival to alter the estimate of glycemic control~     from the HbA1c test by as much as 30 per cent. This introduces concern that HbA1c values do~     not mean the same thing in a significant number of people.~      Although the evidence is clear that there is variation in RBC survival among people,~     attributing this variation to differences between individuals depends on answering several~     simple questions which surprisingly remain unanswered: whether RBC survival is stable over~     time within an individual and whether blood glucose control affects its stability.~     Therefore, the goal of the proposed studies is to define these characteristics.~   "
141383|NCT01204203|"~     The primary objective of this trial is to determine the response rate of single agent~     zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria~     and the EORTC tumor response criteria for 18F-FDG PET scans.~   "
141384|NCT01204190|"~     The primary objective of this trial is to examine whether ovulation is suppressed after use~     of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene~     (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones~     produced by your body) will be measured and transvaginal ultrasound examinations will be~     conducted at regular intervals. In addition, the concentrations of the administered hormones~     EE and GSD in blood will be determined in regular intervals.~      With regard to the tolerability of the hormone patches subjects will be asked regularly how~     they feel and blood pressure, pulse and body weight will be determined. In addition, blood~     and urine safety examinations will be conducted at defined timepoints.~   "
141385|NCT01204177|"~     This study investigates the safety and efficacy of the combination therapy with BAY86-9766~     and sorafenib in patients with liver cancer. Safety will be determined by laboratory and~     other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined~     by disease control rate, overall survival, time to progression, response rate and duration~     of response.~   "
141386|NCT01204164|"~     This is a multicenter, open-label, dose escalation Phase 1 study.~   "
141387|NCT01204151|"~     Children with FXS are predisposed to manifesting a particular profile of intellectual~     strengths and weaknesses, including specific deficits in math, visual-spatial skills,~     executive functioning, and social skills. Until now, intensive behavioral interventions have~     not been targeted to syndrome-specific weaknesses. In the present study we will develop and~     evaluate behavioral strategies to aid skill acquisition in children with FXS.~   "
141388|NCT01204138|"~     A Phase II, single institution, double blind, randomized, placebo controlled, cross-over~     study exploring the safety and efficacy apremilast in patients with active RA with~     concomitant use of TNF inhibition. Following a screening period, patients with active~     disease on stable TNF inhibition will be randomized to receive either apremilast or placebo~     for a period of 12 weeks. At the end of 12 weeks patients will be assessed for efficacy~     using the ACR responder index looking for a 20% improvement, then all patients initially~     randomized and treated in a blinded fashion with apremilast will be crossed over to placebo~     while those patients initially randomized and treated with placebo will be crossed over to~     apremilast. Patients will be followed for an additional 12 weeks on treatment to assess both~     safety and efficacy of this combination treatment. Following 24 weeks of active treatment or~     early termination, patients will undergo a 28 day safety visit.~   "
141389|NCT01204125|"~     Primary Objective:~      - to assess the pathological Complete Response (pCR) rate in the breast of patients treated~     in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+~     weekly paclitaxel, and weekly paclitaxel single agent as calibrator.~      Secondary objectives are:~        -  pCR rate in the breast and axilla,~        -  Radiological/clinical objective response rate (ORR), breast conservation rate, disease~          free survival (DFS), and overall survival (OS), in each treatment arm,~        -  Safety profiles of study combinations and of the single agent reference treatment,~        -  Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells~          (PBMC) and any correlation between the biological activity of the study treatment and~          the disease outcome.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell~     lines. Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
141390|NCT01204112|"~     The current study is designed to estimate the effect of rifampin (600 mg orally every 24~     hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy~     volunteers~   "
141391|NCT01204099|"~     Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any~     potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.~      Phase 2: To determine the antitumor activity and safety of PX-866 in combination with~     docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.~   "
141392|NCT01204086|"~     The purpose of this study is to establish the clinical effectiveness of antidepressants by~     pharmacogenomic approach, and to determine the levels of inflammatory factors between the~     baseline and the end point of the study in Taiwanese major depressive disorder (MDD)~     patients.~   "
141393|NCT01204073|"~     This is the first study in which TAK-441 is administered to humans. The patient population~     will consist of adults aged 18 or older who have advanced nonhematologic malignancies and~     for whom standard treatment is no longer effective or does not offer curative or~     life-prolonging potential. Following completion of the dose escalation study, patients will~     be enrolled as part of 2 expansion cohorts.~   "
141394|NCT01204060|"~     Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can~     result in reduced quality of life and difficulties with work and school. Once the disease~     has become established with irreversible changes in the lungs it can be very difficult to~     treat. Severe asthma although less common than mild asthma uses more healthcare resources.~      The objective of this project is to find out how the changes in the lung develop in severe~     asthma. Once this is known then new treatments can be developed to prevent irreversible~     damage to the lungs.~      Volunteers will have substances sprayed up their nose and then samples collected from their~     nose. Levels of proteins and cells can be measured in these samples. This will give an~     indication of the type of inflammation that occurs.~      The usual method of investigating the changes that occur in asthma is to challenge the~     lungs. Samples have to then be collected from the lungs. This can be in the form of sputum~     which must be treated to break it down to a liquid or washed out during a camera test. These~     methods cause problems with measuring proteins and they are broken down or diluted. Because~     the nose is easily accessible samples can be obtained at many time points. Because the~     samples can be collected directly from the nose the problems with obtaining samples from the~     lung are avoided.~   "
141395|NCT01204047|"~     The specific aims of this study are: 1) to assess the test-retest reliability of a~     modification of an existing wheelchair propulsion assessment and 2) validate the~     modification against traditional measures of physical strength, power, and endurance in a~     group of persons with spinal cord injury (SCI).~   "
141396|NCT01204034|"~     The objective of this study is to evaluate the effect of the combination of formoterol and~     beclometasone dipropionate on central and peripheral airway dimensions in COPD patients~     using Computational Fluid Dynamics (CFD). Further more, the effect of this combination~     therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment~     test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.~   "
141397|NCT01204021|"~     There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2~     people from 1970 to 2000. A 40% increase in the number of people living alone is projected~     for 2010. Social isolation is consistently one of the strongest predictors mortality in~     older adults. Recent research is demonstrating that stress plays an important role linking~     social isolation with poor health. Socially isolated older adults are more likely to feel~     chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated~     adults respond to stress differently, both psychologically and physiologically. Socially~     isolated and lonely older adults show long-term elevations in inflammatory cytokines,~     which are signaling molecules related by immune cells. These Inflammatory cytokines play a~     role in a number of age-related diseases including cardiovascular disease, type-2 diabetes~     and arthritis. Novel, readily useable interventions aimed at decreasing isolation and~     re-calibrating stress responses might be helpful to older adults.~      Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases~     feelings of stress and as such, it may be a useful intervention for socially isolated,~     stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih~     (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly~     well-suited for older adults. This proposed study will test the effects of a TCC~     intervention with socially isolated older adults on loneliness, stress and health outcomes,~     including inflammatory assessment. Tai Chi-naïve participants who perceive themselves as~     socially isolated, as measured by the UCLA Loneliness Scale will be randomized to receive~     either Tai Chi or education control for a 12-week period. Subjects will undergo pre- and~     post-intervention stress assessment, including exposure to a psychological stress task, to~     assess whether Tai Chi affects how subjects physiologically and psychologically respond to~     stress.~   "
141398|NCT01204008|"~     Summary: This is a prospective randomize study to compare conservative and aggressive~     discectomy for treatment of disc herniation with radiculopathy.~      Study hypothesis: The investigators believe that conservative discectomy could preserve a~     higher disc space and has a better long-term outcomes.~   "
141399|NCT01203995|"~     The purpose of this study is to provide testing methods of delivering nutrition and physical~     activity services for weight loss.~   "
141400|NCT01203982|"~     The aim of this study was to measure the effect of moderate and intensive lipid-lowering~     treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate~     marker of cardiovascular risk.~   "
141401|NCT01203969|"~     This randomized trial is designed to identify the safety and efficacy of single port~     laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.~   "
141402|NCT01203956|"~     There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when~     using the DeVilbiss AutoAdjust device.~   "
141403|NCT01203943|"~     The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in~     idiopathic pulmonary fibrosis patients.~   "
141404|NCT01203930|"~     This study is to evaluate the safety and clinical activity of idelalisib alone and in~     combination with rituximab in patients with CLL or SLL.~      This Phase 2 study will be the first time that idelalisib is administered to previously~     untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical~     activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity,~     which supports its evaluation in previously untreated patients. The study population is~     limited to patients over 65 years of age because younger patients are generally appropriate~     for standard immunochemotherapy regimens that are highly active. Since the mechanism of~     action of idelalisib is distinct from rituximab, it is hypothesized that the combination~     will be more active than either agent alone. This study will establish initial safety and~     clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL.~     Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in~     subjects with untreated CLL or SLL.~   "
141405|NCT01203917|"~     This study is carried out to see how Caucasian patients with lung cancer which has EGFR~     mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will~     also be collected and analysed to confirm that treatment with gefitinib is safe and well~     tolerated.~   "
141406|NCT01203904|"~     The purpose of this study is to confirm the safety profile for long term treatment in~     children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on~     growth rate. Effect on adrenal function. Development of infection diseases by diseases type.~   "
141407|NCT01203891|"~     The objective of the study is to acquire a database of Single Photon Emission Computed~     Tomographic (SPECT) studies of the brains of normal human subjects in resting and~     concentrating states. The database will provide a basis for subsequent investigation of~     meaningful brain differences between clinical and normal subject groups~   "
141408|NCT01203878|"~     The purpose of this study is to explore the effect of treating actinic keratoses of the face~     with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with~     imiquimod alone~   "
141409|NCT01203865|"~     The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro~     planning resource allocation of medical expenditure as well as for identifying demographic~     and ethnic differences of this unique population compared with other western samples. In the~     current study the investigators aim at estimating the prevalence of fibromyalgia in this~     population. For this purpose a two - stage process will be used. First, a population survey~     will be conducted by telephone, screening for widespread pain and fatigue in the general~     population. This survey will use the London Fibromyalgia Epidemiology Study Screening~     Questionnaire. Second, a sample of patients attending the rheumatology clinic will be~     surveyed with this tool and will be examined in order to determine the actual proportion of~     patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the~     positive predictive value of the London Fibromyalgia Epidemiology Study Screening~     Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the~     population.~   "
141410|NCT01203852|"~     There are many medications available for the treatment of high blood pressure~     (hypertension), but finding the right one for a specific patient can be challenging. In~     fact, it is estimated that less than 50% of people with hypertension have their blood~     pressure under control. The hypothesis is that genetic differences between individuals~     influence their response to antihypertensive medications. This study is aimed at determining~     the genetic factors that may influence a person's response to either a beta-blocker or a~     thiazide diuretic. The hope is that through this research, the investigators may someday be~     able to use an individual's genetic information to guide the selection of their blood~     pressure medicine, leading to better control of blood pressure, and less need for the~     current trial and error process.~   "
141411|NCT01203839|"~     Currently the standard of care is to treat early stage invasive breast cancer or ductal~     carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as~     breast-conserving therapy (BCT). The traditional method of giving radiation therapy after~     a lumpectomy is to the whole breast.~      However the investigators do not know if the whole breast needs to be receive radiation to~     better control your cancer or only a more limited area of the breast surrounding the tumor.~     The purpose of this study is to see the side effects of delivering partial breast~     irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given~     only to the area of the breast where the cancer was removed. Another purpose of this study~     is to look long term at the rate at which cancer comes back in the same breast after PBI.~      WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial~     breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation.~     The investigators propose to deliver the PBI radiation therapy, for a few minutes a day,~     once a day, five days a week, for 2 weeks.~      In this study the investigators will learn about the good and bad effects of PBI radiation~     therapy. In this study, the investigators will also learn about how the breast looks after~     surgery and radiation therapy.~   "
141412|NCT01203826|"~     This clinical trial studies the long term safety and efficacy of asfotase alfa in children~     with HPP who completed the ENB-006-09 study.~   "
141413|NCT01203813|"~     Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be~     substantially improved over 18 months by:~        -  Point of care electronic alerts to primary care physicians recommending~          risk-appropriate care, and~        -  Quarterly mailings to patients providing self management support materials, including~          tailored recommendations based on personalized data from an electronic disease registry~      Aim 2: To assess the relationship between utilization of the intervention components and~     primary care physician attitudes towards both chronic kidney disease management and~     electronic reminder systems.~   "
141414|NCT01203800|"~     In this study the investigators intend to explore the long term significance of BBB~     disruption on the clinical course and the rate of significant recurrent ischemic events in~     patients with a chronic stroke.~   "
141415|NCT01203787|"~     Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting~     at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in~     subjects with unresectable and/or metastatic hepatocellular carcinoma.~   "
141416|NCT01203774|"~     In this study the investigators would like to test the hypothesis that in diabetic patients~     discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected~     Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.~     The investigators will test this hypothesis in a randomized, crossover trial.~   "
141417|NCT01203761|"~     The experience of illness and hospitalization exerts a great deal of psychological distress,~     one of the most distressful events people might experience throughout their life times.~     Surgery and anesthesia with their accompanying loss of control, fear of being unconscious~     and invaded, and expectation of postoperative pain adds appreciably to that stress and~     anxiety.~      Current psycho-physiological research has provided evidence on the alarming possibility of~     the aversive affects of hospitalization stress on the patients' already deteriorated~     physical health and marked interference with their recovery.~      As an additional stressor, which may partly be related to the hospital staff, and partly to~     the person's illness and expected surgery is loneliness.~      Loneliness is a painful experience that is, commonly, not embraced and which has~     consequences that are detrimental to one's emotional, physical and spiritual well being.~      The present study explores the qualitative aspects of loneliness (via questionnaires) in two~     patient populations: (1) patients facing surgery, and (2) patients who have already~     undergone surgery. In addition, family members [i.e. those waiting outside of the operating~     room] will be given a questionnaire, and these three groups will be compared to the general~     population.~   "
141418|NCT01203748|"~     This investigation is designed with the hypothesis that combined PV Antral Isolation and~     Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success~     rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and~     to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.~   "
141433|NCT01203553|"~     Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such~     meshes are mainly implanted via open or laparoscopic approach. The differential impact of~     these two types of surgical technique on recurrence rate will be investigated with this~     study.~      With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia~     repair will be investigated prospectively. Hernia recurrence is the main outcome measure.~   "
141419|NCT01203735|"~     This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent~     chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with~     locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned~     for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and~     oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted~     every 3 months after completion of the study treatment. Toxicity will be assessed using~     CTCAE, based on clinical examination and laboratory tests during the study treatment and at~     follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and~     progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.~   "
141420|NCT01203722|"~     If transplantation using mismatched unrelated donors or non-first-degree relatives could be~     performed with an acceptable toxicity profile, an important unmet need would be served.~     Towards this goal, the current study extends our platform of nonmyeloablative, partially~     HLA-mismatched BMT to the use of such donors, investigating up to several postgrafting~     immunosuppression regimens that incorporate high-dose Cy. Of central interest is the~     incorporation of sirolimus into this postgrafting immunosuppression regimen. The primary~     goal is to identify a transplant regimen associated with acceptable rates of severe acute~     GVHD and NRM by Day 100.~   "
141421|NCT01203709|"~     A trial of combination of two drugs for the treatment of refractory lupus nephritis.~   "
141422|NCT01203696|"~     Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It~     is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood~     sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB)~     is also commonly used for blood pressure and anginal control in these patients.~     Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme.~     There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect,~     but the clinical implication is unclear.~      This study test the hypothesis that there is no significant effect of dihydropyridines CCB~     on clopidogrel response compared with control. After giving consent, patients with~     suboptimal blood pressure or anginal control will be randomized to receive either~     dihydropyridine CCB or non-CCB as placebo. These patient will be follow-up in 1 month.~   "
141423|NCT01203683|"~     The purpose of this study is to determine whether completing a computer-based program alters~     changes how the brain processes emotional information and improves symptoms of depression.~   "
141424|NCT01203670|"~     The aim of the study is to evaluate renal and digestive tolerance of a food supplement,~     phytalgic, on elderly volunteers.~   "
141425|NCT01203657|"~     Although a number of studies have examined the effects of Tai Chi in older adult~     populations, few have methodically assessed its effects on vitality, fatigue and physical~     activity. Some studies have shown that fatigue relates to negative mood and poor~     health-related quality of life in older persons.~      Tai Chi is an ancient Chinese form of calisthenics that utilizes the body's internal energy~     (chi), mind, and breathing; which may be a useful exercise for older adults in increasing~     their activity level. A twenty-four of Yang style of Tai Chi is a simple form of Tai Chi~     that is particularly well-suited for older adults. This proposed study to investigate the~     effects of a Tai Chi intervention on decreasing fatigue level, and increasing level of~     activity in healthy older adults.~      The investigators research group has focused on the Tai Chi as a strategy to reduce stress~     and improve sleep, and their preliminary evidence suggest it strongly affects energy level~     and vitality. The investigators are focused on taking this intervention into the community~     testing its efficacy. The investigators preliminary data shows that Tai Chi is of benefit to~     older adults; however, this study will test whether their research findings are~     generalizable to community settings.~      Tai Chi-naïve participants from Culver City Senior Center will receive a 10-week Tai Chi.~     The investigators will compare this group to a wait-list control group. All subjects will~     receive a packet of questionnaires of pre- and post-intervention vitality, fatigue and~     health-related quality of life. Subjects will also be given an activity monitor to wear for~     2 days before they start the Tai Chi class and for 2 days after they complete the class, to~     determine if there is a change in general physical activity level.~   "
141426|NCT01203644|"~     The primary objective of this study was to determine the appropriate dose of SKY0402 for the~     management of postoperative pain following inguinal hernia repair. This study evaluated the~     safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine~     HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair.~     Study drug was administered by surgical wound infiltration at the end of the hernia repair~     procedure.~   "
141427|NCT01203631|"~     This trial is conducted in Europe and North America. The aim of the trial is to assess~     disease activity and safety in subjects with moderately to severely active Crohn's disease~     (CD) when treated with NNC 0142-0000-0002.~   "
141428|NCT01203618|"~     The purpose of this study is to evaluate whether therapy with farletuzumab is effective and~     safe in the treatment of resectable, non-functioning pituitary adenomas.~   "
141429|NCT01203605|"~     The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study~     of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.~      Participating centres throughout Europe will contribute routine clinical data describing all~     eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will~     then be followed until hospital discharge (or for a maximum of 60 days) for duration of~     hospital stay and hospital mortality. Routine clinical data will also be collected for those~     patients admitted to critical care at any stage after surgery but during the same hospital~     admission. Specific objectives are to describe clinical outcomes and standards of~     peri-operative care for patients undergoing non-cardiac surgery in Europe.~   "
141430|NCT01203592|"~     The study tests the notion that patients suffering from certain types of congenital~     myasthenic syndromes are benefitted by the use of Albuterol at doses used in clinical~     practice.~   "
141431|NCT01203579|"~     The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in~     lung cancer detection and potential health economic outcomes.~   "
141432|NCT01203566|"~     LESS laparoscopic appendectomy is associated with less pain than conventional 3-port~     laparoscopic appendectomy.~   "
141434|NCT01203540|"~     Multicentre, Double blind, Randomized, Comparative Study(comparing~     N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in~     Abak preservative free device.~      Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in~     patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.~      The patients will attend 4 visits.~   "
141435|NCT01203527|"~     The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu~     medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect~     the currently recommended dosage of this medication.~   "
141436|NCT01203514|"~     This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in~     infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether~     early erythropoietin (Epo) and iron therapy would decrease the number of transfusions~     received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin~     (Epo) and iron therapy would decrease the percentage of infants who received any~     transfusions.~   "
141437|NCT01203501|"~     This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in~     extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal~     Research Network Generic Database whose mothers were given prenatal MgSO4, data were~     prospectively collected on maternal/infant conditions and magnesium exposure (including~     indications, timing and duration of exposure).~   "
141438|NCT01203488|"~     This multi-site, randomized trial was conducted to determine the safety and effectiveness of~     a higher dose of vitamin A and determine if this would increase the rate of survival without~     bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights~     from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours~     of age were enrolled. Subjects were randomized to either the Vitamin A or a control group.~     Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on~     Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure~     rather than placebo injections.~   "
141439|NCT01203475|"~     This study was a multicenter, prospective cohort study to define postnatal longitudinal~     growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop~     postnatal growth curves for VLBW preterm infants that would permit an assessment of growth~     velocity; 2) to relate growth velocity and nutritional practices (duration of parenteral~     nutrition, age at first enteral feeding, and age at full enteral feeding); 3) to compare~     growth velocity in infants who are small-for-gestational age (SGA) with infants who are~     appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common,~     major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset~     infection) and necrotizing enterocolitis (NEC). These growth data may be useful in~     identifying preterm infants who are growing slowly despite current nutritional support and~     in designing and performing clinical trials of nutritional interventions.~   "
141440|NCT01203462|"~     The purpose of this study is to determine the effect of probiotic supplemented yogurt in~     reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two~     yogurts will be administered, one containing a specific strain of probiotic in the~     Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized~     that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and~     improved gastrointestinal comfort and quality of life compared to those receiving the~     non-probiotic supplemented yogurt.~   "
141441|NCT01203449|"~     The primary purpose of this study was to evaluate the accuracy of gestational age (GA)~     estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate~     obstetric estimates of GA. Secondary purposes were: (1) to compare the accuracy of GA~     estimates derived from the NBS, the original Ballard score, and the physical items of the~     original Ballard score and (2) to compare these measures of GA and best obstetric estimates~     of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks'~     gestation and among very low birth weight infants in general.~   "
141442|NCT01203436|"~     The purpose of this trial was to determine the efficacy and safety of supplemental~     therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce~     the probability of progression to threshold ROP and the need for peripheral retinal~     ablation.~   "
141443|NCT01203423|"~     This study was an observational study to estimate the prevalence of Persistent pulmonary~     hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory~     disease.~   "
141444|NCT01203410|"~     The objective of this study was to describe total bilirubin production in healthy term~     infants as a means of understanding the differences in jaundice pigment production~     associated with various common clinical circumstances.~   "
141445|NCT01203397|"~     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the~     treatment of superficial varicose veins~   "
141446|NCT01203384|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.~   "
141447|NCT01203371|"~     The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and~     Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of~     patients with benign prostatic hyperplasia.~   "
141448|NCT01203358|"~     The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal~     (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal~     respiratory distress syndrome.~   "
141449|NCT01203345|"~     A controlled clinical trial was conducted at eight participating centers between January 1,~     1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin~     group or a control group. There were two phases to the study (see below). During phase 1 the~     control infants received infusions of placebo. During phase 2 the control infants received~     no infusion therapy.~   "
141474|NCT01203007|"~     The purpose of this study is to assess whether a tailored diet, eliminating antigens to~     which IgA nephropathy patients have demonstrated sensitivity, will have an effect on~     proteinuria, renal function and other immunological variables.~   "
141576|NCT01201655|"~     The purpose of this study is to investigate the impact of splenectomy coupled with~     portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic~     cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope~     to find a new idear and method to prevent or cure HCC.~   "
141450|NCT01203332|"~     The proposed research will include adolescent and young adult Hispanic/Latino men who have~     sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13~     ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial~     services to the target group. In 10 of the 13 sites, comparisons will be made between~     alternative venue-based testing (AVT) and social and sexual network-based interviewing and~     HIV testing (SSNIT) strategies to assess which, among these approaches, is the most~     effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young,~     at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for~     identifying undiagnosed HIV in our target group of adolescents and young adults. All study~     participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV~     screening. Participants with presumptive HIV positive screening results will be referred to~     the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to~     HIV medical care. Linkage to care for ATN 096 study participants will be conducted in~     accordance with the Strategic Multisite Initiative for the Identification, Linkage, and~     Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH)~     Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test~     positive for HIV as part of this protocol are linked with treatment and care.~   "
141451|NCT01203319|"~     This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained~     from the phase 1 clinical trial. The purpose of this study is to further evaluate the~     immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16~     and older who failed to respond to routine administration of 10mcg recombinant hepatitis B~     vaccines and to explore the optimizing immunizing dose and immune procedure.~   "
141452|NCT01203306|"~     Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and~     conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent~     administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic~     properties. Since well differentiated NE carcinomas are highly vascular, there is a~     rationale for testing metronomic chemotherapy and antiangiogenetic drugs. This is a~     national, multicenter, phase II study.~   "
141453|NCT01203293|"~     The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy~     (CBT) based interventions in general health settings that are delivered to reduce~     Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve~     health-related quality of life.~   "
141454|NCT01203280|"~     Most boxing injuries occurs over head and neck which leads to potentially acute or chronic~     head and neck injuries. Patients with whiplash injury has been reported, reflected by~     increased body sway and reduced ability to overcome challenging balance tasks. The purpose~     of this research is to evaluate the fitness and balance outcomes between the boxers and the~     control group, and boxers undergoing posterior-neck icing effects.~   "
141455|NCT01203267|"~     The purpose of this study is to evaluate the pathological complete response (pCR) rate in~     breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.~   "
141456|NCT01203254|"~     The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency~     of soft and liquid stools per day in patients with CD in clinical remission with symptoms of~     BAM and to assess the improvement in stool consistency and quality of life in these patients~     and to assess the safety of cholestagel.~   "
141457|NCT01203241|"~     The aim of the present study is to assess whether left atrial roof ablation adds any benefit~     in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.~   "
141458|NCT01203228|"~     In this trial dose reduced conditioning is compared to standard conditioning followed by~     allogeneic stem cell transplantation from related or unrelated donors in patients with MDS~     or secondary AML.~      Conditioning is the very high dose chemotherapy treatment that is given in the days before~     the stem cell transplant.~      The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality~     from 40% to 20% at one year after allogeneic stem cell transplantation.~   "
141459|NCT01203215|"~     Print-based interventions, specifically interventions that are theoretically-based have been~     shown to be effective for individuals. These types of interventions are of particular~     importance for those individuals who, due to transportation, work, family, social, or~     financial demands have difficulty participating in face-to-face programs. Therefore, we~     decided to test 2 such print based programs for women.~   "
141460|NCT01203202|"~     The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable~     and effective in the treatment of premature ejaculation.~   "
141461|NCT01203189|"~     The aims of this study are to compare the effectiveness of antifungal foam versus antifungal~     shampoo and determine patient compliance and satisfaction with both vehicles among African~     American females with dandruff practicing less than once weekly hair washing.~   "
141462|NCT01203176|"~     The prevalence of endometrial polyp is 24% in the general population but is much higher in~     postmenopausal women. The incidence of malignant or pre-malignant findings in endometrial~     polyps ranges from 2 to 10% in menopausal women.~      Removal of endometrial polyps in postmenopausal symptomatic women is the standard of care,~     same goes for asymptomatic women with risk factors for endometrial malignancy, however~     treatment of asymptomatic postmenopausal women with endometrial polyp but no risk factors is~     disputable.~      In light of ambiguity in literature regarding the rate of malignant and pre-malignant~     findings in polyps in asymptomatic post-menopausal women, the investigators are asking to~     conduct a prospective study in order to evaluate and compare the incidence of malignant and~     pre-malignant changes in symptomatic and asymptomatic postmenopausal women with endometrial~     polyp~   "
141495|NCT01202734|"~     The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of~     Methylphenidate HCl in healthy Japanese adult male volunteers.~   "
141496|NCT01202721|"~     The purpose of this study is to determine whether long-term treatment with a beta-blocker~     (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan,~     given to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the~     widening (dilatation) of the aorta from its baseline size.~   "
141587|NCT01201512|"~     The purpose of study was to characterize using an online questionnaire the feasibility of~     recruiting dentists in primary care dental practices in the practice-based research network~     and documenting their current initial care for their TMJD pain patients.~   "
141463|NCT01203163|"~     Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn),~     oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated~     area (a tear or puncture of the tissue), have been identified in research studies evaluating~     photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease~     or the variation in the occurrence of these adverse reactions among different indications,~     it is difficult to determine the occurrence and frequency of these safety issues in routine~     clinical practice.~      This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT~     using porfimer sodium. A registry allows the collection of data to evaluate real-world~     results in the practice of medicine. The registry will monitor the patient's health and any~     events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the~     treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US~     and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment~     of lung cancer, esophageal [food pipe] cancer, or high-grade dysplasia (HGD) (precancerous~     change in the food pipe tissue) in Barrett's esophagus.~   "
141464|NCT01203150|"~     This hypothesis-driven study will investigate effects of physical activity with or without a~     nutrient supplement known to increase body lean mass in adults with chronic paraplegia who~     have clusters of obesity and obesity-related secondary complications.~   "
141465|NCT01203137|"~     Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were~     suggested as independent prognosticator for predicting long-term prognosis in patients with~     isolated severe TR undergoing corrective surgery We attempted to explore whether early~     postoperative echocardiography provides additional prognostic information on top of~     preoperative clinical and echocardiographic variables.~   "
141466|NCT01203124|"~     The study will investigate how the dose of AZD8848 and the dosing frequency will affect the~     immunological/inflammatory response by measuring the production of biomarkers in blood and~     nasal lavage.~   "
141467|NCT01203111|"~     Primary Objective:~      To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin~     glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week~     24 (visit 10).~      Secondary Objectives:~        1. Percentage of patients with HbA1c < 7% at week 24.~        2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event~          at week 24.~        3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at~          week 0, week 12 and week 24.~        4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose~          / kg (U/kg) will be calculated at week 24.~        5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at~          week 0, week 12 and week 24.~        6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal~          symptomatic, severe and nocturnal severe) will be evaluated during the treatment~          period. 7-Adverse events.~   "
141468|NCT01203098|"~     The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b~     15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after~     elective total hip arthroplasty.~   "
141469|NCT01203085|"~     The primary goal of this project is to develop and test a Charcot Marie Tooth disease (CMT)~     Pediatric Scale for use in evaluation in natural history CMT study.~   "
141470|NCT01203072|"~     The objective of this study is to assess the efficacy, safety and dose-response relationship~     of DU-176b compared with placebo for the prevention of venous thromboembolism in patients~     after elective total knee arthroplasty.~   "
141471|NCT01203046|"~     Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in~     Venezuela. Accidents and violence at Hospital Miguel Perez Carreño along april 2009 were~     represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention~     respectively within a total of 76 cases. Likewise gunshot wounds reach the first cause of~     morbility into general surgery services with 21 cases and the stabbing wounds the 12th cause~     with 12 cases within the same period.~      Early therapy is defined as the antibiotic dose administrated within the first 12 hours~     after the trauma. Abdominal cavity contamination by micro-organism is not synonymous of~     stablished infection, the extension of contamination and intensity of reaction should be~     enough in order to allow the inflammatory focus developing.~      Abdominal cavity needs at least 12 - 24 hours of exposure to the infectious material to~     allow the stablishment of such infection. Origin and amount of contaminant material~     influence the size of inoculated bacteria and the speed that infection develops.~      There is not an absolute criteria to determine when intrabdominal contamination progress to~     an established infection. Surgeons decides the must adequated therapy according to clinical~     history, radiology tests and findings during surgery.~      Selected patients for early antibiotic therapy in penetrating abdominal trauma includes~     those with traumatic intestinal wounds with less than 12 hours of evolution and those with~     gastroduodenal wounds lesser than 24 hours as well.~      There are different antibiotics indicated for intrabdominal infections. Ertapenem is a low~     resistance carbapenem with a broad spectrum into microbial flora presenting in penetrating~     abdominal trauma. Its media life and blood therapeutic levels allows the use of an unique~     dose within the first 24 hours of trauma.~      This research protocol has been designed according to established patterns for clinical~     investigation and our goal is to achieve criteria in decision making about antibiotic~     administration in patients with penetrating abdominal trauma and evaluate the security of an~     Early short term antibiotic therapy with Ertapenem 3 days vs 7 days, decreasing hospital~     costs related to indiscriminate use of antibiotics.~   "
141472|NCT01203033|"~     Treatment options and clinical outcomes for acute myeloid leukemia (AML) have not improved~     for more than 40 years. AML patients are still suffering from receiving costly, ineffective~     chemotherapy treatments with very high chances of bad side effects. The purpose of this~     study is to take a look at leukemia cells to see if the investigators can learn what makes~     them up and makes them aggressive and hard to treat. We want to use this information to~     create new treatments that the investigators hope are more effective and less harmful for~     AML patients.~      Newly diagnosed, relapsed or refractory (post induction therapy) AML patients that are 18~     years of age or older will have bone marrow and blood samples taken for their regular AML~     treatment. When these tests are done during their treatment the investigators will need to~     get some extra blood and bone marrow to do this research. The patients will not be asked to~     have an extra needle stick or bone marrow biopsy to get these samples. The patients will~     have the same number of blood and bone marrow tests whether they participate in this study~     or not. We will only need to get about two teaspoons of blood and two teaspoons of bone~     marrow each time the patient has these tests during their regular AML treatment. The~     research the investigators do with these sample will not decide or change the care the~     patients get for their AML.~   "
141473|NCT01203020|"~     This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)~     followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine~     in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.~   "
141475|NCT01202994|"~     Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the~     United States. AD is characterized by severe impairments in learning, memory and other~     cognitive abilities that significantly interfere with daily functioning. The neuropathologic~     hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal~     cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral~     role in the development of AD. Elevated levels of Abeta in the brain are also correlated~     with cognitive decline.~      Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment~     is most effective when begun during the early stages of the disease. Thus, it has become~     important for researchers to identify markers of early AD. This project will examine the~     relationship between four potential markers that may indicate the early development of AD:~        1. Mild cognitive impairment (MCI)or normal cognition~        2. Practice effects~        3. Amyloid plaque binding on 18F-PIB PET~        4. Glucose hypometabolism on FDG PET~      This project will recruit 25 subjects from an ongoing community-based study of memory and~     practice effects in cognitively normal, community-dwelling individuals who are age 65 and~     over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET)~     with both 18F-Flutemetamol and FDG.~      The overall objective of this companion project is to study the biodistribution and binding~     of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological~     evidence to support the overall hypothesis that failure to benefit from practice on a~     learning paradigm is an early marker of AD.~   "
141476|NCT01202981|"~     This study will assess the impact of IOL glistenings on visual quality and function in~     patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits~     glistening formations. The primary objective is to determine if random light scattering~     (measured by C-Quant)correlates with severity of glistenings, other objective measures of~     visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with~     glare), and subjective measures of patients' perceptions of their visual quality after~     cataract surgery (quality of life survey, reports of symptomology and satisfaction).~   "
141477|NCT01202968|"~     It was well known that long term intubation caused a various kind of abnormal presentations~     of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal~     pathology, the airway stenosis and so on. It was thought that the freezing and impaired~     proprioception to be developed as a result of dis-use around the pharynx and the larynx~     while intubation was one of the reason.~      Preemptive swallowing manual stimulation applied on the oral cavity to avoid the vicious~     cycle of dis-use was reported to improve dysphagia after extubation.~      Neuromuscular electrical stimulation have been utilized for a wide variety of dysphagia of~     multiple causes of neuro-muscular disorder.~      Supposing that preemptive transcutaneous neuromuscular electrical stimulation to be~     delivered to the muscles of being involved in swallowing could decrease the degree of~     dis-use during intubation so that it could reduce the occurence and severity of dysphagia~     developed after extubation, the investigators plan to perform randomized prospective double~     blind placebo controlled clinical interventional study.~   "
141478|NCT01202955|"~     The goals of this within-subject pilot study are: (1) assess the feasibility and safety of~     administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and~     (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms~     that promote relapse. A secondary exploratory goal is to assess whether these effects may be~     more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT~     val/val.~   "
141479|NCT01202942|"~     The proposed research extends previous research on Quest® cigarette smoking behavior by~     testing whether compensatory smoking occurs as cigarette nicotine level decreases, and~     whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested~     in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for~     at least five years and are not currently interested in quitting, but interested in trying a~     new cigarette product. Participants will be randomized to one of three conditions: 1) smoke~     their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively~     decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down~     condition, where they will smoke Quest® cigarettes in a random order. The study will consist~     of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all~     participants, followed by one of the three cigarette conditions. For those smoking Quest®~     cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or~     random fashion. The primary behavioral outcome is smoking topography, a quantitative~     measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of~     smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL~     (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled~     breath condensate will also be collected at the laboratory visits. At the initiation of the~     study, participants will view the Quest® print advertisement and complete a survey related~     to product expectations in order to determine the impact marketing and advertisement has on~     beliefs, attitudes and behaviors related to Quest® cigarettes.~   "
141480|NCT01202929|"~     High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin~     catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the~     esophagus. It includes a sophisticated software to display the pressures data as color~     topography plot using time, length of the esophagus and pressure within the entire~     esophagus. It is unclear if this technology improvement actually correlates with patient's~     symptoms.~   "
141497|NCT01202695|"~     Primary:~      • To compare the safety profile of a single intravenous administration of AVP-21D9 as~     compared with Placebo~      Secondary:~        -  To evaluate the pharmacokinetics (PK) of a single intravenous administration of~          AVP-21D9~        -  To evaluate the immunogenicity of AVP-21D9~   "
141498|NCT01202682|"~     The purpose of this study is to gather ECG data during normal activity, exercise, and sleep~     from normal subjects with or without well-controlled epilepsy. This normal subject data will~     serve as true negative (i.e., no seizure occurring) challenge data for testing cardiac~     based seizure detection algorithms.~   "
141499|NCT01202669|"~     The purpose of this study is to collect continuous observational data during a clinical~     Epilepsy Monitoring Unit evaluation.~   "
142924|NCT01183871|"~     The investigators hypothesize that the lung resection would be associated with lower jugular~     bulb oxygen saturation in patients with severe pulmonary dysfunction than in patients with~     healthy lung functions.~   "
141481|NCT01202916|"~     Congenital heart diseases (CHD) are the first cause of congenital malformations with an~     incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a~     great impact on CHD prevalence. France was the first country to show the impact of prenatal~     diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart~     syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and~     cardiac catheterization have led to lower mortality and morbidity in this population.~     Prevalence of  GUCH , grown-ups with congenital heart disease has thus been significantly~     increasing. For all these reasons and as the investigators can also see in other many~     chronic diseases, new questions about the quality of life of these patients arise among~     patients, parents/future parents, doctors, patients associations, and public health~     organizations. In 2007 French government promoted a national public health plan for~     improvement of the quality of life among patients suffering from chronic illnesses. First~     step of such a program is to correctly evaluate this quality of life. Indeed the concept of~     quality of life (QoL) remains subjective and difficult to appreciate and measure. Its~     analysis requires the use of validated questionnaires. Few questionnaires are available in~     Europe, especially in pediatrics. Few studies in this population have been led and no~     comparative study to a control randomized group has been published. The investigators study~     aims to analyze in the investigators tertiary care center in pediatric cardiology the QoL~     among 8 to 18 year old French patients with CHD using a validated questionnaire (Kidscreen™)~     and to compare it to same aged healthy children. The investigators secondarily intend to :-~     validate the French version of one reference pediatric QoL questionnaire used in most~     publications in the USA (PedsQL™). - compare the QoL to the severity of the CHD using a~     published semi-quantitative score.- compare the QoL to the severity of the CHD using the~     results of routine exercise tests (VO2 max) performed routinely in the investigators center.~     The investigators hypothesis are that :- Quality of life of most common and not severe CHD~     is close to that of healthy children. - QoL of severe CHD is not so well correlated to~     severity of CHD.- PedsQL™ is a simple questionnaire which can be used in France in routine~     follow-up of children with CHD.~   "
141482|NCT01202903|"~     This study will assess the efficacy, safety and tolerability of omalizumab, compared to~     placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic~     asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4~     therapy.~   "
141483|NCT01202890|"~     This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and~     Bevacizumab,and gather preliminary data on the potential activity of the combination in~     patients with platinum resistant/refractory ovarian cancer.~   "
141484|NCT01202877|"~     The goal of this clinical research study is to learn if the combination of PKC412 (also~     called Midostaurin) and 5-azacytidine can help to control refractory or relapsed acute~     leukemia and MDS. The safety and best dose of the combination of the drugs will also be~     studied.~   "
141485|NCT01202864|"~     The purpose of this study is to find risk factors for hemorrhagic stroke, specifically~     intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.~   "
141486|NCT01202851|"~     The goal of this behavioral research study is to compare two different forms of relaxation~     programs that will include stretching and relaxation techniques, in order to learn if and~     how well they may help to improve physical and emotional well-being. This will be tested in~     patients with breast cancer who are receiving radiation therapy. For comparison purposes,~     there will also be a group of participants that does not take part in the relaxation~     programs.~   "
141487|NCT01202838|"~     The purpose of this study is to study composites of bioactive glass and methylmetacrylate~     with glass fibre reinforcement in cranial bone defect reconstruction.~   "
141488|NCT01202825|"~     The purpose of this study is to assess the safety and tolerability of TMC647055 both after~     increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after~     multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as~     well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from~     100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed~     conditions at increasing dose levels administered for 6 days and to assess the effect of~     food on a single oral dose of TMC647055 at one dose level, all in healthy participants. In~     addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055~     will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10~     days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics~     means how the drug is absorbed into the bloodstream, distributed in the body and eliminated~     from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C~     infection.~   "
141489|NCT01202812|"~     The purpose of the study is to determine the effectiveness of LOVAZA (fish oil capsules) to~     decrease inflammation in children and adolescents with Sickle Cell Disease (SCD). It has~     been found that besides the damage caused by sickle red blood cells themselves, the~     inflammatory response that occurs in SCD patients could potentially play a significant role~     in the occurrence of painful episodes or pain crises. The investigators will also study~     whether the subject/caregiver feels that there is an improvement in the child's quality of~     life by taking the medication. Besides the effect of LOVAZA on inflammation,the~     investigators are also testing whether the drug will have a beneficial effect on blood~     clotting ability (which is known to be increased in SCD) and on the anemia (low red blood~     cells) that is part of the disease entity.~   "
141490|NCT01202799|"~     It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac~     administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject~     convenience and compliance with a comparable bioavailability, safety and tolerability~     profile to that of the approved PENNSAID solution administered four times a day (QID).~   "
141491|NCT01202786|"~     The aim of the study is in cancer of unknown primary (CUP) patients, to compare the~     cost-effectiveness of miRview™ mets test with conventional work-up in identifying the~     primary tumor site.~   "
141492|NCT01202773|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in~     the treatment of rheumatoid arthritis in patients with an inadequate response to one or more~     Tumor necrosis factor-alpha (TNF α) inhibitors.~      This study is comprised of 2 periods:~      Period 1 - 24 week blinded treatment~      Period 2 - 48 week post treatment follow up~   "
141493|NCT01202760|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in~     the treatment of rheumatoid arthritis while with or without Background Disease-Modifying~     Anti-rheumatic Drug (DMARD) Therapy.~      This study is comprised of 2 periods:~      Period 1 - 24 week blinded treatment~      Period 2 - 48 week post treatment follow up~   "
141494|NCT01202747|"~     The objective is to evaluate the feasibility of using additional screening methods to~     optimize effectiveness outcomes with the LipiFlow System for application of heat and~     pressure therapy in adult patients with chronic cystic conditions of the eyelids, including~     meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye,~     and chalazia. The screening methods include diagnostic expression of the meibomian glands~     and interferometry assessment of the tear film.~   "
141500|NCT01202656|"~     This a trial designed to test whether granulocyte colony stimulating factor (G-CSF,~     Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer.~     Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that~     intrauterine infusion of G-CSF can improve endometrial development and can increase~     implantation rates of embryos.~   "
141501|NCT01202643|"~     The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in~     women who have failed reaching minimal endometrial thickness by standard treatments, to~     assess how many reach embryo transfer and what implantation and pregnancy rates are in~     comparison to control patients. The study will be conducted in women undergoing transfer of~     previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.~   "
141502|NCT01202630|"~     The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for~     prevention of recurrent Clostridium difficile infection.~   "
141503|NCT01202617|"~     The purpose of the study is to determine whether the Seroquel XR treatment for 6 months~     improves the relapse prevention in schizophrenic outpatients~   "
141504|NCT01202604|"~     The primary objective of the study is to evaluate the efficacy of administered maintenance~     treatments in bipolar disorder I and II, defined as the percentage of patients who~     experience a relapse episode during the first 9 months after a mood event (manic or~     depressive).~   "
141505|NCT01202591|"~     The purpose of this study is to assess the safety and effectiveness of AZD4547 in~     combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1~     polysomy (FISH4/5) or gene amplification (FISH 6)~   "
141506|NCT01202578|"~     The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube~     Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.~   "
141507|NCT01202565|"~     There is clearly a need for further data on the efficacy of biologic agents in the treatment~     of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports~     can be found, but no published data exists from non-interventional studies, such as~     post-marketing observational studies (PMOS) that reflect routine clinical practice.~      The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the~     treatment of nail and scalp psoriatic lesions in routine dermatologic practice.~   "
141508|NCT01202552|"~     One-site dose sparing intradermal influenza vaccination in elderly had been studied but~     resulted in unsatisfactory outcomes. The investigators evaluate the safety and~     immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6~     and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular~     15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age.~     An influenza vaccine administered intramuscularly at the standard dose is used as the~     reference vaccine.~   "
141509|NCT01202539|"~     The purpose of this study is to assess the ability of a modified thermoplastic mask system~     in keeping an individual head stationary for a predefined amount of time. The investigators~     hope to know if the modified mask is study enough, and also if the modification on the mask~     will allow the investigator see and track the individual's movement underneath the mask by~     means of a camera that can detect light reflected from the individual. Participants will lay~     down on their backs and their heads will be held in place with the mask system for~     approximately 1 hour.~   "
141510|NCT01202526|"~     Gastric bypass surgery induces remission of diabetes within days after surgery, before~     significant weight loss. The aim of the study is to examine whether improved insulin~     sensitivity of muscle and liver contributes to the immediate diabetes resolution.~   "
141511|NCT01202513|"~     Vitiligo is an acquired depigmentation disorder of great cosmetic importance, affecting 1-4%~     of the world's population. Phototherapy and topical agents such as corticosteroids,~     calcineurin inhibitors, and vitamin-D derivatives are basic treatment modalities have been~     used in vitiligo but there is still no effective and safe treatment for this disease.~     Resistance to therapy, treatment complications and recurrence after treatment are the major~     problems of the current treatments.~      There are no clinical studies of use of Bimatoprost in treatment of vitiligo, as it is~     supposed to cause more hyperpigmentation and hypertrichosis as compared to other topical~     prostaglandin analogues; hence, the investigators decided to use it in treatment of~     localized vitiligo.~   "
141512|NCT01202500|"~     Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of~     contamination during pregnancy: the parasite can pass through the placental barrier and~     infect the foetus. The severity of congenital infection varies, but in France, where~     maternal seroconversions during pregnancy are treated, the manifestations of the disease are~     often infraclinical at birth and only appear during the first years of life in the form of~     retinochoroiditis. In order to prevent long-term sequellae, children with confirmed~     congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either~     sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has~     not yet been evaluated. Moreover, there is no consensus about the duration of the treatment,~     which varies, in France, from 12 to 24 months depending on the centre. Compared with the~     duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these~     treatments are very long. They are also far longer than the 3 months of treatment, which is~     in accordance with the World Health Organization (WHO) recommendations, given in Denmark to~     infants identified as being infected with the parasite during neonatal screening. A one-year~     treatment was developed in the United States, but it mainly concerns only symptomatic~     children, given the absence of generalised screening in the United States of America (USA).~     We have no arguments to justify the use of treatments lasting one year or more in children~     with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which~     may be severe, notably with regard to haematological or skin conditions, they have to be~     supervised closely with biological tests, which adds further constraints for both the~     children and their parents and increases the cost to health care systems.~   "
141513|NCT01202487|"~     Minor lacerations are a commonly treated injury in the paediatric emergency department .~     Over the past decade, standard closure of these lacerations has evolved from suture repair~     to closure with tissue adhesive (also referred to as skin glue). Local anaesthetic is not~     routinely used during application of skin glue as it was with sutures. There are, however,~     several potential advantages to pre-treating wounds with topical LET~     (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive~     properties. Some believe LET can improve patient comfort, increase the ease of glue~     application, and lead to better healing when used on lacerations being repaired with tissue~     adhesive. This study aims to address the question of whether or not pre-treatment with LET~     improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is~     that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual~     Analog Scale) during repair with tissue adhesive.~   "
141514|NCT01202474|"~     Primary Objective:~      Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in~     patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and~     12 months of treatment~      Secondary Objectives:~      Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per~     patient from the baseline to the end of the study Change in daily dose of glargine and~     glulisine at 6 and 12 months of treatment.~   "
141515|NCT01202461|"~     This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal~     triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.~      Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007~     Oct 15.).~   "
141516|NCT01202448|"~     This study is to evaluate the incidence of central nervous system (CNS) relapse or~     metastasis in patients with diffuse large B-cell lymphoma.~   "
141517|NCT01202435|"~     The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of a~     pregabalin controlled release tablet as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
141518|NCT01202422|"~     The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of~     two pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate~     release capsule and 3) evaluate the safety and tolerability of multiple doses of two~     pregabalin controlled release tablets as compared to multiple doses of the pregabalin~     immediate release capsule.~   "
141519|NCT01202409|"~     The goal of this clinical research study is to learn if panitumumab can help to control~     advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be~     studied.~   "
141520|NCT01202396|"~     Pouchitis is a common complication following proctocolectomy with ileal pouch anal~     anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life~     and can become a chronic problem. The aetiology of pouchitis is not completely understood. A~     crucial role of the intestinal microbiota has been suggested, but no causative agent has~     been identified so far. Furthermore, the defensin expression and the epithelial integrity~     are altered in inflammatory bowel diseases and may play an important role in the development~     of intestinal inflammation. Therefore, it has been hypothesized that the interaction between~     an altered microbiota composition, a defective epithelial integrity and changes in innate~     defense parameters such as defensins has a pivotal role in the development of pouchitis in~     UC patients.~   "
141521|NCT01202383|"~     The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to~     determine if the impact of treating water with chlorine at the household level is effective~     in preventing diarrhea among young children. For more than a century, chlorine has be used~     to treat water in municipal systems in developed countries. Lack of infrastructure has~     prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been~     used for more than 30 years in emergencies and has recently been approved for routine~     treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo~     will consist of the food-grade ingredients in the effective tablet, without the chlorine.~     Study participants will be supplied with tablets (intervention or placebo) and instructed to~     use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea~     morbidity and weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality~     of water stored in the home will be measured each month. The study will also assess the~     impact of the intervention on absenteeism from school and work and on health care~     expenditure for diarrhoea.~   "
141522|NCT01202370|"~     Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While~     seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents,~     inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation~     cogeners are hampered by a labile α-hydroxy-δ-lactone pharmacophore, which hydrolyzes to~     yield the inactive carboxylate form of the drug. AR-67~     (7-t-butyldimethylsilyl-10-hydroxycamptothecin) is a third generation analog engineered to~     be stable in blood and highly potent. Its enhanced stability results from two factors: (1)~     AR-67 is highly lipophilic, partitioning into lipid bilayers, thus protecting it from~     hydrolysis in the aqueous milieu of the bloodstream, and (2) the 10-hydroxy functionality of~     the drug effectively ablates the high affinity interactions of the carboxylate drug form~     with albumin, which has been previously shown to diminish the levels of the active lactone~     species in the circulation. In a recently completed phase I trial, AR-67 showed over 85%~     lactone stability at all time points studied, and was well-tolerated with grade 4~     thrombocytopenia, neutropenic fever and grade 3 fatigue as dose limiting toxicities. The MTD~     was established at 7.5 mg/m2/day in a daily times five of a 21 day cycle. Preclinical data~     indicates that AR-67 may concentrate in tumors for a prolonged period of time, compared to~     plasma clearance of the drug, a phenomenon which has the potential to improve efficacy and~     decrease toxicity of this compound. What is not known is the optimal dose and schedule of~     AR-67 needed to produce high tumor penetration, and modest systemic exposure. This pilot~     proposal seeks to study AR-67 in a novel dosing schedule and to evaluate the feasibility of~     performing tumor biopsies to determine the tumor half-life of AR-67 in humans. By using~     multiple tumor biopsies, as a means to document penetration of tumor tissue by AR-67, and~     compare that to plasma clearance of the drug, the investigators will establish direct~     pharmacokinetic evidence that AR-67 hits the target. The investigators propose that a~     rigorous evaluation of drug penetration into the tumor should be considered, in addition to~     the MTD, when determining dose of new experimental compounds. Dose-tumor concentration~     relationships should be established early in the course of clinical development to provide~     data for rational selection of the phase-II dose. This pilot study will provide important~     preliminary data to establish the feasibility of this approach for future study. If~     successful, tumor half life will be used to develop an optimal biologic dose in a phase I~     trial using this schedule of AR-67. Optimal biologic dosing could become a new standard for~     dose escalation studies with this compound and other cytotoxic drugs that have specific~     biologic targets in the future.~   "
141523|NCT01202357|"~     A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case~     management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving~     an additional year of case management, or (2) terminating case management for the next 12~     months. The current study aims to investigate whether an additional year of case management~     in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms,~     quality of life and health economics.~   "
141550|NCT01202006|"~     The purpose of this study is to determine whether a structured diagnostic-therapeutic~     strategy to detect and treat previously unrecognized (or unestablished) heart failure in~     primary care will improve the functional capacity, quality of care, the quality of life, and~     eventually the prognosis of these patients.~   "
141524|NCT01202344|"~     The purpose of this study is to develop a computer program that might be able to accurately~     assess the risk of artery re-narrowing following angioplasty or stenting based on computer~     images. After angioplasty (a procedure to re-open narrowed or blocked blood vessels) the~     patients will have extra images taken in order to assess the results of the procedure; which~     will then be used to see whether or not these images can help predict outcomes such as the~     patient having to come back to the hospital to have the procedure done again.~   "
141525|NCT01202331|"~     Mass antimicrobial administrations have been remarkably successful in reducing the~     prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions~     progressively lower the prevalence of infection, and in some cases may even result in local~     elimination. Mass treatments cannot be continued forever, due to concerns about cost and~     antibiotic resistance. The hope has been that other measures such as latrine construction~     and hygiene programs would prevent infection from returning. Unfortunately, no~     non-antibiotic measure has yet demonstrated an effect on infection.~        1. We hypothesize that Chlamydial infection will return to communities when treatment~          ends.~        2. We hypothesize that infection will be completely eliminated in all communities treated~          for seven years.~        3. We hypothesize that identifying and treating clinically active cases among preschool~          aged children will delay or even prevent reemergence at a far lower cost than mass~          treatment of all individuals.~   "
141526|NCT01202318|"~     This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and~     Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911~     call suggestive of stroke.~      The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS)~     will improve the diagnostic accuracy of emergency medical dispatchers for stroke.~   "
141527|NCT01202305|"~     HIV medicines have led to dramatic improvements in health. However, there remains a concern~     for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition,~     research has found that health is not completely restored in HIV-infected patients, even if~     they have been taking effective HIV medicines for a long time. This may be due to direct~     drug-toxicity, continued replication of the virus, and/or inflammation of the body in~     response to the virus. Therefore, a more complete understanding of how HIV stays in the body~     is necessary.~      Recent research has shown that one of the places that HIV can stay in the body is in~     lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines~     for a long time). In addition, the amount of damage to the lymphatic tissues can predict how~     the immune system (CD4+ T cell count) will respond to therapy.~      The investigators therefore propose a study in which lymph nodes from the groin area will be~     removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much~     damage has happened to the lymph node architecture.~   "
141528|NCT01202292|"~     The overall goal of IMOAP study is to assess whether the efficacy of the healthcare~     professionals' usual practices, together with a motivational group intervention (delivered~     by a nurse trained by an expert psychologist), is more effective than an isolated~     traditional intervention on weight loss and its maintenance in overweight and obese~     patients. Furthermore, the study will evaluate whether this result has a positive impact on~     quality of life, changes in eating habits, and a reduction in the associated cardiovascular~     risk factors and overall cardiovascular risk.~   "
141529|NCT01202279|"~     The purpose of this study is to determine if treatment with Mucinex D lowers the use of~     antibiotics in the treatment of upper respiratory infection when compared to placebo~   "
141530|NCT01202266|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers~   "
141531|NCT01202253|"~     The purpose of this study is to describe the real world effectiveness of anidulafungin in~     clinical practice in a large Liver Unit in the United Kingdom.~   "
141532|NCT01202240|"~     Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on~     the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and~     eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy~     volunteers.~   "
141533|NCT01202227|"~     The purpose of this study is to assess the safety of the long-term use of pregabalin at~     doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury~     pain, post stroke pain, and multiple sclerosis pain).~   "
141534|NCT01202214|"~     The purpose of this study is to describe the safety and tolerability of single and repeat~     oral doses of GSK1440115 in healthy volunteers.~   "
141535|NCT01202201|"~     The purpose of this study is to evaluate the epidemiology and baseline disease burden of~     rotavirus gastroenteritis in children < 6 years of age, in Japan.~   "
141536|NCT01202188|"~     The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in~     patients with moderate to severe COPD.~   "
141537|NCT01202175|"~     The investigators aim to evaluate subjects at high risk of future development of~     hypertension, those with a family history of hypertension and/or that already have high~     normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to~     investigate whether these subjects have the same markers (such as microscopic protein in the~     urine or C-reactive protein in the blood) in the blood and urine that people with high blood~     pressure have, and whether they are improved before and after taking the beta-blocker~     nebivolol.~   "
141551|NCT01201993|"~     The investigators hypothesis is that a significant number of patients may remain without~     specific cause and have recurrent syncope with its associated physical and mental morbidity.~   "
141552|NCT01201980|"~     This study is aimed to evaluate response rate of the antihypertensive treatment with a~     calcium antagonist in real life practice, to evaluate patients' quality of life and to~     collect the following Serbia-specific epidemiology data on hypertension: demographic data,~     patents characteristics, and patients' management/treatment.~   "
141577|NCT01201642|"~     The aim of this study is to compare the effects of prednisolone and staging acupuncture in~     the recovery of the affected facial nerve, and to verify that whether in combination with~     staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large~     number of patients.~   "
143801|NCT01172379|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of E2007~     in Parkinson's Disease patients who have wearing off motor fluctuations and on period~     dyskenisias.~   "
141538|NCT01202162|"~     Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a~     rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that~     Desflurane can reduce the extubation time when compared to Sevoflurane. This potential~     benefit of Desflurane can be especially attractive in short ambulatory cases performed with~     general anesthesia with a laryngeal mask airway.~      Although some studies have not shown a difference on perioperative cough and laryngospasm~     between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the~     literature that Desflurane causes cough4 and many providers avoid using Desflurane with a~     LMA (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate,~     as a secondary outcome, the presence and severity of perioperative cough and laryngospasm.~      Previous investigators have demonstrated a more rapid resumption of normal daily activities~     after ambulatory surgery in patients anesthetized with Desflurane when compared with~     Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is~     used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality~     of recovery as a secondary outcome using a validated instrument.~      Significance:~        1. A more rapid awakening, especially, in a fast and high turnover cases that are~          performed with LMA can lead to a more cost effective utilization of operating room time~        2. It has been reported that Desflurane causes more cough than Sevoflurane and~          Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that~          there is no difference.~   "
141539|NCT01202149|"~     This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic~     dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus)~     cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects with atopic dermatitis. Subjects~     will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target~     eczematous area located on one side of the body and then apply Hylatopic™ Plus Emollient~     Foam™ three times daily on a symmetrical target eczematous area on the opposite side of the~     body. A randomized list will be created to determine which side the subject applies each~     medication.~      Subjects will be consented prior to any study evaluations or procedures. After signing the~     consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will~     apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected~     areas for four weeks. Photography will be used to record the location of target lesions at~     the baseline, week two and week four/final visits. Subject's disease status will be assessed~     by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score~     (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0),~     week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of~     the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of~     skin atrophy and telangiectasias will be noted at each study visit as well.~      Additionally, subjects' self-assessments of their perception of degree of disease and~     itching severity control will be collected at each visit for each target lesion. This~     assessment will be made using a four point scale and Itch Severity Scale (visual analogue~     score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference~     Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate~     Product Preference Surveys for subjects that are younger than 12 years of age.~   "
141540|NCT01202136|"~     The aim is to propose and prospectively validate a diagnostic approach and model for~     prediction of mucinous versus non-mucinous, and malignant versus non-malignant pancreatic~     cysts using a combination of clinical, radiologic, and biomarker characteristics.~   "
141541|NCT01202123|"~     The purpose of this study is to evaluate the safety and efficacy of highly purified (HP)~     menotrophine to Korean women.~   "
141542|NCT01202110|"~     The primary objective of this study is to determine in patients with traumatic brain injury~     (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia~     (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or~     decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive~     to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the~     number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to~     treatment that occur without propranolol.~   "
141543|NCT01202097|"~     The primary objective will be to compare the formulations regarding their impact on the~     pulmonary function of persistent asthma patients and the secondary objective will be the~     clinical control of the disease's symptoms.~   "
141544|NCT01202084|"~     The primary objective will be to compare the impact of the study formulations on pulmonary~     function in persistent asthma carriers.~   "
141545|NCT01202071|"~     The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10~     mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily~     for 5 days to healthy adult male Japanese participants. This was a single-center,~     open-label, randomized, four-treatment, four-way crossover study.~   "
141546|NCT01202058|"~     As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II~     trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this~     trial started interventional, the remainder of the study will be observational.~      The objective of this prospective, observational study is to ensure the safety and the~     wellbeing of subjects treated with the NEVO™ SES.~   "
141547|NCT01202045|"~     The purpose of this study is to assess the value in terms of sensitivity, specificity and~     likelihood ratio of the stress echocardiography in the screening of pulmonary arterial~     hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial~     hypertension.~   "
141548|NCT01202032|"~     This is an open-label, multicenter dose-escalation phase I study using a 3+3+3 design (i.e.,~     3 to 9 patients per dose level) in patients with mRCC or others advanced refractory solid~     tumors. Enrolment will be performed to include approximately ½ of patients with mRCC.~      The primary endpoint is the occurrence of limiting toxicities leading to definitive~     discontinuation of the study drugs during the first 24 weeks in absence of progression of~     the disease.~      Secondary endpoints included the occurrence of Dose Limiting Toxicities (DLTs) evaluated~     during the first two cycles; overall response rate, 6-months progression-free survival rate~     and Pharmacokinetic assessments.~   "
141549|NCT01202019|"~     This study is designed to assess the impact of exercise and supplementation on measures of~     fitness, function, and cardiovascular disease risk factors/modifiers in individuals with~     spinal cord injury (SCI). The primary purpose of this study is to improve fitness and~     function, reduce cardiovascular disease risks, and enhance oxidation of dietary and body~     fats in persons with chronic tetraplegia through acute exercise, exercise conditioning, and~     dietary supplementation. This study will test the hypothesis that timing of supplementation~     with regards to exercise bout ('intervention/placebo') affects fitness, function, lipid~     profiles, lipid oxidation, and inflammatory markers after acute exercise and chronic~     conditioning.~   "
141553|NCT01201967|"~     For this trial, the investigators propose a prospective trial of a collaborative care~     program to identify and treat depression, generalized anxiety disorder, and panic disorder~     among patients admitted to the hospital for an acute cardiac illness (acute coronary~     syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for~     depression/generalized anxiety disorder/panic disorder will begin in the hospital, and~     ongoing management will continue for six months following discharge.~      The investigators hypothesize that this model will lead to increased treatment rates,~     improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population.~     If this model is effective, it could be implemented clinically to provide better and more~     complete care to patients hospitalized with acute cardiac illness, for whom depression and~     anxiety may be a risk factor for complications and death.~      This will be a two-arm, single-blind randomized controlled trial, with one-half of patients~     randomized to collaborative care and one-half randomized to the control condition (usual~     care). Psychiatric treatment in the intervention arm will be provided in concert with~     patients' primary care physicians—with primary care physicians prescribing all~     medications—within a framework supervised by a psychiatrist.~      The investigators will enroll patients who have any (or all) of the three included~     psychiatric diagnoses to improve the utility of the intervention. The investigators have~     chosen to enroll patients with several different cardiac diagnoses. This will allow the~     researchers to include patients with heterogeneous diagnoses and illness severity to~     determine if our intervention is effective in a broad population of patients with heart~     disease. The investigators will study an intervention targeting depression, generalized~     anxiety disorder, and panic disorder: all three disorders are disabling and associated with~     adverse cardiovascular outcomes, treatments for the conditions are highly similar, the~     investigators can treat patients who have more than one disorder, and a prior outpatient~     program successfully simultaneously addressed more than one mental health condition.~      The project will involve: (1) screening patients for depression, generalized anxiety~     disorder, and panic disorder as part of usual clinical care, (2) evaluation of~     positive-screen patients by a study social work care manager, (3) a multicomponent~     in-hospital intervention (for collaborative care patients) that involves patient education,~     specialist-provided treatment recommendations, and a goal of in-hospital treatment~     initiation, and (4), after discharge, continued phone-based evaluation and care coordination~     with primary care physicians to provide stepwise treatment in the collaborative care arm.~     The intervention has been designed to be low-cost, low-burden, and easily generalizable to~     other settings.~   "
141554|NCT01201954|"~     Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of~     preterm infants during endotracheal suctioning.~   "
141555|NCT01201941|"~     The objective of this study is to compare the effects of a web-based laboratory information~     system (e-Chasqui) between a network of health establishments with access to e-Chasqui~     (intervention group) and a network of health establishments without access to e-Chasqui~     (control group).~      The specific aims are:~        1. To compare the laboratory turn-around-time (from the date a culture or drug~          susceptibility test (DST) result is obtained to the date the result is obtained at the~          health center) of samples pertaining to health establishments in the intervention~          versus the control group.~        2. To compare the clinical turn-around-time (from the date the DST result is obtained to~          the date the patient is evaluated by a physician in possession of that result) among~          multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments~          in the intervention versus control group.~        3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST~          results) between health establishments in the intervention versus control group.~        4. To qualitatively assess the acceptability and usability of e-Chasqui among users in~          health establishments with access to the system.~      The investigators aim to test the following hypotheses:~        1. The laboratory turn-around-time for health establishments with e-Chasqui access will be~          smaller than that for establishments without e-Chasqui access.~        2. The clinical turn-around-time for patients pertaining to health establishments with~          e-Chasqui access will be smaller than that for patients in establishments without~          e-Chasqui access.~        3. Health establishments with e-Chasqui access will have fewer errors compared to those~          without e-Chasqui access.~        4. Factors associated with acceptability and usability of e-Chasqui by systems users can~          be identified.~   "
141556|NCT01201928|"~     The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in~     interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100~     Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the~     course of the parent study.~   "
141557|NCT01201915|"~     This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent)~     operable basal cell carcinoma of the nodular subtype.~   "
141558|NCT01201902|"~     The purpose of this study is to assess the safety and the body's immune response to an~     experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will~     enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or~     vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than~     or equal to 65 years of age.~   "
141559|NCT01201876|"~     The purpose of this study was to document the reasons for replacement or repair of defective~     restorations (fillings) and to record the restorative material of the failed restoration~     and the material used in the replacement restoration on permanent (adult) teeth.~   "
141560|NCT01201863|"~     The purpose of this study is to: Address 3 short term objectives; (1) Determine the effects~     of physiologic testosterone (T) therapy on neurological function and functional independence~     following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation;~     (2) Document the natural history of neuroendocrine dysfunction and recovery in men during~     inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel~     assessment of neurological function for use in the TBI population; and two long-term~     objectives: (1) Utilize study findings to design a multicenter trial to further assess the~     impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management~     with new information about neuroendocrine dysfunction after TBI and hormone treatments to~     improve outcomes.~   "
141561|NCT01201850|"~     This study is being done to learn about the safety of the study drug bevacizumab(Avastin®),~     when used to treat radiation necrosis.~      The primary objective of this study is to test the feasibility of treating Central Nervous~     System (CNS) tumor patients suffering from radiation necrosis with bevacizumab every 2~     weeks.~      The secondary objectives of this study are:~        -  To evaluate improvement in neurologic symptoms associated with bevacizumab as assessed~          by clinical evaluation;~        -  To investigate the neuro-imaging changes in radiation necrosis associated edema,~          including Mass Resonance (MR) spectroscopy;~        -  To evaluate changes in corticosteroid use in patients with radiation necrosis following~          treatment with bevacizumab;~        -  To evaluate changes in quality of life.~   "
141562|NCT01201837|"~     Cardiovascular disease remains the most pressing healthcare issue for developed countries~     and is becoming so for developing countries. There are a number of chronic therapies~     available for long-term management of risk. Short term therapies for subjects with an acute~     event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and~     removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at~     a different site. There are no approved therapies that can rapidly reduce the burden of~     unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions~     that could lead to atherosclerotic plaque stabilization, such as rapid removal of large~     quantities of cholesterol from the vasculature, improvement in endothelial function,~     protection against oxidative damage and reduction in inflammation. This study will assess~     the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque~     progression and regression as assessed by intravascular ultrasound (IVUS) measurements in~     patients with (ACS).~   "
141574|NCT01201681|"~     The purpose of this study is to identify pre-operative factors that put patients at greater~     risk of developing severe tooth pain following root canal therapy, thereby providing~     evidence that will allow dentists to act preventively to lessen this risk, improve pain~     control, increase their patients' quality of life, and decrease the number of dental~     emergency interactions.~      A parallel goal of this study is to assess the feasibility of recruiting dentists that~     provide root canal therapy and patients using the DPBRN.~   "
141563|NCT01201824|"~     Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are~     usually found accidentally as discrete well emarginated pulmonary lesions found within the~     lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic.~     Most solitary lung nodules are benign; however these nodules can represent early stage lung~     cancer. The identification of malignant pulmonary nodules is important because they~     represent a potential form of curable lung malignancy. Every lung nodule should therefore be~     investigated for the possibility of malignancy.~      Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of~     using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few~     studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules.~     The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies,~     ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also~     been shown to be able to locate nodules not visualized on spiral CT.~      The use of intracavitary ultrasound has been suggested by many authors as a safe and~     effective method for localizing hard to find nodules. It is a real time technique with no~     associated complications, low cost, and has the potential to save operative time. Most~     importantly, it may be able to prevent conversion of VATS to open operations in cases where~     nodules are not visualizable or locatable using VATS techniques.~      The use of intracavitary US as a localization method by surgeons intra-operatively could~     lead to better identification of nodules. Also, this technique could avoid performing~     multiple procedures on patients (CT guided targeting followed by surgery) and therefore is~     more cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be~     used routinely during VATS procedures, increasing the chances of finding and localizing~     pulmonary nodules using minimally invasive techniques.~   "
141564|NCT01201811|"~     The primary purpose of this study is to determine the effectiveness and safety of~     azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome~     (MDS).~   "
141565|NCT01201798|"~     The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4~     times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the~     treatment of endogenous anterior uveitis.~   "
141566|NCT01201785|"~     Since diabetic platelets are characterized by an enhanced turnover rate, it may be~     hypothesized that an increase in the frequency, rather than the dose, of drug administration~     may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this~     may enable COX-1 blockade of newly generated platelets. However, how different dosing~     regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has~     been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate~     how increasing the frequency of aspirin administration, remaining within the daily~     recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with~     coronary artery disease.~   "
141567|NCT01201772|"~     A higher degree of platelet inhibition remains the goal of peri-interventional and long-term~     anti-thrombotic therapy in patients with coronary artery disease. In clinical practice,~     patients undergoing percutaneous coronary intervention with stent implantation who are~     already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior~     observations showing that higher inhibition of platelet aggregation may be achieved by~     giving a loading dose of clopidogrel in patients with coronary artery disease while on~     chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of~     platelet aggregation can be achieved by adding a prasugrel loading dose in patients on~     chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a~     prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be~     useful.~   "
141568|NCT01201759|"~     The overall study objectives are to examine whether:~        1. Persons with spinal cord injury (SCI) having elevated body mass are at greater~          cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and~          vascular inflammation than persons with SCI having 'normal' body mass, and~        2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks~          associated with fasting and postprandial lipidemia, glycemia, and vascular~          inflammation.~   "
141569|NCT01201746|"~     Currently the research issue in establishing the role of periodontal disease (PD) in~     coronary heart disease (CHD) risk is to define the pathways that lead to cause-effect~     relationship between PD and CHD. There is no consensus on definition of a periodontal~     disease case or the threshold level that may give clear indication for this relationship.~     Periodontal therapy has been used in different studies with the hope that a change in~     periodontal disease status may modify the factors associated with CHD risk. Many of these~     studies, on role of periodontal therapy in the reduction of CHD associated risk-factors,~     were based on small study samples, and very few studies were randomized controlled trials.~     So a need for large prospective studies is warranted in literature.----------- A~     single-blind parallel-arm randomized controlled clinical trial was designed to observe the~     influence of periodontal treatment on serum inflammatory mediators of hsC-reactive protein,~     white blood cells and fibrinogen in CHD patients.~      Hypothesis: Periodontal therapy in CHD patients, by reducing periodontal inflammation, may~     decrease the host systemic inflammatory burden associated with atherogenic processes.~   "
141570|NCT01201733|"~     The purpose of this study is to evaluate the immediate effect of traditional Thai massage on~     brain electrical activity in the patients with scapulocostal syndrome~   "
141571|NCT01201720|"~     The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on~     albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic~     patients with acute-on-chronic liver failure.~   "
141572|NCT01201707|"~     The study is being done to determine if venous angioplasty is an effective treatment for~     chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or~     blockages are present in the internal jugular or azygos veins (veins which drain blood from~     the central nervous system) and these blockages may be associated with symptoms classically~     attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with~     CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the~     effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two~     groups of patients: one group with CCSVI diagnosed on a venogram and treated with~     angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients~     enrolled in this study, and the neurologist evaluating patients after the procedure, will~     not know whether or not they were treated with angioplasty.~   "
141573|NCT01201694|"~     The goal of this clinical research study is to find the highest tolerable doses of~     surface-controlled water dispersible curcumin (curcumin) that can be given to patients with~     advanced cancer. The safety of this drug will also be studied.~   "
141575|NCT01201668|"~     The purpose of this study is to document by survey the occurence of tooth pain present 3~     months and 6 months after root canal therapy in the patients recruited for the DPBRN~     Peri-operative tooth pain study. This study will access the feasibility of obtaining 3~     month and 6 month follow-up data on the patient enrolled in the DPBRN Peri-operative tooth~     pain study.~   "
141578|NCT01201629|"~     Overall goal of this study is to determine if transcranial direct current stimulation (tDCS)~     plus conventional occupational therapy improves functional motor recovery in the affected~     arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional~     occupational therapy, and to obtain information to plan a large randomized controlled trial.~   "
141579|NCT01201616|"~     A previous study has found that the consumption of a high fat, low carbohydrate meal results~     in increased feelings of calmness, friendliness and an increase in subjective energy levels~     in comparison to a low fat, high carbohydrate meal. The purpose of this study is to~     investigate whether a high fat, low carbohydrate diet for a longer duration (of 2 weeks) can~     enhance or sustain these changes in comparison to a low fat, high carbohydrate meal.~   "
141580|NCT01201603|"~     The aim of this study is primarily to investigate the ability of antioxidants found in~     orange juice (OJ) to increase the body's sensitivity to the hormone insulin. Overweight or~     mildly obese women, who are otherwise healthy, will be recruited. The time commitment for~     subjects is ~14wks. Subjects will attend the laboratory on 5 occasions after fasting from~     midnight. The 1st is a medical screening. Laboratory visits 2 & 5 will take ~5hrs and will~     be separated by 3 months, during which time subjects will consume 250ml of an orange drink~     (either OJ or an orange flavoured control drink) once a day. During visits 2 & 5, subjects~     will have a scan to assess their %body fat using a low-dose x-ray machine, and have their~     insulin sensitivity measured using a technique called a 'Glucose Clamp'. During the 3hr~     glucose clamp, subjects receive an infusion of the hormone insulin and a glucose solution~     directly into their blood stream, with insulin sensitivity determined from the amount of~     glucose required to maintain blood glucose at normal levels. In addition, a small sample of~     fat tissue (about the size of a haricot bean) will be taken from underneath the skin of the~     belly. Subjects will record their food intake for 3-days in weeks 3, 7 and 11 of consuming~     the drink, and come to the lab for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat~     measurements taken in the 1st (screening) visit.~   "
141581|NCT01201590|"~     The aim of the current study is to investigate the ability of antioxidants found in cocoa~     ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or~     mildly obese women, who are otherwise healthy, will be recruited. Subjects will attend the~     laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening,~     with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume~     a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects~     will record their food intake for 3-days before visit 2 and in week 3 of consuming the~     cocoa. They will also eat a diet of standard macronutrient composition for 3 days before~     visits 2 and 3. During the 5 hour laboratory visits, subjects will have a scan to assess~     their body composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry;~     DEXA), and have their insulin sensitivity measured using a 3 hour hyperinsulinemic,~     euglycaemic Clamp.~   "
141582|NCT01201577|"~     It has recently been discovered that bacteria are able to communicate using specialised~     molecules known as Quorum Sensing Signalling Molecules (QSSMs). An accumulation of QSSMs in~     their surrounding environment allow for the bacteria to quantify the size of colonies. At~     specific colony sizes the concentration of QSSMs reaches a critical threshold leading to the~     activation of genes that cause an infection. It is by this mechanism that bacteria within a~     colony coordinate behaviour to activate infectivity when colony sizes are large enough to~     withstand defensive measures from the host's immune system. A disruption of quorum sensing~     may reduce the severity of infection and this has led to the development of inhibitors of~     quorum sensing as a new strategy in antibacterial therapy.~      QSSMs are also thought to facilitate infection by other mechanisms and are able to influence~     the number and function of a specific type of immune cell known as an 'antigen presenting~     cell'. These cells are pivotal in allowing the immune system to recognise components of~     bacteria as foreign and thereby mount the appropriate response. It was found that large~     numbers of these types of cells underwent programmed cell death (cell suicide) in the~     presence of QSSMs compared to when QSSMs were absent. This mirrors the situation in blood~     sampled from patients with severe infections where there is a greater proportion of cell~     deaths among antigen presenting cells than other types of immune cell.~      This study aims to establish in healthy volunteers, the mechanisms by which QSSMs affect~     immune cells and facilitate the spread of infection. Antibiotic administration in humans can~     alter the environment of the intestine and can lead to an overgrowth of harmful bacteria to~     potentially cause an infection. Probiotics supplements can prevent bacterial overgrowth and~     potentially reduce infective complications. The mechanism, which we aim to clarify, may~     involve changes in both the production of QSSMs and the function of immune cells.~      Hypothesis~        1. Antibiotic use alters gut flora, leading to the appearance in the systemic circulation~          of bacterial QSSMs and changes in immune function of the host.~        2. Probiotics and/or prebiotics have beneficial effects by preserving the normal resident~          gut flora, thereby, modulating bacterial QSSMs and preserving the immune function of~          the host.~      Aims~      The aims of our study are 2 fold:~        1. Firstly, to study the effect of orally administered antibiotic on QSSMs (in faeces and~          blood) and on innate and adaptive immunity in healthy humans.~        2. Secondly, to study the effect of orally administered combinations of prebiotic,~          probiotic and antibiotic on QSSMs (in faeces and blood) and on innate and adaptive~          immunity in healthy humans.~   "
141583|NCT01201564|"~     This study is designed to compare two techniques for operative care of umbilical hernia in~     adults regarding wound complications, wound side fluid collections, recurrence rate,~     postoperative pain, duration of hospitalization and quality of life. The IPOM technique~     provides mesh positioning directly into the abdominal cavity onto the defect under~     laparoscopic control while in sublay position the mesh is placed directly behind the rectus~     muscle after small incision close to the belly button.~   "
141584|NCT01201551|"~     It is already known that the local treatment with Alphagan eye drops (a drug commonly used~     by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the~     vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a~     prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this~     effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD).~     To test for the effect of these drugs on PVD and non-PVD subjects the investigators will~     take measurements of corneal temperature as surrogate for ocular blood flow.~   "
141585|NCT01201538|"~     Acoustic Neuromas (otherwise known as Vestibular Schwannoma -VS) are benign tumors which~     grow on the hearing nerve and can cause progressive hearing loss and compression of vital~     brain structures and even death if it continues. The primary objective of this study is to~     evaluate the efficacy of Nilotinib in the treatment of patients with progressing VS.~     Secondary objectives of this study is to evaluate the toxicity profile, quality of life and~     symptom management of Nilotinib in the treatment of patients with progressing VS.~   "
141586|NCT01201525|"~     Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser~     treatments.~      Study design: Prospective single blinded within patient controlled randomised trial. Recent~     surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be~     treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will~     serve as a within patient control. 1 and 6 months after the intervention both parts of the~     scar will be evaluated.~   "
141588|NCT01201499|"~     Inadequate pain control after abdominal procedures may lead to adverse postoperative~     outcome. Epidural analgesia is currently an accepted technique in abdominal surgery, but its~     use has been limited in liver resections by postoperative coagulation disturbances and the~     possible increased risk of bleeding complications, including spinal hematoma. A range of~     alternative analgesic techniques can be used for major liver or pancreatic resections,~     including intrathecal morphine (single shot) administered immediately before surgery, and~     continuous administration of intravenous (IV) short-acting opioids, such as remifentanil,~     plus a single bolus of IV morphine. Postoperatively analgesia may be obtained by~     patient-controlled morphine analgesia (IV PCA). Both protocols have been demonstrated to~     provide satisfactory postoperative pain relief, and each has its unique advantages. However,~     to this end there is no data in the literature to show benefit from one regimen over the~     other. We therefore wish to determine whether there is a difference in analgesic efficacy~     between the two techniques, as optimizing perioperative pain relief in this rapidly~     expanding surgical field is of utmost importance. Our hypothesis is that continuous~     intraoperative IV analgesia with remifentanil followed by IV PCA morphine is not inferior to~     intrathecal morphine with respect to analgesia and ambulation outcome, and may provide an~     alternative, non-invasive intraoperative analgesic technique.~   "
141589|NCT01201486|"~     To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at~     a routine fetal scan in the second trimester of pregnancy~   "
141590|NCT01201473|"~     The purpose of this study was to study the use of a Core Questionnaire that included several~     questions from each PBRN (DPBRN, PEARL, PRECEDENT - collectively know as CONDOR) that had~     been extracted from questionnaires previously administered as part of their initial research~     program activities. This protocol was the first administration of this core questionnaire~     with the purpose of assessing dental practice changes that may have occured since the~     earlier administration of the individual questions with the separate networks.It also~     collected baseline data for others.~   "
141591|NCT01201460|"~     The principal goal of this study was to assess the feasibility of plasma glucose testing in~     private dental practice. A second aim was was to assess prevalence of plasma glucose~     abnormalities in dental patients seen by (DPBRN) practitioner-investigators.~   "
141592|NCT01201447|"~     The purpose of this study was to investigate the process involved when making decisions~     about the diagnosis and treatment of questionable lesions, as well as determine if there is~     any association between lesions progression (or depth, if opened) and clinical~     characteristics and baseline risk assessment.~   "
141593|NCT01201434|"~     Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic~     treatment. These factors taken together with high sputum viscosity and slow motility of the~     gastrointestinal tract-may change the pathogenicity and consistency of the intestinal~     pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens.~     A pilot study performed by the researchers using probiotics in CF patients showed a decrease~     in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled~     trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and~     sputum inflammatory markers in CF patients.~   "
141594|NCT01201421|"~     The purpose of this study was to administer two questionnaires. The first, a Dental~     Satisfaction Questionnaire to assess patient satisfaction with a restoration visit using~     patients recruited from practices participating in the Dental PBRN Reasons for replacement~     or repair of dental restorations study. The second questionnaire (completed by the~     practitioner) was a brief single page questionnaire to evaluate the patient visit.~   "
141595|NCT01201408|"~     The purpose of this study is to assess the quality and expected lifespan of fillings~     recorded in the DPBRN Reasons for placing the first restoration on permanent tooth~     surfaces study, and the factors affecting how long the fillings last.~   "
141596|NCT01201395|"~     The purpose of this study is to assess the quality and expected lifespan of fillings~     recorded in the DPBRN Reasons for replacement and repair of dental restorations study, and~     the factors affecting how long the fillings last.~   "
141597|NCT01201382|"~     This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent~     Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in~     adolescents. The project will: (1) identify adolescents with elevated depressive symptoms~     but who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible~     adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms,~     depressive disorders, global functioning, interpersonal functioning, comorbid conditions and~     school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-,~     18-, and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various~     domains of functioning at each time point; and (5) conduct analyses to examine potential~     mediators and moderators of the association between IPT-AST and depression outcomes. This~     study will yield data on the efficacy of IPT-AST relative to GC for the prevention of~     depressive symptoms and depressive disorders. It will also provide information about the~     mechanisms of action of IPT-AST and determine for whom IPT-AST is most effective.~   "
141616|NCT01201135|"~     Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and~     sideroblastic anemia were found to express very high levels of serum GDF15, and this~     contributed to the inappropriate suppression of hepcidin with subsequent secondary iron~     overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in~     patients with Sickle cell disease and hereditary spherocytosis~   "
141617|NCT01201122|"~     The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa~     compared with twice daily in children with mild to moderate active ulcerative colitis.~   "
141618|NCT01201109|"~     The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel~     release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after~     surgery.~   "
141619|NCT01201096|"~     The purpose of this study is to show the tumor free long term survival of patients with~     isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio~     receptor treatment and following liver transplantation.~   "
141834|NCT01198249|"~     This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among~     anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study~     provides useful information to develop a new fixed dose combination drug.~   "
141598|NCT01201369|"~     Despite recent advances in stent technology and clot reducing drug therapy, acute stent~     occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown~     that certain features of how the stent relates to the artery wall may predict ST. One such~     feature, so-called stent strut malapposition (SSM), can be assessed after implantation but~     current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is~     a newer technology that can be performed safely and easily after angioplasty and may allow~     the stent struts to be assessed more accurately and reliably.~      This study will use OCT to examine how two different types of commonly used drug-eluting~     stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner~     struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore~     that the potentially more pliable structure of the Xience V stent will be associated with~     greater contact with the vessel wall. This may have a bearing on the relative rate of SSM,~     although large studies have shown the rate to be low in both the Cypher and the Xience V~     stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after~     angioplasty will compliment conventional visual assessment and may identify those patients~     in whom further improvement of stent with a balloon is necessary.~      This study will involve the random allocation of forty patients requiring coronary~     angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the~     usual manner as indicated clinically and will include imaging of the stented artery segment~     with OCT once the operator is satisfied with the visual result by angiography.~   "
141599|NCT01201356|"~     The purpose of this study is to collect long-term safety and tolerability, long-term~     efficacy, and health outcome data in all patients currently ongoing in the fingolimod~     multiple sclerosis clinical development program. This study will combine all currently~     ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned~     studies into one single long-term extension protocol that will provide patients with~     continuous treatment and will continue until fingolimod is registered, commercially~     available, and reimbursed in the respective countries.~   "
141600|NCT01201343|"~     This study is planned to evaluate emotional disorders during treatment by interferon (IFN)~     beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label~     exploratory study with no change of therapeutic behavior but with standardized~     neuropsychologic follow-up.~   "
141601|NCT01201330|"~     The purpose of this study was to determine the prevalence of ONJ in the patient population~     of 2 large HMOs and study the risk factors associated with the development of this~     condition.~   "
141602|NCT01201317|"~     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days~     treatment in patients with painful diabetic polyneuropathy.~   "
141603|NCT01201304|"~     This study compares the relative efficacy of three methods of delivering interoceptive~     exposure for the reduction of elevated anxiety sensitivity. The interventions vary according~     to their intensity and use of coping strategies during exposure. An expressive writing~     intervention serves as an expectancy control.~   "
141604|NCT01201291|"~     Aim of the study is to investigate the impact of two different fractions of inspired oxygen~     (FiO2) on outcome in patients with severe traumatic brain injury (TBI).~   "
141605|NCT01201278|"~     This study is designed to compare the safety and tolerability of two different doses of~     intranasally administered regular human insulin with those of a single dose of the~     rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to~     safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters~     will be evaluated by means of the euglycemic glucose clamp technique.~   "
141606|NCT01201265|"~     This multicenter study will assess the efficacy and safety of bevacizumab in combination~     with gemcitabine and cisplatin as first line treatment in participants with triple negative~     metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg~     intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an~     area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study~     treatment is until disease progression.~   "
141607|NCT01201252|"~     The purpose of this study is to estimate the disease burden and epidemiology of rotavirus~     gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute~     gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book~     and stool samples will be collected from all suspected and confirmed acute gastroenteritis~     cases.~   "
141608|NCT01201239|"~     To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with~     other antiretroviral drugs in treatment-experienced Chinese HIV-infected patients, including~     those with multi-drug resistant HIV-1 infection or drug intolerance.~   "
141609|NCT01201226|"~     The purpose of this study to obtain ovarian cortical fragments from perimenopausal patients,~     who undergo pelvic organ surgery and test whether treatment with PTEN inhibitor and PI3K~     activating peptide would induce these fragments to produce FSH responsive follicles in the~     nude mouse model.~   "
141610|NCT01201213|"~     A need exists to define the best local anaesthetic and technique for pain relief in early~     labour. We suggest that calculating the molar Median Effective Dose 50 (ED50) for~     bupivacaine, levobupivacaine and ropivacaine given both by the intrathecal (as a combined~     spinal epidural (CSE)) and epidural routes would provide a valid comparison between the pain~     relieving properties of all three drugs, from which a reasoned assessment of side effects~     can be made.~   "
141611|NCT01201200|"~     The purpose of this study is to determine whether patients with obstructive sleep apnea have~     any changes in right ventricular function evaluated by three dimensional echocardiography.~   "
141612|NCT01201187|"~     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children~     with ADHD~   "
141613|NCT01201174|"~     In the present study the investigators are going to explore the oxidative status of HS-RBC~     and its contribution to hemolysis~   "
141614|NCT01201161|"~     The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative~     vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving~     its anatomical and functional results in patients with advanced proliferative diabetic~     retinopathy and traction retinal detachment.~   "
141615|NCT01201148|"~     This study will investigate whether using oscillating TES (random noise stimulation) or~     intermittent tDCS will have greater antidepressant effects in depressed subjects, compared~     to standard tDCS.~   "
141620|NCT01201083|"~     Specific Aim 1: Identify drug use patterns and partnership dynamics that mediate risk~     behaviors over time in a cohort of recently HIV infected men and their partners.~      Specific Aim 2: Determine predictors of transmission risk within partnerships of recently~     HIV infected men and their partners, using the partnership as the unit of analysis.~      Specific Aim 3: Quantify the long-term population-level impacts of voluntary behavior change~     by men with recent HIV infection, through the use of dynamic mathematical modeling that~     integrates our data on behavior change with current estimates of temporal infectiousness~     patterns. The investigators will also determine whether more frequent testing and/or~     development of tests with earlier sensitivity may have a significant impact on the epidemic.~     Finally, the magnitude of this effect to that obtained by decreasing drug use or risky~     sexual behavior prior to or following seroconversion will be compared. This will be~     conducted as a statistical analysis by co-investigators at the University of Washington.~   "
141621|NCT01201070|"~     General and specific objectives of the search: evaluate the effects of the administration of~     Antithrombin III (ATIII) on the activation of the coagulation system and of the~     fibrinolysis, platelet function, inflammatory response and markers of organ damage in~     patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels~     of post-operative Antithrombin (AT).~   "
141622|NCT01201057|"~     The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of~     bacterial vaginosis.~   "
141623|NCT01201044|"~     The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced~     NSCLC.~   "
141624|NCT01201031|"~     Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial~     pathogen of health-care associated infection since 1988. Although the new antimicrobial~     agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the~     treatment of VRE, but there was not appropriate drugs for eradicating the colonization of~     VRE. So the active surveillance and strict contact precaution are the best methods for VRE~     colonization and transmission.~      This is a one year study program, we select a unit as the study site. First month (January)~     is the prepare period. Therefore , we collect 3 months (from February to April) baseline~     data, then interrupted one month(May) for the health care worker's infection control~     education.~      Then the intervention period are three months (from June to August), and the last four~     months(from September to December) are the analysis and evaluation period. In the baseline~     period, we only do the patient's active surveillance and environmental culture. In the~     intervention period, beside the patient's active surveillance and environmental culture, we~     add contact precaution as the infection control method. If patient has VRE infection, we~     prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.~      The aim of this study is to compare and analyze these two period (baseline period and~     intervention period) for understanding the transmission, risk factors and carriage rate of~     VRE, as the important guidelines for the VRE infection control in the future.~   "
141625|NCT01201018|"~     The study will be non randomized, open label, dose rising study in cancer patients. Cancer~     treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be~     administered orally.~      The study will include two sessions:~        -  A single dose period to evaluate acute toxicity of each drug~        -  Consecutive multiple increment dose escalation period of both drugs to determine the~          long-term safety, and the anticancer activity.~   "
141626|NCT01201005|"~     Premature birth and low birth weight implies insufficient intrauterine growth and fetal~     malnutrition. During the first months of life where the infant is breastfed, the low stores~     aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants~     with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months~     infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile~     for cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin~     treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or~     placebo treatment according to infant biochemical status and neurodevelopment.~      Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency~     will normalize biochemical status and cause improved motor neurodevelopment.~   "
141627|NCT01200992|"~     This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be~     conducted in approximately 120 investigational sites worldwide. Subjects with either~     recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible~     for participation in this study.~      Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG,~     T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or~     without maintenance/re-treatment at 3 months.~      Recurrent disease is defined as reappearance of disease after achieving a tumor-free status~     by 6 months following a full induction course of BCG with or without~     maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred~     within 18 months following the last dose of BCG.~      Approximately 450 subjects will be randomized. The primary objective of this study is to~     evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment~     of subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the~     safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG~     recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction,~     Maintenance and Follow-Up and will be conducted over 3 years.~   "
141633|NCT01200914|"~     Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two~     areas of particular problems are the terminal portion of the cephalic vein near the shoulder~     and the central veins in the chest. Although angioplasty is standard of care the treated~     narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your~     dialysis access functional. Recently there has been introduction of a new technology called~     a covered stent graft. Initial studies suggest that placing this device across the area of~     narrowing leads to dialysis access staying open longer and needing less angioplasty~     treatments.~      This study is designed to compare angioplasty (standard of care) versus using a covered~     stent graft. The investigators will then look at the dialysis records and future~     fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months~     after the initial procedure.~   "
142447|NCT01190111|"~     This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7~     (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of~     4 cycles within 21 months and a maximum of 3 cycles within 12 months.~   "
141628|NCT01200979|"~     Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that~     would facilitate fetal tolerance and result in an increased susceptibility to infection.~     Although the suppression has been characterized as a global T-cell defect, the observation~     that the increase in susceptibility is restricted only to specific intracellular bacteria~     and viruses is consistent with a down regulation of only certain components of the innate~     immune system. Progress in the treatment and management of infections during pregnancy will~     require further understanding of the changes to the immune system that occur during~     pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate~     immune system that occurs during pregnancy and remains until delivery and that changes in~     serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To~     that end, this study will evaluate blood samples drawn from pregnant women during early,~     mid, and late pregnancy and post-partum for changes in the innate immune system and compare~     them to those of healthy, non-pregnant women. Changes in the cytokine profile and in the~     lymphocyte and natural killer (NK) cell populations will be identified. A comparison of any~     observed changes will be made with those previously reported for in vitro and in vivo~     studies....~   "
141629|NCT01200966|"~     Background:~      - Essential tremor (ET) is a neurological disorder involving uncontrollable shaking, which~     over time can interfere with mobility and affect routine aspects of daily living. Several~     medications are used to treat ET, but these medications are often only partially effective~     and can have side effects. About two-thirds (66%) of people with ET have some relief from~     drinking alcohol, which suggests that alcohol affects the part of the brain causing the~     tremor. However, more research is needed to better understand the effects of alcohol or what~     areas of the brain might be important in the response.~      Objectives:~        -  To study to what extent alcohol is reducing tremor in a group of patients with~          essential tremor.~        -  To use transcranial magnetic stimulation to study the effects of alcohol on essential~          tremor.~      Eligibility:~      - Individuals who are at least 21 years of age, have been diagnosed with essential tremor~     and have tremor in both hands, and can tolerate being off all medications for essential~     tremor for up to 4 weeks.~      Design:~        -  This study has one screening visit (1 to 2 hours), followed by one study visit (3 to 5~          hours). Participants might be asked to also take part in one additional study visit (3~          to 5 hours). The maximum period between the study visits is 3 months.~        -  Participants will be screened with a medical history, physical examination, and blood~          tests. At this visit, participants will receive information about how to safely taper~          off their current ET medications before the start of the study.~        -  Participants must be willing to abstain from drinking any alcohol or caffeine (or~          consuming foods with caffeine such as chocolate) for at least 2 days before the study~          visits. Participants must also fast overnight (for at least 8 hours) before the study~          visits.~        -  At the first study visit, participants will receive a single drink of alcohol (mixed~          with a noncaffeinated drink) and will complete movement tests to determine whether the~          alcohol improves the tremor. Alcohol levels will be monitored throughout the visit.~        -  At the second study visit, participants will have an electrocardiogram to measure heart~          electrical activity and determine if they are able to safely have transcranial magnetic~          stimulation. Participants will then receive an intravenous infusion of alcohol and~          complete questionnaires during the infusion to provide information about its effects.~          Then, transcranial magnetic stimulation will be used to study brain electrical~          activity, as well as muscle movements and tremor activity, while under the influence of~          the alcohol infusion.~        -  After each study visit, participants will remain at the clinical center until the~          effects of the alcohol have worn off. Participants will be able to resume taking their~          ET medications after the end of the study.~   "
141630|NCT01200953|"~     Background:~      - Increased clinical attention has been paid to the evaluation and management of~     bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases~     (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However,~     evaluation and treatment data for these illnesses are often limited because human infections~     to date have been relatively limited. Further knowledge about diseases of bioterrorism~     concern and emerging infectious diseases may lead to more effective forms of therapy to~     prevent disease-related illnesses and deaths.~      Objectives:~      - To apply standardized, documented, and carefully monitored evaluation and treatment~     methods for bioterrorism- and biodefense-related illnesses and emerging infectious diseases~     at the National Institutes of Health Clinical Center.~      Eligibility:~        -  Individuals at least 2 years of age who have confirmed or suspected infection by a~          biodefense or bioterrorism agent, or an emerging infectious disease agent.~        -  Individuals at least 2 years of age who have confirmed or suspected exposure to a~          biodefense or bioterrorism agent, an emerging infectious disease agent, or who have~          close exposure to an individual who is suspected of being infected with one of these~          agents.~        -  Health care workers who are involved in medical treatment of the abovementioned~          infected or exposed individuals.~      Design:~        -  All eligible persons will have an initial screening evaluation to determine the~          circumstances of possible infectious exposure (e.g., where, when, and how exposed),~          current medical condition and medical care given, and any aspects of medical history~          that might be relevant to the exposure.~        -  Participants may be seen in an outpatient clinic or in the Special Clinical Studies~          Unit (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward~          specially designed to minimize the risk of spreading infection to others.~        -  Upon admission, participants will provide blood and urine samples, have an~          electrocardiogram to measure heart activity, and have specific tests or procedures~          associated with the particular infectious agent.~        -  Participants who develop illnesses will be treated with the standard of care for known~          diseases or with experimental measures, depending on the nature of the illness.~          Separate consent may be required for these treatments.~        -  Participants will remain on this study for at least 1 year following the period of~          active evaluation and treatment. Participants may be asked to come to the NIH~          outpatient clinic on a periodic basis for medical evaluations and blood tests, and may~          be asked to keep a diary card to record any unusual signs or symptoms of possible~          infection.~   "
141631|NCT01200940|"~     Background:~      - Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in~     products such as diet soft drinks. Recently, researchers learned that these sweeteners may~     affect hormones in the body, especially when they are consumed in combination with real~     sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite,~     and weight. Researchers are interested in studying the effects of artificial sweeteners on~     the metabolism and hormonal levels of healthy volunteers.~      Objectives:~        -  To study the effects that artificial sweeteners have on hormone levels, blood sugar,~          and appetite.~        -  To evaluate whether artificial sweeteners change the rate at which food passes out of~          the stomach into the gut, or the rate at which the body absorbs sugar from the gut.~        -  To evaluate the effects that different amounts of artificial sweeteners have on hormone~          levels.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  This study will require one screening visit and four testing visits, scheduled on~          different days.~        -  At the screening visit, eligible participants will be screened with a physical~          examination, medical history, blood samples, and body measurements (including height,~          weight, body circumferences, and skin folds). Participants will also be asked about how~          much artificial sweetener they typically consume and will have taste tests, in which a~          small amount of flavored liquid is placed on the tongue and participants will name the~          flavor and rate its intensity.~        -  Participants will have four glucose tolerance tests on four different days. In~          preparation for the test, participants will not eat or drink anything but water for 12~          hours prior to the test. Blood will be drawn before the test, and participants will~          drink one of the following study liquids, selected at random:~        -  Plain water~        -  Water mixed with sucralose (the amount found in one 12 oz diet soft drink)~        -  Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)~        -  Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)~        -  Ten minutes after drinking the study liquid, participants will have a sugary drink that~          will allow researchers to measure sugar absorption and the speed with which food leaves~          the stomach.~        -  In addition, participants will complete questionnaires about hunger levels before~          drinking the sugar solution and at regular intervals for 2 hours afterward. Blood~          samples will be taken at regular intervals as well.~   "
141632|NCT01200927|"~     The overall goal of this research is to understand the mechanisms underlying the development~     of postural control in sitting using new methodology, in order to provide a scientific basis~     for evaluation and treatment of posture and movement disorders in infants with cerebral~     palsy. The development of early posture control remains poorly understood despite~     considerable therapeutic effort. Infants with cerebral palsy show their first delays in the~     acquisition of sitting, with subsequent problems developing adequate posture and movement~     control. Identifying the delay, determining the nature of the problem, and evaluating the~     effectiveness of treatment quickly, are vital in the early part of an infant's life, since~     this is the time of greatest plasticity. Tools from nonlinear dynamics, which are~     increasingly being used to examine other biological rhythms, are used in this study to~     analyze postural sway from center of pressure data during the development of sitting~     postural control.~   "
141874|NCT01197703|"~     The European Cardiac CT Registry has the unique potential to provide important data that~     will help to clarify the clinical role of cardiac computed tomography (CT), to create~     guidelines and recommendations for its use, and to identify the most important areas that~     require specific further research.~   "
141634|NCT01200901|"~     In summary, the investigators propose to integrate fMRI assessments within a clinical trial~     of quetiapine XR in patients with melancholic depression in order to test the predictions~     that:~        1. quetiapine XR treatment will be effective and safe for patients with major depression~          with melancholic features~        2. successful treatment with quetiapine XR will be associated with normalization of limbic~          areas associated with increased salivary cortisol response to a stressful task as well~          as normalization on the emotional faces task differences in the melancholic group~          compared with healthy volunteers.~        3. successful treatment with quetiapine XR will be associated with normalization of the~          salivary cortisol response to the stressful math task (i.e. there will be a diminished~          post-treatment mean AUC for cortisol secretion after the stress task compared to the~          pre-treatment AUC values in the patient group)~   "
141635|NCT01200888|"~     The objective of the study is to implement a new method of performing chest CT imaging in~     young children with cystic fibrosis at Packard Children's Hospital. This technique will be~     used to evaluate early lung disease comparing quantitative chest CT air trapping and airway~     measurements with lung function measurements in infants, toddlers, and young children with~     chronic lung disease.~   "
141636|NCT01200875|"~     Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think~     it may enhance athletic performance. However, there is very little published research to~     support or undermine this point of view. The purposes of this study are: (1) To assess the~     effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors~     with suspected or known performance-enhancing effects; and (2) To understand whether the~     effect of PRP therapy on these growth factors differs between intramuscular and~     intratendinous PRP injections.~      This research study is looking for 40 people who are receiving platelet-rich plasma therapy~     for a tendon or muscle injury. The study involves collecting seven blood samples (2~     teaspoons each) from each patient, before and after the PRP treatment. Blood samples may be~     donated at any location of the patient's choosing, and participants will be paid for their~     time.~   "
141637|NCT01200862|"~     This study is designed as a 2-part study, with Part 1 being open-label to best determine the~     appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo~     controlled design. The study aims to assess the safety and tolerability of BGS649, and~     determine whether or not BGS649 is able to normalize testosterone levels and improve insulin~     sensitivity in obese, hypogonadotropic hypogonadal (OHH) men~   "
141638|NCT01200849|"~     The overall objective of this study is to test the efficacy of an evidence-based, enhanced~     Rx container label design to improve Spanish speaking patients' understanding of~     instructions for use.~   "
141639|NCT01200836|"~     Background:~      - The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people~     with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect~     the immune system and reduce inflammation, but the reason for this effect is unclear.~     Researchers are interested in testing the effect of rosuvastatin on the immune systems of~     healthy volunteers with good cholesterol levels.~      Objectives:~      - To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.~      Eligibility:~      - Healthy individuals at least 18 years of age who have an acceptable blood level of LDL~     cholesterol (below 160).~      Design:~        -  Participants will be screened with a medical history and physical examination, as well~          as blood tests to check general health, cholesterol levels, liver function, and the~          C-reactive protein (which responds to inflammation).~        -  Participants will not be permitted to take most prescription and over-the-counter~          medications that affect the immune system, including antihistamines and certain pain~          relievers. For 1 week before the study, participants will have a wash-out period~          without any of these medications.~        -  Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure~          consistent blood sample results).~        -  Participants will provide blood samples at the following time points: (1) immediately~          before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3)~          after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.~   "
141640|NCT01200823|"~     Background:~      - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is~     conducting a variety of laboratory research experiments that require blood, bone marrow,~     urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic,~     autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated~     samples will be sent to the CHI laboratory at the National Institutes of Health to be used~     in research that may provide more information on the changes in the immune system caused by~     these specific disorders.~      Objectives:~      - To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue~     samples from patients with immune-mediated and inflammatory diseases, as well as from family~     members, for ongoing exploratory research studies.~      Eligibility:~        -  Individuals at least 2 years of age who have been diagnosed with an immune-mediated or~          inflammatory disease, or have signs or symptoms of an immune or inflammatory disease~          without a formal diagnosis.~        -  Immediate family members (parent, child, sibling, grandchild) of the above mentioned~          individuals.~      Design:~        -  Participants will be screened with a complete medical history, physical examination,~          and blood and urine samples.~        -  Participants will provide blood, urine, stool, cheek swab, and tissue samples as~          required by the study researchers.~        -  Participants who have immune or inflammatory diseases will also provide blood and bone~          marrow samples collected through biopsies and leukapheresis (to collect specific blood~          cells).~        -  Adult relatives will provide additional samples through more invasive procedures such~          as leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of~          age) will not undergo these invasive procedures.~        -  No treatment will be provided as part of this protocol.~   "
141641|NCT01200810|"~     This partially randomized phase II trial is studying how well giving bicalutamide together~     with RO4929097 works in treating patients with previously treated prostate cancer. Androgens~     can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide,~     may lessen the amount of androgens made by the body. RO4929097 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving bicalutamide together~     with RO4929097 may be an effective treatment for prostate cancer~   "
141642|NCT01200797|"~     This phase II trial is studying how well SJG-126 works in treating patients with epithelial~     ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous~     treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
141643|NCT01200784|"~     Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum~     phosphate levels of dialysis patients in a dose dependent manner.~   "
141875|NCT01197690|"~     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide~     (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma~     control according to the global initiative for asthma guideline.~   "
141644|NCT01200771|"~     Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many~     affections. The diagnostic process is still a challenge and could not be specified yet after~     several clinical studies performed by trained teams using two levels diagnostic procedures.~     For this reason, the diagnosis involves many additional and expensive tests such as computed~     tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based~     recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron~     emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT)~     is widely used in malignant diseases and seems to be promising for the diagnosis of~     inflammatory disorders. Its role has not been yet clearly defined in the investigation of~     FUO and chronic inflammatory syndrome.~   "
141645|NCT01200758|"~     This two-stage, multi-center, randomized, controlled, open-label study will investigate the~     pharmacokinetics, efficacy and safety of MabThera (rituximab) subcutaneous versus MabThera~     (rituximab) intravenous in patients with previously untreated follicular non-Hodgkin's~     lymphoma. Patients will be randomized to receive 375 mg/m² MabThera as intravenous infusion~     or 1400 mg MabThera given subcutaneously. In addition, patients will receive standard~     chemotherapy. Patients who achieved a complete or partial response after 8 treatment cycles,~     will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance~     treatment cycles will be repeated every 8 weeks. The anticipated time on study treatment is~     96 weeks.~   "
141646|NCT01200745|"~     The purpose of this study is to determine whether topical capsaicin patch can effectively~     reduce chronic neck pain.~   "
141647|NCT01200732|"~     A preliminary observational study by the investigators has shown that tadalafil, a selective~     phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in~     patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp),~     systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this~     placebo controlled trial was to assess the effect of the drug on exercise capacity and~     functional class compared to placebo.~   "
141648|NCT01200719|"~     To investigate the efficacy of using transcranial alternating current stimulation (tACS) to~     enhance the regaining of neurological function among post-stroke patients.~   "
141649|NCT01200706|"~     The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or~     three times a day to children with non-severe community-acquired pneumonia.~   "
141650|NCT01200693|"~     BACKGROUND:~      Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI).~     The selection of the type of drug-eluting stents (DES) and the technique for stent~     implantation have not been clarified. The side-branch (SB) is emerging as critical point,~     accounting for more than a third of the significant restenosis in the DES era. A series of~     data supports the adoption of a conservative strategy: stenting the main vessel (MV) only~     and reserving a conservative approach on the SB. Yet, the clinical relevance in terms of~     inducible ischemia of sub-optimal angiographic result has not been clarified.~      AIMS OF THE STUDY:~      The aims of the present study are:~        1. to compare in a prospective study the acute 3D angiographic results and the late~          clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting (EES) vs Zotarolimus~          eluting stent (ZES) obtained using a provisional TAP-stenting technique.~        2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal~          angiographic result in the SB after stenting.~      METHODS TO BE APPLIED:~      75 consecutive patients with bifurcated lesions undergoing PCI with the provisional~     T-and-small-protruding (TAP) technique with ZES implantation will be enrolled. Procedural~     and post-PCI details will be prospectively recorded. The subgroup of patients in which~     complete revascularization has been achieved will enter a systematic assessment of inducible~     ischemia by early and late exercise tests.~      Off line 3D quantitative coronary angiography (QCA) assessment will be performed and used to~     divide the study population in 2 groups according to the SB residual stenosis:~        -  Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%~        -  Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.~      For the comparison among SES and EES, data will be obtained from the randomized trial~     SEA-SIDE (NCT00697372).~      PRIMARY STUDY END-POINTS.~        1. COMPARISON BETWEEN ZES, SES AND EES:~           SB acute angiographic result; SB trouble; target bifurcation failure.~        2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:~          inducible ischemia at the early exercise test or occurrence of early spontaneous~          ischemia related to the SB.~   "
141651|NCT01200680|"~     Background:~      Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the~     embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum~     and coccyx), is more frequent in males than females, and has a median age at diagnosis of~     58.5 years, with a wide age range. This typically sporadic tumor is often advanced at~     presentation, and mortality is high due to local recurrence or distant metastases. The usual~     treatment is surgery, followed by adjuvant radiation therapy. Chemotherapy has not had a~     significant treatment role. Reports of a small number of families worldwide with two or more~     relatives with chordoma support a role for susceptibility genes in chordoma etiology.~     Recently we determined that duplications of the T gene co-segregated with disease in four~     multiplex chordoma families. The T gene encodes brachyury, a tissue-specific transcription~     factor that is expressed in notochord cells and is essential for formation and maintenance~     of the notochord. Some of the other chordoma families that we studied did not have T-gene~     duplications; the aggregation of chordomas in these families may result from changes in~     other susceptibility genes or other types of mutations targeting the T gene. We are~     continuing gene identification studies of multiplex chordoma families at the NIH Clinical~     Center under protocol 78-C-0039. We also want to determine whether alterations in any~     identified chordoma susceptibility genes are associated with sporadic chordoma in the~     general population.~      Objectives:~      The major goal of this protocol is to identify sporadic chordoma patients willing to provide~     germline and tumor DNA for studies to determine the frequency of alterations in chordoma~     susceptibility genes. Our previous protocols with SEER and Massachusetts General Hospital to~     identify chordoma patients were limited to residents of specific geographic regions in the~     U.S. (2 states and 2 metropolitan areas) or to patients with pediatric skull base tumors.~     This protocol will enroll patients who more broadly represent the age, site and gender~     distributions of sporadic chordoma in the general U.S. population.~      Eligibility:~      Eligible patients are males and females in the U.S. with chordoma diagnosed at any age and~     at any primary site. Because we want to obtain saliva from all participants, eligibility is~     limited to patients who will be greater than or equal to age 6 years at the time of~     enrollment.~      Design:~      The study description and contacting information including an e-mail link to the study~     contact person will be posted on web sites of two chordoma support groups. We will mail~     study information to be given to patients to colleagues at major medical centers that treat~     chordoma.~      The components of the study will be carried out in subjects' homes using materials mailed to~     them. Up to 100 participants will: 1) complete a self-administered Personal and Family~     Medical History Questionnaire, 2) collect saliva using a saliva collection kit, and 3)~     provide permission to obtain medical/pathology records, and paraffin blocks or slides on~     each primary chordoma. Parents will serve as proxies for minor children.~      We will recontact patients who report chordoma in at least one blood relative. If we confirm~     the relative's chordoma diagnosis, we will invite the study subject and selected family~     members to participate in clinical and gene mapping studies under protocol 78-C-0039. We may~     also recontact study participants to tell them about any new studies on chordoma etiology.~     They can decide at that time whether they want to participate in them.~   "
141652|NCT01200667|"~     The application scenario is shown in the figure below: the user utilizes an ECG-based~     wireless sensor (WiBoC Chipset), and transmit those signals to a mobile-phone device that~     has an embedded expert system integrated. With the aid of 3G system, a remote healthcare~     monitoring center receives those uploaded signals and stores into the application server.~     According to the events from this server, the people on service responses to the emergency~     and takes the corresponding process.~   "
141653|NCT01200654|"~     Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a~     specific inhibitory activity against Gram positive bacteria, including methicillin-resistant~     Staphylococcus aureus (MRSA).~      Dosage of 600 mg discontinuous administration twice a day was about studies in safety~     volunteers. The intensive care units patients, with mechanical ventilation, and with severe~     sepsis, represent highly heterogeneous population responsible of hight variability in~     pharmacokinetics parameters (augmentation in total volume of distribution, modification in~     glomerular filtration) wich can lead to antibiotic inefficacy.~      In a first time, this study describe the pharmacokinetics of Linezolid in intensive care~     units patients with severe MRSA infection. The aim of this study is to define and validate a~     population pharmacokinetic model including the influence of patients' characteristic on the~     pharmacokinetics of Linezolid.~   "
141662|NCT01200537|"~     The purpose of this randomized controlled trial is to compare the efficacy and effect of~     luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and~     synchrony in a poor responder population. The randomized groups consist of: 1. patients~     receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for~     1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be~     followed and compared in each group. Coefficient of variation will be used to evaluate~     follicle size discrepancy. Chi square analysis will be used to compare categorical variables~     between treatment groups. Both estradiol and COPCs are used clinically in assisted~     reproduction, so this study affords no additional risks to the participants.~   "
141663|NCT01200524|"~     A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days~     treatment in patients with posttraumatic neuralgia.~   "
141664|NCT01200498|"~     The goal of this clinical research study is to learn if SB939 can help to control~     myelofibrosis. The safety of this drug will also be studied.~   "
141665|NCT01200485|"~     The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2~     cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of~     allopurinol. The safety of this treatment will also be studied.~   "
141654|NCT01200641|"~     Principle goals of sedation for eye surgery are to provide patient comfort and to allow the~     patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation~     may not prevent the patient from moving during retrobulbar injection, whereas very deep~     sedation may result in respiratory complications during surgery .The investigators compared~     the effect of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and~     pain and satisfaction profile in cataract surgery. After approval by the Hospital Evaluation~     Committee of Scientific Studies for ethical purpose and written informed consent, ninety~     patients scheduled for cataract surgery by phacoemulsification were randomly allocated to~     three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n~     = 30)or placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic~     parameters ,anxiety, sedation score , and pain during block and surgery, satisfaction of~     surgeon were assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no~     pain and 10 = worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0=~     completely calm, 10 = the worst possible anxiety) were explained to patients. Then a 20~     gauge cannula was inserted into one of the two hands. Patients were monitored with~     electrocardiogram, noninvasive measurement of blood pressure, and pulse oximetry (SPO2).~     Retrobulbar nerve block was performed by the same ophthalmic surgeon who was unaware of~     group allocation with 1.5 ml of solution that prepared by nurse( lidocaine 2%and 0.5 ml~     bupivacaine) via the percutaneous route with a 25 G, 38 mm Atkinson needle (John Weiss & Son~     Limited, Milton Keynes,England), at inferotemporal site. No patient received an additional~     facial nerve block. The investigators assessed the pain immediately after block and surgery.~     Anxiety score and pain score was recorded in each patient before premedication (T1), ninety~     minutes after premedication, on arrival in the operating room (T2), one minute after~     retrobulbar block placement (T3)during the operation period) (T4) and postoperatively before~     discharging the patient from the recovery room (T5) .At the end of surgery, the patients~     were asked about average level of their anxiety and pain during the operation period~     according to the VAS and VPS explained to them before premedication.`. The surgeon was also~     asked to verbally rate their level of satisfaction according to three degree scale as very~     bad, , moderate, good after the operation. The sedation level of patients during performance~     of block was assessed as Sedation scores were obtained on a 3 point scale with 0 =movements~     of the head, arms and trunk ,1 =slightly movement of arms,2=slightly change in~     face,3=complete calm. If sedation was inadequate, fentanyl could be given 0.5microgram/kg as~     needed.~   "
141655|NCT01200628|"~     Posttraumatic stress disorder (PTSD) is a serious and often chronic response to~     overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with~     increased rates of medical morbidity, poor health-related quality of life, and functional~     impairment. PTSD is prevalent in primary care settings after road traffic accident, where~     approximately 25% of patients meet diagnostic criteria for the disorder. Despite the~     development of a number of efficacious behavioral and pharmacological treatments, only a~     minority of patients with PTSD receive mental health services. PTSD is frequently~     underrecognized and untreated in Emergency Department and Surgical Unit.~      Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high~     risk and lead them to benefit of personalized cares. Nevertheless it is not possible~     (neither useful) to provide psychological cares for each road traffic accident victim.~      This is the reason why we think that nurses can help to screen patients who need treatment~     for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during~     road traffic accident victim hospitalization in surgical unit could allow beginning specific~     treatment using consultation liaison psychiatry.~      Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing~     surgical functional efficacy and improve convalescence programs. The use of a specific~     questionnaire could help to screen this disorder.~      We have created the DEPITAC scale : a short screening questionnaire with 10 items.~      This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder~     (PTSD) for use in surgical or emergency department.~   "
141656|NCT01200615|"~     In this study we invetigate the influence of the nocebo effect (as part of obtaining~     informed consent) on the prevalence of side-effects. The study is prospective, focusing on~     the connection between what the physicians says to the patient about side-effects to the~     frequency of these side effects during treatment period. We also inquire whether informing~     the patient about the existence of the nocebo effect influences the extent of phenomena.~   "
141657|NCT01200602|"~     RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by~     cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or~     anorexia in young patients with malignancies who are undergoing radiation therapy and/or~     chemotherapy.~   "
141658|NCT01200589|"~     This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1)~     phase III study of single agent ofatumumab compared to single agent rituximab in subjects~     with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6~     months after completing treatment with single agent rituximab or a rituximab-containing~     regimen. Subjects must have attained a Complete Response or Partial Response to their last~     prior rituximab containing therapy lasting at least six months beyond the end of rituximab~     therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or~     rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2~     months for four additional doses. Therefore, subjects will receive a total of eight doses of~     anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion~     of the first four doses of therapy, after six doses of therapy, and after completion of~     study therapy. Subjects will be followed until the end of the designated follow-up period~     (total study duration of 200 weeks) or until they meet the withdrawal criteria.~   "
141659|NCT01200576|"~     This one-year observational study will monitor the contraceptive effectiveness, safety and~     acceptability of Zarin during the first year of use after the method has been approved for~     public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical~     support from Marie Stopes International and FHI. 300 women of reproductive age who selected~     Zarin as their primary method of contraception will be enrolled in the study at the MSM~     outreach sites and static clinics.~   "
141660|NCT01200563|"~     The purpose of this study is to evaluate the clinical and economic effectiveness of MIST~     Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness~     wounds presenting in the LTACH and SNF settings.~   "
141661|NCT01200550|"~     The purpose of this study is to evaluate symptoms control and impact on daily life from~     patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another~     objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD~     treatment in primary care.~   "
141679|NCT01200303|"~     The purpose of this study is to evaluate the performance of a non-cathartic,~     computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of~     pre-cancerous colon polyps in a group of asymptomatic screening patients.~   "
141680|NCT01200290|"~     The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are~     a barrier to kidney transplant. Transplantation is currently the definitive treatment for~     End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.~   "
141666|NCT01200472|"~     STUDY DESIGN:~      This is a phase 2, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, efficacy and safety study in 30 patients with erosive osteoarthritis of~     interphalangeal joints. The study is composed of 4 phases: a pre-randomization phase for up~     to 35 days followed by a 91-day randomized, double-blind two arm treatment phase, followed~     by a 77-day open label treatment phase for all study participants and a 28-day observational~     follow-up phase. Efficacy of the double blind and open label phase will be assessed at study~     day 84 and 168 after treatment start respectively.~      STUDY DURATION:~      The study length will be approximately 231 days for individual patients. With approximately~     a 12 month recruitment period the study is planned to last from January 2010 until July 2011~     (19 months).~      STUDY OBJECTIVES:~      The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day~     [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the~     symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on~     pain, disease activity, structural damage, quality of life, safety and tolerability.~   "
141667|NCT01200459|"~     The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control~     trial designed to evaluate the hypothesis that weight status at 24 months will be~     significantly better for the SMART intervention recipients than for those who receive the~     comparison condition.~   "
141668|NCT01200446|"~     Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy~     cardiovascular system, maintain brain function, reduce depression, and improve inflammatory~     diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced~     bronchoconstriction and airway inflammation as compared to placebo.~   "
141669|NCT01200433|"~     The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral~     blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically,~     the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol~     for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as~     measured by near-infrared spectroscopy.~   "
141670|NCT01200420|"~     The main purpose of this study is to determine the safety and tolerability of multiple~     dosing of miravirsen in subjects infected with chronic hepatitis C.~      Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of~     miravirsen's effect on HCV viral titer.~   "
141671|NCT01200407|"~     The purpose of this study is to determine the safety, tolerability and efficacy of~     Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.~   "
141672|NCT01200394|"~     PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791~     will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,~     improving renal function.~   "
141673|NCT01200381|"~     It's the aim of this study to analyze the benefit of personal patient / physician contacts~     in heart failure patients with remotely monitored implanted cardioverter defibrillators~     (ICD) or ICD with cardiac resynchronization therapy (CRT-D).~      The personal follow up (in clinic or phone calls) will be compared to completely automatic~     remote follow ups.~      All patients will receive remote monitoring for automatic daily alarm checks and will~     undergo in clinic follow ups in 12 months intervals~   "
141674|NCT01200368|"~     Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group~     1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular~     pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,~     Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar~     (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be~     open-label. The main purpose of the study is to determine if the immune responses to 13vPnC~     are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given~     with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims~     to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when~     given with DTaP in healthy Japanese infants.~   "
141675|NCT01200355|"~     The purpose of this study is to compare the effects, good and/or bad, of posaconazole and~     micafungin in preventing fungal infections after chemotherapy for acute leukemia or~     myelodysplastic syndrome. When people take chemotherapy, they are more likely to get~     infections. Posaconazole has been approved for the prevention of fungal infections in~     patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.~     Posaconazole is available only as an oral suspension and has to be given with food. After~     chemotherapy, many patients are not able to tolerate food or oral medication because of~     severe mucositis. Patients unable to tolerate food and oral medications cannot take~     posaconazole.~      Micafungin is an antifungal medication that is given only intravenously. Micafungin is~     approved for the treatment of certain fungal infections and for preventing fungal infections~     in patients who receive bone marrow transplant. The investigators know that micafungin is~     safe. Micafungin has not been tested for the prevention of fungal infections in patients~     receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin~     is given by vein, it can be given even in patients who cannot take food or medications by~     mouth after chemotherapy. In this study the investigators want to compare micafungin to~     posaconazole when given for the prevention of fungal infections in leukemia and~     myelodysplastic syndrome patients.~   "
141676|NCT01200342|"~     The goal of this clinical research is to learn if the combination of Genasense (oblimersen),~     carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety~     of this combination will also be studied.~   "
141677|NCT01200329|"~     The goal of this clinical research study is to learn if the combination of gemcitabine,~     busulfan, and melphalan, when given before a stem cell transplant, can help to control~     refractory Hodgkin's disease. The safety of this study treatment will also be studied.~   "
141678|NCT01200316|"~     After having abdominal surgery, patients often experience a lack of bowel function that can~     cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as~     post-operative ileus. Patients are usually not allowed to leave the hospital until their~     doctor is sure that their bowel function has returned.~      The goal of this clinical research study is to compare using a rocking chair to the standard~     of care in improving post-operative ileus after abdominal surgery.~   "
141977|NCT01196364|"~     The investigators hypothesize exercise increases short term appetite and food intake, and~     interferes with satiety and satiations to a preload in normal weight, boys.~   "
141681|NCT01200277|"~     The standard care in patients with a painful osteoporotic vertebral compression fracture~     (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive~     technique for pain treatment in which bone cement is injected in the fractured vertebra.~     Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV~     while an unmasked but controlled RCT found significantly better pain relief after PV at~     acceptable costs.~   "
141682|NCT01200264|"~     This is a Phase II, open label, investigator-initiated study to be done at Duke University~     Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have~     failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment,~     the patient must have received biologic therapy without achieving a response of almost~     clear or clear according to PGA or has not responded with a 75% reduction of PASI score.~     Once deemed eligible, subjects will return for a baseline visit and receive Apremilast~     therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects~     will be evaluated 28 days after last dose of Apremilast for safety and efficacy.~   "
141683|NCT01200251|"~     A internally controlled, single-blinded, randomized controlled trial to investigate the use~     of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who~     suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and~     IRB approval have been obtained.~   "
141684|NCT01200238|"~     STA-9090 is drug which inactivates or blocks the work of a protein called Heat Shock Protein~     90 or HSP90. HSP90 is a protein that helps some molecules inside the cells have the right~     shape. By stopping it's activity, these molecules never get to have the right structure to~     be functional and they are destroyed. We believe that if we stop the activity of HSP90, the~     rapidly dividing cells in the tumor(s) will slow down since their proteins will not be~     functional without the help of HSP90.~   "
141685|NCT01200225|"~     This prospective observational study will assess the insulin resistance and its impact on~     sustained virological response in patients with hepatitis C treated with Pegasys and~     Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and~     for 24 weeks of treatment-free follow-up.~   "
141686|NCT01200212|"~     The purpose of this study is to determine whether~        -  Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent~          results of the AVADO study report a similar result for the combination of docetaxel and~          bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of~          bevacizumab.~        -  As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens~          with bevacizumab and at least 2 cytotoxic agents should be investigated.~        -  Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is~          therefore a reasonable choice.~        -  Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to~          improve tolerability without compromising efficacy.~        -  Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months.~        -  Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2~          much more accepted in daily practice. Better comparability with DBX, if both arms have~          75mg/m2 docetaxel as assumed.~   "
141687|NCT01200199|"~     The purpose of this study is to contribute to the validation of an electronic daily diary to~     assess symptoms in patients with varicose veins.~   "
141688|NCT01200186|"~     Prospective, non-interventional, multi-center study. Each subject will be followed for up to~     twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin~     Only Pill). For each subject demographic data and medical history will be documented at~     Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment~     (satisfaction and wellbeing) and adverse events including unintended pregnancies will be~     documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be~     done.~   "
141689|NCT01200173|"~     This multicentric, randomized, double-blind and controlled study aims to examine the effect~     of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001~     (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common~     infectious diseases (cumulated number of infections during the intervention period: primary~     criteria) in children aged 3-6 years, attending day care centers.Volunteers received either~     200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a~     1-month follow-up.~   "
141690|NCT01200160|"~     Post-Marketing Observational study of Niaspan® tablet in accordance with each country~     regulations. This study will be conducted in a prospective, single-arm, multi-center format.~     As this study is observational in nature, the follow-up of subject's is not prescriptive in~     nature and is according to the judgment of the physician (investigator in the course of~     treatment for each patient), within the period of observation of 12 months. This includes an~     enrollment period of 6 months in which each subject will be observed for approximately 6~     months. Examinations, diagnostic measures, findings and observations performed as per usual~     medical practice during the observation period will be recorded on Case Report Forms (CRFs)~     by the investigator or site staffs according to the protocol.~   "
141691|NCT01200147|"~     Dysphagia is a common reason for referal to the investigators Gastoenterology service. As~     many as 14% of patients undergoing radiological studies for dysphagia are found to have~     schatzki rings. Current recommendations for treatment of patients with symptomatic Schatzki~     rings are based on ancedotal experience and uncontrolled studies. The only randomized study~     on comparison of techniques the investigators were able to locate was published in 2000 and~     included only 26 patients. This study demonstrated that the biopsy techinque was as~     effective as and better tolerated than the standard dilation technique. Considering that the~     cost and time required for dilatation is greater than the basic biopsy technique,~     significant cost savings could be achieved using the biopsy technique. As well, patient~     satisfaction is an important factor considering that Schatzki rings can recur and repeated~     endoscopy is often required. Therefore, a study that shows a technique to be as or better~     than the current standard in effectiveness, cost, time, and patient comfort could lead to~     shift in current practice.~   "
141692|NCT01200134|"~     Background :~      In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression.~     This multidisciplinary preclinical and clinical project aims to validate the use of~     18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas.~     Indeed, non-invasive methods of imagery such as Positron Emission Tomography (PET) and~     biological methods (after surgical resection) to detect the endogenous expression of factors~     induced by the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy,~     the hypoxic areas could allow the clinicians to evaluate the response to the anti-angiogenic~     agents (preliminary validation in the preclinical project) and to optimize the combination~     of the anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy,~     chemotherapy or other molecules).~      Research project :~      This research project includes 3 steps : first the investigators will establish the~     18F-FMISO production technique for clinical application at CYCERON PET center. The second~     step consists in the preclinical validation of 18F-FMISO as a hypoxic marker and as a~     powerful tool for evaluating the therapeutical efficiency of anti-angiogenic treatment~     (sutent) in experimental rat gliomas. The third step is the clinical trial HypOnco. This~     research proposal aims to develop and use non invasive imaging methods (18F-FMISO with PET)~     and biological methods (after surgical resection) to detect hypoxic (HIF1 and HIF2) and~     angiogenic (VEGF and EPO) regions in different malignant gliomas with different degrees of~     vascularization (15 patients with grade III gliomas and 15 patients with grade IV~     glioblastomas). Within the same patient 18F-FMISO as a hypoxic index will be performed. A~     magnetic resonance imaging examination (MRI) including perfusion sequences and MR~     spectroscopy will also be assessed for each patient. Following this imaging protocol,~     surgical resection will be performed allowing us to study expression of endogenous factors~     induced by hypoxia and angiogenic factors by real time RT-PCR and in immunohistochemistry.~      The data obtained will enable us to establish :~        -  a hypoxic index (18F-FMISO with PET).~        -  an index of hypoxic factor expression (HIFs)~        -  an angiogenic index (VEGF, EPO, vascular markers)~      The investigators will characterize the links between these data and also with the following~     parameters:~        -  clinical (age, Karnofsky performance status, survival)~        -  MR parameters included perfusion and spectroscopy~        -  histological (necrosis, cellular proliferation, atypical cell abnormalities,~          vascularization).~      Expected results and clinical advantages~        -  To establish the 18F-FMISO production technique~        -  To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic~          treatment in a preclinical study.~        -  To define the relationship between the 18F-FMISO uptake and tumour grade, patient~          survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour~          vascularisation.~        -  To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis~          and prognosis improvement for optimal treatment orientation and strategy.~      In the field of the clinical applications, this tool will allow to :~        -  Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the~          most hypoxic areas which are also the most radio resistant.~        -  Evaluate antiangiogenic therapy efficacy~   "
141709|NCT01199913|"~     The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with~     endotracheal intubation will result in decreased POCD compared to sevoflurane if the~     patient's MAP is within 20% of the patient's baseline and the cerebral suppression state~     index stays within the moderately anesthetized range during general anesthesia.~   "
141693|NCT01200121|"~     Malignant ascites represents a severe clinical problem for physicians and patients being~     confronted with this common symptom of advanced-stage gastrointestinal cancer.~     Unfortunately, there is no standardized and evidence-based treatment for malignant ascites~     and therapies which are commonly being used are only temporarily effective. Newer modes of~     therapy, such as the application of the tri-functional antibody catumaxomab, are associated~     with significant side effects and are limited to patients in stages of good overall~     performance. Therefore, there is still an urgent need for more effective, longer-lasting,~     and less toxic modes of treatment for peritoneal effusions caused by gastrointestinal~     cancers.~      Preclinical data strongly suggest that bevacizumab might be a very effective agent for the~     treatment of malignant ascites, which is in large part caused by the~     hyperpermeability-promoting factor VEGF. Emerging clinical results from cancer patients with~     malignant ascites treated with bevacizumab add further support to this idea. Bevacizumab has~     been tested in a variety of large clinical trials, has a good toxicity profile, and is~     effective in a number of human cancers underlying malignant ascites.~      In the present study, Bevacizumab will be administered as an intraperitoneal infusion at an~     absolute standardized dosage of 400 mg. This dosage was chosen because it is comparable to~     the approved standard dosage for intravenous administration which was also used in both~     studies reporting the successful and safe intraperitoneal administration of Bevacizumab to~     patients with malignant ascites. Finally, a standardized dosage seems more practical in the~     particular patient population treated in this study.~   "
141694|NCT01200108|"~     The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of~     the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of~     oral corticosteroid dose and stability/improvement of clinical parameters related to asthma~     in the targeted subject population. Ultimately, the goal is to free subjects with severe~     asthma from the burden of chronic oral steroid therapy.~   "
141695|NCT01200095|"~     This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit~     technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated~     the results of patients with PCL ruptures, who undergoing PCL reconstruction using this~     unique technique.~   "
141696|NCT01200082|"~     The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary~     elimination can be used as a biomarker to predict the severity and prognosis of~     hepatobiliary diseases. The investigators rationale in this project is that the discovery of~     biomarkers specific to liver injury would provide the foundation for a specific and~     non-invasive tool to evaluate disease prognosis, determine patients with higher risk of~     developing end-stage liver diseases, and determine patients with higher risk of recurrence~     of hepatobiliary complications after liver transplant. The investigators propose the~     following specific aims to test the investigators hypothesis:~      Specific Aim #1: Establish a baseline of individual and total urinary BAs and BA-sulfates in~     healthy controls and patients with hepatobiliary diseases. A baseline reference of the~     average and distribution of the percentage of urinary BA-sulfates will be determined in~     healthy subjects and in patients with hepatobiliary diseases including chronic hepatitis~     C/B, alcoholic liver disease, hereditary, drug-induced, and autoimmune hepatobiliary~     diseases. The investigators working hypothesis is that patients' capability to sulfate total~     or specific BAs, as determined by the percentage of total or specific BAs excreted in the~     sulfate form, can predict the severity of hepatobiliary diseases, as determined by mayo~     model for end-stage liver disease (MELD) score and compensation status(compensated and~     decompensated). Patients with higher MELD score are considered to be at higher risk of~     developing severe hepatobiliary complications.~      Specific Aim #2: Determine the relationship between BA sulfation and the progression of~     hepatobiliary diseases. This is an exploratory aim to collect preliminary data on the~     relationship between urinary BAs and the progression of hepatobiliary diseases in~     liver-transplant and non-liver-transplant patients, as monitored over a1-year period. The~     investigators working hypothesis is that patients' capabilities of sulfating BAs determine~     the progression of the disease.~      Patients on the liver transplant list are continuously monitored during their~     hospitalization and are scheduled for follow-up visits for 12 months after their release~     post-surgery. Disease progression will be evaluated by monitoring MELD scores, survival,~     incidence of liver transplant, and incidence of complications related to hepatobiliary~     conditions such as fluid retention, GI bleeding, encephalopathy, and biliary stricture~     complications.~   "
141697|NCT01200069|"~     Post-procedure myalgia (muscle ache) is a well-known and common complication of~     Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in~     approximately 50% of these cases. The pain is usually described as muscle soreness, similar~     to that resulting from strenuous exercise. The myalgias typically begin shortly after the~     procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of~     patients considered prevention significant and would be willing to pay a median of $33 out~     of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a~     further financial burden if these patients are unable to return to work or resume previous~     daily activities in the days following the procedure. An agent that could treat and possibly~     even prevent these myalgias has the potential to be very beneficial to these patients. IV~     ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and~     Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an~     adjunct to opioid analgesics, and for the reduction of fever.~   "
141698|NCT01200056|"~     While statin treatment may induce plaque regression, the effect of statin on plaque~     composition with varying doses is unknown. This study assessed such effects by volumetric~     virtual histology intravascular ultrasound (VH-IVUS).~      In this prospective, randomized, double-blinded pilot study, statin-naïve patients with~     stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive~     6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI~     lesions at baseline and 6 months; all analyses were performed by core laboratory.~   "
141699|NCT01200043|"~     The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the~     metabolic diseases that go along with obesity, termed metabolic syndrome. Obese children~     with metabolic disease will be studied before and after 10 days of a fructose restricted~     diet. The question is whether their co-morbidities will improve, even if weight remains~     constant.~   "
141700|NCT01200030|"~     The investigators hypothesize that application of electrical stimulation would augment the~     effects of exercises in patients with stroke. Combined electrical stimulation with exercises~     for 6 weeks would lead to earlier and greater improvement in motor functions when compared~     with placebo-stimulation with exercises.~   "
141710|NCT01199900|"~     This study will investigate the effect of a single dose of PF-04171327 or prednisone on~     calculated measures of glucose tolerance and insulin resistance by using a modified oral~     glucose tolerance test~   "
141711|NCT01199887|"~     This is an open label, Phase One, multicenter study, designed to evaluate the safety,~     tolerability, to explore the biologic effects, and to explore the clinical effects of the~     following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a~     day orally for 24 weeks in patients with IPF.~   "
141978|NCT01196351|"~     The investigators hypothesize exercise increases short term appetite and food intake, and~     interferes with satiety and satiations to a preload in normal weight, overweight and obese~     boys.~   "
141701|NCT01200017|"~     This protocol provides expanded access to bone marrow transplants for children who lack a~     histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor~     (unrelated donor or half-matched related donor) is available to donate. In this procedure,~     some of the blood forming cells (the stem cells) are collected from the blood of a partially~     human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the~     patient (the recipient) after administration of a conditioning regimen. A conditioning~     regimen consists of chemotherapy and sometimes radiation to the entire body (total body~     irradiation, or TBI), which is meant to destroy the cancer cells and suppress the~     recipient's immune system to allow the transplanted cells to take (grow). A major problem~     after a transplant from an alternative donor is increased risk of Graft-versus-Host Disease~     (GVHD), which occurs when donor T cells (white blood cells that are involved with the body's~     immune response) attack other tissues or organs like the skin, liver and intestines of the~     transplant recipient. In this study, stem cells that are obtained from a partially-matched~     donor will be highly purified using the investigational CliniMACS® stem cell selection~     device in an effort to achieve specific T cell target values. The primary aim of the study~     is to help improve overall survival with haploidentical stem cell transplant in a high risk~     patient population by limiting the complication of GVHD.~   "
141702|NCT01200004|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Grifola frondosa extract, azacitidine, and lenalidomide that can be given to~     patients with advanced cancer. The safety of this drug combination will also be studied.~   "
141703|NCT01199991|"~     Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for~     determining bone density. However, most experts consider DXA an imperfect and intermediate~     technology. DXA is subject to artifact from arthritis and body composition, and also cannot~     account for geometric or material properties of bone which are also important components of~     bone strength.~      Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new~     technology with dramatically improved spatial resolution. It is able to define bones'~     cortical and trabecular surfaces in a three-dimensional manner, and therefore provides~     information on bone microarchitecture as well as bone density. As such, it may provide new~     information about characteristics of bone strength.~      The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and~     also to generate a normative database of healthy young adults. This cross-sectional study~     involves a single visit where both Xtreme CT and DXA measurements will be obtained for a~     single time-point. This normative database will allow us to generate clinically relevant~     comparisons between the two imaging technologies.~   "
141704|NCT01199978|"~     In this research study we are looking at another type of radiation called proton radiation~     which is known to spare surrounding normal tissues from radiation. The proton radiation will~     be delivered using fractionated stereotactic radiotherapy (FSRT) to improve localization of~     the small tumor target. Proton radiation delivers minimal radiation beyond the area of the~     tumor. This may reduce side effects that patients would normally experience with~     conventional radiation therapy. In this research study, we are looking to determine the~     effects of fractionated proton radiotherapy on long-term hearing preservation and~     controlling tumor growth.~   "
141705|NCT01199965|"~     Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral~     inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.~      Identify whether there are clinically significant differences in the tolerability of MAP0004~     between smokers and non-smokers.~   "
141706|NCT01199952|"~     Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the~     treatment group than in the control group.~      Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion~     in women who choose combined hormonal contraception (CHC) and who receive a three-week~     educational phone call as compared to women who do not receive the intervention.~      Secondary Aims~        -  To describe the most common concerns and logistical problems women experience with~          initiating and adhering to CHC after abortion.~        -  To describe the concerns that lead to discontinuation or method change. *To assess~          feasibility of conducting a follow-up telephone call in this population This is a~          randomized, controlled trial to assess the effect of a three-week follow-up phone call~          in women who choose combined hormonal contraception on the day of their abortion at the~          San Francisco General Hospital Women's Options Center. Subjects randomized to the~          treatment group will receive an interventional phone call three weeks after their~          abortion; participants randomized to the control group will not receive the call. All~          subjects will receive a follow-up call six weeks after their abortion to assess and~          compare method use between the two groups. Calls will be made at three- and six-weeks~          post abortion in order to give subjects enough time to initiate CHC and to assess~          continuation into the second month of the method. Data will be collected at baseline,~          during the intervention for the treatment group and during the final follow-up call for~          both groups. The primary outcome is use of an effective contraceptive six weeks after~          abortion.~   "
141707|NCT01199939|"~     This study is a Phase II single arm, open-label, multicenter, study of 50 human~     immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine~     (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to~     evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of~     patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected~     patients. In addition to general safety parameter measurements, this trial will also assess~     changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will~     occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the~     treatment period is 48 weeks. The end of study endpoint will be met by either completing the~     Week 48 visit, or by early termination from the study for any reason.~   "
141708|NCT01199926|"~     The study was designed to assess the effects of vitamin D supplementation during exercise~     training on body composition, muscle function, and glucose tolerance. The investigators~     hypothesis for these studies is that vitamin D supplementation enhances exercise-induced~     increases in strength and lean mass, potentially through enhancing insulin sensitivity and~     reducing inflammation.~   "
141763|NCT01199198|"~     The goal of this clinical research study is to learn if tolvaptan can help raise salt~     (sodium) levels in the cancer patients' blood by removing extra body water as urine.~   "
141712|NCT01199874|"~     Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all~     diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and~     Rotateq® were licensed in many high and middle income countries in 2006, but lack of~     efficacy data in low income countries had prevented WHO from making a universal~     recommendation of their use until recently. This study will be conducted in Pakistan and~     will look at two objectives:~        1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks~          of life and at 6, 10 and 14 weeks of life.~        2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of~          vaccine administration with infants whose breast feeding is withheld for one hour~          before and after vaccine administration.~   "
141713|NCT01199861|"~     This study will evaluate the effect of treatment with fingolimod on the immune response~     following seasonal influenza vaccination and tetanus booster injection in patients with~     relapsing MS.~   "
141714|NCT01199848|"~     The purpose of this study is to test whether compounds found in strawberries (polyphenolics~     which are typically found in berry products, tea, coffee, red wine, and chocolate) will help~     reduce insulin resistance and inflammation, known factors in your blood associated with~     disease risk, when eaten with a standard high fat/carbohydrate meal.~   "
141715|NCT01199835|"~     The aim of the study is to investigate the long time effects of high and low intake of dairy~     products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation~     and appetite regulation in moderately overweight men and women over 24 weeks.~   "
141716|NCT01199822|"~     Participants in this single-center, open-label, dose-escalation, Phase 1 study will~     initially receive intravenous (I.V.) IMC-3G3 once every 2 weeks or on Days 1 and 8 every 3~     weeks for 6 weeks (one cycle). After the first cycle, patients experiencing an overall~     response of complete response (CR), partial response (PR), or stable disease (SD) will~     continue to receive IMC-3G3 at their cohort dose and schedule until there is evidence of~     progressive disease (PD), or until other withdrawal criteria are met.~   "
141717|NCT01199809|"~     This randomized, double-blind. placebo-controlled study will assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in~     patients with psoriatic arthritis who have or have had an inadequate response to oral~     disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs~     (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of~     RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.~   "
141718|NCT01199783|"~     Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in~     treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment~     with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of~     microbiologically confirmed gram-negative co-infection effective antibiotic treatment~     according to microbiologic analysis will be administered upon medical decision in both~     therapy groups. The study will be carried out as a randomized, open label study.~   "
141719|NCT01199770|"~     Investigators are interested in learning how appetite responds to pasta containing different~     amounts of protein and fiber when provided in two different portion sizes.~      In this research study, subjects will be asked to eat an entire pasta serving containing~     different amounts of protein and fiber mixtures. Subjects will be asked to do this on six~     separate occasions. One time subjects will not receive pasta, only water.~      After the pasta serving, there will be a buffet of deli style lunch items and subjects may~     eat as much they desire. Thereafter subjects will describe their feelings of hunger,~     fullness and desire to eat for 3 hours. In addition, blood will be taken throughout the~     study period to determine how eating pasta servings in different portion sizes impacts~     certain hormones released from the intestine, and therefore how they influence appetite. All~     study visits will take approximately 4 ½ - 5 hours.~   "
141720|NCT01199757|"~     Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from~     both ocular and nasal symptoms have a greater burden of illness and lower quality of life~     than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against~     both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in~     symptom control (both perceptually and objectively) and resource use for patients with~     current seasonal AR.~   "
141721|NCT01199744|"~     To collect background information of patients receiving a prescription for Relenza® and~     study risk factors etc. for adverse drug reactions collected through spontaneous reporting.~     In particular, to characterize the types and incidences of adverse events, serious adverse~     events, and adverse drug reactions and to investigate risk factors for them in patient~     populations that are regarded to be at high risk for novel influenza A (H1N1)and in which~     the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly~     persons, and those with decreased physical function) in accordance with the PFSB/SD~     Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW,~     dated 4th September 2009.~      To compare the data with the safety data collected in overseas sentinel site monitoring~     programs.~   "
141722|NCT01199731|"~     This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult~     subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and~     200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The~     background ART for all three arms will be darunavir/ritonavir (DRV/r) 600 mg/100 mg twice~     daily plus raltegravir (RAL) 400 mg twice daily. Antiviral activity, safety, PK, and~     development of viral resistance will be evaluated.~   "
141723|NCT01199718|"~     This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest~     safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple~     myeloma.~   "
141724|NCT01199705|"~     The objective of this study is to assess the efficacy, safety, tolerability, and~     pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary~     immunodeficiency (PID). In addition, the study will assess the health-related quality of~     life and pharmacoeconomic aspects related to treatment with IgPro20.~   "
141777|NCT01199016|"~     Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective~     against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.~     It is expected that the effectiveness of Prevnar 13 against ear infections in children will~     be similar to that observed following Prevnar. Pfizer has committed to conduct a~     postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.~   "
141725|NCT01199692|"~     Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have~     proven relatively ineffective for treating obesity, and once metabolic abnormalities such as~     Type 2 Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events~     remain elusive. More positively, the identification of a scientific resolution for obesity~     and T2D in the short-term is not outside the bounds of reality. Because the complexity of~     metabolic regulation is likely to include already characterized biomarkers, as well as other~     unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity,~     body mass distribution, dietary habits, exercise habits, medication requirements, and~     disease states to discover associations and pathways related to the restoration of normal~     metabolism.~   "
141726|NCT01199679|"~     The purpose of this study is to determine the safety and effectiveness of two separate~     procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two~     therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band~     Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using~     the Cook® Duette™ Multi-Band Mucosectomy device.~   "
141727|NCT01199666|"~     Although the investigators have reached the Healthy People 2010 goal of 80% coverage among~     U.S. children 19-35 months of age for the primary immunization series, 20% of children still~     remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of~     vaccine preventable disease persist. Immunization reminder-recalls have been shown to be~     successful, but have been limited by the ability to identify and reach large target~     populations in a real-time, automated fashion. Reminder-recalls via text message may offer~     an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a~     cell phone. Prior research by our team suggests that text messages reminder recalls may be~     an effective tool to remind parents about their children's vaccines. In this study, the~     investigators will demonstrate the effectiveness of tailored text message appointment and~     immunization reminders linked to a well-established and functional immunization registry to~     increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The~     investigators will target parents of young children from an underserved population that is~     primarily Latino, with low socioeconomic status.~   "
141728|NCT01199653|"~     The purpose of this study is to find whether to operate or treat conservatively dislocated~     midshaft clavicle fractures.~   "
141729|NCT01199640|"~     This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy~     in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose~     cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of~     new gadolinium-enhancing brain lesions during the screening and treatment periods.~   "
141730|NCT01199627|"~     The bleeding caused by hip replacement surgery (CRT) is an important source of demand for~     blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing~     bleeding associated with other surgeries and CRT results have been positive, but the variety~     of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in~     reducing bleeding caused by surgery of total hip replacement.~      PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform~     hip replacement surgery and cementless unilateral total that have signed the informed~     consent.~      Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional~     anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after~     the first administration.~      Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional~     anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at~     three hours after the first administration.~      Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the~     completion of regional anesthesia, and before the start of surgery.~      2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after~     the first administration.~      STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events~   "
141731|NCT01199614|"~     This is an open-label study of PTH(1-84) treatment that seeks:~        1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and~          urinary calcium excretion with use of standard amounts of calcium and vitamin D~          supplementation.~        2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis.~        3. To establish the safety of PTH(1-84) when administered for up to 12 years.~        4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism~          post PTH administration.~      There will be one visit conducted every six months in the study offices of the principal~     investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new~     patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the~     baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local~     Quest Lab performed to ensure stability prior to Baseline.~   "
141732|NCT01199601|"~     Baseline information indicates there are measurable levels of hepatitis B SAg and low~     utilization of postpartum contraception, correct breastfeeding practices, or adherence to~     infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize~     hospitals to assess the following aims:~      Aim 1: To determine whether the re-training and assignment of health care providers~     dedicated to intrapartum rapid testing and post-partum counseling will positively impact~     maternal and neonatal health indicators as compared to utilization of existing health~     providers for these services among women delivering in publish health maternity hospitals in~     Kabul, Afghanistan.~      Aim 2: To assess whether patients randomized to the intervention and their spouses perceive~     value in concentrated post-partum counseling.~      Aim 3: To investigate whether an intervention providing immediate post-partum provision of a~     long-acting family planning method would be feasible and acceptable to both men and women in~     Kabul, Afghanistan.~      Outcomes will be assessed through questionnaire responses and inspection of vaccination~     cards at six month intervals by trained study staff. The third aim will be addressed at the~     12 month follow-up visit.~   "
141733|NCT01199588|"~     This study is for subjects with a venous leg ulcer. The study is being done to determine if~     NEXAGON plus compression bandaging is more effective that placebo plus compression~     bandaging.~   "
145571|NCT01149239|"~     This study is to evaluate the level of anxiety, and to check the correlation of induction~     dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing~     thyroidectomy.~   "
141734|NCT01199575|"~     The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) is conducting a two-arm,~     multi-center phase II trial of Revlimid® and rituximab for Relapsed or Refractory CLL for~     patients under the age of 65 and patients 65 years and older.~      Lenalidomide (Revlimid) is an immunomodulatory agent with promising clinical activity in CLL~     and is FDA approved for treatment of relapsed multiple myeloma and 5q-myelodysplastic~     syndrome. Rituximab (Rituxan) is a monoclonal antibody to CD20 that is approved for the~     treatment of CLL.~      The primary objective of this study is to determine the overall response rate of the~     combination of Revlimid® and rituximab in previously treated CLL patients. All patients will~     receive treatment with Revlimid® starting at a low dose that will be dose escalated based on~     individual patient tolerability. The combination of Revlimid and Rituximab will be~     administered for a maximum of 7 cycles. Patients with residual leukemia following seven~     cycles of treatment with the combination may elect to continue on protocol for an additional~     6 cycles of single agent Revlimid® consolidation.~   "
141735|NCT01199562|"~     RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV)~     infection caused by a stem cell transplant.~      PURPOSE:This clinical trial studies infection prophylaxis and management in treating~     cytomegalovirus infection in patients with hematologic malignancies previously treated with~     donor stem cell transplant.~   "
141736|NCT01199549|"~     Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity~     and mortality in adults worldwide. While diet and increased physical activity constitute the~     primary preventive health approach, the role of plant-based bioactive compounds has~     attracted much attention due to their unique cardio-protective benefits. Several~     epidemiological studies suggest that dietary patterns characterized by relatively high~     intake of fruits and vegetables are significantly associated with reduced risks of coronary~     heart disease and stroke.~      Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby~     counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.~      However, this area is really lacking of a good set of chemistry, bioavailability and~     efficacy data that is vital for nutrition researchers and doctors to emphasize their role in~     the prevention and treatment of clinical outcomes at different stage of CVD, and~     dissemination of this information to the general public.~      Cambridge Theranostics has focused its efforts on developing products that can prevent the~     damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on~     understanding the cause of that damage.~      Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key~     ingredients in diets that long been known to reduce the risk of heart attack and stroke.~     However, they are normally poorly absorbed (not 'bioavailable'). The investigators unique~     production process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form~     that it can easily absorb and use.~      The aim of the current study is to perform and compare bioavailability and absorption of~     those three different dietary antioxidants and their combinations. The study is funded by~     Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people~     in each product group. It will be conducted on the primacies of Cambridge Theranostics in~     Babraham Research Campus. And managed by the team of experienced professionals employed by~     Cambridge Theranostics. The study will last about 12 months including recruitment process,~     screening process, periodical blood samples collection and examination and statistical~     analyses at the end.~   "
141737|NCT01199536|"~     The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to~     estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the~     end of treatment and 52 weeks from the therapy start~   "
141738|NCT01199523|"~     The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on~     ECG (electrocardiogram) measurements.~   "
141739|NCT01199510|"~     The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA®~     Lubricating Drops) plus standard of care to standard of care alone, in subjects with a~     history of intermittent eye irritation or dryness related to environmental factors and~     scheduled for routine cataract surgery.~   "
141740|NCT01199497|"~     Multicenter clinical trial, phase III, controlled by active medicine, double-blind,~     randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper~     airway characterized by non-productive cough, daytime/nighttime, with duration for at least~     3 and no more than 5 consecutive days (without systemic/topic use of medication during this~     period) followed by nasal congestion, with or without associate other nasal symptoms~     (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated~     in 2 parallel groups, and will receive the medicines of study, according of the~     randomization.~   "
141741|NCT01199484|"~     Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be~     a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is~     that SOTI should be started early in order to improve its efficacy and prevent CMPs~     sensitization from evolving towards persistent allergy. The aim of this study was to~     evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as~     a treatment alternative to elimination diet.~      Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to~     CMPs were included in this multicenter study and were randomly divided into two different~     groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the~     remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for~     one year.~   "
141742|NCT01199471|"~     This registry is primarily aiming to demonstrate the correlation between good practices of~     anesthesiologists and patient related outcomes including decreased overall anesthesia cost.~     The investigators would also like to demonstrate how the training background, and experience~     in inhalational anesthesia of the anesthesiologist influence their daily practice. At the~     end of the registry, the investigators would be able to demonstrate the influence of~     different practice pattern on patient related outcomes between the sites at which~     anesthesiologists follow modern anesthesiology practice based on their training/experience~     background and at which anesthesiologists do not follow same type of practice due to lack of~     their inhalational anesthesia training/experience.~   "
141743|NCT01199458|"~     This study evaluates the effects of adding an opioid (alfentanil) during anesthesia~     induction with respect to the barrierpressure in the esophagogastric junction.~      The secondary aim was to investigate whether the effect of cricoid pressure influences the~     barrierpressure.~   "
141744|NCT01199445|"~     The project aims to evaluate the potential impact triple fortified rice grains, mixed into~     natural rice grains, can have on vitamin A status if fed to school children in Southern~     Thailand. Within a 60 day intervention study, changes in vitamin A status in young children~     fed the fortified rice compared to children consuming non-fortified rice will be assessed.~   "
141745|NCT01199432|"~     This is a phase IV, prospective, single-center, open-label, randomized, controlled study.~     Eligible patients are randomly assigned into three groups. The investigators propose to~     evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in~     women with primary breast cancer.~   "
141746|NCT01199419|"~     The objective of the present study is to analyze the cost-effectiveness of percutaneous~     coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery~     bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the~     first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in~     114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute~     myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and~     stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up~     (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or~     CABG), clinical and angiographic procedure-related treatments during the entire FUP. The~     primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction~     of the composite of major adverse cardiac and cerebrovascular events (MACCE).~   "
141747|NCT01199406|"~     To determine the effect of combined intracutaneous infiltration and intraperitoneal~     instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic~     cholecystectomy on abdominal pain up to 24 hours after surgery.~   "
141748|NCT01199393|"~     The investigators want to research whether genetic polymorphisms of drug-metabolizing~     enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast~     cancer.~   "
141749|NCT01199380|"~     Depression related vulnerabilities are highly comorbid with smoking behavior and~     dramatically reduce cessation rates among both community and clinical samples. Previous~     research has examined the efficacy of cognitive-behavioral treatment for individuals with a~     history of major depressive disorder (MDD) in standard cessation treatment. A broader health~     impact can be achieved by targeting individuals with current elevated depressive symptoms to~     address their association with cessation failure. Thus the objective of the present proposal~     is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral~     activation intervention to standard treatment among a similar community sample of 200 adult~     smokers with elevated depressive symptoms. Participants will be followed over 52 weeks~     post-quit date and the larger sample size will allow for more complex analysis of cessation~     outcomes.~   "
141750|NCT01199367|"~     This study will determine the highest dose of KW-2450 in combination with lapatinib and~     letrozole that can be administered safely to subjects with advanced or metastatic breast~     cancer and to evaluate its effectiveness.~      This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the~     study.~   "
141751|NCT01199354|"~     The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy~     and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant~     chemotherapy and radiotherapy in invasive breast carcinoma.~   "
141752|NCT01199341|"~     The primary purpose of this study is to determine whether the treatment with AZD1981 affect~     the exposure of Warfarin.~   "
141753|NCT01199328|"~     The purpose of this study is to assess the interaction between aspirin and Nexium in healthy~     volunteers.~   "
141754|NCT01199315|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446~     in young and elderly healthy Japanese volunteers.~   "
141755|NCT01199302|"~     This study is an open label extension of study 20090072 with subjects with Crohn's disease.~     Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a~     half years. The study will be evaluated for safety and efficacy of AMG 827.~   "
141756|NCT01199289|"~     The purpose of this study is to determine if AMG 827 is effective compared to placebo as~     measured by change in Asthma Control Questionnaire (ACQ) composite scores.~   "
141757|NCT01199276|"~     The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD),~     diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip~     fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four~     days post-surgery.~   "
141758|NCT01199263|"~     This randomized phase II trial studies the side effects and how well giving paclitaxel with~     or without viral therapy works in treating patients with ovarian epithelial, fallopian tube,~     or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be~     able to kill tumor cells without damaging normal cells. Giving paclitaxel together with~     viral therapy may kill more tumor cells.~   "
141759|NCT01199250|"~     This research study is studying biomarkers in samples from patients with endometrial cancer.~     Studying samples from patients with cancer in the laboratory may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to cancer.~   "
141760|NCT01199237|"~     Protective airway reflexes may be impaired in the postoperative period, creating the~     potential for aspiration of gastric contents, even after a patient exhibits appropriate~     response to command. Because assessment of airway reflex recovery is not possible in an~     intubated patient, the clinician must make an empiric decision as to when a patient is safe~     to extubate, and choose a combination of techniques least likely to result in pharyngeal~     impairment. Adequacy of reversal of neuromuscular block by cholinesterase inhibitors (e.g.,~     neostigmine) is unpredictable, especially in the presence of profound paralysis, and tactile~     assessment of train-of four and sustained tetanus has shown poor correlation with objective~     assessments. Protective airway reflexes may also be impaired during early recovery by the~     anesthetics themselves, even when muscle relaxant has been avoided. In the absence of muscle~     relaxant the investigators previously demonstrated that patients receiving an anesthetic~     with higher tissue solubility, sevoflurane showed significantly greater impairment of~     swallowing up to 14 minutes after response to command compared to patients receiving an~     anesthetic with lower tissue solubility, desflurane. Therefore, we ask whether the~     combination of the more soluble anesthetic and the presence of neuromuscular block~     antagonized by neostigmine may create a multiplicative effect that might further prolong~     pharyngeal recovery. We plan to randomly assign 100 patients scheduled to undergo surgery~     with general anesthesia to a standardized anesthetic that includes 1) sevoflurane,~     rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group S); or 2)~     desflurane, rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group~     D). Airway reflex recovery will be judged as adequate by the patient's ability to swallow 20~     mL of water without coughing or drooling 5, 10, 15, 20, 30 and 60 minutes after response to~     command. Anesthetic (sevoflurane or desflurane) will be discontinued after administration of~     reversal agent and recovery to TOF (train-of-four) ratio of 0.7.~   "
141761|NCT01199224|"~     Compare the bioavailability of three veliparib formulations in subjects with solid tumors.~   "
141762|NCT01199211|"~     Prospective study on the structural and functional changes in the heart of adult women~     assessed by echocardiogram and in lipid metabolism that occur in response to physical~     training. Using echocardiogram we will characterize the early determinants of athletic~     remodeling. We will also assess the effect of intense physical training on lipid~     metabolism, focus on HDL subspecies and function.~   "
141764|NCT01199185|"~     Obesity represents a chronic disease associated with significant cardiovascular disease~     (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development~     of CVD risk factors. Further, there is a clear relationship between weight loss in obese~     persons and reduction in these CVD risk factors. Unfortunately, young adults are at high~     risk for weight gain. Although the scientific literature contains a number of reports~     regarding successful weight loss efficacy studies, young adults are typically~     underrepresented.~      Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting~     smoking frequently results in significant weight gain. Proactive tobacco quit lines using~     behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT)~     have been shown to help persons quit smoking. However, concerns about post-cessation weight~     gain have been reported as a significant barrier to quitting for many smokers particularly~     young adults.~      If an efficacious behavioral weight loss program could be combined with an efficacious~     behavioral smoking cessation program that prevented or significantly attenuated~     post-cessation weight gain, then a large public health benefit may result. Such a combined~     weight loss/ weight gain prevention / smoking cessation program that used targeted~     intervention strategies to young adults, removed barriers to participation, and utilize~     interactive technology should be appealing to this age group. To date such a combined~     program has not been tested in young adult cigarette smokers. Therefore, the objective of~     this clinical trial is to develop and test a behavioral weight loss / weight gain prevention~     intervention delivered through interactive technology that can be used in conjunction with~     an efficacious tobacco quit line. A total of 330 participants will be necessary to~     adequately address the following specific aims.~   "
141765|NCT01199172|"~     The proposed series addresses the prevention and treatment of voice problems in teachers.~     Data in the literature clearly identify voice disorders as teachers' primary occupational~     risk not only in the U.S. but also internationally. Moreover, voice problems constitute a~     global women's health concern. Until recently, few reports have been available around the~     treatment of these problems in teachers, and even fewer have addressed the equally important~     question of prevention. The present studies are conducted within the context of a long-range~     goal to identify effective intervention methodologies for both the prevention and treatment~     of voice problems in teachers taking into consideration multicultural and linguistic~     factors. The present studies will report pragmatic data around the effectiveness of two~     theoretically-driven approaches to the prevention and treatment of voice problems in~     teachers, (a) voice hygiene education (VH) and (b) voice hygiene education + voice~     production training in resonant voice (VH+VP, essentially the Lessac-Madsen Resonant Voice~     Therapy program). Participants will be student teachers in Pittsburgh and Hong Kong, who~     will be followed from student teaching across their second full year of employment as a~     professional teacher. The central aims are: [1] to evaluate the effectiveness of VH and~     VH+VP for the prevention of future voice problems in student teachers who are vocally~     healthy at the outset of the protocol, versus the treatment of voice problems in student~     teachers who already have them at some level; [2] to evaluate the generality of the findings~     across teachers in the U.S. and China, using appropriate linguistic and cultural adaptations~     of the interventions; and [3] to evaluate the feasibility of an internet-based voice~     exercise and reporting program as a supplement to face-to-face interventions. Ergonomic and~     personal factors will also be evaluated for their differential ability to predict the risk~     for future voice problems in teachers. The results should be useful at a practical level,~     and should also lay the groundwork for future studies assessing similar issues around the~     prevention of voice problems in teachers, in particular as influenced by multicultural~     factors within the U.S. The results should also be useful for future studies investigating~     causal pathways in interventions around these problems.~   "
141766|NCT01199159|"~     Total abdominal hysterectomy is known to be associated with operative blood loss, which can~     lead to patients' morbidity. Misoprostol, a prostaglandin, has been shown to be effective in~     reducing operative blood loss during myomectomy. It is the first study to investigate if~     preoperative misoprostol is effective in reducing operative blood loss during total~     abdominal hysterectomy.~   "
141767|NCT01199146|"~     This is a phase II, open label, single center study to evaluate the efficacy of abiraterone~     acetate (CB7630) administered to patients with castrate resistant prostate cancer who have~     experienced disease progression on ketoconazole.~      It is hypothesized that abiraterone will be active in patients who have experienced disease~     progression on ketoconazole~   "
141768|NCT01199133|"~     The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy~     (SLIT) administered to children and adolescents as allergen-based tablets once daily over a~     period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis~     symptoms and rescue medication use.~   "
141769|NCT01199120|"~     Adequate nutrition is one of the critical biological processes to learning and cognitive~     development of children. And is understandable that malnourishment affect these processes.~     Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in~     cognitive development and academic performance. However, studies have been limited.~     Therefore is of interest to know the effects that has supplement with Omega-3 for children~     8-12 years with malnutrition in a randomized, blind, placebo-controlled.~   "
141770|NCT01199107|"~     The purpose of this study is to examine the efficacy of exercise in comparison to wellness~     education to determine if they can improve the effects of prolonged exposure therapy (PE) in~     reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In~     addition, the two strategies (i.e., exercise and wellness education) will be compared in~     terms of improvements in sleep as well as levels of brain-derived neurotrophic factor~     (BDNF). BDNF is a protein that helps to support the survival of existing neurons and~     stimulate the growth new neurons and synapses. BDNF is important to learning and memory in~     general and therefore may be associated with the learning and memory as it relates to PE and~     corresponding symptom PTSD improvement.~   "
141771|NCT01199094|"~     The aim of the study is to describe patients with a high bone mass phenotype due to a~     mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age~     and sex matched controls. Moreover, bone density and microarchitecture as well as markers of~     bone metabolism are evaluated~   "
141772|NCT01199081|"~     Primary Objective:~      - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to~     different timings of Dronedarone initiation.~      Secondary Objective:~        -  Explore potential PK interaction between Dronedarone and Amiodarone~        -  Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from~          randomization up to 60 days after)~        -  To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone~          safety~   "
141773|NCT01199068|"~     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017~     administered orally twice a day in combination with erlotinib, and to assess the~     pharmacokinetics of CS-7017 in combination with erlotinib.~   "
141774|NCT01199055|"~     The primary objectives of this study are to evaluate the safety and tolerability of CS-7017~     administered orally twice a day in combination with carboplatin and paclitaxel, and to~     assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.~   "
141775|NCT01199042|"~     Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab~     polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter~     Cheyne Stokes Respiration, or Complex Sleep Apnea.~   "
141776|NCT01199029|"~     This study will investigate the effect of a single dose of PF-04308515 or prednisone on~     calculated measures of glucose tolerance and insulin resistance by using a modified oral~     glucose tolerance test.~   "
141790|NCT01198821|"~     The purpose of this study is to:~      Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.~      Determine if the combination of sodium bicarbonate and gemcitabine produces better control~     of pancreatic cancer than gemcitabine alone.~   "
141778|NCT01198990|"~     The goal of this study is to translate basic behavioral and social science discoveries into~     effective behavioral interventions that reduce obesity and obesity related morbidity in~     Black and Latino communities. This intervention will focus on promoting small changes in~     eating behavior and increasing physical activity among Black and Latino participants in~     Harlem and the South Bronx. The desired result from these activities is individual weight~     loss that will be sustained years after participation in the study.~   "
141779|NCT01198977|"~     This is a clinical trial examining a brief motivational intervention to improve adherence to~     exercise among individuals with MS to improve fatigue.~   "
141780|NCT01198964|"~     We will observe epileptic patients who already have electrodes implanted on the brain and~     are receiving high-level brain stimulation for clinical purposes while testing their motor~     and language function. We propose to do a limited, low-level brain stimulation to show that~     the signatures of local activity in the target area change as an effect of brain~     stimulation. The goal of this study is to understand the feasibility of a novel recurrent~     brain-computer interface that could eventually promote targeted functional recovery in~     subjects who have had a brain injury.~   "
141781|NCT01198938|"~     The investigators plan to evaluate the effect of postoperative melatonin administration on~     postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302~     patients older than 60, undergoing elective vascular surgery will be randomly divided into 2~     groups: treatment and control. During the first 5 postoperative days patients will receive~     sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for~     the signs of delirium, quality of sleep and severity of pain daily for the first~     postoperative week. Screening of delirium will be performed by the specially trained~     research assistant and based on the Confusion Assessment Method and the validated chart~     review. Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium~     will be compared between the groups.~   "
141782|NCT01198925|"~     Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and~     is frequently used in the empirical treatment of hospital-acquired infections because of its~     antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam~     exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor.~     Because a majority of infections are treated empirically, it is necessary to achieve a T >~     MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens,~     including those with only moderate susceptibility The aim of this study is to compare the~     same dose of piperacillin/tazobactam administered by an extended infusion versus a~     continuous infusion. A pharmacokinetic study will be performed in patients treated by~     extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading~     dose 4 G/30 min followed by 16G /24h).~      A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine~     95% probability of target attainment (PTA95) versus MIC~   "
141783|NCT01198912|"~     This is a randomized, double blind, placebo controlled, parallel group, study in patients~     with chronic rhinosinusitis with or without nasal polyps. The objective is to test the~     clinical efficacy of long-term low dose oral doxycycline on wound healing quality after~     endoscopic sinus surgery.~   "
141784|NCT01198899|"~     The purpose of this study is to determine the prevalence of Fabry mutations in patients with~     left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This~     study is a screening study~   "
141785|NCT01198886|"~     The primary objective of this study is to evaluate changes in functional status that result~     from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior~     housing facilities.~      - The primary hypothesis is that over the 6-month intervention period subjects in the~     intervention group will realize significant improvements in lower extremity function~     compared to a control group.~      Secondary objectives~      To evaluate changes in nutritional status that result from the ENP.~      - The secondary hypothesis is that subjects in the intervention group will realize~     significant increases in circulating insulin-like growth factor-1 (IGF-1) and 25-hydroxy~     vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to a control~     group.~      To evaluate changes in inflammatory status that result from the ENP.~      - Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6~     (IL-6) compared with the control group.~      To evaluate changes in psychosocial factors that result from the ENP~        -  The related hypothesis is that over the 6-month intervention period subjects in the~          intervention group will increase exercise self-efficacy, intrinsic motivation to~          exercise, and satisfaction of psychological needs compared to a control group.~        -  Additionally it is hypothesized that subjects in the intervention group will realize~          improvements in mood and quality of life compared to a control group.~      To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing~     facility setting.~   "
141786|NCT01198873|"~     Primary Objective:~      - Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the~     progression of adverse left atrial remodeling in patients with atrial fibrillation (AF)~     following 12 months of treatment.~      Secondary Objectives:~        -  Evaluate the effects of dronedarone versus placebo on left atrial function;~        -  Evaluate the effects of dronedarone versus placebo on left atrial dimension;~        -  Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF,~          E, E', A, E/E')~        -  Evaluate the safety and tolerability of dronedarone.~   "
141787|NCT01198860|"~     Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination~     plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of~     drugs derived from natural and artificial medicaments.~      Has stronger effect on immune system, effective good against HBV replication. This is a~     substantial new insight into the pathogenesis of disease, with a clear path toward clinical~     application, or which would lead to a substantial advance and perfect in management or~     public health policy.~   "
141788|NCT01198847|"~     To study whether a targeted intervention can prevent the development of overweight and~     obesity among pre-school children in families with either one obese or two overweight~     parents.~   "
141789|NCT01198834|"~     A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase~     III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine~     Topical Patch in the Treatment of Ankle Sprains~   "
141791|NCT01198808|"~     Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators~     will characterize 40 patients with muscle-invasive bladder cancer regarding the existence~     and frequency of tumorspecific T-cells and regulatory T cells. The found data will be~     correlated to clinical data such as the cancer-specific survival and the response to~     chemotherapy.~      It is hypothesized that those patients with a high number of Tregs and no tumor-specific~     T-cells have a worse prognosis.~   "
141792|NCT01198795|"~     This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in~     children 7 to 11 years of age with major depressive disorder (MDD).~   "
141793|NCT01198782|"~     The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an~     immediate treatment replacement in dry eye subjects that discontinue at least 6 months use~     of RESTASIS.~   "
141794|NCT01198769|"~     The purpose of this study is to assess immunogenicity and safety of Rotarix TM when~     administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first~     vaccination) who received Hepatitis B immunoglobulin after birth.~   "
141795|NCT01198756|"~     This study is designed to test the immunogenicity and safety of an investigational influenza~     vaccine, in children compared to two other influenza vaccines.~   "
141796|NCT01198743|"~     Cancer is a DNA disease characterized by the presence of genetics alterations in cancer~     cells.~      The recent studies underline that these recurring alterations must be considered as a good~     molecular marker. In fact, they could use for tumor DNA detection in different biological~     fluids.~      So, the main purpose is to define the presence of circulating tumor DNA in the patients~     plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and~     MIRCOSATELLIE instability).~      These molecular analysis will be done both in tumor and plasma samples,~      This trial allows to characterize the prognostic value of circulating tumoral DNA presence~     in colorectal cancer.~   "
141797|NCT01198730|"~     To determine the glucose regulation status of patients who were suspected to have CAD in~     central Taiwan.~   "
141798|NCT01198717|"~     The aim of this study is to evaluate the progression of ET in children (aged 6-17years~     inclusive) over a period of 5 years maximum. The study will also assess how children are~     diagnosed, treatment options for those children with symptoms and events related to their ET~     and the outcomes of those treatments.~   "
141799|NCT01198704|"~     Results of liver transplantation, the best theoretical treatment for HCC, are limited by~     tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However,~     these criteria are to restrictive and approximately 40% of patients denied by Milan criteria~     may be cured by liver transplantation.~      The purpose of this study was thus to prospectively evaluate factors predicting tumor~     recurrence after liver transplantation for HCC and then to reassessed criteria for liver~     transplantation.~   "
141800|NCT01198691|"~     The purpose of the study is to compare post operative pain, cost effectiveness, speed of~     closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples~     versus absorbable staples (Insorb) after Cesarean Delivery.~   "
141801|NCT01198678|"~     Currently marketed CGM sensors have an approved functional lifetime of up to 1 week.~     Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to~     accurately monitor glucose levels for 30 days. The purpose of this study is to assess the~     safety and functionality of the device in human patients for consecutive 15 days.~      GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration,~     meaning less patient interventions, and is therefore will be much more user friendly.~     Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the~     critically important hypoglycemic range, meaning that better management of patient's~     condition may be attained.~   "
141802|NCT01198665|"~     The urgent need for new effective therapy for T-cell lymphoma patients and promising results~     observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the~     investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell~     lymphoma patients.~      Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy~     for newly diagnosed peripheral T-cell lymphoma patients.~      Phase I~        1. Primary objective~           : To define the maximum tolerable dose~        2. Secondary objective~             -  To evaluate the dose-limiting toxicity~             -  To evaluate the pharmacokinetics of RAD001~             -  Pharmacogenomic profiling~      Phase II~        1. Primary objective~           : To evaluate the overall response rate~        2. Secondary objective~             -  To estimate the time to progression~             -  To estimate overall survival~             -  Pharmacogenomic profiling~   "
141803|NCT01198652|"~     This is an open, post-marketing surveillance study obtaining data retrospectively on 300~     women, of any age, treated with the BD-OTS for postpartum uterine bleeding.~   "
141804|NCT01198639|"~     A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower~     than 45) and death within 1 yr after surgery has previously been reported. In order to~     confirm or refute these findings, the investigators have designed a study which compares two~     methods of administration for total intravenous anesthesia (propofol and remifentanil):~        -  manual administration: the anesthesiologists are instructed to maintain the BIS value~          between 40 and 60.~        -  closed loop administration: an algorithm is used to maintain the BIS value between 40~          and 60.~      Based on previous studies, the amount of time that BIS is maintained above 40 is greater~     when anesthetics agents are administered using closed loop compared with manual~     administration.~   "
141805|NCT01198626|"~     The purpose of this study is to determine the efficacy, safety and tolerability of~     JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring~     hospitalization for Community-Acquired Bacterial Pneumonia (CABP).~   "
141806|NCT01198613|"~     It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with~     ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic,~     allergen-derived peptide desensitising vaccine, currently being developed for the treatment~     of ragweed allergy.~      This study will look at the efficacy, safety and tolerability of two doses of ToleroMune~     Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.~   "
141807|NCT01198600|"~     The purpose of this trial was to evaluate the factors affecting comfortable contact lens~     wear and how those factors affect contact lens replacement frequency.~   "
141808|NCT01198587|"~     Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2~     million deaths annually among children under age 5 years. Several clinical trials of oral~     zinc supplementation performed in developing country populations have confirmed this~     nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health~     Organization (WHO) has recommended global use of zinc supplementation in all children with~     diarrhea despite little or no data from trials in industrialized/developed settings. In the~     United States over 4 million children suffer annually from diarrheal illness. Although~     mortality is not a significant factor in U.S. cases, 75% of all cases present to medical~     care resulting in over 200,000 hospitalizations annually for diarrhea. This has significant~     impact on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549~     per inpatient treatment spent on each episode of acute diarrheal illness. The goal of this~     study is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea~     in children treated as outpatients and in decreasing the duration of hospitalization in~     children treated as inpatients in an industrialized country. The results of this study~     promise to have a substantial impact on the management of a common pediatric health problem,~     and could conceivably affect direct and indirect healthcare costs to society.~   "
141809|NCT01198574|"~     Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also~     in Myanmar. Both nutrient deficiencies result from interaction of several causal factors,~     and a better understanding of the etiology to interpret the prevalence and to formulate~     appropriate measures to reduce these deficiencies is necessary. There is a growing concern~     on the role of sub-clinical inflammation on the nutritional status indicators during the~     nutritional status assessment. However, there is lack of information on the role of~     inflammation on the iron supplementation. The adolescent period is a window of opportunity~     to improve the preconceptional iron status of the girls and recently gained much attention.~     The purpose of the study is to understand the role of inflammation on iron and vitamin A~     status during iron and vitamin A supplementation. The findings will show the extent to which~     iron supplementation has been hampered by inflammation and to formulate the necessary~     measures to overcome the interference.~   "
141810|NCT01198561|"~     The objective of this study is to investigate the antidepressant efficacy of rTMS, and to~     assess cortical metabolism before and after rTMS sessions in patients with major depression.~     We also aimed to investigate differences between the responders and nonresponders to rTMS~     and what would predict clinical response to rTMS.~   "
141811|NCT01198548|"~     This phase II trial is studying how well giving high-dose cholecalciferol works in treating~     patients receiving combination chemotherapy and bevacizumab as first-line therapy for~     metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of~     colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to~     them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the~     tumor. Giving cholecalciferol together with combination chemotherapy and monoclonal antibody~     therapy may be an effective treatment for colorectal cancer~   "
141812|NCT01198535|"~     The purpose of this study is to determine if a new drug, RO4929097, can work with cetuximab,~     a drug already approved for colorectal cancer, to help fight the patient's cancer. Cancers~     arise as a result of abnormal control of gene expression. One of the pathways that gets~     abnormally regulated in some cancers is the Notch pathway. RO4929097 is an investigational~     drug that blocks the activation of the Notch pathway. It is hoped that by blocking this~     abnormal activation, this drug may be helpful in patients with cancer but the investigators~     do not yet know if that is true. Cetuximab is an antibody against epidermal growth factor~     receptor and is known to have activity in metastatic colorectal cancer. Recent studies have~     shown that people with colorectal cancers that contain a mutation in a gene called K-ras do~     not benefit from receiving cetuximab. It is unknown if adding RO4929097 to cetuximab would~     benefit patients who have tumors with this mutation.~   "
141813|NCT01198522|"~     Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal~     impact on the survival of patients. Even with the application of more potent~     gemcitabine-based regimens, survival of more than 1 year is uncommon for advanced disease.~     Accordingly, there is substantial unmet needs for the improvement of treatment options. The~     combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could~     result in improved anti-cancer efficacy, based on preliminary clinical and strong~     preclinical data.~      The primary purpose of this Phase I study is to define a safe and potentially more active~     treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced~     pancreatic cancer patients. Also, early signs of anticancer responses of the~     L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine~     monotherapy).~   "
141814|NCT01198509|"~     Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and~     damage. RA attacks the lining of the joints (synovium), causing swelling that can result in~     aching and throbbing, and eventually deformity. Even though there have been many advances in~     the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors~     still do not know what causes this inflammation in joints. It is likely that RA occurs as a~     result of a complex combination of factors, including a person's genes; lifestyle choices,~     such as smoking and diet; and things in a person's environment, including bacteria or~     viruses. This study investigates the hypothesis that bacteria living in a person's mouth~     and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid~     Arthritis. The investigators believe that by killing those bacteria with antibiotics, they~     might be able to understand how the immune system works and, maybe, what causes RA.~   "
141832|NCT01198275|"~     The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone~     and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus~     rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).~   "
141833|NCT01198262|"~     The purpose of this study is to determine whether the Cepheid GeneXpert system accurately~     detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and~     wound swabs.~   "
141815|NCT01198496|"~     1. Objectives and Hypothesis~             1. Objectives:~                This study evaluates whether strict BP management is useful for the prevention of~               recurrent stroke.~                Hypertensive patients with history of stroke are treated with stepwise multi-drug~               therapy to achieve stricter BP target <120/80 mmHg in the strict BP control group~               and less stricter BP target <140/90 mmHg or <130/80 mmHg for patients with current~               DM/CKD/MI in the standard BP control group. The participants under the BP~               treatment achieving their respective BP target will be followed for recurrence of~               stroke. The study continues until the number of patients with the first recurrent~               stroke reaches a total of 330 between the two groups. The occurrence rates of~               recurrent stroke will be compared between the two groups.~             2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control~               group having lower BP target: <120/80 mmHg* than in a standard BP control group~               having BP target <140/90 mmHg or <130/80 mmHg for current DM/CKD/MI in patients~               with hypertension.~        2. Study design This will be a multicenter, randomized, open-label study. The study~          consists of a screening period, a titration period and a follow-up period. The~          screening period is a period between the date of consent and the enrollment date.~          Hypertensive patients with history of stroke are randomly assigned to either the strict~          BP control group having the target of <120/80 mmHg or the standard BP control group~          having the target of <140/90 mmHg without current DM, CKD or MI and <130/80 mmHg with~          current DM, CKD or MI. The titration period is the period finding a treatment which~          achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise~          multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel~          blocker and aldosterone antagonist. The participants will be observed under the BP~          management for their respective BP target. The study will be continued until the number~          of patients with the first recurrent stroke reaches a total of 330 between two groups.~          The follow-up period will be 3 years.~      The recurrent rates of stroke in both groups will be compared from various aspects, and~     strict BP management will be investigated on the usefulness in prevention of recurrent~     stroke.~   "
141816|NCT01198483|"~     The purpose of this study is to compare refractive outcomes after two different types of~     combined cataract surgery, namely microinscision cataract surgery and smallincision cataract~     surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal~     disorders and coexisting cataracts.~   "
141817|NCT01198470|"~     The purpose of this investigation is to evaluate the safety and effectiveness of the~     TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from~     Degenerative Disc Disease (DDD) at one level from L1 to S1.~   "
141818|NCT01198457|"~     Adherence (or compliance with) a medication regimen is generally defined as the extent to~     which patients take medication as prescribed by their health care providers. The adherence~     to medications has close relation to effectiveness of the therapy. The primary objective of~     this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of~     days covered, number of days in which clodronate is taken according to treating physician~     recommendation) in patients with malignancy. The secondary hypothesis generating objective~     is to describe the relation between adherence to treatment with oral clodronate and efficacy~     of the therapy (skeletal events, pain).~   "
141819|NCT01198444|"~     Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives~     efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral~     treatment. The aim of the study is to evaluate in everyday practice the relation between~     dosage errors and indicated factors, potentially influencing the compliance with the dosing~     scheme.~   "
141820|NCT01198431|"~     The main aim of this study is to examine the effects of restricted sleep on energy and~     substrate metabolism as well as relevant hormonal systems that might be involved in the~     underlying mechanisms.~      The investigators hypothesize that short-term sleep curtailment in adolescents is~     accompanied by 1) increased hunger and desire to eat; 2) increased spontaneous energy~     intake; 3) reduced spontaneous physical activity; and 4) increased fluctuation in hormones~     in a way that could favour a positive energy balance and potentially weight gain on the long~     run.~   "
141821|NCT01198418|"~     This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more~     information about the methods that are used on the internet to provide information on how to~     reduce the risk of giving or getting infections that are often or usually passed from one~     person to another during sexual or intimate contact (sexually transmitted infection (STI)).~     STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop~     methods that will allow someone who is living with HIV an easy way that they can get~     information and learn of ways on their own that can decrease their chances of getting~     sexually transmitted infections and ways that they can reduce the chance that they may~     transmit HIV to others.~   "
141822|NCT01198405|"~     To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined~     with guideline-driven standard treatment on patients documented with and/or at high risk of~     coronary artery disease.~   "
141823|NCT01198392|"~     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin~     versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced~     gastric cancer.~   "
141824|NCT01198379|"~     The study is prospectively initiated to: (1) evaluate the alterations in platelet function~     to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney~     disease undergoing hemodialysis, and (2) compare the incidence of vascular events~     (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or~     revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant~     and aspirin-sensitive patients.~   "
141825|NCT01198366|"~     AERAS-402 will be given to infants of at least 16 weeks of age who have already been~     vaccinated with BCG to determine if AERAS-402 will increase protection of infants to~     tuberculosis.~   "
141826|NCT01198353|"~     This study is designed with the aim to evaluate the clinical effect of the overlapped~     switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.~   "
141827|NCT01198340|"~     To evaluate an analgesic effect without basal administration of local anesthetics for~     patient-controlled femoral nerve block (with sciatic nerve block) after total knee~     arthroplasty.~   "
141828|NCT01198327|"~     This study evaluates long-term safety in patients with macular edema due to Retinal Vein~     Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed~     in the HORIZON extension trial.~   "
141829|NCT01198314|"~     Long-term immunosuppression carries potential adverse effects such as risk of infection,~     malignancy, renal insufficiency, diabetes and hypertension. In clinical liver~     transplantation, some liver transplant recipients maintain allograft function without~     immunosuppressive drugs. This is called as operational tolerance. Many attempts have been~     made to identify immunological biomarkers predicting operational tolerant patients.~     Therefore, the investigators aimed to identify patients who have the potential to be~     operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop~     ultimately with monitoring of biomarkers.~   "
141830|NCT01198301|"~     The investigators want to develop a gene expression profile the for prediction the~     chemotherapeutic response of patients with metastatic breast cancer.~   "
141831|NCT01198288|"~     This study will investigate if adding a domiciliary respiratory physiotherapy treatment to~     standard care in patients with chronic obstructive pulmonary disease (COPD) can improve~     physical function (walking test) and quality of life.~   "
141835|NCT01198236|"~     Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients~     receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients~     with a history of invasive fungal infection (IFI) are at high risk of developing relapse and~     fatal complications.~      Prompt intensive antifungal therapy, have improved responses and survival, allowing an~     increase of antifungal treatments, including secondary antifungal prophylaxis.~      Few studies have addressed the role of previous IFI in the feasibility of stem cell~     transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of~     infection after transplantation. However, given the lack of prospective studies, the role of~     secondary antifungal prophylaxis remains unclear.~      Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans,~     non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides,~     Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma~     spp. and various kinds of yeast fungi and mycetes.~      The role of itraconazole IFI prophylaxis treatment has been proved by many interventional~     studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will~     be given at standard dose to patients undergoing allogeneic stem cell transplantation or~     chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of~     itraconazole secondary prophylaxis.~   "
141836|NCT01198223|"~     The aim of the present study was to compare the effect of aqueous extract of garlic with~     nystatin mouthwash in denture stomatitis.~   "
141837|NCT01198210|"~     The immediate postoperative period after tonsillectomy, , is often difficult. These children~     frequently have severe pain but postoperative airway edema along with increased sensitivity~     to the respiratory-depressant effects of opioids may result in obstructive symptoms and~     hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but~     these drugs may be associated with increased bleeding after this operation.~      Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each.~     Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone~     (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg~     dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per~     tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label.~     A computer-generated table of numbers guided randomization. Modified Hannallah pain scale~     [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation~     and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients~     were interviewed on the day after surgery to assess the postoperative pain, nightmares,~     hallucinations, vomiting and bleeding. All the children were premedicated with midazolam~     hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with~     thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and~     nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique~     for all cases and hemostasis done with bipolar cutter. At the end of the surgery~     neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg~     intravenously), anesthesia was discontinued and the tracheal tube removed in the operating~     room when patients were deep. After extubation the patients were taken to the postanesthesia~     care unit (PACU) where an nurse who were unaware of the study drug observed the patients.~     The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of~     anesthesia until the patients opened their eyes on command) and time to the first~     administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total~     1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score >~     4 or who were crying during two consecutive five minute observation periods until the child~     was comfortable. Postoperative pain during the first 24 h was assessed using a four-point~     scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents.~     In the ward the standardized postoperative analgesic technique was with acetaminophen supp~     (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for~     pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid~     pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and~     vomiting, bleeding, sleep disturbance and nightmares that the child might have had as~     surgery were assessed during a telephone follow up 24 h later.~   "
141838|NCT01198197|"~     Background:~      - A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved~     in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers~     are interested in testing a new radioactive chemical that will help locate NOP receptors in~     the brain during imaging studies such as positron emission tomography (PET) scans. Because~     this chemical has not yet been approved by the Food and Drug Administration, it is~     considered to be an experimental drug.~      Objectives:~      - To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging~     studies of the nociceptin/orphanin FQ peptide (NOP) receptor.~      Eligibility:~      - Healthy volunteers between 18 and 50 years of age who are able to have imaging studies.~      Design:~        -  This study will involve three or four outpatient visits to the National Institutes of~          Health Clinical Center. All participants will be screened with a full physical~          examination, medical history, blood and urine tests, and electrocardiogram.~        -  Participants will be involved in one or more parts of this three-part study as directed~          by study researchers. Part 1 consists of brain imaging to study how the brain responds~          to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is~          distributed throughout the body after being administered. Part 3 is a set of testing~          and retesting scans to determine how precise the drug is in locating the NOP receptors~          in the brain.~        -  Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the~          study drug will be administered and participants will have a brain PET scan. Blood~          samples will be taken during the PET scan, and urine samples will be taken after the~          scan. These tests will take up to 3 hours to perform.~        -  Part 2: Participants will have a whole body PET scan that will last a maximum of 3~          hours.~        -  Part 3: Participants will receive the study drug and have two additional PET scans.~          Blood samples will also be taken during this part.~   "
141839|NCT01198184|"~     This phase I trial is studying the side effects and best dose of giving~     gamma-secretase/Notch signalling pathway inhibitor RO4929097 and temsirolimus together in~     treating patients with advanced solid tumors. Gamma-secretase/Notch signalling pathway~     inhibitor RO4929097 and temsirolimus may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
141840|NCT01198171|"~     This research study is studying racial and genetic biomarkers of response in tissue samples~     from patients with endometrial cancer. Studying samples of tissue from patients with cancer~     in the laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how~     well patients will respond to treatment.~   "
141841|NCT01198158|"~     This randomized phase III trial studies giving everolimus together with bevacizumab to see~     how well it works compared to everolimus alone in treating patients with advanced kidney~     cancer that progressed after first-line therapy. Everolimus may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow~     and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking~     blood flow to the tumor. It is not yet known whether giving everolimus together with~     bevacizumab is better than everolimus alone in treating patients with advanced kidney cancer~     that has progressed after first-line therapy.~   "
141842|NCT01198145|"~     RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing~     pelvic radiation therapy.~      PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works~     in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation~     therapy.~   "
141843|NCT01198132|"~     The aim of this multicentre, randomised, double-blind, placebo-controlled study is to~     evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin~     D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.)~     interferon beta-1a 44 µg (Rebif) 3 times weekly. The subjects will be divided into 2 groups,~     one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the~     other group will be on placebo along with Rebif treatment. A total of 200 subjects will be~     recruited in 20-30 centres in France.~   "
141844|NCT01198119|"~     This study evaluates the feasibility of the NBI technique in the detection of early cancer~     lesions.~   "
141845|NCT01198106|"~     BACKGROUND:flight simulator have become an important component in pilot training. However,~     they are known to be associated with motion sickness like symptoms defined as Simulator~     Sickness (SS). Prevention countermeasures against motion sickness have been studied~     extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies~     emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on~     prophylaxis against SS is sparse.~      OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or~     placebo for SS prevention in helicopter pilots.~      DESIGN: a prospective, placebo controlled double-blind.~      SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.~      PARTICIPANTS: IAF experienced helicopter pilots.~      INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before~     beginning of a 3 sortie simulator training~   "
141846|NCT01198093|"~     The objective of this study is to present evidence-based medicine for development of~     clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild~     cognitive impairment(MCI) in korea~   "
142133|NCT01194427|"~     This research study is designed to look at the effects of the combination of vorinostat~     (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The~     investigators will do this by comparing tissues from the original breast biopsy to tissues~     obtained after taking vorinostat and tamoxifen for 2 weeks.~   "
141847|NCT01198080|"~     Avascular necrosis is a disease where there is cellular death (necrosis) of bone components~     due to interruption of the blood supply. Without blood, the bone tissue dies and the bone~     collapses. If avascular necrosis involves the bones of a joint, it often leads to~     destruction of the joint articular surfaces. Avascular necrosis is especially common in the~     hip joint. A variety of methods are now used to treat avascular necrosis the most common~     being the total hip replacement, or THR.A new, more promising treatment is hip resurfacing~     or metal on metal (MOM) resurfacing.Another treatment is utilization of bone marrow derived~     stem cells.these stem cells can provide angiogenic factors and osteogenic cytokine to~     improve angiogenesis and bone formation.~   "
141848|NCT01198067|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given to patients with relapsed or refractory WM. The safety of~     this drug will also be studied.~      This is an investigational study. Pomalidomide is FDA approved and commercially available~     for the treatment of certain types of MM. Its use in this study is investigational.~      Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.~      I~   "
141849|NCT01198054|"~     The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in~     patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5~     (-5), who obtained complete remission after conventional induction chemotherapy. So, too,~     for those who no obtained response treatment (total resistance) or partial remission.~      At the same time, the study evaluate the security of lenalidomide.~   "
141850|NCT01198028|"~     The goal of this clinical research study is to learn if erlotinib can help to control~     squamous cell carcinoma that has either come back or has spread. The safety of this drug~     will also be studied.~   "
141851|NCT01198015|"~     Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good~     appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The~     pathological mechanism is barely understood. Although feeding difficulties may play a role~     in this, other constitutional factors as altered metabolic processes are suspected.~     Preliminary research showed elevated plasma creatine concentrations and increased urinary~     creatine/creatinine ratios in half of the RTT girls.~      The aim of this study is to confirm previous findings and examine the functionality of the~     creatine transporter in RTT girls.~      The investigators assume that previous findings will be confirmed, and are due to an altered~     functionality of the creatine transporter.~   "
141852|NCT01198002|"~     The primary purpose of this study is to help answer if LY2127399 is safe and effective in~     the treatment of rheumatoid arthritis while on a background treatment of methotrexate.~      This study is comprised of 3 periods:~      Period 1 - 52 week blinded treatment~      Period 2 - additional 48 week unblinded treatment~      Period 3 - 48 week post treatment follow up~   "
141853|NCT01197989|"~     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using~     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar~     pustulosis present for at least one year.~   "
141854|NCT01197976|"~     The purpose of this study is to evaluate the efficacy of a special sock, manufactured using~     TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar~     psoriasis present for at least one year.~   "
141855|NCT01197963|"~     The purpose of the study is to determine if by performing surgery we can cure Type II~     Diabetes.~      The surgical procedures:~        1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction~          of caloric intake and rapid gastric emptying.~        2. ileal transposition which involves repositioning a 150cm segment of the ileum into the~          jejunum causing improved glucose homeostasis.~   "
141856|NCT01197950|"~     The purpose of this study is to evaluate the effect of manual acupuncture and~     electro-acupuncture on labour pain.~   "
141857|NCT01197937|"~     The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a~     website that allows patients and providers to maintain contact via the website. We will~     compare RMS users on a number of different variables with the goal of identifying which~     variables are associated with optimal outcomes (larger weight losses) at one year (and~     potentially beyond). The study has two primary objectives. The first is to assess changes in~     body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that~     frequent users will achieve significantly greater reductions in weight at 6 and 12 months~     (and beyond) than infrequent users. The second objective is to assess changes in body weight~     at postoperative year 1 in persons who use different features of the RMS site. We~     hypothesize that persons who, on a regular basis, record their food intake, track their~     physical activity and make specific behavioral goals will experience significantly greater~     reductions in weight beginning 6 months after surgery as compared to those who do not use~     these features of the RMS site.~   "
141858|NCT01197924|"~     The medulloblastome is a tumour of the child relatively frequent usually sitting in the~     cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these~     children present cognitive disorders and in particular disorders of the working memory~     associated with a fall with the school performances. By studying a troop of 32 children, we~     could show that the disorders of the working memory prevail during the handling of~     information presented visually and with verbal contents. However, the specific engagement of~     the cerebellum in the tasks of working memory according to the sensory method of~     presentation (visual or auditive) and the nature (verbal or not verbal) of information to~     treat vague remainder. Moreover, the anatomical attacks associated with these disorders~     remain ignored in these children. The best comprehension of the bases anatomo-functional~     calculuses which underlie their cognitive deficits is essential to develop new strategies of~     treatment and rehabilitation.~      Objectives:~        -  To describe in IRMf of the common and specific networks engaged during the execution of~          the tasks of working memory according to the sensory type and the nature of information~          to be memorized.~        -  To describe in IRMf the cortical reorganizations necessary to the execution of the~          mnemic tasks among patients.~        -  To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and~          cerebral, cortical and subcortical associated with these disorders.~        -  To study the correlations radio-private clinics between data IRM and the data~          neurological and neuropsychological of the children explored according to protocol~          ONCORAP~   "
145572|NCT01149226|"~     Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane~     Anesthesia in Day-case Pediatric Surgery~   "
141859|NCT01197911|"~     This open-label study will assess the effects of hepatic impairment on the pharmacokinetics~     of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment~     (Child-Pugh class A or B) and in matched control subjects with normal hepatic function.~     Subjects will receive a single oral dose of aleglitazar, with assessment of the~     pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled~     subject is approximately 6 weeks.~   "
141860|NCT01197898|"~     The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds~     following 14 days of treatment with Santyl or its vehicle base.~   "
141861|NCT01197885|"~     IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma.~     Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect~     (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct~     mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is~     to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients~     suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the~     lower esophagus.~   "
141862|NCT01197872|"~     Gene Security Network has developed a novel technology called Parental Support (PS) which is~     used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization~     (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the~     uterus, which have the best chance of developing into healthy children.~   "
141863|NCT01197846|"~     Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12~     weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment~     with no more than two concomitant mood stabilizers at stable doses and current subsyndromal~     symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases~     would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).~   "
141864|NCT01197833|"~     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and~     may cause discomfort. In this study, patients with varicose veins in the legs will be~     participating. The purpose of this research study is to evaluate the safety and~     effectiveness of two different doses of an investigational drug, Polidocanol Endovenous~     Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat~     treatment in subjects with varicose veins.~   "
141865|NCT01197820|"~     Several technological challenges exist to apply Magnetic Resonance guided High Intensity~     Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges~     related to the motion of these organs. This study tests a new software to improve~     thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same~     time, the trajectory of the target in 3D is analyzed.~   "
141866|NCT01197807|"~     Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants,~     including vigorous infants in the delivery room, has been featured as a standard of newborn~     care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the~     recommendation for routine suctioning of infants following delivery, provided they are not~     depressed or in need of immediate resuscitation. However, this new alternative~     recommendation was based on a small randomized trial and other lower level evidence rather~     than evidence from larger trials. The NRP Textbook cautions against vigorous suctioning~     because of the resultant apnea or bradycardia. Furthermore, suctioning may delay other more~     important steps of resuscitation. Thus, it is necessary to compare the alternative~     recommended practice, i.e. simple wiping of the mouth, to determine if it has equivalent~     efficacy and a favorable side effect profile compared to suctioning.~   "
141867|NCT01197794|"~     The study will assess the efficacy, safety and tolerability of AZD1981 compared to~     non-active compound in asthmatic patients.~   "
141868|NCT01197781|"~     This Study evaluates the possible drug interaction between FosD and verapamil when taken~     together.~   "
141869|NCT01197768|"~     The purpose of this study is to evaluate the efficacy and feasibility of a multi-level~     self-management intervention to improve nutritional intake in a group of homebound older~     adults (HOAs) who are at especially high risk for undernutrition. The study will be guided~     by the theoretical approaches of the Ecological Model and Social Cognitive Theory and will~     use a prospective randomized controlled design to estimate whether individually tailored~     counseling focusing on social and behavioral aspects of eating results in increased caloric~     intake and improved nutrition-related health outcomes in a sample of 104 HOAs. The~     investigators hypothesize that intervention at these levels will improve caloric intake and~     indirectly improve health outcomes.~   "
141870|NCT01197755|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study~     will last for approximately six months.~   "
141871|NCT01197742|"~     The Sweetheart register (Risk management of Diabetics with acute myocardial infarction)~     documents both the prevalence of pathologic glucose metabolism in consecutive high-risk~     patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute~     and long-term therapy. Furthermore the register will provide data about the implementation~     of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.~   "
141872|NCT01197729|"~     OPTAMI documents the characteristics of consecutive patients with acute STEMI and NSTEMI in~     hospital everyday-life in Germany, their acute and adjuvant medication treatment, events~     until discharge (e.g. mortality, stroke, re-MI), and their medication for secondary~     prevention at discharge.~      In the follow up-period of one year, information is collected concerning events as~     mortality, stroke, re-MI, coronary interventions (PCI, CABG) and re-hospitalisation.~      The implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. The~     usefulness of the European standard for data acquisition in cardiology (CARDS = Cardiology~     Audit and Registration Standards) is evaluated.~   "
141873|NCT01197716|"~     The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data~     concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a~     Follow-up via telephone is conducted after 3 months.~   "
142160|NCT01193907|"~     This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations~     of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with~     the currently licensed Vi polysaccharide vaccine~   "
141876|NCT01197677|"~     1. The main aim of the first specific protocol initiated by the European CMR registry,~          suspected CAD, is to demonstrate that patients presenting for work up of suspected~          coronary artery disease, which have a completely normal CMR scan will have a low risk~          for cardiovascular events.~        2. The main aim of the second specific protocol initiated by the European CMR registry,~          HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic~          cardiomyopathy(HCM).~        3. This registry is sought to collect data on the general use of CMR in the European~          clinical practice, its safety and its therapeutic implications in a high number of~          cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical~          questions worth to be investigated in detail as additional specific protocols in the~          future.~   "
141877|NCT01197664|"~     This randomized pilot clinical trial studies the side effects of giving paricalcitol~     together with fluorouracil and radiation therapy in treating patients with rectal cancer~     that can be removed in surgery. Paricalcitol may help rectal cancer cells become more like~     normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to~     kill tumor cells. It not yet known if chemotherapy and radiation therapy are more effective~     with or without paricalcitol in treating rectal cancer~   "
141878|NCT01197651|"~     The aims of the aorta-stent-Registry are:~      • participating hospitals (with audit) document all consecutive patients diagnosed with a~     disease of the distal thoracal aorta that receive one of the following therapies:~   "
141879|NCT01197638|"~     The goal of this register is the documentation of the success as well as of the~     complications regarding interventional therapy of cardiac arrhythmia by catheter ablation.~     This is the necessary basis for quality management and development of possible improvements~     of catheter ablation.~   "
141880|NCT01197625|"~     In this study the investigators will include patients with high risk of PSA relapse~     scheduled to receive curative surgical treatment. This include patients with high Gleason~     score (9-10) or micrometastatic disease (tumor cells detected in specimens obtained from~     bone marrow). They are scheduled for regular follow-ups with PSA measurements. We have~     previously published that some patients with metastatic prostate cancer may respond to~     DC-vaccination with tumor mRNA, with a decrease in PSA. PSA response is related to~     immunological response. Patients receiving DC-vaccination may have a reduced risk of PSA~     relapse or increased time to PSA relapse. Previous experience with different DC-vaccine~     protocols in our hospital has resulted in only minor side-effects (grade 1-2 fever, rubor,~     fatigue, local swelling or pain).~   "
141881|NCT01197612|"~     That high-dose steroid applied to the nasal cavity immediately post-operatively will improve~     olfaction and healing following endoscopic sinus surgery.~   "
141882|NCT01197599|"~     The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit~     training on the upper extremity of persons with spinal cord injury and able-bodied controls.~   "
141883|NCT01197586|"~     Establishing new biochemical markers in the differential diagnostics and risk stratification~     in heterogeneous patient collectives is becoming more and more important. The markers should~     be objective, reliable, reproducible, quick and cost effective as well as specific and~     sensitive. Concerning the differential diagnostics of dyspnea, NT-pro-BNP plays the most~     important role for the evaluation of a cardiac origin. However, a corresponding biochemical~     marker for pulmonary stress is lacking. The aim of the study at hand therefore was the~     evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac~     diseases.~   "
141884|NCT01197573|"~     The waiting list for kidney and liver transplantation continues to increase in the United~     States, and therefore the need grows for additional donor organs. Utilization of organs~     donated after cardiac death (DCD) could be one way to increase organ availability, however~     there are risks associated with poorer clinical outcomes, including delayed graft function~     and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that~     delayed graft function and ITBS events may be related to small blood clots (microthrombi)~     that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with~     a thrombolytic agent prior to implantation may reduce post-transplant morbidity and~     mortality, and may ultimately result in a greater number of transplantable livers and~     kidneys.~   "
141885|NCT01197560|"~     The purpose of this study is to compare lenalidomide to a control drug and see which one~     delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.~   "
141886|NCT01197547|"~     This is a clinical registry of an FDA approved device system called the Genesys Hydro~     ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be~     inserted, by a trained physician, into the uterus, where it will fill and circulate fluid~     that is warm enough to change the characteristics of the uterine lining. This is done with~     the anticipated result of improving menstrual bleeding symptoms.~      The purpose of this FDA-mandated registry is to obtain clinical experience on the use the~     Genesys HTA™ system, under normal clinical conditions, and document its safety and technical~     reliability.~   "
141887|NCT01197534|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1~     year.~   "
141888|NCT01197521|"~     The purpose of the study is to evaluate the effectiveness of two dosing regimens of~     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking~     methotrexate but not responding. The study will last for 1 year.~   "
141889|NCT01197508|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a~     medicine tablet or capsule, but contains no active medicine) is safe and effective when~     taken together with another antidepressant.~   "
141890|NCT01197495|"~     The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R)~     Ultra XC Injectable Gel for lip augmentation~   "
141979|NCT01196338|"~     The primary objective of the investigators randomized controlled trial is to determine if~     early protected weightbearing and ankle range of motion after surgical treatment (open~     reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work~     and functional outcome compared to postoperative ankle immobilization in a non-weightbearing~     cast.~   "
141891|NCT01197482|"~     Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)~      Objectives: To explore if inhalative fluticasone application by means of the AKITA~     technology would result in a better symptom control in patients with severe persistent~     asthma as compared to inhalative application of fluticasone by a conventional MDI.~      Study design: open label, cross-over (one AKITA, one MDI arm)~      Patients: 20 Patients with severe persistent asthma~   "
141892|NCT01197469|"~     The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise~     capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary~     hypertension.~   "
141893|NCT01197456|"~     More than two million American women are breast cancer survivors. Approximately one-third of~     these women are premenopausal at diagnosis and face issues related to reproduction as they~     undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on~     breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire~     for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian~     function in breast cancer survivors could significantly impact physicians and patients in~     counseling, medical and surgical treatment choices, and consideration of fertility~     preservation options.~      The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian~     imaging markers that can predict ovarian failure and characterize the course of ovarian~     function after chemotherapy. The investigators plan to follow a group of young women from~     breast cancer diagnosis to five years after chemotherapy. The investigators will study the~     following risk factors: blood hormone levels that reflect ovarian function, genetic~     mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg~     count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related~     to risk of ovarian insufficiency singly. After examining these individual risk factors for~     ovarian failure, the investigators will put them together into an Ovarian Failure Clinical~     Predictive Index. This index will be a tool similar to the Gail Model that can be used to~     determine individual risk for ovarian failure. This tool would assist young breast cancer~     patients and their physicians in making treatment decisions that would impact cancer~     survival and reproduction.~   "
141894|NCT01197443|"~     The overall intent of this study is to explore a promising mode for delivering treatment for~     childhood obesity via parent education only, and to evaluate the cost effectiveness compared~     to the current gold standard treatment of parent-and-child dual education.~   "
141895|NCT01197430|"~     Purpose: Optimal eye-hand coordination is important for volleyball players. Neck disorder~     may affect neck function and subsequently eye-hand coordination. The purpose of this study~     is to explore the vertical stability training effects on coordination of the upper~     extremities of female volleyball players.~      Methods: This study surveyed 25 players of a volleyball team, randomly assigned into the~     group A (training 1st) and group B (training 2nd). The group A includes 13 volleyball~     players and the group B includes 12. Eye-hand coordination was tested by a self-developed~     hand-stroking table device and stay time and motion time of upper extremities were~     determined. There are two testing modes, regular and random. Motion time for the electric~     probe moving between target sensor and stay time for the electric probe staying on a target~     sensors were collected for each mode, before each session of training and after the end of~     the 2nd session. In the 1st session of training, group A started vertical stability training~     and group B did control training for six weeks. In the 2nd session of training, the training~     programs were shifted between group A and B for another six weeks.~   "
141896|NCT01197417|"~     The purpose of this study is to determine the safety and efficacy of intravenous magnesium~     in shortening the duration of a pain crisis and to determine the health-related quality of~     life and short term outcomes of children treated with intravenous magnesium during an acute~     pain crisis.~   "
141897|NCT01197404|"~     Adolescents are at risk for HIV because of sexual and drug use behavior initiated during~     early adolescence, and those with mental health problems appear to be particularly~     susceptible. Problems with managing emotions may make it difficult for early adolescents to~     make good decisions about sexual and substance use behaviors. This project will develop and~     evaluate interventions for early adolescents with mental health issues. An intervention~     focused on teaching affect management skills will be compared to an intervention addressing~     a variety of health topics to determine which intervention best reduces risk behavior among~     this at-risk population.~   "
141898|NCT01197391|"~     This study will test the safety and tolerability (how the body reacts to the drug) of~     REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy~     subjects. The study drug and placebo will be administered by subcutaneous injection (under~     the skin) at the clinic visit. There will be 14 clinic visits, which will include 4~     overnight stays. Subjects will be monitored by the study staff for side effects and the~     body's response to the study drug. Vital signs (blood pressure, temperature, breathing and~     heart rate) will be checked, blood and urine samples will be collected at some or all~     visits.~   "
141899|NCT01197378|"~     Cystinosis is an inherited disease that if untreated, results in kidney failure as early as~     the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)~     which must be taken every six hours for the rest of the patient's life to prevent~     complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being~     studied to see if it may be able to be given less frequently, once every 12 hours, and have~     similar results to four times a day Cystagon®.~   "
141900|NCT01197365|"~     The purpose of this study is to determine the safety and efficacy of an infant formula~     supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in~     improving the gastrointestinal health and immune response in healthy term infants.~   "
141901|NCT01197352|"~     Young adults are in a critical period where they can be influenced to avoid a trajectory of~     high-risk drinking and harmful outcomes in the later adult years. The Emergency Department~     might offer a unique opportunity to reach young adults, if an easy to implement screening,~     brief intervention and referral to treatment was available. The investigators are~     investigating the feasibility and accuracy of ED-initiated and outpatient-continued~     assessment of drinking behavior in young adults using a computer-driven text messaging~     platform. Based on the subject's response to weekly assessments, the computer platform will~     send personalized motivational messages in real-time.~   "
142161|NCT01193894|"~     This study aim to investigate the effect of Profermin versus Fresubin in the dietetic~     treatment of active ulcerative colitis.~   "
141902|NCT01197339|"~     The purpose of this study is to generate a technology that will allow clinicians to~     prescribe behavioral treatment that should optimize tissue healing for both acute and~     chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology~     for estimating overall mechanical dose during phonation, and component metrics of phonatory~     mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed~     imaging data and aeromechanical modeling, for a range of vocal fold configurations~     (Experiment 1); (2): identify mathematical relations between treatment dose parameters,~     inflammatory state of the tissue and time-varying biological consequences in the tissue, up~     to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid~     physical-biological model of vocal fold inflammation and treatment to identify treatment~     modalities that should optimize post-traumatic wound healing at 2 wk, for a range of acute~     phonotraumatic conditions (Experiment 3—no human subject involved), and (4): provide a~     preliminary test of the hybrid treatment models' ability to predict idealized treatment~     outcome in human subjects, and calibrate the model as needed iteratively to achieve a match~     between predicted and obtained outcomes (Experiment 4).~   "
141903|NCT01197326|"~     The purpose of this study is to assess if, compared with standard paper-based systems, an~     automated Early Warning System (EWS) resident in a spot check patient monitor, can help to~     identify deteriorating patients.~   "
141904|NCT01197313|"~     Anxiety and depression are often present in patients with chronic heart failure (CHF). This~     study aimed to evaluate the influence of anxiety and depression on the physical function,~     disability, and quality of life (QOL) in CHF. This study examined the effects of 8-week~     home-based exercise on these parameters, and investigated the correlations between these~     outcome changes.~   "
141905|NCT01197300|"~     This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and~     efficacy of zoledronic acid twice yearly in osteoporotic children treated with~     glucocorticoids.~   "
141906|NCT01197287|"~     There are three elements to this study:~        -  Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned~          in healthy volunteers.~        -  Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of~          QAK423 are planned in COPD patients.~        -  Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.~      Repeat dosing is planned in COPD patients.~   "
141907|NCT01197274|"~     The purpose of this study is to compare the results skin prick tests using simple blood~     lancet (Vitrex®) with DuoTips among mite-sensitized subjects.~   "
141908|NCT01197261|"~     The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects~     suffering from severe pain due to Bladder Pain Syndrome.~   "
141909|NCT01197248|"~     Up to 50% of patients undergoing pelvic floor repair experience short-term postoperative~     voiding dysfunction, increasing the length of hospitalization, cost and anxiety among~     patients.~      The mechanism behind this problem is the sutures placed in the pubocervical fascia during~     the cystocele repair. The cited benefit of bladder plication is greater cure of cystocele.~     The existence of pubocervical fascia and the need for placement of plicating sutures over~     the bladder have been questioned.~      The objective of this study is to determine if avoiding cystocele plication in women~     undergoing surgery for cystocele decreases the need of catheterization beyond post operative~     day #2.~      We will conduct a RCT of patients undergoing transvaginal repair of midline cystocele at the~     Mount Sinai Hospital. Patients will be randomized to receiving plicating sutures versus no~     plication. This procedure may be conducted with or without concomitant correction of other~     sites of prolapse. However, they will not have any procedures for correction of stress~     incontinence.~      This study will be powered to detect a reduction in voiding dysfunction from 50% to 25% of~     patients. Using a χ2 distribution, and an alpha error of 0.05, the required sample size is~     58 patients per group.~   "
141910|NCT01197235|"~     The purpose of this study is to determine whether the drug that produce red blood cells is~     effective in the prevention of kidney dysfunction after coronary angiography in patients~     with chronic kidney disease.~   "
141911|NCT01197222|"~     Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to~     the internal abdominal wall at the beginning of a surgical case and remains in position~     until completion of the surgery, enabling the surgeon to clean the camera lens without~     removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy~     and safety of using the EndoClear device as a laparoscopic lens cleaning device.~   "
141912|NCT01197209|"~     This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label,~     dose-escalation trial for prostate cancer patients with high risk of local recurrence after~     radical prostatectomy. Patients entered into this trial will have Prostate Cancer of~     Clinical stage T1c, T2 or T3 with a Gleason Score of between 7 (4+3) and 10 at the time of~     enrollment. Patients will receive three 1 mL injections (3 mL total volume) of Ad-REIC/Dkk-3~     into the prostate prior to undergoing a radical prostatectomy. Three patients will be~     treated at each dose level unless a dose-limiting toxicity (DLT) is observed or MFD (defined~     as 1 x 10e12 vp/treatment) is achieved with expansion for up to 6 more patients at the MTD~     or MFD.~   "
141913|NCT01197196|"~     This study involves a randomized controlled trial to test the efficacy of behavioral weight~     loss as a treatment for migraine in obese females aged 18 to 50 years. The primary aim is to~     examine whether participants assigned to a behavioral weight loss treatment condition report~     greater pre- to post-treatment reductions in migraine headache frequency than participants~     assigned to a migraine education condition.~   "
141914|NCT01197183|"~     This observational survey with prospective and/or retrospective follow-up is designed to~     study practices for the initial treatment of hypothyroidism in France without modifying~     subject treatment.~   "
141915|NCT01197170|"~     The goal of this clinical research study to find the highest tolerated dose of anastrozole~     alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib~     (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients~     with advanced cancer. The safety of these drug combinations will also be studied.~   "
142162|NCT01193881|"~     This phase I trial studies the side effects and best dose of gamma-secretase/Notch~     signalling pathway inhibitor RO4929097 (RO4929097) and erlotinib hydrochloride when given~     together in treating patients with non-small cell lung cancer that is stage IV or has come~     back. RO4929097 and erlotinib hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
141916|NCT01197157|"~     The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the~     sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is~     peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype.~      However, this approach is not sufficient to substantially improve the sustained virologic~     response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C~     virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum~     infection, recently was shown to have an unexpected antiviral activity in the HCV replicon~     system and in chronically infected patients.~      The aim of this work is to study impact of nitazoxanide therapy in addition to~     peginterferon/ribavirin combination on virologic responses in patients with chronic~     hepatitis C genotype 4.~      Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2~     groups:~      Group A: comprises 100 CHC patients who will receive the standard of care treatment,~     peginterferon-alf 2a plus weight-based ribavirin for 48 weeks.~      Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of~     500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide~     500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks.~      Data will be collected and statistical analysis will be done comparing the groups regarding~     response to antiviral therapy. Final results will be discussed and compared to similar~     studies published in peer reviewed journals and international conferences.~   "
141917|NCT01197144|"~     The purpose of this study is to obtain increased knowledge concerning central pain and~     fatigue processing in rheumatoid arthritis, and how these conditions are influenced by~     treatment with Tumor Necrosis Factor (TNF) blockade with adalimumab.~   "
141918|NCT01197131|"~     Deviation of hormone formation within nerve cells and nerve system provides autism spectrum~     disorder and neurodevelopment retardation through interaction of steroids with~     neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear~     steroid receptors.~      Urinary steroid metabolites will be compared between children with autism spectrum disorder~     and healthy controls.~   "
141919|NCT01197118|"~     Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains~     poor despite potentially curative resections. Complete surgical resection is the only~     potentially curative therapy available to patients with gastric cancer. However, even after~     a complete resection with negative margins, many patients will experience recurrence. In~     recent years, the radiation therapy in the carcinoma of the stomach represents a new issue~     that should be addressed accompanying the development of radial physics and radial biology,~     the clinical application of computed tomographic (CT) simulation and digital reconstitution~     technique, especially the application of 3-dimensional conformal and intensity modulated~     radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to~     cause a significant improvement in overall and disease-free survival according to Intergroup~     Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative~     sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve~     survival for advanced gastric cancer.~   "
141920|NCT01197105|"~     The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a~     natural product (Schinus terebinthifolius) used by children with gingivitis.~   "
141921|NCT01197092|"~     A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can~     demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as~     well as its risk factors.~   "
141922|NCT01197079|"~     The objectives of this study are:~        1. to determine the degree of understanding and perceived risks for human papillomavirus~          (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and~          identify potential barriers to HPV vaccine access and utilization in a population of~          young men who have sex with men (MSM) (under 26 years of age)and in parents of boys~          aged 9 to 18 years~        2. to determine HPV vaccine acceptance and predictors of acceptance in a population of~          young MSM and in patients of boys ages 9 to 18 years~        3. to develop strategies to overcome potential barriers to vaccination and improve vaccine~          access and utilization via development of targeted educational initiatives.~   "
141923|NCT01197066|"~     This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and~     efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in~     patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) #~     101-KOA-0801i.~   "
141924|NCT01197053|"~     This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and~     efficacious for desensitizing children with peanut allergy.~   "
141925|NCT01197040|"~     A multicenter, randomized, double-blind, prospective study will be performed to evaluate the~     efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose~     steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). Two~     hundred patients will be included in this study. They will be randomly assigned to a double~     blind treatment with either prednisone~      1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The~     outcome will be compared during one-year follow up~   "
141926|NCT01197027|"~     The purpose of this study is to evaluate the acceptability and feasibility of an enhanced,~     individual-level counseling intervention for individuals in the acute and early phase of HIV~     infection aimed at reducing risk behaviors.~   "
141927|NCT01197014|"~     Study Design :~      - A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,~     crossover study~   "
141928|NCT01197001|"~     Study Design :~        -  A single center, open, randomized, single dose, two-period, two-treatment,~          two-sequence, crossover study~      Primary Objective:~        -  To assess the bioequivalence of combination oral formulation of amlodipine/losartan~          versus two co-administered products containing amlodipine and losartan~   "
141929|NCT01196988|"~     This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK)~     Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to~     describe safety and immunogenicity of the GSK Biologicals' investigational vaccine~     GSK2321138A in children aged 6 to 35 months.~   "
141930|NCT01196975|"~     This study is designed to test the immunogenicity and safety of an investigational influenza~     vaccine, in adults compared to two other influenza vaccines.~      This study will also evaluate the lot-to-lot consistency of three vaccine lots.~   "
141931|NCT01196962|"~     There is no randomized controlled trial to compare the rates of complications associated~     with internal jugular and subclavian venous catheterization. The aim of this study is to~     compare mechanical, infectious, and thrombotic complications of internal jugular and~     subclavian venous catheterization. An improved understanding of CVC-related risks might help~     clinicians to choose one approach over the other in specific clinical settings.~   "
141932|NCT01196949|"~     It is hypothesized that a combination approach would produce increased clinically and~     statistically significant outcomes as opposed to standard single intervention, inclusive of~     comparatively greater reduction in pain, improvement in range of motion, proprioception and~     function with an associated quicker recovery time.~      Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal~     system. Various individual treatment options have previously been compared to one another in~     clinical trials, however there is paucity of literature with regards to combined treatment~     choices versus individual therapy. The purpose of this study is to investigate the relative~     effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the~     management of CAI.~      The study will be conducted as a single blinded randomised and comparative clinical trial at~     Cleveland Chiropractic College and Durban University of Technology.~   "
141933|NCT01196936|"~     Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen~     citrate may fight breast cancer by blocking the use of estrogen by the tumor cells~      This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast~     cancer risk in radiation-induced cancer survivors.~   "
141934|NCT01196923|"~     The purpose of this study is to confirm the safety and effectiveness of the CardioFocus~     Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.~   "
141935|NCT01196910|"~     The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD~     symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare~     this to the effect of sham DTMS on ADHD adults~   "
141936|NCT01196897|"~     This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure~     Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2~     stroke risk stratification score of 1 or greater. This is a prospective, non-randomized~     study to evaluate the initial use of the next generation WATCHMAN Device.~   "
141937|NCT01196884|"~     Primary ITP has wide heterogenous biology, presentation and response to therapy.~      The immune-genetic assessment of ITP may help to identify differences among patients with~     ITP and optimize the therapeutic choice.~   "
141938|NCT01196871|"~     The purpose of this study is to determine the effects of AT1001 on the safety of agalsidase,~     and the effects of agalsidase on the safety of AT1001.~   "
141939|NCT01196858|"~     During the 1990s, evidence began to emerge of the long duration of untreated illness prior~     to receiving treatment for patients with psychotic disorders. Studies across the world on~     first episode psychosis have consistently found an average of 1 - 2 years between the onset~     of psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate~     implications such as unnecessary distress for patients and families, and may also compromise~     potential recovery when treatment is initiated.By understanding how and why substantial~     delays occur the investigators may be able to better design interventions to facilitate~     better earlier treatment. The components of DUP can be conceptualised as comprising 3~     distinct intervals: help-seeking delay, referral delay and delay in mental health services.~     In this study the primary aim is to establish the level of DUP in nordland, and explore the~     components of this variable. Help-seeking delay will be investigated by interviewing~     patients presenting at the central mental health hospital in Nordland about their psychosis~     onset and pathways to care. Referral delay will be investigated by a questionnaire about the~     referral pratices among GPs in Nordland. Delays in mental health services will be~     investigated by focus group interviews with leaders and professionals at the 7 community~     mental health centers in Nordland. This knowledge is believed to be crucial for developing~     services that can reduce DUP and give this patient population earlier access to adequate~     treatment.~   "
141940|NCT01196845|"~     The main objective of this study is to evaluate the decrease of inflammation of adipose~     tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by~     continuous positive airway pressure (cPAP).~      An interim analysis will be performed when 40 patients will be included.~   "
141941|NCT01196832|"~     Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by~     both bronchial inflammation and remodelling.~      Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition,~     the number of eosinophils can be also increased during exacerbation.~      Airway remodelling is an abnormal tissue repair following bronchial inflammation, which~     contributes to none reversible pathological features, such as bronchial and peri-bronchial~     fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely~     unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung~     fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their~     involvement in COPD airway remodelling remain unknown.~   "
141942|NCT01196819|"~     The purpose of this randomized study is to evaluate new generation of MicroPort's DES of its~     safety, efficacy and delivery system in treating CAD.~      The end point is to observe in-stent late lumen loss after 9 months of the stent~     implantation. The second end point is to study in-stent percent diameter stenosis.~      This study is based on non-inferior assumption (vs. Xience V DES), requiring both end points~     reach statistical significance.~      Prespecified OCT follow-up is planned at 3-Year after index PCI at 3 chosen hospitals.~   "
141943|NCT01196806|"~     The purpose of this study is to compare Measurements of Arterial Blood Pressure by L&T NIBP~     Module With Invasive Arterial Blood Pressure in Neonates.~   "
142005|NCT01196000|"~     RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for~     rectal cancer and may have fewer side effects and improve recovery. It is not yet known~     whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in~     treating patients with rectal cancer.~      PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see~     how well it works compared to laparoscopic surgery in treating patients with rectal cancer~     that can be removed by surgery.~   "
142006|NCT01195987|"~     The purpose of this study is to study the role of the Immune System in causing arthritis in~     patients with Hepatitis C.~   "
141944|NCT01196793|"~     A significant number of children 0 to 5 years of age are seen in paediatric Accident &~     Emergency departments (A&E) with feverish illness. Most of these patients could safely be~     managed in a primary care setting, particularly with guidelines in place on how to optimally~     assess these children. Some patients, however, will require admission, either because of a~     potentially serious underlying disease or because of other factors, for example parental~     concern or difficulties in communication because of language barriers. An increase in the~     number of children attending A&E departments with feverish illness as well as a rise in the~     volume of admissions has been noted over time. To enable an appropriate adaptation of acute~     medical services for children an in depth understanding of the assessment and admission~     processes is crucial.~      This study primarily aims to describe factors associated with hospitalisation of children~     aged 3 months to 5 years presenting with fever to an urban paediatric A&E departments by~     describing and analysing characteristics both of those patients admitted to hospital and~     those managed in the community. To complement this, information on the short-term healthcare~     utilization by families attending the emergency department because of feverish illness will~     be collected. The study will be carried out in one participating centre in Switzerland and~     the United Kingdom, respectively, to enable a head to head comparison of the assessment and~     admission practices in two European countries. The resulting data will be used as the basis~     for further research in this area and will provide information on how to optimally structure~     service provision in acute febrile childhood illness.~   "
141945|NCT01196780|"~     This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab)~     in patients with active rheumatoid arthritis who have had an inadequate response or are~     intolerant to anti-TNF therapy. Data will be collected from patients initiated on~     MabThera/Rituxan therapy according to standard of care in routine clinical practice. For~     each patient data will be collected for 92 weeks.~   "
141946|NCT01196767|"~     This is a prospective double-blinded and randomised study involving patients undergoing~     cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr~     continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters~     inserted at the lateral edges of the sternum will be studied, versus a control group in~     which normal saline will be infused in the same conditions.~   "
141947|NCT01196754|"~     This is a prospective clinical monocentric study in ICU with sedated ventilated patients~     with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model~     of sevoflurane.~   "
141948|NCT01196741|"~     The purpose of this study is to investigate whether the addition of the Src inhibitor~     saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus~     placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also~     determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib~     should proceed to a phase III trial.~   "
141949|NCT01196728|"~     The primary objective of this study is to assess the safety and tolerability of the~     Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc)~     doses in patients with T2DM.~   "
141950|NCT01196715|"~     REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte~     Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome~     (MDS).~      After giving Informed Consent patients will undergo a number of tests to confirm~     eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the~     three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim~     (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a~     month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they~     may continue on the treatment regime up to 52 weeks. After week 24 all patients will be~     required to attend the clinic twice more, at week 36 and 52.~      Patients will be followed for a further 5 years to record loss of response, transformation~     to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.~   "
141951|NCT01196702|"~     The purpose of this study is to discover if differences in the surface markers of B-cells~     (antibody producing cells of the immune system) in Common Variable Immune Deficiency (CVID)~     are related to CVID or its complications/treatment (e.g. bronchiectasis, granulomatous~     disease, immunoglobulin treatment).~      The study hypothesis is that the altered B-cell surface markers are related to CVID, and not~     to the complications or treatment of CVID.~   "
141952|NCT01196689|"~     The purpose of this study is to study pharmacokinetics in adolescents.~   "
141953|NCT01196676|"~     This is a single ascending dose study to assess the safety, tolerability and~     pharmacokinetics of AZD4451.~   "
141954|NCT01196663|"~     This Clinical study is preformed in order to estimate the performance of the TMS thermometer~     and to make a final tuning of the thermometer mathematical algorithm.~      Body temperature of men, women and children will be measured using the TMS thermometer.~      Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal~     thermometer as a reference.~   "
141955|NCT01196650|"~     This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in~     patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The~     study will compare 2 formulations of the IN 10 003 to placebo~   "
141956|NCT01196637|"~     Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases~     under the pectoralis minor muscle in the infraclavicular region of the shoulder. The~     hypothesis is that ultrasound imaging can be used to visualize brachial plexus compression~     and distortion of the pectoralis muscle during arm activity, such as abduction, and that~     normal subjects will not demonstrate any plexus compression or muscle distortion.~   "
142007|NCT01195974|"~     This study is a two-period, double-blind study in healthy adult female subjects. Each~     subject will participate in an oral contraceptive Run-in period prior to the treatment~     periods. The length of the Run-in Period will be 28 days or longer, depending on the timing~     of the subject's menstrual cycle and on whether the subject is taking an OC. Each subject~     will participate in this run-in period (if needed), followed by two treatment periods.~     Treatment Periods 1 and 2 must be conducted successively. Subjects will be randomized in a~     cross-over fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch~     GSK2248761 or placebo for another 10 days. Subjects will return to the study center for~     final follow up evaluations 7 - 14 days after the final dose of study medication.~   "
141957|NCT01196624|"~     Subjects~      Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD will be~     recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental~     Health Center. Patients will complet a course of 10 daily rTMS sessions.~      After receiving a full explanation of the procedures, all subjects will sign a written~     informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion~     University.~      Study Design~      The study suggested here will recruit 40 patients with DSM-IV PTSD also demonstrating at~     least moderately severe flashbacks. Each of the subjects will be recruited randomly to one~     of 4 groups:~        1. Right DLPF Rtms (10Hz) co-administered with neutral visual and/or auditori stimuli;~        2. Right DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli~          mimicking experiences appearing during the patients flashbacks;~        3. Left DLPF Rtms (10Hz) co-administered with neutral visual and or auditori stimuli;~        4. Left DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli~          mimicking experiences appearing during the patients flashbacks;~      Treatment Characteristics~      rTMS will be performed with a Magstim stimulator (Magstim Company, Whitland, U.K.) The motor~     threshold was determined in each subject once, before treatment. This was defined as the~     lowest stimulation intensity capable of inducing a visible movement at least five times out~     of 10 stimulations.~      The position of the right dorsolateral prefrontal cortex will be defined as 5 cm anterior~     (in a parasagittal line) to the motor cortex. The stimulus intensity will be 80% of the~     patient's motor threshold intensity.~      Treatments will be given for 20 minutes per day over 10 working days. Both subjects received~     high-frequency rTMS) received 10 Hz for 2 seconds per train; the intertrain interval was 58~     seconds. For each participant the stimulus was administered over the right dorsolateral~     prefrontal cortex.~      Rating Scales~      The ratings of PTSD symptoms, anxiety, and depression willm be carried out by an expert~     investigator who will be blind to the stimulation condition. The patients will be assessed~     at four time points—before TMS (baseline), at day 5, at day 10, and at day 24 (14 days after~     the intervention). The instruments used will be as follows:~      The PTSD Checklist The Treatment Outcome PTSD Scale The Hamilton Anxiety Rating Scale The~     Hamilton Rating Scale for Depression PTSD symptoms were assessed by using the Hebrew version~     of the Clinician-Administered PTSD Scale.~   "
141958|NCT01196611|"~     The study compares two different approaches of voice therapy. Vocal Functional Exercises~     (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II -~     Tecnisystem do Brasil TSI 1210). Both approaches combined with Vocal Hygiene Program~     (Behlau, 2007).The target population are female teachers because they have the highest risk~     for developing voice problems. For this study the investigators are primarily interested in~     seeing if Vocal Functional Exercises and Voice Amplification are equally effective at~     improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic~     evaluation will be done before randomization. All the participants will complete before and~     after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an~     instrument designed to appraise the self-perceived psychosocial consequences of voice~     disorders to assess the impact of voice disorders on daily activities (b) Audio voice~     recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice~     Program (c) Audio recording for later perceptual analysis through Consensus~     Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search for~     evidence in clinical studies like this can contribute to awareness programs and vocal~     training for teachers.~      H1 - Both approaches produce positive voice changes, but the VFE will produce more changes.~     H2 - Only VFE are effective for teachers with voice disorders.~      H3 - Both approaches produce similar changes. H4 - Null Hypothesis.~   "
141959|NCT01196598|"~     To verify if pelvic floor muscle training program and/or a hypopressive exercise program~     could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor~     muscle strength.~   "
141960|NCT01196585|"~     This study aims to compare the diagnostic efficiency and reliability of Abrams' needle~     pleural biopsy under computerized tomography guidance with that of cutting-needle pleural~     biopsy under ultrasonography guidance in patients with pleural effusion.~   "
141961|NCT01196572|"~     The purpose of this study is to determine whether laser internal urethrotomy (IU) is as~     efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures~     regarding post operative urination outflow, stricture recurrence rate and possible post-~     operative complications~   "
141962|NCT01196559|"~     The purpose of this study is to evaluate the objective response rate and safety in~     platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients~     treated with vinorelbine and gemcitabine combination chemotherapy.~   "
141963|NCT01196546|"~     This study will assess the efficacy and safety of combination therapy of~     vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000~     mg/day.~   "
141964|NCT01196533|"~     1. Aim:~           The aim of the clinical trial is to study the accuracy of the TensorTip device compared~          with registered (FDA-approved) invasive and non-invasive devices.~        2. Hypothesis:~      Human physiological biomarkers may be measured from the color distribution of the internal~     or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on~     the color distribution of the peripheral blood tissue, which enables the measurement of~     certain biomarkers and vital signs under consideration.~   "
141965|NCT01196520|"~     Burkitt lymphoma (BL) is an aggressive monoclonal B-cell malignancy that is rare (sporadic)~     worldwide, but is 100-fold more common (endemic) in equatorial Africa, particularly among~     children. Epstein-Barr virus (EBV) and malaria are epidemiologically linked to endemic BL in~     epidemiologic studies, but questions remain about role of EBV variants and the evidence for~     association with malaria is weak. EBV is ubiquitous, yet only few children develop BL,~     possibly because only a few EBV variants are pathogenically relevant. The association of BL~     with malaria is based on ecologic and non-comparative clinical studies. Two case-control~     studies have reported significant association of high anti-malarial antibodies with BL~     (OR=5_ among children in Uganda and in Malawi, but selection bias (cases and controls came~     from dissimilar geographical areas) and reverse causality bias were limitations. Three~     studies were conducted in the 1960s and 70s to test association of carriage of~     malaria-resistance gene with BL, two of which reported a significant or marginal inverse~     association. These pioneering studies were small (240 cases all together) and looked at one~     polymorphism in one gene (sickle cell gene). Improvements in technologies to characterize~     genetic variation allow the EBV and malaria hypotheses to be examined with greater power by~     looking at genetic variation across multiple genes.~      Epidemiology of Burkitt lymphoma in East African children and minors (EMBLEM) is a~     case-control study of 1500 BL cases and 3000 age-, sex- and residence-frequency matched~     controls we are proposing to conduct in East Africa. The study will enroll cases at four~     hospitals in four regions in East Africa, where malaria transmission is holoendemic and year~     round. The controls will be enrolled from general population attendees at Health Center II~     (HC-II) units where the cases originated. The primary study objectives are: 1) to test the~     hypothesis that genetic resistance to malaria is associated with a lower risk of BL, and 2)~     to use genome-wide association methods to discover genetic variation that may be associated~     with decreased or increased risk of BL. Because genetic variation conveys no information on~     actual exposure to malaria or EBV, in secondary analyses, we will use empiric~     epidemiological questionnaire and laboratory methods: a) to measure exposure to malaria and~     its association with BL, and b) to measure EBV variants and their association with BL. To~     examine issues related to bias and to obtain data to correct for deviations, we will also~     enroll 2250 population controls from 5% of the villages to obtain population distribution of~     key exposures variables. This data will be used to reweight the distribution in HC-II~     controls back to the general population.~   "
141966|NCT01196507|"~     Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal~     varices with or without red color signs and have not bled previously will be enrolled. After~     baseline evaluation, the participants will be randomized to receive either Placebo or~     Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The~     primary endpoint of the study is the the proportions of patients who develop large varices~     (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in~     HVPG,change in CTP and MELD score& adverse events.~   "
141967|NCT01196494|"~     INTRODUCTION: There are several alternatives for one-stage emergency treatment of~     obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon~     lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure~     prior to scheduled surgery. At present, it is not clear whether emergency perioperative~     lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and~     primary anastomosis is equal safe or even safer than placement of a stent as a temporary~     measure prior to scheduled surgery, less length of stay and less cost.~      OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the~     point of view of morbimortality, economic cost, and long-term survival.~      MATERIAL AND METHODS:~      Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were~     divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A~     simple randomization system was used. The estimated sample size required per group was 21~     patients. Demographic variables, risk prediction models, postoperative morbimortality,~     staging, complications due to the placement of stent, surgical time, clinical follow-up,~     health costs and follow-up of survival were recorded.~   "
141968|NCT01196481|"~     Patients of cirrhosis will be enrolled who have large esophageal varices, which have never~     bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be~     measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to~     6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous~     pressure gradient (HVPG) will again be measured to find out responders (hepatic venous~     pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure~     gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The~     responders will be excluded from the study while the non responders will be randomize into~     carvedilol+VSL#3 versus Endoscopic Variceal Ligation.~   "
141969|NCT01196468|"~     In Europe many patients infected with HIV remain undiagnosed, although this percentage~     varies between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed~     HIV results in increased morbidity and mortality and reduced treatment response, as~     appropriate health interventions are delayed. It also has adverse public health~     implications, with those individuals unaware of their HIV status being more likely to~     transmit the virus.~      An important public health issue is how to diagnose more individuals with HIV earlier in the~     course of their infection. In the US, the Centre for Disease Control and Prevention (CDC)~     has introduced testing guidelines whereby all individuals are tested, unless they object, at~     any point of contact with the healthcare system - the opt-out testing guidelines.~      At the HIV in Europe Conference held in November 2007, the consensus, which included~     patient and public involvement, was that such an approach would not be suitable for Europe.~     The Conference recommended further development of focused HIV testing in patients presenting~     with certain clinical conditions and diseases - the indicator disease'' testing guidelines.~      Cost effectiveness analyses suggests cost savings if a screened population has an HIV~     prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very~     little - if any - evidence regarding HIV prevalence for certain conditions and diseases in~     specific and easy to identify sections of society. The focus of attention is on those~     conditions and diseases which occur more frequently in individuals known to be infected with~     HIV.~      The aim of this study is to assess HIV prevalence for several diseases and conditions,~     within a specific segment of the population not yet diagnosed with HIV, who present for care~     with that specific disease or condition. These conditions have been selected as they occur~     frequently in individuals already diagnosed with HIV infection. This is a pilot study to~     inform phase two, which will involve more diseases and conditions with a wider participation~     of centres across Europe.~   "
141970|NCT01196455|"~     This is an open-label, non-comparative efficacy and safety study of Capecitabine and~     Mitomycin C as first-line treatment in patients with previously untreated metastatic breast~     cancer.~   "
141971|NCT01196442|"~     RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness~     caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain~     therapy in treating chronic pain and numbness caused by chemotherapy in patients with~     cancer.~   "
141972|NCT01196429|"~     This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line~     therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian~     cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an~     effective treatment for ovarian cancer.~   "
141973|NCT01196416|"~     This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch~     signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and~     temozolomide and to see how well they work in treating patients with recurrent or metastatic~     melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with~     combination chemotherapy may kill more tumor cells.~   "
141974|NCT01196403|"~     RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor~     than is used in standard surgery. It is not yet known whether minimal-access surgery to~     remove the bladder is more effective than standard surgery to remove the bladder in treating~     patients with bladder cancer.~      PURPOSE: This randomized phase II trial is studying standard surgery to see how well it~     works compared with minimal-access surgery in treating patients with bladder cancer.~   "
141975|NCT01196390|"~     This randomized phase III trial studies how well radiation therapy, paclitaxel, and~     carboplatin with or without trastuzumab work in treating patients with esophageal cancer.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,~     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of~     tumor cells to grow and spread. It is not yet known whether giving radiation therapy and~     combination chemotherapy together with or without trastuzumab is more effective in treating~     esophageal cancer.~   "
141976|NCT01196377|"~     Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for~     personalized medicine by identification of treatment-response phenotypes that are important~     determinants of outcome. The Specific Aim of this study is to determine the feasibility of~     this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different~     albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr.~     Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.~   "
141980|NCT01196325|"~     The study will investigate changes in the structure and function of blood vessels in the~     front and back of the eye following laser and anti-VEGF treatments for sight-threatening~     diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control~     subjects and diabetic patients who require conventional or contemporary treatment for~     pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment~     using state-of-the-art techniques to measure vision, the rate of blood flow and structure at~     the front and back of the eye and the effectiveness of blood flow delivery. Changes~     following treatment in these novel, non-invasive techniques will be quantified and~     described. We anticipate that conventional and new / developing treatments will lead to~     narrowing of the vessels and consequent reduction of blood flow at the back and front of the~     eye. There will be a strong relationship between structural changes of the eye and~     functional changes of blood vessels at the front and back of the eye. The results of this~     study will improve our understanding of the impact of the various treatments on the entire~     eye. The research will also ensure an improved understanding of the mechanisms of action of~     the various treatments and will provide insight of reasons for good or poor outcomes, based~     upon specific changes in structure and blood flow.~   "
141981|NCT01196312|"~     Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and~     above levels of anxiety sensitivity that will involve the testing of a specialized protocol~     for improving treatment retention and outcomes for heroin dependent individuals in a~     residential substance use treatment. ASTH-HR will integrate established treatment modules~     such as Healthy Relationships, along with interoceptive exposure, affect management, and~     psycho-education exercises developed for anxiety prevention and treatment programs with~     standard substance use treatment.~   "
141982|NCT01196299|"~     This project aims to study the prognostic ability of various MRI imaging markers in the~     evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at~     each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison~     to the TBI patients.~      It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional~     connectivity, and tissue microstructure will be related to the clinical status of the~     patient, as well as their social and occupational outcomes.~   "
141983|NCT01196286|"~     The goal of this study is to determine whether pairing multifamily group psychoeducation~     with cognitive remediation may facilitate improved outcomes among individuals with~     recent-onset psychosis.~   "
141984|NCT01196273|"~     HIV-infection is associated not only with a reduced function of the immune system, but also~     linked with diseases of other organ systems, in particular with the heart.~      Heart conditions that have been described with HIV include~        -  Pericarditis,~        -  Pleural effusion~        -  Pulmonary hypertension (Venedic classification typ II)~        -  Dilated cardiomyopathy~        -  Heart failure~        -  Myocarditis~        -  Bacterial endocarditis~        -  Heart valve disorders In addition to previously stated disorders of the heart, the~          premature atherosclerosis of coronary arteries, a further even more important disease~          of the heart in this patient population, went into the focus of most HIV-researchers~          and physicians.~      Premature atherosclerosis of coronary arteries results in coronary calcification, angina~     pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk~     for a variety of heart-related conditions, including coronary artery disease. It is assumed,~     that HIV infection doubles the risk of a heart attack, according to recent research.~      The reason for this link between HIV and heart-related conditions is unknown, but secondary~     infections that affect the heart muscle and coronary arteries have a greater chance of~     occurring in people with compromised immune systems. In addition, the HI-virus itself had~     been detected in the myocardium and might have an impact on the premature of cardiovascular~     diseases.~      Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy,~     ART) are assumed to have heart-related side effects.~      Therefore, current treatment regimens for HIV infection have to be balanced against the~     marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart~     disease should be integrated into current treatment procedures of HIV-infected patients.~      The link between the heart and HIV is well established but not well understood. Therefore,~     further results are needed for efficient guidelines for the prevention, diagnostic and~     therapy of HIV-associated cardiovascular diseases.~   "
141985|NCT01196260|"~     This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the~     treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved~     by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of~     drugs is experimental (not approved by the FDA as standard treatment), but is a widely used~     treatment option and preliminary studies have shown that treatment with the combination has~     a positive effect on metastatic colorectal cancer.~   "
141986|NCT01196247|"~     The purpose of the study is selecting second line therapy for patients with pancreatic~     cancer using molecular profiling will improve 1 year survival.~   "
141987|NCT01196234|"~     This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for~     2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor~     receptor (EGFR) mutations.~      Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d~     Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.~   "
141988|NCT01196221|"~     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify~     the plaque composition and lipid content of plaques and will have the potential for repeated~     in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a~     screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC).~     For plaque composition imaging by MRI the researchers aim to increase scan resolution and~     decrease scan time. For quantifying plaque lipid content the researchers aim to develop an~     MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque~     composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have~     carotid artery plaques.~   "
141989|NCT01196208|"~     The purpose of this study is to provide the option of brentuximab vedotin treatment to~     eligible patients in studies SGN35-005 and C25001~   "
141990|NCT01196195|"~     The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice-~     and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1~     infected children who are currently taking lopinavir/ritonavir as part of their combination~     antiretroviral therapy and who are currently achieving virological suppression (<50~     copies/ml). Specifically:~        -  To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of~          twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight~          and comparing to historical adult and paediatric data of pharmacokinetics of~          lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).~        -  To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with~          once-daily dosing in the same children.~        -  To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to~          twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and~          acceptability will also be compared.~   "
141991|NCT01196182|"~     Congenital heart defects (CHD) are the most common major human birth malformation, affecting~     ~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and~     are second only to infectious diseases in contributing to the infant mortality rate. Current~     understanding of the etiology of pediatric cardiovascular disorders is limited.~      The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center,~     prospective observational cohort study. Participants will be recruited from the Pediatric~     Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B)~     Program. Biological specimens will be obtained for genetic analyses, and phenotype data will~     be collected by interview and from medical records. State-of-the-art genomic technologies~     will be used to identify common genetic causes of CHD and genetic modifiers of clinical~     outcome.~      To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA)~     and genetic data, along with detailed, phenotypic and clinical outcomes data in order to~     investigate relationships between genetic factors and phenotypic and clinical outcomes in~     congenital heart disease.~   "
141992|NCT01196169|"~     This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared~     to another one which is vancomycin when given around the time of joint replacement surgery.~     Vancomycin is recommended for perioperative prophylaxis in methicillin resistant~     Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty.~     Daptomycin has not been recommended for this indication but it is FDA approved for treatment~     of MRSA blood stream and skin and soft tissue infections. Data collected during this study~     may support the use of daptomycin for this indication and may also be used for other~     research purposes that have not yet been specified.~   "
141993|NCT01196156|"~     This non-interventional study for prospective follow up of a cohort of 220 subjects born~     small for gestational age (SGA) is planned for the purpose of finding out if normalisation~     of adult height is associated or not with metabolic alterations and if true, their magnitude~     and relevance as well as to detect warnings throughout the treatment period that may be~     useful for prevention or therapy. This study would help in answering the question if the SGA~     and growth hormone (GH) association results in insulin resistance and if affirmative, who~     develops it as well as its impact on other metabolic parameters that precedes type 2~     diabetes.~   "
141994|NCT01196143|"~     This is a phase IV non-interventional, multicentric observational study to evaluate the~     baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count~     (AFC) and age as prognostic factors of the outcome of the in-vitro~     fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving~     Gonal-f for controlled ovarian hyperstimulation (COH).~   "
141995|NCT01196130|"~     The goal of this clinical research study is to test for biomarkers in patients with~     metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical~     markers in the tumor tissue and/or blood that may be related to your reaction to cancer~     drugs.~   "
141996|NCT01196117|"~     Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of~     salivary cortisol and alpha-amylase levels prior to use of placebo and continuous positive~     airway pressure (CPAP) and will evidence a decrease in these levels after consistent use of~     continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of~     sleepiness will also decrease with the use of CPAP therapy and will correlate with the~     levels of salivary cortisol and alpha-amylase in relation to their subjective sleepiness~     scale, Psychomotor Vigilance Test (PVT), and pupillometry.~   "
141997|NCT01196104|"~     This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy~     and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin~     glargine versus insulin aspart in combination with insulin glargine in subjects with type 2~     diabetes.~   "
141998|NCT01196091|"~     The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two~     different doses of LY2127399 administered in addition to standard of care therapy in~     patients with active SLE.~   "
141999|NCT01196078|"~     This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in~     chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be~     randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1~     and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study~     treatment is until disease progression.~   "
142000|NCT01196065|"~     This open-label, fixed sequence, two-period study will assess the effect of memantine on the~     pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect~     of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will~     receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a~     washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment~     Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks~     after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.~   "
142001|NCT01196052|"~     This single-arm open-label study assessed the safety, feasibility, and efficacy of~     trastuzumab emtansine (T-DM1) after the completion of anthracycline-based~     adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer.~     Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17~     cycles.~   "
142002|NCT01196039|"~     This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is~     designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to~     patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.~   "
142003|NCT01196026|"~     This study is designed to assess the immunogenicity, reactogenicity and safety following~     vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been~     vaccinated with two doses of Pandemrix at the age of 6 months-9 years.~   "
142004|NCT01196013|"~     The purpose of this study is primarily to assess the safety, tolerability and~     pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with~     relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with~     greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)~     clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to~     document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)~     promoter polymorphism on PK and treatment outcome.~   "
142008|NCT01195961|"~     Background:~      - Developmental dyscalculia is a learning disability in which individuals have difficulty~     learning or comprehending mathematics or other number concepts (such as keeping score during~     games, measuring time, or estimating distance). Developmental dyscalculia affects certain~     parts of the brain that are required for processing numbers. Research has shown that a form~     of brain stimulation called transcranial direct current stimulation (tDCS), applied when~     healthy individuals are being trained to carry out tasks with numbers, improved the ability~     to process numbers and solve math problems. More research is needed about whether tDCS can~     improve number processing in people with developmental dyscalculia.~      Objectives:~      - To examine whether the effects of transcranial direct current stimulation can help~     individuals with developmental dyscalculia perform mathematical calculations.~      Eligibility:~      - Individuals between 18 and 50 years of age who have been diagnosed with developmental~     dyscalculia, or are healthy volunteers without dyscalculia.~      Design:~        -  Participants will have a screening visit and seven study visits. The screening visit~          and six of the study visits will take place consecutively over the course of 6 days,~          and the final visit will take place 3 months after the initial participation.~        -  Participants will be screened with a medical history, physical and neurological~          examination, and a brief examination to test for dyscalculia and determine the~          participant's dominant hand.~        -  Participants will be randomly assigned to one of two groups for the study. One group~          will receive tDCS during training to perform a task with numbers, and the other group~          will receive the same training with sham stimulation. Participants will not know which~          group they are in.~        -  During the study visits, participants will be trained on number tasks on 6 consecutive~          days. Before the tDCS or sham stimulation is applied at the beginning of the experiment~          and at the end of each training day, participants will perform other tasks with~          numbers. Participants will be evaluated based on the accuracy and speed with which they~          respond to the questions.~        -  At the followup visit, participants will perform the same number tasks they completed~          during the study visits. No tDCS will be performed at this visit.~   "
142009|NCT01195948|"~     Background:~      Uveitis is a serious inflammatory condition in which the body's immune system attacks parts~     of the eye, often causing vision loss. Uveitis treatments involve various drugs that~     suppress the immune system, but these medicines sometimes do not work or may cause serious~     side effects. Researchers are interested in developing new treatments for uveitis that are~     more effective and have fewer side effects.~      Optiquel® is an experimental medication being tested for its effectiveness against uveitis.~     It contains B27PD, a small protein fragment, which is similar to proteins in the parts of~     the eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce~     oral tolerance, in which the immune system is taught to recognize and not attack normal~     parts of the human body.~      Objectives:~      To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.~      Eligibility:~      Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes~     for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking~     daily prednisone or an equivalent medication.~      Design:~      Participants will be screened with a physical examination, medical history, blood and urine~     tests, and an eye exam.~      This study will last a maximum of 52 weeks. During the first 12 weeks of the study,~     participants will have a study visit every 2 weeks. For the remainder of the study,~     participants will have a study visit every 4 weeks.~      Participants will have frequent blood and urine tests, and will also have eye examinations~     and special procedures (fluorescein angiography and indocyanine green angiography) to~     evaluate the effectiveness of the treatment.~      Participants will be randomly assigned into one of three groups and will receive either one~     of two different doses of B27PD or a placebo. During the study, participants will also have~     their dose of prednisone or other steroid medication reduced.~      Participants will take one capsule three times per week on Monday, Wednesday, and Friday,~     for a total of 24 weeks. Participants may take the capsule with water, but should not~     consume any other drinks or any kind of food until at least 30 minutes have passed to~     prevent stomach upset. The capsules should be stored in the refrigerator.~   "
142010|NCT01195922|"~     Background:~      - Advanced-stage head and neck cancer (head and neck squamous cell carcinoma [HNSCC]) has~     moderately successful treatment outcomes, usually involving surgery as part of the standard~     treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor~     growth in HNSCC, and are interested in using it to treat individuals with HNSCC that has not~     been treated previously with other drugs, radiation, or surgery.~      Objectives:~      - To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head~     and neck squamous cell carcinoma.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with advanced head and neck~     squamous cell carcinoma that has not yet been treated.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and imaging studies.~        -  Approximately 1 month before scheduled surgery, participants will begin to receive~          rapamycin. Participants will take rapamycin once daily for 21 days, followed by a 7-day~          period without the drug.~        -  During the 21-day rapamycin treatment, participants will have weekly study visits to~          provide blood and urine samples and have possible tumor biopsies and imaging studies~          such as x-rays or tumor photographs. Participants will have additional study visits for~          tests 1 day and 1 week after the end of rapamycin treatment, followed by HNSCC surgery.~        -  Participants will have a final visit to provide blood samples 30 days after surgery.~        -  Participants medical records will be reviewed 1 year after surgery; however,~          participants will not need to have further study visits at this time.~   "
142011|NCT01195896|"~     The investigation is designed as a prospective, open, non-controlled clinical investigation.~   "
142012|NCT01195883|"~     A trial in which patients having open abdominal surgery are randomized to receive either~     crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators~     test the primary hypothesis that goal-directed colloid administration during elective~     abdominal surgery decreases a composite of postoperative complications within 30 days of~     surgery.~   "
142013|NCT01195870|"~     Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of~     the nerves in within the brain and the spinal cord. This disease is one of the most common~     causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there~     is an acute attack of disability as a result of an acute attack on the nervous system. There~     is usually some degree of recovery after a relapse.~      Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3~     times a week by injections under the skin. The RebiSmart device is a new injection device~     which has been developed to help patients with injecting their Rebif treatment.~      Currently, all treatments for MS are injectable and require long term patient commitment.~     Patient compliance to treatment is important for the therapy to work effectively and~     decrease the risk of relapse episodes. Using a device that makes it easy for patients to~     inject may potentially improve compliance to treatment and therefore potentially have an~     impact on the number of relapses patients experience. The RebiSmart device has been~     developed for patients to inject conveniently and in comfort. The device allows the patient~     to control certain parameters such as needle depth, needle speed, injection time etc, and~     also has extra features designed to ease the injection process, such as a dose history~     calendar and an on−screen injection guide. The aim of this study is to determine what~     percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very~     easy'' to use. The study will also determine which of the device features were most useful~     to the patients.~   "
142028|NCT01195675|"~     The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c)~     interval more than placebo~   "
142029|NCT01195662|"~     The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can~     improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled~     hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin~     Receptor Blocker (ARB).The safety of this treatment will also be studied~   "
142014|NCT01195857|"~     Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central~     nervous system (CNS) and is one of the most common causes of neurological disability in~     young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and~     is given 3 times per week by subcutaneous injection. The Rebiject II device is an~     autoinjector which allows patients easier administration of their Rebif injections.~      Prior to treatment, patients receive training on the use of the device and its maintenance.~     Currently, all treatments for MS are injectable and require long term patient commitment.~     Rebiject has been developed to improve patient convenience and comfort but does require~     multiple steps to be carried out in order for the injection to be delivered correctly.~     Reports from our local call centre and nurse advisors suggest that inaccuracies of use with~     the Rebiject device are common. By raising awareness of the level of inaccuracy and~     determining which steps patients are most likely not to complete correctly, modified~     training programs or modifications to current subject training may be put into place to~     address these issues. It is also important to demonstrate the link between poor use of the~     medication device and increased relapse rates or increased injection site reactions.~   "
142015|NCT01195844|"~     This is a 1-year study evaluating hospitalizations and the medical care for the treatment of~     diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals~     located in four Brazilian regions. A stool sample from each eligible child passing 3 or more~     loose stools or watery stools within a period of 24 hours and requiring hospitalization or~     rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus,~     using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by~     all participating hospitals.~   "
142016|NCT01195831|"~     The purpose of this study is to compare the clinical efficacy of once daily treatment for 4~     weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4~     weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.~   "
142017|NCT01195818|"~     The prevalence of Sickle Cell Associated Nephropathy (SCAN) is increasing and is a growing~     concern. Microalbuminuria is detected in the early onset of SCAN. Noteworthy, as in diabetic~     nephropathy, hyperfiltration seems to be a frequent finding, with, in our series, an overall~     incidence of 57 % and suggests a pathological links between glomerular hyperpressure and~     glomerulosclerosis which occurs several years after. Nitric oxide (NO) deficiency and the~     renin angiotensin system (RAS) are likely to be involved in the glomerular hyperpressure~     leading to hyperfiltration. Renin angiotensin antagonists are currently given for~     NEPHROPROTECTION in numerous nephropathy including SCAN despite few available reports. The~     percentage of decrease of albuminuria or the percentage of responders (ie patient~     normalizing albuminuria) has never been reported to our knowledge in SCAN patients at the~     time of hyperfiltration. The focus of our study is therefore to 1) Quantify albuminuria~     reduction after 6 months RAS treatment (primary end point); 2) Quantify glomerular~     filtration rate (GFR) reduction after 6 months of RAS treatment, and to test the hypothesis~     of a beneficial effect of RAS inhibitors on several biomarkers assessing hemolysis, NO~     inhibition and the endothelial damages (secondary end points). The ultimate aim of our study~     is to identify relevant (new) biomarkers associated to hyperfiltration and/or albuminuria~     decrease (/normalization).~   "
142018|NCT01195805|"~     The investigators wish to study the effect of retaining potassium. The participants have~     essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The~     participants will ingest tablets for 28 days before being examined. We will perform a 24~     hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we~     also examine the patient using a SphygmoCor.~   "
142019|NCT01195792|"~     The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese~     but otherwise healthy subjects with over-eating behaviours.~   "
142020|NCT01195779|"~     The purpose of this observer-blind study is to evaluate the safety and immunogenicity of~     GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35~     months of age.~   "
142021|NCT01195766|"~     The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome~     patients that have a first line chemotherapy treatment failure due to refractoriness,~     partial response or relapsed.~      In the same way, mortality, global survival and free-progression survival after O-ESHAP~     treatment and TAPH will also analyzed.~   "
142022|NCT01195753|"~     Treatment with liver cell infusion for children with urea cycle disorders (UCD).~   "
142023|NCT01195740|"~     Few empirically-based treatment models exist for adolescent suicide attempters post~     psychiatric hospitalization, despite the fact that managed care has limited the role of~     hospitalization to stabilization, rather than remission. This study will test the efficacy~     and initial outcomes of Attachment Based Family Therapy (ABFT) as an aftercare model to~     further gains made in inpatient treatment and reduce risk factors for future suicide~     attempts.~   "
142024|NCT01195727|"~     CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in~     pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban~     in pediatric subjects with a central venous catheter.~   "
142025|NCT01195714|"~     This study is a multicentric, phase II, open-label, non-randomized trial evaluating the~     efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+~     diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a~     performance status ECOG from 0 to 4.~      The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort~     of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in~     Portugal).~      Patients will be recruited over 30 months and followed at least one year after the last~     patient has been included.~      The duration of the treatment period is approximately 20 weeks.~   "
142026|NCT01195701|"~     Women who are unable to achieve orgasm compared to women who have normal orgasmic function~     may have different clitoral anatomy and different hormone levels. The investigators~     hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer~     to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe~     whether clitoral measurements differ between women with normal orgasmic function vs. those~     with anorgasmia.~   "
142027|NCT01195688|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 638683 in healthy male volunteers following oral administration of single rising doses~   "
142030|NCT01195649|"~     The primary objective of this prospective, observational, post-marketing study is to~     evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell~     Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to~     treat with Nexavar® has been made under real-life practice settings and approved~     reimbursement restriction in Taiwan. Therefore, the main objective of the study is to~     collect data on:~      Prescription pattern: to determine the factors affecting compliance and duration of~     treatment with special attention given to education status, demography, disease details,~     pre-treatment, concomitant medication and other baseline data~      Nexavar® treatment and efficacy data~      Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0~   "
142031|NCT01195636|"~     The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment~     of pain in subjects with Postherpetic Neuralgia~   "
142032|NCT01195623|"~     Duplex imaging is costly and time-consuming, but is used increasingly for preoperative~     evaluation of varicose veins. Its value in terms of the long-term results of surgery is not~     clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation~     with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings~     were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination~     led to an improvement in results. However two years is a short time, and with a longer~     follow-up other mechanisms for recurrence may become more important, e.g. neovascularization~     (new vessel formation) or progression of disease, hence the value of a detailed preoperative~     diagnosis may be diminished. The aim of this phase of the investigation is to study the~     results after 8 years, in particular what mechanisms for recurrences were most important.~   "
142033|NCT01195610|"~     The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet~     (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can~     improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and~     cardiovascular diseases.~   "
142034|NCT01195597|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling~     to quit. Secondary aims are to monitor adverse events and measure participants' perception~     and acceptance of the product.~      This pilot study will evaluate smoking reduction/abstinence effects, product preferences,~     and adverse events of a currently marketed device in Italy (Categoria electronic cigarette~     - ORIGINAL 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is~     a safe device that allows smoking reduction or abstinence in smokers.~   "
142035|NCT01195584|"~     The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008~     using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will~     present the observation of all cumulated patients operated with MAST.~      The study data will include the general health information of the subjects prior to surgery,~     information on the surgery such as OP time, blood loss, and the postoperative wound healing~     process (until discharge), which is on average the 10th postoperative day.~   "
142036|NCT01195571|"~     The purpose of this research study is to test the safety and tolerability of four new~     investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male~     volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the~     United States by the age of twenty-one. CMV does not usually cause illness in adults or~     children. However, CMV can be a cause of deafness and mental retardation in a child if a~     mother is infected during pregnancy. It also can be a serious illness in patients with~     impaired immunity (decreased ability to fight infection).~   "
142037|NCT01195558|"~     Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally~     blind individuals that results in abnormal night sleep patterns and chronic daytime~     sleepiness. This is a research protocol to develop a patient registry of subjects who may~     suffer from Non-24 and who are blind. Subjects participate in the study through a phone~     survey. This registry will be used to better understand, sleep related problems in blind~     individuals, including the investigation of a potential treatment, recruitment for future~     clinical studies, and to provide a forum for raising awareness about Non-24. The survey~     consists of questions regarding the degree of vision impairment and sleep problems that the~     subjects may be experiencing.~   "
142038|NCT01195545|"~     This is an investigator initiated pilot study to observe the short-term outcomes (a~     follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal~     Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is~     a preliminary study at the University of Washington.~      A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The~     chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40%~     within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold.~     The mesh serves as a reinforcing material during the surgical repair. It is cut to the~     appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue.~     There are many different types of meshes available on the market, and vary in the degree of~     manageability, strength, and adherence.~      Although surgical meshes work on the same principal, the variance between materials may~     affect patient outcomes. There is evidence that a biologic mesh, specifically one derived~     from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates~     compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a~     scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically,~     this would prevent the possible complications associated with synthetic mesh including mesh~     erosion into the esophagus or stricture of the esophagus.~      There are some case series showing similar short-term results between the different biologic~     meshes, but there is no direct comparative data.~   "
142039|NCT01195532|"~     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR~     tablets of gliclazide after single oral administration at the same doses to healthy~     subjects.~   "
142040|NCT01195519|"~     Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis~     and hemodialysis related issues. There is no study related to establish the predictive model~     of quality of life. This study will investigate the predictive model of quality of life in~     terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer~     the further evidence to the government to develop the effective interventions for dialysis~     patients. The optimal goal is to promote the quality care.~   "
142041|NCT01195506|"~     Vascular endothelial growth factor (VEGF)-C is recognized as a tumor lymphangiogenic factor~     based on the effects of activated VEGFR3 on lymphatic endothelial cells. VEGFR3 has been~     proposed as a specific marker for lymphatic endothelial cells. Recent studies indicated that~     VEGFR3 also expressed in a variety of human malignancies, including lung, colon rectal, or~     head and neck cancer. Moreover, VEGF-C/VEGFR3 axis was demonstrated in regulating~     angiogenesis, cell invasion, and metastasis in several solid tumors. The promotion of cell~     mobility in response to VEGF-C was required the involvement of adhesion molecule~     contactin-1. In addition to solid tumors, it has been reported that the VEGF-C/VEGFR3 axis~     is activated in subsets of leukemia patients. Until now, it has been demonstrated that~     higher endogenous VEGFC levels of acute myelogenous leukemia (AML) cells are related to~     decreased in vitro and in vivo responsiveness to chemotherapy; an effect that may result~     from inhibition of apoptosis by increasing Bcl-2/Bax ratios by the VEGF-C/VEGFR3 pathway.~     Thus, a functional VEGF-C/VEGFR3 system may exist in leukemia. However, the detail~     information concerning the role of VEGF-C/VEGFR3 in non-solid tumors is still lacking. Bone~     marrow neoangiogenesis plays a crucial pathogenic and possible prognostic role in AML. The~     VEGF-C/VEGFR3 axis has been proven in the regulation of solid tumors angiogenesis. In the~     investigators preliminary study, the investigators found VEGF-C may play a critical role in~     angiogenesis regulation of leukemic cells by upregulating cyclooxygenase-2 (COX-2).~     Furthermore, the investigators found that the upregulation of COX-2 also correlate with the~     VEGF-C-induced proliferation in leukemic cells and this phenomenon might further regulate~     the chemoresistance of VEGF-C. In this study, the investigators will investigate the extent~     of angiogenesis and chemoresistance induced by VEGF-C in leukemic cells. This study will~     provide evidences on the subject of the novel role of VEGF-C in leukemia. With progress in~     molecular biology of VEGF-C, its value as a therapeutic target is highly promising.~   "
142042|NCT01195493|"~     Chronic periodontitis is a common infectious disease characterized by progressive attachment~     loss and alveolar bone resorption eventually resulting in tooth loss. The ultimate goal of~     periodontal therapy is to prevent this endpoint. At least when a strict supportive care~     program is implemented following active therapy, subsequent tooth loss is limited to a mean~     of about 0.1 per patient per year. In contrast, three to six times as many teeth may be lost~     if the disease is left untreated.~      The objective of supportive care is to prevent disease recurrence, which is accomplished by~     strict home care and professional plaque control at regular intervals depending on the~     patient's needs. Evidently, not all patients are optimally compliant in terms of plaque~     control. Therefore, chemical aids could be administered to supplement mechanical plaque~     removal.~      Essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as~     active agents may be more appropriate to supplement daily home care. Clinical studies have~     shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control~     without relevant side effects in healthy subjects and gingivitis patients.~      Recently, significant reductions of periodontopathogens in the subgingival biofilm have been~     shown in periodontitis patients following subgingival irrigation using an essential oils~     solution. In addition, mouthrinsing on a daily basis seemed to substantially alter the~     subgingival microflora towards a less pathogenic one in gingivitis and periodontitis~     patients. Even though these are interesting findings, they should be considered exploratory~     since they relate to a small number of patients observed for only two weeks.~      The goal of the present study was to thoroughly document the clinical and microbiological~     effects of an essential oils solution used on a daily basis for 3 months as an adjunct to~     mechanical plaque control measures in a large number of chronic periodontitis patients in~     supportive care.~   "
142043|NCT01195480|"~     The aim of this clinical trial is to evaluate the feasibility, safety and biological effect~     of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific~     cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor~     ALL after allogeneic Haematopoietic Stem Cell Transplantation (HSCT).~   "
142044|NCT01195467|"~     The purpose of the study is to investigate the benefits of switching away from efavirenz~     (part of the combination pill, Atripla®) in patients with central nervous system side~     effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators~     will investigate the effect of switching to Truvada (a combination pill of tenofovir and~     emtricitabine, the other two components of Atripla) plus raltegravir.~      Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in~     number when compared to efavirenz in 2 other clinical studies, where patients were starting~     HIV treatment for the first time.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which the investigators ordinarily use to monitor your treatment) and monitor~     effectiveness, your viral load and CD4 counts, when you switch treatment from Atripla® to~     Truvada/raltegravir.~   "
142045|NCT01195454|"~     Primary Objective:~      - To assess the total metabolic effect ratios of a new insulin glargine formulation versus~     Lantus®~      Secondary Objectives:~        -  To assess the exposure ratios of a new insulin glargine formulation versus Lantus®~        -  To compare the duration of action of a new insulin glargine formulation versus Lantus®~        -  To explore the dose response and dose exposure relationship of a new insulin glargine~          formulation~        -  To assess the safety and tolerability of a new insulin glargine formulation~   "
142046|NCT01195441|"~     The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm~     for individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension~     (PIH) is suitable to identify women in high risk of developing these diseases in a Norwegian~     population.~   "
142047|NCT01195428|"~     Acute Lung Injury/Acute respiratory distress syndrome (ALI/ARDS) is a serious and frequently~     encountered entity in modern ICUs. Sepsis remains the most common cause of ALI/ARDS and~     carries the worst prognosis. The disease is characterized by an intense inflammatory~     process. This inflammation plays a major role in the development of gas exchange~     abnormalities seen in the course of the disease. Statins, primarily used as lipid-lowering~     agents, are now known to possess anti-inflammatory, antioxidant, antithrombogenic and~     vascular function-restoring actions. Therefore the investigators propose to determine if~     Simvastatin may be useful in decreasing the incidence of this deadly syndrome in critically~     ill patients.~   "
142048|NCT01195415|"~     This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating~     patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic~     cancer by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and~     gemcitabine hydrochloride may kill more tumor cells.~   "
142049|NCT01195402|"~     This randomised-controlled study is undertaken to investigate the effects of a long term low~     intensity outpatient training program on physical fitness and quality of life in moderate to~     severe COPD patients.~   "
142050|NCT01195389|"~     The purpose of this study is to determine if low level magnetic fields can help to improve~     memory in patients diagnosed with Alzheimer's dementia.~   "
142051|NCT01195376|"~     In this study, BEZ235 will be administered to adult patients with advanced solid tumors~     whose disease has progressed despite standard therapy or for whom no standard therapy~     exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235~     in Japanese patients.~   "
142052|NCT01195363|"~     To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing~     treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of~     the three thereof, in a group of patients with an index episode of a mixed state in BD.~   "
142053|NCT01195350|"~     Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic~     phase is the major measure to primary and secondary prevention, but in acute phase is not~     clear the best blood pressure level. Few studies demonstrate a U relationship between~     blood pressure and lethality; nevertheless any Brazilian study has addressed this issue.~      This is a prospective observational study on the relationship between BP and mortality in~     the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be~     analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis~     of hemorrhagic and ischemic stroke. Participants will be divided into three groups according~     to the initial PA present:~      Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic~     BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180~     mmHg entry. Multiple logistic regression analysis will be done to verify the association of~     blood pressure and lethality adjusted to confounding variables.~   "
142054|NCT01195337|"~     The goal of this study is to learn why some black and Latino men and women choose not to~     exercise very often. Researchers also want to learn more about any social and environmental~     factors that may affect the way an exercise program is followed.~   "
142055|NCT01195324|"~     The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on~     a single oral dose of warfarin.~   "
142056|NCT01195311|"~     This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360~     (study drug) is safe, well-tolerated and effective in patients with advanced malignancies.~     Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28~     days before the next group is enrolled and may begin to receive study drug. For subject~     safety, the first subject in each cohort will be administered drug for one week before the~     next two subjects in the cohort can begin drug administration. Doses will be escalated~     unless a dose-limiting toxicity (DLT) is observed in one of three subjects.~      An expanded cohort of up to 15 patients may be recruited to further explore safety at the~     'maximum tolerated dose' or at a lower, pharmacologically active, dose.~   "
142057|NCT01195298|"~     This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab~     administered as first-line treatment of previously untreated elderly patients, older than 70~     years, with metastatic or locally recurrent breast cancer.~   "
142058|NCT01195285|"~     This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to~     traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and~     cost.~   "
142059|NCT01195272|"~     This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab)~     on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in~     patients with active rheumatoid arthritis who have an inadequate response to current~     biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will~     receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as~     monotherapy or in combination with their current non-biologic DMARD. Anticipated time on~     study treatment is 52 weeks.~   "
142060|NCT01195259|"~     Observational analyses of data from population registeries have suggested that metformin may~     be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both~     contain groups of subjects randomly allocated to metformin and rosiglitazone. This~     meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to~     compare their incidence on metformin with that on rosiglitazone.~   "
142061|NCT01195246|"~     The purpose of this study is to compare the immune response to HEPLISAV™ booster injection~     with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with~     end stage renal disease (ESRD) on hemodialysis.~   "
142062|NCT01195233|"~     The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of~     radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam~     Khomeini Hospital.~   "
142063|NCT01195220|"~     Project Aware introduces a sexually transmitted infection (STI) screening model for sexually~     experienced adolescents aged 14 to 21 in a large, inner-city Emergency Department (ED) in~     the Bronx, N.Y. Project Aware will scaffold routine, rapid testing and counseling for~     Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) onto an existing, successful,~     ED-based HIV testing and counseling program, Project BRIEF. Project Aware will educate and~     motivate youth to use condoms with the aid of a theory-based, youth-friendly multimedia~     behavioral intervention proven to be effective during the investigator's K23 training.~     Through Project Aware, the investigators propose to change the paradigm of STI testing.~     Whereas a view of HIV exceptionalism has persisted in U.S. health policies on STI testing,~     the investigators propose a comprehensive approach, in which efforts to identify, treat, and~     prevent multiple STIs coalesce in one program. The research study has two phases. In the~     production phase, new STI material will be added to the multimedia intervention currently~     used for HIV education. In the evaluation phase, a randomized controlled trial (RCT) will be~     conducted to assess the effectiveness of Project Aware in identifying, treating, and~     preventing new STI infections among high-risk adolescents. The RCT is designed to test the~     incremental effectiveness of three STI prevention methods: (1) HIV testing and counseling~     (T&C), (2) HIV T&C and STI testing, and (3) HIV/STI Testing plus a point-of-service risk~     reduction video that incorporates both HIV and STI counseling and education. The study is~     powered to examine three STI prevention outcomes: (1) the number of STI infections~     identified and treated successfully at baseline; (2) the number of new STI infections over~     the 12 months following study entry, identified by (a) performing STI testing at each~     follow-up assessment; and (b) obtaining anonymized rate data on STIs reported to the New~     York City Department of Health; (3) condom use behavior. 600 youth aged 14-21 will be~     enrolled in the RCT. Youth will be approached in the ED waiting room and recruited by Public~     Health Advocates. All will complete a survey to screen for eligibility; eligible youth will~     complete the baseline measures and be randomized. The follow-up data points and measures~     will be followed at 4, 8 and 12 months (4 time points) and STI testing will be included.~   "
142064|NCT01195207|"~     This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.~   "
142065|NCT01195194|"~     The objective is to assess if low pre-transplantation donor specific T-cell reactive~     patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed~     with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.~   "
142089|NCT01194869|"~     The purpose of this study is to identify new treatment regimens with better response rates~     and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and~     sorafenib can shrink the size of your breast tumor and allow you to preserve your breast.~     Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy~     work better. Additionally, by receiving chemotherapy before surgery, we will be able to~     determine if your cancer is responsive to chemotherapy.~   "
142163|NCT01193868|"~     This phase II trial is studying how well RO4929097 works in treating patients with advanced~     non-small cell lung cancer who have recently completed treatment with front-line~     chemotherapy. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
142066|NCT01195181|"~     Hepatitis C virus (HCV) infection provokes thousands of deaths every year all over the~     world, being the major cause of progressive liver disease, primary hepatic cancer and liver~     transplantation. Today, a curative therapy is available, that can eradicate the viral~     infection and determine the regression of liver fibrosis, also in cirrhotic subjects.~      The current standard-of-care for HCV chronic infection is combination therapy with~     peginterferon (P-IFN) and ribavirin (RBV). However, this treatment is not only expensive but~     determines several side effects, that can reduce drug tolerance and hence, patient adherence~     to therapy. There are two types of available P-IFN on the market: P-IFN alfa-2a (Pegasys®,~     F.Hoffmann-La Roche) administered at a flat-dose of 180 mcg/week and P-IFN alfa-2b~     (PegIntron®, Schering-Plough) given at a weight-based dose of 50 to 150 mcg/week. Since only~     a single amino acid differentiates these types of IFN, administration strategies depend on~     their pegilation with molecules of 40 or 12kDa, respectively, that accounts for differences~     in the pharmacokinetic and pharmacodynamic drug-profile and influences probably also~     bioactivity. No comparative data are available on the benefits and costs of the licensed~     Peg-IFN plus RBV for the treatment of HCV infection in the real clinical practice, even if,~     the benefit and favourable cost-efficacy of this antiviral therapy is well established and~     of large consensus. Recently, the first randomized controlled mega-trial to compare~     antiviral therapeutic efficacy in naïve patients with HCV-genotype 1 infection during~     different regimens of P-IFN alfa-2b (at low and standard-dose) and P-IFN alfa-2a plus RBV,~     has been published, confirming a similar efficacy, of around 40%, obtained with the three~     schedules evaluated.~      In Italy, a regional program on the Surveillance and Control of HCV Infection, set up by the~     Regional Health Councillorship, has led to the development of a clinical and epidemiological~     observatory, constituted by a network of liver tertiary centres (Hepatological Cooperative~     Network of Veneto, HepCoVe). This collaborative group is connected on-line by a common~     database that, since 2003, has prospectively collected data on a cohort of more than 3000~     patients with chronic HCV infection and, among them, of 506 naïve subjects that~     consecutively underwent combination therapy with P-IFN alfa-2a or alfa-2b plus RBV.~      The aim of this study was to rationalize and improve the social regional health program on~     antiviral treatment of chronic hepatitis C by assessing the different schedules utilization~     of P-IFN plus RBV as well as the respective therapeutic effectiveness, safety and costs in~     the real clinical practice (Project A).~   "
142067|NCT01195168|"~     Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more~     insulin resistant than women without the condition and may be at greater risk of developing~     cardiovascular disease. It is not know whether it is the overweight and insulin resistant~     component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk.~     The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a~     control population matched for body mass index (BMI), and or, insulin resistance~   "
142068|NCT01195155|"~     Adipose tissue is a central organ involved in mediating metabolic health, and so the~     investigation of treatments which improve adipose tissue function is warranted. LC n-3~     polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose~     tissue gene expression in previous studies. However this has not been investigated in women~     with polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose~     tissue dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA~     supplementation on gene expression profiles of women with PCOS.~   "
142069|NCT01195142|"~     Adipose tissue is a central organ in mediating metabolic health. There is some evidence that~     women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction~     which may negatively affect their metabolic health. The aim of this study was to assess~     transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with~     a control population matched on the basis of age and body mass index (BMI). A secondary aim~     was to then relate these gene expression profiles to the biochemical environment.~   "
142070|NCT01195129|"~     The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil~     aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.~   "
142071|NCT01195116|"~     The purpose of this study is to assess the effects of dexmedetomidine while patients undergo~     treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in~     patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a~     supplemental anesthetic agent will result in better postoperative pain management.~   "
142072|NCT01195103|"~     How does Lusedra compare with current standard of care (midazolam) for minimal to moderate~     sedation for regional anesthesia blocks prior to orthopedic surgery?~   "
142073|NCT01195090|"~     This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with~     pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite~     dual therapy with metformin and a sulfonylurea.~   "
142074|NCT01195077|"~     Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and~     animal studies of HIV inhibition by algae, we propose algal consumption as one unifying~     characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in~     Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults)~     strongly suggest that differences in IV drug use and sexual behavior are insufficient to~     explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of~     the daily diet for many people living in Chad, where prevalence of HIV has remained at less~     than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges~     between 1 to 2 tablespoons (3 - 13 grams).~      HIV viral load is the main indicator of infection, however CD4 helper cell counts are most~     predictive of morbidity and mortality.We hypothesized that the consumption of algae could be~     important in diminishing the risk of HIV infection, and subsequent progression, possibly by~     enhancing the immune response.~   "
142075|NCT01195064|"~     The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary~     disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function,~     before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a~     cardiovascular surgery, by an observational physiological study.~      An interim analysis will be performed when 100 patients will be included.~   "
142076|NCT01195051|"~     This study addresses the problem of inadequate medication reconciliation as patients cross~     boundaries between inpatient and outpatient care (ambulatory care). The purpose of this~     study is to determine whether a new, computer-based application, integrated with electronic~     prescribing, improves erroneous discrepancies between pre-hospital medications and~     medications upon patients' return to ambulatory care.~   "
142077|NCT01195038|"~     The study is designed to assess the immunogenicity and safety of one booster vaccination~     with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young~     adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1~     influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).~   "
142164|NCT01193855|"~     RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This randomized phase II trial is studying how well giving dutasteride works in~     treating patients with prostate cancer.~   "
142078|NCT01195025|"~     Volume kinetics is a method mostly used, so far, to study the distribution and elimination~     of crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement~     of bleeding during surgery) is poorly studied, though. Also, a recent study showed~     unexpected volume kinetics for a crystalloid solution when it was given after a colloid~     solution. The investigators aim to study the volume kinetics of crystalloids and colloids~     and also the combination of the two in more detail. The investigators will also compare the~     invasive hemoglobin measurements with measurements from a new non-invasive tool (Radical 7,~     from Masimo Inc.) which could help to make volume kinetics more practical for everyday use.~     Finally the investigators will also study the concentrations of a few coagulation factors to~     see if they can explain the variations in coagulability that has been described in earlier~     studies of infusion solutions.~   "
142079|NCT01195012|"~     This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping~     HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The~     program targets 5-8 year old children and their parents to change the child's lifestyle~     behaviors and the associated parenting practices to improve the child's weight status. Four~     community clinics participated. Families were recruited from clinics and after informed~     consent and baseline data have been obtained, the families were randomized into one of two~     groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait~     list control group, who started the program 7 months later. Data were gathered on all the~     participating children and their parents at three time points: baseline, post the~     intervention (month 7) and post the wait list control group completing the intervention~     (month 14).~      This was a pilot study to test the feasibility of an obesity prevention plus program~     delivered in the child's primary care clinic. The primary outcome was family attendance to~     the 3 data-collection meetings with research staff and the 6 prevention plus intervention~     sessions with a trained Health Advisor.~   "
142080|NCT01194999|"~     Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by~     strenuous events such as child birth. A common purported side effect of PVS is urgency, the~     feeling of a compelling need to void with little warning. Other overactive bladder (OAB)~     adverse effects that some claim to develop post-op include further leakage (incontinence),~     frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however,~     suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be~     alleviated by said procedure. It is our aim to investigate this relationship in our clinic.~      As a prospective member of this study, you will be asked to complete five surveys. The first~     survey will be administered prior to your pubovaginal sling. This will be used to establish~     your baseline experience of OAB. Over the course of the next year, you will be asked to~     complete the four remaining surveys at regularly scheduled check-ups.~   "
142081|NCT01194986|"~     The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how~     much AZD5213 displaces radioligand from histamine receptors when given together.~   "
142082|NCT01194973|"~     The record Primary purpose is to assess the efficacy of eculizumab in adult patients with~     aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.~   "
142083|NCT01194960|"~     Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer~     vaccine before chemotherapy to enhance immune responses, thus leading to a more effective~     therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate~     the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the~     progression free survival (PFS) of subjects with HRPC.~   "
142084|NCT01194947|"~     Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct~     subsets of melanocytic nevi that retain their distinctive pattern over time.~   "
142085|NCT01194934|"~     This is the second clinical study of NOX-A12. This study intends to provide information on~     the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated~     intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of~     hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination~     with filgrastim in healthy subjects. A single center, open-label, repeated dose study design~     is selected to best address the study objectives.The results from this study will establish~     the basis for further development of NOX-A12 in lymphoma patients undergoing autologous~     hematopoietic stem cell transplantation~   "
142086|NCT01194908|"~     Patients are being asked to take part in this study because they have metastatic breast~     cancer that is triple negative (does not express estrogen receptor (ER), progesterone~     receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and~     tamoxifen are not currently treatment options for their cancer. Another option for treating~     the patient's cancer at this point is with chemotherapy. The patient should discuss this and~     other options with their doctor prior to entering this study.~      Laboratory studies have demonstrated that ER is actually present in some triple negative~     breast cancers but is silenced (does not function properly) because methyl and histone~     groups are attached to it and inactivate it. Special drugs called demethylating inhibitors~     (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these~     methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with~     agents like tamoxifen.~      The patient is being asked to join this clinical research study to find out if ER can be~     reactivated in their cancer using decitabine in combination with LBH589. If ER is~     reactivated in their cancer, we will then determine if tamoxifen can decrease the growth of~     the cancer.~   "
142087|NCT01194895|"~     The purpose of this trial is to determine whether low tidal volume during intraoperative~     one-lung ventilation could decrease the incidence rate of postoperative acute lung injury~     compared to normal tidal volume.~   "
142088|NCT01194882|"~     Primary Objective:~      To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump~     refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess~     efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml~     group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative~     phase).~      Secondary Objective:~      To assess efficacy, safety, refill accuracy evolution and device interventions during the~     open-label treatment period with Insuman To evaluate daily insulin doses To assess~     Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases~   "
142090|NCT01194856|"~     The purposes of this study are to evaluate if switching an antiretroviral medication from~     efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change:~        1. the amount of fat in HIV patients with lipoatrophy,~        2. metabolic lab values such as your lipid (fat) profile, glucose (blood sugar), and~          insulin (a hormone that regulates glucose) in HIV patients with lipoatrophy.~   "
142091|NCT01194843|"~     The purpose of the study is to evaluate the efficacy and impact on morphine consumption of~     ropivacaine administered by local per and post hepatic surgery infiltration.~      Patients will be randomized to either ropivacaine or physiological serum, with equivalent~     administration modalities in both arms.~      Patients will be followed during 4 days after the surgery. They will also come back for a~     follow-up visit one month later.~      It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.~      This is a prospective, comparative, monocentric, double-blind randomized study.~   "
142092|NCT01194830|"~     Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT~     sub-study~   "
142093|NCT01194817|"~     The purpose of this study is to compare the the Nexgen knee replacement system using~     cementless fixation with the same system using cemented fixation. At minimum 2-year~     follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and~     cemented fixation will demonstrate no differences in clinical outcome based on Oxford and~     Knee Society scores, patient-assessed visual analog pain, clinical complications,~     radiographic fixation and implant survivorship.~   "
142094|NCT01194804|"~     The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH~     patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study.~     In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be~     conducted.~   "
142095|NCT01194791|"~     Primary outcome measure:~      - Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and~     Dexamethasone.~      Secondary outcome measures:~        -  Organ response rate.~        -  Predictors of response (cardiac biomarkers, serum free light chains).~        -  Toxicity~        -  Safety (type, frequency, severity and relationship of adverse events to the study~          drug).~        -  Duration of response.~        -  Time to progression.~        -  Overall survival~   "
142096|NCT01194778|"~     Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green~     vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher~     menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known~     yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of~     essential proteins). Therefore, this study was undertaken to study effects of different~     dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.~   "
142097|NCT01194765|"~     Anxiety disorders are common pervasive conditions with serious psychosocial implications.~     Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the~     onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of~     anxiety-related arousal sensations (i.e., increased heart rate) that arises from the~     tendency to interpret these sensations catastrophically, believing that they will have~     serious physical, psychological, or social consequences (Reiss, 1991).~      Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et~     al., 2006). Unfortunately, access to effective psychological treatments is limited by a~     number of barriers such as a lack of treatment availability or qualified clinicians in an~     area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of~     a distance-based CBT program on decreasing AS among those with high AS. A distance delivery~     approach (e.g., via telephone) is one way to minimize treatment barriers and increase access~     to care while still delivering empirically supported treatment. Recent research suggests~     distance delivery is promising (Lovell et al., 2006).~      The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's~     (2008) brief CBT for AS. The program will include weekly modules on psychoeducation,~     cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with~     high AS will be recruited and randomly assigned to the treatment condition or wait-list~     control (after twelve weeks the wait-list group will receive treatment). In the treatment~     condition, participants will be assigned weekly reading and homework from the treatment~     manual. In addition, a therapist will guide them through the treatment by providing~     individualized support and feedback through weekly half-hour telephone sessions. Treatment~     outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to~     post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be~     assessed. We hypothesize that this treatment program will be effective in reducing high AS~     and anxiety symptom frequency and severity. We also expect this project to yield information~     about the utility of distance treatment delivery for mental health care.~   "
142098|NCT01194154|"~     This randomized, single-blind, proof-of-concept study will investigate the protective~     effects of early treatment with Mircera in participants with chronic kidney disease on renal~     disease progression. Participants will be randomly assigned to receive 30 microgram (mcg)~     Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of~     hemoglobin values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The~     anticipated time on study treatment is 24 months.~   "
142099|NCT01194141|"~     Barth syndrome (BTHS) is a genetic disease that results in heart failure, muscle weakness~     and exercise intolerance. Several studies in non-BTHS heart failure suggest that endurance~     exercise training is beneficial in improving exercise intolerance, heart function and~     quality of life in young men with BTHS. This study will examine the effects of Endurance~     (i.e. aerobic) exercise training on exercise tolerance, heart function, and quality of life~     in adolescents and young adults with BTHS. We hypothesize that 3 months of endurance~     training will improve exercise tolerance, heart function and quality of life in adolescents~     and young men with BTHS.~   "
142100|NCT01194128|"~     This study will assess the effects of an intervention targeting family caregivers who~     recently placed a relative in a long-term care facility because of cognitive and/or physical~     disability. In a two group randomized clinical trial we predict that caregivers assigned to~     active treatment will have lower levels of depressive symptoms, anxiety symptoms, and~     greater satisfaction with the long-term care facility when compared to individuals assigned~     to the control condition.~   "
142101|NCT01194115|"~     The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour~     course of broad spectrum antibiotics prevents wound infection complications in patients that~     are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women~     undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a~     prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of~     normal vaginal flora will decrease the rate of surgical site infection in obese patients~     that are at a greatly increased risk of postoperative infections complications.~   "
142509|NCT01189292|"~     The study is to compare the postoperative recovery, as determined by postoperative nausea~     and vomiting (PONV) after preoperative application of single-dose dexamethasone versus~     saline in patients undergoing partial or total thyroidectomy.~   "
142102|NCT01194102|"~     The purpose of this study is to evaluate whether persons with stroke participating in a~     12-week community based wellness program for persons who have had a stroke, experience~     improved mobility (6 Minute Walk Test), balance, (The Short Portable Performance Test and~     Timed Up and Go), strength (JAMAR hand grip dynamometry), level of physical activity (Rapid~     Assessment of Physical Activity), reintegration in community (Reintegration into Normal~     Living Index), self efficacy (Patient Activation Measure) and Quality of Life (Stroke~     Specific Quality of Life Scale) compared to persons who do not participate in the program.~   "
142103|NCT01194089|"~     This prospective, randomized, double-blind study will enroll nonsmoking female subjects~     undergoing laparoscopic bariatric surgery under general anesthesia. The hypothesis of this~     study is that female nonsmokers who receive nicotine via nasal spray immediately before~     waking up from anesthesia will need less pain medications 24 hours after the surgery~     compared to the subjects who receive placebo spray.~   "
142104|NCT01194076|"~     The purpose of this study is to examine how well intensive cognitive-behavioral therapy~     (CBT) delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms~     in children and adolescents. Treatment will consist of exposure and response prevention with~     an added focus on teaching parents to be exposure coaches.~   "
142105|NCT01194063|"~     Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.~   "
142106|NCT01194050|"~     This observational study will investigate the tolerability and efficacy of Tarceva~     (erlotinib) in daily clinical practice under routine conditions in patients with locally~     advanced or metastatic non small cell lung cancer. Data will be collected for approximately~     12 months.~   "
142107|NCT01194037|"~     The primary objective of this study is to evaluate the safety and tolerability of ascending~     doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this~     study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV.~     The exploratory objective of this study is to make a preliminary assessment of Hanferon™~     efficacy in combination with RBV.~   "
142108|NCT01194024|"~     The goal of this multicenter study is to develop a standardized scoring system for~     inhalation injury that can be used both to quantify and predict injury severity inhalation~     injury in adults over 18 years of age. A model will be developed based on clinical,~     radiographic, bronchoscopic, and biochemical parameters that will predict the severity of~     inhalation injury with greater than 80% predictive accuracy~   "
142109|NCT01194011|"~     Research objectives To provide people with sufficient information regarding health care and~     to improve its quality, this research endeavors to discuss the establishment of a health~     care information openness and transparency mechanism within the framework of the National~     Health Insurance system. This research also evaluates whether the transparency of health~     care quality information makes care givers provide better quality. Meanwhile, when~     appropriate information and quality index are presented to patients, patients shall have~     more knowledge about what they are dealing with, hence less misunderstanding between~     hospitals and patients would occur.~      Research Methods~        1. To revise indicators based on international trends, related literature and the need of~          people.~        2. To present 50 sets of quality indicator statistically on the website, and provide~          updated information about the first 10 sets.~        3. To analyze and explain the outcome and purposes of the indicator to the public.~        4. To estimate the possible trend for the coming year, and provide adaptive strategy.~        5. To promote the website, and hold workshops in all six regions of Taiwan.~        6. To make the website linked to the top 5 most populated official and unofficial~          websites.~        7. To respond to questions on the forum of the website daily, and maintain the system,~          update the website regularly.~        8. To complete the acceptability survey on health care institutions and people.~   "
142110|NCT01193998|"~     The purpose of this study is to evaluate a validated diagnostic prediction model in the~     appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency~     department with undifferentiated dyspnea.~   "
142111|NCT01194713|"~     Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in~     the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta).~     Recent animal studies have shown that extended wakefulness is associated with increased~     production of these Abeta proteins and that sleep leads to a marked fall in their~     production.~      Aim: The investigators aim to distinguish a similar effect of sleep disturbance on~     cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as~     an important factor in AD development.~      Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep~     deprivation night and before and after a control night with unrestricted sleep.~      Expected results: The investigators expect sleep deprivation to lead to an increase in CSF~     Abeta levels, as compared to the levels in the control night.~   "
142112|NCT01194700|"~     The purpose of this study is to determine the effect of plastic spacers and breath actuated~     spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and~     whether electrostatic charge within plastic spacers has a clinically relevant impact on the~     inhaled steroid delivery.~   "
142113|NCT01194687|"~     Background:~      - Bacteria and other micro-organisms in the intestines play important roles in immunity and~     other health conditions. As a result, these micro-organisms are likely to affect many health~     conditions, including several types of cancer. Because cancer and other diseases may affect~     the digestive system and the bacteria within it, fecal samples that are taken both before~     and after the onset of a disease may show important changes in the body and provide~     information about possible treatments. However, unlike repositories of blood and tissue~     samples, researchers do not have a repository of fecal specimens. Researchers are interested~     in determining whether standard collection procedures used for fecal occult blood testing~     can provide accurate information on micro-organisms in the intestine.~      Objectives:~      - To determine whether standard fecal occult blood testing procedures can provide accurate~     collections of fecal micro-organisms for research purposes.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  At the clinical center, participants will be provided with written and illustrated~          instructions for the collection procedures and a self-administered risk questionnaire.~          The questionnaire will assess the challenges of collecting fecal specimens and will~          collect data on major dietary restrictions (e.g., vegan, vegetarian, food allergies),~          medication use and major illnesses, knowledge of and past experience with fecal occult~          blood testing, colonoscopy and colon cancer, and the fecal collection devices.~        -  Participants will be provided with a collection bag for the sample, 16 sample~          collection tubes, and a box with frozen gel packs.~        -  On the morning of collection, participants will collect the fecal sample in the bag and~          use the collection tubes to obtain material from different parts of the stool.~        -  The tubes will be sealed and placed in the box with the gel packs, and the participant~          will hand deliver the entire box to the clinical center.~        -  Characteristics of the bacteria in the material will be measured by laboratories at the~          University of Maryland.~        -  Statistical comparisons will determine how well the procedures worked.~   "
142114|NCT01194674|"~     The objective of this study is to investigate the safety and efficacy of microplasmin as a~     treatment for uveitic macular edema.~   "
142115|NCT01194661|"~     Background:~      - Previous research has shown that certain parts of the brain are involved in voluntarily~     stopping an ongoing motor response (movement); however, it is not known whether this same~     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can~     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.~     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation~     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities~     that involve moving and suppressing movements, researchers hope to better understand how~     these brain areas might be affected in people who have had TBI.~      Objectives:~        -  To determine the parts of the brain involved in suppressing an urge to act.~        -  To determine the extent to which traumatic brain injury affecting certain parts of the~          brain is involved in problems with suppressing an urge to move and stopping movement.~      Eligibility:~      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy~     volunteers.~      Design:~        -  This research study includes a screening visit and two study visits, each of which will~          last at least 2 hours.~        -  Participants will be screened with a physical examination and medical history. Women~          who can become pregnant will have a urine pregnancy test before being allowed to~          participate in the study.~        -  At the first study visit, participants will complete one of the following experiment~          tests in an MRI scanner.~        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and~          will press a button or not press a button depending on the image shown. Participants~          will practice the experiment tasks before performing them during MRI scans.~        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and~          will press a button or not press a button depending on the image shown. Participants~          will also have TMS while at rest, and will perform the experiment tasks during the MRI~          scan.~        -  At the second study visit, participants will have an fMRI scan where they will be asked~          to do simple response tasks with a computer outside the MRI scanner.~      Background:~      - Previous research has shown that certain parts of the brain are involved in voluntarily~     stopping an ongoing motor response (movement); however, it is not known whether this same~     network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can~     significantly impair the brain's ability to voluntarily stop or inhibit certain actions.~     Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation~     (transcranial magnetic stimulation, or TMS) to investigate how people perform activities~     that involve moving and suppressing movements, researchers hope to better understand how~     these brain areas might be affected in people who have had TBI.~      Objectives:~        -  To determine the parts of the brain involved in suppressing an urge to act.~        -  To determine the extent to which traumatic brain injury affecting certain parts of the~          brain is involved in problems with suppressing an urge to move and stopping movement.~      Eligibility:~      - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy~     volunteers.~      Design:~        -  This research study includes a screening visit and two study visits, each of which will~          last at least 2 hours.~        -  Participants will be screened with a physical examination and medical history. Women~          who can become pregnant will have a urine pregnancy test before being allowed to~          participate in the study.~        -  At the first study visit, participants will complete one of the following experiment~          tests in an MRI scanner.~        -  Experiment 1: Participants will be shown arrows or images on a computer screen, and~          will press a button or not press a button depending on the image shown. Participants~          will practice the experiment tasks before performing them during MRI scans.~        -  Experiment 2: Participants will be shown arrows or images on a computer screen, and~          will press a button or not press a button depending on the image shown. Participants~          will also have TMS while at rest, and will perform the experiment tasks during the MRI~          scan.~        -  At the second study visit, participants will have an fMRI scan where they will be asked~          to do simple response tasks with a computer outside the MRI scanner.~   "
142116|NCT01194648|"~     RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by~     heating them without affecting normal tissue.~      PURPOSE: This phase II trial is studying high-intensity focused ultrasound in treating~     patients with localized prostate cancer.~   "
142117|NCT01194635|"~     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the~     laboratory may help doctors learn more about changes that occur in DNA and identify~     biomarkers related to cancer. It may also help doctors understand how patients respond to~     treatment.~      PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue~     samples from patients with unresectable stage IV squamous cell carcinoma of the head and~     neck previously treated with cetuximab, cisplatin, and radiation therapy.~   "
142118|NCT01194622|"~     The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the~     relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed~     AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE~     (i.e. FLU alone in the MP29-02 vehicle; REF).~      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when~     administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product,~     Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of~     AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess~     adverse events.~   "
142119|NCT01194609|"~     Among the immune cell therapy, autologous adoptive immune cell therapy is a method to~     transfer the immune cells derived from peripheral white blood cells and expanded and~     stimulated with various cytokines and tumor specific antigens in cancer patients. Recently,~     the low-dose radiation is known to increase the immune response in many human cancer~     patients. In a clinical trial, 70% response rate with combination of low-dose radiation and~     adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to~     investigate the feasibility of combination of low-dose radiation and autologous immune cell~     therapy in recurrent cervical cancer which is resistant to conventional palliative~     treatment.~   "
142120|NCT01194596|"~     The purpose of this study is to evaluate the effectiveness of the spirometric results~     information advice about the smoking habit the investigators designed an intervention trial~     in primary care.~      Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the~     spirometric tests on the part of the practitioner achieves a higher rate of tobacco~     reduction and abandonment than just smoking cessation advice.~      Expected results: In adult smokers, a detailed discussion of the results yielded by~     spirometry tests together with brief smoking cessation advice on the part of the primary~     care practitioner can facilitate tobacco reduction and abandonment.~   "
142121|NCT01194583|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers~     unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and~     cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The~     study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and~     adverse events of a currently marketed device in Italy (Categoria electronic cigarette -~     NO nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device~     that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal~     symptoms and cravings independently from nicotine delivery.~   "
142122|NCT01194570|"~     This randomized, parallel group, double-blind, placebo controlled study will evaluate the~     efficacy and safety of ocrelizumab in participants with primary progressive multiple~     sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or~     placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label~     Extension (OLE) treatment for participants in both groups who in the opinion of the~     investigator could benefit from further or newly initiated ocrelizumab treatment. Unless~     terminated early, all participants will continue their treatment with open-label ocrelizumab~     until the last participant who entered the OLE phase reaches 4 years of open-label~     ocrelizumab treatment.~   "
142123|NCT01194557|"~     Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor~     access to health facilities, home management of malaria (HMM) can improve the timeliness of~     treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and~     impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as~     well as in formal health facilities. Up to 80% of malaria cases are treated outside the~     formal health sector and shops are frequently visited as the first (and in some cases only)~     source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role~     of shops in home management and to ensure that drugs sold are appropriate. The current~     practice of presumptive treatment of any febrile illness as malaria (both at health~     facilities and in the context of HMM) based solely on clinical symptoms without routine~     laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT~     being a more costly regimen, it is important to be more restrictive in its administration~     and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in~     remote locations lacking electricity and qualified health staff.~      This study therefore proposes to evaluate the feasibility, acceptability, and~     cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug~     shops in an area with high malaria transmission.~   "
142124|NCT01194544|"~     Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is~     gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter~     and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is~     also responsible for maintaining an antireflux barrier. Hill et al developed a grading~     system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is~     simple, reproducible, and offers diagnostic aid in the evaluation of patients with~     suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief~     that large meals provoke considerable postprandial reflux and it results from an increase in~     the rate of transient lower esophageal sphincter relaxations. One study also revealed that~     rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study~     attempted to evaluate the relationship between dietary habit and GEFV abnormality. The~     investigators used a questionnaire regarding the dietary habit to the population undergoing~     EGD in a self-paid health examination.~   "
142125|NCT01194531|"~     Natera is recruiting patients for a research study evaluating pregnancy and implantation~     rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening~     (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.~      Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited~     to participate in a randomized study.~      The purpose of this study is to determine whether PGS- testing of embryos created during IVF~     for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and~     implantation rates in patients when compared to patients whose embryos are not tested. PGS~     will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from~     Natera.~      All subjects who qualify and enroll will receive discounted IVF medications (both TEST and~     CONTROL arms). If you become pregnant during the study, you will receive a small payment for~     providing information about your pregnancy and birth. If you are assigned to the TEST arm of~     the study you will receive free PGS.~   "
142126|NCT01194518|"~     The lifestyle consulting program through one year follow-up could effective increase the~     scores of health responsibility and nutrition according to the past three-year study.~     Behavior change is a dynamic and complex process. Using a long-term follow up approach will~     be able to understand the trajectory of behavior change. The purpose of this study is to~     explore life experience and lifestyle intervention program for patients with chronic kidney~     disease using mixed methods with a longitudinal approach. The first year of this study will~     include a qualitative study with in depth interview of the subjects who attend previous~     study in the research team and have the scores of health promoting lifestyle among the~     highest 27% and lowest 27%. The life experience will be explored. The quantitative study~     will be an experimental design. Qualified subjects will be randomly assigned to intervention~     or control group. The intervention protocol is based on trans-theoretical model. Each~     subject will be followed every six months. The second and third year of studies will~     continue to use the qualitative and quantitative approach to understand the life experience~     and meaning among patients with chronic kidney diseases. The trajectory of life experience~     and life style changes will be explored. The method may strengthen the effectiveness of~     lifestyle program and may provide comprehensive understanding of the trajectory of behavior~     changes among patient with chronic kidney disease.~   "
142127|NCT01194505|"~     Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of~     posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same~     outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks.~     More specifically under the combination of sciatic nerve block plus femoral nerve block plus~     obturator nerve block.~   "
142128|NCT01194492|"~     The purpose of this study is to determine whether the kinetics of endogenous albumin is~     altered by the generalized inflammation caused by major abdominal surgery.~   "
142129|NCT01194479|"~     Insulin treatment often causes the blood glucose levels to fall too low. The body usually~     responds to low blood glucose levels by releasing hormones which act against the insulin to~     help correct the low blood glucose levels. However, this hormone response can be altered in~     people with diabetes. Currently there are no therapeutic agents that can be used to improve~     the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine~     whether a formoterol inhaler can be used to improve and accelerate the recovery from~     hypoglycemia in patients with type 1 diabetes.~   "
142130|NCT01194466|"~     The overall goal of this study is to examine the effect of a single dose of TENS on~     mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis~     is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the~     mouth, nose, and throat) that causes significant pain, functional impairment, and diminished~     quality of life. Head and neck cancers pose specific challenges to effective pain management~     and past studies suggest the use of effective non-pharmacologic strategies such as TENS may~     be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving~     quality of life. The investigators hypothesize that a single dose of TENS will decrease pain~     and improve function and quality of life in head and neck cancer patients. This project is~     particularly innovative because it is the first known study to examine the efficacy of TENS,~     an established safe, inexpensive and easy-to-use non-pharmacologic pain management~     intervention, for treating acute oral mucositis pain. The investigators research translates~     bench (animal model) science to human subjects using an interdisciplinary approach to pain~     management. Establishing whether TENS is effective for reducing mucositis pain is a critical~     first step toward establishing an effective, non-pharmacologic pain relief intervention for~     mucositis.~   "
142131|NCT01194453|"~     A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC)~     cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient~     administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences~     based on histologic type. The investigators want to research some biomarkers that can~     predict clinical outcomes.~   "
142132|NCT01194440|"~     RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal~     symptoms in women receiving hormone therapy for breast cancer.~      PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing~     musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III~     breast cancer receiving letrozole.~   "
142134|NCT01194414|"~     This randomized, double-blind, parallel group study compares the efficacy and safety of~     subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with~     moderate to severe active rheumatoid arthritis. Participants were randomized to receive~     either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv~     every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week~     24. The double-blind period was followed by a 72-week open-label treatment with some~     switching of sc and iv administration. No placebo was administered in the open-label phase.~     Participants continued on their stable dose of disease-modifying antirheumatic drugs~     (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.~   "
142135|NCT01194401|"~     This prospective, multi-center observational study will assess the long-term efficacy and~     safety of RoActemra/Actemra in daily practice in patients with active moderate to severe~     rheumatoid arthritis who have an inadequate response or are intolerant to one or more~     disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.~     Data will be collected from patients initiated on RoActemra/Actemra treatment according to~     label by decision of the treating physician. Anticipated time for data collection from each~     patient will be 2 years.~   "
142136|NCT01194388|"~     The current observational evaluation is designed to evaluate the performance of the Axium™~     MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life~     practice.~   "
142137|NCT01194375|"~     The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo~     in treating patients with acne vulgaris.~   "
142138|NCT01194362|"~     For this study, blood and tissue samples will be collected in order to perform genetic~     testing to help researchers gather information about this disease and how and why it affects~     some patients more than others.~   "
142139|NCT01194349|"~     Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with~     infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this~     study, the investigators investigated the associations of clinical profiles and~     thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors~     of hospitalization days in patients with S. pneumoniae infection.~   "
142140|NCT01194336|"~     The primary objective of this study is to determine whether huperzine A, donepezil, and~     galantamine impact militarily relevant aspects of neurocognitive performance in humans,~     compared to placebo.~   "
142141|NCT01194323|"~     GERD is a common condition in the western world. In most cases, the diagnostic is~     established by good response to empiric proton pump inhibitor (PPI) therapy. When the~     patient symptoms are refractory to therapy, multiple invasive tests are available. The~     results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the~     physician use together to establish the diagnostic. No test however can be use alone because~     of their poor specificity and sensitivity. Recently, microscopy has been used to detect~     dilated intercellular space in between distal esophageal cells tissue; unfortunately this~     marker again failed to diagnose GERD.~      In search of more sensitive and specific markers of GERD, we propose to assess if acid~     exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area~     tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to~     determine if correlation exists between the two approaches.~   "
142142|NCT01194310|"~     Glaucoma is one of the most common reasons for blindness. Usually an elevated drain~     resistance is the reason, while aqueous humor production is normal. Medical reduction of~     intraocular pressure (IOP) is first line therapy in most cases. The gold standard of~     surgical treatment still is trabeculectomy (TE) but TE has a lot of drawbacks. In particular~     when glaucoma and cataract coexists, the investigators therefore prefer the combined~     procedure cataract extraction plus excimer laser trabeculotomy (ELT). Indication is cataract~     and a moderate elevated IOP without medical therapy or a moderate cataract and elevated IOP~     with medical therapy.~      The ELT is performed by an AIDA XeCl-Excimer Laser System (TUI-Laser AG, Germering, 1,2 mJ~     per burst, burst duration 16 ns, wave length 308 nm, spot diameter 200 µm). 10 foramina were~     made over 90 degrees of the anterior chamber angle.~        -  Trial with medical device~        -  Trial with surgical intervention~   "
142143|NCT01194297|"~     Severe influenza respiratory disease is increasingly recognized in children. Influenza~     hospitalization rates in high-risk infants, such as premature infants, are increased some~     five-fold over rates in other children. The recently-licensed live attenuated influenza~     vaccine (LAIV) promotes better immune responses than the trivalent inactivated vaccine, but~     can cause wheezing. The balance of risks and benefits for LAIV in extremely premature~     infants, who may be at increased risk for both influenza disease and vaccine side effects,~     is unknown.~      The specific aim of this project is to compare the immune response and reactions of~     trivalent, inactivated influenza vaccine (TIV) and live, attenuated, intranasal influenza~     vaccine (LAIV) in groups of former premature (PT), very (V) LBW and former full-term (FT)~     infants aged 24-35 months.~      The investigators hypothesize that the immune response in FT infants will be greater with~     LAIV than TIV, and that wheezing episodes will be no more than twice as frequent in LAIV as~     in TIV recipients.~      The study will enroll 14 former premature, VLBW infants and 14 former full-term infants.~     Children will be randomized to receive one dose either TIV or LAIV. Vaccine reactions will~     be measured. One to two teaspoons mL of blood will be drawn at 0 and 7-14 days from~     immunization, and less than one teaspoon of blood will be drawn at 28-42 days.~   "
142144|NCT01194284|"~     This study is an observational safety surveillance study designed to prospectively assess~     patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide~     within the context of prevailing standard oncology practice~   "
142145|NCT01194271|"~     The goal of this clinical research study is to learn how ipilimumab in combination with~     Lupron (leuprolide acetate) affects the body's own defense (immune) system before having~     surgery to remove prostate cancer. The safety of the drug combination will also be studied.~   "
142146|NCT01194258|"~     The purpose of the study was to compare Humalog (insulin lispro)-recombinant human~     hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the~     treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.~   "
142147|NCT01194245|"~     The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human~     hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for~     the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.~   "
142148|NCT01194232|"~     Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by~     chronic pulmonary inflammation and progressive loss of gas exchange units that eventually~     results in respiratory failure. There is strong evidence that, in CF, abnormally low~     perfusion carries a high risk of death independent from the presence of pulmonary~     hypertension. However, the evolution of pulmonary vascular disease in CF and how it might~     contribute to the rate of decline in lung function is not known. Our knowledge remains~     limited to the results of old observational studies which concluded that the major causes of~     pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and~     destruction of lung tissue. Our recent data obtained by state-of-the-art Magnetic Resonance~     Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. We demonstrate~     that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate~     measures of vascular resistance as well as in collateral blood flow begin early in the~     course of CF. Newly developed therapeutics have altered dramatically the course of patients~     suffering from pulmonary vascular disease. Through this 8 week trial, we will examine by~     Magnetic Resonance Imaging the effect of Sildenafil on pulmonary perfusion and systemic~     vascularization of the lungs in subjects with mild to moderate disease.~   "
142149|NCT01194219|"~     This study evaluated the effects of an called apremilast. Apremilast works by lowering some~     of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The~     purpose of this study was to test apremilast and compare its effects to placebo (an inactive~     substance which contains no medicine but is in the same form as the drug). This study was~     able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in~     patients with moderate to severe psoriasis.~   "
142150|NCT01194206|"~     RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body~     radiation therapy may be able to send x-rays directly to the tumor and cause less damage to~     normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may~     also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is~     studying how well stereotactic body radiation therapy works in treating patients with liver~     cancer that cannot be removed by surgery or transplant.~   "
142151|NCT01194193|"~     To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when~     given orally to patients with advanced solid malignancies and lymphomas. Two intermittent~     dosing schedules will be explored with increasing doses until a maximum tolerated dose is~     determined for each schedule.~   "
142152|NCT01194180|"~     The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design~     has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of~     BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C~     or D, will be performed on a one-to-one alternating basis. Subjects in each group will be~     challenged by BCG administered intradermally. Prior to challenge, pre-existing immunity to~     TB will be induced by vaccination with BCG, MVA85A, and both in combination (when compared~     to BCG- & MVA85A-naïve individuals). BCG quantification will be assessed by analysing the~     tissue obtained in a punch biopsy of volunteers' skin over the site of BCG 'challenge'~     vaccination. Any reduction in BCG quantification between groups will then be correlated to~     existing (and future) laboratory assays of vaccine-induced immune responses in order to~     identify potential immunological correlates of protection.~   "
142153|NCT01194167|"~     This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia~     (low platelet count). Eltrombopag is approved by the FDA for the treatment of~     thrombocytopenia (low platelet count) in adults who have had an insufficient response to~     medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the~     FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to~     platelet transfusion and so for this study is considered investigational.~   "
142154|NCT01193985|"~     This an open, uncontrolled multicenter clinical study to assess the safety and performance~     of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.~      The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be~     compared retrospectively with published studies on inguinal hernia mesh.~      The secondary objectives are to explore the performance of the surgical mesh by measuring~     the pain pre and post surgery as well as a number of relevant variables for establishing the~     performance of the mesh. Data will be compared retrospectively with previous studies on~     inguinal hernia mesh with a follow-up of at least one year.~   "
142155|NCT01193972|"~     A decision aid tool will be developed using participatory research approach. The decision~     aid will be targeted to cigarette smokers scheduled for elective surgery.~   "
142156|NCT01193959|"~     Present study is aimed at investigating potential molecular predictors of sensitivity or~     resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of~     advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be~     investigated with either immunohistochemistry, fluorescence in situ hybridization or~     genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide~     ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide~     formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat~     sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC)~     and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).~   "
142157|NCT01193946|"~     The purpose of this study is to evaluate dietary protein requirements in elderly women aged~     80 years and older using the indicator amino acid oxidation technique.~      Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated~     average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly~     women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.~   "
142158|NCT01193933|"~     1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the~          efficacy of its substitution by dexamethasone if blast count is 25% and more~        2. feasibility for adults of no interruptions protocol with 8 weeks induction and 14~          weeks consolidation followed by 2-years maintenance.~        3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total~          proposed dose 560.000 IU)~        4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL~   "
142159|NCT01193920|"~     This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at~     one dose in healthy non pregnant women and then in three different doses in healthy pregnant~     women.~   "
142165|NCT01193842|"~     This partially randomized phase I/II trial studies the side effects and the best dose of~     vorinostat when given together with combination chemotherapy and rituximab to see how well~     it works compared to combination chemotherapy alone in treating patients with human~     immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive~     B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere~     with the ability of cancer cells to grow and spread. Giving vorinostat together with~     combination chemotherapy and rituximab may kill more cancer cells.~   "
142166|NCT01193829|"~     1. To compare EGFR mutations between primary non-small cell lung cancer (NSCLC) tumours~          and corresponding CTCs isolated by a label-free microfluidic device-based system~        2. To characterize the association between clinical response in NSCLC patients treated~          with gefitinib and serial changes in CTC EGFR mutations detected by a label-free~          microfluidic device-based system~      The investigators recently developed a label-free, microfluidic device for capturing~     circulating tumour cells (CTCs) and acquired a Fluidigm Biomark digital PCR instrument for~     reliable low-level DNA quantification. The overall aim of this study is to test the~     feasibility of using these state-of-the-art devices to reliably detect clinically relevant~     EGFR mutations in CTCs.~   "
142167|NCT01193816|"~     This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming~     patients down in a situation of restlessness during mechanical ventilation weaning. This~     drug is used for several years to quieten restless patients. Its purpose is to restore~     spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical~     ventilation.~   "
142168|NCT01193803|"~     Osteoarticular infections are painful and disabling diseases that require antimicrobial~     treatment adapted to the microorganisms implicated. Microbiological cultures are currently~     regarded as the reference for identification of pathogenic bacteria. However, the~     sensitivity of these cultures is very variable and depends both on the context in which~     clinical samples are taken, and on the pathogen involved. The rate of detection varies~     according to infection type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for~     prosthetic joint infections, 50% for gonococcal arthritis and 90% for non-gonococcal~     arthritis. The aim of the study is to evaluate the diagnostic performances of~     microbiological cultures and molecular methods in case of osteoarticular infections. The~     gold standard will be established by an expert group of osteoarticular infection (composed~     by a bacteriologist, a radiologist, a surgeon, an anatomy-pathologist and a rheumatologist),~     which established the final diagnosis of infected or not infected patients.~   "
142169|NCT01193790|"~     The investigators wish to evaluate coblation channeling in the treatment of chronic~     tonsillitis.~   "
142170|NCT01193777|"~     Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000~     patients in the United States develop sepsis every year. As sepsis becomes progressively~     more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump~     oxygen to the rest of the body, which is necessary for normal cell function. This is called~     septic shock. When someone develops septic shock, it is very common for the smallest blood~     vessels in the body called the microcirculation to clog, like a highway during rush hour.~     Even with the best medical care, more than one in three patients with septic shock will die.~      The major goal of this study is to test if intravenous replacement of a naturally occurring~     nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a~     patient with sepsis becomes. In our study, some patients will receive L-carnitine and others~     will receive saline. We will measure markers determining severity of illness in both groups~     and compare them to see if L-carnitine helps patients get better faster. Based on research~     already conducted, we believe L-carnitine will improve blood flow in the microcirculation,~     delivering more oxygen to cells, and help the body get better. To test if this is true, we~     will directly look at the microcirculation under the tongue with a special magnifying camera~     that looks at red blood cells, and compare both groups.~   "
142171|NCT01193764|"~     The investigators conducted a recent pilot study and found a strong positive correlation~     between the consumption of 100% chocolate and acne exacerbation. However, this study had~     limitations including the lack of placebo and the small sample size. Although studies have~     been conducted assessing chocolate's effect on acne, no study has been done evaluating this~     effect using chocolate with 100% cocoa content in a double blind placebo controlled fashion.~     This study will analyze the difference in the number and type of acneiform lesions per~     subject at the different time points (Day 4 and Day 7) compared to baseline in order to~     increase the validity of the investigators results. In addition, the investigators will use~     unsweetened cocoa powder,12 rather than chocolate candy, which contains higher quantities of~     additive ingredients such as sugar and milk to avoid interference with the results and the~     possibility to establish or not an association between the unsweetened cocoa and an effect~     on acne.~   "
142172|NCT01193751|"~     The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and~     mortality of asphyxiated newborns.~   "
142173|NCT01193738|"~     The main objective is to evaluate an osteopathic compression of pterygopalatine node on~     sleep obstructive apnea syndrome (OSA).~   "
142174|NCT01193725|"~     This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing~     it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post~     traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma.~     The investigators will test the general hypotheses that 10 sessions of VRET or PE will~     successfully treat PTSD, therapeutically affect levels of physiological arousal, and~     significantly reduce perceptions of stigma toward seeking behavioral health services.~   "
142175|NCT01193712|"~     The purpose of this study is to determine whether left ventricular endocardial pacing~     exhibits a greater acute hemodynamic response during biventricular pacing in patients who do~     not show this response to standard cardiac resynchronization therapy.~   "
142176|NCT01193699|"~     The purpose of this study is the identification of the maximum tolerated dose (MTD) of the~     investigational medicinal product. Moreover the safety and tolerability will be assessed and~     an exploratory analysis of efficacy and biomarker modulation will be performed.~   "
142177|NCT01193686|"~     The goal of this study was to train OIF/OIF Veterans with multiple injuries to be Peer~     Visitors, i.e., Volunteers who visit more recently OIF/OEF Veterans and provide support. We~     evaluated the effectiveness of the training, and any benefits that Volunteer Peer Visitors~     and the Recipients of Peer Visitors experienced as a result of participating in Peer~     Visitation.~   "
142178|NCT01193673|"~     The primary objective of the study is to find the gene(s) responsible for causing DDH. The~     secondary objective of the study is to determine the mode of genetic transmission of DDH.~   "
142179|NCT01193660|"~     This randomized control study is aimed to determine efficacy of umbilical cord blood and~     erythropoietin combination therapy for children with cerebral palsy.~   "
142180|NCT01193647|"~     This study will begin to evaluate the heritability of rotator cuff disease, and begin~     creation of a powerful resource for future genetic studies of rotator cuff disease.~   "
142181|NCT01193634|"~     The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:~      The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding~     potential lost of capture.~      Then, the ICD devices have also the capability to be remotely interrogated through the~     remote monitoring system whose performances will be reported during the study.~      Finally the study will report the electrical and handling performances of the new left~     ventricular lead.~   "
142182|NCT01193621|"~     In the present study, the investigators will establish the clinical trial technology for~     early evaluation of drug characteristics in terms of pharmacokinetics and pharmacodynamics~     for haloperidol as a model drug, using positron emission tomography.~   "
142183|NCT01193608|"~     This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in~     patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003~     (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.~   "
142184|NCT01193595|"~     Primary Objective:~      - To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of~     ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of~     related Dose Limiting Toxicities (DLTs).~      Secondary Objectives:~        -  To assess the overall safety profile of the combination~        -  To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab~          when given in combination~        -  To evaluate preliminary evidence of anti-tumor activity~        -  To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound)~          DCE-US, measuring biomarkers~   "
142185|NCT01193582|"~     A vaccine called Prevenar is already approved for use in China for vaccination of children~     younger than 6 years old against infections caused by Streptococcus pneumoniae.~      This study is to measure the amount of antibodies (antibodies help people fight off~     diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given~     Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is~     in Chinese children.~   "
142186|NCT01193569|"~     The objective of this study is to determine the natural history of acute ischemic stroke~     from large vessel thromboembolism in the brain. The target population is a stroke cohort~     with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke~     Scale (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving~     the treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all~     enrolled patients will be followed for 90 days after the index event.~   "
142187|NCT01193556|"~     The objective of this clinical study is to evaluate the operative performance of the PEAK~     PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative~     clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).~   "
142188|NCT01193543|"~     Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of~     intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present~     study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and~     given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus~     oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.~   "
142189|NCT01193530|"~     The goal of this research study is to learn if a type of light therapy can be used to help~     patients with advanced cancer who are having difficulty sleeping to sleep better.~   "
142190|NCT01193517|"~     The goal of the Phase I portion of this study is to find the highest tolerable dose of~     azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients~     with metastatic colorectal cancer.~      The goal of the Phase II portion of this study is to learn if azacitidine, given in~     combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this~     drug combination will also be studied.~   "
142191|NCT01193504|"~     The purpose of this study is to determine if Lotemax eye drops are at least as effective as~     Pred Forte eye drops, which are the standard of care after cataract surgery.~   "
142192|NCT01193491|"~     The purpose of this study is to evaluate the safety, determine the maximum tolerated dose~     (MTD) and schedule of IPI-493 in patients with hematologic malignancies.~   "
142193|NCT01193478|"~     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics~     and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic~     genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be~     sequestered in the clinic for the initial 5 days of the study.~   "
142194|NCT01193465|"~     The effects of preserving humidity and temperature by low flow anesthesia are different in~     each other anesthesia workstation.~   "
142195|NCT01193452|"~     This phase II trial on the assumption that S-1 combined with Leucovorin may have better~     efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with~     advanced colorectal cancer.~   "
142218|NCT01193127|"~     The purpose of this study is to determine whether the use of OMS302 (the study drug) in~     individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and~     effective at maintaining an adequately dilated pupil during surgery and reducing~     post-operative symptoms of discomfort (such as eye pain and irritation).~   "
142246|NCT01192763|"~     This phase I trial is studying the side effects of RO4929097 before surgery in treating~     patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking~     some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~   "
142196|NCT01193439|"~     Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes.~     Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural~     neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The~     indication of thoracoscopy in patients with pleural effusion has been optimized. In some~     studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate~     of complications. However the investigators do not know its safety on high risk patients.~     Because many patients having suspected malignancy have bed conditions due to other health~     problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the~     investigators aimed to test the safety of medical thoracoscopy in the patients with high~     risk for complications.~   "
142197|NCT01193426|"~     Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of~     localized intra-abdominal infection, is one of the main potentially fatal complications of~     cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve~     patient survival (Garcia-Tsao, 2001).~      The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count~     equal to or greater than 250 /mm3 in the ascitic fluid (method of reference). However,~     obtaining an ascitic cell count is sometimes difficult because it can not always be~     performed in emergency especially outside the opening hours of the laboratory of~     Bacteriology. This raises the necessity of developing quick and easy alternative approaches~     of diagnosis.~      Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP.~     Nevertheless, the investigators clinical teams have shown that the sensitivity of this test~     was low in a large national multicenter prospective study involving more than a thousand~     patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended~     for the routine application of diagnosis of SBP due to its lack of sensitivity.~      Although performed on small groups of patients, several studies have reported that IL-8 or~     IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed~     by the investigators preliminary results the investigators propose to study on a broad~     recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the~     interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to~     use an ELISA method, standardized, rapid and automated, applicable in the context of~     emergency (7 days a week and 24 hours a day) as previously described in the work conducted~     to exclude the urinary tract infection (Oregioni et al., 2005).~      During the preliminary experiments conducted for this project, the investigators also found~     systematic variation of another marker, leptin. This is a protein hormone involved in the~     inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the~     study of this marker in the analysis of differential protein response between patients~     suffering or not suffering from SBP.~      The investigators therefore propose a diagnostic study, non-interventional, prospective,~     multicenter trial conducted over 2 years.~        -  The main objective is to establish the diagnostic performance (sensitivity,~          specificity, positive predictive value and negative) of IL-8 and IL-6, assayed in the~          ascites fluid by an automated ELISA in the early diagnosis of SBP.~        -  The secondary objectives are to confirm the interest of the measurement of leptin in~          the SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin~          according to different clinical features in patients (score Child-Pugh classification~          and history of SBP, ascitic fluid infection with positive bacterial culture).~   "
142198|NCT01193413|"~     Early diagnosis of secondary infection of necrotic tissue in severe acute pancreatitis is~     extremely important. The investigators evaluated whether the level of soluble TREM-1~     (sTREM-1) in fine needle aspiration (FNA) fluid from patients who suspected infection is a~     good marker of secondary infection of necrotic tissue and an indicator of the proper~     treatment between drainage and necrosectomy.~   "
142199|NCT01193400|"~     Primary outcome measure:~      Evaluate the efficacy in terms of complete responses of induction therapy and first-line~     consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or~     more. The first efficacy objective is evaluate the overall remission rate (TRG), where~     general reference (RG) is defined as a patient who achieved complete remission (CR) or~     complete remission with inadequate platelet recovery (CPR).~      Secondary outcome measures:~        -  To evaluate disease-free survival (DFS)~        -  Evaluate the overall survival (OS)~        -  To evaluate the safety and tolerability of clofarabine and duration, severity and~          relationship of adverse events (AEs) occurring during treatment~        -  To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring~          between Day 1 and Day 30 of induction cycle)~        -  The incidence, intensity (according to the latest version of the CTCAE classification),~          duration, causality, severity and type of AA~   "
142200|NCT01193387|"~     This trial is conducted in Europe. The aim of this clinical trial is to investigate if two~     identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug~     exposure to the body.~   "
142201|NCT01193374|"~     A primary care approach to obesity prevention will be developed and tested in a randomized~     trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and~     prompts for effective counseling at well visits of 4 to 10 year olds will be developed~     utilizing hand held technology( PDAs). The impact on the content and quality of clinician~     counseling will be assessed in exit survey prior to and after implementation. Among families~     interested in making a change to address nutrition or activity risk reported on the screener~     a cohort with children > BMI 85% will be recruited. They will be randomized to mailed~     tailored supports to level of readiness to change versus a single generic informational~     mailing. The hypotheses are that 1)families that receive the enhanced office visit with~     screening will be more likely to plan to make changes compared to usual care; and 2)~     families receiving the tailored post visit supports will be less likely to gain weight than~     controls after 6 months.~   "
142202|NCT01193361|"~     At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and~     efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the~     treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1~     subjects~   "
142203|NCT01193348|"~     The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients~     with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal~     impairment.~   "
142204|NCT01193335|"~     The purpose of this study is to describe the safety, tolerability, and immunogenicity of a~     2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to~     preterm infants with concomitant vaccines, compared to infants born at term.There will be a~     follow-up phase to assess the persistence of the antibody response at 24 and 36 months of~     age.~   "
142205|NCT01193296|"~     The study will assess glycemic variability and optimized glycemic control in T2DM patients~     treated with a DPP-4 inhibitor as add-on therapy to metformin.~   "
142233|NCT01192932|"~     Computed tomography (CT) studies considering bronchial dimensions in chronic obstructive~     pulmonary disease (COPD) have never considered nycthemeral variations. Airway calibre, in~     COPD patients, exhibits a nycthemeral variations with maximal values around noon and minimal~     values in the early morning, that persists under long-acting bronchodilator. Furthermore, no~     study has assessed the possible nycthemeral variations of CT scans parameters reflecting~     airway remodelling and emphysema extent in COPD patients.~      This is a prospective study whose purpose is to assess these variations and their~     relationships with pulmonary function testing (PFT) in COPD patients.~   "
142206|NCT01193283|"~     Background:~        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in~          low blood cell counts, which require frequent transfusions. Standard treatment for SAA~          involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA). This~          regimen has been shown to improve the blood counts in about two-thirds of patients.~          However, the ATG/CsA regimen has the following limitations: (a) the disease can come~          back (relapse) in about one-third of patients who improve initially; and (b) in about~          10% to 15% of cases, certain types of bone marrow cancer (such as myelodysplasia and~          leukemia) can develop (called evolution). Experience with other drugs in SAA such as~          cyclophosphamide suggests that similar response rates to ATG/CsA can be achieved with a~          lower risk of relapse and clonal evolution. However, cyclophosphamide was found to have~          significant side effects in SAA when investigated over 10 years ago due to increase~          risk of fungal infections.~        -  Better antibiotic drugs against fungus have been developed and are widely used to treat~          patients who have low white blood cell counts and are at risk of developing infections.~          In SAA patients in particular, these newer antibiotics have had a large impact in~          preventing and treating fungus infections. Researchers are revisiting the use of~          cyclophosphamide in SAA treatment, and plan to give a lower dose of CsA in combination~          with the immune-suppressing drug cyclophosphamide, as well as antibiotics to protect~          against infections, as a possible treatment for the disease.~      Objectives:~      - To determine the safety and effectiveness of the combination of cyclophosphamide and~     cyclosporine in treating severe aplastic anemia that has not been treated with~     immunosuppressive therapy.~   "
142207|NCT01193270|"~     The purpose of this pilot trial is to test the safety and efficacy of administering one dose~     of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks~     gestation and less than 1000 grams birth weight). This pilot will examine whether a single~     dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum~     α-tocopherol level in the target range of 1-3 mg/dl.~   "
142208|NCT01193257|"~     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus~     prednisone compared with placebo plus prednisone in men with metastatic,~     castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based~     therapy~   "
142209|NCT01193244|"~     This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel~     (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with~     progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)~   "
142210|NCT01193231|"~     STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for~     increasing corneal re-epithelialization, decreasing the time to zero pain in~     post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months~     post op~      CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra~     lubricant in treating post PRK pain~      OVERAL STUDY DESIGN:~      Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail,~     one eye Systane Ultra)~      Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45%~     Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye~      Duration: 6.5 months~      Controls: Systane Ultra preservative-free lubricant~      Dosage/Dose Regimen: Study medication will be administered to the randomized eye through~     post op days 1-2 BID~      Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day~     through corneal re-epithelialization, post surgery months 1, 3, and 6.~      Number of Patients: 10 (20 eyes)~      Condition/Disease: patients undergoing bilateral PRK surgery~   "
142211|NCT01193218|"~     This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in~     Japanese patients with T2DM at first treatment period. The second treatment period is~     required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese~     patients with T2DM according to the ICH E1 guideline.~   "
142212|NCT01193205|"~     The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour~     Therapy (DBT) skills training group for the treatment of chronic suicidal and non-suicidal~     self-injurious (NSSI) behaviours in individuals diagnosed with borderline personality~     disorder (BPD). Previous research has established the effectiveness of a one year~     comprehensive, combined individual and group DBT treatment. However, in practice, DBT is~     often offered in a skills only group format. This study will consist of a randomized,~     controlled trial designed to evaluate the effectiveness of DBT compared to a wait list~     control. 84 participants will be randomized to the 20-week DBT group or the wait-list and~     the following outcomes will be assessed:~        1. frequency of suicidal and NSSI behaviours~        2. symptom distress~        3. impulsivity~        4. treatment retention~        5. skill acquisition and~        6. social functioning~      Assessments will occur at pre-treatment, 10 weeks, 20 weeks and 3 months post treatment. The~     following main hypotheses will be examined: (1) Patients in the DBT skills group condition~     will have superior outcomes to patients on the treatment as usual wait list control in areas~     targeted by the treatment: frequency of suicidal and NSSI behaviours, emergency room visits,~     psychiatric hospital admissions, impulsivity, and knowledge and use of behavioral skills,~     general symptoms. The group receiving DBT will have superior outcomes at post treatment and~     these outcomes will be maintained during the three month post-treatment follow-up.~   "
142213|NCT01193192|"~     This study is a multi-site, retrospective chart review to determine the effect of Neevo® or~     NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)~     levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription~     medical food indicated for the dietary management of women under a doctor's care who face~     high risk pregnancies, older overactive bladder (OB) patients and patients unable to fully~     metabolize folic acid. Data will be collected from existing patient charts of subjects~     administered Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin~     daily.~   "
142214|NCT01193179|"~     The purpose of this study is to investigate the safety of OPC-262 administered orally in~     combination with another oral antihyperglycemic agent~   "
142215|NCT01193166|"~     The study will assess the use of paliperidone palmitate compared with oral antipsychotic~     treatment in delaying time to a protocol-defined treatment failure over 12 months, in~     patients diagnosed with schizophrenia who were recently released from an inpatient~     psychiatric hospital.~   "
142216|NCT01193153|"~     This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the~     delay of relapse of the symptoms of schizoaffective disorder. This study will also assess~     the safety and tolerability of paliperidone palmitate in patients with schizoaffective~     disorder.~   "
142217|NCT01193140|"~     To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with~     solid tumors.~   "
142234|NCT01192919|"~     Overview of treatment reality in patients with bronchial carcinoma requiring systemic~     treatment and being treated by office-based oncologists in Germany.~   "
142219|NCT01193114|"~     Aim 1. Identify specific targets and processes of intervention among homeless substance~     abusing mothers with children between the ages of 2 and 6 years from information collected~     in focus groups and assessment interviews. Translate that information for the refinement of~     the ecologically based treatment manual.~      Aim 2. Test the efficacy of the treatment in a nonrandomized pilot study and revise the~     manual based upon those findings.~      Aim 3. Test the efficacy of the experimental intervention compared to treatment as usual~     (TAU) in a randomized pilot, with the goal to improve maternal substance abuse problems,~     social stability, and mental health. It is expected that the experimental intervention will~     be associated with lower substance use and related problem behaviors than TAU.~      Aim 4. Test whether intended change processes (mediators) associated with the intervention~     produce the desired change in mother's substance use, social stability, and mental health.~     It is expected that self-efficacy will mediate substance use outcomes.~      Aim 5. Explore how length of homelessness, age and ethnicity of the mother predict treatment~     response (moderators).~      Aim 6. Explore the impact of the experimental intervention (Ecologically-Based Therapy)on~     interpersonal stress and child's mental health.~   "
142220|NCT01193101|"~     This study is a phase 2 study in patients with essential hypertension.~   "
142221|NCT01193088|"~     This project includes two projects. One is looking for new genes that cause Charcot Marie~     Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify~     the symptoms a person has.~   "
142222|NCT01193075|"~     This is an observational longitudinal study to determine the natural history and~     genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease~     (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C).~      The investigators will also be determine the capability of the newly developed CMT Pediatric~     Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform~     longitudinal measurements in patients with multiple forms of CMT over a five year window~   "
142223|NCT01193062|"~     The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal~     fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments~     following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274~     single dose administration in healthy volunteers will also be assessed as part of the~     objectives.~   "
142224|NCT01193049|"~     The purpose of this study is to evaluate the relationship between upper and lower airway~     allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the~     following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2)~     cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive~     correlation between effects of prednisone versus placebo on Th2 cytokines in sputum and~     nasal exudates.~   "
142225|NCT01193036|"~     Objectives:~      The objective of this study is to develop a valid and reliable measure of the symptom burden~     experienced by patients with cancer experiencing disease-related skin problems and to~     delineate this burden over time.~      The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module~     (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to~     measure the severity of multiple symptoms and the impact of these symptoms on daily~     functioning in patients with cancer-related skin problems. We hypothesize that the~     MDASI-Derm will be valid and reliable for measuring the severity of multiple symptoms and~     the impact of these symptoms on daily functioning in patients with cancer-related skin~     problems.~      The Secondary Aims are:~        1. to develop a detailed description of the severity and interference with daily~          activities of symptoms experienced by patients with cancer-related skin problems;~        2. to assess the impact of symptom severity on standard function and quality of life (QOL)~          measures including both quantitative (Eastern Cooperative Oncology Group [ECOG]~          Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures~          (patient interviews);~        3. to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with~          cancer-related skin problems;~        4. to identify common clusters of symptoms and symptom patterns occurring over multiple~          measurement time points in patients with cancer-related skin problems;~        5. to define the qualitative symptom experience of patients with cancer-related skin~          problems;~        6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring~          symptom severity and interference with daily activities over time in patients with~          cancer-related skin problems.~   "
142226|NCT01193023|"~     The purpose of this study is to document the prevalence and type of asynchronies incidence~     during invasive mechanical ventilation in pediatric patients breathing under pressure~     support.~      And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and~     compare these incidences with asynchronies measured in pediatric patient breathing under~     NAVA system (Neurally Adjusted Ventilatory Assist).~   "
142227|NCT01193010|"~     This study is designed as a multi-center randomized controlled trial, comparing two groups~     of patients with symptomatic extra-articular malunited distal radius fractures. One group of~     patients will undergo corrective surgery of the distal radius, with preoperative~     computer-assisted planning and virtual osteotomy, and the other group will undergo~     corrective surgery, with conventional (non-computer-assisted) preoperative planning. The~     investigators hypothesize that computer-assisted surgical planning will result in a better~     functional outcome.~   "
142228|NCT01192997|"~     There is evidence of waning immunity in individuals vaccinated against meningitis C as part~     of the UK infant immunisation schedule. The intention of this study is to contact~     participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a~     PreSchool Men C trial, in which participants were randomised to receive Meningitec,~     Menjugate or Neisvac-C). They will be invited to enrol and will be randomised to receive one~     of two quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may~     confer.~   "
142229|NCT01192984|"~     The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered~     eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell~     lymphoma. The primary objective is to assess the antitumor effect in terms of best overall~     response, while the secondary objectives are to assess the antitumor effect in terms of best~     response by disease lesion, to assess the progression-free survival and to assess the~     overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.~   "
142230|NCT01192971|"~     This phase II trial will be studying how well Apatinib working in patients with liver~     cancer.~   "
142231|NCT01192958|"~     At present influenza immunity can only be reliably confirmed by a blood test. This test is~     invasive for the patient. This study is intended to validate an oral fluid/saliva antibody~     test for the variant Swine Influenza H1N1. If such a test were available, this painless and~     non invasive test will improve direct clinical care to an individual as well as~     significantly help guide future public health management of the pandemic.~   "
142232|NCT01192945|"~     The purpose of this non-interventional study is to collect data on the efficiency and safety~     of Azacitidin in the routine application.~   "
145573|NCT01149213|"~     The investigators purpose is to follow remitted patients from their previous study using~     transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents~     relapse.~   "
142235|NCT01192906|"~     This multi-center, randomized, double blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent,~     predominant negative symptoms of schizophrenia. Patients, on stable treatment with~     antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching~     placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.~   "
142236|NCT01192893|"~     Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions~     including parturition, milk let-down reflex and social behaviour. In vitro and animals~     studies have shown growing evidence that oxytocin plays a role in bone remodeling and~     osteoporosis. The investigators have previously show in a small sample of post-menopausal~     women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum~     level is significantly decreased, independently of leptin and estradiol, that are known to~     modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the~     osteoporosis pathophysiology. The aim of the present study is to confirm the relationships~     between bone status, evaluated by bone mineral density and prevalent fragility fractures,~     body composition and oxytocin serum levels on a large population. The investigators will~     also determine if the relationship between bone mineral density and oxytocin is independent~     of estradiol and leptin in this population and evaluate the relationships between oxytocin~     serum level and co-morbidities such as cardiovascular diseases, depression and dementia.~     Theses analysis will be done on the serum already available of 1000 women of the~     international OPUS cohort. Bone mineral density, body composition analysis by Dual energy~     X-ray Absorptiometry (DXA), estradiol and clinical data are already available. The~     investigators will select women, aged from 55 to 79 y at the time of inclusion.~   "
142237|NCT01192880|"~     This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled~     study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with~     persistent, predominant negative symptoms of schizophrenia. Participants, on stable~     treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838~     or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3~     years.~   "
142238|NCT01192867|"~     This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will~     evaluate the efficacy and safety of RO4917838 in patients with persistent, predominant~     negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will~     be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks,~     followed by an optional treatment extension for up to 3 years.~   "
142239|NCT01192854|"~     Randomized, double blind parallel group, positive control, multi-center trial. Patients will~     be randomized at 1:1 ratio in group A or group B~   "
142240|NCT01192841|"~     Governmental agencies in the United Kingdom and Scotland have recently instituted guidelines~     banning physicians' white coats and wearing of long-sleeved garments to decrease hospital~     transmission of bacteria. The purpose of this study is to compare the bacterial~     contamination of physicians' white coats with that of newly laundered, standardized~     short-sleeved uniforms after an eight-hour workday and to determine the rate at which~     bacterial contamination of the uniform ensues. Our hypothesis was that the physician white~     coat would have more bacterial contamination at the end of the work day.~   "
142241|NCT01192828|"~     Cystathionine beta-synthase deficiency is an inherited disease that results in elevation of~     a substance called homocysteine (Hcy) in blood and urine. Individuals with this disorder~     have a very high risk for developing blood clots and are at risk for developing eye and bone~     abnormalities. Current treatments are generally difficult to follow and can fail.~     Development of additional therapies has been limited by lack of understanding of how the~     disease works.~      The purpose of this study is to see if oxidative stress and inflammation are involved in the~     disease process and if short-term supplementation with taurine is an effective treatment.~      Funding source: FDA-OOPD~   "
142242|NCT01192815|"~     RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more~     sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types~     of radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation~     therapy may be an effective treatment for patients with head and neck cancer.PURPOSE: This~     phase II trial is studying how well giving erlotinib hydrochloride together with radiation~     therapy works in treating patients with stage III-IV squamous cell cancer of the head and~     neck.~   "
142243|NCT01192802|"~     Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy~     in the school children population. The aim of this study is to evaluate the efficacy of the~     albendazole one versus two and three doses, in school children infected with intestinal~     helminth.~   "
142244|NCT01192789|"~     Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine~     the impact of using Lady Health Workers (LHW) of National Program for Family Planning and~     Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on~     treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm~     receive a refresher in standard pneumonia case management. LHWs in the intervention arm~     receive standard training that is enhanced to include training in the recognition of severe~     pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC),~     administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced~     pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia~     or standard case management and referral to the nearest health facility for treatment~     (control). Process indicators reflecting the LHW's ability to assess, classify and treat~     pneumonia in the intervention group and cost-effectiveness data is also being collected.~      Primary Hypothesis:~      Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia~     delivered by LHWs in the community will result in a reduction in treatment failure among~     children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with~     those referred for care by the LHW.~      Secondary Hypotheses:~        1. The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or~          need for second line treatment between day 3 and day 14], will be less in the~          intervention arm compared with the control arm.~        2. LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old~          children, and adequately recognize and refer children who present with danger signs~          during initial antimicrobial therapy.~   "
142245|NCT01192776|"~     The Optimizing Cooling trial will compare four whole-body cooling treatments for infants~     born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling~     for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to~     32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate~     whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours~     and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.~   "
145574|NCT01149200|"~     Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant~     IBS patients over a 28-day period.~   "
142247|NCT01192750|"~     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to~     cancer.~      PURPOSE: This research study is studying biomarkers in tissue samples from patients with~     recurrent and/or metastatic squamous cell cancer of the head and neck previously treated~     with cisplatin with or without cetuximab.~   "
142248|NCT01192737|"~     The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the~     mother and her child and to identify the determinants in pregnant women during pandemic~     period in three public maternities in Paris, France.~   "
142249|NCT01192724|"~     Because there is limited data about long-term efficacy and safety about short-term use of~     cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary~     artery disease after 2nd generation DES implantation, especially in biodegradable polymer~     stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to~     dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject~     with long or multivessel coronary artery disease after biolimus-eluting stent implantation.~   "
142250|NCT01192711|"~     The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus~     calculator, an information technology and a telemedicine system based on the communication~     between health care professional and patient by SMS messages.~      Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin~     glulisine associated with a telemedicine system to teach CHO counting (DID) with the same~     insulin regimen administered according to usual practice.~   "
142251|NCT01192698|"~     The main goal of this study is to prevent liver allograft infection with Hepatitis C virus~     in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that~     patients who receive ribavirin immediately before transplant and intravenous interferon alfa~     2b during the anhepatic phase(while the liver is removed)will have sustained virologic~     response post liver transplant.~   "
142252|NCT01192685|"~     Transcranial magnetic stimulation (TMS) has demonstrated efficacy as a treatment for major~     depression. No objective markers have been identified that indicate which patients are most~     likely to respond to TMS therapy. The goal of the present investigation is to determine~     whether an electroencephalographic measure called cordance or a measure of blood flow in the~     frontal brain, as measured by near infrared spectroscopy (NIRS) can serve as predictors of~     outcome with TMS therapy in depression. Subjects with depression will be treated in this~     study for 6 weeks with TMS. Frontal brain blood flow measured using NIRS will be assessed~     prior to TMS therapy, and repeatedly thereafter. EEG cordance will also be obtained~     following a similar schedule. Measures of depression and other psychiatric disorders will be~     collected prior to, during and for 2 weeks after the completion of TMS treatment. The~     correlation between these measures and the EEG and NIRS measures will then be determined to~     see if these latter measures are predictive of improvement in depression.~   "
142253|NCT01192672|"~     The purpose of this study is to test whether disease-related expressive writing is effective~     in the treatment of Irritable Bowel Syndrome (IBS).~   "
142254|NCT01192659|"~     The purpose of this study is to identify risk factors for low lymphocyte count among~     patients with type 2 diabetes who are treated with oral antidiabetic drugs.~   "
142255|NCT01192646|"~     Background~      The maternal mortality ratio in Tanzania has been persistently high for ten years with no~     signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and~     2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births~     respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric~     haemorrhage, obstructed labour, pregnancy induced hypertension, sepsis and abortion~     complications.~      Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of~     births that occur outside the health facilities 31% are attended by relatives, 19% by~     traditional births attendants (TBA) while 3% have no assistance at all. Though, the~     proportional of mothers delivering in health facilities (47%) and receiving skilled~     attendance at birth (46%) is low but more than 94 percent of women attend antenatal care~     (ANC) in health facilities at least once. This indicates that there are factors that impede~     these women delivering in the health facilities.~      Low awareness of obstetric danger signs may be one of the contributing factors for delay to~     decide to seek care when a complication occur thus contributing the first phase of delay.~     Studies in Tanzania show that most women are not aware of danger signs of obstetric~     complications during pregnancy, delivery and after delivery. A study conducted in Mtwara~     rural to assess the use and determinants of skilled attendants at delivery showed that~     proportional of women delivered with skilled care increases with increasing knowledge of~     pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger~     signs~      An increasing body of evidence supports the importance of community participation in~     maternal and infant health programs for establishing ownership, identifying problems~     effectively, achieving equity and helping to institutionalize health programs. To mount an~     effective maternal health effort aimed at reducing maternal and infant mortality, multiple~     levels of program and policies need to be in place and functioning. In addition, linkages,~     from the communities, local dispensaries and health centres to first referral hospitals that~     are adequately equipped, need to be developed and sustained~      A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women~     and their primary family caregivers and home birth attendants on critical knowledge and~     skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn~     complications and promote the adoption of health care and health-seeking behaviours at the~     individual and community levels. The aim of this strategy is to prevent maternal and~     neonatal morbidity and mortality through creating awareness on women's birth preparedness~     and access to emergency obstetric care services~      RESEARCH QUESTIONS~        1. Can HBLSS increase women empowerment and male involvement in the decisions relating to~          access of emergency obstetric and newborn cares?~        2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and~          neonatal danger signs, birth preparedness and emergency readiness in a rural community?~      Objectives~      Broad Objectives:~        1. To investigate social-cultural, community and traditional practices that impact on~          women's birth preparedness and access and utilization of emergency obstetric care~          services in rural district.~        2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery~          awareness of obstetric and neonatal danger signs, birth preparedness~      Specific Objectives~        1. To explore customs, taboos and practices including herbal remedies during pregnancy and~          labour that influence birth preparedness and utilization of emergency obstetric care~          services.~        2. To assess perception, attitude and health seeking behaviour when a complication occur.~        3. To determine the effect of HBLSS educational programme on hospital delivery, birth~          preparedness, emergency readiness and utilization of emergency obstetric care services~          among women in Rufiji district.~        4. To assess the impact of HBLSS educational programme on male awareness and involvement~          in assisting women on birth preparedness and access to emergency obstetric care~          services.~        5. To determine the cost-effectiveness of HBLSS educational programme~      Methodology~      A Cluster Randomized Trial~      28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other~     14 clusters will not receive HBLSS training.~   "
142256|NCT01192633|"~     The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and~     cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into~     this study.~   "
142257|NCT01192620|"~     The purpose of this study is to test a standardized approach for children being evaluated~     for appendicitis in the emergency department. This means that all doctors would use the same~     approach to diagnose appendicitis in children in the emergency department. This pathway uses~     two scoring systems to identify patients who are at high and low risks of appendicitis.~     These scoring systems are based on the patient's symptoms, signs the doctor finds when~     examining the patient, and their blood tests. The goal of this part of the study is to~     determine if the investigators' pathway accurately identifies patients who have~     appendicitis.~   "
142258|NCT01192607|"~     The objectives of this Phase I study is to evaluate the safety and effectiveness of the~     endoscopic endodontic equipment device for root canal assistance treatment as well as to~     evaluate the ease of use of this device, by a surgeon experienced in endodontic treatment,~     in a true clinical setting.~   "
142259|NCT01192594|"~     This nested design clinical outcome study of psychiatric case manager education on disease~     state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the~     process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis~     Recovery Model-MAPP) will test the following hypotheses:~        1. Medication non-adherence in patients with schizophrenia assigned to case managers who~          receive MAPP training will decrease from their pre-study rate and from the reported~          national average after one year enrollment compared to consumers not enrolled in the~          MAPP arm of the study.~        2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and~          Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP~          at quarterly measures.~        3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete~          the first two phases of the MAPP Recovery Model in one year.~        4. Consumers in the MAPP intervention arm will have greater symptom reductions at~          quarterly data points compared to consumers not enrolled in the MAPP intervention arm.~   "
142260|NCT01192581|"~     The aim of this study is to evaluate the effectiveness, safety and tolerability of~     consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride~     injection, Vuloven) administrated intravenously for 7 days.~   "
142261|NCT01192568|"~     This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in~     children 3 to less than 17 years old, who have overactive bladder due to a neurogenic~     condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then~     return to the clinic for a potential dose titration. At this time their dose may be adjusted~     up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the~     individual response and tolerability. The total treatment time is 14 weeks and total time on~     the study is 16 weeks.~   "
145709|NCT01147302|"~     The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1~     Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated~     Rejection (AMR).~   "
142262|NCT01192555|"~     Neuroblastoma is the second most common solid tumor seen in children, but causes~     approximately 15% of childhood cancer deaths each year. Patients with high-risk disease~     require treatment with a combination of chemotherapy, surgery, radiation, and stem cell~     transplant; however, many will have their disease come back within 3 years. Due to this high~     rate of relapse, this study is being done to investigate an experimental treatment option~     for children whose disease has returned.~      This clinical trial is for patients with neuroblastoma that has either come back after~     treatment or never went away in the first place. A series of immunizations will be~     administered using a tumor vaccine and add low-dose chemotherapy to be taken by mouth on a~     daily basis. The hope is that the vaccine will cause the immune system to recognize and kill~     more types of neuroblastoma tumors. Additionally, the immunizations will be combined with~     daily low dose chemotherapy. Daily low-dose chemotherapy, also know as metronomic~     chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using~     metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific~     type of cell that tumors use to hide from the immune system.~      The purpose of this study is to test the safety and anti-tumor effect of the tumor cell~     vaccination plus low dose, metronomic chemotherapy in treating patients with~     relapsed/refractory neuroblastoma.~   "
142263|NCT01192542|"~     The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the~     new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven~     (7) days.~   "
142264|NCT01192529|"~     The most common symptoms associated to senile dementia disease are confusion about~     schedules, hyperactivity... In this sense, these patients have frequently poor nutrition,~     resulting in malnutrition problems or malnutrition high risk.~   "
142265|NCT01192516|"~     The primary objective of this project is to examine effectiveness of a tailored pacing~     intervention on fatigue, pain, and physical function compared to general pacing intervention~     and usual care groups. A secondary objective is to evaluate the natural history of symptoms~     and physical disability over time among people with knee and hip osteoarthritis.~   "
142266|NCT01192503|"~     The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want~     to make sure rasagiline is safe to give people with RLS.~   "
142267|NCT01192490|"~     The hypothesis of this study is that topical cervical and intra-cervical lidocaine will~     decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine~     device).~      1. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases~     the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).~   "
142268|NCT01192477|"~     Increases in air pollution are associated with increases in deaths from cardiovascular~     disease, but the investigators know little about how ozone air pollution affects the~     cardiovascular system. The investigators proposed study will determine the effects of ozone~     on blood vessel and heart function that could worsen illness in people with underlying heart~     disease. This will be accomplished by studying healthy volunteers who inhale ozone in a~     controlled clinical study, and also by studying their exposure to ozone and other pollutants~     during their normal daily activities. The investigators will study volunteers who may be at~     increased risk for the effects of ozone because of genetic susceptibility. Understanding the~     effects of ozone on the heart and circulation can help establish appropriate air pollution~     standards, and provide strategies to protect the most susceptible people.~   "
142269|NCT01192464|"~     Patients have a type of lymph gland cancer called non-Hodgkin Lymphoma or Hodgkin's~     Lymphoma.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by~     germs or toxic substances. They work by binding those germs or substances, which stops them~     from growing and causing bad effects. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including tumor cells or cells~     that are infected with germs. Both antibodies and T cells have been used to treat patients~     with cancers: they both have been shown promise, but have not been strong enough to cure~     most patients. We hope that both will work better together.~      We have found from previous research that we can put a new gene into T cells that will make~     them recognize cancer cells and kill them. We now want to see if we can attach a new gene to~     T cells that will help them do a better job at recognizing and killing lymphoma cells.~      The new gene we will put in T cells makes and antibody called anti-CD30. This antibody~     sticks to lymphoma cells because of a substance on the outside of the cells called CD30.~     Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong~     enough to cure most patients.~      For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this~     way it is called a chimeric receptor. These chimeric receptor-T cells seem to kill some of~     the tumor, but they don't last very long and so their chances of fighting the cancer are~     unknown.~      We have found that T cells that are also trained to recognize the virus that causes~     infectious mononucleosis can stay in the blood stream for many years. These are called EBV~     specific Cytotoxic T Lymphocytes. By joining the anti-CD30 antibody to the EBV CTLs, we~     believe that we will also be able to make a cell that can last a long time in the body and~     recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs.~     There is also some evidence that patients whose tumors are EBV negative also benefit from~     this study treatment if their tumor expresses CD30. If we are successful, we hope that these~     new cells may be able to work longer and target and kill lymphoma cells. However, we do not~     know that yet.~   "
142270|NCT01192451|"~     The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter~     prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing~     domiciliary noninvasive positive pressure ventilation.~   "
142271|NCT01192438|"~     The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal~     therapy of biopsy confirmed low-risk prostate cancer.~   "
142272|NCT01192425|"~     Examine red and white blood cells of PNH patients with bone marrow failure syndromes.~   "
142273|NCT01192412|"~     The investigators do not know which approach to treatment of non-severe high blood pressure~     in pregnancy is better for women and babies.~      In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming~     for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for~     a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes~     without increasing the risk of problems for the mother.~   "
142274|NCT01192399|"~     The objective of this study was to assess the safety and efficacy of eculizumab in hemolytic~     PNH patients. In addition, the pharmacokinetics (PK) and pharmacodynamic (PD) response of~     eculizumab was assessed and compared to overseas studies of eculizumab treatment in~     hemolytic PNH patients.~   "
142275|NCT01192386|"~     Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal~     allergic hayfever have been shown to predict development of asthma at a six-year follow-up.~     This study is a 15-year follow-up of the same patients to verify earlier results and study~     disease development.~   "
143015|NCT01182662|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for~     the therapy of severe aplastic anemia (SAA).~   "
142276|NCT01192373|"~     The investigators wish to investigate the the short term effect of low circulating free~     fatty acids in congestive heart failure patients with type 2 diabetes.~      Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral~     muscle lipid content, improves cardiac performance and exercise capacity.~   "
142277|NCT01192360|"~     The primary objective of this study is to determine if quantitative Dynamic~     contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right~     and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping~     (PC), the current gold standard of flow volume measurements.~   "
142278|NCT01192347|"~     This is an observational study to explore how different treatment regimens affect~     continuation with treatment in the first 6 months following initiation of XAGRID into adult~     patients' essential thrombocythemia therapy.~   "
142279|NCT01192334|"~     It was well known that total knee arthroplasty could improve the previously impaired~     proprioception in degenerative osteoarthritis. Most current researches have been focused on~     the change of the proprioception. However, the evaluation of the proprioception is based on~     the surrogated end.~      Double or single limb standing balance is considered functional scale. It is very important~     view for the prevention of slipping down injury in evidence-based approaches for knee~     osteoarthritis.~      Unfortunately, few study have been performed for figuring proprioceptive change after~     surgery out.~      Considering the similarity between the proprioception and the standing balance and reported~     positive result in proprioception after total knee arthroplasty, the investigators supposed~     that total knee arthroplasty might give an influence on the recovery of single limb standing~     balance.~   "
142280|NCT01192321|"~     The objectives of this study are to assess and compare bilateral uncorrected distance visual~     acuity and distance spectacle independence post bilateral implantation of AcrySof Toric~     Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of~     eyeglass purchased and patient vision-related quality of life.~   "
142281|NCT01192308|"~     All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of~     potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of~     tamoxifen treatment.However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as~     co-medication may influence the treatment outcome of tamoxifen.~      The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg~     QD. In each woman, information will be collected on endoxifen levels, CYP2D6 status,~     adherence and use of co-medication. In women who are phenotypically poor metabolizers of~     tamoxifen, a dose increase to 40mg QD will be applied and the effect of this intervention on~     tamoxifen pharmacokinetics will be evaluated after 4 weeks.~   "
142282|NCT01192295|"~     The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl)~     controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years,~     inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid~     therapy.~   "
142283|NCT01192282|"~     This is a longitudinal observational study of women presenting to Groote Schuur Hospital~     with genital warts. The study will evaluate the socio-demographic characteristics of the~     women using a structured questionnaire. It will also document the site and extend of the~     genital warts and genotyping will be performed on the warts. HIV status will be determined~     with patient consent, treatment modalities will be documented as will the outcome of~     treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will~     be analysed as will the costs of treating women with genital warts.~   "
142284|NCT01192269|"~     Various biological materials have been investigated to determine dietary fatty acid intakes,~     such as plasma, erythrocytes, and adipose tissue. The applied techniques are invasive~     sampling methods and may have limitations in studies involving infants or young children. In~     1985 the group of McMurchie suggested buccal cheek cells as a marker for dietary fatty acid~     intake; however fatty acid profiling in cheek cells has not been widely used yet.~      In a clinical intervention trial a new method will be tested. The study will consist of two~     consecutive parts: A) a correlation study will investigate the relationship between~     established fatty acid markers (red blood cells (RBC), plasma) and the newly proposed~     markers (cheek cells) before and after intervention B) an intervention study will~     investigate the time depended implementation and steady state of docosahexaenoic acid DHA in~     plasma, RBC and cheek cells.~      The participants will receive 520 mg DHA daily over a period of 30 days. Blood and cheek~     cell samples will be collected once prior to study commencement and regularly during~     intervention.~      The proposed study aims at verifying cheek cell analysis results as a non-invasive marker~     for fatty acid profiling. This will be shown by correlation analyses of fatty acids in cheek~     cells, erythrocytes and plasma phospholipids. Furthermore, the time kinetics of DHA~     incorporation into cheek cells will clarify if cheek cell fatty acids can be considered as a~     short or long term marker.~      The new non-invasive method is expected to be extremely valuable as a non-invasive approach~     for studying the fatty acid profile in human, including infants and young children.~     Therefore, it is of great interest to validate the new method in a clinical trial.~   "
142285|NCT01192256|"~     A large project consisting of:~      a) an observational trial where smoking status is recorded on 1400 consecutive people newly~     diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon~     monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment~     complications will be recorded and compared in smokers, ex-smokers and never smokers.~   "
142286|NCT01192243|"~     The purpose of this study is to examine the efficacy and safety of gefitinib combinated with~     Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).~   "
142287|NCT01192230|"~     The purpose of this study is to examine the efficacy and safety of endostatin combined with~     Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line~     or second-line chemotherapy.~   "
142288|NCT01192217|"~     The investigators conducted a prospective randomized study to compare axillary~     minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis~     in patients with recurrent spontaneous pneumothorax operated in a single institution.~      The main objective of the study was to investigate possible differences regarding short- and~     long-term clinical outcome between the two different techniques.~   "
143016|NCT01182649|"~     Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in~     all comers PCI eligible patients~   "
142289|NCT01192204|"~     This is a multicenter placebo-controlled clinical trial to assess the effects of a topically~     applied gel on precancerous oral epithelial lesions. A total of 41 participants will be~     enrolled in this trial, and 22 of them will be enrolled at Ohio State. [The remaining 19~     participants will be enrolled at the University of North Carolina (9 participants) and the~     University of Louisville (8 participants)]. At all three institutions, half of the~     participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3~     months), while half will enter the placebo control arm. All trial participants will have a~     pretreatment (including lesional and perilesional tissue) biopsy taken before and an~     excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post~     treatment effects on each patient, patients serve as their own internal control.~     Pretreatment lesional biopsies are obtained to establish a pretreatment diagnosis and~     provide a pretreatment baseline for the experimental parameters.~   "
142290|NCT01192191|"~     The primary purpose of the study is to evaluate the safety and tolerability of fluticasone~     furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese~     patients with COPD.~   "
142291|NCT01192178|"~     Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel~     group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma~     exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316~     subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments~     using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment~     starting in April 2010. Eligible subjects will be invited to return for randomization into~     the study in August 2010. This exploratory study is being conducted to assess whether~     treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of~     exacerbation and the asthma impairment associated with viral respiratory tract infections~     during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.~   "
142292|NCT01192165|"~     The purpose of this study is to determine what dose of GSK1120212 can be given safely in~     combination with at least one other drug that is already approved to treat cancer. This~     study will test the safety of up to 6 different GSK1120212 study treatment combinations~     (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin,~     pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used~     in future trials to test whether the combination treatment is a safe and effective therapy~     for subjects with metastatic lung and/or pancreatic cancers.~   "
142293|NCT01192152|"~     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000~     mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt~     Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured~     in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in~     Evansville, Indiana) in the fed state in healthy subjects.~   "
142294|NCT01192139|"~     The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg~     metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt~     Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet~     (manufactured in Evansville, IN) in fed healthy subjects.~   "
142295|NCT01192126|"~     The objective of the study is to evaluate the product performance of visual acuity of the~     Bausch + Lomb investigational daily disposable contact lenses compared to the currently~     marketed Johnson & Johnson Acuvue Moist contact lenses.~   "
142296|NCT01192113|"~     This is an open-label, randomized, multi-center clinical trial to evaluate the safety and~     efficacy in peripheral neuropathies patients treated with Mecobalamin Injection~   "
142297|NCT01192100|"~     The purpose of this study is to assess whether the daily addition of a protein-rich~     breakfast leads to beneficial changes in appetite control, food intake regulation,and~     cognitive function in overweight & obese 'breakfast skipping' young women.~   "
142298|NCT01192087|"~     The ACCEPT (A(denoid) c(ystic) c(arcinoma), E(rbitux, and) p(article) t(herapy))-trial is a~     prospective, monocentric phase I/II feasibility trial evaluating toxicity and efficacy in~     the combined treatment of intensity-modulated radiation therapy (IMRT) and carbon ion (C12)~     boost with the epidermal growth factor receptor (EGFR) antibody cetuximab. The primary~     objective of the study is to explore the toxicity of the combined modality regimen~     consisting of heavy ion therapy / IMRT and EGFR antibody immunotherapy, by assessing the~     rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to~     NCI CTCAE V. 4. Secondary endpoints include local control, distant control, overall~     disease-free survival, overall survival~   "
142299|NCT01192074|"~     This is a data base building project on the use of pre-procedure ultrasound for the~     performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries.~     Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound~     probe, actual needle angle, success rates, patient height and weight, number of attempts~     needed to place the epidural needle or spinal needle. Currently we are looking at the~     agreement between ultrasound determined depth of the epidural space or intrathecal space~     with actual needle depth.~   "
142313|NCT01191892|"~     RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet~     known whether giving carboplatin and gemcitabine hydrochloride is more effective with or~     without vandetanib as first-line therapy in treating urinary tract cancer.~      PURPOSE: This randomized phase II trial is studying giving carboplatin together with~     gemcitabine hydrochloride and to see how well it works when given with or without vandetanib~     as first-line therapy in treating patients with locally advanced or metastatic urinary tract~     cancer.~   "
142314|NCT01191879|"~     The purpose of this study is to compare p53-induced genes activation as possible markers~     differentiating between patients presenting with acute myocardial infarction and controls.~   "
142332|NCT01191645|"~     The purpose of this study is to determine whether a dopamine receptor antagonist~     metoclopramide can counteract opioid induced effects on esophageal motility and lower~     esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist~     naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.~   "
142300|NCT01192061|"~     Evidence has accumulated that systemic and ocular mechanisms, responsible for regulating~     blood flow in the area of the optic disc, such as reduced ocular perfusion pressure,~     abnormal autoregulation and vascular dysregulation may be involved in the pathogenesis of~     normal tension glaucoma (NTG). Defective cardiovascular neuroregulation has been advocated~     as a possible one of the main systemic contributing factors in the etiology of NTG. Based on~     the results of previous studies, the hypothesis has been posed that patients with NTG have~     an impaired diurnal heart rate variability (HRV) or high activity of the sympathetic~     component of autonomic nervous system (ANS) and endothelial dysfunction. Impaired balance of~     ANS, resulting in increased demand for oxygen in the tissues and subsequent low threshold of~     hypoxia in all organs (including the eye) can be an important link in the pathogenetic~     pathway of NTG, making the optic nerve more sensitive to small and short-term changes in~     perfusion pressure and prone to damage even under a statistically normal intraocular~     pressure (IOP).~      The aim of this study is to evaluate the activity and characteristics of the following~     systems: the central ANS (through a 24-hour analysis of heart rate variability and blood~     pressure), peripheral vascular system (through the analysis of the post-occlusive hyperemia~     reaction within the distal part of left upper limb) and the local retrobulbar circulation as~     measured by color Doppler imaging (CDI) in patients with NTG and healthy volunteers. The~     correlations between all above systems, as well as between them and the structural and~     functional parameters of the optic nerve, and the retina in both groups will be also~     analyzed.~   "
142301|NCT01192048|"~     Congenital heart disease (CHD) is the most common type of birth defect but the cause for the~     majority of cardiac birth defects remains unknown. Numerous epidemiologic studies have~     demonstrated evidence that genetic factors likely play a contributory, if not causative,~     role in CHD. A few genes have been identified by us and other investigators using~     traditional genetic approaches, but these genes only account for a small portion of the~     non-syndromic CHDs. Therefore, we are now utilizing whole exome sequencing (WES), with the~     addition of more traditional genetic techniques such as chromosomal microarray or~     traditional linkage analysis, to identify genetic causes of familial and isolated CHD. With~     WES we are able to sequence all of the genes of an individual and apply different data~     analysis techniques based on whether we are analyzing a multiplex family or a cohort of~     trios (mother, father and child with CHD) with a specific isolated CHD. Therefore, WES is a~     robust method for identification of novel genetic causes of CHD which will have important~     diagnostic and therapeutic consequences for these children.~   "
142302|NCT01192035|"~     BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human~     immunodeficiency virus (HIV) treatment. The most important types of drugs are called~     nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase~     inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as~     increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development~     of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but~     many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for~     development of resistance in case of treatment interruptions. PIs might therefore be a~     better option in an African setting with low adherence.~      AIM: To evaluate two different treatment regimens in HIV-1 infected patients:~      A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir)~     based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be~     superior to treatment with a NNRTI due to less development of resistance.~      METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West~     African Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+~     cell count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health~     Organization (WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs~     (lamivudine and either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or~     Treatment B: 2 NRTIs (same as in treatment A) and 1 PI (ritonavir-boosted lopinavir).~     Primary outcome: Viral load suppression <400 copies/ml 12 months after enrolment.~      PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the~     guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more~     women infected in Africa and difficulties ensuring good adherence mean that results obtained~     from Caucasian patients are not directly transferrable to African patients. The results of~     this study will hopefully help guiding the treatment of HIV in Africa in the future. The~     investigators believe the HIV infected people in West Africa deserve the same evidence-based~     medicine as in developed countries.~   "
142303|NCT01192022|"~     The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection~     surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.~     Hemostatic efficacy will be evaluated intraoperatively after application of randomized~     treatment.~   "
142304|NCT01192009|"~     Leucine supplementation is widely known for promoting strong influence on skeletal muscle~     remodeling. This study aims to evaluate the effect of leucine supplementation on~     disuse-induced skeletal muscle atrophy.~   "
142305|NCT01191996|"~     The purpose of the study is to determine the safety and tolerability, dose-limiting~     toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously~     administered MIS416 weekly in patients with chronic progressive multiple sclerosis.~   "
142306|NCT01191983|"~     This single arm, open label study will assess the efficacy, safety and tolerability of~     Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of renal anemia in~     patients with chronic kidney disease secondary to diabetes. Patients who are not on dialysis~     and not currently treated with erythropoiesis stimulating agents will receive Mircera~     subcutaneously every 4 weeks. The starting dose of 1.2 mcg/kg Mircera will be adjusted~     according to haemoglobin levels. Anticipated time on study treatment is 28 weeks.~   "
142315|NCT01191866|"~     Primary Objective is to evaluate the influence of psychosocial interventions in the~     treatment of children and adolescents with type 1 diabetes mellitus by measuring the~     connection between these interventions to quality of life and to metabolic control.~     Secondary Objective is to provide an opportunity, through quality of life (QOL)~     questionnaires, for enhanced communication between the patient, family and diabetes care~     team and also an opportunity to resolve negative issues.~   "
142333|NCT01191632|"~     The efficiency of T cell based immunotherapies is affected by the insufficient migration and~     activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical~     trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell~     connected anti tumor immune response in colorectal liver metastases.~      The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell~     activity in situ, the number of regulatory T cells and the frequency of tumor reactive T~     cells in the blood and bone marrow will be examined.~   "
142376|NCT01191060|"~     Objective of this study is to determine if, in the era of novel drugs, high dose therapy~     (HDT) is still necessary in the initial management of multiple myeloma in younger patients.~     HDT as compared to conventional dose treatment would be considered superior if it~     significantly prolongs Progression-free survival (by at least 9 months).~   "
142307|NCT01191970|"~     Presently, the literature addressing the relationship between epidural analgesia and~     likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals,~     administered prior to vaginal delivery of a full-term, healthy neonate, significantly~     decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum.~     One proposed mechanism is that analgesics, by decreasing maternal pain during labor,~     decrease maternal endorphin production and result in the transmission of lower endorphin~     levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the~     neonate less likely to suckle optimally. Other studies have found that epidural analgesia~     does not significantly decrease lactation success when used during the vaginal delivery of a~     full-term, healthy neonate.~      Although most studies to date have compared the breast-feeding success of epidural~     recipients and non-recipients at various points postpartum, they do not specifically note~     whether deficient feeding behaviors on the part of the infant contribute to failed~     breast-feeding. The present study uses the LATCH assessment tool to score the infant's~     ability to latch onto the breast and the presence of audible swallowing, as well as the~     mother's level of physical comfort with breast feeding, whether she can successfully~     position the infant for feeding on her own, and whether her nipples are inverted, everted,~     or flat. Thus, the LATCH assessment enables the separation of multiple factors that may~     contribute to breast-feeding failure. A multivariate regression analysis will determine how~     strongly the probability of breast-feeding at hospital discharge correlates with epidural~     duration, LATCH scores, and beta-endorphin concentrations in colostrum.~   "
142308|NCT01191957|"~     The purpose of this prospective phase III, open-label, randomized multicenter study is to~     evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR)~     undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity~     conditioning regimen (I.V. BuFlu) as compared to the conventional I.V.~      BuCy2 program will experience:~        1. A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells~          Transplant (HSCT)~        2. A similar anti-leukemic activity and a similar or better safety profile, in terms of:~             -  Early and/or late graft rejection~             -  Hematopoietic and immunologic recovery~             -  Chimerism~             -  Toxicity and incidence of Veno-occlusive Disease (VOD)~             -  Acute (aGvHD) and chronic graft-versus-host disease (cGvHD)~             -  Cumulative incidence of TRM at +100 days and 2 years after transplant~             -  Cumulative incidence of relapse by 1 and 2 years after transplant~             -  Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant~   "
142309|NCT01191944|"~     The objective of this trial is to evaluate non-inferiority of pramipexole Extended release~     to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's~     Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with~     Levodopa .~   "
142310|NCT01191931|"~     Study design:~      -The study will be a phase I like study to assess the extent to which prostate HistoScanning~     (PHS, the index test) can identify and characterize foci of prostate cancer when compared to~     histological samples harvested during radical prostatectomy (the reference test). The study~     will comprise 3 steps: first, defining the most suitable method for matching the TRUS~     (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms~     (training set); third, verification of the PHS performances (test set).~      Study objectives:~        -  Primary Objective:~             -  To evaluate the extent to which PHS can discriminate between malignant lesions of~               the prostate versus non-malignant tissue in 3D RF TRUS data using radical~               prostatectomy histological step sectioning as the reference test.~        -  Secondary Objectives:~             -  To adapt and refine PHS tissue characterisation algorithms using RF data that were~               previously developed using grey-level data as input.~             -  To assess the accuracy of PHS in predicting the volume of prostate cancers~               determined by histology.~             -  To assess the ability of PHS to rule in or rule out the presence of cancer > or =~               0.5 cc and of > or = 0.2 cc as determined by histology.~             -  To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3~               or less in tumours > or = 0.5 cc and > or = 0.2 cc.~             -  To assess the ability of PHS to correctly risk stratify patients.~   "
142311|NCT01191918|"~     There is a high rate of partial response to standard thymoleptic medication. In this study~     the investigators want to evaluate the safety and efficacy of donepezil as adjunctive~     treatment to mood stabilizers in bipolar disorder with acute mania. The investigators~     hypotheses were that there would be greater mean reduction in manic symptoms with donepezil~     augmentation of lithium compared with placebo.~   "
142312|NCT01191905|"~     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is~     known to be an independent risk factor for mortality. Among the various etiologies of AKI,~     sepsis or septic shock is the most frequent contributing factor especially in an intensive~     care unit setting. Also, the mortality of septic AKI in these patients still remains~     extremely high despite recent marked therapeutic advance.~      Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia~     and volume control, it has become the modality of choice in critically ill patients with~     AKI. In addition, CRRT can theoretically provide immunohomeostasis through the convective~     and adsorptive removal of various immune mediators. Although the pathophysiology of septic~     AKI remains elusive, it has become increasingly recognized that many pro- and~     anti-inflammatory mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in~     this process. Therefore, it has been speculated that the reduction of cytokines by~     increasing CRRT dose in patients with septic AKI may reduce mortality risk. Even though~     recent two large scale randomized controlled trials, ATN and RENAL study, have failed to~     show the difference in survival rate between the clearance of 20~25 ml/kg/hr and 35~40~     ml/kg/hr, none of these studies were designed to elucidate the survival benefit of high~     intensity CRRT in patients with septic AKI. Moreover, the optimal target CRRT dose in these~     patients is not well established and may be even higher than 35~40 ml/kg/hr in terms of~     septic AKI. Indeed, recent several uncontrolled trial have shown the survival benefit of~     high intensity CRRT in these patients.~      To further explore the effects of high dose CRRT on survival of critically ill patients with~     septic AKI, the investigators will conduct a multicenter prospective randomized controlled~     open-label trial which compares the difference in survival rate between 1:1 balanced~     pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The~     primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day~     survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital~     mortality, duration of CRRT and renal replacement therapy, duration of mechanical~     ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA~     and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which~     aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least~     109 subjects (a total of 218) would be required for each group if type I error rate is 5%~     and type II error is 20% given 25% of drop-out rate during the study period. Block~     randomization will be used by means of a dedicated website.~      There are still conflicting data on the optimal target dose of CRRT in patients with septic~     AKI. Our study will address this issue to answer the unresolved question on the effect of~     high dose CRRT.~   "
142759|NCT01186042|"~     The purpose of this study is to find the best tests to use to investigate the differences~     between older and younger people with HIV disease. Test to be included will measures of~     memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.~   "
142316|NCT01191853|"~     Background:~      - Seasonal influenza is a major health problem whose impact is typically reduced by~     vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the~     potential to cause devastating illness and even death in the coming months. Currently, there~     are limited data on the cellular and molecular immune responses in adult recipients of~     either the seasonal or the H1N1 influenza vaccines.~      Objectives:~      - To obtain blood and nasal wash samples and perform laboratory studies to characterize the~     immune response in healthy adult volunteers at baseline and after immunization with the~     seasonal or H1N1 influenza vaccines.~      Eligibility:~      - Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy~     by a brief medical history and physical examination and routine blood testing.~      Design:~        -  Before the start of the influenza season, volunteers will receive either the seasonal~          influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is~          available at the start of the season, volunteers will receive both the seasonal vaccine~          and the H1N1 vaccine.~        -  Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours~          prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before~          vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination.~        -  Two to four nasal washings will be collected by a nurse before volunteers receive the~          vaccination(s) and 28 days after the vaccination.~        -  Prevaccine and postvaccine blood and nasal wash samples will be compared to determine~          volunteers immune responses.~        -  Research samples will be stored indefinitely and will be used strictly for laboratory~          experiments.~   "
142317|NCT01191840|"~     The purpose of this study is to accurately determine the length of appropriate drug~     treatment for staphylococcal blood stream infection. The study seeks to address important~     information about the management of staphylococcal blood stream infections.~   "
142318|NCT01191827|"~     This study aims to determine how clozapine treatment improves neuronal measures of sensory~     gating in subjects with schizophrenia.~   "
142319|NCT01191814|"~     Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr~     plastic stents. When compared to plastic stents, randomized trials have shown longer patency~     and fewer stent-related complications for CSEMS. The investigators hypothesize that~     placement of CSEMS would be a better treatment option for preoperative biliary decompression~     in patients with pancreatic cancer.~   "
142320|NCT01191801|"~     This study will compare the overall survival (OS) between treatment groups of patients~     treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.~   "
142321|NCT01191788|"~     The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for~     depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is~     effective and cost effective in treating depression. If so, it could substantially increase~     access to appropriate mental health care. 360 clients with Beck Depression Inventory-II~     scores > 17 who are being treated in a single public sector AOD treatment organization will~     receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care~     AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD~     counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators~     will collect data on the service-level costs and health effects associated with UC and CBT,~     and will calculate the incremental cost per unit of depression and AOD improvement, compared~     to UC.~   "
142322|NCT01191775|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The~     purpose of this research study is to evaluate the safety of the investigational drug PNT2258~     in patients with advance tumors and see how it acts in the body.~   "
142323|NCT01191762|"~     The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium~     reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain~     normocalcemia in chronic kidney disease. This study will examine the hypothesis with~     measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the~     intestinal phosphate binder sevelamer carbonate will be employed to examine whether~     reductions in phosphate influx alter distal nephron phosphate concentration and the [PTH]~     required for calcium reabsorption in the expected manner.~   "
142324|NCT01191749|"~     The goal of this clinical research study is to determine the effectiveness of alemtuzumab in~     patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The~     safety of alemtuzumab will also be studied.~   "
142325|NCT01191736|"~     Bystander CPR improves survival from Out of Hospital Cardiac Arrest. This study examines the~     efficacy of ultra-brief video training for Hands-Only CPR. Subjects were randomized to one~     of four training conditions, then assessed for CPR skills retention.~   "
142326|NCT01191723|"~     Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered~     by Oral Inhalation) with Moxifloxacin and Placebo.~   "
142327|NCT01191710|"~     The aim is to explore whether the incidence of progesterone rise in the late follicular~     phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this~     has an impact on the probability of pregnancy achievement.~   "
142328|NCT01191697|"~     The purpose of this study is to determine the safety and effectiveness of a combination of~     chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab.~     Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells.~     Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer~     tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen~     and nutrients that are needed for tumor growth are decreased. The chemotherapy used in this~     trial is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.~   "
142329|NCT01191684|"~     RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective~     immune response to kill tumor cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in~     treating patients with colorectal, stomach, or pancreatic cancer.~   "
142330|NCT01191671|"~     The first years of life are considered essential to child development, as there is greater~     brain growth and formation of more neural connections. Therefore, the stimulation of~     children in various fields of development becomes relevant to the acquisition of knowledge~     and skills.~   "
142331|NCT01191658|"~     The circumference of a person's neck is a useful predictor of difficulty of insertion of a~     breathing tube.~   "
142334|NCT01191619|"~     The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective~     airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and~     larger cuff to improve sealing and a drain tube to permit venting of the stomach. However,~     the larger cuff is more difficult to save space for insertion in the mouth and is more~     likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a~     cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb~     PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using~     digital manipulation or with an introducer, but these techniques have lower success rates~     compared to those of LMA insertion.~      McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is~     used to secure the operating field by pressing tongue during tonsillectomy. The~     investigators hypothesized that McIvor blade would provide more space in the mouth for PLMA~     insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to~     the pharyngeal wall. The investigators compared the success rate and the incidence of~     complications of the digital technique with those of McIvor blade-guided insertion by~     unskilled anesthesia residents.~   "
142335|NCT01191606|"~     The aim of this study is to determine the effects of pressure controlled ventilation during~     protective one lung ventilation on blood gases, airway pressures and hemodynamic variables~     compared with volume controlled ventilation.~   "
142336|NCT01191593|"~     The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at~     reducing pain and morphine consumption after revision knee arthroplasty.~   "
142337|NCT01191580|"~     The investigators propose a randomized clinical trial to compare the efficacy of~     Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive~     Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality~     of life among patients with breast cancer and major depressive disorder (MDD).~   "
142338|NCT01191567|"~     Wounds have long been a source of suffering for unfortunate victims and in recent years new~     complementary methods have been developed in areas where traditional wound treatment has~     been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC],~     is a relatively new method of treatment and knowledge about its effect on patients is~     limited.~      Earlier studies haven't been able to answer the question about which groups of patients that~     are in most favour of the treatment and what impact the treatment has on the patient's~     quality of life.~      It is important with further research since an effective and mild wound treatment can~     decrease suffering and increase quality of life for the patient. Wound treatment that does~     not lead to an achieved treatment goal can lead to a risk for the patient and should be~     avoided.~      The project consists of 4 part studies: Study 1 and 2 are chart review studies of a~     consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period.~     The patients are described on the basis of medical, surgical and demographical factors.~     Outcome is treatment results and risk factors for a treatment failure.~      Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment~     with VAC provides a faster and more effective healing of acute and postoperative wounds, and~     in what way the treatment affect the quality of life and pain of the patients, compared to~     conventional treatment.~   "
142339|NCT01191554|"~     Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic~     acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and~     transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently~     multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has~     shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no~     randomized study focus on TA in primary valve surgery. The aim of this prospective,~     double-blinded, randomized trial is to compare two dosing regimens of TA during primary~     valve surgery on perioperative blood loss and allogeneic blood transfusion.~   "
142340|NCT01191541|"~     Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low~     relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining~     ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding~     Ara-C in the chemotherapy of APL reduced treatment toxicity without increasing relapses.~     While the relapse rate for the children with white blood cell(WBC) counts greater than~     10×109/L at presentation were higher than those WBC counts less than 10×109/L (31% and~     3.5%,respectively) in the LPA96 and 99 trials. A recent adult randomized trial show that~     avoiding Ara-C leads to an increased risk of relapse in the APL patients with WBC counts~     less than 10×109/L. The role of the Ara-C remains controversial. And there are very limited~     data reported on children with APL so far.~   "
142341|NCT01191528|"~     To compare two ways to test breathing after surgery in acute care setting. One method tests~     oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is~     breathed out.~   "
142342|NCT01191515|"~     The purpose of this study is to evaluate the near and intermediate visual outcomes of~     patients who have undergone routine cataract surgery (removal of cloudy crystalline lens)~     with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a~     plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at~     least one eye.~   "
142343|NCT01191502|"~     The purpose of this study is to evaluate visual acuity in different lighting conditions~     (daylight and night time) and distances (distance, near and intermediate), and the~     independence of glasses, in patients who have had binocular implantation of the Tecnis~     Multifocal IOL or the Crystalens™ HD Accommodating IOL.~   "
142344|NCT01191489|"~     The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the~     reintubation rate. Post-extubation respiratory failure risk will be stratified (as the~     randomization). In high risk patients high flow conditioned oxygen therapy will be compared~     with with not conditioned non-invasive mechanical ventilation. In low risk patients~     comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.~   "
142345|NCT01191476|"~     This study is being performed to compare the cost of anesthetic techniques with sevoflurane~     (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI])~     versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing~     elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.~   "
142346|NCT01191463|"~     Iron deficiency is estimated to affect about one fifth of the world's population, and women~     and children are among the most severely affected. Evidence is mounting that iron deficiency~     anemia adversely affects brain development with measurable effects on children's behavior,~     motor development and cognition. In Hisar district of Haryana state, north- India, 58% of~     school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been~     found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms~     in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third~     most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron~     and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron~     absorption in humans which can counteract the inhibitory effect of phytic acid and~     polyphenols. Guava is a popular and easily available fruit for this community having 200-~     300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age~     children (6-10 years) in Haryana state of India, to determine the efficacy of local~     vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.~      Objective: To assess the effect of mungbean based test meal on iron status (as body iron~     stores, defined and calculated by the ratio of serum ferritin and serum transferrin~     receptor) of school age children (6-10 years) with and without the consumption of guava, a~     vitamin C rich fruit, in a school feeding program for seven months.~      Study population: Three hundred school children aged between 6-10 years will be recruited~     from two government school of Mangali village situated in Hisar district of Haryana state.~      Study design: This intervention study will be carried out in a randomized controlled design.~     Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores~     (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.~   "
142347|NCT01191450|"~     The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg +~     amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial~     hypertension.~   "
142348|NCT01191424|"~     The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of~     Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the~     NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP,~     Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a~     free combination of BDP DPI plus FF DPI licensed products after a morning dose~     administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult~     asthmatic patients.~   "
142349|NCT01191411|"~     Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can~     prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations~     such as those with limited or no health insurance. This striking public health challenge~     demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.~      Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to~     complete CRC screening may result in increased rates of screening completion. However, this~     approach has not been tested extensively in vulnerable populations, such as the~     under/uninsured, and minority populations often cared for by safety-net health systems.~     Further, it is unclear whether patients are more likely to participate in one CRC screening~     test versus another. Knowing this is important to designing programs for increasing~     screening. For example, the planning and resources required for a screening program with~     colonoscopy--which is a sensitive but invasive and expensive test--are very different from a~     program with that uses stool testing to detect microscopic blood such as an immunochemical~     stool blood test--which is a less sensitive, but non-invasive and cheap test.~      Also, it is possible designing a program with a less sensitive, but more acceptable test~     could prevent more CRC death if participation in screening is test specific. For example, if~     many more patients participate in an immunochemical stool blood test based program than a~     colonoscopy based program, even though the immunochemical stool blood test is less~     sensitive, the program may save more lives because more patients are reached.~      The aims of this trial are to:~      Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders,~     and systematic clinical follow up) to uninsured, unscreened patients cared for by the~     safety-net health system serving Tarrant County, Texas. Patients will be invited to either:~        1. Complete a free home-based, non-invasive immunochemical stool blood test~        2. Complete a free colonoscopy~      Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program~     costs.~      The primary outcome is screening completion.~   "
142350|NCT01191398|"~     The purpose of this study is to determine if the antisialagogues (anti-salivary agents),~     Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating~     patients with Ketamine for procedural sedation in the emergency department or abscess~     clinic. The investigators will measure salivary flow rate by collecting oral secretions by~     oral suctioning over a 30 minute time period starting with the administration of Ketamine.~     The investigators hypothesize that patients who receive either atropine or glycopyrrolate~     will have fewer oral secretions than patients who receive placebo.~   "
142351|NCT01191385|"~     This study is an international prospective, open-label, multi-center, non-interventional~     study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a~     decision to treat with sorafenib has not been made at time of study enrollment. All patients~     will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the~     study. Detailed information concerning the past medical/surgical history, performance~     status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and~     practice patterns of the physicians involved in the care of patients with HCC under~     real-life conditions will be evaluated.~   "
142352|NCT01191372|"~     The purpose of this study is to examine the safety, tolerability and the way the body~     handles various single and multiple doses of ARC19499 in patients with hemophilia.~   "
142353|NCT01191359|"~     Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS~     Birch in regard to pharmacodynamic efficacy and tolerability.~   "
142354|NCT01191346|"~     The purpose of this research study is to see if a higher strength MRI procedure provides~     better images to use in planning radiation treatments for patients with brain tumors in the~     future.~   "
142355|NCT01191333|"~     The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic~     Stimulation (rTMS) helps people with depression who have not been helped by medications or~     who have not been helped enough by medications.~   "
142356|NCT01191320|"~     The purpose of this study is to determine the effect the investigative drug has on glycemic~     control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism~   "
142357|NCT01191307|"~     The ASK CHILDREN study is intended to aid in future development of various neurologic~     devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information~     obtained to identify more efficient strategies in the evaluation and review of~     neuroprostheses regulated by the Agency.~   "
142358|NCT01191294|"~     The investigators will design a curriculum for visual screening for melanoma and skin biopsy~     procedure, based on the mastery learning model, using simulators and web-based didactic~     instruction for medical students and internal medicine residents. This requires having a~     skin simulation model that presents a range of lesions from benign nevus to atypical nevus~     to melanoma in a distribution and density that mimics the clinical findings of those with 2~     skin tones: fair-skin non- Hispanic white and Hispanic.~   "
142375|NCT01191073|"~     In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM)~     fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared~     with a traditional fabricated RPD for 50 consecutive patients.~      During 5 years the patients are in a follow-up program in order to judge long-term~     stability, loss of retention, fractures, … of both groups of dentures.~   "
142359|NCT01191281|"~     The purpose of this three-year study is to develop, implement, and pilot test a culturally~     appropriate, multi-component nutrition intervention for people living with HIV and food~     insecurity in Honduras, which is among the Latin America nations with the highest HIV~     prevalence rates. The investigators specific aims are to:~        1. Explore the relationships between food security, nutrition, and HIV treatment access,~          utilization, and adherence, and examine key mediators and moderators of these~          relationships.~        2. Develop a multi-component nutrition intervention to address food insecurity among~          Honduran HIV+ individuals and their families.~        3. Evaluate the preliminary effectiveness of the intervention on (1) food security and~          nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when~          recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects,~          and opportunistic infections).~        4. Examine key mediators and moderators of the intervention effects from among~          characteristics of the patient, household, and contextual setting.~   "
142360|NCT01191268|"~     The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to~     Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in~     participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.~   "
142361|NCT01191255|"~     This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in~     ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.~   "
142362|NCT01191242|"~     Methadone has been an effective and inexpensive therapy in the management of chronic pain~     and opioid dependence. However it has been associated with sudden, unexpected deaths. Two~     mechanisms have been suggested, increased drug concentration in the blood, and a change in~     the heart rhythm. This study will look at blood samples for drug levels and genetic~     components and EKG's (a noninvasive test which reveals heart rhythm). There will be no~     intervention.~   "
142363|NCT01191229|"~     The study is being conducted to collect information about visual outcomes and participant~     satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared~     with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S.~     Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual~     correction of aphakia (replacing a removed lens in the eye) in adults.~   "
142364|NCT01191216|"~     This phase I trial is studying the side effects and best dose of giving~     1-methyl-d-tryptophan and docetaxel together in treating patients with metastatic solid~     tumors. Biological therapies, such as 1-methyl-d-tryptophan, may stop the growth of tumor~     cells by stimulating the immune system and by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     1-methyl-d-tryptophan with chemotherapy may kill more tumor cells.~   "
142365|NCT01191203|"~     The IUD is an extremely effective method of contraception yet few women use it worldwide.~     Considered safe to use in HIV+ women, few studies have evaluated its use among those using~     antiretroviral therapy. The only prior randomized trial looking at the IUD compared to~     hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD~     acceptability and continuation is critical to improve utilization.~        -  Objective 1: Determine WHO medical eligibility and the willingness for IUD placement~        -  Objective 2: Compare method-related side effects and adverse events~        -  Objective 3: Assess the 1-year acceptability and continuation rates~      Methods: To address our objectives the investigators have designed a two Phase Study:~        -  A cross-sectional screening to evaluate contraceptive medical eligibility and~          desirability~        -  A randomized controlled trial that will compare acceptability and adherence to DMPA~          compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to~          follow for 1 year~   "
142366|NCT01191190|"~     Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will~     be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three~     consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR)~     to therapy and the secondary endpoints will assess the safety and tolerability of the~     regimen, the impact of the treatment on progression free, treatment free, overall survival,~     and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis~     prophylaxis and antimicrobial prophylaxis.~   "
142367|NCT01191177|"~     The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in~     normalizing liver function in patients who have parenteral nutrition associated liver~     disease. The investigators believe that patients who take oral fish oil will normalize liver~     function faster than those who do not~   "
142368|NCT01191164|"~     Background: Recent single arm studies have suggested that partial breast irradiation (PBI),~     delivered in a relatively short overall treatment time of a few days, may be an effective~     alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks.~     Several PBI modalities and techniques have been investigated, including interstitial~     brachytherapy and external beam radiation therapy, most often given over the course of one~     week of twice daily outpatient treatments. One randomized study has shown equivalency~     between WBI and PBI using brachytherapy. There are currently three large phase-III~     randomized studies comparing PBI to WBI.~      Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at~     the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it~     requires only one out-patient procedure. The treatment is administered by implanting~     radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient~     procedure, after which the patient is discharged home to resume her normal living~     activities. This PBI procedure was shown to be well tolerated with minimal acute toxicity.~     Estimated partner radiation exposure was well within internationally acceptable levels.~     Subjects with a seroma >2cm were, however, excluded.~      Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and~     her partner in the context of medical practice and resources in BC.~      Objectives: In subjects who have undergone breast conserving surgery for early breast~     cancer:~        1. To determine the technical feasibility of PBSI in BC~        2. To measure the subject's partner in terms of radiation protection~        3. To evaluate acceptability of PBSI by the subject~        4. To assess resource requirements for PBSI~      Method: This is a single arm feasibility study. Five women who had undergone breast~     conserving surgery for breast cancer with low risk of local recurrence will be accrued. This~     study will adhere to a detailed written protocol for radiation measurements and protection.~      Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be~     performed in an outpatient setting, under conscious sedation and local anesthesia, by a team~     with a wide brachytherapy experience. The technique used in this feasibility study will be~     based on the OCC technique. It is intended that two oncologists and one physicist will spend~     2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as~     implemented at that centre.~      The OCC technique is US-based; in this study, however, an additional CT-assisted planning~     component will be investigated building on the experience of the VIC team which conducted~     the BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter~     brachytherapy PBI.~      Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant~     chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5~     years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded.~      Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could~     significantly improve QOL and convenience for patients choosing breast conserving therapy.~     Confirming the technical feasibility and safety of PBSI is needed before progressing to~     larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable~     treatment option for women in British Columbia.~   "
142369|NCT01191151|"~     The purpose of this study is to establish an international, web based clinical registry to~     collect baseline characteristics of patients undergoing orthopaedic, sports medicine,~     arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness~     associated with the surgical procedures and nonoperative treatments.~   "
142370|NCT01191138|"~     Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric~     emptying.~      The study compares two types of anastamosis of stomach to jejunum (supracolic and~     infracolic) and compares whether it influences the gastric emptying.~      The clinical evidence of delayed gastric emptying is correlated with objective evidence of~     liquid and solid emptying by radionuclide study.~      The study also tries to evaluate whether pancreatic leak correlates with delayed gastric~     emptying~   "
142371|NCT01191125|"~     To evaluate the effect of an experimental oral nutritional supplement containing AN777~     compared to another oral nutritional supplement in a malnourished, elderly population.~   "
142372|NCT01191112|"~     The objective of this study is to determine the safe use and tolerance of a peptide-based~     formula in children with gastrointestinal dysfunction and/or feeding intolerance.~   "
142373|NCT01191099|"~     A single-center cohort study to identify uni- and multivariate associations between marker~     gene expression and clinico-pathological parameters for the detection of robust and novel~     prognostic tools in prostate cancer~   "
142374|NCT01191086|"~     The purpose of this study is to examine the safety of USL255 as adjunctive therapy in~     patients with refractory partial onset-seizures.~   "
142377|NCT01191034|"~     Human cancers express tumor antigens that can be targeted by cytolytic T lymphocytes (CTL).~     These antigens consist of a small peptide, derived from endogenous proteins, that is~     presented at the cancer cell's surface by an HLA class I molecule. Such antigenic peptides,~     including MAGE-3.A1 and NA17.A2, have been tested in experimental therapeutic vaccines to~     elicit CTL responses in cancer patients, mainly with metastatic melanoma. Up to now, only~     rare tumor responses have been observed.~      Tumor resistance to CTL killing is the most likely explanation for the poor effectiveness of~     cancer vaccines. This resistance is probably acquired by the tumor during its development~     and selected by its repetitive challenge with spontaneous anti-tumoral immune responses. The~     precise molecular mechanisms of tumor resistance remain unknown. The observation that~     tumor-infiltrating lymphocytes (TIL) purified from melanoma metastases can recognize and~     kill autologous tumor cells in vitro, whilst they seem unable to control tumor growth in~     vivo, suggests that this resistance is hosted by the tumor environment, rather than being~     the result of a generalized immune suppression.~      The investigators have developed a murine model of cutaneous graft rejection that mimics the~     situation in melanoma. Female CBA mice do not reject syngeneic male skin grafts, even though~     they mount a spontaneous CTL response against H-Y, a male specific minor histocompatibility~     antigen, following grafting. The investigators have tested various experimental procedures~     aimed at inducing effective graft rejection in these mice. This was obtained with a~     combination of IFN-α, IL-2, GM-CSF, each administered separately under the skin graft,~     associated with topical applications of imiquimod. All these agents are available as~     registered drugs. Based on this murine model of cutaneous allograft rejection, the~     investigators postulate that local immunomodulation with this combination can trigger an~     effective tumor rejection process, and induce a more efficient and long-lasting anti-tumoral~     immune response following peptide vaccination.~   "
142378|NCT01191021|"~     This trial investigates the relationship between concentrations of the anesthetic drug~     propofol in exhaled breath, blood and drug effect in volunteers undergoing general~     anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model~     for propofol in exhaled breath.~   "
142379|NCT01191008|"~     The objective of this Investigation is to evaluate the safety and efficacy of long-term~     treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse~     drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey~     period, and whether an additional treatment outcome investigation and/or a post-marketing~     clinical study is required in the future will be determined.~   "
142380|NCT01190995|"~     Procedural pain in neonates is recently acknowledged entity and many studies on the use of~     pharmacological as well as non pharmacological interventions for alleviation of this pain~     have been done. Of these, sucrose with or without non nutritive sucking has been the most~     widely studied and accepted form of pain relief. Its analgesic effect is thought to be~     mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).~      Although, guidelines based on systematic reviews and meta-analysis for pain management~     recommend the use of sucrose solutions for pain relief during procedures, the use of~     repeated doses of sucrose with preterm neonates requires further investigation.~      Pain may have profound consequences for preterm neonates during a critical time of brain~     development. Data derived from animal models suggests that repeated painful stimuli may~     result in structural and functional reorganization of the nervous system and alteration in~     future pain response. Early pain experience during this critical period in development are~     thought to have immediate and long term consequences that could influence physiological,~     behavioral and developmental outcomes. Early repetitive procedural pain related stress in~     very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1~     This study aims to assess the effect of repeated painful stimuli on short term~     neurobehaviour of preterm infants and the efficacy of repeated doses of sucrose used for~     pain relief.~   "
142381|NCT01190982|"~     LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc.~     Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active~     in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the~     solubility, this drug is formulated with polyoxyethylated castor oil, which leading to~     infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a~     mixture of well characterized, synthetic phospholipids and cholesterol. This design~     eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is~     necessary for administering higher doses than would commonly be used with Taxol. The~     clinical evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated~     than Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II~     study is designed to accomplish the following objectives:~        1. Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after~          administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU~        2. To evaluate the Progression-Free Survival (PFS)~        3. To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral~          neuropathy~        4. To evaluate the Overall Survival (OS)~   "
142382|NCT01190969|"~     The purpose of this study is to determine whether short-term use of oral nutritional~     supplements as part of the diet improves nutritional and functional status of~     post-hospitalization malnourished elderly.~   "
142383|NCT01190943|"~     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the~     laboratory may help doctors learn more about changes the occur in DNA and identify~     biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how~     well patients will respond to treatment.~      PURPOSE: This research study is studying DNA biomarkers in tissue samples from patients with~     osteosarcoma.~   "
142384|NCT01190930|"~     This partially randomized phase III trial studies different combinations of risk-adapted~     chemotherapy regimens and their side effects and comparing how well they work in treating~     younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or~     B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began~     (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving more than one drug (combination chemotherapy), giving the drugs in~     different doses, and giving the drugs in different combinations may kill more cancer cells.~   "
142385|NCT01190917|"~     The purpose of this study is to compare two different treatment approaches to social skills~     groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will~     examine changes in both behavior and the brain following treatment.~   "
142400|NCT01190722|"~     The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a~     better patients assessed overall satisfaction when used for pain management after elective~     hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs~     (NSAIDs).~   "
142401|NCT01190709|"~     The purpose of this study is to determine which surgical approach is better for treatment of~     tibial shaft fracture~   "
142386|NCT01190904|"~     The purpose of this study is to find out if androgen deficiency (low levels of testosterone,~     a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction)~     will predict over time the development of a heart attack, stroke, or death in men with~     Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with~     or without percutaneous coronary intervention (PCI). A substudy aims to show the different~     factors and processes that may show a relationship between sexual function and levels of~     androgen in the body to heart disease.~   "
142387|NCT01190891|"~     The purpose of this study is to evaluate and compare the short and long-term effectiveness~     of two common interventions, manual physical therapy versus corticosteroid injection, for~     the treatment of shoulder impingement syndrome.~   "
142388|NCT01190878|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in~     topical administration of differing dosing regimens of ISV-303 compared to vehicle and~     Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.~   "
142389|NCT01190865|"~     The goal for this study is to examine the persistence of growth~     arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product~     HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured~     using Y-STR for detection of Y-chromosome.~   "
142390|NCT01190852|"~     The primary objective is to assess the effect of fluticasone propionate (FLU) on the~     relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as~     fixed AZE-FLU combination product (TEST) compared to a similar formulation without~     containing FLU (i.e. AZE alone; REF).~      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when~     administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product~     Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic~     parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.~   "
142391|NCT01190839|"~     REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in~     an experiment to see if it may be useful in preventing relapse of Crohn's disease after~     surgical resection. This study will compare the effects (both good and bad) of REMICADE~     (infliximab) to those of placebo. Placebo looks like the drug being studied but has no~     active ingredients.~   "
142392|NCT01190826|"~     The purpose of this study is to evaluate the safety, tolerability and clinical activity of~     ASM-024 in stable moderate asthma.~   "
142393|NCT01190813|"~     The purpose of this study is to evaluate the efficacy and safety of oral levodopa and~     patching versus oral placebo and patching as treatment for residual amblyopia in children 7~     to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.~   "
142394|NCT01190800|"~     The purpose of this study is to assess decision-making capacity in persons with Alzheimer's~     disease. First, our goal is to validate four French capacity assessment tools for persons~     with Alzheimer's Disease : a French version of the Competency Assessment Tool for Consent to~     Treatment and of the Competency Assessment Tool for Voting, two questionnaires assessing the~     capacity to appoint a proxy either to consent to treatment or to vote. Second, once~     validated, we plan these questionnaires to study decision-making abilities and their~     determinants in persons with Alzheimer's disease and control subjects.~   "
142395|NCT01190787|"~     This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess~     the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose~     melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone~     (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).~   "
142396|NCT01190774|"~     Dental anxiety is a significant barrier to the acceptance of regular dental care, and has~     many negative consequences. A study by Dailey et al. (2002) found that providing the dentist~     with information of the high level of a patient's dental anxiety prior to treatment using~     the Modified Dental Anxiety Scale (MDAS, Humphris et al., 1995), lead to a significant~     reduction in state anxiety from pre- to post- dental consultation compared to a control~     group. The current study aimed to replicate the study by Dailey et al. (2002), and to~     further explore whether the reduction in state anxiety associated with the MDAS could be~     explained by a change in dentist behaviour on receiving it, or a change in patient~     expectancy about the treatment session, or both.~      The design was a randomised control trial involving three groups, which aimed to manipulate~     possible changes in dentist behaviour and patient expectancy. In Group 1, the MDAS was left~     at reception, as expected by the patient. In Group 2, the dentist received the MDAS,~     although the patient did not expect this. In Group 3 the dentist received the MDAS and the~     patient did expect this. The sample (N=182) was taken from two dental access centres, and~     included participants obtaining a score of 19 or above, or 5 on any one item of the MDAS.~     Pre- and post-dental consultation measures of state anxiety were taken using the six-item~     short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-S,~     Marteau & Bekker, 1992).~   "
142397|NCT01190761|"~     The objective of this study was to compare the rate and extent of absorption of Purepac, a~     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,~     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fed conditions.~   "
142398|NCT01190748|"~     The objective of this study was to compare the rate and extent of absorption of Purepac, a~     subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P.,~     U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fasting conditions.~   "
142399|NCT01190735|"~     Numerous epidemiological studies have linked lifelong use of caffeine to a lower risk of~     Parkinson's disease (PD) - prospective studies have estimated that non-coffee drinkers have~     an approximately 1.7-2.5 fold increased risk of developing PD compared to coffee drinkers.~     This is an extremely important finding which deserves further more in depth investigations.~      The exact pathophysiological mechanism remains elusive, but multiple hypotheses do exist:~     Caffeine antagonizes adenosine receptors directly yielding an improvement on motor systems~     and even on Levodopa serum concentrations (when on therapy). An additional explanation is~     that adenosine antagonism has neuroprotective properties by acting locally on basal ganglia~     circuits and the substantia nigra.~      The current study aims to identify the optimal caffeine dose with maximal motor benefit and~     the least amount of undesirable adverse effects.~   "
142402|NCT01190696|"~     The purpose of this study is to determine which method is better for treatment of femoral~     fracture in children in outcomes.~   "
142403|NCT01190683|"~     Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are <20 ng /ml in up~     to 90% of them. Recently, in a randomized control trial, investigators have shown that dual~     cholecalciferol and calcium supplementation lead to significant improvement in hand grip~     strength and distance covered during six minutes walk test. Present study is being taken to~     further understand the functional significance of 25(OH)D in terms of its effect on Skeletal~     muscle strength including surface electromyography (EMG) in a larger cohort involving~     approximately 200 subjects. The impact of calcium and vitamin D supplementation would be~     assessed by supplementing them alone and in combination. Besides, the investigators would~     also assess impact of above supplementation on Th1/Th2 cytokines expression in the~     peripheral mononuclear cells.~   "
142404|NCT01190670|"~     The objective of the study is to characterize the effect of multiple doses of ASP015K on the~     pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.~   "
142405|NCT01190657|"~     This is a self-controlled, open, multiple-center clinical trial.~   "
142406|NCT01190644|"~     What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by~     dosing with Sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene~     has determined that all of these goals could be obtained by an intense 10 patient,~     Sotatercept (ACE-011) pharmacodynamic study, completed by two well known experts in the red~     cell production field.~   "
142407|NCT01190631|"~     The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL~     implantation, and to determine if an association exists between TSA, postoperative high~     order aberrations (HOA), and functional vision following IOL implantation in patients~     grouped by pre-operative corneal spherical aberration (CSA).~   "
142408|NCT01190618|"~     The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair~     with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair~     with Prolift. .~   "
142409|NCT01190605|"~     Women with HIV infection in Mississippi who are pregnant or who have had their baby in the~     past year can agree to fill out a questionnaire about what helps or hurts return to care for~     HIV infection after having a baby. The combined results should show the most common things~     that keep women from getting care for HIV infection after having a baby. This will help~     design another study in order to help more women get into care for HIV infection after~     having a baby.~   "
142410|NCT01190592|"~     The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk)~     supervised, progressive RT program with increased daily milk intake in untrained adolescents~     on measures of body composition and cardiovascular risk factors. The investigators~     hypothesize that milk supplementation will produce significantly greater favorable changes~     in all body composition measures compared with RT + carbohydrate and control.~   "
142411|NCT01190579|"~     The trial will investigate the accuracy of Dual Source CT coronary angiography to detect~     coronary artery stenoses in patients with chest pain who have, based on clinical criteria,~     an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers~     will be used to lower the heart rate for the examination. The hypothesis is that Dual Source~     CT will allow the detection of vessels with at least one coronary artery stenosis with a~     sensitivity of more than 90%.~   "
142412|NCT01190566|"~     The purpose of this study is:~      To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging~     in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced~     breast cancer patients.~      To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI,~     dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring~     response to neoadjuvant chemotherapy of locally advanced breast cancer patients.~      To compare the performances of dynamic contrast-enhanced MRI using parametric response map~     analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early~     prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer~     patients~   "
142413|NCT01190553|"~     This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with~     PARKINSON'S Disease who are not well balanced with medical treatment.~   "
142414|NCT01190540|"~     This evaluation aim is to investigate a cost-effective way to build capacity for the care~     and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan~     Africa. Classroom based training continues to be the dominant form of training, despite~     evidence that suggests that on-site support (OSS) is more beneficial. Definitive evidence~     that on-site support is the most effective way to deliver the required outputs and related~     outcomes is still lacking. IDCAP will provide two interventions that integrate training in~     TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be~     studied: 1) Integrated Management of Infectious Disease (IMID) training program for~     individual MLP, and 2) On-site support (OSS) for team of health professionals. This study~     employs a mixed design with pre/post and cluster randomized trial components. Interventions~     are at the level of the individual participant for IMID and at the level of the site (health~     facility) for OSS. All participants attend a 3-week course, followed by two 1-week booster~     courses over a six month period. After the 3-week course, a randomized arm of half the~     sampled facilities also received OSS every month for 9 months and bi-monthly for 6~     additional months.~   "
142430|NCT01190332|"~     One of the new methods for management of common bile duct stones is intraoperative~     endoscopic sphincterotomy. It can be performed by many techniques. In the study the~     investigators compare two methods to find out the best technique for intraoperative~     endoscopic sphincterotomy.~   "
142431|NCT01190319|"~     The specific aim of the study is to determine whether a freeze dried powder provided by the~     California Strawberries Commission, can reduce blood pressure in patients with~     pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).~   "
142432|NCT01190306|"~     The purpose of this research study is to test the safety, tolerability, and effectiveness of~     corneal collagen cross-linking (CXL), when used to treat keratoconus.~   "
142433|NCT01190293|"~     The purpose of the study aims is to help determine whether it is safe to change directly~     from efavirenz to maraviroc in patients who are stable on an efavirenz-containing regimen.~     The pharmacokinetics (drug levels) of efavirenz and maraviroc when efavirenz is stopped and~     maraviroc is started will be assessed.~      Both the study patients and the study team will know which treatment is being taken at all~     times in the study.~   "
142415|NCT01190527|"~     Successful treatment of non-small cell lung cancer with radiation therapy requires that the~     physicians determine exactly where the tumor is in your body, and protect your normal~     tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron~     Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if~     the procedure helps predict how well the treatment works for your cancer and how well your~     lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a~     radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A~     Computerized Tomography (CT) will also be performed along with both of these procedures to~     help the researchers see clearly where your cancer or your healthy lung is located. The~     study will help the investigator determine whether an adaptive plan that is applied based on~     repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there~     is an improvement in treatment outcome compared to those treated with standard radiation~     therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the~     total dose of your treatment based on the risk of damage to your healthy lung tissue. While~     increasing the radiation dose, but limiting the toxicity to normal lung tissue, the~     researchers hope to improve your tumor control.~   "
142416|NCT01190514|"~     To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of~     DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.~      To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after~     administration of 50 mg SR formulation of DVS.~   "
142417|NCT01190501|"~     Our main objective is to assess whether aortic stiffness is a predictor of blood pressure~     response after surgery in patients with an aldosterone producing adenoma or a unilateral~     adrenal hyperplasia.~   "
142418|NCT01190488|"~     The investigators propose an evaluation of an end of life patient decision aid (EOL-PtDA)~     developed by the Foundation for Informed Medical Decision Making using the RE-AIM (Reach~     Effectiveness, Adoption, Implementation, and Maintenance) framework. To evaluate the Reach~     and Effectiveness, the investigators propose a pilot randomized clinical trial of the~     EOL-PtDA among patients on the inpatient palliative care service at University Hospital in~     Colorado. To evaluate barriers and facilitators of Adoption, Implementation, and Maintenance~     of the EOL-PtDA, we propose focus groups of non-palliative care physicians as we perceive~     these physicians to be the largest barrier to ultimate adoption of the EOL-PtDA.~     Additionally we propose a focus group of the palliative care physicians who participated in~     the implementation of this decision guide study to evaluate the feasibility of conducting a~     randomized control trial within a pall. care service and to evaluate the acceptability of~     this decision aid as it was implemented. The investigators also propose to conduct focus~     groups of normal, healthy clinic patients to determine the acceptability among that~     population. The End-of-Life decision aid is different from other decision aids. From the~     vantage point of decision quality, a major difference is that its primary focus is on~     helping patients clarify their values rather than gain knowledge. The results from this~     study will provide critical preliminary data to inform a randomized clinical trial and/or~     widespread implementation of the EOL-PtDA.~      Specific Aims/Research question(s):Aim 1: To determine the Reach and Effectiveness of an~     end-of-life patient decision aid by conducting a pilot randomized clinical trial in an~     inpatient palliative care service. Aim 2: To determine physicians' attitudes towards the~     end-of-life patient decision aid and to gain insights into potential barriers and~     facilitators to Adoption, Implementation, and Maintenance by conducting a qualitative study~     of non-palliative care, and separately, palliative care physicians. Aim 3: To determine~     healthy clinic patients' attitudes towards the end-of-life patient decision aid and to gain~     insight into its Reach and Effectiveness.~   "
142419|NCT01190475|"~     This study will assess the safety and tolerability of BGS649 in women with moderate to~     severe endometriosis.~   "
142420|NCT01190462|"~     RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different~     ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and~     help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help~     cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab~     together with simvastatin may kill more tumor cells.~      PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in~     treating patients with advanced or metastatic colorectal cancer.~   "
142421|NCT01190449|"~     RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different~     ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells~     and help kill them or carry cancer-killing substances to them.~      PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in~     treating patients with previously untreated stage II, stage III, or stage IV follicular~     non-Hodgkin lymphoma.~   "
142422|NCT01190436|"~     The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm~     study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day~     bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on~     therapy.~   "
142423|NCT01190423|"~     Temple University is conducting a National Institute of Health funded research study~     designed to develop and refine a family-based treatment manual for young adults with~     Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.~   "
142424|NCT01190410|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely~     active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics~     (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to~     severely active Crohn's disease.~   "
142425|NCT01190397|"~     The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands~     in the eyelids~      Phase I, prospective, comparative study, investigator masked , monocentric~      Objectives are To assess and compare the warming and moisture of Blephasteam® device versus~     the warming and moisture of warm and moist compresses.~      To assess and compare safety on the ocular surface after 10 minutes of Blephasteam®~     application versus after 10 minutes of warm and moist compresses application~   "
142426|NCT01190384|"~     Determine whether eating beans with a high fat meal will reduce the inflammatory response in~     people with the metabolic syndrome and increase feelings of satiety.~   "
142427|NCT01190371|"~     The purpose of this study is to determine whether P. falciparum infections in Kilifi~     District have developed tolerance to the artemisinin class of drugs.~   "
142428|NCT01190358|"~     The purpose of this study is to determine whether taking grape seed extract prior to eating~     a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.~   "
142429|NCT01190345|"~     The purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by~     the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of~     pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer~     receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.~   "
147723|NCT01120795|"~     The purpose of this study is to see if treatment of chronic hepatitis C in people who are on~     opiate replacement therapy such as methadone or buprenorphine (including patient who still~     inject drugs) is safe and effective.~   "
142434|NCT01190280|"~     The aim of the study is to identify patients with gallstone disease that should be operated~     and those that may potentially be observed. This selection was based on symptoms and~     clinical presentation. The consequences that may arise for the patient if observation is~     chosen compared with outcome after cholecystectomy has been markers of outcome.~   "
142435|NCT01190267|"~     This study is designed to evaluate whether asenapine, which is approved by the United States~     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is~     generally safe and well tolerated in adolescents with schizophrenia. This is an extension of~     base study P05896 (NCT01190254), which means participants must have completed participation~     in the 8-week base study in order to qualify for this extension study P05897. Participants~     in this extension study will receive open-label asenapine for 26 weeks. Throughout the~     study, observations will be made on each participant at various times to assess the~     long-term safety, tolerability and efficacy of the study treatment.~   "
142436|NCT01190254|"~     This study is designed to evaluate whether asenapine, which is approved by the United States~     Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is~     also effective in adolescents with schizophrenia. Participants who qualify for the study~     will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice~     daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each~     participant at various times to assess the efficacy and safety of the study treatment. The~     primary objective of the trial is to demonstrate significant superiority of at least one~     asenapine dose to placebo, as measured by the change from baseline of the Positive and~     Negative Syndrome Scale (PANSS) total score at Day 56.~   "
142437|NCT01190241|"~     The purpose of this study is to select targeted treatment based on ex vivo kinase activity~     inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer~     for whom no standard treatment is available.~   "
142438|NCT01190228|"~     The aim of the study is to investigate the memory immune response and the yearly persistence~     of the immunity against Japanese Encephalitis (JE) after vaccination with a new Japanese~     Encephalitis Chimeric Virus (JE-CV) in participants previously vaccinated with JE-CV.~      Objectives:~        -  To describe JE immune status before, and after a JE-CV booster dose in subjects~          previously vaccinated with JE-CV~        -  To describe the immune status before, and immune response following JE-CV vaccination~          in JE-naïve control subjects.~        -  To describe the safety (in terms of solicited and unsolicited adverse events) of a~          single dose of JE-CV up to 6 months after the last vaccination.~        -  To describe all related serious adverse events (SAEs) and related deaths from 6 months~          to 5 years after vaccination in JE-CV-primed subjects.~   "
142439|NCT01190215|"~     This study is designed to assess the immunogenicity, reactogenicity and safety following~     vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been~     vaccinated with one dose of PandemrixTM at the age of 10-17 years.~   "
142440|NCT01190202|"~     The aim of this epidemiology study is to characterize in a standardized way malaria~     transmission intensity at the clinical trial centers participating in study 110021~     (NCT00866619).~   "
142441|NCT01190189|"~     This extension study is designed to assess the safety of GSK Biological's human~     papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study~     NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV~     vaccine is not indicated for the subject's age group (26 years and older). This study is~     thus conducted to enable all women who received the control placebo in the primary~     NCT00294047 study to receive the GSK580299 vaccine.~   "
142442|NCT01190176|"~     This study is intended to provide up to a maximum of four years of annual oncogenic human~     papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study~     subjects who displayed normal cervical cytology but tested positive for oncogenic HPV~     infection at their concluding NCT00294047 study visit.~      Women who were pregnant at their concluding NCT00294047 study visit may also be included in~     this study, as no cervical sample could be collected at that visit.~      The objectives and outcome measures of the primary phase (NCT00294047) are presented in a~     separate protocol posting.~   "
142443|NCT01190163|"~     This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in~     unfavorable cervix pregnant women with 38 or more weeks of gestational age.~   "
142444|NCT01190150|"~     This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic~     acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female~     subjects ages 12-16 years with heavy menstrual bleeding.~   "
142445|NCT01190137|"~     There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2~     (plant source). Almost all the usual vitamin D preparations for infants available in~     Canadian pharmacies contain vitamin D3 which may not be suitable for families who avoid~     animal products for social or religious reasons. The purpose of this study is to learn more~     about the two forms of vitamin D and if blood levels of vitamin D are similar in infants~     after taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of~     either vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference~     in blood vitamin D levels, after 3 months of supplementation, between the two groups will~     help determine if the two supplements are equal.~   "
142446|NCT01190124|"~     The purpose of this study is to evaluate the efficacy of raltegravir with optimized~     background therapy (OBT) in multiple-experienced HIV infected patients, measured by the~     proportion of patients with undetectable viral load and the mean increase of CD4 cells count~     at week 24 and 48.~      It is also intended to evaluate:~        -  viral load suppression and the mean increase of CD4 cells count at week 24 and 48 in~          patients who needed to change antiretroviral (ARV) therapy due to inacceptable~          toxicity, as determined by the investigator, including patients who needed to replace~          T20.~        -  efficacy of raltegravir with OBT in HIV-2 infected patients that were included in this~          cohort, measured by the percentage of patients with undetectable viral load and the~          mean change of CD4 cells count at week 24 and 48.~      Study hypotheses:~        -  Raltegravir with OBT is effective in achieving and maintaining a long term virologic~          suppression along with a significant increase on CD4 cells count in both HIV-1 and~          HIV-2 infected patients.~        -  Patients who replaced T20 by raltegravir, due to intolerance, are able to maintain long~          term virologic suppression.~   "
142448|NCT01190098|"~     Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a~     negative impact on quality of life. Though unproven, these problems are often blamed on~     anti-seizure medications. The purpose of this study is to investigate the impact of the~     anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal~     (partial onset) seizures.~      Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures~     arising from a localized network of neurons in the brain. Focal seizures usually begin a~     sensation or involuntary movement of a part of the body, an unusual feeling, or a~     disturbance in hearing, smell, vision, or consciousness. The study is open to adults 18 and~     older with focal seizures.~      Participation involves a physical exam, sleep testing at the Sleep Center, blood tests,~     completion of study questionnaires/diaries, and a random assignment to either take the study~     drug or placebo (often called a look alike or sugar pill) for 5 to 8 weeks. There are 5~     study visits. Participants will receive compensation for time spent in the study.~      If you would like more information on this study please contact the Cleveland Clinic Sleep~     Center:~      Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718~   "
142449|NCT01190085|"~     Only a few medications are approved for the treatment of alcohol dependence and there exists~     a substantial need for discovering ways to provide more effective treatments. Accordingly,~     identifying new potential neuropharmacological targets in the treatment of alcohol~     dependence represents a high priority in public health. Ghrelin is a 28-amino acid peptide~     acting as the endogenous ligand for the growth hormone secretagogue receptor (GHS-R).~     Ghrelin was first isolated from the stomach, but a central hypothalamic production of~     ghrelin has also been demonstrated. Ghrelin plays a key role in the regulation of appetite.~     Consistent with the common neurobiological substrates for control of food and alcohol~     consumption, preclinical investigations suggest that ghrelin plays a role in the~     neurobiology of alcohol dependence, thus representing a new potential neuropharmacology~     target. In keeping with the preclinical studies, human investigations showed that alcohol~     consumption affects blood ghrelin levels and that blood ghrelin levels significantly and~     positively correlate with craving measurements in alcohol-dependent individuals. The effects~     of exogenous ghrelin injected intravenous (i.v.) in alcohol-dependent individuals, however,~     have never been investigated. The current project proposes a randomized double-blind~     placebo-controlled 3-group between-subject laboratory study aimed at investigating the~     effects of exogenous ghrelin i.v. on non-treatment seeking alcohol-dependent subjects in~     terms of urges to drink, attention to cues and related psychophysiological measures. This~     project has the goals to: i) conduct an alcohol laboratory study testing the role of ghrelin~     i.v., therefore demonstrating the feasibility of such a study and the safety of ghrelin i.v.~     when administered to alcohol-dependent individuals; and ii) explore the effects of ghrelin~     i.v. on alcohol craving assessed under controlled conditions, such as a cue-reactivity (CR)~     experiment.~      This study will address whether alcohol craving is affected when ghrelin levels are modified~     acutely via a ghrelin i.v. injection. Given the crucial need to expand our understanding of~     the underlying neurobiology of alcoholism, this study potentially will lead to identify new~     targets for the development of pharmacological treatments that may improve interventions for~     alcohol dependent individuals.~   "
142450|NCT01190072|"~     The purpose of the study is to follow the management of blood lipids in patients with~     planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6~     to 10 weeks after the intervention.~   "
142451|NCT01190059|"~     The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for~     donor lungs that fail to meet standard acceptability criteria. This advanced assessment~     might lead to increased utilization rates of donor lungs and improved outcomes after lung~     transplantation.~   "
142452|NCT01190046|"~     The purpose of this study is to define the effects of chronic disuse on skeletal muscle~     structure and function in elderly individuals at the cellular and molecular level by~     examining elderly characterized by chronic muscle disuse (patients with knee osteoarthritis)~     and healthy elderly no evidence of knee osteoarthritis and normal physical activity levels.~   "
142453|NCT01190033|"~     This is a prospective, randomized, double-blind, placebo-controlled study. In an initial~     phase, 100 patients with chronic low back pain will be included in this study. The patients~     will be recruited through magazines and newspapers to take part in a screening for treatment~     of low back pain. This screening will involve the evaluation of data such as history and~     physical examination to classify the patient in the group of nonspecific low back pain,~     excluding patients with neurological alterations and the so-called Red-Flags.~      Procedures After the initial screening the patients will undergo diagnostic blocks of the~     medial branch of lumbar vertebrae L2, L3, L4 , L5 and of the first sacral vertebra (S1) with~     lidocaine and control with distilled water. The patients that present more than 50% of pain~     improvement, evaluated by the Likert scale after 30 minutes will form the study group, while~     the patients that do not present pain improvement with lidocaine or that present pain~     improvement with distilled water will be excluded.~      The medial branch block consists of the insertion of a 90mm, 25-gauge needle through the~     skin with radioscopic control up to the medial branch topography. Infusion of 1ml of 2%~     lidocaine should be performed in each medial branch of the abovementioned vertebrae. Control~     is executed in the same manner yet with infusion of 1ml of distilled water.~      Through the use of the diagnostic block we will have 40 patients selected for the second~     phase of the study. Once defined the study group should be evaluated before the procedure~     through the Oswestry, Roland Morris, SF-36 and VAS questionnaires.~      In the second phase of the study the patients will be randomized. The random division into~     two groups will be performed through a computerized program of random numbers. The~     randomization result will be kept in matt sealed envelopes to guarantee secrecy of the~     allocation. The neurolysis procedure will be carried out in the first group, consisting of~     20 patients, and the placebo or sham procedure with the second group, also with 20 patients.~      The neurolysis procedure will be carried out under sterile conditions, with the patient~     lying prone and with the neurotome insertion sites anesthetized with 2ml of 1% lidocaine.~     The neurotome (Smith & Nephew - RF) will be used for the procedure. The neurotome is a~     radiofrequency apparatus mounted on a 10cm electrode type 22 needle with a 5mm exposure tip.~     The neurotome should be introduced percutaneously in a manner similar to that adopted in the~     medial branch block through radioscopic control. The temperature of the electrode after its~     placement in the correct position is then raised to 80 °C for 90 seconds. Two neurotomies~     should be performed for each facet, one proximally and the other distally, due to double~     innervation of each facet. In the patients of the placebo group the procedure will be the~     same only the temperature of the neurotome will not be raised. This will be performed in a~     blind manner, as before starting the procedure, the surgeon will show the assistant who~     turns the device on or not the envelope containing the patient's group (placebo or~     neurotomy), yet the surgeon will not be informed whether the device has been turned on or~     not, having to perform the procedure in the same manner in both groups.~      The patients will then be reevaluated in the first month, 3 months after, 6 months after and~     12 months after the procedure. The assessors will not be informed of the group to which the~     patient belongs, and the same scales performed in the preoperative period will be used here.~   "
142454|NCT01190020|"~     Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic~     constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether~     Lubiprostone has effects on colonic methanogenesis is not known. The investigators~     hypothesize that the effects of Lubiprostone may in part be due to its effects on altering~     colonic flora, particularly methanogenic flora.~      By altering the colonic stasis of stool and through more efficient clearance of digestive~     residue, the investigators anticipate that Lubiprostone may either inhibit or promote better~     excretion of methanogenic flora, and thereby decrease the gut load of methane producing~     bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an~     increased rate of spontaneous bowel movements and reduction of constipation symptoms.~      The aim is to investigate the effects of Lubiprostone on intestinal methane production and~     bowel symptoms in patients with chronic constipation, by performing a randomized, double~     blind, placebo controlled study.~   "
142455|NCT01190007|"~     The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5~     mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period~     in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina~     pectoris and hypercholesterolemia.~   "
142456|NCT01189994|"~     Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep~     disturbances and depression. It affects population at a socioeconomically active age and~     represents a burden for the patients and the health care system due to its personal and~     functional implications. At this moment, there is no completely effective treatment for~     fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate~     if addition of acupuncture to standard care represents an improvement in comparison with~     standard care only. Thus, patients enrolled in this trial will be randomly allocated into~     one of two groups: group A, who besides standard treatment will receive 12 sessions of~     acupuncture; and group B, who will receive standard care with monthly orientation sessions~     for the same period. Patients will be evaluated at baseline, after completion of acupuncture~     treatment or orientation, and after an additional 12-week follow up. Evaluation will be~     based on diaries of pain and medication, and standard scales of pain, quality of life and~     disability.~   "
142463|NCT01189903|"~     1. Primary Endpoints~             -  Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF-~               MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of~               angiogenesis.~             -  Evaluation of potential relationships between biomarker data and clinical~               activity.~             -  Evaluation of a novel biomarker technology (Prometheus COPIA platform)~        2. Secondary Endpoints~             -  Biomarker data suggestive of regorafenib-mediated effects on circulating rare~               cells.~             -  Comparison of tumor genetic profiles obtained using DNA isolated from plasma,~               tumor biopsies and circulating tumor cells.~             -  Patient safety data~             -  Pharmacokinetics of regorafenib~             -  Changes in tumor metabolic activity as measured by PET CT scan (optional)~   "
142457|NCT01189981|"~     All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD)~     due to genetic end environmental causes. Advanced treatment and care has enhanced survival~     substantially, and adults with CHD are a growing population requiring continuous monitoring~     and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD)~     in young adulthood amongst other co-morbidities.~      It is known that adolescents with CHD are not as physical fit (PF) as their cardiac~     capability allows, most likely for reasons concerning safety, ability plus inactive everyday~     life. However, in 2006 The European Society of Cardiology states, that regular exercise at~     recommended levels can be performed and should be encouraged in all patients with CHD.~     Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few,~     as most adolescents' find it impossible to fit into everyday life.~      It is the investigators hypothesis that an eHealth intervention, to facilitate intensive~     exercise in the patients' neighbourhood environs, may improve physical fitness more~     efficiently than standard lifestyle education.~      The purpose of the study is to create evidence to recommend an efficient, fun and safe~     cardiac rehabilitation programme to adolescents with CHD.~      Primary outcome measure~      Cardiopulmonary exercise capacity: Online V02 max bicycle test~      Secondary outcome measure~      Level of physical exercise: Actigraph and Questionnaire~      Tertiary outcome measure~      Quality of Life: PedsQl~      Prevail is a national prospective, randomized clinical trial including 216 adolescents aged~     13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients~     included are all recommended to be as physical active as their healthy peers and pursue the~     principle guideline from The National Board of Health: All children and young people must~     be physically active for at least 60 minutes a day, preferably longer. Patients with mental~     retardation and FEV1 at baseline < 80% of predicted are excluded.~      The risk of participating in the purposed trial is not regarded as higher than everyday~     daily living.~      Results will be interpreted according to affiliation to health related fitness clusters.~   "
142458|NCT01189968|"~     The purpose of this study is to test the safety and determine the optimal dose of a new~     drug, demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a~     standard drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC).~     Participants must not have received prior chemotherapy for their NSCLC. Demcizumab is a~     humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer~     stem cells. The way the body handles demcizumab will also be investigated.~      Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain.~     Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your~     eligibility to take part in this study, and then if enrolled in the study you will receive~     intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed~     administered on the same day, every 21 days for 4 cycles, or until it has been shown that~     your cancer has progressed. If your physician decides to delay treatment with one of the~     agents due to side effects, the other agents may still be administered as scheduled. After 4~     cycles, if you have stable or improved disease, you will continue to receive pemetrexed once~     every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to~     determine the status of your disease.~   "
142459|NCT01189955|"~     Consecutive patients treated for thyroid enlargement at our institution were evaluated for~     inclusion. Participants were randomly allocated to receive total thyroidectomy using~     harmonic scalpel HS or using ligature conventional thyroidectomy CT Follow-up visits were~     after 1 week, 1 month, and 6 months, Study variables included operative time, length of~     incision, operative bleeding, postoperative drainage, hospital stay and complication.~      one hundred and thirty patients with thyroid enlargement were randomized and completed the~     study.~   "
142460|NCT01189942|"~     The purpose of this study is to test the safety and determine the optimal dose of a new~     drug, OMP-21M18, when given in combination with FOLFIRI, a standard drug treatment for~     advanced colorectal cancer. Participants must not have had more than one chemotherapy~     regimen for their metastatic disease. OMP-21M18 is a humanized monoclonal antibody (a~     protein made in the laboratory) developed to target cancer stem cells. The way the body~     handles OMP-21M18 will also be investigated.~      Up to 32 participants, 21 years or older, at up to 6 centres in Australia and New Zealand,~     will receive intravenous infusions of OMP-21M18 followed by FOLFIRI every two weeks, until~     disease progression or limited by drug toxicity. After 8 weeks, participants will undergo~     assessments to determine their disease status. If there is no evidence of disease~     progression participants will continue to receive infusions of OMP-21M18 and FOLFIRI every~     second week, until disease progression.~   "
142461|NCT01189929|"~     The purpose of this study is to test the safety and determine the optimal dose of a new~     experimental drug, demcizumab (OMP-21M18), when given in combination with gemcitabine with~     or without (+/-) Abraxane®. Historically, single agent gemcitabine has been the standard~     treatment for pancreatic cancer. However, recent data suggests that gemcitabine plus~     Abraxane® may be superior to gemcitabine alone, thus this combination is emerging as the new~     standard therapy for pancreatic cancer. However, Abraxane® has not been approved for the~     treatment of pancreatic cancer at this time. Demcizumab is a humanized monoclonal antibody~     and was developed to target cancer stem cells. This study is sponsored by OncoMed~     Pharmaceuticals, which is referred to as OncoMed or the Sponsor in this consent form. The~     study is designed to test the safety of demcizumab at different dose levels when given with~     gemcitabine +/- Abraxane® and the effects, both good and bad, that it has on participants.~     Demcizumab may block the growth of cancer stem cells, the remaining tumor cells, and it may~     also prevent the growth of new blood vessels that tumors need to grow and spread. Although~     demcizumab has been administered with gemcitabine to cancer patients, it has not been given~     in combination with gemcitabine and Abraxane®; thus, it is not known if it will provide any~     benefit to participants and may cause harmful side effects.~   "
142462|NCT01189916|"~     Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of~     minimally invasive surgery. NOTES is currently performed through transgastric or~     transvaginal approaches. The transvaginal approach is technically easier, but is only~     available to women. A transrectal approach has been proposed as a potential alternative to~     transvaginal NOTES for men. Fortunately, the technology to facilitate transrectal access and~     closure for NOTES has been in use for over twenty years, in the form of transanal endoscopic~     microsurgery (TEM) platforms.~      We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible~     endoscope and a TEM platform to assist with transrectal access and closure. After a~     pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal~     NOTES appendectomies in patients already scheduled to undergo laparoscopic total~     proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure~     will be removed as part of the patient's originally scheduled operation, reducing the risk~     of morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We~     will measure operative times, complication rates, peritoneal contamination, and assess the~     integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is~     clinically feasible in humans using a TEM platform.~   "
142464|NCT01189890|"~     The primary objectives of this study are to determine if sitagliptin treatment is not~     inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C)~     after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of~     symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if~     sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma~     glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will~     be randomized to either sitagliptin or glimepiride treatment after eligibility for study~     participation is determined during screening and washout study phases. Participants and~     study staff will not know to which treatment group they have been randomized (double-blind~     design). The duration of study participation will be up to 40 weeks (with 9 clinic visits).~     This will include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week~     (Visits 2 to 3) oral antihyperglycemic agent (AHA) wash-out phase (for those who have been~     taking a AHA prior to the study); a placebo run-in phase (Visits 3 to 4), followed by up to~     30 weeks of treatment with study medication.~   "
142465|NCT01189877|"~     The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or~     hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen~     supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells~     that are oxygen-starved respond differently to treatment such as chemotherapy and radiation~     when compared to cells that are oxygen rich.~   "
142466|NCT01189864|"~     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and~     biochemical stability of the cornea by inducing additional cross-links within or between~     collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this~     study is to generate data for presentation at medical meetings and for peer-review~     publication. The data generated by this study will not be submitted to the FDA to support~     commercialization of these riboflavin drops.~   "
142467|NCT01189851|"~     Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local~     Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral~     axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to~     evaluate the extent of disease.~   "
142468|NCT01189838|"~     Cysteine-rich 61 (Cyr61), a member of CCN family, regulates cell migration, proliferation,~     apoptosis, and angiogenesis, cell adhesion, migration, proliferation, survival,~     differentiation, apoptosis, angiogenesis, and extracellular matrix production. Evidences~     show strong correlations of aberrant Cyr61 expression in cancers of numerous organs and~     tissues. However, the expression and effect of Cyr61 in transitional cell carcinoma (TCC),~     the most common urinary tract cancer in Taiwan, remains undiscovered. Based on previous~     studies of Cyr61 in other cancer, the investigators hypothesize that Cyr61 may mediate TCC~     cell proliferation and migration; and associated with disease progression and recurrent.~     Thus the investigators conduct this project to study the role of Cyr61 in the pathogenesis~     of TCC. The investigators will retrospectively review medical history of patients with TCC~     treated at our institutes. Cyr61 immunohistochemical stain of their surgical samples will be~     performed. The correlation of Cyr61 expression of TCC and patients' clinical courses will be~     investigated.~   "
142469|NCT01189825|"~     The major aim of the this study is to replicate findings of previous research that examined~     the effects of acute exercise on sexual arousal in women in a novel population, namely,~     women taking antidepressants of the selective serotonin reuptake inhibitors (SSRI) or~     selective serotonin and norepinephrine reuptake inhibitors (SNRI) class. In previous studies~     it has been found that acute, moderate-intensity exercise facilitated physiological sexual~     arousal responses in healthy, sexually functional women. However, it is known that~     antidepressants may induce sexual dysfunction, and thus in the present study, the~     investigators are examining whether acute exercise may facilitate sexual responses in women~     with taking antidepressants, including women with antidepressant-related sexual dysfunction.~   "
142470|NCT01189812|"~     The investigators hypothesize that patients receiving citalopram in combination with lithium~     will have a greater reduction in depressive symptoms than patients receiving citalopram in~     combination with placebo.~   "
142471|NCT01189799|"~     The primary objective of the study is to test the incremental efficacy and outcomes of an~     aftercare program of Cognitive Behavioral Therapy combined with motivational therapy~     (CBT-MT) relative to treatment as usual (TAU) in improving depression, substance use, and~     healthcare outcomes in a population with drug dependence and comorbid major depressive~     disorder (MDD). The investigators expect that among drug-dependent patients with comorbid~     MDD, CBT-MT will yield better clinical outcomes relative to TAU in reducing depressive~     symptoms and substance use and improving healthcare outcomes during treatment.~      Secondary Objectives:~        1. Test efficacy and outcomes of CBT-MT and TAU~        2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of~          participants,~        3. To evaluate the impact of cognitive functioning on treatment retention and outcomes,~          and~        4. To explore additional psychosocial, demographic, and diagnostic factors (e.g., age,~          gender, education level, motivation for change, social support) that may be associated~          with treatment outcome and retention in this high need population.~      This study will include approximately 80 participants randomized to either 12 weeks of~     motivational therapy or treatment as usual. Both treatments will meet once weekly for 60~     minutes. Participants will be recruited from the Adult Partial Hospitalization program at~     UCLA. During the active treatment phase, participants will attend clinic weekly for~     collection of data and urine specimens.~        1. For those randomly assigned to CBT-MT, they will meet with a therapist in a group~          format for 60-minute sessions once weekly.~           a. Each CBT-MT session will begin with 20 minutes of motivational therapy (MT),~          followed by 40 minutes of CBT content.~        2. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery~          Anonymous self-help group.~   "
142472|NCT01189786|"~     Participants are being asked to take part in this study because treatment of his or her~     disease requires a stem cell transplant. Stem cells or mother cells are the source of~     normal blood cells and lead to recovery of blood counts after bone marrow transplantation.~     Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother)~     for the participant and his or her disease does not permit enough time to identify another~     donor (like someone from a registry list that is not his or her relative) or another~     suitable donor has not been identified. However, a close relative of the patient has been~     identified whose stem cells are not a perfect match, but can be used.~      Alternatively, the patient may have already received a stem cell transplant but have~     evidence of mixed chimerism, which means some of the patient's own bone marrow cells are~     present, rather than all of the donor's cells. This may lead to an increased risk of the~     disease coming back. Or, the patient may have all donor cells but his or her bone marrow is~     not working very well, which may lead to frequent blood or platelet (cells that help in~     clotting blood) transfusions or infection.~      Regardless of the reason, it may be necessary to isolate stem cells from a haploidentical~     (half-match) donor in order to provide bone marrow function. Because the stem cells from the~     donor are only half-matched to the participant, the risk of graft-versus-host disease (GvHD)~     is very high. GvHD is a complication after transplant caused by donor T cells (graft) that~     attack the transplant recipient, and this complication can cause death after transplant.~     Thus, it is important that the donor's blood cells are treated to minimize cells that are~     most likely to attack the host's tissues. This is done by using a special device to capture~     the CD34+ stem cells from the donor's stem cell product prior to giving the cells to the~     host. This method minimizes the donor T cells, which are responsible for causing GvHD.~      Purpose: In an effort to lower the occurrences and severity of graft-versus-host disease in~     patients and to lower the rate of transplant failure, investigators would like to specially~     treat the donor's blood cells to minimize the cells that are most likely to attack the~     patient's tissues.~   "
142476|NCT01189734|"~     Many options are available for management of common bile duct stones. the most recent~     development in this field is single-session approach by one of two methods; laparoscopic~     common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study,~     the investigators prospectively compare these two methods for management of patients with~     preoperatively diagnosed common bile duct stones to settle the best option.~   "
142477|NCT01189721|"~     The investigators hypothesize that propofol infusion during surgery can affect the~     remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by~     a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von~     frey filament.~   "
142478|NCT01189708|"~     The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh~     as prevention of incisional hernia after elective open abdominal aortic aneurysm repair.~     According to the literature these patients have an increased risk for an incisional hernia.~     By the implantation of an artificial mesh into the abdominal wall during the first abdominal~     aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies~     incisional hernia rates as low as 0% have been achieved.~      Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized~     into two groups, one receiving an onlay mesh, the other conventional wound closure with~     sutures.~   "
142479|NCT01189695|"~     The objective of this study is to determine efficacy of ritonavir-boosted lopinavir~     monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed~     Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently~     received salvage protease-inhibitor (PI) based regimens.~   "
142480|NCT01189682|"~     Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine~     impregnated sponge has been proven to reduce the rate of major catheter related infections~     in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40%~     of cases before planned changes and the rate of unplanned dressing is significantly~     associated with the major catheter related infections.~      Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease~     the rate of major catheter related infection as compared to non impregnated dressings and to~     demonstrate that highly adhesive dressing decrease the rate of detached dressings.~      Secondary objectives:~        -  To demonstrate that the use of high performance dressing decrease the rate of unstuck~          dressing and the rate of catheter infections.~        -  To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).~        -  To calculate the cost saving of each dressings~   "
142481|NCT01189669|"~     This is a dietary intervention study designed to assess the impact of long chain (LC) n-3~     polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS).~     Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the~     adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary~     supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.~   "
142482|NCT01189656|"~     To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA~     vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next~     dosing regimen.~   "
142483|NCT01189643|"~     This study adds irinotecan, temozolomide and bevacizumab to the chemotherapy regimen~     currently used to treat Desmoplastic small round cell tumor (DSRCT). The investigators are~     doing this study to find out what effects, good and/or bad, the combination of irinotecan,~     temozolomide and bevacizumab has on the patient and the DSRCT cancer.~   "
142484|NCT01189630|"~     The Observational Study in the Real World of Implantable Electronic Cardiac Devices will~     enable the construction of an electronic database with local access to clinical information,~     which will collect and disseminate epidemiologic data on demography, cardiovascular~     mortality and morbidity, and potential risk factors for a selected group of patients. These~     clinical variables will be analyzed against the data, as based in the programming of devices~     and the diagnostics. Approved descriptive statistics and analyses will be made available via~     Internet. The study will describe statistical indexes on sub-groups representing more than~     10% of total of datasets.~      The study will be open to include any patient that had a Medtronic electronic device~     implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices~     implanted in the present and for devices to be implanted in patients in the future.~   "
142485|NCT01189617|"~     This is a one-week study designed to test the safety of an all-in-one body and personal~     lubricant product during in-home use.~   "
142486|NCT01189604|"~     Phase IIB study to find the optimal dose rate range of propofol to maintain~     minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal~     polypectomy.~   "
142487|NCT01189591|"~     Sleep deprivation can acutely reverse depressive symptoms in patients with major depression.~     Although underlying mechanisms of the antidepressant action in sleep deprivation are~     unclear, many of these observations can be explained by abnormal slow wave homeostasis. This~     study will test the prediction that selectively reducing slow waves during sleep (slow wave~     deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.~   "
142488|NCT01189578|"~     The purpose of this study is to compare individuals with cocaine dependence to recreational~     users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this~     comparison may help us better understand the transition from recreational to compulsive~     cocaine use.~   "
142489|NCT01189565|"~     The purpose of this study is to evaluate the incidence of low levels of oxygen as determined~     by standard pulse oximetry monitor in patients who have had total hip or knee~     replacement/revision.~   "
142490|NCT01189552|"~     The objective of the current study is to evaluate the effects of a brief, behavioral~     activation treatment for depression (the Life Enhancement Treatment for Substance Use; LET'S~     ACT) on long term outcomes of depression, substance use, and HIV risk behaviors.~   "
142491|NCT01189526|"~     This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison~     with macular laser photocoagulation as treatments for macular edema secondary to branch~     retinal vein occlusion.~      Characteristics of this study is as below~        1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs.~          macular laser photocoagulation)~        2. After 48 weeks follow up, functional change(visual acuity)and anatomical change~          (central retinal thickness) would be evaluated~   "
142493|NCT01189500|"~     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on~     the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy~     post-menopausal female subjects. This study will also evaluate the safety and tolerability~     of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female~     subjects.~   "
142494|NCT01189487|"~     Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the~     severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day~     has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical~     efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving~     ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.~   "
142495|NCT01189474|"~     Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands~     dysfunction .~      Its objective is to Collect information from patients and ophthalmologists specialized in~     ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.~      This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.~      Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two~     uses per day) and complete a questionnaire every two days during the first week and then~     once a week the next two weeks.~   "
142496|NCT01189461|"~     This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular~     edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic~     macular edema.~   "
142497|NCT01189448|"~     Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be~     transmitted from to her unborn child. This results in congenital toxoplasmosis, which may~     cause damage to the eyes and nervous system of the child. To date, no method has been proved~     effective to prevent this transmission. In France, spiramycin is usually prescribed to women~     who have toxoplasma seroconversion in pregnancy, however its efficacy has not been~     determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic~     drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the~     prevention of mother-to-child transmission.~      Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more~     effective than spiramycin to prevent congenital toxoplasmosis.~   "
142498|NCT01189435|"~     The purpose of this study is to measure the ability of erlotinib to effectively treat~     recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with~     erlotinib or gefitinib received in the post-surgical or post-radiation setting.~   "
142499|NCT01189422|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and~     pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively~     recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first~     signs and symptoms of disease to a physician prior to randomization.~   "
142500|NCT01189409|"~     This is a study to compare the efficacy and tolerability of two laxatives for treatment of~     opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency~     Pain and Symptom Management/Palliative Care clinics. Each participating patient will be~     randomly assigned to one of two treatment groups.~   "
142501|NCT01189396|"~     The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic~     profiles of A006, in comparison with those of an active control, Proventil®-HFA MDI, and a~     placebo control DPI, in escalating and cumulative-doses up to 1,440 mcg, eight (8) times of~     the proposed clinical dose.~   "
142502|NCT01189383|"~     The purpose of the study is to gather data on feasibility as well as immune and clinical~     efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or~     stage IV melanoma~   "
142503|NCT01189370|"~     The purpose of this study is to determine whether an increase in the dose of sorafenib when~     given over five instead of 7 days/week, will result in an improvement of the response rate~     (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib~     will control your cancer, without causing a significant increase in side effects.~   "
142504|NCT01189357|"~     During the period 1989-1999, a number of patients underwent a meniscal transplantation. A~     few transplants were not successful. These patients form the population of this study. They~     all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after~     the failure of the transplants The goal of this study is to evaluate their current medical~     condition, to perform a survival analysis, and to determine the clinical outcome.~      The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS~     and SF-36)and clinical examination.~   "
142505|NCT01189344|"~     Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric~     acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due~     to low gastric dissolution has been reported in patients with atrophic or chronic gastritis.~     The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese~     patients before and after Roux-en-Y bariatric surgery.~   "
142506|NCT01189331|"~     Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical~     information about stenotic lesion,but the invasiveness and measuring difficulty of FFR make~     it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion~     severity and lately developing computational fluid dynamics could provide functional~     information. The investigators build a patient specific model of computational fluid~     dynamics by CT coronary angiography and evaluate the functional significance by measuring~     fractional flow reserve via CT coronary angiography and computational fluid dynamics.~   "
142507|NCT01189318|"~     In this study, patients with major depressive disorder (MDD) who have insomnia symptom are~     treated with Seroquel XR in an open-label manner for a 4-week period with repeated~     measurements of insomnia symptoms and sleep parameters using polysomnography.~   "
142508|NCT01189305|"~     In treating drug addiction, many studies of male patients show Behavioral Couples Therapy~     (BCT) helps the whole family (the drug abuser, the relationship partner, and their children)~     and is more effective than typical individual and group counseling. Only one study of BCT~     has been done with female drug-abusing patients, and results were promising but not~     definitive. The proposed study will test with married or cohabiting female drug-abusing~     patients whether BCT will produce more positive outcomes for the women, their male partners,~     and their children than standard individual counseling for the patient alone.~   "
142510|NCT01189279|"~     This study will investigate the safety, tolerability, and pharmacokinetics of new~     formulation of bimatoprost following topical application in patients with alopecia. Two~     formulations of bimatoprost will be investigated in Part 1 and a third formulation of~     bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.~   "
142511|NCT01189266|"~     This phase I/II trial studies the side effects and best dose of vorinostat and to see how~     well it works when given together with radiation therapy followed by maintenance therapy~     with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine~     glioma (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving vorinostat together with radiation therapy may kill more tumor cells.~   "
142512|NCT01189253|"~     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin,~     work in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. It is not yet known whether trabectedin is more effective than~     doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue~     sarcoma.~      PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared~     with doxorubicin hydrochloride and to see how well they work in treating patients with~     advanced or metastatic soft tissue sarcoma.~   "
142513|NCT01189240|"~     This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how~     well it works when given together with bevacizumab compared to bevacizumab alone in treating~     patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as bevacizumab, can block tumor growth in different ways. Some block the ability of~     tumor cells to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more~     tumor cells.~   "
142514|NCT01189227|"~     RATIONALE: Drugs used in chemotherapy work in different ways to kill tumor cells or stop~     them from growing. Giving combination chemotherapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving combination~     chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether~     giving combination chemotherapy before and after surgery is more effective than giving~     combination chemotherapy after surgery.~      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before~     and after surgery to see how well it works compared to giving combination chemotherapy after~     surgery in treating patients with colorectal cancer with liver metastases that could be~     removed by surgery.~   "
142515|NCT01189214|"~     Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12~     weeks after adjusted methadone dose. During the study, the investigators will evaluate~     treatment response and adverse effect from multiple dimensions to elucidate the therapeutic~     effect of add-on memantine on addictive behaviors. It will also explore the possible~     advantage of this treatment on social re-adaptation and psychopathogenesis of opioid~     dependence.~   "
142516|NCT01189201|"~     The primary objective of the current study is to investigate the relative bioavailability of~     BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)~     compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),~     both in the fasting state. All 42 subjects entered are planned to be included in this~     comparison.~      The secondary objective is to investigate the relative bioavailability of BI 10773 /~     linagliptin fixed dose combination tablet after administration of a standardised high fat,~     high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin~     fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the~     42 subjects entered 18 subjects are planned to be included in this comparison.~      An additional objective is to investigate the relative bioavailability of a second~     formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation~     A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet~     (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned~     to be included in this comparison.~   "
142517|NCT01189188|"~     The investigators aim to determine if ultrasound guidance results in improved technique when~     drawing blood via a radial artery puncture.~   "
142518|NCT01189175|"~     The objective of the study is to investigate whether ketoconazole affects plasma exposure of~     BI 113823~   "
142519|NCT01189162|"~     The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000~     g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post~     extubation may enjoy the comfort benefits associated with HFNC while getting coparable~     respiratory support to NIMV.~   "
142520|NCT01189149|"~     Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV)~     fluids in hospitalized infants with acute viral bronchiolitis.~   "
142521|NCT01189136|"~     If patients are unable to have their foley catheter removed because their bladder is not~     emptying well, they may be eligible for study participation. This study is designed to~     evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder~     function after surgery. Study participation is limited to one day.~   "
142522|NCT01189123|"~     This study is to study the immune response to the flu vaccine in people 65 years old and~     older. Only adults 65 years old and older and who are getting their flu vaccine are being~     asked to join in this study. The investigators plan to enroll approximately 100 people in~     this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease~     Control and Prevention on this study.~      There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained~     prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4~     tablespoons of blood drawn again. Patients will be randomized to receive either the standard~     dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.~   "
142547|NCT01188798|"~     The purpose of the study is to determine if participants who receive the GVHD prophylaxis~     medication pentostatin will have less severe hepatic toxicities than those receiving MTX.~     The study is estimated to have sufficient statistical power to ascertain at least a 20%~     improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin~     recipients.~   "
142523|NCT01189110|"~     Thirty three percent of our veterans currently smoke. Encouraging smoking cessation~     continues to be a top priority for the Veteran's Administration as smoking is the single~     most important preventable risk factor for mortality and morbidity. This study attempts to~     determine whether auriculotherapy may be used as an effective alternative to usual~     pharmacological interventions currently offered. Identifying an efficacious alternative~     method to nicotine patch or bupropion would be highly beneficial to veterans who want to~     quit smoking. This clinical trial took place at the Veterans Administration Medical Center,~     in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and~     female, age 19 or older, who smoked a minimum of 10 cigarettes per day, were evaluated for~     enrollment and randomized to two groups- true auriculotherapy and sham auriculotherapy in~     this 6 week trial.~   "
142524|NCT01189097|"~     The purpose of this study is to determine the pharmacological effects and outcomes of DM~     therapy with this add-on study.~      And to determine the immunological changes between the baseline and the end point of the~     study.~   "
142525|NCT01189084|"~     The purpose of this observational study is to determine whether the vaccine (UB 311),~     targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term~     immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's~     disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the~     target antigen based on supporting evidence of the hypothesis that places the accumulation~     of amyloid beta at the initiating step of AD.~   "
142526|NCT01189071|"~     This will be a randomized two arm prospective study to evaluate postoperative ureteral stent~     pain. One arm will be given 3 days of preoperative darifenacin and the control group will~     have the standard of care which is no preoperative anticholinergic medication. The primary~     endpoints will be decreased pain scores and less ER visits and hospital admissions for stent~     difficulty. These will be assessed by a pain diary completed by the participant as well as a~     questionnaire when the participant returns to clinic for stent removal. Also included in~     evaluation of the primary end point will be patient phone calls, ER visits and admissions~     for stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic~     use. This will also be assessed with the pain diary completed by the participant.~     Participants will be included in the study if they are undergoing a procedure that a stent~     will likely be required. This will include participants who will have ureteroscopy or~     extracorporeal shock wave lithotripsy and a stone 1 cm or larger. Also participants with~     stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent~     on preoperative evaluation will also be included in the study. Included as well in the study~     are participants who will undergo renal or ureteral surgery that a ureteral stent will be~     utilized. Participants will be randomized after consent is obtained into two groups. One~     group will receive standard of care which is no preoperative anticholinergic medications.~     The second group will receive the three day treatment with darifenacin pre procedure.~     Participants in the second group will be instructed on side effects of darifenacin and given~     appropriate contact information prior to initiation of the medication. Both groups will be~     followed postoperatively with a pain diary. Postoperative follow up will continue until the~     stent is removed 1-2 weeks after the procedure. The exact time of stent removal will depend~     on the success and nature of the surgery and will be at the discretion of the surgeon.~     Participants will be able to voluntarily stop the medication for any reason as well as if~     they have serious side effects from the medication. Data to be collected from each group~     includes age, gender, race, prior ureteral stents, prior renal or ureteral surgery, past~     medical history, allergies, current medications and urinary complaints.~   "
142527|NCT01189058|"~     Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects~     thousands of Canadian children and families. Treatments for CP are generally ineffective,~     and have traditionally focused on the weak body rather than the injured brain. Understanding~     how the newborn brain responds to injuries like stroke (plasticity) carries the greatest~     potential for better treatments. We propose to study the ability of two interventions to~     modulate brain plasticity toward better function in children with stroke-induced CP. One is~     a rehabilitation method called constraint-induced movement therapy (CIMT), the other is a~     type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS~     is safe and comfortable for children and we recently showed it could improve motor function~     in children with stroke.~      We will perform a special study to test both treatments simultaneously. Children 7-18 years~     with stroke-induced CP will be recruited into the study from across Alberta. Each child will~     randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending~     our new HemiKids Power Camp for motor learning. Improvements will be measured by trained~     therapists over 1 year. TMS will also measure brain plasticity, both initially and following~     treatment. Our lead investigator is an expert in both newborn stroke and TMS and has~     assembled an experienced team of accomplished collaborators to ensure the completion of this~     important work. This will be the largest study of children with CP examined in this manner.~     This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the~     largest trial of CIMT (and the first exclusive to newborn stroke), and the first study~     allowing the direct comparison of two different therapies. In establishing the first~     dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity~     changes in newborn stroke, advancing new treatments of this previously untreatable and~     disabling disease.~      Patient recruitment is currently underway at Alberta Children's Hospital. Application is~     currently underway to expand recruitment to Northern Alberta through the Glenrose~     Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern~     Alberta greater opportunity to participate as subjects in this study.~   "
142528|NCT01189045|"~     Little is known about how exercise can affect heart function in stroke survivors.~      This study will look at changes in cardiovascular fitness and function after 6 months of~     exercise. Volunteers will be tested before and after the program and again 2 months later to~     measure the effects on stroke risk factors, fitness level and flexibility of the arteries.~     Blood tests will measure cholesterol levels and other signs of inflammation.~      This study will help us better understand how exercise after stroke can improve heart~     function and heart health, and ultimately help in lowering future stroke risk.~   "
142529|NCT01189032|"~     Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in~     patients with dry eye, using a multicenter, randomized, double-blind, parallel group~     comparison study, and the optimal concentration is determined.~   "
142530|NCT01189019|"~     In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are~     collecting groups of patients who either do not or only partially respond to anti-VEGF~     therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically~     for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive~     injections of ranibizumab or bevacizumab over the previous 12 months. The investigators~     hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in~     these patients.~   "
142531|NCT01189006|"~     These results suggest that the DA neuroprotection provided by DM in the inflammation-related~     neurodegenerative models is not mediated through the NMDA receptor.~   "
142532|NCT01188993|"~     The purpose of this study is to assess the concordance of therapeutic changes proposed after~     an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly~     the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).~   "
142533|NCT01188980|"~     The purpose of this study is to determine if early Barrett's specialized intestinal~     metaplasia can be detected by measuring early increased blood supply of the esophageal~     tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in~     real time.~   "
142534|NCT01188967|"~     The purpose of this research study is to find out if an investigational drug, GSK598809 can~     help people who have very recently quit smoking; the investigators want to find out if~     continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To~     relapse means you fall back into smoking again after quitting. The investigators also want~     to find out if GSK598809 is safe to take without causing too many side effects.~   "
142535|NCT01188954|"~     A seroma is a collection of fluid other than pus or blood which forms through the division~     of numerous lymphatic channels, which normally drain the interstitial space under the skin.~     These channels become disrupted during surgical procedure and lead to seroma formation. This~     collection of fluid causes pressure in the local area, patient discomfort, and provides~     unfortunately an excellent culture medium for bacteria. Seroma development has been~     previously described in femoral vessel groin cannulation dissections after surgery.~     Conventional therapy is limited to draining the fluid, sometimes more than once, until there~     is full resolution of the seroma. If fluid collection recurs at the surgical site,~     sclerosant therapy with agents such as doxycycline. Doxycycline has been found to be a cost~     effective agent used as a sclerosant, which belongs to tetracycline class of antibiotics.~     The investigators hypothesize that prophylactic use of doxycycline at the site of femoral~     cannulation will prevent or minimize the area of seroma formation as compared to standard~     care of patients. The aim is driven towards limiting patient discomfort and visits to the~     clinic and to improve clinical care.~   "
142536|NCT01188941|"~     The purpose of this study is to test the effects of a health system navigator intervention~     on rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among~     newly diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be~     approached in the outpatient department and enrolled prior to an HIV test. Subjects will~     then be randomized to the navigator arm or the standard of care arm. Subjects in the~     navigator arm will receive scheduled phone and short message service (SMS) contacts~     throughout the follow-up period to help guide them through the HIV and TB care pathways. The~     navigator will provide personalized support to help subjects overcome barriers they may face~     along the way.~   "
142537|NCT01188928|"~     The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g~     Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components~     when used individually as monotherapy in the topical suspension vehicle (betamethasone~     dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension~     vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis~     vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study.~     This comparison will ensure a more informed assessment of the benefit/risk ratio of~     Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while~     also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp~     regions of the body (trunk and/or limbs).~   "
142538|NCT01188915|"~     After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced~     by treatment, are the first cause of death.~      The investigators will estimate the risk to develop breast cancer in this population of~     women treated for hodgkin disease, and will propose women at high rish to participate in an~     intensive screening program based on an annual detection based on mammography, echography,~     and RMI.~   "
142539|NCT01188902|"~     The objectives of the proposed study are to assess the effect of walnut consumption on~     parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial~     function and blood pressure in healthy men and healthy postmenopausal women~   "
142540|NCT01188889|"~     Patients participating in this study will have a diagnosis of Chronic Myeloid Leukemia. This~     study will evaluate whether the addition of an investigational drug called RAD001 given~     together with Imatinib will better target leukemia stem cells, causing them to die. Stem~     cells are a small population of cells, existing primarily within the bone marrow, and are~     believed to be responsible for the ongoing risk of disease relapse.~   "
142541|NCT01188876|"~     Pralatrexate is a type of antifolate drug which means is restrains the production of folic~     acid in the body. Folic acids are used by tumors to increase tumor cell growth and division.~     It is believed that reducing folic acid will hinder the rapid division of tumor cells, their~     growth and production. Carboplatin is an FDA approved chemotherapy drug for ovarian,~     fallopian tube and primary peritoneal cancer. Some antifolate drugs are used with other~     chemotherapy drugs to enhance cancer-fighting characteristics. It is believed that the study~     drug pralatrexate may improve the anti-tumor effect of carboplatin. In this research study~     we are looking for the highest dose of pralatrexate that can be given safely in combination~     with carboplatin.~   "
142542|NCT01188863|"~     This protocol is intended to compare the effects of both a solid (tablet) and liquid oral~     dosage form of LX4211 in subjects with type 2 diabetes mellitus.~   "
142543|NCT01188850|"~     DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages~     over traditional vaccines such as live attenuated virus and recombinant protein-based~     vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators~     have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins~     of both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate~     vaccines via electroporation (EP) using the CELLECTRA constant current device to deliver a~     small electric charge following intramuscular (IM) injection, since animal studies have~     shown that this delivery method increases the immune response to our DNA vaccine leading to~     a decrease in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was~     given to subjects with a history of CIN 2 and 3 who had been previously treated by surgery.~     This study is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to~     determine the safety and immune response.~   "
142544|NCT01188837|"~     Common medical therapies for knee osteoarthritis are patient education, drug and physical~     therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery~     carry significant risk. Manipulative therapy for KOA gives pain relief and increased~     function. However, research suggests addition of manipulative and soft tissue therapy (to~     the entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may~     give a better outcome. Exercise therapy is considered an effective and standard care for~     KOA.~   "
142545|NCT01188824|"~     The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing~     down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with~     PAD in Taiwan.~   "
142546|NCT01188811|"~     The purpose of the study is to determine if lipoic acid can protect the brain and slow~     disability in secondary progressive multiple sclerosis.~   "
143111|NCT01181414|"~     The aim of the present study is to compare the response to cardiac resynchronization therapy~     (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF)~     depending on atrio ventricular junction (AVJ) is ablated or not.~   "
142548|NCT01188785|"~     Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable~     adenocarcinoma of the pancreas.~      The primary endpoint:~      To assess efficacy and local distribution of siRNA out of eight high dose siG12D LODERs in~     patients diagnosed with operable adenocarcinoma of the pancreas.~      The Secondary endpoint:~      Short term tolerability and safety assessment~      Phase I - This study is designed to investigate the safety of siG12D LODER (Local Drug~     EluteR) in patients diagnosed with adenocarcinoma of the pancreas.~      The primary endpoint:~      To asses efficacy of siG12D LODER and local distribution in non-operable patients by~     histopathology measurements, local distribution by RNA analysis.~      To define the dose-limiting toxicities (DLT)~      The Secondary endpoint~        1. To determine the recommended Phase II dose (RP2D)~        2. To define and maximum tolerated dose (MTD)~        3. In the event of surgery, assessment of siG12D LODER local distribution and efficacy~          will be based on histopathology measurements and RNA analysis.~        4. Progression free survival - only by long term follow-up~   "
142549|NCT01188772|"~     Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to~     receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated~     interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to~     an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV~     RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in~     a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA <~     lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks~     of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.~      Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir~     400 mg plus PEG+RBV for 12 weeks.~   "
142550|NCT01188759|"~     This study aims to compare the safety, tolerability, and efficacy of voriconazole and~     anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17~     years with invasive aspergillosis.~   "
142551|NCT01188746|"~     The purpose of this study is look at how treatments for ascites affect quality of life. Your~     quality of life is the ability for you to enjoy the normal things you do. Ascites~     (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is~     caused by cancer, also called malignancy.~      All people who participate in this study have ascites associated with cancer. Ascites can~     cause symptoms that make it difficult for the patient to do simple things. Patients with~     ascites often report:~      Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating.~     Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this~     catheter will relieve the symptoms of the ascites. The goal of the investigators study is to~     understand the quality of life before the procedure and after the procedure. Since the~     patient is having this procedure to make their symptoms better, the investigators want to~     hear from the patient of how the procedure has affected their quality of life.~   "
142552|NCT01188733|"~     Octreotide is used to control variceal bleeding. However, octreotide has to be given through~     the vein and is effective for less than two hours.~      In this study the investigators determined whether a long-acting preparation of octreotide~     (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal~     pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.~   "
142553|NCT01188720|"~     Preliminary findings from a trial in the investigators laboratory suggest that acute~     exercise may ameliorate deficits in sexual arousal associated with use of antidepressants.~     The goal of this project is to evaluate the real-world effectiveness of an exercise-based~     intervention for these side effects in a community-based sample. The investigators~     hypothesize that general exercise will help improve sexual functioning in women taking~     antidepressants, and that exercise immediately before sexual activity - that is, acute~     exercise - will have an additional beneficial effect above and beyond that of general~     exercise.~   "
142554|NCT01188707|"~     The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to~     assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with~     non-small cell lung cancer who are eligible for treatment with erlotinib.~   "
142555|NCT01188694|"~     Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a~     traumatic event and intense, persistent feelings of anxiety. There are several effective~     therapies for PTSD, but they are often time consuming. The investigators want to see if the~     investigators can shorten treatment time while keeping therapy effective by adding a~     medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific~     aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than~     placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those~     receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To~     examine whether medication plus psychotherapy helps with depression, trauma-related~     cognitions, and functioning.~   "
142556|NCT01188681|"~     The objective of the first part of the study is to determine a safe dose of TRU-016 that can~     be used in combination with bendamustine in patients with relapsed CLL. The objectives of~     the second part of the study are to compare the safety and efficacy of TRU-016 in~     combination with bendamustine to bendamustine alone in patients with relapsed CLL.~   "
142557|NCT01188668|"~     The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine~     Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to~     healthy adult subjects. This study will also evaluate the safety and tolerability of~     Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.~   "
142558|NCT01188655|"~     This observational study will be a documentation of the prescribing and administration~     practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real~     life setting.~   "
142559|NCT01188642|"~     Obesity is now becoming significantly prevalent of an environment characterized by easily~     available calorics foods combined with sedentary lifestyles. Moreover, it has been~     demonstrated that obesity is associated with metabolic complications such as disturbed~     adipocytokines, hormones secreted by adipose tissue. Given these observations, the purpose~     of this study is to assess the effects of a lifestyle intervention focused on various~     physical activities and nutrition education on adipocytokines hormones, in severely obese~     teenagers.~   "
142560|NCT01188629|"~     Interactive telephony technologies offer a potentially highly effective, patient-centered~     communication modality by guiding parents at home through interactive discussions that can~     gather information and actively reinforce recommendations and treatments. Interactive~     telephony systems are particularly well suited for use in vulnerable populations since~     access to the telephone is nearly universal, and the system does not rely on reading printed~     text. The investigators propose to develop and evaluate an integrated patient-centered~     health information system, the Personal Health Partner (PHP). The PHP will use fully~     automated, interactive, conversations to gather personal health data and counsel parents~     before scheduled visits, exchange that data with the child's primary care clinician via the~     electronic health record (EHR), and offer personalized follow-up assessment and counseling~     after visits. The information technology-based approach to be evaluated in this project will~     link parents and children outside the clinical setting with their primary care center and~     will offer comprehensive assessments AND counseling to reinforce and support parental~     behavior change.~   "
142561|NCT01188616|"~     The goal of this exploratory/ developmental study is to develop and evaluate an integrated~     information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in~     overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT~     (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone~     conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with~     TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide~     children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3~     BMI points above the 95th percentile for age and gender, toward healthy weight management~     and assist the child's parent(s) and primary care provider (PCP) to support the child's~     efforts.~   "
142562|NCT01188603|"~     This trial examines the way flibanserin is metabolized in postmenopausal women with~     Hypoactive Sexual Desire Disorder.~   "
142563|NCT01188590|"~     The purpose for the investigators study is to investigate the severity and incidence of~     respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an~     adjunct to the current standard of care for early detection of inadequate ventilation in~     post-operative surgical in-patients undergoing cardiac surgery after discharge from~     intensive care unit (ICU) or post anesthesia recovery unit (PACU).~   "
142564|NCT01188577|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled~     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous~     epinephrine, in healthy male and female adult volunteers. The current study is designed for~     a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be~     evaluated, under augmented dose conditions.~   "
142565|NCT01188564|"~     This study is being conducted to confirm the efficacy, safety, and immunogenicity of~     recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of~     acute angioedema attacks in Hereditary Angioedema (HAE) patients.~   "
142566|NCT01188551|"~     This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following~     anesthesia induction in patients undergoing myringotomy and placement of pressure~     equalization (PE) tubes in providing analgesia and smoothing emergence from general~     anesthesia.~   "
142567|NCT01188538|"~     The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel~     (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl~     Peroxide 2.5% Gel.~   "
142568|NCT01188525|"~     The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug~     metabolism and their metabolites, after administration singly and simultaenously at~     predefined doses in 10 health volunteers.~   "
142569|NCT01188512|"~     The purpose of this study is to evaluate the safety and immunogenicity of a new live~     attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating,~     placebo-controlled study on a genetically modified B. pertussis strain given as a single~     intranasal dose to healthy adult male volunteers.~      Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most~     vulnerable age group), preferably after a single administration very early in life. The~     successful outcome of this project would constitute an important milestone towards nasal~     vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our~     ultimate aim is to protect infants in the most vulnerable age group, before the regular~     vaccination schedule using already available vaccines is applied. The ultimate aim is thus~     not to replace current vaccination schedules with available vaccines, but to add a first~     nasal vaccination to protect very early in life.~   "
142570|NCT01188499|"~     This is a dose escalation safety study of birinapant (TL32711) in combination with~     chemotherapy in subjects with advanced or metastatic solid tumors.~   "
142571|NCT01188486|"~     Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually~     causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment~     for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor~     operative candidates or decline surgery. An emerging alternative is Stereotactic Body~     Radiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRT~     offers excellent local control. Most SBRT trials focused on small, peripheral tumors in~     inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often~     with larger, central tumors.~      Using clinical staging, a significant proportion of patients harbor occult nodal metastases~     when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher~     risk of nodal metastases. These nodal metastases frequently would be removed by surgical~     intervention. However, SBRT, at present, is only directed at the primary tumor, potentially~     leading to regional failures in otherwise curable patients. To increase the effectiveness of~     SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of~     disease spread can be identified and targeted. Regional failure could be reduced and outcome~     improved in a significant proportion of patients treated with SBRT if the primary nodal~     drainage (PND) were identified, targeted and treated in addition to the primary tumor.~      We propose to conduct a study to determine how well water soluble iodinated contrast~     material when injected directly into the tumor can be visualized on CT scan and integrated~     into radiation therapy treatment planning.~   "
142572|NCT01188473|"~     Status asthmaticus is recognized as a common cause of morbidity in children in the United~     States. In recent years, hospitalization rates have reached an all time high. This study~     will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive~     Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe~     status asthmaticus.~   "
142573|NCT01188460|"~     This study will test the impact of a cognitive-behavioural self-management approach for the~     management of insomnia among patients with chronic pain. This self-management approach~     consists of a manual describing cognitive behavioural techniques for the management of~     insomnia. In terms of primary outcomes, it is anticipated that there would be improvements~     in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time~     awakenings in the sample group receiving a copy of the self-help manual intervention to be~     implemented by participants in their home (intervention group), relative to the group~     receiving treatment as usual (control group). In terms of secondary outcomes, it is~     anticipated that the intervention group will show improvements in mood, fatigue, pain~     severity, and pain-related disability relative to the control group. The tertiary outcome~     variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship~     with the sleep variables investigated.~   "
142574|NCT01188447|"~     The goal of this cohort study is to evaluate the safety and potential impact of an active~     strategy that allows paramedics to assess very low-risk trauma patients with the Canadian~     C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization.~     The specific objectives of the study are to determine safety, determine the clinical impact~     and evaluate performance.~   "
142575|NCT01188434|"~     This Research Plan proposes Stage 1 Research integrating evidence based practices to address~     the needs of mothers referred to child welfare for substance abuse. Mothers with a history~     of methamphetamine abuse and child neglect will be recruited. Using an intensive community~     based treatment, mothers will receive substance abuse treatment combined with parenting~     skills training and psychosocial support for basic needs (e.g., housing, employment). This~     project will include a feasibility study (n = 5), followed by a small randomized pilot (n =~     24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect~     compared to treatment as usual, with a population of substance abusing neglectful mothers~     referred through the Department of Child Welfare.~   "
142576|NCT01188421|"~     This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A~     randomized, double blind clinical trial comparing the efficacy and safety of tramadol to~     clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be~     conducted. Opioid dependent participants will be treated on a residential unit. The primary~     outcome measure is opioid withdrawal symptoms.~   "
142577|NCT01188408|"~     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.~     Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one~     of the most active agents in the treatment of metastatic castrate resistant prostate cancer~     (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be~     administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction.~     By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and~     comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from~     the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose~     to induce greater effectiveness of LE-DT. The current Phase II study is designed to~     accomplish the following objectives:~        1. Assess the antitumor effect indicator serum prostate specific antigen (PSA) following~          the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients~          with metastatic castrate resistant prostate cancer~        2. To evaluate the measurable soft tissue disease response using the response evaluation~          criteria in solid tumor (RECIST) methodology~        3. To evaluate the progression-free survival (PFS) and overall survival (OS)~        4. To correlate PSA expression with tumor response~        5. To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral~          neuropathy, water retention as well as myelotoxicity~        6. To evaluate the quality of life (QOL)~   "
142578|NCT01188395|"~     The aim of this study is to explore relation between the comorbidity of different bipolar~     disorders with alcoholism and neuropsychiatric function and candidate genes. The~     investigators plan to establish genetic validity for this subtype of alcoholism. In~     addition, by comparing this subtyped alcoholism to normal control, the investigators plan to~     examine the genetic validity of such comorbidity. The investigators plan to find specific~     clinical characteristic from neuropsychiatric aspects of such subtype for future early~     diagnosis, prediction and prevention.~   "
142579|NCT01188382|"~     Objective. The intracranial pressure and cerebrospinal outflow resistance are essential~     parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects~     intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the~     compliance of the system. The objective of this study was to determine the reference values~     in the elderly.~      Methods. Elderly people (60-82 years), considering themselves healthy, were recruited~     through an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance~     imaging apparatus. Subjects were eligible if they did not have any psychiatric or~     neurological disorder or signs of advanced atherosclerotic disease. Intracranial pressure~     and outflow resistance were determined by a constant pressure infusion method with the~     patient in the supine position. The study population consisted of 40 subjects (mean age 70~     years; 23 women).~   "
142580|NCT01188369|"~     This is a clinical, randomised, double-blinded study in which patients eligible for aortic~     valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo~     4 hours prior to surgery and until the end of surgery.~   "
142581|NCT01188356|"~     The purpose of this study is to evaluate the incidence and evolution over-time of~     co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2~     years follow-up.~   "
142594|NCT01188187|"~     This Phase 3 study has been designed to confirm that adding custirsen to standard first-line~     docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes~     compared to standard first-line docetaxel/prednisone treatment alone. This will be a~     randomized, open-label, multicenter, international trial. Treatment will consist of~     docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients~     will be randomized. Patients will be randomly assigned with equal probability to the two~     arms.~   "
142582|NCT01188343|"~     This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus~     vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at~     separate visits 6 weeks apart in toddlers aged 12 to 18 months.~      Primary objective:~        -  To demonstrate the non-inferiority of the antibody responses in terms of seroconversion~          of the concomitant administration of JE-CV and MMR compared to the antibody responses~          after the single administration of JE-CV and MMR vaccine.~      Secondary objectives:~        -  To describe the immune response to JE CV and MMR before and after one dose of JE CV and~          MMR vaccine, respectively.~        -  To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a~          6-week interval and the safety of the concomitant administration of JE-CV and MMR~          vaccine in all subjects up to 6 months after last vaccination.~   "
142583|NCT01188330|"~     Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of~     65. A poor outcome in this population has been well established, with very short overall~     survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors~     related to the disease itself or to the patient's medical condition.~      This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed~     at diagnosis with planned interventions according to disabilities and monthly follow-up by a~     nurse practitioner during 6 months on functional status of older cancer patients treated for~     Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental~     Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.~   "
142584|NCT01188317|"~     This randomized, double-blind, placebo-controlled, parallel group study will investigate the~     safety and tolerability, and the effect of aleglitazar in combination with ibuprofen on~     renal function, renin-angiotensin system and pharmacokinetics in healthy volunteers.~     Volunteers will be randomized to receive daily doses of aleglitazar or placebo in~     combination with ibuprofen. The anticipated time on study drug is 5 weeks.~   "
142585|NCT01188304|"~     This randomized, double-blind, placebo-controlled, parallel group study will investigate the~     safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal~     function, renin-angiotensin system and platelet aggregation in healthy volunteers.~     Volunteers will be randomized to receive daily doses of aleglitazar or placebo in~     combination with aspirin. The anticipated time on study drug is 5 weeks.~   "
142586|NCT01188291|"~     The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in~     eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography~     (OCT), and assess whether it is decreased. The investigators then compared the results with~     healthy subjects database of RNFL thickness from another retrospective study.~   "
142587|NCT01188278|"~     The purpose of this study is to determine predictive value of Hammersmith score on Complete~     Cytogenetic Response (CCyR).~   "
142588|NCT01188265|"~     Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and~     having protective effect against inflammation-related neuron damage. These anti-inflammatory~     and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of~     dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis~     was based on the findings that the mood stabilizers have been reported to be neuroprotective~     through the release of neurotrophic factors such as GDNF from astroglia. Thus, the~     combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic~     efficacy for bipolar disorder patients.~   "
142589|NCT01188252|"~     Clinical study to determine safety, tolerability, to measure how the drug is metabolized by~     the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent~     3 days on / 4 days off schedule to patients with advanced malignancies~   "
142590|NCT01188239|"~     The study's major aim is to investigate the ability of a commercial Electronic Nicotine~     Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking~     reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes~     in withdrawal symptoms and cravings and to examine whether concomitant use of the~     E-Cigarette and smoking is safe. The study will monitor smoking reduction/abstinence~     effects, changes in withdrawal symptoms, and adverse events of a currently marketed device~     in Italy (Categoria electronic cigarette) using initially for 6 weeks ORIGINAL 7.4 mg~     nicotine cartridges followed by a further 6 weeks of CATEGORIA 5.2 mg nicotine cartridges.~     The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe~     device that allows smoking reduction or abstinence in smokers possibly by suppressing~     withdrawal symptoms and cravings.~   "
142591|NCT01188226|"~     The majority of teeth utilized in the fabrication of conventional complete dentures are made~     of acrylic resins. These acrylic teeth provide increased bond strength to the denture base~     and are much easier to adjust for correct denture occlusion compared to teeth made of harder~     materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain~     teeth, leading to alterations in how the teeth contact each other if the denture is not~     replaced periodically (typically every 5-8 years). With the increase in biting and chewing~     forces that can be achieved during function with dentures supported by dental implants, the~     rate of tooth wear may be increased, leading to more frequent need for replacement of the~     prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer~     greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of~     fillers, including highly cross-linked organic macrofillers, high-density inorganic~     microfillers and silanized silica based nanofillers. The macrofillers are, to a large part,~     responsible for the adequate strength and color-stability of the teeth, whereas the~     microfillers improve the wear resistance. The nanofillers offer fundamentally different~     optical behaviour from those of larger fillers, improving light reflection without lowering~     the translucency. This offers additional opportunities in the development of composite~     teeth, which have to exhibit lifelike aesthetics and translucency. These teeth made of~     nano-particles and hybrid composites can be made with two different techniques, one where~     the materials are pressed together and another using an injection technique. The injection~     method has been found to have better aesthetic results, but resistance to wear in clinical~     use has not been established.~      The purpose of this study is to evaluate the wear characteristics of new resin denture teeth~     (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous~     subjects will be enrolled who have completed implant placement for mandibular implant~     overdentures opposing a maxillary complete denture or implant overdenture, or patients that~     have previously received these dentures and are interested in having new dentures. Both~     maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid~     composite denture teeth. The wear of denture teeth will be evaluated using~     stereophotographic recordings at baseline, 6, 12, 18 and 24 months after denture treatment.~   "
142592|NCT01188213|"~     The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in~     treating patients with knee OA.~   "
142593|NCT01188200|"~     The purpose of this study is to demonstrate the efficacy of a nutritional formula in~     patients with type 2 diabetes.~   "
143136|NCT01181089|"~     This is a prospective, randomized, multicenter, dose escalation study to determine subject~     safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS~   "
142595|NCT01188174|"~     The present trial will establish a prospective sequential Allogeneic Stem Cell~     Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced~     Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to~     which future innovative strategies can be compared.~   "
142596|NCT01188161|"~     Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer~     for astronauts. The rotations will be in many directions and the speed will be at 90~     deg/sec. The effects of this rotation on the ability to stand upright will be measured.~   "
142597|NCT01188148|"~     All participants should fulfill the following criteria: aged between 18 and 65 years old,~     and of domestic Han descendants. Participants will be randomly assigned to either the (1)~     pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on~     memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo~     plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals~     (60-80 participants per group) will be recruited for this study. For each CBGT group,~     12-weekly sessions are scheduled according to patients' preference. The investigators will~     attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on~     neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of~     only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for~     each type of treatment and possible mechanisms will be examined regarding the~     pharmacotherapy and CBGT for bipolar disorder patients.~   "
142598|NCT01188135|"~     Antidepressants are the most frequently prescribed class of psycho¬tropic medications and~     the most common treatment for depression and anxiety disorders—yet patient adherence is poor~     and is widely viewed as contributing to reduced effectiveness. However,~     traditionally-delivered adherence promotion programs are complex, staff-intensive, and~     costly—barriers to wider adoption, implementation, and maintenance of these programs in~     real-world settings. Our aim is to carry out a trial of a low-cost, IT-enabled~     Antidepressants adherence program, specifically a direct-to-patient, automated telephone~     interactive voice recognition (IVR) intervention to boost patient Antidepressants~     persistence. We will conduct a randomized clinical trial enrolling at least 6,000 Kaiser~     Permanente NW Region health plan members ages 21 to 75, who had recently started on~     Antidepressants medications for depression and/or anxiety diagnoses. Participants will be~     randomized one of four arms;1. a no contact control arm, 2. a treatment as usual (TAU)~     control condition 3. to TAU plus the IVR automated telephone program and 4. a TAU plus the~     IVR automated telephone program plus receipt of psycho-education materials about~     antidepression medication use. Recruitment will continue for up to 18 months, with periodic~     participant-level follow-up assessment for the intervention participants for 40 weeks. The~     IVR intervention portion of the program will deliver reminder and/or tardy calls timed to~     projected Antidepressants refill dates. The intervention also optionally offers brief~     psycho-education, or transfer to a live pharmacist or the Kaiser mail refill pharmacy. The~     primary outcome will be the Estimated Level of Persistence with Therapy (continued us of~     Antidepressants medications). This will be based on prescription refill data abstracted from~     the Kaiser's electronic medical record (EMR). We hypothesize that participants in the IVR +~     psycho-education materials study arm will have a significantly higher rate of~     Antidepressants persistence than those in the TAU control condition ons only IRV call arms.~     We will also conduct cost-effectiveness analyses to assess the value-for-money (cost per~     depression free day gained, and cost per quality adjusted life year gained) of the IVR~     technology compared to TAU. Costs will include IVR development and implementation as well as~     EMR-derived healthcare utilization data (visits, medications, etc.), augmented with~     participant report of out-of-plan services.~   "
142599|NCT01188122|"~     Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system~     intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon~     dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff~     inflation will lead to a reduction of complication rate related to mechanical ventilation~     procedure.~      This study was design in order to evaluate the feasibility of using the AnapnoGuard system.~   "
142600|NCT01188109|"~     The purpose of this study is to investigate if the investigators can use a specific marker~     in the pancreatic tumor itself to determine which patients will benefit from receiving~     combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a~     pancreatic cancer.~      The investigators will also investigate if there is any benefit to receiving both~     chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the~     tumor.~   "
142601|NCT01188096|"~     This study is for patients up to 21 years of age who have a tumor called a low grade glioma~     of the central nervous system (brain and spinal cord). The tumor has grown despite attempts~     to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that~     tend to grow slowly and could be cured if every bit of the tumor were surgically removed.~     These tumors are called Grade I or II astrocytomas.~      These tumors often grow in parts of the brain that prevent total removal without devastating~     neurologic complications or death. Although some low grade gliomas never grow, most will and~     are treated with either chemotherapy or radiation. There is good data showing that the~     growth of most low grade gliomas can be controlled with chemotherapy or radiation. However,~     some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC~     is a new drug that has been used safely in children and adults with different types of brain~     tumors. Earlier studies showed that this drug worked better for children and young adults~     with low grade gliomas than for children with more aggressive brain tumors. The main purpose~     of this study is to use Poly-ICLC treatment in a larger number of patients to see how well~     it works and how many side effects occur.~      As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held~     by Oncovir.~      Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments~     will be given in the clinic so allergic or other severe reactions, if any, can be monitored.~     If subjects tolerate the injections and don't have a severe reaction, then the rest of the~     injections will be given at home. Subjects/caregivers will be trained to give injections.~      Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2~     years if their tumor shrinks in response to the injections, if study doctors think it is~     safe, if subjects want to remain on treatment, and if Poly-ICLC is available.~      Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study,~     and at higher doses. Frequently seen side effects include irritation of the skin at the~     injection site and mild flu-like symptoms. These are usually relieved or avoided by use of~     over-the-counter medicines like acetaminophen (Tylenol).~      Funding Source: FDA OOPD~   "
142602|NCT01188083|"~     Primary Objectives:~        1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic~          steatosis in overweight children who have a baseline high fructose consumption and~          hepatic steatosis.~        2. To determine if a 4 week reduction of dietary fructose improves fasting plasma~          triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as~          well as post-prandial levels in response to a high fructose meal.~        3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative~          stress.~      Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose~     beverages administered over 4 weeks.~   "
142644|NCT01187537|"~     The purpose of this study is to compare the effectiveness of three analgesia techniques on~     pain relief and functional recovery after knee replacement: continuous femoral nerve block~     vs single-injection femoral nerve block with intravenous patient controlled analgesia vs~     intravenous patient controlled analgesia.~   "
142756|NCT01186081|"~     Based on the potential advantaged of preoperative chemoradiotherapy and oral~     fluoropyrimidine, the investigators planned a prospective randomized phase III trial which~     compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with~     conventional radiation schedule and oral fluoropyrimidine to establish new standard~     neo-adjuvant therapy regimen in locally advanced rectal cancer.~   "
142603|NCT01188070|"~     More and more family members are providing care to their loved ones with prolonged and~     progressive illnesses. Chronic intense caregiving represents a situation of chronic stress,~     which takes a toll on one's mental and physical health including an increased risk for the~     development or worsening of heart disease. Identification of effective self-care~     interventions for family caregivers is warranted to improve their emotional wellbeing and~     minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims~     to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with~     chronic illness. In two studies the investigators will test two interventions,~     psycho-education(ED) and physical exercise(EX), individually and in combination. The first~     study will target FCG of African American dementia patients; the second will focus on FCG of~     heart failure patients. Parallel designs, interventions and measures will create synergy as~     will integration of all data management and analyses within a Bio-behavioral Science and~     Measures Core. This Core will also provide high level guidance and interpretation of model~     testing resulting from analysis of the common data set. The combined de-identified data set~     will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk,~     further developing the model, and stimulating future research, while the shared core support~     will provide substantial efficiency; neither could be achieved outside of a Program Project~     approach. These collective efforts will generate important data whereby future care can~     significantly enhance the lives of FCG and minimize their risk of cardiovascular disease,~     the number one cause of disability and death in the United States.~      We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better~     psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver~     burden and higher levels of flourishing), behavioral outcomes (improved sleep quality and~     greater physical function), cardiovascular risk measures (improved resting heart rate, blood~     pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory~     markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved~     function, muscle strength, and endurance) compared to psycho-education and usual~     care-attention control from baseline to six months later mediated by improvements in process~     outcomes (lower perceived stress and higher self-efficacy).~   "
142604|NCT01188057|"~     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam~     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2~     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs~     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult~     volunteers administered under non-fasting conditions.~   "
142605|NCT01188044|"~     One way to assess impacts of nutrition supplements to health is to measure physical~     activity. Physical activity can be measured with small devices called accelerometers.~     Before they can be used, the devices need to be validated in the population in question.~     Objectives of this study are to test accelerometers in field conditions and validate their~     use in 16-18 months old Malawian toddlers. This study does not have a pre-set hypothesis.~   "
142606|NCT01188031|"~     This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam~     Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2~     mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs~     Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult~     volunteers administered under fasting conditions.~   "
142607|NCT01188018|"~     The purpose of this study is to determine, among a sample of general adult smokers, the~     effectiveness of three different counseling interventions for motivating quit attempts among~     smokers not yet ready to quit.~   "
142608|NCT01188005|"~     Obstructive Sleep Apnea Syndrome (OSAS) is associated with elevated plasma levels of IL-6~     and TNF-α, which cannot be accounted for by obesity (Vgontzas et al Sleep Med Rev~     2005;9:211-24, Ciftci et al Cytokine 2004;28:87-91].~      Obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before~     the ensuing arousals and re-establishment of airway patency. We have shown that strenuous~     diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of~     IL-6, TNF-α, and IL-1β (Vassi-lakopoulos et al AJRCCM 2002;166:1572-8) with concomitant~     up-regulation of the cytokines within the diaphragmatic myofibers (Vassilakopoulos et al~     AJRCCM 2004;170:154-61).~      OSAS patients exhibit frequent episodes of hypoxemia during the night. Loaded breathing is a~     form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an~     augmented plasma IL-6 response to exercise compared to normoxia (Lundby et al Eur J Appl~     Physiol 2004;91:88-93).~      In OSAS, monocytes have oxidative stress (Dyugovskaya et al AJRCCM 2002;165:934-9) and~     produce more cytokines (TNF-α) in vitro (Minoguchi et al Chest 204;126:1473-9).~      Hypothesis #1: plasma levels of IL-6 and TNF-α are increased during the night in OSAS~     patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes~     of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas.~      Hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular~     expression of IL-6 and TNF-α during the night.~      Hypothesis #3: Oxidative stress is a stimulus for cytokine upregulation in OSAS.~   "
142609|NCT01187992|"~     This study was designed to test the hypothesis that the addition of full-dose atorvastatin~     (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after~     non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse~     coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.~   "
142610|NCT01187979|"~     The purpose of this study is to assess the impact of a cash-incentivised prevention~     intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.~   "
142611|NCT01187966|"~     The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide~     (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with~     idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable~     dose of levodopa.~   "
142612|NCT01187953|"~     This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets~     administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as~     immunosuppression for the prevention of organ rejection in newly transplanted adult kidney~     transplant recipients. Patients will be treated for a 12 month study period followed by a 12~     month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically~     similar to Prograf Capsules in the prevention of acute rejection.~   "
142655|NCT01187394|"~     In Canada, 218,000 units of fresh frozen plasma and frozen plasma were transfused in~     2005.Cardiac surgery patients are the largest recipient group for FP transfusions. Despite~     this, no studies have characterized the use of FP in relation to coagulation test~     abnormalities or bleeding, or how these and other clinical determinants influence the~     decision to transfuse FP. Furthermore, no studies have evaluated the effectiveness of FP~     transfusions in correcting laboratory abnormalities or treating bleeding in cardiac surgery.~      Given the varied use of FP transfusions in cardiac surgery, further studies are essential.In~     order to improve current utilization of FP, current use must be understood, and the~     relationship between FP transfusions and the clinical factors that affect the decision to~     transfuse FP.~   "
142613|NCT01187940|"~     When a clinician gives an autism spectrum disorder (ASD) diagnosis they hope this will be~     helpful to the person receiving it and their family. In reality children with an ASD~     describe few benefits to receiving this diagnosis - they often report feeling confused and~     stigmatised by it. Parents can also struggle to understand their child's diagnosis and~     report needing greater support from professionals in this respect (Midence & O'neill, 1999;~     Osborne & Reed, 2008).~      Little is known about how to help children and families integrate their ASC 'label' in a~     positive way. Whilst there is anecdotal evidence that psychoeducation after diagnosis can~     help, there has been no formal evaluation of this approach and no evidence-based programmes~     of this type are available. In the current study the investigators aim to test empirically a~     psychoeducational programme for children with an ASD ('PEGASUS'), using a randomised~     controlled design. The investigators aim to evaluate whether this psychological and~     educational intervention impacts positively upon understanding of ASC, self-esteem,~     functional adaption, well-being and family functioning.~   "
142614|NCT01187927|"~     This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in~     Japanese female subjects under conditions of actual use.~   "
142615|NCT01187914|"~     The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar~     formation in the left atrium of the heart. This will be assessed by delayed enhancement~     magnetic resonance imaging and will be looked at in patients who have undergone successful~     open irrigated cooled-tipped radio-frequency ablation of paroxysmal atrial fibrillation.~     Follow-up after ablation will be for 12 months.~   "
142616|NCT01187901|"~     The purpose of this study is to determine in a randomized, placebo-controlled, phase II~     trial if the combination of sulindac and erlotinib causes a significant regression of~     duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP~     (AFAP) patients.~   "
142617|NCT01187888|"~     The purpose of this study is to determine whether rasagiline is effective in the treatment~     of Progressive Supranuclear Palsy (PSP), a rapidly progressing disease with a symptomatology~     similar to Parkinson's Disease. The major aim of this study is the limitation or halting of~     the process of neurodegeneration and influence postural instability.~   "
142618|NCT01187875|"~     Dietary fiber consumption may contribute to weight regulation by improving satiety. In an~     earlier study the investigators found that a muffin containing resistant starch was more~     effective than other fibers in altering satiety. The objective of this study is to determine~     if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant~     starches is more effective than either alone in enhancing satiety.~   "
142619|NCT01187862|"~     The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called~     Basel cocktail) can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9,~     CYP2C19, CYP2D6, CYP2E1 and CYP3A4.~   "
142620|NCT01187849|"~     The purpose of this study is to evaluate if a treatment with metformin compared to placebo~     reduces metabolic side-effects in patients with glucocorticoid treatment over three months~     time.~   "
142621|NCT01187836|"~     In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with~     heart failure to learn about the effects of TRV120027. The results of this study will help~     choose the proper range of TRV120027 doses to use in future research studies involving~     patients with acute decompensated heart failure.~   "
142622|NCT01187823|"~     The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto~     SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central~     sleep apnea.~   "
142623|NCT01187810|"~     The purposee of this study is to determine the safety and dosing of Fenretinide when given~     continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or~     resistant acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and~     non-Hodgkin's lymphoma (NHL).~   "
142624|NCT01187797|"~     The purpose of this study is to evaluate the effects of a short-term emotional stimulation~     on the mood of healthy persons.~   "
142625|NCT01187784|"~     Many children and adolescents with autism spectrum disorder (ASD) experience high levels of~     anxiety which can further inhibit their ability to master developmental tasks such as~     succeeding in school and developing and maintaining friendships. Despite the need for~     effective treatments for children with ASD and anxiety, there have been few studies that~     have addressed this issue. Recently, preliminary evidence has supported the use of~     cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD.~      This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found~     to be one of the most effective treatments for typically developing children with anxiety~     and has also been shown to be effective for treating anxiety in children with other~     disorders such as physical impairments, selective mutism, and Attention Deficit~     Hyperactivity Disorder. The investigators goal is to demonstrate that Coping Cat is an~     effective treatment for children with ASD and anxiety. Finding effective treatments for~     children with ASD and anxiety could increase adaptive social relationships, decrease stress~     among families, and prevent the maintenance of anxiety into adulthood.~   "
142626|NCT01187771|"~     The purpose of this study is to assess the feasibility of conducting a comparative~     effectiveness study comparing a medical versus surgical approach to the initial management~     of obstructive sleep apnea (OSA) in the setting of obesity.~   "
142627|NCT01187758|"~     This study aims to implement judicious antibiotic prescription habits to primary care~     pediatricians using a multifacet educational intervention and assess two main outcomes: 1)~     Direct outcome - prescription rates of the physicians. 2)Indirect outcome - carriage of~     antibiotic resistant bacteria by the treated population, specifically nasopharyngeal S.~     pneumoniae, nasal S. aureus and rectal E.coli.~   "
142628|NCT01187745|"~     Patients suspected of having a kidney stone are usually evaluated by computed tomography~     (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to~     evaluate kidneys for suspected renal stones.~   "
142629|NCT01187732|"~     The purpose of this study is to compare the traditional bed bath with 'washing without~     water' on~        -  1) effects on skin integrity~        -  2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will~          randomize 50 nursing home wards (576 patients) to 'washing without water' or~          traditional bed baths. Bathing regimens are continued for six weeks.~      Whereas effects on skin damage are not likely to be specific for setting, these results can~     be generalized to other patient groups.~   "
142630|NCT01187719|"~     The primary objective of this two-phase trial is as follows:~        -  To determine the elimination half-life of NVP in HIV positive pregnant women receiving~          it as a single dose in labour in addition to the ZDV and 3TC with or without seven days~          phenytoin (pilot PK phase)~        -  To determine NVP resistance in HIV positive pregnant women receiving it as a single~          dose in labour in addition to ZDV and 3TC with or without seven days phenytoin (main~          trial phase)~      The secondary objectives of this two-phase trial are as follows:~        -  To determine the safety of single dose nevirapine with seven days phenytoin as a part~          of ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part~          of ARV prophylaxis for PMTCT~        -  To determine the HIV status of the infant~        -  To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin~          on the newborn~      Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases~     development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.~   "
142631|NCT01187706|"~     To compare quality of life and it's related factors between gynecological cancer survivor~     and healthy controls.~   "
142632|NCT01187693|"~     People with anatomical leg length discrepancy (LLD) commonly presented excessive subtalar~     pronation of the long leg compared to their short leg in order to equalize leg length.~     Although such compensation may decrease the stress in the pelvis and/or low back region, the~     pronated foot may lead to excessive stress loading onto the ankle or foot, resulting in~     musculoskeletal injuries. Clinically, the pronated foot has been effectively controlled~     using functional orthoses with proper posting by adjusting the subtalar joint in the neutral~     position. But for people with compensatory pronated foot resulted from anatomical LLD, to~     control excessive pronation of the long leg would exaggerate their asymmetry in leg length.~     Instead, the pronated foot can be controlled simply by adjusting the length of the short~     leg. However, there is limited evidence of such intervention in previous literature. The~     purpose of this research project is going to determine the effect of leg length adjustment~     on pronation control in people with anatomical LLD. According to this purpose, 5 study~     objectives will be developed: 1) to examine the validity and reliability of LLD measurement~     using a hand-held laser distance meter, 2) to compare the foot types before and after leg~     length adjustment, 3) to compare the kinetic variables before and after leg length~     adjustment during quiet stance, 4) to compare the kinetic variables before and after leg~     length adjustment during level walking, and 5) to compare symptoms and functional levels~     related to low back pain (LBP) before and after leg length adjustment.~      The present research project will be designed as a convenience sampling, prospective,~     quasi-experimental, and pretest/posttest design. There will be 2 parts in this research: 1)~     validity and reliability test of laser measure for leg length and 2) foot morphology and~     kinetic analysis before and after leg length adjustment. For the first part of this~     research, 10 male adults and 20 adults will be recruited for the validity and reliability~     tests respectively. Anthropometric measurements, including body height, body weight, foot~     length, foot width, and heel-ball distance, will be measured after a consent form is signed.~     Participants of the validity test will receive standing pelvic radiography and laser measure~     to measure their leg length. Each participant of the reliability test will receive 2~     sessions of laser measure using a hand-held laser-distance meter. For the first session, all~     laser measurements will be employed twice by 2 raters with a rest interval of more than 5~     min. One week later, another session of laser measure will be given again by one of these 2~     raters. Intraclass correlation coefficient (ICC) will be used to test the interrater~     reliability, intrarater reliability, and validity of the laser measure method. Standard~     error of measurement (SEM), and small real difference (SRD) will be calculated to~     represented intrarater reliability also. For the second part of the research, another thirty~     adults with compensatory pronated foot resulted from LLD will be included in the research~     project but the sample size will be adjusted to the appropriate number according to power~     analysis. Each participant will be asked to fill out the visual analog scale (VAS) and the~     Oswestry Disability Index (ODI) and receive tests containing foot type examination, quiet~     stance with eye opening, quiet stance with eye closed, and level walking. All tests will be~     performed before and after leg length adjustment. The experiment will be completed after~     collecting 3 successful trials for each test. All procedures will be done one month later.~     ANOVA with repeated measures will be calculated to compare the differences in these~     variables among before, immediately after, and 1 month following leg length adjustment when~     the data fit the assumptions of normal distribution. Discrete variables or variables with~     non-normal distribution were tested using the Friedman test. All statistical analyses will~     be calculated using SAS 9.1.3. The significant level was set at α = 0.05 while the power was~     at 0.8.~      Five possible results may be expected from conducting this research project: 1) there will~     be good validity and reliability of the laser distance meter to measure LLD, 2) there will~     be significant differences in measurements of foot type before and after leg length~     adjustment, 3) there will be significant differences in kinetic data during quiet stance~     before and after leg length adjustment, 4) there will be significant differences in kinetic~     data during level walking before and after leg length adjustment, and 5) symptom and~     functional level related to LBP will improve after leg length adjustment. Completion of this~     research project will be projected to provide solid and objective evidences for leg length~     adjustment through views of morphology and kinetics in people with pronated foot due to~     anatomical LLD.~   "
142633|NCT01187680|"~     The purpose of the study is to investigate whether sprayable PEG barrier is effective in~     reducing adhesions in laparoscopic gynecologic surgery.~   "
142634|NCT01187667|"~     Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance~     to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients~     with history of dementia or alcohol abuse)since the delirium protocol is changed and~     haloperidol is added as a prevention treatment we are gathering information what the effect~     is on several aspects of delirium~   "
142635|NCT01187654|"~     Although a percutaneous coronary intervention (PCI) can be used to open up the blocked~     artery and restore blood flow to the heart muscle after myocardial infarction, there may be~     a significant amount of heart tissue that has been irreversibly damaged. Recent studies have~     shown that adult stem cells from bone marrow may be able to improve heart function and~     prevent from heart remodeling due to heart failure.~      This study will evaluate the safety and effectiveness of using adult bone marrow derived~     stem cells for improving heart function in MI patients with Left Anterior Descending (LAD)~     involvement.~   "
142636|NCT01187641|"~     The purpose of this study is to determine whether MRI is more accurate than CT in~     determining the T stage, N stage, depth of tumour invasion and extra mural venous invasion~     (EMVI) preoperatively in colon cancer.~   "
142637|NCT01187628|"~     The objective of this study is to investigate the safety and the effect on reduction of~     serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250~     mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period~     of Study 14817 and are judged to be eligible for the long-term extension study.~   "
142638|NCT01187615|"~     This is a multi-center, open-label, non-randomized Phase I study to define the safety~     profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of~     regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or~     Stage IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the~     combined administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin.~      In Part A of this trial, regorafenib will be administered in a sequential dosing with a~     seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib~     will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break.~      In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21.~     Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the~     pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.~   "
142639|NCT01187602|"~     The purpose of this study is to create new tests to identify biomarkers for ovarian cancer~     so that a screening test can be developed. For patients who have a diagnosis of ovarian~     Cancer, researchers will use blood samples before and after treatment to see if disease~     status can be determined by measuring the amount of biomarker.~   "
142640|NCT01187589|"~     This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition~     of Aerosol and on Pulmonary Functions in COPD Patients~   "
142641|NCT01187576|"~     Background The present study protocol describes the trial design of a primary care~     intervention cohort study, which examines whether an extended, multi-professional physical~     activity referral (PAR) intervention is more effective in enhancing and maintaining~     self-reported physical activity than ordinary physical activity recommendations. The study~     targets patients with newly diagnosed hypertension and/or type 2 diabetes.~      Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose;~     physical fitness and anthropometric variables; mental health; health related quality of~     life; and cost-effectiveness. Methods/Design The study is designed as a long-term~     intervention. Three primary care centres are involved in the study, each constituting one of~     three treatment groups: 1) Intervention group (IG): multi-professional team intervention~     with PAR, lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health~     behaviours, lifestyle brochure; and 3) Control group B: treatment as usual (retrospective~     data collection).~      The intervention is based on self-determination theory and follows the principles of~     motivational interviewing. Physical activity is measured with the International Physical~     Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes~     per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables~     such as health behaviours; health-related quality of life; motivation to change; mental~     health; demographics and socioeconomic characteristics are assessed with an electronic study~     questionnaire that submits all data to a patient database, which automatically provides~     instant feed-back on the patients' health status.~      Cost-effectiveness of the intervention is evaluated continuously and the intermediate~      - 3 - outcomes of the intervention are extrapolated by economic modelling. The first~     statistical analyses and compilation of results will be performed one year after inclusion~     of the first patient or when the IG and CA have included 60 and 30 eligible patients~     respectively. Discussion By helping patients to overcome practical, social and cultural~     obstacles and increase their internal motivation for physical activity we aim to improve~     their physical health in a long-term perspective. The targeted patients belong to a patient~     category that is supposed to benefit from increased physical activity in terms of improved~     physiological values, mental status and quality of life, decreased risk of complications and~     maybe a decreased need of medication.~   "
142642|NCT01187563|"~     This is an open-label, uncontrolled, observational study in patients with rheumatoid~     arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of~     their standard of care.~   "
142643|NCT01187550|"~     This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV~     interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD)~     were treated for 4 weeks with Saizen to compare the response between GHD children born~     appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4~     weeks of Saizen therapy.~   "
142757|NCT01186068|"~     The purpose of this study is to evaluate the dose-response relationship (effect) of four~     concentrations of V-101 Cream in patients with erythematous(redness) rosacea.~   "
142645|NCT01187524|"~     Background:~        -  In human DNA, the Fragile X (FMR1) gene helps to regulate the nervous and reproductive~          systems. If the gene is abnormal, it can cause different kinds of problems, such as~          abnormal menstrual periods, decreased fertility, muscle tremors, and mental~          retardation. An abnormal FMR1 gene can also make a person more susceptible to other~          medical conditions, such as thyroid problems, high blood pressure, seizures, and~          depression. More research is needed on how abnormalities in the FMR1 gene can lead to~          these problems, and how often these problems appear in individuals with an abnormal~          FMR1 gene.~        -  Researchers are interested in developing a patient registry of women who have an~          abnormality in the FMR1 gene. This registry will allow researchers to follow~          participants over time and study possible effects of this abnormality on their general~          and reproductive health.~      Objectives:~      - To develop a patient registry of women with an abnormal FMR1 gene and monitor their~     general and reproductive health.~      Eligibility:~      - Women at least 18 years of age who have an abnormal FMR1 gene on the X chromosome.~      Design:~        -  The following groups of women will be eligible for screening for this study:~        -  Those who have a family member with Fragile X Syndrome or mental retardation~        -  Those who have (or have a family member who has) primary ovarian insufficiency, also~          known as premature menopause~        -  Those who have (or have a family member who has) certain neurological problems such as~          tremors or Parkinson's disease.~        -  Eligible participants will be scheduled for an initial study visit at the National~          Institutes of Health Clinical Center. Participants who have regular menstrual periods~          should schedule the visit between days 3 and 8 of the menstrual cycle; those who do not~          have regular periods may have the visit at any time of the month. In addition, all~          estrogen-based treatments (such as birth control pills) must be stopped for 2 weeks~          prior to the study visit.~        -  Participants will have a full physical examination, provide a medical history, and~          provide blood samples for immediate and future testing. Participants will return for~          yearly visits for the same tests for as long as the study continues.~        -  Participants who have or develop primary ovarian insufficiency related to the FMR1 gene~          will also have tests to measure bone thickness and will have a vaginal ultrasound to~          examine the ovaries. These tests will be scheduled for a separate visit, and will be~          repeated every 5 years for the duration of the study.~   "
142646|NCT01187511|"~     Objective:~      To evaluate GSK561679, an orally available, brain penetrant selective CRH1 antagonist for~     its ability to reduce alcohol craving in recently detoxified alcohol dependent women in~     response to stress or alcohol-associated stimuli.~      Study population:~      Up to 60 anxious, alcohol dependent women, aged 21-65 years will be enrolled to complete the~     study in 50 patients.~      Background:~        -  Anxiety, irritability, anger, and depression can all cause stress that may lead to~          continued drinking in heavy drinkers. One way the brain responds to stress is through a~          protein on brain cells called a CRH receptor. Previous research has shown that the CRH~          receptor is involved in negative emotional states and that chronic alcohol consumption~          increases the activity of CRH receptors in the brain. Medications that block CRH~          receptors can decrease stress-triggered alcohol consumption.~        -  GSK561679, an experimental drug that blocks the CRH receptors, can reduce negative~          emotions such as anxiety and a person s desire for alcohol. By looking at the brain s~          response to stress and the study drug using functional magnetic resonance imaging~          (fMRI) scans, researchers hope to learn whether GSK561679 can be an effective treatment~          for stress-related alcohol abuse.~      Objectives:~      - To evaluate the usefulness of GSK561679 in reducing stress-related alcohol craving in~     alcohol-dependent women.~      Design:~        -  Participants in the study will be enrolled in the standard NIH treatment program for~          alcohol dependence, and will be required to stay at the NIH inpatient treatment unit~          for an additional 31 days.~        -  Participants will receive either the study medication or a placebo to be taken once a~          day in the evening for 4 weeks.~        -  Participants will have the following procedures while on the study medication:~        -  Questionnaires about alcohol craving, depression, and anxiety.~        -  Recordings and responses to personal emotional reactions to stressful, nonstressful,~          and alcohol-related situations, with blood samples taken during the responses.~        -  Regular blood tests to measure stress hormones in the blood.~        -  Speech preparation and presentation (Trier test), along with blood samples, to measure~          stress hormones in the blood.~        -  Sessions to measure responses to alcohol-related cues.~        -  Functional magnetic resonance imaging (fMRI) scans.~        -  Participants will return for follow-up visits 1 week and 1 month after stopping the~          study drug and being discharged from the study.~   "
142647|NCT01187498|"~     The primary purpose of this project is to evaluate the effectiveness of behavioral treatment~     compared to standard drug therapy for symptoms of OAB in male veterans.~   "
142648|NCT01187485|"~     The purpose of this study is to see how safe Androderm® (the study drug) is at three~     different doses in subjects with early hormone refractory prostate cancer. In addition,~     information about hormonal levels and the effects of testosterone on quality of life~     including sexual functioning and muscle strength will be collected.~   "
142649|NCT01187472|"~     This protocol was opened to collect long term survival information on subjects enrolled in a~     previous study which evaluated the impact of neoadjuvant chemotherapy and concomitant~     chemoradiotherapy with organ preserving optional surgery on overall survival, time to~     progression, pattern of disease recurrence in patient with locally advanced head and neck~     cancer. The last surviving subject was last treated in 1989, and was lost to follow up in~     2010.~   "
142650|NCT01187459|"~     Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic~     relapsing inflammatory disorder of the digestive system. CD affects ~112,000 individuals in~     Canada, of whom 20-25% are diagnosed in childhood or adolescence. The specific cause of CD~     remains unknown; however, it is hypothesized that CD involves a complex interaction of~     several factors, including a genetically susceptible host, the intestinal mucosal immune~     system and microbe population. Several dietary factors have been explored for their~     potential role in the etiology of CD. However, no consensus on the role of diet has emerged.~     Recent evidence suggests a plausible link between a lack of Vitamin D and CD.~      Purpose & Hypothesis: The investigators primary hypothesis is that a greater proportion of~     pediatric CD patients will achieve optimal 25OHD concentration (> 75 nmol/L) on 2000 IU/d~     than 400 IU/d Vitamin D.~      Methods: Pediatric Crohn's Disease patients between 8-18 years of age, and have been in~     remission for at least 4 weeks as indicated by a Pediatric Crohn's Disease Activity Index~     (PCDAI) <10 will be recruited for a double-blind, randomized, controlled trial where they~     will receive one of two dosages of vitamin D (10 or 50 ug/day) and will be asked to continue~     the supplementation for 6 months. Vitamin D levels will be measured in blood at baseline, 3~     months, and 6 months. Dietary vitamin D intake will be estimated using a food frequency and~     lifestyle questionnaire. Data will be analyzed using multiple regression analysis~     controlling for baseline values.~      Expected Results and Conclusions: It is expected that a greater proportion of children~     receiving the 50 ug/day vitamin D supplement will achieve a blood vitamin level >75 nmol/L~     compared to children receiving 10 ug/day. This data will aid policy makers, parents/children~     and healthcare workers in recommending an appropriate vitamin D dosage for the pediatric~     crohn's population.~   "
142651|NCT01187446|"~     The purpose of this study is to determine if vorinostat combined with low-dose total skin~     electron beam therapy (TSEBT) offers superior clinical benefit (efficacy & safety) over~     low-dose TSEBT alone.~   "
142652|NCT01187433|"~     The purpose of this study is to generate immunogenicity and safety data in preparation for~     efficacy studies in Latin America.~      Primary Objectives:~        -  To describe the immune response to dengue viruses before and after each vaccination~          with CYD dengue vaccine.~        -  To evaluate the safety of each vaccination with CYD dengue vaccine.~   "
142653|NCT01187420|"~     The purpose of this study is to assess real time changes in raw and processed EEG in~     relation to the clinical and radiological evidence of cerebral vasospasm.~   "
142654|NCT01187407|"~     The purpose of this study is to assess if LY2216684 (fixed 6 mg or flexible 12 mg to 18 mg~     once daily) is superior to placebo once daily in the adjunctive treatment of participants~     with major depressive disorder (MDD) who were identified as partial responders to an~     adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an~     11-week, double-blind, acute adjunctive treatment phase.~   "
142656|NCT01187381|"~     This single arm observational study will assess the duration and safety of treatment with~     Herceptin (trastuzumab) in routine clinical practice in patients with early or metastatic~     HER2-positive breast cancer. Data will be collected from female patients treated with~     Herceptin according to the Summary of Product Characteristics and local protocols. Duration~     of observation for each patient is from therapy initiation until permanent discontinuation~     for any cause.~   "
142657|NCT01187368|"~     The objective of this pivotal study is to assess the safety and efficacy of the EVAHEART~     LVAS as a bridge-to-transplant for subjects with end stage heart failure. Subjects will be~     followed for 180 days after the EVAHEART LVAS implant or until cardiac transplant or explant~     for recovery (+ 60 days or discharge). If after 180 days post-implant the subject has not~     received a cardiac transplant or the device has not been explanted, the subject will~     continue to be followed monthly.~   "
142658|NCT01187355|"~     The purpose of this study is to compare two contact lens care solutions in symptomatic~     wearers of silicone hydrogel contact lenses.~   "
142659|NCT01187342|"~     Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute~     and chronic poststroke conditions.~   "
142660|NCT01187329|"~     The overall research plan is to test the hypothesis that intraoperative treatment of~     hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial~     function and short-term outcomes compared with standard glucose management.~   "
142661|NCT01187316|"~     The aim of the present study was to carry out a pilot project comparing the effectiveness of~     two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight~     female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis~     1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and~     2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten~     sessions were held for each patient and two measurements (baseline and 10th session) were~     performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum~     opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be~     carefully selected.~   "
142662|NCT01187303|"~     The purpose of this trial is to determine the efficacy of ofatumumab in patients with~     relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).~   "
142663|NCT01187290|"~     The main objective of this trial is to compare feasibility and efficacy of sequential~     neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone.~     Secondary objectives are to assess the value of position emission tomography (PET）in~     predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell~     lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa~     NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and~     during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic~     acid (DNA) variation with tumor response, remission duration and overall survival.~   "
142664|NCT01187277|"~     The incidence of stroke in the industrial world is still high. Most of the patients are~     suffering from paresis of the affected side, speech and cognition problems. Modern concepts~     of motor learning after stroke favouring a task-specific repetitive high-intensity therapy~     approach to promote motor outcome. In the last couple of years robot-assisted therapy became~     an important part of modern rehabilitation after stroke. But so far there is no clear~     evidence that robot assisted therapy in combination with conventional therapy is more~     effective than conventional therapy alone to promote motor functions after stroke.~   "
142665|NCT01187264|"~     In this study the investigators intend to compare the efficacy and safety of two fixed doses~     of once weekly oral methotrexate in a prospective randomized double blind manner in patients~     with severe plaque type psoriasis.~   "
142666|NCT01187251|"~     The aim of this study is to compare the incidence of tinnitus between mp3 users and~     non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença~     secondary schools. High frequency audiometry and otoacoustic emissions will be~     performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.~   "
142667|NCT01187238|"~     The purpose of this study is to verify the role of adding cisplatin chemotherapy to the~     intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.~   "
142668|NCT01187225|"~     The purpose of this study is to evaluate prospectively whether concentrate fibrinogen~     reduces blood losses, transfusion requirements and occurrence of clinical complications~     compared to cryoprecipitate in children after cardiac surgery with pump.~   "
142669|NCT01187212|"~     This study investigates the efficacy and safety profiles of sorafenib in combination of~     capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced~     gastric cancer.~   "
142670|NCT01187199|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of~     3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar).~     The safety of these drug combinations will also be studied.~   "
142671|NCT01187186|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral~     administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with~     normal hepatic function based on the Child-Pugh Classification (CPC).~   "
142672|NCT01187173|"~     Goal:~      The primary goal of this study is to longitudinally investigate, in head and neck cancer~     (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine~     the development, patterns, progression, and prevalence of late-effect fibrosis and/or~     lymphedema, explore potential biological correlatives including pro-inflammatory cytokines~     and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or~     lymphedema and select psychosocial stressors that potentially interact with cytokine~     pathways.~      H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or~     lymphedema.~      H: We will be able to differentiate characteristics patterns of the development of~     late-effect fibrosis and/or lymphedema.~      H: We will be able to differentiate patterns of symptoms associated with late-effect~     fibrosis and/or lymphedema.~      H: We will be able to differentiate patterns of inflammatory response and the development of~     late-effect fibrosis and/or lymphedema.~      H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis~     and/or lymphedema.~      H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with~     total dose of radiation to involved anatomical site.~      H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and~     social withdrawal than those without these conditions.~   "
142673|NCT01187160|"~     The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive~     Surgical, Inc., Sunnyvale, CA) allows for adequate exposure for transoral resection of~     hypertrophic lingual tonsils in patients with obstructive sleep apnea.~   "
142674|NCT01187147|"~     Asthma is a disease characterized by chronic inflammation in the airways. Recent research~     has demonstrated that one of the reasons for the chronic inflammatory state is an imbalance~     between oxidative stress and antioxidative defenses in patients with asthma.~      Green tea is a common beverage consumed by Chinese patients from all walks of life. Green~     tea contains chemical components that are thought to have immunomodulatory actions in~     chronic inflammation.~      The investigators propose to recruit 35 patients with stable asthma. Recruited subject will~     be given oral tablets containing Green tea extract (GTE) to be taken daily for three months.~     Clinical follow up and assessment will be done at baseline, on completion of GTE intake at~     three months, and at three months after GTE intake has been stopped. A questionnaire on~     their health status and the frequency of symptoms and use of bronchodilators and inhaled~     steroids will be completed, spirometry will be done and a venous blood sample will be taken~     during recruitment and during each reassessment at 3 and 6 months. Measurement of~     oxidants/antioxidants (GSH, GSSG, SOD, CAT and GPx) will be carried out on the blood~     samples. Oxidants/antioxidants will be compared and correlated with lung function results.~      This study would provide us with pilot data as to whether GTE, a strong antioxidant with~     immunomodulatory actions, has any effect on reducing the oxidative stress and improving the~     antioxidant status in patients with asthma and whether these changes are accompanied~     improvement in clinical status.~      Hypothesis Green tea extract (GTE) reduces oxidative stress and improves antioxidant~     defenses in Chinese patients with asthma~   "
142675|NCT01187134|"~     Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast~     and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend~     the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent~     studies showed that such treatment is delayed for several hours.~      In this study, medical staff of participating hospitals is trained to achieve a duration~     until antimicrobial therapy of less than 1 hour. Tools of change management are used. The~     data are compared to a control group (hospitals without intervention).~      It is hypothesized that a multifaceted educational program decreases duration until~     antimicrobial therapy and improves survival.~   "
142676|NCT01187121|"~     The objective of this three year project funded by the National Institute of Justice is to~     conduct a program evaluation of the Decide Your Time program at the Hares Corner Office of~     the Delaware Department of Probation and Parole. The program is intended to provide an~     alternative to incarceration by monitoring chronic drug offenders through increased,~     regularly scheduled, known urinalysis testing, coupled with increasing sanctions and~     referral to treatment for positive tests. The program was designed and is being implemented~     by the Delaware Department of Probation and Parole. Offenders will become eligible for the~     program when they test positive for drugs at their initial probation intake at the Hare's~     Corner Probation Office in New Castle, Delaware or are moved from standard probation to~     intensive supervision due to failed urine tests. Due to budgetary constraints, the office~     lacks sufficient resources to place all eligible offenders into the program. The Department~     of Probation thus intends to randomly assign eligible offenders to either intensive~     supervision probation (ISP)(n=400) or the Decide Your Time program(n=400). Those in ISP will~     receive the normal intensive supervision requirements, including weekly visits and random~     urinalysis. Those in the enhanced condition will receive regularly scheduled urinalysis~     coupled with referral to treatment, if required, and a program of graduated sanctions. The~     Center for Drug and Alcohol Studies is conducting an evaluation of the program that involves~     examining data on effectiveness, and collecting and examining data on program~     implementation, and probation officer and client perspectives of how the program worked. It~     is hypothesized that those randomized to the Decide Your Time program will have fewer~     arrests, violations and positive urine screens upon program completion than those randomized~     to the control condition.~   "
142677|NCT01187108|"~     Chronic mountain sickness is characterized by excessive red blood cell production which~     causes sludging of the vascular system. This high viscosity blood causes heart failure,~     cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been~     previously been shown to be an environmental pollutant worsens the overproduction of red~     blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide~     (already shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that~     removes cobalt from the blood) are evaluated in their potential to improve chronic mountain~     sickness.~   "
142678|NCT01187095|"~     Many couples experience involuntary childlessness and seek treatment at fertility clinics.~     Going through treatment procedures can be very challenging, time consuming and emotionally~     demanding.~      Psychosocial intervention might have a soothing and healing effect on both behavior as well~     on physical matters. Hence, the investigators would like to investigate whether Expressive~     Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy~     rate for couples who are going through fertility treatment.~   "
142679|NCT01187082|"~     Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder~     syndrome) equals the effect of bladdertraining individually for patients with overactive~     bladder.~      The effect of the training is measured in a 3 dimensional scope by the means of 3 primary~     outcome measures used in the statistical evaluation. Symptoms of OAB (either~     (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).~   "
142680|NCT01187069|"~     A huge challenge in type 2-diabetes care is how to motivate patients towards health~     behaviour changes. In Denmark, the tendency is that nurses in general practice provide a~     large part of type 2 diabetes care.~      Observational studies support Self-determination Theory by finding autonomous motivation and~     perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes.~     Hence, research is needed to develop and test interventions that are autonomy supportive.~      Aim To develop a training course for practice-nurses in autonomy support in patients with~     type 2 diabetes, and to evaluate the effect on patient outcomes.~      Methods The development of the intervention was based on literature research and expert~     meetings. The intervention is evaluated in a cluster randomised controlled trial with 40~     Danish general practices,~        -  where nurses, before enrolment in the study, provided consultations to patients with~          type 2 diabetes,~        -  and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.~      The patients will be followed 15 months from nurse-participation in the course. Data will be~     obtained from registers and patient-questionnaires. The hypothesis is that patients with~     type 2 diabetes regardless of education level, age, and gender will benefit from the~     intervention.~   "
142714|NCT01186627|"~     A specified version of the Apgar-Score, that can be used in newborns under resuscitation,~     was developed and its value to predict chronic damage in preterm infants will be tested.~   "
142758|NCT01186055|"~     In the current study, the investigators propose to test: (1) whether brain activation and~     connectivity in a resting state, assessed by ASL perfusion MRI, BOLD fMRI, and diffusion~     tensor imaging (DTI) predicts smoking relapse, and (2) whether brain activation, assessed by~     BOLD fMRI during performance of neurobehavioral probes for executive cognitive function,~     stress and cue reactivity, predicts smoking relapse.~   "
142681|NCT01187056|"~     General practitioners (GPs) and patients find it difficult to talk about risk of future~     disease, especially when patients have asymptomatic conditions, and treatment options are~     unlikely to cause immediate perceptible improvements in well-being. Further studies in risk~     communication for disease prevention are needed, as are studies about risk communication~     training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex~     intervention comprising a training programme for GPs in risk communication and shared~     decision-making, 2) to evaluate the effect of the training programme on real-life~     consultations between GPs and patients with high cholesterol levels, and 3) to evaluate~     patients' reactions during and after the consultations. Hypothesis: 1) patients have better~     adherence to chosen treatment.~      The effect of the complex intervention, based around a training programme, will be evaluated~     in a cluster-randomised controlled trial with an intervention group and an active control~     group with 40 GPs and 280 patients in each group.~      The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards~     risk communication and cholesterol-reducing medication. After each consultation with a~     participating high cholesterol-patient, the GPs will complete a questionnaire about decision~     satisfaction.~      The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes~     questions about adherence to chosen treatment, self-rated health, patient enablement, and~     risk communication and decision-making effectiveness. Prescriptions, contacts to the health~     services, and cholesterol level will be drawn from the register of the National Health~     Service of Denmark at baseline and at 6 months.~      In both intervention group and active control group, 12 consultations will be observed and~     tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The~     patients from these 24 consultations will be interviewed immediately after the consultation~     and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention~     group will be interviewed in a focus group 6 months after participation in the training~     programme. The process and context of the RISAP-study will be investigated in detail using~     an action research approach, in order to describe and analyse research choices, adaptation~     of intervention model to the specific context, and GPs' and patients' reactions to trial~     participation.~   "
142682|NCT01187043|"~     The purpose of this study is to determine the effects of five different doses of Proellex on~     menses, ovulation, liver function, and steady state exposure in women of reproductive age.~   "
142683|NCT01187030|"~     There is little evidence to guide the current use of Frozen Plasma. Despite this, over~     260,000 units of frozen plasma are transfused in Canada annually. Based on the limited~     published data available, the pattern of practice for Frozen Plasma transfusions is highly~     variable and an important number of Frozen Plasma transfusions appear to be inappropriate.~     Given inappropriate use, it is inevitable that a percentage of patients experience~     unnecessary and potentially life-threatening adverse transfusion reactions. Current~     guidelines for Frozen Plasma offer little help in guiding specific clinical decisions as~     their recommendations lack sufficient clinical details. This lack of detail also hinders the~     utility of these guidelines to help monitor and improve clinical practice. Further research~     examining Frozen Plasma transfusions including an understanding our current use is critical~     to improve the utilization of this valuable and limited resource.~   "
142684|NCT01187017|"~     Background:~        -  Severe aplastic anemia (SAA) can lead to problems with bone marrow health and result in~          low blood cell counts, which require frequent transfusions. Standard initial treatment~          for SAA involves injections of antithymocyte globulin (ATG) plus cyclosporine (CsA).~          Patients with SAA who do not respond to initial treatment with ATG (refractory) have a~          high risk of dying without additional treatment. In these cases, for those who do not~          have a matched bone marrow transplant donor there is no well-defined standard therapy.~          In our experience with patients who do not respond to horse ATG + CsA, only about~          one-third of patients who are re-treated with rabbit ATG + CsA improve. Experience with~          cyclophosphamide in the treatment of refractory severe aplastic anemia suggests that~          this drug is able to improve blood counts in about 50% of cases. However, the~          cyclophosphamide regimen has been associated with a significant infection risk (mostly~          caused by fungus) in studies conducted over 10 years ago due to the lowering of the~          white blood cell levels.~        -  Better antibiotic drugs against fungus have been developed and are widely used to treat~          patients who have low white blood cell counts and are at risk of developing infections.~          In SAA patients in particular, these newer antibiotics have had a large impact in~          preventing and treating fungus infections. Researchers are revisiting the use of~          cyclophosphamide at lower doses to minimize its side effects given in combination with~          another immune suppressant, fludarabine.~      Objectives:~      - To determine the safety and effectiveness of the combination of fludarabine plus~     cyclophosphamide in treating severe aplastic anemia that has not responded to initial~     treatments.~   "
142685|NCT01187004|"~     Hypothesis of the study is that patients undergoing major cardiac surgery can develop~     extracardiac complications correlated to cardiopulmonary by pass.~   "
142686|NCT01186991|"~     This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed~     to preliminarily estimate the efficacy and evaluate the safety and tolerability of~     onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel~     versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally~     recurrent, triple-negative breast cancer who either have not received treatment (first-line)~     or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).~   "
142687|NCT01186978|"~     This study will evaluate whether a reduction in the radiation dose and field size will~     maintain a high rate of local control while minimizing the risk of acute and late toxicity.~      Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20~     Gy while maintaining high rates of local control in patients who had a negative PET scan~     following rituximab-containing chemotherapy.~   "
142688|NCT01186965|"~     The purpose of this study is to to develop and evaluate the feasibility, usability, and~     effect of participation in SLIDES (a virtual diabetes community in Second Life) for~     providing interactive diabetes education, support, and resources.~   "
142689|NCT01186952|"~     Inactivity and excess energy consumption are leading causes of obesity and type 2 diabetes~     which are associated with increased cardio-metabolic risk. In order to reduce the~     cardiovascular risk associated with type 2 diabetes, the Canadian Diabetes Association~     guidelines (2008) recommends weight loss through caloric restriction and structured physical~     activity. However, the comparative effects of different methods to obtain caloric deficit~     for weight loss remains to be elucidated. The main objective of this study is to assess the~     impact of two strategies of caloric deficit: diet alone or diet and exercise on total fat~     mass, epicardial fat and cardiovascular risk factors in overweight and obese adults with~     type 2 diabetes and at high risk of cardiovascular disease.~   "
142690|NCT01186939|"~     At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could~     be enrolled in an optional extension phase in order to continue treatment with azacitidine~     until it became commercially available; the continued treatment was for ethical and safety~     reasons only and not to provide additional efficacy data.~   "
142691|NCT01186926|"~     The overall goal of the study is to evaluate the safety, efficacy and therapy settings of~     the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in~     subjects with obstructive sleep apnea (OSA).~   "
142692|NCT01186913|"~     People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections~     as a result of inherited defects in the genes that normally instruct blood-forming cells to~     develop and to fight infections. PID diseases include Severe Combined Immune Deficiency~     (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated~     by transplantation of bone marrow stem cells from a healthy person or, in some cases, by~     enzyme replacement or by gene therapy. Patients with SCID were among the first to receive~     bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40~     years ago, and HCT is the standard treatment today for this group of diseases. Since PID~     diseases are rare, there are not enough patients at any single center to determine the full~     range of causes, natural history, or best methods of treatment. For this research study many~     PID centers across North America have organized into the Primary Immune Deficiency Treatment~     Consortium (PIDTC) to pool their experience and study PIDs together. The overall goal of~     this study is the prospective evaluation of children with SCID and related disorders who are~     treated under a variety of protocols at participating institutions. The study aims to~     identify variables contributing to the best outcomes for HCT.~   "
142693|NCT01186900|"~     The investigators propose to conduct a, two armed, randomized, controlled pilot study to~     assess the clinical effects of a) open incision, drainage with daily packing changes,~     compared to b) Ultrasound guided needle aspiration, in drainage of uncomplicated cutaneous~     abscesses below the skin surface of adult emergency department patients using concealed~     allocation in evaluating patient satisfaction.~   "
142694|NCT01186887|"~     The aim of this study is to directly compare the clinical outcomes of both the celecoxib and~     placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will~     have short and long term goals. Validated outcome measures will aim to quantify pain control~     at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be~     compared using pain control scales, and functional knee outcome scores. The first null~     hypothesis tested by this study is that the celecoxib group experiences equal pain control~     compared with the placebo group. The second null hypothesis is that no knee function~     difference will be found between the celecoxib and placebo groups.~   "
142695|NCT01186874|"~     To survey the prevalence and the mortality of the Acute Lung Injury/ Acute Respiratory~     Distress Syndrome (ALI/ARDS) in 12 university hospital ICUs in Shanghai.~   "
142696|NCT01186861|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1~     randomization scheme.~   "
142697|NCT01186848|"~     This was a prospective randomized controlled study comparing the efficacy of micro-focused~     ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus~     1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch~     marks).~      Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser~     treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side~     received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively~     every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on~     each side.~      The primary outcome measure by two dermatologists blindly compared the two areas of striae~     distensae on each side from live subjects using a questionnaire and quartile rating scale on~     the final follow-up visit.~      This study was a pilot study designed to determine the feasibility of these procedures.~   "
142698|NCT01186835|"~     The objective of this study is to determine whether the use of botulinum toxin (Dysport ®)~     in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of~     wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum~     toxin alone. These two products have been FDA approved to improve the appearance of facial~     wrinkles.~   "
142699|NCT01186822|"~     This is a 26 week randomized controlled study. The study consists of, in order, an~     enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will~     also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve~     comprehensive assessments of the patients lung condition, including post-bronchodilator~     spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ).~     Sputum and serum samples will also be collected at these visits for microbiological and~     inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device~     and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and~     telephonic visits will collect information regarding compliance with the use of the Lung~     Flute, adverse events and exacerbation history.~   "
142700|NCT01186809|"~     The purpose of the Phase IIA study are to:~        1. define the safety profile~        2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte~          Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular,~          cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and~          The progression free survival and the overall survival after the sequential infusion of~          Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.~   "
142701|NCT01186796|"~     Participants are being asked to take part in this research study to learn why growth~     hormone(GH) levels decline when estrogen production falls at the time of menopause. GH is a~     hormone released from the pituitary gland that affects bone, muscle, and fat. Estrogen is a~     female hormone. Doctors believe that lower estrogen is one of the reasons that GH diminishes~     in postmenopausal women. However, estrogen does not fall completely. This raises the~     question whether the little bit of estrogen that is left is doing anything. Lack of GH makes~     bones thinner, muscles weaker, and fat stores larger. To learn whether the low amount of the~     body's own estrogen maintains GH secretion after menopause, the investigators need to stop~     any estrogen you might be taking and then partially block the effect, if any, of your own~     estrogen. The investigators will use a new estrogen-blocking drug (fulvestrant).~     Fulvestrant(which also goes by the tradename, Faslodex) was recently approved by the Food~     and Drug Administration (FDA) to treat breast cancer. Fulvestrant is being used in a non-FDA~     approved manner in this study (not to treat breast cancer, but to study the effect on Growth~     Hormone secretion). The drug interferes with how estrogen works in the body, except in the~     brain. The study that you are considering now tests whether your own estrogen works outside~     the brain to maintain GH secretion in postmenopausal women. This concept is important,~     because the brain controls how the pituitary gland secretes GH.~   "
142702|NCT01186783|"~     MODIfY is a prospective, single center, open label, randomized, controlled two arms, Phase~     II-trial to evaluate the ability of ivabradine to reduce an elevated heart rate in Multiple~     Organ Dysfunction Syndrome (MODS) patients. The primary end point is the proportion of~     patients with a reduction of heart rate by at least 10 beats per minute (bpm) within 4 days.~     This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed~     MODS (Acute Physiology and Chronic Health Evaluation (APACHE) II-score ≥ 20, diagnosis~     within ≤ 24 hours), with an elevated heart rate (sinus rhythm with HR ≥ 90 bpm) and~     contraindications to beta-blockers (BBs). Treatment period will last 4 days. All patients~     will be followed for up to six months.~   "
142703|NCT01186770|"~     MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind,~     placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of~     oral MNTX for the treatment of opioid induced constipation in subjects with chronic,~     non-malignant pain.~   "
142704|NCT01186757|"~     Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers~   "
142705|NCT01186744|"~     The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550~     (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and~     subsequent withdrawal of active treatment at various timepoints during the 16 week double~     blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP~     690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal~     and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg~     BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are~     candidates for systemic therapy or phototherapy.~   "
142706|NCT01186731|"~     LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc.~     Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell~     division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced~     toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence~     obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered~     at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown~     positive activity of protein bound taxane therapy in treating patients with pancreatic~     cancer. The current Phase II study is designed to accomplish the following objectives:~        1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every~          three weeks in pancreatic cancer patients with locally advanced or metastatic disease~        2. To evaluate the progression-free survival and overall survival~        3. To correlate secreted protein acid rich in cysteine expression with tumor response~        4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention~          as well as myelotoxicity~        5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic~          endpoints, including toxicities.~   "
142707|NCT01186718|"~     The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern~     changes that result from osteopathic manipulation treatment (OMT) in an experimental subject~     group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D~     motion trajectories of the head, resulting in range of motion (ROM) and angular data for the~     primary and secondary motions.~   "
142708|NCT01186705|"~     The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal~     cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose~     tumors have changes in certain genes that may make them more likely to respond to this new~     medication. As tumors develop, the cells within the tumor acquire mutations within genes,~     allowing them to grow more effectively. We will be testing your tumor for mutations~     involving two genes - KRAS and PIK3CA. Patients whose tumors have a normal copy of the KRAS~     gene and a mutation within the PIK3CA gene will be eligible to participate in this study.~      This study is a phase 2 study. The goal of a phase 2 study is to find out what effects, good~     and/or bad, a new treatment has against a certain type of cancer.~   "
142709|NCT01186692|"~     The purpose of this study is to confirm the short-term hemodynamic effectiveness results~     achieved by real-world providers are equivalent to the historical control established in the~     IDE study.~   "
142710|NCT01186679|"~     The projected data related to the burden of spinal cord injuries induced limb paralysis in~     India is quite alarming. This is attributed to the rapid industrialization and economical~     development in the country. Increase in vehicular traffic has caused numerous road traffic~     accidents. Rapid increase in populations, development in the computer technology and real~     estate business lead to construction of huge buildings which indirectly adds to the injuries~     due to fall. Spinal cord injuries could not be treated adequately with the prevailing~     treatment modalities. In view of this, there is definitely an urgent need for finding~     different methods of treatment for these patients who cannot undergo established modalities~     of treatment or these have been tried unsuccessfully. Since a large number of these patients~     will loose their productive life and at the prime of their lives, one such alternate~     therapy, which seems to offer some promise, is stem cell therapy, which has been well~     studied and published in prestigious journals.~      In our present study, we want to evaluate the safety and efficacy of autologous bone marrow~     derived stem cells surgically transplanted directly into the lesion site with glial scar~     resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for~     4 indian patients of acute and subacute injury.~   "
142711|NCT01186666|"~     In this study, multimodal imaging of atherosclerosis and dosage of new circulating~     biomarkers will be used to compare patients with stable or unstable coronary artery disease~   "
142712|NCT01186653|"~     National Institute for Clinical Excellence (NICE) guidelines recommend high dose inhaled~     steroids for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD, a~     common chronic disease related to smoking) who are having two or more exacerbations~     requiring treatment with antibiotics or oral steroids in a 12 month period. The preparations~     licensed for this indication commercially available are Symbicort® and Seretide®. High dose~     inhaled steroids (contained in both) can cause suppression of the adrenal glands. The~     investigators want to assess adrenal suppression caused by the two preparations and compare.~     The results could guide investigators in prescribing these preparations.~   "
142713|NCT01186640|"~     Study hypothesis: Simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab~     maintenance therapy in patients with T-PLL is feasible, safe and efficient.~   "
142715|NCT01186614|"~     Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The~     most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation~     by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of~     adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the~     patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic~     resuscitation are not routinely transported to hospital because it is hazardous for~     paramedics to undertake rapid transport whilst administering chest compressions and there is~     currently no additional therapy available at the hospital that would assist in starting the~     heart.~      However, a number of recent developments suggest that there may be a new approach to the~     resuscitation of this group of patients who would otherwise die.~      Firstly, Ambulance Victoria have recently introduced portable battery powered machines that~     allow chest compressions to be safely and effectively delivered during emergency ambulance~     transport.~      Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in~     cardiac arrest can immediately be placed on a heart-lung machine. This is known as~     extra-corporeal membrane oxygenation (ECMO).~      Third, the brain can now be much better protected against damage due to lack of blood flow~     using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C~     to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage~     after OHCA.~      Finally, The Alfred Cardiology service has an emergency service for reopening the blocked~     artery of the heart in patients who present with a sudden blockage of the heart arteries.~     This is currently not used in patients without a heart beat because of the technical~     difficulty of undertaking this procedure with chest compressions being undertaken.~      This study proposes for the first time to implement all the above interventions when~     patients have failed standard resuscitation after OHCA. When standard resuscitation has~     proved futile, the patient will be transported to The Alfred with the mechanical chest~     compression device, cooled to 33°C, placed on ECMO, and then transported to the~     interventional cardiac catheter laboratory. The patient will then receive therapeutic~     hypothermia for 24 hours. Subsequent management will follow the standard treatment~     guidelines of The Alfred Intensive Care Unit.~   "
142716|NCT01186601|"~     The study will be conducted as an open label, single-dose, explorative study with patients~     with histologically proven cancer and, preferably, tumor positive lesions in previously~     performed nuclear medicine imaging examinations.~      The investigational drug will be given as a single administration in a dose of </= 0.1 mg~     BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be~     approximately 8 days.~   "
142717|NCT01186588|"~     The purpose of the study is to determine the concentration of canagliflozin in blood and~     urine samples after the administration of canagliflozin to study participants with mild or~     moderate hepatic (liver) impairment compared with study participants with normal hepatic~     function.~   "
142718|NCT01186575|"~     Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and~     UNAIDS recommend that male circumcision should be recognized as an efficacious intervention~     for HIV prevention especially in countries and regions with heterosexual HIV epidemics and~     low male circumcision prevalence. As a result, programs have been introduced and scaled up~     for voluntary medical male circumcision. Kenya leads with the largest expansion of services.~      Early resumption of sexual intercourse after MC may have deleterious effects, including~     higher rates of post-operative surgical complications, and higher HIV acquisition among~     females in couples that resume sexual activity before certified wound healing. In the~     context of rapid scale-up of MC, adherence to post-operative clinic appointments allows~     clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from~     sexual intercourse before complete wound healing would reduce the rate of post-operative~     adverse events and minimize the risk of HIV transmission from HIV-infected men to their~     uninfected female partners.~      To the investigators knowledge, the effect of reminders delivered via text messaging to~     promote adherence to clinic visits and abstinence after MC has not been investigated. The~     investigators propose a randomized controlled trial in which men who will have undergone~     voluntary medical male circumcision at selected sites in Kisumu will be randomized to~     receive either the intervention (context-sensitive text messages after circumcision) or the~     control condition (usual care). This study seeks to determine (a) the effect of regular text~     messages sent to men after circumcision on attendance of the scheduled 7-day post-operative~     clinic visit versus usual care; (b) the proportion of men who resume sexual activity before~     42 days post-procedure after receiving regular text messages versus usual care within the 42~     days post-circumcision; and (c) to identify potential predictors of failure to attend the~     scheduled 7-day post-operative visit and early resumption of sexual intercourse.~   "
142719|NCT01186562|"~     The purpose of the study is to test the effects of sitagliptin on the need for insulin (the~     hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet~     autotransplant for chronic pancreatitis.~   "
142720|NCT01186549|"~     Objectives: Injection pain and hypotension are two main adverse effects of propofol which~     distresses patient. The aim of this prospective double blind study was to compare the effect~     of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and~     hemodynamic changes due to propofol induction.~      Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5~     groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30),~     ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml~     saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was~     injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate~     were recorded before induction, just before intubation, and one minute after intubation~   "
142721|NCT01186536|"~     The objective of this project is to determine the effect of 9 months of progressive~     resistance training with daily whey protein supplements on the body composition (changes in~     muscle and fat) in young adults. The investigators hypothesize that those individuals who~     receive whey protein supplements will have larger gains in muscle and larger losses of fat~     tissue in response to resistance training compared to those who receive supplements of soy~     or carbohydrate.~   "
142722|NCT01186523|"~     In order to examine potential gender differences in the weight loss response to exercise,~     the investigators propose to compare equal energy expenditure of exercise for overweight men~     and women using levels of exercise energy expenditure that the investigators have previously~     shown to prevent weight gain or promote weight loss. The investigators will randomize men~     and women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400~     kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The~     investigators hypothesize that men and women randomized to sedentary control will gain~     weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain),~     and those randomized to 600 kcal/exercise session will lose ~5% of body weight. 2) The~     investigators hypothesize there will be no differences for weight loss between genders at~     either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal~     amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and~     women randomized to 400 kcal/exercise session will completely compensate for the energy~     expended during exercise by altering energy intake and/or spontaneous activity and that men~     and women participants randomized to 600 kcal/exercise session will not completely~     compensate. The investigators believe the findings from this study could have important~     implications for exercise guidelines for weight loss.~   "
142723|NCT01186510|"~     Pulmonary dysfunction presumably linked to an inflammatory response is frequent after~     cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.~      Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with~     oxygenated blood during aortic crossclamping on the inflammatory response.~   "
142724|NCT01186497|"~     The purpose of the study is to investigate the bioavailability (rate and extent of~     absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole~     sodium is mixed with different dosing vehicles (food, others) and is administered to healthy~     adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal~     Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to~     stomach) becomes irritated or inflamed because of acid backing up from the stomach.~   "
142725|NCT01186484|"~     The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to~     select the recommended dose of JNJ-212082 for patients with castration resistant prostate~     cancer.~   "
142726|NCT01186471|"~     This study in patients with stable schizophrenia will investigate the effect of nicotine on~     arousal, cognitive task and social cognition after acute dose administration.~   "
142727|NCT01186458|"~     The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and~     rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin~     lymphoma.~   "
142728|NCT01186445|"~     The purpose of this study is to determine whether intracoronary injection of morphine~     chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary~     angioplasty in patients with acute myocardial infarction (AMI).~   "
142729|NCT01186432|"~     This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with~     neovascular AMD.~   "
142730|NCT01186419|"~     The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new~     oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a~     medication taken by mouth that causes the body to get rid of iron. Iron chelators are used~     in patients with β-thalassemia and other forms of anemia who experience iron overload - iron~     increases in the body as a result of regularly required blood transfusions. Patients who~     qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6~     months) with a total study duration of up to 33 weeks. These patients will be eligible to~     participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be~     up to 96 weeks. The safety of patients will be monitored frequently during the study by~     physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart,~     each patient must undergo 6 MRI scans during the study. Patients will not need to stay in~     the hospital for this study but will need to visit the outpatient clinic up to 28 times over~     the 96 week period. Patients currently taking an iron chelator will be required to stop for~     a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may~     be effective as an iron chelator.~   "
142731|NCT01186406|"~     The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at~     the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and~     then the combination of Avastin and Temodar, after radiation is complete, on malignant brain~     tumors.~      About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose~     of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation.~     Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed~     dose of Avastin intravenously (through the vein) every 14 days. They will also be given a~     higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.~   "
142732|NCT01186393|"~     The purpose of this study is to test whether diets that contain potatoes and differ in~     glycemic index/load will be useful in weight loss, blood sugar control and maintaining~     current body weight.~   "
142733|NCT01186380|"~     The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as~     it is inserted and transitioned into the esophagus through the mouth.~   "
142734|NCT01186367|"~     The purpose of this study is to compare the effects of 3 different approaches to exercise~     training in women with early stage breast cancer who have completed all primary treatments~     (except hormone therapy, if appropriate). Prior research in women with early stage breast~     cancer has shown that some treatments may have an adverse impact on physical fitness levels~     leading to feelings of fatigue and poor quality of life. Supervised exercise training has~     been shown to reduce some of these side-effects. However, all the exercise programs have~     followed essentially the same approach. This study is designed to see if a different~     approach to exercise training is more effective than the conventional approach currently in~     use.~   "
142735|NCT01186354|"~     This research study is being conducted to learn about how health and genetic literacy (i.e.,~     how well a person understands health and genetic information) affects a person's ability to~     understand genetic risk information for Type 2 diabetes and whether that person chooses to~     change their lifestyle and health behaviors to reduce their risk. The investigators also~     want to learn if the manner in which the genetic risk information is communicated affects~     the level of understanding and potential behavior changes. Participants will be tested for~     genetic risk of developing Type 2 diabetes and will received results either via a web-based~     computer program, or in-person from a genetic counselor.~   "
142736|NCT01186341|"~     Preliminary results from an ongoing cross-sectional survey of nine of the BraveNet~     Outpatient Clinics indicate that pain was the leading reason for patient visits. As a~     precursor to a large multi-site clinical trial, this study aims to determine the feasibility~     of collecting outcomes data on integrative treatment for pain. These preliminary data will~     also provide an estimation of effect size for powering the multi-site clinical trial.~   "
142737|NCT01186328|"~     An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells~     at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is~     to find out the dose of EZN-3042 that can be safely given without serious side effects both~     alone and in combination with standard chemotherapy drugs during re-induction.~   "
142752|NCT01186133|"~     The objective of this study is to evaluate effectiveness and safety of the new drug-eluting~     stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the~     real world daily practice.~   "
142753|NCT01186120|"~     This randomized study is a multi-center, randomized, study to compare the efficacy of~     biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long~     coronary lesions.~   "
142754|NCT01186107|"~     The purpose of this study is to establish the safety and effectiveness of coronary stenting~     with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment~     of de novo coronary stenosis in patients with diabetic patients.~   "
142738|NCT01186315|"~     Eligible veterans, National Guardsmen & Reservists with post-traumatic stress disorder~     (PTSD) and problems with addiction will be randomly assigned to one of two treatment~     conditions. All participants will undergo exposure therapy, a gold standard behavioral~     treatment for PTSD for 10 weeks. In addition to exposure therapy, some participants will be~     randomly assigned to receive (1) virtual reality (VR)-based exposure to cues for marijuana,~     cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of~     learning (extinction reminders, or, ERs) to VR exposure (available 24 hours per day/7 days~     per week) to high-risk contexts for drug use. The main hypothesis is that those participants~     who receive exposure therapy + VR/ERs will demonstrate less substance use and lower PTSD~     symptoms during treatment, at post-treatment, and at follow-up than those participants who~     only receive exposure therapy. At study completion, a total of 123 subjects signed consent.~   "
142739|NCT01186302|"~     The purpose of the study is to compare the safety, effectiveness, and acceptability of~     medical abortion provided by doctors and midlevel providers in a developing country where~     doctors are scarce, such as Nepal. This study is the first to evaluate the independent~     provision of medical abortion by trained nurses and auxiliary nurse midwives compared to~     doctors by assessing differences in safety, clinical outcomes, case management~     decision-making, and acceptability. This study provides scientifically valid data on the~     administration of medical abortion by midlevel providers working independently in a~     low-resource, developing country setting. The evidence generated by the study will assist~     policy makers in developing countries interested in expanding safe abortion services by~     eliminating the legal requirement limiting prescription of medical abortion to doctors where~     medical abortion is not restricted by law.~   "
142740|NCT01186289|"~     The primary aim of our prospective, randomized, double-blind interventional clinical trial~     is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative~     cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize~     that therapy with high dose atorvastatin will significantly reduce the incidence and/or~     severity of POCD.~   "
142741|NCT01186276|"~     This study will assess whether dietary fiber supplements can reduce the production of~     chemicals which are produced by colon bacteria and normally excreted from the body by the~     kidney, but build up in the body in patients on hemodialysis.~   "
142742|NCT01186263|"~     The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled~     albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic~     artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres~     (SIR- spheres).~   "
142743|NCT01186250|"~     The purpose of this study is to determine the benefit of using the FDA-approved~     insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The~     objectives of this project are to (1) determine if pioglitazone effectively treats insulin~     resistance in heart transplant recipients, and (2) to determine whether pioglitazone therapy~     after heart transplantation impacts the development or progression of cardiac allograft~     vasculopathy (CAV), a form of chronic rejection after heart transplantation.~   "
142744|NCT01186237|"~     Recent national surgical quality guidelines (Surgical Care Improvement Project, National~     Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by~     post-operative day two for all surgical patients. These guidelines exclude neither patients~     who have undergone rectal surgery nor those with epidural analgesic catheters. The common~     practice among most colorectal surgeons is to leave urinary catheters in for three to five~     days for patients who have undergone rectal operations, due to concern for urinary~     retention. This study aims to explore the outcomes of following the national surgical~     guidelines for early urinary catheter removal, especially with regards to urinary retention~     and urinary tract infection.~   "
142745|NCT01186224|"~     To assess the efficacy and toxicity of plerixafor (AMD 3100) together with~     granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with~     myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.~   "
142746|NCT01186211|"~     This proposal outlines the investigators plan to develop, evaluate and implement an~     accelerated in hospital and community rehabilitation following total knee arthroplasty (TKA)~     leading to outpatient TKA. The benefits of applying current concepts of improved~     postoperative analgesia and less invasive surgical technique are expected to improve~     objective parameters of knee function, increase patients satisfaction, while reducing health~     care resources requirements as compared with standard rehabilitation. The innovation of~     combining best practices from orthopaedic sports medicine, Anesthesia, Physiotherapy and~     Knee reconstruction are expected to realize this goal.~   "
142747|NCT01186198|"~     This is a prospective, single-arm, open-label, multi-center, observational study to assess~     the acute safety and efficacy of MINI TREK RX 1.20 mm, for descriptive purposes only.~   "
142748|NCT01186185|"~     The standard of care treatment of sudden hearing loss uses a type of steroid called~     glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and~     dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone~     is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work~     by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In~     animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving~     hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The~     purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.~   "
142749|NCT01186172|"~     Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes~     it is very difficult to treat the infection and it is necessary to remove the device. The~     purpose of this study is to determine the efficacy of instilled ethanol (ethanol lock~     therapy) versus instilled antibiotics (antibiotic lock therapy) to save long-term venous~     device when infected, preventing their removal.~   "
142750|NCT01186159|"~     To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear~     leukocytes (PMNL) and macrophages, systemic and local inflammatory response and~     postoperative pain~   "
142751|NCT01186146|"~     This is randomized-controlled trial to evaluate the difference of composite of cardiac~     death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the~     aspirin monotherapy group after 1-year of drug-eluting stents implantation.~   "
142760|NCT01186029|"~     This study is looking at whether the addition of a fairly new drug for the treatment of~     post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting(PDNV)will~     provide added efficacy if added to 2 drugs that are already used as a standard of care for~     PONV and PDNV.~      The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on~     the procedure they are having done and/or on patient risk factors.~   "
142761|NCT01186016|"~     This study will test the effects of an educational program about genetics and smoking on~     smokers' thoughts, feelings, and behaviors before and after participating in smoking~     cessation treatment. This includes describing participants' knowledge about genetics and~     smoking, their use of strategies to stop smoking, and experiences when quitting smoking.~     This study will determine how smokers respond to information about genetics and smoking in~     anticipation of using genetic information to individualize pharmacological therapy for~     smoking cessation.~      Two groups will participate in this study. The experimental group will participate in two~     educational sessions about genetics and smoking. The control group will participate in two~     educational sessions about nutrition. Both the experimental and control groups will~     participate in a standard, group smoking cessation program with 6 weeks of OTC transdermal~     nicotine replacement therapy. Assignment to either of the two groups is random.~      The primary specific aim is to compare the effects of the experimental group to the~     attention control group on smoking-related mental representations, appraisals, behaviors,~     and affective responses over time. The secondary aim is to explore whether personality~     characteristics (trait negative affectivity and curiosity) and educational level moderate~     the effects of the genetic educational program on smoking-related mental representations,~     appraisals, behaviors, and affective responses. The hypotheses of the study are as follows:~        1. When compared to the attention control group, the experimental group will demonstrate:~             -  Smoking-Related Mental Representations:~             -  Greater knowledge of genetic contributions to smoking~             -  Greater endorsement of genetic contributions to smoking~             -  More positive attitudes towards NRT~             -  Increased abstainer and decreased smoker self-schemas~             -  Smoking-Related Appraisal: greater perceived risk for genetic predispositions to~               smoking~             -  Smoking-Related Behaviors: greater interest in genotyping.~        2. When compared to the attention control group, the experimental group will differ in:~             -  Smoking-Related Appraisals: self-efficacy for cessation and abstinence~             -  Smoking-Related Behaviors: number of quit attempts, abstinence, nicotine~               dependence~             -  Affective Responses: negative affect and intrusive/avoidant thoughts~   "
142762|NCT01186003|"~     The investigators anticipate that the use of Detemir will decrease the duration of an~     insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care~     unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the~     insulin drip is discontinued.~   "
142763|NCT01185990|"~     The study is designed to identify specific patterns of brain functional activity associated~     with chronic, moderate to severe tinnitus through the use of resting-state MEG scans. Robust~     patterns identified in this study will be used as a biomarker for subsequent clinical~     evaluation of experimental drug treatments for tinnitus. This study will conduct MEG scans~     on approximately 30 to 75 subjects with tinnitus and approximately 15 healthy control~     subjects. MEG scans will be obtained for each subject following screening, clinical and~     tinnitus evaluations. A subset of 6 subjects from the tinnitus cohort will be invited to~     undergo evoked auditory assessment during an extended MEG scan session to identify cortical~     regions that respond to the auditory stimulus. These six subjects also will be evaluated~     with a single structural MRI scan to support high-resolution mapping of the localized~     cortical regions. MEG data will be analyzed to identify patterns of brain activity that are~     specifically associated with the presence of tinnitus using both standard approaches and the~     Orasi Synchronous Neural Interaction™ (SNI) test. MEG scan results also will be evaluated to~     identify specific patterns of functional activity that correlate with other measures of~     tinnitus severity such as the Iowa Tinnitus Handicap Scale. This study will test the~     hypothesis that moderate to severe tinnitus is associated with altered patterns of brain~     functional activity measured by a brief, resting-state MEG scan. This hypothesis will be~     tested by comparing resting-state MEG scans of tinnitus patients with those the of healthy~     control subjects collected during this study and available in Orasi's existing MEG scan~     database.~   "
142764|NCT01185977|"~     This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in~     adolescent depression. Two specific hypotheses will be tested:~      H1: Early decreases in prefrontal cordance values will be greater in responders to~     antidepressant therapy than in medication non-responders.~      H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted~     to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in~     symptoms and in functional status than those with low ATR values.~      Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR~     values in medication and placebo-treated responders and non-responders.~   "
142765|NCT01185964|"~     The main purpose of this study is to gather information about the use of an investigational~     drug called IMC-3G3 with a drug for soft tissue sarcoma called doxorubicin.~   "
142766|NCT01185951|"~     Athletic tendinopathies of the upper and lower extremity are often therapeutically~     challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in~     painful tendons, which are associated with pain-mediating nerve fibres in such~     tendinopathies. These neovessels are represented by an increased capillary blood flow at the~     point of pain. Painful eccentric training reduces pain and improves function in Achilles~     tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with~     eccentric training is superior to eccentric training alone (evidence level Ib). Long-term~     results suggest a collagen induction and reduced pain following topical glyceryl trinitrate~     (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using~     polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence~     level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended~     (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence~     level Ib). The role of proprioceptive training in tendinopathy has to be determined in~     future randomized-controlled trials (evidence level II).~      The investigators thought to evaluate the combination of the aforementioned individually~     successfully therapeutic options in athletes to shorten the recovery period and return to~     play interval.~   "
142767|NCT01185938|"~     This open-label study, prospective, randomized trial evaluating the acute (in-hospital)~     pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with~     acute coronary syndrome~   "
142768|NCT01185925|"~     Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in~     approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.~      Pathophysiology seems quite complex and putative mechanisms include increased pulmonary~     capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in~     the pulmonary arterial system and instability of ventilatory control.~      Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary~     vascular tone and permeability through over signaling of the endothelial nitric oxide~     pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB~     pattern in patients with HF and pulmonary hypertension.~   "
142769|NCT01185912|"~     Retrograde cardioplegia during heart surgery is associated with inadequate myocardial~     protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte~     apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going~     elective aortic valve surgery will be divided in to two groups: 10 patients receiving only~     antegrade cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and~     post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery~     ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of~     the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after~     retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic~     cardiomyocytes correlates to conventional markers of myocardial injury after cardiac~     surgery, 3. whether the extent of irreversible myocardial damage by apoptosis correlates to~     post-ischemic contractile dysfunction after cardiac surgery, as measured with~     echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term~     outcome and cardiac function as measured with MRI.~   "
142770|NCT01185899|"~     Accurate detection of a heart attack (an acute myocardial infarction) is one of the most~     pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity~     of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not~     very accurate, especially at the beginning of a heart attack. A new technique for analysing~     a special part of the ECG may provide more accurate detection of a heart attack. The study~     hypothesis is that this new technique, the HFQRS analysis, will provide important additional~     information to that available from the regular ECG.~   "
142771|NCT01185886|"~     RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other~     body fluids from patients to test in the laboratory and collecting information about the~     patient's health and treatment may help doctors learn more about cancer and help the study~     of cancer in the future. Studying these samples in the laboratory may help doctors learn~     more about changes that occur in DNA and identify biomarkers related to cancer. It may also~     help doctors predict how patients will respond to treatment.~      PURPOSE: This research study is collecting and looking at blood and tissue samples in~     children with newly diagnosed acute lymphoblastic leukemia.~   "
142772|NCT01185873|"~     This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and~     the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers~     and patients with mild, moderate or severe hepatic impairment. Participants will be~     administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study~     treatment is 10 days.~   "
142773|NCT01185860|"~     This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591)~     plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with~     chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin.~     Patients in cohorts will be randomized to receive either oral doses of danoprevir, or~     danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys~     (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue~     this treatment after completion of study drug treatment. Anticipated time on study treatment~     is up to 12 weeks.~   "
142774|NCT01185847|"~     This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in~     combination with standard chemotherapy in patients with advanced or recurrent non-small cell~     lung cancer who have not received prior chemotherapy. In Part 1 patients will receive~     RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or~     pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In~     Part 2 patients will be randomized to receive either RO5083945 in combination with standard~     chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease~     progression, patients receiving RO503945 can continue treatment with RO5083945 as~     monotherapy.~   "
142775|NCT01185834|"~     The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact~     lens.~   "
142776|NCT01185821|"~     This blinded extension study is designed to offer patients with relapsing-remitting MS~     having completed the core study CBAF312A2201 access to BAF312 until they can enter an open~     label study. It will provide data on long-term safety, tolerability and efficacy of BAF312~     in this patient population.~   "
142777|NCT01185808|"~     The purpose of this study is to determine if Vitamin D supplementation improves clinical and~     immunologic parameters in chronic rhinosinusitis with nasal polyps.~   "
142778|NCT01185795|"~     Background: Several studies have reported limited or no reduction in serum lipid~     concentrations in response to probiotic formulations. More recently, probiotics have shown~     promise in treating metabolic disease, due to improved strain selection and delivery~     technologies.~      Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing~     microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken~     twice per day over 6 weeks, in subjects with hypercholesterolemia.~      Design: This is a double-blinded, multi-centric, placebo-controlled, randomized,~     parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out,~     2-week run-in, and 6- week treatment period.~   "
142779|NCT01185782|"~     Efficacy and safety studies in the past have suggested that a starting dose of 75~     International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are~     safe for treatment of subjects with ovulatory disorders who are infertile due to~     hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including~     oligomenorrhea and polymenorrhea).~      This was a phase III, multicentre, single-blind, parallel-group comparative study conducted~     to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin,~     a comparator drug, for induction of follicle development and ovulation in infertile Japanese~     women and to provide further information on the safety and tolerability of SJ-0021.~   "
142780|NCT01185769|"~     Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans~     remains unclear especially with different fat diets.This study aimed at evaluating the~     absorption and distribution of tocotrienols in plasma and lipoproteins in associations with~     high and low fat diets. Different fat level will affect the absorption and distribution of~     tocotrienols~   "
142781|NCT01185756|"~     The aim of the study is to assess the cardiac innervation in patients with heart failure to~     better select candidates for an implantable cardioverter defibrillator. Cardiac innervation~     will be assessed using an imaging agent administered intravenously.~   "
142782|NCT01185743|"~     Schizophrenia is a severe chronic and disabling mental disorder and is associated with a~     significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be~     jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid~     metabolism.~      Aim: to gain data on drug related effects on gene expression and regulation with special~     regard to glucose metabolism.~   "
142783|NCT01185730|"~     The objective of this clinical research is to analyze the survival of a cohort of patients~     newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of~     anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic~     factors using a dynamic model for predicting survival, including prognostic factors~     evaluated repeatedly at pre-specified periods during follow-up. In a second step, the~     investigators define using this model combinations of parameters to better define the~     therapeutic goals in PAH (functional class, exercise testing, hemodynamic, echocardiographic~     variables, biological parameters).~   "
142784|NCT01185717|"~     The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple~     sclerosis (MS) participants.~   "
142785|NCT01185704|"~     This is a randomized open-label study to compare between in-vitro~     fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of~     Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of~     the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in~     assisted reproductive technology (ART).~   "
142786|NCT01185691|"~     The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in~     Acute Decompensated Heart Failure patients.~   "
142787|NCT01185678|"~     Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand~     noncompliance seemed to be an inseparable element of any oral treatment. The aim of the~     study is to evaluate in everyday practice the relation between dosage errors and indicated~     factors, potentially influencing the compliance with the dosing scheme.~   "
142788|NCT01185665|"~     The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve~     Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are~     suffering of neuropathic pain at the lower back and leg after spinal surgery with a~     predominance of pain in the leg.~   "
142789|NCT01185652|"~     Tobacco-smoking causes lung function decline with airflow obstruction, which may be~     accelerated in persistent smokers.This would eventually lead to chronic obstructive~     pulmonary disease (COPD), a leading cause of morbidity and mortality in Hong Kong and~     globally. Lung function decline is gradual and not appreciated by the smoker until damage is~     advanced, and often under-recognised in the early stages of disease by healthcare providers.~     Spirometry is an established lung function measurement tool, and the most simple objective~     method to detect lung function decline. There is literature suggesting that newer~     spirometric parameters, FEV3 and FEV6, which are easier to achieve in the measurement~     process than conventional parameters, are comparable alternatives in detecting lung function~     decline.~      The aims of this study are:~        1. to evaluate and compare lung function decline in persistent smokers and non-smokers~        2. to study the usefulness of FEV3/FVC and FEV1/FEV6 in detecting lung function decline~        3. to correlate symptom scores with lung function parameters~        4. To correlate serum biomarker levels with respiratory symptoms and lung function~          parameters in smokers and non-smokers~      This is a follow-up study on a territory wide cohort including smokers and non-smokers, who~     have undergone lung function testing in 2001-03. Subjects will be invited to have repeat~     lung function assessment.~      The hypotheses of this study are:~        1. smokers have significantly greater decline in lung function compared to non-smokers in~          Hong Kong Chinese;~        2. newer lung function parameters are useful alternatives in detecting lung function~          decline~        3. serum inflammatory biomarker (IL-8, TGF-β, MMP9, TIMP-1, CRP) levels correlate with~          respiratory symptoms and lung function parameters in smokers when compared with~          non-smokers~   "
142790|NCT01185639|"~     This protocol is a single arm phase II multi-center trial evaluating the efficacy of~     Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell~     lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line~     chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line~     chemotherapy is feasible, safe, provides durable local control of treated lesions and~     improves time to progression compared to historical controls. Patients are eligible for~     enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.~   "
142791|NCT01185626|"~     Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer~     survivors. Nevertheless, these patients remain at risk for adverse long-term or late~     physical or psychosocial effects of cancer and its treatment. There is increasing~     recognition to improve information disclosure and cancer survivorship care. The American~     Institute of Medicine (IOM) and Health Council of the Netherlands both recommend that cancer~     survivors receive a summary of their course of treatment as a formal document, that also~     includes recommendations for subsequent cancer surveillance, management of late effects, and~     strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence~     exists concerning the positive and negative effects of the implementation of the SCP in~     daily clinical practice. The purpose of this study is to assess the impact of SCP care in~     routine clinical practice on cancer survivors' satisfaction with information disclosure and~     care, quality of life, illness perception, and health care use.~   "
142792|NCT01185613|"~     The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by~     documenting the procedural parameters, major complications and recurrence of AF after~     ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial~     fibrillation.~      This study is an observational clinical study which is not based on any specific endpoints.~   "
142793|NCT01185600|"~     INTRODUCTION. Cell-derived microparticles (MP) are released in cell activation, apoptosis~     and other processes. MP derived from red cells (RMP) are known to be released from stored~     packed red blood cells (PRBC), and their number increases with storage time. This~     constitutes one aspect of the storage lesion. Adverse transfusion events are known to~     increase with time of PRBC storage. The explanation for this is not known.~      HYPOTHESIS. Based on their findings and those of others, the investigators propose to test~     the hypothesis that MP in stored PRBC contribute to adverse effects of transfusion.~     Specifically, MP in stored blood: (1) increase procoagulant activity, expression of~     pro-inflammatory mediators, immune suppression, and endothelial disturbance; and (2)~     increase the risk of transfusion and post-operative complications in patients undergoing~     coronary artery bypass grafting (CABG).~      AIMS & PROCEDURES. The aim of this study is to assess the clinical significance of MPs in~     PRBC-related transfusion complications utilizing washed PRBC. Packed red blood cells (PRBC)~     will be washed at the blood bank to obtain MP depleted PRBC (PRBC-MP). A total of 500~     patients undergoing CABG will be initially randomized to 2 groups: one to receive PRBC-MP,~     and the other conventional PRBC (PRBC+MP). Using a panel of lab tests/biomarkers selected~     for high sensitivity the investigators will compare the 2 groups with respect to subclinical~     physiologic host responses including (i) endothelial disturbances, (ii) inflammatory, and~     (iii) procoagulant responses. In addition, clinically evident transfusion complications and~     short term (<=30 days) surgical complications will be assessed and compared. Patients who~     are randomized but end up not requiring transfusion at surgery will serve as controls.~     Laboratory and clinical results will also be evaluated to elucidate which tests are~     significantly associated with clinically adverse effects.~      SIGNIFICANCE. This study will shed new light on the biochemical and clinical effects of~     transfusion of MP. The findings of this investigation could significantly improve~     transfusion practice and safety.~   "
142794|NCT01185587|"~     The purpose of this research is to see if investigators can detect truncated mRNA splice~     variants of the cardiac voltage-gated sodium (Na+) channel gene, SCN5A, in patients with a~     weak heart (Heart Failure) with or without an implantable cardioverter-defibrillator (ICD)~     and compare them to patients with a normal heart.~      Hypothesis:~        1. Patients with reduced left ventricular ejection fraction have increased abundances~          truncated mRNA splice variants of the SCN5A gene, which portends to sodium channel~          dysfunction and an increased risk for sudden cardiac death.~        2. Patients with implantable cardioverter-defibrillator devices (ICDs) who have~          experienced shock therapy have increased abundances of truncated mRNA splice variants~          of the SCN5A gene compared to similar congestive heart failure patients who have not~          experienced shock therapy.~   "
142795|NCT01185574|"~     This study will examine whether weekly vitamin D supplementation in women with significant~     depressive symptoms and diabetes will exhibit improved mood and metabolic control. If~     supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method~     for treatment. Women will be targeted since they have greater depression and worse metabolic~     control than men with diabetes.~   "
142796|NCT01185561|"~     This proposal describes a small randomized study to determine whether usual medical care~     (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for~     diabetes alone. This program differs from other diabetes programs by focusing on the~     management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes~     self-care behaviors will be discussed and measured, but they are not the primary focus of~     the intervention. The psychoeducational program will address: 1) education about how~     dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3)~     management of dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be~     randomized to receive the group psychoeducational intervention or no additional treatment.~     All subjects will receive UMC for diabetes.~   "
142797|NCT01185548|"~     The purpose of this study is to assess the effect of tasisulam as an inhibitor of CYP2C9,~     using tolbutamide as a probe substrate. This study is comprised of three treatment periods,~     and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3~     are approximately 28 days in length.~   "
142798|NCT01185535|"~     As reported, about 0.43% patients can not be intubated unevenly because of difficult airway~     and 30% of the total death of anesthesia due to failed intubation. The difficult airway will~     disturb the clinical treatment and even threaten the patients' life. But the present methods~     for tracheal intubation during awake intubation can not provided ideal intubation condition.~     In this study, the investigators will perform topical anesthesia with the nebulized 2%~     lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation~     (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and~     remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial~     pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood~     samples were taken to measure stress factor during intubation period.Intubation condition~     score was assessed and the complications like local anesthetic toxicity, mucosa injury,~     respiration depress were also recorded. Patients were asked whether they could recall the~     events during intubation 24 hr after operation. The investigators aim is to evaluate the~     effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during~     awake tracheal intubation.~   "
142799|NCT01185522|"~     This prospective, observational study will assess the effect of RoActemra/Actemra~     (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have~     an inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor~     necrosis factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to~     the standard of care will be followed for 4 months.~   "
142800|NCT01185509|"~     The purpose of this research study is to see what effects trastuzumab in combination with~     vinorelbine has on breast cancer when the participant has circulating tumor cells that are~     positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2.~     The drug combination of trastuzumab and vinorelbine is an effective treatment for patients~     with breast cancers that are positive for HER2. This trial seeks to determine if the~     combination can also benefit participants whose original breast cancer was HER2 negative but~     whose circulating tumor cells are HER2 positive.~   "
142801|NCT01185496|"~     The purpose of this study is to evaluate the safety and effectiveness of the G4 System when~     worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1~     diabetes mellitus.~   "
142802|NCT01185483|"~     Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of~     superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of~     submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a~     high degree of endoscopic skills to be performed safely, it is time consuming, and less safe~     than endoscopic mucosa resection.~      New endoscopic instruments have been developed to increase the efficacy and safety of ESD,~     and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with~     promising results in animal studies. This HybridKnife allows high-pressure water-jet~     (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without~     changing instrument.~      The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for~     ESD in humans.~   "
142803|NCT01185470|"~     • The objectives of this study are to confirm the medication delivery accuracy of the~     Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled~     Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine~     the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for~     pain control.~   "
142804|NCT01185457|"~     The Left interscalene block has a different effect on heart's autonomic nervous system, as~     measured with Heart Rate Variability, compared to Right interscalene block~   "
142805|NCT01185444|"~     Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide~     rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function~     in patients with knee osteoarthritis. The treatment effects can last for 6 months.~   "
143017|NCT01182636|"~     The objective of this study was to evaluate the efficacy and safety of the test formulation~     of adapalene gel 0.1% (PLIVA Research & Development Ltd.) as compared to the already~     marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in~     patients with acne vulgaris.~   "
142806|NCT01185431|"~     This trial is being conducted to look for following changes when fig paste is taken by~     female subjects with functional constipation:~      To evaluate the improvement of the bowel~      To assess the quality of life and impact on female reproductive function~      To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol~   "
142807|NCT01185418|"~     The aim of the study is to investigate the negative symptoms and cognitive function after~     administration of antipsychotics in healthy volunteer.~   "
142808|NCT01185405|"~     Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive~     fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring~     of voriconazole has been issued because of wide variations and unpredictability of~     voriconazole blood concentration. The objective of this study is 1) to characterize the~     pharmacokinetics of voriconazole in ICU patients on voriconazole prophylaxis or treatment,~     and 2) to develop and evaluate the prediction and adjustment models for voriconazole plasma~     levels.~   "
142809|NCT01185392|"~     The European CRT survey represents a joint initiative between two ESC associations; the~     Heart Failure Association and the European Heart Rhythm Association. The survey will be~     performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which~     will handle the data collection and data analysis.~   "
142810|NCT01185379|"~     Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated~     with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et~     al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic~     acid (DHA) on behavioural outcomes in older adults has been explored, however two trials~     addressing this issue have published conflicting results regarding the efficacy of DHA~     supplementation, with one reporting a benefit of treatment on cognitive performance~     (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).~      One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs~     on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination~     with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The~     current study will explore several separate hypotheses within the same cohort. These are~     that Efalex Active 50+ may have a beneficial effect on:~        -  Cognitive performance~        -  Mental fatigue in response to cognitively demanding tasks~        -  Self-reported mood/well-being~        -  Task-related cerebral blood flow response~      The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and~     mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of~     potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12,~     folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70~     years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the~     same treatment formulation in a sample drawn from the same population, with the addition of~     a third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.~   "
142811|NCT01185366|"~     The goal of this clinical research study is to compare the effectiveness of Afinitor~     (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma~     (kidney cancer). The safety of each treatment will also be studied.~   "
142812|NCT01185353|"~     The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in~     participants with Rheumatoid Arthritis (RA).~   "
142813|NCT01185340|"~     The primary objective of this study is to assess whether LY2216684 12 mg to 18 mg flexible~     dose once daily is superior to placebo Once Daily in the adjunctive treatment of patients~     with major depressive disorder (MDD) who are partial responders to their Selective Serotonin~     Reuptake Inhibitor Treatment (SSRI).~   "
142814|NCT01185327|"~     Nursing team of well baby nursery at Hillel Yaffe medical center in Hadera, Israel have~     noticed that infant of Ethiopian-origin mothers regurgitate more than other infants.~     Probably, these infants are breastfeed much more than other infants.~      Some Ethiopian-origin mothers are used to eat teff-flower porridge during the last weeks of~     pregnancy and after birth, in order to expand milk production.~      Study goal is to find out if infants of Ethiopian-origin mother do regurgitate more than~     others, and if they weight gain is similar to other infants. Another goal is to find out if~     breastfeeding mothers of Ethiopian origin do eat that porridge, and if there is any~     difference between those who do eat that porridge and those who do not.~   "
142815|NCT01185314|"~     The purpose of this study is to study the changes in protein in lung cells of Asian patients~     with advanced non small cell lung cancer.~   "
142816|NCT01185301|"~     The purpose of this study is to determine the effects of different doses of methotrexate~     (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).~   "
142817|NCT01185288|"~     This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in~     combination with open-label adalimumab (ADA) in patients who have had an inadequate response~     to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two~     regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).~   "
142818|NCT01185275|"~     Clinical response, as defined by improvement in asthma quality of life, to bronchial~     thermoplasty in patients with severe refractory asthma can be predicted through the use of~     clinical, physiologic, biologic and imaging markers.~   "
142819|NCT01185262|"~     The rationale for combining lenalidomide with rituximab derives from preclinical~     observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular~     cytotoxicity) triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK~     cytotoxicity by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These~     results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant~     in immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The~     combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on~     CLL cell lines. However the observed synergism was attributed to NK cells expansion, thus~     lending support to the notion that this synergism may operate in other B-cell~     lymphoproliferative malignancies.~      The objective was to develop a non-cytotoxic and effective treatment for CLL that would~     fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and~     frail. These patients experience an excess in chemotherapy induced toxicity, often~     preventing the completion of the planned treatment.~   "
142820|NCT01185249|"~     Early morning weights to monitor CHF patient's fluid status is common practice but there is~     a lack of evidence that this is the best practice. The purpose of this study is to determine~     if there is a difference in net weight gain or loss for hospitalized patients with CHF who~     are weighed in the evening instead of early morning.~   "
142821|NCT01185236|"~     A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin~     10/20mg vs atorvastatin 20mg treatment.~      DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be~     randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout~     or TLC period. Primary and secondary endpoints will be assessed at week 12.~      Primary endpoint:~      1) change of ApoB/ApoA ratio at week 12.~      Secondary endpoint:~        1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.~        2. Change of HbA1C at week 12.~        3. Change of HOMA index at week 12~           - HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5~        4. Change of hsCRP at week 12~        5. Safety assessment~      Hypotheses:~        -  Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in~          ApoB/ApoA ratio.~        -  In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.~   "
142822|NCT01185223|"~     The objective of this study is to assess the efficacy and safety of oral valganciclovir~     versus intravenous ganciclovir in patients following allogenic stem cell transplantation.~   "
142823|NCT01185210|"~     Background:~      Over the past few decades, fructose is increasingly being used as a sweetener/ additive in a~     variety of foods. Incomplete absorption of fructose has been implicated as a cause of~     gastrointestinal symptoms. In tertiary care centers, the prevalence of fructose~     malabsorption in subjects with unexplained GI symptoms is thought to be between 11-50%, when~     assessed with breath tests following administration of 25 grams of fructose in a 10%~     solution. Restriction of dietary fructose has been shown to improve symptoms in these~     patients to an extent. Currently, there are no therapeutic agents that improve intestinal~     fructose absorption and thereby decrease symptoms. Studies in the pediatric population have~     shown that fructose absorption in the small intestine is increased in the presence of~     glucose or amino acids, especially alanine.~      Objective:~      The investigators' objective is to assess whether co-administration of an oral solution of~     L-alanine facilitates fructose absorption and decreases gastrointestinal (GI) symptoms~     associated with fructose malabsorption in subjects undergoing standard fructose breath test~     when compared to placebo.~      Methods and analysis:~      The investigators propose a randomized, double-blind study in 40 subjects with known~     fructose intolerance. After an overnight fast, each subject will receive an oral solution of~     12.5 grams of alanine in 125cc of water or placebo. Next, the subject will receive an oral~     solution of 25 grams of fructose in a 10% solution. Serum, urine and breath samples will be~     collected at baseline and at 30-minute intervals for 4 hours. GI symptoms will also be~     assessed and recorded at 30 minute intervals using a standard questionnaire. Repeated~     measures ANOVA will be used to compare the data obtained during the study protocol with the~     baseline (pre-study) data.~      Expected outcomes:~      Co-administration of alanine with fructose may improve fructose absorption and decrease~     symptoms in subjects with fructose intolerance.~      Hypothesis: Ingestion of alanine along with fructose, will facilitate intestinal absorption~     of fructose in subjects with fructose malabsorption.~      Aim: To investigate the effects of co-administration of equi-molar doses of alanine on a)~     the absorption of fructose and b) the occurrence of GI symptoms in subjects with fructose~     malabsorption.~   "
142824|NCT01185197|"~     Study objective: To investigate the potential therapeutic efficacy of enteric-coated~     mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for~     minimal change nephrotic syndrome (MCNS).~   "
142825|NCT01185184|"~     This study will explore the drug behavior and safety following single dose of two 20~     milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a~     10 milligram immediate release tablet, using a 3 way crossover design.~   "
142826|NCT01185171|"~     The purpose of this study is to explore the activity of ZD1839 added to concurrent~     chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and~     neck cancer. Activity is described in terms of response rate (complete responses only).~   "
142827|NCT01185158|"~     The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's~     squamous cell head and neck cancer. The research is being done because currently no~     effective treatment exists for metastatic (spread of cancer cells from one area of the body~     to another) or recurrent squamous cell cancer of the head and neck. The purpose of this~     study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a~     period of time.~   "
142828|NCT01185145|"~     Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is~     safe and effective in patients with early stage breast cancer resected by lumpectomy.~   "
142829|NCT01185132|"~     In the setting of radiotherapy as part of breast-conservation therapy for patients with~     early stage breast cancer, the novel planning and delivery method of intensity modulated~     radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal~     external beam radiotherapy, spares more normal breast and lung tissue, and may lead to~     improved clinical outcomes.~   "
142830|NCT01185119|"~     10 healthy men will be PET-scanned (CNS) twice in random order with infusions of placebo or~     Native GLP-1 during hyperglycemic clamp to uncover the metabolic effects of GLP-1 in~     perspectives of intervention of macrovascular late diabetic pathology such as stroke and~     AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS~     despite fluctuations in blood sugar when infusing native GLP-1.~   "
142831|NCT01185093|"~     The main objectives of the study is to~        -  Evaluate the knowledge acquisition and retention of 4th-grade students who participate~          in the St. Jude Cancer Education for Children Program~        -  To examine the relationship between outcome measures (knowledge acquisition and~          knowledge retention) with covariates of interest such as self-reported age and gender~        -  To compare the knowledge scores among schools and identify the schools that may show~          better improvement than others and factors associated with improvement~   "
142832|NCT01185080|"~     The primary purpose of this study is to investigate effect, tolerability and safety of~     different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis~     patients out of season in an allergen challenge model.~   "
142843|NCT01184937|"~     For patients with end-stage kidney disease, transplantation is the treatment of choice,~     offering improved quality of life by restored metabolism and freedom from dialysis. However,~     demands regarding the acquirement of knowledge in life post transplantation are high. In~     order to reduce rejection episodes, graft loss and the negative consequences of life-long~     immunosuppressive medication, it is essential for kidney recipients to possess knowledge~     about important aspects regarding immunosuppressive medication, graft surveillance and the~     benefit of specific lifestyle behavior. Consequently, patient education is required for this~     patient group. This randomized controlled trial is investigating the effect of a structured~     patient education program on kidney recipients' knowledge, coping and quality of life~   "
143189|NCT01180400|"~     The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like~     medicine tablet or capsule, but contains no active medicine) is safe and effective when~     taken together with another antidepressant.~   "
142833|NCT01185067|"~     Diastolic heart failure (also known as heart failure with normal ejection fraction or~     heart failure with preserved ejection fraction) occurs even though the heart muscle's~     pumping function is normal. In many cases diastolic heart failure is related to stiffening~     of the heart and blood vessels in people who have high blood pressure. Current guidelines~     suggest that patients should limit the salt content of their diet, as too much salty food~     can cause fluid retention and other problems in diastolic heart failure. Studies in animals~     with diastolic heart failure suggest that antioxidant chemicals found in grapes can block~     some of the harmful effects of salty diets. Because it is often difficult for patients with~     diastolic heart failure to maintain a low salt diet, the investigators are researching the~     effects of the antioxidant properties of grape seed extract, a natural supplement made from~     grape seeds. The investigators hypothesize that supplementing the diet with grape seed~     extract (GSE) can decrease the levels of harmful chemicals and improve heart and blood~     vessel function in patients with diastolic heart failure and a history of high blood~     pressure.~      The University of Michigan research group plans to enroll 25 patients with a history of high~     blood pressure and diastolic heart failure in a research study. The study will assess the~     effects of GSE on hormones and other chemicals that can cause heart and blood vessel damage.~     The investigators will also study the effects of GSE on the ability of the blood vessels and~     heart muscles to relax at the proper time and speed. Finally, the investigators will observe~     how GSE affects participants' overall ability to exercise, quality of life, and blood~     pressure control. Study participants will be randomly assigned to take either GSE or placebo~     (looks like but does not contain GSE) capsules twice a day for six weeks. After a two-week~     break, all subjects will cross over to the opposite group of capsules for an additional~     six-week period. At the start of the study and at the end of each six-week time period study~     participants will have non-invasive heart and blood vessel testing, blood work and urine~     tests, and blood pressure monitoring.~   "
142834|NCT01185054|"~     The objective of this study is to clarify the current standard of care by determining if~     Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk~     children who present to an Emergency Department (ED) with < 72 hours of vomiting or~     diarrhea.~   "
142835|NCT01185041|"~     Increased abdominal obesity (waist circumference) and systolic blood pressure (BP) are main~     risk factors for the metabolic syndrome. Approximately 60% of adults in the United States~     are prehypertensive or hypertensive. Hypertension has been associated with abnormal~     endothelial and autonomic function, the two main mechanisms of BP regulation. Endothelial~     dysfunction, as a result of reduced NO (a vasodilator), and increased sympathetic nervous~     system activity contribute to arterial stiffness by enhancing the vasomotor tone. Because BP~     variations are sensed by baroreceptors in the wall of large arteries, increased stiffness of~     arteries may attenuate the control of BP by the autonomic nervous system leading to~     hypertension. High production of proinflammatory cytokines and low adiponectin (vascular~     protective molecule), are considered the underlying mechanisms leading to endothelial~     dysfunction and arterial stiffness. The recommended intervention for controlling BP in~     overweight/obese individuals with pre- and stage 1- hypertension is lifestyle modifications~     and not drug therapy. Among the dietary regimens that are reported to reduce BP is~     L-arginine, the substrate for endothelial NO production. Recently, oral L-citrulline has~     been shown to be more effective than L-arginine in improving circulating NO levels because~     is not affected by enzymatic degradation. Watermelon, the leading US melon crop, is one of~     the few natural foods rich in L-citrulline which is efficiently transformed to arginine in~     humans. The investigators long-term goal is to provide feasible and effective dietary ways~     to reduce cardiovascular risk factors in individuals with high abdominal fat and BP. The~     overall objective of this study is to bring forth evidence that watermelon supplementation~     will reduce BP and cardiovascular risk factors such as arterial stiffness, autonomic~     dysfunction and endothelial dysfunction. The investigators postulate that watermelon~     supplementation will reduce BP and arterial stiffness by enhancing endothelial function and~     reducing vascular inflammation. The findings of this study will provide a foundation for~     disseminating feasible, safe approaches for preventing and combating obesity-related~     hypertension at its early stage which does not require drug therapy.~   "
142836|NCT01185028|"~     Background:~        -  Chronic hepatitis C (CHC) is a major health problem that particularly affects~          individuals with human immunodeficiency virus (HIV) infection, and can lead to~          cirrhosis and liver failure. Standard treatment for people with HIV and CHC is a~          48-week course of pegylated-interferon alfa 2a (peg-IFN) and ribavirin (RBV), but~          better treatments are needed for those who either do not respond to the drugs or who~          relapse after treatment.~        -  Nitazoxanide has been approved by the Food and Drug Administration primarily to treat~          diarrhea caused by parasites, and it has been studied in the treatment of CHC~          infection. However, it has not been tested in persons infected with HIV and CHC~          co-infection. Researchers are interested in determining whether nitazoxanide is a safe~          and tolerable treatment for CHC in individuals with HIV.~      Objectives:~      - To assess the safety and tolerability of using nitazoxanide to treat chronic hepatitis C~     infection in individuals with HIV who have not responded to standard treatment for hepatitis~     C.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with both HIV and chronic~     hepatitis C, and who have either not responded to or relapsed after previous hepatitis C~     treatment.~      Design:~        -  Participants will be screened with a physical examination and medical history; blood~          and urine tests; imaging studies; possible heart, lung, and psychological tests; and a~          liver biopsy if one has not been done in the past 3 years.~        -  Participants will receive nitazoxanide, the medication being studied, to take by mouth~          for 4 weeks, and will provide blood samples during this time.~        -  After 4 weeks, participants will receive the first dose of peg-IFN and RBV.~          Participants will have weekly injections of peg-IFN and continue to take nitazoxanide~          and RBV by mouth for 48 weeks. Individuals who are slow to respond to this combined CHC~          treatment (nitazoxanide, peg-IFN, and RBV) by week 12 will continue to have the~          combined treatment for an extended period, a total of 72 weeks.~        -  Participants will have study visits to provide blood samples and have other tests two~          times in the first month of combined treatment, and then at months 2, 3, 4, 7, 10, 13,~          19; and month 25 only in participants slow to respond to combined treatment.~        -  Some participants who are on specific HIV treatment regimens may enroll in a substudy~          that will require three separate 12-hour visits for repeated blood samples and other~          tests during the initial 4-week nitazoxanide treatment.~   "
142837|NCT01185015|"~     The multi-centric, open label, single arm and self controlled study is planned to assess the~     efficacy of orally administered Sigmart in subjects with recurrent angina after coronary~     revascularization. The primary objective of this study is to demonstrate that orally~     administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent~     angina subjects.~   "
142838|NCT01185002|"~     The purpose of the study is to test the effect of a bowel preparation and boosts regimen on~     PillCam® procedure, colon cleanliness and capsule excretion time.~   "
142839|NCT01184989|"~     To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on~     coagulation parameters, including a calibrated thrombin time test, in patients with moderate~     renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD~     study will be conducted.~   "
142840|NCT01184976|"~     Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase~     (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult~     males by IM injection followed by EP will be generally well tolerated and immunogenic.~   "
142841|NCT01184963|"~     The objective of this study is to assess the effects of a high protein (HP) and a normal~     protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index~     (BMI)-matched controls in a sample of southern Brazilian women.~      Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30%~     lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.~      The investigators hypothesis is that a different diet composition may have influences in~     changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.~   "
142842|NCT01184950|"~     The use of virtual reality simulation training in obstetrics and gynecology has not been~     widely studied. The investigators hypothesized that residents randomized to the trainer~     would not perform differently when compared with those who are not randomized. Residents in~     Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They~     are objectively evaluated performing various laparoscopy tasks prior to and after the~     course.~   "
142893|NCT01184287|"~     The purpose of the trial is to determine the rate of improvement in objective tumor~     response, following the addition of ranpirnase to ongoing pemetrexed—carboplatin~     chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.~   "
142844|NCT01184924|"~     The primary goal of this study is to assess the effectiveness and feasibility of the~     arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most~     prevalent chronic condition in the US and a leading cause of disability, is characterized by~     chronic pain and progressive impairment of joints and soft tissues. Promoting physical~     activity is a key public health strategy to addressing arthritis management, but more~     scientific data regarding effectiveness and feasibility are need to support the promotion of~     the AF Tai Chi Program as an exercise intervention for people with arthritis.~   "
142845|NCT01184911|"~     The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in~     pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised~     by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to~     asymptomatic parasitemic pregnant women and following them to determine the rates of~     parasite clearance.~   "
142846|NCT01184898|"~     The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard~     chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML).~     Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin~     is affecting the mTOR pathway in the cells and if this effect is correlated with how well~     patients respond to the therapy.~   "
142847|NCT01184885|"~     This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian~     target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD~     (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an~     ultimate goal to perform a phase II study to evaluate response rates and survival in adults~     with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.~   "
142848|NCT01184872|"~     The purpose of this study is to provide data documenting the efficacy of daptomycin in~     elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.~   "
142849|NCT01184859|"~     This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group~     comparative trial to be conducted in nocturia patients. The trial is designed to~     characterize the dose-response relationship of Minirin (desmopressin) Melt in order to~     establish correct dose recommendations in the target patient population. In particular, the~     trial is designed to link the duration of action to the clinical endpoint. Furthermore, the~     trial is designed to describe the safety of four different dose levels of desmopressin.~   "
142850|NCT01184846|"~     The objective of this study is to demonstrate the efficacy and safety of Privigen in~     subjects with CIDP.~   "
142851|NCT01184833|"~     Non-adherence to the treatment regimen is a common problem associated with injectable drugs~     (e.g. Betaferon) that are used in multiple sclerosis patients.~      Certain patients omit single injections or even totally discontinue therapy that normally~     should be long-term. It is therefore crucial to identify the factors which have the most~     significant effect on regularity of administration of Betaferon and the risk of premature~     discontinuation of treatment in order to undertake appropriate preventive measures.~      This study is conducted in routine practice setting and aims to identify those risks.~     Pre-defined risk factors associated with technical aspects of the treatment, support~     provided to the patient, stage of the disease and possible adverse effects of the medication~     are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of~     the prescribed medication (Betaferon) is carried out by the study nurse.~   "
142852|NCT01184820|"~     The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test~     drug). Pharmacokinetics means that we will measure how well the study drug corrects the~     factor VIII levels in your blood and how long it takes for the levels to fall back to your~     baseline level. The study is also designed to determine if the pharmacokinetics of~     BAY94-9027 change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe,~     tolerable, and effective for the treatment of severe hemophilia A and define the appropriate~     dose of BAY94-9027. Two doses of BAY94-9027 will be studied.~      The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and~     will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort~     2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses).~     All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by~     measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII~     blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see~     describe the PK. Safety & tolerability assessment include vital signs, coagulation and~     hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene~     glycol (PEG) antibodies will be done during the course of the study.~   "
142853|NCT01184807|"~     This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid~     tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10,~     20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the~     MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the~     safety profile and antitumor effect of OPB-51602 at the recommended dose.~   "
142854|NCT01184794|"~     This study is a blinded randomised study of slow release levobupivacaine vs saline for women~     undergoing day case operative pelvic laparoscopy. Participants will be randomly given either~     saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and~     rescue oral analgesia use.~   "
142855|NCT01184781|"~     The aim of the study is to perform a prospective, multicenter research comparing capsule~     endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer~     specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic~     accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and~     a high resolution colonoscope (with high definition). Both procedures will be perform in the~     same day with an adapted bowel preparation.~   "
142856|NCT01184768|"~     Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with~     lower hba1c values will be invited to an oral glucose tolerance test to see the predictive~     value of HBA1c in the diagnosis of type 2 diabetes.~   "
142894|NCT01184274|"~     This research is being done because SB939 has been shown to shrink tumours in animals and in~     some people and seems promising, but we are not sure if it can offer better results than~     standard treatment.~   "
142857|NCT01184755|"~     Although drug therapies have greatly improved blood pressure (BP) control and reduction of~     cardiovascular events, as many as 50% of hypertensives on drug treatment have inadequately~     controlled BP due to poor adherence, insufficiently aggressive treatment, and an aversion on~     the part of many patients to drug treatment. Device-guided breathing is a behavioral~     intervention that guides the breathing into the 6 per minute range, inducing respiratory~     sinus arrythmia (RSA), which is the natural cycle of arrythmia that occurs through the~     influence of breathing on the flow of sympathetic and vagus impulses to the sinoatrial node~     of the heart. It has been shown in several small trials to have substantial effects on BP~     reduction, has no known side-effects, and may represent a cost-effective adjunctive~     treatment for hypertension. an important consideration is that, often, behavioral~     interventions are given for a brief amount of time, but are expected to have long-term~     effects. This does not hold true for medication; one would not give anti-hypertensive~     medication for eight weeks and expect an effect on BP several months later. The development~     of behavioral interventions needs to take into account methods to sustain long-term effects.~      Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided~     breathing intervention on ambulatory BP (ABP) in hypertensives drawn from primary care and~     specialty hypertension practices, using a sample size powered to detect effects at 8 weeks~     and 4-month follow-up. We also propose to study a physiological mechanism, baroreflex~     sensitivity, that may mediate the effect of the intervention on BP. The design calls for two~     control groups: Usual Care (UC) and a relaxation placebo condition (using a device that~     gives the same type of feedback sounds as the guided breathing feedback device, but modified~     to pace the breathing at approximately 13 breaths per minute, a normal resting rate.) There~     are two intervention conditions using the RESPeRate device that guides the breath into the 6~     breaths/minute range. In both, the initial intervention lasts eight weeks, following which~     participants are further randomized to either: 1) ending the intervention; of 2) continuing~     the intervention for the next 8 weeks. The main outcomes are the change in systolic and~     diastolic BP (measured by Ambulatory BP monitoring) during the waking hours. Outcomes are~     measured at baseline, 8 weeks, and 16 weeks~   "
142858|NCT01184742|"~     The purpose of this study is to assess the relationship between physical fitness and~     wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers;~     and 3) self-reported avoidance of environmental features.~   "
142859|NCT01184729|"~     The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test~     (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap,~     wheelchair satisfaction, depression, and self-reported avoidance of environmental features.~   "
142860|NCT01184716|"~     Approximately 200 families corresponding to 800 persons are included in the study. The study~     investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in~     serum. Participants receive milk and bread twice a week. Half of the participants receive~     vitamin D fortified products and the other half similar non-fortified products. The study~     starts in September and runs for 6 months during winter, the period where it is not possible~     to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual~     fall in vitamin D status can be prevented by vitamin D fortified food.~   "
142861|NCT01184703|"~     The purpose of this study is to investigate if a low glycemic index diet in comparison with~     a medium/high glycemic index diet improves the metabolic control in patients with type 1~     diabetes.~   "
142862|NCT01184690|"~     Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment~     throughout the entire small intestine. Although the originally described method requires two~     operators, the investigators have recently developed a method to perform DBE by a single~     operator. The investigators here assessed the clinical usefulness of this one-person method~     in comparison to the conventional two-person DBE.~   "
142863|NCT01184677|"~     The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size~     would reduce the incidence of mucosal injury.~   "
142864|NCT01184664|"~     Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation~     treatments. Anecdotally smokers who are finding their quit attempt difficult have reported~     benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled~     double-blind study will examine whether combining NRT and varenicline provides better~     withdrawal and craving relief than varenicline alone. A total of 120 smokers would be~     randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All~     participants will receive standard NHS Stop Smoking Service support. The primary outcome~     would be ratings of craving and withdrawal discomfort 24 hours and one week after the target~     quit date.~   "
142865|NCT01184651|"~     The goal of this study is to help investigators to understand more about the development of~     characteristics related to being male or female (what is called gender development). The~     investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to~     learn more about the girls' interests and activities, thoughts and feeling about being~     female, and family relationships. This will help investigators to understand the ways in~     which gender development is shaped by hormones and family relationships.~   "
142866|NCT01184638|"~     Cognitive disorders in patients underwent general anesthesia are discussed for decades, but~     whether there were precise relationship between general anesthesia and dysgnosia is yet to~     be guaranteed. Although controversial data reported from experimental studies in animals,~     the investigators still proposed that general anesthetics could impair the normally~     organized system of the central nervous system, which finally displayed a dysfunction of~     cognition after general anesthesia in a short- or long-term period. Therefore, different~     types of general anesthetics such as inhalational anesthetics and intravenous anesthetics,~     the investigators hypothesized, had a long-term influence on patients' cognitive ability.~   "
142867|NCT01184625|"~     The objectives of this study are to test if hypoxia in muscle tissue is an important factor~     contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate~     if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in~     patients with chronic rheumatic muscle inflammation.~   "
142868|NCT01184612|"~     Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and~     alcohol use. A five session MI intervention (BSF) was implemented in the Swedish~     correctional system. The intervention was delivered by counsellors with workshop only MI~     training (BSF) or by counsellors with workshop MI training followed by peer group~     supervision based on audio taped feedback (BSF+).~      Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than~     interviews conducted according to the usual planning interview routine (UPI).~   "
142869|NCT01184599|"~     The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin~     inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA~     nephropathy.~   "
142895|NCT01184261|"~     RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and~     binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine~     patches with or without behavioral therapy in reducing cigarette smoking and binge drinking~     in young adults.~   "
142870|NCT01184586|"~     Dupuytren's disease is a progressive disease due to unknown causal agents or genetics.~      Dupuytren's disease contains nodules and cords in the fascia as the epicenter of disease~     progression. Nodules contain whorls of collagen bundles and are densely packed with~     contractile fibroblasts and myofibroblasts. These highly contractile cells are linked to the~     fascia matrix through transmembrane integrin receptors. The cytoplasmic tail domains of the~     alpha beta integrin receptors provide a structural link between extracellular matrix and the~     actomyosin cytoskeleton.~      Complications of surgical partial or total aponeurectomy in Dupuytren's disease are reported~     in up to 10% of cases . Often, surgical complications lead to compromised flexion limiting~     grasping function of the involved hand . A recent 20-year-review of the literature included~     41 clinical trials with complication rates reported from 3.6%to 39.1% . 16% major~     complications occurred with 3% digital nerve injuries, digital artery injuries in 2%,~     infections in 2%, and complex regional pain syndrome in 6%. Besides selective or total~     aponeurectomy, soft-tissue distraction has been suggested using either pneumatic devices or~     external fixateur .~      Non-invasive options include percutaneous fasciotomy or collagenase injection. The latter~     has been tested in a randomized-controlled trial published in the New England Journal of~     Medicine with 308 patients enrolled (NCT00528606) . Collagenase clostridium histolyticum~     significantly reduced contractures and improved the range of motion in joints affected by~     advanced Dupuytren's disease. In the long-term the cords at the level of the proximal~     interphalangeal joint appear to more recurrent than at the metacarpophalangeal joint after~     collagenase injection with an eight year follow-up .~      In early stage Dupuytren's contracture, radiotherapy has been suggested to limit disease~     progression. A cohort study of 135 patients with 208 hands involved received orthovoltage~     radiotherapy with a total dose of 30Gray separated by a six to eight week interval . After a~     follow-up of 13 years nodules and cords remained stable in 59%, improved in 10% and~     progressed in 31%.~      Beside Dupuytren's disease, there are a number of further less common fibromatosis, such as~     knuckle pads, M. Ledderhose , of the plantar fascia and peyronie disease at the penis. The~     latter has been treated by extracorporeal shockwave therapy. A randomized-controlled trial~     using 2000 focused shock waves reduced pain significantly and improved erectile function and~     quality of life . About half of the patients in one series of 44 patients had a significant~     reduction in angulation following shockwave therapy .~   "
142871|NCT01184573|"~     The goal of this study is to evaluate the feasibility of using a non-invasive,~     non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of~     chronic pancreatitis (CP). If successful, this method could have important advantages over~     existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have~     a clinical impact if it leads to early detection of CP and intervention to mitigate disease~     progression.~   "
142872|NCT01184560|"~     The purpose of this study, conducted academic Pilot research purposes, this is not clear as~     to permit. when orlistat to sibutramine merge if there are additional effects of BMI and~     group, which has an attribute that is greater for the combined effect is to analyze.~        -  Study phase: Investigator-initiated clinical study (Pilot study)~        -  Method of blinding: Double-blind~        -  Control: Placebo-controlled~        -  Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and~          Sibutramine combination group = 1 : 1)~        -  Studied disease: Obesity~        -  Study population: Subjects eligible for inclusion/exclusion criteria~        -  Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and~          post-dosing observation period (4 weeks)~   "
142873|NCT01184547|"~     The purpose of this proposal is to assess the efficacy of implementing a 12-week structured~     and supervised community-based exercise program (COMBEX) at hospital discharge. The~     investigators will assess the effect of exercise on mental health and physical function,~     along with its effects on the amelioration of the burn-induced catabolic response.~      The central hypothesis of this proposal is that exercise-induced physical and psychosocial~     benefits obtained during a supervised and structured COMBEX program in severely burned~     adults will improve physical function, and quality of life relative to Standard of Care~     (SOC).~   "
142874|NCT01184534|"~     Objective:~      To compare changes in patient anxiety levels between groups of patients who either were or~     were not exposed to an informative multimedia patient education tool, in order to determine~     how the addition of such a multimedia tool will affect this parameter. Specifically, the~     study will focus on subjective anxiety as measured on pre procedure and post procedure~     patient surveys as detailed under study components.~   "
142875|NCT01184521|"~     This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in~     monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.~   "
142876|NCT01184508|"~     The primary objective of this study is to measure the change in frequency of migraine~     attacks per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.~   "
142877|NCT01184495|"~     A double-blind, randomized trial aimed to compare the efficacy of two formulations of~     erythropoietin in patients with chronic renal failure on hemodialysis~   "
142878|NCT01184482|"~     This trial is for patients with colon cancer, head and neck cancer and lung cancer that has~     not responded to standard therapy.~      Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or~     EGFR. It is thought that this receptor is turned on in some cancers, enabling cancer cells~     to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this~     receptor from the outside of cancer cells. It is thought that cancer cells can turn this~     signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks~     both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been~     found that combining drugs that target both EGFR and ErbB2 might work better in turning this~     signal back off. The purpose of this study is to determine the maximum dosages that patients~     can tolerate when these two medicines are given at the same time.~      In addition, in order to be on this trial, patients must agree to have a tumor biopsy before~     starting treatment on this study and 21 days after starting treatment. These biopsies are a~     required part of the study. Patients must also agree to have blood drawn for research~     testing to see whether genetic differences between patients explain different reactions to~     and side effects from, these medicines.~   "
142879|NCT01184469|"~     The purpose of this study is to prospectively define a set of data suitable for developing~     models of pregnancy viability. Those models will be based on serum hCG concentration~     measured during the peri-implantation period in patients that received fresh embryo transfer~     and those that received transfer of frozen-thawed embryos, and to compare and contrast these~     models. This may reveal insights into differences between these types of IVF cycles.~   "
142880|NCT01184456|"~     Improvement in the rate of bacterial translocation may lead to a decrease in a chronic~     inflammatory response thereby decreasing CD4 destruction and HIV proliferation.~      By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in~     chronic inflammation and therefore an improvement in immune markers.~   "
142921|NCT01183910|"~     A randomized, double-blind, placebo controlled study to assess the safety and effectiveness~     of a novel oral natural extract to improve the appearance of the skin of patients with~     senile purpura.~   "
142881|NCT01184443|"~     The purpose of this trial is to evaluate the safety and efficacy of the atypical~     antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).~      Adolescent males and females between the ages of 11 and 17 years who are being treated by a~     physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be~     invited to join the study if they have been diagnosed with AN or Eating Disorder Not~     Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body~     weight. Those who meet inclusion and not exclusion criteria, and consent to participating in~     the trial will be offered adjunctive treatment with olanzapine. Those who agree to take~     olanzapine will belong to the olanzapine group, and those who decline will belong to the~     comparison group. Olanzapine doses will be in keeping with the investigators current~     clinical practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of~     patients are treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on~     individual need and tolerability. Participants will remain in the study for 12 weeks. Those~     who initially decline olanzapine treatment may change their minds and take olanzapine up~     until week 9 of the trial.~      It is hypothesized that those children and adolescents who choose to take olanzapine at~     entry into the trial will be more motivated to recover and more compliant with treatment.~     Compared to those who do not receive medication, it is expected that these adolescents will~     demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate~     of weight gain.~      Finally, it is predicted that the rates of discontinuation and the adverse effects of~     olanzapine will be minor given the relatively low dose (as compared to treatment for~     patients with schizophrenia), slow titration, and short-term use of olanzapine the~     investigators will be using.~      By comparing the well-being and outcome of patients in the two groups, the investigators~     hope to begin to answer the question of whether olanzapine does or does not lead to improved~     clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the~     question of whether the benefits of using the medication outweigh the risks.~   "
142882|NCT01184430|"~     Cardiac surgery patients have a high risk to suffer from postoperative infections. Some~     studies have shown, that humoral and cellular factors are associated with perioperative~     immunodysfunction and can increase the risk of postoperative infections. Monocytes in the~     blood and, especially alveolar macrophages are important for an adequate host defence. In~     studies the investigators have shown that hemodynamic parameters have a significant~     influence on the probability to develop postoperative infections. The aim of the study is to~     investigate, whether cardiac surgery patients have an altered immune function after surgery~     that is predictive for the latter development of subsequent infections and whether they~     benefit from a goal-directed volume and hemodynamic therapy.~   "
142883|NCT01184417|"~     Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based~     alcohol withdrawal protocol will be associated with decreased need for ICU admission,~     continuous lorazepam infusion and will not be associated with increased adverse events.~   "
142884|NCT01184404|"~     Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with~     and without congenital heart disease (CHD). However, cardiac surgery involves many risks of~     complications, such as bleeding, arrhythmias, and death.Right ventricular failure is another~     complication, contributing to poor clinical outcome. Right ventricular failure is a clinical~     syndrome, often difficult to treat, characterized by edema, elevated jugular venous~     pressure, oliguria, hypotension, and in severe cases shock, multi organ failure and death.~     Patients with CHD and patients with mitral valve lesions are suspected to be at increased~     risk for developing right ventricular failure post-operatively. In addition, other clinical~     factors contributing to right ventricular failure are mechanical pulmonary ventilation,~     pulmonary hypertension and cardiac surgery. Right ventricular failure during cardiac surgery~     is caused by the cardiopulmonary bypass by reperfusion with high partial pressures of~     oxygen, air embolism, and the release of cytokines. The endothelin-1 cytokine induces~     vasoconstriction of the pulmonary arterioles resulting in right ventricular afterload~     elevation. Treating patients with an endothelin-1 receptor antagonist might improve clinical~     outcome post operatively by decreasing right ventricular afterload~   "
142885|NCT01184391|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following~     a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.~   "
142886|NCT01184378|"~     The great majority of infants formula contain fats exclusively from vegetable oil.~     Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an~     infant formula closer to the nutritional composition of maternal milk.~   "
142887|NCT01184365|"~     Fatigue is a common complaint of persons with spinal cord injury (SCI) that negatively~     affects physical function, participation in daily activities, employment, and community~     involvement. No behavioural intervention for fatigue has been reported for SCI, though the~     benefits of such programs have been proven in persons with neurological conditions like~     multiple sclerosis and arthritis. Based on a study with people with SCI, an energy~     management program (EnMP-1) was developed. The focus of this study is to test EnMP-1. Adults~     with SCI living in the community and reporting fatigue as a problem will participate in the~     program.~      Hypothesis: Participants in the EnMP-1 group will show significantly lower fatigue impact~     scores and higher self-efficacy scores immediately after, 3 months, and 6 months~     post-intervention than EnMP-2 participants.~   "
142888|NCT01184352|"~     The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon~     Catheter for crossing during the treatment of coronary artery disease.~   "
142889|NCT01184339|"~     Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and~     methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's~     bacteriophage-based diagnostic platform, two gold-standard reference methods, and two~     predicate devices with similar indications for use.~   "
142890|NCT01184326|"~     This research study is evaluating the combination of pazopanib and everolimus in patients~     that have a malignancy that is metastatic or unresectable and for which standard curative or~     palliative measures do not exist or are no longer effective, or metastatic or locally~     advanced unresectable kidney cancer. In this research study the investigators are testing~     the safety of the combination of pazopanib and everolimus as well as to find the appropriate~     dose to use for further studies.~   "
142891|NCT01184313|"~     The purpose of this prospective, randomized clinical trial is to understand and measure lung~     injuries caused by CPB in aortic valve surgery.~      Study questions:~        -  Is there any correlation between the release of pro-inflammatory biomarkers and lung~          injury degree?~        -  Is there any correlation between oxyhaemodynamic parameters and lung injury degree?~        -  Is there any correlation between oxyhaemodynamic parameters and the release of~          pro-inflammatory biomarkers?~        -  Are budesonide, erdostein and acetylcystein effective in the prevention of lung~          injuries?~   "
142892|NCT01184300|"~     The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of~     a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using~     a CYP2C19*2 point-of-care genetic test.~   "
142896|NCT01184248|"~     The purpose of this study is to investigate if sound stimulation could improve pure-tone~     hearing threshold.~      In the late 1990s, researchers discovered that acoustic stimuli slow progressive~     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can~     delay the loss of auditory function. In addition, prolonged exposure to an augmented~     acoustic environment could improve age-related auditory changes. These ameliorative effects~     were shown in several types of mouse strains, as long as the acoustic environment was~     provided prior to the occurrence of severe hearing loss.~      In addition to delaying progressive hearing loss, acoustic stimuli could also protect~     hearing ability against damage by traumatic noise. In particular, a method called forward~     sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to~     reduce noise-induced hearing impairment in a number of mammalian species, including humans.~      Interestingly, recent report has suggested that low-level sound conditioning also reduces~     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and~     reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically,~     increased cochlear sensitivity was observed when distortion product otoacoustic emissions~     (DPOAEs) and compound action potentials (CAPs) were measured.~      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of~     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing~     ability against acoustic trauma and to prevent the cortical map reorganization induced by~     traumatic noise.~      Based on the results of animal studies, the investigators conducted a human study in 2007~     and observed that sound stimulation could improve hearing ability. On average, the pure-tone~     hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study,~     however, the investigators observed only the hearing threshold changes by sound stimulation.~      To verify the previous ameliorative effect of sound stimulation, the investigators included~     a control period in this study.~   "
142897|NCT01184235|"~     The study examines actigraphic, observational, psychometric and associated repeated~     measurements obtained prior to and during psychopharmacological treatment.~   "
142898|NCT01184222|"~     SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy~     of great occipital nerve stimulation (GONS) associated with medication withdrawal in the~     treatment of medication overuse headache occurring in migraine patients.~   "
142899|NCT01184209|"~     Prospective study to evaluate incidence, causes and potential risk factors for adrenal~     crisis in patients with chronic adrenal insufficiency.~   "
142900|NCT01184196|"~     This study will enroll patients who will be receiving primary total knee replacements.~     Subjects will be randomized into two groups: Betadine surgical scrub preparation and~     ChloraPrep preparation prior to total knee replacements.~      Study hypothesis: When used as a surgical scrub preparation prior to primary total knee~     arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is~     superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony~     counts.~   "
142901|NCT01184183|"~     Carotid Endarterectomy (CEA), surgical removal of the blockage in the neck artery, is the~     accepted management of choice for significant blockage of the carotid artery. Previous~     studies showed improved perioperative outcomes and prevention of recurrent blockage by the~     use of the patch to close the surgical incision in the artery. The ideal patch reduces~     bleeding and prevents recurrent blockage.This is looking at long-term results toward~     improvement with the use Accuseal patch than Bovine Patch.~   "
142902|NCT01184170|"~     The purpose of this study is to learn more about why some obese persons are resistant to~     developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease),~     while others are prone to developing these conditions. We will do this by studying obese~     persons before and after a 5% body weight gain.~      Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to~     increase their current body weight by 5%. Each will then be asked to maintain this weight~     increase for 3 weeks. We will monitor subjects throughout this time period with weekly~     medical evaluations. At the completion of the study, we will provide each subject with a~     6-month weight loss program.~   "
142903|NCT01184157|"~     This study randomizes women using long-acting reversible methods of contraception to~     home-based STD screening through the mail compared to screening available in a clinical~     setting. We hypothesize that women randomized to home-based screening will be more likely to~     complete screening.~   "
142904|NCT01184144|"~     The purpose of this study is to compare the effect of pioglitazone versus no drug on soluble~     profinflammatory markers in peritoneal fluid of women with endometriosis.~   "
142905|NCT01184131|"~     The research proposed in this collaborative application Implementation and Evaluation of~     Formal Training for Mentors of K-Series Mentored Career Development Awards will uniquely~     study mentor training in the biomedical academic community. The randomized controlled trial~     will be conducted at 15 Clinical and Translational Science Award sites over a 21-month~     period with six months for baseline data collection, nine months for the intervention, three~     months for follow-up, and three months for analysis. The multi-site trial will be conducted~     to determine whether the resultant skills-focused, case-based, mentor training program can~     improve the mentoring skills of K series mentors.~   "
142906|NCT01184118|"~     This study is being conducted to find out if the use of inhaled corticosteroids has an~     affect on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid~     is a common asthma controller medication like Flovent. Sleep apnea or sleep deprived~     breathing (SDB) is when someone stops breathing for a short period of time during sleep. For~     some reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility~     (weakness) than the general population. There are many possible reasons for this and one~     might be related to the use of inhaled corticosteroids.~      The overall hypothesis of this study is to determine whether inhaled fluticasone propionate~     (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as~     a potential underlying mechanism.~   "
142907|NCT01184105|"~     A phase I, single-center, double-blind, randomized, placebo-controlled, safety and~     pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and~     prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female~     healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the~     vagina and cervix for seven days~   "
142908|NCT01184092|"~     In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on~     three separate occasions using one of three different tablet formulations (tablet versions)~     each time. The amount of tasocitinib (CP-690,550) available in the blood following~     administration of each tablet formulation will be measured and compared. The overall aim of~     the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into~     the blood following administration of the same dose of each different tablet formulation.~   "
142922|NCT01183897|"~     The purpose of this study is to see find out what effects, good and/or bad, the combination~     of 3F8 and GM-CSF has on the patient and the cancer.~   "
142923|NCT01183884|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     3F8 and GM-CSF has on the patient and the cancer.~   "
142909|NCT01184079|"~     The investigators propose a randomized, open label trial of the immunogenicity of HPV~     vaccine among males 18-24 years old, comparing an on-time administration of the third dose~     with delayed administration of the third dose. All participants would receive the first and~     second doses according to schedule. They would be randomized to either Dose 3 at 6 months or~     Dose 3 at 12 months.~      Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the~     usual timing control group (C):~      H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified~     non-inferiority margin~   "
142910|NCT01184066|"~     The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in~     white American women, an alarming disparity that cannot be explained by stage of disease at~     presentation. Nonadherence to breast cancer treatment and treatment delays from diagnosis to~     initiation of treatment may be among the reasons for worse breast cancer outcomes in black~     women. This recognition is critical because it suggests that breast cancer survival~     disparity can be decreased through clinical interventions that increase adherence to~     chemotherapy. The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a~     onetime, intensive psycho-educational intervention using a race-matched breast cancer~     survivor interventionist to: address Attitudes, including perceptions and stressors, that~     may impact adherence to clinical visits and treatment; encourage and model patient~     Communication with health care providers regarding physical and emotional needs, with~     attention to race-discordant situations; and provide tailored, understandable information~     about Treatment and its rationale. The Support component is threaded throughout the~     intervention via the presence of a race-matched breast cancer survivor and supportive video~     messages from the black community. This study is a randomized controlled trial that will~     test the efficacy of the ACTS Intervention vs. Usual Care on the primary outcomes of~     adherence to recommended breast cancer chemotherapy.~   "
142911|NCT01184053|"~     The primary purpose of this study is to see whether women who have already received~     chemotherapy for their endometrial cancer, or who have disease that has spread outside of~     the uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of~     their tumor.~   "
142912|NCT01184040|"~     Contingency Management (CM) is highly effective in promoting recovery from substance use~     disorders, but benefits tend to attenuate over time when CM is discontinued. Identifying~     modifications of CM delivery that can extend its benefits is an important goal. The goal of~     this study is to evaluate the use of reinforcements to increase physical activity,~     specifically walking. The study provides a standard CM intervention to promote walking for~     three weeks. After three weeks, a progressively increasing variable interval schedule of~     reinforcement will be evaluated for increasing the durability of effects of the initial CM~     intervention. We hypothesize that Variable Interval Prize Contingency Management will result~     in greater adherence to a walking goal of 10,000 steps per day at Week 15 and Week 24~     compared to the Control Condition.~   "
142913|NCT01184027|"~     Weight loss resulting from poor food intake is common in head and neck cancer patients.~     Currently, feeding tubes are placed before starting treatment to provide nutrition and~     prevent weight loss. However, studies have not always shown that feeding tubes prevent~     weight loss. Also, limiting food intake by mouth may lead to swallowing problems. The aim of~     this study is to compare the effect of diet and swallowing therapy with feeding tube~     placement. In this study, your weight, food intake, swallowing ability, and side-effects of~     treatment will be monitored before, during, and 3 and 6 months after treatment to see if~     there is any difference between the therapy groups. The investigators hope that with the~     addition of diet and swallowing therapy during treatment that we can improve food intake and~     swallowing ability while still maintaining weight.~   "
142914|NCT01184014|"~     The objective of this study is to determine the best insulin regimen for hospitalized~     patients who receive high doses of steroids who have high blood glucose.~   "
142915|NCT01184001|"~     In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy~     subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550)~     tablet will be administered in a fasting condition; On the other occasion the tasocitinib~     (CP-690,550) tablet will be administered in a fed condition following a standard breakfast~     meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times~     over 24 hours following each dosing occasion and compared to evaluate for any differences.~   "
142916|NCT01183975|"~     Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample~     of centers representative of this activity in France.~      Verification by means of a screening log (exhaustive list of all bariatric procedures~     performed by participating surgeons between the beginning and end of the cohort inclusion~     period) requested from all centers.~      No comparator group. No randomization or blinding techniques~   "
142917|NCT01183962|"~     The purpose of this study is to evaluate the effect of Vitamin D supplementation on~     cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role~     in plaque formation in arteries. This study will determine the levels of Vitamin D and~     T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation~     will affect future events such as heart attach and stroke.~   "
142918|NCT01183949|"~     The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib~     are effective treatments in patients with previously treated multiple myeloma.~   "
142919|NCT01183936|"~     Objectives: The purpose of this study was to assess the effects of an excision margin of 2~     cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM).~      Study hypothesis: The hypothesis is that there is no difference between the two treatment~     arms measured as overall survival and recurrence free survival.~   "
142920|NCT01183923|"~     Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase~     II enzymes which play a critical role in preventing oxidative stress (via activation of~     Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.~      The main objectives of this study are to test the effect of broccoli sprouts (BS) on~     biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical~     outcomes in mouse allergen-induced asthma by (1) determining if BS improves lung function~     and airways symptom responses in mouse-sensitized adults with asthma undergoing~     environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS,~     inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS,~     inflammation, and basophil activation after EMAC.~   "
142925|NCT01183858|"~     This prospective, double-blind, randomized study will evaluate the safety and efficacy of~     two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease~     control rates and overall survival in patients with advanced or metastatic non-small cell~     lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must~     be current smokers and not intending to stop smoking during the study. Patients will be~     randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses.~     Treatment will continue until disease progression.~   "
142926|NCT01183845|"~     The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity~     of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and~     the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's~     Disease Endoscopic Index of Severity is the main score used in controlled trials to assess~     the endoscopic severity of lesions in Crohn's Disease.~      The investigators aim to conduct a prospective pilot study primarily to evaluate the~     applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the~     colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule~     endoscopy lead to comparable overall severity evaluations.~      Secondary objectives are to assess reproducibility of the reading of data obtained by CCE~     and to compare these data with those obtained by conventional ileocolonoscopy. If overall~     severity evaluations derived from the two examinations are not comparable, the secondary~     objectives will be used in an attempt to understand the reasons of this discrepancy.~   "
142927|NCT01183832|"~     This study is a description of the radiation effects on the healthy tissues in patients~     receiving Anastrozole, sequential or in association with radiotherapy.~   "
142928|NCT01183819|"~     The purpose of this study is to test the hypothesis that aerobic exercise and a~     computer-based cognitive intervention leads to improved cognitive function accompanied by~     increases in gray matter density and changes in functional magnetic resonance imaging (fMRI)~     patterns of task-related activation.~   "
142929|NCT01183806|"~     The purpose of this study is to determine whether a exercise program when combined with~     rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone~     would improve quality of life, ability to perform activities of daily living (ADL) and~     cognition in patients with Alzheimer's disease.~      Hypothesis:~      Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug~     treatment to improve quality of life of Alzheimer's disease patients.~      H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug~     treatment to improve quality of life of Alzheimer's disease patients, with an expectative of~     15% of improvement in the quality of life scale measurement~   "
142930|NCT01183793|"~     It is essential to know intestinal length and anastomotic type in post-operative short bowel~     syndrome patients. These parameters can help predict long-term intestinal failure with~     long-term parenteral nutrition usually needed for smallest lengths. Sometimes these~     parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is~     necessary to develop non-invasive and reproducible techniques to assess small bowel length.~     This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography~     and barium follow-through in this indication. There are at this time only two small studies~     evaluating barium follow-through for intestinal length measurement, and none evaluating~     MR-enterography. However, a major advantage of the latter is the lack of radiation exposure~     and possibility to perform 3D.~      This will be an open labelled single center crossover study. Short bowel syndrome patients~     of the investigators center will be included after consent. The sequence of exams (MR~     enterography followed by barium follow-through or vice-versa) will be randomly assigned.~     Peroperative short bowel length measurement will be available for all patients. There will~     be one month between the two exams.~      The main objective of this study is to assess the performance of MR-enterography in short~     bowel measurement in short bowel syndrome patients, the gold standard being peroperative~     length. Secondary objectives are to assess the performance of barium follow-through in short~     bowel measurement in these patients, and to show that barium follow-through does not perform~     better than MR-enterography. For that purpose the investigators will include 50 patients~     over 2 years.~   "
142931|NCT01183780|"~     The purpose of this study is to compare overall survival in participants with metastatic~     colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.~   "
142932|NCT01183767|"~     The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot~     study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major~     polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.~      In a second step the investigators want to investigate the effect of EGCG on the course of~     the Duchenne condition.~   "
142933|NCT01183754|"~     1. To evaluate the role of VerifyNow test as prognostic marker in routine clinical~          practice using drug-eluting stents.~        2. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors~          (clinical, lesions, or procedural factors).~        3. To compare the prognostic utility of VerifyNow test with several biomarkers.~   "
142934|NCT01183741|"~     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational~     device, to auscultation (measurement with a cuff) in determining systolic and diastolic~     blood pressure (BP) in adult subjects.~   "
142935|NCT01183728|"~     In this prospective study we aim to evaluate the feasibility and safety of the implantation~     of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The~     working hypothesis proposes that MSV antiinflammatory effect will help healing of articular~     cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging~     procedures. The study of quantitative changes in structure and composition of cartilage~     determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and~     disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and~     evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3,~     6,12 and 24 months.~   "
142936|NCT01183715|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.~   "
142937|NCT01183702|"~     The research will utilize LASIK and non-LASIK populations to analyze the biomechanical~     differences between these corneas.~   "
142938|NCT01183689|"~     The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test~     whether behavioral interventions based on self-regulation can prevent weight gain in young~     adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation~     interventions for weight gain prevention will be compared in this trial; one intervention~     will focus on making small, consistent, changes in eating and exercise behavior to prevent~     weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger~     changes in eating and exercise that occur periodically, with a goal of producing weight loss~     and thereby providing a buffer against anticipated weight gains. The primary aim of the~     trial is to test whether the magnitude of weight gain from baseline across an average~     three-year follow-up differs across the three groups, with the hypotheses that weight gain~     will be greater in the Control group than in either intervention and greater in the Small~     Changes than Large Changes group.~      SNAP-E (Extension) will determine whether the effects of the intervention can be maintained~     over an additional 3 years (i.e. through a total of 6 years).~   "
142939|NCT01183676|"~     The objective of this study was to investigate the bioequivalence of Mylan's divalproex~     sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following~     a single, oral 500 mg (1 x 500 mg) dose administration under fed conditions.~   "
142940|NCT01183663|"~     The goal of this clinical research study is to find the highest tolerable doses of the~     combinations of lenalidomide and other drugs that can be given to patients with advanced~     cancer. The safety of the drug combinations will also be studied.~   "
142941|NCT01183650|"~     The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese~     and non-Japanese men with Benign Prostatic Hyperplasia (BPH).~      The safety of tadalafil will also be studied.~   "
142942|NCT01183637|"~     The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to~     promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage~     meeting eligibility criteria will be randomly assigned to receive treatment with the~     Cartilage Repair Device or a standard surgical technique called microfracture. The purpose~     of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair~     Device compared to microfracture.~   "
142943|NCT01183624|"~     An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain~     of the right or left knee.~   "
142944|NCT01183611|"~     The primary safety objective of this study is to assess the safety of 10 mcg recombinant~     hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is~     to assess the antibody response following 3 doses immunization of the 10 mcg experimental~     dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates.~     This is a randomized, double-blinded, Phase III study. This study is designed to investigate~     the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine~     (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg,~     positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg~     and HBeAb and HBcAb.~        -  Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg~          and HBeAg will be randomized into two groups according to the ratio of 2:1. 120~          subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10~          mcg control vaccine respectively.~        -  Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but~          negative for HBeAg will be randomized into two groups according to the ratio of 2:1.~          240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive~          10 mcg control vaccine respectively.~        -  Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg~          and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will~          receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control~          vaccine. And the other 300 subjects will receive 5mcg control vaccine.~      The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each~     immunization, safety will be measured by assessment of adverse events through 30 days~     following each vaccination, serious adverse events and new-onset chronic medical conditions~     through 6 months post the final vaccination (Day 180 after last vaccination). For the~     immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the~     day 0, 210 and 360 after born.~   "
142945|NCT01183598|"~     This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a~     maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit~     from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or~     significant adverse events. Patients will receive their most effective maintenance dose~     until disease progression or significant toxicity occurs.~   "
142946|NCT01183585|"~     This single centre, open-label study will investigate the effect of RO4917838 on the~     pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers.~     Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of~     Rosuvastatin.~   "
142947|NCT01183572|"~     The purpose of this study is to determine whether daily oral supplements of multivitamins~     (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant~     women results in lower prevalence of anemia in preparation for pregnancy when compared to~     daily iron and folic acid supplements or folic acid alone.~   "
142948|NCT01183559|"~     The purpose of the study is to determine the most tolerable and safe dose of ZD6474~     (Zactima) when given with standard chemotherapy, radiation therapy and surgery in patients~     with cancer of the esophagus~   "
142949|NCT01183546|"~     The purpose of this research study is to further develop and refine the Transfer Assessment~     Instrument (TAI). The TAI is a clinical tool to be used by therapists to evaluate transfer~     techniques and performance.~   "
142950|NCT01183533|"~     The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV~     t-PA) in ischemic stroke patients who present to the emergency department (ED) after~     awakening with the symptoms of suspected ischemic stroke.~   "
142951|NCT01183520|"~     The overall goal of this project is to identify an appropriate level of high omega-3 fish~     (salmon) consumption that will promote optimal omega 3 nutritional status without increasing~     the level of lipid oxidation in the body.~   "
142952|NCT01183507|"~     The purpose of this research study is to evaluate the effect of two different exercise~     programs on physical function in men and women 60 years of age and older.~   "
142953|NCT01183494|"~     This study is being done to determine the maximum dose of a certain chemotherapy drug~     (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination~     of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil~     (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present~     time, the Food and Drug Administration (FDA) has approved this drug combination for the~     treatment of cancers of the colon and rectum. The FDA has also approved the use of a drug~     called bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of~     the standards of care for all patients with colon and rectal cancer which has spread.~      The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not~     known. Earlier studies have shown that higher doses of irinotecan can be used safely as part~     of the FOLFIRI combination, but it is unclear whether these same doses will be safe when~     bevacizumab is added to this combination.~   "
142954|NCT01183481|"~     The primary objective of this pilot study is to examine the efficacy of Aprepitant given in~     combination with Granisetron for the prevention of delayed-phase RINV in 84 patients~     receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook~     Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will~     be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least~     one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings~     on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining~     the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control~     rate, the safety of the combined regime, QOL issues, the time to the first emetic event and~     the time to the first use of rescue medication .~   "
142955|NCT01183468|"~     The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an~     anti-inflammatory drug (a medication that decreases inflammation, which is part of the~     body's normal ability to fight infection and respond to injuries) that affects the cells~     thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D).~      All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days~     of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria).~     The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics~     (PD) and safety. Upon completion of Part I, including a satisfactory safety review,~     enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.~   "
142956|NCT01183455|"~     Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug~     to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects~     the cells that are thought to be involved in the development of type 1 diabetes mellitus~     (T1DM, T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the~     effect of Aralast NP on preserving beta cell function and to determine if the intervention~     would slow the progression of type 1 diabetes.~      Part I of this trial (NCT 01183468) was an open-label, safety and dose level study~     consisting of two groups. After completion of Part I, including a satisfactory safety~     review, enrollment in Part II was to begin. Part II was designed as a two-arm, double-blind,~     placebo-controlled clinical trial, and participants were to be randomly assigned to either~     the Aralast NP treatment or placebo group.~   "
142957|NCT01183442|"~     The main aim of the investigation is to clarify, whether vitamin D supplementation in~     coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia~     has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell~     function.~   "
142958|NCT01183429|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     3F8 and GM-CSF has on the patient and the cancer.~      Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of~     one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has~     been used safely in many patients, and it has killed cancer cells in some patients. One way~     it can kill cancer cells is by causing the patient's own white blood cells to attack the~     cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of~     granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.~   "
142959|NCT01183416|"~     The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than~     standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out~     what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the~     antibody works against a very small amount of neuroblastoma (minimal residual disease) that~     is left in the bone marrow.~   "
142960|NCT01183403|"~     The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has~     not been clearly demonstrated. The results reported by some teams suggest no beneficial~     effect or even an increased risk of bowel obstruction in the case of stricture, while other~     publications indicate a favourable action of anti-TNF in this setting. The efficacy of~     anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on~     the lesions responsible for the stricture, as anti-TNF agents are probably effective in~     inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice,~     the decision is currently empirical and a trial of anti-TNF therapy is often proposed.~      In view of the high incidence of intestinal strictures in CD and the need for a treatment as~     effective as anti-TNF in this setting, it is important to more clearly define the~     indications of these treatments guided by the information provided by modern imaging.~      The aim of this prospective study is to determine whether certain signs detected by MR~     enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF~     therapy in patients with CD presenting a symptomatic stricture of the small bowel and~     scheduled to receive this treatment.~   "
142961|NCT01183390|"~     The objective of this study is to evaluate the comparative bioavailability between~     Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca~     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.~   "
142962|NCT01183377|"~     Women's evermore presence in professional and athletic sports has revealed sound evidence on~     the existence of female athlete triad among the world's elite female athletes. This triad~     consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all~     female athletes are potentially at risk, but it is not clear to what extent those exercising~     at different levels are at risk of this syndrome/triad. Since the manifestation of this~     triad is often denied, or under-reported, appropriate screening methods are required to~     identify the symptoms. There is still no clear-cut information available on the incidence of~     this triad in Iran. And there are religious and cultural differences between Iran's elite~     female athletes and those in other countries. Therefore, in order to meet Iranian female~     athletes' needs, the investigators decided to determine the frequency of the female athlete~     triad in Iran.~   "
142963|NCT01183364|"~     This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of~     STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor~     malignancies. The safety and tolerability of the treatment will also be evaluated.~   "
143091|NCT01181674|"~     The purpose of this pilot trial is to determine whether an intensive treatment with insulin~     glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients~     with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.~   "
142964|NCT01183351|"~     The increasing prevalence of dementia is a major challenge to the health authorities in most~     countries. Nearly all the persons suffering from dementia experience behavioural and~     psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes.~     BPSD are often treated with psychotropic drugs even though the evidence for effect is~     minimal and the risk of serious adverse events is considerable. All the major treatment~     recommendations advise that non-pharmacological measures should be applied first when~     treating BPSD even though the evidence for such treatment is limited. The investigators will~     conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been~     developed in Norway and has already been implemented in a number of nursing homes in the~     county of Nordland.~   "
142965|NCT01183338|"~     The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational~     device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human~     subjects.~   "
142966|NCT01183325|"~     For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or~     the use of mesh continues.~      About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh~     with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of~     using this patch, recent experience showed several drawbacks both in design and efficacy~     (3).~      With the recent development of the Proceed Ventral Patch (PVP), new elements have been~     introduced to overcome some of these issues.~      The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the~     intra-abdominal position in the treatment of small ventral hernias.~   "
142967|NCT01183312|"~     The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness~     and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is~     caused by a problem with the quality of sleep occurring at night, for instance when~     nighttime sleep is disrupted by frequent breathing pauses. In other cases, however,~     hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia~     are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of~     central (i.e., brain) origin, or primary hypersomnias.~      The causes of most of these primary hypersomnias are not known. However, our group has~     recently identified a problem with the major brain chemical responsible for sedation, known~     as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance~     that causes the GABA receptor to be hyperactive. In essence, it is as though these patients~     are chronically medicated with Valium (or Xanax or alcohol, all substances that act through~     the GABA system), even though they do not take these medications.~      Current treatment of central hypersomnias is limited. For the fraction of cases with~     narcolepsy, there are FDA-approved, available treatments. However, for the remainder of~     patients, there are no treatments approved by the FDA. They are usually treated with~     medications approved for narcolepsy, but sleep experts agree that these medications are~     often not effective for this group of patients.~      Based on our understanding of the GABA abnormality in these patients, we evaluated whether~     flumazenil (an medication approved by the FDA for the treatment of overdose of GABA~     medications or the reversal of GABA-based anesthesia) would reverse the GABA abnormality in~     our patients. In a test tube model of this disease, flumazenil does in fact return the~     function of the GABA system to normal. The investigators have treated a few patients with~     flumazenil and most have felt that their hypersomnia symptoms improved with this treatment.~      To determine whether flumazenil is truly beneficial for primary hypersomnia, this study will~     compare flumazenil to an inactive pill (the placebo). All subjects will receive both~     flumazenil and the placebo at different times, and their reaction times and symptoms will be~     compared on these two treatments to determine if one is superior. Currently, flumazenil can~     only be given through an injection into a vein (i.e., intravenously). This study will~     evaluate this intravenous dosing as well as a new form of flumazenil, which is taken as a~     lozenge to be dissolved under the tongue. If this study shows that flumazenil is more~     effective than placebo in the treatment of hypersomnia, it will identify a potential new~     therapy for this difficult-to-treat disorder.~   "
142968|NCT01183299|"~     The Salty Life 7 study aimed to examine the effect of a high salt (sodium chloride, NaCl)~     intake on different forms of sodium retention, acid-base balance and bone metabolism and~     other influenced physiological systems. Because of the fact that astronauts are a vulnerable~     group in this context, they were of special interest. Astronauts have a high salt intake,~     probably because of a reduced sense of taste, as well as an increased bone resorption~     resulting from the lowered mechanical load in space. In which forms sodium could be retained~     even without fluid retention (osmotically inactive)- contrary to the argumentation of~     physiological text books - and if the acid-base balance is connected to sodium chloride~     induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male~     test subjects. The study consisting of 2 x 21 days is carried out at the German Aerospace~     Center (DLR). After an adaptation period of 4 days, test subjects are immobilised in 6°~     head-down tilt bed rest (simulation model for some physiological changes in space) for 14~     days during which they received a high (7.7 mmol NaCl/kgBW/d) and a low salt (0.7 mmol~     NaCl/kgBW/d) intake in cross-over design. The form of sodium retention is investigated by~     the calculation of daily metabolic sodium-, water- and potassium balances and by changes in~     body weight. The measurements of bone formation (bAP, PINP, Osteocalcin) markers as well as~     bone resorption markers (CTX, NTX) supply insight into the influences of a high salt intake~     on bone metabolism. Blood gas analysis and ph values of 24-h urine are used to gather~     information about accompanying changes in the acid-base balance. Further physiological~     systems like energy metabolism and circulation system are also under investigation.~   "
142969|NCT01183286|"~     Adolescents with cystic fibrosis are particularly vulnerable to poor adherence, which~     negatively impacts their health status, quality of life and long term survival. CFFONE: A~     Cell Phone Support Program for Adolescents with Cystic Fibrosis, will make use of~     cutting-edge technology- a broadband capable, cellular telephone keyed into a~     highly-interactive informational web site. This web site will provide engaging online~     learning activities and resources specific to adolescents with cystic fibrosis. We believe~     the information and activities contained in CFFONE will improve adolescents knowledge,~     attitudes, and practices around cystic fibrosis and that adolescents exposed to the CFFONE~     program will demonstrate an increase in adherence to their treatment regimens and related~     improvements in their health status and quality of life.~   "
142982|NCT01183104|"~     The purpose of this study is to compare the efficacy and the safety of sitagliptin and~     glimepiride in drug naïve elderly patients with T2DM as evaluated by HbA1c change from~     baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as~     safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in~     efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to~     glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients~     with T2DM. In addition, comparison of efficacy is extended to 104W.~   "
142983|NCT01183091|"~     The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia~     increases with the age, and the investigators consider that beyond 65 years, 5 % of the~     population is affected by this arrhythmia. It entails a greater risk of morbidity~     (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality~     (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the~     associated risk factors. For all these reasons, it raises a real problem of public health.~   "
142970|NCT01183273|"~     Background Laparoscopy is the preferred surgical approach for a number of different diseases~     as it allows for diagnosis and treatment in the setting of a safe and feasible method~     offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which~     utilizes smaller instruments and optics. Technological advancements have enabled~     miniaturization of the surgical equipment without compromising diagnostic or operative~     capabilities.~      Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an~     identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura~     Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and~     their size to decrease trauma to the abdominal wall.~      Study Design Both methods have never been compared in a prospective randomized trial to~     address the following questions.~        1. Is there a difference in outcome?~        2. Is there a decrease in postoperative pain?~        3. Does it decrease time off from work?~        4. Does micro-laparoscopy increase OR time?~        5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or~          the other method, disclosing that to the investigators best knowledge both methods are~          equally safe and that Dr. Zuccala has performed several hundred cases using both~          methods.~      Patient Population Projected sample size would be 50 patients in each group. Accrual should~     be feasible over the course of 9-12 months.~      Data collection (patients will be followed for a total of 30 days for the purpose of this~     study)~        1. NSQIP data to assess outcome~        2. Postoperative usage of pain medication while in the hospital~        3. Time off from work~        4. OR time~        5. Direct cost of procedure as it relates to material used~   "
142971|NCT01183260|"~     In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology,~     Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was~     developed to address the limitations of other implant materials, with the potential to~     improve implant fixation.~      Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft~     incorporation, believed to be restricted by the low porosity of other commonly used implants~     (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum~     provides more normal physiological loading conditions which theoretically reduce stress~     shielding and resultant bone loss surrounding the implant. These properties are much desired~     advantages for implants used in cementless THA.~      Various porous tantalum implants have shown favorable clinical results. Unger et al.~     reported excellent bone graft incorporation of the acetabular component based on serial~     radiograph data at a minimum 1-year follow-up.~      Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting~     periprosthetic bone mass changes around the femoral and acetabular THA components.~      The primary objective of this study is to quantify and compare periprosthetic bone mineral~     density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed~     acetabular components, measured using DEXA scanning techniques. Additionally, this study~     will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.~   "
142972|NCT01183247|"~     An open, single center, randomised study to investigate three different immunosuppressive~     regimens for de novo renal transplant recipients:~        1. st sirolimus / EC-MPS / tacrolimus regimen~           - After 3 months a protocol biopsy is performed. If no rejection is detected the~          calcineurin inhibitor (tacrolimus) is withdrawn.~        2. nd everolimus / EC-MPS / tacrolimus regimen~           - After 3 months a protocol biopsy is performed. If no rejection is detected the~          calcineurin inhibitor (tacrolimus) is withdrawn.~        3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is~          performed. If no rejection is detected prednisone is withdrawn.~   "
142973|NCT01183234|"~     The purpose of this study is to assess bioequivalence of 2 capsule strengths.~   "
142974|NCT01183221|"~     This study examines the effects of oxytocin on complex social cognition in adults with~     autism spectrum disorders. Participants receive a one-time administration of intranasal~     oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid~     measure of complex social cognition, in conjunction with functional magnetic resonance~     imaging (fMRI). We will investigate the effects of oxytocin (versus placebo) on the~     behavioral and neural correlates of empathic accuracy.~   "
142975|NCT01183208|"~     A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group,~     Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to~     Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and~     O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects~     Following Daily Application to the Vagina and Cervix for Seven Days With Three Different~     Doses of PSD502 or Placebo~   "
142976|NCT01183182|"~     This study is designed to provide clinical data regarding safety and clinical effectiveness~     of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous~     needle biopsy or aspiration of pulmonary lesions, which is a common procedure.~   "
142977|NCT01183169|"~     The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who~     have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV)~     may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV~     versus placebo with PEG and RBV.~   "
142978|NCT01183156|"~     The aim of this study is to compare the effect of reminding letter and educational~     intervention on attendance to screening colonoscopy in nonresponders to initial invitation~     to screening colonoscopy.~   "
142979|NCT01183143|"~     This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the~     convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating~     hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also~     in in-vitro fertilisation (IVF).~   "
142980|NCT01183130|"~     The aim of the study is to examine whether electronic compliance monitoring in real time~     could offer some advantages compared to normal electronic monitoring in opioid substitution~     treatment. The investigators would also like know whether this method could enable the quick~     detection of possible problems in medication intakes and/or prevent the abuse or diversion~     of substitution medications.~   "
142981|NCT01183117|"~     The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis~     S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA~     (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed~     separately.~   "
142984|NCT01183078|"~     Hypothesis: Utilization of the wand method will enhance improvements in drill placement,~     locking nail placement during tibia and femur fracture repairs, and offer less radiation~     exposure and less operative time. The purpose of this research study is to compare the~     efficacy of distal locking of intramedullary nails using a standard free-hand technique with~     the guided wand technique. Distal locking is the placement of screws through the~     intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand~     technique is most often utilized. With this technique, the surgeon uses intraoperative~     x-rays in order to find the holes in the intramedullary rod to place the screws. The wand~     technique uses electromagnetic fields rather than x-rays to find these screw holes. The~     utilization of the wand technique could result in improvements in drill placement and~     locking nail placement as well as decrease operative time and radiation exposure.~   "
142985|NCT01183065|"~     The purpose of this study is to find out if the experimental drug pralatrexate with the~     vitamins folic acid and vitamin B12 might be an effective treatment for head and neck~     cancer. The reason we are doing this study is because another drug called methotrexate has~     been used for a long time to treat head and neck cancer patients. Pralatrexate was designed~     by scientists to be a new drug that works better than methotrexate. Laboratory studies have~     shown that pralatrexate works better than methotrexate at killing cancer cells.~      Pralatrexate has already been studied in patients with other types of cancers, such as~     lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was~     recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer~     called peripheral T cell lymphoma.~   "
142986|NCT01183052|"~     The purpose of this study is to understand the underlying mechanisms of improved exercise~     tolerance in COPD patients after training program.~   "
142987|NCT01183039|"~     The purpose of this study is to understand underlying mechanisms of improved exercise~     tolerance in Healthy Sedentary Subjects after training program.~   "
142988|NCT01183026|"~     The objective of the study was to assess diagnostic performance of V/Q SPECT for the~     diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic~     strategy.~   "
142989|NCT01183013|"~     The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after~     30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective~     individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once~     daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of~     treatment effect and safety under chronic treatment conditions will be investigated.~   "
142990|NCT01183000|"~     Objective: To determine the effect of non-closure of the visceral and parietal peritoneum~     during Cesarean section on the formation of adhesions.~      Study design: A prospective randomized trial of 533 women undergoing primary Cesarean~     section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a~     subsequent cesarean,he presence of adhesions and their severity was evaluated at several~     sites: between the layers of the abdominal wall, between the bladder and the abdominal wall,~     between bladder and uterus, between the uterus and the abdominal wall, and between the~     bowels and the pelvic organs. A cumulative adhesion score was calculated.~   "
142991|NCT01182987|"~     The SCAN Memory Program Evaluation study is an evaluation of a randomized controlled trial~     intervention consisting of a care management program for cognitively-impaired health plan~     members and for their informal/family caregivers. The program includes collaboration between~     the health plan, partnering medical groups, and community organizations.~      Program activities include: 1) telephonic-structured assessments with informal caregivers~     conducted by SCAN Memory Program care managers; 2) problem identification as a result of~     these assessments; and 3) pre-established protocols and procedures for problem resolution.~     ACCESS, the prototype for the SCAN Memory Program, was developed and tested in San Diego~     County and was very successful in helping affected patients and their caregivers.~   "
142992|NCT01182974|"~     The investigators will examine the toxicity of therapeutic doses of paracetamol in patients~     in severe sepsis. Patients with fever and severe sepsis will be randomized to receive~     paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes~     to look for potential toxicity.~   "
142993|NCT01182961|"~     The study aims to investigate the efficacy of gait training using virtual reality to~     decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that~     training with virtual reality would increase the ability to perform in the real world~     environment and decrease the risk of falls in elderly adults.~   "
142994|NCT01182948|"~     The purposes of this study are: a) to compare the effects of supervised programs of aerobic~     training or resistance training on the metabolic control of type 2 diabetes; b) to~     investigate some potential pathophysiologic and molecular mechanisms underlying these~     effects; c) to assess whether some changes may persist over time after termination of the~     supervised programs.~   "
142995|NCT01182935|"~     Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were~     re-examined with an oral glucose tolerance test to see predictive value of triglycerides~     regarding development of type 2 diabetes~   "
142996|NCT01182922|"~     The purpose of the study is to investigate whether the information about a doctor or~     possibility to choose doctor's gender included in invitation letter is associated with~     attendance rate to screening colonoscopy.~   "
143004|NCT01182805|"~     The purpose of this study is to evaluate a novel ultrasound system's ability to assess the~     relaxing properties of the heart compared to current techniques.~   "
143018|NCT01182623|"~     It is current practice to remove any polyps found during colonoscopy. This is because~     adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps~     <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires~     these to be removed, as it is traditionally felt that they cannot be separated clinically~     from adenomas. This increases the risk of perforation and results in a significant cost in~     processing the samples. However, it has been suggested that it is possible to differentiate~     neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If~     this is the case the investigators may be able to reduce the need for polypectomy The~     investigators believe that it is possible to tell the difference between polyps with~     cancerous potential and those that are harmless by assessment of surface patterns. This may~     enable us to improve the investigators clinical decisions when assessing polyps during~     colonoscopy, and reduce the number of unnecessary polypectomys being performed.~   "
142997|NCT01182909|"~     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China~     and Southeast Asia. While infection with Epstein-Barr Virus (EBV) is believed to be~     necessary for the development of NPC, non-viral environmental factors have also been~     implicated to increase the risk of NPC including consumption of salted fish and other~     nitrosamine containing preserved foods, formaldehyde and wood dust exposure, and cigarette~     smoking. In addition to environmental factors, it is widely accepted that genetic~     susceptibility also plays an important role in the pathogenesis of NPC. Polymorphisms in~     genes involved in nitrosamine metabolism and DNA repair have been suggested to be associated~     with NPC risk, and various chromosomal regions linked to NPC development have been reported.~     These associations highlight the role of both environmental and genomic components in the~     etiology of NPC.~      There is a longstanding history of international collaborative studies to elucidate the role~     of environmental and genetic factors associated with NPC between investigators in Taiwan and~     the USA. A case-control study (375 cases; 327 controls) was conducted in the early 1990s,~     and a large multiplex family study that was completed in 2006 (358 families; 3,216~     individuals). Results from these studies have provided some of the most comprehensive~     epidemiological evidence regarding factors linked to NPC development to date.~      As a next logical step, the opportunity now exists to undertake a genome-wide association~     study of NPC in Taiwan with carefully collected environmental exposure data to~     systematically examine environmental and genetic factors associated with NPC, and to~     evaluate gene-gene and gene-environment interactions. The investigators propose a~     case-control study of 2000 NPC cases (both retrospective [n=800] and prospective [n=1,200])~     and 2,000 age-gender-matched hospital controls in northern Taiwan. The study objectives are~     to: 1) evaluate putative environmental exposures and NPC; 2) assess the effect of genetic~     factors, including both single nucleotide polymorphism and copy number variation through~     analysis of both main effect and gene-gene interaction; 3) investigate gene-environment~     interactions by testing for interactions between significant genome-wide genetic variations~     and EBV and other identified environmental risk factors; and 4) examine the natural history~     of EBV infection.~   "
142998|NCT01182883|"~     Background:~      - IMC-A12 is an experimental substance designed to inhibit a protein called Type I~     Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can~     promote cancer growth. Temsirolimus is a drug that the U.S. Food and Drug Administration has~     approved to treat advanced renal cell carcinoma in adults. Researchers do not know if the~     combination of IMC-A12 and temsirolimus will work in children, but want to determine whether~     these two drugs may be an effective treatment for recurrent tumors.~      Objectives:~        -  To determine the safety and effectiveness of IMC-A12 and temsirolimus in treating~          children and adolescents with solid tumors.~        -  To determine possible side effects of the combination of IMC-A12 and temsirolimus.~      Eligibility:~      - Children and adolescents between 12 months and 21 years of age who have solid tumors that~     have not responded to or have relapsed after standard treatment.~      Design:~        -  Participants will be screened with a medical history, physical examination, and imaging~          studies.~        -  Participants will receive IMC-A12 and temsirolimus in 28-day cycles of treatment.~          IMC-A12 will be given as an infusion over 1 hour, once a week, for 4 weeks.~          Temsirolimus will also be given after IMC-A12 over 30 minutes, once a week, for 4~          weeks.~        -  Participants may continue to receive IMC-A12 and temsirolimus for up to 2 years unless~          serious side effects develop or the treatment stops being effective.~        -  Participants will have additional physical exams, blood and urine tests, and imaging~          studies regularly during each treatment cycle.~        -  Participants will be followed at regular intervals after the end of the study to~          collect tumor response and progression data....~   "
142999|NCT01182870|"~     Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if~     they were ill with influenza during the winter season 2009/2010 to see if vitamin d~     supplementation prevented flu like disease.~   "
143000|NCT01182857|"~     Background:~        -  Severe combined immunodeficiency (SCID) is a rare inherited disorder in which certain~          white blood cells have impaired function and are unable to properly fight infections.~          SCID typically appears within the first year of life and is characterized by multiple,~          recurrent severe infections. More than 10 percent of all cases of SCID involve a~          deficiency of an enzyme called adenosine deaminase (ADA), and these SCID patients also~          tend to have impaired brain function or psychiatric disorders. Researchers are~          attempting to treat ADA-SCID patients with an experimental gene therapy, and a research~          protocol has been established for those who are participating in this therapy.~        -  Little is known about quality of life in individuals with ADA-SCID, but researchers~          believe that the effects of the disease and the treatments may cause a decreased~          quality of life in both patients and their parents. Another potential cause of~          decreased quality of life in ADA-SCID is the associated psychiatric and neurological~          problems caused by the disease. Researchers are interested in studying quality of life~          in individuals with ADA-SCID and their parents to provide more information about the~          disease.~      Objectives:~        -  To evaluate whether gene therapy alters the quality of life or neuropsychiatric status~          of children with ADA-SCID.~        -  To monitor for intellectual, attention, memory, or specific learning disorders in~          children with ADA-SCID.~        -  To evaluate whether undergoing gene therapy has an effect on parenting stress of~          parents whose children have ADA-SCID.~      Eligibility:~        -  Children who are participating in the ADA-SCID gene therapy research protocol~          (01-HG-0189).~        -  Parents of children who are participating in the ADA-SCID gene therapy research~          protocol (01-HG-0189).~      Design:~        -  All of the testing and questionnaires will be done in the pediatric or adult clinic.~        -  Participating children will have tests of intelligence, manual dexterity, reaction~          time, basic reading and arithmetic skills, speech, and memory. These tests will be~          given before the start of the therapy, and then once a year for 5 years.~        -  Participating children will also complete questionnaires on quality of life. These~          questionnaires will be given before the start of the therapy, 3 months and 6 months~          after the therapy, and then every 6 months for a total of 5 years.~        -  Additional psychological tests may be given at the discretion of the study researchers.~        -  Parents will complete questionnaires to provide background medical information and~          report on quality of life and parental stress. The background information~          questionnaires will be given at the start of the therapy and then once a year for 5~          years, the parental stress questionnaires will be given at the start of the therapy and~          then every 6 months for 5 years, and the quality of life questionnaires will be given~          at the same time as the child quality of life questionnaires.~        -  This protocol is separate from the gene therapy treatment protocol.~   "
143001|NCT01182844|"~     Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an~     important role in the development of inflammation and metabolic syndrome in obesity.~     Modulation of gut flora by probiotics has been shown in animal studies to positively~     influence inflammation and metabolic disturbances.~      Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora~     composition and gut permeability which leads to an improvement in neutrophil function and~     insulin resistance in obesity.~      The aim of the current study is to investigate the effect of Lactobacillus casei Shirota~     supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR~     expression) in patients with metabolic syndrome.~      Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota~     supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut~     flora composition, gut permeability, and endotoxemia in metabolic syndrome~   "
143002|NCT01182831|"~     Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma~     pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic~     guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better~     visualization of the plexus. There are limited data comparing the two modalities.The~     patients are on follow-up for 6 months post neurolysis.~   "
143003|NCT01182818|"~     More than one million people in Europe suffer from a stroke every day. Normally older people~     have a stroke, but also a significant number of younger people between 18 and 55 years.~     Usually, these can only be explained for a minority by the classical risk factors such as~     diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of~     the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry~     disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The~     purpose of this study is to determine in a large number of young stroke patients, how many~     strokes were caused by Fabry disease and what risk factors might be able to predict this~     disease.~   "
143005|NCT01182792|"~     Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD)~     or emphysema, represent major medical and socio-economical problems and one of the leading~     cause of morbidity and mortality in the western countries. Recently, is has been shown that~     cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these~     patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a~     central role in the mediation of the increased CV risk in patients with COPD. However the~     underlying mechanisms of vascular dysfunction in these patients are incompletely understood.~     Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in~     part to hypoventilation; it affects relatively young adults, and may therefore allow to~     study the effects of chronic hypoxemia. The investigators therefore will assess systemic~     vascular function and test the hypothesis that increased oxidative stress is responsible for~     this dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been~     suggested to affect vascular function, the investigators will test the effects of~     hemodilution on vascular function. Then, the investigators will test the effects of acute~     oxygen application and 1 month antioxidative dietary supplement on vascular function.~      Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic~     vascular dysfunction. Antioxidant administration is know to improve vascular function. We~     will test the acute effect of Vitamin C in this setting.~      Finally, since there is considerable inter-individual variability of pulmonary artery~     pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in~     clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the~     prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on~     pulmonary artery pressure at rest and during mild exercise.~   "
143006|NCT01182779|"~     This study is a prospective randomised clinical phase III trial. The primary objective of~     this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas~     is superior to the standard proton treatment with respect to the local-progression free~     survival (LPFS).~   "
143007|NCT01182766|"~     This research study aims to test whether topiramate (a drug that is being used for seizure)~     will help individuals who have problems with both alcohol and nicotine. The investigators~     believe that individuals taking topiramate will be more successful at abstaining from both~     alcohol and nicotine than individuals taking placebo.~   "
143008|NCT01182753|"~     The study is a prospective randomised clinical phase III trial. Proton therapy is the gold~     standard in the treatment of low and intermediate grad chondrosarcomas of the skull base.~     However, high-LET beams such as carbon ions theoretically offer biologic advantages by~     enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to~     compare two different particle therapies, i.e. proton and carbon ion therapy directly with~     each other. The aim of this study is to find out, whether the biological advantages of~     carbon ion therapy mentioned above can also be clinically confirmed.~   "
143009|NCT01182740|"~     The investigators will compare the success rates of endotracheal intubation in a simulated~     entrapped car accident victim (manikin) using different video laryngoscopes by experienced~     emergency physicians.~      The investigators hypothesized that video laryngoscopes may improve success rates.~   "
143010|NCT01182727|"~     Being obese is a common problem for people with schizophrenia. People with schizophrenia are~     more likely to be overweight compared to the general population. Being overweight is a major~     risk factor for developing type II diabetes. Approximately 15% of people with schizophrenia~     have type II diabetes. People with type II diabetes have problems with their body's insulin.~     Insulin is a hormone produced by the body to control blood sugar level. Obesity and type II~     diabetes are strong risk factors for heart disease. In type II diabetes the body does not~     respond to insulin correctly. Obesity, type II diabetes, and insulin resistance are all~     common states of inflammation. Inflammation is a reaction by the body to irritation, injury,~     or infection.~      Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a~     salicylate. These drugs work by decreasing the level of inflammation in the body.~     Salicylates have been shown to decrease inflammation and improve the body's response to~     insulin. Improving the body's response to insulin and decreasing inflammation could possibly~     reduce the risk of developing type II diabetes. Salicylates have been known for years to be~     effective for the treatment of diabetes. Salicylates increase the body's response to insulin~     causing blood sugar levels to decrease. Many salicylate drugs have side effects including~     stomach irritation and increased risk of bleeding. The drug for this study is called~     salsalate and is different from other salicylates. Salsalate has a lower bleeding risk than~     aspirin. Salsalate has been used to treat arthritis and has been shown to be safe.~      There have been no studies using salsalate in people with schizophrenia. The purpose of this~     study is to gain experience in the use of salsalate in people with schizophrenia. The study~     would be a pilot study to obtain preliminary data. The study would be a 6-week study where~     everyone in the study would receive the drug salsalate. The participants in the study will~     have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart~     function), and a side effect checklist for possible side effects from salsalate. The study~     will also have some blood drawn to measure blood sugar levels, insulin levels, and~     inflammatory markers.~   "
143011|NCT01182714|"~     Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In~     Hong Kong, it was the most common gynaecological open procedure done and the number of~     hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling~     catheter use after uncomplicated abdominal hysterectomy has been the standard method for~     bladder treatment after the operation. It is traditionally advocated to assess urinary~     output and to prevent post-operative urinary retention as patients with abdominal wound are~     unable to increase the intra-abdominal pressure to aid voiding. However, in-dwelling~     catheters have been associated with increased white cell counts and higher rates of positive~     urine cultures, and subsequently urinary tract infection can lead to increased morbidity,~     duration of hospital stay, and overall healthcare cost.~      Duration of catheter use post-operatively is generally based on custom rather than~     evidence-based knowledge and therefore varies considerably. The current practice of the~     investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an~     uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour~     catheterization after common gynaecological procedures was associated with a low rate of~     voiding problems after catheter removal. Post-operative urinary retention leading to bladder~     atony may increase the long-term morbidity through increased risk of infection, detrusor~     instability and voiding difficulties. In-dwelling catheter in the immediate post-operative~     period will help to combat this problem. However, this has to be balanced against the~     potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in~     the published trials.~      A prospective randomized study comparing immediate versus delayed catheter removal following~     hysterectomy showed that delayed removal after operation was not associated with an~     increased rate of febrile events or urinary tract infections, but a significantly higher~     subjective pain assessment. The size of the catheter used was 16F which was not the standard~     12F that the investigators used in the investigators hospital setting. It is postulated that~     if a smaller caliber in-dwelling catheter is used, it will not result in an increased~     subjective pain assessment, and the catheter can be left in-situ for 24 hours without~     causing increased adverse outcomes but possibly reducing recatheterisation rate~     post-operatively.~   "
143012|NCT01182701|"~     The proposed study is a two arm randomized controlled trial with longitudinal follow-up that~     compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The~     experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs.~     Control) by Time (Pre, Post, Follow Up).~   "
143013|NCT01182688|"~     This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the~     rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above~     and beyond the changes seen with the acute and inflammatory response induced by~     cardio-pulmonary bypass.~      Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe~     bacterial infections and sepsis. PCT supports early diagnosis and clinical decision~     making.This is a prospective single center study designed to assess the normal change in PCT~     levels following major surgery and the utilization of PCT regarding the diagnosis of~     infection and the response to treatment, following major cardiac surgery~   "
143014|NCT01182675|"~     The goal of this study is to develop a novel approach to hematopoietic stem cell~     transplantation for children with Severe Combined Immunodeficiency Disease (SCID) that~     eliminates the use of toxic chemotherapy conditioning and maximizes the likelihood of T and~     B cell immune reconstitution. Rather than classic chemotherapeutic agents, the investigators~     will utilize a targeted stem cell mobilizer, plerixafor, in combination with alemtuzumab, a~     monoclonal antibody. Correlative scientific questions will include: 1) efficacy and~     characteristics of host stem cell mobilization; and 2) alemtuzumab pharmacokinetics in very~     young children.~   "
143019|NCT01182610|"~     This is an open-label, Phase II, single-stage study evaluating the use of panitumumab,~     paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal~     adenocarcinoma. The expectation is that this combination will both increase potential~     overall survival by incorporating novel biologic therapy in the neoadjuvant setting and~     decrease potential surgical mortality by eliminating pre-operative radiation therapy.~   "
143020|NCT01182597|"~     Endoscopic hemostasis has been documented by a number of clinical studies to be effective in~     decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed~     adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis~     reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI~     therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar~     acid control as currently recommended intravenous infusion PPI did in patients with bleeding~     ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar~     benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined~     endoscopic hemostasis.~   "
143021|NCT01182584|"~     Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy.~     Pathogenesis involves autoimmune process. The investigators think temperatures of the area~     involved in the inflammation may change. Thus the investigators plan to take temperature~     pictures of Graves' patients using digital infrared thermal imaging system and observe the~     change.~   "
143022|NCT01182571|"~     The purpose of this study is to explore the fatigue, uncertainty, depression and quality of~     life in heart transplant recipients, and associated factors of quality of life .~   "
143023|NCT01182558|"~     The purpose of this investigator-initiated study is to determine the effect of prior muscle~     activation on the response obtained by nerve conduction studies (the compound muscle action~     potential [CMAP]) looking at the amplitude, area, and duration of the CMAP and evaluating~     the length of time the CMAP is larger than at baseline. On the opposite side, the~     corresponding CMAP will be tested periodically, but there will be no muscle activation on~     that side.~      Null Hypothesis: While controlling all possible technical and other known physiological~     variables, prior activation of a muscle has no effect on the amplitude and area of the~     compound muscle action potential (CMAP); and the CMAP does not change over time in the~     relaxed muscle (on the opposite side).~      The investigators suspect that there is an effect of prior activation of the muscle on the~     subsequent CMAP recorded from that muscle.~   "
143024|NCT01182545|"~     The investigators postulated that the use of hyperventilation after induction of anesthesia~     before CO2 insufflation for laparoscopic surgery in Trendelenburg position would maintain~     normocapnia and reduce the hemodynamic percussion response of CO2 insufflation.~   "
143025|NCT01182532|"~     The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine~     (TCM) for treatment of hand, foot, and mouth disease (HFMD).~   "
143026|NCT01182519|"~     The purpose of this study is to find out if there is a link between cigarette smoking,~     inflammation and the spread of breast cancer to the lung. We think that women who are~     current or former smokers may be at increased risk for breast cancer spreading to the lung~     compared to women who have never smoked. Smoking causes inflammation in the lung in some~     women. Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung~     inflammation may increase the chance of breast cancer spreading to the lung. In order to~     find out whether inflammation plays a role in breast cancer spreading to the lung, we will~     measure a urinary marker of lung inflammation. This will allow us to determine if this~     marker is more commonly elevated in women with breast cancer that has spread to the lung~     compared to those without breast cancer in the lung. We will also collect DNA from blood to~     have the opportunity to determine if there are differences in DNA in women with or without~     breast cancer that has spread to the other sites including the lung. We will also collect~     blood to determine if we can identify risk factors for the spread of breast cancer to the~     lungs.~   "
143027|NCT01182506|"~     The purpose of this study is to test a memory training program for breast cancer survivors~     who have problems with memory after receiving chemotherapy. Since breast cancer survivors~     have been reported to have trouble with their memory, a program to help these problems is~     important. Studies have shown that a 5-week software training program improved memory in~     pediatric cancer survivors and other disorders like stroke, but it has not been tested for~     breast cancer survivors. This study will see if breast cancer survivors can improve their~     memory and attention problems by using either one of two software versions of the program.~     One version is called Cogmed Working Memory Training, and the other is a comparison version~     of the software that has the same exercises but is less difficult. People who decide to~     participate in the study will be randomly given one of the two versions.~   "
143028|NCT01182493|"~     The purpose of this study is to evaluate the comparative effectiveness of insulin pump~     therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are~     sub optimally controlled with multiple daily injections (MDI).~   "
143029|NCT01182480|"~     This proof of concept study proposes to evaluate the feasibility of a~     communications-technology-based chronic care and patient relationship management program to~     improve diabetes self management among adult diabetic patients in an urban safety net~     population by providing between-visit reminders and chronic disease support through cell~     phone text messaging.~      The investigators hypothesize that diabetic patients enrolled in the program will be less~     likely to miss scheduled appointments and will have greater perceived self-efficacy and~     improved patient satisfaction concerning chronic disease management. No-show rates among~     patients enrolled in the program are expected to be lower than among patients receiving~     standard care.~   "
143030|NCT01182467|"~     Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S.~     The disease can vary in severity and multiple drug classes are available to the disease~     depending on disease severity and complications. Our purpose will be to study how PET-CT~     scans can be used to better manage Crohn's Disease.~   "
143031|NCT01182454|"~     Blood pressure meter model CH-658 was to be assessed against the standard mercury~     sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.~   "
143092|NCT01181661|"~     The purpose of the study is to develop and test an Internet-based group contingency~     management program designed to promote smoking cessation.~   "
143032|NCT01182441|"~     This is a prospective, randomized, multicenter study to provide additional information on~     the safety and efficacy of the WATCHMAN LAA Closure Technology.~      The PREVAIL study was amended to initiate a prospective, non-randomized continued access~     study titled Continued Access to PREVAIL (CAP2) to collect additional information on the~     safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll~     an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational~     sites in the U.S.~   "
143033|NCT01182428|"~     The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus~     Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on~     clinical outcomes in the treatment of female patients with de novo coronary artery lesions,~     and the characterization of the female population undergoing stent implantation with a~     XIENCE stent.~   "
143034|NCT01182415|"~     Current standard treatments for lymphoma involving the central nervous system include~     chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond~     to this treatment, and some of the patients who do respond relapse after treatment.~      Previous research has shown that a stem cell transplant of a patient's own cells (autologous~     stem cell transplant) may be more effective for some patients with lymphoma involving the~     CNS. In previous research using autologous stem cell transplants for lymphoma involving the~     CNS, a conditioning regimen consisting of the drugs thiotepa, busulfan and cyclophosphamide~     (TCE) was used. These drugs have been shown to enter the nervous system.~      In this research study, the investigators are adding the drug rituximab (Rituxan) to the~     drug cytarabine for the stem cell mobilization process. Cytarabine is a standard drug for~     mobilization. In addition, rituximab will be added to the conditioning regimen of thiotepa,~     busulfan and cyclophosphamide. Rituximab is approved by the FDA for the treatment of some~     types of lymphomas, but is not approved for use in lymphomas that involve the CNS. Rituximab~     is known to be able to enter the CNS. Previous research has suggested that it may help treat~     lymphoma that involves the CNS.~      The goal of this research study is to see if adding rituximab to the stem cell mobilization~     and conditioning regimens helps treat lymphoma that involves the central nervous system.~   "
143035|NCT01182402|"~     The purpose of this study is to improve unsupervised dosing of opioid substitution~     medications. The aim of the study is to examine whether electronic compliance monitoring~     provides some advantages to patients`treatment and what kind of patients especially benefit~     from monitoring. We would also like to know if electronic compliance monitoring can prevent~     the abuse/diversion of medications and how implementing this method to wider treatment~     facilities succeeds.~   "
143036|NCT01182389|"~     Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart~     attack and can cause sudden death. Patients at risk of this rhythm disturbance usually~     receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning~     the heart's rhythm back to normal by electrically stimulating the heart but in doing so~     gives the patient painful and debilitating shocks. The first ICD shock after implantation~     appears to be a powerful predictor of subsequent shock therapy as well as being a predictor~     of of increased mortality in patients with primary prevention ICDs. In patients who receive~     repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that~     causes the problem. However, it is often only performed as a last resort as it is~     technically challenging. We believe that performing VT ablation using the robotic system~     early after the first episode of VT after ICD implantation, may reduce the number of painful~     shocks received by the patient and possibly increase life expectancy and quality of life.~      200 patients from 5 european countries will be recruited in a prospective, open, randomised~     trial. Eligible, consenting patients who have experienced their first episode of VT since~     ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT~     ablation or standard 'conventional' therapy and followed-up every 4 months over two years to~     assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.~   "
143037|NCT01182376|"~     The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in~     the slowing of progression of left atrial and ventricular fibrosis in patients with atrial~     fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.~   "
143038|NCT01182363|"~     This application to the Boston University Medical Center Institutional Review Board outlines~     a research plan devoted to identifying and managing maternal depression in Early~     Intervention (EI). The target population is women who's children are enrolled in early~     intervention who have experienced an adverse pregnancy outcome, defined as the birth of a~     child who was born prematurely, low birth weight, or with birth defects. Early intervention~     provides developmental services to the state's birth to three population under the Part C of~     the Individuals with Disabilities Act (IDEA). Our intervention strategy involves the~     identification of mothers whose children receive early intervention services and who,~     themselves, are at risk for depression. Eligible mothers will be offered a preventative~     intervention that involves the principles of Problem Solving Treatment (PST). Problem~     Solving Treatment is a brief skills-building psychotherapeutic intervention that focuses on~     specific daily problems, and applies to these problems a structured approach to finding and~     evaluating solutions.~      This study will be a parallel group randomized control trial (RCT) of 188 mother-child~     dyads. Mothers in the intervention group will receive 6 sessions of Problem Solving~     Treatment, which will be referred to as Problem Solving Education (PSE) in this application.~     The women in the control site will receive usual care. Problem Solving Education~     interventionists (Problem Solving Educators or PS Educators) will conduct Problem Solving~     Education with mothers of children who receive early intervention services through Thom~     Child and Family Services, Bay Cove Early Intervention program, South Shore Mental Health~     (Step One Early Intervention), and Meeting Street Early Intervention with an enrollment goal~     of 188 mothers. In addition to engaging in Problem Solving Education sessions, mothers who~     agree to participate in the study will meet with research staff to complete 1)baseline~     assessment measures at study enrollment and 2) outcome assessment measures 3 months after~     baseline assessment and 3) outcome assessment measures 6 months after baseline assessment.~   "
143058|NCT01182103|"~     The investigators will (1) detect the associations between brain-derived neurotrophic factor~     (BDNF) DNA methylation, histone modification, depressive symptoms, suicidal behavior and~     antidepressant responses in major depressive disorder (MDD) patients, (2) check the~     correlation between blood BDNF protein and RNA and BDNF rs6265 gene, and (3) discuss the~     possible mechanisms of epigenetic regulation of BDNF in Taiwanese major depressive patients.~   "
143059|NCT01182090|"~     Objective:~      This prospective randomized trial evaluated outcomes of colposacropexy performed either by~     open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical~     techniques, efficacy and overall results are compared.~      Methods:~      In this prospective study 40 consecutive patients with uro-genital prolapse are randomized~     to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage~     is achieved in both groups by two polypropylene meshes.~      Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient~     characteristics, operative and post-operative events and follow-up results are recorded.~   "
143039|NCT01182350|"~     The primary objective of this study is to estimate the overall survival of children and~     young adults with diffuse intrinsic pontine glioma treated (DIPG) with a molecularly based~     treatment strategy, compared to historical controls.~      Four Biopsies of tumor tissue will be obtained by surgical biopsy prior to treatment~     stratification if tolerated. An MRI-guided frameless or frame-based stereotactic biopsy will~     be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal~     route. The exact biopsy location will be determined by the treating neurosurgeon at the~     designated participating site with the goal of minimizing procedural risk.~      Following biopsy,all patients will receive local radiotherapy to consist of 59.4Gy delivered~     using conventional conformal or other standard treatment planning with adjuvant bevacizumab.~     Radiation planning can begin with the pre-operative images. Based upon molecular parameters~     after biopsy, patients will potentially receive erlotinib and/or temozolomide at the start~     of radiotherapy. Bevacizumab will be given concurrently with radiotherapy beginning at least~     three weeks from the biopsy and at least two weeks after the start of radiation therapy to~     ensure that primary wound healing has occurred. Once irradiation is complete, patients will~     have a four week interim period before beginning the maintenance phase. Adjuvant~     chemotherapy will be continued during the interim period.~      The maintenance phase (approxmiately 40 weeks) will last for 10 cycles(28 days +/- 3 days).~     Based upon molecular parameters as determined at the time of diagnostic biopsy, patients~     will continue to receive erlotinib and/or temozolomide along with bevacizumab during the~     maintenance phase.~      Stratification will be based on O6-methylguanine-DNA methyltransferase (MGMT) promoter~     methylation status and epidermal growth factor receptor (EGFR) expression in tumor biopsy~     samples. If MGMT status and/or EFGR status are not determinable, patients may be treated as~     per cohort #1(bevacizumab and irradiation) but will be analyzed separately.~   "
143040|NCT01182337|"~     Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5~     in subjects with early lumbar disc degeneration~   "
143041|NCT01182324|"~     The purpose of this study is to describe the experiences of parents, clinician researchers,~     and industry professionals who were involved in phase II clinical trials of Ataluren for~     Duchenne muscular dystrophy. We are especially interested in learning about motivations for~     being involved in the clinical trial, expectations of the trial, the experience of the~     trial, and relationships between the parents of children involved in the trial, the~     clinician researchers, and PTC Therapeutics. In addition, we would like to learn more about~     whether and how families and advocacy organizations experiences in following the progress of~     the drug, encouraging the clinical trial, and supporting the phase II trials may have~     affected participants thoughts and feelings about the study.~   "
143042|NCT01182311|"~     Background:~        -  The hepatitis B vaccine has been shown to be safe and effective in preventing~          transmission of the hepatitis B virus. Response rates to the initial three doses of the~          vaccine are high, with significant or even complete immune response. However, this~          level has been reported to decline rapidly within the first year and more slowly~          thereafter. There is little data on the durability and long-term protection provided by~          the hepatitis B vaccine administered to adults in the United States.~        -  Vaccinated individuals are believed to be protected against hepatitis B virus infection~          because of a memory immune response. Even if antibody levels are low, the immune system~          will still be able to produce enough antibody to neutralize the hepatitis B virus.~          Therefore, booster doses of the vaccine are not recommended, except for some high-risk~          individuals such as patients on dialysis. Researchers are interested in determining the~          durability of the immune response of the hepatitis B vaccine in adults with low or~          intermediate risk for hepatitis B virus infection.~      Objectives:~      - To examine the long-term immune status of human immunodeficiency virus (HIV) positive and~     negative individuals who received the hepatitis B vaccine during adulthood, compared with~     the immune status of individuals who acquired natural immunity by recovering from acute~     hepatitis B during adulthood.~      Eligibility:~        -  Individuals at least 18 years of age who were vaccinated against hepatitis B at least~          10 years ago.~        -  Individuals at least 18 years of age who contracted and recovered from acute hepatitis~          B at least 10 years ago.~        -  Individuals at least 18 years of age who have well-controlled HIV and were vaccinated~          against hepatitis B at least 10 years ago.~      Design:~        -  Participants will have a single outpatient study visit and potential follow-up visits~          as part of this protocol.~        -  Participants will complete a questionnaire assessing possible risk factors for~          hepatitis B infection, and will provide blood samples to test for hepatitis B~          antibodies and other immune system studies.~        -  Participants will receive a letter or phone call with the results of the blood tests:~        -  Those who no longer have protective levels of antibody against the hepatitis B virus~          will be offered a booster dose of the hepatitis B vaccine. To monitor immune response~          to the booster vaccine, additional study visits will be scheduled at 1 and 3 weeks~          following the booster.~        -  Those who have chronic infection with the hepatitis B virus will be advised to follow~          up with their primary care physician, and may be eligible to participate in ongoing~          treatment trials for chronic hepatitis B.~        -  Those who have abnormal blood tests will be referred back to their primary care~          physician for investigation of the abnormal tests results, and may also be referred to~          other National Institutes of Health protocols.~        -  Additional tests will evaluate immune response to the measles, mumps, and rubella~          (German measles) viruses. Some participants may be advised to have an additional MMR~          vaccine through their primary care physician.~   "
143043|NCT01182298|"~     -  Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA)~          to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who~          have not been previously treated with interferon-alpha drugs (which improve immune~          system response to infection). Ribavirin has been approved by the FDA and is usually~          given in combination with interferon drugs such as peginterferon alfa-2a for treatment~          of chronic HCV.~        -  Recent research shows that Latino whites do not respond as well to treatment with~          peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as~          excessive weight, gender, and insulin resistance were evaluated to explain this~          difference, but research suggests that underlying factors related to Latino or~          non-Latino background, possibly genetic and immune differences, may be affecting the~          response to HCV infection and treatment. However, more research is needed on the~          effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with~          combined and human immunodeficiency virus (HIV) co-infection.~      Objectives:~      - To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and~     ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV~     co-infection.~      This is an observational study. The observed treatment is received and managed through their~     primary care.~   "
143044|NCT01182285|"~     Background:~        -  Patients who have advanced thyroid cancer have a low long-term survival rate. These~          types of thyroid cancer do not respond well to conventional surgery or radiation, or to~          specific thyroid cancer treatments such as radioactive iodine treatment and thyroid~          hormone for thyroid stimulating hormone (TSH) suppression.~        -  Valproic acid has long been approved as an anticonvulsant to treat seizures in patients~          with epilepsy. It has also been used to treat bipolar disorder. Recent studies have~          shown that valproic acid has promising effects in thyroid cancer treatment because it~          may help destroy cancer cells and help conventional treatments be more effective.~          However, valproic acid is not approved for thyroid cancer and is therefore an~          investigational drug.~      Objectives:~        -  To determine whether valproic acid can inhibit tumor growth or induce tumor cell death.~        -  To determine whether valproic acid can make tumor cells increase their uptake of~          radioiodine.~      Eligibility:~      - Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either~     unresponsive to conventional treatments or fails to absorb radioiodine.~      Design:~        -  Eligible participants will continue on the standard thyroid hormone suppression therapy~          and begin receiving valproic acid for a total of 10 weeks. Participants will keep a~          study diary to record doses and side effects, and will have regular clinic visits to~          provide blood samples and receive additional valproic acid.~        -  After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake~          after valproic acid therapy. Tumor biopsies and blood samples will be taken at this~          time.~        -  If there is increased radioiodine uptake on the scan, participants will have additional~          radioiodine therapy.~        -  If there is no increased uptake on the scan, participants will continue on valproic~          acid for 7 more weeks. After 16 total weeks of treatment, additional blood samples and~          scans will be taken. Participants may continue to take valproic acid if the thyroid~          cancer appears to be responding to the treatment.~        -  Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid~          only), and 12 months.~   "
143045|NCT01182272|"~     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating~     patients with liver cancer that can be removed by surgery.~   "
143060|NCT01182077|"~     The objective of the study is to characterize the effect of multiple doses of ASP015K on the~     pharmacokinetics of a single dose of midazolam.~   "
143046|NCT01182259|"~     Tuberculosis remains one of the largest health problems in the world today. Multidrug~     therapy is necessary to cure tuberculosis patients and to prevent the selection of~     drug-resistant mutants, however, which may increase the incidence of side effects during the~     course of treatment. These side effects may be mild as well as fatal. A severe side effect~     against one of the anti-TB drugs, which influences drug compliance, may lead to the~     discontinuation of that drug. At the same time, the risk of treatment failure and relapse~     are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the~     related risk factors is crucial. Awareness of the risk groups may decrease the incidence of~     serious drug-related side effects and medical cost.~      The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended~     by WHO, which simplify the prescription of drugs and prevent the development of drug~     resistance. However, the FDC regimen is not consistent with the dosages that are usually~     given, the higher risk of drug toxicity and adverse reactions should be considered. To our~     knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan.~     The aim of the present study is to investigate the current incidence of side effects and the~     risk factors related to FDC drugs for side effects during the initial phase of therapy.~   "
143047|NCT01182246|"~     The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in~     combination with gemcitabine standard therapy, in patients with advanced or metastatic~     cancer of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these~     patients will also be studied.~   "
143048|NCT01182233|"~     The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel,~     targeted means administering a variation of total body irradiation (TBI) radiation i.e.,~     total skeletal irradiation (TSI) administered by helical tomotherapy (HT) before, and in~     addition to the current standard of HDC, at a dose of 200 mg/m2 (HDMel200). The underlying~     postulate of this endeavor is that TSI-HT will provide additional cytoreduction to HDMel~     alone, without producing additional (serious) toxicity. We will utilize a classical Phase I~     study design (i.e., dose escalation) in myeloma patients undergoing AHSCT2 to define a~     maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Finally, although comparisons~     to other therapies are not typical (and/or feasible) for a Phase I study, we will compare,~     whenever possible, both the toxicity and the antimyeloma activity of the AHSCT2 to AHSCT1.~      This protocol will standardize, as much as possible the use of AHSCT2 both as a tandem and~     salvage procedure. Since sufficient AHSC (CD34+ cells) are routinely collected in adequate~     numbers for multiple AHSCTs, but recently used infrequently, it is important to work towards~     defining the optimal utilization of this resource.~   "
143049|NCT01182220|"~     1. labor epidural quite often require bolus supplementation for better pain control~          control. Quite often this is due to sparing of sacral nerves.~        2. If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize~          bolus requirement and improve patient labor experience.~   "
143050|NCT01182207|"~     This study was designed to compare the relative bioavailability (rate and extent of~     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets~     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult~     subjects under non-fasting conditions.~   "
143051|NCT01182194|"~     This study was designed to compare the relative bioavailability (rate and extent of~     absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets~     (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult~     subjects administered under fasting conditions.~   "
143052|NCT01182181|"~     The objective of this study is to evaluate the comparative bioavailability between~     Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca~     Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.~   "
143053|NCT01182168|"~     The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus~     (also called RAD001) at different dose levels. We want to find out what effects, good and/or~     bad, this treatment has on you and your cancer.~      Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat~     advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the~     pathways in cancer cells that make tumors grow. Laboratory studies have shown that~     Everolimus appears to improve the activity of cisplatin against cancer cells.~   "
143054|NCT01182155|"~     Patients treated with radiation therapy for lung tumors can experience inflammation after~     treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in~     the composition of exhaled breath in patients undergoing radiotherapy. If changes can be~     detected, this may ultimately serve as biomarkers for identifying patients at highest risk~     for radiation-induced lung injury (radiation pneumonitis).~   "
143055|NCT01182142|"~     Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of~     metastatic breast and colorectal cancers. The role of capecitabine in treatment of~     metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of~     capecitabine in metastatic renal cell carcinoma patients.~   "
143056|NCT01182129|"~     Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General~     White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial~     blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8~     hours after administration for determination of nicotine. Mean + SD extracted dose of~     nicotine from each preparation will be estimated. The percentage extracted of the nicotine~     content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg~     chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in~     relation to the dose following the 4 mg Nicorette chewing gum will be calculated.~     Self-reports of subjective effects will be obtained up to 30 minutes after the test product~     is administered using a 100 mm visual analogue scale (VAS) anchored with not at all to~     extremely. Study hypothesis is that Cmax and AUC of Nicorette 4 mg chewing gum and Swedish~     snus are similar.~   "
143057|NCT01182116|"~     The side to end anastomosis has become popular in recent years as it is technically simple~     to construct. The difference between the Baker type(side to end) of anastomosis and the J~     pouch, is that no formal pouch is constructed in the side to end. It has one staple line and~     the anastomosis.~      The investigators hypothesis is that the patients who receive a side to end anastomosis have~     bowel outcome and quality of life that is equivalent to those who receive a J pouch.~   "
143061|NCT01182064|"~     Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial~     infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a~     coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or~     their damage in the cardiac injury repair. The investigators objectives are to know the PAMI~     incidence, make an approximation to PAMI pathophysiology, and propose management strategies.~   "
143062|NCT01182051|"~     The primary aim of this proposal is to refine the intervention under investigation (i.e.,~     family-based CBT) and evaluate the feasibility and acceptability of the intervention and~     methods (e.g., recruitment, assessments).~      The secondary aim of this proposal is to compare the relative efficacy of an 8 session~     family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing~     anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT~     will result in greater reductions in both anxiety and headache frequency and severity~     compared to RT.~   "
143063|NCT01182038|"~     The purpose of this study is to determine whether birth on a birthing seat will effect~     numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of~     artificial oxytocin for labour augmentation and fetal outcomes.~   "
143064|NCT01182025|"~     The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for~     mild type of hand, foot, and mouth disease.~   "
143065|NCT01182012|"~     Background:~      Patients with severe mental illness (SMI) have a higher prevalence of cardiovascular risk~     factors (CVRF) than the general population and a control of these risk factors poorer.~     Serious mental illness often causes health teams to focus interventions in mental illness~     and put aside the CVRF.~      Objectives:~      This project aims to assess the CVRF, stratify the cardiovascular risk, adequate drug~     treatment to reduce this risk and evaluate the effectiveness of an intervention by~     professional community nurses in patients with SMI.~      Materials and Methods:~      Prospective study of a cohort of patients over 18 years with a diagnosis of SMI with two~     cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. The~     investigators calculate the risk to the cardiovascular risk tables with the SCORE~     (Systematic Coronary Risk Evaluation) for countries of low cardiovascular risk and the of~     Framingham REGICOR (Heart registry of Girona, Spain). The adequacy of pharmacotherapy will~     be assessed contrasting it with the recommendations of the Program of Preventive Activities~     and Health Promotion of Family medical association. The intervention will be conducted by~     professional nurses and consist of an initial psycho-educational intervention, and two more~     reinforcement throughout twelve months, of duration less than 30 minutes that will be~     addressed in an integrated manner the clinical situation with regard to cardiovascular risk.~     If necessary, pharmacological treatment will be prescribed. Twelve months after the first~     intervention, a second evaluation on cardiovascular risk and the effectiveness of the~     intervention will be performed.~   "
143066|NCT01181999|"~     Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)~     combination is considered as the new gold standard for the first-line treatment of elderly~     patients with diffuse large B-cell lymphoma (DLBCL).~      The study is aimed to evaluate the overall response rate and the safety of four cycles of~     R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in~     newly diagnosed DLBCL patients with aged more than 70 years.~   "
143067|NCT01181986|"~     The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes~     medication, will improve the function of the innermost part of the arterial wall called the~     endothelium after a fat-enriched meal and to determine how this occurs. The results of this~     study will help to determine and understand a novel action of this group of diabetes~     medications based on the action of naturally occuring gut substances called incretins. This~     may have a significant impact on cardiovascular health in patients with early and~     longstanding diabetes.~   "
143068|NCT01181973|"~     The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to~     that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg~     vial is safe and well-tolerated.~   "
143069|NCT01181960|"~     The purpose of this study is to build a data repository that can be used to understand~     pharmaceutical utilization patterns among patients being treated in community behavioral~     health organizations (CBHOs) for schizophrenia or bipolar I disorder.~   "
143070|NCT01181947|"~     The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System~     (Captivia). This new delivery system was CE marked on September 14th, 2009 and was~     commercially released in the European Union on October 1st, 2009.~      The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is~     designed to treat diseases of the descending thoracic aorta including but not limited to~     aneurysms and dissections.~      The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical~     performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market~     approval.~   "
143071|NCT01181934|"~     This study in young and elderly healthy subjects will investigate the effect of nicotine on~     arousal, cognitive task and social cognition after acute dose administration.~   "
143072|NCT01181921|"~     The purpose of this study is to assess the modulating effect of galantamine on circadian~     rhythm in patients with moderate Alzheimer's disease.~   "
143073|NCT01181908|"~     The purpose of this study is understand the effects of GSK114814 and alcohol in healthy~     volunteers when taken together.~   "
143074|NCT01181895|"~     The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation~     powder administered once daily in the evening in adolescent and adult subjects 12 years of~     age and older with persistent asthma over a 12-week treatment period.~   "
143075|NCT01181882|"~     The purpose of this study is to understand if omega-3 fatty acids in fish oil enhance the~     ability of aspirin to reduce the risk of cardiovascular diseases such as heart attack and~     stroke in those who have diabetes mellitus.~   "
143076|NCT01181869|"~     An observatory of patients registered in 22 local homecare associations in France, for~     respiratory diseases, with annual data update. Demographic and clinical data are registered~     rendering possible extraction of clinical and prognostic data.~   "
143077|NCT01181856|"~     This is a phase I study that will compare the safety and immunogenicity of candidate~     tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal~     route in healthy adult individuals who have been previously vaccinated with Bacillus~     Calmette-Guerin (BCG).~   "
143078|NCT01181843|"~     This study is designed to determine the incidence and severity of respiratory depression in~     elective cesarean section patients who have received a spinal or epidural narcotic called~     duramorph for management of postoperative pain. A monitoring device called a capnograph as~     well as a device called a pulse oximeter is placed on the patient once in the recovery room~     after delivery. The capnograph monitors the carbon dioxide level that the patient breathes~     out as well as their respiratory rate. The pulse oximeter is a device that is taped on the~     patient's finger and measures their oxygen saturation level. The monitoring is maintained~     for 18-24 hours after surgery.~   "
143079|NCT01181830|"~     Magnesium is the second most abundant ion in human cells and plays fundamental roles in~     several enzymatic reactions: it is involved in ATP production, in the phosphorylation of~     proteins, in glucose metabolism and in the contraction of cytoskeleton.~      Several epidemiological studies demonstrated that low dietary magnesium intake is inversely~     associated with diabetes mellitus, hypertension and metabolic syndrome.~      Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular~     level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus~     its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium~     is involved in the physiopathological mechanism of insulin resistance, through a reduction~     in cellular uptake of glucose. This condition and the subsequent compensatory~     hyperinsulinemia can ultimately lead to increased synthesis of proinflammatory cytokines and~     to endothelial dysfunction. Thus, magnesium depletion and subsequent alterations can~     increase the risk of developing vascular disease such as atherosclerosis and has been~     associated with cardiovascular events.~      Several clinical trials have explored the possible beneficial effect of magnesium~     supplementation on blood pressure, plasma lipids and insulin resistance but the results are~     often contradictory. One of the possibilities for these unclear results could be that in~     some of them the interventions started too late when haemodynamic and metabolic changes are~     more difficult to revert.~      The investigators hypothesis is that magnesium supplementation in a population at increased~     genetic risk of developing metabolic syndrome but without it could improve blood pressure~     and the other metabolic syndrome related components.~      Thus, the aim of the present study is to evaluate the effect of oral supplementation of~     magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a~     sample of 15 subjects who are at increased risk of developing metabolic syndrome since have~     a positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI~     criteria).~   "
143080|NCT01181817|"~     Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect~     tools to investigate the changes in the brainstem and brain evoked by the orthodromically~     impulses of a SCS.~   "
143081|NCT01181804|"~     This is a single-dose, randomized, cross-sectional comparison study examining the relative~     safety and resulting blood level profiles after administration of a new boceprevir tablet~     formulation versus its current capsule formulation for treatment of chronic hepatitis C. In~     Part 1 of the study participants will receive boceprevir tablets and capsules under fed~     conditions. In Part 2 of the study a new group of participants will receive boceprevir~     tablets and capsules under fasted conditions.~   "
143082|NCT01181791|"~     This application a phase II clinical trial to address the possible active mechanisms of~     probiotics and to obtain preliminary efficacy and safety data after the administration of a~     probiotic, Lactobacillus reuteri a population of premature infants.~      The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature~     infants will lead to clinical beneficial effects by modifying their intestinal microbiota~     and enhancing their intestinal immunological response.~   "
143083|NCT01181778|"~     Physicians counsel women participants who are candidates for hormonal contraception about~     available combined hormonal contraceptive methods (the combined pill, the contraceptive~     vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive~     transdermal patch). Effects of this counseling on women's contraceptive use decisions are to~     be evaluated by 1) recording which method is chosen after information is provided about all~     three available combined hormonal methods, 2) comparing the final chosen contraceptive~     method used by a participant after counseling with the method originally intended to be used~     by that participant before the counseling, and 3) evaluating the criteria used by women~     participants to choose their contraceptive method after the counseling, including evaluation~     of social and demographic predictors of contraceptive choice. The differences among~     participants in the number of contacts made by the participants to physician offices for~     purposes of obtaining information regarding the use of their final chosen hormonal~     contraceptive (e.g., requests for clarification, questions, expressing doubt or reservations~     for using the method, or requests for other help/advisement by the physician) will also be~     evaluated over four months following the physician counseling.~   "
143084|NCT01181765|"~     This is a pilot study to estimate the efficacy of infliximab in inducing and maintaining~     healing of lesions in the mucosa of subjects with Crohn's disease involving their small~     bowel.~   "
143085|NCT01181752|"~     Eye drops must be proficiently instilled to prevent infections following cataract surgery.~     Proficiency is defined as placing a drop on the ocular surface without touching the~     applicator's tip. Researchers will investigate whether patients can proficiently administer~     eye drops on the first attempt on the first day after surgeries. If successful, researchers~     will determine how proficient they are 29 days later. If not, they will be provided with~     additional educational sessions and tested again 29 days later. Researchers will also~     determine if the proficiency of instillation correlates to whether patients experience~     irritation or pain after surgery.~      Summary Brief Summary Eye drops must be proficiently instilled to prevent infections~     following cataract surgery. Proficiency is defined as placing a drop on the ocular surface~     without touching the applicator's tip. Researchers will investigate whether patients can~     proficiently administer eye drops on the first attempt on the first day after surgeries. If~     successful, researchers will determine how proficient they are 29 days later. If not, they~     will be provided with additional educational sessions and tested again 29 days later.~     Researchers will also determine if the proficiency of instillation correlates to whether~     patients experience irritation or pain after surgery.~      Hypotheses:~      On postoperative day 30, there will be a higher rate of successful eye drop instillation in~     the group of subjects who receive the educational session compared to the baseline group~     subjects (subjects only tested on postoperative day 30 rather than both the first day after~     surgery and postoperative day 30) who will not receive it.~      In comparing the postoperative day 30 proficiency levels of baseline subjects and subjects~     who were able to proficiently instill a single eye drop on postoperative day 1, the subjects~     who were able to proficiently instill a single eye drop on postoperative day 1 will have a~     higher success rate than the baseline group.~      The number of subjects who are unable to correctly instill the medication on postoperative~     day 30 and experienced pain or irritation before or during postoperative day 30 will be~     higher than the number of subjects who are able to correctly instill the medication on~     postoperative day 30 and experienced pain or irritation before or during postoperative day~     30.~   "
143086|NCT01181739|"~     This study is designed to compare traditional Colonoscopy with CT Colonography, commonly~     known as virtual colonoscopy. The study will compare the ability of both procedures as~     screening tests to identify polyps in the colon in patients at average risk for developing~     polyps. The patient preferences for each procedure will be assessed by means of a~     standardized questionnaire. As well the ability observers with differing levels of~     experience to read the CT scans and detect polyps will be compared. All patients will~     receive both CT scans and traditional colonoscopy on the same day.~   "
143087|NCT01181726|"~     The objective of this study was to determine and compare the rate and extent of absorption~     of norethindrone and unconjugated estradiol from a test formulation of~     Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg~     estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions.~   "
143088|NCT01181713|"~     The purpose of this study is to determine if antibiotic resistance of the ocular surface~     flora to the 4th generation fluoroquinolones will increase after repeated use of topical~     antibiotics for three days post intravitreal injection.~   "
143089|NCT01181700|"~     The purpose of this study is to investigate the time course of PF-00241939 concentrations in~     the blood following dosing by oral inhalation using dry powder inhalers.~   "
143093|NCT01181648|"~     The investigators are doing this study to learn about the quality of life patients have at~     the end of treatment. Some patients' cancers are related to human papilloma virus or HPV;~     others are not. HPV is a virus that can be sexually transmitted and is known to cause some~     types of cancers. If your throat cancer was related to HPV, your doctor can discuss this~     with you in detail. The investigators want to see if there are differences in quality of~     life between patients whose cancers are caused by HPV and those who cancers are not caused~     by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by~     HPV. The investigators believe that patients with these two different types of throat cancer~     will also have different experiences after completing therapy. The investigators would like~     to understand what those differences are. The long-term goal of this study is to see what~     symptoms most patients have. The investigators can then try to treat them earlier, and~     hopefully, improve the symptoms. The investigators will also be able to plan more research~     to improve treatment for symptoms following treatment for cancer of the mouth and throat.~   "
143094|NCT01181635|"~     The purpose of this study is to examine if psychotherapy can reduce sickness absence.~   "
143095|NCT01181622|"~     The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID~     in pediatric CF patients 2 to 4 years of age~   "
143096|NCT01181609|"~     This study will assess the efficacy and safety of intravenous Avastin in combination with~     chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum.~     The anticipated time of study treatment is until disease progression.~   "
143097|NCT01181596|"~     Use of a new ultrasound device designed for babies to look at the catheters in veins and~     arteries as well as the blood vessel itself. An observational study to assess the the~     clinicians perception of the ultrasound image quality as a tool to detect catheters in~     vessels.~   "
143098|NCT01181583|"~     The overall aim of this study is to develop and test a tailored Internet-delivered~     psychological treatment for patients with mild to moderate major depression and comorbid~     anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active~     control group.~   "
143099|NCT01181570|"~     This study will evaluate the effect and safety of adalimumab in approximately 20 subjects~     with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment~     center located in Montreal.~      Patients with psoriasis often have additional disorders such as obesity. Obese patients are~     more at risk of developing obstructive sleep apnea. This is believed to be caused by both~     the collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently~     approved by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha~     (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is~     believed that adalimumab could improve obstructive sleep apnea by lowering the levels of~     TNF-alpha.~   "
143100|NCT01181557|"~     The aim of the present prospective study was to evaluate the prediction accuracy of EORTC~     QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to~     investigate how the quality of life (QoL) of patients with rectal cancer changes with time~     after cancer or after stomia.~      Eligible subjects were consecutively enrolled in the investigators' Institute and subjected~     to EORTC QLQ-C30/C38 questionnaire.~   "
143101|NCT01181544|"~     During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of~     this pilot study is to determine if the amount of heparin administered during a patient's~     hemodialysis can be individualized using an equation for heparin dose adjustment.~   "
143102|NCT01181531|"~     The purpose of this study is to determine the efficacy of treatment with cinacalcet to~     manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given~     orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when~     the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with~     currently recommended ranges.~   "
143103|NCT01181518|"~     The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by~     the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.~   "
143104|NCT01181505|"~     This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in~     healthy subject in relation to the presence of HNF-4A G60D variant.~   "
143105|NCT01181492|"~     Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on~     metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176~     patients receiving elective lower abdominal surgery under general anesthesia were recruited~     into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma~     fentanyl concentration was detected 30 min after anesthesia induction by high performance~     liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for~     pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24~     h after operation. PCA fentanyl consumption and adverse effects were recorded during the~     first 24 h after surgery.~   "
143106|NCT01181479|"~     The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal~     contraceptive delivery system containing ethinyl estradiol and levonorgestrel.~   "
143107|NCT01181466|"~     The purpose of this study is to assess the procedural and post-procedural safety and~     efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in~     patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.~   "
143108|NCT01181453|"~     This study randomly assigns patients with diabetic foot ulcers to receive standard therapy~     (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus~     Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an~     absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment~     period is complete.~   "
143109|NCT01181440|"~     This study randomly assigns patients with plantar diabetic foot ulcers to receive~     conventional therapy (debridement, infection control, saline-moistened gauze dressings, and~     standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is~     a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh.~     Patients are evaluated weekly until Week 12, then every four weeks until Week 32.~   "
143110|NCT01181427|"~     Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected~     subjects.~   "
143112|NCT01181401|"~     This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF~     induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by~     radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region~     (oro-hypopharynx carcinoma, cancer of the oral cavity).~      The primary objective of the study is to assess the feasibility of an experimental~     'fractionated' TPF regimen compared to a current standard TPF regimen.~      Composite endpoint of compliance and feasibility in terms of~        -  response (RECIST1.1) and~        -  hematological acute toxicity (CTCAE v.4.02)~        -  on time application of RAT following an experimental or standard TPF IC.~      Secondary endpoints are~        -  Treatment intensity achieved~        -  Toxicity (according to CTCAE v.4.02)~        -  Response rates after completion of induction chemotherapy and after completion of~          entire protocol treatment (RECIST1.1)~        -  Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after~          randomisation~        -  Quality of life according to EORTC QoL C30 & HN35~      The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients~     in total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN.~     Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together~     with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.~   "
143113|NCT01181388|"~     Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce~     bleeding complications in AMI patients.~   "
143114|NCT01181375|"~     The experiments outlined in this proposal will compare a number of currently available~     techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix~     cancer. The aim of these experiments is to establish the relationship of the clinically~     relevant outcome measures of tumour control and survival following radiation therapy with~     these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia.~     These characteristics will be assessed in patients undergoing treatment using techniques~     which have reached an appropriate level of development for clinical evaluation and aim to~     determine the best technique for determining these parameters of the tumour~     microenvironment. A number of novel strategies directed at the microenvironment are~     undergoing or soon will be undergoing clinical evaluation and selection of appropriate~     patients for these trials is of great importance.~   "
143115|NCT01181362|"~     Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes~     defined on this volumetric information data set. However, target delineation also depends on~     disease seen endoscopically which may not be visible on CT. We are developing imaging and~     tracking technology to improve target delineation in Radiation Therapy (RT) planning for~     head & neck cancer using quantitative registration of 2D endoscopic information with CT~     data. Diagnostic endoscopy is performed in the upright position. CT images and radiation~     delivery are obtained with the patient in the supine position. The accuracy of the~     registration will be improved if performed in the same position to prevent mobile soft~     tissue structures shifting between the upright and supine positions. Since therapy must be~     performed in the supine position, we intend to check the feasibility of performing endoscopy~     in the supine treatment position. We will compare and assess patient comfort and endoscopic~     sightlines during an endoscopy procedure in both the upright and supine positions.~   "
143116|NCT01181349|"~     This is a multicenter, observational study in adult participants undergoing different types~     of elective surgical procedures requiring general anesthesia. During the first study period,~     there will be a cross-sectional evaluation of neuromuscular blockade level upon participant~     arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital~     discharge data from the participants will be collected. The purpose of this study is to~     determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia~     at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.~   "
143117|NCT01181336|"~     The purpose of this study is to see whether a single vaccination (injection) with the~     investigational influenza vaccine is safe in healthy subjects. The study is also designed to~     evaluate four different dose formulations of the vaccine to see which gives the best immune~     response.~   "
143118|NCT01181323|"~     The purpose of this research study is to learn more about the safety of 2 licensed flu~     vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to~     women who are breastfeeding and to compare the immune response (body's defense against~     foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with~     breastfeeding mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120~     days post delivery) who plan to breastfeed through 28 days post vaccination and who have not~     received influenza vaccine for the influenza season for which they are being enrolled, will~     be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal~     spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal~     spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids.~     Participants will be involved in this United States based study for about 6 months.~   "
143119|NCT01181310|"~     The drug, scopolamine, can result in short-term impairments of cognitive function,~     attention, and memory that resemble those seen in aging and Alzheimer's disease. This study~     tested the capability of both individual and combined doses of MK-3134 and the current~     standard treatment: donepezil (Aricept), to reverse such impairments, following a single~     dose of scopolamine. Participants were evaluated after each of 5 different treatment periods~     (in a cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and~     MK-3134 (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both~     donepezil (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by~     scopolamine SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil~     (PO) followed by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the~     same over all treatment arms in which the specified drug was administered. There were 8~     total visits for each treatment period, including 5 Treatment Visits requiring 14-day~     intervals between visits for study-drug washout. Participants were assessed for cognitive~     function before and after each treatment period during the Treatment Visits.~   "
143120|NCT01181297|"~     The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed~     formula with an added probiotic in children with documented milk allergy.~   "
147724|NCT01120782|"~     The purpose of this study is to determine whether the prescription determined for a new~     daily disposable toric contact lens will be a good match to a prescription determined for an~     existing brand of lens.~   "
143121|NCT01181284|"~     Patients with pulmonary arterial hypertension(PAH) suffer from chronic shortness of breath,~     and have impaired survival related to progressive right ventricular failure. Abnormal~     vasoreactivity to nitric oxide(NO) plays a role in the pathophysiology of PAH.~     Phosphodiesterase Type 5 Inhibitor (PDE5 inhibitors) sildenafil have been shown to be~     beneficial in PAH, but extent of benefit is variable.~   "
143122|NCT01181271|"~     Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma~     after autologous transplantation. Non-myeloablative allogeneic transplantation allows~     patients to receive an infusion of donor cells in an attempt to induce a graft versus~     lymphoma effect. This study will assess the feasibility, safety and efficacy of the~     combination of autologous stem cell transplantation followed by non-myeloablative~     transplantation for patients with poor-risk aggressive lymphoma.~   "
143123|NCT01181258|"~     In this study the investigators investigate a cell therapy strategy that could harness~     allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators~     have designed a novel lymphodepleting conditioning regimen followed by infusion of~     donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with~     refractory lymphoid malignancies.~   "
143124|NCT01181245|"~     Objectives~        -  Primary: To evaluate the safety and tolerability of FG-3019 in combination with~          gemcitabine and erlotinib~        -  Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with~          gemcitabine and erlotinib~   "
143125|NCT01181232|"~     The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified~     release) compared to zolpidem IR (immediate release) in patients with primary insomnia.~   "
143126|NCT01181219|"~     Transepithelial CXL (performed without epithelial removal) seem to have similar clinical~     effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal).~     The current study attempts to prove that hypothesis.~      A prospective, controlled, randomized, contralateral trial, will involve one eye of the~     patient to be treated with transepithelial CXL, while the control eye will be treated with~     the standard CXL. Totally 20 patients (age >18 and <40 years) referred by an ophthalmologist~     to the eye department of the University Hospital North Norway for CXL treatment of bilateral~     progressive keratoconus, will be recruited.~   "
143127|NCT01181206|"~     BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the~     numbers of surgical site infections in two different techniques of covering the abdominal~     wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved~     3M™ Steri-Drape™ Wound Edge Protector.~   "
143128|NCT01181193|"~     This is non-randomized phase 2 study to assess efficacy and toxicity of long term high dose~     vitamin D3 given concurrently with chemo-radiotherapy (CCRT) containing temozolomide~     followed by adjuvant chemotherapy (ACT) with temozolomide in patients with newly diagnosed~     glioblastoma multiforme GBM). Preoperative diagnosis of GBM will be based on magnetic~     resonance imaging (MRI) brain scan. All patient will underwent craniotomy with partial or~     total resection of a visible tumour mass. All patients will be planned for postoperative~     three-dimensional conformal RT (3-DCRT) or intensity-modulated RT (IMRT) to residual tumour~     and/or resection bed. A total RT dose of 54-60 Gy will be delivered using 2 Gy daily~     fractions given over 5 days a week. Daily chemotherapy with temozolomide in the dose of 75~     mg/m2/day will be started at the first day of RT, and will be continued for entire period of~     RT inclusive week-end breaks. ACT will contain 6 cycles of oral temozolomide 150-200~     mg/m2/day given for 5 days every 4 weeks. Oral vitamin D3 will be administered in daily dose~     of 4000 IU. Vitamin D3 therapy will be started 1 week prior to commencing CCRT, and will be~     terminated immediately after completing last cycle of ACT. MRI scan of the brain will be~     performed at 4 months after completing CCRT, and than will be repeated every 4 months for~     first 2 years, and every 6 months for subsequent years. The study participants will be~     followed until disease progression or death. The study is expected to complete within 4~     years.~   "
143129|NCT01181180|"~     Experimental design overview The proposed project is a prospective experimental RCT study~     design. Independent old adults(age 65 years old and older) who do not suffer from balance~     problems willing to participate in the study will be tested before and after water~     consumption to explore whether there are differences in balance control as a result of~     dehydration.~   "
143130|NCT01181167|"~     The objective of this study is to assess the efficacy and safety of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective~     total hip arthroplasty.~   "
143131|NCT01181154|"~     The hypothesis based on retrospective data is that, the rate of overall response-rate (PR +~     CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm~     (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013)~     over a 3 year period (amendment n°3 - 11/12/2012).~   "
143132|NCT01181141|"~     The objective of this study is to evaluate the safety and efficacy of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective~     hip fracture surgery.~   "
143133|NCT01181128|"~     The primary objectives of this study are: to evaluate the safety and tolerability of~     rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and~     surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis~     regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3)~     and surgical treatment regimen. The secondary objectives of this study are: to characterize~     the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed~     product, Advate®; to characterize the range of dose and schedules required to adequately~     prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to~     treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.~   "
143134|NCT01181115|"~     The study is designed to determine the effect of weekly intramuscular (IM) administration of~     30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and~     T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with~     clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).~   "
143135|NCT01181102|"~     The objective of this study is to assess the efficacy and safety of DU-176b compared with~     enoxaparin sodium for the prevention of venous thromboembolism in patients after elective~     total knee arthroplasty.~   "
143137|NCT01181076|"~     Aim~      Allogeneic stem cell transplantation (allo-SCT) combined with several cycles of intensive~     chemotherapy is the only curative treatment for several malignant blood diseases. Most~     allo-SCT patients who are treated with intensive chemotherapy often have reduced nutritional~     status. Several studies have evaluated the effect of different nutrition intervention for~     allo-SCT patients, but there have not been found evidence-based recommendations for energy~     requirements, use of enteral nutrition (EN) and/or parenteral nutrition (PN). We are not~     aware of studies using QoL as end-point among allo-SCT patients allocated to specific~     nutrition intervention.~      Main hypothesis:~      Patients who receive individualized nutrition have better global QoL assessed with the~     European Organisation for Research and Treatment in Cancer (EORTC) QLQ-HDC29 tool three~     months after SCT~      Sub-hypotheses:~      Patients who receive individualized nutrition have:~      i) less often oral mucositis grade 3-4. ii) better nutrition status iii) decreased length of~     hospital stay, less episodes with fever, earlier engraftment and less often acute graft~     versus host disease (GVHD) grade 3-4, and iv) better main QoL scores on the scale for~     physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea~     three months after allogeneic SCT, compared to the control group.~      Patients and methods A minimum sample of 100 patients will be included in the study. The~     patients enrolled in the study will be randomly assigned to the intervention- or control~     group. The patients in the intervention group will receive a therapeutic diet in combination~     with tube feeding with an additional PN if the estimated requirements by the enteral route~     is lower than reference values. The patients in the control group will receive nutrition~     support after established routine, first by the oral route, later by the PN route.~   "
143138|NCT01181063|"~     Due to the complexity of orally inhaled products (combination of a formulation and a~     device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo~     correlation(IVIVC) for inhaled dosage forms is not generally known.~      The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH~     product variants under development and compare pulmonary deposition (administration with~     charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.~   "
143139|NCT01181050|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the clinical~     efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid~     arthritis (RA).~   "
143140|NCT01181037|"~     A retrospective study to compare clinical results of patients that were treated by Bipolar~     H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for~     displaced femoral subcapital fracture.~   "
143141|NCT01181024|"~     This randomized, double-blind, placebo controlled, 3 part study will assess the safety,~     tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with~     chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized~     to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers~     will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout~     period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients~     with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5~     days.~   "
143142|NCT01181011|"~     To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5)~     dose combination after single dose in healthy Chinese subjects.~      To determine whether a pharmacokinetic interaction exists between telmisartan and~     amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5)~     tablet alone and in combination, in healthy Chinese subjects.~      To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy~     Chinese subjects.~   "
143143|NCT01180998|"~     The purpose of this study is to evaluate the clinical performance, defined as successful~     fit, of two toric contact lenses (one daily disposable and the other daily wear reusable~     contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact~     lens drop-outs, and non-users of toric contact lenses (neophytes).~   "
143144|NCT01180985|"~     The purpose of this study is to compare visual acuity and redness of eyes between a~     prototype contact lens and an already marketed contact lens.~   "
143145|NCT01180972|"~     This is a pilot community-based research study to examine the effects of specific~     environmental and social factors on physical activity, fitness, and health of middle school~     Hispanic children living in an inner-city community.~   "
143146|NCT01180959|"~     The goal of this clinical research study is to learn if the combination of AvastinTM~     (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver~     cancer. The safety of this drug combination will also be studied.~   "
143147|NCT01180946|"~     Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate~     and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are~     in adolescent girls and how these levels vary with other hormonal measurements. We will also~     be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin~     D alters the levels of FGF23 and other factors including insulin resistance.~   "
143148|NCT01180933|"~     Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic~     acid, both or a placebo during the second half of pregnancy. Biochemical measures are~     determined in maternal blood during pregnancy and in cord blood.~      Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years~     focus on long term effects of supplementation anthropometric development, neurological~     development and allergy risk.~   "
143149|NCT01180920|"~     The goal of this study is to determine the clinical importance of Periostin in oral health~     and disease. The long-term goal will be to develop practical applications for the diagnosis,~     treatment, prevention and cure of human periodontal diseases.~   "
143150|NCT01180907|"~     The purpose of the study is to determine whether positron emission tomography using the new~     imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.~   "
143151|NCT01180894|"~     The purpose of this clinical trial is to determine whether intravenous iron supplementation~     of anemic, critically ill trauma patients improves anemia and reduces the need for a red~     blood cell transfusion.~   "
143152|NCT01180881|"~     The aim of this study is to follow up with all of the pediatric brain tumor patients who~     received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which~     there is baseline neuropsychological testing in order to measure changes, if any, in~     neurobehavioral functioning (executive skills, emotional/behavioral functioning, and~     adaptive abilities) and their use of special education services at one year or more~     post-treatment. The investigators will also correlate neurobehavioral data with pertinent~     clinical information. Participation will be maximized through the use of mail-in, parental-~     and self-report questionnaires.~   "
143153|NCT01180868|"~     The purpose of this study is to determine the biodistribution of a new agent 1-L-(2~     deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate~     whether it can be used to image cancer, autoimmune disease, and inflammation~   "
143154|NCT01180855|"~     The specific aims of the proposed study are to compare the sleep, daytime functioning, and~     circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin~     receptor agonist in humans alone and in combination with multi-component behavior therapy~     (MCBT) in patients with chronic insomnia.~   "
143155|NCT01180842|"~     The investigators research question is whether or not yoga effectively alleviates symptoms~     of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga~     does prove to be effective, the investigators will educate our CF population about the~     benefits they may experience if they choose to incorporate yoga into their CF therapy. The~     investigators will also go on to do further research of other complementary alternative~     medicine therapies.~      This is a pre/post-test study with 20 subjects. The subjects will serve as their own~     controls. Each subject will participate in six yoga sessions over a ten week period.~     Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will~     also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is~     affected by stress. Testing of cortisol throughout the study will help us determine the~     subjects' stress level throughout the study.~   "
143156|NCT01180829|"~     This study will provide a pilot test of two different text message interventions for problem~     drinkers. Participants will be recruited using a general population telephone survey.~     Participants in a control group (who will not receive text messages) will be compared to~     participants who receive one of two different types of text message packages (12 text~     messages sent once per week in each) - a series of personalized feedback text messages or a~     series of consciousness raising test messages (i.e., messages that keep the thought of~     cutting down on their drinking in the participants' mind). Participants in the three~     different conditions will be followed-up in three months time to assess changes in drinking.~     It is predicted that participants who receive either of the text message packages will~     report reduced drinking as compared to those participants in the control condition who do~     not receive any text messages.~   "
143157|NCT01180816|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic~     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of~     tumors also exhibits the most aggressive behavior, resulting in median overall survival~     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy has consisted~     of surgical resection, external beam radiation or both. More recently, a Phase 3 clinical~     published by Stupp et al in 2005 showed a benefit for using radiotherapy plus concomitant~     and adjuvant Temozolomide. Still, all patients experience a recurrence after first-line~     therapy, so improvements in both first-line and salvage therapy are critical to enhancing~     quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV)~     therapies even cross the blood brain barrier (BBB). Superselective Intra-arterial Cerebral~     Infusion (SIACI) is a technique that can effectively increase the concentration of drug~     delivered to the brain while sparing the body of systemic side effects. One currently used~     drug called Temozolomide (Temodar) has been shown to be active in human brain tumors but its~     actual CNS penetration is unknown. This phase I clinical research trial will test the~     hypothesis that following the standard 42 day Temozolomide/radiotherapy regimen,~     Temozolomide can be safely used by direct intracranial superselective intra-arterial~     cerebral infusion (SIACI) up to a dose of 250mg/m2, followed by the standard maintenance~     cycle of temozolomide to ultimately enhance survival of patients with newly diagnosed~     GBM/AA. The investigators will determine the toxicity profile and maximum tolerated dose~     (MTD) of SIACI Temozolomide. The investigators expect that this project will provide~     important information regarding the utility of SIACI Temozolomide therapy for malignant~     gliomas, and may alter the way these drugs are delivered to our patients in the near future.~   "
143158|NCT01180803|"~     The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems~     using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using~     oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing~     exercise-induced hypoxemia in patients with COPD.~   "
143159|NCT01180790|"~     Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of~     Care in HCV positive subjects.~   "
143160|NCT01180777|"~     The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of~     the printed etafilcon A with polyvinylpyrrolidone (PVP).~   "
143161|NCT01180764|"~     Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the good~     cholesterol) work better.~      Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL~     and other lipoproteins, in patients with high triglyceride levels.~      Study funding: This study is being funded by an investigator-initiated research grant from~     Glaxo Smith Kline.~   "
143162|NCT01180751|"~     This clinical trial is being conducted to study the use of a radioactive glucose tracer as~     an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected~     of having cancer and in another group of adults to assess for neurologic conditions.~   "
143163|NCT01180738|"~     The purpose of this study is to compare two different walking training programs for persons~     with chronic stroke.~   "
143164|NCT01180725|"~     Background: Constipation is a common problem that affects nearly 60 million Americans. The~     treatment of constipation remains challenging with one half of patients dissatisfied with~     current therapy. There is a need for a food-based, natural, convenient and tasty alternative~     to the currently available OTC laxatives and fiber supplements, particularly for patients~     with occasional and mild constipation. Dried plums and prune juice have been traditionally~     used for the treatment of constipation but has not been systematically assessed in patients~     with well defined constipation. Also, the efficacy, palatability and tolerability of dried~     plums in the treatment of chronic constipation have not been examined.~      Aim: To investigate and compare the effects of dried plums and psyllium on the overall~     relief of constipation symptoms, taste and quality of life in adults with functional~     constipation in a randomized crossover controlled trial.~      Methods: We propose to study 40 subjects with functional constipation in a single blinded,~     randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with~     Psyllium~      Data analysis: The primary outcome measure will be the global relief of constipation~     symptoms as rated by the subject at the end of each phase of the study. Additionally, we~     will assess several secondary outcome measures that will include the number of Complete~     Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile,~     patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and~     fullness and patient rating of constipation-related symptoms.~      Expected Results: We anticipate that treatment with dried plums will improve symptoms of~     constipation compared to the baseline. This improvement will be comparable to that achieved~     with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food~     based, convenient and more tasty alternative to over-the-counter laxatives and fiber~     supplements.~   "
143186|NCT01180439|"~     Non-invasive ventilation (NIV) in severe hypercapnic Chronic Obstructive Pulmonary Diseases~     (COPD) may be associated - during sleep - with recurrent episodes of patient ventilatory~     asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort~     of nocturnal NIV.Polysomnography (PSG) under NIV is necessary to detect these events.~      Adjusting ventilator settings according to respiratory events detected by PSG with NIV may~     improve quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.~   "
143187|NCT01180426|"~     The purpose of this study is to evaluate the long-term efficacy and safety profile of~     tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.~   "
143165|NCT01180712|"~     Dietary strategies for alleviating the metabolic complications such as diabetes associated~     with obesity are actively being pursued as alternatives to pharmaceutical interventions The~     genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a~     source of folk remedies for established diabetic symptoms, primarily as leaf or stem~     infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB)~     are enriched in anthocyanins, polyphenolics recognized for their ability to provide and~     activate cellular antioxidant protection, inhibit inflammatory gene expression, and~     consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity.~     The association of obesity with adipose tissue stress, macrophage recruitment, and~     inflammatory gene expression suggests that eating edible berries from this genus might~     provide an effective alternative or supplementary intervention to attenuate obesity-~     associated inflammation and the associated insulin resistance.~      The aim of this study is to determine the effects of anthocyanin supplementation in the form~     of a concentrated blaeberry extract on insulin resistance and inflammation particularly in~     the adipose tissue following a three week supplementation period.~   "
143166|NCT01180699|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia and contribute to the development of rejection. Although~     the annual influenza vaccine is recommended for transplant patients, studies have shown that~     a single intramuscular dose has poor immunogenicity. There are no studies that define the~     effect of intradermal doses in this population. We plan to study the immunogenicity of two~     different administration routes of the influenza vaccine in 200 solid organ transplant~     patients during the 2010-2011 season. Patients will be randomized to receive influenza~     vaccine either intradermally or intramuscularly. We hypothesize that the patients who~     receive the intradermal influenza vaccine will significantly reach a higher response to the~     vaccine. This study advances research on the prevention of serious viral infections in~     transplant recipients. Results from this study have the potential to directly improve~     patient care. If the use of the intradermal influenza vaccine is successful, this strategy~     may lead to a significant reduction in burden of disease, hospitalizations, and long-term~     morbidity.~   "
143167|NCT01180686|"~     The purposes of this study are to determine if there is a difference between two treatment~     methods of spine joints that are not moving as they should as determined by tenderness over~     the spine and activity of the muscles along side the spine with movement.~      The hypothesis is that there will be no difference between the two types of treatment.~   "
143168|NCT01180673|"~     This study will evaluate the effect of a senior center-based comprehensive therapeutic~     lifestyle intervention delivered through group-based counseling and motivational~     interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and~     older in a randomized control trial.~   "
143169|NCT01180660|"~     Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve~     quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use~     of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve~     quality of recovery after laparoscopic gastric bypass surgery.~      This study has the potential to confirm an opioid sparing strategy for morbid obese patients~     undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep~     apnea and the increased risk of postoperative hypoxemia make the development of opioid~     sparing techniques in this patient population warranted.~   "
143170|NCT01180647|"~     This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as~     self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release~     from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.~   "
143171|NCT01180634|"~     Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory~     tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa,~     which has been particularly problematic to eradicate and been implicated as the major cause~     of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the~     lung increases the local concentrations of antibiotic at the site of infection resulting in~     improved antimicrobial effects compared to systemic administration. Decreased efficacy,~     intolerance and high treatment burden with currently available therapies indicate a need for~     additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone~     levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies~     conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an~     antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal~     antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active~     against CF pathogens including those with high minimum inhibitory concentration (MIC) levels~     to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents.~     Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI~     investigational configuration of the eFlow® nebulizer system.~   "
143172|NCT01180621|"~     The seasonal influenza vaccination program for 2010-2011 will be the first to follow the~     H1N1 pandemic of 2009. Many children either had the H1N1 infection or the adjuvanted H1N1~     vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which~     could last for some time.~      The seasonal influenza vaccine for this fall will be a trivalent inactivated product~     (regular seasonal influenza vaccine)once again, without adjuvant. It will contain 3 strains~     of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic~     strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to~     people who still have some immunity to H1N1 virus could result in more frequent~     side-effects. However, there is no good evidence that pre-existing immunity to a strain in~     the vaccine does increase side-effects. In short, there could be nothing out of the ordinary~     this fall but it would be prudent to check this before public flu vaccination programs~     begin.~   "
143173|NCT01180608|"~     Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain~     in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):~      The aim of our study is to investigate the effect of Pregabalin as a treatment for~     neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on~     four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and~     dominant dorsolateral prefrontal cortex (DLPC).~   "
143174|NCT01180595|"~     Total knee replacement is an effective option for treating chronic knee conditions that~     cause pain and functional impairment. Significant improvements in quality of life, as~     measured by both disease specific and generic quality of life measures have been well~     documented. Carefully monitored introduction of new implant designs through small,~     randomized trials using radiostereometric analysis (RSA) is gaining support. RSA is a~     radiographic technique that uses small tantalum balls implanted into the patient's bone to~     measure micromotion (<1 mm) at the bone - implant interface, something which is not possible~     to do reliably using regular x-ray techniques. The amount of micromotion that occurs within~     2 years of surgery can be used to predict the long term survival of knee replacements. This~     provides a method for detecting inferior implant designs using only a small number of~     patients before release of these products into large clinical trials.~      The study purpose is to utilize RSA to compare the migration patterns of the Trabecular~     Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop~     years and to determine what proportion of cases achieve adequate fixation. Secondary outcome~     measures will be recorded to quantify changes in functional status of subjects after surgery~     and bone mineral density will be monitored to quantify any changes around the implant.~     Migration patterns will be compared to results obtained from previous studies of uncemented~     and cemented total knee arthroplasty components conducted at this centre.~      Null Hypothesis: There is no significant difference in micromotion patterns of the TM~     arthroplasty components of the monoblock design and the modular design.~      Alternative Hypothesis: There are significant differences in micromotion patterns between~     the tibial components of the monoblock design and the modular design.~      This is a consecutive sample randomized control trial of patients undergoing total knee~     arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to~     identify the migration patterns of the tibial components of the implant. DEXA scanning will~     also be conducted to determine changes in the bone mineral density adjacent to the implant.~     Health status and functional outcome measures will be recorded to quantify functional status~     of subjects before surgery and at each follow-up interval. Gait will be monitored and~     analyzed preoperatively and postoperatively throughout the duration of the trial.~   "
143175|NCT01180582|"~     The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of~     the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years~     postoperatively and thus determine the proportion of cases where adequate fixation is~     achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density~     changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two~     postoperative years.~      In addition, gait assessment and validated outcome questionnaires will be utilized to~     quantify changes in functional status of subjects after surgery and migration patterns will~     be compared to results obtained from previous studies of uncemented total knee arthroplasty~     components conducted at this centre. Questions to be asked are: 1. Do the components achieve~     adequate fixation to the underlying bone? 2. What are the migration patterns (translations~     and rotations) of the PA coated arthroplasty components during the first two years~     postoperatively and are they different from that seen for other implants that have been~     studied with RSA at this institution? 3. For what proportion of implants does migration~     continue to increase during the two year follow-up? 4. Are inducible displacements, measured~     at weight-bearing follow-ups, consistent over time and do they indicate that adequate~     fixation has been achieved? 5. Are there changes over time in bone mineral density of~     peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes~     in bone mineral density occur? 7: Is there a significant difference in health status and~     functional outcome before and after total knee arthroplasty using PA coated Triathlon total~     knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM)~     displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively~     and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are~     there differences in the micromotion patterns between the when compared to other samples of~     knee implants in our RSA database?~   "
143176|NCT01180569|"~     The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given~     by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the~     lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration~     (FDA). It is used to treat some forms of cancer-like illnesses (myelodysplastic syndrome~     (MDS)and in combination with dexamethasone for patients with multiple myeloma (MM) who have~     received at least 1 prior therapy. MDS and MM are cancers of the blood). This drug works by~     stimulating the body's immune system and by reducing the blood supply to cancer cells.~     Cancer cells need blood to live and grow. In this study, the drug is considered a new or~     experimental drug because we are learning how it works against your form of lymphoma.~   "
143177|NCT01180556|"~     The purpose of this study is to assess the effect of probiotics in childhood recurrent~     abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4~     weeks with a follow up phase of additional 4 weeks.~   "
143178|NCT01180543|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
143179|NCT01180530|"~     This study is conducted in Asia, Europe and North America. The aim of this observational~     study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence~     of technical complaints related to adverse reactions). Study duration: 12-18 weeks.~   "
143180|NCT01180517|"~     The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon~     (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention~     (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment~     with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.~   "
143181|NCT01180504|"~     The primary objective of this phase-II study is to assess the toxicity of consolidation~     intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced~     optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III~     ovarian cancer with a complete remission after adjuvant chemotherapy.~      36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning~     target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node~     regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of~     liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).~   "
143182|NCT01180491|"~     The purpose of this study is to further evaluate and document early visible effects on nail~     appearance of topical K101.~   "
143183|NCT01180478|"~     The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band~     Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients~     with non-muscle invasive bladder cancer.~   "
143184|NCT01180465|"~     LIPO-102 is under evaluation for treatment of abdominal adiposity~   "
143185|NCT01180452|"~     Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma~     (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with~     SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and~     natural history remains unknown but progression of inflammation to dysplasia and then to~     adenocarcinoma is suspected.~      As for surveillance recommendations for colorectal carcinoma in long standing inflammatory~     colonic disease, endoscopic screening of SB could be proposed in CD patients with risk~     factors of SBA. No study can be found in literature.~      The investigators propose a multicenter exploratory open study on prospective cohort of CD~     patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia~     and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population~   "
143188|NCT01180413|"~     The purpose of this study is to determine whether add-on of intensive vasodilator therapy~     can improve the coronary perfusion and reduce the total peripheral resistance in patients~     with ongoing treatment for essential hypertension.~   "
143190|NCT01180387|"~     The Reproductive Medicine Network (RMN) is a nationwide cooperative network of 7 clinical~     sites and a data coordination center, and is sponsored in 5 year increments by The Eunice~     Kennedy Shriver National Institute for Child Health and Human Development (NICHD). The RMN~     is charged with designing, implementing and publishing high quality clinical research in~     reproductive medicine. It has been in existence for over 15 years and has performed several~     seminal clinical trials that have fundamentally changed clinical practice in this field. In~     addition, many worthy ancillary protocols have been generated and published.~      It is this latter fact, as well as the continued interest by investigators both inside and~     outside the RMN for access to DNA or serum samples from the previously performed trials,~     that has motivated the present investigators to proactively begin a biologic samples~     repository from the ongoing and pending RMN clinical trials. Ideally, this repository would~     allow investigators to seamlessly access trial samples for many years into the future, and~     thus greatly amplify the use of resources and the impact of the RMN.~   "
143191|NCT01180374|"~     Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists~     of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the~     interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.~   "
143192|NCT01180361|"~     Hypothesis: SLE and RA increase risk of myocardial infarction (MI, heart attack). Immune~     reactants in the circulation of SLE patients downregulate cholesterol efflux proteins~     27-hydroxylase and ABCA1 and upregulate scavenger receptor CD36, thus encouraging~     cholesterol accumulation. Adenosine A2A receptor agonist or statin treatment of cells~     exposed to SLE plasma (or immune complexes or cytokine-enriched plasma fractions from SLE~     patients) may ameliorate inflammatory properties of their plasma, lessening its atherogenic~     potency.~      Rationale: SLE and RA plasma contain components not present in significant levels in normal~     plasma that could, individually or acting together, affect 27-hydroxylase, ABCA1 and CD36~     expression. Candidate components include autoantibodies, immune complexes, and various~     cytokines. Statins reduce major cardiovascular events and death. Modulation of adenosine~     signaling participates in regulation of 27-hydroxylase and ABCA1. As a potential~     preventative and therapeutic approach to atherosclerotic cardiovascular disease, the~     investigators evaluate the effect of A2A receptor agonists and statins on atherogenic~     parameters in SLE and RA plasma.~      Experimental Plan: Quantitate 27-hydroxylase and several other proteins involved in cellular~     cholesterol uptake and excretion in THP-1 monocytes/macrophages and HAEC after exposure to~     plasma and plasma components from SLE patients (and controls) ± lipid loading with~     acetylated LDL with/without addition of A2AR agonist, statin, or both. Determine relative~     impact of immune complexes and cytokines on expression of proteins involved in cholesterol~     flux. Determine levels of proteins involved in cellular cholesterol influx/efflux in~     peripheral blood mononuclear cells isolated from RA, SLE and psoriatic arthritis patients~     and normal controls at baseline, then following incubation in culture media alone or with~     statin, adenosine A2A agonist or both statin + A2AR agonist.~   "
143193|NCT01180348|"~     The dermatological treatment for reducing facial wrinkles with injectable drug Botulift~     (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior~     activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.~   "
143194|NCT01180335|"~     This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven~     chemotherapy in patients with breast cancer.~   "
143195|NCT01180322|"~     This is a randomized phase II, four-arm, open-label, multi-center study in adult patients~     with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria.~      The primary efficacy objective is to evaluate the impact of sequential or concurrent~     addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide~     on the complete remission (CR) rate~      Sample size: 336 patients~      The treatment duration of an individual patient randomized into one of the three~     experimental arms (Arm B, C, D) (in case of application of induction, consolidation and~     maintenance therapy with Azacitidine) is about 30 months.~      The treatment duration for patients randomized into the standard arm of the study (Arm A) is~     about 7 months (in case of application of induction, consolidation and 2-yrs observation as~     maintenance (without treatment with Azacitidine)).~      In case of induction followed by consolidation with allogeneic Stem cell transplantation~     (SCT) the treatment duration per patient is about 6 months.~      Every patient will be followed until month 54 after inclusion into the study. Duration of~     the study for an individual patient including treatment (induction, consolidation~     [chemotherapy or allogeneic SCT], maintenance [experimental arm with Azacitidine or~     observation]) and follow-up period: 54 months~   "
143196|NCT01180309|"~     Purpose To investigate the relationship between lingual frenum and possible alterations in~     the articulation of phonemes.~      Methods This is a quantitative observational study, the individual operative kind with~     transversal time reference. The population sample consisted of 16 individuals, each one with~     their phonological system complete. The data were captured through an application form that~     contained relevant aspects as to the qualitative-classification of the lingual frenum,~     quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue~     mobility and ERT - 78 phonologically balanced words.~   "
143197|NCT01180296|"~     To evaluate whether daily oral micronized progesterone is effective in preventing recurrent~     spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal~     serum progesterone levels.~   "
143198|NCT01180283|"~     Sixty diabetes men with erectile dysfunction from mild to severe who agree to participate is~     going to have medical care approximately for 16 weeks.~      During the first 4 weeks, patients will not receive any inhibitor of phosphodiesterase 5. In~     the following eight weeks, patients will receive oral lodenafil carbonate. They will~     complete the International Index of Erectile Dysfunction (IIEF) questionnaire in the site~     and answer the Sexual Encounter Profile (SEP) questions 2 and 3 and the Erection Hadness~     Score (EHS) after each intercourse or attempt without or using oral lodenafil cardonate~     80mg.~      Questionnaire of adverse event is included in patient diary.~   "
143199|NCT01180270|"~     The purpose of this experimental pilot study is to test the effect of normalization of the~     head position on the sense of balance at patients with cervical dystonia under routine~     botulinum toxin treatment.~   "
143200|NCT01180244|"~     The purpose of this study is to determine whether persons treated with a low-intensity,~     noninvasive form of cortical electrical stimulation experience a reduction in symptoms of~     fibromyalgia different than persons receiving a sham treatment. Outcome measures include~     reduction in patient pain levels and improvement in sleep measures.~   "
143212|NCT01180088|"~     The aim of this study was to evaluated the advantages of routine application of the anterior~     approach in patients scheduled to right hepatectomy or extended right hepatectomy, without~     infiltration of segment 1, inferior vena cava or main bile duct.~   "
147725|NCT01120769|"~     The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid~     peroxidation and isoprostane formation during reperfusion after percutaneous~     revascularization for acute myocardial infarction.~   "
143201|NCT01180231|"~     The prevalence of obesity is increasing rapidly among adults and has more than doubled in~     the past 10 years. The metabolic syndrome (MS) is often associated with obesity. It is~     characterized by abdominal obesity, high blood pressure, unfavorable blood cholesterol~     profile, elevated blood sugar and impaired insulin action. Persons with the MS have an~     increased risk of developing type 2 diabetes as well as heart and kidney disease.~      The prevalence of obesity and MS is also very high in children and young adults. While there~     are increasing numbers of studies assessing risk factors for cardiovascular and kidney~     disease in middle aged to older obese subjects, few studies have addressed the issue of the~     presence of obesity in young adults and its association with MS on early damage to the~     organs such as the kidneys, the heart and the blood vessels. The investigators' laboratory~     has a particular interest on the sympathetic nervous system, which is an important~     regulatory mechanism of both metabolic and cardiovascular function, as altered sympathetic~     activity may play a role in the complications of obesity.~      Moxonidine is a medication that is approved in Australia by the Therapeutic Goods~     Administration to treat high blood pressure. It works by decreasing the activity of the~     sympathetic nervous system. With the elevation of the sympathetic activity in obesity, the~     investigators believe moxonidine may have a favourable role in rescuing early organ damage~     associated with obesity. This study will assess whether treating obese subjects with~     moxonidine have positive effects on blood vessels, cardiac and kidney function and anxiety~     disorder. The investigators will also examine the influence of the sympathetic nervous~     system activity in these possible altered cardiac, kidney and vessel functions.~   "
143202|NCT01180218|"~     To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with~     multivessel disease undergoing percutaneous coronary intervention (PCI) either in~     infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the~     everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical~     practice.~   "
143203|NCT01180205|"~     To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs~     Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by~     flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal~     BP in both arms; target BP <140/90 mmHg (<130/80 mmHg for renally impaired and/ or diabetic~     patients). To investigate the effects of T and A vs O and HCTZ in reducing arterial~     stiffness and carotid atherosclerotic plaques.~   "
143204|NCT01180192|"~     In the aetiology of postpartum uterine atony, hypoxia is considered an important factor~     although some suggest that peripheral oxygen saturation is not influenced by oxygen~     inhalation in women during the first and second stages of labor. Enhancing oxygen delivery~     to myometrium through additional inhaled oxygen may improve uterine contractions. Therefore,~     it is reasonable to consider that oxygen inhalation may promote myometrial contraction and~     prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to~     relax in women encountering respiratory problems immediately after cesarean section under~     general anaesthesia further strengthened this theory.~      The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately~     after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen~     helps to maintain uterine retraction during immediate postpartum period and hence reduces~     vaginal blood loss.~   "
143205|NCT01180179|"~     The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole)~     and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in~     patients with a history of H. pylori-negative idiopathic peptic ulcers.~   "
143206|NCT01180166|"~     The prognosis of patients with inoperable locally advanced or residual/relapsed gastric~     cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended.~     Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown~     its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of~     these treatment need to be further analyzed.~   "
143207|NCT01180153|"~     To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with~     unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.~   "
143208|NCT01180140|"~     The purpose of this study is to determinate the utility of staple-line reinforcement on~     lineal gastrointestinal anastomoses.~      Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive~     lineal stapled anastomoses.~   "
143209|NCT01180127|"~     This is a randomized controlled trial to test the impact of a flavonol containing food~     product and aerobic exercise on cognitive function and brain structure.~   "
143210|NCT01180114|"~     The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family~     economic empowerment intervention that creates economic opportunities (specifically Children~     Development Accounts) for families in Uganda who are caring for children orphaned due to the~     AIDS pandemic, and to lay groundwork for a bigger study with practice and policy~     implications for Sub-Saharan Africa.~   "
143211|NCT01180101|"~     Obesity is an established risk factor for development and progression of kidney disease.~     Intentional weight loss in people without kidney disease results in an improvement in~     diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The~     investigators do not know whether this holds true in patients with chronic kidney disease.~     In the proposed pilot study, the investigators will analyze if kidney function stabilizes~     after weight loss interventions in obese kidney disease patients and the mechanisms that~     might mediate this beneficial effect. If weight loss in kidney disease patients results in~     stabilization of kidney function, this would provide an opportunity to conduct a long-term~     prospective study to analyze the sustained benefits of weight loss in kidney disease~     patients.~      Specific aim 1:~      To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein~     excretion and renal function among obese CKD patients.~      Hypothesis: Weight loss attained through either lifestyle modification or surgical~     intervention will result in lowering of urinary protein excretion and stabilization of renal~     function among obese CKD patients.~      Specific aim 2:~      To identify the mechanism that mediates the change in urinary protein excretion and renal~     function among obese CKD patients undergoing lifestyle modification or bariatric surgery.~      Hypothesis: Weight loss attained through either lifestyle modification or surgical~     intervention will result in amelioration of endothelial dysfunction, inflammation, insulin~     resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then~     mediate the improvement in urinary protein excretion and renal function among obese CKD~     patients.~   "
143213|NCT01180075|"~     Purpose: To see how growing older changes the amount of HIV drugs in the blood of~     HIV-infected men and women. Many changes happen in the body as it ages that may affect the~     way drugs are carried in the blood, broken down or removed from the body. This study will~     look at the amount of drug in the blood and cells of the immune system for patients taking~     efavirenz, tenofovir and emtricitabine or atazanavir boosted with ritonavir, tenofovir and~     emtricitabine.~      Participants: The population will comprise of 56 (6 for intensive PK and 50 for sparse~     sampling) HIV-infected adults currently adhering to an antiretroviral regimen containing~     efavirenz with tenofovir and emtricitabine and the same number and distribution of~     HIV-infected adults currently adhering to an antiretroviral regimen containing atazanavir~     boosted with ritonavir with tenofovir and emtricitabine.~      Procedures (methods): This study will be completed at the University of North Carolina at~     Chapel Hill. There will be four groups of subjects: Efavirenz/tenofovir/emtricitabine Group~     A, Efavirenz/tenofovir/emtricitabine Group B, Atazanavir/ritonavir/tenofovir/emtricitabine~     Group A, and Atazanavir/ritonavir/tenofovir/emtricitabine Group B.~      The initial six subjects (Group A) for intensive PK analysis for each regimen will be~     recruited from the the UNC ID Clinic or the Moses Cone Health System Infectious Diseases~     Clinic, and will be comprised of non-frail subjects not currently receiving interacting~     drugs. If subjects provide informed consent, timed blood samples will be obtained to~     determine pharmacokinetic parameters around an observed dose of one of the two study~     regimens. A whole blood sample will also be collected and stored for potential drug~     metabolizing enzymes and transporters genotyping in the future. Group A subjects will~     complete a follow-up visit after their sampling visit.~      50 subsequent subjects (Group B) for each regimen will be screened simultaneously, with no~     more than 10 subjects enrolled for each regimen in Group B prior to the completion and~     analysis of Group A. These subjects will also be recruited from either site. Group B~     subjects will have one or two sampling visits with 1 to 4 blood samples obtained at each~     visit, with a stored sample for future genotyping obtained on one of the visits. Samples~     will be collected just prior to a dose, at 2 hours, between 4 and 6 hrs, and between 10 and~     14 hours after a medication dose. These visits may coincide with the subjects' regularly~     scheduled visit to the clinic, or be scheduled separately, depending on the preference and~     availability of the subject.~   "
143214|NCT01180062|"~     This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which~     will be conducted at one study site. This study will include 3 cohorts. Each cohort will~     have approximately 5 subjects. Subjects will not be randomized into the study. The first~     cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts~     thus achieving twice the drug levels compared to cohort I and third cohort will receive high~     dose drug insert.~   "
143215|NCT01180049|"~     This study will compare the effectiveness and safety of two different doses of temsirolimus~     (Torisel).~   "
143216|NCT01180036|"~     The primary outcome of this study is to determine whether or not the B cell targeting with~     Rituximab is more effective than Cyclosporine in inducing long term remission of~     proteinuria.~   "
143217|NCT01180023|"~     Sweeping or stripping of the membranes (in this paper referred to as membrane sweeping) is~     a widely utilized technique to hasten delivery for women at 37+ weeks gestation. The process~     of membrane sweeping probably causes release of prostaglandins from the decidua and the~     cervix. The efficacy of membrane sweeping is well studied, and has been shown to increase~     the number of patients in labor within 72 hours, reduce the frequency of pregnancy~     continuing beyond 41 or 42 weeks, and reduce the frequency of formal induction of labor.~     Thus, it is a safe and practical option for women who wish to avoid inductions of labor or~     postterm pregnancies.~      Group B streptococcus (GBS; streptococcus agalactiae) is a gram positive coccus that~     frequently colonizes the human genital tract. In pregnant women, GBS can cause urinary tract~     infections, chorioamnionitis, and postpartum endometritis. Newborn infants can also acquire~     GBS infection during passage through the vagina. Early onset GBS disease in the newborn can~     lead to pneumonia, meningitis, and sepsis, all of which can be life-threatening. Early onset~     GBS disease has become rare since the widespread use of GBS screening and prophylactic~     treatment of pregnant women.~      The relationship between early onset GBS disease and sweeping of the membranes is not known.~     Based on the theoretical increased risk of bacterial seeding after membrane sweeping, as~     well as concern for fast labors and inadequate treatment after membrane sweeping, some~     practitioners choose not to sweep membranes in GBS positive patients. A meta-analysis did~     not show a difference in neonatal or maternal infection rates between women who underwent~     membrane sweeping and those who did not. ACOG guidelines state the risks of membrane~     stripping in GBS positive patients has not been investigated in well-designed, prospective~     studies. Therefore, data are insufficient to encourage or discourage this practice.~      Specific Aims:~      In order to help elucidate the effect of membrane sweeping in GBS positive patients, the~     investigators propose this prospective randomized trial. The investigators primary objective~     is to determine whether membrane sweeping in GBS positive women is associated with~     inadequate antibiotic treatment in labor (defined as less than four hours of antibiotic~     therapy prior to delivery). The investigators secondary objectives are to measure the effect~     of membrane sweeping on pregnancy duration, length of labor and adverse events potentially~     related to membrane sweeping such as maternal chorioamnionitis and neonatal morbidity.~     Randomization is the real research portion of this study, since offering membrane sweeping~     is already the standard of care. Patients are followed until the time of delivery, which is~     within 6 weeks of enrollment for most women.~   "
143218|NCT01180010|"~     This research study is being done because patients with a history of chest radiation~     treatment for Hodgkin's disease have been shown to be at increased risk for developing lung~     cancer a number of years out from treatment. The risk appears to be further increased among~     patients with a smoking history. In this study, the CT scans will be read and interpreted by~     the study radiologist, and the results recorded in a consistent manner. Depending on the~     findings of the initial CT scan, we will then either repeat the scan in 1 year, or if~     indicated, send you for further scans or a biopsy. The information collected in this study~     will help researchers and clinicians in providing more concrete recommendations and~     screening guidelines for future survivors of Hodgkin's disease who have had similar~     exposures to radiation and/or chemotherapy and smoking.~   "
143219|NCT01179997|"~     The aim of this study was to compare the response to cardiac resynchronization therapy when~     the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to~     response when it was optimized following QRS width criteria.~   "
143220|NCT01179984|"~     The purpose of this study is to evaluate the effectiveness and safety of a new delivery~     system for the Bard® LifeStent® Vascular Stent System.~   "
143221|NCT01179971|"~     Purpose: To investigate into the differential effects of polyunsaturated fatty acids as~     compared to standard control therapy (olive oil) on disease activity and biochemical~     parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).~   "
143222|NCT01179958|"~     The purpose of this study is to test the hypothesis that aerobic exercise leads improved~     cognitive function accompanied by increases in gray matter density and changes in functional~     magnetic resonance imaging (fMRI) patterns of task-related activation.~   "
143223|NCT01179945|"~     The investigators propose to examine the effects of the common food preservative sodium~     benzoate on blood glucose and related hormones and metabolites. If an effect is~     demonstrated, patients with increased diabetes risk could be counseled to avoid this~     preservative.~   "
143224|NCT01179932|"~     Primary Objective: Conduct a prospective, observational pilot study that assesses the~     frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical~     environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and~     electrophysiology laboratory) as assessed by a customized error scoring system that focuses~     on the magnitude of errors among multiple continuous, categorical and dichotomous variables.~     The errors are being assessed in order to identify the most common charting inaccuracies so~     that target areas appropriate for testing of improvement strategies may be isolated.~   "
143249|NCT01179607|"~     M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor~     inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic~     effect of M0002 has a potential clinical benefit in the treatment of ascites and~     hyponatreamia in cirrhotic patients.~   "
143225|NCT01179919|"~     One in three Americans are obese. Obese subjects may or may not need higher doses of the~     anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the~     FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy~     volunteers compared to that previously shown in non-obese volunteers.~   "
143226|NCT01179906|"~     Aerobic training has been shown to favorably alter several of the known risk factors for~     coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It~     seems logical that if these risk factors were aggressively controlled in patients with~     chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise~     training) to support the pharmacologic interventions that are necessary for the control of~     the disease, then the rate of progression of the disease may be altered. However, to date,~     there is no clear research evidence to support this hypothesis. Therefore the aims of the~     proposed study are:~        1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and~          regular, long-term aerobic exercise training) will favorably alter the natural~          progression of CKD in a sample of patients compared to a control group who will receive~          the current standard care.~        2. To explore possible mechanisms that could contribute to the observed changes.~   "
143227|NCT01179893|"~     Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior~     studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous~     immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine~     if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.~      Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with~     a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be~     evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to~     IVIG.~   "
143228|NCT01179880|"~     The safety and pharmacokinetics of topical application with E6005 ointment compared to~     vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally,~     the efficacy of topical application with E6005 ointment will be explored in Japanese male~     patients with atopic dermatitis.~   "
143229|NCT01179867|"~     The purpose of this study is to determine if a physician's use of electronic medication~     reconciliation software when writing a patient's discharge prescription will prevent adverse~     drug events and readmissions to the hospital. This electronic medication software will~     provide the physician with the most up-to-date list of medications the patient was taking~     before being admitted to the hospital, through a real-time link to the provincial drug~     insurance agency's administrative databases. It will also provide the list of medications~     the patient has taken while admitted to the hospital. With these two pieces of information,~     the physician will write the discharge prescription using the medication management~     software, print the discharge prescription for the patient, and the software will fax a copy~     of any prescriptions that should be stopped to the patient's community pharmacist.~   "
143230|NCT01179854|"~     The purpose of this study is to determine weather different doses of Remegal are~     effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial~     Seizures and pharmacokinetics definition~   "
143231|NCT01179841|"~     This research is being done to test the effectiveness of an early intervention model for~     very young children at high risk for autism spectrum disorders (ASD) and their families. If~     children show improvement in this intervention, the investigators hope that the availability~     of public services of this type will be increased. Children between 11 months and 21 months~     old with Autism Spectrum Disorders, or with social and communication delays that indicate~     high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment~     must start prior to the second birthday.~   "
143232|NCT01179828|"~     Drug therapy in patients with chronic low back pain is a major challenge for physicians. One~     of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient.~     Usually one of the classes of pain medication is given to patients with a similar clinical~     picture, although different pain mechanisms may be responsible for this clinical picture.~      Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason~     why an unique drug produces different responses (from a lacking analgesic effect up to~     excessive effect or side-effects.~      Quantitative sensory testing is a method that documents alterations in the pain perception~     system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for~     anticipation of drug efficacy.~   "
143233|NCT01179815|"~     Currently, the estimated number of people with diabetes mellitus is around 250 million. Due~     to population growth, urbanization, ageing and the rising prevalence of obesity the numbers~     of individuals with diabetes is increasing likewise. It has been shown that improving~     glycemic control is associated with a reduction in late complications of diabetes, such as~     cardiovascular and microvascular diseases. Therefore, treatment guidelines were established~     internationally by large and renowned associations and adopted by many countries.~      For Switzerland only sparse data exist on the actual implementation of such recommendations~     and on patient's well-being. The SwissDiab Pilot Study is a prospective cohort study aiming~     at the collection of data on diabetic patients (type 1 and type 2) at two tertiary hospitals~     in Switzerland. This allows the evaluation of diabetes treatment strategies at these~     centers. Furthermore, risk indicators for micro- and macrovascular complications, mortality~     as well as costs and quality of life will be assessed. Data will be recorded through an~     internet-based, electronic database specifically designed for this study. At a later~     perspective it is planned to extend data collection to general practitioner/family doctor~     networks in order to include a larger and more representative sample of diabetic patients in~     Switzerland.~   "
143250|NCT01179594|"~     This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety~     of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in~     patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to~     receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or~     entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg~     subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during~     weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48~     weeks. Target sample size is <500 patients.~   "
143234|NCT01179802|"~     Until now it has been assumed that regular endurance training has a positive influence on~     cardiac function and that the positive effect increases with increasing intensity. However,~     little is known about the effects of intense endurance stress on the heart. According to~     current knowledge repeated exposure to strenuous endurance activity may lead to minor but~     possibly irreversible damage to the heart with resultant scarring of the heart's muscle.~      Within this study we attempt to find out by different analytical methods - in particular~     magnetic resonance imaging (MRI) and ultrasound of the heart - to what extent the heart~     muscle is affected by an intense endurance exercise, i.e. the Jungfrau-Marathon, and which~     changes can possibly be found. Due to repeated measurements we will obtain further~     information on the short-term course of possible changes.~      Hypotheses: A single bout of prolonged strenuous exercise (PSE) leads to transient~     alteration in cardiac function accompanied by the appearance of biomarkers for myocardial~     damage.~   "
143235|NCT01179789|"~     Ageing of the population is a major event in the world. Gerontological/geriatric literature~     unanimously indicate that physical exercise and diet are at present the two available~     fundamental approaches to contrast/prevent most of the age associated alterations. In the~     elderly the inflammageing, the oxidative stress and the alteration of the intestinal~     microbiota can be influenced by nutritional status and possibly corrected by an appropriate~     dietetic intervention:~      Nowadays the nutraceutical food supplements become an opportunity for the consumer to~     improve the quality of individual diet for specific needs~   "
143236|NCT01179776|"~     Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary~     percutaneous cardiac intervention will following the standard treatment , received low dose~     of Ilomedin and to low dose of standard treatment for another 24 hours.~   "
143237|NCT01179763|"~     The purpose of this study is to examine retinal layer thickness in amblyopia.~   "
143238|NCT01179750|"~     Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once~     during operation. It was proved that a laparoscopic gastric resection showed significantly~     shorter operative time and less work load distribution, and more stability of bleeding than~     before an introduction of ultrasonic coagulating shears .~      In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for~     lymph node dissection or cutting of small vessels in some hospitals in Korea. However its~     usefulness or effectiveness has not been fully proved. There was only one report about using~     ultrasonic coagulating shears in open gastrectomy. The report contained small number of~     subjects and surgical procedures were different from the investigators.~      The investigators expect to reduce operative time and blood loss with ultrasonic coagulating~     shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure~     of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and~     shorten the removal time of a drain, which will also shorten the hospital stay.~      The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating~     shears in open gastrectomy including usefulness and effectiveness by a randomized~     controlled, prospective study.~   "
143239|NCT01179737|"~     The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in~     this population and to test the hypothesis that 6 months treatment with nilotinib will~     significantly reduce pulmonary artery resistance.~   "
143240|NCT01179724|"~     after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton~     pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing~     bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger~     acid suppression (high dose PPI) more effectively prevents bleeding after ESD~   "
143241|NCT01179711|"~     In most clinics, physicians reduce diopter of hyperopic glasses in older patients with~     accommodative esotropia. However, there are risks of decompensation in that practice. The~     authors are going to try measure the change of stability of eye alignment after reducing~     diopter of hyperopic glasses.~   "
143242|NCT01179698|"~     Bone tumor near the articular cartilage is hard to remove sufficiently without damaging~     adjacent joint. The purpose of this study was to evaluate the feasibility of~     navigation-assisted surgery for saving joint in bone tumor resection or curettage. In this~     study, the investigators hypothesized that computer-assisted surgery is feasible method to~     get both enough margin and joint salvage. Each of them is important intermediate factor for~     either oncologic outcome or functional outcome respectively. The investigators designed this~     study to find what proportion of patients who underwent computer-assisted resection could~     get enough margins using some criteria obtained by overlapping preoperative and~     postoperative images. The investigators also evaluated whether computer-assisted surgery can~     be feasible for joint saving using some criteria including functional outcome.~   "
143243|NCT01179685|"~     Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta.~     The purpose of this prospective study was to investigate the sensitivity, specificity and~     accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis~     of malignant pleural effusion.~   "
143244|NCT01179672|"~     The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once~     daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks~     as measured by the weekly mean of the daily pain scores recorded in the participant's diary~     in participants with diabetic peripheral neuropathic pain.~   "
143245|NCT01179659|"~     The objective of this study was to assess the single-dose bioequivalence of KUDCO's and~     Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed~     conditions.~   "
143246|NCT01179646|"~     The objective of this study was to determine the single-dose bioequivalence of the test~     product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared~     with the reference product, a pantoprazole 40 mg delayed-release tablet formulation~     (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.~   "
143247|NCT01179633|"~     The purpose of this study was to demonstrate the effect of short treatment with active OPLON~     patches on Acne.~   "
143248|NCT01179620|"~     This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to~     prevent clotting during hemodialysis.~   "
143802|NCT01172366|"~     The hypotheses for this study is that there is no transfer of testosterone from male (donor)~     subjects to female (recipient) subjects when contact is made 2 hours post application of 2%~     Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.~   "
143251|NCT01179581|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending~     (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).~      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple~     oral administration will be evaluated, and, if applicable, the maximum tolerated dose~     determined.~   "
143252|NCT01179568|"~     The major goal of this 4-site, double blind, placebo-controlled intervention trial is to~     assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated~     Grief Therapy) to treat the symptoms of complicated grief.~   "
143253|NCT01179555|"~     Diabetic retinopathy is a common eye condition among diabetic adults and can lead to severe~     vision impairment and even blindness. African Americans are more likely to have vision loss~     from diabetic retinopathy due to a variety of factors, including cultural barriers to care.~     The investigators aim to increase the rates of eye exams in diabetic African American adults~     by providing culturally relevant home-based interventions. These interventions will increase~     the knowledge about diabetes and the eyes and the awareness of ocular risks due to diabetes.~      206 African American adults, over the age of 65, with diabetes will be recruited from~     primary care clinics at Thomas Jefferson and Temple University. Eligible patients who~     consent to participate will have baseline information taken about medical and ocular~     history, understanding of diabetes and a hemoglobin A1C level obtained. The subjects will~     then be randomized to one of two treatment conditions: Behavioral Activation or Supportive~     Therapy, each of which will be delivered over 4 sessions. Behavioral Activation will consist~     of educational materials, referral assistance for eye clinics, and addressing patient~     specific barriers to care. Supportive Therapy will consist of supportive but non-directional~     interaction with the patient exploring the impact of aging and diabetes on the patient's~     life. The investigators hypothesize that more patients who receive Behavioral Activation~     will have a dilated fundus exam (the primary outcome variable), understand the risks of~     diabetic complications and feel less depression then subjects who receive Supportive~     Therapy.~   "
143254|NCT01179542|"~     The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental~     implantation and in the pathological pregnancies: preeclampsia and IUGR.~   "
143255|NCT01179529|"~     This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis,~     and to work out biomarkers predictive of treatment response.~   "
143256|NCT01179516|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     vortioxetine, once daily (QD), compared with placebo in adults with major depressive~     disorder.~   "
143257|NCT01179503|"~     A growing body of evidence suggests that vitamin D status is important in biologic processes~     involved in the maintenance of physical function. To advance the investigators understanding~     of the role of vitamin D in physical function, the investigators will conduct a feasibility~     pilot study to collect key information to help design a full-scale randomized trial to~     determine whether vitamin D supplementation will delay declines in physical function. The~     primary goals of the pilot study are to determine cost-effective strategies for identifying~     persons at high risk for functional decline with insufficient vitamin D levels, determine~     the serum vitamin D response to a vitamin D supplementation regimen designed to attain~     sufficient vitamin D levels, and provide preliminary data of key functional measures~     (balance, physical performance and muscle power) for the future larger study design. A~     secondary goal is to begin to examine potential mechanisms by which vitamin D~     supplementation may enhance physical performance by exploring the effects of vitamin D~     supplementation on changes in skeletal muscle gene expression.~   "
143258|NCT01179490|"~     The study objectives of this study are to determine the effects, safety, and~     pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and~     prednisolone.~   "
143259|NCT01179477|"~     The purpose of this multicenter post-approval study is to evaluate the acute and chronic~     performance of the QuickFlex® μ 1258T left ventricular lead.~   "
143260|NCT01179464|"~     The purpose of this study is to investigate the effects of aminobiphosphonate treatment on~     the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether~     these effects are inhibited by simultaneous treatment with statins.~   "
143261|NCT01179451|"~     The purpose of this study is to determine whether there is late cardial involvement in~     children diagnosed with post streptococcal reactive arthritis after discontinuation of~     prophylactic antibiotic therapy.~   "
143262|NCT01179438|"~     Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave~     lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly~     selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid~     requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause~     pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or~     procedural stress may induce inflammation and it may cause further microthrombosis. Both~     vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of~     microcirculation may impair tissue perfusion and result in organ dysfunction.~     Dexmedetomidine may induce vasodilation by slow intravenous infusion for sedation.~     Dexmedetomidine may also reduce inflammation. After reviewing the literature, the~     investigators found that the effect of dexmedetomidine on microcirculation was not well~     investigated. By application of the non-invasive technique of sidestream dark field imaging,~     the investigators can investigate the vessel density, percentage of perfused vessels, and~     microvascular flow index on sublingual vessels.~      The goal of this study is to identify the effect of dexmedetomidine on sublingual~     microcirculation in patient undergoing extracorporeal shock wave lithotripsy.~   "
143263|NCT01179425|"~     The purpose of this study is to explore sex differences in cognitive functioning and~     responses to marijuana-related items, and to determine whether stress impacts these~     measures.~      Hypothesis 1: Attentional bias will be greater for marijuana cues in male~     marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male~     controls.~      Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in~     attentional bias and cognitive functioning than marijuana-dependent males.~   "
143264|NCT01179412|"~     The purpose of this study is to determine the outcomes of treating epidemic~     keratoconjunctivitis with 2% povidone-iodine.~   "
143803|NCT01172353|"~     The purpose of this study is to determine whether hydration with sodium bicarbonate is~     superior to hydration with saline to prevent contrast-induced nephropathy.~   "
143265|NCT01179399|"~     Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose,~     dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK),~     and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies.~     This study will be the first to administer TAK-960 to humans. The patient population will~     consist of adults with a nonhematologic malignancy for which standard treatment is no longer~     effective or does not offer curative or life-prolonging potential, or for which no standard~     treatment is available.~   "
143266|NCT01179386|"~     Adolescents suffering of ADHD may have impaired driving performance. The investigators would~     like to check the differences in driving performance in young adults(aged: 15-18 years) with~     ADHD by driving simulator and seat pressure mapping with and without methylphenidate~     medication.~   "
143267|NCT01179373|"~     The primary objective of this trial is to assess the ability of Transcranial Magnetic~     Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training,~     to improve cognitive performance in patients with Alzheimer's disease which received drug~     treatment. This study is a single-center, double-blind 4 months duration trial.~   "
143268|NCT01179360|"~     To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission~     tomography/computed tomography (PET/CT) is performant enough with respect to detecting~     residual lymph node involvement after chemoradiation in order to omit planned neck~     dissections in patients with locally advanced potentially operable, N2 and N3 head and neck~     squamous cell carcinoma (HNSCC).~      Primary study hypothesis: FDG PET/CT will have a negative predictive value (NPV) higher than~     90% to detect residual malignant lymph node involvement at 12 weeks after completing~     chemoradiation.~   "
143269|NCT01179347|"~     To date, there have been no formal clinical studies completed using tiotropium in CF~     patients. While there is a large body of evidence demonstrating the efficacy and safety of~     tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little~     is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis.~     Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic~     tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric~     and adult CF. The phase III trial (205.438) is a part of the approved Paediatric~     Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.~   "
143270|NCT01179334|"~     Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality.~     Although several drugs are available for the treatment of PAH none offer a cure, therefore~     there is still a high medical need for new treatments.~      Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling~     vascular tone, which is impaired in patients with PAH. This causes constriction and~     thickening of the blood vessels wall in the lungs and increase of blood pressure in the~     lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness~     of breath on exertion, collapse and often the inability of the patient to perform their~     daily life activities.~      Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears~     off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat~     may be a new approach for the treatment of PAH.~      The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH.~     The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate~     the effect of Riociguat on blood pressure in patients with PAH when given in combination~     with Sildenafil.~   "
143271|NCT01179321|"~     The purpose of this study is to determine the impact of malnutrition screening and nutrition~     intervention on acute aged care patient outcomes.~   "
143272|NCT01179308|"~     Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to~     general anesthesia alone.~   "
143273|NCT01179295|"~     This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral~     BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles~     in Japanese patients with advanced solid tumors~   "
143274|NCT01179282|"~     Subjects who have a clinical history of perennial rhinitis symptoms associated with dust~     exposure or not associated with other perennial allergens, will have a positive challenge~     with Dermatophagoides pteronyssinus. Subjects will be ppt negative and intradermal skin test~     positive to Dust p Challenges will be performed with placebo or Dp extract three times daily~     each for 2 weeks.~      Primary endpoint after nasal challenge with Dust p Mean Symptom score increase by greater~     than or equal to 2 from baseline. Secondary Outcomes Mean decrease in PNIF by greater than~     15percent from baseline. Mean increase in nasal lavage PGD2 and ECP by greater than~     15percent from baseline levels.~      Correlation between the orthogonol diameter of the wheal and flare of the intradermal skin~     test and the degree of symptom worsening during the nasal challenge.~      These results will provide evidence for the continued use of the intradermal skin test in~     evaluating allergic rhinitis.~   "
143275|NCT01179269|"~     Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new~     cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all~     lung carcinomas in Western countries. Surgical resection is the treatment of choice for~     patients with early stage disease (Stage I and II), but at least 50% of these patients will~     relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC~     are non-resectable at the time of their diagnosis due to either locally advanced or~     metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the~     overall 5-year survival rate less than 15%. The low survival rate may be attributed to the~     high incidence of unresectable disease at presentation and the inability of systemic therapy~     to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.~   "
143276|NCT01179256|"~     Curcumin has antioxidant properties and in animal models has numerous molecular targets,~     many of which are intracellular, such as transcription factors AP-1 and NF. As such, it~     inhibits the secretion of both pro-inflammatory (TNF-, IL-6) and anti-inflammatory (IL-10)~     cytokines, possibly by inhibiting transcription factors such as nuclear factor-B (NF-B) and~     activator protein-1 (AP-1) (Wong et al).~   "
143440|NCT01177267|"~     Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized~     opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one~     other prescription drug metabolized via the CYP450 system were evaluated for an incident~     drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic~     drug-drug interaction (DDI).~   "
143277|NCT01179243|"~     Recent research has focused on the investigation of sublingual microcirculatory alterations~     in different patient categories, like cardiac surgery and sepsis. The microcirculation plays~     a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark~     field (SDF) imaging.~      The objective is to carry out a international multi center study to investigate the~     prevalence of microcirculatory alterations in intensive care patients. Up to the present~     time, a comprehensive prevalence study like this has not been carried out.~   "
143278|NCT01179230|"~     Many stress tests being done today have two parts, the stress test and the pictures of your~     heart. The investigators are comparing a newer technique to obtain the pictures (PET~     imaging) to the standard method (SPECT imaging). However, it is not known if the new test is~     better than the old test. It is important to have a standard to compare these tests to, and~     that is why people who will be getting a cardiac catheterization are being asked to~     participate. The information about your arteries from the cardiac catheterization will be~     used to judge which stress test is better. The investigators hypothesize that the newer~     method (PET imaging) will be more accurate than the old method (SPECT) in detecting heart~     disease.~   "
143279|NCT01179217|"~     The purpose of this research is to test the effects of L-glutamine on red blood cells of~     patients with Sickle Cell Anemia or Sickle ß0-Thalassemia. Glutamine is a part of protein~     and is a part of a person's normal diet. It is often used as a nutritional supplement or as~     medication for various medical problems such as intestinal problems. The benefits of~     participating in this study may be a decrease in pain and other problems caused by sickle~     cell disease.~   "
143280|NCT01179204|"~     In this consecutive, prospective cohort study trial the investigators evaluate if~     preoperative pain response upon heat stimulation is predictive for acute and subacute~     postoperative pain after total knee arthroplasty.~   "
143281|NCT01179191|"~     The purpose of the research study is to find out if opioid dependent chronic pain patients~     who are judged by their physician to be eligible to change their current opioid medicine and~     to participate in this study can be successfully adjusted to a stable dose of EMBEDA~     (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's~     risk for prescription opioid abuse, misuse and diversion.~   "
143282|NCT01179178|"~     The investigators have taken part in the development of simple muscle function tests and~     studied physical training and energy turnover in patients with chronic obstructive pulmonary~     disease, COPD. The investigators have found that muscle wasting in COPD is related to poor~     prognosis and that physical training might lead to improved, less energy-demanding muscle~     function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor~     autonomy and, secondarily, fractures. In the planned study the investigators will validate~     simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps~     muscle strength, 30 m walking test and balance tests) in both groups by relating them to an~     involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition~     (impedance, DXA) and recordings of physical activity. The relation between food intake,~     systemic inflammation, muscle mass and function will be analysed.~      The study has been ethically approved and started in COPD patients and will be expanded to a~     representative sample of elderly.~      Simple, evaluated muscle function tests applied in primary care may be used for early~     detection of muscle dysfunction in COPD patients and elderly so that early intervention~     against impaired muscle function can be started. Analyses of food intake and of inflammatory~     markers might identify factors of special importance for muscle dysfunction, which~     eventually might lead to improved dietary therapy and pharmacological interventions.~   "
143283|NCT01179165|"~     The purpose of this study is to investigate the prevalence of cardiac disease/coronary~     artery disease and diagnostic yield of different non-invasive methods in patients with type~     2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic~     examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of~     coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest,~     and perfusion after vasodilatation stress will be used in the study. A subpopulation will in~     addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise~     training.~   "
143284|NCT01179152|"~     During the second week of September( week 38 of the year)there are recorded data of~     exacerbation of asthma all over the world, including Israel. A short preventive treatment of~     6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and~     hospitalization.~   "
143285|NCT01179139|"~     The purpose of the study is to better understand the causes of chronic rhinosinusitis~     (CRS)and to determine if being around secondhand cigarette smoke causes swelling in the~     sinuses. To answer this question, we are inviting healthy volunteers, volunteers with~     chronic sinusitis, and volunteers with chronic sinusitis with nasal polyposis to complete a~     questionnaire and undergo a series of tests. These tests will measure their allergies, their~     exposure to cigarette smoke and the swelling in their sinuses. We are asking you to take~     part because you are in one of these groups. About 166 people will take part in this~     research study. All subjects will be enrolled at Massachusetts General Hospital (MGH). The~     Flight Attendants Medical Research Institute (FAMRI) and the Harvard Clinical and~     Translational Science Center Harvard Catalyst) are paying for this study.~   "
143308|NCT01178840|"~     This is a comparative, open-label two-period crossover study of up to 505 couples comparing~     the PATH Woman's Condom to the FC2 female condom. California Family Health Council will~     enroll up to 505 couples to have 375 complete both periods. The study will provide data on~     functional performance, vaginal semen exposure, safety, and acceptability of the two female~     condoms.~      Both partners will be required to come to the clinic to be consented for the study. If both~     members of the couple meet all eligibility requirements, they will each sign an informed~     consent form and will be enrolled as a couple. The couples will be randomized to one of two~     female condom use sequences for the two periods (WC then FC2 or FC2 then WC). For the first~     period of 2-4 weeks, the couple will be asked to have sex once without a condom and 4 times~     using the first assigned female condom. For the second period of 2-4 weeks, the couple will~     be asked to have sex 4 times using the second assigned female condom. In the first period,~     the couple will have one act of unprotected sex for which they will collect pre- and~     post-coital vaginal swabs. The couple will also use 4 female condoms of the assigned type.~     They will be asked to collect pre- and post-coital vaginal swabs and a post-coital swab from~     the condom interior. The couple will complete a detailed Condom Use Questionnaire together~     after each condom use. An Acceptability Questionnaire will be completed separately by males~     and females at the end of each study period. Couples may have additional acts of sex during~     each period as they desire but will not have sex at least 48 hours prior to each study sex~     act. After a follow-up visit, the procedures will be repeated with 4 of the second assigned~     condom type but without the collection of vaginal swabs at unprotected intercourse. Each~     couple will be enrolled for about 2-3 months, depending on the intervals between sex acts.~     Clinicians evaluating product-relatedness of AEs will be blinded to the condom type used.~     Male partners will be requested to attend the final visit, and, if they experience adverse~     events, the followup and/or unscheduled visits.~   "
143286|NCT01179126|"~     Multivessel disease has been reported to occur between 40 and 60% of patients with~     ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse~     prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance~     of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions~     that can be potentially vulnerable, and the achievement of a complete revascularization,~     factor that is associated with a better prognosis. On the other hand, the prolongation of~     procedural duration, the hazard of contrast induced nephropathy and the peri-procedural~     complications can limit the widespread of this practice.~      To date, very few observational studies have focused in the multivessel revascularization~     with disparity of results. Whereas ones have observed an increase of adverse cardiovascular~     events and thus not recommend it, others have shown neutral results.~      Stress echocardiography has been shown to be an adequate technique for the diagnosis of~     coronary artery disease and could be an appropriate tool for selecting the lesions that need~     to be revascularized because they induce large areas of ischemia. However, this technique~     has also limitations like the high operator-dependence.~      Therefore, the investigators sought to study if the complete multivessel revascularization~     of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI)~     has an impact on prognosis compared to a strategy of treating only those non-culprit lesions~     that produce large areas of ischemia in a stress test.~   "
143287|NCT01179113|"~     The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly~     administered during surgery to help control blood pressure and heart rate, on postoperative~     pain levels and requirements for pain medication.~   "
143288|NCT01179100|"~     This study will evaluate the effect of intraoperative lidocaine infusion on postoperative~     orientation and concentration in elderly patients having general anesthesia for orthopedic~     surgeries requiring a minimum 2 days hospitalization.~      This study will also aim to determine whether intraoperative lidocaine infusion during~     general anesthesia improves recovery and patient outcome, as well as to determine whether~     lidocaine infusion decreases postoperative opioid (pain medication) usage.~   "
143289|NCT01179087|"~     The purpose of the study is to investigate the prevalence, clinical predictors and~     consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung~     transplant recipients.~   "
143290|NCT01179074|"~     To assess the benefits of oesophageal stenting and external beam radiotherapy over~     oesophageal stenting alone in patients with inoperable oesophageal cancer~   "
143291|NCT01179061|"~     The apelin-APJ system is a recently discover hormone system that has several important~     actions in the cardiovascular system. Apelin causes the heart pump with more force and also~     causes blood vessels to relax. Studies to date show that people with reduced pumping~     function of the heart have lower levels of apelin in the bloodstream compared to people with~     normal heart function. We have previously given apelin to healthy volunteers and people with~     reduced pumping function and this increases the heart's contraction. However, this has only~     been assessed over a short time period, around fifteen minutes, and we now want to know if~     this effect is seen over a longer period.~   "
143292|NCT01179048|"~     This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of~     this trial is to determine the long term effect of liraglutide on cardiovascular events in~     subjects with type 2 diabetes.~   "
143293|NCT01179035|"~     The purpose of this study is to study the effectiveness of the Transitions Clinic, a~     post-release clinic for parolees with chronic medical conditions, in achieving increased~     primary care engagement, lower rates of inappropriate hospitalizations, psychiatric~     emergency service and emergency department use, and decreased recidivism.~      We hypothesize that subjects receiving parolee-targeted care in the Transitions Clinic will~     have increased rates of non-emergency department ambulatory care and outpatient mental~     health care, lower rates of hospitalization, psychiatric emergency service (PES)~     utilization, emergency department (ED) utilization, decreased total hospital length of stay,~     and decreased recidivism compared to patients receiving primary care from other safety-net~     providers.~   "
143294|NCT01179022|"~     Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial~     Lesions~   "
143295|NCT01179009|"~     Treatment resistant depression (TRD) is a major public health problem. Current therapeutic~     options for this patient population remain limited. With all available treatments, only a~     sub-set of those patients who achieve an antidepressant response are likely to achieve~     treatment-induced remission. The need for antidepressant medication that can provide both~     rapid and long lasting relief of TRD symptoms is widely recognized. There is new evidence~     that drugs that block NMDA glutamate receptors (NMDA antagonists) are promising candidates~     for meeting this need. Existing studies in TRD have used only a low-dose, brief infusion of~     ketamine that would not be expected to re-sensitize the NMDA receptor; in agreement with~     this theory, these prior studies have found only temporary improvements of depression. Our~     key hypothesis is that a higher-dose, longer-term ketamine infusion, such as that used in~     chronic pain studies, would provide a more robust and lasting improvement from depression.~      Accordingly, we will be test whether a 100-hour ketamine infusion would be more effective~     than the standard 40-minute ketamine infusion currently used in other TRD studies. We will~     randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus~     clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following~     a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to~     minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).~      A subset of 20 patients with TRD will receive a 100-hour (+/- 4-hours)ketamine infusion with~     head MRIs pre (2) and post (1) infusion. Little research has been done on the mechanism of~     ketamine's putative antidepressant action. There is now a consensus that, in early stages of~     the novel treatment development for depression, clinical studies should be paired with~     mechanistic studies (neuroimaging) to understand the underlying mechanism and validate this~     as a treatment target. Ketamine is thought to have an antidepressant effect by increasing~     synaptic connections and therefore increasing connectivity in critical cognitive/emotional~     circuits.~   "
143296|NCT01178996|"~     The purpose of the study was to determine safety and efficacy of 48 weeks treatment with~     Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and~     ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and~     not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in~     comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and~     placebo.~   "
143309|NCT01178827|"~     This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®)~     and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with~     overactive bladder and age associated memory impairment.~   "
143441|NCT01177254|"~     Using a retrospective analysis of a large commercial claims database and a Medicare~     database, the investigators evaluated DDEs that have the potential to cause DDIs among~     chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes~     through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s).~   "
143297|NCT01178983|"~     In the recent decades, with technology development, computer workstation has become~     fundamental both at work and at home environments, and is now used routinely for many~     purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck~     and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since~     it has been found that many musculoskeletal disorders are connected, among others, to~     biomechanical and psychosocial factors relating to a person's work environment, the~     literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD~     include repetitive motions, awkward positions or static muscle loading over prolonged~     periods of time, use of high keystroke force, direct mechanical pressure, vibration and~     extreme temperatures. Computer operators found to be sitting statically for a long time in~     front of the computer and keyboard, with limited options of changing body position.~     Psychosocial factors have also been implicated in the workstation musculoskeletal disorders~     with computer operators. Workers with WRMSD may suffer from persistent pain, loss of~     function and work disability. Therefore, it may include changes in the employment and~     earnings for injured workers. The complex nature of these injuries suggests that workplace~     rehabilitation interventions are a crucial aspect of treatment management.~      The main objective of this study is to explore the use of biofeedback intervention, based on~     tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy~     will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be~     done by ANOVA Repeated Measures.~      Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found~     effective with computer operators suffer from WRMSD.~   "
143298|NCT01178970|"~     The aim of the study is to prevent falls related to poor lower body strength adn balance in~     the elderly.~   "
143299|NCT01178957|"~     The purpose of this study is to estimate the acute effect of hyperglycemia on~     Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.~   "
143300|NCT01178944|"~     This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients~     with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by~     surgery or has spread from the primary site (place where it started) to other places in the~     body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective~     treatment for esophageal, stomach, or gastroesophageal junction cancer.~   "
143301|NCT01178931|"~     The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and~     the vaginal progesterone, used for luteal phase support.~      (Initial start date was January 2009 but not for patients' recruitment only for paper work,~     documents, team organization, statistical pre-work actions and to gain the official approval~     of Institutional Review Board. The recruitment started in October 2010 and continued until~     October 2013.)~   "
143302|NCT01178918|"~     This is a prospective observational study with recruitment of healthy volunteers from~     consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and~     Allergic Diseases, Golnik, Slovenia.~      The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1~     vaccines.~   "
143303|NCT01178905|"~     To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the~     prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational~     age or <1500 g birth weight) under clinical conditions. Inactivation will be done only~     during the period of infectivity of breast milk, characterized by viral excretion strongly~     associated with subsequent infection, monitored by periodic virologic examinations of BM and~     urine of the infant. Thus the investigators hypothesis is that no CMV transmission through~     breast milk will occur using a gentle ultrashort heat inactivation procedure applied to~     infective breast milk.~      The protocol has been approved by the ethics committee of Tuebingen University Hospital.~   "
143304|NCT01178892|"~     This study is the second clinical trial to be conducted by the Menopause Strategies -~     Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of~     investigators conducting clinical trials designed to find new ways to alleviate the most~     common, bothersome symptoms of the menopausal transition.~      In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal~     transition or postmenopausal and experiencing bothersome hot flashes will be randomized to~     one of three behavioral intervention groups: yoga, exercise, or usual activity. All women~     will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.~      The primary aims of this trial are to compare the magnitude of changes in perceived,~     self-reported frequency and bother of vasomotor symptoms (VMS) before and after the~     intervention between yoga and the usual activity comparison group, between exercise and the~     usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.~     The hypotheses to be tested are:~        1. Women assigned to yoga will report lower frequency and less VMS bother than women~          assigned to the usual activity group at the end of a 12-week study period.~        2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower~          frequency and less VMS bother than women assigned to the usual activity group at the~          end of a 12-week study period.~        3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and~          less VMS bother than women assigned to the placebo group at the end of a 12-week study~          period.~      The omega-3 component of the study is double-blinded. For yoga, exercise, and usual~     activity, the outcomes assessors are blinded to the randomization assignments.~   "
143305|NCT01178879|"~     The purpose of this study is to determine whether telehealth nursing consultations of~     chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.~   "
143306|NCT01178866|"~     Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide~     partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to~     other classically studied markers as predictive factors of complicated clinical course after~     cardiac surgery in patients with left ventricular dysfunction.~   "
143307|NCT01178853|"~     This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug~     interaction study.~   "
143310|NCT01178814|"~     This is a prospective trial of Revlimid for subjects who have a blood cell cancer called~     myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that~     are carried from the genes. The amount of the message tells researchers if the protein it is~     going to make is high or low. This is known as expression of genes. The purpose of this~     study is to conduct a prospective trial testing the idea that expression of specific genes~     can help to predict which patients will respond to study drug administration with Revlimid~     (lenalidomide).~   "
143311|NCT01178801|"~     As a result of increasing adoption of health information systems in hospitals, more and more~     health records can be gathered and accumulated in the healthcare data repository. For this~     reason, the opportunity of analyzing and mining the healthcare data for quality improvement~     is increasing and becoming more and more important.~      The purpose of the project is to gather the clinical data relevant to liver cancer, and~     adopt the knowledge discovery and mining modules in information technology (IT) for~     analyzing and discovering the knowledge from the gathered clinical data.~      We can analyze the gathered clinical data for comparing the outcomes of different treatment~     strategies, finding out new diagnosis and staging criteria and factors, and other hidden~     knowledge included in the clinical data.~      Afterwards, the discovered results and the mining algorithms can be shared though the~     sharable knowledge mining platform provided by our project.~   "
143312|NCT01178788|"~     Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and~     17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of~     cervical shortening, in the present pregnancy.~      Main outcome: Delivery before 37 weeks.~      Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions~     before delivery, birth-weight centile, NICU admission, days of NICU admission, days of~     oxygen supply, composite neonatal complications, congenital neonatal malformations and~     anomalies.~      Allocated treatments will be:~      Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per~     vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical~     observation~      Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg~     repeated once 24 hours apart) will be permitted. Is not allowed the treatment with~     tocolytics per os. Any treatment will be recorded.~      Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit~     will be competitively assigned later. Results are expected 20-24 months from starting.~      Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50%~     (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160~     patients/arm, with a total of 480 patients.~      Data analysis: Methodological Unit will assign randomized treatment through a web site and~     it will collect data through the same way.~   "
143313|NCT01178775|"~     The aims of this three-year study are to:~        1. develop and validate a perceived meaning of fatigue scale~        2. examine the effect of individualized patient education and walking programs on~          alleviating fatigue in patients with gastric or colorectal cancer,and further explore~          the relationship between the perceived meaning of fatigue and intervention outcome.~   "
143314|NCT01178762|"~     Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also~     the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye~     infection has involved for a long time. The efficacy of single dose azithromycin has already~     been demonstrated as effective in the treatment of both trachoma and adult inclusion~     conjunctivitis.However, in our clinical experience, some patients of chlamydial~     conjunctivitis may require augmented single dose azithromycin treatments before C.~     trachomatis is eradicated. In this way, we would like to known the efficacy of single dose~     and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.~   "
143315|NCT01178749|"~     The aims of this three-year study are to explore symptom experience and its related factors~     for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin~     for 24 weeks and further to predict the relative risk of failure or occurence of severe side~     effects which interrupt the treatment.~   "
143316|NCT01178736|"~     The purpose of this study is to implement a community-based combined program for early~     detection of breast, cervical, ovarian and endometrial cancer in low-resource countries~     delivered through a free standing or a mobile Well Woman Clinic. The goals of this program~     are to downstage cancers and improve mortality rates using low-cost early detection methods.~     These programs will be implemented in regions where early cancer detection strategies are~     not in place and cancers present at advanced stages with resultant high mortality.~     Currently, there are three target project sites: Cambodia (June 2011), India (June 2011),~     and Brazil (March 2011). Memorandums of Understanding have been secured with local health~     organizations in each region to establish clinic operations. Each clinic would serve an~     approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000~     annually) will be invited to be screened for breast and cervical cancer over a three-year~     time span.~   "
143317|NCT01178723|"~     Studies has found a connection between breakfast consumption and obesity and obesity-related~     complications, but only few studies examined the effect of breakfast size.~      The purpose of this study is to examine the effect of breakfast size on several parameters~     in adults with Type 2 diabetes mellitus.~   "
143318|NCT01178710|"~     It is well know that statins have been used to low cholesterol to prevent and treat coronary~     artery disease for many years. It was also reported that statins could protect endothelial~     function and cardiac function during coronary artery bypass graft. However, some results~     were controversial. Also, there is no clinical data available on statin cardiac protection~     during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators~     are trying to see whether statins can protect heart injury during cardiac surgery in~     Chinese. Part of patients will receive statin treatment and part of will not before surgery~     in the study. Both patients' heart function will be measured and compared after surgery to~     determine whether statins can protect heart injury during heart surgery.~   "
143319|NCT01178697|"~     This randomized clinical trial is conducted to evaluate the effect of three intravitreal~     injections of bevasizumab versus two intravitreal injections of triamcinolone in acute~     central retinal vein occlusion. The outcomes are visual acuity and central macular~     thickness. The follow-up time is 6 months.~   "
143320|NCT01178684|"~     This study will provide the range of Epidermal Nerve Fiber Density (ENFD) typically seen in~     Thai individuals. ENFD values from Thai HIV-negative subjects without neuropathy will be~     used as appropriate reference norm for Thai HIV-positive subjects. In particular, comparison~     of ENFD values from Thai HIV-negative subjects with baseline ENFD values in Thai~     HIV-positive subjects prior to highly active antiretroviral therapy (HAART) will allow~     examination of the effect of HIV per se on ENFD. ENFD from Thai HIV-positive subjects on~     long-term d4T (stavudine) with and without neuropathy will also provide reference ENFD~     values at the extremes of the disease process i.e. extent of ENFD decrease in subjects with~     d4T-induced symptomatic neuropathy and in subjects completely free of disease despite d4T~     treatment for comparison with Thai HIV-positive subjects on short-term d4T in SEARCH 003~     study.~   "
143321|NCT01178671|"~     The overall goal of this study is to examine the efficacy of the combination of mirtazapine~     and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is~     FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine~     and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related~     disorder -- depression.~      In this study, sixty patients with chronic PTSD will be randomized to treatment with either~     sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a~     minimal response after 12 weeks will continue for another 12 weeks on the same treatment.~   "
143322|NCT01178658|"~     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,~     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation~     in patients with non-Hodgkin lymphoma.~   "
143323|NCT01178645|"~     The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide,~     cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation~     in patients with non-Hodgkin lymphoma.~   "
143324|NCT01178632|"~     Phase III, double blind, randomized study, controlled by Valeriana officinalis L for~     evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and~     Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and~     be followed by a post treatment visit.~   "
143325|NCT01178619|"~     Intrauterine growth restriction is being suspected in cases where the fetal estimated weight~     is less then the 10 th percentile for its gestational age. Abdominal circumference is the~     most influenced measurement in this cases. Head circumference on the other hand can be or~     not be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is~     constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR~     fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum~     growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this~     observational study we will include pregnant women between 28-37 gestational week with a~     singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and~     the CC, abdominal circumference, head circumference and femur length. we will compeer these~     measurements according to the following groups:normal fetuses, symmetrical and asymmetrical~     IUGR.~   "
143326|NCT01178606|"~     Sonographic coronal section in the lateral fetal ventricles shows echogenic area in the~     ventricles borders creating an halo around the ventricles. Histologically this area~     correlates to the Stratified transitional field. In this study we would like to measure this~     area for the purpose of creating a nomogram.~   "
143327|NCT01178593|"~     This randomised controlled trial (RCT) aimed at assessing the efficacy of hypnotherapy in~     group sessions (GHT) with a 12-months follow-up.~   "
143328|NCT01178580|"~     Community acquired pneumonia (CAP) is still one of the most important causes of morbidity in~     adults. (1) In severe cases, parapneumonic effusions or empyema may develop. In these~     patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory~     response as seen in sepsis.~      The aim is to study the fibrinolytic activity in patients with CAP alone versus CAP with~     parapneumonic effusions with and without empyema.~   "
143329|NCT01178567|"~     Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and~     laparoscopic adjustable gastric banding.~   "
143330|NCT01178554|"~     The Clinic Treatment Project tested two alternative methods of delivering evidence-based~     practices within public community-based mental health clinics, using training and~     supervision procedures designed for the settings and users.~   "
143331|NCT01178541|"~     Study designed to measure simultaneously the width of both lateral ventricles of the fetal~     brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right~     and the left ventricles during the pregnancy.~   "
143332|NCT01178528|"~     Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological~     interventions have been proven effective in improving exercise capacity. At the presence~     there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity.~     Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left~     ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol~     has been proven effective in increasing exercise tolerance in patients with ischemic heart~     disease. Aim of the present study is to evaluate the effect of heart rate reduction with~     ivabradine, carvedilol or their combination in patients with heart failure of ischemic~     origin.~   "
143333|NCT01178515|"~     Substituting whole milk intake for defatted milk will improve indicators of cardiovascular~     risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density~     Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of~     Mexican children 6-13 years of age.~   "
143334|NCT01178502|"~     To develop and validate the predictive warfarin dosing algorithm.~   "
143335|NCT01178489|"~     To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately~     after fast-track hip and knee arthroplasty.~   "
143348|NCT01178320|"~     Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading~     cause of death in the United States. Unstable plaques often have more fat than stable~     plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising~     compared with LDL-lowering alone would more effectively reduce the plaque fat content~     assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and~     strokes.~   "
143336|NCT01178476|"~     Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of~     hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic~     control, which in turn leads to increased diabetes related morbidity and mortality.~      Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with~     characteristic changes in EEG with a decrease in alpha activity and an increase in delta and~     theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can~     be recorded from subcutaneously placed electrodes using an automated mathematical algorithm~     based on non-linear spectral analysis. Experimental findings hold promises that an alarm,~     given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by~     ingestion of carbohydrate.~      This is the first larger scale trial testing the clinical applicability of a~     hypoglycaemia-alarm based on real-time analysis of EEG-signals.~   "
143337|NCT01178463|"~     The researchers hypothesized that nonobstructive azoospermia might be associated with a~     reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia.~     Testicular sperm specimens that had been previously extracted from azoospermic patients will~     be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections~     will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary~     antibodies. Those found to be SSCs will be counted using light microscopy, and compared~     between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).~   "
143338|NCT01178450|"~     The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive~     surgery is superior to cinacalcet for the treatment of persistent secondary~     hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly~     reduces the cost of treatment post transplant.~   "
143339|NCT01178437|"~     The aim of the study is to prove the feasibility and safety of transcutaneous, electrical~     stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.~   "
143340|NCT01178424|"~     Major depressive disorder (MDD) continues to have a profound impact on individuals,~     families, and the health care system. Despite marked success in treating active individual~     episodes of unipolar depression, our understanding of the neural and cognitive mechanisms~     involved in the return of symptoms remains extremely limited, and few interventions exist~     that specifically target factors involved in prophylaxis. The research being proposed is~     among the first that is designed to examine neurocognitive markers for depressive relapse~     vulnerability and link them directly to clinical prognosis.~      Hypothesis 1: Cortical midline structures (CMS) network recruitment will be associated with~     behavioural and neural indices of a reflexive attentional bias towards dysphoric stimuli in~     a divided attention task.~      Hypothesis 2: Behavioural and neural indices of dysphoric attentional bias following mood~     challenge will predict depression relapse in prospective 18-month follow up.~      Hypothesis 3: Relative to CBT, Mindfulness Based Cognitive Therapy (MBCT) will normalize CMS~     and right insular/fronto-opercular cortices (INS-FO) network imbalance.~      Hypothesis 4: Relative to CBT, MBCT will normalize to healthy control levels, behavioural~     and neural indices of dysphoric attentional bias, which will be predictive of reduced~     relapse risk across a 24 month follow up.~   "
143341|NCT01178411|"~     This is an extension study that will allow patients to continue to receive study treatment~     when the original studies into which they were enrolled have reached their designated~     end-dates.~   "
143342|NCT01178398|"~     Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential~     nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial~     for the developing fetus, yet potentially toxic because of mercury contamination, have~     created uncertainty about the appropriate fish consumption advice to provide pregnant women.~     The investigators objective was to determine knowledge, behaviors, and received advice~     regarding fish consumption among pregnant women who are infrequent consumers of fish.~   "
143343|NCT01178385|"~     Autism spectrum disorders affect as many as 1 out of 150 children and are related to~     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,~     such as anxiety, are common and may cause substantial distress and impairment beyond that~     caused by the autism diagnosis. Although effective interventions have been developed for~     typically developing youth with anxiety disorders, this approach needs to be adapted for~     children with autism. Accordingly, we are proposing a randomized controlled trial to examine~     the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with~     autism spectrum disorders and comorbid anxiety disorder(s).~   "
143344|NCT01178372|"~     Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in~     approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable~     disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of~     minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators~     will assess the effects of lactulose and probiotics for the prevention of recurrence of HE~     (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic~     encephalopathy.~   "
143345|NCT01178359|"~     Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than~     20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation~     from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac~     arrest and our group is eager to test this hypothesis in a clinical trial. Our overall~     hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will~     increase the proportion of patients who will survive cardiac arrest. In preparation for a~     clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the~     primary goal of this study.~   "
143346|NCT01178346|"~     The purpose of this study is to look at pharmacoeconomic data for subjects that have~     received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.~   "
143347|NCT01178333|"~     HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between~     1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse~     information that is already in the patients' medical records. Information about laboratory~     values (such as platelet counts), treatments (such as medications), and outcomes (such as~     blood clots, amputation, and death) will be included.~   "
143832|NCT01171976|"~     The purpose of this study is to demonstrate that two investigational treatment regimens have~     the potential to result in a superior visual acuity improvement as compared to a ranibizumab~     pro re nata (PRN=as needed) treatment regimen.~   "
143349|NCT01178307|"~     The goal of this research study is to better understand the symptoms experienced by patients~     with GIST.~      There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews~     and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to~     patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In~     Part 3, participants will complete questionnaires about GIST symptoms over 1 year.~      You are being asked to take part in Part 3 of the study.~   "
143350|NCT01178294|"~     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment~     of serious bleeding episodes in people with acquired hemophilia A.~   "
143351|NCT01178281|"~     The objective of this study is to determine whether pomalidomide is safe and effective in~     reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative~     neoplasm (MPN)-associated myelofibrosis. (Global Study) and to describe the frequency of~     anemia response to pomalidomide in Chinese participants with MPN-associated myelofibrosis~     and severe anemia not receiving REC-transfusions (China Extension Study only)~   "
143352|NCT01178268|"~     This is a prospective, randomized, active-controlled, open label, parallel two-arm,~     multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER~     SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) (CYPHER SELECT PLUS) during~     commercial use in China.~   "
143353|NCT01178255|"~     To assess the two components of individualized homeopathic treatment for acute depression,~     i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to~     investigate the effect of different approaches to the homeopathic case history~     taking(defined in this study as case history taking type I and II).~   "
143354|NCT01178242|"~     The purpose of this study is to evaluate salivary gland and labial mucous membrane~     transplantation in patients with severe symblepharon and dry eye secondary to~     Stevens-Johnson Syndrome (SJS).~   "
143355|NCT01178229|"~     Objective: to evaluate the effects of physiotherapy on the anteroposterior airway size in a~     group of bruxist children~      Question: Is a physiotherapeutic technique aiming at changing the head posture, effective to~     increase the anteroposterior dimensions of the upper airway in bruxist children?~      Hypothesis: The bruxist children treated with physiotherapy will present higher airway~     dimensions~      Design: randomized clinical trial with allocation and blinding of the examiners.~      Participants: 3 to 6 year old children with complete primary dentition, dental and skeletal~     class I occlusion. The participants were classified as bruxist according to the minimal~     criteria of the ICSD for bruxism. The children were randomized in an experimental (n=13) and~     a control (n=13) group.~      Intervention: A physiotherapeutic intervention using the Awareness through movement~     technique was applied to the children of the experimental group once a week, until 10~     sessions were completed.~      Outcome measures: anteroposterior measurements of the nasopharynx, oropharynx and~     hypopharynx taken in a lateral cephalogram with standardized techniques.~   "
143356|NCT01178216|"~     Organ transplantation offers the only hope for a normal life for patients with end-stage~     renal disease on dialysis (ESRD). For patients with antibodies to human leukocyte antigens~     (HLA), transplantation is extremely difficult or impossible since pre-formed antibodies will~     cause severe rejection and loss of transplanted organs. Intravenous gamma globulin (IVIG)~     can reduce or eliminate these antibodies in most patients and allow for successful~     transplantation. This breakthrough has allowed patients previously considered not~     transplantable to receive life-saving transplants. However, IVIG alone does not always~     eradicate the anti-HLA antibodies to a degree that will allow transplantation to proceed.~      In this study, the investigators propose to add an additional treatment (Rituxan), a~     humanized antibody directed at the CD20 antigen that is present on most B-cells (B-cells~     make antibodies, this Rituxan should help eliminate the source of anti-HLA by deleting the~     cells that make it).~      Both IVIG and Rituxan are approved by the U.S. Food and Drug Administration (FDA) for~     numerous immunologic disorders and Non-Hodgkin's lymphoma, respectively. However, neither is~     yet approved by the FDA for desensitization of highly-HLA sensitized transplant patients.~      Previously conducted pilot study demonstrated that IVIG + Rituxan can fill an important gap~     in our current therapeutic approach for management of highly sensitized patients and it may~     become the standard approach to manage these patients.~      This study has been recently updated after observation that subjects transplanted after~     desensitization with IVIG alone experienced higher rates of antibody rejection and graft~     loss.~      The primary objective of this revised protocol will be to examine the safety and efficacy of~     IVIG 2gm/kg (maximum dose 140g) given on day#0 & day #30 plus Rituximab 1gm given on day~     #15. Transplanted patients will receive additional doses of Rituximab 1gm at 3 months~     post-transplant if donor specific antibody (DSA)levels remain or become positive or at 6M if~     de novo DSA occur. All transplanted patients who remain DSA negative, will not receive~     additional Rituximab. All transplanted patients will have a protocol biopsy at transplant~     and at 12 months. All subjects will have to complete 5 visits in a pre-transplant phase of~     the study. Patients who are transplanted will have additional 5 post-transplant visits. The~     following are research-related procedures:~        1. Rituxan infusion.~        2. Kidney allograft biopsy (Intra-op and 12 months post transplant)~        3. Rituxan level, HACA levels~        4. Immunologic biomarkers (CD19+, CD38+, CD27+)~      Although Dr. Jordan commonly uses both treatment regimens at Cedars-Sinai Medical Center,~     only the IVIG treatment is considered to be standard of care for highly HLA-sensitized~     patients. The investigational component of this study is the addition of the Rituxan and~     currently the study has been ammended to a safety and efficacy study focusing on decreasing~     HLA antibodies pre-transplant and minimizing DSA post transplant.~   "
143357|NCT01178203|"~     Aim: eliminating or reducing pain following endodontic treatment is of great importance. The~     aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on~     post-operative pain following instrumentation of root canals in teeth with irreversible~     pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria~     were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on~     post-operative pain following instrumentation of root canals in teeth with irreversible~     pulpitis was evaluated.~   "
143358|NCT01178190|"~     Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light~     enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this~     study investigate its better diagnostic yield in the assessment of lung cancer than~     conventional flexible bronchoscopy.~   "
143359|NCT01178177|"~     Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects~     recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced~     neutropenia.Although both of these populations are at high risk for IPA, they differ with~     regards to the specific defects in host defense mechanisms that increase their risk for IPA.~     Chemotherapy- induced neutropenia is the principal defect affecting patients with~     hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells~     and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of~     IPA-related infection and inflammation may differ according to the type of underlying immune~     defect. Although the clinical and radiological features of IPA in patients with neutropenia~     have been extensively studied, little is known about the characteristics of IPA in SOT~     recipients. The investigators therefore compared the IPA- related clinical and radiological~     findings in SOT recipients with those of neutropenic patients.~   "
143833|NCT01171963|"~     The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK~     Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.~   "
143360|NCT01178164|"~     Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by~     alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost~     all tissues examined. Signs of the disease appear earlier and are more severe in affected~     males than in females. Myocardiopathy, renal failure and neurological signs including~     chronic pain and peripheral neuropathies are the most frequent signs. The availability of~     two enzymatic replacement therapies now provides a specific and effective treatment for~     patients. The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of~     Fabry disease has previously been estimated in several series of patients presenting one~     single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However,~     no data are available about the prevalence of FD in populations of patients suffering from~     chronic pains of unknown origin.~      The diagnosis of FD will be performed by standard procedures following international~     recommendations. These require the search for a deficiency of alphagalactosidase A activity~     on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).~      The patients in whom the diagnosis of FD is established during this study, will be call in~     for an additional visit in the Investigating Centre in order to confirm the diagnosis and~     propose suitable assessment and care.~   "
143361|NCT01178151|"~     In this pilot study the investigators will treat all patients known with Peutz-Jeghers~     syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until~     disease progression. Most patients with PJS have an inherited LKB1 mutation leading to~     aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably~     related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an~     effective anticancer treatment in PJS patients with advanced malignancies.~   "
143362|NCT01178138|"~     This protocol will test the safety, effectiveness and the metabolism and action of prazosin~     as a potential therapy for methamphetamine abuse. This will be accomplished by performing a~     series of human laboratory studies. In each of these studies, the safety and effectiveness~     of the test medication (prazosin) in the treatment of methamphetamine effects will be~     determined. The study hypothesis is that prazosin will block the methamphetamine receptor~     function, reducing the reinforcing effects of central nervous system effects in humans.~   "
143363|NCT01178125|"~     This is an open-label, single treatment study. All subjects will receive 12 months of oral~     contraceptive therapy with DR-102. Study participants will receive physical and~     gynecological exams, including Pap smear. During the study, all participants will be~     required to complete a daily diary.~   "
143364|NCT01178112|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of trientine and carboplatin that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~   "
143365|NCT01178099|"~     The purpose of this study is to measure the exposure to prasugrel's active metabolite and~     the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).~   "
143366|NCT01178086|"~     This observational study will assess the therapeutic efficiency, the treatment schedules and~     handling procedures, and the safety profile of MabThera/Rituxan (rituximab) in routine care~     in patients with chronic lymphocytic leukemia. Data from patients will be collected for a~     total of 24 months.~   "
143367|NCT01178073|"~     The purpose of this study is to compare the two treatment strategies; first-line combination~     therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil)~     in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first~     clinical failure event.~   "
143368|NCT01178060|"~     The goal of this research is to improve communication to Veterans. The investigators want to~     improve how doctors and nurses talk to patients about the risk of heart attack and stroke.~     The investigators will give everyone in the study information about the risk for heart~     attack or stroke. The investigators will also provide information on how to reduce this~     risk. This information will be given in one of two ways. The investigators want to see which~     way of giving information works better for veterans. The investigators also want to assess~     the impact of personalized stroke risk communication to patients at risk for stroke on~     patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the~     impact of personalized risk communication on medication adherence and blood pressure. The~     investigators plan to enroll approximately 100 veterans for this study. All veterans will be~     from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the~     study for 3 months.~   "
143369|NCT01178047|"~     Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the~     quality of life of affected patients.~      Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase~     type-B (MAO-B) inhibitor with a 24h dopaminergic effect.~      It is well known that dopaminergic treatment closely interacts with SWD. This study aims to~     assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind,~     placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline~     1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss~     centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease~     Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue~     Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan~     scale) and QoL in PD patients.~        -  Trial with medicinal product~   "
143370|NCT01178034|"~     Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a~     new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR~     value at day five after four days of 5 mg/day warfarin. To this end patients with atrial~     fibrillation starting warfarin are randomized in two arms.~   "
143395|NCT01177852|"~     Multicenter clinical trial, phase III, controlled by active medicine, open, randomized,~     enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway~     characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and~     no more than 5 consecutive days (without systemic/topic use of medication during this~     period) followed by nasal congestion, with or without associate other nasal symptoms~     (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated~     in 2 parallel groups, and will receive the medicines of study, according of the~     randomization.~   "
143396|NCT01177839|"~     This prospective study aims to estimate the incidence of intussusception among children < 2~     years old through hospital-based surveillance in Singapore.~   "
143371|NCT01178021|"~     This is an open label two-arm randomized prospective study of two treatments for P. vivax~     malaria. Patients meeting study inclusion criteria will be enrolled and allocated either~     chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will~     be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients~     with recurrent P. vivax infection will be treated with the same medication as initially~     randomized unless contraindicated. Recurrences in the two arms will be compared to estimate~     the risk of and mean duration to relapse, classify the relapse pattern as early or late~     relapse and to estimate the efficacy and safety of the study drugs.~      Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish~     between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be~     collected on day 7 from each study subject as well as on the day of recurrence if within 8~     weeks of chloroquine~   "
143372|NCT01178008|"~     The proposed study is a randomized controlled trial to examine the efficacy and safety of~     active acupuncture versus placebo acupuncture for the treatment of postpartum depression.~     The investigators hypothesis is that active acupuncture would be superior to placebo~     acupuncture in the short-term treatment of postpartum depression.~   "
143373|NCT01177995|"~     This study is a randomized outcome trial of a social network HIV prevention intervention for~     at-risk labor migrants who have arrived in St. Petersburg, Russia, to seek work. Most come~     to St. Petersburg from Moldova, Tajikistan, Uzbekistan, Ukraine, and other poor post-Soviet~     republics. While living in Russia, labor migrants are also living in a city and country with~     high HIV prevalence. Many labor migrants have limited awareness of AIDS, and most are living~     in a location far from their spouses, family members, and others. For that reason, labor~     migrants are vulnerable to risk behavior for contracting HIV.~      This study hypothesizes that members of labor migrant social networks whose network leaders~     are trained to deliver HIV prevention messages will exhibit greater reductions in sexual~     risk behavior (unprotected intercourse with nonspousal partners) from baseline to 3- and~     12-month followup assessments than will members of social networks whose members receive~     standard, individual HIV risk reduction counseling alone.~   "
143374|NCT01177982|"~     Objectives: This project is a Stage II behavioral development study designed to answer~     remaining critical questions necessary before disseminating Reinforcement Based Treatment~     (RBT) to the larger treatment community. These questions focus on the levels of intensity of~     RBT most efficacious for substance-using pregnant patients. Design: The proposed study~     utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple~     assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at~     treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All~     participants will receive a subsequent randomization based upon an assessment of their~     initial two weeks of treatment compliance. Early-non-compliant participants will be~     randomized to receive either the same or an increased level of RBT treatment intensity while~     early-compliant participants will be randomized to receive either the same or decreased~     level of treatment intensity and scope. Primary outcome measures include treatment~     completion, and maternal heroin, cocaine, and other illicit substance use. Secondary outcome~     measures include maternal measures of HIV risk behavior, and psychosocial functioning and~     neonatal measures of length of hospitalization, and birth outcomes. Significance: The~     proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model,~     application of advanced statistical techniques and inclusion of a cost-effectiveness~     approach. The proposed project's significance is exceedingly high, as it will lay the~     foundation for later Stage III studies focused on dissemination of stepped care treatment~     programs for drug-addicted pregnant women that can be implemented not only in comprehensive~     care clinics but in diverse community settings that provide services to such women.~   "
143375|NCT01177969|"~     Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders,~     causing substantial distress and impairment over and above the autism spectrum diagnosis~     alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically~     developing youth with an anxiety disorder and when adapted, shows promise in children with~     ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to~     meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid~     anxiety. Given this, the present study seeks to develop and test a new CBT therapy in~     adolescents with autism and comorbid anxiety.~   "
143376|NCT01177956|"~     The primary objective of this trial is to assess the antitumor activity and safety profile~     of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the~     first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck~     (SCCHN) in Asian subjects.~   "
143377|NCT01177943|"~     To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4~     milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per~     capsule) in healthy adult male Japanese subjects.~   "
143378|NCT01177228|"~     The main objectives of this study were to evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in~     patients with ulcerative colitis (UC).~   "
143379|NCT01177215|"~     The purpose of this study is to reduce the length of drainage using a treatment protocol to~     control the manipulation of the applied vacuum to the pleural cavity.~   "
143380|NCT01177202|"~     The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A~     H1N1 Vaccine In Healthy Adults~   "
143381|NCT01177189|"~     The purpose of this study is to understand why and how oxidative stress negatively impacts~     mobility in the elderly, and to determine whether antioxidant supplements can increase~     vascular health and mobility.~   "
143397|NCT01177826|"~     The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing~     rotavirus severe gastroenteritis among hospitalized infants, in Belgium.~   "
143398|NCT01177813|"~     The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773~     compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM~     with insufficient glycaemic control. For the open-label part of the study the objective is~     to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with~     T2DM with very poor glycaemic control.~   "
143399|NCT01177800|"~     The purpose of this study is to determine the superiority and efficacy of infliximab~     induction therapy in chinese participants with moderate to severe plaque-type psoriasis~     (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug~     to test whether the drug has a real effect in a clinical trial).~   "
143400|NCT01177787|"~     The aim of this study is to evaluate the clinical efficacy of reduction of local fat on~     ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude~     modulated frequency (conventional) method.~   "
143382|NCT01177176|"~     Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million~     U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related~     disease or death. A hospital admission provides an opportunity for a smoker to quit. Smoking~     cessation counseling provided in the hospital is effective, but only if it continues for >1~     month after discharge. Smoking cessation medications add benefit to counseling but are not~     often used. The challenge is to translate this efficacy research into routine clinical~     practice. The major barrier is to make the transition from inpatient to outpatient care. An~     evidence-based, cost-effective intervention model that can be adopted by U.S. hospitals is~     needed to realize the potential impact of hospital smoking interventions.~      The Specific Aim of this project is to conduct a randomized controlled comparative~     effectiveness trial of two strategies to promote smoking cessation in hospitalized patients:~     (1) a hospital-only intervention that meets the current standard of the National Hospital~     Quality Measures(Standard Care), and (2) an Extended Care Management model with 2~     components that aims to encourage and facilitate the sustained use of smoking cessation~     treatment (counseling and medication use) after discharge in order to achieve long-term~     abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and~     feature 2 innovations: (1) to increase medication use, smokers willing to make a quit~     attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking~     cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness,~     interactive voice recognition (IVR) technology is used to make automated telephone calls to~     identify the smokers interested in or most likely to benefit from continued counseling after~     discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General~     Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after~     hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care,~     is feasible and will increase (1) the use of smoking cessation treatment after discharge,~     (2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence~     6 months after hospital discharge (primary outcome). The principal secondary outcome measure~     is self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other~     secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months,~     prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The~     cost-effectiveness (cost per quit) of the interventions will be also be compared.~   "
143383|NCT01177163|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects~     and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with~     Type 2 Diabetes Mellitus who are on a stable dose of insulin.~   "
143384|NCT01177150|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male~     volunteers. The study will evaluate the PK and PD effects of study drug in volunteers who~     fasted compared to those who did not fast before study drug administration.~   "
143385|NCT01177137|"~     The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the~     efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating~     tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound~     therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus,~     its perception, and ultimately, its impact on the patient's life.~   "
143386|NCT01177124|"~     The purpose of this study among breast cancer survivors is three-fold: (i) to evaluate the~     efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality~     of life and measures of immune function and a stress hormone (cortisol); (ii) to test~     whether positive effects achieved from the MBSR(BC) program are mediated through changes in~     mindfulness and fear of recurrence of breast cancer; and (iii) to evaluate whether positive~     effects achieved from the MBSR(BC) program are modified by specific patient characteristics~     measured at baseline.~   "
143387|NCT01177111|"~     Each year four million babies die during the neonatal period, with the majority occurring in~     developing countries. Overall, infections account for one-third of all neonatal deaths, with~     proportions approaching 50% in settings where neonatal mortality rates are high. Infections~     are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The~     investigators long term goal is to identify simple, affordable, and effective interventions~     that can be delivered at the community level in low-resource settings to reduce neonatal~     mortality risk due to these infections. The investigators team has conducted research in~     this area for the past 10 years, with specific focus on newborn vitamin A dosing and topical~     chlorhexidine antisepsis interventions. Previous community-based research by the~     investigators group of investigators and others demonstrated that newborn vitamin A dosing~     can reduce early infant mortality by approximately 20%, and that topical applications of~     chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality~     risk by 24%. Evidence is growing that neonatal skin plays an important role in protecting~     the newborn infant from invasive pathogens. Barrier function of the neonatal skin, however,~     is incomplete in newborn infants, especially those that are pre-term or of low birth weight.~     Full-body massage of newborns with mustard oil, practiced almost universally (~95%) in~     communities of south Asia, may further compromise skin barrier function through decreased~     structural integrity leading to increased trans-epidermal water loss and increased risk of~     percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen~     after massage of neonatal skin with alternative topical emollients, including sunflower seed~     oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin~     barrier function, improve skin condition, and reduce the risk of both nosocomial infections~     and neonatal mortality among hospitalized newborns in low-resource settings. The specific~     hypothesis of this study is that substituting mustard oil with sunflower seed oil for~     topical applications during full body massage of newborns in the community will reduce~     neonatal mortality and morbidity by improving overall skin barrier function and reducing~     exposure to invasive pathogens.~   "
143388|NCT01177098|"~     This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A~     ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once~     daily for 12 weeks in patients with glaucoma or ocular hypertension.~   "
143389|NCT01177085|"~     This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical~     parameters following a weight-control diet using either standard food guide pyramid alone,~     or standard food guide pyramid with substitution of mushrooms for meat.~   "
143390|NCT01177930|"~     The purpose of this study is to evaluate the influence of the type of feeding in the first~     year of life on the behavior and health-related quality of life at 6-8 years of age.~   "
143391|NCT01177917|"~     This clinical trial will help determine if prebiotics can increase mineral absorption in~     babies~   "
143392|NCT01177904|"~     There seems to be a general consensus on the supplementation of progesterone (P4) for luteal~     phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However,~     there is no agreement about the precise duration of LPS.~   "
143393|NCT01177891|"~     The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who~     induced estrogen deficiency and often leads to infertility final. The etiologies of POF~     remain unknown in more than 85% of cases. There are 5-10 % of familial cases.The main~     objective of this study is to recruit, phenotype and genotype 20 families with at least two~     subjects with nonsyndromic POF in order to identify new loci using a single technical~     standard nucleotide polymorphisms (SNPs). This study will also include related population~     and population control.~   "
143394|NCT01177865|"~     RATIONALE: Gathering information about patients with prostate cancer may help doctors learn~     more about how patients choose treatment options.~      PURPOSE: This study is looking at treatment choice in patients with localized prostate~     cancer.~   "
143401|NCT01177774|"~     The purpose of this research is to study why most children who have tics never develop~     Tourette syndrome but some do. In other words, we aim to find features that may predict~     whose tics will go away and whose tics will continue or worsen, in children ages 5 through~     17 years whose first tic occurred within the past 6 months.~   "
143402|NCT01177761|"~     The study determines the long-term effect of exercise on osteoporotic fracture risk. Since~     actually no controlled supervised exercise study exceeds the time frame of 4 years,~     knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors~     is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled~     exercise study with currently 16 years of supervised exercise with 45-50 osteopenic,~     early-postmenopausal women in exercise and sedentary control group each, the investigators~     therefore focus on overall-fractures, Bone Mineral Density and falls.~   "
143403|NCT01177748|"~     Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative~     for the stroke mainly in case of atrial fibrillation but on the other hand present severe~     complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial~     infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac~     arrhythmia in the acute phase of stroke care thus have an important role not only for~     adjusting the correct secondary prevention but also to prevent cardiac complications~     potentially reducing morbidity and mortality.~      The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade~     arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the~     first days after stroke onset. In addition, it evaluates different strategies to identify~     paroxysmal atrial fibrillation.~   "
143404|NCT01177735|"~     This is a phase II study, open-label, single institution trial of pomalidomide in~     GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have~     included lenalidomide. Patient accrual is 30 over a 2 year period.~      Primary objective:~        -  To determine progression-free survival (PFS) after initiation of pomalidomide therapy~      Secondary objective:~        -  To determine the response rate (CR, n-CR, VGPR) and duration of response after~          pomalidomide therapy.~        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of~          initiation of daily pomalidomide dosing.~        -  To determine gene expression profiling (GEP) changes exerted within 48 hours of~          initiation 3 concurrent days of exposure to lenalidomide.~        -  To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6~          month examinations.~   "
143405|NCT01177722|"~     The purpose of this study is to generate immunogenicity and safety data of an~     investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine,~     Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.~      Primary Objectives:~        -  To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T~          vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with~          Prevenar™ and Rotarix™, in terms of immunoresponses.~        -  To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to~          the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.~      Secondary Objectives:~        -  To describe in each group the immunogenicity parameters for all antigens for each~          vaccine~        -  To assess the safety profile in terms of solicited and unsolicited adverse events and~          serious adverse events in each group for each vaccine.~   "
143406|NCT01177709|"~     Study hypothesis is that patients on antipsychotics medication treated with metformin will~     show loss in weight and improved measures of glucose metabolism.~   "
143407|NCT01177696|"~     Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of~     sanitary problems in adults with chronic diseases, they usually have a lack of experience in~     development of psychotherapeutic interventions. However, these interventions are the ones~     that achieve better results to reduce symptomatology and improve emotional state of~     caregivers.~      The study aims to evaluate the effectiveness of an intervention of psychotherapy in~     improving the mental health and quality of life of caregivers. This intervention is based on~     theoretical approaches to care adjusted to cognitive theory, in order to be applied in~     primary health care centres.~      To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly~     face the care.~   "
143408|NCT01177683|"~     This is an open label phase I/II trial to determine the safety and the biologic activity of~     the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.~   "
143409|NCT01177670|"~     The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on~     the efficacy and safety of the Adiana Permanent Contraception System in the post market~     setting. Specifically, data will be collected that is relevant to the evaluation of the~     safety and efficacy of the Adiana System for women who desire permanent birth control by~     occlusion of the fallopian tubes. This study is an observational study that is not intended~     to test specific hypotheses.~   "
143410|NCT01177657|"~     The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™~     vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in~     Belem area, Brazil.~   "
143411|NCT01177644|"~     This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients~     with neovascular AMD.~   "
143412|NCT01177631|"~     This is a pilot study to evaluate the difference between the protein expression between~     hepatocellular carcinoma and tumor with vessel invasion in Asian patients with~     hepatocellular carcinoma.~   "
143413|NCT01177618|"~     Chronic obstructive pulmonary disease (COPD) is often caused by cigarette smoking, but~     genetic predisposition also influences COPD susceptibility. The purpose of this study is to~     identify genetic factors that predispose some individuals to develop COPD.~   "
143414|NCT01177605|"~     This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness,~     stool patterns and growth of two cow's milk-based beverages for children.~   "
143422|NCT01177501|"~     The early relapse of ovarian cancer occurring within 6 months of chemotherapy including~     platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly~     of their disease. For relapses occurring between 6 and 12 months, no recommendation occur~     and few studies are conducted. Therefore it seems interesting to develop a research on~     intensive chemotherapy using a combination of carboplatin (a drug widely used in most~     ovarian cancer) with Topotecan , use in a high dose protocol. Topotecan has demonstrated its~     efficacy in relapse ovarian cancer and its possible use in high doses, a recent study~     (ITOV01) have demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD~     set at 9 mg / m² / dx 5 days). This project is a feasibility research of the combination of~     topotecan and carboplatin in a high dose escalation protocol for early ovarian cancer~     relapse occurring 6 to 12 months after conventional chemotherapy-based platinum salts.~   "
143415|NCT01177592|"~     This is a prospective, single-center, randomized trial including 1500 subjects requiring~     PCI. Subjects with ischemic heart disease due to stenotic lesions in either native coronary~     arteries or coronary artery bypass undergoing PCI with stent placement and no~     contraindication to prolonged dual antiplatelet therapy (≥1 year) are eligible to be in the~     study. Subjects will be randomized to either guided antiplatelet therapy arm (n=750) or~     standard therapy arm (n=750) and undergo laboratory testing, antiplatelet adjustment, and~     clinical follow-up for 1 year.~      Patients (non-emergent) presenting for PCI will receive standard pre-procedural PCI care as~     outlined by the current ACC/AHA guidelines. Subjects will be consented peri- PCI (prior to~     or within 24 hours of PCI) and then randomized (1:1 ratio) to guide or standard non-guided~     (control) antiplatelet therapy. Physicians will be blinded to genotyping and platelet~     function results for subjects randomized to the standard therapy group for the duration of~     the study or if endpoint is met. Subjects on chronic clopidogrel or prasugrel therapy (≥ 2~     weeks) will be guided by VerifyNow P2Y12 assay, whereas clopidogrel naïve subjects will be~     guided by Verigene CYP2C19 genotyping assay. Patients on clopidogrel maintenance and/or in~     the control group will also be genotyped; conversely, clopidogrel naïve subjects will have~     VerifyNow testing prior to discharge for additional study analysis. Patients in the guided~     therapy group that have a measurement of ≥ 230 PRU will be reloaded with 60mg prasugrel and~     receive standard maintenance dosing. Similarly, clopidogrel naïve subjects that are~     considered CYP2C19*2 carriers will also be reloaded with 60mg prasugrel and receive standard~     maintenance dosing (see flow schematic). Patients randomized to the control arm will remain~     on 75mg clopidogrel arm throughout the study. All patients will remain on 325mg ASA for one~     month and 81-162 mg daily ASA thereafter.~      Clinical follow-up (office visit) and post-PCI VerifyNow maintenance testing will occur at 2~     weeks, 3 months, and 6 months for patients in the guided therapy group. VerifyNow testing,~     adverse event occurrence and drug compliance will be performed as part of follow-up.~     Patients having a measurement of ≥ 230 PRU at 2 weeks or the 3 month visit will be reloaded~     with 60 mg prasugrel and receive standard maintenance dosing thereafter until the 6-month~     visit. Patients in guided and control study arms will return at 6 months for clinical~     follow-up and VerifyNow testing. After completing 6 months of the study treatment period,~     further antiplatelet therapy will be at the physician's discretion. At 1 year, study~     subjects will be contacted via phone for clinical assessment and antiplatelet compliance.~     Physicians adjudicating events will be blinded to the therapy assignment.~   "
143416|NCT01177579|"~     Copper is an essential nutrient for humans and is cofactor in enzymes that participate in~     critical body functions. Insufficient copper can lead to hematological and neurological~     abnormalities that may be irreversible if left untreated. Copper deficiency is believed to~     be rare in the U.S. population because typical dietary intake is usually sufficient to meet~     requirements. More recent evidence suggests that specific populations may be susceptible to~     copper deficiency in cases where copper absorption in the gut is impaired following gastric~     surgery or in individuals with high intakes of zinc. Preliminary studies by us and others~     have identified significant levels of moderate and severe symptomatic copper deficiency in~     patients who have undergone weight loss (bariatric) gastric bypass surgery. Copper~     deficiency in humans is difficult to recognize and treat because current diagnostic tools~     rely on measures of plasma concentrations of copper and ceruloplasmin, which are neither~     sensitive nor specific for copper deficiency, and early warning blood markers (biomarkers)~     have not been identified. Recent developments indicate that copper chaperone molecules and~     cuproenzymes such as cytochrome C oxidase and superoxide dismutase may be more sensitive to~     changes in copper status, but there has been very little work done in humans. The studies~     outlined here are aimed at assessing copper status using these biomarkers in gastric bypass~     surgery patients who are at risk for symptomatic copper deficiency. In addition, patients~     identified to be deficient will be supplemented with copper and this treatment will be~     evaluated using biomarker concentrations. The findings of these studies should provide~     insight into the effectiveness of novel biomarkers to identify those at risk and to guide~     appropriate treatment to prevent serious and permanent morbidity due to copper deficiency.~   "
143417|NCT01177566|"~     The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1%~     (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic~     dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target~     area located on one side of the body, and apply the medical device cream three times daily~     for four weeks on the opposite side of the body at a target lesion symmetric to the other.~   "
143418|NCT01177553|"~     Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton~     pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic~     twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous~     demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or~     severe neurologic handicap (up to 30% risk) of the other twin. These complications result~     from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin~     through placental vascular communications.~      Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are~     mediated through placental vascular anastomoses, we have proposed obliterating such~     anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to~     identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV~     communications are identified on the surface of the placenta by noting that the terminal end~     of the artery of one of the fetuses does not have a corresponding returning vein to the same~     fetus. We have speculated that the separation of the circulations may be of benefit in~     monochorionic twins affected by SIUGR by preventing the adverse effects that may result from~     the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical~     trial the outcome of SIUGR managed either expectantly or with SLPCV.~      Study procedures will begin with confirmation of the diagnosis and screening criteria at the~     Qualified Clinical Center. The patient will sign the appropriate consents and then be~     randomized to her treatment group. Enrollment data will be submitted to the research~     coordinator in Coordinating Center in Tampa. Expectant management patients will be treated~     by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa~     General Hospital or qualified laser center. They may return to the referring center for~     follow-up. After delivery, outcome data will be sent to the research coordinator in~     Coordinating Center in Tampa.~   "
143419|NCT01177540|"~     The purpose of this study is to provide data on the activity of a standard daunorubicin,~     cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as~     assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and~     overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide~     necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients~     that is currently unavailable.~   "
143420|NCT01177527|"~     The purpose of this study is to obtain bone marrow and peripheral blood samples, along with~     clinical data from patients with Multiple Myeloma (MM), Waldenstrom's Macroglobulinemia~     (WM), Smoldering MM, and other lymphoplasmacytic lymphomas (LPL) including but not limited~     to MGUS and IgG or IgA LPL. These samples will become part of a tissue bank and will be used~     in ongoing studies to find out more about the causes and biology of MM, WM and LPL; to~     identify what factors result in normal cells becoming cancer; to determine how to improve~     treatment options; to study how the immune system identifies abnormal cells; and to evaluate~     the immune function in these diseases. The investigators will also study the tumor cells at~     the level of the participant's genes to develop treatment strategies as well as to better~     understand how biologic differences affect patient outcomes.~   "
143421|NCT01177514|"~     The primary aims of this study are to determine if treatment with Gabapentin taken~     systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical~     treatments reduces post surgical neuropathic pain and discomfort. The investigators main~     Hypothesis is that gabapentin given prior to and after refractive surgery prevents central~     sensitization and local allodynia.~   "
143423|NCT01177488|"~     The purpose of this study is to determine whether therapy for Operation Iraqi~     Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder~     (PTSD) symptoms can be delivered effectively using videoconferencing technology~     (telepsychology), which allows a therapist and patient who are not in the same room as one~     another to communicate.~   "
143424|NCT01177475|"~     It seems important to correlate real consumption in bioactives molecules of natural milk~     versus pasteurized with gut maturation in very preterm infants during small enteral feeding~     protocol. This objective will be reached through a clinical trial.~   "
143425|NCT01177462|"~     Manipulation of object is a multisensory experience that includes tactile motion between the~     object and the fingerpad, visual motion elicited by the motion the object and the movement~     of the hand, and the active motor commend to control upper limb and hand conformation. It~     remains to be determined how such a complex interaction between touch and vision could be~     achieved effortlessly. In the present study, we will investigate how the motion information~     is transformed between touch and vision using the most novel approaches in human~     psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present~     tactile motion on primate fingerpads using a recently developed ball stimulator with a~     design in which we vary the direction of motion with respect to the skin surface and also~     vary the hand conformation and position. This setup allows us to systematically sample the~     possible scenarios involving coordinate transformation between the somatosensory and visual~     systems in conditions that could occur in hand exploration and object manipulation in daily~     life. We will present these tactile stimuli on normal human subject as well as stroke~     patients such as patients with spatial hemineglect. Finally, we will record from macaque~     monkeys in cortical areas that are thought to underlie the transformation of coordinates,~     such as the primary somatosensory cortex and posterior parietal cortex. The results of the~     present study will contribute to the understanding of multisensory integration and the~     rehabilitation for patients with impaired use of spatial information.~   "
143426|NCT01177449|"~     The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar~     flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on~     balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits~     of stability (LOS.)~   "
143427|NCT01177436|"~     Nowadays, prostate cancer screening is largely widespread although it is not recommended~     yet. This screening includes primarily digital rectal examination and PSA.~      Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3~     gene.~      The main objective is to evaluate prospectively this new marker in patients treated for~     prostatic pathology (benign or malign) in the department.~   "
143428|NCT01177423|"~     Management of dental pain emergencies is a challenge for the clinician, particularly when~     pain is due to endodontic infection.~      Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior~     alveolar nerve block for mandibular molars anesthesia.~      The aim of the study is the evaluation of Quicksleeper efficiency used in first intention~     versus inferior alveolar nerve block used in most current dental treatment.~   "
143429|NCT01177410|"~     The purpose of this study is to determine the daily dose of mesalamine granules that will~     provide adequate relief from symptoms of IBS with diarrhea.~   "
143430|NCT01177397|"~     The main purpose of this first human study with CC-223 is to assess the safety and action of~     a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors~     unresponsive to standard therapies and to determine the appropriate dose and tumor type for~     later-stage clinical trials.~   "
143431|NCT01177384|"~     This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C)~     more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a~     steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg~     once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM~     with inadequate glycemic control on acarbose monotherapy.~   "
143432|NCT01177371|"~     RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide,~     before a donor bone marrow transplant helps stop the growth of cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy~     stem cells from a donor are infused into the patient they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Giving cyclosporine, methylprednisolone, and methotrexate after transplant may stop this~     from happening.~      PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide~     followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic~     syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.~   "
143433|NCT01177358|"~     The investigators hypothesize that Botox A will reduce scarring and improve healing of~     surgical neck wounds.~   "
143434|NCT01177345|"~     Cervical cancer screening is a worldwide problem especially in the developing world of which~     Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic~     facilities and resource people. It occurs in the age groups between 40 and above and~     therefore affects the productive age of the community. It is well known that women generally~     are the backbone of every community and specifically in the developing countries.~      The objective of this research is to analyze and quantify the burden of cervical cancer~     disease in the community. It will research the interpersonal and socioeconomic issues~     associated with cervical cancer disease in the family.~   "
143435|NCT01177332|"~     There is increasing evidence that hepatic lipid content (IntraHepatic Lipid, IHL) markedly~     increases the risk of metabolic complications, including insulin resistance and~     cardiovascular events. The investigators hypothesize that the liver is passively taking up~     free fatty acids (FFA) when the availability is high, thereby leading to an increased~     storage. To test this hypothesis, the investigators want to manipulate FFA levels, by means~     of a fasted exercise and recovery protocol, and monitor IHL content and hepatic Adenosine~     triphosphate (ATP) and inorganic phosphate (Pi) concentrations.~   "
143436|NCT01177319|"~     This is an investigator initiated pilot study to examine the effects of GSH in PD. The goal~     of this study is to acquire some basic data regarding side effects and efficacy of this~     compound to determine if this is a possible treatment option that could be recommended to~     interested PD patients.~   "
143437|NCT01177306|"~     Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release~     guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using~     a standardized battery of tests for effect on symptoms of ADHD and working memory will be~     administered and assessed.~   "
143438|NCT01177293|"~     This study is being performed to determine the bioavailability, or extent of absorption into~     the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to~     the bioavailability of a 10 mg amlodipine besylate capsule.~   "
143442|NCT01177241|"~     Using a retrospective analysis of a large commercial claims database and a Medicare~     database, the investigators evaluated DDEs that have the potential to cause DDIs among~     chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes~     through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s)~   "
143443|NCT01177072|"~     1. That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is~          effective in reducing the severity of mental health symptoms experienced by torture~          survivors in Southern Iraq.~        2. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is~          effective in reducing the severity of mental health symptoms experienced by torture~          survivors in Southern Iraq.~   "
143444|NCT01177059|"~     The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency~     Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1~     Ribozyme [OZ1]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5~     years from initial infusion of study drug has elapsed and then yearly for the rest of their~     lives. The study will monitor for and record any ill effects from the gene therapy product~     to provide long term safety information.~   "
143445|NCT01177046|"~     The findings of this research will be used to develop a scale for measuring the quality of~     epidural pain relief achieved during labour and vaginal delivery.~   "
143446|NCT01177033|"~     CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS~      Phase: IV~      TITLE OF STUDY~      Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised~     controlled trial for patients with complex lesions of the superficial femoral artery~      CONDITION~      Peripheral arterial occlusive disease (PAOD)~      OBJECTIVE(S)~      The objective of this study is to evaluate the safety and efficacy of two therapeutic~     strategies (operative versus endovascular) in the treatment of patients with complex~     atherosclerotic lesions of the superficial femoral artery.~      INTERVENTIONS~      Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention~     type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous~     vein (1° choice) or a prosthetic graft (if vein is not available).~      Duration of intervention per patient: Dependent on the method of treatment~      Follow-up per patient: 24 months~      OUTCOMES~      Primary efficacy endpoint:~      Two primary efficacy endpoints will be considered simultaneously in this trial:~      (A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of~     surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford~     classification) without the need for repeated target lesion revascularization (TLR).~      (B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford~     classification) at 24 months after primary intervention (regardless any performed~     re-intervention).~   "
143447|NCT01177020|"~     Identification of the presence of proangiogenic immune cells in normal human placentas may~     enable predication of some pregnancy disorders.~   "
143448|NCT01177007|"~     This study is an open label prospective trial of TheraSphere treatment for patients who have~     liver metastases who have failed or are intolerant to other systemic or liver directed~     therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then~     followed for time to progression (TTP), safety, and overall survival.~   "
143449|NCT01176994|"~     Existing methods of diagnosing and treating skin lesions are either surgical, which enables~     an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser,~     caustics) with no possibility of obtaining histology. The ingredients of current~     formulations for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for~     application and painful - therefore their use was abandoned. The investigators will examine~     the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions~     .These formulations were safe and had a rapid onset of fixation effect in in-vivo animal~     studies.~   "
143450|NCT01176981|"~     The primary purpose of this study is to determine the safety and feasibility of delivering~     HDMTX in an outpatient setting.~   "
143451|NCT01176968|"~     Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction,~     in patients without heart failure, reduces cardiovascular mortality / morbidity.~   "
143452|NCT01176955|"~     This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with~     mild to moderate acne. Study subjects will be randomized to an internet survey group, in~     which an email link for a survey ascertaining the status of the subject's acne is sent~     weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and~     adherence and clinical improvement will be monitored over 12 weeks. The investigators~     hypothesis is that subjects in the internet survey group will have improved adherence to the~     study medication and clinical outcomes, because the weekly survey will remind subjects to~     use their medication.~   "
143453|NCT01176942|"~     The purpose of this study is to determine whether probiotic treatment of overweight~     volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide~     concentration.~   "
143454|NCT01176929|"~     The prevention of recurrent suicidal about people who have made a suicide attempt is a major~     strand in the prevention of suicide. It is estimated that 10-15 % of people who made a~     suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the~     subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 %~     at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this~     population, there is a low adherence to care.~      The main objective of the study is to test the effectiveness of a prevention program of~     recurrent suicidal acts for people who made a suicide attempt.~      The secondary objectives of this study are the assessment of adherence to care; the~     identification of sub - populations benefiting most from this program; the evaluation of the~     possible generalization level of the program (eligibles persons rate) and its feasibility~     level.~   "
143480|NCT01176591|"~     The proposed research will focus on investigating the determinants and consequences of CAD~     via measurement of physiological, behavioral and subjective effects of physiologic and~     psychologic stress cues in CAD volunteers in the laboratory, and through examination of the~     effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study~     will examine the effects of the above stress cues on cocaine and alcohol craving under acute~     Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover~     design using 24 subjects.~   "
143455|NCT01176916|"~     Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women~     with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3~     years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive~     years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with~     clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast~     cancer since then, there is currently lack of systematic collection and analysis for the~     efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin®~     Non-Interventional Study is being proposed to collect data systematically and to assess the~     efficacy and safety of Aromasin® adjuvant setting in Chinese population.~   "
143456|NCT01176903|"~     The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as~     pMDI after single and repeated administration.~   "
143457|NCT01176890|"~     The aim of this study is to investigate the role of transmission via the vagal nerve for the~     effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food~     intake.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the researchers will investigate individuals with and without~     intact nervous supply.~   "
143458|NCT01176877|"~     The purpose of this study is:~        -  to identify how knowledge about keloid scars and self-treatments differs between~          patients who use the Internet as a source of information and patients who do not~        -  to determine if patients who are at a high risk of developing additional keloid scars~          are more or less likely to change their behavior based on an educational information~          talk about keloid scar prevention~   "
143459|NCT01176864|"~     Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic~     small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the~     technique. A prospective randomized study was carried out to compare the two methods in~     obscure small bowel bleeding~   "
143460|NCT01176851|"~     The purpose of this study is to investigate the pharmacokinetics, the absolute~     bioavailability and the lung bioavailability of inhaled Glyco pMDI.~   "
143461|NCT01176838|"~     The purpose of this study is to provide the physicians with quality long term follow up data~     on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly~     diagnosed with breast cancer and will receive treatment for the cancer at this facility.~     Over the last two decades many studies have been done concerning the quality of life after a~     mastectomy and/or reconstruction process. The majority of these studies only run for one~     year post reconstruction, some however, do include a two year follow up. The investigators~     are proposing a 5 year long term follow up study on subjects who will be diagnosed and~     treated here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators~     first questionnaire will be given prior to any treatment for breast cancer, giving us a~     baseline for the subject's current quality of life. At each successive year, the subject~     will be given another questionnaire with regards to their progression through the~     reconstructive process. At the end of 5 years, the subject will complete a final~     questionnaire. These questionnaires will deal with many areas of daily life functions;~     activities of daily living, anxiety, depression, social interactions, personal and sexual~     relationships.~   "
143462|NCT01176825|"~     The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention~     for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on~     improving management of bipolar disorder, reducing involvement in high-risk behaviors, and~     enhancing psychosocial functioning. The intervention also focuses on issues specific to~     transition-age youth. The study includes two phases: In phase 1, the intervention will be~     developed, refined, and openly piloted with several participants. In phase 2,the~     investigators will conduct a randomized clinical trial, in which 40 participants will be~     randomized either to receive the intervention right away, or to a 14-week waitlist~     condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the~     study period, as well as at 3- and 6-month follow up, using measures of mood symptoms,~     high-risk behaviors, drug and alcohol use, and psychosocial functioning.~   "
143463|NCT01176812|"~     The face is arguably the most critical aesthetic unit of the body. As humans begin to age,~     numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue~     atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and~     changes in bony architecture. These changes are potentiated in our population secondary to~     sun exposure and smoking. To combat the effects of aging on the face, a multitude of~     products and procedures exist to attempt to reverse the effects of sun damage and aging to~     achieve a youthful and rejuvenated appearance. There has been a shift from invasive~     procedures such as a facelift to noninvasive means using filling agents to restore lost~     contour deformities.~      The investigators hypothesis is that the use of dermal filling agents effectively delays the~     need for invasive procedures such as facelifts, and that patient satisfaction has increased~     with the evolution of recent dermal filling agents.~   "
143481|NCT01176578|"~     The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in~     the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant~     impact on the millions of Americans who have T2DM. This project is designed to 1) determine~     the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared~     those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if~     aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether~     improvement in EPC number and function translates to improved endothelial function,~     increased capillarization, and improved glucose metabolism in T2DM.~   "
143490|NCT01176461|"~     This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of~     BMS-936558 in combination with or without a peptide vaccine.~      The purpose of this study is to test the side effects of an investigational vaccine with an~     immune booster. Investigators also wish to find out its effects on the patient's immune~     system and whether it will shrink their melanoma.~   "
143491|NCT01176448|"~     Dermabrasion has been the historical standard used for resurfacing scars on the skin.~     Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study~     intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.~   "
143464|NCT01176799|"~     This is a single-centre, phase II randomized study of doxorubicin and cyclophosphamide (AC)~     with or without intermittent sunitinib in patients with measurable primary breast cancer who~     are receiving pre-operative chemotherapy.~      A lead-in phase I study was built into this protocol to determine the dose and duration of~     sunitinib that may achieve the desired effects of normalizing tumor vasculature prior to~     chemotherapy administration.~      A total of 64 patients with measurable primary tumor will be enrolled for the Phase II part~     of the study. Eligible patients will be randomized 1:1 to either arm A or arm B. Patients~     will be stratified according to metastatic status (metastatic vs non-metastatic) and~     presence or absence of clinical T4 disease.~      Arm A (Control arm):~      Doxorubicin 60mg/m2 day 1 Cyclophosphamide 600mg/m2 day1, every 3 weeks x 4 cycles~      Arm B (Experimental arm):~      Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily (duration and dose as~     determined from the lead-in phase I study) Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days~     15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC (60/600mg/m2); days 15-21 - oral~     sunitinib daily Cycle 3: day 1 - Cycle 3 AC (60/600mg/m2); days 15-21 - oral sunitinib daily~     Cycle 4: day 1 - Cycle 4 AC (60/600mg/m2)~      DCE-MRI scan will be performed serially to determine tumor response and change in tumor~     vascular parameters for each enrolled subject:~      Patient will be evaluated weekly for toxicity assessments and full blood count during cycle~     1, and on days 1 and 15 of each subsequent cycle. In addition, patients in Arm B will be~     evaluated weekly during the first two weeks of sunitinib administration prior to cycle 1 AC.~   "
143465|NCT01176786|"~     This study will look at the rate of infections developed by subjects comparing the use of~     disposable draping systems versus reusable draping systems in the operating room.~   "
143466|NCT01176773|"~     The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra~     Lip Injectable Gel for lip enhancement.~   "
143467|NCT01176760|"~     The aim of this study is to investigate the role of transmission via the vagal nerve for the~     effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.~      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous~     system and for this reason the investigators will research individuals with and without~     intact nervous supply.~   "
143468|NCT01176747|"~     The purpose of this study is to investigate the lung deposition and distribution pattern of~     Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a~     single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the~     NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic~     exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.~   "
143469|NCT01176734|"~     The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the~     afferent branches of the nervus vagus around the human ear. The clinical trial is designed~     as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve~     stimulation.~   "
143470|NCT01176721|"~     Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy~     and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle,~     in schizophrenia.~      Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive~     impairment,and aggressive behavior of treated schizophrenia patients.~   "
143471|NCT01176708|"~     The aim of the study is to investigate the significance of intact nerve supply to the liver~     for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.~      The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and~     that these effects involve sensory afferent neurons, probably primarily parasympathetic.~   "
143472|NCT01176695|"~     The purpose of the study is to compare a fish oil containing lipid emulsion against a~     medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and~     safety during postoperative parenteral nutrition.~   "
143473|NCT01176682|"~     The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis~     and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor~     in usual clinical practice, how patients comply with their treatment and how satisfied they~     are with their treatment.~   "
143474|NCT01176669|"~     The hypothesis of this clinical research study is to discover if the study drug apatinib can~     shrink or slow the growth of pretreated metastatic triple-negative breast cancer.~   "
143475|NCT01176656|"~     The purpose of this study is to assess the burden of hypoglycemia and identify unmet need~     related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on~     OADs and/or insulin. This is an observational study which will identify patients with T2DM~     in an administrative claims database and will link claims data with results of patient and~     physician surveys concerning hypoglycemia.~   "
143476|NCT01176643|"~     The purpose of this study is to test the effects of a modified yoga program in persons with~     SLE.~   "
143477|NCT01176630|"~     The study is a survey to answer the specific question, What is the prevalence of metabolic~     syndrome in maintenance hemodialysis patients? Metabolic syndrome is a cluster of~     conditions that increase an individual's risk for developing cardiovascular disease and~     diabetes.~   "
143478|NCT01176617|"~     The purpose of this study is to determine if continuous monitoring using an implantable loop~     recorder (ie. a device that is placed just underneath the skin of the chest and monitors the~     heart rate and rhythm) for a year long period after atrial fibrillation ablation may be~     superior to the current conventional monitoring strategy used by us for determination of~     atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia~     burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some~     data suggests that continuous monitoring over longer periods may be better in identifying~     recurrence of atrial fibrillation after ablation and thus assist in its overall management.~     The device being used for this study is the Reveal XT, which, is currently FDA approved for~     monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.~   "
143479|NCT01176604|"~     This is not a research study. The goal of this treatment protocol is to learn more about the~     patient experience, including any reported side effects and possible benefit related to the~     use of the TheraSphere device for treatment of liver cancer. Because treatment using the~     TheraSphere device must be designed specifically for each patient, the treatment process~     will also be monitored.~   "
143482|NCT01176565|"~     The specific aims of this study are to:~        1. Definitively determine the therapeutic benefit of the intensive treatment relative to~          the standard treatment in the proportion of patients with death and disability (mRS~          4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom~          onset.~        2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard~          treatment in the subjects' quality of life as measured by EuroQol at 3 months.~        3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard~          treatment in the proportion of hematoma expansion (defined as increase from baseline~          hematoma volume of > 33%) and in the change from baseline peri-hematoma volume at 24~          hours on the serial computed tomographic (CT) scans.~        4. Assess the safety of the intensive treatment relative to the standard treatment in the~          proportion of subjects with treatment-related serious adverse events (SAEs) within 72~          hours.~   "
143483|NCT01176552|"~     This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage~     colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2)~     postoperatively in patients with high-risk renal cell carcinoma (RCC).~   "
143484|NCT01176539|"~     The purpose of this study is to determine whether the respiratory rate provided by Kai~     Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the~     currently used methods, including respiratory chest bands.~   "
143485|NCT01176526|"~     Social comparisons may function as a coping strategy, but their role in coping and quality~     of life has not been well characterized. The purpose of the current study is to investigate~     the relationships between cognitive appraisals; coping strategies; social comparisons; and~     quality of life among men with prostate cancer. The conceptual framework for this study is~     drawn from Festinger s Social Comparison Theory, Lazarus and Folkman s Transactional Model~     of Stress and Coping, and Mishel s Uncertainty in Illness Theory. A cancer diagnosis is~     accompanied by uncertainty about how cancer will affect one s life. Theory and empirical~     data suggest that in conditions of uncertainty, coping affects adjustment to a condition.~     Social comparisons have been postulated to be more prevalent in uncertain situations.~     Because little is known about how social comparisons operate, participants in this study~     will be recruited exclusively from prostate cancer support groups. Support groups provide a~     context in which individuals are likely to make social comparisons and to be cognizant of~     these comparisons. Prostate cancer provides a model of a common, chronic condition with~     complex etiology. Prostate cancer treatment may cause sexual, urinary, and bowel side~     effects, which may affect patients quality of life and elicit attempts to cope. One way of~     managing the prostate cancer experience may be to compare oneself to others who are doing~     better or worse than oneself on relevant dimensions. The interpretation of social~     comparisons may positively or negatively affect one s perceived quality of life. There have~     been no studies among prostate cancer patients that have quantitatively measured the use of~     social comparisons. There is also a paucity of research in this population regarding the~     predictors of coping strategies and the predictors of quality of life across multiple~     domains. This study will use a cross-sectional, mixed methods survey to investigate~     relationships between cognitive appraisals, coping, and quality of life and to qualitatively~     explore social comparisons among men with prostate cancer. Participants may complete the~     survey on paper or online. The primary outcomes are the use of coping strategies, including~     social comparisons, and quality of life. Individuals with a personal or family history of~     prostate cancer are currently seen by genetic counselors as part of research studies~     investigating the genetic basis of prostate cancer. If relationships are demonstrated~     between the social comparisons and quality of life, genetic counselors may want to assess~     patients social comparisons to evaluate how patients are coping with their condition.~   "
143486|NCT01176513|"~     Background:~      - GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells.~     Researchers are interested in combining the drug with a small amount of radioactive material~     to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are~     also interested in determining whether the combination can help make cancer cells in pelvic~     lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine~     individuals who are scheduled to have surgery on their prostate cancer.~      Objectives:~      - To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer~     cells in pelvic lymph nodes using positron emission tomography and magnetic resonance~     imaging scanning.~      Eligibility:~      - Men at least 18 years of age who have been diagnosed with prostate cancer and are~     scheduled to have prostate removal surgery.~      Design:~        -  Participants will be screened with a physical examination, medical history, blood~          tests, and imaging studies.~        -  Participants will have magnetic resonance imaging (MRI) and positron emission~          tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and~          PET scans may be performed on the same day or on different days, depending on the~          schedule set by the study researchers.~        -  Tissue samples taken during prostate removal surgery, including prostate tissue and~          pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148~          (18F).~   "
143487|NCT01176500|"~     Background:~        -  Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which~          preferentially binds with high affinity to alpha(v)beta(3) integrins, which are~          up-regulated in and may regulate angiogenesis.~        -  [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging~        -  Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of~          patients with targeted antiangiogenic drugs~      Objectives:~      Primary~        -  To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle~          of treatment with targeted anti-angiogenic therapy~        -  Secondary~        -  To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F]~          Injection in subjects with solid tumors~        -  To obtain preliminary data on the relationships between [18F]fluciclatide as a~          pharmacodynamic marker and standard of care imaging markers of clinical response (e.g.~          contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET),~          obtained as part of routine clinical follow-up as specified in the referring protocols,~          as well as any optional imaging performed~      Eligibility:~        -  Patients greater than or equal to 18 years, with documented malignancy, and solid tumor~          greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an~          NCI therapy protocol using one of the anti-angiogenic agents described in the full~          protocol~        -  Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL,~          prothrombin time (PT) and aPTT less than 2 times normal limits.~        -  The subject has not received any targeted anti-angiogenic agents within 60 days prior~          to pre-treatment (baseline) [18F]fluciclatide administration~      Design:~      This study is intended to obtain preliminary data on the uptake and retention of~     [18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of~     the imaging protocol, identification of the most relevant imaging parameters, and allow for~     calculation of the number patients required to power a larger study to assess the utility of~     PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted~     anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center~     study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one~     pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early~     post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed.~     The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies~     will be evaluated to determine if there is a measureable difference in uptake. Data from the~     subject's referring therapy protocol will be reviewed for up to one year. An optional~     DCE-MRI scans of the target lesion may also be performed.~   "
143488|NCT01176487|"~     RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by~     palliative radiation therapy and improve the quality of life of patients with lung cancer.~      PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy~     works in reducing the side effects of palliative radiation in patients with lung cancer.~   "
143489|NCT01176474|"~     The purpose of this study is to test the side effects of an investigational vaccine with an~     immune booster, or 2 different boosters together. Investigators also want to find out its~     effects on the immune system and whether it will decrease the chance that melanoma will~     return.~   "
143524|NCT01176019|"~     The purpose of this study is to determine whether an interactive education program for~     prenatal testing is effective in improving pregnant women's understanding of and~     expectations towards prenatal screening and diagnosis.~   "
143492|NCT01176435|"~     This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized,~     placebo-controlled, double-masked clinical trial to see if vision can be improved in~     individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these~     individuals may increase melanin pigment production. Increased melanin has previously been~     shown to be associated with improved vision.~   "
143493|NCT01176422|"~     Researchers hope to determine if the DNA is shortened in your body and determine if there is~     an increase in the protein that shortens DNA called telomerase.~   "
143494|NCT01176409|"~     The purpose of this study is to compare the levels of immune and inflammatory markers among~     HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL,~     between those randomized to valacyclovir and placebo, over a twelve-week intervention~     period.~   "
143495|NCT01176396|"~     The goal of this project is to create a Practice Based Research Network with 30 researcher~     dentists calibrated on the administration of a caries risk assessment and the treatment~     modalities recommended based on the caries risk assessment results (Caries Management by~     Risk Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices.~     Participating dentists will be a mix of general practitioners and pediatric dentists~     selected from private practice, part time university faculty, large group practices, or~     community clinics. Participating practices will collect baseline data and patient progress~     and report on patient acceptance and compliance, and the effectiveness of treatment.~      The program's duration is anticipated to be approximately four years. Year one will be~     dedicated to program, protocol and evaluation design, and recruitment, selection and~     calibration of researcher dentists. Years two and three will be the research and data~     collection time period, and year four will be dedicated to evaluation.~   "
143496|NCT01176383|"~     Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of~     Biological Sciences, University of Auckland) and his team have developed a reliable genetic~     test Respiragene based on 20 single nucleotide polymorphisms that can be used (together~     with details of personal and family history) to calculate a smoker's lifetime risk of~     developing lung cancer. The expectation is that whatever the score (estimated lifetime risk~     will vary from 5% to 50%) the result will counter optimism bias of the smoker and~     encourage smoking cessation and this assumption is supported by previous research on similar~     tests and smoking cessation. The investigators plan to recruit two groups of subjects for~     smoking cessation but only one group will have the Respiragene test. Eight weekly smoking~     cessation sessions will be carried out at a Surrey primary care medical centre and will~     follow the usual format for National Health Service smoking cessation clinics using Champix~     (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation~     questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of~     nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks~     and six months after the completion of the seven smoking cessation sessions. Successful~     smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six~     months and questionnaires will be used to estimate the influence of the Respiragene test~     compared with standard procedures such as counselling and the carbon monoxide breath~     readings.~   "
143497|NCT01176370|"~     The C-Pulse Study is evaluating the safety and performance of a new product for the~     treatment of heart failure. The product is designed to help reduce the symptoms of heart~     failure and help patients function better with daily activities. The study evaluates~     multiple measures of heart function and whether the patient's quality of life has been~     improved since the device implant. The patient will have several visits after the device~     implant to assess how well they are doing and to monitor any safety concerns.~   "
143498|NCT01176357|"~     Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening~     of the arteries, or atherosclerosis that is an inflammatory process in which immune~     mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions~     in the arterial trees. Epidemiological studies have found that increased cardiovascular~     risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6~     [IL-6] and tumor necrosis factor-alpha[TNF-alpha]) or their hepatic product, C-reactive~     protein (CRP). Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic~     protein-1 (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients~     with CAD. These findings suggested that the pericoronary tissues could be a source of~     inflammatory mediators or act as paracrine that lead to vascular inflammation on CAD~     pathogenesis. However, adiponectin, a kind of adipocytokine, produced and secreted~     exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory~     functions against atherosclerosis, resulting in risk reduction for incidence of CAD events.~     It remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose~     tissue contribute to CAD. We therefore aim to analyze the expression of adiponectin and~     inflammatory mediators in mediastinal adipose tissue between patients with CAD and with~     valve diseases, and to correlate these parameters with clinical atherosclerotic risks,~     medications (statins or antiplatelet), and blood sugar.~   "
143499|NCT01176344|"~     Observational evidence suggests that vitamin D deficiency may have a role in the causes of~     osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There~     is, however, no evidence which shows that intervening with vitamin D supplementation can~     slow the progression of OA. This study is to determine if vitamin D supplementation can~     reduce knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use~     of MRI will provide sensitive measures of knee OA changes.~   "
143500|NCT01176331|"~     In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was~     performed in 21 eyes for various indications and proposed as a transition procedure to~     23-gauge transconjunctival vitrectomy. Through use of combination of procedures~     postoperative complications, surgical trauma and healing time was decreased; operating time~     was reduced; costs were decreased.~   "
143536|NCT01175863|"~     This study is a prospective, randomized, multi-center, open label trial to compare the~     clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional~     Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate~     coronary artery lesion.~   "
143804|NCT01172340|"~     The purpose is to determine if a culturally tailored diet and exercise intervention of 16~     weekly sessions with 8 weeks of followup phone support is effective in reducing waist~     circumference, weight, and related diet and exercise behaviors among women from underserved~     communities.~   "
143501|NCT01176318|"~     This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.~      60 patients to be included who are adult patients admitted to hospital with a clinical~     diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute~     exacerbation of COPD will be defined as sustained worsening of the patient's condition with~     an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence,~     necessitating a change in regular medication.~      The primary objective of this study is to evaluate the effectiveness of standard care plus~     erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder)~     measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus~     placebo.~   "
143502|NCT01176305|"~     The purpose of this study is to describe the incidence of thromboembolic events in relation~     to pregnancy and when in pregnancy and the puerperal period.~   "
143503|NCT01176292|"~     The goal of this study is to determine if the rotating platform high flex design provides~     improved flexion compared to the standard rotating platform TKA.~   "
143504|NCT01176279|"~     The technique of blood samples extraction from the radial artery through an arterial~     catheter with a 3-way stopcock and automated washing with valve of fast flow is better than~     the one carried out through a fixed reusable arterial blood sample syringe and its manual~     washing because it shows a minor incidence of the complications originated from technical~     manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or~     obstruction of the catheter.~      The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood~     samples obtention using an arterial catheter with needless connector closed system or an~     arterial catheter with an arterial blood sample syringe.~      Also a second purpose is to compare once a day (at the same time) the values of glycose~     blood levels between bedside glucometer determination of arterial catheter extraction and~     capillar puncture, and lab determination of glycose from venous puncture, in order to~     determinate fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive~     drugs received by these in-intensive care unit patients.~   "
143505|NCT01176266|"~     This clinical trial is being conducted to study hypophosphatasia (HPP), a bone disorder~     caused by gene mutations or changes. These gene mutations cause low levels of an enzyme~     needed to harden bone. The purpose of this study is to test the safety and efficacy of a~     study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate~     fusion protein) to see what effects it has on patients ≤ 5 years of age or less with HPP.~   "
143506|NCT01176253|"~     To investigate the use of methylation-specific PCR (MSP) assays to detect human beta~     cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed~     Type 1 diabetics.~   "
143507|NCT01176240|"~     This is a study to evaluate the effects of an investigational drug, Droxidopa, in~     participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's~     disease. Droxidopa is being studied to determine the effects on blood pressure changes upon~     standing up (orthostatic challenge). Symptoms and activity measurements, including patient~     reported falls, will be evaluated to determine the effectiveness of the study drug.~      Symptoms of NOH may include any of the following:~        -  Dizziness, light-headedness, feeling faint or feeling like you may blackout~        -  Problems with vision (blurring, seeing spots, tunnel vision, etc.)~        -  Weakness~        -  Fatigue~        -  Trouble concentrating~        -  Head & neck discomfort (the coat hanger syndrome)~        -  Difficulty standing for a short time or a long time~        -  Trouble walking for a short time or a long time~      The study duration is a maximum of approximately 14 weeks including up to 2 weeks for~     screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and~     a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow~     approximately 211 randomized patients. An extension study is also available to continue~     treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored~     by Chelsea Therapeutics and is enrolling by invitation only.~   "
143508|NCT01176227|"~     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable~     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring~     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is~     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and~     bloating.~      The medicines that are currently used to help people with IBS are not as effective as we~     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS~     and not actually treat the disorder itself. Recently, scientists have found that probiotics~     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and~     diarrhea that are part of IBS.~      This research is being conducted to determine whether this particular combination of three~     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium~     longum) will reduce the symptoms of IBS.~   "
143509|NCT01176214|"~     Background:~      One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all~     ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require~     tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma~     volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive~     hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).~      Sustained restricted vigilance and impaired consciousness after ICH is likely to result in~     failure of extubation, raise in incidence of ventilator-associated pneumonia, increased~     amount of sedative drugs and prolonged duration of neurocritical care.~      Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical~     ventilation.~      Basic hypothesis:~      Compared to patients with conventional (late) tracheostomy between day 12 - 14, patients~     with early tracheostomy within 72h after admission will have:~        -  shorter cumulative time of mechanical ventilation~        -  less incidence of ventilator-associated pneumonia~        -  less consumption of sedative drugs~        -  shorter duration of stay in neurocritical care unit~      Randomization:~      Consecutive eligible patients are randomly assigned to Either early tracheostomy within~     72h after hospital admission Or late tracheostomy (= control group; undergoing~     conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive~     plastic tracheostomy~   "
143510|NCT01176201|"~     This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and~     Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.~   "
143511|NCT01176188|"~     Children who become critically ill and require Pediatric Intensive Care Unit~     (PICU)hospitalization may develop negative psychological outcomes following discharge. This~     pilot study will test a nursing intervention that seeks to promote child comfort, sleep and~     psychological well-being during and following PICU hospitalization.~      Study objectives are to:~        1. test the feasibility and acceptability of a PICU comfort care intervention that can be~          administered by nursing staff~        2. examine the feasibility and acceptability of data collection procedures~        3. pilot test outcome measures~        4. determine effect sizes to inform sample size calculation for a future multi-centred~          randomized controlled trial (RCT).~      The intervention will take place in the PICU, and consists of a parental soothing activity~     followed by a quiet period in which earmuffs are placed over the child's ears to block~     noise. Children's sleep time and comfort level will be monitored in the PICU, and the~     investigators will follow them for 3 months post-discharge to examine the effects of the~     intervention on psychological well-being.~   "
143512|NCT01176175|"~     Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the~     minimum effective dose of progesterone microspheres suspension, which administered by weekly~     intramuscular injection, will be able to induce transformation from a proliferative~     endometrium to a secretory endometrium.~      Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.~      Sites: 1 Subjects: 48 postmenopausal women.~   "
143513|NCT01176162|"~     In the neonatal period, the human kidney is characterized by a functional immaturity~     responsible for an impaired ability to regulate water and sodium homeostasis, which is~     exacerbated by prematurity. This altered sodium handling could be related to a partial renal~     aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly~     controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The~     investigators have analyzed MR expression throughout human and mouse renal development, and~     the investigators found a weak MR expression at birth. The investigators have conducted a~     pilot study in full-term newborns, which confirmed a partial neonatal aldosterone~     resistance. This study also highlighted that urinary aldosterone is the best index to~     accurately assess aldosterone sensitivity at birth.~   "
143514|NCT01176149|"~     The aim of this pilot study is to evaluate the validity and feasibility of an educational~     approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely~     changes in therapy, when needed.~   "
143515|NCT01176136|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed~     childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several~     of the primary symptoms of ADHD relate to problems with temporal and materials organization~     (i.e. often has difficulty organizing tasks and activities, often loses things, is often~     forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the~     school setting, problems with organization manifest as forgetting to complete or losing~     homework assignments, difficulties planning for the completion of long-term projects and~     studying for tests, and problems keeping class materials organized. These organizational~     difficulties become particularly problematic in middle school and can result in considerable~     academic impairment (Evans, Serpell, & White, 2005). Children with ADHD underachieve~     academically and are more likely than their peers to receive failing grades, be retained and~     to drop out of school (Barkley, Fischer, Edelbrock, & Smallish, 1990).~      Given the relationship between temporal and materials organization and poor school~     performance, it is clear there is a need for interventions to address these difficulties. We~     recently sought to address this need by completing a small randomized trial of an~     organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz,~     Simon, & Graham, (2008). The intervention was highly effective in improving materials~     organization and homework management and resulted in significant improvements in homework~     problems and grade point average. These results demonstrate the considerable promise of~     organizational skills interventions for children with ADHD. However, the Langberg et al.~     intervention was implemented as an after-school program operated by research staff with~     minimal involvement from school personnel. In order to promote the widespread adoption of~     interventions that address the organizational skills deficits of children with ADHD, the~     intervention must be feasible for school counselors and psychologists to implement within~     the time constraints of a typical school day. Accordingly, the primary goal of this study is~     to adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a~     product that is highly acceptable to parents, children, teachers, school counselors and~     school psychologists and is feasible for school personnel to implement during the school~     day.~      In Phase I of the proposed research, middle school counselors, psychologists, teachers,~     middle school students with ADHD and their parents will consult with the intervention~     developers to modify the after-school treatment protocol for in-school implementation. An~     intervention protocol will be developed. The intervention will be piloted with ten children~     in order to identify barriers to implementation. Measures of treatment fidelity, skills~     acquisition, and satisfaction will be completed. These data will inform additional~     modifications of the protocol and further improve feasibility/acceptability of the~     intervention procedures.~      In Phase II of the study, school counselors/psychologists from at least four separate school~     districts will implement the protocol developed in Phase I. Using a waitlist control design,~     sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational~     skills, grade point average, and academic impairment will be evaluated at baseline, post~     intervention and at 8-week follow-up. After implementing the intervention, all participants~     (i.e., teachers, counselors, psychologists, children and parents) will participate in a~     series of focus groups and will complete intervention satisfaction questionnaires. These~     data will inform final revisions to the intervention protocol. The resulting product will be~     an intervention that targets organizational skills in children with ADHD that has potential~     for widespread school-based dissemination. The final intervention protocol and effect size~     estimates from the proposed research will lay the foundation for an IES Goal III test of~     efficacy.~      The specific aims of the project are as follows:~        1. Utilize the existing organizational skills intervention protocol (Langberg et al. in~          press), focus group and case study data to develop an empirically and clinically~          informed manualized temporal and materials organization intervention for middle school~          children with ADHD aimed at reducing academic impairment (Phase I).~        2. Refine and finalize the intervention protocol through a waitlist control trial (N=60)~          in a minimum of four diverse school districts, collection of clinical outcomes and~          completion of follow-up focus groups to assess satisfaction, feasibility, and~          acceptability (Phase II).~   "
143516|NCT01176123|"~     Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia~     (CBT-I) is important because sleep difficulties often persist after traditional post-trauma~     treatments are completed and other trauma-related symptoms have resolved. The objective of~     this study is to examine whether CBT-I will equivocally reduce problems falling and staying~     asleep (insomnia) related to military-related PTSD when administered in person versus~     through telephone therapy to veterans living in rural areas.~      Rural populations are at a disadvantage in receiving treatment because of lack of access to~     healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance~     counseling to the populations who lack access to health care. Thus, telephone-counseling~     strategies could provide broad access to interventions for management of trauma-related~     insomnia.~      Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will~     be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for~     trauma-related insomnia. Participants will be randomized to one of two treatment conditions:~     (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by~     telephone). No changes will be made to the CBT-I, other than mode of delivery, for the~     telemedicine group.~      Through this study the investigators hope to demonstrate the effectiveness of CBT-I for~     trauma-related insomnia can be delivered effectively to rural veterans in person and via~     telemedicine.~   "
143517|NCT01176110|"~     It is known that perioperative hypothermia can influence the postoperative outcome~     negatively.~      The most important complications are cardiac, increased blood loss with need for transfusion~     and a significantly increased wound infection rate.~      The thermal redistribution after the induction of anesthesia is on of the reasons for~     perioperative hypothermia. Another reason is negative heat balance during surgery.~      Further negative side effects of hypothermia are an increase of blood viscosity and thus a~     higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.~      The aim of the study is to evaluate if patients with a perioperative active thermal~     management during an interventional minimal invasive valve replacement have a significantly~     higher body temperature at the end of the operation than patients without an active thermal~     management. Secondary outcome variables are complication rates, length of mechanical~     ventilation and length of ICU treatment.~   "
143518|NCT01176097|"~     The purpose of this study is to investigate the safety and tolerability of AZD5658 following~     ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated~     dose.~   "
143519|NCT01176084|"~     The purposes of this study are:~      To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of~     heart health including blood fats, blood clotting factors, inflammatory markers and levels~     of body fat.~      To investigate the added effect on heart health that regular moderate exercise may have when~     combined with a low carbohydrate diet in obese men.~   "
143520|NCT01176071|"~     The investigators hypothesize that early galactomannan and beta-D-glucan features, namely~     the height of the initial value at the time of diagnosis and the subsequent rate of marker~     decay within the first week(s) following therapy (day 7, day 14) are important factors in~     predicting clinical outcome.~   "
143521|NCT01176058|"~     In the treatment of patients with candidemia and/or other forms of invasive candidiasis ,~     Anidulafungin is at least as effective and safe as Fluconazole.~   "
143522|NCT01176045|"~     The primary objective of this study is to determine how pre & post-operative tear osmolarity~     levels relate to rates of dry eye symptoms related to refractive surgery and if differences~     exist in patients who are pre-treated with ocular lubricants vs. those treated only~     post-operatively.~   "
143523|NCT01176032|"~     The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels~     of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in~     hypertensive patients.~   "
143525|NCT01176006|"~     Background:~      -DOCK8 deficiency is a genetic disorder that affects the immune system and can lead to~     severe recurrent infections and possible death from infections or certain types of cancers,~     including blood cancers. A stem cell transplant is a life-saving treatment for this~     condition. In this study we are evaluating the efficacy and safety of transplant from~     different donor sources for DOCK8 deficiency. The donors that we are using are matched~     siblings, matched unrelated donors, and half-matched donors, so called haploidentical~     related donors, such as as mothers or fathers or half-matched siblings.~      Objectives:~      -To determine whether transplant of bone marrow cells from different types of donors~     corrects DOCK8 deficiency.~      Eligibility:~        -  Donors: Healthy individuals between 4 and 60 years of age who are matched with a~          recipient.~        -  Recipient: Individuals between 5 and 40 years of age who have DOCK8 deficiency, have~          suffered one or more life-threatening infections, or have had certain viral related~          cancers of cancer and have a stem cell donor.~      Design:~        -  All participants will be screened with a physical examination and medical history.~        -  DONORS:~             -  Donors will donate bone marrow cells or blood stem cells. If donating blood stem~               cells, donors will receive injections of filgrastim to release stem cells into the~               blood. After 5 days of filgrastim injections, donors will have apheresis to donate~               stem cells and white blood cells that are present in the blood.~             -  Donors who provide the stem cells through bone marrow donation will have their~               bone marrow cells harvested in the operating room.~        -  RECIPIENTS:~             -  Recipients receiving matched related or unrelated donors will receive 4 days of~               chemotherapy with busulfan and fludarabine to suppress their immune system and~               prepare them for the transplant. Donors receiving haploidentical related donors~               will receive two doses of chemotherapy with cyclophosphamide, 5 days of~               fludarabine, 3 days of busulfan, and one dose of radiation to suppress their~               immune system and prepare them for the transplant.~             -  After the initial chemotherapy and radiation, recipients will receive the donated~               stem cells as a single infusion. Recipients may also receive white blood cells~               from their stem cell donor to encourage acceptance of the stem cells.~             -  After the stem cell transplant, recipients will receive two days of a chemotherapy~               called cyclophosphamide on day's + 3 and + 4 followed by two drugs tacrolimus and~               mycophenolate to prevent graft versus host disease where the donor cells attack~               the patient's body. All patients will remain in the hospital for approximately 1~               month, and will be followed with regular visits for up to 3 years with periodic~               visits thereafter to evaluate the success of the transplant and any side effects.~   "
143526|NCT01175993|"~     Background:~        -  Traumatic brain injury may have a range of effects, from severe and permanent~          disability to more subtle functional and cognitive deficits that often go undetected~          during initial treatment. To improve treatments and therapies and to provide a uniform~          quality of care, more research is needed into different treatments for traumatic brain~          injury.~        -  Exercise has been shown to improve movement and balance in people with strokes,~          cerebral palsy, and other conditions that affect the brain, and can improve symptoms of~          memory problems or depression. Bright light therapy has also been shown to improve mood~          in people with depression. Researchers are interested in studying problems with~          movement, balance, thinking, and mood in people with traumatic brain injury. By~          comparing the effects of exercise and bright light exposure on brain function, new~          treatments may be developed for acute traumatic brain injury.~      Objectives:~      - To compare the effects of exercise and bright light therapy on the brain function of~     individuals with traumatic brain injury.~      Eligibility:~      - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic~     brain injury or are healthy volunteers.~      Design:~        -  Individuals with traumatic brain injury will have four outpatient evaluation visits at~          the clinical center, a 3-month home exercise program, and a 3-month bright light~          exposure program at home. Healthy volunteers will have one evaluation visit at the~          clinical center.~        -  At the first study visit, all participants will have a full physical examination and~          medical history. Individuals with traumatic brain injury will also have an eye exam to~          determine if it is safe for them to receive light therapy.~        -  All participants will have the following initial tests:~        -  Tests of walking and movement, including monitoring by a physical therapist; tests to~          record joint movement and evaluate muscle function; tests that combine movement,~          thinking, and speaking; and balance and reaction time tests.~        -  Magnetic resonance imaging scans~        -  Tests of thinking and mood, including questionnaires, computerized tests, and simple~          action tests.~        -  Participants with traumatic brain injury will have separate 3-month sessions of~          exercise and bright light therapy, with additional evaluation visits between each~          3-month session and at the end of the study. Between the 3-month sessions, participants~          will have 1 month with no intervention.~        -  Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes~          for 5 days a week, and bright light therapy sessions will involve sitting in front of a~          light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor~          the effects of the therapy.~   "
143527|NCT01175980|"~     This phase II trial studies how well vorinostat works in treating patients with adenoid~     cystic carcinoma that has come back (recurrent) or that has spread from where it started to~     nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body~     (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
143528|NCT01175967|"~     RATIONALE: Measuring changes in performance status and symptoms distress in patients with~     cancer may help doctors predict how patients will respond to treatment, and may help the~     study of cancer in the future.~      PURPOSE: This clinical trial is studying changes in performance status and symptoms distress~     in older patients with advanced ovarian epithelial cancer undergoing surgery and/or~     chemotherapy.~   "
143529|NCT01175954|"~     Primary Objective:~      Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in~     cognitive, mood or quality of life measures.~      To determine the cognitive and behavioral side effects of lacosamide in patients with~     partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test~     battery drawing on tests commonly used and designed to maximize sensitivity to drug effects.~      Secondary Objectives:~      To determine if any significant changes in cognitive, mood or quality of life measures are~     dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide~     dosage.~   "
143530|NCT01175941|"~     This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and~     rectum on parameters affecting the control of defecation in subjects with faecal~     incontinence. The study will investigate the effects of rectal suppositories containing 10~     mg NRL001 given for seven days, once daily. Rectal compliance and median anal resting~     pressure will be considered the primary objective of the study. A pharmacokinetic evaluation~     plus safety and tolerability assessment including monitoring of electrocardiograms (ECGs),~     blood pressure and heart rate will also be evaluated as secondary objectives.~   "
143531|NCT01175928|"~     The purpose of this study is to evaluate the efficacy of the NormaTec PCD, a non-invasive~     pneumatic compression device with the patented peristaltic pulse pneumatic waveform, in the~     treatment of Diabetic Peripheral Neuropathy (DPN).~      The study will compare treatment with a NormaTec PCD and a sham device to assess whether the~     NormaTec PCD improves the signs and symptoms of DPN.~   "
143532|NCT01175915|"~     The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for~     mild type of hand-foot-mouth disease.~   "
143533|NCT01175902|"~     To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared~     to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular~     perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)~      Clinical hypotheses. Primary hypothesis~        -  Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.~      Secondary hypothesis~        -  Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.~   "
143534|NCT01175889|"~     The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the~     E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted~     procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts,~     bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination~     thereof.~   "
143535|NCT01175876|"~     Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia-~     reperfusion injury. As the extent of its effect is unknown, the investigators will use~     clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance~     imaging (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory~     effect.~   "
143537|NCT01175850|"~     The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral®~     drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery,~     as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides~     the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel)~     from the balloon surface into the vessel walls. This drug absorption is intended to limit~     the chances and the entity of artery re-narrowing over time.~   "
143538|NCT01175837|"~     This clinical trial studies short-term fasting before chemotherapy in treating patients with~     cancer. Fasting before chemotherapy may protect normal cells from the side effects of~     chemotherapy.~   "
143539|NCT01175824|"~     The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal~     insulin glargine and once-daily prandial insulin lispro, in participants with Type 2~     Diabetes.~   "
143540|NCT01175811|"~     The purpose of the study is to compare the effects on overall glycaemic control of two~     insulin intensification therapies.~   "
143541|NCT01175798|"~     Dialysis patients often suffer from defects in their immune system (that part of the body~     which fights infection). Evidence suggests that Vitamin D deficiency may have a negative~     effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that~     by giving Vitamin D to dialysis patients who are deficient, we may help improve their immune~     system. This study will test that idea.~   "
143542|NCT01175785|"~     This phase II trial is studying the safety and potential efficacy of infusing non-human~     leukocyte antigen matched ex vivo expanded cord blood progenitors with one or two~     unmanipulated umbilical cord blood units for transplantation following conditioning with~     fludarabine phosphate, cyclophosphamide and total body irradiation, and immunosuppression~     with cyclosporine and mycophenolate mofetil for patients with hematologic malignancies.~     Chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation~     given before an umbilical cord blood transplant stops the growth of leukemia cells and works~     to prevent the patient's immune system from rejecting the donor's stem cells. The healthy~     stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red~     blood cells, white blood cells, and platelets. It may take several weeks for these new blood~     cells to grow. During that period of time, patients are at increased risk for bleeding and~     infection. Faster recovery of white blood cells may decrease the number and severity of~     infections. Studies have shown that counts recover more quickly when more cord blood cells~     are given with the transplant. We have developed a way of growing or expanding the number~     of cord blood cells in the lab so that there are more cells available for transplant. We are~     doing this study to find out whether or not giving these expanded cells along with one or~     two unexpanded cord blood units is safe and if use of expanded cells can decrease the time~     it takes for white blood cells to recover after transplant. We will study the time it takes~     for blood counts to recover, which of the two or three cord blood units makes up the~     patient's new blood system, and how quickly immune system cells return.~   "
143543|NCT01175772|"~     Preclinical studies showed that metronomic chemotherapy can induce tumor regression~     secondary to apoptosis of the tumor blood vessels. This effect was increased by combining~     metronomic chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already~     proved clinical effects too, especially on patients with breast or prostate carcinoma. This~     study is aimed to test the efficacy of an experimental metronomic chemotherapy regimen in a~     cohort of patients with ovarian cancer. Patients will receive the proposed regimen as~     maintenance treatment following response induction by the conventional maximal tolerated~     dose (MTD) regimen of Carboplatin and Paclitaxel. Our regimen will include Cytophosphan~     combined with two agents which are expected to act as indirect angiogenic inhibitors: (a)~     celecoxib, as a selective COX-2 inhibitor and (b) low-dose Methotrexate, as successfully~     practiced for suppressing the inflammatory manifestations of rheumatoid arthritis. All~     components of our regimen will be administered orally and continuously for one year based on~     the hypothesis that its anti-angiogenic properties will be able to suppress the recovery of~     residual disease, thus extending the time to progression (TTP), and possibly the overall~     survival as well.~   "
143544|NCT01175759|"~     The EVE- technology is intended for determination of intolerance or sensitivity to female~     sex hormones among women with hormone-related conditions and for further treatment by~     desensitization procedure inducing a tolerance to the hormones the women are sensitive to.~      This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to~     detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy~     Loss (URPL) and in Control parous, healthy women.~      The Skin Test Panel includes four female hormones and three control solutions.~      Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the~     subject's menstrual cycle. The skin reactions are examined by physician for erythema and~     wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following~     month.~      Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy~     loss (UPRL) and healthy groups.~      Following achievement of the significant differences between both groups the immune profile~     of the healthy and UPRL subjects will be investigated.~   "
143545|NCT01175746|"~     Since nicardipine is known to protect kidney function, nicardipine infusion will result in~     better renal parameters measured in this study.~   "
143546|NCT01175733|"~     The purpose of this study is to investigate whether the addition of panitumumab to~     radiotherapy plus gemcitabine will increase the number of patients who are alive and~     progression free at 7 months.~   "
143547|NCT01175720|"~     The aim of this study is to test a surgical technique for the treatment of gingival~     recessions. The hypothesis of the study is to promote greater root coverage and better~     healing.~   "
143548|NCT01175707|"~     This is a randomized, open-label, multi-center, phase 4 study designed to compare~     intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for~     the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive~     bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning~     to receive vancomycin in a home-infusion setting.~   "
143585|NCT01175226|"~     This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on~        -  shortening the length and reducing the symptoms of human rhinovirus infection (also~          known as the common cold),~        -  controlling asthma symptoms, and~        -  lowering the risk of asthma symptoms worsening in subjects with asthma.~   "
143549|NCT01175694|"~     Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with~     lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a~     highly selected subgroup of patients with low risk invasive carcinoma and low risk duct~     carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of~     pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial~     Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal~     carcinoma in situ concerning local failure (all ipsilateral local recurrences), in~     particular regarding the local recurrences, the toxicity and for the cosmetic result. It is~     a phase II study. According to study protocol altogether 200 female patients will be~     treated.~   "
143550|NCT01175681|"~     Remote ischaemic preconditioning has shown its cardiac protective effect during heart~     surgery including coronary artery bypass graft surgery, congenital heart disease and~     aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart~     disease is one of the major heart diseases requiring surgery in China. Thus, the~     investigators chose heart valve disease as a focus to see whether remote ischaemic~     preconditioning also has cardiac protective effect during heart valve surgery.~   "
143551|NCT01175668|"~     The study plans to compare the use of Clonidine versus Phenobarbital as an additional~     medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug~     withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is~     that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby~     early discharge home.~   "
143552|NCT01175655|"~     The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal~     Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA~     mismatched donors in the management of bronchiolitis obliterans syndrome after lung~     transplantation.~   "
143553|NCT01175642|"~     This randomized trial is examining whether a treatment called cognitive remediation is more~     effective when it is paired with a social and functional skills training component.~   "
143554|NCT01175629|"~     The purpose of The Veteran Health Study (CSP #569) is to better understand the mental and~     physical health of veterans as they get older. We are inviting approximately 10,000 members~     of the Vietnam Era Twin (VET) Registry to participate. As veterans approach their~     mid-sixties, it is important to understand the impact of wartime deployment on health and~     mental health outcomes nearly 40 years later.~      The investigators will assess the prevalence of post-traumatic stress disorder (PTSD) and~     other mental and physical health conditions for Vietnam era veterans, and explore the~     relationship between PTSD and other conditions.~      CSP #569 involves 3 phases of data collection. In Phase I, VET Registry members are invited~     to complete a paper and pencil questionnaire including items on physical and mental health,~     disability, health behaviors, demographic information and use of health care services. After~     completing Phase I, VET Registry members are invited to Phase II which involves a telephone~     interview about mental health. In Phase III, some of those who participated in Phase I will~     be invited to a sub-study confirming self-reported heart disease and diabetes using a~     provider survey.~      Data collected for CSP #569 will be combined with existing VET Registry data. This will~     provide a rich picture of the health of Vietnam era veterans and the influence of PTSD on~     the lives of veterans.~   "
143555|NCT01175616|"~     The purpose of this study is to determine whether creatine will be helpful as an adjunctive~     treatment for treatment-resistant major depressive disorder (MDD) in female and male~     Veterans. We hypothesize that Veterans receiving creatine will show decreased depressive~     symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). We will also~     use 31-Phosphorus Magnetic Resonance Spectroscopy (31-P MRS) brain scans to compare levels~     of neurochemicals related to energy metabolism in the brain, before-and-after treatment with~     creatine, and between healthy controls and MDD participants.~   "
143556|NCT01175603|"~     The goal of this study is to determine whether a 6 week intervention is effective in~     preventing the worsening of depressive symptoms and development of clinical depression in~     low-income African American pregnant and recently delivered women who are enrolled in home~     visiting programs.~   "
143557|NCT01175590|"~     The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic~     suspension, 0.6%) compared to vehicle.~   "
143558|NCT01175577|"~     The primary purpose of this study is to compare the change in blood carotene concentration~     between a food-based versus nutritional supplement-based intervention. This study will~     randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural,~     mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood~     carotene levels will be measured before and after 28 days of supplementation. Preliminary~     data will also be collected on several biomarkers associated with vascular inflammation and~     endothelial dysfunction. These biomarkers will be measured before and during a fast food~     control meal at the beginning and end of the intervention period.~   "
143559|NCT01175564|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics after a~     single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese~     subjects.~   "
143560|NCT01175551|"~     Racism and health care system distrust are potent stressors and may be associated with~     preterm birth (PTB). Additionally, cervical shortening is a common pathway leading to PTB.~     This study is enrolling a prospective cohort of pregnant women. The study assesses racial~     discrimination, health care system distrust, and cervical change using 2 questionnaires,~     exam, and protein levels in cervical vaginal fluid and maternal serum.~   "
143561|NCT01175538|"~     To assess the effects of lactulose for the prevention of first episode of altered sensorium~     (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.~   "
143562|NCT01175525|"~     Mastocytes were proven to have a central rule in their development of the lipoid plaque of~     the vascular system. Mastocytes also has an important role in the stabilisation of the~     plaque in the building of the brain barrier. Different animal studies show that the~     inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding~     post ischaemic stroke.It was also shown that post stroke inflammation process was also~     blocked by the inhibition of mastocytes.Other studies showed up to 100% decrease in the~     brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.~      Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the~     mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used~     in the previously mentioned studies.~   "
143563|NCT01175512|"~     The investigators will develop a measure of endogenous opioid tone that might serve as a~     biological marker for drive for palatable food. Using a 'naltrexone probe,' the~     investigators will assess whether individual response to one dose of an opioid receptor~     antagonist, naltrexone, is related to non-homeostatic eating in non-pregnant women.~      Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.~      Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than~     the 50 mg dose. However, responses will be similarly related to non-homeostatic eating~     measures.~      Hypothesis 3: Response to naltrexone will be highly stable within individuals across time,~     in the absence of an intervention.~   "
143564|NCT01175499|"~     This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic~     evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in~     the study will undergo TNFE-NBI with biopsy of suspicious lesions prior to planned regular~     clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient~     diagnoses and care. As the current standard of care, if all biopsies for a given patient are~     non-malignant, a 3 month office visit will be arranged to evaluate and determine the need~     for further intervention. At the end of study enrollment both sets of biopsies will be~     re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant~     vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree~     on diagnoses.~   "
143565|NCT01175486|"~     Objectives:~      Thiazolidinediones (TZDs) are insulin sensitizers that decrease plasma glucose in type 2~     diabetic patients. Thiazolidinediones can cause fluid retention and peripheral edema in~     diabetic patients, and the systematic fluid retention can be manifested as diabetic macular~     edema (DME). The overall goal of this study is to examine the effects of thiazolidinediones~     on the diabetic retinopathy and nephropathy.~      Study design:~      This is a prospective, randomized, open-labeled, controlled design to assess the effects~     thiozolidinediones on the diabetic retinopathy and nephropathy. The investigators will~     recruit 300 type 2 diabetic patients without significant retinopathy, nephropathy and~     cardiovascular disease. Inclusion criteria are type 2 diabetes, age between 30-80 years old,~     with microabluminuria, no significant retinopathy, on submaximal dose of sulphonylureas and~     metformin treatment, and A1C between 7-9%. Exclusion criteria are on insulin treatment,~     significant retinopathy and significant nephropathy. Patients with cardiovascular diseases,~     malignancy, pregnancy, in acute intercurrent illness, congestive heart failure, myocardial~     infarction, received PCI or CABG. All subjects will receive EKG and CXR before~     randomization.~      These subjects will be randomized equally to 3 groups: acarbose, rosiglitazone and~     pioglitazone. The investigators will follow up for 6 months to investigate the short-term~     effects and 5 years to evaluate the long-term outcomes. The primary study end point of~     short-term study will be the macular thickness changes measured by optical coherence~     tomography, the changes in the level of urinary albumin-to-creatinine ratio, circulating~     metabolic parameters and adipocytokines during thiozolidinediones treatment. Secondary end~     point will be fasting blood glucose, A1C levels, development of clinically significant~     macular edema, serum creatinine change in patients with no history of diabetic retinopathy~     and nephropathy at baseline.~      The primary study end point of long-term study will be the development of clinically~     significant macular edema and the time from the base-line visit to the first detection of~     overt nephropathy. Secondary end points include the development of greater than moderate~     NPDR, the time to the first event of the time from the base-line visit to a doubling of the~     serum creatinine concentration, end-stage renal disease, or death.~   "
143566|NCT01175473|"~     The purpose of the study is to compare the pharmacodynamic effects of lixisenatide~     (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period~     of 4 weeks of treatment.~      The primary objective is to assess the effects of lixisenatide, in comparison to~     liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma~     glucose concentration curve (AUC) after a standardized breakfast at Week 4.~      The secondary objectives are to assess the effects of lixisenatide on the maximum PPG~     excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma~     concentrations following a standardized breakfast, 24-hour profile of plasma glucose,~     glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and~     oxyntomodulin); and to assess the clinical and laboratory safety profile.~   "
143567|NCT01175460|"~     Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over~     30 fractions,and concurrent with s-1 and nedaplatin.~   "
143568|NCT01175447|"~     Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30~     fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70,~     and 80 mg/m(2)/day.~   "
143569|NCT01175434|"~     The goal of this new translational project is to test the feasibility and effectiveness of~     implementing school-based directly observed therapy of preventive asthma medications in a~     real-world setting, using state-of-the-art web-based technology for systematic screening,~     electronic report generation, and communication between nurses, caregivers, and primary care~     providers. With the use of a novel method to improve adherence and subsequently reduce~     morbidity, the investigators hypothesize that this novel adaptation of school-based asthma~     care will; 1) be feasible and acceptable among this population and among school and~     community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days,~     absenteeism, and emergency room / urgent care use for asthma care). The investigators~     anticipate that enhancing preventive healthcare for young urban children with asthma through~     partnerships with the schools using a novel technology will yield improved health,~     prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.~   "
143570|NCT01175421|"~     Purpose:~      In a retrospective cohort the investigators will validate, the goodness of a~     multidimensional index to classified the severity of patients with sleep disordered~     breathing that has been previously developed in a prospective longitudinal cohort.~   "
143571|NCT01175408|"~     Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In~     order to prevent complications, patients need to monitor and control their blood sugar~     levels. In addition, they may need to have an ongoing communication with their doctor in~     order to modify treatment. In this study the investigators wish to compare the benefits of~     continuous glucose monitoring system (CGMS) to an internet-based glucose monitoring system~     (IBGMS). The investigators also want to determine whether the frequency of blood glucose~     testing affects blood glucose control and to see whether the benefits of CGMS and IBGMS are~     independent of testing frequency.~   "
143572|NCT01175395|"~     The primary purpose of this study is to assess the safety & tolerability of an~     investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5~     mg in subjects with sub-foveal neovascular AMD.~   "
143606|NCT01174953|"~     The purpose of this study is to study the molecular effects of the chemopreventative agent,~     finasteride, in combination with dietary soy supplementation in patients at high risk for~     the development of prostate cancer. Also, the investigators intend to create a large~     database with health information from men who are at high risk of developing prostate~     cancer, along with serum and tissue samples from those patients who are willing to provide~     tissue and serum samples.~   "
143573|NCT01175382|"~     The primary aim of this project is to evaluate the effectiveness of combined behavioral +~     drug therapy compared to behavioral treatment alone and drug therapy alone as a way to~     improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined~     therapy will result in better outcomes than either behavioral or drug therapy alone. The~     second aim is to compare two methods of implementing combined therapy: simultaneously as~     initial therapy vs. stepped therapy, in which therapies are combined following initial~     behavioral or drug therapy alone. The third aim is to examine the costs and~     cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug~     therapy alone.~   "
143574|NCT01175369|"~     Asthma is the most common chronic illness of childhood, and hospitalization rates are~     increasing. In the US, impoverished children and children from minority ethnic and racial~     backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood~     Institute (NHLBI) guidelines recommend daily preventive medications for all children with~     mild persistent to severe persistent asthma, studies indicate that many children in the US~     who should receive preventive medications are not receiving them. The overall goal of this~     project is to target an ethnically diverse population of inner-city schoolchildren with~     asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that~     children receiving a comprehensive school-based intervention will experience less~     asthma-related morbidity compared to children receiving usual care. Our comprehensive~     school-based intervention consists of both administration of recommended preventive asthma~     medications in school (with dose adjustments according to NHLBI guidelines) and an~     environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children.~     Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who~     receive the school-based intervention with ETS reduction will experience less asthma~     morbidity than those who receive usual care.~   "
143575|NCT01175356|"~     This clinical trial is studying induction therapy followed by meta-iodobenzylguanidine~     (MIBG) labeled with iodine-131 and chemotherapy in treating patients with newly diagnosed~     high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance~     therapy with isotretinoin. Radioisotope therapy, such as MIBG labeled with iodine-131,~     releases radiation that kills tumor cells. Drugs used in chemotherapy, such as cisplatin,~     etoposide, busulfan, and melphalan, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell~     transplant can replace blood-forming cells that are damaged by MIBG labeled with iodine-131~     and chemotherapy.~   "
143576|NCT01175343|"~     This phase II trial is studying the side effects and how well RO4929097 works in treating~     patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer,~     or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
143577|NCT01175330|"~     The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the~     prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG~     surgery~   "
143578|NCT01175317|"~     58 patients undergoing surgery of the large bowel are divided into two groups. The control~     group will receive standard care. The intervention group will receive standard care plus~     optimization of the blood circulation based on in- or decrease of the output of the heart.~     Between group differences are measured primarily by markers of intestinal damage in plasma~     and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to~     the gut).~      The investigators hypothesize that the intervention group will have less intestinal damage,~     improved blood supply to the bowel and improved recovery of the operation compared to the~     control group.~   "
143579|NCT01175304|"~     The purpose of this study is the description of sleeping habits in a working population in~     the investigators health care environment, analyzing the prevalence of daytime sleepiness~     and symptoms compatible with the sleep apnea syndrome and finally to analyze predictors of~     daytime sleepiness.~   "
143580|NCT01175291|"~     The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic~     colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has~     not yet been approved by the U.S. Food and Drug Administration (FDA) for use in metastatic~     colorectal cancer or any other disease.~      This study will assess whether adding MK-0646 to an FDA-approved standard of care~     chemotherapy improves participants' duration of progression-free survival. MK-0646 is~     believed to inhibit the receptor of a protein called IGF-1 (Insulin-like Growth Factor)~     which is thought to contribute to cancer development and growth. However, there is no~     guarantee that MK-0646 will slow cancer development and growth.~      Other purposes of this study include:~        -  looking at the safety and tolerability of MK-0646~        -  comparing MK-0646 + standard of care chemotherapy with placebo + standard of care~          chemotherapy (placebo is a substance that looks like an active drug but has no active~          ingredient) The standard of care chemotherapy in this study is called FOLFOX 7. FOLFOX~          7 includes the drugs oxaliplatin with leucovorin, 5-Fluorouracil (5-FU), and~          bevacizumab.~   "
143581|NCT01175278|"~     The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the~     patient's fracture using balloons and bone cement) compares to non-surgical treatment in~     reducing vertebral compression fractures while providing pain relief and improved function~     and quality of life.~   "
143582|NCT01175265|"~     Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle~     strength, and health related quality of live but not pulmonary function in patients with~     chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in~     the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in~     this study is that pulmonary function, cardio-pulmonary exercise capacity, health related~     quality of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary~     rehabilitation plus breathing retraining will be better than that of patients undergoing a~     conventional pulmonary rehabilitation.~   "
143583|NCT01175252|"~     This study aims at collecting data to obtain baseline incidence and monitor trends over time~     in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age,~     before and after implementation of Rotarix™ universal mass vaccination in Brazil.~   "
143584|NCT01175239|"~     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in~     failure of development of the immune system in boys. This trial aims to treat SCID-X1~     patients using gene therapy to replace the defective gene.~   "
143586|NCT01175213|"~     The original purpose of the study was to assess the long-term safety, tolerability, and~     practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution~     (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with~     Primary Immunodeficiency Diseases (PID) who had completed Baxalta (formerly Baxter) Clinical~     Study Protocol No. 160603.~      Following a discussion with the FDA at the end of July 2012, all participants still active~     in the study stopped treatment with rHuPH20 to assure safety of the participants~     participating in the study and went into a safety follow-up.~      During this safety follow-up period, participants underwent either SC treatment with IGSC,~     10% or intravenous (IV) treatment with Immune Globulin Intravenous (Human) (IGIV), 10%. The~     IV or SC administration route was at the discretion of the participant and the investigator.~   "
143587|NCT01175200|"~     This study will establish the optimal therapeutic strategy for patients with a coronary~     artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring~     co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for~     treatment/prevention of GI ulceration.~   "
143588|NCT01175187|"~     Intrapartum fever associated with epidural anesthesia is caused by non infectious causes~     therefore without histological findings~   "
143589|NCT01175174|"~     Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute~     asthmatic attack presenting to the ED.~      Background:~      Children under the age of 5 years have the highest hospitalization rate of asthma. The most~     common causes of acute exacerbations of asthma requiring urgent medical care are viral~     respiratory infections. Most of these children < 6 y old are not atopic.~      The inflammatory response to these mostly viral-induced asthmatic attacks is not well~     characterized in the literature. Moreover it is not known whether different kind of~     inflammatory responses exist in this population and how this correlate to clinical outcomes~     and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic~     attack.~      Therefore, the purpose of the present study is to:~      Investigate the characterization of induced sputum cytology in preschool children with acute~     asthmatic attack and whether there is correlation between specific sputum cytology and~     response to therapy and to investigate airways hyper-responsiveness to adenosine~     5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3~     month following acute asthmatic exacerbation and look for correlation with response to~     treatment and sputum cytology. Clinical phenotypes of this patient population will also be~     investigated.~   "
143590|NCT01175161|"~     The purpose of this non-blinded randomized clinical trial is to pilot the design of a~     randomized clinical trial to be conducted in Malawi to investigate immediate postpartum~     insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to~     placement at the 6-week postpartum visit.~      The investigators hypothesize that it will be feasible to enroll 140 women into this study,~     and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.~   "
143591|NCT01175148|"~     Atorvastatin for prevention of acute GVHD~   "
143592|NCT01175135|"~     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of~     acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study~     will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for~     PF-02545920 compared to risperidone and placebo treatment.~   "
143593|NCT01175122|"~     In recent years, influenza viruses that have traditionally infected animals have infected~     humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United~     States in 2006, may pose a potential health concern to humans. This study will evaluate the~     safety of and immune response to a vaccine designed to protect people from the H2N3~     influenza virus.~   "
143594|NCT01175109|"~     This is a multi-center study to assess the safety and to determine the maximum tolerated~     dose of the combination of imatinib and LBH589 in patients with newly diagnosed and~     recurrent chordoma. For the recurrent population, those patients that do not require~     immediate surgical resection will be eligible. Patients will be treated with 4 cycles,~     followed by surgical resection if possible. If indicated, surgery may take place prior to~     the completion of 4 cycles.~   "
143595|NCT01175096|"~     RAD001 continues to be investigated as an anticancer agent on new indications such as~     neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and~     lymphoma based on its potential to act:~        -  directly on the tumor cells by inhibiting tumor cell growth and proliferation~        -  indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent~          inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced~          proliferation of endothelial cells)~      A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced~     carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and~     protein translation and the finding that somatostatin-induced growth arrest is mediated in~     part by inhibition of the PI3K pathway (Charland, et al. 2001).~      The present study is designed to collect safety/tolerability data and evidences for efficacy~     of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine~     tumor in Chinese patients.~   "
143596|NCT01175083|"~     The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK~     Biologicals' pneumococcal conjugate vaccine GSK1024850A.~      Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib~     and OPV vaccines.~   "
143607|NCT01174940|"~     To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative~     conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an~     allogeneic related or unrelated BMT or PBSC transplant, for treatment of hematologic or~     lymphoproliferative malignancies.~   "
143608|NCT01174927|"~     The aims of the study are to investigate the effects of diacetylmorphin (heroin) on brain~     using functional magnetic resonance imaging (fMRI), coupled with measurements of cortisol~     concentrations and neurophysiological stress parameters during the presentation of emotional~     and cognitive stimuli in patients with heroin dependence.~   "
143726|NCT01173380|"~     The investigators hope to learn about the effects of soy nuts on markers of health. When~     some people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small~     molecule made during metabolism). The investigators will be testing blood samples to~     determine if markers of health are different for people who make equol versus people who do~     not make equol.~   "
143597|NCT01175070|"~     Diabetic macular oedema (DME) is one of the leading causes of blindness in the United~     Kingdom's working population. It affects the macula, which lies at the centre of the retina,~     at the back of the eye. Damage to the macula can occur either because the blood supply is~     reduced (ischaemic DME), or because the blood vessels are leaking excessively (exudative~     DME).~      A chemical called vascular endothelial growth factor (VEGF) may underlie some of the~     abnormalities seen in DME. Studies have shown that VEGF encourages leakage of fluid from~     blood vessels and increases the stickiness of white blood cells. When white blood cells are~     sticky they can attach to blood vessel walls. This may cause small blood vessels to block,~     and lead to ischaemia.~      Laser treatment often helps to stabilise exudative DME, but there is currently no recognised~     treatment for ischaemic DME. Macugen (pegaptanib), a drug that inactivates VEGF, has been~     tried and found to be of benefit in treating exudative DME. Since VEGF promotes ischaemia,~     it is possible that Macugen will also prove to be beneficial for ischaemic DME. This has not~     been tested before.~      A healthy macula is essential for good vision. The innermost area of the macula, the foveal~     avascular zone (FAZ), is the most important part. The FAZ is enlarged when it is ischaemic.~     This is a pilot study to assess whether Macugen can reduce the size of the FAZ in ischaemic~     DME. The investigators will also assess whether it can reduce retinal thickness and improve~     vision in ischaemic DME. Thirty patients will be involved in the study for thirty weeks~     each. They will have their eyes examined and receive an injection of Macugen into the eye~     every 6 weeks. The study is taking place in the Oxford Eye Hospital and is being funded by~     Pfizer, the company that makes Macugen.~   "
143598|NCT01175057|"~     In this study feasibility of the MeDiNa concept is looked at, which means telemedical~     services for homely rehabilitation. With the help of microsystems technology, the relevant~     vital signs are measured at the patient`s home, then transmitted to the MeDiNa- Homebox-~     Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth-~     portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized~     network participants such as the family doctor or the patients themselves. In future, beyond~     cost advantages this will help to supervise risk patients or inspire patients to take more~     care of their health during homely rehab.~   "
143599|NCT01175044|"~     The purpose of this study is to examine the efficacy of a dilute betadine solution in~     reducing infectious complications in revision total knee arthroplasty. The investigators~     will enroll patients who are scheduled to undergo a revision total knee arthroplasty.~     Patients will be randomized into two groups. The treatment group will receive a dilute~     betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline~     irrigation and the control group will receive the 2000ml sterile saline lavage alone.~   "
143600|NCT01175031|"~     The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy~     of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended~     clinical polysomnography (PSG) in identifying breathing events in participants previously~     diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes~     respiration (CSR), or obstructive sleep apnea (OSA).~   "
143601|NCT01175018|"~     Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many~     patients die early during the course, and those who survive are at risk for dying late from~     adverse cardiac remodeling and heart failure.~      The initial ischemic damage to the myocardium initiates an intense inflammatory response in~     promoting further cardiac dysfunction and heart failure. The investigators propose that an~     antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory~     response and lead to a more favorable cardiac remodeling process.~   "
143602|NCT01175005|"~     Procalcitonin (PCT) is one of many inflammatory markers which rises in response to~     infection. Many studies have shown this marker to be more indicative of a patient's clinical~     course in comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate~     (ESR) and C reactive protein (CRP), when assessing a patient's risk for serious infection. A~     particular population with potential for serious infection is that of the patient with fever~     and a central line, most often secondary to an oncologic disease. These patients are often~     neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable~     to rapid declines in clinical status. By identifying a level of procalcitonin which is~     significant as a threshold for serious bacterial infection, the investigators can very early~     on identify the sickest patients and those who could potentially have a worse clinical~     course and/or outcome.~      The primary study goal is to identify whether a level of procalcitonin exists above which~     rates of bacteremia or serious bacterial infections in patients with fever and a central~     line exist. The investigators will try to determine if levels of PCT correlate with~     bacterial infection in line sepsis in the specific population of patients who most often~     have a central line secondary to an oncologic process. The investigators proposed this~     theory since peak values of PCT have been shown to be elevated in acute settings making it a~     useful tool in this particular population.~   "
143603|NCT01174992|"~     The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an~     adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight~     closure.~   "
143604|NCT01174979|"~     This trial is a randomized, double blind, placebo controlled study on patients suffering~     from inner ear diseases with tinnitus as a principal symptom.~      The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.~      Each patient will undergo treatment for 2 cycles of 48 hours each.~   "
143605|NCT01174966|"~     The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction~     of inspired oxygen (FiO2), called the oxygen challenge test (OCT), was associated with~     higher morbidity and mortality in human subjects. Patients had negative O2 challenge test~     results, indicating that flow-dependent O2 consumption might have been present. Recent~     reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure~     of carbon dioxide probes have observed a relationship between low oxygen challenge test~     values to mortality and organ failure. The OCT values provides an accessible noninvasive~     method of detecting early shock.~      To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to~     CI, DO2I、ScvO2.~      This study explored:~        1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to~          mortality;~        2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI,~          DO2, ScvO2.~   "
143609|NCT01174914|"~     In the vast majority of those infected with HIV virus who are untreated, there is~     deterioration in immune health over a period of months or years inevitably leading to~     full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if~     started before a certain degree of progression occurs and has saved millions of lives. The~     investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved~     medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably~     to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.~   "
143610|NCT01174901|"~     Headache is a common symptom, and patients often seek medical attention at emergency~     departments due to headaches.~      The aim of the CoHead Study is to find out if it is possible by measuring copeptin, a marker~     of stress in the blood, to find out which patients have simple headaches and which patients~     have dangerous headaches that are the symptom of an underlying disease and need further~     investigation and treatment.~      Copeptin is a marker for physical stress and has been tested in patients with stroke, heart~     attack and pneumonia. In all these illnesses, the patients with the most serious forms had~     the highest levels of copeptin, while the ones with only mild presentation or no affection~     at all had the lowest levels of copeptin.~      The investigators expect to show the same in patients with headaches.~   "
143611|NCT01174888|"~     RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone~     hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     bortezomib and midostaurin together with combination chemotherapy may kill more cancer~     cells.~      PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when~     given together with midostaurin with or without combination chemotherapy in treating~     patients with relapsed or refractory acute myeloid leukemia.~   "
143612|NCT01174875|"~     This study aims to test the following two hypotheses in women recruited in early pregnancy~     and whose children will be followed up till at least 9 years of age.~        -  Epigenetic changes in conceptual tissues obtained at birth reflect the environment that~          the fetus was exposed to during development.~        -  The pattern of epigenetic marks in gene promoters obtained from DNA in birth tissues,~          together with genotype, phenotype, and environmental exposures, can be utilized to~          assess how the perinatal environment affects subsequent metabolic, neurodevelopmental~          and other phenotypes.~   "
143613|NCT01174862|"~     In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly~     prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a~     significant number of grafts occluding in the postoperative period. This is partly~     attributed to reduced aspirin responsiveness, also called aspirin resistance. At the~     moment, no standardized definition or laboratory test is available to quantify aspirin~     resistance, and strong platelet reactivity in laboratory tests is not necessarily~     associated with increased thrombotic events. However, there is increasing evidence that~     reduced aspirin responsiveness in platelet function analyzers is associated with adverse~     long-term outcome and higher incidence of major adverse events in patients with stable~     coronary artery disease and in patients undergoing percutaneous coronary intervention. In~     patients undergoing coronary artery bypass graft surgery, the predictive value of a~     laboratory finding of reduced aspirin responsiveness remains unclear.~      Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or~     postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM~     platelet function analyzer is associated with higher incidences of adverse outcome after 30~     days and 12 months in patients undergoing CABG surgery.~   "
143614|NCT01174849|"~     The purpose of this study is to determine whether an early schedule of a combination of~     three doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or~     PHiD-CV.~   "
143615|NCT01174836|"~     Hypothesis: The majority of Emergency physicians and patients do not feel that specific~     informed consent should be obtained for ED CT scans.~      Secondary Hypothesis: Emergency attending physicians and residents will have similar~     attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT~     scans will change after an educational program about the associated risks.~   "
143616|NCT01174823|"~     The purpose of this study is to study the safety and efficacy of bepotastine besilate~     ophthalmic solution in allergic conjunctivitis patients.~   "
143617|NCT01174810|"~     Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus.~     Laboratory work has shown strong, reproducible evidence that this drug has beneficial~     disease modifying effects when given to animals with a range of experimental models of~     Parkinson's disease (PD). This project aims to make an initial evaluation of possible~     benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as~     a twice daily 10microgram injection under the skin in a similar way to one of the~     conventional symptomatic treatments for PD (Apomorphine).~      Forty patients with moderate symptoms of PD will be recruited and randomised to receive~     Exenatide injections twice daily, or to act as controls in this open label trial. Detailed~     assessments will be made of all patients at baseline and periodically for a total of 14~     months. The primary outcome measure will be the change between baseline and follow up, in~     the severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an~     overnight period free of conventional PD medication. Secondary measures will include adverse~     event reports, self completed questionnaires, and blood test results. Aside from these~     assessments, all patients will continue their regular PD medications throughout the trial~     with adjustments made only according to clinical need.~      In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be~     performed at both baseline and follow up to help understand possible mechanisms of action of~     Exenatide.~   "
143618|NCT01174797|"~     MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA)~     testing for the purpose of detecting active ischemia in patients with known or suspected~     coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion~     of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular~     tachyarrhythmias and sudden cardiac arrest (SCA).~   "
143619|NCT01174784|"~     This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a~     single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated~     during the index procedure through 30-day follow-up.~   "
143620|NCT01174771|"~     Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal~     1. Therefore, there is an urgent need to find alternative therapies to treat atypical~     parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive~     tool that modulates cortical excitability with minimal discomfort and holds therapeutic~     promise in treating neurological and psychiatric disorders.~      The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear~     Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and~     functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and~     hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and~     linked with non-motor symptoms such as depression and apathy. In this proposal, we~     characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose~     that high-frequency and low-frequency rTMS directed over separate motor and prefrontal~     cortical targets of each network may show specific and selective beneficial effects on motor~     vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome~     measures include timed finger tapping tasks. Quantitative cognitive outcome measures~     comprise a visual analogue scale (VAS).~      If successful, this pilot study will provide proof of principle data to suggest potential~     benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to~     support future PSP/CBGD studies that include the use of rTMS to investigate the~     pathophysiology of motor and non-motor features of PSP and CBGD patients.~   "
143621|NCT01174758|"~     Developing technology to increase efficiency and decrease cost of clinical trials. The~     longterm objective of this project is to use new technologies to sensitively measure,~     automatically analyze and efficiently manage clinical trial data for Parkinson's disease~     (PD) and other neurological disorders. This project will focus on developing objective~     measures of balance and gait because mobility disability and falls are so critical for~     quality of life in PD. Clinical movement disorders experts will team up with a local~     start-up business to develop, produce, and test a novel clinical balance and gait assessment~     tool, the instrumented Timed Up and Go Test (iTUG) for patients with Parkinson's disease.~     Balance and gait will be measured with wireless sensors worn on the wrists, ankles and trunk~     while patients stand up from a chair, walk, turn and return to sit on the chair.~     Accelerations and angular velocities from the sensors will be automatically transmitted,~     stored, analyzed, and displayed as Mobility Scores on a remote, centralized computer, along~     with other patient information important for clinical trials. Specifically, this proposal~     will 1) create a commercially-available, clinical trial system that includes completely~     wireless sensor technology, a custom-made, user-friendly, computer interface and efficient~     data management server; 2) develop a mobility score from many potential balance and gait~     measures and 3) compare the sensitivity of the iTUG compared to traditional clinical tests~     of balance to changes in PD due to antiparkinson medication. By providing a more sensitive,~     accurate, and comprehensive method to quickly test and analyze balance and gait, clinical~     trials to improve mobility in patients with Parkinson's disease and other neurological~     disorders will be significantly more effective and efficient. This will permit clinical~     trials in Parkinson's disease to be completed with fewer subjects, shorter duration, and~     less cost.The current project will accelerate the development of new therapies for~     Parkinson's disease.~   "
143622|NCT01174732|"~     This study is a randomized, active- and placebo-controlled, single-dose, seven-arm,~     crossover and dose-ranging design. This study aims to evaluate the efficacy and initial~     safety profiles, and to identify the optimum dose of A006, from a select dose-range for~     future clinical PK/PD and Phase III studies. This study is to be conducted in generally~     healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months~     prior to Screening.~   "
143623|NCT01174719|"~     The aim of the study is to compare three different regimens for volume replacement during~     cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).~      Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators~     hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even~     less expensive and as safe alternative has to be shown.~   "
143624|NCT01174706|"~     The main objectives of this research are:~        1. To identify factors that influence medication adherence rates in Emergency Department~          (ED) patients.~        2. To measure the effects of alternative information prescriptions on medication adherence~          rates of ED patients.~        3. To measure the effects of alternative information prescriptions (IRxs) on health and~          service utilization.~   "
143625|NCT01174693|"~     The purpose of this study is to compare the preventive effect of stroke between triflusal~     and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19)~     polymorphism.~   "
143626|NCT01174680|"~     The register study CGM@CAD will examine whether cardiogoniometry can provide additional~     information concerning the indication for a diagnostic coronary angiography and if so, which~     additional value it has. Therefore, an additional cardiogoniometry will be carried out in~     consecutive patients who have been diagnosed with myocardial ischemia by means of~     established methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or~     stress-MRT) and for whom an intracardiac catheter examination is regarded as indicated. The~     results of the different methods - particularly the results of the exercise ECG and the~     cardiogoniometry - will be checked against the results of the invasive examination as gold~     standard and the discharge diagnosis with regards to any correlation.~   "
143627|NCT01174667|"~     The aim of the study is to use diagnostic ultrasound to compare the thickness of soft~     tissues in the low back in a group of patients with chronic low back pain treated with~     massage to a control group of non-treated patients.~      It is hypothesized that on average, soft tissue thickness in the lumbar region will change~     in the group receiving massage compared to the control group.~   "
143628|NCT01174654|"~     Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk~     sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and~     some authorities have advocated methamphetamine treatment as an HIV prevention strategy.~     However, methamphetamine interventions have not been evaluated in controlled trials, nor~     have they been implemented and assessed outside of substance abuse treatment programs. This~     application proposes preliminary investigations to adapt a methamphetamine treatment~     intervention previously associated with decreased sexual-risk taking among MSM for use as an~     early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be~     enrolled in a randomized controlled trial of contingency management (CM) versus no~     intervention. CM participants will have their urine tested for methamphetamine 3 times~     weekly for 12 weeks, and will receive vouchers of escalating value when their urines test~     negative; vouchers will be withheld when participants' urines test positive for~     methamphetamine or participants miss urine testing visits. All participants will undergo~     urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior~     and substance use at baseline and at 6 week intervals for 6 months. Participants will be~     tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal~     gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM~     will initiate and complete the early intervention, and will longitudinally measure unsafe~     sexual behaviors among intervention and control participants. Study results will determine~     the feasibility of instituting and studying CM as an early intervention; define whether the~     intervention is sufficiently promising to justify a larger, definitive randomized controlled~     trial; and will provide estimates for defining the number of participants such a trial would~     require.~   "
143834|NCT01171950|"~     The purpose of the study is to evaluate the safety and effectiveness of the CentriMag~     ventricular assist system to help pediatric patients who have experienced heart failure~     during surgery and cannot be removed from cardiac bypass.~   "
143629|NCT01174641|"~     Problems in attention can affect around 40% of stroke survivors and are associated with poor~     recovery of function. This project will provide the largest scale and most detailed~     examination to date of whether problems in attention after stroke can be remediated through~     direct brain stimulation. In Part 1 of the project the investigators will use two forms of~     direct brain stimulation (neural inhibition) to try and balance activity across the two~     sides of the brain following a stroke to one side. The investigators will assess whether~     each form of stimulation leads to an improvement in attentional functions, as well as to~     wider improvements in other cognitive abilities and to activities of everyday living.~     Performance will be tested immediately post remediation and on longer-term follow-up, and~     performance of the two intervention groups will be assessed against data the investigators~     have collected from a large-scale screen of cognitive impairments and recovery of function~     under standard treatment conditions. In Part 2 of the project the investigators will take~     the most promising intervention from Part 1 and the investigators will use magnetic~     resonance imaging (MRI) to determine the brain changes that are linked to the recovery of~     attentional functions. The investigators will test whether recovery is linked to a change in~     the balance of activation within the two hemispheres of the brain, and whether there are~     associated structural changes in cortical tissue and fibre tracts. The project will evaluate~     whether neural inhibition can improve attentional functions in particular, and cognitive~     abilities and everyday activities more generally, in stroke survivors. It will also provide~     novel information on how recovery of function comes about within the brain.~   "
143630|NCT01174628|"~     The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on~     heart and lung function, quality of life, ability to work, symptoms of breathlessness and~     functional status of patients one year after their initial diagnosis and treatment for PE~   "
143631|NCT01174615|"~     The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell~     malignancies and associated conditions will serve as a convenient and comprehensive source~     of tissue to give us further information about the differences between normal blood cells~     and blood cells of affected individuals. This will be an invaluable asset for understanding~     the biology of blood disorders. The collected samples will be used by investigators for~     studies including immunology, molecular biology and genetics to name a few.~   "
143632|NCT01174602|"~     Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa~     improve their eating behavior.~   "
143633|NCT01174589|"~     The primary purpose of this study is to illustrate whether there is a difference in the 6~     minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of~     physical training after discharge from hospital.~   "
143634|NCT01174576|"~     The purpose of the study is to investigate whether caffeinated and decaffeinated coffee~     consumption has acute effects on subjective appetite feelings, energy intake and biochemical~     markers related to appetite, inflammation and glucose metabolism compared to water~     consumption.~   "
143635|NCT01174563|"~     This open-label, single arm study will assess the correlation between Tarceva~     (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced,~     recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for~     advanced disease. Patients will receive Tarceva at a dose of 150 mg daily orally, with dose~     adjustments according to protocol depending on toxicity. Anticipated time on study treatment~     is until disease progression occurs.~   "
143636|NCT01174550|"~     A prospective multicenter imaging study for evaluation of chest pain. Objective is to~     determine whether an initial non-invasive anatomic imaging strategy with coronary CT~     angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for~     coronary artery disease relative to an initial functional testing strategy (usual care).~     Study hypothesis: initial anatomic testing strategy will provide information that will~     result in superior long-term health outcomes as compared to an initial functional testing~     strategy.~   "
143637|NCT01174537|"~     Patients with specific metastatic cancers who failed prior therapeutic regimes will be~     treated with NDV for at least a year or until disease progression. The study will measure~     progression-free disease and posits that it will be extended.~   "
143638|NCT01174524|"~     The purpose of this study is to determine whether low-dose contraceptive pills are effective~     in the improvement of quality of life in patients in the different phases of menacme.~   "
143639|NCT01174511|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies~     and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the~     existence of at least two out of the four following criteria: itching, a chronic disease~     course with exacerbations and remission ,rash with characteristic distribution and shape ,~     atopia of the patient or family by history.~      Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and~     allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of~     Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients~     and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due~     to its following action mechanisms: sealing of the inflamed skin and retention of water,~     prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the~     herbal ingredients.~   "
143640|NCT01174498|"~     The increased incidence of pain syndromes requires the investigation of pathophysiological~     coherences as well as searching for new therapies. In the recent years neurostimulating~     techniques have been a promising approach regarding their analgesic effect. Combined with~     therapeutic standard procedures they can increase these effects and can have a positive~     impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient~     analgesic method in animal experiments and open clinical pilot studies amongst humans.~     Despite the lack of controlled approaches applying the method against defined pain~     syndromes, the stimulation of the vagus nerve has shown up as an effective method treating~     other psychiatric diseases like depression. The processing of stress, which is involved~     directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal~     stimulation. Compared with invasive methods the transcutaneous stimulation offers obvious~     advantages concerning appliance and occurrence of side effects. There are no studies so far~     dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of~     defined (chronic) pain related diseases using the t-VNS system. The study hypothesis implies~     a change of experiencing pain when applying the t-VNS in healthy subjects.~   "
143641|NCT01174485|"~     Liposuction is the most popular aesthetic surgery in Brasil and worldwide. Evidence showing~     that adipose tissue is a metabolically active tissue led to the suggestion that liposuction~     could be a viable method for the improvement of metabolic profile through the immediate loss~     of adipose tissue. Studies about the effects of liposuction on metabolic profile are~     conflicting. A few studies report the improvement of insulin sensitivity, inflammatory~     markers and lipid profile, others observe no changes and a few report the worsening of~     metabolic profile. In addition, animal studies show a compensatory growth of intact adipose~     tissue in response to lipectomy. Physical exercise improves insulin sensitivity, lipid~     profile, inflammatory balance, adipose tissue distribution and increases or preserves free~     fat mass. Therefore, liposuction and physical exercise seem to act on similar tissues of the~     body. To the investigators knowledge, there are no studies about the associated effects of~     liposuction and exercise in humans. However, one can suggest that exercise training~     associated with liposuction could: [1] attenuate or block the possible fat recovery or~     compensatory growth; [2] block or reverse the possible harmful effects of liposuction; or~     [3] exert an additive or synergistic effect to the possible beneficial effects induced by~     liposuction on metabolic and hormonal profile and inflammatory balance.~   "
143642|NCT01174472|"~     The aim of the study is to compare the feasibility and the effectiveness, by means of~     immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon~     angioplasty for the treatment of failing dialysis access.~   "
143643|NCT01174459|"~     The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol~     Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in~     routine medical practice.~   "
143644|NCT01174446|"~     The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK)~     parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in~     previously treated patients (PTPs) with severe and moderately severe hemophilia B.~   "
143645|NCT01174433|"~     To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent~     system for the treatment of single de novo bifurcation lesions in native coronary arteries.~   "
143646|NCT01174420|"~     The aim of this prospective randomized study is to investigate the efficacy and safety of~     trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in~     patients with medically uncontrolled open angle glaucoma.~   "
143647|NCT01174407|"~     The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in~     the pathogenesis of age-related macular degeneration. The aim is to asses a difference in~     expression rates of these factors on AMD-patients and a healthy control group.~   "
143648|NCT01174394|"~     This is a randomized, assessor-blind, placebo controlled study in post stroke depression~     patients. Subjects receiving antidepressant drug would be assigned to either active or~     placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention~     combined with antidepressants could produce greater therapeutic effects than antidepressants~     alone.~   "
143649|NCT01174381|"~     This study attempts to implement a lifestyle intervention programme aimed at changing the~     dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old~     adults in the MOH area, Ragama and measure the effectiveness of the programme.~   "
143650|NCT01174368|"~     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of~     subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel,~     cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or~     immunotherapy in the form of sipuleucel-T.~      The treatment is being evaluated for its effect on tumor growth. It consists of the~     placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA~     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or~     stop the growth of tumors in experimental animals and veterinary patients. It has been~     tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase~     II studies in patients with colorectal, pancreatic or prostate cancers are in progress.~   "
143651|NCT01174355|"~     A multicenter, open label, escalating dose study to assess the tolerability and the safety~     and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with~     attention deficit/hyperactivity disorder (ADHD).~   "
143652|NCT01174342|"~     The purpose of this study is to evaluate the effect of child delivery on the intraocular~     pressure in healthy women.~   "
143653|NCT01174329|"~     The objective of the study is to evaluate with clinical parameters the performance of~     Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary~     glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with~     symptoms of xerostomia.~   "
143654|NCT01174316|"~     The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive~     ventilation (NIV) versus standard NIV in patients admitted to hospital with acute~     exacerbation of chronic respiratory failure.~      The investigators hypothesise that autotitrating NIV will ventilate patients with acute~     exacerbations of chronic respiratory failure as effectively as standard NIV.~   "
143655|NCT01174303|"~     This trial is conducted in Europe. The aim of this trial is to investigate the exposure of~     NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1~     diabetes mellitus.~   "
143656|NCT01174290|"~     About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal~     delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium~     refers to a temporary change in the way a person thinks about things. Delirium occurs in~     patients admitted to the hospital particularly those patients that are very sick, who are~     given a number of medications, and who are not able to sleep normally. It affects their~     behavior, their understanding of the people and things around them, and their ability to~     make decisions. While ICU doctors do everything possible to eliminate the factors that may~     cause delirium, delirium may cause a person to become very agitated which if not controlled~     is dangerous to their safety as well as the safety of those around them. As well, if~     delirium develops in patients in the ICU, it may increase the risk for death, keep patients~     in both the ICU and hospital for longer and send patients to a long term care facility~     rather than home after they are discharged from the hospital. A recent medical report found~     that patients in the ICU who develop subsyndromal delirium have a mortality rate, a length~     of stay in both the ICU and the hospital, and a transfer rate to a long term care facility~     that is nearly as great as patients with delirium and greater than patients who develop~     neither subsyndromal delirium or delirium. Recent studies in non-ICU patients suggest that~     if a patient who is at high risk for developing delirium receives a medication called an~     antipsychotic (e.g. haloperidol) they may not be as likely to develop delirium or if they do~     develop delirium it will not last as long. No studies have evaluated the effect of~     administering an antipsychotic in patients in the ICU who have subsyndromal delirium.~     Another study completed in the ICUs at Tufts Medical Center found that there may be an~     association between the development of delirium in patients with subsyndromal delirium and~     the use of haloperidol. However, this small study had many limitations and thus it is not~     currently known whether using haloperidol in patients with subsyndromal delirium will~     actually cause fewer of these patients to develop delirium. Haloperidol makes a person~     sleepy and helps control behavior like agitation. Haloperidol is the drug that is used most~     often to help control delirium in the ICU. This prospective, double-blind, randomized~     controlled study will determine if haloperidol administered through the vein four times~     daily (1mg IV q6h) to patients who have subsyndromal delirium, and who are on a breathing~     machine and being cared for by the Medical ICU service at Tufts Medical Center, will help~     prevent patients from developing delirium. A total of 68 participants will be enrolled.~     Exclusion criteria are extensive and include conditions that could affect the ability to~     determine if delirium is present or increase the risk for side effects related to the~     administration of haloperidol. Patients older than 80 will be excluded from the study. Study~     medication (i.e. haloperidol) will be administered until one the following occurs: 1)~     delirium develops (that is confirmed by a staff psychiatrist or his designate, 2) the~     patient is discharged from the ICU at Tufts Medical Center, 3) the patient has received~     haloperidol or placebo for 10 days or 4) an adverse event potentially attributable to the~     study drug is experienced by a patient that is deemed, in the opinion of a pulmonologist~     member of the investigative team to warrant discontinuation of therapy. Haloperidol may~     cause unwanted side effects such as low blood pressure, twitching, and an unsafe abnormal~     heart rhythm. Patients with chronic confusion (e.g., a dementia such as Alzheimer's Disease)~     should not receive haloperidol and will not be included in this study. Patients will be~     carefully monitored for side effects that are potentially related to haloperidol. Patients~     who become confusion-free in the ICU before they leave the ICU (i.e., have no subsyndromal~     delirium) will be asked to provide consent for all research activities that occured in the~     ICU. If patients where cognition is regained (ie. no subsyndromal delirium or delirium) are~     not willing to provide consent then any study data collected from them while they were in~     the ICU will be destroyed and they will not be approached to participate in the post-ICU~     component of the study. This study also seeks to understand how the use of haloperidol in~     the ICU in patients with subsyndromal delirium may have affect memory, emotional status,~     happiness, ability to function, and quality of sleep in patients after they leave the ICU.~     Patients (that do not have delirium based on CAM screening at the time the 3-10 day and 6~     month assessments are attempted) will be approached to participate in this post-ICU~     component of the study.~   "
143657|NCT01174277|"~     By doing this study, researchers hope to understand the many changes that occur in the blood~     of people who have chronic GvHD. This may also help the researcher understand how ECP works~     and help guide therapy for patients who have chronic GvHD in the future.~   "
143658|NCT01174264|"~     This randomized clinical trial studies the effect of food on the pharmacokinetics of~     vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors~     prescribe correct doses and label the drug accurately.~   "
143681|NCT01173965|"~     Endometrial ablation in women with dysfunctional uterine bleeding using second generation~     ablation devices is a common widespread therapeutic approach. This study aims to prove that~     amenorrhoea rates using Novasure are higher than those observed in microwave endometrial~     ablation, one year following intervention.~   "
143682|NCT01173952|"~     This study is prospective evaluation of quality of life in men undergoing robotic assisted~     laparoscopic radical prostatectomy versus radical retropubic prostatectomy.~   "
143659|NCT01174251|"~     Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form~     of ventricular arrhythmia with a characteristic twist of the QRS complex around the~     isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden~     cardiac death. A predictor for the development of TdP is the length of the QT interval~     measured on an EKG recording. The QT interval is known to be prolonged by many medications~     used in a perioperative setting as well as by other conditions such as hypothermia and~     electrolyte imbalance. General anesthesia exposes most of the investigators patients to a~     combination of several of those medications and conditions and therefore might increase the~     risk for the development of QT prolongation. Moreover, patient related risk factors are well~     known and aggravate the individual risk for potential life threatening TdP events when~     exposed to QT prolonging medications perioperatively.~      Previous research suggests that more than 20% of the patients might develop QT prolongations~     perioperatively and are consequently on an increased risk for TdP; yet, no study has~     systematically investigated the magnitude of the problem and associated risk factors.~      The proposed pilot study is designed as a prospective observational cohort study to~     investigate the QT interval before, during and after general anesthesia. It aims to~     determine the incidence of perioperative QT prolongations. A customary long term EKG~     recording device will be connected to a random sample of patients undergoing general~     anesthesia. Using these continuous EKG tracings, the lengths of the QT interval will be~     analyzed during the perioperative period.~   "
143660|NCT01174238|"~     This is a two arm prospective Phase II pilot trial designed to determine the optimal~     duration of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma.~     In this study, 6 patients will be enrolled to Arm A, the FLT PET scan~     (3'deoxy-3'-18F-Fluorothymidine positron emission tomography scans)cohort. 30 patients will~     be enrolled to Arm B, the treatment-only cohort. 36 total patients will be enrolled. The~     treatment schedule will be the same in either cohort, with the exception of the FLT PET~     scans.~   "
143661|NCT01174225|"~     The goal of this study is to provide better information about contraception to women having~     an abortion so that they are less likely to have another unintended unwanted pregnancy.~      Participating subjects will receive their choice of contraception following their abortion~     and if this choice is an IUD they will be randomly assigned to one of two types of copper~     intrauterine devices.~      All participating women will fill out a survey about their contraceptive choices at the time~     of their abortion as well as at 3, 6, and 12 months afterwards. The investigators will also~     follow pregnancy rates at 1 through 5 years after the abortion to see which form of~     contraception was most effective.~      The investigators expect to find that IUDs are the most effective form of contraception but~     that the types of copper IUDs currently available in Canada are not known to be as effective~     as those available in other countries, for which high quality evidence is available. The~     investigators hope to use this data to determine the effectiveness of copper IUDs available~     in Canada.~   "
143662|NCT01174212|"~     Subjects will be consented and then determined randomly whether they will receive~     antibiotics prior to their surgery or during their surgery. Each patient will have cultures~     taken before and during their surgery from the infected hip or knee. Results will be~     compared after completion of the study.~   "
143663|NCT01174199|"~     RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill~     more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of~     temsirolimus and vorinostat in treating patients with metastatic prostate cancer.~   "
143664|NCT01174186|"~     Studies with intestinally asymptomatic patients with spondyloarthritis showed that~     approximately 1/3 had visible ulcers in the colon by scopic examinations and 2/3 had changes~     detectable by microscopy. Only those patients who improved in arthritis symptoms showed~     improvement in colonic changes. In these studies only colon and the terminal ileum was~     examined. Inflammation of the small intestine was not examined. Newer studies have shown an~     immunological link between Crohns disease and spondyloarthritis but not ulcerative colitis.~     The investigators wish to examine the small intestine in these patients before and after~     treatment, since they expect to find ulcers there linking spondyloarthritis to Crohns~     disease and healing after treatment.~   "
143665|NCT01174173|"~     The purpose of the study is to determine if the medication, ranolazine (study drug), can~     help improve blood flow to your heart, increase your exercise capacity and improve your~     quality of life (QOL). For this study, you will be asked to perform several tests in order~     to determine if your heart function, exercise capacity, chest pain and QOL have improved~     after 3 months of treatment with ranolazine. Ranolazine is approved by the U.S. Food and~     Drug Administration (FDA) for the treatment of angina.~   "
143666|NCT01174160|"~     This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in~     a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to~     sinus rhythm compared to placebo.~   "
143667|NCT01174147|"~     This study will evaluate the incidence rate of Candida blood stream infection (candidemia)~     among people hospitalized in participating medical centers in Brazil, and will assess the~     antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be~     tested in the study. Candida blood stream isolates collected from people hospitalized for~     any reason during the study period will be sent to a core mycology laboratory for antifungal~     drug susceptibility testing. All people who develop candidemia while hospitalized will be~     considered participants in the study.~   "
143668|NCT01174134|"~     The clinical trial will provide a milk-based drink with constant amounts of nutrients but~     differing amount of Docosahexaenoic Acid (DHA).~   "
143683|NCT01173939|"~     The study is being conducted to compare the effect of standard treatment (target LDL-C~     level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level:~     <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia~     patients with concomitant type 2 diabetes and hypertension.~   "
143684|NCT01173926|"~     This trial is conducted in Europe. The aim of this trial is to compare the blood~     glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250~     (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes~     mellitus.~   "
143845|NCT01171807|"~     The purpose of this study is to investigate the efficacy and safety of erythrocyte-mediated~     delivery of dexamethasone in steroid-dependent ulcerative colitis patients~   "
143669|NCT01174121|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy that involves taking white~     blood cells from patients' tumors, growing them in the laboratory in large numbers, and then~     giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes,~     or TIL and we have given this type of treatment to over 200 patients with melanoma.~     Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial,~     breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of~     white blood cells from the tumor that we think are the most effective in fighting tumors and~     will use only these cells in making the tumor fighting cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to~     see if this treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic digestive tract, urothelial, breast, or~     ovarian/endometrial cancer who have a tumor that can be safely removed.~      Design:~      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo~     a history and physical examination, scans, x-rays, lab tests, and other tests as needed.~      Surgery: If the patients meet all of the requirements for the study they will undergo~     surgery to remove a tumor that can be used to grow the TIL product.~      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      Treatment: Once their cells have grown, the patients will be admitted to the hospital for~     the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital~     for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.~   "
143670|NCT01174108|"~     Background:~        -  Stem cell transplants from related donors (allogenic stem cell transplants) can be used~          to treat individuals with certain kinds of severe blood diseases or cancers, such as~          severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow~          to replace that of the recipient. Because stem cell transplants can have serious~          complications, researchers are interested in developing new approaches to stem cell~          transplants that will reduce the likelihood of these complications.~        -  By reducing the number of white blood cells included in the blood taken during the stem~          cell collection process, and replacing them with a smaller amount of white blood cells~          collected prior to stem cell donation, the stem cell transplant may be less likely to~          cause severe complications for the recipient. Researchers are investigating whether~          altering the stem cell transplant donation procedure in this manner will improve the~          likelihood of a successful stem cell transplant with fewer complications.~      Objectives:~      - To evaluate a new method of stem cell transplantation that may reduce the possibly of~     severe side effects or transplant rejection in the recipient.~      Eligibility:~        -  Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a~          blood disease that can be treated with allogenic stem cell transplants, and who have a~          related donor to provide the stem cells.~        -  Donor: Individuals between 4 and 80 years of age who are related to the recipient and~          are eligible to donate blood.~      Design:~        -  All participants will be screened with a physical examination and medical history.~        -  DONORS:~        -  Donors will undergo an initial apheresis procedure to donate white blood cells.~        -  After the initial donation, donors will receive injections of filgrastim to release~          bone marrow cells into the blood.~        -  After 5 days of filgrastim injections, donors will have apheresis again to donate stem~          cells that are present in the blood.~        -  RECIPIENTS:~        -  Recipients will provide an initial donation of white blood cells to be used for~          research purposes only.~        -  From 7 days before the stem cell transplant, participants will be admitted to the~          inpatient unit of the National Institutes of Health Clinical Center and will receive~          regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress~          their immune system and prepare for the transplant.~        -  After the initial chemotherapy, participants will receive the donated white blood cells~          and stem cells as a single infusion.~        -  After the stem cell and white blood cell transplant, participants will have regular~          doses of cyclosporine and methotrexate to prevent rejection of the donor cells.~          Participants will have three doses of methotrexate within the week after the~          transplant, but will continue to take cyclosporine for up to 4 months after the~          transplant.~        -  Participants will remain in inpatient care for up to 1 month after the transplant, and~          will be followed with regular visits for up to 3 years with periodic visits thereafter~          to evaluate the success of the transplant and any side effects.~   "
143671|NCT01174095|"~     The primary aim of the study is to assess and follow-up subjects that received~     AdGVVEGF121cDNA in IRB protocol #0794-894 entitled Phase I Study of Direct Administration~     of a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to~     the Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease and IRB~     protocol #0297-693 entitled Phase I Study of Direct Administration of a Replication~     Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic~     Myocardium of Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive~     Surgery.~   "
143672|NCT01174082|"~     The goal of this clinical research study is to learn if vaccinating a donor with your~     purified myeloma protein and then injecting it back into you will help your immune system~     control the multiple myeloma.~   "
143673|NCT01174069|"~     Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be~     feasible and have comparable complication rates as standard lap cholecystectomy. Patient~     benefits will include less pain and scaring.~   "
143674|NCT01174056|"~     The purpose of this research study is to gain understanding of the basic responses of the~     lung to inflammation and specifically if a certain medication can reduce the inflammation~     alone or in combination with another. Inflammation is the way our bodies react to irritation~     or injury, and involves red, warm, and often painful swelling of the affected tissue. Acute~     lung injury involves inflammation that is not specific to one area of the lung and is~     caused by any one of several conditions: infection, trauma, breathing toxic substances, etc.~     When lung injury is severe, not enough oxygen can get into the body; this can lead to the~     need for mechanical support of breathing (mechanical ventilation), problems with brain,~     heart or other organ function, and in some cases, death.~   "
143675|NCT01174043|"~     This research study is looking for patients with newly diagnosed acute myeloid leukemia~     (AML), AML that has returned (relapsed), or it has not responded adequately to previous~     treatments. Treating certain patients with chemotherapy may not be to their benefit or may~     cause more harm than benefit. The purpose of this study is to find out what effects (good~     and bad) erlotinib has on patients and their AML.~   "
143676|NCT01174030|"~     The purpose of this vehicle controlled study is to evaluate the efficacy and safety of~     CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18%~     applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with~     moderate to severe facial erythema associated with rosacea.~   "
143677|NCT01174017|"~     This study compares the ability of a new design of brachytherapy seed for prostate seed~     implants for treatment of prostate cancer to maintain their intended position in the~     prostate after being deposited. Standard seeds, especially in apical locations, have a~     tendency to migrate distally in response to muscular forces. AnchorSeeds have a textured~     coating which is designed to prevent migration. 40 patients who are eligible and suitable~     for prostate brachytherapy will be randomly assigned to receive either standard seeds or~     AnchorSeeds.~   "
143678|NCT01174004|"~     The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin~     compared to placebo in patients with Parkinson's disease psychosis (PDP).~   "
143679|NCT01173991|"~     The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1~     diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may~     improve glycemic control, glycemic variability and quality of life.~   "
143680|NCT01173978|"~     The incretin effect in patients with type two diabetes is reduced. The investigators have~     previously shown that it is possible to induce a defect in the incretin effect in healthy~     individuals. The purpose of this study is to evaluate the insulinotropic affect of the~     incretin hormones in healthy individuals before and after a deterioration of the glucose~     homeostasis.~   "
143685|NCT01173913|"~     Oral administration has many advantages above intravenously administrated drugs for~     patients. Up to now, oral administration of docetaxel as single agent has not been feasible~     due to low and variable bioavailability. This low systematic exposure to docetaxel can~     effectively be increased after co-administration of ritonavir. The department of pharmacy of~     the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form~     for docetaxel, ModraDoc001 10 mg capsules.~      Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have~     been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic~     exposure after administration of those forms is now being investigated.~   "
143686|NCT01173900|"~     The aims of this study are:~        1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination~          programme in Tanzania.~        2. To measure the uptake and acceptability of two different vaccination strategies in~          rural and urban schools.~        3. To examine the characteristics of accepters/refusers of vaccination and to identify~          reasons for acceptance, refusal or non-completion.~        4. To measure the cost of implementing a school-based HPV vaccination programme in~          Tanzania.~   "
143687|NCT01173887|"~     This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 +~     KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated~     primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy~     to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall~     response assessment for antitumor effect. The secondary variables include response rate~     (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or~     response rates by lesion site in the best overall response assessment for antitumor effect,~     progression-free survival and overall survival. The safety and pharmacokinetic profiles of~     KW-0761 will be also determined.~   "
143688|NCT01173874|"~     The investigators hypothesize that cognitive remediation will be superior to the active~     control group on the change from baseline to study end point of cognitive remediation phase~     on both co-primary outcome measures (standardized composite MATRICS score and Cognitive~     Assessment Interview).~   "
143689|NCT01173861|"~     Purpose: Examine the effectiveness of cancer center-based physical activity counseling on~     physical activity rates and quality of life in breast cancer survivors.~      Hypothesis: Participants in the intervention group will indicate greater step counts and~     quality of life at the end of the intervention compared to the control group~   "
143690|NCT01173848|"~     The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in~     raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney~     disease who are not on dialysis.~   "
143691|NCT01173835|"~     The purpose of this study is to design an incentive-based intervention to motivate a~     tobacco-free lifestyle among high school students and to pilot the intervention in the first~     academic year in two schools (CT and NY) and examine feasibility and acceptability.~     Preliminary efficacy of the intervention will be assessed by implementing it in two new~     schools (CT and NY) in the second academic year and determine an effect size estimate for a~     larger trial.~      The study is intended to assess the number of students joining the program and pledging to~     be smoke-free and to examine changes in tobacco use rates and attitudes following~     intervention exposure. We hypothesize that the schools will have lower rates of tobacco use~     and improvement in attitudes, norms and behavioral control over tobacco use after~     participating in the program.~   "
143692|NCT01173822|"~     The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG)~     patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass~     circuit reduces transfusion and bleeding.~   "
143693|NCT01173809|"~     This prospective randomized study aims to investigate the effect of continuous versus~     interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP)~     atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).~   "
143694|NCT01173796|"~     This prospective, randomized study aims to compare the impact of ablation of perimitral~     flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of~     additional triggers, on procedure outcome.~   "
143695|NCT01173783|"~     It is the aim of this register to document the development of therapies by implantation of~     Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.~   "
143696|NCT01173770|"~     This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics~     and functional activity of ADC3680B after single and multiple doses in healthy male~     volunteers.~   "
143697|NCT01173757|"~     The purpose of this study is to evaluate the relationship between plasma drug levels and~     receptor binding in brain using PET; and to evaluate safety and tolerability after a single~     administration of PF-04995274 in healthy volunteers.~   "
143698|NCT01173744|"~     The objective of the study is to examine the treatment of unstable Intertrochanteric~     fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).~      This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will~     be randomized to be treated using either Gamma nail or DHS. The patients will be followed~     for 12 months. The primary endpoint is the clinical outcome as measured by the Merle~     d'Aubigne and Postelhip score.~   "
143699|NCT01173731|"~     The purpose of this study is to generate long-term safety, tolerability and efficacy data~     for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in~     PD-LID (Parkinson's disease, L-dopa induced dyskinesias).~   "
143700|NCT01173718|"~     This study is a prospective, non-randomized, multi-center evaluation of the performance of~     the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal~     Disease (ESRD), who are either currently receiving or expected to require hemodialysis~     through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6~     month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other~     arteriovenous grafts (AVGs).~      >~      >~      >~      >~      >~      > A total of 138 Subjects will be enrolled. Once the study procedure has been successfully~     completed, cannulation may occur at any time at the Investigator's discretion.~      >~      >~      >~      >~      >~      > Subjects will be selected from up to 20 Investigational Sites.~   "
143701|NCT01173705|"~     In this project, we propose to recruit lean and obese subjects with different ethnic~     background (African Americans and Caucasians) to study the alterations of lipid and~     carbohydrate metabolism and determine whether these disturbances are linked to genetic,~     inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation~     and insulin resistance are frequent features of obesity, we postulate that an unbalanced~     diet with high saturated- and low omega 3-fatty acids is linked to obesity-related~     inflammation and insulin resistance. We propose to investigate fatty acid metabolism and~     determine the links between fatty acid composition and oxidative stress in tissues of lean~     and obese subjects. We propose the following aims:~      Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard~     NHANES Food Questionnaire.~      Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue~     depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3~     content and inflammatory and oxidative stress markers.~      Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on~     inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes~     and monocyte culture.~   "
143702|NCT01173692|"~     The goal of this clinical research study is to learn if minocycline can reduce the symptoms~     reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer~     of head and neck, who receive treatment with radiation therapy.~   "
143703|NCT01173679|"~     Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are similar diseases~     of the white blood cells and are typically treated the same way. Recent research shows that~     a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN~     kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the~     death of CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should~     have some effect on CLL cells. The purpose of this study is to see of the study drug~     dasatinib, in combination with fludarabine and rituximab, is safe and effective to use for~     people with relapsed or refractory CLL/SLL.~   "
143704|NCT01173666|"~     The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a~     randomized controlled trial designed to evaluate the effect of renal artery stenting+medical~     therapy versus medical therapy alone on left ventricular mass progression and cardiovascular~     morbidity and mortality in patients affected by coronary artery disease and renal artery~     stenosis.~   "
143705|NCT01173653|"~     The emergency department (ED) serves a vital and growing role in the US health care system,~     responsible for both the delivery of emergent medical care and for safety-net care for~     populations without traditional access to health services. Uninsured populations rely~     significantly on the safety-net services of the ED. Between 2000-2005 the number of~     uninsured Americans increased from 39.6 million to 46.1 million, and this growth is expected~     to continue. Many health policy analysts consider the ED to be an effective place to provide~     preventative care. Prophylactic tetanus immunization, for example, has been a successful~     preventive health intervention that has become a standard of care in the ED setting. Brief~     smoking cessation interventions have been introduced in the ED but have not had great~     success based on lack of follow-up and continuity.~      Our study is novel in that it introduces a brief smoking intervention through use of an~     established, federally-funded and federally-sponsored cessation counseling resource, the~     National Smoking Cessation Quit Line, also available at smokefree.gov. This is a joint~     initiative between the Tobacco Control Research Branch of the National Cancer Institute and~     the Centers for Disease Control and Prevention. Since ED patients who smoke often lack the~     ability to use self-help cessation resources, we hypothesize that by introducing this~     population to the counselors on the National Smoking Cessation Quit Line (also called the~     1-800-QUIT-NOW line) during the ED visit via phone, that this new brief intervention would~     have a realizable and significant effect on smoking cessation among the this population.~   "
143706|NCT01173640|"~     Adverse events due to drug-drug and/or herb-drug interactions are of serious concern and a~     major cause of morbidity and mortality. Resveratrol is a polyphenol antioxidant that has~     been identified in over 70 species and is suggested to be the constituent in red wine~     responsible for cardioprotective effects. The potential health benefits of resveratrol~     supplements are highly extolled in the alternative medicine industry and daily doses are up~     to 5 grams are being studied. While there are potential health benefits of high doses of~     resveratrol, for patients taking other drugs metabolized by CYP3A4, such as transplant~     medications, chemotherapies and HMG-CoA reductase inhibitors, there may be a clinically~     significant herb-drug interaction.~      We, the investigators, have shown in vitro that resveratrol is a mechanism-based inhibitor~     of cytochrome P450 3A4 (CYP3A4). Based on our in vitro evidence and literature reports of~     the pharmacokinetics of resveratrol, we hypothesize that resveratrol will be a potent in~     vivo mechanism-based inhibitor of intestinal CYP3A4 enzymes. To date, there are no clinical~     studies that address the potential for a resveratrol-drug interaction. We propose to test~     whether single and multiple doses of resveratrol alter the pharmacokinetics of midazolam, a~     prototypic CYP3A4 probe drug.~   "
143707|NCT01173627|"~     The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test~     fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.)~     under fasting conditions.~   "
143708|NCT01173614|"~     The purpose of this study is to determine the average values of human ocular biometry and to~     correlate these values with visual function.~   "
143709|NCT01173601|"~     The primary purpose of this study is to assess whether at least one dose of LY2216684 (12 mg~     or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of~     patients with major depressive disorder (MDD) who were identified as partial responders to~     an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during~     an 11-week, double-blind, acute adjunctive treatment phase.~   "
143710|NCT01173588|"~     The aim of this study was to evaluate the effect of the consumption of yogurt added with~     bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product~     as herein described is expected to improve gastrointestinal function and maintain the~     intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel~     functions.~   "
143727|NCT01173367|"~     The impact of fever and its management in different medical and surgical populations of~     critically ill patients has not been explained to date. The current study aims to assess the~     safety and efficacy of treatment of critically ill patients with a permissive versus~     aggressive fever treatment strategy.~   "
143711|NCT01173575|"~     This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in~     patients with bacterial infection.~      Primary objective:~      • To assess clinical and microbiological efficacy of FOM in patients with bacterial~     infection.~      Secondary objectives:~        -  To determine the rate and severity of unexpected adverse events.~        -  To determine the mean duration of therapy with FOM in patients with bacterial~          infection.~      Study design:~      Multi-center, non-interventional study~   "
143712|NCT01173562|"~     The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg~     chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the~     treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such~     as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.~   "
143713|NCT01173549|"~     The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal~     glucose absorption in healthy volunteers.~   "
143714|NCT01173536|"~     This is a Phase I, single-center, three-arm, randomized, double-blind, active- and~     placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in~     healthy female subjects of non-childbearing potential.~   "
143715|NCT01173523|"~     STA-9090 blocks Heat Shock Protein-09 (Hsp90), which is thought to be involved in regulating~     apoptosis or cell death in small cell lung cancer.~      In this research study, the investigators will look to see if STA-9090 has a therapeutic~     effect on small cell lung cancer. The investigators will also study the safety of STA-9090~     and whether measuring circulating tumor cells may help in assessing response to treatment.~   "
143716|NCT01173510|"~     Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a~     deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to~     complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV~     infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to~     eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the~     integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved~     antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing~     integration of Human Immunodeficiency Virus (HIV). For participants with Human~     Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research~     study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human~     Immunodeficiency Virus (HIV)from key immune system cells.~   "
143717|NCT01173497|"~     The purpose of the study is to investigate the response rate for triple negative breast~     cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.~      Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess~     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been~     fully elucidated, however based on experiments on tumor cells performed in the laboratory,~     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of~     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell~     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell~     lines. Investigations into potential targets of iniparib and its metabolites are ongoing.~   "
143718|NCT01173484|"~     The diagnosis of gastroparesis suggests that delayed gastric emptying is the underlying~     cause of symptoms, but this description fails to explain the variable presentation. There~     are fundamental differences in causes, symptoms, and prognosis among patients with~     idiopathic gastroparesis. Understanding these differences is necessary in order to provide~     effective treatment in these patients. We believe our classification for gastroparesis is a~     useful tool in the management of patients with idiopathic gastroparesis to predict clinical~     severity, treatment response, and future prognosis.~   "
143719|NCT01173471|"~     The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,~     compared with placebo, over a 28-day period in patients with raised intra-ocular pressure~     (IOP).~   "
143720|NCT01173458|"~     The purpose of this study is to determine whether or not CTCs can be detected in blood~     samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare~     CTC analysis to tumor samples to look for differences.~   "
143721|NCT01173445|"~     The purpose of this study is to see if researchers can detect circulating tumor cells (CTC)~     and circulating endothelial cells (CEC) in the blood.~   "
143722|NCT01173432|"~     Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is~     abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose~     metabolism have been described, and it is suggested to play an important role in the~     pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may~     upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our~     group has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is~     present in the blood stream .The levels of A-FABP correlated with various metabolic variates~     in the metabolic syndrome. Furthermore, we have obtained novel data in men with a range of~     sleep disordered breathing showed that the duration of oxygen desaturation correlated with~     circulating levels of A-FABP, independent of age and waist/body mass index. The current~     proposal aims to pursue this finding and further explore the role of A-FABP in the~     association of OSA and metabolic dysfunction.~   "
143723|NCT01173419|"~     This is a multi center, randomized, comparison study using two already cleared methods of~     treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of~     the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for~     treatment of the GSV. Evaluation of post operative pain and bruising, quality of life~     assessments, adverse event assessments, confirmation of long term GSV closure, use of~     medications are criteria that will be evaluated during the course of this study.~   "
143724|NCT01173406|"~     The purpose of this study is to examine whether an education programme would enhance~     continuous positive airway pressure (CPAP) adherence.~   "
143725|NCT01173393|"~     That paramedic core cooling during CPR using a rapid infusion of ice-cold (4 degrees C)~     large-volume (30mL/kg) normal saline improves outcome at hospital discharge compared with~     standard care in patients with out-of-hospital cardiac arrest.~   "
143772|NCT01172769|"~     The purpose of this study is to determine whether temsirolimus is effective in the treatment~     of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)~   "
143728|NCT01173354|"~     Weight loss commonly occurs in patients with chronic obstructive pulmonary disease (COPD),~     negatively influencing their quality of life, treatment response and survival. Loss of~     muscle protein is generally a central component of weight loss in COPD patients. Attempts to~     reverse muscle loss in COPD by supplying large amounts of protein or calories to these~     patients have been unsuccessful. Gains in muscle mass are difficult to achieve in COPD~     unless specific metabolic abnormalities are targeted. The investigators recently observed~     that alterations in protein metabolism are present in normal weight COPD patients. Elevated~     levels of protein synthesis and breakdown rates were found in this COPD group indicating~     that alterations are already present before muscle wasting occurs. Furthermore, reduced~     plasma essential amino acid (EAA) levels were observed in COPD patients. These reduced EAA~     plasma levels were significantly related with the presence of muscle wasting in COPD. Until~     now, limited research has been done examining protein metabolism and the response to feeding~     in patients with COPD. Previous studies support the concept of essential amino acids (EAA)~     as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet~     no information is present on the anabolic effects of EAA in elderly COPD patients.~      It is therefore our hypothesis that a high-leucine essential amino acids mixture~     specifically designed to stimulate protein anabolism will target the metabolic alterations~     of COPD patients. In the present study, the acute effects of an EAA nutritional supplement~     on whole body, muscle and liver protein metabolism will be examined in COPD patients and~     compared to a supplement consisting of a balanced mixture of total amino acids. The~     principal endpoints will be the extent of stimulation of whole body protein synthesis as~     this is the principal mechanism by which either amino acid or protein intake causes muscle~     anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be~     assessed by isotope methodology which is thought to be the reference method.~   "
143729|NCT01173341|"~     The objective of this study is to define the clinical significance of the Neuregulin/ErbB~     signaling pathway and novel echocardiographic measures of cardiac function in predicting~     incident risk of chemotherapy cardiotoxicity.~   "
143730|NCT01173328|"~     Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen~     saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although~     PLB is a strategy that potentially reduces expiratory flow limitation, there are only few~     studies addressing its effects on exercise.~      This study aimed to assess the ability of PLB to change the breathing pattern, degree of~     dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise.~     Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated~     by forced oscillation technique.~   "
143731|NCT01173315|"~     The combination of vitamin and mineral supplementation may improve:~        -  glycemic control~        -  lipid profile~        -  oxidative stress~        -  blood pressure~        -  nephropathy indices~        -  neuropathy indices~   "
143732|NCT01173302|"~     This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5~     years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody~     response to a single booster dose. A total of 160 subjects would be enrolled. These subjects~     were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent~     is obtained, these subjects would be tested for their antirabies antibody titer and given a~     single booster dose. Seven and 14 days later, the investigators would re-evaluate the~     antibody titer.~   "
143733|NCT01173289|"~     The primary objective of this study is to estimate the 5 year locoregional control rate~     after External Beam Radiotherapy (EBRT) in the patient with locally advanced differentiated~     thyroid cancer. In a prior retrospective trial for this same group of patients, the 5 year~     locoregional control rate was 85% in EBRT group and 70% in no EBRT group. For the total~     number of patients to detect a minimum of 20% improvement in 5 year locoregional control~     rate with 80% of statistical power and the 5% significance level, the table for sample size~     planning given by Makuch and Simon was chosen. Forty-three patients are required for this~     regimen to regard as worthy of further investigation. Considering 15% follow up loss, 50~     eligible patients will be enrolled.~   "
143734|NCT01173276|"~     This study aims to assess the feasibility of a novel standard of care technique for~     intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study~     will involve couples in which the male partner is HIV positive, but the female partner is~     negative. The investigators will institute a protocol similar to those used presently~     throughout Europe with good success. To date, no HIV seroconversions have occurred in over~     4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on~     stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples~     will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female~     subjects will be followed post-insemination for seroconversion and pregnancy. Infants will~     be followed for seroconversion at birth through 4 months of age.~   "
143735|NCT01173263|"~     Eligible patients will be allocated to receive propofol sedation titrated to 3 different~     Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol~     sedation — as determined by BIS — lowers esophageal pressure in critical care patients.~   "
143736|NCT01173250|"~     Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical~     operation for management of ulcerative colitis and familial adenomatous polyposis. The~     addition of diverting ileostomy may reduce septic complications. In this randomized study~     the investigators compare two groups of patients with stapled ileoanal pouch one of them had~     diverting ileostomy and in the other this step is omitted.~   "
143737|NCT01173237|"~     With the development of the Intubation Surfactant Extubation technic, in which surfactant is~     administered during a brief intubation followed by immediate extubation, surfactant therapy~     can be given during nasal continuous positive airway pressure treatment further reducing~     need for mechanical ventilation. Preterm newborn babies until eight hours of life, with~     respiratory distress syndrome, will be randomized to standard delivery of surfactant via~     endotracheal tube airway inserted after premedication for pain with midazolam and~     remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent~     is to is to compare efficacy and safety of surfactant administration via two different~     airways and ventilatory approaches.~   "
143738|NCT01173224|"~     Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs~     are currently approved to treat influenza. This research will test the safety of an~     experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose~     of this study is to evaluate the safety of this new medication and how the body reacts to~     it. Any side effects will be measured by symptoms, physical examination or laboratory~     studies. About 27 healthy men and women age 18-45, who meet screening requirements, will~     participate. Three separate groups will be enrolled, with approximately 9 subjects in each~     group. Cohort 1:20 mg DAS181 or placebo for 1 day (total dose of 20 mg). Cohort 2: 20 mg~     DAS181 or placebo for 10 consecutive days (total dose of 200 mg). Cohort 3: 30 mg DAS 181 or~     placebo for 1 day (total dose of 30 mg.) Procedures include blood samples,~     electrocardiograms (measures heart activity) and breathing tests.~   "
143739|NCT01173211|"~     The purpose of this study is to see how much antibody (proteins produced by the immune~     system that help fight infections) the body makes after getting a flu vaccine. Researchers~     will also look at how the body reacts to the flu vaccine and how it affects the babies of~     pregnant women. The study will enroll approximately 240 women ages 18-39 years, including~     180 pregnant women in their second or third trimester of pregnancy (at least 14 weeks~     pregnant) and 60 non-pregnant women. Participants will be randomly (by chance) assigned to 1~     of 3 vaccine groups. Each participant will receive one shot of a 2010-2011 flu season~     licensed vaccine. The vaccine will be given as an intramuscular injection (shot in the~     muscle) in the upper arm. Study procedures include pregnancy testing, blood draws, and~     memory aids. Patient participation may be up to 8 months. The information from this study~     will help guide researchers in developing flu vaccines for pregnant women.~   "
143740|NCT01173198|"~     To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK~     (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK~     (Wavelight Allegretto 400 Hz platform).~   "
143741|NCT01173172|"~     This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and~     locally recurrent head and neck cancer. The primary end points are treatment toxicities and~     response rate. The secondary endpoints are time to tumor progression, progression-free~     survival, overall survival and change quality of life.~      Head and neck carcinomas that recur locally after conventional irradiation pose a~     therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture~     reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal~     energy to yield high energy alpha particles and recoiling lithium nuclei. The effect of~     alpha and 7Li is primarily limited to boron- containing cells. Preferential uptake of boron~     into cancerous tissue is achieved using boron carriers such as a derivative of~     phenylalanine, boronophenylalanine (BPA). After administration of BPA by an intra-arterial~     or intravenous infusion, the tumor site is irradiated with neutrons, the source of which is~     currently a nuclear reactor. A few uncontrolled clinical trials have evaluated BNCT in the~     treatment of glioblastoma after brain surgery. In these studies, the median survival times~     have been 13-15 months after BNCT. However, efficacy and tolerability of BNCT in the~     treatment of limited number of head and neck cancer patients showed promising results.~     Though many basic researches about BNCT has been done using Tsing Hua Open-pool Reactor~     (THOR) at National Tsing Hua University, no clinical trial utilizing BNCT is performed in~     our country. This study will be the first BNCT trial to treat head and neck cancer in~     Taiwan.~   "
143742|NCT01173159|"~     The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion~     containing fish oil) instead of the current lipid emulsion, which contains fat derived from~     soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated~     better. It may reduce the harmful effects to the liver, may stop any further liver damage~     and may reverse damage already done to the liver because of the prolonged use of nutrition~     through your child's IV.~   "
143743|NCT01173146|"~     Prostate Cancer is the most common cancer in men, affecting about as many men as women~     diagnosed with breast cancer, and killing about as many men per year as breast cancer kills~     women.~      The most common surgical treatment is prostatectomy, the removal of the prostate. During~     prostate surgery, tumor remains at the edge of the surgery, called residual tumor, in 30% of~     all prostatectomies. Such patients have a significantly higher risk of local recurrence of~     the cancer, and higher rates of death. In contrast, even patients with cancer outside of the~     prostate, but still nearby the prostate, do better when the margins are made clean of tumor~     during surgery.~      The investigators propose to reduce the number of patients with residual tumor after~     surgery. The investigators will test in patients a fluorescent molecule that allows cancer~     to be detected during surgery. If this trial works as designed, the investigators will~     reduce the number of patients who have to receive additional treatment, such as high doses~     of radiation to the lower abdomen, because the amount of residual tumor left behind has been~     minimized. This may also lead to higher rates of survival.~      This type of detection of cancer the investigators employ is called Molecular imaging. The~     investigators believe that molecular imaging will be the key to improved diagnosis,~     individualized treatment selection, and treatment monitoring.~      If successful, a large human trial will be conducted after this study with a corporate~     imaging partner.~   "
143744|NCT01173133|"~     The purpose of the study is to understand the relevance of tissue oximetry measures of~     tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable~     and early method of detecting compromised flaps.~   "
143745|NCT01173120|"~     The purpose of this study is to determine the safety and acceptability of a device used in~     place of traditional syringes for abatacept self-injection.~   "
143746|NCT01173107|"~     A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.~   "
143747|NCT01173094|"~     The purpose of this trial is to find out the appropriate way to treat DM patients with~     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of~     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.~   "
143748|NCT01173081|"~     This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive~     use of teriparatide for the healing of Jones fractures.~   "
143749|NCT01173068|"~     The aim of this study is to determine the outcomes when using ertapenem for complicated~     urinary tract infections in the OPAt setting.~      The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for~     complicated urinary tract infections in the OPAt setting.~   "
143750|NCT01173055|"~     Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.~     Researchers want to find out if a drug called milnacipran can help people with~     fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of~     fibromyalgia. In this study, milnacipran will be given to find out more about how it affects~     pain and thinking in people with fibromyalgia.~   "
143751|NCT01173042|"~     This pilot study will investigate the effects of acute peanut consumption on markers of~     inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will~     increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and~     that the addition of peanuts to the control meal will reduce the production of CRP, as well~     as triglycerides and glucose.~   "
143752|NCT01173029|"~     Renin-angiotensin-aldosterone system (RAAS) polymorphisms influence 24h arterial pressure~     fluctuation. Resistant systemic arterial hypertension (RSAH) has an increased risk of end~     organ damage and unfavourable prognosis, whereas pseudo-RSAH usually respond favourably to~     drug therapy.~      To prospectively investigate, in subjects with RSAH in a tropical South American city: 1)~     Adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial~     infarction (AMI); and 2) the association of RAAS polymorphisms and adverse cardiovascular~     events in this population.~      Study population: 212 hypertensives recruited from primary care assistance (time since first~     diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between~     2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year),~     57±10 years old, 66% females. Under drug treatment schedule: three or more drugs including a~     diuretic. Ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone~     system genetic profile determined. Genetic assessment was carried out using a polymerase~     chain reaction assay amplification technique. The following single nucleotide polymorphisms~     were analyzed: renin (G1051A), angiotensinogen (M235T), angiotensin converting enzyme-ACE~     (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and~     mineralocorticoid receptor (G3514C).~   "
143753|NCT01173016|"~     This is a single center pilot study in which Laronidase will be given weekly for two years~     in patients with Hurler syndrome, also known as mucopolysaccharide IH (MPS I, Hurler~     syndrome), that have previously been treated with an allogeneic transplant.~   "
143754|NCT01173003|"~     This open-label study is being conducted to determine whether national expansion of a 400~     mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following~     administration of mifepristone 200 mg is effective and acceptable to new abortion providers~     in 14 regions.~      The goal of this study is to provide answers to the following four questions:~        1. What is the effectiveness of this regimen of medical abortion with mifepristone~          followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual~          period (LMP)?~        2. Are the side effects with sublingual use tolerable for women?~        3. Is sublingual administration of misoprostol acceptable to women?~        4. Are women satisfied with counseling and services received in new centers offering~          medical abortion?~   "
143755|NCT01172990|"~     This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary~     Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/-~     stents will fare better that patients who are taken to the ward area and managed with drug~     therapy and stabilised for 24 hours before being taken to the catheter laboratory.~   "
143756|NCT01172977|"~     It is to be investigated if a correlation exist between the development of the HbA1c value~     and the complication rate is following a stroke.~   "
143757|NCT01172964|"~     RATIONALE: Genetically-modified neural stem cells (NSCs) that convert 5-fluorocytosine~     (5-FC) into the chemotherapy agent 5-FU (fluorouracil) at sites of tumor in the brain may be~     an effective treatment for glioma.~      PURPOSE: This clinical trial studies genetically-modified NSCs and 5-FC in patients~     undergoing surgery for recurrent high-grade gliomas.~   "
143758|NCT01172951|"~     The purpose of this study is to investigate the biological response to a metabolic stress,~     given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese~     individuals and to further explore these responses using novel metabolomic, proteomic,~     transcriptomic and genotyping techniques.~   "
143759|NCT01172938|"~     The purpose of this study is to determine whether apremilast is safe and effective in the~     treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms~     of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated~     patients.~   "
143760|NCT01172925|"~     The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for~     patients and upsetting for their family. Although drugs like morphine and oxygen can help~     some patients feel better, they don't help everybody, and they are not used in patients with~     early symptoms. More relief is needed for these patients. The investigators are studying a~     drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways~     to allow easier breathing. Every patient will get the drug but also a placebo, in a random~     (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they~     feel better with the drug.~   "
143761|NCT01172912|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. An autologous stem~     cell transplant may be able to replace blood-forming cells that were destroyed by~     chemotherapy.~      PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy~     together with stem cell transplant and to see how well it works in treating patients with~     metastatic germ cell tumors that have not responded to first-line therapy.~   "
143762|NCT01172899|"~     Rationale:~      In the Western world overweight and obesity is an increasing problem both in adults and in~     children. In youth, it is associated with early death and a number of co-morbidities~     including metabolic and endocrine changes, increased inflammatory status, cardiovascular~     abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.~      The standard treatment for morbid obesity in children is by combined life style~     interventions. However, the medium and long term effects of dietetic interventions,~     behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good~     results with up to 30% weight reduction in 3 years. The preliminary results in youth are~     similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in~     this age group is only allowed in clinical trials, until the benefits and risks have been~     established. (National Health Authorities)~      Objective:~      To determine if surgery gives a superior weight and body mass index (BMI) reduction than~     combined life style interventions in adolescents with morbid obesity and to assess its~     effect on obesity associated co-morbidity.~      Study design:~      Prospective randomised interventional study.~      Study population:~      Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI >40 kg/m2 or >35~     kg/m2 with co-morbidity.~      Intervention:~      Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style~     interventions~      Main study parameters/endpoints:~      Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary~     endpoints: Body composition, pubertal development, metabolic and endocrine changes,~     inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain~     development, quality of life, and behaviour changes. The potential complications of surgery~     are monitored.~   "
143773|NCT01172756|"~     The aim of this study is to assess whether single oral doses of Riociguat safely improve the~     cardiovascular function in patients with pulmonary hypertension associated with left~     ventricular diastolic dysfunction~   "
144140|NCT01167933|"~     The purpose of this study is to~        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg~          tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions~        -  monitor adverse events and to ensure the safety of subjects.~   "
143763|NCT01172886|"~     Healthy women and women with breast cancer have been enrolled in our nested case-control~     study between 2008 and 2009 in order to evaluate the association between metabolic syndrome~     and breast cancer, analyzing anthropometric parameters blood pressure, assessing serum~     HDL-C, triglyceride, fasting plasma glucose, insulin, testosterone and uric acid levels and~     administering a questionnaire about physical activity, food intake, tobacco use, alcohol~     abuse, personal and familial history of disease. Our data support the hypothesis that~     metabolic syndrome may be an indicator of breast cancer risk in postmenopausal women. The~     change of the hormonal arrangement in postmenopausal, along with an increase in visceral~     adiposity, probably favour the hormone dependent cell proliferation, which drives~     tumorigenesis. Adjustments in lifestyle with physical activity intensification and healthy~     diet may represent modifiable factors on which sporadic breast cancer primary prevention may~     work on.~   "
143764|NCT01172873|"~     This is a single site, open-label, feasibility study of cognitive behavioral therapy with~     exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS)~     for adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or~     non-responders to first line treatments of CBT or pharmacotherapy.~   "
143765|NCT01172860|"~     A new approach to treating solid tumours (both operable and inoperable) has been carried out~     by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland~     since 2002.~      The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour~     cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the~     tumour is aided through applying short electric pulses to the tumor mass (referred to as -~     Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug~     easier access into the cancer cells, whereas other tissues and organs in the body remain~     relatively poor at absorbing the drug, thereby reducing the potential side effects on~     healthy tissues. This approach to date has been limited to skin based tumours due to the~     requirement for the electrodes to be placed directly in contact with the tumour. Procedures~     with electrochemotherapy have been applied to human patients in other countries of the EU,~     the US and Japan.~      The drug concentration used is significantly reduced due to the more targeted absorption by~     the tumor and this significantly reduces side effects normally associated with chemotherapy.~      A large number of preclinical and clinical Phase I and I/II studies have demonstrated the~     efficiency and safety of ECT. These studies have included patients with melanoma, head and~     neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and~     adenocarcinoma nodules. Case reports concerning other primary tumours have also been~     reported.~      The investigators have developed an endoscopic approach (EndoVe system) for delivering the~     electric pulses to internal cancers and are currently seeking to evaluate its efficacy in~     the treatment of inoperable colorectal cancer. The treatment procedure is similar to~     standard endoscopic colorectal examination (colonoscopy) with the added element of an~     intravenous injection of bleomycin followed after eight minutes by the delivery of electric~     pulses (each one less than 1msec in duration). The pulses are endoscopically delivered~     directly to the tumour mass. The entire procedure is minimally invasive and does not require~     intensive care follow up or stitches. If the treatment is successful the tumour will shrink~     in size in the weeks following the procedure.~      The objective of this study is to investigate the efficacy and safety of this approach in~     reducing the size of the tumour.~   "
143766|NCT01172847|"~     This open label, randomized, three-period crossover study will evaluate the effect of~     co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of~     Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu,~     rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7~     days between treatments. Anticipated time on study is up to 11 weeks.~   "
143767|NCT01172834|"~     Strong evidence shows that physical activity (PA) has favorable psychological and health~     related outcomes. However, most employees do not perform enough PA to achieve health and~     well being benefits. Worksite interventions aimed at improving PA often yield modest effect~     sizes, and their theoretical ground is not profound. The Health Action Process Approach~     (HAPA), is a novel comprehensive theoretical model for health behavior change, that hasn't~     been studied as a whole in a worksite intervention study.~      The objectives of the proposed study are:~        1. To develop a coaching-based group intervention that will be both grounded in theory~          (HAPA) as well as applicable.~        2. To evaluate the feasibility of conducting this intervention among employed hospital~          nurses, using a randomized controlled design, interviews and other evaluation~          procedures.~      The proposed study will offer the most comprehensive empirical test to date of the full HAPA~     model.~   "
143768|NCT01172821|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium~     over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).~     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of~     maintenance treatment with inhaled corticosteroid controller medication in patients with~     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on~     lung function, effects on asthma exacerbations, effects on quality of life, effects on~     asthma control, effects on health care resource utilisation, and number of adverse events.~   "
143769|NCT01172808|"~     The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium~     over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).~     Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of~     maintenance treatment with inhaled corticosteroid controller medication in patients with~     moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on~     lung function, effects on asthma exacerbations, effects on quality of life, effects on~     asthma control, effects on health care resource utilisation, and number of adverse events.~   "
143770|NCT01172795|"~     Diffuse noxious inhibitory control In order to quantify central sensitization in chronic~     pain patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently.~     DNIC relies on painful conditioning stimulation of one part of the body to inhibit pain in~     another part, to remove the noise and to focus on relevant stimuli.~      Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients.~     However, the cause of this impairment is not yet elucidated, and further study is required~     to unravel the pathophysiology of DNIC in FM.~      Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal~     abnormalities could cause altered pain processing. Cortisol is released in answer to pain to~     suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal~     axis and the lower cortisol release in response to stressors in a proportion of FM patients~     and in chronic whiplash associated disorders (WAD) patients, the relation between pain and~     cortisol in these patients may be an interesting topic to consider.~      Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from~     severe concentration difficulties and decreased neurocognitive capabilities (reduced~     reaction time, short term memory deficits etc. The decreased neurocognitive performance is~     known to be related to pain severity in various chronic pain populations. It is hypothesized~     that malfunctioning of descending inhibitory pathways and subsequent chronic pain experience~     precludes optimal neurocognitive performance.~      Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC~     in chronic pain populations.~        1. Firstly, patients with FM, chronic WAD and healthy controls are compared regarding~          functioning of DNIC, cortisol levels and response and neurocognitive performance~          (case-control).~        2. Secondly, the possible interaction between the functioning of DNIC, cortisol and~          neurocognitive performance is studied in patients with FM, WAD and healthy control~          subjects (cross-sectional).~        3. Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and~          cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.~   "
143771|NCT01172782|"~     The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone~     injection for postoperative pain relief after knee arthroscopic surgery.~   "
143774|NCT01172743|"~     This protocol is designed to gather a small amount of blood for extraction of DNA for the~     study of the genetic basis of diabetes. The study population will include individuals with~     known diabetes, and controls without diabetes. Investigators aim to understand the genetics~     of diabetes, and will use the cells and serum from this blood to perform genotyping and gene~     expression studies of individuals with diabetes and relevant controls.~   "
143775|NCT01172730|"~     The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine~     to define the point of insertion and the depth of the epidural space compared to the blind~     technique.~      The study hypothesis is the use of Ultrasound will improve the success rate of epidural~     placement and may also decrease the rate of complications.~   "
143776|NCT01172717|"~     The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal~     growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people~     who fail or do not adequately respond to octreotide or other supportive therapies.~   "
143777|NCT01172704|"~     This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults~     (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and~     secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to~     Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and~     outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions +~     booster) was initially developed as the experimental condition in an R34 pilot project which~     demonstrated its feasibility and promise. For the proposed project, the investigators will~     recruit a larger sample which includes men and women with and without HIV, from various~     ethnic and racial groups, sexual orientations and housing arrangements, as well as a range~     of psychiatric disorders and functional capacities. In this way the investigators can more~     rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a~     sub-study after the 6 month follow-up to examine the impact at 12 months of an additional~     booster session for SB-MI participants. The investigators specific aims are:~        1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction~          strategy to CAU for people with serious mental illness. The desired outcomes include:~             -  Decreased frequency of risk behaviors (number of partners, number of encounters)~             -  Increased use of barrier precautions and IV needle cleaning~             -  Positive changes in information and motivation, as well as risk behaviors~             -  Increased HIV Counseling and Testing for those who do not know their HIV status~        2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½~          of participants randomized to SB-MI. The primary outcome will be:~             -  Decreased frequency of risk behaviors and increased use of barrier precautions at~               the 12 month follow-up~   "
143778|NCT01172691|"~     This study is being done to determine if patients receiving (iNO) will have increased liver~     function and less damage from IR than patients who do not receive (iNO).~   "
143779|NCT01172665|"~     The focus of this study is to create a database containing information about patients with~     celiac disease. This database will allow us to examine clinical and epidemiologic features~     of the University of Chicago Medical Center patient population. We have the largest~     population of patients with celiac disease in the mid-West and as such this study using~     information gathered from our database can greatly contribute to our current understanding~     of this disease.~   "
143780|NCT01172652|"~     The specific aim of this study is to evaluate the efficacy, tolerability, and safety of~     ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar~     disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current~     at least moderately severe anxiety.~   "
143781|NCT01172639|"~     The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the~     development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study~     introduced the principle of fast remission induction by means of a combination of standard~     Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose~     glucocorticoids in early Rheumatoid Arthritis.~      The purpose of the present study is to compare different combinations of traditional DMARDs~     and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid~     Arthritis.~      Besides the efficacy and effectiveness of these strategies, patient centered outcomes and~     potential implementation problems of such treatment strategies are evaluated.~   "
143782|NCT01172626|"~     The purpose of this study is to investigate the relationship between the side effects of~     valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms~     of drug metabolizing enzymes and pharmacokinetics of valproate sodium.~   "
143783|NCT01172613|"~     The purpose of this study is to determine the appropriate concentration of diagnostic~     reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai~     population with allergic rhinitis.~   "
143784|NCT01172600|"~     Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg~     of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl~     intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position~     of the needle, steroids and local anesthetic agents will be used according to the physician~     performing the block and will not be controlled by the study. Patients will be randomly~     assigned to receive either inhaled Entonox along with the interventional block they are~     scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those~     randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and~     also continue to receive it for a total of 4 hours in the recovery. Those randomized to the~     oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the~     procedure and recovery for 4 hours. Following completion of procedure the patient will be~     transferred to recovery and monitored for 3-5 hours then discharged home with instructions.~     Possible side effects will be monitored and recorded, pain score of patient will be recorded~     before discharge. All the patients will receive standard instructions regarding physical~     back exercises. This will be repeated for every procedure up to maximum of three blocks.~      The patients will be followed during each block and over a period of 1, 3, 6 and 12 months~     and on each follow-up visit will complete computerized set of questionnaires as they did~     before the procedure. The patients charts will be then reviewed for one year after the~     initial procedure to determine if further epidural steroid injections or surgery for the~     presenting problem were required. It is anticipated that the appropriate number of patients~     will be enrolled within six months of study initiation.~   "
143785|NCT01172587|"~     As they move from preadolescence to adolescence and adulthood, children need nurturing and~     supportive environments to realize their potential. Unfortunately, many children reside in~     destructive families that often result in negative short and long-term outcomes. As~     well-chronicled in the scientific and lay press, an all-too-common example involves parental~     substance abuse. Indeed, children living with a parent who abuses substances often have~     significant emotional, behavioral, and social problems. It has long been recognized that~     interventions are needed to address the clinical needs of these youth and to help prevent~     the development of problems that may emerge in early adulthood. To date, the majority of~     treatments have focused on either treating the children individually, or in the context of~     family therapy. Although directly involving these youth in treatment may be ideal, the~     majority of custodial parents who enter treatment for substance abuse are very reluctant to~     allow their children to engage in individual or family therapy. Thus, interventions for~     substance-abusing parents that do not directly involve children, but serve to improve the~     family environment as a whole, may have the greatest potential for reaching the most~     children and thereby positively influencing their overall adjustment and well-being.~      From this vantage, a promising approach is Behavioral Couples Therapy [BCT] for alcoholism~     and drug abuse, a comprehensive psychosocial intervention for substance abuse that focuses~     both on reducing addiction severity, improving couple adjustment, reducing interparental~     conflict and intimate partner violence (IPV), and improving the family environment and~     psychological functioning. In a series of preliminary studies, the PI found that children~     whose substance-abusing fathers and nonsubstance-abusing mothers participated in BCT~     displayed higher psychosocial adjustment at posttreatment and during an extended follow-up~     than youth whose substance-abusing fathers participated in individual-based treatment (IBT)~     or whose parents participated in a couples-based attention control treatment. These findings~     indicate that BCT may extend beyond the couple to their children and may provide an entry~     point into the family system from which to improve the adjustment of these youth.~      The present study is the next important step for this line of research. First, the present~     study is a far more developed examination of the potential effects of BCT on multiple~     dimensions of youth functioning, taken from multiple perspectives. Second, we do not know~     how BCT works. The positive effects of BCT on parents (reduced addition severity, improved~     dyadic adjustment, reduced partner violence, improved parenting, and improved parental~     psychological adjustment) may have positive trickle down effects on youth; however, we~     have not undertaken an empirical examination of these potential mechanisms of action. If we~     can understand how it works, we will be able to use that information to refine BCT to~     enhance the mechanisms that benefit youth. Thus, the present study will examine possible~     curative mechanisms. Third, we have a very limited understanding for whom it works. Thus,~     we will examine whether BCT may operate differently for children of different stages of~     development. If we can understand this moderating effect, we may be able to develop and~     refine BCT to meet the needs of families with children of different ages.~      To address these issues, the present study will examine how BCT is associated with changes~     in the emotional and behavioral adjustment, beliefs, and behaviors, including serious~     problem behaviors, of youth ages 5 to 18 (as rated by mothers, fathers, and the children~     themselves). We will also focus on potential mechanisms of action that are positively~     influenced by BCT.~   "
143786|NCT01172574|"~     The objective of this study was to explore the effectiveness of Motor Control Exercise on~     pain, postural alignment and spinal curvatures in women with osteoporotic vertebral~     fractures.~   "
143787|NCT01172561|"~     To increase early detection of cervical cancer by increasing the proportion of Appalachian~     women, age 18 and older, who receive Pap smears at appropriate intervals and return for~     follow-up care when necessary.~   "
143788|NCT01172548|"~     GISTs are the most common mesenchymal tumors of the gastrointestinal tract. Approximately~     95% of GISTs are positive for KIT (CD117)-the receptor for stem cell factor (SCF). GISTs are~     not responsive to conventional cytotoxic chemotherapy and disease often recurs even after~     complete resection with wide margins.~      Imatinib mesylate (trade names: Glivec® and Gleevec®, imatinib, formerly STI571) is a signal~     transduction inhibitor targeting several protein-tyrosine kinases that are believed to play~     a role in the proliferation of tumor cells. In the Phase II study of imatinib [CSTI571B~     2222] in 147 patients with recurrent or metastatic GIST, the partial response rates were 67%~     and 66% in patients treated at 400 mg/d and 600 mg/d, respectively. Skin rash and elevated~     transaminases were the most common reason for drug discontinuation. The most frequently~     reported AEs were mild nausea, vomiting, diarrhea, superficial edema (primarily periorbital~     or lower limb), myalgia and muscle cramps. Grade 3/4 events included fluid retention~     (pleural or pericardial effusions, ascites, and pulmonary edema), skin rash, liver toxicity~     and gastrointestinal (GI) hemorrhage. Myelosuppression (neutropenia and thrombocytopenia)~     was a consistent finding. Also, a tumor lysis-like syndrome occurred in some patients~     leading to gastrointestinal (GI) and/or intratumoral hemorrhage.~      In a Phase 3, American College of Surgeons Oncology Group trial (ACOSOG Z9001) of adjuvant~     imatinib, imatinib significantly improved 1-year recurrence-free survival (RFS) compared~     with placebo.~      In summary, clinical trials have shown that imatinib produces clinical benefit in most~     patients with unresectable or metastatic GIST and extends median survival from 19 to 57~     months. Imatinib is the standard of care for advanced GIST and has received regulatory~     approval for the treatment of unresectable or metastatic GIST. Studies suggest that adjuvant~     imatinib for 1 year prolongs RFS in patients at high risk of recurrent disease and~     metastases following complete surgical resection of the primary GIST.~      Imatinib is an appealing adjuvant therapy for resected GIST because:~        1. Patients with primary GIST have a high chance of tumor recurrence~        2. Conventional adjuvant treatment modalities are ineffective~        3. Imatinib specifically inhibits the Kit receptor which is constitutively activated in~          most GISTs~        4. Imatinib inhibits the growth of Kit positive cells in vitro~        5. Imatinib is highly effective in many patients with advanced GIST in a Phase II trial~        6. Imatinib has been associated with minimal toxicity in patients with advanced GIST and~          in patients with chronic myelogenous leukemia (CML)~        7. Imatinib may have its greatest impact on survival when there is minimal disease.~      Primary~        -  To assess Recurrence Free Survival Rate in patients with resected primary GIST who are~          treated with adjuvant imatinib for a duration of 2 years Secondary~        -  To compare Recurrence Free Survival, Overall Survival, and Time to Recurrence of~          patients with resected primary GIST who are treated with adjuvant imatinib for a~          duration of 2 years with historical data To assess the safety of imatinib given as~          adjuvant therapy for 2 years in patients with resected primary GIST~   "
143789|NCT01172535|"~     Treatment of children and infants with HIV requires modification of medication dosing~     according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line~     treatment option that is increasingly necessary due to infant drug resistance, this dosing~     is often complicated and impractical in busy clinical settings. To address this, the World~     Health Organization (WHO) has released a simplified dosing table based on infant weight~     bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants~     when dosed according to the new WHO guidelines.~   "
143790|NCT01172522|"~     This study examines topical treatment of under eye circles and swelling.~   "
143791|NCT01172509|"~     Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop~     measures of human synaptic plasticity and of brain excitatory:inhibitory ratio (E:I ratio),~     which we propose as novel biomarkers and outcome measures that will expedite clinical trials~     of treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent,~     R-baclofen will be investigated under this protocol.~      TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain.~     Presently, TMS is in extensive use as a means to measure regional brain excitability, which~     is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic~     strength as well as to acutely measure levels of cortical excitability and short and long~     interval inhibition. Since altered synaptic plasticity and an imbalanced~     inhibitory:excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize~     that both severity of ASD-related learning deficits and their improvement after therapy will~     correlate with TMS measures of synaptic plasticity and E:I ratio. We propose to embed TMS~     measures of synaptic plasticity and E:I ratio in a 'Proof of Principal' trial of R-baclofen~     and to examine:~      Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS~     measures of synaptic plasticity and E:I ratio as a function of plasma concentration in adult~     volunteers. We will test the following hypotheses:~        1. R-baclofen produces a significant change in TMS measures of LTD and E:I ratio; and~        2. R-baclofen plasma levels and TMS measures of LTD and E:I ratio show a predictable~          exposure-response relationship.~      Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B~     receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will~     test the following hypotheses:~        1. Presence of the BDNF val66met allele will be associated with decreased long-term~          depression (LTD) of cortical excitability~        2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of~          response to R-baclofen as measured by TMS~   "
143792|NCT01172496|"~     This single center, open label, randomized, two-period, two-sequence cross-over study is~     designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg~     tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four~     0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other~     secondary outcomes of interest include assessment of pharmacokinetic parameters of~     treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral~     solution administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and~     evaluation of the safety and tolerability of each treatment regimen.~   "
143793|NCT01172483|"~     Summary: (Objectives and methodology of the project) AIM: To evaluate the clinical~     effectiveness of Community physiotherapy intervention on chronic diseases (heart disease,~     chronic obstructive pulmonary disease, back pain, mechanical neck pain, fibromyalgia,~     osteoarthritis lower limbs, neurological and cancer survivors) and a group of healthy~     patients cardiovascular risk factors. DESIGN: Randomized, controlled, prospective study.~     SUBJECTS OF STUDY: Patients with chronic disease go to the Local Sports Torremolinos Center~     INTERVENTION: Establishment of a control group that give you some advice education care~     (brief advice) and a group common experimental multimodal program of 12 weeks therapeutic~     exercise with health education (brief advice). It will follow up complete with ratings pre~     and post intervention to both groups and follow up at 6 and 12 months for long-term effect~     through specific questionnaires for each subgroup chronic disease and pain score (visual~     scale analog), quality of life (EuroQol-5D) and state health general (Short-Form 12, SF-12)~     VARIABLES: The intervention physical therapy Community. Result: Specific questionnaires for~     each subgroup, pain (Visual analogue scale), quality of life (EuroQoL) and general health~     status (SF-12). DATA ANALYSIS: descriptive statistics, measuring central tendency and~     dispersion of the variables study. Inferential statistics will be made between intervention~     of key variables and outcome (Chi square, Student t, ANOVA, Mann-Whitney, Wilcoxon, by type~     and normal variables). Likewise, establish measures of effect size in main outcome~     variables, by reduction relative risk, absolute risk and odds ratio with their respective~     confidence intervals.~   "
143794|NCT01172470|"~     The purpose of this study is to determine 1-year survival of previously irradiated Head and~     Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction~     chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin~     and daily radiotherapy.~   "
143795|NCT01172457|"~     The aim of this study is to assess the efficacy and safety of ozone therapy (vs. placebo)~     applied into the epidural space through epiduroscopy in Patients with Failed Back Surgery~     Syndrome. It´s a Prospective, double blind, randomized study. The investigators will study~     30 patients of both sexes between 18 and 70 years with chronic back pain after lumbar spine~     surgery for more than six months. The patients will receive the ozone gas or placebo~     (oxygen) in the lumbar epidural space, using a spinal endoscope inserted through the sacral~     hiatus by local anesthesia or sedation. The patients will be evaluated before the procedure,~     with 30 days, with 3, 6 and 12 months after intervention. This will be run by a researcher~     who will have no knowledge of the gas (oxygen or ozone) to be injected into the lumbar~     epidural space with the aid of an epiduroscopic. Will be applied before and after the~     procedure, pain scales (VAS, McGill, Neuropathic Pain 4, Neuropathic Pain Symptom~     Inventory), quality of life scale (WHOQOL), functional scales of pain disability (Roland~     Morris and Oswestry Disabilities Scales). Only one researcher will keep the data~     confidential until the end of the study.~   "
143796|NCT01172444|"~     An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish~     Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal~     Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative~     Proctitis will be conducted in 533 patient with a estimated duration of 18months.~   "
143797|NCT01172431|"~     The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal~     function, endothelial function, blood pressure variability by comparison with~     hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and~     Hypertension.~   "
143798|NCT01172418|"~     The purpose of the present study is to determine which antibody induction regimen will~     result in a safer and more effective method to use with steroid avoidance in renal~     transplant recipients. Patients receiving either first cadaveric or non-HLA identical living~     donor kidney transplants will be preoperatively randomized into 2 groups.~   "
143799|NCT01172405|"~     Based on established therapeutic effect of ibuprofen in the treatment of headache attacks,~     and the action of caffeine in promoting better results when combined with treatments of~     first choice in the treatment of headache, this study is designed to:~        -  evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients~          compared to ibuprofen alone;~        -  evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen~          alone.~      The hypothesis is that the association is superior to treatment with ibuprofen alone in~     terms of efficacy, while maintaining good tolerability.~   "
143800|NCT01172392|"~     The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated~     interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)~   "
143805|NCT01172327|"~     The purpose of this study is to examine the effectiveness and safety of a self-directed~     physical activity program relative to a self-directed dietary program in adults with~     arthritis. A process evaluation will also be conducted to examine program reach,~     participation/dose, fidelity, and participant compatibility/satisfaction.~   "
143806|NCT01172314|"~     Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of~     life, treatment response and survival. Gains in lean body mass are difficult to achieve in~     cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a~     nutritional supplement containing a high amount of essential amino acids will target the~     metabolic alterations of cancer patients. Preliminary research performed in our laboratory~     in elderly supports this hypothesis. We hypothesize that intake of an essential amino acid~     nutritional supplement will positively influence protein synthesis rate in advanced~     non-small cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying~     mechanism of the higher anabolic response of the essential amino acid supplement will be~     examined. This information will potentially enable us to formulate a supplement that is more~     effective than normal food intake, and that will reduce the need for muscle protein~     breakdown.~   "
143807|NCT01172301|"~     Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis~     (CF), negatively influencing their quality of life and survival. At the time of a diagnosis~     of CF, severe protein deficits can already be present. It is important to get CF children~     fed adequately to prevent that their condition becomes worse or that recovery takes longer.~     Oral supplementation trials showed that gains in lean body mass are difficult to achieve in~     CF unless specific metabolic abnormalities are targeted. However, the specific needs for~     certain food components are not clear yet in children that are ill. Therefore, more~     information is necessary on the need for protein and certain amino acids in children with~     CF. Previous studies support the concept of essential amino acids (EAA) as an anabolic~     stimulus in the young and elderly and in insulin resistant states. Until yet no information~     is present on the anabolic effects of EAA in CF.~      It is therefore our hypothesis that a high-leucine essential amino acids mixture~     specifically designed to stimulate protein anabolism will target the metabolic alterations~     of pediatric subjects with CF. In the present proposal, the acute metabolic effects of this~     high leucine essential amino acids mixture will be examined in pediatric subjects with CF~     and compared to that of a regular balanced total mixture of essential and non-essential~     amino acids. The principal endpoints will be the extent of stimulation of whole body protein~     synthesis as this is the principal mechanism by which either amino acid or protein intake~     causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints~     will be assessed by isotope methodology which is thought to be the reference method.~   "
143808|NCT01172288|"~     Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple~     motor and vocal tics that last for at least a year in duration. Currently, there exist~     several effective pharmacological treatments for childhood tics including alpha-2 agonist~     medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These~     medications, however, have significant side-effects and are only partially efficacy in~     treating tics.~      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate~     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in~     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen~     with NAC is nausea and this side-effect is seldom seen in the doses used in this trial.~      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled~     trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to~     be closely related to tics because these conditions (1) have similar clinical~     characteristics -- both groups typically experience urges before engaging in pulling or~     tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal~     ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both~     conditions and (4) they tend to be inherited together in families. In other trials NAC has~     evidence of some efficacy in treating diverse psychiatric conditions such as bipolar~     depression, schizophrenia and cocaine dependence.~      The investigators are conducting this trial to determine if NAC is an effective treatment~     for tics.~   "
143809|NCT01172275|"~     Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators~     currently have effective first-line interventions for pediatric OCD such as Cognitive~     Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs).~     However, roughly half of children with OCD still have clinically significant OCD symptoms~     despite treatment with first-line pharmacological treatments and CBT interventions for OCD.~     Furthermore, all pharmacological treatments for OCD in children have an increased side~     effect burden when compared to adults. Novel treatments for children with OCD are needed.~      N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate~     modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in~     this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen~     with NAC is nausea and this side-effect is seldom seen in the doses used in this trial.~      NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled~     trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an~     obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In~     other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions~     such as bipolar depression, schizophrenia and cocaine dependence.~      The investigators are conducting this trial to determine if NAC is effective in treating~     OCD.~   "
143810|NCT01172262|"~     Tinnitus is a poorly understood symptom that is often described either as ringing, clicking,~     ocean sounds, or nature sounds. There is no cure for tinnitus. Approximately 50 million~     Americans are affected with a small minority being severely affected. This study targets~     patients with tinnitus who are severely bothered. Through MRI the investigators plan to~     evaluate the cortical networks of the brain in hopes to better understand this complex~     process.~   "
143861|NCT01171599|"~     The purpose of this National Cancer Institute (NCI) funded study is to develop and test the~     acceptability and usability of a web & text message based weight loss intervention for~     childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 -~     18 will provide feedback during focus groups on a web and text message based program that~     was developed.~   "
143811|NCT01172249|"~     This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority~     study in 250 individuals (125 individuals per group), with 204 evaluable patients with~     clinical and radiological diagnosis of osteoarthritis of the knee.~      Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate~     500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication~     (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).~      Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling,~     stiffness in the joint, consumption of paracetamol and quality of life.~      The safety assessment will be done by monitoring the incidence of adverse events and their~     relation to the treatment.~   "
143812|NCT01172236|"~     The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its~     ability to reduce free radicals related diseases in the newborn. This evaluation will be~     done through the assessment of neuro-developmental follow-up.~      The secondary objective is to identify a panel of markers for assessing oxidative stress and~     for a correlation with the lactoferrin antioxidant effect.~   "
143813|NCT01172223|"~     Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or~     amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with~        -  Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks),~        -  Paclitaxel (175 mg/m^2 i.v. day 1 q3 weeks), and~        -  Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive~          surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable~          toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor~          size <25% after 4 courses measured by ultrasound or MR-mammography), or if the patient~          requested to be released.~   "
143814|NCT01172210|"~     A substantial percentage of individuals with bulimia nervosa (BN) also meet criteria for a~     co-occurring substance use disorder, such as alcohol abuse or dependence; however, research~     examining this sub-group of patients with BN is limited. Understanding characteristics~     common to both eating and alcohol use disorders may enhance understanding of the mechanisms~     that could contribute to the co-occurrence and perpetuation of these disorders. Individuals~     with BN and alcohol use disorders appear to share some behavioral traits, and therefore, the~     primary aim of the current study is to compare patients with BN with and without an alcohol~     use disorder and normal controls on measures assessing an individual's mood and ability to~     perform certain tasks. Participants will be asked to complete computer-administered and~     paper-and-pencil assessments and two laboratory test meals on separate days. By probing the~     underpinnings of BN and alcohol use disorders, the investigators can determine whether these~     disorders have a shared diathesis, which will lay an essential foundation for future~     research to examine biological and genetic correlates of these disorders. Finally, as little~     is known about the treatment of patients with BN and a co-occurring alcohol use disorder, an~     exploratory aim of the current study is evaluate the suitability and efficacy of a~     20-session cognitive-behavioral treatment (CBT) addressing both bulimic symptoms and alcohol~     use.~   "
143815|NCT01172197|"~     The anaesthetic management of patients undergoing total knee replacement is still not~     standardised. Epidural analgesia is common, but is associated with bilateral lower limb~     motor block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides~     good pain relief, but only for 12 to 16 hours, and is often associated with nausea and~     vomiting. Combined single injection femoral / sciatic blocks give good pain relief, but for~     a variable length of time (between 12 and 24 hours).~      In contrast, continuous femoral perineural infusion of local anaesthetic provides very good~     pain relief for several days. Pain relief is maintained by a constant infusion of local~     anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a~     local anaesthetic regimen which offers complete pain relief for at least 48 hours, yet~     allows full mobilisation within 24 hours Given that ropivacaine may offer a more~     advantageous pharmacological profile (less lipid solubility) compared to levobupivacaine,~     the investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent~     pain relief after surgery. Thus, the investigators aim in this study is to compare the ED50~     of levobupivacaine with the ED50 of ropivacaine for preventive pain relief after total knee~     replacement. Further, calculation of the equipotent ED50's of each local anaesthetic allied~     to objective measurement of quadriceps motor block using an electromyogram (EMG) will allow~     us to determine the sensory - motor split of each local anaesthetic.~   "
143816|NCT01172184|"~     A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is~     associated with a poor outcome, regardless of systolic function. Thus, the LA volume~     provides a long-term view of whether the patient has diastolic dysfunction, regardless of~     the loading conditions present at the examination, such as hemoglobin A1c in diabetes~     mellitus. To date, the relation between the LA volume and left ventricular (LV) filling~     pressure has not been confirmed directly by simultaneous echocardiographic catheterization.~     The present study, therefore, assessed the correlation between the LA volume and LV filling~     pressure in patients with severe mitral regurgitation (MR). Because the LA pressure~     increases to maintain adequate LV diastolic filling, increased atrial wall tension tends to~     dilate the chamber and stretch the atrial myocardium. Therefore, the lower the ability of~     the left atrium to stretch, the greater the pressure in the left atrium. The study is~     designed to assess 1) the relationship between LV filling pressure and LA distensibility,~     and 2) the power of left atrial distensibility to predict the prognosis, including operation~     mortality, the rate of post-operation atrial fibrillation, and late heart failure event in~     patients with severe mitral regurgitation.~   "
143829|NCT01172015|"~     Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is~     estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease~     that represent 70% of adult cases are associated with impairment of quality of life related~     to treatments side effects and bleeding. ITP is secondary to the destruction of circulating~     platelets through an auto-immune process and to a decrease of platelet production in bone~     marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed~     by platelets. The destruction of the platelets seems to occur mainly in the spleen through~     antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets~     participate to the platelet destruction through the CD16, the low affinity receptor for the~     Fc of IgG. Thus the CD16 pathway is a target for treatments in ITP as for example~     intravenous immunoglobulins and more recently inhibitors of the syk kinase.~   "
143817|NCT01172171|"~     In Denmark, 12.000 people a year, is struck by acute myocardial infarction. A third of these~     cannot be saved before treatment is possible.~      Despite quick and effective reperfusion of the coronary arteries using PCI (Percutaneous~     Coronary Intervention) after an acute ST-elevation myocardial infarction, substantial~     morbidity and mortality remain. Infarct size is an important determinant of the short-and~     long-term outcome after acute myocardial infarction. The most widely used and most effective~     proven therapy to limit infarct size is the early reperfusion induced by or PCI.~      Although beneficial in terms of myocardial salvage, reperfusion itself may contribute to~     additional damage of the myocardium; the damage due to the combined processes is known as~     ischemia-reperfusion injury. The pathogenesis of myocardial ischemia-reperfusion injury is~     a multifactorial process involving the interaction of multiple mechanisms. Numerous studies~     indicate that there are three pivotal factors in the pathogenesis of ischemia-reperfusion~     injury: elevated oxidative damage, depressed energy metabolism, and altered calcium~     homeostasis.~      Partially reduced species of oxygen, including the superoxide anion radical, hydroxyl~     radical, and hydrogen peroxide, are generated intracellularly as by-product of oxygen~     metabolism. These reactive oxygen species cause peroxidation af membrane lipids,~     denaturation of proteins, and modification of DNA, all of which ultimately can lead to cell~     death. In mammals, cell damage induced by partially reduced oxygen species can also initiate~     local inflammatory responses, which then lead to further oxidant-mediated tissue injury.~      Melatonin is mainly known for its role as an endogenously produced circadian hormone.~      For the last twenty years, increasing evidence has proven melatonin to be a very potent~     direct and indirect antioxidant.~      Recent experimental studies have documented the beneficial effects of melatonin in reducing~     tissue damage and limiting cardiac pathophysiology in models of experimental~     ischemia-reperfusion.~      Primary hypothesis: Melatonin given to patients undergoing PCI can reduce the myocardial~     damage sustained by ischemia-reperfusion.~   "
143818|NCT01172158|"~     Ureteral stents has become an indispensable instrument for urology practice as a result of~     widespread use of endourological interventions. Removal of stents could be sometimes~     neglected by patients or physicians. This omission may lead to legal and medical problems~     for urologists, health institutions and also for patients. In this study, the investigators~     offer a computer program providing two sided recall to prevent this nasty complication with~     sending automatic message by short message service (SMS) to both the patient and the~     urologist.~   "
143819|NCT01172145|"~     This study examined the effects of modafinil on apathetic symptomatology, performance of~     activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's~     disease (AD).~   "
143820|NCT01172132|"~     The purpose of this study is to determine:~        -  Condition of intensive care unit (ICU) admission in patients with haematological~          malignancies.~        -  ICU hospital and up to one year mortality.~        -  Assessment of post ICU burden and health related quality at 90-d and 1 year.~   "
143821|NCT01172119|"~     Prospective, multi center, randomized, single blinded study designed to demonstrate the~     safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery~     System at multiple time points compared to the Taxus Liberte DES in the treatment of single~     de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.0 mm and ≤ 14~     mm in length.~   "
143822|NCT01172106|"~     There is currently no clear involvement of families/caregivers in the care for postpartum~     mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum~     psychosis may influence the nature of perceived social support that mothers receive from~     caregivers. It is hoped that the provision of a culturally adapted version of family~     psychoeducation will bridge the knowledge gap and provide the much needed information. We~     therefore hypothesized that the involvement of a family member of a postpartum mother with a~     psychotic illness in a weekly session of family psychoeducation.~   "
143823|NCT01172093|"~     OSA is prevalent among patients with type II DM~   "
143824|NCT01172080|"~     Although systems are in place to ensure results of tests are communicated to patients, there~     is currently no generalized accepted strategy to ensure that patients undergo recommended~     follow-up testing. When follow-up tests are recommended months to years into the future,~     there is a high likelihood that the test will either be delayed or not performed resulting~     in the potential for poor outcomes and litigation. For this reason, there is a clear need~     for systems to be developed which automatically trigger patient communication when the date~     of a recommended follow-up test is approaching. The investigators propose to design a~     protocol for ensuring that patients are reminded to schedule follow-up tests and that this~     communication is documented in the online medical record. This work will provide the~     foundation for the creation of systems that significantly improve patient care, and can be~     easily adapted for use in many clinical departments and institutions.~      Aim 1. To use patient focus groups to help design a system for improving adherence to~     endoscopy follow up recommendations~      Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the~     system on a cohort of patients due for a surveillance colonoscopy.~   "
143825|NCT01172067|"~     The purpose of this study is to demonstrate that QuickOpt optimization can be as an~     alternative method for CRTP/D patients' optimization in clinical practice through the~     comparison of the improvement differences between the CRTP/D patients with different~     optimization at 12 months after implantation.The hypothesis is that the Heart Remolding~     parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after~     implant is not inferior (10%) to the patients by Echo optimization。~   "
143826|NCT01172054|"~     This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity~     and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as~     a single dose vaccination on day 0.~   "
143827|NCT01172041|"~     This study will investigate whether audiovisual biofeedback, in which visual and audio cues~     are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D~     PET scans.~   "
143828|NCT01172028|"~     RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells of by stopping them from dividing.~     Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~      PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed~     disodium and docetaxel together in treating patients with advanced solid tumors.~   "
143830|NCT01172002|"~     Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis~   "
143831|NCT01171989|"~     The current trial will evaluate the safety and immunogenicity of GSK Biologicals'~     GSK2202083A vaccine when administered as a booster dose following priming in the first year~     of life with the same vaccine.~      This protocol posting deals with objectives & outcome measures of the booster phase. The~     objectives & outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00970307).~   "
143835|NCT01171937|"~     The proposed study attempts to deepen our understanding of repetitive behaviors in autism~     spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits~     associated with risperidone treatment using functional MRI. This study is a substudy of a~     larger center grant (IRB#07-03-066). Other studies also under this center grant, include:~     IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another~     sub-study, should they meet criteria. The proposed study will address this aim by mounting a~     controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment,~     children will enter a three-part study. Phase 1 will be an 8-week, double-blind,~     placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week~     open-label maintenance phase for responders to risperidone or placebo. Non-responders to~     placebo will be invited to enroll in the eight-week open-label study. 48 of the participants~     will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The~     medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to~     4.0mg.~   "
143836|NCT01171924|"~     This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head~     and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a~     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human~     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is~     designed to compare the safety and tolerability of CUDC-101 when administered at the maximum~     tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.~   "
143837|NCT01171911|"~     Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial~     shear stress is predictive factor of clinical outcomes in patients with obstructive~     stenosis.~      The present study aims at comparing the re-distribution of shear stress and blood velocity~     during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.~   "
143838|NCT01171898|"~     The purpose of this study is to assess the safety and activity of ARN-509 in men with~     advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1~     of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase~     2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of~     ARN-509.~   "
143839|NCT01171885|"~     The objective of this study is to compare the postoperative analgesia afforded by bilateral~     superficial cervical block using different concentrations of local anesthetic (ropivacaine)~     in patients undergoing total thyroidectomy for the mini-incision technique, performed by the~     same surgical team.~   "
143840|NCT01171872|"~     The causes of inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis~     (UC), are unknown and diagnosing them is often difficult. This research is being done to~     find the genes that may increase the risk of inflammatory bowel disease, and to identify~     specific protein substances that are related to IBD. The investigators are also looking at~     cell factors that may predict response to treatment for IBD. In IBD, cells of the~     gastrointestinal tract (your gut) do not seem to respond to certain substances in a normal~     way. Scientist have discovered that the immune system, made up of cells and chemicals that~     defend your body from infections, is working in a way that damages the walls of the gut. You~     are being asked to join in this study because you are going to have an surgical procedure~     performed related to your diagnosis of Crohn's disease or ulcerative colitis or for other~     medical reasons (for comparison purposes). If you join this study, the investigators will~     study the cells in the resected tissue from your gut to find out why some cells do not act~     in the normal way in people with IBD as compared to people without IBD. The more the~     investigators understand about how differently these cells are working, the better doctors~     and scientists will be able to someday help people with IBD.~   "
143841|NCT01171859|"~     This study is being conducted to explore the potential benefits of a twelve-month~     doxycycline (at the best tolerated dose of 200 mg/day) and tauroursodeoxycholic acid (750~     mg/day) treatment on disease progression in patients affected by transthyretin amyloidosis,~     including: 1) patients not eligible for liver transplantation; 2) patients eligible for~     liver transplantation, as a bridge therapy between the time of diagnosis and surgery, with~     the aim of stabilizing the disease; 3) patients showing disease progression after liver~     transplantation performed since at least 1 year.~      It is a phase II, therapeutic exploratory, two-part, 18-month, single centre, prospective~     study.~      Part I is a 12-month, open label treatment period in which doxycycline (200 mg/day,~     continuously) and tauroursodeoxycholic acid (750 mg/day continuously) are administered to 40~     consenting subjects with transthyretin amyloidosis. Part II is a withdrawal period in which~     subjects will be monitored for disease progression. During part I, subjects will be~     evaluated at baseline (study Day 0), and then after 3, 6, 9 and 12 months of doxycycline~     plus tauroursodeoxycholic acid treatment or at premature treatment discontinuation; during~     part II, they will be assessed at months 15 and 18. Monthly phone contacts and blood tests~     will be performed to monitor potential adverse events.~   "
143842|NCT01171846|"~     Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the~     vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by~     other organs moving down from their normal position in the pelvis and pushing into the~     vagina. This is a very common problem and many women who have given birth will have a very~     mild bulge which does not cause them symptoms. Women can however experience a variety of~     pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies~     have properly examined whether or not exercises can prevent prolapse. This study aims to~     explore whether exercises taught by a physiotherapist can prevent women developing a~     prolapse which requires them to have treatment.~   "
143843|NCT01171833|"~     Three groups of patients are going to have minor surgery under general anesthesia with~     inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg,~     respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B~     (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be~     observed differences among the groups for ventilatory effects on speed of induction.~      Duration of this randomised controlled trial will be about 3 months. Estimated sample size~     will be 36 patients(12 in each group).~   "
143844|NCT01171820|"~     The purpose of this Clinical Evaluation is a continuation in the assessment of the~     performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in~     the treatment of patients with de novo coronary artery lesions in patients (Diabetic~     sub-study).~   "
143846|NCT01171794|"~     This is a research study on Altitude Illness. From the information collected and studied in~     this project we hope to learn more about Altitude Illness, including factors that may affect~     and prevent the development and progression of this condition. We hope to learn if the~     commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude~     illness. Possible participants in this study are healthy adults who indicated they would~     like to participate, learn about altitude illness, and desire to hike Barcroft Peak.~     Stanford University researchers hope to enroll about 100 participants.~   "
143847|NCT01171781|"~     The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe~     based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal~     carcinoma~   "
143848|NCT01171768|"~     Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of~     angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF~     levels have been reported in inflammatory lung diseases, especially with hemoptysis, there~     was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the~     presence of hemoptysis, inflammatory biomarker and hypoxia.~   "
143849|NCT01171755|"~     In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy~     in advanced BTC.~   "
143850|NCT01171742|"~     Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and~     effective procedure for major hepatectomy in patients with liver disease. In addition,~     ischemic preconditioning with IHIO has been reported to have protective effects in patients~     undergoing liver resection. The role of IHIO, however, has not been fully elucidated in~     donors and recipients during living donor liver transplantation.~   "
143851|NCT01171729|"~     This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in~     men with hormone-Refractory Metastatic Prostate Cancer.~   "
143852|NCT01171716|"~     the purpose of this study is to identify how the body responds to increased dietary protein~     (that includes pork and eggs) and meal-frequency in adult men. During this study, the~     changes in blood glucose, hormones, appetite, and energy expenditure will be examined.~   "
143853|NCT01171703|"~     The purpose of this trial is to find out the appropriate way to treat DM patients with~     critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of~     femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.~   "
143854|NCT01171690|"~     This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the~     setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that~     teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in~     patients with symptomatic hypoparathyroidism.~   "
143855|NCT01171677|"~     Addiction to illicit and prescribed drugs, alcohol and tobacco is associated with a panoply~     of brain changes that contribute to structural and micro-structural deficits, altered~     metabolism and neurotransmission, and related cognitive deficits affecting executive~     function, decision-making, reward salience and motivation. Many of these deficits may act as~     barriers to recovery, compromising the same spectrum of cognitive processes that established~     interventions (motivational enhancement, cognitive behavioral therapy, therapeutic~     communities, etc.) depend on for successful outcomes. Even where there are medications that~     target a specific addiction (e.g., methadone for opiates), meaningful, sustained recovery~     relies on the acquisition of adaptive skills and strategies. As such, there is a need to~     develop interventions for substance use disorders that have the potential to improve health~     and cognitive and psychosocial functioning, and to be embraced by the treatment community. A~     growing body of basic and clinical research suggests that physical exercise may reduce drug~     use and improve cognitive-executive function, mood, and motivation. There is also a growing~     literature on the effectiveness of positive affirmation as a cognitive-behavioral~     intervention for depression and PTSD both of which frequently co-occur with addiction.~     Building on this, we hypothesize that a combined exercise and affirmation intervention~     (IntenSati) will lead to improved cognitive and psychosocial function. To test this, we~     propose to conduct a two-arm randomized clinical trial - in adult volunteers with a history~     of longstanding substance use and who are in treatment in a residential therapeutic~     community setting (Odyssey House) - to examine cognitive and psychosocial function before,~     during, and after randomization to either a twelve-week IntenSati intervention condition or~     to a twelve-week no-exercise/no-affirmations control condition. This is a pilot study~     intended to collect data on feasibility and effect size. The population and sample size were~     selected on the basis of likelihood to benefit from the intervention, likelihood for good~     adherence, and the realities of completing a low-cost pilot study within a one-year~     timeframe. Overall there were no substantial differences between IntenSati and TAU on~     measures of cognition, mood, and psychosocial functioning. Limitations include the small~     sample size, limited exercise intensity and capacity, missed exercise classes, dropout~     because of placement, work schedules and non-study-related medical conditions.~   "
143856|NCT01171664|"~     To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom~     scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on~     placebo.~   "
143857|NCT01171651|"~     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594~     (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib~     therapy.~   "
143858|NCT01171638|"~     This is a prospective observational study to determine the reliability and accuracy of Near~     Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and~     non-injured soldiers over time. This technology may be useful in the detection of acute~     compartment syndrome. We hypothesize that:~        -  NIRS values will be well-correlated with intracompartmental pressure measurements~        -  NIRS values will be significantly different between non-injured and injured~          extremities, and injured extremities treated with fasciotomy for acute compartment~          syndrome.~        -  NIRS values of the upper extremity and feet will correlate to values from normal legs~          in critical control patients and patients with unilateral sever lower extremity~          injuries.~   "
143859|NCT01171625|"~     The purpose of the study is to demonstrate the long term safety and effectiveness of the~     Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve~     replacement with or without concomitant procedures requiring cardiopulmonary bypass.~   "
143860|NCT01171612|"~     The purpose of this study is to evaluate and monitor perioperative management of patients~     with coronary stents undergoing noncardiac surgery.~      Objectives:~        -  To describe the incidence and severity of adverse cardiovascular events in patients~          with coronary stents undergoing noncardiac surgery with admission.~        -  To assess the following-up of the guidelines about the perioperative management of~          antiplatelet therapy in these patients.~        -  To assess the relationship between the incidence of cardiac or neurovascular events, as~          well as bleeding complications with the perioperative management of antiplatelet~          therapy.~        -  Number of Participants with Adverse Events as a Measure of Safety~   "
143911|NCT01170988|"~     Is the surgical treatment of patients with coronary heart disease using the T-graft~     technique an adequate solution that provides a sufficient myocardial flow reserve? A~     magnetic resonance examination (MRI) is required.~   "
143862|NCT01171586|"~     The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to~     develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight~     or moderately obese English and Spanish speaking adults ages 21 - 60. The investigators~     propose that participants randomized to the intervention arms will lose significantly more~     weight than those participants randomized to the control group.~   "
143863|NCT01171573|"~     Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)belong to a group~     of inflammatory muscle disorders, of unknown cause, that are characterised by skeletal~     muscle inflammation and progressive muscular weakness, which can be debilitating and chronic~     in nature (occasionally fatal).~      The current treatment options for these conditions are steroids and various other~     immunosuppressive drugs. However, these are usually only partially effective at reducing~     symptoms, and their toxic side effects also limit their usefulness. In order to develop more~     specific treatments for myositis in the future (and therefore more effective), it is~     important to understand the exact mechanisms that cause the disease in the first instance.~     In other similar inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus~     (SLE), it is known that changes to the Human Leukocyte Antigen(HLA), as well as certain~     inflammatory cytokines, are involved in both the development and expression of the disease.~      As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to~     those in RA and SLE, it seems likely that similar genetic factors will also be involved in~     the development and expression of PM, DM and IBM.~      In order to understand the genetic aspects / causes of myositis, and ultimately develop more~     effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to~     give 20 mls of blood. These blood samples, along with the patient's clinical details, will~     then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The~     University of Manchester, where all of the genetic analyses will take place. By~     understanding the genetic cause of the disease, it should be possible to design specific~     drugs for treating the condition in the future.~   "
143864|NCT01171560|"~     In anesthetized patients the airway needs to be secured due to lack of protective reflexes.~     Golden standard is the endotracheal intubation. In patients undergoing lung surgery single~     lung ventilation is essential. In these cases a double lume tube is commonly used. The~     double lume tube has a proximal tracheal and a distal bronchial end reaching into the left~     or the right side of the lung dependant of the model of the tube. Thus it is possible to~     operate on one collapsed side of the lung while ventilating the other side.~      Due to length and stiffness resulting of the construction of the device more side effects~     than after intubation with a conventional single lumen tube is expected. Possible side~     effects may be bleeding, swelling, sore throat or croakiness.~      The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a~     device placing a balloon into one bronchus to be able to provide single lung ventilation~     like the double lume tube. However, the EZ-Blocker is a catheter pushed through a~     conventional single lume tube after intubation with a hook on one and a balloon on the other~     distal end. The hook prevents the device from being pushed too far to be able to harm the~     lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with~     the balloon. The device is easily positioned using a bronchoscope and when the~     anaesthesiologists confirmed the correct position of the device, the balloon can be inflated~     and deflated as needed.~      Due to the easier approach the investigators expect less side effects as mentioned earlier~     using the EZ-Blocker compared to the double lume tube. As well the stress caused by~     intubation may be reduced.~   "
143865|NCT01171547|"~     The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with~     suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous~     hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation~     for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.~   "
143866|NCT01171534|"~     Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often~     require multiple returns to surgery for closure, and occasionally require skin grafting~     (i.e. they are never completely closed). We are interested in seeing whether this device,~     which provides constant and gradual tension on the wound, may allow for rapid wound closure~     in a safe fashion, perhaps even precluding a return trip to surgery.~      Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc,~     Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than~     standard vessel loop techniques.~      Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of~     return trips to the operating room for surgical procedures related to closure or skin~     grafting of fasciotomy wounds.~   "
143867|NCT01171521|"~     Complex wounds that cannot be closed primarily are at great risk for complications. A new~     technique utilizing external tissue expansion holds promise in rapidly decreasing wound~     area. Facilitation of rapid wound closure is critical in preventing wound complications.~      Hypothesis:~      Using the Dermaclose Wound Management System (Woundcare Technologies, Inc., Chanhassen, MN)~     in complex wounds not able to be primarily closed will decrease the time to secondary~     closure and decrease the need for secondary soft tissue coverage procedures, or if secondary~     soft tissue procedures are required, its use will decrease the size and complexity of the~     secondary soft tissue procedures.~      Null Hypothesis:~      The Dermaclose system will not decrease the need, dimensions, or complexity of secondary~     soft tissue coverage procedures in complex wounds not able to be primarily closed.~   "
143868|NCT01171508|"~     The purpose of this study is to investigate circadian disturbances after breast cancer~     surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite~     of melatonin in urine and by questionnaires and a sleep-diary.~   "
143869|NCT01171495|"~     Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve,~     asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.~   "
143870|NCT01171482|"~     The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in~     HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with~     locoregional therapies.~   "
143912|NCT01170975|"~     This study explores the effects of food (a high-fat meal) on the pharmacokinetics of~     tesetaxel.~   "
143913|NCT01170962|"~     The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a~     and ribavirin can result in higher cure rates in patients who previously failed therapy and~     may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.~   "
143871|NCT01171469|"~     This is a single center Phase I study to determine the safety and maximum tolerated dose~     (MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells~     administered as a vaccination in children and adults with recurrent brain tumors. Once the~     MTD has been determined, we will conduct a phase II study to determine efficacy.~      Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival~     benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately,~     at the present time the majority of tumor patients are unable to mount an adequate immune~     response and thus succumb to their tumors. We postulate that the inability to generate an~     appropriate immune response in these patients is due to a lack of sufficient numbers of~     appropriate T cells due to an inadequate source of tumor antigens.~   "
143872|NCT01171456|"~     Gestational diabetes (GDM) represents a significant and growing source nationwide of~     morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are~     complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased~     risk of neonatal complications as well as an increased prevalence of a number of chronic~     diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment~     with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and~     effective. Additional studies demonstrated that metformin is able to decrease the incidence~     of type 2 diabetes among individuals at risk for this disease. Based upon these findings,~     the investigators propose to test the hypothesis that metformin therapy for women at risk~     for gestational diabetes, started prior to conception and before the onset of hyperglycemia,~     both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.~      The investigators intend to conduct a prospective, randomized, double-blind placebo~     controlled range-finding study to measure the effects of early metabolic intervention with~     metformin in women at risk for GDM before the commencement of pregnancy or prior to~     completion of the first trimester. The target sample size for this pilot study is 100 women.~     The effect size observed will provide preliminary data for a subsequent study which will be~     sufficiently powered to detect small or moderate effects from early metabolic intervention~     in women at risk for GDM.~      The specific aims of the proposed research consist of the following:~        1. Determine whether treating women at risk for GDM with metformin prior to conception~          and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks'~          gestation.~        2. Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception~          metabolic intervention with metformin in women at risk for GDM.~        3. Use these pilot study results to:~             1. identify specific demographic characteristics associated with an intervention~               effect~             2. calculate effect size for specific outcomes~             3. provide range-finding data for a subsequent study design~      Metformin therapy for women at risk for gestational diabetes, started prior to conception~     and before the onset of hyperglycemia, both decreases the incidence of and improves the~     maternal and neonatal outcomes from GDM.~   "
143873|NCT01171443|"~     Since the pathophysiology of BIPN still remains unclear, in the present study we are going~     to assess the development of BIPN in newly diagnosed myeloma patients, based on clinical~     neurological examination and electrophysiological study (EMG) and trying to find out if~     there is any relationship between oxidative stress generation measured by serum~     malonyldialdehyde - (MDA) and urinary isoprostane, and the development of BIPN, which can~     explain important part of the BIPN pathophysiology and can suggest new ideas of treatment~     and prophylactic strategies of peripheral neuropathy.~   "
143874|NCT01171430|"~     The main objective of this study is to examine if absence of a satisfactory response on~     DCE-WB-MRI (see MR criteria of responders section) after completion of HDT followed by~     autologous stem-cell transplantation (ASCT) is an independent prognostic factor for EFS in~     patients with MM, compared with established ones including beta2-microglobulin and~     cytogenetic abnormalities. Secondary objectives are to examine if the microcirculation~     parameters obtained from baseline DCE-WB-MRI have prognostic significance and to examine if~     early DCE-WB-MRI performed after the induction HDT and before ASCT might also provide~     independent prognostic information for patient outcome, which might help in patient~     stratification and be integrated into the response criteria in the future.~   "
143875|NCT01171417|"~     For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to~     Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line).~     For all patients, to collect and explore real-life data on the epidemiology and management~     of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with~     Faslodex 500 mg or exemestane.~   "
143876|NCT01171404|"~     The aim of this international study is to describe the short- and long-term (i.e. up to 2~     years following the index event) antithrombotic management patterns (AMPs) in patients~     hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction~     (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the~     impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life'~     setting and to compare these between sites, countries and regions.~   "
143877|NCT01171391|"~     The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of~     VA106483 in female subjects.~   "
143878|NCT01171378|"~     The purpose of this study is to evaluate Ofatumumab in combination with CHOP~     (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and~     prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance~     treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to~     CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for~     Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's~     Syndrome (RS), shows a difference in overall survival (more people living longer), when~     compared with the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).~   "
143879|NCT01171365|"~     The purpose of this study is to determine whether an inhaled steroid with a small particle~     size can be an additional treatment option in patients with refractory eosinophilic asthma.~   "
143880|NCT01171352|"~     Currently, decisions regarding volume management for dialysis sessions in the ICU are made~     in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based~     upon a combination of commonly used measures of circulatory function, the physical exam,~     fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood~     volume status using devices such as the Crit-Line™ III, and central venous pressures.~     However, these tools perform poorly in predicting the circulatory system's overall response~     to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently~     encountered. Better techniques to predict the circulatory system's response to dialysis are~     much needed. The intent of this study is to test newer metrics of circulatory system~     function for their ability to predict low blood pressure episodes during dialysis. This is~     important because it may enable the design of newer treatment strategies created to prevent~     low blood pressure episodes during dialysis and improve patient outcomes. The investigators~     overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid~     responsiveness, previously found to better reflect cardiac preload state than currently used~     parameters, will better predict low blood pressure episodes during dialysis than current~     methods.~   "
143881|NCT01171339|"~     Objective: To investigate whether the complex intervention will improve the appropriateness~     of prescriptions in elderly multi-morbid patients with multi-medication in general~     practices.~      Study hypothesis: The primary objective of the study is to determine whether the complex~     intervention will improve the appropriateness of prescriptions compared to usual care. The~     primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score~     from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.~   "
143882|NCT01171326|"~     Impetigo is a common, highly infectious skin disease caused by bacterial infection and~     characterized by crusting skin lesions. It is most common in children, particularly children~     in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is~     caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which~     can also be isolated from impetigo lesions.~      This is a pilot phase II study to evaluate the tolerability and safety and to monitor the~     clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.~   "
143883|NCT01171313|"~     The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in~     comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after~     administration of XP21279/Carbidopa and Sinemet and to explore exposure-response~     relationships in a subset of subjects.~   "
143884|NCT01171300|"~     Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard~     in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by~     extensive surgery regardless of tumor response. The main question is whether extensive~     surgery can be avoided holding in mind that already a significant amount of patients reach a~     pathological complete response after radiochemotherapy. The goal of this study is dual.~     First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the~     assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select~     those patients eligible for less invasive surgery. In the same patient group, the~     investigators will examine the biomarker potential of molecular characteristics of the tumor~     in blood and tissue. Using both molecular and radiological findings, the investigators want~     to predict pathological response after chemoradiotherapy and to select patients who may~     benefit from treatment adjustments during chemoradiotherapy.~   "
143885|NCT01171287|"~     Research on the implications of orthopedic injury and surgery on automobile driving ability~     has been limited. Only a handful of orthopedic issues have been studied to date, especially~     the safe postoperative resumption of driving. However, effects of orthopedic immobilizations~     of the lower right limb on fitness to drive are largely unknown, and the physician is left~     with little guidance. Only one study (Tremblay et al. 2009) have looked at the impact of~     wearing such devices on braking performances. The results have shown a statistically~     significant increase of braking times while wearing a removable Aircast walker and a walking~     cast in healthy subjects under simulated driving conditions. Despite this, the study have~     not demonstrated that driving with orthopedic immobilization is dangerous since the increase~     in braking times were minimal. Limitations of this study include the important fact that~     driving simulation is not real-time driving. In order to assess the validity of the driving~     simulator used in this study, a similar experimental study during real-time driving was thus~     devised.~   "
143886|NCT01171274|"~     Hatha Yoga is a traditional system of exercises, used in India for the relief of painful~     condition since centuries and gaining more and more interest in Europe and the US. While~     studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no~     studies regarding chronic neck pain are available until now. The purpose of this study is to~     determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.~   "
143887|NCT01171261|"~     This is a RWJF funded study that will apply behavioral choice theory and learning theory~     principles to 'map' exergames to determine how behavior change principles influence~     sustained use of health games by adolescents.~   "
143888|NCT01171248|"~     The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP)~     in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation~     between central and peripheral 24 hour BP and a possible association to late complications~     in diabetes.~   "
143889|NCT01171235|"~     The aim of the study is to find for one or more serum or tissue markers of molecular biology~     in head and neck cancer patients used for early diagnosis, predicting prognosis and being~     sensitive to chemotherapy and radiotherapy~   "
143890|NCT01171222|"~     This study shall provide missing descriptive data on health status of veteran players and~     potential preventive effects of soccer at an age of 40 to 60 years. The investigation~     represents a cross-sectional examination of cardiovascular parameters and metabolic stress~     induced by training and competition. Additionally, orthopedic and other medical risks are to~     be revealed, and options should be developed to minimize these risks, e.g. by preventive~     measures included in training or rule modifications.~   "
143891|NCT01171209|"~     The purpose of the study is to determine if Interferon-alfa is effective and safe in~     multiple sclerosis patients who developed neutralizing antibodies for Interferon-beta.~   "
143892|NCT01171196|"~     The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore,~     tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective~     screening tools for Chinese subjects who are suspected to have obstructive sleep apnea~     (OSA).~   "
143893|NCT01171183|"~     This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine~     dependent participants.~   "
143914|NCT01170949|"~     Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on~     skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is~     defined by insufficient treatment response after a minimum of 1 week therapy with the~     maximum labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at~     baseline 8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to~     one of the following treatment groups as add-on to the ongoing therapy with a non-sedating~     antihistamine for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and~     safety evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of~     treatment) and at day 56 (28 days after end of treatment).~   "
143894|NCT01171170|"~     This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery~     25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous~     non-small cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab,~     followed by bevacizumab alone until disease progression. Tumor hypoxia is a common~     phenomenon in lung cancer; it is a known poor prognostic marker, related to treatment~     resistance. Pre-clinical studies have shown that nitric oxide (NO) donating drugs may~     decrease hypoxia related drug resistance. NTG is a NO donating drug. NTG increases tumor~     blood flow and thereby augments antitumor drug delivery to the tumor.~      A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG~     patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with~     advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.~      The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab~     containing chemotherapy improves progression free survival, response rate and overall~     survival in patients with metastatic non-squamous NSCLC.~   "
143895|NCT01171157|"~     The purpose of this research study is to estimate how many elderly people who have symptoms~     that look like influenza (i.e. an influenza-like illness) actually have the disease and how~     effective influenza vaccines are in preventing influenza in elderly people. The study will~     also examine the severity of the disease (e.g. how long are people ill, were there any~     complications) and how it affects everyday life (e.g. cost, medications, care by family~     members).~   "
143896|NCT01171144|"~     This study aims at collecting data from secondary sources to obtain baseline incidence and~     monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis~     related hospital discharges and gastroenteritis related deaths in children < 5 years of age~     in Panama before and after implementation of Rotarix™ universal mass vaccination.~   "
143897|NCT01171131|"~     The aim of this research is to determine if the biological fluids (blood/saliva) from~     chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible~     protein markers. To accomplish this two populations of chronic TBI patients who are~     receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury~     victims and non-penetrating TBI will be studied. Using multiple proteomic approaches~     including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA~     profiling, the investigators aim to identify biomarkers in the blood/saliva of patients~     suffering from chronic TBI and to determine the similarities/differences between the blast~     and non-penetrating injury groups. Identification of these biochemical changes will give~     insight into the long-lasting changes associated with head injury, and may identify new~     targets for treating the associated pathologies.~   "
143898|NCT01171118|"~     The investigators are attempting to demonstrate a decrease in the frequency and severity of~     sedation-induced respiratory arrhythmias(central and obstructive apneas) with~     pharmacological pre-treatment in this pilot project and then eventually to understand the~     mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while~     evaluated during sleep in Obstructed Sleep Apnea (OSA) patients, have not been~     systematically studied during sedation in either normal subjects or OSA patients. The agent~     to be assessed in this study in physostigmine versus placebo.~   "
143899|NCT01171105|"~     1. The main purpose of this study is to assess the safety and tolerability of AZD5213~          after multiple oral doses.~        2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how~          the study drug enters and leaves your body and how your body acts on the study drug) of~          AZD5213 in your blood and urine.~   "
143900|NCT01171092|"~     The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe~     and effective in blood cell mobilization.~   "
143901|NCT01171079|"~     The purpose of this study is to evaluate the effects and safety of oxidized, regenerated~     cellulose as an absorbable adhesion barrier after thyroidectomy.~   "
143902|NCT01170026|"~     This application will provide a test of one potential model for adding substance use~     assessment and brief intervention into a truancy court program. The primary goal of this~     study is to determine whether a motivational intervention will reduce substance use among~     adolescents referred to truancy court for school attendance problems. In this treatment~     development application, an open trial with 20 families referred by truancy court will first~     be conducted. This trial will be used to adapt an existing motivational intervention to~     include material relevant to school attendance and performance. Then 100 families~     participating in the Rhode Island Truancy Court Program with adolescents between the ages of~     13-16 years who report using substances will be randomly assigned to receive the~     experimental intervention plus standard truancy court procedures or psychoeducation plus~     standard truancy court procedures. The 2-session intervention protocol consists of an~     individual motivational interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a~     family based motivational interview. The experimental protocol provides a thorough~     assessment of both individual and family strengths and weaknesses with respect to substance~     use prevention and school attendance/performance. Follow-up interviews will be conducted at~     3 and 6 months.~   "
143915|NCT01170936|"~     This is a single-center open label study to assess the efficacy and safety of single doses~     of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes~     IL-1β, in patients with active urticarial vasculitis. Efficacy is primarily assessed by a~     combined symptom score, the urticarial vasculitis activity score (UVAS). Following a~     baseline period of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg~     (consistent with a total dose of 300 mg canakinumab). Visits for investigator's assessments~     will be scheduled at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose.~     Patient's self-assessment will be performed on a daily basis throughout the study. Overall a~     max. of 10 subjects with urticarial vasculitis will be enrolled.~   "
143916|NCT01170923|"~     The usual response to chemotherapy is decided through the image change by computed~     tomography (CT), which is taken at least 6-9 weeks.~      In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at~     the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by~     FDG-PET scan.~   "
143988|NCT01169922|"~     This research is examining how genetic and brain factors play a role in adolescents' health~     risk behavior as well as studying behaviors that young people engage in that may place them~     at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of~     educational program works best to reduce these risky behaviors.~   "
143903|NCT01170013|"~     The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of~     long-range problems. This association persists despite changes in national substance use~     rates over time, indicating its stability and viability as a target for prevention. At the~     same time, parent monitoring of youth behavior tends to decrease during the adolescent~     years, creating a source of risk for not only the early onset of AOD use but also~     escalation. Thus, programs are needed in parenting behaviors and family relationships that~     are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse.~     This is particularly true of children with psychiatric disorders who are at higher risk for~     developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of~     this study is to test the effectiveness of a family-centered intervention to reduce the risk~     of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In~     this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use~     but have been referred for mental health care due to psychiatric symptomatology, will be~     randomly assigned to receive either an individually tailored family program or standard~     care. The experimental intervention, which is based on the Family Check-Up model (Dishion &~     Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they~     relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes~     principles of motivational interviewing to encourage families to change. Follow-up~     interviews will be conducted at 6 and 12 months after baseline to assess changes in~     parenting, AOD use, and other risky behaviors.~   "
143904|NCT01170000|"~     A national priority for health care providers is to initiate early communication about~     palliative and end-of-life care (PC/EOL) for children with a poor prognosis. Communication~     about prognosis and advanced care planning is critical to empowering parents to make~     decisions about PC/EOL for their children. A single-group study to refine and pilot test a~     PC/EOL communication intervention is entitled, Communication Plan: Early through End of Life~     (COMPLETE). COMPLETE is designed to be delivered during parent meetings and features: (a) a~     physician-nurse (MD/RN) team approach to PC/EOL communication; (b) printed visual aids and~     parent resource forms; and (c) hope and non-abandonment messages tailored by a MD/RN team to~     their communication style and parental preferences for information. During Phase I, an~     interdisciplinary approach involving nurses, physicians, PC/EOL expert consultants, and~     bereaved-parent consultants met to develop a standardized protocol and training procedures.~     During Phase II, this protocol will be evaluated with 24 parents and MD/RN teams. The~     investigators will evaluate parental outcomes regarding the COMPLETE's influence on: (a)~     information needs, emotional needs/resources, appraisal of MD/RN information and of symptom~     management; and (b) parental distress, uncertainty, decision regret, hope, satisfaction with~     MD/RN communication, and advance care planning over time. Findings from this study address~     NIH priorities related to: 1) an underserved population (i.e., parents of children with~     brain tumors); 2) an under-examined ethical concern about early integration of PC/EOL~     communication for parents of children with poor prognosis; 3) improved communication about~     PC/EOL among physicians, nurses, and parents; and 4) the potential for changing health care~     practice.~   "
143905|NCT01169987|"~     This observational study will document to what extent in daily clinical practice Humira~     (adalimumab) therapy is continued, interrupted or permanently discontinued during a~     follow-up period of 2 years. Reasons for interrupting or permanently discontinuing Humira~     therapy and reasons for restarting Humira therapy will be noted. An evaluation will be~     performed of the effect of the disease on quality of life and work productivity.~   "
143906|NCT01169974|"~     The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for~     the measurement of cutaneous blood flow following various durations of tourniquet ischemia.~   "
143907|NCT01171053|"~     The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT~     treatment for patients diagnosed with IBS. The patients' work with the treatment and is~     supported through online contact with a therapist.~      Approximately 86 patients will be included in the study and randomized to either condition.~      All included patients are assessed one week before the treatment starts. After 10 weeks~     (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after~     treatment.~      Patients in treatment condition are hypothesized to experience significant reduction IBS~     symptoms, societal costs and quality of life compared to patients on waiting list.~   "
143908|NCT01171040|"~     Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart~     failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization~     and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides~     some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many~     articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity~     divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However,~     myocardial tissue Doppler only provides the information of regional myocardium, so patients~     with regional wall motion abnormality, as coronary artery disease, can't be assessed by this~     method without handicap. In addition, conduction disturbance, like bundle branch block, also~     influences the result of myocardial tissue Doppler. For resolving those problems, the~     investigators had designed a new global parameter to assess LVFP. In the investigators prior~     study, left atrial distensibility correlated logarithmically to LVFP in patients with severe~     mitral regurgitation and also in patients with acute myocardial infarction. Left atrial~     distensibility provided a new viewpoint to assess left ventricular diastolic function and to~     predict prognosis. This time, to extend left atrial distensibility to general population~     received echocardiographic examination for predicting prognosis is attempted.~   "
143909|NCT01171027|"~     This study is designed to be a United States multicenter prospective randomized controlled~     non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal~     Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in~     elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES~     cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic~     cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES~     cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical~     and administrative outcomes will be measured.~   "
143910|NCT01171014|"~     The purpose of this study was to investigate the dose response effect of Bifidobacterium~     lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.~   "
143917|NCT01170910|"~     Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to~     improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow,~     pressure, resistance index, venous effluent pH) are correlated with better recovery of renal~     function (without dialysis during the first week after transplant).~      Observation or Investigation Method Used :~      The study is multicenter, prospective, open, controlled and randomized:grafts are divided~     into two parallel groups:~        -  group 1 corresponds to a conservation of grafts in static incubation~        -  group 2 corresponds to conservation using a pulsatile perfusion machine~      Duration and Organizational Arrangements for Research :~      The total duration of the study is planned for 36 months. This duration includes:~        -  an inclusion period that will last 24 months,~        -  the follow-up of recipient patients from the day of transplantation until twelve months~          after the operation~   "
143918|NCT01170897|"~     This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic~     and pharmacodynamic study in patients with advanced solid tumors.~   "
143919|NCT01170884|"~     Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or~     Ocular Hypertension Subjects Treated with Xalatan®.~   "
143920|NCT01170871|"~     The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and~     Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the~     activity of this combination.~      This research study is for research participants who have confirmed metastatic or~     unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate)~     for which standard curative or palliative measures do not exist or no longer effective.~   "
143921|NCT01170858|"~     Peritoneal dialysis (PD) is an established dialysis modality in patients with end stage~     renal disease (ESRD). However, there is growing awareness of the deleterious effect of high~     glucose content in PD solutions on the peritoneal membrane over time (1). Accordingly,~     development of new solutions to minimize glucose-induced toxicity and/or containing an~     alternative osmotic agent to glucose such as icodextrin and amino-acid were developed.~     Icodextrin is a mixture of high molecular weight, water soluble glucose polymers isolated by~     fractionation of hydrolyzed cornstarch (2). Unlike glucose which is absorbed from the~     peritoneal cavity primarily by diffusion across the peritoneal capillary endothelium, its~     absorption occurs mainly due to convective fluid movement out of the peritoneal cavity via~     the lymphatics (2). As a result, relatively constant osmotic pressure is created by~     icodextrin, thus it can provide sustained ultrafiltration during the long dwell.~      A number of studies have reported that icodextrin-based solution provides various clinical~     benefits compared with conventional glucose-based solutions (3-7). In particular, icodextrin~     has been successfully used in the fluid management of PD patients (4-5, 7). However,~     excessive ultrafiltration may induce underhydration, resulting in faster decline in residual~     renal function. This concern was first raised by Konings et al (8). In this study, a greater~     fall in residual glomerular filtration rate (GFR) was observed in patients using icodextrin~     compared to those using 1.36% glucose solution. In contrast, contradictory findings were~     also reported from the two studies indicating that residual renal function can be preserved~     by icodextrin solution (4, 9). Although the mechanisms are not clear, possible explanation~     includes the presence of high-molecular-weight icodextrin metabolites in plasma, which in~     turn may increase plasma oncotic pressure and hence preserve plasma volume and renal~     perfusion as suggested by Davies et al (10). Such discrepant findings may be explained by~     differences in study design, baseline fluid status, and other factors affecting residual~     renal function during the study. In the study by Konings et al (8), the comparative solution~     was 1.36% glucose, whereas 2.27% glucose was used in the study by Davies et al (4).~     Therefore, it can be speculated that volume status might differ depending on different~     concentration of glucose solution, thus leading to conflicting results. Also, these two~     prior studies are limited by residual renal function as secondary outcome, a short follow-up~     duration (4 mo vs. 6 mo), and small number of patients (32 vs. 50).~      To further explore the effects of icodextrin solution on residual renal function, the~     investigators will conduct a multicenter prospective randomized controlled open-label trial.~     Briefly, incident or prevalent adult CAPD patients with residual urine volume > 750 ml will~     be included. Patients on APD will be excluded. After a 4-week screening period, patients~     will be randomly assigned to icodextrin or 2.5% glucose solution for the long dwell.~     Residual GFR and fluid status will be assessed at baseline, 6, and 12 months. Residual GFR~     will be calculated as an average of urea and creatinine clearance from a 24-hour urine~     collection. To assess fluid status, the investigators will use three different assessment~     tools; 1) echocardiography for measuring intra vena cava (IVC) diameter and left ventricular~     end diastolic diameter, 2) measurement of plasma atrial natriuretic peptide, 3) bioimpedence~     analysis. Primary outcome is residual GFR change at 1-year and secondary outcome is change~     of fluid status during the study period. Also, biochemical laboratory data such as~     hemoglobin, hsCRP, plasma osmolality, and lipid profile, peritoneal equilibration test,~     dialysis adequacy, and daily peritoneal glucose exposure will be monitored. At least 50~     subjects (a total of 100) would be required for each group to detect 50% difference of~     residual GFR between the two groups if type I error rate is 5% and type II error is 20%~     given 30% of drop-out rate during the study period.~      Preservation of residual renal function is of paramount importance because it is an~     independent risk factor of mortality in PD patients. In addition, achievement of adequate~     ultrafiltration is another crucial therapeutic goal to improve clinical outcomes in these~     patients. In this regard, if these two goals can be accomplished by icodextrin, it would be~     an ideal dialysis solution in PD practice. The investigators study will address this issue~     to answer the unresolved question on the effect of icodextrin on residual renal function.~   "
143922|NCT01170845|"~     A neutrophil elastase inhibitor may have effect on suppression of the lung injury after~     thoransthoracic esophagectomy. The investigators hypothesized that postoperative~     complication, particularly respiratory complication may be reduced by neutrophil elastase~     inhibitor after esophagectomy.~   "
143923|NCT01170832|"~     This proposal will test if, in patients with type 1 diabetes, wide blood glucose~     fluctuations lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN),~     and to impaired heart contractile (pumping) function and heart failure. It will also~     evaluate the natural history of heart failure and enhanced cardiac risk in patients with~     type 1 diabetes in the current standard of diabetes care.~   "
143924|NCT01170819|"~     To compare the efficacy of transcervical double balloon catheters versus controlled release~     dinoprostone vaginal inserts for pre-induction cervical ripening in term women with~     unfavourable cervices.~   "
143925|NCT01170806|"~     Obesity is a chronic condition with fat-rich diets playing a major role in its etiology.~     Pharmacological therapy has been proposed for weight loss and maintenance. This study aims~     to study the intestinal lipase blockade by partial inhibition of fat absorption after~     treatment with two commercials formulations of Orlistat.~   "
143926|NCT01170793|"~     In patients with MOH, we will evaluate the impact of educative telephone coaching on the~     number of days with headache over the month preceding the appointment. The educative~     coaching will be administered by a nurse, during a single phone call and prior to the~     medical visit~   "
143927|NCT01170780|"~     Does corticosteroid (dexamethasone) have an effect on the postoperative period after~     laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and~     convalescence. This randomized, double-blinded study compares dexamethasone versus placebo.~     The patients are recommended one day of convalescence. The medicine or placebo is given~     before operation. The patients fill out questionnaire before operation and three hours after~     operation and in the following three days. The patients also register when they return to~     normal activities and work.~   "
143928|NCT01170767|"~     Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly~     patients in industrialized countries. Neovascular or wet AMD, characterized by the~     presence of choroïdal neovessels, represents the most aggressive form of the disease. Its~     prevalence is 3.3% among patients older than 65 years in Europe, and increases with age.~      Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD~     have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do~     not have the market authorization for this indication. However, numerous publications of~     case series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.~      These conclusions have to be confirmed with a high level of evidence study. The aim of the~     GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12~     months of treatment with bevacizumab compared to ranibizumab on the visual acuity of~     patients affected by neovascular AMD.~   "
143929|NCT01170754|"~     A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for~     colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets~     Phosphosoda) are now used on a limited basis because of their known association with renal~     injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely)~     has been used for over two decades for colon cleansing. The mixture is not very palatable~     due to the electrolyte additives which include sodium sulfate.~      To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons~     worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not~     mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of~     Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done~     with this prep. Anecdotally there have been reports (case series) that it is far more~     palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed~     and therefore this is not surprising. The issue at present is that there has never been a~     blinded study to confirm these claims.~      This study will compare the efficacy of the two preps. There is no funding. The~     investigators will charge insurance companies for the prep - this is our current practice.~     The procedures will be done on healthy individuals referred for colon cancer screening and~     the exam will be billed to their insurance. There will be no patient honorarium. The~     investigators will check electrolytes to be sure patients do not develop hypokalemia with~     the Gatorade prep.~   "
143989|NCT01169909|"~     Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in~     pterygium, a neovascular disorder of the ocular surface.~   "
143990|NCT01169896|"~     Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)~     thérapies as a function of ventricular pacing~   "
143930|NCT01170741|"~     This study will draw from proven interventions to refine and pilot test a cue card driven~     computer-assisted intervention, along with HIV/STI testing, that will be tailored to each~     participant's demographic characteristics, risk behaviors, and biological test results. The~     specific aims of the proposed study are:~        1. To refine a cue card driven computer-assisted risk reduction intervention that will be~          tailored to each participant's demographic characteristics (e.g., gender, ethnicity),~          risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and~          herpes).~        2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g.,~          frequency of unprotected sex, condom use), drug use during sex and injection risk~          behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group~          randomized design that compares the tailored intervention with a delayed treatment~          control condition.~        3. To assess the feasibility and acceptability of the tailored intervention in a rural~          setting.~   "
143931|NCT01170728|"~     This study is a multi-center study that will assess the efficacy and safety of suture~     fixation of the Virtue® Male Sling.~   "
143932|NCT01170715|"~     Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the~     world's population. Severe psoriasis is a disabling disease affecting the physical and~     emotional well being of patients, and its effect on quality of life is similar to that seen~     with other major medical diseases such as diabetes, rheumatoid arthritis, and cancer.~     Lately, it is increasingly being recognized that psoriasis is not merely a skin disease but~     is probably associated with other co-morbidities such as psoriatic arthritis, Crohn's~     disease, the metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome~     is a combination of diabetes mellitus type II (or insulin resistance), hypertension, central~     obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides).~     As the literature linking psoriasis and the metabolic syndrome expands, also reports of an~     increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that~     metabolic dysregulations are the leading risk factors for occlusive vascular events and~     early death in patients with severe psoriasis. Progress in understanding the pathogenesis of~     these apparently diverse diseases has discovered that low-grade systemic inflammation might~     be the common physiological pathway that may provide the biological plausibility of the~     associations discovered in the epidemiological studies. Since some of these co-morbidities~     often become clinically apparent years after the onset of psoriasis we assume that~     controlling systemic inflammation might prevent or reverse some of these co-morbidities.~      Presently there is no study in psoriasis that shows that a systemic co-morbidity can be~     prevented or treated by reversing skin inflammation.~   "
143933|NCT01170702|"~     Since there have been no published dose-response studies investigating the effective~     analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia,~     the investigators propose a study primarily examining the effect on 24 hour post-Cesarean~     delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine,~     or 0.75% ropivacaine for TAP blocks.~   "
143934|NCT01170689|"~     This study is the first hospital-based, cross-sectional study to discuss the prevalence of~     obesity among 710 inpatients with schizophrenia.~   "
143935|NCT01170676|"~     This is a research study that compares the effectiveness of a web-based program (known as~     Puff City) and another web-based program (of internet sites such as the American Lung~     Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key~     asthma management issues among rural youth:~        1. Improving adherence to asthma controller medication use;~        2. Improving compliance of carrying a rescue inhaler at all times for use at the first~          sign of asthma symptoms;~        3. Improving inhaler technique;~        4. Smoking reduction or cessation in those who are smokers; and~        5. Avoidance of second-hand smoke exposure.~   "
143936|NCT01170663|"~     This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating~     the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP)~     compared to paclitaxel plus placebo.~   "
143937|NCT01170650|"~     The purpose of this study is to compare progression-free survival (PFS) (based upon~     investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian~     cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin~     (EC145+PLD) with that in participants who receive PLD and placebo.~   "
143938|NCT01170637|"~     The objective of the current study is to demonstrate bioequivalence of a fixed dose~     combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and~     RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and~     pseudoephedrine-HCl 30 mg following orally administration.~   "
143939|NCT01170624|"~     The purpose of this study is to evaluate the performance of advanced features, that have~     been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual~     Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities~     (PARADYM CRT System, model 8750) in a general ICD population.~   "
143940|NCT01170611|"~     This clinical investigation is a prospective, single-blinded, randomized trial. The primary~     objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive~     algorithms.~   "
143941|NCT01170598|"~     Fatigue, reduced quality of life and declines in physical function are common in patients~     undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients~     undergoing treatment have shown that exercise improves these symptoms, but there are limited~     studies in AML. This study of a hospital-based exercise program will help determine if~     exercise is both feasible and helpful in improving symptoms among for AML patients~     undergoing chemotherapy.~   "
143948|NCT01170507|"~     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of~     vitamin D status. The determination of the appropriate dose of vitamin D supplement is~     essential for management of vitamin D deficiency as well as for designing vitamin D~     fortification programs. The increments in 25 OH vitamin D levels following various doses of~     vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level~     have not been well defined. The time course of depletion of repleted vitamin D stores is~     also not known.~      The investigators plan to conduct a double blind randomized study on 9 cohorts to determine~     levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5~     months and their withdrawal for 3 months.~   "
143942|NCT01170585|"~     Systemic Lupus Erythematosus (SLE) is a condition that affects the whole body. It can cause~     inflammation of the blood vessels resulting in an earlier thickening and hardening of the~     arteries resulting in strokes. It has been reported that SLE can worsen the function~     resulting in heart failure.~      The aim of the study is to examine what effects Rosuvastatin, a cholesterol lowering drug,~     given to patients has on the degree of thickening of the arteries over the course of two~     years. We also want to see how it affects the function of the blood vessels and also of the~     heart.~      Individuals who agree to participate will be randomly assigned into two groups. One group~     will be given the active drug whereas the other will have a placebo. Subjects in the study~     will all have a cardiac magnetic resonance (CMR) scan before treatment, at 1 year and then 2~     years at the end of the treatment. Each scan will involve imaging the carotid arteries in~     the neck, the arteries in the arm and also the heart. Individuals will continue to have~     regular out-patient reviews by their own team of doctors, regular blood tests will be taken~     to monitor the disease and also to ensure the safety and well being of the individual.~      At the end of the 2 year study we hope that we will be able to slow down the rate of~     arterial thickening and retard any plaque build up in the arteries. We also want to see what~     effect rosuvastatin has on heart function. Ultimately, we hope to prove that people with SLE~     should be treated with a cholesterol lowering drug as part of their routine treatment.~   "
143943|NCT01170572|"~     Studies in chickens show that blood levels of a particular form of vitamin D (called~     24,25-dihydroxvitamin D) increase after bone fracture. Laboratory studies show that this~     form of vitamin D helps the bone healing process in chickens. The investigators want to find~     out whether blood levels of this form of vitamin D increase after bone fracture in humans.~     Previous research studies have not addressed this question. The results of this research~     could eventually lead to the development of new treatments to help bone healing after~     fracture.~      Patients will be asked to take part in this study if they are aged 16 years or older and~     come to the Royal London Hospital with a broken bone in the arm or leg or collar bone~     (clavicle). They will be asked to give a 20ml (about 4 teaspoons) blood sample on three~     occasions: at the start of the study, at 5-14 days after the fracture; and at 4-10 weeks~     after the fracture. The rest of their normal care would not be affected. Follow-up blood~     samples will be timed to coincide with routine clinic visits which are scheduled as part of~     normal clinical care. Patients' vitamin D level will be measured as part of the study, and~     those who have a low vitamin D level will be informed about this, and advised about~     appropriate vitamin D supplementation. The investigators will let the patient or their GP~     know if any blood tests are abnormal~   "
143944|NCT01170559|"~     Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and~     out-patient departments, specifically awareness of heart beats or palpitations. Unless an~     ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is~     having symptoms, it is very difficult to determine the cause of the palpitations. The~     conventional approach is to refer these patients from the emergency departments to the~     Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to~     record the rhythm underlying the patient's complaint. Unfortunately, this often yields no~     results thus delaying definitive treatment and incurring extra costs of repeated~     investigations and A&E presentations. This study aims to compare the ability of the~     conventional approach to establish a definite diagnosis compared to that of an early~     invasive monitoring approach with a small implantable device that records the heart rhythm~     at all time for up to 18 months.~   "
143945|NCT01170546|"~     Question: To investigate how different modes of thigh muscles strengthening exercises~     emphasizing the knee internal rotators can be as effective as possible in improving the~     static stability and agility of the knees with anterior drawer laxity.~      Design: Randomized controlled clinical trial.~      Participants and Interventions:~      Young men with anterior drawer laxity of the knee were randomly assigned to three~     experimental groups in different strengthening modes: plate-loaded squat press (SP),~     plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC).~     The control group with stable knees received no training.~      Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of~     this paper was to find out an optimal solution to the enhancement of the static and dynamic~     knee stability to a great extent.~      Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal~     rotator~   "
143946|NCT01170533|"~     Clopidogrel, in combination with aspirin, is currently the recommended treatment for~     secondary prevention of ischemic events in high-risk patients and for prevention of coronary~     artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated~     with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the~     risk of gastrointestinal bleeding, accorded to guidelines. An interaction between proton~     pump inhibitors and clopidogrel has been suggested, which may lead to a decrease of~     clopidogrel effects. It remains unclear whether this interaction between PPIs and~     clopidogrel might be a class effect or if this may be affected by timing regimen.~      The objectives of this two-phase investigation are:~        1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus~          separated at least 8 hours from omeprazole administration.~        2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus~          staggered at least 8 hours from pantoprazole administration.~   "
143947|NCT01170520|"~     The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and~     effective add-on therapy for resistent depression in adolescent patients.~      A group of adolescents suffering from non psychotic major depression that was resistant to~     at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed~     consent procedure for both parents and patients, patients will go through a clinical and~     cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using~     the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain~     interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.~   "
143991|NCT01169883|"~     Inner-city African American and Hispanic adolescents suffer from disproportionately high~     rates of emergency room visits and hospitalizations for acute exacerbations of asthma. This~     study proposes the use of a coping peer support intervention, enhanced by a technology-based~     platform that infuses peer support throughout adolescents' daily routines, to increase~     adherence to daily controller medications and ultimately reduce asthma exacerbation risk in~     this important population subgroup.~   "
143949|NCT01170494|"~     Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of~     vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or~     large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2~     compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining~     total 25 OH vitamin D level.~      The investigators plan to conduct a controlled trial to compare the effect of various~     vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH~     vitamin D level between 20 to 50 nmol/L.~   "
143950|NCT01170481|"~     Assessment of optic disc morphology can be difficult in patients with uveitis and~     papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning~     techniques may help to detect damage to the retinal nerve fibre layer.~   "
143951|NCT01170468|"~     Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status~     has been negatively associated with the presence of type II DM and glycemic control. A~     cause-effect relationship between vitamin D deficiency and the development of type II DM has~     not been established.~      The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled~     trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk~     individuals.~   "
143952|NCT01170455|"~     The purpose of this study is to determine whether nasal tracheal intubation using Blind~     Intubation Device is safe and effective in anesthetized patients with Mallampati class 3~   "
143953|NCT01170442|"~     Vitamin D status has been negatively associated with the presence of type II DM and glycemic~     control. However, a cause-effect relationship between vitamin D deficiency and glycemic~     control has not been established. The investigators plan to conduct a double blind,~     randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic~     control in Type II DM.~   "
143954|NCT01170429|"~     The purpose of this study is to investigate the efficacy and safety of procaterol~     hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma~     (CVA).~   "
143955|NCT01170416|"~     Patients sometimes suffer from life-threatening abnormal heart racing that originates from~     the lower chamber of the heart. These patients will often need an implantable defibrillator~     which has the ability to shock the heart back to a normal heart rhythm, but this does not~     prevent them from getting frequent recurrences of the bad heart rhythm needing shocks from~     the device. This can be painful and potentially harmful. Medicines to prevent recurrences of~     shocks are not very effective and have many side effects. An alternative to medicines for~     this is a procedure called a catheter ablation in which a wire is passed up through the~     blood vessels of the leg into the heart and used to find the short circuits which cause the~     dangerous heart rhythm. When the spot causing the trouble is found, the investigators can~     burn it (ablate it). This procedure is challenging and methods are needed to make it more~     effective and easier to do. One of the main ways for finding the short circuits involves~     using the electrocardiogram (the ECG). The regular ECG is simplistic and only makes use of~     recordings from 10 sites (6 precordial sites and 4 sites on both upper and lower limbs) on~     the body surface. The investigators are testing whether making recordings from 120 sites on~     the chest and back and using special computerized analysis of the recordings can help make~     catheter ablation for dangerous heart rhythms more effective.~   "
143956|NCT01170403|"~     64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the~     diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery~     disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures~     depending on different status of metabolic diseases. The investigators also aimed to analyze~     the risk factors associated with number and severity of stenosis as well as plaque~     characteristics using logistic regression models.~   "
143957|NCT01170390|"~     The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral~     contraceptive metabolism in a manner which results in decreased effectiveness in obese~     women.~   "
143958|NCT01170377|"~     The aim of this study is to evaluate the effect of valproate on the required dose of~     propofol for sedation in patients with mental retardation.~   "
143959|NCT01170364|"~     Obesity is a major public health concern, and the search for useful pharmacologic~     interventions is ongoing. This study aims to develop a comprehensive series of assessments~     to directly assess eating behavior, cognitive functioning, and psychological functioning~     under sibutramine and placebo conditions.~   "
143960|NCT01170351|"~     Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are~     corticosteroids (CS). In addition to being ineffective a substantial minority of cases,~     corticosteroid side-effects hamper effective therapy in another subgroup. Alternative~     options for induction of remission are limited. There are reports of successful salvage~     therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled~     studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no~     studies comparing CsA and CS in a head to head trial. The investigators aim to assess the~     efficacy and tolerability of CsA directly to the CS for induction of remission in~     treatment-naive AIH patients.~   "
143961|NCT01170338|"~     Assess the role of a nicotine antagonist in helping patients presenting to hospital with~     acute coronary syndrome to stop smoking.~   "
143971|NCT01170208|"~     The purpose of the study is to determine the effectiveness and safety of the computer~     software program in providing insulin dosage recommendations. Participation in the study for~     60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of~     weekly telephone calls from the study team (minimum of 12 calls). Participants will be~     provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin~     doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any~     changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or~     drop off a copy of the Study Log Sheet. This information will be entered by the IDC study~     team into the computer software program. The IDC study team will review the information from~     the software and, based on the IDC's study team approval, any insulin dose changes will be~     communicated back to the patient by phone or fax.~   "
143972|NCT01170195|"~     The purpose of the proposed study is to test the effect of Licorice Root Extract- Licogen on~     postmenopausal symptoms in postmenopausal women. Specifically, the study will also test the~     effect of the licorice extract on vaginal dryness.~   "
143962|NCT01170325|"~     Background:~        -  Electroencephalography (EEG) records electric patterns produced by the brain, and can~          detect conditions such as epilepsy or other l abnormalities that may affect brain~          function. In EEG studies, electric patterns that resemble epileptic seizures are known~          as epileptiform pattern. These patterns are associated with an increased risk of~          seizures, even in people who have not been diagnosed with epilepsy. Epileptiform~          patterns also appear on the EEGs of some children who have autism spectrum disorders~          but do not have epilepsy. It is unclear if these discharges are related in any way to~          the symptoms of autism (behavior, language or intellectual abilities).~        -  Divalproex sodium (Depakote) is a drug that has been used for many years to treat~          epilepsy and other brain disorders in children and adults. Researchers are interested~          determining whether treatment with divalproex sodium can reduce epileptiform patterns~          in children with autism spectrum disorders, and in doing so study whether this~          treatment can improve behavior, language or cognition in children with autism spectrum~          disorders.~      Objectives:~      - To study the effectiveness of using divalproex sodium to reduce epileptiform EEG~     discharges in children with autism spectrum disorders.~      Eligibility:~      - Children between 3 and 10 years of age who have an autism spectrum disorder and show~     frequent epileptiform discharges on an overnight EEG.~      Design:~        -  This study will last for a total of 9 months, with 6 months of treatment with either~          divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium~          only.~        -  Potential participants will be screened with a physical examination and medical~          history, blood samples, and psychological tests, and will spend the night in the NIH~          Clinical Center to have an overnight EEG. Children with frequent epileptiform~          abnormalities on the EEG will continue with the study; all others will be considered~          ineligible.~        -  Eligible participants will receive either divalproex sodium or a placebo to be taken~          twice daily for 24 weeks. Neither the investigators nor the participants will know~          which they are taking.~        -  Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects~          and to test for possible behavioral improvement, and will also have overnight EEG~          testing at 12 and 24 weeks.~        -  At the end of the 24-week study period, participants will have the option to have an~          additional 12 weeks of treatment with divalproex sodium.~        -  A final evaluation (including EEG) will be conducted at the end of the final treatment~          period.~   "
143963|NCT01170312|"~     Rotator cuff tears are a common injury that lead to pain and loss of function for those who~     suffer from it. Treatment includes the use of arthroscopic surgery to return function to the~     patient and reduce their pain. This study is interested in a technique that has the~     potential to improve patient outcomes in terms of less pain and better function after their~     surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the~     intervention of interest, which is simply the patient's own blood that is withdrawn and spun~     down to obtain a high concentration of cells called platelets. Platelets release growth~     factors important for healing, as well as fibrin, which acts like a biological glue. The PRP~     is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has~     been shown to accelerate healing in other studies for injuries such as chronic elbow~     tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP~     in rotator cuff tears. It is on this basis that the study is being performed. Participating~     patients will receive either a PRP injection or a placebo (normal saline) and the effects~     will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to~     function questionnaires. The primary hypothesis for this study is that ACP compared with~     placebo is effective in reducing pain at the site of a rotator cuff injury that has~     undergone arthroscopic repair. It is expected that ACP administered during surgery and 4~     weeks post-surgery will reduce 6-week pain scores compared to the placebo group.~   "
143964|NCT01170299|"~     RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet~     known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel~     side effects caused by radiation therapy.~      PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it~     works compared with a low-fiber diet in preventing bowel side effects in patients undergoing~     radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal~     cancer.~   "
143965|NCT01170286|"~     The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated~     epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device)~     in peanut allergic subjects.~   "
143966|NCT01170273|"~     Vitamin D insufficiency is a problem of growing concern, given its prevalence in older~     persons and the association of low vitamin D with multiple major health problems, including~     mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain~     cancers. Sedentary persons are particularly vulnerable for these health problems and~     generally not adherent to prescribed physical activity. This study will investigate if~     treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.~   "
143967|NCT01170260|"~     This research is studying behaviors that young people engage in that may place them at risk~     for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational~     program works best to reduce these risky behaviors.~   "
143968|NCT01170247|"~     The purpose of this study is to determine if intranasal ketamine is equally as effective and~     safe as intramuscular ketamine for procedural sedation in pediatric patients.~   "
143969|NCT01170234|"~     There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a~     chronic allergic diseases characterized by significant infiltration of eosinophils in the~     esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO)~     are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are~     also elevated in immunological diseases that do not involve the airways. The investigators~     hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled~     breath and that changes in FeNO levels could be used to measure disease activity. The~     objective of this study is to determine the feasibility of using FeNO as a noninvasive~     surrogate marker for EoE disease activity. The investigators propose to measure serial~     exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during~     and after the course of topical corticosteroid therapy to determine whether the level~     declines from pre-treatment level in individual patients.~   "
143970|NCT01170221|"~     This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701~     FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10~     days for the treatment of ABSSSI in adults.~      Approximately 75 to 100 sites globally will participate in this study. Patients with an~     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be~     randomized 1:1 to study treatment~   "
143973|NCT01170182|"~     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules~     under fed condition.~   "
143974|NCT01170169|"~     This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules~     under fasting condition.~   "
143992|NCT01169870|"~     The purpose of this study is to evaluate the overall response rate of Genexol-PM compared~     with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in~     anthracycline-pretreated patients with metastatic breast cancer.~   "
143993|NCT01169857|"~     The primary objective is to test the safety and efficacy of Velcade to induce remission in~     WHO class III/IV/V lupus nephritis that are refractory to standard medications.~   "
143975|NCT01170156|"~     The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs~     is usually considered as a major risk factor for bacterial tracheal colonization and~     subsequent development of ventilator-associated pneumonia. The rate of leakage around the~     cuff is related to the pressure differential across the cuff, namely the difference between~     the pressure of the subglottic fluid above the cuff and the tracheal pressure under the~     cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the~     cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during~     prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid~     leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning~     manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a~     high-volume low-pressure tracheal tube cuff when performed with a high level of suction~     pressure (- 400 mbar) and a large size of suction catheter size (16 French).~   "
143976|NCT01170143|"~     To compare the efficacy in terms of the pathological complete response rate (pCR) to~     preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH)~   "
143977|NCT01170130|"~     The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine~     1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving~     effective mydriasis during phacoemulsification surgery.~   "
143978|NCT01170117|"~     Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and~     mortality. Weight restoration is a treatment priority, and better treatments are needed.~   "
143979|NCT01170104|"~     To evaluate the time to progression of the combination therapy of Transcatheter Arterial~     Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or~     metastatic hepatocellular carcinoma.~   "
143980|NCT01170091|"~     Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome~     Patients: An Open-Label, Postmarketing Surveillance Study~   "
143981|NCT01170078|"~     This study assessed the comparability of the pharmacokinetics (PK) of epoetin following~     intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients~     with chronic renal failure receiving hemodialysis treatment.~   "
143982|NCT01170065|"~     The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with~     Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that~     drug.~      The primary objective will be to establish the long term tolerability and safety profile of~     BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).~      As a secondary objective the effects of long term treatment with BIBF 1120 on survival as~     well as safety and efficacy parameters will be investigated in an open-label, not~     randomized, un-controlled design.~   "
143983|NCT01170052|"~     The purpose of this study is to assess the safety, tolerability and activity of the~     combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell~     lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell~     transplantation.~   "
143984|NCT01170039|"~     The investigators will recruit a total of 136 diabetic men and women with constipation into~     this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The~     investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours~     after initiation of study drug (SBMs) in all patients two weeks before treatment with~     lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule.~     Colon transit reflects that rate of colonic peristalsis and movement of stool through the~     large bowel.~      Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks~     or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic~     transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week~     will be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will~     over-sample African American patients to achieve approximately 50% enrollment of this group.~     In a subanalysis, the investigators will assess response to treatment between the general~     population and African Americans.~      We hypothesize that lubiprostone will significantly increase the number of SBMs as well as~     decrease colonic transit time and improve quality of life in constipated diabetic patients~     compared with placebo.~   "
143985|NCT01169961|"~     The purpose of the present study is to evaluate in hemodialysis patients, who have elevated~     serum ferritin ( >2000ng/ml) and transferrin saturation (TSAT) >30%, iron deposition in the~     heart, pancreas, liver and spleen using the T2* MRI technique.~      In addition, we will also measure the free iron forms in the plasma and LPI, LCI in red~     blood cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and~     oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA).~   "
143986|NCT01169948|"~     Recent advances in technology have resulted in the development of scanners that can n image~     the heart arteries within 10 to 20 minutes but without the need for admission to hospital or~     insertion of catheters. This means that coronary heart disease may be more readily~     identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms~     suggesting coronary heart disease. Here, we propose to assess the latest and most powerful~     scanners to see if it can accurately diagnose the extent of coronary artery disease and~     facilitate the planning of heart surgery.~   "
143987|NCT01169935|"~     Treatment of a wide range of diseases using stem cells and other types of cell appears~     promising. Following administration of cells it is often not clear where exactly the cells~     have gone and how many of them have reached the target site. This has been one of the~     challenges of developing these treatment options further. We have developed a method of~     labelling human cells with a magnetic resonance imaging (MRI) contrast agent which~     contains tiny iron filings. Following intravenous administration it is possible to see where~     the iron-labelled cells have gone using MRI scanning. We would like to do is to demonstrate~     that these cells behave normally and migrate to a site of inflammation. We plan to induce an~     area of inflammation in the forearm of healthy volunteers using the Mantoux test (a test of~     immunity against tuberculosis) before giving the labelled cells intravenously. After the~     Mantoux test we will give these volunteers iron-labelled cells and do MRI scans of their~     forearm to determine whether these cells can be seen accumulating in the target site.~   "
144028|NCT01169389|"~     This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a~     hyaluronic acid supplement) administered immediately following the completion of knee~     arthroscopy.~   "
143994|NCT01169844|"~     This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in~     patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for~     patients in the core trial, to obtain safety and tolerability information. The study will~     address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks~     over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of~     AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue~     dosing for another 6 month period (Part 2).~   "
143995|NCT01169831|"~     Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which~     are important for maintaining cardiovascular health. The prevalence of cardiovascular~     disease in older adults is associated with reduced circulating EPC numbers. Studies have~     shown reduced EPC number and function in old vs. young individuals, and endurance exercise~     training increases EPC number and function in young adults. Oxidative stress adversely~     affects endothelial cells and preliminary evidence indicates that oxidative stress~     negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative~     stress and may enhance EPC function in older adults. The investigators hypothesize that~     older endurance-trained athletes and matched sedentary individuals will have markedly~     divergent EPC function and that altering the physical activity levels of both groups will~     move them to intermediate points between these two extremes. The investigators also propose~     that the investigators can mimic the effect of exercise training on EPC function in cell~     culture by altering intracellular levels of a key enzyme and a signaling molecule which the~     investigators have shown to regulate EPC function with respect to exercise training in young~     individuals.~   "
143996|NCT01169818|"~     Primary Objective:~      To compare patient-led titration (intervention group) versus physician-led titration (usual~     standard of care) in optimizing the clinical use of insulin glargine in an Asian population~     of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs~     (OADs).~      Secondary Objectives:~      To determine the difference in glycemic control, safety, quality of life and treatment~     satisfaction between patient-led titration and usual care.~   "
143997|NCT01169805|"~     The aim of this prospective randomized controlled study was to compare the prophylactic~     effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on~     PCA-related nausea and vomiting after urologic laparoscopic surgery.~   "
143998|NCT01169792|"~     The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of~     tamoxifen.~      The investigators want to~        -  evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450~          subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and~        -  analyze the association between the genetic polymorphisms of cytochrome P450~          subfamilies and clinical outcomes in breast cancer patients treated by adjuvant~          tamoxifen therapy.~   "
143999|NCT01169779|"~     The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in~     comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea,~     over a period of 24 weeks of treatment.~      The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010)~     in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in~     terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.~      The secondary objectives are to assess the effects of lixisenatide over 24 weeks on~     percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or~     equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG)~     and glucose excursion during standardized meal test, body weight; to evaluate safety,~     tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.~   "
144000|NCT01169753|"~     The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to~     control fatigue in patients with CML. The safety of this drug will also be studied.~   "
144001|NCT01169740|"~     Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous~     device (bilirubinometer) and laboratory analysis of blood samples.~      We hypothesise that correlation of the two measurements depend on bilirubin level,~     gestational age as well as postnatal age.~   "
144002|NCT01169727|"~     The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive~     Pulmonary Disease (COPD) patients in response to treatments in clinical practice.~   "
144003|NCT01169714|"~     This study is designed to observe the safety and blood concentrations of PF-04995274 during~     and following the administration of multiple doses of PF-04995274 for a duration of 14 days,~     in healthy adult and healthy elderly.~   "
144004|NCT01169701|"~     The objective of the study is to compare the cardiovascular profile of an everolimus and~     mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic~     acid regimen in maintenance renal transplant patients~   "
144005|NCT01169688|"~     This study was done to compare efficacy, safety and efficiencies of various methods of pupil~     dilation prior to cataract surgery.~   "
144006|NCT01169675|"~     This Phase I study will investigate the safety of BIBW 2992 in combination with standard~     dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers.~     BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on~     days 1 to 6 of a 21 day cycle.~      The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs),~     including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung~     cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as~     single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data~     obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely~     administered in advanced cancer patients in combination therapy with pemetrexed.~   "
144007|NCT01169662|"~     Nitrate provides the body with an alternative source of Nitric Oxide which plays a large~     role in promoting blood flow and reducing blood pressure. Nitrate supplementation with~     vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy~     expenditure during low intensity exercise. Such findings combined with the previously known~     biological effects of nitric oxide would suggest that nitrate supplementation would also~     impact on blood flow. The aim of this study is to examine the effects of dietary nitrate~     supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near~     Infrared Spectroscopy).~   "
144008|NCT01169649|"~     The purpose of this study is to test a new drug called MK-2206. This study is a phase II~     study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a~     new treatment has against a certain type of cancer.~      MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we~     hope that MK-2206 may stop the cancer cells from further growth and dividing. This study~     will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine~     tumor.~   "
144009|NCT01169636|"~     Objectives:~      Primary objective:~        -  Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) +~          Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination~        -  Randomized Phase-II: To estimate the complete response (CR) rate in patients with~          relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus~          PANOBINOSTAT plus ICE therapy~      Secondary Objectives:~        -  To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589)~          plus ICE versus ICE in patients with relapsed and refractory HL~        -  To estimate the overall response rate (CR + partial response PR)~        -  To estimate the success rate of stem cell collection in patients eligible for stem cell~          transplant~        -  To estimate the percentage of patients who subsequently undergo autologous stem cell~          transplantation (ASCT)~        -  To estimate the event free survival (EFS) at 1 year after randomization~        -  To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and~          pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by~          Immunohistochemistry (IHC) and correlate the results with treatment response~   "
144010|NCT01169623|"~     Hypothesis Applying Educational Intervention Based On Supportive behaviour Leadership Model~     has positive effect on Head Nurses' performance in TUMS Hospitals.~      Specific objectives~        1. Assessing the impact of supportive leadership behaviour on individual head nurse~        2. Assessing the impact of supportive leadership behaviour on nursing team~        3. Assessing the impact of supportive leadership behaviour on TUMS organizational success,~          especially in cross-functional environments~        4. Develop a specific plan for effectively supportive leadership behaviour the efforts of~          others to sustain and encourage productive performance and employee satisfaction~   "
144011|NCT01169610|"~     The overall hypothesis of this line of research is that varenicline will decrease alcohol~     consumption and tobacco use and will increase alcohol and tobacco abstinence rates. In order~     to explore this hypothesis, the investigators will conduct a two-phase study: 1) an open~     label pilot study investigating the effect of varenicline on reduction of and abstinence~     from alcohol and tobacco; and 2) an optional MR spectroscopy to investigate whether~     glutamate and other brain metabolites correlate to measures of alcohol craving severity~     and/or subsequent varenicline treatment response.~   "
144012|NCT01169597|"~     Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and~     involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the~     recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20~     mg as appropriate. However, probably because of the dramatic response of PMR to GC,~     randomized controlled trials of treatment are lacking. As a result, there is no evidence~     from controlled studies on the efficacy of different initial doses or drug tapering.~     Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in~     polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.~      Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day~     prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible~     predictors of response to prednisone. Remission is defined as disappearance of at least 75%~     of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a~     scenario allowing steroid tapering.~   "
144013|NCT01169584|"~     This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric~     patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy~     and/or the patient does not tolerate standard therapies. Tumors are likely to include~     neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma,~     non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors.~     Benign tumors are excluded. These tumor types were selected because evidence of biological~     activity was observed in cancer cells lines and ex vivo infected primary human tissue~     samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.~   "
144014|NCT01169571|"~     The objective of this study is to characterize the hemodynamic effects of Precedex~     (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated~     post-surgical subjects in an intensive care setting.~   "
144015|NCT01169558|"~     This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5~     mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based~     chemotherapy as first line treatment in participants with metastatic cancer of the colon or~     rectum. The anticipated time on study treatment is 3-12 months.~   "
144016|NCT01169545|"~     The primary purpose of this study is to examine how vulnerabilities in psychological and~     social situations affect financial quality of life.~   "
144017|NCT01169532|"~     This phase I trial is studying the side effects and best dose of giving ridaforolimus and~     vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving~     ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
144018|NCT01169519|"~     Patients with single ventricle anatomy undergo staged surgical palliation. The result is an~     in series circulation with pulmonary blood flow and cardiac output directly related to~     pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the~     single ventricle palliation results in continued long term attrition. Elevated pulmonary~     vascular resistance and impaired systemic ventricular function are important risk factors~     for failure of single ventricle palliation.~      Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in~     the pressure overloaded right ventricle.~      The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of~     sildenafil in single ventricle patients following stage II and III surgical palliation.~   "
144029|NCT01169376|"~     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may~     help doctors identify and learn more about biomarkers related to cancer.~      PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.~   "
144019|NCT01169506|"~     Sublingual positioning of a silicon capillary system is applied. After 15 min, while the~     individual is in resting position with closed mouth and normal tidal breathing through the~     nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension~     is measured.~      The investigators hypothesis is that this setup offers a non-invasive assessment of~     ventilatory efficiency with similar accuracy as arterial PCO2.~   "
144020|NCT01169493|"~     Heart failure (HF) affects 5 million Americans and is responsible for more health-care~     expenditure than any other medical diagnosis. Approximately half of all HF patients have~     electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a~     perturbation of the normal pattern of ventricular contraction that reduces the efficiency of~     ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF~     symptomatology in this subset of patients. Resynchronization of ventricular contraction is~     usually achieved through simultaneous pacing of the left and right ventricles using a~     biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial~     evidence supporting the use of BiV pacing in patients with prolonged QRS duration was~     obtained almost exclusively in patients with a left bundle-branch block (LBBB)~     electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular~     contraction in patients with LBBB can be obtained by univentricular left ventricular pacing~     with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that~     ventricular resynchronization can be obtained in subjects with right bundle-branch block~     (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to~     support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic~     HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac~     death. Most of these devices are currently programmed to avoid RV pacing. We aim to~     determine if ventricular resynchronization delivered through univentricular RV pacing~     improves symptoms in patients with RBBB and moderate to severe HF who have previously~     undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if~     ventricular resynchronization improves myocardial performance and ventricular geometry as~     detected by echocardiographic measures and quality of life for patients with HF and RBBB. We~     hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that~     maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac~     performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.~   "
144021|NCT01169480|"~     The aim of this study is to investigate if giving a massage impacts the mental state of a~     massage therapist, including depression, anxiety, and stress . It is speculated that~     feelings of depression, anxiety and stress will reduce following the giving of a massage.~   "
144022|NCT01169467|"~     The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in~     addition to the current standard-of-care for sedation.~   "
144023|NCT01169454|"~     The purpose of this study is to explore two currently accepted methods of intracranial~     pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients~     diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of~     two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH~     patients. The study will enroll only those patients who have ICP monitoring. Because this is~     an observational study, there are no physical risks to the patient, the only risk is loss of~     confidentiality.~   "
144024|NCT01169441|"~     The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has~     changed the population of patients being implanted. Younger and healthier patients are now~     being implanted for primary prevention of sudden cardiac death. Due to the younger~     population, the likelihood of the lead failing during the lifetime of the patient is higher~     and also more likely to need extraction. To reduce the risk of the lead extraction procedure~     and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads~     to offer improved chronic extractability to reduce the morbidity and mortality during these~     procedures.~   "
144025|NCT01169428|"~     The purpose of this study is to determine whether a 12 week Mindfulness-Based Weight Loss~     Maintenance (MBWLM) intervention is effective in maintaining recent loss of 10% or more of~     initial body weight.~   "
144026|NCT01169415|"~     Purpose and Objective:~        1. To compare the effects of either an abbreviated or protracted taper of dexamethasone on~          functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.~        2. To compare neurocognitive function in newly diagnosed GBM patients receiving either an~          abbreviated or protracted taper of dexamethasone.~        3. To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an~          abbreviated or protracted taper of dexamethasone.~        4. To examine the association between functional capacity and neurocognitive function and~          patient-reported measures (i.e. quality of life, fatigue, etc.) in newly diagnosed GBM~          patient on either an abbreviated or protracted taper of dexamethasone.~        5. To examine the association between functional capacity and neurocognitive function and~          body composition measures (body-mass index, etc.) in newly diagnosed GBM patient on~          either an abbreviated or protracted taper of dexamethasone.~        6. To examine the association between functional capacity and neurocognitive function and~          biochemical metabolic measurements in newly diagnosed GBM patient on either an~          abbreviated or protracted taper of dexamethasone.~      All study endpoints will be assessed at three timepoints as follows: (1) initial assessment~     after surgery in the hospital, (2) second assessment at initial clinical visit at the~     Preston Robert Tisch Brain Tumor Center (PRT-BTC) at Duke, approximately 1 week~     post-operatively, and (3) third assessment at second clinical visit in the PRT-BTC at Duke,~     approximately 10 weeks post-operatively and after completion of radiotherapy. An additional~     fourth assessment will be obtained at 4 weeks post-operatively if the subject is undergoing~     radiotherapy here at Duke.~   "
144027|NCT01169402|"~     Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support~     children who suffer heart or lung failure until whatever illness caused that failure can be~     treated and reversed. While on ECMO, children are at increased risk of infection, including~     fungal infection. Treatment for fungal infection includes not only antifungal medications~     but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines,~     proper treatment of fungal infections would be difficult if not impossible. The~     investigators believe that giving prophylactic antifungal medication to all children on ECMO~     may prevent fungal infections from developing in the first place.~      Fluconazole is an antifungal medication that works well against the most common fungal~     infections and has been shown to be safe in children. Unfortunately, the ECMO machine has~     the potential to significantly alter the drug levels of medications so the investigators do~     not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of~     fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on~     preliminary data and modeling from other studies, the investigators think 25mg per kilogram~     given once weekly will achieve proper drug levels to prevent fungal infections. The~     investigators have obtained FDA approval to give this dose of fluconazole to children on~     ECMO who are enrolled in the study. Blood samples will be collected at specific times around~     the first and second fluconazole doses to describe the PK and drug extraction by the ECMO~     circuit.~   "
144030|NCT01169363|"~     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the~     laboratory may help doctors predict how well patients will respond to treatment.~      PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from~     older patients with acute myeloid leukemia treated with cytarabine-based therapy.~   "
144031|NCT01169350|"~     This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans~     to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue~     sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic~     procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to~     find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors~     predict how well a patient will respond to treatment.~   "
144032|NCT01169337|"~     This randomized phase II/III trial studies how well lenalidomide works and compares it to~     observation in treating patients with asymptomatic high-risk asymptomatic (smoldering)~     multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system~     in different ways and stop cancer cells from growing. Sometimes the cancer may not need~     treatment until it progresses. In this case, observation may be sufficient. It is not yet~     known whether lenalidomide is effective in treating patients with high-risk smoldering~     multiple myeloma than observation alone.~   "
144033|NCT01169324|"~     The purpose of this prospective, participant-blinded trial is to determine the changes in~     sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS)~     surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease~     (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral~     subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months~     after the procedure. The cause of this improvement in sleep quality is unknown, and this~     study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is~     independent of improvement in night-time mobility associated with DBS treatment of the motor~     symptoms of PD, tremor, or dystonia.~   "
144034|NCT01169311|"~     Trial Objectives~      The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid~     and Prolapse Stapling Set:~      overall performance defined by the successful creation of a normal staple line safety as~     measured by the 30 day incidence of adverse events.~   "
144035|NCT01169298|"~     To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell~     leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received~     therapy for ATL and PTCL~   "
144036|NCT01169285|"~     The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer~     of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and~     the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting~     the use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's~     emotional well-being. A literature search provided extension of the tool to a Cardiac~     Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint~     Elizabeth.~      The emotional well being of patients and their significant others is a hallmark of wholistic~     care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or~     intervention at four. The validity testing of the tool was done against the Hospital Anxiety~     and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18).~      The purpose of this study is to measure the efficiency and efficacy of the documentation of~     the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The~     frequency of the documentation will be counted and type of documentation will be~     categorized.~   "
144037|NCT01169272|"~     Sorin Group has developed a new atrial lead which is under evaluation during this study. The~     SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature;~     interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.~      The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the~     physician in his diagnosis avoiding potential lost of capture.~      The ICD device has also the capability to be remotely interrogated through the remote~     monitoring system whose performances will be reported during the study.~      Finally, the study will report the electrical and handling performances of the new left~     ventricular lead.~   "
144038|NCT01169259|"~     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial in 25,874~     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3~     (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses.~   "
144039|NCT01169246|"~     Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple,~     dual or triple chamber ICD.~   "
144040|NCT01169233|"~     The success of human expedition missions critically depend on the ability of the crew to be~     alert and maintain high levels of cognitive function while operating complex, technical~     equipment. Optimal human health, performance and safety during space flight requires~     sufficient sleep and synchrony between the circadian pacemaker—which regulates the timing of~     sleep, endocrine function, alertness and performance—and the timing of the imposed~     sleep-wake schedule.~      Crewmembers of the 105-day simulation study will be required to work one night shift every~     sixth night. This schedule will likely result in sleep loss and circadian misalignment,~     especially when lighting conditions are similar to those that crewmembers experience during~     spaceflight. External mission controllers will work 24-hour shifts, also resulting in both~     sleep loss and circadian misalignment.~      It has been well documented in laboratory and field studies that both working the night~     shift and working extended duration shifts result in decrement alertness, performance and~     mood. In addition to the negative effects that night shift work has on alertness,~     performance and mood, shift work causes significant short and long-term health problems.~     Shift workers, particularly night shift workers who invert their normal sleep/wake schedule,~     suffer for several reasons. First, their endogenous circadian rhythms and the imposed~     sleep/work schedule are typically out of phase. This is similar to the experience of jet~     lag. However, while environment cues (e.g., sunrise, sunset, the timing of meals and sleep)~     enable travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation~     will be unable to do so because they will only spend one night of every five working. When~     working the night shift, the timing of meals, work, and sleep will therefore be out of phase~     with the normal entrained phase of the circadian timing system. Ingestion of meals at an~     inappropriate circadian phase results in impaired metabolism, likely underlying the~     gastrointestinal and metabolic problems experienced by shift workers. Second, this circadian~     misalignment leads to a substantial loss of sleep efficiency during the (daytime) sleep~     period, independent of, and in addition to, environmental obstacles to sleep (e.g., noise,~     light, other crewmembers). Third, misalignment of circadian phase coupled with sleep loss~     will each result in deterioration of alertness and impairment of performance during the~     night. Since these adverse effects are particularly acute on the first night of work, the~     plan for crewmembers on the Mars 105 mission to work the midnight shift every sixth night~     will subject them repeatedly to the performance impairments associated with acute circadian~     misalignment and acute sleep deprivation.~      Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed~     and tested effective photic countermeasures to alleviate circadian misalignment and improve~     alertness, performance and mood in night shift workers. The most effective countermeasure to~     circadian alignment is appropriately-timed and sufficiently intense light. Light also~     acutely improves alertness, performance and mood. Most recently it has been reported that~     short wavelength light has been shown to be most effective for both resetting circadian~     rhythms and acutely improving performance during night work via antecedent suppression of~     the soporific hormone melatonin.~      These photic countermeasures have been tested in individual subjects living in laboratory~     simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with~     human subjects in controlled laboratory simulating operational spaceflight environment). The~     next critical step is to evaluate our countermeasures in an operational simulation of space~     flight that includes study of the interaction among crew members in a high fidelity~     simulation (Countermeasures readiness level/Technology readiness level 8; Validation with~     human subjects in actual operational spaceflight to demonstrate efficacy and operational~     feasibility).~      Adequate sleep and circadian alignment are critical to maintaining the health and~     performance of expedition mission crewmembers. Testing of the developed lighting~     countermeasure in a high fidelity operational environment imitating the conditions of a~     future expedition mission (e.g., to Mars) is critical to ensure countermeasure readiness and~     to reduce the risk of human performance errors due to factors related to circadian~     disruption, sleep loss and fatigue. Development and testing of this photic countermeasure~     for mission controllers working 24-hour shifts will further ensure the success of the future~     long duration expedition missions.~   "
144041|NCT01169220|"~     This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy:~     the entire preparation taken the night before the procedure versus half the preparation~     taken the night before the procedure, and the other half taken the morning of the procedure.~   "
144042|NCT01169207|"~     This research is being done to find out why Inflammatory Bowel Disease (IBD) (i.e., Crohn's~     disease and ulcerative colitis) occurs in individuals and in families. Recently the~     investigators and other researchers have found a gene (DNA) that when changed, gives people~     a higher risk for developing IBD or other inflammatory diseases like IBD. By doing this~     research, scientists and doctors will study the cells in the blood to see how the~     gene-change affects the way the blood cells' immune system works.~   "
144043|NCT01169194|"~     The investigators are doing the research to discover genes that cause Inflammatory Bowel~     Disease (IBD) specifically in the African American population. Who May Join This Study?~     Blacks / African Americans with or without Crohn's disease or ulcerative colitis.~      If you agree to join the study, the investigators ask that you give us information about~     your health. The investigators will also ask you to give us a blood sample so that they may~     discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any~     local facility convenient to you.~   "
144057|NCT01169012|"~     This is a non-blinded, non-randomized pharmacokinetic study to determine the oral~     bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics~     in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).~   "
144044|NCT01169181|"~     The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical~     vibration applied to the surface of the forearm, and (3) stimulation of the brain with~     either transcranial magnetic stimulation (TMS) or transcortical direct current stimulation~     (DCS). These 3 components of the procedure are carried out simultaneously. Each subject will~     be evaluated pre- and post-treatment with several clinical tests of functional movement. The~     hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will~     enable most of the stroke patients to recover finger extension.~   "
144045|NCT01169168|"~     In this study patients with~        1. chronicle liver diseases~             -  primary biliary cirrhosis~             -  primary sclerosing cholangitis~             -  alcoholic liver cirrhosis~             -  hepatitis b or C~             -  Wilson's disease~             -  cryptogenic cirrhosis~        2. Septic Inflammatory Response Syndrome (SIRS)~             -  sepsis~             -  septic shock~        3. patients after lysis~      should be included~      Blood samples will be gathered from the patients to measure fibrinogen with 5 different~     methods.~      The methods are:~        -  Clauss fibrinogen~        -  PT-Derived fibrinogen~        -  immunoturbidimetric method~        -  heat-precipitated fibrinogen~        -  Schulz fibrinogen~      The result of these tests will be correlated with laboratory values which are gathered in~     routine and the clinical outcomes.~   "
144046|NCT01169155|"~     Specific Aim 1 is to test the hypothesis that there are specific characteristics of a voice~     smoke alarm (i.e., use of child's first name, behavior commands in the message content, use~     of mother's voice, and stimulus frequency) that will awaken children 5-12 years old in stage~     4 sleep. The successful children's alarm will be tested among adult subjects to evaluate~     effectiveness across the age spectrum.~      Specific Aim 2 is to test the hypothesis that there are specific characteristics of a voice~     smoke alarm (i.e., use of mother's voice and behavior commands in the message content) that~     will result in successful completion of simulated escape behaviors by children 5-12 years~     old after awakening from stage 4 sleep. The successful children's alarm will be tested among~     adult subjects to evaluate effectiveness across the age spectrum.~   "
144047|NCT01169142|"~     Supplementation of Vitamin D in those with low levels will increase the level and result in~     some improvement in health and psychopathology measures.~   "
144048|NCT01169129|"~     Patients in good general condition with resectable brain metastases, looks better with more~     intense treatment of metastases. This local treatment has been accomplished with surgery or~     radiosurgery. However, there are no randomized studies comparing these two types of~     treatment. The purpose of this study is to make this.~   "
144049|NCT01169116|"~     Patients with single brain metastasis without other metastatic site have a better prognosis,~     and they need a better brain metastasis control. For non-resectable and non-radiosurgical~     brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10~     fractions, but the local control is not achieved in most of the cases. This study~     investigate the possibility to increase radiation dose in this metastasis with exclusive~     hypofractionated stereotactic radiotherapy.~   "
144050|NCT01169103|"~     Teenagers and adults who are overweight or obese have an increase in fat in the abdomen,~     which increases their risk for diabetes and heart disease. Reducing abdominal fat is~     important to reduce risk for diabetes and for heart disease. Overweight teenagers also have~     low levels of growth hormone compared to normal weight teenagers, and teenagers with the~     lowest growth hormone levels also have the greatest abdominal fat. In children who are~     unable to make growth hormone for other reasons, giving back growth hormone leads to a~     decrease in abdominal fat. We are studying whether giving growth hormone in small doses to~     overweight teenagers can change body composition. We hypothesize that growth hormone will~     cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.~   "
144051|NCT01169090|"~     The purpose of this study is to evaluate the safety and efficacy of a range of doses of~     SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin~     alone.~   "
144052|NCT01169077|"~     Malaria, a disease responsible for over one million deaths per year, is caused by a germ~     spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for~     the prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the~     device used to give the vaccine. This study will provide information on how safe, effective,~     and tolerable the vaccine is in healthy adults. The participants will be assigned, by~     chance, to receive 3 doses/shots of the vaccine or a placebo (substance that contains no~     medication) by injection in the upper arm. Study participants will include 39 healthy adults~     aged 18-40 years who have not been exposed to malaria and who will enroll at the Emory~     Vaccine and Treatment Evaluation Unit in Atlanta, Georgia. Study procedures include physical~     exams and several blood samples. Participants will be involved in the study for~     approximately seven and one half months.~   "
144053|NCT01169064|"~     A common concern in any surgical procedure is the occurrence of infection. Silver-containing~     treatments are popular and used in wound treatment; however, there is presently little~     evidence of the effectiveness of silver-containing treatment for the prevention of~     obstetrical wound infection. We plan to investigate the rate of infection in women~     experiencing cesarean sections at VUMC by comparing the infection rate based on a randomized~     choice of silver-containing wound dressings to soft cloth adhesive wound dressings.~   "
144054|NCT01169051|"~     There is data to support an association between impaired preoperative endothelial function~     and adverse postoperative outcome. This study will investigate the potential association~     between perioperative statin use and improved perioperative and long-term cancer outcome~     amongst thoracic surgery patients undergoing lung or esophageal resection.~   "
144055|NCT01169038|"~     Sarcoidosis is a granulomatous disease for which the molecular and immunologic association~     with mycobacteria continues to strengthen. The investigators are interested in conducting a~     proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The~     investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are~     given antimycobacterial therapy, in addition to their standard therapy.~   "
144056|NCT01169025|"~     Often, patients transported by aeromedical systems do not receive enough medication to~     control and relieve their pain. The purpose of this study is to determine if pain treatment~     with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the~     current treatment practices.~   "
144058|NCT01168999|"~     The purpose of this study is to determine whether a novel placebo for comparison to spinal~     manipulation is believable and creates similar expectation for treatment effectiveness as~     the studied spinal manipulation technique. Additionally, we wish to compare outcomes related~     to low back pain, function, and pain sensitivity between people receiving the placebo,~     spinal manipulation, and no therapy.~   "
144059|NCT01168986|"~     This study is comparing the effectiveness of a mechanical manual therapy device to a~     specific exercise to no treatment in individuals experiencing neck pain. We are interested~     in the effects of the interventions on neck pain, disability related to neck pain, and pain~     sensitivity.~   "
144060|NCT01168973|"~     The purpose of the study is to compare the survival of participants who receive chemotherapy~     and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior~     first line platinum-based chemotherapy.~   "
144061|NCT01168960|"~     Cognitive-behavioral therapy (CBT) is an effective treatment for alcohol dependence, but~     little is known about how CBT works to achieve these effects. Although several possible~     mechanisms have been proposed to explain the effects of CBT, it is rare that more than one~     mechanism is studied. However, it may be the case that similar outcomes (e.g., abstinence)~     may be reached through multiple paths. Therefore, essential to conducting work on behavioral~     change mechanisms is distinguishing different courses or paths and moderating influences~     (Kazdin, 2007). In the present study, we will focus on 2 key mechanisms posited to underlie~     the effectiveness of CBT specifically, increasing self-efficacy and self-confidence and~     reducing positive outcome expectancies for alcohol use, and 2 key mechanisms posited to~     underlie the effectiveness of a wide range of therapeutic interventions, increasing the~     therapeutic alliance and reducing/regulating negative emotional states. For the present~     study, participants will be 72 alcohol dependent men and women who agree to participate in a~     12-week trial of CBT for alcohol dependence. In addition, comprehensive research assessments~     will be conducted with patients at baseline, end of treatment, and 3-months posttreatment.~      Specific Aim 1. To examine the within-treatment week-to-week relationship between ratings of~     4 key therapeutic mechanisms and alcohol involvement (operationalized as percent days~     abstinent {PDA} and drinks per drinking day {DDD}) during treatment. It is hypothesized that~     self-efficacy, outcome expectancies, therapeutic alliance (as rated by the patient and~     therapist), and negative affect assessed after any given treatment session will each predict~     alcohol involvement during the following week. Exploratory analyses also will investigate~     the relationship of a given week's alcohol involvement on each of the four key variables as~     assessed the following week.~      Specific Aim 2. To examine profiles of the four key mechanisms over the course of treatment~     in relation to alcohol involvement during treatment and during the 3-month follow-up period.~     These analyses will be descriptive/exploratory. It is expected that profiles will emerge~     with the key mechanisms that are associated with decreased alcohol involvement (for example,~     when the alliance is relatively strong throughout treatment or when the alliance grows~     stronger over the course of treatment, or when positive outcome expectancies grow weaker~     over the course of treatment, etc.). Similarly, it is hypothesized that profiles will emerge~     that are associated with little improvement in alcohol involvement (for example, when~     negative affect is relatively high throughout treatment or when self-efficacy weakens over~     the course of treatment).~   "
144062|NCT01168947|"~     Sodium loading during hemodialysis treatment is common and may contribute to increased~     interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing~     0.9% sodium chloride) is one of the factors that may cause sodium loading. During each~     hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams~     of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered~     to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow~     for removal of the equivalent amount of sodium.~      Switching to a non sodium-containing solution for the priming and rinsing of the~     extracorporeal circuit can contribute to increased sodium removal during the dialysis~     treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved~     blood pressure control.~   "
144063|NCT01168934|"~     This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over~     single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV~     formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain~     at least 12 evaluable subjects who complete the study. Each subject will receive two~     treatments (A and B) with a washout period of at least 14 days between each treatment.~   "
144064|NCT01168921|"~     The goal of this clinical research study is to learn if eltrombopag can help to increase the~     number of platelets in patients with CLL. The safety of this drug will also be studied.~   "
144065|NCT01168908|"~     This study, supported by Charley's Fund, Inc., is being done to determine if the drug~     Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks~     like the study drug, but contains no medication), improves heart function in people with~     Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD).~      In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is~     associated with abnormalities in an enzyme called neuronal nitric oxide synthase or nNOS,~     and leads to decreases in cyclic GMP, which is necessary for proper function of those~     muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore~     the normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is~     safe for people with DBMD and if it can improve heart function.~      Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in~     patients with DBMD.~   "
144066|NCT01168895|"~     The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin~     after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75~     mg dose will be administered for the first time using a new high dose strength (i.e. one~     capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations~     will focus on local tolerability in the lung and evaluate whether the patient can inhale the~     higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how~     the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this~     study will be used to decide whether the new dose strength is suitable for larger clinical~     trials planned for the COPD patients population.~   "
144067|NCT01168882|"~     The purpose of the study is to determine the safety and tolerability of RGB-286638, a novel,~     multi-targeted kinase inhibitor, administered to patients with selected, relapsed or~     refractory hematological malignancies.~   "
144068|NCT01168869|"~     Some myocardial infarctions (MI) occur as the first manifestation of coronary artery~     disease. These are termed 'unheralded' events as they have not been preceded by other forms~     of coronary artery disease. Unheralded MIs are important because of the high likelihood of~     missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown.~      This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an~     estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those~     with angina of recent onset (MIs with premonitory symptoms).~   "
144069|NCT01168856|"~     This observational long-term follow-up study will assess the persistence of direct acting~     antiviral (DAA) resistant mutations and the durability of sustained virological response in~     patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol.~     Up to 5 scheduled monitoring visits for blood sampling during an observational period of up~     to 36 months.~   "
144070|NCT01168843|"~     Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal~     Brain Hemispheres Using 3-dimensional Ultrasound Planes~      This retrospective study is based on the computerized analysis of the orthogonal fetal brain~     planes.~      The images are obtained from the digital archive of the fetal sonographic examinations done~     in Bnai Zion Medical Center.~      In addition, midsagittal measurements of fetal head will be obtained from this archive of~     3-dimensional images.~      Study measurements will provide the quantitative parameters of normal fetal brain sulcation.~     Normal fetal head growth in midsagittal plane will be studied also.~   "
144071|NCT01168830|"~     First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety~   "
144072|NCT01168817|"~     This study examines the efficacy and safety of the combination treatment BAY60-4552 plus~     vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy~     with PDE5 (Phosphodiesterase 5) inhibitors.~      Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks~     of the study to assess the effect of PDE5 inhibitor therapy given alone.~      Patients with an insufficient therapeutic response to vardenafil alone will enter the next~     part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3~     chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone,~     or placebo. Neither patient nor the treating physician will know which treatment is given~     (double-blinded design).This part of the study will last four weeks Patients will have to go~     to the clinic/hospital for 7 visits during the 8 weeks.~   "
144073|NCT01168804|"~     The purpose of this study is to evaluate efficacy and safety of the combination regimen of~     bortezomib-bendamustine-dexamethasone in patients with relapsed or refractory multiple~     myeloma~   "
144074|NCT01168791|"~     This is an international, randomized, double-blind, placebo-controlled trial to evaluate the~     clinical efficacy of palifosfamide-tris administered with doxorubicin in combination,~     compared with doxorubicin administered with placebo in front-line patients diagnosed with~     metastatic soft tissue sarcoma (STS).~   "
144075|NCT01168778|"~     The excessive use of outpatient antibiotics in the pediatric population has contributed to~     the rapid development of resistance in many strains of Streptococcus pneumoniae. Research~     has shown that community-based interventions may have a modest impact on reducing the~     injudicious use of antibiotics in children. However, since the actual prescribing of~     antibiotics is done by physicians and research has shown that physician-parent communication~     patterns during pediatric visits for acute respiratory tract infections (ARTI) strongly~     influence antibiotic prescription rate, it is crucial to develop effective interventions~     aimed specifically at them.~      The overall goal of this study is to improve physician-parent communication patterns during~     visits for pediatric ARTI and, ultimately, to decrease rates of antibiotic prescribing for~     these illnesses in children.~   "
144076|NCT01168765|"~     Building from existing intervention strategies designed for the Mexican American population~     entitled Tu Salud Si Cuenta(TSSC) or Your Health Matters. This intervention highlights in~     the media successful role models who have changed their food choices and physical activity~     levels. In addition, the intervention designs environmental changes to help community~     members carry out recommended behavior change strategies. The purpose of this study is to~     test the efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign,~     a physical activity and healthful food choice intervention among Mexican Americans in the~     Lower Rio Grande Valley to achieve behavioral and clinical outcomes.~   "
144077|NCT01168752|"~     The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when~     administered orally, every-other-day or daily during the first 30 days, in patients with~     solid tumours or lymphoma.~   "
144078|NCT01168739|"~     The purpose of this study is to determine whether dietary quercetin supplementation effects~     thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.~      Specific Aim I. To determine if quercetin in combination with repeated bouts of thermally~     stressful exercise will impact intestinal barrier function. The investigators will examine~     urinary lactulose excretion, plasma endotoxin,plasma quercetin, inflammatory cytokines~     (TNF-a & Il-6), anti-inflammatory cytokines (Il-10), and HSP70 and HSF-1 content of~     peripheral blood mononuclear cells.~      Specific Aim II. To determine whether quercetin's suppresses the ability of human subjects~     to acclimate to exercise/heat stress. The investigators will examine body temperatures,~     heart rates, physiological strain, sweat and plasma volume responses to standardized heat~     tolerance tests.~   "
144079|NCT01168726|"~     Excessive college student drinking represents an important public health problem for both~     the students themselves and those with whom they interact. The objective of this research is~     to better understand how to reduce such high-risk drinking by improving prevention and~     treatment programs, which will provide an overall public health benefit. Subjects in the~     study will be randomized to one of two brief intervention conditions or an education-only~     control condition. It is hypothesized that those in the intervention conditions will report~     greater reductions in alcohol use and alcohol-related problems than those in the control~     condition.~   "
144080|NCT01168713|"~     Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in~     the treatment of adults with moderate to moderately severe community-acquired bacterial~     pneumonia.~   "
144089|NCT01168596|"~     The purpose of the research study is to determine if rasagiline is an effective treatment~     for fatigue in patients with Parkinson's disease (PD).~   "
144090|NCT01168583|"~     This study is about investigating the relationship of postoperative fluid balance,~     inflammation and acute kidney injury. This is a non-interventional study (no drug~     administration). The investigators will collect baseline demographic data, postoperative~     fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample~     (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.~   "
144091|NCT01168570|"~     Purpose of this study is to determine whether keeping SAA on normal or near normal level~     will delay progression of renal failure in patients with amyloidosis secondary to FMF.~   "
144227|NCT01166802|"~     The aim of this study is to develop and validate a questionnaire (non-invasive technique) to~     identify patients who are hypervigilant for noxious visceral sensations and who show a lower~     threshold to report pain. This questionnaire would be useful in studies investigating the~     role of visceral pain hypervigilance and pain sensitivity in the comorbidity of IBS with~     other somatic disorders.~   "
144081|NCT01168700|"~     Many studies have addressed the relationship between metabolic syndrome and cardiovascular~     disease. Risk factors include abdominal obesity, insulin resistance, abnormal lipid profile~     and hypertension. It is proposed that this condition leads to an increase in the production~     of inflammatory substances and endothelial dysfunction.~      New therapies have been studied to improve control of metabolic disorders and reduce the~     endothelium damage. Aged garlic extract (Kyolic®) is a promising intervention that has~     antithrombotic and antioxidant properties. At the moment there is not data about the effects~     of supplementation with AGE in the endothelial function of patients with metabolic syndrome.~     Thus, the purpose of this study is to investigate if the supplementation with Kyolic® can~     alter the plasma levels of inflammatory markers, insulin and the endothelial function of~     patients with metabolic syndrome.~      Methods and design: A randomized, cross over, double-blind, placebo-controlled trial will be~     performed to assess the effects of 1.2 g of Kyolic in insulin resistance and endothelial~     function of 46 patients with diagnosis of metabolic syndrome. The participants will be~     recruited from the primary care centers from E.S.E ISABU Bucaramanga. All subjects who meet~     the inclusion criteria will be randomly assigned to two periods of 12 weeks (Kyolic and~     placebo). Control visits will be programmed monthly to verify compliance and the presence of~     adverse events. Outcome variables (endothelial function assessed by flow mediated~     vasodilation, inflammatory markers, insulin plasma levels) will be evaluated at the initial~     visit and after 12 and 24 weeks of treatment.~   "
144082|NCT01168687|"~     The overall goals of this study are to (1) expand knowledge about interactions of~     levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in~     moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to~     measure postural control (which has been used as a marker of intoxication) and the effects~     of levetiracetam on postural control.~   "
144083|NCT01168674|"~     The primary outcome of this study is to determine if predictors of response can select a~     population of patients with MDD that is effectively treatable by augmentation with~     ziprasidone.~      Major depressive disorder (MDD) is a broad category, including many forms of depressive~     illness, including those with only a single major depressive episode, those with episodic~     recurrence with intervening well states, those with chronic depressive/anxious states~     without intervening euthymia, and those with manic symptoms that do not meet threshold~     definitions of full mania/hypomania.~      In this heterogenous, large diagnostic definition, important groups of patients do not~     appear to respond well to antidepressants, and, conversely, based on observational studies,~     may respond well to neuroleptics. These predictors of response have begun to be identified~     and may serve to better design studies of neuroleptics in depressive illnesses.~      Among these predictors of response in MDD are clinical features that are more similar to~     bipolar illness than unipolar depression. These include a family history of bipolar~     disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical~     depression, early age of onset of depression (< age 20), failure to respond to~     antidepressants, and antidepressant tolerance (initial response followed by later loss of~     response).~      The investigators propose to use these predictors to pick out patients that are more likely~     to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive~     response applied to neuroleptics.~   "
144084|NCT01168661|"~     The purpose of this study is to investigate if treatment with yoga or mindfulness has a more~     profound and longstanding effect on stress and burnout than treatment with cognitive~     psychotherapy alone.~   "
144085|NCT01168648|"~     The purpose of this study is to investigate if yoga can be an effective stress management~     technique for health care personnel.~   "
144086|NCT01168635|"~     Spirometry is a recommended component of asthma diagnosis and treatment in the primary care~     setting, yet few providers report its routine use for children with asthma.~     Misclassification of asthma severity occurs when assessment is based on symptoms alone. This~     misclassification can lead to inadequate treatment, increased morbidity, and increased~     healthcare utilization/cost.~      The goal of this study is to test the effectiveness of a distance learning quality~     improvement program called Spirometry 360 developed by the interactive Medical Training~     Resources (iMTR) group at the University of Washington Child Health Institute. The~     Spirometry 360 program aims to improve care for children with asthma by enhancing provider~     knowledge and self-efficacy related to the use and interpretation of office-based~     spirometry.~   "
144087|NCT01168622|"~     The effects of race/ethnicity on platelet function and response to antiplatelet agents will~     be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with~     aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor~     antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only~     aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at~     least 5 racial/ethnic groups.~   "
144088|NCT01168609|"~     Left atrial volume (LAV) provides the significant prognostic information in the general~     population and patients with heart disease, including acute myocardial infarction, left~     ventricular dysfunction, mitral regurgitation, cardiomyopathy and atrial fibrillation. Large~     left atrial volume, which represents chronic diastolic dysfunction, is associated with poor~     outcome, regardless of systolic function. Thereby, LAV provides a long-term view of whether~     or not the patient has the disease of diastolic dysfunction, regardless of whatever loading~     conditions are present at the time of the examination, as the hemoglobin A1C in diabetes.~     However, whether left atrial (LA) parameters could correlate with LVFP and reflect~     short-term change in left ventricular filling pressure(LVFP) remains unknown. Only one~     article of our team confirmed the relationship between LAV and LVFP in patients with severe~     mitral regurgitation by simultaneous echocardiography-catheterization. The prior report~     proposed a new parameter, LA distensibility, and disclosed its logarithmic relationship with~     LVFP. The LA distensibility precisely indicated rapid change in LVFP of patients with acute~     severe mitral regurgitation, and was even superior to mitral E/Em (early-diastolic mitral~     inflow velocity divided by early-diastolic mitral annular velocity). As left atrial pressure~     rises to maintain adequate left ventricular diastolic filling, increased atrial wall tension~     tends to dilate the chamber and stretch the atrial myocardium. Therefore, the smaller left~     atrial stretchability, the more pressure left atrium (LA) faces to. The first objective of~     this study was to test the value of LA distensibility for assessing LVFP, particularly in~     patients with acute myocardial infarction. The second objective was to assess the prognostic~     value of LA distensibility.~   "
144092|NCT01168557|"~     Electric Impedance Tomography (EIT) is a technique based on the injection of small currents~     and voltage measurements using electrodes on the skin surface generating cross-sectional~     images representing impedance change in a slice of the thorax.It is a radiation free, non-~     invasive and portable lung imaging technique. Impedance changes in lung ventilation as well~     as in lung perfusion can be shown. To investigate lung perfusion by EIT measurements,~     cardiac output measured by routinely undergone stress echocardiography at rest and stress~     are compared to parameters measured by EIT.~   "
144093|NCT01168544|"~     Vitamin D deficiency is common in older persons, in particular in residents of nursing~     homes. This is mainly explained by the fact that older persons do not often go outside in~     the sunshine. On top of that the capacity of the skin to synthesize provitamin D is~     decreased and dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis,~     falls and fractures. To prevent morbidity and mortality due to falls and fractures it seems~     logical to supplement vit D in order to correct the deficiency. The advised daily dose of~     vit D supplementation is 800 IU. Several studies showed that with this dose the required~     serum 25(OH)D levels will not be reached.~      primary objective of this study is:~        -  to investigate whether with a loading dose based on body weight and baseline serum~          25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a~          day.~        -  to determine the best consolidation treatment.~      Secondary objective~        -  is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in~          residents of nursing homes.~        -  is there a relation between the increase in serum 25(OH)D level and muscle strength~          (handgrip strength).~        -  is there a relation between the increase in serum 25(OH)D level and mobility (2 minute~          walk test).~      Study design:~      Randomised trial with 3 study groups:~        -  Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000~          IU vit D3/month consolidation therapy.~        -  Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000~          IU vit D3/month consolidation therapy.~        -  Group 2. 800 IU vit D3/ dag.~      Study population:~      Vitamine D deficient residents of nursing homes, 65 years or older.~   "
144094|NCT01168531|"~     Multimodal analgesia may be important for optimal postoperative pain treatment and~     facilitation of early mobilization and recovery. This study investigated the analgesic~     effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.~   "
144095|NCT01168518|"~     This observational study is a non-interventional multi-centre, prospective study.~      The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing~     leads. We plan to assess the acute and short term lead dislodgment rate (within the first~     three months following implantation) correlated with the type of lead (active- or passive-~     fixation). Further, we are collecting data related to leads handling and leads electrical~     performances~   "
144096|NCT01168505|"~     Study to evaluate the efficacy of intravenous iron supplementation in the prevention of~     anemia in patients receiving (neo)adjuvant breast cancer regimens.~   "
144097|NCT01168492|"~     The purpose of this study is to determine whether ketamine, midazolam, and meperidine are~     more effective than midazolam and meperidine alone for procedural sedation and analgesia in~     pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory~     side effects and the necessity of rescue doses.~   "
144098|NCT01168479|"~     Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in~     local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy~     fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35%~     in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility~     study up to appr. 85 Gy on the entire prostate has already been performed and showed~     acceptable toxicity when combined with adequate position verification. Higher doses to the~     entire prostate are expected to increase severe toxicity. As local recurrences only occur at~     the site of the primary macroscopic tumour area the next step in increasing the dose should~     be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest~     of the prostate to the current gold standard dose. Feasibility of this approach has been~     shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.~   "
144099|NCT01168466|"~     This study measures whether the symptoms of frontotemporal dementia (FTD) can be~     successfully treated by (a) biofeedback training to increase brain blood flow, (b)~     biofeedback to increase the frequency of the brain's dominant brainwave rhythm, and (c)~     rhythmic stimulation to increase the brain's dominant brainwave frequency.~   "
144100|NCT01168453|"~     This study was performed to ultrasonographically demonstrate the changes in relationship~     between the right internal jugular vein (IJV) and an anatomical landmark in two different~     head positions: neutral and rotational.~   "
144101|NCT01168440|"~     VHL patients may benefit from sunitinib. This study will investigate the following~     objectives :~      PRIMARY OBJECTIVE~        -  To determine the objective response rate according to RECIST criteria, in VHL patients~          with advanced tumors or tumors untreatable by other means, and treated with sunitinib.~      SECONDARY OBJECTIVES~        -  To evaluate the safety and tolerability of sunitinib in VHL patients according to the~          NCI-CTC criteria Version 3.0.~        -  To determine the following time-to-event endpoints: overall survival, time to disease~          progression, progression free survival, time to response and duration of response.~        -  To evaluate quality of life in VHL patients receiving sunitinib.~   "
144102|NCT01168427|"~     The purpose of this study is to gather evidence about the safety and feasibility of~     performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an~     office or clinic setting rather than the traditional hospital operating room, cardiac~     catheterization or electrophysiology (EP) laboratory setting.~   "
144103|NCT01168414|"~     This is a single-center, cross-over comparison parallel group randomized trial designed to~     evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8~     weeks each.~   "
144139|NCT01167946|"~     Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata~     but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate~     dosing, inadequate frequency or other factors is a matter of debate. The investigators~     decided to conduct this study using the oral pulse steroid, however with higher doses and~     more frequent pulses to patients with severe forms of Alopecia areata.~   "
144104|NCT01168401|"~     Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four~     dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with~     monophosphoryl lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects~     will receive two doses, by intramuscular (IM) injection, 28 days apart.~      The hypotheses for this study are:~        -  The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP~          Vaccine will be similar to the incidence of adverse events after other IM vaccines~          including CERVARIX® which contains MPL and AlOH.~        -  Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.~        -  The post-vaccination serum antibody responses, the number of antibody secreting cells~          (ASC), including homing markers, and memory B-cell responses directed against norovirus~          antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to~          controls.~   "
144105|NCT01168388|"~     Movement disorder involve recurring or constant muscle contractions causing squeezing or~     twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most~     common focal dystonia was cervical dystonia in western countries according to previous~     studies, which is different from China in Chinese neurologists' opinion. And there is no~     such survey. So the investigators are conducting a movement disorder survey in east China to~     confirm it.~   "
144106|NCT01168375|"~     80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection,~     Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups~     (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal~     epithelial defect following diabetic vitrectomy. Both groups will take the conventional~     medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case~     group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal~     epithelial defect will be measured by slit lamp.~   "
144107|NCT01168362|"~     Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of~     coronary heart disease. The investigators aimed to characterize coronary artery disease in~     subjects with cardiovascular risk or not, and in particular plaque natures depending on~     different status of cardiovascular risk. Especially,the investigators will evaluate the~     relationships between the pericardial fat and severity of stenosis as well as plaque~     characteristics using logistic regression models.~   "
144108|NCT01168349|"~     This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in~     daily routine practice in cancer patients with anemia. Data will be collected from patients~     who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will~     be followed for 28 weeks.~   "
144109|NCT01168336|"~     The study aims to evaluate the safety and pharmacokinetics of extended release and standard~     formulations of betahistine when administered as monotherapy and as compared to their safety~     and pharmacokinetics when co-administered with olanzapine and to determine potential dose~     limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety~     of either medication, with particular emphasis on somnolence and weight gain secondary to~     olanzapine treatment~   "
144110|NCT01168323|"~     Two memory research findings (the spacing and testing effects) can dramatically improve~     retention of learning, but they have largely have been ignored by educators. The researchers~     have developed a novel form of online education (termed 'spaced education') based on these~     two effects which has been shown in randomized trials to improve knowledge acquisition and~     boost learning retention. Using prostate cancer screening as an experimental system, the~     researchers investigated whether spaced education could durably improve clinicians'~     behaviors, not just their knowledge.~   "
144111|NCT01168310|"~     This is a randomized, double-blind, multi-dose, parallel group trial which will assess the~     pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with~     COPD.~   "
144112|NCT01168297|"~     In 1995 we conducted a cross-sectional study to identify the effects of traditional and~     western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima~     Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous~     region and at that time had experienced little change from their traditional lifestyle.~     Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in~     the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized~     society and have a high prevalence of diabetes. We found that although T2DM and obesity were~     more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly~     lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population~     studied included a dramatically higher level of physical activity and a diet higher in fiber~     and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and~     Mexican Pimas share a similar gene pool we concluded that even in populations genetically~     prone to T2DM and obesity, their development is determined largely by environmental~     circumstances.~      Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed.~     The electrical supply to the region has increased, cars have become more prevalent and~     grocery stores have appeared. The impact of these changes on T2DM and obesity has not been~     examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM~     and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same~     measures used previously, including height, weight, waist circumference, body composition by~     bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical~     activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the~     same methods as the 1995 study to the previous results and 3) document the frequencies of~     T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and~     non-Pima Mexicans.~   "
144113|NCT01168284|"~     In recent years, there have been a growing number of individuals diagnosed with Autism~     Spectrum Disorders (ASD). As such, this increase has expanded the number of caregivers of~     children with ASD. Research has shown that having a child with an ASD is stressful for~     caregivers and their families. More specifically, prior research suggests that caregivers of~     children with ASD may find it difficult to maintain feelings of control and to cope with the~     overall physical and emotional demands of caring for their child. A previous study of~     caregivers of children with ASD found that caregivers felt a lack of personal control over~     aspects of their child s condition and also found it difficult to cope with various demands~     of caregiving. Furthermore, this study found that greater levels of perceived personal~     control and the use of problem-focused coping strategies were associated with caregivers~     adaptation to their child s condition. As such, the goal of our research is to conduct a~     feasibility study using a coping effectiveness training (CET) intervention designed to~     enhance perceived personal control (PPC) and coping efficacy in caregivers of children with~     ASD. There has been a growing interest in developing interventions targeted at constructs~     involved in the adaptation process. However, there have been few studies of interventions~     targeting predictors of adaptation such as PPC and coping efficacy. Research has shown that~     the CET intervention can enhance coping efficacy in several other populations. This~     intervention also incorporates appraisals of one s ability to change a particular situation.~     The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional~     Model of Stress and Coping. A cross-sectional randomized treatment-control design is~     proposed to evaluate the use of a CET intervention intended to enhance PPC and coping~     efficacy. Caregivers of children with ASD will be recruited from support groups, autism~     resource centers, and four clinics. Participants randomized to the treatment group will be~     asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person~     sessions. Participants randomized to the control group will be asked to complete baseline~     and follow-up surveys and two 1.5-hour individualized in-person client-centered discussion~     sessions. The main outcome measures will be participation, reasons for withdrawal,~     participants experiences within the intervention setting and their experiences in applying~     the intervention, PPC, coping efficacy, and coping effectiveness.~   "
144402|NCT01164501|"~     This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic~     patients with renal impairment in order to provide these data for approval for BI 10773 as~     an antidiabetic agent by regulatory authorities.~   "
144114|NCT01168271|"~     Malaria caused by Plasmodium falciparum continues to be a global problem with devastating~     consequences. A greater understanding of the immunologic and parasitologic factors~     associated with infection and disease is badly needed, and will accelerate the development~     of highly protective vaccines for both mothers and children. Pregnancy malaria is associated~     with low birth weight, maternal anemia, and gestational hypertension, and both inflammation~     and the fetal response to infection may contribute to these poor outcomes. Childhood malaria~     is a major cause of mortality, and we have found that risk of childhood malaria is related~     to in utero exposure to pregnancy malaria, as well as other host factors like iron status~     and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding~     phenotype, and as our primary hypothesis in this study we speculate that severe childhood~     malaria parasites may also have distinct features. A longitudinal cohort study will be~     conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000~     pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed~     to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples~     obtained. In addition, 2000 febrile children up to age 10 years will be enrolled at the~     Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) Pediatric~     Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500~     pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the~     Gabriel Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy~     malaria and preeclampsia. Clinical, parasitologic and host response (including immunologic)~     endpoints will be analyzed using appropriate statistical methods, including possible~     confounders, to determine factors associated with infection and disease in pregnant woman~     and young children.~   "
144115|NCT01168258|"~     Background:~      - Diabetic macular edema (DME) is a common condition in people with diabetes. DME occurs~     when blood vessels in the eye leak fluid, resulting in swelling inside the back of the eye~     and progressive vision loss. Research has shown that good blood sugar control can reduce the~     risk and severity of DME. However, not all diabetic patients with poor blood sugar control~     develop DME, and some patients develop DME despite excellent blood sugar control. This~     suggests that other factors, such as genes or inherited traits, may predispose or protect a~     diabetic patient from developing DME.~      Objectives:~      - To investigate genetic factors that may influence the development of diabetic macular~     edema.~      Eligibility:~      - Individuals at least 18 years of age who have type 2 diabetes, with or without diabetic~     macular edema.~      Design:~        -  The study will require one visit to the National Institutes of Health eye clinic.~        -  Participants will be screened with a medical history and basic eye examination.~          Individuals who have certain eye diseases other than DME may not be allowed to enroll~          in the study.~        -  Participants will provide a blood sample, and will receive fluorescein angiography (an~          injection of fluorescein dye, after which a camera will take pictures of the dye as it~          flows through the blood vessels in the eye).~        -  No treatment will be provided as part of this protocol.~   "
144116|NCT01168245|"~     The aim of this study is to examine if combined treatment with TMS and cognitive training~     (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral~     symptomatology of mild to moderate Alzheimer's disease (AD) patients.~   "
144117|NCT01168232|"~     This phase II trial is studying the side effects and how well ixabepilone works in treating~     patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as~     ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the~     cells of by stopping them from dividing.~   "
144118|NCT01168219|"~     This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate,~     and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in~     treating patients with high-risk myelodysplastic syndrome and older patients with acute~     myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine~     phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It~     also stops the patient's immune system from rejecting the donor's stem cells. The donated~     stem cells may replace the patient's immune cells and help destroy any remaining cancer~     cells (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make~     an immune response against the body's normal cells. Giving anti-thymocyte globulin before~     transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may~     stop this from happening.~   "
144119|NCT01168206|"~     The association of nutritional supplement TK3 to conventional treatment of cancer patients~     reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or~     palliative treatments for the protection of healthy tissues, resulting in a better quality~     of life.~   "
144120|NCT01168193|"~     Surgical complications may be very serious and are often under-reported. The aim of this~     study it to document and study all the postoperative complications at our department during~     one year using a novel grading system.~   "
144121|NCT01168180|"~     The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain~     intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion,~     patient satisfaction and side effects in the treatment of scapulocostal syndrome.~   "
144122|NCT01168167|"~     Recent clinical trials of combination antiretroviral therapy (cART) containing the first~     approved integrase inhibitor (i.e. raltegravir) have demonstrated a more rapid decay of~     HIV-1 RNA in plasma, compared to conventional potent antiretroviral combinations. This was~     observed especially during the early phase (up to week 12) following initiation of cART.~      To explain this, two mechanistic hypotheses have been developed:~        1. - Macrophage reservoir death hypothesis. A major source of virus production during the~          second phase decay are believed to be long-lived infected cells with continuous virus~          production - e.g. macrophages. An accumulation of unintegrated, episomal HIV-1 cDNAs~          can promote apoptosis (Li et al. Embo J. 2001;20: 3272). In case of HIV superinfection~          of such a productively infected cell, an INI-based cART may induce apoptosis and thus~          contribute to a decrease in HIV RNA load during second phase decay. However, no study~          has thus far addressed the consequences of INI treatment on HIV-1 cDNA species on any~          cell population in vivo.~        2. - Resting CD4 T-cell reservoir integration block hypothesis. Resting CD4 T-cells may~          represent a substantial reservoir for HIV replication during the second phase decay as~          well. A special characteristic of these cells is that HIV-1 cDNA is typically localized~          to the nucleus in a not-integrated form (Chun et al., PNAS 1997;94:13193). These~          resting cells likely integrate HIV-DNA upon activation and then contribute to HIV~          viremia and viral spread. Conceptually, integration could be prevented by RGV, but not~          by RTI or PI. An accumulation of circular episomal HIV-1 cDNA species may also be a~          consequence of RGV treatment in this cell type.~      Patient disposition:~      To explore raltegravir-induced shifts in HIV-1 cDNA species in vivo, this non-interventional~     clinical observation investigates the dynamics of the three major HIV-1 cDNA species (total~     HIV-1 cDNA, HIV-1 integrants in the host cell genome, episomal HIV-1 2-LTR circles) over a~     period of 4 months in two groups of patients starting off cART from a single study center.~     Patients who begin cART in regular clinical routine with 2N(t)RTI plus either (n=10~     patients) raltegravir or (n=10 patients) a boosted protease inhibitor/ alternatively an~     NNRTI will be offered to participate in this observation. Only patients are offered to~     participate in this trial if no other antiretroviral drugs than the above mentioned and no~     concomitant drugs with relevant impact on antiretroviral's pharmacokinetics are~     administered. At time of study inclusion, patients should be characterised by a HIV-1 RNA~     load of >5,000 copies/mL and CD4-cell count of >200/µL within 12 weeks before cART~     initiation.~      Preliminary analyses of PBMCs from HIV-infected patients indicate that all three major HIV-1~     cDNA species can be quantified by real-time PCR under these baseline conditions.~   "
144123|NCT01168154|"~     The aim of this study is to evaluate the effectiveness and the tolerability of the~     Lactobacillus reuteri in the control of the diverticular disease symptoms and in the~     prevention of acute diverticulitis episodes.~   "
144124|NCT01168141|"~     This is a prospective study in which patients with castrate-resistant prostate cancer and~     bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where~     possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054,~     an orally active specific endothelin-A antagonist. The samples will be used primarily for~     biomarker studies, and it is hypothesized that these will inform on the mechanism of action~     of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging~     functional imaging endpoints as markers of early response in bone metastatic prostate~     cancer.~   "
144125|NCT01168128|"~     Canadian Critical Care Nutrition Guidelines assist health practitioners in identifying best~     practices for feeding critically ill patients. However, guidelines have resulted in little~     change in Intensive Care Unit (ICU) practices, possibly because barriers to change differ~     between ICUs. Change may be facilitated if strategies specifically address identified~     barriers. The investigators hypothesize that barriers are inversely related to nutrition~     performance. Tailoring change strategies to overcome barriers to change will reduce the~     presence of these barriers and lead to improvements in nutrition practice.~   "
144126|NCT01168115|"~     The purpose of this study is to evaluate the performance of a near-infrared transmission~     measurement in blood samples collected from healthy volunteers. We propose that NIR~     spectroscopic blood glucose measurements in healthy patients are as accurate as handheld~     glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood~     samples spiked with pharmacological interferents to test if the spectroscopic glucose~     measurement is affected by common medications.~   "
144127|NCT01168102|"~     The objective of this study is to assess the performance of a noninvasive device for the~     detection of blood alcohol levels.~   "
144128|NCT01168089|"~     Luminous Medical, the Sponsor is developing a glucose monitor for the critical care setting.~     The Sponsor's ultimate goal is to provide a near-continuous blood glucose monitor that~     automatically measures glucose. In this study, Luminous will evaluate the performance of the~     near-infrared measurement in blood samples collected from patients in the intensive care~     unit setting.~   "
144129|NCT01168076|"~     The objective of this study is to assist in the development of a noninvasive device for the~     accurate measurement of blood glucose levels.~   "
144130|NCT01168063|"~     H pylori eradication failure with recommended triple therapy is mainly related to antibiotic~     resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine~     practice. A molecular test of antibiotic resistance easy to perform is now available. The~     aim of the study was to compare eradication rates obtained with the standard treatment and~     with a treatment guided by the results of the molecular detection of antibiotic resistance.~   "
144131|NCT01168050|"~     NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy~     of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable~     melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective~     is overall response rate (partial and complete response) according to RECIST 1.1 criteria,~     assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months~     therapy with Nilotinib 800 mg/d. Secondary objectives include:~        -  Disease control rate (complete, partial response and stable disease)~        -  Metabolic response~        -  Tolerance NCI CTCAE Version 3.0~        -  Biomarkers associated to response and disease control.~   "
144132|NCT01168037|"~     The aim of this study is to prospectively compare the perioperative mortality severe~     morbidity and the costs of endovascular versus conventional surgical repair of pararenal,~     supra-renal and type 4 THORACO-abdominal aortic aneurysms.~      The primary goal of the study is to demonstrate a significant drop in 30-day mortality and~     life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived~     from the literature, that the average 30-days mortality is 3% after endovascular repair and~     10% after open surgery justifies the design of a prospective study between endovascular~     therapy (250 patients (amendment) treated in 8 University hospitals with significant~     experience of the technique) and open repair (660 similar patients analyzed form the~     national database of the MOH).~   "
144133|NCT01168024|"~     The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey~     Medical CINCOR™ Contrast Removal System.~   "
144134|NCT01168011|"~     This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral~     doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of~     the study is to determine the highest dose of drug that can be given safely. The study will~     start by testing a low dose. If this dose is safe, then, higher and higher doses will be~     tested as long as the previous lower dose was safe. Safety will be determined by looking for~     any side effects or unusual laboratory values. It is important to know the highest safe dose~     so that additional studies can be done. The drug will be given in the form of capsules twice~     or three times a day for 21 consecutive days of 21-day cycles.~   "
144135|NCT01167998|"~     Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date~     atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions~     are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed~     too late. In this study a protein conjugated to a florescent dye is spread on a suspicious~     pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus~     with a special camera that picks up the dye we can find pigmented lesions with early~     malignant transformation.~   "
144136|NCT01167985|"~     The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in~     provisional restoration is going to be examined. Two different tests are planned: (1)~     clinical and radiological evaluation of root canal sealer.(2) An evaluation in the~     laboratory the efficacy of provisional restoration during root canal treatment.We assume,~     based on our previous laboratory studies that show antibacterial properties, that the~     incorporation of the nanoparticels will improve the treatment outcome.~   "
144137|NCT01167972|"~     The main objective of the study is to determine the proportion of patients with M + mutation~     status among patients with Non Small Cell Lung Cancer adenocarcinoma.~   "
144138|NCT01167959|"~     The purpose of this study is to determine the effect of gastric banding or gastric bypass on~     hypothalamic morphology and function, gut hormones and systems biology in obese subjects~     with and without type 2 diabetes.~   "
144141|NCT01167920|"~     This is a prospective, randomized controlled trial designed to determine whether blue tooth~     and telephone technology can be utilized to successfully relaying home blood pressure~     information electronically to healthcare providers so that timely and more frequent~     treatment interventions can be instituted to optimize and reach goal blood pressure level~     for an individual as compared to usual care. The primary study outcomes are improvement in~     systolic, diastolic, and blood pressure control and time to control blood pressure.~     Secondary outcomes are proportion of patients controlled to blood pressure goal at the end~     of the study, adherence to blood pressure monitoring and utilization of VHC model.~      If this is successful and cost-effective such technology and interventions could be utilized~     on large scale to improve the care and proportion of hypertensive patients achieving goal~     blood pressure in the United States.~   "
144142|NCT01167907|"~     A nerve block catheter is a small tube placed next to a nerve through a needle, and the~     needle is then removed. Numbing medicine is dripped through the tube to reduce pain~     sensation from the nerve.~      The purpose of this research study is to test whether the placement of a second nerve block~     catheter, rather than a single injection for the saphenous nerve block will improve pain~     relief and/or reduce pain medication needed after surgery enough to justify two nerve block~     catheters.~      There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve~     and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at~     Wake Forest University typically have a nerve block catheter placed next to the sciatic~     nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single~     injection of local anesthetic is usually performed to block the saphenous nerve for 12-16~     hours postoperatively.~   "
144143|NCT01167894|"~     The purpose of this study is to~        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg~          tablets of MercK & Co. Inc, USA in healthy subjects under fasting conditions~        -  monitor adverse events and to ensure the safety of subjects.~   "
144144|NCT01167881|"~     This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for~     BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2~     diabetes mellitus and insufficient glycaemic control.~   "
144145|NCT01167868|"~     This is a single and multiple ascending dose study in healthy male and female (of non-child~     bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and~     blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid~     arthritis.~   "
144146|NCT01167855|"~     The overall goal of this proposal is to examine the efficacy of a school-based asthma~     telemedicine intervention in a predominately minority, low-income rural pediatric~     population.~   "
144147|NCT01167842|"~     This study will analyze tumor tissue from patients with known genetic mutations (BRCA1,~     BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either~     primary/recurrent, or two different anatomical sites.~   "
144148|NCT01167829|"~     The purpose of this study is to test how the body absorbs a new form of oral testosterone~     (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at~     the University of Washington to monitor blood testosterone levels over a 24-hour period.~   "
144149|NCT01167816|"~     The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and~     gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also~     to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.~   "
144150|NCT01167803|"~     Obesity is increasing in France, resulting in an increased demand for bariatric surgery.~     However obesity also alters physiopathological pathways and the pharmacokinetics of~     anesthestic agents. The investigators objective is to compare, among morbidly obese~     patients, the immediate and intermediary emergence kinetics after balanced anesthesia using~     remifentanil associated either with desflurane (reference arm) or with xenon (experimental~     arm).~   "
144151|NCT01167790|"~     Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for~     diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination~     decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al.~     Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a~     useful technic for detection of dysplasia and squamous cell carcinoma that cannot be seen~     with conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF~     Head Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a~     screening tool for systematic oral examination and the reproductibility has never been~     studied.~   "
144152|NCT01167777|"~     Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification~     assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia~     trachomatis (CT) and Neisseria gonorrhoeae (GC).~   "
144153|NCT01167764|"~     Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is~     no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a~     randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of~     hemoptysis.~   "
144154|NCT01167751|"~     One of the important reasons for human dying is Ischemic heart disease (IHD). The most~     reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and~     necrosis which due to congestive heart failure.~      One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the~     cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method~     to prevent ventricular remodeling after acute myocardial infarction. Human and animal~     studies have shown that stem cell trans plantation to myocardial infarcted zone can improve~     heart contractile function.~      The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation~     in patients with myocardial infarction.~   "
144181|NCT01167400|"~     Exercise has been linked to cognitive health, but few older adults exercise at recommended~     levels. Cybercycling may provide additional cognitive benefits due to increased motivation~     to ride the interactive 3D tours. Participants will be randomly assigned to three months of~     either cybercycling or traditional stationary biking; and they will complete comprehensive~     evaluations before and after exercise. Older adults are expected to show significant~     neuropsychological, physiological and behavioral gains.~   "
144155|NCT01167738|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving more than one~     drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not~     yet known if combination chemotherapy is more effective with or without metformin~     hydrochloride in treating patients with metastatic pancreatic cancer.~      PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin~     hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin~     hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride,~     capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic~     pancreatic cancer.~   "
144156|NCT01167725|"~     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to~     several degrees above normal body temperature and infusing it into the area around the tumor~     may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor~     cells. It is not yet known whether standard therapy is more effective with or without~     surgery followed by mitomycin C.~      PURPOSE: This randomized phase III trial is studying standard therapy with or without~     surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination~     of colon cancer~   "
144157|NCT01167712|"~     This phase III clinical trial studies two different dose schedules of paclitaxel to see how~     well they work in combination with carboplatin with or without bevacizumab in treating~     patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or~     fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of~     drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood~     vessels that tumors need to grow. It is not yet known whether giving paclitaxel with~     combination chemotherapy once every three weeks is more effective than giving paclitaxel~     once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.~   "
144158|NCT01167699|"~     The main objective of the study is to evaluate the patient preference for pain treatment~     with respect to quality of life in patients with moderate to severe non malignant pain.~     Patients who have insufficient pain relief and/or unacceptable side effects with the~     previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can~     be included in the study. The WHO step I or II analgesics will be compared with the new~     study medication OXN (oxycodone/naloxone).~   "
144159|NCT01167686|"~     General:Prospective, randomized, double blind controlled trial of the food supplement~     GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with~     upper respiratory infection.~      Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the~     time to recovery from the disease symptoms.~      Study design and outcome measures:Study population of 182 generally healthy subjects with~     acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo~     treatment, with randomization stratified by site. The study supplement administration will~     be continued for 7 days, and patient global assessment (PGA) will be the main primary~     measurement tool, based on a self-reporting questionnaire filled and monitored every 12~     hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection,~     will be taken at inclusion of patient and a number of blood tests at the end of treatment to~     look for any adverse effects of the medication.~      Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and~     laboratory studies will be analyzed by multivariate analysis to determine the efficacy of~     the supplement and its correlation to the clinical and laboratory parameters.~   "
144160|NCT01167673|"~     Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular~     bowel movements and bloating. It may be caused by loe degree inflammation of the intestine.~     The ingredients of coltect which contains green tea, selenium, and curcumin have been proven~     very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to~     see whether the use of Coltect can improve symptoms in IBS patients.~   "
144161|NCT01167660|"~     The purpose of this study is to assess the reliability of a new non-invasive device to~     assess the blood coagulation status among term and preterm babies.~   "
144162|NCT01167647|"~     Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when~     infections including tuberculosis (TB) are not strongly suspected. However, the value of~     this practice has been poorly defined.~   "
144163|NCT01167634|"~     This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial~     incentives to motivate and sustain long-term weight loss. The study will recruit eligible~     employees at a large health management company to participate in a 6-month weight loss~     program and have weight measurements for an additional 3-month follow-up period. The primary~     outcome measure in this randomized controlled trial will be pounds of weight lost. The~     experimental groups will include variations of deposit contracts (participants put their own~     money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed~     payments. The use of deposit contracts is a powerful mechanism for inducing behavior change~     that is based on loss aversion, a psychological concept first described by Nobel Prize~     winner Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the~     fact that people typically feel the pain of a loss more than the pleasure of a gain,~     increasing ones motivation to reach a goal.~      The study hypotheses are 1) mean weight loss will be greater in all intervention groups~     compared to the control group by the end of 24 weeks; and 2) individuals in the intervention~     groups will have a lower mean weight at the end of the 3-month follow-up period than~     individuals in the control group.~   "
144228|NCT01166789|"~     The purpose of this research study is to determine how Lubiprostone, a medication used to~     treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to~     reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the~     secretion of chloride, water and sodium. The increased fluid causes food residue to move~     through the bowel more quickly and makes the stools softer. First, we want to test the idea~     that Lubiprostone works by making a person less sensitive to pain. Second, we want to~     confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI~     tract, referred to as transit time.~   "
144164|NCT01167621|"~     The study is intended to evaluate the hemodynamic and the indexed extrapulmonary lung water~     (ELWI) changes in patients treated by high frequency oscillation-ventilation (HFO-V) for~     refractory acute respiratory distress syndrome (ARDS). HFO-V may be used as rescue treatment~     in refractory ARDS but its hemodynamic impact is discussed. Moreover, as Extra Vascular Lung~     Water (a transpulmonary thermodilution parameter) was proven to be an independent mortality~     factor in ICU-patients, the investigators decided to monitor it in all ARDS patients who~     ended up needing HFO-V, from HFO-V plugging under 72 hours of this type of ventilation. All~     ARDS patients underwent high Positive End Expiratory Pressure (PEEP) with protective~     ventilation and those who remained below a PaO2/FiO2 ratio of 120 after 24h will be~     considered as refractory ARDS patients and, therefore eligible. They will be monitored by~     the transpulmonary thermodilution PiCCO technique (Pulsion Medical System. Munich, Germany)~     and placed under HFO-V. Both transpulmonary thermodilution measurements (ELWI , Cardiac~     Output, Global End-diastolic Volume) and standard transthoracic echocardiographic~     measurements (Ejection Fraction, End-diastolic Right and Left Ventricular Area, preload~     indexes) were be performed from HFO-V plugging to Day 3. The investigators suggest that ELWI~     will be correlated to HFO-V responsiveness and that cardiac output will not change at the~     HFO-V plugging, regardless of preload indexes variation. Inclusion will be proceeded over a~     2 year period and, according to the population, the investigators expect about 50 eligible~     patients.~   "
144165|NCT01167608|"~     Parkinson's disease (PD) is the second most common neurodegenerative disorder in the~     elderly. In most people, the illness is complicated by co-occurring psychiatric problems~     such as depression and anxiety. These non-motor concerns negatively affect the course and~     management of the disease, often leading to poor outcomes for both patients and their~     families. Despite these deleterious consequences, psychiatric symptoms in PD are both~     underreported by patients as well as under-recognized and under-treated by health care~     providers.~      The primary purpose of this study is to identify and describe barriers to mental healthcare~     utilization for people with Parkinson's disease. Secondary objectives include the assessment~     of attitudes and preferences regarding the need for mental health services in the PD~     community and the acceptability of telehealth interventions as a method for improving access~     and quality of care. In order to accomplish these aims, participants will be asked to fill~     out an anonymous survey which will take about 15-30 minutes to complete. To best accommodate~     PD patients with varying levels of disability, participants will have the option to complete~     the survey online, on paper, or over the phone. The information obtained from this study~     will be used to support future treatment development efforts (i.e., phone and internet based~     interventions, community based trainings with local providers) intended to improve access~     and quality of mental health care for people with PD. To the best of the investigators~     knowledge, this is the first study to systematically examine barriers to mental healthcare~     utilization in PD in a national sample.~   "
144166|NCT01167595|"~     Critically ill patients are consistently underfed. Feeding protocols are standardized system~     tools used to guide nutrition practices, but to date have failed to improve delivery of~     nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American~     Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be~     randomized to implement the PEP uP Protocol and educational intervention, and ten will be~     randomized to continue usual care. Nutrition practices will be reevaluated 6 months after~     baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of~     nutrition, and may ultimately lead to improved survival of critical illness.~   "
144167|NCT01167582|"~     The purpose of this study is to evaluate two approaches to red blood cell transfusion in~     anemic patients with acute coronary syndrome.~   "
144168|NCT01167569|"~     It has been shown that the stress that occurs during cardiac surgery leads to early decrease~     of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to~     complications after surgery.~      This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the~     outcome and complications after cardiac surgery.~   "
144169|NCT01167556|"~     Cannabis use by people with schizophrenia is associated with family distress and poor~     clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to~     help parents to motivate their child with a diagnoses of recent-onset schizophrenia to~     reduce cannabis use.~      In a single-blind randomised clinical trail with 75 patients with the diagnosis of~     schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will~     be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that~     FMI will be more effective than routine care in reducing (a) cannabis use in patients and~     (b) distress and sense of burden in parents.~   "
144170|NCT01167543|"~     This study investigates the prevalence and pathophysiology of dental and periodontal~     involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux~     (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the~     prevalence of oral disease in children with and without a diagnosis or symptoms/signs of~     GERD in a cross-sectional study. Secondary objectives are to examine factors that might lead~     to the pathogenesis of the dental and periodontal lesions observed in this group of~     subjects.~      The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having~     symptoms or signs of GERD have a significantly higher amount of dental erosions in~     comparison to a matched control group.~      Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of~     GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI~     (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering~     capacity.~   "
144182|NCT01167387|"~     Postoperative infectious morbidity remain the most frequent, threatening and costly event~     after major surgery. Maintenance of postoperative euglycemia might be a key factor to~     prevent such complications and given the preliminary data on the positive effect of~     carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If~     this treatment will be proved effective on relevant outcome measure such as rate of~     infections, it might be used routinely and extensively because preoperative carbohydrates~     administration is cheap, simple and applicable by everyone in any surgical ward.~      The aim of the trial is to evaluate if the normalization of blood glucose by means of~     preoperative oral administration of maltodextrine, in patients candidate to elective major~     surgery, may be effective in improve surgical morbidity.~   "
144171|NCT01167530|"~     The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung~     cancer.~      First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one~     week before then during the radiotherapy and will be continued for 3.5 weeks after the end~     of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three~     patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of~     the study:RAD001 (everolimus) will be administered per os every day one week before then~     during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy.~     Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are~     planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be~     conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly~     fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1,~     D8, every 21 days.~   "
144172|NCT01167517|"~     This study will test the effectiveness of breast milk expression discharge instructions in~     digital video disc (DVD) format for home use by mothers of very low birth weight infants on~     the dose and duration of mother's breast milk feeding in their infants compared to breast~     milk expression discharge instructions in printed format. The investigators hypothesize that~     infants whose mothers receive breast milk expression discharge instructions via DVD will~     receive a larger dose of maternal breast milk and for longer duration during the initial~     neonatal intensive care unit hospitalization than infants whose mothers receive discharge~     instructions in printed format.~   "
144173|NCT01167504|"~     The aim of this study is to determine how different ingredients which are found in food and~     other consumer products affect the ability of saliva to form surface films.~      Saliva forms a protective film on the surfaces inside the mouth. This film affects the way~     we consume and digest food and protects our teeth and other surfaces inside the mouth from~     disease and decay. It is not well known how this film forms, or which components in everyday~     life affect formation of the film, and therefore its protective properties.~      Samples of saliva will be collected from apparently healthy volunteers. The properties of~     the film (thickness, density, strength, protein composition) will be studied in the~     laboratory under controlled conditions. The effects of common ingredients in foods and other~     products such as proteins, emulsifiers, preservatives and surfactants on the formation and~     properties of the film will be determined.~      The results of this study will help us to understand how different ingredients can change~     the properties of saliva that may affect the way that we sense and digest food, and the~     ability of saliva to protect against decay and infection. This could, in the future lead to~     new ideas for developing:healthy foods (e.g. lower fat) that taste better, or more effective~     dental care products.~   "
144174|NCT01167491|"~     The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's~     granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an~     assortment of activating NK cell receptors and their signaling partners, in particular~     DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12,~     is the missing link between the different cell components involved in WG (neutrophils,~     macrophages, CD4 T cells).~   "
144175|NCT01167478|"~     The objective of this study is to verify if there is a neurophysiologic reserve when~     caffeine and placebo perceived as caffeine are manipulated in closed- and opened-loop~     exercises. Parameters of excitability level of skeletal muscle and Central Nervous System~     (CNS), and peripheral metabolism will be measured~   "
144176|NCT01167465|"~     The purpose of this clinical observation is to evaluate the safety and consumers'~     satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.~   "
144177|NCT01167452|"~     This study will find how weight affects the dosing of a drug called sulfamethoxazole and~     trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives~     is the same regardless of the patient's weight. The entire cohort was analyzed for the study~     outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data~     analysis.~      All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you~     will receive in this study will be referred to as study medication within this informed~     consent form. This drug is a combination of two antibiotics, sulfamethoxazole and~     trimethoprim, which belongs to a class of medication known as sulfones and is approved by~     the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial~     infections such as ear infections, urinary tract infections, bronchitis, traveler's~     diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given~     orally.~   "
144178|NCT01167439|"~     The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in~     order to identify the best candidates and the proper timing to perform dysphagia alleviating~     procedures in both heterozygote and homozygote patients from the large pool of cases with~     this disease in Israel.~   "
144179|NCT01167426|"~     This is an open-label, multicenter study conducted at approximately 20 sites. Each patient~     will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall~     injection satisfaction.~   "
144180|NCT01167413|"~     Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence~     of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the~     result of increased processing of pain by the central nervous system.~      Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory~     joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.~      Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may~     exist between these conditions. Both disorders typically cause chronic nocturnal back pain~     and disturbed sleep may accompany either condition. In addition,the investigators have~     previously described an increased prevalence of (secondary) FMS among female AS patients.~      This overlap may have important clinical implications since the presence of comorbid FMS may~     lead to increased severity results on commonly used instruments in the evaluation of disease~     activity in AS, such as the BASDAI and BASFI .~      Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published~     updated classification criteria for axial spondyloarthropathy. These criteria, which are~     summarized in table 1, are based on the evaluation of patients suffering from chronic back~     pain with an age of onset of less than 45.~      Objective:~      The objective of the current study is to evaluate the prevalence of axial~     spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.~   "
144183|NCT01167374|"~     Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often~     limited. In most cases, they are not amenable to local therapies including surgery or~     radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall~     survival in this patient group for about 3 months.~      Radiation therapy is a treatment alternative, however, high local doses are required for~     long-term local control. However, due to the relatively low radiation tolerance of liver~     normal tissue, even using stereotactic techniques, delivery of sufficient doses for~     successful local tumor control has not be achieved to date.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose~     profile and the high local dose deposition within the Bragg peak precise dose application~     and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions~     offer an increased relative biological effectiveness (RBE), which can be calculated between~     2 and 3 depending on the HCC cell line as well as the endpoint analyzed.~      Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for~     patients with HCC.~      In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for~     patients with advanced HCC. The study will be performed as a dose-escalation study~     evaluating the optimal carbon ion dose with respect to toxicity and tumor control.~      Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.~   "
144184|NCT01167361|"~     This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections~     in children with symptoms of an upper respiratory tract infection (URTI) or lower~     respiratory tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using~     the FilmArrayTM System, a novel highly sensitive and rapid assay for RV detection. An~     aliquot from the leftover sample remaining after clinical diagnostic testing will be used~     for FilmArrayTM analysis. Patients will be accrued on the study over a one year period.~   "
144185|NCT01167348|"~     The purpose of this study is to examine whether auricular acupressure is effective in~     reducing body weight, waist circumference, or lipid profile.~   "
144186|NCT01167335|"~     This study will assess the efficacy of BGG492 as adjunctive treatment in patients with~     refractory partial onset seizures~   "
144187|NCT01167322|"~     The aim of the present Phase III study is to assess the positive predictive value of NPC-07~     (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and~     pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight,~     3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent~     malignant glioma (WHO grades III/IV).~      Positive predictive value will be confirmed by percentage of patients showing positive tumor~     cell identification in all biopsies taken from areas of strong and weak fluorescence. This~     study will be divided into two stages. After reviewing of the result of safety and~     pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring~     committee, more subjects will receive NPC-07 in Step II.~   "
144188|NCT01167309|"~     The purpose of this trial is to determine the safety and tolerability of ascending single~     and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.~   "
144189|NCT01167296|"~     To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if~     leaving it in the uterus will cause uterine infection.~   "
144190|NCT01167283|"~     This study was designed to test the following hypothesis:~      To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type~     distribution.~   "
144191|NCT01167270|"~     This study will test an intervention program designed to provide developmentally appropriate~     guidance to parents of infants on responsive parenting and healthy lifestyle to see if that~     intervention will prevent rapid weight gain in infancy and overweight at age 3 years.~     Further, compared with control infants, intervention infants will have lower body mass index~     (BMI) percentiles at age 3. The investigators also hypothesize that control infants will~     gain weight more rapidly over time.~   "
144192|NCT01167257|"~     Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is~     antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred~     vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum~     toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and~     large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A~     (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided~     needle injection for refractory OAB.~   "
144193|NCT01167244|"~     The purpose of this study is to observe an improvement in overall response rate in NSCLC~     subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR~     mutation positive or who have had a prior a response.~   "
144194|NCT01167231|"~     The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has~     been associated with a significant reduction of cardiovascular events. Additionally,~     acarbose has been shown to have a beneficial influence on some of the other cardiovascular~     risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia~     by acarbose may be a promising therapeutic strategy for reducing the increased risk for~     cardiovascular disease. Further studies are needed to confirm the influence of acarbose on~     cardiovascular risk factors in the real life setting.~   "
144195|NCT01167218|"~     The purpose of this study is to conduct a Verify now assay to detect platelet aggregation~     defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura~     (ITP) and myeloproliferative disorders (MPD).~   "
144196|NCT01167205|"~     The purpose of this study is to determine whether astaxanthin (ASX) supplementation will~     reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese~     adults.~   "
144197|NCT01167192|"~     The purpose of this study is to determine whether platinum-based chemotherapy (either~     cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective~     in improving response to treatment in triple negative breast cancer patients. This treatment~     is being studied in this type of breast cancer because it does not respond well to commonly~     used treatments such as tamoxifen or herceptin.~   "
144198|NCT01167179|"~     The purpose of this study is to conduct an early evaluation of a nurse-led follow up~     intervention added to the usual medically oriented follow up care. Besides evaluating the~     feasibility and acceptability to patients, the effect on psychosocial adjustment and quality~     of life of patients is determined.~   "
144199|NCT01167166|"~     For patients with leukemia who have not responded to or have progressed after an initial~     response to standard therapy, therapeutic options are limited. Although responses to~     standard regimens do occur, durable remissions are achieved infrequently and current~     regimens are not curative in the majority of patients. Identification of active agents in~     patients with relapsed Acute Myeloid Leukemia (AML) ultimately affords the potential for use~     upfront as a component of induction regimens that may translate to improved outcome.~     Therefore, development of new agents is of critical importance. This study will look at a~     new, investigational agent, ON 01910.Na, to determine if it has the potential to help~     Patients with AML and Acute Lymphocytic Leukemia (ALL) and transformed Myeloproliferative~     Neoplasms.~   "
144200|NCT01167153|"~     The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine~     (EXforge®) with nifedipine, as well as vascular function index.~   "
144201|NCT01167140|"~     This is a prospective, non-randomized study to evaluate the performance of the MyoScience~     Cryo-Touch II device for the treatment of wrinkles.~   "
144202|NCT01167127|"~     The main objective of the study is to observe the OXN treatment of patients with moderate to~     severe non-malignant pain in daily clinical practise with respect to pain relief and bowel~     function. Patients who have insufficient pain relief and/or unacceptable side effects with~     the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy~     can be included in the study.~   "
144203|NCT01167114|"~     In this research study, the investigators are looking to see how effective STA-9090 is in~     treating esophagogastric cancer. The investigators will also evaluate the side effects of~     STA-9090, and examine the relationship between the presence of HSP-90 and how well study~     participants respond to STA-9090. STA-9090 works by blocking a protein in tumor cells called~     HSP90, which is thought to play a role in tumor growth. By interfering with this protein's~     function, STA-9090 may help kill tumor cells. This drug has been used in other research~     studies and information from those other research studies suggests that this agent may help~     to slow tumor growth in esophagogastric cancer.~   "
144204|NCT01167101|"~     Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet~     conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good~     effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized~     controlled study to assess the effect of a combination therapy of rebamipide and proton pump~     inhibitor (PPI) on post ESD ulcer healing.~   "
144205|NCT01167088|"~     The purpose of this study is to investigate whether a new medicine, called mitoquinone, will~     reduce raised liver enzymes due to NAFLD and to see if it is safe.~   "
144206|NCT01167075|"~     The aim of the study is to assess the efficacy and tolerability of the low-volume~     supplement. The investigators randomized critically ill patients to receive Intestamin plus~     Fresubin or Fresubin alone.~   "
144207|NCT01167062|"~     This is a randomized double blind placebo-controlled study that will assess the efficacy of~     Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical~     treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control~     group.~   "
144208|NCT01167049|"~     To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant~     chemotherapy for gastric cancer with liver metastasis only~   "
144209|NCT01167036|"~     The purpose of this study was to determine if using a specialized massage tool was more~     effective than a placebo treatment in relieving pain in the upper trapezius muscle along the~     top of the shoulder.~   "
144210|NCT01167023|"~     The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle~     cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring~     medical intervention compared to placebo for 30 days.~   "
144211|NCT01167010|"~     The primary objective will be to compare the Eurofarma and Alenia formulations regarding~     their impact on the pulmonary function of mild to moderate persistent asthma patients and~     the secondary objective will be to compare the three study formulations regarding the~     clinical control of the symptoms and the patients' compliance to the treatment.~   "
144212|NCT01166997|"~     The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right~     ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1~     (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA)~     as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV~     ratio will be significantly reduced in the treatment arm compared to the control arm.~   "
144213|NCT01166984|"~     The primary objective of this study is to establish the safety profile and maximum tolerated~     dose of AB103 given as a single intravenous infusion or by repeated (5 days) IV infusions in~     healthy volunteers.~   "
144214|NCT01166971|"~     The purpose of this study is to prospectively evaluate postoperative visual and refractive~     parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3~     versus those bilaterally implanted with the Tecnis Multifocal 1-piece.~   "
144215|NCT01166958|"~     Current osteoporosis therapies produce a prompt increase in bone mass, followed by only~     modest or no further subsequent gains. This limitation, known as the remodeling transient,~     reflects the coupling of bone resorption with formation such that interventions impacting~     either of these processes lead to compensatory changes of the other. For example,~     medications which increase bone formation promptly also stimulate bone resorption. Thus,~     given the need to dramatically increase bone mass in patients with osteoporosis, it is~     necessary to uncouple formation and resorption. The investigators believe this to be~     possible using currently existing FDA-approved therapeutic agents, by using a novel,~     sequential approach.~      This pilot project will obtain preliminary data essential to support future work. In this~     study, the investigators will begin to explore the use of sequential anabolic treatment with~     teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose~     that such sequential treatment will allow opening of the anabolic window, the brief period~     of time following initiation of teriparatide therapy in which bone formation exceeds~     resorption.~   "
144216|NCT01166945|"~     The investigators objective is to compare short course (5 days) to long course (14~     days)antibiotics for the treatment of acute bacterial sinusitis in children. The~     investigators hypothesize that short course therapy will lead to more frequent relapses of~     sinusitis and will not reduce resistant organisms.~   "
144217|NCT01166932|"~     Objective: To compare the clinical effectiveness and hospital costs, the initial empirical~     treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community~     Acquired Pneumonia (CAP) severe.~      Methods: Clinical prospective randomized study in children aged two months to five years of~     age with a diagnosis of severe CAP, according to criteria of World Health Organization~     (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu-~     UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency)~     with acute or chronic kidney disease, referred patients receiving antibiotics proposal and~     history of allergy to antibiotics proposed. We included 104 children who were randomized~     into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin /~     Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been~     receiving the same oral antibiotic, and maintaining clinical stability, were discharged from~     hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical~     improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to~     expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and~     hospital costs. Treatment failure was determined by the need to expand the antimicrobial~     spectrum after 48 hours of hospitalization.~   "
144218|NCT01166919|"~     Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular~     malformation involving post-capillary venules which produces a light pink to red to~     dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3~     children per 1,000 live births. Approximately 900,000 individuals in the United States and~     twenty million people worldwide have Port wine stain birthmarks .~   "
144219|NCT01166906|"~     There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or~     inhibit transmission of pain signals to the brain. The gate can be closed by mechanical~     stimuli such as touch and vibration.~   "
144220|NCT01166893|"~     According to the National Burn Repository 2007, the most common type of burn injury is a~     partial thickness burns. The current standard of care for partial thickness burns is two~     weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo~     surgical excision and skin grafting.~   "
144221|NCT01166880|"~     The researcher want to know whether reflections of light can be used to provide real-time~     pictures of blood vessel formation around infants' heads. This approach is called laser~     speckle imaging~   "
144222|NCT01166867|"~     The researcher want to use video signals to monitor heart rate, respiration rate and oxygen~     saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method:~     periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured~     using light.~   "
144223|NCT01166854|"~     The researcher wants to explore the genetic causes of muscle disease. The researcher is~     particularly interested in muscle disorders that occur in combination with diseases of bone~     that appear to be passed on from generation to generation.~      Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids~     (fats, for example) in your tissues. This device essentially measures the color of tissues~     in order to determine tissue physiology (its physical and chemical processes).~   "
144224|NCT01166841|"~     The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to~     allow access to the heart through a small incision in the right chest. This avoids the use~     of a sternotomy incision through the bone in the front of the chest. The benefits of such an~     approach are cosmetic (smaller incision not easily visible) and faster recovery. The~     minimally invasive approach also eliminates the risk of sternal wound infection. Minimally~     invasive cardiac surgery however poses additional challenges; one of the biggest is access~     to the large blood vessels which need to be cannulated to allow the heart lung machine to~     function. In conventional surgery, these vessels are easily accessed as they are entering or~     leaving the heart. In minimally invasive surgery, the cannula are placed into easily~     accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller~     than those by the heart and so require smaller cannula, which provide challenges to the~     heart lung machine. One way around this is to use more cannulae and so cannulation of a vein~     in the neck is also performed. This cannula however, has been associated with neck hematoma,~     tearing of the vein and blood loss. While placement of the cannula in the neck is routine at~     LHSC now, when this surgery was first performed here 10 years ago, it was done so without~     the neck cannula and with no injury to patients. The purpose of this study therefore, is to~     more rigorously study the effect of the neck cannula on heart lung bypass, and more~     specifically to see if oxygen delivery to the organs, and the brain in particular is~     sufficient to avoid hypoxia.~   "
144225|NCT01166828|"~     NRI research focuses on nursing interventions that are patient-centered, culturally~     congruent, cost-effective and outcome-driven. High priority populations of interest are~     veterans with Spinal Cord Injuries (SCI). The development of innovative tele home techniques~     for preventing pressure ulcers in veterans with SCI is of high importance in the VA. Our~     findings may provide clinicians with improved methods for skin and wound assessment and more~     effective and efficient PUP strategies for Hispanic and non Hispanic veterans. The new model~     for primary care, the patient-centered Medical Home provides an exciting change in the VA~     that can benefit from the proposed project.~   "
144226|NCT01166815|"~     Zinc deficiency is prevalent in children in developing countries. Zinc-supplementation is~     proven to reduce the duration and severity of childhood diarrhea in randomized controlled~     trials. However, despite this evidence, its efficacy to reduce diarrhea morbidity in adults~     remains unknown. The main objective of this study is to determine the efficacy of~     Zn-supplementation on diarrhea incidences in a vulnerable adult population. The study will~     be carried out in Kombewa division, Kisumu District and will involve 500 adults aged 18-55~     years. They will be randomly assigned to receive Zn supplement (or placebo) on a daily basis~     over a 3 month period. Morbidity information will be collected daily for 4 months, while~     anthropometric measures and laboratory data will be obtained at study onset, end of~     supplementation and study conclusion. In addition, HIV and malaria tests will be carried out~     during the study as they are important confounders. The significant differences in diarrhea~     incidence between the Zn-group and the placebo-group will be determined using SPSS. The~     results are expected to provide the scientific basis and common pathway for development of~     an anti-diarrheal supplement for vulnerable populations such as environmental refugees,~     deprived and displaced persons, and troops prior to deployment.~   "
144230|NCT01166763|"~     The overall goal of this project is to determine if high dose vitamin D3 given to~     premenopausal women at high risk for development of breast cancer, who initially have~     insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50~     ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and~     favorably modulated?~   "
144231|NCT01166750|"~     This study is a randomized wait-list controlled trial with repeated measures. There will be~     two groups: (1) standard medical care (wait-list control), and (2) standard medical care~     plus the adjunctive Jointstrong pain coping skills CD-ROM program (treatment). The study~     will have four phases: Pre-intervention Baseline (2 weeks); Intervention (4 weeks);~     immediate post-intervention follow up (2 weeks); and 12-week post-intervention follow up (2~     weeks). The purpose of this study is to determine if using a CD-ROM program for juvenile~     arthritis can help children learn how to improve their symptoms on their own and reduce the~     frequency of symptoms.~   "
144232|NCT01166737|"~     It is still not clear whether a positive AGO-score just selects patients with less~     aggressive biologic tumor behavior who as well would have had a positive outcome by~     chemotherapy only, or , if it is a score selecting patients who really benefit from surgery.~     Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of~     ending with residual tumor after surgery for recurrent disease. This could avoid including~     patients into the present surgical protocol who could not benefit from an operationThe goal~     of this third DESKTOP study is to evaluate in a prospectively randomized multicentre~     setting, whether maximum effort of cytoreductive surgery followed by platinum based~     combination chemotherapy can improve overall survival as compared to platinum based~     combination chemotherapy alone in AGO-score positive patients.~   "
144233|NCT01166724|"~     The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid~     based triple therapy regimen leads to long term improved/stabilized graft function~     (glomerular filtration rate, GFR) primarily as a consequence of halting CNI-induced~     fibrogenetic processes that mediate loss of functioning renal tissue. The investigators~     further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic~     processes that promote epithelial to mesenchymal transition (EMT) (mediated by TGF- ƒÒ) and~     that early therapeutic intervention may reverse this process (mediated by BMP-7)4.~      To address these hypotheses the investigators propose the following clinical and mechanistic~     aims:~      The investigators will test the hypothesis that switching from Tac to SRL in a Tac based~     triple therapy regimen with MMF and steroids in living and or deceased donor renal~     transplant recipients leads to improvement in allograft structure and function at 2 years~     post-transplantation.~      The investigators will test this hypothesis in an open label controlled trial where stable~     renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will~     undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a)~     Remain on Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue~     MMF and prednisone. The investigators will then compare biopsy derived measures of allograft~     fibrosis (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups~   "
144234|NCT01166711|"~     The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent~     Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium~     Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please~     (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.~   "
144235|NCT01166698|"~     The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled~     administration of single and multiple increasing doses, and to estimate the maximum dose~     that is tolerated in healthy people.~   "
144236|NCT01166685|"~     Background:~      Retrospective analyses of long-term BASKET findings identified patients with large~     drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac~     death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new~     bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched~     to test their comparative clinical safety up to 12 years if treated with an~     aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to~     clopidogrel in a large ACS trial.~      The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to~     the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in~     diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel~     and aspirin~      Set-up:~      Multicenter open-label randomized trial.~      Patient inclusion:~      Unselected series of patients in need of large (>3mm) stents only in native vessels~     irrespective of clinical indication.~      Patient exclusion:~      In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months,~     increased bleeding risk, no compliance expected, History of stroke or transient ischemic~     attack (TIA).~      Randomization:~      By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.~   "
144237|NCT01166672|"~     The purpose of this study is to establish feasiblity of recruiting obese breast cancer~     survivors at the end of treatment, getting those survivors to lose weight and attend~     follow-up visits for 6 months.~   "
144238|NCT01166659|"~     The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation~     as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary~     open angle glaucoma (POAG) who have failed at least one class of topical medical therapy~   "
144239|NCT01166646|"~     The purpose of this study is to determine whether the investigational lotion is an effective~     treatment of moderate to severe plaque psoriasis in comparison to an approved cream.~   "
144240|NCT01166633|"~     Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely~     leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive~     monitoring is required.~   "
144241|NCT01166620|"~     To quantify the incremental cost of infections in patients treated with etanercept,~     adalimumab or infliximab versus abatacept.~   "
144308|NCT01165736|"~     The purpose of this study is to calculate the pharmacokinetics (concentration of compound in~     and rate of excretion from the blood) following a very low dose of compound which will not~     have any pharmacological activity and to monitor for the safety and tolerability of each of~     the compounds in the study.~   "
144309|NCT01165723|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.~   "
144242|NCT01166594|"~     When a patient with glaucoma who has a pressure that is too high and causing damage to their~     vision, despite receiving the maximum amount of medication that can be tolerated, the~     decision is made to have glaucoma surgery. Trabeculectomy is the most common form of~     glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is~     created in the eye and partially covered with a flap of tissue. This new opening allows~     fluid to drain out of the eye bypassing the clogged drainage channels that are~     malfunctioning in patients with glaucoma. Studies have found that trabeculectomy~     significantly reduces vision loss and lowers eye pressure.~      However, many people need another trabeculectomy or other glaucoma surgery because the~     surgery may fail either early or much later because the body closes the drain created by the~     surgeon. The surgery is also less likely to work in patients with darker pigmentation,~     children who have congenital glaucoma, people with difficult to control glaucoma with new~     blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result,~     the investigators need to find ways to improve the longterm survival of trabeculectomy~     surgery in all patients.~   "
144243|NCT01166581|"~     The primary goal of this study is to determine if preoperative breast MRI findings resulted~     in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy~     in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is~     defined as breast tumor size less than 5 cm.~      The objectives are to:~        -  Review early stage breast cancer patient cases treated at Summa Akron City Hospital~          between 2006 and 2009 to evaluate clinical and pathological staging~        -  Determine the results of preoperative breast MRI and the impact on type of surgery~          performed~        -  Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or~          patient decision and if this decision was based on breast MRI findings~   "
144244|NCT01166568|"~     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision~     in patients who require reading glasses.~   "
144245|NCT01166555|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921~     administered as a single subcutaneous dose in healthy volunteers.~   "
144246|NCT01166542|"~     The purpose of this Phase 3 study is to evaluate overall survival and progression free~     survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in~     combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients~     with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.~   "
144247|NCT01166529|"~     Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the~     abdominal pain associated with pancreatic malignancy and other conditions, and is usually~     undertaken at a late stage in the disease process, when analgesic options have been largely~     exhausted or have led to significant and often unacceptable side effects. Until recently,~     CPN was most commonly performed under radiographic guidance; however, in the last 10 years,~     CPN has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case~     series have demonstrated the efficacy and safety of this technique when used to treat the~     pain associated with pancreatic malignancy and/or chronic pancreatitis. However, the~     efficacy of EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies~     has yet to be described. The goal of this study is to assess the efficacy of EUS-guided CPN~     in the management of pain in patients with abdominal non-pancreatic malignancies. Our~     hypothesis is that EUS-guided CPN will provide adequate pain relief in these patients.~   "
144248|NCT01166516|"~     Study to collect post-market safety data for HUD IBV Valve System, a device to control~     prolonged air leaks of the lung, or significant air leaks that are likely to become~     prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on~     post-operative day 7 is considered prolonged unless present only during forced exhalation or~     cough. An air leak present on day 5 should be considered for treatment if it is:~     1)continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon~     normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.~   "
144249|NCT01166503|"~     The goal of this study is to determine whether corrective surgery done earlier than the~     current standard can better improve the visual and eye movement deficits in children with~     infantile esotropia (crossed eyes in infancy).~   "
144250|NCT01166490|"~     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and~     tolerability of ASG-5ME and identify the maximum tolerated dose in patients with~     pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and~     tolerability in patients with relapsed or refractory gastric adenocarcinoma.~   "
144251|NCT01166477|"~     The Study will help to compare the Quality of Life for those HIV patients that are on~     monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor~   "
144252|NCT01166464|"~     The primary goal of this study is to use qualitative interviews and focus groups to aid us~     in adapting a face-to-face smoking cessation intervention for delivery through text~     messaging. After design is completed, the intervention will be pilot tested with a sample of~     young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of~     treatment) and both 3 and 6 month follow up.~   "
144253|NCT01166451|"~     The purpose of this clinical trial was to determine if high-iron or low-iron formula,~     containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron~     status in infancy and on development longitudinally.~   "
144265|NCT01166295|"~     Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain~     (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully~     understood, and medication trials for PHN pain and other types of NP are frequently~     unsuccessful.~      There has been extensive investigation aimed at identifying and understanding the specific~     mechanisms of NP. While some of these tests are inexpensive and easy to perform at the~     bedside, many require expensive tools and highly equipped laboratory facilities. Further,~     there is no standard method for assessment of pain in NP patients.~      The investigators aim to test a Bedside Sensory Testing Kit (assessment for Neuropathic~     Pain) on a small number of patients with PHN.~      The purpose of the Kit is to identify mechanisms of pain. The goal of this research is to~     design a way to classify patients with PHN based on what mechanisms are causing their pain,~     since this may help predict the best medications for individual patients.~   "
144254|NCT01166438|"~     Urinary incontinence is a prevalent condition that markedly impacts quality of life and~     disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms~     of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge~     incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined~     with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/-~     biofeedback, or the use of anticholinergic medications. These treatment modalities may not~     result in total continence and often drug therapy is discontinued because of lack of~     efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy~     and pelvic muscle exercises require consistent, active intervention by the patient which is~     often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study~     (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox~     A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge~     urinary incontinence. The null hypothesis is that there is no difference in the change from~     baseline in average number of urge urinary incontinence episodes over 6 months between~     groups.~   "
144255|NCT01166425|"~     Study Design This is the second study of a multiphase, multicenter trial that will~     comprehensively examine lithium in the treatment of pediatric participants with bipolar I~     disorder. In order to examine the treatment of bipolar disorder with lithium, this study~     will include four phases of treatment. The first phase, the Efficacy Phase, will include~     participants being randomized to either lithium or placebo for 8 weeks to determine the~     efficacy of lithium in the treatment of children and adolescents with bipolar I disorder.~     Once participants complete the Efficacy Phase, participants may be eligible to continue in~     the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment.~     Subsequently, participants meeting response criteria during the Long-Term Effectiveness~     Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation~     Phase, participants will be randomized to either placebo or lithium treatment for up to 28~     weeks. Finally, those participants who experience a mood relapse during the Discontinuation~     Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for~     up to 8 weeks.~   "
144256|NCT01166412|"~     WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study~     drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel~     (LNG) in a time-release form. LNG is a hormone that has been tested and been approved by the~     Food & Drug Administration (FDA) in other forms, for example: contraceptive pills,~     intrauterine devices (IUDs, which are put in the uterus (womb)) and implants (drug in~     silicon tubing placed under the skin). The use of LNG in the form of a contraceptive patch~     makes this an experimental drug because the way the drug will be absorbed in the body is a~     new technique. This study drug does not contain estrogen and it does not protect against~     HIV, AIDS, or any other sexually transmitted diseases (STDs).~      LNG is a progestin (a type of drug that is like a hormone. Progestins can cause changes at~     the opening of the uterus (womb), such as thickening of the cervical mucus (fluid). This~     thickened cervical mucus makes it difficult for the male's sperm to reach and fertilize the~     woman's egg. Since LNG is being absorbed through your skin from the patch, it is~     experimental, and it is unknown if this study product will really prevent pregnancy like~     other progestins.~      WHY IS THIS STUDY BEING DONE?~      The purpose of this study is to find out:~        -  How well the patch prevents pregnancy~        -  How safe the patch is to use every day~        -  How much study drug needs to be in the patch to make sure that it prevents pregnancy~        -  How the study drug in the patch affects cervical mucus (fluids)~        -  How the study drug in the patch affects your rate of ovulation (how often you release~          an egg)~        -  How well the patch sticks to your skin, without falling off, for a week at a time~        -  Whether the patch causes any skin irritation or rash (redness or itchiness)~        -  Whether the study drug in the patch affects your everyday life and if it causes any~          side effects.~      WHAT DOES THE STUDY INVOLVE? We expect that there will be approximately twenty (20) women at~     each of the six (6) participating clinics in the study. In total, there will be about 120~     women from all over the United States who will be in this study. This study is comparing the~     effectiveness of two different doses of the study drug (40ug and 75 ug) in the patches. This~     study is an open-label randomized trial, meaning that you and your study doctor will be~     aware of the dosage of study drug that you will be given. Randomization means that you will~     be selected by chance, like tossing a coin or rolling a dice. You have a 50% chance of being~     in the group that receives the 40ug dose patch or the group that receives 75ug dose patch.~   "
144257|NCT01166399|"~     The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12~     and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks~     postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms~     of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and~     mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence~     Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question~     from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects~     will be enrolled.~   "
144258|NCT01166386|"~     More than 1.4 million people a year in the United States begin confronting life with the~     medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI).~     A range of cognitive impairments commonly observed following injury increase caregiver~     burden as well as per-person lifetime costs for care and support of survivors of TBI,~     estimated at $600,000 to $1,875,000. Our long-term goal is to lessen these burdens through~     improving the functional status of patients with TBI by providing an evidence-based,~     comprehensive, brief, acute-care intervention, First Steps Acute Neurobehavioral and~     Cognitive Intervention (FANCI). The 10-sesson, manualized FANCI Program will be tested in a~     controlled, randomized study. Therapeutic components of the FANCI include didactics,~     cognitive remediation, demonstration, guided self-reflection, rehearsal, and supported~     practice of skills and strategies. Specific hypotheses are that 1) FANCI will result in more~     improvement in functional status compared to standard interdisciplinary rehabilitation~     treatment and 2) FANCI will result in more improvement on measures of neurobehavioral~     functioning compared to standard rehabilitation care for patients with moderate to severe~     TBI. We base these hypotheses on the observations that 1) providing information about~     symptoms, treatment, and coping results in reduced symptom intensity and duration for~     patients with TBI, and 2) inpatient participants in recent FANCI pilot studies learned >80%~     of the FANCI Program curriculum, and 3) the most recent pilot study participants had~     significantly better functional outcomes at discharge than matched controls. The specific~     aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional~     status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome~     measures of general emotional and behavioral functioning and productive activity in the~     community as measured post-treatment and at 6-month follow-up, 3) examine contributions of~     participant injury severity and cognitive status at time of treatment to treatment outcome~     and treatment response, 4) examine contributions of treatment variables of session topic and~     mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment~     response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily~     compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE),~     Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale~     (FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We~     will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI~     based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI~     rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.~   "
144266|NCT01166282|"~     The purpose of this study is to evaluate the efficacy and safety of adalimumab given~     subcutaneously every other week (eow) as compared to placebo in pediatric subjects with~     Enthesitis Related Arthritis (ERA).~   "
144322|NCT01165554|"~     To determine the level of association between quantitative regional estimates of brain~     uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain~     levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.~   "
144323|NCT01165541|"~     The purpose of the study is to test whether taking two medicines (quetiapine and~     mirtazapine) is better for helping people to decrease drinking than taking one medicine~     alone (quetiapine).~   "
144259|NCT01166373|"~     Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for~     OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study~     and no new study treatment interventions will be given. Rather an enrollment intervention~     will be investigated with potential E-OPTIMAL participants randomly assigned to watch a~     standardized video prior to consent or undergo the standard informed consent process. The~     standardized video will review the rationale for women's health research, the importance of~     long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has~     undergone review by potential subjects, coordinators and physician researchers to ensure~     that the relevance and importance of issues potentially impacting on long-term participation~     in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three~     additional years. Women will be strongly encouraged to participate in annual examinations~     and annual telephone surveys but may participate in only one of these study parts if needed.~      We propose to test the following null hypotheses:~        1. There will be no difference in time to surgical failure between uterosacral vaginal~          vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years~          after surgery.~        2. The addition of a standardized video detailing the importance of long-term follow-up~          studies for POP to the informed consent process will not improve enrollment or~          retention in E-OPTIMAL.~   "
144260|NCT01166360|"~     Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging~     humoral markers for risk stratification in clinically stable heart failure patients and in~     patients with stable coronary artery disease. No data are available about the prognostic~     value of these peptides in relation to mortality and morbidity in patients undergoing~     cardiac surgery.~      Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to~     a standard preoperative risk score, the additive Euroscore for the prediction of 30 day~     mortality and postoperative morbidity in patients scheduled for cardiac surgery.~      Secondary objectives are to test the predictive value of hsTNT, either alone, or in~     combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and~     preoperative cerebral oxygen saturation (ScO2) levels.~   "
144261|NCT01166347|"~     The purpose of this study is to determine the safety and effectiveness of the HeartWare~     Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left~     ventricular failure who have received and failed optimal medical therapy, and who are~     ineligible for cardiac transplantation.~   "
144262|NCT01166334|"~     Would you like to quit smoking?~      Seattle's Fred Hutchinson Cancer Research Center is launching a new study that may be able~     to help. Participants who enroll in this study will be randomly assigned by computer (like~     flipping a coin) to one of two online programs. The goal of this study is to learn which of~     these programs is the most effective at helping people stop smoking. Findings from this~     study will be used to help build more effective online smoking cessation programs in the~     future.~      Participants in both of the smoking cessation programs used in this study will receive:~        -  Interactive tools for dealing more effectively with urges to smoke~        -  Step-by-step guides for quitting smoking~        -  Personalized plans for quitting and remaining smoke-free~        -  Electronic links for reaching one-on-one expert help for quitting~      Participants will be asked to complete online questionnaires, including a brief three-month~     follow-up survey.~      There is no cost for participating in this study.~      To enroll in this study or for more information, please visit www.webquit.com.~      This study is being conducted by Seattle's Fred Hutchinson Cancer Research Center~     (www.fhcrc.org), a world leader in advancing the prevention, diagnosis and treatment of~     cancer. The principal investigator for the WebQuit smoking cessation study is Dr. Jonathan~     Bricker, a faculty member at both the Hutchinson Center and at the University of Washington~     in Seattle.~   "
144263|NCT01166321|"~     Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical~     resection. With this approach, local control ranges between 50 and 70%, depending on~     resection status. A series or smaller studies has shown that postoperative radiotherapy in~     this patient population can increase progression-free survival, which translates into~     increased overall survival. However, meningiomas are known to be radioresistant tumors, and~     radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose~     profile and the high local dose deposition within the Bragg peak precise dose application~     and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions~     offer an increased relative biological effectiveness (RBE), which can be calculated between~     2 and 5 depending on the cell line as well as the endpoint analyzed.~      First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion~     radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results~     are promising.~      Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the~     macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the~     clinical target volume (CTV) in patients with atypical meningiomas after incomplete~     resection or biopsy.~      Primary endpoint is progression-free survival rate, secondary endpoints are overall~     survival, safety and toxicity.~   "
144264|NCT01166308|"~     Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy,~     or radiation therapy. In most cases, a full course of radiotherapy has been applied after~     primary diagnosis, therefore application of re-irradiation has to be applied cautiously.~     With modern precision photon techniques such as fractionated stereotactic radiotherapy~     (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of~     22, 16 and 8 months for recurrent WHO grade II, III and IV tumors.~      Carbon ions offer physical and biological characteristics. Due to their inverted dose~     profile and the high local dose deposition within the Bragg peak precise dose application~     and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions~     offer an increase relative biological effectiveness (RBE), which can be calculated between 2~     and 5 depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed.~     Protons, however, offer an RBE which is comparable to photons.~      First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of~     primary high-grade gliomas showed promising results in a small and heterogeneous patient~     collective.~      In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared~     to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in~     patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose~     (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the~     subsequent randomized Phase II part, the RD will be evaluated in the experimental arm,~     compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.~      Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II~     is survival after re-irradiation at 12 months, secondary endpoint is progression-free~     survival.~   "
144280|NCT01166100|"~     The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride~     Delayed-Release Capsules, 90 mg and Prozac ® weekly under fasting conditions.~   "
144267|NCT01166269|"~     The purpose of the study is to try a new route for specific immunotherapy (SIT). The current~     treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50~     injections subcutaneously in the upper arm.~      The investigators believe that there is additional effect if the allergen is injected~     directly into the lymph node, since it is here, the allergen presentation is happening. The~     trial has been performed in Switzerland with significant effect of only three injections of~     grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).~      The investigators would like to see what happens if the the dose is doubled, so the patients~     will receive 6 injections all in all, with the same amount of allergen as the earlier study~     (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note~     their symptoms in a diary.~      The patients will be divided into three groups using allocation:~      1 group with 6 injections of allergen~      1 group with 3 injections of allergen and 3 injections of placebo~      1 group with 6 injections of placebo. The trial will be double blinded.~   "
144268|NCT01166256|"~     Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However,~     invasive mechanical ventilation is associated with a variety of complications. Non-invasive~     ventilation has been presented as an alternative treatment but controversy remains. The~     investigators hypothesize that high-flow nasal cannula system is effective enough to prevent~     intubation in acute hypoxemic respiratory failure and not inferior to non-invasive~     ventilation.~   "
144269|NCT01166243|"~     The objective of this study is to evaluate the safety and and hemostatic effectiveness of~     the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal~     bleeding during hepatic surgery.~   "
144270|NCT01166230|"~     The study is intended to investigate whether the improved initial detection and resection of~     bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix~     (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences~     compared to standard white light cystoscopy/TURB.~   "
144271|NCT01166217|"~     PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The~     primary purpose of this trial is to evaluate the relative bioavailability of three different~     oral dose formulations of PF-04620110.~   "
144272|NCT01166204|"~     Our group has shown that increasing the radiation dose to pre-specified normal tissue dose~     constraints could lead to increased TCP with the same NTCP in patients with non-concurrent~     and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in~     a prospective study in patients with stage I-III NSCLC, who are selected for high-dose~     radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has~     become standard, but the patterns of recurrence and the possibility for dose-escalation in~     an individualised setting have never been investigated properly.~   "
144273|NCT01166191|"~     The investigators' group was the first to perform a phase II trial in patients with limited~     disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the~     fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were~     irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all~     patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT~     techniques have become more standard in lung cancer. Because of the lower radiation dose to~     the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of~     isolated nodal failures may occur. In this trial, the investigators will investigate the~     patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage~     I-III SCLC.~   "
144274|NCT01166178|"~     This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg~     intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis~     and to support the optimal use of zoledronic acid for this indication. Primary objective is~     the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region~     assessed by T-Score at month 12 relative to screening as measured by Dual X-ray~     Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label~     treatment phase to assess long-term efficacy and safety of zoledronic acid in these~     patients.~   "
144275|NCT01166165|"~     High blood pressure is related to increased risk of cardiovascular disease and death, and~     accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a~     seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is~     more common during months where UVB radiation from the sun is absent, and vitamin D has been~     associated with high blood pressure. This study will evaluate the effect of vitamin D~     replacement during winter months on blood pressure and vasoactive hormones in patients with~     high blood pressure.~   "
144276|NCT01166152|"~     The purpose of this study is to develop a new diagnostic method for developmental disorders~     based on behavior recording during the interview of the subjects by medical staff as well~     anonymous persons. The behavior recording by video camera will be accompanied by~     non-invasive physiological recordings, including electroencephalogram (EEG),~     electrocardiogram (ECG), electromyogram (EMG), and body temperature using infrared (IR)~     thermograph. Thus, the physiologically relevant and the disorder correlated behavior~     parameters could be extracted and used as new diagnostic markers. If necessary, the medical~     staff may take blood sample from the subject before and after the interview. For the~     longitudinal study, the similar interview and the recording of the same subject will be~     planned to evaluate the effect of the medical and educational intervention. The~     investigators also examine the synergistic effect of the intervention and the administration~     of the supplement (e.g., vitamin D, arachidonic acid, coenzyme Q10 (CoQ-10)). The clinician~     may use Risperidone.~   "
144277|NCT01166139|"~     A phase IIa open-label single center pilot study to assess the safety and efficacy of~     Nilotinib in patients with Scleroderma.~   "
144278|NCT01166126|"~     The purpose of this study is to find out how often two investigational drugs that are given~     together will shrink the patient's tumor and how well they will prolong the time it takes~     their tumor to grow. The investigators also wish to find out how they affect certain~     substances in the patient's tumor and in their blood important for tumor growth. The~     combination of these drugs is experimental, and has not been proven to help treat melanoma~   "
144279|NCT01166113|"~     This study will evaluate if the combination of Pomalidomide, Cyclophosphamide and Prednisone~     is safe and provides benefits in patients with multiple myeloma relapsed and/or refractory~     to lenalidomide.~   "
144283|NCT01166061|"~     Grass pollen allergens are universally recognised as a major cause of allergic diseases in~     humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis.~     Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and~     between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.~      ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine,~     currently being developed for the treatment of grass allergy.~      The purpose of the present study is to evaluate the safety and tolerability of multiple~     ascending doses of ToleroMune Grass in subjects allergic to grass.~   "
144284|NCT01166048|"~     Objective:~      The objective of this study is to compare the efficacy of duloxetine in the treatment of~     patients with chronic low back pain with a radicular component to placebo.~      Study hypothesis:~      Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has~     proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials.~     The investigators therefore hypothesize that duloxetine will be efficacious in patients with~     chronic low back pain and a radicular component.~      Study Rationale:~      Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the~     condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in~     patients with neuropathic pain and may also be useful in chronic low back pain. If the~     investigators are able to show a benefit for patients in the duloxetine arm, the substance~     may constitute a further treatment alternative in chronic low back pain.~      Study Design:~      Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be~     administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they~     will be medicated with placebo for 4 weeks. A second group of patients will receive the~     medication in reversed order. The primary study endpoint is constituted the weekly mean of~     VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use~     of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36~     score and side effects/adverse events.~   "
144285|NCT01166035|"~     This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in~     combination with cetuximab in subjects with solid tumors. The primary objective is to~     establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in~     patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the~     head and neck (SCCHN) and non-small cell lung cancer (NSCLC).~   "
144286|NCT01166022|"~     This study is being conducted to test whether exercise can be effectively used as an~     intervention to treat Spinal Muscular Atrophy (SMA). In order to answer this question, the~     investigators will enroll 14 subjects with SMA between ages 8 and 50 and ask them to~     complete an 18 month training schedule. At some points subjects will be asked to closely~     follow a specific training regimen and at other points they may be asked to exercise in the~     same manner they do normally. The exercises they will be asked to perform include biking on~     a stationary cycle and lifting hand weights. Subjects will be asked to come in to the clinic~     seven times over the course of the study to perform tests. These tests include motor~     function measures, a physical exam, questionnaires, a exercise capacity test which involves~     riding a stationary bicycle, and test where the subject is asked to walk as far as they can~     in six minutes. The main goal of the study is to see if the subjects who participate in the~     exercise protocol have larger increases in the distance they can walk in six minutes than~     those who do not.~   "
144287|NCT01166009|"~     The primary purpose of the Research Database is to have a comprehensive source of~     observational data that can be used to study HSC transplantation.~      A secondary purpose of the Research Database is to have a comprehensive source of data to~     study marrow toxic injuries.~      Objectives:~      To learn more about what makes stem cell transplants work well, such as determining the~     following:~        -  how well recipients recover from their transplant~        -  how recovery after a transplant can be improved~        -  how access to transplant for different groups of patients can be improved~        -  how well donors recover from the collection procedures~   "
144288|NCT01165996|"~     RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells.~     PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating~     patients with myelodysplastic syndrome.~   "
144289|NCT01165983|"~     The purpose of this research is to study and determine the effects of Aliskiren on blood~     vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial~     function by 30% or more in comparison to the placebo group.~   "
144290|NCT01165970|"~     Symptomatic hyposalivation is associated not only with Sjögren`s syndrome or salivary gland~     hypofunction in elderly patients, but also with medications containing antimuscarinic drugs,~     chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson & Ava,~     1994, Kielbassa et al., 2006).~      Human saliva possesses important physiological functions in protecting and moistening the~     oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation~     causes oral dysfunction and promotes severe oral side effects (reduced antibacterial~     function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These~     have been identified as being responsible for the rapid destruction of the dentition~     (Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms~     in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen & Veerman,~     2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa,~     these products should also protect dental hard tissues. However, in vitro studies revealed~     that some marketed products have only a neutral or even a demineralising potential on enamel~     as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al.,~     2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have~     been added to saliva substitutes in order to enhance their remineralising property or~     minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most~     patients suffering from hyposalivation are elderly people, recessions and subsequently~     exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an~     earlier and more severe demineralisation can be expected (Saunders & Meyerowitz, 2005).~      Therefore, the current in situ study was performed to assess the effects of a demineralising~     and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was~     hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in~     pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not~     result in enhanced remineralisation when combined with a remineralising artificial saliva~     (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg,~     Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a~     difference.~   "
144310|NCT01165710|"~     The ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to~     identify real world treatment patterns of atrial fibrillation. The registry will describe~     this patient population with regards to demographics, clinical factors, risk stratification,~     and geographic regions. In particular, attention will be focused on the utilization,~     effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The~     registry is designed to identify reasons and risk factors for non-receipt of anticoagulation~     (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take~     them.~   "
144291|NCT01165957|"~     The purpose of this study is to determine the amount of polyethylene wear associated with~     knee replacement designs that incorporate either a fixed or mobile bearing. Tibial~     polyethylene inserts retrieved from modular total knee replacements during revision~     operations will be analyzed by obtaining micro-CT images of the retrieved inserts. The~     components of total volumetric polyethylene loss, including wear associated with the medial~     articular, lateral articular and backside regions of the insert be quantified by comparing~     the worn insert with an unworn control. The investigators hypothesize that the fixed bearing~     inserts where the polyethylene is locked to the metal baseplate will demonstrate more~     volumetric wear than the mobile bearing inserts that are designed to slide or rotate on the~     metal baseplate.~   "
144292|NCT01165944|"~     Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid~     organ transplantation. This disease is difficult to treat as the levels of glycemia~     fluctuate in response to variations in doses of steroid and other immunosuppressive agents.~     At the same time, poorly controlled hyperglycemia affects negatively graft function and~     survival as well as on the ability of the immunocompromised host to fight infections. The~     investigators hypothesize that the addition of Pramlintide (Symlin) to the management of~     patients with PTDM would help patients with post-transplant diabetes attain better control~     at the critical time of titration of immunosuppressive regimens. The primary objective of~     this proposal is to improve glycemic control of diabetes with Pramlintide in patients with~     post-transplant diabetes at 3 and 6 months of therapy.~   "
144293|NCT01165931|"~     The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood~     flow in subjects with coronary artery disease and to compare this effect with the~     intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with~     coronary artery disease.~   "
144294|NCT01165918|"~     The purpose of this study is~        1. To generate human embryonic stem cells lines (hESC) lines~        2. Study of the factors that contribute to differentiation towards germ cell.~   "
144295|NCT01165905|"~     Treatment of cancer is often more effective when two or more drugs are used together. For~     example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational~     anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is~     more inhibition of the growth of the cancer cells compared to either drug used by itself.~     These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer~     in patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is~     an effective combination in patients can be done, doctors must first know what is largest,~     safe dose of ON 01910.Na that can be used in combination with gemcitabine and what is the~     best regimen to use. This study is designed to answer that question.~   "
144296|NCT01165892|"~     The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism~     in magnetic resonance imaging (MRI).~   "
144297|NCT01165879|"~     The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures~     uterine contractions based on the electrical activity of the uterine muscle.The study will~     compare the EUM100pro measurements to the already existing uterine contractions monitors~     (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of~     uterine contractions.~   "
144298|NCT01165866|"~     Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of~     persistent vomiting in patients with acute gastroenteritis.~   "
144299|NCT01165853|"~     The purpose of this study is compare the effects of consuming glucose- and~     fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy~     the body burns as well as effects on blood pressure, hormones, blood triglycerides and~     cholesterol, and the body's sensitivity to the insulin.~   "
144300|NCT01165840|"~     This study will find how weight affects the dosing of a drug called dapsone. Currently, the~     amount of dapsone a patient receives is the same regardless of the patient's weight.~   "
144301|NCT01165827|"~     1. Research aims~           The increasing prevalence of severe aortic valve defects is a corollary to increases in~          life expectancy. For many years, surgical valve replacement with extracorporeal~          circulation has been the gold standard in the treatment of severe aortic valve~          diseases. Every year, about 12,000 patients in Germany receive isolated aortic valve~          surgery. Several alternatives to established procedures have recently emerged:~             -  V-TAVI, vascular transcatheter aortic valve implantation and~             -  A-TAVI, apical transcatheter aortic valve implantation. For some time,~               percutaneous balloon valvuloplasty has been used as a palliative measure for~               specific patients.~           New developments have triggered assumptions that there will over the coming years be a~          certain reorientation to the treatment of patients with aortic valve defects. In a~          positioning paper published jointly by the German Cardiac Society (DGK) and the German~          Society for Thoracic and Cardiovascular Surgery (DGTHG), there is a consensus that~          these new techniques can be used on patients who have either contraindications against~          conventional surgery or who are at high risk of preoperative mortality, e.g. due to~          severe comorbidities.~           As there is as yet only limited experience in this field and neither randomised trials~          nor long-term-results are available, the use of new implantation techniques is~          therefore not recommended for younger patients or patients without comorbidities. There~          is accordingly an urgent need for any introduction of this innovative medical procedure~          to be stringently monitored according to scientific principles. The goal of the planned~          Germany Aortic Valve Register is to evaluate the new treatments from the point of view~          of benefits und risks with respect to the gold standard of conventional surgery, with a~          view to compiling evidence-based indication criteria. The register will furthermore~          allow for the first time a comparison of various operative procedures, such as Ross~          procedure, David procedure and various mechanical or biological aortic valve implants.~        2. Rationale of the study design Randomised trials in controlled environments are~          considered best scientific practice for verifying the efficacy of a new method. The~          disadvantage is that only a small part of potential patients can be included in the~          trial, and results therefore reflect only a small section of the real world.~          Furthermore, a randomised study design is for ethical reasons not an acceptable~          approach to all questions, especially when contraindications exist for a certain branch~          of treatments and the spectrum of treatments is to be expanded. Nevertheless, new~          procedures have to be critically and scientifically analysed if the risk-benefit ratio~          is to be accurately determined. National heath authorities therefore request register~          data in addition to controlled trials in order to verify the safety and efficacy of new~          procedures across larger patient populations.~        3. Objectives~             1. Description of structure, process and outcome quality for the various techniques~               of aortic valve therapies~             2. Definition of indication criteria (e.g. through scoring systems)~             3. Collection of information on quality and safety for special medical devices~             4. Evaluation of quality of care on the level of participating centres with a view to~               increasing quality~             5. Health economic evaluation of the applied treatments~        4. Study design Prospective, controlled, multicenter register study~   "
144302|NCT01165814|"~     Oral naproxen might be more efficacious for post-cesarean pain-control and have better~     side-effects profile than oral tramadol.~   "
144303|NCT01165801|"~     The purpose of this study was to find out if in patients with non-exudative age-related~     macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression~     or progression to exudative AMD could be detected 6 months after surgery.~   "
144304|NCT01165788|"~     1. To explore specific aspects of social adaptation such as social connectedness,~          occupational outcomes and family relationships in lymphoma patients after autologous~          blood or marrow transplantation (BMT).~        2. To investigate how social adaptation varies with time lapsed since BMT and with the~          life stage as determined by patient?s age. Understanding both the positive and negative~          aspects of cancer and cancer therapy leads to opportunities to promote adaptive~          strategies.~   "
144305|NCT01165775|"~     We hope to clarify how betamethasone affects glucose levels in the mother in the days after~     receiving the drug. This understanding will hopefully allow us to better anticipate the risk~     of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal~     glucose to prevent maternal and neonatal complications of hyperglycemia.~   "
144306|NCT01165762|"~     The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone~     marrow Transplantation are enrolling patients into a research study to determine if donor~     stem cells given after a living related one Haplotype match kidney transplantation will~     change the immune system such that immunosuppressive drugs can be completely withdrawn.~   "
144307|NCT01165749|"~     The long term health and cardiovascular benefits of a regular exercise program have been~     well-established. National guidelines recommend involvement in moderate aerobic fitness~     (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic~     cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful~     parameters for risk stratification, and methods of devising individual exercise~     prescriptions are completely lacking. The specific aims of this study are: 1) to devise a~     safe moderate intensity exercise training program in patients with HCM, and 2) to determine~     whether exercise training improves ability to perform activities and tasks, heart size and~     function, and quality of life in patients with HCM.~   "
144414|NCT01164345|"~     The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF~     (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL)~     patients for autologous transplantation.~   "
144311|NCT01165697|"~     Fabry disease, an x-linked recessive lysosomal storage disease (LSD) is commonly recognized~     as a cause of renal failure in involved men and more recently recognized in women too. Women~     are involved in significant numbers and with complications, as are men, of vascular disease.~     This manifests as unexpected strokes in young adults. We have morphologic evidence that~     storage-endotheliopathy induced microvascular disease is the cause of cardiopathy and of~     cryptogenic strokes, and that storage endotheliopathy starts in early life, probably before~     birth. Based on our earlier work with other endotheliopathies such as diabetes mellitus,~     Susac syndrome, and hypertension, we will find and study patients using unique methods,~     neuro-retinal fluorescein angiography (NRFA), that we have developed for this purpose. These~     methods include NRFA to demonstrate capillary perfusion in the optic nerve head and retinal~     quadrants. We anticipate, based on our earlier experience with other endotheliopathies, that~     we will show more vascular pathology earlier than previously reported. Using epidemiologic~     and genetic tools we will find more patients than previously known or expected. It will~     offer opportunity for earlier diagnosis, prognosis, and response to enzyme replacement~     therapy.~      We hypothesize that Fabry disease is a poorly recognized and poorly characterized cause of~     microvascular disease and cryptogenic strokes in young women and men. Neuroretinal capillary~     perfusion abnormalities in Fabry disease will be predictive of equivalent vascular disease~     in kidney, heart, brain and other organs, and further that it will be responsive to change~     induced by enzyme replacement therapy treatment.~   "
144312|NCT01165684|"~     This trial is conducted in Europe, and North and South America. The aim of this clinical~     trial is to investigate if the two treatments are equally effective.~   "
144313|NCT01165671|"~     Treatment standard for patients with primary glioblastoma (GBM) is combined~     radiochemotherapy with temozolomide (TMZ). Radiation is delivered up to a total dose of 60~     Gy using photons. Using this treatment regimen, overall survival could be extended~     significantly however, median overall survival is still only about 15 months.~      Carbon ions offer physical and biological advantages. Due to their inverted dose profile and~     the high local dose deposition within the Bragg peak precise dose application and sparing of~     normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase~     relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending~     on the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which~     is comparable to photons.~      First Japanese Data on the evaluation of carbon ion radiation therapy showed promising~     results in a small and heterogeneous patient collective.~      In the current Phase II-CLEOPATRA-Study a carbon ion boost will be compared to a proton~     boost applied to the macroscopic tumor after surgery at primary diagnosis in patients with~     GBM applied after standard radiochemotherapy with TMZ up to 50 Gy. In the experimental arm,~     a carbon ion boost will be applied to the macroscopic tumor up to a total dose of 18 Gy E in~     6 fractions at a single dose of 3 Gy E. In the standard arm, a proton boost will be applied~     up to a total dose 10 Gy E in 5 single fractions of 2 Gy E.~      Primary endpoint is overall survival, secondary objectives are progression-free survival,~     toxicity and safety.~   "
144314|NCT01165658|"~     The goal of this clinical research study is to study the safety of giving larger daily doses~     of proton radiation therapy than the standard dose levels given to treat lung cancer.~     Researchers want to find the highest daily dose of proton radiation that can be given~     without having to stop therapy due to side effects.~   "
144315|NCT01165645|"~     RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic~     anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic~     effect may boost the immune system to help the body create a better immune response to~     vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir~     together in improving immune response to vaccines in patients with complete remission~     following a bone marrow transplant for Hodgkin lymphoma.~   "
144316|NCT01165632|"~     RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may~     help in guiding surgery and radiation therapy and allow doctors to plan better treatment.~      PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning~     surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade~     malignant glioma~   "
144317|NCT01165619|"~     In this study, we will measure levels of reproductive hormones and metabolic markers in~     subjects with isolated GnRH deficiency disorders and compare them to healthy control~     populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in~     healthy subjects and those with reproductive disorders and (2) to correlate reproductive and~     metabolic phenotypes with genetic changes within patients with reproductive disorders and~     healthy controls.~   "
144318|NCT01165606|"~     This study aimed to determine the impact of providing chest physiotherapy on the duration of~     mechanical ventilation, intensive care length of stay, intensive care and hospital mortality~     in mechanically ventilated patients.~   "
144319|NCT01165593|"~     The purpose of this study is to gather information about the size and shape of patients'~     hearts in order to design a device.~   "
144320|NCT01165580|"~     This open label study will assess the pharmacokinetics and the safety and tolerability of~     Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant~     patients < 4 months of age.~   "
144321|NCT01165567|"~     Background:~      Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased~     morbidity and mortality, particularly in patients with chronic renal insufficiency. Although~     some agents including hydration with saline are being prescribed to prevent renal~     deterioration in these high risk patients, their efficacy is not clear defined and~     debatable. Therefore additional prophylactic pretreatments are needed.~      Methods/Design:~      Present study aims to investigate differences in occurrence of CIN after sarpogrelate~     premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85~     years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to~     one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine~     treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is~     the occurrence of CIN during 4 weeks after receiving contrast agent.~      Discussion:~      As of May 2010, there were no registered trials evaluating the therapeutic potentials of~     sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal~     function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment~     option.~   "
144324|NCT01165528|"~     Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care~     Unit (RICU) of Post Graduate Institute of Medical Education And Research~     (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of~     lack of previous outcome data in such patients, all patients requiring RICU admission for~     acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being~     enrolled in this pilot study.~      The patients meeting the aforementioned criteria will randomly assigned to ventilation with~     assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support~     ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized~     on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence~     will be computer generated. The assignments will placed in sealed opaque envelopes and each~     patient's assignment was made on admission to the RICU by the attending physician. Blinding~     of treatment is not possible.~      All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems,~     Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to~     low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a~     saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30~     cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory~     rate to 35/ min to achieve the above said goals11.These patients will be weaned as per~     standard protocol of spontaneous breathing trial of 30 minutes once they are recognized~     eligible as per statement of the sixth International consensus conference on weaning.~   "
144325|NCT01165515|"~     Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular~     matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin~     induces endothelial cell apoptosis and diminishes cell migration, adhesion and~     proliferation.~      Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease~     involves unwanted tissue growth. By cutting off the blood supply from a plaque the~     likelihood of plaque rupture may eventually be reduced. Recent data indicates that the loss~     of collagen XVIII/endostatin is related to the enhancement of neo-vascularization and~     vascular permeability in atherosclerosis. Plaque neo-vascularization strongly correlates~     with the regional content of inflammatory cells. Furthermore, increased vascular~     permeability enhances lipid accumulation in the vessel walls, hence increasing foam cells.~      Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial~     infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such~     as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after~     myocardial infarction endostatin neutralization displayed adverse left ventricular~     remodeling and severe heart failure compared with controls. Although angiogenesis was~     increased, tissue remodeling and interstitial fibrosis were further exaggerated in~     post-myocardial infarction hearts by endostatin neutralization.~      However, several studies suggest that endostatin may locally modulate coronary collateral~     formation by inhibiting collateral vessel formation in patients with ischemic heart disease.~      During treadmill exercise tests in healthy volunteers a significant increase in circulating~     endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal~     muscles by decreasing endostatin in the muscle tissues to increase blood flow to these~     metabolically active tissues. Thereby endostatin is released into the general circulation.~      In summary, endostatin might be a new weapon to fight against atherosclerotic progression by~     inhibiting neo-vascularization of atherosclerotic plaques.~   "
144326|NCT01165502|"~     The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue~     CM3.1-AC100 after repeated subcutaneous (sc) doses.~   "
144327|NCT01165489|"~     Laryngomalacia is the most common congenital malformation of the larynx. It results from~     abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear~     within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of~     infants with laryngeomalacia have synchronous airway anomalies.~   "
144328|NCT01165476|"~     The purpose of this study is to compare the bioavailability of a single 1mg dose of~     treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent~     facilities.~   "
144329|NCT01165463|"~     This is second-generation study based on results from ACTIVE (Advanced Cognitive Training~     for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy~     and Active Minds Study). The investigators will formally test from an intent-to-treat~     perspective for differences on the primary and secondary outcomes based on whether~     participants were randomized to the basic on-site speed of processing training (SOPT) group~     (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic~     at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training~     involves 10 hours of either the SOPT or attention-control training during the first 6 weeks~     of participation. Booster-training involves 4 additional hours of SOPT training at 11 months~     of participation.~   "
144330|NCT01165450|"~     The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects~     with persistent corneal epithelial defects (PED) resulting from corneal epithelial~     debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns,~     post-PRK, or post-corneal transplant surgery.~   "
144331|NCT01165437|"~     Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD~     are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is~     the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms~     and legs using a Doppler device. The need for dedicated equipment and trained personnel,~     along with the time required to perform the test, have been identified as barriers to~     widespread implementation of ankle-brachial index screening. The use of automated~     oscillometric devices for blood pressure measurement has been applied to leg pressure~     measurement and determination of the ankle-brachial index with variable success. It will be~     beneficial to investigate a reliable oscillometric-based procedure that can accurately~     measure leg pressures for the ankle-brachial index across the entire spectrum of PAD~     severity.~      In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data~     from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms~     derived from the lower extremities as compared to Doppler-based measurements of blood~     pressure. We used signal processing analysis and regression techniques to develop a two-step~     algorithm which will allow for accurate interpretation of oscillometric waveforms in~     normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure~     across the spectrum of peripheral artery disease severity.~      This proposed project will validate this novel oscillometric ABI algorithm in a population~     of patients who have been identified as at risk for PAD and for whom screening ABI has been~     recommended by multiple professional organizations (AHA/ACC and American Diabetes~     Association). Arm, ankle, and toe pressure measurements will be made in the supine position~     using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial~     index and toe-brachial index will be calculated.~   "
144332|NCT01165424|"~     Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center,~     open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be~     administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a~     dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal~     representatives) provided consent to continue treatment beyond 12 weeks will receive~     treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal~     symptom scores, and nasal findings will be evaluated. The presence/absence of serious~     adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the~     follow-up.~   "
144333|NCT01165411|"~     It has been estimated that 90% of bloodstream infections associated with catheters, are due~     to CVCs, and that 500 to 4,000 patients in the United States die annually due to these~     bloodstream infections. The risk of central line associated bloodstream infections is~     typically expressed as the number of line infections per 1000 catheter days. This study's~     goal is to develop a uniform CL protocol, updated practice guidelines based on current~     evidence, and a standard procedural checklist based on CL care bundles recommended by the~     Institute for Healthcare Improvement. A secondary goal is to create a CL registry to capture~     and store data relevant to each CL placed throughout the institution. This registry will~     provide a wealth of data on CL insertions and complications that may be used as a valuable~     source of information for quality assurance, performance improvement, and research. With the~     knowledge and information obtained through this registry, educational offerings can be~     created, and a standardized institutional process for CL insertion can be developed.~   "
144334|NCT01165398|"~     An estimated 250,000 cases of central line-associated bloodstream infections occur in US~     hospitals annually, and an estimated 30,000 to 62,000 patients die as a result, the marginal~     cost of which to the health-care system is approximately $25,000 per episode. Inconsistent~     and outdated clinical practices have been identified as key causative factors. In order to~     improve overall healthcare delivery and outcomes, current and future healthcare~     professionals need to complement their clinical skills with systems-based skills. Specific~     to the problems of central lines, during a 2005 chart review of institutional patient safety~     issues, a LVHN internal quality committee found multiple cases involving the insertion of~     central lines, including cases involving arterial placement and malposition. The internal~     quality committee review revealed that newer residents were primarily involved in these~     cases. As a result of the committee's findings and review of the literature, a standardized~     Central Line Access and Placement course was designed as part of the incoming~     residents'orientation process. This study's goal was to contribute to the knowledge-base of~     health professional education and to build a sustainable model for one set of learning and~     development interventions, with the expectation that findings will have broad relevance for~     patient safety initiatives, health professional training and development programs, and~     healthcare delivery improvement.~   "
144335|NCT01165385|"~     The aim of this research is to evaluate the potential interest of an association of~     Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.~      As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder,~     esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a~     rapid evaluation of this combination, we will evaluate the combination in any patient whose~     tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).~      This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It~     will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include~     around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort~     of triple negative breast cancer patients. If the association is proven to be feasible, we~     will then move to a specific phase II study in triple negative breast cancer patients.~   "
144336|NCT01165372|"~     Background: There are worrying signs from Western Cambodia that parasitological responses to~     artesunate containing treatment regimens for uncomplicated falciparum malaria are slower~     than elsewhere in the world. Delayed parasite clearance and unusually high failure rates~     with artesunate-mefloquine have been reported. These antimalarials are central to current~     treatment strategies and spread of significant resistance outside this area would be a~     global disaster. Radical containment measures are needed. In this context there is an urgent~     need to proceed quickly to investigate whether there is any evidence of resistance to~     artemisinin derivatives in Vietnam.~      Objective: The primary objective is to assess the slope of the decline in the log~     parasitemia-time curve in patients treated with artesunate 2mg/kg/day, artesunate 4mg/kg/day~     or dihydroartemisinin-piperaquine once daily, and to compare the results of this study to~     the pharmacokinetic results and to the recent data from patients in Cambodia and Thailand~     treated with equivalent therapies.~      Methods: The trial will be conducted in Phuoc Long Hospital, Binh Phuoc Province, Vietnam.~     The participants will be febrile patients (aged > 10 years) with slide confirmed~     uncomplicated P. falciparum infection. Patients will be treated with either artesunate~     2mg/kg/day, artesunate 4mg/kg/day or dihydroartemisinin-piperaquine once daily for 3 days.~     Patients on artesunate therapy arms will then receive 3 days of treatment with~     dihydroartemisinin-piperaquine with dosages according to the national guidelines. Clinical~     and parasitological parameters will be monitored over a 42-day follow-up period. The~     pharmacokinetic characteristics of artesunate and dihydroartemisinin will be assessed by~     using a population pharmacokinetic modeling.~   "
144337|NCT01165359|"~     Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is~     being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine~     different doses of the medication to evaluate which dose is the most effective at lowering~     the amount of HCV in the blood.~   "
144338|NCT01165346|"~     Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.~   "
144339|NCT01165333|"~     The aim of the study is to determine the safety of Cilengitide in combination with radiation~     therapy.~   "
144340|NCT01165320|"~     The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in~     Japanese children and adolescents with documented Candida or Aspergillus infections.~   "
144351|NCT01165177|"~     The purpose of this observer-blind study is to evaluate the efficacy, safety and~     immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50~     years.~      Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted~     concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from~     both studies combined will be conducted contingent on each study achieving its objectives.~     The protocol posting of study ZOSTE